Minutes of 322nd Registration Board Meeting Compressed

MINUTES OF 322nd MEETING OF REGISTRATION BOARD
HELD ON 8th & 10th November, 2022
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Item No. Detail of Item Page No
I. Confirmation of Minutes of 321st meeting of Registration Board 2

Meeting
II. Division of Pharmaceutical Evaluation & Registration

a. Pharmaceutical Evaluation Cell (PEC) 3-1645
b. Import & Vet-II Section 1646-1649
III. Miscelleneous cases 1650
Drug Regulatory Authority of Pakistan

T.F. Complex, Mauve Area, G-9/4
Islamabad.
Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 1

322nd meeting of Registration Board was held on 8th and 10th November, 2022 in the Committee
Room, Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The meeting was chaired by Dr.
Obaidullah Director (PE&R Division)/Chairman Registration Board DRAP. The meeting started with
recitation of the Holy Verses.
The Chairman, Secretary and members of Registration Board expressed grief and offered Fateha
on sad demise of one of the worthy member Meritorious Prof. Dr. Rafiq Alam Khan. The Board
appreciated the work and contributions of Prof.Dr. Rafiq Alam Khan and prayed for the eternal peace
of the departed soul. The Board also decided to request DRAP to send recognition letter to family of
Dr. Rafiq Alam Khan for his rendered services.
The Board decided to co-opt following experts on expiration of their tenure, under Rule 24 (6)
of the Drugs (Licensing, Registering & Advertising) Rules, 1976 of the Drugs Act, 1976: -
i. Maj. Gen. (R) Dr. Tahir Mukhtar Sayed, Inspector General (Hospitals), Fauji
Foundation, Rawalpindi
ii. Dr. Qurban Ali, Ex-Director General, National Veterinary Laboratories, Islamabad
The Board also decided to co-opt Mr. Hafiz Bilal Bin Akbar, Deputy Director, Legal Affairs
Division under Rule 24 (6) of the Drugs (Licensing, Registering & Advertising) Rules, 1976 of the
Drugs Act, 1976 on case between M/s Galaxy Pharma, Karachi and M/s AGP, Karachi referred by High
Court of Sindh at Karachi,: -
Following members attended the meeting:
1. Ch. Zeeshan Nazir Bajar, Additional Director (BE&R/PE&R), DRAP. Member/ Secretary
2. Lt. Gen.(R) Prof. Dr. Karamat A. Karamat (HI-M.SI-M), Former Member
Surgeon General Pakistan.
3. Dr. Noor us Saba, Director, Biological Evaluation & Research Division, Member
DRAP
4. Mr. Ali Ahmad Agha, Director, DTL, Quetta Member
5. Mr. Ijaz Alvi, DTL, Rawalpindi Member
6. Mr. Muhammad Aslam, Deputy Draftsman-I, Ministry of law & Justice, Member
Islamabad.
7. Mr. Ghulam Mujtaba, Deputy Director, Representative of IPO Member
8. Mr. Ajmal Sohail Asif, Director, QA&LT Division Member
9. Mr. Abdullah, Representative of Division of MD&MD Member
10. Dr. Imran Khan, Director, DTL, Peshawar Member (online)
11. Dr. Qurban Ali, Ex-Director General, National Veterinary Laboratories, Co-opted Member
Islamabad
12. Dr. Muhammad Akram, Animal Husbandry Commissioner, M/o Co-opted Member
NFS&R
13. Maj. Gen. (R) Dr. Tahir Mukhtar Sayed, Inspector General (Hospitals), Co-opted Member
Fauji Foundation, Rawalpindi (Online)
14. Dr. Shabnam Firdous, Secretary/Registrar, Pakistan Veterinary Medical Co-opted Member
Council
15. Hafiz Bilal Bin Akbar, Deputy Direcor (Legal Affairs Division) for case Co-opted Member
of M/s Galaxy Pharma, Karaci and M/s AGP, Karachi
Mr. Nadeem Alamgir (Pharma Bureau), Hafiz Muhammad Azeem, Mr. Hamid Raza and Mr.
Jalal-ud-Din (PPMA) and Mr. Ziaulhaq & Mr. Amir (PCDA) attended the meeting as observers.

Director, BE&R was assisted by respective Additional Director and Assistant Directors for
presentation of the agenda.
Item No. I: Confirmation of Minutes of 321st meetings of Registration Board.
321st meeting of Registration Board was held on 20th to 22nd September, 2022. Accordingly,
draft minutes of 321st meeting of Registration Board were circulated among all the members of Board
on 19th October, 2022 for perusal/approval/comments (if any) by 24th October, 2022 (10:00 am). No
comments were received by any member by 24th October, 2022. Accordingly, fair minutes were
processed to Chairman, Registration Board for perusal/approval. After approval from Chairman
Registration Board, fair minutes of 321st meeting of Registration Board were circulated among
concerned Divisions / Sections for implementation of decisions.
Decision: Registration Board noted the information and unanimously confirmed the
minutes of 321st meeting of Registration Board.

Item No. II: Division of Pharmaceutical Evaluation & Registration
Pharmaceutical Evaluation Cell (PEC)
Sr. No Name of Evaluator Title

1. Mr. Farooq Aslam Evaluator PEC-I
2. Mr. Ammar Ashraf Awan Evaluator PEC-II
3. Mr. Muhammad Haseeb Tariq Evaluator PEC-III
4. Mst.Farzana Raja Evaluator PEC-IV
5. Mst. Iqra Aftab Evaluator PEC-V
6. Mr. Ishtiaq Shafique Evaluator PEC-VI
7. Dr. Sidra Khalid Evaluator PEC-VII
8. Mr. Muhammad Usman Evaluator PEC-VIII
9. Mr. Adil Saeed Evaluator PEC-IX
10. Mst. Najia Saleem Evaluator PEC-X
11. Dr. Farhadullah Evaluator PEC-XI
12. Mr. Shahid Nawaz Evaluator PEC-XIII
13. Mst. Saima Hussain Evaluator PEC-XV
14. Mr. Akbar Ali Evaluator PEC-XVI
15. Mr. Zia Ullah Evaluator PEC-XVII
16. Mr. Muneeb Ahmed Evaluator PEC-XVIII
17. Mst. Sana Kanwal Evaluator PEC-XX
18. Mr. Muhammad Zubair Assistant Director (PE&R)
19. Mr. Umer Latif
20. Mr. Ahsan Hafiz

Item No. I: Agenda of Evaluator-I (Mr. Farooq Aslam)
Case No. I: Routine applications submitted on Form-5F for Import
1. Name, address of Applicant / Importer M/s Lab Diagnostic System (SMC) Pvt. Ltd. 111B,
Hali road, Westridge 1, Rawalpindi Cantt.
Details of Drug Sale License of importer License No: 01-374-0176-041296D
Address: Lab Diagnostic Systems Pvt. Ltd. 111-B,
Hali road Westridge 1Cantt, District Rawalpindi.
Godown: N/A
Validity: 07-03-2023
Status: License to sell drugs as a distributor
Name and address of marketing M/s Actero Middle East, on the cornor of 8th
authorization holder (abroad) Golestan, Sarvestan Blvd, Baharestan Industrial
Zone, Karaj, Iran.
Name, address of manufacturer(s) M/s Actero Middle East, on the cornor of 8th
Golestan, Sarvestan Blvd, Baharestan Industrial
Zone, Karaj, Iran.
Name of exporting country Iran
Detail of certificates attached (CoPP, Free sale certificate, GMP certificate)
• Original legalized CoPP (No. 665/13204 dated 07/06/2021) issued by Food and Drug
Administration Tehran, Iran. The applied product is available in the market of exporting
country for free sale. The facilities and operations conform to WHO GMP.
Details of letter of authorization / sole agency agreement:
• Copy of letter of authorization is submitted from Actero Middleast wherein M/s Lab
Diagnostic Systems (SMC) is authorized for registration and all other matters pertaining to
registration of the product.
Status of the applicant ☐ Manufacturer
☒ Importer
☐ Is involved in none of the above (contract giver)
Status of application ☐ New Drug Product (NDP)
☒ Generic Drug Product (GDP)
Intended use of pharmaceutical product ☒ Domestic sale
☐ Export sale
☐ Domestic and Export sales
For imported products, specify one the ☒ Finished Pharmaceutical product import
these ☐ Buk import and local repackaging
☐ Buk import and local repackaging for export
purpose only
Dy. No. and date of submission Dy. No.33828 : 28/12/2021
Details of fee submitted PKR 150,000/- : 01/10/2020
The proposed proprietary name / brand Capecitabine ACTe 500mg oral tablet
name
Strength / concentration of drug of Each film coated tablet contains:
Active Pharmaceutical ingredient (API) Capecitabine……500mg
per unit
Pharmaceutical form of applied drug Immediate release film coated tablet
Pharmacotherapeutic Group of (API) Anti-cancer
Reference to Finished product USP
specifications
Proposed Pack size 10’s×10
Proposed unit price As per SRO
The status in reference regulatory Xeloda 500mg tablet, USFDA Approved.
authorities
For generic drugs (me-too status) CAPEGARD-500MG FILM COATED TABLETS
by M/s AJ Mirza Pharma, reg. No. 72593
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO QOS-PD
template. Firm has summarized information related
to nomenclature, structure, general properties,
solubilities, physical form, manufacturers,
description of manufacturing process and controls,
impurities, specifications, analytical procedures and
its validation, detail of impurities and validations
studies, batch analysis and justification of
specification, reference standard, container closure
system and stability studies of drug substance and
product.
Name, address of drug substance M/s Hetero Labs Limited Unit –I Survey No. 10
manufacturer IDA Gaddapotharam Village, Jinaram Mandal,
Sangareddy district, Telangana, India.
Module-III Drug Substance: Official monograph of Capecitabine is present in
USP. Firm has submitted detailed drug substance
data for both sources related to nomenclature,
structure, general properties, solubilities, physical
form, manufacturers, description of manufacturing
process and controls, impurities, specifications,
analytical procedures and its validation, batch
analysis and justification of specification, reference
standard, container closure system and stability
studies of drug substance.
Stability Studies of Drug Substance • Real time stability studies have been conducted
(Conditions & duration of Stability at 25oC±2 and 60%RH±5% for 36 months of 3
studies) batches
• Accelerated stability study is conducted at
40oC±2 and 75%RH±5% for 6 months of 3
batches
Batches: (CA0010910, CA0020910, CA0030910)
Module-III Drug Product: Firm has submitted data of drug product including
its description, composition, pharmaceutical
development, compatibility studies of excipients
with drug substance manufacture, manufacturing
process and process control, process validation
protocols, control of excipients, control of drug
product, specifications, analytical procedures,
validation of analytical procedures, detail of
impurities and the validation studies, batch analysis,
justification of specifications, reference standard or
materials, container closure system and stability.

Pharmaceutical Equivalence and The firm has submitted pharmaceutical equivalence
Comparative Dissolution Profile studies against Xeloda 500mg Tablet by performing
all the quality tests.
Comparative dissolution prodile is submitted
against Xeloda Tablet 500mg batch number X1135
in 4 media that in purified water, acidic pH that is
1.2, Acetate Buffer 4.5pH and Phosphate buffer
6.8pH.
Analytical method The firm has submitted analytical method
validation/verification of product verification / validation studies for drug substance
and drug product including linearity, accuracy,
specificity, force degradation, precision etc.
Container closure system of the drug Forming foil: Clear PVC
product Lidding foil: Aluminium foil
Stability study data of drug product, shelf • Real time stability studies have been conducted
life and storage conditions at 30oC±2 and65%RH±5% for 24 months of 3
batches
• Accelerated stability studies is conducted at
batches
Batches: (T1924, T1925, T1926)
Evaluation by PEC-I:
Observations Response
Name and address of the applicant is different License No: 01-374-0176-041296D
form the name and address mentioned in drug Address: Lab Diagnostic Systems Pvt. Ltd. 111-B,
sale license, please clarify. Furthermore, submit Hali road Westridge 1Cantt, District Rawalpindi.
valid copy of drug sale license. Godown: N/A
Status: License to sell drugs as a distributor
Provide details of the reference product against Brand name: Xeloda tablet 500mg, USFDA
which pharmaceutical equivalence and approved
comparative dissolution profile is submitted Bacth number: X4955B01
including batch number, expiry, date of Mfg by: Roche
manufacturing, name of manufacturer and detail Exp: Sep, 2019
of reference authority where the product is
registered.
Provide detail of container closure system of the Forming foil: Clear PVC
applied product. Lidding foil: Aluminium foil
Provide stability study data (real time & • Real time stability studies have been conducted at
accelerated) of 03 batches till claimed shelf life 30oC±2 and65%RH±5% for 24 months of 3
conducted under the conditions of zone IV-A. batches
• Accelerated stability studies is conducted at
batches
Batches: (T1924, T1925, T1926)
Decision: Approved as per Policy for inspection of Manufacturer abroad and verification of local
storage facility.
Case No. II: Routine applications submitted on Form-5F for local manufacturing
2. Name, address of Applicant / M/s Herbion Pakistan (pvt) Ltd., Industrial triangle,
Marketing Authorization Holder Kahuta road, Humak, Islamabad.
Name, address of Manufacturing M/s Herbion Pakistan (pvt) Ltd., Industrial triangle,
site. Kahuta road, Humak, Islamabad.
Status of the applicant ☒ Manufacturer
☐ Importer
Intended use of pharmaceutical ☐ Domestic sale
product ☐ Export sale
☒ Domestic and Export sales
Dy. No. and date of submission Dy. No. 5850 dated 03/03/2022
Details of fee submitted PKR 30,000/-: dated 07/02/2022
The proposed proprietary name /
Ista-Met Tablet 50/1000mg
brand name
Active Pharmaceutical ingredient Sitagliptin as phosphate monohydrate….. 50mg
(API) per unit Metformin HCl…………………………..1000mg
Pharmaceutical form of applied
Immediate release fiml coated tablet
drug
Pharmacotherapeutic Group of
Anti-diabetic
(API)
Reference to Finished product
Innovator’s specifications
specifications
Proposed Pack size 14’s, 28’s
The status in reference regulatory
USFDA Approved
authorities
For generic drugs (me-too status) Sitaglumet tablet 50/1000 by M/s Hilton Pharma
GMP status of the Finished product Copy of GMP (for govt supply/institution only)
manufacturer certificate no. F.3-9/2018-Addl.Dir(QA&LT)-49
issued on the basis of inspection conducted on
21/05/2019.
Section approval Tablet General Section-Revised
Name and address of API Sitagliptin:
manufacturer. M/s Anhui Haikang Pharmaceutical Co., Ltd.,No. 21,
Huancheng west road, Daguan district, Anqing,
Anhui China.
Metformin:
M/s Aarti Drug limited (unit II) plot no. 211 & 213,
road – 2, GIDC at & post: Sarigam 396 155 Dist:
Valsad Gujarat India.
Module-II (Quality Overall Firm has submitted QOS as per WHO QOS-PD
Summary) template. Summarized information related to
nomenclature, structure, general properties,
its verification, batch analysis and justification of
drug product is submitted.
Module III (Drug Substance) Firm has submitted detailed drug substance data
related to nomenclature, structure, general properties,
solubility, physical form, manufacturers, description
of manufacturing process and controls, impurities,
residual solvents, specifications, analytical
procedures and its complete validation studies, batch
analysis and justification of specification, details of
reference standards, container closure system and
stability studies of drug substance (Sitagliptin and
Metformin).
Stability studies Sitagliptin:
• Real time: 30°C ± 2°C / 65% ± 5%RH for 48
months
• Accelerated: 40°C ± 2°C / 75% ± 5%RH for 6
months
Batches: (20130421, 20130420, 20130419)
Metfromin:
months
months
Batches: (MEF/1510145, MEF/1510146,
MEF/1510147)
Module-III (Drug Product): The firm has submitted detail of manufacturers,
impurities, specifications, analytical procedure and
its validation studies, batch analysis and justification
of specification, reference standard, container closure
system and stability studies of drug product.
Pharmaceutical equivalence and Pharmaceutical equivalence is established against
comparative dissolution profile Sitaglu Met 50/1000mg tablet by Hilton Pharma by
performing all the quality tests. (B:141382)
CDP testing is performed against Sitaglu Met
50/1000mg tablet by Hilton Pharma in all the 03
media that is 0.1N HCl. Acetate Buffer and
Phosphate Bufer.
Analytical method Method validation studies have submitted including
validation/verification of product linearity, range, accuracy/recovery, precision,
specificity, Robustness, system suitability etc.
STABILITY STUDY DATA
Manufacturer of API Sitagliptin:
M/s Anhui Haikang Pharmaceutical Co., Ltd.,No. 21, Huancheng
west road, Daguan district, Anqing, Anhui China.
Metformin:

M/s Aarti Drug limited (unit II) plot no. 211 & 213, road – 2, GIDC
at & post: Sarigam 396 155 Dist: Valsad Gujarat India.
API Lot No. Sitaglptin (20010403)
Metformin (MEF/10010279)
Description of Pack
Alu-Alu blister pakced in secondary unit carton
(Container closure system)
Stability Storage Condition Real time: 30°C ± 2°C / 65% ± 5%RH
Accelerated: 40°C ± 2°C / 75% ± 5%RH
Time Period Real time: 6 months
Accelerated: 6 months
Frequency Accelerated: 0, 3, 6 (Months)
Real Time: 0, 3, 6 (Months)
Batch No. ST-001 ST-002 ST-003
Batch Size 1000 tab 1000 tab 1000 tab
Manufacturing Date 07/2021 07/2021 07/2021
Date of Initiation 21/08/2021 21/08/2021 21/08/2021
No. of Batches 03
Administrative Portion
1. Reference of previous approval of Firm has not submitted any response
applications with stability study
data of the firm (if any)
2. Approval of API/ DML/GMP Sitagliptin: Copy of drug manufacturing license
certificate of API manufacturer number 20190399 valid till 31/12/2025 issued by
issued by concerned regulatory Food and drug administration of Anhui province
authority of country of origin. china is submitted.
Metformin: copy of GMP certificate no. 20031933
valid till 19/03/2023 issued by food and drugs control
administration, Gujarat.
3. Documents for the procurement of Sitagliptin:
API with approval from DRAP (in Copy of attested invoice number WD20200403 dated
case of import). 03/04/2020.
Metformin:
Copy of attested invoice no. EXP/1490/20-21 dated
21/08/2020 is submitted
4. Data of stability batches will be Submitted
supported by attested respective
documents like chromatograms,
Raw data sheets, COA, summary
data sheets etc.
5. Compliance Record of HPLC Submitted
software 21CFR & audit trail
reports on product testing
6. Record of Digital data logger for Submitted
temperature and humidity
monitoring of stability chambers
(real time and accelerated)
Remarks of Evaluator-I:

Sr. Observations Response
No.
1 Provide analytical method verification Firm has submitted analytical method
studies performed by drug product verification report including specificity,
manufacturer for Sitagliptin phosphate linearity, precision and accuracy/recovery
monohydrate. for Sitagliptin drug substance performed by
drug product manufacturer.
2 Provide certificate of analysis for COA for Metformin from drug product
Sitagliptin phosphate monohydrate and manufacturer and drug substance
Metformin HCl drug substances for manufacturer is submitted or batch number
those batches which were used for MEF/10010279.
product development from drug product Potency for Metformin HCl is adjusted
and drug substance manufacturer and considering 100% assay value while the
batch manufacturing record. assay value for Metformin is 99.19% (on as-
is basis).
The firm has stated,”We are committed that
we will positively consider the “AS-Is”
potency adjustment in all upcoming
commercial batches”.
COA for Sitagliptin from drug product

manufacturer and drug substance
manufacturer is submitted or batch number
20010403.
3 As per submitted dossier, titration The provided specifications and test methods
method has been used for assay by drug product manufacturer is of USP
estimation for Metformin HCl while 2020 and the assay of API is conducted by
according to latest edition of USP, HPLC as claimed in the united states’
HPLC method should be used for assay pharmacopoeia.
testing, please clarify.
4 Since CDP and pharmaceutical The firm has submitted CDP and
equivalence testing are performed pharmaceutical equivalence data against the
against Sitaglu Met tablet while the said reference product that is janumet with the
studies are required against innovator’s / following details.
reference products. Brand: Janumet tablet 50/1000
Batch: HM-21497588A
5 The submitted stability data is till 3rd Data till 6th month time point is submitted.
month time point, please submit stability
study data till 6th month.
Decision: Approved.
• Manufacturer will place first three production batches on long term stability studies
throughout proposed shelf life and on accelerated studies for six months as per the
commitment submitted in the registration application.
• Manufacturer will perform process validation of first three batches as per the
• Firm will submit revised specifications of Metformin HCl drug substance according to
latest edition of USP along with the submission of analytical method verifications studies
(including specificity, accuracy and method precision) before the issuance of
registration letter.
• Firm will submit correct calculations for potency adjustment for Metformin HCl
considering the assay value on As-Is basis for commercial batches with the submission
of Rs. 7,500/- for as pre-registration variation fee as per notification No.F.7-11/2021-
B&A/DRAP dated 07-05-2021.
3. Name, address of Applicant / M/s Herbion Pakistan (pvt) Ltd., Industrial triangle,
Marketing Authorization Holder Kahuta road, Humak, Islamabad.
Name, address of Manufacturing M/s Herbion Pakistan (pvt) Ltd., Industrial triangle,
site. Kahuta road, Humak, Islamabad.
☐ Importer
Ista-Met Tablet 50/500mg
brand name
Active Pharmaceutical ingredient Sitagliptin as phosphate monohydrate….. 50mg
(API) per unit Metformin HCl…………………………..500mg
Immediate release film coated tablet
drug
Anti-diabetic
(API)
specifications
USFDA Approved
authorities
For generic drugs (me-too status) Sitaglumet tablet 50/500 by M/s Hilton Pharma
GMP status of the Finished product Copy of GMP (for govt supply/institution only)
manufacturer certificate no. F.3-9/2018-Addl.Dir(QA&LT)-49
issued on the basis of inspection conducted on
21/05/2019.
Section approval Tablet General Section-Revised
Name and address of API Sitagliptin:
manufacturer. M/s Anhui Haikang Pharmaceutical Co., Ltd.,No. 21,
Huancheng west road, Daguan district, Anqing,
Anhui China.
Metformin:
M/s Aarti Drug limited (unit II) plot no. 211 & 213,
road – 2, GIDC at & post: Sarigam 396 155 Dist:
Valsad Gujarat India.

Metformin).
Stability studies Sitagliptin:
months
months
Batches: (20130421, 20130420, 20130419)
Metfromin:
months
months
Batches: (MEF/1510145, MEF/1510146,
MEF/1510147)
comparative dissolution profile Sitaglu Met 50/500mg tablet by Hilton Pharma by
performing all the quality tests. (B:141388)
CDP testing is performed against Sitaglu Met
50/500mg tablet by Hilton Pharma in all the 03 media
that is 0.1N HCl. Acetate Buffer and Phosphate
Bufer.
Manufacturer of API Sitagliptin:
M/s Anhui Haikang Pharmaceutical Co., Ltd.,No. 21, Huancheng
west road, Daguan district, Anqing, Anhui China.
Metformin:
M/s Aarti Drug limited (unit II) plot no. 211 & 213, road – 2, GIDC
at & post: Sarigam 396 155 Dist: Valsad Gujarat India.
API Lot No. Sitaglptin (20010401)
Metformin (MEF/10010279)
Description of Pack
Batch No. ST-001 ST-002 ST-003
No. of Batches 03
8. Approval of API/ DML/GMP Sitagliptin: Copy of drug manufacturing license
certificate of API manufacturer number 20190399 valid till 31/12/2025 issued by
issued by concerned regulatory Food and drug administration of Anhui province
authority of country of origin. china is submitted.
Metformin: copy of GMP certificate no. 20031933
valid till 19/03/2023 issued by food and drugs control
9. Documents for the procurement of Sitagliptin:
API with approval from DRAP (in Copy of attested invoice number WD20200403 dated
case of import). 03/04/2020.
Metformin:
Copy of attested invoice no. EXP/1490/20-21 dated
21/08/2020 is submitted
data sheets etc.

No.
1 Provide analytical method verification Firm has submitted analytical method
studies performed by drug product verification report including specificity,
manufacturer for Sitagliptin phosphate linearity, precision and accuracy/recovery
monohydrate. for Sitagliptin drug substance performed by
2 Provide certificate of analysis for COA for Metformin from drug product
Sitagliptin phosphate monohydrate and manufacturer and drug substance
Metformin HCl drug substances for manufacturer is submitted or batch number
those batches which were used for MEF/10010279.
product development from drug product Potency for Metformin HCl is adjusted
and drug substance manufacturer. considering 100% assay value while the
assay value for Metformin is 99.19% (on as-
is basis).
COA for Sitagliptin from drug product

manufacturer and drug substance
manufacturer is submitted or batch number
20010403.
3 As per submitted dossier, titration The provided specifications and test methods
method has been used for assay by drug product manufacturer is of USP
estimation for Metformin HCl while 2020 and the assay of API is conducted by
according to latest edition of USP, HPLC as claimed in the united states’
HPLC method should be used for assay pharmacopoeia.
testing, please clarify.
4 Since CDP and pharmaceutical The firm has submitted CDP and
equivalence testing are performed pharmaceutical equivalence data against the
against Sitaglu Met tablet while the said reference product that is janumet with the
studies are required against innovator’s / following details.
reference products. Brand: Janumet tablet 50/500
Batch: 21495023A
5 The submitted stability data is till 3rd Data till 6th month time point is submitted.
month time point, please submit stability
study data till 6th month.
Decision: Approved.
considering the assay value on As-Is basis for commercial batches with the submission
of Rs. 7,500/- for as pre-registration variation fee as per notification No.F.7-11/2021-

4. Name, address of Applicant / M/s Dyson Research Laboratories Pvt. Ltd., 28-km,
Marketing Authorization Holder Ferozepur road, Lahore, Pakistan.
Name, address of Manufacturing M/s Dyson Research Laboratories Pvt. Ltd., 28-km,
site. Ferozepur road, Lahore, Pakistan.
☐ Importer
Status of application ☐ New Drug Product (NDP)+
Vidora Pro 50/500mg tablet
brand name
Active Pharmaceutical ingredient Vildagliptin…….50mg
(API) per unit Meformin HCl…500mg
drug
Anti-diabetic
(API)
specifications
The status in reference regulatory Galvumet 50/500 by M/s Novartis Pharmaceuticals
authorities Australia TGA Approved.
For generic drugs (me-too status) Galmet 50/500mg tablet by M/s Vision Pharma Reg.
No. 81905
GMP status of the Finished product DML renewal letter no. F.1-7/2003-Lic(Vol-IV) dated
manufacturer 08/06/2021.
Section approval Tablet General Section
Name and address of API Vildaglptin:
manufacturer. Fuxin long rui Phramaceutical Co., Ltd., fluoride
industrial park, Fumeng County (Yi Ma Tu) Fuxin
City, Liaoning province, China.
Metformin HCl:
Aarti drugs Lmted, plot no. 211-213, road no. 2 GIDC
Sarigam, District Valsad, Gujarat, India.
solubilities, physical form, manufacturers, description
specifications, analytical procedures and its
verification, batch analysis and justification of
system and stability studies of drug substance and drug
product is submitted.
Module III (Drug Substance) Official monograph for Metformin HCl Is present in
USP and Vildagliptin is not a pharmacopeoial drug
substance. Firm has submitted detailed drug substance
data related to nomenclature, structure, general
properties, solubility, physical form, manufacturers,
impurities, residual solvents, specifications, analytical
stability studies of drug substance
(Mtformin+Vildagliptin).
Stability studies Vildagliptin:
months
months
Batches: (20160927, 20161031, 20161123)
Metformin HCl:
months
months
Batches: (MEF/1410027, MEF/1410028,
MEF/1410029)
impurities, specifications, analytical procedure and its
validation studies, batch analysis and justification of
Pharmaceutical equivalence and Brand name: Viptin Met 50/500mg
comparative dissolution profile Batch: 002F
Mfg by: M/s Sami Pharmaceuticals
CDP in all the three media with acceptable F2 values

and pharmaceutical equivalence by performing quality
tests are submitted.
specificity, LOD/LOQ, Robustness, Solution stability,
system suitability for drug substance and drug product.
Manufacturer of API Vildaglptin:

Fuxin long rui Phramaceutical Co., Ltd., fluoride industrial park,
Fumeng County (Yi Ma Tu) Fuxin City, Liaoning province, China.
Metformin HCl:
Aarti drugs Lmted, plot no. 211-213, road no. 2 GIDC Sarigam, District
Valsad, Gujarat, India.
API Lot No. Vildagliptin:
WT-20190213-D01-WT03-01
Metformin:
MEF/18102464
Description of Pack
Alu-Alu blister of 10’s packed in printed unit carton.
Batch No. T01 T02 T03
Manufacturing Date Jan, 2020 Jan, 2020 Jan, 2020
No. of Batches 03
1. Reference of previous approval of No response is submitted.
2. Approval of API/ DML/GMP Vildaglitpin:
certificate of API manufacturer Copy of GMP certificate valid till 27/09/2020 issued by
issued by concerned regulatory Fuxin Food and Drug Adninistration is submitted.
authority of country of origin. Metformin:
copy of GMP certificate no. 20031933 valid till
19/03/2023 issued by food and drugs control
3. Documents for the procurement of Metformin:
API with approval from DRAP (in Copy of invoice number EXP/289/19-20 dated
case of import). 06/05/20219 cleared on 16/05/2019 vide dy. No. 6854.
Vildagliptin:
Copy of invoice number SY190311C dated 11/03/2019
cleared on 20/03/2019 vide dy. No. 3869.
data sheets etc.

6.Record of Digital data logger for Submitted
Remarks OF Evaluator-I:
No.
1 Please provide valid copies of GMP Vildaglitpin:
certificates of drug substance Copy of GMP certificate valid till 27/09/2020
manufacturers of Metformin HCL and issued by Fuxin Food and Drug Adninistration
Vildagliptin. is submitted.
Metformin:
copy of GMP certificate no. 20031933 valid
till 19/03/2023 issued by food and drugs
control administration, Gujarat.
2 Provide stability study data (Real Vildagliptin:
Time & Accelerated) of 3 batches • Real time: 30°C ± 2°C / 65% ± 5%RH for
conducted under the conditions of 36 months
zone VI-A for Metformin HCl and • Accelerated: 40°C ± 2°C / 75% ± 5%RH
Vildagliptin. for 6 months
Batches: (20160927, 20161031, 20161123)
Metformin HCl:
• Real time: 30°C ± 2°C / 65% ± 5%RH for
48 months
• Accelerated: 40°C ± 2°C / 75% ± 5%RH
for 6 months
Batches: (MEF/1410027, MEF/1410028,
MEF/1410029)
3 Please clarify since the analytical We have conducted the studies back in 2019-
method used for Metformin Drug 2020, at that time UV method was mentioned
substance is Titration method while in pharmacopoeia, the HPLC method is
the drug substance is compendial and published in latest version (2022), we do
official monograph is present in latest undertake that for commercial manufacturing
pharmacopoeia. we will perform testing as per latest version.
4 Provide pharmaceutical equivalence Brand name: Viptin Met 50/500mg
studies and comparative dissolution Batch: 002F
profile against the reference / Mfg by: M/s Sami Pharmaceuticals
innovator’s product by performing all
the quality tests along with the details
CDP in all the three media with acceptable F2
of manufacturer, batch number, expiry values and pharmaceutical equivalence by
and manufacturing details. performing quality tests are submitted.
5 Provide documents for theMetformin:
procurement of API (Vildagliptin + Copy of invoice number EXP/289/19-20 dated
Metformin HCl) with approval from 06/05/20219 cleared on 16/05/2019 vide dy.
DRAP (in case of import). No. 6854.
Vildagliptin:
Copy of invoice number SY190311C dated
11/03/2019 cleared on 20/03/2019 vide dy.
No. 3869.
6 Provide complete batch The firm has submitted BMR of the applied
manufacturing record of the applied product.
product along with the calculation for Potency for Vildagliptin is adjusted by
potency adjustment. considering 100.18% assay value whereas in
case of assay more than 100 percent, factor of
100 should be taken for calculations. (50mg
with 100% assay & 49.91mg when 100.18%
assay value is considered).
Decision: Approved.
(including specificity, accuracy and method precision) before the issuance of registration
letter.
considering the assay value on As-Is basis for manufacturing of commercial batches with
the submission of Rs. 7,500/- for as pre-registration variation fee as per notification
No.F.7-11/2021-B&A/DRAP dated 07-05-2021.
5. Name, address of Applicant / M/s MartinDow Limited, plot no. 37, Sector 19,
Marketing Authorization Holder Korangi Industrial area, Karachi.
Name, address of Manufacturing M/s MartinDow Limited, plot no. 37, Sector 19,
site. Korangi Industrial area, Karachi.
☐ Importer
Migbet PR Tablet 50mg
brand name
Strength / concentration of drug of Each Prolonged Release, Film Coated Tablet contains:
Active Pharmaceutical ingredient Mirabegron…….50mg
(API) per unit
Pharmaceutical form of applied drug Prolonged Release, Film Coated Tablet
Pharmacotherapeutic Group of Beta-3 adrenergic agonist (used for treatment of
(API) overactive bladder-OAB)
In-House
specifications
Proposed Pack size 2×5’s
USFDA Approved
authorities

For generic drugs (me-too status) Mibega by Getz Pharma, Reg. No. 089378
GMP status of the Finished product Last inspection report dated 07/04/2020, Good Level of
manufacturer compliance
Section approval Tablet Section (General)
Name and address of API M/s Jiangxi synergy Pharmaceutical Co., Ltd., Jiangxi
manufacturer. Fengxin Industrial Park, Fengxin, Jiangxi Province
China.
Module III (Drug Substance) Mirabegron is non-pharmacopoeial drug substance.
Firm has submitted detailed drug substance data related
solubility, physical form, manufacturers, description of
manufacturing process and controls, impurities,
residual solvents, specifications, analytical procedures
and its complete validation studies, batch analysis and
justification of specification, details of reference
standards, container closure system and stability
Stability studies • Real time: 30°C ± 2°C / 65% ± 5%RH for 36
months
months
Batches: (20180101V, 20180102V, 20180103V)
Pharmaceutical equivalence and Pharmaceutical equivalence is provided against
comparative dissolution profile Betigma 50mg PR tablet by M/s Astellas Pharma
Europe B.V (Batch Number: 19E2027) by performing
all the quality tests including tests for impurities (MBL-
ATAH, unspecified impurity, Total Impurity). CDP is
submitted against the same product.
Analytical method Analytical method verification / validation studies for
validation/verification of product drug substance as well as for drug product is submitted.
Manufacturer of API M/s Jiangxi synergy Pharmaceutical Co., Ltd., Jiangxi Fengxin
Industrial Park, Fengxin, Jiangxi Province China.

API Lot No. 20200601V
Description of Pack Au-Alu blister cards made up of cold forming foil (base foil) and
(Container closure system) Aluminium foil (lid foil) packed in unit carton.
Batch No. NPD-T-1607-S NPD-T-1627-S NPD-T-1628-S
Manufacturing Date 29-07-2021 16-08-2021 16-08-2021
Date of Initiation 28-04-2021 24-08-2021 24-08-2021
No. of Batches 03
1. Reference of previous approval of Empator-M tablet 5mg+500mg (Empaglilozin +
applications with stability study data Metformin HCl) approved in 312th meeting of
of the firm (if any) Registration Board.
2. Approval of API/ DML/GMP Copy of GMP certificate No. 2022001 valid till
certificate of API manufacturer 09/01/2027 issued by Jiangxi API Engineering
issued by concerned regulatory Technology Research Centre, China.
authority of country of origin. Copy of GMP certificate No. 2020002 issued by CFDA
valid till 11/03/2025.
3. Documents for the procurement of
API with approval from DRAP (in Copy of attested invoice number JXSG200935 is
case of import). submitted dated 09/10/2020 Dy. Number 3097.

documents like chromatograms, Raw
data sheets, COA, summary data
sheets etc.
software 21CFR & audit trail reports
on product testing
temperature and humidity monitoring
of stability chambers (real time and
accelerated)
No.
1 Please provide valid GMP certificate of Copy of GMP certificate No. 2022001
Drug Substance manufacturer. valid till 09/01/2027 issued by Jiangxi
API Engineering Technology Research
Centre, China.

2 Justify the dissolution parameters selected The firm has referred to USFDA
for the applied product including the limits dissolution database available on the
set for release of drug along with the official website.
discussion for time points selected for USP I (basket), Phosphate Buffer pH 6.8,
testing (i.e 3hours, 5hours & 8.5hours). 900mL, sampling time: 3hr, 5hr, 8.5hr.
3 Acceptance criteria for specificity parameter Acceptance criteria has been set ≤ 5.0%
of analytical method validation studies for that is for force degradation study in
drug product includes limit for degradation specificity to control the degradation as
which is ≤5% while the specification of more degradation can cause non-
product includes total impurity limit ≤0.8%. homogenous peak (impure peak with
Please justify the criteria set for specificity purity angle > threshold angle) in assay
testing which is way broader than the or degradation peaks can interfere
product’s specifications. Moreover, provide elution zone of active. Force
protocols for analytical method validation degradation study is conducted for
studies for the drug product. assay specificity. While 5.0%
degradation justifiable according to
stability significant change criteria in
assay.
4 The submitted stability data is till 3rd month The firm has submitted stability
time point, please provide stability studies summary sheets till 6 months for
till 6th month time point as per the guidelines accelerated and long term stability
provided in 293rd meeting of Registration studies along with the relevant
Board. documents.
5 Provide certificate of analysis of relevant Copy COAs for batch number from drug
batch of drug substance used for product product manufacturer as well as from
development from drug substance drug substance manufacturer is
manufacturer and drug product submitted for batch number 20200601V.
manufacturer.
6 Provide documents for the procurement (e.g Copy of attested invoice number
invoice) of API with approval from DRAP JXSG200935 is submitted dated
(in case of import). 09/10/2020 Dy. Number 3097.
7 Provide complete batch manufacturing The firm has submitted complete batch
record for the applied product. manufacturing record for the applied
product.
Decision: Approved with innovator’s specifications. Registration Board further decided that
registration letter will be issued after submission of fee Rs. 7,500/- for revision of specifications as
per notification No.F.7-11/2021-B&A/DRAP dated 07-05-2021.
• Manufacturer will perform process validation of first three batches as per the commitment
submitted in the registration application.
6. Name, address of Applicant / M/s MartinDow Limited, plot no. 37, Sector 19,
Marketing Authorization Holder Korangi Industrial area, Karachi.
Name, address of Manufacturing M/s MartinDow Limited, plot no. 37, Sector 19,
site. Korangi Industrial area, Karachi.
☐ Importer
Empator-M XR Tablet 25mg+1000mg
brand name
Strength / concentration of drug of Each film coated, extended release tablet contains:
Active Pharmaceutical ingredient Empagliflozin (immediate release)……..25mg
(API) per unit Metformin HCL (extended release)…….1000mg
Pharmaceutical form of applied drug Film coated, extended release tablet
Antidiabetic
(API)
specifications
Proposed unit price AS per SRO
USFDA Approved.
authorities
For generic drugs (me-too status) Xenglu-Met XR tablet by Hilton Pharma
GMP status of the Finished product Copy of GMP certificate No. 85/2020-DRAP(K)
manufacturer issued on the basis of inspection conducted on
07/05/2019
Section approval Table tgeneral section (Regularised)
Name and address of API Empagliflozin:
manufacturer. RUYUAN HEC Pharm Co., Ltd. Xiaba Development
Zone, Ruyuan County, Shaoguan City, Guangdong
Province, P.R. China
Metformin HCl:
IPCA Laboratories Limited, H-4, MIDC, Waluj
Aurangabad431136 Maharashtra India.
Module III (Drug Substance) Firm has submitted detailed drug substance data related
studies of drug substances (i.e Metformin &
Empagliflozin).
Stability studies Stability study conditions:
Empagliflozin:
Real time: 25°C ± 2°C / 60% ± 5%RH for 24 months
Accelerated: 40°C ± 2°C / 75% ± 5%RH for 6 months
Batches: EGLZ-20160501, EGLZ-20160502, EGLZ-
20160503
Metformin HCl:
Batches: 9002ML2RMI, 9003ML2RMI,
9004ML2RMI
Pharmaceutical equivalence and Pharmaceutical equivalence studies have been
comparative dissolution profile submitted against the innovator’s product that is
Synjardy XR tablet 25/1000mg mfg by Boehringer
Ingelheim USA (Batch number: 3189877) by
performing all the quality tests.
Comparative dissolution profile is submitted agaisn the
innovator’s product that is Synjardy XR Tablet
(25/1000mg) in 0.1N HCL, Phosphate Buffer and
Acetate Buffer. F2 values are in acceptable range.
Analytical method Analytical method verification / validation studies for
validation/verification of product drug substance as well as for drug product is submitted.
Manufacturer of API Empagliflozin:
RUYUAN HEC Pharm Co., Ltd. Xiaba Development Zone, Ruyuan
County, Shaoguan City, Guangdong Province, P.R. China
Metformin HCl:
IPCA Laboratories Limited, H-4, MIDC, Waluj Aurangabad431136
Maharahtra India.
API Lot No. Empagliflozin: EGLZ-RD202004002
Metformin: 21060ML2ARMI
Description of Pack
Alu-Alu blisters packed in unit carton
Batch No. NPD-T-1573-S NPD-T-1616-S NPD-T-1617-S
Batch Size 4000 tablet 4000 tablet 4000 tablet
Manufacturing Date 07/07/2021 04/08/2021 07/07/2021
No. of Batches 03
1. Reference of previous approval of Empator-M tablet 5mg+500mg (Empaglilozin +
applications with stability study data Metformin HCl) approved in 312th meeting of
of the firm (if any) Registration Board.
2. Approval of API/ DML/GMP Empagliflozin:
certificate of API manufacturer Copy of GMP Certificate for RUYUAN HEC Pharm
issued by concerned regulatory Co., Ltd. (Certificate: 2018024) issued by Shaoguan
authority of country of origin. Food and Drug Administration & valid upto 04-12-
2021 is submitted.
Metformin HCl:
Copy of GMP certificate No. New-WHO-
GMP/Cert/AD/67318/2018/11/24741 issued on
28/08/2018 valid till 27/08/2021.
3. Documents for the procurement of Empagliflozin: Firm has submitted copy of attested
API with approval from DRAP (in invoice (invoice# WIS200034) Dated: 16/04/2020 dy.
case of import). No. 499 dated 04/05/2020.
Metformin HCl: Copy of attested Invoice No.
MEG2122/1630115 dated 02/04/2021 (diary No. 4247
dated 07/04/2021) imported from IPCA Laboratories
limited attested by DRAP Karachi.
sheets etc.
on product testing
6. Record of Digital data logger for Record of digital data logger for temperature and
temperature and humidity monitoring humidity monitoring of stability chambers (real time
of stability chambers (real time and and accelerated) is submitted.
accelerated)
No.
1 The submitted stability data is till 3rd The firm has submitted stability summary
month time point, please provide sheets till 6 months for accelerated and long
stability study data till 6th month time term stability studies along with the relevant
point. documents.
2 As per submitted dossier, titration “The method used for assay estimation of
method has been used for assay Metformin for finished product by FPP
estimation for Metformin HCl while manufacturer is HPLC as per latest edition
according to latest edition of USP, HPLC of USP. API manufacturer has used titration
method should be used for assay testing, method for assay estimation owing to the
please clarify. previous version of USP monograph”.
3 Provide complete batch manufacturing Complete batch manufacturing record is
record for the applied product. submitted.
4 As per submitted dossier, dissolution The Dissolution testing for Metformin HCl
tests for Metformin core before coating was performed at core stage before coating
has not been performed. Clarification is and results were well within specified limits.
required for not establishing the Since Metformin HCl in all strength have
dissolution profile for the tablet core. same label claim and same formulation,
therefore dissolution profile is performed on
film coated stage on risk basis. Satisfactory
initial and stability results are also evident
on Metformin HCl dissolution performance.
Following core stage results are also
attached herewith.
Batch No. NPD-T-1108-T (Empagliflozin
5mg + Metformin HCl 1000 mg XR Tablet)
Batch No. NPD-T-1107-T (Empagliflozin
12.5mg + Metformin HCl 1000 mg XR
Tablet)
5 Provide detail of manufacturing method The firm has submitted complete batch
for the applied product. manufacturing record for the applied
product.
6. Scientific justification is require regarding addition of 100% overage for Empagliflozin
for compensating the loss during coating.
Response:
Empagliflozin + Metformin HCl 25 + 1000 mg XR tablet is an API (Empagliflozin) coated
tablet. Hence, the API is part of the coating suspension. As per label claim, 25 mg of
Empagliflozin is coated on the tablet as mentioned in the Batch Production Record of
Empagliflozin + Metformin HCl 25 + 1000 mg XR tablet, pp# 25 and is evident through the
tablet weight that is 1479.0 mg, pp #43 95mg was coated on the tablet of 1384.0 mg thus taking
it to 1479.00mg. Breakup is given below:
API Coating
S.No. Raw Material Quantity/tablet Quantity/Batch
1 Empagliflozin 25.000 mg 250.000 g
2 Sheffcoat D white 5Y00692 42.000 mg 420.000 g
3 Talc 3.000 mg 30.000 g
4 Polysorbate 80 (Tween 80) 20.000 mg 200.000 g
5 Polyethylene Glycol 6000 5.000 mg 500.000 g
Thus, no overages of the API are added which can be seen via the content increase of tablet
before and after API coating mentioned above.
• The 100% excess quantity mentioned in the BPR is for the clarity of the reviewer and the
document itself.
• Excess quantity was added in coating material i.e., Sheffcoat D white 5Y00692,
Polyethylene Glycol 6000, Talc, Polysorbate 80 (Tween 80) along with it is the API
Empagliflozin to compensate for the process loss faced while Coating operation is being
carried out, as it is an API coated tablet.
As it is understood that losses are observed/experienced during coating and thus extra quantities
are added as a recompense. These extra quantities do not become part of the final film coated
product, as is evident in the Assay results of Empagliflozin which are well within limits as per
label claim.
Decision: Registration Board deferred the case for;
• Scientific justification regarding addition of 100% overage for Empagliflozin for
compensating the loss during coating.
• Clarification for not establishing the dissolution profile of the extended release core tablet
before coating.
7. Name, address of Applicant / M/s Dynatis Pakistan (Pvt.) Ltd.
Marketing Authorization Holder Plot No. 710, Sunder Industrial Estate, Lahore
Name, address of Manufacturing M/s Dynatis Pakistan (Pvt.) Ltd.
site. Plot No. 710, Sunder Industrial Estate, Lahore
☐ Importer
Gliflo-Met 5/500mg tablet
brand name
Active Pharmaceutical ingredient Empagliflozin…………….5mg
(API) per unit Metformin HCl…………...500mg
Immediate release Film coated tablet
drug
Pharmacotherapeutic Group of Drugs used in diabetics (Combination of oral blood
(API) glucose lowering drugs)
Innovator’s
specifications
Synjardy (5/500mg) tablet, USFDA Approved.
authorities
For generic drugs (me-too status) Empagen 5/500 tablet by M/s Ferozsons.
GMP status of the Finished Copy of GMP certificate No. 29/2021-DRAP(FID-
product manufacturer 2065251-174) issued on the basis of inspection
conducted on 26/03/2021.
manufacturer. M/s Anhui Haikang Pharmaceutical Co., Ltd., No. 21
Huancheng west road, Anqing city, Anhui Province,
246000 China
Metformin HCl:
M/s Shouguang Fukang Pharmaceutical Co., Ltd.,
North East of Dongwaihuan road, Dongcheng Industrial
Area, Shouguang city, Shandong Province, China.
nomenclature, structure, general properties, solubilities,
physical form, manufacturers, description of
specifications, analytical procedures and its verification,
batch analysis and justification of specification,
reference standard, container closure system and
stability studies of drug substance and drug product is
submitted.
specifications, analytical procedures and its complete
specification, details of reference standards container
closure system and stability studies of drug substances.
Stability studies Empagliflozin:
months
months
Batches: (20160301, 20160302, 20160303)
Metformin HCl:
• 48 months real time stability studies conducted at
30°C ± 2°C / 65% ± 5%RH of 03 batches.
• 06 months accelerated stability studies conducted
at 40°C ± 2°C / 75% ± 5%RH of 03 batches
Batches: A-71411106004, A-71411106005, A-
71411106006
Pharmaceutical equivalence and Pharmaceutical Equivalence have been established
comparative dissolution profile against the Jardiance Tablet 10mg by M/s Boehringer
Ingelheim Pharmaceuticals, Inc. Ridgefield, USA. by
performing quality tests (Identification, Assay,
Dissolution).
CDP has been performed against the same brand that
Jardiance Tablet 10mg by M/s Boehringer Ingelheim
Pharmaceuticals, Inc. Ridgefield, USA. in HCl buffer
pH 1.2, Acetate Buffer pH 4.5 and Phosphate buffer pH
6.8. Calculation for f2 value is not required since the
release is more than 85% in 15 minutes for innovator’s
as well as the applied product.
Analytical method validation/ Method validation / verification studies have submitted
verification of product including accuracy/recovery, precision, specificity etc
for drug substance and drug product is submitted.
M/s Anhui Haikang Pharmaceutical Co., Ltd., No. 21 Huancheng west
road, Anqing city, Anhui Province, 246000 China
Metformin HCl:
M/s Shouguang Fukang Pharmaceutical Co., Ltd., North East of
Dongwaihuan road, Dongcheng Industrial Area, Shouguang city,
Shandong Province, China.
API Lot No. 20190703
Description of Pack
Alu-Alu blister strips pack packed in unit carton with leaf insert
Batch No. TCZ-002 TCZ-003 TCZ-004
Batch Size 2500 tablets 2500 tablets 2500 tablets
Manufacturing Date 10-2020 10-2020 10-2020
No. of Batches 03
certificate of API manufacturer Copy of drug manufacturing license no. 20190399 valid
issued by concerned regulatory till 31/12/2025 is submitted.
authority of country of origin. Metformin HCl:
Copy of GMP certificate No. SD20190888 valid till
12/03/2024 is submitted by the applicant.
3. Documents for the procurement of Empagliflozin:
API with approval from DRAP (in Copy of attested invoice No. IND-19-0404, dy. No.
case of import). 14544/2019DRAP dated 11-11-2019.
Metformin HCl:
Copy of attested invoice no. 419FK07Z057 dy. No.
11177/2019DRAP dated 22-08-2019.
data sheets etc.

Remarks of Evaluator:
no.
1 The official monograph of Metformin The firm has stated that B.P monograph
HCl (drug substance) is present in USP-43 have been adopted for the said testing
wherein the HPLC method of analysis for which is titration method by drug product
assay of active has been described, manufacturer as well as by the drug
whereas you have used titration method substance manufacturer.
for the analysis. Therefore, a clarification
is required for not performing the analysis
by HPLC method or otherwise submit the
said performance using HPLC method for
analysis of Metformin drug substance.
2 The test for specificity parameter of We have done stressed studies using
analytical method validation studies for following conditions.
drug product is performed by taking Acid-Base Hydrolysis, oxidation and heat
placebo solution while it should have been treatment
performed by spiking, please clarify. If impurity or degradation product
standards are not available, specificity
testing may be demonstrated by comparing
the test results of samples containing
impurities or degradation products to a
second well characterized procedure. This
should include samples stored under
relevant stress conditions that is light, heat,
humidity, acid/base hydrolysis, oxidation
(ICH Q1R2).
3 Please provide real time stability data of The firm has submitted real time stability
Metformin HCl drug substance conducted data for Metformin drug substance for 60
under the conditions of zone IV-A. months under the conditions of zone IV-A
of 03 batches.
4 Provide batch number, expiry and date of Reference product: Synjardy 5/500mg
manufacturing of the reference product tablet
(Synjardy) against which the Bacth no.: C84685
pharmaceutical equivalence of the applied EXiry: May, 2023
product is established. Mfg by: Boehringer Ingelheim
5 Provide the quantities (with rational) used for the preparation of 70%, 80%, 100%,
120% etc dilutions of sample solution for testing the accuracy/linearity parameters of
validation studies for drug product.
Empagliflozin (Linearity):
Concentration Concentration
(%) (ppm)
70 3.5
80 4
90 4.5
100 5
110 5.5
120 6
130 6.5
Metformin (Linearity):

Concentration Concentration
(%) (ppm)
70 700
80 800
90 900
100 1000
110 1100
120 1200
130 1300
Accuracy:
Concentration Concentration (mg) Concentration (mg)
(%) Empagliflozin Metformin
80 4mg 800
100 5mg 1000
120 6mg 1200
*Each sample concentration was dissolved in 100mL of solvent.
6 Provide batch manufacturing record of all The firm has submitted complete batch
the 03 stability batches along with the manufacturing record along with the
calculations for potency adjustment potency adjustment.
considering the assay values
(Empagliflozin 99.8% & Metformin
100.7%) of drug substances.
Decision: Approved.
letter along with the submission of Rs. 7,500/- as pre-registration variation fee as per
notification No.F.7-11/2021-B&A/DRAP dated 13-07-2021.
8. Name, address of Applicant / M/s Pharmevo (Pvt) Ltd., A-29, North Wesyern Industrial Zon
Marketing Authorization Holder Port Qasim Karachi.
Name, address of Manufacturing M/s Pharmevo (Pvt) Ltd., A-29, North Wesyern Industrial Zon
site. Port Qasim Karachi.
☐ Importer
The proposed proprietary name / Erli Plus 12.5/850mg Tablet

brand name
Active Pharmaceutical ingredient Empagliflozin………..12.5mg
(API) per unit Metformin HCl………850mg
drug
Anti-diabetic
(API)
specifications
Synjardy 12.5/850mg, EM approved.
authorities
For generic drugs (me-too status) Xenglu-met tablet by M/s Hilton Pharma
GMP status of the Finished product Copy of GMP certificate No. 119/2020-DRAP(K) issued on th
manufacturer basis of inspection conducted on 16/09/2020.
manufacturer. M/s Jiangsu Yongan Pharmaceutical Co., Limited, No. 18, 23
provincial road, economic development zone, Huaian Jiangs
China.
Metformin HCl:
M/s Shouguang Fukang Pharmaceutical co. ltd., North-east o
Dongwaihuan road, Dongchend Industrial area, China.
Module-II (Quality Overall Firm has submitted QOS as per WHO QOS-PD templat
Summary) Summarized information related to nomenclature, structur
general properties, solubilities, physical form, manufacturer
description of manufacturing process and controls, impuritie
specifications, analytical procedures and its verification, batc
analysis and justification of specification, reference standar
container closure system and stability studies of drug substanc
and drug product is submitted.
nomenclature, structure, general properties, solubility, physic
form, manufacturers, description of manufacturing process an
controls, impurities, residual solvents, specifications, analytic
procedures and its complete validation studies, batch analys
and justification of specification, details of reference standard
• Real time: 30°C ± 2°C / 65% ± 5%RH for 36 months
• Accelerated: 40°C ± 2°C / 75% ± 5%RH for 12 months
Batches: (130701, 130702, 130703)
Metfromin:
Batches: (A-72611405016, A-72611405017, A-72611405018)

Module-III (Drug Product): The firm has submitted detail of manufacturers, description o
manufacturing process and controls, impurities, specification
analytical procedure and its validation studies, batch analysis an
justification of specification, reference standard, contain
closure system and stability studies of drug product.
Pharmaceutical equivalence and Product: Diampa-M 12.5/850mg tablet
comparative dissolution profile Mfg date: 06/2021
Batch #: 004FF1
Mfg by: M/s Getz Pharma
Pharmaceutical equivalence and CDP studies have bee
performed against the above described product.
Analytical method Method validation / verification studies have submitte
validation/verification of product including, accuracy/recovery, precision, specificity, , syste
suitability etc for drug substance and drug product.
M/s Jiangsu Yongan Pharmaceutical Co., Limited, No. 18, 237 provincial roa
economic development zone, Huaian Jiangsu, China.
Metformin HCl:
M/s Shouguang Fukang Pharmaceutical co. ltd., North-east of Dongwaihua
road, Dongchend Industrial area, China.
API Lot No. Empgliflozn (5920)
Metformin (6415)
Description of Pack
Alu-Alu blister packed in unit carton
Batch No. 20PD-3330-02-T 20PD-3330-03-T 20PD-3330-04-T
No. of Batches 03
certificate of API manufacturer Copy of GMP certificate valid till 14/01/2024 issued by Huai’a
issued by concerned regulatory Pharmaceutical Industry association, China.
authority of country of origin. Copy of Drug Manufacturing License no. Su 20160324 issued b
Jiangsu Drug Administration (Huai'an Inspection Branch) val
till 06-12-2025.
Metformin HCl;

Copy of GMP certificate No. SD20190888 valid till 12/03/202
issued by CFDA.
3. Documents for the procurement of Empagliflozin:

API with approval from DRAP (in Copy of attested invoice number ZY19100801G/W date
case of import). 18/10/2019 cleared on 22/10/2019 vide dy. No. 11623.
Metformin HCl;
Copy of attested invoice number 419FK08Z092-2 date
10/10/2019 dy. No. 11552 dated 21/10/2019.

data sheets etc.
No.
1 Please provide analytical method verification Analytical method verification studies
studies performed by drug product for empagliflozin is submitted.
manufacturer for empaglflozin drug
substance.
2 Provide GMP certificate / drug manufacturer Empagliflozin:
license issued by relevant authority for Copy of GMP certificate valid till
empagliflozin drug substance. 14/01/2024 issued by Huai’an
Pharmaceutical Industry
association, China.
Copy of Drug Manufacturing License
no. Su 20160324 issued by Jiangsu
Drug Administration (Huai'an
Inspection Branch) valid till 06-12-
2025.
3 Provide Documents for the procurement of Empagliflozin:
API with approval from DRAP (in case of Copy of attested invoice number
import) for Empagliflozin drug substance. ZY19100801G/W dated 18/10/2019
cleared on 22/10/2019 vide dy. No.
11623
4 Titration method is adopted for analysis of The firm has submitted that they had
Metformin HCl while HPLC method has been used the method available in USP at
described for the estimation of Metformin in the time of development of the applied
latest edition of USP, please clarify. product. Now the firm has submitted
Moreover, analytical method verification revised method for assay estimation of
studies are required for Metformin drug Metformin according to latest edition

substance according to latest USP monograph of USP and performed the verification
performed by drug product manufacturer. studies.
5 Provide results of pharmaceutical Product: Diampa-M 12.5/850mg tablet
equivalence studies against the reference / Mfg date: 06/2021
innovator’s product by performing all the Batch #: 004FF1
quality tests along with the results of Mfg by: M/s Getz Pharma
comparative dissolution profile against Pharmaceutical equivalence and CDP
reference / innovator’s product. Moreover, studies have been performed against
provide batch number, expiry and date of the above described product.
manufacturing of the innovator’s / reference
product.
6 Provide detailed analytical method for the Analytical method for the applied
drug product along with analytical method product and the validation studies
validation studies. including specificity, linearity/range,
robustness, precision, accuracy etc
have been submitted.
7 Justify the dissolution parameters since the The firm has referred to Empagliflozin
selected RPM is 75 while as per USFDA tablet’s literature review where the
dissolution data base, the RPM should be 50. speed 75rpm has been selected while
as per the assessment report of
Synjardy tablet the speed is 50rpm.
Decision: Approved.
• Manufacturer will place first three production batches on long term stability studies throughou
proposed shelf life and on accelerated studies for six months as per the commitment submitted
the registration application.
• Manufacturer will perform process validation of first three batches as per the commitmen
• Firm will submit analytical method verifications studies for Metformin HCl drug substance as pe
latest edition of USP (including specificity, accuracy and method precision) before the issuance
registration letter along with the submission of Rs. 7,500/- as pre-registration variation fee as p
• Manufacturer will revise the dissolution specifications for the applied product as per th
innovator’s product (i.e. paddle speed 50rpm) along with the submission of dissolution testing o
commercial batch.
9. Name, address of Applicant / M/s Sami Pharmaceuticals, F-95, Off Hub river Road, S.I.T.E
Marketing Authorization Holder Karachi.
Name, address of Manufacturing site. M/s Sami Pharmaceuticals, F-95, Off Hub river Road, S.I.T.E
Karachi.
☐ Importer
Status of application ☒ New Drug Product (NDP)
☐ Generic Drug Product (GDP)
The proposed proprietary name / Bemdo 180mg tablet
brand name
Active Pharmaceutical ingredient Bempedoic Acid……180mg
(API) per unit
Pharmacotherapeutic Group of (API) Cholesterol lowering agent
specifications
Proposed Pack size 7’s, 10’s, 14’s, 20’s, 28’s 30’s
The status in reference regulatory Nexletol film coated tablet 180 mg, USFDA Approved.
authorities Nilemdo 180mg film ocated tablet, MHRA Approved.
Nilemdo 180mg film coated tablet, Austria Approved
Nilemdo 180mg film ocated tablet, SPAIN Approved
For generic drugs (me-too status) N/A
GMP status of the Finished product Inspection date: 26-03-2020 & 13-04-2020
manufacturer Based on the areas inspected, people met, processes observe
and intention of the firm for continuous improvement at th
time of inspection it is concluded that the firm is operating at
Good level of GMP compliance.
Section approval Tablet Section (General)
Name and address of API M/s Metrochem API private Limited, Unit IV pot no. 34B, 40
manufacturer. & 60B, J.N. Pharma city, Thanam village Parwada Manda
Visakhapatnam District, Andhra Pradesh, India.
Module-II (Quality Overall Firm has submitted QOS as per WHO QOS-PD templat
Summary) Summarized information related to nomenclature, structur
general properties, solubilities, physical form, manufacturer
description of manufacturing process and controls, impuritie
specifications, analytical procedures and its verification, batc
analysis and justification of specification, reference standar
nomenclature, structure, general properties, solubility, physic
form, manufacturers, description of manufacturing process an
controls, impurities, residual solvents, specification
analytical procedures and its complete validation studies, batc
analysis and justification of specification, details of referenc
standards, container closure system and stability studies o
drug substance.
Stability studies • Real time: 30°C ± 2°C / 65% ± 5%RH for 6 months
Batches: (HAN-P/21003, HAN-P/21004, HAN-P/21005)
Module-III (Drug Product): The firm has submitted detail of manufacturers, description o
manufacturing process and controls, impurities, specification
analytical procedure and its validation studies, batch analys
and justification of specification, reference standard, contain
Pharmaceutical equivalence and The firm has submitted pharmaceutical equivalence studie
comparative dissolution profile against the innovator’s product Nexletol Tablet 180mg (batc
number 1708634) by performing quality tests.
Comparative dissolution profile against the innovator
product (Nexletol 180 mg Tablet) in all the three med
including Acetate Buffer (4.5pH), Phosphat eBuffer (6.8ph
and 0.1N HCl (1.2pH). F2 values are within the acceptab
range for 0.1N HCl and Acetate buffer whereas for Phospha
Buffer more than 85% drug is released in 15 minutes.
Analytical method Method validation studies have submitted including linearit
validation/verification of product range, accuracy/recovery, precision, specificity, LOD/LOQ
Robustness, Solution stability, system suitability
Manufacturer of API M/s Metrochem API private Limited, Unit IV pot no. 34B, 40B
60B, J.N. Pharma city, Thanam village Parwada Manda
Visakhapatnam District, Andhra Pradesh, India.
API Lot No. PD/BMP-P/20010
Description of Pack
Alu-PVC blister pakced in unit carton
Batch No. Lab-01 Lab-02 Lab-03
No. of Batches 03
1. Reference of previous approval of Not provided by the firm
applications with stability study data
of the firm (if any)
2. Approval of API/ DML/GMP Copy of GMP certificate no. L.Dis.No: E
certificate of API manufacturer issued 152042/DD/DCA/VSP/2021 dated 29/10/2021 issued by dru
by concerned regulatory authority of control Administration.
country of origin.
3. Documents for the procurement of The firm has submitted copies of packing list, form 3 and for
API with approval from DRAP (in 7.
case of import). Copy of Invoice number DE/20/0149 dated 19/01/2021 cleare
on 26/01/2021 vide dy. No. 0306/2021 is submitted.
sheets etc.

5. Compliance Record of HPLC software Submitted
21CFR & audit trail reports on product
testing
accelerated)
Indications:
Bempedoic Acid is an adenosine triphosphate-citrate lyase (ACL) inhibitor indicated as an adjunct to diet an
maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolem
or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.
No.
1 Provide detailed method of analysis for Submitted.
drug substance along with the
specifications.
2 Tests for reproducibility parameter The firm has submitted revised analytical
(inter-day precision) of analytical method validation report including day
method verification studies have not variation analyst variation and equipment
been performed, please clarify. variation.
3 Provide attested copy of invoice for Copy of Invoice number DE/20/0149 dated
procurement of drug substance. 19/01/2021 cleared on 26/01/2021 vide dy.
No. 0306/2021 is submitted.
4 Provide complete batch manufacturing Submitted.
record.
5 The limit for disintegration time We set the disintegration specs according to
included in finished product USP general monograph which specifies
specifications is 30 minutes while NMT 30mins for film coated tablet. Our
dissolution specifications include product is fast dissolving with a dissolution
80%(Q) of labelled amount of drug at specs of NLT 80% in 20 minutes and
20 minutes. Please clarify or otherwise disintegration time of our product is found
revise the specifications for within 10 minutes which correlates with
disintegration time. dissolution. We have revised the
specifications for DT from NMT 30mins to
NMT 15minuts.
Decision: Approved.
• Firm will submit fee of Rs. 7,500/- for revision of specifications as per notification No.F.7-11/202
10. Name, address of Applicant / Marketing M/s Genix Pharma (pvt) Ltd. 44, 45-B, Korangi Creek
Authorization Holder Road, Karachi.
Name, address of Manufacturing site. M/s Genix Pharma (pvt) Ltd. 44, 45-B, Korangi Creek
Road, Karachi.
☐ Importer
Intended use of pharmaceutical product ☐ Domestic sale
☐ Export sale
The proposed proprietary name / brand name Rebamipide 100mg tablet
Strength / concentration of drug of Active Each film coated tablet contains:
Pharmaceutical ingredient (API) per unit Rebamipide……100mg
Pharmacotherapeutic Group of (API) Anti-gastritis
Reference to Finished product specifications JP
Proposed Pack size 7’s, 14’s, 28’s, 30’s, 60’s
The status in reference regulatory authorities Mucosta film coated tablet 100mg
For generic drugs (me-too status) Mucosta 100mg tablet by Otsuka, Reg. No. 078129
GMP status of the Finished product Copy of GMP certificate no. 46/2021-DRAP(K) issue
manufacturer on the basis of inspection conducted on 15/06/2021.
Section approval Tablet general section (Revised)
Name and address of API manufacturer. M/s Jiangxi Synergy Pharmaceutical Co.,Ltd., Jiang
Fengxin Industrial Park, Jiangxi Province, China.
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO QOS-PD templat
Summarized information related to nomenclatur
structure, general properties, solubilities, physical form
manufacturers, description of manufacturing process an
controls, impurities, specifications, analytical procedure
and its verification, batch analysis and justification o
specification, reference standard, container closu
system and stability studies of drug substance and dru
Module III (Drug Substance) Firm has submitted detailed drug substance data relate
to nomenclature, structure, general properties, solubilit
physical form, manufacturers, description o
manufacturing process and controls, impurities, residu
solvents, specifications, analytical procedures and i
complete validation studies, batch analysis an
justification of specification, details of referenc
standards, container closure system and stability studi
of drug substance.
Stability studies • Real time: 30°C ± 2°C / 65% ± 5%RH for 36 month
• Accelerated: 40°C ± 2°C / 75% ± 5%RH for
months
Batches: (20100704, 20100705, 20100706)
Module-III (Drug Product): The firm has submitted detail of manufacturer
description of manufacturing process and control
impurities, specifications, analytical procedure and i
validation studies, batch analysis and justification o
specification, reference standard, container closu
Pharmaceutical equivalence and comparative Pharmaceutical equivalence studied have bee
dissolution profile performed against the innovator’s product that
Mucosta 100mg Tablet (Batch number MC19607
imported by M/s Otsuka Pakistan Ltd, by performin
quality tests.
Comparative dissolution profile is submitted again
Mucosta 100mg tablet in all the 03 media that is 0.1
HCl, Acetate Buffer and Phosphate Buffer.
Analytical method validation/verification of Method validation / verification studies have submitte
product including accuracy/recovery, precision, specificity e
for drug product and drug substance.
Manufacturer of API M/s Jiangxi Synergy Pharmaceutical Co.,Ltd., Jiangxi Fengx
Industrial Park, Jiangxi Province, China.
API Lot No. 05-20200706C
Description of Pack
Alu-Alu blister
Batch No. 21SB(A)-
21SB(A)-023-02 21SB(A)-023-03
023-01
No. of Batches 03
1. Reference of previous approval of The firm has not submitted any response.
applications with stability study data of the
firm (if any)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate no. 2022001 valid t
API manufacturer issued by concerned 19/01/2027 issued on 20/01/2022 issued by Jiangxi A
regulatory authority of country of origin. Engineering technology research Centre, China
submitted.
Copy of GMP certificate No. 2020002 issued by CFD
3. Documents for the procurement of API with
approval from DRAP (in case of import). The firm has submitted copy of attested invoice numb
JXSG201131 dated 06-11-2020cleared on 02/12/2020.

4. Data of stability batches will be supported by Submitted
attested respective documents like
chromatograms, Raw data sheets, COA,
summary data sheets etc.
5. Compliance Record of HPLC software 21CFR Submitted
& audit trail reports on product testing
6. Record of Digital data logger for temperature Submitted
and humidity monitoring of stability chambers
No.
1 Justify the limit (i.e NMT As per JP, to calculate the %age of m-chloroisomer as per given
0.15%) selected for Rebamipide acceptance criteria 1.e 3/8 times the area of standard, first
m-chloro isomer since J.P does calculate the concentration of standard that is 0.0016mg/mL
not describe the limit in terms of and then sample that is 0.4mg/mL then finally calculate the
percentage for the isomer as well percentage of m-chloroisomer (0.15%).
as for the other related substance Same procedure has been adopted for calculation of other
in the specifications of drug impurities.
substance.
2 Real time stability data for of The firm has submitted real time stability data of drug substance
drug substance (batch number for batch number 20100706.
20100706) is not submitted,
provide the required data.
3 Provide results of comparative The firm has provided comparative dissolution profile against
dissolution profile along with the Mucosta Tablet 100mg by M/s Otsuka Pakistan, batch number
calculations of F2 and F1 MC196077 in all the 3 media. F2 values are in acceptable range.
factors.
4 Submitted stability data is till 3rd The firm submitted stability data till 6 month time point.
month time point, provide
stability study data till 6 months.
5 Provide Record of digital data Submitted.
logger for temperature and
humidity monitoring of stability
chambers (real time and
accelerated) for the applied
product
Decision: Approved.
Case No. II: Export facilitation

Assistant director PR-I/EFD vide letter No.F.1-6/2019-PR-I (EFD dated 06-10-2022 has informed that
DRAP Authority in its 133rd meeting held on 13th April 2022, decided to grant registration on priority
basis to the pharmaceutical i.e one molecule for each 100,000 USD worth of export of medicines (to a
maximum of 15 such molecules) during a fiscal year. In compliance to the aforementioned decision of
the authority, the following firm have achieved the benchmark of more than 100,000 USD during the
fiscal Year 2020-2021 and submitted their applications for priority consideration in lieu of export
facilitation for Registration Board please.,
11. Name, address of Applicant / M/s Novamed Pharmaceuticals (pvt) Ltd. 28-km
Marketing Authorization Holder Ferozepur rod, Lahore.
Name, address of Manufacturing M/s Novamed Pharmaceuticals (pvt) Ltd. 28-km
site. Ferozepur rod, Lahore.
☐ Importer
Empozin-M 12.5mg+500mg tablet
brand name
Strength / concentration of drug of Each film coated tablet Contains:
Active Pharmaceutical ingredient Empagliflozin……..12.5mg
(API) per unit Metformin HCl……….500mg
drug
Antidiabetic
(API)
Reference to Finished product In-house specs
specifications
The status in reference regulatory Synjardy tablet (5/500, 5/1000, 12.5/500, 12.5/1000),
authorities USFDA Approved.
For generic drugs (me-too status) Diampa-M 12.5/500 by Getz Pharma
GMP status of the Finished product Copy of GMP certificate No. 68/2021-DRAP(FID-
manufacturer 385689549774-222) issued on the basis of inspection
Section approval Tablet general section (revised)
Name and address of API Empagliflozin: M/s Jiangsu Yongan Pharamceutical
manufacturer. Co., Ltd., 18, 237 provincial road, economic
development zone, Huai’an Jiangsu, China.
Metformin HCl: Aarti Drug limited (unit II) plot no.
211 & 213, road – 2, GIDC at & post: Sarigam 396
155 Dist: Valsad Gujarat India.
Metformin).
months
months
Batches: (130701, 130702, 130703)
Metfromin:
months
months
Batches: (MEF/1510145, MEF/1510146,
MEF/1510147)
Pharmaceutical equivalence and The firm has submitted comparative dissolution
comparative dissolution profile profile in all the 03 media that is 0.1N HCl, Phosphate
buffer and Acetate buffer against Synjardy
12.5/500mg, mfg by Boehringer ingelheim pharma
GmbH & Co. KG Binger Strasse Germany, Batch
number C98959.
The firm has submitted CDP studies against the
innovator’s product that is Synjardy (B: C98959) in
all the three media that is 0.1N HCl, Acetate Buffer
and Phosphate Buffer.
Manufacturer of API Empagliflozin: M/s Jiangsu Yongan Pharamceutical Co., Ltd., 18,
237 provincial road, economic development zone, Huai’an Jiangsu,
China.

Metformin HCl: M/s Aarti Drug limited (unit II) plot no. 211 & 213,
road – 2, GIDC at & post: Sarigam 396 155 Dist: Valsad Gujarat
India.
API Lot No. Empgliflozin: 4500-202003001
Metformin HCl:MEF/11041012
Description of Pack
Batch No. RD/PR21-100/T1/S1 RD/PR21-100/T1/S2 RD/PR21-100/T1/S3
No. of Batches 03
2. Approval of API/ DML/GMP Empagliflozin: Copy of GMP certificate valid till
certificate of API manufacturer 14/01/2024 issued by Huai’an Pharmaceutical
issued by concerned regulatory industry Association.
authority of country of origin. Copy of DML number Su20160324 issued by Jiangsu
Medical Products Administration on 07/12/2020 valid
till 06/12/2025 for Empagliflozin drug substance
manufacturer.
Metformin HCl: copy of GMP certificate no.
20031933 valid till 19/03/2023 issued by food and
drugs control administration, Gujarat.
API with approval from DRAP (in invoice No. ZY20052001G/W dated 20th May, 2020
case of import). vide diary number 7093/2020-DRAP dated
09/06/2020.
Metformin HCl: Copy of attested invoice cleared on
15/02/2021 dy. No. 2473/24-DRAP is submitted.
data sheets etc.
No.
1 Provide certificate of analysis of Copies of COAs from finished product and
Empagliflozin & Metformin HCl for drug substance manufacturer is submitted
those batches which were used for for batch number 4500202003001
product development from finished (Empagliflozin) and for batch number
product manufacturer and drug MEF/11041012 (Metformin HCl) are
substance manufacturer. submitted.
2 Submitted GMP certificate for Copy of DML number Su20160324 issued
Empagiflozin is from Huai’an industry by Jiangsu Medical Products Administration
association, provide GMP certificate on 07/12/2020 valid till 06/12/2025 for
issued by relevant authority. Empagliflozin drug substance manfuatcurer.
3 Provide documents (i.e invoices) Copy of attested invoice cleared on
confirming import of Metformin HCl 15/02/2021 dy. No. 2473/24-DRAP is
drug substance. submitted.
4 Provide analytical method verifiction The firm has submitted analytical mehto
studies for drug substances dverification / validations studies for
(Empagliflozin & Metformin HCl) Metformin HCl and Empagliflozin drug
performed by drug product substances performed by drug product
manufacturer. manufacturer.
5 Provide results of Comparative The firm has submitted CDP studies against
dissolution profile performed against the the innovator’s product that is Synjardy (B:
innovator’s product for Empozin-M C98959) in all the three media that is 0.1N
12.5mg/500mg tablet. HCl, Acetate Buffer and Phosphate Buffer.
6 Clarification is required since as per The firm has submitted that they will revised
available literature of the reference the dissolution specifications as per the
product, Q value should be achieved in innovator’s product.
20 minutes while you have performed
the said studies at 30 minutes in all the
five strengths (12.5/1000, 5/500,
5/1000, 5/850, 12.5/500) of the applied
product.
7 The submitted stability data is till 3rd The firm has submitted 6th month time point
month time point, please submit the data for all the three batches for accelerated
stability data till 6 months. and real time stability studies.
Decision: Approved with innovator’s specifications. The Board decided that the manufacturer
will submit fee of Rs. 7,500/- for revision of specifications as per notification No.F.7-11/2021-
• Manufacturer will submit revised dissolution specifications as per innovator’s product
(i.e. sampling time at 20 minutes) along with the performance of testing on commercial

batches.
12. Name, address of Applicant / M/s Novamed Pharmaceuticals (pvt) Ltd. 28-km
Marketing Authorization Holder Ferozepur rod, Lahore.
Name, address of Manufacturing M/s Novamed Pharmaceuticals (pvt) Ltd. 28-km
site. Ferozepur rod, Lahore.
☐ Importer
Empozin-M 5mg+850mg tablet
brand name
Strength / concentration of drug of Each film coated tablet Contains:
Active Pharmaceutical ingredient Empagliflozin……..5mg
(API) per unit Metformin HCl……….850mg
drug
Antidiabetic
(API)
Reference to Finished product In-house specs
specifications
Synjardy tablet (5/8508) EMA Approved.
authorities
For generic drugs (me-too status) Diampa-M 12.5/500 by Getz Pharma
GMP status of the Finished product Copy of GMP certificate No. 68/2021-DRAP(FID-
manufacturer 385689549774-222) issued on the basis of inspection
Section approval Tablet general section (revised)
Name and address of API Empagliflozin: M/s Jiangsu Yongan Pharamceutical
manufacturer. Co., Ltd., 18, 237 provincial road, economic
development zone, Huai’an Jiangsu, China.
Metformin HCl: Aarti Drug limited (unit II) plot no.
211 & 213, road – 2, GIDC at & post: Sarigam 396
155 Dist: Valsad Gujarat India.

Metformin).
months
months
Batches: (130701, 130702, 130703)
Metfromin:
months
months
Batches: (MEF/1510145, MEF/1510146,
MEF/1510147)
Pharmaceutical equivalence and The firm has submitted comparative dissolution
comparative dissolution profile profile in all the 03 media that is 0.1N HCl, Phosphate
buffer and Acetate buffer against Synjardy 5/850mg,
mfg by Boehringer ingelheim pharma GmbH & Co.
KG Binger Strasse Germany, Batch number 902007.
The firm has submitted CDP studies against the
innovator’s product that is Synjardy (B: 902007) in
all the three media that is 0.1N HCl, Acetate Buffer
and Phosphate Buffer.
China.
Metformin HCl: M/s Aarti Drug limited (unit II) plot no. 211 & 213,
India.
Metformin HCl:MEF/11041012
Description of Pack
No. of Batches 03
2. Approval of API/ DML/GMP Empagliflozin: Copy of GMP certificate valid till
certificate of API manufacturer 14/01/2024 issued by Huai’an Pharmaceutical
issued by concerned regulatory industry Association.
authority of country of origin. Copy of DML number Su20160324 issued by Jiangsu
Medical Products Administration on 07/12/2020 valid
till 06/12/2025 for Empagliflozin drug substance
manufacturer.
20031933 valid till 19/03/2023 issued by food and
drugs control administration, Gujarat.
API with approval from DRAP (in invoice No. ZY20052001G/W dated 20th May, 2020
case of import). vide diary number 7093/2020-DRAP dated
09/06/2020.
Metformin HCl: Copy of attested invoice cleared on
15/02/2021 dy. No. 2473/24-DRAP is submitted.
data sheets etc.
No.
1 Provide certificate of analysis of Copies of COAs from finished product and
Empagliflozin & Metformin HCl for drug substance manufacturer is submitted
those batches which were used for for batch number 4500202003001
product development from finished (Empagliflozin) and for batch number
product manufacturer and drug MEF/11041012 (Metformin HCl) are
substance manufacturer. submitted.
2 Submitted GMP certificate for Copy of DML number Su20160324 issued
Empagiflozin is from Huai’an industry by Jiangsu Medical Products Administration
association, provide GMP certificate on 07/12/2020 valid till 06/12/2025 for
issued by relevant authority. Empagliflozin drug substance manfuatcurer.
3 Provide documents (i.e invoices) Copy of attested invoice cleared on
confirming import of Metformin HCl 15/02/2021 dy. No. 2473/24-DRAP is
drug substance. submitted.
4 Provide analytical method verifiction The firm has submitted analytical method
studies for drug substances verification / validations studies for
(Empagliflozin & Metformin HCl) Metformin HCl and Empagliflozin drug
performed by drug product substances performed by drug product
5 Clarification is required since as per The firm has submitted that they will revised
available literature of the reference the dissolution specifications as per the
product, Q value should be achieved in innovator’s product.
20 minutes while you have performed
the said studies at 30 minutes in all the
five strengths (12.5/1000, 5/500,
5/1000, 5/850, 12.5/500) of the applied
product.
6 The submitted stability data is till 3rd The firm has submitted 6th month time point
month time point, please submit the data for all the three batches for accelerated
stability data till 6 months. and real time stability studies.
Decision: Approved with innovator’s specifications. The Board decided that the manufacturer
will submit fee of Rs.7,500/- for revision of specifications as per notification No.F.7-11/2021-
batches.
A: Registration Applications for which stability data is required submitted on Form 5 / Form
5D

I: M/s Novamed Pharmaceuticals (pvt) ltd.:
Sr. Name & Address Brand Name Type of Form, International
No. of Manufacturer / (Proprietary Name + Dosage Initial Diary & Availability
Applicant Form + Strength), Date, Fee
Composition, (including GMP Inspection
Pharmacological Group, differential fee), Report Date &
Finished Product Demanded Price / Remarks
Specification Pack size
13. M/s Novamed Empozin-M 12.5mg+1000mg Form 5-D Synjardy tablet
Pharmaceuticals tablet Dy No. 2908 (5/500, 5/1000,
(pvt) Ltd. 28-km Each film coated tablet 12-04-2017 12.5/500,
Ferozepur rod, Contains: PKR.50,000/- 12.5/1000),
Lahore. Empagliflozin……..12.5mg (copy of fee USFDA
Metformin HCl……1000mg challan) Approved.
Antidiabetic 15-10-2018
In-house specs 14’s, 28’s Diampa-M by Get
As per SRO Pharma
14. M/s Novamed Empozin-M 5mg+500mg tablet Form 5-D Copy of GMP
Pharmaceuticals Each film coated tablet Dy No. 2906 certificate No.
(pvt) Ltd. 28-km Contains: 12-04-2017 68/2021-
Ferozepur rod, Empagliflozin……..5mg PKR.50,000/- DRAP(FID-
Lahore. Metformin HCl……500mg (copy of fee 385689549774-
Antidiabetic challan) 222) issued on the
In-house specs 15-10-2018 basis of
14’s, 28’s inspection
As per SRO conducted on
06/08/2021.
15. M/s Novamed Empozin-M 5mg+1000mg Form 5-D Tablet general
Pharmaceuticals tablet Dy No. 2907 section (revised)
(pvt) Ltd. 28-km Each film coated tablet 12-04-2017
Ferozepur rod, Contains: PKR.50,000/-
Lahore. Empagliflozin……..5mg (copy of fee
Metformin HCl……1000mg challan)
Antidiabetic 15-10-2018
In-house specs 14’s, 28’s
As per SRO
Alternate brand names: Exempa-M, Zampa-M, Gempaz-M
Stability data is submitted on 19/07/2021.
* As per available literature of the reference product, Q value should be achieved in 20 minutes while
the firm has performed the said studies at 30 minutes in all the five strengths (12.5/1000, 5/500,
5/1000, 5/850, 12.5/500) of the applied product.
China.
Metformin HCl: Aarti Drug limited (unit II) plot no. 211 & 213,
India.
Metformin HCl: MEF/19123234
Description of Pack Alu-Alu foil packed in unit carton
Stability Storage Condition Accelerated: 40°C ± 2°C / 75% ± 5%RH
Real Time: 30°C ± 2°C / 65% ± 5%RH
Time Period Accelerated: 6 Months
Real Time: 6 Months
Frequency Real Time: 0,3 & 6 (months)
Accelerated: 0, 3, 6 (months)
Empozin-M 12.5mg+1000mg tablet
No. of Batches 03
No. of Batches 03
No. of Batches 03
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
1. Reference of previous approval of applications Firm has referred to onsite inspection report of
with stability study data of the firm their product Dasvir Tablets (60mg & 90mg)
which was conducted on 22/01/2018 for
verification stability data and was presented in
278th meeting of Registration Board. The Board
approved the cases.
2. Certificate of Analysis of API from both API The firm has certificate of analysis for relevant
Manufacturer and Finished Product batch used for the product development from
manufacturer. drug substance manufacturer for Empagliflozin
along with the COA of impurity standards for
impurity A and impurity B.
3. Method used for analysis of API from both Firm has submitted copy of method used for
API Manufacturer and Finished Product analysis of API from both API Manufacturer
manufacturer and Finished Product manufacturer

4. Stability study data of API from API Empagliflozin:
manufacturer • Real time: 30°C ± 2°C / 65% ± 5%RH for
36 months
12 months
Batches: (130701, 130702, 130703)
Metfromin:
• Real time: 30°C ± 2°C / 65% ± 5%RH for
60 months
6 months
Batches: (MEF/1510145, MEF/1510146,
MEF/1510147)
5. Approval of API/ DML/GMP certificate of Empagliflozin: Copy of GMP certificate valid
API manufacturer issued by concerned till 14/01/2024 issued by Huai’an
regulatory Pharmaceutical industry Association.
authority of country of origin. Copy of DML number Su20160324 issued by
Jiangsu Medical Products Administration on
07/12/2020 valid till 06/12/2025 for
Empagliflozin drug substance manufacturer.
20031933 valid till 19/03/2023 issued by food
and drugs control administration, Gujarat.
6. Documents for the procurement of API with Empagliflozin: Firm has submitted copy of
approval from DRAP (in case of import). attested invoice No. ZY20052001G/W dated
20th May, 2020 vide diary number 7093/2020-
DRAP dated 09/06/2020.
Metformin HCl: Copy of attested invoice dated
25/12/2019 cleared vide diary number
436/2020-DRAP dated 08/01/2020.
7. Protocols followed for conduction of stability Firm has submitted protocols followed for
study conduction of stability study
8. Method used for analysis of FPP Firm has provided detailed method for analysis
of finished product (In-House).
9. Drug-excipients compatibility studies (where Firm has used same excipients as that of the
applicable) innovator’s product therefore compatibility
studies are not required
10. Complete batch manufacturing record of three Firm has provided Batch Manufactu ring
stability batches. Record for all the batches of applied products.
11. Record of comparative dissolution data (where The firm has submitted comparative dissolution
applicable) profile in all the 03 media that is 0.1N HCl,
Phosphate buffer and Acetate buffer against :
• Synjardy 12.5/1000mg, mfg by Boehringer
ingelheim pharma GmbH & Co. KG Binger
Strasse Germany, Batch number 003231.
• Synjardy 5/500mg, mfg by Boehringer
Strasse Germany, Batch number C98957.
• Synjardy 5/1000mg, mfg by Boehringer
Strasse Germany, Batch number 004425.

12. Data of 03 batches will be supported by Firm has submitted documents like
attested respective documents like chromatograms, raw data sheets, COA,
chromatograms, Raw data sheets, COA, summary data sheets for the stability studies
13. Compliance Record of HPLC software 21CFR Firm has submitted certificate of compliance
& audit trail reports on product testing. and audit trail reports for HPLC analysis for all
the three batches.
14. Record of Digital data logger for temperature Firm has submitted record of digital data logger
and humidity monitoring of stability for both stability chambers for accelerated as
chambers well as real time stability studies.
Evaluation by PEC:
Sr. Shortcomings communicated Response by the firm

no.
1 Please provide certificate of analysis for The firm has provided COAs for Empagliflozin
Empagliflozin drug substance for the from drug substance and drug product
batch used for product development from manufacturer for batch number 4500-
drug product manufacturer. 202003001.
2 Submitted GMP certificate for Copy of DML number Su20160324 issued by
Empagiflozin is from Huai’an industry Jiangsu Medical Products Administration on
association, provide GMP certificate 07/12/2020 valid till 06/12/2025 for
issued by relevant authority. Empagliflozin drug substance manufacturer.
3 Provide certificate of Analysis of API The firm has provided COAs for Metformin
from both API Manufacturer and from drug substance and drug product
Finished Product Manufacturer for manufacturer for batch number MEF/19123234.
Metformin HCl.
4 Provide documents (i.e invoice) Copy of attested invoice dated 25/12/2019
confirming import of Metformin HCl cleared vide diary number 436/2020-DRAP
drug substance. dated 08/01/2020.
5 As per provided method of analysis from The firm has stated that the drug substance
drug substance manufacturer, titration manufacturer and drug product manufacturer
method has been used for assay have used BP method for analysis of Metformin
estimation while according to latest HCl where the method of assay analysis is
edition of USP, HPLC method should be titration.
used for assay testing, please clarify.
Decision: Registration Board approved the registration applications of Empozin-M
12.5mg+1000mg tablet, Empozin-M 5mg+500mg tablet, Empozin-M 5mg+1000mg tablet with
innovator’s specifications. The Board further decided that the manufacturer will submit fee of
Rs. 7,500/- for revision of specifications for strength as per notification No.F.7-11/2021-
letter.
batches.
III: M/s Genix Pharma Pvt. Ltd.

16. M/s Genix Pharma Vonraz 10mg tablet Form 5D Takecab tablet
(pvt) Ltd. 44, 45-B, Each film coated tablet Dy. No. 11980 (10mg & 20mg),
Korangi Creek contains: dated 06/03/2019 PMDA Japan
Road, Karachi. Vonoprazan as Rs. 50,000/- Approved.
fumarate…..10mg dated 06/03/2019
Potassium-competitive acid 10’s, 20’s, 30’s Copy of GMP
blocker As per SRO certificate no.
In House 46/2021-
DRAP(K) issued
17. M/s Genix Pharma Vonraz 20mg tablet Form 5D on the basis of
(pvt) Ltd. 44, 45-B, Each film coated tablet Dy. No. 11981 inspection
Korangi Creek contains: dated 06/03/2019 conducted on
Road, Karachi. Vonoprazan as Rs. 50,000/- 15/06/2021.
fumarate…..20mg dated 06/03/2019
Potassium-competitive acid 10’s, 20’s, 30’s
blocker As per SRO
In House
The firm submitted the stability data on 21/02/2022.
The firm has submitted analytical method validation studeis for drug product including accuracy,
linearity, specificity, robustness, precision etc.
Manufacturer of API M/s Jiangxi Synergy Pharmaceutical Co., Ltd.,, Jiangxi Fengxin
Industrial Park 330700 Fengxin County, Jiangxi Province, China.
API lot number 20201201BD
Description of Pack Alu-Alu blister packed in secondary unit carton
Real Time: 30°C ± 2°C / 65% ± 5%RH
Real Time: 6 Months
Vonraz 10mg tablet
Batch No. 21SB(A)-155-01 21SB(A)-157-03 21SB(A)-156-02

No. of Batches 03
Vonraz 20mg tablet
Batch No. 21SB(A)-160-03 21SB(A)-159-02 21SB(A)-158-01
No. of Batches 03
1. Reference of previous approval of applications The firm has referred to the decision of 281st
with stability study data of the firm meeting of Registration Board whereby the
product Wymly 25mg (Tenofovir) was
approved on the basis of PSI report. Following
were endorsed in the report.
• 21 CFR complaint system
2. Certificate of Analysis of API from both API Submitted
Manufacturer and Finished Product
manufacturer.
4. Stability study data of API from API • Real time: 30°C ± 2°C / 65% ± 5%RH for
manufacturer 24` months
12 months
Batches: (20190801BD, 20190803BD,
20190801BD)
5. Approval of API/ DML/GMP certificate of Copy of GMP certificate no. 2022001 valid till
API manufacturer issued by concerned 19/01/2027 issued on 20/01/2022 issued by
regulatory Jiangxi API Engineering technology research
authority of country of origin. centre, China sis submitted.
6. Documents for the procurement of API with Copy of invoice number JXSG210156 dated
approval from DRAP (in case of import). 28/01/2021 cleared on 17/02/2021.
10. Complete batch manufacturing record of three Firm has provided Batch Manufacturing Record
stability batches. for all the batches of applied products.
Phosphate buffer and Acetate buffer against

Vonozan 10mg (Bbatch number: 005FF8) &
20mg Tablet mfg by M/s Getz Pharma.
the three batches .
Evaluation by PEC:

no.
1 Provide copy of valid GMP certificate of Copy of GMP certificate no. 2022001 valid till
drug substance manufacturer issued by 19/01/2027 issued on 20/01/2022 issued by
relevant authority. Jiangxi API Engineering technology research
centre, China sis submitted.
Copy of GMP certificate No. 2020002 issued by
CFDA valid till 11/03/2025.
2 Please provide COA of relevant batch of Submitted.
drug substance used for product
development from drug product
manufacturer.
3 Provide chromatographic conditions The firm has submitted complete method of
along with the complete method of analysis along with the specification for the
analysis used for drug substance from applied product.
drug substance manufacturer.
4 Comparative dissolution profile is No response is submitted by the firm.
established against the comparator’s
product while the said study is required
against Innovator’s / reference product,
please provide the required data.
5 Latest inspection report / GMP certificate Copy of GMP certificate number 46/2021-
of drug product manufacturer is required. DRAP(K) issued on the basis of inspection
6 Provide documents confirming import of Copy of invoice number JXSG210156 dated
API with the approval from DRAP. 28/01/2021 cleared on 17/02/2021.
7 Provide detail of container closure Alu-Alu blister packed in secondary unit carton
system for the drug product.
8 Please submit stability summary sheet Real time stability study summary sheet for the
for batch number 21SB(A)-159-02 of said batch number along with the
20mg tablet for 3rd month time point of chromatograms is submitted for 3rd month time
real time stability studies along with the point.
chromatograms and raw data sheets.
Decision: Approved with innovator’s specifications. Registration Board decided that the
manufacturer will submit fee of Rs. 7,500/- for revision of specifications as per notification
No.F.7-11/2021-B&A/DRAP dated 07-05-2021.
18. M/s Genix Pharma Ertozin-M 7.5/500 tablet Form 5D USFDA
(pvt) Ltd. 44, 45-B, Each firm cated tablet contains: Dy. No. 33467 Approved.
Korangi Creek Ertugliflozin as L-Pyroglutamic dated 09/10/2019 (2.5/500,
Road, Karachi. acid…….7.5mg Rs. 50,000/- 2.5/1000, 7.5/500,
Metfromin HCL……500mg dated 06/03/2019 7.5/1000)
Innovator’s specifications 60’s, 180’s, 500’s
As per SRO
Copy of GMP
19. M/s Genix Pharma Ertozin-M 2.5/500 tablet Form 5D certificate no.
(pvt) Ltd. 44, 45-B, Each firm cated tablet contains: Dy. No. 334655 46/2021-
Korangi Creek Ertugliflozin as L-Pyroglutamic dated 09/10/2019 DRAP(K) issued
Road, Karachi. acid…….2.5mg Rs. 50,000/- on the basis of
Metfromin HCL……500mg dated 06/03/2019 inspection
Innovator’s specifications 60’s, 180’s, 500’s conducted on
As per SRO 15/06/2021.
Manufacturer of API Errtugliflozin:
M/s Shanghai Pharma Group Changzhou Kony Pharamceutical Co.,
Ltd., Daixi street, Luoyang town, Wujih district, Changzhou,
Jiangsu China.
Metformin:
M/s Abhilash Chemicals & Pharmaceutical Pvt. Ltd. 34/6A,
Nayakkanpatti Village, Madurai North Taluk, Madural-625301,
India.
API lot number Ertugliflozin:
ETG20180901
Metformin:
MET/01/19030435, MET/01/19030550, MET/B/01/19030070
Description of Pack Alu-Alu blister
Real Time: 30°C ± 2°C / 65% ± 5%RH
Real Time: 6 Months
Ertozin-M 7.5/500 tablet
Batch No. 20SB-022-03 20SB-021-02 20SB-020-01
No. of Batches 03
Ertozin-M 2.5/500 tablet
Batch No. 20SB-010-03 20SB-008-01 20SB-0-0
No. of Batches 03
• 21 CFR complaint system
2. Certificate of Analysis of API from both API Submitted
manufacturer.
12 months
Batches: (ETG20161201, ETG2016202,
ETG20170101)
5. Approval of API/ DML/GMP certificate of Ertugliflozin:
API manufacturer issued by concerned Copy of good manufacturing certificate issued
regulatory by Jiangsu Food and Drug Administration,
authority of country of origin. Changzhou Pharmaceutical Profession
Association, China valid till 27/06/2023.
Metformin HCl:
Copy of GMP certificate no. 17777/D1/4/2018
dated 18/02/2019 valid till 31/12/2021 issued by
Food safety and Drug Control Administration,
India.
6. Documents for the procurement of API with Ertugliflozin:
approval from DRAP (in case of import). Copy of invoice cleared on 02/10/2018 dy. No.
2799.
Metformin:

Copy of invoice number GSTE-189/2018-19
cleared on 21/03/2019 dy. No. 3475.
Phosphate buffer and Acetate buffer against the
innovator’s product:
• Seruglumet (2.5/500)mg tablet
• Seruglumet (7.5/500)mg tablet
the three batches .
Evaluation by PEC:
Decision: Approved. Registration Board decided that the manufacturer will submit fee of Rs.
7,500/- for revision of specifications as per notification No.F.7-11/2021-B&A/DRAP dated 07-
05-2021.
letter.
20. M/s Genix Pharma Hypron ER tablet 50mg Form 5D USFDA
(pvt) Ltd. 44, 45-B, (Duplicate Dossier) Approved
Korangi Creek Each Prolonged Release, Film Dy. No. 747 Mibega by Getz
Road, Karachi. Coated Tablet contains: dated 05/05/2016 Pharma, Reg. No.
Mirabegron…….50mg Rs. 1500/- per 089378
Beta-3 adrenergic agonist (used tablet
for treatment of overactive (10’s, 20’s, 30’s) Copy of GMP
bladder-OAB) certificate no.
In-house **The firm has 46/2021-
submitted Rs. DRAP(K) issued
50,000/- fee on on the basis of
24/10/2022 in inspection
wrong head that is conducted on
1440 (Budget & 15/06/2021.
accounts) for
manual fee
adjustment for
registration of
Mirabegron 50mg
tablet. The firm is
unable to provide
old challan.
Manufacturer of API M/s Jiangxi Synergy Pharmaceutical Co., Ltd., Jiangxi Fengxin
Industrial Park, Jiangxi province China
API lot number 20190101V
Description of Pack Alu-Alu blister packed in secondary unit carton
Real Time: 30°C ± 2°C / 65% ± 5%RH
Real Time: 6 Months
Batch No. 20SB-166-01 20SB-167-02 20SB-168-03
No. of Batches 03
• 21 CFR compliant system

2. Certificate of Analysis of API from both API Submitted.
manufacturer.
12 months
Batches: (2015302. 2015303, 2015304)
5. Approval of API/ DML/GMP certificate of Copy of GMP certificate no. 2022001 valid till
API manufacturer issued by concerned 19/01/2027 issued on 20/01/2022 issued by
regulatory Jiangxi API Engineering technology research
authority of country of origin. centre, China sis submitted.
Copy of GMP certificate No. 2020002 issued by
CFDA valid till 11/03/2025.
Copy of Pharmaceutical Production License
vide No. GAN 20160125 dated 27.11.2020
issued by Jiangxi Provincial Medical Products
Administration China valid till 26.11.2025
6. Documents for the procurement of API with Copy of invoice number JXSG200137 dated
approval from DRAP (in case of import). 15/01/2020 cleared on 24/01/2020 vid dy. No.
0336 is submitted.
Phosphate buffer and Acetate buffer against the
innovator’s product Myrbetriq 50mg tablet
(Batch number G1900197). The F2 values are
within the acceptable limits.
the three batches.

Evaluation by PEC:

no.
1 Provide documents for the procurement Copy of invoice number JXSG200137 dated
of API with approval from DRAP. 15/01/2020 cleared on 24/01/2020 vid dy. No.
0336 is submitted.
2 Stability data for batch number 20SB- The firm has submitted 6 month accelerated and
166-01 of finished product is submitted real time stability data of batch numbers 20SB-
while data for 2 more batches is required. 167-02 & 20SB-168-03 for 6 months with the
following details.
Batch size: 1500 tablets
Date of Mfg: 09/2020
Date of initiation of stability: 14/10/2020
3 Provide valid copy of GMP certificate for Copy of GMP certificate no. 2022001 valid till
drug substance manufacturer issued by 19/01/2027 issued on 20/01/2022 issued by
relevant authority. Jiangxi API Engineering technology research
centre, China sis submitted.
4 Provide detail of the innovator’s product The firm has submitted comparative dissolution
against which the comparative profile in all the 03 media that is 0.1N HCl,
dissolution profile is submitted including Phosphate buffer and Acetate buffer against the
batch number, expiry, manufacturing innovator’s product Myrbetriq 50mg tablet
date and approval granting authority. (Batch number G1900197). The F2 values are
within the acceptable limits.
5 As per initially submitted dossier, M/s M/s Jiangxi Synergy Pharmaceutical Co., Ltd.,
Optimus Drugs (P) Limited is AP Jiangxi Fengxin Industrial Park, Jiangxi
manufacturer while as per the province China is the API supplier. The firm has
information submitted with stability already submitted the relevant documents
studies the drug substance manufacturer including invoice, COAs, GMP certificate etc.
is M/s Jiangxi Synergy Pharmaceutical
Co., Ltd., please clarify.
6 Provide stability study data of drug • Real time: 30°C ± 2°C / 65% ± 5%RH for
substance according to the conditions of 24` months
zone IV-A. • Accelerated: 40°C ± 2°C / 75% ± 5%RH for
12 months
Batches: (2015302. 2015303, 2015304)
Decision: Approved with innovator’s specifications. Registration Board further decided that the
No.F.7-11/2021-B&A/DRAP dated 07-05-2021.
B: M/s Wilshire Laboratories (pvt) ltd.

Export facilitation
21. Name and address of M/s Wilshire Laboratories Pvt Ltd.
manufacture / Applicant 124/1, Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore
Brand Name + Dosage Form P-Pride 1mg Tablet
and Strength

Composition Each Film Coated Tablet Contains:
Prucalopride……………….…1mg
Dairy No. date of R &I fee Form-5D Dy.No 9629 dated 01-03-2019 Rs.50,000/- Dated
01-03-2019
Pharmacological Group Other drugs for constipation
Type of form Form 5D
Finished product specifications Manufacturer’s specifications
Pack size and Demand Price 5’s, 7’s, 10’s, 20’s, 30’s, 40’s, 50’s; As per SRO
Approval status of product in MOTEGRITY (1mg, 2mg) film coated tablets USFDA
Reference Regulatory Approved
Authorities
Me-too-status
GMP Status The firm was inspected on 08-08-2019 and
Recommendations/conclusion of inspections was:
Keeping in view the findings of inspection proceedings, areas
checked including location of premises, production facility,
material management, laboratory controls, personnel and
documents reviewed, M/s Wilshire Labs Pvt Ltd Lahore is
considered to be operating at an acceptable level of compliance
with respect to GMP guidelines for pharmaceutical product.
The firm was further advised to submit CAPA report with
respect to the current inspection proceedings.
Remark of the Evaluator XI
• Letter of deficiencies sent on 21-10-2020 and reminder on
27-01-2021 but no reply received yet
• Mention the salt form of Prucalopride in label claim and
adjust its weight in master formulation considering the salt
form along with submission of applicable fee.
• Submission of stability studies data of three batches as per
guidelines approved in 293rd meeting of Registration
Board.
Decision of 307thmeeting: Deferred for the following:
• Mentioning the salt form of Prucalopride in label claim and adjust its weight in master
formulation considering the salt form along with submission of applicable fee.
• Submission of stability study data as per the guidelines approved in 293rd meeting of
Registration Board.
Submission by the firm:
The firm has submitted revised Form 5D with revised label claim with stability data which presented
below.
Moreover, Fee of Rs. 7500/- is submitted vide slip number 7360335285 dated 08/12/2021 for 2mg
tablet and Rs 7500/- vide slip number 25956780 dated 08/12/2021 for 1mg tablet.
22. Name and address of M/s Wilshire Laboratories Pvt Ltd.
manufacture / Applicant 124/1, Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore
Brand Name + Dosage Form P-Pride 2mg Tablet
and Strength
Prucalopride………………….2mg
Dairy No. date of R &I fee Form-5D Dy.No 9630 dated 01-03-2019 Rs.50,000/- Dated
01-03-2019
Pharmacological Group Other drugs for constipation
Pack size and Demand Price 5’s, 7’s, 10’s, 20’s, 30’s, 40’s, 50’s; As per SRO

Approval status of product in MOTEGRITY (1mg, 2mg) film coated tablets USFDA
Reference Regulatory Approved
Authorities
Me-too-status
GMP Status The firm was inspected on 08-08-2019 and
Recommendations/conclusion of inspections was:
Keeping in view the findings of inspection proceedings, areas
checked including location of premises, production facility,
material management, laboratory controls, personnel and
documents reviewed, M/s Wilshire Labs Pvt Ltd Lahore is
considered to be operating at an acceptable level of compliance
with respect to GMP guidelines for pharmaceutical product.
The firm was further advised to submit CAPA report with
respect to the current inspection proceedings.
Remark of the Evaluator XI • Letter of deficiencies sent on 21-10-2020 and reminder on
• Mention the salt form of Prucalopride in label claim and
adjust its weight in master formulation considering the salt
form along with submission of applicable fee.
• Submission of stability studies data of three batches as per
guidelines approved in 293rd meeting of Registration
Board.
Decision of 307thmeeting: Deferred for the following:
• Mentioning the salt form of Prucalopride in label claim and adjust its weight in master
formulation considering the salt form along with submission of applicable fee.
• Submission of stability study data as per the guidelines approved in 293rd meeting of
Registration Board.
The firm has submitted revised Form 5D with revised label claim with stability data which presented
below.
Moreover, Fee of Rs. 7500/- is submitted vide slip number 7360335285 dated 08/12/2021 for 2mg
tablet and Rs 7500/- vide slip number 25956780 dated 08/12/2021 for 1mg tablet.
No. of Manufacturer (Proprietary Name + Dosage Initial Diary & Availability
/ Applicant Form + Strength), Date, Fee
a. M/s Wilshire P-Pride 2mg tablet Form 5-D Montegrity (1mg
Laboratories (pvt) Each film coated tablet Dy No. 32446 & 2mg) film
Ltd., 124/1 Quaid e contains: Dated 10/12/2021 coated tablet,
Azam Industial Prucalopride as 14’s, 28’s USFDA
Estate, Kot succinate…….2mg As per SRO Approved
Lakhpat Lahore. Serotonin receptor agonist
In-house specs
b. M/s Wilshire P-Pride 1mg tablet Form 5-D
Laboratories (pvt) Each film coated tablet Dy No. 32446 Copy of GMP
Ltd., 124/1 Quaid e contains: Dated 10/12/2021 certificate No.
Azam Industial Prucalopride as 14’s, 28’s 144/2022-
Estate, Kot succinate…….1mg As per SRO DRAP(AD-
Lakhpat Lahore. Serotonin receptor agonist 4119611790)
issued on the basis
In-house spec of inspection
conducted on
14/09/2022.
Stability data is submitted on 10/12/2021. Fee of Rs. 7500/- is submitted vide slip number
7360335285 dated 08/12/2021 for 2mg tablet and slip number 25956780 dated 08/12/2021 for 1mg
tablet.
Manufacturer of API M/s Zhejiang Guobang Pharmaceutical Co. Ltd., No.6 wei wu road,
Hangzhou gulf shangu industrial zone, Zhejiang China.
API Lot No. 190802
Description of Pack Alu-Alu blister packed in bleach board unit carton with leaflet.
Real Time: 30°C ± 2°C / 65% ± 5%RH
Real Time: 6 Months
Accelerated: 0,1, 2, 3, 4 & 6 (months)
P-Pride 2mg tablet
No. of Batches 03
P-Pride 1mg tablet
Batch No. 001 002 003
No. of Batches 03
1. Reference of previous approval of Panel inspection report for verification of
applications with stability study data of the authenticity of stability data of Velbuvir tablet
firm 400/100 by M/s Wilshire conducted on
23/05/2019. The case was presented in 290th and
291st meeting. The Board approved the case in
293rd meeting.
2. Certificate of Analysis of API from both API The firm has certificate of analysis for relevant
Manufacturer and Finished Product batch used for the product development from
manufacturer. drug substance manufacturer as well as drug
product manufacturer.

manufacturer 48 months
12 months
Batches: (160801, 160802, 160803)
5. Approval of API/ DML/GMP certificate of Copy of GMP certificate number ZJ20180112
API manufacturer issued by concerned valid till 09/04/2023 issued by CFDA.
regulatory
authority of country of origin.
6. Documents for the procurement of API with Copy of attested invoice number ADV-PRU-
approval from DRAP (in case of import). 190302 dated 09/10/2019 issued vide diary
number 13786/2009-DRAP dated 28/10/2019 is
submitted.
10. Complete batch manufacturing record of Firm has provided Batch Manufacturing Record
three stability batches. for all the batches of applied products.
11. Record of comparative dissolution data The firm has submitted comparative dissolution
(where applicable) profile in all the 03 media that is 0.1N HCl,
Phosphate buffer and Acetate buffer against:
• Resolor 1mg & 2mg tablet
13. Compliance Record of HPLC software Firm has submitted certificate of compliance
21CFR & audit trail reports on product and HPLC system reports for analysis for all the
testing. three batches.
14. Record of Digital data logger for Firm has submitted record of digital data logger
temperature and humidity monitoring of for both stability chambers for accelerated as
stability chambers well as real time stability studies.
Evaluation by PEC:
1 Provide analytical method for analysis of The firm has submitted detail of analytical
Prucalopride Succinate from drug method from drug substance manufacturer
substance manufacturer. including detail analytical method for impurities.
2 Valid GMP certificate of drug substance Copy of GMP certificate number ZJ20180112
manufacturer issued by relevant valid till 09/04/2023 issued by CFDA.
authority.
3 Provide the detail of dissolution method Media: 0.1N HCL
and dissolution parameters including Apparatus: Apparatus II (Paddle)
apparatus, rpm, dissolution medium, etc RPM: 50
along with the justification for selection Time: 30minutes
of the parameters. The firm has referred to FDA’s Dissolution
Guidance 2018 for development and selection of
dissolution parameters. However, the firm has
submitted revised dissolution specifications as
per the innovator’s product that is Montegrity
(1mg & 2mg) film coated tablet, USFDA
Approved.
4 Provide detail of the reference / CDP is submitted against P-Pride tablet
innovator’s product (batch number, Manufactured by Janssen approved by European
manufacturer, name of approving Medicine Agency in all the three media that is
authority, expiry etc) against which 0.1N HCl, Phosphate Buffer pH6.8 and Acetate
comparative dissolution profile is Buffer pH4.5.
submitted. Batch number: KLL1P02 (1mg tablet)
Expiry: 11/2023
Batch number: KJL3200 (2mg tablet)
Expiry: 09/2023
5 Provide detail of container closure Alu-Alu blister packed in bleach board unit
system for finished product with detail carton with leaflet.
of outer carton as well.
6 Provide Record of Digital data logger for Submitted.

temperature and humidity monitoring of
stability chambers (real time and
accelerated).
Decision: Registration Board approved the registration of P-Pride 1mg and 2mg film coated
tablet with change of brand name and with innovator’s specifications.
• Manufacturer will submit differential fee of Rs. 67,000/- for each strength for revision of
salt form from Prucalopride to Prucalopride as Succinate.
• Firm will perform dissolution testing as per the parameters (i.e sampling time 20
minutes) of innovator’s product on commercial batches.
Case No. III: Deferred Cases submitted on Form 5F

(local manufacturing)
23. Name, address of Applicant / M/s Saffron Pharmaceutical 19 km,

Marketing Authorization Holder Sheikhupura Road, Faisalabad.
Name, address of Manufacturing site. M/s Saffron Pharmaceutical 19 km,
Sheikhupura Road, Faisalabad.
Status of the applicant ☒ Manufacturer √
☐ Importer
☐ Is involved in none of the above (contract
giver)
☐ Export sale
Dy. No. and date of submission Dated 29.12.2021 Dy.No 33995
Details of fee submitted Rs.20,000/- dated 13.05.2020 Deposit Slip #
0228310
Rs.10,000/- dated 23.11.2021 Deposit Slip #
88095423419
The proposed proprietary name / brand
Doplet-3 Soft Gel Capsule
name
Strength / concentration of drug of Active Each Soft Gel Capsule contains
Pharmaceutical ingredient (API) per unit Cholecalciferol (Vitamin D3)…… 50000 IU
Pharmaceutical form of applied drug Oral Capsule
Pharmacotherapeutic Group of (API) Vitamin D3
USP Specification
specifications
Proposed Pack size 1×10’s, 2×7’s & 3×10’s
Proposed unit price As Per SRO
Approved by MHRA
authorities
For generic drugs (me-too status) DX3 50,000 IU Oral Capsule of Macter
international (Pvt.) Limited.,
GMP status of the Finished product GMP certificate issued on 03.01.2022 (Good
manufacturer Compliance)
Name and address of API manufacturer. Name: M/s Zhejiang NHU Company Ltd.
Address: No.428 Xinchang Dadao West
Road, Qixing Street, Xinchang County,
Zhejiang Province, China
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO QOS-
PD template. Firm has summarized
information related to nomenclature, structure,
general properties, solubilities, physical form,
manufacturers, description of manufacturing
process and controls, impurities,
validation, batch analysis and justification of
specification, reference standard, container
closure system and stability studies of drug
substance and drug product.
Module III (Drug Substance) Firm has submitted detailed data for drug
substance data related to nomenclature,
structure, general properties, solubilities,
manufacturing process and controls,
impurities, specifications, analytical
procedures and its validation, batch analysis
and justification of specification, reference
standard, container closure system and
stability studies of drug substance.
Stability studies Cholecalciferol: Firm has submitted stability
study data of 3 batches of drug substance at
both accelerated as well as real time
conditions. The accelerated stability data is
conducted at 40°C ± 2°C / 75% ± 5% RH for 6
months. The real time stability data is
conducted at 30°C ± 2°C / 75 ± 5% RH for 60
months.
Module-III (Drug Product): Firm has submitted data of drug product
including its description, composition,
pharmaceutical development, manufacture,
manufacturing process and process control,
process validation protocols, control of
excipients, control of drug product,
specifications, analytical procedures,
validation of analytical procedures, batch
analysis, justification of specifications,
reference standard or materials, container
closure system and stability.
Pharmaceutical equivalence and Pharmaceutical Equivalence Studies against
comparative dissolution profile the reference product of “Dan D Soft Gel
Capsule”.
Analytical method validation/verification Firm has submitted verification studies of the
of product drug substance and the drug product.
Manufacturer of API Name: M/s Zhejiang NHU Company Ltd.
Address: No.428 Xinchang Dadao West Road, Qixing
Street, Xinchang County, Zhejiang Province, China
API Lot No. 01201103VD
Description of Pack API Container: Linear low density polyethylene with
(Container closure system) aluminum foil bag vacuum packing
Product Container: Placed in Alu-Alu blister and packed
in unit carton.
Batch No. T-003 T-004 T-005
Batch Size 17000 17000 capsules 17000 capsules
capsules
Manufacturing Date 06.2020 07.2020 07.2020
Date of Initiation 14.07.202
06.08.2020 06.08.2020
0
No. of Batches 03
1. Reference of previous approval of Firm has referred to their last inspection report
applications with stability study data of the for Elixa (Apixaban) 2.5mg & 5mg conducted
firm (if any) on 08.10.2019, approved in 293rd meeting of
Registration Board.
Following are details of few points;
• The HPLC software is 21CFR Compliant.
• Audit trail reports were available and
physically checked by the inspection team.
• Firm has adequate monitoring and controls
for stability chambers.
• Software is installed for continuous
monitoring of chambers.
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate (Certificate#
API manufacturer issued by concerned ZJ20180077) issued by China Food & Drug
regulatory authority of country of origin. Administration valid upto 23.07.2023
3. Documents for the procurement of API Copy of commercial invoice attested by AD

with approval from DRAP (in case of I&E DRAP, Lahore has been submitted.
import). Choloecalciferol:
Date of
Quantity
Batch No. approval
Imported
by DRAP
01201103VD 06Kg 14.01.2021
4. Data of stability batches will be supported Firm has submitted data of stability batches
by attested respective documents like along with batch manufacturing record and
chromatograms, analytical record.
Raw data sheets, COA, summary data
sheets etc.
5. Compliance Record of HPLC software Firm has submitted audit trail reports on
21CFR & audit trail reports on product product testing.
testing
6. Record of Digital data logger for Firm has submitted Record of Digital data
temperature and humidity monitoring of logger for temperature & humidity monitoring
stability chambers (real time and of stability chambers (real time and
accelerated) accelerated)
SUBMITTED DATA REGARDING THE DEFICIENCIES
7. 3.2.P.2 You are following USP Firm has submitted the USP specification &
specification. Compare the USP Comparison of USP pharmacopoeial test
pharmacopoeial test parameters along with parameters along with specification limits
specification limits with applied product
specification.
8. We performed the Identification & assay
method on UV spectrophotometer is internal
3.2.P.2 Clarification of the method of
validated testing method & the validation is
analysis of finished drug product for
performed as per USP general chapter <1225>
quantification of Vitamin D in Assay test,
We performed has Identification & assay
whether UV spectrophotometric method or
method on HPLC is pharmacopeia testing
HPLC method.
method & the verification is performed as per
USP general Chapter <1226>

9. Dissolution test is not included in USP
Dissolution test for the applied product is
monograph so we performed only DT as per
not submitted.
USP.
Decision of 316th meeting:
Deferred for justification of applying UV spectrophotometric method, for Assay test of finished drug
product, whereas USP monograph specifies HPLC method for the Assay analysis.
The firm has submitted assay results at 18th and 24th month time point. The results are reproduced
below.
Assay Contents (%): 90.0 % – 110.0 % (USP)
Assay result is satisfactory on HPLC & UV as shown in table.
Batch # T-003 Batch # T-004 Batch # T-005 Performed

Interval the
Performe Result Performe Performe
s Results Results stability
d date s d date d date
testing
Initial 96.17 105.88 105.82 UV
14.07.2020 06.08.2020 06.08.2020
testing (UV) (UV) (UV)
3rd Month 96.06 102.91 95.21(UV UV
15.10.2020 25.11.2020 25.11.2020
(UV) (UV) )
6th Month 95.74 99.86 99.73 UV
27.01.2021 18.02.2021 18.02.2021
(UV) (UV) (UV)
9th Month 98.94 98.33 99.29 UV
05.05.2021 20.05.2021 20.05.2021
(UV) (UV) (UV)
12th 96.04 99.00 98.79 UV
10.08.2021 28.09.2021 28.09.2021
Month (UV) (UV) (UV)
18th Now we
Month have
performed
the
99.45
96.04 99.68 stability
13.01.2022 21.02.2022 (HPLC 21.02.2022
(UV) (HPLC) testing on
)
HPLC as
per USP
monograp
h
Me-too: VITAMIN D3 SOFTGEL CAPSULES 50,000IU soft gel Capsule Reg. no. 59290
RRA Status: Invita D3 50,000 IU soft Gel Capsule, MHRA Approved
Section approval: Soft gel Capsule Section vide letter No.F.1-12/99-Lic(Vol-I) dated 3rd
December, 2018.
Decision: Approved with USP specifications. Registration Board further decided that the
No.F.7-11/2021-B&A/DRAP dated 07-05-2021.
Moreover, the firm has submitted audit trail report and revised analytical procedure as per USP 43
along with the analytical method verification studies for HPLC method.

24. Name, address of Applicant / M/s Citi Pharma pvt ltd, 3km Head Balloki road Phool
Marketing Authorization Nagar District Kasur.
Holder
Name, address of M/s Citi Pharma pvt ltd, 3km Head Balloki road Phool
Manufacturing site. Nagar District Kasur.
☐ Importer
Intended use of pharmaceutical ☒ Domestic sale
The proposed proprietary name
Panadol Muscle Relaxant Tablet
/ brand name
Strength / concentration of drug Each tablet contains:
of Active Pharmaceutical Paracetamol………..…...650mg
ingredient (API) per unit Orphenadrine Citrate.…..50mg
Immediate release tablet
drug
NSAID, Skeletal muscle relexant
(API)
In-House
specifications
The status in reference
Norgesic Tablets by M/s Inova Pty Limited, TGAAutralia
regulatory authorities
For generic drugs (me-too
Nuberol forte by M/s Searle Paksitan ltd
status)
GMP status of the Finished Copy of GMP certificate No. 158/2019-DRAP(AD-
product manufacturer 700521-1099) dated 13-06-2019 is submitted issued on
the basis of inspection conducted on 19-03-2019.
Name and address of API Paracetamol:
manufacturer. M/s Citi Pharma (pvt) ltd, 3.5-km, head balloki road,
phool nagar Kasur.
Orphenadrine Citrate:
M/s Harika Drugs Pvt Ltd, Sy. No. 165/A & 165/E,
Gummadiadala Village, Sangareddy District, Telangana
State, India.
Module-II (Quality Overall Firm has submitted QOS as per WHO QOS-PD template.
Summary) Summarized information related to nomenclature,
structure, general properties, solubilities, physical form,
manufacturers, description of manufacturing process and
controls, impurities, specifications, analytical procedures
and its verification, batch analysis and justification of
specification, reference standard, container closure system
and stability studies of drug substance and drug product is
submitted.
Module III (Drug Substance) Firm has submitted detailed drug substance data related to
nomenclature, structure, general properties, solubility,
manufacturing process and controls, impurities, residual
solvents, specifications, analytical procedures and its
complete validation studies, batch analysis and
standards, container closure system and stability studies of
drug substance.
Stability studies Paracetamol:
Batches: (PGP-14-37, PGP-14-38, PGP-14-39)
Orphenadrine Citrate:
months
Batches: (HOCAPD005, HOCAPD006, HOCAPD007)
and stability studies of drug product.
Pharmaceutical equivalence and Pharmaceutical equivalence has been established against
comparative dissolution profile Nuberol Forte by M/s Searle Pakistan ltd performing all
the quality tests. (B:C0560).
CDP is submitted against Nuberol Forte by M/s Searle
Pakistan ltd. (B:10MPQVO) in all the three media that is
0.1NHCl, Acetate Buffer 4.5pH and Phosphate Buffer
6.8pH.
Analytical method Analytical method verification/validation studies for drug
validation/verification of product as well as for drug substance are submitted.
product
Manufacturer of API Paracetamol:
M/s Citi Pharma (pvt) ltd, 3.5-km, head balloki road, phool nagar Kasur.
Diphenhydramine hydrochloride:
M/s Harika Drugs Pvt Ltd, Sy. No. 165/A & 165/E, Gummadiadala
Village, Sangareddy District, Telangana State, India.
API Lot No. (Paracetamol)
HOCCPO024 (Orphenadrine citrate)
Description of Pack 3×5’s Blistered in Alu-PVC Packed in standard unit carton.
(Container closure
system)
Stability Storage Real time: 30°C ± 2°C / 65% ± 5%
Condition Accelerated: 40°C ± 2°C / 75% ± 5%RH
Time Period Real time:
Accelerated:
Frequency Accelerated: 0,1,3, 6, (month)
Real Time: 0,1,3, 6, (month)
Batch No. TRA-PMR001 TRA-PMR002 TRA-PMR003
Batch Size 10,000 tab 10,000 tab 10,000 tab
Date of Initiation
No. of Batches 03
1. Reference of previous approval No response is submitted by the firm
of applications with stability
study data of the firm (if any)
2. Approval of API/ DML/GMP Paracetamol (Citi Pharma):
certificate of API manufacturer Copy of GMP certificate no. 01/2021-DRAP(FID-
issued by concerned regulatory 2036001-5101) issued on the basis of inspection
authority of country of origin. conducted on 17/12/2020.
Orphenadrine (Harika Drugs):
Copy of GMP certificate no. L.Dis.No.3390/E1/2019-
WHO GMP certificate issued on 20/11/2019.
3. Documents for the procurement
of API with approval from
DRAP (in case of import).

data sheets etc.

Evidence of approval of the applied formulation in reference regulatory authorities provided in 275th
meeting of Registration Board could not be confirmed.
Decision of 321st meeting: The Board deferred the case for above mentioned points.
No.
1 Valid copies of GMP certificates of Paracetamol (Citi Pharma):
manufacturers of drug substance Copy of GMP certificate no. 01/2021-
(Paracetamol + Orphenadrine Citrate). DRAP(FID-2036001-5101) issued on the
basis of inspection conducted on
17/12/2020.
Orphenadrine (Harika Drugs):
Copy of GMP certificate no.
L.Dis.No.3390/E1/2019-WHO GMP
certificate issued on 20/11/2019.
2 Provide analytical method verification The firm has submitted analytical method
studies including specificity, accuracy verification / validation studies including
and precision for drug substances specificity, accuracy and precision f or
(Paracetamol & Orphenadrine Citrate) paracetamol and orphenadrine drug
performed by drug product substance performed by drug product
3 Provide documents for the procurement The firm has submitted copy of Form 6
of API with approval from DRAP for Dy. No. 10676/2021DRAP dated
Orphenadrine Citrate. 15/07/2021.
No invoice is submitted.
4 Justification is required for selection of Dissolution medium 5.8 pH (Phosphate
dissolution parameter including type of Buffer), sampling time 45mins NLT 75%
apparatus, speed, medium (Phosphate Q.
buffer 5.8pH) and time (45mins- The firm has not provided any reference.
NLT75%(Q))
5 Provide date of initiation of stability Not provided.
studies for all the three batches of the
applied product.
6 Clarification is required regarding the “Askprol CF as applied with our own
brand name of the applied product since brand name and Panadol Muscle
you have provided two brand name that relaxant is applied after getting NOC
is Askprol CF Tablets and Panadol from GSK”
Muscle Relaxant Tablet.
7 The submitted stability study data is till The firm has submitted stability studies
3rd month time point. Please provide till 6 months.
stability study data till 6th month time
point for the applied product.
8 Provide Record of Digital data logger for Submitted.
accelerated) and Compliance Record of
HPLC software 21CFR & audit trail
reports on product testing.
Decision: Deferred for evidence of approval of the applied formulation in reference regulatory
authorities provided in 275th meeting of Registration Board.

Case No. IV: New Section / New License
b. New Section/New License

M/s Pinnacle Biotech (Pvt.) Ltd. Plot No. FD-49-A8, FD-50-A8, FD-51-A8, Korangi Creek Industrial
Park, Karachi is granted New license on 13/09/2021 and has applied for the following
products/molecules; In 321st meeting 03 products and 02 molecules were approved by the Board. Total
number of products and molecules are provided in the table.
Number of molecules Number of products
04 08
25. Name, address of Applicant / M/s Pinnacle Biotech (Pvt.) Ltd. Plot No. FD-49-A8, FD-
Marketing Authorization 50-A8, FD-51-A8, Korangi Creek Industrial Park,
Holder Karachi.
Name, address of M/s Pinnacle Biotech (Pvt.) Ltd. Plot No. FD-49-A8, FD-
Manufacturing site. 50-A8, FD-51-A8, Korangi Creek Industrial Park,
Karachi.
☐ Importer
Intended use of pharmaceutical ☐Domestic sale
Empaxo-M 12.5mg/ 1000mg Tablets
/ brand name
Strength / concentration of drug Each film coated tablet contains:
of Active Pharmaceutical Empagliflozin………...….12.5mg
ingredient (API) per unit Metformin HCl………….1000mg
Blue, Oblong, Film Coated tablet, plain on both sides.
drug
Pharmacotherapeutic Group of Antidiabetics, Biguanides, Antidiabetics, SGLT2
(API) Inhibitors
Innovator’s
specifications
The status in reference SYNJARDY 12.5 /1000mg Tablet by BOEHRINGER
regulatory authorities INGELHEIM PHARMACEUTICALS INC, USFDA
Approved.
For generic drugs (me-too Xenglu-Met 12.5mg/500mg Tablet by Hilton Pharma
status) (Pvt.) Ltd.,
GMP status of the Finished New license granted on 13/09/2021
product manufacturer
Tablet (general), Capsule (general), Sachet (general) and
Research and Development Laboratory section is
approved.
Section approval Tablet (general), Capsule (general), Sachet (general) and
approved
Name and address of API Empagliflozin
manufacturer. M/s. Fuxin Long Rui Pharmaceutical Co. Ltd. Fluoride
Industrial Park, Fumeng County (Yi Ma Tu), Fuxin City,
Liaoning Province -123000, China
Metformin Hcl.
M/s. Exemed Pharmaceuticals Co. Ltd. Block No. 628 (A
& B) ECP Canal Road, Vill : Luna, Taluka: Padra,
District: Vadodara – 391440, Gujarat, India
submitted.
drug substance.
Stability studies Empagliflozin.
Firm has submitted signed and stamped stability data
sheets as per zone IV-A in which real time stability data
Accelerated: 40°C ± 2°C / 75% ± 5%RH 6 months
Batches: L-E-20200409-D01-E06-02, L-E-20200409-
D01-E06-03, L-E-20200409-D01-E06-04
Metformin HCl
sheets as per zone IV-B in which real time stability data
conditions are:
Real time: 30°C ± 2°C / 75% ± 5%RH 72 months
Batches: MFH11001AFP, MFH11002AFP,
MFH11003AFP

Pharmaceutical equivalence and Pharmaceutical equivalence studies with i.e., Xenglu-Met
comparative dissolution profile 12.5mg- 1000mg Tablet by M/s Hilton Pharma whereby
all the quality tests have been performed.
CDP is submitted against the same brand and f2 values are
in the acceptable range.
validation/verification of System Suitability, Linearity, Accuracy, precision,
product Specificity, Limit of Quantification, Limit of Detection,
Robustness.
Manufacturer of API Empagliflozin
M/s. Fuxin Long Rui Pharmaceutical Co. Ltd. Fluoride Industrial Park,
Fumeng County (Yi Ma Tu), Fuxin City, Liaoning Province -123000,
China
Metformin Hcl.
M/s. Exemed Pharmaceuticals Co. Ltd. Block No. 628 (A & B) ECP
Canal Road, Vill : Luna, Taluka: Padra, District: Vadodara – 391440,
Gujarat, India
API Lot No. Empagliflozin
H-E-20210605-D01-E06-02
Metformin HCl
MFH211237AFP
Description of Pack
(Container closure Alu-Alu blister packed in unit carton (2×7’s)
system)
Frequency Accelerated: 0, 2, 4, 6 (Months)
Batch No. 22TTEMM001 22TTEMM002 22TTEMM003
No. of Batches 03
certificate of API manufacturer Copy of GMP certificate No. LN210011 dated26/05/2021
issued by concerned regulatory issued by Lioning Drug Administration.

Copy of GMP certificate No. 21082838 dated 07/08/2021
valid till 06/08/2024 issued by Food and Drugs Control
Adminsitrtaion Gujarat India.
3. Documents for the procurement Empagliflozin : Copy of Form 6 No. 942 dated 10/12/2021
of API with approval from and Copy of attested invoice No. HN20211027-A dated
DRAP (in case of import). 30/11/2021.
Metformin: Copy of attested invoice no.
GSTVAD2122427 dated 23/11/2021.
data sheets etc.
Provide analytical method verification Submitted.

studies including specificity, accuracy and
precision for drug substances
(Empaglilozin+Metformin HCl) performed
by drug product manufacturer.
Submitted stability study data is till 3rd The firm has submitted stability studies till
month time point while the stability studies 6th month time point.
till 6th month is required.
Please provide pharmaceutical equivalence Pharmaceutical equivalence studies against
data and CDP for the applied product along Xenglu-Met 12.5mg- 1000mg Tablet
with the details of the reference/innovator’s whereby all the quality tests have been
product (Batch Number, expiry, performed by performing all the quality
manufacturing date etc) against which the tests.
said studies have been performed. CDP is submitted against the same brand
and f2 values are in the acceptable range in
all the 03 media that is 0.1N HCl, Acetate
Buffer and Phosphate Buffer.
Decision: Approved.
26. Name, address of Applicant / M/s Pinnacle Biotech (Pvt.) Ltd. Plot No. FD-49-A8, FD-
Marketing Authorization 50-A8, FD-51-A8, Korangi Creek Industrial Park,
Holder Karachi.

Name, address of M/s Pinnacle Biotech (Pvt.) Ltd. Plot No. FD-49-A8, FD-
Manufacturing site. 50-A8, FD-51-A8, Korangi Creek Industrial Park,
Karachi.
☐ Importer
Dapamax-M 5mg/ 850mg Tablets
/ brand name
of Active Pharmaceutical Dapagliflozin as propanediol monhydrate……5mg
ingredient (API) per unit Metformin HCl………….850mg
Blue, Oblong, Film Coated tablet, plain on both sides.
drug
(API) Inhibitors
Inovator’s
specifications
EMA Approved
DapaMet 5/850mg by M/s Hilton Pharma
status)
GMP status of the Finished New license granted on 13/09/2021
product manufacturer Tablet (general), Capsule (general), Sachet (general) and
approved.
Section approval Tablet (general), Capsule (general), Sachet (general) and
approved
Name and address of API Dapagliflozin:
manufacturer. M/s. Fuxin Long Rui Pharmaceutical Co. Ltd. Fluoride
Metformin Hcl.
submitted.
drug substance.
Stability studies Dapagliflozin:
sheets as per zone IV-A in which real time stability data
Batches: DG-20201120-D05-DGM6-01, DG-20201120-
D05-DGM6-02, DG-20201120-D05-DGM6-03
Metformin HCl
sheets as per zone IV-B in which real time stability data
conditions are:
MFH11003AFP
Pharmaceutical equivalence and Pharmaceutical equivalence is established against Dapa-
comparative dissolution profile Met 5/850mg tablet by M/s Hilton Pharma by performing
all the quality tests
CDP is submitted against Dapa-Met 5/850mg tablet by
M/s Hilton Pharma (Batch number: 142465) in all the 3
media that in Phosphate Buffer, Acetate Buffer and 0.1N
HCl.
validation/verification of System Suitability, Linearity, Accuracy, precision,
product Specificity, Limit of Quantification, Limit of Detection,
Robustness.

Manufacturer of API Dapagliflozin
M/s. Fuxin Long Rui Pharmaceutical Co. Ltd. Fluoride Industrial Park,
Fumeng County (Yi Ma Tu), Fuxin City, Liaoning Province -123000,
China
Metformin Hcl.
M/s. Exemed Pharmaceuticals Co. Ltd. Block No. 628 (A & B) ECP
Canal Road, Vill : Luna, Taluka: Padra, District: Vadodara – 391440,
Gujarat, India
API Lot No. Dapagliflozin:
L-DG-20210805-D02-DG06-01
Metformin HCl
MFH211237AFP
Description of Pack
system)
Batch No. 22TTDAM003 22TTDAM004 22TTDAM005
No. of Batches 03
8. Approval of API/ DML/GMP Dapagliflozin:
certificate of API manufacturer Copy of GMP certificate No. LN210011 dated26/05/2021
issued by concerned regulatory issued by Lioning Drug Administration.
Copy of GMP certificate No. 21082838 dated 07/08/2021
valid till 06/08/2024 issued by Food and Drugs Control
Adminsitrtaion Gujarat India.
9. Documents for the procurement Dapagliflozin:
of API with approval from Copy of invoice no. HN20211027-A dated 30-11-2021
DRAP (in case of import). cleared on 10/12/2021.
Metformin:
Copy of attested invoice no. GSTVAD2122427 dated
23/11/2021.
data sheets etc.

Provide analytical method verification The firm has submitted analytical method
studies including specificity, accuracy and verification studies for Metformin and
precision for drug substances Dapagliflozin drug substances performed by
(Dapaglilozin+Metformin) performed by drug product manufacturer.
Submitted stability study data is till 3rd Submitted.
month time point while the stability studies
Please provide pharmaceutical equivalence Pharmaceutical equivalence is established
data and CDP for the applied product along against Dapa-Met 5/850mg tablet by M/s
with the details of the reference/innovator’sHilton Pharma by performing all the quality
product (Batch Number, expiry,tests
manufacturing date etc) against which the CDP is submitted against Dapa-Met
said studies have been performed since 5/850mg tablet by M/s Hilton Pharma
submitted data is against the comparator’s (Batch number: 142465) in all the 3 media
product. that in Phosphate Buffer, Acetate Buffer and
0.1N HCl.
Justify the selection of dissolution `The firm has referred to FDA’s dissolution
parameters for the applied product including guideline 2018 for selection and
dissolution media, rpm, sampling time etc. development of dissolution method,
specifications and parameters.
Provide complete batch manufacturing Submitted.
record for the applied product.
Provide Compliance Record of HPLC Submitted.
software 21CFR & audit trail reports on
product testing.
Provide documents confirming import of Copy of invoice no. HN20211027-A dated
Dapagliflozin. 30-11-2021 cleared on 10/12/2021.
Decision: Approved.
27. Name, address of Applicant / M/s Pinnacle Biotech (Pvt.) Ltd. Plot No. FD-49-A8,
Marketing Authorization Holder FD-50-A8, FD-51-A8, Korangi Creek Industrial Park,
Karachi.
Name, address of Manufacturing M/s Pinnacle Biotech (Pvt.) Ltd. Plot No. FD-49-A8,
site. FD-50-A8, FD-51-A8, Korangi Creek Industrial Park,
Karachi.
☐ Importer
Dapamax-M 5mg/ 81000mg Tablets
brand name
Active Pharmaceutical ingredient Dapagliflozin as propanediol monhydrate……5mg
(API) per unit Metformin HCl………….1000mg
Pharmaceutical form of applied drug Blue, Oblong, Film Coated tablet, plain on both sides.
(API) Inhibitors
Innovator’s
specifications
EMA Approved
authorities
For generic drugs (me-too status) DapaMet 5/1000mg by M/s Hilton Pharma
GMP status of the Finished product New license granted on 13/09/2021
manufacturer Tablet (general), Capsule (general), Sachet (general)
and Research and Development Laboratory section is
approved.
Section approval Tablet (general), Capsule (general), Sachet (general)
and Research and Development Laboratory section is
approved
Name and address of API Dapagliflozin:
manufacturer. M/s. Fuxin Long Rui Pharmaceutical Co. Ltd.
Fluoride Industrial Park, Fumeng County (Yi Ma Tu),
Fuxin City, Liaoning Province -123000, China
Metformin Hcl.
M/s. Exemed Pharmaceuticals Co. Ltd. Block No.
628 (A & B) ECP Canal Road, Vill : Luna, Taluka:
Padra, District: Vadodara – 391440, Gujarat, India

sheets as per zone IV-A in which real time stability
data
Batches: DG-20201120-D05-DGM6-01, DG-
20201120-D05-DGM6-02, DG-20201120-D05-
DGM6-03
Metformin HCl
sheets as per zone IV-B in which real time stability
data conditions are:
MFH11003AFP
comparative dissolution profile Dapa-Met 5/1000mg tablet by M/s Hilton Pharma by
performing all the quality tests
CDP is submitted against Dapa-Met 5/1000mg tablet
by M/s Hilton Pharma (Batch number: 142322) in all
the 3 media that in Phosphate Buffer, Acetate Buffer
and 0.1N HCl.
validation/verification of product System Suitability, Linearity, Accuracy, precision,
Specificity, Limit of Quantification, Limit of
Detection, Robustness.
Manufacturer of API Dapagliflozin

M/s. Fuxin Long Rui Pharmaceutical Co. Ltd. Fluoride
Metformin Hcl.
API Lot No. Dapagliflozin:
L-DG-20210805-D02-DG06-01
Metformin HCl
MFH211237AFP
Description of Pack
Alu-Alu blister packed in unit carton (2×7’s)
Stability Storage Condition Real time: 30°C ± 2°C / 65% ± 5%
Batch No. 22TTDAM001 22TTDAM002 22TTDAM003
No. of Batches 03
1. Reference of previous approval of No response is submitted by the firm
2. Approval of API/ DML/GMP Dapagliflozin:
certificate of API manufacturer Copy of GMP certificate No. LN210011
issued by concerned regulatory dated26/05/2021 issued by Lioning Drug
authority of country of origin. Administration.
Metformin:
Copy of GMP certificate No. 21082838 dated
07/08/2021 valid till 06/08/2024 issued by Food and
Drugs Control Adminsitrtaion Gujarat India.
3. Documents for the procurement of Dapagliflozin:
API with approval from DRAP (in Copy of invoice no. HN20211027-A dated 30-11-2021
case of import). cleared on 10/12/2021.
Metformin:
Copy of attested invoice no. GSTVAD2122427 dated
23/11/2021.
sheets etc.

on product testing
accelerated)
Provide analytical method verification The firm has submitted analytical method
studies including specificity, accuracy and verification studies for Metformin and
precision for drug substances Dapagliflozin drug substances performed by
(Dapaglilozin+Metformin) performed by drug product manfuactrer.
Submitted stability study data is till 3rd Submitted.
month time point while the stability studies
Please provide pharmaceutical equivalence Pharmaceutical equivalence is established
data and CDP for the applied product along against Dapa-Met 5/1000mg tablet by M/s
with the details of the reference/innovator’sHilton Pharma by performing all the quality
product (Batch Number, expiry,tests
manufacturing date etc) against which the CDP is submitted against Dapa-Met
said studies have been performed since 5/1000mg tablet by M/s Hilton Pharma
submitted data is against the comparator’s (Batch number: 142322) in all the 3 media
product. that in Phosphate Buffer, Acetate Buffer and
0.1N HCl.
Justify the selection of dissolution `The firm has referred to FDA’s dissolution
parameters for the applied product including guideline 2018 for selection and
dissolution media, rpm, sampling time etc. development of dissolution method,
specifications and parameters.
Provide complete batch manufacturing Submitted.
record for the applied product.
Provide Compliance Record of HPLC Submitted.
product testing.
Provide documents confirming import of Copy of invoice no. HN20211027-A dated
Dapagliflozin. 30-11-2021 cleared on 10/12/2021.
Decision: Approved.
May & Baker Pvt. Ltd, Lahore:
28. Name, address of Applicant / M/s May & Baker (pvt) Ltd., 45km, Dina Nath,
Marketing Authorization Holder Multan road, Lahore.
Name, address of Manufacturing M/s May & Baker (pvt) Ltd., 45km, Dina Nath,
site. Multan road, Lahore.

☐ Importer
Fanak 75mg/mL Solution for Injection
brand name
Strength / concentration of drug of Each ampoule (3mL) contains:
Active Pharmaceutical ingredient Diclofenac as sodium…….75mg
(API) per unit
Solution for Injection (IV/IM)
drug
NSAID
(API)
specifications
Proposed Pack size 1’s, 5’s, 10’s, 30’s
Voltarol 75mg/3mL Injection, MHRA Approved.
authorities
For generic drugs (me-too status) Dicloran 75mg/3mL by M/s Sami Pharma
GMP status of the Finished product DML issued vide letter No.F.1-10/2019-Lic dated
Section approval Injectable Ampoule Section (General)
Name and address of API M/s Henan Dongtai Pharm Co., Ltd., East Changhong
manufacturer. road of Tangyin county, Anyang city, Henan
province, China.
months
months
Batches: (101130-1, 101130-2, 101130-3)
comparative dissolution profile Dicloran Injection by performing quality tests.
Brand name: Dicloran 75mg/mL
Batch number: 066H
Mfg date: June, 2022
Mfg by: M/s Sami Pharma
validation/verification of product accuracy/recovery, precision, specificity etc for drug
Manufacturer of API M/s Henan Dongtai Pharm Co., Ltd., East Changhong road of
Tangyin county, Anyang city, Henan province, China.
Description of Pack
Type I glass ampoule packed in unit carton
Batch No. Trial 01 Trial 02 Trial 03
Batch Size 1000 ampoules 1000 ampoules 1000 ampoules
No. of Batches 03

2. Approval of API/ DML/GMP Not submitted.
certificate of API manufacturer
issued by concerned regulatory
API with approval from DRAP (in Copy of Invoice no. 2020FP07013 dated 02/07/2020
case of import). cleared on 27/07/2020.

data sheets etc.
5. Compliance Record of HPLC Not Submitted
No.
1 As per submitted dossier, testing for assay of drug The firm has submitted
substance is done according to USP (titration method) analytical method verification
while the submitted verification studies for analytical report.
method is provided for HPLC method, clarify or
otherwise provide method verification studies
considering USP monograph along with the relevant
documents.
2 Provide detail of the product against which Brand name: Dicloran
pharmaceutical equivalence has been performed 75mg/mL
including name of manufacturer, batch number, expiry Batch number: 066H
and manufacturing date. Mfg date: June, 2022
Mfg by: M/s Sami Pharma
3 Provide complete manufacturing method for the Submitted.
applied product since the provided method does not
provide complete information regarding the process.
4 Provide the required detail of reference standard Submitted COA of USP
including COA. reference standard of Lot#
R038G0
5 As per submitted certificate of analysis of drug It was a drafting error. The
substance from drug product manufacturer, the assay assay was calculated on dried
value on as-is basis is 98.5% and the assay (on dried basis and drug product
basis) was calculated and found to be 98.895% which manufacturer has adopted the
is out of specifications as per the limits defined by USP. USP method for assay on
Moreover, the calculation of assay value on dried basis dried basis.
is pharmacopoeial requirement and product
development has been performed without fulfilling the
compendial requirements, please clarify.
6 Provide documents confirming import of API used for • Firm has submitted copy
product development. of letter from M/s Global
Pharmaceuticals, for the
grant of Loan of API’s
including Diclofenac
sodium for stability and
registration purpose.
Firm has submitted copy of
commercial invoice in name
of M/s Global
Pharmaceuticals for import of
1000Kg of Diclofenac
sodium, attested by AD I&E
DRAP, Islamabad dated 27-
07-2020.
7 Justification is required since the assay value at initial It was a drafting error.
time points are different for accelerated and real time
stability studies.
8 As per submitted dossier, the chromatograms were It was a drafting error of
generated from 07/03/2022 and accordingly the rest of dates on the stability data
the testing was performed but the as per section 3.2.P.8, sheets
the stability study was started on 07/02/2022, please
clarify and provide audit trail report for establishing the We have manual HPLC
relevancy between the assay values and the provided software. We are now
chromatograms. purchasing 21CFR which is
in pipeline.
Decision: Approved.
• Manufacturer shall follow USP monograph for the drug substance analysis during
commercialmanufacturing of drug product.
• Firm shall submit pharmaceutical equivalence studies against reference product i.e.,
Voren 75mg/3mL injection befire issuance of registration letter.
29. Name, address of Applicant / Marketing M/s May & Baker (pvt) Ltd., 45km, Dina
Authorization Holder Nath, Multan road, Lahore.
Name, address of Manufacturing site. M/s May & Baker (pvt) Ltd., 45km, Dina
Nath, Multan road, Lahore.
☐ Importer
giver)
☐ Export sale

Ozole 40mg dry powder vial IV
name
Strength / concentration of drug of Active Each vial contains:
Pharmaceutical ingredient (API) per unit Omeprazole as sodium……40mg
Pharmaceutical form of applied drug Dry powder for solution for IV injection
Pharmacotherapeutic Group of (API) PPI
specifications
Proposed Pack size 1’s
MHRA Approved
authorities
For generic drugs (me-too status) Risek for injection, Getz Pharma
GMP status of the Finished product DML issued vide letter No.F.1-10/2019-Lic
manufacturer dated 29/04/2022.
Section approval Dry Powder Vial Section (General)
Name and address of API manufacturer. M/s Vision Pharmaceuticals (pvt) ltd., plot
no. 22-23, Industrial triangle, Kahuta road,
Islamabad.
PD template. Summarized information
related to nomenclature, structure, general
properties, solubilities, physical form,
manufacturers, description of
procedures and its verification, batch
analysis and justification of specification,
reference standard, container closure
system and stability studies of drug
substance and drug product is submitted.
Module III (Drug Substance) Firm has submitted detailed drug substance
data related to nomenclature, structure,
general properties, solubility, physical
form, manufacturers, description of
impurities, residual solvents, specifications,
analytical procedures and its complete
validation studies, batch analysis and
justification of specification, details of
reference standards, container closure
substance.
Stability studies • Real time: 30°C ± 2°C / 65% ± 5%RH
for 12 months
• Accelerated: 40°C ± 2°C / 75% ±
5%RH for 6 months
Batches: (1709901, 1607901, 1704901)

Module-III (Drug Product): The firm has submitted detail of
procedure and its validation studies, batch
reference s tandard, container closure
Pharmaceutical equivalence and Pharmaceutical equivalence is performed
comparative dissolution profile against Risek by Getz Pharma.
Analytical method validation/verification of Method validation studies have submitted
product including accuracy/recovery, precision,
specificity etc for drug substance and drug
product.
Manufacturer of API M/s Vision Pharmaceuticals (pvt) ltd., plot no. 22-23,
Industrial triangle, Kahuta road, Islamabad.
API Lot No. 2203902
Description of Pack
Amber colored glass vial with rubber stopper
Batch No. 001 002 003
Batch Size 1000 vials 1000 vials 1000 vials
No. of Batches 03
1. Reference of previous approval of --
firm (if any)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate no. F3-26/2019-
API manufacturer issued by concerned Addl.Dir.(QA&LT-I)-56 isued on the basis
regulatory authority of country of origin. of inspection conducted on 14-06-2022.

approval from DRAP (in case of import). Locally purchased
4. Data of stability batches will be supported Submitted

by attested respective documents like

5. Compliance Record of HPLC software Not submitted
testing
accelerated)
No.
1 Provide compliance Record of HPLC We are now purchasing software 21CFR
software 21CFR & audit trail reports on which is in pipeline.
product testing.
2 Provide date on which the batches were Three trial batches were manufactured on
placed on stability and batch sizes. 01/03/2022
Batch size: 1000 vials
3 Provide complete batch manufacturing The weight of drug substance has not been
record for the applied product. adjusted. The firm has used 40mg of
Omeprazole Sodium as per submitted
BMR.
4 As per submitted specification in section We had to do the formulation of ozole
3.2.P.4. the limit of water content is NMT according to Omeprazole Sodium but we
3% while in stability summary sheets the factored in here whose value is 1.06.
limit is 4.5-10% and, the results of water According to your query, we keep the value
content are more than 5% which is not of water more than 5%. Factor wise we put
justifiable, please clarify and provide 3% extra, by adding extra our result is
scientific justification for selection of limit 100%.
of water content.
5 The drug substance manufacturer has We had to do the formulation of ozole
calculated the assay for Omeprazole according to Omeprazole Sodium but we
Sodium on anhydrous basis as well as the factored in here whose value is 1.06.
limit defined for assay is 36-40% for According to your query, we keep the value
complete salt while for the applied product of water more than 5%. Factor wise we put
the assay has been estimated for 3% extra, by adding extra our result is
Omeprazole (base) only, clarify. 100%.
6 Provide copy of GMP certificate of drug Copy of GMP certificate no. F3-26/2019-
substance manufacturer. Addl.Dir.(QA&LT-I)-56 issued on the
basis of inspection conducted on 14-06-
2022.
7 The run time for the applied product in This was printing error, the review data is
20minutes, 3 standards and 2 samples submitted.
were analysed for assay calculation from
10:12 am to 10:14am which is not
practically possible, clarify. The same
observation has been made for subsequent
analyses as well.
Decision: Approved.

• Firm shall dispense the drug substance based on the potency of Omeprazole (base) on
as-is basis for manufacturing of commercial batches.
30. Name, address of Applicant / M/s May & Baker (pvt) Ltd., 45km, Dina Nath,
Marketing Authorization Holder Multan road, Lahore.
Name, address of Manufacturing M/s May & Baker (pvt) Ltd., 45km, Dina Nath,
site. Multan road, Lahore.
☐ Importer
Ozole 20mg Capsule
brand name
Strength / concentration of drug of Each delayed release capsule contains:
Active Pharmaceutical ingredient Omeprazole……20mg
(API) per unit Source of pellets: M/s Vision Pharma
hard capsule containing delayed release pellets
drug
PPI
(API)
USP
specifications
USFDA Approved
authorities
For generic drugs (me-too status) Risek capsule 20mg by Getz Pharma
GMP status of the Finished product DML issued vide letter No.F.1-10/2019-Lic dated
Section approval Capsule Section (General)
Name and address of API M/s Vision Pharmaceuticals (pvt) ltd., plot no. 22-23,
manufacturer. Industrial triangle, Kahuta road, Islamabad.

months
months
Batches: (OMP076, OMP073, OMP090)
Pharmaceutical equivalence and Brand name: Risek Capsule 20mg
comparative dissolution profile Batch #: C03073
Pharmaceutical equivalence nad CDP are submitted.
specificity, LOD/LOQ, Robustness, Solution
stability, system suitability
Manufacturer of API M/s Vision Pharmaceuticals (pvt) ltd., plot no. 22-23, Industrial
triangle, Kahuta road, Islamabad.
API Lot No. OMP1059
Description of Pack
Batch No. 01 02 03
Batch Size 1000 cap 1000 cap 1000 cap
No. of Batches 03
1. Reference of previous approval of
2. Approval of API/ DML/GMP Copy of GMP certificate no. F3-26/2019-
certificate of API manufacturer Addl.Dir.(QA&LT-I)-56 isued on the basis of
issued by concerned regulatory inspection conducted on 14-06-2022.
API with approval from DRAP (in Locally purchased
case of import).

data sheets etc.
5. Compliance Record of HPLC Not Submitted
No.
1 Provide analytical method verification Submitted.
studies for drug substance.
2 Provide comparative dissolution profile Brand name: Risek Capsule 20mg
against the reference / innovator’s product Batch #: C03073
in three media that is 0.1N HCl, Acetate Pharmaceutical equivalence nad CDP are
Buffer and Phosphate Buffer along with the submitted,
submission of pharmaceutical equivalence
studies by performing all the quality tests As per submitted data, the working
and provide batch number , expiry, name of standard used for the testing of CDP is
manufacturer and approval granting Omeprazole Sodium.
authority of the product against which the
said studies have been performed.
3 Complete analytical method verification The applied product contains enteric
studies are required including specificity, coated pellets of Omeprazole while in
accuracy and precision. Please provide the submitted method verification studies the
required studies along with the protocol for peak areas are provided for Omeprazole
analytical method validation studies. Sodium.
4 Provide complete details of primary Firm has submitted details as Alu-Aluu
packaging material of the applied product. blister.
5 Provide analytical procedures of finished Submitted
drug product.
6 Provide complete batch manufacturing As per submitted BMR, 2.5% overage has
record along with the detail of potency been added without any justification.
adjustment. The firm has submitted calculations for
potency adjustment for the trial batches.

7 Provide compliance Record of HPLC Not submitted
product testing.
Decision: Approved.
• Firm shall manufacture commercial batches without overage of drug substance.
• Registration letter will be issued upon submission of analytical method verification
studies for drug substance as well as for drug product from drug product manufacturer
shall be submitted.
Case No. : Priority Applications:

Cases of Paracetamol containing formulations
DRAP Authority in its 147th meeting decided as under:
“In order to ensure the smooth and continuous supply of paracetamol tablets across Pakistan under
prevailing circumstances, the Authority, as one-time exercise, approved incentivization to the
manufacturers in the form of out-of-queue consideration of applications of registration of:
i) 01 generic (me-too) molecule on manufacturing and immediate distribution of at least
15,000 packs of paracetamol tablets with pack size of 200 tablets.
ii) All dosage forms of paracetamol & its combination products with the condition of immediate
manufacturing and distribution.
Accordingly following cases have been evaluated and are placed before the Board
Paracetamol:
31. Name, address of Applicant / M/s Fahmir Pharma Pvt Ltd. Main Mandianwala stop,
Marketing Authorization Holder 26 km, Lahore Jaranwala road, Tehsil Sharaqpur
sharif, Distt. Sheikhupura"
Name, address of Manufacturing M/s Fahmir Pharma Pvt Ltd. Main Mandianwala stop,
site. 26 km, Lahore Jaranwala road, Tehsil Sharaqpur
sharif, Distt. Sheikhupura"
☐ Importer
Dy. No. and date of submission Dy. No. 22082 dated 14-06-2022
Details of fee submitted PKR 30,000/-: dated 08-06-2022
Panamir 500mg Tablet
brand name
Strength / concentration of drug Each tablet contains:
of Active Pharmaceutical Paracetamol……500mg
ingredient (API) per unit
Immediate release tablet
drug
Analgesic
(API)
BP
specifications
Proposed Pack size 1x10’s , 2x10’s, 3x10’s, 5x10’s 10x10’s, 10x20’s,
(500’s 1000’s Jar Pack)
MHRA Approved.
Panadol 500mg tablet by GSK.
status)
GMP status of the Finished Copy of GMP certificate no. 43/2021-DRAP(FID-
product manufacturer 1770625428-536) issues on the basis of conducted on
27/05/2021.
Tablet general section
Name and address of API Zenith chemical Industry Lahore 16 km off
manufacturer. Ferozpur Road, behind Wapda Grid Station 1 KM of
Chandra Road, Lahore
Module III (Drug Substance) The firm as submitted detail of nomenclature, structure,
manufacturers, description of manufacturing process
and controls, specifications, impurity testing for
impurity A-G, analytical procedure and its verification,
B: P11-001, P11-002, P11-003
Module-III (Drug Product): The official monograph of the applied product is
present in B.P. The firm has submitted detail of
and controls, impurities, specifications, analytical
procedure and its verification studies, batch analysis
and justification of specification, reference standard,
container closure system and stability studies of drug
product.
comparative dissolution profile against the brand leader that is Panadol 500mg tablet
by GSK Pharma by performing quality tests
(Identification, Assay, Dissolution, Uniformity of
dosage form) (B:PPXI).
CDP has been performed against the same brand that is
Panadol 500mg Tablet by Fahmir Pharma in 0.1N HCl,
Acetate buffer (4.5pH) & Phosphate Buffer (pH 6.8).
The values for f1 and f2 are in the acceptable range
(B:PPXI).
Analytical method Method validation studies are submitted including
validation/verification of product linearity, range, accuracy, precision, specificity.
Manufacturer of API M/s Zenith chemical Industry Lahore 16 km off
Ferozpur Road, behind Wapda Grid Station 1 KM of
Chandra Road, Lahore
API Lot No. ZPAR20-350
Description of Pack
Alu-Pvc blister packed in unit carton (1×10’s)
Frequency Accelerated: 0, 1, 2, 3, 6 (Months)
Real Time: 0, 3, 6, 9, 12 (Months)
Batch No. Trail -1 Trail -2 Trail -3
No. of Batches 03
1. Reference of previous approval The firm has not submitted any document.
2. Approval of API/ DML/GMP Copy of GMP certificate No. 141/2019-DRAP (AD-
certificate of API manufacturer 813875-228 issued by DRAP valid till 16-12-2019.
3. Documents for the procurement • Invoice No. 00011/0321 dated 05/03/2021 is
of API with approval from DRAP submitted (Local)
(in case of import).

data sheets etc.
5. Compliance Record of HPLC The assay is performed by UV method as per BP.

No.
1 Provide 6 months stability study data The firm has submitted stability data till 6th
(Accelerated and Real time) according month time point.
to the conditions of zone IV_A since 3
months data is submitted.
2 Analytical method verification studies Analytical method verification studies have
for drug substance performed by drug been submitted for Paracetamol drug
product manufacturer. substance performed by drug product
manufacturer.
3 The submitted process validation Our applied product is uncoated tablet.
documents describe the process of film Further, process validation documents and
coating while the applied product is BMRs have been revised and submitted.
uncoated, please clarify. Moreover, as
per the BMR provided in the submitted
dossier, the applied product is film
coated while as per the manufacturing
method and master formula no step of
film coating is involved.
4 Please submit compatibility of Compatibility studies of excipients with the
excipients with the drug substance. drug substance is submitted.
5 Provide record of Digital data logger Submitted.
for temperature and humidity
monitoring of stability chambers (real
time and accelerated).
6 Latest inspection report of drug Copy of GMP certificate no. 43/2021-
product manufacturer. DRAP(FID-1770625428-536) issues on the
basis of conducted on 27/05/2021.
Decision: Approved.
• Manufacturer will place first three production batches on long term stability
studies throughout proposed shelf life and on accelerated studies for six months
as per the commitment submitted in the registration application.
Case No. IIV: Deferred cases submitted on Form 5

32. Name and address of M/s Hi-Med Pharmaceuticals. 208C Sunder Industrial
manufacturer / Applicant Estate, Lahore, Pakistan
Brand Name +Dosage Form + Hivirin 200mg Capsule
Strength
Composition Each Hard Gelatin Capsule Contains:
Ribavirin…200mg
Diary No. Date of R& I & fee Dy No. 25686: 24.07.2018
PKR 20,000/-: 24.07.2018
Pharmacological Group Third generation cephalosporins and beta-lactamase
inhibitors
Type of Form Form 5
Finished Product Specification USP
Pack size & Demanded Price 10’s; As per PRC
Approval status of product in REBETOL® (ribavirin USP) Capsules. USFDA
Reference Regulatory approved
Authorities.
Me-too status RIVAB 200mg Capsule. Reg. No. 83984
GMP status The firm M/s Himed Pharma was inspected on
27.04.2018, wherein grant of DML was recommended
for 4 sections.
Remarks of the Evaluator. • Form 5 and all relevant documents are from
Medpharm Research Lab, which should be from
Hi-Med Pharma. The firm was asked for
clarification. The firm did not reply.
Prevoius decision The Board in its 291st meeting deferred the case for
submission of documents.
Evaluation by PEC • The firm submitted an unsigned Form 5 and did not
submit any other document.
• Decision of 293rd meeting:
• Deferred for submission signed and stamped form 5 along with all relevant documents.
• Submission by the firm:
• The firm has submitted:
• Section approval letter for Tablet General Section
• Signed and stamped Form 5 along with the relevant documents
• Firm has submitted copy of GMP certificate No. 102/2022-DRAP(AD-37320885037)
dated 27-06- 2022 issued on the basis of inspection conducted on 10-06-2022.
• Decision: Approved.
33. Name and address of manufacturer / M/s Rotex Pharma Pvt Ltd., Plot No. 206 & 207.
Applicant industrial Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Gemnil 1g Injection
Strength Lyophilized Powder for Injection
Diary No. Date of R& I & fee Dy.No. 5588 dated: 07/02/2019 Rs.20,000/-
Composition Each Vial Contains:
Gemcitabine as HCL…..…1gm
Pharmacological Group Antineoplastic
Type of Form Form 5
Pack Size & Demanded Price 1’s (26.3mL), Price as per SRO
Approval Status of Product in GEMZAR (gemcitabine) for injection, Lyophilized
Reference powder (200mg/via & 1gm/vial) by M/s Lilly USA,
Regulatory Authorities LLC, USFDA Approved.
Me-too Status ONCOGEM 1gm injection by M/s AJ MIRZA
PHARMA (PVT) LTD., (Imported) Reg. No. 45672
GMP Status Following additional sections were approved vide
letter No.F.1-53/2003-Lic.(Vol-I) dated 13th June,
2017.
• Tablet (oncology)
• Capsule (oncology)
• Liquid vial SVP (oncology)
• Liquid Ampoule SVP (Onclology)
• Dry powder vial (oncology)
• Capsule (Ceph)
• Dry [powder for oral suspension (ceph)
• Dry Powder vial (ceph)
• Dry Powder vial (Ceph)
Remarks of the Evaluator. Evidence of applied formulation/drug already
approved by DRAP (generic / me-too status) along with
registration number, brand name and name of firm with
same strength and filled volume could not be
confirmed.
Decision: Decision of 293rd meeting:
Deferred for confirmation of manufacturing method (powder filling or lyophilization) and
requisite facility.
• The applicant has stated that they had applied for Gemnil 1g & 200mg liquid injection
but these products were deferred in 293rd meeting for confirmation of manufacturing
facility.
• Furthermore, as per the response of the firm, the product will be manufactured in
approved Liquid vial SVP Oncology section.
• The firm has submitted full fee Rs. 30,000/- vide challan number 17153518278 dated
03/08/2022 along with the duplicate dossiers..
• Copy of GMP certificate No. F.3-55/2020-Addl.Dir.(QA&LT-1) issued on the basis of
inspection conducted on12/08/2020.
Label Claim:
Each vial (26.3mL) contains:
Gemcitabine as HCl…….1g
Reference:
1. Gemcitabine IV Infusion 1 g/ 26.3 mL (solution for infusion) Hospira, TGA Australia
approved
2. Gemcitabine Ebewe 80mg Injection By M/s Novartis Reg. no. 66183
The Board discussed that the applied formualtion is approved in reference regualtory authorities
as Lyophilised Powder for Injeciton as well as Solution for Injection and the firm has requested
the change of dosage form of the applied formualtuion from Lyophilised Powder for Injeciton to
Solution for Injection. Keeping in view, the Board deferred the case for furhter clarification of
the applied dosage form from the firm.
The firm has stated that they had applied for Solution for injection and had submitted Rs. 30,000/-
as well.
Decision: Registration Board discussed that the applied formulation is approved in
reference regulatory authorities as Lyophilized Powder for Injection as well as Solution for
Injection. Considering the submission from the applicant that they had applied for solution
for injection, the Board deferred the case for confirmation of applied dosage form from
the initially submitted dossier
34. Name and address of manufacturer M/s Rotex Pharma Pvt Ltd., Plot No. 206 & 207.
/ Applicant industrial Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Gemnil 200mg Injection
Strength Powder for Injection
Diary No. Date of R& I & fee Dy.No. 5600 dated: 07/02/2019 Rs.20,000/-
Gemcitabine as HCL…..…200mg
Pharmacological Group Antineoplastic
Type of Form Form 5
Pack Size & Demanded Price 1’s, Price as per SRO
Approval Status of Product in GEMZAR (gemcitabine) for injection, Lyophilized
Reference powder (200mg/via & 1gm/vial) by M/s Lilly USA,
Regulatory Authorities LLC, USFDA Approved.
Me-too Status ONCOGEM 200mg injection by M/s AJ MIRZA
PHARMA (PVT) LTD., (Imported) Reg. No. 45671
GMP Status Following additional sections were approved vide
letter No.F.1-53/2003-Lic.(Vol-I) dated 13th June,
2017.
• Tablet (oncology)
• Capsule (oncology)
• Liquid vial SVP (oncology)
• Liquid Ampoule SVP (Onclology)
• Dry powder vial (oncology)
• Capsule (Ceph)
• Dry [powder for oral suspension (ceph)
• Dry Powder vial (ceph)
• Dry Powder vial (Ceph)
Remarks of the Evaluator.
Decision: Decision of 293rd meeting:
Deferred for confirmation of manufacturing method (powder filling or lyophilization) and
requisite facility.
• The applicant has stated that they had applied for Gemnil 1g & 200mg liquid injection
but these products were deferred in 293rd meeting for confirmation of manufacturing
facility.
• Furthermore, as per the response of the firm, the product will be manufactured in
approved Liquid vial SVP Oncology section.
• The firm has submitted full fee Rs. 30,000/- vide challan number 17153518278 dated
03/08/2022 along with the duplicate dossiers.
• Copy of GMP certificate No. F.3-55/2020-Addl.Dir.(QA&LT-1) issued on the basis of
inspection conducted on12/08/2020.
Label Claim:
Each vial (5.3mL) contains:
Gemcitabine as HCl…….200mg
Reference:
1. Gemcitabine IV Infusion 200 mg/ 5.3 mL Hospira, TGA Australia approved.
2. Gemcitabine Ebewe 200mg Injection By M/s Novartis Reg. no. 66182
The Board discussed that the applied formualtion is approved in reference regualtory authorities
as Lyophilised Powder for Injeciton as well as Solution for Injection and the firm has requested
the change of dosage form of the applied formualtuion from Lyophilised Powder for Injeciton to
Solution for Injection. Keeping in view, the Board deferred the case for furhter clarification of
the applied dosage form from the firm.
The firm has stated that they had applied for Solution for injection and had submitted Rs. 30,000/-
as well.
Decision: Registration Board discussed that the applied formulation is approved in
reference regulatory authorities as Lyophilized Powder for Injection as well as Solution for
Injection. Considering the submission from the applicant that they had applied for solution
for injection, the Board deferred the case for confirmation of applied dosage form from
the initially submitted dossier.
35. Name and address of manufacturer M/s. Surge Laboratories (Pvt.) Ltd, 10 Km Faisalabad
/ Applicant Road, Bikhi District, Sheikhupura.
Brand Name +Dosage Form + Isofer Injection 1000mg/10ml
Strength
Diary No. Date of R& I & fee Dy. No. 756, 18-09-2014, Rs. 20,000/- (17-09-2014)
Composition Each 10ml contains:
Iron as Iron (III) Isomaltoside 1000……1000mg
Pharmacological Group Iron parenteral preparation
Type of Form Form-5
Finished Product Specification As per Innovator‘s specifications
Pack Size & Demanded Price 10 mL x 5‘s/ As per PRC
Approval Status of Product in Monofer injection

Reference EMA approved
Regulatory Authorities
Me-too Status Monofer injection by Allmed Laboratories
GMP Status The firm is GMP compliant as per inspection

conducted on 26-11-2016.
The firm has submitted that Atomic absorption
spectrophotometer will be procured before
commercial launching of Iron isomaltoside injection.
Currently, they are using their in-house validated

spectrophotometric method for estimation of iron and
also taking help from their mother company
NABIQASIM INDUSTRIES, having the atomic
absorption spectrophotometer for counter testing
verification of R&D trials.
Evidence of same volume already registered with
DRAP required to be verified.
Deferred for confirmation of testing method involving atomic absorption spectrophotometer and
evidence of already registered formulation in same volume as applied by applicant.
The firm has submitted:
• Me too status: Maltoside Injection 1000mg/10ml by M/s NabiQasim Industries, Reg. No.
112739
• Copy of invoice number 75-04-CI-N0313 dated 29-04-2019 for Atomic Absorption with
VGA, copy of goods declaration and copy of packaging list.
Decision: Registration Board deferred the case for confirmation of generic status of the
applied product in same strength and volume.
36. Name and address of manufacturer/ M/s Ethical Loboratories Pvt Ltd, 14 KM, Multan
Applicant Road, Lahore
Brand Name + Dosage Form + OLO 0.1% eye drop solution
Strength
Composition Each ml contains:
Olopatadine HCL…1mg
Diary No. Date of R & I & fee Dy. No. 3456; 25.01.2019
PKR. 20,000/-; 25.01.2019
PKR. 20,000/-; 07.05.2020
Pharmacological Group Other antiallergics
Type of Form Form 5
Finished product Specification USP
Pack size & Demanded Price as per SRO
Approval status of product in Pataday twice daily relief / Patanol (olopatadine
Reference Regulatory Authorities. hydrochloride ophthalmic solution) 0.1%. USFDA
approved.
Me-too status Ogate 0.1% Ophthalmic Solution. Reg. No. 75915
GMP status The firm was inspected on 21.11.2017, wherein renewal
of DML was recommended.
Remarks of the Evaluator • The firm revised the dosage form in line with the
reference product with submission of Rs.
20000/- fee. The fee challan has not been
endorsed by the Division of Budget and
accounts.
• Undertaking at the end of Form 5 is missing.
Previous decision Deferred for following: (M-295th)
• Submission of fee for revision of formulation
after getting endorsement from Budget and
Account Division.
• Submission of undertaking of Form 5.
Evaluation by EPC The firm submitted the required undertaking and copy
of the challan (not been endorsed by the Division of
Budget and accounts).
Registration Board referred the case to QA & LT Division to conduct GMP inspection of Firm
on priority.
The firm has submitted copy of last inspection report dated 08-03-2022. The panel recommended
the renewal of DML.
Eye drops section (Non-Steroidal) approved.
Decision: Registration Board was apprised that the firm had requested change of strength
of the applied formulation from 0.1% to 0.2% Ophthalmic solution. The Board discussed
that since both of the strengths are approved in reference regulatory authorities, therefore
the Board did not accede to the request of firm.
37. Name and address of manufacturer / M/s Rotex Pharma Pvt Ltd. Plot No. 206 & 207.
Applicant Industrial Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Rubidox P 50mg/25ml Injection
Strength
Diary No. Date of R& I & fee Dy. No 5607 dated 07-02-2019 Rs.20,000/-
Doxorubicin hydrochloride…2mg
(as liposomal pegylated)
Pharmacological Group Anthracyclines and related substances
Type of Form Form-5
Pack Size & Demanded Price 1’s(25ml): As per SRO
Approval Status of Product in USFDA (Doxil Liposomal)
Reference
Me-too Status Nagun 50 Injection of M/s. Ghani Brothers registered
in import (Reg. no. 072574)
GMP Status GMP inspection conducted on 19.09.2018 concluded
satisfactory level of GMP compliance.
Remarks of the Evaluator. Terminal sterilization not mentioned
• Packaging material not mentioned submit separate
application for diluent
Previous Decision of Registration Deferred for the following:
Board (M-296) • Submit justification on scientific grounds for not
performing terminal
sterilization of applied formulation.
• Mention type of primary packaging material of
applied formulation
whether it is type I, II, or III glass container..
Response of the Firm • Firm informed that they import ready to fill sterile
bulk solution for infusion.
• Firm submitted that filling of product done under
aseptic condition and prior to filling solution has been
filtered for sterilization.
• Primary packaging material is Glass vial Type-I.
Deferred for clarification regarding availability of diluent whether, it will be procured or it will
be self manufactured. In case of self manufacturing of diluent by M/s Rotex Pharma Pvt Ltd.,
firm shall submit manufacturing process along with detail of manufacturing area in which the
diluent will be manufactured.
• The firm has stated that no diluent is applied and there is no requirement for any diluent
as well.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050718Orig1s060lbl.pdf (Accessed
on 21/07/2022 at 1:50pm).
The Board was apprised that the applied product is in liposomal dispersion and the liposomal
carriers used in the applied formulation have a complex composition. The Board after
deliberation regarding complexity of manufacturing method decided to defer the case for detail
of manufacturing technique and facility including the detail of equipments used in the
manufacturing of the applied product.
The firm has submitted, “We are procuring API in Pegylated Doxorubicin Liposomal in RTF
form (2mg/mL) from M/s Praxin Pharma S.A (Argentina) and not doing Pegylation in our
manufacturing facility”.
The firm has submitted copy of certificate no. 201332022 000001 19 of medicine In bulk
manufactured for export for Pegylated Liposomal Doxorubicin Hydrochloride manufactured by
M/s Praxis Pharma S.A and COA of the API. (storage conditions: 2-80C).
Decision: Registration Board deliberated that the applied product is Pegylated Doxorubicin
Liposomal form with a specific method of manufacturing. Since the firm has not provided
any data related to product manufacturing method, stability data etc therefore, the Board
decided to defer the case for the following points:
• Submission of stability studies including long term and accelerated stability studies
conducted under the conditions of zone IV-A for 03 batches of drug substance that
is Pegylated Liposomal Doxorubicin.
• Submission of complete method of manufacturing of the drug substance.
38. Name and address of manufacturer / M/s Winbrains Research Laboratories. Plot No. 69/1,
Applicant Block B, Phase I-II ,
Industrial Estate, Hattar, Pakistan.
Brand Name +Dosage Form + Flumeth 0.1% Ophthalmic Suspension
Strength
Composition Each ml Contains:
Fluorometholone…1mg
Pharmacological Group Corticosteroids
Type of Form Form 5
Pack Size & Demanded Price 5mL, s per SRO
Approval Status of Product in FML® (fluorometholone ophthalmic suspension,
Reference USP)
Regulatory Authorities 0.1% sterile. USFDA approved.
Me-too Status Floroptic 0.1% Eye Drops. Reg No. 33873
GMP Status
Remarks of the Evaluator. Proof of approved section for the applied product
was asked form the firm. The firm provided
approval of eye drop (general) section..
Previous Decision of Registration Deferred for clarification of the manufacturing facility.
Board (M-293)
Response of the Firm:
• The firm has submitted section approval letter No.F.3-7/2007-Lic(Vol-I) dated 20-09-
2021 for grant of additional section. CLB in its 282nd meeting held on 31st august, 2021
has considered and approved title of Eye Drops (General) section as Eye/Ear/Nasal Drop
(General).
Decision: Approved.
Case No. III: Registration applications for which no response is submitted after issuance of
letter for shortcomings
New Section / New License:

M/s Jaskan Pharmaceuticals (pvt) Ltd. was granted New Section “Injectable (vial) General Section”
vide letter No. F.1-16/2006-Lic (Vol-I) dated 12/03/2021 title of which was corrected in 283rd meeting
of Licensing Board as “Injectable (Vial) (General) (LVP) Section” vide even letter No. dated
18/111/2021.
The firm has applied for 03 pr0ducts and 03 molecules which were considered in 316 th meeting. Now
the firm has applied for 01 product and 01 molecules. The total number applications considered by the
board is given in the following:
No. of Molecules No. of products
05 05
39. Name, address of Applicant / Marketing M/s Jaskan Pharmaceutical Private Limited
Authorization Holder Plot No 50 Sunder Industrial Estate Lahore
Name, address of Manufacturing site. M/s Jaskan Pharmaceutical Private Limited
Plot No 50 Sunder Industrial Estate Lahore
☐ Importer
giver)
☐ Export sale
Cefbo Injection 1gm IM/IV
name
Strength / concentration of drug of Active Each Vial contains:
Pharmaceutical ingredient (API) per unit Cefoperazone as Sodium………. 500mg
Sulbactam as Sodium...................500mg
Pharmaceutical form of applied drug Sterile powder for solution for injection
Pharmacotherapeutic Group of (API) Cephalosporin Antibiotic
JP (Japanese Pharmacopoeia)
specifications
The status in reference regulatory Pharmaceuticals and Medical Devices Agency
authorities (PMDA) of Japan.
For generic drugs (me-too status) Sulzone 1.0gm Injection M/s Biocare
Pharmaceutical by Dawnrays Pharmaceutical
Co,Ltd., Reg. No. 028468
GMP status of the Finished product
manufacturer
Name and address of API manufacturer. Qilu Antibiotics Pharmaceutical CO, Ltd
NO.849 DongJia Town Licheng District, Jinan,
Shandong, China.
template. Summarized information related to
description of manufacturing process and
controls, impurities, specifications, analytical
procedures and its verification, batch analysis
studies of drug substance and drug product is
submitted.
Module III (Drug Substance) Official monograph of the product is present in
JP. The firm as submitted detail of
controls, specifications, analytical procedures
and its verification, batch analysis and
justification of specification, reference
studies of drug substance
Real time: 30°C ± 2°C / 65% ± 5%RH for 24s
months
Accelerated: 40°C ± 2°C / 75% ± 5%RH for 6
months
Batches:(9001HK81NG,9002HK81NG,
9003HK81NG)
procedure and its verification studies, batch
reference standard, container closure system
Pharmaceutical equivalence and Pharmaceutical Equivalence has been
comparative dissolution profile established against the Sulzone 1.0gm Injection
M/s Biocare Pharmaceutical by Dawnrays
Pharmaceutical Co, Ltd., by performing quality
tests (Identification, Assay, Dissolution,
Uniformity of dosage form etc). (B:210312101)
Analytical method validation/verification Method verification studies have submitted
of product including accuracy, precision, specificity.
Manufacturer of API Qilu Antibiotics Pharmaceutical CO, Ltd
NO.849 DongJia Town Licheng District, Jinan , Shandong, China
API Lot No. 9001HK81NG
Description of Pack
Type I 15mL glass vial with fluorobutyl rubber stopper and green color
(Container closure
flip off aluminum seal.
system)
Stability Storage Real time: 30°C ± 2°C / 65% ± 5%RH
Frequency Accelerated: 0,1, 2, 3, 6 (Months)
Real Time: 0, 3, 6, 9, 12, 18 ,24 (Months)
Batch No. LD 01 LD 02 LD 03
Batch Size 100Vials 100Vials 100Vials
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. SD20170569
API manufacturer issued by concerned valid till 25/06/2022 is submitted.
regulatory authority of country of origin.
3. Documents for the procurement of API ADC attested Invoice NO JTRF210911-MQ

with approval from DRAP (in case of Diary No. 14373/204DRAP Dated 24-09-2021.
import).
chromatograms,
sheets etc.
5. Compliance Record of HPLC software
testing
accelerated)
No.
1 Please provide valid copy of GMP
certificate of manufacturer of Drug
substance.
2 Provide analytical method verifications
studies performed by the drug product
manufacturer for drug substance.
3 Pharmaceutical equivalence should be
established against the reference /
innovator’s product but you have
performed the studies against me-too
product, please clarify.
4 As per specifications of drug substance
and COA from the drug substance
manufacturer, the water content must
be less than 4% and 1.9% water content
has been determined while according to
the specifications as provided by J.P of
finished product, the water content
should be less than 1%. Keeping in
view the allowed percentage of water
content, please clarify that how would
the finished product comply the
specification as described by JP for
water content determination if the drug
substance has a content higher than 1%.
5 Submitted stability data is till 3rd month
time point, please submit stability
studies till 6th month timepoint.
6 Please justify the stability studies
without the performance of sterility and
bacterial endo toxins.
7 Provide complete calculations for
potency adjustment considering the
COA from the finished product
manufacturer.
8 Compliance Record of HPLC software
testing
9 Evidence of relevant manufacturing
facility is required.
Decision: Registration Board deferred the case for submission of reply to the above cited
shortcomings within six months.
☐ Importer
giver)
☐ Export sale
Cefbo Injection 2gm IM/IV
name
Pharmaceutical ingredient (API) per unit Cefoperazone as Sodium………. 1000mg
Sulbactam as Sodium...................1000mg
Pharmaceutical form of applied drug Sterile powder for solution for injection
JP (Japanese Pharmacopoeia)
specifications
The status in reference regulatory Pharmaceuticals and Medical Devices Agency
authorities (PMDA) of Japan.
For generic drugs (me-too status) Sulzone 2.0gm Injection M/s Biocare
Pharmaceutical by Dawnrays Pharmaceutical
Co,Ltd., Reg. No. 028469
GMP status of the Finished product cGMP No. FID-797667-1346 issued by DRAP
manufacturer valid till 25/10/2022.
Name and address of API manufacturer. Qilu Antibiotics Pharmaceutical CO, Ltd
NO.849 DongJia Town Licheng District, Jinan,
Shandong, China.
submitted.
Module III (Drug Substance) Official monograph of the product is present in
JP. The firm as submitted detail of
Real time: 30°C ± 2°C / 65% ± 5%RH for 24s
months
months
Batches:(9001HK81NG,9002HK81NG,
9003HK81NG)
comparative dissolution profile established against the Sulzone 2.0gm Injection
M/s Biocare Pharmaceutical by Dawnrays
Pharmaceutical Co, Ltd., by performing quality
Uniformity of dosage form etc). (B:210712201)
Manufacturer of API Qilu Antibiotics Pharmaceutical CO, Ltd
NO.849 DongJia Town Licheng District, Jinan , Shandong, China
API Lot No. 9001HK81NG
Description of Pack
Type I 15mL glass vial with fluorobutyl rubber stopper and green color
(Container closure
flip off aluminum seal.
system)
Frequency Accelerated: 0,1, 2, 3, 6 (Months)
Real Time: 0, 3, 6, 9, 12, 18 ,24 (Months)
Batch No. LE 01 LE 02 LE 03
Batch Size 100Vials 100Vials 100Vials
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. SD20170569
API manufacturer issued by concerned valid till 25/06/2022 is submitted.
3. Documents for the procurement of API ADC attested Invoice NO JTRF210911-MQ

with approval from DRAP (in case of Diary No. 14373/204DRAP Dated 24-09-2021.
import).
chromatograms,
sheets etc.
testing
accelerated)
No.
1 Please provide valid copy of GMP
certificate of manufacturer of Drug
substance.
2 Provide analytical method verifications
studies performed by the drug product
manufacturer for drug substance.
3 Pharmaceutical equivalence should be
established against the reference /
innovator’s product but you have
performed the studies against me-too
product, please clarify.
4 As per specifications of drug substance
and COA from the drug substance
manufacturer, the water content must
be less than 4% and 1.9% water content
has been determined while according to
the specifications as provided by J.P of
finished product, the water content
should be less than 1%. Keeping in
view the allowed percentage of water
content, please clarify that how would
the finished product comply the
specification as described by JP for
water content determination if the drug
substance has a content higher than 1%.
5 Submitted stability data is till 3rd month
time point, please submit stability
studies till 6th month timepoint.
6 Please justify the stability studies
without the performance of sterility and
bacterial endo toxins.
7 Provide complete calculations for
potency adjustment considering the
COA from the finished product
manufacturer.
8 Compliance Record of HPLC software
testing
9 Evidence of relevant manufacturing
facility is required.
Routine applications:
41. Name, address of Applicant / M/s Welmark Pharmaceuticals, plot # 122, Block B,
Marketing Authorization Holder Phase V, Indusrial Estate Hattar, Haripur, KPK.
Name, address of Manufacturing M/s Welmark Pharmaceuticals, plot # 122, Block B,
site. Phase V, Indusrial Estate Hattar, Haripur, KPK.
☐ Importer
Tapentawel tablet 75mg
brand name
Active Pharmaceutical ingredient Tapentadol as hydrochloride…..75mg
(API) per unit
drug
Analgesic, opioids
(API)
Innovators specifications
specifications
USFDA Approved
authorities
For generic drugs (me-too status) Tapento tablet by M/s Sami Pharmaceuticals, Reg. No.
093064
GMP status of the Finished Copy GMP certificate No F.11-96/2021-DRAP-97
product manufacturer issued on the basis of inspection conducted on
11/11/2021.
Name and address of API M/s Precise Chemipharma Pvt Limited, C384, TTC
manufacturer. Industrial area, MIDC, Pawne village, Nawi Mumbai,
India
standards , container closure system and stability studies
of drug substance.
months
months
Batches: (6001012013, 6002012013, 6003012013)
Pharmaceutical equivalence and Pharmaceutical equivalence data is submitted against
comparative dissolution profile the comparator’s product that is Tapento IR 75mg
Tablet by M/s Sami Pharmaceuticals by performing all
the quality tests. (Batch number: 003F)
Comparative dissolution profile is submitted against the
same product that is Tapento IR 75mg tablet by M/s
Sami Pharmaceuticals. The values of F2 are within the
acceptable range.
specificity, LOD/LOQ, Robustness, Solution stability,
system suitability
Manufacturer of API 87.375mg per tablet
API Lot No. 060034102019
Description of Pack
No. of Batches 03
2. Approval of API/ DML/GMP Copy of GMP certificate No. 6102090 issued valid till
certificate of API manufacturer 28/09/2022 by FDA Maharashtra.
3. Documents for the procurement of Copy of attested invoice No. EXPS/0002082/2019-20
API with approval from DRAP (in dated 26/12/2019 dy. No. 128 dated 09/01/2020 is
case of import). submitted.
data sheets etc.
No.
1 As per submitted analytical method for Tapentadol HCl
drug substance, the HPLC method is used for assay
while analytical method validation report shows UV-
performance for validation/verification studies. Please
clarify and submit protocol and complete
validation/verification studies for analytical method of
drug substance.
Moreover, correlate the strengths of dilution prepared
for calculation of assay with the strengths of dilutions
prepared for performing testing of linearity parameter
in analytical method verification studies.
Furthermore, please state that whether you have used
same method of analysis as used by the manufacturer
of drug substance or otherwise. Provide method of
analysis of drug substance from drug substance
manufacturer.
2 Provide certificate of analysis of the batch of drug
substance used for product development from drug
substance manufacturer as well as from the drug
3 Provide pharmaceutical equivalence data against
innovator’s / reference product. The submitted data is
against the comparator’s product.
4 Justification is required for selection of dissolution
parameters including dissolution medium (0.1N HCl),
RPM, time etc.
5 Justify the amount of drug substance that is
87.375/tablet dispensed for potency adjustment by
providing detail of calculations along considering the
assay value i.e 99.8%.
42. Name, address of Applicant / Importer M/s United International Plot No. MR-1/22. 3rd
floor Madina Centre Kutchi gali No. 02,
Marriot road Karachi.
Details of Drug Sale License of importer License No: 0657
Address: United International GNB-F-18/A
Ground floor, F-block, Meher sons estate
Karachi.
Validity: 23/05/2020
Status: By way of wholesale
Name and address of marketing M/s Shandong Qidu Pharmaceuticals Co. Ltd.
authorization holder (abroad) No.17, Hongda road, Linzi district Zibo city,
Shandong province China.
Name, address of manufacturer(s) M/s Shandong Qidu Pharmaceuticals Co. Ltd.
No.17, Hongda road, Linzi district Zibo city,
Name of exporting country China
• Original legalized Free Sale Certificate No. 20190027 issued on 04/12/2019 (validity 2
years) issued by Zibo Market Supervision and Administrative Bureau confirms the free
sale of the following products product.
25% Glucose Injection 20ml:5g
0.9% Sodium chloride Injection 20ml:0.18g
Metronidazole and sodium Chloride injection 100ml:0.5g:0.9g
Ciprofloxacin lactate and Sodium chloride Injection 100ml:0.2g:0.9g
• GMP certificate No. SD20170601 valid till 30/08/2022 issued by China Food and Drug
Administration.
Details of letter of authorization / sole agency agreement
• Original legalized Sole agency agreement is attached. M/s Shandong Qidu Pharmaceutical
Co., Ltd., 17, Hongda Road, Linzi District, Zibo City, Shandong Province, PR China
authorizes M/s United International Plot No. MR-1/22. 3rd floor Madina Centre Kutchi gali
No. 02, Marriot road Karachi for the following 04 products;
• Metronidazole and sodium chloride injection 100mh:0.5g:0.9g
• Ciprofloxacin lactate and sodium chloride injection 100ml:0.2g:0.9g
• 0.9% Sodium chloride injection 20ml:0.18g
• 25% Glucose injection 20mg:5g
☒ Importer
giver)
☐ Export sale
For imported products, specify one the these ☒ Finished Pharmaceutical product import
☐ Buk import and local repackaging
purpose only
Dy. No. and date of submission Dy. No 16558 Dated 09/07/2020
Details of fee submitted Rs. 100,000/- Dated 02/03/2020
The proposed proprietary name / brand Glucose Intravenous Infusion 5g/20ml
name
Strength / concentration of drug of Active Each 20ml infusion bottle contains:
Pharmaceutical ingredient (API) per unit Glucose……………….5g
Pharmaceutical form of applied drug IV Infusion
Pharmacotherapeutic Group of (API) Antihypoglycemic agent/
Reference to Finished product specifications B.P
Proposed Pack size 20ml
Proposed unit price As per PRC
The status in reference regulatory authorities Could not be confirmed
For generic drugs (me-too status) Could not be confirmed
Module-II (Quality Overall Summary) QOS is submitted as per WHO-PD template.
Name, address of drug substance M/s Xiwang Pharmaceutical Co., Lt., Xiwang
manufacturer Industrial Park, Handian Town, Zouping
District, Binzhou City, Shandong province,
China.
Module-III Drug Substance: The firm has submitted;
General information of Drug substance
including manufacturing process and process
controls, description of critical steps and
process validations leading to development of
manufacturing process, detail of impurities,
specifications and detail of container closure
system.
Stability Studies of Drug Substance 6 months Accelerated Stability data of 03
(Conditions & duration of Stability studies) batches at 40oC ±2oC / 75% ± 5%.
36 months Real time stability study data is
conducted at 30oC ±2oC / 65% ± 5% RH.
Detail of Batches:
201506011, 20150612, 201506013
Module-III Drug Product: The firm has submitted
Pharmaceutical Equivalence and Not provided
Comparative Dissolution Profile
Analytical method validation/verification of Verification not provided
product
Container closure system of the drug product Polypropylene ampoule bottle of 20ml
Stability study data of drug product, shelf life 6 months Accelerated Stability data of 03
and storage conditions batches at 40oC ±2oC / 75% ± 5%.
Batch Numbers:
3E14040901, 3E14041001, 3E14041101
• The free sale certificate and CoPP are issued by Zibo Market Supervision and Administration
bureau.
• The submitted free sale certificate shows that the product is available for free sale in exporting
country while the submitted CoPP clearly states the applied product is not registered in China
and it is not authorized to be placed in China, Clarify.
• The address of the applicant, as mentioned in Form 5F, is different from the address mentioned
in Drug Sale License, Clarify and submitt sole agency agreement accordingly.
• Provide evidence of approval of applied formulation in same strength and filled volume in
reference regulatory authorities / agencies which were adopted by the Registration Board in its
275th meeting.
• Provide evidence of applied formulation/drug in same strength and filled volume already
approved by DRAP (generic / me-too status) along with registration number, brand name and
name of firm.
• The GMP certificate of API manufacturer is not traceable from the official website of P.R.
China.
• In section 2.3.S.7.1 (b), the detail of proposed storage conditions, and re-test period/shelf life
is not provided.
• For compendial drugs, the analytical method verification studies are performed instead of
method validation. In section 3.2.S.4.3 of Module 3 the verification studies are not provided,
Clarify. Moreover, the verification studies are applicable on the impurity testing as well.
• According to the monograph provided in British Pharmacopoeia, the assay method for
estimation of glucose content HPLC method is provided. Moreover, glucose reference standard
has been officially adopted by the Ph. Eur, clarify and taking these facts into account further
clarification is required, in section 3.2.S.4.4 of S part of Module III, the assay value for glucose
is not given in the submitted certificate of analysis as well as section 2.3.S.4.1 (Specification)
of QOS does not describe the assay specifications as described in British Pharmacopoeia,
clarify. Likewise, in section 3.2.S.7.3 of S part of Module III, the assay of glucose is required
in stability data summary sheets as well. Only value of specific optical rotation is given.
• In section 3.2.P.2.2, the data for formulation development is not provided in detail. Submit the
required data as per the guidelines provided in 293rd meeting later amended in 296th meeting
of Registration Board.
• Details of container closure system in section 3.2.P.2.4 is required according to the guidelines
provided by the Registration Board.
• Clarification is required since section 3.2.P.5.2 describes the assay method where specific
optical rotation of glucose solution is measured in degrees and then multiplied by a factor
09477 for calculation of assay value, which is not in line with the British Pharmacopoeial
monograph wherein the formulation is analysed for assay value by HPLC method.
• For the drug products present in the official pharmacopoeia, the validation studies are not
performed instead verification tests are mandatory. In section 3.2.P.5.3 the verification studies
are not provided, clarify.
• Submit electronic copy of dossier.
Karachi.
• Original legalized CoPP No. 20190010 issued on 24/10/2019 by Zibo Marke Supervision
and Administration Bureau. The product is not actually on the market for free sale,
however the product is licensed to be place in market for use in exporting country.
Administration.
☒ Importer
giver)
☐ Export sale
purpose only
The proposed proprietary name / brand Ciprofloxacin Injection 0.2g/100ml
name
Pharmaceutical ingredient (API) per unit Ciprofloxacin lactate………0.2g
Pharmaceutical form of applied drug A colorless solution of Ciprofloxacin Lactate in
100ml Ampoule
Pharmacotherapeutic Group of (API) Fluoroquinolones
The status in reference regulatory authorities Ciprofloxacin 200mg/20ml, injection by M/s
Hikma Farmaceutica, USFDA Aprpoved
For generic drugs (me-too status) Bacip Infusion 200mg by M/s Surge
Laboratories, Reg No. 59979
Module-II (Quality Overall Summary) Submitted as per WHO-PD template.
Name, address of drug substance M/s Zhejiang Guorang Pharmaceutical Co.,
manufacturer Ltd., No. 6 Wei Wu road Hangzhou Gulf
ShangYu Industrial Zone, Zhejiang.
Certificate is expired on 06/06/2020.
Module-III Drug Substance: The firm has submitted;
General information of Drug substance
including manufacturing process and process
controls, description of critical steps and
process validations leading to development of
manufacturing process, detail of impurities,
specifications and detail of container closure
system.
Detail of Batches:
120309-1, 120309-2, 120309-3
Module-III Drug Product:
Pharmaceutical Equivalence and Not submitted
Analytical method validation/verification of
product
Container closure system of the drug product Glass
Batch Numbers:
3A14031301, 3A14031302, 3A14031303
bureau. Moreover, the product is not actually present in the market for use in exporting country,
the reason of which is not provided in CoPP.
• The address of the applicant, as mentioned in Form 5F, is different from the address mentioned
in Drug Sale License, Clarify and submit sole agency agreement accordingly.
• Submit Valid copy of Drug Sale License.
• Electronic copy of dossier is required.
• Clarification regarding the primary container is required since according to the submitted
SmPC the primary container is glass vial while description and specifications shows that the
container is glass ampoule.
• The quantitative aqueous pH solubility profile from pH 1.2 to 6.8 at 37oC should be provided
in section 2.3.S.1.3 of quality overall summary (QOS) and in detail in section 3.2.S.1 of module
III..
• GMP certificate of API manufacturer is expired. Submit valid GMP certificate of the
manufacturer.
• The API used for the manufacturing of the finished product is Ciprofloxacin Lactate which has
been tested according to Chines Pharmacopoeia as stated in section 2.3.S.4.1(a) of QOS while
Section 2.3.S.4.3 of QOS and 3.2.S.2 of module III state that the API has been developed
according to B.P. Moreover, British Pharmacopoeial monograph for Ciprofloxacin Lactate is
not available, however, BP describes the monograph for Ciprofloxacin base, Clarify.
• Provide summarized results of validation studies including specificity, accuracy and
repeatability performed by drug product manufacturer in section 2.3.S.4.3 of QOS and the
detail of the same should be provided in section 3.2.S.4 as the product is not pharmacopoeial.
• COA of drug substance from API manufacturer in section 2.3.S.4.4 should be submitted along
with the submission of COA of API from drug product manufacturer for the same batches used
in stability studies.
• Justification of specifications is required including the summary of tests included, analytical
procedures and acceptance criteria in section 2.3.S.4.5 as the API (Ciprofloxacin Lactate) is
not present in USP and B.P.
• Provide COA of reference standard used along with the lot number and source as well as Justify
the use of Ciprofloxacin base as reference standard for analysis of API that is Ciprofloxacin
lactate.
• Clarification is required regarding the manufacturing of the applied product. As per the
submitted dossier, Ciprofloxacin is treated with Lactic Acid to produce Ciprofloxacin Lactate
powder. Ciprofloxacin Lactate is then dispensed to be dissolved in 0.9% solution of NaCl. In
contrast to this, the reference product is manufactured by taking Ciprofloxacin base as API,
with the aid of Lactic Acid which acts as solubilizing agent, aqueous solution of Ciprofloxacin
is prepared. The solution contains Hydrochloric acid as well which is added for pH adjustment.
Justify the difference of manufacturing method scientifically.
• The reference standard used by the finished product manufacturer is Ciprofloxacin
Hydrochloride. Scientifically justify the use of Ciprofloxacin Hydrochloride as Reference
Standard for testing Ciprofloxacin Lactate infusion. Moreover, provide COA of the reference
standard.
• Provide detail of Critical Quality attributes & Critical Process Parameters and Pharmaceutical
Equivalence of applied drug product against reference/comparator/innovator product in section
3.2.P.2 (Pharmaceutical Development).
Karachi.
Administration.
• Original legalized CoPP (certificate no. 20190009) issued on 24/10/2019 (valid till
09/08/2020) by Zibo Market Supervision and Administrative Bureau. The product is
licensed to be placed in the market of exporting country. However, the applied product is
not available for free sale in exporting country. Facilities sand operations conform to
WHO-GMP as per CoPP.
☒ Importer
giver)
☐ Export sale
purpose only
The proposed proprietary name / brand Metronidazole Infusion 0.5g/100ml
name
Pharmaceutical ingredient (API) per unit Metronidazole as hydrochloride………0.5g
Pharmaceutical form of applied drug Almost colorless or pale yellow solution in a
glass vial of 100ml
Pharmacotherapeutic Group of (API)
The status in reference regulatory authorities
For generic drugs (me-too status)
Module-II (Quality Overall Summary) QOS is submitted as per WHO-PD template.
Name, address of drug substance M/s Hubei Hongyuan Pharmacetuical Co., Ltd.,
manufacturer No.126 Dabieshan rod, Industrial and
Economic development zone Luotian County,
Hubei Province, No.3 Hongyuan Road,
Fengshan Town, Loutian County, Huanggang
city, Hubei Province, China.
Module-III Drug Substance: The firm has submitted complete S part of
moule III including general properties of API,
manufacturing process and process controls,
detail of specifications, detail of reference
standard and container closure system.
Detail of Batches:
01120120121, 02230230233, 01120120123
Module-III Drug Product: Description of drug product along with
composition, manufacturing process detail and
process development, control of excipients,
specifications of finished product with
analytical method and its verification studies,
batch analysis’ report, detail of reference
standard and container closure system.
Pharmaceutical Equivalence and Not provided
Analytical method validation/verification of
product
Container closure system of the drug product Metronidazole infusion is presented in glass
vials contains 500mg in 100ml.
Batch Numbers:
3A15072001, 3A15072002, 3A15072003
• Submitted CoPP is expired, however it was valid at the time of submission of dossier.
bureau. Moreover, the product is not actually present in the market for use in exporting country,
the reason of which is not provided in CoPP.
• Submit verification studies including specificity, accuracy and repeatability for analytical
method for API performed by the finished drug product manufacturer for API and Drug
product under relevant sections.
• Provide COAs of the batches API by Drug product manufacturer as well as from the drug
substance manufacturer in section 3.2.S.4.4.
• COA of reference standard used for analysis of API is required in relevant sections including
detail of lot number and source.
• Clarify since the qualitative composition of the applied product is different from the
innovator’s product. Dibasic sodium phosphate and Citric acid are added in innovator’s
product as buffers in addition to Sodium Chloride while the applied product contains Sodium
Chloride only as an excipient. Describe the way for adjusting the pH (which should be in a
range of 4.5-6.0 as per B.P specifications) in case when dibasic sodium phosphate and Citric
acid are not used as buffers.
• Submit verification studies including specificity, accuracy and repeatability for analytical
methods performed by the finished drug product manufacturer in section 3.2.P.4.3.
• Provide detail of Critical Quality attributes & Critical Process Parameters and Pharmaceutical
Equivalence of applied drug product against reference/comparator/innovator product in section
3.2.P.2 (Pharmaceutical Development).
• Submit COA of reference standard along with the lot number and source.
Item No. II: Agenda of Evaluator-VIII (Mr. Muhammad Usman)
45. Name, address of Applicant / Marketing M/s Getz Pharma (Pvt) Ltd. Plot No. 29-30,
Authorization Holder Sector 30, Korangi Industrial Area, Islamabad.
Name, address of Manufacturing site. M/s Getz Pharma (Pvt) Ltd. Plot No. 29-30,
Sector 30, Korangi Industrial Area, Islamabad.
☐ Importer
giver)
GMP status of the drug product Firm has submitted copy of GMP certificate
manufacturer dated 30-10-2019
Evidence of approval of manufacturing Firm has submitted copy of GMP certificate
facility dated 30-10-2019 which specifies Tablet
(General) section.
☐ Export sale
Details of fee submitted PKR 30,000/-: vide deposit slip# 6117667857
The proposed proprietary name / brand name NILAP 20mg/ml solution for Infusion and oral
solution
Strength / concentration of drug of Active Each 1 ml ampoule contains;
Pharmaceutical ingredient (API) per unit Caffeine Citrate 20 mg equivalent to caffeine
………….10mg
Pharmaceutical form of applied drug A clear colourless liquid, free from turbidity and
foreign matter; filled in sterilized USP Type-1
ampoule.
Pharmacotherapeutic Group of (API) Anti-Hypertensive
Reference to Finished product specifications USP
Proposed Pack size 1 ml x 1s, 1ml x 10’s
The status in reference regulatory authorities Peyona 20 mg/mL solution for infusion and oral
solution (MHRA approved).
For generic drugs (me-too status) PEYONA SOLUTION FOR INFUSION.
VIA ENRICO FERMI 1, 65020 ALANNO
(PE), ITALY.
Name and address of API manufacturer. Hebei Guangxiang Pharmaceutical Co, Limited
, Cangzhou City, Hebei Province, China by
China Food and Drug Administration.
template. Firm has summarized information
properties, physical form, manufacturers,
procedures and its validation, batch analysis and
justification of specification, reference standard,
container closure system and stability studies of
drug substance and drug product.
Module-III Drug Substance: Firm has submitted detailed data for both drug
structure, general properties, physical form,
and stability studies of drug substance.
Stability Studies of Drug Substance Firm has submitted stability study data of 3
(Conditions & duration of Stability studies) batches of drug substance at both accelerated as
well as real time conditions. The accelerated
stability data is conducted at 40oC ± 2oC / 75%
± 5% RH for 6 months. The real time stability
data is conducted at 30oC ± 2oC / 65% ± 5% RH
for 6 months.
Module-III Drug Product: Firm has submitted data of drug product
specifications, analytical procedures, validation
of analytical procedures, batch analysis,
justification of specifications, reference
standard or materials, container closure system
and stability.
Pharmaceutical Equivalence and Firm has submitted results of pharmaceutical
Comparative Dissolution Profile equivalence for all the quality tests for their
product against the comparator i.e. Peyona
20mg/ml solution for infusion and oral solution
Analytical method validation/verification of Firm has submitted report of verification studies
product of analytical method of drug substance.
Firm has submitted report of verification of
analytical method for the drug product.
Manufacturer of API Zhejiang Haisen Pharmaceutical Co Ltd. Liushi Street, Dongyang city,
Zhejiang Province China.
API Lot No. B012006006
Description of Pack
1 ml Type 1 Glass Ampoule
Stability Storage Condition Real time : 30°C ± 2°C / 65% ± 5%RH
Batch No. 549DS01 549DS02 549DS03
Batch Size 2500 Ampoule 2500 Ampoule 2500 Ampoule
No. of Batches 03
DOCUMENTS / DATA TO BE PROVIDED ALONG WITH STABILITY STUDY DATA
1. Reference of previous approval of applications Firm has referred to onsite inspection report of
with stability study data of the firm (if any) their product for Mirab (Mirabegron) Extended
Release Tablets 25mg & 50mg on 12th December
2017. Further, the said panel inspection report
was discussed in 277th Drug Registration Board
meeting held on 27th – 29th December 2017. The
case was approved and the inspection report
confirms following points:
• The HPLC software is 21CFR Compliant as
per record available with the firm.
• Audit trail on the testing reports is available.
• Adequate monitoring and control are
available for stability chamber. Chambers are
controlled and monitored through software
having alarm system for alerts as well.
2. Approval of API/ DML/GMP certificate of API GMP Certificate No. HE20190094 issued to
manufacturer issued by concerned regulatory manufacturer Hebei Guangxiang Pharmaceutical
authority of country of origin. Co, Limited , Cangzhou City, Hebei Province,
China by China Food and Drug Administration
3. Documents for the procurement of API with • Firm has submitted copy of commercial
approval from DRAP (in case of import). invoice specifying import of 075 Kg Caffine
Anhydrous . The invoice was signed by AD
(I&E) DRAP field office Karachi dated 13-08-
2020.
4. Data of stability batches will be supported by Firm has submitted complete record of testing
attested respective documents likeof all batches along with chromatograms, raw
chromatograms, Raw data sheets, COA, data sheets, COA and summary data sheets.
5. Compliance Record of HPLC software 21CFR Firm has submitted audit trail record of product
& audit trail reports on product testing testing of HPLC.
and humidity monitoring of stability chambers for temperature and humidity monitoring of real
(real time and accelerated) time and accelerated stability chambers.
Evaluation by PEC:
Following Documents are found deficient:
1. Submit label claim as per innovator product declaring the equivalent content of Caffeine
citrate in terms of the base per unit ml.
2. Submit microbial reports for the sterility testing of drug product during stability studies.
3. USP monograph of “Caffeine citrate injection” mandates use of Theophylline in the
standard solution for Assay test, whereas submitted drug product test method form M/s
Getz does not include any such details. Justification shall be submitted in this regard.
4. It is evident from the submitted analytical record for stability studies that standard solution
preparation & system suitability parameter for Assay test has not been performed as per the
recommendations of USP monograph of “Caffeine citrate injection”.
Query Items Getz Pharma Response
Submit label claim as per innovator Below is the label claim as per innovator product
product declaring the equivalent content declaring the equivalent content of Caffeine
of Caffeine citrate in terms of the base citrate in terms of the base per unit ml.
per unit ml.
Each 1ml ampoule contains:
Caffeine Citrate… 20mg
(equivalent to 10mg Caffeine)
Please refer to Annexure-1 for the SmPC of
innovator product for label claim.
Submit microbial reports for the sterility We would like to inform you that we have
testing of drug product during stability performed Bacterial Endotoxin Test, Sterility
studies. Test and Particulate Matter Test at the time of
Release in line with ICH Q6 requirements which
shows that NILAP is sterile.
As per ICH Q1A, stability studies should include
testing of those attributes that are susceptible to
change during storage and are likely to influence
quality, safety and/or efficacy.
Since aforementioned tests can be affected by any
breach in container closure system, therefore, we
have replaced said tests with container closure
integrity test during stability studies.
Further, this is in line with US-FDA Guidelines
“Container and Closure System Integrity Testing
in Lieu of Sterility Testing as a Component of the
Stability Protocol for Sterile Products” which
states in VI. IMPLEMENTATION as follows:
1. A container and closure system integrity
test may replace sterility testing in a
stability program at time points other than
the product sterility test prior to release
2. Container and closure system integrity
tests do not replace sterility testing
methods for product sterility testing prior
to release.
Please refer to Annexure-2 for reports of Bacterial
Endotoxin Test, Sterility Test, Particulate Matter
Test conducted at batch release and Container
Closure Integrity Test at initial stability study
interval.
USP monograph of "Caffeine citrate This is to bring to your kind attention that in USP
injection" mandates use of Theophylline monograph of "Caffeine Citrate Injection"
in the standard solution for Assay test, Theophylline is used only for resolution purpose
whereas submitted drug product test between Theophylline and Caffeine and not for
method form M/s Getz does not include the calculation purpose.
any such details. Justification shall be As per USP Theophylline is categorized as
submitted in this regard. dangerous goods, therefore, we are unable to
procure it.
Further, in USP monograph RRT (relative
retention time) of Theophylline is given which is
0.70, consequently Theophylline can easily be
identified & reported through its relative retention
time (RRT).
In sample solution, peak of Theophylline is
observed but it is below the reporting threshold
(i.e. less than 0.05%) while the resolution
between Theophylline (observed at RRT 0.73)
and Caffeine is 7.05 (Greater than 6) which
fulfills the requirement of USP resolution criteria.
Please refer to Annexure-3 for sample
chromatogram on enhanced scale showing
resolution of 7.05 between Theophylline and
Caffeine.
It is evident from the submitted Please refer to above point for system suitability
analytical record for stability studies that parameter justification.
standard solution preparation & system
suitability parameter for Assay test has
not been performed as per the
recommendations of USP monograph of
"Caffeine citrate Injection”.
Decision: Registration Board deferred for clarification of following points:
• USP monograph of "Caffeine citrate injection" mandates use of Theophylline in the standard
solution for Assay test, whereas submitted drug product test method from M/s Getz does not
include any such details.
• Non-performance of sterility testing at the start and end of stability studies.
• Submitted Pharmacological group of applied formulation as “Anti-hypertensive”.
46. Name, address of Applicant / M/s Tabros Pharma Pvt. Ltd. L-20/B, Sector-22, Federal B
Marketing Authorization Holder Industrial Area, Karachi
Name, address of Manufacturing site. M/s Tabros Pharma Pvt. Ltd. L-20/B, Sector-22, Federal B
Industrial Area, Karachi
☐ Importer
GMP status of the drug product Firm has submitted copy of covering letter of renewal of
manufacturer DML No. 000106(Formulation) dated 30-06-2020 on which
the approved sections are mentioned including section
namely Tablet (General).
Evidence of approval of manufacturing Firm has submitted copy of covering letter of renewal of
facility DML No. 000106(Formulation) dated 30-06-2020.
☐ Export sale
Details of fee submitted PKR75000 dated: 26.11.2021bearing Deposit Slip No.
62756762
PIXIZ TABLET 100mg/10mg
name
Strength / concentration of drug of Active PIXIZ TABLET 100mg/10mg
Pharmaceutical ingredient (API) per unit Each film coated tablet contains:
Losartan Potassium … 100mg
Amlodipine Besylate equivalent to
Amlodipine ………………...… 10mg
Tabros Specs.
Pharmaceutical form of applied drug Film Coated Tablet
Pharmacotherapeutic Group of (API) Losartan Potassium: Angiotensin II Receptor Antagonist

Amlodipine Besylate: Calcium channel blocker
Reference to Finished product Tabros Specifications
specifications
Proposed Pack size 1x14’s
The status in reference regulatory LosAmlo Tablet 100mg/10mg Krka d.d
authorities Germany/Slowenien. ( ).
For generic drugs (me-too status) Not available
Name and address of API manufacturer. Losartan Potassium:
Zhejiang Huahai Pharmaceutical Co., Ltd.
Chunnan, Duqiao, Linhai Zhejiang, China
GMP Certificate issued by CFDA valid till 26-07-2022
Certificate No. ZJ20170049 (PAGE 18/Corr)

Amlodipine Besylate
m/s smruthi organics limited
a-27, midc, chincholi, tal-mohol, solapur 413255
maharashtra state, india.
GMP Certificate issued by Joint Commissioner &
Controlling Authority , Food & Drug Administration M.S,
Bandra €, Mumbai, India
Certificate No. NEW-WHO-
GMP/CERT/PD/86368/2019/11/30111 (Page 19)
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO QOS-PD template.
Firm has summarized information related to nomenclature,
structure, general properties, physical form, manufacturers,
impurities, specifications, analytical procedures and its
validation, batch analysis and justification of specification,
reference standard, container closure system and stability
studies of drug substance and drug product.
Module-III Drug Substance: Firm has submitted detailed data for both drug substance
data related to nomenclature, structure, general properties,
physical form, manufacturers, description of manufacturing
process and controls, impurities, specifications, analytical
procedures and its validation, batch analysis and justification
system and stability studies of drug substance.
Stability Studies of Drug Substance Firm has submitted stability study data of 3 batches of drug
(Conditions & duration of Stability substance at both accelerated as well as real time conditions.
studies) The accelerated stability data is conducted at 40oC ± 2oC /
75% ± 5% RH for 6 months. The real time stability data is
conducted at 30oC ± 2oC / 65% ± 5% RH for 6 months.
Module-III Drug Product: Firm has submitted data of drug product including its
description, composition, pharmaceutical development,
manufacture, manufacturing process and process control,
process validation protocols, control of excipients, control of
drug product, specifications, analytical procedures,
validation of analytical procedures, batch analysis,
Pharmaceutical Equivalence and Pharmaceutical Equivalence have been established against
Comparative Dissolution Profile the brand leader that is LosAmlo Tablet 100/10mg by
Boehringer Ingelheim, by performing quality tests including
Identification, water content, Assay, Dissolution,
Disintegration.

LosAmlo Tablet 100/10mg by KRKA, d.d., Novo mesto,
Germany in 0.1N HCl (QC medium), Acid media (0.1N
HCl), acetate buffer pH 4.5 & Phosphate Buffer pH 6.8. The
F2 values are found satisfactory.
Analytical method validation/verification Firm has submitted report of validation studies of analytical
of product method of drug substance.
Firm has submitted report of verification of analytical
method for the drug product.
Manufacturer of API Losartan Potassium: USP
Amlodipine Besylate B.P.

M/s SMRUTHI ORGANICS LIMITED
A-27, MIDC, CHINCHOLI, TAL-MOHOL, SOLAPUR 413255
MAHARASHTRA STATE, INDIA.
API Lot No. Losartin Potassium
Batch No. C5458-18-017
Amlodipine Besylate –
Batch No. AMBC 014/19
Description of Pack
(Container closure The proposed pack size of Pixiz Tablet 100/10mg is 1x14’s in Alu—Alu Blister.
system)
Stability Storage Real time : 30°C ± 2°C / 65% ± 5%RH
Frequency Accelerated: 0, 3, 6(Months)
Real Time: 0, 3, 6(Months)
Batch No. TR001-4/PIZ TR002-4/PIZ TR003-4/PIZ
Batch Size 1200 TABLETS 1200 TABLETS 1200 TABLETS
Manufacturing Date June 2021 June 2021 June 2021
No. of Batches 03
1. Reference of previous approval of Firm has referred to onsite inspection report of their product
applications with stability study data of the for Mirab (Mirabegron) Extended Release Tablets 25mg &
firm (if any) 50mg on 12th December 2017. Further, the said panel
inspection report was discussed in 277th Drug Registration
Board meeting held on 27th – 29th December 2017. The case
was approved and the inspection report confirms following
points:
• The HPLC software is 21CFR Compliant as per record
available with the firm.
• Adequate monitoring and control are available for
stability chamber. Chambers are controlled and
monitored through software having alarm system for
alerts as well.
2. Approval of API/ DML/GMP certificate of Losartan Potassium
API manufacturer issued by concerned M/s Zhejiang Huahai Pharmaceutical Co., Ltd.
regulatory authority of country of origin. Valid till 15.10.2024.
Amlodipine Besylate
Valid till 13.11.2022
3. Documents for the procurement of API Losartan Potassium
with approval from DRAP (in case of The firm has importedAPI consignment Zhejiang Huahai
import). Pharmaceutical Co., Ltd. China bearing invoice number
HH20200610R dated 22-06-2020.
Amlodipine Besylate
• The firm has imported commercial consignment of API
from SMRUTHI ORGANICS LIMITED India, bearing
invoice number E-150 dated December 27, 2019 signed by
ADC on 03-01-2020.
4. Data of stability batches will be supported Firm has submitted complete record of testing of all batches
by attested respective documents like along with chromatograms, raw data sheets, COA and
chromatograms, Raw data sheets, COA, summary data sheets.
5. Compliance Record of HPLC software Firm has submitted audit trail record of product testing of
21CFR & audit trail reports on product HPLC.
testing
6. Record of Digital data logger for Firm has submitted record of digital data logger for
temperature and humidity monitoring of temperature and humidity monitoring of real time and
stability chambers (real time and accelerated stability chambers.
accelerated)
Evaluation by PEC:
1. In the standard testing method for testing of DS Losartan Potassium (USP), the wavelength used
by DS Manufacturer is 215nm while the wavelength used by the manufacturer of Product is 220nm
and the wavelength specified in the USP is different.
2. Stability data of Data Product provided is of three (03) months rather than 06 months.
3. Provide copy of letter of licensed sections of CLB.
4. Date of manufacturing of batches is mentioned as June 21 instead of exact date.
Reply of Observations:
S. Deficiencies / Short-comings Justification
No.
1. In the standard testing method for We have been performed Analysis / testing of
testing of testing of DS Losartan Losartan potassium Drug Substance as per USP
potassium (USP), the wavelength monograph and analytical method verification
used by DS manufacturer is 215nm studies as per ICH guidelines, supporting
while the wavelength used by the documents are being attached for your kind
manufacturer of drug product is perusal:
220nm and the wavelength
specified in the USP is different. i. Drug substance analytical method as
per USP.
ii. Drug substance analytical method
verification studies in accordance
with USP.
iii. Revised Certificate of analysis of
drug substance analyzed by USP
method.
2. Stability data of product provided is Initially we have submitted CTD dossier
of three (03) months rather than 06 application with 3 months stability data, later on
months. again we have submitted 6 months stability data
accordingly vide letter DRAP/TAB-REG/03-22,
dated March 2,2022. Copy of acknowledgment
letter is attached for your ready reference.
Decision: Approved with Innovators specifications.
• Firm shall submit the fee of Rs. 7,500/- for correction/pre-approval change/ in product
specifications, as per notification No.F.711/2012-B&A/DRAP dated 13-07-2021.
• Manufacturer will place first three production batches on long term stability studies throughout
proposed shelf life and on accelerated studies for six months as per the commitment submitted in
47. Name, address of Applicant / M/s Tabros Pharma Pvt. Ltd. L-20/B, Sector-22, Federal B
Marketing Authorization Holder Industrial Area, Karachi
Name, address of Manufacturing site. M/s Tabros Pharma Pvt. Ltd. L-20/B, Sector-22, Federal B
☐ Importer
GMP status of the drug product Firm has submitted copy of covering letter of renewal of
manufacturer DML No. 000106(Formulation) dated 30-06-2020 on which
the approved sections are mentioned including section
namely Tablet (General).
facility DML No. 000106(Formulation) dated 30-06-2020.
☐ Export sale
Details of fee submitted PKR75000 dated: 26.11.2021 bearing Deposit Slip No.
579938272
PIXIZ TABLET 100mg/5mg
name
Strength / concentration of drug of Active PIXIZ TABLET 100mg/10mg
Pharmaceutical ingredient (API) per unit Each film coated tablet contains:
Losartan Potassium … 100mg
Amlodipine Besylate equivalent to
Amlodipine ………………...… 5mg
Tabros Specs.
Pharmacotherapeutic Group of (API) Losartan Potassium: Angiotensin II Receptor Antagonist

Amlodipine Besylate: Calcium channel blocker
Reference to Finished product Tabros Specifications
specifications
The status in reference regulatory LosAmlo Tablet 100mg/10mg Krka d.d
authorities Germany/Slowenien. ( ).
Name and address of API manufacturer. Losartan Potassium:
GMP Certificate issued by CFDA valid till 26-07-2022
Certificate No. ZJ20170049
Amlodipine Besylate
m/s smruthi organics limited
a-27, midc, chincholi, tal-mohol, solapur 413255
maharashtra state, india.
GMP Certificate issued by Joint Commissioner &
Controlling Authority , Food & Drug Administration M.S,
Bandra €, Mumbai, India
Certificate No. NEW-WHO-
GMP/CERT/PD/86368/2019/11/30111
Comparative Dissolution Profile the brand leader that is LosAmlo Tablet 100/10mg by
Boehringer Ingelheim, by performing quality tests including
Disintegration.

