Minutes of 330 Meeting of Registrationboard Held ON 24 TO 26 JULY, 2023

MINUTES OF 330TH MEETING OF REGISTRATIONBOARD HELD
ON 24TH TO 26TH JULY, 2023
Item Detail of Item Page No

No.
I. Division of Pharmaceutical Evaluation & Registration ---------

Pharmaceutical Evaluation Cell (PEC) ---------------------------- 03-1642
Registration-I Section ------------------------------------------------ 1642-1690
Registration-II Section ----------------------------------------------- 1690-1717
Post Registration-I Section ------------------------------------------ 1717-1728
Export Facilitation Desk---------------------------------------------- 1728-1733
Import & Vet-I Section ---------------------------------------------- 1733-1740
Import & Vet-II Section --------------------------------------------- 1740-1744
RRR Section ----------------------------------------------------------- 1744-1745
II. Division of Biological Evaluation & Research ------------------- 1746-1822

III. Division of Quality Assurance & Laboratory Testing ----------- 1823-1833
IV. Additional Agenda--------------------------------------------------- 1834-1910
V. Miscellaneous Cases------------------------------------------------- 1910-1917
Drug Regulatory Authority of Pakistan

T.F. Complex, Mauve Area, G-9/4
Islamabad.
------------
Minutes of 330th meeting of Registration Board (24th to 26th July, 2023) 1

330th meeting of Registration Board was held on 24th to 26th July, 2023 in the Committee
Room, Drug Regulatory Authority of Pakistan, G-9/4, Islamabad.
The meeting was chaired by Dr. Muhammad Fakhruddin Aamir, Chairman,
Registration Board, DRAP. The meeting started with recitation of the Holy Verses.
Following members attended the meeting:
Lt. Gen.(R) Prof. Dr. Karamat A. Karmat, (HI-M, SI-M),

1. Former Surgeon General Pakistan, Rawalpindi (On line) Co-opted
Member
Mr. Muhammad Aslam, Additional Draftsman, M/o Law &
2. Justice, Islamabad. Member
Dr. Imranullah Khan, Senior Drug Analyst. Rep of Director

3. DTL, Govt. of KP Member
4. Dr. Ayesha Yaqoob, DDC, Rep of Director DTL, Govt. of Member

Punjab
5. Dr. Ali Jan, Director, DTL, Govt. of Baluchistan Quetta Member
6. Mr. Ghulam Mujtaba, Rep. of IPO, Islamabad Member
7. Syed Adnan Rizvi, Director DTL. Govt. of Sindh. Karachi Member
8. Dr. Mahvash Ansari, Deputy Director, Rep. of Director, Member

QA&LT, DRAP, Islamabad.
9. Mr. Muhammad Kashif, Deputy Director, Rep. of Director, Member
Division of BE&R
10. Ch. Zeeshan Nazir Bajar, Additional Director Secretary
Hafiz Muhammad Asif Iqbal, Deputy Director, Rep. of
11. Director, MD&MC Division Member
12. Dr. Qurban Ali, Ex-Director General, NVL, Veterinary Co-opted

Expert Member
13. Dr. Khalid Ashfaque, Animal Husbandry Commissioner, M/o Co-opted
NFS, Islamabad. Member
Mr. Nadeem Alamgir & Dr. Aftab (Pharma Bureau), Mr. Jalal-ud-Din Zafar, Mr.
Uzair Nagra, Mr. Hamid Raza (PPMA) and Mr. Amir Ilyas (PCDA) attended the meeting as
observers.

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

1. Mr. Ammar Ashraf Awan Evaluator PEC-II
2. Dr. M. Haseeb Tariq Evaluator PEC-III
3. Mst. Farzana Raja Evaluator PEC-IV
4. Mst. Iqra Aftab Evaluator PEC-V
5. Mr. Adil Saeed Evaluator PEC-IX

6. Ms. Najia Saleem Evaluator PEC-X
7. Dr. Farhadullah Evaluator PEC-XI
8. Mr. Shahid Nawaz Evaluator PEC-XIII
9. Ms. Saima Hussain Evaluator PEC-XV

10. Ms. Sana Kanwal Evaluator PEC-XX
11. Mr. M. Tahir Waqas Evaluator PEC-XXI

12. Ms. Maham Misbah Evaluator PEC-XXIII
13. Mr. Muneeb Ahmed Cheema Deputy Director (PE&R)
14. Mr. Salateen Waseem Philip Deputy Director (PE&R)

Agenda of Evaluator PEC-II
Case no. 01: Contract manufacturering applications applied on Form-5F from a manufacturer
whose product development and stability data is already approved on Form 5F, by the Registration
Board:
Apixaban
1. Name, address of Applicant / Marketing M/s ICI Pakistan Limited ICI House, 5 West
Authorization Holder Wharf Karachi
Name, address of Manufacturing site. M/s Novamed Pharmaceuticals (Pvt.)Ltd ., 28km
Ferozepur Road Lahore
GMP status of the manufacturer GMP certificate garnted on 31/08/2021.
Evidence of approval of manufacturing facility License granted on 08/04/2006 and renewed on
08/04/2021 General tablet section approved and
Dy. No. and date of submission & Details of fee Dy.No 7965 dated 25-03-2022 Rs.75,000/- dated 28-
submitted 02-2022
The proposed proprietary name / brand name Linara 5mg Tablet
Strength / concentration of drug of Active Each Film coated Tablet Contains:
Pharmaceutical ingredient (API) per unit Apixaban ….…. 5mg
Pharmaceutical form of applied drug Film coated tablet
Pharmacotherapeutic Group of (API) Apixaban (Anticoagulant and direct inhibitor of
factor Xa.
Reference to Finished product specifications In-House
Proposed Pack size & Unit price As per SRO
The status in reference regulatory authorities Eliquis Tablet, Company: Bristol Myers
Squibb,USA
For generic drugs (me-too status) Apixaget tablet by Getz Pharma
Name and address of API manufacturer. Changzhou Pharmaceuticals Factory, 518
Laodong East Road,Changzhou,Jianngsu
Province,China.
Evaluation by PEC:
The applied product to be manufactured by M/s Novamed Pharmaceuticals(Pvt.) Ltd., 28km
Ferozepur Road Lahore have already been approved by Registration Board in its 320th meeting based on
the data of same batches of drug product as submitted in the instant case. The details of the already approved
product are as follows:
Applicant firm M/s Novamed Pharmaceuticals(Pvt.)Ltd ., 28km

Manufacturer firm M/s Novamed Pharmaceuticals(Pvt.)Ltd ., 28km
Brand Name Apixo Tablet 5 mg
Decision: The Board noted the information and decided to consider the application on its turn as per
Que or as per the direction of DRAP Authority, which ever is earlier.
2. Name, address of Applicant / Marketing M/s ICI Pakistan Limited ICI House, 5 West
Authorization Holder Wharf Karachi
Name, address of Manufacturing site. M/s Novamed Pharmaceuticals (Pvt.)Ltd ., 28km

GMP status of the manufacturer GMP certificate garnted on 31/08/2021.
Evidence of approval of manufacturing facility License granted on 08/04/2006 and renewed on
08/04/2021 General tablet section approved and
submitted 02-2022
The proposed proprietary name / brand name Linara 2.5mg Tablet
Strength / concentration of drug of Active Each Film coated Tablet Contains:
Pharmaceutical ingredient (API) per unit Apixaban ….…. 2.5mg
Pharmacotherapeutic Group of (API) Apixaban (Anticoagulant and direct inhibitor of
factor Xa.
Reference to Finished product specifications In-House
The status in reference regulatory authorities Eliquis Tablet, Company: Bristol Myers
Squibb,USA
For generic drugs (me-too status) Apixaget tablet by Getz Pharma
Name and address of API manufacturer. Changzhou Pharmaceuticals Factory, 518
Laodong East Road,Changzhou,Jianngsu
Province,China.
Evaluation by PEC:
The applied product to be manufactured by M/s Novamed Pharmaceuticals(Pvt.) Ltd., 28km
Ferozepur Road Lahore have already been approved by Registration Board in its 320th meeting based on
Applicant firm M/s Novamed Pharmaceuticals(Pvt.)Ltd ., 28km

Manufacturer firm M/s Novamed Pharmaceuticals(Pvt.)Ltd ., 28km
Brand Name Apixo Tablet 2.5 mg
Azilsartan Medoxomil
3. Name, address of Applicant / Marketing M/s Horizon Healthcare (Pvt) Ltd.
Authorization Holder Plot No.35-A, Small Industrial Estate, Taxila,
Pakistan
Name, address of Manufacturing site. M/s Horizon Healthcare (Pvt) Ltd.
Plot No. 33, Sundar Industrial Estate, Lahore
GMP status of the manufacturer Last inspection report dated 18.06.2020
concluded good level of cGMP compliance.
Evidence of approval of manufacturing facility Tablet section approval letter submitted from M.
Horizon Helathcare Lahore (Ex Walt Danay)
submitted 07-2023
The proposed proprietary name / brand name Azilaar 80mg Tablet

Strength / concentration of drug of Active Each tablet contains:
Pharmaceutical ingredient (API) per unit Azilsartan Medoxomil (as Potassium) …….80mg
Pharmaceutical form of applied drug White to off white biconvex round shape Tablets.
Pharmacotherapeutic Group of (API) Angiotensin II receptor antagonists.
Reference to Finished product specifications Innovator’s
The status in reference regulatory authorities Edarbi 80mg tablet approved by US FDA
For generic drugs (me-too status) Not available
Name and address of API manufacturer. M/s CTX Life Sciences 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
Sachin, Surat-394 230 Gujarat, India
Evaluation by PEC:
The applied product to be manufactured by M/s Horizon Healthcare (Pvt) Ltd. Plot No. 33, Sundar
Industrial Estate, Lahore have already been approved by Registration Board in its 320 th meeting based on
Applicant firm M/s Horizon Healthcare (Pvt) Ltd. Plot No. 33, Sundar
Industrial Estate, Lahore
Manufacturer firm M/s Horizon Healthcare (Pvt) Ltd. Plot No. 33, Sundar
Brand Name Azilsartan Medoxomil 80mg Tablet
Pakistan
submitted 07-2023
The proposed proprietary name / brand name Azilaar 40mg Tablet
The status in reference regulatory authorities Edarbi 40mg tablet approved by US FDA

Name and address of API manufacturer. M/s CTX Life Sciences 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
Sachin, Surat-394 230 Gujarat, India
Evaluation by PEC:
Brand Name Azilsartan Medoxomil 40mg Tablet
5. Name, address of Applicant / Marketing M/s Weather Folds Pharmaceuticals.
Authorization Holder Plot # 69, Phase-II, Industrial Estate, Hattar
Name, address of Manufacturing site. M/s Wnsfeild Pharmaceuticals.
Plot # 122, Block A, Phase V, Hattar Industrial Estate,
Hattar
GMP status of the manufacturer GMP inspection conducted on 10/12/2020
Evidence of approval of manufacturing facility GMP inspection conducted on 10/12/2020
Tablet (General & General Antibiotic) section
approved.
submitted 07-2023
The proposed proprietary name / brand name Azzota 40mg Tablet
The status in reference regulatory authorities Edarbi 40mg tablet approved b US FDA
For generic drugs (me-too status) N/A
Name and address of API manufacturer.
CTX Lifesciences (P) Ltd. India
Evaluation by PEC:

The applied product to be manufactured by M/s WnsFeild Pharmaceutical Industrial Estate Hattar Haripur
Kpk Pakistan have already been approved by Registration Board in its 326th meeting based on the data of
same batches of drug product as submitted in the instant case. The details of the already approved product
are as follows:
Applicant firm M/s WnsFeild Pharmaceutical Industrial Estate Hattar Haripur

Kpk Pakistan.
Manufacturer firm M/s WnsFeild Pharmaceutical Industrial Estate Hattar Haripur
Kpk Pakistan.
Brand Name AZILTA 40MG TABLET
Hattar
approved.
submitted 07-2023
The proposed proprietary name / brand name Azzota 80mg Tablet
Evaluation by PEC:
Kpk Pakistan have already been approved by Registration Board in its 326 th meeting based on the data of
are as follows:

Kpk Pakistan.
Kpk Pakistan.