LosAmlo Tablet 100/10mg by KRKA, d.d., Novo mesto,
Germany in 0.1N HCl (QC medium), Acid media (0.1N
HCl), acetate buffer pH 4.5 & Phosphate Buffer pH 6.8. The
Manufacturer of API Losartan Potassium: USP
Amlodipine Besylate B.P.
A-27, MIDC, CHINCHOLI, TAL-MOHOL, SOLAPUR 413255
MAHARASHTRA STATE, INDIA.
API Lot No. Losartin Potassium
Batch No. C5458-18-017
Amlodipine Besylate –
Batch No. AMBC 014/19
Description of Pack
(Container closure The proposed pack size of Pixiz Tablet 100/10mg is 1x14’s in Alu—Alu Blister.
system)
Batch No. TR003-1/PIZ TR003-2/PIZ TR003-3/PIZ
Manufacturing Date June 2021 June 2021 June 2021
No. of Batches 03
1. Reference of previous approval of Firm has referred to onsite inspection report of their product
applications with stability study data of the for Mirab (Mirabegron) Extended Release Tablets 25mg &
firm (if any) 50mg on 12th December 2017. Further, the said panel
Board meeting held on 27th – 29th December 2017. The case
was approved and the inspection report confirms following
points:
• The HPLC software is 21CFR Compliant as per record
alerts as well.
2. Approval of API/ DML/GMP certificate of Losartan Potassium
API manufacturer issued by concerned M/s Zhejiang Huahai Pharmaceutical Co., Ltd.
regulatory authority of country of origin. Valid till 15.10.2024.
Amlodipine Besylate
Valid till 13.11.2022
3. Documents for the procurement of API Losartan Potassium
with approval from DRAP (in case of The firm has imported API consignment Zhejiang Huahai
import). Pharmaceutical Co., Ltd. China bearing invoice number
HH20200610R dated 22-06-2020.
Amlodipine Besylate
• The firm has imported 5commercial consignment of API
from SMRUTHI ORGANICS LIMITED India, bearing
invoice number E-150 dated December 27, 2019 signed by
ADC on 03-01-2020.
testing
accelerated)
Evaluation by PEC:
1. In the standard testing method for testing of DS Losartan Potassium (USP) , the wavelength used
by DS Manufacturer is 215nm while the wavelength used by the manufacturer of Product is 220nm
and the wavelength specified in the USP is different.
2. Stability data of Data Product provided is of three(03) months rather than 06 months.
S. Deficiencies / Short-comings Justification
No.
1. In the standard testing method for We have been performed Analysis / testing of
testing of testing of DS Losartan Losartan potassium Drug Substance as per USP
potassium (USP), the wavelength monograph and analytical method verification
used by DS manufacturer is 215nm studies as per ICH guidelines, supporting
while the wavelength used by the documents are being attached for your kind
manufacturer of drug product is perusal:
220nm and the wavelength
specified in the USP is different. iv. Drug substance analytical method as
per USP.
v. Drug substance analytical method
verification studies in accordance
with USP.
vi. Revised Certificate of analysis of
drug substance analyzed by USP
method.
2. Stability data of product provided is Initially we have submitted CTD dossier
of three (03) months rather than 06 application with 3 months stability data, later on
months. again we have submitted 6 months stability data
accordingly vide letter DRAP/TAB-REG/03-22,
dated March 2,2022. Copy of acknowledgment
letter is attached for your ready reference.
Decision: Approved with Innovators specifications.
48. Name, address of Applicant / M/s Honig Pharmaceutical Laboratories, 14 km, Adlaya
Marketing Authorization Holder Road, Rawalpindi
Name, address of Manufacturing site. M/s Honig Pharmaceutical Laboratories, 14 km, Adlaya
Road, Rawalpindi
☐ Importer
GMP status of the drug product Copy of current GMP certificate dated 23rd June 2020 is
manufacturer provided.
facility DML No. 000550 (Formulation) for the period commencing
on 28-08-2019 and ending on 27-08-2024, however the copy
of valid DML and status of renewal of DML application is
not provided.
☐ Export sale
Dy. No. and date of submission Dy. No. 1007 Date: 26/10/2021
Details of fee submitted PKR 20000 dated: 28-12-20 .
DES-LOR 5mg Tablet.
name
Pharmaceutical ingredient (API) per unit Desloratidine … 5mg
Pharmaceutical form of applied drug Tablet (General)
Pharmacotherapeutic Group of (API) Anti-Histamine

Reference to Finished product USP Specifications
specifications
Proposed Pack size 1x 10’s (Alu-Alu Blister)
The status in reference regulatory USFDA Approved
authorities Clarinax 5 mg Film coated Tablet
For generic drugs (me-too status) Desloreal 5mg Tablet (M/s Winsfield Pharmaceuticals)
Name and address of API manufacturer. Desloratidne:
M/s Glen Mark Life Sciences Ltd, Plot No. 170-172,
chandramouli Industrial Estate, MoholBazarpeth Solapur,
India
Certificate No. Not Provided
(Conditions & duration of Stability substance at both accelerated as well as real time
studies) conditions. The accelerated stability data is conducted at
40oC ± 2oC / 75% ± 5% RH for 6 months.
The real time stability data is conducted at 30oC ± 2oC / 65%
± 5% RH for 36 months.
Comparative Dissolution Profile the brand leader that Clarinax 5 mg Film coated Tablet , by
M/s Merck Pharmaceuticals performing quality tests
including Identification, water content, Assay, Dissolution,
Disintegration.

Clarinax 5 mg Film coated Tablet, by M/s Merck
Pharmaceuticals in Acid media (0.1N HCl), acetate buffer
pH 4.5 & Phosphate Buffer pH 6.8. The F2 values are found
satisfactory(>50%).
Manufacturer of API M/s Glen Mark Life Sciences Ltd, Plot No. 170-172, chandramouli Industrial
Estate, MoholBazarpeth Solapur, India
GMP Certificate of relevant authorities is not provided

API Lot No. API lot No is mentioned generally as 40000290161 is mentioned in stability study
data sheets
Description of Pack
(Container closure The proposed pack size of DES-LOR 5mg Tablet. is 1x10’s in Alu—Alu Blister.
system)
Real Time: 0, 3, 6,9,12,24(Months)
Batch Size 100000 100000 TABLETS 100000 TABLETS
TABLETS
Date of Initiation 01-2019 01-2019 01-2019
No. of Batches 03
1. Reference of previous approval of • Not Provided
firm (if any)
2. Approval of API/ DML/GMP certificate of Desloratidine:
API manufacturer issued by concerned M/s Glen Mark Life Sciences Ltd, Plot No. 170-172,
regulatory authority of country of origin. chandramouli Industrial Estate, MoholBazarpeth Solapur,
India
3. Documents for the procurement of API The document regarding import of Tramadol HCL is not
with approval from DRAP (in case of Provided.
import).
5. Compliance Record of HPLC software Not Submitted.
testing
6. Record of Digital data logger for Not Submitted.
accelerated)
1. Fee submitted is 20,000 therefore submit remaining 10,000 fee for generic Product.
2. Copy of valid DML and GMP certificate of Drug Product manufacturer is not provided.
3. Submit GMP certificate of Drug Substance manufacturer by relevant authorities.
4. Provide COA of relevant batch(es) of Drug Substance being used during product development and
stability studies, of both Drug Product manufacturer & by Drug Substance / /Active Pharmaceutical
Ingredient manufacture
5. Documents for the procurement of API (of relevant batch) with approval from DRAP.
6. Provide compatibility study protocol along with reports as the excipients being used are different
from the ones mentioned/used in innovator Product (USFDA)
7. The Protocol/method for verification along with detailed reports of analytical method for Drug
Product Desloratadine Tablets is not submitted.
8. In analytical assay testing of Desloratadine Tablets the chromatographic condition (wavelength,
column and injection volume) are different from the ones specified in USP.
9. The test reports for Dissolution testing of Des-Lor Tablets are not submitted.
10. Data of stability batches will be supported by attested respective documents like chromatograms,
Raw data sheets, COA, summary data sheets etc.
11. Record of Digital data logger for temperature and humidity monitoring of stability chambers (real
time and accelerated)
12. Process validation protocol wherein critical process parameters and sampling plan must be
described
13. Detailed raw data sheets shall be submitted for complete stability studies.
14. Detailed BMR shall be submitted for stability trial batches.
15. Compliance Record of HPLC software 21CFR & audit trail reports on product testing is not
submitted.
Decision: Registration Board deferred the case for submission of reply to the above cited shortcomings
within six months of issuance of minutes of 322nd meeting. In case Pharmaceutical Evaluation Cell does
not receive any response from firm within the given time, the case will be placed before Registration
Board for decision.
49. Name, address of Applicant / M/s Honig Pharmaceutical Laboratories, 14 km, Adlaya
Marketing Authorization Holder Road, Rawalpindi
Name, address of Manufacturing site. M/s Honig Pharmaceutical Laboratories, 14 km, Adlaya
Road, Rawalpindi
☐ Importer
GMP status of the drug product Copy of current GMP certificate dated 23rd June 2020 is
facility DML No. 000550 (Formulation) for the period commencing
on 28-08-2019 and ending on 27-08-2024, however the copy
of valid DML and status of renewal of DML application is
not provided.
☐ Export sale
Details of fee submitted PKR 20000 dated: 20-02020 .
MOLTRA TABLET 325mg/37.5mg
name
Active Pharmaceutical ingredient (API) Paracetamol … 325mg
per unit Tramadol HCl … 37.5mg
USP Specs.
Pharmacotherapeutic Group of (API) Analgesic

specifications
Proposed Pack size Alu-Alu/PVC Blisters of 1 x10’s Pack
The status in reference regulatory The combination of Tramadol HCL/Paracetamol
authorities 37.5mg/325mg as Film coated Tablet is MHRA Approved
For generic drugs (me-too status) Rama-D Tablet (M/s Global Pharma, Islamabad)
Name and address of API manufacturer. Paracetamol:
M/s Saakh Pharma (Pvt) Ltd, Plot No. C-7/1, NWIZ, Port
Qasim Authority, Karachi.
Certificate No. 83/2020-DRAP (K) dated 23-06-2020.

Tramadol HCL :
Lucent Drugs (Pvt) Ltd, Survey No. 10, Gaddapotharam
village Telangana India
of specification, reference standard, container closure system
Comparative Dissolution Profile the brand leader that Rama-D Tablet manufactured by M/s
Global Pharma, Islamabad), by performing quality tests
including Identification, water content, Assay, Dissolution,
Disintegration.

Rama-D Tablet 37.5mg/325 mg by M/s Global Pharma
Islamabad in Acid media (0.1N HCl), acetate buffer pH 4.5
& Phosphate Buffer pH 6.8. The F2 values are found
satisfactory(>50%).
M/s Saakh Pharma (Pvt) Ltd, Plot No. C-7/1, NWIZ, Port Qasim Authority,
Karachi.

Tramadol HCL :
Lucent Drugs (Pvt) Ltd, Survey No. 10, Gaddapotharam village Telangana India
API Lot No. API lot No is mentioned generally as 40000290161 but the lot no of individual
API(s) is not mentioned.
Description of Pack
The proposed pack size of Moltra Tablet 37.5/325mg is 1x10’s in Alu—Alu
(Container closure
Blister.
system)
Frequency Accelerated: 0, 3, (Months)
Real Time: 0, 3, (Months)
Batch Size 100000
100000 TABLETS 100000 TABLETS
TABLETS
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of Paracetamol:
API manufacturer issued by concerned M/s Saakh Pharma (Pvt) Ltd, Plot No. C-7/1, NWIZ, Port
regulatory authority of country of origin. Qasim Authority, Karachi.

Tramadol HCL :
Lucent Drugs (Pvt) Ltd, Survey No. 10, Gaddapotharam
village Telangana India
import).
summary data sheets.
testing
accelerated)
Evaluation by PEC:
1. Fee submitted is 20,000 therefore submit remaining 10,000 fee.
2. Copy of valid DML and GMP certificate of Drug Product manufacturer is not provided.
3. GMP certificate of Drug Substance manufacturer (Tramadol HCL) by relevant authorities is not
Provided.
4. Provide results of analysis of relevant batch(es) of Drug Substance performed by Drug Product
manufacturer used during product development and stability studies, along with Certificate of
Analysis (CoA) of the same batch from Drug Substance / /Active Pharmaceutical Ingredient
manufacture.
5. Documents for the procurement of API with approval from DRAP (for Tramadol HCL).
6. Record of Digital data logger for temperature and humidity monitoring of stability chambers (real
7. Justify the excipient being used in Product Development as they are different from the ones
mentioned in innovator Product (as in MHRA)
8. Process validation protocol wherein critical process parameters and sampling plan must be
described
9. Detail Method verification report for drug product shall be submitted.
10. As per submitted analytical record of stability studies the Assay & dissolution test has been
performed by UV spectrophotometric method, whereas Pharmacopoeia monograph mandates
HPLC method for both tests. Justification shall be submitted in this regard.
11. Detailed raw data sheets shall be submitted for complete stability studies.
12. Detailed BMR shall be submitted for stability trial batches.
13. The results of CDP studies in the dissolution medium of 0.1N HCl are contradictory to the
specifications of dissolution test declared in section 3.2.P.5.1.
within six months of issuance of minutes of 322nd meeting. In case Pharmaceutical Evaluation Cell does
not receive any response from firm within the given time, the case will be placed before Registration
Board for decision.
3. Cases of Export Facilitation:

50. Name, address of Applicant / M/s FYNK Pharmaceuticals, 19 km, GT Road, Kalashah
Marketing Authorization Holder Kaku, Lahore
Name, address of Manufacturing site. M/s FYNK Pharmaceuticals, 19 km, GT Road, Kalashah
Kaku, Lahore
☐ Importer
GMP status of the drug product Copy of current GMP certificate dated 08-08-2019 is
Evidence of approval of manufacturing Firm has submitted copy of covering letter for renewal
facility of DML and approval letters of licensed sections.
☐ Export sale
Details of fee submitted PKR 30000 Slip No. 8036710392
TENDOL TABLET 50mg
name
Strength / concentration of drug of Each immediate release Film Coated tablet contains:
Active Pharmaceutical ingredient (API) Tepentadol as Hydrochloride… 50mg
per unit
Pharmacotherapeutic Group of (API) Opioid Analgesic (ATC code : N02AX06)

Reference to Finished product Innovator Specifications
specifications
Proposed Pack size 10’s,20’s & 30’s (Alu-Alu Blister)
Proposed unit price Rs.300 for 10’s
authorities NUCYNTA 50mg (Tepentadol HCL) Tablet
manufactured by Janssen Ortho, LLC, gurabo,
For generic drugs (me-too status) Plaxodol Tablet 50mg (M/s Jenner Pharma,
Skeikhupura)
Registration No. 109504
Name and address of API manufacturer. Tapentadol Hydrochloride:
M/s Ami Life Sciences Private Limited,
Block No. 82/B, ECP Road, Taluka Padra, Gujrat,
India.
Certificate No. 19041306 dated 25-04-2019.
template. Firm has summarized information related to
nomenclature, structure, general properties, physical
analytical procedures and its validation, batch analysis
properties, physical form, manufacturers, description of
specifications, analytical procedures and its validation,
Stability Studies of Drug Substance Firm has submitted stability study data of 3 batches of
(Conditions & duration of Stability drug substance at both accelerated as well as real time
40oC ± 2oC / 75% ± 5% RH for 6 months. The real time
stability data is conducted at 30oC ± 2oC / 65% ± 5% RH
for 24 months.
Not Provided on relevant format and date of initiation
manufacture, manufacturing process and process
control, process validation protocols, control of
excipients, control of drug product, specifications,
analytical procedures, validation of analytical
procedures, batch analysis, justification of
specifications, reference standard or materials, container
Pharmaceutical Equivalence and Pharmaceutical Equivalence study is not performed
Comparative Dissolution Profile against the innovator / Reference Product

Plaxodol Tablet 50mg (M/s Jenner Pharma,
Skeikhupura)
instead of Innovator / Reference Product of same
strength.in Acid media (0.1N HCl), acetate buffer pH 4.5
& Phosphate Buffer pH 6.8. The F2 values are found
satisfactory(>50%).
Analytical method Firm has submitted report of validation studies of
validation/verification of product analytical method of drug substance.
Manufacturer of Tapentadol Hydrochloride:
API M/s Ami Life Sciences Private Limited,
Block No. 82/B, ECP Road, Taluka Padra, Gujrat, India.
API Lot No. Not Provided
Description of Pack
(Container closure The proposed pack size is 10’s,20’s & 30’s Alu-Alu Blister.
system)
Batch No. Not Provided Not Provided Not
Provided
Batch Size Not Provided Not Provided Not
Provided
Manufacturing Not Provided Not Provided Not
Date Provided
Date of Initiation Not
Not Provided Not Provided
Provided
No. of Batches 03
applications with stability study data of
the firm (if any)
2. Approval of API/ DML/GMP Tapentadol Hydrochloride:
certificate of API manufacturer issued M/s Ami Life Sciences Private Limited,
by concerned regulatory authority of Block No. 82/B, ECP Road, Taluka Padra, Gujrat,
country of origin. India.
import).
4. Data of stability batches will be Submitted. However needs to be evaluated in the
supported by attested respective light of date of initiation till completion of stability
data sheets, COA, summary data sheets
etc.
5. Compliance Record of HPLC software Submitted.
testing
6. Record of Digital data logger for Submitted. However needs to be evaluated in the light
temperature and humidity monitoring of of date of initiation till completion of stability
accelerated)
Evaluation by PEC:
1. Provide copy of valid DML.
2. Provide analytical method verification Protocol and test reports for API Tepentadol
Hydrochloride as performed by Drug Product manufacturer.
3. CDP studies are performed against Plaxodol Tablet 50mg (M/s Jenner Pharma, Skeikhupura
manufactured by instead of Innovator / Reference Product of same strength.
4. RSD is not calculated for Robustness , Precision in method validation test reports.
5. Test of accuracy is not performed in method validation of Product development.
6. Provide stability studies summary sheets on Prescribed format as recommended by the DRB
in its 293rd meeting including batch No, batch size, manufacturing date, date of initiation, API
lot No and storage conditions etc.
7. Documents for the procurement of API with approval from DRAP (in case of import) along
with COA of relevant batch needs to be submitted.
Kaku, Lahore
☐ Importer
Evidence of approval of manufacturing Firm has submitted copy of covering letter for renewal
facility of DML and approval letters of licensed sections.
☐ Export sale
TENDOL TABLET 50mg
name
Strength / concentration of drug of Each immediate release Film Coated tablet contains:
per unit

specifications
Proposed Pack size 10’s,20’s & 30’s (Alu-Alu Blister)
Proposed unit price Rs.500 for 10’s
Rs.1000 for 10’s
Rs.1500 for 30’s
authorities NUCYNTA 50mg (Tepentadol HCL) Tablet
For generic drugs (me-too status) Tapento Tablet 75 mg (M/s Sami Pharmaceuticals (Pvt)
Ltd, Karachi)
Registration No. 093064
India.

studies) conditions. The accelerated stability is conducted at
40oC ± 2oC / 75% ± 5% RH for 6 months and data is
provided for (batch no. TPT50040513, TPT50050513,
TPT50050513).
The real time stability data is conducted at 30oC ± 2oC /
65% ± 5% RH for 24 months. (TPT50111119,
TPT50121119, TPT50131119)
Pharmaceutical Equivalence and Pharmaceutical Equivalence study is not performed
Comparative Dissolution Profile against the innovator / Reference Product

Plaxodol Tablet 50mg (M/s Jenner Pharma,
Skeikhupura) instead of Innovator / Reference Product
of same strength.in Acid media (0.1N HCl), acetate
buffer pH 4.5 & Phosphate Buffer pH 6.8. The F2 values
are found satisfactory(>50%).
Description of Pack
system)
Batch No. Not Provided Not Provided Not
Provided
Batch Size Not Provided Not Provided Not
Provided
Manufacturing Not Provided Not Provided Not
Date Provided
Date of Initiation Not
Not Provided Not Provided
Provided
No. of Batches 03
the firm (if any)
import).
4. Data of stability batches will be Submitted. However needs to be evaluated in the
supported by attested respective light of date of initiation till completion of stability
etc.
testing
6. Record of Digital data logger for Submitted. However needs to be evaluated in the light
temperature and humidity monitoring of of date of initiation till completion of stability
accelerated)
Evaluation by PEC:
1. Provide copy of valid DML.
3. Pharmaceutical equivalence study and test results are not submitted against Innovator /
Reference Product of same strength For Tendol Tablets 100mg.
4. Comparative Dissolution Profile studies are performed for Tendol Tablets 75mg against
Tapento Tablet 75mg manufactured by (M/s Sami Pharmaceuticals (Pvt) Ltd, Karachi instead
of Innovator / Reference Product of same strength.
5. RSD is not calculated for Robustness test as performed during analytical method validation
of Drug Product.
6. Precision and accuracy test and test report in analytical method validation of Drug Product
are not submitted.
in its 293rd meeting including batch No, batch size, manufacturing date, date of initiation, API
lot No etc.
8. Documents for the procurement of API with approval from DRAP (in case of import) along
with COA of relevant batch needs to be submitted.
9. Batch manufacturing record for all batches prepared for stability testing needs to be provided
for all strengths.
Kaku, Lahore
☐ Importer
Evidence of approval of manufacturing Firm has not submitted copy of valid DML and
facility approval letters of licensed sections
☐ Export sale
TENDOL TABLET 100mg
name
Strength / concentration of drug of Each Film Coated immediate release tablet contains:
per unit

specifications
Proposed Pack size 10’s,20’s & 30’s Alu-Alu Blister
authorities NUCYNTA100mg (Tepentadol HCL) Tablet
For generic drugs (me-too status) Tapento Tablet 75mg (M/s Sami Pharmaceuticals (Pvt)
Ltd, Karachi)
The strength is different
India.
for 24 months.
Pharmaceutical Equivalence and Pharmaceutical Equivalence have been established
Comparative Dissolution Profile against the Tapento 75mg Tablets manufactured by
M/s Sami Pharmaceuticals (Pvt) Ltd, Karachi instead
of Innovator / Reference Product of same strength.

is Tapento 75mg Tablets manufactured by M/s Sami
Pharmaceuticals (Pvt) Ltd, Karachi instead of
Innovator / Reference Product of same strength.in
Acid media (0.1N HCl),
API Lot No. API lot No is mentioned generally as 40000290161 but the lot no of individual
API(s) is not mentioned.
Description of Pack
system)
Batch No. TL100-01 TL100-02 TL100-03
Batch Size 1000
TABLETS
Manufacturing
04-2021 04-2021 04-2021
Date
No. of Batches 03
the firm (if any)
import).
4. Data of stability batches will be Firm has submitted complete record of testing of all
supported by attested respective batches along with chromatograms, raw data sheets,
documents like chromatograms, Raw COA and summary data sheets.
etc.
testing
6. Record of Digital data logger for Submitted.
accelerated)
Evaluation by PEC:
1. Fee submitted is 30,000 therefore submit remaining 45,000 fee for new drug molecule.
2. Provide copy of valid DML along with approval letter of licensed sections.
3. The strength of Proposed Product is different from Tapento Tablet 75mg (M/s Sami
Pharmaceuticals (Pvt) Ltd, Karachi)
5. Pharmaceutical equivalence and CDP studies are performed against Tapento 75mg Tablets
manufactured by M/s Sami Pharmaceuticals (Pvt) Ltd, Karachi instead of Innovator /
Reference Product of same strength.
6. RSD is not calculated for Robustness , Precision in method validation test reports.
7. Test of accuracy is not performed in method validation of Product development.
in its 293rd meeting including batch No, batch size, manufacaturing date, date of initiation,
API lot No and storage conditions etc.
9. Documents for the procurement of API with approval from DRAP (in case of import).
shortcomings within six months
53. Name, address of Applicant / M/s Next Pharmaceutical Pvt. Ltd. Plot 44,A-B, Sundar
Marketing Authorization Holder Industrial Estate , Lahore
Name, address of Manufacturing site. M/s Next Pharmaceutical Pvt. Ltd. Plot 44,A-B, Sundar
Industrial Estate , Lahore
☐ Importer
GMP status of the drug product Firm has submitted copy of DML No. 000847
manufacturer (Formulation) valid till 25-10-2026.
facility DML No. 000847 (Formulation) on which Tablet
(General) section is mentioned as approved section.
☐ Export sale
Details of fee submitted PKR30000 dated: 15-10-2021 bearing Deposit Slip
No. 175588966019
Valvet-S 24/26 mg Film Coated Tablet
name
Active Pharmaceutical ingredient (API) Sacubitril … 24mg
per unit Valsartan ………………...… 26mg
(as sacubitril valsartan sodium salt complex)
Pharmacotherapeutic Group of (API) Valsartan : Angiotensin II Receptor Antagonist

Sacubitril : Neprilysin inhibitor
specifications
The status in reference regulatory Entresto 24 mg/26 mg film-coated tablets EMA (Europe)
authorities approved
For generic drugs (me-too status) 1. Savesto 50mg of M/s Getz Pharma (Pvt) Ltd,
Karachi.
2. Valsatril 50(24/26 mg) of M/s Sami
Pharmaceuticals (Pvt) Ltd, Karachi
Name and address of API manufacturer. Sacubitril-Valsartan Complex
Nantong Chanyoo Pharmatech Co., Ltd, China
LCZ696 In-House Specifications

for 06 months.
Comparative Dissolution Profile against the innovator that is Entresto Tablet 50mg by
Novartis Europharm Limited by performing quality tests
including Identification, water content, Assay,
Dissolution, Disintegration.

Entresto Tablet 50mg by Novartis Europharm Limited in
0.1N HCl (QC medium), Acid media (0.1N HCl), acetate
buffer pH 4.5 & Phosphate Buffer pH 6.8. The F2 values
are found satisfactory.
Manufacturer of Sacubitril-Valsartan Complex
API Nantong Chanyoo Pharmatech Co., Ltd, China
In-House Specifications
API Lot No. API Batch No. RD-LCZ696-202010101
Description of Pack
(Container closure The proposed pack size of Valvet- S Tablet 24/26mg is 1x14’s in Alu—Alu Blister.
system)
Frequency Accelerated: 0, 1,2,3,6 (Months)
Real Time: 0, 1,2,3, 6(Months)
Batch No. T0001-TAS T0002-TAS T0003-TAS
Batch Size 2000
TABLETS
Manufacturing
06-05-21 06-05-21 06-05-21
Date
No. of Batches 03
1. Reference of previous approval of Not Provided
the firm (if any)
2. Approval of API/ DML/GMP Nantong Chanyoo Pharmatech Co, Ltd,
certificate of API manufacturer issued Yangkou Chemical Industrial Park , Rundong Coastal
by concerned regulatory authority of Economic Development Zone, China.
country of origin. Manufacturing License No.Su 2016512
3. Documents for the procurement of API COA of Batch No. RD-LCZ696-202010101 of API
with approval from DRAP (in case of (Valsartan/Sacubitril) of both Drug Substance
import). manufacturer and Drug Product manufacturer is provided
etc.
testing
accelerated)
Evaluation by PEC:
1. Either Provide valid copy of DML No. 000847(Formulation) or proof of submission of
application in Licensing Division, DRAP.
2. Stability study of Product is of three months , therefore, provide six (06) months stability
data of Product.
3. Data Log of stability chambers reveals that the average of humidity was 57 % in Real
time stability study with minimum reading of 19.4.
4. Compatibility studies of the Drug Substance(s) with excipients shall be provided if the
qualitative composition of the formulation is not similar to innovator / reference product
5. API) lot no. is not provided in stability data sheet and neither the same is mentioned in batch
manufacturing.
6. COA of batch (Lot) of API of API manufacturer, Product manufacturer which is being used
in manufacturing of relevant batches of Final Product needs to be provided.
7. Clearance of relevant batch of API & of Standard from AD DRAP Lahore needs to be
provided.
Reply of the Applicant:
1. Firm has submitted copy of DML No. 000847 (Formulation) valid till 25-10-2026.
2. The stability studies data sheets are provided for six months, however, attested respective
documents like chromatograms, for each point of testing (0,1,3 months) respectively are not
submitted.
3. The firm has not submitted the Record of Digital data logger for temperature and humidity
monitoring of stability chambers (real time and accelerated) instead has provided the Disc for
said purpose which contains the said record.
4. The excipients used by the innovator Product Entresto 24mg/26mg are Microcrystalline cellulose,
low substituted hydroxypropylcellulose, crospovidone, magnesium stearate, talc, colloidal silicon
dioxide while the Product Manufacturer has used are similar.
5. COA of Batch No. RD-LCZ696-202010101 of API (Valsartan/Sacubitril) of both Drug
Substance manufacturer and Drug Product manufacturer is provided
6. Document dated 24-11-2020 for the procurement of API with approval from DRAP (in case of
import) Batch No. RD-LCZ696-202010101 of API (Valsartan/Sacubitril) is submitted.
Decision: Approved.
• Firm shall submit attested respective documents like chromatograms, for each time point of
stability studies, till 6th month time point, before issuance of registration letter.
throughout proposed shelf life and on accelerated studies for six months as per the commitment
54. Name, address of Applicant / M/s Getz Pharma (Pvt) Ltd, Plot No. 29-30, Sector
Marketing Authorization Holder 27,Korangi Industrial Area, Karachi.
Name, address of Manufacturing site. M/s Getz Pharma (Pvt) Ltd, Plot No. 29-30, Sector
27,Korangi Industrial Area, Karachi.
☐ Importer
Evidence of approval of manufacturing copy of Valid DML No. 000284 (Formulation) is
facility provided along with covering letter is provided.
☐ Export sale
Details of fee submitted PKR 30000 dated: 03-2022 .
SLIP No. 857472863756
The proposed proprietary name / brand DAPLYZA-M XR TABLET
name Dapagliflozin + Metformin HCL ( 5mg/1000mg)
Strength / concentration of drug of Each film coated XR tablet contains:
Active Pharmaceutical ingredient (API) Dapagliflozin … 5mg
per unit Metformin HCL … 1000 mg
Pharmacotherapeutic Group of (API) Anti-Diabetic

In-House Specs
specifications
Proposed Pack size 14’s & 28’s (Alu-Alu Blister in a unit carton)
The status in reference regulatory USFDA Approved (Xigduo XR 5mg/1000mg) Film
authorities coated extended release tablets by M/s Astra Zenica
USA.
For generic drugs (me-too status) Dapa-Met XR Tablets (5/1000 mg) by M/s Hilton
Pharma (Pvt) Ltd, Karachi.
Name and address of API manufacturer. Metformin HCL (USP):
M/s Shouguang Fukang Pharmaceutical Co., Ltd, North
East of Dongwaihuan Province, China.
Certificate No. SD20190888 valid till 12-03-2024.
Dapagliflozin :
Fuxin Long Rui Pharmaceutical Co., Ltd,
GMP Certificate valid till 23-08-2023
for 24 months.
Comparative Dissolution Profile against Dapa-Met XR Tablets (5mg + 1000mg) by M/s
Hilton Pharma (Pvt) Ltd, Karachi by performing quality
tests including Identification, water content, Assay,

(Dapa-Met XR Tablets (5mg + 1000mg) by M/s Hilton
Pharma (Pvt) Ltd, Karachi in .1N HCL, acetate buffer
pH 4.5 & Phosphate Buffer pH 6.8. The F2 values are
found satisfactory(>50%).
Manufacturer of Metformin HCL (USP):
API M/s Shouguang Fukang Pharmaceutical Co., Ltd, North East of Dongwaihuan
Province, China.
Dapagliflozin :
API Lot No. Metformin HCL :
API Lot No is 0000185425, 0186833
Dapagliflozin :
API Lot No. D02DG0605
Description of
Pack The proposed pack size of DAPLYZA-M XR TABLET
(Container closure is 14’s & 28’s (Alu-Alu Blister in unit carton)
system)
Batch No. 580DS01 580DS02 574DS03
Batch Size 1500
TABLETS
Manufacturing
14-4-2021 28-05-2021 28-05-2021
Date
No. of Batches 03
1. Reference of previous approval of Firm has referred to onsite inspection report of their
applications with stability study data of product for Estine Tablets 10mg & 20mg (Ebastine
the firm (if any) 10mg& 20mg) on 6th May 2019. Further, the said panel
inspection report was discussed in 289th Drug
Registration Board meeting held on 14th-16th May 2019.
The case was approved and the inspection report
• The HPLC software is 21CFR Compliant as per
record available with the firm.
•
Adequate monitoring and control are available for
alerts as well.
2. Approval of API/ DML/GMP Metformin HCL (USP):
certificate of API manufacturer issued M/s Shouguang Fukang Pharmaceutical Co., Ltd, North
by concerned regulatory authority of East of Dongwaihuan Province, China.
country of origin. Certificate No. SD20190888 valid till 12-03-2024.
Dapagliflozin Propionate:
3. Documents for the procurement of API
with approval from DRAP (in case of Dapagliflozin Propanediol :
import). Commercial Invoice No. HN200109-F
Dated 16-01-2020
Metformin-HCL :
The invoice of relevant batch 0187504 used in Product
Development is provided.
etc.
testing
accelerated)
Evaluation by PEC:
Observations :
1. Documents for the procurement of API with approval from DRAP (in case of import) for relevant
batch (0000-185425 & 0-186833 )of API Metformin-HCL used in Product Development is
not provided.
2. CDP has been performed against the same brand that is (Dapa-Met XR Tablets (5mg + 1000mg)
by M/s Hilton Pharma (Pvt) Ltd, Karachi in .1N HCL, acetate buffer pH 4.5 & Phosphate Buffer
pH 6.8 istead of innovator that is (Xigduo XR 5mg/1000mg) Film coated extended release tablets
by M/s Astra Zenica USA.
Response of the firm :
Query Items Response
1.Documents for the Please refer to Annex-1 for documents for the
procurement of relevant batch procurement of API with approval from DRAP for
(0000-185425 & 0-186833) of relevant batches (0000-185425 & 0-186833) of API
Metformin HCl API with Metformin HCl.
approval from DRAP along
with COA of said batches as
provided by Drug Substance
manufacturer and Drug API API Batch No. Invoice No. DRAP
product manufacturer. Batch M/s Approval
No. Shouguang Date
(Getz Fukang
Pharma) Pharmaceutical
Co., Ltd.
0000- A- JC202008013- 03-12-
185425 81412010085 1 2020
0000- A- JC202008014- 05-01-
186833 22612012009- 1 2021
0150
2.Please clarify why the This is to bring to your kind information that as per DRAP
comparative dissolution guidelines “Guidance document for submission of
studies are performed with application on Form 5-F (CTD) for registration of
DAPA-Met XR 5mg + 500mg pharmaceutical Drug products for human use”, to perform
by M/s Hilton Pharma (Pvt) Pharmaceutical Equivalence ‘The comparison of the
Ltd, Karachi instead of developed formulation and the innovator / reference /
reference product USFDA comparator product including the results of all the quality
Approved Xigduo XR 5mg + tests shall be submitted and discussed’.
500mg Film coated extended We have established Pharmaceutical Equivalence of
release tablets. Daplyza-M XR Tablets 5mg + 500mg (manufactured by
Getz Pharma) with Dapa-Met XR Tablets 5mg + 500mg
Manufactured by M/s Hilton Pharma (Pvt.) Limite as
innovator brand is currently not available in Pakistan.
3.Provide Pharmaceutical Please refer to Point #02 of this letter.
equivalence study and test
results of both Daplyza Tablets
and reference product USFDA
approved Xigduo XR 5mg +
500mg Film coated extended
release tablets.
Decision: Approved with Innovator’s specifications.
☐ Importer
☐ Export sale
Active Pharmaceutical ingredient (API) Dapagliflozin … 5 mg

In-House Specs
specifications
Proposed Pack size 14’s & 28’s
authorities coated extended release tablets
For generic drugs (me-too status) New Drug
Dapagliflozin :
for 24 months.
Comparative Dissolution Profile against the Dapa-Met XR 5mg/500mg by M/s Hilton
Pharma (Pvt) Ltd , Karachi by performing quality tests

(Dapa-Met XR 5mg/500mg by M/s Hilton Pharma (Pvt)
Ltd , Karachi in Acid media (0.1N HCl), acetate buffer
Province, China.
Dapagliflozin :
API Lot No is 0187504
Dapagliflozin :
Description of
(Container closure is 14’s & 28’s
system)
Batch No. 581DS02 581DS03 581DS04
Batch Size 1500
TABLETS
Manufacturing
15-06-2021 07-07-2021 07-07-2021
Date
No. of Batches 03
alerts as well.
Dated 16-01-2020
Metformin-HCL :
Development is not provided.
etc.
testing
accelerated)
Evaluation by PEC:
1. Documents for the procurement of relevant batch (0000-185425 & 0-186833) of Metformin-
HCL API with approval from DRAP.
2. Please clarify since the UV method is used in dissolution testing of drug product for Metformin
HCl while the assay of Metformin HCl is performed on HPLC as per supplier’s method.
3. Test Protocols for method validation of Dapagliflozin (drug substance) needs to be provided
along with detail of test results for Accuracy of analytical method validation performed by drug
4. The record of digital data logger of stability chambers (accelerated and real time) throughout the
6 months for which stability study data has been submitted, since your submission does not
contain complete record of data logger.
Response/Reply of firm:

1. Documents for the Please refer to Annex -1 for documents for the procurement of API
procurement of relevant batch with approval from DRAP for relevant batches (0000-185425 &
(0000-185425 & 0-186833) of 0-186833) of API Metformin HCl.
Metformin HCL API with
approval from DRAP. API API Batch No. Invoice No. DRAP
Batch M/s Shouguang Approval
No. Fukang Date
(Getz Pharmaceutical Co.,
Pharma) Ltd.
0000- A-81412010085 JC202008013- 03-12-
185425 1 2020
0000- A-22612012009- JC202008014- 05-01-
186833 0150 1 2021
2.Please clarify since the UV This is bring to your kind attention that as per US-FDA,
method is used in dissolution Dissolution medium for Dapagliflozin + Metformin Extended
testing of drug product for Release Tablet is phosphate buffer Ph 6.8.During HPLC testing,
Metformin HCl while the peak of dissolution medium can merged with peak of Metformin
assay of Metformin HCl is HCl and lead to inaccurate results. Therefore, we have developed
performed on HPLC as per UV method for dissolution for Metformin HCl to get the accurate
supplier’s method. quantitation results.
Further, USP monographs for Metformin HCl extended release
tablets used Spectrophotometric determination for dissolution of
Metformin HCl whereas its assay is on HPLC.
3.Test Protocols for method Please refer to Annex-2 for Test Protocols for method validation
validation of Dapagliflozin of Dapagliflozin (drug substance) including specificity, linearity,
(drug substance) needs to be repeatability and range by drug product manufacturer.
provided along with detail of Further, with reference to ICH Guidelines “VALIDATION OF
test results for Accuracy of ANALYTICAL PROCEDURES: TEXT AND
analytical method validation METHODOLOGY Q2 (R1)” it is mentioned in section 4.1.1 Drug
performed by drug product Substance “accuracy may be inferred once precision, linearity and
manufacturer. specificity have been established”.
This is bring to your kind attention that since we have performed
method verification studies as per ICH Q2 (R1) therefore,
requirement of accuracy is not applicable.
4.The record of digital data Please refer to Annex -3 for record of digital data logger of
logger of stability chambers stability chambers (Accelerated & Real time) throughout the 06
(Accelerated & Real time) months for which stability data has been submitted.
throughout the 06 months for
which stability data has been
submitted, since your
submission does not contain
complete record of data logger.
☐ Importer
☐ Export sale
SLIP No. 987829781
name Dapagliflozin + Metformin HCL ( 2.5mg/1000mg)
Active Pharmaceutical ingredient (API) Dapagliflozin … 2.5 mg
In-House Specs
specifications
The status in reference regulatory USFDA Approved (Xigduo XR 2.5mg/1000mg) Film
authorities coated extended release tablets by M/s Astra Zenica
USA.
For generic drugs (me-too status) Dapa-Met XR Tablets (2.5/1000 mg) by M/s Hilton
Pharma (Pvt) Ltd, Karachi.
Dapagliflozin :
for 24 months.
Comparative Dissolution Profile against Dapa-Met XR Tablets (2.5mg + 1000mg) by M/s
Hilton Pharma (Pvt) Ltd, Karachi by performing quality
tests including Identification, water content, Assay,

(Dapa-Met XR Tablets (2.5mg + 1000mg) by M/s Hilton
Pharma (Pvt) Ltd, Karachi in .1N HCL, acetate buffer
Province, China.
Dapagliflozin :
API Lot No is 0000185425, 0186833
Dapagliflozin :
Description of
system)
Batch No. 574DS01 574DS02 574DS03
Batch Size 1500
TABLETS
Manufacturing
14-4-2021 08-07-2021 28-05-2021
Date
No. of Batches 03
alerts as well.
Dated 16-01-2020
Metformin-HCL :
etc.
testing
accelerated)
Evaluation by PEC:
Observations :
HCL API with approval from DRAP along with COA of said batches as provided by Drug
Substance manufacturer and Drug Product manufacturer.
2. Please clarify why the comparative dissolution studies are performed with (Dapa-Met XR
5mg/500mg by M/s Hilton Pharma (Pvt) Ltd , Karachi instead of reference Product USFDA
Approved Xigduo XR 5mg/500mg) Film coated extended release tablets.
3. Provide Pharmaceutical equivalence study and test results of both DAPLYZA Tablets and of
reference Product USFDA Approved Xigduo XR 5mg/500mg) Film coated extended release
tablets.
Reply of the Firm :
1. Documents for the Please refer to Annex-1 for documents for the
procurement of relevant batch procurement of API with approval from DRAP for
(0000-185425 & 0-186833) of relevant batches (0000-185425 & 0-186833) of API
Metformin HCl API with Metformin HCl.
approval from DRAP along
with COA of said batches as API API Batch No. Invoice No. DRAP
provided by Drug Substance Batch M/s Approval
manufacturer and Drug product No. Shouguang Date
manufacturer. (Getz Fukang
Pharma) Pharmaceutical
Co., Ltd.
0000- A- JC202008013- 03-12-
185425 81412010085 1 2020
0000- A- JC202008014- 05-01-
186833 22612012009- 1 2021
0150
release tablets.
☐ Importer
☐ Export sale

In-House Specs
specifications
For generic drugs (me-too status) New Drug
Dapagliflozin :
for 24 months.
Comparative Dissolution Profile against the brand leader Xigduo XR 10mg/500mg by
M/s Astra Zenica USA), by performing quality tests

(Xigduo XR 10mg/500mg by M/s Astra Zenica USA in
Acid media (0.1N HCl), acetate buffer pH 4.5 &
Phosphate Buffer pH 6.8. The F2 values are found
satisfactory(>50%).
Province, China.
Dapagliflozin :
Dapagliflozin :
Description of
system)
Batch No. 582DS02 582DS03 582DS04
Batch Size 1500
TABLETS
Manufacturing
08-07-2021 08-07-2021 08-07-2021
Date
No. of Batches 03
alerts as well.
Dated 16-01-2020
Metformin-HCL :
etc.
testing
accelerated)
Observations :
HCL API with approval from DRAP along with COA of said batches as provided by Drug
Substance manufacturer and Drug Product manufacturer.
2. Please clarify why the comparative dissolution studies are performed with (Dapa-Met XR
5mg/500mg by M/s Hilton Pharma (Pvt) Ltd , Karachi instead of reference Product USFDA
Approved Xigduo XR 5mg/500mg) Film coated extended release tablets.
3. Provide Pharmaceutical equivalence study and test results of both DAPLYZA Tablets and of
reference Product USFDA Approved Xigduo XR 5mg/500mg)
1. Documents for the Please refer to Annex-1 for documents for the
procurement of procurement of API with approval from DRAP for
relevant batch (0000- relevant batches (0000-185425 & 0-186833) of API
185425 & 0-186833) Metformin HCl.
of Metformin HCl
API with approval API API Batch No. Invoice No. DRAP
from DRAP along Batch M/s Approval
with COA of said No. Shouguang Date
batches as provided (Getz Fukang
by Drug Substance Pharma) Pharmaceutical
manufacturer and Co., Ltd.
Drug product 0000- A- JC202008013- 03-12-
manufacturer. 185425 81412010085 1 2020
0000- A- JC202008014- 05-01-
186833 22612012009- 1 2021
0150
release tablets.
☐ Importer
☐ Export sale
name Dapagliflozin + Metformin HCL ( 10mg/1000 mg)
USP Specs.

In-House Specs
specifications
Proposed Pack size 14’s & 28’s Tablets
For generic drugs (me-too status) Dapa-Met XR Tablets (10mg + 1000mg)
M/s Hilton Pharma (Pvt) Ltd, Karachi
Dapagliflozin :
for 24 months.
Comparative Dissolution Profile against the brand leader that Rama-D Tablet
manufactured by M/s Global Pharma, Islamabad), by
performing quality tests including Identification, water
content, Assay, Dissolution, Disintegration.

Rama-D Tablet 37.5mg/325 mg by M/s Global Pharma
Islamabad in Acid media (0.1N HCl), acetate buffer pH
4.5 & Phosphate Buffer pH 6.8. The F2 values are found
satisfactory(>50%).
Province, China.
Dapagliflozin :
Dapagliflozin :
Description of
system)
Batch No. 575DS01 575DS02 575DS03
Batch Size 1500
TABLETS
Manufacturing
14-04-2021 28-05-2021 08-2019
Date
Date of Initiation 10-08-2021 10-08-2021 08-2019
No. of Batches 03
alerts as well.
Dated 16-01-2020
Metformin-HCL :
The invoice of relevant batch 0000185425 used in
Product Development is not provided.
etc.
testing
accelerated)
Evaluation by PEC:
Observations :
HCL API with approval from DRAP.
2. Please clarify since the UV method is used in dissolution testing of drug product for Metformin
HCl while the assay of Metformin HCl is performed on HPLC as per supplier’s method.
3. Test Protocols for method validation of Dapagliflozin (drug substance) needs to be provided
along with detail of test results for Accuracy of analytical method validation performed by drug
4. The record of digital data logger of stability chambers (accelerated and real time) throughout the
6 months for which stability study data has been submitted, since your submission does not
contain complete record of data logger.
Reply of the firm :
1. Documents for the Please refer to Annex -1 for documents for the procurement
procurement of relevant of API with approval from DRAP for relevant batches
batch (0000-185425 & 0- (0000-185425 & 0-186833) of API Metformin HCl.
186833) of Metformin HCL
API with approval from API API Batch No. Invoice No. DRAP
DRAP. Batch M/s Shouguang Approval
No. Fukang Date
(Getz Pharmaceutical
Pharma) Co., Ltd.
0000- A-81412010085 JC202008013- 03-12-
185425 1 2020
0000- A- JC202008014- 05-01-
186833 22612012009- 1 2021
0150
2.Please clarify since the UV method is This is bring to your kind attention that as per US-FDA,
used in dissolution testing of drug Dissolution medium for Dapagliflozin + Metformin
product for Metformin HCl while the Extended Release Tablet is phosphate buffer Ph 6.8.During
assay of Metformin HCl is performed HPLC testing, peak of dissolution medium can merged
on HPLC as per supplier’s method. with peak of Metformin HCl and lead to inaccurate results.
Therefore, we have developed UV method for dissolution
for Metformin HCl to get the accurate quantitation results.
Further, USP monographs for Metformin HCl extended

release tablets used Spectrophotometric determination for
dissolution of Metformin HCl whereas its assay is on
HPLC.
3.Test Protocols for method validation Please refer to Annex-2 for Test Protocols for method
of Dapagliflozin (drug substance) validation of Dapagliflozin (drug substance) including
needs to be provided along with detail specificity, linearity, repeatability and range by drug
of test results for Accuracy of product manufacturer.
analytical method validation
performed by drug product Further, with reference to ICH Guidelines “VALIDATION
manufacturer. OF ANALYTICAL PROCEDURES: TEXT AND
METHODOLOGY Q2 (R1)” it is mentioned in section
4.1.1 Drug Substance “accuracy may be inferred once
precision, linearity and specificity have been established”.
This is bring to your kind attention that since we have

performed method verification studies as per ICH Q2 (R1)
therefore, requirement of accuracy is not applicable.
Link of ICH guideline is provided below:
Q2(R1) Guideline.pdf (ich.org)

4.The record of digital data logger of Please refer to Annex -3 for record of digital data logger of
stability chambers (Accelerated & stability chambers (Accelerated & Real time) throughout
Real time) throughout the 06 months the 06 months for which stability data has been submitted.
for which stability data has been
submitted, since your submission
does not contain complete record of
data logger.
3. Cases of New Sections :

59. Name, address of Applicant / M/s Biogen Life Sciences
Marketing Authorization Holder 8 km Chakbeli Road Rawat Rawalpindi
Name, address of Manufacturing site. M/s Biogen Life Sciences
8 km Chakbeli Road Rawat Rawalpindi
☐ Importer
Evidence of approval of manufacturing copy of Valid DML No. 000911 (Formulation) valid till
facility 13-02-2025 along with covering letter is provided.
☐ Export sale
SLIP No. 9108432875
Actogen 100ml Vial
name
Strength / concentration of drug of
Active Pharmaceutical ingredient Each Vial contains:
(API) per unit Paracetamol 10mg/ml solution for infusion
Pharmaceutical form of applied drug
Solution for Infusion
Pharmacotherapeutic Group of (API) Anti-Pyretic
Innovator Specs
specifications
USFDA Approved
authorities
For generic drugs (me-too status) Brand Name: Provas (10mg/ml)
Registration holder: M/s Sami Pharmaceuticals (Pvt)
Ltd, Karachi.
Registration Number: 050650
Name and address of API manufacturer. M/s Citi Pharma (Pvt) Ltd, 3 km, Head Balloki Road,
Phool Nagar, Kasur.
GMP Certificate No. 10444/2016-DRAP/2016
Firm has summarized information related to
batch analysis and justification of specification, reference
standard, container closure system and stability studies of
drug substance.
for 24 months.
process validation protocols, control of excipients,
control of drug product, specifications, analytical
procedures, validation of analytical procedures, batch
analysis, justification of specifications, reference
standard or materials, container closure system and
stability.
Pharmaceutical Equivalence and Pharmaceutical Equivalence have not been
Comparative Dissolution Profile established/submitted with innovator Product, but with
Provas Infusion of M/s Sami Pharmaceuticals (Pvt) Ltd,
Karachi
Analytical method Firm has submitted report of verification studies of
Firm has submitted report of validation of analytical
method (In-House) for the drug product.
Manufacturer of API M/s Citi Pharma (Pvt) Ltd, 3 km, Head Balloki Road, Phool Nagar, Kasur.
GMP Certificate No. 10444/2016-DRAP/2016
Description of Pack 1’s

(Container closure
system)
No. of Batches 03
1. Reference of previous approval of • Not Submitted.
applications with stability study data of • Firm has stated that Biogen is a new license section
the firm (if any) and no such data is submitted
2. Approval of API/ DML/GMP certificate Sun Pharmaceutical Industries Limited, Industrial Area -
of API manufacturer issued by concerned 3 A.B. Road 455001 Madhya Pradesh , India
regulatory authority of country of origin. DML No. 24/24/83 in form no. 25 & 28/15/83 in form
no.28
3. Documents for the procurement of API Not required.
with approval from DRAP (in case of
import).
etc.
testing
accelerated)
Evaluation by PEC :
1. Provide updated GMP certificate of API manufacturer M/s Citi Pharma Kasur as the
submitted GMP certificated is dated 2016.
2. API manufacturer (M/s citi Pharma Kasur) has performed melting point test for
identification of API but has set specifications different from those as mentioned in BP.
3. API manufacturer (M/s citi Pharma Kasur) has performed impurities testing as mentioned
in BP but the acceptance criteria is kept at Not more than 1 % while the one mentioned in
BP is max .2%
4. Provide the detailed analytical method with complete detail (method verification) along
with test reports of API as performed by the Drug Product manufacturer.
5. The Manufacturing Protocol/Procedure for manufacture/Product Development (including
sterility testing ) are not submitted.
6. Batch detail along with BMR (including sterility testing) is not provided for
manufacturing of Drug Product.
7. Compliance Record of HPLC software 21CFR & audit trail reports on product testing is
not Provided.
8. Submit microbial reports for the sterility testing of drug product along during stability
studies.
9. Pharmaceutical Equivalence studies along with test reports results of all the quality tests
(mentioned in any official pharmacopoeia or section 3.2.P.5.1 of this application) of the
developed formulation and the innovator / reference / comparator product shall be
submitted with innovator Product of Drug Product are not submitted.
11. Provide compatibility study protocol along with reports as the excipients being used are
different from the ones mentioned/used in innovator Product (USFDA)
12. In chromatogram of stability studies, study on blank and respective chromatogram of
blank is not submitted.
13. Compliance Record of HPLC software 21CFR & audit trail reports on product testing
needs to be submitted.
14. Record of Digital data logger for temperature and humidity monitoring of stability
chambers (real time and accelerated) is not submitted.
☐ Importer
facility 13-02-2025 is provided along with covering letter is
provided.
☐ Export sale
SLIP No. 9829497909
The proposed proprietary name / brand Cilagen 250mg Injection IV
name (Powder for injection/infusion)
(API) per unit Imipenem (as Monohydrate)---------250mg
Cilastatin (as Sodium)---------250mg
Powder for solution for injection/infusion
Pharmacotherapeutic Group of (API) Anti-Biotics (Anti Bacterial)
USP Specs
specifications
Proposed Pack size As per SRO
Innovator Product (MHRA) :
Pack sizes: 1 x 250 mg vial 10 x 250 mg vial Not all
pack sizes may be marketed.
MHRA Approved
authorities
For generic drugs (me-too status) Brand Name: Cilapen 250mg Injection
Registration holder: Bosh pharmaceuticals
Name and address of API manufacturer. Sun Pharmaceutical Industries Limited, Industrial Area -
3 A.B. Road 455001 Madhya Pradesh , India
GMP Certificate No. V/WHOGMP/Rev/Sun-17/2019
drug substance.
for 24 months.
stability.
Pharmaceutical Equivalence and Pharmaceutical Equivalence have been not been
Comparative Dissolution Profile established/submitted.
Analytical method Not Submitted.
validation/verification of product
Manufacturer of API Sun Pharmaceutical Industries Limited, Industrial Area -3 A.B. Road 455001
Madhya Pradesh , India
GMP Certificate No. V/WHOGMP/Rev/Sun-17/2019 valid till 02-10-2022
API Lot No. Imipenem Monohydrate & Cilastatin Sodium:
API Lot No is AB06493
Description of Pack
(Container closure As per SRO
system)
Batch No. 001 002 003
No. of Batches 03
applications with stability study data of • Firm has stated that Biogen is a new license facility
no.28
3. Documents for the procurement of API The invoice of relevant batch AB06493 used in
with approval from DRAP (in case of Product Development is not provided.
import).
etc.
testing
accelerated)
Evaluation by PEC:
1. Provide the analytical method with complete detail as the submitted documents contain
,issing/cutting along with test reports of API as performed by the Drug Substance
manufacturer.
2. Provide the analytical method with complete detail along with test reports of API as
performed by the Drug Product manufacturer.
3. The Manufacturing Protocol/Procedure for manufacture/Product Development are not
submitted.
4. Batch detail along with BMR is not provided for manufacturing of Drug Product.
5. Documents for the procurement of API with approval from DRAP of relevant batch
AB06493 used in Product Development is not provided.
6. Compliance Record of HPLC software 21CFR & audit trail reports on product testing is
not Provided.
8. Pharmaceutical Equivalence studies along with test reports are not submitted.
9. Provide supportive data i.e. attested respective documents like chromatograms specifying
whether of standard or sample etc, Raw data sheets, COA, summary data sheets etc.
☐ Importer
facility 13-02-2025 is provided along with covering letter is
provided.
☐ Export sale
SLIP No. 63961987615
The proposed proprietary name / brand Cilagen 500mg Injection IV
name (Powder for injection/infusion)
(API) per unit Imipenem (as Monohydrate)---------500mg
Cilastatin (as Sodium)---------500mg
Powder for solution for injection/infusion
Pharmacotherapeutic Group of (API) Anti-Biotics (Anti Bacterial)
USP Specs
specifications
Innovator Product (MHRA) :
Pack sizes: 1 x 250 mg vial 10 x 250 mg vial Not all
pack sizes may be marketed.
authorities (Primaxin Injection 500mg), Merck Inc USA.
For generic drugs (me-too status) Brand Name: Cilapen 500mg Injection
Registration holder: Bosh pharmaceuticals
Name and address of API manufacturer. Sun Pharmaceutical Industries Limited, Industrial Area -
3 A.B. Road 455001 Madhya Pradesh , India
GMP Certificate No. V/WHOGMP/Rev/Sun-17/2019
drug substance.
for 24 months.
stability.
Pharmaceutical Equivalence and Pharmaceutical Equivalence have been not been
Comparative Dissolution Profile established/submitted.
Analytical method Not Submitted.
Manufacturer of API Sun Pharmaceutical Industries Limited, Industrial Area -3 A.B. Road 455001
Madhya Pradesh , India
GMP Certificate No. V/WHOGMP/Rev/Sun-17/2019 valid till 02-10-2022
API Lot No. Imipenem Monohydrate & Cilastatin Sodium:
API Lot No is AB06493
Description of Pack
(Container closure As per SRO
system)
Batch No. 004 005 006
No. of Batches 03
applications with stability study data of • Firm has stated that Biogen is a new license facility
no.28
3. Documents for the procurement of API The invoice of relevant batch AB06493 used in
with approval from DRAP (in case of Product Development is not provided.
import).
etc.
testing
accelerated)
Evaluation by PEC:
1. Pack size of Drug Product is not submitted.
2. Provide the analytical method with complete detail as the submitted documents contain,
missing/cutting along with test reports of API as performed by the Drug Substance manufacturer.
3. Provide the analytical method with complete detail along with test reports of API as performed
by the Drug Product manufacturer.
4. The Manufacturing Protocol/Procedure for manufacture/Product Development are not submitted.
5. Batch detail along with BMR is not provided for manufacturing of Drug Product.
6. Stability data along with data sheets of three batches of API as performed by the API
manufacturer needs to be submitted.
7. Documents for the procurement of API with approval from DRAP of relevant batch AB06493
used in Product Development is not provided.
8. Compliance Record of HPLC software 21CFR & audit trail reports on product testing is not
Provided.
9. Submit microbial reports for the sterility testing of drug product along during stability studies.
10. Pharmaceutical Equivalence studies along with test reports of Drug Product with innovator
Product are not submitted.
11. Provide supportive data i.e. attested respective documents like chromatograms, Raw data sheets,
COA, summary data sheets etc.
12. Detail of equipment/machinery needs to be submitted.
13. The chromatograms of HPLC submitted along with stability data sheets do not specify the analyte
(whether standard , sample etc).
4. DEFFERED CASE:
62. Name, address of Applicant / M/s Pharmadic Laboratories (Pvt) Ltd, 16 KM, Multan
Marketing Authorization Holder Road, Lahore
Name, address of Manufacturing site. M/s Pharmadic Laboratories (Pvt) Ltd, 16 KM, Multan
Road, Lahore
☐ Importer
GMP status of the drug product Firm has submitted copy of GMP certificate No. 93/2020-
manufacturer DRAP(AD-2003099-790) dated 09-06-2020
Evidence of approval of manufacturing Tablet General Section
facility
☐ Export sale
Details of fee submitted PKR30000 dated: 27.05.2022 bearing Deposit Slip
No. 09713095356
The proposed proprietary name / brand Darvin Forte 75mg/650mg
name
Active Pharmaceutical ingredient Tramadol HCL … 75mg
(API) per unit Paracetamol ….. 650mg
Pharmacotherapeutic Group of (API) Opioid & Non-Opioid Analgesic

specifications
Proposed Pack size 1x 10’s (Alu-PVC Blisters)
The status in reference regulatory CLANDERON 75 mg / 650 mg , Aristo Pharma Iberia,
authorities Madrid Spain.
For generic drugs (me-too status) Tonoflex-P Forte (film coated) of M/s Sami
Pharmaceuticals (Pvt) Ltd, Karachi
Name and address of API manufacturer. Paracetamol (USP/BP):
M/s Saakh Pharma (Pvt) Ltd, Karachi.
GMP Certificate No. 83/2020-DRAP(K) dated 23-06-
2022
Tramadol HCL USP :

M/s S.L.R. Pharma (Pvt) Limited, Situated at Plot No. A-
69, API Estate Settipalli Post, Tirupati, Chittor District,
Andhra Pradesh, India.
License Retention Certificate dated 05-12-2019.
drug substance.
studies)
conditions. The accelerated stability data is conducted at
40oC ± 2oC / 75% ± 5% RH for 6 months.
The real time stability data is conducted at 30oC ± 2oC /
65% ± 5% RH for 24 months for both API’s namely
Paracetamol & Tramadol HCL USP .
stability.
Comparative Dissolution Profile against the Tonoflex-P Forte Tablet 75/650 mg by M/s
Sami Pharmaceuticals (Pvt) Ltd, Karachi by performing
quality tests including Identification, water content,
Assay, Dissolution, Disintegration.

Tonoflex-P Forte Tablet 75/650 mg by M/s Sami
Pharmaceuticals (Pvt) Ltd, Karachi in Acid media (0.1N
HCl), acetate buffer pH 4.5 & Phosphate Buffer pH 6.8.
The F2 values are not found satisfactory.
Manufacturer of API Paracetamol (BP):
M/s Saakh Pharma (Pvt) Ltd, Karachi.
GMP Certificate No. 83/2020-DRAP(K) dated 23-06-2022
Tramadol HCL USP :

M/s S.L.R. Pharma (Pvt) Limited, Situated at Plot No. A-69, API Estate
Settipalli Post, Tirupati, Chittor District, Andhra Pradesh, India.
API Lot No. Paracetamol : ZPAR18-143

Tramadol HCL : TDH0480218
Description of Pack
(Container closure The proposed pack size of Darvin Forte Tablet is 1x10’s in Alu—PVC Blister.
system)
Real Time: 0, 3, 6,9,12,18,24(Months)
Batch No. ACTD-TR001 ACTD-TR002 ACTD-TR003
Manufacturing Date 10,2019 10,2019 10,2019
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate Paracetamol (USP/BP):
of API manufacturer issued by concerned M/s Saakh Pharma (Pvt) Ltd, Karachi.
regulatory authority of country of origin. GMP Certificate No. 83/2020-DRAP(K) dated 23-06-
2022
Tramadol HCL USP :

M/s S.L.R. Pharma (Pvt) Limited, Situated at Plot No. A-
69, API Estate Settipalli Post, Tirupati, Chittor District,
Andhra Pradesh, India.
3. Documents for the procurement of API Paracetamol (BP):

with approval from DRAP (in case of Not Required
import). Tramadol HCL USP :
Not Provided
etc.
testing
6. Record of Digital data logger for Not Provided.
accelerated)
Evaluation by PEC:
1. Evidence of approval of applied formulation in reference regulatory authorities as defined by the
registration Board shall be submitted. As the applied formulation in reference regulatory
authorities is approved as “uncoated” tablets while the applicant has applied as film coated tablets
Decision: Since the applied product is approved as “uncoated tablet” in reference regulatory authorities
while the applicant has applied for film coated tablet. Therefore, Registration Board decided to defer the
case for evidence of approval of applied formulation in reference regulatory authorities/agencies a
“film coated tablet” which were declared/approved by the Registration Board in its 275th meeting.
Reply of the firm :
1. Provide certificate of analysis of relevant batch(es) of Drug Substance(s) (Paracetamol &
Tramadol HCL ) used in product development ( By both Drug Substance and Drug Product
manufacturer.
2. The Pharmaceutical equivalence studies and comparative dissolution Profile studies are not
conducted with the innovator Product.
3. Documents for the procurement of API with approval from DRAP (in case of import) of DS
Tramadol HCL USP :
4. As per submitted data of comparative dissolution profile following points have been observed:
• For Paracetamol:
➢ Value of F2 factor is 46% in Buffer Acetate pH 4.5
➢ Value of F2 factor is 38% in Phosphate Buffer pH 6.8
• For Tramadol HCl:
➢ value of F2 factor is 44% in 0.1N HCL
➢ Value of F2 factor is 46% in Phosphate buffer pH 6.8
Please justify scientifically.
5. Specificity testing in Analytical method validation has not been performed for the applied
Product.
6. Analytical Method for related substances /impurities testing of DS Paracetamol (BP) the HPLC
testing procedure/chromatographic conditions are different from the one as specified in BP.
7. DS manufacturer of Paracetamol has followed analytical method for testing(Assay) of API of BP
while the Drug Product manufacturer has tested by USP Specs. (The analytical method by DS
manufacturer is mentioned as BP but on COA of DS Assay is mentioned as USP)
8. The excipients being used are different from the ones used in Product Development of
Innovator/Reference Product , therefore, provide compatibility studies protocol/method along
with results.
Item No. III: Agenda of Evaluator-XI (Dr. Farhadullah)
Case No. 01: Routine Cases for registration of Human Drugs on Form 5F (Local)
63. Name, address of Applicant / Marketing M/s Shaigan Pharmaceuticals (Pvt.) Ltd., 14-Km
Authorization Holder Adyala Road, Post office Dahgal, Rawalpindi.
Name, address of Manufacturing site. M/s Shaigan Pharmaceuticals (Pvt.) Ltd., 14-Km
Adyala Road, Post office Dahgal, Rawalpindi.
☐ Importer
☐ Export sale
(Slip#6694987381)
The proposed proprietary name / brand Zedron oral solution
name
Strength / concentration of drug of Active Each 5ml contains:
Pharmaceutical ingredient (API) per unit Ondansetron…….. 4mg.
(As Ondansetron Hydrochloride Dihydrate)
Pharmaceutical form of applied drug Oral solution
Pharmacotherapeutic Group of (API) Serotonin 5HT3 antagonist. (Anti-emetic)
Reference to Finished product USP Specifications.
specifications
Proposed Pack size 25ml & 50ml
Proposed unit price As per S.R.O
The status in reference regulatory ZOFRAN (4mg/5ml) oral solution USFDA Approved
authorities
For generic drugs (me-too status) Onseron syrup by M/s Indus Pharma (Reg#058677)
GMP status of the Finished product GMP certificate issued to the firm on 28-08-2020
manufacturer based on inspection conducted on 25-09-2019.
Name and address of API manufacturer. CTX Lifesciences Pvt. Ltd., Block No: 251-252,
Sachin- Magdalla Road GIDC, Sachin, Surat – 394
230 GUJARAT, INDIA
solubilities, physical form, manufacturers, impurities,
product.
Module III (Drug Substance) Firm has submitted detailed data for drug substance
properties, solubilities, physical form, manufacturers,
impurities, analytical procedures verification, batch
standard, container closure system and stability studies
of drug substance.
Stability studies Firm has submitted stability study data of 3 batches of
drug substance at both accelerated as well as real time
conditions. The accelerated stability data is conducted
at 40°C ± 2°C / 75% ± 5% RH for 6 months. The real
time stability data is conducted at 25°C ± 2°C / 60 ±
5% RH for 60 months.
Batches; ON130001, ON130002, ON130003
Module-III (Drug Product): Firm has submitted data of drug product including its
description, composition, pharmaceutical
development, manufacture, manufacturing process
and process control, process validation protocols,
control of excipients, control of drug product,
specifications, analytical procedures, validation of
analytical procedures, batch analysis, justification of
specifications, reference standard or materials,
container closure system and stability.
comparative dissolution profile against the brand that is Onseron 4mg/5ml syrup by
M/s Indus Pharma (Pvt.) Ltd by performing quality
tests (description, Identification, pH, Assay).
Analytical method validation/verification Firm have submitted Method verification studies
Manufacturer of API CTX Lifesciences Pvt. Ltd., Block No: 251-252, Sachin- Magdalla Road
GIDC, Sachin, Surat – 394 230 GUJARAT, INDIA
API Lot No. 20ON00040
Description of Pack Amber color Plastic Bottle
Batch No. T-001 T-002 T-0003
Batch Size 500 bottles 500 bottles 500 bottles
No. of Batches 03
1. Reference of previous approval of The firm has referred to previous inspection for
applications with stability study data of the authenticity of stability data of their product by the
firm (if any) panel on the basis of which Registration Board in 297th
meeting dated 12-15th January 2021 decided to approve
registration of Emdagan 10mg & 25mg Tablets.
Inspection date: 06-01-2021
The report shows that:
record of the firm. Audit trail was active Labsolutions
version 6.86 SP 2 software of HPLC system used in
the method validation and stability study. Individual
user log in and IDs were available.
• Audit trail reports were available and checked
randomly.
• Continuous power supply and monitoring are
available for stability chambers supported by backup
generators and robust alarm system.
2. Approval of API/ DML/GMP certificate of The firm have submitted copy of GMP certificate
API manufacturer issued by concerned #19061470 dated 02/07/2019 of M/s CTX Lifesciences
regulatory authority of country of origin. Pvt. Ltd., Block No: 251/P, 252/P, 253 to 255, 256/P,
258/P, 276/P, 277, 278/P, 279 to 282, 283/P, 284/P,
GIDC, City Sachin, District Surat GUJARAT STATE,
INDIA issued by Food & Drugs Control
Administration Gandhinagar, Gujrat India valid upto
01/07/2022.
Firm has also submitted retention of Licence No;
G/25/1723 in the name of M/s CTX Lifesciences Pvt.
Ltd., Block No: 251/P, 252/P, 253 to 255, 256/P,
258/P, 276/P, 277, 278/P, 279 to 282, 283/P, 284/P,
GIDC, City Sachin, District Surat GUJARAT STATE,
INDIA that has been retained from 24/01/2021 to 2026
3. Documents for the procurement of API Firm has submitted commercial invoice No.
with approval from DRAP (in case of EI/30002100553 dated 12/12/2020 in the name of M/s
import). Shaigan Pharmaceutical (Pvt.) Ltd. for import of 25Kg
Ondansetron HCL (Batch No 20ON00040) from CTX
Lifesciences Pvt. Ltd. India attested by AD (I&E)
DRAP Islamabad on 29/12/2020.
4. Data of stability batches will be supported Data of stability batches supported by attested
by attested respective documents like respective documents like chromatograms, Raw data
chromatograms, Raw data sheets, COA, sheets, summary data sheets is submitted
5. Compliance Record of HPLC software Compliance Record of HPLC software 21CFR & audit
21CFR & audit trail reports on product trail reports on product testing is submitted
testing
6. Record of Digital data logger for Record of Digital data logger for temperature and
temperature and humidity monitoring of humidity monitoring of stability chambers (real time
stability chambers (real time and and accelerated) is submitted
accelerated)
Remarks of Evaluator XI:
Section Observations Response
1.3.4 • Submit valid DML as the submitted The firm has submitted valid DML
DML expires on 06-01-2021
1.3.5 • Latest GMP inspection report/ GMP The firm has submitted valid GMP
certificate of the manufacturing unit inspection report issued on 28th December
issued within the last three years shall 2021 based on inspection conducted on 04-
be submitted 11-2021
3.2.S.4 • Copies of the Drug substance Firm has submitted Copies of the Drug
specifications and analytical substance specifications and analytical
procedures used for routine testing of procedures used for routine testing of the
the Drug substance /Active Drug substance /Active Pharmaceutical
Pharmaceutical Ingredient by both Ingredient by both Drug substance
Drug substance manufacturer and Drug manufacturer and Drug Product
Product manufacturer is required. manufacturer.
3.2.S.7 • Submit readable copy of stability study The firm has submitted readable copy of
of drug substance stability study of drug substance. However
stability study is not performed at per zone
IV-A conditions
3.2.P.2 • Justification is required since Firm has submitted that pharmaceutical
pharmaceutical equivalence have not equivalence has been established on the
been conducted against the innovator basis of qualitative composition of Zofran
product. oral solution (Innovator Product).
Qualitative formulation of Zedron oral
solution (test product) is in accordance with
innovator product.
As this product exists in USP
pharmacopeia so both test and comparator
product were tested as per parameters of
innovator product for following tests
according to monograph of Ondansetron
Oral solution USP 43. Description,
Identification, pH, Related compounds,
Assay, Microbial enumeration test and test
for specified microorganism.
It is concluded that formulation and
physicochemical test of product under test
(Zedron Oral solution) is in accordance
with formulation of Zofran oral solution
(Innovator) and all tests are within limits as
described by USP, so test product (Zedron
Oral solution) is in pharmaceutical
equivalence with innovator product Zofran
oral solution (Innovator)
3.2.P.6 • COA of primary / secondary reference Firm has submitted COA of working
standard including source and lot standard including source and lot number
number shall be provided.
3.2.P.8 • COA of all batches during the stability Firm has submitted COA of all batches
study at both real time and accelerated during the stability study at both real time
conditions at 3rd month and 6th month and accelerated conditions at 3rd month and
time point is not submitted 6th month time point.
Decision: Approved.
• Firm will submit stability studies data of the drug substance as per the conditions of zone IV-A or
otherwise provide degradation studies of the finished product for 6 months as per the decision of
Registration Board before issuance of Registration letter
64. Name, address of Applicant / Marketing M/s Caliph Pharmaceuticals (Pvt) Ltd. Plot No 17,
Authorization Holder Special Industrial Zone (EPZ), Risalpur
Name, address of Manufacturing site. M/s Caliph Pharmaceuticals (Pvt) Ltd. Plot No 17,
Special Industrial Zone (EPZ), Risalpur
☐ Importer
☐ Export sale
(Slip#27580475902)
The proposed proprietary name / brand CALSETRON 8mg Tablet
name
Pharmaceutical ingredient (API) per unit Ondansetron (as hydrochloride dihydrate)……8mg
Pharmaceutical form of applied drug Film coated tablet
Pharmacotherapeutic Group of (API) Serotonin (5HT3) antagonist
specifications
The status in reference regulatory Zofran 8mg film coated tablet MHRA approved
authorities
For generic drugs (me-too status) Zofran 8mg Tablet by M/s Novartis Pharma Karachi
(Pakistan) (Reg#084164)
Name and address of API manufacturer. M/s Anugraha Chemicals, No D-47, D-48, D-49, D-
50, C-62 and C-63, KSSIDC, Industrial Estate,
Doddaballapur, Bengaluru, Dist: Bengaluru Rural-
561203 India
Module III (Drug Substance) The firm as submitted detail of nomenclature,
form, manufacturers, tests for impurities,
system and stability studies of drug substance
Batches: (AOND-10003, AOND-10004, AOND-
10005)
specifications, analytical procedure and its verification
comparative dissolution profile against the brand that is Zofran 8mg Tablet by
Novartis Pharma by performing quality tests
dosage form).
is Zofran 8mg Tablet by Novartis Pharma in 0.1 N
HCl, 4.5 pH acetate buffer and 6.8pH phosphate
buffer. Both the test and reference product show more
than 85% release in 15 minutes.
Analytical method validation/verification Firm have submitted Method verification studies
Manufacturer of API M/s Anugraha Chemicals, No D-47, D-48, D-49, D-50, C-62 and C-63,
KSSIDC, Industrial Estate, Doddaballapur, Bengaluru, Dist: Bengaluru
Rural-561203 India
API Lot No. AOND-19010
Description of Pack Alu-PVC blister packed in unit carton
Batch No. T-001 T-002 T-003
No. of Batches 03
applications with stability study data of the authenticity of stability data of their product by the
firm (if any) panel on the basis of which Registration Board in 308th
meeting dated 21-22nd June 2021 decided to approve
registration of Dexcal (Dexlansoprazole) 30mg &
60mg capsule.
Inspection date: 01st June, 2021 (Morning)
• The HPLC software is 21 CFR compliant as per
• The firm showed the audit trail reports on API and
product testing
• Continuous power supply and monitoring are
available for stability chambers
2. Approval of API/ DML/GMP certificate of The firm has submitted copy of GMP certificate
API manufacturer issued by concerned #DCD/SPL.CL-1/CR-1510/2020-21 dated 06-02-2021
regulatory authority of country of origin. of M/s Anugraha Chemicals, No D-47 to D-50, C-62
and C-63, KSSIDC, Industrial Estate, Doddaballapur,
Bengaluru Rural District-561203 India issued by
Drugs Control Department Government of Karnataka
valid upto one year from the date of issue.
3. Documents for the procurement of API Firm has submitted commercial invoice No#ZHI-
with approval from DRAP (in case of CI/3966/1119 dated 07/11/2019 in the name of M/s
import). Caliph Pharmaceuticals Pvt. Ltd. for import of 1.00Kg
Ondansetron HCL (Batch No AOND-19010) from
Zeon-Health Industries India attested by AD (I&E)
DRAP Peshawar on 20/11/2019.
chromatograms, Raw data sheets, COA, sheets, summary data sheets is submitted
testing
stability chambers (real time and and accelerated) is submitted
accelerated)
1.3.4 • Submit valid DML as the submitted Firm has submitted copy of receiving letter
DML expires on 12-08-2022 applied for renewal of DML No. 000748
dated 10-08-2022
1.6.5 • Valid GMP certificate / DML of drug The firm has submitted copy of GMP
substance manufacturer issued by certificate #DCD/SPL-1/CR-1733/2021-22
relevant regulatory authority of dated 31-01-2022 of M/s Anugraha
country of origin is required Chemicals, No D-47 to D-50, and C-62,
KSSIDC, Industrial Estate, Doddaballapur,
Bengaluru Rural District-561203 India
issued by Drugs Control Department
Government of Karnataka valid upto one
year from the date of issue.
3.2.S.6 • Details of container closure system Details of container closure system for
for ciprofloxacin HCl is provided Ondansetron HCl is submitted
instead of Ondansetron HCl
3.2.P.3 • Protocols for process validation is not Firm has submitted protocols for process
submitted validation
3.2.P.5 • Submit summary of analytical method Report of analytical method verification
verification studies for drug product studies of drug product is submitted
3.2.P.8 • Justification is required since you • The firm submitted that we have included
have mentioned Uniformity of dosage content uniformity test as per USP
units (content uniformity test) as per monograph in the drug product
USP monograph in batch analysis and specification and also at batch release.
drug product specifications, while you However, during stability studies, we have
have performed weight variation test not performed content uniformity test
in stability study of all three batches at since it was not part of our stability
both accelerated and real time specifications, instead we have performed
conditions. weight variation test during stability
• COA of all batches during the stability studies as per our stability specifications.
study at both real time and accelerated • The firm stated that we have submitted
conditions at 3rd month and 6th month raw data sheets in the form of analytical
time point is not submitted report to provide results of assay and
• Submit UV spectra / absorbance of dissolution test along with calculations as
samples analysed in dissolution study. per the guidelines of Registration Board.
Furthermore, justify single absorbance Analytical reports at each time point for all
value of sample and standard solution batches is again submitted.
in dissolution studies. • The firm stated that our UV system
• Drug substance manufacturer as per display the absorbance results on its
section 3.2.S.2 is M/s Anugraha display screen and does not have the
chemicals India while Drug substance provision of printing the results. We note
is imported from M/s Zeon Health the results in form of absorbance values in
industries India as per submitted QC registers and maintain all the records
invoice, clarification is required along with logs.
• Compliance Record of HPLC • The firm stated that the UV absorbance
software 21CFR & audit trail reports values submitted in the analytical reports
on product testing is required were average values. Now we are
submitting the UV absorbance values for
each analysis as well.
• The firm submitted that M/s Zeon Health
Industries India is supplier while the
manufacturer of the API is M/s Anugraha
Chemicals which is evident from the COA
as well as Clearance certificate. The COA
and clearance certificate is submitted.
• The firm submitted that the stability
studies for the instant product has been
performed on HPLC system which is not
21 CFR compliant, hence audit trail reports
are also not available.
Decision: Approved.
• Registration Board directed the firm to include test of content uniformity as per USP monograph
in drug product specifications for the commercial batches.
Case No. 02; New application for registration of drugs with stability study data on Form 5-D on
export facilitation
Assistant director PR-I/EFD vide letter No.F.1-6/2019-PR-I (EFD dated 06-10-2022 has informed that
DRAP Authority in its 133rd meeting held on 13th April 2022, decided to grant registration on priority
basis to the pharmaceutical i.e one molecule for each 100,000 USD worth of export of medicines (to a
maximum of 15 such molecules) during a fiscal year. In compliance to the aforementioned decision of
the authority, the following firm have achieved the benchmark of more than 100,000 USD during the
fiscal Year 2020-2021 and submitted their applications for priority consideration in lieu of export
facilitation for Registration Board please.,
65. Name and address of manufacturer / M/s PharmEvo (Private) Limited., A-29, North
Applicant Western Industrial Zone, Port Qasim Karachi
Brand Name +Dosage Form + Strength Empalin 10+5mg Tablet
Composition Each Tablet Contains:
Empagliflozin…..………..10mg
Linagliptin………………..5mg
Diary No. Date of R& I & fee Dy. No. 778 dated 02-11-2015, Rs: 50,000/-
dated 02-11-2015
Duplicate Dossier R&I verified
Pharmacological Group Type 2 Diabetes mellitus
Type of Form Form 5D
Finished product Specifications Manufacturer specifications
Pack size & Demanded Price 30’s; As per SRO
Approval status of product in GLYXAMBI® (empagliflozin;linagliptin)
Reference Regulator Authorities (10mg;5mg, 25mg;5mg) film coated tablets
USFDA Approved
Me-too status NA
GMP status Not submitted
Remarks of the Evaluator
Manufacturer of API M/s Jiangsu Yungan Pharmaceutical CO., Ltd., No. 18, 237
Provincial Road, Economic Development Zone, Huaian, Jiangsu
China
API Lot No. Empagliflozin: 4500-202006001
Linagliptin: 7700202005001
Description of Pack Alu-Alu blister packed in unit carton
Stability Storage Condition Real time: 30°C ± 2° C / 75% ± 5% RH
Accelerated: 40 °C ± 2 °C / 75% ± 5%
Frequency Real Time: 0, 3, 6 (month)
Accelerated: 0, 3, 6 (month)
No. of Batches 03
Date of Submission 09-11-2021 (30633)
Sr. No. Documents to Be Provided Status
1. Reference of previous approval of The firm has referred to previous inspection
applications with stability study data of the for authenticity of stability data of their
firm product conducted by the panel on the basis of
which Registration Board in 293rd meeting
dated 6th-8th January, 2020 decided to approve
registration of Erli Plus SR Tablets 5/1000mg,
Erli Plus SR Tablets 10/1000mg, Erli Plus SR
Tablets 12.5/1000mg, Erli Plus SR Tablets
25/1000mg.
Inspection date: 05th December, 2019
• The HPLC software is 21 CFR compliant as
• Audit Trail on the testing reports are
available.
• The firm has 16 stability chambers, 02 for
accelerated and 14 for real time stability
testing. All chambers are properly qualified.
All chambers are provided with continuous
power supply and data loggers for continuous
monitoring.
2. Certificate of Analysis of API from both Empagliflozin:
API Manufacturer and Finished Product Copy of COA (Batch#4500-202006001) of
manufacturer. Empagliflozin from M/s Jiangsu Yungan
Pharmaceutical CO., Ltd China and M/s
PharmEvo (Private) Limited is submitted.
Linagliptin:
Copy of COA (Batch#7700202005001) of
Linagliptin from M/s Jiangsu Yungan
3. Method used for analysis of API from both Method used for analysis of API from both
API Manufacturer and Finished Product API Manufacturer and Finished Product
Manufacturer Manufacturer is provided by the firm.
4. Stability study data of API from API Linagliptin:
manufacturer Firm has submitted stability study data of
Empagliflozin as per zone IV-A. Stability
study is conducted at Real time conditions;
30°C ± 2°C / 65% ± 5%RH for 36 months and
at Accelerated conditions; 40°C ± 2°C / 75% ±
5%RH for 06 months
Batches: (20180201,20180202, 20180301)
Empagliflozin:
Firm has submitted stability study data of
5%RH for 12 months
Batches: (130701, 130702, 130801)
5. Approval of API/ DML/GMP certificate of Firm has submitted copy of GMP certificate in
API manufacturer issued by concerned the name of M/s Jiangsu Yungan
regulatory authority of country of origin. Pharmaceutical CO., Ltd., No. 18, 237
Provincial Road, Economic Development
Zone, Huaian, Jiangsu China issued by
Huaian Pharmaceutical Industry
Association No. 168, West Chaoyang Road,
Qingpu Industrial Park, Huaian, Jiangsu
valid upto 14-01-2024.
6. Documents for the procurement of API Empagliflozin:
with approval from DRAP (in case of Firm has submitted copy of invoice No.
import). ZY20072302G/W dated 23-07-2020 for
import of 15kg of Empagliflozin (Batch#4500-
202006001) in name of M/s PharmEvo
(Private) Limited attested by AD (I&E) DRAP
Karachi dated 30-07-2020.
Linagliptin:
Firm has also submitted copy of invoice No.
ZY20060101G/W dated 01-07-2020 for
import of 0.5kg of Linagliptin in name of M/s
PharmEvo (Private) Limited attested by AD
(I&E) DRAP Karachi dated 10-06-2020.
7. Protocols followed for conduction of Submitted
stability study
8. Method used for analysis of FPP Submitted
9. Drug-excipients compatibility studies The firm submitted that they used the same
(where applicable) excipient as that of innovator
10. Complete batch manufacturing record of The firm has submitted Batch Manufacturing
three stability batches. record of following 03 Batches:
Batch No. Batch Size Mfg. Date
20PD-3443-01- 2500 11-2020
T tablets
20PD-3444-02- 2500 11-2020
T tablets
20PD-3445-03- 2500 11-2020
T tablets
11. Record of comparative dissolution data Comparative dissolution data of applied
(where applicable) product was performed against innovator
brand Glyxambi 10+5mg tablet by M/s
Boehringer Ingelheim Pharmaceuticals, Inc. in
dissolution medium pH 1.2, pH 4.5 and pH 6.8
buffer. The results of both product show more
than 85% drug release of both the API within
15minutes in all three media hence F2 factor
was not calculated
12. Data of 03 batches will be supported by Submitted
testing.
accelerated)
REMARKS OF EVALUATOR XI
Deficiency/Observation Response by Firm
• The reference formulation is film coated while • The firm submitted that the product has
you have applied for uncoated tablets. Revise the been developed in accordance with
label claim as per reference formulation along innovator product as film coated tablets.
with submission of applicable fee The firm has revised label claim in form 5D
along with submission of Rs 7500/- on
deposit slip No. 847973002788. The
revised label claim is as under:
Each film coated Tablet Contains:
• Submit GMP inspection report/ GMP certificate • The firm has submitted cGMP certificate
of the manufacturing unit issued within the last issued on 22nd August 2022 based on
three years shall be submitted inspection conducted on 23rd June 2022.
• Submit valid GMP certificate of API • Firm has again submitted copy of GMP
manufacturer issued by the relevant regulatory certificate in the name of M/s Jiangsu
authority of country of origin Yongan Pharmaceutical CO., Ltd., No. 18,
237 Provincial Road, Economic
Development Zone, Huaian, Jiangsu China
issued by Huaian Pharmaceutical
Industry Association No. 168, West
Chaoyang Road, Qingpu Industrial Park,
Huaian, Jiangsu valid upto 14-01-2024.
• The firm has also submitted DML # (Su
20160324) of M/s Jiangsu Yongan
Pharmaceutical CO., Ltd., No. 18, 237
Zone, Huaian, Jiangsu China valid upto
December 06, 2025.
• Clarification is required since Chromatographic • The firm submitted the testing method of
conditions i.e. Mobile phase and wavelength used finished product i.e. Empalin 10+5mg
for assay of empagliflozin by finished product tablet has been developed in accordance
manufacturer (buffer;acetonitrile 40;60, with the ICH Q14 than the validation of
wavelength 210nm) is different than API method has been performed accordingly. It
manufacturer (methanol;water 68;32, wavelength may be noted that the testing method of API
224nm,) manufacturer has not been adopted while
developing the testing method of finished
product, therefore there is difference in
wavelength of API and FP testing method.
conditions i.e. Mobile phase and column oven finished product i.e. Empalin 10+5mg
temperature used for assay of linagliptin by tablet has been developed in accordance
finished product manufacturer (acetonitrile:water with the ICH Q14 than the validation of
60;40, Temp 25ºC) is different than API method has been performed accordingly. It
manufacturer (Mobile phase-A Buffer:Methano may be noted that the testing method of API
90;10 Mobile phase-B manufacturer has not been adopted while
Acetonitril:water:methanol 700:150:150, Temp developing the testing method of finished
45ºC). Furthermore, API manufacturer have used product, therefore there is difference in
gradient elution while you have used isocratic
method for analysis
• Clarification is required since you have • The firm submitted that in accordance with
mentioned the use of 500ml of dissolution media the clinical pharmacology and
in analytical method for analysis of finished biopharmaceutics review, application
product instead of 900ml as mentioned by number 206073Orig1s000, center for drug
innovator product review document/ USFDA evaluation and research the recommended
drug database dissolution medium is 500ml, as under;
1. Dissolution method; Apparatus 2, 100 rpm
agitation rate, 500ml media volume, 37ºC,
50Mm potassium phosphate buffer, pH 6.8
2. Dissolution acceptance criteria; at 30 min
• It is to mention that 500ml dissolution
media is mentioned with 100rpm while firm
has mentioned 50rpm and USFDA drug
dissolution database recommends the use of
900ml dissolution media with 50 rpm
Decision: Approved with innovator’s specifications with following label claim:
Each film coated tablet Contains:
• Registration Board further decided to verify fee challan as per decision of 285 th meeting of
Registration Board.
66. Name and address of manufacturer / M/s PharmEvo (Private) Limited., A-29, North
Applicant Western Industrial Zone, Port Qasim Karachi
Brand Name +Dosage Form + Strength Empalin 25+5mg Tablet
dated 02-11-2015
Pharmacological Group Type 2 Diabetes mellitus
Pack size & Demanded Price 30’s; As per SRO
USFDA Approved
Me-too status NA
GMP status Not submitted
Manufacturer of API M/s Jiangsu Yungan Pharmaceutical CO., Ltd., No. 18, 237
Provincial Road, Economic Development Zone, Huaian, Jiangsu
China
Linagliptin: 7700202005001
Accelerated: 40 °C ± 2 °C / 75% ± 5%
No. of Batches 03
which Registration Board in 293rd meeting
dated 6th-8th January, 2020 decided to approve
registration of Erli Plus SR Tablets 5/1000mg,
Erli Plus SR Tablets 10/1000mg, Erli Plus SR
Tablets 12.5/1000mg, Erli Plus SR Tablets
25/1000mg.
available.
• The firm has 16 stability chambers, 02 for
testing. All chambers are properly qualified.
All chambers are provided with continuous
power supply and data loggers for continuous
monitoring.
API Manufacturer and Finished Product Copy of COA (Batch#4500-201909001) of
manufacturer. Empagliflozin from M/s Jiangsu Yungan
Linagliptin:
Copy of COA (Batch#7700202005001) of
Linagliptin from M/s Jiangsu Yungan
5%RH for 06 months
Batches: (20180201,20180202, 20180301)
Empagliflozin:
5%RH for 12 months
Batches: (130701, 130702, 130801)
API manufacturer issued by concerned the name of M/s Jiangsu Yungan
regulatory authority of country of origin. Pharmaceutical CO., Ltd., No. 18, 237
Zone, Huaian, Jiangsu China issued by
import of 15kg of Empagliflozin in name of
M/s PharmEvo (Private) Limited attested by
AD (I&E) DRAP Karachi dated 22-10-2019.
Linagliptin:
Firm has submitted copy of invoice No.
ZY20060101G/W dated 01-07-2020 for
import of 0.5kg of Linagliptin in name of M/s
PharmEvo (Private) Limited attested by AD
stability study
9. Drug-excipients compatibility studies The firm submitted Formulation of applied
(where applicable) drug product is qualitatively similar to that of
innovator product Glyxambi 25mg/5mg tablet.
20PD-3396-02- 2500 11-2020
T tablets
20PD-3397-03- 2500 11-2020
T tablets
20PD-3398-04- 2500 11-2020
T tablets
(where applicable) product was performed against innovator
brand Glyxambi 25+5mg tablet by M/s
Boehringer Ingelheim Pharmaceuticals, Inc. in
dissolution medium pH 1.2, pH 4.5 and pH 6.8
buffer. The results of both product show more
than 85% drug release of both the API within
15minutes in all three media hence F2 factor
was not calculated
testing.
accelerated)
• The reference formulation is film coated while • The firm submitted that the product has
you have applied for uncoated tablets. Revise the been developed in accordance with
label claim as per reference formulation along innovator product as film coated tablets.
with submission of applicable fee The firm has revised label claim in form 5D
along with submission of Rs 7500/- on
deposit slip No. 18865905426. The revised
label claim is as under:
of the manufacturing unit issued within the last issued on 22nd August 2022 based on
three years shall be submitted inspection conducted on 23rd June 2022.
• Submit valid GMP certificate of API • Firm has again submitted copy of GMP
manufacturer issued by the relevant regulatory certificate in the name of M/s Jiangsu
authority of country of origin Yungan Pharmaceutical CO., Ltd., No. 18,
Development Zone, Huaian, Jiangsu China
December 06, 2025.
conditions i.e. Mobile phase and wavelength used finished product i.e. Empalin 25+5mg
for assay of empagliflozin by finished product tablet has been developed in accordance
manufacturer (buffer;acetonitrile 40;60, with the ICH Q14 than the validation of
wavelength 210nm) is different than API method has been performed accordingly. It
manufacturer (methanol;water 68;32, wavelength may be noted that the testing method of API
224nm,) manufacturer has not been adopted while
developing the testing method of finished
product, therefore there is difference in
conditions i.e. Mobile phase and column oven finished product i.e. Empalin 10+5mg
temperature used for assay of linagliptin by tablet has been developed in accordance
finished product manufacturer (acetonitrile:water with the ICH Q14 than the validation of
60;40, Temp 25ºC) is different than API method has been performed accordingly. It
manufacturer (Mobile phase-A Buffer:Methano may be noted that the testing method of API
90;10 Mobile phase-B manufacturer has not been adopted while
Acetonitril:water:methanol 700:150:150, Temp developing the testing method of finished
45ºC). Furthermore, API manufacturer have used product, therefore there is difference in
gradient elution while you have used isocratic wavelength of API and FP testing method.
method for analysis
• Clarification is required since you have • The firm submitted that in accordance with
mentioned the use of 500ml of dissolution media the clinical pharmacology and
in analytical method for analysis of finished biopharmaceutics review, application
product instead of 900ml as mentioned by number 206073Orig1s000, Center for Drug
innovator product review document/ USFDA Evaluation and Research the recommended
drug database dissolution medium is 500ml, as under;
3. Dissolution method; Apparatus 2, 100 rpm
agitation rate, 500ml media volume, 37ºC,
50Mm potassium phosphate buffer, pH 6.8
4. Dissolution acceptance criteria; at 30 min
• It is to mention that 500ml dissolution
media is mentioned with 100rpm while firm
has mentioned 50rpm and USFDA drug
dissolution database recommends the use of
900ml dissolution media with 50 rpm
Decision: Approved with innovator’s specifications and following label claim:
Each film coated Tablet contains:
• Registration Board further decided to verify fee challan as per decision of 285th meeting of
Registration Board.
67. Name and address of manufacturer / M/s Tabros Pharma (Pvt) Ltd., L-20/B, Sector-22,
Applicant F.B. Industrial Area, Karachi
Brand Name +Dosage Form + Strength Klic-Quick Sachet 50mg/Sachet
Composition Each Sachet Contains:
Diclofenac Potassium…..……….50mg
dated 17-04-2015, Balance Fee Rs. 30,000/- dated
11-07-2017
Pharmacological Group NSAID
Pack size & Demanded Price As per SRO
Approval status of product in CAMBIA 50mg for oral solution USFDA
Reference Regulator Authorities Approved
Me-too status Diclovis-K 50mg Sachet by M/s Vision
Pharmaceuticals (Reg#109783)
GMP status The firm was inspected on 25-03-2018 and
conclusion of inspection was:
Manufacturer of API M/s Henan Dongtai Pharmacetical CO., Ltd., East Changhong Road,
Tangyin County, Anyang City, China
API Lot No. 303200720-5
Description of Pack White to off white granular powder., packed in Aluminium paper foil
(Container closure system) laminated sachet
Accelerated: 40 °C ± 2 °C / 75% ± 5%
Batch No. TR001-1/KIQ TR002-1/KIQ TR003-1/KIQ
Batch Size 1000 sachet 1000 sachet 1000 sachet
No. of Batches 03
1. Reference of previous approval of Not provided
firm
2. Certificate of Analysis of API from both Copy of COA (Batch#303200720-5) of
API Manufacturer and Finished Product Diclofenac potassium from M/s Henan
manufacturer. Dongtai Pharm CO., Ltd China and M/s
Tabros Pharma (Pvt) Ltd is submitted.
4. Stability study data of API from API Firm has submitted stability study data of
manufacturer Diclofenac potassium as per zone IV-A.
Stability study is conducted at Real time
conditions; 30°C ± 2°C / 65% ± 5%RH for 48
months and at Accelerated conditions; 40°C ±
2°C / 75% ± 5%RH for 06 months
Batches: (131118-5, 131118-6, 131119-5,)
5. Approval of API/ DML/GMP certificate of Firm has submitted copy of GMP certificate
API manufacturer issued by concerned No. HA20170001 in the name of M/s Henan
regulatory authority of country of origin. Dongtai Pharmacetical CO., Ltd., East
Changhong Road, Tangyin County, Anyang
City, China issued by Henan Province Food
and Drug Administration valid upto 22-01-
2022.
6. Documents for the procurement of API Firm has submitted copy of Form 6 for import
with approval from DRAP (in case of of 350gm of Diclofenac Potassium from M/s
import). Henan Dongtai Pharm Co., Ltd, China attested
by AD (I&E) DRAP Karachi dated 07-06-
2021.
DT210505F dated 25-05-2021 for import of
350gm of Diclofenac Potassium in name of
M/s Tabros Pharma (Pvt) Ltd., Karachi
attested by AD (I&E) DRAP Karachi dated 07-
06-2021.
stability study
9. Drug-excipients compatibility studies NA
(where applicable) (Firm submitted that as same excipients used
as used by the innovator so compatibility
studies with excipient are not required).
TR001-1/KIQ 1000 sachet 08-2021
TR002-1/KIQ 1000 sachet 08-2021
TR003-1/KIQ 1000 sachet 08-2021

(where applicable) product was performed against Voltfast 50mg
sachet by M/s Novartis Pharma in dissolution
medium 0.1N HCl pH 1.2, Acetate Buffer pH
4.5, Phosphate Buffer pH 6.8 and Phosphate
Buffer in 0.1N HCl pH 6.8 (QC Medium). The
values of F2 factor was in acceptable range in
all media
testing.
accelerated)
You have applied for manufacturer specification The firm submitted that Since the product
while the monograph for applied product is was applied on “FORM 5D” at that time we
available in USP. have been searching this product in
compendia monograph with the name
Diclofenac potassium SACHET, the same
name could not be found, Hence, mentioned
manufacturer specification. After, we
purchased the Innovator pack to perform the
CDP, in innovator pack it is visibly
mentioned that the product is POWDER
FOR ORAL SOLUTION hence we have
followed USP specification & performed
analysis of stability samples as per USP
monograph.
of the manufacturing unit issued within the last issued on 15th April 2022 based on
three years shall be submitted inspection conducted on 07th April 2022
• Submit valid GMP certificate of API • Firm has submitted cGMP certificate
manufacturer issued by the relevant regulatory No#HA20190077 of M/s Henan Dongtai
authority of country of origin Pharmaceutical Co., Ltd., No. 2, East
Kangtai Road, Tangyin ounty, Anyang City
China. Valid issued by Henan Province
Drug Administration valid upto 05-11-2024
• The firm further submitted undertaking
from API manufacturer stating that our
site address changed from East
Changhong Road, Tangyin County,
Anyang City, China to No. 2, East Kangtai
Road, Tangyin, Anyang, Henan China.
• Clarification is required since Chromatographic • The firm submitted that for the
conditions i.e. Mobile phase composition, column determination of Assay and Impurities SIM
oven temperature, column length, diluent method was developed
composition and injection volume used for assay • We acquired the USP diclofenac potassium
of diclofenac potassium sachet by finished method of drug substance under the
product manufacturer (methanol; solution A heading of organic impurities, Mobile
(70;30), Temp Ambient, column length 250mm, phase composition, column oven
injection volume 30ul) is different than that temperature, column length, diluent
recommended by USP. (Acetonitrile and Solution composition and injection volume are all
A (40:60), Temp 40ºC, column length 150mm, followed same as USP organic impurities
injection volume 20ul) method along with chromatographic
conditions.
INDICATIONS AND USAGE
CAMBIA is indicated for the acute treatment of migraine attacks with or without aura in adults (18
years of age or older).
Limitations of Use
• CAMBIA is not indicated for the prophylactic therapy of migraine.
• The safety and effectiveness of CAMBIA have not been established for cluster headache, which is
present in an older, predominantly male population.
DOSAGE AND ADMINISTRATION
Acute Treatment of Migraine
Administer one packet (50 mg) of CAMBIA for the acute treatment of migraine. Empty the
contents of one packet into a cup containing 1 to 2 ounces or 2 to 4 tablespoons (30 to 60 mL) of
water, mix well and drink immediately.
Do not use liquids other than water.
Taking CAMBIA with food may cause a reduction in effectiveness compared to taking CAMBIA on
an empty stomach. Use the lowest effective dose for the shortest duration consistent with individual
patient treatment goals.
The safety and effectiveness of a second dose have not been established.
Decision: Approved with USP specifications.
• Registration Board directed the firm to perform analysis of finished product as per USP
monograph on next time point of long term stability study and submit data before issuance of
registration letter
specifications, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021
• Registration Board further decided to verify fee challan as per decision of 285th meeting of
Registration Board.
68. Name and address of manufacturer / M/s Macter International Limited F-216, S.I.T.E
Applicant Karachi
Brand Name +Dosage Form + Strength Empozin-L 10mg+5mg Tablet
dated 06-03-2019
Pharmacological Group Combinations of oral blood glucose lowering
drugs
Pack size & Demanded Price 14’s, 28’s; As per SRO
USFDA Approved
Me-too status NA
The firm is found to be complying at a good level
of GMP compliance at the time of inspection.
Continuous improvements for procedures shall be
followed in letter and spirit as per the Drug Act
1976, DRAP Act 2012 and rules framed there
under.
Manufacturer of API M/s Fuxin Long Rui Pharmaceutical CO., Ltd., Fluoride Industrial
Park, Fuxin City, Liaoning Province-123000, China
API Lot No. Empagliflozin: E-20190920-D02-E06-01
Linagliptin: L-20190305-D01-L09-08
Accelerated: 40 °C ± 2 °C / 75% ± 5%
Frequency Real Time: 0, 1, 3, 6, 9 (month)
Accelerated: 0, 1, 3, 6 (month)
Batch No. 20SB-212-002 20SB-213-003 20SB-214-004
No. of Batches 03
which Registration Board in 296th meeting
dated 8th, 9th & 10th September, 2020 decided
to approve registration of Vireof-N 25mg
Tablets.
• Audit Trail on the testing reports on
Tenofovir Alafenamide Fumarate API and
Vireof-N tablets 25mg is available.
• The firm has adequate monitoring and
control system for stability chambers.
API Manufacturer and Finished Product Copy of COA (Batch#E-20190920-D02-E06-
manufacturer. 01) of Empagliflozin from M/s Fuxin Long
Rui Pharmaceutical CO., Ltd China and M/s
Macter International Ltd is submitted.
Linagliptin:
Copy of COA (Batch#L-20190305-D01-L09-
08) of Linagliptin from M/s Fuxin Long Rui
Linagliptin. Stability study is conducted at
Real time conditions; 25°C ± 2°C / 60% ±
5%RH for 12 months and at Accelerated
months
Batches: (L-20170429-D01-L9-01, L-
20170604-D01-L9-02, L-20170604-D01-L9-
03)
Empagliflozin:
Empagliflozin. Stability study is conducted at
months
Batches: (20160606, 20161017, 20161219)
API manufacturer issued by concerned the name of M/s Fuxin Long Rui
regulatory authority of country of origin. Pharmaceutical CO., Ltd., Fluoride Industrial
Park, Fuxin City, Liaoning Province-123000,
China issued by Liaoning Fuxin
Management Committee for Fluoride
Industrial Development Zone valid upto 23-
08-2023.
import). HN19122501-H dated 25-12-2019 for import
of 05kg of Empagliflozin (Batch No. E-
20190920-D02-E06-01) in name of M/s
Macter International Limited attested by AD
Linagliptin:
Firm has submitted copy of Form 6 for import
of 1.5kg of Linagliptin from M/s Fuxin Long
Rui Pharmaceutical CO., Ltd China attested by
AD (I&E) DRAP Karachi.
HN/200304-U dated 04-03-2020 for import of
1.5kg of Linagliptin (Batch No. L20190305-
D01-L09-08) in name of M/s Macter
International Limited attested by AD (I&E)
DRAP Karachi dated 17-03-2020.
stability study
(where applicable) (Formulation of applied drug product is
qualitatively similar to that of innovator
product Glyxambi 10mg/5mg tablet).
20SB-212- 5000 06-2020
002 tablets
20SB-213- 5000 06-2020
003 tablets
20SB-214- 5000 06-2020
004 tablets
11. Record of comparative dissolution data Not submitted
(where applicable)
testing.
14. Record of Digital data logger for Not Submitted
accelerated)
Submit valid GMP certificate of API manufacturer • Firm has again submitted copy of GMP
issued by the relevant regulatory authority of certificate in the name of M/s Fuxin Long
country of origin Rui Pharmaceutical CO., Ltd., Fluoride
Industrial Park, Fuxin City, Liaoning
Province-123000, China issued by
Liaoning Fuxin Management Committee
for Fluoride Industrial Development Zone
• Firm has submitted copy of DML
(Certificate# Liao20150233) in the name of
M/s Fuxin Long Rui Pharmaceutical CO.,
Ltd., issued by Liaoning Provincial Drug
Administration, valid upto 20-12-2022.
Submit latest GMP inspection report conducted Firm has submitted cGMP certificate issued
within last three years on 05th August 2022 based on inspection
conducted on 04th August 2022.
In COA of empagliflozin working standard is Firm has submitted separate COA of
written. Clarification is required whether it is COA Empagliflozin API and working standard.
of API or working standard.
Submit stability study data of Linagliptin and • The firm submitted that HVAC system is
Empagliflozin API as per zone IV-A. installed to control the environment to keep
raw material properly in store room (below
25ºC & 45%RH) and we have given finish
good stability data at zone IV-A.
• The firm has not submitted stability study
data of Linagliptin and Empagliflozin API
as per zone IV-A conditions.
CDP studies for the applied product is not • The firm submitted that due to similar
submitted formulation CDP performed on its higher
strength which is Empozin-L 25mg+5mg
tablet but we have also performed CDP for
lower strength (Empozin-L 10mg+5mg
tablet) against Glyxambi 10mg+5mg
tablets in Potassium Phosphate buffer pH
6.8.
• However, it is to submit that as per WHO
guidelines CDP studies should be
performed in at least three media covering
the physiological range, including pH 1.2
hydrochloric acid, pH 4.5 buffer and pH 6.8
buffer and the firm has not performed CDP
as per WHO guidelines
Justification is required as you have not included The firm submitted that content uniformity of
test for content uniformity in drug product core tablets are mentioned.
specification for the applied drug product
Submit Record of Digital data logger for Firm has submitted Record of Digital data
temperature and humidity monitoring of stability logger for temperature and humidity
chambers (real time and accelerated) monitoring of stability chambers (real time
and accelerated)
Decision: Approved with innovator’s specifications.
Firm shall submit following before issuance of registration letter:
• Fee of Rs. 7,500/- for correction/pre-approval change/ in product specifications, as per
• Stability studies data of both the drug substances as per the conditions of zone IV-A or
otherwise provision of degradation studies of the finished product for 6 months as per
the decision of Registration Board before issuance of Registration letter.
• CDP studies for applied formulation in three buffers of pH 1.2, 4.5 and 6.8.
Applicant Karachi
Brand Name +Dosage Form + Strength Empozin-L 25mg+5mg Tablet
dated 06-03-2019
Pharmacological Group Combinations of oral blood glucose lowering
drugs
Pack size & Demanded Price 14’s, 28’s; As per SRO
USFDA Approved
Me-too status NA
under.
Manufacturer of API M/s Fuxin Long Rui Pharmaceutical CO., Ltd., Fluoride Industrial
Park, Fuxin City, Liaoning Province-123000, China
API Lot No. Empagliflozin: E-20190920-D02-E06-01
Linagliptin: L-20190305-D01-L09-08
Accelerated: 40 °C ± 2 °C / 75% ± 5%
Batch No. 20SB-191-005 20SB-192-006 20SB-193-007
No. of Batches 03
Sr. No. Documents to be provided Status
Tablets.
API Manufacturer and Finished Product Copy of COA (Batch#E-20190920-D02-E06-
manufacturer. 01) of Empagliflozin from M/s Fuxin Long
Rui Pharmaceutical CO., Ltd China and M/s
Linagliptin:
Copy of COA (Batch#L-20190305-D01-L09-
08) of Linagliptin from M/s Fuxin Long Rui
Linagliptin. Stability study is conducted at
months
Batches: (L-20170429-D01-L9-01, L-
20170604-D01-L9-02, L-20170604-D01-L9-
03)
Empagliflozin:
Empagliflozin. Stability study is conducted at
months
Batches: (20160606, 20161017, 20161219)
API manufacturer issued by concerned the name of M/s Fuxin Long Rui
regulatory authority of country of origin. Pharmaceutical CO., Ltd., Fluoride Industrial
Park, Fuxin City, Liaoning Province-123000,
China issued by Liaoning Fuxin
Management Committee for Flouride
Industrial Development Zone valid upto 23-
08-2023.
import). HN19122501-H dated 25-12-2019 from
exporter M/s Beijing Sino Hanson Import and
Export Co., Ltd China for import of 05kg of
Empagliflozin (Batch No. E-20190920-D02-
E06-01) in name of M/s Macter International
Limited attested by AD (I&E) DRAP Karachi
dated 31-12-2019.
Linagliptin:
Firm has submitted copy of Form 6 for import
of 1.5kg of Linagliptin from M/s Fuxin Long
Rui Pharmaceutical CO., Ltd China attested by
HN/200304-U dated 04-03-2020 from
exporter M/s Beijing Sino Hanson Import and
Export Co., Ltd China for import of 1.5kg of
Linagliptin (Batch No. L20190305-D01-L09-
08) in name of M/s Macter International
Limited attested by AD (I&E) DRAP Karachi
dated 17-03-2020.
stability study
product Glyxambi 25mg/5mg tablet).
20SB-191- 5000 06-2020
005 tablets
20SB-192- 5000 06-2020
006 tablets
20SB-193- 5000 06-2020
007 tablets
11. Record of comparative dissolution data Not submitted
(where applicable)
testing.
accelerated)
Submit valid GMP certificate of API manufacturer • Firm has again submitted copy of GMP
issued by the relevant regulatory authority of certificate in the name of M/s Fuxin Long
country of origin Rui Pharmaceutical CO., Ltd., Fluoride
Industrial Park, Fuxin City, Liaoning
Province-123000, China issued by
Liaoning Fuxin Management Committee
for Fluoride Industrial Development Zone
• Firm has submitted copy of DML
(Certificate# Liao20150233) in the name of
M/s Fuxin Long Rui Pharmaceutical CO.,
Ltd., issued by Liaoning Provincial Drug
Administration, valid upto 20-12-2022.
Submit latest GMP inspection report conducted Firm has submitted cGMP certificate issued
within last three years on 05th August 2022 based on inspection
conducted on 04th August 2022.
In COA of empagliflozin working standard is Firm has submitted separate COA of
written. Clarification is required whether it is COA Empagliflozin API and working standard.
of API or working standard.
Submit stability study data of Linagliptin and • The firm submitted that HVAC system is
Empagliflozin API as per zone IV-A. installed to control the environment to keep
raw material properly in store room (below
25ºC & 45%RH) and we have given finish
good stability data at zone IV-A.
• The firm has not submitted stability study
data of Linagliptin and Empagliflozin API
as per zone IV-A conditions.
CDP studies for the applied product is not Comparative dissolution studies of applied
submitted product was performed against innovator
brand Glyxambi 25+5mg tablet in
dissolution medium pH 1.2, pH 4.5 and pH
6.8 buffer. The value of F2 factor are in
acceptable range
Justification is required as you have not included The firm submitted that content uniformity of
test for content uniformity in drug product core tablets are mentioned.
specification for the applied drug product
Submit Record of Digital data logger for Firm has submitted Record of Digital data
temperature and humidity monitoring of stability logger for temperature and humidity
and accelerated)
Firm shall submit following before issuance of registration letter:
• Fee of Rs. 7,500/- for correction/pre-approval change/ in product specifications, as per
• Stability studies data of both the drug substances as per the conditions of zone IV-A or
otherwise provision of degradation studies of the finished product for 6 months as per
the decision of Registration Board before issuance of Registration letter.
Applicant Karachi
Brand Name +Dosage Form + Strength Obet 5mg Tablet
Obeticholic Acid……….5mg
dated 16-01-2018
Pharmacological Group Modified bile acid and farnesoid X receptor (FXR)
agonist
Approval status of product in OCALIVA (5mg, 10mg) film coated tablets
Reference Regulator Authorities USFDA Approved
Me-too status Obliva Tablet 5mg by M/s Hilton Pharma
(Reg#108921)
under.
Manufacturer of API M/s Virupaksha Organics Limited India Sy No-10 Gaddapotharam,
Gaddapotharam (V), Jinnaram (M), Sangareddy (Dist.) 502319 India
API Lot No. AOBTC0118002
Accelerated: 40 °C ± 2 °C / 75% ± 5%
Batch No. 20SB-142-001 20SB-143-002 20SB-144-003
No. of Batches 03
firm product conducted by the panel on the basis
of which Registration Board in 296th meeting
Tablets.
2. Certificate of Analysis of API from both API Copy of COA (Batch#AOBTC0118002) of
Manufacturer and Finished Product API from M/s Virupaksha Organics Limited
manufacturer. India and M/s Macter International Ltd is
submitted.
4. Stability study data of API from API Firm has submitted stability study data of API
manufacturer as per zone IV-A. Stability study is conducted
at Real time conditions; 30°C ± 2°C / 65% ±
months
Batches:(AOBTC0217001,
AOBTC0217002, AOBTC0217003)
API manufacturer issued by concerned No; 44139/TS/2020 dated 05-10-2020 in the
regulatory authority of country of origin. name of M/s Virupaksha Organics Limited
India Sy No-10 Gaddapotharam,
Gaddapotharam (V), Jinnaram (M),
Sangareddy (Dist.) 502319 India issued by
Drugs Control Administration Telangana
state India valid upto 05-10-2021.
6. Documents for the procurement of API with Firm has submitted copy of Form 6 for import
approval from DRAP (in case of import). of 250gm of Obeticholic Acid from M/s
Virupaksha Organics Limited India attested
by AD (I&E) DRAP Karachi.
AEX/100/2019-20 dated 11-02-2020 for
import of 250gm of Obeticholic Acid (Batch
No. AOBTC0118002) in name of M/s Macter
stability study
product Ocaliva 5mg tablet).
20SB-142- 5000 05-2020

001 tablets
20SB-143- 5000 05-2020
002 tablets
20SB-144- 5000 05-2020
003 tablets
11. Record of comparative dissolution data Comparative dissolution was performed
(where applicable) against Ocaliva 5mg tablet in dissolution
medium pH 1.2, pH 4.5, pH 6.8 buffer and
FDA dissolution medium (0.05mM Sodium
Phosphate Buffer, pH 6.8 in 0.08% tween 80).
13. Compliance Record of HPLC software Not Submitted
testing.
14. Record of Digital data logger for temperature Not Submitted
and humidity monitoring of stability
chambers (real time and accelerated)
• The reference formulation is film coated while • The firm stated that we have submitted all
you have applied for uncoated tablets. Revise the technical documents on film coated tablets
label claim as per reference formulation along and also revised the label claim along with
with submission of applicable fee submission of Rs. 7500/- on deposit slip#
946567667. The revised label claim is as
under:
• Submit valid GMP certificate of API • Firm has submitted copy of GMP
manufacturer issued by the relevant regulatory certificate No; 70109/TS/2021 dated 27-10-
authority of country of origin 2021 in the name of M/s Virupaksha
Organics Limited India Sy No-10
Gaddapotharam, Gaddapotharam (V),
Jinnaram (M), Sangareddy (Dist.) 502319
India issued by Drugs Control
Administration Telangana state India valid
upto 26-10-2022.
• Submit latest GMP inspection report conducted • Firm has submitted cGMP certificate
within last three years issued on 05th August 2022 based on
inspection conducted on 04th August 2022.
• The European public assessment report has • We have various storage facilities in our
specified the conditions for real time and raw material store., i.e. 2-8ºC, below 15ºC,
accelerated stability studies as 5°C ± 3°C and 25 below 25ºC, below -40ºC and -80ºC.
°C/60% RH, respectively. The drug substance Subject raw material will store as per
manufacturer has provided the data as per Zone require conditions.
IV-A. Justification is required about the stability • The stability in our dossier provided is of
of the drug substance in Zone IV-A as compared manufacturer and it’s part of DMF.
to 5°C ± 3°C
• Clarification is required since the dissolution • The firm submitted that similar dissolution
media mentioned in the submitted application is media used in submitted application (i.e.
different from that of the innovator product given 0.08% Polysorbate 80 in 50 mM Sodium
in FDA dissolution database (0.08% polysorbate phosphate dibasic buffer, pH 6.8).
80 in 50mM sodium phosphate dibasic buffer, pH According to the calculation (for 50mM
6.8) 7.09g sodium phosphate dibasic is required
Applied / used (0.050mM sodium phosphate and we also used 7.09g sodium phosphate
buffer, pH 6.8 in 0.08% tween 80) dibasic but it considered as typing error
0.05mM, its actually 0.05M i.e. equal to
50mM.
• Submit details of manufacturer of Ocaliva 5mg • The firm submitted details of manufacturer
tablet against which CDP study is conducted of Ocaliva 5mg tablet. M/s Intercept
Pharma International Ltd., 31-36 Ormond
Quay Upper Dublin 7, Ireland.
• The limits of assay test mentioned in • The firm submitted that our stability study
specifications is 95-105% while the limits data results of accelerated and long term are
mentioned in stability summary sheets is 90- stable within limits 95-105%. We have
110%, clarification is required corrected specifications and revised
specification is submitted
• Justification is required as you have not included • The firm submitted that content uniformity
test for content uniformity in drug product of core tablets are mentioned in our
specification for the applied drug product application, as our product has non-
functional coating so we didn’t perform CU
on coated tablets.
• Submit compliance Record of HPLC software • The firm has submitted compliance Record
21CFR & audit trail reports on product testing. of HPLC software 21CFR & audit trail
• Submit Record of Digital data logger for • The firm has submitted Record of Digital
temperature and humidity monitoring of stability data logger for temperature and humidity
and accelerated)
INDICATIONS AND USAGE:
Ocaliva is indicated for the treatment of adult patients with primary biliary cholangitis (PBC)
• without cirrhosis or
• with compensated cirrhosis who do not have evidence of portal hypertension,
either in combination with ursodeoxycholic acid (UDCA) with an inadequate response to UDCA or
as monotherapy in patients unable to tolerate UDCA.
WARNING: HEPATIC DECOMPENSATION AND FAILURE IN PRIMARY BILIARY
CHOLANGITIS PATIENTS WITH CIRRHOSIS
• Hepatic decompensation and failure, sometimes fatal or resulting in liver transplant, have been
reported with OCALIVA treatment in primary biliary cholangitis (PBC) patients with either
compensated or decompensated cirrhosis.
• OCALIVA is contraindicated in PBC patients with decompensated cirrhosis, a prior
decompensation event, or with compensated cirrhosis who have evidence of portal hypertension.
• Permanently discontinue OCALIVA in patients who develop laboratory or clinical evidence of
hepatic decompensation; have compensated cirrhosis and develop evidence of portal hypertension;
or experience clinically significant hepatic adverse reactions while on treatment
Applicant Karachi
Brand Name +Dosage Form + Strength Obet 10mg Tablet
dated 16-01-2018
Pharmacological Group Modified bile acid and farnesoid X receptor (FXR)
agonist
Approval status of product in OCALIVA (5mg, 10mg) film coated tablets
Reference Regulator Authorities USFDA Approved
Me-too status Obliva Tablet 10mg by M/s Hilton Pharma
(Reg#108922)
under.
Manufacturer of API M/s Virupaksha Organics Limited India Sy No-10 Gaddapotharam,
Gaddapotharam (V), Jinnaram (M), Sangareddy (Dist.) 502319 India
API Lot No. AOBTC0118002
Accelerated: 40 °C ± 2 °C / 75% ± 5%
Batch No. 20SB-150-001 20SB-151-002 20SB-152-003
No. of Batches 03
Tablets.
2. Certificate of Analysis of API from both Copy of COA (Batch#AOBTC0118002) of
API Manufacturer and Finished Product API from M/s Virupaksha Organics Limited
manufacturer. India and M/s Macter International Ltd is
submitted.
4. Stability study data of API from API Firm has submitted stability study data of API
manufacturer as per zone IV-A. Stability study is conducted
at Real time conditions; 30°C ± 2°C / 65% ±
months
Batches:(AOBTC0217001, AOBTC0217002,
AOBTC0217003)
API manufacturer issued by concerned No; 44139/TS/2020 dated 05-10-2020 in the
regulatory authority of country of origin. name of M/s Virupaksha Organics Limited
India Sy No-10 Gaddapotharam,
Gaddapotharam (V), Jinnaram (M),
Sangareddy (Dist.) 502319 India issued by
Drugs Control Administration Telangana state
India valid upto 05-10-2021.
6. Documents for the procurement of API Firm has submitted copy of Form 6 for import
with approval from DRAP (in case of of 250gm of Obeticholic Acid from M/s
import). Virupaksha Organics Limited India attested by
AEX/100/2019-20 dated 11-02-2020 for
import of 250gm of Obeticholic Acid (Batch
No. AOBTC0118002) in name of M/s Macter
stability study
product Ocaliva 10mg tablet).
20SB-150- 5000 05-2020

001 tablets
20SB-151- 5000 05-2020
002 tablets
20SB-152- 5000 05-2020
003 tablets
(where applicable) against Ocaliva 10mg tablet in dissolution
medium pH 1.2, pH 4.5, pH 6.8 buffer and
FDA dissolution medium (0.05mM Sodium
Phosphate Buffer, pH 6.8 in 0.08% tween 80).
testing.
accelerated)
• The reference formulation is film coated while • The firm stated that we have submitted all
you have applied for uncoated tablets. Revise the technical documents on film coated tablets
label claim as per reference formulation along and also revised the label claim along with
with submission of applicable fee submission of Rs. 7500/- on deposit slip#
392056704846. The revised label claim is
as under:
• Submit valid GMP certificate of API • Firm has submitted copy of GMP
manufacturer issued by the relevant regulatory certificate No; 70109/TS/2021 dated 27-10-
authority of country of origin 2021 in the name of M/s Virupaksha
Organics Limited India Sy No-10
Gaddapotharam, Gaddapotharam (V),
Jinnaram (M), Sangareddy (Dist.) 502319
India issued by Drugs Control
Administration Telangana state India valid
upto 26-10-2022.
• Submit latest GMP inspection report conducted • Firm has submitted cGMP certificate
within last three years issued on 05th August 2022 based on
inspection conducted on 04th August 2022.
• The European public assessment report has • The firm submitted that we have various
specified the conditions for real time and storage facilities in our raw material store.,
accelerated stability studies as 5°C ± 3°C and 25 i.e. 2-8ºC, below 15ºC, below 25ºC, below
°C/60% RH, respectively. The drug substance -40ºC and -80ºC. Subject raw material will
manufacturer has provided the data as per Zone store as per require conditions.
IV-A. Justification is required about the stability • The stability in our dossier provided is of
of the drug substance in Zone IV-A as compared manufacturer and it’s part of DMF.
to 5°C ± 3°C
• Clarification is required since the dissolution • The firm submitted that similar dissolution
media mentioned in the submitted application is media used in submitted application (i.e.
different from that of the innovator product given 0.08% Polysorbate 80 in 50 mM Sodium
in FDA dissolution database (0.08% polysorbate phosphate dibasic buffer, pH 6.8).
80 in 50mM sodium phosphate dibasic buffer, pH According to the calculation (for 50mM
6.8) 7.09g sodium phosphate dibasic is required
Applied / used (0.050mM sodium phosphate and we also used 7.09g sodium phosphate
buffer, pH 6.8 in 0.08% tween 80) dibasic but it considered as typing error
0.05mM, its actually 0.05M i.e. equal to
50mM.
• Submit details of manufacturer of Ocaliva 10mg • The firm submitted details of manufacturer
tablet against which CDP study is conducted of Ocaliva 10mg tablet. M/s Intercept
Pharma International Ltd., 31-36 Ormond
Quay Upper Dublin 7, Ireland.
• The limits of assay test mentioned in • The firm submitted that our stability study
specifications is 95-105% while the limits data results of accelerated and long term are
mentioned in stability summary sheets is 90- stable within limits 95-105%. We have
110%, clarification is required corrected specifications and revised
specification is submitted
• Justification is required as you have not included • The firm submitted that content uniformity
test for content uniformity in drug product of core tablets are mentioned in our
specification for the applied drug product application, as our product has non-
functional coating so we didn’t perform CU
on coated tablets.
• Submit compliance Record of HPLC software • The firm has submitted compliance Record
21CFR & audit trail reports on product testing. of HPLC software 21CFR & audit trail
• Submit Record of Digital data logger for • The firm has submitted Record of Digital
temperature and humidity monitoring of stability data logger for temperature and humidity
and accelerated)
INDICATIONS AND USAGE:
Ocaliva is indicated for the treatment of adult patients with primary biliary cholangitis (PBC)
• without cirrhosis or
• with compensated cirrhosis who do not have evidence of portal hypertension,
either in combination with ursodeoxycholic acid (UDCA) with an inadequate response to UDCA or
as monotherapy in patients unable to tolerate UDCA.
WARNING: HEPATIC DECOMPENSATION AND FAILURE IN PRIMARY BILIARY
CHOLANGITIS PATIENTS WITH CIRRHOSIS
• Hepatic decompensation and failure, sometimes fatal or resulting in liver transplant, have been
reported with OCALIVA treatment in primary biliary cholangitis (PBC) patients with either
compensated or decompensated cirrhosis.
• OCALIVA is contraindicated in PBC patients with decompensated cirrhosis, a prior
decompensation event, or with compensated cirrhosis who have evidence of portal hypertension.
• Permanently discontinue OCALIVA in patients who develop laboratory or clinical evidence of
hepatic decompensation; have compensated cirrhosis and develop evidence of portal hypertension;
or experience clinically significant hepatic adverse reactions while on treatment
Case No. 03; New application for registration of drugs on Form 5-F on export facilitation
72. Name, address of Applicant / Marketing M/s PharmEvo (Pvt) Ltd., Plot No. A-29,
Authorization Holder North Western Industrial Zone, Port
Qasim Karachi
Name, address of Manufacturing site. M/s PharmEvo (Pvt) Ltd., Plot No. A-29,
North Western Industrial Zone, Port
Qasim Karachi
☐ Importer
☐ Is involved in none of the above
(contract giver)
☐ Export sale
(Deposit slip#3477572439)
The proposed proprietary name / brand Trilin XR 25+5+1000mg Tablet
name
Pharmaceutical ingredient (API) per unit Empagliflozin ………… 25mg
Linagliptin ……………. 5mg
Metformin HCl as extended release ….
1000mg
Pharmacotherapeutic Group of (API) Anti-Diabetic (Type II)
Reference to Finished product Innovator Specification
specifications
Proposed unit price 7’s, 10’s, 14’s, 20’s, 21’s, 28’s, 30’s,
56’s, 84’s, 100’s, 122’s
The status in reference regulatory TRIJARDY XR (5mg;2.5mg;1gm/
authorities 10mg;5mg;1gm/ 12.5mg;2.5mg;1gm/
25mg;5mg;1gm) film coated tablet by
M/s Boehringer Ingelheim
Pharmaceuticals, USFDA Approved.
GMP status of the Finished product GMP certificate issued 17th September,
manufacturer 2020 based on inspection conducted on
16th September 2020.
Name and address of API manufacturer. Empagliflozin:
M/s Jiangsu Yongan Pharmaceutical
CO., Ltd., No. 18, 237 Provincial Road,
Economic Development Zone, Huaian,
Jiangsu China
Linagliptin:
Jiangsu China
Metformin HCl:
M/s Shouguang Fukang Pharmaceutical
Co., Ltd., North-East of Dongwaihuan
Road, Dongcheng Industrial Area, China
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO
QOS-PD template. Summarized
information related to nomenclature,
physical form, manufacturers,
controls, impurities, specifications,
analytical procedures and its verification,
batch analysis and justification of
specification, reference standard,
container closure system and stability
studies of drug substance and drug
Module III (Drug Substance) The firm has submitted detail of
nomenclature, structure, general
specifications, analytical procedures and
its verification, batch analysis and
Empagliflozin as per zone IV-A.
conditions; 30°C ± 2°C / 65% ± 5%RH
for 36 months and at Accelerated
for 12 months
Batches: (130701, 130702, 130801)
Linagliptin:
Linagliptin as per zone IV-A. Stability
study is conducted at Real time
for 06 months
Batches: (20180201,20180202,
20180301)
Metformin HCl:
Metformin HCl as per zone IV-A.
for 06 months
Batches: (A-72611405016, A-
72611405017, A-72611405018)
specifications, analytical procedure and
its validation studies, batch analysis and
stability studies of drug product.
Pharmaceutical equivalence and Pharmaceutical Equivalence have been
comparative dissolution profile established against the innovator that is
TRIJARDY XR 25+5+1000mg Tablet
by M/s Boehringer Ingelheim
Pharmaceutical Inc. by performing
quality tests (Identification, Assay,
Dissolution, content uniformity).
CDP has been performed against the
same brand that is Trijardy XR
25+5+1000mg Tablet by M/s Boehringer
Ingelheim Pharmaceutical Inc. in Acid
media (pH 1.2), Acetate Buffer (pH 4.5)
& Phosphate Buffer (pH 6.8). The values
for f1 and f2 are in the acceptable range.
Analytical method validation/verification Firm has submitted method validation
of product studies including linearity, range,
accuracy, precision, repeatability,
robustness.
M/s Jiangsu Yongan Pharmaceutical CO., Ltd., No.
18, 237 Provincial Road, Economic Development
Zone, Huaian, Jiangsu China
Linagliptin:
Metformin HCl:
M/s Shouguang Fukang Pharmaceutical Co., Ltd.,
North-East of Dongwaihuan Road, Dongcheng
Industrial Area, China
Linagliptin: 7700-20200501
Metformin HCl: A-15212005110
Batch No. 21PD- 21PD-3550-04-T 21PD-3551-05-T
3549-03-
T
Date of Initiation 12-03- 12-03-2021 12-03-2021
2021
No. of Batches 03
1. Reference of previous approval of The firm has referred to previous
applications with stability study data of the inspection for authenticity of stability
firm (if any) data of their product conducted by the
panel on the basis of which Registration
Board in 293rd meeting dated 6th-8th
January, 2020 decided to approve
registration of Empagin XR Tablets
5/1000mg, Empagin XR Tablets
12.5/1000mg, Empagin XR Tablets
25/1000mg.
• The HPLC software is 21 CFR
compliant as per record available with
the firm.
available.
The firm has 16 stability chambers, 02 for
testing. All chambers are properly
qualified. All chambers are provided with
continuous power supply and data
loggers for continuous monitoring.
2. Approval of API/ DML/GMP certificate of Empagliflozin and Linagliptin:
API manufacturer issued by concerned Firm has submitted copy of GMP
regulatory authority of country of origin. certificate in the name of M/s Jiangsu
Yongan Pharmaceutical CO., Ltd., No.
18, 237 Provincial Road, Economic
Development Zone, Huaian, Jiangsu
China issued by Huaian Pharmaceutical
Chaoyang Road, Qingpu Industrial
Park, Huaian, Jiangsu valid upto 14-01-
2024.
Metformin HCl:
Firm has submitted copy of GMP
certificate in the name of M/s Shouguang
Fukang Pharmaceutical Co., Ltd., North-
East of Dongwaihuan Road, Dongcheng
Industrial Area, Shandong Province
China issued by Shandong Food and
Drug Administration valid upto 12-03-
2024.
import of 15kg of Empagliflozin in name
of M/s PharmEvo (Pvt) Ltd attested by
AD (I&E) DRAP Karachi dated 30-07-
2020.
Linagliptin:
ZY20060101G/W dated 01-06-2020 for
import of 0.5kg of Linagliptin in name of
M/s PharmEvo (Pvt) Ltd attested by AD
Metformin HCl:
20FK04Z4133B dated 10-08-2020 for
import of 10000kg of Metformin HCl in
name of M/s PharmEvo (Pvt) Ltd attested
by AD (I&E) DRAP Karachi dated 26-
08-2020.
4. Data of stability batches will be supported Fir has submitted data of stability batches
by attested respective documents like supported by attested respective
chromatograms, Raw data sheets, COA, documents like chromatograms, Raw
summary data sheets etc. data sheets, COA, summary data sheets
etc.
5. Compliance Record of HPLC software Compliance Record of HPLC software
21CFR & audit trail reports on product 21CFR & audit trail reports on product
testing testing is submitted
6. Record of Digital data logger for Record of Digital data logger for
temperature and humidity monitoring of temperature and humidity monitoring of
stability chambers (real time and stability chambers (real time and
accelerated) accelerated) is submitted
Remarks of Evaluator : XI
• The firm submitted that 10 % excess is included in the drug substances (Empagliflozin & Linagliptin)
to compensate process loss during active coating
• The firm submitted that Seal coting and film coating materials contain 25% excess to compensate
process loss
1.6.5 • Valid GMP certificate / DML of drug • Firm has again submitted copy of
substance manufacturer for GMP certificate in the name of M/s
empagliflozin and Linagliptin issued Jiangsu Yongan Pharmaceutical CO.,
by relevant regulatory authority of Ltd., No. 18, 237 Provincial Road,
country of origin is required Economic Development Zone,
Huaian, Jiangsu China issued by
Association No. 168, West Chaoyang
Road, Qingpu Industrial Park,
Huaian, Jiangsu valid upto 14-01-
2024.
• The firm has also submitted DML #
(Su 20160324) of M/s Jiangsu Yongan
Provincial Road, Economic
China valid upto December 06, 2025.
2.3.R.1 • Provide copy of Batch Firm has submitted copy of Batch
Manufacturing Record (BMR) for all Manufacturing Record (BMR) for all
the batches of drug product for which the batches of drug product for which
stability studies data is provided in stability studies data is performed.
Module 3 section 3.2.P.8.3>
3.2.S.4 • Copies of the Drug substance • Copies of the Drug substance
specifications and analytical specifications and analytical
procedures used for routine testing of procedures used for routine testing of
the Drug substance Empagliflozin, the Drug Substance Metformin HCl,
Linagliptin and Metformin HCl by Empagliflozin & Linaglitpin by drug
Drug Product manufacturer is product manufacturer is submitted.
required. • Analytical Method Verification
• Analytical Method Verification studies including specificity, accuracy
studies including specificity, and repeatability (method precision)
accuracy and repeatability (method performed by the Drug Product
precision) performed by the Drug manufacturer for drug substance(s)
Product manufacturer for drug Empagliflozin, Linagliptin and
substance(s) Empagliflozin, Metformin HCl is submitted.
Linagliptin and Metformin HCl shall
be submitted.
3.2S.7 • Submit stability study data for Firm has submitted stability study data
metformin HCl drug substance as per of Metformin HCl. Stability study is
zone-IV-A conditions conducted at Real time conditions; 30°C
± 2°C / 75% ± 5%RH for 36 months and
at Accelerated conditions; 40°C ± 2°C /
75% ± 5%RH for 06 months
Batches: (A-71411711073, A-
71411711074, A-71411711075)
3.2.P.2.2.1 • Justify why the pharmaceutical Firm submitted that complete testing has
equivalence study does not include been done while performing
complete testing of the drug product Pharmaceutical Equivalence test
and the innovator/comparator product includes Appearance, Identification,
including the tests recommended by Average weight, Assay, Dissolution,
innovator product. (arginine content, Content Uniformity and impurities.
water content) Furthermore, Arginine used in
formulation was considered as an
excipient previously. In accordance with
the innovator product, we have now
performed arginine content, and
supporting data is submitted
3.2.P.5 • Justification is required for not • The firm submitted that Arginine used
including test for arginine content in in formulation was considered as an
specification as recommended by excipient previously. In accordance
innovator product review document with the innovator product, we have
• In dissolution method only 2hr, 4hr now performed arginine content, and
and 12 are considered for dissolution submitted revised specifications and
of metformin HCl instead of 1, 2, 4, analytical record for determination of
6, 8, 10 and 12 hours as recommended arginine content.
by USFDA dissolution data base • In accordance with the chemistry
• Specificity test is not performed in review, application number
method validation studies 212614Orig1s000, Center for Drug
• Justification is required for not Evaluation and Research
performing test for arginine content in recommended the acceptable criteria
batch analysis as recommended by for metformin HCl are as 2 hour, 4
innovator product review document hour, and 12 hours.
Please refer below details:
Review Summary:
Empagliflozin
Q= in 45
minutes
Approved Linagliptin
dissolution Q= in 30
acceptance minutes
criteria Metformin HCl
2 hours:
4 hours:
12 hours: NLT
• The firm submitted that specificity test

has been performed in validation
studies covered under accuracy test in
method validation.
• The firm submitted that Arginine used
in formulation was considered as an
excipient previously. In accordance
with the innovator product, we have
now performed arginine content, and
submitted revised specifications and
analytical record for determination of
arginine content.
3.2.P.8 • Clarification is required since Registration Board was apprised that
stability study is performed as per delay of one month in drug product
given dates 09-03-2021 (initial time testing from the due tine point of
point), 28-06-2021 (03 months), 05- stability studies is permissible as stated
10-2021 (07 months) which is in the FAQs published on DRAP’s
different from that recommended by website
ICH guidelines.
specifications, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
73. Name, address of Applicant / Marketing Authorization M/s PharmEvo (Pvt) Ltd., Plot No.
Holder A-29, North Western Industrial
Zone, Port Qasim Karachi
Name, address of Manufacturing site. M/s PharmEvo (Pvt) Ltd., Plot No.
A-29, North Western Industrial
Zone, Port Qasim Karachi
☐ Importer
(contract giver)
☐ Export sale
The proposed proprietary name / brand name Trilin XR 5+2.5+1000mg Tablet
Linagliptin ……………. 2.5mg
Metformin HCl as extended
release …. 1000mg
Reference to Finished product specifications Innovator Specification
Proposed unit price 7’s, 10’s, 14’s, 20’s, 21’s, 28’s,
30’s, 56’s, 84’s, 100’s, 122’s
The status in reference regulatory authorities TRIJARDY XR
(5mg;2.5mg;1gm/
10mg;5mg;1gm/
12.5mg;2.5mg;1gm/
25mg;5mg;1gm) film coated
tablet by M/s Boehringer
Ingelheim Pharmaceuticals,
USFDA Approved.
GMP status of the Finished product manufacturer GMP certificate issued 17th
September, 2020 based on
inspection conducted on 16th
September 2020.
M/s Jiangsu Yongan
Pharmaceutical CO., Ltd., No. 18,
Development Zone, Huaian,
Jiangsu China
Linagliptin:
M/s Jiangsu Yongan
Pharmaceutical CO., Ltd., No. 18,
Development Zone, Huaian,
Jiangsu China
Metformin HCl:
M/s Smruthi Organics Limited.,
Plot No. A-27, M.I.D.C.,
Chincholi, Taluka: Mohol,
Solapur, Maharashtra, India
Module-II (Quality Overall Summary) Firm has submitted QOS as per
WHO QOS-PD template.
Summarized information related
to nomenclature, structure, general
properties, solubilities, physical
form, manufacturers, description
of manufacturing process and
controls, impurities,
specifications, analytical
procedures and its verification,
container closure system and
properties, solubilities, physical
form, manufacturers, description
of manufacturing process and
controls, specifications, analytical
procedures and its verification,
container closure system and
Firm has submitted stability study
data of Empagliflozin as per zone
IV-A. Stability study is conducted
at Real time conditions; 30°C ±
and at Accelerated conditions;
40°C ± 2°C / 75% ± 5%RH for 12
months
Batches: (130701, 130702,
130801)
Linagliptin:
data of Linagliptin as per zone IV-
A. Stability study is conducted at
Real time conditions; 30°C ± 2°C /
65% ± 5%RH for 36 months and
at Accelerated conditions; 40°C ±
Batches: (20180201,20180202,
20180301)
Metformin HCl:
data of Metformin HCl as per zone
IV-A. Stability study is conducted
at Real time conditions; 30°C ±
and at Accelerated conditions;
40°C ± 2°C / 75% ± 5%RH for 06
months
Batches: (MFH-352/04, MFH-
353/04, MFH-354/04,)
manufacturing process and
controls, specifications, analytical
procedure and its validation
studies, batch analysis and
justification of specification,
reference standard, container
closure system and stability
studies of drug product.
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence have
dissolution profile been established against the
innovator that is TRIJARDY XR
5+2.5+1000mg Tablet by M/s
Boehringer Ingelheim
Pharmaceutical Inc. by
performing quality tests
(Identification, Assay,
CDP has been performed against
the same brand that is Trijardy XR
5+2.5+1000mg Tablet by M/s
Boehringer Ingelheim
Pharmaceutical Inc. in Acid media
(pH 1.2), Acetate Buffer (pH 4.5)
& Phosphate Buffer (pH 6.8). The
values for f1 and f2 are in the
acceptable range.
Analytical method validation/verification of product Firm has submitted method
validation studies including
linearity, range, accuracy,
precision, repeatability,
robustness.
M/s Jiangsu Yongan Pharmaceutical CO., Ltd., No. 18,
237 Provincial Road, Economic Development Zone,
Huaian, Jiangsu China
Linagliptin:
M/s Jiangsu Yongan Pharmaceutical CO., Ltd., No. 18,
237 Provincial Road, Economic Development Zone,
Huaian, Jiangsu China
Metformin HCl:
M/s Smruthi Organics Limited., Plot No. A-27, M.I.D.C.,
Chincholi, Taluka: Mohol, Solapur, Maharashtra, India
Metformin HCl: MET-0105/21
Batch No. 21PD-3681-02-T 21PD-3682-03- 21PD-3683-04-
T T
No. of Batches 03
7. Reference of previous approval of applications with The firm has referred to previous
stability study data of the firm (if any) inspection for authenticity of
stability data of their product
conducted by the panel on the
basis of which Registration Board
in 293rd meeting dated 6th-8th
registration of Empagin XR
Tablets 5/1000mg, Empagin XR
Tablets 10/1000mg, Empagin XR
Tablets 12.5/1000mg, Empagin
XR Tablets 25/1000mg.
Inspection date: 05th December,
2019
compliant as per record available
with the firm.
• Audit Trail on the testing reports
are available.
The firm has 16 stability
chambers, 02 for accelerated and
14 for real time stability testing.
All chambers are properly
qualified. All chambers are
provided with continuous power
supply and data loggers for
continuous monitoring.
8. Approval of API/ DML/GMP certificate of API Empagliflozin and Linagliptin:
manufacturer issued by concerned regulatory authority Firm has submitted copy of GMP
of country of origin. certificate in the name of M/s
Jiangsu Yongan Pharmaceutical
CO., Ltd., No. 18, 237 Provincial
Road, Economic Development
Industry Association No. 168,
West Chaoyang Road, Qingpu
Industrial Park, Huaian, Jiangsu
Metformin HCl:
certificate in the name of M/s
Smruthi Organics Limited., Plot
No. A-27, M.I.D.C., Chincholi,
Taluka: Mohol, Solapur,
Maharashtra, India issued by
Commissioner Food and Drug
Administration, Maharashtra State
India valid upto 13th November
2022.
9. Documents for the procurement of API with approval Empagliflozin:

from DRAP (in case of import). Firm has submitted copy of
invoice No. ZY20072302G/W
dated 23-07-2020 for import of
15kg of Empagliflozin in name of
M/s PharmEvo (Pvt) Ltd attested
by AD (I&E) DRAP Karachi dated
30-07-2020.
Linagliptin:
invoice No. ZY20060101G/W
dated 01-06-2020 for import of
0.5kg of Linagliptin in name of
M/s PharmEvo (Pvt) Ltd attested
by AD (I&E) DRAP Karachi dated
10-06-2020.
Metformin HCl:
invoice No. E-144 dated 15-02-
2021 for import of 10000kg of
Metformin HCl in name of M/s
PharmEvo (Pvt) Ltd attested by
AD (I&E) DRAP Karachi dated
08-03-2021.
10. Data of stability batches will be supported by attested Fir has submitted data of stability
respective documents like chromatograms, Raw data batches supported by attested
sheets, COA, summary data sheets etc. respective documents like
chromatograms, Raw data sheets,
11. Compliance Record of HPLC software 21CFR & audit Compliance Record of HPLC
trail reports on product testing software 21CFR & audit trail
reports on product testing is
submitted
12. Record of Digital data logger for temperature and Record of Digital data logger for
humidity monitoring of stability chambers (real time temperature and humidity
and accelerated) monitoring of stability chambers
(real time and accelerated) is
submitted
process loss
1.6.5 • Valid GMP certificate / DML of • Firm has again submitted copy of GMP
drug substance manufacturer for certificate in the name of M/s Jiangsu
empagliflozin and Linagliptin Yongan Pharmaceutical CO., Ltd., No.
issued by relevant regulatory 18, 237 Provincial Road, Economic
authority of country of origin is Development Zone, Huaian, Jiangsu
required China issued by Huaian
Pharmaceutical Industry Association
No. 168, West Chaoyang Road, Qingpu
Industrial Park, Huaian, Jiangsu valid
upto 14-01-2024.
Provincial Road, Economic
China valid upto December 06, 2025.
specifications and analytical specifications and analytical procedures
procedures used for routine testing used for routine testing of the Drug
of the Drug substance Substance Metformin HCl,
Empagliflozin, Linagliptin and Empagliflozin & Linaglitpin by drug
Metformin HCl by Drug Product product manufacturer is submitted.
manufacturer is required. • Analytical Method Verification studies
• Analytical Method Verification including specificity, accuracy and
studies including specificity, repeatability (method precision)
precision) performed by the Drug manufacturer for drug substance(s)
Product manufacturer for drug Empagliflozin, Linagliptin and
substance(s) Empagliflozin, Metformin HCl is submitted.
Linagliptin and Metformin HCl • The firm submitted that previously,
shall be submitted. USP-42 described the potentiometric
• Clarification is required as the drug titration method for metformin. The
substance manufacturer has same method was used for analysis, but
performed assay of drug substance in USP-43, the HPLC method is given.
Metformin HCl in batch analysis by Consequently, the potentiometric
potentiometric method and drug method is switched to the HPLC
product manufacturer has method. Verification studies for the
performed assay of drug substance HPLC method are submitted
Metformin HCl in batch analysis by • Firm has submitted COA of primary /
titrometric method instead of HPLC secondary reference standard including
method as recommended by USP. source and lot number for metformin
• COA of primary / secondary HCl
reference standard including source
and lot number for metformin HCl
shall be provided.
equivalence study does not include been done while performing
complete testing of the drug product Pharmaceutical Equivalence test includes
and the innovator/comparator Appearance, Identification, Average
product including the tests weight, Assay, Dissolution, Content
recommended by innovator Uniformity and impurities. Furthermore,
product. (arginine content, water Arginine used in formulation was
content) considered as an excipient previously. In
accordance with the innovator product,
we have now performed arginine content,
and supporting data is submitted
3.2.P.5 • Justification is required for not • The firm submitted that Arginine used
including test for arginine content in in formulation was considered as an
specification as recommended by excipient previously. In accordance with
innovator product review document the innovator product, we have now
• In dissolution method only 2hr, 4hr performed arginine content, and
and 12 are considered for submitted revised specifications and
dissolution of metformin HCl analytical record for determination of
instead of 1, 2, 4, 6, 8, 10 and 12 arginine content.
hours as recommended by USFDA • In accordance with the chemistry
dissolution data base review, application number
• Specificity test is not performed in 212614Orig1s000, Center for Drug
method validation studies Evaluation and Research recommended
• Justification is required for not the acceptable criteria for metformin
performing test for arginine content HCl are as 2 hour, 4 hour, and 12 hours.
in batch analysis as recommended Please refer below details:
by innovator product review Review Summary:
document Empagliflozin
Q= in 45
minutes
Approved Linagliptin
acceptance minutes
2 hours:
4 hours:
12 hours: NLT
• The firm submitted that specificity test

has been performed in validation studies
covered under accuracy test in method
validation.
• The firm submitted that Arginine used

in formulation was considered as an
excipient previously. In accordance with
the innovator product, we have now
performed arginine content, and
submitted revised specifications and
analytical record for determination of
arginine content.
3.2.P.8 • Clarification is required since The firm submitted that after completing
stability study is performed as per the initial study, product stability was
given dates 07-05-2021 (initial time charged on 07-05-2021. As per the
point), 10-10-2021 (05 months), defined interval, samples have to be tested
20-12-2021 (07 months) which is within one month according to SOP, but
different from that recommended by due to different gradient programming in
ICH guidelines. the method, there were different tests that
needed to be performed according to the
method and the compilation of data,
which caused delays in the completion of
testing of stability batches.
Furthermore, the stability study results at
both conditions, long term and
accelerated, are well within specification,
showing that the product was properly
stored and no effect observed due to this
delay in time period of stability testing.
Moreover, we assure that all testing of
stability batches will be tested on time as
per the recommendation of the ICH
guideline.
Registration Board was apprised that
delay of one month in drug product testing
from the due tine point of stability studies
is permissible as stated in the FAQs
published on DRAP website
Qasim Karachi
Qasim Karachi
☐ Importer
(contract giver)
☐ Export sale
The proposed proprietary name / brand name Trilin XR 10+5+1000mg Tablet
Linagliptin ……………. 5mg
1000mg
56’s, 84’s, 100’s, 122’s
The status in reference regulatory authorities TRIJARDY XR (5mg;2.5mg;1gm/
10mg;5mg;1gm/ 12.5mg;2.5mg;1gm/
GMP status of the Finished product manufacturer GMP certificate issued 17th September,
2020 based on inspection conducted on
Jiangsu China
Linagliptin:
Jiangsu China
Metformin HCl:
M/s Smruthi Organics Limited., Plot No.
A-27, M.I.D.C., Chincholi, Taluka:
Mohol, Solapur, Maharashtra, India
for 12 months
Batches: (130701, 130702, 130801)
Linagliptin:
for 06 months
Batches: (20180201,20180202,
20180301)
Metformin HCl:
for 06 months
Batches: (MFH-352/04, MFH-353/04,
MFH-354/04,)
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence have been
dissolution profile established against the innovator that is
TRIJARDY XR 10+5+1000mg Tablet
by M/s Boehringer Ingelheim
10+5+1000mg Tablet by M/s Boehringer
Ingelheim Pharmaceutical Inc. in Acid
media (pH 1.2), Acetate Buffer (pH 4.5)
& Phosphate Buffer (pH 6.8). The values
Analytical method validation/verification of Firm has submitted method validation
product studies including linearity, range,
robustness.
M/s Jiangsu Yongan Pharmaceutical CO., Ltd., No. 18, 237
Provincial Road, Economic Development Zone, Huaian,
Jiangsu China
Linagliptin:
M/s Jiangsu Yongan Pharmaceutical CO., Ltd., No. 18, 237
Provincial Road, Economic Development Zone, Huaian,
Jiangsu China
Metformin HCl:
M/s Smruthi Organics Limited., Plot No. A-27, M.I.D.C.,
Chincholi, Taluka: Mohol, Solapur, Maharashtra, India
No. of Batches 03
1. Reference of previous approval of applications The firm has referred to previous
with stability study data of the firm (if any) inspection for authenticity of stability
data of their product conducted by the
25/1000mg.
the firm.
available.
manufacturer issued by concerned regulatory Firm has submitted copy of GMP
authority of country of origin. certificate in the name of M/s Jiangsu
2024.
Metformin HCl:
certificate in the name of M/s Smruthi
Organics Limited., Plot No. A-27,
M.I.D.C., Chincholi, Taluka: Mohol,
Solapur, Maharashtra, India issued by
Administration, Maharashtra State India
valid upto 13th November 2022.
3. Documents for the procurement of API with Empagliflozin:
approval from DRAP (in case of import). Firm has submitted copy of invoice No.
ZY20072302G/W dated 23-07-2020 for
2020.
Linagliptin:
ZY20060101G/W dated 01-06-2020 for
Metformin HCl:
E-144 dated 15-02-2021 for import of
10000kg of Metformin HCl in name of
4. Data of stability batches will be supported by Fir has submitted data of stability batches
attested respective documents like chromatograms, supported by attested respective
Raw data sheets, COA, summary data sheets etc. documents like chromatograms, Raw
etc.
5. Compliance Record of HPLC software 21CFR & Compliance Record of HPLC software
audit trail reports on product testing 21CFR & audit trail reports on product
testing is submitted
humidity monitoring of stability chambers (real temperature and humidity monitoring of
time and accelerated) stability chambers (real time and
accelerated) is submitted
process loss
1.6.5 • Valid GMP certificate / DML • Firm has again submitted copy of GMP
of drug substance manufacturer certificate in the name of M/s Jiangsu
for empagliflozin and Yongan Pharmaceutical CO., Ltd., No. 18,
Linagliptin issued by relevant 237 Provincial Road, Economic
regulatory authority of country Development Zone, Huaian, Jiangsu China
of origin is required issued by Huaian Pharmaceutical Industry
December 06, 2025.
3.2.S.4 • Copies of the Drug substance • Copies of the Drug substance specifications
specifications and analytical and analytical procedures used for routine
procedures used for routine testing of the Drug Substance Metformin
testing of the Drug substance HCl, Empagliflozin & Linaglitpin by drug
Empagliflozin, Linagliptin and product manufacturer is submitted.
Metformin HCl by Drug • Analytical Method Verification studies
Product manufacturer is including specificity, accuracy and
required. repeatability (method precision) performed
• Analytical Method Verification by the Drug Product manufacturer for drug
studies including specificity, substance(s) Empagliflozin, Linagliptin and
accuracy and repeatability Metformin HCl is submitted.
(method precision) performed • The firm submitted that previously, USP-42
by the Drug Product described the potentiometric titration
manufacturer for drug method for metformin. The same method
substance(s) Empagliflozin, was used for analysis, but in USP-43, the
Linagliptin and Metformin HCl HPLC method is given. Consequently, the
shall be submitted. potentiometric method is switched to the
• Clarification is required as the HPLC method. Verification studies for the
drug substance manufacturer HPLC method are submitted
has performed assay of drug • Firm has submitted COA of primary /
substance Metformin HCl in secondary reference standard including
batch analysis by source and lot number for metformin HCl
potentiometric method and drug
product manufacturer has
performed assay of drug
substance Metformin HCl in
batch analysis by titrometric
method instead of HPLC
method as recommended by
USP.
• COA of primary / secondary
reference standard including
source and lot number for
metformin HCl shall be
provided.
3.2.P.2.2.1 • Justify why the pharmaceutical Firm submitted that complete testing has been
equivalence study does not done while performing Pharmaceutical
include complete testing of the Equivalence test includes Appearance,
drug product and the Identification, Average weight, Assay,
innovator/comparator product Dissolution, Content Uniformity and
including the tests impurities. Furthermore, Arginine used in
recommended by innovator formulation was considered as an excipient
product. (arginine content, previously. In accordance with the innovator
water content) product, we have now performed arginine
content, and supporting data is submitted
3.2.P.5 • Justification is required for not • The firm submitted that Arginine used in
including test for arginine formulation was considered as an excipient
content in specification as previously. In accordance with the innovator
recommended by innovator product, we have now performed arginine
product review document content, and submitted revised
• In dissolution method only 2hr, specifications and analytical record for
4hr and 12 are considered for determination of arginine content.
dissolution of metformin HCl • In accordance with the chemistry review,
instead of 1, 2, 4, 6, 8, 10 and 12 application number 212614Orig1s000,
hours as recommended by Center for Drug Evaluation and Research
USFDA dissolution data base recommended the acceptable criteria for
• Specificity test is not performed metformin HCl are as 2 hour, 4 hour, and 12
in method validation studies hours.
• Justification is required for not Please refer below details:
performing test for not Review Summary:
performing test for arginine Empagliflozin
content in batch analysis as Q= in 45
recommended by innovator minutes
product review document Approved Linagliptin
acceptance minutes
2 hours:
4 hours:
12 hours: NLT
• The firm submitted that specificity test has

been performed in validation studies
validation.
• The firm submitted that Arginine used in
formulation was considered as an excipient
previously. In accordance with the innovator
product, we have now performed arginine
content, and submitted revised
specifications and analytical record for
determination of arginine content.
3.2.P.8 • Clarification is required since The firm submitted that after completing the
stability study is performed as initial study, product stability was charged on
per given dates 05-07-2021 05-07-2021. As per the defined interval,
(initial time point), 20-12-2021 samples have to be tested within one month
(05 months), 03-02-2022 (07 according to SOP, but due to different
months) which is different from gradient programming in the method, there
that recommended by ICH were different tests that needed to be
guidelines. performed according to the method and the
compilation of data, which caused delays in
the completion of testing of stability batches.
Furthermore, the stability study results at both
conditions, long term and accelerated, are
well within specification, showing that the
product was properly stored and no effect
observed due to this delay in time period of
stability testing. Moreover, we assure that all
testing of stability batches will be tested on
time as per the recommendation of the ICH
guideline.
• Registration Board directed the firm to optimize the formulation to minimise the overage of
“Active coating solution of Empagliflozin & Linagliptin” during commercial production.
Qasim Karachi
Qasim Karachi
☐ Importer
(contract giver)
☐ Export sale
The proposed proprietary name / brand name Trilin XR 12.5+2.5+1000mg Tablet
Pharmaceutical ingredient (API) per unit Empagliflozin ………… 12.5mg
Linagliptin ……………. 2.5mg
1000mg
56’s, 84’s, 100’s, 122’s
The status in reference regulatory authorities TRIJARDY XR (5mg;2.5mg;1gm/
10mg;5mg;1gm/ 12.5mg;2.5mg;1gm/
GMP status of the Finished product manufacturer GMP certificate issued 17th September,
2020 based on inspection conducted on
Jiangsu China
Linagliptin:
Jiangsu China
Metformin HCl:
M/s Smruthi Organics Limited., Plot No.
A-27, M.I.D.C., Chincholi, Taluka:
Mohol, Solapur, Maharashtra, India
for 12 months
Batches: (130701, 130702, 130801)
Linagliptin:
for 06 months
Batches: (20180201,20180202,
20180301)
Metformin HCl:
for 06 months
Batches: (MFH-352/04, MFH-353/04,
MFH-354/04,)
TRIJARDY XR 12.5+2.5+1000mg
Tablet by M/s Boehringer Ingelheim
12.5+2.5+1000mg Tablet by M/s
Boehringer Ingelheim Pharmaceutical
Inc. in Acid media (pH 1.2), Acetate
Buffer (pH 4.5) & Phosphate Buffer (pH
6.8). The values for f1 and f2 are in the
acceptable range.
product studies including linearity, range,
robustness.
Linagliptin:
Metformin HCl:
M/s Smruthi Organics Limited., Plot No. A-27,
M.I.D.C., Chincholi, Taluka: Mohol, Solapur,
Maharashtra, India
Batch No. 21PD- 21PD-3746-05-T 21PD-3747-06-T
3745-04-
T
2021
No. of Batches 03
25/1000mg.
the firm.
available.
manufacturer issued by concerned regulatory Firm has submitted copy of GMP
authority of country of origin. certificate in the name of M/s Jiangsu
2024.
Metformin HCl:
certificate in the name of M/s Smruthi
Organics Limited., Plot No. A-27,
M.I.D.C., Chincholi, Taluka: Mohol,
Solapur, Maharashtra, India issued by
Administration, Maharashtra State India
valid upto 13th November 2022.
3. Documents for the procurement of API with Empagliflozin:
approval from DRAP (in case of import). Firm has submitted copy of invoice No.
ZY20072302G/W dated 23-07-2020 for
2020.
Linagliptin:
ZY20060101G/W dated 01-06-2020 for
Metformin HCl:
E-144 dated 15-02-2021 for import of
10000kg of Metformin HCl in name of
attested respective documents like chromatograms, supported by attested respective
Raw data sheets, COA, summary data sheets etc. documents like chromatograms, Raw
etc.
humidity monitoring of stability chambers (real temperature and humidity monitoring of
time and accelerated) stability chambers (real time and
process loss
1.6.5 • Valid GMP certificate / DML of • Firm has again submitted copy of GMP
drug substance manufacturer for certificate in the name of M/s Jiangsu
empagliflozin and Linagliptin Yongan Pharmaceutical CO., Ltd., No. 18,
issued by relevant regulatory 237 Provincial Road, Economic
authority of country of origin is Development Zone, Huaian, Jiangsu China
required issued by Huaian Pharmaceutical
December 06, 2025.
procedures used for routine used for routine testing of the Drug
testing of the Drug substance Substance Metformin HCl, Empagliflozin
Empagliflozin, Linagliptin and & Linaglitpin by drug product
Metformin HCl by Drug Product manufacturer is submitted.
manufacturer is required. • Analytical Method Verification studies
studies including specificity, repeatability (method precision) performed
accuracy and repeatability by the Drug Product manufacturer for drug
(method precision) performed by substance(s) Empagliflozin, Linagliptin
the Drug Product manufacturer and Metformin HCl is submitted.
for drug substance(s) • The firm submitted that previously, USP-
Empagliflozin, Linagliptin and 42 described the potentiometric titration
Metformin HCl shall be method for metformin. The same method
submitted. was used for analysis, but in USP-43, the
• Clarification is required as the HPLC method is given. Consequently, the
drug substance manufacturer has potentiometric method is switched to the
performed assay of drug HPLC method. Verification studies for the
substance Metformin HCl in HPLC method are submitted
batch analysis by potentiometric • Firm has submitted COA of primary /
method and drug product secondary reference standard including
manufacturer has performed source and lot number for metformin HCl
assay of drug substance
Metformin HCl in batch analysis
by titrometric method instead of
HPLC method as recommended
by USP.
• COA of primary / secondary
metformin HCl shall be
provided.
equivalence study does not been done while performing Pharmaceutical
include complete testing of the Equivalence test includes Appearance,
drug product and the Identification, Average weight, Assay,
innovator/comparator product Dissolution, Content Uniformity and
including the tests recommended impurities. Furthermore, Arginine used in
by innovator product. (arginine formulation was considered as an excipient
content, water content) previously. In accordance with the innovator
product, we have now performed arginine
content, and supporting data is submitted
3.2.P.5 • Justification is required for not • The firm submitted that Arginine used in
including test for arginine formulation was considered as an excipient
content in specification as previously. In accordance with the
recommended by innovator innovator product, we have now performed
product review document arginine content, and submitted revised
• In dissolution method only 2hr, specifications and analytical record for
4hr and 12 are considered for determination of arginine content.
dissolution of metformin HCl • In accordance with the chemistry review,
instead of 1, 2, 4, 6, 8, 10 and 12 application number 212614Orig1s000,
Center for Drug Evaluation and Research
hours as recommended by recommended the acceptable criteria for
USFDA dissolution data base metformin HCl are as 2 hour, 4 hour, and
• Specificity test is not performed 12 hours.
in method validation studies Please refer below details:
• Justification is required for not Review Summary:
performing test for arginine Empagliflozin
content in batch analysis as Q= in 45
recommended by innovator minutes
product review document Approved Linagliptin
acceptance minutes
2 hours:
4 hours:
12 hours: NLT
• The firm submitted that specificity test has

been performed in validation studies
validation.
• The firm submitted that Arginine used in

formulation was considered as an excipient
previously. In accordance with the
innovator product, we have now performed
arginine content, and submitted revised
specifications and analytical record for
determination of arginine content.
3.2.P.8 • Clarification is required since The firm submitted that after completing the
stability study is performed as initial study, product stability was charged
per given dates 04-08-2021 on 04-08-2021. As per the defined interval,
(initial time point), 20-12-2021 samples have to be tested within one month
(04 months), 06-03-2022 (07 according to SOP, but due to different
months) submitted which is gradient programming in the method, there
different from that recommended were different tests that needed to be
by ICH guidelines. performed according to the method and the
compilation of data, which caused delays in
the completion of testing of stability batches.
Furthermore, the stability study results at
both conditions, long term and accelerated,
are well within specification, showing that
the product was properly stored and no effect
observed due to this delay in time period of
stability testing. Moreover, we assure that all
testing of stability batches will be tested on
time as per the recommendation of the ICH
guideline.
• The Registration Board directed the firm to optimize the formulation to minimise the overage
of “Active coating solution of Empagliflozin & Linagliptin” during commercial production.
76. Name, address of Applicant / Marketing M/s Macter International Limited., F-
Authorization Holder 216, S.I.T.E Karachi
Name, address of Manufacturing site. M/s Macter International Limited., F-
216, S.I.T.E Karachi
☐ Importer
(contract giver)
☐ Export sale
Dy. No. and date of submission Dy.No 18584 dated 27-06-2022
Details of fee submitted Rs.50,000/- dated 17-03-2021 &
Rs.25,000/- dated 13-07-2021
The proposed proprietary name / brand name Ticago 90mg Tablet
Strength / concentration of drug of Active Each Film Coated Tablet Contains:
Pharmaceutical ingredient (API) per unit Ticagrelor……………….…90mg
Pharmacotherapeutic Group of (API) Platelet aggregation inhibitors excl.
heparin
Reference to Finished product specifications N/A
Proposed unit price 10’s, 14’s, 28’s
The status in reference regulatory authorities BRILINTA (90mg, 60mgelor) film
coated tablet USFDA Approved.
For generic drugs (me-too status) Briltiga 90mg Tablet by M/s Global
GMP status of the Finished product GMP certificate issued to firm date 13th
manufacturer August, 2020 based on inspection
conducted on 10th October 2019.
Name and address of API manufacturer. Manufacturer:
M/s Nantong Chanyoo Pharmatech CO.,
Ltd., No.2 Tonghai Si Road, Yangkou
Chemical Industrial Park, Rudong
Coastal Economic Development Zone,
Nantong, Jiangso Province 226407, P.R.
China
DMF Holder/Headquarter:
Changzhou Pharmaceutical Factory., No.
518 Laodong East Road, Changzhou,
Province, China
Stability studies Firm has submitted stability study data of
Ticagrelor. Stability study is conducted
Batches: (140901, 141001, 141101)
Stability study data conducted at Real
time conditions; 30°C ± 2°C / 65% ±
5%RH for 24 months is submitted for
following batches.
Batches: RD-TG-201806261, RD-TG-
201808021, RD-TG-201810081
**Stability study data of different
batches at real time and accelerated
conditions is submitted
justification of specification, container
closure system and stability studies of
drug product.
Brilinta 90mg Tablet by M/s
AstraZeneca Pharma Sweden by
performing quality tests (Identification,
Assay, Dissolution, average weight of
tablet).
same brand that is Brilinta 90mg Tablet
by M/s AstraZeneca Pharma Sweden in
Acid media (pH 1.2), Acetate Buffer (pH
4.5) & Phosphate Buffer (pH 6.8) and
0.2% Tween 80 in water. The values for
f2 are in the acceptable range.
product studies including accuracy, linearity,
precision (i.e. repeatability and
intermediate precision), specificity,
robustness and solution stability.
Manufacturer of API Manufacturer:
M/s Nantong Chanyoo Pharmatech CO., Ltd., No.2
Tonghai Si Road, Yangkou Chemical Industrial Park,
Rudong Coastal Economic Development Zone,
Nantong, Jiangso Province 226407, P.R. China
Changzhou Pharmaceutical Factory., No. 518
Laodong East Road, Changzhou, Province, China
API Lot No. RD-TG-201911261
Batch No. 20TB- 20TB-043-002 20TB-044-003
042-001
Manufacturing Date 20-03- 31-03-2020 31-03-2020
2020
2020
No. of Batches 03
Board in 296th meeting dated 8th, 9th &
10th September, 2020 decided to approve
registration of Vireof-N 25mg Tablets.
the firm.
Tenofovir Alafenamide Fumarate API
and Vireof-N tablets 25mg is available.
The firm has adequate monitoring and
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP
manufacturer issued by concerned regulatory certificate in the name of M/s Nantong
authority of country of origin. Chanyoo Pharmatech CO., Ltd., No.2
Tonghai Si Road, Yangkou Chemical
Industrial Park, Rudong Coastal
Economic Development Zone, Nantong,
Jiangsu Province 226407, P.R. China
issued by Nantong Chemical & Medical
Industry Association China valid upto
05-05-2022.
3. Documents for the procurement of API with Firm has submitted copy of Form 6 dated
approval from DRAP (in case of import). 04-03-2020 for import of 02kg of
Ticagrelor in name of M/s Macter
International Ltd., attested by AD (I&E)
CY120039 dated 25-02-2020 for import
of 02kg of Ticagrelor in name of M/s
Macter International Ltd., attested by AD
(I&E) DRAP Karachi dated 04-03-2020
attested respective documents like supported by attested respective
etc.
6. Record of Digital data logger for temperature and Not submitted
humidity monitoring of stability chambers (real
1.3.5 • Latest GMP inspection report/ GMP Firm has submitted cGMP certificate
certificate of the manufacturing unit issued on 05th August 2022 based on
issued within the last three years shall inspection conducted on 04th August
be submitted 2022.
1.5.6 • You have not mentioned any The firm submitted that we have
specifications in this section while performed /develop and submitted its data
the official monograph is available in in 2020 at that time this molecule was not
BP. Revise your specification as per available in BP. It is now available in
BP monograph along with BP2022 and revised details in this section
submission of applicable fee are submitted. The firm has also
submitted Rs. 7500/- on deposit slip No#
9101119948 for revision of specifications
1.6.5 • Valid GMP certificate / DML of • Firm has submitted copy of GMP
drug substance manufacturer issued certificate in the name of M/s Nantong
by relevant regulatory authority of Chanyoo Pharmatech CO., Ltd., No.2
country of origin is required Tonghai Si Road, Yangkou Chemical
Economic Development Zone,
Nantong, Jiangsu Province 226407, P.R.
China issued by Nantong Chemical &
Medical Industry Association China
• Firm has submitted copy of DML (No.
Su 20160512) in the name of M/s
Nantong Chanyoo Pharmatech CO.,
Ltd., China issued by Jiangsu Provincial
Drug Administration China valid upto
02-12-2025.
3.2.S.4 • Manufacturer specification are • The firm submitted that at the time of
claimed for the drug substance by development 2020, the product was not
drug substance manufacturer while included in any official monograph
the official monograph is available in that’s why manufacturer provided data
BP. Justification shall be submitted. on manufacturer specification.
• Copies of the Drug substance • Copies of the Drug substance
procedures used for routine testing of used for routine testing of the Drug
the Drug substance /Active substance by Drug Product
Pharmaceutical Ingredient by Drug manufacturer is not submitted
Product manufacturer is required. • Analytical Method Verification studies
studies including specificity, repeatability (method precision)
precision) performed by the Drug manufacturer for drug substance is not
Product manufacturer for drug submitted.
substance(s) shall be submitted.
3.2.P.5.1 • This section has mentioned in-house • The firm has submitted revised
specifications while the official specifications and analytical procedure
monograph of the applied as BP monograph
formulation is available in BP. • The firm submitted that for limits of
Revise your specifications and dissolution and assay specifications,
analytical procedure as per BP testing method is revised along with the
monograph. limits of assay and dissolution.
• Justification is required since the • Method verification studies for applied
limits of submitted dissolution product as per BP method is not
specification and assay specification submitted
for shelf life provided by the drug
product manufacturer (NLT 75% Q
in 30 minutes, 90-110%) are different
from official BP monograph (Q =
70% after 45 minutes, 95-105%).
• Submit method verification studies
for applied product as per BP
monograph
3.2.P.6 • COA of primary / secondary • COA of primary / secondary reference
reference standard including source standard including source and lot
and lot number shall be provided. number is submitted
3.2.P.8 • Submit Record of Digital data logger • The firm has submitted Record of
for temperature and humidity Digital data logger for temperature and
monitoring of stability chambers humidity monitoring of stability
(real time and accelerated) chambers (real time and accelerated)
Decision: Approved with BP specifications.
• Registration letter will be issued upon submission of following:
o Specifications, analytical procedures and analytical method verification studies for both
drug substance and drug product as per BP monograph of Ticagrelor and Ticagrelor Tablet
respectively, from M/s Macter International Limited
o Fee of Rs. 7,500/- for correction/pre-approval change/ in product specifications, as per
77. Name, address of Applicant / Marketing M/s Macter International Limited., F-
Authorization Holder 216, S.I.T.E Karachi
Name, address of Manufacturing site. M/s Macter International Limited., F-
216, S.I.T.E Karachi
☐ Importer
(contract giver)
☐ Export sale
Details of fee submitted Rs.50,000/- dated 05-03-2021 &
Rs.25,000/- dated 13-07-2021
The proposed proprietary name / brand name Ticago 60mg Tablet
Strength / concentration of drug of Active Each Film Coated Tablet Contains:
Pharmaceutical ingredient (API) per unit Ticagrelor……………….…60mg
Pharmacotherapeutic Group of (API) Platelet aggregation inhibitors excl.
heparin
Reference to Finished product specifications N/A
Proposed unit price 10’s, 14’s, 28’s
The status in reference regulatory authorities BRILINTA (90mg, 60mgelor) film
coated tablet USFDA Approved.
For generic drugs (me-too status) Briltiga 60mg Tablet by M/s Global
GMP status of the Finished product GMP certificate issued to firm date 13th
manufacturer August, 2020 based on inspection
conducted on 10th October 2019.
Name and address of API manufacturer. Manufacturer:
M/s Nantong Chanyoo Pharmatech CO.,
Ltd., No.2 Tonghai Si Road, Yangkou
Chemical Industrial Park, Rudong
Coastal Economic Development Zone,
Nantong, Jiangso Province 226407, P.R.
China
Changzhou Pharmaceutical Factory., No.
518 Laodong East Road, Changzhou,
Province, China
Stability studies Firm has submitted stability study data of
Ticagrelor. Stability study is conducted
Batches: (140901, 141001, 141101)
Stability study data conducted at Real
time conditions; 30°C ± 2°C / 65% ±
5%RH for 24 months is submitted for
following batches.
Batches: RD-TG-201806261, RD-TG-
201808021, RD-TG-201810081
**Stability study data of different
conditions is submitted
drug product.
Brilinta 60mg Tablet by M/s
AstraZeneca Pharma Canada by
Assay, Dissolution, average weight of
tablet).
same brand that is Brilinta 60mg Tablet
by M/s AstraZeneca Pharma Canada in
Acid media (pH 1.2), Acetate Buffer (pH
4.5) & Phosphate Buffer (pH 6.8) and
0.2% Tween 80 in water. The values for
product studies including accuracy, linearity,
precision (i.e. repeatability and
intermediate precision), specificity,
robustness and solution stability.
Manufacturer of API Manufacturer:
M/s Nantong Chanyoo Pharmatech CO., Ltd., No.2
Tonghai Si Road, Yangkou Chemical Industrial Park,
Rudong Coastal Economic Development Zone,
Nantong, Jiangso Province 226407, P.R. China
Changzhou Pharmaceutical Factory., No. 518
Laodong East Road, Changzhou, Province, China
API Lot No. RD-TG-201911261
Batch No. 20TB- 20TB-032-002 20TB-033-003
031-001
Manufacturing Date 20-03- 31-03-2020 31-03-2020
2020
2020
No. of Batches 03
Board in 296th meeting dated 8th, 9th &
10th September, 2020 decided to approve
registration of Vireof-N 25mg Tablets.
the firm.
Tenofovir Alafenamide Fumarate API
and Vireof-N tablets 25mg is available.
The firm has adequate monitoring and
2. Approval of API/ DML/GMP certificate of API • Firm has submitted copy of GMP
manufacturer issued by concerned regulatory certificate in the name of M/s Nantong
authority of country of origin. Chanyoo Pharmatech CO., Ltd., No.2
Tonghai Si Road, Yangkou Chemical
Nantong, Jiangsu Province 226407,
P.R. China issued by Nantong
Chemical & Medical Industry
Association China valid upto 05-05-
2022.
• Firm has submitted copy of DML (No.
Su 20160512) in the name of M/s
Nantong Chanyoo Pharmatech CO.,
Ltd., China issued by Jiangsu Provincial
Drug Administration China valid upto
02-12-2025.
3. Documents for the procurement of API with Firm has submitted copy of Form 6 dated
approval from DRAP (in case of import). 04-03-2020 for import of 02kg of
Ticagrelor in name of M/s Macter
International Ltd., attested by AD (I&E)
CY120039 dated 25-02-2020 for import
of 02kg of Ticagrelor in name of M/s
Macter International Ltd., attested by AD
(I&E) DRAP Karachi dated 04-03-2020
attested respective documents like supported by attested respective
etc.
6. Record of Digital data logger for temperature and Not submitted
1.3.5 • Latest GMP inspection report/ GMP Firm has submitted cGMP certificate
certificate of the manufacturing unit issued on 05th August 2022 based on
issued within the last three years shall inspection conducted on 04th August
be submitted 2022.
1.5.6 • You have not mentioned any The firm submitted that we have
specifications in this section while the performed /develop and submitted its
official monograph is available in BP. data in 2020 at that time this molecule
Revise your specification as per BP was not available in BP. It is now
monograph along with submission of available in BP2022 and revised details
applicable fee in this section are submitted. The firm
has also submitted Rs. 7500/- on
deposit slip No# 97804485326 for
revision of specifications
1.6.5 • Valid GMP certificate / DML of drug Firm has submitted copy of GMP
substance manufacturer issued by certificate in the name of M/s Nantong
relevant regulatory authority of Chanyoo Pharmatech CO., Ltd., No.2
country of origin is required Tonghai Si Road, Yangkou Chemical
Nantong, Jiangsu Province 226407,
P.R. China issued by Nantong
Chemical & Medical Industry
Association China valid upto 21-02-
2026.
3.2.S.4 • Manufacturer specification are • The firm submitted that at the time of
claimed for the drug substance by drug development 2020, the product was
substance manufacturer while the not included in any official
official monograph is available in BP. monograph that’s why manufacturer
Justification shall be submitted. provided data on manufacturer
• Copies of the Drug substance specification.
specifications and analytical • Copies of the Drug substance
procedures used for routine testing of specifications and analytical
the Drug substance /Active procedures used for routine testing of
Pharmaceutical Ingredient by Drug the Drug substance by Drug Product
Product manufacturer is required. manufacturer is not submitted
• Analytical Method Verification • Analytical Method Verification
studies including specificity, accuracy studies including specificity,
and repeatability (method precision) accuracy and repeatability (method
performed by the Drug Product precision) performed by the Drug
manufacturer for drug substance(s) Product manufacturer for drug
shall be submitted. substance is not submitted.
3.2.P.5.1 • This section has mentioned in-house • The firm has submitted revised
specifications while the official specifications and analytical
monograph of the applied formulation procedure as BP monograph
is available in BP. Revise your • The firm submitted that for limits of
specifications and analytical procedure dissolution and assay specifications,
as per BP monograph. testing method is revised along with
• Justification is required since the the limits of assay and dissolution.
limits of submitted dissolution • Method verification studies for
specification and assay specification applied product as per BP method is
for shelf life provided by the drug not submitted
product manufacturer (NLT 75% Q in
30 minutes, 90-110%) are different
from official BP monograph (Q = 70%
after 45 minutes, 95-105%).
• Submit method verification studies for
applied product as per BP monograph
3.2.P.6 • COA of primary / secondary reference • COA of primary / secondary
standard including source and lot reference standard including source
number shall be provided. and lot number is submitted
3.2.P.8 • Submit Record of Digital data logger • The firm has submitted Record of
for temperature and humidity Digital data logger for temperature
monitoring of stability chambers (real and humidity monitoring of stability
time and accelerated) chambers (real time and accelerated)
Decision: Approved with BP specifications.
• Registration leter will be issued upon submission of following:
o Specifications, analytical procedures and analytical method verification studies for both
drug substance and drug product as per BP monograph of Ticagrelor and Ticagrelor Tablet
respectively, from M/s Macter International Limited
o Fee of Rs. 7,500/- for correction/pre-approval change/ in product specifications, as per
Case No. 04: Deferred cases of Human Drugs on form 5F (Local)

78. Name, address of Applicant / Marketing M/s Axis Pharmaceuticals., 3-B Value Addition
Authorization Holder City, 1.5 Km Khurrianwala – Sahianwala Road,
Faisalabad – Pakistan
Name, address of Manufacturing site. M/s Axis Pharmaceuticals., 3-B Value Addition
City, 1.5 Km Khurrianwala – Sahianwala Road,
Faisalabad – Pakistan
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. 25932 dated: 17-09-2021
Details of fee submitted PKR 30,000/-: 02-09-2021 (deposit slip #
977318003814)
The proposed proprietary name / brand Monticel Sachet 4mg
name
Strength / concentration of drug of Active Each sachet contains:
Pharmaceutical ingredient (API) per unit Montelukast (as Sodium)……………4mg
Pharmaceutical form of applied drug Powder for Oral use
Pharmacotherapeutic Group of (API) Leukotriene receptor antagonist
BP specification
specifications
Proposed Pack size 14’s and 28’s
The status in reference regulatory authorities Singulair (4mg) oral granules USFDA Approved
For generic drugs (me-too status) Myteka 4mg Sachet by M/s Hilton Pharma
(Reg#039695)
GMP status of the Finished product Firm has submitted GMP certificate issued on 06-
manufacturer 07-2020, based on inspection conducted on 09-06-
2020
Name and address of API manufacturer. Zhejiang Tianyu Pharmaceutical Co., Ltd., No.15,
Donghai 5th Avenue, Zhejiang Provincial
Chemical and Medical Raw Materials Base Linhai
Zone, Taizhou City, Zhejiang Province, China
317016
impurities, specifications, analytical procedures
and its verification, batch analysis and justification
of specification, reference standard, container
analytical procedures and its verification, batch
Stability studies Firm has submitted stability study data of 3
batches of API as per zone IV-A conditions
Stability study conditions:
Real time: 30°C ± 2°C / 65% ± 5%RH for 36
months
months
Batches: (11001-161001, 11001-161002, 11001-
161003)
impurities, specifications, analytical procedure
and its verification studies, batch analysis and
drug product.
Pharmaceutical equivalence and Firm has submitted results of pharmaceutical
comparative dissolution profile equivalence and comparative dissolution study
against the comparator product i.e. Myteka Sachet
4mg by M/s Hilton Pharma.
Pharmaceutical Equivalence have been conducted
by performing quality tests (Assay, Dissolution
and Uniformity of dosage form).
Results of CDP studies have been submitted
against the same brand in Pharmacopoeial Media
(0.5% SLS) only. Release of both the test and
reference product is more than 85% in hence no
calculation of f2 factor is required.
Analytical method validation/verification of Firm has submitted report of verification of
product analytical method for the drug product including
specificity, accuracy, and precision.
Manufacturer of API Zhejiang Tianyu Pharmaceutical Co., Ltd., No.15, Donghai 5th Avenue,
Zhejiang Provincial Chemical and Medical Raw Materials Base Linhai Zone,
Taizhou City, Zhejiang Province, China 317016
API Lot No. 11001-201005
Description of Pack Alu – Foil Sachet, packed in carton
(Container closure
system)
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. T-002 T-003 T-004
Batch Size 300 Sachet 500 Sachet 500 Sachet
No. of Batches 03
1. Reference of previous approval of Not submitted
firm (if any)
2. Approval of API/ DML/GMP certificate of The firm has submitted copy of GMP Certificate
API manufacturer issued by concerned of M/s Zhejiang Tianyu Pharmaceutical Co., Ltd.,
regulatory authority of country of origin. issued by China Food and Drug Administration
valid till 14-03-2023
3. Documents for the procurement of API with The firm has submitted copy of commercial
approval from DRAP (in case of import). invoice No#TYI21009 dated 29-12-2020 for
import of 60kg of Montelukast Sodium attested by
AD (I&E) DRAP Lahore.
4. Data of stability batches will be supported by Firm has submitted data of stability batches
attested respective documents like supported by attested respective documents like
chromatograms, Raw data sheets, COA, chromatograms, Raw data sheets, COA, summary
summary data sheets etc. data sheets etc.
5. Compliance Record of HPLC software Firm has submitted audit trail reports on product
21CFR & audit trail reports on product testing
testing
6. Record of Digital data logger for temperature Firm has submitted Record of Digital data logger
and humidity monitoring of stability for temperature and humidity monitoring of
chambers (real time and accelerated) stability chambers (real time)

3.2.S.4 • Drug substance manufacturer has • Analytical method and specifications of
stated USP specifications while montelukast sodium in both pharmacopeia
drug product manufacturer has (BP/USP) are same, therefore both
stated USP/BP specifications, standards are mentioned on COA. Evidence
clarify? is submitted.
• Analytical procedure of drug • Firm has submitted analytical procedure of
substance by drug substance drug substance by provided drug substance
manufacturer shall be submitted manufacturer
• You have mentioned the use of • The firm submitted that montelukast
Montelukast sodium working sodium is readily available as raw material
standard in analytical procedure and used as working standard in routine
during preparation of standard testing after standardization against
solution while pharmacopeia states montelukast dicyclohexylamine (reference
the use of montelukast standard).
dicyclohexylamine reference
standard, clarify?
3.2.S.5 Reference standard is montelukast Montelukast sodium (working standard) is
dicyclohexylamine while working used in routine testing, which is
standard is montelukast sodium, standardized against montelukast
clarify? dicyclohexylamine (reference standard).
3.2.P.2.1 • Clarification is required since the • The firm submitted that magnesium stearate
innovator product contain is routinely used as lubricant in oral solid
magnesium stearate in addition to dosage form to improve flow
other excipients while the applied characteristics of the product. The drug
product does not contain product is fine granular powder having
magnesium stearate. satisfactory flow characteristics without
• Justify why Pharmaceutical the use of magnesium stearate. Moreover,
equivalence of the applied product addition of magnesium stearate causes
has not been performed against the haziness in solution prepared after
innovator product? reconstitution as observed in product
• The results of comparative development phase. That is why, the said
dissolution profile conducted in excipient was not used.
three BCS media across the • Firm submitted that Pharmaceutical
physiological pH range along with equivalence of the applied product has been
calculation of similarity factor f2 performed against comparator product as
shall be submitted and discussed per DRAP’s guidance document (FAQs
about form 5F) dated 28-01-21.
• The firm submitted that comparative
dissolution profile has been conducted in
three BCS media (pH 1.2, 4.5 &6.8) and
already submitted pharmacopeial method
(0.5% SLS) & already submitted.
Montelukast sodium did not show any
response in the stated BCS media across
physiological range (pH 1.2, 4.5 & 6.8)
therefore it was not applicable to calculate
similarity factor in those media (firm has
submitted a few chromatograms for
evidence). However, in pharmacopeial
method both products showed more than
85% dissolution, therefore no calculation
was required.
3.2.P.3.2 The reference formulation states The firm submitted that the applied
granules for oral suspension for formulation is free flowing granular powder
applied formulation. and is completely soluble after reconstitution
Clarification is required in for use. API is geometrically mixed with
manufacturing process and process other excipients.
control whether granules will be
prepared in-house or otherwise.
3.2.P.5 • You have mentioned the use of The firm submitted that montelukast sodium
Montelukast sodium working is readily available as raw material and used
standard in analytical procedure as working standard in routine testing after
during preparation of standard standardization against montelukast
solution while pharmacopeia states dicyclohexylamine (reference standard).
the use of montelukast
dicyclohexylamine reference
standard, clarify?
3.2.P.6 Reference standard is montelukast Montelukast sodium (working standard) is
dicyclohexylamine while working used in routine testing, which is
standard is montelukast sodium, standardized against montelukast
clarify? dicyclohexylamine (reference standard).
3.2.P.8 • Submit 6th month stability study • Firm has submitted 6th month stability study
data at both real time and data at both real time and accelerated
accelerated conditions conditions
• Submit readable copy of • Firm has submitted readable copy of
commercial invoice commercial invoice
• Compliance Record of HPLC • The firm has submitted Compliance Record
software 21CFR shall be submitted of HPLC software 21CFR
• Submit Record of Digital data • Firm has submitted Record of Digital data
logger for temperature and logger for temperature and humidity
humidity monitoring of stability monitoring of stability chambers
chambers (accelerated conditions) (accelerated conditions)
Previous Decision (321-DRB): Deferred for Scientific justification for use of Montelukast sodium as
reference standard in analytical procedures instead of Montelukast dicyclohexylamine specified by BP
monograph.
Evaluation by PEC:
The firm submitted that Montelukast sodium (working standard) is used in routine testing, which is
standardized against Montelukast Dicyclohexylamine (reference standard) and submitted Evidence of
standardization.
Furthermore, analytical testing of the subjected drug product was performed at 18-month testing using
both standards i.e. Montelukast Sodium as well as Montelukast dicyclohexylamine to provide a
comparative examination. Analytical Testing Sheet attached herewith.
Result of the assay of all three stability trial batches (T-002, T-003 & T-004) are similar w.r.t. to both
standards and are summarized below;
Standard Weight Average % RSD Retention Tailing
Taken Area Time Factor
20.8 mg (eq.
Montelukast
to 20.0 mg 1746539.2 0.44 % 5.8 0.96
Sodium (WS)
Montelukast)
Montelukast 26.2 mg (eq.
Dicyclohexylamine to 20.0 mg 1751716.6 0.10 % 5.8 1.04
(RS) Montelukast)
Trial Weight Average Assay

Taken Area w.r.t. w.r.t.
Mont. Mont.
Sodium DCHA
T-002 500.2 mg 1799961.5 102.45 % 102.48 %
T-003 500.5 mg 1791612.5 101.88 % 101.91 %
T-004 500.4 mg 1805250.5 102.81 % 102.84 %
It can be clearly seen that irrespective of the standard used for analytical testing, the impact on the results
is negligible to none. Therefore, it is requested to you to kindly accept the stability data results w.r.t. to
montelukast sodium standard and approve registration of our drug product. Moreover, we will assure to
use Montelukast Dicyclohexylamine standard when commercialized.
Firm has submitted following details for procurmenet of USP reference standard of Montelukast
Dicyclohexylamine:
• Commercial invoice no. 34182376 from USP in name of M/s Axis Pharmaceuticals for
Montelukast Dicyclohexylamine (Catalogue# 1446815).
• Airway Bill
Decision: Approved.
79. Name, address of Applicant / ATCO Laboratories Limited., B-18, S.I.T.E., Karachi
Marketing Authorization Holder -7500, Pakistan
Name, address of Manufacturing site. ATCO Laboratories Limited., B-18, S.I.T.E., Karachi
-7500, Pakistan
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. 28455 Dated 15/ 10/ 2021
Details of fee submitted PKR 30,000/-: Dated 04/10/2021 (Deposit
Slip#03634033378)
The proposed proprietary name / brand Ondansetron Tablet 8mg
name
Active Pharmaceutical ingredient Ondansetron…………..8mg
(API) per unit (as Ondansetron Hydrochloride Dihydrate BP)
Pharmaceutical form of applied drug Film coated Tablet
Pharmacotherapeutic Group of (API) Antiemetics and antinauseants, Serotonin (5-HT3)
antagonists.
specifications
Proposed Pack size 7’s, 10’s, 14’s, 20’s, 28’s, 30’s.
authorities
For generic drugs (me-too status) Ongene 8mg Tablet by M/s High-Q Pharmaceuticals
(Reg#091207)
GMP status of the Finished product The firm was inspected on 22-03-2022 & 05-04-2022
manufacturer by the panel for renewal of DML, regularization of
section as per layout plan and additional sections and
decision of panel is:
Keeping in view the good facilities provided for
manufacturing and quality control of pharmaceutical
products registered in the name of firm being produced
at the site and overall good maintenance of plan and
the required documentation and SOPs, the panel
recommended the grand of DML of the firm as well as
regularization of sections as per layout plan and
approval of additional sections
Name and address of API M/s Anugraha Chemicals, No D-47 to D-50, C-62 and
manufacturer. C-63, KSSIDC, Industrial Estate, Doddaballapur,
of manufacturing process and controls, specifications,
of drug substance and drug product is submitted.
Module III (Drug Substance) The firm has submitted detail of manufacturers,
impurities, specifications, analytical procedure, batch
of drug substance.
Real time:30°C±2°C/75% ± 5%RH
Accelerated:40°C±2°C/75%±5%RH
Stability of all three batches at accelerated conditions
(AOND-17002, AOND-17003, AOND-17004)
conducted for 06 months
Real time stability study of two batches AOND-
17002, AOND-17003, conducted for 36 months while
real time stability study of one batch AOND-17004
verification studies, batch analysis and justification of
GlaxoSmithKline Research Triangle Park, NC
27709
Marketed by: Novartis Pharmaceuticals UK
Limited performing quality tests (Identification,
Assay, Dissolution, disintegration).
CDP of ondansetron 8mg tablets has been performed
against the zofran 8mg tablets in Acid media (pH 1.2),
acetate buffer (pH 4.5) & Phosphate Buffer (pH 6.8).
The values for f2 are in the acceptable range.
Analytical method Firm has submitted method verification studies
validation/verification of product including range, accuracy, precision, specificity and
robustness.
Manufacturer of API M/s Anugraha Chemicals, No D-47 to D-50, C-62 and C-63, KSSIDC, Industrial
Estate, Doddaballapur, Bangaluru Rural District-561203 India
Description of Pack ALU-ALU Blister pack packed in unit carton
(Container closure
system)
Batch No. MA089C MA090C MA091C
Batch Size 5000 Tablets 5000 Tablets 5000 Tablets
No. of Batches 03
applications with stability study data of authenticity of stability data of Rofl 500mcg tablet on
the firm (if any) the basis of which Registration Board in its 277th
meeting dated 27-29 December, 2017 decided to
approve registration of Rofl 500mcg tablet.
The HPLC software is 21 CFR compliant.
stability chambers
2. Approval of API/ DML/GMP certificate The firm have submitted copy of GMP certificate
of API manufacturer issued by #DCD/SPL.CL-1/CR-1510/2020-21 dated 06-02-
concerned regulatory authority of 2021 of M/s Anugraha Chemicals, No D-47 to D-50,
country of origin. C-62 and C-63, KSSIDC, Industrial Estate,
Doddaballapur, Bengaluru Rural District-561203 India
The firm has submitted copy of DML
#DCD/MFG/Applicant Id-240 dated 26/06/2020 of
M/s Anugraha Chemicals, No D-47 to D-50, C-62 and
C-63, KSSIDC, Industrial Estate, Doddaballapur,
Bangaluru Rural District-561203 India valid upto
13/02/2025
3. Documents for the procurement of API Firm has submitted copy of invoice # OND1200 dated
with approval from DRAP (in case of 10-11-2020 for import of 300gm of Ondansetron HCl
import). Dihydrate Batch #AOND-20014, AOND-20012 and
AOND-20013 in the name of M/s Atco Laboratories
Ltd Karachi from M/s Anugraha Chemical India.
However, the invoice is not attested by AD (I&E)
DRAP field office
4. Data of stability batches will be Firm has submitted data of stability batches supported
supported by attested respective by attested respective documents like chromatograms,
documents like chromatograms, Raw Raw data sheets, COA, summary data sheets etc.
etc.
testing
6. Record of Digital data logger for Firm has submitted record of Digital data logger for
temperature and humidity monitoring of temperature and humidity monitoring of stability
stability chambers (real time and chambers (real time and accelerated)
accelerated)
1.6.5 Valid GMP certificate issued by the The firm has submitted valid copy of
relevant regulatory authority of country GMP certificate #DCD/SPL-1/CR-
of origin of drug substance 1733/2021-22 dated 31-01-2022 of M/s
manufacturer shall be submitted Anugraha Chemicals, D-47, D-48, D-49,
D-50 and C-62, KSSIDC, Industrial
Estate, Doddaballapur, India valid upto
one year from the date of issue.
3.2.S.4 • Copies of the analytical procedures • Firm has submitted copy of BP
used for routine testing of the Drug Monograph mentioning the test used for
substance / Active Pharmaceutical routine testing of the Drug substance /
ingredient by Drug Product Active Pharmaceutical ingredient by
manufacturer is required. Drug Product manufacturer.
• Analytical Method Verification • Firm has submitted analytical Method
studies including specificity, accuracy Verification studies including
and repeatability (method precision) specificity, accuracy and repeatability
performed by the Drug Product (method precision) performed by the
manufacturer for drug substance(s) Drug Product manufacturer for drug
shall be submitted. substance.
3.2.P.2 • Submit compatibility study as the Firm has submitted drug excipient
qualitative composition of the applied compatibility study and the results show
formulation is not similar to innovator that insignificant variation occurs during
/ reference product. compatibility studies. Hence it is
Applied Zofran 8mg tab concluded that drug is compatible with
product excipients.
Lactose Lactose
anhydrous
Sodium starch Microcrystalline
glycolate Cellulose
Crospovidone Pregelatinized
maize starch
Magnesium Magnesium
stearate Stearate,
Opadry white Methyl
hydroxypropyl
cellulose
Purified water Titanium dioxide
(E171)
Iron oxide (E172)
3.2.P.5.1 Justification for finished product The firm submitted that initially at the
specifications of USP is required as the time of development, we have started the
drug substance has been analysed as per material and product development
BP specifications by M/s Atco according to British pharmacopeia
Laboratories. monograph. During the development of
(drug substance manufacturer given product, we found that the drug release of
both BP & USP specifications) both test and reference sample is greater
than 85% within 15 minutes in
comparison studies while the time limit
mentioned in BP was 45 minutes. We
switched to more stringent specification
for our products and complies with USP
specifications which states that “NLT
80% (Q) of the labeled amount of
C18H19N3O is dissolved in 15 minutes”.
3.2.P.8 Submit documents for the procurement Firm has submitted copy of commercial
of API with approval from DRAP (in invoice No. EXP-018 dated 17-08-2021
case of import). from M/s Anugraha Chemicals India in
the Name of Atco Laboratories Ltd for
import of 180gm of Ondansetron
Hydrochloride dihydrate batch No
AOND-21007 attested by AD (I&E)
The batch No. of API is different from
that submitted in batch analysis of drug
substance and stability summary sheets.
Furthermore the date of manufacturing
of API mentioned in invoice is June
2021 and attestation date of AD (I&E)
DRAP Karachi is 5/09/2021 while
manufacturing of finished product is
03/2021.
Previous Decision (321-DRB): Deferred for clarification since batch No. of API mentioned in invoice
attested by AD (I&E) DRAP is different from that mentioned in batch analysis of drug substance, BMR
and stability summary sheets of drug product
Response by the firm: The firm stated that We would like to submit some pertinent facts as follows,
which may supportive for respected Registration Board as well as you to understand the reason of above
observation.
• For product development purpose, initially ATCO has arranged Ondansetron drug substance form M/s
Anugrha Chemicals, India via our UAE based indenter Pan Golf Sourcing and Trading International
on 10-11-2020. This sample was imported by our indenter in Sharja, UAE and then supplied us
complementary through courier service. Due to direct courier of material on ATCO premises from
Sharja, material was not hold at port for clearance and we forgot to attest the invoice with DRAP ADC.
• We have used this material for product development and further put the 03 development batches for
stability studies up to 6 months on accelerated and real time conditions as per requirement of Zone IV-
B (each for tablet and syrup). Same stability data as well as material arrangement documents with ADC
non-attested invoice were initially submitted with dossier in DRAP. After pre-screening, dossiers were
accepted by DRAP and log for further evaluation.
• At the time of dossier compilation before the submission in DRAP, we have already gauged that non-
attested ADC invoice issue can be identified during dossier evaluation. Therefore, we have immediately
arranged another lot of Ondansetron drug substance from the same manufacturer i.e. M/s Anugrha
Chemicals, India with attested ADC invoice.
• We have manufactured another 03 development batches with this material and also re-conducted the
stability studies up to 6 months on accelerated and real time conditions as per Zone (IV-B) requirement.
(Both for Tablet and Syrup)
• At the time of dossier evaluation, Evaluator has advised us to submit the attested ADC invoice and we
have submitted the ADC attested invoice of second supply mentioned Ondansetron Batch#AOND-
21007. But the BMR and Stability report which was produced with first supply of Ondansetron Batch#
AOND-20013 were not replaced in dossier. This is the reason for difference in Batch No. of API
between the material invoice and product development documents.
• All tracking record for import of first material (API) dated 10-11-2020 which was imported by our
UAE based indenter Pan Golf Sourcing and Trading International form M/s Anugrha Chemicals, India
has been arranged from indenter and attached along with CoA and un-attested sale invoice for your
kind perusal.
The firm submitted that keeping in view the of above facts, you may consider that we have tried our level
best to meet all quality requirements for the development and stability studies of ondansetron tablet and
syrup. And executed more development work to meet the compliance requirement.
The firm also stated that we would like to share one more point with you that as per current policy of
Registration Board, API use for development can be arranged through direct import or may be arranged
as a loan / borrow by any other means having all record related to arrangement tracking as well as quality
verification.
The firm requested to consider these submissions for further approval of ondansetron tablet and syrup.
We assure you that we will be more vigilant in future to meet the compliance as per requirement.
Decision: Approved.
80. Name, address of Applicant / ATCO Laboratories Limited., B-18, S.I.T.E., Karachi
Marketing Authorization Holder -7500, Pakistan
Name, address of Manufacturing site. ATCO Laboratories Limited., B-18, S.I.T.E., Karachi
-7500, Pakistan
☐ Importer
☐ Export sale
Slip#65306391198)
The proposed proprietary name / brand Ondansetron Syrup 4mg/5ml
name
Strength / concentration of drug of Each 5ml contains:
Pharmaceutical form of applied drug Syrup
antagonists.
specifications
Proposed Pack size 5ml, 15ml, 25ml, 50ml, 60ml, 100ml, 120ml.
The status in reference regulatory Zofran Syrup 4 mg/5 ml MHRA approved
authorities
For generic drugs (me-too status) Dysit 4mg/5ml Syrup by M/s Wimits Pharmaceuticals
(Reg#096447)
GMP status of the Finished product The firm was inspected on 22-03-2022 & 05-04-2022
manufacturer by the panel for renewal of DML, regularization of
section as per layout plan and additional sections and
decision of panel is:
products registered in the name of firm being produced
at the site and overall good maintenance of plan and
the required documentation and SOPs, the panel
regularization of sections as per layout plan and
approval of additional sections
Name and address of API M/s Anugraha Chemicals, No D-47 to D-50, and C-62
manufacturer. to C-63, KSSIDC, Industrial Estate, Doddaballapur,
of drug substance.
(AOND-17002, AOND-17003, AOND-17004)
Real time stability study of two batches AOND-
17002, AOND-17003, conducted for 36 months while
real time stability study of one batch AOND-17004
comparative dissolution profile against the brand that is Onseron 4mg/5ml syrup by
M/s Indus Pharma (Pvt.) Ltd by performing quality
tests (description, Identification, pH, Assay).
Analytical method Firm has submitted method verification studies
validation/verification of product including range, accuracy, precision, specificity and
robustness.
Description of Pack Amber glass bottle packed in printed carton
(Container closure
system)
Batch No. FE074C MA077C MA088C
Batch Size 2000ml 2000ml 2000ml
No. of Batches 03
applications with stability study data of authenticity of stability data of Rofl 500mcg tablet on
the firm (if any) the basis of which Registration Board in its 277th
meeting dated 27-29 December, 2017 decided to
approve registration of Rofl 500mcg tablet.
stability chambers
2. Approval of API/ DML/GMP certificate The firm have submitted copy of GMP certificate
of API manufacturer issued by #DCD/SPL.CL-1/CR-1510/2020-21 dated 06-02-
concerned regulatory authority of 2021 of M/s Anugraha Chemicals, No D-47 to D-50,
country of origin. C-62 and C-63, KSSIDC, Industrial Estate,
Doddaballapur, Bengaluru Rural District-561203 India
#DCD/MFG/Applicant Id-240 dated 26/06/2020 of
M/s Anugraha Chemicals, No D-47 to D-50, C-62 and
C-63, KSSIDC, Industrial Estate, Doddaballapur,
Bangaluru Rural District-561203 India valid upto
13/02/2025
3. Documents for the procurement of API Firm has submitted copy of invoice # OND1200 dated
with approval from DRAP (in case of 10-11-2020 for import of 300gm of Ondansetron HCl
AOND-20013 in the name of M/s Atco Laboratories
Ltd Karachi from M/s Anugraha Chemical India.
DRAP field office
documents like chromatograms, Raw Raw data sheets, COA, summary data sheets etc.
etc.
testing
accelerated)
1.6.5 Valid GMP certificate issued by the The firm has submitted valid copy of
relevant regulatory authority of country GMP certificate #DCD/SPL-1/CR-
of origin of drug substance 1733/2021-22 dated 31-01-2022 of M/s
manufacturer shall be submitted Anugraha Chemicals, D-47, D-48, D-49,
D-50 and C-62, KSSIDC, Industrial
Estate, Doddaballapur, India valid upto
one year from the date of issue.
3.2.S.4 • Copies of the analytical procedures • Firm has submitted copy of BP
used for routine testing of the Drug Monograph mentioning the test used for
substance / Active Pharmaceutical routine testing of the Drug substance /
ingredient by Drug Product Active Pharmaceutical ingredient by
manufacturer is required. Drug Product manufacturer.
• Analytical Method Verification • Firm has submitted analytical Method
studies including specificity, accuracy Verification studies including
and repeatability (method precision) specificity, accuracy and repeatability
performed by the Drug Product (method precision) performed by the
manufacturer for drug substance(s) Drug Product manufacturer for drug
shall be submitted. substance.
3.2.P.2 • Submit compatibility study as the • Firm has submitted drug excipient
qualitative composition of the applied compatibility study and the results show
formulation is not similar to innovator that insignificant variation occurs
/ reference product. during compatibility studies. Hence it is
Applied Zofran 4mg/5ml concluded that drug is compatible with
product syrup excipients.
Citric acid Citric acid • Firm submitted that Pharmaceutical
monohydrate equivalence studies of test formulation
Sodium citrate Sodium citrate against locally available approved
dihydrate dihydrate formulation has been performed due to
Sodium Sodium benzoate unavailability of innovator product in
benzoate Pakistan with reference to “Decision of
Liquid Sorbitol Sorbitol solution 307th and 308th meeting of Drug
Sodium ------ Registration Board”
Saccharin
Liquid --------
Glucose
Banana Strawberry flavour
Flavour (contains ethanol*)
Purified water Purified water
• Justification is required since

pharmaceutical equivalence have not
been conducted against the innovator
product.
3.2.P.5.1 Justification for finished product The firm submitted that initially at the
specifications of USP is required as the
time of development, we have started the
drug substance has been analysed as permaterial and product development for
BP specifications by M/s Atco tablet dosage form according to British
Laboratories. pharmacopeia monograph. Once the
(drug substance manufacturer given material has been established as per BP
both BP & USP specifications) Specification, parallel development of
syrup dosage form started. The syrup
formulation is only available in United
States Pharmacopeia so we have to
develop the specifications of
Ondansetron Syrup 4mg/5mL as per USP
monograph.
3.2.P.8 Submit documents for the procurement Firm has submitted copy of commercial
of API with approval from DRAP (in invoice No. EXP-018 dated 17-08-2021
case of import). from M/s Anugraha Chemicals India in
the Name of Atco Laboratories Ltd for
import of 180gm of Ondansetron
Hydrochloride dihydrate batch No
AOND-21007 attested by AD (I&E)
The batch No. of API is different from
that submitted in batch analysis of drug
substance and stability summary sheets.
Furthermore the date of manufacturing
of API mentioned in invoice is June
2021 and attestation date of AD (I&E)
DRAP Karachi is 5/09/2021 while
manufacturing of finished product is
03/2021.
Previous Decision (321-DRB): Deferred for clarification since batch No. of API mentioned in invoice
attested by AD (I&E) DRAP is different from that mentioned in batch analysis of drug substance, BMR
and stability summary sheets of drug product
Response by the firm: The firm stated that We would like to submit some pertinent facts as follows,
which may supportive for respected Registration Board as well as you to understand the reason of above
observation.
• For product development purpose, initially ATCO has arranged Ondansetron drug substance form M/s
Anugrha Chemicals, India via our UAE based indenter Pan Golf Sourcing and Trading International
on 10-11-2020. This sample was imported by our indenter in Sharja, UAE and then supplied us
complementary through courier service. Due to direct courier of material on ATCO premises from
Sharja, material was not hold at port for clearance and we forgot to attest the invoice with DRAP ADC.
• We have used this material for product development and further put the 03 development batches for
stability studies up to 6 months on accelerated and real time conditions as per requirement of Zone IV-
B (each for tablet and syrup). Same stability data as well as material arrangement documents with ADC
non-attested invoice were initially submitted with dossier in DRAP. After pre-screening, dossiers were
accepted by DRAP and log for further evaluation.
• At the time of dossier compilation before the submission in DRAP, we have already gauged that non-
attested ADC invoice issue can be identified during dossier evaluation. Therefore, we have immediately
arranged another lot of Ondansetron drug substance from the same manufacturer i.e. M/s Anugrha
Chemicals, India with attested ADC invoice.
• We have manufactured another 03 development batches with this material and also re-conducted the
stability studies up to 6 months on accelerated and real time conditions as per Zone (IV-B) requirement.
(Both for Tablet and Syrup)
• At the time of dossier evaluation, Evaluator has advised us to submit the attested ADC invoice and we
have submitted the ADC attested invoice of second supply mentioned Ondansetron Batch#AOND-
21007. But the BMR and Stability report which was produced with first supply of Ondansetron Batch#
AOND-20013 were not replaced in dossier. This is the reason for difference in Batch No. of API
between the material invoice and product development documents.
• All tracking record for import of first material (API) dated 10-11-2020 which was imported by our
UAE based indenter Pan Golf Sourcing and Trading International form M/s Anugrha Chemicals, India
has been arranged from indenter and attached along with CoA and un-attested sale invoice for your
kind perusal.
The firm submitted that keeping in view the of above facts, you may consider that we have tried our level
best to meet all quality requirements for the development and stability studies of ondansetron tablet and
syrup. And executed more development work to meet the compliance requirement.
The firm also stated that we would like to share one more point with you that as per current policy of
Registration Board, API use for development can be arranged through direct import or may be arranged
as a loan / borrow by any other means having all record related to arrangement tracking as well as quality
verification.
The firm requested to consider these submissions for further approval of ondansetron tablet and syrup.
We assure you that we will be more vigilant in future to meet the compliance as per requirement.
Decision: Approved.
Case No. 05: Deferred cases of Human Drugs on form 5F import

81. Name, address of Applicant / Importer M/s AMB HK ENTERPRISES (PVT) LTD., 2nd
Floor, Plaza 60, Commercial, Block-K, Phase 1
DHA Lahore
Address: 2nd Floor, Plaza 60, Commercial
Block-K, Phase 1 DHA Lahore
Address of Godown: NA
Validity: 24-02-2023.
Status: License to sell drugs as distributor
Renewal: NA
Name and address of marketing authorization Hainan Brilliant Pharmaceutical Co., Ltd., 4
holder (abroad) Medicine Valley, No. 1 Road, Haikou National
High-tech Development Zone, Haikou City,
China.
Name, address of manufacturer(s) Hainan Brilliant Pharmaceutical Co., Ltd., No. 4
Fist Road of Yaogu, Haikou National High-tech
Industrial Development Zone, Haikou City,
Hainan Province, China.
Detail of certificates attached (CoPP, Freesale CoPP: Firm has submitted original legalized
certificate, GMP certificate) CoPP certificate (No. 20210060) dated 16-04-
2021 issued by Hainan Provincial Medical
Products Administration China for azithromycin
for injection 0.5g. The CoPP confirms that the
product strength is not in market of exporting
country as well as GMP status of the
manufacturing site through periodic inspection
every year.
The name of importing country on CoPP is
mentioned as Pakistan. Furthermore, the CoPP
was valid till 15-04-2023.
Details of letter of authorization / sole agency Firm has submitted notarized copy of agency
agreement agreement from M/s Hainan Brilliant
Pharmaceutical Co., Ltd. The letter species that
the manufacturer appoints M/s AMB HK
ENTERPRISES Pvt Ltd, Lahore to register
their products in Pakistan. The authorization
letter is valid till 22-10-2024. The letter issued
for azithromycin for injection 500mg.
☒ Importer
giver)
☐ Export sale
purpose only
Dy. No. and date of submission Dy. No. 26416: 23-09-2021
Details of fee submitted PKR 150,000/-: 29-06-2021
(Slip#306286776760)
The proposed proprietary name / brand name ZITHROBAR INJECTION 500mg
Strength / concentration of drug of Active Active ingredient Name; Azithromycin
Pharmaceutical ingredient (API) per unit Strength; 500mg
Pharmaceutical form of applied drug Powder for injection (Lyophillized)
Pharmacotherapeutic Group of (API) Antibacterials for systemic use, Macrolides
Proposed unit price Rs 215/-
The status in reference regulatory authorities ZITHROMAX 500mg for injection USFDA
Approved.
For generic drugs (me-too status) Azineu 500mg Injection by M/s Neutro Pharma
(Reg# 097656)
stability studies of drug substance and drug
product.
Name, address of drug substance manufacturer Zhejiang Goubang Pharmaceutical Co., Ltd.,
No.6, Weiwu Road, Hangzhou Gulf Shangyu
Economic & Technological Development Zone,
Zhejiang China
Module-III Drug Substance: Firm has submitted detailed drug substance data
(Conditions & duration of Stability studies) batches of API at accelerated as well as real time
conditions. The real time stability data is
conducted at 30 ºC ± 2ºC / 75 ± 5% RH for 24
months while accelerated stability study is
conducted at 40 ºC ± 2ºC / 75 ± 5% RH for 06
months.
Batch No# (103-180306-11, 103-180307-11,
103-180308-11)
specifications, analytical procedures, validation
of analytical procedures, batch analysis,
justification of specifications, reference
and stability.
Pharmaceutical Equivalence and Comparative Firm has submitted results of pharmaceutical
Dissolution Profile equivalence against the innovator product
Zithromax 500mg Inj by performing quality test
(pH, Water Content, Bacterial Endotoxin,
Sterility, Visible particle, Assay).
Analytical method validation/verification of Firm has submitted analytical method validation
product studies for the applied product.
Container closure system of the drug product Injection Vial made of Middle Borosilicate
Glass tubing (10ml) with brominated rubber
stopper and caps made of aluminium-
polypropylene combinations
Stability study data of drug product, shelf life and Firm has submitted stability study data of 3
storage conditions batches. The accelerated stability study data is
conducted at 40oC ±2oC / 75% ± 5% RH for 6
months. The real time stability study data is
conducted at 30oC ±2oC / 65% ± 5% RH. The
real time stability study data is submitted for 18
months only.
Batch No. Mfg. date Batch size
1905051 05.05.2019 5000 vials
1905091 09.05.2019 5000 vials
1905131 13.05.2019 5000 vials
1.3.3 The submitted CoPP confirms that the The firm submitted clarification from
product strength is not in market of Director Quality Department, Hainan
exporting country, clarify? Brilliant Pharmaceutical Co., Ltd and stated
that the azithromycin for injection 0.5g has
been marketed in China (Exporting
Country). The person responsible for the
application of CoPP misunderstood he
exporting country was referring to Pakistan
thus ticked wrong column in CoPP.
1.5.2 Strength of Active ingredient shall be The firm have submitted the label claim as:
stated clearly. In case API is in the form Each vial contains:
of salt / hydrate, specify the equivalent Azithromycin as dihydrate…….500mg
strength of the base e.g., AAA sodium
50 mg (equivalent to AAA) etc.
1.5.15- Commitments must be submitted by The firm has submitted commitments as per
1.5.20 applicant (marketing authorization guidance document
Holder) instead of manufacturer
1.6.5 Valid GMP certificate / DML of the The firm has submitted GMP certificate
Drug Substance manufacturer issued by No. ZJ20190170 in the name of M/s
relevant regulatory authority of country Zhejiang Goubang Pharmaceutical Co.,
of origin is required Ltd., No.6, Weiwu Road, Hangzhou Gulf
Shangyu Economic & Technological
Development Zone, Zhejiang China valid
upto 29/11/2024
3.2.S.4 • Copies of the analytical procedures • Copies of the analytical procedures used
used for routine testing of the Drug for routine testing of the Drug substance
substance /Active Pharmaceutical /Active Pharmaceutical Ingredient by
Ingredient by Drug substance Drug substance manufacturer and drug
manufacturer and drug product product manufacturer is submitted.
manufacturer is required • Analytical Method Verification studies
• Analytical Method Verification including specificity, linearity range,
studies including specificity, accuracy precision, accuracy, solution stability and
and repeatability (method precision) robustness performed by the Drug
performed by the Drug Product Product manufacturer for drug
manufacturer for drug substance(s) substance(s) is submitted.
shall be submitted.
3.2.P.5 • You have applied for USP The firm submitted that specification
specifications. However, the limits for applied for azithromycin for injection 0.5g
assay test given in specifications is not is in-house specification rather than USP,
according to USP monograph, clarify? so there is difference in specification, test
Release specifications; (103%-113%) items and chromatographic conditions
Shelf life specifications; (101%-115%) compared to USP.
Monograph: (90%-110%)
• Test for uniformity of dosage units is
not included in specifications
recommended by USP
• The chromatographic conditions of
the analytical method are different
from the USP monograph (mobile
phase, injection volume, lambda,
3.2.P.8 • Submit stability study data of drug The firm have submitted stability study data
product till the claimed shelf life of three batches. The accelerated stability
study data is conducted at 40oC ±2oC / 75%
± 5% RH for 6 months. The real time
stability study data is conducted at 30oC
±2oC / 65% ± 5% RH for 24 months
Previous Decision (321-DRB): Deferred for following points:
• clarification for not complying USP specifications of finished drug product as USP specifications are more
stringent to in-house specifications.
• Whether manufacturing has been done via lyophilization or dry powder filling and relevant manufacturing
facility thereof.
Evaluation by PEC:
• The firm has submitted USP specifications for the applied product. The firm has also submitted
commitment to provide product according to USP specifications.
• The firm submitted that manufacturing has been done by method of lyophilisation and submitted
inspection report for relevant section of manufacturer. The firm has also submitted cGMP certificate
No#HI20190027 in name of M/s Hainan Brilliant Pharmaceutical Co., Ltd., 4 Medicine Valley, No. 1
Road, Haikou National High-tech Development Zone, Haikou City, China for lyophilized powder for
injection valid upto 28-05-2024
Decision: Deferred for following:
• Clarification since the Chinese Pharmacopeia doesnot include the test for quantification of impurity
E as recommended by USP monograph
• Clarification since the limits of assay test given in Chinese Pharmcoapeia i.e. 101-115% is different
than that recommended by USP i.e. 90-110%.
82. Name, address of Applicant / Importer M/s AMB HK ENTERPRISES (PVT) LTD., 2nd
Floor, Plaza 60, Commercial, Block-K, Phase 1
DHA Lahore
Address: 2nd Floor, Plaza 60, Commercial Block-K,
Phase 1 DHA Lahore
Validity: 24-02-2023.
Renewal: NA
Name and address of marketing JARI Pharmaceutical Co., Ltd., 18 Zhenhua Road,
authorization holder (abroad) Lianyungang City, Jiangsu P.R China, 222006
Name, address of manufacturer(s) JARI Pharmaceutical Co., Ltd., 18 Zhenhua Road,
Lianyungang City, Jiangsu P.R China, 222006
Detail of certificates attached (CoPP, CoPP: Firm has submitted original, legalized CoPP
Freesale certificate, GMP certificate) certificate (No. JS20210117) dated 04-02-2021
issued by Jiangsu drug Administration China for
oxaliplatin for injection 50mg. The CoPP confirms
free sale status of the product in exporting country as
well as GMP status of the manufacturing site through
periodic inspection every year.
mentioned as Pakistan. Furthermore, the CoPP is
valid till 03-02-2023.
Details of letter of authorization / sole Firm has submitted notarized copy of foreign agency
agency agreement agreement dated February 02, 2021 in which M/s
JARI Pharmaceutical Co., Ltd., referred to as the
manufacturer grants M/s Liaoning Hongyan
Pharmaceutical Co., Ltd exclusive right to export and
sell all product (Ten (10) in number) including
oxaliplatin for injection 50mg in Pakistan.
M/s Liaoning Hongyan Pharmaceutical Co., Ltd
referred to as exporter grants M/s AMB HK
ENTERPRISES Pvt Ltd, Pakistan exclusive rights
to sell and distribute the products from M/s Liaoning
Hongyan Pharmaceutical Co., Ltd in Pakistan which
has an understanding with M/s JARI Pharmaceutical
Co., Ltd.,
The agreement shall be effective from date of
execution and shall remain in force for five (05)
years.
☒ Importer
☐ Export sale
purpose only
Details of fee submitted PKR 150,000/-: 26-05-2021 (Slip#076513194992)
The proposed proprietary name / brand Runplatin Injection 50mg
name
Strength / concentration of drug of Active Active ingredient Name: Oxaliplatin
Pharmaceutical ingredient (API) per unit Strength; 50mg
Pharmaceutical form of applied drug Lyophilized powder for Injection
Pharmacotherapeutic Group of (API) Not applicable
Reference to Finished product specifications Chinese Pharmacopeia
Proposed Pack size 20 ml
Proposed unit price PKR 7700/-
The status in reference regulatory authorities GN-OXALIPLATIN oxaliplatin 50 mg powder for
injection vial TGA Approved.
For generic drugs (me-too status) Oxaliplatino Varifarma Lyophilized Powder for
Injection 50mg by M/s Medinet Pharmaceuticals
(Reg# '095884)
its validation, batch analysis and justification of
drug product.
Name, address of drug substance Kunming Guiyan Pharmaceutical Co., Ltd., Room
manufacturer 706, Integrated Business Building in Jinding Science
& technology zone, 690#, Xuefu Road, Kuming,
Yunnan, China, 650033
and controls, impurities, specifications, batch
Stability Studies of Drug Substance Firm has submitted stability study data of 3 batches
(Conditions & duration of Stability studies) of API at accelerated as well as real time conditions.
The real time stability data is conducted at 25 ºC ±
2ºC / 60 ± 5% RH for 36 months of following
batches.
Batch No# (L20150613, L20161010, L20161106)
Accelerated stability study is conducted at 40 ºC ±
2ºC / 75 ± 5% RH for 06 months of following
batches.
Batch No# (L20090107, L20090108, L20090109)
specifications, analytical procedures, batch analysis,
materials, container closure system and stability
study of drug product.
Pharmaceutical Equivalence and Not submitted
Analytical method validation/verification of Not submitted
product
Container closure system of the drug product Medium boron silicon glass tube-type vial (20ml),
pharmaceutical bromobutyl rubber stopper and caps
made of aluminium plastic combination
Stability study data of drug product, shelf life Firm has submitted stability study data of 3 batches.
and storage conditions The accelerated stability study data is conducted at
40oC ±2oC / 75% ± 5% RH for 6 months. The real
time stability study data is conducted at 30oC ±2oC /
75% ± 5% RH. The real time stability study data is
submitted for 36 months only.
Batch No. Mfg. date Date of
initiation
17101817 02-2017 03-2017
17102517 02-2017 03-2017
18051217 02-2017 03-2017
1.4.1 Applicant needs to clarify whether the The firm have submitted that applied product
applied product (drug product) is is intended both for domestic and export sale
intended for sale in domestic market or
both for domestic and export market.
There is no column for overseas sale
1.5.2 Strength of Active ingredient shall be Each vial contains:
stated clearly. In case API is in the Oxaliplatin …….50mg
form of salt / hydrate, specify the
equivalent strength of the base e.g.,
AAA sodium 50 mg (equivalent to
AAA) etc.
1.5.5 Indicate Pharmacological class of the Firm have indicated Pharmacological class
API (drug substance) with proper of the API (drug substance).
reference. Also, state the WHO ATC Third generation platinum anticancer drug
code for each distinct therapeutic ATC Code; L01XA03
indication.
1.5.15- Commitments must be submitted by Firm have submitted commitment as per
1.5.20 applicant (marketing authorization guidance document
Holder) instead of manufacturer
1.6.5 • The drug substance manufacturer as • The firm submitted that drug substance
per section 3.2.S.2 is Kunming manufacturer is Kunming Guiyan
Guiyan Pharmaceutical Co., Ltd., Pharmaceutical Co., Ltd., Room 706,
Room 706, Integrated Business Integrated Business Building in Jinding
Building in Jinding Science & Science & technology zone, 690#, Xuefu
technology zone, 690#, Xuefu Road, Road, Kuming, Yunnan, China, 650033
Kuming, Yunnan, China, 650033 and it was a mistake at their end by writing
while you have written JARI wrong name of manufacturer
Pharmaceutical Co., Ltd., 18 • The firm has submitted copy of GMP
Zhenhua Road, Lianyungang City, certificate No. YN20170040 in the name of
Jiangsu P.R China, 222006 China in M/s Kunming Guiyan Pharmaceutical Co.,
this section, clarify? Ltd., Inside Kunming Precious Metals
• Submit GMP certificate of drug Research Institute, No. 988, Keji Road,
substance manufacturer High-tech Development Zone, Kunming
City China valid upto 24/12/202
3.2.S.4 • Test for content of platinum is not • We refer to EP, content of platinum is not
included in specifications although included in EP specifications
recommended by USP • Firm have submitted copies of the Drug
• Copies of the Drug substance substance specifications and analytical
specifications and analytical procedures used for routine testing of the
procedures used for routine testing of Drug substance /Active Pharmaceutical
the Drug substance /Active Ingredient Drug Product manufacturer.
Pharmaceutical Ingredient by both Copies of Drug substance specifications
drug substance manufacturer and and analytical procedures used for
Drug Product manufacturer is routine testing of the Drug substance
required. /Active Pharmaceutical Ingredient by
• Analytical Method Verification Drug substance manufacturer is not
studies including specificity, submitted
accuracy and repeatability (method • Analytical Method Verification studies is
precision) performed by the Drug not submitted as per requirement
Product manufacturer for drug • The firm submitted batch analysis of drug
substance(s) shall be submitted. substance as per EP.
• Test results of Batch analysis are
submitted as per USP specifications.
However, the specifications of
applied product are given according
to EP, clarify?
3.2.S.8 Justify why stability study data of Firm have submitted long term stability
different batches of drug substance study data at 25 ºC ± 2ºC / 60 ± 5% RH for
conducted at accelerated and real time
36 months of same batches for which
conditions is submitted. stability study data at accelerated conditions
is submitted.
Batch No# (L20090107, L20090108,
L20090109)
3.2.P.2 • Reference product has used lactose • The firm submitted that through
monohydrate while you have use conversion lactose content is consistent
lactose in composition of applied with reference product
product, clarify?
• Submit Pharmaceutical equivalence • The firm submitted pharmaceutical
of the applied product against the equivalence of applied product with
innovator product product of Jiangsu Hengrui
Pharmaceutical Co., Ltd
3.2.P.5 • Analytical Method Verification Firm have submitted Analytical Method
studies including specificity, Verification studies including specificity,
accuracy and repeatability (method and repeatability (method precision).
precision) performed by the Drug However, results of accuracy test is still not
Product manufacturer for drug submitted
product shall be submitted.
The firm has applied for Chinese pharmacopeia specifications while the monograph for the applied
product is available in USP and the limits of tests of applied product are in line with USP
specifications.
Previous Decision (321-DRB): Deferred for following:
• Submission of Pharmaceutical equivalence studies against the innovator product.
• Submission of Copies of Drug substance specifications and analytical procedures used for routine testing
of the Drug substance /Active Pharmaceutical Ingredient by Drug substance manufacturer.
• Submission of Analytical Method Verification studies for drug substance
• Submission of results of accuracy test in method verification studies for drug product
Evaluation by PEC:
• The firm has submitted pharmaceutical equivalence of applied product against innovator product Eloxatin
Injection Batch No. 1802956 manufactured by M/s Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807, A
SANOFI COMPANY 2020 sanofi-aventis U.S. LLC.
• Firm has submitted Copies of Drug substance specifications and analytical procedures used for routine
testing of the Drug substance by Drug substance manufacturer.
• Firm has submitted Analytical Method Verification studies for drug substance
• Firm has submitted results of accuracy test in method verification studies for drug product
Decision: Approved with USP specifications and with following label claim.
Each vial contains:
Oxaliplatin …….50mg
• Approval is as per Policy for inspection of Manufacturer abroad and verification of local
storage facility.
Deferred Cases of Paracetamol containing formulations

DRAP Authority in its 147th meeting decided as under:
“In order to ensure the smooth and continuous supply of paracetamol tablets across Pakistan under
prevailing circumstances, the Authority, as one-time exercise, approved incentivization to the
manufacturers in the form of out-of-queue consideration of applications of registration of:
iii) 01 generic (me-too) molecule on manufacturing and immediate distribution of at least
15,000 packs of paracetamol tablets with pack size of 200 tablets.
iv) All dosage forms of paracetamol & its combination products with the condition of immediate
manufacturing and distribution.
83. Name, address of Applicant / Marketing M/s Bosch Pharmaceuticals (Pvt.) Ltd., Plot No. 209,
Authorization Holder Sector 23, Korangi Industrial Area, Karachi
Name, address of Manufacturing site. M/s Bosch Pharmaceuticals (Pvt.) Ltd., Plot No. 209,
Sector 23, Korangi Industrial Area, Karachi
☐ Importer
☐ Export sale
PKR 25000/- dated 14/03/2022 (Slip#446590164659)
The proposed proprietary name / brand Bofalgan Plus 1gm / 300mg infusion
name
Strength / concentration of drug of Active Each 100ml vial contains:
Pharmaceutical ingredient (API) per unit Paracetamol…………..……..1000mg.
Ibuprofen (as sodium dihydrate)………….300mg
Pharmaceutical form of applied drug Infusion
Pharmacotherapeutic Group of (API) Other Analgesics and Antipyretics
Reference to Finished product Innovator’s Specifications.
specifications
Proposed unit price As per S.R.O
The status in reference regulatory MAXIGESIC IV paracetamol 1000mg and ibuprofen
authorities (as sodium dihydrate) 300mg in 100mL solution for
infusion vial TGA Approved
Combogesic IV 10mg/ml + 3mg/ml [1000mg /
300mg in 100ml] solution for infusion MHRA
Approved
Combogesic 10 mg/ml Paracetamol + 3 mg/ml
Ibuprofen solution for infusion Ireland Approved
Name and address of API manufacturer. Paracetamol:
Mallinckrodt Inc. Raleigh Pharmaceutical Plant 8801
Capital Boulevard Raleigh, North Carolina 27616
Ibuprofen:
Manufacturing Facility I:
Solara Active Pharma Sciences Limited., Mathur
Road, periyakalapet Puducherry 605014, India
Manufacturing Facility II:
Solara Active Pharma Sciences Limited., AI/B,
SIPCOT Industrial Complex, Kudikadu Village,
Cuddalore 607005 Tamil Nadu India
product.
Module III (Drug Substance) Firm has submitted detailed data for drug substance
impurities, batch analysis and justification of
Stability studies Paracetamol:
Firm has submitted stability study data of 3 batches of
at 40°C ± 2°C / 75% ± 5% RH for 6 months of
following batches:
Batches; 6088907C189, 0057907C398, 4814907C222
The real time stability data is conducted at 30°C ± 2°C
/ 65 ± 5% RH for following batches;
005712B026 for 02 years, 7637511C029 for 03years,
554210C126 for 04 years.
Ibuprofen:
5% RH for 18months at manufacturing facility I;
Batches; 3ISH180001, 3ISH180002, 3ISH180003
5% RH for 09months at manufacturing facility II;
Batches; CIBD19001V, CIBD19002V, CIBD19003V,
Module-III (Drug Product): Firm has submitted data of drug product including its
development, manufacture, manufacturing process and
process control, process validation protocols, control of
comparative dissolution profile against the brand that is Maxigesic IV Solution for
Infusion by M/s AFT Pharmaceuticals New Zealand
by performing quality tests (description, filled volume,
particulate matter, Assay).
Analytical method validation/verification Firm have submitted analytical method validation
of product studies including accuracy, precision, specificity,
linearity and robustness.
Mallinckrodt Inc. Raleigh Pharmaceutical Plant 8801 Capital Boulevard
Raleigh, North Carolina 27616
Ibuprofen:
Manufacturing Facility I:
Solara Active Pharma Sciences Limited., Mathur Road, periyakalapet
Puducherry 605014, India
Manufacturing Facility II:
Solara Active Pharma Sciences Limited., AI/B, SIPCOT Industrial
Complex, Kudikadu Village, Cuddalore 607005 Tamil Nadu India
API Lot No. Paracetamol; 784520M020
Ibuprofen Sodium dihydrate; CISH210013
Description of Pack Clear Transparent glass vial (100ml) with rubber stopper and dark blue
(Container closure system) aluminum seal with Bosch logo
Batch No. TR-BFP-02 TR-BFP-03 TR-BFP-04
Batch Size 250 Vials 250 Vials 250 Vials
No. of Batches 03
1. Reference of previous approval of No details of previous inspection submitted the firm
firm (if any)
2. Approval of API/ DML/GMP certificate of The firm have submitted copy of CoPP certificate #01-
API manufacturer issued by concerned 0028-2016-02-ES dated 28/01/2016 of M/s
regulatory authority of country of origin. Mallinckrodt Inc. Raleigh Pharmaceutical Plant 8801
Capital Boulevard Raleigh, North Carolina 27616 for
Acetaminophen USP / Paracetamol Fine Powder issued
by USFDA indicating the GMP compliant status of the
manufacturer.
The firm have submitted copy of GMP certificate

#WC-0126 dated 26/07/2019 of M/s Solara Active
Pharma Sciences Limited., R.S.No. 33& 34, Mathur
Road, periyakalapet, Puducherry-605014, India (for
Ibuprofen Sodium Dihydrate) issued by Central Drugs
Standard Control Organization Ministry of Health and
Family welfare India valid upto three years from date
of issue.
This certificate is being issued subject to condition
that the firm shall obtain NOC from competent
authority, case to case basis, to manufacturer the
above mentioned active substance for purpose of
export only, as above mentioned active substance are
not approved for manufacturer for sale in India
3. Documents for the procurement of API with Firm has submitted copy of commercial invoice No.
approval from DRAP (in case of import). 19075278 dated 17/02/2021 in the name of M/s Bosch
Pharmaceuticals (Pvt.) Ltd., for import of 1500Kg
Paracetamol Fine powder (Batch No 784520M020)
from M/s Mallinckrodt Chemical Limited attested by
AD (I&E) DRAP Karachi on 22/02/2021.
Firm has submitted copy of commercial invoice No.
1107300837 dated 16/04/2021 in the name of M/s
Bosch Pharmaceuticals (Pvt.) Ltd., for import of 05Kg
Ibuprofen Sodium (Batch No CISH210013) from M/s
Solara Active Pharma Sciences Limited manufacturing
site II attested by AD (I&E) DRAP Karachi on
29/04/2021.
chromatograms, Raw data sheets, COA, sheets, COA, summary data sheets is submitted
testing
6. Record of Digital data logger for Not submitted
accelerated)
1.1 • Submit original fee deposit slip of PKR
25000/-
1.3.5 • Submit GMP inspection report/ GMP
certificate of the manufacturing unit issued
within the last three years
1.6.5 • Mention Name and address of API
manufacturer (Both paracetamol and
Ibuprofen) in this section
• Submit Valid GMP certificate / DML of the
Drug Substance manufacturer (for
ibuprofen) issued by relevant regulatory
• GMP certificate of manufacturing site I is
submitted while API is imported from
manufacturing site II
3.2.S.4 • Copies of specifications and analytical
procedure used for routine testing of drug
substance paracetamol by drug product
manufacturer is required
• Analytical method verification studies for
paracetamol drug substance by drug product
• Submit Certificate of Analysis (CoA) of the
relevant batch used during product
development and stability studies from Drug
Substance manufacturer.
• Copies of specifications and analytical
procedure used for routine testing of drug
substance Ibuprofen by drug product
• Analytical method validation studies for
ibuprofen drug substance by drug product
• Some analytical procedure for ibuprofen
drug substance given by drug substace
manufacturer is from M/s Shasun chemicals
and drugs, clarify?
• Submit Certificate of Analysis (CoA) of the
relevant batch used during product
development and stability studies from Drug
Substance manufacturer.
3.2.S.6 • Reference standard of Ibuprofen drug
substance if provided from M/s Shasun
chemicals and drugs while Solara Active
Pharma Sciences Limited is manufacturer of
Ibuprofen, clarify?
3.2.S.7 • Stability data of paracetamol of different
conditions is submitted clarify?
3.2.P.1 • Justification is required for not preforming
pH test and sterility test in pharmaceutical
equivalence as per submitted specification of
drug product
3.2.P.6 • Reference standard of Ibuprofen drug
substance if provided from M/s Shasun
chemicals and drugs while Solara Active
Pharma Sciences Limited is manufacturer of
Ibuprofen, clarify?
3.2.P.8 • Submit 6th month stability study data at both
real time and accelerated conditions
• Initial page of stability summary sheet
containing batch No. of FPP, API, storage
conditions, date of manufacturing, date of
initiation of stability study is not submitted
• Stability data of different batches at real time
conditions (TR-BFP-02, TR-BFP-03, TR-
BFP-04) and Accelerated conditions (TR-
BOINJ-02, TR-BOINJ-04, TR-BOINJ-03) is
submitted clarify
• Submit Record of Digital data logger for
accelerated)
Decision of 321st meeting of Registration Board:
The Board deferred the case for clarification of the above mentioned points.
Evaluation by PEC:
1.1 • Submit original fee deposit slip of PKR The firm has submitted original fee
25000/- challan # 446590164659 of Rs.
25000/- for applied product
1.3.5 • Submit GMP inspection report/ GMP The firm has submitted cGMP
certificate of the manufacturing unit issued certificate issued on 13th June, 2022
within the last three years based on inspection conducted on 13-
06-2022
1.6.5 • Mention Name and address of API • The firm has mentioned Mention
manufacturer (Both paracetamol and Name and address of API
Ibuprofen) in this section manufacturer (Both paracetamol
• Submit Valid GMP certificate / DML of the and Ibuprofen) in this section
Drug Substance manufacturer (for • The firm have submitted copy of
ibuprofen) issued by relevant regulatory GMP certificate No: K. Dis. No:
authority of country of origin. 12632/D1/4/2020 dated 17-02-2021
• GMP certificate of manufacturing site I is of manufacturing sit II of M/s Solara
submitted while API is imported from Active Pharma Sciences Limited.,
manufacturing site II AI/B, SIPCOT Industrial Complex,
Kudikadu Village, Cuddalore
607005 India issued by Directir of
Drugs Control Tamil Nadu India
3.2.S.4 • Copies of specifications and analytical • Copies of specifications and
procedure used for routine testing of drug analytical procedure used for
substance paracetamol by drug product routine testing of drug substance
manufacturer is required paracetamol by drug product
• Analytical method verification studies for manufacturer is submitted
paracetamol drug substance by drug product • Analytical method verification
manufacturer is required studies for paracetamol drug
• Submit Certificate of Analysis (CoA) of the substance by drug product
relevant batch used during product manufacturer is submitted.
development and stability studies from Drug However, results of repeatability
Substance manufacturer. (method) precision is not submitted
• Copies of specifications and analytical • Firm has submitted Certificate of
procedure used for routine testing of drug Analysis (CoA) of the relevant batch
substance Ibuprofen by drug product of paracetamol drug substance used
manufacturer is required during product development and
• Analytical method validation studies for stability studies from Drug
ibuprofen drug substance by drug product Substance manufacturer.
manufacturer is required • Copies of specifications and
• Some analytical procedure for ibuprofen analytical procedure used for
drug substance given by drug substance routine testing of drug substance
manufacturer is from M/s Shasun chemicals Ibuprofen by drug product
and drugs, clarify? manufacturer is submitted
• Submit Certificate of Analysis (CoA) of the • Analytical method validation
relevant batch used during product studies (including linearity, range,
development and stability studies from Drug accuracy, precision, specificity, and
Substance manufacturer. robustness) for ibuprofen drug
substance by drug product
manufacturer is submitted
• The firm submitted that Shasun
Chemical / Solara Active Pharma
science is same company as Solara
Active Pharma Science are new
name of merged entity. The firm has
also submitted relevant details from
manufacturer. The firm further
stated that name change donot have
any impact on the manufacturing
process, facility, specification and
testing method employed for
product.
• Firm has submitted Certificate of
Analysis (CoA) of the relevant batch
of Ibuprofen Sodium dihydrate drug
substance used during product
development and stability studies
from Drug Substance manufacturer.
3.2.S.6 • Reference standard of Ibuprofen drug Firm has submitted Reference
substance is provided from M/s Shasun standard of Ibuprofen sodium
chemicals and drugs while Solara Active dihydrate drug substance from
Pharma Sciences Limited is manufacturer of manufacturer Solara Active Pharma
Ibuprofen, clarify? Sciences Limited
3.2.S.7 • Stability data of paracetamol of different Firm has submitted stability study
batches at real time and accelerated data of 3 batches of drug substance
conditions is submitted clarify? paracetamol at both accelerated as
well as real time conditions. The
accelerated stability data is conducted
at 40°C ± 2°C / 75% ± 5% RH for 6
months and The real time stability
data is conducted at 30°C ± 2°C / 65
± 5% RH.
Batches; 005712B026, 737511C029,
016713H864.
Real time stability study of batch
005712B026 is conducted for 2 years,
of batch 737511C029 for three years,
of batch 016713H864 for 18 months
3.2.P.1 • Justification is required for not preforming The firm submitted that
pH test and sterility test in pharmaceutical pharmaceutical equivalence is
equivalence as per submitted specification of performed as per specifications
drug product (Description, filled volume,
particulate matter, assay) and stated
that they also performed pH and
sterility simultaneously and now have
incorporated required information in
pharmaceutical equivalence protocol
and record.
3.2.P.6 • Reference standard of Ibuprofen drug Firm has submitted Reference
substance if provided from M/s Shasun standard of Ibuprofen sodium
chemicals and drugs while Solara Active dihydrate drug substance from
Pharma Sciences Limited is manufacturer of manufacturer Solara Active Pharma
Ibuprofen, clarify? Sciences Limited
3.2.P.8 • Submit 6th month stability study data at both • Firm has submitted 6th month
real time and accelerated conditions stability study data at both real time
• Initial page of stability summary sheet and accelerated conditions
containing batch No. of FPP, API, storage • Firm has submitted Initial page of
conditions, date of manufacturing, date of stability summary sheet containing
initiation of stability study is not submitted batch No. of FPP, API, storage
• Stability data of different batches at real time conditions, date of manufacturing,
conditions (TR-BFP-02, TR-BFP-03, TR- date of initiation of stability study
BFP-04) and Accelerated conditions (TR- • The firm submitted that we regret
BOINJ-02, TR-BOINJ-04, TR-BOINJ-03) is for typographical error on
submitted clarify accelerated condition stability
• Submit Record of Digital data logger for summary sheet batch No has been
temperature and humidity monitoring of corrected as real time conditions
stability chambers (real time and (TR-BFP-02, TR-BFP-03, TR-BFP-
accelerated) 04).
• Firm has submitted Record of
Digital data logger for temperature
accelerated)
Therapeutic indications
Maxigesic® IV is indicated in adults for the relief of mild to moderate pain and the reduction of fever, where
an intravenous route of administration is considered clinically necessary.
Dose and method of administration
Administer one vial (100 mL) Maxigesic® IV as a 15-minute infusion every 6 hours, as necessary. Do not
exceed a total daily dose of 4000 mg (4 g) paracetamol.
Decision: Approved.
• Registration Board directed the firm to submit results of repeatability (method precision) test for
drug substance paracetamol and submit data before issuance of registration letter.
proposed shelf life and on accelerated studies for six months as per the commitment submitted in the
registration application.
Deferred case of New Section:

M/s Invictus Pharmaceuticals Plot No. 21 & 26, Street No. NS-2, RCCI, Industrial Estate, Rawat”.
The Central Licensing Board in its 273rd meeting held on 15th January, 2020 has considered and
approved the following three (03) sections of “M/s Invictus Pharmaceuticals Plot No. 21 & 26, Street
No. NS-2, RCCI, Industrial Estate, Rawat” under Drug Manufacturing License No. 000892
(Formulation) vide approval letter No. F. 1-37/2016-Lic (Vol-I) dated 18th February 2020.
S No. Section
1. Dry Powder Injection Section (Cephalosporine)
2. Dry Powder for suspension Section
(Cephalosporine))
3. Capsule Section (Cephalosporine)
Following applications have been submitted for registration by the firm.

84. Name, address of Applicant / Invictus Pharmaceuticals., NS2, Rawalpindi, Rawat
Marketing Authorization Holder Industrial Estate, Islamabad, Rawalpindi, Islamabad Capital
Territory
Name, address of Manufacturing site. Invictus Pharmaceuticals., NS2, Rawalpindi, Rawat
Industrial Estate, Islamabad, Rawalpindi, Islamabad Capital
Territory
☐ Importer
☐Is involved in none of the above (contract giver)
The proposed proprietary name / Cef-Vic 400mg capsule
brand name
Strength / concentration of drug of Each Capsule contains:
Active Pharmaceutical ingredient Cefixime as Trihydrate…….400mg
(API) per unit
Pharmaceutical form of applied drug White to off white powder filled in Size “0” Shell and
packed in Alu-Alu pack of 5’s.
Reference to Finished product Innovator specifications
specifications
Proposed Pack size Alu/Alu of Pack size of 5’s.
The status in reference regulatory Cefixime 400mg Capsule by M/s Alkem Labs Ltd USFDA
authorities approved
For generic drugs (me-too status) Cebosh 400mg Capsule by M/s Bosch Pharmaceuticals
(Reg# 027160)
GMP status of the Finished product New section
manufacturer
Name and address of API Pharmagen Limited., Kot Nabi Bukshwala, 34 Km Ferozepur
manufacturer. Road, Lahore.
Tel: +92 (042) 5935261-68
Fax: +92 (042) 5935269
E-mail: pblbd@hotmail.com
Web: www.pharmagen.com.pk
manufacturers, Characterization, specifications, analytical
of specification, reference standard, container closure system
and stability studies of drug substance. The firm has
summarized information of drug product including its
validation/verification of analytical procedures, batch
analysis, justification of specifications, reference standard or
Module III (Drug Substance) Firm has submitted detailed data for both drug substance data
solubilities, physical form, manufacturers, description of
specifications, analytical procedures and its validation, batch
analysis and justification of specification, reference standard,
substance.
Stability studies Firm has submitted stability study data of 3 batches of drug
substance at both accelerated as well as real time conditions.
The accelerated stability data is conducted at 40 O ± 2 O C
/75% ± 5% RH for 6 months. The real time stability data is
conducted at 30OC ± 2 O C / 65% ± 5% RH for 36 months.
Module-III (Drug Product): The firm has submitted detail of manufacturers, description
specifications, analytical procedure batch analysis and
justification of specification, reference standard, container
Pharmaceutical equivalence and Firm has performed pharmaceutical equivalence and
comparative dissolution profile comparative dissolution profile against the product Cefspan
Capsule 400mg by M/s Barrett Hodgson (Pvt) Ltd
Analytical method Not submitted
Manufacturer of API Pharmagen Limited., Kot Nabi Bukshwala, 34 Km Ferozepur Road, Lahore.
manufacturer Tel: +92 (042) 5935261-68
Fax: +92 (042) 5935269
E-mail: pblbd@hotmail.com
Web: www.pharmagen.com.pk
API Lot No. 00243/078/2020
Description of Pack The granular dry powder for capsule will be filled in a Size “0” Empty Hard Gelatin
(Container closure Shell and blistered in Alu/Alu of Pack size of 5’s.
system)
Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
Batch No. Tc-001 Tc-002 Tc-003
Batch Size 2500 2500 2500
No. of Batches 03
1. Reference of previous approval of NA
the firm (if any)
2. Approval of API/ DML/GMP certificate GMP certificate of M/s Pharmagen Limited issued on
of API manufacturer issued by concerned 11.01.2019 based on inspection conducted on 08.01.2019
3. Documents for the procurement of API Not Applicable
import).
4. Data of stability batches will be Firm has submitted record of testing of all batches along
supported by attested respective with chromatograms, and summary data sheets.
etc.
5. Compliance Record of HPLC software N/A
testing
6. Record of Digital data logger for Firm has submitted record of data logger for temperature
temperature and humidity monitoring of and humidity monitoring of real time and accelerated
stability chambers (real time and stability chambers.
accelerated)
Evaluation by PEC XI:
1.3.3 Specify the status of applicant as you The firm have submitted revised form 5-F and specified
have submitted that applicant “Is the status of applicant as “manufacturer”
involved in none of the above
(contract giver)” in module 1 of form
5F
1.3.1.- The address mentioned in submitted The firm have submitted revised form 5-F and corrected
1.3.2 application is different from the the address as per DML
address mentioned on DML, clarify?
1.5.6 In Form 5F you have mentioned The firm have revised the specifications to JP
innovator’s specifications for the specifications
product under section 1.5.6. while the
monograph of applied product is
available in JP, clarify?
2.3. Submit module 2 as per WHO QOS- Firm have submitted module 2 as per WHO QOS-PD
PD template without referring to any template
annexure of Module III.
3.2.S.4. As per the drug substance The firm have submitted certificate of analysis of drug
1. specifications of the drug substance substance in which the drug substance follows USP
manufacturer i.e. M/s Pharmagen specifications
Limited, the firm submitted that
material complies BP, USP and in-
house specifications, justification is
required as how the drug substance
follow all the specifications
3.2.S.4. Copies of the Drug substance Drug substance specification and analytical procedure
1. - specifications and analytical of Invictus Pharmaceuticals is provided. However, the
3.2.S.4. procedures used for routine testing of analytical procedure does not contain procedure for
2 the Drug substance /Active identification test (IR), pH, water content and specific
Pharmaceutical Ingredient by Drug rotation as recommended by USP and contain only
Product manufacturer is required. procedure for assay test.
3.2.S.4. Analytical Method Verification No reply submitted
3 studies including specificity, accuracy
and repeatability (method precision)
performed by the Drug Product
manufacturer drug substance(s) shall
be submitted.
3.2.S.4. The Batch No. mentioned in batch The firm submitted that batch No. of the drug substance
4 analysis by drug substance cefixime used is 00243/078/2020 and submitted COA of
manufacturer is 00243/078/2020 drug substance from drug substance manufacturer and
while the Batch No. mentioned in drug product manufacturer. The firm further stated that
batch analysis by drug product compacted cefixime is used in formulation of cefixime
manufacturer 00243/264/2020, capsule as depicted in COA. However, COA of same
clarify? batch number of API was submitted for micronized
Furthermore, COA submitted by the form of cefixime previously.
drug substance manufacturer and drug
product manufacturer shows that
micronized cefixime was used in
formulation of cefixime capsule,
clarify?
3.2.P.1 • The composition of applied product • The response is submitted in subsection 3.2.P.2.1.1
is not as per innovator’s product, • Quantity of cefixime per unit dose and per batch have
clarify been explained and justified based upon the salt factor
Applied product SUPRAX calculation and assay results. The justification is
400mg submitted.
capsules • Firm has used the theoretical factor for adjustment of
Cefixime Cefixime water content while dispensing, instead of the actual
trihydrate trihydrate results of “water content test” reported in the drug
Colloidal silicon Colloidal substance analysis.
dioxide silicon • The firm submitted that we have used no overages in
dioxide our formulation
Crospovidon
e
Microcrystalline Low
cellulose 102 Substituted
Hydroxy
Propyl
Cellulose,
Magnesium Magnesium
Stearate, Stearate,
EHG Capsule shell Mannitol
‘0’ size
• Quantity of cefixime per unit dose

shall be justified with equivalency
factor for cefixime trihydrate.
• You have mentioned the use of
overages in your formulation to
compensate the potency of the
product during process loss, justify?
3.2.P.2. • Firm has performed pharmaceutical • Firm has again submitted pharmaceutical equivalence
2.1 equivalence against the product of applied product against the product Cefspan
Cefspan Capsule 400mg by M/s Capsule 400mg by M/s Barrett Hodgson (Pvt) Ltd and
Barrett Hodgson (Pvt) Ltd. the results of tests are within range.
Justification is required as • No reply submitted
comparator product fails the
dissolution test, then how product is
pharmaceutical equivalent. (Limit
NLT 80%, test result 69.82%.)
• Time point for CDP conducted is 30,
45, 60min. 15 min time point is not
considered being necessary as per
WHO guidelines.
3.2.P.2. Compatibility studies of the Drug The firm have submitted that applied formulation
1.1 Substance(s) with excipients shall be contains colloidal silicon dioxide, magnesium stearate
provided as the qualitative and microcrystalline cellulose as per reference
composition of the formulation is not formulation. The stability studies of the product show
similar to innovator / reference that all the test, physical appearance dissolution and
product. assay are within limits and there are no changes
developed during stability.
3.2.P.5. • Provide signed copy of analytical • The firm submitted that product complies JP
2 methods used for applied product specifications and analytical method and JP
• Justification for proposed analytical monograph is submitted. However, JP monograph for
procedure is required as the official applied product was not submitted and analytical was
monograph is available in JP submitted only for assay test and dissolution test.
• The firm have proposed UV • The firm submitted that there was a typographical
spectrophotometric method for assay mistake we have use the submitted method and HPLC
of drug product while the JP chromatograms are attached. However, no
monograph recommends HPLC for chromatograms were submitted
assay analysis
3.2.P.5. • In finished product specifications The firm submitted that product complies JP
4 under section 3.2.P.5.1 you have specifications and stated that JP monograph is attached.
applied in house specifications while However, no JP monograph was submitted
in Batch Analyses you confirmed
that product complies with USP
specifications, clarify?
3.2.P.6 • The working standard used during • The firm have submitted valid COA of working
analysis states that it should be used standard.
before July 2020 while 3rd month • The firm have submitted COA of primary reference
stability study performed in august standard and standardization of working standard has
2020 and 6th month stability study been performed against the same primary reference
performed at November 2020 using standard.
the same working standard
• The firm have provided COA of
primary reference standard for drug
substance analysis and COA of
working standard. However, the
standardization of working standard
is performed with other Reference
Standards, the COA of which is not
provided
3.2.P.8 • Submit Raw data sheets, COA & • Firm have submitted Raw data sheets, including actual
analytical record for both assay & details of sample solution preparation & standard
dissolution test containing detail of preparation, weight of standard & calculation formula
sample preparation, standard applied for assay test only. Raw data sheets and COA
preparation for various performance for dissolution test containing detail of sample
parameters. preparation, standard preparation for various
• The date of initiation mentioned in performance parameters is not submitted.
stability study is 13.05.2020 while • The firm submitted that there was a typographic
the date of manufacturing mentioned mistake. The initiation date is 18-05-2021 as
in BMR is 18.05.2021. Clarify how mentioned in BMR
stability study started before the
manufacturing of batch.
Previous Decision (321-DRB): Deferred for following:
• Submission of analytical procedures & analytical record for testing of the Drug substance by Drug Product
manufacturer as per USP monograph.
• Submission of Analytical Method Verification studies including specificity, accuracy and repeatability
(method precision) for drug substance performed by the Drug Product manufacturer
• Justification how same batch of drug substance (Batch No. 00243/078/2020) is used both as compacted and
micronized.
• Submission of CDP as per WHO guidelines against innovator product
• Revision of specification as approved by Registration Board in its 313th meeting and notified vide letter No.
F.14-I/2022-PEC dated 14th March 2022.
• Performance of batch analysis as per the monograph approved by Registration Board in its 313 th meeting
and notified vide letter No. F.14-I/2022-PEC dated 14th March 2022.
Evaluation by PEC:
• Firm has submitted analytical procedures and COA of Drug substance for testing of the Drug substance by
Drug Product manufacturer as per USP monograph
• Firm has submitted Analytical Method Verification studies including specificity, accuracy and repeatability
(method precision) for drug substance performed by the Drug Product manufacturer
• The firm submitted that batch Number of Drug substance used is 00244/078/2020 of cefixime compacted.
Firm has submitted COA of Drug substance manufacturer and drug product manufacturer
• Firm has submitted dissolution instead of CDP
• Firm has not submitted revised specification as approved by Registration Board in its 313th meeting and
notified vide letter No. F.14-I/2022-PEC dated 14th March 2022.
• Firm has not submitted performance of batch analysis as per the monograph approved by Registration Board
in its 313th meeting and notified vide letter No. F.14-I/2022-PEC dated 14th March 2022.
Decision: Approved with manufacturer specifications as approved by Registration Board in its 313th
meeting and notified vide letter No. F.14-I/2022-PEC dated 14th March 2022.
Registration Board further decided that registration letter will be issued upon submission of following:
• Performance of analysis as per the monograph approved by Registration Board in its 313 th meeting
and notified vide letter No. F.14-I/2022-PEC dated 14th March 2022 before issuance of registration
letter.
• CDP studies with sampling time points as recommended by relevant guidelines.
• Fee of Rs. 7,500/- for correction/pre-approval change/ in product specifications, as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Case No. 06: Routine application of Human Drugs on Form 5
85. Name and address of manufacture / M/s Iqra Pharmaceuticals., Plot No. 02, Street No. S-9, Natio
Applicant Industrial Zone, Rawat, Islamabad, Pakistan
Brand Name + Dosage Form and Pilzide 600mg Tablet
Strength
Linezolid…………….…600mg
Dairy No. date of R &I fee Form-5 Dy.No 15573 dated 07-03-2019 Rs.20,000/- Dated 07
03-2019
Pharmacological Group Oxazolidinone Antibiotic
Type of form Form 5
Pack size and Demand Price 12’s; As per SRO
Approval status of product in ZYVOX 600mg film coated Tablets USFDA Approved.
Reference Regulatory Authorities
Me-too-status Nezocin Tablets 600mg by M/s Brookes Pharmaceuticals (Reg
No.55005)
GMP Status New License (inspection dated 19-02-2019 the panel unanimou
recommends the grant of DML)
• The firm submitted revised master formulation and removed
addition of overage along with undertaking at the end of form
signed by the technical persons
Decision: Approved with innovator’s specifications. Firm shall submit the fee of Rs. 7,500/-
correction/pre-approval change/ in product specifications, as per notification No.F.7-11/20
Brand Name + Dosage Form and Biopride 50mg Tablets
Strength
Itopride HCl……………….50mg
03-2019
Pharmacological Group Propulsives
Type of form Form 5
Pack size and Demand Price As per SRO
Approval status of product in Ganaton 50mg film coated tablet (PMDA) Japan Approved
Me-too-status Xepride tablet 50mg of M/s Usawa Pharmaceuticals (Reg. #
076818)
Remark of the Evaluator XI •
Decision: Approved with innovator’s specifications. Firm shall submit the fee of Rs. 7,500/-
correction/pre-approval change/ in product specifications, as per notification No.F.7-11/20
Brand Name + Dosage Form and Mcam 7.5mg Tablets
Strength
Meloxicam……………….7.5mg
03-2019
Pharmacological Group Non-steroidal anti-inflammatory drugs (NSAIDs)
Type of form Form-5
Finished product specifications USP
Pack size and Demand Price 1x10’s, 2x10’s; As per SRO
Approval status of product in MOBIC (7.5mg, 15mg) uncoated Tablets USFDA
Reference Regulatory Authorities Approved
Me-too-status Melflam 7.5mg Tablets by M/s Aries Pharmaceuticals
(Reg#84265)
Decision: Approved.
Brand Name + Dosage Form and Airmax 5mg Tablet
Strength
Montelukast Sodium Eq. to Montelukast……………….5mg
03-2019
Pharmacological Group Leukotriene receptor antagonists
Type of form Form 5
Approval status of product in Singulair (4mg, 5 mg) Chewable Tablet USFDA Approved
Me-too-status Nohist Chewable Tablet 5mg by M/s Bio-Mark Pharmaceutica
(Reg.# 85712)
• The firm revised the formulation from film coated tablets
chewable tablets without submission of applicable fee. The fi
submitted revised form 5 and master formulation. The revi
label claim is as under:
Each chewable Tablet Contains:
Montelukast Sodium Eq. to Montelukast……….5mg
Decision: Approved with following label claim:
Each chewable Tablet Contains:
Montelukast Sodium Eq. to Montelukast……….5mg
Firm shall submit the fee of Rs. 30,000/- for correction/pre-approval change in composit
(correction/change of formulation from from film coated to chewable tablets), as per notificati
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form and Q-Flam 50mg Tablet
Strength
Diclofenac potassium……………….50mg
03-2019
Type of form Form 5
Pack size and Demand Price 2x10’s, 3x10’s;As per SRO
Approval status of product in Diclofenac potassium 50mg Film Coated Tablets MHRA
Reference Regulatory Authorities Approved.
Me-too-status Kalfen 50mg tablets by M/s Candid Pharmaceuticals
(Reg#100912)
Remark of the Evaluator XI •
Decision: Approved with change of brand name.
Deferred cases of Human Drugs on Form 5

90. Name and address of M/s Efroze Chemical Industries Pvt Ltd.
manufacture / Applicant 146/23, Korangi Industrial Area, Karachi
Brand Name + Dosage Form Dufanor 10mg Tablet
and Strength
Dydrogesterone………….…10mg
Dairy No. date of R &I fee Form-5 Dy.No 11400 dated 05-03-2019 Rs.20,000/- 05-03-2019
Pharmacological Group Progestogens
Type of form Form 5
Approval status of product in Duphaston 10mg film-coated tablets by M/s Mylan IRE
Reference Regulatory Healthcare Limited (Ireland Approved)
Authorities
Me-too-status Dydrstone 10mg Tablet by M/s Pharmasol (Pvt) Ltd (Reg#096477)
GMP Status GMP certificate issued to Efroze Chemical Industries (Pvt.) Ltd on
dated 03-05-2020 based on inspection conducted on 17-03-2021
Previous Remark of Evaluator XI
• Dydrogesterone is available as Cis and Trans isomer. The firm
did not clarify about the type of isomer that will be used in
formulation. (Trans Isomeric Form active)
• The firm did not provide evidence of required manufacturing
facility / section approval letter for the applied formulation
Previous Decision (307-DRB) Deferred for following:
• Clarification about the type of isomer of Dydrogesterone that will
be used in formulation
• Evidence of required manufacturing facility / section from
Licensing Division
Evaluation by PEC • The firm submitted that they will be using Trans-Isomer of
dydrogesterone in their formulation and provided COA of API
and GMP certificate of supplier M/s Yangzhou Aurisco
Pharmaceutical Co., Ltd China.
• The firm submitted letter No. F. 2-11/2000-Lic (Vol-V) dated
22nd November 2021 issued by Secretary Central Licensing
Board showing the presence of Tablet section (Hormone)
Previous Decision (316-DRB) • Deferred for review of submitted COA of Dydrogesterone for
compliance against the Pharmacopoeial monograph
Evaluation by PEC • The firm submitted that they will be using Trans-Isomer of
dydrogesterone in their formulation and provided COA of API
from supplier M/s Yangzhou Aurisco Pharmaceutical Co., Ltd
China.
• The submitted COA states that the API Dydrogesterone
conforms to EP10.0 standard. The limits and number of tests are
as per European Pharmacopeia monograph
Decision: Deferred for confirmation of already registered products in section of “Tablet
(Hormone) section.)
91. Name and address of M/s Helix Pharma Pvt Ltd. Hakimsons House, A/56, S.I.T.E
manufacturer / Applicant Manghopir Road, Karachi, Pakistan
By
M/s Mediate Pharmaceutical Pvt Ltd. Plot No. 150-151, Sector
24, Korangi Industrial Area, Karchi, Pakistan
Brand Name +Dosage Form + Nurosa Injection 10mg/ml
Strength
Lacosamide…10mg
Diary No. Date of R& I & fee Dy. No. 13056 dated 06.03.2019
Rs. 50,000/- dated 05.03.2019
Pharmacological Group Other antiepileptics
Type of Form Form 5
Finished Product Specification The firm has claimed in-house specs.
Pack size & Demanded Price 1’s (20ml); As per SRO
Approval status of product in Vimpat 10 mg/ml solution for infusion (20ml). Approved in
Reference Regulatory MHRA.
Authorities.
Me-too status Vimpat 10 mg/ml solution for infusion (20ml). Approved in
MHRA.
GMP status Inspected on 16.06.2020 with the following conclusion:
Keeping in view above mentioned rectification status in Liquid
Sterile Ampoule/Infusion/Opthalmic/Otic Section of the firm and
positive intention towards improvement, panel unanimously
“Recommends the Resumption of production in Liquid Sterile
Ampoule/Infusion/Opthalmic/Otic Section”.
Previous Remark of Evaluator • The drug product specifications have not been evaluated.
(Evaluator PEC-IX) • The address in the application is Helix Pharma Pvt Ltd.
Hakimsons House, A/56, S.I.T.E Manghopir Road, Karachi,
Pakistan, while it is Helix Pharma Pvt Ltd., A/56, S.I.T.E
Karachi in the DML.
• Stamped signatures of qualified persons are placed in the
application.
• The firm added vial washing, vial sterilization and vial sealing,
and packing to the manufacturing outlines along with
submission of Rs. 25,000/- fee (challan- 314211675442)
Previous Decision (317-DRB) Deferred for:
• Revision of “Each Vial Contains: Lacosamide…10mg” to
“Each ml contains: Lacosamide…10mg”.
• Submission of differential fee of Rs. 50,000.
• Valid contract manufacturing agreement between the contract
giver and contract acceptor.
Evaluation by PEC • The firm has revised the label claim as:
Each ml contains:
Lacosamide……………10mg
• The firm has submitted differential fee Rs. 50000/- on deposit
slip No#3596152433.
• The firm has submitted copy of contract manufacturing
agreement between the contract giver and contract acceptor
made on 3rd December 2019 valid for a period of three years
from date of agreement.
Decision: Approved with nnovator’s specifications and following label claim:
Each ml contains:
Lacosamide……………10mg
Deferred cases of Veterinary Drugs on Form 5

92. Name and address of M/s Star Laboratories Pvt Ltd. 23-km, Multan Road, Lahore
manufacture / Applicant
Brand Name+Dosage Tylexin M powder
Form+Strength
Composition Each 1000gm powder contains:
Doxycycline HCl…………200gm
Tylosin Tartrate……………100gm
Bromhexine ………………..5mg
Dairy No. date of R &I fee Form-5 Dy.No 8164 dated 25-02-2019 Rs.20,000/- 20-02-
2019
Pharmacological Group Antibiotic & Mucolytic
Type of form Form 5
Finished product Manufacturer’s specifications
specifications
Pack size and Demand Price 100gm, 500gm, 1000gm; As per SRO
Me-too-status T D Shell Water Soluble Powder by M/s. Inshal
Pharmaceutical Industries, (Reg#093236)
GMP Status Decision of the 270th Meeting of CLB:
After thorough discussion/deliberations and recommendation
of the panel of experts in its report dated 14-05-2019, the
Central Licensing Board decided to:
I- Resume production activities in Human Liquid Injection
Section (Genera-Ampoule) Only.
II- However production will remain suspended in Human
Injectable Section (Psychotropic), till the improvements made
by the firm, verification by the panel of experts.
Previous Remark of Evaluator • Letter of deficiencies sent on 29-07-2020 and reminder on
XI
• Master formulation is missing, submit accordingly
• Manufacturing outline is missing, submit accordingly
• You have applied incorrect label claim. The me-too product
contains Each 1000gm powder contains:
Bromhexine HCl…5gm while you have applied for Each ml
contains:
Bromhexine ……..5mg. Revise the label claim as per
available me-too product along with submission of
applicable fee.
• Submission of master formulation of applied product
• Submission of manufacturing outline of applied product
• Revision of the label claim as per available me-too product
along with submission of applicable fee.
Evaluation by PEC • The firm has revised label claim as per available me-too
along with submission of Rs. 30000/- on deposit slip #
9944140616. The revised label claim is as under:
Each 1000gm powder contains:
Bromhexine HCl…5gm
• The firm has submitted master formulation and
manufacturing outline for the applied product.
• The firm has submitted cGMP certificate issued on 20-07-
2020 base on inspection conducted on 24-01-2020
Each 1000gm powder contains:
Bromhexine HCl…5gm
93. Name and address of M/s Star Laboratories Pvt Ltd.23-km, Multan Road, Lahore
Brand Name+Dosage Tylexin powder
Form+Strength
Composition Each kg contains:
Doxycycline HCl………..…200gm
Tylosin Tartrate…………….100gm
Bromhexine ………………..20gm
2019
Type of form Form 5
specifications
Me-too-status T-DOX Water Soluble Powder by M/s Elegance
Pharmaceuticals, (Reg#078285)
XI
• You have applied incorrect label claim. Me-too of applied
product shows the hydrochloride salt of Bromhexine while
the applied formulation contains the base form of
Bromhexine. Clarify or revise the salt form of Bromhexine in
the label claim as per available me-too product along with
submission of applicable fee.
• In label claim you have applied with Doxycycline HCl while
in master formulation you have mentioned Doxycycline
Hyclate, clarify? Furthermore, in master formulation you
have considered the salt factor in case of doxycycline and
tylosin which is not as per label claim, clarify?
• Revision of the label claim as per available me-too product
along with submission of applicable fee.
• Clarification since firm have mentioned Doxycycline HCl in
label claim while Doxycycline Hyclate in master formulation
and considered the salt factor in master formulation in case of
doxycycline and tylosin which is not as per label claim,
Each kg contains:
Bromhexine HCl……………..20gm.
• The firm has submitted revised master formulation and
mentioned correct salt form of doxycycline and revised the
salt factor as per label claim.
Each kg contains:
Bromhexine HCl……………..20gm.
94. Name and address of M/s Star Laboratories Pvt Ltd. 23-km, Multan Road, Lahore
Brand Name+Dosage Colidox T Powder
Form+Strength
Composition Each 100g Contains:
Doxycycline Hyclate…………40gm
Tylosin Tartrate………………20gm
Colistin sulphate……………..10gm
Bromhexine…………………..2gm
2019
Type of form Form 5
specifications
Me-too-status Brocotyd Powder by M/s Univet Pharmaceutical
(Reg#058962)
XI
• 1st page of form 5 is missing
• You have applied incorrect label claim. Me-Too of applied
product shows the hydrochloride salt of Bromhexine while
the applied formulation contains the base form of
Bromhexine. Clarify or revise the salt form of Bromhexine in
the label claim and master formulation as per available me-
too product along with submission of applicable fee.
• Master formulation is missing, submit accordingly
• Manufacturing outline is missing, submit accordingly
• Submission of master formulation of applied product
• Submission of manufacturing outline of applied product
• Revision of label claim as per available me-too product along
with submission of applicable fee.
Each 100g Contains:
Bromhexine HCl………………..2gm
• The firm has submitted master formulation and
manufacturing outline for the applied product.
Each 100g Contains:
Bromhexine HCl………………..2gm
Case No. 07; Registration application of human drugs on Form 5 whose Replies are not received
95. Name and address of manufacture / Applicant M/s Neutro Pharma (Pvt) Ltd.,
Sheikhupura Road, Lahore
Brand Name + Dosage Form and Strength Beclonate 200mcg Rotacaps
Composition Each rotacap contains:
Beclomethasone
dipropionate……..…200mcg
Dairy No. date of R &I fee Form-5 Dy.No 11814 dated 06-03-
2019 Rs.20,000/- Dated 05-03-2019
Pharmacological Group Other Drugs for Obstructive Airway
Diseases, Inhalants (Glucocorticoids)
Type of form Form-5
Finished product specifications BP
Approval status of product in Reference Regulatory Pulvinal Beclometasone
Authorities Dipropionate 200
micrograms/metered dose inhalation
powder (MHRA Approved) ……..as
provided by the firm but could not be
verified
Me-too-status Betatec 200 Rotacaps by M/s
Highnoon Laboratories (Reg#43459)
GMP Status The firm was inspected on 21,23-08-
2017 by a panel of inspectors and
conclusion of inspections was:
Panel inspected the unit and evaluated
documentation regarding production,
quality control and quality assurance.
Panel discussed various technical
aspects with the technical staff at
length. Panel decided to recommend
the renewal of DML of M/s Neutro
Pharma for the approved sections by
the Central Licensing Board.
Remark of the Evaluator XI As per decision of 290th meeting of
Registration Board:
• Provide evidence of separate
manufacturing facility/section for
manufacturing of Rotacaps (DPIs)
including specialized mixing facility
to ensure the required particle size of
the formulation blend.
• Provide evidence of equipments for
performing the test of “Uniformity
of Delivered Dose” and
“Aerodynamic Particle Size
Distribution” as per Pharmacopoeia.
• Provide description of Drug
Delivery Device, which is
compatible with the intended
product and will be used for
delivering the required “Target
Delivery Dose”.
• Submit the label claim for “Target
Delivery Dose” based upon the
studies with the intended delivery
system under defined test conditions
(i.e., flow rate, duration).
• Provide evidence of approval of
applied formulation in reference
regulatory authorities / agencies
which were adopted by the
Registration Board in its 275th
meeting along with weblink.
• Undertaking at the end of form 5 is
missing.
• The applicant have claimed
manufacturer’s specifications but
the official monograph is available
in BP.
Brand Name + Dosage Form and Strength Beclotide 100mcg Rotacaps
Composition Each rotacap Contains:
Beclomethasone
dipropionate…….100mcg
2019 Rs.20,000/- Dated 05-03-2019
Type of form Form-5
powder (MHRA Approved) ……..as
verified
Registration Board:
Delivery Dose”.
missing.
in BP.
Brand Name + Dosage Form and Strength Beclonate 400mcg Rotacaps
Beclomethasone
dipropionate………400mcg
2019 Rs.20,000/- Dated 05-03-2019
Type of form Form-5
Pack size and Demand Price 30’S; As per SRO
powder (MHRA Approved)……..as
verified
Registration Board:
Delivery Dose”.
missing.
in BP.
Brand Name + Dosage Form and Strength Bisonid 400 mcg Rotacaps
Budesonide………….400mcg
2019 Rs.20,000/- Dated 05-03-2019
Type of form Form-5
Approval status of product in Reference Regulatory Budesonide 400 Micrograms Dry
Authorities Powder Inhaler (MHRA Approved)
……..as provided by the firm but
could not be verified
Me-too-status Budevair 400 Rotacaps by M/s
Registration Board:
Delivery Dose”.
missing.
Brand Name + Dosage Form and Strength Bisonid 100 mcg Rota Caps
Budesonide……..…100mcg
2019 Rs.20,000/- Dated 05-03-2019
Type of form Form-5
XI
Remark of the Evaluator As per decision of 290th meeting of
Registration Board:
Delivery Dose”.
missing.
Brand Name + Dosage Form and Strength Bisonid 200 mcg Rotacaps
Budesonide………..…200mcg
2019 Rs.20,000/- Dated 05-03-2019
Type of form Form-5
Registration Board:
Delivery Dose”.
missing.
Brand Name + Dosage Form and Strength Bisonid-F 100mcg/6mcg Rotacaps
Budesonide…………..100mcg
Formoterol fumarate…..…6mcg
2019 Rs.20,000/- Dated 05-03-2019
Pharmacological Group Adrenergics, Inhalants (Adrenergics
in combination with corticosteroids
or other drugs, excl. anticholinergics)
Type of form Form-5
Approval status of product in Reference Regulatory Symbicort 100mcg/6mcg Turbohaler,
Authorities Inhalation Powder (MHRA
Approved)
Me-too-status Combivair 100 Rotacaps by M/s
Highnoon Laboratories
(Reg#054311)
XI
Registration Board:
Delivery Dose”.
• The reference formulation have
mentioned the hydrated form
(dihydrate) of Formoterol fumarate
in the label claim while you have
not mentioned the hydrated form.
Revise the label claim as per
reference formulation mentioning
the hydrated form along with
Brand Name + Dosage Form and Strength Bisonid-F 200mcg/6mcg Rotacaps
Budesonide………….200mcg
Formoterol fumarate……..…6mcg
2019 Rs.20,000/- Dated 05-03-2019
Pharmacological Group Adrenergics, Inhalants (Adrenergics
in combination with corticosteroids
or other drugs, excl. anticholinergics)
Type of form Form-5
Approval status of product in Reference Regulatory Symbicort 200mcg/6mcg Turbohaler,
Authorities Inhalation Powder (MHRA
Approved)
Me-too-status Combivair 200 Rotacaps by M/s
Highnoon Laboratories Ltd
(Reg#054316)
Registration Board:
Delivery Dose”.
• Form 5 is missing.
• The reference formulation have
mentioned the hydrated form
(dihydrate) of Formoterol fumarate
in the label claim while you have
not mentioned the hydrated form.
reference formulation mentioning
the hydrated form along with
Brand Name + Dosage Form and Strength Stardi Tablets 0.035mg/2mg Tablet
Composition Each film coated tablet contains:
Cyproterone Acetate……..2mg
Ethinylestradiol…………..0.035mg
2019 Rs.20,000/- Dated 05-03-2019
Pharmacological Group Estrogen / Anti-androgen
Type of form Form-5
Pack size and Demand Price 5x10’s; As per SRO
Approval status of product in Reference Regulatory Co-Cyprindiol 2000/35 film coated
Authorities Tablets (MHRA approved)
Me-too-status Fam-21 Tablet by M/s Pharma Health
(Reg.#77106)
missing.
• Evidence of manufacturing
facility/section approval for the
applied formulation i.e. Steroidal
Tablet section
Brand Name + Dosage Form and Strength Meste 25mg Tablet
Exemestane………….25mg
2019 Rs.20,000/- Dated 05-03-2019
Pharmacological Group Aromatase Inhibitor
Type of form Form-5
Approval status of product in Reference Regulatory Exemestane 25mg Film-coated
Authorities Tablets (MHRA Approved)
Me-too-status PH&T Exemestane 25mg coated
tablets of M/s Mehran
International (Reg. # 078122) (does
not depict film coating)
Tablet section.
Brand Name + Dosage Form and Strength Finsat 1mg Tablet
Finasteride ……….…1mg
2019 Rs.20,000/- Dated 05-03-2019
Pharmacological Group Drugs Used In Benign Prostatic
Hypertrophy
G04CB01 Testosterone-5-alpha
reductase inhibitors
Type of form Form-5
Approval status of product in Reference Regulatory Finasteride 1mg Film-coated Tablets
Authorities (MHRA Approved)
Me-too-status Prosin Tablet by M/s Himont
Pharmaceutical (Reg#83852)
Tablet section.
• Master formulation and
manufacturing outline not
submitted
Brand Name + Dosage Form and Strength Salzone 50mcg/25mcg Rotacap
Fluticasone Propionate……50mcg
Salmeterol (as
Xinafoate)……..25mcg
2019 Rs.20,000/- Dated 05-03-2019
Pharmacological Group Adrenergics in combination with
corticosteroids or other
drugs, excluding Anticholinergics.
Type of form Form-5
Pack size and Demand Price 30’S; As per SRO
Approval status of product in Reference Regulatory Seretide Evohaler 25 microgram/50
Authorities microgram per metered dose
pressurised inhalation, suspension
(MHRA Approved)
Me-too-status Wiltide Plus 25/50Mcg Automized
Capsules by M/s Wilson’s
Pharmaceuticals (Reg. #38486)
Registration Board:
Delivery Dose”.
missing.
• The firm has claimed
manufacturer’s specifications and
the product is available in USP.
Brand Name + Dosage Form and Strength Salzone 250mcg/25mcg Rotacap
Fluticasone
Propionate………..250mcg
Salmeterol (as
Xinafoate)………25mcg
2019 Rs.20,000/- Dated 05-03-2019
corticosteroids or other
drugs, excluding Anticholinergics.
Type of form Form-5
Approval status of product in Reference Regulatory Seretide Evohaler 25 microgram/250
Authorities microgram per metered dose
pressurised inhalation, suspension
(MHRA Approved)
Me-too-status Wiltide Plus 25/250Mcg Automized
Powder capsules by M/s Wilson’s
Registration Board:
Delivery Dose”.
missing.
• The firm has claimed
manufacturer’s specifications and
the product is available in USP.
Brand Name + Dosage Form and Strength Gestyl Plus Tablet 0.075mg/0.02mg
Gestodene………….0.075mg
Ethinylestradiol……...0.02mg
2019 Rs.20,000/- Dated 05-03-2019
Pharmacological Group Hormonal contraceptives for
systemic use, (progestogens and
estrogens, fixed combinations)
Type of form Form-5
Finished product specifications Manufacturing specifications
Approval status of product in Reference Regulatory Aidulan 20/75 microgram film-
Authorities coated tablets (MHRA
Approved)
Me-too-status Meliane Tablets by M/s Medipharm
(Pvt) Ltd (Reg#024076) (doesnot
depict coating)
Remark of the Evaluator XI • Evidence of manufacturing
Tablet section.
missing.
Brand Name + Dosage Form and Strength Saydocit Sachet
Composition Each sachet contains:
Sodium bicarbonate…….0.428g/g
Citric Acid……………...0.176g/g
Sodium citrate…………0.153g/g
Tartaric Acid…………..0.215g/g
2019 Rs.20,000/- Dated 05-03-2019
Pharmacological Group Antacids & Antiflatulents
Type of form Form-5
Finished product specifications Manufacturer’s Specifications
Pack size and Demand Price 20’s, 100’s; As per SRO
Approval status of product in Reference Regulatory
Authorities
Me-too-status Citro-soda of Abbott laboratories (as
provided by the
Firm but strength of ingredients is
different)
Remark of the Evaluator XI • Undertaking at the end of form 5 is
missing.
• Evidence of approval of applied
formulation in reference regulatory
authorities/agencies which were
declared/approved by the
meeting along with weblink
• Evidence of applied
formulation/drug already approved
by DRAP (generic / me-too status)
alongwith registration number,
brand name and name of firm as the
provided me too contains
ingredients in different strengths.
Brand Name + Dosage Form and Strength Tromo Rota Capsule 0.18mcg
Tiotropium bromide
monohydrate…0.18mcg
2019 Rs.20,000/- Dated 05-03-2019
Pharmacological Group Anticholinergic
Type of form Form-5
Finished product specifications Manufacturer specification
Pack size and Demand Price 10’s, 15’s, 20’s: As per SRO
Approval status of product in Reference Regulatory SPIRIVA tiotropium 18 microgram
Authorities powder for inhalation (in capsule)
(TGA Australia Approved)
Me-too-status Tiovair Rotacaps by M/s Highnoon
Laboratories (Reg#54315)
Registration Board:
Delivery Dose”.
• You have applied for label claim
Tiotropium bromide
monohydrate…0.18mcg while
reference formulation contain
Tiotropium bromide monohydrate
equivalent to Tiotropium …18mcg.
reference formulation along with
Furthermore revise the master
formulation adjusting the weight of
API considering the hydrated form.
missing.
111. Name and address of manufacture / Applicant M/s Wimits Pharmaceuticals (Pvt.)
Ltd., Plot No. 129, Sundar Industrial
Estate, Raiwind Road, Lahore
Brand Name + Dosage Form and Strength Provinate Ointment
Composition Each gram contains:
Gentamicin (as sulphate) ………..
1mg (0.1% w/w)
Betamethasone (as valerate)……..
1mg (0.1% w/w)
2019 Rs.20,000 Dated 06-03-2019
Pharmacological Group Antibiotic+Corticosteroid
Type of form Form-5
Pack size and Demand Price 15g, 30g; As per SRO
Approval status of product in Reference Regulatory Valisone-G Ointment Health Canada
Authorities Approved
Me-too-status Genticyn B Ointment by M/s Reckitt
& Colman (Reg#010185)
GMP Status cGMP certificate issued to firm on the
basis of evaluation conducted on 08-
09-2021
Remark of the Evaluator XI • Firm has
Cream/Ointment/Lotion/Gel
(General) section as per Sceretary
CLB Letter No. F. 1-10/2012-Lic
dated 07th june 2022.
• Revise the weight of API in master
formulation considering the salt
factor. In label claim you have
applied Gentamicin (as sulphate)
…1mg (0.1% w/w). However in
master formulation gentamicin
mentioned as gentamicin sulphate
0.5%, clarify?
Decision: Approved.
• Firm shall submit revised master formulation mentioning correct strength of
gentamycin sulphate as per submitted label claim before issuance of registration letter.
• Firm shall submit fee of Rs.30,000/- for correction/pre-approval change in the master
formulation, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form and Strength Difluzim-D cream
Diflucortolone valerate ……..… 1mg
Isoconazole Nitrate …………….
10mg
2019 Rs.20,000 Dated 06-03-2019
Pharmacological Group Corticosteroid, Antifungal
Type of form Form-5
Finished product specifications Manufacturer’s Specification
Pack size and Demand Price 10g, 15g, 30g, 45g; As per SRO
Approval status of product in Reference Regulatory Travocort 0.1 + 1% w/w Cream
Authorities (AIFA Italy Approved)
Me-too-status Difzole Cream by M/s Vega
09-2021
dated 07th june 2022.In master
formulation mometasone furoate is
mentioned as the active
ingredients, clarify?
• Firm shall submit revised master formulation mentioning correct API before issuance
of registration letter.
• Firm shall submit fee of Rs.30,000/- for correction/pre-approval change in the master
formulation and product specifications, as per notification No.F.7-11/2012-B&A/DRAP
dated 13-07-2021.
Brand Name + Dosage Form and Strength Eflowim 13.9% w/w cream
Eflomit 13.9% w/w cream
Composition Each g contains:
Eflornithine Hydrochloride ……..…
139mg (13.9% w/w)
2019 Rs.20,000 Dated 06-03-2019
Pharmacological Group Anti-Hirsutism Agent
Type of form Form-5
Pack size and Demand Price 10g, 15g, 30g,45g; As per SRO
Approval status of product in Reference Regulatory VANIQA (13.9%) Cream, USFDA
Me-too-status Hairid Cream by M/s Saffron
Pharma, (Reg#85721)
09-2021
• You have applied incorrect label
claim. The reference formulation
contain 13.9% (139 mg/g) of
anhydrous eflornithine
hydrochloride as eflornithine
hydrochloride monohydrate (150
mg/g) while you have applied
eflornithine hydrochloride only and
not considering the hydrochloride
and monohydrate form. Revise the
label claim as per reference
formulation along with submission
of applicable fee.
• In master formulation hydroquinine
is mentioned as the active
ingredients, clarify?
Each g contains:
Eflornithine Hydrochloride as monohydrate……..… 139mg (13.9% w/w)
• Submission of revised master formulation as per applied product before issuance of
registration letter
• Firm shall submit the fee of Rs. 30,000/- for correction/pre-approval change in
composition (correction/change of hydrated form of the drug substance), as per
Brand Name + Dosage Form and Strength Fuvate 0.1% w/w cream
Fuvim 0.1% w/w cream
Composition Each gm contains:
Mometasone Furoate…………..1 mg
(0.1%)
2019 Rs.20,000 Dated 06-03-2019
Type of form Form-5
Pack size and Demand Price 15g, 30g, 45g; As per SRO
Approval status of product in Reference Regulatory ELOCON 0.1% w/w Cream for
Authorities topical use USFDA Approved
Me-too-status Edme Cream by Amarant
Pharmaceuticals (Reg #67020)
09-2021
• Revise the 1st page of form 5 as per
prescribed format.
•
• Firm has
Decision: Approved. Firm shall submit 1st page of form 5 as per prescribed format before
issuance of registration letter along with applicable fee for revision of Form 5, as per
Brand Name + Dosage Form and Strength Polywim Ointment
Polymit Ointment
Polymyxin B Sulphate
…………..10000IU
Bacitracin Zinc ………………
500IU
2019 Rs.20,000 Dated 06-03-2019
Pharmacological Group Antibacterials
Type of form Form-5
Approval status of product in Reference Regulatory Polyfax Ointment MHRA Approved
Authorities
Me-too-status Multifax Ointment by Xenon
09-2021.
Remark of the Evaluator XI • Revise the 1st page of form 5 as per
prescribed format.
• Firm has Cream/Ointment/
Lotion/Gel (General) section as per
Sceretary CLB Letter No. F. 1-
10/2012-Lic dated 07th june 2022.
st
Decision: Approved. Firm shall submit 1 page of form 5 as per prescribed format before
Brand Name + Dosage Form and Strength Quaz 1% w/w cream
Quazim 1% w/w Cream
Silver Sulphadiazine ……….10mg
2019 Rs.20,000 Dated 06-03-2019
Pharmacological Group Antibiotics And Chemotherapeutics
For Dermatological Use
Type of form Form-5
Approval status of product in Reference Regulatory Flamazine Cream 1%w/w MHRA
Me-too-status Derma 1% w/w Cream by M/s
Mafins Pharma (Reg#81178)
09-2021
• Revise the 1st page of form 5 as per
prescribed format.
•
• Firm has
117. Name and address of manufacture / Applicant M/s Trigon Pharmaceuticals Pvt
Limited., 8 km, Thoker Raiwind
Road, Lahore
Brand Name + Dosage Form and Strength Azabex 200mg Tablet
Composition Each film coated Tablet Contains:

Carbamazepine……200mg
Dairy No. date of R &I fee Form-5 Dy.No 16324 da ted 07-03-
2019 Rs.20,000/- Dated 06-03-2019
Pharmacological Group Antiepileptics
Type of form Form-5
Approval status of product in Reference Regulatory Carbagen 200mg tablets MHRA
Me-too-status Carbawel 200 mg Tablets by M/s
Welmark Pharmaceuticals
(Reg#77462)
GMP Status The firm was inspected on 25-03-
2019 and Conclusion of inspection
was:
Based on the areas inspected, the
people met and the documents
reviewed, and considering the
findings of inspection M/s Trigon
Pharmaceuticals Pvt Ltd Lahore was
considered to be operating at a
satisfactory level of GMP compliance
with refrence to GMP guidelines as
per Dugs Act, 1976 and rules framed
there under.
• The firm has applied for
in USP.
• You have applied for film coated
tablet but the reference formulation
is uncoated. Revise the label claim
and master formulation along with
Decision: Approved with USP specifications and following label claim:
Each Tablet Contains:
Carbamazepine……200mg
specifications and correction/pre-approval change in composition (correction/change of
formulation from film coated tablet to un-coated tablet) as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021.
• Submission of GMP audit report of the firm from QA&LT Division, valid within last
three years
Road, Lahore
Brand Name + Dosage Form and Strength Rotavin 40mg/2ml Injection
Drotaverine HCl…..…40mg
2019 Rs.20,000/- Dated 06-03-2019
Pharmacological Group Drugs for functional gastrointestinal
disorders
Type of form Form-5
Pack size and Demand Price 10x4ml, 25x2ml; As per SRO
Authorities
Me-too-status Hi-Spa 40mg/2ml injection of M/s
Helix Karachi
(Reg.#073604)
was:
there under.
Remark of the Evaluator XI • You have applied for two different
volume i.e. 2ml and 4ml in same
application, mention only a single
volume.
• Submit complete manufacturing
outline
• Mention type of primary packaging
material of applied formulation
whether it is type I, II or III glass
container
Road, Lahore
Brand Name + Dosage Form and Strength Diflozin 25mg Tablet
Composition Each tablet contains:
Empagliflozin ……..…25mg
2019 Rs.20,000/- Dated 06-03-2019
Pharmacological Group Blood Glucose Lowering Drugs,
Excl. Insulins
Type of form Form-5
Approval status of product in Reference Regulatory JARDIANCE (10mg, 25mg) film-
Authorities coated tablets USFDA Approved
Me-too-status Empoli 25mg Tablet by M/s Sami
was:
there under.
claim. The reference formulation is
film coated while you have applied
for uncoated tablets. Revise the
of applicable fee.
• You have not mentioned coating,
blistering and packing in
manufacturing outline. Submit
complete manufacturing outline.
• Submission of stability studies data
of three batches as per
Requirements of Registration
Board decision of 293rd meeting.
Decision: Registration Board deferred the case for submission of reply to above cited
shortcomings along with stability studies data as per checklist of 293rd meeting of DRB,
in light of the Notifdication No. 320-DRB/ 2022(PE&R) dated 17th October 2022.
Road, Lahore
Brand Name + Dosage Form and Strength Lamot 50mg Tablet
Lamotrigine……….50mg
2019 Rs.20,000/- Dated 06-03-2019
Pharmacological Group Other antiepileptics
Type of form Form-5
Approval status of product in Reference Regulatory LAMICTAL 50mg Tablets (USFDA
Authorities approved)
Discontinued **Federal Register
determination that product was not
discontinued or withdrawn for safety
or efficacy reasons**
Me-too-status Epictal 50mg Tablet of M/s Pakistan
was:
there under.
Remark of the Evaluator XI • The firm have applied for
the official monograph for the
applied product is available in
USP.
three years
Road, Lahore
Brand Name + Dosage Form and Strength Lemox 20mg Tablet
Olmesartan Medoxomil………20mg
2019 Rs.20,000/- Dated 06-03-2019
Pharmacological Group Angiotensin II receptor blockers
(ARBs)
Type of form Form-5
Approval status of product in Reference Regulatory BENICAR tablets USFDA Approved
Authorities
Me-too-status Olmisan 20mg tablets by Highnoon
Laboratories (Reg. 092273)
was:
there under.
• The firm have applied for
the official monograph for the
applied product is available in
USP.
of applicable fee.
Decision: Approved with USP specifications and following label claim:
Each film coated tablet contains:
Olmesartan Medoxomil………20mg
formulation from un-coated tablet to film coated tablet) as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021.
three years
Road, Lahore
Brand Name + Dosage Form and Strength Cetarac 800mg Tablet
Piracetam……….…800mg
2019 Rs.20,000/- Dated 06-03-2019
Pharmacological Group Other psychostimulants and
nootropics
Type of form Form-5
Finished product specifications Manufacturer’s specification
Approval status of product in Reference Regulatory Nootropil 800 mg film-coated
Authorities Tablets (MHRA Approved)
Me-too-status Nootropil Tablet 800mg by M/s GSK
(Reg# 82277)
was:
there under.
Remark of the Evaluator XI • You have applied incorrect label
of applicable fee.
Piracetam……….…800mg
composition (correction/change of formulation from un-coated tablet to film coated
tablet) as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
• Firm shall submit complete manufacturing outline before issuance of registration letter
three years
Road, Lahore
Brand Name + Dosage Form and Strength Perbex 20mg Tablet
Rabeprazole Sodium………..20mg
2019 Rs.20,000/- Dated 06-03-2019
Pharmacological Group Proton pump inhibitors
Type of form Form-5
Approval status of product in Reference Regulatory Rabeprazole 20mg Gastro-resistant
Authorities Tablets MHRA approved
Me-too-status Rabro 20mg Tablet by M/s Genix
Pharma (Reg#83775)
was:
there under.
enteric coated while you have
applied for uncoated tablets. Revise
the label claim as per reference
of applicable fee.
Each enteric coated tablet contains:
Rabeprazole Sodium………..20mg
composition (correction/change of formulation from un-coated tablet to enteric coated
tablet), as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
three years
Road, Lahore
Brand Name + Dosage Form and Strength Rivox 200mg Tablet
Rifaximin………..…200mg
2019 Rs.20,000/- Dated 06-03-2019
Pharmacological Group Antibiotics
Type of form Form-5
Approval status of product in Reference Regulatory XIFAXAN (200mg, 550mg) film-
Authorities coated tablets, USFDA approved
Me-too-status Nimixa 200mg film-coated tablet by
M/s Getz Pharma (Reg# 70734)
was:
there under.
of applicable fee.
Rifaximin………..…200mg
11/2012-B&A/DRAP dated 13-07-2021.
three years
Road, Lahore
Brand Name + Dosage Form and Strength Faxet 10mg Tablet
Rivaroxaban……………10mg
2019 Rs.20,000/- Dated 06-03-2019
Pharmacological Group Antithrombotic Agents
Type of form Form-5
Approval status of product in Reference Regulatory Xarelto film-coated tablets (2.5mg,
Authorities 10mg, 15mg, 20mg) by USFDA
Approved.
Me-too-status Roxaban 10mg Tablet by M/s
Genetics Pharmaceuticals (Reg#
85163)
was:
there under.
of applicable fee.
Rivaroxaban……………10mg
11/2012-B&A/DRAP dated 13-07-2021.
three years
Road, Lahore
Brand Name + Dosage Form and Strength Rovastin 10mg Tablet
Rosuvastatin
Calcium………..…10mg
2019 Rs.20,000/- Dated 06-03-2019
Pharmacological Group HMG CoA reductase inhibitors
Type of form Form-5
Approval status of product in Reference Regulatory CRESTOR (5, 10, 20, or 40 mg) film
Me-too-status R-Vastin-10 Tablet by M/s Rasco
Pharma, (Reg#80208)
was:
there under.
Remark of the Evaluator XI • You have applied for label claim
Each tablet contains:
Rosuvastatin Calcium….…10mg
while the reference formulation
contain Each film coated tablet
contains:
Rosuvastatin as
Calcium….…10mg. Revise the
of applicable fee.
Rosuvastatin as Calcium………..…10mg
• Firm shall submit the differential fee of Rs. 30,000/- for correction/pre-approval change
in composition (correction/change of salt factor of the drug substance) and change of
formulation from un-coated tablet to film coated tablet, as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021.
three years
Road, Lahore
Brand Name + Dosage Form and Strength Rovastin 5mg Tablet
Rosuvastatin Calcium…………5mg
2019 Rs.20,000/- Dated 06-03-2019
Type of form Form-5
Pack size and Demand Price 1x10’s, 2x10’s, 3x10’s; As per SRO
Approval status of product in Reference Regulatory CRESTOR (5, 10, 20, or 40 mg) film
Me-too-status R-Vastin-5 Tablet by M/s Rasco
Pharma, (Reg#80210)
was:
there under.
Remark of the Evaluator XI • You have applied for label claim
Rosuvastatin Calcium….…5mg
while the reference formulation
contain Each film coated tablet
contains:
Rosuvastatin as Calcium….…5mg.
Rosuvastatin as Calcium………..…5mg
in composition (correction/change of salt factor of the drug substance) and change of
formulation from un-coated tablet to film coated tablet, as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021.
three years
Road, Lahore
Brand Name + Dosage Form and Strength Primot 25mg Tablet
Topiramate…………25mg
2019 Rs.20,000/- Dated 06-03-2019
Pharmacological Group Antiepileptics
Type of form Form 5
Approval status of product in Reference Regulatory Topiramate Cadila 25mg film-coated
Authorities tablets MHRA Approved
Me-too-status Neutop 25mg tablets by M/s
Nabiqasim Industries (Reg#076387)
was:
there under.
of applicable fee.
Topiramate…………25mg
three years
129. Name and address of manufacture / Applicant M/s Medimarker's Laboratories Pvt
Ltd., A-104, S.I.T.E Area, Hyderabad
Brand Name + Dosage Form and Strength Markxim Dry Powder 500mg
Injection IV

Cefotaxime
Sodium…………...500mg
2019 Rs.20,000/- Dated 21-02-2019
Pharmacological Group Cephalosporine
Type of form Form 5
Approval status of product in Reference Regulatory Cefotaxime 500mg powder for
Authorities solution for injection/infusion MHRA
Approved
Me-too-status Efatax 500mg Injection by M/s Cure
Laboratories (Reg# 098017)
GMP Status
prescribed format
• Firm has Injectable section
(Cephalosporine) as per Sceretary
(Vol-I) dated 03rd December 2018.
claim. Revise the label claim after
considering the salt factor as per
• Submit latest GMP Inspection
report conducted within last three
years
Each Vial Contains:
Cefotaxime as Sodium…………...500mg
• Firm shall submit 1st page of form 5 as per prescribed format alonwith GMP audit
report of the firm from QA&LT Division, valid within last three years
composition (correction/change of salt factor of the drug substance), as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form and Strength Rifodime Dry Powder Injection
500mg
Ceftazidime
Pentahydrate…….…500mg
2019 Rs.20,000/- Dated 21-02-2019
Type of form Form 5
Approval status of product in Reference Regulatory Ceftazidime 500mg Powder for
Authorities Solution for Injection MHRA
Approved
Me-too-status Kefamin Injection 500mg IM/IV by
M/s Maxitech Pharma (Reg# 097038)
GMP Status
prescribed format
considering the hydrated form as
per reference formulation along
years
Each Vial Contains:
Ceftazidime as Pentahydrate…….…500mg
• Firm shall submit 1st page of form 5 as per prescribed format alonwith GMP audit
composition (correction/change of hydrated factor of the drug substance), as per
Brand Name + Dosage Form and Strength Cefmark Dry Powder Injection
500mg IV
Ceftriaxone Sodium…………500mg
2019 Rs.20,000/- Dated 21-02-2019
Pharmacological Group Cephalosporin
Type of form Form 5
Approval status of product in Reference Regulatory Ceftriaxone 500mg powder for
Authorities solution for injection MHRA
Approved
Me-too-status Ceftro Injection 500mg IV by Curexa
Health, (Reg#82738)
GMP Status
prescribed format
considering the salt factor as per
years
Each Vial Contains:
Ceftriaxone as Sodium…………500mg
• Firm shall submit 1st page of form 5 as per prescribed format alongwith GMP audit
composition (correction/change of salt factor of the drug substance), as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form and Strength Halexin Dry Powder Suspension
125mg/5ml
Cephalexin
Monohydrate…………..125mg
2019 Rs.20,000/- Dated 21-02-2019
Type of form Form 5
Approval status of product in Reference Regulatory Cefalexin 125mg/5ml Powder for
Authorities Oral Suspension MHRA Approved
Me-too-status Imlax 125mg Dry Powder
Suspension by M/s Daneen Pharma
(Reg#101555)
GMP Status
prescribed format
• Firm has Dry syrup section
years
Each 5ml contains:
Cephalexin as Monohydrate…………..125mg
composition (correction/change of hydrated factor of the drug substance), as per
Brand Name + Dosage Form and Strength Halexin Dry Powder Suspension
250mg/5ml
Cephalexin
Monohydrate……….250mg
2019 Rs.20,000/- Dated 21-02-2019
Type of form Form 5
Approval status of product in Reference Regulatory Cefalexin 250mg/5ml Powder for
Me-too-status Imlax 250mg Dry Powder
Suspension by M/s Daneen Pharma
(Reg# 101556)
GMP Status
prescribed format
• Firm has Dry syrup section
years
Each 5ml contains:
Cephalexin as Monohydrate…………..250mg
in composition (correction/change of hydrated factor of the drug substance), as per
134. Name and address of manufacture / Applicant M/s Baxter Pharmaceuticals., A-1/A,
Scheem No.33,Phase-1,S.I.T.E,Super
Highway, Karachi
Brand Name + Dosage Form and Strength Fexodine 120mg Tablet
Fexofenadine as
HCl………..…120mg
2019 Rs.20,000/- Dated 19-02-2019
Pharmacological Group Antihistamines
Type of form Form-5
Approval status of product in Reference Regulatory Telfast 120mg film-coated tablets,
Authorities MHRA Approved.
Me-too-status Axofed 120mg Tablet by M/s Akson
Pharmaceuticals, (Reg# 101789)
GMP Status
prescribed format
• The reference formulation is film
coated while you have applied for
uncoated tablets. Revise the label
claim, master formulation and
manufacturing outline as per
Furthermore, you have applied the
label claim considering the salt
factor. Revise the label claim
without considering the salt factor
along with submission of applicable
fee.
years
Decision: Registration Board deferred the case for following:
• Submission of reply to the above cited shortcomings within six months.
• Verification of validity status of DML from Licensing Divison.
Highway, Karachi
Fexofenadine as HCl…………60mg
2019 Rs.20,000/- Dated 19-02-2019
Type of form Form-5
Approval status of product in Reference Regulatory FEXOTABS 60mg film coated tablet,
Authorities TGA Approved.
GMP Status
prescribed format
fee.
years
Highway, Karachi
Fexofenadine as HCl…….…180mg
2019 Rs.20,000/- Dated 19-02-2019
Type of form Form-5
Approval status of product in Reference Regulatory FEXOTABS 180mg film coated
Authorities tablet, TGA Approved.
GMP Status
prescribed format
fee.
years
Highway, Karachi
Brand Name + Dosage Form and Strength Nacdium Gel 2gm
Composition Each 100gm Contains:
Diclofenac diethylamine ammonium
salt as Diclofenac
Sodium……………….2gm (2%w/w)
2018 Rs.20,000/- Dated 13-09-2018
Pharmacological Group NSAIDS
Type of form Form 5
Pack size and Demand Price 20gm, 100gm; As per SRO
Approval status of product in Reference Regulatory Voltarol 12 Hour Emulgel 2.32% Gel
Authorities MHRA Approved
Me-too-status Diclofil Gel by M/s Murfy
Pharmaceuticals (Reg# 049917)
GMP Status
prescribed format duly signed by
the signatory
• Submit manufacturing procedure for
the applied product
• Provide evidence of required
manufacturing facility/section
approval letter
years
Highway, Karachi
Brand Name + Dosage Form and Strength RapidCam 8mg Tablet
Lornoxicam…………..8mg
2019 Rs.20,000/- Dated 19-02-2019
Type of form Form 5
Finished product specifications Innovator’s specifications
Approval status of product in Reference Regulatory Xefo 8mg film-coated tablet (EMA
Me-too-status Lufam 8mg Tablet by M/s Martin
Dow Ltd (Reg# 083309)
GMP Status
prescribed format
• You have applied for uncoated
tablets while the reference
formulation is film coated. Revise
the label claim, master formulation
and manufacturing outline as per
years
• Submission of reply to the above cited shortcomings within six months.Verification of
validity status of DML from Licensing Divison.
Highway, Karachi
Brand Name + Dosage Form and Strength Atrolip 10mg Tablet
Atorvastatin……………..10mg
2019 Rs.20,000/- Dated 19-02-2019
Type of form Form 5
Approval status of product in Reference Regulatory Lipitor 10mg film-coated tablets
Me-too-status Atorviz 10mg tablets by Tabros
Pharma (Reg#098542)
GMP Status
prescribed format
Furthermore, mention the salt and
hydrated form of atorvastatin in the
label claim along with submission
of applicable fee.
years
Highway, Karachi
Atorvastatin……………..20mg
2019 Rs.20,000/- Dated 19-02-2019
Type of form Form 5
Pharma (Reg#098541)
GMP Status
prescribed format
of applicable fee.
years
Highway, Karachi
Atorvastatin………….…40mg
2019 Rs.20,000/- Dated 19-02-2019
Type of form Form 5
Pharma (Reg#098540)
GMP Status
prescribed format
of applicable fee.
years
Highway, Karachi
Brand Name + Dosage Form and Strength Erythrobax 500mg Tablet
Composition Each 5ml Contains:
Erythromycin Stearate……500mg
2019 Rs.20,000/- Dated 19-02-2019
Pharmacological Group Macrolides
Type of form Form 5
Approval status of product in Reference Regulatory Erythrocin 500 film coated tablets
Me-too-status Wotez 500mg Tablet by M/s Martin
Dow Marker Ltd (Reg#090772)
GMP Status
prescribed format
• The cover letter, fee challan and 1st
page of form 5 shows that you have
applied for tablet while the label
claim shows that you have applied
for suspension/solution, clarify and
years
Highway, Karachi
Brand Name + Dosage Form and Strength Erythrobax 250mg Tablet
Erythromycin (Stearate)…250mg
2019 Rs.20,000/- Dated 19-02-2019
Type of form Form 5
Approval status of product in Reference Regulatory Erythrocin 250 film coated tablets
Me-too-status Wotez 250mg Tablet by M/s Martin
Dow Marker Ltd (Reg#090773)
GMP Status
prescribed format
• The cover letter, fee challan and 1st
page of form 5 shows that you have
applied for tablet while the label
claim shows that you have applied
for suspension/solution, clarify and
years
Highway, Karachi
Brand Name + Dosage Form and Strength Zoline 400mg Tablet
Linezolid…………400mg
2019 Rs.20,000/- Dated 19-02-2019
Pharmacological Group Oxazolidinone Antibacterial
Type of form Form 5
Approval status of product in Reference Regulatory ZYVOX 400mg film-coated tablets
Authorities Tablet USFDA Approved.
or efficacy reasons* (as per USFDA
website)
Me-too-status Zvox 400mg Tablet by M/s Arreta
Pharmaceuticals (Reg# 084279)
GMP Status
prescribed format
years
Highway, Karachi
Brand Name + Dosage Form and Strength Lowstat 20mg Tablet
Simvastatin………….…20mg
2019 Rs.20,000/- Dated 19-02-2019
Type of form Form 5
Approval status of product in Reference Regulatory Simvastatin 20mg film coated
Authorities Tablets MHRA Approved
Me-too-status Simvital 20mg Tablet by M/s Lisko
Pakistan (Reg# 092908)
GMP Status
prescribed format
years
146. Name and address of manufacture / Applicant M/s Faas Pharmaceuticals (Pvt.) Ltd.,
F-748/L, S.I.T.E Karachi, Pakistan
Contract Manufactured by: M/s
Pharmevo Private Limited. Plot # A-
29, North Western Industrial Zone,
Port Qasim, Karachi
Brand Name + Dosage Form and Strength Fasxime 100mg/5ml Powder for
Suspension
Composition Each reconstituted 5ml Contains:
Cefixime as
Trihydrate………….100mg
2018 Rs.50,000/- Dated 13-09-2018
Type of form Form 5
Pack size and Demand Price 30ml; As per SRO
Approval status of product in Reference Regulatory Cefixime 100mg/5ml Powder for
Me-too-status Mixo Dry Powder Suspension
100mg/5ml by M/s Maxitech Pharma
(Reg# 096373)
GMP Status “GMP certificate issued to M/s Faas
Pharmaceuticals (Pvt.) Ltd on 08-05-
2018”.
M/s Pharm Evo was visited by the
above panel on 7th Feb,2019.
Detailed report has been prepared on
prescribed format and is being
attached.
Keeping in view the people met,
documents observed and observations
made during the inspection, the panel
is of the view TO issue GMP
certificate to the Firm.
Remark of the Evaluator XI • Mention the correct weight of API in
master formulation considering the
hydrated form
• Submit contract manufacturing
agreement between M/s Faas
Pharmaceuticals and M/s
PharmEvo Pvt Ltd
Decision: Approved. Registration Board further decied that registration letter will be
issue dupon submission of following:
• Revised master formulation mentioning the correct weight of API considering the
hydrated form
• Contract manufacturing agreement between M/s Faas Pharmaceuticals and M/s
PharmEvo Pvt Ltd.
• Ffee of Rs. 75,000/- for correction/pre-approval change in master formulation
(correction/change of weight of API considering the hydrated form), as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
• Latest GMP inspection report for both M/s Faas Pharmaceuticals (Pvt.) Ltd and M/s
Pharmevo Private Limited from QA&LT Division, conducted within last three years
147. Name and address of manufacture / Applicant M/s Faas Pharmaceuticals (Pvt.) Ltd.,
F-748/L, S.I.T.E Karachi, Pakistan
Pharmevo Private Limited. Plot # A-
29, North Western Industrial Zone,
Port Qasim, Karachi
Brand Name + Dosage Form and Strength Feltrix 1g IV Dry Powder for
Injection
Ceftriaxone Sodium eq. to
Ceftriaxone………1000mg
2018 Rs.50,000/- Dated 13-09-2018
Type of form Form 5
Approval status of product in Reference Regulatory Rocephin 1g Powder for solution for
Authorities injection or infusion MHRA
Approved
Me-too-status Ceftro Injection 1gm IV by Curexa
Health, (Reg#82740)
GMP Status “GMP certificate issued to M/s Faas
Pharmaceuticals (Pvt.) Ltd on 08-05-
2018”.
M/s Pharm Evo was visited by the
above panel on 7th Feb,2019.
Detailed report has been prepared on
prescribed format and is being
attached.
Keeping in view the people met,
documents observed and observations
made during the inspection, the panel
is of the view TO issue GMP
certificate to the Firm.
Remark of the Evaluator XI • Submit contract manufacturing
agreement between M/s Faas
Pharmaceuticals and M/s
PharmEvo Pvt Ltd
approval letter.
• Firm has Sterile Dry Powder
Injectable (Cephalosporine) section
as per Secretary CLB letter No. F.
2-1/98-Lic (Vol-III) dated 10th
November 2022.
Decision: Approved. Registration Board further decied that registration letter will be
issue dupon submission of following:
• Contract manufacturing agreement between M/s Faas Pharmaceuticals and M/s
PharmEvo Pvt Ltd
• Latest GMP inspection report for both M/s Faas Pharmaceuticals (Pvt.) Ltd and M/s
Pharmevo Private Limited from QA&LT Division, conducted within last three years
148. Name and address of manufacture / Applicant M/s Linta Pharmaceuticals Pvt Ltd.,
Plot No. 03, Street No S-5, National
Industrial Zone, Rawat, Islamabad
Brand Name + Dosage Form and Strength Dom-C 15mg/20mg Tablets
Domperidone Maleate eq. to
Domperidone………15mg
Cinnarizine…………………….20mg
2018 Rs.20,000/- Dated 18-09-2018
Pharmacological Group Antiemetic & Antihistamine
Type of form Form 5
Finished product specifications Manufacturer specification
Pack size and Demand Price 1x10’s, 2x10’s, 5x10’s; As per SRO
Authorities
Me-too-status
2019 and conclusion of inspection
was:
Keeping in view the above it may be
concluded that M/s Linta
Pharmaceuticals is operating at
acceptable level of GMP standard.
• Provide evidence of applied
alongwith registration number,
brand name and name of firm.
149. Name and address of manufacture / Applicant M/s Farm Aid Group., Plot # 3/2,
Phase I & II, Hattar Industrial Estate,
Haripur
Brand Name + Dosage Form and Strength Panto-Aid 40mg Capsule
Composition Each hard gelatin capsule contains:
Pantoprazole Sodium EC pellets
22.5% w/w eq to
Pantoprazole…………………40mg
Source of pellets: Vision
Pharmaceuticals
2018 Rs.20,000/- Dated 13-06-2018
Pharmacological Group Proton pump inhibitors
Type of form Form 5
Authorities
Me-too-status Aprant 40mg Capsule by M/s
Adamjee Pharmaceuticals
(Reg#076139)
GMP Status
Remark of the Evaluator XI • Provide evidence of required
approval letter
• Valid GMP certificate of supplier of
pellets
150. Name and address of manufacture / Applicant M/s Gillman Pharmaceuticals., 41/2-
A, Phase I & II, Industrial Estate,
Hattar, Pakistan
Aulton Pharmaceuticals.
Plot No. 84/1, Block A, Phase V,
Industrial Estate, Hattar, K.P.K
Brand Name + Dosage Form and Strength Feromax 100mg/5ml Injection
Composition Each 5ml Amber Glass Ampoule
Contains:
Iron Sucrose eq. to Elemental
Iron………..100mg
2018 Rs.50,000/- Dated 07-12-2018
Pharmacological Group Anti-anaemic
Type of form Form 5
Approval status of product in Reference Regulatory Venofer (50mg/2.5mL, 100mg/5mL,
Authorities 200mg/10mL) (20mg/mL) in single-
dose vials. Injection USFDA
Approved
Me-too-status Irofit Injection 100mg/5ml by M/s
Zafa Pharma (Reg#82291)
GMP Status The firm M/s Aulton Pharmaceuticals
was inspected on 27-06-2019 and
As per observations made during
inspection, the manufacturing, quality
control and environmental facilities,
provided the qualified staff employed,
the documentation maintained,
implementation of the SOP’s the
GMP compliance status of the firm
M/s Aulton Pharma is found to be
satisfactory
Remark of the Evaluator XI • You have applied on form 5D while
mee too of the product is available.
Apply on prescribed form 5 for the
applied product
• Application must be submitted by
the applicant i.e. M/s Gillman
Pharmaceuticals.
missing
• You have not performed terminal
sterilization, justify
report of M/s Gillman
Pharmaceuticals conducted within
last three years
• Submit contract manufacturing
agreement between M/s M/s
Gillman Pharmaceuticals and M/s
M/s Aulton Pharmaceuticals
151. Name and address of manufacture / Applicant M/s Ferroza International
Pharmaceuticals Pvt. Ltd., 33 Km,
Ferozepur Road, Lahore
Brand Name + Dosage Form and Strength Fer-Antinal 5mg Tablet
Desloratadine…………5mg
2019 Rs.20,000/- dated 05-03-2019
Pharmacological Group Antihistamine
Type of form Form 5
Approval status of product in Reference Regulatory Clarinex 5mg film coated tablet
Authorities USFDA Approved.
Me-too-status Desatil Tablets 5mg by Aries
GMP Status
Remark of the Evaluator XI • Form 5 submitted without signature
by the applicant
missing
of applicable fee.
• Submit latest GMP inspection report
conducted within last three years
Desloratadine…………5mg
• Firm shall submit duly signed Form 5 submitted undertaking at the end of form 5
three years
Brand Name + Dosage Form and Strength Gemi-Fer 320mg Tablet
Gemifloxacin……………320mg
2019 Rs.20,000/- dated 05-03-2019
Pharmacological Group Fluoroquinolones
Type of form Form 5
Approval status of product in Reference Regulatory Disconitnued
Authorities
Me-too-status Gemibid 320mg Tablet by M/s
Evolution Pharmaceuticals
(Reg#095377)
GMP Status
by the applicant
missing
of applicable fee. Furthermore, you
have not mentioned the salt of
gemifloxacin in the label claim.
Mention the salt form of
gemifloxacin in label claim and
adjust its weight in master
formulation considering the salt
factor along with submission of
applicable fee.
Decision: Deferred for confirmation of regulatory status in reference regulatoty
authorities as the product is withdrawn from market in EMA
Brand Name + Dosage Form and Strength Lornofer 8mg Tablet
Lornoxicam…………8mg
2019 Rs.20,000/- dated 05-03-2019
Type of form Form 5
Approval status of product in Reference Regulatory Xefo 8mg film-coated tablet (EMA
Me-too-status Xonica 8mg Tablet by M/s Zephyr
Pharmatec (Reg#086983)
GMP Status
by the applicant
missing
of applicable fee.
• You have mentioned the addition of
5% overage in master formulation.
Provide scientific justification for
addition overage
Lornoxicam…………8mg
• Firm shall submit the fee of Rs. 30000/- for correction/pre-approval change in
tablet) and revision of master formulation without overages as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021.
three years
Brand Name + Dosage Form and Strength Sitafer-Met 50/1000 mg Tablet
Sitagliptin
Phosphate……………50mg
Metformin
HCl………………….1000mg
2019 Rs.20,000/- dated 05-03-2019
Pharmacological Group Antidiabetic
Type of form Form 5
Approval status of product in Reference Regulatory Janumet film coated tablet
Authorities (50mg/500mg, 50mg/1000mg)
USFDA Approved.
Me-too-status Sildomet M 50/1000mg Tablet by
M/s High-Q Pharmaceuticals
(Reg#76400)
GMP Status
Remark of the Evaluator XI • You have mentioned the label claim
without considering the salt factor in
case of sitagliptin. Revise the label
claim considering the salt factor
fee. Furthermore, mention the
hydrated form of sitagliptin in label
claim and adjust its weight in master
formulation considering the
hydrated form
• Mention the salt and hydrated form
of sitagliptin in master formulation
of applicable fee.
• Form 5 submitted without signature
by the applicant
missing
Sitagliptin as Phosphate monohydrate……………50mg
Metformin HCl………………….1000mg
in composition (correction/change of salt factor and hydrated form of the drug
substance) and revision of master formulation mentioning the salt and hydrated form of
sitagliptin, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
three years
Brand Name + Dosage Form and Strength Sitafer-Met 50/500 mg Tablet
Sitagliptin Phosphate……..…50mg
Metformin
HCl……………….500mg
2019 Rs.20,000/- dated 05-03-2019
Type of form Form 5
Approval status of product in Reference Regulatory Janumet film coated tablet
Authorities (50mg/500mg, 50mg/1000mg)
USFDA Approved.
Me-too-status Silomet M 50/500mg Tablet by M/s
High-Q Pharmaceuticals
(Reg#76399)
GMP Status
Remark of the Evaluator XI • You have mentioned the label claim
without considering the salt factor in
case of sitagliptin. Revise the label
claim considering the salt factor
fee. Furthermore, mention the
hydrated form of sitagliptin in label
claim and adjust its weight in master
formulation considering the
hydrated form
• Mention the salt and hydrated form
of sitagliptin in master formulation
of applicable fee.
by the applicant
missing
Sitagliptin as Phosphate monohydrate……………50mg
Metformin HCl………………….500mg
in composition (correction/change of salt factor and hydrated form of the drug
substance) and revision of master formulation mentioning the salt and hydrated form of
sitagliptin, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021
three years
Brand Name + Dosage Form and Strength Muscofer 4mg Capsule
Composition Each Capsule Contains:
Thiocolchicoside………4mg
2019 Rs.20,000/- dated 05-03-2019
Pharmacological Group Muscle Relaxants, Centrally Acting
Agents
Type of form Form 5
Approval status of product in Reference Regulatory MIOREL 4mg hard capsule, ANSM
Authorities France approved
Me-too-status Musrid 4mg Capsule by M/s Genix
Pharma (Reg#094856)
GMP Status
by the applicant
missing
• The firm have claimed for BP
specifications and the official
monograph is not available in any
pharmacopeia
three years
specifications as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form and Strength Feroflex-P 37.5/325 mg Tablet
Tramadol………………37.5mg
Paracetamol……………325mg
2019 Rs.20,000/- dated 05-03-2019
Pharmacological Group Opioids in combination with non-
opioid analgesics
Type of form Form 5
Approval status of product in Reference Regulatory Tramadol hydrochloride/Paracetamol
Authorities 37.5mg/325mg Film-coated Tablets
MHRA Approved
Me-too-status Distalgesic Tablets by M/s Atco Lab
(Reg#73865)
GMP Status
Remark of the Evaluator XI • You have not mentioned the salt
form of tramadol in label claim.
Revise the label claim mentioning
the salt form of tramadol along with
of applicable fee.
by the applicant
missing
Tramadol HCl………………37.5mg
Paracetamol……………325mg
three years
in composition (correction/change of salt form of the drug substance), as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
158. Name and address of manufacture / Applicant M/s Goodman Laboratories., No.5,
Street No. S-5, National Industrial
Zone, Rawat, Rawalpindi
Brand Name + Dosage Form and Strength Pine 100mg Tablet
Quetiapine as
Fumarate………….100mg
2019 Rs.20,000/- dated 04-03-2019
Pharmacological Group Antipsychotics
Type of form Form 5
Pack size and Demand Price 10’s, 14’s, 20’s, 30’s, 50’s; As per
SRO
Approval status of product in Reference Regulatory Quetiapine 100mg film coated tablet
Me-too-status Q-Med 100mg Tablets by M/s
Medera Pharmaceuticals,
(Reg#092163)
GMP Status GMP certificate issued to Goodman
Laboratories based on inspection
conducted on 08.08.2018
Remark of the Evaluator XI • Submit undertaking at the end of
form 5 duly signed by the technical
persons
• Submission of undertaking at the end of form 5 duly signed by the technical persons
Brand Name + Dosage Form and Strength Pine 25mg Tablet
Quetiapine as
Fumarate………….…25mg
2019 Rs.20,000/- dated 04-03-2019
Pharmacological Group Antipsychotics
Type of form Form 5
SRO
Approval status of product in Reference Regulatory Quetiapine 25mg film coated tablet
Me-too-status Q-Med 25mg Tablets by M/s Medera
Pharmaceuticals, (Reg#075431)
persons
Brand Name + Dosage Form and Strength Losap Plus Tablet 50/12.5mg
Losartan Potassium…………50mg
Hydrochlorothiazide………..12.5mg
2019 Rs.20,000/- dated 04-03-2019
Pharmacological Group Angiotensin II receptor blockers
(ARBs) and diuretics
Type of form Form 5
SRO
Approval status of product in Reference Regulatory Cozaar Comp 50mg/12.5mg film-
Authorities coated tablets MHRA approved
Me-too-status Losmart-H Tablet 50mg/ 12.5 mg by
M/s Scilife Pharma (Reg#100197)
persons
• You have mentioned the quantity of
losartan potassium in master
formulation (54.24mg/tab) more
than the label claim, clarify
• Submission of revised master formulation mentioning the quantity of API as per label
claim
Brand Name + Dosage Form and Strength Pride 200mg Tablet
Amisulpride……………..200mg
2019 Rs.20,000/- dated 04-03-2019
Pharmacological Group Antipsychotics (Benzamides)
Type of form Form 5
Pack size and Demand Price 10’s, 20’s, 30’s; As per SRO
Approval status of product in Reference Regulatory Amisulpride 200mg Tablets MHRA
Me-too-status Aurlex Tablets 200mg by M/s Bio-
mark Pharmaceuticals (Reg#093592)
persons
• You have not submitted
manufacturing outline for the
applied product. Submit complete
applied product
• Submission of complete manufacturing outline for the applied product
Brand Name + Dosage Form and Strength Pride 50mg Tablet
Amisulpride………….50mg
2019 Rs.20,000/- dated 04-03-2019
Pharmacological Group Antipsychotics (Benzamides)
Type of form Form 5
Approval status of product in Reference Regulatory Amisulpride 50mg Tablets MHRA
Me-too-status Aurlex Tablets 50mg by M/s Bio-
mark Pharmaceuticals (Reg#093591)
persons
applied product
Brand Name + Dosage Form and Strength E-Cit Tablet 5mg
Escitalopram as Oxalate……..5mg
2019 Rs.20,000/- dated 04-03-2019
Pharmacological Group Selective serotonin reuptake
inhibitors
Type of form Form 5
Pack size and Demand Price 10’s, 14’s, 20’s, 28’s, 30’s, 60’s; As
per SRO
Approval status of product in Reference Regulatory Lexapro (5mg, 10mg, 20mg) film-
Me-too-status Avulus 5mg Tablet by M/s Seatle
(Pvt) Ltd (Reg#098266)
persons
applied product
Brand Name + Dosage Form and Strength Dil Tablet 25mg
Carvedilol…………………25mg
2019 Rs.20,000/- dated 04-03-2019
Pharmacological Group Alpha and beta blocking agents
Type of form Form 5
Pack size and Demand Price 10’s, 20’s, 30’s, 50’s:As per SRO
Approval status of product in Reference Regulatory COREG (3.125mg, 6.25mg, 12.5mg,
Authorities 25mg) film-coated tablet USFDA
Approved
Me-too-status Vidocar 25mg Tablet by M/s Horizon
Healthcare (Reg#099537)
persons
applied product
165. Name and address of manufacture / Applicant M/s Hamaz Pharmaceuticals (Pvt.)
Ltd. 13-km, Bosan Road, Lutfabad,
Multan
Brand Name + Dosage Form and Strength Cpine Injection 250mg
Composition Each Vial Contains
Cefepime as HCl with L Arginine eq.
to Cefepime.…250mg
2019 Rs.20,000/- dated 05-03-2019
Pharmacological Group Fourth-generation cephalosporins
Type of form Form 5
Authorities
Me-too-status Cefstar Injection IV/IM 250mg by
M/s Barrett Hodgson Pakistan
(Reg#076005)
2018 and recommendations of
inspection were:
In view of all the above it is observed
that the management has addressed
most of the short comings, which were
pointed out during the last inspection
which leads the panel of inspectors to
the conclusions that the firm is
presently operating at satisfactory
level of GMP compliance of M/s
Hamaz Pharmaceuticals is situated at
Multan hence it is advised to the
management to continue their efforts
to further upgrade their systems.
• The firm have mentioned different
names and dosage form on cover
letter, form 5 and fee challan. The
name mentioned on cover letter
Cefnir suspension 125mg/5ml, fee
challan is Cefnir /
Cefdinir125mg/5ml while name
mentioned on form 5 is Cpine
injection 250mg, clarify? You have
also not mentioned the dosage form
on fee challan
approval letter
3% overage in master formuation,
provide scientific justification for
addition of overage
• The firm have mentioned the use of
type II glass vial as primary
packaging material of the applied
formulation
Multan
Brand Name + Dosage Form and Strength Ketorol Injection 30mg/ml
Ketorolac Tromethamine…30mg
2019 Rs.20,000/- dated 05-03-2019
Type of form Form 5
Pack size and Demand Price 1mlx5’s; As per SRO
Approval status of product in Reference Regulatory TORADOL Injection (15mg/ml,
Authorities 30mg/ml) USFDA approved.
or efficacy reasons**
Me-too-status Xevolac 30mg/ml Injection by M/s
Danas Pharmaceuticals
(Reg#099867)
inspection were:
• The firm have mentioned different
names, molecule and dosage form on
cover letter, form 5 and fee challan.
The name mentioned on cover letter
is Fosimax suspension 250mg/5ml,
fee challan is Fosimax / Fosfomycin
calcium dry suspension while name
mentioned on form 5 is Ketorol
injection 30mg/ml
(ketorolactromethamine), clarify?
Furthermore, the above mentioned
product on form 5 is already
applied, clarify why you applied the
same product again.
• You have not mentioned terminal
sterilization in manufacturing
outline, justify?
• Mention type of primary packaging
material of applied formulation
whether it is type I, II or III
approval letter
5% overage of API in master
formulation, clarify?
• You have mentioned Ketorolac
trometamol in master formulation
while Ketorolac trometamine in
label calim, clarify?
outline of the applied product
• Same molecule and dosage form
already considered by the
Registration board in 321st DRB
meeting
Decision: Registration Board decided to reject the application as same molecule and
dosage form has already been considered by the Registration board in 321st meeting
Multan
Brand Name + Dosage Form and Strength Trama Injection 100mg/2ml
Tramadol HCl………100mg
2019 Rs.20,000/- dated 05-03-2019
Pharmacological Group Opioids Analgesic
Type of form Form 5
Pack size and Demand Price 2mlx5’s; As per SRO
Approval status of product in Reference Regulatory TRAMAL tramadol hydrochloride
Authorities 100mg/2mL injection ampoule TGA
Approved
Me-too-status Amadrol Injection 100mg/ 2ml by
M/s Amarant Pharmacetuicals
(Reg#83042)
inspection were:
Remark of the Evaluator XI • The firm have mentioned different
names, molecule and dosage form on
cover letter, form 5 and fee challan.
The name mentioned on cover letter
is Cefnir suspension 250mg/5ml, fee
challan is Cefnir / cefdinir
250mg/5ml while name mentioned
on form 5 is Trama injection
100mg/2ml (Tramadol
Hydrochloride), clarify?
Furthermore, the above mentioned
product on form 5 is already
applied, clarify why you applied the
same product again.
• You have mentioned the weight of
Tramadol HCl 105mg/2m in master
formulation instead of 100mg/2ml as
per label claim, clarify?
• You have not mentioned terminal
sterilization in manufacturing
outline, justify?
approval letter
outline of the applied product
• Same molecule and dosage form
already approved by the
Registration board in 321st DRB
meeting
Decision: Registration Board decided to reject the application as same molecule and
dosage form has already been approved by the Registration board in 321st meeting
168. Name and address of manufacture / Applicant M/s Hudson Pharma Private Limited.,
Site-Plot No. D-93, North Western
Industrial Zone, Port Qasim
Authority, Pakistan
Brand Name + Dosage Form and Strength Vilavent 100mcg/25mcg Rotacaps
Composition Each Rotacaps Contains:
Fluticasone furoate………….100mcg
Vilanterol as
Trifenatate…………...25mcg
2019 Rs.20,000/- dated 05-03-2019
corticosteroids or other drugs, excl.
anticholinergics
Type of form Form 5
Approval status of product in Reference Regulatory BREO ELLIPTA (100/25mcg,
Authorities 200/25mcg, inhalation powder)
USFDA approved
Me-too-status Relvar Ellipta Dry Powder Inhaler
100mcg/25mcg by M/s Glaxo Smith
Kline Pakistan (Reg# 085722)
was:
Overall cGMP is found at acceptable
level and the management is
committed for continual improvement
and has assured further cGMP
compliance.
Registration Board:
Delivery Dose”.
• Submitted undertaking at the of
form 5 submitted with stamped
signature
approval letter
• Submit stability studies data of three
batches as per the guidelines
approved in 293rd meeting of
Registration Board
169. Name and address of manufacture / Applicant M/s Hudson Pharma Private Limited.,
Site-Plot No. D-93, North Western
Industrial Zone, Port Qasim
Authority, Pakistan
Brand Name + Dosage Form and Strength Vilavent 200mcg/25mcg Rotacaps
Composition Each Rotacaps Contains:
Fluticasone
furoate……….……200mcg
Vilanterol as
Trifenatate……….25mcg
2019 Rs.20,000/- dated 05-03-2019
corticosteroids or other drugs, excl.
anticholinergics
Type of form Form 5
Approval status of product in Reference Regulatory BREO ELLIPTA (100/25mcg,
Authorities 200/25mcg, inhalation powder)
USFDA approved
Me-too-status Relvar Ellipta Dry Powder Inhaler
200mcg/25mcg by M/s Glaxo Smith
Kline Pakistan (Reg# 085723)
was:
Overall cGMP is found at acceptable
level and the management is
committed for continual improvement
and has assured further cGMP
compliance.
XI
Registration Board:
Delivery Dose”.
• Submitted undertaking at the of
form 5 submitted with stamped
signature
approval letter
• Submit stability studies data of three
Registration Board
170. Name and address of manufacture / Applicant M/s ISIS Pharmaceuticals &
Chemical Works., 25/1-3, Sector 12-
C, North Karachi Industrial Area,
Karachi
Brand Name + Dosage Form and Strength Istisone Cream 1% w/w
Composition Contains:
Hydrocortisone……….…1% w/w
2019 Rs.20,000/- dated 05-03-2019
Type of form Form 5
Pack size and Demand Price 10gm; As per SRO
Approval status of product in Reference Regulatory Hydrocortisone Cream BP 1.0%
Authorities MHRA approved
Me-too-status Corteroid Cream by M/s FYNK
GMP Status
Remark of the Evaluator XI • Revise 1st page of form 5 as per
prescribed format duly signed by the
applicant
• The applied label claim is not as per
reference product. Revise the label
claim as per reference product
along with submission of
applicable fee.
Each gram Contains:
Hydrocortisone……….…1% w/w
• Firm shall submit the fee of Rs. 7,500/- for correction/pre-approval change in label claim
in form 5 as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
three years
• Firm shall submit 1st page of form 5 as per prescribed format duly signed by the
applicant
Karachi
Brand Name + Dosage Form and Strength Isfyl Cough Syrup 45mg/8mg
Acefylline Piperazine…………45mg
Diphenhydramine HCl………..8mg
2019 Rs.20,000/- dated 05-03-2019
Pharmacological Group Xanthine/ Anti-histamine
Type of form Form 5
Pack size and Demand Price 60ml, 120ml, 450ml; As per SRO
Authorities
Me-too-status Acelyf Syrup by M/s Hicon
GMP Status
rescribed format duly signed by the
applicant
Karachi
Brand Name + Dosage Form and Strength Iszyl Tablet 300mg
Allopurinol…………300mg
2019 Rs.20,000/- dated 05-03-2019
Pharmacological Group Antigout Preparations
Type of form Form 5
Approval status of product in Reference Regulatory ZYLOPRIM (100mg, 300mg) tablets
Authorities USFDA approved
Me-too-status Parinol 300mg Tablet by M/s Pulse
GMP Status
applicant
Decision: Approved.
three years
• Firm shall submit 1st page of form 5 as per prescribed format before issuance of
registration letter along with applicable fee for revision of Form 5, as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Karachi
Brand Name + Dosage Form and Strength Isget Tablet 10mg
Atorvastatin as Atorvastatin Calcium
trihydrate…..…10mg
2019 Rs.20,000/- dated 05-03-2019
Type of form Form 5
Pharma (Reg#098542)
GMP Status
applicant
• Renewal of DML granted on 15-06-
2021
st
Karachi
Brand Name + Dosage Form and Strength Issacic Tablet 500mg
Basic Aluminium Sucrose Sulfate
(Sucralfate)……500mg
2019 Rs.20,000/- dated 05-03-2019
Pharmacological Group Other drugs for peptic ulcer and
gastro-oesophageal reflux disease
(GORD)
Type of form Form 5
Authorities
Me-too-status Acenil Tablet 500mg by M/s
Medisave Pharmaceuticals
(Reg#068189)
GMP Status
applicant
2021
Karachi
Brand Name + Dosage Form and Strength Is-Ferate Syrup
Ferrous sulphate…………200mg
2019 Rs.20,000/- dated 05-03-2019
Pharmacological Group Iron bivalent, oral preparations
Type of form Form 5
Authorities
Me-too-status Ferrous Sulphate Syp by M/s
Hameedsons F Abad
(Reg#004676)…strength per ml
GMP Status
applicant
2021
Karachi
Brand Name + Dosage Form and Strength Isphage Tablet 500mg
Metformin HCl……….…500mg
2019 Rs.20,000/- dated 05-03-2019
Pharmacological Group Biguanide (Antidiabetic)
Type of form Form 5
Approval status of product in Reference Regulatory Metformin Hydrochloride 500mg
Authorities film coated Tablets MHRA
Approved
Me-too-status Glucomin 500mg Tablet by M/s
Lisko Pakistan (Reg#082146)
GMP Status
applicant
2021
st
Karachi
Brand Name + Dosage Form and Strength Istamazole Tablet 400/500mg
Metronidazole…………400mg
Diloxanide Furoate…….500mg
2019 Rs.20,000/- dated 05-03-2019
Pharmacological Group Nitroimidazole derivatives
Type of form Form 5
Authorities
Me-too-status Disenite Tablets by M/s Hizat
Pharmaceutical Industry
(Reg#078409)
GMP Status
applicant
2021
Karachi
Brand Name + Dosage Form and Strength Iszinc Oral Suspension 20mg/5ml
Zinc Sulphate Monohydrate eq. to
elemental zinc ……20mg
2019 Rs.20,000/- dated 05-03-2019
Pharmacological Group Other Mineral Supplements
Type of form Form 5
Finished product specifications Manufacturer’s specifictations
Pack size and Demand Price 30ml, 60ml; As per SRO
Authorities
Me-too-status Zincor 200mg Dry Susp by M/s
Genome Pharmaceuticals
(Reg#075533)
GMP Status
applicant
2021.
• Applied formulation is dry powder
suspension
Karachi
Brand Name + Dosage Form and Strength Iszinc Syrup 20mg/5ml
Zinc Sulphate Monohydrate eq. to
elemental zinc..…20mg
2019 Rs.20,000/- dated 05-03-2019
Pharmacological Group Other Mineral Supplements
Type of form Form 5
Pack size and Demand Price 60ml, 120ml, 450ml; As per SRO
Approval status of product in Reference Regulatory Available in IP of WHO as solution
Authorities (Available strengths: 10mg & 20mg
of zinc per 5 mL)
Me-too-status ZNC 20mg/5ml Syrup by M/s Rotex
Pharma (Reg#099950)
GMP Status
applicant
2021
180. Name and address of manufacture / Applicant M/s Nabiqasim Industries Pvt Ltd.
17/24, Korangi Industrial Area,
Karachi, Pakistan
Brand Name + Dosage Form and Strength Glitab Tablet 5mg/500mg
Dapagliflozin Popanediol
Monohydrate eq to
Dapagliflozins……………..5mg
Metformin HCl…………….500mg
2019 Rs.20,000/- dated 05-03-2019
Pharmacological Group Combinations of oral blood glucose
lowering drugs
Type of form Form 5
Approval status of product in Reference Regulatory XIGDUO XR (2.5mg/1000mg,
Authorities 5mg/500mg, 5mg/1000mg,
10mg/500mg, 10mg/1000mg)
USFDA Approved
Me-too-status
was:
findings of the inspection M/s Nabi
Qasim Karachi is considered to be
operating at an acceptable level of
compliance of GMP requirements.
Remark of the Evaluator XI • Provide evidence of applied
along with registration number,
brand name and name of firm OR
submit application on requisite
form 5D, stability studies data of
three batches as per the guidelines
Registration Board, along with
submission of differential fee.
coated extended release tablets and
contain immediate release
dapagliflozine and extended
release metformin hydrochloride
drug substance. Revise your
formulation and manufacturing
outline as per reference
of applicable fee.
Decision: Deferred for evaluation of stability study data on its turn
181. Name and address of manufacturer / Applicant M/s Radiant Pharma Pvt Ltd., 43-E,
Sundar Industrial Estate, Lahore
Brand Name + Dosage Form and Strength Empozin 25mg Tablet
Empagliflozin…………25mg
Dairy No. date of R &I fee Form-5D Dy.No 11222 dated 05-03-
2019 Rs.50,000/- dated 05-03-2019
Excl. Insulins
Pack size and Demand Price 7x1’s, 10x1’s, 14x1’s, 28x1’s, 30x1’s,
60x1’s, 70x1’s, 90x1’s, 100x1’s; As
per SRO
GMP Status
Remark of the Evaluator XI • You have applied on form 5D.
applied product
• Submit stability study data of three
Registration Board.
Brand Name + Dosage Form and Strength Empozin 10mg Tablet
Empagliflozin……………10mg
2019 Rs.50,000/- dated 05-03-2019
Excl. Insulins
Pack size and Demand Price 7x1’s, 10x1’s, 14x1’s, 28x1’s, 30x1’s,
60x1’s, 70x1’s, 90x1’s, 100x1’s; As
per SRO
GMP Status
Remark of the Evaluator XI • You have applied on form 5D.
applied product
Registration Board.
Brand Name + Dosage Form and Strength Recoxia 90mg Tablet
Etoricoxib………………90mg
2019 Rs.50,000/- dated 05-03-2019
Pack size and Demand Price 2’s, 5’s, 7’s, 10’s, 14’s, 20’s, 28’s,
30’s, 50’s, 84’s, 100’s; As per SRO
Approval status of product in Reference Regulatory ARCOXIA 90mg film coated tablet
Me-too-status
GMP Status
Remark of the Evaluator XI • Submit stability study data of three
Registration Board.
Brand Name + Dosage Form and Strength Recoxia 120mg Tablet
Etoricoxib…………….120mg
2019 Rs.50,000/- dated 05-03-2019
Pack size and Demand Price 2’s, 5’s, 7’s, 10’s, 14’s, 20’s, 28’s,
30’s, 50’s, 84’s, 100’s; As per SRO
Approval status of product in Reference Regulatory ARCOXIA 120mg film coated tablet
Me-too-status
GMP Status
Registration Board.
Brand Name + Dosage Form and Strength Zolaxen Tablets
375mg enteric coated Naproxen
20mg immediate release
Esomeprazole magnesium
2019 Rs.50,000/- dated 05-03-2019
Pharmacological Group NSAID and PPI combination
SRO
Approval status of product in Reference Regulatory VIMOVO (naproxen and
Authorities esomeprazole magnesium trihydrate)
delayed-release tablets, for oral use
(375 mg enteric-coated naproxen /20
mg immediate-release esomeprazole
film-coated or 500 mg enteric-coated
naproxen /20 mg immediate-release
esomeprazole film-coated). US-FDA
approved
Me-too-status
GMP Status
Remark of the Evaluator XI • Mention hydrated form of
esomeprazole in label claim. Revise
applicable fee, and adjust the weight
of API in Master formula
considering the salt and hydrated
form.
• The reference formulation is
delayed release tablet while you
have applied otherwise. Revise label
as per reference formulation along
with submission of applicable fee
• The submitted manufacturing
outline is not as per reference
product. Submit manufacturing
outline as per reference product
accordingly
Registration Board.
Brand Name + Dosage Form and Strength Zolaxen plus Tablets
500mg enteric coated Naproxen
20mg immediate release
2019 Rs.50,000/- dated 05-03-2019
Pharmacological Group NSAID and PPI combination
SRO
Approval status of product in Reference Regulatory VIMOVO (naproxen and
Authorities esomeprazole magnesium trihydrate)
delayed-release tablets, for oral use
(375 mg enteric-coated naproxen /20
mg immediate-release esomeprazole
film-coated or 500 mg enteric-coated
naproxen /20 mg immediate-release
esomeprazole film-coated). US-FDA
approved
Me-too-status
GMP Status
Remark of the Evaluator XI • Mention hydrated form of
esomeprazole in label claim. Revise
applicable fee, and adjust the weight
of API in Master formula
considering the salt and hydrated
form.
• The reference formulation is
delayed release tablet while you
have applied otherwise. Revise label
as per reference formulation along
with submission of applicable fee
• The submitted manufacturing
outline is not as per reference
product. Submit manufacturing
outline as per reference product
accordingly
Registration Board.
Brand Name + Dosage Form and Strength Lesart 10/40mg Tablet
Telmisartan……………………40mg
Amlodipine as Besylate………10mg
2019 Rs.20,000/- dated 05-03-2019
Pharmacological Group Calcium channel blockers and
Angiotensin II receptor blockers
(ARBs)
Type of form Form 5
Approval status of product in Reference Regulatory TWYNSTA (40/5mg, 40/10mg,
Authorities 80/5mg, 80/10mg) Tablets USFDA
Approved
Me-too-status Cresar AM Tablet 10mg/40mg by M/s
Tabros Pharma (Reg#094851)
GMP Status
Remark of the Evaluator XI • You have applied for film coated
formulation is bilayered tablets.
Revise your label claim, formulation
• Provide evidence of availability of
bilayered compression tablet facility
shortcomings within six months of issuance of minutes of 322nd meeting. In case
Pharmaceutical Evaluation Cell does not receive any response from firm within the given
time, the case will be placed before Registration Board for decision.
Telmisartan…………………..80mg
Amlodipine as Besylate.……..10mg
2019 Rs.20,000/- dated 05-03-2019
(ARBs)
Type of form Form 5
Approved
GMP Status
Telmisartan……………………40mg
Amlodipine as Besylate……….5mg
2019 Rs.20,000/- dated 05-03-2019
(ARBs)
Type of form Form 5
Approved
GMP Status
Telmisartan…………………...80mg
Amlodipine as Besylate….…..5mg
2019 Rs.20,000/- dated 05-03-2019
(ARBs)
Type of form Form 5
Approved
GMP Status
Brand Name + Dosage Form and Strength Rovan Tablet 15mg
Tolvaptan………..15mg
2019 Rs.50,000/- dated 05-03-2019
Pharmacological Group Vasopressin antagonists
Pack size and Demand Price 10, 30, 90, blister, or 500 count
bottle; As per SRO
Approval status of product in Reference Regulatory JYNARQUE (15mg, 30mg, 45mg,
Authorities 60mg, 90mg) tablets USFDA
approved
Me-too-status
GMP Status
Registration Board.
shortcomings along with stability studies data as per checklist of 293rd meeting of RB, in
light of the Notifdication No. 320-DRB/ 2022(PE&R) dated 17th October 2022.
Brand Name + Dosage Form and Strength Rovan Tablet 30mg
Tolvaptan………...30mg
2019 Rs.50,000/- dated 05-03-2019
Pharmacological Group Vasopressin antagonists
Pack size and Demand Price 10, 30, 90, blister, or 500 count
bottle; As per SRO
Approval status of product in Reference Regulatory JYNARQUE (15mg, 30mg, 45mg,
Authorities 60mg, 90mg) tablets USFDA
approved
Me-too-status
GMP Status
Registration Board.
shortcomings along with stability studies data as per checklist of 293rd meeting of RB, in
light of the Notifdication No. 320-DRB/ 2022(PE&R) dated 17th October 2022.
Brand Name + Dosage Form and Strength Belock Tablet 80mg/5mg
Valsartan……………………80mg
Amlodipine as Besylate…….5mg
2019 Rs.20,000/- dated 05-03-2019
(ARBs)
Type of form Form-5
Pack size and Demand Price ; As per SRO
Approval status of product in Reference Regulatory Amlodipine/Valsartan 5mg/80mg
Authorities film-coated tablets MHRA Approved
Me-too-status Amlodine Tablet 5/80 by M/s Jupiter
Pharma (Reg#081931)
GMP Status
tablets but the master formulation
does not show coating composition
and manufacturing outline does not
show coating procedure, clarify and
revise your master formulation and
Decision: Approved.
• Firm shall submit revised master formulation and manufacturing outline mentioning
coating composition and coating procedure respectively.
three years
• Firm shall submit fee of Rs.7,500/- for correction/pre-approval change in the amster
formulation and method of manufacture, as per notification No.F.7-11/2012-
Case No. 08: Registration applications of Human Drugs on Form 5F (Local) whose reply is not
received
194. Name, address of Applicant / Marketing Kaizen Pharmaceuticals (Pvt.) Ltd., E-127-129,
Authorization Holder North Western Industrial Zone, Bin Qasim,
Karachi-75020, Pakistan.
Name, address of Manufacturing site. Kaizen Pharmaceuticals (Pvt.) Ltd., E-127-129,
North Western Industrial Zone, Bin Qasim,
☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand Ilazo 10mg tablet
name
Strength / concentration of drug of Each film coated tablet contains
Active Pharmaceutical ingredient (API) Vilazodone HCl…………...10mg
per unit
Pharmacotherapeutic Group of (API) Angiotensin II receptor blocker
Manufacturer’s specification
specifications
Proposed Pack size 10’s, 20’s, 30’s
The status in reference regulatory VIIBRYD (10mg, 20mg, 40mg) film-coated
authorities tablets USFDA Approved
GMP status of the Finished product The firm was inspected on 11-08-2020 and
manufacturer conclusion of inspection was:
The overall cGMP compliance of the firm with
respect to building, facilities and procedures
demonstrated was satisfactory at the time of
inspection.
Name and address of API manufacturer. Section 1.6.5: M/s Symed Labs Limited
Sy.No.744, 745, 750, 751, 752 & 751.
Mandollagudem Village, Choutuppal Mandal,
Yadadri District, Telangana India. (expired 24-
04-2018)
3.2.S.2: Symed Labs Limited (Unit-I) Survey
No.353, Domadugu (Village), Jinnaram
(Mandal), Medak (Dist) – 502 313. Telangana,
India.
procedures and its verification, batch analysis and
drug substance and drug product is submitted.
manufacturing process and controls, tests for
impurity, specifications, analytical procedures
drug substance
months
months
Batches:(VLH Ex No: 001, VLH Ex No: 002,
VLH Ex No: 003)
procedure (including dissolution testing at acidic
and buffer medium) and its verification studies,
comparative dissolution profile established against the brand that is Viibryd 10mg
tablet performing quality tests (Identification,
Assay, Dissolution).
CDP has been performed against the same brand
that is Viibryd 10mg Tablet in Acid media (pH
0.1N HCl), Acetate Buffer (pH 4.5) & Phosphate
Buffer (pH 6.8). The values for f2 are in the
acceptable range.
Analytical method Method validation studies have submitted
validation/verification of product including linearity, accuracy, precision,
specificity, LOD, LOQ)
Manufacturer of API Symed Labs Limited (Unit I), Survey No.353, Domadugu (Village),
Jinnaram (Mandal), Medak (Dist.) - 502 313. Telangana, India
(Applied)
API Lot No. VLH0060616
Description of Pack
PVC/ aluminum blister pack
Real Time: 0, 3, 6, 9, 12, 18, 24(Months)
Batch No. TF-01 TF-02 TF-03
No. of Batches 03
1. Reference of previous approval of The firm has submitted reference of previous
applications with stability study data of inspection report of Rofair 500 mcg Tablet which
the firm (if any) is conducted on 25-06-2019 and considered in
290th meeting of Registration Board. The report
confirms that:
• HPLC system is 21 CFR part II compliant and
Audit trail reports were available
• Firm has adequate monitoring and controls for
stability chambers. Chambers are controlled and
monitored through software having alarm
system for alerts as well
2. Approval of API/ DML/GMP certificate The firm submitted certificate No.
of API manufacturer issued by concerned L.Dis.No.6592/A3/2017 of M/s Symed Labs
regulatory authority of country of origin. Limited Sy.No.744, 745 & 751. Mandollagudem
Village, Choutuppal Mandal, Yadadri District,
Telangana India issued by Drugs Control
Administration Govt. of Telangana. (valid upto
24-04-2018)
3. Documents for the procurement of API Firm has submitted FedEx receipt dated 28-
with approval from DRAP (in case of March-2017. However, the contents of receipt are
import). not readable
4. Data of stability batches will be Firm has submitted data of stability batches along
supported by attested respective with attested respective documents like
documents like chromatograms, Raw chromatograms, Raw data sheets, summary data
data sheets, COA, summary data sheets sheets etc.
etc.
testing
6. Record of Digital data logger for Firm has submitted record of Digital data logger
temperature and humidity monitoring of for temperature and humidity monitoring of
stability chambers (real time and stability chambers (real time and accelerated)
accelerated)
1.5.5. • Mention correct Pharmacological class of the API
(drug substance) along with WHO ATC code for
each distinct therapeutic indication.
1.6.5 • Valid GMP certificate / DML of drug substance
manufacturer issued by relevant regulatory
authority of country of origin is required
• Clarification shall be submitted since the
submitted GMP, COA, stability summary sheet of
drug substance and section 3.2.S.2.1 of form 5F
reflects different manufacturing site
3.2.S.4 • Analytical Method Verification studies including
specificity, accuracy and repeatability (method
precision) performed by the Drug Product
manufacturer for drug substance(s) shall be
submitted.
3.2.S.6 • Description of the container closure system(s) for
the shipment and storage of the API including
materials of construction of each primary
packaging component.
3.2.P.2.2.1 • A brief description of formulation development
shall be given.
3.2.P.5.1. • Justify the acceptance criteria of dissolution test
NLT Q in 45min in product specifications since
FDA review documents specifies that dissolution
criteria shall be NLT Q in 30 min for the applied
product
3.2.P.5.3 • No chromatographic conditions are mentioned in
3.2.P.5.4 • Identification test as mentioned in specification is
by HPLC while in Batch analysis performed by IR,
clarify?
3.2.P.6 • COA of Reference Standards or Materials is not
submitted, instead COA of Drug substance is
submitted. COA of primary / secondary reference
standard including source and lot number shall be
provided.
3.2.P.8 • The quantity of imported drug substance as per
submitted COA is 40gm (DS COA) / 0.039KG
(Drug product COA) and three batches of 10mg &
20mg Ilazo tablets each of 1500 tablets were
manufactured from it. Justification is required as
how the imported drug substance was sufficient
enough to manufacture three batches of each
strength. (drug substance required for three
batches of 10mg tab 45.33 gm and 20mg tab is
90.54gm)
• COAs of performed stability study are not
submitted
• Compliance Record of HPLC software 21CFR &
audit trail reports on product testing is not
submitted
• Submit readable copy of documents for the
procurement of API with approval from DRAP.
• Sampling and testing date of API by drug product
manufacturer is 13-11-2017 while manufacturing
date of the drug product batch No. TF-01 is 13-09-
2017 which is prior to sampling and testing date of
API, clarify?
195. Name, address of Applicant / Kaizen Pharmaceuticals (Pvt.) Ltd., E-127-129,
Marketing Authorization Holder North Western Industrial Zone, Bin Qasim,
Name, address of Manufacturing site. Kaizen Pharmaceuticals (Pvt.) Ltd., E-127-129,
North Western Industrial Zone, Bin Qasim,
☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand Ilazo 20mg tablet
name
Strength / concentration of drug of Each film coated tablet contains
Active Pharmaceutical ingredient Vilazodone HCl…………...20mg
(API) per unit
Pharmacotherapeutic Group of (API) Antidepressant Agent
Reference to Finished product Manufacturer’s specification
specifications
Proposed Pack size 10’s, 20’s, 30’s
The status in reference regulatory VIIBRYD (10mg, 20mg, 40mg) film-coated
GMP status of the Finished product The firm was inspected on 11-08-2020 and
manufacturer conclusion of inspection was:
The overall cGMP compliance of the firm with
respect to building, facilities and procedures
demonstrated was satisfactory at the time of
inspection.
Name and address of API manufacturer. Section 1.6.5: M/s Symed Labs Limited
Sy.No.744, 745, 750, 751, 752 & 751.
Mandollagudem Village, Choutuppal Mandal,
Yadadri District, Telangana India. (expired 24-
04-2018)
3.2.S.2: Symed Labs Limited (Unit-I) Survey
No.353, Domadugu (Village), Jinnaram
(Mandal), Medak (Dist) – 502 313. Telangana,
India.
impurity, specifications, analytical procedures
drug substance
months
months
Batches:(VLH Ex No: 001, VLH Ex No: 002,
VLH Ex No: 003)
comparative dissolution profile established against the brand that is Viibryd 20mg
tablet performing quality tests (Identification,
Assay, Dissolution).
that is Viibryd 20mg Tablet in Acid media (pH
0.1N HCl), Acetate Buffer (pH 4.5) & Phosphate
acceptable range.
specificity, LOD, LOQ)
Manufacturer of API Symed Labs Limited (Unit I), Survey No.353, Domadugu (Village),
Jinnaram (Mandal), Medak (Dist.) - 502 313. Telangana, India
(Applied)
API Lot No. VLH0060616
Description of Pack PVC/ aluminum blister pack
Real Time: 0, 3, 6, 9, 12, 18, 24(Months)
No. of Batches 03
applications with stability study data of inspection report of Rofair 500 mcg Tablet which
the firm (if any) is conducted on 25-06-2019 and considered in
290th meeting of Registration Board. The report
confirms that:
• HPLC system is 21 CFR part II compliant and
Audit trail reports were available
• Firm has adequate monitoring and controls for
stability chambers. Chambers are controlled and
monitored through software having alarm
system for alerts as well
2. Approval of API/ DML/GMP certificate The firm submitted certificate No.
of API manufacturer issued by L.Dis.No.6592/A3/2017 of M/s Symed Labs
concerned regulatory authority of Limited Sy.No.744, 745 & 751. Mandollagudem
country of origin. Village, Choutuppal Mandal, Yadadri District,
Telangana India issued by Drugs Control
Administration Govt. of Telangana. (valid upto
24-04-2018)
3. Documents for the procurement of API Firm has submitted FedEx receipt dated 28-
with approval from DRAP (in case of March-2017. However, the contents of receipt are
import). not readable
4. Data of stability batches will be Firm has submitted data of stability batches along
supported by attested respective with attested respective documents like
documents like chromatograms, Raw chromatograms, Raw data sheets, summary data
data sheets, COA, summary data sheets sheets etc.
etc.
testing
6. Record of Digital data logger for Firm has submitted record of Digital data logger
temperature and humidity monitoring of for temperature and humidity monitoring of
stability chambers (real time and stability chambers (real time and accelerated)
accelerated)
manufacturer issued by relevant regulatory authority
of country of origin is required
• Clarification shall be submitted since the submitted
GMP, COA, stability summary sheet of drug
substance and section 1.6.5 and section 3.2.S.2.1 of
form 5F reflects different manufacturing site
3.2.S.4 • Analytical Method Verification studies including
submitted.
3.2.S.6 • Description of the container closure system(s) for
the shipment and storage of the API including
materials of construction of each primary packaging
component.
3.2.P.2.2.1 • A brief description of formulation development shall
be given.
3.2.P.5.1. • Justify the acceptance criteria of dissolution test
NLT Q in 45min in product specifications since FDA
review documents specifies that dissolution criteria
shall be NLT Q in 30 min for the applied product
3.2.P.5.3 • No chromatographic conditions are mentioned in
3.2.P.6 • COA of primary / secondary reference standard
including source and lot number shall be provided.
3.2.P.8 • The quantity of imported drug substance as per
submitted COA is 40gm (DS COA) / 0.039KG (Drug
product COA) and three batches of 10mg & 20mg
Ilazo tablets each of 1500 tablets were manufactured
from it. Justification is required as how the imported
drug substance was sufficient enough to manufacture
three batches of each strength. (drug substance
required for three batches of 10mg tab 45.33 gm and
20mg tab is 90.54gm)
• COAs of performed stability study are not submitted
• Compliance Record of HPLC software 21CFR &
audit trail reports on product testing is not submitted
• Submit readable copy of documents for the
procurement of API with approval from DRAP.
• Sampling and testing date of API by drug product
manufacturer is 13-11-2017 while manufacturing
date of the drug product batch No. TF-01 is 13-09-
2017 which is prior to sampling and testing date of
API, clarify?
196. Name, address of Applicant / Marketing M/s Global Pharmaceuticals (Pvt.) Ltd. Plot # 204-
Authorization Holder 205 Industrial Triangle, kahuta Road, Islamabad,
Pakistan
Name, address of Manufacturing site. M/s Global Pharmaceuticals (Pvt.) Ltd. Plot # 204-
205 Industrial Triangle, kahuta Road, Islamabad,
Pakistan
☐ Importer
☐ Export sale
The proposed proprietary name / brand Deglu-Met 5mg/850mg Tablet
name
Pharmaceutical ingredient (API) per unit Dapagliflozin…….5mg
Metformin HCL….850mg
Pharmaceutical form of applied drug Tablet
Pharmacotherapeutic Group of (API) sodium-glucose co-transporter 2 (SGLT2)
inhibitors.
biguanide class of antidiabetics
Innovator specs
specifications
The status in reference regulatory XIGDUO 5mg/850mg Tablet. (Health Canada
authorities approved)
For generic drugs (me-too status) Dapa-Met 5mg/850mg Tablet by M/s Hilton Pharma
(Reg# 093071)
GMP status of the Finished product GMP certificate issued on 24-12-2018 based on
manufacturer inspection conducted on 24-10-2018.
Name and address of API manufacturer. Dapagliflozin: Fuxin Long Rui Pharmaceutical Co.
Ltd., Fluoride Industrial park, Fuxin city, Liaoning
province, 123000, China.
Metformin HCL: Aarti Drugs Limited., Plot No.
211 - 213, Road No.2 G.I.D.C., Sarigam, Dist.:
Valsad, Gujarat. INDIA.396155
Module III (Drug Substance) The firm has submitted detail of nomenclature,
process and controls, tests for impurity & related
substances, specifications, analytical procedures and
Real time: 30°C ± 2°C, RH: 65% ± 5% for 24
months
Accelerated: 40°C ± 2°C, RH: 75% ± 5% for 6
months
Batches: (160108, 160124, 160220)
Metformin HCL:
Real time: 30°C ± 2°C, RH: 65% ± 5% for 48
months
months
Batches: (MEF/1410027, MEF/1410028,
MEF/1410029)
(including dissolution testing at acidic and buffer
medium) and its verification studies, batch analysis
product.
Pharmaceutical equivalence and The Firm has performed pharmaceutical equivalence
comparative dissolution profile and comparative dissolution profile of their
developed formulation Deglu-Met 5mg/850mg
Tablet (B # ST21A033) with comparator product
Dapa-Met 5mg/850mg Tablet (B #136549) of M/s
Hilton Pharma. Pvt. Ltd. in pH 1.2, acetate buffer pH
4.5 and phosphate buffer pH 6.8. The results of CDP
showed that release profile of both test and
comparator products were comparable. Calculation
of f2 factor is not required as both metformin and
dapagliflozin releases from test and comparator
product more than 85 % in 15 minutes in all three-
pH medium
Analytical method validation/verification Firm have submitted method validation studies
of product including linearity, range, accuracy, precision,
specificity.
Manufacturer of API Dapagliflozin: Fuxin Long Rui Pharmaceutical Co. Ltd., Fluoride Industrial
park, Fuxin city, Liaoning province, 123000, China.
Metformin HCL: Aarti Drugs Limited., Plot No. 211 - 213, Road No.2
G.I.D.C., Sarigam, Dist.: Valsad, Gujarat. INDIA.396155
API Lot No. Dapagliflozin: DG-20190327-D01-DG06-05
Metformin HCL: MEF/10030953
Description of Pack Alu-Alu blister packed in unit carton (1×14’s)
Real Time: 0, 3,6, 9, 12, 18, 24 (Months)
Batch No. ST21B033 ST21B034 ST21B035
No. of Batches 03
1. Reference of previous approval of The firm has referred to previous inspection of
applications with stability study data of the stability data of the same dosage form on the basis of
firm (if any) which Registration Board in 289th meeting decided
to approve registration of Promig Plus 500mg/20mg
Tablet and Promig Plus 375mg/20mg Tablet.
Inspection date: 14th March, 2019
The firm has provided data loggers with stability
chambers.
2. Approval of API/ DML/GMP certificate of Dapagliflozin: The firm has submitted GMP
API manufacturer issued by concerned certificate for M/s Fuxin Long Rui Pharmaceutical
regulatory authority of country of origin. Co., Ltd, China issued by Liaoning Fuxin
Management Committee for Fluoride Industrial
Development Zone. The certificate is valid till 23-
08-2023
Firm has submitted copy of Drug Manufacturing
License (DML # Liao20150233) of Fuxin Long Rui
Pharmaceutical Co. Ltd., China issued by Food &
Drug Administration, Liaoning Province China. The
certificate is valid till 20-12-2022.
Metformin HCL: The firm has submitted GMP
certificate for Aarti Drugs Limited India issued by
Food & Drug Control Administration Gandhinagar
India. The certificate is valid till 19-03-2023
3. Documents for the procurement of API with Dapagliflozin: The firm has submitted attested copy
approval from DRAP (in case of import). of invoice for the import of dapagliflozin (1.5 Kg,
Invoice # HN19120501-H) dated 05-12-2019 and
attested copy of AD (I&E) DRAP, Islamabad
clearance certificate dated 10-01-2020.
Metformin HCL: The firm has submitted attested
copy of invoice for the import of Metformin HCl
(1000 Kg, Invoice # EXP/302/20-21) dated 15-5-
2020, and attested AD (I&E) DRAP, Islamabad
4. Data of stability batches will be supported Firm has submitted record of testing of all batches
by attested respective documents like along with chromatograms, raw data sheets, COA
chromatograms, Raw data sheets, COA, and summary data sheets.
5. Compliance Record of HPLC software Compliance Record of HPLC software 21CFR &
21CFR & audit trail reports on product Audit trail on testing reports of product submitted.
testing
6. Record of Digital data logger for Firm has submitted record of data logger for
temperature and humidity monitoring of temperature and humidity monitoring of real time
stability chambers (real time and and accelerated stability chambers.
accelerated)
1.3.4 • Submit latest GMP inspection report conducted with
in last three years
1.5.2 • Mention the salt and hydrated form of dapagliflozin
in label claim and adjust its weight in batch formula
considering the salt and hydrated form
• Submit the fee of Rs. 30,000 for correction/pre-
approval change in composition (correction / change
of salt and hydrated form of the drug substance), as
per notification No.F.7-11/2012-B&A/DRAP dated
13-07-2021.
2.3.R.1.1 • You have not mentioned the salt and hydrated form
of dapagliflozin BMR. Moreover, salt factor and
hydrated form was not considered while dispensing
the API dapagliflozin, clarify?
3.2.S.4 • Assay test for drug substance Metformin is
performed by titration by both drug substance
manufacturer & drug product manufacturer instead
by HPLC as per USP 44
• Verification study for metformin performed as per
titration method instead by HPLC as per USP 44
3.2.P.1 • You have not mentioned the salt and hydrated form
of dapagliflozin in composition as well as in batch
formula section 3.2.P.3.2 as per reference product.
Mention the salt and hydrated form of dapagliflozin
3.2.P.2 • You have not performed CDP and pharmaceutical
equivalence against the innovator brand justify?
3.2.P.2.1.1 • Compatibility studies of the Drug Substance(s) with
excipients shall be provided as the qualitative
composition of the formulation is not similar to
innovator / reference product.
Applied XIGDUO tablet
product
Dapagliflozin Dapagliflozin as
Metformin HCl dapagliflozin
propanediol
monohydrate
Metformin HCl
Maize Starch
Sodium starch sodium starch glycolate
glycolate type A
Magnesium Magnesium Stearate
Stearate
Microcrystalline Microcrystalline
cellulose cellulose
Hydroxypropyl
• cellulose
3.2.P.8 • Submit 6 month stability study data at both real
th
time and accelerated conditions

• Value for label claim mentioned in calculation
formula for determining the assay of metformin at 3rd
month time point of accelerated and real stability
study data of Batch # ST21B033, Batch # ST21B034
and Batch # ST21B035 is not according to the
applied formulation, clarify?
• Different volume of dissolution media, label claim
and dilution mentioned in calculation formula for
determining the dissolution of metformin at 3rd
month time point of accelerated and real time
stability study of Batch # ST21B033, Batch #
ST21B034 and Batch # ST21B035 than that
mentioned in analytical procedure, clarify?
• Different volume of dissolution media mentioned in
calculation formula for determining the dissolution
of dapagliflozin at 3rd month time point of
accelerated and real time stability study of Batch #
ST21B033, Batch # ST21B034 and Batch #
ST21B035 than that mentioned in analytical
procedure, clarify?
within six months.
197. Name, address of Applicant / Marketing M/s Global Pharmaceuticals (Pvt.) Ltd. Plot # 204-
Authorization Holder 205 Industrial Triangle, kahuta Road, Islamabad,
Pakistan
Name, address of Manufacturing site. M/s Global Pharmaceuticals (Pvt.) Ltd. Plot # 204-
205 Industrial Triangle, kahuta Road, Islamabad,
Pakistan
☐ Importer
☐ Export sale
The proposed proprietary name / brand Deglu-Met 5mg/1000mg Tablet
name
Pharmaceutical ingredient (API) per unit Dapagliflozin…….5mg
Metformin HCL….1000mg
Pharmacotherapeutic Group of (API) sodium-glucose co-transporter 2 (SGLT2)
inhibitors.
biguanide class of antidiabetics
Reference to Finished product specifications Innovator specs
The status in reference regulatory XIGDUO 5mg/1000mg Tablet. (Health Canada
authorities approved)
For generic drugs (me-too status) Dapa-Met 5mg/1000mg Tablet by M/s Hilton
Pharma (Reg# 093072)
GMP status of the Finished product GMP certificate issued on 24-12-2018 based on
manufacturer inspection conducted on 24-10-2018.
Name and address of API manufacturer. Dapagliflozin: Fuxin Long Rui Pharmaceutical Co.
Ltd., Fluoride Industrial park, Fuxin city, Liaoning
province, 123000, China.
Metformin HCL: Aarti Drugs Limited., Plot No.
211 - 213, Road No.2 G.I.D.C., Sarigam, Dist.:
Valsad, Gujarat. INDIA.396155
Real time: 30°C ± 2°C, RH: 65% ± 5% for 24 months
months
Batches: (160108, 160124, 160220)
Metformin HCL:
Real time: 30°C ± 2°C, RH: 65% ± 5% for 48 months
months
Batches: (MEF/1410027, MEF/1410028,
MEF/1410029)
its verification studies, batch analysis and
product.
Pharmaceutical equivalence and The Firm has performed pharmaceutical equivalence
comparative dissolution profile and comparative dissolution profile of their
developed formulation Deglu-Met 5mg/1000mg
Tablet (B # ST21B030) with comparator product
Dapa-Met 5mg/1000mg Tablet (B #135679) of M/s
Hilton Pharma. Pvt. Ltd. in pH 1.2, acetate buffer pH
4.5 and phosphate buffer pH 6.8. The results of CDP
showed that release profile of both test and
comparator products were comparable. Calculation
of f2 factor is not required as both metformin and
dapagliflozin releases from test and comparator
product more than 85 % in 15 minutes in all three-
pH medium
Analytical method validation/verification of Not submitted
product
Manufacturer of API Dapagliflozin: Fuxin Long Rui Pharmaceutical Co. Ltd., Fluoride Industrial
park, Fuxin city, Liaoning province, 123000, China.
Metformin HCL: Aarti Drugs Limited., Plot No. 211 - 213, Road No.2
G.I.D.C., Sarigam, Dist.: Valsad, Gujarat. INDIA.396155
API Lot No. Dapagliflozin: DG-20190327-D01-DG06-05
Metformin HCL: MEF/10030953
Real Time: 0, 3,6, 9, 12, 18, 24 (Months)
Batch No. ST21B030 ST21B031 ST21B032
No. of Batches 03
applications with stability study data of the stability data of the same dosage form on the basis of
firm (if any) which Registration Board in 289th meeting decided to
approve registration of Promig Plus 500mg/20mg
Tablet and Promig Plus 375mg/20mg Tablet.
Inspection date: 14th March, 2019
chambers.
2. Approval of API/ DML/GMP certificate of Dapagliflozin: The firm has submitted GMP
API manufacturer issued by concerned certificate for M/s Fuxin Long Rui Pharmaceutical
regulatory authority of country of origin. Co., Ltd, China issued by Liaoning Fuxin
Management Committee for Fluoride Industrial
Development Zone. The certificate is valid till 23-08-
2023
License (DML # Liao20150233) of Fuxin Long Rui
Pharmaceutical Co. Ltd., China issued by Food &
Drug Administration, Liaoning Province China. The
Metformin HCL: The firm has submitted GMP
certificate for Aarti Drugs Limited India issued by
Food & Drug Control Administration Gandhinagar
India. The certificate is valid till 19-03-2023
3. Documents for the procurement of API with Dapagliflozin: The firm has submitted attested copy
approval from DRAP (in case of import). of invoice for the import of dapagliflozin (1.5 Kg,
Invoice # HN19120501-H) dated 05-12-2019 and
attested copy of AD (I&E) DRAP, Islamabad
Metformin HCL: The firm has submitted attested
copy of invoice for the import of Metformin HCl
(1000 Kg, Invoice # EXP/302/20-21) dated 15-5-
2020, and attested AD (I&E) DRAP, Islamabad
4. Data of stability batches will be supported by Firm has submitted record of testing of all batches
attested respective documents like along with chromatograms, raw data sheets, COA
chromatograms, Raw data sheets, COA, and summary data sheets.
5. Compliance Record of HPLC software Compliance Record of HPLC software 21CFR &
21CFR & audit trail reports on product Audit trail on testing reports of product submitted.
testing
6. Record of Digital data logger for temperature Firm has submitted record of data logger for
and humidity monitoring of stability temperature and humidity monitoring of real time
chambers (real time and accelerated) and accelerated stability chambers.

1.3.4 • Submit latest GMP inspection report conducted
with in last three years
1.5.2 • Mention the salt and hydrated form of dapagliflozin
• Submit the fee of Rs. 30,000 for correction/pre-
approval change in composition (correction / change
of salt and hydrated form of the drug substance), as
per notification No.F.7-11/2012-B&A/DRAP dated
13-07-2021.
2.3.R.1.1 • You have not mentioned the salt and hydrated form
of dapagliflozin BMR. Moreover, salt factor and
hydrated form was not considered while dispensing
the API dapagliflozin, clarify?
3.2.S.4 • Assay test for drug substance Metformin is
performed by titration by both drug substance
manufacturer & drug product manufacturer instead
by HPLC as per USP 44
• Verification study for metformin performed as per
titration method instead by HPLC as per USP 44
3.2.P.1 • You have not mentioned the salt and hydrated form
of dapagliflozin in composition as well as in batch
formula section 3.2.P.3.2 as per reference product.
Mention the salt and hydrated form of dapagliflozin
3.2.P.2 • You have not performed CDP and pharmaceutical
equivalence against the innovator brand justify?
3.2.P.2.1.1 • Compatibility studies of the Drug Substance(s) with
excipients shall be provided as the qualitative
Applied XIGDUO tablet
product
Dapagliflozin Dapagliflozin as
Metformin HCl dapagliflozin
propanediol
monohydrate
Metformin HCl
Maize Starch
Sodium starch sodium starch glycolate
glycolate type A
Magnesium Magnesium Stearate
Stearate
Microcrystalline Microcrystalline
cellulose cellulose
Hydroxypropyl
cellulose
3.2.P.5.3 • Analytical method validation report is not
submitted
3.2.P.8 • Submit 6th month stability study data at both real
time and accelerated conditions
• The volume of dissolution media mentioned in
of metformin at 3rd month time point of accelerated
and real time stability study of Batch # ST21B030,
Batch # ST21B031 and Batch # ST21B032 is
different than that mentioned in analytical
procedure, clarify?
• The volume of dissolution media mentioned in
of dapagliflozin at 3rd month time point of
accelerated and real time stability study of Batch #
ST21B030, Batch # ST21B031 and Batch #
ST21B032 is different than that mentioned in
analytical procedure, clarify?
within six months.
198. Name, address of Applicant / Marketing M/s Jawa Pharmaceuticals Private Limited., 112/10
Authorization Holder Quaid-e-Azam Industrial Area Kot Lakhpat, Lahore,
Name, address of Manufacturing site. M/s Jawa Pharmaceuticals Private Limited., 112/10
Quaid-e-Azam Industrial Area Kot Lakhpat, Lahore,
☐ Importer
☐ Export sale
Cholein Tablet USP 40mg
name
Strength / concentration of drug of Each Film Coated Tablet contains:
Active Pharmaceutical ingredient (API) Atorvastatin (as calcium trihydrate)…….… 40mg
per unit
Pharmacotherapeutic Group of (API) HMG CoA reductase inhibitors
USP Specifications
specifications
Proposed Pack size 1 x 10’s
The status in reference regulatory Atorvastatin 40 mg film coated Tablet by M/s
authorities Dexcel®-Pharma Ltd.7 Sopwith Way, Drayton Fields,
Daventry, Northamptonshire, NN11 8PB, UK,
MHRA Approved
For generic drugs (me-too status) Truva Tablet 40mg by Sami Pharmaceuticals (Reg#
100511)
GMP status of the Finished product The firm have submitted cGMP certificate issued on
manufacturer 06-07-2020 based on inspection conducted on 04-03-
2020
Name and address of API manufacturer. Zhejiang Haisen Pharmaceutical Co., Ltd., Xiangtan
Village, Liushi Street, Dongyang City, Zhejiang
Province, China
process and controls, tests for related substances,
specification, container closure system and stability
Batches: (5616010201, 5616010202, 5616010203)
product.
Pharmaceutical equivalence and CDP has been performed against the Lipitor Tablet
comparative dissolution profile (40mg) by Pfizer Pharma in Acid media (pH 1.2),
acetate Buffer (pH 4.5) & Phosphate Buffer (pH 7).
The values for f2 is in the acceptable range
Analytical method validation/verification Firm have submitted method verification studies
of product including accuracy, precision and specificity.
Manufacturer of API M/s Zhejiang Haisen Pharmaceutical Co., Ltd., Xiangtan Village, Liushi Street,
Dongyang City, Zhejiang Province, China
API Lot No. 5620051201
Description of Pack PVC/aluminum foil blister packs - then packed in the bleach board box.
(Container closure
system)
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. Trial 01 Trial 02 Trail 03
Batch Size 10,000 tablets 10,000 tablets 10,000 tablets
No. of Batches 03
1. Reference of previous approval of The firm has not submitted any document.
the firm (if any)
2. Approval of API/ DML/GMP certificate The firm has submitted copy of GMP certificate for
of API manufacturer issued by concerned M/s Zhejiang Haisen Pharmaceutical Co., Ltd.,
regulatory authority of country of origin. Xiangtan Village, Liushi Street, Dongyang City,
Zhejiang Province, China issued by China Food
& Drug Administration. The certificate is valid till 21-
08-201.
License (DML # ZHE20000394) of M/s Zhejiang
Haisen Pharmaceutical Co., Ltd., China issued by
State Food & Drug Administration, China. The
3. Documents for the procurement of API Not submitted
import).
4. Data of stability batches will be supported Firm have submitted Data of stability batches
by attested respective documents like supported by attested respective documents like
chromatograms, Raw data sheets, COA, chromatograms and summary data sheets etc.
testing
6. Record of Digital data logger for Firm has submitted Record of Digital data logger for
accelerated)
1.3.3 In status of applicant you have mentioned “Is
involved in none of the above (contract giver)”,
clarify?
2.3.R.1 Provide copy of Batch Manufacturing Record
(BMR) for all the batches of drug product for which
stability studies data is provided in Module 3 section
3.2.P.8.3>
3.2.S.4 • Test for enantiomeric purity is not included in
specifications although given in USP monograph
of drug substance, clarify?
• Copies of analytical procedures used for routine
testing of the Drug substance /Active
Pharmaceutical Ingredient by Drug Product
manufacturer is required.
3.2.S.5 • COA of primary / secondary reference standard
including source and lot number shall be provided.
3.2.P.2.1.1 • Compatibility studies of the Drug Substance(s)
with excipients shall be provided as the qualitative
(Composition of Applied Formulation:
Atorvastatin calcium, Microcrystalline cellulose
(avicel 200), Magnesium stearate, Sodium starch
glycolate (Primogel), silica dioxide)
• You have not performed Pharmaceutical
equivalence of the applied drug with the innovator
/ reference / comparator product, justify?
3.2.P.5 • In given specification of drug product, in
identification test you have mentioned
“identification for cefixime” while the applied
product is atorvastatin calcium, clarify?
• Test for uniformity of dosage unit (content
uniformity) is not included in specifications and
not performed in batch analysis although given in
USP monograph of drug product, clarify?
3.2.P.8 • Stability data reflect that dissolution test has not
been performed after initial time point throughout
stability studies at both accelerated and real time
conditions, justify?
• Submit COA, Raw data sheets & analytical record
of stability studies containing calculation formula
for both assay & dissolution test
• Submit documents for the procurement of API
with approval from DRAP.
199. Name, address of Applicant / ATCO Laboratories Limited., B-18, S.I.T.E., Karachi -
Marketing Authorization Holder 7500, Pakistan
Name, address of Manufacturing site. ATCO Laboratories Limited., B-18, S.I.T.E., Karachi -
7500, Pakistan
☐ Importer
Slip#489820062060)
The proposed proprietary name / Ondansetron Tablet 4mg
brand name
antagonists.
specifications
Proposed Pack size 7’s, 10’s, 14’s, 20’s, 28’s, 30’s.
authorities
For generic drugs (me-too status) Ongene 4mg Tablet by M/s High-Q Pharmaceuticals
(Reg#091206)
GMP status of the Finished product The firm was inspected on 22-03-2022 & 05-04-2022 by
manufacturer the panel for renewal of DML, regularization of section as
per layout plan and additional sections and decision of
panel is:
products registered in the name of firm being produced at
the site and overall good maintenance of plan and the
required documentation and SOPs, the panel
regularization of sections as per layout plan and approval
of additional sections
Name and address of API M/s Anugraha Chemicals, No D-47 to D-50, C-62 and C-
manufacturer. 63, KSSIDC, Industrial Estate, Doddaballapur, Bengaluru
Rural District-561203 India
Summarized information related to nomenclature,
controls, specifications, analytical procedures and its
submitted.
drug product.
(AOND-17002, AOND-17003, AOND-17004) conducted
for 06 months
Real time stability study of two batches AOND-17002,
AOND-17003, conducted for 36 months while real time
stability study of one batch AOND-17004 conducted for
24 months
GlaxoSmithKline Research Triangle Park, NC 27709
Marketed by: Novartis Pharmaceuticals UK Limited
Dissolution, disintegration).
CDP of ondansetron 8mg tablets has been performed
against the zofran 8mg tablets in Acid media (pH 1.2),
acetate buffer (pH 4.5) & Phosphate Buffer (pH 6.8). The
values for f2 are in the acceptable range.
Analytical method Firm has submitted method verification studies including
validation/verification of product range, accuracy, precision, specificity and robustness.
Description of Pack ALU-ALU Blister pack packed in unit carton
(Container closure
system)
Batch No. MA096C MA097C MA098C
No. of Batches 03
applications with stability study data of authenticity of stability data of Rofl 500mcg tablet on the
the firm (if any) basis of which Registration Board in its 277th meeting
dated 27-29 December, 2017 decided to approve
registration of Rofl 500mcg tablet.
Adequate monitoring and control are available for stability
chambers
2. Approval of API/ DML/GMP The firm have submitted copy of GMP certificate
certificate of API manufacturer issued #DCD/SPL.CL-1/CR-1510/2020-21 dated 06-02-2021 of
by concerned regulatory authority of M/s Anugraha Chemicals, No D-47 to D-50, C-62 and C-
country of origin. 63, KSSIDC, Industrial Estate, Doddaballapur, Bangaluru
Rural District-561203 India valid upto one year from the
date of issue.
#DCD/MFG/Applicant Id-240 dated 26/06/2020 of M/s
Anugraha Chemicals, No D-47 to D-50, C-62 and C-63,
KSSIDC, Industrial Estate, Doddaballapur, Bangaluru
Rural District-561203 India valid upto 13/02/2025
3. Documents for the procurement of API Firm has submitted copy of invoice # OND1200 dated 10-
with approval from DRAP (in case of 11-2020 for import on 300gm of Ondansetron HCl
AOND-20013 in the name of M/s Atco Laboratories Ltd
Karachi form M/s Agraha Chemical India. However, the
invoice is not attested by AD (I&E) DRAP field office
4. Data of stability batches will be Firm has submitted data of stability batches supported by
supported by attested respective attested respective documents like chromatograms, Raw
documents like chromatograms, Raw data sheets, COA, summary data sheets etc.
etc.
testing
temperature and humidity monitoring temperature and humidity monitoring of stability
of stability chambers (real time and chambers (real time and accelerated)
accelerated)
1.6.5 Submit valid GMP certificate of drug substance
manufacturer
3.2.S.4 • Copies of the analytical procedures used for
routine testing of the Drug substance / Active
Pharmaceutical ingredient by Drug Product
• Analytical Method Verification studies including
submitted.
3.2.S.5 Firm has submitted COA of primary reference
standard which follows usp specifications and
secondary reference standard which has followed
Ph. Eu specifications while applied product follows
bp specifications
3.2.P.2 • Submit compatibility study as the qualitative
composition of the applied formulation is not
similar to innovator / reference product.
Applied product Zofran 4mg tab
Lactose Lactose
anhydrous
Sodium starch Microcrystalline
glycolate Cellulose
Crospovidone Pregelatinized maize
starch
Magnesium Magnesium Stearate,
stearate
Opadry white Methyl hydroxypropyl
cellulose
Purified water Titanium dioxide
(E171)
Iron oxide (E172)
• Justification is required as the pharmaceutical

equivalence and CDP of higher strength has been
submitted
• Justify why the pharmaceutical equivalence
study does not include complete testing of the
drug product and the innovator product including
the tests recommended by USP monograph
(dissolution, identification, assay, uniformity of
dosage unit).
• Provide details of innovator product used during
pharmaceutical equivalence study (batch #, mfg,
exp)
3.2.P.5.1 Justification for finished product specifications of
USP is required as the drug substance has been
analysed as per BP specifications by M/s Atco.
3.2.P.6 Firm has submitted COA of secondary reference
standard which has followed Ph. Eu specifications
while the applied product follows USP
specifications
3.2.P.8 Submit documents for the procurement of API with
approval from DRAP.
within six months.
200. Name, address of Applicant / Marketing M/s Honig Pharmaceuticals., 14 km Adyala Road,
Authorization Holder Rawalpindi.
Name, address of Manufacturing site. M/s Honig Pharmaceuticals., 14 km Adyala Road,
Rawalpindi.
☐ Importer
☐ Export sale
The proposed proprietary name / brand Valoton 40 mg tablets
name
Strength / concentration of drug of Active Each Film coated tablets contains:
Pharmaceutical ingredient (API) per unit Valsartan………….40 mg
Pharmacotherapeutic Group of (API) Angiotensin II Receptor antagonist
USP
specifications
The status in reference regulatory Diovan (40mg, 80mg, 160mg, 320mg ) film coated
For generic drugs (me-too status) Valtec 40mg Tablet by M/s Tabros Pharrma
(Reg#055899)
GMP status of the Finished product ------------
manufacturer
Name and address of API manufacturer. Zhejiang Menovo Pharmaceutical Co., Ltd., No. 8, Jing
13 Road, Hangzhou Gulf, Shangyu Economic and
Technological Development Zone, 312369, China
manufacturing process and controls, specifications,
analytical procedures and its verification, batch analysis
and controls, specifications, analytical procedures batch
of drug substance
Batches: (VAL-D-4-081001, VAL-D-4-081002, VAL-
D-4-081003)
impurities, specifications, analytical procedure batch
of drug product.
Pharmaceutical equivalence and Pharmaceutical Equivalence has been established
comparative dissolution profile against the brand Valtec 40mg tablet by M/s Tabros
pharma by performing quality tests (Identification,
Assay, Uniformity of dosage unit, dissolution).
Valtec 40mg tablet by M/s Tabros pharma in 0.1 N HCl,
4.5 pH acetate buffer and 6.8pH phosphate buffer. The
values for f2 is in the acceptable range
Analytical method validation/verification Not submitted
of product

Manufacturer of API Zhejiang Menovo Pharmaceutical Co., Ltd., No. 8, Jing 13 Road, Hangzhou Gulf,
Shangyu Economic and Technological Development Zone, 312369, China
API Lot No. VAL-130901
Description of Pack Alu Alu Blister Packed in unit carton
Real Time: 0, 3, 6, 9, 12, 18 and 24 (Months)
No. of Batches 03
1. Reference of previous approval of No reference provided
firm (if any)
API manufacturer issued by concerned #ZJ20190121 dated 28/10/2019 of M/s Zhejiang
regulatory authority of country of origin. Menovo Pharmaceutical Co. Ltd., No. 8, Jing 13 Road,
Hangzhou Gulf, Shangyu Economic and Technological
Development Zone, 312369, China issued by China
Food & Drug Administration valid upto 27/10/2024
import).
4. Data of stability batches will be supported Data of stability batches supported by attested respective
by attested respective documents like documents Raw data sheets, summary data sheets is
chromatograms, Raw data sheets, COA, submitted
5. Compliance Record of HPLC software The firm submitted that their HPLC system is not 21
21CFR & audit trail reports on product CFR compliant
testing
accelerated)
• Differential fee of registration Rs. 10, 000/- shall be submitted
1.3.5 • Latest GMP inspection report/ GMP certificate of the
manufacturing unit issued within the last three years shall be
submitted
2.3.R.1 • Provide copy of Batch Manufacturing Record (BMR) for all the
batches of drug product for which stability studies data is
provided in Module 3 section 3.2.P.8.3>
3.2.S.4 • Copies of the analytical procedures used for routine testing of
the Drug substance /Active Pharmaceutical Ingredient by Drug
substance manufacturer is required.
• Analytical Method Verification studies including specificity,
accuracy and repeatability (method precision) performed by the
Drug Product manufacturer for drug substance(s) shall be
submitted.
3.2.S.7 The test performed in stability study of drug substance by the drug
substance manufacturer is different than that recommended by
USP and submitted specifications, clarification is required
Specifications Accelerated Real time USP
conditions conditions
Appearance Identification
Identification Residue on
(HPLC) ignition
Solubility Related
substances/
impurities
Sulphated ash Water
determination
Water (by Absorbance
K.F)
Heavy metals Assay
Assay (On
anhydrous
basis)
3.2.P.2 • Submit compatibility study as the qualitative composition of the
applied formulation is not similar to innovator / reference
product.
Applied Innovator tablet
product
Valsartan Valsartan
Sodium Starch colloidal silicon dioxide,
Glycolate and
(Primojel )
Starch(Maize) ---------
DE-Ionized ---------------
Water
Microcrystalline microcrystalline
Cellulose cellulose,
(Avicel 102)
Magnesium magnesium stearate,
Stearate
Talcum Purified ------------
Cross crospovidone,
Povidone(Cross
linked
Carboxymethyl
cellulose
sodium)
hydroxypropyl hydroxypropyl
methylcellulose, methylcellulose,
Titanium Titanium dioxide.
dioxide
Isopropyl Iron oxides (yellow,
alcohol black and/or red),
Off white color
Polyethylene polyethylene glycol
glycol 6000 8000,
• Justification is required since pharmaceutical equivalence and
CDP have not been conducted against the innovator product.
• Provide details of reference product including batch No, mfg
date and exp date
• Results of CDP in pH 6.8 buffer are contradictory to the
dissolution limits recommended by USP monograph.
3.2.P.5 • The limits of average weight test given in specifications is
249mg±7.5% (subject to change with variation in potency of
pellets) while applied products is tablet.
accuracy and repeatability (method precision) for drug product
shall be submitted.
3.2.P.8 • Submit documents for the procurement of API with approval
from DRAP (in case of import).
• The API batch No# mentioned in batch analysis of drug
substance is VAL-130901 while API batch No. mentioned in
stability summary sheets is 40000290161. Clarification is
required whether same batch number material mentioned in
batch analysis is used for manufacturing of stability batches or
otherwise
• The stability study of all three batches at both accelerated and
real time conditions at 3rd month time point is performed one
month before the completion of three months and the same
procedure adopted for subsequent time point respectively,
clarification is required
• Clarification is required since the stability study data at
accelerated and real time conditions shows that Assay test has
been performed on UV instead of HPLC as per USP monograph
• The submitted raw data sheet at each time point doesn’t specify
the conditions (real time and accelerated) at which the stability
study is performed, clarification is required
• No UV spectra provided for the performed dissolution study
• Submit Record of Digital data logger for temperature and
humidity monitoring of stability chambers (real time and
accelerated)
• COA of stability batches is not submitted.
within six months.
201. Name, address of Applicant / Marketing M/s Honig Pharmaceuticals., 14 km Adyala Road,
Name, address of Manufacturing site. M/s Honig Pharmaceuticals., 14 km Adyala Road,
Rawalpindi.
☐ Importer
☐ Export sale
Valoton 80 mg tablets
name
Strength / concentration of drug of Active Each Film coated tablets contains:
Pharmaceutical ingredient (API) per unit Valsartan………….80 mg
Pharmacotherapeutic Group of (API) Angiotensin II Receptor antagonist
USP
specifications
The status in reference regulatory Diovan (40mg, 80mg, 160mg, 320mg ) film coated
For generic drugs (me-too status) Valtec 80mg Tablet by M/s Tabros Pharrma
(Reg#039772)
GMP status of the Finished product ------------
manufacturer
Name and address of API manufacturer. Zhejiang Menovo Pharmaceutical Co., Ltd., No. 8, Jing
13 Road, Hangzhou Gulf, Shangyu Economic and
Technological Development Zone, 312369, China
and controls, specifications, analytical procedures batch
of drug substance
Batches: (VAL-D-4-081001, VAL-D-4-081002, VAL-
D-4-081003)
impurities, specifications, analytical procedure batch
of drug product.
comparative dissolution profile against the brand Valtec 80mg tablet by M/s Tabros
pharma by performing quality tests (Identification,
Assay, Uniformity of dosage unit, dissolution).
Valtec 80mg tablet by M/s Tabros pharma in 0.1 N HCl,
4.5 pH acetate buffer and 6.8pH phosphate buffer. The
values for f2 is in the acceptable range
of product

Manufacturer of API Zhejiang Menovo Pharmaceutical Co., Ltd., No. 8, Jing 13 Road, Hangzhou
Gulf, Shangyu Economic and Technological Development Zone, 312369,
China
API Lot No. VAL-130901
Description of Pack Alu Alu Blister Packed in unit carton
No. of Batches 03
1. Reference of previous approval of No reference provided
firm (if any)
API manufacturer issued by concerned #ZJ20190121 dated 28/10/2019 of M/s Zhejiang
regulatory authority of country of origin. Menovo Pharmaceutical Co. Ltd., No. 8, Jing 13 Road,
Hangzhou Gulf, Shangyu Economic and Technological
Development Zone, 312369, China issued by China
Food & Drug Administration valid upto 27/10/2024
3. Documents for the procurement of API with Not submitted
approval from DRAP (in case of import).
4. Data of stability batches will be supported Data of stability batches supported by attested respective
by attested respective documents like documents Raw data sheets, summary data sheets is
chromatograms, Raw data sheets, COA, submitted
5. Compliance Record of HPLC software The firm submitted that their HPLC system is not 21
21CFR & audit trail reports on product CFR compliant
testing
accelerated)
• Differential fee of registration Rs. 10, 000/- shall be submitted
1.3.3 • Status of applicant is not specified
1.3.5 • Latest GMP inspection report/ GMP certificate of the
manufacturing unit issued within the last three years shall be
submitted
2.3.R.1 • Provide copy of Batch Manufacturing Record (BMR) for all the
batches of drug product for which stability studies data is
3.2.S.4 • Copies of the analytical procedures used for routine testing of
the Drug substance /Active Pharmaceutical Ingredient by Drug
accuracy and repeatability (method precision) performed by the
Drug Product manufacturer for drug substance(s) shall be
submitted.
3.2.S.7 The test performed in stability study of drug substance by the drug
substance manufacturer is different than that recommended by
USP and submitted specifications, clarification is required
Specifications Accelerated Real time USP
conditions conditions
Appearance Identification
Identification Residue on
(HPLC) ignition
Solubility Related
substances/
impurities
Sulphated ash Water
determination
Water (by Absorbance
K.F)
Heavy metals Assay
Assay (On
anhydrous
basis)
3.2.P.2 • Submit compatibility study as the qualitative composition of the
applied formulation is not similar to innovator / reference
product.
Applied Innovator tablet
product
Valsartan Valsartan
Sodium Starch colloidal silicon dioxide,
Glycolate and
(Primojel )
Starch(Maize) ---------
DE-Ionized ---------------
Water
Microcrystalline microcrystalline
Cellulose cellulose,
(Avicel 102)
Magnesium magnesium stearate,
Stearate
Talcum Purified ------------
Cross crospovidone,
Povidone(Cross
linked
Carboxymethyl
cellulose
sodium)
hydroxypropyl hydroxypropyl
methylcellulose, methylcellulose,
Titanium Titanium dioxide.
dioxide
Isopropyl Iron oxides (yellow,
alcohol black and/or red),
Off white color
Polyethylene polyethylene glycol
glycol 6000 8000,
•
• Justification is required since pharmaceutical equivalence and
CDP have not been conducted against the innovator product.
• Provide details of reference product including batch No, mfg
date and exp date
• Justification is required since the results of weight variation test
(456.2mg for valoton and 454.63 for valtec tablets) are out of
specification in pharmaceutical equivalence
(limits…………280mg±7.5%)
• Results of CDP in pH 6.8 buffer are contradictory to the
dissolution limits recommended by USP monograph.
3.2.P.5 • Specification and analytical procedure for valoton 40mg tablets
is submitted instead of valoton 80mg tablets. Clarification is
required.
accuracy and repeatability (method precision) for drug product
shall be submitted.
• Same COA in batch analysis is submitted as that submitted in
valoton 40mg tablet. Results of all test are same except average
weight results
3.2.P.8 • Submit documents for the procurement of API with approval
from DRAP (in case of import).
• The API batch No# mentioned in batch analysis of drug
substance is VAL-130901 while API batch No. mentioned in
stability summary sheets is 40000290161. Clarification is
required whether same batch number material mentioned in
batch analysis is used for manufacturing of stability batches or
otherwise
• The stability study of all three batches at both accelerated and
real time conditions at 3rd month time point is performed one
month before the completion of three months and the same
procedure adopted for subsequent time point respectively,
clarification is required
• Clarification is required since the stability study data at
accelerated and real time conditions shows that Assay test has
been performed on UV instead of HPLC as per USP monograph
• The submitted raw data sheet at each time point doesn’t specify
the conditions (real time and accelerated) at which the stability
study is performed, clarification is required
• No UV spectra provided for the performed dissolution study
• Submit Record of Digital data logger for temperature and
humidity monitoring of stability chambers (real time and
accelerated)
• COA of stability batches is not submitted.
• Same stability study results have been reported as that for
Valoton 40mg strength.
• Same value of absorption of standard taken at all time point for
assay test. Similarly, same value of absorption of standard taken
at all time point for dissolution test. Clarification is required.
within six months.
202. Name, address of Applicant / Marketing M/s Jawa Pharmaceuticals Private Limited., 112/10
Authorization Holder Quaid-e-Azam Industrial Area Kot Lakhpat, Lahore,
Name, address of Manufacturing site. M/s Jawa Pharmaceuticals Private Limited., 112/10
Quaid-e-Azam Industrial Area Kot Lakhpat, Lahore,
☐ Importer
☐ Export sale
Details of fee submitted PKR 30,000/-: dated 22-06-2021 (Deposit
Slip#599036870370)
The proposed proprietary name / brand Phencol ophthalmic solution 0.5% w/v
name
Strength / concentration of drug of Each ml contains:
Active Pharmaceutical ingredient (API) Chloramphenicol BP…….… 5mg
per unit
Pharmaceutical form of applied drug Eye Drops
Pharmacotherapeutic Group of (API) Ophthalmologicals-Antibiotics
Reference to Finished product BP Specifications
specifications
The status in reference regulatory Chloramphenicol Eye Drops BP 0.5% w/v, MHRA
authorities Approved
For generic drugs (me-too status) Chlorin Eye drops by M/s NovaMed Pharmaceuticals
(Reg#084887)
GMP status of the Finished product The firm have submitted cGMP certificate issued on
manufacturer 06-07-2020 based on inspection conducted on 04-03-
2020
Name and address of API manufacturer. Mehta API Pvt. Ltd., Gut No. 546, 571, 519 & 520,
Village Kumbhavali, Taluka Palghar, District Palghar,
401506, Maharashtra India.
process and controls, specifications, analytical
justification of specification, container closure system
and stability studies of drug substance
Batches:(CHL/0010108, CHL/0020108,
CHL/0030108)
Pharmaceutical equivalence and Not submitted
comparative dissolution profile
Analytical method validation/verification Firm have submitted method verification studies
of product including accuracy, precision and specificity.
Manufacturer of API Mehta API Pvt. Ltd., Gut No. 546, 571, 519 & 520, Village Kumbhavali,
Taluka Palghar, District Palghar, 401506, Maharashtra India.
API Lot No. LT-OCHL/016/20-21
Description of Pack LDPE Plastic bottles with polypropylene nozzle and high density
(Container closure system) polyethylene (HDPE) cap. Pack size is 5ml in 10ml bottle
Batch No. Trial-01 Trial-02 Trial-03
Batch Size 03 Litres 03 Litres 03 Litres
Date of Initiation
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate The firm has submitted copy of GMP certificate of M/s
of API manufacturer issued by concerned Mehta API Pvt. Ltd., Gut No. 546, 571, 519 & 520,
Village Kumbhavali, Taluka Palghar, District Palghar,
401506, Maharashtra India. issued by Commissioner,
Food & Drugs Administration Maharashtra State India
valid till 18-09-2022.
import).
4. Data of stability batches will be supported Firm have submitted Data of stability batches
by attested respective documents like supported by respective documents like
chromatograms, Raw data sheets, COA, chromatograms and summary data sheets etc.
testing
6. Record of Digital data logger for Firm has submitted Record of Digital data logger for
accelerated)
1.5.4 • Pack size mentioned in module 1 is 10ml while pack
size mentioned in module 3 section 3.2.P.1 & 3.2.P.7
is 5ml in 10ml bottle, clarify?
2.3.R.1 • Provide copy of Batch Manufacturing Record
(BMR) for all the batches of drug product for which
stability studies data is provided in Module 3 section
3.2.P.8.3>
2.3. • Submit module II as per WHO QOS-PD template
3.2.S.4 • Specifications and analytical procedure of drug
substance by drug substance manufacturer are
provided as per USP monograph while specification
provided by drug product manufacturer are as per
BP. Clarification is required. Furthermore, Batch
analysis of drug substance by drug substance
manufacturer show tests as per BP monograph
• BP monograph uses HPLC method for assay test
while drug product manufacturer uses uv method for
assay test clarify?
3.2.P.2 • Submit Pharmaceutical equivalence of the applied
product against the innovator product
• Sterilization by gama radiation in microbial
attributes while by filtration in manufacturing
process 3.2.P.3.3, clarify?
3.2.P.5 • In batch analysis in assay test “assay for gentamycin
is written while the applied product is
chloramphenicol, clarification is required
3.2.P.8 • In stability study protocols you have mentioned
stability storage conditions as Real time: 30°C ± 2°C
/ 35% ± 5%RH and Accelerated: 40°C ± 2°C / 25% ±
5%RH and submit stability study at Real time: 30°C
± 2°C / 65% ± 5%RH and Accelerated: 40°C ± 2°C /
75% ± 5%RH, clarification is required
• Initial page of stability summary sheet containing
batch No. of FPP, API, storage conditions, date of
manufacturing, date of initiation of stability study is
not submitted
• Clarification is required since the limits for assay test
mentioned in stability summary sheet for all three
batches is 98-102% which is not as per
pharmacopeia.
• Submit documents for the procurement of API with
• Submit Compliance Record of HPLC software
• COA and raw data sheets of stability batches is not
submitted
• The submitted chromatograms at initial time point
does not contain batch no of applied product.
• Submit data of stability batches supported by
attested respective documents like chromatograms,
within six months.
203. Name, address of Applicant / Marketing M/s Ophth Pharma (Pvt) Ltd., Plot No. 241, Sector-24
Authorization Holder Korangi Industrial Area, Karachi, Pakistan
Name, address of Manufacturing site. M/s Ophth Pharma (Pvt) Ltd., Plot No. 241, Sector-24
Korangi Industrial Area, Karachi, Pakistan
☐ Importer
☐ Export sale
Details of fee submitted Rs.20,000/- dated 26-02-2021
Ophth Cyclovir Topical Cream 5%
name
Strength / concentration of drug of Active Each Gram Contains:
Pharmaceutical ingredient (API) per unit Acyclovir BP………..…50mg/g
Pharmaceutical form of applied drug Topical Cream
Pharmacotherapeutic Group of (API) Antiviral
BP Specifications
specifications
Proposed Pack size 10gm tube
Proposed unit price Rs. 800
ZOVIRAX Cream 5% w/w, USFDA Approved
authorities
For generic drugs (me-too status) Hepex Cream 5% by M/s Evolution Pharmaceuticals
(Reg# 091965)
GMP status of the Finished product The firm has submitted GMP certificate issued on 02nd
manufacturer October 2020 based on inspection conducted on 27th
September 2019
Name and address of API manufacturer. M/s Hubei Yitai Pharmaceutical Co. Ltd.
Fengchengyuan, Suburban District of Tianmen City
Hubei Province, China
nomenclature, structure, general properties, solubilities
manufacturing process and controls, specifications
and justification of specification, reference standard
Module III (Drug Substance) The firm has submitted detail of nomenclature
structure, general properties, solubilities, physical form
manufacturers, specifications, batch analysis and
Batches:(02190501, 02190502, 02190503)
Module-III (Drug Product): The firm has submitted detail of manufacturers
description of manufacturing process and controls
specifications, analytical procedure and its verification
studies, batch analysis and justification of specification
product.
comparative dissolution profile against the brand that is Zovirax Topical Cream by M/s
Barrett Hodgson by performing quality tests
(appearance, identification, fill weight, drug release).
of product
Manufacturer of API M/s Hubei Yitai Pharmaceutical Co. Ltd., Fengchengyuan, Suburban Distric
of Tianmen City, Hubei Province, China
API Lot No.
Description of Pack Printed aluminum tube with nozzle and cap packed in unit carton
Batch No. TB 101 TB 102 TB 103
Batch Size 5 Kg 5 Kg 5 Kg
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of No GMP certificate submitted
API manufacturer issued by concerned
3. Documents for the procurement of API with Not submitted
4. Data of stability batches will be supported Firm have submitted Data of stability batches supported
by attested respective documents like by respective documents like UV spectra, raw data
chromatograms, Raw data sheets, COA, sheets and summary data sheets etc.
summary data sheets etc. Raw data sheets does not show the storage conditions
and time point at which performance is done
testing
accelerated)
1.3.4 • Submit valid copy of DML as the submitted DML
is expired on 04-05-2021 and renewal of DML
submitted on 17-05-2021
1.3.5 • GMP inspection report/ GMP certificate of the
manufacturing unit issued within the last three
years shall be submitted
2.3.R.1 • Provide copy of Batch Manufacturing Record
(BMR) for all the batches of drug product for
which stability studies data is provided in Module
3 section 3.2.P.8.3>
3.2.S.4 • Copies of the analytical procedures used for
routine testing of the Drug substance by Drug
substance and drug Product manufacturer is
required.
• Analytical Method Verification studies including
submitted.
3.2.S.4.4 • Batch analysis of drug substance by drug
substance manufacturer follow USP
specifications while Finished product
manufacturer have tested the API as per BP
monograph, clarification is required
• Drug substance was tested on 18.05.2020 as per
submitted COA of API by drug product
manufacturer while batches were manufactured in
12-2019 before testing of API, clarify
3.2.S.5-6 • Container closure system data and reference
standard details are not submitted
3.2.S.7 • Long term stability data of drug substance is
submitted for 12 months only
3.2.P.1 • Justify the use of butylene paraben and methyl
paraben in formulation as the innovator product
does not contain these excipients.
Applied product Innovator product
(ZOVIRAX)
Stearic acid powder cetostearyl alcohol,.
Ethylene glycol mineral oil,
monostearate
Isopropyl myristate poloxamer 407,
Tween 80 propylene glycol,
Butylene paraben sodium lauryl
sulfate,
Propylene glycol water
Methyl paraben white petrolatum
Sorbitol solution
70%
Lavender oil
Purified water QS
• Pharmaceutical equivalence of applied product
states that product follows the USP specification,
while you have applied for BP specifications for
the applied product, justification is required
• Process validation protocols for applied product
shall be submitted
3.2.P.5 • The limits of assay test as per monograph of BP
pharmacopeia is 95-105% while you have applied
45-55mg/g (90-110%) which is different from
BP, clarification is required.
• Clarification is required since procedure of assay
test given in analytical procedure is by UV while
BP monograph for applied products states
performance by HPLC.
• Submit Analytical Method Verification studies
including specificity, accuracy and repeatability
(method precision) for drug product as per BP
method.
• The copies of complete analysis of at least two
batches shall be provided while you have
provided batch analysis of only one batch, justify?
3.2.P.6 • No details of reference standard is submitted
3.2.P.8 • Clarification is required since assay test is
performed by UV throughout stability study
instead by HPLC as recommended by BP.
• Submit documents for the procurement of API
with approval from DRAP (in case of import).
• Record of Digital data logger for temperature and
• Submit data of stability batches supported by
chromatograms, Raw data sheets, COA, summary
data sheets etc.
within six months.
Registration applications of New DML of human drugs on Form 5F
M/s Biogen Pharmaceuticals, 8-km Chakbeli Road Rawat Rawalpindi.