7. Name, address of Applicant / Marketing M/s Winbrains Research Laboratories.
Authorization Holder Plot No. 69/1, Block B, Phase I-II, Industrial Estate,
Hattar, Pakistan
Hattar
approved.
submitted 07-2023
The proposed proprietary name / brand name Azzilta 40mg Tablet
Evaluation by PEC:
are as follows:

Kpk Pakistan.
Kpk Pakistan.
Hattar, Pakistan
Hattar
approved.
submitted 07-2023

The proposed proprietary name / brand name Azzilta 80mg Tablet
Evaluation by PEC:
are as follows:

Kpk Pakistan.
Kpk Pakistan.
Azilsartan/Chlorthalidone
Pakistan
Status of application ☐ New Drug Product (NDP)
☒ Generic Drug Product (GDP)
Intended use of pharmaceutical product ☐ Domestic sale
☐ Export sale
☒ Domestic and Export sales
submitted 07-2023
The proposed proprietary name / brand name Azilaar-C 40/12.5 mg Tablet
Strength / concentration of drug of Active Each Film Coated tablet contains:
Pharmaceutical ingredient (API) per unit Azilsartan Medoxomil as Potassium .................. 40mg
Chlorthalidone …………….. 12.5mg

Pharmaceutical form of applied drug Film coated tablets
Pharmacotherapeutic Group of (API) Azilsartan Medoxomil Potassium: Angiotensin II
antagonist
Chlorthalidone: Benzothiadiazine Diuretic
Reference to Finished product specifications As per innovator
The status in reference regulatory authorities EDARBYCLOR Tablet 40mg/12.5mg approved
by US-FDA
Name and address of API manufacturer. Azilsartan Medoxomil Potassium: CTX Life
Sciences Pvt Ltd
Block no: 251-252-Sachin-Magdalla Road GIDC
Sachin, Surat-394 230 Gujrat India
Chlorthalidone: Menadiaona S.L
Poligon Industrial Mas Puigvert s/n,08389 Palafolls,
Barcelona, Spain
Evaluation by PEC:
Industrial Estate, Lahore have already been approved by Registration Board in its 326th meeting based on
Brand Name Azila-C Tablet 40/12.5
Pakistan
Evidence of approval of manufacturing facility Tablet section approval letter submitted from M/s
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Azilaar-C 40/25 mg Tablet
Strength / concentration of drug of Active Each Film Coated tablet contains:
Pharmaceutical ingredient (API) per unit Azilsartan Medoxomil as Potassium .................. 40mg

Chlorthalidone …………….. 25mg
Pharmacotherapeutic Group of (API) Azilsartan Medoxomil Potassium: Angiotensin II
antagonist
Chlorthalidone: Benzothiadiazine Diuretic
The status in reference regulatory authorities EDARBYCLOR Tablet 40mg/25mg approved
by US-FDA
Name and address of API manufacturer. Azilsartan Medoxomil Potassium: CTX Life
Sciences Pvt Ltd
Block no: 251-252-Sachin-Magdalla Road GIDC
Sachin, Surat-394 230 Gujrat India
Chlorthalidone: Menadiaona S.L
Poligon Industrial Mas Puigvert s/n,08389 Palafolls,
Barcelona, Spain
Evaluation by PEC:
Brand Name Azila-C Tablet 40/25
Beclomethasone Dipropionate
11. Name, address of Applicant / Marketing M/s Pharmevo Private Limited.
Authorization Holder Plot # A-29, North Western Industrial Zone, Port
Qasim, Karachi
Name, address of Manufacturing site. M/s Hudson Pharma Private Limited.
Site-Plot No. D-93, North Western Industrial Zone,
Port Qasim Authority, Pakistan
GMP status of the manufacturer New section granted on 24/11/2021
Injectable Ampoule BF (steroid) -
Evidence of approval of manufacturing facility New section granted on 24/11/2021
☐ Export sale

submitted 03-2023
The proposed proprietary name / brand name Becson 0.8mg/2ml Nebulization Suspension
Strength / concentration of drug of Active Each 2ml of Suspension Contains:
Pharmaceutical ingredient (API) per unit Beclomethasone Dipropionate…0.8mg
Pharmaceutical form of applied drug Suspension for Nebulisation
Pharmacotherapeutic Group of (API) Corticosteroid
Reference to Finished product specifications In-house
The status in reference regulatory authorities Product is registered in Italian Medicine
Agency (AIFA), with the brand name “Clenil”
by Chiesi Farmaceutici, Italy.
For generic drugs (me-too status) Manufacturer name: Chiesi Farmaceutici, Italy.
Importer: Chiesi Pharmaceutical (Pvt.) Ltd.
Brand name: Clenil,
Strength: 0.8mg/2ml,
Registration number: 014091
Name and address of API manufacturer. FARMABIOS S.p.A.Via Pavia, 1 27027
Gropello Cairoli, (PV) Italy.
Evaluation by PEC:
The applied product to be manufactured by M/s Hudson Pharma Private Limited Site-Plot No. D-93, North
Western Industrial Zone, Port Qasim Authority, Pakistan have already been approved by Registration
Board in its 320th meeting based on the data of same batches of drug product as submitted in the instant
case. The details of the already approved product are as follows:
Applicant firm M/s Hudson Pharma Private Limited.

Site-Plot No. D-93, North Western Industrial Zone, Port
Qasim Authority, Pakistan
Manufacturer firm M/s Hudson Pharma Private Limited.
Brand Name Becloson Suspension for Nebulisation 0.8mg/2ml
Bempedoic Acid
Pakistan

☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Bemzeox 180mg Tablet
Strength / concentration of drug of Active Each Film Coated Tablet Contains:
Pharmaceutical ingredient (API) per unit Bempedoic Acid…180mg
Pharmacotherapeutic Group of (API) Bempedoic Acid: Lipid modifying agents, other
lipid modifying agents. Adenosine triphosphate
citrate lyase (ACL) inhibitor
The status in reference regulatory authorities Nexlitol Tablets 180mg approved by US-FDA
Name and address of API manufacturer. 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).
Evaluation by PEC:
Industrial Estate, Lahore have already been approved by Registration Board in its 322 nd meeting based on
Brand Name Bempex Tablet 180mg
13. Name, address of Applicant / Marketing M/s CCL Pharmaceuticals Pvt Ltd.
Authorization Holder 62 Industrial Estate,Kot Lakhpat,Lahore

☐ Export sale
submitted 11-2022
The proposed proprietary name / brand name Nexle 180mg Tablet
Pharmaceutical ingredient (API) per unit Bempedoic Acid…180mg
Name and address of API manufacturer. Metrochem API Private Limited, Unit-IV,
Plot No. 34B, 40B & 60B, J.N. Pharma City,
Thanam Village, Parawada Mandal,
Visakhapatnam District,
India (IND).
Evaluation by PEC:
Industrial Estate, Lahore have already been approved by Registration Board in its 322 nd meeting based on
Brand Name Bempex Tablet 180mg
Bempedoic acid/Ezetimibe
Pakistan

submitted 07-2023
The proposed proprietary name / brand name Bemzeox-E 180/10 mg Tablet
Strength / concentration of drug of Active Each Film Coated Tablet contains:
Pharmaceutical ingredient (API) per unit Bempedoic Acid…….180mg
Ezetimibe……………...10mg
Ezetimibe: adenosine triphosphate-citrate lyase
(ACL)
inhibitor, Cholesterol absorption inhibitor.
The status in reference regulatory authorities Nexilzet tablet approved by US FDA
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,
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.
Evaluation by PEC:
Industrial Estate, Lahore have already been approved by Registration Board in its 322nd meeting based on
Brand Name Bempp-z 180/10mg tablet
Budesonide
15. Name, address of Applicant / Marketing M/s Pharmevo Private Limited.
Authorization Holder Plot # A-29, North Western Industrial Zone, Port
Qasim, Karachi
Name, address of Manufacturing site. M/s Hudson Pharma Private Limited.
Site-Plot No. D-93, North Western Industrial Zone,
Port Qasim Authority, Pakistan

GMP status of the manufacturer GMP inspection conducted on 07th October
2021
Evidence of approval of manufacturing facility New section granted on 24/11/2021
☐ Export sale
submitted 03-2023
The proposed proprietary name / brand name Bunide 1mg/2ml Inhalation
Strength / concentration of drug of Active Each 2 ml Respule contains:
Pharmaceutical ingredient (API) per unit Budesonide…….1mg
Pharmaceutical form of applied drug Suspension for inhalation
Pharmacotherapeutic Group of (API) Corticosteroid
Reference to Finished product specifications BP specification
The status in reference regulatory authorities MHRA approved
Pulmicort Inhalation Suspension 1mg/2ml
(Manufacturer: AstraZeneca)
Name and address of API manufacturer. Industriale Chimica S.R.L Via E.H Grieg,13-
21047 SARONNO (VA)
Evaluation by PEC:
The applied product to be manufactured by M/s Hudson Pharma Private Limited Site-Plot No. D-93, North
Western Industrial Zone, Port Qasim Authority, Pakistan have already been approved by Registration
Board in its 322nd meeting based on the data of same batches of drug product as submitted in the instant
Applicant firm M/s Hudson Pharma Private Limited.

Manufacturer firm M/s Hudson Pharma Private Limited.
Brand Name Actonide Suspension for Nebulisation 1mg/2ml
Cefixime
16. Name, address of Applicant / Marketing M/s Health Care Pharmaceuticals.

Authorization Holder 40-Km Lahore Road, Multan

Name, address of Manufacturing site. M/s Cunningham Pharmaceuticals Pvt Ltd.
Plot # 81, Sunder Industrial Estate, Raiwind Road
Lahore, Pakistan
GMP status of the manufacturer Firm has submitted copy of GMP certificate of M/s
Cunningham Pharmaceuticals (Pvt) Ltd dated 19-04-
2019 based on the inspection dated 01-04-2019.
The GMP certificate specifies Dry powder suspension
(cephalosporin) section.
Evidence of approval of manufacturing facility Firm has submitted copy of letter for issuance of DML
of M/s Cunningham Pharmaceuticals (Pvt) Ltd dated
13-06-2016 specifying Dry Powder suspension
☐ Export sale
submitted 04-2023
The proposed proprietary name / brand name Bectaxime 200mg/5ml Dry Suspension
Strength / concentration of drug of Active Each 5ml of reconstituted suspension contains:
Pharmaceutical ingredient (API) per unit Cefixime (as trihydrate)……200mg
Pharmaceutical form of applied drug Dry powder suspesnion
Pharmacotherapeutic Group of (API) Cephalosporin antibiotic
Reference to Finished product specifications USP specs
The status in reference regulatory authorities Suprax suspension 200mg/5ml (USFDA Approved)
For generic drugs (me-too status) Tripsan 200mg/5ml dry suspension by Seraph
Pharmaceuticals
Name and address of API manufacturer. Pharmagen Limited. Kot Nabi Bukshwala, 34 Km,
Ferozepur Road, Lahore.
Evaluation by PEC:
The applied product to be manufactured by M/s Cunningham Pharmaceuticals (Pvt) Ltd. Plot No. 81,
Sunder Industrial Estate, Lahore have already been approved by Registration Board in its 2323 rd meeting
based on the data of same batches of drug product as submitted in the instant case. The details of the already
approved product are as follows:
Applicant firm M/s PDH Laboratories (Pvt) Ltd. 9.5Km Sheikhupura Road
Lahore.
Manufacturer firm M/s Cunningham Pharmaceuticals (Pvt) Ltd. Plot No. 81,
Sunder Industrial Estate, Lahore.
Brand Name Pdfim 100mg/5ml
Lahore, Pakistan

The GMP certificate specifies Dry powder suspension
13-06-2016 specifying Dry Powder suspension
☐ Export sale
submitted 04-2023
The proposed proprietary name / brand name Bectaxime 100mg/5ml Dry Suspension
Pharmaceutical form of applied drug Dry powder suspesnion
Pharmaceuticals
Evaluation by PEC:
Lahore.
Brand Name Pdfim 100mg/5ml
Lahore, Pakistan

The GMP certificate specifies Capsule
13-06-2016 specifying capsule (cephalosporin)
section.
☐ Export sale
submitted 04-2023
The proposed proprietary name / brand name Bectaxime 400mg Capsule
Strength / concentration of drug of Active Each capsule contains:
Pharmaceutical form of applied drug Capsule contained in Alu Alu blister
Reference to Finished product specifications JP specs
The status in reference regulatory authorities Suprax Capsule 400mg (USFDA Approved)
For generic drugs (me-too status) Tripsan 400mg capsule by Seraph Pharmaceuticals
Evaluation by PEC:
Lahore.
Brand Name Pdfim 400mg capsule
19. Name, address of Applicant / Marketing M/s Welwrd Pharmaceuticals.
Authorization Holder Plot # 3, Block A, Phase I-II, Industrial Estate
Hattar, KPK
Name, address of Manufacturing site. M/s Bio-Labs (Pvt) Ltd. Plot No. 145, Industrial
Triangle Kahuta Road Islamabad.
GMP status of the manufacturer Firm has been granted new license (DML No. 000911)
by way of formulation dated 13-02-2020.
Evidence of approval of manufacturing facility Firm has submitted copy of section approval letter
dated 14-02-2020 which specifies Dry Powder
suspension section (Cephalosporin).