The Central Licensing Board in its 273rd meeting held on 15th January, 2020 has considered and
approved the grant of Drug Manufacturing License by way of formulation with following sections of
M/s Biogen Pharmaceuticals, 8-km Chakbeli Road Rawat Rawalpindi under Drug Manufacturing
License No. 000911 by way of Formulation vide approval letter No. F. 1-2/2019-Lic dated 14th February
2020.
Ground Floor
1 Dry Suspension (Cephalosporin) 2. Capsule Section (Cephalosporin)
Section
3 Dry Vial Section 4. Penem Injection Section
(Cephalosporin)
5 Ware House * ****************
First Floor
1 Tablet Section (General) 2 Capsule Section (General)
3 Sachet Section (General) 4 Cream Section (General)
5 Ointment Section (General) 6 Lotion Section (General)
7 Dry Vial Section (General) * ****************
Second Floor
1 Ampoule Section SVP (General) 2 Infusion Section (General)
3 Hydrocortisone Injection 4 Soft Gel Capsule General
(Steroid)
5 Quality Control Lab * ***************
Following applications have been submitted for registration by the firm.
204.Name, address of Applicant / Marketing M/s Biogen Life Sciences, 8-km Chakbeli Road
Authorization Holder Rawat Rawalpindi
Name, address of Manufacturing site. M/s Biogen Life Sciences, 8-km Chakbeli Road
Rawat Rawalpindi
☐ Importer
☐ Export sale
(Deposit Slip#01492435)
The proposed proprietary name / brand name OmeGen 20mg/1680mg Sachet
Strength / concentration of drug of Active Each Sachet contains:

Pharmaceutical ingredient (API) per unit Omeprazole…………………...20mg
Sodium bicarbonate………….1680mg
Pharmaceutical form of applied drug Immediate Release Powder for oral suspension
Pharmacotherapeutic Group of (API) Proton Pump Inhibitor
Reference to Finished product specifications Innovator Specefications
The status in reference regulatory authorities ZEGERID (20mg/packet ; 1.68gm/packet,
40mg/packet ; 1.68gm/packet) for Oral
Suspension USFDA Approved
For generic drugs (me-too status) Risek Insta Sachet 20mg + 1680mg by M/s Getz
Pharma (Reg# 58547)
manufacturer
Name and address of API manufacturer. Omeprazole:
M/s Everest Organics limited., Aroor Village,
Sadasivapet Mandal, Sangareddy Dist. Telangana
India
Sodium Bicarbonate:
M/s United Chem., 18-Warlley Moor Lane Leeds
West Workshire LS 12 4HX United Kingdom
process and controls, tests for impurity D, G &
related substances (impurity A & unspecified),
Stability studies Omeprazole:
omeprazole. Stability study is conducted at
accelerated conditions; 25°C ± 2°C / 60% ± 5%RH
for 06 months and at Real time conditions; 2-8°C
± for 36 months
Batches: OM/004/10, OM/005/10, OM/006/10)
medium) and its verification studies, batch
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence have been established
dissolution profile against the product that is Zegerid 20mg IR
Powder for oral suspension by M/s Santarus Inc.
by performing quality tests (Identification, Assay,
that is Zegerid 20mg IR Powder for oral
suspension by M/s Santarus Inc. in Acid media
(pH 1.2), Acetate Buffer (pH 4.5) & Phosphate
acceptable range.
Analytical method validation/verification of In method Validation studies only results for
product accuracy, precision is submitted.
Manufacturer of API Omeprazole:
M/s Everest Organics limited., Aroor Village, Sadasivapet Mandal,
Sangareddy Dist. Telangana India
Sodium Bicarbonate:
M/s United Chem., 18-Warlley Moor Lane Leeds West Workshire LS 12
4HX United Kingdom
API Lot No. Omeprazole: OME/E-143/21
Sodium Bicarbonate: 547908
Description of Pack Aluminum foil Sachet packed in packing box
Frequency Accelerated: 0, 3,6 (Months)
Batch No. T-01 T-02 T-03
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of Omeprazole:
API manufacturer issued by concerned Firm has submitted GMP certificate No#
regulatory authority of country of origin. L.Dis.No:64180/TS/2021 dated 09/08/2021 in
name of M/s Everest Organics Limited., Aroor
Village, Sadasivapet Mandal, Sangareddy Dist.
Telangana India valid upto 08/08/2022.
Sodium Bicarbonate:
M/s United Chem., 18-Warlley Moor Lane Leeds
West Workshire LS 12 4HX United Kingdom
3. Documents for the procurement of API with Not Submitted
1.3.2 • The name of applicant as per form 5F is
Biogen Life sciences while name
mentioned on DML is Biogen
Pharmaceuticals. Clarification is required
1.5.6 • You have applied for innovator
specifications while the monograph for the
applied product is available in USP. Revise
your specification as per USP monograph
along with submission of applicable fee
1.6.5 • Valid GMP certificate / DML of drug
substance manufacturer for omeprazole and
sodium bicarbonate issued by relevant
regulatory authority of country of origin is
required
2.3.R.1 • Provide copy of Batch Manufacturing
Record (BMR) for all the batches of drug
product for which stability studies data is
3.2.S.4 • Copies of the Drug substance
specifications and analytical procedures
used for routine testing of the Drug
substance /Active Pharmaceutical
Ingredient sodium bicarbonate by Drug
• Copies of the Drug substance analytical
procedures used for routine testing of the
Drug substance /Active Pharmaceutical
Ingredient sodium bicarbonate by Drug
product manufacturer is required.
• Results of specificity test for dug substance
omeprazole is not submitted
• Provide evidence of Atomic Absorption
Spectroscopy used for analysis of calcium,
mg, copper in sodium bicarbonate as per
results given in batch analysis
• The limits of assay test for sodium
bicarbonate in USP is 99-100.5 while drug
substance manufacturer and drug product
manufacture have followed 99-101 in batch
analysis
3.2.S.7 • Submit stability study data of drug
substance omeprazole and sodium
bicarbonate as per zone IV-A conditions
3.2.P.5 • Test for pH is not included in specification
although recommended by USP monograph
• Justification is required since limits of
dissolution specification of applied drug
product (Q 75 in 30 min) is different than
that recommended by innovator product
review document (Q 75 in 15min).
• Justification is required for not included the
limits of sodium bicarbonate in dissolution
test in submitted specifications
• Submit complete analytical procedure for
applied product
• Submit method verification studies for
applied product
3.2.P.8 • Submit documents for the procurement of
API with approval from DRAP.
accelerated)
205. Name, address of Applicant / Marketing M/s Biogen Life Sciences, 8-km Chakbeli Road
Rawat Rawalpindi
☐ Importer
☐ Export sale
Details of fee submitted Not submitted
The proposed proprietary name / brand Fusigen-H 15gm Cream
name
Strength / concentration of drug of Each gram cream contains:
Active Pharmaceutical ingredient (API) Fusidic Acid (BP)……..….20mg (2% w/w)
per unit Hydrocortisone Acetate……10mg (1% w/w)
Pharmaceutical form of applied drug White to off white color cream.
Pharmacotherapeutic Group of (API) Antibiotics & corticosteroid For Topical Use
specifications
The status in reference regulatory Fucidin H cream MHRA approved
authorities
For generic drugs (me-too status) Fusimax-H 2%+1% Cream by M/s Maxitech Pharma
(Reg# 83733)
manufacturer
Name and address of API manufacturer. Fusidic Acid:
Joyang Laboratories., Haidu North Road, Sheyang
Economic Development Zone, Jiangsu, China
Hydrocortisone Succinate:
Henan Lihua Pharmaceutical Co Ltd., Middle of
Huanghe Street, Anyang Hi-Tech Industry
Development Zone, Henan China
structure, general properties, solubilities impurities,
Stability studies Fusidic Acid:
Firm has submitted stability study data of fusidic
acid. Stability study is conducted Real time: 30°C ±
2°C / 65% ± 5%RH for 24 months and at Accelerated
conditions 40°C ± 2°C / 75% ± 5%RH for 6 months
Batches: (121002FA, 121003FA, 121004FA)
Batches: (150501FB, 150502FB, 150503FB)
Hydrocortisone Acetate:
Hydrocortisone acetate. Stability study is conducted
and at Accelerated conditions 40°C ± 2°C / 75% ±
5%RH for 6 months
Batches: (160801, 160802, 160803)
specifications, analytical procedure and its validation
comparative dissolution profile against the brand Genidic-H Cream by performing
quality tests (Identification, Assay, Uniformity of
dosage, pH).
Analytical method validation/verification Method verification studies have submitted including
of product specificity, repeatibility, recovery and accuracy.
Manufacturer of API Fusidic Acid:
Joyang Laboratories., Haidu North Road, Sheyang Economic Development
Zone, Jiangsu, China
Hydrocortisone Succinate:
Henan Lihua Pharmaceutical Co Ltd., Middle of Huanghe Street, Anyang
Hi-Tech Industry Development Zone, Henan China
API Lot No. Fusidic Acid: 200507 FB
Hydrocortisone Acetate: K06M20210604
Description of Pack Cream filled in Aluminium pre-printed tube packed in unit carton
(Container closure
system)
Batch No. T-001 T-002 T-003
Batch Size 500 tubes 500 tubes 500 tubes
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate Fusidic Acid:
of API manufacturer issued by concerned Firm has submitted GMP certificate
regulatory authority of country of origin. No#CQ20180013 in the name of M/s Joyang
Laboratories., Haidu North Road, Sheyang Economic
Development Zone, Jiangsu, China issued by
Chonging Food and Drug administration China valid
upto 06-06-2023
3. Documents for the procurement of API Fusidic Acid:
with approval from DRAP (in case of Firm has submitted copy of invoice No# 00025096
import). dated 02-04-2020 in name of M/s Biogen
Pharmaceuticals for import of 1.5kg of Fusidic Acid.
DRAP Field office.
testing
accelerated)
1.1 • Fee for registration of applied product is
not submitted
1.6.5 • Details of each drug substance
manufacturer should be provided in this
section separately
• Valid GMP certificate / DML of drug
substance manufacturer for hydrocortisone
acetate issued by relevant regulatory
3.2.S.4 • Copies of the Drug substance specifications
and analytical procedures used for routine
Pharmaceutical Ingredient fusidic acid by
Drug product manufacturer is required.
• Copies of the Drug substance specifications
and analytical procedures used for routine
Pharmaceutical Ingredient hydrocortisone
acetate by both drug substance and Drug
product manufacturer is required
• Analytical Method Verification studies
including specificity, accuracy and
repeatability (method precision) performed
by the Drug Product manufacturer for drug
substance(s) i.e. fusidic acid and
hydrocortisone acetate shall be submitted.
3.2.P.2 • Submit details of reference / comparator
product including batch numbers,
manufacturing & expiry date, name of
manufacturer in pharmaceutical
equivalence
• Justify why Pharmaceutical equivalence of
the applied product has not been performed
against the innovator product?
3.2.P.3 • Description of manufacturing process does
not include the step in which the
hydrocortisone is added in the formulation
in manufacturing process, clarification is
required
3.2.P.8 • Documents for procurement of API with
approval from DRAP
accelerated)
206. Name, address of Applicant / Marketing M/s Biogen Life Sciences, 8-km Chakbeli Road
Rawat Rawalpindi
☐ Importer
giver)
☐ Export sale
(Deposit Slip#86318672487)
Fusigen-B Cream
name
Strength / concentration of drug of Active Each tube contains:
Pharmaceutical ingredient (API) per unit Fusidic Acid……..….20mg
Betamethasone (as valerate)……1mg
Pharmaceutical form of applied drug Cream.
Pharmacotherapeutic Group of (API) Antibiotics & corticosteroid For Topical Use
specifications
The status in reference regulatory Fusidic acid/Betamethasone 20 mg/g + 1 mg/g
authorities cream MHRA approved
For generic drugs (me-too status) Fudic-B Cream by M/s Shaigan Pharmaceutical
(Reg# 83599)
manufacturer
Name and address of API manufacturer. Fusidic Acid:
Joyang Laboratories., Haidu North Road,
Sheyang Economic Development Zone, Jiangsu,
China
Betamethasone valerate:
Envee Drugs Pvt. Ltd., N. H. No. 8, Dumral-387
355, Ta. Nadiad, Dist: Kheda, Gujarat, India
structure, general properties, solubilities
impurities, physical form, manufacturers,
drug substance
Stability studies Fusidic Acid:
Firm has submitted stability study data of fusidic
acid. Stability study is conducted Real time:
30°C ± 2°C / 65% ± 5%RH for 24 months and at
Accelerated conditions 40°C ± 2°C / 75% ±
5%RH for 6 months
Batches: (121002FA, 121003FA, 121004FA)
Batches: (150501FB, 150502FB, 150503FB)
Betamethasone Valerate:
Betamethasone Valerate. Stability study is
conducted Real time: 30°C ± 2°C / 65% ± 5%RH
for 48months and at Accelerated conditions 40°C
± 2°C / 75% ± 5%RH for 6 months
Batches: (EV/00808, EV/06308, EV/10507)
controls, specifications, analytical procedure and
drug product.
comparative dissolution profile established against the brand Fuciden cream
Cream by performing quality tests
(Identification, Assay, pH, average weight).
Analytical method validation/verification of Method validation studies have been submitted
product including accuracy, repeatability (method
precision), linearity and range, specificity,
system suitability.
Manufacturer of API Fusidic Acid:
Joyang Laboratories., Haidu North Road, Sheyang Economic
Development Zone, Jiangsu, China
Envee Drugs Pvt. Ltd., N. H. No. 8, Dumral-387 355, Ta. Nadiad, Dist:
Kheda, Gujarat, India
API Lot No. Fusidic Acid: 200507 FB
Betamethasone Valerate: EV/BV-256/20
Description of Pack Cream filled in Aluminium pre-printed tube packed in unit carton
Batch No. T#2004FB T#2005FB T#2006FB
Batch Size 500 tubes 500 tubes 500 tubes
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of Fusidic Acid:
API manufacturer issued by concerned Firm has submitted GMP certificate
regulatory authority of country of origin. No#CQ20180013 in the name of M/s Joyang
Laboratories., Haidu North Road, Sheyang
Economic Development Zone, Jiangsu, China
issued by Chonging Food and Drug
administration China valid upto 06-06-2023
Firm has submitted GMP certificate No#S-GMP
& GLP / 21072790 in the name of Envee Drugs
Pvt. Ltd., N. H. No. 8, Dumral-387 355, Tal.
Nadiad, Dist: Kheda, Gujarat, India issued by
Food and Drugs control administration
Gandinagar, Gujarat State India valid upto 06-07-
2023
3. Documents for the procurement of API with Fusidic Acid:
approval from DRAP (in case of import). Firm has submitted copy of invoice No#
00025096 dated 02-04-2020 in name of M/s
Biogen Pharmaceuticals for import of 1.5kg of
Fusidic Acid. However, the invoice is not
attested by AD (I&E) DRAP Field office.
Firm has submitted copy of invoice No# 93 dated
02-11-2020 in name of M/s Biogen Life sciences
for import of 03kg of Betamethasone valerate.
DRAP Field office.
testing
1.5.2 • Revise label claim as per reference
formulation along with submission of
applicable fee
3.2.S.4 • Copies of the analytical procedures used
for routine testing of the Drug substance
fusidic acid by both drug substance
manufacturer and Drug product
• Copies of the Drug substance
specifications of drug substance fusidic
acid by Drug product manufacturer is
required.
• Copies of the Drug substance
specifications and analytical procedures
used for routine testing of the Drug
substance Betamethasone Valerate by Drug
product manufacturer is required
• Analytical Method Verification studies
by the Drug Product manufacturer for drug
substance(s) i.e. fusidic acid and
betamethasone valerate shall be submitted.
• Certificate of Analysis of the same batch of
fusidic acid used during product
development and stability studies from
Drug Substance manufacturer is required.
3.2.P.2 • Submit details of reference / comparator
product including batch numbers,
manufacturing & expiry date, name of
manufacturer in pharmaceutical
equivalence
3.2.P.6 • Submit readable copy of reference standard
of fusidic acid and betamethasone valerate
3.2.P.8 • Submit stability summary sheet of batch
#2006FB at accelerated conditions
• Documents for procurement of API with
approval from DRAP
accelerated)
Item No. IV Agenda of Evaluator-IV (Mst.Farzana Raja)
Case no. 01 Registration applications for local manufacturing of (Human) drugs on form 5F
a. New cases
207.Name, address of Applicant / Marketing M/s Horizon Healthcare (Pvt.) Ltd.
Authorization Holder Plot no. 33 Sundar Industrial Estate Lahore.
Name, address of Manufacturing site. M/s Horizon Healthcare (Pvt.) Ltd.
Plot no. 33 Sundar Industrial Estate Lahore.
☐ Importer
Status of application ☒New Drug Product (NDP)
☐Generic Drug Product (GDP)
☐ Export sale
☐Domestic and Export sales
Details of fee submitted PKR 75,000/-: Deposit slip # 484307037314
Tofanib XR tablet 11mg
name
Strength / concentration of drug of Each Film coated Modified release tablet contains:
Active Pharmaceutical ingredient (API) Tofacitinib Citrate eq. to Tofacitinib .........11mg
per unit
Pharmaceutical form of applied drug White to off white, oblong shape, film coated
tablets
Pharmacotherapeutic Group of (API) Immunosuppressants
As per innovator
specifications
The status in reference regulatory XELJANZ XR Tablets 11mg approved by US-
authorities FDA
For generic drugs (me-too status) Drug is not available in Pakistan
GMP status of the Finished product Last inspection report dated 18.06.2020 concluded
manufacturer good level of cGMP compliance.
Name and address of API manufacturer. M/s Kaifeng Pharmaceutical (Group) Company,
Ltd.
No.1 Yunan Street, Kaifeng Henan Province, China
structure, general properties, Manufacturers,
Characterization, Impurities, Specifications,
Analytical procedures, Validation of analytical
procedure, batch analysis and justification of
Module III (Drug Substance) The firm as submitted detail of General
information, General properties, Manufacturers,
description of manufacturing process and process
controls, Characterization, Impurities, Control of
drug substance, Reference standard or materials
drug substance.
months
Batch No Accelerated Long
Term
15012401 6 Months 36 Months
Module-III (Drug Product): The firm has submitted detail of Drug Products
including Description and composition of drug
product, Pharmaceutical Development,
Manufacturing process development,
Microbiological attribution, Manufacturer, Master
formulations, Description of Manufacturing
Process and Process Controls, Control of Critical
Steps and Intermediates, Process Validation and/ or
Evaluation, Control of Excipients with
specification and Analytical methods, Control of
Drug Products including Finished product
specifications and test methods, validation of
Analytical methods, Batch analysis ,
Characterization of impurities, reference standard
or impurities, Container closure and stabilities
studies.
comparative dissolution profile against the brand leader that is Xeljanz XR 11mg
Tablets approved by US-FDA by performing
quality tests (Identification, Assay, and
Dissolution. CDP has been performed against the
same brand that is Xeljanz Tablets 11mg approved
by US-FDA in Acid media (pH 1.2) , Acetate
Buffer (pH 4.5) & Phosphate Buffer (pH 6.8)
of product including Introduction, Verification of assay
method, Specificity, Accuracy, Precision, Linearity
concentration and peak range.
Manufacturer of API M/s Kaifeng Pharmaceutical (Group) Company, Ltd.
No.1 Yunan Street, Kaifeng Henan Province, China
API Lot No. HF210605
Description of Pack Alu-Alu. Blisters with aluminum foil having leaflet and packed in unit carton
(Container closure
system)
Batch No. TC-001 TC-002 TC-003
No. of Batches 03
applications with stability study data of product EMPAZON 10mg Tablets, EMPAZON
the firm (if any) 25mg Tablets (Empagliflozin) and Dayzol 30mg
Capsules, Dayzol 60mg Capsules
(Dexlansoprazole)
which was conducted on 1st June, 2021 and was
presented in 307th meeting of Registration Board
held on 08-10th June , 2021.
.
According to the report following points were
confirmed.
• The firm has 21 CFR compliant HPLC
software
• The firm has audit trail reports available.
• The firm possesses stability chambers with
digital data loggers
2. Approval of API/ DML/GMP certificate Copy of GMP certificate No. HA20190069 issued
of API manufacturer issued by concerned by NMPA valid till 28-09-2024
regulatory authority of country of origin. Copy of DML No. Yu20150031 issued by NMPA
valid till 31-12-2025
3. Documents for the procurement of API Firm has submitted copy of form 3, form 7 , invoice
with approval from DRAP (in case of (invoice# CIN20210701L01) dated 01-07-2021
import). cleared by DRAP Lahore office dated 19-07-2021
specifying import of Tofacitinib Citrate 0.25kgs
(Batch# HF210605).
chromatograms,
sheets etc.
5. Compliance Record of HPLC software Audit trail reports have been submitted.
testing
stability chambers (real time and chambers.
accelerated)
S.N Section Shortcomings Reply
o Communicated
1. 2.3.A.1 Evidence of manufacturing Firm submitted invoice for purchase of Laser
facility with laser drill Drilling Machine for tablet from Nimbus
chemtech Invoice No# NC/029-21 Dated:
15-05-2021
2. 3.2.S.4.2 In standard preparation • The Standard analytical procedure of
and Sample solution Tofacitinib citrate was followed by Drug
Quantity of Tofacitinib substance procedure provided by the
Citrate is written as manufacturer. The proper quantity is
proper quantity. Clarify taken: for standard and sample the final
what is proper quantity.
concentration is mentioned as 80 µg/mL
respectively. The standard and sample
quantity taken accordingly
Standard Stock Solution:
20mg of Working Standard (Tofacitinib
Citrate) into 25ml of diluent (0.8mg/mL
or 800µg/mL)
Standard Solution:
5mL from standard stock solution into
50ml diluent (0.08mg/mL or 80µg/mL)
Sample Stock Solution:
20mg of Tofacitinib Citrate Sample into
Sample Solution:
5mL from sample stock solution into
3. 3.2.S.4.3 • In standard preparation • The Standard analytical procedure of
and Sample solution Tofacitinib citrate was followed by Drug
Quantity of Tofacitinib substance procedure provided by the
Citrate is written as manufacturer. The proper quantity is
proper quantity. taken: for standard and sample the final
Clarify what is proper concentration is mentioned as 80 µg/mL
quantity. respectively. The standard and sample
• In specificity quantity taken accordingly
Bempedoic acid
Standard Stock Solution:
sample mentioned. 20mg of Working Standard (Tofacitinib
Citrate) into 25ml of diluent (0.8mg/mL
or 800µg/mL)
Standard Solution:
5mL from standard stock solution into
Sample Stock Solution:
20mg of Tofacitinib Citrate Sample into
Sample Solution:
5mL from sample stock solution into
50ml diluent (0.08mg/mL or 80µg/mL).
• In method of verification report under
heading of specificity the Bempedoic acid
was written it is typographical mistake.
Decision: Approved.
208.Name, address of Applicant / Marketing M/s Getz Pharma (Pvt.) Limited
Authorization Holder 29-30/27, Korangi Industrial Area, Karachi.
Name, address of Manufacturing site. M/s Getz Pharma (Pvt.) Limited
29-30/27, Korangi Industrial Area, Karachi.
☐ Importer
☐ Export sale
URSOVA Tablets 500mg
name
Strength / concentration of drug of Each film-coated tablet contains:
Active Pharmaceutical ingredient (API) Ursodeoxycholic Acid (Ursodiol) …500mg
per unit
Pharmaceutical form of applied drug Red colored, oblong shaped, biconvex film- coated
tablet, bisect line on one side and plain on other
side.
Pharmacotherapeutic Group of (API) Bile acids and derivatives
USP Specs.
specifications
Proposed unit price Rs. 750/- (10’s)
The status in reference regulatory URSO Forte Tablets 500mg by M/s Allergan USA
authorities Inc., USA. USFDA Approved.
For generic drugs (me-too status) Not Applicable
GMP status of the Finished product Last GMP Inspection dated 03-12-2021 concludes
manufacturer that M/s Getz Pharma Pvt. Ltd. is considered to be
operating at an acceptable level of compliance of
GMP requirements. Tablet (General & General
Antibiotic) section approved.
Name and address of API manufacturer. Zhejiang Warrant Pharmaceutical Co., Ltd.
Workshop 1 , No. 4290, Xingbin Road, Binhai
Industrial Zone, Keqiao District, Shaoxing,
Zhejiang, P.R. China.
solubility’s, physical form, manufacturers,
Module III (Drug Substance) Official monograph of Ursodeoxycholic Acid
(Ursodiol) is present in EP pharmacopeia. The firm
has submitted detail of nomenclature, structure,
general properties, solubility’s, physical form,
process and controls, tests for impurities,
months
Batches: (UDCA-II-20191101, UDCA-II-
20191108, UDCA-II-20191202)
drug product.
comparative dissolution profile against the comparator brand that is Ursofalk
Tablet 500mg by M/s Losan Pharma GmbH,
Germany by performing quality tests (Appearance,
Average Weight, Assay, Dissolution).
CDP has been performed against the compator
brand that is Ursofalk Tablet 500mg by M/s
Losan Pharma GmbH, Germany in Acidic media
Buffer (pH 6.8). The f2 values are in the
acceptable range.
Analytical method validation/verification Method Verification studies have submitted
of product including system suitability, linearity, range,
accuracy, precision, specificity and stability of
solution.
Manufacturer of API Zhejiang Warrant Pharmaceutical Co., Ltd.
Workshop 1 No. 4290, Xingbin Road, Binhai Industrial Zone, Keqiao
District, Shaoxing, Zhejiang, P.R. China.
API Lot No. UDCA-II-20191218 (CA20191218)
Description of Pack
(Container closure Alu-PVDC blister packed in unit carton (10’s)
system)
Batch No. 539DS01 539DS02 539DS03
Manufacturing Date 09.06.2020 29.06.2020 29.06.2020
Date of Initiation 21.07.2020 21.07.2020 21.07.2020
No. of Batches 03
applications with stability study data of product Estine (Ebastine) tablets 10mg & 20mg
the firm (if any) which was conducted on 06th May 2019 and was
held on 14th -16th May 2019. The case was approved
and the inspection report confirms following points:
• Adequate monitoring and control are available
for stability chamber. Chambers are controlled
and monitored through software having alarm
system for alerts as well.
• Related manufacturing area, equipment,
personnel and utilities are GMP compliant.
2. Approval of API/ DML/GMP certificate Copy of Drug Manufacturing License no. Zhe
of API manufacturer issued by concerned 20070479 issued by Zhejiang Provincial Drug
regulatory authority of country of origin. Administration valid till 11-05-2026.
3. Documents for the procurement of API Firm has submitted copy of, invoice (invoice#
with approval from DRAP (in case of 20ATGZ046) dated 02-04-2020 cleared by DRAP
import). Karachi office dated 14-04-2020 specifying import
of Ursodeoxycholic Acid 7.50Kg (Batch#
CA20191218s).
chromatograms,
sheets etc.
testing
accelerated)
o Communicated
1. 3.2.S.4.3 Analytical Method Analytical Method Verification studies
Verification studies including specificity, linearity, repeatability
including specificity, and range performed by the Drug Product
accuracy and repeatability manufacturer are attached.
(method precision)
performed by the Drug Further, with reference to ICH Guidelines
Product manufacturer for “VALIDATION OF ANALYTICAL
drug substance(s) shall be PROCEDURES: TEXT AND
submitted METHODOLOGY Q2 (R1)” it is mentioned
in section 4.1.1 Drug Substance “accuracy
may be inferred once precision, linearity and
specificity have been established”.
This is bring to your kind attention that since

we have performed method verification
studies as per ICH Q2 (R1) therefore,
requirement of accuracy is not applicable.
Link of ICH guideline is provided below:
Q2(R1) Guideline.pdf (ich.org)
2. 3.2.P.5.2 Provide Evidence of Instrument Calibration certificate as an
HPLC with RI detector. evidence of HPLC with RI detector
submitted.
Decision: Approved.
209.Name, address of Applicant / Marketing M/S Welmark pharmaceuticals
Authorization Holder Industrial estate Hattar, Kpk Pakistan
Name, address of Manufacturing site. M/S Welmark pharmaceuticals
Plot No 122 Block-B phase-5 Industrial estate
Hattar Kpk Pakistan
☐ Importer
giver)
☐ Export sale
Details of fee submitted PKR 20,000/-: Dated: 26-01-2021 Deposit slip #
1985094
The proposed proprietary name / brand Teno 25mg Tablet
name
Active Pharmaceutical ingredient (API) Tenofovir Alafenamide Fumarate eq to
per unit Tenofovir Alafenamide………25mg
Pharmaceutical form of applied drug Brown red color 8mm round shaped bisected one
side and other plain film coated tablet.
Pharmacotherapeutic Group of (API) Antiviral for systemic use, nucleoside and
nucleotide reverse transcriptase inhibitors.
Reference to Finished product Manufacturer specifications
specifications
The status in reference regulatory Vemlidy Tablet 25mg by Gilead Sciences Ltd.
authorities U.S.A.., USFDA Approved.
For generic drugs (me-too status) Tenofomide Tablet 25mg by M/s. Getz pharma .,
Reg. No. 093109
GMP status of the Finished product Not submitted.
manufacturer
Name and address of API manufacturer. Shandong Haiyo Freda Pharmaceutical Co Ltd
Address: 666 Bianhai West Road Linshu West
Industrial Zone, Shandong Province.
solubility’s,, physical form, manufacturers,
and its validation, batch analysis and justification
Module III (Drug Substance) Monograph of Tenofovir Alafenamide Fumarate is
present is as per In-house (Manufacturer’s)
specifications. The firm as submitted detail of
tests for related substances (Impurity A, PMPA,
Unspecified impurity and Total impurities),
months
Batches: (180702, 180713, 180725)
medium) and its validation studies, batch analysis
comparative dissolution profile equivalence for all the quality tests for their
product against Tenofomide 25mg Tablets (Batch
No. 004FB1, Mfg date 04-2020) by Getz
Pharmaceuticals Karachi.
Firm has submitted results of CDP for their
product against Tenofomide 25mg Tablets (Batch
No. 004FB1, Mfg date 04-2020).
Firm has tested CDP in three dissolution medium
ie. (0.1N Hcl pH 1.2, Acetate Buffer pH 4.5,
Phosphate Buffer pH 6.8 and the results of f1, f2
factor are within the acceptable limit.
Analytical method validation/verification Method validation studies have submitted
specificity.
Manufacturer of API Shandong Haiyo Freda Pharmaceutical Co Ltd
Address: 666 Bianhai West Road Linshu West Industrial Zone, Shandong
Province.
Description of Pack 30’s Tablets Teno 25mg Tablets will be packed in jar and Secondary
(Container closure Packing in Unit Carton.
system)
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate Copy of GMP certificate No. SD20160495 issued
of API manufacturer issued by concerned by NMPA valid till 08-08-2021.
3. Documents for the procurement of API Firm has submitted copy of form 3, form 7 ,
with approval from DRAP (in case of invoice (invoice# JNXKYY20030302) dated 03-
import). 03-2020 specifying import of Tenofovir
Alafenamide Fumarate 2 Kg (Batch# 20021701).
But Not attested.
chromatograms,
sheets etc.
testing
accelerated)
Remarks OF Evaluator:
o Communicated
1. 1.1 Differential fee of Rs: Fee of Rs: 10000/- Deposit slip
10000/- #0874644724055 submitted.
2. 1.3.5. GMP inspection report/ Not submitted.
GMP certificate of the
manufacturing unit issued
within the last three years
shall be submitted.
3. 1.6.5 • Drug substance • The drug substance manufacturer is
manufacturer Shandong Haiyo Freda
mentioned in this Pharmaceuticals Co Ltd. Documents
section is M/s Jinan submitted
Xinke Pharmaceuticals
Sci & Tech. C0., Ltd , . • Submitted GMP certificate is valid
While certificate of upto 08-08-2021
analysis an import (Submitted again same GMP
documents are from certificate which is not valid)
Shandong Haiyo Freda
Pharmaceutical Co Ltd
. Clarification is
required amongst them
which one is drug
substance
manufacturer.
• Valid Drug
Manufacturing License
issued by the relevant
regulatory authority of
country of origin. Or
Valid Good
Manufacturing
Practice (GMP)
certificate of the Drug
Substance
manufacturer issued by
relevant regulatory
authority of country of
origin.
4. 3.2.S.4.1 Copies of the Drug Submitted
substance Specifications
by Drug Product
5. 3.2.S.4.2 Detailed analytical Submitted
procedures used for
routine testing of the Drug
manufacturer shall be
provided.
6. 3.2.S.4.3 Analytical Method Submitted
Verification studies
including specificity,
accuracy and repeatability
(method precision)
performed by the Drug
Product manufacturer for
drug substance(s) shall be
submitted.
7. 3.2.S.5 COA of primary / Submitted
secondary reference
standard including source
and lot number shall be
provided.
8. 3.2.P.2.3 Manufacturing process by We are following innovators
Innovator is dry manufacturing process and our method is
granulation while your dry granulation.
method is Wet granulation.
Clarify.
9. 3.2.P.5.1 US FDA review document That was a typographic mistake, we are
of the Innovator product, following innovators specification and
specifies the dissolution dissolution limit is NLT Q in 15 minutes.
limit as “NLT Q in 15
minutes” whereas
submitted specifications
declare the dissolution
limits as “NLT 75% in 30
minutes” .
10. 3.2.P.5.2 Submit complete Submitted
analytical method for
testing of drug product.
11. • Documents for the • Not Submitted
procurement of API • We are following innovator
with approval from specifications i.e. dissolution limit is
DRAP. NLT Q in 15 minutes in 50mM
• US FDA review Sodium Acetate buffer pH 4.5.
document of the • Compliance record of HPLC software
Innovator product, 21CFR & audit trail reports on
product testing submitted.
specifies the
dissolution limit as
“NLT Q in 15
minutes” in 50mM
Sodium Acetate buffer
pH 4.5. whereas
submitted
specifications declare
the dissolution limits
as “NLT 75% in 30
minutes with
Phosphate Buffer pH
6.8”.
• Compliance Record of
HPLC software 21CFR
& audit trail reports on
product testing
• Record of Digital data
logger for temperature
and humidity
monitoring of stability
chambers (real time
and accelerated)
• Valid Drug Manufacturing License issued by the relevant regulatory authority of
country of origin or Valid Good Manufacturing Practice (GMP) certificate of the Drug
Substance manufacturer issued by relevant regulatory authority of country of origin.
• Documents for the procurement of API with approval from DRAP.
• Analytical record for the dissolution test for stability studies as per Innovator product.
210.Name, address of Applicant / Marketing M/s Medisure Laboratories Pakistan Private
Authorization Holder Limited at A-115, S.I.T.E., Super Highway,
Karachi Pakistan
Name, address of Manufacturing site. M/s Medisure Laboratories Pakistan Private
Limited.
Plot A-115, S.I.T.E., Super Highway, Karachi
Pakistan
Status of the applicant ☑Manufacturer
☒ Importer
☒ Is involved in none of the above (contract giver)
☑ Generic Drug Product (GDP)
☒ Export sale
☑Domestic and Export sales
Tenosure 25mg Tablet
name
Active Pharmaceutical ingredient (API) Tenofovir Alafenamide ----------25 mg
per unit (as Tenofovir Alafenamide Fumarate)
Pharmaceutical form of applied drug Light orange colored, round, biconvex, film
coated tablet both sides are plain.
Pharmacotherapeutic Group of (API) Nucleoside analog reverse transcriptase inhibitor
Manufacturer Specification
specifications
Proposed Pack size 1x 30’s
Proposed unit price As per SRO (not allotted yet)
The status in reference regulatory Vemlidy Tablet 25mg by Gilead Sciences Ltd.
authorities U.S.A.., USFDA Approved.
For generic drugs (me-too status) Tefod Tablet 25mg by M/s. Sami Pharmaceuticals
(Pvt.) Ltd., Reg. No. 096182
GMP status of the Finished product Last inspection report on the basis of inspection
manufacturer conducted 07-09-2021 states that their current
GMP compliance level is rated as Good.
Name and address of API manufacturer. Lianyungang Jari Pharmaceuticals Co. Ltd.
Address: No. 18 Zhenhua Road, Lianyungang
City, Jiangsu Province, China
Module III (Drug Substance) Official monograph of Tenofovir Alafenamide
Fumarate is not present in any pharmacopeia. The
firm as submitted detail of nomenclature, structure,
general properties, solubility’s,, physical form,
process and controls, analytical procedures and its
months
(20171015, 20171115, 20171215)
specifications, analytical procedure (including
dissolution testing at acidic and buffer medium)
and its verification studies, batch analysis and
drug product.
comparative dissolution profile against the brand leader that is Tenofomide Tablet
25mg by M/s. Getz pharma by performing quality
tests (Identification, Disintegration, Assay,
Dissolution,).
that is Tenofomide Tablet 25mg by M/s. Getz
pharma in Acid media (pH 1.0-1.2) & Phosphate
Buffer (pH 6.8). The values for f1 and f2 are in the
acceptable range.
Analytical method validation/verification Method Validation studies have submitted
of product including linearity, range, accuracy, precision, and
specificity.
Manufacturer of API Lianyungang Jari Pharmaceuticals Co. Ltd.
Address: No. 18 Zhenhua Road, Lianyungang City, Jiangsu Province, China
API Lot No.
Description of Pack
30 tablets are packaged in high density polyethylene (HDPE) bottles
(Container closure
in unit carton (1×30’s)
system)
Real Time: 0, 3, 6 ,9,12 (Months)
Batch No. T-001 T-002 T-003
Batch Size 0.73Kg 0.73Kg 0.73Kg
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate Copy of GMP certificate No. JS20191190 issued by
of API manufacturer issued by concerned National Medical products Administration valid till
regulatory authority of country of origin. 29/11/2024
3. Documents for the procurement of API Firm has submitted copy of invoice (MP-2020-
with approval from DRAP (in case of AUG-003) dated 10-09-2020 cleared by DRAP
import). Karachi office dated 28-09-2020 specifying import
of Tenofovir Alafenamide Fumarate 1.5 Kg
chromatograms,
sheets etc.
testing
accelerated)
o Communicated
1. 1.3.5. GMP inspection report/ Last inspection report on the basis of
GMP certificate of the inspection conducted 07-09-2021 states that
manufacturing unit issued their current GMP compliance level is rated
within the last three years as Good.
shall be submitted.
2. 2.3.R.1.1 Justify the quantity of Factor applied is 1.243 so the quantity
Tenofovir Alafenamide each tablet contains 31mg of Tenofovir
each tablet contains with Alafenamide Fumarate
equivalency factor of
fumarate. (While actual factor is 1.122 so quantity of
Each tablet contains 28 mg of Tenofovir
Alafenamide Fumarate eq to 25mg of
Tenofovir Alafenamide
Molecular weight of
Tenofovir Alafenamide Fumarate:534.50
Tenofovir Alafenamide: 476.466)
3. 3.2.S.4.1 Copies of the Drug Submitted
substance Specifications
by Drug Product
4. 3.2.S.4.2 Detailed analytical Submitted.
procedures used for
routine testing of the Drug
manufacturer shall be
provided.
5. 3.2.S.4.3 Analytical Method Not submitted.
(method precision)
drug substance(s) shall be
submitted.
6. 3.2.S.4.4 Certificate of analysis of Not submitted.
drug substance provided
by drug Product
manufacture and drug
substance manufacturer
are of different supplier
than applied in module I.
Clarification is required.
7. 3.2.S.5 COA of primary / Submitted
secondary reference
and lot number shall be
provided.
8. 3.2.P.1 Justify the quantity of Not submitted
Tenofovir Alafenamide
each tablet contains with
equivalency factor of
fumarate.
9. 3.2.P.5.2 Justify dissolution Instead of reply firm Refer to CDP.
acceptance criteria NLT
80% in 45 min with
dissolution medium 0.1N
hydrochloric acid pH 1.2
while dissolution
specifications of innovator
is NLT Q in 15 min with
dissolution medium 50
mM Sodium Acetate
buffer pH 4.5
10. 3.2.P.8 • Documents for the • Submitted.
procurement of • 5214 Tablet in one batch
API with approval
from DRAP
• Specify batch size
in No of units/
Tablets
• Analytical Method Verification studies including specificity, accuracy and repeatability
(method precision) performed by the Drug Product manufacturer for drug substance(s)
shall be submitted.
• Certificate of analysis of drug substance provided by drug Product manufacture and
drug substance manufacturer are of different supplier than applied in module I.
• Justify the quantity of Tenofovir Alafenamide each tablet contains with equivalency
factor of fumarate.
• Justify dissolution acceptance criteria NLT 80% in 45 min with dissolution medium 0.1N
hydrochloric acid pH 1.2 while dissolution specifications of innovator is NLT Q in 15
min with dissolution medium 50 mM Sodium Acetate buffer pH 4.5
b. Deferred Cases:
211. Name, address of Applicant / Marketing M/s Citi Pharma Private Limited
Authorization Holder
Name, address of Manufacturing site. M/s Citi Pharma Private Limited
Factory: 3 K.M, Head Balloki Road, Phool
Nagar, Distt. Kasur
☐ Importer
☐ Export sale
Panadol Extra Tablets
name
Strength / concentration of drug of Each tablet contains:
Active Pharmaceutical ingredient (API) Paracetamol……. 500mg
per unit Caffeine….. 65mg
Pharmaceutical form of applied drug Oral (Tablet)
Pharmacotherapeutic Group of (API) Analgesics and Psychoactive drug.
USP
specifications
Proposed Pack size 10x10’s tablets
The status in reference regulatory Panadol Extra by GSK (GlaxosmithKline), UK
authorities Approved in UK.
For generic drugs (me-too status) Panadol Extra GSK (GlaxosmithKline). Pakistan
GMP status of the Finished product cGMP certificate on the basis of evaluation
manufacturer conducted on 19-03-2019
Name and address of API manufacturer. Paracetamol: Citi Pharma Pvt Ltd
3.5-Km, Head Balloki Road, Phool Nagar Kasur-
Pakistan.
Caffeine: Aarti Industries Limited
1. Plot No D-53, phase II, M.I.D.C
Kalyanshil RD Dombival (East) Thane 421204
Maharashtra state, India.
2. K-17/18/19, M.I.D.C, tararpur, Distict,
Thane zone 4.
Module III (Drug Substance) Official monograph of Paracetamol and
Caffeine is present in BP. The firm as submitted
detail of nomenclature, structure, general
properties, solubility’s, physical form,
substance
Paracetamol: Real time: 30°C ± 2°C / 65% ±
5%RH for 60 months
months
Batches: (PGP14-37, PGP14-38, PGP14-39)
Caffeine: Real time: 30°C ± 2°C / 65% ± 5%RH
for 60 months
months
Batches: (C-3011 C-3076, C-3115)
comparative dissolution profile established against the brand leader that is Panadol
Extra Tablets by M/s GSK (GlaxosmithKline).
Pakistan performing quality tests (Identification,
Weight variation, Disintegration, Assay,
Dissolution).
that is Panadol Extra Tablets by M/s GSK
(GlaxosmithKline). Pakistan in Acid media (pH-
1.2),Acetate Buffer(pH-4.5) & Phosphate Buffer
(pH 6.8)..
Analytical method
Manufacturer of API Paracetamol: M/s Citi Pharma Private Limited Lahore.
API Lot No. Caffeine:
Paracetamol: PGP21-183
Description of Pack
10X10’s Blistered in ALU-PVC packed in standard unit carton
(Container closure
provided with leaflet inside.
system)
Batch No. TRA-PE001 TRA-PE002 TRA-PE003
Batch Size 10,000 Tablets 10,000 Tablets 10,000 Tablets
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate Paracetamol: Copy of cGMP certificate on the
of API manufacturer issued by basis of evaluation conducted on 17-12-2020 and
concerned regulatory authority of valid for 2 years
country of origin. Caffeine: Copy of GMP certificate No. 6101335
for Aarti Industries Limited (K-17/18/19,
M.I.D.C, tararpur, Distict, Thane zone 4) issued
by Food and Drug Administration Mahrashtra
India-valid for 12-08-2022
3. Documents for the procurement of API Paracetamol: Purchase documents Invoice No#
with approval from DRAP (in case of F20-34 Dated: 11-08-2021 of Batch No # PGP21-
import). 513.
Caffeine: Form 6 for Caffeine submitted of dated:
15-07-21 by Lahore office
sheets etc.
testing
6. Record of Digital data logger for
accelerated)
Remarks OF Evaluator: Firm submitted NOC as follows:
M/s GlaxoSmithKline Consumer health Pakistan Limited 35-Dockyard Road, West Whraf –Karachi-
Pakistan has provided no objection certificate for utilization of Panadol brand name as under :-
“We, owners of the “Panadol” brand name since may decades globally and in Pakistan for
last 45 years, would like to manufacture our following products at “Citi Pharma Private
Limited” under the DRAP’s Contract manufacturing policy:
S.No. Brand Name
1. Panadol Extra Tablets
2. Panadol Migraine tablets
3. Panadol Muscle Relaxant tablets
Further to this, Please note that we have no objection to the use of the brand Name
“Panadol” for the aforementioned products, applied by Citi Pharma for the registration on
contract manufacturing on behalf of GlaxoSmithKline consumer Healthcare Limited
Pakistan.”
Remarks of Evaluator: Firm submitted NOC as follows:
M/s GlaxoSmithKline Consumer health Pakistan Limited 35-Dockyard Road, West Whraf –
Karachi-Pakistan has provided no objection certificate for utilization of Panadol brand name as
under :-
S.No. Brand Name
Further to this, Please note that we have no objection to the use of the brand Name
“Panadol” for the aforementioned products, applied by Citi Pharma for the registration
on contract manufacturing on behalf of GlaxoSmithKline consumer Healthcare Limited
Pakistan.”
S.No Section Shortcomings Communicated

1. 1.6.5 Submitted GMP certificate of different site than documents submitted for
drug substance (Caffeine)
2. 2.3.R.1.1 Provide copy of Batch Manufacturing Record (BMR) for all the batches
of drug product for which stability studies data is provided in Module 3
section 3.2.P.8.3
3. 3.2.S.4.1 Copies of the Drug substance specifications and analytical procedures
used for routine testing of the Drug substance /Active
(Caffeine)Pharmaceutical Ingredient by Drug Product manufacturer is
required.
4. 3.2.S.4.3 Analytical Method Verification studies including specificity, accuracy
and repeatability (method precision) performed by the Drug Product
manufacturer for drug substance(s) (Paracetamol and Caffeine)shall be
submitted.
5. 3.2.S.4.4 Provide results of analysis of relevant batch(es) of Drug Substance
performed by Drug Product manufacturer used during product
development and stability studies, along with Certificate of Analysis
(CoA) of the same batch from Drug Substance / Active Pharmaceutical
Ingredient (Paracetamol and Caffeine) manufacture.
6. 3.2.S.5 COA of primary / secondary reference standard including source and lot
number for Caffeine shall be provided.
7. 3.2.P.2.2.1 • 6 units are used for CDP. Clarification is required in the light of FDA
guidance for industry and EMA guidelines of Comparative
dissolution.
• F2 calculations for paracetamol and caffeine not submitted.
8. 3.2.P.3.5 Submitted Process validation protocol are general not product related.
9. 3.2.P.5.1 • Specification claimed are USP while in section 1.5.6 applied as B.P.
• Justify your acceptance criteria for dissolution test as NLT 75% after
60 minutes of the labeled amount of paracetamol and caffeine while
USP has specified as NLT 75% (Q) of the labelled amounts of
acetaminophen and caffeine is dissolved.
10. 3.2.P.5.3 Analytical Method Verification studies performed by the Drug Product
manufacturer for drug product shall be submitted.
11. 3.2.P.8 • Stability studies of three (03) months submitted.
• Documents for the procurement of API (Caffeine) with approval
from DRAP Compliance Record of HPLC software 21CFR & audit
trail reports on product testing.
• Record of Digital data logger for temperature and humidity
monitoring of stability chambers (real time and accelerated)
Previous Decision (M-321): Deferred for following:

• Submitted GMP certificate of different site than documents submitted for drug
substance (Caffeine)
• Provide copy of Batch Manufacturing Record (BMR) for all the batches of drug
product for which stability studies data is provided in Module 3 section 3.2.P.8.3
• Copies of the Drug substance specifications and analytical procedures used for routine
testing of the Drug substance /Active (Caffeine) Pharmaceutical Ingredient by Drug
Product manufacturer is required.
•Analytical Method Verification studies including specificity, accuracy and repeatability
(Paracetamol and Caffeine) shall be submitted.
• Provide results of analysis of relevant batch(es) of Drug Substance performed by Drug
Product manufacturer used during product development and stability studies, along with
Certificate of Analysis (CoA) of the same batch from Drug Substance / Active
Pharmaceutical Ingredient (Paracetamol and Caffeine) manufacture.
• COA of primary / secondary reference standard including source and lot number for
Caffeine shall be provided.
• 6 units are used for CDP. Clarification is required in the light of FDA guidance for
industry and EMA guidelines of Comparative dissolution.
• F2 calculations for paracetamol and caffeine not submitted.
• Submitted Process validation protocol are general not product related. Clarification is
required.
• Specification claimed are USP while in section 1.5.6 applied as B.P. Clarification is
required.
• Justify your acceptance criteria for dissolution test as NLT 75% after 60 minutes of the
labeled amount of paracetamol and caffeine while USP has specified as NLT 75% (Q)
of the labelled amounts of acetaminophen and caffeine is dissolved.
• Analytical Method Verification studies performed by the Drug Product manufacturer
for drug product shall be submitted.
• Stability studies of three (03) months submitted.
• Documents for the procurement of API (Caffeine) with approval from DRAP
Compliance Record of HPLC software 21CFR & audit trail reports on product testing.
• Record of Digital data logger for temperature and humidity monitoring of stability
Reply
S.No Section Shortcomings Communicated Reply
1. 1.6.5 Submitted GMP certificate of Firm submitted now GMP certificate
different site than documents # 6101335 valid upto 12-08-2022 of
submitted for drug substance Aarti Industries Limited
(Caffeine) Address: K-17/18/19, M.I.D.C,
tararpur, Distict, Thane zone 4.(
mentioned on all documents)
2. 2.3.R.1.1 Provide copy of Batch Batch Manufacturing Record (BMR)
Manufacturing Record (BMR) for all the batches of drug product for
for all the batches of drug which stability studies data is
product for which stability provided in Module 3 section
studies data is provided in 3.2.P.8.3 submitted
Module 3 section 3.2.P.8.3
3. 3.2.S.4.1 Copies of the Drug substance Copies of the Drug substance
specifications and analytical specifications and analytical
procedures used for routine procedures used for routine testing of
testing of the Drug substance the Drug substance /Active
/Active Pharmaceutical Pharmaceutical Ingredient (Caffeine)
Ingredient (Caffeine) by Drug by Drug Product manufacturer is
Product manufacturer is submitted.
required.
4. 3.2.S.4.3 Analytical Method Verification Analytical method verification of
studies including specificity, tablet (Drug Product) submitted
accuracy and repeatability instead of drug substance.
(method precision) performed by
the Drug Product manufacturer
for drug substance(s)
(Paracetamol and Caffeine)shall
be submitted.
5. 3.2.S.4.4 Provide results of analysis of COA of paracetamol submitted
relevant batch(es) of Drug while, COA of drug substance for
Substance performed by Drug Caffeine of a different Drug
Product manufacturer used substance supplier (Kores India
during product development and limited submitted.
stability studies, along with
Certificate of Analysis (CoA) of
the same batch from Drug
Substance / Active
Pharmaceutical Ingredient
(Paracetamol and Caffeine)
manufacture.
6. 3.2.S.5 COA of primary / secondary Submitted.
Caffeine shall be provided.
7. 3.2.P.2.2.1 • 6 units are used for CDP. • No reply about 6 units used by
Clarification is required in firm
the light of FDA guidance • F2 calculations submitted but
for industry and EMA now data is different from
guidelines of Comparative previous submitted data.
dissolution.
• F2 calculations for
paracetamol and caffeine not
submitted.
8. 3.2.P.3.5 Submitted Process validation Submitted.
protocol are general not product
related. Clarification is required.
9. 3.2.P.5.1 • Specification claimed are • Typographical error. USP
USP while in section 1.5.6 specifications are applied.
applied as B.P. Clarification Rectified and correction has been
is required. made. Revised documents
• Justify your acceptance submitted.
criteria for dissolution test as • No reply of dissolution
NLT 75% after 60 minutes of specifications.
the labeled amount of
paracetamol and caffeine
while USP has specified as
NLT 75% (Q) of the labelled
amounts of acetaminophen
and caffeine is dissolved.
10. 3.2.P.5.3 Analytical Method Verification No reply
studies performed by the Drug
Product manufacturer for drug
11. 3.2.P.8 • Stability studies of three (03) • Stability studies summary
months submitted. sheets of 6 months submitted.
• Documents for the • Import documents Not
procurement of API Submitted.
(Caffeine) with approval • Submitted
from DRAP • Submitted
• Compliance Record of HPLC
• Record of Digital data logger
accelerated)
(Paracetamol and Caffeine) shall be submitted.
• Performance of CDP studies using 12 units each of sample and reference product.
• Justify your acceptance criteria for dissolution test as NLT 75% after 60 minutes of the
labeled amount of paracetamol and caffeine while USP has specified as NLT 75% (Q) of
the labelled amounts of acetaminophen and caffeine is dissolved.
• Documents for the procurement of API (Caffeine) with approval from DRAP.
• Since the submitted dossier does not reflect any details for contract manufacturing while
annexed NOC from M/s GlaxoSmithKline Consumer Health declare it by way of cntract
manufacturing hence firm shall submit clarity regarding the status of registration
application whether it’s for self-manufacturing with registration in name of M/s Citi
Pharma Private Limited or for contract manufacturing with registration in name of M/s
GlaxoSmithKline Consumer health Pakistan Limited. In case of contract manufacturing
for M/s GlaxoSmithKline Consumer health Pakistan Limited, the application shall be re
submitted as per relevant SRO of contract manufacturing policy.
• Clarification for using of Panadol brand name as per Rule 20A of Drugs (L,R &A) Rules,
1976.
212. Name, address of Applicant / Marketing M/s Citi Pharma Private Limited
Name, address of Manufacturing site. M/s Citi Pharma Private Limited Factory: 3 K.M,
Head Balloki Road, Phool Nagar, Distt. Kasur
☐ Importer
☐ Export sale
Panadol Migraine Tablets
name
Active Pharmaceutical ingredient (API) Paracetamol……. 250mg
per unit Caffeine anhydrous….. 65mg
Aspirin…… 250mg
Pharmaceutical form of applied drug Oral (Tablet)
Pharmacotherapeutic Group of (API) NSAID and Psychoactive drug.
USP
specifications
Proposed Pack size 4 X6’s
The status in reference regulatory EXCEDRIN (MIGRAINE)
authorities by M/s GSK (GlaxosmithKline) Consumer
Health, USA, Approved in USA. (OTC product)
For generic drugs (me-too status) ….
GMP status of the Finished product cGMP certificate on the basis of evaluation
manufacturer conductd on 19-03-2019
Name and address of API manufacturer. Paracetamol: Citi Pharma Pvt Ltd
3.5-Km, Head Balloki Road, Phool Nagar Kasur-
Pakistan.
1. Plot No D-53, phase II, M.I.D.C
Kalyanshil RD Dombival (East) Thane 421204
Maharashtra state, India.
2. K-17/18/19, M.I.D.C, tararpur, Distict,
Thane.
Aspirin: JQC HUAYIN PHARMACEUTICAL
CO., LTD.
Yuqan Road,Huayian City, Shanxi Province.
China
Module III (Drug Substance) Official monograph of Paracetamol and
Caffeine is present in BP and Official monograph
of Aspirin is present in USP. The firm as
submitted detail of nomenclature, structure,
general properties, physical form, manufacturers,
tests for impurity D, G & related substances
(impurity A & unspecified), specifications,
Paracetamol: Real time: 30°C ± 2°C / 65% ±
5%RH for 60 months
months
Batches: (PGP14-37, PGP14-38, PGP14-39)
Caffeine: Real time: 30°C ± 2°C / 65% ± 5%RH
for 60 months
months
Batches: (C-3011 C-3076, C-3115)
Aspirin: Real time: 30°C ± 2°C / 65% ± 5%RH for
12 months
months.
Batches: (A201104081, A201104082,
A201104083
comparative dissolution profile established against the brand leader that is Panadol
Migraine Tablets by M/s GSK (GlaxosmithKline)
Consumer Health, USA performing quality tests
dosage form).
that is Panadol Migraine Tablets by M/s GSK
(GlaxosmithKline) Consumer Health, USA in
Acid media (pH-1.2),Acetate Buffer(pH-4.5) &
Phosphate Buffer (pH 6.8).
Analytical method Method verification studies have submitted
validation/verification of product including linearity, range, accuracy, precision,
specificity.
Manufacturer of API Paracetamol: M/s Citi Pharma Private Limited Lahore.
Aspirin: JQC HUAYIN PHARMACEUTICAL CO., LTD.
API Lot No. Caffeine:
Paracetamol : PGP21-183
Aspirin: A201903162
Description of Pack
(Container closure Alu, PVC foil blister
system)
Batch No. TRA-PM001 TRA-PE002 TRA-PE003
Batch Size 10,000 Tablets 10,000 Tablets 10,000 Tablets
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate Paracetamol: Copy of cGMP certificate on the
of API manufacturer issued by basis of evaluation conducted on 17-12-2020 and
concerned regulatory authority of valid for 2 years
country of origin. Caffeine: Copy of GMP certificate No. NEW-
WHO-GMP/KD/88375/2019/11/30185 issued by
Food and Drug Administration Mahrashtra India-
valid for 19-11-2022
Aspirin:
3. Documents for the procurement of API Paracetamol: Purchase documents Invoice No#
with approval from DRAP (in case of F20-34 Dated: 11-08-2021 of Batch No # PGP21-
import). 513
sheets etc.
testing
accelerated)
Firm submitted NOC as follows:
M/s GlaxoSmithKline Consumer health Pakistan Limited 35-Dockyard Road, West Whraf –Karachi-
Pakistan has provided no objection certificate for utilization of Panadol brand name as under :-
S.No. Brand Name
Further to this, Please note that we have no objection to the use of the brand Name “Panadol” for
the aforementioned products, applied by Citi Pharma for the registration on contract manufacturing
on behalf of GlaxoSmithKline consumer Healthcare Limited Pakistan.
S.No Section Shortcomings Communicated

1. 1.6.5 • Submitted GMP certificate of different site than documents submitted
for drug substance (Caffeine).
• Valid Drug Manufacturing License or Valid Good Manufacturing
Practice (GMP) certificate of the Aspirin manufacturer issued by
relevant regulatory authority of country of origin.
2. 2.3.R.1.1 Provide copy of Batch Manufacturing Record (BMR) for all the batches
section 3.2.P.8.3
3. 3.2.S.4.1 Copies of the Drug substance specifications and analytical procedures
used for routine testing of the Drug substance /Active
(Caffeine)Pharmaceutical Ingredient by Drug Product manufacturer is
required.
4. 3.2.S.4.3 Analytical Method Verification studies including specificity, accuracy
and repeatability (method precision) performed by the Drug Product
manufacturer for drug substance(s) (Paracetamol and Caffeine and
Aspirin)shall be submitted.
5. 3.2.S.4.4 Provide results of analysis of relevant batch(es) of Drug Substance
performed by Drug Product manufacturer used during product
development and stability studies, along with Certificate of Analysis
(CoA) of the same batch from Drug Substance / Active Pharmaceutical
Ingredient (Paracetamol and Caffeine) manufacture.
6. 3.2.S.5 COA of primary / secondary reference standard including source and lot
number for Caffeine and Aspirin shall be provided.
7. 3.2.P.1 • Composition of tablet is different from reference product in terms of
excipients.
• Applied formulation is film coated however it is not evident from
composition in section 3.2.P.1 and 3.2.P.3.2 as there are no
excipients for coating.
8. 3.2.P.2.3 Manufacturing process Coating step is not included however applied
product is film coated.
9. 3.2.P.2.2.1 Submitted CDP data for paracetamol and Caffeine is same as in Panadol
Extra tablet. Clarification s is required.
10. 3.2.P.3.5 Submitted Process validation protocol are general not product related.
11. 3.2.P.5.1 Justify your acceptance criteria for dissolution test as NLT 75% after 60
minutes of the labeled amount of paracetamol ,caffeine and Aspirin while
USP has specified as NLT 75% (Q) of the labelled amounts of
acetaminophen , Aspirin and caffeine is dissolved
12. 3.2.P.5.3 Analytical Method Verification studies performed by the Drug Product
manufacturer for drug product shall be submitted.
13. 3.2.P.6 COA of primary / secondary reference standard including source and lot
number for paracetamol, Aspirin and Caffeine shall be provided
14. 3.2.P.8 • Manufacturing of batches was done in Dec, 2021 than how stability
studies started in September 2021.
• Documents for the procurement of API (Caffeine and Aspirin) with
approval from DRAP
Previous Decision (M-321): Deferred for following:

• Submitted GMP certificate of different site than documents submitted for drug
substance (Caffeine).
• Valid Drug Manufacturing License or Valid Good Manufacturing Practice (GMP)
certificate of the Aspirin manufacturer issued by relevant regulatory authority of
country of origin.
• Provide copy of Batch Manufacturing Record (BMR) for all the batches of drug
product for which stability studies data is provided in Module 3 section 3.2.P.8.3
• Copies of the Drug substance specifications and analytical procedures used for routine
testing of the Drug substance /Active (Caffeine)Pharmaceutical Ingredient by Drug
Product manufacturer is required.
• Analytical Method Verification studies including specificity, accuracy and
repeatability (method precision) performed by the Drug Product manufacturer for
drug substance(s) (Paracetamol and Caffeine and Aspirin)shall be submitted.
• Provide results of analysis of relevant batch(es) of Drug Substance performed by
Drug Product manufacturer used during product development and stability studies,
along with Certificate of Analysis (CoA) of the same batch from Drug Substance /
Active Pharmaceutical Ingredient (Paracetamol and Caffeine) manufacture.
Caffeine and Aspirin shall be provided.
• Composition of tablet is different from reference product in terms of excipients.
• Applied formulation is film coated however it is not evident from composition in
section 3.2.P.1 and 3.2.P.3.2 as there are no excipients for coating.
• Manufacturing process Coating step is not included however applied product is film
coated.
• Submitted CDP data for paracetamol and Caffeine is same as in Panadol Extra tablet.
Clarification s is required.
• Submitted Process validation protocol are general not product related. Clarification is
required.
• Justify your acceptance criteria for dissolution test as NLT 75% after 60 minutes of
the labeled amount of paracetamol ,caffeine and Aspirin while USP has specified as
NLT 75% (Q) of the labelled amounts of acetaminophen , Aspirin and caffeine is
dissolved
paracetamol, Aspirin and Caffeine shall be provided
• Manufacturing of batches was done in Dec, 2021 than how stability studies started in
September 2021.
• Documents for the procurement of API (Caffeine and Aspirin) with approval from
DRAP
Reply
S.No Section Shortcomings Reply
Communicated
1. 1.6.5 • Submitted GMP • Caffeine: Firm submitted now GMP
certificate of different certificate # 6101335 valid upto 12-
site than documents 08-2022 of Aarti Industries Limited
submitted for drug Address: K-17/18/19, M.I.D.C,
substance (Caffeine). tararpur, District, Thane zone 4.(
• Valid Drug mentioned on all documents)
Manufacturing License • In Chinese submitted which can
or Valid Good not be read.
Manufacturing
Practice (GMP)
certificate of the
Aspirin manufacturer
issued by relevant
regulatory authority of
country of origin.
2. 2.3.R.1.1 Provide copy of Batch Submitted.
Manufacturing Record
(BMR) for all the batches
of drug product for which
stability studies data is
provided in Module 3
section 3.2.P.8.3
3. 3.2.S.4.1 Copies of the Drug Copies of the Drug substance specifications
substance specifications (BP) and analytical procedures used for
and analytical procedures routine testing of the Drug substance
used for routine testing of /Active Pharmaceutical Ingredient
the Drug substance /Active (Caffeine) by Drug Product manufacturer is
(Caffeine)Pharmaceutical submitted.
Ingredient by Drug
Product manufacturer is
required.
4. 3.2.S.4.3 Analytical Method Analytical method verification of tablet
Verification studies (Drug Product) submitted instead of
including specificity, drug substance.
(method precision)
drug substance(s)
(Paracetamol and Caffeine
and Aspirine)shall be
submitted.
5. 3.2.S.4.4 Provide results of analysis COA of paracetamol and Aspirin
of relevant batch(es) of submitted while, COA of drug substance
Drug Substance performed for Caffeine of a different Drug
by Drug Product substance supplier (Kores India limited
manufacturer used during submitted.
product development and
stability studies, along
with Certificate of
Analysis (CoA) of the
same batch from Drug
Substance / Active
(Paracetamol and
Caffeine) manufacture.
6. 3.2.S.5 COA of primary / Submitted.
secondary reference
and lot number for
Caffeine and Aspirin shall
be provided.
7. 3.2.P.1 • Composition of tablet • Correct formulation as per
is different from reference product attached.
reference product in • Revised section 3.2.P.1 and 3.2.P.3
terms of excipients. are attached.
• Applied formulation is
film coated however it
is not evident from
composition in section
3.2.P.1 and 3.2.P.3.2
as there are no
excipients for coating.
8. 3.2.P.2.3 Manufacturing process Correct manufacturing method
Coating step is not submitted.
included however applied
product is film coated.
9. 3.2.P.2.2.1 Submitted CDP data for Correct CDP with F2 calculations
paracetamol and Caffeine submitted.
is same as in Panadol
Extra tablet. Clarification s
is required.
10. 3.2.P.3.5 Submitted Process Submitted.
validation protocol are
general not product
related. Clarification is
required.
11. 3.2.P.5.1 • Justify your Correction is done and revised
acceptance criteria for specifications
dissolution test as NLT
75% after 60 minutes
of the labeled amount
of paracetamol
,caffeine and Aspirin
while USP has
specified as NLT 75%
(Q) of the labelled
amounts of
acetaminophen ,
Aspirin and caffeine is
dissolved
12. 3.2.P.5.3 Analytical Method Not submitted.
drug product shall be
submitted.
13. 3.2.P.6 COA of primary / Submitted.
secondary reference
and lot number for
paracetamol, Aspirin and
Caffeine shall be provided
14. 3.2.P.8 • Manufacturing of Not submitted.
batches was done in
Dec, 2021 than how
stability studies started
in September 2021.
• Stability studies of
three (03) months
submitted.
• Documents for the
procurement of API
(Caffeine and Aspirin)
with approval from
DRAP
(Paracetamol and Caffeine and Aspirine) shall be submitted.
• Justification for initiating stability studies in Se [ptember 2021, whereas manufacturing
of batches was done in Dec, 2021.
• Documents for the procurement of API (Caffeine and Aspirin) with approval from
DRAP.
• Documents for the procurement of API (Caffeine and Aspirin) with approval from DRAP
• Clarity regarding drug substance manufacturer since COA of drug substance for
Caffeine of two different Drug substance manufacturers has been submitted.
• Since the submitted dossier does not reflect any details for contract manufacturing while
annexed NOC from M/s GlaxoSmithKline Consumer Health declare it by way of cntract
manufacturing hence firm shall submit clarity regarding the status of registration
application whether it’s for self-manufacturing with registration in name of M/s Citi
Pharma Private Limited or for contract manufacturing with registration in name of M/s
GlaxoSmithKline Consumer health Pakistan Limited. In case of contract manufacturing
for M/s GlaxoSmithKline Consumer health Pakistan Limited, the application shall be re
submitted as per relevant SRO of contract manufacturing policy.
• Clarification for using of Panadol brand name as per Rule 20A of Drugs (L,R &A) Rules,
1976.
Case no. 02 Registration applications for local manufacturing of (Human) drugs on form 5
a. New cases
213.Name and address of manufacturer / M/s Wnsfeild Pharmaceuticals. Plot no. 122,
Applicant Phase V, Block A, Industrial Estate Hattar.
Brand Name +Dosage Form + Strength Betawin 16m Tablet
Composition Each Uncoated Tablet Contains:
Betahistine Dihydrochloride …….16mg
Diary No. Date of R& I & fee Dy.No 39685 dated 03-12-2018 Rs.20,000/-
Dated 03-12-2018
Pharmacological Group Anti-Vertigo
Type of Form Form 5
Finished product Specifications BP
Approval status of product in Reference Betahistine of MHRA Approved
Me-too status Betalin Tablet 16mg by Linear Pharma
(081873)
GMP status Last GMP inspection of Wnsfeild conducted
on 18-01-2018, wherein renewal of DML
was recommended.
Remarks of the Evaluator:
Revise your master formulation Revise master formulation according to applied

according to applied strength. strength is submitted.
Decision: Approved. The firm shall submit full fee for correction/pre-approval change
in master formulation as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-
2021
214.Name and address of manufacturer / M/s Wnsfeild Pharmaceuticals. Plot no. 122,
Applicant Phase V, Block A, Industrial Estate Hattar.
Brand Name +Dosage Form + Strength Nazodin 100mg Tablets
Phenazopyridine Hydrochloride ….…
100mg
Dated 03-12-2018
Pharmacological Group Analgesic,Drugs for urological pain
Type of Form Form 5
Finished product Specifications USP
Approval status of product in Reference PHENAZO of BAUSCH HEALTH,
Regulatory Authorities CANADA INC Health Canada approved.
Me-too status Uropyrine 100mg Tablet by Ontech
Corporation Karachi (Reg no. 041200)
GMP status Last GMP inspection of Wnsfeild conducted
on 18-01-2018, wherein renewal of DML
was recommended.
Decision: Approved.
Case no. 03 Registration applications of newly granted DML or New section (Human)
a. New DML
M/s Fleming Pharmaceutical. (New DML)
CLB in its 282nd meeting held on 31st August 2021 has considered and approved the grant of Drug
Manufacturing License by way of formulation with following five (05) sections to M/s M/s Fleming
Pharmaceutical.
1. 1Oral Dry Powder for suspension(Penicillin)
2. 2Capsule (Penicillin)
3. 3Tablet (Penicillin)
4. Dry Powder Injectable (Penicillin)
5. Dry Powder Injectable (Carbapenem)
Accordingly, firm has applied for following products for consideration by Drug Registration Board
Capsule (Penicillin)
01 Molecules/ 02 Products
215.Name, address of Applicant / Marketing M/s Fleming Pharmaceutical.
Authorization Holder 23- Km Lahore- Sheikhupura Road, Lahore.
Name, address of Manufacturing site. M/s Fleming Pharmaceutical.
23- Km Lahore- Sheikhupura Road, Lahore.
☐ Importer
☐ Export sale
☒Domestic and Export sales
Flemox 250 mg
name
Strength / concentration of drug of Each capsule contains:
Active Pharmaceutical ingredient (API) Amoxicillin ………….…. 250 mg (as Amoxicillin
per unit trihydrate)
Pharmaceutical form of applied drug Maroon cap and yellow body Capsule shell #2 filled
with white to off white powder.
Pharmacotherapeutic Group of (API) Penicillin antibiotic
USP
specifications
The status in reference regulatory Amoxicillin Capsules by M/s US Antibiotics,
For generic drugs (me-too status) Amoxil Capsules by M/s GSK, Reg. No. 000213
GMP status of the Finished product New DML letter issued dated; 14-09-2021
manufacturer
Name and address of API manufacturer. M/s Pharmagen Limited
Kot Nabi Bukshwala 34 Km- Ferozpur Road,
Lahore, Pakistan.
Module III (Drug Substance) Official monograph of Amoxicillin is present in
USP. The firm as submitted detail of nomenclature,
structure, general properties, solubility, physical
Batches: 00013/210/2009, 00013/211/2009,
00013/212/2009)
product.
comparative dissolution profile against the brand leader that is Amoxil 250mg
Capsule by GSK Pakistan Limited (Batch YJ9F) by
Dissolution, Uniformity of dosage form).
CDP has been performed against the same brand by
in Acid media (pH 1.2) & Acetate buffer 4.5 pH and
Phosphate Buffer (pH 6.8) and water . The values for
f1 and f2 are in the acceptable range.
specificity.
Manufacturer of API M/s Pharmagen Limited
Kot Nabi Bukshwala 34 Km- Ferozpur Road, Lahore, Pakistan.
API Lot No. 000130/601/2021
Description of Pack
system)
Batch No. T-001 T-002 T-003
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate Copy of GMP certificate No. 129/2020-DRAP
of API manufacturer issued by concerned (AD/1998630-530) issued by DRAP on the basis of
regulatory authority of country of origin. evaluation conducted on 22-06-2022 and valid for 2
years.
3. Documents for the procurement of API • API had been locally procured from Pharmagen
with approval from DRAP (in case of Ltd.
import).
chromatograms,
sheets etc.
testing
accelerated)
o Communicated
substance specifications and analytical procedures used for routine
and analytical procedures testing of the Drug substance /Active
used for routine testing of Pharmaceutical Ingredient by Drug substance
the Drug substance /Active manufacturer are attached.
by Drug substance
2. 3.2.S.7 Justification is required for Firm submitted the revised stability data in
not performing the which the results of identification test, pH
identification test, pH and and determination of optical rotation test has
determination of optical included.
rotation during the stability
study of drug substance.
3. 3.2.P.3.5 Submitted Process Revised Process validation protocol
validation protocol are submitted.
general not product related.
4. 3.2.P.5.1 • Time for Q not • Revised internal specifications are
mentioned in attached.
specifications. • Firm submitted the revised specification
• USP monograph in which microbial enumeration test and
mentioned Microbial test for specified organism has included.
enumeration test and Further, performance data of microbial
test for specified enumeration test and test for specified
organism. Which is not organism on next time point has also been
performed. Clarification submitted.
is required.
5. 3.2.P.8 • Purchase documents for Purchase documents of different batch no
Amoxicillin. submitted.
• Compliance Record of Later firm submitted the correct purchase
HPLC software 21CFR documents of API.
product testing
and humidity
accelerated)
Decision: Approved.
216.Name, address of Applicant / Marketing M/s Fleming Pharmaceutical. 23- Km Lahore-
Authorization Holder Sheikhupura Road, Lahore.
☐ Importer
☐ Export sale
Flemox 500 mg
name
Strength / concentration of drug of Each capsule contains:
Active Pharmaceutical ingredient (API) Amoxicillin ………….…. 500 mg (as Amoxicillin
Pharmaceutical form of applied drug Maroon cap and yellow body Capsule shell #2 filled
with white to off white powder.
USP
specifications
The status in reference regulatory Amoxicillin Capsules by M/s US Antibiotics,
For generic drugs (me-too status) Amoxil Capsules by M/s GSK, Reg. No. 006669
manufacturer
Lahore, Pakistan.
Module III (Drug Substance) Official monograph of Amoxicillin is present in
Batches: 00013/210/2009, 00013/211/2009,
00013/212/2009)
product.
comparative dissolution profile against the brand leader that is Amoxil 500mg
Capsule by GSK Pakistan Limited (Batch UH2X) by
Phosphate Buffer (pH 6.8) and water . The values for
f1 and f2 are in the acceptable range
specificity.
API Lot No. 000130/601/2021
Description of Pack
system)
Batch No. T-001 T-002 T-003
No. of Batches 03
the firm (if any)
years.
import).
chromatograms,
sheets etc.
testing
accelerated)
o Communicated
substance specifications and analytical procedures used for routine
and analytical procedures testing of the Drug substance /Active
used for routine testing of Pharmaceutical Ingredient by Drug substance
the Drug substance /Active manufacturer are attached.
by Drug substance
2. 3.2.S.7 Justification is required for Firm submitted the revised stability data in
not performing the which the results of identification test, pH
identification test, pH and and determination of optical rotation test has
determination of optical included.
rotation during the
stability study of drug
substance
3. 3.2.P.3.5 Submitted Process Revised Process validation protocol
validation protocol are submitted.
general not product
related. Clarification is
required.
4. 3.2.P.5.1 • Time for Q not • Revised internal specifications are
mentioned in attached.
specifications. • We would like to mention that microbial
• USP monograph enumeration test is not mentioned in
mentioned Microbial specification, as it is not required to be
enumeration test and performed on every batch. Initial testing
test for specified report is attached. Firm submitted the
organism. Which is not revised specification in which microbial
performed. enumeration test and test for specified
Clarification is organism has included. Further,
required. performance data of microbial
enumeration test and test for specified
organism on next time point has also been
submitted.
5. 3.2.P.8 • Purchase documents Purchase documents of different batch no
for Amoxicillin. submitted. Later firm submitted the correct
• Compliance Record of purchase documents of API.
HPLC software 21CFR
product testing
and humidity
chambers (real time
and accelerated)
Decision: Approved.
b. New/Additional section(s)
Deferred case
217. Name, address of Applicant / Marketing M/s Hudson Pharma Private Limited
Authorization Holder D-93, North Western Industrial Zone,
Port Qasim, Karachi, Sindh 75350,
Pakistan.
Name, address of Manufacturing site. M/s Hudson Pharma Private Limited
D-93, North Western Industrial Zone,
Port Qasim, Karachi, Sindh 75350,
Pakistan.
☐ Importer
☐ Export sale
The proposed proprietary name / brand Becloson S Suspension for Nebulisation 0.8mg +
name 1.6mg/2ml
Strength / concentration of drug of Each 2ml of suspension contains:
Active Pharmaceutical ingredient (API) Beclometasone dipropionate…….. 0.8mg
per unit Salbutamol sulphate 1.928mg equivalent to
salbutamol ……….1.6mg
Pharmaceutical form of applied drug Suspension for Nebulisation
Pharmacotherapeutic Group of (API) Corticosteroid and Selective beta-2-
adrenoreceptor agonists
In-house
specifications
Proposed Pack size 2ml × 1’s, 5’s & 10’s
The status in reference regulatory Product is registered in Italian Medicine
authorities Agency (AIFA), with the brand name “Clenil
Compositum” by Chiesi Farmaceutici, Italy.
For generic drugs (me-too status) Manufacturer name: Chiesi Farmaceutici, Italy.
Importer: Chiesi Pharmaceutical (Pvt.) Ltd.
Brand name: Clenil Compositum,
Strength: 0.8mg+1.6mg/2ml,
Registration number: 021199
GMP status of the Finished product New section granted on 24/11/2021
manufacturer Injectable Ampoule BF (steroid) - New
Name and address of API manufacturer. Beclomethasone dipropionate:
FARMABIOS S.p.A.Via Pavia, 1 27027
Gropello Cairoli, (PV) Italy.
Salbutamol sulphate:
LUSOCHIMICA SpA –
Via Giotto 9 – 23871 Lomagna (LC) – ITALY
and its validation, batch analysis and justification
substances.
The firm has summarized information of drug
product including its description, composition,
procedures, validation of analytical procedures,
batch analysis, justification of specifications,
reference standard or materials, container closure
system and stability.
Module III (Drug Substance) Official monograph of Beclomethasone
dipropionate is present in USP and Salbutamol
sulphate is present in BP. The firm has submitted
Stability studies Beclomethasone dipropionate:
months
Batches: (0081300, 0091300, B0111322)
months
Batches: (0031130, 0101515, 0111515,)
months
months
Batches: (SAL 104, SAL 204, SAL 304)
specifications, analytical procedure and its
validation studies, batch analysis and justification
product.
comparative dissolution profile established against the innovator product that is
Clenil Compositum Suspension for Nebulisation
0.8mg+1.6mg/2ml
Batch - 1136521 by Chiesi Farmaceutici, Italy
validation/verification of product including specificity, linearity/range, accuracy,
precision (repeatability and intermediate), Limit of
Quantitation (LOQ), Limit of Detection (LOD)
and robustness.
Manufacturer of API Beclomethasone dipropionate:
M/s FARMABIOS S.p.A.Via Pavia, 1 27027 Gropello Cairoli, (PV) Italy.
M/s LUSOCHIMICA SpA – Via Giotto 9 – 23871 Lomagna (LC) –
ITALY
API Lot No. Beclomethasone dipropionate: 2106DM4
Salbutamol sulphate: SALM119
Description of Pack Two aluminium pouches present in a unit carton with leaflet. Each
(Container closure aluminium pouch contain 2ml x 5s product filled in plastic Ampoule
system) (LDPE) 10 mono dose vials
Batch No. SB-BS-NU-01 SB-BS-NU-02 SB-BS-NU-03
Batch Size 2 Liters 2 Liters 2 Liters
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate Beclomethasone dipropionate:
of API manufacturer issued by concerned Copy of GMP certificate No.IT-API/167/H/2020
regulatory authority of country of origin. issued by Italian Medicine Agency valid till
12/06/2023.
Copy of GMP certificate No.IT-API/69/H/2019
issued by Italian Medicine Agency valid till
03/08/2022.
3. Documents for the procurement of API Beclomethasone dipropionate:
with approval from DRAP (in case of Firm has submitted copy of invoice (invoice#
import). 380) Dated 19-11-2021 cleared by DRAP
Karachi office dated 10-12-2021 specifying
import 0.2g Beclomethasone dipropionate
(Batch# 2106DM4).
Firm has submitted copy of invoice (invoice#
112) Dated 27-03-2020 cleared by DRAP
Karachi office dated 23-04-2022 specifying
import 5kg Salbutamol Sulphate (Batch#
SALM119).
4. Data of stability batches will be Firm has submitted record of testing of all batches
supported by attested respective along with raw data sheets, COA and summary
documents like chromatograms, Raw data sheets.
etc.
5. Compliance Record of HPLC software Firm has submitted audit trail reports on product
21CFR & audit trail reports on product testing.
testing
6. Record of Digital data logger for Firm has submitted record of digital data logger
temperature and humidity monitoring of for temperature and humidity monitoring of real
stability chambers (real time and time and accelerated stability chambers.
accelerated)
S.N Section Shortcomings Communicated Reply
o
1. 1.5.2 Specify the equivalent strength of Each 2ml of suspension contains:
the base for Salbutamol sulfate Beclometasone dipropionate 0.8mg
Salbutamol sulphate 1.928mg equivalent
to salbutamol 1.6mg
2. 1.5.7 Aerosol for Nebulization Our applied formulation is in suspension
mentioned in this section. form which is used as nebulisation for
Clarification is required about aerosol. So, our formulation route of
applied formulation administration is Suspension for
nebulisation for aerosol, and the same has
been mentioned on the innovator (Clenil
Compositum) pack.
3. 2.3.R.1.1 Source of Salbutamol Sulfate in A typographical error in the BMR and we
BMR’s is from Cipla. have used the salbutamol sulfate
Clarification is required. manufactured by Lusochimica and it can
be verified from the CoA of FPP
manufacturer for the same lot number.
4. 3.2.S.4.3 Analytical Method Verification Analytical Method Verification studies

studies including specificity, including specificity, accuracy and
accuracy and repeatability repeatability (method precision)
(method precision) performed by performed by the Drug Product
the Drug Product manufacturer of manufacturer of both drug substances
both drug substances (Beclometasone dipropionate &
(Beclomethasone dipropionate Salbutamol sulphate) shall be submitted.
&Salbutamol sulphate shall be
submitted..
5. 3.2.S.5 COA of primary / secondary With reference to this query we would like
reference standard Testosteron to inform you that at the time of initial
Propionate including source and testing of Beclomethasone Dipropionate,
lot number shall be provided. the internal standard testosterone
propionate was not available to us due to
import constraints of the USP primary
reference standard. Hence, we have used
the same method as per USP without
internal standard and complete validation
has been performed to validate our results
and also compare it with manufacturer
results as well.
Furthermore, we have ordered for

working standard of Testosterone
propionate from Merck, Same will be used
for the release testing in future
consignment. The complete method of
validation is already submitted.
6. 3.2.P.8 • Sterility testing and • We have performed the Sterility
Uniformity of dose units not testing and Uniformity of dose on all
included in initial testing. stability batches and the results are
• Details of Water loss test for 6 within range.
months not submitted.
• Details of Water loss test for 6 months
submitted.
Previous Decision: Registration Board deferred the case for further deliberation regarding
manufacturing requirments of products containing Steriodal and non-steriodal drug substance
in one formulation.
Reply by firm: In this regard, our clear understanding is that introducing a less sensitive active into
the designated steroid manufacturing area is more appropriate/safe than introducing a sensitive active
into general manufacturing area, for all combination products that have both types of ingredients.
Discussion: Registraion Board deliberated the applied formulation and evoked the decision of Board
regarding “Manufcaturing requirements of Dry Powder Inhaler capsules”, wherein it was discussed
that the drug products intended for inhlataional route of administration have local onset of action and
does not go into syetmic circulation hence the same manufacturing facility/section can be used for
such formulations. Moreoever relevant decision of CLB was taken in its 239th meeting and is as under:
1. Steroidal topical preparations like Eye/Ear Drops, Sterile Eye Ointment, External Preparation i.e.
Cream/Ointment/Gel, Lotions, Spray/aerosols, suppositories, vaginal preparation, intra oral
preparations, Nasal drops etc shall be manufactured in General facility/area subject to following
conditions that the:
a. Manufacturers shall have segregated dispensing booths, cleaning validation and controls studies
for processes and adequate system to minimize the potential risk of cross contamination,
b. Commercial marketing of above products shall be allowed by Registration Board after confirmation
and verification of conditions as in (1.a.) above
2. Segregated manufacturing facility shall be required for the manufacturing of Steroidal Injections,
Syrup and Oral Solid dosage forms (Tablet, capsules, granules etc).
In pursuance of the baove cited facts Registration Board decided to allow the manufacturing of
inhalational products of a particular dosage form containing steroidal/general ingredients in the same
manufacturing facility subject to the condition that manufacturers shall have segregated dispensing
booths, cleaning validation and controls studies for processes and adequate system to minimize the
potential risk of cross contamination.
In instant ase M/s Hudson has two approved manufacturing sections titled as “Plastic ampoule (BFS)
section” and “Injectable ampoule BF (Steroid)”, whereas applied formulation is of respule dosage
form. Hence Board decided to ensure the distinction of the available facility of “Injectable ampoule
BF (steroid)” section for the applied dosage form of “Inhalational Respules” the firm shall revise the
title of the said section to avoid cross contamination of steroidal ingredients into the Injectable
preparations. In case the firm intends to apply for the “Steroid injectable dosage forms”, the firm shall
have separatee manufacturing faciluity for it.
Decision: Registration Board approved the applied product of “Becloson S Suspension for
Nebulisation 0.8mg + 1.6mg/2ml” with Innovator’specifications against the available
manufacturing facility of “Injectablel ampoule BF (steroid)” section.
The firm shall submit fee of Rs. 7500/- for correction/pre-approval change in product
Registration Board further directed the firm to revise the title of the section to “Respules (Blow
Fill Seal) section” from Licensing Division before issuance of registration letter.
Case no. 04 Registration applications of drugs for which stability study data is submitted
a. Exemption from onsite verification of stability data
218.Name and address of M/s Sante Pvt Ltd. 245/2-Z, Block 6, PECHS, Karachi
manufacturer / Applicant 75400"
Brand Name +Dosage Form + Brinza Ophthalmic Suspension
Strength "Brinzolamide 1%
Brimonidine Tartrate 0.2%
Brinzolamide…10mg
Brimonidine Tartrate …2mg
Diary No. Date of R& I & fee Dy.No 22189 dated 26-06-2018 Rs.20,000/- 26-06-
2018
Duplicate
Pharmacological Group Anti-glaucoma Preparations and Miotics
Type of Form Form 5
Finished product Specifications Manufacturer Specs
Pack size & Demanded Price As per PRC.
Approval status of product in SIMBRINZA™ (brinzolamide/brimonidine tartrate
Reference Regulator Authorities ophthalmic suspension) 1%/0.2% USFDA Approved.
Me-too status
GMP status 02-07-2019 Conclusion:
Based on the current practices and keeping in view the
attitude of the management towards better compliance
of
GMP their overall compliance level for the said
dosage
form is rated as Good
Remarks of the Evaluator. Firm has ophthalmic section.
• The provided Me too could not be confirmed
Previous Decision Registration Board deliberated that since the referred
me-too product “Simbrinza” was first approved in
268th meeting of Registration Board and Board in
240th meeting has
already decided that stability studies data will be
required for new formulation and its subsequent
generic, hence Board deferred the case for submission
of stability study data as per the guidelines provided in
278th meeting of Registration Board as it’s a
subsequent generic. (M-292)
Drug Brinza Ophthalmic Suspension
"Brinzolamide 1%
Name of M/s Sante Pvt Ltd. 245/2-Z, Block 6, PECHS, Karachi
Manufacturer 75400"
Manufacturer of Brinzolamide: M/s Duke Chem S.A.U. Pol. Industrial Sante Pere Molanta
API Avgda. Mare de Deu de Montserrat 93-99 08799 Olerdola -Barcelona
Brimonidine Tartrate: Farmak, a.s Na vicinci 16/3 Klasterni Hradisko,
77900 Olomouc Czech Republic
API Lot No. Brinzolamide: 332700900
Brimonidine Tartrate: 16021017
Description of Pack
(Container closure 8ml LDPE bottle
system)
Stability Storage Real time : 30°C ± 2° C / 35% ± 5% RH
Condition Accelerated: 40°C ± 2°C / 25% ± 5% RH
Frequency Accelerated:0,3,6 ( month)
Real Time: 0,3,6 (month)
Batch No. 08T 09T 10T
Batch Size 5 Liter 5 Liter 5 Liter
Manufacturing 10-2019 10-2019 10-2019
Date
No. of Batches 03
Sr. Documents To Be Provided Status
No.
applications with stability study data product “Zithrosan 1% eye drops” which was
of the firm presented in 289th meeting of Registration Board
wherein the Board decided to approve registration
of this product
Date of inspection: 14th March, 2019.
According to inspection report, following points
were confirmed.
• The firm has 21CFR compliant HPLC software.

stability chamber
2. Certificate of Analysis of API from Brinzolamide: Copy of COA of Brinzolamide
both API Manufacturer and Finished (Batch# 332700900.) from M/s Duke Chem
Product manufacturer. S.A.U. Pol. Industrial Sante Pere Molanta Avgda.
Mare de Deu de Montserrat 93-99 08799 Olerdola
-Barcelona is submitted.
Copy of COA (Batch# 332700900) from M/S

Sante Pvt Ltd is submitted.
Brimonidine Tartrate: Copy of COA of

Brimonidine Tartrate (Batch# 16021017.) from
M/s Farmak, a.s Na vicinci 16/3 Klasterni
Hradisko, 77900 Olomouc Czech Republic is
submitted.
Copy of COA (Batch# 16021017) from M/S Sante

Pvt Ltd is submitted.
3. Method used for analysis of API
from both API Manufacturer and
Finished Product manufacturer
4. Stability study data of API from API Brinzolamide: The firm has submitted copy of
manufacturer accelerated, 06 Months (40°C ± 2°C &
75±5%RH) & long term, 48 Months (30C ± 2°C
& 75±5%RH) stability study reports of 03 batches
Brimonidine Tartrate: The firm has submitted
copy of accelerated, 06 Months (40°C ± 2°C &
75±5%RH) & long term, 60 Months (30C ± 2°C
& 75±5%RH) stability study reports of 03 batches
and Accelerated and Real time stability study
batches
5. Approval of API/ DML/GMP Brinzolamide: Copy of GMP Certificate No #
certificate of API manufacturer NFC_II/2121/001/CAT M/s Duke Chem S.A.U.
issued by concerned regulatory Pol. Industrial Sante Pere Molanta Avgda. Mare de
authority of country of origin. Deu de Montserrat 93-99 08799 Olerdola -
Barcelona issued by Competent Authority of
Ministry of health of Government of Catalonia-
Spain, is submitted. Based on inspection
conducted on 17, 19, 20 & 21 May 2021 valid for
3 years
Brimonidine Tartrate: Copy of GMP Certificate
No # sukis 1705/2019 for M/s Farmak, a.s Na
vicinci 16/3 Klasterni Hradisko, 77900 Olomouc
Czech Republic issued by Competent Authority of
Czech Republic(SUKL), is submitted. Based on
inspection conducted on 14-02-2019 valid for 3
years
6. Documents for the procurement of Brinzolamide: Copy of form 3, form 7 and
API with approval from DRAP (in Commercial Invoice No: E/109709 Dated: 11-01-
case of import). 2018 from M/s gentec Pharmaceutical group and
manufacturer Not attested by AD DRAP for
Brinzolamide batch No# 332700900
Brimonidine Tartrate: Copy of form 3 and
Commercial Invoice No: P1800168 Dated: 04-05-
2018 from M/s Farmak, a.s Na vicinci 16/3
Klasterni Hradisko, 77900 Olomouc Czech
Republic Not attested by AD DRAP for
Brimonidine Tartrate batch No# 16021017.
Airway bill from Farmark A.S Submitted.
7. Protocols followed for conduction
Yes
of stability study
8. Method used for analysis of FPP Yes
9. Drug-excipients compatibility
Same excipients used as used by innovator.
studies (where applicable)
10. Complete batch manufacturing
record of three stability batches.
Brinza Ophthalmic Suspension
"Brinzolamide 1%
Batch No. Bach size Mfg. Started
08T 5 Liter 01-10-2019
09T 5 Liter 03-10-2019
10T 5 Liter 03-10-2019
11. Record of comparative dissolution

Not applicable
data (where applicable)
12. Data of 03 batches will be supported
by attested respective documents
like chromatograms, Raw data Submitted
sheets, COA, summary data sheets
etc.
13. Compliance Record of HPLC
software 21CFR & audit trail reports Submitted
on product testing.
Submitted
REMARKS OF EVALUATOR
S.No Shortcomings communicated Reply

1. Documents for the procurement of Attested not submitted but Airway bill for
API with approval from DRAP Brimonidine Tartrate.
2. Certificate of Analysis of Invoice Submitted contains 2 other batches of
Brinzolamide by API Manufacturer Brinzolamide also included but not attested
and Finished Product manufacturer of
different batch No than batch No
mentioned on commercial invoice,
form 7. Justify
3. Valid Approval of API/ DML/GMP Brinzolamide Valid GMP certificate not submitted
authority of country of origin for both
API.
4. Stability study data of API from API Brimonidine Tartrate stability studies of 2 batches
manufacturer for both API’s submitted
according to zone IV-A
5. Method used for analysis of both API Submitted
from both API Manufacturer and
Finished Product manufacturer.
6. Complete batch manufacturing Fill volume in BMR is 08ml and in stability 05ml
record of three stability batches. mentioned.
7. Brinzolamide overage without any Due to grinding process and transferring losses of
scientific justification. API for brinzolamide suspension 5% overage was
taken into account to meet the product shelf life. It
would further be considered after real time stability
study data till shelf life
8. Stability initiation date not Initiation date submitted
mentioned.
9. COA’s of all time points for real time Submitted
and accelerated stability studies of 3
batches of finished product.
10. Raw data sheets for Assay Submitted
calculations of all time point of
finished products
Second letter
Dated:12-10-2021
S.N Shortcomings
o
1. Documents for the procurement of Submitted but not attested. For Brimonidine
API with approval from DRAP as Tartrate Airway bill submitted.
submitted documents are not attested.
2. In submitted form 7 and Commercial Stability batches 08T, 09T & 10T were
invoice, 03 batch No of Brinzolamide manufactured using Brinzolamide batch #
mentioned while COA of only 1 batch 332700900 having 18L0043D mentioned in Batch
submitted. Clarify which batch was manufacturing record which is traceable through
used in manufacturing of stability raw material test report. For review other two
batches batches COA’s also attached however these are not
used in manufacturing of batches.
3. Valid Approval of API/ DML/GMP Submitted
certificate of API manufacturer issued
by concerned regulatory authority of
country of origin for both API of
Brinzolamide
4. Submit Stability study data of API 3 batches stability studies submitted according to
from API manufacturer of 1 more Zone IV-B
batch according to zone IV-A for
Brimonidine Tartrate as stability
studies of 2 batches submitted
5. Fill volume in BMR is 08ml and in There was a typographical error in the stability data
stability 05ml mentioned. (i.e 5ml mentioned instead of 8ml) So please
Clarification is required consider correct pack size of Brinza Ophthalmic
Suspension as 8ml. Correct reports along with 24th
month stability interval result are attached.
• The firm shall submit fee of Rs. 7500/- for correction/pre-approval change in product
219.Name, address of Applicant / Marketing M/s Vision Pharmaceuticals (Pvt.) Ltd.

Authorization Holder Plot # 22-23, Industrial triangle, kahuta road,
Islamabad-44000
Name, address of Manufacturing site. M/s Vision Pharmaceuticals (Pvt.) Ltd.
Plot # 22-23, Industrial triangle, kahuta road,
Islamabad-44000
☐ Importer
☐ Export sale
Omarigliptin 12.5mg Tablet
name
Active Pharmaceutical ingredient (API) Omarigliptin…..…12.5mg
per unit
Pharmaceutical form of applied drug Green color, round shaped, film coated tablet
Pharmacotherapeutic Group of (API) Dipeptidyl-Peptidase IV Inhibitors (Antidiabetic)
Innovator Specs
specifications
The status in reference regulatory Marizev 12.5mg Tablet by M/s MSD K.K, PMDA
authorities Approved.
For generic drugs (me-too status) OMARIL 12.5mg Tablet by M/s Genix Pharma Pvt.
Ltd., Registration Letter not issued
GMP status of the Finished product The firm is granted GMP certificate based on
manufacturer inspection conducted on 11-02-2019, was valid till
09-05-2022 after extension for 3 months.
Request for GMP inspection R&1 date: 22-12-2021
is provided.
Name and address of API manufacturer. M/s Chifeng Arker Pharmaceutical Technology
Co., Ltd. No.8 Mysun street, hongshan Economic
development Zone, chifeng, Inner Mongolia, China
structure, general properties, solubility’s, physical
form(Crystalline form I), manufacturers,
tests for impurities & related substances (impurity
A & unspecified), specifications, analytical
drug substance
months
Batches: (D85-160101, D85-160102, D85-160201)
comparative dissolution profile against the brand leader that is Marizev 12.5mg
tablets by MSD company limited Tokyo Japan, by
performing quality tests (Physical Appearance,
identification, Average weight, Disintegration
Time, Assay).
that is Marizev 12.5mg tablets by MSD company
limited Tokyo Japan, in Acid media (pH 1.0-1.2) ,
Acetate Buffer (pH 4.5) & Phosphate Buffer (pH
6.8). The values for f1 and f2 are in the acceptable
range.
specificity.
Manufacturer of API M/s Chifeng Arker Pharmaceutical Technology Co., Ltd.
No.8 Mysun street, hongshan Economic development Zone, chifeng, Inner
Mongolia, China
API Lot No. D85-201101
Description of Pack
(Container closure Alu-PVC blister packed in unit carton (4’s)
system)
Batch No. NPD 229 T-01 NPD 229 T-02 NPD 229 T-03
No. of Batches 03
applications with stability study data of stability data of the same dosage form on the basis
the firm (if any) of which Registration Board in 286th meeting
decided to approve registration of Sofovir-V
400mg/100mg Tablet.
Inspection date: 5 & 15 October, 2018
chambers.
2. Approval of API/ DML/GMP certificate Copy of Drug Manufacturing License no.
of API manufacturer issued by concerned 20160053 issued by Inner Mongolia Drug
with approval from DRAP (in case of PSPW-201105) dated 05-11-2020 cleared by DRAP
import).
Islamabad office dated 01-12-2020 specifying
import of Omarigliptin 1Kg (Batch# D85-201101).
chromatograms,
sheets etc.
testing
accelerated)
S.N Shortcomings Communicated Reply
o
1. Differential fee for New Drug Differential fee of Rs.45,000/- has submitted
Product. vide slip no.980938052 dated 14-10-2022.
2. Justify the finished product Firm submitted the drug product analysis in
specification without the test for which test for content uniformity results are
content uniformity.. included.
3. Scientific justification for dissolution Firm replied that “For dissolution test we
parameters including type of followed the USP general chapter 1092.
apparatus, speed and dissolution In reference to minutes of registration board
medium is required. DRAP 291 meeting (2-4th sept 2019) Since the
pKa value of the drug is 8.1 and as per pH pKa
relationship, the drug is more soluble at high
pH.
So by this we take the idea that phosphate buffer
6.8 should be used.
Secondly the release time of the product was
also checked during comparative dissolution
and more than 90% of drug was released in the
medium.
So we followed the above method”.
4. Dissolution medium in section Firm replied that Dissolution medium used for
3.2.P.5.2 phosphate buffer (pH 6.8) the tablets is 6.8 phosphate buffer.
while stability studies protocol 0.01N While 0.01N HCl is a typo mistake in stability
HCl is used as dissolution medium. study protocol. Our testing method have pH 6.8
Clarify buffer.
th
5. Submit 6 month data for stability Submitted
studies.
Decision: Approved.
220.Name, address of Applicant / Marketing M/s Vision Pharmaceuticals (Pvt.) Ltd.
Islamabad-44000
Islamabad-44000
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. 32070. dated 23-09-2021
Omarigliptin 25mg Tablet
name
Active Pharmaceutical ingredient (API) Omarigliptin…..…25mg
per unit
Pharmaceutical form of applied drug Green color, round shaped, film coated tablet
Pharmacotherapeutic Group of (API) Dipeptidyl-Peptidase IV Inhibitors (Antidiabetic)
Innovator Specs
specifications
The status in reference regulatory Marizev 25mg Tablet by M/s MSD K.K, PMDA
For generic drugs (me-too status) OMARIL 25mg Tablet by M/s Genix Pharma Pvt.
Ltd.,
manufacturer inspection conducted on 11-02-2019, was valid till
09-05-2022 after extension for 3 months.
Request for GMP inspection R&1 date: 22-12-2021
is provided.
Name and address of API manufacturer. M/s Chifeng Arker Pharmaceutical Technology
Co., Ltd. No.8 Mysun street, hongshan Economic
development Zone, chifeng, Inner Mongolia, China
form(Crystalline form I), manufacturers,
tests for impurities & related substances (impurity
A & unspecified), specifications, analytical
drug substance
months
Batches: (D85-160101, D85-160102, D85-160201)
comparative dissolution profile against the brand leader that is Marizev 25mg
tablets by MSD company limited Tokyo Japan, by
performing quality tests (Physical Appearance,
identification, Average weight, Disintegration
Time, Assay).
that is Marizev 25mg tablets by MSD company
limited Tokyo Japan, in Acid media (pH 1.0-1.2) ,
6.8). The values for f1 and f2 are in the acceptable
range.
specificity.
Manufacturer of API M/s Chifeng Arker Pharmaceutical Technology Co., Ltd.
No.8 Mysun street, hongshan Economic development Zone, chifeng, Inner
Mongolia, China
Description of Pack
system)
No. of Batches 03
applications with stability study data of stability data of the same dosage form on the basis
the firm (if any) of which Registration Board in 286th meeting
decided to approve registration of Sofovir-V
400mg/100mg Tablet.
chambers.
2. Approval of API/ DML/GMP certificate Copy of Drug Manufacturing License no.
of API manufacturer issued by concerned 20160053 issued by Inner Mongolia Drug
with approval from DRAP (in case of PSPW-201105) dated 05-11-2020 cleared by DRAP
import). Islamabad office dated 01-12-2020 specifying
import of Omarigliptin 1Kg (Batch# D85-201101).
chromatograms,
sheets etc.
testing
accelerated)
o
1. Differential fee for New Drug Differential fee of Rs.45,000/- has submitted
Product. vide slip no. 5269077782 dated 14-10-2022.
2. Justify the finished product Firm submitted the drug product analysis in
specification without the test for which test for content uniformity results are
content uniformity.. included.
3. Scientific justification for dissolution Firm replied that “For dissolution test we
parameters including type of followed the USP general chapter 1092.
apparatus, speed and dissolution In reference to minutes of registration board
medium is required. DRAP 291 meeting (2-4th sept 2019) Since the
pKa value of the drug is 8.1 and as per pH pKa
relationship, the drug is more soluble at high
pH.
So by this we take the idea that phosphate buffer
6.8 should be used.
Secondly the release time of the product was
also checked during comparative dissolution
and more than 90% of drug was released in the
medium.
So we followed the above method”.
4. Dissolution medium in section Firm replied that Dissolution medium used for
3.2.P.5.2 phosphate buffer (pH 6.8) the tablets is 6.8 phosphate buffer.
while stability studies protocol 0.01N While 0.01N HCl is a typo mistake in stability
HCl is used as dissolution medium. study protocol. Our testing method have pH 6.8
Clarify buffer.
5. Submit 6th month data for stability Submitted
studies.
Decision: Approved.
221.Name, address of Applicant / Marketing M/s Himark Laboratories Private Limited Lahore
Name, address of Manufacturing site. M/s Himark Laboratories Private Limited
Plot 37-A, Sundar Industrial Estate Lahore
☐ Importer
☐ Export sale
Details of fee submitted PKR 30000 /-: Deposit slip # 647957126
The proposed proprietary name / brand Himox 400 mg Tablet
name
Active Pharmaceutical ingredient (API) Moxifloxacin as hydrochloride .... 400 mg
per unit
Pharmaceutical form of applied drug White to off-white color oblong shaped film
coated tablet
BP Specs.
specifications
Proposed Pack size 1 ×5’s
The status in reference regulatory AVELOX 400mg tablet M/S Bayer Health Care
authorities Inc. (USFDA Approved).
For generic drugs (me-too status) Mofest 400 mg tablet by M/s Sami Pharmaceuticals
(Pvt.) Ltd.
Reg. No. 050745
manufacturer Tablet (General & General Antibiotic) section
approved.
Lahore, Pakistan.
Characterization, impurities, specifications,
studies of drug substance. The firm has summarized
information of drug product including its
analytical procedures, batch analysis, justification
of specifications, reference standard or materials,
Module III (Drug Substance) Official monograph of Fexofenadine Hydrochloride
is present in BP. Firm has submitted detailed drug
substance data related to nomenclature, structure,
months.
Batches:(LE000510711/001/2018,
LE000510711/002/2018, LE000510711/003/2018)
Module-III (Drug Product): Firm has submitted data of drug product including
Pharmaceutical equivalence and Firm has submitted pharmaceutical equivalence
comparative dissolution profile study of trial formulation (B # T-70) with
comparator product MOXIGET 400mg Tablet (B #
205F31) of M/s GETZ pharma. The results of the
quality tests of both products fall within the
specifications and are comparable. The firm has
performed comparative dissolution profile in pH
1.2, acetate buffer pH 4.5 and phosphate buffer 6.8.
The results showed that similarity factor f2 was
above 50 in three media.
Analytical method validation/verification Firm has submitted report of verification studies of
of product analytical method for the drug substance. Firm has
submitted report of validation of analytical method
for the drug product.
Manufacturer of API Pharmagen Limited Lahore, Pakistan
API Lot No. 00510711/002/2021
Description of Pack
system)
No. of Batches 03
the firm (if any)
years.
3. Documents for the procurement of API API had been locally procured from Pharmagen
import).

chromatograms,
sheets etc.
testing
accelerated)
o
1. Provide copy of Batch Firm submitted the Batch manufacturing record
Manufacturing Record (BMR) for for all the trial batches of drug product.
all the batches of drug product for
which stability studies data is
provided in Module 3 section
3.2.P.8.3
2. Details of analytical Method Submitted
Verification studies including
specificity, accuracy and
repeatability (method precision)
manufacturer for drug substance(s)
shall be submitted.
3. (CoA) of the same batch for Drug Submitted
Substance / /Active Pharmaceutical
Ingredient by drug product
manufacturer shall be submitted.
4. COA of primary / secondary Submitted
and lot number shall be provided.
5. Pharmaceutical Equivalence and Firm submitted the Pharmaceutical equivalence
CDP not performed with Innovator. report and CDP performed against Avelox tablet
Clarification is required 400mg. However the Manufacturer name of
innovator brand, batch no. and expiry date of
brand was not mentioned on the submitted
reports.
6. A brief description of process Submitted
validation including the proposed
protocol shall be submitted.
7. • Specifications claimed are USP Firm claimed that their drug product complies
while in section 1.5.6 claimed as USP specification. Further, submitted the
BP. revised specification of dissolution in
accordance with USP.
• Justify your acceptance criteria
for dissolution test as NLT 80%
of the labeled amount of
Moxifloxacin is dissolved in 30
min; USP has specified as NLT
80% (Q) of the labeled amount
of Moxifloxacin dissolved in 30
min.
8. Compliance Record of HPLC Firm has stated that Audit trail is maintained
software 21CFR & audit trail reports manually.
on product testing.
222. Name, address of Applicant / M/s Martin Dow Limited, Plot no. 37, Sector 19,
Importer Korangi Industrial Area, Karachi
Details of Drug Sale License of License No: 565
importer Address: Martin Dow Limited, Plot no. 37, Sector
19, Korangi Industrial Area, Karachi.
Address of Godown:
(a) 1st floor, Plot no. 211, Sector 23 Korangi
(b) Plot No 32, Sector 16, Korangi Industrial Area,
Karachi
Status: License to sell Drugs by way of Wholesale
Renewal: Yes
Submitted valid till 16-06-2022
Name and address of marketing ANFARM HELLAS S.A.
authorization holder (abroad) 61st km NAT.RD. ATHENS-LAMIA, Schimatari
Viotias 32009, Greece.
Name, address of manufacturer(s) ANFARM HELLAS S.A.
61st km NAT.RD. ATHENS-LAMIA, Schimatari
Local repacking by:
Global Pharmaceuticals Private Limited.
Plot No. 204 – 205, Industrial Triangle, Kahuta
Road, Islamabad, Pakistan
Name of exporting country Greece
Freesale certificate, GMP certificate) (certificate no. 72204) dated 11-08-2021 issued by
National Organization for Medicines (EOF), 284
Mesogeion Ave. 155 62 Holargos Attica, Greece.
The CoPP confirms status of the product in
exporting country as well as GMP status of the
every 3 years.
mentioned as Pakistan.
Free sale in country of origin: Yes
Details of letter of authorization / sole Firm has submitted original, legalized sole agency
agency agreement agreement (letter of authorization) as product
registration holder. The letter specifies that the
manufacturer ANFARM HELLAS S.A., located at
4 Achaias Str. & Trizinias, 14564, Kifisia Attiki
Greece (administration office as per COPP)
appoints M/s Martin Dow Limited, Plot no. 37,
Sector 19, Korangi Industrial Area, Karachi to
register their products in Pakistan. The authorization
letter is issued on 28-06-2021
☒ Importer
☐ Export sale
For imported products, specify one the ☐ Finished Pharmaceutical product import
these ☒ Buk import and local repackaging
purpose only
Details of fee submitted PKR 100,000/- Deposit slip # 97617572626
The proposed proprietary name / brand DOWPENEM INJECTION 500g IV
name
Strength / concentration of drug of Each vial of Powder contains:
Active Pharmaceutical ingredient (API) Meropenem trihydrate equivalent to
per unit Meropenem……….500mg
(with sodium carbonate)
Diluent:
Each ampoule contains:
Sterilized water for injection………….10ml
Pharmaceutical form of applied drug Powder for Injection/ Infusion
Pharmacotherapeutic Group of (API) Carbapenem Antibiotic
Reference to Finished product In House
specifications
Proposed unit price As per DPC
The status in reference regulatory Merrem (Meropenem) Injection 500mg IV
authorities (USFDA Approved).
For generic drugs (me-too status) Meroget Injection of Getz Pharma Pvt. Ltd. (Reg #
083174)
Name, address of drug substance ACS DOBFAR SpA 2:
manufacturer Addetta Site, Viale Addetta, 2a/12-3/5 20067
Tribiano, Milano - Italy
Module-III Drug Substance: Firm has submitted detailed drug substance data for
both sources related to nomenclature, structure,
(Conditions & duration of Stability of API.
studies) Stability study conditions:
Real time: 25oC ± 2oC and 60% RH for 24 months
months
Accelerated Batches: (330772 023 0, 330772 025
0, 330772 027 0)
Real time Batches: (330772 8001 8, 330772 8001
0, 330772 8038 1)
and process control, process validation report,
Pharmaceutical Equivalence and Firm has submitted Pharmaceutical Equivalence
Comparative Dissolution Profile against the innovator product Meronem 500mg by
AstraZeneca Batch no # 14047 C
Analytical method Firm has submitted analytical method validation
validation/verification of product studies for the applied product.
Container closure system of the drug Colourless glass Vial type III sealed with rubber
product stopper and aluminium cap with Plastic flip-off seal
Stability study data of drug product, Accelerated stability studies have been conducted at
shelf life and storage conditions 40oC ±2oC / 75%±5% RH for 06 months.
Real time stability studies conducted at 30 oC±2oC /
65% ± 5% RH for one batch for 36 months ((24410)
and two batches 24 months (36474, 33994)
Batches of stability studies : (24410, 36474, 33994)
Evaluation by PEC:
Sr.no Obseravtions/Shortcoming Reply of the Firm
.
1. Letter of Authorization by Firm replied that the letter for Authorization
ANFARM HELLAS S.A does provided in the submitted dossier states that
not mentioned that label vials Martin Dow Limited has expreseed its
will be imported. willingness to import the products Dowpenem
Injection 500mg &1g in full compliance with
the relevant local and international guidelines
and cGMP standards which actually
corresponds to the labelled vials.
We, hereby clarify that we are importing the
product in the form of labelled vials and final
packaging along with diluents will be done by
Global Pharmaceuticals.
2. Product is available in USP pharmacopeia while applied formulation is claimed
in house specifications. Clarify.
Firm claimed that in-house specifications are more stringent than USP
specifications.
Controls USP monograph of Anafarm’s Release
Meropenem Injection specification
Assay 90%-120% 95%-105%
Content of 80%-120% …
sodium
Sodium carbonate …. 14.7%-16.1%
content
Bacterial NMT 0.12 EU/mg NMT 0.12 EU/mg
Endotoxin
Loss on Drying 9.0%-12.0% 9.0%-12.0%
pH 7.3-8.3 7.3-8.3
Sterility test Sterile Sterile
Particulate Meets the requirements Meets the requirements for
contaminants for SVP injections SVP injections
Uniformity of Meets the requirement Meets the requirement
dosage unit
Further firm stated that Anafarm do not test sodium content ,however the
percentage of sodium carbonate is calculated to be equal to 15.4% i.e. equal to
6.7% (w/w) sodium, so the limits are between 6.7-7.0%.
3. Certificate of analysis by both Firm submitted a declaration letter from
drug substance manufacturer ANFARM HELLAS S.A in which it is stated
and drug product manufacturer that we,Anafarm S.A. receives Meropenem
not submitted. sterile bulk and not the API Meropenem
trihydrate.Thus no analysis on the API is
performed and thus no method verification is
performed.
4. Manufacturing process does Firm submitted the reply in which it is stated
not show blending of Sodium that the mixing of the excipient Sodium
carbonate with meropenem carbonate lyophilized sterile with the API
trihydrate neither by API meropenem trihydrate sterile is considered as
manufacturer nor by ANFARM the first step of the manufacturing process of
HELLAS S.A the sterile bulk.
5. Data of compatibility studies Firm submit commitment that they perform
has been submitted with compatibility studies of the product with the
ANFARM HELLAS S.A locally purchased diluent before marketing of
diluent while in this case the product.
diluent will be locally
purchased and no compatibility
studies conducted. Justify.
6. Stability studies provided by Firm submit commitment that stability studies
drug product manufacturer for the final product packaged by Global
ANFARM HELLAS S.A while Pharmaceuticals will be performed for the first
product will be imported as three consecutive batches of commercial scale.
labelled vials and final
packaging will be done by
Justify.
7. Please specify final quality Firm claimed that final quality release site will
control release site. be Global Pharmaceuticals and the finished
product specification are according to USP.
8. Steps of packaging not Submitted
mentioned performed in the
global pharmaceuticals.
• Justification of not performing test of Sodium content test by M/s Anfarm as
recommended by USP monograph.
• Analytical method verification studies of drug substance performed by M/s Anfarm.
• Details regarding Packaging, Quality control analysis and batch release activities to be
conducted by M/s Global pharmaceuticals.
223. Name, address of Applicant / M/s Martin Dow Limited, Plot no. 37, Sector 19,
Importer Korangi Industrial Area, Karachi
importer Address: Martin Dow Limited, Plot no. 37, Sector
19, Korangi Industrial Area, Karachi.
Address of Godown:
(a) 1st floor, Plot no. 211, Sector 23 Korangi
(b) Plot No 32, Sector 16, Korangi Industrial Area,
Karachi
Status: License to sell Drugs by way of Wholesale
Renewal: Yes
Submitted valid till 16-06-2022
Name and address of marketing ANFARM HELLAS S.A.
authorization holder (abroad) 61st km NAT.RD. ATHENS-LAMIA, Schimatari
Name, address of manufacturer(s) ANFARM HELLAS S.A.
61st km NAT.RD. ATHENS-LAMIA, Schimatari
Local repacking by:
Global Pharmaceuticals Private Limited.
Plot No. 204 – 205, Industrial Triangle, Kahuta
Road, Islamabad, Pakistan
Name of exporting country Greece
Freesale certificate, GMP certificate) (certificate no. 72204) dated 11-08-2021 issued by
National Organization for Medicines (EOF), 284
Mesogeion Ave. 155 62 Holargos Attica, Greece.
The CoPP confirms status of the product in
exporting country as well as GMP status of the
every 3 years.
The name of importing country on COPP is
Free sale in country of origin: Yes
Details of letter of authorization / sole Firm has submitted original, legalized sole agency
agency agreement agreement (letter of authorization) as product
registration holder. The letter specifies that the
manufacturer ANFARM HELLAS S.A., located at
4 Achaias Str. & Trizinias, 14564, Kifisia Attiki
Greece (administration office as per COPP)
appoints M/s Martin Dow Limited, Plot no. 37,
Sector 19, Korangi Industrial Area, Karachi to
register their products in Pakistan. The authorization
letter is issued on 28-06-2021
☒ Importer
☐ Export sale
For imported products, specify one the ☐ Finished Pharmaceutical product import
these ☒ Buk import and local repackaging
purpose only
Details of fee submitted PKR 150,000/- deposit Slip # 5765002081
The proposed proprietary name / brand DOWPENEM INJECTION 1g IV
name
Strength / concentration of drug of Each vial of Powder contains:
Active Pharmaceutical ingredient (API) Meropenem trihydrate equivalent to
per unit Meropenem……….1000mg
(with sodium carbonate)
Diluent:
Each ampoule contains:
Sterilized water for injection………….20ml
Pharmaceutical form of applied drug Powder for Injection/ Infusion
Pharmacotherapeutic Group of (API) Carbapenem Antibiotic
Reference to Finished product In House
specifications
The status in reference regulatory Merrem (Meropenem) Injection 1000mg IV
authorities (USFDA Approved).
For generic drugs (me-too status) Meroget Injection of Getz Pharma Pvt. Ltd. (Reg #
083175)
Name, address of drug substance ACS DOBFAR SpA 2:
manufacturer Addetta Site, Viale Addetta, 2a/12-3/5 20067
Tribiano, Milano - Italy
(Conditions & duration of Stability of API.
studies) Stability study conditions:
Real time: 25oC ± 2oC and 60% RH for 24 months
months
Accelerated Batches: (330772 023 0, 330772 025
0, 330772 027 0)
Real time Batches: (330772 8001 8, 330772 8001
0, 330772 8038 1)
and process control, process validation report,
Pharmaceutical Equivalence and Firm has submitted Pharmaceutical Equivalence
Comparative Dissolution Profile against the innovator product Meronem 500mg by
AstraZeneca Batch no # 14047 C.
Firm submitted justification “The manufacturer
of Meropenem injection 500mg and 1g ha
performed the pharmaceutical Equivalence on the
same Powder of Merpenem trihydrate that is filled
in the vials of both 500mg and 1g. Hence,
Pharmaceutical equivalence of one strength
(500mg) with the Innovator brand shall be
considered as as pharmaceutical equivalence of the
other strength (1g)
That is why the manufacturer has covered the same
pharmaceutical equivalence under the heading of
both strengths.
Moreover, the parameters covering in
pharmaceutical equivalence of Meropenm injection
500mg are general and can be used for bulk powder
testing. Hence confirming the point of equivalence
for meropenem injection”
Container closure system of the drug Colourless glass Vial type III sealed with rubber
product stopper and aluminium cap with Plastic flip-off seal
Stability study data of drug product, Accelerated stability studies have been conducted at
shelf life and storage conditions 40oC ±2oC / 75%±5% RH for 06 months.
Real time stability studies conducted at 30 oC±2oC /
65% ± 5% RH for one batch for 36 months (317121)
and two batches 24 months (31523, 31813)
Batches of stability studies : (317121, 31523, 31813)
Evaluation by PEC:
Sr.no Obseravtions/Shortcoming Reply of the Firm
.
1. Letter of Authorization by Firm replied that the letter for Authorization
ANFARM HELLAS S.A does provided in the submitted dossier states that
not mentioned that label vials Martin Dow Limited has expreseed its
will be imported. willingness to import the products Dowpenem
Injection 500mg &1g in full compliance with
the relevant local and international guidelines
and cGMP standards which actually
corresponds to the labelled vials.
We, hereby clarify that we are importing the
product in the form of labelled vials and final
packaging along with diluents will be done by
2. Product is available in USP pharmacopeia while applied formulation is claimed
in house specifications. Clarify.
Firm claimed that in-house specifications are more stringent than USP
specifications.
Controls USP monograph of Anafarm’s Release
Meropenem Injection specification
Assay 90%-120% 95%-105%
Content of 80%-120% …
sodium
Sodium carbonate …. 14.7%-16.1%
content
Bacterial NMT 0.12 EU/mg NMT 0.12 EU/mg
Endotoxin
Loss on Drying 9.0%-12.0% 9.0%-12.0%
pH 7.3-8.3 7.3-8.3
Sterility test Sterile Sterile
Particulate Meets the requirements Meets the requirements for
contaminants for SVP injections SVP injections
Uniformity of Meets the requirement Meets the requirement
dosage unit
Further firm stated that Anafarm do not test sodium content ,however the
percentage of sodium carbonate is calculated to be equal to 15.4% i.e. equal to
6.7% (w/w) sodium, so the limits are between 6.7-7.0%.
3. Certificate of analysis by both Firm submitted a declaration letter from
drug substance manufacturer ANFARM HELLAS S.A in which it is stated
and drug product manufacturer that we,Anafarm S.A. receives Meropenem
not submitted. sterile bulk and not the API Meropenem
trihydrate.Thus no analysis on the API is
performed and thus no method verification is
performed.
4. Manufacturing process does Firm submitted the reply in which it is stated
not show blending of Sodium that the mixing of the excipient Sodium
carbonate with meropenem carbonate lyophilized sterile with the API
trihydrate neither by API meropenem trihydrate sterile is considered as
manufacturer nor by ANFARM the first step of the manufacturing process of
HELLAS S.A the sterile bulk.
5. Data of compatibility studies Firm submit commitment that they perform
has been submitted with compatibility studies of the product with the
ANFARM HELLAS S.A locally purchased diluent before marketing of
diluent while in this case the product.
diluent will be locally
purchased and no compatibility
studies conducted. Justify.
6. Stability studies provided by Firm submit commitment that stability studies
drug product manufacturer for the final product packaged by Global
ANFARM HELLAS S.A while Pharmaceuticals will be performed for the first
product will be imported as three consecutive batches of commercial scale.
labelled vials and final
packaging will be done by
Justify.
7. Please specify final quality Firm claimed that final quality release site will
control release site. be Global Pharmaceuticals and the finished
product specification are according to USP.
8. Steps of packaging not Submitted
mentioned performed in the
global pharmaceuticals.
• Justification of not performing test of Sodium content test by M/s Anfarm as
recommended by USP monograph.
• Analytical method verification studies of drug substance performed by M/s Anfarm.
• Details regarding Packaging, Quality control analysis and batch release activities to be
conducted by M/s Global pharmaceuticals.
224.Name, address of Applicant / Marketing M/s Dyson Research Laboratories PVT. LTD.
Authorization Holder 28-km, Ferozepur Road, Lahore.
Name, address of Manufacturing site. M/s Dyson Research Laboratories Private Limited
28-km, Ferozepur Road, Lahore.
☐ Importer
☐ Export sale
Valatine Tablet 25mg
name
Active Pharmaceutical ingredient (API) Agomelatine……………..25mg
per unit
Pharmaceutical form of applied drug Light yellow colored, oblong film coated tablet with
cut line on one side and Dyson engraved on other
side.
Pharmacotherapeutic Group of (API) Psychoanaleptic
Innovator
specifications
Proposed Pack size 5’s, 10’s, 14’s, 20’s, 28’s, 30’s, 50’s & 100’s
The status in reference regulatory Valdoxan 25 mg film-coated tablets by M/s Les
authorities Laboratoires Servier, France.
For generic drugs (me-too status) Valdoxan tablet 25mg of M/s. Servier (Reg. #
078160)
GMP status of the Finished product Last inspection was conducted on 13-07-2020 for
manufacturer renewal of DML.
Tablet (General, Hormonal) Liquid syrup (General),
Oral dry powder suspension (General), and Capsule
(general) section approved.
Name and address of API manufacturer. M/s. Changzhou Pharmaceutical
Factory No.518 Laodong East Road, Changzhou,
Jiangsu Province, China
Module III (Drug Substance) Official monograph of Agomelatine is not available
in any official pharmacopoeia. The firm has
submitted detail of nomenclature, structure, general
drug substance
months
Batches: (120301, 120302, 120401)
drug product.
comparative dissolution profile against the brand leader that is Valdoxan 25mg
tablet by Servier Research and Pharmaceuticals by
is Valdoxan 25mg Tablet by Servier Research and
Pharmaceuticals in Acid media (pH 1.0-1.2) &
Phosphate Buffer (pH 6.8) & acetate buffer (pH 4.5).
The values for f1 and f2 are in the acceptable range.
Manufacturer of API M/s. Changzhou Pharmaceutical Factory No.518 Laodong East Road,
Changzhou, Jiangsu Province, China.
API Lot No. AG190601
Description of Pack
(Container closure PVC-Alu blister packed in unit carton (1×10’s)
system)
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate Copy of DML # Su20160138 certificate issued Food
of API manufacturer issued by and Drug Administration Jiangsu Province valid till
concerned regulatory authority of 24-09-2025.
country of origin.
with approval from DRAP (in case of CYI19233) dated 16-07-2019 cleared by DRAP
import). Lahore office dated 01-08-2019 specifying import of
Agomelatine Citric acid co- crystal 150g (Batch#
AG190601).
sheets etc.
testing
accelerated)
o
1. Analytical Method Verification Submitted
studies including specificity,
accuracy and repeatability (method
precision) performed by the Drug
Product manufacturer for drug
substance(s) shall be submitted
2. As per Commercial Invoice Firm replied that “we have imported only
Agomelatine Citric acid co- crystal agomelatine, while agomelatine citric acid co-
was imported, while submitted crystal mentioned on invoice is merely a human
documents for drug substance and error/typing error.
applied formulation mentions only Valdoxan 25 mg film-coated tablets (innovator
Agomelaine. Clarify. brand approve in MHRA have agomelatine as an
active ingredient.
Decision: Approved.
• Frim shall ensure import of drug substance in form of “Agomelatine” base only as per
innovator product, for commercial manufacturing of applied drug product
☐ Importer
☐ Export sale
Flemicillin 250 mg
name
Strength / concentration of drug of Each hard gelatin capsule contains:
Active Pharmaceutical ingredient (API) Ampicillin ………….…. 250 mg (as Ampicillin
Pharmaceutical form of applied drug Black cap and red body Capsule shell #2
filled with white to off white powder.
BP Specifications
specifications
The status in reference regulatory Ampicillin 250mg Capsules by M/s Cresecent
authorities Pharma Limited, MHRA Approved.
For generic drugs (me-too status) Penbritin Capsules by M/s GSK, Reg. No. 000188
manufacturer
Lahore, Pakistan.
Module III (Drug Substance) Official monograph of Ampicillin is present in BP.
The firm as submitted detail of nomenclature,
months
Ampicillin Batches: 00003/001/2015,
00003/002/2015, 00003/003/2015)
drug product.
comparative dissolution profile against the brand leader that is Penbritin 250mg
Capsule by GSK Pakistan Limited (Batch WV7H)
Phosphate Buffer (pH 6.8) and water . The values
specificty.
API Lot No. 00003/054/2021
Description of Pack
system)
Batch No. T-001 T-001 T-001
Batch Size 2000 Capsules 2000 Capsules 2000 Capsules
No. of Batches 03
the firm (if any)
of API manufacturer issued by (AD/1998630-530) issued by DRAP on the basis of
concerned regulatory authority of evaluation conducted on 22-06-2022 and valid for 2
country of origin. years.
import). • Copy of commercial invoice attached.
sheets etc.
testing
accelerated)
o
1. Copies of the Drug substance Submitted
specifications and analytical
procedures used for routine testing of
the Drug substance /Active
Pharmaceutical Ingredient by Drug
2. Specificity and Submitted
Precision(Repeatability) data of drug
substance not submitted.
3. Justification is required for not Stability studies by the API manufacturer of
performing the identification test, pH recent batches including all these parameters
and determination of optical rotation is submitted.
during the stability study of drug
substance
4. Submitted Process validation protocol Revised process validation protocol is
are general not product related. submitted.
5. Time for Q not mentioned Revised internal specifications are submitted.
6. Q mentioned in Specifications is NLT Firm submitted the revised drug product
80% (Q+ 5%) while in analytical specification data in which the dissolution
testing method is NLT 75% (Q+ 5%). acceptance criteria is NLT 80% (Q), time
Clarification is required. limit has not mentioned in the acceptance
criteria.
7. • Purchase documents for Submitted
Ampicilline.
• Record of Digital data logger for
Decision: Approved.
☐ Importer
☐ Export sale
Flemicillin 500 mg
name
Strength / concentration of drug of Each hard gelatin capsule contains:
Active Pharmaceutical ingredient (API) Ampicillin ………….…. 500 mg (as Ampicillin
Pharmaceutical form of applied drug Black cap and red body Capsule shell #2
filled with white to off white powder.
BP Specifications
specifications
The status in reference regulatory Ampicillin 500mg Capsules by M/s Cresecent
authorities Pharma Limited, MHRA Approved.
For generic drugs (me-too status) Penbritin Capsules by M/s GSK, Reg. No. 000189
manufacturer
Lahore, Pakistan.
Module III (Drug Substance) Official monograph of Ampicillin is present in BP.
months
Ampicillin Batches: 00003/001/2015,
00003/002/2015, 00003/003/2015)
drug product.
comparative dissolution profile against the brand leader that is Penbritin 500mg
Capsule by GSK Pakistan Limited (Batch RY9X) by
Phosphate Buffer (pH 6.8) and water . The values
specificty.
API Lot No. 00003/054/2021
Description of Pack
system)
Batch No. T-001 T-002 T-003
No. of Batches 03
the firm (if any)
of API manufacturer issued by (AD/1998630-530) issued by DRAP on the basis of
concerned regulatory authority of evaluation conducted on 22-06-2022 and valid for 2
country of origin. years.
import). • Copy of commercial invoice attached.
sheets etc.
testing
accelerated)
o
1. Copies of the Drug substance Submitted
specifications and analytical
procedures used for routine testing of
Pharmaceutical Ingredient by Drug
2. Specificity and Submitted
Precision(Repeatability) data of drug
substance not submitted.
3. Justification is required for not Stability studies by the API manufacturer of
performing the identification test, pH recent batches including all these parameters
and determination of optical rotation is submitted.
during the stability study of drug
substance
4. Submitted Process validation protocol Revised process validation protocol is
are general not product related. submitted.
5. Time for Q not mentioned Revised internal specifications are submitted.
6. Q mentioned in Specifications is NLT Firm submitted the revised drug product
80% (Q+ 5%) while in analytical specification data in which the dissolution
testing method is NLT 75% (Q+ 5%). acceptance criteria is NLT 80% (Q), time
Clarification is required. limit has not mentioned in the acceptance
criteria.
7. • Purchase documents for Submitted
Ampicilline.
Decision: Approved.
227.Name and address of manufacturer / M/s Ameer & Adnan Pharmaceutical Pvt Ltd.
Applicant Plot No.47, Sundar Industrial Estate, Lahore
Brand Name +Dosage Form + Strength Zolid 100mg Capsule
Itraconazole…100mg
Diary No. Date of R& I & fee Dy.No 7898 dated 22-02-2019 Rs.20,000/- Dated
22-02-2019
Pharmacological Group Antifungal
Type of Form Form 5
Finished product Specifications Manufacturer’s specifications
Pack size & Demanded Price 4’ s, 10’s ,As per SRO
Approval status of product in Itraconazole 100 mg capsules of( MHRA approved)
Me-too status Itrax Capsule by M/s Ferozsons Labs
GMP status Last GMP inspection conducted on 05-01-2018

and report concludes that firm had maintained
conformance to cGMP.
Remarks of the Evaluator The reference product contains pellets of
itraconazole while applied formulation contains
powder. Justify your formulation in line with the
reference product.
Response of firm Firm submitted the reference of MHRA approved
product, which is also the yellowish beige color
micro granules filled in hard capsule.
specifications of each strength as per notification No.F.7-11/2012-B&A/DRAP dated
07-05-2021.
• Registration letter will be issued upon submission of requisite documents i.e., COA,
GMP, and stability studies for the source of pellets.
228.Name and address of manufacturer / M/s High-Q Pharmaceuticals B-64, KDA, Scheme
Applicant No. 1, Main Karsaz Road, Karachi, Pakistan
Brand Name +Dosage Form + Strength Levixa XR 500mg Tablet
Composition Each extended release tablet contains:
Levetiracetam……500mg
Diary No. Date of R& I & fee Dy.No. 40498 dated 06-12-2018 Rs.20,000/-
Dated 05-12-2018
Pharmacological Group Antiepileptic
Type of Form Form-5
Pack size & Demanded Price 10’s, 30’s: As per SRO
Approval status of product in Levetiracetam of (MHRA Approved)
Letrawin Tablets 500mg of M/s Opal
Me-too status
Laboratory
GMP status Last GMP inspection conducted on 10-04-18, and
the
report concludes that the firm was considered to
be operating at an acceptable level of compliance
with good manufacturing practices
Remarks of the Evaluator Applied formulation is extended release so which
polymer is used to make extended release tablet
Response of the Firm Firm submitted the revised formulation without
any polymer used for extended release profile.
Decision: Approved. Registration letter will be issued upon submission of master
formulation declaring the excipients for extended release profile along with fee of Rs.
7500/- for correction/pre-approval change in master formulation as per notification
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
229.Name and address of manufacturer / M/s High-Q Pharmaceuticals
Applicant B-64, KDA, Scheme No. 1, Main Karsaz Road,
Karachi, Pakistan
Brand Name +Dosage Form + Strength Pequit XR 150mg Tablet
Quetiapine as fumarate eq to Questiapine…150mg
Dated 05-12-2018
Pharmacological Group Antipsychotic Drugs
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s ; As per SRO
Approval status of product in Seroquel XR of USFDA approved.
Me-too status Qusel XR 150mg Tablet of M/s Hilton Pharma
the
Remarks of the Evaluator Master formulation do not contain any polymer for
extended release tablet. Submit master formulation
and manufacturing method in line with reference
product.
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Karachi, Pakistan
Dated 05-12-2018
Type of Form Form 5
the
product.
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Karachi, Pakistan
Dated 05-12-2018
Type of Form Form 5
the
product.
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Karachi, Pakistan
Dated 05-12-2018
Type of Form Form 5
the
product.
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Karachi, Pakistan
Brand Name +Dosage Form + Strength Tramax 100mg SR Capsule
Composition Each Sustained Release Capsule Contains:
Tramadol Hcl…100mg
Dated 07-12-2018
Pharmacological Group Narcotic analgesic
Type of Form Form 5
Finished product Specification BP
Pack size & Demanded Price 10’s, 20’s, 30’s: As per SRO
Approval status of product in CONZIP 100mg Capsules of ( USFDA
Reference Regulatory Authorities approved)
Zultra SR 100mg of M/s. Wilshire
Me-too status
Laboratories
the
Remarks of the Evaluator Submit Master formula, manufacturing method,
analytical method
CIP-TRAMADOL ER (tramadol hydrochloride)
extended-release) capsules are a new formulation
of tramadol HCl for analgesia. The drug product
consists of extended release film coated white
beads and an immediate release tablet
encapsulated in white opaque, size 1, 0 and 00,
hard gelatin capsules
Dosage Immediat Extended
e release release
100 mg 25 mg 75 mg
Decision: Deferred for review of formulation against the innovator product.
Karachi, Pakistan
Brand Name +Dosage Form + Strength Flunar 5mg Capsule
Flunarizine Hcl Eq. to Flunarizine Base…5mg
Dated 07-12-2018
Pharmacological Group Narcotic analgesic
Type of Form Form 5
Finished product Specification Manufacturer specification
Pack size & Demanded Price 3’s, 6’s, 10’s, 12: As per SRO
Approval status of product in Approved by Health Canada
Migram 5mg Capsule of M/S Wilshire
Me-too status
Laboratories
the report concludes that the firm was considered
to be operating at an acceptable level of
compliance with good manufacturing practices
Remarks of the Evaluator Firm submitted the evidence of approval of applied
formulation in Health Canada along with revised
manufacturing method, formulation.
specifications and correction of pharmacological group as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021.
235.Name and address of manufacturer / M/s Sante Pvt Ltd. 245/2-Z, Block 6, PECHS,
Applicant Karachi 75400"
Brand Name +Dosage Form + Strength Xenase 2.5mg Tablet
Olopatadine as Hydrochloride eq to
Olopatadine……..2.5mg
Diary No. Date of R& I & fee Dy.No (Duplicate Dossier) dated 27-02-2014
Rs.15,000/- (Copy)
Pharmacological Group Decongestants And Antiallergics
Type of Form Form 5
Pack size & Demanded Price 3 x 10’s
Approval status of product in PMDA japan approved
Reference Regulator Authorities
Me-too status
Based on the current practices and keeping in view
the
attitude of the management towards better
compliance of
dosage
Drug Xenase 2.5mg Tablet
Name of M/s Sante Pvt Ltd. 245/2-Z, Block 6, PECHS, Karachi 75400"
Manufacturer
Manufacturer of M/S Crystal Pharma, S.A.U., a subsidiary of AMRI Parque technologico de
API Boecillo, Parcela 105. 47151 Boecillo, Valladolid spain
API Lot No. V0673/0 16010
V0673/0 19040
Description of Pack
(Container closure PVDC Alu blister
system)
Stability Storage Real time : 30°C ± 2° C / 65% ± 5% RH
Batch # 01T: 24 months
Batch # 02T and 03T :09 months
Frequency Accelerated:0,3,6 ( month)
Real Time:
Batch # 01T: 0,3,6,9,12,18,24 (month)
Batch # 02T and 03T : 0,3,6,9 (month)
No. of Batches 03
Date of Submission 11-02-20221(4705)
Sr. No. Documents To Be Provided Status
1. Reference of previous approval of Firm has referred to onsite inspection report of
applications with stability study data of the their product “Zithrosan 1% eye drops” which
firm (if available) was presented in 289th meeting of Registration
Board wherein the Board decided to approve
registration of this product
were confirmed.
• The firm has 21CFR compliant HPLC

software.
Adequate monitoring and control are available
for stability chamber
2. Certificate of Analysis of API from both Copy of COA of Olopatadine HCl (Batch#
API Manufacturer and Finished Product V0673/0 16010 and V0673/0 19040) from M/S
manufacturer. Crystal Pharma, S.A.U., a subsidiary of AMRI
Parque technologico de Boecillo, Parcela 105.
47151 Boecillo, Valladolid spain is submitted.
Copy of COA (Batch# V0673/0 16010 and

V0673/0 19040) from M/S Sante (Pvt) Ltd is
submitted
3. Method used for analysis of API from both
API Manufacturer and Finished Product
manufacturer
4. Stability study data of API from API The firm has submitted copy of accelerated, 06
manufacturer Months (40°C ± 2°C & 75±5%RH) & long
term, 60 Months (25°C ± 2°C & 60±5%RH)
stability study reports of 03 batches
5. Approval of API/ DML/GMP certificate Copy of GMP Certificate No # ES/057/20 for
of API manufacturer issued by concerned M/s Crystal Pharma, S.A.U., Planta API no
regulatory authority of country of origin. esteroides site address Parque technologico de
Boecillo, Parcela 105. 47151 Boecillo,
Valladolid Spain issued by Agencia Espanola
de Medicamentos y productos Sanitarious, is
submitted. Based on inspection conducted on
13-03-2020 valid for 3 years
6. Documents for the procurement of API Copy of form3, form 7 and Commercial
with approval from DRAP (in case of Invoice No: 20190001 Dated: 10-01-2019
import). from M/S Crystal Pharma, S.A.U., is submitted
attested by AD(Karachi) dated ; 15-01-2019 for
Oloptadine HCl quantity 2KG Batch #
V0673/0 16010
Copy of Commercial Invoice No: 20190001
Dated: 10-01-2019 from M/S Crystal Pharma,
S.A.U., a subsidiary of AMRI is submitted
Oloptadine HCl quantity 2KG Batch #
V0673/0 19040
7. Protocols followed for conduction of
Yes
stability study
8. Method used for analysis of FPP In house specifications but available in
japnease pharmacopiea
9. Drug-excipients compatibility studies Same excipients used as used by innovator.
(where applicable) Excipients are different
10. Complete batch manufacturing record of The firm has submitted copy of Trial batch
three stability batches. manufacturing record.
Details are as under:
Xenase 2.5mg Tablet
Batch No. Bach size Mfg.
Started
01T 8000 14-11-2017
Tablets
02T 8000 16-12-2019
Tablets
03T 8000 16-12-2019
Tablets
11. Record of comparative dissolution data
(where applicable)
12. Data of 03 batches will be supported by
testing.
accelerated)
• Differential fee of RS: 35000/- for new molecule.

• Reference of previous approval of applications with stability study data of the firm (if
available)
• Method used for analysis of API from both API Manufacturer and Finished Product
manufacturer.
• Stability study data of API from API manufacturer.
• Documents for the procurement of Olopatadine HCl batch no # V0673/0 16010 with
approval from DRAP
• Method used for analysis of FPP inhouse while product is available in Japanese
pharmacopeia. Clarification is required for inhouse specifications.
• Drug-excipients compatibility studies
• Record of comparative dissolution data.
• Content uniformity is not included in initial certificate of analysis. Clarification is required.
• Raw data sheets for calculations of assay, dissolution and content uniformity for all time
point of finished products.
• Compliance Record of HPLC software 21CFR & audit trail reports on product testing.
• Record of Digital data logger for temperature and humidity monitoring of stability chambers
(real time and accelerated).
236.Name and address of manufacturer / M/s Sante Pvt Ltd. 245/2-Z, Block 6, PECHS,
Applicant Karachi 75400"
Brand Name +Dosage Form + Strength Xenase 5mg Tablet
Olopatadine Hydrochloride ……..5mg
2011
Pharmacological Group Decongestants And Antiallergics
Type of Form Form 5
Finished product Specifications Manufacturer’s specification
Pack size & Demanded Price 3 x 10’s
Approval status of product in PMDA japan approved
Reference Regulator Authorities
Me-too status
Based on the current practices and keeping in view
the
attitude of the management towards better
compliance of
dosage
Drug Xenase 5mg Tablet
Name of M/s Sante Pvt Ltd. 245/2-Z, Block 6, PECHS, Karachi 75400"
Manufacturer
Manufacturer of M/S Crystal Pharma, S.A.U., a subsidiary of AMRI Parque technologico de
API Boecillo, Parcela 105. 47151 Boecillo, Valladolid spain
API Lot No. V0673/0 16010
V0673/0 19040
Description of Pack
(Container closure PVDC Alu blister
system)
Stability Storage Real time: 30°C ± 2° C / 65% ± 5% RH
Batch # 01T: 24 months
Batch # 02T and 03T :09 months
Frequency Accelerated:0,3,6 (month)
Real Time:
Batch # 01T: 0,3,6,9,12,18,24 (month)
Batch # 02T and 03T : 0,3,6,9 (month)
No. of Batches 03
Date of Submission 11-02-20221(4706)
applications with stability study data of the their product “Zithrosan 1% eye drops” which
firm (if available) was presented in 289th meeting of Registration
Board wherein the Board decided to approve
registration of this product
were confirmed.
• The firm has 21CFR compliant HPLC

software.
for stability chamber
2. Certificate of Analysis of API from both Copy of COA of Olopatadine HCl (Batch#
API Manufacturer and Finished Product V0673/0 16010 and V0673/0 19040) from M/S
manufacturer. Crystal Pharma, S.A.U., a subsidiary of AMRI
Parque technologico de Boecillo, Parcela 105.
47151 Boecillo, Valladolid spain is submitted.
Copy of COA (Batch# V0673/0 16010 and

V0673/0 19040) from M/S Sante (Pvt) Ltd is
submitted
manufacturer
manufacturer Months (40°C ± 2°C & 75±5%RH) & long
term, 60 Months (25°C ± 2°C & 60±5%RH)
5. Approval of API/ DML/GMP certificate Copy of GMP Certificate No # ES/057/20 for
of API manufacturer issued by concerned M/s Crystal Pharma, S.A.U., Planta API no
regulatory authority of country of origin. esteroides site address Parque technologico de
Boecillo, Parcela 105. 47151 Boecillo,
Valladolid Spain issued by Agencia Espanola
de Medicamentos y productos Sanitarious, is
submitted. Based on inspection conducted on
13-03-2020 valid for 3 years
6. Documents for the procurement of API Copy of form3, form 7 and Commercial Invoice
with approval from DRAP (in case of No: 20190001 Dated: 10-01-2019 from M/S
import). Crystal Pharma, S.A.U., is submitted attested
by AD(Karachi) dated ; 15-01-2019 for
Oloptadine HCl quantity 2KG Batch # V0673/0
16010
Copy of Commercial Invoice No: 20190001
Dated: 10-01-2019 from M/S Crystal Pharma,
S.A.U., a subsidiary of AMRI is submitted
Oloptadine HCl quantity 2KG Batch # V0673/0
19040
Yes
stability study
8. Method used for analysis of FPP In house specifications but available in japnease
pharmacopiea
9. Drug-excipients compatibility studies Same excipients used as used by innovator.
(where applicable) Excipients are different
10. Complete batch manufacturing record of The firm has submitted copy of Trial batch
three stability batches. manufacturing record.
Xenase 5mg Tablet
Started
01T 6667 Tablets 14-11-2017
02T 6667 Tablets 16-12-2019
03T 6667 Tablets 16-12-2019
(where applicable)
testing.
accelerated)
• Differential fee of RS: 35000/- for new molecule.

• Reference of previous approval of applications with stability study data of the firm (if
available)
• Method used for analysis of API from both API Manufacturer and Finished Product
manufacturer.
• Stability study data of API from API manufacturer.
• Documents for the procurement of Olopatadine HCl batch no # V0673/0 16010 with approval
from DRAP
• Method used for analysis of FPP inhouse while product is available in Japanese pharmacopeia.
Clarification is required for inhouse specifications.
• Drug-excipients compatibility studies
• Record of comparative dissolution data.
• Content uniformity is not included in initial certificate of analysis. Clarification is required.
• Raw data sheets for calculations of assay, dissolution and content uniformity for all time point
of finished products.
• Record of Digital data logger for temperature and humidity monitoring of stability chambers
237. Name and address of manufacturer / M/s Rotex Pharma Pvt Ltd.
Applicant Plot No. 206 & 207. Industrial Triangle,
Kahuta
Road, Islamabad
Brand Name +Dosage Form + Strength Zovir 250mg/10ml Injection
Composition Each 10ml Vial Contains:
Acyclovir…250mg
Dated 06-03-2019
Pharmacological Group Antiviral
Type of Form Form 5
Pack size & Demanded Price 1’s (10ml); As per SRO
Approval status of product in Zovirax I.V. 250 mg of MHRA approved
Me-too status (with strength and Aclovir 250mg Powder for infusion of Genix
dosage form) pharma Reg# 073690
GMP status cGMP certificate on the basis of Evaluation
conducted on 11-08-2022
Previous remarks of the Evaluator.
Previous decision(s) Deferred for following reasons:
Deferred for consideration on its turn. (M-296)
Decision of 320th meeting of Reg. Board Deferred for confirmation of required
manufacturing facility / section (lyophilized
vial General )
Response of the Firm Firm replied that they had applied for liquid
injection and in RRA both liquid and powder
injection are available.
Decision: Deferred for submission of detail of applied formulation in line with product
available in approved reference regulatory agencies and confirmation of generic status
of liquid injection along with registration number, brand name and name of firm.
Kahuta
Road, Islamabad
Brand Name +Dosage Form + Strength Zovir 500mg/20ml Injection
Composition Each 20ml vial Contains:
Acyclovir…500mg
Dated 06-03-2019
Pharmacological Group Antiviral
Type of Form Form 5
Pack size & Demanded Price 1’s (20ml) ; As per SRO
Approval status of product in Zovirax I.V. 500 mg of MHRA approved
Me-too status (with strength and Aclovir 500mg Powder for infusion of Genix
dosage form) pharma Reg# 073691
GMP status CGMP certificate on the basis of Evaluation
Previous remarks of the Evaluator. • Evidence of applied formulation/drug
already approved by DRAP (generic / me-
too status) alongwith registration number,
Decision of 320th meeting of Reg. Board Deferred for confirmation of required
manufacturing facility / section (lyophilized
vial General )
Response of the Firm Firm replied that they had applied for liquid
injection and in RRA both liquid and powder
injection are available.
Decision: Deferred for submission of detail of applied formulation in line with product
available in approved reference regulatory agencies and confirmation of generic
status of liquid injection along with registration number, brand name and name of
firm.
Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Irofit Tablet 20mg/2.5mg
Iron protein succinylate 400mg eq to elemental
iron …20mg
Folic Acid……..2.5mg
Dated 06-03-2019
Pharmacological Group Antianemic preparations
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s, 20’s , :As per SRO
Approval status of product in Not found
Me-too status (with strength and Eisen Tablets of Genome Pharmaceuticals
dosage form)
Previous remarks of the Evaluator. Evidence of approval of applied
formulation in reference regulatory
authorities/agencies which were
declared/approved by the Registration
Board in its 275th meeting
Decision of 320th meeting The Board deferred the case for submission of
detail of specifications and complete analytical
method for the applied product.
Response of the Firm Firm submitted the detailed specification and
complete analytical procedure of applied
formulation.
Decision: Approved.
Kahuta
Road, Islamabad
Brand Name +Dosage Form + Strength Methane 1% w/v Lotion
Permethrin…10mg
Dated 06-03-2019
Pharmacological Group Pyrethroid insecticide
Type of Form Form 5
Pack size & Demanded Price 30ml: As per SRO
Approval status of product in Nix lotion of USFDA approved
Me-too status (with strength and Not found
dosage form)
Previous remarks of the Evaluator. • Evidence of applied formulation/drug
already approved by DRAP (generic /
me-too status) along with registration
number, brand name and name of firm.
Decision of 320th meeting Deferred for evidence of applied
formulation/drug already approved by DRAP
(generic / me-too status) along with registration
Remarks of the Firm Firm submitted the evidence of Me-too product
Z-X Lotion of M/s. Martin Dow Limited Reg.
no. 067937
Decision: Approved.
241. Name and address of manufacturer / M/S Fredmann Pharmaceuticals Plot # 82-83 B,
Applicant Old Industrial Area Mirpur, Azad Kashmir
Brand Name +Dosage Form + Strength Bresco 5mg Chewable Tablet
Composition Each chewable tablet contains:
Montelukast as (sodium)……5mg
Diary No. Date of R& I & fee Dy.No.2471; 23-02-2017; Rs.20,000/- (23-02-
2017)
Pharmacological Group Leukotriene receptor antagonist
Type of Form Form 5
Pack size & Demanded Price 2 x 7’s ; As per SRO
Approval status of product in Reference Singulair 5mg chewable of (USFDA approved)
Me-too status (with strength and dosage Lontuka 5mg Chewable Tablet M/s Linz
form) Pharmaceuticals.
GMP status Last GMP inspection conducted on 24-11-2017
,and the report concludes that firm was at fair
level of GMP
Remarks of the Evaluator Firm changed the formulation from film coated to
chewable tablet.
Decision of 281st meeting of Registration Deferred for submission of fee for revision of
Board formulation
Response of the Firm Firm submitted the fee of Rs.30,000/- vide slip
no. 05725608 dated 24-10-2022
Decision: Approved
Deferred Cases of Previous Meetings:
242. Name, address of Applicant / Marketing M/s News Pharma Lahore

Authorization Holder Plot 42, Sundar Industrial Estate Lahore
Name, address of Manufacturing site. M/s News Pharma
Plot 42, Sundar Industrial Estate Lahore
☐ Importer
giver)
☐ Export sale
Dy. No. and date of submission Dy. No.10562 dated: 27-04-2022
Newfate 1 g / 10 mL Suspension
name
Strength / concentration of drug of Each 10 mL contains:
Active Pharmaceutical ingredient (API) Sucralfate ….....1 g
per unit
Pharmaceutical form of applied drug Liquid suspension filled in amber glass bottle
sealed
with pilfer proof aluminium caps.
Pharmacotherapeutic Group of (API) Cytoprotective agent (Drugs for Peptic Ulcer
and Gastro-Oesophageal Reflux Disease -
GORD)
ATC Code: A02BX02
Innovator’s Specs.
specifications
Proposed Pack size 60 mL , 120 mL, 400 mL
The status in reference regulatory Carafate 1 g / 10 mL Suspension by M/s
authorities Allergan Pharmaceuticals Approved by
USFDA
For generic drugs (me-too status) Ulsanic 500 mg/5 ml Suspension M/s
Highnoon Laboratories, Reg. No. 032072
GMP status of the Finished product New additional section of Oral Liquid general
manufacturer section approved on : 28-10-2021 letter issued
on: 12-11-2021 and inspection conducted on:
28-07-2021
Name and address of API manufacturer. M/S Northeast Pharmaceutical group Co. Ltd.
No. 29 Shenxiliu dong road, Economic
Technological Development District
SHENGYANG. P.R. CHINA
PD template. Summarized information related
months
months
Batches: (DY0011500185, DY0011500186 &
DY0011500187)
Pharmaceutical equivalence and The Firm has performed pharmaceutical
comparative dissolution profile equivalence of their developed formulation
New-fate Suspension with comparator product
Ulsanic Suspension of Highnoon
Laboratories.
specificity.
Manufacturer of API M/S Northeast Pharmaceutical group Co. Ltd. No. 29 Shenxiliu dong
road, Economic Technological Development District SHENGYANG.
P.R. CHINA.
API Lot No. DY0011900195
Description of Pack Oral Suspension filled in amber glass bottle sealed with pilfer proof
(Container closure aluminium
system) caps.
Batch Size 45 Bottles 45 Bottles 45 Bottles
No. of Batches 03
1. Reference of previous approval of New section
the firm (if any)
2. Approval of API/ DML/GMP certificate The firm has submitted copy of GMP
of API manufacturer issued by concerned Certificate No # LN20190041 for M/S
regulatory authority of country of origin. Northeast Pharmaceutical group Co. Ltd. No.
29 Shenxiliu dong road, Economic
Technological Development District
SHENGYANG. P.R. CHINA issued by China
Food and Drug administration. It is valid till
15-07-2024.
3. Documents for the procurement of API Copy of letter No.14901/2021/DRAP-AD-
with approval from DRAP (in case of CD(I&E) dated 04/10/2021 is submitted
import). wherein the permission to import different
APIs including Sucralfate USP for the
purpose of test/analysis and stability studies is
granted.
Firm has submitted copy of Form 3,form 7 &
invoice (invoice# EXP/71221(20-21) dated:
06-09-2021 specifying import 400g Sucralfate
USP (Batch# DY0011900195) however not
attested by DRAP. Copy of DHL provided.
etc.
5. Compliance Record of HPLC software UV method was used.
testing
temperature and humidity monitoring of Submitted
accelerated)
o
1. 3.2.S.4.2 • Analytical procedures used for • Analytical procedures used for
routine testing of the Drug routine testing of the Drug substance
substance /Active /Active Pharmaceutical Ingredient by
Pharmaceutical Ingredient by Drug substance are attached.
Drug substance is required. • It is clarified that USP monograph
• Specification claimed USP has been used for routine testing of
while Submitted analytical
drug substance.
procedures used for routine
testing of the Drug substance
/Active Pharmaceutical
Ingredient by Drug product
manufacturer are according to
B.P. Clarify which monograph
have been used among USP
or B.P Pharmacopeia
monograph for drug
substance.
2. 3.2.S.4.3 If USP Pharmacopeia followed Analytical verification of Sucrose
than Analytical verification of Octasulfate by drug product manufacturer
sucrose octasulfate by drug is attached.
product manufacturer should be
submitted.
If B.P pharmacopeia followed
than Analytical verification of
sucrose octasulfate and aluminium
by drug product manufacturer
should be submitted
3. 3.2.S.5 Reference standard according to COA of Potassium Sucrose Octasulfate is
USP and B.P is Potassium attached.
sucrose octasulfate while
submitted COA of working
standard of Sucralfate USP.
4. 3.2.P.2.2. • Pharmaceutical equivalence of • Pharmaceutical Equivalence had been
1 the applied drug shall be performed with market brand leader
established with the innovator as Innovator product is not available
product and results of all the in the country. I had be done
quality tests of the developed according to
formulation and the innovator WHO_TRS_902_ANNEX11 report
product shall be submitted and which is attached
discussed.
• Actual Specification is Innovator, BP
• B.P specification mentioned in
mentioned mistakenly.
Pharmaceutical equivalence.
5. 3.2.P.2.5 Preservative effectiveness studies Preservative effectiveness studies
to be performed as per performed as per recommendations of
recommendations of pharmacopoeia) is provided.
pharmacopoeia) shall be provided
6. 3.2.P.5.2 • In assay Content of • Revised method is attached
Aluminium and sucrose • Due to non-Pharmacopeial product,
octasulfate separate are not in-house method had been developed
detected. Clarification should on UV. Method validation is
be submitted in this regard. provided in 3.2. P.5.3.
• In Monograph of Drug
substance assay is conducted
by HPLC while drug product
assay was conducted by U.V.
Clarification is required from
where you have adopted U.V
method for assay.
7. 3.2.P.5.3 Analytical method validation of Analytical method validation of sucrose

sucrose octasulfate not conducted. octasulfate is attached.
Clarification is required
8. 3.2.P.8 Commercial invoice with Copy of DHL provided.
approval from DRAP.
th
Decision of 320 meeting of Registration Board:
Registration Board deferred the case for following:
• Justification of assay of drug product conducted by UV method while drug substance assay
is conducted by HPLC as per USP monograph.
• Performance of assay of drug product as per Revised method.
Reply of the Firm:
Firm submitted the revised analytical procedure of drug product along with verification report in
which assay has been performed on HPLC.
Batch analysis reports of drug product in accordance with revised analytical procedure has also
been submitted by the firm.
Decision: Approved. Firm shall submit analytical performance of long term stability studies
of next time point based upon the revised HPLC method, before issuance of registration
letter.
☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand Newfer Syrup 50 mg/5mL
name
Strength / concentration of drug of Each 5ml contains:
Active Pharmaceutical ingredient (API) Iron (III) Hydroxide Polymaltose Complex
per unit Eq. to Elemental Iron -----50 mg
Folic Acid ……….. 0.35mg
Pharmaceutical form of applied drug Liquid Syrup filled in amber glass bottle sealed
Pharmacotherapeutic Group of (API) Iron Supplement
specifications
Proposed Pack size 60 mL , 120 mL, 400 mL
………
authorities
For generic drugs (me-too status) Ferosoft-FA Syrup by M/S Hilton Pharma ,
Reg. No. 045110
GMP status of the Finished product New additional section of Oral Liquid general
manufacturer section approved on : 28-10-2021 letter issued
on: 12-11-2021 and inspection conducted on:
28-07-2021
Name and address of API manufacturer. Iron Polymaltose Complex: Chemiworld
Pvt. Ltd. Plot No. 97, J- Industrial Estate
Jamrud Peshawar Pakistan.
Folic Acid: Hebei Jiheng Pharmaceutical
Co., Ltd, 1 Weiwu Street, Hengshui City,
Hebei Province, P.R. China 053000
general properties, solubilities, physical
stability studies of both drug substances (i.e.
Iron Polymaltose Complex and Folic acid).
months
Accelerated: 40°C ± 2°C / 75% ± 5%RH for
6 months
Batches of Iron Polymaltose Complex :
(BPS-0405118, BPS-0405119, BPS-0405120)
Folic acid : (021702001, 021702002,
021702003)
including its
development,
manufacture, manufacturing process and
process control, process validation protocols,
comparative dissolution profile equivalence of the developed formulation
Newfer Syrup 50 mg/5mL with comparator
product Ferosoft-FA Syrup by Hilton
Pharma.
specificity.
Manufacturer of API Iron Polymaltose Complex: Chemiworld Pvt. Ltd. Plot No. 97, J-
Industrial Estate Jamrud Peshawar Pakistan.
Folic Acid: Hebei Jiheng Pharmaceutical Co., Ltd, 1 Weiwu Street,
Hengshui City, Hebei Province, P.R. China 053000
API Lot No. Iron Polymaltose Complex: K20-IPC-420
Folic Acid: 022004010
Description of Pack
Oral Suspension filled in Amber glass bottle sealed with pilfer proof
(Container closure
aluminium caps.
system)
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate IPC: The firm has submitted copy of GMP
of API manufacturer issued by concerned Certificate # F.3-20/2017-DRAP-90 on the
regulatory authority of country of origin. basis of inspection conducted on 29-11-2016
for M/S Chemiworld Pvt. Ltd. issued by
DRAP. The firm has submitted application for
issuance of new GMP certificate.
Folic Acid : Copy of GMP certificate No.
HE20170030 issued by China Food and Drug
Administration valid till 26/05/2022.
APIs Folic acid for the purpose of
test/analysis and stability studies is granted.
Firm has submitted copy of Form 3, form 7 &
invoice (invoice# HJG/EXP/0124) dated: 07-
09-2021 specifying import 100g Folic acid
(Batch# 022004010) however not attested by
DRAP. Copy of DHL provided.
etc.
5. Compliance Record of HPLC software UV method used
testing
accelerated)
o
1. 1.6.5 Valid Good Manufacturing Firm submitted copy of request to
Practice (GMP) certificate of the federal inspector of Drugs, Peshawar for
Drug Substance manufacturer issuance of GMP certificate.
issued by relevant regulatory
authority of country of origin for
Iron Polymaltose Complex.
2. 3.2.S.4.1 Drug substance manufacturer and It is clarified that Iron Polymaltose
Drug product manufacturer did Complex is not present in any
not mentioned Which Pharmacopeia and manufacturer has
specifications followed for Iron developed an in-house method. Drug
Polymaltose Complex. Please Product manufacturer also followed the
clarify. Drug Substance manufacturer’s method
for testing
3. 3.2.S.4.2 Analytical procedures used for Analytical Procedures used for routine
routine testing of the both Drug testing of the drug substance / Active
substance /Active Pharmaceutical Pharmaceutical Ingredient by Drug
Ingredient (Iron Polymaltose Substance is attached.
Complex &Folic Acid) by Drug
substance is required
4. 3.2.S.4.3 • In analytical method • It is clarified that sodium nitrile is a
verification of Iron clerical mistake.
polymaltose complex Sodium • Analytical verification according to
nitrile mentioned . clarification analytical testing method of Iron
is required. Polymaltose Complex. Is attached.
• Submit analytical method
• Revised Verification by HPLC is
verification according to
attached.
analytical testing method of
Iron polymaltose complex
• Analytical verification is done
by titration while analytical
testing method of folic acid is
by HPLC. Clarification is
required.
recommendations of pharmacopoeia) is provided.
pharmacopoeia shall be provided
6. 3.2.P.5.1 Specifications claimed are B.P. Revised specification with in-house
provide evidence. specs is attached.
7. 3.2.P.5.2 • Clarification is required that • The Product is not available in any
how drug product analytical Pharmacopeia we have test the
testing method developed. product with in-house testing
• In Drug substance Iron method. The standard & sample
polymaltose complex assay of solutions scan on UV
iron contents and polymaltose Spectrophotometer pick
contents are separately absorbance on maximum nm. After
conducted. While in your
scanning this solution we have
analytical testing method assay
of Iron polymaltose is scan sample solution placebo for
conducted. Justify how the conformation of method
quantity of elemental Iron is absorbance and wavelength.
equivalent to 50mg deducted. • In Drug substance iron
Polymaltose complex assay of iron
contents and Polymaltose contents
are separately conducted but in
syrup have many other excipients
which disturbed in testing so that
we use factor calculation for the
equivalence of Iron Polymaltose
complex to iron. 1mg of Iron is
equivalent to 1.1243mg of Iron
Polymaltose complex
8. 3.2.P.8 • Purchase documents for iron • Iron Polymaltose Complex was
hydroxide polymaltose purchased locally.
• Commercial invoice with • Copy of DHL is provided.
approval from DRAP.
Decision of M-320:
The Board deferred the case for scientific justification of performance of assay testing by using
UV-spectrophotometer instead of using potentiometric titration or atomic absorption
spectrophotometer.
Firm submitted the revised assay procedure in which atomic absorption spectrophotometer has
been used for quantification of iron content.
Decision: Approved. Firm shall submit analytical performance of long term stability studies
of next time point based upon the revised Atomic absorption spectrophotometric method
before issuance of registration letter.
☐ Importer
giver)
☐ Export sale
New-Deslor Syrup 2.5 mg / 5 mL
name
Active Pharmaceutical ingredient (API) Desloratadine .... 0.5 mg
per unit
Pharmaceutical form of applied drug Oral solution filled in amber glass bottle sealed
Pharmacotherapeutic Group of (API) Anti-histamine
Inhouse
specifications
Proposed Pack size 60 mL / 120 mL
The status in reference regulatory New-Clarityn by Merck Sharp and Dhome
authorities Ltd.
Approved by AEPMS (Spanish Agency for
Medicine and Health Products.)
For generic drugs (me-too status) Desora 0.5 mg/mL M/s Continental Pharma,
Reg. No. 055192
GMP status of the Finished product New Section granted on 12/11/2021
manufacturer Oral Liquid General Section approved.
Name and address of API manufacturer. M/s Morepen Laboratories Ltd.
Address: Village-Masulkhana, Parwanoo,
District, Solan, India
procedures
product is submitted
manufacturing
substance.
months
months
Batches: (DH-1501, DH-1502, DH-1503)
including its
development,
process control, process validation protocols,
New-Deslor Syrup with comparator product
Clarinex Syrup of M/s Merck & Co.
specificity.
Manufacturer of API M/s M/s Morepen Laboratories Ltd. Village-Masulkhana, Parwanoo,
Distt.
Solan India.
API Lot No. DH-0106
Description of Pack
Oral solution filled in amber glass bottle sealed with pilfer proof aluminium
(Container closure
caps.
system)
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate The firm has submitted copy of GMP
of API manufacturer issued by concerned Certificate for M/s
regulatory authority of country of origin. Morepen Laboratories Ltd, India issued by
State Drugs
Controller, Controlling cum Licensing
Authority, Baddi,
District Solan. It is valid till 30-04-2022.
APIs Folic acid for the purpose of
Firm has submitted copy of Form 3, form 7 &
invoice (invoice# MME202100508) dated:
14-09-2021 specifying import 0.5Kg
Desloratadine (Batch# DH-0106).
4. Data of stability batches will be
supported by attested respective Submitted
etc.
21CFR & audit trail reports on product Manual audit trail report submitted
testing
accelerated)
o
1. 2.3.R.1.1 Manufacturing method mentioned Short method was mentioned in BMR.
in BMR’s is not same as Now Revise BMR (s) are submitted as
mentioned in section 3.2.P.2.3 and with detailed method as mentioned in
3.2. P.3.5. Clarification is 3.2.P.2.3 and 3.2.P.3.5.
required.
2. 2.3.R.1.2 Manufacturing method mentioned Short method was mentioned in BMR.
in BMR’s is not same as Now Revise BMR (s) are submitted as
mentioned in section 3.2.P.2.3 and with detailed method as mentioned in
3.2. P.3.5. Clarification is 3.2.P.2.3 and 3.2.P.3.5
required
3. 3.2.S.4.3 Testing method of desloratadine is Revised verification by HPLC method is
by HPLC while verification is submitted
done by U.V method.
4. 3.2.S.7 Accelerated stability studies of Accelerated stability studies of drug
drug substance not submitted. substance submitted.
recommendations of pharmacopoeia are provided
pharmacopoeia shall be provided
6. 3.2.P.5.1 Specifications claimed for drug Revised Specification are attached
product are B.P. provide (Inhouse)
evidence.
7. 3.2.P.5.2 Justification is required for The Product is not available in any
performing assay testing by UV pharmacopeia so we have test from
method inhouse testing method. The validation of
testing method is attached in dossier
8. 3.2.P.8 Commercial invoice with Copy of DHL provided.
approval from DRAP.
Decision of M-320:
Registration Board deferred the case for Justification of assay of drug product conducted by UV
method while drug substance assay is conducted by HPLC as per BP monograph.
Reply: Firm submitted the revised assay procedure in which HPLC method has adopted for
quantification of active along with performance report of drug product an revised verification
report.
Decision: Approved with innovator’s specifications. Firm shall submit analytical
performance of long term stability studies of next time point based upon the revised HPLC
method along with submit fee of Rs. 7500/- for correction/pre-approval change in product
specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021 , before
issuance of registration letter
245. Name, address of Applicant / Importer M/s INAYA TRADERS
Flat no. 1, 1st floor, Plot no. A-152 Block-8,
KAECHS, Karachi.
importer Address: Flat no. 1, 1st floor, Plot no. A-152
Block-8, KAECHS, Karachi.
Validity: 21-June-2024
Name and address of marketing Shouguang Fukang Pharmaceuticals Co., Ltd
authorization holder (abroad) Address: No.666 Donghuan Road,
Shounguang City Shandong Province, P.R.
China.
Name, address of manufacturer(s) Shouguang Fukang Pharmaceuticals Co., Ltd
Address: No.999 Wensheng East road,
Shouguang City Country: P.R. China.
Detail of certificates attached (CoPP, Detail of certificates attached (CoPP, Free
Freesale certificate, GMP certificate) sale certificate, GMP certificate)
• Original legalized COPP (Certificate#
ShanDong20222004 ) issued by Shandong
Provincial Drug Adminstration issued on
May,16th , 2022
• Free Sale status: The COPP endorses the
free sale status of the applied product in
China
GMP status: COPP Specified that certifying
authority arrange Periodic inspection of
manufacturing plant and facility and
operations confirms to GMP requirements.
Drug manufacturing License: legalized copy
of DML No# Lu 20160126 submitted and
valid till October ,26,2025
Details of letter of authorization / sole Sole agency agreement has been submitted
agency agreement with M/s Shouguang Fukang Pharmaceuticals
Co., Ltd Dated:30-05-2022 (Copy)
☒ Importer
giver)
Status of application ☐New Drug Product (NDP)
Intended use of pharmaceutical product ☒Domestic sale
☐ Export sale
purpose only
Details of fee submitted PKR 150,000/- Deposit slip # 2179283144
The proposed proprietary name / brand PARACETAMOL 500MG Tablet B.P
name
Strength / concentration of drug of Each tablet Contains:
Active Pharmaceutical ingredient (API) Paracetamol…….500mg
per unit
Pharmaceutical form of applied drug Uncoated Tablet
Pharmacotherapeutic Group of (API) Non-steroidal anti-inflammatory drug
(NSAID)
Reference to Finished product B.P
specifications
Proposed Pack size 20 x 10’s & 1000’s
The status in reference regulatory Paracetamol 500mg Tablets of Fourrts (UK)
authorities Pharmacare Ltd MHRA Approved
Actavis Paracetamol 500mg Tablets of Fourrts
(UK) Pharmacare Ltd MHRA Approved
For generic drugs (me-too status) Panadol 500mg of M/ GSK
general properties, physical form,
Name, address of drug substance Hebei Jiheng Pharmaceuticals Co., LTD
manufacturer Address: No. 1Weiwu Street, Hengshui
Industrial Park, Hebei Province, China.
Module-III Drug Substance: Firm has submitted detailed data for drug
structure, general properties, physical form,
substance.
Stability Studies of Drug Substance Firm has submitted long term stability study
(Conditions & duration of Stability data of 3 batches of drug substance at 25°C ±
studies) 2°C / 60 ± 5% RH for 48 months. The
accelerated stability data is conducted at 40°C
± 2°C / 75 ± 5% RH for 6 months.
Batches: (011608001, 011608002,
011608003)
process validation report, control of
Pharmaceutical Equivalence and Pharmaceutical Equivalence have been
Comparative Dissolution Profile established against Paracetamol 500mg Tablet
by GSK (190312) by performing quality tests
(Identification, Average weight, related
substances, microbial limit, Assay,
Dissolution, Uniformity of weight).
CDP has been performed against the same
brand by in Acid media (pH 1.2) & Acetate
buffer 4.5 pH and Phosphate Buffer (pH 6.8) .
The values for f2 are in the acceptable range.
Analytical method Firm has submitted analytical method
validation/verification of product verification studies of the drug product.
Container closure system of the drug PVC and Aluminium foil
product
Stability study data of drug product, shelf Accelerated stability studies have been
life and storage conditions conducted at 40 oC ±2 oC and 75%±5% RH for
06 months.
Real time stability studies conducted at 30
o
C±2 oC and 65% ± 5% RH for 36months.
Batches: (180611, 180612, 180613)
Evaluation by PEC:
S.No Section Shortcoming
communicated
1. 1.3.1 Name and address of Submitted
marketing authorization
holder (abroad)
2. 3.2.S.4.3 Analytical Method Firm submitted analytical verification studies
Verification studies of drug substance.
accuracy and
repeatability (method
precision) performed by
the Drug Product
manufacturer for drug
substance(s) shall be
submitted.
3. 3.2.S.4.4 Provide results of Firm submitted Certificate of analysis by both
analysis of relevant drug substance manufacturer and drug
batch(es) of Drug product manufacturer.
Substance performed by
Drug Product
manufacturer used
during product
development and
with Certificate of
Analysis (CoA) of the
Substance / /Active
Pharmaceutical
4. 3.2.P.2.2.1 • Submit details of Paracetamol 500mg tablet manufactured
manufacturer, by Accord Healthcare Ireland Ltd
marketing Batch No# 190312
authorization Mfg date: 2019/04
including country of Exp date: 2022/04
origin of product
against which (In initial dossier firm submitted that
pharmaceutical pharmaceutical equivalence and CDP was
equivalence and conducted against Product of GSK in
Comparative reply they submitted that pharmaceutical
dissolution profile equivalence and CDP was conducted
conducted. against Paracetamol 500mg tablet
• F1 or F2 calculation manufactured by Accord Healthcare
for comparative Ireland Ltd )
dissolution not
submitted. • F2 calculations submitted.
Decision of M-321:
The Board deferred the case for clarification since in initial dossier firm submitted that
pharmaceutical equivalence and CDP was conducted against Product of GSK in reply they
submitted that pharmaceutical equivalence and CDP was conducted against Paracetamol 500mg
tablet manufactured by Accord Healthcare Ireland Ltd.
Firm submitted a clarification letter from the QC manager (name of manager was not written) of
M/s. Shouguang Fukang Pharmaceuticals in which it was stated that “ I, on behalf of Shouguang
Fukang Pharmaceuticals would like to inform you here that the pharmaceutical equivalence and
comparative dissolution profile which we have submitted has initially mentioned sample of GSK
Ireland as the product against which our product paracetamol 500mg tablet has been tested, but it
was subsequently corrected as paracetamol 500mg tablet manufactured by Accord Healthcare
Ireland ,Batch no. 190312 we would like to confirm here that GSK Ireland was a typographical
error which was subsequently corrected.
Decision: Deferred for submission of evidence of procurement of innovator drug product
alongwith complete details regarding manufacturer and batch no of the innovator product
for performance of Pharmaceutical equivalence studies.
Item No. V: Agenda of Evaluator-XV (Mst.Saima Hussain)
Cases of Finished Import received on Form 5-F

246.Name, address of Applicant / Importer M/s Himmel Pharmaceuticals (Pvt.) Ltd.
793-D, Block ‘’C’’, Faisal Town Lahore.
Details of Drug Sale License of importer License No: 05-352-0065-016174-D
Address:793-D, Block-C, Faisal Town Lahore
Validity: 06. Feb.2022
Name and address of marketing authorization M/s Beacon Pharmaceuticals Limited
holder (abroad) Plant address: Kathali, Bhaluka, Mymensingh
Bangladesh
Office address: 9/B/2, Toyenbee Circular Road,
Motijheel Dhaka, Bangladesh
Name, address of manufacturer(s) M/s Beacon Pharmaceuticals Limited
Plant address: Kathali, Bhaluka, Mymensingh
Bangladesh
Office address: 9/B/2, Toyenbee Circular Road,
Name of exporting country Bangladesh
Detail of certificates attached (CoPP, Free CoPP: Original legalized COPP (Certificate#
sale certificate, GMP certificate) DA/6-110/2016/3303 issued on 01-06-2020 by
Government of the people’s republic of
Bangladesh, Ministry of Health & Family welfare,
Directorate General of Drug Administration,
Oushad Bhaban, Mohkhali Dhaka-1212,
Bangladesh.
GMP: Firm has submitted Legalized GMP
certificate (Certificate No. DA/6-110/06/10002)
issued by M/s Beacon Pharmaceuticals limited.
Also Renewal certificate is submitted (Certificate
No. DA/6-110/06/4950).
Details of letter of authorization / sole agency Firm has submitted copy of letter of distribution
agreement certificate from Beacon Pharmaceuticals limited.
The letter specifies that the manufacturer appoints
M/s Himmel Pharmaceuticals Pvt. Ltd. to register
their products in Pakistan. The authorization letter
is valid till June, 2025.
☒ Importer
☐ Export sale
purpose only
Dy. No. and date of submission Dy.No. 16109 :Date10.06.2021
Details of fee submitted PKR.100,030/- Date: 29-01-2021
The proposed proprietary name / brand name Sunitix 12.5mg Capsule
Strength / concentration of drug of Active Each capsule contains
Pharmaceutical ingredient (API) per unit Sunitinib Malate INN…….12.5mg
Pharmaceutical form of applied drug Capsule
Reference to Finished product specifications In house
Proposed unit price As per current pricing policy of DRAP
The status in reference regulatory authorities Sutent 12.5mg capsule USFDA approved
For generic drugs (me-too status) Sutent capsule 12.5mg (Pfizer Laboratories)
Reg.no.052225
Name, address of drug substance Nanjing First Pharmaceuticals Co. Ltd. China
manufacturer Room No.2303,Technical Garden B Place
Industrial University No.5 Xinmofang Road,
Nanjing, China
for both sources related to nomenclature,
substance.
Stability Studies of Drug Substance Firm has submitted long term stability study data
(Conditions & duration of Stability studies) of 3 batches of drug substance at 25°C ± 2°C / 60
± 5% RH for 36 months. The accelerated stability
data is conducted at 40°C ± 2°C / 75 ± 5% RH for
6 months
development, manufacture, manufacturing
and stability.
Pharmaceutical Equivalence and Comparative Comparative analysis Studies against the
Dissolution Profile reference product Sutent 12.5mg capsule (Pfizer
Laboratories) has been submitted
Container closure system of the drug product HDPE bottle (each contains 28 capsules)
Stability study data of drug product, shelf life Firm has submitted stability study data of 3
and storage conditions batches.
Accelerated stability studies have been conducted
at 40oC±2oC and 75%±5% RH for 6 months.
Real time stability studies conducted at 30oC±2oC
and 65% ± 5% for 24 months
Evaluation by PEC:
Sr. Observations/Deficiencies/ Short-comings Response of the Firm
no.
1. Submit data of analytical Method Firm has submitted the reply of this query.
verification studies under section 3.2.S.4
repeatability (method precision) since you
have submitted validation studies GC
method for determination of residual
solvent of Sunitinib Malate.
2. Scientific justification is required that how Firm has not submitted the reply of this query.
the applied product will be
pharmaceutically equivalent to the
innovator product i.e. sutent in which the
granules are filled in capsules, while in the
applied product dry powder mixture of
active material and excipient are filled in
capsules.
3. All quality test which have been included Firm has not submitted the reply of this query.
in the finished product specification was
not performed during pharmaceutical
equivalence studies, clarification is
required in this regard.
4. Assay limits mentioned in the Firm has not submitted the reply of this query.
pharmaceutical equivalence data is in
percentage without the clarification that
either it is the quantification of salt or its
base form. While the acceptance criteria
specified in the finished product
specification was content of sunitinib per
capsule :22.50mg to 27. 50mg.Justification
is required regarding the disparity in
acceptance criteria of assay of drug
product.
5. As per the chromatographic condition Firm has not submitted the reply of this query.
specified in the procedure of dissolution
testing under section 3.2.P.2: wavelength
of UV detector was 230nm, column
temperature 25°C and retention time is 2
min (as per chromatograms) while the
chromatographic condition specified under
section 3.2.P.5.2: wavelength of UV
detector is 430nm, column temperature
30°C and retention time is approx.6.0
minutes. Justification is required regarding
the variation in chromatographic condition
despite using the same dissolution medium
i.e.0.1M HCl +0.5% sodium lauryl
sulphate.
6. According to the FDA’s Dissolution Firm has not submitted the reply of this query.
guidance document 2018 (same document
has been referred for innovator product)
the standard dissolution testing condition
for sunitinib malate capsule should be
“Paddle Method (USP apparatus 2) •
Stirring rate = 50 RPM • 500 mL of 0.1N
HCl in aqueous medium • No surfactant in
medium • 37±0.5°C”. While the
dissolution condition specified by the drug
product manufacturer under section 3.2.P.2
and 3.2.P.5.2 was different from the said
FDA’s guidance document. Scientific
justification is required in this regard.
7. Justify the dissolution specification NLT Firm has not submitted the reply of this query.
70% of the labelled amount of sunitinib is
dissolved in 60 minutes since the
acceptance criteria as per the FDA
dissolution database for the innovator
product is “for immediate release solid
oral drug products containing a high
solubility drug substance the dissolution
criterion is Q=80% in 30 minutes”.
8. Same comparative dissolution profile data Firm has not submitted the reply of this query.
has been submitted for sunitix 25 capsule
and sunitix 12.5 capsule, clarification is
9. • Detailed analytical method validation Firm has submitted the revised analytical
report is required mentioning the method validation for drug product.
concentration of test solutions and their
individual results along with the results
of mean value.
• Analytical method validation protocol
specified assay method for capsule
containing granules while the
manufacturing process of drug product
evident that capsule containing dry
powder mixture of active material and
excipient has been prepared.
Justification is required that how the
validation studies performed on assay
method of capsule containing granules
be applied on capsule containing dry
powder mixture of active and excipients.
10. Provide copy of Batch Manufacturing Firm submitted BMR, according to which
Record (BMR) for all the batches of drug 269.19 gm of sunitinib Malate having potency
product under section 2.3.R.1.1, for which of 99.3% has been for manufacturing of 8,000
stability studies data is provided in Module capsule.
3 section 3.2. P.8.
11. Firm has already had registration of sunitinib Malate Capsule imported from Germany and
details are as follows:
Product License Holder:
Aqvida GmbH Kaiser-Wilhelm-Strabe 89 20355 Hamburg Germany.
Manufacturer:
M/s Combino Pharm (Malta) Ltd. HF 60, Hal Far Industrial Estate, Hal Far, Birzebbugia,
BBG3000, Malta.
Sunitinib Aqvida 12.5mg hard capsule (Reg.no.103778)
Sunitinib Aqvida 25mg hard capsule (Reg.no.103779)
Decision: Deferred for submission of following:
• Scientific justification is required that how the applied product will be pharmaceutically
equivalent to the innovator product i.e. sutent in which the granules are filled in capsules,
while in the applied product dry powder mixture of active material and excipient were filled
in capsules.
• Submission of pharmaceutical equivalence report in which all the quality parameters of
drug product specification should be included.
• Justification is required regarding the disparity in acceptance criteria of assay of drug
product, assay limits mentioned in the pharmaceutical equivalence data is in percentage
without the clarification that either it is the quantification of salt or its base form. While the
acceptance criteria specified in the finished product specification was content of sunitinib
per capsule :22.50mg to 27. 50mg.
• Scientific justification is required for using dissolution condition different from the
dissolution parameters recommended in USFDA’s innovator brand review report.
• Justify the dissolution specification NLT 70% of the labelled amount of sunitinib is dissolved
in 60 minutes since the acceptance criteria as per the FDA dissolution database for the
innovator product is “for immediate release solid oral drug products containing a high
solubility drug substance the dissolution criterion is Q=80% in 30 minutes”.
• Same comparative dissolution profile data has been submitted for sunitix 25 capsule and
sunitix 12.5 capsule, clarification is required in this regard.
247. Name, address of Applicant / Importer M/s Himmel Pharmaceuticals (Pvt.) Ltd.
793-D, Block ‘’C’’, Faisal Town Lahore.
Details of Drug Sale License of importer License No: 05-352-0065-016174-D
Address:793-D, Block-C,Faisal Town Lahore
Validity: 06. Feb.2022
Name and address of marketing M/s BEACON Pharmaceuticals Limited
authorization holder (abroad) Plant address: Kathali, Bhaluka, Mymensingh
Bangladesh
Office address: 9/B/2, Toynbee Circular Road,
Name, address of manufacturer(s) M/s BEACON Pharmaceuticals Limited
Bangladesh
Detail of certificates attached (CoPP, Free CoPP: Original legalized COPP (Certificate#
sale certificate, GMP certificate) DA/6-110/2016/3304 issued on 01-06-2020 by
Government of the people’s republic of
Bangladesh, Ministry of Health & Family welfare,
Directorate General of Drug Administration,
Oushad Bhaban, Mohkhali Dhaka-1212,
Bangladesh.
Also Renewal certificate is submitted (Certificate
No. DA/6-110/06/4950).
Details of letter of authorization / sole Firm has submitted copy of letter of distribution
agency agreement certificate from Beacon Pharmaceuticals limited.
their products in Pakistan. The authorization letter
is valid till June, 2025.
☒ Importer
☐ Export sale
purpose only
Dy. No. and date of submission Dy. No.16108 , Date: 10.06.2021
Details of fee submitted PKR.100,030/- Date: 29-01-2021
The proposed proprietary name / brand name Sunitix 25mg Capsule
Strength / concentration of drug of Active Each capsule contains
Pharmaceutical ingredient (API) per unit Sunitinib Malate INN …….25mg
Reference to Finished product specifications In house
The status in reference regulatory authorities Sutent 25mg capsule USFDA approved
For generic drugs (me-too status) Sutent (Pfizer Laboratories) Reg.no. 052226
Name, address of drug substance Nanjing First Pharmaceuticals Co. Ltd. China
manufacturer Room No.2303,Technical Garden B Place
Industrial University No.5 Xinmofang Road,
Nanjing, China
for both sources related to nomenclature, structure,
6 months
Pharmaceutical Equivalence and Comparative analysis Studies against the reference
Comparative Dissolution Profile product Sutent 25mg capsule (Pfizer Laboratories)
has been submitted
Container closure system of the drug product HDPE bottle (each contains 28 capsules)
Stability study data of drug product, shelf life Firm has submitted stability study data of 3
and storage conditions batches.
Accelerated stability studies have been conducted
at 40oC±2oC and 75%±5% RH for 6 months.
Evaluation by PEC:
Sr. Observations/Deficiencies/ Short- Response of the Firm
no. comings
1. Submit data of analytical Method Firm has submitted the reply of this query.
verification studies under section 3.2.S.4
repeatability (method precision) since you
have submitted validation studies GC
method for determination of residual
solvent of Sunitinib Malate.
2. Scientific justification is required that Firm has not submitted the reply of this query.
how the applied product will be
pharmaceutically equivalent to the
innovator product i.e. sutent in which the
granules are filled in capsules, while in the
applied product dry powder mixture of
active material and excipient are filled in
capsules.
3. All quality test which have been included Firm has not submitted the reply of this query.
in the finished product specification was
not performed during pharmaceutical
equivalence studies, clarification is
4. Assay limits mentioned in the Firm has not submitted the reply of this query.
pharmaceutical equivalence data is in
percentage without the clarification that
either it is the quantification of salt or its
base form. While the acceptance criteria
specified in the finished product
specification was content of sunitinib per
capsule :22.50mg to 27.
50mg.Justification is required regarding
the disparity in acceptance criteria of
assay of drug product.
5. As per the chromatographic condition Firm has not submitted the reply of this query.
specified in the procedure of dissolution
testing under section 3.2.P.2: wavelength
of UV detector was 230nm, column
temperature 25°C and retention time is 2
min (as per chromatograms) while the
chromatographic condition specified
under section 3.2.P.5.2: wavelength of
UV detector is 430nm, column
temperature 30°C and retention time is
approx.6.0 minutes. Justification is
required regarding the variation in
chromatographic condition despite using
the same dissolution medium i.e.0.1M
HCl +0.5% sodium lauryl sulphate.
6. According to the FDA’s Dissolution Firm has not submitted the reply of this query.
guidance document 2018 (same document
has been referred for innovator product)
the standard dissolution testing condition
for sunitinib malate capsule should be
“Paddle Method (USP apparatus 2) •
Stirring rate = 50 RPM • 500 mL of 0.1N
HCl in aqueous medium • No surfactant in
medium • 37±0.5°C”. While the
dissolution condition specified by the
drug product manufacturer under section
3.2.P.2 and 3.2.P.5.2 was different from
the said FDA’s guidance document.
Scientific justification is required in this
regard.
7. Justify the dissolution specification NLT Firm has not submitted the reply of this query.
70% of the labelled amount of sunitinib is
dissolved in 60 minutes since the
acceptance criteria as per the FDA
dissolution database for the innovator
product is “for immediate release solid
oral drug products containing a high
solubility drug substance the dissolution
criterion is Q=80% in 30 minutes”.
8. Same comparative dissolution profile data Firm has not submitted the reply of this query.
has been submitted for sunitix 25 capsule
and sunitix 12.5 capsule, clarification is
9. • Detailed analytical method validation Firm has submitted the revised analytical method
report is required mentioning the validation for drug product.
concentration of test solutions and their
individual results along with the results
of mean value.
• Analytical method validation protocol
specified assay method for capsule
containing granules while the
manufacturing process of drug product
evident that capsule containing dry
powder mixture of active material and
excipient has been prepared.
Justification is required that how the
validation studies performed on assay
method of capsule containing granules
be applied on capsule containing dry
powder mixture of active and
excipients.
10. Provide copy of Batch Manufacturing Firm submitted BMR, according to which 269.19
Record (BMR) for all the batches of drug gm of sunitinib Malate having potency of 99.3%
product under section 2.3.R.1.1, for which has been for manufacturing of 8,000 capsule.
stability studies data is provided in
Module 3 section 3.2. P.8.
11. Firm has already had registration of sunitinib Malate Capsule imported from Germany and
details are as follows:
Product License Holder:
Aqvida GmbH Kaiser-Wilhelm-Strabe 89 20355 Hamburg Germany.
Manufacturer:
M/s Combino Pharm (Malta) Ltd. HF 60, Hal Far Industrial Estate, Hal Far, Birzebbugia,
BBG3000, Malta.
Sunitinib Aqvida 12.5mg hard capsule (Reg.no.103778)
• Scientific justification is required that how the applied product will be pharmaceutically
equivalent to the innovator product i.e. sutent in which the granules are filled in capsules,
while in the applied product dry powder mixture of active material and excipient were filled
in capsules.
• Submission of pharmaceutical equivalence report in which all the quality parameters of
drug product specification should be included.
• Justification is required regarding the disparity in acceptance criteria of assay of drug
product, assay limits mentioned in the pharmaceutical equivalence data is in percentage
without the clarification that either it is the quantification of salt or its base form. While the
acceptance criteria specified in the finished product specification was content of sunitinib
per capsule :22.50mg to 27. 50mg.
• Scientific justification is required for using dissolution condition different from the
dissolution parameters recommended in USFDA’s innovator brand review report.
• Justify the dissolution specification NLT 70% of the labelled amount of sunitinib is dissolved
in 60 minutes since the acceptance criteria as per the FDA dissolution database for the
innovator product is “for immediate release solid oral drug products containing a high
solubility drug substance the dissolution criterion is Q=80% in 30 minutes”.
• Same comparative dissolution profile data has been submitted for sunitix 25 capsule and
sunitix 12.5 capsule, clarification is required in this regard.
248. Name, address of Applicant / Importer M/s Hakimsons Private Limited., Hakimsons House,
A-58/B, S.I.T.E, Manghopir Road, Karachi-75700,
Pakistan
Details of Drug Sale License of importer Address: A-58/B, S.I.T.E, Karachi
Status: Drug license by the way of wholesale
Name and address of marketing M/s Eugia Pharma Specialities Limited.
authorization holder (abroad) Survey No. 550, 551 & 552, Kolthur Village,
Shamirpet Mandal,
Medchal-Malkajgiri, District Medchal, Telangana,
500101, India.
Name, address of manufacturer(s) M/s Eugia Pharma Specialities Limited.
Survey No. 550, 551 & 552, Kolthur Village,
Shamirpet Mandal,
Medchal-Malkajgiri, District Medchal, Telangana,
500101, India
Name of exporting country INDIA
Detail of certificates attached (CoPP, CoPP: Firm has submitted Original Legalized CoPP
Freesale certificate, GMP certificate) (Certificate#2850/STORES/2020-06) issued by
Drugs Control Administration, Government of
Telangana, India for IRNIZET 100 (Irinotecan
Hydrochloride 20mg/ml) Concentrate for Solution for
Infusion 100mg/5ml. CoPP confirms facilities and
operations conforming to GMP as recommended by
the World Health
Organization. The certificate is valid till 19-03-2023.
GMP certificate: The firm has submitted copy of

GMP certificate for M/s Eugia Pharma Specialities
Ltd. India issued by Drugs control Administration,
Government of Telangana, India.
The certificate is valid till 19-03-2023.
Details of letter of authorization / sole Firm has submitted a copy of letter of authorization
agency agreement from M/s Aurobindo Pharma Limited, plot No.2,
Maitri Vihar, Ameerpet, Hyderabad. According to the
letter, the firm has appointed “M/s
Hakimsons Pvt. Ltd,” with principal place of business
at A-58/B, S.I.T.E, Manghopir Road, Karachi as its
Exclusive Distributor for the territory of Islamic
Republic of Pakistan. The letter was issued on 10-12-
2020 and it is valid for a period of five years.
The applicant has submitted notarized copy of letter
clarifying the relationship between Eugia pharma
specialities Limited and Aurobindo Pharma Ltd.
Eugia pharma specialities Limited is wholly owned
subsidiary company of Aurobindo Pharma Limited
with registered office address “Plot No.2, Maitrivihar,
Ameerpet, Hyderabad, Telanagana State, India.
Eugia pharma specialities Limited, with
manufacturing site address “survey no. 550, 551 &
552, kolthur village, shamirpet Mandal, Medchal -
Malkagiri District, Telangana, Indi, manufactures
oncology & Hormonal products and is one of the
manufacturing facilities associated with Aurobindo
Pharma
Limited.
☒ Importer
☐ Export sale
Dy. No. and date of submission Form-5F ; Dy. No. 23872 dated : 31/08/2021
Balanced Fee PKR 50,000/- ; 16/03/2022
Proposed proprietary name / brand name IRNIZET 40 (Irinotecan Hydrochloride)
Concentrate for Solution for Infusion 40mg/2ml
Strength/concentration of drug of Active Each mL contains
Pharmaceutical ingredient (API) per unit Irinotecan Hydrochloride ………20 mg
Pharmaceutical form of applied drug Concentrate for Solution for Infusion
Pharmacotherapeutic Group of (API) Antineoplastic agents, other antineoplastic agents
(ATC code: L01XX19)
specifications
Proposed Pack size 1’s vial
The status in reference regulatory CAMPTOSAR Injection for Infusion 40mg/2ml
authorities by PFIZER INC (USFDA approved)
For generic drugs (me-too status) Campto Injection 40mg/2ml of M/s Pfizer (Reg #
021127)
Irinotecan Injection 40mg/2ml of M/s Novartis
(Reg#066186)
The firm has summarized information of drug product
manufacturing process and process control, process
validation protocols, control of excipients, control of
Name, address of drug M/s Laurus Labs Limited,
substance manufacturer Plot No. 21, Jawaharlal Nehru Pharma City,
Parawada, Visakhapatnam-531021
Andhra Pradesh, India Tel: +91-
891-3061222
Fax: +91-891-3061270
(Conditions & duration of Stability API at accelerated and real time conditions. It was
studies) concluded that Irinotecan HCl Trihydrate is stable up
to 6 months under accelerated conditions (40 oC ±2
o
C/75%± 5% RH) & 60 months under long term
conditions (25oC ±2oC / 60% ± 5% RH)
and process control, process validation report, control
of excipients, control of drug product, specifications,
Pharmaceutical Equivalence and The firm has submitted physicochemical evaluation of
Comparative Dissolution Profile CAMPTO 20 mg/mL concentrate for solution for
infusion., (batch # M86531) of M/s Pfizer Limited and
also submitted finished product evaluation of
Irinotecan 20 mg/ml concentrate for solution for
infusion. [40 mg/2 mL] (batch # EIH1810F) of Eugia
Pharma Specialities Limited.
Analytical method validation/verification Firm has submitted Assay Method Validation
of product Protocols along with Reports of Irinotecan 20 mg/ml
concentrate for solution for infusion. [40 mg/2 mL]
Finished product as well as for Active substance.
In-house analytical test methods were developed to
determine the identification (By HPLC), Assay (By
HPLC), Related substance (By HPLC), R-Enantiomer
content (by HPLC), and color absorbance (By UV) in
drug product and methods have been validated as per
the ICH.
Container closure system of the drug Vial size and type: Glass Vial Tubular Type-I, 6R
product Amber BB vial with 13 mm Neck
Rubber stopper: Dark Grey bromo butyl rubber
stopper, 13mm
Flip off seal: Al. Seal with PP disc, 13 mm red color.
Stability study data of drug product, shelf Firm has submitted stability study data of 3 batches of
life and storage conditions Irinotecan HCl 20mg/ml, concentrate for solution for
Infusion (40mg/2ml)
The accelerated stability study data is conducted at 40
o
C ±2 oC/ 75%± 5% RH for 06 months. The real time
stability study data is conducted at 30oC ±2oC / 65%
± 5% RH for 24months. (Invert)
Batch No. Batc Mfg. Initiation
h Date date
size
EIH1810-A 10 L 04-2018 28-08-2018
EIH1811-A 30 L 04-2018 19-06-2018
EIH1812-A 30 L 05-2018 19-06-2018
Evaluation by PEC:
S. Observations/Deficiencies/ Short- Response of the Firm
no. comings
1. Clarify the marketing status of applied Firm submitted the approval status of applied
product in the exporting country, since formulation in the reference regulatory authorities
the submitted free sale certificate and and inform that the applied formulation is
CoPP evident that the applied product available in the market of Belgium & USA, instead
has not been freely available in the of inform about the marketing status of applied
market of country of origin and product in the exporting country.
according to the free sale certificate,
market status of applied product is in
export only.
2. Provide the valid free sale certificate, Firm submitted the free sale certificate that is valid
since the validity of submitted certificate uptill 02/02/2025, in which marketing status of
was up till 25/06/2021. applied product is for export only.
Decision: Deferred for clarification of marketing status of applied finished product in the
exporting country, since the submitted free sale certificate and CoPP evident that the applied
product has not been freely available in the market of country of origin.
249. Name, address of Applicant / Importer Name: The Searle Company Limited
Address: Head Office:
Section-D, 2nd Floor One IBL Centre, Plot # 1, Block
7 & 8, (DMCHS), Tipu Sultan Road, Off, Shahrah-e-
Faisal, Karachi.
Factory:
The Searle Company Limited, F-319 SITE Karachi,
Pakistan.
Address: Section-D, 2nd Floor One IBL Centre, Plot #
1, Block 7 & 8, (DMCHS), Tipu Sultan Road, Off,
Shahrah-e-Faisal, Karachi.
Address of Godown:
1) Plot No Section 1 F-2/Q Site Karachi.
Validity: 15-05-2021.
Name and address of marketing LABORATORIOS LEÓN FARMA, SA
authorization holder (abroad) C/ La Vallina, s/n, Polígono Industrial Navatejera,
Villaquilambre 24008 (León) SPAIN
Name, address of manufacturer(s) LABORATORIOS LEÓN FARMA, SA
C/ La Vallina, s/n, Polígono Industrial Navatejera,
Villaquilambre 24008 (León) SPAIN
Name of exporting country SPAIN
Detail of certificates attached (CoPP, CoPP: Firm has submitted original, legalized copy of
Freesale certificate, GMP certificate) CoPP certificate (No.2020/02446) dated 11/27/2018
issued by Spanish Agency for Medicines and Health
Products. The CoPP confirms free sale status of the
product in exporting country as well as GMP status of
the manufacturing site through periodic inspection
every 3 years.
The name of importing country on CoPP is mentioned
as Spain.
Details of letter of authorization / sole Firm has submitted copy of letter of Authorization
agency agreement from LABORATORIOS LEÓN FARMA, SA. The
letter species that the manufacturer appoints The
Searle Company Limited to register their products in
Pakistan.
☒ Importer
☐ Export sale
For imported products, specify one the ☒ Finished Pharmaceutical Product Import
purpose only
The proposed proprietary name / brand Urisolin Plus Capsules 0.5mg + 0.4mg
name
Strength / concentration of drug of Active Each Capsule contains:
Pharmaceutical ingredient (API) per unit Dutasteride …… 0.5mg
Tamsulosin Hydrochloride… 0.4mg
Pharmaceutical form of applied drug Capsule, Hard
Pharmacotherapeutic Group of (API) Alpha-adrenoreceptor antagonists (ATC code:
G04CA52)
Reference to Finished product Ph Eur
specifications
Proposed Pack size As per DPC
The status in reference regulatory JALYN® Capsules (Approved by USFDA)
authorities
For generic drugs (me-too status) Getz Pharma Pakistan (Pvt.) Ltd
Tamsolin Plus
Dutasteride 0.5mg + Tamsulosin hydrochloride 0.4mg
Name, address of drug substance Dutasteride: Aurobindo Pharma
manufacturer Tamsulosin hydrochloride: Zentiva
and controls, impurities, specifications, analytical
procedures and its validation, batch analysis and
substance.
Stability Studies of Drug Substance Dutasteride:
(Conditions & duration of Stability studies) Firm has submitted stability study data of 3 batches of
API at accelerated as well as real time conditions. The
real time stability data is conducted at 25°C ± 2ºC &
RH 60%+/-5% and Accelerated time stability study is
conducted at 40°C ± 2ºC & RH 75%+/- 5%. The
stability study data is till 24 months.
Tamsulosin hydrochloride:
API at accelerated as well as real time conditions. The
real time stability data is conducted at 25°C ± 2ºC &
RH 60%+/-5% and 40°C ± 2ºC & RH 75%+/- 5%. The
stability study data is till 36 months.
Pharmaceutical Equivalence and Pharmaceutical Equivalence and CDP has been
Comparative Dissolution Profile performed against the reference product Name:
Duodart® 0.5/0.4 mg hard capsules
Batch nº: 13692073B
Manufacturer: Glaxo Smith Kline Laboratories
Expiry date: July 2017
Analytical method validation/verification Firm has submitted analytical method validation
of product studies for the applied product.
Container closure system of the drug white HDPE bottle with silica gel desiccant contained
product in a white cap
Stability study data of drug product, shelf Firm has submitted stability study data of 3 batches
life and storage conditions The accelerated stability study data is conducted at
40oC ±2oC / 75% ± 5% RH for 6 months. The real time
stability study data is conducted at 30oC ±2oC / 75% ±
5% RH for 12 months.
Evaluation by PEC:
Firm submitted the differential fee of Rs.50,000/- deposit slip no. 41090716 dated 22-06-2022.
storage facility.
250.Name, address of Applicant / Importer M/s Highnoon Laboratories Ltd.
17.5km, Multan Road, Lahore-53700, Pakistan.
Address:
Address of Godown:
1. Situated at 18km Multan Road, Lahore (Behind
Highnoon Laboratories Limited, Opposite Star Food
Cold Storage).
251. Situated at 19km Multan Road (Din

Muhammad Town, Chung) Lahore
Validity: 12-Sep-2022
Renewal: Firm has submitted a receipt of renewal, but
it does not contain any date
Name and address of marketing M/s Highnoon Laboratories Ltd.
authorization holder (abroad) 17.5km, Multan Road, Lahore-53700, Pakistan.
Name, address of manufacturer(s) Cipla Limited, Maharashtra India.
Plot D-7, D-22, D-27 MIDC Industrial Area,
Kurkumbh Village, Taluka-Daund, Pune,
Maharashtra 413802, India
Name of exporting country India
Detail of certificates attached (CoPP, CoPP: Firm has submitted an original, legalized copy
Freesale certificate, GMP certificate) of CoPP certificate (No.
COPP/CERT/PD/110147/2022/11/39010/190011)
dated 30-01-2022 issued by Food and Drug
Administration, M.S. Bandra-kurla complex, Bandra
(E), Mumbai-400 051. Mahrashtra, India for
Cipmolnu 200mg Capsule. The CoPP confirms free
sale status of the product in exporting country as well
as GMP status of the manufacturing site through
periodic inspection every year.
The name of importing country on CoPP is mentioned

as Pakistan. Furthermore, the CoPP was valid till 21-
05-2022.
Details of letter of authorization / sole Firm has submitted copy of Originally Notarized letter
agency agreement of Authorization from Cipla Limited, Maharashtra
India.
The letter species that the manufacturer appoints M/s
Highnoon Laboratories Ltd. to register their products
in Pakistan. The authorization letter is valid till 03-03-
2023.
☒ Importer
☐ Export sale
purpose only
Dy. No. and date of submission Dy. No. 11466 12-05-2022
The proposed proprietary name / brand Cipmolnu 200mg Capsule
name
Strength / concentration of drug of Active Each capsule contains:
Pharmaceutical ingredient (API) per unit Molnupiravir…….200 mg
Pharmaceutical form of applied drug White to off- white powder filled in size ‘0’ capsule
with light blue opaque cap and body.
Pharmacotherapeutic Group of (API) Antiviral
Reference to Finished product Innovator
specifications
Proposed Pack size 1’s, 5’s, 7’s, 10’s, 12’s, 28’s, 30’s, 40’s, 50’s, 60’s,
100’s, 120’s
The status in reference regulatory Lagevrio 200 mg hard capsules MHRA approved
authorities
Name, address of drug substance M/s Cipla Limited-Kurkumbh
manufacturer Plot No. D-7, D-27, D-22 MIDC Industrial Area,
Kurkumbh Village, Taluka-Daund, District-Pune
(Maharashtra)-413 802, India.
Module-III Drug Substance: The firm as submitted detail of nomenclature,
process and controls, tests for related substances
(impurity A, MOL-Hydroxylamine & unspecified),
Stability Studies of Drug Substance Stability study conditions:
(Conditions & duration of Stability studies) Real time: 30°C ± 2°C / 65% ± 5%RH for 1 year
Batches: (LDX210049, LDX210055, LDX210056)

Module-III Drug Product: The firm has submitted detail of manufacturers,
product.
Comparative Dissolution Profile against the brand leader that is Molnupiravir Capsules
200 mg by Merck Pharma by performing quality tests
dosage form).

is Molnupiravir Capsules 200 mg by Merck Pharma in
Acid media (pH 1.0-1.2) & Phosphate Buffer (pH 6.8).
Analytical method validation/verification of Method validation studies have submitted including
product linearity, range, accuracy, precision, specificity.
Container closure system of the drug 40’s bottle pack
product
Stability study data of drug product, shelf Firm has submitted stability study data of 3 batches
life and storage conditions The accelerated stability study data is conducted at
40oC ±2oC / 75% ± 5% RH for 6 months. The real time
stability study data is conducted at 30oC ±2oC / 75% ±
5% RH for 1 year.
KA1230
Batch No. KA12304 KA12305
6
Batch Size 30,000 30,000 30,000
Manufacturing
07-2021 07-2021 07-2021
Date
13-08- 13-08- 13-08-
Date of Initiation
2021 2021 2021
Evaluation by PEC:
S.no. Observations/Deficiencies/ Short-comings Reply of the Firm
1. Provide readable copy of valid Drug sale Submitted
license.
2. Provide stability data of drug substance Firm submitted the 6th month accelerated
performed at accelerated and long term and 1 year real time stability data of drug
stability condition till the claimed shelf substance.
life/retest date.
3. Provide the stability data of three trial Firm submitted the 6th month accelerated
batches/commercial batches till the claimed and 1 year real time stability data of drug
shelf life, since you have submitted only substance.
three months stability data of drug product.
• Submission of complete stability data of drug substance and drug product till the claimed shelf
life/retest date as per zone IV conditions.
• Regulatory status of approval of applied formulation by reference regulatory authority by way
of routine procedure of market authorisation.
252. Name, address of Applicant / Importer Biocare Pharmaceutica.
Address:- 807 Shadman-1, Lahore
Address: 807 Shadman-1, District Lahore.
Address of Godown: First floor B-C, Street No. 3,
Near LGS School, Shah Jamal District Lahore.
Validity: 17-04-2022.
Renewed/New DSL: Drug sales License is

renewed. New Drug sales License is attached for
DRAP reference. (New License No. 05-352-0063-
032069D) , Validity:- 17.04.2027.
Name and address of marketing authorization
holder (abroad) License Holder/Supplier: PT DEXA MEDICA.
Address:- Jalan Jenderal Bambang Utoyo No. 138,

Palembang 30115, Indonesia, Tel:- (+62-21) 7454
111. Telephone : (+62-21) 7454 111
Name, address of manufacturer(s) Manufactured By:- PT Ferron Par
Pharmaceuticals.
Address Manufacturing site Jababeka Industrial

Estate I, Jl. Jababeka VI Blok J-3
Cikarang Bekasi 17520, Indonesia,
Telephone: +62 21 898 33333
Name of exporting country Indonesia
Detail of certificates attached (CoPP, Freesale CoPP: Firm has submitted original, legalized copy
certificate, GMP certificate) of CoPP with certificate No.
RG.01.05.32.321.07.21.2976, dated July 6, 2021
issued by National Agency of Drug and Food
Control, Indonesia. The CoPP confirms free sale
status of the product in exporting country as well
as GMP status of the manufacturing site through
periodic inspection every year. CoPP validity is
July 6, 2023 based upon its 2 year validity. The
name of importing country on CoPP is mentioned
as Pakistan.
Embassy Attested/Legalized GMP is also attached.

GMP Validity is March, 13, 2023.
Details of letter of authorization / sole agency Firm has submitted copy of legalized distribution
agreement agreement signed by both parties Biocare
Pharmaceutica & PT Dexa Medica. Agreement
clearly mention Aboard License Holder Dexa
Medica (Indinesia) appoints M/s Biocare
Pharmaceutica to register/market/sell/Distribute
their product Granon (Granisetron HCL) 1 mg/1ml
Inj. in Pakistan. Agreement validity is 10 years
with additional 5 year renewal clause.
☒ Importer
☐ Export sale
purpose only
Dy. No. and date of submission Dy. No. 31639 : 17-11-2021
Details of fee submitted PKR 150,000 /-: Slip # 9327411064,
Date:- 13-11-2021
The proposed proprietary name / brand name GRANON
Strength / concentration of drug of Active Each mL of contains Granisetron Hydrochloride
Pharmaceutical ingredient (API) per unit equivalent to Granisetron 1 mg.
Pharmaceutical form of applied drug Solution for injection Clear, colorless solution.
Pharmacotherapeutic Group of (API) Alimentary Tract and Metabolism,
Antiemetics and Antinauseants
Proposed Pack size 5 Ampoules per Pack (Box 5 Ampoules)
Proposed unit price Rs 554/Ampoule.
Rs. 2770 for 5 ampoules Box
The status in reference regulatory authorities Granisetron HCl 1 mg/1ml (1mg/ml) is
UKMHRA, TGA (Australia) and EMA (European
Medicine Agency) approved 5-HT3 receptor
antagonist used as an antiemetic to prevent/treat
nausea and vomiting caused by chemotherapy and
radiation therapy and to prevent and treat nausea
and vomiting after surgery in adults. It is currently
actively market in United Kingdom (UK),
Australia and in European countries like Germany,
France Finland, Estonia, Greece, Ireland, Latvia
and Italy etc.
For generic drugs (me-too status) Mfr. Name/Importer/Local:- A.J Mirza Pharma
(PVT) LTD,
Brand:- Granicip, Strength:- 1mg/1ml,
Composition:- Granisetron Hydrochloride, Reg.
No. 052261,
Dosage Form:- Solution in Ampoule for injection
&
Price (MRP):- Register but not launch in Pakistan
market.
Name, address of drug substance manufacturer Hubei Haosun Pharmaceutical Co., Ltd.
Address No. 20, Juxian Road, Gedian Economic &

Technology Development Area, Hubei, 436070, P.
R. China
for both sources related to nomenclature, structure,
(Conditions & duration of Stability studies) of API at accelerated as well as real time
conditions. The 6 months accelerated study is
complete for 3 batches at 40±2 °C/75±5%RH. The
real time 3 batches stability data is conducted at
25±2°C/60±5%RH. The real time stability study
data is till 48 months.
Pharmaceutical Equivalence and Comparative Pharmaceutical equivalence has been established
Dissolution Profile by conducting all the quality tests against the
reference original brand Kytril (Granisetron)
1mg/1ml injection, batch number F0024F71,
produced by Roche,
Switzerland.
Container closure system of the drug product Granon (GranisetronHcl) 1 mg/1ml solution for
injection is filled into Type I clear glass
ampoule 1 mL.
Stability study data of drug product, shelf life
and storage conditions • 24 months real time stability data at 30°C
± 2°C / 75% ± 5%RH of 03 batches (Zone IVB)
is Submitted.
• 06 month accelerated stability data
40°C ± 2°C / 75% ± 5%RH of 03 batches is
submitted.
Evaluation by PEC:
Sr.no. Observations/Deficiencies/ Short-comings Reply of the Firm
1. Provide specification and detailed analytical Firm submitted the specification and detailed
procedure used for testing of drug substance analytical procedure used for testing of drug
by drug product manufacturer, since the substance by drug substance manufacturer
submitted details were of drug product and drug product manufacturer.
manufacturer.
2. Pharmaceutical equivalence of granon Firm replied that kyril injection 0.1% is a
3mg/3ml injection has been performed product containing granisetron hydrochloride
against Kytril Injection 0.1% as evident from
equivalent to 3mg of granisetron free base in
the submitted document, justify to perform 3 ml or equivalent to equivalent to 1mg of
equivalence study with the reference productgranisetron free base in 1ml where it is the
that is different in strength and volume from
same concentration with Granon 1mg/ml and
that of applied product. Granon 3mg/3ml Injection, only different in
filling volume.
3. Clarification is required either the product Firm clarified that product comply USP
comply USP specification or in-house specification, sone additional test were
specification. performed in accordance with in-house
specification.
storage facility.
253. Name, address of Applicant / Importer Biocare Pharmaceutica. Address:-
807 Shadman-1, Lahore
Validity: 17-04-2022.
Renewed/New DSL: Drug sales License is renewed.

New Drug Sales License is attached for DRAP
reference. (New License No. 05-352-0063-
032069D) , Validity:- 17.04.2027.
Name and address of marketing
authorization holder (abroad) License Holder/Supplier: PT DEXA MEDICA.
Address: - Jalan Jenderal Bambang Utoyo No. 138,

Palembang 30115, Indonesia, Tel: - (+62-21) 7454
111. Telephone : (+62-21) 7454 111
Name, address of manufacturer(s) Manufactured By:- PT Ferron Par Pharmaceuticals.
Address Manufacturing site Jababeka Industrial

Estate I, Jl. Jababeka VI Blok J-3
Cikarang Bekasi 17520, Indonesia,
Telephone: +62 21 898 33333
Detail of certificates attached (CoPP, CoPP: Firm has submitted original, legalized copy
Freesale certificate, GMP certificate) of CoPP with certificate No.
RG.01.05.32.321.05.21.2848, dated May 20, 2021
status of the product in exporting country as well as
GMP status of the manufacturing site through
periodic inspection every year. CoPP validity is
May 20, 2023 based upon its 2-year validity. The
name of importing country on CoPP is mentioned as
Pakistan.
GMP Validity is March, 13, 2023.
Details of letter of authorization / sole Firm has submitted copy of legalized distribution
agency agreement agreement signed by both parties Biocare
Medica (Indinesia) appoints M/s Biocare
Pharmaceutica to register/market/sell/Distribute
Inj. in Pakistan. Agreement validity is 10 years with
additional 5 year renewal clause.
☒ Importer
☐ Export sale
purpose only
Details of fee submitted PKR 150,000 /-: Slip # 17375816,
Date:- 13-11-2021
The proposed proprietary name / brand GRANON
name
Strength / concentration of drug of Active Each 3 ml ampoule contains a total content of 3 mg
Pharmaceutical ingredient (API) per unit granisetron as the hydrochloride in 3 ml of a sterile
solution.
Pharmaceutical form of applied drug Solution for injection Clear, colorless solution.
Pharmacotherapeutic Group of (API) Alimentary Tract and Metabolism,
Antiemetics and Antinauseants
Proposed Pack size 5 Ampoules per Pack (Box 5 Ampoules)
Proposed unit price Rs 850/Ampoule.
Rs. 4250 for 5 ampoules Box
The status in reference regulatory Granisetron HCl 3 mg/3ml (1mg/ml) is UKMHRA,
authorities TGA (Australia) and EMA (European Medicine
Agency) approved 5-HT3 receptor antagonist used
as an antiemetic to prevent/treat nausea and
vomiting caused by chemotherapy and radiation
therapy and to prevent and treat nausea and
vomiting after surgery in adults. It is currently
actively market in United Kingdom (UK), Australia
and in European countries like Germany, France
Finland, Estonia, Greece, Ireland, Latvia and Italy
etc.
(Evidences Attached/along with approved Leaf
Inserts: - Please refer to Module 1. Page # 271-323
of CTD dossier).
For generic drugs (me-too status) Mfr. Name/Importer/Local: - CCL Pharmaceuticals
(Pvt)., Ltd,
Brand: - Graniset, Strength: - 3mg/3ml,
Composition: - Granisetron Hydrochloride, Reg.
No. 048027,
Dosage Form:- Solution in Ampoule for injection
Name, address of drug substance Hubei Haosun Pharmaceutical Co., Ltd.
manufacturer Address No. 20, Juxian Road, Gedian Economic &
Technology Development Area, Hubei, 436070, P.
R. China
The 6 months accelerated study is complete for 3
batches at 40±2 °C/75±5%RH. The real time 3
batches stability data is conducted at
Pharmaceutical Equivalence and Pharmaceutical equivalence has been established by
Comparative Dissolution Profile conducting all the quality tests against the reference
original brand Kytril (Granisetron) 3mg/3ml
injection, batch number F0024F71, produced by
Roche,
Switzerland, Roche, imported by PT Boehringer
Ingelheim
Container closure system of the drug product Granon (Granisetron Hcl) 3 mg/3ml solution for
injection is filled into Type I clear glass
ampoule 5 mL.
Stability study data of drug product, shelf life
and storage conditions • 4 batches Accelerated and Long-term stability
data is submitted.
• 36 months real time long term stability data at

30°C ± 2°C / 75% ± 5%RH (ZONE IVB) of 2
batches and 24 months long term real time
stability data 02 batches at 30°C ± 2°C / 75% ±
5%RH (Zone IVB) is Submitted. Overall 4
batches long term stability data is submitted. Firm
has claim 24 months shelf life based upon its
Long term real time 4 batches ZONE IVB
stability data.

submitted.
Evaluation by PEC:
Sr.no. Observations/Deficiencies/ Short-comings Reply of the Firm
1. Provide specification and detailed analytical Firm submitted the specification and detailed
procedure used for testing of drug substance analytical procedure used for testing of drug
by drug product manufacturer, since the substance by drug substance manufacturer
submitted details were of drug product and drug product manufacturer.
manufacturer.
2. Pharmaceutical equivalence of granon Firm replied that kyril injection 0.1% is a
3mg/3ml injection has been performed product containing granisetron hydrochloride
against Kytril Injection 0.1% as evident from equivalent to 3mg of granisetron free base in
the submitted document, justify to perform 3 ml or equivalent to equivalent to 1mg of
equivalence study with the reference product granisetron free base in 1ml where it is the
that is different in strength and volume from same concentration with Granon 1mg/ml and
that of applied product. Granon 3mg/3ml Injection, only different in
filling volume.
comply USP specification or in-house specification, some additional test were
specification. performed in accordance with in-house
specification.
storage facility.
254. Name, address of Applicant / Importer Biocare Pharmaceutica. Address:- 807 Shadman-1,
Lahore
Validity: 17-04-2022.
Renewed/New DSL: Drug sales License is renewed.
New Drug sales License is attached for DRAP
reference. (New License No. 05-352-0063-
032069D) , Validity:- 17.04.2027.
Name and address of marketing License Holder/Supplier: PT DEXA MEDICA.
authorization holder (abroad) Address:- Jalan Jenderal Bambang Utoyo No. 138,
111. Telephone : (+62-21) 7454 111
Name, address of manufacturer(s) Manufacturer: PT DEXA MEDICA.
Address:- Jalan Jenderal Bambang Utoyo No. 138,
111. Telephone : (+62-21) 7454 111
Detail of certificates attached (CoPP, CoPP: Firm has submitted original, legalized copy
Freesale certificate, GMP certificate) of CoPP with certificate No.
RG.01.05.32.321.05.21.2849, dated May 20, 2021
status of the product in exporting country as well as
GMP status of the manufacturing site through
periodic inspection every year. CoPP validity is May
20, 2023 based upon its 2 year validity. The name of
importing country on CoPP is mentioned as
Pakistan.
GMP Validity is April 5, 2023.
Details of letter of authorization / sole Firm has submitted copy of legalized distribution
agency agreement agreement signed by both parties Biocare
Medica (Indonesia) appoints M/s Biocare
Pharmaceutical to register/market/sell/Distribute
Inj. in Pakistan. Agreement validity is 10 years with
additional 5 year renewal clause.
☒ Importer
☐ Export sale
purpose only
Details of fee submitted PKR 150,000 /-: Slip # 474738766,Date:- 13-11-
2021
The proposed proprietary name / brand GRANON
name
Strength / concentration of drug of Active Each film-coated tablet contains granisetron
Pharmaceutical ingredient (API) per unit hydrochloride equivalent to granisetron 1 mg.
Pharmaceutical form of applied drug Film-coated tablet White, round and shallow convex
tablet, diameter 6
mm. Side I DEXA and side II unmarked
Pharmacotherapeutic Group of (API) Alimentary Tract and Metabolism, Antiemetics and
Antinauseants
Proposed Pack size 10 Tablets per Pack (10’S)
Proposed unit price Rs 250 per Tablet.
Rs. 2500 for 10’S Pack.
The status in reference regulatory authorities Granisetron HCl 1 mg film coated Tablet is
UKMHRA, TGA (Australia) and EMA (European
Medicine Agency) approved 5-HT3 receptor
antagonist used as an antiemetic to prevent/treat
nausea and vomiting caused by chemotherapy and
radiation therapy and to prevent and treat nausea and
vomiting after surgery in adults. It is currently
actively market in United Kingdom (UK), Australia
and in European countries like Germany, France
Finland, Estonia, Greece, Ireland, Latvia and Italy
etc.
(Evidences Attached/along with approved Leaf
Inserts: - Please refer to Module 1. Page # 181-232
of CTD dossier).
For generic drugs (me-too status) Mfr. Name/Local: - CCL Pharmaceuticals (Pvt).,
Ltd,
Brand: - Graniset, Strength: - 1 mg,
Composition: - Granisetron Hydrochloride,
Reg. No. 048026, Dosage Form: - Film Coated
Tablet &
Price (MRP): - Rs. 2650/pack 10 Tablets (10'S) .
Name, address of drug substance Qilu Pharmaceutical Co., Ltd.
manufacturer Address:- No. 243 Gong Ye Bei Road, Jinan,
Shandong Province 250100, P. R. China
The 6 months accelerated study is complete for 3
batches at 40±2 °C/75±5%RH. The real time 3
batches Zone IVA stability data is conducted at
Overall firm has provided 6 batches Zone IVA
(30±2°C/65±5%RH) 24 months real time long-term
API Stability data along with 6 months 4 batches
Accelerated stability data at 40±2 °C/75±5%RH.
Pharmaceutical Equivalence and Pharmaceutical equivalence has been established by
Comparative Dissolution Profile conducting all the quality tests against the reference
original brand Kytril (Granisetron) 1 mg film coated
tablet, batch number M1000B71, produced by
Roche,
Nederland, B.V. Detail Comparative Dissolution
Profile is also provided by manufacturer Dexa
Medica.
Container closure system of the drug product Granon (Granisetron Hcl) 1 mg tablet is Packed in
polycellonium strip.
Stability study data of drug product, shelf life 4 batches Accelerated and Long term stability data
and storage conditions is submitted.
• 36 months real time long term stability data at
30°C ± 2°C / 75% ± 5%RH (ZONE IVB) of 2
batches and 24 months long term real time
stability data 01 batches at 30°C ± 2°C / 75% ±
5%RH (Zone IVB) is Submitted. Overall 4
batches long term stability data is submitted. One
ongoing real time Zone IVB stability data of 12
months is also submitted by firm. Firm has claim
24 months shelf life based upon its complete
Long term real time 3 batches ZONE IVB
stability data.
submitted.
Evaluation by PEC:
Sr. Observations/Deficiencies/ Short- Reply of the Firm
no. comings
1. Provide specification and detailed Firm submitted the specification and detailed
analytical procedure used for testing of analytical procedure used for testing of drug
drug substance by drug product substance by drug substance manufacturer and
manufacturer, since the submitted details drug product manufacturer.
were of drug product manufacturer.
comply USP specification or the or the specification, some additional test were performed
applied product claimed in-house in accordance with in-house specification.
specification.
3. Scientific justification is required for Firm replied that Granon film coated tablet is refer
setting the widened time point window i.e. to USP monograph with a limit of T
till 30 minutes, when the drug release 30minutes≥75%(Q).The purpose of specifying
more than 85% within 15 minutes as dissolution limits is to ensure batch-to- batch
evident from the CDP report and the consistency within arrange which gurantess
submitted stability data also revealed that acceptable biopharmaceutical performance in vivo.
more than 95% drug release in 30 minutes.
storage facility.
Cases of Local Manufacturing received on Form 5-F

255. Name, address of Applicant / Marketing M/s NABIQASIM INDUSTRIES (PVT)
Authorization Holder LTD.
17 / 24, Korangi Industrial Area,
Karachi – Pakistan.
Telephone: + (21) 32213886, 32633590,
UAN 111-742-762
Name, address of Manufacturing site. M/s NABIQASIM INDUSTRIES (PVT)
LTD.
Telephone: + (21) 32213886, 32633590,
UAN 111-742-762
☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand name Roviros Eze Tablets 5mg + 10mg
Strength / concentration of drug of Active Each film-coated tablet contains:
Pharmaceutical ingredient (API) per unit Rosuvastatin USP……..…5mg
Ezetimibe USP…………..10mg
(Innovator’s Specs.)
Pharmaceutical form of applied drug Pink color round shape film coated tablet,
one side engraved NQ and other side
engraved bisect line.
Pharmacotherapeutic Group of (API) HMG-CoA reductase inhibitors in
combination with other lipid modifying
agents
Reference to Finished product specifications Innovator’s Specs.
The status in reference regulatory authorities Roszet Tablets (Rosuvastatin + Ezetimibe) is
registered and being marketed by Althera
Pharmaceuticals LLC (Approved by US
FDA, United States of America).
For generic drugs (me-too status) Rovista Eze Tablets 5/10mg by M/s Getz
Pharma (Pvt.) Ltd., (Reg. No. 073716)
Each film-coated tablet contains:
Rosuvastatin Calcium eq. to
Rosuvastatin…5mg
Ezetimibe………………………………….1
0mg
GMP status of the Finished product New GMP Certificate granted on
Tablet (General & Antibiotic), Capsule
(General & Cephalosporin), Dry Powder for
Suspension (General Antibiotic
&Cephalosporin), Oral Liquid (Syrup)
(Non-Antibiotic & Antibiotic), Cream /
Ointment / Lotion (Non-Antibiotic &
Antibiotic & Steroids), Eye & Ear Drops
(Non-Antibiotic & Antibiotic & Steroids),
Liquid Enema (General), Sachet (General),
Small Volume Lyophilized Injectable (Non-
Antibiotic, Antibiotic), Gel & Tablet
(Hormones) sections approved.
Name and address of API manufacturer. Rosuvastatin Calcium:
RUYUAN HEC PHARM CP., LTD.
Xiaba Development Zone, RUtuan Country,
Shaoguan City, Guangdong Province,
P.R.China.
Ezetimibe:
Saptagir Laboratories Pvt. Ltd.
Sy.No. Parts of 27, 46 & 50 to 56,
Ananthasagar (Vill), Chegunta (Mandal),
Medak (Dist.), Telangana, India
verification / validation, batch analysis and
Module III (Drug Substance) Rosuvastatin Calcium:
Monograph of Rosuvastatin Calcium is
present is as per USP specifications. The
firm as submitted detail of nomenclature,
related compunds (Rosuvastatin related
compound A, Rosuvastatin diastereomers,
Rosuvastatin ketone, Rosuvastatin lactone,
Rosuvastatin dehydro analog, Enantiomeric
purity, Any unspecifies impurity, total
Impurities), specifications, analytical
Ezetimibe:
Monograph of Ezetimibe is present is as per
USP specifications. The firm as submitted
process and controls, tests for related
substances ({Desfluoroaniline analog, o-
Fluorobenzene isomer, m-Fluoroaniline,
Ezetimibe ketone, Unspecified Impurity,
Total Impurities}, {Organic Impurities
[Procedure-2 by HPLC*] S,S,S- Ezetimibe,
R,R,R-Ezetimibe, R,R,S-Ezetimibe, S,S,R-
Ezetimibe, R,S,R-Ezetimibe, Total chiral
impurities, Total Impurities} specifications,
substance.
Stability studies Rosuvastatin Calcium:
months
Batches: RSV-201704101, RSV-
201704102, RSV-201705101
6 months
201704102, RSV-201705101
Ezetimibe:
months
Batches: EI0011117, EI0021217,
EI0031217
6 months
Batches: EI0011117, EI0021217,
EI0031217
specifications, analytical procedure
(including dissolution testing at acidic and
buffer medium) and its validation studies,
product.
dissolution profile established against the brand leader Rolip
Eze Tablet 5/10mg is registered and being
marketed by Hilton Pharma (Pvt.) Ltd., by
performing quality tests (Description,
Identification, Dissolution and Assay)
brand that is Rolip-Eze Tablet 5/10mg
(Rosuvastatin Calcium 5mg + Ezetimibe
10mg) by Hilton Pharma (Pvt.) Ltd., in Acid
media (pH 1.2), Acetate Buffer (pH 4.5 & pH
4.5 with 0.45% SLS {QC release media for
Ezetimibe}) & Phosphate Buffer (pH 6.8).
The values for f1 and f2 are in the acceptable
range.
product including linearity, range, accuracy,
precision, specificity.
Manufacturer of API Rosuvastatin Calcium:
Shaoguan City, Guangdong Province, P.R.China.
Ezetimibe:
Sy.No. Parts of 27, 46 & 50 to 56, Ananthasagar (Vill), Chegunta (Mandal),
API Lot No. Rosuvastatin Calcium
RSV-(RD)202104602
Ezetimibe:
EZ0160621
Description of Pack
(Container closure Alu-Alu blister packed in unit carton (1×10’s).
system)
Batch No. 485DS01 485DS02 485DS03
No. of Batches 03
7. Reference of previous approval of Submitted.
firm (if any)
8. Approval of API/ DML/GMP certificate of Rosuvastatin Calcium:
API manufacturer issued by concerned Copy of GMP certificate no
regulatory authority of country of origin. DE_BE_01_GMP_2019_0042 issued by
State Office for Health and Social Affairs,
Germany valid till 29/11/2022.
Ezetimibe:
Copy of GMP certificate no. 82079/TS/2022
issued by Drugs Control Administration,
Government of Telangana valid till
22/02/2023.
9. Documents for the procurement of API with Rosuvastatin Calcium:
approval from DRAP (in case of import). Copy of invoice no WIS210069 dated 16-06-
2021 duly attested by Assistant Director,
DRAP, Karachi on 30-06-2021 was
provided.
Ezetimibe:
Copy of Invoice No. 2122/SL/031 dated 20-
07-2021 duly attested by Assistant Director,
provided.
chromatograms,
Raw data sheets, COA, summary data sheets
etc.
S. Sections Observations/Deficiencies/ Short- Reply of the Firm
no. comings
1. 3.2. S.4.4 COA of Rosuvastatin calcium by Firm submitted the reply that the
drug substance manufacturer evident COA of drug substance also complies
that the drug substance meet the USP specification and the analytical
requirements of A-SPC-RSV-A procedure by drug substance also
instead of USP specification, justify, complied USP monograph. However
how the drug product manufacturer the chloride content is not included in
use USP specifications for quality the COA of drug substance by drug
testing of drug substance as substance manufacturer.
mentioned on their submitted raw
material analysis report, when the
drug substance did not conform to
USP specification.
2. According to the formulation development data, the applied product is bilayer film
coated tablet, while the review report of innovator brand specifies that the roszet
tablet is film coated pink color biconvex shaped tablet. Justify, how the applied
product will be pharmaceutically equivalent to the innovator brand.
Firm submitted the patent document of innovator brand according to which the solid
dosage form is bilayer tablet, document was extracted from the link
https://ppubs.uspto.gov/pubwebapp/. However, the review report of innovator brand
present on USFDA official website claim that the Roszet tablet is film coated tablet.
Further, previously Registered all brands of Rosuvastatin and Ezetimibe in Pakistan are
film coated tablet.
FDA TGA MHRA
Orange book share Australian Public Assessment Reference of product from
patent of ROSZET Report for Rosuzet, Ezalo “Public Assessment Report
which is US9763885 The Advisory Committee on (NL/H/3647/001/DC)
indicate product is Prescription Medicines Twicor 10 mg/10 mg, film-
bilayer film coated (ACPM), having considered coated tablets
the evaluations and the (rosuvastatin
Delegate’s overview, as well calcium/ezetimibe)
as the sponsor’s response to As mention above,
these documents, advised the reference of Public
following: Assessment report in
The ACPM resolved to section II Quality Aspects
recommend to the TGA Introduction i.e.:
delegate of the Minister and “Twicor is a pink colored
Secretary that: round shaped bilayer film-
The ACPM, taking into coated tablet embossed with
account the submitted “AL” on one side.”
evidence of efficacy, safety Moreover in manufacturing
and quality, agreed with the process it is stated that
Delegate and considered The manufacturing process
Rosuzet/Ezalo bilayer tablets, of the drug product can be
containing ezetimibe and divided in three steps:
rosuvastatin (as calcium) as a manufacture of rosuvastatin
new combination of active granules; manufacture of
ingredients in the doses of 10 ezetimibe granules;
mg/5 mg, 10 mg/10 mg, 10 compression into bi-layer
mg/20 mg and 10 mg/40 mg. tablets and film coating of
tablets. The process is a
All of these stregnths are standard manufacturing
uncoated bilayer tablet process.”
according to the product (Enclose for reference)
description available on the
official website of TGA Reference of product from
Australia. MHRA (Summary Of
Product Characteristics):
NAME OF THE
MEDICINAL PRODUCT:
Twicor 20 mg/10 mg film-
coated tablets
QUALITATIVE AND
QUANTITATIVE
COMPOSITION:
Each film-coated tablet
contains 20 mg of
rosuvastatin (as calcium)
and 10 mg of ezetimibe. For
the full list of excipients, see
section 6.1.In section 6 of
“Summary of Product
Characteristics” it is clearly
evident that product is
bilayer tablet as separate
core formulation for
Rosuvastatin layer and
separate core formulation
for Ezetimibe layer is
mention
Summary of product
characteristic available on
the official website of
MHRA, describe the
product as film coated
tablet and the word
bilayer is not mentioned in
the
document.Further,only
the applied two stregnths
i.e. 10/10 and 20/10 mg of
Rosuvastatin/Ezetimibe is
available in this brand.
3. 3.2.P.5.2 Justify for using same dissolution Firm submitted the revised
medium for both active substances dissolution testing method in
when the release behavior of both accordance with innovator brand
substance has varied across all three Roszet tablet and performed 6th
physiological mediums as evident month stability studies as per revised
from the submitted CDP report, finished product specification.
similarly the innovator brand also
recommended two different
dissolution medium for both active
substances.
4. 3.2.P.8.2 Provide the valid GMP certificate ofFirm submitted the valid Drug
API manufacturer Rosuvastatin manufacturing licence of M/s.
calcium ,since the submitted Ruyuan HEC Pharm Co.
certificate was of year 2019. Ltd.,China,expiry date of license is
07th October,2026.
Decision: Regisration Board deliberated the above cited references from MHRA wherein
composition for core of each drug substance has been mentioned separately making it evident
that the reference product is approved as bi-layer tablet. Hence Regsitration Board approved
the “Roviros Eze 5/10 mg Tablet”.
Telephone: + (21) 32213886, 32633590,
UAN 111-742-762
LTD.
Telephone: + (21) 32213886, 32633590,
UAN 111-742-762
☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand name Roviros Eze Tablets 10mg + 10mg
Pharmaceutical ingredient (API) per unit Rosuvastatin Calcium eq. to Rosuvastatin
USP…………………...…10mg
Ezetimibe USP…………..10mg
Pharmaceutical form of applied drug Light yellow color round shape film coated
tablet, one side engraved NQ and other side
engraved bisect line.
combination with other lipid modifying
agents
The status in reference regulatory authorities Roszet Tablets (Rosuvastatin + Ezetimibe) is
registered and being marketed by Althera
Pharmaceuticals LLC (Approved by US
FDA, United States of America).
For generic drugs (me-too status) Rovista Eze Tablets 10/10mg by M/s Getz
Pharma (Pvt.) Ltd., (Reg. No. 073718)
Each film-coated tablet contains:
Rosuvastatin Calcium eq. to
Rosuvastatin………………………………1
0mg
Ezetimibe………………………………….1
0mg
Shaoguan City, Guangdong Province,
P.R.China.
Ezetimibe:
Sy.No. Parts of 27, 46 & 50 to 56,
Ezetimibe:
substance.
months
201704102, RSV-201705101
6 months
201704102, RSV-201705101
Ezetimibe:
months
Batches: EI0011117, EI0021217,
EI0031217
6 months
Batches: EI0011117, EI0021217,
EI0031217
product.
media (pH 1.2), Acetate Buffer (pH 4.5 & pH
4.5 with 0.45% SLS {QC release media for
Ezetimibe}), Citrate Buffer (pH 6.6) &
Phosphate Buffer (pH 6.8). The values for f1
and f2 are in the acceptable range.
Shaoguan City, Guangdong Province, P.R. China.
Ezetimibe:
Sy.No. Parts of 27, 46 & 50 to 56, Ananthasagar (Vill), Chegunta (Mandal),
RSV-(RD)202104602
Ezetimibe:
EZ0160621
Description of Pack
(Container closure Alu-Alu blister packed in unit carton (1×10’s).
system)
Batch No. 486DS01 486DS02 486DS03
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of Rosuvastatin Calcium:
Ezetimibe:
22/02/2023.
3. Documents for the procurement of API with Rosuvastatin Calcium:
provided.
Ezetimibe:
provided.
chromatograms,
etc.
no. comings
USP specification.
Further, previously Registered all brands of Rosuvastatin and ezetimibe in Pakistan are
film coated tablet.
FDA TGA MHRA
NAME OF THE
MEDICINAL PRODUCT:
coated tablets
QUALITATIVE AND
QUANTITATIVE
COMPOSITION:
contains 20 mg of
mention
Summary of product
MHRA, describe the
tablet and the word
the
i.e. 10/10 and 20/10 mg of
substances.
4. 3.2.P.8.2 Provide the valid GMP certificate of Firm submitted the valid Drug
Ruyuan HEC Pharm Co.
calcium ,since the submitted Ltd.,China,expiry date of license is
certificate was of year 2019. 07th October,2026.
Telephone: + (21) 32213886, 32633590,
UAN 111-742-762
LTD.
Telephone: + (21) 32213886, 32633590,
UAN 111-742-762
☐ Importer
giver)
Status of application ☐New Drug Product (NDP)
☒Generic Drug Product (GDP)
☐ Export sale
The proposed proprietary name / brand name Roviros Eze tablets 20mg/10mg
….20mg
Ezetimibe USP……... 10mg
Pharmaceutical form of applied drug Pink colored, round shaped, film coated
tablet, both sides plain
combination with other liquids modifying
agents.
Proposed Pack size 10’s tablets
The status in reference regulatory authorities Product Roszet tablets (Rosuvastatin +
Ezetimibe) is Registered and being marketed
Althera Pharmaceuticals LLC (Approved by
US FDA, United states of America)
For generic drugs (me-too status) Getz Pharma.
Rovista Eze tablet 20mg/10mg (Reg.
No.073717)
Rosuvastatin Calcium eq. to Rosuvastatin
….20mg
Ezetimibe…. 10mg
(Innovator’ s Specification)
Ruyan HEC PHARMA CO., LTD.
Xiaba development zone, Ruyan Country,
Shaoguan City, Guongdong Province, PR
China
Saptagir Laboratories Pvt. Ltd:

Sy. No. Parts of 27, 46, 50 to 56
Medak District, telagana , India
Ezetimibe:
substance.
months
201704102, RSV-201705101
6 months
201704102, RSV-201705101
Ezetimibe:
months
Batches: EI0011117, EI0021217,
EI0031217
6 months
Batches: EI0011117, EI0021217,
EI0031217
specification, eference standard, container
product.
media (pH 1.2), Acetate Buffer (pH 4.5 &
pH 4.5 with 0.45% SLS {QC release media
for Ezetimibe}) & Phosphate Buffer (pH
acceptable range.
Manufacturer of API Rosuvastatin Calcium
Xiaba development zone, Ruyan Country, Shaoguan City, Guongdong
Province, PR China
Ezetimibe:
Sy. No. Parts of 27, 46, 50 to 56
Ananthasagar (Vill), Chegunta (Mandal), Medak District, telagana , India
Tel: 91-7815934034
RSV-(RD)202104602
Ezetimibe:
EZ0160621
Description of Pack
Alu-Alu blister 10’s tablets packed in unit carton.
(Container closure
system)
Batch No. 487DS01 487DS02 487DS03
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of Rosuvastatin Calcium :
Ezetimibe:
22/02/2023.
3. Documents for the procurement of API with Rosuvastatin Calcium
DRAP, Karachi on 30-06-2021 was provide.
Ezetimibe :
provided.
chromatograms,
etc.
no. comings
USP specification.
film coated tablet.
FDA TGA MHRA
NAME OF THE
MEDICINAL PRODUCT:
coated tablets
QUALITATIVE AND
QUANTITATIVE
COMPOSITION:
contains 20 mg of
mention
Summary of product
MHRA, describe the
tablet and the word
the
i.e. 10/10 and 20/10 mg of
substances.
4. 3.2.P.8.2 Provide the valid GMP certificate ofFirm submitted the valid Drug
calcium ,since the submitted Ruyuan HEC Pharm Co.
certificate was of year 2019. Ltd.,China,expiry date of license is
07th October,2026.
Manufacturer will perform process validation of first three batches as per the commitment
Telephone: + (21) 32213886, 32633590,
UAN 111-742-762
E-mail address: info@nabiqasim.com

LTD.
Telephone: + (21) 32213886, 32633590,
UAN 111-742-762

☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand name Roviros Eze tablets 40mg/10mg
….40mg
Ezetimibe USP……... 10mg
Pharmaceutical form of applied drug Light yellow, round shaped, one side
engraved NQ while other side is plain.
combination with other liquids modifying
agents.
Proposed Pack size 10’s tablets
The status in reference regulatory authorities Product Roszet tablets (Rosuvastatin +
Ezetimibe) is Registered and being marketed
Althera Pharmaceuticals LLC (Approved by
US FDA, United states of America)
Xiaba development zone, Ruyan Country,
Shaoguan City, Guongdong Province, PR
China
Sy. No. Parts of 27, 46, 50 to 56
Medak District, telagana , India
Ezetimibe:
substance.
months
201704102, RSV-201705101
6 months
201704102, RSV-201705101
Ezetimibe:
months
Batches: EI0011117, EI0021217,
EI0031217
6 months
Batches: EI0011117, EI0021217,
EI0031217
product.
dissolution profile established against the brand leader Zympass
tablet 40/10mg is registered and being
marketed by Sanofi Ireland., by performing
quality tests (Description, Identification,
Dissolution and Assay)
brand that is Zympass tablet 40/10mg
10mg) by Sanofi Ireland, in Acid media (pH
1.2), Acetate Buffer (pH 4.5 & pH 4.5 with
0.45% SLS {QC release media for
Ezetimibe}) & Phosphate Buffer (pH 6.8).
range.
Manufacturer of API Rosuvastatin Calcium

Xiaba development zone, Ruyan Country, Shaoguan City, Guongdong
Province, PR China
Ezetimibe:
Sy. No. Parts of 27, 46, 50 to 56
Ananthasagar (Vill), Chegunta (Mandal), Medak District, telagana , India
Tel: 91-7815934034
RSV-(RD)202104602
Ezetimibe:
EZ0160621
Description of Pack
(Container closure Alu-Alu blister 10’s tablets packed in unit carton.
system)
Batch No. 488DS01 488DS02 488DS03
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of Rosuvastatin Calcium :
Ezetimibe:
22/02/2023.
3. Documents for the procurement of API with Rosuvastatin Calcium
Ezetimibe :
provided.
chromatograms,
etc.
no. comings
USP specification.
film coated tablet.
FDA TGA MHRA
NAME OF THE
MEDICINAL PRODUCT:
coated tablets
QUALITATIVE AND
QUANTITATIVE
COMPOSITION:
contains 20 mg of
mention
Summary of product
MHRA, describe the
tablet and the word
the
i.e. 10/10 and 20/10 mg of
substances.
4. 3.2.P.8.2 Provide the valid GMP certificate of Firm submitted the valid Drug
Ruyuan HEC Pharm Co.
calcium ,since the submitted Ltd.,China,expiry date of license is
certificate was of year 2019. 07th October,2026.
259. Name, address of Applicant / Marketing M/s Vision Pharmaceuticals (Pvt.) Ltd.
Islamabad-44000
Islamabad-44000
☐ Importer
giver)
Intended use of pharmaceutical product ☐Domestic sale
☐ Export sale
Ivabradine 5mg tablet
name
Pharmaceutical ingredient (API) per unit Ivabradine as Hydrochloride…………5mg
Pharmaceutical form of applied drug Light Orange colored, round, biconvex
shaped, film coated tablet
Pharmacotherapeutic Group of (API) hyperpolarization-activated cyclic
nucleotide-gated (HCN) channel blockers
Innovator Specs
specifications
The status in reference regulatory Corlanor 5mg tablet by M/s AMGEN INC,
For generic drugs (me-too status) Ivadin 5mg Tablet by M/s PharmEvo Pvt.
Ltd., Reg. No. 090910
manufacturer inspection conducted on 11-02-2019, was
valid till 09-05-2022 after extension for 3
months.
Request for GMP inspection R&1 date: 22-
12-2021 is provided.
Name and address of API manufacturer. M/s Lewens Labs Pvt., Ltd.
Plant: D2/CH/376-377, G.I.D.C, Dahej, Dist.
Bharuch, Gujarat, India-392130
verification, batch analysis and justification
controls, tests for impurities & related
substances (impurity A & unspecified),
substance
Real time: 2°C to 8°C for 60 months
months
Batches: (LIV0014001, LIV0014002,
LIV0014003)
buffer medium) and its verification studies,
product.
comparative dissolution profile established against the brand leader that is
Sivab 5mg tablet by Getz Pharmaceuticals
Pvt. Ltd., by performing quality tests
(Physical Appearance, identification,
Average weight, Disintegration Time,
Assay).
brand that is Sivab 5mg tablet by Getz
Pharmaceuticals Pvt. Ltd., in Acid media (pH
1.0-1.2) & Phosphate Buffer (pH 6.8). The
values for f1 and f2 are in the acceptable
range.
Analytical method validation/verification of Method verification studies have submitted
Manufacturer M/s Lewens Labs Pvt., Ltd.
of API Plant: D2/CH/376-377, G.I.D.C, Dahej, Dist. Bharuch, Gujarat, India-392130
API Lot No. LFP003020009A1
Description of
Pack
(Container Alu-PVC blister packed in unit carton (14’s)
closure
system)
Stability
Real time: 30°C ± 2°C / 65% ± 5%RH
Storage
Condition
Frequency Accelerated: 0, 2, 4, 6, 9, 12, 18, 24 (Months)
Manufacturin 05-2021 05-2021 05-2021
g Date
Date of
12-06-2021 12-06-2021 12-06-2021
Initiation
No. of
03
Batches
1. The firm has referred to previous inspection of
stability data of the same dosage form on the
basis of which Registration Board in 286th
meeting decided to approve registration of
Reference of previous approval of
Sofovir-V 400mg/100mg Tablet.
firm
The firm has provided data loggers with
stability chambers.
2.
Certificate of Analysis of API from both API
Submitted
manufacturer.

API Manufacturer and Finished Product Submitted
manufacturer
4.
Stability study data of API from API Submitted
manufacturer
5. Approval of API/ DML/GMP certificate of Copy of DML, License No. G/25/2241

API manufacturer issued by concerned issued by FDCA valid till 22/10/2022.
regulatory authority
of country of origin.
6. Documents for the procurement of API with The firm has submitted copy of invoice to
approval from DRAP (in case of import). import Ivabradine HCl (0.350 Kg, invoice No:
COM/20-21/PR002) and ADC (I&E) granted
by DRAP dated on 10/02/2021
stability study Submitted
8.
Method used for analysis of FPP Submitted
9. Drug-excipients compatibility studies Not Applicable
(where applicable)
10. Complete batch manufacturing record of Submitted
three stability batches.
11. Record of comparative dissolution data Submitted
(where applicable)
testing.
chambers (real time
and accelerated)
S. Observations/Deficiencies/ Short- Reply of the Firm
no. comings
1. Scientific justification is required for Firm replied that Test for Optical rotation
not performing the optical rotation test performed and included in the COA.
while analysis of drug substance, since
the optical rotation test is the part of
COA of drug substance manufacturer
and also included in the drug substance
specification of innovator brand.
2. Justification is required for using Firm replied that we had mistakenly

different assay method by drug product mentioned the outdated method from DMF in
manufacturer from that specified by the the dossier. Correct assay method has been
drug substance manufacturer. submitted.
3. Specify details including batch number and manufacturing date of the reference /
comparator product against which pharmaceutical equivalence is performed.
CDP performed against Getz pharma product Sivab 5mg and 7.5mg tablets.
Sivab 5mg tablets Batch number 143F83 Mfg 12-2020 and expiry is 12-2022
Sivab 7.5mg tablets Batch number 019F84 Mfg 11-2019 and expiry is 11-2021.
4. Justification is required for not Firm replied that Content uniformity test is
performing content uniformity test performed on separate sheets. Not mentioned
while establishing the pharmaceutical on COA.These will be provided.
equivalence against the reference
product.
5. Review report of innovator brand Firm replied that We had followed the limits
revealed that the recommended of USP general monograph i.e NMT 30
acceptance criteria for disintegration minutes for coated tablets.
test is ≤ 10 minutes, justify the However, during testing this can be seen that
disintegration limit adapted for the our tablets disintegrate in very less time
applied product i.e. NMT 30min in light almost 4 to 5 minutes. So, this can be
of innovator’s limit. reviewed.
6. Specify the time point in the dissolution Firm replied that as per USP general chapter
acceptance limit at which NLT 80% we selected the 30 minutes’ time, while as per
drug should be dissolved. CDP profile the drug release in buffer
medium is greater. Even in 20 minutes 92.8
% drug was released.
However the innovator brand approved in
USFDA revealed that the drug product
dissolves (> % in 15 min) across the
physiologically relevant range of pH.
7. Submit complete stability data of 6 Firm submitted the 6th month stability data of
months performed at accelerated drug product.
stability condition and stability data of
minimum 6 moth or complete data till
the claimed shelf performed at long term
stability conditions.
8. Provide details that which lot number of Firm submitted DRAP attested documents of
drug substance has been used in lot no. LFR003020009A1.
manufacturing of each batch of drug
product. Also provide documents
confirming evidence of import of each
lot of drug substance used in
manufacturing of these batches of drug
product.
Decision: Approved.
• Registration Board further decided that registration letter will be issued after submission
of revised dissolution and disintegration acceptance criteria in line with USFDA innovator
brand and performance of both these test in accordance with revised specification on next
time point of stability.
specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021
260. Name, address of Applicant / Marketing M/s Vision Pharmaceuticals (Pvt.) Ltd.
Islamabad-44000
Islamabad-44000
☐ Importer
giver)
☐ Export sale
Dy. No. and date of submission Dy. No. dated 01-12-2021
Ivabradine 7.5mg Tablet
name
Pharmaceutical ingredient (API) per unit Ivabradine as Hydrochloride…………7.5mg
Pharmaceutical form of applied drug Light Orange colored, round shaped
biconvex, film coated tablet
Pharmacotherapeutic Group of (API) hyperpolarization-activated cyclic
nucleotide-gated (HCN) channel blockers
Innovator Specs
specifications
The status in reference regulatory Corlanor 7.5mg tablet by M/s AMGEN INC,
For generic drugs (me-too status) Ivadin 7.5mg Tablet by M/s PharmEvo Pvt.
Ltd., Reg. No. 090911
manufacturer inspection conducted on 11-02-2019, was
valid till 09-05-2022 after extension for 3
months.
Request for GMP inspection R&1 date: 22-
12-2021 is provided.
Name and address of API manufacturer. M/s Lewens Labs Pvt., Ltd.
Plant: D2/CH/376-377, G.I.D.C, Dahej, Dist.
Bharuch, Gujarat, India-392130
controls, tests for impurities & related
substance
Real time: 2°C to 8°C for 60 months
months
Batches: (LIV0014001, LIV0014002,
LIV0014003)
product.
Sivab 7.5mg tablet by Getz Pharmaceuticals
Pvt. Ltd., by performing quality tests
(Physical Appearance, identification,
Average weight, Disintegration Time,
Assay).
brand that is Sivab 7.5mg tablet by Getz
Pharmaceuticals Pvt. Ltd., in Acid media (pH
range.
Manufacturer of API M/s Lewens Labs Pvt., Ltd.
Plant: D2/CH/376-377, G.I.D.C, Dahej, Dist. Bharuch, Gujarat, India-
392130
API Lot No. LFP003020009A1
Description of Pack
system)
Frequency Accelerated: 0, 2, 4, 6, 9, 12, 18, 24 (Months)
No. of Batches 03
13. The firm has referred to previous inspection
of stability data of the same dosage form on
the basis of which Registration Board in 286th
meeting decided to approve registration of
Reference of previous approval of
Sofovir-V 400mg/100mg Tablet.
the firm
The firm has provided data loggers with
stability chambers.
14.
Certificate of Analysis of API from both
Submitted
manufacturer.

API Manufacturer and Finished Product Submitted
manufacturer
16.
Stability study data of API from API Submitted
manufacturer
17. Approval of API/ DML/GMP certificate of Copy of DML, License No. G/25/2241
API manufacturer issued by concerned issued by FDCA valid till 22/10/2022.
regulatory authority
of country of origin.
18. Documents for the procurement of API with The firm has submitted copy of invoice to
approval from DRAP (in case of import). import Ivabradine HCl (0.350 Kg, invoice No:
COM/20-21/PR002) and ADC (I&E) granted
by DRAP dated on 10/02/2021
stability study Submitted
20.
Method used for analysis of FPP Submitted
21. Drug-excipients compatibility studies Not Applicable
(where applicable)
(where applicable)
testing.
stability chambers (real time
and accelerated)
no. comings
1. Scientific justification is required for Firm replied that Test for Optical rotation
not performing the optical rotation test performed and included in the COA.
while analysis of drug substance, since
the optical rotation test is the part of
COA of drug substance manufacturer
and also included in the drug substance
specification of innovator brand.
2. Justification is required for using Firm replied that we had mistakenly
different assay method by drug product mentioned the outdated method from DMF in
manufacturer from that specified by the the dossier. Correct assay method has been
drug substance manufacturer. submitted.
3. Specify details including batch number and manufacturing date of the reference /
comparator product against which pharmaceutical equivalence is performed.
CDP performed against Getz pharma product Sivab 5mg and 7.5mg tablets.
Sivab 5mg tablets Batch number 143F83 Mfg 12-2020 and expiry is 12-2022
Sivab 7.5mg tablets Batch number 019F84 Mfg 11-2019 and expiry is 11-2021.
4. Justification is required for not Firm replied that Content uniformity test is
performing content uniformity test performed on separate sheets. Not mentioned
while establishing the pharmaceutical on COA.These will be provided.
equivalence against the reference
product.
5. Review report of innovator brand Firm replied that We had followed the limits
revealed that the recommended of USP general monograph i.e NMT 30
acceptance criteria for disintegration minutes for coated tablets.
test is ≤ 10 minutes, justify the However, during testing this can be seen that
disintegration limit adapted for the our tablets disintegrate in very less time
applied product i.e. NMT 30min in light almost 4 to 5 minutes. So, this can be
of innovator’s limit. reviewed.
6. Specify the time point in the dissolution Firm replied that as per USP general chapter
acceptance limit at which NLT 80% we selected the 30 minutes’ time, while as per
drug should be dissolved. CDP profile the drug release in buffer
medium is greater. Even in 20 minutes 92.8
% drug was released.
However the innovator brand approved in
USFDA revealed that the drug product
dissolves (> % in 15 min) across the
physiologically relevant range of pH.
7. Submit complete stability data of 6 Firm submitted the 6th month stability data of
months performed at accelerated drug product.
stability condition and stability data of
minimum 6 moth or complete data till
the claimed shelf performed at long term
stability conditions.
8. Provide details that which lot number of Firm submitted DRAP attested documents of
drug substance has been used in lot no. LFR003020009A1.
manufacturing of each batch of drug
confirming evidence of import of each
lot of drug substance used in
manufacturing of these batches of drug
product.
Decision: Approved.
• Registration Board further decided that registration letter will be issued after submission
of revised dissolution and disintegration acceptance criteria in line with USFDA innovator
brand and performance of both these test in accordance with revised specification on next
time point of stability.
261. Name, address of Applicant / Marketing M/s PDH Laboratories (Pvt) Ltd. 9.5km
Authorization Holder Sheikhupura Road Lahore
Name, address of Manufacturing site. M/s PDH Laboratories (Pvt) Ltd. 9.5km
Sheikhupura Road Lahore
☐ Importer
giver)
☐ Export sale
Pd-Lac Syrup 120ml
name
Strength / concentration of drug of Active 100ml Pd-Lac contains: 66.7g Lactulose USP
Pharmaceutical ingredient (API) per unit
Pharmaceutical form of applied drug Clear viscous liquid , colorless or pale
brownish yellow color Syrup
Pharmacotherapeutic Group of (API) Laxative
Manufacturer Specs
specifications
The status in reference regulatory Duphalac Syrup 66.7g/100ml Abbott
authorities Laboratories.
For generic drugs (me-too status) Duphalac Syrup 66.7g/100ml Abbott
Laboratories (Pakistan) Ltd.
Reg #006655
GMP status of the Finished product New GMP license was granted on
New additional section for oral liquid syrup
(General) was approved on June 7,2022.
Name and address of API manufacturer. Fresenius Kabi Austria Gmbh
EstermannstraBe 17,
A-4020 Linz.
Module III (Drug Substance) Official monograph of Lactulose solution is
present in USP. The firm as submitted detail
of nomenclature, structure, general
process and controls, tests for impurity of
related substances , specifications, analytical
months
Accelerated: 40°C ± 2°C / 75% ± 5% RH for
6 months
Batches: (17144742,17144852,17144861)
Duphalac syrup 66.7mg/100ml by M/s
Abbott Laboratories (Pakistan) Ltd. by
Assay).
Comparative dissolution profile is not
applicable

Manufacturer of API M/s Fresenius Kabi Austria Gmbh EstermannstraBe 17,
A-4020 Linz.

Description of Pack Clear viscous liquid , colorless or pale brownish yellow color Syrup
(Container closure system) filled in a ambered glass bottle sealed with aluminium cap packed in
a unit carton along with leaflet.
Batch No. T-001 T-002 T-003
Batch Size 40 bottles 40 bottles 40 bottles
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. INS.480019-
API manufacturer issued by concerned 0065-001.
3. Documents for the procurement of API with • Copy of letter No.5201/2020/DRAP-AD-

approval from DRAP (in case of import). CD(I&E) dated 16/04/2020 is submitted
wherein the permission to import different
APIs including Lactulose Solution for the
purpose of test/analysis and stability
studies is granted.
4. Data of stability batches will be supported by
chromatograms, Submitted
etc.
21CFR & audit trail reports on product Submitted
testing
Submitted
accelerated)
S.no Observations/Deficiencies/ Short-comings
.
1. Justify the finished product specifications as “Manufacturer’s specifications” since
the drug product monograph is available in USP. Revise your specifications along
with submission of requisite fee.
Firm replied that they claimed innovator’s specification as per the duphalac syrup brand
of M/s. Abbott Lab., Karachi.
2. Clarification is required either you have import lactulose concentration or
lactulose solution from the Fresenius Kabi, Austria, since the COA of drug
substance reflect that that lactulose solution is the drug substance while the
stability data and manufacturing data of drug substance reveal that the imported
drug substance is lactulose concentrate.
Firm submitted the reply that they have imported Lactulose solution from M/s.
Fresenius kabi, Austria and submit COA of drug substance (Lactulose solution as a
reference.
3. Submit data in section 3.2.S.4.1 and 3.2.S.4.2 as per the guidance document
approved by Registration Board which specifies that “Copies of the Drug
substance specifications and analytical procedures used for routine testing of the
Drug substance /Active Pharmaceutical Ingredient by both Drug substance &
Drug Product manufacturer is required”, since you have only submitted analytical
procedure by drug substance manufacturer which is also not in accordance with
USP.
Undertaking submitted, they will submit later.
4. Submit data in section 3.2.S.4.3 as per the guidance document approved by
Registration Board which specifies that “Analytical Method Verification studies
including specificity, accuracy and repeatability (method precision) performed by
the Drug Product manufacturer for both compendial as well as non-compendial
drug substance(s) shall be submitted” Further specify how the testing of drug
substance was carried out without performing verification studies.
Undertaking submitted, they will submit later.
5. Submit detailed analytical procedure used for testing of drug product in
accordance with USP monograph of lactose solution.
Firm submit the analytical procedure which is not in accordance with USP in terms of
assay procedure.
6. Justify for performing the verification of assay procedure using UV method since
in USP monograph of lactose solution assay has been performed on HPLC.
Not submitted.
7. For quantitative tests, actual numerical results should be provided rather than vague
statements such as “within limits” or “conforms”, since the submitted batch analysis
report of drug product only mentioned the statement complies and positive in
result column.
Revised Batch analysis report submitted by the firm.
8. • Provide Record of Digital data logger for temperature and humidity monitoring of
stability chambers (real time and accelerated). Submitted
• Submit the valid GMP certificate of API manufacturer issued by concerned
regulatory authority of country of origin. Submitted
9. Provide copy of Batch Manufacturing Record (BMR) for all the batches of drug
product for which stability studies data is provided in Module 3 section 3.2. P.8.3.
Submitted
• Revise specification in line with USP monograph of Lactose Solution along with requisite
fee.
• Submit data in section 3.2.S.4.1 and 3.2.S.4.2 as per the guidance document approved by
Registration Board which specifies that “Copies of the Drug substance specifications and
analytical procedures used for routine testing of the Drug substance /Active
Pharmaceutical Ingredient by both Drug substance & Drug Product manufacturer is
required”, since you have only submitted analytical procedure by drug substance
manufacturer which is also not in accordance with USP.
• Submit data in section 3.2.S.4.3 as per the guidance document approved by Registration
Board which specifies that “Analytical Method Verification studies including specificity,
accuracy and repeatability (method precision) performed by the Drug Product
manufacturer for both compendial as well as non-compendial drug substance(s) shall be
submitted” Further specify how the testing of drug substance was carried out without
performing verification studies.
• Submit detailed analytical procedure used for testing of drug product in accordance with
USP monograph of lactose solution along with the analytical method verification report.
262. Name, address of Applicant / Marketing M/s Surge Laboratories Private Limited
Authorization Holder 10th KM, Faisalabad Road, Bikhi District
Sheikhupura, Pakistan.
Name, address of Manufacturing site. M/s Surge Laboratories Private Limited
10th KM, Faisalabad Road, Bikhi District
Sheikhupura, Pakistan.
☐ Importer
giver)
☐ Export sale
Hemarest 250mg/5ml Injection
name
Pharmaceutical ingredient (API) per unit Tranexamic Acid BP … 250mg
(BP Specifications)
Pharmaceutical form of applied drug Clear, Colorless liquid free from foreign
particles.
Pharmacotherapeutic Group of (API) Antihaemorrhagics, Antifibrinolytics.
BP Specifications
specifications
Proposed Pack size 5ml x 5’s
5ml x 10’s
The status in reference regulatory Azeptil Injection 250mg/5mlt by M/s
authorities Medochemie Ltd., MHRA Approved.
For generic drugs (me-too status) Tranmax Injection by M/s Nabiqasim
Industries (Pvt). Ltd., Reg. No. 057745
manufacturer General Liquid Injectables (Including blow
fill seal area) & Cephalosporin Dry Powder
Injectables section approved.
Name and address of API manufacturer. Changzhou Yinsheng Pharmaceuticals Co.
(Pvt). Ltd.
Weitang, Chemical zone, Xinbei District,
Changzhou, Jiangsu Province - 213033
China.
Module III (Drug Substance) Official monograph of Tranexamic Acid is
present in BP. The firm as submitted detail of
controls, tests for impurity D, G & related
substance
months.
12 months.
Batches: (100301, 100303, 100302)
product.
Transamin Injection 250mg/5ml by Hilton
Pharma by performing quality tests
(Description, pH, Assay, Bacterial
Endotoxins and Sterility).
precision, specificity, Limit of Detection,
Limit of Quantitation, Ruggedness &
Robustness.
Manufacturer of API Changzhou Yinsheng Pharmaceuticals Co. (Pvt). Ltd.
Weitang, Chemical zone, Xinbei District, Changzhou, Jiangsu
Province - 213033 China
Description of Pack 5ml Break Ring Clear Glass Ampoule (USP Type I) as
(Container closure system) 5ml x 5’s
5ml x 10’s
Batch No. TRI-001V TRI-002W TRI-003W
Batch Size 1500 Ampoules 1500 Ampoules 1500 Ampoules
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. JS20170680
API manufacturer issued by concerned issued by China Food And Drug
regulatory authority of country of origin. Administration valid till 20/06/2022.
3. Documents for the procurement of API with Copy of Invoice No. 2014DW145-DRAP
approval from DRAP (in case of import). dated 08.01.2015 is submitted for Tranexamic
Acid.

chromatograms,
etc.
testing
accelerated)
S.no. Sections Observations/Deficiencies/ Short-comings
1. 3.2. S.4.3 Validation of analytical procedures
Provide analytical Method Verification studies including specificity,
accuracy and repeatability performed by the Drug Product manufacturer.
2. 3.2. P.2 • Justification is required regarding the use of NaOH and HCl for pH
adjustment as the innovator/reference product has not been used any
excipient for pH adjustment.
• Justify the performance of pharmaceutical equivalence with Transmin
injection instead of using innovator / reference product.
•Justify the process of terminal sterilization via autoclave at 121°C for
15minutes with reference to degradation occurred in the accelerated
stability studies conducted at 40°C as claimed in pharmaceutical
development section. If the degradation of product start at 40°C then
how the product will bear the temperature of 121°C during terminal
sterilization.
• Justify the degradation of your product during accelerated stability
studies because as per the innovator /reference product, the drug
product remains stable during the accelerated stability studies
conducted at 40 ° C, relative humidity 75%, 6 months and no overage
has been used in their formulation.
3. 3.2. P.5.1 Validation of analytical procedures:
You have submitted the validation studies of assay method of transic
injection by spectrophotometer while according to the BP monograph of
tranexamic acid injection assay has been performed via potentiometric
titration, clarification is required in this regard.
4. 3.2. P.8 Stability
• As per the submitted stability data, stability studies of all three
batches has been initiated in the year 2015 and 2016 despite that firm
has submitted only 6 months data of real time stability study for all
three batches. Submit the remaining real time stability data of all
three batches.
• Submitted raw data sheets reflect that the assay of drug product has
been performed via UV spectrophotometer while according to BP,
assay of the drug product has been performed by potentiometric
titration. Justify, how your product complies BP specification.
• Submit compliance Record of HPLC software 21CFR & audit trail
5. 2.3. R.1.1 Provide copy of Batch Manufacturing Record (BMR) for all the batches
section 3.2. P.8.3.
6. Amendment in QOS (Module 2) for above points.
263. Name, address of Applicant / Marketing M/s SAMI Pharmaceuticals (Pvt.) Ltd. F-95,
Authorization Holder Off Hub River Road, S.I.T.E. Karachi.
Name, address of Manufacturing site. M/s SAMI Pharmaceuticals (Pvt.) Ltd. F-95,
Off Hub River Road, S.I.T.E. Karachi.
☐ Importer
giver)
☐ Export sale
AMPISOL 5mg/2ml Injection
name
Pharmaceutical ingredient (API) per unit Ampisulpride …….5mg
Innovator’s specs
Pharmaceutical form of applied drug IV Injection
Pharmacotherapeutic Group of (API) dopamine-2 (D2) antagonist
Innovator Specs
specifications
The status in reference regulatory BARHEMSYS (Amisulpride) Injection
authorities 5mg/2ml M/s ACACIA PHARMA Inc, 8440
Allison Pointe Blvd, Suite 100, Indianapolis,
IN 46250 USA, USFDA Approved.
For generic drugs (me-too status) NA
GMP status of the Finished product GMP certificate issued dated: 03-08-2022
manufacturer Liquid Injectable (LVP/SVP) (General &
General Antibiotic) section approved.
Name and address of API manufacturer. M/s Sun Pharmaceutical Industries Limited,
Sathammai Village, Karunkuzhi
PostMadhuranthagam Taluk, Kancheepuram
District Tamilnadu – 603 303, India.
impurity & related substances, specifications,
months, 9 months & 12 months respectively
Batches: (PDAMSFL021, CCAMRNF002,
AMRNF20052)
months
Batches: (PDNAMSFL017,
PDNAMSFL019, PDNAMSFL018)
Pharmaceutical equivalence Pharmaceutical Equivalence have been
established against the brand leader that is
BARHEMSYS (Amisulpride) Injection
5mg/2ml M/s ACACIA PHARMA Inc, by
performing quality tests (Appearance,
Identification, Clarity, pH, Wt./ml,
Osmolarity, Particulate matter, Assay,
Organic impurities, Bacterial Endotoxin Test,
Packaging material)
of product including linearity, accuracy, precision
including repeatability & intermediate
precision, robustness, specificty.
Manufacturer of API M/s Sun Pharmaceutical Industries Limited, Sathammai Village,
Karunkuzhi PostMadhuranthagam Taluk, Kancheepuram District
Tamilnadu – 603 303, India.
API Lot No. AMRNF20062
Description of Pack
Glass Vial USP Type-1 (Low Borosilicate)
Batch Size 1700ml 1700ml 1700ml
No. of Batches 03
1. Reference of previous approval of Reference of our last onsite panel inspection
applications with stability study data of the for instant dosage form conducted during last
firm (if any) two years i.e. IBRUO (Ibuprofen) 800mg/100
ml injection which was presented in 289th
meeting of the registration board & hence
approved & registered by registration board
Date of inspection: 28th January 2019
The inspection report confirms following
points
The HPLC software is 21CFR Compliant
stability chamber. Chambers are controlled a
monitored through software having alarm system
alerts as well.
• Related manufacturing area, equipment, personn
and utilities are GMP compliant.
2. Approval of API/ DML/GMP certificate of GMP certificate of M/s. Sun Pharmaceutical
API manufacturer issued by concerned Industries Ltd., is valid until 31st December
regulatory authority of country of origin. 2021and they have applied for further
revalidation period from 01.01.2022to
31.12.2024 and their application is under
process in this Directorate ( letter attached )
3. Documents for the procurement of API with The firm has submitted copy of Aramex
approval from DRAP (in case of import). Courier slip and declaration from API
supplier regarding sending of Amisulpride
(Quantity of 100gms) through Aramex
Courier receipt No. 9155441378 dated 18-04-
2021
4. Data of stability batches will be supported Raw data sheets alongwith chromatograph of
by attested respective documents like Amisulpride COA & Summary data sheet are
chromatograms, attached
sheets etc.
5. Compliance Record of HPLC software Compliance record of HPLC software 21CFR
21CFR & audit trail reports on product & Audit trail testing reports are attached
testing
6. Record of Digital data logger for Digital data logger for temperature and
temperature and humidity monitoring of humidity monitoring of stability chambers are
stability chambers (real time and attached
accelerated)
no. comings
1. Justification is required for not using Firm in their reply stated that The API
sterile drug substance for (Amisulpride) used for development of our
manufacturing of injection, as evident product Ampisol (Amisulpride) 5mg/2ml
from the COA of drug substance by Injection is of injectable grade. API
drug substance manufacturer. manufacturer has performed test for Bacterial
Endotoxin test, Aerobic bacterial test, E. Coli,
Salmonella, Pseudomonas & Staphylococcus
aureus test to ensure the quality of injectable
grade material. Certificate of Analysis of API
manufacturer is enclosed for reference.
Moreover it is not essential for the drug
substance to be sterile for those drug products
which are terminally sterilized/aseptically
filled in their manufacturing process.
2. As per the review literature of Firm replied that Precautionary measure for
innovator brand, the drug product is photo degradation during manufacturing
subject to photo degradation within 12 process from Bulk manufacturing to secondary
hours, so there are no such packaging have been taken and also mentioned
precautionary measures included in in batch Manufacturing record (BMR) which is
the manufacturing procedure to enclosed for reference (Annex-C, Page no.7,
protect the filled vials from light 12, 17)
neither the step of packaging of filled It is also included in CTD dossier 3.2.P.2.3
vial in unit carton preferably within 12 Manufacturing process development and in
hours after optical checking is 3.2.P.3.4. Controls of Critical steps and
included in the final stage. intermediates as a critical parameter,
Clarification is required in this regard. Reference enclosed in (Annex-D, Page no.4 &
9)
As far duration from optical checking to
secondary packaging is concerned, your
suggestion is highly valuable for us and we will
include this control for commercial production
i.e. secondary packaging will be done within 12
hours after optical checking
3. Submit valid GMP certificate of drug Firm submitted the copy of GMP certificate of
substance manufacturer, since the API manufacturer.
submitted certificate was valid until
31-12-2021.
4. Submit documents for the Firm submit the consignment receipt of API
procurement of API including copy of only.
commercial invoice attested by AD
(I&E) DRAP
Decision: Deferred for justification of using non-injectable grade drug substance for
preparation of parenteral solutions, along with submission of supporting reference from the
ICH guidelines or other international stringent regulatory guidance documents.
Cases of Export Facilitation priority:
264. Name, address of Applicant / Marketing M/s ATCO LABORATORIES LTD,

Authorization Holder B-18, S.I.T.E, KARACHI.
Name, address of Manufacturing site. M/s ATCO LABORATORIES LTD, B-18,
S.I.T.E, KARACHI.
☐ Importer
giver)
☐ Export sale
Details of fee submitted PKR 30,000/- dated 19/11/2021
PKR 45,000/- dated 17/10/2022
APREMILAST TABLET 10MG.
name
Pharmaceutical ingredient (API) per unit Apremilast MS 10mg
Pharmaceutical form of applied drug Brick red colored, round, biconvex, film
coated tablets having both sides plain.
Pharmacotherapeutic Group of (API) Apremilast belongs to a class of drugs known
as phosphodiesterase 4 (PDE4) inhibitors.
As per Innovator’s Specifications.
specifications
Proposed Pack size Apremilast 10mg is available in
Starter pack of 14’s & 28’s
Starter pack of 14days Contains
Pack of 4’s 10mg (Pouch 1)
Pack of 5’s &14’s of 30mg (Pouch 3)
And Starter pack of of 28days contains
Pack of 5’s & 3x 14’s of 30mg (Pouch 3)
The status in reference regulatory Otezla 10mg
authorities Amgen Ltd 216 Cambridge Science Park,
Milton Road, Cambridge, CB4 0WA, UK
GMP status of the Finished product Renewal for DML dated 27-03-2021submitted
manufacturer along with previous copy DML.
Name and address of API manufacturer. M/s Enantiotech Corporation Limited
6, Zhongjing Rd, Zhongshan Torch Hi-Tech
Industrial Development Zone, Guangdong
Province, China.
Module III (Drug Substance) In-House specifications of Apremilast is
provided. The firm as submitted detail of
substance.
Real time: 30°C±2°C,65%±5%RH for 36
months
months
Batches: (AMTO3K150303,
AMTO3K150401, AMTO3K151102)
dissolution testing at acidic and buffer
Otezla 10mg Tablet by Amgen Ltd 216
Cambridge Science Park, Milton Road,
Cambridge, CB4 0WA, UK performing
brand that is Otezla 10mg Tablet by Amgen
Ltd 216 Cambridge Science Park, Milton
Road, Cambridge, CB4 0WA, UK in Acid
media (pH 1.0-1.2) & Phosphate Buffer (pH
acceptable range.
specificity.
Manufacturer of Enantiotech Corporation Limited
API No. 6, Zhongjing Rd, Zhongshan Torch Hi-Tech Industrial Development Zone,
Guangdong Province, China.
API Lot No. AMT03R200603
Description of ALU-PVC blister
Pack Aluminium foil pouch
(Container Printed carton
closure system)
With three-month stability 13/01/2022
With six month stability 03/02/2022
Batch No. MY195C MY196C MY197C
Batch Size 2930 tablets 2930 tablets 2930Tablet
s
Manufacturing 05 – 2021 05 – 2021 05 – 2021
Date
Date of Initiation 21-06-
21-06-2021 21-06-2021
2021
No. of Batches 03
1. Reference of previous approval of Rofl 500mg tablet Approved in DRB 277 held
applications with stability study data of the on 27-29 December 2017.
firm (if any)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate of Enantiotech
API manufacturer issued by concerned Corporation Limited issued by People’s
regulatory authority of country of origin. Republic of Chins valid till 01/04/2021 till
30/04/2024.
3. Documents for the procurement of API with Submitted
chromatograms,
etc.
testing
accelerated)
S.no. Observations/Deficiencies/ Short- Reply of the Firm
comings
1. Provide analytical Method verification Submitted
studies including specificity, accuracy
and repeatability performed by the Drug
Product manufacturer.
2. Justification is required for not Revised stability studies including assay
performing the assay test during result are submitted by the firm.
3. Justify for setting the acceptance criteria of dissolution test other than adapted by
innovator/reference product. The review report of innovator brand approved in USFDA
revealed that the recommended dissolution criteria should be NLT (Q) in 30 minutes,
while the dissolution criteria adapted for applied product was much wider i.e.NLT 80%
(Q) in 60 minutes.
Firm submitted the reply that the recommended dissolution criteria as should be NLT
(Q) in 30minutes in USFDA report is published in September 2013 with dissolution
media having 0.3%SLS with 75RPM. In both above references we used the latest
dissolution recommendation published in FDA Database Dated: 05/18/2017 and
established the same on our applied product strengths in which the dissolution criteria
are NLT 80% (Q) in 60 minutes. (Section 3.2.P.5.1)
Table 2: Comparison of US FDA Dissolution Parameters
Parameter Updated 2013 Updated 2017 Changes
USP Apparatus II (Paddle) II (Paddle) Same
Speed 75 RPM 60 RPM Reduced
Medium 0.3% SLS in 25mM 0.15% SLS in 25mM Reduced quantity of
Sodium Phosphate Sodium Phosphate SLS
Buffer, pH 6.8 Buffer, pH 6.8
Volume 900 mL 900 mL Same

In both above references we used the latest dissolution recommendation published in
FDA Database Dated: 05/18/2017 and established the same on our applied product
strengths in which the dissolution results achieved 85% on 60 minutes time point with
less than 10% RSD, that’s why we have taken T=60 Minutes and Q = 75% as per the
procedure defined in SETTING DISSOLUTION RELEASE SPECIFICATIONS in
293rd Meeting minutes.
However, in the FDA dissolution database the recommended sampling time is till
45minutes and one-time point before has been adapted for the acceptance criteria of
dissolution 30 minutes in this instant case.
Later, firm submitted the revised dissolution parameters in line with innovator brand
approved in USFDA.
4. How will the analyst determined the Firm submitted the reply that “The revised
quantity of crushed powder equivalent testing procedure with concentration in
to 30mg of Apremilast in the sample mg/mL of final dilutions of samples is being
preparation of assay testing of 10mg submitted to you for reference while the
and 20mg strength, further specify the quantity of crushed powder as the portion of
concentration of final dilution of tablets considering the average weight of
sample, as it is not mentioned in the tablets is mentioned in all the strengths
assay procedure of all three strength accordingly”.
5. Submit the revised pack size and Firm replied that as advised in 321st meeting
display presentation of packaging of DRB, we are hereby submitting the
container in accordance with the revised pack size and display presentation of
decision of registration of Apremilast packaging container for
tablet 321st meeting of Registration 1. 14 days Starter Pack
Board . 2. 28 days Starter Pack
3. Maintenance Pack of 56 Tablets for
Apremilast 30mg.
6. • Provide stability data of at least six submitted

months or till the claimed shelf life
performed both at accelerated and
long term stability condition.
• Submit COA of relevant batch of
drug substance used in product
from both drug substance as well as
drug product manufacturer in section
3.2.S.4.4.
S.I.T.E, KARACHI.
☐ Importer
giver)
☐ Export sale
PKR 45,000/- dated 17/10/2022
APREMILAST TABLET 20MG.
name
Pharmaceutical form of applied drug Buff colored, round, biconvex, film-coated
tablets.
specifications
Otezla 20mg
authorities
Amgen Ltd 216 Cambridge Science Park,
Province, China.
substance.
months
months
AMTO3K150401, AMTO3K151102)
acceptable range.
specificity.
API Lot No. AMT03-A06-200401
Description of
ALU-PVC blister
Pack
Aluminium foil pouch
(Container
Printed carton
closure system)
With three-month stability 13/01/2022
With six month stability 03/02/2022
Batch Size 4895 tablets 4895 tablets 4895
tablets
Manufacturing 05 – 2021 05 – 2021 05 – 2021
Date
21-06-2021 21-06-2021
2021
No. of Batches 03
firm (if any)
30/04/2024.
chromatograms,
etc.
testing
accelerated)
no. comings
1. Provide analytical Method verification Submitted
and repeatability performed by the Drug
2. Justification is required for not Revised stability studies including assay
performing the assay test during result are submitted by the firm.
(Q) in 60 minutes.

293rd Meeting minutes. (Section 3.2.P.5.1)
However, in the FDA dissolution database the recommended sampling time is till
45minutes and one time point before has been adapted for the acceptance criteria of
approved in USFDA.
4. How will the analyst determined the Firm submitted the reply that “The revised
quantity of crushed powder equivalent testing procedure with concentration in
to 30mg of Apremilast in the sample mg/mL of final dilutions of samples is being
preparation of assay testing of 10mg submitted to you for reference while the
and 20mg strength, further specify the quantity of crushed powder as the portion of
concentration of final dilution of tablets considering the average weight of
sample, as it is not mentioned in the tablets is mentioned in all the strengths
assay procedure of all three strength accordingly”.
5. Submit the revised pack size and Firm replied that as advised in 321st meeting
display presentation of packaging of DRB, we are hereby submitting the
container in accordance with the revised pack size and display presentation of
decision of registration of Apremilast packaging container for
tablet 321st meeting of Registration 4. 14 days Starter Pack
Board . 5. 28 days Starter Pack
6. Maintenance Pack of 56 Tablets for
Apremilast 30mg.
6. • Provide stability data of at least six submitted

months or till the claimed shelf life
performed both at accelerated and
long term stability condition.
• Submit COA of relevant batch of
drug substance used in product
from both drug substance as well as
drug product manufacturer in section
3.2.S.4.4.
S.I.T.E, KARACHI.
☐ Importer
giver)
☐ Export sale
Dy. No. and date of submission Dy. No.1202 dated 13-01-2022
PKR 45,000/- dated 17/10/2022
The proposed proprietary name / brand APREMILAST TABLET 30MG.
name
Pharmaceutical form of applied drug Blue colored, round, biconvex, film-coated
tablets
specifications
Maintenance Pack of 56’s
The status in reference regulatory Otezla 30mg
authorities Amgen Ltd 216 Cambridge Science Park,
For generic drugs (me-too status) Apremist 30mg
Crystolite Pharma, Islamabad
Province, China.
substance.
months
months
AMTO3K150401, AMTO3K151102)
acceptable range.
specificity.
API Lot No. AMT03R200603
Description of
ALU-PVC blister
Pack
Aluminium foil pouch
(Container
Printed carton
closure system)
Batch Size 7000 tablets 7000 tablets 7000
tablets
Manufacturing 05 – 2021 05 – 2021 05 – 2021
Date
21-06-2021 21-06-2021
2021
No. of Batches 03
firm (if any)
30/04/2024.
chromatograms,
etc.
testing
accelerated)
S.no Observations/Deficiencies/ Short- Reply of the Firm
. comings
1. Provide analytical Method Submitted
verification studies including
specificity, accuracy and
repeatability performed by the
Drug Product manufacturer.
2. Justification is required for not Submitted
performing the assay test during
(Q) in 60 minutes.

293rd Meeting minutes. (Section 3.2.P.5.1)
However in the FDA dissolution database the recommended sampling time is till
45minutes and one time point before has been adapted for the acceptance criteria of
approved in USFDA.
4. How will the analyst determined Firm submitted the reply that “The revised testing
the quantity of crushed powder procedure with concentration in mg/mL of final
equivalent to 30mg of Apremilast dilutions of samples is being submitted to you for
in the sample preparation of assay reference while the quantity of crushed powder as
testing of 10mg and 20mg the portion of tablets considering the average
strength, further specify the weight of tablets is mentioned in all the strengths
concentration of final dilution of accordingly”.
sample, as it is not mentioned in
the assay procedure of all three
strength
5. Submit the revised pack size and Firm replied that as advised in 321st meeting of
display presentation of packaging DRB, we are hereby submitting the revised pack
container in accordance with the size and display presentation of packaging
decision of registration of container for
Apremilast tablet 321st meeting of 1. 14 days Starter Pack
Registration Board . 2. Maintenance Pack of 56 Tablets for
Apremilast 30mg.
6. • Provide stability data of at least submitted

six months or till the claimed
shelf life performed both at
accelerated and long term
stability condition.
• Submit COA of relevant batch
of drug substance used in
product development and
stability studies from both drug
substance as well as drug
product manufacturer in section
3.2.S.4.4.
Decision: Registration Board approved the aplications of Apremilast 10mg tablet. Apremilast
20mg tablet & Apremilast 30mg tablet with Innovator’s specifications. Furthermore, in order
to standardize the drug as per dosage regimen of the innovator’s drug product as approved
by reference regulatory authorities, the Board decided that the manufacturers shall adopt
any of the presentation as decided by Registration Board in its 321st meeting for the
“Apremilast “tablets” and registration letter will be issued accordingly.
• Registration letter will be issued after submission of performance of dissolution testing in
line with revised specification on next time point of stability.
267. Name, address of Applicant / Marketing M/s Wimits Pharmaceuticals (Pvt) Ltd.
Authorization Holder Lahore. Plot #129 Sundar Industrial
Estate,Raiwind road,Lahore
Name, address of Manufacturing site. M/s Wimits Pharmaceuticals (Pvt) Ltd. Plot
#129 Sundar Industrial Estate,Raiwind
road,Lahore
☐ Importer
giver)
☐ Export sale
Zapnal 5mg tablet
name
Pharmaceutical ingredient (API) per unit Olanzapine …….5mg
Pharmaceutical form of applied drug Amost white coloured, film coated round plain
tablets
Pharmacotherapeutic Group of (API) Atypical antipsychotic
specifications
The status in reference regulatory Zyprexa 5mg tablet by M/s Eli lilly and
authorities company limited, USFDA Approved.
For generic drugs (me-too status) Olepra 5mg tablet by M/s Genetics
Pharmaceuticlas Pvt. Ltd, Reg. No. 038671
manufacturer Tablet (General) section approved.
Name and address of API manufacturer. M/s RAMPEX LABS PRIVATE LIMITED
Plot No. 34-C Jawaharlal Nehru Pharma City
PARAWADA.VISAKHAPATNAM – 531
019, ANDHRA PRADESH, INDIA.
Module III (Drug Substance) Official monograph of olanzapine is present in
USP. The firm as submitted detail of
controls, tests for impurity Malononitrile, 2-
fluoro Nitrobenzone, Propanaldehyde, N-
methyl piperazine, impurity A,B,C, Methanol,
acetone, IPA, toluene, dimethyl Formamide,
1,4 dioxane & specifications, analytical
months
months
Batches:(LAN-4P/00613, LAN-4P/00713,
LAN-4P/00813)
Zapnal 5mg tablet by Wimits Pharma by
brand that is olepra 5mg tablet by Genetics
Pharmaceuticlas Pvt. Ltd in Acid media (pH-
1.2), Acetate Buffer (pH-4.5) & Phosphate
Buffer (pH 6.8). The values for f1 and f2 are in
the acceptable range.
specificity.
Manufacturer of API M/s RAMPEX LABS PRIVATE LIMITED
Plot No. 34-C Jawaharlal Nehru Pharma City
PARAWADA.VISAKHAPATNAM – 531 019, ANDHRA
PRADESH, INDIA.
API Lot No. LAN/0040420
Description of Pack
system)
Batch No. TZP001 TZP002 TZP003
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No.
API manufacturer issued by concerned 21/VP/AP/2011/B/CC/R issued by FDCA
regulatory authority of country of origin. valid till 29/09/2024.
3. Documents for the procurement of API with Copy of letter No.8623/2020/DRAP-AD-
wherein the permission to import different
APIs including olanzapine for the purpose of
ZHI-CI/4506/0520, DATE: 14-05-2020
4. Data of stability batches will be supported
etc.
testing
Submitted
accelerated)
comings
1. Provide raw data sheets and Firm submitted the analytical procedure
chromatograms of analytical method along verification report in accordance
verification report as the submitted with USP monograph.
report did not specify the assay
procedures.
2. Comparative dissolution profile report Firm submitted the revised CDP report in
of drug product revealed that at 30 which more than 80% drug release within
minutes not more than 80% drug release 30 minutes without
in all three physiological medium, justification/clarification.
justify the results with the acceptance
limit of dissolution i.e. NLT 80% in
30min using pH 1.2 as the
recommended dissolution medium as
per USP monograph.
3. Adapt the acceptance limit of Revised specification submitted by the
dissolution in term of Q, since the USP firm.
monograph specify the limit with Q
value i.e. NLT 80% (Q) of the labelled
amount of olanzapine dissolved.
4. Provide details that which lot number of API lot no. LAN/0040420 has been used
drug substance has been used in in manufacturing of each batch of drug
manufacturing of each batch of drug product.
confirming evidence of import of each GMP certificate of API manufacturer M/s.
lot of drug substance used in RAMPEX Labs Pvt. Ltd., India has been
manufacturing of these batches of drug submitted by the firm which was vaild till
product. 20-04-2021,however the manufacturing
• Submit valid Good Manufacturing license of manufacturer is valid till 29-09-
Practice (GMP) certificate of the 2024 as written on the said GMP
Drug Substance manufacturer issued certificate.
by relevant regulatory authority of
country of origin.
Decision: Approved.
268. Name, address of Applicant / Marketing M/s Horizon Healthcare (Pvt.) Ltd.
Authorization Holder Plot no. 33 Sundar Industrial Estate Lahore.
☐ Importer
giver)
☐ Export sale
Bempp-Z Tablet 180/10mg
name
Strength / concentration of drug of Active Each Film Coated Tablet contains:
Pharmaceutical ingredient (API) per unit Bempedoic Acid…….180mg
Ezetimibe……………...10mg
Pharmaceutical form of applied drug Light blue color, oblong shaped, film coated
tablets
Pharmacotherapeutic Group of (API) Bempedoic Acid: Lipid modifying agents,
other lipid modifying agents. Adenosine
triphosphate citrate lyase (ACL) inhibitor
Ezetimibe: adenosine triphosphate-citrate
lyase (ACL)
inhibitor, Cholesterol absorption inhibitor.
As per innovator
specifications
The status in reference regulatory Nexlizet Tablets 180/10mg approved by US-
authorities FDA
GMP status of the Finished product Last inspection report dated 18.06.2020
manufacturer concluded good level of cGMP compliance.
Name and address of API manufacturer. Bempedoic Acid:
Metrochem API Private Limited, Unit-IV,
Plot No. 34B, 40B & 60B,
J.N. Pharma City, Thanam Village,
Parawada Mandal, Visakhapatnam District,
Andhra Pradesh, 531021,
India (IND).
Ezetimibe:
Zhejiang Tianyu Pharmaceutical Co., Ltd.
No.15, Donghai 5th Avenue, Zhejiang
Provincial Chemical and Medical Raw
Materials Base Linhai Zone, Taizhou City.
to structure, general properties,
Manufacturers, description of manufacturing
process and controls, Characterization,
Impurities, Specifications, Analytical
procedures, Validation of analytical
Module III (Drug Substance) The firm as submitted detail of General
information, General properties,
Manufacturers, description of manufacturing
process and process controls, Characterization,
Impurities, Control of drug substance,
Reference standard or materials container
substance.
Bempedoic Acid:
months
Accelerated: 40°C ± 2°C/75% ± 5%RH for 6
months
Term
BMPD- 6 Months 60 Months
V/A070/44
V/A070/45
V/A070/46
Ezetimibe:
months
months
Term
10910-171101 6 Months 36 Months
10910-171102 6 Months 36 Months
10910-171103 6 Months 36 Months
Microbiological attribution, Manufacturer,
Master formulations, Description of
Manufacturing Process and Process Controls,
Control of Critical Steps and Intermediates,
Process Validation and/ or Evaluation, Control
of Excipients with specification and Analytical
methods, Control of Drug Products including
Finished product specifications and test
methods, validation of Analytical methods,
Batch analysis , Characterization of impurities,
reference standard or impurities, Container
closure and stabilities studies.
Nexlizet Tablets 180/10mg approved by US-
FDA by performing quality tests
(Identification, Assay, and Dissolution. CDP
has been performed against the same brand
that is Nexlizet Tablets 180/10mg approved
by US-FDA approved by US-FDA in Acid
media (pH 1.2) , Acetate Buffer (pH 4.5) &
Phosphate Buffer (pH 6.8)
of product including Introduction, Verification of assay
method, Specificity, Accuracy, Precision,
Linearity concentration and peak range.
Manufacturer of API Bempedoic Acid:
Plot No. 34B, 40B & 60B,
India (IND).
Ezetimibe:
Zhejiang Tianyu Pharmaceutical Co., Ltd.
No.15, Donghai 5th Avenue, Zhejiang
Provincial Chemical and Medical Raw
Materials Base Linhai Zone, Taizhou City.
API Lot No. Bempedoic Acid:
HANPC21002
Ezetimibe:
10910-170403
Description of Pack Alu-Alu. Blisters with aluminum foil having
(Container closure system) leaflet and packed in unit carton
Real Time: 0, 3, 6, 8, 12, 16, 20, 24(Months)
Batch No. EZT-001 EZT-002
Batch Size 5000 tab 5000 tab
Manufacturing Date 08-2021 08-2021
Date of Initiation 08-2021 08-2021
No. of Batches 02
applications with stability study data of the their product:
firm (if any)
EMPAZON 10mg Tablets, EMPAZON 25mg
Tablets (Empagliflozin)
Dayzol 30mg Capsules, Dayzol 60mg

Capsules
(Dexlansoprazole)

presented in 307th meeting of Registration
Board held on 08-10th June, 2021.
Registration Board decided to approve
registration of

Dayzol 30mg Capsules, Dayzol 60mg

Capsules
(Dexlansoprazole)
by M/s. Horizon Healthcare (Pvt) Ltd. Lahore.

Manufacturer will place first three production
batches on long term stability studies
throughout proposed shelf life and on
accelerated studies for six months.
Following two observations were reported in
the report:
i.The HPLC software is 21 CFR
compliant.
ii. Audit trail on the testing reports of
EMPAZON 10mg and 25mg Tablets,
Dayzol 30mg and 60mg Capsules is
available.
iii. Adequate monitoring and control are
available for stability chamber. Chamber
are controlled and monitored through
software having alarm system for alerts as
well.
iv. Verification of performance of
dissolution test at buffer stage
pH 5.5 for Dayzol Capsules 30mg and
60mg.
Performance of dissolution test for
EMPAZON 10mg and 25mg Tablets with
revised specifications i.e not less than 80%
(Q) in 15minutes at initial and 01-month
time point.
2. Approval of API/ DML/GMP certificate of Bempedoic Acid:
API manufacturer issued by concerned Firm had provided valid GMP & DML
regulatory authority of country of origin. Certificate of M/s Metrochem API Private
Limited Issued by Drug Control
Administration Telangana India
DML Valid upto: 29-09-2024
GMP Valid upto: 29-10-2022
Ezetimibe:
Firm had provided valid GMP & DML
Certificate of M/s Zhejiang Tianyu
Pharmaceutical Co., Ltd.
Issued by Zhejiang Province Food & Drug
Administration Bureau
3. Documents for the procurement of API with Copy of commercial invoice attested by AD
approval from DRAP (in case of import). I&E DRAP, Lahore, has been submitted.
Bempedoic Acid:
Batch No. Invoic Quantity Date of
e No. Imported approva
l by
DRAP
HANPC2100 AE/21 2.0kgs 13-07-
2 /0576 2021
Ezetimibe:
Batch No. Invoic Quantity Date of
e No. Imported approval
by DRAP
10910- TYI21 0.150kgs 13-07-
170403 0608 2021
chromatograms,
etc.
testing
6. Record of Digital data logger for Firm has submitted record of Digital data
temperature and humidity monitoring of logger for temperature and humidity
stability chambers (real time and monitoring of stability chambers.
accelerated)
Innovator brand Nexlizet Tablet (180/10) approved in USFDA with the following indications,
warning and precautions:
Indications:
NEXLIZET, which contains an adenosine triphosphate-citrate lyase (ACL) inhibitor and a
cholesterol absorption inhibitor, is indicated as an adjunct to diet and maximally tolerated statin
therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established
atherosclerotic cardiovascular disease who require additional lowering of LDL-C.
Limitations of Use: The effect of NEXLIZET on cardiovascular morbidity and mortality has not
been determined.
Warning and Precautions:
Hyperuricemia: Elevations in serum uric acid have occurred. Assess uric acid levels periodically
as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment
with urate-lowering drugs as appropriate.
Tendon Rupture: Tendon rupture has occurred. Discontinue NEXLIZET at the first sign of tendon
rupture. Avoid NEXLIZET in patients who have a history of tendon disorders or tendon rupture.
Decision: Approved.
269. Name, address of Applicant / M/s Horizon Healthcare (Pvt.) Ltd.
Marketing Authorization Holder Plot no. 33 Sundar Industrial Estate Lahore.
☐ Importer
☐ Export sale
Bempex Tablet 180
name
Strength / concentration of drug of Each Film Coated Tablet contains:
Active Pharmaceutical ingredient Bempedoic Acid…….180mg
(API) per unit
Pharmaceutical form of applied drug white color, oval shaped, film coated tablets
Pharmacotherapeutic Group of (API) Bempedoic Acid: Lipid modifying agents, other
lipid modifying agents. Adenosine triphosphate
citrate lyase (ACL) inhibitor
As per innovator
specifications
Nexlitol Tablets 180mg approved by US-FDA
authorities
GMP status of the Finished product Last inspection report dated 18.06.2020 concluded
manufacturer good level of cGMP compliance.
Name and address of API Bempedoic Acid:

manufacturer. Metrochem API Private Limited, Unit-IV,
Plot No. 34B, 40B & 60B,
India (IND).
Module III (Drug Substance) The firm has submitted detail of General
information, General properties, Manufacturers,
description of manufacturing process and process
controls, Characterization, Impurities, Control of
drug substance, Reference standard or materials
drug substance.
Bempedoic Acid:
months
months
Batch No Accelerated Long Term
V/A070/44
V/A070/45
V/A070/46
Microbiological attribution, Manufacturer, Master
formulations, Description of Manufacturing
Process and Process Controls, Control of Critical
Steps and Intermediates, Process Validation and/
or Evaluation, Control of Excipients with
specification and Analytical methods, Control of
Drug Products including Finished product
specifications and test methods, validation of
Analytical methods, Batch analysis ,
Characterization of impurities, reference standard
or impurities, Container closure and stabilities
studies.
comparative dissolution profile against the brand leader that is Nexlitol Tablets
180mg approved by US-FDA by performing
quality tests (Identification, Assay, and
Dissolution. CDP has been performed against the
same brand that is Nexlitol Tablets 180mg
approved by US-FDA approved by US-FDA in
Acid media (pH 1.2) , Acetate Buffer (pH 4.5) &
Phosphate Buffer (pH 6.8)
validation/verification of product including Introduction, Verification of assay
method, Specificity, Accuracy, Precision,
Linearity concentration and peak range.
Manufacturer of API Bempedoic Acid:
Plot No. 34B, 40B & 60B,
India (IND).
API Lot No. Bempedoic Acid:
HANPC21002
Description of Pack Alu-Alu. Blisters with aluminum foil having leaflet
(Container closure system) and packed in unit carton
Real Time: 0, 3, 6, 8, 12, 16, 20, 24(Months)
Batch No. BD-001 BD-002 BD-003
No. of Batches 03
applications with stability study data of product:
the firm (if any)
Dayzol 30mg Capsules, Dayzol 60mg Capsules

(Dexlansoprazole)

held on 08-10th June, 2021.
Registration Board decided to approve registration
of

Dayzol 30mg Capsules, Dayzol 60mg Capsules

(Dexlansoprazole)
by M/s. Horizon Healthcare (Pvt) Ltd. Lahore.

Manufacturer will place first three production
batches on long term stability studies throughout
proposed shelf life and on accelerated studies for
six months.
Following two observations were reported in the
report:
v. The HPLC software is 21 CFR compliant.
vi. Audit trail on the testing reports of
EMPAZON 10mg and 25mg Tablets, Dayzol
30mg and 60mg Capsules is available.
vii. Adequate monitoring and control are available
for stability chamber. Chamber are controlled
and monitored through software having alarm
system for alerts as well.
viii. Verification of performance of dissolution test
at buffer stage
pH 5.5 for Dayzol Capsules 30mg and 60mg.
Performance of dissolution test for EMPAZON
10mg and 25mg Tablets with revised
specifications i.e not less than 80% (Q) in
15minutes at initial and 01-month time point.
2. Approval of API/ DML/GMP Bempedoic Acid:
certificate of API manufacturer issued Firm had provided valid GMP & DML Certificate
by concerned regulatory authority of of M/s Metrochem API Private Limited Issued by
country of origin. Drug Control Administration Telangana India
3. Documents for the procurement of API Copy of commercial invoice attested by AD I&E
with approval from DRAP (in case of DRAP, Lahore, has been submitted.
import). Bempedoic Acid:
Batch No. Invoice No. Quantit Date of
y approval
Importe by DRAP
d
HANPC21002 AE/21/0576 2.0kgs 13-07-
2021
sheets etc.
testing
temperature and humidity monitoring temperature and humidity monitoring of stability
of stability chambers (real time and chambers.
accelerated)
INDICATIONS AND USAGE
NEXLETOL is an adenosine triphosphate-citrate lyase (ACL) inhibitor indicated as an adjunct to
diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial
hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional
lowering of LDL-C.
Limitations of Use: The effect of NEXLETOL on cardiovascular morbidity and mortality has not
been determined.
DOSAGE AND ADMINISTRATION
Administer 180 mg orally once daily with or without food.
DOSAGE FORMS AND STRENGTHS Tablets….. 180 mg
CONTRAINDICATIONS None.
WARNINGS AND PRECAUTIONS
• Hyperuricemia: Elevations in serum uric acid have occurred. Assess uric acid levels periodically
as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment
with urate-lowering drugs as appropriate.
• Tendon Rupture: Tendon rupture has occurred. Discontinue NEXLETOL at the first sign of
tendon rupture. Avoid NEXLETOL in patients who have a history of tendon disorders or tendon
rupture.
Decision: Approved.
270. Name, address of Applicant / Kaizen Pharmaceuticals (Pvt.) Ltd., E-127-129,
Marketing Authorization Holder North Western Industrial Zone, Bin Qasim, Karachi-
75020, Pakistan.
Name, address of Manufacturing Kaizen Pharmaceuticals (Pvt.) Ltd., E-127-129,
site. North Western Industrial Zone, Bin Qasim, Karachi-
75020, Pakistan.
☐ Importer
Dy. No. and date of submission Dy. No. dated 20/08/2021
Teneglip 20mg tablet
brand name
Active Pharmaceutical ingredient 20mg of teneligliptin
(API) per unit
Pharmaceutical form of applied drug Red round biconcave film coated tablet
Pharmacotherapeutic Group of (API) Antidiabetic agent (dipeptidyl peptidase 4 inhibitors
or gliptins)
As per Innovator’s specifications
specifications
Proposed Pack size 10’s, 20’s, 30’s (as per SRO)
The status in reference regulatory Tenelia tablet 20mg tablet by Daiichi Sankyo Co.
authorities limited (Japan)
For generic drugs (me-too status) -------
approved.
Name and address of API Ami life sciences private limited, block
manufacturer. no.82/B,ECP road, AT and post:karakhadi-
391450,taluka:padre,district:Vadodara,gujarat,india
Batches:(TNG/RD/20170816,TNG/RD/20180816,
TNG/RD/20190816)
product.
comparative dissolution profile against the brand leader that is Tenelia 20mg tablet
by Daiichi Sankyo Co limited performing quality
tests (Identification, Assay, Dissolution, Uniformity
of dosage form).
is Tenelia 20mg tablet by Daiichi Sankyo Co limited
in Acid media (pH 0.1N HCl) & Phosphate Buffer
(pH 6.8, 4.5). The values for f1 and f2 are in the
acceptable range.
specificity,LOD,LOQ)
Manufacturer of API Ami lifesciences private limited, block no.82/B,ECP road, AT and
post:karakhadi-391450,taluka:padre,district:Vadodara,gujarat,india
API Lot No. N/A
Description of Pack PVC/ aluminum blister pack (10’s, 20’s, 30’s)
(Container closure
system)
Real Time: 0, 3, 6, 9, 12, 18(Months)
No. of Batches 03
2. Approval of API/ DML/GMP S-GMP/1704043 issued by primal enterprises
certificate of API manufacturer issued limited province FDA valid till 23-04-2019
country of origin.
3. Documents for the procurement of Form 6 license no. 0159 dated 12-01-2018
API with approval from DRAP (in
case of import).

sheets etc.
on product testing
accelerated)
Sr.no Observations/Shortcoming Reply of the Firm
.
1. Submit differential fee for the Firm submitted the fee of Rs.10,000/- vide
registration of applied product, since slip no. 66093415 dated30-09-2022
the notification for revision of fee vide
SRO No. F.7-11/2012-B&A/DRA was
published on 7th May 2021 while this
application was received in R&I
section of DRAP on 20th Aug, 2021.
2. Submit copies of the Drug substance Firm submitted the analytical verification
specifications and analytical report of drug substance by drug product
procedures used for routine testing of manufacturer.
Pharmaceutical Ingredient by drug
product manufacturer in section
3.2.S.4.1 as per the guidance document
approved by Registration Board.
3. Submit stability data of drug substance Submitted
till the claimed shelf life, since,
according to the submitted data, study
completion date is 16-09-2021.
4. Justify the dissolution acceptance Firm replied that Dissolution of product
criteria specified in section 3.2. P.5.1 specification is NLT 75% at 60min. This time
i.e. “NLT 75% of labelled claim within point is verified in CDP in which 75%+Q
60 minutes” relative to the result of dissolution is achieved at 60 min in all the 3
dissolution testing of three trial batches BCS dissolution medium while more than
of drug product which revealed that 90% of drug is released at only one time point
more than 90% of drug release at each i.e 60min and 75%+Q drug is also released in
time point in all three batches. Further, water AT 45 min that’s why water was taken
justify, the setting of dissolution as dissolution medium which is in accordance
acceptance criteria in the light of with the 293rd meeting of the Registration
general guidance of dissolution Board.
specification approved in 293rd meeting
of Registration Board.
5. According to the procedure of Firm replied that as Teneligliptin dissolution
dissolution test submitted in section is not described in FDA guidelines then the
3.2. P.5.2 the dissolution medium is dissolution parameters are selected using CDP
purified water, justify the choice of criteria. CDP criteria were conducted in the 3
medium with the international BCS dissolution medium (pH 1.2-6.8) and
reference/literature. also in water. In the 3 BCS dissolution
medium dissolution 75%+Q was attained in
phosphate buffer 6.8 at 45 min time point but
this was at border line. When we performed in
water than dissolution was attained from
88.4% to 100.72% for test product at 45 min
and 92.18% to 99.73% for innovator product.
That’s why CDP shows dissolution of both
27% at 15 min, 50% at 30 min, 75% at 45 min
and more than 90% at 60 min.
6. According the given procedure of assay Firm replied that It was a typographic error
in section 3.2.P.5.2, injection volume which is now corrected
should be 10µl and the flow rate should
be set at 1.4ml/min, while the
chromatogram of analytical method
validation studies reveals that the
injection volume was 20µl and the flow
rate maintained at 1.0ml/min.
Justification is required for changing
the chromatographic conditions while
performing the analytical method
validation studies of drug product from
that specified in section 3.2. P.5.2.
7. Clarify, either the assay results Firm replied that Results are of teneligliptin
mentioned in stability data sheets are on as is basis.
the content of teneligliptin or the
content of hydrobromide hydrate salt
form of active. Similarly, dissolution
results were mentioned without the
time point at which the results are
obtained and the acceptance limit were
also mentioned without the acceptable
time frame.
Decision: Deferred for justification of dissolution parameter considering USP general
chapter 1092 and innovator product literature.
Form 5-D Cases Received with Stability Data

271. Name and address of manufacturer / "M/s. Hilton Pharma (Pvt.) Ltd. Plot No. 13-14 &
Applicant 15, Sector-15, Korangi, Industrial Area, Karachi.”
Brand Name +Dosage Form + Maxit Sachets 50mg Powder for Oral Solution
Strength
Composition Each sachet contains:
Diclofenac potassium …… 50mg
(Pack size: 10’s, 20’s & 30’s)
Pharmacological Group Non-Steroidal Anti-inflammatory Drug
Type of Form Form 5 D
Finished product Specifications USP specification
Approval status of product in Voltfast Sachet 50mg Powder for Oral Solution by
Reference Regulator Authorities M/s Mipharm S.p.A, Millan Italy for Novartis
Pharma AG, Basle, Switzerland, FDA Approved.
Me-too status Not Available
GMP status Section for Sachet (General) was granted after
renewal of Drug Manufacturing Licence
inspection vide letter No.
F. 2-14/85-Lic (Vol-V)
Dated: 30/06/2020
Drug Maxit Sachets 50mg (Diclofenac Potassium)
Name of "M/s. Hilton Pharma (Pvt.) Ltd. Plot No. 13-14 & 15, Sector-15, Korangi,
Manufacturer Industrial Area, Karachi.”
Manufacturer of API M/s. Aarti Drug Limited, Plot No. G-60, M.I.D.C., Tarapur, Boisar, Tal,
Palghar. Dist. Thane, India. Tel.: 9970052099
API Lot No. As per invoice attested by DRAP batch no. DFK/10060080 has been
imported
Description of Pack
(Container closure Alu-Alu Paper foil
system)
Time Period Real time: MAX-148-05/21 (6 months),
MAX-157-06/21 (6 months),
MAX-158-07/21 (6 months),
Frequency Real Time: 0, 3, 6, 9, 12, 18, 24
Accelerated: 0, 3, 6
Batch No. MAX-148-05/21 MAX-157-06/21 MAX-158-07/21
Batch Size 2.0 Kg (2,222 2.0 Kg (2,222 Sachets) 2.0 Kg (2,222 Sachets)
Sachets)
No. of Batches 03
Date of Submission 21-08-2017
No.
applications with stability study data product “HILVEL 400mg + 100mg (Sofosbuvir
of the firm +Velpatasvir)”, which was conducted on 14th
December, 2017 and was presented in 277th
meeting of Registration Board held on 27-29th
December, 2017.
of “HILVEL 400mg / 100mg (Sofosbuvir +
Velpatasvir” by M/s. Hilton Pharma (Pvt.) Ltd.,
Karachi. Manufacturer will place first three
production batches on long term stability studies
throughout proposed shelf life and on accelerated
studies for six months.
report:
i. The HPLC software is 21 CFR compliant.
ii. Audit trail on the testing reports of Hilvel
Tablets 400mg+100mg is available.
stability chamber. Chamber are controlled and
for alerts as well.
16. Certificate of Analysis of API from
both API Manufacturer and Finished Submitted
17. Method used for analysis of API from
Product manufacturer
18. Stability study data of API from API
manufacturer
months
months
Diclofenac Potassium:
Batches #: (DFK/10070024, DFK/10070025,
DFK/10070026)
19. Approval of API/ DML/GMP Copy of GMP certificate No.
certificate of API manufacturer issued Diclofenac Potassium: No: 6102298 issued by
by concerned regulatory authority of Food and Drugs Administration, KONKAN
country of origin. Division.
20. Documents for the procurement of The firm has provided the copy of procurement
API with approval from DRAP (in invoices of API; details are as follow.
case of import).
API Name Invoice No. & Date
EXP/845/20-21
Diclofenac Potassium
01/07/2020
Yes
stability study
23. Drug-excipients compatibility studies
NA
(where applicable)
24. Complete batch manufacturing record The firm has been submitted copy of Trial
of three stability batches. batch manufacturing record.
Maxit Sachet 50mg
Started
MAX-148- 2.0 Kg (2,222 20.07.2021
05/21 Sachets)
MAX-157- 2.0 Kg (2,222 20.07.2021
06/21 Sachets)
MAX-158- 2.0 Kg (2,222 20.07.2021
07/21 Sachets)
Submitted
Yes
on product testing.
Submitted
accelerated)
Sr.no. Shortcoming/Deficiencies Reply of the Firm
1. Justify the finished product Firm has submitted the revised finished
specifications as “In-house product specification as per USP monograph
specifications” since the drug product of Diclofenac potassium for oral solution
monograph is available in USP along with fee of RS. 7,500/- paid vide
Pharmacopoeia. Revise your challan no.297845546. dated 24-10-2022
specifications along with submission of
requisite fee.
2. Submit pharmaceutical equivalence Firm submit pharmaceutical equivalence
report performed against the report performed against Volfast Sachet
innovator/reference product. 50mg of M/s. Novartis Pharma Batch no.
AMPA2T2.
Decision: Approved. Firm shall submit perfromance of stability studies at athe next time
point of long term stability study as per USP monograph of “Diclofenac potassium for oral
solution” before issuance of registration letter.
Manufacturer will place first three production batches on long term stability studies
throughout proposed shelf life and on accelerated studies for six months.
Brand Name +Dosage Form + Ertisit Tablets 5mg + 100mg
Strength
Composition Each film-coated tablet contains:
Ertugliflozin L-Pyroglutamic acid equivalent to
Ertugliflozin … 5 mg,
Sitagliptin Phosphate monohydrate eq. to
Sitagliptin … 100 mg
Diary No. Date of R& I & fee Dy. No.16316 dated 03-05-2018 Rs.50,000/-
Type of Form Form 5-D
Finished product Specifications Innovator’s Specification
Pack size & Demanded Price As per SRO(Pack size: 7’s, 10’s, 14’s, 28’s &
30’s)
Approval status of product in Steglujan Tablets 5mg/100mg by M/s Merck
Reference Regulator Authorities Sharp & Dohme B.V., FDA Approved.
F. 2-14/85-Lic (Vol-V)
Dated: 30/06/2020
Drug Ertisit Tablets 5mg + 100mg
Ertugliflozin L-Pyroglutamic acid & Sitagliptin Phosphate Monohydrate)
Manufacturer of API Ertugliflozin L-Pyroglutamic acid
M/s. Chifeng Arker Pharmaceutical Technology Co., Ltd. No. 8 Mysun
Street, Hongshan Economic Development Zone, Chifeng, Inner Mongolia,
China
Sitagliptin Phosphate
M/s. Ruyuan HEC Pharm Co., Ltd. Xiaba Development Zone, Ruyuan
County, Shaoguan City, Guangdong Province, P.R.China Postal code:
512721
API Lot No. As per invoice attested by DRAP for Ertugliflozin L-Pyroglutamic acid for
batch no. D84-201101, Sitagliptin Phosphate for batch no. 1827-0001-
20091 have been imported.
Description of Pack
(Container closure Alu-Alu foil
system)
Time Period Real time: ERS-041-02/21 (6 months)
ERS-042-03/21 (6 months)
ERS-043-04/21 (6 months)
Batch No. ERS-041-02/21 ERS-042-03/21 ERS-043-04/21
Batch Size 1000 G (2,500 1000 G (2,500 Tablets) 1000 G (2,500 Tablets)
Tablets)
No. of Batches 03
Date of Submission 06.05.2022
No.
December, 2017.
report:
iii. The HPLC software is 21 CFR compliant.
iv. Audit trail on the testing reports of Hilvel
for alerts as well.
4. Stability study data of API from API Stability study storage conditions:
manufacturer Long term: 30°C ± 2°C / 65% ± 5%RH for 06
months
months
Ertugliflozin L-Pyroglutamic acid:
Batches #: (D84-161201, D84-161202,
D84-170101)
Sitagliptin Phosphate:
Batches #: (STP-201312001, STP-201312002,
STP-201401001)
5. Approval of API/ DML/GMP
Submitted
country of origin.
case of import).
Ertugliflozin PSPW-201113
LPGA 13.11.2020
Sitagliptin C05S05ZEP200933
Phosphate 26.10.2020
Yes
stability study
Not Applicable
(where applicable)
Ertisit Tablets 5mg/100mg
ERS-041- 1000 G 04.02.2021
02/21 (2,500 Tab.)
ERS-042- 1000 G 04.02.2021
03/21 (2,500 Tab.)
ERS-043- 1000 G 04.02.2021
04/21 (2,500 Tab.)
Submitted
Yes
on product testing.
Submitted
accelerated)
Sr.n Shortcoming/Deficiencies Reply of the Firm
o.
1. Submit the translated version and Firm submitted the Drug Manufacturing license
instant API related GMP certificate of API manufacturer Ertugliflozin L-PGA which
of drug substance ertugliflozin L- is valid till 28-12-2025
Pyroglutamic acid.
2. Submit stability study data of both Firm has submitted stability data of both drug
API from API manufacturer substance.
3. Submit pharmaceutical equivalence Firm has submitted pharmaceutical equivalence
report performed against the report performed against Steglujan Tablet
innovator/reference product. 5mg/100mg Batch no. U001351.
4. Sample solution preparation of assay Revised analytical procedure of finished product
testing of finished product did not has submitted by the firm.
specify the concentration of
ertugliflozin and sitagliptin in the
final dilution of sample solution.
5. Justify the acceptance criteria of Firm has revised the acceptance limit of
disintegration test adapted by you for Disintegration test from 15 minutes to 5minutes
both strength i.e. NMT 15 minutes in for core tablet and 10 minutes for film coated
the light of review literature of tablet.
innovator brand approved in
USFDA. Since the review report of
innovator brand reveal that
disintegration is the discriminating
test for the applied product, so more
stringent disintegration acceptance
limit has been recommended for both
strengths.
Brand Name +Dosage Form + Ertisit Tablets 15mg + 100mg
Strength
Ertugliflozin L-Pyroglutamic acid equivalent to
Ertugliflozin … 15 mg,
Sitagliptin Phosphate monohydrate eq. to
Sitagliptin … 100 mg
Diary No. Date of R& I & fee Dy. No.16316 dated 03-05-2018 Rs.50,000/-
Type of Form Form 5-F
Pack size & Demanded Price As per SRO(Pack size: 7’s, 10’s, 14’s, 28’s &
30’s)
Approval status of product in Steglujan Tablets 15mg/100mg by M/s Merck
Reference Regulator Authorities Sharp & Dohme B.V., FDA Approved.
F. 2-14/85-Lic (Vol-V)
Dated: 30/06/2020
Drug Ertisit Tablets 15mg + 100mg
Ertugliflozin L-Pyroglutamic acid & Sitagliptin Phosphate Monohydrate)
Manufacturer of API Ertugliflozin L-Pyroglutamic acid
M/s. Chifeng Arker Pharmaceutical Technology Co., Ltd. No. 8 Mysun
Street, Hongshan Economic Development Zone, Chifeng, Inner Mongolia,
China
Sitagliptin Phosphate
M/s. Ruyuan HEC Pharm Co., Ltd. Xiaba Development Zone, Ruyuan
County, Shaoguan City, Guangdong Province, P.R.China Postal code:
512721
API Lot No. As per invoice attested by DRAP for Ertugliflozin L-Pyroglutamic acid for
batch no. D84-201101, Sitagliptin Phosphate for batch no. 1827-0001-
20091 have been imported.
Description of Pack
system)
Time Period Real time: ERS-044-03/21 (6 months)
ERS-045-04/21 (6 months)
ERS-046-05/21 (6 months)
Batch No. ERS-044-03/21 ERS-045-04/21 ERS-046-05/21
Batch Size 1000 G (2,500 1000 G (2,500 Tablets) 1000 G (2,500 Tablets)
Tablets)
No. of Batches 03
No.
December, 2017.
report:
v. The HPLC software is 21 CFR compliant.
vi. Audit trail on the testing reports of Hilvel
for alerts as well.
4. Stability study data of API from API Stability study storage conditions:
manufacturer Long term: 30°C ± 2°C / 65% ± 5%RH for 06
months
months
Ertugliflozin L-Pyroglutamic acid:
Batches #: (D84-161201, D84-161202,
D84-170101)
Sitagliptin Phosphate:
Batches #: (STP-201312001, STP-201312002,
STP-201401001)
Submitted
country of origin.
case of import).
Ertugliflozin PSPW-201113
LPGA 13.11.2020
Sitagliptin C05S05ZEP200933
Phosphate 26.10.2020
Yes
stability study
Not Applicable
(where applicable)
Ertisit Tablets 15mg/100mg
ERS-044- 1000 G 09.02.2021
03/21 (2,500 Tab.)
ERS-045- 1000 G 09.02.2021
04/21 (2,500 Tab.)
ERS-046- 1000 G 09.02.2021
05/21 (2,500 Tab.)
Submitted
Yes
on product testing.
Submitted
accelerated)
Sr.no. Shortcoming/Deficiencies Reply of the Firm
1. Submit the translated version and Firm submitted the Drug Manufacturing
instant API related GMP certificate of license of API manufacturer Ertugliflozin L-
drug substance ertugliflozin L- PGA which is valid till 28-12-2025
Pyroglutamic acid.
2. Submit stability study data of both API Firm has submitted stability data of both drug
from API manufacturer substance.
3. Submit pharmaceutical equivalence Firm has submitted pharmaceutical
report performed against the equivalence report performed against
innovator/reference product. Steglujan Tablet 5mg/100mg Batch no.
U001351.
4. Sample solution preparation of assay Revised analytical procedure of finished
testing of finished product did not product has submitted by the firm.
specify the concentration of
ertugliflozin and sitagliptin in the final
dilution of sample solution.
5. Justify the acceptance criteria of Firm has revised the acceptance limit of
disintegration test adapted by you for Disintegration test from 15 minutes to
both strength i.e. NMT 15 minutes in 5minutes for core tablet and 10 minutes for
the light of review literature of film coated tablet.
innovator brand approved in USFDA.
Since the review report of innovator
brand reveal that disintegration is the
discriminating test for the applied
product, so more stringent
disintegration acceptance limit has
been recommended for both strengths.
Brand Name +Dosage Form + Golix Tablets 200mg
Strength
Elagolix Sodium equivalent to Elagolix …… 200mg
Diary No. Date of R& I & fee Dy.No.43243 dated 19-12-2018 Rs.50,000/-
Pharmacological Group Gonadotropin-releasing hormone (GnRH)
receptor antagonist
Pack size & Demanded Price As per SRO(Pack size: 7’s, 14’s & 28’s)
Approval status of product in Orilissa Tablets 200mg by M/s AbbVie Inc.
Reference Regulator Authorities North Chicago, IL 60064, FDA Approved.
F. 2-14/85-Lic (Vol-V)
Dated: 30/06/2020
Drug Golix Tablets 200mg (Elagolix Sodium)
Manufacturer of API M/s. Aurisco Pharmaceutical Co., Ltd., Badu Industrial Park Zone, Tiantai
Country, Zhejiang Province 317200, P.R. China
API Lot No. As per invoice attested by DRAP batch no. ELS-201101P has been
imported
Description of Pack
system)
Time Period Real time: GOL-087-02/21 (6 months),
GOL-088-03/21 (6 months),
GOL-089-04/21 (6 months)
Batch No. GOL-087-02/21 GOL-088-03/21 GOL-089-04/21
Batch Size 900 G (1500 Tablets) 900 G (1500 Tablets) 900 G (2,000 Tablets)
No. of Batches 03
No.
December, 2017.
report:
vii. The HPLC software is 21 CFR compliant.
viii. Audit trail on the testing reports of Hilvel
for alerts as well.
4. Stability study data of API from API Stability study conditions:
manufacturer Long term: 2-8°C for 09 months
months
Elagolix Sodium:
Batches #: (200301P, 200302P, 200303P)
Copy of GMP certificate No.
Elagolix Sodium: No: ZJ20170053 issued by China
food and drug administration.
country of origin.
case of import).
Elagolix 20T-442
Sodium 17.12.2020
Yes
stability study
Not Applicable
(where applicable)
Golix Tablets 200mg
Started
GOL-087- 900 G (1500 17.03.2021
02/21 Tablets)
GOL-088- 900 G (1500 17.03.2021
03/21 Tablets)
GOL-089- 900 G (1500 18.03.2021
04/21 Tablets)
Submitted
Yes
on product testing.
Submitted
accelerated)
Sr.no. Shortcoming/Deficiencies Reply of Firm
1. According to the assay method by drug Firm replied that “ assay was carried out
substance manufacturer the retention with in used column C8 ,water symmetry
time of major peak is about 13.5 minutes, and retention time was achieved 17.6
than justify the retention time of about minutes as compared to 13.5 minutes due to
17.6 minutes of major peak as evident changes in column.
from the submitted chromatogram of
assay of drug substance by drug product
manufacturer, despite of using same
chromatographic condition, gradient
program and mobile phase as of drug
substance manufacturer.
Brand Name +Dosage Form + Golix Tablets 150mg
Strength
Elagolix Sodium equivalent to Elagolix …… 150mg
Diary No. Date of R& I & fee Dy.No.43242 dated 19-12-2018 Rs. 50,000/-
Pharmacological Group Gonadotropin-releasing hormone (GnRH)
receptor antagonist
Pack size & Demanded Price As per SRO(Pack size: 7’s, 14’s & 28’s)
Approval status of product in Orilissa Tablets 150mg by M/s AbbVie Inc.
Reference Regulator Authorities North Chicago, IL 60064, FDA Approved.
F. 2-14/85-Lic (Vol-V)
Dated: 30/06/2020
Drug Golix Tablets 150mg (Elagolix Sodium)
Manufacturer of API M/s. Aurisco Pharmaceutical Co., Ltd., Badu Industrial Park Zone, Tiantai
Country, Zhejiang Province 317200, P.R. China
API Lot No. As per invoice attested by DRAP batch no. ELS-201101P has been
imported
Description of Pack
system)
Time Period Real time: GOL-084-02/21 (6 months),
GOL-085-03/21 (6 months),
GOL-086-04/21 (6 months)
Batch No. GOL-084-02/21 GOL-085-03/21 GOL-086-04/21
Batch Size 900 G (2,000 Tablets) 900 G (2,000 Tablets) 900 G (2,000 Tablets)
No. of Batches 03
No.
December, 2017.
report:
ix. The HPLC software is 21 CFR compliant.
x. Audit trail on the testing reports of Hilvel
for alerts as well.
4. Stability study data of API from API Stability study conditions:
manufacturer Long term: 2-8°C for 09 months
months
Elagolix Sodium:
Batches #: (200301P, 200302P, 200303P)
Copy of GMP certificate No.
Elagolix Sodium: No: ZJ20170053 issued by China
food and drug administration.
country of origin.
case of import).
Elagolix 20T-442
Sodium 17.12.2020
Yes
stability study
Not Applicable
(where applicable)
Golix Tablets 150mg
Started
GOL-084- 900 G (2,000 08.03.2021
02/21 Tablets)
GOL-085- 900 G (2,000 08.03.2021
03/21 Tablets)
GOL-086- 900 G (2,000 09.03.2021
04/21 Tablets)
11. Record of comparative dissolution Submitted (performed against Orillisa Tablet
data (where applicable) 150mg Batch no.2155200)
Yes
on product testing.
Submitted
accelerated)
Sr.no. Shortcoming/Deficiencies Reply of Firm
2. According to the assay method by drug Firm replied that “ assay was carried out
substance manufacturer the retention with in used column C8 ,water symmetry
time of major peak is about 13.5 minutes, and retention time was achieved 17.6
than justify the retention time of about minutes as compared to 13.5 minutes due to
17.6 minutes of major peak as evident changes in column.
from the submitted chromatogram of
assay of drug substance by drug product
manufacturer, despite of using same
chromatographic condition, gradient
program and mobile phase as of drug
substance manufacturer.
276. Name and address of manufacturer / M/s. Otsuka Pakistan Ltd.
Applicant F/4-9, Hub Industrial Trading Estate, Distt.
Lasbella, Balochistan.
Brand Name +Dosage Form + Ibufen 400mg I.V Infusion
Strength
Ibuprofen…..400mg
Diary No. Date of R& I & fee Dy.No. 24085 Dated 11-07-2018
Rs. 20,000/- Dated 11-07-2018 (DSN: 0741916)
Type of Form Form 5
Pack size & Demanded Price 100ml: Rs. 312/-
Approval status of product in Approved in Germany. (Ibuprofen B. Braun 400
Reference Regulatory Authorities mg/100ml solution for infusion)
Me-too status …..
GMP status GMP compliance level is rated as Satisfactory.
Inspection conducted on 15th March 2022.
Remarks Response
Evidence of applied formulation/drug Firm has submitted evidence of IX IV
already approved by DRAP (generic / me- Infusion of M/s. Searl IV solutions (M-278).
too status) alongwith registration number,
Evidence of reference product packed in Applicant has submitted leaflet of of
LDPE bottle. Ibuprofen 400mg solution of B.Barun,
Germany with highlighted the availability in
LDPE bottle.
Approval of section/manufacturing Applicant has submitted a letter of CLB
facility by the Central Licensing Board. bearing a No. F. 2-1/879-Lic (Vol-II) dated
However, you may submit panel 1st July, 2015 showing following sections:
inspection report for renewal of DML • Plabottle infusion section 500ml
verifying the section/manufacturing (Large Volume Parenteral).
facility. • Plabottle (Small Volume Parenteral).
• Aseptically filled injection Plabottle
(Plastic bottles).
Decision of 293rd meeting of Registration Board:

Registration Board defer the case for submission of stability studies of applied formulation
as per guidelines provided in 251st & later amended in 278th meeting of Registration Board.
Drug Ibufen
Name of M/s. Otsuka Pakistan Ltd.
Manufacturer F/4-9, Hub Industrial Trading Estate, Distt. Lasbella, Balochistan.
Manufacturer of API Hubei Granules- Biocause Pharmaceutical Company Ltd.,
122 Yangwan Road, China - 448000
API Lot No. As per invoice attested by DRAP batch no. C100-1901237M, C100-
1901449M, C100-1901453M has been imported
Description of Pack
(Container closure Plastic bottles of 100ml
system)
Frequency IBH01D19 IB001B20 IB002B20
Accelerated:0,1,2,3,4 Accelerated:0,1,2,3,4 Accelerated:0,1,2,3,4
,6 (month) ,6 (month) ,6 (month)
Real Time: Real Time: Real Time:
0,3,6,9,12,18,24,36 0,3,6,9,12,18,24,36 0,3,6,9,12,18,24,36
(month) (month) (month)
Batch No. IBH01D19 IB001B20 IB002B20
Batch Size 100 Bottles 24,000 Bottles 24,000 Bottles
No. of Batches 03
applications with stability study data of None
the firm
both API Manufacturer and Finished COA of API from API Manufacturer and
Product manufacturer. Finished Product manufacturer has been
submitted.
3. Method used for analysis of API from Method used for analysis of API from API
both API Manufacturer and Finished Manufacturer and Finished Product
Product manufacturer manufacturer has been submitted.
manufacturer Months (40°C ± 2°C & 75±5%RH) & long term,
72 Months (30°C ± 2°C & 65±5%RH) stability
study reports of 03 batches.
certificate of API manufacturer issued Firm has submitted copy of GMP certificate of
by concerned regulatory authority of Drug Substance manufacturer.
country of origin.
6. Documents for the procurement of API Copy of Commercial Invoice no. GIB19017074
with approval from DRAP (in case of Dated: JAN.29, 2019 from Hubei Granules-
import). Biocause Pharmaceutical Company Ltd.,
122 Yangwan Road, Jingmen City, Hubei
Province, China attested by AD DRAP (Quetta)
dated 17-03-2019 has been submitted.
Yes
stability study
N/A
(where applicable)
10. Complete batch manufacturing record The firm has submitted copy of Trial
Ibufen 400mg Injection
Mfg.
Batch No. Bach size
Started
IBH01D19 100 Bottles 2019.04.08
24,000
IB001B20 2020.02.14
Bottles
24,000
IB002B20 2020.02.14
Bottles
(where applicable) N/A

Yes
21CFR & audit trail reports on product Certificate of compliance submitted.
testing.
Yes
accelerated)
. comings
1. Submit real time stability data of drug Firm submitted the stability data of drug
substance as per zone-IV-A condition or substance performed at zone iv-a condition.
submit long term stability studies data of
the drug product for 6 months along with
degradation studies as per decision of
registration Board in its 297th meeting.
Cases of New Licenses received on FORM 5-F

277. Name, address of Applicant / M/s Pinnacle Biotech (Pvt.) Ltd.
Marketing Authorization Holder
Name, address of Manufacturing site. M/s Pinnacle Biotech (Pvt.) Ltd.
Plot No. FD-49-A8, FD-50-A8, FD-51-A8,
Korangi Creek Industrial Park, Karachi.
☐ Importer
☐ Export sale
Empaxo 10mg Tablets
name
Active Pharmaceutical ingredient (API) Empagliflozin………...….10mg
per unit
Pharmaceutical form of applied drug White, round, film coated tablet plain on both
sides.
Pharmacotherapeutic Group of (API) Sodium-glucose co-transporter 2 (SGLT2)
inhibitors
Innovator’s Specs
specifications
The status in reference regulatory JARDIANCE 10mg Tablet by BOEHRINGER
authorities INGELHEIM PHARMACEUTICALS INC,
USFDA Approved.
For generic drugs (me-too status) Diampa 10mg Tablet by Getz Pharma Pakistan
(Pvt.) Ltd.
manufacturer Tablet (general), Capsule (general), Sachet
(general) and Research and Development
Laboratory section is approved.
Name and address of API manufacturer. API: Empagliflozin
M/s. Fuxin Long Rui Pharmaceutical Co. Ltd.
Address: Fluoride Industrial Park, Fumeng

County (Yi Ma Tu), Fuxin City, Liaoning
Province -123000, China
Module III (Drug Substance) Firm has submitted drug substance data for
sources related to nomenclature, structure,
Stability studies API: Empagliflozin.
Firm has submitted signed and stamped stability
data sheets as per zone IV-A in which real time
stability data
Real time: 30°C ± 2°C / 65% ± 5%RH
Pharmaceutical equivalence and Pharmaceutical equivalence studies with
comparative dissolution profile reference product i.e., Jardiance 10mg Tablet
validation/verification of product including System Suitability, Linearity,
Accuracy, precision, Specificity, Limit of
Quantification, Limit of Detection, Robustness.
Manufacturer of API API: Empagliflozin
Address: Fluoride Industrial Park, Fumeng County (Yi Ma Tu),

Fuxin City, Liaoning Province -123000, China.
API Lot No. API: Empagliflozin.
H-E-20210605-D01-E06-02
Description of Pack
Batch No. 22TTEMP002 22TTEMP003 22TTEMP004
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate License Number: LIAO 20150233 Issue Date:
of API manufacturer issued by May 18, 2020
concerned regulatory authority of
country of origin.
with approval from DRAP (in case of • Permission to import different APIs including
import). Empagliflozin for the purpose of test/analysis
and stability studies is granted.
• License No.3942/21/DRAP-AD-CD(I&E)
dated 10/12/2021
sheets etc.
testing
accelerated)
1. Submit data in section 3.2.S.4.3 as per the Firm submit the requisite document.
guidance document approved by
Registration Board which specifies that
“Analytical Method Verification studies
by the Drug Product manufacturer for both
compendial as well as non-compendial
drug substance(s) shall be submitted”
Further specify how the testing of drug
substance was carried out without
2. Provide copy of Batch Manufacturing Firm submitted the BMR of all three trail
Record (BMR) for all the batches of drug batches.
provided in Module 3 section 3.2. P.8.3.
278. Name, address of Applicant / Marketing M/s Pinnacle Biotech (Pvt.) Ltd.
Name, address of Manufacturing site. M/s Pinnacle Biotech (Pvt.) Ltd.
Plot No. FD-49-A8, FD-50-A8, FD-51-A8,
Korangi Creek Industrial Park, Karachi.
☐ Importer
giver)
☐ Export sale
Empaxo 25mg Tablets
name
Active Pharmaceutical ingredient (API) Empagliflozin………...….25mg
per unit
Pharmaceutical form of applied drug Yellow color, round shape, film coated tablet
plain on both sides.
Pharmacotherapeutic Group of (API) Sodium-glucose co-transporter 2 (SGLT2)
inhibitors
Innovator’s Specs
specifications
The status in reference regulatory JARDIANCE 25mg Tablet by BOEHRINGER
authorities INGELHEIM PHARMACEUTICALS INC,
USFDA Approved.
For generic drugs (me-too status) Diampa 25mg Tablet by Getz Pharma Pakistan
(Pvt.) Ltd.
manufacturer Tablet (general), Capsule (general), Sachet
(general) and Research and Development
Laboratory section is approved.
Name and address of API manufacturer. API: Empagliflozin
Address: Fluoride Industrial Park, Fumeng

County (Yi Ma Tu), Fuxin City, Liaoning
Province -123000, China
submitted.
Module III (Drug Substance) Firm has submitted drug substance data for
sources related to nomenclature, structure,
Stability studies API: Empagliflozin.
Firm has submitted signed and stamped
stability data sheets as per zone IV-A in which
real time stability data
Real time: 30°C ± 2°C / 65% ± 5%RH
Pharmaceutical equivalence and Pharmaceutical equivalence studies with
comparative dissolution profile reference product i.e., Xenglu-Met 12.5mg-
1000mg Tablet.
of product including System Suitability, Linearity,
Accuracy, precision, Specificity, Limit of
Quantification, Limit of Detection, Robustness.
Manufacturer of API API: Empagliflozin
Address: Fluoride Industrial Park, Fumeng County (Yi Ma Tu),
Fuxin City, Liaoning Province -123000, China
API Lot No. API: Empagliflozin.
H-E-20210605-D01-E06-02
Description of Pack
Batch No. 22TTEMP001 22TTEMP002 22TTEMP003
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate License Number: LIAO 20150233 Issue Date:
of API manufacturer issued by concerned May 18, 2020
with approval from DRAP (in case of • Permission to import different APIs including
import). Empagliflozin for the purpose of test/analysis
• License No.3942/21/DRAP-AD-CD(I&E)
dated 10/12/2021
chromatograms,
sheets etc.
testing
accelerated)
1. Submit data in section 3.2.S.4.3 as per the Firm submit the requisite document.
guidance document approved by
“Analytical Method Verification studies
compendial as well as non-compendial
drug substance(s) shall be submitted”
2. Provide copy of Batch Manufacturing Firm submitted the BMR of all three trail
Record (BMR) for all the batches of drug batches.
provided in Module 3 section 3.2. P.8.3.
279. Name, address of Applicant / Marketing M/S Qadir Pharmaceuticals
Authorization Holder 6-Km G.T Road Wazirabad Sialkot
Veerum, Fateh Garh Sahuwala Road Sailkot
Pakistan.
Name, address of Manufacturing site. M/S Qadir Pharmaceuticals
6-Km G.T Road Wazirabad Sialkot
Pakistan.
☐ Importer
giver)
☐ Export sale
Cain-Q 1% Injection
name
Strength / concentration of drug of Each ampoule 2ml contains:
Active Pharmaceutical ingredient (API) Lidocaine HCl…………20mg
per unit
Pharmaceutical form of applied drug 2ml Ampoule for IM
Pharmacotherapeutic Group of (API) Local or regional anesthesia
BP Spec
specifications
The status in reference regulatory Lidocaine HCl(1%) injection(IM) by M/s
authorities Mercury Pharma B. Braun Melsungen AG,
Mistelweg 2, 12357 Berlin, Germany.
For generic drugs (me-too status) Global Pharmaceuticals
manufacturer Tablet (General) ,Capsule (General), Capsule
(cephalosporin) Oral Dry Suspension
(cephalosporin) Oral liquid, liquid injectable
vial& Ampoule(Gerenal) Dry powder
Injectable(Gerenal) section approved.
Name and address of API manufacturer. Gufic Biosciences Limited Subhash Road-A,
Vile Parle (E), Mumbai-400 057,India.
submitted.
Module III (Drug Substance) Official monograph of Lidocain Hydrochloride
is present in BP. The firm as submitted detail of
drug substance
months
months
Batches: (1884, 1885, 1886)
Lidocain 2ml Injection manufacture by Global
specificty.
Manufacturer of API GUFIC BIOSCIENCES LIMITED SUBHASH
ROAD-A, VILE PARLE (E), MUMBAI-400 057,
INDIA.
TEL :+91- 22-56919191
FAX : +91-22-26169008
Email :dhapalapur@guficbio.com
API Lot No. 2725
Description of Pack
(Container closure Liquid for injection filled in glass ampoule Type 1 (1×1’s)
system)
Batch No. T-001 T-002 T-003
Batch Size 1000 Amp 1000 Amp 1000 Amp
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate Submitted
of API manufacturer issued by concerned
3. Documents for the procurement of API Submitted

import).

chromatograms,
sheets etc.
testing
accelerated)
S.no. Sections Observations/Deficiencies/ Short- Reply of the Firm
comings
1. 3.2. Provide detailed analytical procedures Submitted
S.4.2 used for the testing of drug substance
by drug product manufacturer.
2. 3.2. Provide analytical Method validation Submitted
S.4.3 studies of drug substance performed
by the drug product manufacturer.
3. 3.2. P.1 Scientific justification is required for Firm submitted the revised
using 3 preservatives in sterile single formulation in which they use only
dose injection, since the reference one preservative.
product approved in MHRA do not
use any preservative in their
formulation.
4. 3.2.P.8 Justify for not performing the sterility Firm replied that According to
test at the last time point of accelerated international guidelines (FDA) the
stability condition. sterility testing of a product is
performed on initial stage (first
time point) and terminal stage (last
time point) i.e at time point zero
and at 24th month stability studies.
We adopted the same guide line
and developed the SOP
accordingly.
Due to the previously mentioned
reason the sterility test was not
performed at the final time point i.e
6th month.
5. 2.3.R.1. Provide copy of Batch Manufacturing Submitted
1 Record (BMR) for all the batches of
drug product under section 2.3.R.1.1,
for which stability studies data is
provided in Module 3 section 3.2. P.8.
Decision: Approved. Firm shall submit revised formulation excluding preservatives as per
innovator product along with applicable fee for revision /correction of master formulation
no. as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
280. Name, address of Applicant / Marketing M/S Qadir Pharmaceuticals
Authorization Holder 6-Km G.T Road Wazirabad Sialkot
Pakistan.
Name, address of Manufacturing site. M/S Qadir Pharmaceuticals
6-Km G.T Road Wazirabad Sialkot
Pakistan.
☐ Importer
giver)
☐ Export sale
Aqua-Q 5ml Injection(WFI)
name
Strength / concentration of drug of Each filled ampule contains:
Active Pharmaceutical ingredient (API) Water for Injection……5mL
per unit
Pharmaceutical form of applied drug Solvent for Injection
Pharmacotherapeutic Group of (API) Solvent
BP Spec
specifications
The status in reference regulatory Manufacturer:
authorities Mercury pharmaceuticals
Address:Capital House,85King
Walliam StreetLondon EC4N7BL UK
For generic drugs (me-too status) Surge Labortories Pvt Ltd
manufacturer Tablet (General) ,Capsule (General), Capsule
(cephalosporin) Oral Dry Suspension
(cephalosporin) Oral liquid, liquid injectable
vial& Ampoule(Gerenal) Dry powder
Injectable(Gerenal) section approved.
Name and address of API manufacturer. M/S QADIR PHARMACEUTICALS
6-KM G.T Road Wazirabad Sialkot Pakistan
submitted.
Module III (Drug Substance) Official monograph of WFI is present in BP. The
impurity D, G & related substances (impurity A
& unspecified), specifications, analytical
months
months
Batches: (T001, T002, T003)
comparative dissolution profile established against the brand leader that is WFI
5 ml Injection manufacture by Global Pharma by
performing quality tests
Analytical method validation/verification NA

of product
Manufacturer of API M/S QADIR PHARMACEUTICALS
6-KM G.T Road Wazirabad Sialkot Pakistan
API Lot No. NA

Description of Pack
(Container closure Solvent for injection filled in glass ampoule Type 1 (1×1’s)
system)
Batch No. T-001 T-002 T-003
Batch Size 1000 Amp 1000 Amp 1000 Amp
No. of Batches 03
the firm (if any)
3. Documents for the procurement of API Submitted

import).

chromatograms,
sheets etc.
5. Compliance Record of HPLC software NA

testing
accelerated)
1. Provide detailed analytical procedures used for Submitted
the testing of drug substance (bulk water for
injection) since the submitted procedure only
reflect the acceptance limit.
2. Provide quantitative results in batch analysis Submitted
report of drug substance as per the decision of
293rd meeting of Registration Board, which
states that “For quantitative tests, actual
numerical results should be provided rather
than vague statements such as “within limits”
or “conforms”.
3. Provide detailed analytical procedure for Submitted
testing of pH
value,conductivity,endotoxin,sterility test,
liquid particulate matter ,sulfate, Aluminum
and ammonium.
4. Provide copy of Batch Manufacturing Record Submitted
(BMR) for all the batches of drug product under
section 2.3.R.1.1, for which stability studies
data is provided in Module 3 section 3.2. P.8.
Decision: Approved.
281. Name, address of Applicant / M/s Pasteur & Fleming Pharmaceuticals Pvt.
Marketing Authorization Holder Ltd. Industrial Estate Hattar.
Name, address of Manufacturing site. M/s Pasteur & Fleming Pharmaceuticals (Pvt).
Ltd. Plot No. 70-A, Road No. 04, Phase 3,
Industrial Estate. Hattar, Khyber Pakhtunkhwa
Pakistan
☐ Importer
giver)
☐ Export sale
Dy. No. and date of submission Dy. No.27898 dated 03/10/2022
Details of fee submitted PKR 30,000/-: dated. 04/08/2022. Slip No.
7108803872
PF-Zole 40mg Capsules
name
Strength / concentration of drug of Each Hard Gelatin Capsule contains:
Active Pharmaceutical ingredient (API) Esomeprazole Magnesium Trihydrate enteric
per unit coated pellets eq. to Esomeprazole…..... 40mg
(USP Specs)
Pharmaceutical form of applied drug White to off-white color EC Pellets filled in Hard
Gelatin Capsule Shell
USP
specifications
The status in reference regulatory Nexium 20mg Capsules by Astra Zeneca UK
authorities Limited 2 Pancras Square, 8th Floor, London,
N1C 4AG, UK USFDA Approved.
For generic drugs (me-too status) Esim 20mg Capsule by M/s Genome
Pharmaceuticals Reg. No. 053581
manufacturer Capsules (General) section approved.
Name and address of API manufacturer. Vision Pharmaceuticals (Pvt.) Limited
Plot No. 22-23, Industrial Triangle, Kahuta
Road, Islamabad- Pakistan
submitted.
Module III (Drug Substance) Official monograph of Esomeprazole
Magnesium is present in USP. The firm as
process and controls, , specifications, analytical
months
months
Batches # EMZ045859, EMZ045908,
EMZ045898
comparative dissolution profile established against the brand leader that is Esim
20mg Capsules by M/S Genome Pharma by
Dissolution, and Uniformity of dosage form).
that is 20mg Capsules by Genome Pharma in
Acid media (pH 1.0-1.2) & Phosphate Buffer (pH
acceptable range.
specificty.
Manufacturer of API Vision Pharmaceuticals (Pvt.) Limited
Plot No. 22-23, Industrial Triangle, Kahuta Road, Islamabad- Pakistan.
API Lot No. EMZ 046492
Description of Pack
system)
Batch Size 1000 Caps 1000 Caps 1000 Caps
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate Copy of GMP certificate No. F.3-26/2019-
of API manufacturer issued by Addl.Dir. (QA & LT-1) by DRAP valid till
concerned regulatory authority of 10/02/2022.
country of origin.
3. Documents for the procurement of API • Locally Purchased from Vision Pharma
with approval from DRAP (in case of Islamabad
import). • D.C # 802250 , dated 18/03/2022

sheets etc.
testing
accelerated)
. comings
1. Submit label claim in module 1 as per Firm submit the correct label claim of the
the reference product along with applied product without fee.
submission of requisite fee.
2. Submit data in section 3.2.S.4.3 as per Firm submitted only the summary tablet of
the guidance document approved by analytical verification report.
“Analytical Method Verification
manufacturer for both compendial as
well as non-compendial drug
substance(s) shall be submitted”
3. Justify the label claim without Firm submitted the revised formulation table in
mentioning the salt form of which the magnesium has not been adjusted in
esomeprazole while the pellets contain the filled weight of capsule and the magnesium
esomeprazole magnesium trihydrate. factor is 1.035.
Furthermore, also submit master
formulation keeping in view the salt
factor and percentage of pellets used in
the development of stability batches.
4. Justify why the pharmaceutical Firm replied that Now we are doing
equivalence and comparative Pharmaceuticals Equivalence & Comparative
dissolution profile studies were dissolution with Nexium 40mg Capsules &
conducted against the comparator Report summary will be provided soon because
product instead of using innovator / revised CDP Testing is being perform at HPLC
reference product. with Nexum Capsules 20mg Reg# 033891 &
remaining ongoing real time stability study
Dissolution tests will be shifted on HPLC as
per U.S.P while our Assay tests already
performed on HPLC Chromatograms &
Reports are Attached in dossier.
5. Justify for performance of dissolution Firm replied that remaining ongoing real time
test on UV when the USP monograph stability study Dissolution tests will be shifted
recommend HPLC method for on HPLC.
dissolution testing.
6. Submit verification report of analytical Firm submitted only the summary tablet of
method of the drug product in section analytical verification report.
3.2.P.5.3.
7. Justify, how the average weight of Correct BMR has been submitted by the firm
capsule with shell become 302mg, in which the weight of empty capsule is
when the average filled weight was 105mg.
234.2 mg and the empty capsule shell
weight was 1.03mg as per the submitted
BMR.
8. • Provide details that which lot Firm replied that, “We purchased 3.0 Kg
number of drug substance has been Esomeprazole Pellets from Vision
used in manufacturing of each batch Pharmaceuticals whole lot Batch #
of drug product. EMZ046452 was utilized for the 3 trial batches
• Provide Record of Digital data of PF-Zole 20mg & the three trial batches of
logger for temperature and humidity PF-Zole 40mg. Invoice & COA of raw material
monitoring of stability chambers is attached.”
9. Provide compliance Record of HPLC Firm replied that “We have used Shemadzu
software 21CFR & audit trail reports on HPLC there was a problem in the software of
product testing. the attached computer system due to this
problem the audit trail couldn’t be turned on
the whole process of stability study. Now we
purchased another Water Alliance CFR-21
Compliance HPLC with software backup.”
Decision: Approved.
• Manufacturer shall adopt the calculations for potency adjustment for commercial
manufacturing on basis of potency determined during drug substance anlaysis.
• Registration letter will be issued upon submission of analytical method verification
studies of drug product, performance of stability study at next time point of long term
stability studies as per USP monograph and CDP report in accordance with revised
analytical method based upon HPLC.
• Full fee of Rs. 30,000/-, for revision of data as per notification No.F.7-11/2012-
282. Name, address of Applicant / M/s Pasteur & Fleming Pharmaceuticals Pvt. Ltd.
Marketing Authorization Holder Industrial Estate Hattar.
Name, address of Manufacturing site. M/s Pasteur & Fleming Pharmaceuticals (Pvt).
Ltd. Plot No. 70-A, Road No. 04, Phase 3,
Industrial Estate. Hattar, Khyber Pakhtunkhwa
Pakistan
☐ Importer
Details of fee submitted PKR 30,000/-: dated. 04/08/2022. Slip No.
67351827467
PF-Zole 20mg Capsules
name
Strength / concentration of drug of Each Hard Gelatin Capsule contains:
Active Pharmaceutical ingredient Esomeprazole Magnesium Trihydrate enteric
(API) per unit coated pellets eq. to Esomeprazole….... 20mg
( USP Specs)
Pharmaceutical form of applied drug White to off-white color EC Pellets filled in Hard
Gelatin Capsule Shell
USP
specifications
The status in reference regulatory Nexium 20mg Capsules by Astra Zeneca UK
authorities Limited
2 Pancras Square, 8th Floor, London, N1C 4AG,
UK USFDA Approved.
For generic drugs (me-too status) Esim 20mg Capsule by M/s Genome
Pharmaceuticals Reg. No. 046196
manufacturer Capsules (General) section approved.
Name and address of API Vision Pharmaceuticals (Pvt.) Limited
manufacturer. Plot No. 22-23, Industrial Triangle, Kahuta Road,
Islamabad- Pakistan
Module III (Drug Substance) Official monograph of Esomeprazole Magnesium
is present in USP. The firm as submitted detail of
months
months
Batches # EMZ045058, EMZ0446320,
EMZ044858
comparative dissolution profile established against the brand leader that is Esim
20mg Capsules by M/S Genome Pharma by
that is 20mg Capsules by Genome Pharma in Acid
media (pH 1.0-1.2) & Phosphate Buffer (pH 6.8).
range.
specificity.
Manufacturer of API Vision Pharmaceuticals (Pvt.) Limited
Plot No. 22-23, Industrial Triangle, Kahuta Road, Islamabad- Pakistan.
API Lot No. EMZ 046492
Description of Pack
system)
Batch Size 1000 Caps 1000 Caps 1000 Caps
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate Copy of GMP certificate No. F.3-26/2019-
of API manufacturer issued by Addl.Dir. (QA & LT-1) by DRAP valid till
country of origin.
3. Documents for the procurement of API • Locally Purchased from Vision Pharma
with approval from DRAP (in case of Islamabad
import). • D.C # 802250 , dated 18/03/2022

sheets etc.
testing
accelerated)
. comings
1. Submit label claim in module 1 as per Firm submit the correct label claim of the
the reference product along with applied product without fee.
2. Submit data in section 3.2.S.4.3 as per Submitted only the summary table of
the guidance document approved by Module-2.
“Analytical Method Verification
manufacturer for both compendial as
well as non-compendial drug
substance(s) shall be submitted”
3. Justify the label claim without Firm submitted the revised formulation
mentioning the salt form of table in which the magnesium has not
esomeprazole while the pellets contain been adjusted in the filled weight of
esomeprazole magnesium trihydrate. capsule and the magnesium factor is
Furthermore, also submit master 1.035.
formulation keeping in view the salt
factor and percentage of pellets used in
the development of stability batches.
4. Justify why the pharmaceutical Firm replied that Now we are doing
equivalence and comparative Pharmaceuticals Equivalence &
dissolution profile studies were Comparative dissolution with Nexium
conducted against the comparator 40mg Capsules & Report summary will
product instead of using innovator / be provided soon because revised CDP
reference product. Testing is being perform at HPLC with
Nexum Capsules 20mg Reg# 033891 &
remaining ongoing real time stability
study Dissolution tests will be shifted on
HPLC as per U.S.P while our Assay tests
already performed on HPLC
Chromatograms & Reports are Attached
in dossier.
5. Justify for performance of dissolution Firm replied that remaining ongoing real
test on UV when the USP monograph time stability study Dissolution tests will
recommend HPLC method for be shifted on HPLC.
dissolution testing.
6. Submit verification report of analytical Submitted only the summary table of
method of the drug product in section Module-2.
3.2.P.5.3.
7. Justify, how the average weight of Correct BMR has been submitted by the
capsule with shell become 302mg, firm in which the weight of empty capsule
when the average filled weight was is 105mg.
234.2 mg and the empty capsule shell
weight was 1.03mg as per the submitted
BMR.
8. • Provide details that which lot Firm replied that, “We purchased 3.0 Kg
number of drug substance has been Esomeprazole Pellets from Vision
used in manufacturing of each batch Pharmaceuticals whole lot Batch #
of drug product. EMZ046452 was utilized for the 3 trial
• Provide Record of Digital data batches of PF-Zole 20mg & the three trial
logger for temperature and humidity batches of PF-Zole 40mg. Invoice &
monitoring of stability chambers COA of raw material is attached.”
9. Provide compliance Record of HPLC Firm replied that “We have used
software 21CFR & audit trail reports on Shemadzu HPLC there was a problem in
product testing. the software of the attached computer
system due to this problem the audit trail
couldn’t be turned on the whole process
of stability study. Now we purchased
another Water Alliance CFR-21
Compliance HPLC with software
backup.”
Decision: Approved.
• Manufacturer shall adopt the calculations for potency adjustment for commercial
manufacturing on basis of the content of “Esomeprazole” determined during drug
substance analysis.
• Registration Board further decided that registration letter will be issued upon submission
of following:
o Analytical verification studies of drug product in accordance with USP monograph.
o CDP studies performed by revised analytical method based upon HPLC.
o Performance of stability study at next time point of long term stability studies wherein
analysis shall be conducted as per USP monograph.
o Full fee of Rs. 30,000/-, for revision of data as per notification No.F.7-11/2012-
283. Name, address of Applicant / VARIANT PHARMACEUTICALS (PVT.)
Marketing Authorization Holder LTD
Name, address of Manufacturing site. PLOT # 5, M-2, PHARMAZONE, 26 KM MAIN
SHARAQPUR ROAD DISTRICT
SHEIKHUPURA.PAKISTAN
☐ Importer
giver)
☐ Export sale
V-MONT 05mg Tablet
name
Strength / concentration of drug of Each Chewable tablet contains Montelukast
Active Pharmaceutical ingredient Sodium eq. to Montelukast …..5mg
(API) per unit
Pharmaceutical form of applied drug Film coated tablet.
Pharmacotherapeutic Group of (API) Leukotriene antagonist
USP specifications
specifications
The status in reference regulatory SINGULAIR 5mg tablet by MERCK & CO.,
authorities INC, USFDA Approved.
For generic drugs (me-too status) BRONSECUR 5 mg tab by M/s Pfizer Pharma
(Pvt.) Ltd., Reg. No. 061335
manufacturer General Tablet, General Capsule, General Sachet
and General dry powder injectable (pre-
lyophilized)
Name and address of API manufacturer. Zhejiang Tianyu Pharmaceutical Co., Ltd.
Address: No.15, Donghai 5th Avenue, Zhejiang
Provincial Chemical and Medical Raw Materials
Base Linhai Zone, Taizhou City, Zhejiang
Province, China.
P.C.:317016
Module III (Drug Substance) Official monograph of Montelukast Sodium is
present in USP. The firm as submitted detail of
controls, tests for impurity & related substances,
substance
months
months
Batches:(201310301, 201310302,201310303)
comparative dissolution profile established against the reference product that is
Floaid 5mg Tablet by M/s. Highnoon Labs Ltd,
Reg.no. 032075 Batchno.212149, expiry date 07-
2023. by performing quality tests (Identification,
Assay, Dissolution,).
that is Floaid 5mg Tablet by M/s. Highnoon Labs
Ltd, Reg.no. 032075 Batchno.212149, expiry
date 07-2023, in Acid media (pH 1.2), Acetate
buffer (pH 4.5) & Phosphate Buffer (pH 6.8). The
values for f1 and f2 are in the acceptable range.
specificty.
Manufacturer of API Zhejiang Tianyu Pharmaceutical Co., Ltd.
Address: No.15, Donghai 5th Avenue, Zhejiang Provincial Chemical
and Medical Raw
Materials Base Linhai Zone, Taizhou City, Zhejiang Province, China.
P.C.:317016
API Lot No. 11001-200509
Description of Pack
system)
Batch No. T-001 T-002 T-003
No. of Batches 03
the firm (if any)
8. Approval of API/ DML/GMP certificate Copy of GMP certificate No. ZJ20180033 issued
of API manufacturer issued by by China FDA valid till 14-03-2023.
country of origin.
9. Documents for the procurement of API • Copy of letter No.4111/2020/DRAP-AD-
with approval from DRAP (in case CD(I&E) dated 02/03/2020 is submitted
of import). wherein the permission to import different
APIs including Montelukast Sodium for the
granted.
• Invoice # TYI2020704211 AD date 04-07-
2020
sheets etc.
testing
accelerated)
comings
1. 3.2.S.4.2: Analytical procedures Firm submitted the analytical procedure
Provide detailed analytical procedures and analytical verification report of drug
for the testing of drug substance by substance by drug product manufacturer.
3.2.S.4.3: Validation of analytical
procedures
Provide analytical Method validation
studies performed by the Drug Product
manufacturer.
2. Justify the use of a different analytical Firm submitted the analysis sheet in which
method for assay testing of drug the sample preparation method is in
product in terms of concentration of accordance with USP monograph of
sample solution and standard solution montelukast chewable tablet
from that specified in USP monograph.
Decision: Deferred for justification of using Montelukast sodium as reference standard in
analytical procedures instead of Montelukast dicyclohexylamine as specified by USP
monograph.
284. Name, address of Applicant / VARIANT PHARMACEUTICALS (PVT.) LTD
Name, address of Manufacturing site. PLOT # 5, M-2, PHARMAZONE, 26 KM MAIN
SHARAQPUR ROAD DISTRICT
SHEIKHUPURA.PAKISTAN
☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand V-MONT 04mg Sachet
name
Strength / concentration of drug of Each Sachet contains Montelukast Sodium eq. to
Active Pharmaceutical ingredient Montelukast …..4mg
(API) per unit
Pharmaceutical form of applied drug Sachet.
Pharmacotherapeutic Group of (API) Leukotriene antagonist
Reference to Finished product USP specifications
specifications
The status in reference regulatory Montelukast 4 mg Granules by TORRENT
authorities PHARMA (UK) Ltd, MHRA approved.
For generic drugs (me-too status) FLOAID 4mg Sachet by M/s Highnoon Labs
Ltd, Reg. No. 044768
manufacturer General Tablet, General Capsule, General
Sachet and General dry powder injectable (pre-
lyophilized)
Name and address of API Zhejiang Tianyu Pharmaceutical Co., Ltd.
manufacturer. Address: No.15, Donghai 5th Avenue, Zhejiang
Provincial Chemical and Medical Raw Materials
Base Linhai Zone, Taizhou City, Zhejiang
Province, China.
P.C.:317016
Module III (Drug Substance) Official monograph of Montelukast Sodium is
substance
months
months
Batches:(201310301, 201310302,201310303)
FLOAID 4mg Sachet by M/s Highnoon Labs Ltd,
Reg. No. 044768 by performing quality tests
(Identification, Assay, Dissolution,).
that is FLOAID 4mg Sachet by M/s Highnoon
Labs Ltd, in Acid media (pH 1.2), Acetate buffer
(pH 4.5) & Phosphate Buffer (pH 6.8). The values
specificity.
Manufacturer of API Zhejiang Tianyu Pharmaceutical Co., Ltd.
Address: No.15, Donghai 5th Avenue, Zhejiang Provincial Chemical
and Medical Raw
Materials Base Linhai Zone, Taizhou City, Zhejiang Province, China.
P.C.:317016
API Lot No. 11001-200509
Description of Pack
(Container closure Alu-Alu Sachet packed in unit carton
system)
Batch No. T-001 T-002 T-003
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate Copy of GMP certificate No. ZJ20180033 issued
of API manufacturer issued by by China FDA valid till 14-03-2023.
country of origin.
3. Documents for the procurement of API • Copy of letter No.4111/2020/DRAP-AD-
with approval from DRAP (in case CD(I&E) dated 02/03/2020 is submitted
of import). wherein the permission to import different
APIs including Montelukast Sodium for the
granted.
• Invoice # TYI2020704211 AD date 04-07-
2020
sheets etc.
testing
accelerated)
1. 3.2.S.4.2: Analytical procedures Firm submitted the analytical procedure
Provide detailed analytical procedures for and verification report of drug substance
the testing of drug substance by drug by drug product manufacturer.
3.2.S.4.3: Validation of analytical
procedures
Provide analytical Method validation
studies performed by the Drug Product
manufacturer.
Decision: Deferred for justification of using Montelukast sodium as reference standard in
analytical procedures instead of Montelukast dicyclohexylamine as specified by USP
monograph.
285. Name, address of Applicant / Marketing M/s Fortune Pharmaceuticals Private Limited
Authorization Holder Karachi
Name, address of Manufacturing site. M/s Fortune Pharmaceutical Private Limited
Plot K/201 S.I.T.E. (SHW) Phase II, Karachi,
Pakistan
☐ Importer
giver)
☐ Export sale
F -OMEZOL 20mg Gastro-resistance Capsule
name
Active Pharmaceutical ingredient (API) Omeprazole 22.5% Enteric coated pellets
per unit E.q to to Omeprazole 20mg
Pharmaceutical form of applied drug A Green cap with grey body size “3” hard
Gelatin filled capsule having white pallets.
Pharmacotherapeutic Group of (API) Drugs for acid-related disorders, Proton pump
inhibitors
USP
specifications
authorities Omeprazole 20mg Gastro – resistant capsule
MHRA
For generic drugs (me-too status) LOSEC CAPSUL 20 mg
BARRETT HODGSON PAKISTAN (PVT)
LTD
manufacturer Tablet, Capsule (General & General Antibiotic)
section approved.
Name and address of API manufacturer. SAAKH PHARMA.
Address: Plot # C -7/1, North West Industrial
Zone, Karachi
submitted.
Module III (Drug Substance) Official monograph of Omeprazole is present
in USP. The firm as submitted detail of
substance
months
months
Batches: (OME-EC – 22.5-001-19,
OME-EC – 22.5-008-19, OME -EC – 22.5-
009-19)
procedure (including dissolution testing at
acidic and buffer medium) and its verification
product.
LOSECCAPSULE 20 mg Capsule by
LTD.
brand that is LOSEC CAPSULE 20 mg by
LTD.
in Acid media (pH 1.2), pH 4.5& Phosphate
specificty.
Manufacturer of API SAAKH PHARMA.
Address: Plot # C -7/1, North West Industrial Zone,
API Lot No. 22GT2 2002
Description of Pack
system)
Batch No. FE-001 FE-002 FE-003
Batch Size 1400 capsule 1400 capsule 1400 capsule
No. of Batches 03
applications with stability study data of Because of new DML
the firm (if any)
2. Approval of API/ DML/GMP certificate GMP Certificate No. 83/2020-DRAP(K) dated
of API manufacturer issued by 23-06-2022
country of origin.
3. Documents for the procurement of API Local purchase from M/s. Saakh
with approval from DRAP (in case of Pharma,Karachi
import).
sheets etc.
5. Compliance Record of HPLC software HPLC software 21CFR not Installed
testing
accelerated)
Sr.n Observations/Shortcomings Reply of the Form
o.
1. Justify how you claim USP specification Firm submitted the specification of drug
for drug substance, when the submitted substance by drug substance
analytical method is not in accordance manufacturer which is also not
with USP neither similar to the assay incompliance of USP monograph.
method of drug substance manufacturer.
Further, the assay method given in section
3.2. S. 4.2 is different from the method
which is validated in section 3.2.S.4.3,
clarification is required in this regard.
2. Clarification is required regarding the Firm submitted the stability data sheet of
assay results of stability data of drug drug substance in which assay results are
substance, either the quantity is of dried specified on dried basis, while in USP
basis of omeprazole magnesium or the monograph the content of active should
labelled amount of omeprazole, since the be quantify on the basis of labelled
COA of drug substance claim the content amount of omeprazole. Further the
of active on dried basis. dissolution result of acidic stage has not
been included in the stability data sheet
of the drug substance.
3. Provide complete method of dissolution Firm has not submitted the reply in
testing along with details of HPLC response of this query.
parameters used during the dissolution
testing of drug product in line with USP.
4. Provide complete analytical method Firm has not submitted the analytical
verification studies of drug product verification report of drug product.
including the specificity and repeatability
parameter along with raw data sheets and
chromatogram.
5. Performance of comparative dissolution Firm submitted the revised Comparative
profile is not in accordance with dissolution profile data in which all 12
guidelines approved in 293rd meeting of units of both test product and reference
Registration Board with reference to shows below 65% release in pH 6.8
following points: medium till 45 minutes while the
✓ For f2 calculations a minimum of dissolution results of stability data
three time points (excluding point reveals that more than 90% drug release
zero) must be used; mentioned the at pH 6.8 medium within 30 minutes.
time point which were considered
for the calculation of f2 value.
✓ A maximum of one time-point
should be considered after 85%
dissolution of the innovator /
reference product has been
reached; but as per the submitted
documents you have used all time
point until 30minutes, which are
all below 85%. Clarify how you
have calculated the f2 without
considering the time point after
85% drug release.
6. Clarify, why you have not mentioned the Firm has submitted the revised stability
results of dissolution test in acidic data in which results of assay of
medium in the stability data of drug esomeprazole has been mentioned
product. Further, the specification of instead of omeprazole.
dissolution test did not mention the time
limit in which NLT 75% (Q) should be
achieved.
• Justify how you claim USP specification for drug substance, when the submitted analytical
method is not in accordance with USP neither similar to the assay method of drug
substance manufacturer. Further, the assay method given in section 3.2. S. 4.2 is different
from the method which is validated in section 3.2.S.4.3, clarification is required in this
regard.
• Stability data sheet of drug substance including the results of dissolution test of acidic
stage.
• Provide complete method of dissolution testing along with details of HPLC parameters
used during the dissolution testing of drug product in line with USP.
• Provide complete analytical method verification studies of drug product including the
specificity and repeatability parameter along with raw data sheets and chromatogram.
• Justify the dissolution results of stability data in which more than 90% drug release at pH
6.8 medium within 30 minutes, while the revised Comparative dissolution profile data
evident that both test product and reference product release below 65% in pH 6.8 medium
till 45 minutes.
• Revised stability data of drug product specify the results of assay of esomeprazole,
Pakistan
☐ Importer
giver)
☐ Export sale
F -OMEZOL 40mg Gastro-resistance Capsule
name
Active Pharmaceutical ingredient (API) Omeprazole 22.5% Enteric coated pellets
per unit E.q to to Omeprazole 40mg
Pharmaceutical form of applied drug A Green cap with grey body size “3” hard
inhibitors
USP
specifications
authorities Omeprazole 40mg Gastro – resistant capsule
MHRA
For generic drugs (me-too status) LOSEC CAPSUL 40 mg
LTD
section approved.
Zone,
submitted.
Module III (Drug Substance) Official monograph of Omeprazole is present
substance
months
months
Batches: (OME-EC – 22.5-001-19,
OME-EC – 22.5-008-19, OME -EC – 22.5-
009-19)
product.
LOSEC CAPSULE 40 mg Capsule by
LTD.
that is LOSEC CAPSULE 40 mg by
LTD in all three physiological mediums. The
specificty.
Description of Pack
system)
No. of Batches 03
the firm (if any)
country of origin.
3. Documents for the procurement of API Local purchase from M/s. Saakh Pharma,
with approval from DRAP (in case of Karachi
import).
sheets etc.

testing
accelerated)
Sr.n Observations/Shortcomings Reply of the Form
o.
with USP neither similar to the assay incompliance of USP monograph.
method of drug substance manufacturer.
substance, either the quantity is of dried specified on dried basis, while in USP
basis of omeprazole magnesium or the monograph the content of active should
labelled amount of omeprazole, since the be quantify on the basis of labelled
COA of drug substance claim the content amount of omeprazole. Further the
of active on dried basis. dissolution result of acidic stage has not
been included in the stability data sheet
of the drug substance.
3. Provide complete method of dissolution Firm has not submitted the reply in
testing along with details of HPLC response of this query.
verification studies of drug product verification report of drug product.
including the specificity and repeatability
chromatogram.
✓ For f2 calculations a minimum of dissolution results of stability data
three time points (excluding point reveals that more than 90% drug release
zero) must be used; mentioned the at pH 6.8 medium within 30 minutes.
time point which were considered
for the calculation of f2 value.
✓ A maximum of one time-point
should be considered after 85%
dissolution of the innovator /
reference product has been
reached; but as per the submitted
documents you have used all time
point until 30minutes, which are
all below 85%. Clarify how you
have calculated the f2 without
considering the time point after
85% drug release.
results of dissolution test in acidic data in which results of assay of
medium in the stability data of drug esomeprazole has been mentioned
product. Further, the specification of instead of omeprazole.
achieved.
regard.
stage.
• Provide complete method of dissolution testing along with details of HPLC parameters
used during the dissolution testing of drug product in line with USP.
till 45 minutes.
• Revised stability data of drug product specify the results of assay of esomeprazole,
Pakistan
☐ Importer
giver)
☐ Export sale
F -EZOLE 40mg Gastro resistant Capsule
name
Active Pharmaceutical ingredient (API) Esomeperazole Magnisium Trihydrate
per unit E.q to to Esomeperazole 40mg
Pharmaceutical form of applied drug A dark blue cap with blue body size “3” hard
inhibitors
USP
specifications
The status in reference regulatory NEXIUM 40mg Capsule USFDA.
authorities Esomeprazole 40mg Gastro – resistant capsule
MHRA
For generic drugs (me-too status) ACIREG CAPSUL 40 mg
LTD
section approved.
Zone,Karachi
submitted.
Module III (Drug Substance) Official monograph of Esomeprazole Mg is
substance
months
months
Batches: (ESO-EC – 22.5-001-19,
ESO-EC – 22.5-002-19, ESO-EC – 22.5-003-
19)
product.
ACIREG CAPSULE 40 mg Capsule by
LTD.
that is ACIREG CAPSULE 40 mg by
LTD.in Acid media (pH 1.2), pH 4.5 &
Phosphate Buffer (pH 6.8). The values for f1 and
specificty.
Description of Pack
system)
No. of Batches 03
the firm (if any)
country of origin.
3. Documents for the procurement of API Local purchase from M/s. Saakh Pharma,
with approval from DRAP (in case of Karachi
import).
sheets etc.
testing
accelerated)
Sr.no Observations/Shortcomings Reply of the Form
.
with USP neither similar to the assay incompliance of USP monograph with
method of drug substance manufacturer. reference to the assay results.
2. Provide COA of primary / secondary Firm submitted the COA of working
reference standard including source and standard of Esomeprazole, while the
lot number used for testing of drug USP recommends Omeprazole RS for
substance. the assay testing of Esomeprazole
delayed release capsule.
substance, either the quantity is of dried specified on anhydrous basis, while in
basis of omeprazole magnesium or the USP monograph the content of active
labelled amount of omeprazole, since the should be quantify on the basis of
COA of drug substance claim the content labelled amount of Esomeprazole.
of active on dried basis. Further the dissolution result of acidic
stage has not been included in the
stability data sheet of the drug substance.
4. Provide complete method of dissolution Firm has submitted the reply in response
testing along with details of HPLC of this query.
verification studies of drug product verification report of drug product
including the specificity and repeatability neither the drug substance.
chromatogram.
✓ For f2 calculations a minimum of three dissolution results of stability data
time points (excluding point zero) must reveals that more than 90% drug release
be used; mentioned the time point at pH 6.8 medium within 30 minutes.
which were considered for the
calculation of f2 value.
✓ A maximum of one time-point should
be considered after 85% dissolution of
the innovator / reference product has
been reached; but as per the submitted
documents you have used all time point
until 30minutes, which are all below
85%. Clarify how you have calculated
the f2 without considering the time
point after 85% drug release.
results of dissolution test in acidic data in which more than 90% drug
medium in the stability data of drug release at buffer stage within 30 minutes.
product. Further, the specification of
achieved.
8. Raw data sheets of dissolution testing and assay testing have not been attached in
section 3.2. P.8., provide raw data sheet to analyse the result of dissolution and assay.
Firm has submitted the raw data sheets and chromatograms of dissolution and assay
testing, which evident that the assay was not performed in comply with USP
specification in term of sample and standard solution conc and the total run time
which is consist of 25 minutes’ gradient elution program. Further, the chromatogram
of standard evident that the esomeprazole has been used as a standard, while USP
monograph recommends omeprazole RS for the Esomeprazole capsule.
testing.
regard.
• Scientific justification for use of Esomeprazole as reference standard in analytical
procedures instead of Omeprazole RS as specified by USP monograph.
stage.
till 45 minutes.
• Scientific justification for using assay method different from that specified in USP
monograph in term of gradient program, total run time and reference standard.
Pakistan
☐ Importer
giver)
☐ Export sale
Fungazole 150mg Capsule
name
Active Pharmaceutical ingredient (API) Fluconazole...150mg
per unit
Pharmaceutical form of applied drug A dark blue cap with blue body size “3” hard
Pharmacotherapeutic Group of (API) Antifungal
BP
specifications
MHRA approved
authorities
For generic drugs (me-too status) Zolanix 150mg capsule of M/s. Glaxo
smithkline,Karachi
approved.
Name and address of API manufacturer. Hema Pharmaceuticals Plot no.6201/A&B Opp.
Ewac Alloys Ltd. GIDC
Ankleshwar,Gujrat,India
submitted.
Module III (Drug Substance) Official monograph of Fluconazole is present in
substance
months
months
Batches:
(12PDFC001,12PDFC002,12PDFC003)
product.
comparative dissolution profile established against the comparator product that
is Flozex capsule of M/S. Martin Dow
Pharmaceuticals Pvt. Ltd,Karachi Batch no. 225
expiry date 03-2023.
that is Flozex capsule of M/S. Martin Dow
Pharmaceuticals Pvt. Ltd,Karachi Batch no. 225
expiry date 03-2023.in Acid media (pH 1.2), pH
4.5 & Phosphate Buffer (pH 6.8). The values for
specificty.
Manufacturer of API Hema Pharmaceuticals Plot no.6201/A&B Opp. Ewac Alloys Ltd.
GIDC Ankleshwar,Gujrat,India
API Lot No. Not mentioned
Description of Pack
system)
Batch No. FL-001 FL-002 FL-003
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate GMP Certificate No. S-GMP/2062028 dated 12-
of API manufacturer issued by concerned 06-2020 valid till 11/06/2022
3. Documents for the procurement of API Consignment slip and DHL courier slip has been
with approval from DRAP (in case of attached only
import).
sheets etc.
testing
accelerated)
Sr.no Observations/Shortcomings Reply of the Form
.
1. Clarify the specification of drug Firm submitted the revised specification of drug
product since the JP monograph of product which is neither in comply of BP
fluconazole capsule is not applicable monograph nor in compliance of JP.
for 150mg strength. Revise your
specification along with the requisite
fee.
2. The validation of analytical Not submitted
procedure has been performed using
assay method (HPLC) with flow rate
1.0ml/min, column temperature
35°C, UV detector set at 261nm and
mobile phase sodium acetate:
methanol: acetonitrile while USP
recommended flow rate 0.5ml/min,
column temperature 40°C, UV
detector 260nm and mobile phase
Acetonitrile and water (20:80).
Justify, how have comply USP
specification by keeping the
chromatographic condition different
from USP monograph of fluconazole.
3. Clarify, how you have performed Not submitted any reply of this query
accuracy parameter in the
verification studies of drug substance
that, despite spiking the sample
25%,50%,75%,100%,125% and
150%, the amount of fluconazole has
not been changed in all these spiked
sample.
4. Identification test specified on the .Not submitted any reply of this query
COA of working standard of
fluconazole attached in section
3.2.S.5 stated that IR absorption
spectrum of test solution should be
concordant with that of clotrimazole
working standard, clarification is
required in this regard. Further, the
COA reflect that batch qualified
against Indian pharmacopeia
reference standard, justify how you
can standardize the drug substance
that comply with USP specification
to the working standard that qualified
against Indian pharmacopeia.
5. Scientific justification is required for Firm has not submitted any reply.
using 3mg overage of active
substance as evident from the
composition given in section 3.2. P.1.
6. Clarify, that the dissolution method Firm submitted the revised Comparative
given in section 3.2.P.5.2 is different dissolution profile in which the dissolution were
from the method via which not in accordance with BP monograph.
dissolution has been performed in
section 3.2.P.2.2.1 for comparative
dissolution profile of drug product.
7. • Justify selection of dissolution Firm has not submitted any justification
parameters i.e. USP apparatus-II regarding these queries.
paddle with 50rpm, water as
dissolution medium and
acceptance criteria NLT 75% of
the labeled amount of the claim
content, since JP monograph of
fluconazole capsule is
recommending the dissolution
testing for 50mg and 100mg
fluconazole capsule strength.
• Justify the variation in dissolution
parameters in different section of
dossier, acceptance limit specified
in section 3.2.P.5.2 is NLT 75% in
45 minutes while the dissolution
specifications mentioned on batch
analysis report is NLT 80%.
8. Provide complete analytical method Not submitted.
verification studies of drug product
including the specificity and
repeatability parameter along with
raw data sheets and chromatogram.
9. Justify the weight of sample between Not submitted
33-34mg, while as per the analytical
method given in section 3.2.P.5.2 the
weight of content equivalent to 50mg
of fluconazole should be taken
initially for preparation of final
dilution of sample solution.
10. Provide COA of primary / secondary Not submitted
and lot number used for testing of
drug product.
11. Compliance Record of HPLC Not submitted
on product testing.
• Clarify the specification of drug product since the JP monograph of fluconazole capsule
is not applicable for 150mg strength. Revise your specification along with the requisite
fee.
• The validation of analytical procedure has been performed using assay method (HPLC)
with flow rate 1.0ml/min, column temperature 35°C, UV detector set at 261nm and mobile
phase sodium acetate: methanol: acetonitrile while USP recommended flow rate
0.5ml/min, column temperature 40°C, UV detector 260nm and mobile phase Acetonitrile
and water (20:80). Justify, how have comply USP specification by keeping the
chromatographic condition different from USP monograph of fluconazole.
• Clarify, how you have performed accuracy parameter in the verification studies of drug
substance that, despite spiking the sample 25%,50%,75%,100%,125% and 150%, the
amount of fluconazole has not been changed in all these spiked sample.
• Identification test specified on the COA of working standard of fluconazole attached in
section 3.2.S.5 stated that IR absorption spectrum of test solution should be concordant
with that of clotrimazole working standard, clarification is required in this regard.
Further, the COA reflect that batch qualified against Indian pharmacopeia reference
standard, justify how you can standardize the drug substance that comply with USP
specification to the working standard that qualified against Indian pharmacopeia.
• Justify, for adopting the dissolution parameter specified in JP monograph, since the JP
monograph recommends the acceptance limits for 50mg and 100g fluconazole strength.
• Provide COA of primary / secondary reference standard including source and lot number
used for testing of drug product.
Previously Deferred Cases of Form 5-F:

289. Name, address of Applicant / M/s Himmel Pharmaceuticals (Pvt.) Ltd.
Importer 793-D, Block ‘’C’’, Faisal Town Lahore.
Details of Drug Sale License of License No: 05-352-0065-016174-D
importer Address: 793-D, Block-C, Faisal Town Lahore
Address of Godown: NA Validity: 06. Feb.2022
Name and address of marketing M/s BEACON Pharmaceuticals Limited
authorization holder (abroad) Plant address: Kathali, Bhaluka, Mymensingh
Bangladesh
Name, address of manufacturer(s) M/s BEACON Pharmaceuticals Limited
Bangladesh
Detail of certificates attached (CoPP, CoPP: Original legalized COPP (Certificate# DA/6-
Free sale certificate, GMP 110/2016/3300 issued on 01-06-2020 by
certificate) Government of the people’s republic of Bangladesh,
Ministry of Health & Family welfare, Directorate
General of Drug Administration, Oushad Bhaban,
Mohkhali Dhaka-1212, Bangladesh.
Also, Renewal certificate is submitted (Certificate
No. DA/6-110/06/4950).
Details of letter of authorization / Firm has submitted copy of letter of distribution
sole agency agreement certificate from Beacon Pharmaceuticals limited.
their products in Pakistan. The authorization letter is
valid till June, 2025.
☒ Importer
For imported products, specify one ☒ Finished Pharmaceutical product import
the these ☐ Buk import and local repackaging
purpose only
Dy. No. and date of submission Dy. No.16561 Date:15.06.2021
Details of fee submitted PKR: 100,030/- Date: Dec-2020
The proposed proprietary name / Pazonix 200mg Tablet
brand name
Strength / concentration of drug of Each tablet contains
Active Pharmaceutical ingredient Pazopanib Hydrochloride INN….200mg
(API) per unit
Reference to Finished product In house
specifications
Proposed Pack size 30’s (HDPE Bottle)
The status in reference regulatory Votrient 200mg Tablet
authorities
For generic drugs (me-too status) Votrient (Novartis)
Summary) template. Firm has summarized information related
Name, address of drug substance Ace bright (India) Pharma Private Limited
manufacturer Address: No. 77D &116/117, KIADB Industrial
Area Jigani, Bangalore - 560 105
Karnataka, India.
Stability Studies of Drug Substance Firm has submitted long term stability study data of
(Conditions & duration of Stability 3 batches of drug substance at 25°C ± 2°C / 60 ± 5%
studies) RH for 12 months. The accelerated stability data is
conducted at 40°C ± 2°C / 75 ± 5% RH for 6 months
Pharmaceutical Equivalence and Comparative analysis Studies against the reference
Comparative Dissolution Profile product Votrient 200mg (Novartis) has been
submitted
Container closure system of the drug HDPE Bottle
product
Stability study data of drug product, Firm has submitted stability study data of 3 batches.
shelf life and storage conditions Accelerated stability studies have been conducted at
40oC±2oC and 75%±5% RH for 6 months.
Evaluation by PEC:
Sr. Shortcomings/Deficiencies Response of the Firm
no.
1. Submit data of analytical Method Firm has submitted analytical method validation
verification studies including studies of drug substance performed by drug
specificity, accuracy and product manufacturer.
repeatability (method precision).
2. Justify acceptance criteria set for Firm has submitted the reply, in which it is stated
dissolution test i.e. NLT 70% (Q) in that “The dissolution time for pazonix 200mg tablet
60 minutes, which is not as per the has been selected 60 minutes as per the FDA
international guidelines as well as dissolution database. In the database, USP
the decision of Registration Board apparatus Type-II and 10,20,30,45 and 50 min has
i.e. “For all type of drug products, been mentioned for profiling. For the immediate
the value of “Q” should not be less release tablet, we have selected 60 mins as a single
than 75% in any case as per the time point.
recommendations of United States Firm has not given any scientific justification for
Pharmacopoeia (USP) General selecting the extreme time point i.e. 60 minutes for
Chapter <711> Dissolution, dissolution of drug product, while the FDA review
Dissolution testing in BP finished document of innovator product reveals that the
products monographs for solid oral dissolution criteria should be Q= at 30 minutes
dosage forms and The International using the following conditions. Apparatus: USP
Pharmacopoeia Ninth Edition, 2019 Apparatus 2 Volume: 900 mL Medium: 50 mM
-Dissolution testing of tablets and sodium acetate buffer, pH 4.5, containing 0.75%
capsules”. SDS Agitation: Paddle speed of 75 rpm. Analysis:
As per the submitted data percentage UV at 270 nm with a background correction at 400
of drug release at 30 minutes was nm. Temperature: 37°C.
55.09% in the USFDA
recommended release media.
Justify, how your formulation can be
considered equivalent to the
innovator product which shows
release more than Q+5% in 30
minutes.
3. • Justify how the results of all Firm has not provided any justification regarding
quality tests for every batch in these queries, instead submit the stability data of
stability studies are same at all commercial batches. (batch no.
time points. 3860005,3860006,3860007)
• Justification is required
regarding the out of specification
assay results i.e. 46.5mg content
of pazopanib per tablet at 6-
month time interval during the
accelerated stability studies of
batch no. 3860003 and 3860004.
4. Provide copy of Batch Firm has submitted the Batch Manufacturing
Manufacturing Record (BMR) for Record of batch no. 3860002, 3860003 and
all the batches of drug product under 3860004.
section 2.3.R.1.1, for which stability
studies data is provided in Module 3
section 3.2. P.8.
5. Firm has submitted the differential fee of Rs. 50,000 vide Challan no.78134245317 dated
22-08-2022 for finished import drug product, as per notification No.F.7-11/2021-
Decision of M-321:
Deferred for Scientific justification regarding difference in dissolution limits in terms of %age
released and time point from that recommended by the US FDA for innovator product.
Firm revised the Dissolution parameters as per the recommendation of USFDA approved innovator
product, however the submitted document did not clarify the percentage release which should be
achieved at 30 minutes.
Decision: Deferred for submission of dissolution test in compliance to revised dissolution
parameters as per innovator drug product.
290. Name, address of Applicant / M/s Hiranis Pharmaceuticals (Pvt.) Ltd
Name, address of Manufacturing site. M/s Hirais Pharmaceuticals (Pvt.) Ltd
Plot E-145-149, North western industrial zone, Port
Qasim, Karachi.
☐ Importer

Parofen 150/500mg Tablet
brand name
Active Pharmaceutical ingredient Ibuprofen 150mg + Paracetamol 500mg
(API) per unit
Pharmacotherapeutic Group of (API) Analgesics and antipyretics
Manufacturer’s Spec.
specifications
The status in reference regulatory MHRA, TGA Australia
authorities Tachifene Tablet
M/s Angelini Pharma
Italian Medicine Agency approved.
For generic drugs (me-too status) Provas Duo Tablet 500/150 of M/s. Sami
Pharmaceuticals, Karachi Reg.no.108837
GMP status of the Finished product DML by way of formulation No. 000785 dated 03-
manufacturer 02-2019
Name and address of API Ibuprofen
manufacturer. M/s Hubei BiocauseHeilen Pharmaceutical Co.,
Ltd
Address꞉122 Yangwan Road, Jingmen City, Hubei
Province 448000, People’s Republic of China
Paracetamol
M/s Zafa Chemie
Address꞉ Raiwind Manga Bypass, Near Sundar
Industrial Estate, Mouza Bhaikot, Tehsil & District
Lahore.
Module III (Drug Substance) Ibuprofen:
Official monograph is present in United States
pharmacopeia. The firm has submitted detail of
Paracetamol:
Official monograph is present in British
Ibuprofen:
months
months
Batches:
C100-1507197M, C100-1507198M & C100-
1507199M
Paracetamol:
months
months
Batches:
1331, 1332 & 1333
drug product.
comparative dissolution profile against the brand leader that is Tachifene Tablet by
M/s Angelini Francesco S.p.A (Lot no.021) by
is Tachifene Tablet by M/s Angelini Pharma in Acid
media (0.1 N HCL) & Acetate Buffer (pH 4.5) &
For Ibuprofen:
•It was found that both reference & test product
shows low solubility in 0.1N HCl but resemblance
in dissolution profile, the similarity factor, f2 is 93
which is greater than 50 & the difference factor f1 is
6 which is less than 15.
show low solubility in acetate Buffer pH 4.5 but
resemblance in dissolution profile, the profile
similarity factor, f2 is 93 which is greater than 50 &
the difference factor f1 is 4 which is less than 15.
show greater than 85% dissolution within 15
minutes in Phosphate Buffer pH 6.8, therefore they
are considered as similar & f2 value calculation is
not applicable.
For Paracetamol:
• It was found that both reference & test product
shows 85% dissolution within 15 minutes in 0.1N
HCl shows resemblance in dissolution profile, the
profile similarity factor, f2 value calculation is not
applicable.
shows greater than 85% dissolution within 15
minutes in acetate Buffer pH 4.5, therefore they are
considered as similar & f2 value calculation is not
applicable.
show 85% dissolution within 15 minutes in
Phosphate Buffer pH 6.8 shows resemblance in
dissolution profile, therefore they are considered as
similar & f2 value calculation is not applicable.
Manufacturer of API Ibuprofen
M/s Hubei Biocause Heilen Pharmaceutical Co., Ltd
Address꞉122 Yangwan Road, Jingmen City, Hubei Province 448000,
People’s Republic of China
Paracetamol
M/s Zafa Chemie
Address꞉ Raiwind Manga Bypass, Near Sundar Industrial Estate, Mouza
Bhaikot, Tehsil & District Lahore.
API Lot No. Ibuprofen
C100-1711278M
Paracetamol
6019
Description of Pack
Alu-PVC blister packed in unit carton (3×10’s)
(Container closure
system)
Batch No. TF-020520 TF-030520 TF-040520
No. of Batches 03
1. Reference of previous approval of Etoxib 90mg Tablet
applications with stability study data Etoxib 120mg Tablet
of the firm (if any) Approved in 294th minutes of meeting of DRB
2. Approval of API/ DML/GMP Ibuprofen:
certificate of API manufacturer issued Copy of GMP certificate No. HB20170363 issued
by concerned regulatory authority of by China Food and Drug Administration valid till
country of origin. 28/08/2022.
Paracetamol:
Copy of DML certificate No. 000589 issued by
Drug Regulatory Authority of Pakistan valid till
02/10/2019*.
(*Request for DML audit has already been
submitted by M/s Zafa Chemie, DRAP against this
letter has also instructed the concerned authority for
conduct of timely audit of M/s Zafa Chemie via
letter no. F.1-1/2006-Lic (Vol-II) dtd. 29-09-2021,
copy of the same attached for reference in dossier).
3. Documents for the procurement of Attested invoice from ADC attached for Ibuprofen
API with approval from DRAP (in Invoice No. W180316-035
case of import).
Attested invoice from ADC attached for
Paracetamol
documents like chromatograms, Submitted
sheets etc.
on product testing
accelerated)
no. comings
1. Justify the dissolution parameter of Firm replied that they adopted following dissolution
applied drug product with reference condition and acceptance criteria
to dissolution medium, acceptance Proposed Dissolution conditions:
criteria and other dissolution 1. Dissolution Test parameter (Paracetamol): i.
conditions, considering the USP Apparatus: Paddle ii. Dissolution medium:
general chapter <1092> and review Phosphate buffer pH 5.8 iii. Medium
report of innovator product. volume: 900ml iv. RPM: 50 v. Time: 30
minutes vi. Temperature: 37°C vii.
Acceptance Criteria: NLT 80% (Q) 2.
Dissolution Test parameter
2. (Ibuprofen): i. Apparatus: Paddle ii.
Dissolution medium: Phosphate buffer pH
7.2 iii. Medium volume: 900ml iv. RPM: 50
v. Time: 30 minutes vi. Temperature: 37°C
vii. Acceptance Criteria: NLT 80% (Q)
considering the guidance document: 1. USP chapter
1092 2. FDA guidance document for Dissolution
Testing and Acceptance Criteria for Immediate-
Release Solid Oral Dosage Form Drug Products
Containing High Solubility Drug Substances
(August 2018) 3. DRB Minutes of 293rd Meeting of
Registration Board (6 – 8th January, 2020) 4.
Pharmaceutical equivalence study with reference
product. 5. CDP study with reference product. 6.
Innovator review report (Nuromol tablet
200/500mg Reckitt Benckisar Healthcare, MHRA)
7. USP monograph of acetaminophen tablet.
2. Provide details that which lot Submitted
number of drug substance has been
used in manufacturing of each batch
of drug product. Also provide
documents confirming evidence of
import of each lot of drug substance
used in manufacturing of these
batches of drug product.
Decision: Approvedwith innovator’s specifications. Registration letter will be issued upon
submission of performance of dissolution test as per dissolution parameters by USFDA in the
literature review of innovator alongwith fee of RS. 7,500/- for revision/correction of drug
product specifcations as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
291. Name, address of Applicant / M/s Hiranis Pharmaceuticals (Pvt.) Ltd
Name, address of Manufacturing site. M/s Hiranis Pharmaceuticals (Pvt.) Ltd
Plot E-145-149, North western industrial zone, Port
Qasim, Karachi.
☐ Importer


Parofen Rapid Tablet
brand name
Active Pharmaceutical ingredient Ibuprofen 200mg + Paracetamol 500mg
(API) per unit
Manufacturer’s Spec.
specifications
The status in reference regulatory Nuromol Tablet
authorities M/s Reckitt Benckiser Pharma
MHRA approved.
GMP status of the Finished product DML by way of formulation No. 000785 dated 03-
manufacturer 02-2019
Name and address of API Ibuprofen
manufacturer. M/s Hubei Biocause Heilen Pharmaceutical Co.,
Ltd
Address꞉122 Yangwan Road, Jingmen City, Hubei
Province 448000, People’s Republic of China
Paracetamol
M/s Zafa Chemie
Address꞉ Raiwind Manga Bypass, Near Sundar
Industrial Estate, Mouza Bhaikot, Tehsil & District
Lahore.
Module III (Drug Substance) Ibuprofen:
Official monograph is present in United States
Paracetamol:
Official monograph is present in British
Ibuprofen:
months
months
Batches:
C100-1507197M, C100-1507198M & C100-
1507199M
Paracetamol:
months
months
Batches:
1331, 1332 & 1333

drug product.
comparative dissolution profile against the brand leader that is Neuromol Tablet of
M/s. Reckitt & Benckiser Sydney NSW, Australia
is Neuromol Tablet of M/s. Reckitt & Benckiser
Sydney NSW, Australia in Acid media (0.1 N HCL)
& Acetate Buffer (pH 4.5) & Phosphate Buffer (pH
6.8).
For Ibuprofen:
shows low solubility in 0.1N HCl but resemblance
in dissolution profile, the similarity factor, f2 is 93
which is greater than 50 & the difference factor f1 is
6 which is less than 15.
shows low solubility in acetate Buffer pH 4.5 but
resemblance in dissolution profile, the profile
similarity factor, f2 is 93 which is greater than 50 &
the difference factor f1 is 4 which is less than 15.
shows greater than 85% dissolution within 15
minutes in Phosphate Buffer pH 6.8, therefore they
are considered as similar & f2 value calculation is
not applicable.
For Paracetamol:
show 85% dissolution within 15 minutes in 0.1N
HCl shows resemblance in dissolution profile, the
profile similarity factor, f2 value calculation is not
applicable.
show greater than 85% dissolution within 15
minutes in acetate Buffer pH 4.5, therefore they are
considered as similar & f2 value calculation is not
applicable.
show 85% dissolution within 15 minutes in
Phosphate Buffer pH 6.8 shows resemblance in
dissolution profile, therefore they are considered as
similar & f2 value calculation is not applicable.

Manufacturer of API Ibuprofen
M/s Hubei Biocause Heilen Pharmaceutical Co., Ltd
Address꞉122 Yangwan Road, Jingmen City, Hubei Province 448000,
People’s Republic of China
Paracetamol
M/s Zafa Chemie
Address꞉ Raiwind Manga Bypass, Near Sundar Industrial Estate, Mouza
Bhaikot, Tehsil & District Lahore.
API Lot No. Ibuprofen
C100-1711278M
Paracetamol
6019
Description of Pack
(Container closure Alu-PVC blister packed in unit carton (3×10’s)
system)
Batch No. TF-050520 TF-060520 TF-080520
No. of Batches 03
1. Reference of previous approval of Etoxib 90mg Tablet
applications with stability study data Etoxib 120mg Tablet
of the firm (if any) Approved in 294th minutes of meeting of DRB
2. Approval of API/ DML/GMP Ibuprofen:
certificate of API manufacturer issued Copy of GMP certificate No. HB20170363 issued
by concerned regulatory authority of by China Food and Drug Administration valid till
country of origin. 28/08/2022.
Paracetamol:
Copy of DML certificate No. 000589 issued by
Drug Regulatory Authority of Pakistan valid till
02/10/2019*.
(*Request for DML audit has already been
submitted by M/s Zafa Chemie, DRAP against this
letter has also instructed the concerned authority for
conduct of timely audit of M/s Zafa Chemie via
letter no. F.1-1/2006-Lic (Vol-II) dtd. 29-09-2021,
copy of the same attached for reference in dossier).
3. Documents for the procurement of Attested invoice from ADC attached for Ibuprofen
API with approval from DRAP (in Invoice No. W180316-035
case of import).
documents like chromatograms, Submitted
sheets etc.
on product testing
accelerated)
S.no. Observations/Deficiencies/ Reply of the Firm
Short-comings
1. Justify the dissolution parameter Firm replied that they adopted following
of applied drug product with dissolution condition and acceptance criteria
reference to dissolution medium, Proposed Dissolution conditions:
acceptance criteria and other 1. Dissolution Test parameter (Paracetamol):
dissolution conditions, i. Apparatus: Paddle ii. Dissolution
considering the USP general medium: Phosphate buffer pH 5.8 iii.
chapter <1092> and review report Medium volume: 900ml iv. RPM: 50 v.
of innovator product. Time: 30 minutes vi. Temperature: 37°C vii.
Acceptance Criteria: NLT 80% (Q) 2.
Dissolution Test parameter
2. (Ibuprofen): i. Apparatus: Paddle ii.
Dissolution medium: Phosphate buffer pH
7.2 iii. Medium volume: 900ml iv. RPM: 50
v. Time: 30 minutes vi. Temperature: 37°C
vii. Acceptance Criteria: NLT 80% (Q)
considering the guidance document: 1. USP chapter
1092 2. FDA guidance document for Dissolution
Testing and Acceptance Criteria for Immediate-
Release Solid Oral Dosage Form Drug Products
Containing High Solubility Drug Substances
(August 2018) 3. DRB Minutes of 293rd Meeting
of Registration Board (6 – 8th January, 2020) 4.
Pharmaceutical equivalence study with reference
product. 5. CDP study with reference product. 6.
Innovator review report (Nuromol tablet
200/500mg Reckitt Benckisar Healthcare, MHRA)
7. USP monograph of acetaminophen tablet.
2. Provide details that which lot Submitted
number of drug substance has
been used in manufacturing of
each batch of drug product. Also
provide documents confirming
evidence of import of each lot of
drug substance used in
manufacturing of these batches of
drug product.
Decision: Decision: Approvedwith innovator’s specifications. Registration letter will be
issued upon submission of performance of dissolution test as per dissolution parameters by
USFDA in the literature review of innovator alongwith fee of RS. 7,500/- for
revision/correction of drug product specifcations as per notification No.F.7-11/2012-
292. Name, address of Applicant / M/s Sami Pharmaceuticals, F-95, SITE, Karachi.
Name, address of Manufacturing site. Name: M/s Sami Pharmaceuticals, F-95, SITE,
Karachi.
☐ Importer
Details of fee submitted PKR 50,000/-: dated 09/03/2021 slip no.
2050054
LISTIM 150mg Injection
brand name
Strength / concentration of drug of Each vial contains:
Active Pharmaceutical ingredient Sterile Colistimethate sodium equivalent to Colistin
(API) per unit base ….150mg
USP Specs
Pharmaceutical form of applied drug Lyophilized Injection
Pharmacotherapeutic Group of (API) Polymixins
ATC code: J01XB
USP
specifications
Coly-Mycin M 150mg/2ml Injection
authorities
GMP certificate issued dated: 11-08-2020
manufacturer
Name and address of API Mac-Chem Products (India) Pvt. Ltd.
manufacturer. N-211/2/10.MIDC, Boisar, Thane-401506,
Maharashtra State, India
Module III (Drug Substance) Official monograph of Colistimethate Sodium is
tests for impurity & related substances
months
months
Batches:(CMT0219001, CMT0219002,
CMT0219003)
drug product.
comparative dissolution profile against the brand leader that is Coly-Mycin M
150mg/2ml Injection by ERFA Canada by
Sterility, bacterial endotoxin, pH, loss on drying,
Free colistin, appearance of reconstituted solution)
CDP is not applicable
validation/verification of product including linearity, accuracy, precision, specificity.
Manufacturer of API Mac-Chem Products (India) Pvt. Ltd.
API Lot No. CMS0217012
Description of Pack
10ml clear glass vial, USP Type-I
Frequency Accelerated: 0, 1,2,3,4, 6 (Months)
Manufacturing Date Nov 2019 Nov 2019 Nov 2019
Date of Initiation Dec 2019 Dec 2019 Dec 2019
No. of Batches 03
1. Reference of previous approval of The firm has submitted the relevant document.
2. Approval of API/ DML/GMP Copy of GMP certificate No. New-WHO-
certificate of API manufacturer issued GMP/CERT/KD/74238/2018/11/24897 issued by
by concerned regulatory authority of FDA valid till 10/09/2021
country of origin.
3. Documents for the procurement of Copy of letter No. MCEX180129 /DRAP-AD-CD
API with approval from DRAP (in (I&E) dated 13/2/2018 is submitted wherein the
case of import). permission to import different APIs including
Colistimethate sodium for the purpose of
sheets etc.
5. Compliance Record of HPLC Not applicable as not run on HPLC
on product testing
accelerated)
The median concentration i.e. U3 of Firm Stated that USP allows to adjust the Median
colistimethate sodium should be conc. To optimize the zone sizes if the data remain
1mcg/ml as per USP, while the submitted in the linear range (linearity has been verified), USP
assay method indicate that the median <81> chapter has been attached for reference.
concentration U3 was 5mcg/ml. However, the method of analysis is not as per USP,
Clarification is required in this regard. For the cylinder-plate assay, each plate includes only
For assay of drug substance, sample has two treatments, the reference treatment (median
been prepared using reference standard of level standard, i.e., S3) and one of the other four
colistimethate sodium, so concentrations of the standard (S1, S2, S4 and S5)
justification/clarification is required for or the sample (U3).
using standard material for preparation of Firm revised the method in accordance with USP.
sample stock solution.
Firm has submitted the reply that “it is a typo error,
for sample preparation we use the test sample,
accordingly worksheet has been revised and
attached.
Validation of analytical procedures Firm has submitted the reply that “Specificity was
done compartively with blank, standard and sample
, results are compared, method found selective that
Verification of analytical procedure has was missed in the method verification report,
not been performed in accordance with method verification report has been revised and
recommended USP. attached for ready reference”
How the specificity of method has been
verified without comparing the results of
sample with standard and placebo, as in
the submitted data sample solution has
not been prepared.
Reference Standards or Materials Firm submitted the COA of working standard
COA of primary/secondary reference supplied by API Manufacturer i.e. M/s. Mac-Chem
standard including source and lot no. is Products (India) Pvt. Limited batch no.
required. CMS0217012.
Component of drug product: Firm clarified that it is lyophilized cake as per the
Formulation Development innovator coly-Mycin but the label claim of product
According to the product description, it is will be written as Sterile colistimethate sodium
white to slightly yellow lyophilized cake equivalent to colistin base ….150mg as per the
of colistimethate sodium while the label innovator.
claim of product mentioned in the
pharmaceutical equivalence data is
“sterile lyophilized powder of
colistimethate sodium. Correction of
label claim is required accordingly.
Provide detail of type and quantity of Firm submitted following reply:
diluent used for reconstitution of applied We have developed LISTIM 150mg/2ml Injection
product. against the reference listed drug (RLD) i.e. Coly-
Inform about quantity of diluent used for Mycin M 150mg /2ml injection. Quantity and type
reconstitution when the product is used of diluents used are as under;
for inhalation as nebulizer solution. INTRAVENOUS OR INTRAMUSCULAR: 2ml of
Compatibility water for injection.
Provide compatibility studies data with Reference: Coly-Mycin M ® Parenteral
its diluent (Colistimethate for Injection, USP) (Distributed by
Provide compatibility study data of drug M/s. Par Pharmaceutical) -
product with its suitable diluent, after INHALATION AS NEBULIZER SOLUTION:
reconstitution as per the instructions LISTIM 150mg/2ml is Lyophilized powder for
provided in individual label of the drug injection only and product is not used for inhalation
product as nebulizer solution.
Compatibility Study data conducted with water for
injection, 0.9% NaCl, 5% Dextrose in water, 10%
inverted sugar solution, 5% Dextrose in 0.9% NaCl,
5% Dextrose in 0.45% NaCl, 5% Dextrose in
0.225% NaCl, Lactated Ringers Solution as per the
instruction on individual label of drug product has
been submitted by the firm.
Analytical procedure: Firm has stated that “This is typo error and sample
Sample stock solution has been prepared stock solution prepared using Water for Injection.
in distilled water while as per the Revised testing method has been submitted for ready
reference product, water for injection or reference”
0.9% sodium chloride should be used as
diluent for “colistimethate for injection”.
Justification is required for using distilled
water for preparation of sample solution.
The median concentration i.e. U3 Firm Stated that USP allows to adjust the Median
colistimethate sodium should be conc. To optimize the zone sizes if the data remain
1mcg/ml as per USP, while the submitted in the linear range (linearity has been verified), USP
assay method indicate that the median <81> chapter has been attached for reference.
concentration U3 was 5mcg/ml. However, the method of analysis is not as per USP,
Clarification is required in this regard. For the cylinder-plate assay, each plate includes only
two treatments, the reference treatment (median
level standard, i.e., S3) and one of the other four
concentrations of the standard (S1, S2, S4 and S5)
or the sample (U3). While, according to the
submitted assay procedure each plate contains three
treatments (S3, STANDARD and U3) which is not
in accordance to USP.
Firm submitted the revised analytical method in
Provide assay method for the infusion Firm has submitted that Colistimethate sodium
and inhalation route of administration, as 150mg injection will only be use for injection and
the amount of diluent will be varying same testing method will be used for the sample
accordingly for the preparation of sample preparation. LISTIM 150mg/2ml is Lyophilized
stock solution. powder for injection only and product is not used for
inhalation as nebulizer solution.
Justification is required for using ±5% Firm has submitted that “Basis for the limit of
acceptance criteria for weight variation, weight Variation is BP General Monograph
provide the calculation of acceptance (Consistency of formulated Preparation, sub
value as per USP. heading of Uniformity of Weight (Mass), which
allows the 10% weight variation for powder for
parenteral administration for more than 40mg
dosage form. We set the stringent of 5% instead of
10%. For the calculation of weight variation as per
USP, calculation sheet has been attached “
Analytical verification report reflects that Firm has replied that “It was typo error. For sample
weight of sample used for sample preparation we use the whole content of product.
solution is 240mg instead of 360mg The revised analytical verification report has been
(content per vial) attached for ready reference”.
justification/clarification required in this Firm has submitted the reply that “Specificity was
regard. done compartively with blank, standard and sample
How the specificity of method has been , results are compared, method found selective that
verified without comparing the results of was missed in the method verification report,
sample with standard and placebo, as in method verification report has been revised and
the submitted data sample solution has attached for ready reference”
not been prepared.
Batch Analyses Firm has submitted that “appearance of lyophilized
Appearance of lyophilized cake should cake has been revised/amended in the batch analysis
be mentioned on batch analysis report report. In the batch analysis report this is missed
rather the appearance of powder of although available on raw data sheet. Batch analysis
colistimethate sodium for injection. report amended and attached for ready reference”.
Acceptance criteria of assay is not as per Firm has stated that results obtained by our
labelled claimed of USP monograph of calculation is labelled amount of Colistin according
“Colistimethate for Injection”. It is not to USP
clear that the given percentage is of
colistin or Colistimethate sodium.
Stability Firm submitted the reply that Appearance of
Appearance of lyophilized cake should lyophilized cake has been revised/amended in the
be mentioned on stability data sheets batch analysis report. The amended stability data
sheets have been attached for ready reference.
rather the appearance of powder of Firm has submitted the in-use stability studies data
Colistimethate sodium for injection. at storage condition 2-8°c and 20-25°C for 7 days.
Provide in use stability data of
reconstituted solution along with give the
detail of proposed in-use storage
statement and in-use shelf-life.
Decision of 316th meeting of Registration Board:
Deferred for further deliberation regarding the label claim of Colistimethate sodium in line with
the product approved in reference regulatory agencies and pharmacopeia.
Decision: Deferred for following clarification:
• Manufacturing facility (lyophilized or dry powder filling) wherein the trial batches
have been manufactured along with evidence of approval of required manufacturing
facility from CLB.
• Applied label claim against the recommendations of USP monograph of
Colistimethate for injection.
Karachi.
☐ Importer
Details of fee submitted PKR 20,000/-: dated 28/02/2021 slip no. 2050087
LISTIM 1 MIU Injection
brand name
Active Pharmaceutical ingredient Sterile powder of Colistimethate Sodium USP….1
(API) per unit MIU
(1 Million International Unit)
USP Specs
Pharmaceutical form of applied drug Dry powder Injection
ATC code: J01XB
USP
specifications
Colomycin 1 MIU Injection UK MHRA
authorities
For generic drugs (me-too status) Colimate by MTI Medical Limited (Reg. 097779)
GMP status of the Finished product GMP Certificate issued date 11-08-2020
manufacturer
Name and address of API Livzon Group Fuzhou Fuxing Pharmaceutical Co.
manufacturer. Ltd.
No. 8 Nangang Road, Jiangyin Industrial
Concentration Zone, Fuqing, Fuzhou City, Fujian
Province, P.R China,350309
tests for impurity & related substances,
months
Batches: (CMS1707001, CMS1707002,
CMS1707003)
drug product.
comparative dissolution profile against the brand leader that is Colomycin Injection
1 MIU Injection by Penn Pharmaceutical services
Tredegar Gwent NP223AA, UK by performing
quality tests (Identification, Assay, Sterility,
bacterial endotoxin, pH, loss on drying, Free
colistin, appearance of reconstituted solution)
Manufacturer of API Livzon Group Fuzhou Fuxing
Description of Pack
10ml clear glass vial, USP Type-I
Manufacturing Date Oct 2019 Oct 2019 Oct 2019
Date of Initiation Oct 2019 Oct 2019 Oct 2019
No. of Batches 03
Reference of previous approval of The firm has submitted the relevant document.
Approval of API/ DML/GMP Copy of GMP certificate No. FJ200006 issued by
certificate of API manufacturer issued Fujian FDA valid till 21/09/2022
country of origin.
Documents for the procurement of Firm has submitted copy of invoice specifying
API with approval from DRAP (in import of 1 kg of Colistimethate Sodium (Batch #
case of import). CMS181101). (invoice # FXIN1812252) attested by
AD (I&E), Karachi dated 11/1/2019
Data of stability batches will be Submitted
sheets etc.
Compliance Record of HPLC Not applicable as not run on HPLC
on product testing
Record of Digital data logger for Submitted
accelerated)
Control of Drug Substance Firm Stated that USP allows to adjust the
Analytical procedures Median conc. to optimize the zone sizes if the
The median concentration i.e. U3 of data remain in the linear range (linearity has
colistimethate sodium should be 1mcg/ml as been verified), USP <81> chapter has been
per USP, while the submitted assay method attached for reference.
indicate that the median concentration U3 However, the method of analysis is not as per
was 5mcg/ml. Clarification is required in this USP, For the cylinder-plate assay, each plate
regard. includes only two treatments, the reference
treatment (median level standard, i.e., S3) and
one of the other four concentrations of the
standard (S1, S2, S4 and S5) or the sample (U3).
While, according to the submitted assay
procedure each plate contains three treatments
(S3, STANDARD and U3) which is not in
accordance to USP.
For assay of drug substance, sample has been Firm has submitted the reply that “it is a typo
prepared using reference standard of error, for sample preparation we use the test
colistimethate sodium, so sample, accordingly worksheet has been revised
justification/clarification is required for and attached.
using standard material for preparation of
sample stock solution.
Validation of analytical procedures Firm has submitted the reply that “Specificity
How the specificity of method has been was done compartively with blank, standard and
verified without comparing the results of sample , results are compared, method found
sample with standard and placebo, as in the selective that was missed in the method
submitted data sample solution has not been verification report, method verification report
prepared. has been revised and attached for ready
reference”.
Method verification protocol submitted along
with the reply reflects that the API manufacturer
is M/s. Mac-Chem Products (India) Pvt. Ltd.
while the CTD dossier submitted previously
shows that the API manufacturer is M/s. Livzon
Group Fuzhou Fuxing Pharmaceuticals, China.
Component of drug product: We have developed LISTIM 1 MIU Injection
Formulation Development against the reference listed drug (RLD) i.e.
Provide detail of type and quantity of diluents Colomycin 1 Million International Units (IU)
used for reconstitution of applied product. Powder for solution for injection, infusion or
Inform about quantity of diluent used for inhalation. The package leaflet of RLD
reconstitution when the product is used for Colomycin 1 Million International Units (IU)
inhalation as nebulizer solution. Powder for solution for injection, infusion or
Compatibility inhalation, (Marketing authorization holder
Provide compatibility studies data with its M/s. Forest Laboratories UK Limited whiddon
diluent valley, Barnstaple, North Devon EX32 8NS
Provide compatibility study data of drug United Kingdom) has been attached for
product with its suitable diluent, after reference. Quantity and type of diluents used are
reconstitution as per the instructions as under;
provided in individual label of the drug BOLUS INJECTION: 2ml of water for
product injection or 0.9% sodium chloride
INFUSION: Reconstituted vial will be further
diluted in 50 ml 0.9% sodium chloride solution
INTRATHECAL AND
INTRAVENTRICULAR: Not more than 1 ml
of water for injection or 0.9% sodium chloride
will be used for reconstitution.
INHALATION AS NEBULIZER SOLUTION:
2ml of water for injection or saline (0.9%
sodium chloride solution) for reconstitution
when the product is used for inhalation as
nebulizer solution.
Firm has submitted compatibility and in-use
stability studies with water for injection and
Sterile sodium chloride sol (0.9%), on 3 batches
at the start of study and at 18th Month, interval.
summary report and raw data has attached.
Before opening: 3 years.
Reconstituted solutions: Hydrolysis of
colistimethate is significantly increased when
reconstituted and diluted below its critical
micelle concentration of about 80,000 IU per
ml. Solutions below this concentration should
be used immediately
For solutions for bolus injection or nebulization,
the chemical and physical in-use stability of
reconstituted solution in the original vial, with a
concentration ≥ 80,000 IU/mL, has been
demonstrated for 24 hours at 2 to 8°C.
From a microbiological point of view, unless
the method of opening/ reconstitution/ dilution
precludes the risk of microbial contamination,
the product should be used immediately.
If not used immediately, in-use storage times
and conditions are the responsibility of user.
Solutions for infusion, which have been diluted
beyond the original vial volume and / or with a
concentration < 80,000 IU/mL should be used
immediately.
For solutions for intrathecal and
intraventricular administration, the
reconstituted product should be used
immediately.
Analytical procedure: Firm stated that “it was the typo error we
Sample stock solution has been prepared in actually use water for injection for
distilled water while as per the reference reconstitution of sample. The method has been
product, water for injection or 0.9% sodium revised and attached”.
chloride should be used as diluent for
“colistimethate for injection”. Justification is
required for using distilled water for
preparation of sample solution.
The median concentration i.e. U3 of Firm Stated that USP allows to adjust the
colistimethate sodium should be 1mcg/ml as Median conc. to optimize the zone sizes if the
per USP, while the submitted assay method data remain in the linear range (linearity has
indicate that the median concentration U3 been verified), USP <81> chapter has been
was 5mcg/ml. Clarification is required in this attached for reference.
regard. However, the method of analysis is not as per
USP, For the cylinder-plate assay, each plate
includes only two treatments, the reference
treatment (median level standard, i.e.,
S3) and one of the other four concentrations of
the standard (S1, S2, S4 and S5) or the sample
(U3).
While, according to the submitted assay
procedure each plate contains three treatment
accordance to USP.
Provide assay method for the infusion and Firm stated that the constitution volume for both
inhalation route of administration, as the infusion and inhalation route of administration
amount of diluent will be varying is same i.e. 2ml of water for injection or 0.9 %
accordingly for the preparation of sample saline, therefore same method will be applied
stock solution. Volume of diluent used for reconstitution is
different for intrathecal/intraventricular route of
administration and for infusion and according to
USP monograph for sample preparation
“Constitute Colistimethate for Injection in a
volume of water, accurately measured,
corresponding to the volume of diluent
specified in the labeling.”
Analytical verification report of drug product Firm stated that It was typo graphical error, the
reflects that weight of sample used for amount of standard used was 240 mg and the
sample solution is 240mg instead of 80mg vial of sample directly reconstituted with
(content per vial) justification/clarification diluent. Revised method and report have been
required in this regard. attached.
How the specificity of method has been Firm has submitted the reply that “Specificity
verified without comparing the results of was done compartively with blank, standard
sample with standard and placebo, as in the and sample , results are compared, method
submitted data sample solution has not been found selective that was missed in the method
prepared. verification report, method verification report
has been revised and attached for ready
reference”.
Batch Analyses Firm has stated that results obtained by our

Acceptance criteria of assay is not as per calculation is labelled amount of Colistin
labelled claimed of USP monograph of according to USP.
“colistimethate for Injection”. It is not clear
that the given percentage is of colistin or
colistimethate sodium.
Reference Standards or Materials The material supplied by MAC-chem Products
Working standard supplied by MAC-chem (India) was tested against reference standard
Products (India) has been used while the drug and same lot is standardized against USP
substance manufacturer used USP reference reference standard and use accordingly.
standard. Justification is required for not However, the API manufacturer is M/s. Livzon
using the primary standard or the working Group Fuzhou Fuxing Pharmaceuticals, China
standard supplied by the drug substance as per the CTD dossier.
manufacturer.
Stability Firm has submitted the in-use stability data and
Provide in use stability data of reconstituted
the proposed in-use storage statement and in-
solution along with give the detail of use shelf life is as under:
proposed in-use storage statement and in-useStore at 2-8°C for 24hours
shelf-life. After 24hours of reconstitution the product
found stable with respect to quality, strength
and compatibility
th
facility from CLB.
Karachi.
☐ Importer
Details of fee submitted PKR 20,000/-: dated 28/02/2021 SLIP NO. 2050089
LISTIM 2 MIU Injection
brand name
Active Pharmaceutical ingredient Sterile powder of Colistimethate sodium USP….2
(API) per unit MIU
(2 Million International Unit)
USP Specs
Pharmaceutical form of applied drug Dry powder Injection
ATC code: J01XB
USP
specifications
Colomycin 2 MIU Injection MHRA
authorities
For generic drugs (me-too status) Colistimethate Sodium powder for Injection 2MIU
of M/s. Mukhtar Enterprises (Reg.no.094757)
GMP certificate issued dated: 11-08-2020
manufacturer
Name and address of API Livzon Group Fuzhou Fuxing Pharmaceutical Co.
manufacturer. Ltd.
No. 8 Nangang Road, Jiangyin Industrial
Concentration Zone, Fuqing, Fuzhou City, Fujian
Province, P.R China,350309
months
Batches: (CMS1707001, CMS1707002,
CMS1707003)
drug product.
comparative dissolution profile against the brand leader that is Colomycin Injection
1 MIU Injection by Penn Pharmaceutical services
Tredegar Gwent NP223AA, UK by performing
quality tests (Identification, Assay, Sterility,
bacterial endotoxin, pH, loss on drying, Free
colistin, appearance of reconstituted solution)
Manufacturer of API Livzon Group Fuzhou Fuxing
Description of Pack 10ml clear glass vial, USP Type-I
Manufacturing Date Oct 2019 Oct 2019 Oct 2019
Date of Initiation Nov 2019 Nov 2019 Nov 2019
No. of Batches 03
1. Reference of previous approval of The firm has submitted the relevant document.
2. Approval of API/ DML/GMP Copy of GMP certificate No. FJ200006 issued by
certificate of API manufacturer issued Fujian FDA valid till 21/09/2022
country of origin.
3. Documents for the procurement of Firm has submitted copy of invoice specifying
API with approval from DRAP (in import of 1 kg of Colistimethate Sodium (Batch #
case of import). CMS181101). (invoice # FXIN1812252) attested by
AD (I&E), Karachi dated 11/1/2019
sheets etc.
5. Compliance Record of HPLC Not applicable as not run on HPLC
on product testing
accelerated)
Control of Drug Substance Firm Stated that USP allows to adjust the Median
Analytical procedures conc. to optimize the zone sizes if the data
The median concentration i.e. U3 of remain in the linear range (linearity has been
colistimethate sodium should be 1mcg/ml as verified), USP <81> chapter has been attached
per USP, while the submitted assay method for reference.
indicate that the median concentration U3 However, the method of analysis is not as per
was 5mcg/ml. Clarification is required in this USP, For the cylinder-plate assay, each plate
regard. includes only two treatments, the reference
For assay of drug substance, sample has been treatment (median level standard, i.e.,
prepared using reference standard of S3) and one of the other four concentrations of
colistimethate sodium, so the standard (S1, S2, S4 and S5) or the sample
justification/clarification is required for (U3). While, according to the submitted assay
using standard material for preparation of procedure each plate contains three treatments
sample stock solution. (S3, STANDARD and U3) which is not in
accordance to USP.
Firm has submitted the reply that “it is a typo
error, for sample preparation we use the test
sample, accordingly worksheet has been revised
and attached.
Validation of analytical procedures Firm has submitted the reply that “Specificity
How the specificity of method has been was done comparatively with blank, standard
verified without comparing the results of and sample, results are compared, method found
reference”.
Method verification protocol submitted along
with the reply reflects that the API manufacturer
is M/s. Mac-Chem Products (India) Pvt. Ltd.
while the CTD dossier submitted previously
shows that the API manufacturer is M/s. Livzon
Group Fuzhou Fuxing Pharmaceuticals, China.
Pharmaceutical equivalence should be For comparative analysis against the reference-
established against the listed drug (RLD) COLOMYCIN Injection, we
innovator/reference/comparator product of were only able to procure samples of
the same strength. Provide the comparison COLOMYCIN 1MIU Injection and unable to
data with the reference product of same arrange COLOMYCIN 2MIU due to
strength. international availability issues arising from
ongoing pandemic situation.
The literature data of reference-listed drug
(Innovator product) revealed that, their product
is ready-to-fill sterile powder injection and the
formulation only contains API having no other
excipients. The same has been confirmed on the
testing of COLOMYCIN 1 MIU Injection at our
end. The only difference between 1MIU &
2MIU injection is the fill weight, similarly we
also used the same criteria for the development
of our products i.e. weight multiplication, and
comparative analysis have been performed
against COLOMYCIN 1MIU strength, that fulfil
the requirements.
We have developed LISTIM 2 MIU Injection
against the reference listed drug (RLD) i.e.
Colomycin 2 Million International Units (IU)
Powder for solution for injection, infusion or
inhalation.
Component of drug product: We have developed LISTIM 2 MIU Injection
Formulation Development against the reference listed drug (RLD) i.e.
Provide detail of type and quantity of diluents Colomycin 2 Million International Units (IU)
used for reconstitution of applied product. Powder for solution for injection, infusion or
Inform about quantity of diluent used for inhalation. Quantity and type of diluents used are
reconstitution when the product is used for as under;
inhalation as nebulizer solution. BOLUS INJECTION: 4ml of water for injection
Compatibility or 0.9% sodium chloride
Provide compatibility studies data with its INFUSION: Reconstituted vial will be further
diluent diluted in 50 ml 0.9% sodium chloride solution
Provide compatibility study data of drug INTRATHECAL AND
product with its suitable diluent, after INTRAVENTRICULAR: Not more than 1 ml of
reconstitution as per the instructions water for injection or 0.9% sodium chloride will
provided in individual label of the drug be used for reconstitution
product INHALATION AS NEBULIZER SOLUTION:
4ml of water for injection or saline (0.9% sodium
chloride solution) for reconstitution when the
product is used for inhalation as nebulizer
solution.
Before opening: 3 years.
Reconstituted solutions: Hydrolysis of
Colistimethate is significantly increased when
reconstituted and diluted below its critical
micelle concentration of about 80,000 IU per ml.
Solutions below this concentration should be
used immediately
For solutions for bolus injection or nebulization,
the chemical and physical in-use stability of
reconstituted solution in the original vial, with a
concentration ≥ 80,000 IU/mL, has been
demonstrated for 24 hours at 2 to 8°C.
From a microbiological point of view, unless the
method of opening/ reconstitution/ dilution
precludes the risk of microbial contamination,
the product should be used immediately.
If not used immediately, in-use storage times and
conditions are the responsibility of user.
Solutions for infusion, which have been diluted
beyond the original vial volume and / or with a
concentration < 80,000 IU/mL should be used
immediately.
For solutions for intrathecal and intraventricular
administration, the reconstituted product should
be used immediately.
Analytical procedure: Firm stated that “it was the typo error we actually
Sample stock solution has been prepared in use water for injection for reconstitution of
distilled water while as per the reference sample. The method has been revised and
product, water for injection or 0.9% sodium attached”.
chloride should be used as diluent for
“Colistimethate for injection”. Justification is
required for using distilled water for
preparation of sample solution.
The median concentration i.e. U3 of Firm Stated that USP allows to adjust the Median
Colistimethate sodium should be 1mcg/ml as conc. to optimize the zone sizes if the data
per USP, while the submitted assay method remain in the linear range (linearity has been
indicate that the median concentration U3 verified), USP <81> chapter has been attached
for reference.
was 5mcg/ml. Clarification is required in this However, the method of analysis is not as per
regard. USP, For the cylinder-plate assay, each plate
includes only two treatments, the reference
treatment (median level standard, i.e.,
S3) and one of the other four concentrations of
the standard (S1, S2, S4 and S5) or the sample
(U3). While, according to the submitted assay
procedure each plate contains three treatments
accordance to USP.
Provide assay method for the infusion and Firm stated that the constitution volume for both
inhalation route of administration, as the infusion and inhalation route of administration is
amount of diluent will be varying same i.e. 2ml of water for injection or 0.9 %
accordingly for the preparation of sample saline, therefore same method will be applied
stock solution. Volume of diluent used for reconstitution is
different for intrathecal/intraventricular route of
administration and for infusion and according to
USP monograph for sample preparation
“Constitute Colistimethate for Injection in a
volume of water, accurately measured,
corresponding to the volume of diluent specified
in the labeling.”
Analytical verification report reflects that Firm stated that It was typo graphical error, the
weight of sample used for sample solution is amount of standard used was 240 mg and the vial
240mg instead of 160mg (content per vial) of sample directly reconstituted with diluent.
justification/clarification required in this Revised method and report have been attached.
regard. Firm has submitted the reply that “Specificity
How the specificity of method has been was done compartively with blank, standard and
verified without comparing the results of sample, results are compared, method found
reference”.
Acceptance criteria of assay is not as per Firm has stated that results obtained by our
labelled claimed of USP monograph of calculation is labelled amount of Colistin
“Colistimethate for Injection”. It is not clear according to USP.
that the given percentage is of colistin or
Colistimethate sodium.
Working standard supplied by MAC-chem The material supplied by MAC-chem Products
Products (India) has been used while the drug (India) was tested against reference standard and
substance manufacturer used USP reference same lot is standardized against USP reference
standard. Justification is required for not standard and use accordingly.
using the primary standard or the working However, the API manufacturer is M/s. Livzon
standard supplied by the drug substance Group Fuzhou Fuxing Pharmaceuticals, China
manufacturer. as per the CTD dossier.
Provide in use stability data of reconstituted Firm has submitted the in-use stability data and
solution along with give the detail of the proposed in-use storage statement and in-use
proposed in-use storage statement and in-use shelf life is as under:
shelf-life. Store at 2-8°C for 24hours
After 24hours of reconstitution the product
found stable with respect to quality, strength and
compatibility
th
facility from CLB.
295. Name, address of Applicant / M/s Jawa Pharmaceuticals Private Limited 112/10
Marketing Authorization Holder Quaid e Azam Industrial Area Kot Lakhpat Lahore
Name, address of Manufacturing site. M/s Jawa Pharmaceuticals Private Limited 112/10
Quaid e Azam Industrial Area Kot Lakhpat Lahore
☐ Importer
Dy. No. and date of submission Dy.no. 13397 dated 18/05/2021
Details of fee submitted PKR 20,000/-: dated 28/07/2020 slip no.2031157
Jawaflox 0.3% Ophthalmic Solution
brand name
Strength / concentration of drug of Each ml contains
Active Pharmaceutical ingredient Ciprofloxacin HCl e.q. Ciprofloxacin… 3mg (0.3%)
(API) per unit
Pharmaceutical form of applied drug Cleared slightly Yellow colored solution for
Ophthalmic use only
Pharmacotherapeutic Group of (API) Quinolone class of anti-bacterial
USP
specifications
The status in reference regulatory Ciloxan 0.3% eye drops
authorities Alcon USA Approved
For generic drugs (me-too status) Ciloxan 0.3% Reg.no. 016754
Novartis Pharma Ltd.
GMP status of the Finished product GMP certificate granted on 06/07/2020 Valid for 2
manufacturer Years
Ophthalmic section approved.
Name and address of API M/s Citi Pharma Pvt Ltd.
manufacturer. Head Balloki Road, Phool Nagar, Kasur, Pakistan
Module III (Drug Substance) Official monograph of ciprofloxacin is present in
process and controls, tests for impurity
fluoroqinolonic acid, specifications, analytical
drug substance.
months
Used factor as per ICH guidelines
Batches: (T1, T2, T3)

verification studies, batch analysis and justification
Pharmaceutical equivalence. Pharmaceutical Equivalence have been established
against the ophthalmic solution (ciprofloxacin HCl)
by performing quality tests (Identification, pH
Assay)
validation/verification of product including accuracy, precision, specificity.
Manufacturer of API M/s Citi Pharma Pvt Ltd. Head Balloki Road, Phool Nagar, Kasur,
Pakistan
API Lot No. CPH1908055
Description of Pack White opaque LDPE bottle with polypropylene nozzle and high-
(Container closure system) density polyethylene (HDPE) cap.1 x 1`s
Used factor of water loss as per ICH guidelines
Real Time: 0, 3, 6 ,9, 12, 18, 24 (Months)
Batch Size 3L (600 bottles) 3L (600 bottles) 3L (600 bottles)
No. of Batches 03
2. Approval of API/ DML/GMP Copy of GMP certificate No. K0708 issued by
certificate of API manufacturer issued CFDA valid till 27/11/2023
country of origin.
3. Documents for the procurement of Submitted
case of import).
4. Data of stability batches will be Not Submitted
sheets etc.
5. Compliance Record of HPLC Comply
on product testing
accelerated)
Ophthalmic general section has not been Firm has submitted the grant of additional
mentioned in CGMP certificate issued dated section letter specified that firm has ophthalmic
06-07-2020 and in Renewal letter of Drug (general) section issued dated 25, June,2019 vide
manufacturing License issued dated 17th letter no. F.1-38/91-Lic (Vol-I).
July, 2019.Section approval letter of
ophthalmic solution is required.
Control of Drug Substance Firm has submitted the analytical procedure for
Analytical procedures testing of drug substance according to USP
Provide detailed analytical procedures for the monograph.
testing of drug substance.
Validation of analytical procedures Firm has submitted the method verification
Provide analytical Method Verification studies of drug substance performed by the drug
studies including specificity, accuracy and product manufacturer.
repeatability performed by the Drug Product However, the solution preparation methods are
manufacturer. not in accordance with USP, as in the USP
mobile phase has been used for the preparation
of sample and standard solution while firm used
distilled water first and then make up the volume
with mobile phase for preparation of solution.
Component of drug product: Firm has submitted the revised pharmaceutical
Formulation Development equivalence data in which the pH of both the
Acceptance limit of pH of ciprofloxacin applied and innovator drug product is in the
ophthalmic solution as per USP is 3.5-5.5 range recommended by USP i.e. 3.5-5.5, but the
while pharmaceutical equivalence table reference product used for equivalence study is
reflect that the pH of applied and reference vigamox ophthalmic solution which is the
drug product is 6.76 and 6.8 respectively. innovator brand of moxifloxacin hydrochloride.
Justification/clarification is required in this
regard.
Microbiological Attributes Firm has submitted the preservative efficacy
Formulation contain preservative, so studies data.
preservative effectiveness studies to be But how the firm performed preservative
performed as per recommendations of efficacy test prior the manufacturing of stability
pharmacopoeia and shall be submit. batches, as the stability batches were
manufactured in the month of feb,2020, while
the batch used for preservative test was
manufactured in dec,2019 and test date was
jan,2020.
Further, the test results of all the recent applied
ophthalmic solution are similar.
Control of Drug Product Firm has submitted the analytical procedure for
Analytical procedure for the determination of the determination of pH, sterility and bacterial
pH, sterility and bacterial endotoxin limit and endotoxin limit and osmolality/osmolarity of
osmolality/osmolarity of ophthalmic solution drug product.
has not been provided.
Batch analysis Firm has provided the batch analysis report of
The copies of complete analysis of at least three batches.
two batches shall be provided.
Validation of analytical procedures Firm has submitted the revised analytical method
Justification of performing specificity verification studies of drug product which is also
parameter without determining not in accordance with USP monograph in terms
placebo/diluent to demonstrate the absence of method of preparation of solutions (sample
of interference with the elution of analyte. and standard solutions).
According to ICH Q2 R1 guidelines for As per USP monograph sample and standard
repeatability a minimum of 9 determinations solutions has been prepared in water while the
covering the specified range for the submitted studies evident the solution has been
procedure (e.g., 3 concentrations/3 replicates prepared in mobile phase.
each); or a minimum of 6 determinations at Submitted chromatograms did not mention the
100% of the test concentration are used. date of requisition and processing of sample.
Justification is required for using five
determinants along with provide the detail of
concentration of test sample used to assessed
the repeatability parameter.
Elaborate following for the performance of
accuracy parameter:
Preparation of standard solution
Preparation of sample solution
Preparation of placebo solution preparation
Concentration range of sample solution used
to determine the percentage recovery.
Stability Firm has submitted revised stability study data of
Provide raw data sheet reflecting the method 3 batches of drug product at both accelerated as
of preparation of standard solution, sample well as real time conditions.
solution, formula for calculation of assay Revised stability study shows that at zero-time
content, calculation for determination of point percentage water loss is 0% and result of
water loss content. osmolarity has been included in the stability data
How percentage of water loss has been sheet.
calculated at zero-time point during stability
studies. Provide the detail calculation Firm has not submitted the raw data sheet
performed to obtained the water loss using reflecting the method of preparation of standard
the factor 3 and 1.8 at the initial time point. solution, sample solution, formula for
calculation of assay content, calculation for
determination of water loss content.
Water loss study performed for LDPE Firm stated that “as our all ophthalmic products
container as per the Asian Guidelines on has same manufacturing method and water
stability study of drug product under the based, placed on same stability conditions and
recommended condition of temperature and same semi-preamble packaging (LDPE Bottles).
humidity i.e. 40℃/25% (factor 3.0) and So, our water loss results have variations in
30℃/35% (factor 1.8) have same results of % points. We have already attached the data logger
water loss for all the applied ophthalmic of stability data in dossier which shows that same
solution, justification/clarification is required conditions applied which cause same results of
in the regard. water loss studies with just points variations”.
Executed Production Documents: Firm has submitted copy of BMR of three

Provide copy of Batch Manufacturing stability batches. However, the following
Record (BMR) for all the batches of drug discrepancies has been observed in the submitted
product for which stability studies data is BMR:
provided in Module 3 section 3.2. P.8.3. Justification is required for autoclaving of bulk
solution in the glass container for all three
stability batches.
Bulk solution is autoclaved in closed Glass
container before filing because ophthalmic
solutions are filled in LDPE vials which cannot
be sterilized by terminal sterilization.
Sterilization by Filtration is also done by 0.2µm
and 0.45µm filters. LDPE plastic vials for
ophthalmic solution filling are received as
sterilized.
Not every Solution is sterilized by autoclave
before filling.
Evidence of availability of large capacity closed
glass containers for autoclaving of commercial
batches and autoclave of large capacity.
Volume of HCL/NaOH has been used for the

adjustment of pH of the ophthalmic solution was
not mentioned in all three BMRs.
pH of the solution was adjusted by using 1N
HCl. Quantity of 1N HCl solution used for
adjusting pH of the solution was 1.0ml
th
Deferred for the submission of following:
Justification for reporting Pharmaceutical equivalence studies of Ciprofloxacin against the
innovator brand of moxifloxacin HCl i.e. Vigamox.
Justify, how the bulk ophthalmic solution of commercial batches will be sterilized in the autoclave,
and provide evidence of availability of large capacity closed glass containers for autoclaving of
commercial batches and autoclave of such large capacity.
Scientific justification for using an entirely different formula for calculation of assay results of
stability batches from that specified in USP monograph and rationale of the results reported on
basis of this calculation formula.
Scientific justification for variation in the sample & standard solution preparation method from that
specified in the USP monograph of “Ciprofloxacin Ophthalmic solution”.
Justification regarding, how the firm performed preservative efficacy test prior to manufacturing
of stability batches.
Scientific justification for submitting same water loss study data in all applied ophthalmic solution
products.
Reply of the Firm:
Sr.n Decision of 316th meeting of Reply of the Firm
o. Registration Board
1. Justification for reporting Firm claimed that only the name in heading of
Pharmaceutical equivalence studies pharmaceutical equivalence report was
of Ciprofloxacin against the mistakenly written as vigamox, otherwise the
innovator brand of moxifloxacin results are same as compared with innovator
HCl i.e. Vigamox. product.
However, the specifications and label claim of
ophthalmic solution is not in accordance with
USP monograph of ciprofloxacin ophthalmic
solution.
2. Justify, how the bulk ophthalmic solution of commercial batches will be sterilized in the
autoclave, and provide evidence of availability of large capacity closed glass containers
for autoclaving of commercial batches and autoclave of such large capacity.
Firm claimed that they sterilized the container in which the bulk solution will be prepared
prior manufacturing of bulk solution, further the bulk solution will be filter through 0.2µ
filter paper and then the filling procedure will be done under aseptic condition.
Terminal sterilization of ophthalmic solution will not be done because the primary
container of ophthalmic solution is LDPE bottle.
3. Scientific justification for using an Firm submitted the revised assay testing
entirely different formula for procedure in accordance with USP monograph of
calculation of assay results of ciprofloxacin ophthalmic solution.
stability batches from that specified
in USP monograph and rationale of
the results reported on basis of this
calculation formula.
4. Scientific justification for variation Firm submitted the revised assay testing
in the sample & standard solution procedure in accordance with USP monograph of
preparation method from that ciprofloxacin ophthalmic solution.
specified in the USP monograph of
“Ciprofloxacin Ophthalmic
solution”.
5. Justification regarding, how the firm performed preservative efficacy test prior to
manufacturing of stability batches.
Firm submitted the revised preservative efficacy test report of all three trial batches,
which is again performed prior manufacturing of each trial batches:
T-01 T-02 T-03
Mfg date: Mfg date: Mfg date:
05-02-2020 06-02-2020 07-02-2020
Performance of preservative Performance of Performance of preservative
efficacy test in january-2020 preservative efficacy test in january-2020
efficacy test in
january-2020
6. Scientific justification for submitting same water loss study data in all applied
ophthalmic solution products.
Firm submitted the reply that “We have already provided justification for same water
loss study results (We had purchased LDPE bottles from Pak Nationals Limited which
was used for all ophthalmic preparation’s trial batches of the same batch. The
temperature, humidity conditions was same for all preparations, even the preparation
also done on oil base method which leads to same water loss results with changes in
points.”
Decision: Approved.
• Registration letter will be issued after submission of documents related to
performance of next time point of long term stability studies as per USP monograph,
Pharmaceutical equivalence studies performed against the
innovator/reference/comparator product, preservative efficacy test performed in
accordance with general guidance chapter of Pharmacoepias and updated water loss
study alongwith fee of Rs. 7500/- for correction/pre-approval change in product
296. Name, address of Applicant / M/s Jawa Pharmaceuticals Private Limited112/10
Name, address of Manufacturing site. M/s Jawa Pharmaceuticals Private Limited
112/10 Quaid e Azam Industrial Area Kot Lakhpat
Lahore
☐ Importer
Dy. No. and date of submission Dy.no.13398 dated 18/05/2021
Jfenac 0.1% Ophthalmic solution
brand name
Active Pharmaceutical ingredient Diclofenac Sodium … 1mg (0.1%)
(API) per unit
Pharmaceutical form of applied drug Clear and colorless solution for Ophthalmic use only
Pharmacotherapeutic Group of (API) NSAID
Manufacturer’s Specification
specifications
The status in reference regulatory USFDA approved Voltarol Ophtha Thea
authorities Pharmaceuticals Ltd.
For generic drugs (me-too status) Oclonac 0.1% eye drops Barrett Hodgson
(Reg.no.039728)
manufacturer Years
Name and address of API M/s Henan Dongtai Pharma Co. Ltd China
manufacturer.
Module III (Drug Substance) Official monograph of Diclofenac Sodium is present
tests for impurity A and related substances,
months

against the brand leader that is Voltarol 0.1% eye
drops by Thea Pharmaceutical by performing
quality tests (Identification, pH and Assay)
Manufacturer of API M/s Henan Dongtai Pharma Co. Ltd China
(Container closure system) density polyethylene (HDPE) cap.
1 x 1`s
Real Time: 0, 3, 6 ,9, 12, 18, 24 (Months)
Batch Size 3L (600 3L (600 bottles) 3L (600 bottles)
bottles)
No. of Batches 03
2. Approval of API/ DML/GMP Copy of GMP certificate No. HA20170001 issued
certificate of API manufacturer issued by CFDA valid till 22/01/2022.
country of origin.
3. Documents for the procurement of Already registered product
API with approval from DRAP (in Copy of letter No.8111/2020/DRAP-AD-CD(I&E)
case of import). dated 11/12/2020
sheets etc.
on product testing
accelerated)
Ophthalmic general section has not been Firm has submitted the grant of additional
mentioned in CGMP certificate issued dated section letter specified that firm has ophthalmic
06-07-2020 and in Renewal letter of Drug (general) section issued dated 25, June,2019 vide
manufacturing License issued dated 17th letter no. F.1-38/91-Lic (Vol-I).
3.2S.4.2: Analytical procedures Firm has submitted the analytical procedure for
Provide detailed analytical procedures for testing of drug substance according to BP
the testing of drug substance. monograph of Diclofenac Sodium in which the
assay has been performed on potentiometer.
3.2S.4.3: Validation of analytical Firm has submitted the method verification
procedures studies of drug substance performed by the drug
Provide analytical Method Verification product manufacturer.
studies including specificity, accuracy and However, the assay method is not as per the BP
repeatability performed by the Drug monograph for diclofenac sodium.
Batch analysis Firm has not submitted the results of analysis of
Provide results of analysis of relevant relevant batches of Drug Substance performed by
batches of Drug Substance performed by Drug Product manufacturer used during product
Drug Product manufacturer used during development and stability studies, along with
product development and stability studies, Certificate of Analysis (CoA) of the same batch
along with Certificate of Analysis (CoA) of from Drug Substance manufacture.
the same batch from Drug Substance
manufacture.
Description and Composition of the Drug Firm has not provided any justification regarding
Product the overage of diclofenac sodium used in the
Amount of diclofenac sodium used in the formulation i.e. 1.1mg/ml, while as per reference
formulation is 1.1mg/ml as per reference product it is 1mg/ml.
product it is 1mg/ml. Scientific justification
is required for using overage of active
ingredient in the formulation.
Component of drug product: Firm has not submitted the compatibility studies
Drug substance of drug substance with excipient.
Provide compatibility studies of the Drug
Substance(s) with excipients as the
qualitative composition of the formulation
is not similar to innovator / reference
product.
Microbiological Attributes Firm has submitted the preservative efficacy
Formulation contain preservative, so report of boric acid which has similar results as
preservative effectiveness studies to be that of benzalkonium chloride report.
performed as per recommendations of Further, how the firm performed preservative
pharmacopoeia and shall be submit. efficacy test prior the manufacturing of stability
batches, as the stability batches were
manufactured in the month of feb,2020, while the
batch used for preservative test was
jan,2020.
Control of Drug Product Firm has not submitted the analytical procedure
Analytical procedures used for quality test of drug product.
Provided assay procedure is of diclofenac
sodium injection as evident from the
documents and only acceptance criteria of
pH, sterility test and identification test has
been given instead of detailed analytical
procedure. Provide detailed analytical
procedure used for testing of applied
product i.e. diclofenac sodium ophthalmic
solution.
Validation of analytical procedures Firm has submitted the analytical method
Validation of assay procedure of diclofenac validation studies of drug product but the detailed
sodium injection has been performed as assay procedure including chromatographic
evident from the submitted documents. condition has not been provided.
Provide validation study of analytical
method of diclofenac ophthalmic solution.
Reference Standards or Materials Firm has not submitted COA of reference
COA of raw material of Diclofenac sodium standard against which quality of product has
(Bromine free) BP2010 has been attached in been tested.
3.2.P.6 instead of COA of
reference/working standard.
Stability Firm not submitted any response regarding both
Provide raw data sheet reflecting the of these shortcomings.
method of preparation of standard solution,
sample solution, formula for calculation of
assay content, calculation for determination
of water loss content.
How percentage of water loss has been
calculated at zero time point during stability
studies. Provide the detail calculation
performed to obtained the water loss using
the factor 3 and 1.8 at the initial time point.
stability batches.
not mentioned in all three BMRs
In BMR the range of pH of ophthalmic solution
was 7.5-8.5, while the finished product
specification specify that the pH range of product
should be 6.5-7.5.
Deferred for submission of following:
Clarification regarding how the bulk ophthalmic solution of commercial batches will be sterilized
in the autoclave and provide evidence of availability of large capacity closed glass containers for
autoclaving of commercial batches and autoclave of large capacity.
Scientific justification for using an entirely different formula for calculation of assay results of
stability batches from that specified in USP monograph and rationale of the results reported on
basis of this calculation formula.
Scientific justification for variation in the sample & standard solution preparation method from that
specified in the USP monograph.
Submission of detailed analytical procedure of drug product as per BP monograph.
Submission of drug excipient compatibility studies as the qualitative composition of the
formulation is not similar to innovator / reference product.
Scientific justification for submitting same data of preservative efficacy test for benzalkonium and
boric acid.
Justification for performing preservative efficacy test prior to manufacturing of stability batches.
Scientific justification for submitting same water loss study data in all the applied ophthalmic
solution products.
Provide raw data sheets reflecting the method of preparation of standard solution, sample solution,
formula for calculation of assay content, calculation for determination of water loss content.
Scientific justification for using overage of diclofenac sodium in the formulation.
Clarification regarding the variation of pH range observed in BMR from that specified in drug
product specifications.
Response of the Firm:
Sr.no Decision of 316th meeting of Reply of the Firm
. Registration Board
1. Justify, how the bulk ophthalmic Firm claimed that they sterilized the container in
solution of commercial batches will which the bulk solution will be prepared prior
be sterilized in the autoclave, and manufacturing of bulk solution, further the bulk
provide evidence of availability of solution will be filter through 0.2µ filter paper
large capacity closed glass and then the filling procedure will be done under
containers for autoclaving of aseptic condition.
commercial batches and autoclave Terminal sterilization of ophthalmic solution will
of such large capacity. not be done because the primary container of
ophthalmic solution is LDPE bottle.
2. Scientific justification for using an Firm submitted the revised assay testing
entirely different formula for procedure of drug substance in accordance with
calculation of assay results of BP monograph of Diclofenac Sodium along with
stability batches from that specified clarification that the drug substance used is of BP
in USP monograph and rationale of grade.
the results reported on basis of this
calculation formula.
3. Scientific justification for variation Firm submitted the revised assay testing
in the sample & standard solution procedure of drug substance in accordance with
preparation method from that BP monograph of Diclofenac Sodium along with
specified in the USP monograph. clarification that the drug substance used is of BP
grade.
4. Submission of detailed analytical Submitted
procedure of drug substance as per
BP monograph.
5. Submission of drug excipient Firm in their reply claimed that there the
compatibility studies as the qualitative composition of both test product and
qualitative composition of the innovator product is same therefore API-
formulation is not similar to Excipient compatibility is not required.
6. Scientific justification for Firm submitted the revised preservative efficacy
submitting same data of preservative test report of all three trial batches, which is again
efficacy test for benzalkonium and performed prior manufacturing of each trial
boric acid. batches:
Justification for performing T-01 T-02 T-03
preservative efficacy test prior to Mfg date: Mfg date: Mfg date:
manufacturing of stability batches. 05-02-2020 06-02-2020 07-02-2020
Performance Performance Performance
of of preservative of
preservative efficacy test in preservative
efficacy test january-2020 efficacy test
in january- in january-
2020 2020
Further the same preservative efficacy test report
has been submitted in all the applied ophthalmic
solution.
7. Scientific justification for using Firm in their reply that it was a typographical
overage of diclofenac sodium in the mistake and correct batch formula is submitted.
formulation.
8. Scientific justification for submitting same water loss study data in all applied
temperature, humidity conditions was same for all preparations, even the preparation
also done on oil base method which leads to same water loss results with changes in
points.”
9. Provide raw data sheets reflecting Submitted
the method of preparation of
standard solution, sample solution,
formula for calculation of assay
content, calculation for
determination of water loss content.
10. Clarification regarding the variation Firm has submitted the correct/revised copy of
of pH range observed in BMR from BMR without any clarification, in which
that specified in drug product acceptable range of pH is between 6.5-7.5.
specifications.
Decision: Approved.
Registration letter will be issued after submission of following documents:
• Fee of Rs. 7500/- for correction/pre-approval change in product specifications of each
strength as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
• Preservative efficacy studies, performed in accordance with general chapter of
Pharmacopeias, performance of updated water loss studies and Pharmaceutical
equivalence studies against the innovator/reference product.
297. Name, address of Applicant / M/s Jawa Pharmaceuticals Private Limited112/10
Lahore
☐ Importer
Dy. No. and date of submission Dy.no.13400 dated 18/05/2021
Tbrix 0.3% Ophthalmic Solution
brand name
Active Pharmaceutical ingredient Tobramycin …. 3mg (0.3%)
(API) per unit
Pharmaceutical form of applied drug Clear colorless solution for Ophthalmic use only
Pharmacotherapeutic Group of (API) Aminoglycosides
USP
specifications
Tobrex eye drops 0.3% Alcon USFDA Approved
authorities
For generic drugs (me-too status) Tobrex 0.3% Reg# 008249 Novartis Pharma Ltd
manufacturer Years
Name and address of API M/s Livzon New North River Pharmaceuticals Co.
manufacturer. Ltd
Guangdong China
Module III (Drug Substance) Official monograph of Tobramycin is present in
drug substance.
months
Using factor as per ICH guidelines
against the brand leader that is Tobrex 0.3% by
Novartis Pharma Ltd by performing quality tests
(Identification, pH Assay)
Manufacturer of API M/s Livzon New North River Pharmaceuticals Co. Ltd
Guangdong China
API Lot No. TB-19005
1 x 1`s

Real Time: 0, 3, 6 ,9, 12, 18, 24 (Months)
bottles)
No. of Batches 03
2. Approval of API/ DML/GMP GMP inspection report of M/s. Livzon New North
certificate of API manufacturer issued River Pharmaceuticals (Co.) Ltd. Guangdong China
by concerned regulatory authority of Certificate No.20190944 valid uptill 31/01/2024.
country of origin.
3. Documents for the procurement of Copy of Letter No.5337/2020/DRAP-AD-CD(I&E)
API with approval from DRAP (in dated 20/01/2020 submitted
case of import).
sheets etc.
on product testing
accelerated)
Approval of manufacturing facility of API by Firm has submitted the Valid Good
regulatory body of country and validity. Manufacturing Practice (GMP) certificate of the
Provide Valid Good Manufacturing Practice Drug Substance manufacturer issued by relevant
(GMP) certificate of the Drug Substance regulatory authority of country of origin.
Control of Drug Substance Firm has submitted the copies of the Drug
3.2S.4.2: Analytical procedures substance specifications and analytical
Provide detailed analytical procedures for the procedures used for routine testing of the Drug
testing of drug substance. substance with the claimed that they followed
USP specification.
3.2S.4.3: Validation of analytical procedures Firm has submitted the method verification
Provide analytical Method Verification studies of drug substance performed by the drug
studies including specificity, accuracy and product manufacturer.
repeatability performed by the Drug Product However, the assay method verification studies
manufacturer. did not include the system suitability
determination which is the part of assay in USP.
Specificity parameter has not been performed as
per international guidelines
Recovered active content obtained in Accuracy
parameter is in percentage, while the formula
given in USP monograph is for Calculate the
quantity, in μg/mg, of tobramycin. Firm did not
submit the raw data sheets which reflect the
preparation of solutions.
Batch analysis Firm has not submitted the results of analysis of
Provide results of analysis of relevant relevant batches of Drug Substance performed
batches of Drug Substance performed by by Drug Product manufacturer used during
Drug Product manufacturer used during product development and stability studies, along
product development and stability studies, with Certificate of Analysis (CoA) of the same
along with Certificate of Analysis (CoA) of batch from Drug Substance manufacture.
the same batch from Drug Substance
manufacture.
Microbiological Attributes Firm has not submitted preservative efficacy
Formulation contain preservative, so report.
preservative effectiveness studies to be
performed as per recommendations of
pharmacopoeia and shall be submit.
verification studies of drug product without
Justification of performing specificity submitting the raw data sheets and
parameter without determining chromatogram.
placebo/diluent to demonstrate the absence One-page raw data sheet submitted by the firm
of interference with the elution of analyte. reflects that the preparation of solutions for
According to ICH Q2 R1 guidelines for verification of assay method was not as per USP.
repeatability a minimum of 9 determinations
covering the specified range for the
procedure (e.g., 3 concentrations/3 replicates
each); or a minimum of 6 determinations at
100% of the test concentration are used.
Justification is required for using five
determinants along with provide the detail of
concentration of test sample used to assessed
the repeatability parameter.
accuracy parameter:
Concentration range of sample solution used
to determine the percentage recovery
Batch analysis Firm has not provided any justification for not
Justification for not performing osmolality performing the test of osmolality and osmolarity
and osmolarity test of ophthalmic solution is at the time of batch release, as the said test is the
required. part of USP monograph and the critical attributes
for ophthalmic solutions.
Reference Standards or Materials Firm has submitted an undertaking which stated
Re-standardization date on the submitted that the firm has purchased new working
COA of working standard was 04-09-2020 standard TB-1090613 and claimed that they
while the stability study of drug product was submitted raw data sheets reflecting that the new
continued till 21-12-2020 as per the date working standard has been used for testing of
mentioned on chromatograms. So, the drug product. But the raw data sheets are not
documented evidence is required that either being submitted by the firm.
the standardization of working standard has
been performed before the due date.
Stability Firm has submitted the table of water loss study
Provide raw data sheet reflecting the method of all three stability batches but the values
of preparation of standard solution, sample specified in the said table is different from the
solution, formula for calculation of assay values of water loss initially submitted in the
content, calculation for determination of stability data and the values mentioned in the
water loss content. water loss study submitted in section 3.2. P.2.4.
How percentage of water loss has been
calculated at zero-time point during stability Firm has not provided any justification regarding
studies. Provide the detail calculation the same data of water loss study of all the
performed to obtained the water loss using applied ophthalmic solutions.
Water loss study performed for LDPE
container as per the Asian Guidelines on
stability study of drug product under the
recommended condition of temperature and
humidity i.e. 40℃/25% (factor 3.0) and
30℃/35% (factor 1.8) have same results of %
water loss for all the applied ophthalmic
solution, justification/clarification is required
in the regard.
stability batches.
Bulk solution is autoclaved in closed Glass
container before filing because ophthalmic
solutions are filled in LDPE vials which cannot
be sterilized by terminal sterilization.
Sterilization by Filtration is also done by 0.2µm
and 0.45µm filters. LDPE plastic vials for
ophthalmic solution filling are received as
sterilized.
Not every Solution is sterilized by autoclave
before filling.
Evidence of availability of large capacity closed
glass containers for autoclaving of commercial
batches and autoclave of large capacity.
not mentioned in all three BMRs.
pH of the solution was adjusted by using 1N
HCl. Quantity of 1N HCl solution used for
adjusting pH of the solution was 1.0ml
th
Justification for not performing the verification studies of drug substance in accordance with
relevant guidelines. Further, the verified method did not include the system suitability studies.
Justify, how the bulk ophthalmic solution of commercial batches will be sterilized in the autoclave,
and provide evidence of availability of large capacity closed glass containers for autoclaving of
commercial batches and autoclave of large capacity.
Provide batch analysis report of drug substance performed by drug product manufacturer, for
relevant batch used in the production of drug product stability batches.
Preservative efficacy test data as the formulation contains preservative.
Scientific justification for submitting same water loss study data in all the applied ophthalmic
solution products.
Raw data sheets reflecting the method of preparation of standard solution, sample solution, formula
for calculation of assay content, calculation for determination of water loss content.
Scientific justification for not performing osmolality and osmolarity test of ophthalmic solution at
the time of batch release, despite the test is included in the USP monograph.
Sr. Decision of 316th meeting of Reply of the Firm
no. Registration Board
1. Justify, how the bulk ophthalmic Firm claimed that they sterilized the container in
solution of commercial batches will which the bulk solution will be prepared prior
be sterilized in the autoclave, and manufacturing of bulk solution, further the bulk
provide evidence of availability of solution will be filter through 0.2µ filter paper and
large capacity closed glass then the filling procedure will be done under aseptic
containers for autoclaving of condition.
commercial batches and autoclave Terminal sterilization of ophthalmic solution will
of such large capacity. not be done because the primary container of
ophthalmic solution is LDPE bottle.
2. Justification for not performing the In the reply firm has submitted the verification report
verification studies of drug of drug product instead of drug substance.
substance in accordance with
relevant guidelines. Further, the
verified method did not include the
system suitability studies.
3. Raw data sheets reflecting the Submitted
method of preparation of standard
solution, sample solution, formula
for calculation of assay content,
calculation for determination of
water loss content.
4. Provide batch analysis report of Firm submitted the batch analysis report by drug
drug substance performed by drug product manufacturer and COA of API of same
product manufacturer, for relevant batch i.e. batch no. TB-190052
batch used in the production of
drug product stability batches.
5. Scientific justification for submitting same water loss study data in all applied ophthalmic
solution products.
temperature, humidity conditions was same for all preparations, even the preparation also
done on oil base method which leads to same water loss results with changes in points.”
6. Preservative efficacy test data as the formulation contains preservative.
Firm submitted the revised preservative efficacy test report of all three trial batches, which
is again performed prior manufacturing of each trial batches:
T-01 T-02 T-03
24-02-2020 25-02-2020 26-02-2020
Performance of Performance of Performance of preservative
preservative efficacy test preservative efficacy test efficacy test in january-2020
in january-2020 in january-2020
Further the same preservative efficacy test report has been submitted in all the applied
ophthalmic solution.
Decision: Approved.
specifications of each strength as per notification No.F.7-11/2012-B&A/DRAP dated 07-
05-2021.
• Registration letter will be issued after submission of analytical method verification report
of drug substance by drug product manufacturer, preservative efficacy test report
performed in accordance with general guidance chapter of Pharmacoepias and
performance report of revised water loss study.
298. Name, address of Applicant / M/s Jawa Pharmaceuticals Private Limited
Marketing Authorization Holder 112/10 Quaid e Azam Industrial Area Kot Lakhpat
Lahore
Lahore
☐ Importer
Mox-Q 0.5% Ophthalmic solution
brand name
Active Pharmaceutical ingredient Moxifloxacin HCL e.q. to Moxifloxacin … 5mg
(API) per unit (0.5%)
Pharmaceutical form of applied drug Clear and light-yellow solution for Ophthalmic use
only
Pharmacotherapeutic Group of (API) Quinolone Anti-infective
USP
specifications
Vigamox 0.5% eye drops Alcon USFDA Approved
authorities
For generic drugs (me-too status) Vigamox 0.5% eye drops Reg # 039897
Novartis Pharma Ltd
manufacturer Years Ophthalmic section approved.
Name and address of API M/s Mankind Pharma Ltd New Delhi India 110020
manufacturer. Shree Jee Laboratories Pvt Ltd.
Module III (Drug Substance) Official monograph of Moxifloxacin is present in
drug substance.
months
against the brand leader that is Vigamox 0.1% eye
drops by Novartis Pharma Ltd by performing quality
tests (Identification, pH and Assay)
Manufacturer of API M/s Mankind Pharma Ltd
New Delhi India 110020
Shree Jee Laboratories Pvt Ltd.
1 x 1`s
Used factor as per ICH Guidelines
Real Time: 0, 3, 6 ,9, 12, 18, 24 (Months)
bottles)
No. of Batches 03
2. Approval of API/ DML/GMP Copy of GMP certificate No. DC-I/A-
certificate of API manufacturer issued I/WHO/GMP/2019/203 issued by Drug Controller
by concerned regulatory authority of Rajasthan, Jaipur valid till 26/01/2022.
country of origin.
3. Documents for the procurement of Copy of Letter No. 1936/2020/DRAP-AD-CD(I&E)
API with approval from DRAP (in dated 31/01/2020 submitted
case of import).

sheets etc.
5. Compliance Record of HPLC Complied
on product testing
accelerated)
Ophthalmic general section has not been Firm has submitted the grant of additional section
mentioned in CGMP certificate issued dated letter specified that firm has ophthalmic (general)
06-07-2020 and in Renewal letter of Drug section issued dated 25, June,2019 vide letter no.
manufacturing License issued dated 17th F.1-38/91-Lic (Vol-I).
Manufacture Firm has not submitted any document which
According to the submitted documents clarify the licensing status of Mankind Pharma in
Mankind Pharma Limited 208, Okhla Ind. the country of origin.
Estate, Phase-3, Delhi is the license holder
and Manufacturing site is Shree Jee
Laboratory Private Limited (A subsidiary of
Mankind Pharma Limited) C-24 &25, Riico
Industrial Area, Sotanala, Behror Rajasthan.
Provide the licensing status of Mankind
Pharma issued by relevant regulatory
Control of Drug Substance Firm has submitted the analytical procedure for
3.2S.4.2: Analytical procedures testing of drug substance according to USP
Provide detailed analytical procedures for monograph of moxifloxacin hydrochloride.
the testing of drug substance.
3.2S.4.3: Validation of analytical Firm has submitted the method verification
procedures studies of drug substance performed by the drug
Provide analytical Method Verification product manufacturer.
studies including specificity, accuracy and However, the solution preparation methods are
repeatability performed by the Drug not in accordance with USP, as in the USP
Product manufacturer. specific diluent has been used for the preparation
sample and standard solution while firm used
distilled water for the preparation of both
solutions.
3.2.P.2: provide preservative efficacy test as Firm has submitted the preservative efficacy
the boric acid has been used as preservative report of Benzalkonium chloride instead of boric
in ophthalmic solution. acid.
Control of Drug Product Firm has submitted the analytical procedure for
Analytical procedure for the determination the determination of pH, sterility and bacterial
of pH, sterility and bacterial endotoxin limit endotoxin limit and osmolality/osmolarity of drug
and osmolality/osmolarity of ophthalmic product.
solution has not been provided.
Batch analysis Firm has not provided any justification for not
Justification for not performing osmolality performing the test of osmolality and osmolarity
and osmolarity test of ophthalmic solution at the time of batch release, as the said test is the
is required. part of USP monograph and the critical attributes
for ophthalmic solutions.
Justification of performing specificity verification studies of drug product which is also
parameter without determining not in accordane with USP monograph in terms of
placebo/diluent to demonstrate the absence method of preparation of solutions (sample and
of interference with the elution of analyte. standard solutions).
According to ICH Q2 R1 guidelines for Further, firm has not provided any justification for
repeatability a minimum of 9 run time of 3min instead of 42 min as
determinations covering the specified range recommended by the USP.
for the procedure (e.g., 3 concentrations/3
replicates each); or a minimum of 6
determinations at 100% of the test
concentration are used. Justification is
required for using five determinants along
with provide the detail of concentration of
test sample used to assessed the
repeatability parameter.
accuracy parameter:
Concentration range of sample solution
used to determine the percentage recovery
Run time of HPLC should be of 42 min as
per the USP monograph of moxifloxacin
while the chromatogram provided along
with the dossier shows that the run time was
3min, justification is required in this regard.
Reference Standards or Material Firm has submitted the COA of working standard
The submitted COA reflects that the product of compendial reference European pharmacopeia,
is API of Moxifloxacin Hydrochloride since the drug product is of USP specification.
instead of primary or secondary reference
standard. Clarification is required in this
regard.
Stability Firm has submitted revised stability study data of
Provide raw data sheet reflecting the 3 batches of drug product at both accelerated as
method of preparation of standard solution, well as real time conditions.
sample solution, formula for calculation of Revised stability study shows that at zero time
assay content, calculation for determination point percentage water loss is 0% and result of
of water loss content. osmolarity has been included in the stability data
How percentage of water loss has been sheet.
calculated at zero time point during stability
studies. Provide the detail calculation Firm has not submitted the raw data sheet
performed to obtained the water loss using reflecting the method of preparation of standard
the factor 3 and 1.8 at the initial time point. solution, sample solution, formula for calculation
Water loss study performed for LDPE of assay content, calculation for determination of
container as per the Asian Guidelines on water loss content.
stability study of drug product under the Firm has not provided any justification regarding
recommended condition of temperature and the same data of water loss study of all the applied
humidity i.e. 40℃/25% (factor 3.0) and ophthalmic solutions.
30℃/35% (factor 1.8) have same results of
% water loss for all the applied ophthalmic
solution, justification/clarification is
required in the regard.
Executed Production Documents: Firm has submitted copy of BMR of three stability
Provide copy of Batch Manufacturing batches. However, the following discrepancies
Record (BMR) for all the batches of drug has been observed in the submitted BMR:
product for which stability studies data is According to the BMR, glass container has been
provided in Module 3 section 3.2. P.8.3. sterilized in the autoclave, while the drug product
is packed in LDPE bottles.
How much volume of HCL/NaOH has been used
for the adjustment of pH of the ophthalmic
solution was not mentioned in all three BMRs.
th
Justification regarding how the bulk ophthalmic solution of commercial batches will be sterilized
in the autoclave, and provide evidence of availability of large capacity closed glass containers for
autoclaving of commercial batches and autoclave of large capacity.
Submission of drug-excipient compatibility studies as the qualitative composition of the
formulation is not similar to innovator / reference product.
Justification for submitting the preservative efficacy test of benzalkonium instead of boric acid.
Justification for performing preservative efficacy test prior to manufacturing of stability batches.
Scientific justification for submitting the same water loss study data in all the applied ophthalmic
solution products.
Provide raw data sheets reflecting the method of preparation of standard solution, sample solution,
Scientific justification for applying an entirely different formula for calculation of assay results in
verification studies from that specified in USP monograph and rationale of the results reported on
basis of this calculation formula
Scientific justification for variation in the sample & standard solution preparation method applied
in verification studies, from that specified in the USP monograph.
Reply of the Firm
Sr. Decision of 316th meeting of Registration Board Reply of the Firm
no.
2. Submission of drug-excipient compatibility Firm in their reply stated that excipient
studies as the qualitative composition of the do not show any interaction with the
formulation is not similar to innovator / API which was evident from the
reference product. stability data in which all the
specifications of drug product were
within limit.
3. Raw data sheets reflecting the method of Submitted
preparation of standard solution, sample
solution, formula for calculation of assay
content, calculation for determination of water
loss content.
4. Scientific justification for applying an entirely Firm submitted the revised analytical
different formula for calculation of assay results procedure of drug product which is in
in verification studies from that specified in USP accordance with USP monograph of
monograph and rationale of the results reported moxifloxacin ophthalmic solution.
on basis of this calculation formula
5. Scientific justification for variation in the Firm submitted the revised analytical
sample & standard solution preparation method procedure of drug product which is in
applied in verification studies, from that accordance with USP monograph of
specified in the USP monograph. moxifloxacin ophthalmic solution.
6. Scientific justification for not performing Firm has not submitted the reply of this
osmolality and osmolarity test of ophthalmic observation.
solution at the time of batch release, despite the
test is included in the USP monograph.
7. Provide batch analysis report of drug substance Firm submitted the batch analysis
performed by drug product manufacturer, for report by drug product manufacturer
relevant batch used in the production of drug and COA of API of same batch i.e.
product stability batches. batch no. TB-190052
solution products.
temperature, humidity conditions was same for all preparations, even the preparation also
done on oil base method which leads to same water loss results with changes in points.”
T-01 T-02 T-03
24-02-2020 25-02-2020 26-02-2020
Performance of Performance of Performance of preservative
preservative efficacy preservative efficacy test in january-2020
test in january-2020 efficacy test in
january-2020
Decision: Approved.
• Registration letter will be issued after submission of performance of next time point
of long term stability studies as per USP monograph, Pharmaceutical equivalence
studies performed against the innovator/reference/comparator product, preservative
efficacy test performed in accordance with general guidance chapter of
Pharmacoepias and updated water loss study alongwith fee of Rs. 7500/- for
correction/pre-approval change in product specifications as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021.
299. Name, address of Applicant / M/s Jawa Pharmaceuticals Private Limited
Marketing Authorization Holder 112/10 Quaid e Azam Industrial Area Kot Lakhpat
Lahore
Lahore
☐ Importer
Details of fee submitted PKR 20,000/-: dated 19/10/2020 slip no.2031168
Jentacin 0.3% Ophthalmic solution
brand name
Active Pharmaceutical ingredient Gentamicin (as Sulphate) …… 3mg (0.3%)
(API) per unit
Pharmaceutical form of applied drug Clear slightly yellow color solution for Ophthalmic
use only
Pharmacotherapeutic Group of (API) Aminoglycosides anti-infective
USP
specifications
The status in reference regulatory Genoptic 0.3% Ophthalmic solution
authorities Allegan Australia Pvt Ltd
For generic drugs (me-too status) Optagen 0.3% eye drops
Reg # 011261
Remington Pharma
manufacturer Years
Name and address of API Fuan Pharmaceuticals Group, Yantai Justaware
manufacturer. Pharmaceutical Co. Ltd
Module III (Drug Substance) Official monograph of Gentamicin is present in
drug substance.
months
against the brand leader that is Optagen 0.3% eye
drops by Remington Pharmaceuticals by performing
quality tests (Identification, pH and Assay)
Manufacturer of API Fuan Pharmaceuticals Group, Yantai Justaware Pharmaceutical Co. Ltd
API Lot No. 181211016
Description of Pack White opaque LDPE bottle with polypropylene nozzle and high-density
(Container closure polyethylene (HDPE) cap.
system) 1 x 1`s
Real Time: 0, 3, 6 ,9, 12 (Months)
Batch Size 3L (600 bottles) 3L (600 bottles) 3L (600 bottles)
No. of Batches 03
2. Approval of API/ DML/GMP GMP certificate No. SD20190963 issued by CFDA
certificate of API manufacturer issued valid till 16.07.2024
country of origin.
3. Documents for the procurement of • Already Registered Product
API with approval from DRAP (in • Copy of letter No.8822/2019/DRAP-AD-
case of import). CD(I&E) dated 07/07/2020
sheets etc.
on product testing
accelerated)
Approval of manufacturing facility of API by Firm submitted the GMP certificate of M/s.
regulatory body of country and validity. Fuan Pharmaceutical Group Yantai Justaware
Provide Valid Good Manufacturing Practice Pharmaceutical Co. Ltd. valid till 16-07-2024.
(GMP) certificate of the Drug Substance
Provide copy of Batch Manufacturing Record Firm submitted the Batch manufacturing
(BMR) for all the batches of drug product for record which reflects that the filling of
which stability studies data is provided in Module ophthalmic solution has been performed under
3 section 3.2. P.8.3. aseptic condition and prior filling ophthalmic
solution has filtered through 0.2µm filter.
But the BMR did not reflect the salt
adjustment calculation of Gentamicin
sulphate.
• Provide detailed analytical procedures for the Firm submitted the analytical procedure and
testing of drug substance. verification studies of drug substance
• Provide analytical Method Verification performed by drug product manufacturer.
studies including specificity, accuracy and
repeatability performed by the Drug Product
manufacturer.
Provide results of analysis of relevant batches of Firm submit the batch analysis report of drug
Drug Substance performed by Drug Product substance batch no. 181211016.
manufacturer used during product development
and stability studies, along with Certificate of
Analysis (CoA) of the same batch from Drug
Substance manufacture.
Provide compatibility studies of the Drug Firm submitted the formulation optimization
Substance(s) with excipients as the qualitative study instead compatibility studies with
composition of the formulation is not similar to excipient.
Formulation contain preservative, so preservative Firm has submitted the preservative efficacy
effectiveness studies to be performed as per studies data.
recommendations of pharmacopoeia and shall be But how the firm performed preservative
submit. efficacy test prior the manufacturing of
stability batches, as the stability batches were
manufactured in the month of feb,2020, while
the batch used for preservative test was
jan,2020.
Further, the test results of all the recent applied
ophthalmic solution are similar.
You have claimed USP specifications for the drug Firm replied that our drug substance complied
product and have used drug substance complying with BP specifications and we had chosen
BP specifications. Justification is required in this USP for our product. USP specifications
regard. define a wide range of assay percentage (90-
135%) with comparison to BP (90-120%). It
allowed us to lock an accurate formulation for
safety of the product.
Submit detailed microbial assay procedure for Firm submitted the microbiological assay
quantification of content of gentamicin as per procedure of drug product which is not in
USP along with detail of media, inoculum, accordance with USP <81>.
sample preparation procedure of standard and test
solution, concentration of median solution,
incubation temperature and duration and
calculation of potency.
Submitted verification report reflects that the Firm submitted the verification studies of
verification studies have been done on microbial assay which is not in accordance
identification method while as per the CTD with USP.
guidance document “officially recognized
compendial methods for assay are required to be
verified and verification shall include a
demonstration of specificity, repeatability
(method precision) and accuracy”.
Reference Standards or Materials Firm submitted the COA of working standard
Submit COA of primary / secondary reference supplied by API manufacturer, Batch
standard including source and lot number, since no.181217266.
the submitted COA is of raw material of
gentamicin sulphate
Stability Firm submitted the one pager raw data sheet
• Provide raw data sheet reflecting the method reflect only the procedure along with
of preparation of standard solution, sample calculation formula which is also not in
solution, formula for calculation of assay accordance with USP.
content, calculation for determination of
water loss content. Firm submitted the revised stability data sheet
• How percentage of water loss has been which shows that at zero-time point water loss
calculated at zero-time point during stability has not occurred.
studies, provide the detail calculation
performed to obtained the water loss using
• As per the submitted stability data sheet,
stability has been performed at 30°C ± 2°C / Firm submitted the revised data logger record
65% ± 5%RH and 40°C ± 2°C / 75% ± which reflects that temperature and humidity
5%RH, while data logger record reflects the maintained at 30°C ± 2°C / 65% ± 5%RH and
maintenance of temperature and humidity at 40°C ± 2°C / 75% ± 5%RH.
40℃/25% and 30℃/35%. Justification is
Decision of 316th meeting of Registration Board
Deferred for the submission of following:
• Clarification regarding the sterilization method of ophthalmic solution with respect to the
BMR, whether the filling has been done under aseptic condition or the bulk solution was
sterilized in autoclave.
• Drug-excipient compatibility studies as the qualitative composition of the formulation is not
similar to innovator / reference product.
• Justification is required for applying different microbial assay procedure for analysis of both
drug substance and drug product from that specified in relevant USP monograph.
• Justification for submitting the preservative efficacy test for benzalkonium instead of boric
acid.
• Justification for performing preservative efficacy test prior to manufacturing of stability
batches.
• Scientific justification for submitting the same water loss study data in all the applied
• Raw data sheets reflecting the method of preparation of standard solution, sample solution,
• Differential fee of Rs. 10,000/- as the application for registration had been submitted after the
Reply of the Firm:
Sr. Decision of 316th meeting of Registration Reply of the Firm
no. Board
2. Submission of drug-excipient compatibility Firm in their reply stated that excipient
studies as the qualitative composition of the do not show any interaction with the API
formulation is not similar to innovator / which was evident from the stability data
reference product. in which all the specifications of drug
product were within limit.
3. Justification is required for applying different Submitted only the analytical procedure
microbial assay procedure for analysis of both in accordance with USP. Analytical
drug substance and drug product from that method verification needs to be
specified in relevant USP monograph. submitted.
4. Raw data sheets reflecting the method of Firm submitted the raw data sheets.
preparation of standard solution, sample
solution, formula for calculation of assay
content, calculation for determination of water
loss content.
solution products.
Firm submitted the reply that “We have already provided justification for same water loss
study results (We had purchased LDPE bottles from Pak Nationals Limited which was
used for all ophthalmic preparation’s trial batches of the same batch. The temperature,
humidity conditions was same for all preparations, even the preparation also done on oil
base method which leads to same water loss results with changes in points.”
T-01 T-02 T-03
20-02-2020 21-02-2020 22-02-2020
Performance of preservative Performance of Performance of
efficacy test in january- preservative efficacy test preservative efficacy test
2020 in january-2020 in january-2020
7. Differential fee of Rs. 10,000/- as the application for registration had been submitted after
the notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Firm submitted the differential fee of Rs. 10,000/- DATED 24-05-2022 as the application
for registration had been submitted after the notification No.F.7-11/2012-B&A/DRAP
dated 07-05-2021.
Decision: Approved.
• Registration letter will be issued after submission of performance of next time point
of long term stability studies as per USP monograph, Pharmaceutical equivalence
studies performed against the innovator/reference/comparator product, preservative
efficacy test performed in accordance with general guidance chapter of
Pharmacoepias and updated water loss study alongwith fee of Rs. 7500/- for
correction/pre-approval change in product specifications as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021.
300. Name, Address Of Applicant / M/s Bio-Labs (Pvt). Ltd
Marketing Authorization Holder Plot No. 145industrial Triangle Kahuta road
Islamabad.
Name, address of Manufacturing site. M/s Bio-Labs (Pvt). Ltd
Plot No. 145industrial Triangle Kahuta road
Islamabad.
☐ Importer
Cetol 100ml infusion
brand name
Active Pharmaceutical ingredient Paracetamol ………..10mg
(API) per unit
Pharmaceutical form of applied drug Infusion
Pharmacotherapeutic Group of (API) Analgesic
In-House
specifications
US FDA
authorities
For generic drugs (me-too status) Provas infusion by sami Pharma.
GMP status of the Finished product GMP certificate issued based upon inspection
manufacturer conduct 23-4-2019, valid upto 22-04-2022.
Name and address of API Hebei jiheng (Group) Pharmaceutical Co.,Ltd
manufacturer. Xijingming Village Donganzhuang Township
Shenzhou Country Hengshui City,Hebei
Province,053800 China
Summary) template. Firm has summarized information related
drug product.
Module III (Drug Substance) Firm has submitted detailed data of drug substance
Stability studies Firm has submitted stability study data of 3 batches
of drug substance at both accelerated as well as real
time conditions. The accelerated stability data is
conducted at 40 O ± 2 O C /75% ± 5% RH for 6
months. The real time stability data is conducted at
30OC ± 2 O C / 65% ± 5% RH for 60 months.
(31106015,31106016,31106017)
Module-III (Drug Product): Firm has submitted data of drug product including
comparative dissolution profile equivalence for all the quality tests for their product
against the comparator i.e. Provas 100ml infusion.
Analytical method Firm has submitted report of validation of analytical
validation/verification of product method for the drug product.
Manufacturer of API Hebei jiheng(Group) Pharmaceutical Co., Ltd
Xijingming Village Donganzhuang Township Shenzhou
Country Hengshui City, Hebei Province,053800 China.
API Lot No. W32002004
Description of Pack Glass vial filled with clear colorless sterile solution, with blue
(Container closure system) colored flip-off seal.
Batch No. CET 21 -41 CET 21 -42 CET 21 -43
No. of Batches 03
1. Reference of previous approval of Empaglif 10mg tablet
2. Approval of API/ DML/GMP Firm has submitted copy of GMP Certificate.
country of origin.
3. Documents for the procurement of Firm has submitted copy of Form 6 “License to
API with approval from DRAP (in import drugs for clinical trial, examination, test or
case of import). analysis. The license was issued on 20-03-20 with
Invoice No. 2002ZP26.
sheets etc.
5. Compliance Record of HPLC Firm has submitted audit trail and HPLC CFR
software 21CFR & audit trail reports Compliance record.
on product testing
temperature and humidity monitoring temperature and humidity monitoring of real time
of stability chambers (real time and and accelerated stability chambers.
accelerated)
Evaluation by PEC:
Sr. Observations/Deficiencies/ Short- Reply of the Firm
no. comings
1. Justify why the pharmaceutical Firm in their reply stated that “As that Paracetamol
equivalence was studied against infusion is short in the pharma market due to current
comparator product instead of pandemic situation of COVID-1& Dengue. So,
using innovator / reference product. innovator packs weren’t available in the local
market of Pakistan. That is the reason the
comparative study has been done against local
leading brand”.
2. Submit COA of reference standard The requisite documents regarding reference
actually used in the analysis of drug standard are attached.
substance in section 3.2. S.5.
3. Scientific justification is required In order to avoid degradation, bio-oxidation and to
for not using antioxidant in the purging was done during manufacturing that
applied formulation since the reduces the oxidation and stabilize the formulation.
innovator brand used cysteine as an However the executed BMR did not mentioned any
antioxidant because paracetamol is kind of purging while filling of vials.
susceptible to degradation by
oxidation.
4. Scientific justification is required Osmolarity test has been performed on the finished
for not performing test of formulation, however, as it was additional test to
osmolality while batch release of check the stability of product. So it wasn’t included
trial batches of drug product, since in the final report.
the test has included in drug
product specification of innovator
brand.
Justify the acceptance limit of pH
below 5.5. ,since the innovator
brand describe the pH value of
infusion solution about 5.5.
5. As per the CTD guidance The batch size was design to perform the stability
document the minimum batch size testing as the batch size 250 infusion fulfil the
for injectable should be atleast 2 requirement of samples for stability testing. So this
batches of minimum 2000 batch was selected.
size OR At least 3 batches having
scientifically rational batch size,
sufficient enough to perform
complete testing till the claimed
shelf life, while you have
manufactured three trial batches
with batch size of 250 vial each.
Justify, the batch size of trial
batches in light of guidance
document approved by DRAP.
6. BMR formulation sheet reflect that The injectable grade of Paracetamol has been used
you have used injectable grade in the formulation. However, it wasn’t mentioned on
paracetamol but the COA of API the COA.
did not reveal that the paracetamol
is of injectable grade, clarification
is required in this regard.
Deferred for;
• Justification for the acceptance limit of pH below 5.5 for the applied product, since the
innovator brand describe the pH value of infusion solution about 5.5.
• Submission of finished product specification mentioning Osmolality test.
• Scientific justification is required for not using antioxidant in the applied formulation since
the innovator brand used cysteine as an antioxidant because paracetamol is susceptible to
degradation by oxidation.
Response of the firm:
Sr.no Shortcomings/deficiencies Response of the Firm
.
1. Justification for the acceptance limit Firm replied that Teva PHARMA ,Netherland
of pH below 5.5 for the applied Product have pH between 4.5-7.5 and MHRA
product, since the innovator brand approved product of Fresenius Kabi has set pH
describe the pH value of infusion range between 5-7,so their product pH range
solution about 5.5. i.e. below 5 is well within specified range.
2. Submission of finished product Revised specification of drug product has
specification mentioning Osmolality been submitted by the Firm.
test.
3. Scientific justification is required for Firm claimed that they used same qualitative
not using antioxidant in the applied composition as of MHRA registered product.
formulation since the innovator
brand used cysteine as an antioxidant
because paracetamol is susceptible to
degradation by oxidation.
Decision: Approved.
Registration Board further decided that registration letter will be issued after submission of
clarification that specification of which innovator brand will be adapted for quality testing of
drug product and accordingly submit the performance report of all quality parameters on
next time point of stability.
Previously Deferred cases of Form-5

301. Name and address of The Searle company limited F-39 Site Karachi
manufacturer /Applicant Pakistan.
Brand Name +Dosage Form +
Frutum tablets
Strength
Zinc Oxide eq. to Zinc…..22.5mg
Vitamin A acetate eq. to Vitamin A…..5000IU
Vitamin B1……2.25mg
Vitamin B2……2.6mg
Vitamin B6…….3mg
Vitamin B12…….9mcg
Vitamin C………90mg
Vitamin D……..400IU
Vitamin E Acetate 50% eq. to Vitamin E……30IU
Nicotinamide…….20mg
Composition Biotin…….150mcg
Calcium…..162mg
Phosphorus…….125mg
Copper…..3mg
Folic Acid…..400mcg
Ferrous Fumarate eq. to Iron……18mg
Potassium Iodide eq. to Iodine….150mcg
Magnesium Oxide eq. to Magnesium…..100mg
Manganese Sulphate monohydrate eq.to
Manganese……7.5mg
Calcium-D Pantothenate eq. to Pantothenic Acid..10mg
Potassium Sulphate eq. to Potassium….….7.5mg
Diary No. Date of R& I & fee Dy. No.170; 27-1-2017; Rs.20,000/- (26-1-2017)
Pharmacological Group Vitamin & minerals
Type of Form Form-5
Finished product Specification Inhouse
Pack size & Demanded Price 30’s, As per DPC
Approval status of product in
Reference Provided Reference could not be confirmed.
Regulatory Authorities.
Me-too status Provided Reference could not be confirmed
Last inspection report 30-01-2019, with the conclusion
that the firm for continuous improvement and people
GMP status
met, it is concluded that the firm is operating at a Good
level of GMP compliance.
International Reference in RRA and me-too status
Remarks of the Evaluator. could
not be confirmed.
Registration Board in its 279th meeting decided as
under:
Deferred for following:
• Evidence of approval of applied formulation in
reference regulatory authorities/agencies which were
Previous Decision (279th)
declared/approved by the Registration Board in its 275th
meeting.
• Evidence of applied formulation/drug already
approved by DRAP (generic / me-too status) along with
registration number, brand name and name of firm.
Registration in its 295th meeting decided as under:
Deferred for the evidence of applied formulation/drug
already approved by DRAP (generic / me-too status)
along with registration number, brand name and name
of firm.
Firm submitted revised formulation along with fee of
Rs. 20,000/- dated 05-01-2021 Dy. No. 703, according
to the formulation of Me-Too registered in Pakistan
Theragran Ultra Tablet (Reg.no. 033732) by M/s.
Glaxo Smith Kline Pakistan.
Revised formulation is as under:
Vitamin A ….4000IU
Beta Carotene….1000IU
Vitamin D ….400IU
Vitamin E ….30IU
Vitamin C ….90mg
Vitamin B1….3mg
Previous Decision and Vitamin B2….3.4mg
Response of the firm Vitamin B6….3mg
Vitamin B12….9mcg
Pantothenic Acid….10mg
Folic Acid ….0.4mg
Biotin….30mcg
Niacin ….20mg
Iron ….27mg
Calcium…40mg
Phosphorus ...31mg
Iodine ….150mcg
Magnesium….100mg
Copper….2mg
Zinc….15mg
Manganese ……5mg
Selenium….10mcg
Molybdenum ….15mcg
Chromium….15mcg
Potassium……7.5mg
Chloride ….7.5mg
Decision of 297th meeting of Registration Board
Deferred, as the quantity of Iodine used in the
composition is above upper tolerable intake level (UL).
Previous Decision (297th
Furthermore, clarification/justification is required from
meeting)
M/s. Glaxo smith Kline Pakistan regarding the quantity
of iodine used in the Theragran Ultra Tablet, as it is
above the UL level.
Remarks of the Evaluator M/s. Glaxo Smith Kline Pakistan Ltd. Submitted an
additional pack approval letter dated 19-03-2015
according to that quantity of iodine used in the
Theragran ultra is 150mcg, which is within UL limit and
same quantity has been used in the applied formulation.
Decision: Approved.
302. Name and address of M/s. Kanel Pharmaceuticals, Plot No.6, Road SS-3
manufacturer / Applicant National Industrial Zone, Rawat, Rawalpindi
Brand Name +Dosage Form + Kortel-D DS Tablets
Strength
Diary No. Date of R& I & fee (Original Dossier) Dy. No.7038 dated 13/07/2012
Rs.8,000/-
Differential fee (Original) of Rs.12,000/- submitted on
26/01/2016 Dy.No.570
Composition Each Film coated Tablet contains
Artemether………… 80mg
Lumefantrine ……….480 mg
Pharmacological Group Antimalarial
Type of Form Form 5
Finished Product Specification Manufacturer’s Specification
Pack Size & Demanded Price As per S.R. O
Approval Status of Product in WHO prequalified drug
Reference Regulatory
Authorities
Me-too Status Marlin DS Tablet M/s Jupiter Pharma Plot # 25, St#
S6 RCCI, Rawat Islamabad (Reg.no. 081928)
GMP Status Certificate of GMP issued dated 04th June,2020 vide
certificate no.F.3-52/2020-Addl.Dir. (QA&LT-I) by
QA&LT Division and valid for two years. Following
sections are mentioned on the GMP certificate:
Tablet (General)
Capsule (General)
Cream/Ointment
Topical Lotion
Capsule (Cephalosporin)
Dry Suspension (Cephalosporin)
Dry vial Injection (Cephalosporin)
Remarks of the Evaluator. • Firm applied with manufacturers’ specification
while the official monograph of applied
formulation is present in IP.
• Reference product is uncoated tablet while the
firm applied for film coated tablet.
th
Deferred for revision of applied formulation in line with reference product i.e. uncoated
tablet alongwith submission of requisite fee, revised Form-5, master formulation &
manufacturing method.
Firm submitted the revised formulation in line with reference product i.e. uncoated tablet
alongwith submission of requisite fee (fee of 7,500/- paid vide challan no. 56003611041
dated28-06-2022), revised Form-5, master formulation & manufacturing method.
Decision: Approved. Firm will deposit Rs.30,000/- for revision of applied formulation
in line with reference product.
303. Name and address of M/s. Kanel Pharmaceuticals, Plot No.6, Road SS-3
manufacturer / Applicant National Industrial Zone, Rawat, Rawalpindi
Brand Name +Dosage Form + Kenkast 5mg Tablet
Strength
Diary No. Date of R& I & fee (Original Dossier) Dy. No.7065 dated 13/07/2012
Rs.8,000/-
Differential fee (Original) of Rs.12,000/- submitted on
26/01/2016 Dy.No.571
Montelukast sodium eq to Montelukast
…………………. 5 mg
Pharmacological Group Bronchodilator and antiasthmatic agent
Type of Form Form 5
Finished Product Specification USP Specification
Pack Size & Demanded Price As per S.R. O
Approval Status of Product in SINGULAIR 5-mg Chewable Tablets (USFDA)
Authorities
Me-too Status Trilukas 5mg chewable Tablet, Trillium
Pharmaceuticals, Reg. No. 096678.
GMP Status Certificate of GMP issued dated 04th June,2020 vide
certificate no.F.3-52/2020-Addl.Dir. (QA&LT-I) by
QA&LT Division and valid for two years. Following
sections are mentioned on the GMP certificate:
Tablet (General)
Capsule (General)
Cream/Ointment
Topical Lotion
Capsule (Cephalosporin)
Dry Suspension (Cephalosporin)
Dry vial Injection (Cephalosporin)
Remarks of the Evaluator. • Initially, firm used Methylene chloride as a
coating solvent which is a banned excipient,
later firm submitted revise formulation without
methylene chloride. Requisite fee for pre-
registration variation has not been submitted by
the firm.
• Firm applied with manufacturers’ specification,
later change the specification to USP without
the requisite fee.
• Firm applied for film coated tablet while the
reference product is chewable tablet.
Decision of M-312:
• Provide either evidence of approval of reference product as film coated tablet or
otherwise revision of applied formulation in line with reference product i.e.
chewable tablet alongwith submission of requisite fee, revise Form-5, master
formulation & manufacturing method.
• Change of specification from in-house to USP.
• Revision of formulation in order to remove methylene chloride as a coating solvent.
Firm submitted the revised formulation in line with reference product i.e. chewable tablet
alongwith submission of requisite fee(fee of 7,500/- paid vide challan no. 71459906687
dated28-06-2022), revise Form-5, revise specification, master formulation &
304. Name and address of M/s. Maple Pharmaceuticals (Pvt.) Ltd., 147/23,
manufacturer / Applicant Korangi Industrial Area, Karachi.
Brand Name +Dosage Form+ Skelet tablets 2mg
Strength
Diary No. Date of R& I & fee (Duplicate Dossier) dy.no.Rs.8,000/-(Photocopy) dated
23-2-2011
Differential fee (Yellow slip) Rs.12,000/- submitted on
21-10-2015
Receipt of application has verified from R&I
Tizanidine Hydrochloride....................2mg
Pharmacological Group Skeletal muscle relaxant
Type of Form Form 5
Pack Size & Demanded Price 10’s/ As per PAC/PRC
Approval Status of Product in USFDA approved as uncoated tablets
Authorities
Me-too Status Tizadin 2mg Tablets Global Pharmaceuticals,
Islamabad.
GMP Status Grant of GMP certificate based on inspection
conducted on 20-12-2019 concluded with the remarks
of Good compliance
Remarks of the Evaluator. ▪ Firm revised the master formulation and remove the
overage.
▪ Revision of applied composition as in reference
regulatory authorities the approved drug is
“Tizanidine as HCl”, while the applied drug is
“Tizanidine HCl”.
▪ The official monograph for the applied formulation
is available in USP.
Decision of M-308:
Deferred the case for revision of formulation as the reference product contains Tizanidine
as HCl…2mg while the applied formulation contains Tizanidine HCl…2mg along with
submission of revised Form 5, master formulation and requisite fee.
Firm submit the revised formulation in line with reference product i.e. Tizanidine as
HCl…2mg along with submission of revised Form 5, master formulation and requisite fee(
fee of Rs.7,500/- submitted vide challan no. 2967386323 dated 15-10-2021).
305. Name and address of M/s. Maple Pharmaceuticals (Pvt.) Ltd., 147/23,
manufacturer / Applicant Korangi Industrial Area, Karachi.
Brand Name +Dosage Form+ Skelet tablets 4mg
Strength
Diary No. Date of R& I & fee (Duplicate Dossier) dy.no. Rs. 8,000/-(Photocopy)
dated 23-2-2011
Differential fee (Yellow slip) Rs. 12,000/- submitted on
21-10-2015
Receipt of application has verified from R&I
Tizanidine Hydrochloride....................4mg
Pharmacological Group Skeletal muscle relaxant
Type of Form Form 5
Pack Size & Demanded Price 10’s/ As per PAC/PRC
Approval Status of Product in USFDA approved as uncoated tablets
Authorities
Me-too Status Musidin 4mg Tablet by M/s Martin Dow
GMP Status Grant of GMP certificate based on inspection
conducted on 20-12-2019 concluded with the remarks
of Good compliance
Remarks of the Evaluator. ▪ Firm revised the master formulation and remove the
overage.
▪ Revision of applied composition as in reference
regulatory authorities the approved drug is
“Tizanidine as HCl”, while the applied drug is
“Tizanidine HCl”.
▪ The official monograph for the applied formulation
is available in USP.
Decision of M-308:
Deferred the case for revision of formulation as the reference product contains Tizanidine
as HCl…4mg while the applied formulation contains Tizanidine HCl…4mg along with
submission of revised Form 5, master formulation and requisite fee.
Firm submit the revised formulation in line with reference product i.e. Tizanidine as
HCl…4mg along with submission of revised Form 5, master formulation and requisite fee(
fee of Rs.7,500/- submitted vide challan no. 2638920487 dated 15-10-2021).
Item No. VI: Agenda of Evaluator-V (Mst. Iqra Aftab)
Case No. 01: Registration applications of Local Cases.