☐ Export sale
submitted 03-2022
The proposed proprietary name / brand name Cefixime 200mg/5ml DS
Pharmaceutical form of applied drug Amber colored glass bottle containing white to off
white powder for reconstitution volume 30ml (after
reconstitution)
Pharmaceuticals
Name and address of API manufacturer. Saakh Pharma (Pvt) Ltd. C-7/1, North Western
Industrial Zone, Port Qasim, Karchi.
Evaluation by PEC:
The applied product to be manufactured by M/s Bio-Labs (Pvt) Ltd. Plot No. 145, Industrial Triangle
Kahuta Road Islamabad have already been approved by Registration Board in its 297 th meeting based on
Applicant firm M/s Variant Pharmaceuticals Pvt Ltd. Plot No. 5, M2-Pharma
Zone Lahore, Sharikpur Road, Sheikhupura
Manufacturer firm M/s Bio-Labs (Pvt) Ltd. Plot No. 145, Industrial Triangle
Kahuta Road Islamabad.
Brand Name VARICEF 200mg/5ml Dry Suspension
20. Name, address of Applicant / Marketing M/s Bio-next Pharmaceuticals.
Authorization Holder Plot No. 50, Street No. S-10, RCCI, Rawat
Bio-Labs dated 21-05-2019 based on the inspection
dated 23-04-2019. The certificate is valid till 22-04-
2022.
Evidence of approval of manufacturing facility Firm has submitted copy of GMP certificate of M/s
2022.
The GMP certificate specifies oral dry powder
suspension (cephalosporin) section.

☐ Export sale
submitted 10-2021
The proposed proprietary name / brand name Fixen 100mg/5ml DS
reconstitution)
Pharmaceuticals
Evaluation by PEC:
☐ Export sale
submitted 10-2021

The proposed proprietary name / brand name Fixen 200mg/5ml Dry Suspension
reconstitution)
Pharmaceuticals
Evaluation by PEC:
22. Name, address of Applicant / Marketing M/s ICU Pharmaceuticals.
Authorization Holder Khewat 13/13, Khatooni No. 57/66, Mouza Mirpur
Kehna, Tehsil Sharakpur, District Sheikhupura
Name, address of Manufacturing site. M/s Biogen Life Sciences. 8-Km, Chakbeli Road,
Rawat, Rawalpindi, Pakistan
☐ Export sale
submitted 09-2022
The proposed proprietary name / brand name Xec-Xim 100mg/5ml Dry Suspensio

reconstitution)
Pharmaceuticals
Evaluation by PEC:
The applied product to be manufactured by M/s Biogen Life Sciences 8-Km, Chakbeli Road, Rawat,
Rawalpindi, Pakistan have already been approved by Registration Board in its 297th meeting based on the
data of same batches of drug product as submitted in the instant case. The details of the already approved
Applicant firm M/s Biogen Pharmaceuticals 8Km, Chakbeli Road Rawat,

Rawalpindi
Manufacturer firm M/s Biogen Pharmaceuticals 8Km, Chakbeli Road Rawat,
Rawalpindi
Brand Name CARECEF 100mg/5ml Dry Suspension
Note: The title of the manufacturer was changed to M/s Biogen Life Sciences 8-Km, Chakbeli
Road, Rawat, Rawalpindi, Pakistan
☐ Export sale
submitted 09-2022
The proposed proprietary name / brand name Xec-Xim 200mg/5ml Dry Suspensio
reconstitution)

Pharmaceuticals
Evaluation by PEC:
Rawalpindi, Pakistan have already been approved by Registration Board in its 297 th meeting based on the

Rawalpindi
Rawalpindi
Brand Name CARECEF 200mg/5ml Dry Suspension
dated 14-02-2020 which specifies Capsule section
(Cephalosporin).
☐ Export sale
submitted 09-2022
The proposed proprietary name / brand name Xec-Xim 400mg Capsule
Strength / concentration of drug of Active Each caspsule contains:
Pharmaceutical form of applied drug Hard gelatin capsule

For generic drugs (me-too status) Caricef capsule of M/s Sami
Evaluation by PEC:

Rawalpindi
Rawalpindi
Brand Name CARECEF 400mg capsule
25. Name, address of Applicant / Marketing M/s Unimark Pharmaceuticals Pvt Ltd.
Authorization Holder Plot No. 7--A, Street No. S-7, National Industrial
Zone, Rawat, Islamabad, Pakistan
Name, address of Manufacturing site. M/s Seraph Pharmaceuticals.
Plot No. 210, Industrial Triangle, Kahuta Road,
Islamabad
GMP status of the manufacturer Seraph Pharmaceuticals: GMP certificate issued on
the basis of inspection conducted on 11/07/2019.
Evidence of approval of manufacturing facility Firm (M/s Seraph Pharmaceuticals) has submitted
copy of Issuance of DML letter dated 12-06-2017
specifying Dry powder suspension Cephalosporin
section.
☐ Export sale
submitted 03-2022
The proposed proprietary name / brand name Unicef 200mg/5ml Dry Suspension
reconstitution)

Pharmaceuticals
Industrial Zone Port Qasim Karachi.
Evaluation by PEC:
The applied product to be manufactured by M/s Seraph Pharmaceuticals Islamabad have already been
approved by Registration Board in its 297th meeting based on the data of same batches of drug product as
submitted in the instant case. The details of the already approved product are as follows:
Applicant firm M/s Moringa Pharmaceuticals 35-A, Sunder Industrial Estate,

Lahore
Manufacturer firm M/s Seraph Pharmaceuticals Plot No. 210, Industrial Triangle,
Kahuta Road, Islamabad
Brand Name Saf-Xime 200mg/5ml Dry suspension
26. Name, address of Applicant / Marketing M/s Pine Pharmaceuticals.
Authorization Holder Plot No. 40, Street No. S-4, RCCI, Industrial
Estate, Rawat
Islamabad
section.
☐ Export sale
submitted 05-2022
The proposed proprietary name / brand name Pinefix 200mg/5ml Dry Suspension
reconstitution)
Pharmaceuticals

Evaluation by PEC:

Lahore
Estate, Rawat
Islamabad
section.
☐ Export sale
submitted 05-2022
The proposed proprietary name / brand name Pinefix 100mg/5ml Dry Suspension
reconstitution)
Pharmaceuticals
Evaluation by PEC:


Lahore
Islamabad
section.
☐ Export sale
submitted 03-2022
The proposed proprietary name / brand name Unicef 100mg/5ml Dry Suspension
reconstitution)
Pharmaceuticals
Evaluation by PEC:

Lahore
Estate, Rawat
Islamabad
specifying Capsule Cephalosporin section.
☐ Export sale
submitted 05-2022
The proposed proprietary name / brand name Pinefix 400mg Capsule
Evaluation by PEC:

Lahore
Brand Name Saf-Xime 400mg Capsule

Islamabad
specifying Capsule Cephalosporin section.
☐ Export sale
submitted 03-2022
The proposed proprietary name / brand name Unicef 400mg Capsule
Evaluation by PEC:

Lahore
Brand Name Saf-Xime 400mg Capsule
31. Name, address of Applicant / Marketing M/s Jaskan Pharmaceuticals Pvt Ltd
Authorization Holder 5- Sundar Industrial Estate, Lahore
Lahore, Pakistan
Status of the applicant ☐ Manufacturer
☐ Importer

☒ Is involved in none of the above (contract giver)
Cunningham Pharmaceuticals (Pvt) Ltd dated 19-
04-2019 based on the inspection dated 01-04-2019.
The GMP certificate specifies Capsule
Evidence of approval of manufacturing facility Firm has submitted copy of letter for issuance of
DML of M/s Cunningham Pharmaceuticals (Pvt)
Ltd dated 13-06-2016 specifying capsule
☐ Export sale
Dy. No. and date of submission Dy.No 7367 dated 16-03-2022
Details of fee submitted Rs.75,000/- dated 18-01-2022
The proposed proprietary name / brand name Cefixa 400mg Capsule
Strength / concentration of drug of Active Each Capsule Contains:
Pharmaceutical ingredient (API) per unit Cefixime as Trihydrate…400mg
Pharmaceutical form of applied drug Hard gelatin capsule size # 0 with blue colored body
and cap having white to yellow colored powder
Pharmacotherapeutic Group of (API) Cephalosporin Antibiotic
Reference to Finished product specifications JP specification
Proposed Pack size 1x5’s
Proposed unit price As per SRO
The status in reference regulatory authorities Cefixime 400mg capsule (MHRA Approved)
For generic drugs (me-too status) Cefim Capsule by Hilton
Evaluation by PEC:
The applied product to be manufactured by M/s Cunningham Pharmaceuticals Pvt Ltd.Plot # 81, Sunder
Industrial Estate, Raiwind Road Lahore, Pakistan has already been approved by Registration Board in its
323rd meeting based on the data of same batches of drug product as submitted in the instant case. The details
of the already approved product in 323rd meeting are as follows:
Lahore.
Brand Name PDFIM 400mg Capsule
Cefoperazone Sodium/Sulbactam Sodium
Name, address of Applicant / Marketing M/s ICU Pharmaceuticals.

32. Authorization Holder Khewat 13/13, Khatooni No. 57/66, Mouza Mirpur
dated 14-02-2020 which specifies Cephalosporin dry
powder injection section.
☐ Export sale
submitted 09-2022
The proposed proprietary name / brand name Cefo-Bact 2gm Injection
Strength / concentration of drug of Active Each Vial Contains:
Pharmaceutical ingredient (API) per unit Cefoperazone as Sodium…1000mg
Sulbactam as Sodium…1000mg
Pharmaceutical form of applied drug Sterile white to almost white powder filled in
transparent glass vials
The status in reference regulatory authorities As per SRO
For generic drugs (me-too status) Sulperazone Intravenous Injection 2g (PMDA Japan
Approved)
Name and address of API manufacturer. Cefbac injection by Seraph Pharmaceuticals
Evaluation by PEC:
Applicant firm M/s Biogen Life Sciences 8-Km, Chakbeli Road, Rawat,
Rawalpindi, Pakistan
Manufacturer firm M/s Biogen Life Sciences 8-Km, Chakbeli Road, Rawat,
Brand Name Sulgen 2gm IM/IV Injection
Name, address of Manufacturing site. M/s Biogen Life Sciences 8-Km, Chakbeli Road,

dated 14-02-2020 which specifies Cephaosporin dry
powder injection section.
☐ Export sale
submitted 09-2022
The proposed proprietary name / brand name Cefo-Bact 1gm Injection
Approved)
Evaluation by PEC:
Applicant firm M/s Biogen Life Sciences 8-Km, Chakbeli Road, Rawat,
Manufacturer firm M/s Biogen Life Sciences 8-Km, Chakbeli Road, Rawat,
Brand Name Sulgen 1gm IM/IV Injection
34. Name, address of Applicant / Marketing M/s Linta Pharmaceuticals Pvt Ltd.
Authorization Holder Plot No. 03, Street No S-5, National Industrial
Zone, Rawat, Islamabad
Islamabad
specifying Dry Vial Cephalosporin section.