Deferred Cases
306. Name and address of manufacturer / "M/s Friends Pharma Pvt Ltd.
Applicant 31-km, Ferozepur Road, Lahore, Pakistan"
Brand Name +Dosage Form + Ketafend Injection 500mg
Strength
Composition "Each 10ml Contains:
Ketamine HCl Eq To Ketamine…500mg
Diary No. Date of R& I & fee Dy.No 13121 dated 06-03-2019 Rs.20,000/- dated 06-
03-2019
Pharmacological Group General anaesthetics
Type of Form Form 5
Pack size & Demanded Price As per SRO, Glass ampoule 10ml.
Approval status of product in USFDA approved in Vial .
Reference Regulatory Authorities.
Me-too status Ketarol of Global
GMP status GMP inspection 08-03-2019
General Liquid section (Vial and Ampoule)
Remarks of the Evaluator V • Revision of master formulation as per innovator is
required i.e. “50 mg ketamine base (equivalent to
57.67 mg ketamine hydrochloride” along with
• Availability of applied product in ampoule.
Evaluation
• Initially, the firm has applied for ampoule now the
firm has changed the container closure system to
vial without submitting relevant documents as per
Form 5.
• Evidence of SVP couldn’t be confirmed from
section letter and panel inspection report.
• Firm has corrected the master formulation with
submission of Rs 7500/- dated 17-03-2022.
Decision of 320th Meeting: Deferred for the following reasons:
• Submission of evidence of approval of SVP section by the Central Licensing Board or
panel inspection report for renewal of DML verifying the section.
• Firm shall submit the full fee of Rs. 30,000/- for correction/pre-approval change in
composition (correction of salt form of the drug substance) and change of container
closure system, as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Submission of evidence of approval of SVP

section by the Central Licensing Board or
panel inspection report for renewal of DML
verifying the section.
Firm shall submit the full fee of Rs. 30,000/- Firm has submitted the full fee Rs. 30,000/-
for correction/pre-approval change in dated 03-11-2022.
composition (correction of salt form of the
drug substance) and change of container
closure system, as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021.
Decision of 322nd meeting: Approved.

307.
Name and address of manufacturer / "M/s Max Pharmaceuticals,Plot # 12, St. No. N-7,
Applicant National Industrial Zone, Rawat, Islamabad"
Brand Name +Dosage Form + Strength Maxibest Capsules 500mg
Composition "Each Capsule Contains:
Azithromycin…500mg"
2018
ATC Code: J01FA10
Type of Form Form 5
Pack size & Demanded Price 1x10’s, As per PRC.
Approval status of product in Reference Could not be confirmed.
Me-too status 071422; Brand Name: Azithromycin 500mg Capsules
Manufacturer Name: Unipharma (Pvt) Ltd.,
The company is working at good level of GMP and
record of raw material was found maintained along with
SOP’s the clearance of API’s for imported sources are
attached as of today. GMP is a continuous process of up
gradation, the firm the advise to continue with up
gradation and purchase the desired equipments are
advised.
Remarks of the Evaluator Evidence of approval of applied formulation in
reference regulatory authorities/agencies which were
declared/ approved by the Registration Board in its
275th meeting.
th
Decision of 295 Meeting: Deferred for evidence of approval of applied formulation in
reference regulatory authorities/agencies which were adopted by the Registration Board in
its 275th meeting.
Firm’s reply: Firm has revised their formulation from Azithromycin Capsule to Azithromycin
Tablet.
Name and address of manufacturer / "M/s Max Pharmaceuticals,Plot # 12, St. No. N-7,
Applicant National Industrial Zone, Rawat, Islamabad"
Brand Name +Dosage Form + Strength Maxibest Tablet 500mg
Composition "Each film coated tablet contains:
Azithromycin…500mg"
Diary No. Date of R& I & fee Dy.No 30822 dated 31-10-2022
Rs.30,000/- 31-10-2022
ATC Code: J01FA10
Type of Form Form 5
Pack size & Demanded Price As per PRC.
Approval status of product in Reference TGA Approved.
Me-too status Registration Number: 067514
Zezot Tablet by M/s Bosch
The company is working at good level of GMP and
record of raw material was found maintained along with
SOP’s the clearance of API’s for imported sources are
attached as of today. GMP is a continuous process of up
gradation, the firm the advise to continue with up
gradation and purchase the desired equipments are
advised.
Decision: Approved.
Case No. 02: Registration applications of CTD Cases.

New Cases
308. Name, address of Applicant / Marketing M/s Genix Pharma (pvt.) Ltd.
Authorization Holder 44-45B Korangi creek road, Karachi.
Name, address of Manufacturing site. M/s Genix Pharma (pvt.) Ltd.
44-45B Korangi creek road, Karachi.
☐ Importer
☐ Export sale
Carlep 200mg Tablet
name
Strength / concentration of drug of Active
Eslicarbazepine acetate……………200mg
Pharmaceutical form of applied drug Oblong, White colored, biconvex core tablet plain
from both sides
Pharmacotherapeutic Group of (API) Anti-epileptic

Inhouse Specification
specifications
Proposed Pack size 10’s, 20’s & 30’s
The status in reference regulatory APTIOM tablets 200mg by Sunovion
authorities Pharmaceuticals Inc. USFDA Approved.
GMP status of the Finished product GMP inspection : 28/10/2019
manufacturer Tablet (General & Psychotropic) section approved.
Name and address of API manufacturer. Ami Lifesciences Pr,t. Limited
Plot No. 8218, ECP channel Road
At & post Karakhadi, Dist. Vadodara -391 450
State Gujarat, INDIA
Phone: +9 | -2662-27 3 40 | I 27 33 12
Fax: * 9l-2662-273401
Batches: (ECA/50030515, ECA/50040515,
ECA/50050515)
Batches: (ECA/50020111, ECA/50030111
ECA/50040111)
product.
comparative dissolution profile against the brand leader that is Aptiom 200mg tablet
by Sunovion Pharmaceuticals Inc.by performing
quality tests (Appearance, Identification, DT ,Assay,
Dissolution).
is Aptiom 200mg tablet by Sunovion Pharmaceuticals
Inc in 0.1N HCL, Acetate buffer 4.5 and Buffer (pH
6.8). The values for f2 are in the acceptable range.
of product linearity & Range, robustness, accuracy, precision,
specificity.
Manufacturer of API Ami Lifesciences Pr,t. Limited
API Lot No. ECA/50010117
Description of Pack Alu-Alu blister packed in unit carton (10’s, 20’s & 30’s)
Frequency Accelerated: 1,2,3,4 & 6 (months)
Batch No. 19SB-159-01 19SB-160-02 19SB-161-03
No. of Batches 03
1. Reference of previous approval of A Panel Inspection for the verification of authenticity
applications with stability study data of the of Stability Data of product on Form-5D “Wymly
firm (if any) Tablet 25mg” for Tablet Section has been conducted
on 06 April, 2018. Inspection Report included in the
281th DRB meeting held on 11-13th April, 2018..
The firm has 21CFR compliant system and adequate
monitoring and control for stability chamber.
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. 19041306 issued by
API manufacturer issued by concerned FOOD AND DRUG CONTROL
regulatory authority of country of origin. ADMINISTRATION valid till 24/04/2022.
3. Documents for the procurement of API • Form 6 Dated:27/04/2017 is submitted, wherein

with approval from DRAP (in case of the permission to import API Eslicarbazepine
import). acetate for the purpose of test/analysis and stability
studies is granted.
• Invoice No & Date: EXP/A/007/2017-18 dated
13/04/2017.
• Batch No:ECA/50010117
chromatograms,Raw data sheets, COA,
testing
accelerated)
S. No Sections Observations/Deficiencies/ Reply
Short-comings
1. 1.3.5. Evidence of approval of Firm has provided grant of additional/revised section
relevant section from Tablet (General) – Revised letter dated 30 Sep 2021.
Licensing Authority is
required as you have
provided approval of master
layout plan.
2. 2.3.S.6 The container closure Firm has used food grade LDPE as primary packing
system mentions material of material for drug substance.
construction as food grade
quality material
,clarification is required.
3. 2.3.P.2.2.1 Provide Summary of the The summary of CDP is of Carlep 400mg.
results of comparative
dissolution profile.
4. 2.3.P.3.2 Provide List of all First trail batch of 1000 tablets were manufactured
components of the Drug and parameters found unsatisfactory.
Product to be used in the In order to obtain best and optimized product
manufacturing process and formulation was designed with change in quantitative
their amounts per proposed composition that is Trail 2 in which all physical and
commercial batch as chemical parameters were found satisfactory.
provided data is of Trial As per CTD guidelines three stability batch sizes
batch. Moreover, the batch 1500 Tablet as mentioned in BMR with same
size mentioned in this formulation were manufactured as that of passed trail
section is 1000 tablets and 2.
BMR mentions batch size
of 1500 Tablets. The
quantity of individual
components per tablet
mentioned in Trail batch
formula is different than
stability batch formula.
5. 2.3.P.5.6 Provide justification of Justification for specification not provided only
specifications for all the inhouse has been mentioned.
tests specified in section
2.3.P.5.1.
6. 2.3.R.1.2 Provide blank master BMR has not been signed.
production document /
batch manufacturing record
to be used during the
commercial manufacturing
of the applied product.
7. 3.2.S.4.4 A discussion and Firms Response
justification shall be We follow suppliers COA for residual solvents.
provided for any incomplete
analyses of the drug
substance / API by Drug
Product manufacturer like
residual solvents.
8. 3.2.P.3.3 The maximum holding time Firm has submitted the SOP for withholding time.
for bulk product prior to
final packaging shall be
stated.
9. 3.2.P.5.1 The innovator proposes two Firms Response
point dissolution according We have set our specification single point in 15
to chemistry review. minutes.
10. 3.2.P.5.2 Dissolution testing Firms Response
conducted by test 1 or test 2 USP Type II Paddle apparatus are used.
of USP monograph by Drug
11. 3.2.P.8.3 The formulation was Firms Response
previously applied on Form Provided at the end of 800mg strength.
5 D which was rejected in
289th meeting wherein 7kg
API was imported vide
invoice dated 27-04-2017
and 3kg vide invoice dated
24-02-2017 for
manufacturing of trial
batches of Carlep 200mg,
400mg and 800mg.
Approximately, 6.4 kg was
consumed in manufacturing
of trial batches. Now, you
have applied same
formulation on Form 5 F
wherein the submitted
commercial invoice is same
dated 27-04-2017. Please
justify/clarify the quantity
of API in manufacturing of
current trial batches of
Carlep 200mg, 400mg and
800mg applied on Form-5F.
309. Name, address of Applicant / Marketing M/s Genix Pharma (pvt.) Ltd.
Authorization Holder 44-45B Korangi creek road, Karachi.
Name, address of Manufacturing site. M/s Genix Pharma (pvt.) Ltd.
44-45B Korangi creek road, Karachi.
☐ Importer
☐ Export sale
Carlep 400mg Tablet
name
Eslicarbazepine acetate……………400mg
Oblong shape, white color, biconvex tablet, engraved
‘GENIX” on one side and plain on other side.
Pharmacotherapeutic Group of (API) Anti-epileptic
specifications
The status in reference regulatory APTIOM tablets 400mg by Sunovion Pharmaceuticals
authorities Inc. USFDA Approved.
GMP status of the Finished product GMP granted on 28/10/2019
manufacturer Tablet (General & Psychotropic) section approved.
Name and address of API manufacturer. Ami Lifesciences Pr,t. Limited
Phone: +9 | -2662-27 3 40 | I 27 33 12
Fax: * 9l-2662-273401
solubility’s, physical form, manufacturers, description
Batches: (ECA/50030515, ECA/50040515,
ECA/50050515)
Batches: (ECA/50020111, ECA/50030111
ECA/50040111)
medium) and its verification studies, batch analysis and
product.
comparative dissolution profile against the brand leader that is Aptiom 400mg tablet
by Sunovion Pharmaceuticals Inc.by performing
quality tests (Appearance, Identification, DT ,Assay,
Dissolution).
is Aptiom 200mg tablet by Sunovion Pharmaceuticals
Inc in 0.1N HCL, Acetate buffer 4.5 and Buffer (pH
6.8). The values for f2 are in the acceptable range.
of product linearity & Range, robustness, accuracy, precision,
specificity.
Description of Pack Alu-Alu blister packed in unit carton (10’s, 20’s & 30’s)
Batch No. 19SB-162-01 19SB-163-02 19SB-164-03
No. of Batches 03
1. Reference of previous approval of A Panel Inspection for the verification of authenticity
applications with stability study data of the of Stability Data of product on Form-5D “Wymly
firm (if any) Tablet 25mg” for Tablet Section has been conducted on
06 April, 2018. Inspection Report included in the 281th
DRB meeting held on 11-13th April, 2018..
The firm has 21CFR compliant system and adequate
monitoring and control for stability chamber.
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. 19041306 issued by
API manufacturer issued by concerned FOOD AND DRUG CONTROL
regulatory authority of country of origin. ADMINISTRATION valid till 24/04/2022
3. Documents for the procurement of API • Form 6 Dated:27/04/2017 is submitted, wherein the
with approval from DRAP (in case of permission to import API Eslicarbazepine acetate for
import). the purpose of test/analysis and stability studies is
granted.
• Invoice No & Date: EXP/A/007/2017-18 dated
13/04/2017.
testing
accelerated)
S. No Sections Observations/Deficiencies/ Reply
Short-comings
1. 1.3.5. Evidence of approval of Firm has provided grant of additional/revised section
relevant section from Tablet (General ) – Revised letter dated 30 Sep 2021.
Licensing Authority is
required as you have provided
approval of master layout
plan.
2. 2.3.S.6 The container closure system Firm has used food grade LDPE as primary packing
mentions material of material for drug substance.
construction as food grade
quality material ,clarification
is required.
3. 2.3.P.3.2 Provide List of all First trail batch of 1000 tablets were manufactured and
components of the Drug parameters found unsatisfactory .
Product to be used in the In order to obtain best and optimized product
manufacturing process and formulation was designed with change in quantitative
their amounts per proposed composition that is Trail 2 in which all physical and
commercial batch as provided chemical parameters were found satisfactory.
data is of Trial batch. As per CTD guidelines three stability batch sizes 1500
Moreover, the batch size Tablet as mentioned in BMR with same formulation
mentioned in this section is were manufactured as that of passed trail 2.
1000 tablets and BMR
mentions batch size of 1500
Tablets. The quantity of
individual components per
tablet mentioned in Trail
batch formula is different than
stability batch formula.
4. 2.3.P.5.6 Provide justification of Justification for specification not provided only
specifications for all the tests inhouse has been mentioned.
specified in section 2.3.P.5.1.
5. 2.3.R.1.2 Provide blank master BMR has not been signed.
production document / batch
manufacturing record to be
used during the commercial
manufacturing of the applied
product.
6. 3.2.S.4.4 A discussion and justification Firms Response
shall be provided for any We follow suppliers COA for residual solvents.
incomplete analyses of the
drug substance / API by Drug
Product manufacturer like
residual solvents.
7. 3.2.P.3.3 The maximum holding time Firm has submitted the SOP for withholding time.
for bulk product prior to final
packaging shall be stated.
8. 3.2.P.5.1 The innovator proposes two Firms Response
point dissolution according to We have set our specification single point in 15
chemistry review. minutes.
9. 3.2.P.5.2 Dissolution testing conducted USP Type II Paddle apparatus are used.
by test 1 or test 2 of USP
monograph by Drug product
manufacturer.
10. 3.2.P.8.3 The formulation was Firms Response
previously applied on Form 5 Provided at the end of 800mg strength.
D which was rejected in 289th
meeting wherein 7kg API was
imported vide invoice dated
27-04-2017 and 3kg vide
invoice dated 24-02-2017 for
manufacturing of trial batches
of Carlep 200mg, 400mg and
800mg. Approximately, 6.4
kg was consumed in
manufacturing of trial
batches. Now, you have
applied same formulation on
Form 5 F wherein the
submitted commercial invoice
is same dated 27-04-2017.
Please justify/clarify the
quantity of API in
manufacturing of current trial
batches of Carlep 200mg,
400mg and 800mg applied on
Form-5F.
310. Name, address of Applicant / M/s Genix Pharma (pvt.) Ltd.

Marketing Authorization 44-45B Korangi creek road, Karachi.
Holder
Name, address of M/s Genix Pharma (pvt.) Ltd.
Manufacturing site. 44-45B Korangi creek road, Karachi.
☐ Importer
Carlep 800mg Tablet
/ brand name
Strength / concentration of
drug of Active Pharmaceutical
ingredient (API) per unit Eslicarbazepine acetate……………800mg
Oblong shape, white color, biconvex tablet, engraved ‘GENIX”
drug
on one side and break line on other side.
Anti-epileptic
(API)
specifications
The status in reference APTIOM tablets 800mg by Sunovion Pharmaceuticals Inc.
regulatory authorities USFDA Approved.
Not available
status)
GMP status of the Finished GMP granted on 28/10/2019
product manufacturer Tablet (General & Psychotropic) section approved.
Name and address of API Ami Lifesciences Pr,t. Limited
manufacturer. Plot No. 8218, ECP channel Road
Phone: +9 | -2662-27 3 40 | I 27 33 12
Fax: * 9l-2662-273401
Summary) Summarized information related to nomenclature, structure,
general properties, solubility’s, physical form, manufacturers,
description of manufacturing process and controls, impurities,
specifications, analytical procedures and its verification, batch
analysis and justification of specification, reference standard,
container closure system and stability studies of drug substance
Module III (Drug Substance) The firm as submitted detail of nomenclature, structure, general
properties, solubility’s, physical form, manufacturers, description
of manufacturing process and controls, tests for impurity &
related substances, specifications, analytical procedures and its
verification, batch analysis and justification of specification,
reference standard, container closure system and stability studies
of drug substance
Real time: 30°C ± 2°C / 65% ± 5%RH for 72 months Batches:
(ECA/50030515, ECA/50040515, ECA/50050515)
Batches: (ECA/50020111, ECA/50030111
ECA/50040111)
Module-III (Drug Product): The firm has submitted detail of manufacturers, description of
manufacturing process and controls, impurities, specifications,
analytical procedure (including dissolution testing at acidic and
buffer medium) and its verification studies, batch analysis and
justification of specification, reference standard, container closure
Pharmaceutical equivalence Pharmaceutical Equivalence have been established against the
and comparative dissolution brand leader that is Aptiom 800mg tablet by Sunovion
profile Pharmaceuticals Inc.by performing quality tests (Appearance,
Identification, DT ,Assay, Dissolution).
CDP has been performed against the same brand that is Aptiom
200mg tablet by Sunovion Pharmaceuticals Inc in 0.1N HCL,
Acetate buffer 4.5 and Buffer (pH 6.8). The values for f2 are in
Analytical method Method verification studies have submitted including linearity &
validation/verification of Range, robustness, accuracy, precision, specificity.
product
Description of Pack
Alu-Alu blister packed in unit carton (10’s, 20’s & 30’s)
Batch No. 19SB-166- 19SB-
19SB-165-01
02 167-03
Batch Size 1500 tab 1500 tab 1500
tab
10-09-2019 10-09-2019
2019
No. of Batches 03
7. Reference of previous approval A Panel Inspection for the verification of authenticity of Stability
of applications with stability Data of product on Form-5D “Wymly Tablet 25mg” for Tablet
study data of the firm (if any) Section has been conducted on 06 April, 2018. Inspection Report
included in the 281th DRB meeting held on 11-13th April, 2018..
The firm has 21CFR compliant system and adequate monitoring
and control for stability chamber.
8. Approval of API/ DML/GMP Copy of GMP certificate No. 19041306 issued by FOOD AND
certificate of API manufacturer DRUG CONTROL ADMINISTRATION valid till 24/04/2022
9. Documents for the procurement • Form 6 Dated:27/04/2017 is submitted, wherein the
of API with approval from permission to import API Eslicarbazepine acetate for the
DRAP (in case of import). purpose of test/analysis and stability studies is granted.
• Invoice No & Date: EXP/A/007/2017-18 dated 13/04/2017.
10.
documents like
chromatograms,Raw data
sheets, COA, summary data
sheets etc.
12. Record of Digital data logger Submitted
accelerated)
S. No Sections Observations/Deficiencies/ Short- Reply
comings
1. 1.3.5. Evidence of approval of relevant Firm has provided
section from Licensing Authority is grant of
required as you have provided approval additional/revised
of master layout plan. section
Tablet (General ) –
Revised letter dated 30
Sep 2021.
2. 2.3.S.6 The container closure system mentions Firm has used food
material of construction as food grade grade LDPE as
quality material ,clarification is primary packing
required. material for drug
substance.
3. 2.3.P.3.2 Provide List of all components of the First trail batch of 1000
Drug Product to be used in the tablets were
manufacturing process and their manufactured and
amounts per proposed commercial parameters found
batch as provided data is of Trial batch. unsatisfactory .
Moreover, the batch size mentioned in In order to obtain best
this section is 1000 tablets and BMR and optimized product
mentions batch size of 1500 Tablets. formulation was
The quantity of individual components designed with change
per tablet mentioned in Trail batch in quantitative
formula is different than stability batch composition that is
formula. Trail 2 in which all
physical and chemical
parameters were found
satisfactory.
As per CTD guidelines
three stability batch
sizes 1500 Tablet as
mentioned in BMR
with same formulation
were manufactured as
that of passed trail 2.
4. 2.3.P.5.6 Provide justification of specifications Justification for
for all the tests specified in section specification not
2.3.P.5.1. provided only inhouse
has been mentioned.
5. 2.3.R.1.2 Provide blank master production BMR has not been
document / batch manufacturing signed.
record to be used during the
commercial manufacturing of the
applied product.
6. 3.2.S.4.4 A discussion and justification shall be Firms Response
provided for any incomplete analyses We follow suppliers
of the drug substance / API by Drug COA for residual
Product manufacturer like residual solvents.
solvents.
7. 3.2.P.3.3 The maximum holding time for bulk Firm has submitted the
product prior to final packaging shall SOP for withholding
be stated. time.
8. 3.2.P.5.1 The innovator proposes two point Firms Response
dissolution according to chemistry We have set our
review. specification single
point in 15 minutes.
9. 3.2.P.5.2 Dissolution testing conducted by test 1 USP Type II Paddle
or test 2 of USP monograph by Drug apparatus are used.
10. 3.2.P.8.3 The formulation was previously applied on Form 5 D which was
rejected in 289th meeting wherein 7kg API was imported vide
invoice dated 27-04-2017 and 3kg vide invoice dated 24-02-
2017 for manufacturing of trial batches of Carlep 200mg, 400mg
and 800mg. Approximately, 6.4 kg was consumed in
manufacturing of trial batches. Now, you have applied same
formulation on Form 5 F wherein the submitted commercial
invoice is same dated 27-04-2017. Please justify/clarify the
quantity of API in manufacturing of current trial batches of
Carlep 200mg, 400mg and 800mg applied on Form-5F.
Carlep Tablets Range

Eslicarbazepine Acetate
API Consumption for Trial Batches
API Eslicarbazepine Acetate
RM # 1912
Potency 99.20 %
Quantity
03 kg
Received
Carlep Tablets 200mg
Potency of Eslicarbazepine Acetate = 99.2 %
Potency Required Quantity = Standard Qty. x 100 / Potency
Adjustment = 200mg x 100/99.2
=201.6 mg/Tab
Trail Batch 01 Trail Batch 02
Trail Batch
1000 Tablets 1000 Tablets
201.6 mg x 1000 Tablets 201.6 mg x 1000 Tablets
= 201.6 g = 201.6 g
Total = 201.6 g + 201.6 g
= 403.2 g
=403.2 mg/Tab
Trail Batch
= 403.2 g = 403.2 g
Total = 403.2 g + 403.2 g
= 806.4 g
=806.4 mg/Tab
Trail Batch
= 806.4 g = 806.4 g
Total = 806.4 g + 806.4 g
= 1612.8 g
Quantity used in trial batches = 403.2 g + 806.4 g + 1612.8 g = 2.8224 kg
Quantity used in testing = 10.0 g
Total = 2.8324 kg
Carlep Tablets Range
Eslicarbazepine Acetate
API Consumption for Stability Batches
API Eslicarbazepine Acetate
RM # 2108
Potency 99.00 %
Quantity
07 kg
Received
= 202 mg/Tab
Stability Batch 01 Stability Batch 02 Stability Batch 03
1500 Tablets 1500 Tablets 1500 Tablets
202mg x 1500 202mg x 1500 202mg x 1500
Stability Batch Tablets Tablets Tablets
= 303.0 g = 303.0 g = 303.0 g
Total = 303.0 g + 303.0 g + 303.0 g
= 909.0 g
Potency Potency of Eslicarbazepine Acetate = 99.0 %
Adjustment Required Quantity = Standard Qty. x 100 / Potency
= 400mg x 100/99.0
= 404 mg/Tab
404 mg x 1500 404 mg x 1500 404 mg x 1500
= 606.0 g = 606.0 g = 606.0 g
Total = 606.0 g + 606.0 g + 606.0 g
= 1818.0 g
= 808 mg/Tab
808mg x 1500 808mg x 1500 808mg x 1500
= 1212.0 g = 1212.0 g = 1212.0 g
Total = 1212.0 g + 1212.0 g + 1212.0 g
= 3636.0 g
Quantity used in Stability batches = 909.0 g + 1818.0 g + 3636.0 g = 6.363 kg
Quantity used in testing = 10.0 g
Total = 6.373 kg
Total consumption of API
Trial Batches of Carlep Tablets Range + Q.C.
RM # 1912 2.8324 kg
Testing
Stability Batches of Carlep Tablets Range +
RM # 2108 6.373 kg
Q.C. Testing
Also note that:
Formulation applied on form 5-D in which all results meet as per pre-defined specifications and
no out of trends results were found. Furthermore, all physical and chemical parameters found
satisfactory. Therefore, same formulation applied on form 5-F.
Evaluation by PEC
The firm has changed the batch size and number of batches for product applied in M-289 to
justify the quantity of API.
Minutes 289 meeting Firms Response
Form 5 D
Strength Carlep Carlep Carlep Carlep Carlep Carlep
Tablet Tablet Tablet Tablet Tablet Tablet
200mg 400mg 800mg 200mg 400mg 800mg
Batch 1500 1500 1500 1000 1000 1000
Size Tablets Tablets Tablets Tablets Tablets Tablets
Batch TR001 TR001 TR001 TR001 TR001 TR001
No. TR002 TR002 TR002 TR002 TR002 TR002
TR003 TR003 TR003
Well along the firm further submitted on 30-12-2021.
“We request Evaluation cell to consider our product Carlep Tablet Range in Registration Board
once we submit additional data of the product in support of already submitted data to registration
board.”
Evaluation by PEC
Since 30-12-2021 firm has not submitted any additional data in order to support already submitted
data .The Registration Board may decide accordingly.
Decision of 322nd meeting: Deferred for the reconciliation record of the quantity drug substance
imported against the quantity required for the manufacturing of stability batches of each strength.
311. Name, address of Applicant / M/s Reliance Pharma Plot # 8, Street No. S-8, RCCI,
Marketing Authorization Holder Industrial Estate, Rawat Islamabad-Pakistan
Name, address of Manufacturing site. M/s Vision Pharmaceuticals (Pvt) Ltd Plot # 22-23,
Industrial Triangle, Kahuta Road, Islamabad"
☐ Importer
☒ Is involved in none of the above (contract giver)
Relimol Infusion
brand name
Strength / concentration of drug of Each 100ml Contains:
Active Pharmaceutical ingredient Paracetamol …1000mg
(API) per unit
Pharmaceutical form of applied drug Clear and colorless liquid filled in clear and colorless glass
vials.

Innovator Specifications
specifications
Proposed Pack size 1 glassVial (100ml)
The status in reference regulatory Acetaminophen 1g/100ml Infusion by Baxter Healthcare
authorities Coporation (United states), FDA Approved.
For generic drugs (me-too status) Provas Infusion by Sami Pharmaceuticals (Pvt) Ltd. Reg
No: 053223
GMP status of the Finished product GMP certificate valid till 10/02/2022
manufacturer New license Applied on 22/12/2021.
Name and address of API M/s HEBEI JIHENG PHARMACEUTICAL CO., LTD.
manufacturer. No.1 Weiwu Street Industrial Park Hengshui City, Hebei
Province, 053000 China.
submitted.
drug substance
Real time 60months : 30°C ± 2°C / 65% ± 5%RH for 60
months
Accelerated 6 months: 40°C ± 2°C / 75% ± 5%RH for 6
months
Batches: (011608001, 011608002 & 011608003)
impurities, specifications, analytical procedure (Liquid
particle count) and its verification studies, batch analysis
product.
Pharmaceutical equivalence and Pharmaceutical Equivalence has been established against
comparative dissolution profile the reference product OFIRMEV Infusion by
Mallinckrodt Pharmaceuticals. Batch No 1019689 by
performing quality tests (Physical appearance, pH, Liquid
Particle count, Percent assay).
Analytical method Method verification studies have submitted including
Manufacturer of API M/s HEBEI JIHENG PHARMACEUTICAL CO., LTD.
No.1 Weiwu Street Industrial Park Hengshui City, Hebei Province,
053000 China.
API Lot No. 011803173
Description of Pack
Clear glass vial
Real Time: 0, 3, 6, 9, 12, 18, 24 & 36 (Months)
Batch No. 0718801 0718802 0718803
No. of Batches 03
REQUEST OF EXEMPTION FROM ON SITE INSPECTION
The firm has requested for Exemption from On-site Investigation of their submitted stability data and
provided the following documents in conjunction with the checklist approved by the Registration Board.
1. Reference of previous approval of N/A
2. Approval of API/ DML/GMP Copy of drug production license certificate No.

certificate of API manufacturer issued JI20150076 issued by Hebei Drug Administration valid
by concerned regulatory authority of till 30/08/2025 has been submitted.
country of origin.
3. Documents for the procurement of Copy of clearance certificate dated 31-05-2018 is
API with approval from DRAP (in submitted .
case of import).
supported by attested respective Submitted
sheets etc.
5. Compliance Record of HPLC Not Submitted.
on product testing
accelerated)
Sr. Section Observations/ Deficiencies Response submitted by Firm and
No. Evaluation
1 1.4.3 • Provide notarized copy of contract • Notarized copy of Contact
manufacturing agreement manufacturing agreement.
• Provide documents confirming Copy of agreement
number of approved sections of • Section approval letter of Applicant
the applicant (DML holder) (DML holder)
• Provide details of already 4 sections
registered drug products of • List of already registered drug products
contact giver on contract of contact giver on contract
manufacturing, manufacturing.
6 Products
2 2.3.S.3.1 • Submit conclusion from the list of • Based on the analysis of the Paracetamol
studies performed (e.g IR, UV, samples produced in Hebei Jiheng
NMR, MS, Elemental analysis.) Pharmaceutical Co. Ltd. , and with the
comparison to results of the Paracetamol
EP CRS (Batch No.: 4.1), we confirm
that
Paracetamol sample matches the
chemical structure below,
which is defined as the

structure of Paracetamol in EUR.
Ph. 8.
The crystal form of the product is
identical with EP CRS Lot 4.1.
the summary is provided in
ANNEXURE 2.
3 2.3.S.4.4 • Submit discussion and • Complete testing is performed and
justification for any incomplete revised COA is attached in
analysis of the drug substance/API ANNEXURE 3
by drug product manufacturer. Evaluation
• The COA of API of DP The COA mentions supplier/manufacturer
manufacturer mentions reference as M/s Global pharmaceuticals.
• We use BP specification as reference
of API manufacturer both USP
for testing; USP was only referred for
and BP.
verification purpose.
4 2.3.P.1 • The quantity of API per unit is • As per Standard for fill volume we go
1020mg per 100ml whereas the for the upper limit therefore the fill
applied strength is volume of paracetamol infusion is
1000mg/100ml. clarification is 102ml for which we use 1020mg of
required with respect to paracetamol API.
composition of FPP. Evaluation
Submit scientific rationale for batch
formula.
The BMR mentions the Quantity of API
1000mg/100ml.
Potency adjustment has not been done.
5 2.3.P.2.2.1 The pharmaceutical equivalence As we have already approved paracetamol
studies of applied formulation is with infusion Brand Name: ACETAMOL 100ml
Orfimex 100ml infusion whose INFUSION- manufacturer Vision
marketing status is discontinued as Pharmaceuticals Pvt. Ltd.
per USFDA database. We will submit pharmaceutical equivalence
with Brand leader as soon as possible.
6 2.3.P.5.1 The specification of drug Product We have now included the test for
does not include the test of osmolality osmolality in our standard analytical
which has been both determined by procedures.
innovator and generic product the pH
of both generic and innovator product The revised standard analytical procedure
is between 5 – 7 whereas your and COA is attached in ANNEXURE 4
claimed specification are pH 4 – 7.
7 2.3.P.5.6 Provide justification of specification Specification of product is as per Innovator
of all the tests specified in section specs.
2.3.P.5.1
8 3.2.S.4.2 Detailed analytical procedures for A detailed analytical procedure for testing
testing of drug substance shall be of drug substance by the drug product
provided by the drug product manufacturer for API has been provided.
manufacturer for API.
9 3.2.S.4.3 Analytical method verification studies Analytical method verification studies
including specificity, Accuracy and including specificity, Accuracy and
repeatability (method precision) repeatability (method precision) performed
performed by the drug product by the drug product manufacturer for API
manufacturer shall be submitted for has been provided.
API.
10. 3.2.S.4.4 A discussion and justification shall be • Complete testing is performed and
provided for any incomplete analysis revised COA has been submitted.
of the drug substance/ API by drug • We use BP specification as reference
for testing; USP was only referred for
verification purpose.
Decision of 320th Meeting: Deferred for;
• Justification for not performing pharmaceutical equivalence against the reference / innovator’s
product.
• Clarification regarding the specification of drug Product does not include the test of osmolality
which has been both determined by innovator and generic product the pH of both generic and
innovator product is between 5 – 7 whereas your claimed specification are pH 4 – 7.
• Clarification since potency adjustment has not been made.
• Submission scientific rationale for submitted batch formula.
Evaluation by PEC:
Decision Firms Response
Justification for not performing pharmaceutical Firm has now performed pharmaceutical equivalence
equivalence against the reference / innovator’s with Bofalgan Infusion 100ml.
product.
Clarification regarding the specification of drug Firm has updated the standard testing method by
Product does not include the test of osmolality including the test of osmolality and also revised pH
which has been both determined by innovator and specifications.
generic product the pH of both generic and
innovator product is between 5 – 7 whereas your
claimed specification are pH 4 – 7.
Clarification since potency adjustment has not In fact, we are adjusting the potency but in current
been made. formulation already sent the potency of material
100%.
Submission scientific rationale for submitted We are calculating the active material as per 102ml
batch formula. , because USP recommends excess volume of 2 %
for 100ml solution.
Decision: Approved.
• Registration letter will be issued upon submission of analysis of stability batches as per revised
limits of pH test.
Item No. VII: Agenda of Evaluator-XVI (Mr. Akbar Ali)
Case No 1 : Export Facilitation ( out of que ) Cases : (Human, Local, Form-5F)

M/s Indus Pharma ( Pvt) Ltd ,Karachi
Assistant Director PR-I / EFD vide its letter No. F.1-6/2019-PR-I (EFD) dated 6th October 2022
informed that as per decision of 133rd meeting of DRAP Authority wherein it was decided to grant
registration on priority basis to the pharmaceutical i.e. one molecule for each 100,000 USD worth of
export of medicine (to a maximum of 15 such molecules) during a financial year.
In compliance to the above decision M/s Indus Pharma ( Pvt) Ltd ,Karachi have achieved benchmark
of more than 100,000 USD and submitted their applications for priority consideration including
following applications
312. Name, address of Applicant / Marketing M/s Indus Pharma (Pvt.) Ltd. Plots No. 26-27
Authorization Holder & 63-67, sector-27 Korangi Industrial Area,
Karachi – 74900, Pakistan
Name, address of Manufacturing site. M/s Indus Pharma (Pvt.) Ltd. Plots No. 26-27
& 63-67, sector-27 Korangi Industrial Area,
☐ Importer
giver)
☐ Export sale
Details of fee submitted PKR 30,000/= Slip No. 4658125907 dated
27/04/2022
The proposed proprietary name / brand name Razan 10mg tablets
Pharmaceutical ingredient (API) per unit Vonoprazan Fumarate …….10mg
Pharmaceutical form of applied drug light yellow, oval shape, film-coated tablet with
“Indus” engraved on one side and other side is
plain.
Pharmacotherapeutic Group of (API) potassium-competitive acid blockers
Reference to Finished product specifications As per Innovator Product
Proposed Pack size 7's, 14's, 28's, 30's
The status in reference regulatory authorities Takecab tablets 10mg by Takeda
Pharmaceuticals.
PMDA Japan
For generic drugs (me-too status) Vonozan Tablet by M/s Getz Pharma (Pvt.) Ltd,
Reg. No. 108570
GMP status of the Finished product GMP renewed on 24/12/2021
manufacturer Valid till: 17/12/2023
Name and address of API manufacturer. M/s Jiangxi Synargy Pharmaceutical Co., Ltd.
Jiangxi Fengxin Industrial Park, Fengxin,
330700,Jiangxi Provence P.R. Chaina.
submitted.
impurity (Impurity VOPZ-ZBB, VOPZ-ZBC,
VOPZ-SJJ) & related substances specifications,
months
months
Batches:(2190801BD,2190802BD,2190803BD,
)
dissolution profile established against the brand leader that is
Vonozan 10mg Tablets (005FF8) by Getz
Pharma (Pvt.) Ltd by performing quality tests
(Identification, Assay, Dissolution,
Disintegration).
that is Vonozan 10mg Tablets by Getz Pharma
(Pvt.) Ltd Pharma in Acid media (pH 1.2),
acceptable range.
product including System Suitability, Precision,
Specificity, linearity, range, accuracy,
robustness.
Manufacturer of API M/s Jiangxi Synargy Pharmaceutical Co., Ltd.
Jiangxi Fengxin Industrial Park, Fengxin, 330700,Jiangxi Provence
P.R. Chaina.
API Lot No. 20210801BD
Description of Pack Alu. Alu. Blister strips of 2x5 Tablets packed in a final printed carton.
Real Time: 0, 3, 6,9,12,18,24 (Months)
Batch No. TR-1/ VNZ 10mg TR-3/ VNZ 10mg
TR-2/ VNZ 10mg TAB
TAB TAB
No. of Batches 03
27. Reference of previous approval of applications Canazin tablet 300mg
with stability study data of the firm (if any) Minutes of 289th Meeting of Registration Board
(14-16 May,2019)
28. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. GAN 20160125
API manufacturer issued by concerned issued by Jiangxi Provincial Medical Products
regulatory authority of country of origin. Administration (Sealed) valid till 03/11/2025.
wherein the permission to import Vonoprazan
Fumarate for the purpose of test/analysis and
stability studies is granted.
chromatograms,
etc.
Sr. Section Observation Firm’s Response vide dairy
# # No.301655 dated 24-10-2022.
1. 1.5.2 The provided label claim mentioning
Please note that the label claim
strength/concentration of API per
provided in section 1.5.2 contains
unit:
typographical error, the correct one
is
Vonoprazan fumarate…………10
mg,
Vonoprazan (as Fumarate) … 10mg
Whereas the innovator is Vonoprazan
(as Fumarate) …………. 10 mg,
Clarification and resubmission is
needed
2. 2.3.S.1. • The physical description of API is • The physical description of API
3 provided as, “White to almost white “white to almost white powder” was
powder”, whereas the innovator derived from the manufacturer
product literature mentions as “white
to almost white crystals or crystalline specification as the Vonoprazan
powder”. Clarification is needs fumarate is a non-compendial API,
where the applied API is crystalline however we have examined the API
powder or amorphous powder and and found it to be crystalline. Also,
justification in case of amorphous
in the DMF XRD spectrum of
powder.
• Melting point test is not conducted Vonoprazan Fumarate has been
whereas melting point of innovator attached for crystal analysis which
product API is 194.8 degree Celsius. clearly indicating that the substance
• Pka value is different from the is in crystalline form and
innovator reverence product. crystallization step is mentioned at
the last stage of manufacturing
procedure of API. (Attached
• Melting point test is not conducted by
API supplier for Identification.
Instead of Melting Point API
supplier have conducted IR and
HPLC test whose results can be
found API COAs attached.
• Pka value mentioned in the section
was a typographical error i.e 9.06
instead of 9.6.
• Corrected one is attached with this
document (Attachment-II).
3. 3.2.P.5. The Finished product release The Limit for dissolution Test for
1 specification for dissolution test is Finished product was not mentioned
mentioned as not less than Q of as not less than Q of labelled amount
labelled amount of Vonoprazan in 30
minutes , whereas the innovator of Vonoprazan in 15 minutes due to
product has dissolution parameter of unavailability of any published
achieving Q within 15 minutes , literature for dissolution parameters
clarification is needed. at the time of initial development of
the product. However according to
CDP studies (already submitted) our
product also releases > 85% within
15 minutes throughout the range of
pH 1.2, 4.5 & 6.8.
We hereby, commit to change the
dissolution parameter to achieving Q
within 15 minutes at the time of
commercialization of product
4. 3.2.P.8. The firm has provided stability data The stability data up to 6 months for
3 up to three months’ timeline for both both accelerated and real time stability
accelerated and real time stability data study data has been attached with this
, The stability study data up to 6 Document (Attachment-III).
months’ timeline is required for both
accelerated and real time stability
study data.
submitted in the registration application
• Registration letter shall be issued after submission of applicable fee for pre-registration
variation ,i-e 30000/= as per notification No.F.7-11/2012-B&A/DRAP dated 07- 05-2021
for correction in label claim..
☐ Importer
giver)
☐ Export sale
Details of fee submitted PKR 30,000/-:1138595321 dated 09/05/2022
The proposed proprietary name / brand name Razan 20mg tablets
Pharmaceutical ingredient (API) per unit Vonoprazan Fumarate ………………….20mg
Pharmaceutical form of applied drug light yellow, oval shape, film-coated tablet with
plain.
Pharmacotherapeutic Group of (API) potassium-competitive acid blockers
Proposed Pack size 7's, 14's, 28's, 30's
The status in reference regulatory authorities Takecab tablets 20mg by Takeda
Pharmaceuticals.
For generic drugs (me-too status) Vonozan Tablet by M/s Getz Pharma (Pvt.) Ltd,
Reg. No. 108571
Name and address of API manufacturer. M/s Jiangxi Synargy Pharmaceutical Co., Ltd.
Jiangxi Fengxin Industrial Park, Fengxin,
330700,Jiangxi Provence P.R. Chaina
submitted.
impurity (Impurity VOPZ-ZBB, VOPZ-ZBC,
VOPZ-SJJ) & related substances specifications,
months
months
Batches:(2190801BD,2190802BD,2190803BD,
)
Vonozan 20mg Tablets (004FF9) by Getz
Pharma (Pvt.) Ltd by performing quality tests
(Identification, Assay, Dissolution,
Disintegration).
that is Vonozan 20mg Tablets by Getz Pharma
(Pvt.) Ltd Pharma in Acid media (pH 1.2),
acceptable range.
Specificity, linearity, range, accuracy,
robustness.
Manufacturer of API M/s Jiangxi Synargy Pharmaceutical Co., Ltd.
Jiangxi Fengxin Industrial Park, Fengxin, 330700,Jiangxi Provence
P.R. Chaina
Description of Pack
Alu. Alu. Blister strips of 2x5 Tablets packed in a final printed carton.
Real Time: 0, 3, 6,9,12,18,24 (Months)
Batch No. TR-1/ VNZ 20mg TR-3/ VNZ 20mg
TR-2/ VNZ 20mg TAB
TAB TAB
No. of Batches 03
(14-16 May,2019)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. GAN 20160125
API manufacturer issued by concerned issued by Jiangxi Provincial Medical Products
regulatory authority of country of origin. Administration (Sealed) valid till 03/11/2025.

wherein the permission to import Vonoprazan
Fumarate for the purpose of test/analysis and
chromatograms,
etc.
Sr. Section Observation Firm’s Response vide Dairy No.30164
# # dated 24-10-2022
5. 1.5.2 The provided label claim
Please note that the label claim
mentioning strength/concentration
provided in section 1.5.2 contains
of API per unit:
typographical error, the correct one is
Vonoprazan fumarate…………20
Vonoprazan (as Fumarate) … 20mg
mg,
Whereas the innovator is
Vonoprazan (as Fumarate)
…………. 20 mg,
needed .
6. 2.3.S.1. • The physical description of API is • The physical description of API
3 provided as, “White to almost “white to almost white powder” was
white powder”, whereas the derived from the manufacturer
innovator product literature
mentions as “white to almost white specification as the Vonoprazan
crystals or crystalline powder”. fumarate is a non-compendial API,
Clarification is needs where the however we have examined the API
applied API is crystalline powder and found it to be crystalline. Also, in
or amorphous powder and
the DMF XRD spectrum of
powder. Vonoprazan Fumarate has been
• Melting point test is not conducted attached for crystal analysis which
whereas melting point of innovator clearly indicating that the substance is
product API is 194.8 degree in crystalline form and crystallization
Celsius. step is mentioned at the last stage of
• Pka value is different from the manufacturing procedure of API.
innovator reverence product.
(Attached
• Melting point test is not conducted by
API supplier for Identification.
Instead of Melting Point API
supplier have conducted IR and
HPLC test whose results can be
found API COAs attached.
• Pka value mentioned in the section
was a typographical error i.e 9.06
instead of 9.6.
• Corrected one is attached with this
document (Attachment-II).
7. 3.2.P.5. The Finished product release The Limit for dissolution Test for
1 specification for dissolution test is Finished product was not mentioned as
mentioned as not less than Q of not less than Q of labelled amount
labelled amount of Vonoprazan in
30 minutes , whereas the innovator of Vonoprazan in 15 minutes due to
product has dissolution parameter of unavailability of any published
achieving Q within 15 minutes ,
clarification is needed.
8. 3.2.P.8. The firm has provided stability data The stability data up to 6 months for both
3 up to three months’ timeline for accelerated and real time stability study
both accelerated and real time data has been attached with this
stability data , The stability study Document (Attachment-III).
data up to 6 months’ timeline is
required for both accelerated and
real time stability study data.
variation ,i-e 30000/= as per notification No.F.7-11/2012-B&A/DRAP dated 07- 05-2021
for correction in label claim..
Name, address of Manufacturing site. M/s Nabiqasim Industries (Pvt) Ltd, 17/24,
☐ Importer
☒ Is involved in none of the above (contract
giver)
☐ Export sale
Details of fee submitted PKR 75,000/-: sip No. 4585817201 dated
14/10/2021
The proposed proprietary name / brand name Vanco IV 500mg Injection
Pharmaceutical ingredient (API) per unit Vancomycin Hydrochloride USP equivalent to
Vancomycin …….500mg
( as lyophilized powder for injection)
Pharmaceutical form of applied drug A white to almost white color cake/powder on
reconstitution form light tan color clear
transparent liquid free from particles and fibers.
Pharmacotherapeutic Group of (API) Tricyclic glycopeptide antibiotics.
Reference to Finished product specifications As per USP Specification
The status in reference regulatory authorities Product is registered and being marketed in USA
& UK by Hospira and MYLAN LABS LTD.
For generic drugs (me-too status) Vanbact I.V. 500mg Injection by M/s Nabiqasim
Industries (Pvt.) Ltd, Reg. No. 070682
Name and address of API manufacturer. M/s Livzon Group Fuzhou Fixing
Pharmaceutical Co, Ltd
Jiangyin industrial zone Fuqing Fuzhou City
Fujian Province, P.R. China
submitted.
impurity (Impurity B) & related substances
substance
Real time: 5°C ± 3°C for 36 months
Accelerated: 25°C ± 2°C / 60% ± 5% RH for 6
months
Batches:(0905001,0905002,0905003)
Vancomycin 500mg IV Injection by Abbott
Laboratories by performing quality tests
(description, pH, Assay, Microbial Limit).
product including, Precision, Specificity, accuracy.
ABILITY STUDY DATA
Manufacturer of API M/s Livzon Group Fuzhou Fixing Pharmaceutical Co, Ltd
Jiangyin industrial zone Fuqing Fuzhou City Fujian Province, P.R.
China.
API Lot No. HAF1910029
Description of Pack Product will be supplied in Glass vial with 1 ampoule of 10ml sterile
(Container closure system) water for injection.
Real Time: 0, 3, 6,9,12,18,24 (Months)
Batch No. VIC001 VIC002 VIC003
No. of Batches 03
1. Reference of previous approval of applications Esorid 40mg IV Injection
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. FJ200002 issued
API manufacturer issued by concerned by (FIJIAN) FOOD AND DRUG
3. Documents for the procurement of API with • Copy of invoice No.FXIN2002251A dated
approval from DRAP (in case of import). 19-03-2020 cleared on 15/5/2020 is submitted
wherein the permission to import Vancomycin
Hydrochloride for the purpose of test/analysis
chromatograms,
etc.
Remarks OF Evaluator
Sr. Section# Observation Response of firm vide dairy No.31105
# dated 01-11-2022
1. 3.2.S.4.2 The claimed testing • Firm has submitted a declaration certificate
specifications of API , issued by contract manufacturer, M/s
(Vancomycin Hcl) are USP Nabiqasim Industries (pvt) Ltd , Khi,dated
specifications , however the 05-03-2020 stating that , “ With reference to
provided method for subjected matter, it is to inform you that
conducting Microbial except dilutions in the provided method all
Assay/Potency of the parameters including reference standard,
Vancomycin is different from sample preparation , analytical
USP method and justification technique(Gel diffusion method, culture,
is required to establish the medium) are same as described in USP and
provided formula for as far as the dilution is concerned we have
calculating Potency is validated and verified analytical method.
equivalent to USP method as In addition to this firm now and onward the
provided in Microbial Assay we have revised our monograph including
(81) of Antibiotics. dilutions as per current chapter of USP (81)
Antibiotic-Microbial Assay.
• Firm has also submitted revised Analytical
specification of Vancomycin Hcl (API)
pyrogen free mentioning analytical
specifications and assay method. The
document is issued by contract
manufacturer and issued date is 29-10-2022
and effective date is 01-11-2022.

• Firm shall submit COA of API (Vancomycin) after conducting Antimicrobial Assay test
as per pharmacopeia /USP method and results shall be calculated as per the given formula
in USP method as provided in Microbial Assay (81) of Antibiotics.
• Registration letter shall be issued after submission of applicable fee of 7500/=for pre-
registration variation as per notification No.F.7-11/2012-B&A/DRAP dated 07- 05-2021.
• Capacity assessment of M/s Nabiqasim Industries, Karachi shall be conducted before
issuance of Registration letter.
Name, address of Manufacturing site. M/s Nabiqasim Industries (Pvt) Ltd, 17/24,
☐ Importer
☒ Is involved in none of the above (contract
giver)
☐ Export sale
Details of fee submitted PKR 75,000/-: slip No. 7466843241 dated
14/10/2021
The proposed proprietary name / brand name VANCO IV 1g Injection
Pharmaceutical ingredient (API) per unit Vancomycin Hydrochloride USP equivalent to
Vancomycin …….1g
( as lyophilized powder for injection)
Pharmaceutical form of applied drug A white to almost white color cake/powder on
reconstitution form light tan color clear
transparent liquid free from particles and fibers.
Pharmacotherapeutic Group of (API) Tricyclic glycopeptide antibiotics.
Reference to Finished product specifications As per USP Specification
The status in reference regulatory authorities Product is registered and being marketed in USA
by Hospira (FDA approved)
For generic drugs (me-too status) Vanbact I.V. 1g Injection by M/s Nabiqasim
Industries (Pvt.) Ltd, Reg. No. 070682
GMP status of the Finished product GMP Dated 06/10/2020
Name and address of API manufacturer. M/s Livzon Group Fuzhou Fixing
Pharmaceutical Co, Ltd
Jiangyin industrial zone Fuqing Fuzhou City
Fujian Province, P.R. China
submitted.
impurity (Impurity B) & related substances
substance
Real time: 5°C ± 3°C for 36 months
Accelerated: 25°C ± 2°C / 60% ± 5% RH for 6
months
Batches:(0905001,0905002,0905003)
Vancomycin 1g IV Injection by Abbott
Laboratories by performing quality tests
(description, pH, Assay, Microbial Limit).
product including, Precision, Specificity, accuracy.
Manufacturer of API M/s Livzon Group Fuzhou Fixing Pharmaceutical Co, Ltd
Jiangyin industrial zone Fuqing Fuzhou City Fujian Province, P.R.
China
API Lot No. HAF1910029
Description of Pack Product will be supplied in Glass vial with 1 ampoule of 10ml sterile
(Container closure system) water for injection.
Real Time: 0, 3, 6, 9,12,18,24(Months)
Batch No. VBB006 VBC001 VBC002
Batch Size 111 L 111 L 111 L
No. of Batches 03
1. Reference of previous approval of applications Esorid 40mg IV Injection
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. FJ200002 issued
API manufacturer issued by concerned by (FIJIAN) FOOD AND DRUG
3. Documents for the procurement of API with • Copy of invoice No.FXIN2002251A dated
approval from DRAP (in case of import). 19-03-2020 cleared on 15/5/2020 is submitted
wherein the permission to import Vancomycin
Hydrochloride for the purpose of test/analysis
chromatograms,
etc.
Sr. Section# Observation Response of firm vide dairy No. 31105
# dated 01-11-2022
1. 3.2.S.4.2 The claimed testing specifications • Firm has submitted a declaration
of API , (Vancomycin Hcl) are certificate issued by contract
USP specifications , however the manufacturer, M/s Nabiqasim
provided method for conducting Industries (pvt) Ltd , Khi,dated 05-03-
Microbial Assay/Potency of 2020 stating that , “ With reference to
Vancomycin is different from subjected matter, it is to inform you that
USP method and justification is except dilutions in the provided method
required to establish the provided all the parameters including reference
formula for calculating Potency is standard, sample preparation ,
equivalent to USP method as analytical technique(Gel diffusion
provided in Microbial Assay (81) method, culture, medium) are same as
of Antibiotics. described in USP and as far as the
dilution is concerned we have validated
and verified analytical method.
In addition to this firm now and onward
the we have revised our monograph
including dilutions as per current
chapter of USP (81) Antibiotic-
Microbial Assay.
• Firm has also submitted revised
Analytical specification of
Vancomycin Hcl (API) pyrogen free
mentioning analytical specifications
and assay method. The document is
issued by contract manufacturer and
issued date is 29-10-2022 and effective
date is 01-11-2022.

• Firm shall submit COA of API (Vancomycin) after conducting Antimicrobial Assay test
as per pharmacopeia /USP method and results shall be calculated as per the given formula
in USP method as provided in Microbial Assay (81) of Antibiotics.
• Registration letter shall be issued after submission of applicable fee of 7500/=for pre-
registration variation as per notification No.F.7-11/2012-B&A/DRAP dated 07- 05-2021.
• Capacity assessment of M/s Nabiqasim Industries, Karachi shall be conducted before
issuance of Registration letter.
☐ Importer
giver)
☐ Export sale
Details of fee submitted PKR 30,000/-: slip No. 2643439006 dated
18/03/2022
The proposed proprietary name / brand name Penol IR Tablets 75mg.
Pharmaceutical ingredient (API) per unit Tapentadol HCl eq to Tapentadol…..75mg
Pharmaceutical form of applied drug A light pink, round shape, film-coated tablet with
plain.
Pharmacotherapeutic Group of (API) Centrally Acting Analgesic
The status in reference regulatory authorities NUCYNTA immediate-release oral tablets by
Janssen Ortho, LLC Gurabo, PR 00778
U.S. Food & Drug Administration
For generic drugs (me-too status) Tapento IR by M/s Sami Pharmaceuticals(Pvt)
Ltd., F-95,
SITE Karachi, Reg. No. 093064
Name and address of API manufacturer. Ami Lifesciences Private
Limited. Block No.82/B, ECP Road,
AT & Post: Karakhadi391450, Taluka: Padra,
District Vadodara Gujarat,
INDIA.
submitted.
impurity & related substances specifications,
months
months
Batches:(TPT/50111119,TPT/50121119,TPT/50
131219,)
Tapento IR Tablets 75mg (003G) by M/s Sami
Pharmaceuticals (Pvt) Ltd. by performing quality
Disintegration).
that is Tapento IR Tablets 75mg by M/s Sami
Pharmaceuticals (Pvt) Ltd. in Acid media (pH
1.2), Acetate Buffer (pH 4.5) & Phosphate Buffer
(pH 6.8). The values for f1 and f2 are in the
acceptable range.
Specificity, linearity, range, accuracy, and
repeatability.
Manufacturer of API Ami Life sciences Pvt. Ltd.
API Lot No. TPT/50010121
Description of Pack
Alu. Alu. Blister strips of 10x1 Tablets packed in a final printed carton.
Real Time: 0, 3, 6, 9,12,18,24 (Months)
Batch No. TR-1/ TPD TR-2/ TPD TR-3/ TPD
75mg Tab 75mg Tab 75mg Tab
No. of Batches 03
(14-16 May,2019)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. 19041306 issued
API manufacturer issued by concerned by Food & Drug Control Administration valid
regulatory authority of country of origin. till 24/04/2022.
3. Documents for the procurement of API with • Copy of Invoice No.EXP/1/21-22/0129 dated
approval from DRAP (in case of import). 21/06/2021 is submitted wherein the
permission to import Tapentadol HCl for the
granted.
• DRAP ADC attestation Date is 24-06-2021

chromatograms,
etc.
Sr. Section# Observation Response of firm vide dairy
# No.30761 dated 31-10-2022
1. 1.5.5 Firm has mentioned It is a typo error, revised
Pharmacological class of API as, Pharmacological class of API as,
“Antidiarrheal”. Clarification is “opioid Analgesic” is submitted.
needed.
2. 2.3.P.3.4 • Firm has mentioned Acceptance • We, Indus Pharma (Pvt.) Ltd., opted for
criteria for disintegration test NMT acceptance criteria for disintegration
15 minutes under compression step test NMT 15 minutes in 3.P.3.4 which
of Product manufacturing ,whereas is under compression step (i.e. for Core
under section 2.3.P.5.1 firm has tablet), whereas under section 2.3.P.5.1
mentioned specifications ofspecification for disintegration test is
Disintegration test as NMT 30 NMT 30 minutes (i.e. Film coated
minutes, which needs clarification. tablet) because as per the specified
limits of Ph. Eur. monograph tablets
(0478), the limit for disintegration test
for Uncoated tablet is NMT 15minutes
while for Film Coated is NMT
30minutes. The stated monographs are
attached for your reference:
3. 3.2.P.8.3 The firm has provided stability data Stability data up to 3rd month already
up to three months’ timeline for both submitted to you while remaining data
accelerated and real time stability of 6 month stability study is attached.
data , The stability study data up to
6 months’ timeline is required for
both accelerated and real time
stability study data.
• Registration Board further decided that registration letter shall be issued after submission
of applicable fee of 7500/=for pre-registration variation, as per notification No.F.7-
11/2012-B&A/DRAP dated 07- 05-2021.
Case No 2: Export Facilitation (out of que) Cases: (Human, Local, Form-5F)
M/s NABIQASIM INDUSTRIES (PVT) LTD. Karachi
In compliance to the above decision M/s M/s NABIQASIM INDUSTRIES (PVT) LTD.,Karachi have
achieved benchmark of more than 100,000 USD and submitted their applications for priority
consideration including following applications
317. Name, address of Applicant / Marketing M/s NABIQASIM INDUSTRIES (PVT) LTD.
Authorization Holder 17 / 24, Korangi Industrial Area,
Telephone: + (21) 32213886, 32633590, UAN
111-742-762
Name, address of Manufacturing site. M/s NABIQASIM INDUSTRIES (PVT) LTD.
Telephone: + (21) 32213886, 32633590, UAN
111-742-762
☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand name VONTAB 20mg Tablet
Strength / concentration of drug of Active Each film-coated tablet:
Pharmaceutical ingredient (API) per unit Vonoprazan Fumarate equivalent to
Vonoprazan…20mg
Pharmaceutical form of applied drug Red colored, round shaped, film coated tablet,
both sides plain oral tablet.
Pharmacotherapeutic Group of (API) Potassium-competitive acid blocker.
Proposed Pack size 7’s, 14’s, 28’s & 30’s tablets
The status in reference regulatory authorities Takecab Tablets (Vonoprazan) is registered and
being marketed by Takeda Pharmaceuticals
(Approved by Pharmaceuticals and Medical
Devices Agency, Japan).
For generic drugs (me-too status) Vonozan Tablet 20mg by M/s Getz Pharma
Private Limited, Reg. No. 108571
GMP status of the Finished product New GMP Certificate granted on 28/05/2022.
manufacturer Tablet (General & Antibiotic), Capsule (General
& Cephalosporin), Dry Powder for Suspension
(General Antibiotic &Cephalosporin), Oral
Liquid (Syrup) (Non-Antibiotic & Antibiotic),
Cream / Ointment / Lotion (Non-Antibiotic &
Antibiotic & Steroids), Eye & Ear Drops (Non-
Antibiotic & Antibiotic & Steroids), Liquid
Enema (General), Sachet (General), Small
Volume Lyophilized Injectable (Non-Antibiotic,
Antibiotic), Gel & Tablet (Hormones) sections
approved.
Name and address of API manufacturer. M/s Yibin Hongguang Pharmaceutical Co., Ltd.
Luolong country
NanxiDistrict,YibinCity,SichuanProvince,
PC-644100,China
procedures and its verification / validation, batch
Module III (Drug Substance) Monograph of Vonoprazan Fumarate is present
is as per In-house (Manufacturer’s)
controls, tests for related substances (Individual
impurity, total impurity), specifications,
months
months
Batches: (MS103201-190501, MS103201-
190502, MS103201-190503)
and buffer medium) and its validation studies,
Takecab Tablets (Vonoprazan) is registered and
being marketed by Takeda Pharmaceuticals, by
Identification, Dissolution and Assay).
that is Vonozan Tablet 20mg (Vonoprazan) by
Getz Pharma Private Limited, in Acid media (pH
1.2) & Phosphate Buffer (pH 4.5 & 6.8). The
product including linearity, range, accuracy, precision,
specificity.
Manufacturer of API M/s Yibin Hongguang Pharmaceutical Co., Ltd.
Luolong country NanxiDistrict,YibinCity,SichuanProvince,
PC-644100,China
API Lot No. MS103201-210501
Description of Pack
Alu-Alu blister 7’s, 14’s, 28’s & 30’s tablets packed in unit carton.
Batch No. 450DS01 450DS02 450DS03
No. of Batches 03
1. Reference of previous approval of applications Submitted.
with stability study data of the firm (if any)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate issued by Yibin
API manufacturer issued by concerned Association of Pharmaceutical Industry, Yibin,
regulatory authority of country of origin. Sichuan, China valid till 16/03/2025. Firm has
also provided copy of Drug Manufacturing
License ( valid up to(29-12-2025) issued by
Sichuan Medical products Administration ,which
is varied online.
3. Documents for the procurement of API with Copy of invoice no MC120210531-004 dated 31-
approval from DRAP (in case of import). 05-2021 duly attested by Assistant Director,

chromatograms,
etc.
Observations Firms response vide dairy NO.29738
dated 20-08-2022
2.3.S.1. • Melting point test is not conducted • The melting point of innovator product API
3 whereas melting point of innovator is 194.8 degree Celsius, we have revised our
product API is 194.8 degree API testing specifications same has been
Celsius. attached in Annexure-A and also
incorporated melting point test
specifications on it for future QC release.
• We also conducted melting point test on
retention sample of Vonoprazan Fumarate
API and found satisfactory results as
mention below
Serial No. Test Observed Results
Specifications
01 Melting Point Sample 1= 194.9°C.
194.8 °C. Sample 2 = 194.8°C
Sample 3 = 194.9°C
Average = 194.8°C
• The Pka value is 9.6
• Pka value is missing
3.2.P.5. • The finished product release • Vonoprazan is a highly soluble drug
1 specification for dissolution test is substance, based on ICH Q6A, which states
mentioned as not less than Q of that the drug substance should be considered
labelled amount of Vonoprazan in highly soluble if it meets following
30 minutes, whereas the innovator conditions:
product has dissolution parameter • “The dissolution profile of all strengths of
of achieving Q within 15 minutes, the dosage form should be rapid i.e.
clarification is needed. Dissolution > 80% in 15 minutes at pH 1.2,
4.0 & 6.8.”
• Vonotab tablet 10 mg & 20mg as well as
the reference product “Vonoget Tablets” by
Getz Pharma releases more than 85% in all
three mediums within 15 minutes at 50
RPM which is reflected by comparative
dissolution profile studies.
• As per USP general chapter<1092>
“Dissolution Procedure: Development and
Validation”, Immediate release dosage form
should release within 30 to 60 minutes.
3.2.P.8. • The firm has provided stability Therefore, we select the lowest time point
3 data up to three months’ timeline i.e. 30 minutes for dissolution.
for both accelerated and real time • Moreover, Reference to the decision of
stability data. The stability study “Minutes of 294th Meeting of
data up to 6 months’ time line is Registration Board” case of Reference
required for both accelerated and product “Vonoget 20mg Tablet” by M/s
real-time stability data. Getz Pharma(Pvt) Ltd. was approved having
time interval for dissolution test at 30
minutes. (Attached in Annexure-B)
• we have already submitted 06 months’
stability data on 11th March 2022, attached
is the copy of receiving for ready reference.
submitted in the registration applicationRegistration Board further decided that,
• Registration Board further decided that, firm shall submit revised COA after setting
dissolution test specification as NLT 85 % within 15 minutes before issuance of
of applicable fee of 7500/= for pre-registration variation, as per notification No.F.7-
11/2012-B&A/DRAP dated 07- 05-2021.
318. Name, address of Applicant / Marketing M/s NABIQASIM INDUSTRIES (PVT) LTD.
Authorization Holder 17 / 24, Korangi Industrial Area,
Telephone: + (21) 32213886, 32633590, UAN
111-742-762
Name, address of Manufacturing site. M/s NABIQASIM INDUSTRIES (PVT) LTD.

Telephone: + (21) 32213886, 32633590, UAN
111-742-762

☐ Importer
giver)
☐ Export sale
Dy. No. and date of submission Dy. No.1654 dated 18-01-2022
The proposed proprietary name / brand name VONTAB 10mg Tablet
Strength / concentration of drug of Active Each film-coated tablet:
Pharmaceutical ingredient (API) per unit Vonoprazan Fumarate equivalent to
Vonoprazan……………………..…………10m
g
Pharmaceutical form of applied drug Yellow colored, round shaped, film coated tablet,
both sides plain oral tablet.
Pharmacotherapeutic Group of (API) Potassium-competitive acid blocker.
Proposed Pack size 7’s, 14’s, 28’s & 30’s tablets
The status in reference regulatory authorities Takecab Tablets (Vonoprazan) is registered and
being marketed by Takeda Pharmaceuticals
(Approved by Pharmaceuticals and Medical
Devices Agency, Japan).
For generic drugs (me-too status) Vonozan Tablet 10mg by M/s Getz Pharma
Private Limited, Reg. No. 108570
GMP status of the Finished product New GMP Certificate granted on 28/05/2022.
manufacturer Tablet (General & Antibiotic), Capsule (General
& Cephalosporin), Dry Powder for Suspension
(General Antibiotic &Cephalosporin), Oral
Liquid (Syrup) (Non-Antibiotic & Antibiotic),
Cream / Ointment / Lotion (Non-Antibiotic &
Antibiotic & Steroids), Eye & Ear Drops (Non-
Antibiotic & Antibiotic & Steroids), Liquid
Enema (General), Sachet (General), Small
Volume Lyophilized Injectable (Non-Antibiotic,
Antibiotic), Gel & Tablet (Hormones) sections
approved.
Name and address of API manufacturer. M/s Yibin Hongguang Pharmaceutical Co.,
Ltd.Luolong country
NanxiDistrict,YibinCity,SichuanProvince,
PC-644100,China
procedures and its verification / validation, batch
Module III (Drug Substance) Monograph of Vonoprazan Fumarate is present
is as per In-house (Manufacturer’s)
controls, tests for related substances (Individual
impurity, total impurity), specifications,
months
months
Batches: (MS103201-190501, MS103201-
190502, MS103201-190503)
and buffer medium) and its validation studies,
Takecab Tablets (Vonoprazan) is registered and
being marketed by Takeda Pharmaceuticals, by
Identification, Dissolution and Assay).
that is Vonozan Tablet 10mg (Vonoprazan) by
Getz Pharma Private Limited, in Acid media (pH
1.2) & Phosphate Buffer (pH 4.5 & 6.8). The
specificity.
Manufacturer of API M/s Yibin Hongguang Pharmaceutical Co., Ltd.
Luolong country NanxiDistrict,YibinCity,SichuanProvince,
PC-644100,China
API Lot No. MS103201-210501
Description of Pack
Alu-Alu blister 7’s, 14’s, 28’s & 30’s tablets packed in unit carton.
Batch No. 451DS01 451DS02 451DS03
No. of Batches 03
1. Reference of previous approval of applications Submitted.
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate issued by Yibin
API manufacturer issued by concerned Association of Pharmaceutical Industry, Yibin,
regulatory authority of country of origin. Sichuan, China valid till 16/03/2025. Firm has
also provided copy of Drug Manufacturing
License ( valid up to(29-12-2025) issued by
Sichuan Medical products Administration ,which
is varied online.
3. Documents for the procurement of API with Copy of invoice no MC120210531-004 dated 31-
approval from DRAP (in case of import). 05-2021 duly attested by Assistant Director,

chromatograms,
etc.
Observations Firms response vide dairy NO.29738 dated
20-08-2022
2.3.S.1.3 • Melting point test is not conducted • The melting point of innovator product API is
whereas melting point of 194.8 degree Celsius, we have revised our
innovator product API is 194.8 API testing specifications same has been
degree Celsius. attached in Annexure-A and also incorporated
melting point test specifications on it for
future QC release.
• We also conducted melting point test on
retention sample of Vonoprazan Fumarate
API and found satisfactory results as mention
• Pka value is missing below
Serial No. Test Observed Results
Specifications
01 Melting Point Sample 1= 194.9°C.
194.8 °C. Sample 2 = 194.8°C
Sample 3 = 194.9°C
Average = 194.8°C
• The Pka value is 9.6

3.2.P.5.1 • The finished product release • Vonoprazan is a highly soluble drug
specification for dissolution test substance, based on ICH Q6A, which states
is mentioned as not less than Q of that the drug substance should be considered
labelled amount of Vonoprazan highly soluble if it meets following
in 30 minutes, whereas the conditions:
innovator product has dissolution • “The dissolution profile of all strengths of the
parameter of achieving Q within dosage form should be rapid i.e. Dissolution
15 minutes, clarification is > 80% in 15 minutes at pH 1.2, 4.0 & 6.8.”
needed. • Vonotab tablet 10 mg & 20mg as well as the
reference product “Vonoget Tablets” by Getz
Pharma releases more than 85% in all three
mediums within 15 minutes at 50 RPM
which is reflected by comparative
dissolution profile studies.
• As per USP general chapter<1092>
“Dissolution Procedure: Development and
Validation”, Immediate release dosage form
should release within 30 to 60 minutes.
3.2.P.8.3 Therefore, we select the lowest time point i.e.
30 minutes for dissolution.
• The firm has provided stability • Moreover Reference to the decision of
data up to three months’ timeline “Minutes of 294th Meeting of Registration
for both accelerated and real time Board” case of Reference product “Vonoget
stability data. The stability study 20mg Tablet” by M/s Getz Pharma(Pvt) Ltd.
data up to 6 months’ time line is was approved having time interval for
required for both accelerated and dissolution test at 30 minutes.(Attached in
real-time stability data. Annexure-B)
• We have already submitted 06 months
stability data on 11th March 2022, attached is
the copy of receiving for ready reference.
submitted in the registration applicationRegistration Board further decided that,
• Registration Board further decided that, Firm shall submit revised COA after setting
dissolution test specification as NLT 85 % within 15 minutes before issuance of
of applicable fee of 7500/=for pre-registration variation, as per notification No.F.7-
11/2012-B&A/DRAP dated 07- 05-2021.
Case No 3 : Export Facilitation (out of que) Cases: (Human, Local, Form-5F)
M/s M/s AGP Limited, B-23-C, S.I.T.E., Karachi, Pakistan
In compliance to the above decision M/s AGP Limited, B-23-C, S.I.T.E., Karachi, have achieved
benchmark of more than 100,000 USD and submitted their applications for priority consideration
including following applications
319. Name, address of Applicant / Marketing M/s AGP Limited, B-23-C, S.I.T.E., Karachi,
Authorization Holder Pakistan
Name, address of Manufacturing site. M/s AGP Limited, B-23-C, S.I.T.E., Karachi,
Pakistan
☐ Importer
giver)
☐ Export sale
Details of fee submitted PKR 30,000/-: 68187020357dated 26/11/2021
The proposed proprietary name / brand name Vonocid 10mg Tablet
Pharmaceutical ingredient (API) per unit Vonoprazan (as Vonoprazan Fumarate)… 10mg
Pharmaceutical form of applied drug Film coated Table
Pharmacotherapeutic Group of (API) Potassium competitive acid blocker
Reference to Finished product specifications In-House
Proposed unit price As per DRAP Approved Price
The status in reference regulatory authorities Tekecab Tablet 10mg M/s Takeda
Pharmaceutical Company Limited, PMDA
Approved.
For generic drugs (me-too status) Vonozan 10mg Tablet by M/s Getz Pharma
Pakistan (Pvt) (Reg no. 108570)
GMP status of the Finished product New GMP granted on 17/06/2021.
manufacturer
Name and address of API manufacturer. M/s Jiangxi Synergy Pharmaceutical Co., Ltd,
Jiangxi Fengxin Industrial Park , Jiangxi
Province, China
submitted.
Module III (Drug Substance) Monograph of Vonoprazan Fumarate is
according to Manufacturer’s Specification. The
months
months
Batches: (20190801BD, 20190802BD and
20190803BD)
Takecab 10mg Tablet by Takeda Pharmaceutical
Company Limited by performing quality tests
that is Takecab 10mg Tablet by Takeda
Pharmaceutical Company Limited in Acid media
(pH 1.0-1.2) , Acetate buffer (pH 4.5) &
specificty.
Manufacturer of API M/s Jiangxi Synergy Pharmaceutical Co., Ltd, Jiangxi Fengxin
Industrial Park , Jiangxi Province, China
Description of Pack
Alu/PVC/PVDC blister of 3 x 10’s tablets
Time Period Real time: 12 months (will be continued till shelf life of 24 months)
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. TR-616 TR-617 TR-618
No. of Batches 03
1. Reference of previous approval of applications Empag Tablets 25mg by M/s AGP Limited,
with stability study data of the firm (if any) Karachi. Approved in Minutes of 295th
Meeting of Registration Board (8-11 June,
2020)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate issued by Jiangxi API
API manufacturer issued by concerned Engineering Technology Research Centre valid
regulatory authority of country of origin. till 11/03/2025. Firm has also submitted copy of
Drug Manufacturing license No. GAN20160125
valid up to 26-11-2025 ,issued by Jiangxi
Provincial Medical Product Administration
,China.
3. Documents for the procurement of API with • License no. 1573 dated 09/06/2020 to import
approval from DRAP (in case of import). APIs Vonoprazan Fumarate for the purpose of
• Invoice no. JXSG200409 , dated 09-06-2020
chromatograms,
etc.
5. Compliance Record of HPLC software 21CFR Compliant
6. Record of Digital data logger for temperature Provided
S. Firms Response vide dairy No.31363
Section Observations
No. dated 02-11-2022
• The physical description of API is • “White to almost white powder” is a
provided as, “White to almost white general physical description given by
powder”, whereas the innovator API manufacturer while material is
product literature mentions as “white white to almost white crystalline
to almost white crystals or crystalline powder.
powder”. Clarification is needed DMF reflects crystal characteristics of
where the applied API is crystalline API:
powder or amorphous powder and Crystal Analysis / Polymorphism “The
01. 2.3.S.1.3 justification in case of amorphous polymorphic form of our product is
powder. stable confirm with X-ray spectra”.
• Melting point test is not conducted Melting point is a physical test, not
whereas melting point of innovator available in the manufacturer
product API is 194.8 degree Celsius. specification; hence not performed.
• pKa value is not provided. • PKa value is updated in the Product
Development Report (copy
enclosed)
• Certificate of analysis of imported • Fumaric acid test for fumarate salt; its
API Batch No. BD2009003 quantitation is for information
conducted by M/s AGP Limited has purpose only which is performed in
mentioned assay of Fumaric Acid as 2nd analysis report (Batch No.
3.2.S.4.4
02. 25% and the value is taken from 20190803BD), which is already
.1
CoA of API manufacturer as provided in 3.2.S.4.4.1. (copy
mentioned on CoA. Clarification is enclosed)
required regarding skipping of test
of Fumaric Acid.
Firm has mentioned batch formula It is a typographical error, the correct
with composition and label claim as label claim is as under:
under: Vonoprazan (as Fumarate) ... 10 mg
Vonoprazan fumarate……….. 10
mg, Revised section 3.2.P.3.2 is enclosed
03. 3.2.P.3.2
Whereas the innovator is
Vonoprazan (as Fumarate) ...... 10
mg
needed.
• The finished product dissolution test • It is a typographical error, the revised
parameter are mentioned as Product Development Report and
apparatus’s; i.e. USP type 2 (paddle) Process Validation Protocols are
with speed of paddle 75 rpm and time enclosed.
04. 3.2.P.5.1 15 minutes. Where are the process
validation protocol and
Pharmaceutical Development Report
mentioning analytical specifications
for dissolution of film coated tablet
mentions limit as “Not less than • Parameters are not available in FDA
80%Q in 30 minutes”. dissolution database or in any
• Clarification/ revision is needed assessment report.
regarding the dissolution time limit Time & rpm referred from WHO CDP
also speed of paddle as innovator guideline of very rapidly dissolving
product dissolution parameter product; as no less than 85% of the
mentioned paddle speed of 50 rpm. labelled amount of the API dissolves in
15 minutes at 37°C using a paddle
apparatus at 75 rpm in a volume of
900mL.
• Firm is required to submit • Stability Data Sheets of trial
Stability Data Sheet of trial batches are already provided in
batches of finished product as per section 3.2.P.8.3. Data Sheets are
the format given in CTD guidance also enclosed for your reference.
document. • Compliance Record of HPLC
• Compliance record of HPLC software 21CFR is enclosed. Audit
software 21CFR & audit trail trail report is mentioned on each
report on product testing. chromatogram. (Sample is enclosed
05. 3.2.P.8.3
for your reference).
already provided in section
3.2.P.8.3. Data is enclosed for your
reference.
variation, i-e 30000/= as per notification No.F.7-11/2012-B&A/DRAP dated 07- 05-2021
for correction in label claim.
• Firm shall submit revised COA after setting dissolution test specification as NLT 85 %
within 15 minutes before issuance of registration letter
320. Name, address of Applicant / Marketing M/s AGP Limited, B-23-C, S.I.T.E., Karachi,
Authorization Holder Pakistan
Name, address of Manufacturing site. M/s AGP Limited, B-23-C, S.I.T.E., Karachi,
Pakistan
☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand name Vonocid 20mg Tablet
Pharmaceutical ingredient (API) per unit Vonoprazan (as Vonoprazan Fumarate)… 20mg
Pharmacotherapeutic Group of (API) Potassium competitive acid blocker
Proposed unit price As per DRAP Approved Price
The status in reference regulatory authorities Tekecab Tablet 20mg M/s Takeda
Pharmaceutical Company Limited, PMDA
Approved.
For generic drugs (me-too status) Vonozan 20mg Tablet by M/s Getz Pharma
Pakistan (Pvt) (Reg no. 108571)
GMP status of the Finished product New GMP granted on 17/06/2021
manufacturer
Name and address of API manufacturer. M/s Jiangxi Synergy Pharmaceutical Co., Ltd,
Jiangxi Fengxin Industrial Park , Jiangxi
Province, China
submitted.
Module III (Drug Substance) Monograph of Vonoprazan Fumarate is
according to Manufacturer’s Specification. The
months
months
Batches: (20190801BD, 20190802BD and
20190803BD)
Takecab 20mg Tablet by Takeda Pharmaceutical
Company Limited by performing quality tests
that is Takecab 20mg Tablet by Takeda
Pharmaceutical Company Limited in Acid media
(pH 1.0-1.2) , Acetate buffer (pH 4.5) &
specificty.
Manufacturer of API M/s Jiangxi Synergy Pharmaceutical Co., Ltd, Jiangxi Fengxin
Industrial Park , Jiangxi Province, China
Description of Pack
Alu/PVC/PVDC blister of 3 x 10’s tablets
Time Period Real time: 12 months (will be continued till shelf life of 24 months )
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
No. of Batches 03
1. Reference of previous approval of applications Empag Tablets 25mg by M/s AGP Limited,
with stability study data of the firm (if any) Karachi. Approved in Minutes of 295th
Meeting of Registration Board (8-11 June,
2020)
,China.
3. Documents for the procurement of API with • License no. 1573 dated 09/06/2020 to import
approval from DRAP (in case of import). APIs Vonoprazan Fumarate for the purpose of
• Invoice no. JXSG200409 , dated 09-06-2020
chromatograms,
etc.
5. Compliance Record of HPLC software 21CFR Compliant
S.
Section Observations AGP Reply
No.
• The physical description of API is • “White to almost white powder” is a
provided as, “White to almost white general physical description given by
powder”, whereas the innovator API manufacturer while material is
product literature mentions as white to almost white crystalline
“white to almost white crystals or powder.
crystalline powder”. Clarification is DMF reflects crystal characteristics of
needed where the applied API is API:
crystalline powder or amorphous Crystal Analysis / Polymorphism “The
01. 2.3.S.1.3 powder and justification in case of polymorphic form of our product is
amorphous powder. stable confirm with X-ray spectra”.
• Melting point test is not conducted Melting point is a physical test, not
whereas melting point of innovator available in the manufacturer
product API is 194.8 degree Celsius. specification; hence not performed.
• pKa value is not provided. • PKa value is updated in the Product
Development Report (copy
enclosed)
• Certificate of analysis of imported • Fumaric acid test for fumarate salt; its
API Batch No. BD2009003 quantitation is for information
conducted by M/s AGP Limited has purpose only which is performed in
mentioned assay of Fumaric Acid 2nd analysis report (Batch No.
3.2.S.4.4.
02. as 25% and the value is taken from 20190803BD), which is already
1
CoA of API manufacturer as provided in 3.2.S.4.4.1. (copy
mentioned on CoA. Clarification is enclosed)
required regarding skipping of test
of Fumaric Acid.
Firm has mentioned batch formula It is a typographical error, the correct
with composition and label claim as label claim is as under:
under: Vonoprazan (as Fumarate) ... 20 mg
Vonoprazan fumarate…... 20 mg,
03. 3.2.P.3.2 Whereas the innovator is Revised section 3.2.P.3.2 is enclosed
Vonoprazan (as Fumarate) ...... 20
mg
needed.
• The finished product dissolution • It is a typographical error, the revised
test parameter are mentioned as Product Development Report and
apparatus’s; i.e. USP type 2 Process Validation Protocols are
(paddle) with speed of paddle 75 enclosed.
rpm and time 15 minutes. Where
are the process validation protocol
and Pharmaceutical Development
Report mentioning analytical
specifications for dissolution of
film coated tablet mentions limit as
04. 3.2.P.5.1
“Not less than 80%Q in 30 • Parameters are not available in FDA
minutes”. dissolution database or in any
• Clarification/ revision is needed assessment report.
regarding the dissolution time limit Time & rpm referred from WHO CDP
also speed of paddle as innovator guideline of very rapidly dissolving
product dissolution parameter product; as no less than 85% of the
mentioned paddle speed of 50 rpm. labelled amount of the API dissolves in
15 minutes at 37°C using a paddle
apparatus at 75 rpm in a volume of
900mL.
• Firm is required to submit • Stability Data Sheets of trial
Stability Data Sheet of trial batches are already provided in
batches of finished product as section 3.2.P.8.3. Data Sheets are
per the format given in CTD also enclosed for your reference.
guidance document.
• Compliance record of HPLC software 21CFR is enclosed. Audit
software 21CFR & audit trail trail report is mentioned on each
report on product testing. chromatogram. (Sample is
05. 3.2.P.8.3
enclosed for your reference).

already provided in section
3.2.P.8.3. Data is enclosed for your
reference.
variation, i-e 30000/= as per notification No.F.7-11/2012-B&A/DRAP dated 07- 05-2021
for correction in label claim.
within 15 minutes before issuance of registration letter
Case No 4: Export Facilitation (out of que) Cases: (Human, Local, Form-5F)
M/s Pharmedic Laboratories (Pvt.) Ltd.Lahore
In compliance to the above decision M/s Pharmedic Laboratories (Pvt.) Ltd.Lahore have achieved
benchmark of more than 100,000 USD and submitted their applications for priority consideration
including following applications
321. Name, address of Applicant / Marketing Name: Pharmedic Laboratories (Pvt.) Ltd.
Authorization Holder Address: 16km Multan Road, Lahore-Pakistan
Contact details: Tel: +92 42 37511861-65
Fax: (042) 37511396-37510498
Email: info@pharmedic.com
Name, address of Manufacturing site. Name: Pharmedic Laboratories (Pvt.) Ltd.
Address: 16km Multan Road, Lahore-Pakistan
Fax: (042) 37511396-37510498
☐ Importer
giver)
☐ Export sale
Details of fee submitted PKR 75000, Slip No. 844595626 dated
02/06/2022
The proposed proprietary name / brand name Vonov 10mg Tablet
Pharmaceutical ingredient (API) per unit Vonoprazan fumarate equivalent to
Vonoprazan………….10mg
Pharmaceutical form of applied drug white colored, round shaped, biconvex film
coated tablets with both sides plain.
Pharmacotherapeutic Group of (API) Antacids, Antireflux Agents & Antiulcerants
Belongs to the class of potassium-competitive
acid blocker.
Reference to Finished product specifications In-House (Innovator Specification)
The status in reference regulatory authorities Takecab Tablets 10 mg, Takeda Pharmaceutical
Company Limited, Japan.
For generic drugs (me-too status) Vonozan 10mg Tablet by M/s Getz Pharma, Reg.
No. 108570
GMP status of the Finished product Last GMP was granted on 09/06/2020
manufacturer GMP is in Renewal Process
Name and address of API manufacturer. Name:
Jiangxi Synergy Pharmaceutical Co., Ltd.
Address: Jiangxi Fengxin Industrial Park,
Fengxin, Jiangxi Province, P.R.China
submitted.
Module III (Drug Substance) Official monograph of Vonoprazan fumarate is
present in USP and BP. The firm as submitted
process and controls, Test for Impurities,
substance
months
months
Batches: (VON-10/TR001, VON10-TR002,
VON10-TR003)
Vonozan 10mg tablet by Getz Pharma (Pvt) Ltd.
by performing quality tests (Identification,
Assay, Dissolution, Uniformity of dosage form).
that is Vonozan 10mg tablet by Getz Pharma
(Pvt) Ltd.….. in Acid media (pH 1.0-1.2) &
product including Specificity, linearity, reproducibility
accuracy, precision (repeatability), Limit of
Detection, Limit of Quantification, Robustness.
Manufacturer of API Jiangxi Synergy Pharmaceutical Co., Ltd
Description of Pack
Real Time: 0, 3, 6, 9, 12, 18, 24(Months)
Batch No. VON-10/TR001 VON-10/TR002 VON-10/TR003
No. of Batches 03
1. Reference of previous approval of applications The firm has not submitted any document.
,China.
3. Documents for the procurement of API with • Copy of letter No.15439/2021DRAP-AD
approval from DRAP (in case of import). (I&E) dated 14/10/2021 is submitted wherein
the permission to import Vonoprazan Fumarate
for the purpose of test/analysis and stability
studies is granted.
chromatograms,
etc.

Sr. Section# Observation Firms Response vide dairy No .2703
# (PEC DRAP) dated 3-11-2022
1. 2.3.S.1.3 • The physical description of API is We, Jiangxi Synergy Pharmaceutical
provided as, “White to almost Co., Ltd., hereby certify that as for our
white powder”, whereas the product Vonoprazan Fumarate, the
innovator product literature appearance is white to almost white
mentions as “white to almost white crystalline powder
crystals or crystalline powder”. Reference attached
Clarification is needs where the
applied API is crystalline powder
powder. Melting point：199.5~199.8℃
• Melting point test is not conducted (Both API manufacture and Finished
whereas melting point of product manufacturer has conducted
innovator product API is 194.8 Identification tests of Vonoprazan
degree Celsius. Fumarate (Batch No. 202110801BD)
• Pka value is not provided. through HPLC and FTIR
pKa：6.74±0.50
2. 3.2.S.4.4 • Certificate of analysis of imported • Regarding testing of fumaric acid, it was
.1 API Batch Conducted by M/s performed on raw material and its value
Pharmedic Labortories has is 25% but due to some clerical mistake
mentioned assay of Fumaric acid / typographical error in COA, it was
as 25 % and the value is taken from interpreted as taken from supplier COA.
COA of API manufacturer as (Reference attached).
mentioned on COA. Clarification
is required regarding skipping of
test of Fumaric acid
3. 3.2.P.5.1 • Justification of specification of Firm is using in-house alternative
Content uniformity test as 85 -115 method
(%) in light of compendia
requirements. (See USP general
chapter requirements of content
uniformity test).
• The Finished product release
specification for dissolution test is Firm has submitted revised batch release
mentioned as not less than Q of specifications for dissolution test as
labelled amount of Vonoprazan in NLT 80 % (Q) within 15 minutes.
30 minutes , whereas the innovator
product has dissolution parameter
of achieving Q within 15 minutes ,
4. 3.2.S.7.3 • Stability study data sheet of 3 Submitted
batches of API (Vonoprazan
Fumarate) conducted and
displayed by API manufacturer.
5. 3.2.P.8.3 • The firm has provided stability Attached
data up to three months’ timeline
for both accelerated and real time
stability data, the stability study
required for both accelerated and Currently we are not conducting
real time stability study data. impurity/stress testing at method
• Stability study data does not development and validation/verification
mentioned testing of content report and as uniformity of content is not
uniformity test and impurities a stability indicating parameter (trial
/degradation product test , batches) and as it was performed at the
Clarification is needed. time of trial manufacturing so this may
not be required at each stability testing
point.
• Firm shall submit revised COA after conducting content uniformity test as per USP
general chapter <905>UNIFORMITY OF DOSAGE UNITS, before issuance of
registration
of applicable fee for pre-registration variation ,i-e 7500/=as per notification No.F.7-
11/2012-B&A/DRAP dated 07- 05-2021 for correction of finished product specifications.
322. Name, address of Applicant / Marketing Name: Pharmedic Laboratories (Pvt.) Ltd.
Authorization Holder Address: 16km Multan Road, Lahore-Pakistan
Fax: (042) 37511396-37510498
Name, address of Manufacturing site. Name: Pharmedic Laboratories (Pvt.) Ltd.
Address: 16km Multan Road, Lahore-Pakistan
Fax: (042) 37511396-37510498
☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand name Vonov 20mg Tablet
Pharmaceutical ingredient (API) per unit Vonoprazan fumarate equivalent to
Vonoprazan………….20mg
Pharmaceutical form of applied drug white colored, round shaped, biconvex film
coated tablets with both sides plain.
Pharmacotherapeutic Group of (API) Antacids, Antireflux Agents & Antiulcerants
Belongs to the class of potassium-competitive
acid blocker.
Reference to Finished product specifications In-House (Innovator Specification)
The status in reference regulatory authorities Takecab Tablets 20 mg, Takeda Pharmaceutical
Company Limited, Japan.
For generic drugs (me-too status) Vonozan 20mg Tablet by M/s Getz Pharma, Reg.
No. 108571
GMP status of the Finished product Last GMP was granted on 09/06/2020
manufacturer GMP is in Renewal Process
Name and address of API manufacturer. Name:
Jiangxi Synergy Pharmaceutical Co., Ltd.
Address: Jiangxi Fengxin Industrial Park,
Fengxin, Jiangxi Province, P.R.China
submitted.
Module III (Drug Substance) Official monograph of Vonoprazan fumarate is
present in USP and BP. The firm as submitted
process and controls, Test for Impurities,
substance
months
months
Batches: (VON-20/TR001, VON20-TR002,
VON20-TR003)
Vonozan 20mg tablet by Getz Pharma (Pvt) Ltd.
by performing quality tests (Identification,
Assay, Dissolution, Uniformity of dosage form).
that is Vonozan 20mg tablet by Getz Pharma
(Pvt) Ltd.….. in Acid media (pH 1.0-1.2) &
product including Specificity, linearity, reproducibility
accuracy, precision (repeatability), Limit of
Detection, Limit of Quantification, Robustness.
Manufacturer of API Jiangxi Synergy Pharmaceutical Co., Ltd
Description of Pack
Real Time: 0, 3, 6, 9, 12, 18, 24(Months)
Batch No. VON-20/TR001 VON-20/TR002 VON-20/TR003
No. of Batches 03
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No.2020002 issued by
API manufacturer issued by concerned Jiangxi API Engineering Technology Research
regulatory authority of country of origin. Centre valid till 11/03/2025. Firm has also
submitted copy of Drug Manufacturing license
No. GAN20160125 valid up to 26-11-2025
,issued by Jiangxi Provincial Medical Product
Administration ,China.
3. Documents for the procurement of API with Copy of letter No.15439/2021DRAP-AD (I&E)
approval from DRAP (in case of import). dated 14/10/2021 is submitted wherein the
permission to import Vonoprazan Fumarate for
the purpose of test/analysis and stability studies
is granted.
chromatograms,
etc.
Sr. Section# Observation Firms Response vide dairy No .2703

# (PEC DRAP) dated 3-11-2022
1. 2.3.S.1.3 • The physical description of API is We, Jiangxi Synergy Pharmaceutical
provided as, “White to almost Co., Ltd., hereby certify that as for our
white powder”, whereas the product Vonoprazan Fumarate, the
innovator product literature appearance is white to almost white
mentions as “white to almost white crystalline powder
crystals or crystalline powder”. Reference attached
Clarification is needs where the
applied API is crystalline powder
powder. Melting point：199.5~199.8℃
• Melting point test is not conducted (Both API manufacture and Finished
whereas melting point of product manufacturer has conducted
innovator product API is 194.8 Identification tests of Vonoprazan
degree Celsius. Fumarate (Batch No. 202110801BD)
• Pka value is not provided. through HPLC and FTIR
pKa：6.74±0.50
2. 3.2.S.4.4 • Certificate of analysis of imported • Regarding testing of fumaric acid, it was
.1 API Batch Conducted by M/s performed on raw material and its value
Paramedic Labortories has is 25% but due to some clerical mistake
mentioned assay of Fumaric acid / typographical error in COA, it was
as 25 % and the value is taken from interpreted as taken from supplier COA.
COA of API manufacturer as (Reference attached).
mentioned on COA. Clarification
is required regarding skipping of
test of Fumaric acid
3. 3.2.P.5.1 • Justification of specification of Firm is using in-house alternative
Content uniformity test as 85 -115 method
(%) in light of compendia
requirements. (See USP general
chapter requirements of content
uniformity test).
• The Finished product release
specification for dissolution test is Firm has submitted revised batch release
mentioned as not less than Q of specifications for dissolution test as
labelled amount of Vonoprazan in NLT 80 % (Q) within 15 minutes
30 minutes , whereas the innovator
product has dissolution parameter
of achieving Q within 15 minutes ,
4. 3.2.S.7.3 • Stability study data sheet of 3 Submitted
batches of API (Vonoprazan
Fumarate) conducted and
displayed by API manufacturer.
5. 3.2.P.8.3 • The firm has provided stability Attached
data up to three months’ timeline
for both accelerated and real time
required for both accelerated and Currently we are not conducting
real time stability study data. impurity/stress testing at method
• Stability study data does not development and validation/verification
mentioned testing of content report and as uniformity of content is not
uniformity test and impurities a stability indicating parameter (trial
/degradation product test , batches) and as it was performed at the
Clarification is needed. time of trial manufacturing so this may
not be required at each stability testing
point.

• Firm shall submit revised COA after conducting content uniformity test as per USP
general chapter <905>UNIFORMITY OF DOSAGE UNITS, before issuance of
registration
of applicable fee for pre-registration variation ,i-e 7500/=as per notification No.F.7-
11/2012-B&A/DRAP dated 07- 05-2021 for correction of finished product specifications.
Case No 05: Caliph Pharmaceuticals (Pvt) Ltd. Plot No 17, Special Industrial Zone (EPZ),
Risalpur
In light of the Decision made in Authority Meeting dated 15th September 2022” as under
“This has reference to the aforementioned subject and decision made in the last Authority
Meeting
dated 15th September 2022, to ensure continuous supply of Paracetamol Tablets and to
incentivize
manufacturer thereon in form of out-of-queue consideration of application of 1 generic (Me-too)
molecule on manufacturing and immediate distribution of atleast 15,000 packs of Paracetamol
Tablets
with pack size of 200 Tablets.:
It is therefore submitted that in line with the decision of DRAP Authority, M/s Caliph Pharmaceuticals
(Pvt) Ltd. Plot No 17, Special Industrial Zone (EPZ), Risalpur have immediately manufactured and
distributed 18,000 packs of their already registered product Cepmol 500mg Tablet (Paracetamol). The
details of the manufactured batches of Cepmol 500mg Tablet is as under:
Sr. No Batch No. Batch Size Packs Mfg. Date Exp. Date
1 2010 400,000 2000 09-2022 08-2024
2 2017 800,000 4000 09-2022 08-2024
3 2032 800,000 4000 09-2022 08-2024
4 2033 400,000 2000 09-2022 08-2024
5 2034 400,000 2000 09-2022 08-2024
6 2047 800,000 4000 10-2022 09-2024
Total 3,600,000 18,000
Accordigly following 01 molecule (Vonoprazan Tablet) is considered out of queue as per the decision
of DRAP Authority. Details of our applications of this molecule is as under:
Sr. No Brand Name Composition Date of R&I
submission in DRAP
1 Vonocal 10mg Each Film Coated Tablet Contains: 12-05-2022
Tablet Vonoprazan Fumarate Eq. to
Vonoprazan…10mg
2 Vonocal 20mg Each Film Coated Tablet Contains: 12-05-2022
Tablet Vonoprazan Fumarate Eq. to
Vonoprazan…20mg
Following documents are also attached.
a) Copy of Batch Manufacturing Record of 6 batches of Cepmol 500mg Tablet.
b) Copy of Invoices and delivery challan as evidence of distribution of the manufactured stock.
c) Copy of R&I receiving of our applied product i.e. Vonocal 10mg Tablet and Vonocal 20mg
Tablet.
323. Name, address of Applicant / Marketing Caliph Pharmaceuticals (Pvt) Ltd. Plot No 17,
Name, address of Manufacturing site. Caliph Pharmaceuticals (Pvt) Ltd. Plot No 17,
☐ Importer
giver)
☐ Export sale
Details of fee submitted PKR 30,000/-:Slip No.5146720245 dated 26-4-
2022
The proposed proprietary name / brand name VONOCAL 10MG TABLET
Pharmaceutical ingredient (API) per unit Vonoprazan fumarate eq to Vonoprazan
………10mg
Pharmaceutical form of applied drug White colored, round, biconvex, film-coated
tablets with bisectional line on one side
containing Vonoprazan Fumarate as active
ingredient
Pharmacotherapeutic Group of (API) Proton pump inhibitors
Reference to Finished product specifications Innovator’s
The status in reference regulatory authorities Takecab 10mg Tablet by Takeda Pharmaceutical
Company Limited, PMDA Japan Approved.
For generic drugs (me-too status) Vonozan Tablet 10mg of Getz Pharma
GMP status of the Finished product GMP certificate granted on 02-03-2021.
manufacturer Inspection was conducted on 02-03-2021
Name and address of API manufacturer. Ami Lifesciences Pvt. Ltd., Block No.82/B,
ECP Road, At & Post. Karakhadi, Tal - Padra,
Karakhadi - 391 450, Vadodara, Gujarat, India.
submitted.
substance
months
months
Batches: (VPF/RD/31800819,
VPF/RD/31810819, VPF/RD/31820819)
Module-III (Drug Product): The firm has submitted detail of product
development, manufacturers, description of
verification studies, batch analysis and
drug product.
dissolution profile established against the innovators product
Takecab 10mg Tablet manufactured by Takeda
Pharmaceutical Company Limited by performing
quality tests (Identification, Assay, Dissolution,
Uniformity of dosage form etc).
CDP has been performed against the innovators
product Takecab 10mg Tablet manufactured by
Takeda Pharmaceutical Company Limited in
Acid media (pH 1.2), Acetate buffer (pH 4.5) &
Analytical method validation/verification of Method verification studies have submitted for
product API and method validation studies for finished
product.
Manufacturer of API Ami Lifesciences Pvt. Ltd., Block No.82/B, ECP Road, At & Post.
Karakhadi, Tal - Padra, Karakhadi - 391 450, Vadodara, Gujarat,
India.
API Lot No. VPF/30020821M
Description of Pack
Alu-Alu blister
Batch No. T-001 T-002 T-003
No. of Batches 03
1. Reference of previous approval of applications Product specific inspection for Dexcal
with stability study data of the firm (if any) (Dexlansoprazole) 30mg and 60mg Capsule
was conducted by the panel on 1st June, 2021
and the report was presented in 308th meeting
of Registration Board held on 21-22nd June
2021.
API manufacturer issued by concerned by Food and Drug Control Administration
regulatory authority of country of origin. Gujrat State India valid till 24/04/2022.
3. Documents for the procurement of API with • ADC attested invoice is submitted cleared on
approval from DRAP (in case of import). 09-09-2021. 0.5Kg Vonoprazan Fumarate is
imported from Ami Life Sciences
4. Data of stability batches will be supported by Complete record of testing of all batches along
attested respective documents like with chromatograms and raw data sheets is
chromatograms, attached.
etc.
5. Compliance Record of HPLC software 21CFR Not available
6. Record of Digital data logger for temperature Not Submitted.
Sr. Section# Observation Firms response vide dairy No.
# 29608 dated 18-10-22 and 31566
dated 03-11-2022
1. 3.2.S.1.3 Melting point of Vonoprazan API It was a typographical error in our
is mentioned as 206 degrees dossier, as identified by your good
Celsius whereas melting point of office we have also rechecked and
innovator product API identified our mistake. the melting
(Vonoprazan) is 194.8 degree point of Vonoprazan fumarate API is
Celsius. Clarification is needed. 194.8.
2. 3.2.S.4.4 Batch Analysis report of imported Or specification of the drug substance
API Batch No .VPF/3002082 includes the test of appearance,
conducted locally by Finished solubility, identification, loss on
product manufacturer does not drying, assay of Vonoprazan and
mention LOD test, water content assay of Fumaric acid we have also
test , Residual on ignition , heavy performed all these on the imported lot
metal test , as well as impurity tests of API and we are also mentioned in
and residual solvent test , moreover the COA report. For rest of the tests
the COA does not bear signature on we rely on the results of API
analysist and QC in charge. manufacturer as our practice, signed
COA is attached
3. 3.2.P.1 The submitted master formulation The recommended concentration of
of finished tablet mentioned 5.2 % Croscarmellose sodium is 2—5 %,
of Croscarmellose Sodium( USP) however during formulation
per tablet , and method used is development trials we get ideal
direct compression , which is more dissolution using 5.2 %
than the recommended quantity of Croscarmellose sodium. the
Croscarmellose sodium per tablet , dissolution results in CDP studies also
Justification is required. evident the release profile of the drug
,however before commercial
manufacturing after importing bulk
quantity of API we will again perform
some trials and make some minor
adjustment in the formulation and will
only use recommended percentage of
Croscarmellose sodium .
4. 3.2.P.5.3 Analytical method validation study We have performed system suitability
report is incomplete with reference test and robustness during the
System suitability test, Specificity validation studies. The signed copy of
test and Robustness .Moreover the complete validation sstudies is
provided report is not signed by attached.
analyst and QC In charge.
5. 3.2.P.8.3 • The firm has provided stability • Stability study data up to 6-month
data up to three months’ timeline time for accelerated and real time
for both accelerated and real time stability study is submitted.
• Compliance Record of HPLC • Audit trial report for the product
software 21CFR & audit trail testing for vonocol tablets is not
reports on product testing is available since the HPLC system was
missing, which is required. not 21 CFR complaint.
temperature and humidity • Digital record of data logger of both
monitoring of stability chambers chamber is provided.
missing , which is required.
• Registration Board directed the firm to optimize the formulation for quantity of excipients
within permissible limits as per Handbook of Pharmaceutical excipients/recommendations
of reference regulatoruy authorities, for commercial batches.
• Registration Board further decided that registration letter wil be issued upon submission
of complete analytical method validation studies report including test of specificity and
robusteness.
324. Name, address of Applicant / Marketing Caliph Pharmaceuticals (Pvt) Ltd. Plot No 17,
Name, address of Manufacturing site. Caliph Pharmaceuticals (Pvt) Ltd. Plot No 17,
☐ Importer
giver)
☐ Export sale
Details of fee submitted PKR 30,000/-: Slip No.89634230928 dated 26-
04-2022
The proposed proprietary name / brand name VONOCAL 20MG TABLET
Pharmaceutical ingredient (API) per unit Vonoprazan fumarate eq to vonoprazan
………20mg
Pharmaceutical form of applied drug White colored, round, biconvex, film-coated
tablets with bisectional line on one side
containing Vonoprazan Fumarate as active
ingredient
Pharmacotherapeutic Group of (API) Proton pump inhibitors
Reference to Finished product specifications Innovator’s
The status in reference regulatory authorities Takecab 20mg Tablet by Takeda Pharmaceutical
Company Limited, PMDA Japan Approved.
For generic drugs (me-too status) Vonozan Tablet 20mg of Getz Pharma
GMP status of the Finished product GMP certificate granted on 02-03-2021.
manufacturer Inspection was conducted on 02-03-2021
Name and address of API manufacturer. Ami Lifesciences Pvt. Ltd., Block No.82/B,
ECP Road, At & Post. Karakhadi, Tal - Padra,
Karakhadi - 391 450, Vadodara, Gujarat, India.
submitted.
substance
months
months
Batches: (VPF/RD/31800819,
VPF/RD/31810819, VPF/RD/31820819)
Module-III (Drug Product): The firm has submitted detail of product
development, manufacturers, description of
drug product.
dissolution profile established against the innovators product
Takecab 20mg Tablet manufactured by Takeda
Pharmaceutical Company Limited by performing
quality tests (Identification, Assay, Dissolution,
Uniformity of dosage form etc).
CDP has been performed against the innovators
product Takecab 20mg Tablet manufactured by
Takeda Pharmaceutical Company Limited in
Acid media (pH 1.2), Acetate buffer (pH 4.5) &
Analytical method validation/verification of Method verification studies have submitted for
product API and method validation studies for finished
product.
Manufacturer of API Ami Lifesciences Pvt. Ltd., Block No.82/B, ECP Road, At & Post.
Karakhadi, Tal - Padra, Karakhadi - 391 450, Vadodara, Gujarat,
India.
API Lot No. VPF/30020821M
Description of Pack
Alu-Alu blister
Batch No. T-001 T-002 T-003
No. of Batches 03
1. Reference of previous approval of applications Product specific inspection for Dexcal
with stability study data of the firm (if any) (Dexlansoprazole) 30mg and 60mg Capsule
was conducted by the panel on 1st June, 2021
and the report was presented in 308th meeting
of Registration Board held on 21-22nd June
2021.
API manufacturer issued by concerned by Food and Drug Control Administration
regulatory authority of country of origin. Gujrat State India valid till 24/04/2022.
3. Documents for the procurement of API with • ADC attested invoice is submitted cleared on
approval from DRAP (in case of import). 09-09-2021. 0.5Kg Vonoprazan Fumarate is
imported from Ami Life Sciences
4. Data of stability batches will be supported by Complete record of testing of all batches along
attested respective documents like with chromatograms and raw data sheets is
chromatograms, attached.
etc.
5. Compliance Record of HPLC software 21CFR Not available
6. Record of Digital data logger for temperature Not submiited.
Sr. Section# Observation Firms response vide dairy No. Firms resp
# 29608 dated 18-10-22 and 31566 29608 date
dated 03-11-2022 diary No
1. 3.2.S.1.3 Melting point of Vonoprazan API It was a typographical error in our
is mentioned as 206 degrees dossier, as identified by your good
Celsius whereas melting point of office we have also rechecked and
innovator product API identified our mistake. the melting
(Vonoprazan) is 194.8 degree point of Vonoprazan fumarate API is
Celsius. Clarification is needed. 194.8.
2. 3.2.S.4.4 Batch Analysis report of imported Or specification of the drug substance
API Batch No .VPF/3002082 includes the test of appearance,
conducted locally by Finished solubility, identification, loss on
product manufacturer does not drying, assay of Vonoprazan and
mention LOD test, water content assay of Fumaric acid we have also
test , Residual on ignition , heavy performed all these on the imported lot
metal test , as well as impurity tests of API and we are also mentioned in
and residual solvent test , moreover the COA report. For rest of the tests
the COA does not bear signature on we rely on the results of API
analysist and QC in charge. manufacturer as our practice, signed
COA is attached
3. 3.2.P.1 The submitted master formulation The recommended concentration of
of finished tablet mentioned 5.2 % Croscarmellose sodium is 2—5 %,
of Croscarmellose Sodium( USP) however during formulation
per tablet , and method used is development trails we get ideal
direct compression , which is more dissolution using 5.2 %
than the recommended quantity of Croscarmellose sodium. the
Croscarmellose sodium per tablet , dissolution results in CDP studies also
Justification is required. evident the release profile of the drug
,however before commercial
manufacturing after importing bulk
quantity of API we will again perform
some trials and make some minor
adjustment in the formulation and will
only use recommended percentage of
Croscarmellose sodium .
4. 3.2.P.5.3 Analytical method validation study We have performed system suitability
report is incomplete with reference test and robustness during the
System suitability test, Specificity validation studies. The signed copy of
test and Robustness .Moreover the complete validation 9studies is
provided report is not signed by attached.
analyst and QC In charge.
5. 3.2.P.8.3 • The firm has provided stability • Stability study data up to 6-month • Stability stu
data up to three months’ timeline time for accelerated and real time time for acc
for both accelerated and real time stability study is submitted. stability stud
• Compliance Record of HPLC • Audit trial report for the product
software 21CFR & audit trail testing for vonocol tablets is not
reports on product testing is available since the HPLC system was
missing, which is required. not 21 CFR complaint.
temperature and humidity • Digital record of data logger of both
monitoring of stability chambers chamber is provided.
missing , which is required.
• The Registration Board directed the firm to optimize the formulation for quantity of
excipients within permissible limits as per Handbook of Pharmaceutical
excipients/recommendations of reference regulatoruy authorities, for commercial batches.
• Registration Board further decided that registration letter wil be issued upon submission
of complete analytical method validation studies report including test of specificity and
robusteness.
B: Human(New) (Local) FORM-5 F
325. Name, address of Applicant / Marketing M/s Novamed Pharmaceuticals(Pvt.) Ltd

Authorization Holder Lahore
Name, address of Manufacturing site. M/s Novamed Pharmaceuticals(Pvt.) Ltd ., 28km

Ferozepur Road Lahore

☐ Importer
☐ Export sale
Empozin 10mg
name
Strength / concentration of drug of Active Each Film coated Tablet Contains:
Pharmaceutical ingredient (API) per unit Empagliflozin……………10mg
Pharmacotherapeutic Group of (API) (1)Empagliflozin is an inhibitor of SGLT2
Proposed Pack size 10’s, 14’s 20’s, 28’s.
The status in reference regulatory authorities Jardiance 10mg tablet
Boehringer Ingelheim Limited USA
For generic drugs (me-too status) Empator 10mg by Horizon Pharma

Reg no. 098822
GMP status of the Finished product License granted on 08/04/2006 and renewed on
manufacturer 08/04/2021 General tablet section approved and
GMP certificate on 31/08/2021.
Name and address of API manufacturer. (1) Empagliflozin;
API manufacturer Name:Jiangsu Yong'an
Pharmacy CompanyLimited Address: No.18
,237 Proviancial, Road ,Economic Development
Zone, Huai’an Jiangsu,China,
impurity D, G & related substances (impurity A &
unspecified), specifications, analytical procedures
drug substance
months
months
Emphagliflozin
Batches:(130701,130702,130801)
Jardiance 10mg tablet by performing quality
tests (Identification, Assay, Dissolution, pH).
CDP was applicable and has been submitted.
specificity, robustness and Limit of
Quantification.
Manufacturer of API Empagliflozin;
Name:Jiangsu Yong'an Pharmacy Company Limited
Address: No.18 ,237 Proviancial, Road ,Economic Development Zone,
Huai’an Jiangsu,China,
API Lot No. Emphagliflozin: 4500-202003001
Description of Pack Alu-PVC blisters, each containing White colour, Oval shaped biconvex, film
(Container closure coated tablets having breaking line on upper side & lower side is plain.
system) One side of blister is printed with labeling specification.
After primary packing blister is packed in specific hard card unit carton along
with Patient information leaflet
Batch No. RD/PR21-
RD/PR21-058/T1/S2 RD/PR21-058/T1/S3
058/T1/S1
No. of Batches 03
1. Reference of previous approval of The firm has submitted copy of Last inspection
applications with stability study data of the Report conducted on 24/01/2018 (Daclatasvir),
firm (if any) 06/03/2017 (Sofosbuvir)
2. Approval of API/ DML/GMP certificate of Emphagliflozin: Copy of GMP certificate issued
API manufacturer issued by concerned by CFDA,People’s republic of china HUAI’AN
regulatory authority of country of origin. JIANGSU valid till 14/01/2024
3. Documents for the procurement of API with Emphagliflozin AD Attested invoice
approval from DRAP (in case of import). ZY20052001G/W Dated.09/06/2020 and

chromatograms,
etc.
testing
Remarks Of Evaluator:
Sr. Section Observation
# #
1. 1.1.5 Legible copy of GMP certificate of manufacturing Site of API
,(Empagliflozin).
2. 3.2.S.2.1 The system suitability conditions set my API manufacturer is detection of API
through HPLC with UV detector at 224 nm , same as innovator product , i-e
Jardiance whereas under 3.2.S.4.3 validation /verification of analytical
procedure by drug product manufacturer significantly varied , including UV
detection at 205 nm, which needs clarification.
3. 3.2.S.2.1 Content Uniformity test conducted to establish pharmaceutical equivalence
during comparative dissolution ,L1 value is not calculated to meet the
specifications as per Pharmacopeia General chapter for content uniformity
testing.
4. 3.2.P.2.2 • Justification for setting of Dissolution time specification while conducting
.1 Comparative dissolution with reference product was set as 30 minutes
whereas the innovator product has mentioned specification for dissolution
time as 15 minutes.
• In comparative dissolution the RPM for USP type 2 ( Paddle Apparatus) is
set to be 50 RPM whereas innovator Tab Jardiance has conducted same at
75 RPM which needs clarification.
5. 3.2.P.5.3 • The specificity test for conducting validation of analytical method is
conducted without the presence of other components like impurities,
excipients and matrix compounds which is necessary to establish the
specificity of testing method.
• Intermediate precision is conducting without comparing the result of
separate or different analyst on same apparatus.
6. 3.2.P.8.3 • Stability data of three batches for 6th month for both accelerated and real
time stability is missing which is required.
• Content uniformity test for Empagliflpzin 10 mg is not mentioned in
finished product specification nor it is part of stability batches data / COA,
which needs clarification.
• Documents for the procurement of API with approval from DRAP (in case
of import).
Decision: Registration Board has deferred the case for submission of the reply for above
cited shortcomings within six (6) months.
326. Name, address of Applicant / Marketing M/s Helix Pharma (Pvt)., Ltd.
Authorization Holder A-56, S.I.T.E, Karachi.
Name, address of Manufacturing site. Same as above
☐ Importer
giver)
☐ Export sale
Dy. No. and date of submission Dy. No.31528 dated : 15/11/2021
Details of fee submitted PKR 30,000/- Slip No. 90975244 dated
02/09/2021
The proposed proprietary name / brand name YOFERA TABLETS 10mg
Pharmaceutical ingredient (API) per unit Empagliflozin…………10 mg
(Innovator’s Specification)
Pharmaceutical form of applied drug Tablet (Oral) ; Yellow round slight biconvex
film coated tablets
Pharmacotherapeutic Group of (API) Anti-Diabetics ; sodium-glucose co-transporter
2 (SGLT2) inhibitors (Drugs used in diabetes,
Other blood glucose lowering drugs, excl.
insulins)
Reference to Finished product specifications Helix Pharma follow the Innovator’s
Specification
The status in reference regulatory authorities Jardiance tablet 10mg by M/s Boehringer
Ingelheim Pharmaceuticals, Inc., USFDA
Approved.
For generic drugs (me-too status) Diampa Tablets 10mg by M/s Getz Pharma;
Empozin Tablets 10mg by M/s Macter ; Xenglu
Tablets 10mg by M/s Hilton ; Empaa Tablets
10mg by M/s Horizon
GMP status of the Finished product DML # 000030; Renewal on 24.04.2022
GMP routine inspection conducted on
09/02/2022
GMP Certificate issued on 25/01/2021 on basis
of inspection conducted on 29/10/2020 ;valid
upto 28/10/2022
Name and address of API manufacturer. M/s CHIFENG ARKER
PHARMACEUTICAL CO.LTD CHINA ;
Address: No. 8 Mysun Street, Hongshan
Economic Development Zone, Chifeng , Inner
Mongolia, China
submitted.
Module III (Drug Substance) In-house monograph of Empagliflozin. The
impurity A,B & C & related substances,
substance
months
months
Batches: (EGF20151201, EGF20151202,
EGF20151203)
product.
Diampa Tablets 25mg ; Batch # 016FB5
manufactured by Getz Pharma Pakistan by
brand that is Diampa Tablets 10mg
manufactured by Getz Pharma Pakistan in Acid
media (pH 1.2 HCl & pH 4.5 Acetic Acid) &
Analytical method validation/verification of Method Validation studies have submitted
specificity etc.
Manufacturer of API M/s CHIFENG ARKER PHARMACEUTICAL CO.LTD CHINA ;
Address: No. 8 Mysun Street, Hongshan Economic Development
Zone, Chifeng , Inner Mongolia, China
Description of Pack
Alu-Alu blister packed in unit carton (2 x7’s)
No. of Batches 03
1. Reference of previous approval of applications The firm has referred the DRB 312th meeting
with stability study data of the firm (if any) Minutes for approval of new molecule “ZALPO
(VONOPRAZAN) TABLETS 10mg & 20mg
which were approved on basis of onsite
inspection for another product of same dosage
form.
The said DRB Meeting minutes has mentioned
that:
The HPLC is 21CFR Compliant.
Audit trail on the testing reports of “ZALPO
Tablet 10mg & 20mg” were available.
Adequate monitoring & control are available
for stability chamber. The firm has installed
software for recording temperature/Humidity of
the chamber (for real time stability software
V5.7T Thermo, India & Accelerated Stability
studies, software is Logit Chrt; Technoman;
Pakistan) & the data can been verified for 01
year.
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. NM20150062
manufacturer issued by concerned regulatory issued by CFDA
3. Documents for the procurement of API with The firm submitted the Form-6 & invoice dully
approval from DRAP (in case of import). attested by AD DRAP Karachi on 19/05/2020 ,
confirming the import of API “Empagliflozin”
Qty: 560 gms ; Batch # D89-200401
attested respective documents like of
chromatograms, all batches along with chromatograms, raw
Raw data sheets, COA, summary data sheets data
etc. sheets, COA and summary data sheets.
5. Compliance Record of HPLC software 21CFR Firm has submitted complete compliance record
& audit trail reports on product testing of HPLC software 21CFR & audit trail reports
on product testing.
6. Record of Digital data logger for temperature submitted

Sr. Sectio Observation Firms response vide dairy
# n No.30445 dated 27-10-2022
1. 1.1.5 GMP certificate of manufacturing site Submitted.
of API is required ,i-e M/s CHIFENG
ARKER PHARMACEUTICAL
CO.LTD CHINA ; Address: No. 8
Mysun Street, Hongshan Economic
Development Zone, Chifeng , Inner
Mongolia, China
2. 3.2.S.4 Under the heading of “Control of Drug Please note that the selection of
Substance”, the manufacturer wavelength was carried out by
mentioned HPLC with UV detector preparing empagliflozin standard
assay of product at 225 nm wave length solution and all process impurities in
, however the assay of applied product diluent at the specification limit. The
is conducted at 230 nm whereas the prepared solution injected into the
innovator product Jardiance (USFDA) HPLC system with PDA detector and
is conducted at 224 nm , clarification in spectra was recorded. The
this regard is required. chromophoric structure of all the
compounds almost similar and all
compounds were found to have
optimum UV absorption at 230 nm.
Therefore, the 230 nm wavelength
was chosen for the study and
quantification of Empagliflozin and
its impurities.
We also conducted the test by using
both wave lengths i.e : 225nm &
230nm & found no difference in
retention time (Working sheet along
with chromatograms are enclosed
herewith for your ready reference)
3. 3.2.P.5 Dissolution specification of applied Revised submitted, Internal control
.1 product does not mentioned the time of limit for dissolution as NLT 80 %
dissolution for Finished product for within 30 minutes While for shelf life
batch release specification. limit as NLT 80% within 15 minutes.
4. 3.2.P.2 Justification for setting of Dissolution Please note that we have conducted
.2.1 time specification while conducting Comparative Dissolution Profile
Comparative dissolution with reference (CDP) up to 30minutes as per our
product was set as 30 minutes whereas internal control specification whereas
the innovator product has mentioned the set product batch release
specification for dissolution time as 15 dissolution specification is NLT 80%
minutes. in 15minutes
5. 3.2.P.8 Documents for the procurement of API Submitted
import).
within 15 minutes before issuance of registration letter.
variation ,i-e 7500/=as per notification No.F.7-11/2012-B&A/DRAP dated 07- 05-2021 for
correction of finished product specifications.
327. Name, address of Applicant / Marketing M/s Helix Pharma (Pvt)., Ltd.
Authorization Holder A-56, S.I.T.E, Karachi.
Name, address of Manufacturing site. Same as above
☐ Importer
giver)
☐ Export sale
Dy. No. and date of submission Dy. No.31527 dated : 15/11/2021
The proposed proprietary name / brand name YOFERA TAB LETS 25mg
Pharmaceutical ingredient (API) per unit Empagliflozin…………25 mg
(Innovator’s Specification)
Pharmaceutical form of applied drug Tablet (Oral) ; Yellow elliptical slight biconvex
film coated tablets with H logo on one side and
break line on other side.
Pharmacotherapeutic Group of (API) Anti-Diabetics ; sodium-glucose co-transporter
2 (SGLT2) inhibitors (Drugs used in diabetes,
Other blood glucose lowering drugs, excl.
insulins)
Reference to Finished product specifications Helix Pharma follow the Innovator’s
Specification
The status in reference regulatory authorities Jardiance tablet 25mg by M/s Boehringer
Ingelheim Pharmaceuticals, Inc., USFDA
Approved.
For generic drugs (me-too status) Diampa Tablets 25mg by M/s Getz Pharma;
Empozin Tablets 25mg by M/s Macter ; Xenglu
Tablets 25mg by M/s Hilton ; Empaa Tablets
25mg by M/s Horizon
GMP status of the Finished product DML # 000030 ;Renewal on 24.04.2022
GMP routine inspection conducted on
09/02/2022
GMP Certificate issued on 25/01/2021 on basis
of inspection conducted on 29/10/2020 ;valid
upto 28/10/2022
Name and address of API manufacturer. M/s CHIFENG ARKER
PHARMACEUTICAL CO.LTD CHINA ;
Address: No. 8 Mysun Street, Hongshan
Economic Development Zone, Chifeng , Inner
Mongolia, China
submitted.
Module III (Drug Substance) In-house monograph of Empagliflozin. The
impurity A,B & C & related substances,
substance
months
months
Batches: (EGF20151201, EGF20151202,
EGF20151203)
product.
Diampa Tablets 25mg ; Batch # 019FB6
manufactured by Getz Pharma Pakistan by
brand that is Diampa Tablets 25mg
manufactured by Getz Pharma Pakistan in Acid
media (pH 1.2 HCl & pH 4.5 Acetic Acid) &
Analytical method validation/verification of Method Validation studies have submitted
specificity etc.
Manufacturer of API M/s CHIFENG ARKER PHARMACEUTICAL CO.LTD CHINA ;
Address: No. 8 Mysun Street, Hongshan Economic Development
Zone, Chifeng , Inner Mongolia, China
Description of Pack
Alu-Alu blister packed in unit carton (2 x7’s)
No. of Batches 03
1. Reference of previous approval of applications The firm has referred the DRB 312th meeting
with stability study data of the firm (if any) Minutes for approval of new molecule “ZALPO
(VONOPRAZAN) TABLETS 10mg & 20mg
which were approved on basis of onsite
inspection for another product of same dosage
form.
The said DRB Meeting minutes has mentioned
that:
The HPLC is 21CFR Compliant.
Audit trail on the testing reports of “ZALPO
Tablet 10mg & 20mg” were available.
Adequate monitoring & control are available
for stability chamber. The firm has installed
software for recording temperature/Humidity of
the chamber (for real time stability software
V5.7T Thermo, India & Accelerated Stability
studies, software is Logit Chrt; Technoman;
Pakistan) & the data can been verified for 01
year.
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. NM20150062
manufacturer issued by concerned regulatory issued by CFDA
3. Documents for the procurement of API with The firm submitted the Form-6 & invoice dully
approval from DRAP (in case of import). attested by AD DRAP Karachi on 19/05/2020 ,
confirming the import of API “Empagliflozin”
Qty: 560 gms ; Batch # D89-200401
attested respective documents like of
chromatograms, all batches along with chromatograms, raw
Raw data sheets, COA, summary data sheets data
etc. sheets, COA and summary data sheets.
5. Compliance Record of HPLC software 21CFR Firm has submitted complete compliance record
& audit trail reports on product testing of HPLC software 21CFR & audit trail reports
on product testing.
6. Record of Digital data logger for temperature submitted

Sr. Sectio Observation Firms response vide dairy
# n No.30445 dated 27-10-2022
1. 1.1.5 GMP certificate of manufacturing site Submitted.
of API is required ,i-e M/s CHIFENG
ARKER PHARMACEUTICAL
CO.LTD CHINA ; Address: No. 8
Mysun Street, Hongshan Economic
Development Zone, Chifeng , Inner
Mongolia, China
2. 3.2.S.4 Under the heading of “Control of Drug Please note that the selection of
Substance”, the manufacturer wavelength was carried out by
mentioned HPLC with UV detector preparing empagliflozin standard
assay of product at 225 nm wave length solution and all process impurities in
, however the assay of applied product diluent at the specification limit. The
is conducted at 230 nm whereas the prepared solution injected into the
innovator product Jardiance (USFDA) HPLC system with PDA detector and
is conducted at 224 nm , clarification in spectra was recorded. The
this regard is required. chromophoric structure of all the
compounds almost similar and all
compounds were found to have
optimum UV absorption at 230 nm.
Therefore, the 230 nm wavelength
was chosen for the study and
quantification of Empagliflozin and
its impurities.
We also conducted the test by using
both wave lengths i.e : 225nm &
230nm & found no difference in
retention time (Working sheet along
with chromatograms are enclosed
herewith for your ready reference)
3. 3.2.P.5 Dissolution specification of applied Revised submitted, Internal control
.1 product does not mentioned the time of limit for dissolution as NLT 80 %
dissolution for Finished product for within 30 minutes While for shelf life
batch release specification. limit as NLT 80% within 15 minutes.
4. 3.2.P.2 Justification for setting of Dissolution Please note that we have conducted
.2.1 time specification while conducting Comparative Dissolution Profile
Comparative dissolution with reference (CDP) up to 30minutes as per our
product was set as 30 minutes whereas internal control specification whereas
the innovator product has mentioned the set product batch release
specification for dissolution time as 15 dissolution specification is NLT 80%
minutes. in 15minutes
5. 3.2.P.8 Documents for the procurement of API Submitted
import).
within 15 minutes before issuance of registration letter.
variation ,i-e 7500/=as per notification No.F.7-11/2012-B&A/DRAP dated 07- 05-2021 for
correction of finished product specifications.
328. Name, address of Applicant / Marketing M/s Allmed (Pvt.) Ltd
Authorization Holder Plot# 590 Sunder Industrial Estate Raiwind
Road- Lahore
Name, address of Manufacturing site. M/ s Allmed (Pvt.) Ltd
Plot# 590 Sunder Industrial Estate Raiwind
Road- Lahore
☐ Importer
giver)
☐ Export sale
Dy. No. and date of submission Dy. No. 27423-A dated 04/10/2021
Details of fee submitted PKR 20,000/-: Slip No.49001593033 dated
13/04/2021
PKR 10,000/- Slip No .93361876 dated
08/07/2021
The proposed proprietary name / brand name Sopra-Praz D 30mg Capsule
Strength / concentration of drug of Active Each Capsule Contains:
Pharmaceutical ingredient (API) per unit Dual Delayed release pellets of
Dexlansoprazole equivalent to
Dexlansoprazole: ------- 30mg
Pharmaceutical form of applied drug Hard gelatin Capsule filled with white to off
white dual delayed release pellets.
Pharmacotherapeutic Group of (API) PPIs (Proton Pump Inhibitors)
Reference to Finished product specifications Manufacturer Specifications
The status in reference regulatory authorities Dexilant 30mg Capsule
Takeda Pharmaceuticals USA Inc (Innovator)
For generic drugs (me-too status) Razodex 30mg Capsule by Getz Pharma
Reg. # 086976
GMP status of the Finished product GMP inspection was conducted on 11/06/2021
manufacturer and report satisfactory.
Capsule (General & General Antibiotic) section
approved.
Name and address of API manufacturer. Vision Pharmaceuticals
Tel: (92-51) 4493587-88-89-90,
Fax: (92-51) 4493591
Email: contact@visionpharmapk.com Web:
www.visionpharmapk.com
submitted.
Module III (Drug Substance) Monograph of Dexlansoprazole is not present in
Pharmacopoeia. The firm has submitted detail
of nomenclature, structure, general properties,
controls, tests for impurities/related substances
(Sulphone Impurity Sulphide Impurity Total
months
months
Batches: (SP-T40, SP-T41, SP-T42)
product.
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence has been
dissolution profile established against Razodex 30mg Capsule (B #
039C47) by Getz Pharma by performing quality
tests (Identification, Dissolution,
Disintegration, Assay, Total Impurity,
Microbial contamination).
that is Razodex 30mg Capsule (B # 039C47) by
Getz Pharma in Acid media (pH 1.0-1.2) & (pH
5.5 & 7). The values for f1 and f2 are in the
acceptable range.
specificity.
Manufacturer of API Vision Pharmaceuticals
Plot No. 22-23, Industrial Triangle, Kahuta Road, Islamabad- Pakistan
API Lot No. DLP569
Description of Pack
Frequency Accelerated: 0, 1, 2, 3, 4, 6 (Months)
Real Time: 0, 1, 2, 3, 4, 6 (Months)
Batch No. SP-T40 SP-T41 SP-T42
Batch Size 2500 Capsule 2500 Capsule 2500 Capsule
No. of Batches 03
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate F. 3-26/20 19-Addl.
API manufacturer issued by concerned Dir. (QA & LT-I) issued by DRAP valid till
regulatory authority of country of origin. 10/02/2022.
3. Documents for the procurement of API with • Purchase order No PO-9-20-7 is submitted.
approval from DRAP (in case of import). Purchased from Vision Pharmaceuticals,
Islamabad- Pakistan hence DRAP approval is
not required.
etc.
5. Compliance Record of HPLC software 21CFR
Submitted
6. Record of Digital data logger for temperature
and humidity monitoring of stability chambers Submitted
Sr. Section# Observation
#
1. 1.3.5. Evidence of approval of manufacturing facility / Approved Section from
Licensing Authority
2. 3.2.S.2.3 Firm has not mentioned sucrose as part of their master formulation for
manufacturing control of inactive material however firm has mentioned
sucrose in section 2.3.S.2.5, i-e Manufacturing process development. which
needs clarification.
3. 3.2.S.2.6 The specification of dual release pellets at enteric coating stage is
mentioned as soluble at 6.7 PH , whereas QA release specification for IPQC
is mentioned as dissolution at P.H.7, which needs clarification.
4. 3.2.S.4.4 • The submitted COA of source of API, (Dexlansoprazole) M/s Everest
Organics Limited, India, has mentioned Identification /Assay through
Chiral HPLC, however same is not depicted through COA of API by local
pellets manufacturer. i-e M/s Vision pharmaceuticals, Islamabad.
• Dexlansoprazole is a racemic enantiomer of Lansoprazole, Optical
rotation test is performed by API manufacturer , however as per COA of
Pellets , same is not performed by Pellet manufacturer , as well as finished
product manufacturer which needs clarification.
5. 3.2.S.7 • API (Pellet) Manufacturer has not mentioned/conducted degradation
product test while conducting stability study data of API(pellets) , which
6. 3.2.P.2.2.1 • Finished product manufacturer has submitted comparative dissolution
Profile performance with Capsule Razodex ,Getz Pharma , However firm
has not submitted non Model dependent Cohen’s F2( Similarity factor)
calculation to establish comparable dissolution with comparator .which
Decision: Registration Board has deferred the case for submission of the reply for abve cited
shortcomings within six (6) months.
329. Name, address of Applicant / Marketing M/s Allmed (Pvt.) Ltd
Authorization Holder Plot# 590 Sunder Industrial Estate Raiwind
Road- Lahore
Name, address of Manufacturing site. M/ s Allmed (Pvt.) Ltd
Plot# 590 Sunder Industrial Estate Raiwind
Road- Lahore
☐ Importer
giver)
☐ Export sale
Dy. No. and date of submission Dy. No. 27423-B dated 04/10/2021
Details of fee submitted PKR 30,000/-: dated 20,000/- 13/04/2021
10,000/- 08/07/2021
The proposed proprietary name / brand name Sopra-Praz D 60mg Capsule
Pharmaceutical ingredient (API) per unit Dual Delayed release pellets of
Dexlansoprazole equivalent to
Dexlansoprazole: ------- 60mg
Pharmaceutical form of applied drug Hard gelatin Capsule filled with white to off
white dual delayed release pellets.
Pharmacotherapeutic Group of (API) PPIs (Proton Pump Inhibitors)
Reference to Finished product specifications Manufacturer Specifications
The status in reference regulatory authorities Dexilant 60mg Capsule
Takeda Pharmaceuticals USA Inc (Innovator)
For generic drugs (me-too status) Razodex 60mg Capsule by Getz Pharma
Reg. # 086977
GMP status of the Finished product GMP inspection was conducted on 11/06/2021
manufacturer and report satisfactory.
Capsule (General & General Antibiotic) section
approved.
Name and address of API manufacturer. Vision Pharmaceuticals
Tel: (92-51) 4493587-88-89-90,
Fax: (92-51) 4493591
Email: contact@visionpharmapk.com Web:
www.visionpharmapk.com
submitted.
Module III (Drug Substance) Monograph of Dexlansoprazole is not present in
Pharmacopoeia. The firm has submitted detail
of nomenclature, structure, general properties,
controls, tests for impurities/related substances
(Sulphone Impurity Sulphide Impurity Total
months
months
Batches: (SP-T37, SP-T38, SP-T39)
product.
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence has been
Razodex 60mg Capsule (B # 038C48) by Getz
(Identification, Dissolution, Disintegration,
Assay, Total Impurity, Microbial
contamination).
that is Razodex 60mg Capsule (B # 038C48) by
Getz Pharma in Acid media (pH 1.0-1.2) & (pH
5.5 & 7). The values for f1 and f2 are in the
acceptable range.
specificity.
Manufacturer of API Vision Pharmaceuticals
Plot No. 22-23, Industrial Triangle, Kahuta Road, Islamabad- Pakistan
API Lot No. DLP569
Description of Pack
Real Time: 0, 1, 2, 3, 4, 6 (Months)
Batch No. SP-T37 SP-T38 SP-T39
Batch Size 2500 Capsule 2500 Capsule 2500 Capsule
No. of Batches 03
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate F. 3-26/20 19-Addl.
API manufacturer issued by concerned Dir. (QA & LT-I) issued by DRAP valid till
regulatory authority of country of origin. 10/02/2022.
3. Documents for the procurement of API with • Purchase order No PO-9-20-7 is submitted.
Purchased from Vision Pharmaceuticals,
Islamabad- Pakistan hence DRAP approval is
not required.
etc.
5. Compliance Record of HPLC software 21CFR
Submitted
6. Record of Digital data logger for temperature
and humidity monitoring of stability chambers Submitted
Sr. Section# Observation
#
1. 1.3.5. Evidence of approval of manufacturing facility / Approved Section from
Licensing
Authority
2. 3.2.S.2.3 Firm has not mentioned sucrose as part of their master formulation for
manufacturing control of inactive material however firm has mentioned
sucrose in section 2.3.S.2.5, i-e Manufacturing process development. which
3. 3.2.S.2.6 The specification of dual release pellets at enteric coating stage is
mentioned as soluble at 6.7 PH , whereas QA release specification for IPQC
is mentioned as dissolution at P.H.7, which needs clarification.
4. 3.2.S.4.4 • The submitted COA of source of API, (Dexlansoprazole) M/s Everest
Organics Limited, India, has mentioned Identification /Assay through
Chiral HPLC, however same is not depicted through COA of API by local
pellets manufacturer. i-e M/s Vision pharmaceuticals, Islamabad.
• Dexlansoprazole is a racemic enantiomer of Lansoprazole, Optical
rotation test is performed by API manufacturer , however as per COA of
Pellets , same is not performed by Pellet manufacturer , as well as finished
product manufacturer which needs clarification.
5. 3.2.S.7 • API (Pellet) Manufacturer has not mentioned/conducted degradation
product test while conducting stability study data of API(pellets) , which
6. 3.2.P.2.2.1 • Finished product manufacturer has submitted comparative dissolution
Profile performance with Capsule Razodex ,Getz Pharma , However firm
has not submitted non Model dependent Cohen’s F2( Similarity factor)
calculation to establish comparable dissolution with comparator .which
Decision: Registration Board has deferred the case for submission of the reply for above cited
Human (Import) Form 5 F (New)
330. Name, address of Applicant / Importer M/s. Novartis Pharma (Pakistan) Limited,
15 West Wharf, Karachi, Pakistan
Address: Novartis Pharma (Pakistan) Limited,
15 West Wharf, Dockyard Road, Karachi,
Pakistan.
Address of Godown: C-21, SITE, Karachi.
Validity: 12-3-2023.
Renewal: Not Applicable
Name and address of marketing authorization Sandoz Pharmaceuticals AG, 6343 Risch,
holder (abroad) Schweiz.
Name, address of manufacturer(s) Sandoz GmbH, Biochemiestrasse 10, 6250
Kundl Austria
Name of exporting country Switzerland
Detail of certificates attached (CoPP, Free- Firm has submitted original & legalized CoPP
sale certificate, GMP certificate) certificate (No. 20003187) dated 29-06-2020
issued by Swissmedic for
Piperacillin/Tazobactam Sandoz 2.25g. The
CoPP confirms that this product is on the
market in exporting country as well as GMP
compliant status of manufacturer.
Details of letter of authorization / sole agency Firm has submitted original & legalized letter
agreement of Authorization/ Sole Agency Agreement.
This letter specifies that the manufacturer
appoints M/s Novartis Pharma (Pakistan) Ltd.,
Karachi. to register and market the product as
Sole Agent in Pakistan.
☒ Importer
giver)
☐ Export sale
purpose only
Dy. No. and date of submission Dy. No31767 .Dated: 10-08-2021
Details of fee submitted PKR 150,000/-: slip No.373355053674 dated
10-08-2021
The proposed proprietary name / brand name Piperacillin/Tazobactam Sandoz 4.5g Powder
for solution for Injection/Infusion
Pharmaceutical ingredient (API) per unit Piperacillin sodium..........4.168g
(Corresponding to 4000mg of Piperacillin)
Tazobactam sodium .......... 0.53638g
(Corresponding to 500mg of Tazobactam)
Pharmaceutical form of applied drug Powder for Solution for Injection/Infusion
Pharmacotherapeutic Group of (API) Antibacterial for systemic use
Reference to Finished product specifications Manufacturer’s Specs
Proposed Pack size 1 Vial powder for solution for
injection/infusion
Proposed unit price Proposed MRP per pack shall be furnished
later
The status in reference regulatory authorities Product has been approved in many stringent
regulatory authorities such as Belgium, France,
Spain, Switzerland, etc.
For generic drugs (me-too status) Tacip by M/S Macter International Limited
(Reg # 073632), Tazomax by M/S Mediceena
Pharma (Pvt.) Ltd. (Reg. # 052920), Mepnem
by M/S English Pharmaceuticals Industries
(Reg. # 064557), etc.
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO-QOS-
PD template. Firm has provided the
summarized information related to
Name, address of drug substance manufacturer Tazobactam
Shandong Anxin Pharmaceutical Co., Ltd.
Piperacillin:
Phase 1: North China Pharmaceutical Group
Semisyntech Co., Ltd and Zhuhai United
Laboratories Co.,Ltd.
Phase 2: Shandong Anxin Pharmaceutical Co.,
Ltd.
Module-III Drug Substance: Firm has submitted detailed drug substance
Stability Studies of Drug Substance Piperacillin:
(Conditions & duration of Stability studies) Firm has submitted stability study data of
Piperacillin under the 25 ± 2°C / 60%RH ± 5
% for Accelerated and 2°C to 8°C for
accelerated condition. The stability study for
long term data up to 24 months is provided.
Tazobactam Sodium:
The stability data of Tazobactam Sodium
under Long-term stability condition: 25°C ±
2°C 60 % ± 5 % rel. humidity and Accelerated
stability condition: 40°C ± 2°C 75 % ± 5 % rel.
humidity was provided. The Stability Study for
Pharmaceutical Equivalence and Comparative Firm has provided data of comparative Studies.
Dissolution Profile Comparative studies (physicochemical and
impurities profiles) have been performed with
originator products (i.e. Tazocin®,
Tazocilline® 2.25g and 4.5 g, respectively)
currently marketed in several European
countries (BE, GB, NO, FR)and the Sandoz
product. The results clearly indicate that all
European originator products tested and the
Sandoz product are essentially similar.
Analytical method validation/verification of Firm has submitted analytical method
product validation studies for the applied product.
Container closure system of the drug product Injection Vial Glass Type III, Infusion bottle
Glass Type II, infusion bottle stopper, injection
vial stopper, flip-off boarded cap
Stability study data of drug product, shelf life Firm has submitted stability study data for 24
and storage conditions months long-term stability conditions of
30°C/75% RH. Stability was also monitored at
accelerated storage condition at 40 °C/75% RH
for 6 months.
Evaluation by PEC:
# #
1. 1.1.5 Provided GMP certificate of manufacturing site is expired on 25-11-2021,
provide valid and embassy attested GMP certificate of manufacturer.
2. 2.3. S.4 Under the heading of “Control of Drug Substance”, the manufacturer
mentioned is M/s Qilu Tianhe whereas per 2.3.S.2 the manufacturer of drug
substance i-e Piperacillin, /Tazobactam/Sterile Lyophilized mixture of
Piperacillin Tazobactam (8:1)1 is mentioned as M/s Shandong Axin Co. ltd.
Clarification is needed.
3. 3.2. S The Substance part of CTD dossier is submitted for Piperacillin and
tazobactam as separate powder substances whereas the actual substance to be
shipped to manufacturer M/s Sandoz Austria, is Piperacillin: Tazobactam
lyophilized bulk powder (8:1), therefore S Part with all its components of
Piperacillin: Tazobactam Lyophilized bulk powder in fixed ration 8:1 is
required.
4. 3.2.S.1.1 Active Substance Master File of Qilu Tianhe Pharmaceutical Co, Ltd is
provided for Piperacillin and Tazobactum which needs clarification.
5. 3.2.P.3.4 Control of Intermediate Piperacillin: Tazobactam Intermediate 8:1 is provided
by Qilu Tianhe whereas manufacturing site is mentioned as M/s Shandong
Axin Pharmaceutical Co.Ltd.
6. 3.2.P.3.4 COA of Sodium bicarbonate is issued by Qilu Tianhe, which needs
clarification.
7. 3.2.P.3.4 COA for water for Injection is issued by Qilu Tianhe, which needs
clarification.
8. 3.2.P.4.3 Validation of Analytical procedure for Assay of Piperacillin and related
substance is conducted by M/s Qilu Pharmaceutical Cot Ltd and transferred to
Qilu Tianhe, however no such transfer document is provided in this regard.
9. 3.2.S.4.5 Firm is intended to testing specification of Piperacillin monohydrate as per
Ph.Eur however the chromatographic conditions submitted for assay is varied
form Pharmacopoeia specifications.
10. 3.2.P.3.4 COA of Piperacillin Tazobactam Sterile bulk Powder is issued by Qilu Tianhe,
which needs clarification
11. 3.2.P.2.1 Justification for not conducting complete Pharmacopoeial tests as required to
.1 establish pharmaceutical equivalence. (Dissolving time, Particulate matter,
Clarity of reconstituted solution etc.)
12. 3.2. The stability data provided for accelerated study for batch NoAK1646 depicts
P.8.2 significant change of 5 % from zero to 1st time point, which needs clarification.
331. Name, address of Applicant / Importer M/s. Novartis Pharma (Pakistan) Limited,
15 West Wharf, Karachi, Pakistan
Address: Novartis Pharma (Pakistan) Limited,
15 West Wharf, Dockyard Road, Karachi,
Pakistan.
Address of Godown: C-21, SITE, Karachi.
Validity: 12-3-2023.
Renewal: NA
Name and address of marketing authorization Sandoz Pharmaceuticals AG, 6343 Risch,
holder (abroad) Schweiz.
Name, address of manufacturer(s) Sandoz GmbH, Biochemiestrasse 10, 6250
Kundl Austria
Name of exporting country Switzerland
Detail of certificates attached (CoPP, Free- Firm has submitted original & legalized CoPP
sale certificate, GMP certificate) certificate (No. 20003187) dated 29-06-2020
issued by Swissmedic for
Piperacillin/Tazobactam Sandoz 2.25g. The
CoPP confirms that this product is on the
market in exporting country as well as GMP
compliant status of manufacturer.
Details of letter of authorization / sole agency Firm has submitted original & legalized letter
agreement of Authorization/ Sole Agency Agreement.
This letter specifies that the manufacturer
appoints M/s Novartis Pharma (Pakistan) Ltd.,
Karachi. to register and market the product as
Sole Agent in Pakistan.
☒ Importer
giver)
☐ Export sale
purpose only
Dy. No. and date of submission Dy. No.31766 Dated: 10-08-2021
Details of fee submitted PKR 150,000/-slip No. 72231786648 10-08-
2021
The proposed proprietary name / brand name Piperacillin/Tazobactam Sandoz 2.25g Powder
for solution for Injection/Infusion
Pharmaceutical ingredient (API) per unit Piperacillin sodium..........2.12655g
(corresponding to 2000mg of Piperacillin)
Tazobactam sodium .......... 0.27366g
(Corresponding to 250mg of Tazobactam)
Pharmaceutical form of applied drug Powder for Solution for Injection/Infusion
Pharmacotherapeutic Group of (API) Antibacterial for systemic use
Reference to Finished product specifications Manufacturer’s Specs
Proposed Pack size 1 Vial powder for solution for
injection/infusion
Proposed unit price Proposed MRP per pack shall be furnished
later
The status in reference regulatory authorities Product has been approved in many stringent
regulatory authorities such as Belgium, France,
Spain, Switzerland, etc.
For generic drugs (me-too status) Tacip by M/S Macter International Limited
(Reg # 081175), Tazomax by M/S Mediceena
Pharma (Pvt.) Ltd. (Reg. # 059514), Mepnem
by M/S English Pharmaceuticals Industries
(Reg. # 064556), etc.
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO-QOS-
PD template. Firm has provided the
summarized information related to
Name, address of drug substance manufacturer Tazobactam
Shandong Anxin Pharmaceutical Co., Ltd.
Piperacillin:
Phase 1: North China Pharmaceutical Group
Semisyntech Co., Ltd and Zhuhai United
Laboratories Co.,Ltd.
Phase 2: Shandong Anxin Pharmaceutical Co.,
Ltd.
Stability Studies of Drug Substance Piperacillin:
(Conditions & duration of Stability studies) Firm has submitted stability study data of
Piperacillin under the 25 ± 2°C / 60%RH ± 5
% for Accelerated and 2°C to 8°C for
accelerated condition. The stability study for
Tazobactam Sodium:
The stability data of Tazobactam Sodium
under Long-term stability condition: 25°C ±
2°C 60 % ± 5 % rel. humidity and Accelerated
stability condition: 40°C ± 2°C 75 % ± 5 % rel.
humidity was provided. The Stability Study for
Pharmaceutical Equivalence and Comparative Firm has provided data of comparative Studies.
Dissolution Profile Comparative studies (physicochemical and
impurities profiles) have been performed with
originator products (i.e. Tazocin®,
Tazocilline® 2.25g and 4.5 g, respectively)
currently marketed in several European
countries (BE, GB, NO, FR)and the Sandoz
product. The results clearly indicate that all
European originator products tested and the
Sandoz product are essentially similar.
Container closure system of the drug product Injection Vial Glass Type III, injection vial
stopper, flip-off boarded cap
Stability study data of drug product, shelf life Firm has submitted stability study data for 24
and storage conditions months’ long-term stability conditions of
30°C/75% RH. Stability was also monitored at
accelerated storage condition at 40 °C/75% RH
for 6 months.
Evaluation by PEC:
# #
1. 1.1.5 • Provided GMP certificate of manufacturing site M/s Sandoz Austria, is
expired on 25-11-2021, provide valid and embassy attested GMP certificate
of manufacturer.
• Provided CoPP is issued by Switzerland Authorities(swismedic), country of
export is mentioned as Switzerland however authority Letter is issued by
Sandoz, Austria which needs clarification.
• Marketing Authorization holder abroad is not clarified in form 5-F
application.
2. 2.3. S.4 Under the heading of “Control of Drug Substance”, the manufacturer
mentioned is M/s Qilu Tianhe whereas per 2.3.S.2 the manufacturer of drug
substance i-e Piperacillin, /Tazobactam/Sterile Lyophilized mixture of
Piperacillin Tazobactam (8:1)1 is mentioned as M/s Shandong Axin Co. ltd.
Clarification is needed.
3. 3.2. S The Substance part of CTD dossier is submitted for Piperacillin and
tazobactam as separate powder substances whereas the actual substance to be
shipped to manufacturer M/s Sandoz Austria, is Piperacillin: Tazobactam
lyophilized bulk powder (8:1), therefore S Part with all its components of
Piperacillin: Tazobactam Lyophilized bulk powder in fixed ration 8:1 is
required.
4. 3.2.S.1.1 Active Substance Master File of Qilu Tianhe Pharmaceutical Co, Ltd is
provided for Piperacillin and Tazobactum which needs clarification.
5. 3.2.P.3.4 Control of Intermediate Piperacillin: Tazobactam Intermediate 8:1 is provided
by Qilu Tianhe, whereas manufacturing site is mentioned as M/s Shandong
Axin Pharmaceutical Co.Ltd.
6. 3.2.P.3.4 COA of Sodium bicarbonate is issued by Qilu Tianhe, which needs
clarification.
7. 3.2. COA for water for Injection is issued by Qilu Tianhe, which needs
P.3.4 clarification.
8. 3.2. Validation of Analytical procedure for Assay of Piperacillin and related
P.4.3 substance is conducted by M/s Qilu Pharmaceutical Cot Ltd and transferred to
Qilu Tianhe however no such transfer document is provided in this regard.
9. 3.2. Firm is intended to testing specification of Piperacillin monohydrate as per
S.4.5 Ph.Eur however the chromatographic conditions submitted for assay is varied
form Pharmacopoeial specifications.
10. 3.2. COA of Piperacillin Tazobactam Sterile bulk Powder is issued by Qilu Tianhe
P.3.4 which needs clarification.
11. 3.2.P.2.1 Justification for not conducting complete Pharmacopoeial tests as required to
.1 establish pharmaceutical equivalence. (Dissolving time, Particulate matter,
Clarity of reconstituted solution etc.)
12. 3.2. The stability data provided for accelerated study for batch NoAK1642 depicts
P.8.2 significant change of 5 %, from zero to 6 month, which needs clarification.
Decision: Registration Board has deferred for submission of the reply for above cited
332. Name, address of Applicant / Marketing M/S Welmark pharmaceuticals
Authorization Holder Industrial estate Hattar, Kpk Pakistan
Name, address of Manufacturing site. M/S Welmark pharmaceuticals
Plot No 122 Block-B phase-5 Industrial
estate Hattar Kpk Pakistan
☐ Importer
(contract giver)
GMP status of the firm The firm is granted GMP certificate based
on inspection conducted on 11-11-2021
and it is valid till 23-11-2023.
Evidence of approval of manufacturing The firm has provided Tablet general
facility section as confirmed from GMP
certificate.
☐ Export sale
Dy. No. and date of submission Dy No. 34234 dated 31-12-2021
Details of fee submitted PKR 30000/= dated
The proposed proprietary name / brand Empazin 25mg Tablet
name
Active Pharmaceutical ingredient (API) Empagliflozin………25mg
per unit
Pharmaceutical form of applied drug Chocolate brown color 8mm round
shaped both sides plain film coated
tablets.
Pharmacotherapeutic Group of (API) Anti diabatic
Reference to Finished product Innovator’s Specs
specifications
Status in reference regulatory authorities Empaa 25mg tablet by M/S Weather
Folds pharmaceuticals Hattar, Drap
Approved
For generic drugs (me-too status) Empaa 25mg tablet by M/S Weather
Folds pharmaceuticals Hattar, Drap
Approved
Name and address of API manufacturer Fuxin Long Rui Pharmaceutical Co Ltd
QOS-PD template. Firm has summarized
structure, general properties, solubility,
physical form, manufacturers, description
of manufacturing process and controls,
procedures and its validation, batch
substance.
The firm has summarized information of
drug product including its description,
composition, pharmaceutical
development, manufacture,
manufacturing process and process
control, process validation protocols,
control of excipients, control of drug
product, specifications, analytical
procedures, validation of analytical
specifications, reference standard or
materials, container closure system and
stability
Module-III Drug Substance: Firm has submitted detailed drug
procedures and its validation, batch
substance.
Stability Studies of Drug Substance 24 months real time stability data at 30°C
(Conditions & duration of Stability ± 2°C / 65% ± 5%RH of 03 batches.
studies) 06 month accelerated stability data 40°C
± 2°C / 75% ± 5%RH of 03 batches.
pharmaceutical development,
process control, process validation
protocols, control of excipients, control of
drug product, specifications, analytical
specifications, reference standard or
materials, container closure system and
stability.
Pharmaceutical Equivalence and Firm has submitted results of
Comparative Dissolution Profile pharmaceutical equivalence for all the
quality tests for their product against
Empaa 25mg Tablets (Batch No. 755,
Mfg date 09-2020) by Weather Folds
Pharmaceuticals Industrial Estate Hattar.
Firm has submitted results of CDP for
their product against Empaa 25mg Tablets
(Batch No. 755, Mfg date 09-2020).
Firm has tested CDP in three dissolutions
medium ie. (0.1N Hcl pH 1.2, Acetate
Buffer pH 4.5, Phosphate Buffer pH 6.8
and the results of f1, f2 factor are within
the acceptable limit.
Analytical method validation/verification Firm has submitted protocols and reports
of product of validation studies of analytical method.
Manufacturer of API Fuxin Long Rui Pharmaceutical Co Ltd
API Lot No. E-20181027-D02-E06-01
Description of Pack 14’s Tablets Empazin 25mg Tablets will be packed in

( container closure system) blister and Secondary Packing in Unit Carton.
Stability Storage Condition Real Time stability 30°C ± 2°C / 65% ± 5%RH
Accelerated stability 40°C ± 2°C / 75% ± 5%RH
Time Period Real Time 09 Months
Accelerated 06
Frequency Real Time 0,3,6,9 (Months)
Accelerated 0,3,6 (Months)
Batch No. EG01 EG02 EG03
No of Batches 03
1. Reference of previous The firm has referred to onsite inspection

approval of report of their product Sofosbuvir 400mg
applications with stability Tab, Registration Board decided to
study data of the firm (If any)
approve registration of Sofosbuvir 400mg
tab in minutes of 291 meeting by M/S
Welmark Pharmaceuticals Hattar.
The firm has referred to onsite inspection
report of their product Dapagliflozin
10mg Tab, Registration Board decided to
approve registration of Dapagliflozin
10mg tab in minutes of 307 meeting by
M/S Welmark Pharmaceuticals Hattar.
2. Approval of API/ DML/ GMP The firm has submitted GMP certificate
certificate of API Manufacturer issued by China food and
manufacturer issued by drug administration valid until 27-09-
concerned regulatory 2020
3. . Documents for the Firm has submitted copy of ADC attested
procurement of API with commercial invoice specifying purchase
approval from DRAP (in case of 410g.
of import) Copy of License to import drugs letter No
0031/2019-DRAPCPS/135 dated 09-01-
2019 is submitted.
4. Data of stability batches will Submitted
be supported by attested
respective documents like
chromatogram, Raw data
sheet, COA, summary data
sheet etc.
5. . Compliance record of HPLC Submitted
6. Record of Digital data logger Submitted
chambers(real time and
accelerated)
S.N Section Observation Justifications
o
1) 1.4.1 Applicant has checked for New Drug Revised submission of Generic
Product (NDP) Whereas the applied Drug Product is submitted.
molecule Empagliflozin has already
been registered, revised submission
as Generic Drug Product is required.
2) 2.3.S.1. Data/ information against this Submitted
3 section as mentioned in CTD
guidance document is missing,
which is required.
3) 2.3.S.3. Summary of studies performed to Submitted
1 identify the particle size distribution
of the API, including identification
of and data on the drug substance lot
used in stability studies is required as
the article size is mentioned in
Specification of Empagliflozin for
Innovator product Jardiance
(USFDA).
4) 2.3.S.4. COA of the Empagliflozin Batch No The manufacturer identification
4 E-20181027-D02-E06-01conducted of Empagliflozin by HPLC.
by API manufacturer does not reflect Test for Residual solvent is
Identification through IR method mentioned, Revised COA as per
more over test for residual solvent is submitted specification is
not conducted, which needs Submitted.
clarification / revised COA as per
submitted specification of API under
section 2.3.S.4.1.
5) 2.3.S.4. Justification of Specification of API The manufacturer identification
5 including exclusion of IR of Empagliflozin by HPLC.
identification, water content, residual Water content, residual solvents,
solvents, sulphated ash and particle sulphated ash and particle size is
size is required. submitted.
6) 2.3.P.3. The proposed commercial batch Submitted.
2 size(s) (e.g. number of dosage units)
mentioning list f all components of
the drug product to be used in the
manufacturing process and their
amounts on per batch basis
(including individual components of
mixtures prepared in house(e.g
coating) and overages, if any) is
missing which is required.
7) 2.3.P.3. The flow chart diagram of tableting Firm has submitted revised
3 process shows wet granulation as manufacturing process as direct
well as direct compression method. compression are following Direct
The descriptive part of section Compression.
2.3.P.3.3 does not mention wet
granulation method and literature
provided in dossier depicts mixing
and direct compression method.
However section 2.3.P.2.3 mentions
only wet granulation method,
Clarification and harmonization of
manufacturing method is required.
8) 2.3.P.3. The specifications/ limits mention for The weight variation limit is ±
4 weight variation is ± 5% whereas in 7.5%.
2.3.5.1 it is mentioned as ± 7.5% Documents submitted.
9) 2.3.P.4. For excipients of human or animal We are not using excipients of
5 origin, a certificate shall be provided, Human or animal origin.
confirming that the excipient(s) are
free from BSE and TSE. Which is
missing and is required?
10) 2.3.P.5. • Content uniformity is not Firm have performed Content

1 conducted which is required uniformity. (limit 85-115 %)
to be conducted as applied
API is 25mg and also the total
& content of API is 12% w/w of
proposed finished Drug Specification of Related
2.3.P.5. product/tablet? substance submitted.
4 • Specifications shall include
the degradation products and
related substances which are
missing.
11) 3.2.S.3 Discussion on the potential for Submitted.
isomerism and identification of
stereochemistry, studies performed
to identify potential polymorphic
forms and particle size distribution of
the Drug substance shall be
submitted, which are missing.
12) 3.2.S.7 Stability data of API for batch No • M/s WELMARK has submitted
20161017 under accelerated revised COA of API of Batch
condition is out of specifications at 6- No.20161017 at 6th month
month point (97.19). Moreover the stability mentioning assay as
stability data of the same batch under 99.19 under accelerated
real time conditions is also out of conditions. Firm has also
specifications at 12th, 18th and 24 submitted revised COA of API
months. (91.85%, 91.83%, and batch No.20161017 at 12th ,18th,
91.80% respectively which needs and 24 months (98.85
clarifications? %,99.39% and 98.95 %) at real
Provide API stability data for 3 time.
batches on accelerated and real time • API stability study data
study as conducted by API conducted by API manufacturer
manufacturer. is not submitted.
13) 3.2.P.2. Description of manufacturing Description of manufacturing
3 process mention wet granulation, process is direct compression.
whereas in section 3.2.P.3.3 depicts Documents submitted.
direct compression, clarification is
needed.
14) 3.2.P.3. The specification limit mention for The specification limit for weight
4 weight variation is ±5% whereas in variation is ±7.5.
3.2.P.5.1 it is mention as ±7.5% Documents submitted.
which is needed clarification.
15) 3.2.P.5. • Content uniformity test is not Content uniformity test is
1 conducted which is required to be conducted.
conducted as applied API is 25mg Documents submitted.
and also the total content of API is
12% w/w of proposed finished Drug
product/ tablet?
• Specification shall include Specification of Related
the degradation products and substances are included.
Documents submitted.
related substances which are
missing.

studies throughout proposed shelf life and on accelerated studies for six
months as per the commitment submitted in the registration application.
• Registration letter will be issued upon submission of stability studies data of
the drug substances as per the conditions of zone IV-A or otherwise provision
of degradation studies of the finished product for 6 months as per the decision
of Registration Board
☐ Importer
giver)
☐ Export sale
Details of fee submitted PKR 20,000/-: manual slip No1907516 dated
01-02-2021 & differential fee of PKR 10000/-
slip No.720791777477 dated 18-06-2021
Dexil 30mg Capsule
name
Pharmaceutical ingredient (API) per unit Dual Delayed Release Dexlansoprazole
(Enteric coated pellets) ………………… 30mg
Pharmaceutical form of applied drug Capsule Oral
Manufacturer’s Specs
specifications
MHRA Approved
authorities
For generic drugs (me-too status) Rasodex Capsule 30mg M/s Gets Pharma Reg.
No. 086976
Section Renewal granted on 12-03-2021
section approval Copy Submitted by the firm.
Name and address of API manufacturer. Vision Pharmaceutical (Pvt)Ltd Plot No 22-23
Industrial Triangle Khuta Road Islamabad
submitted.
Module III (Drug Substance) Dexlansoprazole DDR pellets are preparing
under manufacturer’s Specs. The firm as
substance
months
months
Batches: (DXL 01, DXL 02, DXL 03)
product.
Pharmaceutical equivalence and Pharmaceutical Equivalence established vis-
comparative dissolution profile à-vis the brand leader, Rasodex Capsule
30mg by M/s Gets Pharma by performing
quality tests. The results of all the tests of
both products fall within the specifications
and are comparable. The firm has performed
comparative analyses with innovator’s
product. The studies demonstrate
comparable results with the innovator
product.
Jaskan pharma has been performed against
the same brand that is Rasodex Capsule
30mg by Getz Pharma in Acid media (pH
range.
Analytical method validation/verification Firm has submitted reports of verification
of product studies of analytical method for the drug
substance.
Firm has also submitted reports of validation of
Manufacturer of API Vision Pharmaceutical (Pvt)Ltd Plot No 22-23 Industrial Triangle
Khuta Road Islamabad
API Lot No. DLP562
Description of Pack
Sealed In Alu-Alu Poly bag in Plastic Drum
Real Time: 0, 3, 6, (Months)
Batch No. DXL 01 DXL 02 DXL 03
No. of Batches 03
1. Reference of previous approval of Jaxikan 100mg/5ml Susp
applications with stability study data of the Arixkan 1gm IV Injection
firm (if any) Aquakan 5ml Injection
2. Approval of API/ DML/GMP certificate of Copy of DML certificate No. 000806 and
API manufacturer issued by concerned GMP Certificate No. F. 3-26/2019-
regulatory authority of country of origin. Addl.Dir(QA & LT-1) both issued by DRAP
Pakistan has been submitted
3. Documents for the procurement of API Local procurement
import).
5. Compliance Record of HPLC software Ezchrome Software with HPLC is being used.
21CFR & audit trail reports on product Data submitted.
testing
accelerated)
Sr.# Section# Observation
1. 3.2.S.4.1 The Drug substance specification of Dexlansoprazole pellets as per
innovator product does not mention optical rotation ,enantiomer ratio ,
and Chiral HPLC assay , which needs submission.
2. 3.2.S.4.3 • The submitted COA of Dexlansoprazole, conducted by M/s Vision
Pharma does not mention identification/Assay of Dexlansoprazole
through Chiral HPLC as Dexlansoprazole is R-isomer of Lansoprazole,
nor optical rotation test is conducted. As the innovator product Cap
Dexilent is USFDA approved, the review of innovator product
specifically mention that drug substance should be assay by such
method which ensures its enantiomeric form.
• Justification of existing analytical method by HPLC and UV
spectroscopy for conducting identification, assay and dissolution assay
of Dexlansoprazole is required.
3. 3.2.S.5 The submitted COA of source of API working standard,
(Dexlansoprazole) M/s Everest Organics Limited, India, has mentioned
Identification /Assay through Chiral HPLC, however same is not
depicted through COA of API by local pellets manufacturer. i-e M/s
Vision pharmaceuticals, Islamabad.
Dexlansoprazole is a racemic enantiomer of Lansoprazole, Optical
rotation test is performed by API manufacturer, however as per COA
of Pellets , same is not performed by Pellet manufacturer , as well as
finished product manufacturer which needs clarification
4. 3.2.P.2.2.1 The comparative dissolution study and F2 calculation is not conducted
at PH. 5.5 as required to establish similarity of initial release at ph 5.5.
5. 3.2.P.5 • Complete drug product specification(s) including tests, acceptance
criteria and reference to analytical procedure along with impurities
testing is required.
• Complete analytical method validation study 0f assay on HPLC
including specificity, Method precision, Accuracy, linearity,
reproducibility, robustness and ruggedness is needed.
6. 3.2.P.8 • Frim has used UV spectroscopy method instead of HPLC method for
conducting Assay for stability study data.which needs justification.
• Invoice of procurement of pellets from source is missing which is also
required.
☐ Importer
giver)
☐ Export sale
Details of fee submitted PKR 20,000/-: manual slip No1907515 dated
01-02-2021 & differential fee of PKR 10000/-
slip No.30406862 dated 18-06-2021
Dexil 60mg Capsule
name
Strength / concentration of drug of Each Capsule Contains:
Active Pharmaceutical ingredient (API) DDR Dexlansoprazole (Enteric coated pellets)
per unit …. 60mg
Pharmaceutical form of applied drug Capsule Oral
Manufacturer’s Specs
specifications
MHRA Approved
authorities
For generic drugs (me-too status) Rasodex Capsule 60mg M/s Gets Pharma Reg.
No. 086977
Section Renewal granted on 12-03-2021
section approval Copy Submitted by the firm.
Name and address of API manufacturer. Vision Pharmaceutical (Pvt)Ltd Plot No 22-23
Industrial Triangle Khuta Road Islamabad
submitted.
Module III (Drug Substance) Dexlansoprazole DDR pellets are prepare
under manufacturer’s Specs The firm as
substance
months
months
Batches: (DXT 01, DXT 02, DXT 03)
product.
Pharmaceutical equivalence and Pharmaceutical Equivalence established vis-
comparative dissolution profile à-vis the brand leader, Rasodex Capsule
60mg by M/s Gets Pharma by performing
quality tests the results of all the tests of both
products fall within the specifications and
are comparable. The firm has performed
comparative analyses with innovator’s
product. The studies demonstrate
comparable results with the innovator
product.
Jaskan pharma has been performed against
the same brand that is Rasodex Capsule
60mg by Getz Pharma in Acid media (pH
range.
Analytical method validation/verification Firm has submitted reports of verification
of product studies of analytical method for the drug
substance.
Manufacturer of API Vision Pharmaceutical (Pvt)Ltd Plot No 22-23 Industrial Triangle
Khuta Road Islamabad
API Lot No. DLP562
Description of Pack
Sealed In Alu-Alu Poly bag in Plastic Drum
Real Time: 0, 3, 6, (Months)
Batch No. DXT 01 DXT 02 DXT 03
No. of Batches 03
7. Reference of previous approval of Jaxikan 100mg/5ml Susp
applications with stability study data of the Arixkan 1gm IV Injection
firm (if any) Aquakan 5ml Injection
8. Approval of API/ DML/GMP certificate Copy of DML certificate No. 000806 and
of API manufacturer issued by concerned GMP Certificate No. F. 3-26/2019-
regulatory authority of country of origin. Addl.Dir(QA & LT-1) both issued by DRAP
Pakistan has been submitted
9. Documents for the procurement of API Local procurement
import).

11. Compliance Record of HPLC software Ezchrome Software with HPLC is being used.
21CFR & audit trail reports on product Data submitted.
testing
accelerated)
Sr.# Section# Observation
1. 3.2.S.4.1 The Drug substance specification of Dexlansoprazole pellets as per
innovator product does not mention optical rotation ,enantiomer ratio ,
and Chiral HPLC assay , which needs submission.
2. 3.2.S.4.3 • The submitted COA of Dexlansoprazole, conducted by M/s Vision
Pharma does not mention identification/Assay of Dexlansoprazole
through Chiral HPLC as Dexlansoprazole is R-isomer of Lansoprazole,
nor optical rotation test is conducted. As the innovator product Cap
Dexilent is USFDA approved, the review of innovator product
specifically mention that drug substance should be assay by such
method which ensures its enantiomeric form.
• Justification of existing analytical method by HPLC and UV
spectroscopy for conducting identification, assay and dissolution assay
of Dexlansoprazole is required.
3. 3.2.S.5 The submitted COA of source of API working standard,
(Dexlansoprazole) M/s Everest Organics Limited, India, has mentioned
Identification /Assay through Chiral HPLC, however same is not
depicted through COA of API by local pellets manufacturer. i-e M/s
Vision pharmaceuticals, Islamabad.
Dexlansoprazole is a racemic enantiomer of Lansoprazole, Optical
rotation test is performed by API manufacturer, however as per COA
of Pellets , same is not performed by Pellet manufacturer , as well as
finished product manufacturer which needs clarification
4. 3.2.P.2.2.1 The comparative dissolution study and F2 calculation is not conducted
at PH. 5.5 as required to establish similarity of initial release at ph 5.5.
5. 3.2.P.5 • Complete drug product specification(s) including tests, acceptance
criteria and reference to analytical procedure along with impurities
testing is required.
• Complete analytical method validation study 0f assay on HPLC
including specificity, Method precision, Accuracy, linearity,
reproducibility, robustness and ruggedness is needed.
6. 3.2.P.8 • Frim has used UV spectroscopy method instead of HPLC method for
conducting Assay for stability study data.which needs justification.
• Invoice of procurement of pellets from source is missing which is also
required.
C: Human ( Local ) (Deferred) Form- 5 F (CTD)
335. Name, address of Applicant / Marketing M/s May & Baker Pharmaceuticals (Pvt.)
Authorization Holder Ltd. 45 Km, Thokar Multan road, Lahore
Name, address of Manufacturing site. M/s May & Baker Pharmaceuticals (Pvt.) Ltd.
45 Km, Thokar Multan road, Lahore
☐ Importer
giver)
☐ Export sale
Evidence of Manufacturing facility Issuance of DML vide letter no. F.1-10/2019-Lic.
Dated 29-04-2022 for sections of Injectable
ampoule (General), Capsule section (general),
Dry powder suspension section (general), Dry
powder vial section (general)
Dy. No. and date of submission Dy. No 26359 dated 19-09-2022
The proposed proprietary name / brand name WFI 5 ml Injection
Strength / concentration of drug of Active Each 5 ml ampoule contains:
Pharmaceutical ingredient (API) per unit Water for Injection …….5 ml
Pharmaceutical form of applied drug Liquid injection
Pharmacotherapeutic Group of (API) Solvent/ Diluent
Reference to Finished product specifications USP/BP
Proposed Pack size 1ml(1x1,s) (10’s,14’s,100’s)
The status in reference regulatory authorities Approved by USFDA, MHRA, Sterile water
for Injection
For generic drugs (me-too status) WFI 5ml by Global Pharma
GMP status of the Finished product Issuance of DML vide letter no. F.1-10/2019-Lic.
manufacturer Dated 29-04-2022 for sections of Injectable
Name and address of API manufacturer. N/A
Module-II (Quality Overall Summary) Firm has submitted summarized information

properties, solubility, physical form,
process and controls, specifications, batch
analysis and justification of specification, and
stability
studies of drug product is submitted.
Module III (Drug Substance) Official monograph of sterile Water for injection
is present in BP and USP. The firm as submitted
process and controls, tests for, specifications,
analytical procedures,
batch analysis and justification of specification.
Stability studies N/A
controls, specifications, analytical and batch
drug product
Pharmaceutical equivalence and comparative Water for Injection Mfg By : Amros

dissolution profile Phamrceuticals .
Analytical method validation/verification of N/A
product
Manufacturer of API N/A
API Lot No. N/A
Description of Pack
BP type 1 ,Glass ampoules
No. of Batches 03
1. Reference of previous approval of applications Not submitted
2. Approval of API/ DML/GMP certificate of N/A
3. Documents for the procurement of API with Not submitted.
5. Compliance Record of HPLC software 21CFR N/A
& audit trail reports on product testing.
1. Firm has mentioned drug substance specification with acceptance criteria mentioning white or
off-white, FTIR absorption, impurities and assay that does not corresponds to Claimed B.P &
USP specifications., clarify.
2. Declared Pharmacopoeia specification in 1.5.6 are mentioned USP specification where in COA
of Bulk water for injection mention BP. Clarify
3. Test for Total Organic Carbon is not mentioned in COA, same is required.
4. Container Closure mentioned as inner Packaging material: LDPE for medical packing,
justification for this container closure is required.
5. The description of primary container is required along with justification.
6. Specification of bulk water testing does not mention Total Organic Carbon (TOC) and microbial
testing.
7. Firm has mentioned sieving process through mechanical sifter under description of
manufacturing process, which needs clarification and resubmission.
8. Under filling process, firm has mentioned “Dark green color vol. yellow color body injection
containing off whit colour “Justification is required
9. The finished product specification is mentioned as BP whereas under 1.5.6 it is mentioned as
USP, Clarification of applied specification of product is required
10. Complete testing specification of finished product is required including test for sub visible
particle.
11. The declared B.P monograph is “sterilized water for injection” for finished drug product,
whereas firm has adopted nomenclature 4for finish drug product as ‘water for injection’,
therefore correction throughout module 2 & 3, (P part) is required
12. Firm has mentioned Inactive martial as Shell No.03, Which needs clarification.
13. Required complete testing results conducted for stability studies data including PH/Alkalinity
testing, Chloride, Ammonium, Calcium, Nitrate, sulphate, sub visible particles. TOC,
conductivity test and, residue on evaporation for both real time and accelerated stability data for
6 months of trial batches.
Previous Decision of 320th meeting: The Board deferred the case for the above mentioned points.
Reply of firm vide dairy No 3002 dated 24-10-2022
SR Observation Response of firm
#
1 Firm has mentioned drug substance It is typo error
specification with acceptance criteria
mentioning white or off-white, FTIR
absorption, impurities and assay that
does not corresponds to Claimed B.P &
USP specifications., clarify
2 Declared Pharmacopoeia specification in It’s a typo error B.P monograph has been
1.5.6 are mentioned USP specification adopted by the firm for the analysis of water
where in COA of Bulk water for injection and its specifications.
mention BP. Clarify
3 Test for Total Organic Carbon is not Revised COA is submitted by firm
mentioned in COA, same is required. .mentioning TOC test.
4 Container Closure mentioned as inner It’s a typo error whereas the WFI is packed in
Packaging material: LDPE for medical 10 ml or 5 ml
packing, justification for this container
closure is required
5 The description of primary container is It is packed in glass ampoule of 5 ml or 10 ml
required along with justification .
6 Specification of bulk water testing does Firm has submitted revised COA mentioning
not mention Total Organic Carbon TOC and microbial testing specifications.
(TOC) and microbial testing
7 Firm has mentioned sieving process Revised manufacturing process is submitted
through mechanical sifter under by firm.
description of manufacturing process,
which needs clarification and
resubmission.
8. Under filling process, firm has It’s a typo error .The firm has submitted
mentioned “Dark green color vol. yellow revised manufacturing process
color body injection containing off whit
colour “Justification is required.
9 The finished product specification is It’s a typo error .The firm has adopted BP
mentioned as BP whereas under 1.5.6 it monograph for its testing specifications.
is mentioned as USP, Clarification of
applied specification of product is
required
10 Complete testing specification of Revised testing specification of finished
finished product is required including test product is submitted mentioning sub visible
for sub visible particle particle test.
11 Firm has mentioned Inactive martial as It’s a typo error.
Shell No.03, Which needs clarification.
12 Required complete testing results Firm has submitted revised stability study
conducted for stability studies data data for 6 months a per adopted BP
including PH/Alkalinity testing, specification for real time and accelerated
Chloride, Ammonium, Calcium, Nitrate, data.
sulphate, sub visible particles. TOC,
conductivity test and, residue on
evaporation for both real time and
accelerated stability data for 6 months of
trial batches
Decision: Approved with B.P specifications.
of applicable fee for pre-registration variation ,i-e 30000/= as per notification No.F.7-
11/2012-B&A/DRAP dated 07- 05-2021.
336. Name, address of Applicant / Marketing M/s May & Baker Pharmaceuticals (Pvt.)
Authorization Holder Ltd. 45 Km, Thokar Multan road, Lahore
Name, address of Manufacturing site. M/s May & Baker Pharmaceuticals (Pvt.) Ltd.
45 Km, Thokar Multan road, Lahore
☐ Importer
giver)
☐ Export sale
Evidence of Manufacturing facility Issuance of DML vide letter no. F.1-10/2019-Lic.
Dated 29-04-2022 for sections of Injectable
The proposed proprietary name / brand name WFI 10 ml Injection
Strength / concentration of drug of Active Each 10 ml ampoule contains:
Pharmaceutical ingredient (API) per unit Water for Injection …….10 ml
Pharmaceutical form of applied drug Liquid injection
Pharmacotherapeutic Group of (API) Solvent/ Diluent
Reference to Finished product specifications USP/BP
Proposed Pack size 1ml(1x1,s) (10’s,14’s,100’s)
The status in reference regulatory authorities Approved by USFDA, MHRA, Sterile water
for Injection
For generic drugs (me-too status) Water for Injection of M/s Visison Pharma
(Reg.# 032340)
GMP status of the Finished product Issuance of DML vide letter no. F.1-10/2019-Lic.
manufacturer Dated 29-04-2022 for sections of Injectable
Name and address of API manufacturer. N/A
Module-II (Quality Overall Summary) Firm has submitted QOS information related to
solubility, physical form, manufacturers,
controls, specifications, batch analysis and
justification of specification, and stability.studies
of drug product is submitted.
Module III (Drug Substance) Official monograph of sterile Water for injection
is present in BP and USP. The firm as submitted
process and controls, tests for, specifications,
analytical procedures,
batch analysis and justification of specification.
Stability studies N/A
controls, specifications, analytical and batch
drug product
Pharmaceutical equivalence and comparative Water for Injection Mfg. By : Amros
dissolution profile Pharmaceuticals .
Analytical method validation/verification of N/A
product
Manufacturer of API N/A
API Lot No. N/A
Description of Pack
BP type 1 ,Glass ampoules
No. of Batches 03
7. Reference of previous approval of applications Not submitted
8. Approval of API/ DML/GMP certificate of N/A
9. Documents for the procurement of API with Not submitted.
11. Compliance Record of HPLC software 21CFR N/A
& audit trail reports on product testing.
1. Firm has mentioned drug substance specification with acceptance criteria mentioning white or
off-white, FTIR absorption, impurities and assay that does not corresponds to Claimed B.P &
USP specifications., clarify.
2. Declared Pharmacopoeia specification in 1.5.6 are mentioned USP specification where in COA
of Bulk water for injection mention BP. Clarify
3. Test for Total Organic Carbon is not mentioned in COA, same is required.
4. Container Closure mentioned as inner Packaging material: LDPE for medical packing,
justification for this container closure is required.
5. The description of primary container is required along with justification.
6. Specification of bulk water testing does not mention Total Organic Carbon (TOC) and microbial
testing.
7. The finished product specification is mentioned as BP whereas under 1.5.6 it is mentioned as
USP, Clarification of applied specification of product is required
8. Complete testing specification of finished product is required including test for sub visible
particle.
9. The declared B.P monograph is “sterilized water for injection” for finished drug product,
whereas firm has adopted nomenclature for finish drug product as ‘water for injection’ ,
therefore correction throughout module 2 & 3, (P part ) is required
10. Required complete testing results conducted for stability studies data including PH/Alkalinity
testing, Chloride, Ammonium, Calcium, Nitrate, sulphate, sub visible particles. TOC,
conductivity test and, residue on evaporation for both real time and accelerated stability data for
6 months of trial batches.
Previous Decision of 320th meeting: The Board deferred the case for the above mentioned points.
Reply of firm vide dairy No 3002 dated 24-10-2022
SR Observation Response of firm
#
1 Firm has mentioned drug substance It is typo error
specification with acceptance criteria
mentioning white or off-white, FTIR
absorption, impurities and assay that
does not corresponds to Claimed B.P &
USP specifications., clarify
2 Declared Pharmacopoeia specification in It’s a typo error B.P monograph has been
1.5.6 are mentioned USP specification adopted by the firm for the analysis of water
where in COA of Bulk water for injection and its specifications.
mention BP. Clarify
3 Test for Total Organic Carbon is not Revised COA is submitted by firm
mentioned in COA, same is required. .mentioning TOC test.
4 Container Closure mentioned as inner It’s a typo error whereas the WFI is packed in
Packaging material: LDPE for medical 10 ml or 5 ml
packing, justification for this container
closure is required
5 The description of primary container is It is packed in glass ampoule of 5 ml or 10 ml
required along with justification .
6 Specification of bulk water testing does Firm has submitted revised COA mentioning
not mention Total Organic Carbon TOC and microbial testing specifications.
(TOC) and microbial testing
7 Firm has mentioned sieving process Revised manufacturing process is submitted
through mechanical sifter under by firm.
description of manufacturing process,
which needs clarification and
resubmission.
8. Under filling process, firm has It’s a typo error .The firm has submitted
mentioned “Dark green color vol. yellow revised manufacturing process
color body injection containing off whit
colour “Justification is required.
9 The finished product specification is It’s a typo error .The firm has adopted BP
mentioned as BP whereas under 1.5.6 it monograph for its testing specifications.
is mentioned as USP, Clarification of
applied specification of product is
required
10 Complete testing specification of Revised testing specification of finished
finished product is required including test product is submitted mentioning sub visible
for sub visible particle particle test.
11 Firm has mentioned Inactive martial as It’s a typo error.
Shell No.03, Which needs clarification.
12 Required complete testing results Firm has submitted revised stability study
conducted for stability studies data data for 6 months a per adopted BP
including PH/Alkalinity testing, specification for real time and accelerated
Chloride, Ammonium, Calcium, Nitrate, data.
sulphate, sub visible particles. TOC,
conductivity test and, residue on
evaporation for both real time and
accelerated stability data for 6 months of
trial batches
Decision: Approved with B.P specifications.

of applicable fee for pre-registration variation ,i-e 30000/= as per notification No.F.7-
11/2012-B&A/DRAP dated 07- 05-2021.
D- Human (Import ) (Deferred) Form-5-A

337. Name and address of Applicant Name: Revive Healthcare
Address: 503, 5th floor, Eden Hieghts,6 Main
Gulberg, Jail road, Lahore
Detail of Drug Sale License Name: Revive Healthcare
Go-down address: N/A
License No: 05-352-0065-031159D
Validity: 21st May 2020
Status: Distributor license in Form No. 11
Name and address of manufacturer United Biotech (p) Limited, Bagbania, Baddi-
Nalagarh Road, District Solan(HP)-174
101,India
Name and address of marketing United Biotech (p) Limited, Bagbania, Baddi-
authorization holder Nalagarh Road, District Solan(HP)-India
Type of Form Form-5A
Diary No. & Date of R& I Dy. No. 13066 dated 06-03-2019
Fee including differential fee Rs.100000/- dated 06-03-2019 Challan
No.1902056 dated: 06.03.2019
Brand Name +Dosage Form + Strength UNIFOLIN 100 Injection
Composition Each Vail Contains;
Leucovorin Calcium ………………….100
mg/10 ml
Pharmacological Group Detoxifying agent for antineoplastic treatment
Shelf life 24 Month ( 2-8 C)
Demanded Price As per DPC
Pack size 1’s
International availability Not traceable
Me-too status Not varified
Stability studies Firm has submitted real-time stability data
sheets conducted at 50C ± 3ºC three industrial
batches for 24 months (Shelf life 24 months) and
accelerated stability data sheets conducted at
250C ± 2 ºC and 65%RH ± 5%RH of three
industrial batches for six months.
Mfg. Date: 06-2013
Detail of certificates attached legalized GMP certificate:
Certificate No: HFW-H(Drugs)427/05
Certifying Authority: State Drugs Controller,
Controlling Cum Licensing Authority Nagar
panchayat Bhawan, Sai road baddl dist,Solan.
Scan copy of legalized DML.

Serial: Not Provided
Original legalized CoPP (Embassy attested).

Certificate No: HFW-H9(DRUGS) 461/05/241
18-09-2019
Certificate date:22-01-2018
Certifying Authority: Office of State Drugs
Controller, Licensing Authority Cum
Controlling Authority Health & family welfare
Department, Himachal Pradesh, India
legalized Free sale Certificate.
Certificate No: HFW-H(DRUGS)/427/09
Licensing Authority Cum Controlling
Authority, Baddi, District -Solan (HP)
Issuing Date: 21-11-2017
Agency Agreement (Copy)
Between Revive Healthcare, 503, 5th floor,
Eden Hieghts,6 Main Gulberg, Jail road,
Lahore. (Distributor) and United BioTech (P)
Limited, E-142, aket, New Dehli 110017. India.
Date of Agreement: 01-03-2012
Validity: Complete agreement mentioning
validity is not provided.
Remark of the Evaluator XVI 1. DML (copy) is not provided.
2. Firm has conducted Accelerated stability
study for 3 batch at 65 % RH, whereas
recommended Relative Humidity is 60 % for
accelerated stability study.
3. Original legalized (Embassy attested) CoPP
is missing. Copy is provided which is also
expired.
4. Legalized copy of GMP certificate is
missing, Photocopy is provided valid up to
18-09-2019.
5. Complete Agency /Exclusive distribution
agreement mentioning validity is not
provided.
6. DSL expired.
7. Evidence of approval of applied formulation
in reference regulatory authorities/agencies
which were adopted by the Registration
Board in its 275th meeting.
8. Form 5-A mentioning
“UNIFOLIN(Leucovorin) Injection 50 mg,
where in attached annexures the composition
as label claim is Each Vial Contains
Leucovorin calcium Injection 100 mg/10 ml.
9. evidence of applied formulation/drug
already approved by DRAP (generic / me-
too status) along with registration number,
10. Product label does not have” URDU
“Inscription as required under drug labeling
and packaging rule 1978.
st
Decision of 321 meeting: Deferred for following shortcomings:
1. DSL (copy) is not provided.
2. Firm has conducted Accelerated stability study for 3 batch at 65 % RH, whereas
recommended Relative Humidity is 60 % for accelerated stability study.
3. Original legalized (Embassy attested) CoPP is missing. Copy is provided which is also
expired.
4. Legalized copy of GMP certificate is missing, Photocopy is provided valid up to 18-09-
2019.
5. Complete Agency /Exclusive distribution agreement mentioning validity is not provided.
6. DSL expired.
7. Evidence of approval of applied formulation in reference regulatory authorities/agencies
which were adopted by the Registration Board in its 275th meeting.
8. Form 5-A mentioning “UNIFOLIN(Leucovorin) Injection 50 mg, where in attached
annexures the composition as label claim is Each Vial Contains Leucovorin calcium
Injection 100 mg/10 ml.
9. evidence of applied formulation/drug already approved by DRAP (generic / me-too status)
along with registration number, brand name and name of firm.
10.Product label does not have” URDU “Inscription as required under drug labeling and
packaging rule 1978.
Reply/response of Firm vide dairy No.23549 dated 19-08-2022
Sr# Shortcomings Reply
1 DML (copy) is not provided DML copy attached
Firm has submitted Accelerated We have already provided Accelerated
stability study data for 3 batches at stability at Humidity of 60%,
2 65 % RH, whereas recommended Nevertheless we have again attached
Relative Humidity is 60 % for stability study data for your reference of
60% RH.
accelerated stability study which
Original legalized (Embassy Original legalized Valid (Embassy
3 attested) CoPP is missing. Copy is attested) CoPP is attached
provided which is also expired
Legalized copy of GMP certificate Legalized Valid copy of GMP attached
4 is missing, Photocopy is provided
valid up to 18-09-2019.
Complete Agency /Exclusive Valid Complete Agency /Exclusive
5 distribution agreement mentioning distribution agreement attached
6 DSL expired Valid DSL copy attached
Evidence of approval of applied Evidence of applied product in RRA
formulation in reference regulatory attached
authorities/agencies which were Product: Leucovorin Calcium Injection
7
adopted by the Registration Board 100mg/10ml
in its 275th meeting Company: Bedford Laboratories
(USFDA Approved)
Form 5-A mentioning It was typographic mistake 50mg,
UNIFOLIN(Leucovorin) Injection Updated form 5-A attached with
50 mg, where in attached annexures corrected amount of API in vial (100
8 the composition as label claim is mg/10ml) and
‘’Each Vial Contains Leucovorin Label Claim: Each mL contains:
calcium Injection 100 mg/10 ml’’. Leucovorin calcium eq. to Leucovorin
…….10 mg
Evidence of applied Evidence of generic-me too approval
formulation/drug already approved by DRAP:
9 by DRAP (generic / me-too status) CALFONATE INJECTION 100MG by
along with registration number, M/s GHAZALI
brand name and name of firm. BROTHERS, Reg. No. 70936
Proposed Product label does not Updated artworks with URDU
10 have" URDU "Inscription as "Inscription" attached
required under drug labeling and
packaging rule 1978
• Firm has provided RRA reference of Injection Lecuvorin Calcium 100mg/10
ml manufactured by M/s Bedford laboratories, (USFDA approved), The said
RRA reference is not verifiable.
• Firm has submitted scan copy of COPP with original embassy attestation
• Applied finished product Injection Leucovorin calcium 100 mg/10ml is approved
in MHRA under the generic drug as Injection Calcium Folinate (as Folinic Acid)
100 mg/ 10 ml.
Decision: Approved with USP specification as under.
“Each 10 ml Vial contain;
Leucovorin Calcium eq to Leucovorin……………100 mg ( 10mg/ml)”.
• Registration Board further decided that registration letter shall be issued
after submission of applicable full fee for pre-registration variation ,i-e
100000/= as per notification No.F.7-11/2012-B&A/DRAP dated 07- 05-2021
for correction of label claim.
338. Name and address of Applicant Name: Revive Healthcare
Detail of Drug Sale License Name: Revive Healthcare
Go-down address: N/A
License No: 05-352-0065-031159D
Validity: 21st May 2020
Status: Distributor license in Form No. 11
Name and address of manufacturer United Biotech (p) Limited, Bagbania, Baddi-
Nalagarh Road, District Solan(HP)-174
101,India
Name and address of marketing United Biotech (p) Limited , Bagbania, Baddi-
authorization holder Nalagarh Road, District Solan(HP)-India
Type of Form Form-5A
Diary No. & Date of R& I Dy. No. 13065 dated 06-03-2019
Fee including differential fee Rs.100000/- dated 06-03-2019 Challan
No.1902057 dated: 06.03.2019
Brand Name +Dosage Form + Strength UNIPLATIN Injection 50 mg
Composition Each Vail Contains;
Cisplatin …………………….50 mg/50ml
Finished Product Specification BP
Pharmacological Group Other antineoplastic agents (Platinum
compounds)
Shelf life 24 Month
Demanded Price As per DPC
Pack size 1’s * 50 ml
International availability Cisplatin 1 mg/ml Concentrate for solution for
infusion (50ml vial) by M/s EBEWE Pharma
(MHRA approved)
Me-too status UNISTIN 50mg vial by M/s Al- Habib Pharma
(Reg#020661)
Stability studies Firm has submitted long term stability data
sheets conducted at 25 ºC ± 2ºC and 60% RH for
three industrial batches for 24 months (Shelf life
24 months) and accelerated stability data sheets
conducted at 400C ± 2 ºC and 75%RH ± 5%RH
of three industrial batches for six months.
Mfg. Date: 07-2015
Detail of certificates attached legalized GMP certificate:
Certificate No: HFW-H(Drugs)427/05
Controlling Cum Licensing Authority Nagar
panchayat Bhawan, Sai road baddl dist, Solan.
Scan copy of legalized DML.

Serial: Not Provided
Original legalized CoPP (Embassy attested).