☐ Export sale
submitted 03-2022
The proposed proprietary name / brand name Cefsal 2gm IV/IM Injection
Approved)
Evaluation by PEC:
Applicant firm M/s Carer Pharmaceutical Industries. Plot No. 27 Main Road,
Rawat Industrial Estate, Rawat, Pakistan
Brand Name CEFCAR 2gm IM/IV Injection
Islamabad
☐ Export sale
submitted 03-2022
The proposed proprietary name / brand name Cefsal 1gm IV/IM Injection

Approved)
Evaluation by PEC:
Applicant firm M/s Carer Pharmaceutical Industries. Plot No. 27 Main

Road, Rawat Industrial Estate, Rawat, Pakistan
Brand Name CEFCAR 1gm IM/IV Injection
Ceftriaxone Sodium
36. Name, address of Applicant / Marketing M/s Venus Pharma.
Authorization Holder 23 km, Multan Road, Lahore
Name, address of Manufacturing site. M/s Cunningham Pharmaceuticals (Pvt) Ltd. Plot No.
81, Sunder Industrial Estate, Lahore.
Cunningham Pharmaceuticals dated 19-04-2019
based on the inspection dated 01-04-2019. The
certificate was valid till 01-04-2022.
The GMP certificate specifies dry powder injection
Evidence of approval of manufacturing facility Firm has submitted copy of letter of issuance of Drug
Manufacturing License to M/s Cunningham
Pharmaceuticals dated 13-06-2016. The letter
specifies dry powder injection (cephalosporin)
section.
☐ Export sale
submitted 06-2023

The proposed proprietary name / brand name Xinva 2gm IV Dry Powder For Injection
Strength / concentration of drug of Active Each vial contains:
Pharmaceutical ingredient (API) per unit Ceftriaxone (as sodium)……2gm
Pharmaceutical form of applied drug Sterilized white to off white crystalline dry powder
contained in a glass vial with sterilized rubber stopper
& aluminium flip seal on it.
The status in reference regulatory authorities Ceftriaxone powder for solution for injection (MHRA
Approved)
For generic drugs (me-too status) Oxidil Injection of M/s Sami
Name and address of API manufacturer. Zhuhai United Laboratories Co. Ltd. No. 2428, Anji
Road, Sanzao Town, Jinwan District Zhuhai
Guangdong P.R China.
Evaluation by PEC:
Sunder Industrial Estate, Lahore have already been approved by Registration Board in its 323rd meeting
Applicant firm M/s Genetics Pharmaceuticals (Pvt) Ltd. 539-A, Sunder

Industrial Estate, Lahore.
Brand Name Genxone 2gm IV injection
section.
☐ Export sale
submitted 06-2023

The proposed proprietary name / brand name Xinva 250mg IM Dry Powder For Injection
Pharmaceutical ingredient (API) per unit Ceftriaxone (as sodium)……250mg
Approved)
Evaluation by PEC:

Brand Name Genxone 250mg IM injection
section.
☐ Export sale
submitted 06-2023

The proposed proprietary name / brand name Xinva 1gm IM Dry Powder For Injection
Approved)
Evaluation by PEC:

Brand Name Genxone 1gm IM injection
section.
☐ Export sale
submitted 04-2023

The proposed proprietary name / brand name Cuxone 500mg IV Injection
Approved)
Evaluation by PEC:

Brand Name Genxone 5 IV injection
section.
☐ Export sale
submitted 04-2023

The proposed proprietary name / brand name Cuxone 1gm IV Injection
Approved)
Evaluation by PEC:

section.
☐ Export sale
submitted 04-2023

The proposed proprietary name / brand name Cuxone 1gm IM Injection
Approved)
Evaluation by PEC:

Brand Name Genxone 1gm IM injection
section.
☐ Export sale
submitted 04-2023

The proposed proprietary name / brand name Cuxone 2gm IV Injection
Approved)
Evaluation by PEC:

section.
☐ Export sale
submitted 04-2023

The proposed proprietary name / brand name Cuxone 500mg IM Injection
Approved)
Evaluation by PEC:
Sunder Industrial Estate, Lahore have already been approved by Registration Board in its 324th meeting

section.
☐ Export sale
submitted 04-2023

The proposed proprietary name / brand name Cuxone 250mg IV Injection
Approved)
Evaluation by PEC:

Brand Name Genxone 250mg IV injection
section.
☐ Export sale
submitted 04-2023

The proposed proprietary name / brand name Cuxone 250mg IM Injection
Approved)
Evaluation by PEC:

46. Name, address of Applicant / Marketing M/s Siam Pharmaceuticals.
Authorization Holder 217, Industrial Triangle, Kahuta Road, Islamabad
Islamabad
☐ Export sale
submitted 06-2022
The proposed proprietary name / brand name Sixone 2gm IV Injection
Pharmaceutical ingredient (API) per unit Ceftriaxone (as sodium)……2g

Approved)
For generic drugs (me-too status) Droncef injection by Seraph Pharmaceuticals
Name and address of API manufacturer. Sinopharm Weiqida Pharmaceutical Co. Ltd. First
Medical zone, Economic & technological
development zone, Datong Shanxi China.
Evaluation by PEC:
Applicant firm M/s Amson Vaccines and Pharma Pvt Ltd. Plot No. 154,
Industrial Triangle Kahuta Road Islamabad
Brand Name Cesod 2gm IV injection
Islamabad
☐ Export sale
submitted 03-2023
The proposed proprietary name / brand name CT-X 2gm IV Injection

Approved)
Evaluation by PEC:
Estate, Rawat
Islamabad
☐ Export sale
submitted 05-2022
The proposed proprietary name / brand name Pinecef 1gm IV Injection
Approved)

Evaluation by PEC:
Estate, Rawat
Islamabad
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Pinecef 250mg IV Injection
Proposed Pack size As per SRO
The status in reference regulatory authorities Ceftriaxone 250mg powder for solution for injection
(MHRA Approved)
For generic drugs (me-too status) Droncef injection 250mg by Seraph Pharmaceuticals

Evaluation by PEC:
Applicant firm M/s CCL Pharmaceuticals (Pvt) Ltd. 62-Industrial Estate, Kot
Lakhpat Lahore.
Brand Name Snare 250mg IV injection
Islamabad
☐ Importer
☐ Export sale
The proposed proprietary name / brand name CT-X 250mg IV Injection
(MHRA Approved)

Evaluation by PEC:
Lakhpat Lahore.
Brand Name Snare IV injection
Islamabad
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Unidon 250mg IV Injection
(MHRA Approved)

Evaluation by PEC:
Lakhpat Lahore.
Brand Name Snare 250 IV injection
Islamabad
☐ Export sale
submitted 03-2022
The proposed proprietary name / brand name Unidon 250mg IM Injection
Approved)
Evaluation by PEC:

Applicant firm M/s Siam Pharmaceuticals.,

Plot No. 217, Industrial Triangle, Kahuta Road, Islamabad
Brand Name Sixone 250mg IM injection
Estate, Rawat
Islamabad
☐ Export sale
submitted 05-2022
The proposed proprietary name / brand name Pinecef 250mg IM Injection
Approved)
Evaluation by PEC:


Estate, Rawat
Islamabad
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Pinecef 500mg IV Injection
(MHRA Approved)
Evaluation by PEC:
Industrial Triangle Kahuta Road Islamabad.

Brand Name Cesod 500mg IV injection
Islamabad
☐ Importer
☐ Export sale
The proposed proprietary name / brand name CT-X 500mg IV Injection
(MHRA Approved)
Evaluation by PEC:

Islamabad
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Unidon 500mg IV Injection
(MHRA Approved)
Evaluation by PEC:

Islamabad
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Unidon 500mg IM Injection
(MHRA Approved)
Evaluation by PEC:


Estate, Rawat
Islamabad
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Pinecef 500mg IM Injection
(MHRA Approved)
Evaluation by PEC:


Citicoline
59. Name, address of Applicant / Marketing M/s Winlet Pharmaceuticals.
Authorization Holder 30-km, Lahore Sargodha Road, Lahore
Name, address of Manufacturing site. M/s May & Baker (Pvt) Ltd.
45-km Dina Nath, Multan Road, Lahore
GMP status of the manufacturer DML issued vide letter No.F.1-10/2019-Lic dated
29/04/2022.
Evidence of approval 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)
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Wincit 1gm/4ml Injection
Strength / concentration of drug of Active Each 4ml Ampoule Contains:
Pharmaceutical ingredient (API) per unit Citicoline Sodium as Citicoline ……… 1gm
Pharmaceutical form of applied drug Liquid injection
Pharmacotherapeutic Group of (API) Psychostimulant and nootropic
Reference to Finished product specifications Innovator’s Specification
The status in reference regulatory authorities Approved b AIFA of Italy
For generic drugs (me-too status) Citolin innjection by M/s Global Pharma Reg.
No.030541
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
Evaluation by PEC:
The applied product to be manufactured by M/s May & Baker (Pvt) Ltd. 45-km Dina Nath, Multan Road,
Lahorehave already been approved by Registration Board in its 323 rd meeting based on the data of same
batches of drug product as submitted in the instant case. The details of the already approved product are as
follows:
Applicant firm M/s May & Baker (Pvt) Ltd. 45-km Dina Nath, Multan Road,
Lahore
Manufacturer firm M/s May & Baker (Pvt) Ltd. 45-km Dina Nath, Multan Road,
Lahore

Brand Name C-Coline 1gm/4ml Injection
Cholecalciferol
60. Name, address of Applicant / Marketing M/s Onyx Pharmaceuticals.

Authorization Holder 30-A, Industrial Estate Mansehra
2022.
2022.
The GMP certificate specifies liquid ampoule
(General) section.
☐ Export sale
submitted 11-2022
The proposed proprietary name / brand name Dorvit Ampoule
Strength / concentration of drug of Active Each ampoule Contains:
Pharmaceutical ingredient (API) per unit Cholecalciferol………5mg
Pharmaceutical form of applied drug Sterile clear and colourless oily solution filled in glass
ampoules
Pharmacotherapeutic Group of (API) Vitamin
Reference to Finished product specifications Innovator’s specs
The status in reference regulatory authorities Cholecalciferol Injection (ANSM France Approved)
For generic drugs (me-too status) Novel-D Injection by Danas Pharma (Reg #073183)
Name and address of API manufacturer. Fermenta Biotech Limited. Village Takoli P.O.
Nagwain, Dist Mandi Himachal Pradesh India.

Evaluation by PEC:
Kahuta Road Islamabad. have already been approved by Registration Board in its 323rd meeting based on
Applicant firm M/s Cherwel Pharmaceuticals (Pvt) Ltd. Plot No. 20, Phase 4,
Hattar-Industrial Estate, KPK.
Brand Name Sunray Injection 5mg/mL
2022.
2022.
(General) section.
☐ Export sale
submitted 10-2021
The proposed proprietary name / brand name D-Next Ampoule
ampoules
Evaluation by PEC:

Kahuta Road Islamabad. have already been approved by Registration Board in its 323 rd meeting based on
2022.
2022.
(General) section.
☐ Export sale
submitted 08-2022
The proposed proprietary name / brand name Univit Injection
ampoules
Evaluation by PEC:

Kahuta Road Islamabad. have already been approved by Registration Board in its 323 rd meeting based on
Colistimethate Sodium
63. Name, address of Applicant / Marketing M/s Caliph Pharmaceuticals Pvt Ltd.
Authorization Holder Plot # 17, Special Industrial Zone, Risalpur, KPK,
Pakistan
29/04/2022.
Evidence of approval of manufacturing facility DML issued vide letter No.F.1-10/2019-Lic dated
29/04/2022 declares Dry Powder Vial Section
(General)
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Colistat 150mg Injection
Pharmaceutical ingredient (API) per unit Colistimethate Sodium Eq. to 150mg Colistimethate
Base Activity
Pharmaceutical form of applied drug Sterile white to yellowish fine powder filled in
transparent glass vials.
Pharmacotherapeutic Group of (API) Antibiotic
Reference to Finished product specifications USP
The status in reference regulatory authorities COLOMYCIN 4.5 million International Units (IU)
Injection (MHRA Approved)
Name and address of API manufacturer. M/s Livzon Group Fuzhou Fuxing Pharmaceutical
Co., Ltd., No. 8. Nangang road Jiangyin Industrial
Concentration zone, Fuqing, Fuzhou city, Fujian
province, China.
Evaluation by PEC:

The applied product to be manufactured M/s May & Baker (Pvt) Ltd. 45-km Dina Nath, Multan Road,
Lahore have already been approved by Registration Board in its 324 th meeting based on the data of same
follows:
Lahore
Lahore
Brand Name Colmate 4.5MIU Injection
Pakistan
29/04/2022.
(General)
☐ Export sale
submitted 07-2023
Base Activity
The status in reference regulatory authorities COLOMYCIN 2 million International Units (IU)
For generic drugs (me-too status) Colistimethate injection 2 MIU by Mukhtar
Enterprises
province, China.
Evaluation by PEC:

follows:
Lahore
Lahore
Brand Name Colmate 2MIU Injection
Pakistan
29/04/2022.
(General)
☐ Export sale
submitted 07-2023
Base Activity
Enterprises
province, China.
Evaluation by PEC:
Lahore have already been approved by Registration Board in its 324th meeting based on the data of same
follows:

Lahore
Lahore
29/04/2022.
(General)
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Colet 4.5 MIU Powder for Injection
Base Activity
province, China.
Evaluation by PEC:
follows:
Lahore
Lahore

Brand Name Colmate 4.5MIU Injection
29/04/2022.
(General)
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Colet 2 MIU Powder for Injection
Base Activity
Enterprises
province, China.
Evaluation by PEC:
Lahore have already been approved by Registration Board in its 324th meeting based on the data of same
follows:
Lahore
Lahore

29/04/2022.
(General)
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Colet 1 MIU Powder for Injection
Base Activity
Enterprises
province, China.
Evaluation by PEC:
follows:
Lahore
Lahore
69. Name, address of Applicant / Marketing M/s Genetics Pharmaceuticals Pvt. Ltd.
Authorization Holder 539-A, Sundar Industrial Estate,Raiwind,Lahore

Name, address of Manufacturing site. M/s English Pharmaceuticals Industries. Link Kattar
Bund Road, Thokar Niaz Baig, Multan Road, Lahore
GMP status of the manufacturer English pharmaceuticals: Firm has submitted copy
of GMP certificate dated 17-08-2022. The certificate
was issued based on the inspection dated 14-07-2022.
Evidence of approval of manufacturing facility Firm has submitted copy of GMP certificate dated 17-
08-2022. The certificate was issued based on the
inspection dated 14-07-2022. The certificate specifies
dry powder injection general section..
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Choligene 150mg Injection
Base Activity
Name and address of API manufacturer. M/s Hebei Shengxue Dacheng Pharmaceutical Co Ltd.
No. 50 Shengxue Road Launcheng District
Shijiazhuang
Evaluation by PEC:
The applied product to be manufactured by M/s English Pharmaceuticals Industries. Link Kattar Bund
Road, Thokar Niaz Baig, Multan Road, Lahore have already been approved by Registration Board in its
of the already approved product are as follows:
Manufacturer firm M/s English Pharmaceuticals Industries. Link Kattar Bund
Road, Thokar Niaz Baig, Multan Road, Lahore
Brand Name Colizone 4.5MIU Injection

☐ Export sale
submitted 07-2023
Base Activity
Enterprises
Shijiazhuang
Evaluation by PEC:
Brand Name Colizone 2MIU Injection

☐ Export sale
submitted 07-2023
Base Activity
Enterprises
Shijiazhuang
Evaluation by PEC:
296th meeting based on the data of same batches of drug product as submitted in the instant case. The details
Applicant firm M/s Macter International Limited. F-216, SITE, Karachi.

Brand Name Colmit 1MIU Injection
72. Name, address of Applicant / Marketing M/s Bio Mark Pharmaceuticals.
Authorization Holder Plot No. 527, Sundar Industrial Estate,Lahore

☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Cholisti 150mg Powder for Injection
Base Activity
Shijiazhuang
Evaluation by PEC:

☐ Export sale
submitted 07-2023
Base Activity
Enterprises
Shijiazhuang
Evaluation by PEC:
☐ Export sale

submitted 07-2023
Base Activity
Enterprises
Shijiazhuang
Evaluation by PEC:

75. Name, address of Applicant / Marketing M/s Kanel Pharma.
Authorization Holder Plot # 6, St # SS-3, National Industrial Zone,
Rawat, Islamabad
☐ Export sale

submitted 05-2022
The proposed proprietary name / brand name Colistime 1 MIU Injection
Pharmaceutical ingredient (API) per unit Colistimethate Sodium…1MIU
Enterprises
Shijiazhuang
Evaluation by PEC:

76. Name, address of Applicant / Marketing M/s Swiss Pharmaceuticals Pvt Ltd.
Authorization Holder A-159, S.I.T.E Super Highway, Karachi, Pakistan
Name, address of Manufacturing site. M/s Biogen Life Sciences.
8-Km, Chakbeli Road, Rawat, Rawalpindi, Pakistan
Injection section (General).
☐ Export sale
submitted 10-2022
The proposed proprietary name / brand name Hy-Colis 1 MIU Injection
Colistimethate Sodium Eq. to 80mg of Sterile

Pharmaceutical ingredient (API) per unit Colistimethate Sodium…1MIU
Enterprises
Name and address of API manufacturer. Hebei Shengxue Dacheng Co. Ltd. No. 50, Shengxue
Road No. 17 Fuqiangxi Road, Luacheng County,
Hebei Province P.R China.
Evaluation by PEC:
The applied product to be manufactured by M/s Biogen Life Scie nces8-Km, Chakbeli Road, Rawat,

Rawalpindi
Rawalpindi
Brand Name Listim 1MIU Injection
77. Name, address of Applicant / Marketing M/s Seraph Pharmaceuticals.
Authorization Holder Plot No. 210, Industrial Triangle, Kahuta Road,
Islamabad
☐ Export sale
submitted 05-2022
The proposed proprietary name / brand name Coliser 1 MIU IV Injection
Strength / concentration of drug of Active Each vial Contains:
Pharmaceutical ingredient (API) per unit Colistimethate sodium………1 MIU

Enterprises
Evaluation by PEC:

Rawalpindi
Rawalpindi
78. Name, address of Applicant / Marketing M/s Seraph Pharmaceuticals.
Authorization Holder Plot No. 210, Industrial Triangle, Kahuta Road,
Islamabad
☐ Export sale
submitted 05-2022
The proposed proprietary name / brand name Coliser 2 MIU IV Injection
Pharmaceutical ingredient (API) per unit Colistimethate sodium………2 MIU

Enterprises (Reg #094757)
Evaluation by PEC:

Rawalpindi
Rawalpindi
79. Name, address of Applicant / Marketing M/s Wimits Pharmaceuticals (Pvt.) Ltd.
Authorization Holder Plot No. 129, Sundar Industrial Estate, Raiwind
Road, Lahore
☐ Export sale
Dy. No. and date of submission & Details of fee Dy.No. 17919 dated 14-07-2023 Rs.75,000/-
submitted
The proposed proprietary name / brand name Coliswim 150mg Powder for Injection
Base Activity

Shijiazhuang
Evaluation by PEC:
Road, Lahore
☐ Export sale
Dy. No. and date of submission & Details of fee Dy.No 17918 dated 14-07-2023 Rs.75,000/-
submitted
The proposed proprietary name / brand name Coliswim 68mg Injection
Base Activity
Enterprises

Shijiazhuang
Evaluation by PEC:
Road, Lahore
☐ Export sale
Dy. No. and date of submission & Details of fee Dy.No. 17917 dated 14-07-2023 Rs.75,000/-
submitted
The proposed proprietary name / brand name Coliswim 34mg Injection
Base Activity
Enterprises

Shijiazhuang
Evaluation by PEC:

Dapagliflozin

Hattar, KPK
Name, address of Manufacturing site. M/s Welmark Pharmaceuticals Plot #122 Phase 5,
Block B, Industrial Hatta
GMP status of the manufacturer GMP certificate issued on 23.11.2021 by DRAP
peshawer
Evidence of approval of manufacturing facility GMP certificate issued on 23.11.2021 by DRAP
peshawer declares tablet geenra section availability
submitted 07-2023
The proposed proprietary name / brand name Dapag 5mg Tablet
Pharmaceutical ingredient (API) per unit Dapagliflozin as Propanediol Monohydrate…5mg
Pharmaceutical form of applied drug Film coated tablets.
Pharmacotherapeutic Group of (API) Anti-Diabetic
Reference to Finished product specifications Product Complies Innovator’s Specs
The status in reference regulatory authorities Forxiga Tablet , USFDA Approved.
For generic drugs (me-too status) Dapa 5mg Tablet Hilton Pharma, Karachi
Reg. No. 089367
Name and address of API manufacturer. Fuxin Long Rui Pharmaceutical CO. Ltd Address：
Fluoride Industrial Park,Fumeng County(Yi
MaTu),FuxinCity,Liaoning Province-123000,China
Evaluation by PEC:

The applied product to be manufactured by M/s Welmark Pharmaceuticals Plot #122 Phase 5, Block B,
Industrial Hatta have already been approved by Registration Board in its 326 th meeting based on the data
of same batches of drug product as submitted in the instant case. The details of the already approved product
are as follows:
Applicant firm M/s Welmark Pharmaceuticals Plot #122 Phase 5, Block B,

Industrial Hatta
Manufacturer firm M/s Welmark Pharmaceuticals Plot #122 Phase 5, Block B,
Industrial Hatta
Brand Name DAPAZIN 5MG TABLET
Hattar, Pakistan
peshawer
submitted 07-2023
The proposed proprietary name / brand name Dappa 5mg Tablet
Reg. No. 089367
Evaluation by PEC:
are as follows:

Industrial Hatta
Industrial Hatta

peshawer
submitted 07-2023
The proposed proprietary name / brand name Deffa 5mg Tablet
Reg. No. 089367
Evaluation by PEC:
are as follows:

Industrial Hatta
Industrial Hatta
85. Name, address of Applicant / Marketing M/s Wezen Pharmaceuticals.
Authorization Holder Plot No. 23 & 24, Phase S-I, Industrial Estate,
Rawat
peshawer
submitted 07-2023
The proposed proprietary name / brand name Daglo 5mg Tablet

Reg. No. 089367
Evaluation by PEC:
Industrial Hatta have already been approved by Registration Board in its 326th meeting based on the data
are as follows:

Industrial Hatta
Industrial Hatta
86. Name, address of Applicant / Marketing M/s Welwink Pharmaceuticals.
Authorization Holder Factory G.T. Road, Industrial Estate, Gujranwala
Cantt.
peshawer
Dy. No. and date of submission & Details of fee Dy.No 17823 dated 14-07-2023 Rs.75,000/
submitted
The proposed proprietary name / brand name Dapego 5mg Tablet
Reg. No. 089367

Evaluation by PEC:
are as follows:

Industrial Hatta
Industrial Hatta
87. Name, address of Applicant / Marketing M/s Wallace Pharma Evolution.
Authorization Holder Kala Wala Stop, 20 Km, Lahore Jaranwala Road,
Lahore
peshawer
submitted 07-2023
The proposed proprietary name / brand name Dypa 5mg Tablet
Reg. No. 089367
Evaluation by PEC:

are as follows:

Industrial Hatta
Industrial Hatta
Dapagliflozin/Metformin
88. Name, address of Applicant / Marketing M/s Indus Pharma (Pvt.) Ltd.
Authorization Holder Plot No. 26,27 & 63-67, Sector 27, Korangi
Industrial Area, Karachi
Name, address of Manufacturing site. M/s CCL Pharmaceuticals Pvt Ltd. 62 Industrial
Estate,Kot Lakhpat,Lahore
CCL Pharmaceuticals issued on the basis of inspection
dated 30-04-2019.
Evidence of approval of manufacturing facility Firm has submitted copy of letter of renewal of Drug
Manufacturing License (No. 000052) dated 08-06-
2021 specifying Tablet (General) section.
☐ Export sale
submitted 06-2023
The proposed proprietary name / brand name Dapazin Met XR 10/1000 mg Tablet
Strength / concentration of drug of Active Each Film Coated Bi-Layered Tablet Contains:
Pharmaceutical ingredient (API) per unit Dapagliflozin Paropandediol Monohydrate Eq. to
Dapagliflozin…10mg
Metformin HCl…1000mg
Pharmaceutical form of applied drug Film coated double layer tablet
Pharmacotherapeutic Group of (API) Combination of oral blood glucose lowering drugs
Reference to Finished product specifications As per innovator’s product
The status in reference regulatory authorities USFDA Approved
For generic drugs (me-too status) Xiga-Met XR Tablet of CCL
Name and address of API manufacturer. Dapagliflozin: M/s Fuxin Long Rui Pharmaceutical
Co., Ltd., Flouride Industrial park, Fuxin City,
Liaoning province, China.
Metformin HCl: M/s Wanbury Limited., Doctor’s
Organic Chemical Division K Illindalaparru 534217

Iragavaram Mandal West Godavari District Andhra
Pradesh, India.
Evaluation by PEC:
The applied product to be manufactured by M/s CCL Pharmaceuticals (Pvt) Ltd 62-industrial Estate, Kot
Lakhpat, Lahore have already been approved by Registration Board in its 324 th meeting based on the data
are as follows:
Applicant firm M/s Dynatis Pakistan (Pvt.) Ltd. Plot No. 710, Sunder
Manufacturer firm M/s CCL Pharmaceuticals Pvt Ltd. 62 Industrial
Brand Name DAPAZIN MET XR 10mg/1000mg Tablet
dated 30-04-2019.
☐ Export sale
submitted 06-2023
Dapagliflozin…5mg