Certificate No: HFW-H(DRUGS) 461/05/231
Certificate date:22-01-2018
Certifying Authority: Office of State Drugs
Controller, Licensing Authority Cum
Controlling Authority Health & family welfare
Department, Himachal Pradesh, India.
legalized Free sale Certificate.
Certificate No: HFW-H(DRUGS)/427/09
Licensing Authority Cum Controlling
Authority, Baddi, District -Solan (HP)
Issuing Date: 21-11-2017
Agency Agreement (Copy)
Between Revive Healthcare, 503, 5th floor,
Eden Hieghts,6 Main Gulberg, Jail road,
Lahore. (Distributor) and United BioTech (P)
Limited, E-142, aket, New Dehli 110017. India.
Date of Agreement: 01-03-2012
Validity: Complete agreement mentioning
XVI
Remark of the Evaluator 1. DML (copy) is not provided.
2. The temperature and humidity
conditions (25 ºC ± 2ºC and 60% RH) of
the submitted stability study data for
long term stability of 3 batches is not
according to zone IV a, which needs
clarification.
3. Original legalized (Embassy attested)
CoPP is missing. Copy is provided
which is also expired.
4. Legalized copy of GMP certificate is
missing, Photocopy is provided valid up
to 18-09-2019.
5. Complete Agency /Exclusive
distribution agreement mentioning
6. DSL expired.
7. Label claim in firm 5A mentions 50
mg/5ml, where in attached annexure
master formulation is mentioned as 50
mg/20 ml, which needs clarification.
Decision of 321st meeting: Deferred for following shortcomings:
1. DSL (copy) is not provided.
2. The temperature and humidity conditions (25 ºC ± 2ºC and 60% RH) of the submitted
stability study data for long term stability of 3 batches is not according to zone IV a,
3. Original legalized (Embassy attested) CoPP is missing. Copy is provided which is also
expired.
4. Legalized copy of GMP certificate is missing, Photocopy is provided valid up to 18-09-
2019.
5. Complete Agency /Exclusive distribution agreement mentioning validity is not
provided.
6. DSL expired.
7. Label claim in firm 5A mentions 50 mg/5ml, where in attached annexure master
formulation is mentioned as 50 mg/20 ml, which needs clarification.
Reply of firm vide dairy No.23548 dated 19-08-2022
Sr# Shortcomings Reply
1 DML (copy) is not provided DML copy attached
The temperature and humidity Product manufacturer (United Biotech
conditions (25 oC ±2oC and 60% India), performed stability studies
RH) of the submitted stability study both on Zone IVa & Zone IVb.
2
data for long term stability of 3 Zone IVa stability study data (30 oC
batches is not according to zone ±2oC and 65% ± 5% RH) is attached
IVa, which needs clarification for your reference
Original legalized (Embassy Original legalized Valid (Embassy
3 attested) CoPP is missing. Copy is attested) CoPP is attached
provided which is also expired
Legalized copy of GMP certificate Legalized Valid copy of GMP
4 is missing, Photocopy is provided attached
valid up to 18-09-2019.
Complete Agency /Exclusive Valid Complete Agency /Exclusive
5 distribution agreement mentioning distribution agreement attached
6 DSL expired Valid DSL copy attached
Label claim in firm 5A mentions 50 It was typographic mistake in Form 5-
mg/5ml, where in attached annexure A & Master formula.
7 master formulation is mentioned as Updated form 5-A & Master formula
50 mg/20 ml, which needs attached with corrected label claim of
clarification 50 mg/50ml (as per COPP)
Proposed Product label does not Updated artworks with URDU
8 have" URDU "Inscription as "Inscription" attached
required under drug labeling and
packaging rule 1978
Firm has submitted scan copy of COPP with original embassy attestation
Decision: Approved with B.P specifications with following label claim,
“Each 5ml Vial Contains:
Cisplatin …………………50 mg (10mg/ml)”
Registration Board further decided that registration letter shall be issued after
submission of applicable full fee for pre-registration variation, i-e 100000/= as per
notification No.F.7-11/2012-B&A/DRAP dated 07- 05-2021 for correction of master
formulation as 50mg/5 ml .
E :- Human (Local ) (Deffered) Form-5

339. Name and address of manufacturer/ Genix Pharma (Pvt) Ltd.44,45-B, Korangi
Applicant Chowk Road, Karachi.
Brand Name + Dosage Form + Strength TEGLIP Tablet 20 mg
Teneligliptin Hydrobromide Hydrate eq. to
Teneligliptin…………………………20 mg
Diary No. Date of R & I & fee Dy. No 11977 dated 06-03-2019; Rs.50,000/-
dated 06-03-2019.
Type of Form Form – 5D
Finished product Specification Innovator Specification
Pack size & Demanded Price 7’s,14’s,28’s,10’s,20’s &30’s, As per SRO.
Approval status of product in Reference Tablet Tenelia, Mitsubishi Tanabe Pharma,
Regulatory Authorities PMDA Japan.
Me-too status Not provided.
GMP status GMP inspection was conducted on 12-02-2020
and concluded as, “Based on the area inspected,
the people met and the document reviewed and
considering the findings of the inspection
including the observation listed above M/s
Genix Pharma Private Limited Located at Plot
No.44-45-B Korangi, Creek Road Karachi,
Pakistan was considered to be operating at a
good level of compliance with cGMP guideline
as of today.”
Remarks of the Evaluator • Evidence of applied • Form submitted
formulation/drug reply and submitted
already approved by me-too reference as
DRAP (generic / me- tablet Tenliptin,Reg
too status) along with # 105239,Indus
registration number, Pharma , the same is
brand name and name not verifiable from
of firm. available record.
• Stability study data as • Firm has submitted
per guidelines scan copy of Form-5
provided in 293rd annexure on
meeting of prescribed format.
Registration Board is
required.
• Form-5 Annexure as
per prescribed format
of Drug (L, R&A)
rules 1976.
Previous decision of 321st meeting: Deferred for following

• Evidence of applied formulation/drug already approved by DRAP (generic / me-too
status) along with registration number, brand name and name of firm.
• Stability study data as per guidelines provided in 293rd meeting of Registration
Board is required.
Reply of the firm : Firm has attached mee too reference of Tablet Tenliptin ,Reg No 105239
of Indus Pharma khi.
Remarks of evaluator : Stability study data as per guidelines provided in 293rd meeting
of Registration Board is required
Decision: Registration Board deferred for submission of stability study data as per
guidelines in 293rd meeting of Registration board and evaluation /consideration on its
own turn.
340. Name and address of manufacturer/ Reliance Pharma, Plot No.08, street No. S-8,
Applicant RCCI Industrial Estate, Rawat, Islamabad.
Brand Name + Dosage Form + Strength RELISONE Tablet 50 mg
Eperisone HCl Eq to Eprisoone
………………….50 mg
dated 06-03-2019.
Pharmacological Group SSRI
Type of Form Form-5
Finished product Specification Innovator’s Specification
Pack size & Demanded Price 3*10’s, As per SRO.
Approval status of product in Reference Expose 50mg film coated tablet, AIFA
Regulatory Authorities approved.
Me-too status Perispa 50mg tablets, Platinum pharma, Reg.
No. 039302.
GMP status GMP status/report within last 3 years not
provided
Remarks of the Evaluator Deficiency letter was
issued to firm and
asked to provide:
• Finished Product
specification not
provided or
undertaking to follow
innovator’s
specification.
• Firm has mentioned
Methylene chloride in
their master
formulation which is
prohibited.
• All the submitted
Form-5 Annexures
are without any
signature/stamp on
plain paper.
• GMP inspection
report conducted
within last 3 years is
not provided.
• Preregistration
variation fee challan.
Previous decision of 317th meeting: Deferred for following shortcomings;
1. Finished Product specification not provided or undertaking to follow innovator’s
specification.
2. Firm has mentioned Methylene chloride in their master formulation which is
prohibited.
3. All the submitted Form-5 Annexures are without any signature/stamp on plain paper.
4. GMP inspection report conducted within last 3 years is not provided.
5. Preregistration variation fee challan.
Reply of the Firm vide dairy No 24112 dated 26-08-2022
• Firm has submitted revised / signed Form -5 annexure along with finished good
specification as “Innovators specification “
• Firm has submitted copy of GMP certificate dated 11-08-2022 issued on the basis
of inspection conducted on 19-01-2022 (Capsule Section)
• Firm has submitted revised master formulation without methylene chloride.
Remarks :
Decision: Approved with innovators specification. Registration Board further decided
that registration letter shall be issued after submission of applicable fee of Rs.
30,000/=for pre-registration variation/correction of master formulation, as per
notification No.F.7-11/2012-B&A/DRAP dated 07- 05-2021.
341. Name and address of manufacturer/ Reliance Pharma, Plot No.08, street No. S-8,
Applicant RCCI Industrial Estate, Rawat, Islamabad.
Brand Name + Dosage Form + Strength RELIFOXINE CAPSULE 50 mg
Etifoxine Hcl ………………….5o mg
dated 06-03-2019.
Pharmacological Group SSRI
Type of Form Form-5
Finished product Specification Manufacturer’s Specification
Pack size & Demanded Price 3*10’s, As per SRO.
Approval status of product in Reference STRESAM, capsule”. ANSM, France approved
Me-too status Stresam capsule 50mg of M/s CCL Pharma
(Reg# 024595)
GMP status GMP status/report within last 3 years not
provided
Remarks of the Evaluator Deficiency letter was
issued to firm and
asked to provide:
• Finished Product
specification not
provided or
undertaking to follow
innovator’s
specification.
• All the submitted
Form-5 Annexures
are without any
signature/stamp on
plain paper.
• `GMP inspection
report conducted
within last 3 years is
not provided.
• Preregistration
variation fee challan.
th
Previous decision of 317 meeting: Deferred for following Shortcomings;
1. Finished Product specification not provided.
2. All the submitted Form-5 Annexures are without any signature/stamp on plain
paper.
3. GMP inspection report conducted within last 3 years is not provided.
4. Preregistration variation fee challan.
Reply of the Firm vide dairy No. 24111 dated 26-08-2022
• Firm has submitted revised / signed Form -5 annexure along with finished good
specification as “Innovators specification “
• Firm has submitted copy of GMP certificate dated 11-08-2022 issued on the basis
of inspection conducted on 19-01-2022 (Capsule Section )
Evaluators remarks :
Decision: Approved with innovators specification. Registration Board further decided
that registration letter shall be issued after submission of applicable fee of Rs.
30,000/=for pre-registration variation/correction of master formulation, as per
notification No.F.7-11/2012-B&A/DRAP dated 07- 05-2021.
342. Name and address of manufacturer / Pharmasol (Pvt) Ltd. Plot No. 549, Sundar
Applicant Industrial Estate, Raiwind Road, Lahore
Brand Name +Dosage Form + Strength Soquin Cream 4% w/w
Composition Each Gram of Cream Contains:
Hydroquinone ……………………………4gm
Diary No. Date of R& I & fee Dy. No. 12742 dated 06.03.2019
Rs. 20,000/- dated 06.03.2019
Pharmacological Group
Type of Form Form 5
Finished Product Specification The firm has claimed USP specs.
Pack size & Demanded Price 10g, 15g, 20g; As per SRO
Approval status of product in Reference Corrector 4% Cream by M/s VIVIER CANADA
Regulatory Authorities. INCORPORATED (Health Canada approved)
Status of the product on the website of Health
Canada is “Cancelled Post Market”
Me-too status Hydrofair Cream 4% by M/s Scotmann
(Reg#028278)
GMP status Firm has submitted copy of GMP certificate No.
140/2022-DRAP (AD-084433115014) dated 26-
08-2022 on the basis of inspection conducted on 22-
08-2022.
Remarks of the Evaluator. • The drug product specifications have not been
evaluated.
• Revise the label claim from
Hydroquinone…4gm to
Hydroquinone…40mg.
• You have not mentioned any emulsifying
agent. Clarify.
• Add packing process to the manufacturing
outlines.
• Revise the pharmacological group.
• For above revisions, submit the applicable fee
as per notification 7-11/2012-B&A/DRAP
dated 07.05.2021 and 13.07.2021.
Previous decision of 321st meeting: Deferred for followings;
• Revision of the label claim from Hydroquinone 4gm to Hydroquinone 40mg with
applicable fee as per notification 7-11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021.
• Justification for not mentioning any emulsifying agent.
• Revision of the manufacturing outlines with adding packing process.
• Revise the pharmacological group.
• Evidence of approval of applied formulation in reference regulatory
authorities/agencies which were adopted by the Registration Board in its 275th meeting.
Reply of the Firm vide dairy No.30795 dated 31-10-2022:
• Firm has submitted revised formulation as under, with preregistration variation fee
challan of PKR 30000/= vide slip No; 025524845 dated 28-10-2022
Soquin Cream 4 %
“Each Gram Contains:
Hydroquinone ……………………40 mg”
• Firm has submitted revised Form-5 mentioning Pharmacological group as
Depigmentation agent and finished product specifications as USP specifications.
• Firm has submitted revised masterformulation mentioning Cetomacrogol 100 as
emulsifying agent.
• Firm has submitted revised manufacturing outline and incorporated packaging
process.
Evaluator remarks : Status of the product on the website of Health Canada is “Cancelled
Post Market”
Decision: Registration Board deferred the case for submission of RRA reference as
submitted reference of product stands canceled post market.
Item No. VIII: Agenda of Evaluator-XVIII (Mr. Muneeb Ahmed)
Case No. 1 Priority Consideration based on Export.

Below mentioned products have been referred by PR section vide letter No. 1-6/2019-
PR (EFD) dated 06.10.2022 for consideration on priority as per direction of Authority in its 133rd
meeting for the firms who have achieved benchmark f export of more than 100000USD. Accordingly,
the details are as under
343. Name and address of M/s Sante (Pvt) Ltd., A-97 S.I.T.E. Super Highway
manufacture / Applicant Karachi
Brand Name + Dosage Form and Xebrom Ophthalmic Solution
Strength
Bromfenac Sodium Hydrate eq. to Bromfenac…….0.9
Dairy No. date of R &I fee Dy. No. 88 dated 31.01.2013 Rs. 20000/- and Rs.
30000/- dated 23.04.2014
Pharmacological Group Anti-inflammatory agents, non-steroids
Finished product specifications Manufacturer Specifications
Pack size and Demand Price Rs. 575 1.7ml bottle
Approval status of product in Yellox 0.9 mg/ml eye drops solution (EMA Approved)
Me-too-status Not provided
GMP Status
Remark of the Evaluator
Decision:
Manufacturer of API M/s Farmak A.S. Na Vlcinci 16/3 Klasterni Hradisko 77900
Olomouc Czech Republic
Description of Pack LDPE bottle of 5ml with LDPE Nozzle and HDPE Cap
Stability Storage Condition Accelerated: 40°C ± 25°C% RH
Real Time: 30°C ± 2°C / 35% ± 5%RH
Real Time: 6 Months
XEBROM OPHTHALMIC SOLUTION
Batch No. 007-SO7 007-SO8 007-SO9
Batch Size 5L 5L 5L
applications with stability study data of the approval of applications with stability study data
firm of the firm
2. Certificate of Analysis of API from both Firm has submitted copy of COA of the drug
API Manufacturer and Finished Product substance from API Manufacturer and COA by
manufacturer. them
3. Method used for analysis of API from both The firm has submitted method used for analysis
API Manufacturer and Finished Product of API from both API Manufacturer and Finished
manufacturer Product
manufacturer
4. Stability study data of API from API The firm has submitted stability study data of API
manufacturer from API manufacturer
5. Approval of API/ DML/GMP certificate of Firm has submitted copy of GMP certificate of API
API manufacturer issued by concerned manufacturer issued by concerned regulatory
regulatory authority.
6. Documents for the procurement of API with Firm has submitted the Airway bill and invoice but
approval from DRAP (in case of import). not DRAP attested.
7. Protocols followed for conduction of Firm has submitted protocols followed for
stability study conduction of stability study
8. Method used for analysis of FPP Firm has provided detailed method for analysis of
FPP
9. Drug-excipients compatibility studies The firm has submitted that formulation is
(where applicable) qualitatively same with the Innovator brand hence
the compatibility studies are not required.
(where applicable)
attested respective documents like chromatograms, raw data sheets, COA, summary
chromatograms, Raw data sheets, COA, data sheets for the stability studies
13. Compliance Record of HPLC software Firm has submitted certificate of compliance and
21CFR & audit trail reports on product audit trail reports for HPLC analysis for all the
stability chambers
Remarks:
The firm has addressed all the observations as reflected in the agenda vide response submitted dated
03.11.2022 Dy. No. 31576. Hence the keeping in view the response of the firm Board decided as
under:
Decision: Approved as per Innovator’s Specifications with following conditions before issuance
of registration:
i. Firm shall submit new brand name as applied name has resemblance with Innovator
brand name.
ii. As the firm has added specifications for antimicrobial preservative assay in Finished
product specifications, hence the aforesaid assay results shall be submitted for the next
time point along with method of analysis & chromatograms for confirmation.
344. Name and address of M/s Sante (Pvt) Ltd., A-97 S.I.T.E. Super Highway
manufacture / Applicant Karachi
Brand Name + Dosage Form and Nepac Forte 0.3% Ophthalmic suspension
Strength
Nepafenac (Sterile, Micronized)………..3mg
Dairy No. date of R &I fee Dy. No. 1128: 2-6-2016PKR 20,000/- 1-6-2016
Pharmacological Group Non-steroidal anti-inflammatory (Prodrug)
Type of form Form 5
Finished product specifications
Pack size and Demand Price 5ml: Rs. 1000/-
Approval status of product in Nevanac ophthalmic suspension by Novartis
Reference Regulatory Authorities (MHRA Approved)
Me-too-status ILevro Eye Drops of M/s Novartis Pharma Karachi
GMP Status
Remark of the Evaluator II
Decision:
Manufacturer of API M/s ArkGen Pharma Pvt Limited Plot No. 53-B Kohlar KIADB
Industrial Area Bidar-585 401
API Lot No. NEPFA00819
Description of Pack Plastic bottle of 5ml
Real Time: 30°C ± 2°C / 35% ± 5%RH
Real Time: 6 Months
NEPAC FORTE 0.3% OPHTHALMIC SUSPENSION
Batch No. 007-SO7 007-SO8 007-SO9
Batch Size 5L 5L 5L
firm
API Manufacturer and Finished Product substance from API Manufacturer and Finished
manufacturer. Product manufacturer.
manufacturer
4. Stability study data of API from API
manufacturer
5. Approval of API/ DML/GMP certificate of Firm has submitted copy of GMP certificate vide
API manufacturer issued by concerned No. DCD/SPL-1/CR-148/2021-22 dated
regulatory 16.06.2021 which is valid till one year issued by
authority of country of origin. drug Control Department Govt. of Karnataka.
6. Documents for the procurement of API with Firm has submitted the Airway bill and invoice but
approval from DRAP (in case of import). not DRAP attested.
7. Protocols followed for conduction of Firm has submitted protocols followed for
8. Method used for analysis of FPP Firm has provided detailed method for analysis of
FPP
9. Drug-excipients compatibility studies Not submitted
(where applicable)
10. Complete batch manufacturing record of
(where applicable)
attested respective documents like chromatograms, raw data sheets, COA, summary
chromatograms, Raw data sheets, COA, data sheets for the stability studies
13. Compliance Record of HPLC software Firm has submitted certificate of compliance and
21CFR & audit trail reports on product audit trail reports for HPLC analysis for all the
stability chambers
Evaluation by PEC:
Queries Reply
Invoice submitted for the import of API i.e. Firm has submitted the copy of DRAP Karachi
Nepafenac manufactured by M/s ArkGen Pharma attested invoice vide Dy. Bo. 12251 dated
Pvt Limited Bidar India is not attested by the 060.11.2019.
DRAP. Further another DRAP attested invoice for
import of API manufactured/ exported by
Hangzhou Zhongbao Imp & Exp. China is
submitted. This needs clarification.
Invoice submitted for the import of API i.e. Don’t consider these documents, it’s our alternate
Nepafenac manufactured by M/s ArkGen Pharma approved source for Nepac 0.1% ophthalmic
Pvt Limited Bidar India is not attested by the suspension (075809)
DRAP. Further another DRAP attested invoice for
import of API manufactured/ exported by
Hangzhou Zhongbao Imp & Exp. China is
submitted. This needs clarification.
Justification for using 3% overage. 3% overage is used to avoid transfer losses and
production loses in small scale stability batches, we
will review the overage percentage at the time of
commercial scale production.
The stability data provided for API does not reflect Firm has submitted commercial invoioce attested
that it has been provided by the API manufacturer. by AD I&E DRAP & stability data accelerated (6
Hence following needs to be submitted: months) and long term (60months) indicating the
i. Letter of authorization for provision of API batch size, batch number and container closure
from manufacturer i.e. M/s ArkGen Pharma systems along with performance of sterility testing.
Pvt Limited India.
ii. Stability data accelerated and long term
indicating the batch size, batch number and
container closure systems.
iii. Clarification for not performing sterility
testing during stability testing.
iv. Clarification required as 24 months of long
term data is provided, however the retest
period as per Certificate of analysis is 48
months (four years).
v. Justification for proposing retest period
rather shelf life as the API is known to be
(heat) labile.
API specifications proposed by you includes Identification and sterility method has been
identification, particle size determination and incorporated in API test method, however particle
sterility but procedure is not submitted. size determination complies as per manufacturer.
In stability batches you are proposing 1.7ml filled In stability batches we have used, we have used
volume in 5ml bottle but the innovator product 1.7ml pack size as per Innovator Ilevro by Alcon
contains 3ml filed volume in 5ml bottle. This having pack size of 1.7ml. However the proposed
needs justification. pack size will be 3ml as per other brands registered
by DRAP
Justification with suitable references of proposing Firm has submitted that they followed general
pH 4.0 to 8 in finished product specifications. Chapter of USP <771>.
Justification for not performing identity and assay Firm informed that they have used benzalkonium
of benzalkonium chloride and sodium edetate, chloride only as preservative and they are not using
particle size, osmolality, redispersibility, disodium edetate, however the formulation details
viscosity, uniformity of dosage unit and filled submitted indicates that 0.1mg/ml of disodium
volume being critical quality attributes of the edetate.
applied product. This needs to clarify with
references
Particle size test is justified with particulate matter
in ophthalmic solutions <789> benzalkonium
chloride assay, particle size, osmolality,
redispersibility, viscosity, uniformity of dosage
unit and filled volume were performed at the initial
stage. Justification of specifications for aforesaid
parameters is required.
Certificate of analysis (COA) submitted in respect Firm informed that Innovator Ilevro by Alcon has
of all three stability batches indicates storage storage conditions of 2-25C
conditions at 2-25oC. This needs to justified with
literature references/ Innovator product.
Batch size is mentioned as 2L on stability data This typo error, batch size is %5L
sheets, however master formula of 5L is provided.
Justification for not performing assay

of Firm submitted that they have performed assay at
preservatives in stability testing initial and final stage. Results have been submitted
but method of analysis along with chromatograms
are required for further confirmations.
Drug-excipients compatibility studies are not Firm informed that their formulation is same as
submitted, needs justification. Ilvero of Alcon i.e. Innovator.
Description & details regarding material of Firm has submitted the CoA of 10ml bottle of year
construction of container closure systems for 2015 however applied product is 5ml.
applied product needs to be submitted.
Under manufacturing process at 4.4 (addition of Firm informed that they have precise balance for
API) requires detailed elaboration regarding dispensing of small quantities having readability 0.
dispensing of 15.525gm of API from API 001g. Pictures have been provided.
container for each batch of 5L.
Justification of milling in manufacturing process Grinding of API has been performed for equal
is required as you have already used micronized distribution of particles in product. This procedure
API having particle size of 5um. Further after has been adopted for homogenization of
grinding purportedly for seven days at step 4 (as suspension and to improve the sustainability (not
per submitted manufacturing method) particle size for particle size reduction). As the API is sterile and
evaluation studies are not performed. This needs aseptically added into the grinding jar for milling,
to be responded with justification. it becomes difficult to sample the portion from the
jar due to sterility aspect as well as quantitation also
disturbed.
Validation studies are required that sterilization Firm has referred to provisions of general chapter
through moist heat/ autoclave at manufacturing of sterility testing of USP for compliance to
step 4.3 and 4.5 and sanitization of mixing tank at sterility parameters.
4.8 ensures sterility.
Record of Digital data logger for temperature and Firm has submitted the Record of Digital data
humidity monitoring of stability chambers (real logger for temperature and humidity monitoring of
time and accelerated). stability chambers
Pharmaceutical equivalence studies with the Firm submitted pharmaceutical equivalence studies
reference/ innovator product are required which against “Ilevro” of Novartis
are not provided.
Decision: Approved with Innovator’s specifications. The firm shall submit fee of Rs. 7500/- for
correction/pre-approval change in product specifications as per notification No.F.7-11/2012-
345. Name, address of Applicant / M/s. Pharmatec Pakistan (Private) Limited
Marketing Authorization Holder D-86/A, S.I.T.E., Karachi-75700
Tel: 021-32561155-8, Fax: 32561330
Name, address of Manufacturing site. M/s. Pharmatec Pakistan (Private) Limited
D-86/A, S.I.T.E., Karachi-75700
Tel: 021-32561155-8, Fax: 32561330
☐ Importer
☐ Export sale
Diaflo-Met 5/850mg Tablet
name
Active Pharmaceutical ingredient (API) Dapagliflozin ……..5mg (as Dapagliflozin
per unit Propanediol Monohydrate)
Metformin Hydrochloride……..850mg
Pharmaceutical form of applied drug Beige colored oval biconvex film coated tablets
plain from both sides.
Pharmacotherapeutic Group of (API) Combination of Oral Blood Glucose Lowering
drugs
In-house specifications
specifications
Proposed Pack size 14’s, 28’s, 56’s & 60’s
The status in reference regulatory XIGDUO 5mg/850mg film coated tablet by
authorities ASTRAZENECA UK Limited, MHRA Approved.
For generic drugs (me-too status) DAPLOZMET 5/850mg Tablet by M/s. CCL
Pharmaceutical (Pvt.) Limited, Reg. No. 106270
GMP status of the Finished product GMP certificate No. 32/2022-DRAP(K)
manufacturer Tablet (General) section is approved.
Name and address of API manufacturer. For Dapagliflozin: M/s. Shanghai Pharma Group
Changzhou Kony Pharmaceutical Co., Ltd .China
Daixi Street, Luoyang Town, Wujin District,
Changzhou City, Jiangsu Province 213105, China
For Metformin HCl: M/s. Ipca Laboratories
Limited
International House
48, Kandivli Industrial Estate,
Kandivli (West), Mumbai 400 067, India
India-400 067 Mumbai, Maharashtra
Module III (Drug Substance) Official monograph of Dapagliflozin Propanediol
Monohydrate is USP and Metformin Hydrochloride
is present in BP. The firm as submitted detail of
tests for impurities & related substances,
months.
months
For Dapagliflozin Propanediol Monohydrate:
Batches:(20PD256DMHT02, 20PD267DMHT03,
21PD042DMHT04 )
For Metformin HCl:
Batches:(9002ML2RMI,9003ML2RMI,
9004ML2RMI
comparative dissolution profile against the brand leader that is DAPA-MET
5/850mg Tablets by Hilton Pharma (Pvt.) Ltd,
Karachi, Pakistan by performing quality
tests(Identification, Assay, Dissolution, Hardness,
Disintegration Time, Friability, Content
uniformity).
that is DAPA-MET 5/850mg Tablets by Hilton
Pharma (Pvt.) Ltd, Karachi, Pakistan in Acid media
acceptable range.
validation/verification of product including System Suitability, Linearity, Accuracy,
precision, Specificity, Limit of Quantification,
Limit of Detection, Robustness.
Manufacturer of API M/s. Shanghai Pharma Group Changzhou Kony Pharmaceutical Co., Ltd
.China
API Lot No. For Metformin HCl: 2048ML2ARMI
Dapagliflozin Propanediol Monohydrate: DGF20180501
Description of Pack
Alu-Alu blister packed in unit carton (14’s)
Batch No. 20PD255DMHT02 21PD043DMHT03 21PD044DMHT04
No. of Batches 03
1. Reference of previous approval of Extract of DRB 289 Meeting reference is attached.
the firm (if any)
2. Approval of API/ DML/GMP certificate For Dapagliflozin Propanediol Monohydrate:
of API manufacturer issued by Copy of GMP certificate No. JS20180935 valid till
country of origin. For Metformin HCl:
Copy of GMP certificate No: NEW-WHO-
GMP/CERT/AD/104179/2021/11/37725
Valid till 27/08/2024.
3. Documents for the procurement of API For Dapagliflozin Propanediol Monohydrate:
with approval from DRAP (in case of • Form 6 of Licence No. 1850/18 DRAP(K) dated
import). 21/06/18 is submitted wherein the permission to
import API DAPAGLIFLOZIN
PROPANEDIOL MONOHYDRATE for the
granted.
• Commercial Invoice No. WIS180048 dated
05/06/2018
For Metformin HCl:
• Commercial Invoice No. MEG2021/1631969
dated 28/09/2020
documents like chromatograms,Raw
etc.
5. Compliance Record of HPLC software Certificate of compliance and Audit trial Reports
21CFR & audit trail reports on product are attached.
testing
6. Record of Digital data logger for Stability chamber data (real time and accelerated)
temperature and humidity monitoring of having monitoring of temperature and humidity are
stability chambers (real time and attached.
accelerated)
Remarks:
The firm has submitted the response to the observations as reflected in agenda vide reply submitted
on 04.11.2022 vide Dy. No. 31758. The firm has submitted long term stability data of sixty months
of three commercial scale batches for Zone IV-A conditions with retest period of two years.
346. Name, address of Applicant / M/s. Pharmatec Pakistan (Private) Limited
Marketing Authorization Holder D-86/A, S.I.T.E., Karachi-75700
Tel: 021-32561155-8, Fax: 32561330
Name, address of Manufacturing site. M/s. Pharmatec Pakistan (Private) Limited
D-86/A, S.I.T.E.,Karachi-75700
Tel: 021-32561155-8, Fax: 32561330
☐ Importer
☐ Export sale
Diaflo-Met 5/1000mg Tablet
name
Active Pharmaceutical ingredient Dapagliflozin……..5mg
(API) per unit (as Dapagliflozin Propanediol Monohydrate)
Metformin Hydrochloride………1000mg
Pharmaceutical form of applied drug Yellow color, oval shaped, Biconvex, Film coated,
and Plain from both sides.
Pharmacotherapeutic Group of (API) Combinations of Oral Blood Glucose Lowering
Drugs
In-house Specifications
specifications
Proposed Pack size 14’s, 28’s, 56’s & 60’s
The status in reference regulatory XIGDUO 5mg/1000mg Film coated Tablets by
authorities ASTRAZENECA UK LIMITED, MHRA
Approved.
For generic drugs (me-too status) DAPLOZMET 5/1000 mg Tablet by M/s. CCL
Pharmaceutical (Pvt.) Limited, Reg. No. 106271
GMP status of the Finished product GMP certificate No. 32/2022-DRAP(K)
manufacturer Tablet (General) section is approved.
Name and address of API manufacturer. For Dapagliflozin: M/s. Shanghai Pharma Group
Changzhou Kony Pharmaceutical Co., Ltd .China.
Daixi Street, Luoyang Town, Wujin District,
Changzhou City, Jiangsu Province 213105, China
For Metformin HCl: Ipca laboratories Limited,
International House
48, Kandivli Industrial Estate,
Kandivli (West), Mumbai 400 067, India
India-400 067 Mumbai, Maharashtra
Module III (Drug Substance) Official monograph of Dapagliflozin Propanediol
Monohydrate is present in USP and Metformin
HCL is in BP. The firm as submitted detail of
months
For Dapagliflozin Propanediol Monohydrate:
Batches:(D20161001, D20161001
20PD267DMHT03, 21PD042DMHT04)
For Metformin HCl:
Batches:(9002ML2RMI,9003ML2RMI,
9004ML2RMI
comparative dissolution profile against the brand leader that is DAPA-MET
5/1000mg Tablets by Hilton Pharma (Pvt.) Ltd,
Karachi, Pakistan by performing quality
tests(Identification, Assay, Dissolution, Hardness,
Disintegration Time, Friability, Content
uniformity).
that is DAPA-MET 5/1000mg Tablets by Hilton
Pharma (Pvt.) Ltd, Karachi, Pakistan in Acid media
acceptable range.
validation/verification of product including System Suitability, Linearity, Accuracy,
precision, Specificity, Limit of Quantification,
Limit of Detection, Robustness.
Manufacturer of API M/s. Shanghai Pharma Group Changzhou Kony Pharmaceutical Co., Ltd
.China
API Lot No. For Metformin HCl: 2048ML2ARMI
Dapagliflozin Propanediol Monohydrate: DGF20180501
Description of Pack
Alu-Alu blister packed in unit carton (14’s)
Batch No. 20PD256DMHT02 20PD267DMHT03 21PD042DMHT04
No. of Batches 03
7. Reference of previous approval of Extract of DRB 289 Meeting reference is attached.
the firm (if any)
8. Approval of API/ DML/GMP certificate For Dapagliflozin Propanediol Monohydrate:
of API manufacturer issued by Copy of GMP certificate No. JS20180935 valid till
country of origin. For Metformin HCl:
Copy of GMP certificate No: NEW-WHO-
GMP/CERT/AD/104179/2021/11/37725
9. Documents for the procurement of API For Dapagliflozin Propanediol Monohydrate:
with approval from DRAP (in case of • Form 6 of Licence No. 1850/18 DRAP(K) dated
import). 21/06/18 is submitted wherein the permission to
import API DAPAGLIFLOZIN
PROPANEDIOL MONOHYDRATE for the
granted.
• Commercial Invoice No. WIS180048 dated
05/06/2018
For Metformin HCl:
• Commercial Invoice No. MEG2021/1631969
dated 28/09/2020
documents like chromatograms,Raw
etc.
11. Compliance Record of HPLC software Certificate of compliance and Audit trial Reports
21CFR & audit trail reports on product are attached.
testing
12. Record of Digital data logger for Stability chamber data (real time and accelerated)
temperature and humidity monitoring of having monitoring of temperature and humidity are
stability chambers (real time and attached.
accelerated)
Stability data sheets of different batches submitted by the firm than those indicated in 3.2. S.7.1. for
Dapagliflozin.
Certificate of analysis of Dapagliflozin issued by API manufacturer is required as same is nit submitted
in the dossier.
Clarification is required regarding the copy of DRAP attested invoice submitted by you for import of
Dapagliflozin imported from M/s. Shanghai Pharma Group Changzhou Kony Pharmaceutical Co., Ltd.
China, DRAP vide invoice No. WIS180048 dated 05/06/2018 does not reflect the batch No, mfg. and
expiry date.
Justification is required as the Certificate of analysis issued by FPP manufacturer i.e. by you in respect
of Dapagliflozin for batch No. DGF20180501 indicates mfg. of May 2018 and retest date of
17.11.2021, however as per submitted stability data the API retest period is two years.
Remarks:
The firm has submitted the response to the observations as reflected in agenda vide reply submitted on
04.11.2022 vide Dy. No. 31758. The firm has submitted long term stability data of sixty months of
three commercial scale batches for Zone IV-A conditions with retest period of two years.
347. Name and address of M/s Seraph Pharmaceutical, Plot No. 210, Industrial
manufacture / Applicant triangle Kahuta road, Islamabad.
Brand Name + Dosage Form and Flozin 10mg Tablet
Strength
Empagliflozin IH …….10mg
Dairy No. date of R &I fee Form-5D Dy. No.11249 dated 01.03.2019 & Dy. No.
14273 dated 13.06.2022
Pharmacological Group Oral blood glucose lowering drugs

Pack size and Demand Price 14’s, 28’s, 56’s;
As per SRO
Approval status of product in Jardiance 10mg film coated tablet
Reference Regulatory Authorities Manufactured by Boehringer Ingelheim Pharma GmbH
& Co. KG. Germany
Me-too-status EMSYN Tablets 10mg
Manufactured by SEARLE (Karachi)
GMP Status
Decision:
Manufacturer of API Empagliflozin: HuaiNan Shunglong Pharmaceutical Co. Ltd.
Address: No. 9th YongXing Road, Huaninan economic and
Technological Development zone, Huaninan City, China
API Lot No. Empagliflozin: 20201201 & 20201204
Description of Pack Alu-Alu blister foil with unit carton
Real Time: 30°C ± 2°C / 65% ± 5%RH
Real Time: 6 Months
FLOZIN TABLET 10MG
Batch No. T 001 T 002 T 003
Date of Initiation 18 – 05 -2021 18 – 05 -2021 18 – 05 -2021
applications with stability study data of the product Dexpro 30mg DDR Capsule which was
firm conducted on 11th June, 2018 and was presented in
285st meeting of Registration Board held on 03-04th
October, 2018.
confirmed.
• The firm has 21 CFR compliant HPLC software
• The firm possesses stability chambers with digital
data loggers.
2. Certificate of Analysis of API from both Firm has submitted copy of COA of the drug substance
API Manufacturer and Finished Product from both API Manufacturer and Finished Product
3. Method used for analysis of API from Firm has submitted copy of method used for analysis
both API Manufacturer and Finished of API from both API Manufacturer and Finished
Product Product manufacturer
manufacturer
4. Stability study data of API from API Empagliflozin: The submitted stability data as per
manufacturer zone IV-A conditions. The real time stability data is
till 24 months.
Firm has submitted both accelerated (40°C ± 2°C &
75±5%RH) stability studies & long term (30°C ± 2°C
& 65±5%RH) stability studies reports of three batches
till 24 months.
5. Approval of API/ DML/GMP certificate Empagliflozin: Firm has submitted copy of DML
of API manufacturer issued by concerned certificate (No. Wan 20160342) issued by Anhui Food
regulatory and Drug Administration, China. The certificate is
authority of country of origin. valid till 30-04-2021. Copy of GMP certificate
(AH20180451) issued by CFDA, Valid up to
07.04.2023.
6. Documents for the procurement of API Empagliflozin: Firm has submitted copy of
with approval from DRAP (in case of commercial invoice cleared dated 08-02-2021
import). specifying import of 100g Empagliflozin. The invoice
is signed by AD (I&E) DRAP Islamabad office dated
02-04-2021. Second lot of Empagliflozin (lot no.
20201204) 100g, The invoice is signed by AD (I&E)
DRAP Islamabad, on 27-05-2021.
7. Protocols followed for conduction of Firm has submitted protocols followed for conduction
stability study of stability study
8. Method used for analysis of FPP Firm has provided detailed method for analysis of FPP
9. Drug-excipients compatibility studies Firm has used same excipients as that of the
(where applicable) innovator’s product therefore compatibility studies are
not required
10. Complete batch manufacturing record of Firm has provided Batch Manufacturing Record for all
three stability batches. the batches
11. Record of comparative dissolution data Firm has submitted CDP for 10mg with EMSYN
(where applicable) 10mg tablet.
12. Data of 03 batches will be supported by Firm has submitted documents like chromatograms,
attested respective documents like raw data sheets, COA, summary data sheets for the
chromatograms, Raw data sheets, COA, stability studies
13. Compliance Record of HPLC software Firm has submitted certificate of compliance and audit
21CFR & audit trail reports on product trail reports for HPLC analysis for all the three batches.
testing.
temperature and humidity monitoring of both stability chambers for accelerated as well as real
stability chambers time stability studies.
Evaluation by PEC:
Manufacturer will place first three production batches on long term stability studies throughout
proposed shelf life and on accelerated studies for six months.
348. Name and address of M/s Seraph Pharmaceutical, Plot No. 210, Industrial
manufacture / Applicant triangle Kahuta road, Islamabad.
Brand Name + Dosage Form Flozin 25mg Tablet
and Strength
Empagliflozin IH …….25mg
Dairy No. date of R &I fee Form-5D Dy. No. 11249 dated: 05.03.2019 20000/-
Dy. No. 14274 dated 19.06.2022
Pharmacological Group Oral blood glucose lowering drugs
Approval status of product in Jardiance 25mg film coated tablet manufactured by
Reference Regulatory Boehringer Ingelheim Pharma GmbH & Co. KG. Germany
Authorities
Me-too-status Diampa Tablets 25mg
Manufactured by Getz Pharma
GMP Status
Decision:
Manufacturer of API Empagliflozin: HuaiNan Shunglong Pharmaceutical co. Ltd.
Address: No. 9th YongXing Road, Huaninan economic and
Technological Development zone, Huaninan City, China
API Lot No. Empagliflozin: 20201201 & 20201204
Description of Pack Alu-Alu blister foil with unit carton
Real Time: 30°C ± 2°C / 65% ± 5%RH
Real Time: 6 Months
FLOZIN TABLET 25MG
Batch No. T 001 T 002 T 003
Date of Initiation 18 – 05 -2021 18 – 05 -2021 18 – 05 -2021
applications with stability study data of product Dexpro 30mg DDR Capsule which was
the firm conducted on 11th June, 2018 and was presented in 285st
meeting of Registration Board held on 03-04th October,
2018.
confirmed.
• The firm has 21 CFR compliant HPLC software
• The firm possesses stability chambers with digital
data loggers.
2. Certificate of Analysis of API from Firm has submitted copy of COA of the drug substance
both API Manufacturer and Finished from both API Manufacturer and Finished Product
manufacturer.
3. Method used for analysis of API from Firm has submitted copy of method used for analysis of
both API Manufacturer and Finished API from both API Manufacturer and Finished Product
manufacturer
4. Stability study data of API from API Empagliflozin: The submitted stability data as per zone
manufacturer IV-A conditions. The real time stability data is till 24
months.
Firm has submitted both accelerated (40°C ± 2°C &
75±5%RH) stability studies & long term (30°C ± 2°C &
65±5%RH) stability studies reports of three batches till
24 months.
5. Approval of API/ DML/GMP certificate Empagliflozin: Firm has submitted copy of DML
of API manufacturer issued by certificate (No. Wan 20160342) issued by Anhui Food
concerned regulatory and Drug Administration, China. The certificate is valid
authority of country of origin. till 30-04-2021. Copy of GMP certificate (No.
s1[2018]79) issued by Anhui Food and Drug
Administration, China, Valid up to 28-09-2023.
6. Documents for the procurement of API Empagliflozin: Firm has submitted copy of commercial
with approval from DRAP (in case of invoice cleared dated 08-02-2021 specifying import of
import). 100g Empagliflozin. The invoice is signed by AD (I&E)
DRAP Islamabad office dated 02-04-2021. Second lot
of Empagliflozin (lot no. 20201204) 100g, The invoice
is signed by AD (I&E) DRAP Islamabad, on 27-05-
2021.
7. Protocols followed for conduction of Firm has submitted protocols followed for conduction of
stability study stability study
8. Method used for analysis of FPP Firm has provided detailed method for analysis of FPP
9. Drug-excipients compatibility studies Firm has used same excipients as that of the innovator’s
(where applicable) product therefore compatibility studies are not required
10. Complete batch manufacturing record of Firm has provided Batch Manufacturing Record for all
three stability batches. the batches
11. Record of comparative dissolution data Firm has submitted CDP for 25mg with Diampa 25mg
(where applicable) tablet.
12. Data of 03 batches will be supported by Firm has submitted documents like chromatograms, raw
attested respective documents like data sheets, COA, summary data sheets for the stability
chromatograms, Raw data sheets, COA, studies
13. Compliance Record of HPLC software Firm has submitted certificate of compliance and audit
21CFR & audit trail reports on product trail reports for HPLC analysis for all the three batches.
testing.
14. Record of Digital data logger for Firm has submitted record of digital data logger for both
temperature and humidity monitoring of stability chambers for accelerated as well as real time
stability chambers stability studies.
Evaluation by PEC:
349. Name, address of Applicant / M/s Seraph Pharmaceutical, Plot no. 210,
Marketing Authorization Holder Industrial Triangle Kahuta road. Islamabad.
Name, address of Manufacturing site. M/s Seraph Pharmaceutical, Plot no. 210, Industrial
Triangle Kahuta road. Islamabad.
☐ Importer
☐ Export sale
The proposed proprietary name / brand SERROX 250mg tablet
name
Strength / concentration of drug of Each dispersible tablet contains:
Active Pharmaceutical ingredient (API) Deferasirox …….250mg
per unit
Pharmaceutical form of applied drug Dispersible Tablets
Pharmacotherapeutic Group of (API) Iron Chelating agent
Innovator Specification
specifications
The status in reference regulatory Exjade Tablets 250mg M/s Novartis, USFDA
For generic drugs (me-too status) Dasirox Dispersible Tablets 250mg, CCL
Pharmaceutical, Lahore.
GMP status of the Finished product GMP certificate granted on 11/07/2019
Name and address of API manufacturer. M/s BDR Lifesciences Private Limited, R.S. No.
578, near Effluent channel road, Village-Luna Ta-
Padra, Dist.-Vadodara, Gujarat, India.
Module III (Drug Substance) In house product analytical method was developed.
substance
Batches: (001, 002 & 003)
(including dissolution testing, batch analysis and
product.
comparative dissolution profile against the brand that is Dasirox 250mg tablet by
CCL Pharmaceutical, Lahore. performing quality
tests (Identification, Assay, Dissolution, Uniformity
of dosage form).
is Dasirox 250mg tablet. Tablet by CCL
Pharmaceutical in Acid media (pH 1.0-1.2) &
Phosphate Buffer (pH 6.8). The values for f1 and f2
are in the acceptable range.
specificity.
Manufacturer of API M/s BDR Lifesciences Private Limited, R.S. No. 578, near Effluent
channel road, Village-Luna Ta-Padra, Dist.-Vadodara, Gujarat, India.
API Lot No. DFZP200013
Description of Pack
Batch No. 001 002 003
No. of Batches 03
1. Reference of previous approval of The firm has submitted previous approval of
applications with stability study data of document with stability data.
the firm (if any)
2. Approval of API/ DML/GMP certificate Firm has submitted the copy of Eudra GMP
of API manufacturer issued by certificate of the API manufacturer.
country of origin.
3. Documents for the procurement of API Firm has submitted the copy of import invoice vide
with approval from DRAP (in case of No.EX/BDR/196/20-21 dated 27.07.2020
import).
4. Data of stability batches will be Firm has submitted data of stability batches
supported by attested respective supported by attested respective documents like
documents like chromatograms, chromatograms,
Raw data sheets, COA, summary data Raw data sheets, COA, summary data sheets.
sheets etc.
5. Compliance Record of HPLC software HPLC is not CFR compliant as per statement of the
21CFR & audit trail reports on product firm.
testing
stability chambers (real time and and accelerated)
accelerated)
350. Name, address of Applicant / M/s Seraph Pharmaceutical, Plot no. 210, Industrial
Marketing Authorization Holder Triangle Kahuta road. Islamabad.
Name, address of Manufacturing M/s Seraph Pharmaceutical, Plot no. 210, Industrial
site. Triangle Kahuta road. Islamabad.
☐ Importer
SERROX 500mg tablet
brand name
Strength / concentration of drug of Each dispersible tablet contains:
Active Pharmaceutical ingredient Deferasirox …….500mg
(API) per unit
Dispersible Tablets
drug
Iron Chelating agent
(API)
specifications
The status in reference regulatory Exjade Tablets 250mg M/s Novartis, USFDA
For generic drugs (me-too status) Dasirox Dispersible Tablets 500mg, CCL
Pharmaceutical, Lahore.
Name and address of API M/s BDR Lifesciences Private Limited, R.S. No. 578,
manufacturer. near Effluent channel road, Village-Luna Ta-Padra,
Dist.-Vadodara, Gujarat, India.
submitted.
Module III (Drug Substance) In house product analytical method was developed. The
firm as submitted detail of nomenclature, structure,
and controls, specifications, analytical procedures and
Batches: (004, 005 & 006)
product.
comparative dissolution profile against the brand that is Dasirox 500mg tablet by CCL
Pharmaceutical, Lahore. performing quality tests
dosage form).
Dasirox 500mg tablet. Tablet by CCL Pharmaceutical in
Acid media (pH 1.0-1.2) & Phosphate Buffer (pH 6.8).
Manufacturer of API M/s BDR Lifesciences Private Limited, R.S. No. 578, near Effluent
channel road, Village-Luna Ta-Padra, Dist.-Vadodara, Gujarat, India.
API Lot No. DFZP200013
Description of Pack
Batch No. 004 005 006
No. of Batches 03
1. Reference of previous approval of The firm has submitted previous approval of document
applications with stability study data with stability data.
2. Approval of API/ DML/GMP Firm has submitted the copy of Eudra GMP certificate
certificate of API manufacturer of the API manufacturer.
3. Documents for the procurement of Firm has submitted the import documents of API.
case of import).
documents like chromatograms, Raw data sheets, COA, summary data sheets.
data sheets etc.
5. Compliance Record of HPLC HPLC is not CFR compliant as per statement of the firm.
on product testing
temperature and humidity humidity monitoring of stability chambers (real time and
monitoring of stability chambers accelerated) is submitted by the firm.
350. Name, address of Applicant / Marketing M/s Seraph Pharmaceutical, Plot no. 210, Industrial
Authorization Holder Triangle Kahuta road. Islamabad.
☐ Importer
☐ Export sale
KALSEPH 10mg tablet
name
Active Pharmaceutical ingredient (API) Vonoprazan fumarate eq. to Vonoprazan
per unit ………10mg
Pharmaceutical form of applied drug Tablets

specifications
The status in reference regulatory Takecab Tablet 10mg, Takeda Pharmaceutical,
authorities Japan (PMDA)
For generic drugs (me-too status) Vonozan Tablet 10mg, by M/s Getz Pharma (Pvt.)
Ltd
Name and address of API manufacturer. Jiangxi Synergy Pharmaceutical Co., Ltd. Jiangxi
Fengxin Industrial Park, Fengxin, 330700, Jiangxi
substance
Batches: (T001,T002 & T003)
product.
comparative dissolution profile against the brand that is Vonozan 10mg tablet by
Getz Pharma. Performing quality tests
dosage form).
is Vonozan 10mg tablet. Tablet by Getz
specificity.
Manufacturer of API Jiangxi Synergy Pharmaceutical Co., Ltd. Jiangxi Fengxin Industrial Park,
Fengxin, 330700, Jiangxi Province, P.R. China
Description of Pack
No. of Batches 03
the firm (if any) Dexpro 30 & 60mg Capsules approved in 285th
meeting of Registration Board.
Novel 800mg Tablet approved in 288th meeting of
Registration Board.
2. Approval of API/ DML/GMP certificate Copy of Pharmaceutical Production License vide No.
of API manufacturer issued by concerned GAN 20160125 dated 27.11.2020 issued by Jiangxi
regulatory authority of country of origin. Provincial Medical Products Administration China
valid till 26.11.2025
3. Documents for the procurement of API Firm has submitted DRAP attested invoice vide No.
with approval from DRAP (in case of JXSG210904 dated 13.10.2021
import).
4. Data of stability batches will be The firm has submitted the stability batches will be
documents like chromatograms, chromatograms, Raw data sheets, COA, summary
Raw data sheets, COA, summary data data sheets
sheets etc.
5. Compliance Record of HPLC software As per statement of the firm the HPLC system used
21CFR & audit trail reports on product in the analysis is not CFR compliant
testing
6. Record of Digital data logger for The firm has submitted record of Digital data logger
temperature and humidity monitoring of for temperature and humidity monitoring of stability
accelerated)
351. Name, address of Applicant / M/s Seraph Pharmaceutical, Plot no. 210,
Marketing Authorization Holder Industrial Triangle Kahuta road. Islamabad.
☐ Importer
☐ Export sale
KALSEPH 20mg tablet
name
Active Pharmaceutical ingredient (API) Vonoprazan fumarate eq. to Vonoprazan
per unit ………20mg
Pharmaceutical form of applied drug Tablets

specifications
The status in reference regulatory Takecab Tablet 20mg, Takeda Pharmaceutical,
authorities Japan (PMDA)
For generic drugs (me-too status) Vonozan Tablet 20mg, by M/s Getz Pharma (Pvt.)
Ltd
Name and address of API manufacturer. Jiangxi Synergy Pharmaceutical Co., Ltd. Jiangxi
Fengxin Industrial Park, Fengxin, 330700, Jiangxi
substance
Batches: (001, 002 & 003)
product.
comparative dissolution profile against the brand that is Vonozan 20mg tablet by
Getz Pharma. Performing quality tests
dosage form).
is Vonozan 20mg tablet. Tablet by Getz
specificity.
Manufacturer of API Jiangxi Synergy Pharmaceutical Co., Ltd. Jiangxi Fengxin Industrial Park,
Fengxin, 330700, Jiangxi Province, P.R. China
Description of Pack
No. of Batches 03
the firm (if any) Dexpro 30 & 60mg Capsules approved in 285th
meeting of Registration Board.
Novel 800mg Tablet approved in 288th meeting of
Registration Board.
2. Approval of API/ DML/GMP certificate Copy of Pharmaceutical Production License vide No.
of API manufacturer issued by concerned GAN 20160125 dated 27.11.2020 issued by Jiangxi
regulatory authority of country of origin. Provincial Medical Products Administration China
3. Documents for the procurement of API Firm has submitted DRAP attested invoice vide No.
with approval from DRAP (in case of JXSG210904 dated 13.10.2021 for batch No.
import). 20210801BD.
4. Data of stability batches will be The firm has submitted the stability batches will be
documents like chromatograms, chromatograms, Raw data sheets, COA, summary
Raw data sheets, COA, summary data data sheets
sheets etc.
5. Compliance Record of HPLC software As per statement of the firm the HPLC system used
21CFR & audit trail reports on product in the analysis is not CFR compliant
testing
accelerated)
352. Name and address of M/s English Pharmaceutical Industries,
manufacture / Applicant Link Kattar Band Road, Thokar Niaz Baig Lahore.
Brand Name + Dosage Form and Zarox 5mg Tablet
Strength
Composition Each tablet contains: Metolazone……….5mg
Dairy No. date of R &I fee Dy.No.20434; 08-11-2017; Rs.20,000/- (08-11-2017)
Pharmacological Group (Diuretic/saluretic/antihypertensive drug of the
quinazoline class)
Approval status of product in Zaroxolyn Tablet 5mg of (USFDA approved)
Me-too-status
GMP Status Firm has submitted copy of GMP certificate dated 17-08-
2022
Decision:
Manufacturer of API M/s Centaur Pharmaceuticals Pvt Limited. Plot No. 75,76 & 76/1
Chikhloli MIDC Ambernath (W) Dist. Thane 421 501 Maharashtra
India.
API Lot No. 1803604P
Description of Pack Alu-Alu blister of 1x10’s
Real Time: 30°C ± 2°C / 65% ± 5%RH
Real Time: 6 Months
ZAROX 5MG TABLET
Batch No. MLT 001 MLT 003 MLT 005
Batch Size 2000 2000 2000
Date of Initiation 08-10-2019 15.10.2019 22.10.2019
1. Reference of previous approval of Not provided.
firm
API Manufacturer and Finished Product substance from API Manufacturer dated 04.07.2018
manufacturer. and COA by FPP manufacturer dated: 24.10.2018
3. Method used for analysis of API from both The API manufacturer has provided the BP specs
API Manufacturer and Finished Product and firm will use USP specifications.
manufacturer
manufacturer from API manufacturer.
5. Approval of API/ DML/GMP certificate of The firm has submitted the Eudra GMP certificate of
API manufacturer issued by concerned the manufacturer issued on 14.08.2018
regulatory
Firm has submitted the copy of DRAP attested
approval from DRAP (in case of import). invoice vide No. CP/EXP/C?297/18-19 dated
21.08.2018.
stability study
8. Method used for analysis of FPP The firm will follow USP monograph.
9. Drug-excipients compatibility studies Same qualitative composition as Innovator.
(where applicable)
10. Complete batch manufacturing record of Submitted.
11. Record of comparative dissolution data Submitted.
(where applicable)
13. Compliance Record of HPLC software The has submitted audit trail reports.
testing.
stability chambers
Remarks:
Decision: Approved with USP Specifications.
Brand Name + Dosage Form and Zarox 10mg Tablet
Strength
Metolazone……….10mg
Dairy No. date of R &I fee Dy.No.20435; 08-11-2017;
Rs.20,000/- (08-11-2017)
quinazoline class)
Approval status of product in Zaroxolyn Tablet 10mg of (USFDA approved)
Me-too-status
2022
Decision:
Manufacturer of API M/s Centaur Pharmaceuticals Pvt Limited. Plot No. 75,76 & 76/1
Chikhloli MIDC Ambernath (W) Dist. Thane 421 501 Maharashtra
India.
API Lot No. 1803604P
Real Time: 30°C ± 2°C / 65% ± 5%RH
Real Time: 6 Months
ZAROX 5MG TABLET
Batch No. MLT 002 MLT 004 MLT 006
Batch Size 2000 2000 2000
firm
API Manufacturer and Finished Product substance from API Manufacturer dated 04.07.2018
manufacturer. and COA by FPP manufacturer dated: 24.10.2018
3. Method used for analysis of API from both The API manufacturer has provided the BP specs
API Manufacturer and Finished Product and firm will use USP specifications.
manufacturer
manufacturer from API manufacturer.
5. Approval of API/ DML/GMP certificate of The firm has submitted the Eudra GMP certificate of
API manufacturer issued by concerned the manufacturer issued on 14.08.2018
regulatory
6. Documents for the procurement of API with Firm has submitted the copy of DRAP attested
approval from DRAP (in case of import). invoice vide No. CP/EXP/C?297/18-19 dated
21.08.2018.
stability study
8. Method used for analysis of FPP The firm will follow USP monograph.
9. Drug-excipients compatibility studies Same qualitative composition as Innovator.
(where applicable)
10. Complete batch manufacturing record of Submitted.
11. Record of comparative dissolution data Submitted.
(where applicable)
13. Compliance Record of HPLC software The has submitted audit trail reports.
testing.
stability chambers
Remarks:
Decision: Approved with USP Specifications.
Brand Name + Dosage Form and Renvel 800mg Tablet
Strength
Sevelamer Carbonate……….800mg
Dairy No. date of R &I fee Dy.No.20433; 08-11-2017;
Rs.20,000/- (08-11-2017)
quinazoline class)
Finished product specifications Manufacturer Specifications
Approval status of product in Renvela (USFDA Approved)
Me-too-status Genovel Tablets 800mg M/s Genome Pharmaceuticals
Hattar.
2022
Decision:
Manufacturer of API Apothecon Pharmaceuticals Pvt Limited, Plot No. 1134 to 1137,
1143B, 1144A, 1144B and 1138A & 1138B Padra Jambusar Highway
Tal Padra Dabhasa Vadodara Gujarat State India
API Lot No. DS185/008/05/21
Real Time: 30°C ± 2°C / 65% ± 5%RH
Real Time: 6 Months
RENVEL 800MG TABLET
Batch No. EP22-011-S1 EP22-011-S2 EP22-011-S3
Batch Size 2500 2500 2500
firm
API Manufacturer and Finished Product substance from API Manufacturer vide lot No.
manufacturer. DS185/008/05/21
3. Method used for analysis of API from both Firm has submitted the method used for analysis of
API Manufacturer and Finished Product API from both API Manufacturer and Finished
manufacturer Product manufacturer
4. Stability study data of API from API Long term data is submitted for three batches.
manufacturer
5. Approval of API/ DML/GMP certificate of GMP certificate of API manufacturer issued by the
API manufacturer issued by concerned concerned regulatory authority is submitted.
regulatory
6. Documents for the procurement of API with Firm has submitted the copy of DRAP attested
approval from DRAP (in case of import). invoice vide No. APO/21-22 dated 09.12.2021.
7. Protocols followed for conduction of Firm has submitted the protocols followed for
8. Method used for analysis of FPP Method used for analysis of FPP
9. Drug-excipients compatibility studies Not applicable
(where applicable)
10. Complete batch manufacturing record of The firm has submitted complete batch
three stability batches. manufacturing record of three stability batches
11. Record of comparative dissolution data Not applicable
(where applicable)
12. Data of 03 batches will be supported by IR spectra for submitted, the assay for titratable
attested respective documents like amine by potentiometric titration.
13. Compliance Record of HPLC software Not applicable
testing.
stability chambers chambers (real time and accelerated)
Evaluation by PEC:
Case No. 2 Routine Cases of Form 5F

355. Name, address of Applicant / M/s Global Pharmaceuticals Pvt Limited, Plot No.
Marketing Authorization Holder 204-205, Industrial Triangle Kahuta Road Islamabad.
Name, address of Manufacturing M/s Global Pharmaceuticals Pvt Limited, Plot No. 204-
site. 205, Industrial Triangle Kahuta Road Islamabad.
☐ Importer
Dy. No. and date of submission Dy. No. 28734 dated 20.10.2021
Details of fee submitted PKR 30000/- dated 13.07.2021
INCRIT-M XR 50/500mg Tablet
brand name
Active Pharmaceutical ingredient Sitagliptin as phosphate monohydrate…50mg
(API) per unit Metformin HCl (Extended Release)….500mg
Film Coated Tablet
drug
Anti-Diabetic
(API)
As per Innovators Specifications
specifications

Janumet XR of Merck Sharp & Dhome USA
authorities
For generic drugs (me-too status) Tagipmet XR of Highnoon Labs Lahore
GMP status of the Finished GMP certificate was issued to the firm by DRAP
product manufacturer Islamabad dated 28.12.2018 based on inspection dated
24.10.2018
Name and address of API Sitagliptin Phosphate Monohydrate
manufacturer. M/s Anhui Haikang Pharmaceutical Co., No.21
Huancheng West Road Daguan District Anqing Anhui
China
Metformin HCl
M/s Aarti Drugs Limited Plot No. 211-2013 Road No. 2
GIDC Sarigam District Valsad Gujarat India.
studies of drug substance and drug product is submitted.
Module III (Drug Substance) Firm has submitted detail of nomenclature, structure,
controls, tests for impurities specifications, analytical
procedures, batch analysis and justification of
specifications, analytical procedure (including dissolution
testing) and batch analysis and justification of
comparative dissolution profile against the reference product Janumet XR Tablets
CDP has been performed against the aforesaid brand in
three media. The f2 value are in the acceptable range.
Analytical method Method validation studies have been submitted.
Manufacturer of API Sitagliptin Phosphate Monohydrate
M/s Anhui Haikang Pharmaceutical Co., No.21
China
Metformin HCl
API Lot No. Sitagliptin Phosphate Monohydrate
20050203 Mfg date: 02.05.2020 retest date date:
01.05.2022
Metformin HCl
MEF/10030953 Mfg. date: 03.2020 Exp. Date: 02.2025
Description of Pack
Alu- Alu blister packed in unit carton (14’s)
Real Time: 0, 3, 6, 9, 12, 24 (Months)
Batch No. ST21D001 ST21D002 ST21D003
Date of Initiation 03.2023 03.2023 03.2023
No. of Batches 03
1. Reference of previous approval of The firm submitted reference of Promig Plus Tablets 375/
applications with stability study 20mg approved in 289th meeting of Registration Board
2. Approval of API/ DML/GMP Sitagliptin Phosphate Monohydrate
certificate of API manufacturer Copy of DML issued by Anhui Provincial drug
issued by concerned regulatory Administration.
authority of country of origin. Metformin HCl
Copy of GMP certificate issued by Food and Drug Control
Administration Gujarat State India
3. Documents for the procurement of The firm has submitted copy of DRAP attested invoice
API with approval from DRAP (in vide No. CI No: WD20200427-1 cleared on dated
case of import). 18.06.2020 of Sitagliptin Phosphate Monohydrate and
DRAP attested invoice vide No. EXP/302/20321 for
Metformin HCl cleared on 05.08. 2020.
data sheets etc.
5. Compliance Record of HPLC Provided
6. Record of Digital data logger for Provided
Boxed warning regarding Lactic Acidosis
Shortcomings:
Query Reply
Propyl Gallate is added in formulation in The firm informed that Propyl Gallate antioxidant will
metformin core as antioxidant, justification used in both solid and liquid phase to prevent
needs to be submitted with literature/ oxidation/free radical reaction.
innovator product references. The use of propyl gallate in core hinder the Metformin
hydrochloride acidic activity to produce free radical chain
reaction in provided condition of tablet drug layering via
coating. Structural study of metformin and propyl Gallate
shows, propyl gallate as an antioxidant reduces and
prevents oxidation of Metformin HCl, as shown below.
Nothing the dimethylamine moiety of metformin, this is
convenient sire for activity of metformin. This N-C bond
can be made by nucleophilic attack of dimethylamine at
the electrophilic nitrile carbon of cyanoguanidine. In fact,
this is how metformin’s act. There are various patented
procedures which differ in reaction conditions and
purification strategy, but almost all involve reacting the
hydrochloride salt of dimethylamine with
cyanoguanidine, so we use propyl Gallate with metformin
in sold. Propyl Gallate quantum chemistry and
computational kinetics study on the reactivity of propyl
Gallate towards H, Ooh, OOCH3 and OCHCH2 radicals,
in aqueous and lipid. As per literature study it was also
found propyl Gallate as antioxidant optionally used in
core and solution for coating.
However, the market composition of the innovator as
approved by USFDA is as detailed below,
Stability data of three months is provided, Firm has submitted the additional stability data.
additional data needs to be submitted.

Regsitration Board further decided as under:
i. The firm shall market the product as per Innovator product composition i.e. Janumet
XR including propyl gallate in its formulation as antioxidant
ii. Propyl gallate assay shall be added in finished product specifications.
Moreoever the Board advised PE&R Division to issue an advisory to the industry to follow the
composition of Janumet XR and propyl gallate assay for already registered products.
☐ Importer
/ brand name
of Active Pharmaceutical Sitagliptin as phosphate monohydrate…50mg
ingredient (API) per unit Metformin HCl (Extended Release)….1000mg
Film Coated Tablet
drug
Anti-Diabetic
(API)
specifications

Tagipmet XR of Highnoon Labs Lahore
status)
24.10.2018
China
Metformin HCl
China
Metformin HCl
01.05.2022
Metformin HCl
Description of Pack
Real Time: 0, 3, 6, 9, 12, 24 (Months)
No. of Batches 03
certificate of API manufacturer Copy of DML issued by Anhui Provincial drug
data sheets etc.
Shortcomings & reply of the firm:
Same as INCRIT-M XR 50/500mg Tablet
XR and submit the data of 1st commercial batch.
☐ Importer
/ brand name
of Active Pharmaceutical Sitagliptin as phosphate monohydrate…100mg
ingredient (API) per unit Metformin HCl (Extended Release)….1000mg
Film Coated Tablet
drug
Anti-Diabetic
(API)
specifications

Tagipmet XR of Highnoon Labs Lahore
status)
24.10.2018
China
Metformin HCl
China
Metformin HCl
01.05.2022
Metformin HCl
Description of Pack
Real Time: 0, 3, 6, 9, 12, 24 (Months)
No. of Batches 03
certificate of API manufacturer Copy of DML issued by Anhui Provincial Drug
data sheets etc.
Shortcomings & response of the firm:
Same as INCRIT-M XR 50/500mg Tablet
XR and submit the data of 1st commercial batch.
358. Name, address of Applicant / M/s Sohail Corporation Plot No. 474 Siraj Colony
Importer Moosa Lane Karachi.
Details of Drug Sale License of Drug License by the way of wholesale vide No.
importer DHODSK(Drug)/-433/- dated 01.012.2020 valid till 19-
11-2022
Name and address of marketing M/s Anhui Chengsi Pharmaceuticals Co., Ltd, No. 5068
authorization holder (abroad) Huaishang Road Bengbu Anhui China.
Name, address of manufacturer(s) M/s Anhui Chengsi Pharmaceuticals Co., Ltd, No. 5068
Huaishang Road Bengbu Anhui China.
Detail of certificates attached GMP: Copy of GMP certificate issued by CFDA vide No.
(CoPP, Freesale certificate, GMP CN20160035 valid till 08.03.2021.
certificate)
Details of letter of authorization / Firm has submitted copy of agency agreement.
sole agency agreement
☒ Importer
For imported products, specify one ☒ Finished Pharmaceutical product import
the these ☐ Buk import and local repackaging
☐ Buk import and local repackaging for export purpose
only
Details of fee submitted PKR 100000/- dated 07.04.2021 and 50000/- dated
07.06.2021.
The proposed proprietary name / LINCOMYCIN HYDROCHLORIDE INJECTION
brand name 600MG/2ML
Strength / concentration of drug of Each ampoule of 2ml contains:
Active Pharmaceutical ingredient Lincomycin HCl USP equivalent to Lincomycin
(API) per unit …..600mg
Pharmaceutical form of applied Injection
drug
Pharmacotherapeutic Group of Antibiotic (Lincosamide antibacterial)
(API)
Reference to Finished product BP 2013
specifications
Proposed Pack size Not submitted
Proposed unit price Not submitted
The status in reference regulatory Lincomycin SXP manufactured by Southern XP IP Pty
authorities Ltd Australia (TGA Approved)
Summary) Firm has summarized information related to
drug substance.
Name, address of drug substance M/s Xinyu Pharmaceutical Co., Ltd No. 158 Jintai 5th
manufacturer Road Economic development Zone Suzhou Anhui
Province China.
Module-III Drug Substance: Firm has submitted detailed drug substance data for both
sources related to nomenclature, structure, general
Stability Studies of Drug Substance Firm has submitted stability study data of 3 batches of API
(Conditions & duration of Stability (17081041, 17081042, 17081043) conducted at
studies) accelerated conditions 40oC ±2oC / 75% ± 5% RH for 6
months as well as real time conditions. The real time
stability data is conducted at 25oC ± 2oC / 60 ± 5% RH &
30oC ± 2oC / 75 ± 5% RH. The stability study data is for
9 months.
process validation protocols, control of excipients, control
of drug product, specifications, analytical procedures,
Pharmaceutical Equivalence and Pharmaceutical Equivalence with 5 chines manufactured
Comparative Dissolution Profile products is submitted.
Analytical method Firm has submitted analytical method validation studies
validation/verification of product for the applied product.
Container closure system of the Low Borosilicate glass
drug product
Stability study data of drug product, Firm has submitted stability study data of 3 batches
shelf life and storage conditions (W170513, W170422 & W170722). The accelerated
stability study data is conducted at 40oC ±2oC / 75% ± 5%
RH for 6 months. The real time stability study data is
conducted at 30oC ±2oC / 75% ± 5% RH. The real time
stability study data of 3 batches is for 34 months
Evaluation by PEC:
Copy of valid DSL. The firm has submitted the copy of DSL.
Copy of GMP certificate is submitted and The firm has submitted copy of compliance certificate
aforesaid GMP was valid till 08.03.2021. issued by fifth sub office of Anhui Drug Administration
Valid legalized GMP certificate needs to be However valid GMP certificate needs to be submitted.
submitted.
Legalized valid CoPP is required. Copy of CoPP issued by the company is provided. Valid
legalized CoPP issued by the concerned drug authorities
need to be submitted.
Sole agency agreement needs to be Copy of sole agency agreement is submitted.
submitted.
Proposed Price & Pack Size needs to be Not provided.
submitted (1.5.4)
3.2.P. 1. Function of Benzyl alcohol is Firm clarified that its role is as preservative.
mentioned as anesthetic and disinfectant, this
needs to be justified by relevant references.
Further quality standards of the ingredients
are not provided.
3.2. P.3.2 The quantity of API Firm informed that API is calculated as Lincomycin
calculated/ batch does not correspond to the 600mg equivalent to Lincomycin HCl 680.44mg.
label claim and BP monograph. This requires
clarification.
Decision: Deferred for submission of valid legalized CoPP issued by the regulatory authority of
country of origin.
359. Name, address of Applicant / Marketing M/s Shaigan Pharmaceuticals Pvt Limited,
Authorization Holder 14 Km Adyala Road Post Office Dahgal
Rawalpindi.
Name, address of Manufacturing site. M/s Shaigan Pharmaceuticals Pvt Limited,
14 Km Adyala Road Post Office Dahgal
Rawalpindi.
☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand name Admit XR 50/1000 Tablets
Pharmaceutical ingredient (API) per unit Sitagliptin as phosphate
monohydrate…50mg
Metformin HCl (Extended
Release)….1000mg
Reference to Finished product specifications As per Innovators Specifications

The status in reference regulatory authorities Janumet XR of Merck Sharp & Dhome USA
For generic drugs (me-too status) Tagipmet XR of Highnoon Labs Lahore
GMP status of the Finished product GMP certificate was issued to the firm by
manufacturer DRAP Islamabad dated 28.08.2020 based on
inspection dated 25.09.2019
Name and address of API manufacturer. Sitagliptin Phosphate Monohydrate
M/s Changzhou Pharmaceutical Factory,
Address No. 518 Laodong East Road
Changzhou Jiangsu Province, China.
Metformin HCl
M/s Smruthi Organics Limited, Plot No. A-
27, M.I.D.C Chincoli Tal-Mohol Solapur
413255 Maharashtra India
of specification, container closure system
and stability studies of drug substance and
Module III (Drug Substance) Firm has submitted detail of nomenclature,
impurities specifications, analytical
procedures, batch analysis and justification
of specification, reference standard,
container closure system and stability studies
of drug substance
months
3 months
process and controls, specifications,
analytical procedure (including dissolution
testing) and batch analysis and justification
of drug product.
dissolution profile established against the reference product
Janumet XR Tablets
aforesaid brand in three media. The f2 value
Analytical method validation/verification of Method validation studies have been
product submitted.
M/s Changzhou Pharmaceutical Factory, Address No. 518
Laodong East Road Changzhou Jiangsu Province, China.
Metformin HCl
M/s Smruthi Organics Limited, Plot No. A-27, M.I.D.C
Chincoli Tal-Mohol Solapur 413255 Maharashtra India
20200805 Mfg. date: 08.2020 Exp. Date: 07.2022
Metformin HCl
MNET-009/20 Mfg. date: 01.2020 Exp. Date: 12.2024
Description of Pack
Alu- Alu blister packed in unit carton (2x7’s)
Real Time: 0, 3, 6, 9, 12, 24 (Months)
Batch No. T-001 T-002 T-003
No. of Batches 03
1. Reference of previous approval of applications Not provided by the firm
2. Approval of API/ DML/GMP certificate of API Sitagliptin Phosphate Monohydrate
manufacturer issued by concerned regulatory Copy of GMP certificate issued by CFDA
authority of country of origin. which is valid till 12.11.2023.
Metformin HCl
Copy of GMP certificate issued by FDA
Mahaxsrashtra State India which is valid till
13.11.2022.
3. Documents for the procurement of API with Not provided by the firm

chromatograms,
5. Compliance Record of HPLC software 21CFR Not provided
Query Reply
Sitagliptin Firm has submitted the route of synthesis of
Studies for elucidation of structure are not submitted Sitagliptin instead the characterization
Batch size is not provided in stability summary/ data studies.
Evidence of import of API (Sitagliptin Phosphate Firm has submitted the copy of DRAP
Monohydrate & Metformin HCl) used for product attested import invoice of Sitagliptin and
development. metformin.
Propyl Gallate is added in formulation in metformin core Firm has submitted prescribing information
as antioxidant, justification needs to be submitted with of Innovator emphasizing on the description
literature/ innovator product references of products rather addressing the query.
You have mentioned in pharmaceutical development that The firm submitted that Sitagliptin is coated
metformin core tablet is coated with Sitagliptin layer and with soluble polymeric layer carried by film
same is again coated with polymeric layer, but the coating with Opadry green .
formulation and manufacturing method does not reflect
the polymeric layer. This requires justification keeping in
view the reference product.
You have mentioned that 20% (overage) additional The firm informed that 64.25mg of
Sitagliptin is added to the formulation to compensate loss Sitagliptin monohydrate is equal to 50mg of
of Sitagliptin during coating process. This needs to be free base. To compensate process losses vial
justified with experimental data. film coating process Sitagliptin is used in
20% of excess to achieve 100% assay results.
Stability data of three months is provided, additional data Firm has submitted the six months of
needs to be submitted. stability data.

• Regsitration Board decided to advise that firm shall manufacture the product as per
Innovator product composition i.e. Janumet XR wherein propyl gallate has been used in
API cotaing solution of sitagliptin and shall also include test of Propyl gallate assay in drug
product specification for commercial manufacturing.
• Registration Board advised PEC, PE&R Division to present agenda regarding
abovementioned point for further deliberation and issuance of advisory accordingly.
360. Name, address of Applicant / M/s Weather Fold Pharmaceuticals Plot No. 69/1,
Marketing Authorization Holder Phase-II Industrial Estate Hattar.
Name, address of M/s Weather Fold Pharmaceuticals Plot No. 69/1, Phase-
Manufacturing site. II Industrial Estate Hattar.
☐ Importer
Pirfond 801mg Tablet
/ brand name
of Active Pharmaceutical Pirfenidone (EP)….801mg
Film Coated Tablet
drug
Antifibrotic (Idiopathic Pulmonary Fibrosis)
(API)
specifications
Proposed Pack size 1As per SRO

Esbriet Tablets of USFDA
NA
status)
GMP status of the Finished Issuance of GMP certificate was recommended by the
product manufacturer panel vide inspection dated: 02.02.2019.
Name and address of API M/s Optimus Drugs Pvt Limited, Sy. No. 239 & 240
manufacturer. Dothigudem Village Pochampally Mandal Yadari
Bhuvanagiri District 5080284 Telangana India
comparative dissolution profile against the reference product Estbreit
Manufacturer of M/s Optimus Drugs Pvt Limited, Sy. No. 239 & 240 Dothigudem Village Pochampally
API Mandal Yadari Bhuvanagiri District 5080284 Telangana India
API Lot No. OP-PIF-A1-001/20 Mfg. date 28.06.2020 Exp. Date: 26.06.2024
Description of
Pack
(Container
closure system)
Stability
Real time: 30°C ± 2°C / 65% ± 5%RH
Storage
Condition
Real Time: 0, 3, 6, 9, 12, 24 (Months)
Manufacturing 12.2020 12.2020 12.2020

Date
Date of 29.12.2020 29.12.2020
29.12.2020
Initiation
No. of Batches 03
2. Approval of API/ DML/GMP GMP certificate issued by Drugs Control Administration
certificate of API manufacturer Govt. of Telangana India dated 03.03.2020 valid for three
issued by concerned regulatory years from date of issuance
3. Documents for the procurement of The firm submitted copy of DRAP attested invoice No.
API with approval from DRAP (in 2021OD208/EXP dated 17.10.2020 and attestation by
case of import). DRAP Peshawar dated 05.11.2020.

data sheets etc.
☐ Importer
/ brand name
Film Coated Tablet
drug
(API)
specifications

NA
status)
Description of
Pack
(Container
closure system)
Stability
Real time: 30°C ± 2°C / 65% ± 5%RH
Storage
Condition
Real Time: 0, 3, 6, 9, 12, 24 (Months)
Batch No. PD-04 PD-05 PD-06
Manufacturing 12.2020 12.2020 12.2020

Date
Date of 08.12.2020 08.12.2020 08.12.2020
Initiation
No. of Batches 03

data sheets etc.
☐ Importer
/ brand name
Film Coated Tablet
drug
(API)
specifications

NA
status)
Description of
Pack
(Container
closure system)
Stability
Real time: 30°C ± 2°C / 65% ± 5%RH
Storage
Condition
Real Time: 0, 3, 6, 9, 12, 24 (Months)
Manufacturing 12.2020 12.2020 12.2020

Date
Date of 08.12.2020 08.12.2020 08.12.2020
Initiation
No. of Batches 03

data sheets etc.
Case No. 3 Deferred cases in previous meetings

363. Name, address of Applicant / Importer M/s AMB HK Enterprises (Pvt) Ltd., 2nd Floor
Plaza 60 Commercial Block-K, Phase 1 DHA
Lahore
Address: 2nd Floor Plaza 60 Commercial Block-
K, Phase 1 DHA Lahore
Validity: 24.02.2023
Name and address of marketing M/s Reyoung Pharmaceutical Co., Ltd., No. 1
authorization holder (abroad) Ruiyang Road Yiyuan County Shandong Province
P.R. China
Name, address of manufacturer(s) M/s Reyoung Pharmaceutical Co., Ltd., No. 1
Ruiyang Road Yiyuan County Shandong Province
P.R. China
Name of exporting country People’s Republic of China
Detail of certificates attached (CoPP, Free CoPP: Firm has submitted original legalized
sale certificate, GMP certificate) COPP No. 201910002 issued by Yiyuan Market
Supervision Administration of P.R China.
Details of letter of authorization / sole Copy of sole agency agreement is submitted b/w
agency agreement M/s Reyoung Pharmaceutical Co., Ltd., China and
M/s AMB HK Enterprises (Pvt) Ltd. Lahore
☒ Importer
☐ Export sale
purpose only
Details of fee submitted PKR /-: 150000/- dated 02.11.2021
The proposed proprietary name / brand CEFITRIN 1GM INJECTION
name
Pharmaceutical ingredient (API) per unit Ceftriaxone as sodium………1gm
Pharmaceutical form of applied drug Powder for Injection
Pharmacotherapeutic Group of (API) Antibiotic
specifications
Proposed Pack size Pack of 1 Vial and 1ampoule of 10ml
Proposed unit price Rs. 319.50/- per vail
The status in reference regulatory Rocephin 1gm injection
authorities
For generic drugs (me-too status) Rocephin 1gm Injection (Reg No.050585)
Module-II (Quality Overall Summary) Firm has submitted QOS as per Module II.
Name, address of drug substance M/s Reyoung Pharmaceutical Co., Ltd., No. 1
manufacturer Ruiyang Road Yiyuan County Shandong Province
P.R. China
Module-III Drug Substance: Firm has submitted drug substance data for
sources related to nomenclature, structure, general
manufacturers, flow diagram of manufacturing
analytical procedures, batch analysis and
drug substance.
6 months
its description, composition, manufacture,
procedures, method validation studies, batch
and stability.
Pharmaceutical Equivalence and Pharmaceutical equivalence data submitted with
Comparative Dissolution Profile Rocephin 1gm injection.
Container closure system of the drug Type I Glass Vial
product 10ml Type I Glass Ampoule
Stability study data of drug product, shelf Firm has submitted stability study data of 3
life and storage conditions batches. Accelerated stability studies have been
conducted at 40oC±2oC and 75%±5% RH for 6
months.
Firm requested 36months shelf life
st
The above product was considered in 321 meeting of Registration Board and the Board decided as
under:
• Issuance of CoPP by relevant regulatory authority.
• Submission of legalized CoPP as present expired on 23.10.2021 (2 days after submission of
application).
In response the firm vide Dy. No. 31427 dated 02.11.2022 has now submitted the valid legalized CoPP
vide No. Shandong 20223118 issued by Shandong Provincial Medical Products Administration dated
13.09.2022 valid till 12.09.2024.
Decision: Approved as per Policy for inspection of Manufacturer abroad.
Lahore

Name and address of marketing M/s Haikou Pharmaceutical Factory Co., Ltd., No.
authorization holder (abroad) 192 Nanahai Road, Xiuying District Haikou
Hainan, China
Name, address of manufacturer(s) M/s Haikou Pharmaceutical Factory Co., Ltd., No.
192 Nanahai Road, Xiuying District Haikou
Hainan, China.
Detail of certificates attached (CoPP, CoPP: Firm has submitted original legalized
Freesale certificate, GMP certificate) COPP (No. Hainan 20200007) issued on
30.04.2020 by Hainan Medical Products
Administration, People’s Republic of China.
Details of letter of authorization / sole Copy of sole agency agreement is submitted,

agency agreement which indicates agreement of M/s Haikou
Pharmaceutical Factory Co., Ltd., & M/s Jilin
North Biotech Pharma Imp & Exp Co. Ltd China
with M/s AMB HK Enterprises (Pvt) Ltd Lahore
☒ Importer
☐ Export sale
purpose only
Details of fee submitted PKR 100000/- dated 26-04-2021 and 50000/-
dated 07-06-2021
The proposed proprietary name / brand MEROGON INJECTION 1g
name
Pharmaceutical ingredient (API) per unit Meropenem (as Meropenem trihydrate) …….1g
specifications
Proposed Pack size Pack of 1’s Vial
Proposed unit price Rs 2463/- per vial
The status in reference regulatory USFDA Approved.
authorities
For generic drugs (me-too status) MERONEM Injection of Pfizer (reg no. 096203)
Module-II (Quality Overall Summary) Firm has submitted QOS. Firm has summarized
Name, address of drug substance Chongqing Tiandi Pharmaceutical Co., Ltd., No.
manufacturer 1 Shenyang Road, Zhongzhou Avenue
Zhongxian County Chongquing China.
substance.
conducted at 2-80C. The stability study data is till
24 months.
justification of specifications, reference standard
or materials, container closure system and
stability.
Pharmaceutical Equivalence and Pharmaceutical equivalence has been submitted
Comparative Dissolution Profile by the manufacturer.
Container closure system of the drug USP type-I glass
product
life and storage conditions batches The accelerated stability study data is
conducted at 30oC ±2oC / 75% ± 5% RH. The real
time stability study data of 3 batches is for 24
months
Firm has also submitted in-use stability data after
reconstitution with various diluents used for bolus
injection and infusion
The above product was deferred in 321st meeting of Registration board for submission of valid legalized
CoPP as present expired before submission of registration application. In response to the above decision
the firm has submitted Legalized valid CoPP vide No. Hainan 20220062 issued by Hainan Medical
Products Administration China dated 28.07.2022 valid till 01.01.2024.
Lahore

Name and address of marketing M/s Haikou Pharmaceutical Factory Co., Ltd., No.
authorization holder (abroad) 192 Nanahai Road, Xiuying District Haikou
Hainan, China
Name, address of manufacturer(s) M/s Haikou Pharmaceutical Factory Co., Ltd., No.
192 Nanahai Road, Xiuying District Haikou
Hainan, China.
Detail of certificates attached (CoPP, CoPP: Firm has submitted original legalized
Freesale certificate, GMP certificate) COPP (No. Hainan 20200006) issued on
30.04.2020 by Hainan Medical Products
Administration, People’s Republic of China.
Details of letter of authorization / sole Copy of sole agency agreement is submitted,

agency agreement which indicates agreement of M/s Haikou
Pharmaceutical Factory Co., Ltd., & M/s Jilin
North Biotech Pharma Imp & Exp Co. Ltd China
with M/s AMB HK Enterprises (Pvt) Ltd Lahore
☒ Importer
☐ Export sale
purpose only
Details of fee submitted PKR 100000/- dated 26-04-2021 and 50000/-
dated 07-06-2021
The proposed proprietary name / brand MEROGON INJECTION 500mg
name
Pharmaceutical ingredient (API) per unit Meropenem (as Meropenem trihydrate)
…….500mg
specifications
Proposed Pack size Pack of 1’s Vial
Proposed unit price Rs 1289/- per vial
The status in reference regulatory USFDA Approved.
authorities
For generic drugs (me-too status) MERONEM Injection of Pfizer (reg no. 096203)
Module-II (Quality Overall Summary) Firm has submitted QOS. Firm has summarized
Name, address of drug substance Chongqing Tiandi Pharmaceutical Co., Ltd., No.
manufacturer 1 Shenyang Road, Zhongzhou Avenue
Zhongxian County Chongquing China.
substance.
conducted at 2-80C. The stability study data is till
24 months.
stability.
Pharmaceutical Equivalence and Pharmaceutical equivalence is submitted by the
Comparative Dissolution Profile firm
Container closure system of the drug USP type-I glass
product
life and storage conditions batches The accelerated stability study data is
conducted at 30oC ±2oC / 75% ± 5% RH. The real
time stability study data of 3 batches is for 24
months
Firm has also submitted in-use stability data after
reconstitution with various diluents used for bolus
injection and infusion
The above product was deferred in 321st meeting of Registration board for submission of valid legalized
CoPP as present expired before submission of registration application. In response to the above decision
the firm has submitted Legalized valid CoPP vide No. Hainan 20220061 issued by Hainan Medical
Products Administration China dated 28.07.2022 valid till 01.01.2024.
366. Name, address of Applicant / Importer M/s. Glisten Pharma,
Plot No. 520 Sector 7/A Korangi Industrial
Area Karachi.
Details of Drug Sale License of importer License No: 10930 dated 15.04.2019
Address: Plot No. 520 Sector 7/A Korangi
Industrial Area Karachi.
Status: Drug License by way of Whole Sale
Name and address of marketing M/s Pierrel Pharma S.R.L.,
authorization holder (abroad) Strada Statale Appia 46/48-& Bis 46/48
81043Capua Italy
Name, address of manufacturer(s) M/s Pierrel S.p.A Strada Statale Appia 46/48-&
Bis 46/48 81043Capua Italy
Name of exporting country Italy
Detail of certificates attached (CoPP, Free Firm has submitted legalized CoPP Bo. No CPP
sale certificate, GMP certificate) /2019/1312 dated 18.06.2019
Details of letter of authorization / sole The firm has submitted original sole agency
agency agreement agreement dated 11.09.2019 by marketing
authorization holder i.e. M/s Pierrel Pharma
S.R.L., Strada Statale Appia 46/48-& Bis 46/48
81043Capua Italy
☒ Importer
☐ Export sale
purpose only
Details of fee submitted PKR 100,000/- dated 06.01.2021
The proposed proprietary name / brand ORABLOC 1:100,000
name
Strength / concentration of drug of Active Each 1ml solution for injection contains:
Pharmaceutical ingredient (API) per unit Articaine HCl….40mg
Adrenaline (Epinephrine) as tartrate….0.01mg
Pharmaceutical form of applied drug Solution for Injection for dental use
Pharmacotherapeutic Group of (API) Local Anesthetic
Reference to Finished product Ph. Eur.
specifications
Proposed Pack size Rs. 7000/- for 50 Cartridges of 1.8ml
Proposed unit price Price will be communicated at time of pricing.
The status in reference regulatory USFDA approved
authorities
For generic drugs (me-too status) Articaine 4% with Epinephrine 1:100000 of
continental Chemical Company Islamabad.
Reg. No: 052238
Name, address of drug substance ARTICAINE HCL:
manufacturer i. Name of Holder: Moehs Iberica S.L Cesar
MArtinell Brunet No., 12 A Poligono
Industrial rubi Sur Apain 08191 Rubi
Barcelona
Sites of Production: Benechim S.P.R.L
Rue Rene Magritte, 163 Belgium 7860
Lessines
ii. Name of Holder: SIEGFRIED EVIONNAZ
SA, Route du Simplon 1, 36 Switzerlan-1902
Evuibbaz
Sites of Production: SIEGFRIED ST.
VULBAS SAS Parc Industrial de la plaine de
I’Ain France-01150 Saint-Vulbas
Siegfried Evionnaz SA Route du Simplon 1,
36 Switzerlan-1902 Evuibbaz
ADERNALINE TARTRATE:
Name of Holder: CAMBREX PROFARMACO
MILANO S.R.L. Via Curiel, 34 Italy-20067
Paullo, Milano
Site of Production: - CAMBREX
PROFARMACO MILANO S.R.L. Via Curiel, 34
Italy-20067 Paullo, Milano
substance.
conducted at 25oC ± 2oC. The stability study data
is provided till 60 months.
stability.
Pharmaceutical Equivalence and The firm has submitted the Pharmaceutical
Comparative Dissolution Profile equivalence with reference products.
Container closure system of the drug The Primary container consists of a 1.8ml glass
product cartridge made of neutral glass type closed with
bromobutyl rubber plunger and bromobutyl
rubber seal with an aluminium cap.
Stability study data of drug product, shelf Stability testing results of 3 batches of formulation
life and storage conditions are reported at 25oC RH 60% for 24 months, 30oC
/ 65%RH for 12 months and 40oC RH 75% for 6
months. The only impurity detected whose
concentration varies with time and temperature is
Articaine acid (Hydrolysis products of Articaine)
which although reaches maximum concentration
of 0.35% after 6 months at 40oC (stressed
condition) still remains within the set specification
of NMT 0.4% in area with respect to Articaine.
Articaine Acid is the main metabolite of Articaine
and the concentrations found in the drug product,
even at the end of shelf life does not pose any
potential heal concern. The formulation is quite
stable and remains within specifications after 24
months at 25oC, consequently a shelf life storage
condition of 24 months at 25oC is proposed for the
drug product stored in its commercial packaging.
Query Reply
i. Valid Drug Sale License because the i. The firm has submitted new drug sale
submitted copy indicates validity till license issued vide No. 0129 No. DHO
19.02.2022. (East) Drug-786 dated 18.06.2021 valid till
10.06.2023. having address Office No. 403
4th Floor Al Reef Tower, Plot No. 391/3
BYCHS Alamgir Road Karachi. The
address mentioned on the aforesaid new
DSL is different from the address of the
ii. Differential fee of 50,000/- is required w.r.t. DSL submitted initially with the application.
revised fee SRO because registration
application was submitted on 07.10.2021. ii. The firm has now submitted the differential
iii. Proposed Price needs to be submitted being fee of 50000/- vide Slip No. 17375749 dated
requirement of application i.e. Form-5F. 03.08.2022.
iv. Reference of other similar approved
medicines with information pertaining to iii. The firm submitted price of Rs. 7000/- for
Manufacturer name, brand name, strength, 50 Cartridges of 1.8ml.
composition, registration number & dosage
form, Pack size and Price as required under iv. Articaine 4% with Epinephrine 1:100000 of
1.5.8. continental Chemical Company Islamabad.
v. Long term stability study data need to be v. Reg. No: 052238.
submitted as per Zone IV-A i.e.
(30oC/65%RH).
vi. The firm has attached intermediate study of
30oC / 65%RH for 12 months of three
batches which has already been provided.
Evaluation by PEC:
Registration Board in 321st meeting deferred for following and accordingly the reply is tabulated against
each:
Clarification whether the sole agency agreement is The firm has submitted the new agency agreement
with M/s. Glisten Pharma, Plot No. 520 Sector 7/A indicating DSL: M/s Glisten Pharma Office No.
Korangi Industrial Area Karachi or with M/s 403 4th Floor Al Reef Tower, Plot No. 391/3
Glisten Pharma Office No. 403 4th Floor Al Reef BYCHS Alamgir Road Karachi as warehouse of
Tower, Plot No. 391/3 BYCHS Alamgir Road the firm and head office as M/s. Glisten Pharma,
Karachi. Plot No. 520 Sector 7/A Korangi Industrial Area
Karachi
Clarification of the address of DSL since two DSL The firm informed that we have change
with different address have been submitted wareghouse due to safety reasons, hence DSL M/s
Glisten Pharma Office No. 403 4th Floor Al Reef
Tower, Plot No. 391/3 BYCHS Alamgir Road
Karachi will be the ware house of the firm.
Submission of long term stability studies data as per The storage conditions of the product is below
Zone IV a conditions till claimed shelf life. 25C therefore stability studies for the Zone IV A
are not conducted. Intermediate studies at
30C/65% RH have been performed.
Decision: Approved with Innovators specifications as per policy of inspections of manufacturer
abroad with shelf life as per available data of long term stability studies on Zone
IV conditions. The firm shall also submit following before issuance of registration
letter:
i. New agency agreement in name of address as mentioned on the DSL because the earlier
letter indicates DSL address as warehouse.
ii. Full fee as address of Importer is changed as per submitted new DSL.
Item No. IX: Agenda of Evaluator-XX (Mst. Sana Kanwal)

EVALUATION OF REGISTRATION DOSSIERS ON PRIORITY BASIS ON ACCOUNT OF
EXPORT FACILITATION.
In pursuance of decision of 133rd meeting of DRAP Authority held on 13th April 2022, wherein it
was decided to grant registration on priority basis to the pharmaceutical i.e one molecule for each
100,000 USD worth of export of medicines (to a maximum of 15 such molecules) during a fiscal year.
In compliance to the aforementioned decision of the Board, the following firm have achieved the
benchmark of more than 100,000 USD during the fiscal Year 2021-2022 and submitted their
applications for priority consideration/ evaluation as communicated by Assistant Director (PR-I/EFD)
vide letter No No.F.1-6/2019-PR-I (EFD dated 06th October 2022.
367. Name, address of Applicant / Marketing M/s WnsFeild Pharmaceutical
Authorization Holder Industrial Estate Hattar Haripur Kpk Pakistan.
M/s WnsFeild Pharmaceutical
Name, address of Manufacturing site. Plot No. 122 Phase 5, Industrial Estate Hattar
Haripur Kpk Pakistan.
☒ Manufacturer
☐ Importer
Status of the applicant
giver)
☐ New Drug Product (NDP)
Status of application
☐Domestic sale
Intended use of pharmaceutical product ☐ Export sale
Dy. No. and date of submission Dy. No. 23665 DRAP (R&I) dated 22/08/2022
Esonyp 20/375mg DR Tablet
name
Each modified release tablet contains:
Esomeprazole (as magnesium trihydrate) as
IR….……………………………….20mg
Naproxen as enteric coated core
…………………………………….375mg
White to Off White color Naproxen oblong shape
Pharmaceutical form of applied drug enteric coated tablet over film coated
Esomeprazole tablets.
Esomeprazole: Proton Pump Inhibitors
Naproxen: Anti-inflammatory and antirheumatic
products, non-steroids. Propionic acid
derivatives.
Innovator’s
specifications
The status in reference regulatory Vimovo delayed release tablet 20/375mg
authorities USFDA
Glomov 20/375mg tablet by M/s Global
Pharmaceutical (Pakistan) Reg No 109338
GMP inspection conducted on 10/12/2020
Tablet (General & General Antibiotic) section
manufacturer
approved.
Esomeprazole: Metrochem API Private Ltd.
India flat No 302, Bhanu Enclave , Sunder
Name and address of API manufacturer.
Nagar, Erragada, Hyderabad , India.
Naproxen: Divis laboratories Limited India
1-72/23(P)/DIVIS/303, Divi towers, cyber hills,
Gachibowli, Hyderabad-500 032, Telangana,
India
Firm has submitted QOS as per WHO QOS-PD
Module-II (Quality Overall Summary) controls, impurities, specifications, analytical
submitted.
Esomeprazole
form, specifications, analytical procedures and
drug substance
Analytical verification studies not provide by

both DS and FPP manufacturer. CoA of relevant
Module III (Drug Substance) batch of DS to be provided by FPP manufacturer
Naproxen
form, specifications.
CoA from both DS and FPP manufacturer is not

provided
both DS and FPP manufacturer.
Esomeprazole
months
Stability studies months
Batches: (ESM M-089, ESM M-092 and ESM-
M-091.)
Naproxen
Not provided
The firm has submitted detail of manufacturers,
Module-III (Drug Product):
Pharmaceutical Equivalence has not been
performed

that is Glomov 20/375mg tablet Batch No
Pharmaceutical equivalence and
21G111 by Global Pharmaceutical (Pakistan),
Esomeprazole:
In water, Acetate Buffer (pH 4.5) and Phosphate
Buffer (pH 6.8).
Naproxen:
Method verification studies have submitted
Analytical method validation/verification
including linearity, range, accuracy, precision,
of product
specificity.
Manufacturer of API
Metrochem API Private Ltd. India
(Esomeprazole)
API Lot No. (Esomeprazole) Not provided
Manufacturer of API
Divis laboratories Limited India
(Naproxen)
API Lot No. (Naproxen) Not provided
Description of Pack
Strength Esonyp 20/375mg DR Tablet
Batch No. EN-01 EN-02 EN-03
No. of Batches 03
Reference of previous approval of N/A
firm (if any)
Approval of API/ DML/GMP certificate Not provided
Documents for the procurement of API Not provided

import).
Data of stability batches will be supported

chromatograms, Summary data sheet to be provided
sheets etc.
Compliance Record of HPLC software Not provided
testing
Record of Digital data logger for Not provided
accelerated)
Remarks of Evaluator
Sr.# Observation Reply
Approval of Drug Substance/Drug Firm has submitted copy of GMP certificate
Manufacturing License of Metrochem API Private Ltd. India No
(DML)/Good Manufacturing L.Dis.No 4084/A3/2019 dated 20.05.2020
Practice (GMP) certificate of the Valid till three years
Drug Substance / API
manufacturer issued by concerned GMP certificate of Divis laboratories
regulatory authority of country of Limited India No L.Dis.No
origin to be provided (for both 816/DCA/AP/2018 dated 24.07.2018
Esomeprazole and Naproxen) Valid till three years
2. Characterization, Elucidation of As naproxen is officially recognized and
Structure and other Characteristics available in USP hence this section is not
of Naproxen to be provided. required.
Drug substance (APIs) that are described

in an officially recognized pharmacopoeia
it is generally sufficient to provide copies
of the IR spectrum. Same to be provided
by the firm.
3. Detailed analytical procedures for Not complied

the testing of drug substance to be
provided by both Drug Substance Firm has submitted analytical procedure
and Drug Product manufacturer of testing finished product rather than
drug substance moreover only brief assay
methods for both drug substances are
submitted from DS manufacturer.
4. Analytical Method Verification complied
studies including specificity,
accuracy and repeatability (method
precision) performed by the Drug
Product manufacturer for both
compendial as well as non
compendial drug substance(s) to
be provided
5. Provide results of analysis of Not complied
relevant batch(es) of Drug Later on firm has submitted CoA of relevant
Substance performed by Drug batch by Drug Product manufacturer and
Product manufacturer used during Drug Substance manufacturer, also
product development and stability documents regarding procurement of
studies, along with Certificate of relevant batch of Drug Substances.
Analysis (COA) of the same batch
from Drug Substance / API
manufacture.
6. COA of primary / secondary Not complied
reference standard for Naproxen Later on firm has submitted CoA of primary
including source and lot number to / secondary reference standard for
be provided. Naproxen including source and lot number.
7. For testing of Pharmacopeial Drug We have used working standard from Drug
Substance, the use of primary substances manufacturer which is qualified
reference standard is against primary standard.
recommended, justify use of
working standard for
8. Stability data of Naproxen to be Firm has submitted stability data of
provided. naproxen as follows:
Real time: 30°C ± 2°C / 65% ± 5%RH for

60 months
6 months
Batches: (2-M5L003, 2-M5L004 and
2M5L005)
9. Pharmaceutical equivalence to be Not complied

established against
innovator/reference product by Pharmaceutical equivalence to be
comparing the results of all quality established against innovator/reference
parameters of developed product by comparing the results of all
formulation against reference quality parameters while firm has
product submitted comparison of assay only.
Furthermore selection of following

mediums in CDP to be justified
Esomeprazole:
In water, Acetate Buffer (pH 4.5) and
Naproxen:
10. The dissolution of naproxen was
evaluated in two different pH Firm has selected dissolution parameters as
media, pH 1.2 and 6.8 and per USFDA dissolution method database.
dissolution of Esomeprazole has
been performed at pH medium 7.4.
Justify dissolution parameters
adopted by firm.
11. Uniformity of dose and microbial
attributes are not provided in Firm has provided Uniformity of dose and
finished product specification microbial attributes for 3 batches EN-01,
EN-02 and EN-03.
12. Provide summary data sheets for Complied.
all 3 batches. EN-01, EN-02. EN-
03
13. Compliance Record of HPLC We use water HPLC (USA made) with
software 21CFR & audit trail Empower2 software which is not 21CFR
reports on product and Record of compliant.
Digital data logger for temperature
and humidity monitoring of Manual record of temp and humidity control
stability chambers to be provided. maintained in log book will be presented at
the time of inspection.
14. Reference of previous approval of Firm has referred to onsite inspection report
applications with stability study of their product for Wnsodex 60mg and
data of the firm (if any) 30mg DDR capsule (dexlansoprazole) on 1st
September, 2020. Further, the said panel
inspection report was discussed in 297th
Drug Registration Board meeting. The case
was approved and the inspection report
The HPLC software is 21CFR Compliant as
Audit trail on the testing reports is available.
Adequate monitoring and control are
available for stability chamber.
Related manufacturing area, equipment,

personnel and Related manufacturing area,
equipment, personnel and utilities are GMP
compliant.
Decision: Deferred for following observations:
• Valid GMP certificate of Drug Substance manufacturer i.e M/s Divis laboratories
Limited India.
• Details of analytical procedures for the testing of drug substances by both Drug
Substance and Drug Product manufacturer including characterisation for Naproxen.
• Pharmaceutical equivalence to be established against innovator/reference product by
comparing the results of all quality parameters. Furthermore, selection of mediums in
CDP studies hall be justified

Name, address of Manufacturing site. Plot No. 122 Phase 5, Industrial Estate Hattar
☐ Importer
giver)
☐Domestic sale
Dy. No. and date of submission Dy. No. 24965 DRAP (R&I) dated 02/09/2022
Esonyp 20/500mg DR Tablet
name
Each modified release tablet contains:
Esomeprazole (as magnesium trihydrate) as
IR….……………………………….20mg
Naproxen as enteric coated core
…………………………………….500mg
White to Off White color Naproxen oblong shape
Pharmaceutical form of applied drug enteric coated tablet over film coated
Esomeprazole tablets.
Esomeprazole: Proton Pump Inhibitors
Naproxen: Anti-inflammatory and antirheumatic
products, non-steroids. Propionic acid
derivatives.
Innovator’s
specifications
The status in reference regulatory Vimovo delayed release tablet 20/500mg
authorities USFDA
Glomov 20/500mg tablet by M/s Global
Pharmaceutical (Pakistan) Reg No 109338
manufacturer
approved.
Esomeprazole: Metrochem API Private Ltd.
India flat No 302, Bhanu Enclave , Sunder
Nagar, Erragada, Hyderabad , India.
Name and address of API manufacturer. Naproxen: Divis laboratories Limited India
1-72/23(P)/DIVIS/303, Divi towers, cyber hills,
Gachibowli, Hyderabad-500 032, Telangana,
India
Firm has submitted QOS as per WHO QOS-PD
Module-II (Quality Overall Summary) nomenclature, structure, general properties,
submitted.
Esomeprazole
physical form,specifications, analytical
procedures and justification of specification,

both DS and FPP manufacturer. CoA of relevant
Module III (Drug Substance)
batch of DS to be provided by FPP manufacturer
Naproxen
physical form, specifications.
CoA from both DS and FPP manufacturer is not

provided
both DS and FPP manufacturer.
Esomeprazole
months
Stability studies months
Batches: (ESM M-089, ESM M-092 and ESM-
M-091.)
Naproxen
Not provided
The firm has submitted detail of manufacturers,
Pharmaceutical Equivalence has not been
performed

that is Glomov 20/500mg tablet Batch No
21G115 by Global Pharmaceutical (Pakistan),
Esomeprazole:
In water, Acetate Buffer (pH 4.5) and Phosphate
Buffer (pH 6.8).
Naproxen:
of product
specificity.
Manufacturer of API
Metrochem API Private Ltd. India
(Esomeprazole)
API Lot No. (Esomeprazole) Not provided
Manufacturer of API
Divis laboratories Limited India
(Naproxen)
API Lot No. (Naproxen) Not provided
Description of Pack
Strength Esonyp 20/500mg DR Tablet
Batch No. EN-04 EN-05 EN-06
No. of Batches 03
firm (if any)
import).
Data of stability batches will be supported

chromatograms, Inadequate
sheets etc.
Compliance Record of HPLC software Not provided
testing
Record of Digital data logger for Not provided
accelerated)
Sr.# Observations Reply
1. Approval of Drug Substance/Drug Firm has submitted copy of
Manufacturing License (DML)/Good GMP certificate of Metrochem
Manufacturing Practice (GMP) certificate of the API Private Ltd. India No
Drug Substance / API manufacturer issued by L.Dis.No 4084/A3/2019 dated
concerned regulatory authority of country of 20.05.2020
origin to be provided (for both Esomeprazole Valid till three years
and Naproxen)
GMP certificate of Divis
laboratories Limited India
No L.Dis.No
816/DCA/AP/2018 dated
24.07.2018
Valid till three years
2. Characterization, Elucidation of Structure and As naproxen is officially
other Characteristics of Naproxen to be recognized and available in
provided. USP hence this section is not
required.
Drug substance (APIs) that

are described in an officially
recognized pharmacopoeia it
is generally sufficient to
provide copies of the IR
spectrum. Same to be
provided by the firm.
3. Detailed analytical procedures for the testing of Not complied

drug substance to be provided by both Drug
Substance and Drug Product manufacturer Firm has submitted
analytical procedure of
testing finished product
rather than drug substance
moreover only brief assay
methods for both drug
substances are submitted
from DS manufacturer.
4. Analytical Method Verification studies including complied
manufacturer for both compendial as well as non
compendial drug substance(s) to be provided
5. Provide results of analysis of relevant batch(es) Not complied
of Drug Substance performed by Drug Product Later on firm has submitted
manufacturer used during product development CoA of relevant batch by
and stability studies, along with Certificate of Drug Product manufacturer
Analysis (COA) of the same batch from Drug and Drug Substance
Substance / API manufacture. manufacturer, also documents
regarding procurement of
relevant batch of Drug
Substances.
6. COA of primary / secondary reference standard Not complied
for Naproxen including source and lot number to Later on firm has submitted
be provided. CoA of primary / secondary
reference standard for
Naproxen including source
and lot number
7. For testing of Pharmacopeial Drug Substance, We have used working
the use of primary reference standard is standard from Drug
recommended, justify use of working standard substances manufacturer
for Esomeprazole magnesium which is qualified against
primary standard.
8. Stability data of Naproxen to be provided. Firm has submitted stability
data of naproxen as follows:
Real time: 30°C ± 2°C / 65%

± 5%RH for 60 months
Accelerated: 40°C ± 2°C /
Batches: (2-M5L003, 2-
M5L004 and 2M5L005)
9. Pharmaceutical equivalence to be established Not complied
against innovator/reference product by
comparing the results of all quality parameters of Pharmaceutical equivalence
developed formulation against reference product to be established against
innovator/reference product
by comparing the results of
all quality parameters while
firm has submitted
comparison of assay only.
10. Similarity factor f2 has not been calculated and Not complied.
result has not been concluded accordingly Later on firm has submitted
calculation of f2 (similarity
factor).
Furthermore, selection of
following mediums in CDP
to be justified
Esomeprazole:
In water, Acetate Buffer (pH
4.5) and Phosphate Buffer
(pH 6.8).
Naproxen:
10. The dissolution of naproxen was evaluated in
two different pH media, pH 1.2 and 6.8 and Firm has selected dissolution
dissolution of Esomeprazole has been performed parameters as per USFDA
at pH medium 7.4. Justify dissolution parameters dissolution method database.
adopted by firm.
11. Uniformity of dose and microbial attributes are
not provided in finished product specification Firm has provided Uniformity
of dose and microbial
attributes for 3 batches EN-04,
EN-05 and EN-06.
12. Stability data particularly chromatograms , CoA complied.
and raw data sheets (both accelerated and real
time) for batch No EN-06 is not provided for
each time point
13. Compliance Record of HPLC software 21CFR & We use water HPLC (USA
audit trail reports on product and Record of made) with Empower2
Digital data logger for temperature and humidity software which is not 21CFR
monitoring of stability chambers to be provided. compliant.
Manual record of temp and

humidity control maintained
in log book will be presented
at the time of inspection.
14. Reference of previous approval of applications Firm has referred to onsite
with stability study data of the firm (if any) inspection report of their
product for Wnsodex 60mg
and 30mg DDR capsule
(dexlansoprazole) on 1st
September, 2020. Further, the
said panel inspection report
was discussed in 297th Drug
Registration Board meeting.
The case was approved and
the inspection report confirms
following points:
The HPLC software is 21CFR
Compliant as per record
Audit trail on the testing
reports is available.
Adequate monitoring and
control are available for
stability chamber.
Related manufacturing area,

equipment, personnel and
utilities are GMP compliant.
• Valid GMP certificate of Drug Substance manufacturer i.e M/s Divis laboratories
Limited India.
• Details of analytical procedures for the testing of drug substances by both Drug
Substance and Drug Product manufacturer including characterisation for Naproxen.
• Pharmaceutical equivalence to be established against innovator/reference product by
comparing the results of all quality parameters. Furthermore, selection of mediums in
CDP shall be justified
369. M/s WnsFeild Pharmaceutical

Name, address of Applicant / Marketing
Industrial Estate Hattar Haripur Kpk
Pakistan.
Name, address of Manufacturing site. Plot No. 122 Phase 5, Industrial Estate
Hattar Haripur Kpk Pakistan.
☒ Manufacturer
☐ Importer
(contract giver)
☒ Domestic sale
Dy. No. 4446 (R&I) DRAP, dated
Dy. No. and date of submission
16/02/2022
Verozen 10mg Tablet
name
Vonoprazan (as Fumarate)…….10mg
Light yellow color round, Biconvex Film

coated tablet.
Potassium-Competitive Acid Blokers
(PCAB)
Innovator’s specification
specifications
Takecab 10mg tablet by M/s Takeda
pharmaceutical company Ltd. PMDA
authorities
Japan approved
Vonseca 20mg tablet by M/s Tabros,
Karachi ,Reg No. 112584
Tablet (General & General Antibiotic)
manufacturer
section approved.
Xianqiang Pharmaceutical Pvt Ltd, No. 6,
industrial Avenue, Conghua, Economical
Development zone, Guangzhou city,
Guangdong province, China
Firm has submitted QOS as per WHO
Module-II (Quality Overall Summary)
Official monograph of Vonoprazan is not
present in BP and USP. The firm as
Module III (Drug Substance) manufacturing process and controls, tests
for impurity & related substances,
specifications, batch analysis and
substance
24 months
Stability studies
for 6 months
Batches:(TAK09R150701,
TAK09R150702,
TAK09R150703)
The firm has submitted detail of
acidic and buffer medium) and its
product.
brand that is Voniza 10mg tablet by Hilton
Pharma (Batch No 138849) in Acid media
(pH 1.0-1.2) in Acetate Buffer (pH 4.5) &
Phosphate Buffer (pH 6.8). The values for
including linearity, range, accuracy,
of product

Manufacturer of API Xianqiang Pharmaceutical Pvt Ltd, China
API Lot No.
Description of Pack
system)
Strength 20mg/Tablet
Batch No. VP-01 VP-02 VP-03
No. of Batches 03
firm (if any)
Approval of API/ DML/GMP certificate Firm has submitted copy of GMP
of API manufacturer issued by concerned certificate No. GD20150397 of M/s
regulatory authority of country of origin. Xianqiang Pharmaceutical Pvt Ltd, China
issued by China Food and Drug
Administration. The certificate is valid till
06-09-2020.
Documents for the procurement of API Firm has submitted import License No.
with approval from DRAP (in case of 00169/2021-DRAP CPS/650 dated 16-02-
import). 2021 confirming import of 200g
Vonoprazan from M/s Xianqiang
Pharmaceutical Pvt Ltd, China for Batch
No. TAK09R210101
Data of stability batches will be supported Submitted
chromatograms,
sheets etc.
Compliance Record of HPLC software Not submitted

testing
Record of Digital data logger for Not submitted
accelerated)
Sr. Observation Reply (dated
# 30/10/2022)
Valid Good Manufacturing Practice (GMP) Not complied
certificate of the Drug Substance / API Later on firm has submitted copies
manufacturer issued by concerned of Drug manufacturing certificate
regulatory authority of country of origin to No Yue20160016 dated
be provided 24.12.2020 valid till 23.12.2025
issued by Guandong provincial
Drug Administration and GMP
certificate (No 20220616) dated
16.06.2022 valid till 15.06.2026
Detailed analytical procedures for the complied
testing of drug substance to be provided by
both Drug Substance and Drug Product
manufacturer
Analytical Method Verification studies complied
compendial as well as non compendial
drug substance(s) to be provided
COA of primary / secondary reference Working standard for Vonoprazan
standard for Vonoprazan Fumarate Fumarate batch No A061-210101
including source and lot number to be from Xianqiang Pharmaceutical
provided. Pvt Ltd, China is provided
Pharmaceutical equivalence to be Not complied
established against innovator/reference
product by comparing the results of all Pharmaceutical equivalence to
quality parameters of developed be established against
formulation against reference product innovator/reference product by
comparing the results of all
quality parameters while firm
has submitted comparison of
assay only.
Uniformity of dose and microbial attributes complied
are not provided in finished product
specification
Stability data particularly chromatograms , complied
CoA and raw data sheets (both accelerated
and real time) is not provided for each time
point
Compliance Record of HPLC software We use water HPLC (USA
21CFR & audit trail reports on product and made) with Empower2 software
Record of Digital data logger for which is not 21CFR compliant.
stability chambers to be Manual record of temp and
humidity control maintained in
log book will be presented at the
time of inspection.
Reference of previous approval of Firm has referred to onsite
applications with stability study data of the inspection report of their product
firm (if any) for Wnsodex 60mg and 30mg
DDR capsule (dexlansoprazole)
on 1st September, 2020. Further,
the said panel inspection report
Registration Board meeting. The
case was approved and the
inspection report confirms
following points:
Compliant as per record available
with the firm.
Audit trail on the testing reports is
available.
Adequate monitoring and control
are available for stability chamber.

equipment, personnel and utilities
are GMP compliant.
Justification to be provided for selection of Dissolution parameters are
dissolution parameters i.e Acceptance selected as per USFDA guidance
criteria and volume of dissolution medium document for immediate release
solid dosage form
Compatibility of the Drug Substance(s) Not complied
with excipients is not provided (mainly Later on firm submitted that they
IPA which has been used by the firm in are using purified water in
film coating). Specifications of IPA also coating, IPA was written
not provided. mistakenly.
Decision: Approved with Innovator’s specifications. Registration letter will b eissued
upon submission of Pharmaceutical equivalence studies including all test of batch release
against the innovator/reference comparator product.
studies throughout proposed shelf life and on accelerated studies for six months as
per the commitment submitted in the registration application.
370. M/s WnsFeild Pharmaceutical

Industrial Estate Hattar Haripur Kpk
Pakistan.
Name, address of Manufacturing site. M/s WnsFeild Pharmaceutical
Plot No. 122 Phase 5, Industrial Estate
Hattar Haripur Kpk Pakistan.
☒ Manufacturer
☐ Importer
(contract giver)
☒ Domestic sale
16/02/2022
Verozen 20mg Tablet
name
Active Pharmaceutical ingredient (API) Vonoprazan (as Fumarate)…….20mg
per unit
Light yellow color round, Biconvex Film
coated tablet.
Potassium-Competitive Acid Blokers
(PCAB)
specifications
Takecab 20mg tablet by M/s Takeda
pharmaceutical company Ltd. PMDA
authorities
Japan approved
Vonseca 20mg tablet by M/s Tabros,
Karachi ,Reg No. 112585
GMP inspection conducted on
GMP status of the Finished product 10/12/2020
manufacturer Tablet (General & General Antibiotic)
section approved.
Xianqiang Pharmaceutical Pvt Ltd, No. 6,
industrial Avenue, Conghua, Economical
Official monograph of Vonoprazan is not
present in BP and USP. The firm as
submitted detail of nomenclature,
Module III (Drug Substance) of manufacturing process and controls,
specifications, batch analysis and
drug substance
Real time: 30°C ± 2°C / 65% ± 5%RH
for 24 months
Stability studies
for 6 months
Batches:(TAK09R150701,
TAK09R150702,
TAK09R150703)
procedure (including dissolution testing
at acidic and buffer medium) and its
drug product.
same brand that is Voniza 20mg tablet by
Hilton Pharma (Batch No 138864) in
Acid media (pH 1.0-1.2) in Acetate
Buffer (pH 4.5) & Phosphate Buffer (pH
acceptable range.
Method verification studies have
Analytical method
submitted including linearity, range,
accuracy, precision, specificity.

Manufacturer of API Xianqiang Pharmaceutical Pvt Ltd, China
API Lot No.
Strength 20mg/Tablet
Batch No. VP-04 VP-05 VP-06
No. of Batches 03
Reference of previous approval of The firm has not submitted any document.
the firm (if any)
of API manufacturer issued by certificate No. GD20150397 of M/s
concerned regulatory authority of Xianqiang Pharmaceutical Pvt Ltd, China
country of origin. issued by China Food and Drug
06-09-2020.
with approval from DRAP (in case of 00169/2021-DRAP CPS/650 dated 16-02-
import). 2021 confirming import of 200g
vonoprazan from M/s Xianqiang
Pharmaceutical Pvt Ltd, China for Batch
No. TAK09R210101
sheets etc.
testing
accelerated)
Sr.# Observation Reply (dated
30/10/2022)
Valid Good Manufacturing Practice (GMP) Not complied
certificate of the Drug Substance / API
manufacturer issued by concerned Later on firm has submitted copies
regulatory authority of country of origin to of Drug manufacturing certificate
be provided No Yue20160016 dated
24.12.2020 valid till 23.12.2025
issued by Guandong provincial
Drug Administration and GMP
certificate (No 20220616) dated
16.06.2022 valid till 15.06.2026
Detailed analytical procedures for the complied
manufacturer
Analytical Method Verification studies complied
compendial as well as non compendial
drug substance(s) to be provided
COA of primary / secondary reference Working standard for Vonoprazan
standard for Vonoprazan Fumarate Fumarate batch No A061-210101
including source and lot number to be from Xianqiang Pharmaceutical
provided. Pvt Ltd, China is provided
Pharmaceutical equivalence to be Not complied
established against innovator/reference
product by comparing the results of all Pharmaceutical equivalence to
quality parameters of developed be established against
formulation against reference product innovator/reference product by
comparing the results of all
quality parameters while firm
has submitted comparison of
assay only.
Uniformity of dose and microbial attributes complied
are not provided in finished product
specification
Stability data particularly chromatograms , complied
point
Compliance Record of HPLC software We use water HPLC (USA made)
21CFR & audit trail reports on product and with Empower2 software which is
Record of Digital data logger for not 21CFR compliant.
stability chambers to be Manual record of temp and
humidity control maintained in log
book will be presented at the time
of inspection.
applications with stability study data of the inspection report of their product
firm (if any) for Wnsodex 60mg and 30mg
DDR capsule (dexlansoprazole)
on 1st September, 2020. Further,
the said panel inspection report
Registration Board meeting. The
case was approved and the
inspection report confirms
following points:
with the firm.
available.
Adequate monitoring and control
are available for stability chamber.

are GMP compliant.
Justification to be provided for selection of Dissolution parameters are
dissolution parameters i.e Acceptance selected as per USFDA guidance
criteria and volume of dissolution medium document for immediate release
solid dosage form
Compatibility of the Drug Substance(s) Not complied
with excipients is not provided (mainly
IPA which has been used by the firm in
film coating). Specifications of IPA also
not provided.
Decision: Approved with Innovator’s specifications. Registration letter will b eissued
upon submission of Pharmaceutical equivalence studies including all test of batch release
against the innovator/reference comparator product.

Name, address of Manufacturing site. M/s WnsFeild Pharmaceutical
Plot No. 122 Phase 5, Industrial Estate Hattar
☐ Importer
giver)
☐ Export sale
Venospa 10/100mg Tablet
name
Pharmaceutical ingredient (API) per unit Vonoprazan as Fumarate (outer immediate
release layer)………………...…10mg
Aspirin (as enteric coated inner core)
……………………………..…..100mg
Pharmaceutical form of applied drug White to off-white color Aspirin round shape
enteric coated tablet surrounded by film coated
Vonoprazan tablets.
Pharmacotherapeutic Group of (API) Vonoprazan: Potassium-Competitive Acid
Blocker
Aspirin: Antithrombotic Agents
specifications
The status in reference regulatory Cabpirin 10/100mg tablet by M/s Takeda
authorities Pharmaceutical (Japan)
GMP status of the Finished product GMP inspection conducted on 10/12/2020
approved.
Name and address of API manufacturer. Vonoprazan:
Guangdong Xianqiang Pharmaceutical Pvt Ltd,
No. 6, industrial Avenue, Conghua, Economical
Aspirin
JQC (HUAYIN) Pharmaceutical Co, Ltd/
Yuquan Road, Huayin city, Shanxi province,
P.R of China
submitted
Module III (Drug Substance) Vonoprazan and Aspirin:
drug substance
Stability studies Vonoprazan:
months
months
Batches: TAK09R150701, TAK09R150702,
TAK09R150703
Aspirin:
months
months
Batches: A201104081, A201104082
A201104083

Pharmaceutical equivalence and Pharmaceutical Equivalence not performed.
comparative dissolution profile CDP has been performed against Cabpirin
10/100mg tablet by Takeda Pharma (Japan), in
Acid media (pH 1.0-1.2) acetate buffer (Ph 4.5)
& Phosphate Buffer (pH 6.8). The values for f1
Release profile of aspirin has not been

compared.
specificity.
Manufacturer of API Guangdong Xianqiang Pharmaceutical China (vonoprazan)
JQC (HUAYIN) Pharmaceutical Co, Ltd China (aspirin)
API Lot No. TAK09210101(vonoprazan)
A2012041 (aspirin)
Description of Pack
system)
Strength 10/100mg Tablet
Batch No. VA-01 VA-02 VA-03
No. of Batches 03
firm (if any)
Documents for the procurement of API Vonoprazan:

with approval from DRAP (in case of Firm has submitted import License No.
import). 00169/2021-DRAP CPS/650 dated 16-02-2021
confirming import of 200g VONOPRAZAN
from M/s Guangdong Xianqiang Pharmaceutical
Pvt Ltd, China for Batch No. TAK09R210101
Aspirin:
Firm has submitted import License No.
00138/2021-DRAP 1PS/650 dated 10-02-2021
confirming import of 2Kg ASPIRIN from M/s
JQC (HUAYIN) Pharmaceutical Co, Ltd China
for Batch No. A2012041
Data of stability batches will be supported Inadequate
chromatograms,
sheets etc.
testing
accelerated)

30.10.2022)
Valid Good Manufacturing Practice (GMP) Firm has submitted GMP
certificate of the Drug Substance / API certificate of M/s Guangdong
manufacturer issued by concerned regulatory Xianqiang Pharmaceutical Pvt Ltd,
authority of country of origin to be provided China (GD20150397) issued by
China Food and Drug
Administration valid till 06.09.2020
GMP certificate of M/s JQC
(HUAYIN) Pharmaceutical Co,
Ltd is not submitted
Later on firm has submitted copies

of Drug manufacturing certificate of
M/s Guangdong Xianqiang
Pharmaceutical Pvt Ltd, China No
Yue20160016 dated 24.12.2020
valid till 23.12.2025 issued by
Guandong provincial Drug
Administration and GMP certificate
(No 20220616) dated 16.06.2022
Detailed analytical procedures for the testing Complied

of drug substance Aspirin to be provided by
manufacturer
Provide results of analysis of relevant Complied
batch(es) of Drug Substance Aspirin
performed by Drug Product manufacturer
used during product development and stability
studies, along with Certificate of Analysis
(COA) of the same batch from Drug
Substance / API manufacture
Analytical Method Verification studies
including specificity, accuracy and Not complied
repeatability (method precision) performed by
the Drug Product manufacturer for both Analytical method verification
compendial as well as non compendial drug studies submitted for vonoprazan
substance(s) to be provided fumarate only.
COA of primary / secondary reference
standard for Vonoprazan Fumarate and Not complied
Aspirin including source and lot number to be Later on firm has provided Working
provided standard for Vonoprazan Fumarate
batch No A061-210101 from
Xianqiang Pharmaceutical Pvt Ltd.
However reference standard is not
required for Aspirin since it is
analyzed by titrimetric method.
Dissolution medium used in USFDA To avoid dissolution of enteric
approved formulation VOQUEZNA for coated core of aspirin 0.1NHCl is
evaluation of release profile of vonoprazan used to affect only vonoprazan in
tablet was 0.05M acetate buffer (pH 4.5) with film coating and further to check
50rpm while dissolution medium used by the the enteric coating. 75rpm is
firm is 0.1NHCl and 75 rpm. .Justification to selected as per general guideline of
be provided for selection of dissolution dissolution given in BP 2022 and
medium and rpm for USP type II apparatus. USP.
Not justified since release profile

of aspirin has been monitored
separately by using acid stage
(0.1N HCl) and buffer stage
(phosphate buffer) dissolution.
Pharmaceutical equivalence to be established Not complied
against innovator/reference product by Pharmaceutical equivalence to be
comparing the results of all quality established against
parameters of developed formulation against innovator/reference product by
reference product comparing the results of all
quality parameters while firm has
submitted comparison of assay
only.
CDP for Aspirin has not been performed. CDP for Aspirin has been provided
Moreover, batch no of innovator product has as per following details:
not been mentioned in CDP of Vonoprazan Reference
Product of
Feature product
M/s
(Takeda
Wnsfeild
pharma)
Cabiprin Venospa
Brand
10/100mg 10/100mg
name
tablet tablet
Batch
521559 19PD-219
No.
Comparative dissolution studies
have been performed in following
mediums:
1. pH 4.5 Acetate buffer
2. pH 6.8 Phosphate buffer
The values for f1 and f2 are in the
acceptable range.
CDP of aspirin has not been

assessed in acid medium (Ph 1.2)
Hardness, LOD and microbial attributes are Hardness, LOD and microbial
not provided in finished product specification. attributes are missed from finished
product specification due to
typographic error, now the firm has
submitted results of aforementioned
quality parameters.
Stability data particularly chromatograms , Complied
point (particularly 6th month for all 3 batches)
There is a tendency for loss on drying to Not complied
increase and hardness to decrease under high Later on firm has provided LOD and
temperature and high humidity hence LOD hardness test as per innovator
and hardness test results to be submitted, product.
performed during stability studies
Compliance Record of HPLC software We use water HPLC (USA made)
21CFR & audit trail reports on product and with Empower2 software which is
Record of Digital data logger for temperature not 21CFR compliant.
chambers to be Manual record of temp and humidity
control maintained in log book will
be presented at the time of
inspection.
applications with stability study data of the inspection report of their product for
firm (if any) Wnsodex 60mg and 30mg DDR
capsule (dexlansoprazole) on 1st
September, 2020. Further, the said
panel inspection report was
discussed in 297th Drug Registration
Board meeting. The case was
approved and the inspection report
with the firm.
available.
available for stability chamber.

are GMP compliant.
• Pharmaceutical equivalence studies against the innovator/reference product by
comparing the results of all quality parameters.
• Justification for selection of dissolution mediums in CDP studies, since CDP of Aspirin
has not been performd in acidic medium of pH 1.2
• Justification for selection of dissolution medium for batch release test since already
submitted justification of applying 0.1N HCl dissolutuion medium is not satisfactory.
• Complete method of analysis for dissolution test.
• Clarification of the formulation of innovator product, whetehr it is bilayer by way of
compression or by way of active coating of Vonoprazan.
• Justification of the variation in chromatographic conditions mentioned in drug product
analytical method and those reflected in the submitted HPLC chromatograms.
• Compliance Record of HPLC software 21CFR & audit trail reports on product and
Record of Digital data logger for temperature and humidity monitoring of stability
chambers.
In pursuance of decision of 133rd meeting of DRAP Authority held on 13th April 2022, wherein it was
decided to grant registration on priority basis to the pharmaceutical i.e one molecule for each 100,000
USD worth of export of medicines (to a maximum of 15 such molecules) during a fiscal year.
Registration applications of drugs for which stability study data is submitted for exemption from
onsite verification of stability data
372. Name and address of M/s The Searle Company Limited
manufacturer / Applicant F-319, S.I.T.E., Karachi, Pakistan.
Brand Name +Dosage Form + Jarlina Tablets 10mg+5mg
Strength
Diary No. Date of R& I & fee Dy No. 777 (PEC DRAP) Dated 11.01.19
Rs: 50,000/- 10-12-2018
Empagliflozin…….10mg
Linagliptin….5mg
Finished Product Specification Manufacturer Specs.
Pack size & Demanded Price As per country requirement
Approval status of product in USFDA Approved
Reference Regulatory Authorities. Glyxambi
Me-too status Linjardy 25/5mg tablet (Reg No 112052) by M/s
CCl Lab, Lahore
GMP status GMP inspection conduced on 07/07/2022
approved dated 29.10.2022
Drug Jarlina Tablets 10mg+5mg
Name of Manufacturer M/s The Searle Company Limited F-319, S.I.T.E., Karachi, Pakistan.
Empagliflozin Linagliptin
Anhui Ruyuan HEC Pharm Co., Ltd, CHINA

Youcare
Manufacturer of API kaiyue
Pharmaceutica
l Co.Ltd,
CHINA
Empagliflozin
API Lot No. Linagliptin S204A-RD201712201
20181001002
Description of Pack
(Container closure system) Alu-Alu blister packed in unit carton
Real time : 30°C ± 2°C / 75% ± 5%RH
Stability Storage Condition
Real time: 6 months
Time Period
Real time: 0,3,6 (months)
Frequency
Accelerated: 0,3,6,9,12,18(months)
Batch No. 19PD-219 19PD-220 19PD-221
Batch Size 2500 Tablets 2500 Tablets 2500 Tablet
No. of Batches 03
Date of Submission 22-09-2021 (Dy No. 2604 PEC, DRAP)
DOCUMENTS / DATA PROVIDED BY THE APPLICANT FOR EXEMPTION
S. No. Documents To Be Status
Provided
Reference of previous Firm has referred to onsite inspection report of their
approval of applications product for Tapendol (Tapentadol) Tablets 75mg &
with stability study data 100mg on 11th March, 2019. Further, the said panel
of the firm inspection report was discussed in 289th Drug
Registration Board meeting held on 14th – 16th May
2019. The case was approved and the inspection
report confirms following points:
1. The HPLC software is 21CFR Compliant as per
monitored through software.
Related manufacturing area, equipment, personnel
Certificate of Analysis of Empagliflozin:
API from both API Firm has submitted COA of Empagliflozin (Batch #
Manufacturer and 20181001002) from M/s Anhui Youcare Kaiyue
Finished Product Pharmaceutical Co. Ltd., China. COA (Batch #
manufacturer. 20181001002) from M/s The Searle Company
Limited is also submitted.
2.
Linagliptin:
Firm has submitted COA of Linagliptin (Batch #
S204A-RD201712201) from Ruyuan HEC Pharma
Co. Ltd., China. Copy of COA (Batch # S204A-
RD201712201) from M/s The Searle Company
Limited is also submitted.
Method used for analysis
of API from both API
3. Submitted
Manufacturer & Finished
Stability study data of Empagliflozin:
API from API The firm has submitted copy of accelerated, 06
manufacturer Months (40°C ± 2°C & 75±5%RH) & long term, 36
Months (30°C ± 2°C & 65±5%RH) stability study
reports of 03 batches
4.
Linagliptin:
The firm has submitted copy of accelerated, 06
Months (40°C ± 2°C & 75±5%RH) & long term, 36
Months (30°C ± 2°C & 65±5%RH) stability study
reports of 03 batches
Approval of API/ Empagliflozin:
DML/GMP certificate of Firm has submitted copy of GMP certificate by M/s
API manufacturer issued Anhui Youcare Kaiyue Pharmaceutical Co. Ltd.,
5.
by concerned regulatory China issued by Anhui Food and Drug
authority of country of Administration of the People’s Republic of China.
origin. The certificate is valid till 05-03-2023.
Linagliptin:
Firm has submitted copy of GMP certificate of
Ruyuan HEC Pharma Co. Ltd., China issued by
Shaoguan Food and Drug Administration, China. The
certificate is valid till 06-01-2024..
Documents for the Firm has submitted import License No. 0010/19-
procurement of API with DRAP dated 01-01-2019 confirming import of 1Kg
approval from DRAP (in Empagliflozin from M/s Anhui Youcare Kaiyue
case of import). Pharmaceutical Co. Ltd., China for Batch #
6. 20181001002.
Firm has submitted import License No. 0546/18-
DRAP dated 14-02-2018 confirming import of 0.5Kg
Linagliptin from M/s Ruyuan HEC Pharma Co. Ltd.,
China for Batch # S204A-RD201712201
Protocols followed for
7. conduction of stability Submitted
study
Method used for analysis Submitted
8.
of FPP
Drug-excipients Firm has submitted that same excipients has been
compatibility studies used as used by innovator ‘GLYXAMBI Tablets
9. (where applicable) 25mg + 5mg’. However, there is only difference in
film coating materials Therefore, Drug-excipients
compatibility studies were not performed.
Complete batch The firm has manufactured three stability batches of
manufacturing record of Empagliflozin + Linagliptin Tablets 25mg + 5mg and
three stability batches. has submitted copy of complete batch manufacturing.
Jarlina Tablets 10mg+5mg
Batch No. Bach size Mfg. Date
10.
October
19PD-219 2500 Tablets
2019
October
2019
October
2019
Record of comparative Firm has submitted Comparative dissolution study of
dissolution data their product with Innovator’s Brand “GLYXAMBI”.
(where applicable) The details are as follows:
Product of
Feature Reference
M/s The Searle
product
Company
GLYXAMBI
Brand Jarlina Tablets
Tablets 10mg
11. name 10mg+5mg
+ 5mg
Batch No. 803783A 19PD-219
Comparative dissolution studies have been performed
in following mediums:
1. pH 1.2 HCl buffer
The Average % release of both Drug substances in all
three mediums is more than 85% at 15 minutes hence
there is no need to calculate f2 value. The CDP of
Jarlina Tablets 10mg+5mg against GLYXAMBI
Tablets 10mg + 5mg shows equivalence.
Data of 03 batches will
be supported by attested
respective documents
12. Submitted
like chromatograms,
Raw data sheets, COA,
Compliance Record of Submitted
HPLC software 21CFR
13.
product testing.
Record of Digital data Firm has submitted record of digital data logger for
logger for temperature temperature and humidity monitoring of stability
and humidity monitoring chambers.
14.
of stability chambers
(real time and
accelerated)
Sr Observations Firm’s response (dated 25th October,

No. 2022)
1 Analytical Method Validation Detailed analytical testing method along with
studies to be submitted by the firm. validation studies are submitted including
validation parameters such as accuracy,
precision, system suitability, range, robustness
and specificity
2 Justification shall be provided for
selection of acceptance criteria of At initial stage firm adopted specification from
dissolution i.e NLT 80% (75% Q BP General chapter “Appendix XII B. Annex X:
value) after 45 minutes while Recommendation on dissolution testing” which
USFDA guidance document on states that “at least 80% of active substance is
Dissolution Testing and released within a specified time, typically 45min
Acceptance Criteria for Immediate- or less (75% Q value). However dissolution
Release Solid Oral Dosage Form specification was revised on 29 Jan 2020 before
Drug Products Containing High the testing of 3rd month stability interval from
Solubility Drug Substances 45 min to 30min as per CDER report of USFDA
recommends dissolution criterion approved reference product Glyxambi (NDA
as Q=80% in 30 minutes 206-073).
Decision: Approved with innovators specifications. The firm shall submit fee of Rs. 7500/- for
373. Name and address of manufacturer / M/s The Searle Company Limited
Applicant F-319, S.I.T.E., Karachi, Pakistan.
Brand Name +Dosage Form + Strength Jarlina Tablets 25mg+5mg
Diary No. Date of R& I & fee Dy No. 776 dated 11.01.2019 , Rs:
50,000/- 10-12-2018
Empagliflozin…….25mg
Linagliptin….5mg
Pharmacological Group Anti diabetic
Pack size & Demanded Price As per country requirement
Approval status of product in Reference USFDA Approved
Regulatory Authorities. Glyxambi
Me-too status Linjardy 25/5mg tablet (Reg No 112052)
by M/s CCl Lab, Lahore
GMP status GMP inspection conduced on 07/07/2022
Tablet (General & General Antibiotic)
section approved dated 29.10.2022
Drug Jarlina Tablets 25mg+5mg
Empagliflozin: Linagliptin
Anhui Youcare Ruyuan HEC Pharm Co., Ltd, CHINA

Manufacturer of API kaiyue
Pharmaceutical
Co.Ltd, CHINA
Empagliflozin
API Lot No. Linagliptin S204A-RD201712201
20181001002
Description of Pack
Real time : 30°C ± 2°C / 75% ± 5%RH
Real time: 6 months
Time Period
Frequency
Batch No. 19PD-202 19PD-212 19PD-211
No. of Batches 03
S. Documents To Be Provided Status
No.
Reference of previous approval of Firm has referred to onsite inspection report of
applications with stability study data of the their product for Tapendol (Tapentadol)
firm Tablets 75mg & 100mg on 11th March, 2019.
Further, the said panel inspection report was
discussed in 289th Drug Registration Board
meeting held on 14th – 16th May 2019. The
1.
for stability chamber. Chambers are controlled
and monitored through software.
Certificate of Analysis of API from both Empagliflozin:
API Manufacturer and Finished Product Firm has submitted COA of Empagliflozin
manufacturer. (Batch # 20181001002) from M/s Anhui
Youcare Kaiyue Pharmaceutical Co. Ltd.,
China. COA (Batch # 20181001002) from M/s
The Searle Company Limited is also
2. submitted.
Linagliptin:
Firm has submitted COA of Linagliptin (Batch
# S204A-RD201712201) from Ruyuan HEC
Pharma Co. Ltd., China. Copy of COA (Batch
# S204A-RD201712201) from M/s The Searle
Company Limited is also submitted.
Method used for analysis of API from both
3. API Manufacturer & Finished Product Submitted
manufacturer
Stability study data of API from API Empagliflozin:
manufacturer The firm has submitted copy of accelerated, 06
Months (40°C ± 2°C & 75±5%RH) & long
term, 36 Months (30°C ± 2°C & 65±5%RH)
4.
Linagliptin:
The firm has submitted copy of accelerated, 06
Months (40°C ± 2°C & 75±5%RH) & long
term, 36 Months (30°C ± 2°C & 65±5%RH)
Approval of API/ DML/GMP certificate of Empagliflozin:
API manufacturer issued by concerned Firm has submitted copy of GMP certificate by
regulatory authority of country of origin. M/s Anhui Youcare Kaiyue Pharmaceutical
Co. Ltd., China issued by Anhui Food and
Drug Administration of the People’s Republic
of China. The certificate is valid till 05-03-
5.
2023.
Linagliptin:
Firm has submitted copy of GMP certificate of
Ruyuan HEC Pharma Co. Ltd., China issued
by Shaoguan Food and Drug Administration,
China. The certificate is valid till 06-01-2024.
with approval from DRAP (in case of 0010/19-DRAP dated 01-01-2019 confirming
import). import of 1Kg Empagliflozin from M/s Anhui
Youcare Kaiyue Pharmaceutical Co. Ltd.,
China for Batch # 20181001002.
6.
Firm has submitted import License No.
0546/18-DRAP dated 14-02-2018 confirming
import of 0.5Kg Linagliptin from M/s Ruyuan
HEC Pharma Co. Ltd., China for Batch #
S204A-RD201712201
Protocols followed for conduction of
7. Submitted
stability study
Drug-excipients compatibility studies Firm has submitted that same excipients has
(where applicable) been used as used by innovator ‘GLYXAMBI
Tablets 25mg + 5mg’. However, there is only
9.
difference in film coating materials Therefore,
Drug-excipients compatibility studies were not
performed.
Complete batch manufacturing record of The firm has manufactured three stability
three stability batches. batches of Empagliflozin + Linagliptin Tablets
25mg + 5mg and has submitted copy of
complete batch manufacturing. Details are as
under:
Jarlina Tablets 25mg+5mg
10. Batch No. Bach size Mfg. Date
September
2019
September
2019
September
2019
Record of comparative dissolution data Firm has submitted Comparative dissolution
(where applicable) study of their product with Innovator’s Brand
“GLYXAMBI”. The details are as follows:
Product of
Feature Reference M/s The
product Searle
Company
GLYXAMBI
Brand Jarlina Tablets
Tablets 25mg
name 25mg+5mg
+ 5mg
11. Batch No. 803794A 19PD-202
Comparative dissolution studies have been
performed in following mediums:
The Average % release of both Drug

substances in all three mediums is more than
85% at 15 minutes hence there is no need to
calculate f2 value. The CDP of Jarlina Tablets
25mg+5mg against GLYXAMBI Tablets 25mg
+ 5mg shows equivalence.
Data of 03 batches will be supported by

12. Submitted
Compliance Record of HPLC software Submitted
13. 21CFR & audit trail reports on product
testing.
Record of Digital data logger for Firm has submitted record of digital data
14.
stability chambers (real time and monitoring of stability chambers.
accelerated)
Sr Observations Firm’s response (dated 25th October,
No. 2022)
1 Analytical Method Validation Detailed analytical testing method along with
studies to be submitted by the firm. validation studies are submitted including
validation parameters such as accuracy,
precision, system suitability, range, robustness
and specificity
2 Justification shall be provided for
selection of acceptance criteria of At initial stage firm adopted specification from
dissolution i.e NLT 80% (75% Q BP General chapter “Appendix XII B. Annex X:
value) after 45 minutes while Recommendation on dissolution testing” which
USFDA guidance document on states that “at least 80% of active substance is
Dissolution Testing and released within a specified time, typically 45min
Acceptance Criteria for Immediate- or less (75% Q value). However dissolution
Release Solid Oral Dosage Form specification was revised on 24 Jan 2020 before
Drug Products Containing High the testing of 3rd month stability interval from
Solubility Drug Substances 45 min to 30min as per CDER report of USFDA
recommends dissolution criterion approved reference product Glyxambi (NDA
as Q=80% in 30 minutes 206-073).
Decision: Approved with innovators specifications. The firm shall submit fee of Rs. 7500/-
for correction/pre-approval change in product specifications as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021.
374. Name and address of manufacturer / Applicant M/s The Searle Company Limited
F-319, S.I.T.E., Karachi, Pakistan.
Brand Name +Dosage Form + Strength Anzo D MR Capsule
Diary No. Date of R& I & fee Dy No. 2368 (PEC DRAP) Dated
17.10.2022 (duplicate)
Rs: 50,000/- 22-12-2017
Composition Each modified release capsule contains:
Diclofenac sodium…….75mg
Omeprazole…………….20mg
Pharmacological Group Anti-arthritis
Anti-ulcer
Finished Product Specification Innovator’s Specs.
Pack size & Demanded Price As per DPC
Approval status of product in Reference EMA Approved
Regulatory Authorities. Diotop 75 mg / 20 mg modified release
hard capsules
Me-too status Not Applicable
GMP status GMP inspection conduced on
07/07/2022
Capsule (General & General Antibiotic)
section approved.
Drug Anzo D MR Capsule
Diclofenac Sodium MR Omeprazole delayed release pellets:
pellets : M/s Alphamed Formulations Private Limited
M/s Alphamed
Manufacturer of API
Formulations Private
Limited
API Lot No. RD0149-017 8000201-010

Description of Pack
(Container closure
system)
Real time: 6 months
Time Period
Frequency
Batch No. 20PD-271 20PD-272 20PD-273
Date of Initiation 26-10.2020 26-10.2020 26-10.2020
No. of Batches 03
S. Documents To Be Provided Status
No.
Reference of previous approval of Firm has referred to onsite inspection report
1. applications with stability study data of the of their product for Tapendol (Tapentadol)
firm Tablets 75mg & 100mg on 11th March, 2019.
Further, the said panel inspection report was
meeting held on 14th – 16th May 2019. The
available for stability chamber. Chambers are
controlled and monitored through software.
Certificate of Analysis of API from both API Diclofenac sodium MR pellets 35%:
Manufacturer and Finished Product Firm has submitted COA of Diclofenac
manufacturer. sodium MR pellets 35% (Batch No. RD0149-
017) from M/s ALPHAMED
FORMULATIONS PRIVATE LIMITED.
COA (Batch No. RD0149-017)) from M/s
submitted.
2.
Omeprazole Delayed release pellets
20%w/w:
Firm has submitted COA of Omeprazole
Delayed release pellets 20%w/w (Batch No.
8000201-010.) from M/s ALPHAMED
FORMULATIONS PRIVATE LIMITED.
COA (Batch No. 8000201-010.)) from M/s
submitted
3. API Manufacturer & Finished Product Submitted
manufacturer
Stability study data of API from API Diclofenac sodium MR pellets 35%:
manufacturer The firm has submitted copy of accelerated,
06 Months (40°C ± 2°C & 75±5%RH) &
long term, 36 Months (30°C ± 2°C &
65±5%RH) stability study reports of 03
batches
4. Omeprazole Delayed release pellets
20%w/w:
The firm has submitted copy of accelerated,
06 Months (40°C ± 2°C & 75±5%RH) &
long term, 36 Months (30°C ± 2°C &
65±5%RH) stability study reports of 03
batches
Approval of API/ DML/GMP certificate of Firm has submitted copy of GMP certificate
API manufacturer issued by concerned No. L.Dis.No:93420/TS/2022 by M/s
regulatory authority of country of origin. ALPHAMED FORMULATIONS PRIVATE
5. LIMITED issued by Drugs Control
Administration Government of Telangana.
..
Documents for the procurement of API with Diclofenac sodium pellets 35%:
approval from DRAP (in case of import). Firm has submitted import License dated 02-
12-2019 confirming import of 5Kg
Diclofenac sodium MR pellets 35% w/w
from M/s ALPHAMED FORMULATIONS
PRIVATE LIMITED for Batch # RD0149-
017.
6.
Omeprazole Delayed release pellets 20%w/w
Firm has submitted import License dated 02-
12-2019 confirming import of 1.8Kg
Omeprazole Delayed release pellets 20%w/w
from M/s ALPHAMED FORMULATIONS
PRIVATE LIMITED for Batch # 8000201-
010.
Protocols followed for conduction of stability
7. Submitted
study
Drug-excipients compatibility studies (where Since there is only encapsulation of pellets
applicable) carried out at FPP mfg site, no additional
9.
excipients are required hence compatibility
studies are not performed.
Complete batch manufacturing record of The firm has manufactured three stability
three stability batches. batches of Anzo D MR Capsule and has
submitted copy of complete batch
manufacturing. Details are as under:
Anzo D MR Capsule (75mg+20mg)
10.
2500 October
20PD-271
capsules 2020
2500 October
20PD-272
capsules 2020
2500 October
20PD-273
capsules 2020
Record of comparative dissolution data Firm has submitted Comparative dissolution
(where applicable) study of their product against Aristo 75/20
capsule :
Product of
Feature Reference M/s The
product Searle
Company
Brand Aristo capsule Anzo D MR
name 75mg + 20mg capsule
11.
Batch No. 1394180100 20PD-271
1. pH 1.2 HCl buffer (omeprazole)

4. purified water (diclofenac sodium)
on the basis of similarity factor (f2) result i.e
NLT 50 of dissolution profile of both API in
test product and reference product, both
products are similar.
12. Submitted
testing.
Record of Digital data logger for temperature Firm has submitted record of digital data
14. and humidity monitoring of stability logger for temperature and humidity
chambers (real time and accelerated) monitoring of stability chambers.
• Permission/approval for manufacturing omeprazole delayed release pellets from relevant
DCA.
• Analytical Method Validation studies to be submitted by the firm.
• Justify selection of Aristo 75/20 capsule for conducting comparative dissolution profile.
Give details of aforementioned brand i.e manufacturer, approval status etc
• Whether omeprazole pellets are tested in acetate medium or not, its not clear in profile.
Clarify the results/release profile of each API tested in different mediums and conclude
results accordingly, in CDP report
• Innovator (EMA approved ) product is Each modified release capsule contains 75 mg
diclofenac sodium (25 mg as gastroresistant pellets and 50 mg as prolonged release pellets)
and 20 mg of omeprazole (gastro-resistant pellets) however MR pellets of diclofenac sodium
used by the firm has to be clarified in this regard.
• Method of analytical testing to be submitted from pellets manufacturer.
• Drug excipient computability (carried out by pellets manufacturer) to be submitted.
• Justification to be provided for selection of acceptance criteria of dissolution (Q value,
dissolution time, sampling time and medium etc)
Decision: Registration Board deferred the application for above mentioned shortcomings
within 6 months.
375. Name, address of Applicant / Marketing M/s The Searle Company Limited
Authorization Holder F-319, S.I.T.E., Karachi, Pakistan.
Name, address of Manufacturing site. M/s The Searle Company Limited F-319, S.I.T.E.,
Karachi, Pakistan.
☐ Importer
☐ Export sale
PRU-CIC 1mg tablet
name
Active Pharmaceutical ingredient (API) Prucalopride……………..1mg
per unit
Pharmacotherapeutic Group of (API) Anti-constipation agent
N.A
specifications
authorities Motegrity Tablet
For generic drugs (me-too status) Not applicable
GMP status of the Finished product GMP inspection conduced on 07/07/2022
manufacturer
Name and address of API manufacturer. M/s Symed Labs Limited, India
Address: Symed Labs Limited (UNIT-VI) Sy. No.

744 & 745 and 750 to 753,
Mandolla gudem (Village), Choutuppal (Mandal),
Yadadri District – 508252 Telangana, India
physical form, solubility, manufacturers,
characterization, impurities, specifications,
submitted.
process and controls, characterization, impurities,
substance
Months
Batches: (6PCS0010817, 6PCS0020817,
6PCS0030817)
months
Batches: (6PCS0010817, 6PCS0020817,
6PCS0030817)

batch formula, pharmaceutical development and
analytical procedure, analytical method validation
comparative dissolution profile against the innovator product i.e. Resolor 1mg
tablet (by M/s. Takeda UK Ltd) by performing
quality tests (Appearance, Disintegration time,
Assay, content uniformity, Dissolution and
impurity testing)
Analytical method validation/verification Method validation studies have been submitted
of product including Linearity, Accuracy, and Precision
including Repeatability & Intermediate Precision,
Robustness and Specificity.
Manufacturer of API M/s Symed Labs Limited
Address: Symed Labs Limited (UNIT-VI) Sy. No. 744 & 745 and 750
to 753, Mandolla gudem (Village), Choutuppal (Mandal), Yadadri
District – 508252 Telangana, India
API Lot No. 6PCS0010420

Description of Pack
Alu/Alu blisters
Batch No. 20PD-331 20PD-332 20PD-333
No. of Batches 03
applications with stability study data of their product for Tapendol (Tapentadol) Tablets
the firm (if any) 75mg & 100mg on 11th March, 2019. Further, the
said panel inspection report was discussed in 289th
Drug Registration Board meeting held on 14th –
16th May 2019. The case was approved and the
inspection report confirms following points:
The HPLC software is 21CFR Compliant as per
and utilities are GMP compliant..
Approval of API/ DML/GMP certificate Copy of GMP certificate (65931/TS/2021) issued
of API manufacturer issued by concerned to M/s
regulatory authority of country of origin. Symed Labs Limited (UNIT-VI) Sy. No. 744 &
745 and 750 to 753, Mandolla gudem (Village),
Choutuppal (Mandal), Yadadri District – 508252
Telangana, India
issued by Drug Control Administration,
Government of Telangana valid till 14-09-2022 is
submitted
Documents for the procurement of API Firm has submitted copy of following invoices
with approval from DRAP (in case of specifying:
import).
0.070kg of Prucalopride Succinate (invoice #
2907/20) Batch No. 6PCS0010420 attested by AD
(I&E), Karachi dated 24-09-2020 is submitted
Data of stability batches will be Firm has submitted complete record of testing of
supported by attested respective all batches along with chromatograms, raw data
documents like chromatograms, Raw data sheets, COA and summary data sheets.
sheets, COA, summary data sheets etc.
Compliance Record of HPLC software Firm has submitted audit trail record of product
21CFR & audit trail reports on product testing of HPLC.
testing
Record of Digital data logger for Firm has submitted record of digital data logger for
accelerated)
Section# Observations Firm’s response (dated 20th October,

2022)
1.6.5 GMP certificate issued to M/s Firm submitted document from Drug Substance
Symed Labs Limited (UNIT- manufacturer i.e M/s Symed Labs Limited (UNIT-
VI) India VI) India, stating “GMP certificate is under
Is valid till 14-09-2022. renewal and expected to be received by end of
Hence valid GMP certificate October 2022.”
for the manufacturer of
Prucalopride Succinate to be
submitted .
3.2.P.5.1 MHRA Public assessment Firm has taken the dissolution specification from
report of the reference product FDA assessment report of innovator “Motegrity
recommends dissolution tablet”
specifications as “More than NDA 210166 which specify following dissolution
80% dissolved in 10 minute”, parameters:
whereas firm has submitted
dissolution specifications as
“Not less than 80% (Q=75%)
in 20 minutes.
USFDA guidance document

on Dissolution Testing and
Acceptance Criteria for
Immediate-Release Solid Oral
Dosage Form Drug Products
Containing High Solubility
Drug Substances recommends Firm took above mentioned specification and tested
dissolution medium as “500 accordingly from initial stage to onward.
mL of 0.1N HCl in aqueous
medium” whereas dissolution
medium volume used by the
firm is 900ml
Justification to be provided
for selection of dissolution
parameters i.e
Acceptance criteria and
volume of dissolution
medium.
3.2.P.2 Batch No. of Resolor 1mg Firm has submitted CDP report now (No CDP-
tablet used for pharmaceutical 114/21-R)
equivalence has not been Wherein CDP has been performed as follows:
mentioned.
Product of
Feature Reference
Results of comparative M/s The Searle
product
dissolution profile conducted Company
in three BCS media across the Brand Resolor 1mg Pru-cic 1mg
physiological pH range along name Tablet tablet
with calculation of similarity Batch No. KLL1P02 20PD-331
factor f2 to be submitted. Comparative dissolution studies have been
The Average % release of both Drug substances in

all three mediums is more than 85% at 15 minutes
hence product is categorized as very rapidly
dissolving drug, there is no need to calculate f2
value. The CDP of Pru-cic 1mg tablet against
Resolor 1mg Tablet shows equivalence.
Decision: Approved with innovator’s specifcations. The firm shall submit fee of Rs. 7500/- for
commitment submitted in the registration application
376. Name, address of Applicant / Marketing M/s The Searle Company Limited F-319, S.I.T.E.,
Authorization Holder Karachi, Pakistan.
Name, address of Manufacturing site. M/s The Searle Company Limited F-319, S.I.T.E.,
Karachi, Pakistan.
☐ Importer
☐ Export sale
PRU-CIC 2 mg tablet
name
Active Pharmaceutical ingredient (API) Prucalopride……………..2mg
per unit
Pharmacotherapeutic Group of (API) Anti-constipation agent
N.A
specifications
authorities Motegrity Tablet
For generic drugs (me-too status) Not applicable
GMP status of the Finished product GMP inspection conduced on 07/07/2022
manufacturer
Name and address of API manufacturer. M/s Symed Labs Limited, India
Address: Symed Labs Limited (UNIT-VI) Sy. No.
744 & 745 and 750 to 753,
Mandolla gudem (Village), Choutuppal (Mandal),
Yadadri District – 508252 Telangana, India
physical form, solubility, manufacturers,
submitted.
process and controls, characterization, impurities,
substance
Months
Batches: (6PCS0010817, 6PCS0020817,
6PCS0030817)
months
Batches: (6PCS0010817, 6PCS0020817,
6PCS0030817)

batch formula, pharmaceutical development and
analytical procedure, analytical method validation
comparative dissolution profile against the innovator product i.e. Resolor 2mg
tablet (by M/s. Takeda UK Ltd) by performing
quality tests (Appearance, Disintegration time,
Assay, content uniformity, Dissolution and
impurity testing)
including Repeatability & Intermediate Precision,
Robustness and Specificity.
Manufacturer of API M/s Symed Labs Limited
Address: Symed Labs Limited (UNIT-VI) Sy. No. 744 & 745 and 750
to 753, Mandolla gudem (Village), Choutuppal (Mandal), Yadadri
District – 508252 Telangana, India
API Lot No. 6PCS0010420
Description of Pack
Alu/Alu blisters
Batch No. 20PD-334 20PD-335 20PD-336
No. of Batches 03
applications with stability study data of their product for Tapendol (Tapentadol) Tablets
the firm (if any) 75mg & 100mg on 11th March, 2019. Further, the
said panel inspection report was discussed in 289th
Drug Registration Board meeting held on 14th –
16th May 2019. The case was approved and the
and utilities are GMP compliant..
Approval of API/ DML/GMP certificate Copy of GMP certificate (65931/TS/2021) issued
of API manufacturer issued by concerned to M/s
regulatory authority of country of origin. Symed Labs Limited (UNIT-VI) Sy. No. 744 &
745 and 750 to 753, Mandolla gudem (Village),
Choutuppal (Mandal), Yadadri District – 508252
Telangana, India
issued by Drug Control Administration,
Government of Telangana valid till 14-09-2022 is
submitted
Documents for the procurement of API Firm has submitted copy of following invoices
with approval from DRAP (in case of specifying:
import).
0.070kg of Prucalopride Succinate (invoice #
2907/20) Batch No. 6PCS0010420 attested by AD
(I&E), Karachi dated 24-09-2020 is submitted
Data of stability batches will be Firm has submitted complete record of testing of
supported by attested respective all batches along with chromatograms, raw data
documents like chromatograms, Raw data sheets, COA and summary data sheets.
sheets, COA, summary data sheets etc.
Compliance Record of HPLC software Firm has submitted audit trail record of product
21CFR & audit trail reports on product testing of HPLC.
testing
Record of Digital data logger for Firm has submitted record of digital data logger for
accelerated)
Section# Observations Firm’s response (dated 20th October, 2022)

1.6.5 GMP certificate issued to M/s Firm submitted document from Drug Substance
Symed Labs Limited (UNIT- manufacturer i.e M/s Symed Labs Limited (UNIT-
VI) India VI) India, stating “GMP certificate is under
Is valid till 14-09-2022. Hence renewal and expected to be received by end of
valid GMP certificate for the October 2022.”
manufacturer of Prucalopride
Succinate to be submitted
3.2.P.5.1 MHRA Public assessment Firm has taken the dissolution specification from
report of the reference product FDA assessment report of innovator “Motegrity
recommends dissolution tablet”
specifications as “More than NDA 210166 which specify following dissolution
80% dissolved in 10 minute”, parameters:
whereas firm has submitted
dissolution specifications as
“Not less than 80% (Q=75%)
in 20 minutes.
USFDA guidance document on

Dissolution Testing and
Acceptance Criteria for
Immediate-Release Solid Oral
Dosage Form Drug Products
Containing High Solubility
Drug Substances recommends Firm took above mentioned specification and tested
dissolution medium as “500 accordingly from initial stage to onward.
mL of 0.1N HCl in aqueous
medium” whereas dissolution
medium volume used by the
firm is 900ml
Justification to be provided for
selection of dissolution
parameters i.e
Acceptance criteria and
volume of dissolution medium.
3.2.P.2 Batch No. of Resolor 2mg Firm has submitted CDP report now (No CDP-
tablet used for pharmaceutical 115/21-R)
equivalence has not been Wherein CDP has been performed as follows:
mentioned.
Product of
Feature Reference
Results of comparative M/s The Searle
product
dissolution profile conducted Company
in three BCS media across the Brand Resolor 2mg Pru-cic 2mg
physiological pH range along name Tablet tablet
with calculation of similarity Batch No. LFL6T00 20PD-334
factor f2 to be submitted. Comparative dissolution studies have been
The Average % release of both Drug substances in

all three mediums is more than 85% at 15 minutes
hence product is categorized as very rapidly
dissolving drug, there is no need to calculate f2
value. The CDP of Pru-cic 2mg tablet against
Resolor 2mg Tablet shows equivalence.
Decision: Approved with innovator’s specifcations. The firm shall submit fee of Rs. 7500/-
for correction/pre-approval change in product specifications as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021.
In pursuance of decision of 133rd meeting of DRAP Authority held on 13th April 2022, wherein
it was decided to grant registration on priority basis to the pharmaceutical i.e one molecule for each
100,000 USD worth of export of medicines (to a maximum of 15 such molecules) during a fiscal year.
applications as communicated by Assistant Director (PR-I/EFD) vide letter No No.F.1-6/2019-PR-I
(EFD dated 06th October 2022.
377. Name and address of manufacturer / M/s AGP Limited B-23 S.I.T.E., Karachi,
Applicant Pakistan.
Brand Name +Dosage Form + Strength Sacuval 50mg Tablets
Diary No. Date of R& I & fee Dy No. 1809 (dated 17.10.2016) Rs:
50,000/- 17-10-2016
Sacubitril…….24.3mg
Valsartan…….25.7mg
Pharmacological Group Sacubitril: Angiotensin Receptor
Neprilysin Inhibitor (ARNI)
Valsartan: Angiotensin II receptor blocker
(ARBs)
Pack size & Demanded Price Rs 15000/- for 10’s
Rs 45000/- for 30’s
Approval status of product in Reference USFDA Approved
Regulatory Authorities. Entresto tablet 24/26
Me-too status Savesto 50 tablet (Reg No 093110) by M/s
Getz Pharma (Pvt) Ltd, Karachi
GMP status GMP conducted on 17-06-2021. (valid till
3rd June 2023)

Drug Sacuval 50mg Tablets
Name of Manufacturer M/s AGP Limited B-23 S.I.T.E., Karachi, Pakistan..
Nantong Chanyoo Pharmatech Co., Ltd
No. 2 Tonghai Si Road, Yangkou Chemical Industrial Park,
Manufacturer of API
Rudong Coastal Economic Development Zone, Nantong,
Jiangsu Province 226407, P.R China.
Sacubitril+ Valsartan (LCZ696)
API Lot No.
RD-LCZ696-201906241
Description of Pack
Real time : 30°C ± 2°C / 75% ± 5%RH
Real time: 6 months
Time Period
Frequency
Accelerated: 0,3,6,9,12 (months)
TR-560 TR-
Batch No. TR-559
561
200
0
Batch Size 2000 Tablets 2000 Tablets
Tab
let
11-
Manufacturing Date 11-2019 11-2019 201
9
02-
12-
Date of Initiation 02-12-2019 02-12-2019
201
9
No. of Batches 03
S. No. Documents To Be Provided Status
applications with stability study data of inspection report of their product for
the firm Glyzia XR (Sitagliptin/Metfrormin
HCl) Tablets 50/500 & 50/1000 on
26th September, 2018. Further, the
said panel inspection report was
discussed in 285th Drug Registration
Board meeting held on 3rd-4th
October,2018. The case was
approved and the inspection report
1. confirms following points:
with the firm.
available.
available for stability chamber..
are GMP compliant.
Certificate of Analysis of API from both Firm has submitted COA of API
API Manufacturer and Finished Product (Batch No. RD-LCZ696-201906241)
manufacturer. from M/s Nantong Chanyoo
Pharmatech Co., Ltd China. COA
2.
(Batch No. RD-LCZ696-201906241)
from M/s AGP Limited B-23
S.I.T.E., Karachi, Pakistan is also
submitted.
Method used for analysis of API from
3. both API Manufacturer & Finished Submitted
Stability study data of API from API The firm has submitted copy of
manufacturer accelerated, 06 Months (40°C ± 2°C
& 75±5%RH) & long term, 24
Months (30°C ± 2°C & 65±5%RH)
4.
stability study reports of 03 batches:
RD-LCZ696-201709181, RD-
LCZ696-201709241,
RD-LCZ696-201710091,
of API manufacturer issued by certificate of M/s Nantong Chanyoo
concerned regulatory authority of Pharmatech Co., Ltd China., China
5.
country of origin. issued by People’s Republic of
China NANTONG JIANGSU. The
Documents for the procurement of API Firm has submitted import License
with approval from DRAP (in case of No. 2299-DRAP dated 19-08-2019
6.
import). confirming import of 5.3Kg
Sacubitril+ Valsartan from M/s
Nantong Chanyoo Pharmatech Co.,
Ltd China for Batch No. RD-
LCZ696-201906241.

7. Submitted
stability study
Drug-excipients compatibility studies Firm has submitted that same
(where applicable) excipients has been used as used by
innovator “Enestro Tablets 24.3mg +
9. 25.7mg” by M/s Novertis
Pharmaceuticals UK Ltd. Therefore,
Drug-excipients compatibility
studies were not performed.
Complete batch manufacturing record of The firm has manufactured three
three stability batches. stability batches of Sacuval 50mg
Tablets 24.3mg + 25.7mg and has
submitted copy of complete batch
manufacturing. Details are as under:
Sacuval Tablets 24.3mg+25.7mg
10. Batch No. Bach size Mfg. Date
November
TR-559 2000 Tablets
2019
November
TR-560 2000 Tablets
2019
November
TR-561 2000 Tablets
2019
Record of comparative dissolution data Firm has submitted Comparative
(where applicable) dissolution study of their product
with Innovator’s Brand “Uperio
200mg tablet”. The details are as
follows:
Referenc
e product
Test
by M/s
Feature product by
Novartis
M/s AGP
pharma
Limited
Pakistan
Ltd
Entresto Sacuval
11. Brand
50mg 50mg
name
tablet Tablet
Batch
TW 724 TR-560
No.
mediums:
On the basis of similarity factor (f2)
result i.e NLT 50 of dissolution
profile of both API Sacubitril and
Valsartan in test product and
reference product, both products are
similar.

12. Submitted
testing.
Record of Digital data logger for Firm has submitted record of digital
temperature and humidity monitoring of data logger for temperature and
14.
stability chambers (real time and humidity monitoring of stability
accelerated) chambers.
S.no
Observation Reply
.
Drug Substance used in reference product
is “sacubitril valsartan sodium salt Firm has used Sacubitril / Valsartan sodium salt
1. complex’ while Drug Substance used in complex in applied formulation. The same API
instant application as “sacubitril valsartan claim mentioned has been verified from BMR.
complex”, salt form to be clarified.
Stability results of water in the raw material not
The absence of a test for water content has
showing any significant change at higher RH
to be justified since water content may
(75%) of accelerated condition that is why test of
increase above 60% RH condition,
2. water content not incorporated in the product
however slightly increased water content
specification. Moreover, as per EMA Assessment
observed during stability studies had no
report, during stability studies water content had
impact on product performance.
no impact on product performance.
Identification test has not been performed IR method are used for the Identification in the
by using IR method since the individual raw material while in product only HPLC method
active substance and the co-crystal used.
3. complex are readily distinguished by IR HPLC method is also well established
method. Identification test of innovator identification technique in pharmacopoeial
product (Entresto) has been performed products.
using both IR and HPLC technique.
If both the test and innovator / reference
product show more than 85% dissolution
within 15minutes, the profiles are
A f2 calculation required for pH 1.2 HCl buffer
considered similar in that particular
result, same default calculation template used in
medium and hence calculation of f2 factor
other mediums. Hence both results similarity
4. is not required. Both Test product and
factor more than 50 or results showing more than
reference products show more than 85%
85% dissolution within 15minutes conclusion is
dissolution (both sacubitril and valsartan)
satisfactory.
within 15minutes in pH 4.5 Acetate buffer
and pH 6.8 Phosphate buffer medium then
why f2 factor has been calculated.
GMP Certificate of M/s Nantong Chanyoo
Pharmatech Co., Ltd China., issued by
Firm has submitted copy of DML (No Su
People’s Republic of China NANTONG
5. 20160512) (valid till 02.12.2025) issued by
JIANGSU is valid till 05-05-2022. Submit
Jiangsu Drug Administration.
valid/updated GMP status of API
manufacturer.
Decision: Approved
378. Name and address of M/s AGP Limited B-23 S.I.T.E., Karachi, Pakistan.
manufacturer / Applicant
Brand Name +Dosage Form + Sacuval 100mg Tablets
Strength
Diary No. Date of R& I & fee Dy No. 1799 (dated 17/10/2016), Rs: 50,000/- 17-10-2016
Pharmacological Group Sacubitril: Angiotensin Receptor Neprilysin Inhibitor
(ARNI)
Valsartan: Angiotensin II receptor blocker (ARBs)
Pack size & Demanded Price Rs 30,000/- for 10’s
Rs 90,000/- for 30’s
Reference Regulatory Entresto tablet 49/51
Authorities.
Me-too status Savesto 100 tablet (Reg No 093111) by M/s Getz Pharma
(Pvt) Ltd, Karachi
GMP status GMP conducted on 17-06-2021. (valid till 3rd June 2023)

Nantong Chanyoo Pharmatech Co., Ltd
No. 2 Tonghai Si Road, Yangkou Chemical Industrial Park, Rudong
Manufacturer of API
Coastal Economic Development Zone, Nantong, Jiangsu Province
226407, P.R China.China
API Lot No.
RD-LCZ696-201906241
Description of Pack
Real time : 30°C ± 2°C / 75% ± 5%RH
Real time: 6 months
Time Period
Frequency
Manufacturing
11-2019 11-2019 11-2019
Date
Date of
27-11-2019 27-11-2019 27-11-2019
Initiation
No. of
03
Batches
Date of
21-04-2021 (Dy No. 1136 PEC, DRAP)
Submission
Reference of previous Firm has referred to onsite inspection report of their product
approval of applications with for Glyzia XR (Sitagliptin/Metfrormin HCl) Tablets 50/500 &
stability study data of the firm 50/1000 on 26th September, 2018. Further, the said panel
Board meeting held on 3rd-4th October,2018. The case was
approved and the inspection report confirms following points:
1. The HPLC software is 21CFR Compliant as per record
Adequate monitoring and control are available for stability
chamber..
Related manufacturing area, equipment, personnel and utilities
are GMP compliant.
Certificate of Analysis of API Firm has submitted COA of API (Batch No. RD-LCZ696-
from both API Manufacturer 201906241) from M/s Nantong Chanyoo Pharmatech Co., Ltd
2. and Finished Product China. COA (Batch No. RD-LCZ696-201906241) from M/s
manufacturer. AGP Limited B-23 S.I.T.E., Karachi, Pakistan is also
submitted.
Method used for analysis of
API from both API
3. Submitted
Stability study data of API The firm has submitted copy of accelerated, 06 Months (40°C
from API manufacturer ± 2°C & 75±5%RH) & long term, 24 Months (30°C ± 2°C &
4. 65±5%RH) stability study reports of 03 batches:
RD-LCZ696-201709181, RD-LCZ696-201709241,
RD-LCZ696-201710091,
Approval of API/ DML/GMP Firm has submitted copy of GMP certificate of M/s Nantong
certificate of API manufacturer Chanyoo Pharmatech Co., Ltd China., China issued by
5.
issued by concerned regulatory People’s Republic of China NANTONG JIANGSU. The
authority of country of origin. certificate is valid till 05-05-2022.
Documents for the Firm has submitted import License No. 2299-DRAP dated 19-
procurement of API with 08-2019 confirming import of 5.3Kg Sacubitril+ Valsartan
6.
approval from DRAP (in case from M/s Nantong Chanyoo Pharmatech Co., Ltd China for
of import). Batch No. RD-LCZ696-201906241.
7. Submitted
conduction of stability study
Method used for analysis of Submitted
8.
FPP
Drug-excipients compatibility Firm has submitted that same excipients has been used as used
studies (where applicable) by innovator “Enestro Tablets 48.6mg + 51.4mg” by M/s
9.
Novertis Pharmaceuticals UK Ltd. Therefore, Drug-excipients
compatibility studies were not performed.
Complete batch manufacturing The firm has manufactured three stability batches of Sacuval
record of three stability Tablet 48.6mg + 51.4mg and has submitted copy of complete
batches. batch manufacturing. Details are as under:
10. November
TR-556 2000 Tablets
2019
November
TR-557 2000 Tablets
2019
November
TR-558 2000 Tablets
2019
Record of comparative Firm has submitted Comparative dissolution study of their
dissolution data product with Innovator’s Brand “Uperio 200mg tablet”. The
(where applicable) details are as follows:
Reference
product by Test product by
Feature
M/s Novartis M/s AGP
pharma Limited
Pakistan Ltd
Entresto Sacuval 100mg
Brand name
100mg tablet Tablet
11.
Batch No. TW 892 TR-557
Comparative dissolution studies have been performed in
following mediums:
On the basis of similarity factor (f2) result i.e NLT 50 of

dissolution profile of both API Sacubitril and Valsartan in test
product and reference product, both products are similar.
Data of 03 batches will be
supported by attested
12. Submitted
chromatograms, Raw data
sheets etc.
Compliance Record of HPLC Submitted
13. software 21CFR & audit trail
Record of Digital data logger Firm has submitted record of digital data logger for
for temperature and humidity temperature and humidity monitoring of stability chambers.
14. monitoring of stability
accelerated)
S.no. Observation Reply
Drug Substance used in reference product
is “sacubitril valsartan sodium salt Firm has used Sacubitril / Valsartan sodium salt
1. complex’ while Drug Substance used in complex in applied formulation. The same API
instant application as “sacubitril valsartan claim mentioned has been verified from BMR.
complex”, salt form to be clarified.
Stability results of water in the raw material not
The absence of a test for water content has
showing any significant change at higher RH
to be justified since water content may
(75%) of accelerated condition that is why test of
increase above 60% RH condition,
2. water content not incorporated in the product
however slightly increased water content
specification. Moreover, as per EMA Assessment
observed during stability studies had no
report, during stability studies water content had
impact on product performance.
no impact on product performance.
Identification test has not been performed
IR method are used for the Identification in the
by using IR method since the individual
raw material while in product only HPLC method
active substance and the co-crystal
used.
3. complex are readily distinguished by IR
HPLC method is also well established
method. Identification test of innovator
identification technique in pharmacopoeial
product (Entresto) has been performed
products.
using both IR and HPLC technique.
If both the test and innovator / reference
product show more than 85% dissolution
within 15minutes, the profiles are
A f2 calculation required for pH 1.2 HCl buffer
considered similar in that particular
result, same default calculation template used in
medium and hence calculation of f2 factor
other mediums. Hence both results similarity
4. is not required. Both Test product and
factor more than 50 or results showing more than
reference products show more than 85%
85% dissolution within 15minutes conclusion is
dissolution (both sacubitril and valsartan)
satisfactory.
within 15minutes in pH 4.5 Acetate buffer
and pH 6.8 Phosphate buffer medium then
why f2 factor has been calculated.
GMP Certificate of M/s Nantong Chanyoo
Pharmatech Co., Ltd China., issued by
People’s Republic of China NANTONG
JIANGSU is valid till 05-05-2022. Submit
valid/updated GMP status of API
manufacturer.
379. Name and address of M/s AGP Limited B-23 S.I.T.E., Karachi,
manufacturer / Applicant Pakistan.
Brand Name +Dosage Form + Sacuval 200mg Tablets
Strength
Diary No. Date of R& I & fee Dy No. 1800 (dated 17/10.2016), Rs: 50,000/-
17-10-2016
Pharmacological Group Sacubitril: Angiotensin Receptor Neprilysin
Inhibitor (ARNI)
Valsartan: Angiotensin II receptor blocker
(ARBs)
Pack size & Demanded Price Rs 60,000/- for 10’s
Rs 180,000/- for 30’s
Reference Regulatory Entresto tablet 97/103
Authorities.
Me-too status Savesto 200 tablet (Reg No 093112) by M/s
Getz Pharma (Pvt) Ltd, Karachi
GMP status GMP conducted on 17-06-2021. (valid till 3rd
June 2023)

Manufacturer of API Nantong Chanyoo Pharmatech Co., Ltd China
API Lot No.
RD-LCZ696-201906241
Description of Pack
Real time : 30°C ± 2°C / 75% ± 5%RH
Real time: 6 months
Time Period
Frequency
Manufacturing
11-2019 11-2019 11-2019
Date
Date of
26-11-2019 26-11-2019 26-11-2019
Initiation
No. of
03
Batches
Date of
21-04-2021 (Dy No. 1135 PEC, DRAP)
Submission
Reference of previous Firm has referred to onsite inspection report
approval of applications with of their product for Glyzia XR
stability study data of the firm (Sitagliptin/Metfrormin HCl) Tablets 50/500
& 50/1000 on 26th September, 2018. Further,
the said panel inspection report was discussed
in 285th Drug Registration Board meeting
held on 3rd-4th October,2018. The case was
approved and the inspection report confirms
1.
following points:
available for stability chamber..
Certificate of Analysis of API Firm has submitted COA of API (Batch No.
from both API Manufacturer RD-LCZ696-201906241) from M/s Nantong
and Finished Product Chanyoo Pharmatech Co., Ltd China. COA
2.
manufacturer. (Batch No. RD-LCZ696-201906241) from
M/s AGP Limited B-23 S.I.T.E., Karachi,
Pakistan is also submitted.
Method used for analysis of
API from both API
3. Submitted
Stability study data of API The firm has submitted copy of accelerated,
from API manufacturer 06 Months (40°C ± 2°C & 75±5%RH) & long
term, 24 Months (30°C ± 2°C & 65±5%RH)
4. stability study reports of 03 batches:
RD-LCZ696-201709181, RD-LCZ696-
201709241,
RD-LCZ696-201710091,
Approval of API/ DML/GMP Firm has submitted copy of GMP certificate
certificate of API manufacturer of M/s Nantong Chanyoo Pharmatech Co.,
5. issued by concerned regulatory Ltd China., China issued by People’s
authority of country of origin. Republic of China NANTONG JIANGSU.
Documents for the Firm has submitted import License No. 2299-
procurement of API with DRAP dated 19-08-2019 confirming import
6. approval from DRAP (in case of 5.3Kg Sacubitril+ Valsartan from M/s
of import). Nantong Chanyoo Pharmatech Co., Ltd China
for Batch No. RD-LCZ696-201906241.
7. Submitted
conduction of stability study
Method used for analysis of Submitted
8.
FPP
Drug-excipients compatibility Firm has submitted that same excipients has
studies (where applicable) been used as used by innovator ‘Enestro
Tablets 97.2mg + 102.8mg’ by M/s Novertis
9.
Pharmaceuticals UK Ltd. Therefore, Drug-
excipients compatibility studies were not
performed.
Complete batch manufacturing The firm has manufactured three stability
record of three stability batches of Sacuval 200mg Tablets 97mg +
batches. 103mg and has submitted copy of complete
batch manufacturing. Details are as under:
10.
2000 November
TR-544
Tablets 2019
2000 November
TR-545
Tablets 2019
2000 November
TR-546
Tablets 2019
Record of comparative Firm has submitted Comparative dissolution
dissolution data study of their product with Innovator’s Brand
(where applicable) “Uperio 200mg tablet”. The details are as
follows:
Reference
product by
M/s Test product by
Feature
Novartis M/s AGP
pharma Limited
Pakistan
Ltd
Uperio
Brand Sacuval Tablets
200mg
11. name 97.2mg+102.8mg
tablet
Batch
TT213 TR545
No.
On the basis of similarity factor (f2) result i.e

NLT 50 of dissolution profile of both API
Sacubitril and Valsartan in test product and
reference product, both products are similar.
Data of 03 batches will be
supported by attested
12. Submitted
chromatograms, Raw data
sheets etc.
Compliance Record of HPLC Submitted
13. software 21CFR & audit trail
Record of Digital data logger Firm has submitted record of digital data
for temperature and humidity logger for temperature and humidity
14. monitoring of stability monitoring of stability chambers.
accelerated)
S.no. Observation Reply
Drug Substance used in reference
product is “sacubitril valsartan Firm has used Sacubitril / Valsartan sodium
sodium salt complex’ while Drug salt complex in applied formulation. The
1.
Substance used in instant application same API claim mentioned has been verified
as “sacubitril valsartan complex”, salt from BMR.
form to be clarified.
Stability results of water in the raw material
The absence of a test for water
not showing any significant change at higher
content has to be justified since water
RH (75%) of accelerated condition that is
content may increase above 60% RH
why test of water content not incorporated
2. condition, however slightly increased
in the product specification. Moreover, as
water content observed during
per EMA Assessment report, during stability
stability studies had no impact on
studies water content had no impact on
product performance.
product performance.
Identification test has not been
performed by using IR method since
IR method are used for the Identification in
the individual active substance and
the raw material while in product only
the co-crystal complex are readily
HPLC method used.
3. distinguished by IR method.
HPLC method is also well established
Identification test of innovator
identification technique in pharmacopoeial
product (Entresto) has been
products.
performed using both IR and HPLC
technique.
GMP Certificate of M/s Nantong
Chanyoo Pharmatech Co., Ltd China.,
issued by People’s Republic of China
NANTONG JIANGSU is valid till
05-05-2022. Submit valid/updated
GMP status of API manufacturer.
Decision: Approved with Innovator’s specifications. The firm shall submit fee of Rs.
7500/- for correction/pre-approval change in product specifications as per notification
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
studies throughout proposed shelf life and on accelerated studies for six months.
In pursuance of decision of 133rd meeting of DRAP Authority held on 13th April 2022,
wherein it was decided to grant registration on priority basis to the pharmaceutical i.e one molecule
for each 100,000 USD worth of export of medicines (to a maximum of 15 such molecules) during a
fiscal year.
380. Name, address of Applicant / Marketing M/s. SAMI Pharmaceuticals (Pvt.) Ltd. F-95,
Authorization Holder Off Hub River Road, S.I.T.E., Karachi –
75730, Pakistan
Name, address of Manufacturing site. M/s. SAMI Pharmaceuticals (Pvt.) Ltd. F-95,
Off Hub River Road, S.I.T.E., Karachi –
75730, Pakistan
☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand LAGITA DOUBLE ACTION Chewable
name Tablets
Strength / concentration of drug of Active Each Chewable Tablet contains:
Pharmaceutical ingredient (API) per unit Sodium Alginate BP……250mg
Sodium Bicarbonate BP…..106.5mg
Calcium Carbonate BP…..187.5mg
Pharmaceutical form of applied drug One layer of the tablet is colored pink with a
slightly mottled appearance, with the other
layer being white, Flat, Circular, bilayer tablet
with beveled edges
Pharmacotherapeutic Group of (API) Antacid
Innovators Specs.
specifications
The status in reference regulatory Gaviscon Double Action Mint flavor
authorities Chewable Tablets by Reckitt Benckiser
Healthcare (UK) Limited, MHRA Approved
GMP status of the Finished product GMP Certificate issued date 28-08-2019
manufacturer Tablet (General/General antibiotic) section is
approved dated 22.06.2018
Name and address of API manufacturer. Sodium Alginate:
QingDao Bright Moon Seaweed Group Co. Ltd
NO.777, Mingyue Road, Huangdao District
Qingdao China
Sodium Bicarbonate:
Solvay Peroxythai Limited 1, I-3A Road,
Tambol Map Ta Phut, Amphur Muang, Rayong
21150, Thailand
Calcium Carbonate:
Sudeep Pharma Private Limited
Plot No. 129/1/A, G.I.D.C., Estate, Nandesari -
391 340. Dist. Vadodara.
controls, characterization, impurities,
specification, container closure system and
Stability studies Sodium Alginate
months
months
Batches: (H051708011, H051708013,
H051708012)
Sodium bicarbonate
months
months
Batches: (MTP25417, MTP27317, MTP28017)
Calcium Carbonate
months
months
Batches: (17B/CP/030, 17B/CP/031,
17B/CP/032)
controls, pharmaceutical development,
impurities, individual impurity and total
impurity, specifications, analytical procedure
and its validation studies, batch analysis and
comparative dissolution profile established against the innovator product i.e.
GAVISCON double Action Tablet by M/s.
Reckitt Benckiser Healthcare (UK) Ltd. (batch
no. 107801) by performing quality tests
(Appearance, Average weight, Taste, Raft
strength, Acid neutralizing capacity, Firability,
Assay, Microbial Limit Test
CDP not required here since formulation is

antacid preparation which has non systemic use.
.
including Repeatability & Intermediate
Precision, Robustness and Specificity.
Manufacturer of API Sodium alginate: QingDao Bright Moon Seaweed Group Co. Ltd
Sodium bicarbonate: Solvay Peroxythai Limited
Calcium carbonate: Sudeep Pharma Private Limited
API Lot No. Sodium alginate: H052002087
Sodium bicarbonate: MTP01820
Calcium carbonate: 18C/CP/080
Description of Pack
(Container closure Alu-PVC blister packed in unit carton
system)
No. of Batches 03
Reference of previous approval of The firm has submitted reference of last onsite
applications with stability study data of the panel inspection for instant dosage form
firm (if any) conducted during last two years i.e. EMPOLI
(Empagliflozin) 10mg & 25mg Tablets which
was presented in 290th meeting of the
registration board & hence approved &
registered by registration board Date of
inspection: 13th June 2019. The inspection
report confirms following points
• The HPLC software is 21CFR Compliant

for stability chamber. Chambers are
controlled and monitored through software
having alarm system for alerts as well.
Approval of API/ DML/GMP certificate Sodium alginate:
of API manufacturer issued by concerned Copy of GMP certificate No. SD20180790
regulatory authority of country of origin. issued to Qingdao Bright moon Seaweed Group
Co., Ltd valid till 23/10/2023.
Sodium bicarbonate:
Copy of GMP certificate No. 1-2-07-17-20-
00013 issued to Solvay Peroxythai Limited
valid till 25/08/2022
Calcium carbonate:
Copy of GMP certificate No. 20051985 issued
to Sudeep Pharma Private Limited valid till
17/05/2023
Documents for the procurement of API Sodium Alginate:
with approval from DRAP (in case of Attached copy of commercial invoice (Invoice#
import). BMM20080 dated 27th March 2020, with
received quantity i.e. 5000Kgs) for the purchase
of Sodium Alginate from Qingdao Bright Moon
Seaweed Group Co. Ltd. with attestation of
DRAP dated 19th May 2020
Sodium Bicarbonate:
Attached copy of commercial invoice (with
received quantity i.e. 24Kgs) for the purchase of
Sodium Bicarbonate from Solvay Peroxythai
Limited with courier slip dated 14th March
2020
Calcium Carbonate:
Attached copy of commercial invoice (Invoice#
SPPL/EX021/18-19 dated 17th April 2018,
with received quantity i.e. 12 Kg for the
purchase of Calcium Carbonate from Sundeep
Pharma PrivateLimited with attestation of
DRAP dated 30th April 2018
Data of stability batches will be supported Firm has submitted complete record of testing
by attested respective documents like of all batches along with raw data sheets and
Chromatograms are not applicable since
spectroscopic method are used for analysis of
drugs.
Compliance Record of HPLC software Not applicable
testing
Record of Digital data logger for Firm has submitted record of digital data logger
temperature and humidity monitoring of for temperature and humidity monitoring of real
accelerated)

Good Manufacturing Practice (GMP) Copy of GMP certificate No. 1-2-07-
certificate of the Drug Substance / API 17-20-00013 issued to Solvay
(sodium bicarbonate) manufacturer with Peroxythai Limited valid till
valid period of time. 25/08/2022 is provided.
Firm has submitted notification from

Food and Drug Administration,
Thailand
Wherein it is stated that GMP
certificate of manufacturer issued by
FDA that expires before 31st
Dec,2022 are considered valid till 31st
Dec,2022 due to ongoing threat of
COVI-19 pandemic.
Updated GMP status of FPP manufacturer Firm has submitted GMP certificate
to be submitted. dated 03.08.2022 valid till 2 years.
The information on tablet hardness and Firm has submitted specification of
disintegration is not provided (as hardness and disintegration as
recommended by USFDA guidance follows
document on quality attributes of chewable Disintegration time 35 min
tablet). Justify it Hardness NLT 7Kp and NMT
15Kp
While USFDA recommends that
hardness for chewable tablets be
kept low (˂12 kp). A higher
hardness value (>12 kp) may be
considered if justified.
Detailed analytical procedures used for Complied
testing the drug product should be provided.
Documents for the procurement of API with Not complied.
approval from DRAP is required. Only Firm has submitted commercial
commercial invoices are provided under invoice (of sodium bicarbonate)
this section. only. Batch No/Lot No is not
verifiable. Clearance from DRAP is
also required for all three drug
substances.
Furthermore, CoA of relevant
batch from DS manufacturer and
FPP manufacturer is required for
all three drug substances.
CoA at each time interval is required in Complied
stability data.
Decision: Registration Board considered the case deferred the request for following
observations:
• Specification of hardness i.e NLT 7Kp and NMT 15Kp to be justified. Since USFDA
recommends hardness for chewable tablets as ˂12 kp.
• Commercial invoices and DRAP clearance certificate of all drug substances along
with CoA of relevant batches (from both Drug Substance and Finished Product
manufacturer).
• Approval of API/ DML/GMP certificate of API manufacturer issued by concerned
regulatory authority of country of origin
Registration applications of newly granted DML or New section (Human)

New DML
M/s Akhsah Pharmaceuticals (Pvt) Ltd, Plot No. 47, Street No S-10,RCCI,Industrial estate, Rawat
CLB in its 282nd meeting held on 31st August 2021, has considered and approved the grant of DML
by way of Formulation with following 3 sections:
Tablet Section (General)
Capsule Section (General)
Cream/ointment section (General)
381. M/s Akhsah Pharmaceuticals (Pvt) Ltd,

Plot No. 47, Street No S-
10,RCCI,Industrial estate, Rawat
M/s Akhsah Pharmaceuticals (Pvt) Ltd,
Name, address of Manufacturing site. Plot No. 47, Street No S-
☒ Manufacturer
☐ Importer
(contract giver)
☐Domestic sale
09/09/2022
Transa 250mg capsule
name
Each capsule contains:
Tranexamic acid…….250mg

Pharmacotherapeutic Group of (API) Anti fibrinolytic
JP specification
specifications
Proposed unit price As per Policy
PMDA (Japan) approved
authorities
Transamin 250mg capsule by M/s Hilton
pharma, Karachi.
DML grant inspection report not provided
Capsule section (General) is approved
manufacturer
dated 14.09.2021
Changzhou Yinsheng Pharmaceutical Co.,
Ltd. China
Module-II (Quality Overall Summary) impurities, specifications, analytical
control of excipients, reference standard,
studies of drug substance and drug product
is submitted.
The firm as submitted detail of
Module III (Drug Substance) controls, tests for impurities & related
substances, specifications, batch analysis
and justification of specification, container
substance
60 months
Stability studies
for 12 months
Batches:(100301, 100302, 100303)
Module-III (Drug Product): manufacturers, description of
process validation studies, specifications,
analytical procedure and validation studies
Pharmaceutical equivalence was
determined against Transamin 250mg
capsule (Batch No 141899) by M/s Hilton
Pharma. Quality parameters such as
identification, dissolution and assay were
compared against Transa 500mg capsule
(Batch No CP-02-T250 RT)
comparative dissolution profile CDP has been performed against the same
brand that is Transamin 250mg capsule
(Batch No 141899 in Acid media (pH 1.0-
1.2) in Acetate Buffer (pH 4.5) &
Complete CDP report is not provided

of product

Manufacturer of API Changzhou Yinsheng Pharmaceutical Co., Ltd. China
API Lot No. 2111002
Description of Pack
system)
Strength 500mg capsule
Batch No. CP-01-T250 CP-02-T250 CP-03-T250
No. of Batches 03
Reference of previous approval of Not applicable
firm (if any)
Approval of API/ DML/GMP certificate of Firm has submitted copy of GMP
API manufacturer issued by concerned certificate No. JS20170680 of Changzhou
regulatory authority of country of origin. Yinsheng Pharmaceutical Co., Ltd. China
20-06-2022.

import).

chromatograms,
sheets etc.
testing
accelerated)
Sr.# Observation Reply (dated 30.10.2022)

Valid Good Firm has submitted clarification regarding GMP of API
Manufacturing Practice manufacturer that Chinese Drug Regulatory Authority has
(GMP) certificate of declared that they will not issue new GMP from 31st
the Drug Substance / Dec,2019 and authority has refused for renewal.
API manufacturer DML# Su 20160123 valid till 16-12-2025 has been
issued by concerned verified form the website of NMP China:
regulatory authority of https://www.nmpa.gov.cn/datasearch/home-
country of origin to be index.html?79QlcAyHig6m=1670181120509#category=yp
provided
GMP status/inspection Inspection report for grant of DML has been provided
report of FPP (dated 24.08.2021)
manufacturer to be
submitted.
Provide results of Provided

analysis of relevant
batch(es) of Drug
Substance performed
by Drug Product
manufacturer used
during product
development and
with Certificate of
Analysis (COA) of the
Substance / API
manufacture.
Detailed analytical Provided

procedures for the
testing of drug
substance to be
provided by Drug
Analytical Method Provided
accuracy and
precision) performed
by the Drug Product
manufacturer to be
provided
For testing of Firm has submitted copy of CoA of working standard
Pharmacopeial Drug (Tranexamic acid batch no. 2108005) and clarified that
Substance, the use of The primary working standard has been given to us by API
primary reference manufacturer has already been qualified with the reference
standard is working standard
recommended, justify
use of working
standard for
Tranexamic acid
Detailed CDP report to Firm has submitted CDP report now Wherein CDP has
be provided wherein been performed as follows:
values for f1 and f2 are
calculated along with Reference
Feature Product of
results conclusion. product by M/s
M/s Akhsah
Hilton
Brand Transamin Transa 250mg
name 250mg cap cap
Batch No. 141899 CP-02-T250
following mediums:
Uniformity of dose is Provided calculation of uniformity of dose for all three
not provided in stability batches CP-01-T250, CP-02-T250, CP-03-T250
finished product
specification and
stability studies.
Documents for the Provided copy of commercial invoice (Invoice#
procurement of API FNDL21-8165 dated 14th January 2022, with received
quantity i.e. 14Kg) for the purchase of Tranexamic acid
with approval from from Changzhou Yinsheng Pharmaceutical Co., Ltd. China
DRAP is required with attestation of DRAP dated 17th Feb 2022
Decision: Approved.
382. M/s Akhsah Pharmaceuticals (Pvt) Ltd,

Plot No. 47, Street No S-
M/s Akhsah Pharmaceuticals (Pvt) Ltd,
Name, address of Manufacturing site. Plot No. 47, Street No S-
☒ Manufacturer
☐ Importer
(contract giver)
☐Domestic sale
09/09/2022
Transa 500mg capsule
name
Each capsule contains:
Tranexamic acid…….500mg

Pharmacotherapeutic Group of (API) Anti fibrinolytic
JP specification
specifications
PMDA (Japan) approved
authorities
Transamin 500mg capsule by M/s Hilton
pharma, Karachi.
GMP status of the Finished product DML grant inspection report not provided
manufacturer
Capsule section (General) is approved
dated 14.09.2021
Changzhou Yinsheng Pharmaceutical Co.,
Ltd. China
control of excipients, reference standard,
studies of drug substance and drug product
is submitted.
controls, tests for impurity, specifications,
60 months
Stability studies
for 12 months
Batches:(100301, 100302, 100303)
analytical procedure and validation studies
determined against Transamin 500mg
capsule (Batch No 143474) by M/s Hilton
Pharma. Quality parameters such as
identification, dissolution and assay were
Pharmaceutical equivalence and compared against Transa 500mg capsule
comparative dissolution profile (Batch No CP-01-T500)

brand that is Transamin 500mg capsule
(Batch No 143474) in Acid media (pH 1.0-
1.2) in Acetate Buffer (pH 4.5) &
CDP report is not submitted.

of product

Manufacturer of API Changzhou Yinsheng Pharmaceutical Co., Ltd. China
API Lot No. 2111002
Description of Pack
system)
Strength 500mg capsule
Batch No. CP-01-T500 CP-02-T500 CP-03-T500
No. of Batches 03
firm (if any)
Approval of API/ DML/GMP certificate of Firm has submitted copy of GMP
API manufacturer issued by concerned certificate No. JS20170680 of Changzhou
regulatory authority of country of origin. Yinsheng Pharmaceutical Co., Ltd. China
20-06-2022.

import).

chromatograms,
sheets etc.
testing
accelerated)
Valid Good Firm has submitted clarification regarding GMP of API
Manufacturing Practice manufacturer that Chinese Drug Regulatory Authority has
(GMP) certificate of declared that they will not issue new GMP from 31st
the Drug Substance / Dec,2019 and authority has refused for renewal.
API manufacturer DML# Su 20160123 valid till 16-12-2025 has been
issued by concerned verified form the website of NMP China:
regulatory authority of https://www.nmpa.gov.cn/datasearch/home-
country of origin to be index.html?79QlcAyHig6m=1670181120509#category=yp
provided
GMP status/inspection Inspection report for grant of DML has been provided
report of FPP (dated 24.08.2021)
manufacturer to be
submitted.
Provide results of Provided

analysis of relevant
batch(es) of Drug
Substance performed
by Drug Product
manufacturer used
during product
development and
with Certificate of
Analysis (COA) of the
Substance / API
manufacture.
Detailed analytical Provided

procedures for the
testing of drug
substance to be
provided by Drug
Analytical Method Provided
accuracy and
precision) performed
by the Drug Product
manufacturer to be
provided
For testing of Firm has submitted copy of CoA of working standard
Pharmacopeial Drug (Tranexamic acid batch no. 2108005) and clarified that
Substance, the use of The primary working standard has been given to us by API
primary reference manufacturer has already been qualified with the reference
standard is working standard
recommended, justify
use of working
standard for
Tranexamic acid
Detailed CDP report to Firm has submitted CDP report now Wherein CDP has
be provided wherein been performed as follows:
values for f1 and f2 are Reference
Feature Product of
calculated along with product by M/s
M/s Akhsah
results conclusion. Hilton
Brand Transamin Transa 500mg
name 500mg cap cap
Batch No. 143474 CP-02-T500
following mediums:
Uniformity of dose is Provided calculation of uniformity of dose for all three
not provided in stability batches CP-01-T500, CP-02-T500, CP-03-T500
finished product
specification and
stability studies.
Documents for the Provided copy of commercial invoice (Invoice#
procurement of API FNDL21-8165 dated 14th January 2022, with received
with approval from quantity i.e. 14Kg) for the purchase of Tranexamic acid
DRAP is required from Changzhou Yinsheng Pharmaceutical Co., Ltd. China
with attestation of DRAP dated 17th Feb 2022
Decision: Approved
383. M/s Akhsah Pharmaceuticals (Pvt) Ltd, Plot

No. 47, Street No S-10,RCCI,Industrial
estate, Rawat
M/s Akhsah Pharmaceuticals (Pvt) Ltd, Plot
Name, address of Manufacturing site. No. 47, Street No S-10,RCCI,Industrial
estate, Rawat
☒ Manufacturer
☐ Importer
giver)
☐Domestic sale
09/09/2022
Elox 250mg Tablet
name
Strength / concentration of drug of Active Levofloxacin hemihydrate eq to
Pharmaceutical ingredient (API) per unit Levofloxacin…………..….250mg

Pharmacotherapeutic Group of (API) Fluoroquinolone
USP specification
specifications
USFDA approved
authorities
Leflox 250mg tablet by M/s Getz pharma,
Pakistan.
Capsule section (General) is approved dated
manufacturer
14.09.2021
Name and address of API manufacturer. Zhejiang East-Asia Pharmaceutical Co Ltd
Firm has submitted QOS as per WHO QOS-
of specification, control of excipients,
and stability studies of drug substance and
controls, tests for impurity, specifications,
36 months
Stability studies Accelerated: 40°C ± 2°C / 75% ± 5%RH for
6 months
Batches:(DC-0401-1203001,
DC-0401-1203002, DC-0401-1203003)
process and controls, process validation
studies, specifications, analytical procedure
and validation studies batch analysis and
product.
Pharmaceutical equivalence was determined
against Leflox 250mg tablet by M/s Getz
pharma, Pakistan. (Batch No 1G016)
Quality parameters such as identification,
dissolution and assay were compared against
Elox 250mg Tablet (Batch No TB-01-E250)
Pharmaceutical equivalence and CDP has been performed against the same
comparative dissolution profile brand that is Leflox 250mg tablet by M/s
Getz pharma, Pakistan (Batch No 1G016) in
Acid media (pH 1.0-1.2) in Acetate Buffer
(pH 4.5) & Phosphate Buffer (pH 6.8). The
range.
CDP report is not provided.

of product

Manufacturer of API Zhejiang East-Asia Pharmaceutical Co Ltd China
API Lot No. DC-004-2110012
Description of Pack
system)
Strength 250mg Tablet
Batch No. TB-01-E250 TB-02-E250 TB-03-E250
No. of Batches 03
firm (if any)
Approval of API/ DML/GMP certificate of Not submitted

import).

chromatograms,
sheets etc.
testing
accelerated)
30.10.2022)
Valid Good Manufacturing Practice (GMP) Firm has submitted clarification
certificate of the Drug Substance / API regarding GMP of API
manufacturer issued by concerned manufacturer that Chinese Drug
regulatory authority of country of origin to Regulatory Authority has declared
be provided that they will not issue new GMP
from 31st Dec,2019 and authority
has refused for renewal.
GMP status/inspection report of FPP Inspection report for grant of DML
manufacturer to be submitted. has been provided (dated
24.08.2021)
Compatibility of the Drug Substance(s) IPA has been used along with
with excipients is not provided. Since Povidone. IPA get evaporated and
excipients used in applied product are dried granules get mixed with
different from innovator/reference product. API.
sodium starch glycolate has been
used as disintegrant instead of
croscarmillose sodium, which is
used by innovator, both has same
functions.
Remarks:
Drug excipients compatibility
studies is required for sodium
starch glycolate, PVPK30 and
silicon dioxide.
Detailed analytical procedures for the Provided
Drug Product manufacturer
Analytical Method Verification studies Provided
by the Drug Product manufacturer to be
provided
For testing of Pharmacopeial Drug Firm has submitted copy of CoA
Substance, the use of primary reference of working standard (Levofloxacin
standard is recommended, justify use of hemihydrate batch no. WS-ZFSX-
working standard for Levofloxacin 202101) and clarified that
The primary working standard has
been given to us by API
manufacturer has already been
qualified with the reference
working standard
Detailed CDP report to be provided Firm has submitted CDP report
wherein values for f1 and f2 are calculated now Wherein CDP has been
along with results conclusion. performed as follows:
Reference Product
Feature product by of
M/s Getz M/s
pharma Akhsah
Leflox Elox
Brand
250mg 250mg
name
tablet tablet
Batch TB-01-
1G016
No. E250
mediums:
The Average % release of Drug
substances in all three mediums is
more than 85% at 15 minutes
hence there is no need to calculate
f2 value. Whereas firm has
calculated both f1 and f2. The
values for f1 and f2 are in the
acceptable range.
Uniformity of dose is not provided in Provided calculation of uniformity
finished product specification and stability of dose for all three stability
studies. batches TB-01-E250, TB-02-E250
TB-03-E250
Documents for the procurement of API Provided copy of commercial
with approval from DRAP is required invoice (Invoice# LEV220113-L
dated 13th January 2022, with
received quantity i.e. 12Kg) for the
purchase of Levofloxacin
hemihydrate from Zhejiang East-
Asia Pharmaceutical Co Ltd.
China with attestation of DRAP
dated 02/03/2022
• Justification of difference in qualitative composition of excipients of applied product
from innovator.
• Valid DML/GMP certificate/approval of API in the name of Zhejiang East-Asia
Pharmaceutical Co Ltd China issued by concerned regulatory authority of China.

estate, Rawat
estate, Rawat
☒ Manufacturer
☐ Importer
giver)
☐Domestic sale
09/09/2022
Expel 5mg Tablet
name
Escitalopram Oxalate eq. to
Escitalopram………………….……..….5mg
Pharmacotherapeutic Group of (API) Anti-depressant
USP specification
specifications
USFDA approved
authorities
For generic drugs (me-too status) Estar 5mg tablet by M/s Pharmevo, Karachi
Tablet section (General) is approved dated
manufacturer
14.09.2021
Name and address of API manufacturer. Zhejiang Haisen Pharmaceutical Co Ltd
of specification, control of excipients, list of
reference standard used, container closure
Module III (Drug Substance) controls, tests for impurity & related
substances, specifications, batch analysis
and justification of specification, container
substance
months
Stability studies
6 months
Batches: (3619102201, 3619102202
3619102203)
DC-0401-1203002, DC-0401-1203003)
and verification studies batch analysis and
product.
Pharmaceutical equivalence and against Estar 5mg tablet by M/s Pharmevo,
comparative dissolution profile Pvt Ltd (Batch No 1M031) Quality
parameters such as identification, dissolution
and assay were compared against Expel 5mg
Tablet (Batch No TB-01-E5)

brand that is Estar 5mg tablet by M/s
Pharmevo, Pvt Ltd (Batch No 1M031) in
range.
CDP report is not submitted

of product

Manufacturer of API Zhejiang Haisen Pharmaceutical Co Ltd China
API Lot No. 3621050212
Description of Pack
system)
Strength 5mg Tablet
No. of Batches 03
firm (if any)
Approval of API/ DML/GMP certificate of Not submitted

import).
chromatograms,
sheets etc.
testing
accelerated)

01.11.2022)
Valid Good Manufacturing Practice (GMP) Firm has provided copy of GMP
certificate of the Drug Substance / API certificate (No. ZJ20190082)
manufacturer issued by concerned issuance dated 22.07.2019 valid till
regulatory authority of country of origin to 21.07.2024 by China Food and
be provided Drug Administration.
GMP status/inspection report of FPP Inspection report for grant of
manufacturer to be submitted. DML has been provided (dated
24.08.2021)
Provide results of analysis of relevant Complied.
batch(es) of Drug Substance performed by
Drug Product manufacturer used during .
product development and stability studies,
along with Certificate of Analysis (COA)
of the same batch from Drug Substance /
API manufacture.
Detailed analytical procedures for the Complied.

Analytical Method Verification studies Complied.
provided
Specifications of primary / secondary Firm has submitted copy of CoA of
reference standard including source and lot working standard (Escitalopram
number for primary reference standard to oxalate, batch no. WS-3621)
be provided
For testing of Pharmacopoeial Drug
Substance, the use of primary
reference standard is recommended,
use of working standard to be
justified.
Stability data of Drug Substance has been complied.
Real time stability data submitted
for three batches: (3619102201,
3619102202 3619102203) for the
period of 24 months at 30.°C ± 2°C
/ 75% ± 5%RH.
Detailed CDP report to be provided Firm has submitted CDP report now
wherein values for f1 and f2 are calculated Wherein CDP has been performed
along with results conclusion. as follows:
Reference Product
M/s M/s
PharmEvo Akhsah
Expel
Brand Estar 5mg
5mg
name tablet
tablet
Batch TB-01-
1M031
No. E5
mediums:
acceptable range.
finished product specification and stability of dose for all three stability batches
studies. TB-01-E5, TB-02-E5, TB-03-E5
with approval from DRAP is required invoice (Invoice# ZHP8220126
received quantity i.e. 0.3Kg) for the
purchase of Escitalopram oxalate
from Zhejiang Haisen
Pharmaceutical Co Ltd China with
attestation of DRAP dated
02/03/2022
Decision: Approved

estate, Rawat
estate, Rawat
☒ Manufacturer
☐ Importer
giver)
☐Domestic sale
09/09/2022
Expel 10mg Tablet
name
Active Pharmaceutical ingredient (API) Escitalopram Oxalate eq. to
per unit Escitalopram………………….……..….10mg
Pharmacotherapeutic Group of (API) Anti-depressant
USP specification
specifications
USFDA approved
authorities
For generic drugs (me-too status) Estar 10mg tablet by M/s Pharmevo, Karachi
DML grant inspection report not submitted
Tablet section (General) is approved dated
manufacturer
14.09.2021
Name and address of API manufacturer. Zhejiang Haisen Pharmaceutical Co Ltd
and justification of specification, control of
excipients, list of reference standard used,
of drug substance and drug product is
submitted.
months
Stability studies
months
Batches: (3619102201, 3619102202
3619102203)
DC-0401-1203002, DC-0401-1203003)
and verification studies batch analysis and
product.
against Estar 10mg tablet by M/s pharmevo,
Pvt Ltd (Batch No 1G016) Quality parameters
such as identification, dissolution and assay
were compared against Expel 10mg Tablet
(Batch No TB-01-E10)
Pharmaceutical equivalence and CDP has been performed against the same
comparative dissolution profile brand that is Estar 10mg tablet by M/s
Pharmevo, Pvt Ltd (Batch No 1G016) in
range.
CDP report is not submitted

of product
specificity.

Manufacturer of API Zhejiang Haisen Pharmaceutical Co Ltd China
API Lot No. 3621050212
Description of Pack
system)
Strength 10mg Tablet
No. of Batches 03
the firm (if any)
Approval of API/ DML/GMP certificate Not submitted

import).

sheets etc.
testing
accelerated)

Valid Good Manufacturing Practice (GMP) Firm has provided copy of GMP
certificate of the Drug Substance / API certificate (No. ZJ20190082)
manufacturer issued by concerned issuance dated 22.07.2019 valid till
regulatory authority of country of origin to 21.07.2024 by China Food and
be provided Drug Administration.
GMP status/inspection report of FPP Inspection report for grant of
manufacturer to be submitted. DML has been provided (dated
24.08.2021)
Provide results of analysis of relevant complied.
batch(es) of Drug Substance performed by
Drug Product manufacturer used during
product development and stability studies,
along with Certificate of Analysis (COA)
of the same batch from Drug Substance /
API manufacture.
Detailed analytical procedures for the complied.

Analytical Method Verification studies complied.
provided
Specifications of primary / secondary Firm has submitted copy of CoA of
reference standard including source and lot working standard (Escitalopram
number for primary reference standard to oxalate, batch no. WS-3621)
be provided
For testing of Pharmacopoeial Drug
Substance, the use of primary
reference standard is recommended,
use of working standard to be
justified.
Stability data of Drug Substance has been complied.
Real time stability data submitted
for three batches: (3619102201,
3619102202 3619102203) for the
period of 24 months at 30°C ± 2°C /
75% ± 5%RH.
Detailed CDP report to be provided Firm has submitted CDP report now
wherein values for f1 and f2 are calculated Wherein CDP has been performed
along with results conclusion. as follows:
Reference Product
M/s M/s
PharmEvo Akhsah
Brand Estar 10mg Expel 10
name tablet mg tablet
Batch TB-01-
1G016
No. E10
mediums:
acceptable range.
finished product specification and stability of dose for all three stability batches
studies. TB-01-E10, TB-02-E10, TB-03-
E10
with approval from DRAP is required invoice (Invoice# ZHP8220126
received quantity i.e. 0.3Kg) for the
purchase of Escitalopram oxalate
from Zhejiang Haisen
Pharmaceutical Co Ltd China with
attestation of DRAP dated
02/03/2022
Decision: Approved
Registration applications of newly granted DML or New section (Human)

New Section:
M/s Hudson Pharma (Pvt) Limited D-93, North West Industrial zone , Port Qasim Karachi
CLB in its 283rd meeting held on 28th October 2021, has considered and approved the grant of
following additional sections/facility:
• Injectable ampoule BF (Steroid)-New

• Capsule Section (General)-New
386. M/s Hudson Pharma (Pvt) Limited D-93,

Name, address of Applicant /
North West Industrial zone , Port Qasim
Karachi
M/s Hudson Pharma (Pvt) Limited D-93,
Name, address of Manufacturing site. North West Industrial zone , Port Qasim
Karachi
☒ Manufacturer
☐ Importer
(contract giver)
☒ New Drug Product (NDP)
☐Domestic sale
Intended use of pharmaceutical
☐ Export sale
product
23/09/2022
The proposed proprietary name / brand Actonide Suspension for Nebulisation
name 1mg/2ml
Strength / concentration of drug of Each 2 ml Respule contains:
Active Pharmaceutical ingredient Budesonide…….1mg
(API) per unit
Pharmaceutical form of applied drug Suspension for inhalation
Pharmacotherapeutic Group of (API) Corticosteroid
BP specification
specifications
Proposed Pack size 1mg/2ml (2mlx10’s)
MHRA approved
The status in reference regulatory Pulmicort Inhalation Suspension 1mg/2ml
authorities (Manufacturer: AstraZeneca)
For generic drugs (me-too status) Not Available

GMP inspection conducted on 07th October
GMP status of the Finished product 2021
manufacturer Additional section Injectable ampoule BF
(Steroid) approved on 24.11.2021
Name and address of API Industriale Chimica S.R.L Via E.H
manufacturer. Grieg,13-21047 SARONNO (VA)
control of excipients, list of reference
standard used, container closure system and
Module III (Drug Substance) controls, tests for impurity A, D, K, L &
related substances specifications, batch
years.
Stability studies
for 6 months
Batches: (080377, 080488, 080492)
analytical procedure and verification
studies batch analysis and justification of
determined against Pulmicort 1mg/2ml
inhalation suspension by Astrazeneca
Pharmaceutical equivalence and (Batch No PBLF) Quality parameters such
comparative dissolution profile as identification, Ph, Epimer A and assay
were compared against Actonide
Suspension for Nebulisation 1mg/2ml
(Batch No SB-BU-NU-01)
Analytical method

Manufacturer of API Industriale Chimica S.R.L Via E.H Grieg,13-21047 SARONNO
(VA)
API Lot No. PR182023
Description of Pack
LDPE ampoule
Strength 1mg/2ml
Batch No. SB-BU-NU-01 SB-BU-NU-02 SB-BU-NU-03
No. of Batches 03
Reference of previous approval of Firm has referred to onsite inspection
applications with stability study data of report of their product for Brinzoson eye
the firm (if any) drops (dated 08th October, 2020). Further,
the said panel inspection report was
meeting held on 12th – 15th January 2021.
The case was approved and the inspection
report confirms following points:
available for stability chamber. Chambers
are controlled and monitored through data
logger..
personnel and utilities are GMP compliant
Approval of API/ DML/GMP GMP certificate of Industriale Chimica
certificate of API manufacturer issued S.R.L Via E.H Grieg,13-21047 SARONNO
by concerned regulatory authority of (VA) based on inspection conducted on
country of origin. 21.09.2018 (valid till 3 years) by AIFA.
with approval from DRAP (in case of 0567/19 DRAP dated 21-02-2019
import). confirming import of 0.39Kg Budesonide
micronised from M/s Industriale Chimica
S.R.L for Batch No. PR182023
Budesonide
Batch No. Date Invoice Quantity
of No. Import
import
PR182023 20-02- CS- 0.390Kg
2019 19/01540
supported by attested respective Water loss test was also performed for semi
documents like chromatograms, permeable container closure system, which
Raw data sheets, COA, summary data was found within acceptable range.
sheets etc.
testing
accelerated)
Valid Good Manufacturing Practice Firm has referred to notice from
(GMP) certificate of the Drug Substance / EMA regarding MEDICINAL
API manufacturer issued by concerned PRODUCTS FOR HUMAN USE
regulatory authority of country of origin to DURING THE COVID-19
be provided PANDEMIC wherein it is written
that:
The validity of GMP certificates
for manufacturing sites of active
substances and/or finished products
located outside the EEA should be
extended until the end of 2023
without the need for further action
from the holder of the certificate,
Specifications of primary / secondary Specifications of Budesonide
reference standard including source and Working standard (internal code A-
lot number for primary reference standard 3736) from INDUSTRIALE
to be provided
CHIMICA Srl Via E.H. Grieg 13,
Saronno are provided.
For testing of Pharmacopoeial Drug Budesonide Working Standard (A-
Substance, the use of primary reference 3736) is identified by comparison
standard is recommended, justify use of of its IR spectrum with those
working standard for Budesonide obtained from Standard supplied by
Pharmacopoeia European (batch
4,0, internal code A-3769). The
obtained spectra are perfectly
identical and superimposable.
Decision: Approved
M/s Caraway Pharmaceuticals, RCCI Rawat, Islamabad.

CLB in its 287th meeting held on 24th June 2022, has considered and approved the renewal of DML
of already approved section. Moreover, following amendment has been approved:
Liquid vial section(infusion) changed into syrup on first floor
387. Name, address of Applicant / Marketing M/s Caraway Pharmaceuticals, RCCI Rawat,
Authorization Holder Islamabad.
Name, address of Manufacturing site. M/s Caraway Pharmaceuticals, Plot 12, Street
N-3 RCCI Rawat Islamabad
☐ Importer
giver)
☐ Export sale
Dy. No. and date of submission Dy. No. 27124 dated 20 /09/2022
Licide Syrup 2.5mg/5mL
name
Strength / concentration of drug of Each 5mL contains;
Active Pharmaceutical ingredient (API) Levocetirizine Dihydrochloride ……2.5mg
per unit
Pharmaceutical form of applied drug Syrup
Pharmacotherapeutic Group of (API) Anti-histaminic (Piperazine derivative)
specifications
The status in reference regulatory XYZAL oral solution 2.5/5mL
For generic drugs (me-too status) Concidol L Syrup by M/s Convell
Laboratories Registration No. 079350
GMP status of the Finished product Last inspection conducted on 22-02-2022
manufacturer Syrup section approved on 04.07.2022
Name and address of API manufacturer. M/s Metrochem API Private Limited India
Module III (Drug Substance) Official monograph of Levocetirizine
Dihydrochloride is present in USP. The firm
as submitted detail of nomenclature,
impurity related substances, specifications,
substance
Real time: 25°C ± 2°C / 65% ± 5% RH for 60
months.
6 months Batches:(LCZ/A/200801001,
LCZ/A/200801002,LCZ/A/200801003)
analytical procedure its verification studies,
product.
T-Day syrup by GSK Pakistan by performing
quality tests (Physical Appearance,
Identification pH, Volume & Assay).
validation/verification of product including linearity, range, accuracy,
Manufacturer of API M/s Metrochem API Private Limited India
API Lot No. LVHPC20280
Description of Pack
Amber color PET bottle (60ml) packed in unit carton (1’s)
Stability Storage Condition Real time: 30°C ± 2°C / 65% ± 5%RH for 24 months
Frequency Accelerated: 0,3, 6 (Months)
Batch No. T-031 T-032 T-033

No. of Batches 03
Reference of previous approval of Not provided
the firm (if any)
Approval of API/ DML/GMP certificate Copy of GMP certificate No. .
of API manufacturer issued by concerned L.Dis.No.HMF07-14051/305/2020-TECH-
regulatory authority of country of origin. DCA Dated:18.08.2020 issued by Govt of
Andhra Pradesh DCA valid up to three years
Documents for the procurement of API Levocetirizine Dihydrochloride invoice no.
with approval from DRAP (in case of DE/20/104 Dated:31.10.2020
import). is attached as proof of procurement of API
(10Kg) Batch No LVHPC20280 from
Metrochem API Pvt. Ltd India.
Data of stability batches will be The firm has submitted Data of stability
supported by attested respective batches supported by attested respective
documents like chromatograms, documents like chromatograms, raw data
Raw data sheets, COA, summary data sheets, COA, summary data sheets etc.
sheets etc.
Compliance Record of HPLC software The firm has submitted Compliance Record
21CFR & audit trail reports on product of HPLC software 21CFR & audit trail
testing reports on product testing.
Record of Digital data logger for The firm has submitted Record of Digital data
stability chambers (real time and monitoring of stability chambers (real time
accelerated) and accelerated).
Formulation approved in RRA is mentioned as Firm has revised dosage
“oral solution” while dosage form mentioned by form as per RRA (from syrup to
the firm in instant application is “syrup” hence oral solution) without fee.
dosage form should be standardized on line with
RRA along with fee.
Stability data (real time) of Drug Substance has Firm has submitted stability data
been submitted with 25°C ± 2°C / 65% ± 5% RH of drug substance as per zone
condition which is not as per WHO zone IV-A. IV-A conditions as follows:
Submit real time stability study data of drug Batch No: LVU-P/19001
substance as per zone IV-A or else submit the LVU-P/19002
following as per the decision of 290th meeting of LVU-P/19003
Registration Board: 40°C ± 2°C / 75% ± 5% RH for
Record of data logger for the storage conditions 36 months
throughout the transportation. 30°C ± 2°C / 65% ± 5% RH for
Real term stability studies data of the product for 36months
at least 1 year along with degradation studies in
the finished pharmaceutical product
Proposed container closure system (PET) Firm has submitted suitability

suitability testing to be submitted as per testing of PET bottle as per USP
pharmacopeia. Moreover, description is required general monograph <661>
regarding suitability of the container closure
system for the storage, transportation (shipping) Including thermal analysis,
and use of the FPP (e.g. choice of materials, heavy metals testing and IR
protection from moisture and light, compatibility spectroscopic analysis.
of the materials with the FPP)
Documents for the procurement of API with Not complied

approval from DRAP is required. Only
commercial invoices are provided under this Firm has again submitted invoice
section. no. DE/20/104
Dated:31.10.2020
is attached as proof of
procurement of API (10Kg)
Batch No LVHPC20280 from
Metrochem API Pvt. Ltd India.
Approval from DRAP is

required.
For testing of Pharmacopeial Drug Substance, Firm has submitted USP
the use of primary reference standard is reference standard of
recommended, justify use of working standard Levocetirizine Dihydrochloride
for Levocetirizine Dihydrochloride. 200mg (lot No R170Q0) which
is used in API testing and for
batch release.
Compatibility of the Drug Substance(s) with Firm has submitted

excipients is not provided (mainly alpha compatibility testing of alpha
tocopherol and mannitol) which are not used in tocopherol and mannitol with
reference product. drug substance using HPLC
method. There was no significant
change in % quantity of drug at
storage condition 60°C ± 2°C
Reference of previous approval of applications Not provided
• DRAP clearance certificate of drug substance (Levocetirizine Dihydrochloride) along
with commercial invoice, CoA (from both Drug Substance/Drug Product
manufacturer) of relevant batch no. is required
• Submission of applicable fee that is Rs. 7,500/- for revision of dosage form (from
syrup to oral solution) as per notification No.F.7-11/2021-B&A/DRAP dated 13-07-
2021
Item No. X: Agenda of Evaluator (Dr. Sidra Khalid)
388. Name, address of Applicant / M/s Getz Pharma (Pvt.) Limited

Marketing Authorization Holder 29-30/27, Korangi Industrial Area, Karachi.
☐ Importer
giver)
☐ Export sale
Nalbim Injection 10mg/ml
name
Strength / concentration of drug of Each 1ml ampoule contains:
Active Pharmaceutical ingredient Nalbuphine HCl …….10mg
(API) per unit
Pharmaceutical form of applied drug Clear, colourless liquid free from foreign particles
filled in clear glass ampoule USP further packed in
secondary carton.
Pharmacotherapeutic Group of (API) Morphinan derivatives
Getz Pharma Specs.
specifications
Proposed Pack size 1ml x 1’s, 1ml x 5’s & 1ml x 10’s
Proposed unit price Rs. 100/- (1ml x 1’s)
Rs. 500/- (1ml x 5’s)
Rs. 1000/- (1ml x 10’s)
The status in reference regulatory Nalbuphine HCl Injection 10mg/ml by M/s
authorities Hospira, Inc., USA. USFDA Approved.
For generic drugs (me-too status) Kinz Injection 10mg/ml by M/s SAMI
Pharmaceutical (Pvt.) Ltd, Karachi.
(Reg. No. 018686)
GMP status of the Finished product Last GMP Inspection dated 03-12-2021
manufacturer concludes that M/s Getz Pharma Pvt. Ltd. is
considered to be operating at an acceptable level
of compliance of GMP requirements. Liquid
Injectable (General) section approved.
Name and address of API SpecGx LLC
manufacturer. 3600 North Second Street St. Louis, Missouri
63147. USA
procedures and its Validation, batch analysis and
Module III (Drug Substance) Official monograph of Nalbuphine HCl is not
present in any pharmacopeia. The firm has
substance.
months
months
Batches: (0907000789, 0907000790,
0907000791)
comparative dissolution profile established against the brand leader that is Kinz
Injection 10mg/ml by M/s SAMI Pharmaceutical
(Pvt.) Ltd, by performing quality tests
(Appearance, Assay, pH and deliverable volume).
CDP is not applicable.
Analytical method Method Validation studies have submitted
validation/verification of product including system suitability, specificity, linearity,
accuracy, precision, robustness, stability of
solution and range.
Manufacturer of API SpecGx LLC
3600 North Second Street St. Louis, Missouri 63147. USA
API Lot No. 2002000117
Description of Pack Clear glass USP ampoule, packed in unit carton with packaging insert.
(Container closure system) (1ml x 1’s, 1ml x 5’s & 1ml x 10’s).
Real Time: 0, 3, 6, 9 (Months)
Batch No. 564DS01 565DS02 566DS03
No. of Batches 03
applications with stability study data of their product for Estine (Ebastine) Tablets 10mg
the firm (if any) & 20mg on 6th May, 2019. Further, the said panel
Registration Board meeting held on 14th – 16th
May 2019. The case was approved and the
for alerts as well.
Approval of API/ DML/GMP API manufacturer of Nalbuphine HCl that is
certificate of API manufacturer issued SpecGx LLC is USFDA approved source and
by concerned regulatory authority of validity of their site registration is till 31/12/2022.
country of origin.
Link for FDA Inspection Classification Database
is as follows:
https://datadashboard.fda.gov/ora/cd/inspections.h
tm
Documents for the procurement of API Copy of commercial invoice attested by AD I&E
with approval from DRAP (in case of DRAP, Karachi, has been submitted.
import). Date of
Batch Invoice Quantity approval
No. No. Imported by
DRAP
2002000 190271 0.5000 03-11-
117 01 Kg 2020
Data of stability batches will be Firm has submitted data of stability batches along
supported by attested respective with batch manufacturing record, analytical
documents like chromatograms, Raw record and attested documents like
data sheets, COA, summary data sheets chromatograms, Raw data sheets, COA, summary
etc. data sheets etc.
Compliance Record of HPLC software Firm has submitted compliance certificate of
21CFR & audit trail reports on product HPLC software and audit trail reports on product
testing testing.
Record of Digital data logger for
Firm has submitted Record of Digital data logger
for temperature & humidity monitoring of
stability chambers (real time and accelerated).
accelerated)
S No Section #. Deficiencies Reply

3.2.S.4.3 Submit data of verification of Analytical Method
analytical procedure of drug Verification studies
substance as per the guidance including system suitability,
document approved by specificity, linearity,
Registration Board which repeatability and range
specifies that “Analytical Method performed by the Drug
Verification studies including Product manufacturer.
specificity, accuracy and Further, with reference to
repeatability (method precision) ICH Guidelines
performed by the Drug Product “VALIDATION OF
manufacturer for both ANALYTICAL
compendial as well as PROCEDURES: TEXT
noncompendial drug substance(s) AND METHODOLOGY
shall be submitted” Q2 (R1)” it is mentioned in
section 4.1.1 Drug
Substance “accuracy may
be inferred once precision,
linearity and specificity
have been established”. This
is bring to your kind
attention that since we have
performed method
verification studies as per
ICH Q2 (R1) therefore,
requirement of accuracy is
not applicable.
3.2.S.4.2 Justify how the developed This is to inform you that
formulation is declared similar in our benchmark innovator
quality with the comparator product (for both strength)
product since the values of pH is NUBAIN Injection by
(3.00-4.5)are outside the M/s Par Pharmaceutical
acceptable limit defined by FDA USA, which is USFDA
approved innovator product. approved product.
The pH values as mentioned
in prescribing information
of NUBAIN Injection range
is 3.5 – 3.7 which is target
pH value. However, pH
ranges as provided by
NUBAIN Injection is 3.0 –
4.5 as mentioned in Rx list
of NUBAIN Injection and
prescribing information of
Nalbuphine Injection by
M/s Hospira Inc. USA.
This is to bring to your kind
attention that NUBAIN
Solution for Injection as
approved by Austrian
Agency for Health and Food
Safety has mentioned pH
value range of 3.0 – 4.0 in
their approved prescribing
information.
attention that Lapainol
approved by Health
Products Regulatory
Authority (HPRA) Ireland
has mentioned pH value
range of 3.0 – 4.2 in their
approved prescribing
information.
3.2.P Provide results of analysis of Results of analysis of
relevant batch(es) of Drug relevant batch (es) of Drug
Substance performed by Drug Substance performed by
Product manufacturer used Drug Product manufacturer
during product development and used during product
stability studies, along with development and stability
Certificate of Analysis (CoA) of studies, along with
the same batch from Drug Certificate of Analysis
Substance /Active (CoA) of the same batch
Pharmaceutical Ingredient from Drug Substance
manufacture Active Pharmaceutical
Ingredient manufacture is
provided
3.2.S.4 The excipients are different from
This is to inform you that
the reference product our benchmark innovator
justification is needed in this product (for both strength)
regard is NUBAIN Injection by
M/s Par Pharmaceutical
USA, which is USFDA
approved product.
We have developed the
formulation for our product
& Nalbim Injection
20mg/ml by using the same
excipients as used in
benchmark product.
The Name of manufacture is SpecGx LLC and
mentioned as SpecGx LLC 3600 Mallinckrodt's are same
North Second Street St. Louis, entity. Mallinckrodt's
Missouri 63147. USA but on all Specialty Generics and API
documents, name is mentioned as business' changed their legal
Mallinckrodt pharmaceuticals. name to SpecGx LLC in
Provide the relationship. 2017. The manufacturer
declares that “The
Mallinckrodt logo and trade
names will remain on all
product labels”.
Decision: Approved
389. Name, address of Applicant / M/s Getz Pharma (Pvt.) Limited

Marketing Authorization Holder 29-30/27, Korangi Industrial Area, Karachi.
☐ Importer
giver)
☐ Export sale
name
Strength / concentration of drug of Each 1ml ampoule contains:
Active Pharmaceutical ingredient Nalbuphine HCl…….20mg
(API) per unit
Pharmaceutical form of applied drug Clear, colorless liquid free from foreign particles
filled in clear glass ampoule USP further packed
in secondary carton.
Pharmacotherapeutic Group of (API) Morphinan derivatives
Getz Pharma Specs.
specifications
Proposed Pack size 1ml x 1’s, 1ml x 5’s & 1ml x 10’s
Proposed unit price Rs. 150/- (1ml x 1’s)
Rs. 750/- (1ml x 5’s)
Rs. 1500/- (1ml x 10’s)
The status in reference regulatory Nalbuphine HCl Injection 20mg/ml by M/s
authorities Hospira, Inc., USA. USFDA Approved.
For generic drugs (me-too status) Kinz Injection 20mg/ml by M/s SAMI
Pharmaceutical (Pvt.) Ltd, Karachi.
(Reg. No. 018687)
GMP status of the Finished product Last GMP Inspection dated 03-12-2021
manufacturer concludes that M/s Getz Pharma Pvt. Ltd. is
considered to be operating at an acceptable level
of compliance of GMP requirements. Liquid
Injectable (General) section approved.
Name and address of API SpecGx LLC
manufacturer. 3600 North Second Street St. Louis, Missouri
63147. USA
procedures and its Validation, batch analysis and
Module III (Drug Substance) Official monograph of Nalbuphine HCl is not
present in any pharmacopeia. The firm has
substance.
months
months
Batches: (0907000789, 0907000790,
0907000791)
comparative dissolution profile established against the brand leader that is Kinz
Injection 20mg/ml by M/s SAMI Pharmaceutical
(Pvt.) Ltd, by performing quality tests
(Appearance, Assay, pH and deliverable volume).
CDP is not applicable.
Analytical method Method Validation studies have submitted
validation/verification of product including system suitability, specificity, linearity,
accuracy, precision, robustness, stability of
solution and range.
Manufacturer of API SpecGx LLC
3600 North Second Street St. Louis, Missouri 63147. USA
API Lot No. 2002000117
Description of Pack Clear glass USP ampoule, packed in unit carton with packaging insert.
(Container closure system) (1ml x 1’s, 1ml x 5’s & 1ml x 10’s)
Real Time: 0, 3, 6, 9 (Months)
Batch No. 565DS01 565DS02 565DS03
No. of Batches 03
applications with stability study data of their product for Estine (Ebastine) Tablets 20mg
the firm (if any) & 20mg on 6th May, 2019. Further, the said panel
Registration Board meeting held on 14th – 16th
May 2019. The case was approved and the
for alerts as well.
Approval of API/ DML/GMP API manufacturer of Nalbuphine HCl that is
certificate of API manufacturer issued SpecGx LLC is a USFDA approved source and
by concerned regulatory authority of validity of their site registration is till 31/12/2022.
country of origin.
Link for FDA Inspection Classification Database
is as follows:
https://datadashboard.fda.gov/ora/cd/inspections.h
tm
Documents for the procurement of API Copy of commercial invoice attested by ADI&E
with approval from DRAP (in case of DRAP, Karachi, has been submitted.
import). Date of
Batch Invoice Quantity approval
No. No. Imported by
DRAP
2002000 190271 0.5000 03-11-
117 01 Kg 2020
Data of stability batches will be Firm has submitted data of stability batches along
supported by attested respective with batch manufacturing record, analytical
documents like chromatograms, Raw record and attested documents like
data sheets, COA, summary data sheets chromatograms, Raw data sheets, COA, summary
etc. data sheets etc.
Compliance Record of HPLC software Firm has submitted compliance certificate of
21CFR & audit trail reports on product HPLC software and audit trail reports on product
testing testing.
Firm has submitted Record of Digital data logger
for temperature & humidity monitoring of
accelerated)
S No Section #. Deficiencies Reply

3.2.S.4.3 Submit data of verification of Analytical Method
analytical procedure of drug Verification studies
substance as per the guidance including system suitability,
document approved by specificity, linearity,
Registration Board which repeatability and range
specifies that “Analytical Method performed by the Drug
Verification studies including Product manufacturer.
specificity, accuracy and Further, with reference to
repeatability (method precision) ICH Guidelines
performed by the Drug Product “VALIDATION OF
manufacturer for both ANALYTICAL
compendial as well as PROCEDURES: TEXT
noncompendial drug substance(s) AND METHODOLOGY
shall be submitted” Q2 (R1)” it is mentioned in
section 4.1.1 Drug
Substance “accuracy may
be inferred once precision,
linearity and specificity
have been established”. This
is bring to your kind
attention that since we have
performed method
verification studies as per
ICH Q2 (R1) therefore,
requirement of accuracy is
not applicable.
3.2.S.4.2 Justify how the developed This is to inform you that
formulation is declared similar in our benchmark innovator
quality with the comparator product (for both strength)
product since the values of pH is NUBAIN Injection by
(3.00-4.5) are outside the M/s Par Pharmaceutical
acceptable limit defined by FDA USA, which is USFDA
approved innovator product. approved product.
The pH values as mentioned
in prescribing information
of NUBAIN Injection range
is 3.5 – 3.7 which is target
pH value. However, pH
ranges as provided by
NUBAIN Injection is 3.0 –
4.5 as mentioned in Rx list
of NUBAIN Injection and
prescribing information of
Nalbuphine Injection by
M/s Hospira Inc. USA.
attention that NUBAIN
approved by Austrian
Agency for Health and Food
Safety has mentioned pH
value range of 3.0 – 4.0 in
their approved prescribing
information.
attention that Lapainol
approved by Health
Products Regulatory
Authority (HPRA) Ireland
has mentioned pH value
range of 3.0 – 4.2 in their
approved prescribing
information.
3.2.P Provide results of analysis of Results of analysis of

relevant batch(es) of Drug relevant batch (es) of Drug
Substance performed by Drug Substance performed by
Product manufacturer used Drug Product manufacturer
during product development and used during product deve
stability studies, along with lopment and stability
Certificate of Analysis (CoA) of studies, along with
the same batch from Drug Certificate of Analysis
Substance /Active (CoA) of the same batch
Pharmaceutical Ingredient from Drug Substance
manufacture Active Pharmaceutical
Ingredient manufacture is
provided
3.2.S.4 The excipients are different from This is to inform you that
the reference product our benchmark innovator
justification is needed in this product (for both strength)
regard is NUBAIN Injection by
M/s Par Pharmaceutical
USA, which is USFDA
approved product.
We have developed the
formulation for our product
& Nalbim Injection
20mg/ml by using the same
excipients as used in
benchmark product.
The Name of manufacture is SpecGx LLC and
mentioned as SpecGx LLC 3600 Mallinckrodt's are same
North Second Street St. Louis, entity. Mallinckrodt's
Missouri 63147. USA but on all Specialty Generics and API
documents, name is mentioned as business' changed their legal
Mallinckrodt pharmaceuticals. name to SpecGx LLC in
Provide the relationship. 2017. The manufacturer
declares that “The
Mallinckrodt logo and trade
names will remain on all
product labels”.
Decision: Approved
• Manufacturer will place first three production batches on long term
stability studies throughout proposed shelf life and on accelerated studies
for six months as per the commitment submitted in the registration
application.
• Manufacturer will perform process validation of first three batches as per
the commitment submitted in the registration application
Priority Registration applications of Export Facilitation

Assistant Director PR-I/EFD vide letter NO.1-6/2019-PR-I (EFD) dated 18-06-2021 has informed that
Reg. Board in its 263rd meeting held on 29-30th November 2016 decided to grant registration on
priority basis to the pharmaceutical firms/manufacturers who have shown appreciable performance in
export of pharmaceuticals. The Board further decided to consider one molecule for each 50,000 USD
worth of export of medicines (to a maximum of 15 such molecules) during a fiscal year. In compliance
to the aforementioned decision of the Board, the following firms have achieved the benchmark of USD
656,218.90/- during FY 2020-21. Following applications submitted by the firms for priority
consideration/ evaluation in lieu of export facilitation are submitted before the Board for its
consideration please:
Name and address of manufacturer / M/s. Nabiqasim Industries (Pvt). Ltd., 17/24,
390. Applicant Korangi Industrial Area, Karachi
Brand Name +Dosage Form + Redupres-S 49/51 mg Tablet
Strength
Sacubitril……..48.6 mg
Valsartan…..…51.4 mg
(as sacubitril valsartan sodium salt complex).
Dated 13-12-2017
Pharmacological Group Angiotensin II receptor blocker
Pack size & Demanded Price 10’s, 14‟s As per SRO
Approval status of product in Entresto™ (sacubitril/valsartan) Tablets,
Reference Regulator Authorities 97/103, 49/51, and 24/26 mg (USFDA)
Me-too status NA
GMP status 03.08.2017, The firm is operating at an
acceptable level of compliance of GMP
requirements at the time of inspection.
Remarks of the Evaluator Assay is by HPLC method
The firm didn’t provide detailed dissolution
method, 2ndly It shall justify the dissolution
specification NLT 80%(Q) after 45 minutes,
since the USFDA review document of the
innovator product specify dissolution
specifications i.e NLT (Q) after 25 minutes.
Revise the dissolution specifications to NLT
(Q after 25 minutes as per the reference product
and as per the decision of 293rd meeting of
Registration Board.
GMP certificate by API manufacturer Not
provided by Guangdong Province. But the city
Reference and working standard missing

Drug Redupres-S 49/51 mg Tablet
Name of Manufacturer M/s. Nabiqasim Industries (Pvt). Ltd., 17/24, Korangi
Manufacturer of API sacubitril/valsartan: M/s Zhuhai Rundu Pharmaceutical Co.,
Ltd, China
Address: No 6,North airport Road Sanzao Town, Jinwan
District Zhuhai, Guangdong province China
API Lot No. sacubitril/valsartan: 57318060103
Description of Pack
As per SRO
Accelerated: 40 °C ± 2 °C/75% ± 5%
Accelerated:6 months
Frequency Accelerated: 0,1,2,3,4, 6 (month)
Batch No. 375DS01 375DS02 375DS03
Batch Size 1500 1500 1500
No. of Batches 03
Date of Submission 2/June/2021 (15245)
Reference of previous approval of A panel inspection of Sofosbuvir 400 mg
applications with stability study data of the tablet conducted on 26th October 2020
firm and approved in 297 meeting. Audit trail
on the testing reports cannot be made as
audit trail was not activated.
Certificate of Analysis of API from both For Sacubitral/Valsartin:
API Manufacturer and Finished Product The firm has submitted COA from both
manufacturer. API Zhuhai Rundu Pharmaceutical Co.
Ltd China No.6, North Airport Road,
Sanzao Town, Jinwan District,
Guangdong, China and FPP manufacturer
API Manufacturer and Finished Product Yes
Manufacturer
Stability study data of API from API
Provided (for zone IV-B)
manufacturer
Approval of API/ DML/GMP certificate of Sacubitril/Valsartan:
API manufacturer issued by concerned The firm has provided copy of Certificate
regulatory authority of country of origin. of GMP compliance issued to M/s Zhuhai
food and Drug administration, valid Up to
21-12-2021.
Not provided by Guangdong Province.
Documents for the procurement of API with Sacubitril/Valsartan:
approval from DRAP (in case of import). Copy of commercial invoice has been
submitted issued by ADC, Karachi DRAP.
Import quantity: 3.3 kg
Impurities: Provided
Address of Exporter (Head office): M/s
Zhuhai Rundu Pharmaceutical Co. Ltd
China No.6, North Airport Road,Sanzao
Town, Jinwan District, Guangdong, China
Yes
stability study
Method used for analysis of FPP Yes (same as API manufacturer)
Drug-excipients compatibility studies NA
Brand)
Complete batch manufacturing record of
The firm has submitted photocopy of
Batch Manufacturing Orders of following
03 Batches:
375DS01 1500 10-2020

10-2020
375DS02 1500
375DS03 1500 10-2020
Record of comparative dissolution data Firm has submitted Comparative

(where applicable) dissolution study of their product with
Innovator’s Brand “Uperio 100 mg
Tablets” The details are as follows:
Reference Test Product
product
Produ Uperio Produc Sacubitr
ct 100 mg t name il/Valsar
name Tablets tan
tablet
Batch TEJ85 Batch 375DS0
# # 1
Mfg 05-2019 Mfg 10-2020
date date

Yes
Compliance Record of HPLC software
testing.
Submitted
accelerated)
Sr. Observations/Documents Required Status of Document/Justifications
No.
specification NLT 80% (Q) after 45 minutes,
since the USFDA review document of the The revise Finished Product
innovator product specify dissolution Specification as per the reference
1.
specifications i.e. NLT (Q) after 25 minutes. product is submitted without
Revise the dissolution specifications to NLT submission of any fee
(Q) after 25 minutes as per the reference
product as per the decision of 293rd meeting of
Registration Board.
The valid GMP Certificate of API
Submitted GMP Certificate of supplier of API
Manufacturer M/s. Zhuhai Rundu
has been issued by M/s. Zhuhai Food and Drug
Pharmaceutical Co. Ltd., (Vali till
2. Administration, instead of Provincial Drug
13-11-2021) issued by the China
Regulatory Authority. Clarification is required
Food and Drug Administration is
for this regard.
provided
Firm has not submitted documents for The documents for procurement of
3. procurement of reference and impurity reference and impurity standards
standards. is provided
The valid DML # 000105 (by way
Valid DML of FPP should be provided as of formulation) renewed w.e.f. 12-
4.
provided one is expired. 07-2019 and valid upto 11-07-
2024 is attached
In Reference of previous approval of We in this regard would like to
application with stability study data firm state that our latest GMP
provides the panel inspection of Sofosbuvir Inspection report carried out by
400 mg tablet conducted on 26th October 2020 the DRAP Panel for our new drug
and approved in 297 meeting but the Audit trail “Novasept 7.1% Gel” on 27th
of the testing reports cannot be made as audit October 2020 (Report enclosed
trail was not activated. So, on that base herewith) confirms the availability
exemption could be granted. of audit trials on the testing report.
Copy of Inspection Report of
Novasept Gel is product
We are also enclosing Firm has
Comparative Dissolution Profile. submitted Comparative
dissolution study of their product
100 mg Tablets” The details are as
follows:
product
Pro Uperio Prod Sacubi
duct 100 uct tril/Va
nam mg name lsartan
e Tablet tablet
s
Bat TEJ85 Batc 375DS
ch # h# 01
Mfg 05- Mfg 10-
date 2019 date 2020
have been done in 3 mediums
Decision of 316th meeting: Deferred for consideration on turn as product development data was
submitted on 11/06/2021
Firm has submitted fee of Rs 7500/- dated 31.10.2022 to revise Finished Product Specification as
per the reference product.
Strength
Sacubitril……..24.3mg
(as sacubitril valsartan sodium salt complex).
(#0709180) Dated 13-12-2017
Type of Form Form 5
Me-too status NA
Remarks of the Evaluator Assay is by HPLC method
Registration Board.
Certificate for NMDA provided

Manufacturer of API Sacubitril/valsartan: M/s Zhuhai Rundu Pharmaceutical Co.,
Ltd, China
Address: No 6, North airport Road Sanzao Town, Jinwan
Description of Pack
As per SRO
Accelerated: 40 °C ± 2 °C/75% ± 5%
Batch No. 374DS01 374DS02 374DS03
Batch Size 1500 1500 1500
No. of Batches 03
Date of Submission 28/5/2021 (14567)
firm and approved in 297 meeting.
Manufacturer
manufacturer
regulatory authority of country of origin. (Certificate# …) of GMP compliance
issued to M/s Zhuhai food and Drug
administration, valid Up to 21-12-2021.
Yes
stability study
Brand)
03 Batches:
374DS01 1500 10-2020

10-2020
374DS02 1500
374DS03 1500 10-2020
Record of comparative dissolution data No

(where applicable) Firm has submitted Comparative
dissolution study of their product with
product
name Tablets tan
tablet
# # 1
Mfg 05-2019 Mfg 10-2020
date date
Comparative dissolution studies for other
strengths not performed. It has been
performed with competitor product Uperio
100 mg by Novartis for higher strength i.e.
Sita/Met XR 100/1000 mg as formulation
is dose proportional)
Yes
21CFR & audit trail reports on product No
testing.
No
accelerated)
No.
1.
Registration Board.
for this regard.
provided
4.
2024 is attached
follows:
product
nam mg name lsartan
e Tablet tablet
s
ch # h# 01
Mfg 05- Mfg 10-
date 2019 date 2020
per the reference product
Decision: Approved with innovator’sspecifcations.
Strength
Sacubitril……..97.2 mg
(as sacubitril valsartan sodium salt complex)
(#0709182) Dated 13-12-2017
Type of Form Form 5
Me-too status NA
Remarks of the Evaluator Assay of ………..is by HPLC method
Registration Board.
Certificate for NMDA provided

Manufacturer of API sacubitril/valsartan: M/s Zhuhai Rundu Pharmaceutical Co.,
Ltd, China
Address: No 6, North airport Road Sanzao Town, Jinwan
Description of Pack
As per SRO
Accelerated: 40 °C ± 2 °C/75% ± 5%
Batch No. 376DS01 376DS02 376DS03
Batch Size 1500 1500 1500
No. of Batches 03
Date of Submission 11 June 2021 (11251)
firm and approved in 297 meeting.
Manufacturer
manufacturer
regulatory authority of country of origin. (Certificate# …) of GMP compliance
issued to M/s Zhuhai food and Drug
administration, valid Up to 21-12-2021.
Yes
stability study
Brand)
03 Batches:
376DS01 1500 10-2020

10-2020
376DS02 1500
376DS03 1500 10-2020
Record of comparative dissolution data No

(where applicable) Firm has submitted Comparative
dissolution study of their product with
product
name Tablets tan
tablet
# # 1
Mfg 05-2019 Mfg 10-2020
date date
Comparative dissolution studies for other
strengths not performed. It has been
performed with competitor product Uperio
100 mg by Novartis for higher strength i.e.
Sita/Met XR 100/1000 mg as formulation
is dose proportional)
Yes
21CFR & audit trail reports on product No
testing.
No
accelerated)
No.
1.
Registration Board.
for this regard.
provided
4.
2024 is attached
follows:
product
nam mg name lsartan
e Tablet tablet
s
ch # h# 01
Mfg 05- Mfg 10-
date 2019 date 2020
per the
reference product
Decision: Approved with innovator’s specifcations.
Case no. 02 Registration applications of drugs for which stability study data is submitted
Registration applications for Form 5F
a) Form 5F Import (Human)
393. Name, address of Applicant / Importer M/s Al-Habib Pharmaceuticals, Plot #81,
block B, SMCHS, Karachi.
Details of Drug Sale License of DSL No.: 1245
importer Address:Al-
Habib Pharmaceuticals, 81-B, block B,
SMCHS, Karachi.
Godown:
1. Plot No. 10 sector 25 KIA, Karachi
2. HT-8, Landhi Industrial Area, Karachi
Status: Drug License by way of wholesale
Name and address of marketing M/s Laboratories IMA S.A.I.C, Palpa 2862,
authorization holder (abroad) Ciudad Autonoma de Buenos Aires,
Argentina.
Name, address of manufacturer(s) M/s Laboratorios IMA S.A.I.C, Palpa 2862,
Ciudad Autonoma de Buenos Aires,
Argentina.
Name of exporting country Argentina
Detail of certificates attached (CoPP, CoPP:
Freesale certificate, GMP certificate) Original legalized CoPP (certificate No.
191106) valid till 30-10-2021 issued by
National Institute of Drugs, Argentina. The
applied product is available for free sale in
exporting country. The facilities and
operations conform to WHO-GMP.
Details of letter of authorization / sole Notarized copy of sole agency agreement is

agency agreement submitted whereby M/s Laboratorios IMA
S.A.I.C, authorizes M/s Al-Habib
Pharmaceuticals to Import and commercialize
different products including Gemcitabine
1000mg injection.

☒ Importer
giver)
☐ Export sale
☐ Buk import and local repackaging for
export purpose only
Dy. No. and date of submission Dy. No.22751: 20-08-2021
Details of fee submitted PKR 100,000 Dated: 29-03-2021
Differential fee : PKR 50,000 Dated : 05-07-
2021
The proposed proprietary name / brand GEMSTAR 200 mg
name
Strength / concentration of drug of Each Vial contains:
Active Pharmaceutical ingredient (API) Gemcitabine HCl ……………. 200 mg
per unit
Pharmaceutical form of applied drug Lyophilized Powder for injection
Pharmacotherapeutic Group of (API) Anti-Cancer (Nucleoside) (L01BC05)
specifications
Proposed Pack size 1 Vial
The status in reference regulatory Gemzar® 200 mg injection (USFDA
authorities Approved) by Eli Lilly
For generic drugs (me-too status) Gemzar® 200 mg injection by Eli Lilly
Pakistan (PvtP Ltd
substance.
Name, address of drug substance Hetero Labs Limited Survey.No.10, I.D.A.,
manufacturer Gaddapotharam Village, Jinnaram Mandal,
Medak District, Andhra Pradesh,
INDIA
(Conditions & duration of Stability batches of API at accelerated as well as real
studies) time conditions. The real time stability data is
conducted at 25°C ± 2°C. The stability study
Pharmaceutical Equivalence and Pharmaceutical equivalence has been
Comparative Dissolution Profile established against the reference product
Gemzar® 200mg injection by Eli Lilly
Analytical method Firm has submitted analytical method
validation/verification of product validation studies for the applied product.
Container closure system of the drug Type I, amber glass vial 50 ml
product Bromobutyl elastomeric stopper.
Aluminum capsule with flip off closure.
Stability study data of drug product, Firm has submitted stability study data of 3
shelf life and storage conditions batches
24 months real time stability data at 30°C ±
2°C / 65% ± 5%RH of 03 batches
06 month accelerated stability data 40°C ±
Evaluation by PEC:
S Section #. Deficiencies Response
No
1.33 Importer shall provide valid Original legalized CoPP
Certificate of Pharmaceutical (certificate No. 191106) valid
Product (CoPP) / Free Sale till 30-10-2021 issued by
certificate issued by relevant National Institute of Drugs,
regulatory authority in the country Argentina. The applied product
of origin and name of exporting is available for free sale in
country. exporting country. The facilities
and operations conform to
WHO-GMP. Firm submitted
that “This get expired during its
period in R& I that’s why as per
rule it will be considered as
valid”
1.33 The GMp of shanghai acebright Hetero Labs Limited
pharma co ltd. China is provided as Survey.No.10, I.D.A.,
API manufacture but at some place Gaddapotharam Village,
Hetero Labs Limited Survey.No.10, Jinnaram Mandal, Medak
I.D.A., Gaddapotharam Village, District, Andhra Pradesh,
Jinnaram Mandal, Medak District, INDIA is API manufacturer, its
Andhra Pradesh, INDIA is GMP is provided
mentioned as API manufacturer
clarification is needed in this regard.
1.33 The GMP certificate of Laboratories The GMP certificate of
IMA SAIC Argentina issued by Laboratories IMA SAIC
National administration of drug, Argentina issued by National
food and medical devices administration of drug, food and
(ANMAT)is valid till 2 April 2021. medical devices (ANMAT)
Provides Valid GMP valid till 3 April 2022 is
provided
2.3.S On API stability both IMA lab and No justification is given
hetro lab is mentioned justify
Decision 321st meeting: Clarification regarding the site wherein stability studies of drug substance
have been performed, since in submitted stability sheets both IMA lab and Hetro lab is mentioned.
REMARKS OF EVALUATOR:
Firm has submitted clarification that Finished product manufacturer is IMA lab that’s why they
have mentioned their name on every page of dossier , whereas the API manufacturer is Hetro lab
and they have performed the stability studies at their own site.
Decision: Approved
394. Name, address of Applicant / Importer M/s Al-Habib Pharmaceuticals, Plot #81,
Details of Drug Sale License of importer DSL No.: 1245
Address: Al-Habib Pharmaceuticals, 81-B,
Godown:
1. Plot No. 10 sector 25 KIA, Karachi
2. HT-8, Landhi Industrial Area, Karachi
Status: Drug License by way of wholesale
Name and address of marketing M/s Laboratories IMA S.A.I.C, Palpa 2862,
authorization holder (abroad) Ciudad Autonoma de Buenos Aires,
Argentina.
Name, address of manufacturer(s) M/s Laboratories IMA S.A.I.C, Palpa 2862,
Ciudad Autonoma de Buenos Aires,
Argentina.
Name of exporting country Argentina
Detail of certificates attached (CoPP, Free COPP:
sale certificate, GMP certificate) Original legalized CoPP (certificate No.
191106) valid till 30-10-2021 issued by
National Institute of Drugs, Argentina. The
applied product is available for free sale in
exporting country. The facilities and
operations conform to WHO-GMP.
Details of letter of authorization / sole Notarized copy of sole agency agreement is
agency agreement submitted whereby M/s Laboratories IMA
S.A.I.C, authorizes M/s Al-Habib
Pharmaceuticals to Import and commercialize
different products including Gemcitabine 200
mg injection.

☒ Importer
giver)
☐ Export sale
☐ Buk import and local repackaging for
export purpose only
Dy. No. and date of submission Dy. No. 22752 Dated: 20-08-2021
Details of fee submitted PKR 100,000 Dated: 29-03-2021

Differential fee: PKR 50,000 Dated : 05-07-
2021 (#98092840732), 100000 PKR,
(#1954777) dated 29-03-2021
The proposed proprietary name / brand GEMSTAR 1000 mg
name
Pharmaceutical ingredient (API) per unit Gemcitabine HCl (as free base) ………. 1000
mg
Pharmaceutical form of applied drug Lyophilized Powder for injection
Pharmacotherapeutic Group of (API) Anti-Cancer (Nucleoside) (L01BC05)
Proposed Pack size Type I amber glass 14 ml, 1 Vial
The status in reference regulatory Gemzar® 1000mg injection (USFDA
authorities Approved) by Eli Lilly
For generic drugs (me-too status) Gemzar® 100mg injection by Eli Lilly
Pakistan (Pvt) Ltd
substance.
Name, address of drug substance Hetero Labs Limited Survey.No.10, I.D.A.,
manufacturer Gaddapotharam Village, Jinnaram Mandal,
Medak District, Andhra Pradesh,
INDIA
(Conditions & duration of Stability studies) batches of API at accelerated as well as real
time conditions. The real time stability data is
conducted at 25°C ± 2°C. The stability study
Pharmaceutical Equivalence and Pharmaceutical equivalence has been
Comparative Dissolution Profile established against the reference product
Gemzar® 1000mg injection by Eli Lilly
(Batch # 1G00216-1)
Container closure system of the drug Type I, amber glass vial 14 ml
product Bromobutyl elastomeric stopper.
Aluminum capsule with flip off closure.
life and storage conditions batches
24 months real time stability data at 30°C ±
06 month accelerated stability data 40°C ±
(Batch# 34001/B, 34002/B, 34003/B)
Evaluation by PEC:
S Section #. Deficiencies Response
No
1.33 Importer shall provide valid Original legalized CoPP
Certificate of Pharmaceutical (certificate No. 191106) valid
Product (CoPP) / Free Sale till 30-10-2021 issued by
certificate issued by relevant National Institute of Drugs,
regulatory authority in the country Argentina. The applied product
of origin and name of exporting is available for free sale in
country. exporting country. The facilities
and operations conform to
WHO-GMP. Firm submitted
that “This get expired during its
period in R& I that’s why as per
rule it will be considered as
valid”
1.33 The GMp of shanghai acebright Hetero Labs Limited
pharma co ltd. China is provided as Survey.No.10, I.D.A.,
API manufacture but at some place Gaddapotharam Village,
Hetero Labs Limited Survey.No.10, Jinnaram Mandal, Medak
I.D.A., Gaddapotharam Village, District, Andhra Pradesh,
Jinnaram Mandal, Medak District, INDIA is API manufacturer, its
Andhra Pradesh, INDIA is GMP is provided
mentioned as API manufacturer
clarification is needed in this regard.
1.33 The GMP certificate of Laboratories The GMP certificate of
IMA SAIC Argentina issued by Laboratories IMA SAIC
National administration of drug, Argentina issued by National
food and medical devices administration of drug, food and
(ANMAT)is valid till 2 April 2021. medical devices (ANMAT)
Provides Valid GMP valid till 3 April 2022 is
provided
2.3.S On API stability both IMA lab and No justification is given
hetro lab is mentioned justify
Decision 321st meeting: Clarification regarding the site wherein stability studies of drug substance
have been performed, since in submitted stability sheets both IMA lab and Hetro lab is mentioned.
REMARKS OF EVALUATOR:
Firm has submitted clarification that Finished product manufacturer is IMA lab that’s why they have
mentioned their name on every page of dossier , whereas the API manufacturer is Hetro lab and they
have performed the stability studies at their own site.
Decision: Approved
395. Name, address of Applicant / Marketing ATCO Laboratories Limited

Authorization Holder Address: B-18,S.I.T.E., Karachi -
75700,Karachi.Sindh
Name, address of Manufacturing site. ATCO Laboratories Limited
Address: B-18,S.I.T.E., Karachi -
75700,Karachi.Sindh
☐ Importer
giver)
☐ Export sale
ITRACONAZOLE CAPSULE 100MG
name
Strength / concentration of drug of Active Each capsule contains:
Pharmaceutical ingredient (API) per unit Itraconazole Pellets equivalent to Itraconazole
MS 100mg
(Itraconazole Pellets 22.2% w/w)
Pharmacotherapeutic Group of (API) Azole Antifungal agent.
USP specifications
specifications
Proposed Pack size 1s, 4s, 7s, 10s, 14s, 20s, 28s & 30s
The status in reference regulatory Itraconazole 100mg Capsules
authorities Accord-UK Ltd.
For generic drugs (me-too status) Sporanox Capsule
Janssen-Cilag Pty Ltd
GMP status of the Finished product GMP Certificate issued on 06 November 2020
manufacturer valid till 05 November 2022.
Name and address of API manufacturer. Source of Pellets:
ALPHAMED FORMULATIONS PVT.,
LIMITED
Survey No.225, Sampanbole Village, Shamirpet
Mandal, Medchal Malkajgiridistrict Telangana -
500 101, India
Corporate office:
Metrochem API Private Limited.
Flat no. 302, Bhanu Enclave, Sunder nagar,
Erragadda, Hyderabad-500038
Telangana state, India
submitted.
product.
months
months
Batches: (BBA15001,BBA15002,BBA15003)
product.
Aspin pharma, by performing quality tests
(Identification, Assay, Dissolution, Uniformity
of dosage form).
brand, in Acid media (pH 1.0-1.2) & Phosphate
specificity.
Manufacturer of API Source of Pellets:
ALPHAMED FORMULATIONS PVT., LIMITED
Survey No.225, Sampanbole Village, Shamirpet Mandal, Medchal
Malkajgiridistrict Telangana - 500 101, India
API Lot No. 8000200-022
Description of Pack ALU-ALU Blister in printed carton
(Container closure
system)
Real Time: 0,3,6 (Months)
Batch No. N0374B N0375B N0376B
Batch Size 6000capsules 6000capsules 6000capsules
No. of Batches 03
Reference of previous approval of Rofl 500mg tablet Approved in DRB 277 held
firm (if any)
Approval of API/ DML/GMP certificate of Copy of GMP issued by (Drug Control
API manufacturer issued by concerned Administration, Government of Telangana
regulatory authority of country of origin. CFDA valid till 29/08/2022.
Documents for the procurement of API Submitted
import).
testing
accelerated)
Decision: Approved
396. Name and address of manufacturer M/S High –Q Pharmaceuticals, Plot No ; 224/23 Korangi
/ Applicant Industrial Area, Karachi.
Brand Name +Dosage Form + Platlo Plus 75mg/75mg Tablet
Strength
Composition Each film coated tablet contain
Clopidogrel (as bisulfate) (USP)….…….75mg
Acetylsalicylic acid (as enteric coated pellets)….75mg
Diary No. Date of R& I & fee Dy.No.10448; 31-07-2017; Rs.20,000/- (31-07-2017)
Pharmacological Group Anti-Platelet aggregation
Type of Form Form 5
Pack size & Demanded Price 10’s, 14’s, 28’s, ; As per SRO
Approval status of product in CoPlavix Tablet Of (TGA Approved)
Me-too status Clodril Plus Tablet M/s Macter International
GMP status Last GMP inspection was conducted on 30 June 2021
and the report shows good GMP.
Remarks of the Evaluator 1st letter: 04th June, 2018
Reminder letter: 9th October, 2018
Latest GMP inspection report (conducted within the period
of last one year).
Source of pellets of Acetyl salicylic acid (In case of
imported source remaining Rs: 80000/- fee)
GMP certificate of source of pellets
Stability study of 3 batches of pellets
Certificate of analysis of pellets
Previous decision(s) 296 Deferred for following:
Registration Board deferred the case for:
• Latest GMP inspection report (conducted within the
period of last three year).
• Source of pellets of Acetyl salicylic acid (In case of
imported source remaining Rs: 80000/- fee)
• GMP certificate of source of pellets, stability data
and COA of pellets.
• Clarification of the dosage of the Innovator product,
whether bilayer tablet or otherwise.
Remarks of evaluator:
S# Query Response
1 Latest GMP inspection Last GMP inspection
report (conducted within was conducted on 30
the period of last three June 2021
year). and the report shows
good GMP.
2 Source of pellets of Source is Surge lab
Acetyl salicylic acid (In Pakistan
case of imported source
remaining Rs: 80000/-
fee)
3 GMP certificate of Source is Surge lab
source of pellets, Pakistan
stability data and COA
of pellets. GMP
certificate of source of
pellets, stability data and
COA of pellets
4 Clarification of the Highnoon is making
dosage of the Innovator this table by
product, whether bilayer compression and then
tablet or otherwise. film coating is done, in
TGA biconcave coated
tablet is mentioned.
Previous Decision 312 Deferred for revision of formulation and manufacturing
method as per reference product and confirmation of
availability of bilayered machine
Remarks of Evaluator VII The Inspection report dated 6 July 2021 confirms the
availability of bilayer machine.
In TGA Australia the dosage form is described as biconvex
tablet film coated not bilayered detailed method of
manufacturing is also submitted by the firm.
Decision of 313th meeting: Deferred for deliberation in forthcoming meeting regarding approval
of the applied formulation as bi-layered and /or plain tablet.
Remarks of Evaluator xx:
Formulations approved in reference countries (EMA /TGA) are bi layered tablet in which
clopidogrel hydrogen sulfate is included in one layer and aspirin is in another layer.
Firm has submitted revised formulation as per “EMA assessment report” (along with fee of Rs
30,000/- dated 19.10.2022) as follows:
Each film coated bi layered tablet contains:
Acetylsalicylic acid ……………………..75mg
Decision: Approved as follows:
Each film coated bi layered tablet contains:
Acetylsalicylic acid ……………………..75mg
Deferred case of 316th meeting:

397. Name and address of M/s Cure Laboratories.
manufacturer / Applicant Plot # 11,12,NS-2 RCCI, Industrial Estate, Rawat, Islamabad
By
M/s Vision Pharmaceuticals.
Plot # 22,23, Industrial Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Esocure 40mg Injection
Composition Each vial contains:
Esomeprazole as Sodium…40mg
Diary No. Date of R& I & fee Form-5 Dy.No 13942 dated 06-03-2019 Rs.50,000/- Dated
06-03-2019 (#0807480)
Pharmacological Group Proton pump inhibitor
Form Form-5
Finished product Specifications Manufacturing specifications
Approval status of product in Reference Nexium IV 40mg/vial injection by M/s ASTRAZENECA
Regulatory Authorities PHARMS (USFDA approved)
Me-too status Esold 40mg/vial Injection of M/s Weather Folds
Pharmaceutical, Reg No. 74824
GMP status M/S Vision:
GMP Certificate issued on 08.05.2018.
Remarks of Evaluator VII The applicant has submitted that they are not having any
manufacturing on contract basis from any firm. Currently the
firm have 3 Sections.
Remarks of Evaluator VII Total sections: 3
Total products on toll: No
Previous decision (296) Deferred for consideration on its turn
Decision of 316th meeting: Deferred as already deferred for capacity assessment (manufacturing and
testing facility etc) of M/s vision in 313th meeting of Registration Board, For “Dry Powder Injection
section (General)” & “Dry Powder Injection section (Steroid )”, notified vide letter No. F.15-1/2022-PEC
dated 08-03-2022.
Decision: Approved with innovator specifications. Registration letter will be issued after submission
of 7500/- fee for correction/pre-approval change ,as per notification No.F.7-11/2012-B&A/DRAP
dated 13-07-2021.
Name and address of manufacturer / M/s Cure Laboratories. Plot # 11,12,NS-2 RCCI, Industrial
Applicant Estate, Rawat, Islamabad
By
M/s Vision Pharmaceuticals Plot # 22,23, Industrial Triangle,
Brand Name +Dosage Form + Strength P-Role 40mg Injection
Composition Each vial contains:
Omeprazole as Sodium………40mg
06-03-2019 (#0807479)
Pharmacological Group Proton pump inhibitor
Form Form-5
Approval status of product in Reference Omeprazole 40mg Powder for Solution for Infusion by M/s
Regulatory Authorities Sandoz Limited, MHRA Approved.
Me-too status RISEK 40MG INJECTION. Reg. No. 45617
GMP Certificate issued on 08.05.2018.
Remarks of Evaluator VII The applicant has submitted that they are not having any
manufacturing on contract basis from any firm. Currently the
firm have .. sections.
Decision of 316th meeting: Deferred as already deferred for capacity assessment (manufacturing and
testing facility etc) of M/s vision in 313th meeting of Registration Board, For “Dry Powder Injection
section (General)” & “Dry Powder Injection section (Steroid )”, notified vide letter No. F.15-1/2022-PEC
dated 08-03-2022.
dated 13-07-2021.
Name and address of manufacturer / M/s Cure Laboratories. Plot # 11,12,NS-2 RCCI, Industrial
Applicant Estate, Rawat, Islamabad
By
M/s Vision Pharmaceuticals. Plot # 22,23, Industrial Triangle,
Brand Name +Dosage Form + Strength Quantum 5mg Injection
Composition Each ampoule contains:
Cholecalciferol …5mg
06-03-2019 (#0807483)
Pharmacological Group Vitamin D3 analogue
Form Form-5
Pack size & Demanded Price 1 ml As per SRO
Approval status of product in Reference Vitamin D3 Good 200,000 IU / 1 ml IM solution for injection
Regulatory Authorities of ( ANSM France approved)
Me-too status D-Tres 5mg/ml Injection by M/s Sami (Reg#076115)
GMP inspection dated 11-2-2019 concluding good GMP
compliance
Remarks of Evaluator VII Each Ampoule (1ml) Contains:
Cholecalciferol (Vitamin D3)…200,000 IU Eq. to 5mg/ml
Decision 316th meeting: Deferred according to the decision of 313th meeting of Registration Board, for
capacity assessment of manufacturing and testing facility of M/s Vision Pharmaceuticals Pvt. Ltd. For
“Dry Powder Injection vial section (General)” & “Dry Powder Injection section (Steroid )”, notified vide
letter No. F.15-1/2022-PEC dated 08-03-2022.
Remarks of Evaluator xx:
Registration Board has discussed the capacity assessment inspection report in details in 320th meeting.
Deliberations were made on used and available manufacturing and quality control capacity keeping in
view all registered product and currently applied products. After thorough deliberation, the Board decided
to allow contract manufacturing from M/s Vision Pharmaceuticals (Pvt) Ltd Plot No. 22 – 23, Industrial
Triangle Kahuta Road, Islamabad for following sections:
• Sterile Dry Powder Injection Vial (General)
• Sterile Dry Powder Injection Vial (Steroid
dated 13-07-2021.
Deferred case of 285th meeting:
398. M/s Global Vorzol 200mg Form 5-D Vfend Infusion Deferred for The firm has
Pharmaceutic Dry powder 16-06-2011 by PF Prism confirmation changed the
als, Injection Dy.No.2120 (USFDA of me too application
Islamabad Rs.15000/= Approved) status as from Form-
Each vial Rs.5000/= reported 5D to Form-5
contains:- 26-03-2015 Vorif by reference is in- The firm has
Voriconazole 1’s Ferozsons correct. submitted me-
…….…..200 As Per SRO (M-265) too reference
mg Last inspection Deferred for as “Vivid
report evidence of Injection of
(Antifungal) 23-24-08-2016 approval of S.J. & G.
Overall cGMP manufacturing Fazul Ellahie,
compliance is facility of “Dry Karachi (Reg
# 070582)”.
considered as powder The firm has
good. Lyophilized changed the
injection” by application
Central from local
Licensing manufacture
Board. to contract
(M-278) manufacturing
from M/s
Vision
Pharma,
Islamabad.
Differential
fee of Rs.
30,000/-
(deposit slip#
0742858)
dated 28-08-
2018 has been
submitted.
Decision of 285th meeting :
Deferred for following:
Submission of remaining fee of Rs. 20,000/- for contract manufacturing.
Evidence of manufacturing facility for ready to fill powder.
Now the firm has submitted differential fee of Rs 20,000/- for contract manufacturing and evidence of
section approval (vide letter No F.1-26/2009-Lic (Vol-1) dated 07th June 2021) wherein “sterile dry
powder injection (general)” of M/s Vision Pharma, Islamabad is confirmed.
Decision: Deferred for evidence of availability of required manufacturing facility of “Dry Powder
Injection (Lyophilisation)” from CLB since innovator drug product is manufactured by way of
Lyophilisation.
Veterinary:
399. Name and address of M/s. Elko Organization (Pvt) Ltd , Plot No. 27 & 28, sector
manufacturer / Applicant 12-B North Karachi Industrial Area, Karachi
Brand Name +Dosage Link injection
Form + Strength
Diary No. Date of R& I & Dy.No.24288, 12-6-7, Rs. 15,000/- (12,july 2018), 5000 (12
fee july 2018)
Composition Each ml contains: -
Buserelin acetate…0.0042mg eq to 0.004mg Buserelin
Pharmacological Group Gonadotropin releasing hormone analogues
Type of Form Form-5
Finished Product In house
Specification
Pack size & Demanded 5ml; Decontrolled
Price
Approval status of product Busol – 0.004 mg/ml solution for injection aniMedica GmbH,
in Reference Regulatory UK
Authorities.
Me-too status Conceptal Injection of Star Laboratories (Pvt) Ltd, Lahore
(Reg # 058939).
GMP status Routine GMP inspection conducted on 13-06-2017 & 06-07-
2017 concluded that the firm is operating at good level of
GMP compliance as of today
Remarks of the Evaluator. VET
Decision of 285th meeting: Deleted since it is not priority
Remarks of Evaluator:’ Firm has submitted the reference of already registered product
“LINK INJECTION (50ml) (Reg No 084981)” and stated that
5ml pack size is more economical for the farmers, it has much
priority for firm to market the said drug for poor farmers.
Generc version: Conceptal Injection of Star Laboratories (Pvt)

Ltd, Lahore (Reg # 058939).
Decision: Deferred for opinion of Veterinary expert committee.
M/s Star laboratories (Pvt) Ltd. 23 kilometer, multan road,

400. Name and address of Lahore
manufacturer / Applicant
Brand Name +Dosage Form + Montel Paedrtric 4 mg tablet
Strength
Diary No. Date of R& I & fee Form-5 Dy.No 462 dated 27-1-2014 Rs. 20,000
Montelukast as sodium…4 mg
Pharmacological Group Leutkotriene Receptor Antagonist
Type of Form Form-5
Finished Product Specification Innovators
Pack Size & Demanded Price As per SRO
Approval Status of Product in Singulair 4 mg chewable tablets (USFDA)
Me-too Status Bronsecur of Pfizer Laboratories Ltd
Remarks of the Evaluator. Latest GMP inspection report was required, the shortcoming
was communicated to firm on 11.12.2018.
Now the firm has submitted copy of GMP inspection report
conducted on 21.01.2020 to 24.01.2020 wherein GMP was at
satisfactory level.
Decision: Approved with USP specifications. Registration letter will be issued after
submission of 7500/- fee for correction/pre-approval change (“Each Chewable tablet” in label
claim & USP specification), as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
401. Name, address of Applicant / Marketing M/s Himark Laboratories Private Limited
Authorization Holder Lahore
Name, address of Manufacturing site. M/s Himark Laboratories Private Limited
Plot 37-A, Sundar Industrial Estate Lahore
☐ Importer
giver)
☒ Generic Drug Prod-uct (GDP)
☐ Export sale
Dy. No. and date of submission Dy. No. 13410 dated 02 June 2022
Details of fee submitted PKR 30,000/-: dated: 11 Feb 2022
The proposed proprietary name / brand Himox 400 mg film coated tablet
name
Active Pharmaceutical ingredient (API) Moxifloxacin as hydrochloride .... 400 mg
per unit
Pharmaceutical form of applied drug White to off-white color oblong shaped film
coated tablet
USP
specifications
The status in reference regulatory AVELOX 400mg tablet M/S Bayer Health
authorities Care Inc. (USFDA Approved).
For generic drugs (me-too status) Mofest 400 mg tablet by M/s Sami
Pharmaceuticals (Pvt.) Ltd.
Reg. No. 050745
approved.
Name and address of API manufacturer. Pharmagen Limited
Ferozepur Rd, Sue Aasal, Kasur
manufacturers, Characterization, impurities,
substance. The firm has summarized
information of drug product including its
protocols, control of excipients, control of
drug product, specifications, analytical
substance.
Stability studies Firm has submitted stability study data of 6
months accelerated and 36 months real time
data of 3 batches of drug substance.
Pharmaceutical equivalence and Firm has submitted pharmaceutical
comparative dissolution profile equivalence study of trial formulation (B # T-
70) with comparator product MOXIGET
400mg Tablet (B # 205F31) of M/s GETZ
pharma. The results of the quality tests of both
products fall within the specifications and are
comparable. The firm has performed
comparative dissolution profile in pH 1.2,
acetate buffer pH 4.5 and phosphate buffer
6.8. The results showed that similarity factor
f2 was above 50 in three media.
Analytical method Firm has submitted report of verification
validation/verification of product studies of analytical method for the drug
substance. Firm has submitted report of
validation of analytical method for the drug
product.

Manufacturer of API Pharmagen Limited Lahore, Pakistan
API Lot No. 00510711/002/2021
Description of Pack
No. of Batches 03
the firm (if any)
Approval of API/ DML/GMP certificate Copy of GMP certificate Ref. No. 06/2019-
of API manufacturer issued by DRAP (AD/607409-530) Dated 11-01-2019.
country of origin.
Documents for the procurement of API API (Moxifloxacin HCl) has been purchase
with approval from DRAP (in case of from Pharmagen Limited which is a local
import). manufacturer.
Data of stability batches will be Firm has submitted record of testing of all
supported by attested respective batches along with chromatograms, raw data
documents like chromatograms, Raw sheets, COA and summary data sheets.
etc.
Compliance Record of HPLC software Audit trail has been submitted
testing
Record of Digital data logger for Firm has submitted record of data logger for
temperature and humidity monitoring of temperature and humidity monitoring of real
stability chambers time and accelerated stability chambers.
S No Deficiencies (Letter issued dated 15 Reply (dated 19.09.2022)
August 2022)
Control of drug substance is required Complied
Firm has submitted analytical report
and analytical testing methods from
both Drug substance and Drug product
manufacturer.
Provide summarized tabulated results of Complied
verification studies including specificity, Analytical verification studies are
accuracy and repeatability (method submitted from finished product
precision) performed by the Drug Product manufacturer.
manufacturer
Provide results of analysis of relevant Complied
batch(es) of Drug Substance performed Certificate of Analysis (CoA) of the
by Drug Product manufacturer used same batch (no. 00510711/002/2021)
during product development and stability from Drug Substance /Active
studies, along with Certificate of Analysis Pharmaceutical Ingredient manufacture
(CoA) of the same batch from Drug is submitted.
Substance /Active Pharmaceutical
Submitted specifications have different Firm has submitted finished product
parameters as compare to USP specifications. All quality tests
monograph specially in case of including dissolution acceptance
dissolution so clarification is required in criteria is as per USP monograph.
this regard
Decision: Approved
402. Name, address of Applicant / Marketing M/s Novamed Pharmaceuticals (Pvt.) Ltd Lahore
Name, address of Manufacturing site. M/s Novamed Pharmaceuticals (Pvt.) Ltd., 28km
Ferozepur Road Lahore
☐ Importer
giver)

☐ Export sale
Details of fee submitted PKR 50,000/-: dated 18/5/2020 (#2004310)
The proposed proprietary name / brand name Invid -3 Injection 300,000IU
Strength / concentration of drug of Active Each ml contains:
Pharmaceutical ingredient (API) per unit Cholecalciferol…………..…300,000IU
Pharmaceutical form of applied drug Clear colorless oily liquid free from foreign
particles
Pharmacotherapeutic Group of (API) Fat soluble vitamin, Vitamin-D Analogue
(IM injection)
Reference to Finished product specifications Manufacturer Specs
Proposed Pack size 1’s (1ml), 5’s (1ml), 100’s
The status in reference regulatory authorities XARENEL 300,000 IU / ml solution for
injection Italy Approved
GMP status of the Finished product manufacturer License granted on 08/04/2006 and renewed on
08/04/2021 General liquid section approved and
GMP certificate on 06/08/2021
Name and address of API manufacturer. Sichuan Province Yuxin Pharmaceutical Co.,
Ltd. Weicheng Jinhe East Road, Shifang City,
Sichuan
submitted.
impurity D, G & related substances (impurity A
& unspecified), specifications, analytical
Real time: 5°C ± 3°C / 65% ± 5% RH for 48
months
months
Batches: (B-3-01-130601 , B-3-01-130602 ,
B-3-01-130603)
dissolution profile established against the innovator that is Dibase
by Abiogen Pharmaceuticals by performing
quality tests (Identification, Assay, Dissolution,).
CDP has not been applicable
specificity.
Remarks:
The excipient use is XARENEL 300,000 IU / ml solution for injection: refined olive oil for injectable
use.
The overage added is 25%
The membrane filtration is done
Particulate matter is counted by particulate counter
Manufacturer of API Sichuan Province Yuxin Pharmaceutical Co., Ltd.
Weicheng Jinhe East Road, Shifang City, Sichuan
API Lot No. B-1-51-M190105
Description of Pack USP Type-1 Glass ampoule blistered in Alu - PVC and further
(Container closure system) packed in unit carton (1’s ,5’s (1ml)
Batch No. TP-140-T2 TP-140-T3 TP-140-T4
Batch Size 5000 Ampoule 5000 Ampoule 5000 Ampoule
No. of Batches 03
Reference of previous approval of applications with The firm has submitted copy of Last inspection
stability study data of the firm (if any) Report conducted on 24/01/2018.
Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. SC20160032 issued
manufacturer issued by concerned regulatory by CFDA valid till 17/11/2021.
Documents for the procurement of API with Copy of AD Attested invoice No F 1919090 vide
approval from DRAP (in case of import). No.5354/2019/DRAP-AD-CD(I&E) dated
16/04/2019 is submitted wherein the permission
to import Vitamin D3 API is granted.
Data of stability batches will be supported by Submitted

attested respective documents like chromatograms,
Compliance Record of HPLC software 21CFR & Submitted
audit trail reports on product testing
Record of Digital data logger for temperature and Submitted
Remarks OF Evaluator VII:
S. Sections Observations/ Short- Remarks

No comings
1. 1.3.4 Valid Drug Manufacturing Copy of valid DML is submitted
License (DML) of
manufacturer/Applicant
shall be submitted as
submitted DML was not
valid.
2. 2.3.R.1.1 Provide copy of Batch Copies of Executed/Trial batches
manufacturing record & Commercial batch BMR were
(BMR) for all the batches attracted in 3.2.R.
of the drug product for However, Copies of BMR of all
which stability study data is the batches of the drug product for
provide in module 3 section which stability study data are
3.2.P.8.3. provided in 2.3.R.1.1.
3. 3.2.P.8 Stability: on commercial As per COA,40MIU is the
Invoice the quantity potency of vitamin D3 i.e
mentioned was Vit D3 40,000,000 IU/gm , as per label
40MIU but the prepare claim of the applied strength the
strength is 300,000IU quantity of vitamin d3 with this
potency is calculated which is
equivalent to vitamin d3
300,000IU (7.5 mg).
COA and calculation is attached.
4. 3.2.P.1 The composition contains Compatibility of crodamol oil and
BHA and Crodamol oil but BHA were performed against
in the reference product Vitamin d3 Active, no
Xarenel 300,000IU/ml interference was observed during
solution for injection. The the compatibility Analysis
excipient use is refined
olive oil for injectable use.
5. 3.2.P.1 Description and Overage was reflecting in the
composition of the drug amount of API /unit, however
product Details of Overage composition with overage details
not provide in the is attached.
formulation
6. 3.2.S.7.3 Justification of the stability Revised Stability Data of new
of the drug substance at batches is provided
25˚C±2˚C/
60%RH±5%RH.
In case where the real time
stability data of the drug
substance is conducted at
25˚C±2˚C/60%RH±5%RH,
The firm shall submit the
record of data logger for the
storage condition
throughout the
transportation.
7. 3.2.S.4.1 Specification assay limit is According to USP 42 NF 37
mentioned as 97-103% but Acceptance criteria limit for
in USP the limit is from 90- Cholecalciferol material is 97-
120%. 103%.Copy of USP monograph is
provided for reference.
8. 3.2.P.1 In composition no Overage Overage was reflecting in the
is mentioned in this section. amount of API /unit, however
composition with overage details
is provided.
9. 2.3.P.3.2 In 2.3.P.3.2 batch formula it Vitamins generally have tendency
is mentioned that after 6 to degrade. As vitamin D3 is
month of accelerated and photolytic, thermally unstable and
real time stability studies have oxidative nature but at the
product is stable so overage same time it is a fat-soluble
will be omitted during vitamin and more stable with
commercial validation Crodamol Oil, because of this
batches but in the assay, property product show no
there is a steady decrease in significant change in assay as
assay limit. Justification is defined in guideline.
needed about this
statement.
10. 3.2.A and 3.2R Appendices and regional Appendices and regional
information is missing. information as per approved
checklist of 296th DRB is
attached.
11. 3.2.P.8 Justify the result of Assay Vitamins generally have tendency
as all the batches just to degrade. As vitamin D3 is
showed minor decrease in photolytic, thermally unstable and
assay results less than have oxidative nature but at the
which is usually observed same time it is a fat-soluble
in vitamin preparations. vitamin and more stable with
Scientific Crodamol Oil, because of this
Justification/clarification is property product show no
required in this regard. significant change in assay as
defined in guideline.
12. 3.2.P.2.1.1 As As per relevant Owing to the prevailed condition
guidelines & structure of of covid throughout the world We
Form 5F, Comparative had performed PE after
assay Pharmaceutical formulation development due to
equivalence has to be unavailability of the Innovator
performed at the time pack. So, as per the need of hour
formulation development, or to overcome this challenge we
while according to your deviated from the chronological
submitted data, it has been flow. However, we confirm that
performed after this deviation will not be repeated.
commencing stability
studies. Justification shall
be submitted.
Decision of 316:
Deferred for the following
The applied product’s monograph is present in BP but the specification and methods applied are not according to
BP monograph.
Remarks of evaluator VII
In BP monograph method given for assay analysis is by UV spectroscopy while invid-3 was tested by more
stringent HPLC method. As a matter of fact, HPLC method exhibited the advantage of high precision and high
recovery and high sensitivity
Decision of 321st meeting: Deferred for comparative analysis of drug product specification proposed by the
applicant and those recommended by BP monograph of Vitamin D3 injection
Remarks of evaluator XX
Firm has submitted comparative analysis of drug product specification proposed by the applicant and those
recommended by BP monograph of Vitamin D3 injection, as follows:
Test
Sr.# Novamed Specifications B.P Monograph Gap Analysis
Description
Label Claim Each ml contains: Each ml contains: No changes
Vitamin D3……..300000 I.U Vitamin D.…300000
(Colecalciferol 7.5mg) I.U (Colecalciferol
7.5mg)
Characteristics Colorless oily liquid A pale yellow, oily

Colorless to pale
liquid yellow oily liquid
Identification HPLC RT Spectrum UV UV
Wavelength 265nm Spectrophotometry Spectrophotometry
Wavelength 500nm Wavelength
500nm
Assay Test NLT 95.0% and NMT 125.0% NLT 90.0% and NMT Release Limit
(Release Limit) 110.0% (Release based on release
Limit) criteria given by
USP for vitamin
assayed by HPLC
Deliverable 1.0ml-1.15ml ----- Not

Volume Applicable
Particulate Visible Particles Visible Particles

Matter
Sub-visible Particles Sub-visible Particles
NMT 6000 Part./ Container NMT 6000 Part./

of size Container of size
No change
≥ 10µm & ≤ 25µm & ≥ 10µm & ≤ 25µm
&
NMT 600 Part./Container NMT 600

of size Part./Container of size
≥ 25µm ≥ 25µm
Sterility Test Should be Sterile ` Should be Sterile No change
Bacterial NMT 47 EU/ml Limit not Limit not
Endotoxin mentioned mentioned
Test
Furthermore, firm has submitted rationale of adopting HPLC method due to following reason:
As per BP method, UV spectrophotometer at 500nm and 550nm mentioned, whereas we performed on HPLC
method of Analysis (Novamed specs) which is superior technology with respect Accuracy, precision and
Linearity. The reason for shifting to HPLC method of analysis is based on;
Very short-range spectrum difference in wavelength (500nm-550nm) and there is possibility of diluent/ethyl
oleate will interfere in absorbance at visible region (500nm-550nm).
Color Solution which gives false positive results at visible region (500nm-550nm).
Method robustness depends upon difference of 500nm and 550nm, while HPLC method provide better
quantification with respect to standard and sample spectrum.
Remarks The acceptance criteria of assay in Drug product specification proposed by the firm is NLT 95.0% and
of NMT 125.0% which is less stringent than acceptance criteria of assay in BP specification i.e NLT
evaluator 90.0% and NMT 110.0%.
XX Later on Firm has revised the acceptance criteria as per BP i.e NLT 90.0% and NMT
110.0%(dated 10.11.2022)
Decision Approved with BP specification.
• Registration letter will be issued after submission of 7500/- fee for correction/pre-
approval change ,as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Deferred cases of 295th meeting:

403. Name and address of "M/s Aims Pharmaceuticals.
manufacturer / Applicant Plot # 291, Industrial Triangle, Kahuta Road,
Islamabad"
Brand Name +Dosage Form + Terbiaim 250mg Tablet
Strength
Terbinafine ( as hydrochloride)…250mg
Pharmacological Group Antifungal
Type of Form Form-5
Pack size & Demanded Price 10’s: Rs.474.00
Approval status of product in Approved in US-FDA(uncoated tablet)
Me-too status Logirid Tablet 250mg of Lowitt Pharmaceutical (Pvt)
Ltd,
GMP status Dated: 31-05-2018
“The panel unanimously recommended the grant of
renewal of DML after thorough and detailed
evaluation/inspection.”
Remarks of the Evaluator (VIII) Reference product is approved as uncoated tablet but
you have applied for coated tablet. Submit form 5,
master formulation & manufacturing method either in-
line with reference product along with requisite fee or
evidence of approval of applied drug product as film
coated tablet.
Decision of 295th meeting: Deferred for clarification of applied formulation regarding
coated or uncoated tablet is required as submitted master formulation contains ingredients
of coating but Outline of method of manufacturing do not contain step of coating.
Firm has revised formulation/label claim as per reference product as follows:

However firm has submitted copy of fee challan and endorsement from DRAP (Rs 5000/-
dated 21.02.2020) submitted in this regard.
Registration letter will be issued after submission of differential fee of 2500/- fee for
correction/pre-approval change ,as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-
2021 along with latest GMP inspection report conducted within last three years.
404. Name and address of Manufacturer "M/s Aims Pharmaceuticals.

/ Applicant Plot # 291, Industrial Triangle, Kahuta Road, Islamabad"
Brand Name+ Dosage Form Azeskin 200mg Cream
+Strength
Composition "Each Gram Contains:
Azelaic Acid…200mg"
Diary No. Date of R&I & fee Dy.No 34333 dated 16-10-2018 Rs.20,000/-
Pharmacological Group anti-acne preparations for topical use
Type of Form Form 5
Finished Product Specification Manufacturer’s Specification
Pack Size & Demanded Price 15gm, 30gm: As per SRO
Approval status of product in Approved in MHRA(emc)
Me-too status Not verifiable.
GMP status Date: 31-05-2018
Comments:
Remarks of the Evaluator (VIII) Approval of section/manufacturing facility by the
Central Licensing Board. However, you may submit
panel inspection report for renewal of DML verifying
the section/manufacturing facility.
Evidence of applied formulation/drug already approved
by DRAP (generic / me-too status) alongwith
registration number, brand name and name of firm, as
the provided evidence is not verifiable.
Decision of 295th meeting: Deferred for the following:
Evidence of applied formulation/drug already approved by DRAP (generic / me-too status)
alongwith registration number, brand name and name of firm, as the provided evidence is not
verifiable.
Approval of section/manufacturing facility by the Central Licensing Board
Generic version of applied formulation is found as follows:
Acnegen cream 20% (Reg No 070195) by M/s Biogen pharma, Rwp
Firm has submitted copy of letter (No F.6-1/2009-Lic(M-216) dated 16th March 2008 wherein
ointment (general) section is approved
Decision: Approved with innovator’s specification. Registration letter will be issued after
submission of 7500/- fee for correction/pre-approval change ,as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021 along with latest GMP inspection report
conduicted within last three years.
405. Name and address of Manufacturer "M/s Aims Pharmaceuticals.

/ Applicant Plot # 291, Industrial Triangle, Kahuta Road, Islamabad"
Brand Name+Dosage Aimpride 2mg Tablet
Form+Strength
Composition "Each Film Coated Tablet Contains:
Glimepiride…2mg"
Pharmacological Group Sulfonylureas
Type of Form Form 5
Approval status of product in Approved in USFDA
Me-too status Glimera 2mg Tablet of PPP, Karachi
Comments:
Remarks of the Evaluator (VIII) Reference product in approved as uncoated tablet but
you have applied for film coated tablet. Submit form 5,
master formulation & manufacturing method either in-
line with reference product along with submission of
requisite fee or evidence of approval of applied drug
product as film coated tablet.
Decision of 295th meeting: Deferred for submission of either evidence of approval of
reference product as film coated tablet or otherwise for revision of applied formulation in line
with reference product i.e. uncoated tablet alongwith submission of requisite fee, master
formulation & manufacturing method.

Glimepiride…2mg"
However firm has submitted copy of fee challan and endorsement from DRAP (Rs 5000/-
dated 21.02.2020) submitted in this regard.
Glimepiride…2mg"
Registration letter will be issued after submission of 2500/- fee for correction/pre-
approval change ,as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021 along
with latest GMP inspection report conduicted within last three years.
406. "M/s Aims Pharmaceuticals.

Name and address of Manufacturer / Plot # 291, Industrial Triangle, Kahuta Road, Islamabad"
Applicant
Brand Name+Dosage Form+Strength Aimpride 4mg Tablet
Composition "Each Film Coated Tablet Contains:
Glimepiride…4mg"
Pharmacological Group Sulfonylureas
Type of Form Form 5
Approval status of product in Approved in USFDA
Me-too status Glimera 4mg Tablet of PPP, Karachi
Comments:
“The panel unanimously recommended the grant of renewal
of DML after thorough and detailed evaluation/inspection.”
Remarks of the Evaluator (VIII) Reference product in approved as uncoated tablet but you
have applied for film coated tablet. Submit form 5, master
formulation & manufacturing method either in-line with
reference product along with submission of requisite fee or
evidence of approval of applied drug product as film coated
coated tablet.
Decision of 295th meeting: Deferred for submission of either evidence of approval of reference
product as film coated tablet or otherwise for revision of applied formulation in line with reference
product i.e. uncoated tablet alongwith submission of requisite fee, master formulation &

Glimepiride…4mg"
However firm has submitted copy of fee challan and endorsement from DRAP (Rs 5000/- dated
21.02.2020) submitted in this regard.
Glimepiride…4mg"
Registration letter will be issued after submission of 2500/- fee for correction/pre-approval
change ,as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021 along with latest GMP
inspection report conduicted within last three years.
407. "M/s Aims Pharmaceuticals.

Name and address of Manufacturer / Plot # 291, Industrial Triangle, Kahuta Road, Islamabad"
Applicant
Brand Name+ Dosage Form Dermera Cream 40mg/0.5mg/0.1mg Cream
+Strength
Hydroquinone…40mg
Tretinoin…0.5mg
Fluocinolone Acetonide…0.1mg"
Pharmacological Group Anti-fungal
Type of Form Form 5
Approval status of product in Approved in US-FDA
Me-too status Tricuma Cream Topical of Ciba Pharmaceuticals
Comments:
Remarks of the Evaluator (VIII) Approval of section/manufacturing facility by the Central
Licensing Board. However, you may submit panel inspection
report for renewal of DML verifying the
section/manufacturing facility.
Decision of 295th meeting: Deferred for approval of section/manufacturing facility by the Central
Licensing Board.
ointment (general) section is approved
Decision: Approved. Firm shall submit latest GMP inspection report conduicted within last
three years before issuance of registration letter.
"M/s Aims Pharmaceuticals.

408. Name and address of Plot # 291, Industrial Triangle, Kahuta Road, Islamabad"
Manufacturer / Applicant
Brand Name+ Dosage Form Vagistat 20mg Cream
+Strength
Butoconazole…20mg"
Pharmacological Group Anti-fungal
Type of Form Form 5
Approval status of product in Approved in Israel (as provided by the firm)
Me-too status Could not be confirmed
Comments:
Remarks of the Evaluator (VIII) Approval of section/manufacturing facility by the Central
Licensing Board. However, you may submit panel inspection
report for renewal of DML verifying the
section/manufacturing facility.
Evidence of approval of applied formulation in reference
regulatory authorities/agencies which were declared/
approved by the Registration Board in its 275th meeting.
Evidence of applied formulation/drug already approved by
DRAP (generic / me-too status) alongwith registration
Decision of 295th meeting: Deferred for the following:
Evidence of approval of applied formulation in reference regulatory authorities/agencies which were
declared/approved by the Registration Board in its 275th meeting.
Evidence of applied formulation/drug already approved by DRAP (generic / me-too status) alongwith
registration number, brand name and name of firm.
Approval of section/manufacturing facility by the Central Licensing Board. However, you may
submit panel inspection report for renewal of DML verifying the section/manufacturing facility.
Formulation approved in USFDA is Butoconazole nitrate cream 2% hence label claim has to be
standardized alongwith fee.
The reference of generic version provided by the firm is not verifiable.
ointment (general) section is approved.
Decision: Deferred for Evidence of applied formulation/drug already approved by DRAP
(generic / me-too status) along with registration number, brand name and name of firm.
Item No. XI: Agenda of Evaluator (Mr. Umar Latif)
Item no 1: Routine Application on Form 5-F
409. Name, address of Applicant / M/s Vision Pharmaceuticals (Pvt.) Ltd.

Marketing Authorization Holder Plot # 22-23 Industrial Triangle, kahuta
Road, Islamabad-25000, Pakistan
Name, address of Manufacturing site. M/s Vision Pharmaceuticals (Pvt.) Ltd. Plot #
22-23 Industrial Triangle, kahuta Road,
Islamabad-25000, Pakistan
☐ Importer
giver)
☐ Export sale
Details of fee submitted Rs.20,000/- dated 17-12-2020 Slip no.
2051711
Visoline 0.9% infusion/injection
name
Active Pharmaceutical ingredient (API) Sodium chloride.…….9mg
per unit
Pharmaceutical form of applied drug IV Infusion/Injection
Pharmacotherapeutic Group of (API) Crystalloid Fluid
USP specs
specifications
Proposed Pack size 1’s, 10ml
The status in reference regulatory Sodium chloride 0.9% infusion of HOSPIRA
authorities (FDA approved)
For generic drugs (me-too status) Celine 0.9% Infusion of Surge laboratories
Pvt. Ltd.
manufacturer inspection conducted on 11-02-2019
Name and address of API manufacturer. M/s Jiangsu Province Qinfen Co,. Ltd.
28 changxing east road, Economic and
Technological Development zone, Nantong
Jiangsu Province.
substance
Real time: Temp.: 30°C ± 2°C, RH: 65%
± 5% for 36 month
Accelerated: Temp.: 40°C ± 2°C, RH: 75%
± 5%for 6 months
Batches: (Na102504, Na104804, Na107905)
product.
Visoline 0.9% injection (B #NPD 912 T-01)
with reference product Celine 0.9% injection
(B #CLN-054B) of M/s Surge Laboratories
Pvt. Ltd. The results showed that both test and
comparator products were comparable.
of product including linearity, range, accuracy,
Manufacturer of API Name: M/s Jiangsu Province Qinfen Co,. Ltd.
Address: 28 changxing east road, Economic and Technological
Development zone, Nantong Jiangsu Province.
API Lot No. 200420
Description of Pack
LDPE ampoule (10ml) packed in unit carton (1’s)
Batch No. NDP 912 T-01 NDP 912 T-02 NDP 912 T-03
Batch Size 5 liters 5 liters 5 liters
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate Copy of GMP certificate No. JS20170729
of API manufacturer issued by concerned issued by China Food & drug Administration
regulatory authority of country of origin. valid till 26/11/2022 is submitted.
3. Documents for the procurement of API The firm has submitted copy of attested ADC
with approval from DRAP (in case of (I&E) DRAP, Islamabad dated 02-07-2020.
import).
4. Data of stability batches will be supported Firm has submitted record of testing of all
by attested respective documents like batches along with
chromatograms, chromatograms, raw data sheets, COA and
Raw data sheets, COA, summary data summary data sheets.
sheets etc.
5. Compliance Record of HPLC software Not Provided
testing
accelerated)
Sr No. Short-Comings Reply from the Firm
a. Details regarding the method and The firm has provided testing reports for
testing reports of Endotoxin tests of the BET.
drug product are required.
You are using LDPE ampoule, which is
a semi-permeable membrane container,
how would you justify the performance
at both accelerated (40’C, 75%) and
real time stability studies (30’C, 65%).
b. You are using LDPE ampoule, which is As per ICH guideline stability testing.
a semi-permeable membrane container, If stability for semi-permeable container
how would you justify the performance performed at (30C, 65% real time stability
at both accelerated (40’C, 75%) and studies and 40C,75% for accelerated, ICH
real time stability studies (30’C, 65%). provide the alternative approach for
calculation of water loss. For example at a
given temperature 40C, the calculated
waterloss during storage at NMT 25%RH is
the water loss rate measured at 75% RH
multiplied by 3, the corresponding water loss
ratio is:
Alternative Reference Ratio of

relative water loss
humidity rates at a
given
temperature.
60%RH 25%RH 1.9
60%RH 40%RH 1.5
65%RH 35%RH 1.9
75%RH 25%RH 3.0
c. Describe the manufacturing facility We will manufacture in Large Volume
along with the section in detail as you parenteral section BFS technology.
have multiple parenteral sections
(General)
Decision: Approved.
410. Name, address of Applicant / M/s Jawa Pharmaceuticals Private
Marketing Authorization Holder Limited
112/10 Quaid-e-Azam Industrial Area Kot
Lakhpat, Lahore,
Lakhpat, Lahore,
☐ Importer
giver)
☐ Export sale
Mfor-Sita Tablets JPL 50mg/1000mg
name
Active Pharmaceutical ingredient (API) Metformin HCL … 1000mg
per unit Sitagliptin as phosphate …50mg
Pharmaceutical form of applied drug Green, oblong shaped, film coated tablet,
embossed "Jawa" on one side-
Pharmacotherapeutic Group of (API) Sitagliptin belongs to a class of medicines
called DPP-4 inhibitors (dipeptidyl
peptidase-4 inhibitors)
Metformin belongs to a class of medicines
called biguanides.
In-House
specifications
The status in reference regulatory Janumet Tablet by Merck Sharp & Dohme
authorities
For generic drugs (me-too status) Janumet Tablet by OBS Pharma
Reg No: 066172
GMP status of the Finished product New license granted on 04-03-2020
manufacturer
Name and address of API manufacturer. Metformin HCL: M/s IPCA Laboratories
Limited, H-4, M.I.D.C., Waluj Aurangabad
(Maharashtra) Pin : 431136, India
Sitagliptin as phosphate: M/s Zhejiang
Yougtai Pharmaceuticals Co., Ltd, No,1,4th
Doughi Zhejiang Provincial and Chemical
and Medical Raw Material Base Linhai Zone,
Linhai City, Zhejiang Province, 317016,
China.
process and controls, container closure
Module III (Drug Substance) Official monograph of Metformin Hcl &
Sitagliptin as phosphate is present in USP.
manufacturing process and controls, ,
of drug substance
months
months
Batches: (Trial 1, Trial 2, Trial 3)
product.
comparative dissolution profile established against the Janumet Tablet by
Merck Sharp & Dohme B.V., Waarderweg
39, 2031 BN Haarlem, The Netherlands
EU/1/08/455/008

Manufacturer of API Metformin HCL: M/s IPCA Laboratories Limited, H-4, M.I.D.C.,
Waluj Aurangabad (Maharashtra) Pin : 431136, India
Sitagliptin as phosphate: M/s Zhejiang Yougtai Pharmaceuticals
Co., Ltd, No,1,4th Doughi Zhejiang Provincial and Chemical and
Medical Raw Material Base Linhai Zone, Linhai City, Zhejiang
Province, 317016, China.
API Lot No. Metformin HCL:20549ML2ARMI
Sitagliptin as phosphate: 2036-0001-20196
Description of Pack Mfro-Sita tablet supplied Alu alu/aluminum foil blister packs as 2 x
(Container closure system) 7`s.
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate
3. Documents for the procurement of API • Copy of letter Ref. No: 1345/2021/DRAP-
with approval from DRAP (in case of AD-VI (I&E) dated 08-05-2020 is
import). submitted wherein the permission to import
different APIs including Metformin Hcl &
Sitagliptin for the purpose of test/analysis
chromatograms,
sheets etc.
5. Compliance Record of HPLC software Did not provided the data.
testing
accelerated)
a. Valid GMP/DML of API
manufacturers are required.
b. In EMA public assessment report,

limits for the assay test for drug
product are 95% - 105% while the
specification of the drug product
provided by the drug product
manufacturer is 90% - 110%.
c. 3.2.S.4 Control of Drug Substance :- A
discussion and justification should be
provided for any incomplete analyses
of the drug substance / API by Drug
Product manufacturer (e.g. results not
tested according to the proposed
specification.
d. 3.2.P.5 Control of Drug Product: - You
have prepared batches without
considering the equivalency factor of
Sitagliptin in master formulation.
Clarification is needed
Lakhpat, Lahore,
Lakhpat, Lahore,
☐ Importer
giver)
☐ Export sale
Mfor-Sita Tablets JPL 50mg/500mg
name
Active Pharmaceutical ingredient (API) Metformin HCL … 500mg
per unit Sitagliptin as phosphate …50mg
Pharmaceutical form of applied drug Green, oblong shaped, film coated tablet,
embossed "Jawa" on one side-
Pharmacotherapeutic Group of (API) Sitagliptin belongs to a class of medicines
called DPP-4 inhibitors (dipeptidyl
peptidase-4 inhibitors)
Metformin belongs to a class of medicines
called biguanides.
In-House
specifications
The status in reference regulatory Janumet Tablet by Merck Sharp & Dohme
authorities
For generic drugs (me-too status) Janumet Tablet by OBS Pharma

manufacturer
Name and address of API manufacturer. Metformin HCL: M/s IPCA Laboratories
Limited, H-4, M.I.D.C., Waluj Aurangabad
(Maharashtra) Pin : 431136, India
Sitagliptin as phosphate: M/s Zhejiang
Yougtai Pharmaceuticals Co., Ltd, No,1,4th
Doughi Zhejiang Provincial and Chemical
and Medical Raw Material Base Linhai Zone,
Linhai City, Zhejiang Province, 317016,
China.
process and controls, container closure
Module III (Drug Substance) Official monograph of Metformin Hcl &
Sitagliptin as phosphate is present in USP.
manufacturing process and controls, ,
of drug substance
months
months
product.
comparative dissolution profile established against the Janumet Tablet by
Merck Sharp & Dohme B.V., Waarderweg
39, 2031 BN Haarlem, The Netherlands
EU/1/08/455/008

Manufacturer of API Metformin HCL: M/s IPCA Laboratories Limited, H-4, M.I.D.C.,
Waluj Aurangabad (Maharashtra) Pin : 431136, India
Sitagliptin as phosphate: M/s Zhejiang Yougtai Pharmaceuticals
Co., Ltd, No,1,4th Doughi Zhejiang Provincial and Chemical and
Medical Raw Material Base Linhai Zone, Linhai City, Zhejiang
Province, 317016, China.
API Lot No. Metformin HCL:20549ML2ARMI
Sitagliptin as phosphate: 2036-0001-20196
Description of Pack Mfro-Sita tablet supplied Alu alu/aluminum foil blister packs as 2 x
(Container closure system) 7`s.
No. of Batches 03
the firm (if any)
import). submitted wherein the permission to
import different APIs including Metformin
Hcl & Sitagliptin for the purpose of
test/analysis and stability studies is
granted.
chromatograms,
sheets etc.
11. Compliance Record of HPLC software Did not provided the data.
testing
accelerated)
Lakhpat, Lahore,
Lakhpat, Lahore,
☐ Importer
giver)
☐ Export sale
J-Pride Tablet 2mg
name
Active Pharmaceutical ingredient (API) Glimepride … 2mg
per unit
Pharmaceutical form of applied drug White colored round, uncoated tablet with
score line on one side & plain on other side
Pharmacotherapeutic Group of (API) Glimepiride belongs to a group called
sulfonylurea works as Inhibition of ATP-
dependent potassium channels treatment of
diabetes mellitus.
In-House
specifications
The status in reference regulatory Glimepiride Tablet by Accord Healthcare
authorities Limited, MHRA
For generic drugs (me-too status) Amaryl 2mg Tablet by Sanofi-Aventis
Reg No: 019568
manufacturer Tablets (general) section approved
Name and address of API manufacturer. M/s Indico Remedies Ltd
R-104, M.I.D.C., T.T.C. Area, Thane Belapur
Road, Rabale, Navi Mumbai — 400 701,
Maharashtra, India.
process and controls, batch analysis and
Module III (Drug Substance) Official monograph of Glimepiride is present
controls, analytical procedures and its
substance
months
months
product.
comparative dissolution profile established against the Amaryl 2mg Tablet by
Sanofi-Aventis.
of product including accuracy, precision, specificity
Manufacturer of API M/s Indico Remedies Ltd
R-104, M.I.D.C., T.T.C. Area, Thane Belapur Road, Rabale, Navi
Mumbai — 400 701, Maharashtra, India.
API Lot No. GLM19012R
Description of Pack J-Pride tablet supplied PVC/aluminum foil blister packs - pack
(Container closure system) sizes of 2 x 10`s.
No. of Batches 03
the firm (if any)
14. Approval of API/ DML/GMP certificate Copy of GMP certificate valid till 07-04-
of API manufacturer issued by concerned 2023 provided
import different APIs including Paroxetine
HCl for the purpose of test/analysis and
chromatograms,
sheets etc.
17. Compliance Record of HPLC software Did not provided the data
testing
accelerated)
e. Valid GMP/DML of API
f. 3.2.S.4 Control of Drug Substance :- A
specification.
g. Justify the dissolution conditions and
criteria of NLT 85% in 15minutes for
the drug product.
h. 3.2.P.5.3:- Specificity parameter has

been performed by injecting the blank,
and standard solution. Whereas USP
chapter <1225> & ICH Q2 (R1)
guidelines suggests spiking the drug
substance with appropriate levels of
impurities. Justification shall be
submitted for this variation
i. Reference of previous approval of
the firm (if any
j. Documents for the procurement of API

import).
k. Compliance Record of HPLC software

testing.
Lakhpat, Lahore,
Lakhpat, Lahore,
☐ Importer
giver)
☐ Export sale
J-Pride Tablet 4mg
name
Active Pharmaceutical ingredient (API) Glimepride … 4mg
per unit
Pharmaceutical form of applied drug White colored round, uncoated tablet with
score line on one side & plain on other side
Pharmacotherapeutic Group of (API) Glimepiride belongs to a group called
sulfonylurea works as Inhibition of ATP-
dependent potassium channels treatment of
diabetes mellitus.
In-House
specifications
The status in reference regulatory Glimepiride Tablet by Accord Healthcare
authorities Limited, MHRA
For generic drugs (me-too status) Amaryl 4mg Tablet by Sanofi-Aventis

manufacturer Tablets (general) section approved
Name and address of API manufacturer. M/s Indico Remedies Ltd
R-104, M.I.D.C., T.T.C. Area, Thane Belapur
Road, Rabale, Navi Mumbai — 400 701,
Maharashtra, India.
process and controls, batch analysis and
Module III (Drug Substance) Official monograph of Glimepiride is present
controls, analytical procedures and its
substance
months
months
product.
comparative dissolution profile established against the Amaryl 4mg Tablet by
Sanofi-Aventis.
of product including accuracy, precision, specificity
Manufacturer of API M/s Indico Remedies Ltd
R-104, M.I.D.C., T.T.C. Area, Thane Belapur Road, Rabale, Navi
Mumbai — 400 701, Maharashtra, India.
API Lot No. GLM19012R
Description of Pack J-Pride tablet supplied PVC/aluminum foil blister packs - pack
(Container closure system) sizes of 2 x 10`s.
No. of Batches 03
the firm (if any)
20. Approval of API/ DML/GMP certificate Copy of GMP certificate valid till 07-04-
of API manufacturer issued by concerned 2023 provided
import different APIs including Paroxetine
HCl for the purpose of test/analysis and
chromatograms,
sheets etc.
23. Compliance Record of HPLC software Did not provided the data
testing
accelerated)
a. Valid GMP/DML of API
b. 3.2.S.4 Control of Drug Substance :- A

specification.
c. Justify the dissolution conditions and
criteria of NLT 85% in 15minutes for
the drug product.
d. 3.2.P.5.3:- Specificity parameter has

been performed by injecting the blank,
and standard solution. Whereas USP
chapter <1225> & ICH Q2 (R1)
guidelines suggests spiking the drug
substance with appropriate levels of
impurities. Justification shall be
submitted for this variation
e. Reference of previous approval of
the firm (if any
f. Documents for the procurement of API

import).
g. Compliance Record of HPLC software
testing.
414. Name, address of Applicant / Marketing M/s W.Woodward Pakistan Private Limited
Authorization Holder Karachi, Pakistan
Name, address of Manufacturing site. M/s W.Woodward Pakistan Private Limited,
F-275, S.I.T.E. Karachi, Pakistan
☐ Importer
giver)
☐ Export sale
Details of fee submitted Rs.20,000/- dated 14-06-2021 & Rs.10,000/-
dated 10-06-2021
Lifo Tablet 5 mg/850mg
name
Active Pharmaceutical ingredient (API) Dapagliflozin propanediol
per unit monohydrate…5mg
Metformin HCl……..850mg
Pharmaceutical form of applied drug Off-white oblong shaped biconvex film
coated tablet
Pharmacotherapeutic Group of (API) Anti-hyperglycemia
Manufacturer’s Specifications
specifications
Proposed Pack size 14’s Tablets
The status in reference regulatory Xingduo tablet by M/s Astra Zeneca ABSF-
authorities 15185 sodertalji Sweden , MHRA
For generic drugs (me-too status) Dapamet Tablet by M/s Hilton Pharma,
Reg. No. 093071
GMP status of the Finished product Last GMP Inspection dated on 14-03-2022
manufacturer concludes that M/s W.Woodward Pakistan
(Pvt) Ltd is considered to be compliance of
good level of GMP .
Name and address of API manufacturer. Dapagliflozin propandiol monohydrate:-
M/s Fuxin Long Rul Pharmaceutical Co.
Ltd. Fluorida Industrial Park, Fumwng
Country (YiMaTu). Fuxin City, Liaoning
Province 123000, China.
Metformin Hydrochloride :-M/s IPCA

Laboratories Ltd, 48, Kandivali Industrial
Estate, Kandivali (West) 400067 Mumbai
Maharashtra India.
Module III (Drug Substance) Official monograph of Dapagliflozin
Propandiol monohydrate is a manufacturer’s
specification. The firm submitted detail of
Official monograph of Metformin
hydrochloride is a USP specification. The
firm submitted detail of nomenclature,
substance
months
months
Batches: (PD-161,PD-162,PD-163)
Module-III (Drug Product): The firm has submitted detail of drug Product
excipients , control of drug product,
Dapamet 5mg/850mg Tablet Hilton Pharma
by performing quality tests (Description,
Dissolution, and, Assay,).
brand that is brand leader that is Dapamet
5mg/850mg Tablet Hilton Pharma in 0.1N
HCl, Acetate buffer pH 4.5, Phosphate Buffer
pH 6.8 and Phosphate buffer pH 7.2. The
range.
of product including linearity, range, accuracy,
Manufacturer of API M/s Fuxin Long Rul Pharmaceutical Co. Ltd. Fluorida Industrial
Park, Fumwng Country (YiMaTu). Fuxin City, Liaoning Province
123000, China.
M/sIPCA Laboratories Ltd, 48, Kandivali Industrial Estate,
Kandivali (West) 400067 Mumbai Maharashtra India.
API Lot No.

Description of Pack
Alu-Alu blister packed in unit carton with leaflet (14’s)
No. of Batches 03
1. Reference of previous approval of Information by the firm did not provided.
the firm (if any)
3. Documents for the procurement of API Firm has submitted copy of letter from M/s
with approval from DRAP (in case of Biofar Chemicals in name of M/s Woodward
import). Pakistan, for provision of 15gm of
Dapagliflozin propanediol monohydrate.
4. Data of stability batches will be supported Firm has submitted record of testing of all
by attested respective documents like batches along with chromatograms, raw data
chromatograms, sheets, COA and summary data sheets
sheets etc.
5. Compliance Record of HPLC software Did not provide.
testing
accelerated)
Decision: Deferred for submission of documents for the procurement of APIs with approval
from DRAP I&E office & compliance record of HPLC software 21CFR & audit trail reports
on product testing
415. Name, address of Applicant / Marketing M/s CITY PHARMACEUTICALS
Authorization Holder LABORATORIES
PLOT # 12-A, I-5 SECTOR 5, NEW
SURVEY No. 276, KORANGI
INDUSTRIAL AREA KARACHI
PAKISTAN
Name, address of Manufacturing site. M/s CITY PHARMACEUTICALS
LABORATORIES
PLOT # 12-A, I-5 SECTOR 5, NEW
SURVEY No. 276, KORANGI
INDUSTRIAL AREA KARACHI
PAKISTAN
☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand EXIT 2 gm powder for solution for injection
name / infusion
Strength / concentration of drug of Each Vial contains: Ceftriaxone sodium
Active Pharmaceutical ingredient (API) Sterile Powder for solution for injection eq.
per unit to Ceftriaxone ………. 2 gm
Pharmaceutical form of applied drug Lyophilized powder for solution for IV

injection or Infusion
Pharmacotherapeutic Group of (API) Cephalosporin antibiotic
USP
specifications
The status in reference regulatory A Ceftriaxone 2 g Powder for Solution for
authorities Injection or Inf by M/s MIP Pharma GmbH
Kirkeler Str. 41 66440 Blieskastel Germany,
MHRA Approved.
For generic drugs (me-too status) INOCEF 2gm Injection by M/s Barrett
Hodgson, Reg. No. 032582
GMP status of the Finished product DML granted on 15/06/2016

manufacturer
Name and address of API manufacturer. Henan Kangda Pharmaceutical Co., Ltd.
No.66 Jingwu Road, Xiangcheng city,
Henan Province, China
of drug substance and drug product is
submitted.
Module III (Drug Substance) Official monograph of Ceftriaxone Sodium
is present in USP. The firm as submitted
substance
months
6 months
analytical procedure (including dissolution
testing at acidic and buffer medium) and its
comparative dissolution profile established against the INOCEF 2gm IV by
BARRET HODGSON PAKISTAN by
Assay, pH).
validation/verification of product including linearity, range, accuracy,
precision, specificty.

Manufacturer of API Henan Kangda Pharmaceutical Co., Ltd.
No.66 Jingwu Road, Xiangcheng city, Henan Province, China.
API Lot No. 2022005028
Description of Pack 30ml round neck Type 3 glass vial with dark grey rubber stopper
(Container closure system) and Aluminium seal (1’s)
Batch No. T-001 T-002 T-003
No. of Batches 03
the firm (if any)
8. Approval of API/ DML/GMP certificate Copy of GMP certificate No. HA20170010
of API manufacturer issued by issued by China FDA valid till 02-16-2022.
country of origin.
9. Documents for the procurement of API • Invoice # YK21063022, Dated 05-12-
with approval from DRAP (in case of 2020 is submitted with ADC approval
import). date 18-12-2020
10. Data of stability batches will be Data of stability batches will be supported
supported by attested respective by attested respective documents like
documents like chromatograms, chromatograms,
Raw data sheets, COA, summary data Raw data sheets, COA, summary data sheets
sheets etc. etc. is Submitted
11. Compliance Record of HPLC software We have maintained manual logs of all
21CFR & audit trail reports on product tests.
testing
12. Record of Digital data logger for Record of Digital data logger for
temperature and humidity monitoring of temperature and humidity monitoring of
stability chambers (real time and stability chambers (real time and
accelerated) accelerated) is submitted
h. 3.2.S.4.3 Analytical Method Submitted by M/s City Pharmaceuticals
Verification studies including Laboratories.
specificity, accuracy and repeatability
(method precision) performed by the
Drug Product manufacturer shall be
submitted.
i. 3.2.S.7 Submit sterility testing reports.
Firm has submitted reports for bacterial
Endotoxin Test for drug substance.
j. 3.2.P.1 Justify the equivalency factor Firm has submitted calculations declaring the
of Ceftriaxone sodium for Ceftriaxone. theoretical factor for the sodium salt.
k. 3.2.P.2 Compatibility studies for the dry Submitted.
powder for injections should be
performed as per the instructions
provided in individual label of the drug
product.
l. 3.2. P.8Microbiological analysis record Submitted.
for the performance of sterility test &
Bacterial Endotoxin test shall be
submitted..
m. Compliance Record of HPLC software --
testing
Decision: Approved.
Item no 3. Stability studies cases on Form 5 D
416. Name and address of manufacturer / M/s Neutro Pharma (Pvt) Ltd. 9.5 km,
Applicant Sheikhupura Road,Lahore
Brand Name +Dosage Form + Strength Etoricoxib 120mg Tablet
Each Film Coated Tablet Contains:
Composition
Etoricoxib……….120mg
Dy.No 41592 dated 07-12-2018 Rs.50,000/-
Diary No. Date of R& I & fee
Dated 07-12-2018
Pharmacological Group (NSAIDs)
Finished product Specifications Manufacturer’s Specifications
Pack size & Demanded Price 10’s, 14’s, 20’s, 28’s, 30’s, (4×7’s); As per SRO
Approval status of product in Etoricoxib 120mg film coated tablet
Reference Regulator Authorities (USFDA Approved)
Me-too status
The last inspection conducted on 18-07-2017
GMP status concluding that the firm maintained a fair level of
GMP compliance
Remarks of the Evaluator Stability data is not provided
Decision of 295th: Deferred for submission of stability studies of 3 batches according to the
conditions of zone IV-A as per the directions given in 278th meeting of Registration Board.
Remarks of the Evaluator:- Firm was asked to provide the stability data on 14points as per the
decision of the registration Board in its 293rd meeting.
M/s AURORE LIFE SCIENCES PVT LTD. Plot # 68, 69, 2nd Floor,
Manufacturer of API Jubilee Heights, beside Shiplaramam, Madhapur, Hyderabad,
Telangana 50008, India.
API Lot No. ETX-60010119
Description of Pack
Real time: 30°C ± 2° C / 65% ± 5%
Accelerated: 40 °C ± 2 °C / 75% ± 5%
Real time: 6th months
Time Period
Accelerated: 6th months
Accelerated: initial, 3rd , 6th (months)
Frequency
Real Time: initial, 3rd , 6th (months)
ETC-FC-120-003-
Batch No. ETC-FC-120-001-19 ETC-FC-120-002-19
19
No. of Batches 03
firm products conducted by the panel, on the basis
of which Registration Board approved Neutro
pharma “Dexlanzoprazol products”
•
16. Certificate of Analysis of API from both API Copies of API (Etoricoxib) COA’s (Batch#
Manufacturer and Finished Product ETX-60010119) from AURORE LIFE
manufacturer. SCIENCES PVT LTD. Plot # 68, 69, 2nd
Floor, Jubilee Heights, beside Shilparamam,
Madhapur, Hyderabad, Telangana 50008,
India and M/s Neutro Pharmaceuticals (Pvt.)
Ltd are submitted.
17. Method used for analysis of API from both Methods used for analysis of API from both
API Manufacturer and Finished Product API Manufacturers and Finished Product
manufacturer API as per zone IV-A. Stability study is
conducted at Real time:- Temp 30°C ± 2°C /
65% ± 5%RH Accelerated:- Temp 40°C ±
2°C / 75% ± 5%RH
Batches #: (50011115, 50021115
,50031115)
19. Approval of API/ DML/GMP certificate of Firm has submitted copy of valid GMP
API manufacturer issued by concerned certificate in the name of M/s AURORE
regulatory authority of country of origin. LIFE SCIENCES PVT LTD. Plot # 68, 69,
2nd Floor, Jubilee Heights, beside
Shiplaramam, Madhapur, Hyderabad,
20. Documents for the procurement of API with The firm has submitted copy of ADC
approval from DRAP (in case of import). attested invoice No. 154 dated 25-02-2019
from exporter M/s AURORE LIFE
SCIENCES PVT LTD. Plot # 68, 69, 2nd
India. For import of 6.0 Kg of Etoricoxib
(Batch No. ETX-60010119) in name of M/s
Neutro Pharmaceuticals (Pvt.) Ltd. Lahore
attested by AD (I&E) DRAP Lahore dated
29-04-2019.
21. Protocols followed for conduction of Protocols followed for conduction of
stability study stability study is submitted
22. Method used for analysis of FPP Method for Finished product analysis has
been submitted
23. Drug-excipients compatibility studies Drug excipients compatibility study
(where applicable) performed.
Batch No. Batch Mfg.
Size Date
ETC-FC-120-001- 1200 tablets 09-2019
19
ETC-FC-120-002- 1200 tablets 09-2019
19
ETC-FC-120-003- 1200 tablets 09-2019
19
(where applicable) against Arcoxia 120mg Tablet Batch #
M045935 in HCl buffer (pH 1.2), Acetate
buffer (pH 4.5) & Phosphate buffer (pH 6.8).
26. Data of 03 batches will be supported by Data of 03 batches will be supported by
attested respective documents like attested respective documents like
chromatograms, Raw data sheets, COA, chromatograms, Raw data sheets, COA,
summary data sheets etc. summary data sheets etc. is submitted
testing.
28. Record of Digital data logger for temperature Record of Digital data logger for
and humidity monitoring of stability temperature and humidity monitoring of
chambers (real time and accelerated) stability chambers (real time and
417. Name and address of manufacturer / M/s Neutro Pharma (Pvt) Ltd. 9.5 km,
Applicant Sheikhupura Road,Lahore
Brand Name +Dosage Form + Strength Etoricoxib 90mg Tablet
Each Film Coated Tablet Contains:
Composition
Etoricoxib……….90mg
Dy.No 41296 dated 07-12-2018 Rs.50,000/-
Diary No. Date of R& I & fee
Dated 07-12-2018
Pharmacological Group (NSAIDs)
Finished product Specifications Manufacturer’s Specifications
Approval status of product in ARCOXIA (30mg, 60mg, 90mg,120mg) film
Reference Regulator Authorities coated tablet by M/s MSD, MHRA Approved.
Me-too status
The last inspection conducted on 18-07-2017
GMP status concluding that the firm maintained a fair level of
GMP compliance.
Remarks of the Evaluator Stability data is not provided
Decision of 295th: Deferred for submission of stability studies of 3 batches according to the
conditions of zone IV-A as per the directions given in 278th meeting of Registration Board.

Remarks of the Evaluator:- Firm was asked to provide the stability data as per the decision of the
registration Board in its 293rd meeting.
M/s AURORE LIFE SCIENCES PVT LTD. Plot # 68, 69, 2nd
Manufacturer of API Floor, Jubilee Heights, beside Shiplaramam, Madhapur, Hyderabad,
API Lot No. ETX-60010119
Description of Pack
Real time: 30°C ± 2° C / 65% ± 5%
Accelerated: 40 °C ± 2 °C / 75% ± 5%
Real time: 6th months
Time Period
Accelerated: 6th months
Accelerated: initial, 3rd , 6th (months)
Frequency
Real Time: initial, 3rd , 6th (months)
Batch No. ETC-FC-90-001-19 ETC-FC-90-002-19 ETC-FC-90-003-19
No. of Batches 03
firm products conducted by the panel, on the basis
of which Registration Board approved Neutro
pharma “Dexlansoprazol products”
•
2. Certificate of Analysis of API from both API Copies of API (Etoricoxib) COA’s (Batch#
Manufacturer and Finished Product ETX-60010119) from AURORE LIFE
manufacturer. SCIENCES PVT LTD. Plot # 68, 69, 2nd
India and M/s Neutro Pharmaceuticals (Pvt.)
Ltd are submitted.
3. Method used for analysis of API from both Methods used for analysis of API from both
API Manufacturer and Finished Product API Manufacturers and Finished Product
manufacturer API as per zone IV-A. Stability study is
conducted at Real time:- Temp 30°C ± 2°C /
65% ± 5%RH Accelerated:- Temp 40°C ±
2°C / 75% ± 5%RH
Batches #: (50011115, 50021115
,50031115)
5. Approval of API/ DML/GMP certificate of Firm has submitted copy of valid GMP
API manufacturer issued by concerned certificate in the name of M/s AURORE
regulatory authority of country of origin. LIFE SCIENCES PVT LTD. Plot # 68, 69,
2nd Floor, Jubilee Heights, beside
Shiplaramam, Madhapur, Hyderabad,
6. Documents for the procurement of API with The firm has submitted copy of ADC
approval from DRAP (in case of import). attested invoice No. 154 dated 25-02-2019
from exporter M/s AURORE LIFE
SCIENCES PVT LTD. Plot # 68, 69, 2nd
India. For import of 6.0 Kg of Etoricoxib
(Batch No. ETX-60010119) in name of M/s
Neutro Pharmaceuticals (Pvt.) Ltd. Lahore
attested by AD (I&E) DRAP Lahore dated
29-04-2019.
7. Protocols followed for conduction of Protocols followed for conduction of
stability study stability study is submitted
8. Method used for analysis of FPP Method for Finished product analysis has
been submitted
9. Drug-excipients compatibility studies Drug excipients compatibility study
(where applicable) performed.
Batch No. Batch Mfg.
Size Date
ETC-FC-90-001- 1200 tablets 08-2019
19
ETC-FC-90-002- 1200 tablets 08-2019
19
ETC-FC-90-003- 1200 tablets 08-2019
19
(where applicable) against Arcoxia 90mg Tablet Batch #
M022039 in HCl buffer (pH 1.2), Acetate
buffer (pH 4.5) & Phosphate buffer (pH 6.8).
12. Data of 03 batches will be supported by Data of 03 batches will be supported by
attested respective documents like attested respective documents like
chromatograms, Raw data sheets, COA, chromatograms, Raw data sheets, COA,
summary data sheets etc. summary data sheets etc. is submitted
testing.
14. Record of Digital data logger for temperature Record of Digital data logger for
and humidity monitoring of stability temperature and humidity monitoring of
chambers (real time and accelerated) stability chambers (real time and

1. For Stability Panel

418. Name and address of manufacturer M/s. NEXT Pharmaceutical Products Pvt. Ltd. Plot# 44 A-
/ Applicant B, Sundar Industrial Estate Lahore.
Brand Name +Dosage Form + Empaglif 10mg Tablets
Strength
Empagliflozin………………..10 mg
Diary No. Date of R& I & fee Dy. No. 41051 dated 06-12-2018 Rs. 20,000 Dated 06-12-2018
Pharmacological Group Anti-Diabetic
Type of Form Form 5
Finished product Specification Manufacturer’s specifications
Pack size & Demanded Price 14, 28, 30 & As per SRO
Approval status of product in MHRA Approved
Me-too status XENGLU 10mg by Hilton Pharma Karachi ( reg # 093065)
GMP status 28-05-2022 Satisfactory level of GMP compliance.
Drug Empaglif 10mg
Name of Manufacturer M/s. NEXT Pharmaceutical Products Pvt. Ltd. Plot# 44 A-B, Sundar Industrial
Estate Lahore
Manufacturer of API M/s Jiangsu Yongan Pharmaceutical Co. Ltd China
API Lot No. 4500-201909001
Description of Pack
Alu-Alu blister
Stability Storage Condition Real Time: 30oC ± 2oC / 65% ± 5%RH
Accelerated:40oC ±2oC / 75% ± 5%RH
Time Period Real Time: 06 Months
Accelerated:06Months
Frequency Real Time: 0,1,3,6
Accelerated: 0,1,3,6 Months
Batch No. T-0001 TAA T-0002 TAA T-0003 TAA
No. of Batches 03
Date of Submission
1. Certificate of Analysis of API from both API The firm has provided copy of GMP certificate
Manufacturer and Finished Product (Certificate# JS 2020921) issued by Jiansu Drug
manufacturer. Administration for M/s Jiangu Yongan Pharmaceutical
Co., Ltd. Valid Up to 14-03-2023
2. Protocols followed for conduction of stability The firm has submitted complete protocol for
study and details of tests.. conduction of stability study and details of tests.
The firm has provided data of 03 batches will be
supported by attested respective documents like
chromatograms, laboratory reports, data
chromatograms, laboratory reports, data sheets
sheets etc
4. Documents confirming import of API etc. Copy of invoice (Invoice No. ZY 19101701G/W ) for
0.5 Kg of Empagliflozin has been submitted attested by
Assistant Director DRAP, Lahore dated 24-10-2019.
5. All provided documents will be attested Submitted

(name, sign and stamp) for ensuring
authenticity of data / documents.
6. Commitment to continue real time stability Submitted
study till assigned shelf life of the product.
Commitment to follow Drug Specification Rules, Submitted
1978.
Brand Name +Dosage Form + DAPGLIF 5mg Tablets
Strength
Dapagliflozin as Propanediol Monohydrate…5mg
Type of Form Form 5
Me-too status DAPA 5mg by Hilton Pharma Karachi ( reg # 089367)
Drug Dapaglif 5mg
Estate Lahore
API Lot No. 7100-201910001
Description of Pack
Alu-Alu blister
Batch No. T-0001 TAE T-0002 TAE T-0003 TAE
No. of Batches 03
Date of Submission
sheets etc
0.5 Kg of Dapagliflozin Propanediol Monohydrate has
been submitted attested by Assistant Director DRAP,
Lahore dated 24-10-2019.
1978.
Brand Name +Dosage Form + DAPGLIF 10mg Tablets
Strength
Dapagliflozin as Propanediol Monohydrate…10mg
Type of Form Form 5
Me-too status DAPA 10mg by Hilton Pharma Karachi ( reg # 089368)
Drug Dapaglif 10mg
Estate Lahore
API Lot No. 7100-201910001
Description of Pack
Alu-Alu blister
Batch No. T-0001 TAF T-0002 TAF T-0003 TAF
No. of Batches 03
Date of Submission
sheets etc
0.5 Kg of Dapagliflozin Propanediol Monohydrate has
been submitted attested by Assistant Director DRAP,
Lahore dated 24-10-2019.
1978.
Inspection Report
1.1 General Information.
Name of Manufacturer M/s Next Pharmaceuticals (Pvt.) Ltd.

Physical Address Plot No. 44 A-B, Sundar Industrial Estate,
Lahore.
Drug Manufacturing License No. and 000 by way of formulation
validity Valid till .
Contact Address Plot No. 44 A-B, Sundar Industrial Estate,
Lahore.
Date of Inspection. 14-06-2021
Purpose of Inspection Verification of Authenticity of Stability Data
for Purpose of Registration of Drugs with
reference DRAP’s letter No. F.15-1/2022-
PEC(AD-PEC-VI) dated 16th August, 2022.
Name of Inspector 01 Mr. Iftikhar Chaudhry,
Member, Registration Board.
03. Ms. Ufaq Tanveer
AD, DRAP, Lahore
Name of firm Representatives
1.2 Focus of Inspection:
The inspection was focused on a thorough evaluation of data for stability studies of following
products namely:
Sr. No. Name / Composition of Drugs

01 Empaglif 10mg Tablets
Each Film Coated tablet contains:
Empagliflozin….. 10mg
02 Dapaglif 10mg Tablet
Dapagliflozin……10mg
03 Dapaglif 5mg Tablet
Dapagliflozin……5mg
Detail of investigation:
Q.no. Observation by Panel

Questions
1. Do you have documents confirming the The firm has imported Dapagliflozin and
import Dapagliflozin and Empagliflozin API Empagliflozin from Jiangsu Yongan
including approval from DRAP? Pharmaceutical Co. Ltd. China, Supplier
Suzhou Zhiyu Biotechnology Co. Ltd. China.
Invoice No. ZY19101701G/W dated 17-10-
2019. Batch # 7100-201910001 and 4500-
201909001. The total quantity purchased was
500 g each. the approval from DRAP is
available vide letter no. 10998/2019/DRAP-
AD-CD(I&E).
2. What was the rationale behind selecting the Rationale behind selecting the particular
particular manufacturer of API? manufacturer of API as informed by the firm
is that the manufacturer is GMP complaint
and vendor evaluation had been done.
3. Do you have documents confirming the The working standard was imported through
import of Dapagliflozin and Empagliflozin Jiangsu Yongan Pharmaceutical Co. Ltd.
reference standard and impurity standards? China. Batch # 7100-201901001(ws) for
Dapagliflozin and Batch No. 4500-
201901001 (WS) for Empagliflozin with
quantity 100mg each.
4. Do you have certificate of Analysis of the The firm has COAs for API and Working
API, reference standards and impurity Standard.
standards?
5. Do you have GMP certificate of API The firm has GMP certificate of API
manufacturer issued by regulatory authority manufacturer issued by Jiangsu Food and
of country of origin? Drug Administration China. Certificate No.
JS20160548 dated. 4-3-2016.
6. Do you use API manufacturer method of The firm had used manufacturer’s method
testing for testing API? for testing the API.
7. Do you have stability studies reports on API? The firm had manufacturer’s stability study
reports of the API.
8. If yes, whether the stability testing has been Yes, stability had been performed as per SIM
performed as per SIM method and Method and Degradation products had been
degradation products have been quantified? quantified by API manufacturer.
9. Do you have method for quantifying the The Firm had not performed quantification
impurities in the API? of the impurities.
10. Do you have some remaining quantities of the The Firm had some remaining quantities of
API, its reference standard and impurities API and Working Standard for reference.
standards?
11. Have you used pharmaceutical grade The firm had used pharmaceutical grade
excipients? excipients as per available documents.
12. Do you have documents confirming the The firm had necessary documents
import of the used excipients? confirming the import of excipients.
13. Do you have test reports and other records on The firm had certificates of analysis and
the excipients used? other record of excipients used.
14. Do you have written and authorized protocols The firm had written protocol for the
for the development of Dapagliflozin and development of Dapagliflozin 10mg Tablet,
Empagliflozin as Tablet? Dapagliflozin 5mg and Empagliflozin 10mg
Tablets.
15. Have you performed Drug-excipients The firm had not performed compatibility
compatibility studies? studies because the composition of their
product is similar to that of the innovator’s
product (Forxiga Tablet for Dapagliflozin
and Jardiance 10mg Tablets for
Empagliflozin) as informed by the firm.
16. Have you performed comparative dissolution Yes. The firm had performed comparative
studies? dissolution studies.
17. Do you have product development (R&D) The firm had separate product development
section? (R&D) section.
18. Do you have necessary equipment’s available The firm had all necessary equipment in
in product development section for Product development section for the
development of Dapagliflozin and development of Dapagliflozin 10mg and
Empagliflozin tablet? 5mg Tablet and Empagliflozin 10mg Tablet.
However, the compression machine was not
available in this section. So the compression
was performed in Tablet Section of
Production area.
19. Are the equipment’s in product development All the equipment’s in Product Development
section qualified? Section was qualified.
20. Do you have proper maintenance / calibration The firm had proper maintenance and
/ requalification program for the equipment calibration for the equipment’s used in
used in PD section? product development section.
21. Do you have qualified staff in product The firm had qualified staff for the
development section with proper knowledge development of product in product
and training in product development? development Section.
22. Have you manufactured three stability batches for the stability studies of Dapagliflozin and
Empagliflozin tablet as required?
The firm had manufactured three stability Dapagliflozin 10mg

batches of Dapagliflozin 5mg & 10mg Tablet Batch # Mfg. Date Exp. Date
and three stability batches of Empagliflozin
10mg Tablet. T- 22-01- 21-01-
0001TAF 2020 2022
T- 11-02- 10-02-
0002TAF 2020 2022
T- 11-02- 10-02-
0003TAF 2020 2022
Dapahgliflozin 5mg
Batch # Mfg. Date Exp. Date
T- 21-01- 20-01-
0001TAE 2020 2022
T- 17-02- 16-02-
0002TAE 2020 2022
T- 17-02- 16-02-
0003TAE 2020 2022
Empagliflozin 10mg
Batch # Mfg. Date Exp. Date
T- 17-01- 16-01-
0001TAA 2020 2022
T- 11-02- 10-02-
0002TAA 2020 2022
T- 11-02- 10-02-
0003TAA 2020 2022
23. Do you have any criteria for fixing the batch The firm had written sop for fixing the
size of stability batches? stability batch size as per number of testing.
24. Do you have complete record of production of The firm had complete record of production
stability batches? of stability batches. All the BPR’s and log
books were properly maintained and
reviewed at the time of inspection.
25. Do you have protocols for stability testing of The firm had protocols for testing of stability
stability batches? batches.
26. Do you have developed and validated the Yes, the firm had developed and validated
method for testing of stability batches? the method for testing of stability batches.
27. Do you have method transfer studies in case Method transfer studies was not performed,
when the method of testing being used by as the firm had developed In-House Method
your firm is given by any other lab? of testing and validation
28. Do you have documents confirming the Yes, the firm has proper documents
qualification of equipment’s / instruments confirming the qualification of equipment
being used in the test and analysis of and instruments being used in the test and
Dapagliflozin and Empagliflozin API and the analysis of API and Finished Product.
finished drug?
29. Does your method of analysis stability Yes, the method of analysis is stability
indicate? indicating.
30. Do your HPLC software 21CFR Compliant? Yes, the HPLC software is 21CFR
compliant.
31. Can you show Audit trail reports on The firm showed the audit trail reports on
Dapagliflozin and Empagliflozin testing? API testing and finished product testing.
32. Do you have some remaining quantities of The firm had remaining quantities of stability
degradation products and stability batches? batches.
33. Do you have stability batches kept on stability Yes, the firm have few packs available,
testing? however stability study had been completed
for 24 months.
34. Do you have valid calibration status for the Yes, the firm has valid calibration status for
equipment’s used in Dapagliflozin and the equipment used in production and
Empagliflozin tablet production and analysis? analysis of Dapagliflozin 5mg and 10mg
Tablets and Empagliflozin 10mg Tablets.
35. Do proper and continuous monitoring and Continuous monitoring and controls were
control are available for stability chamber? available for stability chambers.
36. Do related manufacturing area, equipment, GMP certificate issued by DRAP was
personnel and utilities be rated as GMP available with validity.
compliant?
CONCLUSION:
Based on the documents reviewed, areas inspected and technical personnel met, and considering
the findings of the inspection, the panel is of the view that stability studies were conducted by the firm
M/S Next Pharmaceuticals (Pvt.) Ltd, Lahore for Dapa 10mg, Dapa 5mg and Empa 10mg Tablets.
Decision of 322nd meeting:
• Registration Board decided to approve the applications of Empaglif 10mg Tablets, Dapglif
5mg Tablets & Dapglif 10mg Tablets with Innovator’ specifications.
specifications for each product as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-
2021.
Item No. XII: Agenda of Assistant Director PE&R (Mr. Muhammad Zubair)
421. Name, address of Applicant / Marketing M/s Winbrains Research Laboratories Plot
Authorization Holder No.69/1 Block B, Phase I-II, Industrial Estate,
Hattar Pakistan
Name, address of Manufacturing site. M/s Winbrains Research Laboratories Plot
No.69/1 Block B, Phase I-II, Industrial Estate,
Hattar Pakistan
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Lunaz 1% Cream
Strength / concentration of drug of Active Each Gm Contains:
Pharmaceutical ingredient (API) per unit Luliconazole (In-House)…10 mg
(Product complies Innovator’s Specs)
Pharmaceutical form of applied drug Off white to light yellow cream
Pharmacotherapeutic Group of (API) SSRI (Anti-depressant)
The status in reference regulatory authorities Luzu 1% Japan
For generic drugs (me-too status) Not Available
GMP status of the Finished product Copy of GMP Certificate No. F. 3-20/2019-
manufacturer DRAP-40 dated 03-06-2019
Name and address of API manufacturer. FLAX LABORATORIES
B-29/1, MIDC MAHAD, BIRVADI VILLAGE,
DIST-RAIGAD, MAHARASHTRA, INDIA.
Module III (Drug Substance) Official monograph of Paroxetine Hydrochloride
is present in USP. The firm as submitted detail of
months
months
Batches: (T-09, T-10, T-11)
Pharmaceutical equivalence and comparative Not Applicable
dissolution profile
specificity.

Manufacturer of API FLAX LABORATORIES
B-29/1, MIDC MAHAD, BIRVADI VILLAGE, DIST-RAIGAD,
MAHARASHTRA, INDIA.
API Lot No. 5301-20-029
Description of Pack
Stability storage condition Real time: 30°C ± 2°C / 65% ± 5%RH
Real Time: 0, 3, 6, 9, 12, 24 (Months)
Batch Size 500 Tube 500 Tube 500 Tube
No. of Batches 03
2. Approval of API/ DML/GMP certificate of Provided

wherein the permission to import different APIs
including Paroxetine HCl for the purpose of
• DHL No.XMLPI6.2/90-1504 dated 22/07/2020
chromatograms,
etc.
Observations Response of Firm
Submit valid GMP certificate as provided is expired. Not Submitted
Clarification regarding mentioning Route of administration as oral instead of Corrected as
topical. Topical
Approval/ GMP Certificate of API manufacturing facility issued by relevant Not Submitted
regulatory authority.
Reference of public assessment report is not provided while it is mandatory for Not Submitted
non-pharmacopoeial products.
API specifications provided by drug substance manufacturer are not readable. Provided
Summary of verification of analytical procedures for drug substance is not Provided
provided.
Container closure system is indicating 15 g Cream while applied product is 60g Corrected
cream.
Section 1.5.10 indicates pre-printed Aluminum tube while container closure Pre-printed
system in 3.2.P.1 (d) indicates polypropylene dispenser tube. Aluminium Tube is
confirmed.
Cetyl Alcohol, All-rac-α-tocopherol, liquid paraffin, White soft paraffin and Corrected as Typo
Potassium Sorbate are indicated as excipients while these excipients are not error
mentioned in 2.3.P.1(b).
Formulation Development is not provided. Formulation
development is not
provided.
Maximum holding time of bulk before final packing is not submitted Not Provided.
In process validation protocol, Appearance is mentioned as Off white to light Not Provided.
yellow cream while in product specification appearance is as Clear Colourless
cream.
Test to check the amount of S enantiomer is not included in drug product Not Performed.
specifications while it is being performed by the Innovator.
Justification of non-applicability of Characterization of Impurities. Not Provided.
Justification of specifications is not provided. Not Provided.
Calrification of different Drug substance manufacturer in Module-II & Module- Corrected
III.
COA of drug substance from drug substance manufacturer is not provided. Provided report
indicates results
from both API
manufacturer &
FPP manufacturer.
Stability data of drug substance is not readable. Provided.
pH, Viscosity and Particulate Matter is not tested during Pharmaceutical pH & Viscosity
Equivalence. tests are provided.
Provided data is for oral dosage form instead of topical dosage form. Provided
Information regarding Physicochemical and Biological properties is not provided Not Provided
Justification of critical steps of manufacturing process is not provided. Provided
Process Validation protocol indicates Sifting, Melting, Milling, Congealing & Not Provided
Cooling as processing steps while these steps are not indicated in description of
manufacturing process & flow diagram.
Justification of not performing Identification & Particulate matter tests during The firm submitted
stability studies. that HPLC is not
Compliance record of HPLC software 21CFR & audit trail reports on product 21CFR compliant.
testing. Rest are not
Record of Digital data logger for temperature and humidity monitoring of provided.
Clarification of 24 months demanded shelf life while Innovator has shelf life of
18 months.
which have not been replied earlier, within six months.
422. Name, address of Applicant / Marketing M/s Jaskan Pharmaceutical (Pvt.) Ltd.,
Authorization Holder Plot No. 50, Sunder Industrial Estate, Lahore
Name, address of Manufacturing site. M/s Jaskan Pharmaceutical (Pvt.) Ltd.,
Plot No. 50, Sunder Industrial Estate, Lahore
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Clarkan 500mg Tablet
Strength / concentration of drug of Active Each film coated Tablet Contain:
Pharmaceutical ingredient (API) per unit Clarithromycin..……….500mg
Pharmaceutical form of applied drug Tablet Oral
Pharmacotherapeutic Group of (API) Macrolide Antibiotics
Reference to Finished product specifications USP (United States Pharmacopoeia)
Proposed Pack size 1x 10’s
The status in reference regulatory authorities Clarithromycin 500mg film-coated tablets of M/s
Red Knights Pharma Ltd., UK
For generic drugs (me-too status) Macrocid 500mg Tablet of M/s Don Valley
Pharmaceuticals (Pvt.) Ltd., Lahore Reg. No.
101872
GMP status of the Finished product cGMP No. 10/2021-DRAP (FID-797667-1346)
manufacturer dated 18-02-2021 issued by DRAP.
DML renewal granted by Licensing Division w.e.f.
26-03-2019.
Name and address of API manufacturer. M/s Nexchem Pharmaceutical Co., Ltd. No. 1318
Jinsha street, Linjiang industrial zone, Wucheng
Area, Jinhua city, Zhejiang Province, China.
Module III (Drug Substance) Official monograph of Clarithromycin is present in
months
Batches: (1304-509-FP018, 1304-509-FP020,
1304-509-FP022)
months
Batches: (1105-509-FP006, 1105-509-FP007,
1105-509-FP008)
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence established vis-à-
dissolution profile vis the brand leader, KLARICID Tablet 500mg
by M/s Abbott Laboratories (Pakistan) Ltd by
performing quality tests the results of all the
tests of both products fall within the
specifications and are comparable. The firm has
performed comparative analyses with
innovator’s product. The studies demonstrate
comparable results with the innovator product.
Jaskan Pharmaceuticals has been performed
against the same brand that is KLARICID
Tablet 500mg by Abbott Laboratories
(Pakistan) Ltd in Acid media (pH 1.0-1.2) &
Analytical method validation/verification of Firm has submitted reports of verification studies
product of analytical method for the drug substance.
Manufacturer of API M/s Nexchem Pharmaceutical Co., Ltd. No. 1318 Jinsha street, Linjiang
industrial zone, Wucheng Area, Jinhua city, Zhejiang Province, China.
API Lot No. 2006-5091-ws03
Description of Pack
Blister Pack of PVC and Aluminum print Foil.
Real Time: 0, 3 (Months)
Batch No. CL 01 CL 02 CL 03
No. of Batches 03
1. Reference of previous approval of applications Not Submitted.
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. ZJ20160068 dated
API manufacturer issued by concerned 06-07-2016 issued China Food And Drug
3. Documents for the procurement of API with Not Submitted.


5. Compliance Record of HPLC software 21CFR Not Submitted.
i. 1.5.4 Submit proposed pack size.
ii. 1.5.20 (a) & (b) Submit the undertakings.
iii. 1.6.5 Submit valid Good Manufacturing Practice (GMP) certificate of the Drug Substance
manufacturer issued by relevant regulatory authority of country of origin as submitted is expired.
iv. 3.2.S.1.3 Submit clarification of difference in pH from pharmacopoeia monograph.
v. 3.2.P.2 Submit justification of non-applicability of compatibility studies of drug substance with
excipients.
vi. 3.2.P.2 Submit information regarding key physicochemical characteristics of drug substance that can
influence the performance of drug product.
vii. 3.2.P.2 Submit brief about choice of excipients, their concentrations and characteristics that can
influence drug product performance.
viii. 3.2.P.2 Submit clarification of not performing Loss on Drying (LOD) test during Pharmaceutical
Equivalence study.
ix. 3.2.P.2 Submit the Comparative dissolution profile (CDP) conducted in three BCS media across the
physiological pH range along with calculation of similarity factor f2 as submitted CDP is in only one
media.
x. 3.2.P.5 Submit clarification regarding not including Loss on Drying (LOD) test in finished product
specification while it is included in pharmacopoeia monograph.
xi. 3.2.P.5 Submit detailed analytical procedures used for testing the drug product.
xii. 3.2.P.6 Submit COA of primary / secondary reference standard.
xiii. 3.2.P.8 Submit clarification of different lot no. in COA & stability data sheet.
xiv. 3.2.P.8 Submit clarification of Relative Humidity (RH) condition of 60%±5% instead of 65%±5%
xv. 3.2.P.8 Submit results of accelerated & real time stability data of 03 batches of the products for 06
months.
xvi. 3.2.P.8 Submit justification of batch size of 1666 tablets for stability studies.
xvii. Submit documents for the procurement of API with approval from DRAP (in case of import).
xviii. Submit compliance record of HPLC software 21CFR & audit trail reports on product testing.
xix. Submit clarification as Record of Digital data logger for temperature and humidity monitoring of
stability chambers (real time and accelerated) indicates that temperature of the chamber got out of the
limit of 30°C ± 2°C at multiple points.
within six months.
423. Name, address of Applicant / Marketing M/s Honig Pharmaceutical Laboratories,
Name, address of Manufacturing site. M/s Honig Pharmaceutical Laboratories, 14 km
Adyala Road, Rawalpindi.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Faximin 550 mg tablets.
Strength / concentration of drug of Active Each Film coated tablet contains.
Pharmaceutical ingredient (API) per unit Rifaximin………..550mg
Pharmaceutical form of applied drug Oral solid dosage form

Pharmacotherapeutic Group of (API) Rifaximin is a structural analog of rifampin and a
non-systemic, gastrointestinal site-specific
antibiotic
Reference to Finished product specifications BP Spec’s
Proposed Pack size 1X10’s
The status in reference regulatory authorities MHRA Approved, Targaxan 550 mg tablet by
NORGINE,
Norgine House, Widewater Place, Moorhall Road,
Harefield, Middlesex, UB9 6NS.
For generic drugs (me-too status) Rifaxa

(Rifaximin... 550 mg ) FEROZSONS
Laboratories limited
XIFAXA
550 mg TABLETS (Rifaximin... 550 mg)
BROOKS. Pharma
GMP status of the Finished product Not Provided.
manufacturer
Name and address of API manufacturer. AURORE Life sciences (Pvt) Ltd., Jubilee
Enclave, HITEC City, Hyderabad, Telangana
500081, India.
Module-II (Quality Overall Summary) Firm has not completely filled QOS as per WHO
QOS-PD template.
Module III (Drug Substance) Official monograph of Rifaximin 550 mg tablets is
present in BP. The firm as submitted detail of
specifications, batch analysis and justification of
Stability studies (Drug Substance) Stability study conditions:
months
months
Batches: Accelerated (RMC0010718,
RMC0010720, RMC0010719)
Real time (RMC0010718, RMC0010716,
RMC0010719)
(including BET, testing) and its verification
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence has been established
dissolution profile against the FOXAMINE tablet by CCL Pharma by
performing quality tests (Identification, Assay, pH,
Sterility, BET, Uniformity of dosage form, and
Clarity of product).
The results of Products are found equivalent to that
of results of competitor product as well as with
limit found in official pharmacopeia.
product including linearity, accuracy, precision, specificity.

Manufacturer of API AURORE Life sciences
API Lot No. RMC0010718
Description of Pack
ALU ALU BLISTER PACK OF 10 TABLETS.
Batch No. T-001 T-002 T-003
Batch Size 5000 Packs 5000 Packs 5000 Packs
No. of Batches 03
1. Reference of previous approval of N/A
firm (if any)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. IMC 20190118
API manufacturer issued by concerned issued by CFDA valid till 14/21/2023.
3. Documents for the procurement of API with • Sample Invoice No JTRF210604-MQ dated
approval from DRAP (in case of import). June 8 2018, DRA letter 1824 Dated 22.06.18,
Form 5 No 1042 Dated 22.06.18
4. Data of stability batches will be supported by Stability supporting Data documents including
attested respective documents like chromatograms, Raw data sheets, COA, summary
chromatograms, data sheets Submitted.
etc.
5. Compliance Record of HPLC software 21 CFR Compliance Certificate for Lab Solution-
21CFR & audit trail reports on product testing Shimadzu Submitted.
6. Record of Digital data logger for temperature Real and Accelerated Data Logger Record
and humidity monitoring of stability chambers Submitted.
i. 1.3.4 Submit copy of valid DML
ii. 1.3.5 Submit GMP inspection report/ GMP certificate of the manufacturing unit issued within the
last three years.
iii. 1.5.20 submit the commitment/ undertaking.
iv. 1.6.5 Information is not submitted.
v. QOS on WHO Template or template approved in 293rd meeting having data in light of Guidance
document for submission of application on Form 5-F (CTD) for registration of pharmaceutical Drug
products for human use.
vi. 3.2.S.3 Submit list of API related & process related impurities with their acceptance limit.
vii. 3.2.S.4.1 Description & Color of powder is different from official Pharmacopoeia monograph.
viii. 3.2.S.4.1 Solubility in methanol is not included in specifications while it is mentioned in BP
monograph.
ix. 3.2.S.4.1 Assay limit is mentioned as Min. 99.91% while in BP monograph it is 97%-102%.
x. 3.2.S.4.2 Submit detailed analytical procedures for the testing of drug substance.
xi. 3.2.S.4.3 Submit Analytical Method Verification studies including specificity, accuracy and
repeatability (method precision) performed by the Drug Product manufacturer.
xii. 3.2.S.4.4 Batch size is different in COA of drug product manufacturer than from Batch Size in COA
of API Manufacturer.
xiii. 3.2.S.5 Submit COA of reference standard.
xiv. 3.2.S.7.3 Submit reason of not performing related substance test during stability studies.
xv. 3.2.S.7.3 Submit clarification of similar results of all the tests performed during accelerated stability
studies for all the batches at all time points.
xvi. 3.2.S.7.3 Submit clarification of different batches in real time & accelerated stability studies.
xvii. 3.2.P.1 Submit the description of dosage form as per CTD guidance document.
xviii. 3.2.P.2 Submit Brief on Pharmaceutical Development including discussion on Critical Quality
Attributes (CQAs) & Critical Process Parameters (CPPs)
xix. 3.2.P.2 Maximum holding time of bulk before final packing is not submitted
xx. 3.2.P.2 Submit compatibility studies of drug substance with excipients which are not similar to
Innovator product.
xxi. Submit clarification of indicating different Pharmacopoeia references in different sections of dossier.
xxii. 3.2.P.2 Submit USP monograph of Rifaximin Tablet.
xxiii. 3.2.P.2 Submit clarification of not performing comparative dissolution profile (CDP) with Innovator
product.
xxiv. 3.2.P.2 Clarification of using 75RPM speed in CDP while as per BP monograph it should be 50RPM.
xxv. 3.2.P.2 Clarification is required as value of similarity factor f2 is less than 50 in phosphate buffer pH
4.5 media.
xxvi. 3.2.P.2 Submit clarification of similar results of dissolution profile for all the batches at all time
points.
xxvii. 3.2.P.3 Submit clarification as manufacturing process flow chart in process validation protocol is for
capsule while instant application is of Tablet.
xxviii. 3.2.P.3 Justification of submitting only Compression process validation protocol while other steps
are also involved in manufacturing process.
xxix. 3.2.P.3 Submit clarification as Compression process validation protocol does not specify the speed
for which validation is done.
xxx. 3.2.P.5 Clarification of different specifications of the product from official pharmacopoeia
monograph.
xxxi. 3.2.P.6 Submit COA of reference standard.
xxxii. 3.2.P.8 Testing frequency is not correct in post-approval stability protocol.
xxxiii. 3.2.P.8 Submit results of accelerated & real time stability data of 03 batches of the products as per
CTD guidance document.
xxxiv. Approval of API manufacturing facility by regulatory authority of country of origin
xxxv. Documents for the procurement of API with approval from DRAP (in case of import).
xxxvi. Compliance record of HPLC software 21CFR & audit trail reports on product testing.
xxxvii. Record of Digital data logger for temperature and humidity monitoring of stability chambers (real
time and accelerated).
within six months.
424. Name, address of Applicant / M/s Ophth Pharma (Pvt) Ltd,

Marketing Authorization Plot No. 241, Sector 24, Korangi Industrial
Holder Area,Karachi.
Name, address of Manufacturing M/s Ophth Pharma (Pvt) Ltd,
site. Plot No. 241, Sector 24, Korangi Industrial
Area,Karachi.
☐ Importer
Details of fee submitted PKR 50,000/- dated 19-01-2021
Mydraine Intracameral Injection
brand name
Strength / concentration of drug Each ml contains:
of Active Pharmaceutical Tropicamide……..0.2mg
ingredient (API) per unit Phenylephrine HCl……….3.1mg
Lidocaine HCl……..10mg
Clear, Colorless Aqueous Solution
drug
Anticholinergic
(API)
Manufacturer’s Specifications
specifications
Proposed Pack size 20 x 0.6ml
Proposed unit price Not Provided.
The status in reference regulatory Mydrane 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml solution for
authorities injection by M/s Laboratoires Thea, France MHRA
Approved. Also approved in France & Germany.
For generic drugs (me-too status) Not Provided.
GMP status of the Finished M/s Ophth Pharma (Pvt.) Ltd.,
product manufacturer Copy of GMP certificate No. 121/2020-DRAP(K) dated
02-10-2020 issued on the basis of inspection conducted
on 27-09-2019
Name and address of API Tropicamide
manufacturer. M/s Medigraph Pharmaceuticals Pvt. Ltd.,
Plot No. J-46/57, M.I.D.C., Taloja Dist. Raigad,
Maharashtra 410208, India.
Phenylephrine HCL:
M/s Aarti Industries Limited,
Unit-IV, Plot No. E-50, MIDC, Tarapur, Taluka &
District- Palghar, Pin-401506, Maharashtra, India.
Lidocaine HCl:
M/s Gufic Bioscience Limited,
National Highway No. 8, Noor Grid, Al Post Kabilpore-
396 242, Dist Navsan (Gujarat), India.
submitted.
Module III (Drug Substance) The firm has submitted detail of nomenclature, structure,
Tropicamide:
Batches: PB/TD/007/07/10, PB/TD/008/07/10,
PB/TD/009/07/10.
Phenylephrine HCl:
Batches: PEP(U)/II/1107/51/055,
PEP(U)/II/1107/51/056, PEP(U)/II/1107/51/057.
Lidocaine HCl:
Batches: 1159, 1160, 1161.
Module-III (Drug Product): The firm has submitted data of drug product including its
control, control of excipients, control of drug product.
Specifications, analytical procedures, verification of
comparative dissolution profile equivalence for their product against the Mydrane 0.2
mg/ml + 3.1 mg/ml + 10 mg/ml solution for injection by
M/s Laboratoires Thea, France. The results of all the tests
of both products falls within the specifications and are
comparable.
Analytical method Method verification studies have been submitted
validation/verification of product including accuracy, precision, specificity, repeatability,
linearity.
Manufacturer of API Tropicamide
M/s Medigraph Pharmaceuticals Pvt. Ltd.,
Plot No. J-46/57, M.I.D.C., Taloja Dist. Raigad, Maharashtra 410208,
India.
Phenylephrine HCL:
M/s Aarti Industries Limited,
Unit-IV, Plot No. E-50, MIDC, Tarapur, Taluka & District- Palghar,
Pin-401506, Maharashtra, India.
Lidocaine HCl:
M/s Gufic Bioscience Limited,
National Highway No. 8, Noor Grid, Al Post Kabilpore-396 242, Dist
Navsan (Gujarat), India.
API Lot No.
Description of Pack
Glass Ampoule
Frequency Accelerated: 0,3,6 months
Real Time: 0,3,6 months
Batch No. TB-101 TB-102 TB-103
No. of Batches 03
2. Approval of API/ DML/GMP Not Submitted.
3. Documents for the procurement of Not Submitted.
case of import).
data sheets etc.
5. Compliance Record of HPLC Not Submitted.
i. Fee as per relevant SRO is required.
ii. 1.5.1 Submit information as per CTD guidance document.
iii. 1.5.2 Submit information as per CTD guidance document.
iv. 1.5.4 Submit proposed MRP
v. 1.5.5 Submit Pharmacotherapeutic groups of APIs.
vi. 1.5.6 Submit Pharmacopoeial Reference of applied formulation
vii. 1.5.8 Submit information as per CTD guidance document.
viii. 1.5.10 Submit information as per CTD guidance document.
ix. 1.5.20 Submit the undertakings.
x. 2.3.S Submit QOS for all the APIs as per CTD guidance document.
xi. 3.2.S.3 Submit information as per CTD guidance document for all the APIs.
xii. 3.2.S.4 Submit clarification as melting point mentioned in physicochemical properties is 960C
-1000C which is different from BP monograph.
xiii. 3.2.S.4 Submit clarification as solubility mentioned in physicochemical properties is different
from BP monograph.
xiv. 3.2.S.4 Submit detailed analytical procedures for the testing of all the APIs.
xv. 3.2.S.4 Submit Analytical Method Verification studies including specificity, accuracy and
repeatability (method precision) performed by the Drug Product manufacturer for all the APIs.
xvi. 3.2.S.4 Submit clarification as batch no. is not indicated in COAs of all the APIs of drug product
manufacturer.
xvii. 3.2.S.4 Submit clarification of difference in limit of optical rotation in batch analysis (-42.0o to
-47.5o) and in USP monograph (-43.0o to -47o) of Phenylephrine HCL.
xviii. 3.2.S.4 Submit clarification of difference in limit of Assay in batch analysis & stability studies
(97.5% to 102.5%) from USP monograph (98%-102%) of Phenylephrine HCL.
xix. 3.2.S.4 Submit clarification of difference in limit of Impurities in batch analysis and in USP
monograph of Phenylephrine HCL.
xx. 3.2.S.5 Submit COA of primary / secondary reference standard including source and lot number
for all the APIs.
xxi. 3.2.S.6 Submit Description of the container closure system(s) for the shipment and storage of
all the APIs including materials of construction of each primary packaging component.
xxii. 3.2.S.7 Submit clarification of difference in limit of Impurity A in batch analysis (NMT 0.15%)
and in stability study of Tropicamide (NMT 0.2%)
xxiii. 3.2.P.2 Submit clarification as in excipient compatibility studies, the theoretical contents of
Tropicamide are mentioned as 0.1mg/ml while as per composition, it is 0.2mg/ml.
xxiv. 3.2.P.2 Submit clarification that how %age recovery of Lidocaine HCl in excipient
compatibility studies is 100.2%, 99.8% & 101.0% while the theoretical contents of
Tropicamide are mentioned as 10mg/ml and actual contents are mentioned as 5.01, 4.99 &
5.05.
xxv. 3.2.P.2 Submit brief discussion for the key physicochemical characteristics (e.g. water content,
solubility, particle size distribution, polymorphic or solid state form) of the APIs that can
influence the performance of the Drug Product.
xxvi. 3.2.P.2 Submit detailed procedure used to test assay equivalence and release equivalence in
Pharmaceutical Equivalence Studies.
xxvii. 3.2.P.3 Submit detailed manufacturing process indicating step numbers.
xxviii. 3.2.P.3 Submit the details of critical steps and points at which process controls, intermediate
tests or final product controls are conducted along with tests and acceptance criteria (with
justification, including experimental data).
xxix. 3.2.P.3 Submit a brief description of process validation including the proposed protocolalong
with commitment to perform process validation on first three consecutive batches of
commercial scale.
xxx. 3.2.P.5 Submit clarification of using spectrophotometry for assay of Phenylephrine instead of
HPLC.
xxxi. 3.2.P.5 Submit Batch Analysis of two locally manufactured batches.
xxxii. 3.2.P.5 Submit detail of impurities that are degradation products.
xxxiii. 3.2.P.5 Submit justification of specifications of finished drug.
xxxiv. 3.2.P.6 Submit COAs of reference standards.
xxxv. 3.2.P.7 Submit complete description of container closure system along with capacity &
construct of ampoule.
xxxvi. 3.2.P.8 Submit scientific rational of batch size selected for stability studies.
xxxvii. Approval of APIs manufacturing facilities by regulatory authority of country of origin
xxxviii. Documents for the procurement of APIs with approval from DRAP.
xxxix. Compliance record of HPLC software 21CFR & audit trail reports on product testing.
xl. Record of Digital data logger for temperature and humidity monitoring of stability chambers
Item No. XIII: Agenda of Evaluator-XIII (Mr. Shahid Nawaz)

Case 01; Export Facilitation:
a. Registration applications of locally manufactured Human Drugs of Export Facilitation
on form 5F.
In pursuance of decision of 133rd meeting of DRAP Authority held on 13th April 2022, wherein it was decided
to grant registration on priority basis to the pharmaceutical i.e one molecule for each 100,000 USD worth of
export of medicines (to a maximum of 15 such molecules) during a fiscal year.
In compliance to the aforementioned decision of the Board, Assistant Director (PR-I/EFD) vide letter No.
F.1-6/2019-PR-I (EFD) dated 06th October, 2022 has informed that M/s Surge Laboratories (Pvt.) Ltd,
Sheikhupura has achieved the benchmark of more than 100,000 USD (790529.78 USD) during the fiscal
Year 2019-2020 and submitted their applications for priority consideration/ evaluation.
Following products are presented before the Board in light of the decision of the 133 rd meeting of DRAP
Authority held on 13th April 2022 for consideration.
425. Name, address of Applicant / Marketing M/s. Surge Laboratories (Pvt.) Ltd.,
Authorization Holder 10th Km, Faisalabad road, Bikhi, District Sheikhupura.
Name, address of Manufacturing site. M/s Nabi Qasim Industries Private Limited,
17 / 24, Korangi Industrial Area, Karachi.
Status of the applicant ☐Manufacturer
☐ Importer
☒Is involved in none of the above (contract giver)
☐ Export sale
Dy. No. and date of submission Dy. No. 4646 dated 18-02-2022.
Details of fee submitted PKR 30,000/- vide slip No.9509332184 dated
12/01/2022.
PKR 45,000/- vide slip No.65562075 dated
08/02/2022.
Prexa Tablets 5mg
name
Active Pharmaceutical ingredient (API) Escitalopram as Oxalate ……….. ……..5mg
per unit
Pharmaceutical form of applied drug A Light yellow colored, Square shape film coated
tablet, one side Plain while other side engraved by (+)
sign.
Pharmacotherapeutic Group of (API) Selective Serotonin Reuptake Inhibitor (SSRI), Anti-
Depressant (N06AB)
USP Specifications.
specifications
The status in reference regulatory Cipralex 5mg film coated Tablets, (Escitalopram as
authorities oxalate) MHRA approved.
For generic drugs (me-too status) Citanew Tablets 5mg by M/s Hilton Pharma (Pvt.)
Ltd., Reg. No. 037707
GMP status of the Finished product M/s Nabi Qasim Industries Private Limited,
manufacturer Copy of GMP certificate No.63/2022-DRAP (K) dated
28-05-2022 on the basis of inspection conducted on
27-05-2022 is submitted.
M/s. Surge Laboratories (Pvt.) Ltd.,
Not submitted.
Evidence of section approval. Tablet general section approved vide letter No. F.2-
20/85-Lic. (Vol-V) dated 27-04-2020.
Name and address of API manufacturer. M/s. Alcon Biosciences Private Limited,
Plot No. A-I/2014, phase III, G.I.D.C. Vapi -396 195,
Dist. – Valsad, Gujrat –India.
Copy of GMP certificate No. S-GMP/20102297 in the
name of M/s. Alcon Biosciences Private Limited,
issued by Food & Drug Control Administration
Gandhinagar, Gujrat, India valid till 21-10-2022 is
submitted.
structure, general properties, solubility, physical form,
and controls, tests for related substances (5-
Dimethylamino butyrylcitalopram, Citalopram
related compound A, Citalopram related compound B
(3- hydroxyl citalopram) , Citalopram related
compound C (3– oxocitalopram), Citalopram related
compound D (desmethyl citalopram), Citalopram
related compound E (citalopram N-Oxide) , Any other
Individual unspecified impurity, Total Impurities),
Batches: (ALC/ESO/180703, ALC/ESO/180704,
ALC/ESO/180705)
Module-III (Drug Product): The firm has submitted detail of the description and
composition of the drug product, manufacturers,
Process validation, specifications, analytical
product.
Pharmaceutical equivalence and Pharmaceutical Equivalence is established against the
comparative dissolution profile brand leader that is Citanew Tablet 5mg, Batch No.
138276, Mfg. date March, 2021 manufactured by
Hilton Pharma, by performing quality tests
(Description, Identification, Dissolution and Assay).
Results of both the products are comparable with each
other.
Comparative Dissolution Profile is also performed
against the same brand that is Citanew Tablet 5mg,
Batch No. 138276, Mfg. date March, 2021
manufactured by M/s Hilton Pharma (Pvt.) Ltd., in
acidic and Buffer mediums i.e. 0.1 N HCL medium pH
1.2, Acetate Buffer medium pH 4.5 & Phosphate
Buffer medium pH 6.8). Values of F2 are not
calculated as more than 85% release is observed in all
the three mediums in 15 minute time point.
validation/verification of product specificity, accuracy (recovery), precision, linearity&
range.
Manufacturer of API M/s. Alcon Biosciences Private Limited,
Plot No. A-I/2014, phase III, G.I.D.C. Vapi -396 195, Dist. – Valsad, Gujrat
–India.
API Lot No. ESO/FPR/007/20
Description of Pack
Alu-PVC blister packed in unit carton (1×14’s).
Batch No. MA0121. MA0221 MA0321
Batch Size 3000 tablets. 3000 tablets 3000 tablets
Manufacturing Date 05-2021. 05-2021 05-2021
Date of Initiation 14-05-2021. 14-05-2021 14-05-2021
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate Copy of GMP certificate No. S-GMP/20102297 in the
of API manufacturer issued by concerned name of M/s. Alcon Biosciences Private Limited,
regulatory authority of country of origin. issued by Food & Drug Control Administration
submitted.
3. Documents for the procurement of API Copy of commercial invoice No. AB/V00144/20-21
with approval from DRAP (in case of dated 28-01-2021 mentioning 1kg quantity of
import). Escitalopram Oxalate USP, batch No.
ESO/FPR/007/20, Mfg. date December, 2020 duly
attested by Assistant Director, DRAP, Karachi on 16-
02-2021 is submitted.
sheets etc.
testing
accelerated)
Sr. Section Observation Reply by the firm
No.
1. 1.3.4 Valid copy of GMP certificate/last Copy of GMP certificate No. 41/202-
inspection report of the applicant DRAP(Ad-9978029213) dated 05-04-
shall be submitted. 2022 issued on the basis of inspection
conducted on 05-10-2021 is submitted.
2. 1.6.5 Valid copy of GMP certificate of the Firm has once again submitted copy of
drug substance manufacturer shall GMP certificate No. S-GMP/20102297 in
be submitted. the name of M/s. Alcon Biosciences
Private Limited, issued by Food & Drug
Control Administration Gandhinagar,
Gujrat, India valid till 21-10-2022 is
submitted.
Not valid.
Firm has also submitted copy of Retention
of license issued by Commissioner Food
& Drugs Control Administration, Gujrat
State of India wherein M/s Alcon
Biosciences P Ltd., has been retained
from 01-01-2022 to 31-12-2026.
3. 3.2.P.2 Justification for not performing Firm has submitted that at the time of
CDP against the innovator product. development, the innovator product
Cipralex 5mg was not available, that’s
why CDP studies were performed with the
comparator product “Citanew tablets
5mg” as per the guidance document No.
PE&R/GL/AF/004 issued by DRAP.
4. 3.2.P.8 Stability study data of commercial Firm has submitted that in 321st meeting
batches shall be submitted. of Registration Board, it was decided that
the product development data/stability
data of trial batches manufactured by
contract manufacturer will also be
acceptable.
Decision: Approved.
426. Name, address of Applicant / M/s. Surge Laboratories (Pvt.) Ltd.,
Marketing Authorization Holder 10th Km, Faisalabad road, Bikhi, District Sheikhupura.
Name, address of Manufacturing site. M/s Nabi Qasim Industries Private Limited,
17 / 24, Korangi Industrial Area, Karachi.
Status of the applicant ☐Manufacturer
☐ Importer
☒Is involved in none of the above (contract giver)
☐ Export sale
Details of fee submitted PKR 30,000/- vide slip No.73252091018 dated
12/01/2022.
PKR 45,000/- vide slip No.9287160241 dated
08/02/2022.
Prexa Tablets 20mg
name
Active Pharmaceutical ingredient Escitalopram as Oxalate ……….. ……..20mg
(API) per unit
Pharmaceutical form of applied drug Purple colored, Square shape film coated tablet, one
side Plain while other side engraved by (+) sign.
Pharmacotherapeutic Group of (API) Selective Serotonin Reuptake Inhibitor (SSRI), Anti-
Depressant (N06AB)
USP Specifications.
specifications
Proposed unit price As per SRO.
The status in reference regulatory Cipralex 20mg film coated Tablets, (Escitalopram as
authorities oxalate) MHRA approved.
For generic drugs (me-too status) Citanew Tablets 20mg by M/s Hilton Pharma (Pvt.)
Ltd., Reg. No. 037681.
GMP status of the Finished product M/s Nabi Qasim Industries Private Limited,
manufacturer Copy of GMP certificate No. 124/2020-DRAP (K)
dated 06-10-2020 on the basis of inspection conducted
on 19-09-2020 is submitted.
M/s. Surge Laboratories (Pvt.) Ltd.,

Not submitted.
Evidence of section approval. Tablet general section approved vide letter No. F.2-
20/85-Lic. (Vol-V) dated 27-04-2020.
Name and address of API manufacturer. M/s. Alcon Biosciences Private Limited,
Plot No. A-I/2014, phase III, G.I.D.C. Vapi -396 195,
Dist. – Valsad, Gujrat –India.
Copy of GMP certificate No. S-GMP/20102297 in the
name of M/s. Alcon Biosciences Private Limited,
issued by Food & Drug Control Administration
submitted.
structure, general properties, solubility, physical form,
and controls, tests for related substances (5-
Dimethylamino butyryl citalopram, Citalopram
related compound A, Citalopram related compound B
(3- hydroxyl citalopram) , Citalopram related
compound C (3– oxocitalopram), Citalopram related
compound D (desmethyl citalopram), Citalopram
related compound E (citalopram N-Oxide) , Any other
Individual unspecified impurity, Total Impurities),
Batches: (ALC/ESO/180703, ALC/ESO/180704,
ALC/ESO/180705)
Module-III (Drug Product): The firm has submitted detail of the description and
composition of the drug product, manufacturers,
Process validation, specifications, analytical
product.
Pharmaceutical equivalence and Pharmaceutical Equivalence is established against the
comparative dissolution profile brand leader that is Cipralex Tablet 20mg, Batch No.
2689852, Mfg. date March, 2021 registered and being
marketed by H. Lundbeck Pakistan by performing
quality tests (Description, Identification, Dissolution
and Assay).
Results of both the products are comparable with each
other.
Comparative Dissolution Profile is also performed
against the same brand that is Cipralex Tablet 20mg,
Batch No. 2689852, Mfg. date March, 2021 registered
and being marketed by H. Lundbeck Pakistan., in
acidic and Buffer mediums i.e. 0.1 N HCL medium pH
1.2, Acetate Buffer medium pH 4.5 & Phosphate
Buffer medium pH 6.8). Values of F2 are not
calculated as more than 85% release is observed in all
the three mediums in 15 minute time point.
validation/verification of product specificity, accuracy (recovery), precision, linearity&
range.
Manufacturer of API M/s. Alcon Biosciences Private Limited,
Plot No. A-I/2014, phase III, G.I.D.C. Vapi -396 195, Dist. – Valsad, Gujrat
–India.
API Lot No. ESO/FPR/007/20
Description of Pack
Alu-PVC blister packed in unit carton (1×14’s).
Batch No. MA0421. MA0521 MA0621
Batch Size 3000 tablets. 3000 tablets 3000 tablets
Manufacturing Date 05-2021. 05-2021 05-2021
Date of Initiation 14-05-2021. 14-05-2021 14-05-2021
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate Copy of GMP certificate No. S-GMP/20102297 in the
of API manufacturer issued by name of M/s. Alcon Biosciences Private Limited,
concerned regulatory authority of issued by Food & Drug Control Administration
country of origin. Gandhinagar, Gujrat, India valid till 21-10-2022 is
submitted.
3. Documents for the procurement of API Copy of commercial invoice No. AB/V00144/20-21
with approval from DRAP (in case of dated 28-01-2021 mentioning 1kg quantity of
import). Escitalopram Oxalate USP, batch No.
ESO/FPR/007/20, Mfg. date December, 2020 duly
attested by Assistant Director, DRAP, Karachi on 16-
02-2021 is submitted.
sheets etc.
testing
accelerated)
No.
1. 1.3.4 Valid copy of GMP certificate/last Copy of GMP certificate No. 41/202-
inspection report of the applicant DRAP(Ad-9978029213) dated 05-04-
shall be submitted. 2022 issued on the basis of inspection
conducted on 05-10-2021 is submitted.
2. 1.6.5 Valid copy of GMP certificate of the Firm has once again submitted copy of
drug substance manufacturer shall GMP certificate No. S-GMP/20102297
be submitted. in the name of M/s. Alcon Biosciences
Private Limited, issued by Food & Drug
Control Administration Gandhinagar,
Gujrat, India valid till 21-10-2022 is
submitted.
Not valid.
Firm has also submitted copy of
Retention of license issued by
Commissioner Food & Drugs Control
Administration, Gujrat State of India
wherein M/s Alcon Biosciences P Ltd.,
has been retained from 01-01-2022 to 31-
12-2026.
3. 3.2.P.8 Stability study data of commercial Firm has submitted that in 321st meeting
batches shall be submitted. of Registration Board, it was decided that
the product development data/stability
data of trial batches manufactured by
contract manufacturer will also be
acceptable.
Decision: Approved.
In compliance to the aforementioned decision of the Board, Assistant Director (PR-I/EFD) vide letter No.
F.1-6/2019-PR-I (EFD) dated 06th October, 2022 has informed that M/s Surge Laboratories (Pvt.) Ltd,
Sheikhupura has achieved the benchmark of more than 100,000 USD (793,404.76) during the fiscal Year
2019-2020 and submitted their applications for priority consideration/ evaluation.
Following products are presented before the Board in light of the decision of the 133rd meeting of DRAP
427. Name, address of Applicant / Marketing M/s Tabros Pharma (Pvt.) Ltd., L-20/B, Sector-22, F.B.
Authorization Holder Industrial Area, Karachi.
Name, address of Manufacturing site. M/s Tabros Pharma (Pvt.) Ltd., L-20/B, Sector-22, F.B.
Industrial Area, Karachi.
☐ Importer
☐ Export sale
Details of fee submitted PKR 75,000/- dated 23-04-2022.
The proposed proprietary name / brand RAST-VT TABLET 10mg/80mg
name
Active Pharmaceutical ingredient (API) Rosuvastatin Calcium equivalent to Rosuvastatin
per unit ………………………………………. 10mg
Valsartan ……………………………... 80mg
Pharmaceutical form of applied drug Light red color, round, biconvex film coated tablets.
Pharmacotherapeutic Group of (API) Lipid modifying agents in combination with other
drugs (C10BX)
Reference to Finished product Tabros Specifications.
specifications
Proposed unit price As per DPC.
The status in reference regulatory Rosuvastatin/Valsartan HCS, Marketing
authorities Authorization Holder HCS bvba, Germany, (10 mg/80
mg, 20 mg/80 mg, 10 mg/160 mg, 20mg/160 mg)
Germany Approved.
Belgium approved.
VALAROX 10/80mg Tablet by KRKA. d.d.,
Novomesto, Bulgaria, Latvia
Ravalsyo in Slovenia & Hungry.
For generic drugs (me-too status) N/A.
Evidence of section approval. Tablet section vide letter No. F.2-5/87-Lic. (Vol-III)
30-06-2020.
Ruyuan HEC Pharm Co., Ltd.,
Xiaba Development Zone, Ruyuan County, Shaoguan
City, Guangdong Province, P.R. China.
The firm has submitted copy of GMP certificate No.
DE-BE-01-GMP-2019-0042 for M/s Ruyuan HEC
Pharm Co. Ltd., wherein the competent authority of
Germany has confirmed that the knowledge gained
during the inspection of the above said manufacturer,
the latest of which was conducted on 29-11-2019, it is
considered that it complies with the Good
Manufacturing Practice requirements referred to in “the
principles of GMP for active substances referred to in”
Article 47 of Directive 2001/83/EC.
The certificate is valid till 29th 11, 2022.
Valsartan:
Zhuhai Rundu Pharmaceutical Co., Ltd.,
No. 6, North Airport Road, Sanzao Town, Jinwan
District, Zhuhai City, Guangdong Province, 519041
P.R. China.
Copy of GMP certificate No. GD20190988 dated 11-
04-2019 in the name of M/s Zhuhai Rundu
Pharmaceutical Co., Ltd., valid till 10-04-2024 is
submitted.
Module-II (Quality Overall Summary) Firm has submitted QOS as per template provided in
293rd meeting of Registration Board.
Module III (Drug Substance) Firm has submitted detailed drug substance data for
rosuvastatin calcium related to general information,
physical description, manufacturer, Characterization,
impurities, Specifications, analytical procedures and its
Firm has also submitted detailed drug substance data
for Valsartan related to general information,
Stability studies (Drug Substance) Rosuvastatin Calcium;
Batches: (RSV-201803001, RSV-201803002 & RSV-
201803003).
Valsartan;
Batches: (64614080101, 64614080102 &
64614080103)
Module-III (Drug Product): Firm has summarized information of drug product
including its description, composition, pharmaceutical
process control, control of critical steps and
intermediate, process validation protocols , control of
comparative dissolution profile against the VALAROX 10/80mg Tablet manufactured
by KRKA. d.d., Novomesto, Bulgaria by performing
quality tests including Identification, water content,
Assay, Dissolution, Disintegration.
VALAROX 10/80mg Tablet manufactured by KRKA.
d.d., Novomesto, in Acid media (0.1N HCl), acetate
buffer pH 4.5 & Phosphate Buffer pH 6.8. The F2
values are found satisfactory.
Analytical method validation Method validation studies for finished product have
/verification of product submitted including following parameters: Linearity &
range, Accuracy, Precision, Specificity, Detection
limit, Quantitation limit, Robustness, Stability
indicating, Solution stability, Analytical method
validation for drug substance performed by drug
product manufacturer also submitted including
following parameters:
Linearity & Range, Accuracy, Precision & Specificity.
Xiaba Development Zone, Ruyuan County, Shaoguan City, Guangdong
Province, P.R. China.
Valsartan:
No. 6, North Airport Road, Sanzao Town, Jinwan District, Zhuhai City,
Guangdong Province, 519041 P.R. China.
API Lot No. Valsartan: 67820030607
Rosuvastatin Calcium: RSV-(RD)202010604(WI)
Description of Pack
Time Period Real time: 06months
Batch No. TR001-4/RVT TR002-4/RVT TR003-4/RVT
Manufacturing Date 09.2021 09-2021 09-2021
No. of Batches 03
1. Reference of previous approval of Firm has referred last onsite panel inspection for instant
applications with stability study data of the dosage form conducted during last two years BAXIB
firm (if any) (Apixaban) 2.5mg & 5mg Tablets on 5th January, 2021
by following panel:
1. Prof. Dr. Rafeeq Alam Khan, Dean, Faculty of
Pharmacy, Zia Uddin University, Karachi. (Member
Registration Board).
2. Dr. Saif-ur-Rehman Khattak, Director / FGA, CDL,
DRAP, Karachi.
• The HPLC software is 21 CFR complaint.
• Audit trials on the testing reports of Baxib
tablets were available.
2. Approval of API/ DML/GMP certificate Rosuvastatin Calcium:
of API manufacturer issued by concerned Ruyuan HEC Pharm Co., Ltd.,
regulatory authority of country of origin. Xiaba Development Zone, Ruyuan County, Shaoguan
Valsartan:
P.R. China.
submitted.
3. Documents for the procurement of API Rosuvastatin Calcium:
with approval from DRAP (in case of Firm has submitted copy of commercial invoice number
import). WIS200291 dated December, mentioning 50Kg
quantity of Rosuvastatin Calcium attested by Assistant
Director, I & E, DRAP Karachi dated 23-12-2020.
ADC signed Form 5 & Invoice are available while
Form 3 & Form 7 are also available.
Valsartan:
RD-2020041301-1 dated 16-04-2020 mentioning
650Kg quantity of Valsartan with Batch No.
67820030607, Mfg. date March, 2020 & retest date of
February, 2023 attested by Assistant Director I & E,
The utilization is restricted for sampling and for
submission & endorsement of certificate of analysis for
NDMA & EDMA impurities.
sheets etc.
testing
accelerated)
Sr. Section Observation Response by the firm
No. No.
1. 3.2.S.4.1 • Justification for specification for Firm has submitted that they have followed
water determination shall be USP specification for the testing of
submitted as the Finished Product Rosuvastatin calcium & in USP
manufacturer has provided NMT monograph limit of water content is NMT
6% while drug substance 6% while drug substance manufacturer has
manufacturer has NMT 3.5%. 3.5-4.5% which is in-house.
• Assay limit of valsartan is 98% in Assay limit of valsartan in USP is 98-102%
USP while FPP has mentioned and we have followed for the same &
98.5%. justify. submitted accordingly.
2. 3.2.S.4.2 Analytical procedures for the drug Submitted.
substance rosuvastatin calcium used
by the drug substance manufacturer
shall be submitted.
3. 3.2.S.4.4 Certificate of analysis for NDMA Firm has submitted the same commercial
and EDMA impurities in the drug invoice submitted above with following
substance i.e. valsartan after remarks of the Assistant Director, DRAP,
clearance from DRAP shall be Karachi;
submitted as the utilization was “COA regarding impurities was checked
restricted for sampling and for and utilization allowed.”
submission & endorsement of They further referred to a decision of
certificate of analysis for NDMA & Registration Board in its 312th meeting,
EDMA impurities. wherein in point “a” it is decided by the
Board that;
a. The manufacturers of Valsartan API
which have valid certificate of suitability
as per EDQM or any other Reference
Regulatory Authorities (RRAs), as adopted
by the Registration Board, are exempted
from NDMA/NDEA testing on every
consignment.
b. Import of Valsartan API by DML
holders from manufacturers not covered in
point a shall be subject to testing as per
decision of 291st meeting of Registration
Board.
However, neither any certificates for
NDMA and EDMA impurities in the drug
substance is provided by the firm nor any
valid certificate of suitability as per
EDQM or any other Reference Regulatory
Authorities (RRAs), as adopted by the
Registration Board.
4. 3.2.P.2.2 Justification for not performing Firm has stated that Pharmaceutical
CDP & PE against the Reference equivalence and CDP studies against the
Regulatory Authority country reference product of “Valarox Tablets” in
product. three dissolution medium has been
submitted with a acceptance level of F2
results.
Although the product is available in
Germany with the brand name of
Rosuvastatin/valsartan HCS film coated
tablets which is sufficient reference for
RRA country. Furthermore, based on
reference regulatory authorities by the
DRAP in 275th DRB meeting, in which it
has clearly mentioned that at least three EU
countries product should be available as
reference for consideration of registration
board of the product. Reference products
are also available more than three EU
countries which are as follows:
• Bulgaria & Latvia with the brand name
of Valarox.
• Slovenia & Hungry with the brand name
of Ravalsyo.
5. 3.2.P.5.2 Provide scientific rationale for The scientific rational for selection of
selection of dissolution parameters dissolution medium and type of apparatus
including type of apparatus, rpm, carried out, based on FPP of Valsartan
dissolution medium, sampling time Tablets in the USP monograph, however,
and the analytical method. rpm and sample elapsed time set the
parameters grounded on practical
observation and In-House analytical
method was developed, Dissolution
method validation is being submitted as
per ICH guidelines.
6. 3.2.P.3.3 • Manufacturing process has Firm has submitted that they have followed
mentioned bilayer tablets same manufacturing procedure as similar
however, label claim has not as reference product. It is bilayer tablet &
mentioned. Justification shall be finally covered with film coating.
submitted. Supportive/ Orientation document is
attached for your ready reference where it
is evidently mentioned film coated tablets,
Hence, we are claiming film coated tablets.
Firm has submitted that they are
• Evidence of availability of bilayer manufacturing the “Cresar-AM” bi-layer
tablet machine shall be submitted. tablets on commercial scale and marketed
accordingly since long time.
They further submitted routine GMP
inspection report of October, 2018 wherein
it is mentioned in the report that the firm
has recently purchased Rotary tablet press
Machine ZP-31 (for double layer tablet
manufacturing).
7. The chromatograms provided for Firm has submitted that the assay of SIM
dissolution studies have run time of method and Dissolution method are
6 minutes and column temperature developed separately having different
is mentioned 40ºC. The method chromatographic conditions, hence, both
validated for assay has a run time of chromatographic conditions are seeming to
65 minutes and column temperature be different.
is less than 40ºC. It appears as if the They further submitted dissolution method
HPLC method used in dissolution is validation report which was not submitted
not validated. in the initial submission.
Justify/provide validation studies
for HPLC method used in
dissolution
• Registration letter will be issued after submission of fee of Rs. 7,500/- for correction/pre-
approval change in the method of manufacture/specifications, as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021.
☐ Importer
☐ Export sale
RAST-VT TABLET 20mg/80mg
name
per unit ………………………………………. 20mg
Valsartan ……………………………... 80mg
Pharmaceutical form of applied drug Light brown color, oblong, biconvex film coated
tablets.
drugs (C10BX)
Tabros Specifications.
specifications
The status in reference regulatory Rosuvastatin/Valsartan HCS, Marketing Authorization
authorities Holder HCS bvba, Germany, (10 mg/80 mg, 20 mg/80
mg, 10 mg/160 mg, 20mg/160 mg) Germany
Approved.
30-06-2020.
Valsartan:
P.R. China.
submitted.
Stability studies (Drug Substance) Rosuvastatin Calcium
201803003).
Valsartan
Batches: (64614080101, 64614080102 &
64614080103)
comparative dissolution profile against the VALAROX 20/80mg Tablet Batch No.
NJ2137 by KRKA. d.d., Novomesto, Bulgaria by
performing quality tests including Identification, water
content, Assay, Dissolution, Disintegration.
VALAROX 20/80mg Tablet Batch No. NJ2137 by
KRKA. d.d., Novomesto, in Acid media (0.1N HCl),
acetate buffer pH 4.5 & Phosphate Buffer pH 6.8. The
Valsartan:
Description of Pack
No. of Batches 03
by following panel:
DRAP, Karachi.
Valsartan:
P.R. China.
submitted.
Valsartan:
sheets etc.
testing
accelerated)
No. No.
1. 3.2.S.4.1 • Justification for specification for Firm has submitted that they have
water determination shall be followed USP specification for the
submitted as the Finished Product testing of Rosuvastatin calcium & in
manufacturer has provided NMT USP monograph limit of water content is
6% while drug substance NMT 6% while drug substance
manufacturer has NMT 3.5%. manufacturer has 3.5-4.5% which is in-
• Assay limit of valsartan is 98% in house.
USP while FPP has mentioned
98.5%. justify.
Assay limit of valsartan in USP is 98-
102% and we have followed for the same
& submitted accordingly.
shall be submitted.
3. 3.2.S.4.4 Certificate of analysis for NDMA and Firm has submitted the same commercial
EDMA impurities in the drug invoice submitted above with following
substance i.e. valsartan after clearance remarks of the Assistant Director,
from DRAP shall be submitted as the DRAP, Karachi;
utilization was restricted for sampling “COA regarding impurities was checked
and for submission & endorsement of and utilization allowed.”
certificate of analysis for NDMA & They further referred to a decision of
EDMA impurities. Registration Board in its 312th meeting,
wherein in point “a” it is decided by the
Board that;
Regulatory Authorities (RRAs), as
adopted by the Registration Board, are
exempted from NDMA/NDEA testing on
every consignment.
holders from manufacturers not covered
in point a shall be subject to testing as
per decision of 291st meeting of
Registration Board.
EDQM or any other Reference
adopted by the Registration Board.
4. 3.2.P.2.2 Justification for not performing CDP Firm has stated that Pharmaceutical
& PE against the Reference equivalence and CDP studies against the
Regulatory Authority country reference product of “Valarox Tablets”
product. in three dissolution medium has been
results.
has clearly mentioned that at least three
EU countries product should be available
as reference for consideration of
registration board of the product.
Reference products are also available
more than three EU countries which are
as follows:
• Bulgaria & Latvia with the brand
name of Valarox.
Slovenia & Hungry with the brand name
of Ravalsyo.
selection of dissolution parameters dissolution medium and type of
including type of apparatus, rpm, apparatus carried out, based on FPP of
dissolution medium, sampling time Valsartan Tablets in the USP
and the analytical method. monograph, however, rpm and sample
elapsed time set the parameters grounded
on practical observation and In-House
analytical method was developed,
Dissolution method validation is being
submitted as per ICH guidelines.
6. 3.2.P.3.3 • Manufacturing process has Firm has submitted that they have
mentioned bilayer tablets however, followed same manufacturing procedure
label claim has not mentioned. as similar as reference product. It is
Justification shall be submitted. bilayer tablet & finally covered with film
coating. Supportive/ Orientation
document is attached for your ready
• Evidence of availability of bilayer reference where it is evidently mentioned
tablet machine shall be submitted. film coated tablets, Hence, we are
claiming film coated tablets.
manufacturing the “Cresar-AM” bi-
layer tablets on commercial scale and
marketed accordingly since long time.
inspection report of October, 2018
wherein it is mentioned in the report that
the firm has recently purchased Rotary
tablet press Machine ZP-31 (for double
layer tablet manufacturing).
7. 3.2.P.2.2 • The chromatograms provided for Firm has submitted that the assay of SIM
validated for assay has a run time of chromatographic conditions are seeming
65 minutes and column temperature to be different.
is less than 40ºC. It appears as if the They further submitted dissolution
HPLC method used in dissolution is method validation report which was not
not validated. submitted in the initial submission.
• Justify/provide validation studies
dissolution for the applied
formulation.
11/2012-B&A/DRAP dated 13-07-2021.
☐ Importer
☐ Export sale
name
per unit ………………………………………. 10mg
Valsartan ……………………………... 160mg
Pharmaceutical form of applied drug Brown to dark brown color, oblong, biconvex film
coated tablets.
drugs (C10BX)
specifications
mg, 20 mg/80 mg, 10 mg/160 mg, 20mg/160 mg)
Germany Approved.
Belgium approved.
30-06-2020.
Valsartan:
P.R. China.
submitted.
201803003).
Valsartan;
Batches: (64614080101, 64614080102 &
64614080103)
comparative dissolution profile against the VALAROX 10/160mg Tablet, batch No.
NJ8299 manufactured by KRKA. d.d., Novomesto,
Bulgaria by performing quality tests including
Disintegration.
VALAROX 10/160mg Tablet manufactured by
Valsartan:
Description of Pack
No. of Batches 03
firm (if any)
(Apixaban) 2.5mg & 5mg Tablets on 5th January, 2021
by following panel:
DRAP, Karachi.
Valsartan:
P.R. China.
submitted.
Valsartan:
sheets etc.
testing
accelerated)
No. No.
1. 3.2.S.4.1 • Justification for specification for Firm has submitted that they have
water determination shall be followed USP specification for the testing
submitted as the Finished Product of Rosuvastatin calcium & in USP
manufacturer has provided NMT monograph limit of water content is NMT
6% while drug substance 6% while drug substance manufacturer
manufacturer has NMT 3.5%. has 3.5-4.5% which is in-house.
Assay limit of valsartan in USP is 98-
• Assay limit of valsartan is 98% in 102% and we have followed for the same
USP while FPP has mentioned & submitted accordingly.
98.5%. justify.
shall be submitted.
Board that;
adopted by the Registration Board, are
exempted from NDMA/NDEA testing on
every consignment.
holders from manufacturers not covered
in point a shall be subject to testing as per
decision of 291st meeting of Registration
Board.
EDQM or any other Reference
adopted by the Registration Board.
4. 3.2.P.2.2 Justification for not performing CDP Firm has stated that Pharmaceutical
& PE against the Reference equivalence and CDP studies against the
results.
has clearly mentioned that at least three
EU countries product should be available
as reference for consideration of
registration board of the product.
Reference products are also available
more than three EU countries which are as
follows:
of Valarox.
Slovenia & Hungry with the brand name
of Ravalsyo.
method was developed, Dissolution
method validation is being submitted as
per ICH guidelines.
6. 3.2.P.3.3 • Manufacturing process has Firm has submitted that they have
mentioned bilayer tablets however, followed same manufacturing procedure
label claim has not mentioned. as similar as reference product. It is
Justification shall be submitted. bilayer tablet & finally covered with film
coating. Supportive/ Orientation
document is attached for your ready
reference where it is evidently mentioned
film coated tablets, Hence, we are
claiming film coated tablets.
• Evidence of availability of bilayer Firm has submitted that they are
tablet machine shall be submitted. manufacturing the “Cresar-AM” bi-layer
tablets on commercial scale and marketed
accordingly since long time.
inspection report of October, 2018
wherein it is mentioned in the report that
the firm has recently purchased Rotary
tablet press Machine ZP-31 (for double
layer tablet manufacturing).
validated for assay has a run time of chromatographic conditions are seeming
65 minutes and column to be different.
temperature is less than 40ºC. It They further submitted dissolution
appears as if the HPLC method method validation report which was not
used in dissolution is not validated. submitted in the initial submission.
• Justify/provide validation studies
formulation.
11/2012-B&A/DRAP dated 13-07-2021.
☐ Importer
☐ Export sale
name
per unit ………………………………………. 20mg
Valsartan ……………………………... 160mg
Pharmaceutical form of applied drug Light yellow color, oblong, biconvex film coated
tablets.
drugs (C10BX)
specifications
mg, 20 mg/80 mg, 10 mg/160 mg, 20mg/160 mg)
Germany Approved.
Belgium approved.
30-06-2020.
Valsartan:
P.R. China.
submitted.
201803003).
Valsartan;
Batches: (64614080101, 64614080102 &
64614080103)
comparative dissolution profile against the VALAROX 20/160mg, batch No. NJ58338
Tablet manufactured by KRKA. d.d., Novomesto,
Bulgaria by performing quality tests including
Disintegration.
VALAROX 20/160mg Tablet manufactured by
Valsartan:
Description of Pack
No. of Batches 03
by following panel:
DRAP, Karachi.
Valsartan:
P.R. China.
submitted.

Valsartan:
sheets etc.
testing
accelerated)
No. No.
1. 3.2.S.4.1 • Justification for specification for Firm has submitted that they have followed
water determination shall be USP specification for the testing of
submitted as the Finished Rosuvastatin calcium & in USP monograph
Product manufacturer has limit of water content is NMT 6% while
provided NMT 6% while drug drug substance manufacturer has 3.5-4.5%
substance manufacturer has which is in-house.
NMT 3.5%. Assay limit of valsartan in USP is 98-102%
• Assay limit of valsartan is 98% and we have followed for the same &
in USP while FPP has submitted accordingly.
mentioned 98.5%. justify.
substance rosuvastatin calcium
used by the drug substance
manufacturer shall be submitted.
Board that;
which have valid certificate of suitability as
per EDQM or any other Reference
Regulatory Authorities (RRAs), as adopted
by the Registration Board, are exempted
from NDMA/NDEA testing on every
consignment.
b. Import of Valsartan API by DML holders
from manufacturers not covered in point a
shall be subject to testing as per decision of
291st meeting of Registration Board.
valid certificate of suitability as per EDQM
or any other Reference Regulatory
Authorities (RRAs), as adopted by the
Registration Board.
4. 3.2.P.2.2 Justification for not performing Firm has stated that Pharmaceutical
CDP & PE against the Reference equivalence and CDP studies against the
results.
has clearly mentioned that at least three EU
countries product should be available as
reference for consideration of registration
board of the product. Reference products
are also available more than three EU
countries which are as follows:
of Valarox.
Slovenia & Hungry with the brand name of
Ravalsyo.
method was developed, Dissolution method
validation is being submitted as per ICH
guidelines.
6. 3.2.P.3.3 • Manufacturing process has Firm has submitted that they have followed
mentioned bilayer tablets same manufacturing procedure as similar as
however, label claim has not reference product. It is bilayer tablet &
mentioned. Justification shall be finally covered with film coating.
submitted. Supportive/ Orientation document is
attached for your ready reference where it is
evidently mentioned film coated tablets,
Hence, we are claiming film coated tablets.
• Evidence of availability of manufacturing the “Cresar-AM” bi-layer
bilayer tablet machine shall be tablets on commercial scale and marketed
submitted. accordingly since long time.
inspection report of October, 2018 wherein
it is mentioned in the report that the firm has
recently purchased Rotary tablet press
Machine ZP-31 (for double layer tablet
manufacturing).
dissolution studies have run time method and Dissolution method are
of 6 minutes and column developed separately having different
temperature is mentioned 40ºC. chromatographic conditions, hence, both
The method validated for assay chromatographic conditions are seeming to
has a run time of 65 minutes and be different.
column temperature is less than They further submitted dissolution method
40ºC. It appears as if the HPLC validation report which was not submitted
method used in dissolution is not in the initial submission.
validated.
Justify/provide validation studies
formulation.
11/2012-B&A/DRAP dated 13-07-2021.
In compliance to the aforementioned decision of the Authority, Assistant Director (PR-I/EFD) vide letter No.
F.1-6/2019-PR-I (EFD) dated 06th October, 2022 has informed that M/s Atco Laboratories Ltd, Karachi
has achieved the benchmark of more than 100,000 USD (542,854.81 USD) during the fiscal Year 2019-2020
and submitted their applications for priority consideration/ evaluation.
431. Name, address of Applicant / Marketing M/s Atco Laboratories Limited., B-18, S.I.T.E.
Authorization Holder Karachi.
Name, address of Manufacturing site. M/s Atco Laboratories Limited., B-18, S.I.T.E.
Karachi.
Status of the applicant ☒ Manufacturer.
☐ Importer.
☐ Is involved in none of the above (contract giver).
Status of application ☐ New Drug Product (NDP).
☒ Generic Drug Product (GDP).
Intended use of pharmaceutical product ☐ Domestic sale.
☐ Export sale.
☒ Domestic and Export sales.
Dy. No. and date of submission Dy. No 3726 dated 09-02-2022.
Details of fee submitted Rs.30,000/- dated 21-12-2021.
The proposed proprietary name / brand name Lenalidomide 5mg Capsule.
Pharmaceutical ingredient (API) per unit Lenalidomide ………………….…5mg
Pharmaceutical form of applied drug Oral Capsule.
Pharmacotherapeutic Group of (API) L04 Immunosuppressant’s.
Reference to Finished product specifications Innovator’s specifications.
Proposed Pack size 7’s, 10’s, 14’s, 20’s, 21’s, 28’s, 30’s, 60’s, & 100’s.
Proposed unit price As per policy.
The status in reference regulatory authorities Revlimid 5mg Capsules USFDA approved.
For generic drugs (me-too status) Not submitted.
manufacturer
Evidence of section approval. Capsule general section approved vide letter No. F.
No.F.2-5/85-Lic (Vol-VI) dated 23-01-2019.
Name and address of API manufacturer. M/s Changhzhou Pharmaceutical Factory, No. 518,
Laodong East Road, Changhzhou, Jiangsu 213018,
China.
Module-II (Quality Overall Summary) Firm has submitted QOS details as per WHO QOS
PD template.
Module III (Drug Substance) Firm has submitted detail of the drug substance
regarding nomenclature, structure, general
process and controls, tests for impurities & related
substances, specifications, analytical procedures
closure system and stability studies of both drug
substances.
Stability studies (Drug substance.) Stability study conditions:
Batches: (ELNB210401, ELNB210501 &
ELNB210701)
months
Batches: (LNB-161002, LNB-161003 & LNB-
161004)
Module-III (Drug Product): The firm has submitted detail of the drug product
including its composition, formulation
development, pharmaceutical equivalence,
comparative dissolution profile, manufacturer,
Pharmaceutical equivalence and Not submitted.
Analytical method validation/verification of Method Validation studies have submitted including
product linearity, range, accuracy, precision, specificity.
Manufacturer of API M/s Changhzhou Pharmaceutical Factory, No. 518, Laodong East
Road, Changhzhou, Jiangsu 213018, China.
API Lot No. ZSELNB210201.
Description of Pack
7’s Capsule in Alu-Alu blisters, packed in a printed carton.
Batch No. AP166C AP167C AP168C
Batch Size 6000 capsules 6000 capsules 6000 capsules
No. of Batches 03
applications with stability study data of the product “Rofl 500mcg Tablets” which was
firm (if any) conducted on 10-10-2017, and was presented in
277th meeting of Registration Board (27 - 29
December, 2017).
Following observations were reported in the report:
✓ The HPLC software is 21CFR Compliant.
✓ Audit trail reports on the testing were verifiable.
Firm has adequate monitoring and controls for
stability chambers.
2. Approval of API/ DML/GMP certificate of Firm has submitted copy of GMP certificate issued
API manufacturer issued by concerned in the name of M/s Changhzhou Pharmaceutical
regulatory authority of country of origin. Factory, No. 518, Laodong East Road, Changhzhou,
Jiangsu 213018, China issued by Jiangsu
Changzhou Drug Administration. The certificate
remains valid till 27-08-2022.
Firm has also submitted copy of license for drug
production No. Su20160138 for M/s Changhzhou
Pharmaceutical Factory, No. 518, Laodong East
Road, Changhzhou, Jiangsu 213018, China valid till
24-09-2025.
3. Documents for the procurement of API with Firm has submitted copy of form 6 No. 1088 dated
approval from DRAP (in case of import). 01/04/2021 issued in the name M/s Atco
Laboratories Limited., B-18, S.I.T.E. Karachi
mentioning 0.965kg quantity of Lenalidomide
attested by Assistant Director, DRAP, Karachi. Firm
has also submitted copy of commercial invoice No.
CYI20457 dated 11-03-2021 mentioning 0.965kg
quantity of Lenalidomide, Batch No.
ZSELNB210201 attested by Assistant Director,
DRAP, Karachi dated 01/04/2021.
testing
No.
1. 1.3.4 • Valid copy of DML of the Firm has replied that they submitted
applicant shall be submitted as application for renewal of Drug
the provide one is w.e.f. 11-04- Manufacturing License before the expiry
2016. of license i.e., on 17th March, 2021.
Therefore, as per the conditions of Rule 6
of Drugs Licensing, Registering and
Advertising Rules, 1976 our DML is still
valid.
• Latest GMP certificate/last Copy of GMP certificate No. 160/2020-
inspection report conducted DRAP (K) dated 24-12-2020 on the basis
within last three years of the of inspection conducted on 06-11-2020 is
finished product manufacturer submitted by the firm
shall be submitted.
2. 1.6.5 Valid copy of GMP certificate of Firm has submitted a document with
the drug substance manufacturer heading of “written confirmation for
issued by concerned/relevant active substances exported to EU” issued
regulatory authority shall be by Jiangsu Drug Administration wherein
submitted. the issuing authority confirms that the
manufacturing plant complies with the
requirements of Chinese Good
Manufacturing Practices (GMP of EU,
WHO/ICT Q7) and this written
confirmation remains valid till 23-08-
2024.
Copy of GMP certificate

(No.JS20180928) of Changzhou
Pharmaceutical Factory issued by China
Food and Drug Administration. The
certificate is valid till 12-11-2023. The
certificate is also verified online from
NMPA database.
3. 1.5.8 Evidence of approval of applied Firm has submitted differential fee of
formulation already approved by 45000/- vide slip No. 7965161967 dated
DRAP with brand name, 17-10-2022.
Registration number and
manufacturer name shall be
submitted.
4. 3.2.S.4.3 Validation studies of the drug Firm has submitted method verification
substance performed by the drug studies for the drug substance including
product manufacturer shall be Specificity, Accuracy, Precision and
submitted. Range.
5. 3.2.S.7.3 Complete real time stability studies Real time stability data of three batches i.e.
for the drug substance shall be ELNB210401, ELNB210501 &
submitted. ELNB210701 only for 12 months is
provided.
While the accelerated stability data of
three batches i.e. ELNB210401,
ELNB210501 & ELNB210701 for 06
months is provided.
Real time Stability study data is only for
one year.
6. 3.2.P.2.2 • Composition of finished product Firm has submitted that in Module 3,
has mentioned 147mg of section 3.2.P.2.2, in submitted product
Lenalidomide per capsule. development document, page number 16
Justification shall be submitted. clearly indicates the quantity of API in
finished product as 5mg but, on page
number 10 we have mentioned the
quantities of excipients only in which
147mg quantity is mentioned against
Lactose Anhydrous to be used in the
manufacturing of Lenalidomide capsule
5mg.
• Comparison of the developed However, the said page has mentioned
formulation and the innovator / Lenalidomide 147mg.
reference / comparator product Firm has submitted that they have already
including the results of all the submitted Pharmaceutical Equivalence
quality tests shall be submitted through Comparative Dissolution Profile
and discussed (Pharmaceutical for our product Lenalidomide Capsule
Equivalence studies. 5mg in which drug release is greater than
• The results of comparative 85% within 15minutes and no need to
dissolution profile conducted in calculate f2 factor as the Innovator product
three BCS media across the for Lenalidomide Capsule 5mg is not
physiological pH range along available locally or internationally.
with calculation of similarity Further, Pharmaceutical Equivalence and
factor f2 shall be submitted and Comparative Dissolution Profile against
discussed (Comparative innovator product for Lenalidomide
dissolution profile.) Capsule 10mg and Lenalidomide Capsule
25mg have also been submitted which
indicates the equivalency of Lenalidomide
Capsule 5mg as the formulation of
Lenalidomide Capsule 5mg is based on
dose proportion with other strengths of
Lenalidomide Capsule. Pharmaceutical
Equivalence report for Lenalidomide
Capsule 5mg containing our product
results is being submitted for your ready
reference.
Firm has neither submitted any
Comparative dissolution studies against
the innovator/comparator/reference
product.
They just provided release studies of the
applied formulation in different medias.
7. 3.2.P.5.2 Sample preparation method in the Submitted.
dissolution studies shall be
submitted.
8. 3.2.P.8 • Stability condition for real time Firm has submitted that they conduct
stability studies of the drug stability studies on more worst condition
product are 30°C ± 2°C / 75% ± than those data is also acceptable for
5%RH instead of 30°C ± 2°C / comparatively relaxed condition. As per
65% ± 5%RH. Justification shall policy we conduct the stability studies for
be submitted. real time as per Zone IV(b) requirement
which is more stringent and acceptable for
DRAP requirement for Zone IV(a) as well
as for those regulatory authorities where
requirement is IV(b).
Decision: Deferred for the following;
• Pharmaceutical Equivalence studies of the developed formulation and the innovator / reference
/ comparator product including the results of all the quality tests shall be submitted.
• The results of comparative dissolution profile conducted in three BCS media across the
physiological pH range along with calculation of similarity factor f2 against the innovator
Karachi.
☐ Importer.
Intended use of pharmaceutical product ☒ Domestic sale.
☐ Export sale.
☐Domestic and Export sales.
Pharmaceutical ingredient (API) per unit Lenalidomide ……………………….…10mg
For generic drugs (me-too status) Lenalidomide 10mg Capsule, Lab diagnostic
system, Reg. No. 110507.
manufacturer
China.
PD template.
system and stability studies of both drug substances.
ELNB210701)
months
161004)
Pharmaceutical equivalence and Pharmaceutical Equivalence is established against
comparative dissolution profile the reference product Lenalidomide 10mg capsules
batch number 2730017 manufactured by Beacon
Pharmaceuticals Limited by performing quality
tests (Identification, Description, Disintegration
time, Dissolution & Assay).
CDP has been performed against the Linamide
10mg capsules batch number 2730017 Mfg. date
01-2021, Exp. Date 12-2022 in in three different
mediums i.e. pH 1.2 in 0.1 N HCl, pH 4.5 Acetate
buffer & pH 6.8 Phosphate buffer. In all the three
mediums, both the reference product and test
product have shown more than 85% release in 15
minutes, therefore, F2 is not calculated.
product specificity, linearity, range, accuracy, precision,
robustness.
Manufacturer of API M/s Changhzhou Pharmaceutical Factory, No. 518, Laodong East
Road, Changhzhou, Jiangsu 213018, China.
API Lot No. ZSELNB210201.
Description of Pack
Batch No. AP155C AP156C AP157C
Batch Size 3000 capsules 3000 capsules 3000 capsules
No. of Batches 03
December, 2017).
✓ Firm has adequate monitoring and controls for
stability chambers.
24-09-2025.
testing
No.
the provide one is w.e.f. 11-04- Manufacturing License before the expiry of
2016. license i.e., on 17th March, 2021. Therefore,
as per the conditions of Rule 6 of Drugs
Licensing, Registering and Advertising
Rules, 1976 our DML is still valid.
• Latest GMP certificate/last Copy of GMP certificate No. 160/2020-
inspection report conducted DRAP (K) dated 24-12-2020 on the basis
within last three years of the of inspection conducted on 06-11-2020 is
finished product manufacturer submitted by the firm
shall be submitted.
the drug substance manufacturer heading of “written confirmation for active
issued by concerned/relevant substances exported to EU” issued by
regulatory authority shall be Jiangsu Drug Administration wherein the
submitted. issuing authority confirms that the
confirmation remains valid till 23-08-2024.
Copy of GMP certificate (No.JS20180928)

of Changzhou Pharmaceutical Factory
Administration. The
NMPA China database.
submitted. Range.
provided.
While the accelerated stability data of three
batches i.e. ELNB210401, ELNB210501 &
ELNB210701 for 06 months is provided.
one year.
5. 3.2.P.2.2 In both Pharmaceutical Firm has submitted that in product
Equivalence and Comparative development data we have mentioned
Dissolution Profile two different details of brand leader as reference product
brand names are mentioned while which is REVLIMID CAPSULE
formulation development has manufactured by Celgene Corporation
mentioned product of Celgene Summit, NJ 07901, but, due to
pharma. In some places Beacon unavailability of this reference product in
Pakistan, we have performed
pharma products are mentioned. pharmaceutical equivalence and
Clarification shall be submitted. Comparative Dissolution Profile studies
against locally available brand i.e.,
Linamide Capsule manufactured by
Beacon Pharmaceuticals Limited
Bangladesh. This is in accordance with the
decision of Drug Registration Board taken
in its 307th meeting.
6. 3.2.P.2.2.1 Justification shall be submitted As per WHO, Annex 6, Multisource
regarding the selection of only two (generic) pharmaceutical products:
time points and paddle speed of 75 guidelines on registration requirements to
rpm in comparative dissolution establish interchangeability, 10.1.2
studies. Reference product has Determination of dissolution
used 50rpm and sampling time of characteristics of multisource products in
10, 15, 20, 30 & 45. consideration of a bio waiver based on the
Biopharmaceutics Classification System,
for very rapid release product use paddle
apparatus at 75 rpm therefore subjected
speed conducted for CDP. Also Minutes of
293rd Meeting of Registration Board (6 –
8th January, 2020), USFDA Guidance for
Industry Dissolution Testing of Immediate
Release Solid Oral Dosage Forms was
followed for guidance which states “with
the paddle method, it is 50-75 rpm (Shah et
al., 1992).” (Section 3.2.P.2.2.1). While
reference product manufacturer used 50
rpm for finish product dissolution testing
and we also performed the same for
submitted initial & stability studies.
Further regarding the selection of only two
time points, same above references are
adopted as the test product releases above
85% in 10 minutes then only further one-
time point included in report and
dissolution release achieved 85% for both
of test and reference products within 15
minutes due to this no need to calculate f2
factor therefore 3rd time point is not the part
of test report. Reference of above
guidelines attached in the section of
(3.2.P.2.2.1).
submitted.
8. 3.2.P.8 • Date of manufacturing of all the Firm has submitted that as per their policy,
three trial batches 04-2021 while they allocate the manufacturing date by
the analysis date is 20-06-2021. date of dispensing of raw material and for
Justification for this delay shall this product the date of
be submitted. dispensing/manufacturing is 28/04/2021.
You may realize that this is oral solid
dosage form which requires more process
time as compare to other dosage forms.
Mostly an oral solid dosage form batch
requires Twenty (20) days to one (1) month
to complete the manufacturing process then
QC testing and then subjected the finish
form for stability studies so, in normal
course of action forty-five (45) to sixty (60)
days is required to put the batches in
• Stability condition for real time stability chamber since dispensing of the
stability studies of the drug material (28/04/2021).
product are 30°C ± 2°C / 75% ± Firm has submitted that they conduct
5%RH instead of 30°C ± 2°C / stability studies on more worst condition
65% ± 5%RH. Justification shall than those data is also acceptable for
be submitted. comparatively relaxed condition. As per
policy we conduct the stability studies for
real time as per Zone IV(b) requirement
9. Firm has also submitted differential fee of
45000/- vide slip No. 4580801013 dated
17-10-2022.
Decision: Approved.
Karachi.
☐ Importer.
Intended use of pharmaceutical product ☒ Domestic sale.
☐ Export sale.
☐Domestic and Export sales.
Pharmaceutical ingredient (API) per unit Lenalidomide ……………………….…25mg
For generic drugs (me-too status) Firm has submitted copy of minutes of minutes of
283rd meeting of Registration Board wherein the
product of M/s Helix Pharma, Relidomide 25mg
imported from India, is approved by the Board as
per policy of inspections of manufacturer abroad.
Lenoma 25mg Capsule, Gene Tech laboratories,
Reg. No. 110502.
manufacturer
China.
PD template.
system and stability studies of both drug substances.
ELNB210701)
months
161004)
Pharmaceutical equivalence and Pharmaceutical Equivalence is established against
comparative dissolution profile the reference product Lenalidomide 25mg capsules
batch number 2740007 manufactured by Beacon
Pharmaceuticals Limited by performing quality
tests (Identification, Description, Disintegration
time, Dissolution & Assay).
CDP has been performed against the Linamide
25mg capsules batch number 2730017 Mfg. date
12-2020, Exp. Date 11-2022 in in three different
mediums i.e. pH 1.2 in 0.1 N HCl, pH 4.5 Acetate
buffer & pH 6.8 Phosphate buffer. In all the three
mediums, both the reference product and test
product have shown more than 85% release in 15
minutes, therefore, F2 is not calculated.
product specificity, linearity, range, accuracy, precision,
robustness.
Manufacturer of API Nantong Chanyoo Pharmatech Co. Ltd.,
No. 2 Tonghai Si Road, Rudong Coastal Economic Development
Zone, Nantong, Jiangsu Province China.
API Lot No. RD-TG-201907211.
Description of Pack
Batch Size 3000 capsules. 3000 capsules. 3000 capsules.
No. of Batches 03
December, 2017).
✓ Firm has adequate monitoring and controls for
stability chambers.
24-09-2025.
testing
No.
the provide one is w.e.f. 11-04- Manufacturing License before the expiry of
2016. license i.e., on 17th March, 2021. Therefore,
as per the conditions of Rule 6 of Drugs
Licensing, Registering and Advertising
Rules, 1976 our DML is still valid.
Copy of GMP certificate No. 160/2020-
• Latest GMP certificate/last DRAP (K) dated 24-12-2020 on the basis
inspection report conducted of inspection conducted on 06-11-2020 is
within last three years of the submitted by the firm
finished product manufacturer
shall be submitted.
the drug substance manufacturer heading of “written confirmation for active
issued by concerned/relevant substances exported to EU” issued by
regulatory authority shall be Jiangsu Drug Administration wherein the
submitted. issuing authority confirms that the
confirmation remains valid till 23-08-2024.
Copy of GMP certificate (No.JS20180928)

of Changzhou Pharmaceutical Factory
Administration. The
NMPA database.
3. 1.5.8 Evidence of approval of applied Firm has also submitted differential fee of
formulation already approved by 45000/- vide slip No. 4265665526 dated
DRAP with brand name, 17-10-2022.
Registration number and
manufacturer name shall be
submitted.
submitted. Range.
provided.
While the accelerated stability data of three
batches i.e. ELNB210401, ELNB210501 &
ELNB210701 for 06 months is provided.
one year.
6. 3.2.P.2.2 In both Pharmaceutical Firm has submitted that in product
Equivalence and Comparative development data we have mentioned
Dissolution Profile two different details of brand leader as reference product
brand names are mentioned while which is REVLIMID CAPSULE
formulation development has manufactured by Celgene Corporation
mentioned product of Celgene Summit, NJ 07901, but, due to
pharma. In some places Beacon unavailability of this reference product in
pharma products are mentioned. Pakistan, we have performed
Clarification shall be submitted. pharmaceutical equivalence and
Comparative Dissolution Profile studies
against locally available brand i.e.,
Linamide Capsule manufactured by
Beacon Pharmaceuticals Limited
Bangladesh. This is in accordance with the
decision of Drug Registration Board taken
in its 307th meeting.
7. 3.2.P.2.2.1 Justification shall be submitted As per WHO, Annex 6, Multisource
regarding the selection of only two (generic) pharmaceutical products:
time points and paddle speed of 75 guidelines on registration requirements to
rpm in comparative dissolution establish interchangeability, 10.1.2
studies. Reference product has Determination of dissolution
used 50rpm and sampling time of characteristics of multisource products in
10, 15, 20, 30 & 45. consideration of a bio waiver based on the
Biopharmaceutics Classification System,
for very rapid release product use paddle
apparatus at 75 rpm therefore subjected
speed conducted for CDP. Also Minutes of
293rd Meeting of Registration Board (6 –
8th January, 2020), USFDA Guidance for
Industry Dissolution Testing of Immediate
Release Solid Oral Dosage Forms was
followed for guidance which states “with
the paddle method, it is 50-75 rpm (Shah et
al., 1992).” (Section 3.2.P.2.2.1). While
reference product manufacturer used 50
rpm for finish product dissolution testing
and we also performed the same for
submitted initial & stability studies.
Further regarding the selection of only two
time points, same above references are
adopted as the test product releases above
85% in 10 minutes then only further one-
time point included in report and
dissolution release achieved 85% for both
of test and reference products within 15
minutes due to this no need to calculate f2
factor therefore 3rd time point is not the part
of test report. Reference of above
guidelines attached in the section of
(3.2.P.2.2.1).
submitted.
9. 3.2.P.8 • Stability condition for real time Firm has submitted that they conduct
stability studies of the drug stability studies on more worst condition
product are 30°C ± 2°C / 75% ± than those data is also acceptable for
5%RH instead of 30°C ± 2°C / comparatively relaxed condition. As per
65% ± 5%RH. Justification shall policy we conduct the stability studies for
be submitted. real time as per Zone IV(b) requirement
Decision: Approved.
in the registration application.
In compliance to the aforementioned decision of the Authority, Assistant Director (PR-I/EFD) vide letter No.
F.1-6/2019-PR-I (EFD) dated 06th October, 2022 has informed that M/s Pharmedic Laboratories (Pvt.)
Ltd, Lahore has achieved the benchmark of more than 100,000 USD (1576776.335 USD) during the fiscal
Year 2019-2020 and submitted their applications for priority consideration/ evaluation.
434. Name, address of Applicant / Marketing Pharmedic Laboratories (Pvt.) Ltd., 16Km
Authorization Holder Multan Road, Lahore.
Name, address of Manufacturing site. Pharmedic Laboratories (Pvt.) Ltd., 16Km
Multan Road, Lahore.
☐ Importer
giver)
☐ Export sale
Dy. No. and date of submission Dy. No. 13722: dated 07-06-2022.
Details of fee submitted PKR 30,000/- vide slip No. 4235445044 dated
11-05-2022.
The proposed proprietary name / brand name Rovastin 5mg Tablet.
Strength / concentration of drug of Active Each film coated tablet contains;
Pharmaceutical ingredient (API) per unit Rosuvastatin as Calcium
…………………..5mg
Pharmaceutical form of applied drug Light yellow color, round, biconvex film coated
tablets.
Pharmacotherapeutic Group of (API) HMG CoA reductase inhibitors.
Reference to Finished product specifications USP specifications.
Proposed Pack size 10’s.
The status in reference regulatory authorities CRESTOR (rosuvastatin as calcium) 5mg,
10mg, 20 mg & 40 mg coated tablets, USFDA
approved.
For generic drugs (me-too status) Rovista tablet 5mg, Getz Pharma, Reg. No.
044043.
GMP status of the Finished product GMP certificate No. 93/2020-DRAP (AD-
manufacturer 2003099-790) dated 09-06-2020 issued on the
basis of inspection conducted on 04-02-2020 is
submitted.
Evidence of section approval. Tablet Non antibiotic, Antibiotic, Psychotropic,
Cephalosporin & Anit-Cancer are mentioned in
the above submitted GMP certificate.
Name and address of API manufacturer. Holder;
M/s Changzhou Pharmaceutical Factory, No.
518 East Laodong Road, Jiangsu Province
China.
GMP certificate No. JS20180848 issued by the
Jiangsu Food and Drug Administration valid till
09-07-2023 is provided.
Manufacturer;
M/s Nantong Chanyoo Pharmatech Co., Ltd.,
No. 2 Tonghai Si Road,v Yangkou chemical
industrial Park, Coastal Economic Development
Zone, Nantong, Jiangsu Province 226407,
China.
Copy of License for drug production in the name
of Nantong Chanyoo Pharmatech., Co., Ltd.,
with license No. Su20160512 issued by Jiangsu
Food and Drug Administration dated 03-12-
2020 is submitted.
Module-II (Quality Overall Summary) Firm has nor submitted QOS as per WHO QOS-
PD template.
process and controls, tests for impurities &
related substances, specifications, analytical
Stability studies (Drug substance.) Firm has submitted stability study data of 3
batches of drug substance at both accelerated as
well as real time conditions.
The accelerated stability data is conducted at
40°C ± 2°C / 75% ± 5% RH for 6 months.
The real time stability data is conducted at 30°C
± 2°C / 65 ± 5% RH for 24 months.
Batches:(RS-190308, RS-190309 & RS-
109311).
Module-III (Drug Product): Firm has submitted detail of drug product
pharmaceutical development, manufacturer,
process validation protocols, control of drug
analytical method verification studies, batch
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence is established
dissolution profile against the competitor product i.e. Rovista 5mg
tablets manufactured by M/s Getz Pharma
having batch No. 293F17, Exp. Date 10-2023 by
performing quality tests (Disintegration,
Dissolution, and Assay).
Rovista 5mg tablets manufactured by M/s Getz
Pharma having batch No. 293F17, Exp. Date 10-
2023 in three different mediums. F2 values for
all the three mediums are in acceptable range.
product. including linearity, range, accuracy, precision,
specificity.
Manufacturer of API Holder;
M/s Changzhou Pharmaceutical Factory, No. 518 East Laodong
Road, Jiangsu Province China.
GMP certificate No. JS20180848 issued by the Jiangsu Food and
Drug Administration valid till 09-07-2023 is provided.
Manufacturer;
M/s Nantong Chanyoo Pharmatech Co., Ltd., No. 2 Tonghai Si
Road,v Yangkou chemical industrial Park, Coastal Economic
Development Zone, Nantong, Jiangsu Province 226407, China.
Copy of License for drug production in the name of Nantong
Chanyoo Pharmatech., Co., Ltd., with license No. Su20160512
issued by Jiangsu Food and Drug Administration dated 03-12-2020
is submitted.
API Lot No. RS-701-200603.
Description of Pack
Alu-Alu blister sealed with Aluminum foil of 1×10’s.
Stability Storage Condition Long term: 30°C ± 2°C / 65% ± 5%RH
Time Period Long term: 6 months
Long term: 0, 3, 6, 9, 12 (Months)
Batch No. ROS5-TR005 ROS5-TR006 ROS5-TR007
Batch Size 1000 Tablets. 1000 Tablets. 1000 Tablets.
Manufacturing Date 02-2021. 02-2021. 02-2021.
Date of Initiation 10-03-2021. 15-12-2021. 15-12-2021.
No. of Batches 03
7. Reference of previous approval of applications Not submitted.
8. Approval of API/ DML/GMP certificate of Holder;
API manufacturer issued by concerned M/s Changzhou Pharmaceutical Factory, No.
regulatory authority of country of origin. 518 East Laodong Road, Jiangsu Province
China.
Manufacturer;
China.
2020 is submitted.
9. Documents for the procurement of API with Firm has submitted copy of commercial invoice
approval from DRAP (in case of import). No. CY120236 dated 10-06-2020 mentioning
Rosuvastatin calcium with quantity of 625gm,
Batch No. RS-701-200603 attested by Assistant
Director I&E DRAP, Lahore.
chromatograms,
etc.
11. Compliance Record of HPLC software 21CFR Not submitted.
Sr. Section Observations Reply by the firm
No.
1. 1.3.4 Valid copy of DML of the finished
product manufacturer shall be
submitted. As submitted one is w.e.f.
07-04-2010.
2. 1.6.5 Valid copy of GMP certificate for the
drug substance manufacturer issued by
the concerned/relevant regulatory
authority shall be submitted.
3. 2.3 Table of literature references has not
mention BP for drug substance. Table
of literature references has also shown
JP for the finished product.
Clarification shall be submitted.
4. 3.2.S.4.1 Drug substance manufacturer has used
Ph. Eur. specification for the drug
substance while drug product
manufacturer has used USP
specifications. Justification shall be
submitted.
5. 3.2.S.4.2 Analytical procedures provided by the
drug substance manufacturer are
different from that of the drug product
manufacturer. Justification shall be
submitted.
6. 3.2.S.4.3 Verification studies of the drug
substance performed by the drug
submitted.
7. 3.2.S.4.4 • Clear and readable copies of COAs
for the drug substance from drug
substance manufacturer shall be
submitted.
• Certificate of Analysis (COA) of the
same batch from Drug Substance /
API manufacturer shall also be
submitted
8. 3.2.S.5 Clear and readable copies of COAs for
the reference/working standard shall be
submitted.
9. 3.2.P.2 Qualitative composition of the applied
formulation is different from the
innovator product. Justification shall
be submitted.
10. 3.2.P.2.2 Justification shall be submitted for not
performing CDP and Pharmaceutical
equivalence against the innovator
product.
11. 3.2.P.5.1 • Specifications has mentioned
dissolution specification of NLT
75% Q while CDP has mentioned
NLT 80% Q. Justification shall be
submitted.
• Value for weight variation in the
specifications and stability data
sheets are different from each other.
Justify.
12. 3.2.P.8.3 • 06th month time point accelerated
stability study and real time stability
study for Batch No. ROS5-006 and
ROS5-007 shall be submitted.
• Date of manufacture on BMR and
stability data sheets are not similar.
• Reference of previous approval of
of the firm (if any) shall be
submitted.
testing shall be submitted.
Decision: Deferred for submission of above cited observations within six months.
☐ Importer
giver)
☐ Export sale
Details of fee submitted PKR 30,000/- vide slip No. 639696389234
dated 11-05-2022.
Pharmaceutical ingredient (API) per unit Rosuvastatin as Calcium
…………………..10mg
Pharmaceutical form of applied drug Pink color, round shaped biconvex film coated
tablets.
approved.
044044.
submitted.
China.
Manufacturer;
China.
2020 is submitted.
PD template.
40°C ± 2°C / 75% ± 5% RH for 6 months.
± 2°C / 65 ± 5% RH for 24 months.
Batches:(RS-190308, RS-190309 & RS-
109311).
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence is established
dissolution profile against the competitor product i.e. Rovista 10mg
tablets manufactured by M/s Getz Pharma
having batch No. 359F18, Exp. Date 01-2023 by
performing quality tests (Disintegration,
Dissolution, and Assay).
Rovista 10mg tablets manufactured by M/s Getz
Pharma having batch No. 359F18, Exp. Date 01-
2023 in three different mediums. F2 calculations
for Acetate buffer and phosphate buffer are not
performed. The values for f2 in 1.2 pH is in the
acceptable range.
product. including linearity, range, accuracy, precision,
specificity.
Manufacturer of API Holder;
M/s Changzhou Pharmaceutical Factory, No. 518 East Laodong
Road, Jiangsu Province China.
GMP certificate No. JS20180848 issued by the Jiangsu Food and
Drug Administration valid till 09-07-2023 is provided.
Manufacturer;
M/s Nantong Chanyoo Pharmatech Co., Ltd., No. 2 Tonghai Si
Road,v Yangkou chemical industrial Park, Coastal Economic
Development Zone, Nantong, Jiangsu Province 226407, China.
API Lot No. RS-701-200603.
Description of Pack
Alu-Alu blister sealed with Aluminum foil of 1×10’s.
Stability Storage Condition Long term: 30°C ± 2°C / 65% ± 5%RH
Time Period Long term: 6 months
Long term: 0, 3, 6, 9, 12 (Months)
Batch No. ROS10-TR005 ROS10-TR006 ROS10-TR007
Batch Size 1000 Tablets. 1000 Tablets. 1000 Tablets.
Manufacturing Date 02-2021. 02-2021. 02-2021.
Date of Initiation 10-03-2021. 15-12-2021. 15-12-2021.
No. of Batches 03
1. Reference of previous approval of applications Not submitted.
2. Approval of API/ DML/GMP certificate of GMP certificate of the Holder is submitted while
API manufacturer issued by concerned GMP certificate of the manufacturer is not
regulatory authority of country of origin. submitted.
3. Documents for the procurement of API with Firm has submitted copy of commercial invoice
approval from DRAP (in case of import). No. CY120236 dated 10-06-2020 mentioning
Rosuvastatin calcium with quantity of 625gm,
Batch No. RS-701-200603 attested by Assistant
Director I&E DRAP, Lahore.
chromatograms,
etc.
5. Compliance Record of HPLC software 21CFR Not submitted.
Sr. Section Observations Reply by the firm
No.
1. 1.3.4 Valid copy of DML of the finished
submitted. As submitted one is w.e.f.
07-04-2010.
2. 1.6.5 Valid copy of GMP certificate for the
drug substance manufacturer issued by
the concerned/relevant regulatory
authority shall be submitted.
3. 2.3 Table of literature references has not
mention BP for drug substance. Table
of literature references has also shown
JP for the finished product.
4. 3.2.S.4.1 Drug substance manufacturer has used
Ph. Eur. specification for the drug
substance while drug product
manufacturer has used USP
specifications. Justification shall be
submitted.
5. 3.2.S.4.2 Analytical procedures provided by the
drug substance manufacturer are
different from that of the drug product
manufacturer. Justification shall be
submitted.
6. 3.2.S.4.3 Verification studies of the drug
substance performed by the drug
submitted.
7. 3.2.S.4.4 • Clear and readable copies of COAs
for the drug substance from drug
substance manufacturer shall be
submitted.
• Certificate of Analysis (COA) of the
same batch from Drug Substance /
API manufacturer shall also be
submitted
8. 3.2.S.5 Clear and readable copies of COAs for
the reference/working standard shall be
submitted.
9. 3.2.P.2 Qualitative composition of the applied
formulation is different from the
innovator product. Justification shall
be submitted.
10. 3.2.P.2.2 • Justification shall be submitted for
not performing CDP and
Pharmaceutical equivalence against
the innovator product.
• F2 calculations for acetate buffer and
phosphate buffer shall be submitted.
11. 3.2.P.5.1 • Specifications has mentioned
dissolution specification of NLT
75% Q while CDP has mentioned
NLT 80% Q. Justification shall be
submitted.
• Value for weight variation in the
specifications and stability data
sheets are different from each other.
Justify.
12. 3.2.P.8.3 • Weight variation test in the stability
data is out of specification.
• Manufacturing date of batch No.
ROS10-006 is December, 2021 and
06th month time point accelerated
study shall be submitted.
• 06th month time point accelerated
study for Batch No. ROS10-007 shall
be submitted.
• Date of manufacture on BMR and
stability data sheets are not similar.
• Reference of previous approval of
of the firm (if any) shall be submitted.
testing shall be submitted.
Decision: Deferred for submission of above cited observations within six months.
☐ Importer
giver)
☐ Export sale
Details of fee submitted PKR 30,000/- vide slip No. 41094042890 dated
11-05-2022.
Pharmaceutical ingredient (API) per unit Rosuvastatin as Calcium ……………..20mg
Pharmaceutical form of applied drug White color, round shaped, biconvex core
tablets.
approved.
044045.
submitted.
China.
Manufacturer;
China.
2020 is submitted.
PD template.
40°C ± 2°C / 75% ± 5% RH for 6 months.
± 2°C / 65 ± 5% RH for 24 months.
Batches:(RS-190308, RS-190309 & RS-
109311).
analysis, justification of sp

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MINUTES OF 322nd MEETING OF REGISTRATION BOARD

HELD ON 8th & 10th November, 2022

Item No. Detail of Item Page No

I. Confirmation of Minutes of 321st meeting of Registration Board 2

II. Division of Pharmaceutical Evaluation & Registration

III. Miscelleneous cases 1650

Drug Regulatory Authority of Pakistan

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 1

Following members attended the meeting:

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 2

Item No. I: Confirmation of Minutes of 321st meetings of Registration Board.

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 3

Pharmaceutical Evaluation Cell (PEC)

Sr. No Name of Evaluator Title

14. Mr. Akbar Ali Evaluator PEC-XVI

15. Mr. Zia Ullah Evaluator PEC-XVII

16. Mr. Muneeb Ahmed Evaluator PEC-XVIII

17. Mst. Sana Kanwal Evaluator PEC-XX

18. Mr. Muhammad Zubair Assistant Director (PE&R)

19. Mr. Umer Latif

20. Mr. Ahsan Hafiz

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 4

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 6

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 9

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 10

COA for Sitagliptin from drug product

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 12

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 14

COA for Sitagliptin from drug product

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 15

CDP in all the three media with acceptable F2 values

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 17

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 18

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 20

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 21

4. Data of stability batches will be Submitted

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 22

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 30

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 31

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 32

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 33

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 34

3. Documents for the procurement of Empagliflozin:

4. Data of stability batches will be Submitted

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 35

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 38

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 41

Case No. II: Export facilitation

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 44

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 46

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 47

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 50

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 52

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 53

Sr. Shortcomings communicated Response by the firm

III: M/s Genix Pharma Pvt. Ltd.

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 55

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 56

Sr. Shortcomings communicated Response by the firm

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 59

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 61

Minutes of 322nd meeting of Registration Board (8th & 10th November,2022) 62

Sr. Shortcomings communicated Response by the firm

B: M/s Wilshire Laboratories (pvt) ltd.