Pradesh, India.
Evaluation by PEC:
Lakhpat, Lahore have already been approved by Registration Board in its 324th meeting based on the data
are as follows:
dated 30-04-2019.
☐ Export sale
submitted 06-2023
Dapagliflozin…5mg

Pradesh, India.
Evaluation by PEC:
Lakhpat, Lahore have already been approved by Registration Board in its 324th meeting based on the data
are as follows:
Drotaverine HCl
29/04/2022.
Evidence of approval 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)
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Tavar 40mg/2ml Injection
Strength / concentration of drug of Active Each 2ml Ampoule Contains:
Pharmaceutical ingredient (API) per unit Drotaverine Hcl Eq. to Drotaverine…40mg
Pharmaceutical form of applied drug Solution for injection
Pharmacotherapeutic Group of (API) Antispasmodic, Anticholinergic
The status in reference regulatory authorities Approved in 3 European countries (Hungary,

Romania, Bulgaria)
For generic drugs (me-too status) No-spa 40mg/2ml by M/s Snofi pharma
Name and address of API manufacturer. M/s R.A Chem Pharma, Ltd India.
Evaluation by PEC:
follows:
Lahore
Lahore
Brand Name Doviene 40mg/2ml injection
Empagliflozin
Lahore
peshawer
submitted 07-2023
The proposed proprietary name / brand name Emzaa 25mg Tablet
Pharmaceutical ingredient (API) per unit Empagliflozin…5mg
The status in reference regulatory authorities USFDA Approved.
For generic drugs (me-too status) Erli tablet of M/s Pharm Evo
Evaluation by PEC:

Industrial Hatta have already been approved by Registration Board in its 322nd meeting based on the data
are as follows:

Industrial Hatta
Industrial Hatta
Brand Name EMPAZIN 5MG TABLET
Empagliflozin/Metformin HCl
Name, address of Manufacturing site. M/s Dynatis Pakistan Pvt Ltd.
Plot No.710, Sundar Industrial Estate, Raiwind Road,
Lahore
GMP status of the manufacturer Copy of GMP certificate No. 29/2021-DRAP(FID-
2065251-174) issued on the basis of inspection
conducted on 26/03/2021.
Evidence of approval of manufacturing facility Copy of GMP certificate No. 29/2021-DRAP(FID-
conducted on 26/03/2021 declares availability of
Tablet general section.
☐ Export sale
submitted 11-2022
The proposed proprietary name / brand name Glifo-Met 12.5/500 mg Tablet
Strength / concentration of drug of Active Each film coated tablet contains:
Pharmaceutical ingredient (API) per unit Empagliflozin…………….12.5mg
Metformin HCl…………...500mg
Pharmaceutical form of applied drug Immediate release Film coated tablet
Pharmacotherapeutic Group of (API) Drugs used in diabetics (Combination of oral
blood glucose lowering drugs)
The status in reference regulatory authorities Synjardy (12.5/500mg) tablet, USFDA
Approved.
For generic drugs (me-too status) Empagen 12.5/500 tablet by M/s Ferozsons.

Name and address of API manufacturer. Empagliflozin:
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.
Evaluation by PEC:
The applied product to be manufactured by M/s Dynatis Pakistan (Pvt.) Ltd. Plot No. 710, Sunder Industrial
Estate, Lahore, Multan Road, Lahore have already been approved by Registration Board in its 324 th
meeting based on the data of same batches of drug product as submitted in the instant case. The details of
the already approved product are as follows:
Manufacturer firm M/s Dynatis Pakistan (Pvt.) Ltd. Plot No. 710, Sunder
Brand Name Gliflo-Met 12.5/500mg tablet
Lahore
☐ Export sale
submitted 11-2022
The proposed proprietary name / brand name Glifo-Met 12.5/1000 mg Tablet
Pharmaceutical ingredient (API) per unit Empagliflozin…………….12.5mg

The status in reference regulatory authorities Synjardy (12.5/1000mg) tablet, USFDA
Approved.
For generic drugs (me-too status) Empagen 12.5/1000 tablet by M/s Ferozsons.
Metformin HCl:
Province, China.
Evaluation by PEC:
Brand Name Gliflo-Met 12.5/1000mg tablet
Lahore
☐ Export sale
submitted 11-2022
The proposed proprietary name / brand name Glifo-Met 5/1000 mg Tablet

Pharmaceutical ingredient (API) per unit Empagliflozin…………….5mg
The status in reference regulatory authorities Synjardy (5/1000mg) tablet, USFDA Approved.
For generic drugs (me-too status) Empagen 5/1000 tablet by M/s Ferozsons.
Metformin HCl:
Province, China.
Evaluation by PEC:
Brand Name Gliflo-Met 5/1000mg tablet
Lahore
☐ Export sale

submitted 11-2022
The proposed proprietary name / brand name Glifo-Met 5/500 mg Tablet
Pharmaceutical ingredient (API) per unit Empagliflozin…………….5mg
The status in reference regulatory authorities Synjardy (5/500mg) tablet, USFDA Approved.
For generic drugs (me-too status) Empagen 5/500 tablet by M/s Ferozsons.
Metformin HCl:
Province, China.
Evaluation by PEC:
Estate, Lahore, Multan Road, Lahore have already been approved by Registration Board in its 322 nd
Brand Name Gliflo-Met 5/500mg tablet
Esomeprazole Sodium
97. Name, address of Applicant / Marketing M/s Aptcure Pvt Ltd
Authorization Holder 8- Pharma City, 30 km Multan Road, Lahore
Name, address of Manufacturing site. M/s Variant pharmaceuticals (Pvt) Ltd, Plot No. 5, M-
2, Pharmazone, 26 Km, Lahore Sharikpur Road,
Sheikhupura.
GMP status of the manufacturer The firm was granted New DML (000914) on the
recommendations of CLB in its 273rd meeting held on
15th January, 2020
Evidence of approval of manufacturing facility The firm has provided Dry powder injection section
(pre-lyophilized) vial section (General) vide letter No.
F. 1-1/2016-Lic of licensing division.

☐ Export sale
submitted 08-2022
The proposed proprietary name / brand name Nexapt 40mg IV Injection
Pharmaceutical ingredient (API) per unit Esomeprazole as sodium ------- 40 mg
Pharmaceutical form of applied drug Powder for injection/infusion (Pre-Lyophilized)
Pharmacotherapeutic Group of (API) Proton Pump inhibitor
For generic drugs (me-too status) Nexium 40mg IV powder for solution of M/s GETZ
Pharma
Name and address of API manufacturer. Sterile India Pvt Ltd. Plot No. 100, Sec-56 Phase-4,
Kundli Sonipat (Haryana) India.
Evaluation by PEC:
The applied product to be manufactured by M/s Variant pharmaceuticals (Pvt) Ltd, Plot No. 5, M-2,
Pharmazone, 26 Km, Lahore Sharikpur Road, Sheikhupura have already been approved by Registration
Applicant firm M/s Variant pharmaceuticals (Pvt) Ltd, Plot No. 5, M-2,
Pharmazone, 26 Km, Lahore Sharikpur Road, Sheikhupura.
Manufacturer firm M/s Variant pharmaceuticals (Pvt) Ltd, Plot No. 5, M-2,
Brand Name Esovar 40mg Injection
98. Name, address of Applicant / Marketing M/s Bajwa Pharmaceuticals (Pvt) Ltd.
Authorization Holder 36-Km, GT Road Khori Murredke,Sheikhupura
Sheikhupura.
15th January, 2020
☐ Export sale

submitted 02-2023
The proposed proprietary name / brand name Esolip 40mg IV Injection
Pharma
Evaluation by PEC:
99. Name, address of Applicant / Marketing M/s Sarco Chemical Industries.
Authorization Holder 17-Km, Peerwala Morr, Qader Pur Ban, Khanewal
Road, District Multan
Name, address of Manufacturing site. M/s English Pharmaceuticals Industries.
Link Kattar Bund Road, Thokar Niaz Baig, Multan
Road, Lahore
GMP status of the manufacturer M/s English Pharmaceuticals: Certificate of GMP
Issued to English Pharmaceuticals on 16-01-2018.
Evidence of approval of manufacturing facility M/s English Pharmaceuticals: The firm has
provided Dry powder injection vials (General)
approval.
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Sar-Esom 40mg Powder for Injection

The status in reference regulatory authorities Approved by MHRA of UK
For generic drugs (me-too status) Nexium 40 mg IV injection
By M/S Getz Pharma
Name and address of API manufacturer. M/s Sterile India Pvt. Ltd Plot No.100, 118-G,
Sector-56,
Phase-IV, HSIIDC, Kundli District Sonepat,
Haryana,
India
Evaluation by PEC:
The applied product to be manufactured by M/s English Pharmaceuticals Industries Link Kattar Bund
Applicant firm M/s Pharmedic laboratories., 15-16 Km, Multan Road Lahore.
Manufacturer firm M/s English Pharmaceuticals.

Indus Link Kattar Band Road, Thokar Niaz Baig, Multan Road,
Lahore
Brand Name Epsol 40mg Injection
☐ Export sale
submitted 09-2022
The proposed proprietary name / brand name Eso-Rose 40mg Injection

By M/S Getz Pharma
Name and address of API manufacturer. Vision Pharmaceuticals (Pvt) Ltd. Plot No. 22-23,
Industrial Triangle, Kahuta Road Islamabad.
Evaluation by PEC:

Rawalpindi
Rawalpindi
Brand Name Esogen 40mg Injection
Name, address of Manufacturing site. M/s Bio Labs Pvt Ltd.
Plot # 145, Industrial Triangle, Kahuta Road,
Islamabad
2022.
2022.
The GMP certificate specifies Lyophilized Injectable
section
☐ Export sale
submitted 09-2022
The proposed proprietary name / brand name Esonext 40mg Injection
Pharmaceutical ingredient (API) per unit Esomeprazole as sodium………………40mg
Pharmaceutical form of applied drug Almost white colored lyophilized, hygroscopic
powder filled in glass vial.
Pharmacotherapeutic Group of (API) Proton pump inhibitor

The status in reference regulatory authorities Nexium IV 40mg Injection of M/s AstraZeneca
(USFDA approved)
For generic drugs (me-too status) Esomine 40mg Injection Lawari International (R#
069703)
Name and address of API manufacturer. M/s. Sterile India Pvt. Ltd. Plot No. 100, Sec-56 Phase
-4, Kundli Sonipat (Haryana) India
Evaluation by PEC:
The applied product to be manufactured by M/s Bio Labs Pvt Ltd. Plot # 145, Industrial Triangle, Kahuta
Road, Islamabad have already been approved by Registration Board in its 3th17 meeting based on the data
are as follows:
Applicant firm M/s Cherwel Pharmaceuticals (Pvt) Ltd. plot # 20, Phase 4,
Hattar Industrial Estate, Hattar KPK from M/s Bio-Labs (Pvt)
Ltd
Manufacturer firm M/s Bio Labs Pvt Ltd.
Plot # 145, Industrial Triangle, Kahuta Road, Islamabad
Brand Name Esocare 40mg Injection
 The composition shall mention “Each Lyophilized Vial contains” since manufacturer had approval
of applied formulation in “Lyophilized vial (Injectable) general section.
102. Name, address of Applicant / Marketing M/s Rakaposhi Pharmaceuticals Pvt Ltd.
Authorization Holder 97-K, Industrial Estate, Hayatabad, Peshawar,
Pakistan
Name, address of Manufacturing site. M/s Bio Labs Pvt Ltd. Plot # 145, Industrial Triangle,
2022.
2022.
section
☐ Export sale
submitted 04-2022
The proposed proprietary name / brand name Esorok 40mg Injection
(USFDA approved)
069703)
Evaluation by PEC:
Road, Islamabad have already been approved by Registration Board in its 3 th17 meeting based on the data
are as follows:
Ltd
103. Name, address of Applicant / Marketing M/s Linear Pharma
Authorization Holder Plot # 18, Street # S-4, National Industrial Zone,
RCCI Rawat, islamabad
Islamabad
2022.
2022.
section
☐ Export sale
submitted 03-2022
The proposed proprietary name / brand name So-Zar 40mg Injection
(USFDA approved)
069703)
Evaluation by PEC:
Road, Islamabad have already been approved by Registration Board in its 3th17 meeting based on the data
are as follows:
Ltd
Sheikhupura.
15th January, 2020
☐ Export sale
submitted 02-2022
The proposed proprietary name / brand name Eseft 40mg IV Injection
Pharma
Evaluation by PEC:
105. Name, address of Applicant / Marketing M/s Hoover Pharmaceuticals (Pvt) Ltd.
Authorization Holder Plot No. 16, Zain Park, Industrial Area, Saggian
Bypass Road, Lahore
Sheikhupura.
15th January, 2020
☐ Export sale
submitted 12-2022
The proposed proprietary name / brand name Essopel 40mg IV Injection
Pharma
Evaluation by PEC:
106. Name, address of Applicant / Marketing M/s Biogen Pharma.
Authorization Holder 8-Km, Chakbeli Road, Rawat, Rawalpindi,
Pakistan
☐ Export sale
submitted 05-2022
The proposed proprietary name / brand name Bioom 40mg Injection
By M/S Getz Pharma
Evaluation by PEC:

Rawalpindi
Rawalpindi
107. Name, address of Applicant / Marketing M/s Shawan Pharmaceuticals.
Authorization Holder Plot No. 37, Road: Ns-01, National Industrial Zone,
Rawat, Rawalpindi
☐ Export sale
submitted 05-2022
The proposed proprietary name / brand name Esoa 40mg Injection
By M/S Getz Pharma
Evaluation by PEC:

Rawalpindi
Rawalpindi
108. Name, address of Applicant / Marketing M/s Valor Pharmaceuticals.
Authorization Holder 124/A Industrial Triangle, Kahuta Road
Islamabad
☐ Export sale
submitted 05-2022
The proposed proprietary name / brand name Oxilant 40mg Injection
By M/S Getz Pharma
Evaluation by PEC:

Rawalpindi
Rawalpindi
Name, address of Applicant / Marketing M/s Well & Well Pharma Pvt Ltd.
109. Authorization Holder Plot 7, Street S-8, RCCI, National Industrial Zone,
Rawat, Islamabad
Name, address of Manufacturing site. M/s Vision Pharmaceuticals.
Plot # 22,23, Industrial Triangle, Kahuta Road,
Islamabad
GMP status of the manufacturer GMP certificate issued based upon inspection
conducted in 26-01-2018.
Evidence of approval of manufacturing facility GMP certificate issued based upon inspection
conducted in 26-01-2018 declares Dry powder
injection general section
☐ Export sale
submitted 11-2022
The proposed proprietary name / brand name Emple 40mg Injection
Strength / concentration of drug of Active Each vial of powder for solution for infusion contains
Pharmaceutical ingredient (API) per unit Esomeprazole sodium, equivalent to 40 mg
Esomeprazole.
The status in reference regulatory authorities Esomeprazole 40mg Powder for Solution for Infusion
(MHRA)
By M/S Getz Pharma
Name and address of API manufacturer. M/s Vision Pharmaceuticals.
Islamabad
Evaluation by PEC:
The applied product to be manufactured by M/s Vision Pharmaceuticals Plot # 22,23, Industrial Triangle,
Kahuta Road, Islamabad have already been approved by Registration Board in its 312 th meeting based on
Applicant firm M/s Nagarsons Pharmaceuticals (Pvt) Ltd., Plot No. 34, St. No.
NS-2, National Industrial Zone, Rawat, Islamabad
Manufacturer firm M/s Vision Pharmaceuticals Plot # 22,23, Industrial Triangle,
Brand Name Esonag 40mg IV Injection
110. Name, address of Applicant / Marketing M/s Pharma Lord (Pvt) Ltd.
Authorization Holder 12 KM, Lahore Raod, Layyah, Punjab
Islamabad
☐ Export sale
submitted 06-2022
The proposed proprietary name / brand name Esolor 40mg Injection
Pharmaceutical ingredient (API) per unit Esomeprazole sodium, equivalent to 40 mg
Esomeprazole.
The status in reference regulatory authorities Esomeprazole 40mg Powder for Solution for Infusion
(MHRA)
By M/S Getz Pharma
Islamabad
Evaluation by PEC:
Applicant firm M/s Nagarsons Pharmaceuticals (Pvt) Ltd., Plot No. 34, St. No.
NS-2, National Industrial Zone, Rawat, Islamabad
Brand Name Esonag 40mg IV Injection
Road, Lahore
Road, Lahore
approval.
☐ Export sale
submitted
The proposed proprietary name / brand name Aldis 40mg Powder for Injection
By M/S Getz Pharma
Name and address of API manufacturer. M/s Sterile India Pvt. Ltd Plot No.100, 118-G,
Sector-56,
Phase-IV, HSIIDC, Kundli District Sonepat,
Haryana,
India
Evaluation by PEC:

Lahore
Brand Name Epsol 40mg Injection
Esomeprazole/Naproxen
Hattar, KPK
Hattar
approved.
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Ezonpp 375/20 mg Tablet
Strength / concentration of drug of Active Each delayed release tablet contains:
Pharmaceutical ingredient (API) per unit Esomeprazole (as magnesium trihydrate) as IR ….….
20mg
Naproxen as enteric coated core …………………….
375mg
Pharmaceutical form of applied drug Tablet
Pharmacotherapeutic Group of (API) Esomeprazole: Proton Pump Inhibitors
Naproxen: Anti-inflammatory and antirheumatic
products, non-steroids. Propionic acid derivatives.
The status in reference regulatory authorities Vimovo delayed release tablet 20/375mg
USFDA
For generic drugs (me-too status) Glomov 20/375mg tablet by M/s Global
Pharmaceutical (Pakistan) Reg No 109338
Name and address of API manufacturer. Esomeprazole: Metrochem API Private Ltd. India flat
No 302, Bhanu Enclave , Sunder 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
Evaluation by PEC:
are as follows:

Kpk Pakistan.
Kpk Pakistan.
Brand Name Esonyp 20/375mg DR Tablet
Rawat
Hattar
approved.
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Eznop 500/20 mg DR Tablet
20mg
500mg
USFDA
Hyderabad , India.
Evaluation by PEC:
are as follows:

Kpk Pakistan.
Kpk Pakistan.
Rawat
Hattar
approved.
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Esonap 20/375 mg Tablet
20mg
375mg
USFDA
Hyderabad , India.
Evaluation by PEC:
are as follows:

Kpk Pakistan.
Kpk Pakistan.
Cantt.
Hattar
approved.
☐ Export sale
Dy. No. and date of submission & Details of fee Dy.No 17830 dated 14-07-2023 Rs.75,000/
submitted
20mg
500mg
USFDA
Hyderabad , India.
Evaluation by PEC:
are as follows:

Kpk Pakistan.
Kpk Pakistan.
Cantt.
Hattar
approved.
☐ Export sale
submitted
20mg
375mg
USFDA
Hyderabad , India.
Evaluation by PEC:
are as follows:

Kpk Pakistan.
Kpk Pakistan.
Hattar, Pakistan
Hattar
approved.
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Esonepp 20/500 mg Tablet
20mg
500mg
USFDA
Hyderabad , India.
Evaluation by PEC:
are as follows:

Kpk Pakistan.
Kpk Pakistan.
Hattar, Pakistan
Hattar
approved.
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Esonepp 20/375 mg Tablet
20mg
375mg
USFDA
Hyderabad , India.
Evaluation by PEC:
are as follows:

Kpk Pakistan.
Kpk Pakistan.
Lahore
Hattar
approved.
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Zonepp 20/500 mg Tablet
20mg
500mg
USFDA
Hyderabad , India.
Evaluation by PEC:
are as follows:

Kpk Pakistan.
Kpk Pakistan.
Lahore
Hattar
approved.
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Zonepp 20/375 mg Tablet
20mg
375mg
USFDA
Hyderabad , India.
Evaluation by PEC:
are as follows:

Kpk Pakistan.
Kpk Pakistan.
121. Name, address of Applicant / Marketing M/s Welmark Pharmaceuticals.
Authorization Holder Plot #122 Phase 5, Block B, Industrial Hatta
Hattar
approved.
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Esopenn DR 20/500 mg Tablet
20mg
500mg
USFDA
Hyderabad , India.
Evaluation by PEC:
are as follows:

Kpk Pakistan.
Kpk Pakistan.
Hattar
approved.
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Esopenn DR 20/375 mg Tablet
20mg
375mg
USFDA
Hyderabad , India.
Evaluation by PEC:
are as follows:

Kpk Pakistan.
Kpk Pakistan.
123. Name, address of Applicant / Marketing M/s Carer Pharmaceutical Industries.
Authorization Holder Plot No. 27 Main Road, Rawat Industrial Estate,
Rawat, Pakistan
Hattar
approved.
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Esoncar DR 20/500 mg Table
20mg
500mg
USFDA
Hyderabad , India.
Evaluation by PEC:
are as follows:

Kpk Pakistan.
Kpk Pakistan.
Rawat, Pakistan
Hattar
approved.
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Esoncar DR 20/375 mg Table
20mg
375mg
USFDA
Hyderabad , India.
Evaluation by PEC:
are as follows:

Kpk Pakistan.
Kpk Pakistan.
125. Name, address of Applicant / Marketing M/s Nicholas Pharmaceuticals.
Authorization Holder Plot # 34, St. # SS-02, National Industrial Zone,
Rawat, Islamabad
Hattar
approved.
☐ Export sale
submitted 10-2022
The proposed proprietary name / brand name Enrox-E 20/500 mg Tablet
Strength / concentration of drug of Active Each modified release tablet contains:
20mg
500mg
USFDA
Hyderabad , India.
Evaluation by PEC:
are as follows:

Kpk Pakistan.
Kpk Pakistan.
Rawat, Islamabad
Hattar
approved.
☐ Export sale
submitted 10-2022
The proposed proprietary name / brand name Enrox-E 20/375 mg Tablet
20mg
375mg
USFDA
Hyderabad , India.
Evaluation by PEC:
are as follows:

Kpk Pakistan.
Kpk Pakistan.
Hattar
approved.
☐ Export sale
submitted 10-2022
The proposed proprietary name / brand name NapoEs 500/20 mg Tablet
20mg
500mg
USFDA
Hyderabad , India.
Evaluation by PEC:
are as follows:

Kpk Pakistan.
Kpk Pakistan.
Hattar
approved.
☐ Export sale
submitted 10-2022
The proposed proprietary name / brand name NapoEs 375/20 mg Tablet
20mg
375mg
USFDA
Hyderabad , India.
Evaluation by PEC:
are as follows:

Kpk Pakistan.
Kpk Pakistan.
Hydrocortisone Sodium Succinate

Authorization Holder Khewat 13/13, Khatooni No. 57/66, Mouza
Mirpur Kehna, Tehsil Sharakpur, District
Sheikhupura
☐ Importer
GMP status of the manufacturer Firm has been granted new license (DML No.
000911) by way of formulation dated 13-02-2020.
dated 14-02-2020 which specifies Hydrocortisone
injection section.
☐ Export sale
The proposed proprietary name / brand name Icurt 500mg injection
Pharmaceutical ingredient (API) per unit Hydrocortisone Sodium Succinate equivalent to
hydrocortisone…… 500 mg
Pharmaceutical form of applied drug White to off White color, Lyophilized, Sterile
Powder filled in Glass Vial as 1’s Injection with 2mL
Water for Injection further packed in Card board Unit
Carton along with Leaflet.
Pharmacotherapeutic Group of (API) Corticosteroid, Glucocorticosteroid
For generic drugs (me-too status) Cortizone injection by Global pharma
Name and address of API manufacturer. Symbiotec Pharmalab Private Limited Plot no.5, 6, 7
& 8, Special Economic Zone, Phase-II, Pharma
Zone, Pithampur, Dist. Dhar-454774, (M.P.), India
Evaluation by PEC:
Rawalpindi, Pakistan has already been approved by Registration Board in its 307 th meeting based on
the data of same batches of drug product as submitted in the instant case. The details of the already

Rawalpindi
Rawalpindi
Brand Name BIOCORT 500 mg Injection
Decision: The Board noted the information and decided to consider the application on its turn as
per Que or as per the direction of DRAP Authority, which ever is earlier.
Sheikhupura
☐ Importer
injection section.
☐ Export sale
Powder filled in Glass Vial as 1’s Injection
Evaluation by PEC:

Rawalpindi
Rawalpindi
Sheikhupura
☐ Importer
injection section.
☐ Export sale
Evaluation by PEC:

Rawalpindi
Rawalpindi
132. Name, address of Applicant / Marketing M/s Akhai Pharmaceuticals Pvt Ltd.
Authorization Holder Plot # A-248 & A-256 to A-259, H.I.T.E. Lasbela
Balochistan, Pakistan
☐ Importer
injection section.
☐ Export sale
The proposed proprietary name / brand name Hydrocortisone 500mg IV Injection
Powder filled in Glass Vial as 1’s Injection with 2mL
Water for Injection further packed in Card board Unit
Carton along with Leaflet.
Evaluation by PEC:
Rawalpindi, Pakistan has already been approved by Registration Board in its 307th meeting based on

Rawalpindi
Rawalpindi
☐ Importer
injection section.
☐ Export sale
The proposed proprietary name / brand name Hydrocortisone 250mg IV Injection
Evaluation by PEC:

Rawalpindi
Rawalpindi
Ibuprofen
134. Name, address of Applicant / Marketing M/s Global Pharmaceuticals Pvt Ltd
Authorization Holder Plot # 204-205, Industrial Triangle, Kahuta Road,
Islamabad
Islamabad
GMP status of the manufacturer GMP Certificate issued on the basis of GMP
inspection conducted on 11-02-2019
Evidence of approval of manufacturing facility GMP Certificate issued on the basis of GMP
inspection conducted on 11-02-2019, declares
availability of Liquid injectable vial & ampoule
section.
☐ Export sale
submitted 12-2022
The proposed proprietary name / brand name Calador 400mg/100ml IV Infusion
Strength / concentration of drug of Active Each 100ml contains:
Pharmaceutical ingredient (API) per unit Ibuprofen.............400mg
Pharmaceutical form of applied drug Solution for IV Infusion
Pharmacotherapeutic Group of (API) NSAID
Reference to Finished product specifications Innovator’s Specificatons
The status in reference regulatory authorities Ibuprofen 400mgl100ml Solution of Infusion by
B.Braun Melsungen AG-Germany approved by
MHRA
For generic drugs (me-too status) Inbufin 400mg/100ml Infusion by Searl IV Solutions
(R#094023)
Name and address of API manufacturer. Hubei Granules-Biocause Pharmaceutical Co., Ltd, 22
Yangwan Road, Jingmen City, Hubei Province
448000, China.
Evaluation by PEC:
Applicant firm M/s Vision Pharmaceuticals.

Plot # 22,23, Industrial Triangle, Kahuta Road, Islamabad
Manufacturer firm M/s Vision Pharmaceuticals.
Plot # 22,23, Industrial Triangle, Kahuta Road, Islamabad
Brand Name Calador 400mg/100ml IV Infusion
Imipenem Monohydrate/Cilastatin Sodium

Name, address of Manufacturing site. M/s Wallace Pharma Evolution Kala Wala Stop, 20
Km, Lahore Jaranwala Road, Lahore
GMP status of the manufacturer New DML granted vide license No. 000951 dated
23.12.2021
Evidence of approval of manufacturing facility New DML granted vide license No. 000951 dated
23.12.2021
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Imastin 1gm Injection
Pharmaceutical ingredient (API) per unit Imipenem as Monohydrate…500mg
Cilastatin as Sodium…500mg
Pharmaceutical form of applied drug Dry Powder Injection
Pharmacotherapeutic Group of (API) Carbapenem antibiotic
The status in reference regulatory authorities Primaxin Injection USFDA
For generic drugs (me-too status) Tienam Injection of OBS Pakistan Karachi
Name and address of API manufacturer. M/S Sun Pharmaceutical Industries Limited,
Industrial Area No. 3 A.B. Road, Dewas 455 001
(MP), India.
Evaluation by PEC:
The applied product to be manufactured by M/s Wallace Pharma Evolution Kala Wala Stop, 20 Km, Lahore
Jaranwala Road, Lahore have already been approved by Registration Board in its 323rd meeting based on
Applicant firm M/s Wallace Pharma Evolution Kala Wala Stop, 20 Km, Lahore
Jaranwala Road, Lahore
Manufacturer firm M/s Wallace Pharma Evolution Kala Wala Stop, 20 Km, Lahore
Brand Name Nemcil 500mg/5000mg injection
23.12.2021
23.12.2021
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Imastin 500mg Injection
Pharmaceutical ingredient (API) per unit Imipenem (as monohydrate).……250mg
Cilastatin (as sodium)……………250mg
(MP), India.
Evaluation by PEC:
137. Name, address of Applicant / Marketing M/s Wnsfeild Pharmaceuticals.
Authorization Holder Plot # 122, Block A, Phase V, Hattar Industrial
Estate, Hattar
23.12.2021
23.12.2021
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Imsetin 1gm Injection
Pharmaceutical ingredient (API) per unit Imipenem as Monohydrate…500mg
(MP), India.
Evaluation by PEC:
Estate, Hattar
23.12.2021
23.12.2021
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Imsetin 500mg Injection
(MP), India.
Evaluation by PEC:
139. Name, address of Applicant / Marketing M/s Harmann Pharmaceutical Laboratories Pvt
Authorization Holder Ltd.
16 Km, Multan Road, Lahore
Name, address of Manufacturing site. M/s Global Pharmaceuticals Pvt Ltd Plot # 204-205,
Industrial Triangle, Kahuta Road, Islamabad
GMP status of the manufacturer Global pharmaceuticals: 11 & 24-10-2018: On the
basis of findings, panel unanimously decided to
recommend the issuance of GMP certificate.
Evidence of approval of manufacturing facility Firm has submitted copy of letter of Grant of
additional section / amendment under DML No
000417 of M/s Global Pharmaceuticals Islamabad
dated 18-12-2017 specifying reallocation of dry
powder injection (carbapenem) section in place of
withdrawn Biotech section (BSF)
☐ Export sale
submitted 07-2022
The proposed proprietary name / brand name Xienam 500mg Injection
Pharmaceutical form of applied drug White to pale yellow powder filled in clear glass vials
with grey rubber stopper and blue color flip off seal
The status in reference regulatory authorities Primaxin Injection (USFDA Approved)
For generic drugs (me-too status) Onem Injection of Global Pharmaceuticals
Name and address of API manufacturer. M/s ACS DOBFAR S.p.A Viale Addetta 2a/12-
3/5 20067 Tribiano, Milano- Italy
Evaluation by PEC:
The applied product to be manufactured by M/s Global Pharmaceuticals Pvt Ltd Plot # 204-205, Industrial
Triangle, Kahuta Road, Islamabad have already been approved by Registration Board in its 323rd meeting
Applicant firm M/s Swiss Pharmaceuticals (Pvt) Ltd. A/159, SITE, Super
Highway Karachi.
Manufacturer firm M/s Global Pharmaceuticals Pvt Ltd
Plot # 204-205, Industrial Triangle, Kahuta Road, Islamabad
Brand Name CILSNIM 500mg Injection IV
140. Name, address of Applicant / Marketing M/s Reliance Pharma. Plot No 8, Street No. S-8,
Authorization Holder Industrial Estate, Rawat, Islamabad
Name, address of Manufacturing site. M/s Global Pharmaceuticals Pvt Ltd
Plot # 204-205, Industrial Triangle, Kahuta Road,
Islamabad
GMP status of the manufacturer Global pharmaceuticals: 11 & 24-10-2018: On the
basis of findings, panel unanimously decided to
recommend the issuance of GMP certificate.
000417 of M/s Global Pharmaceuticals Islamabad
dated 18-12-2017 specifying reallocation of dry
powder injection (carbapenem) section in place of
withdrawn Biotech section (BSF)
☐ Export sale
submitted 09-2021
The proposed proprietary name / brand name Imicil 500mg IV Injection
The status in reference regulatory authorities Primaxin Injection (USFDA Approved)
For generic drugs (me-too status) Onem Injection of Global Pharmaceuticals
Name and address of API manufacturer. M/s ACS DOBFAR S.p.A Viale Addetta 2a/12-
3/5 20067 Tribiano, Milano- Italy
Evaluation by PEC:
Triangle, Kahuta Road, Islamabad have already been approved by Registration Board in its 323rd meeting
Highway Karachi.
Manufacturer firm M/s Global Pharmaceuticals Pvt Ltd
Plot # 204-205, Industrial Triangle, Kahuta Road, Islamabad
Brand Name CILSNIM 500mg Injection IV
Ferric Carboxymaltose

Road, Lahore
GMP status of the manufacturer GMP certificate issued on the basis of inspection
conducted on 17& 18-01-2019
Evidence of approval of manufacturing facility GMP certificate issued on the basis of inspection
conducted on 17& 18-01-2019, declares
section.
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Sarferric 500mg/10ml Injection
Pharmaceutical ingredient (API) per unit Iron as Ferric Carboxymaltose…50mg/ml
Pharmaceutical form of applied drug IV Liquid injection
Pharmacotherapeutic Group of (API) Iron preparation
For generic drugs (me-too status) Ferotox 50mg/ml Injection of M/s Wilshire
Laboratories Reg.# 108356
Name and address of API manufacturer. M/s Nanjing Hancer Pharmaceutical Co., Ltd.,
China, No. 18 Hichang Road, Lishui Economi
Technlogical Development one Jiangsu, China.
Evaluation by PEC:
320th meeting based on the data of same batches of drug product as submitted in the instant case. The
details of the already approved product are as follows:
Applicant firm M/s Aptcure Pvt Ltd. 8- Pharma City, 30 km Multan Road,
Lahore
Manufacturer firm M/s English Pharmaceuticals Industries Link Kattar Bund
Brand Name Greeninject 50mg/ml Injection
Road, Lahore
section.
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Haem 50mg/ml Injection
Evaluation by PEC:
Lahore
143. Name, address of Applicant / Marketing M/s Islam Pharmaceuticals.
Authorization Holder 7 km, Pasrur Road, Sialkot
Road, Lahore
section.
☐ Export sale
submitted 01-2023
The proposed proprietary name / brand name Feroxy 50mg/ml Injection
Evaluation by PEC:
Lahore
Isotretinoin

dated 14-02-2020 which specifies Soft gelatin Capsule
(General) section.
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Isovin 20mg Capsule
Strength / concentration of drug of Active Each Softgel Capsule Contains:
Pharmaceutical ingredient (API) per unit Isotretinoin…20mg
Pharmaceutical form of applied drug Yellow color soft gel capsule containing yellow color
liquid
Pharmacotherapeutic Group of (API) Retinoids for treatment of acne
Reference to Finished product specifications BP
The status in reference regulatory authorities Isotretinoin 20 mg soft capsules (MHRA Approved)
For generic drugs (me-too status) Oratane Capsule by Crystolite
Name and address of API manufacturer. Chongqing Huapont Shengchem Pharmaceutical Co.
Ltd No. 666 Rongjun Road, Nanjin Avenue, Hechuan
District, Changqin China.
Evaluation by PEC:
Rawalpindi
Rawalpindi
Brand Name BIOTAN 20mg Capsule
145. Name, address of Applicant / Marketing M/s Jenner Pharmaceuticals Pvt Ltd.
Authorization Holder 26-km, Lahore Sharaqpur Road, Sheikhupura
(General) section.
☐ Export sale
submitted 12-2022
The proposed proprietary name / brand name Jentret 20mg Soft Gelatin Capsule
liquid
Evaluation by PEC:

Rawalpindi
Rawalpindi
146. Name, address of Applicant / Marketing M/s Dyson Research Laboratories Pvt Ltd.
Authorization Holder 28 km Ferozepur Road Lahore
(General) section.
☐ Export sale
submitted 11-2022
The proposed proprietary name / brand name Acesoft 20mg Soft Gelatin Capsule
liquid
Evaluation by PEC:

Rawalpindi
Rawalpindi
147. Name, address of Applicant / Marketing M/s World Biz Pharmaceuticals Company.
Authorization Holder 340, Phase II, Industrial Estate, Multan, Pakistan
(General) section.
☐ Export sale
Dy. No. and date of submission & Details of fee Dy.No 48 dated 02-01-2023 Rs.75,000/- dated 09-12-
submitted 2022
The proposed proprietary name / brand name Isomax 20mg Soft Gelatin Capsule
liquid
Evaluation by PEC:

Rawalpindi
Rawalpindi
(General) section.
☐ Export sale
submitted 10-2022
The proposed proprietary name / brand name Isonide 20mg Capsule
liquid
Evaluation by PEC:

Rawalpindi
Rawalpindi
Rawat, Rawalpindi
(General) section.
☐ Export sale
submitted 06-2022
The proposed proprietary name / brand name Tretiwan 20mg Softgel Capsule
liquid
Evaluation by PEC:

Rawalpindi
Rawalpindi
Rawat, Rawalpindi
(General) section.
☐ Export sale
submitted 06-2022
The proposed proprietary name / brand name Tretiwan 10mg Softgel Capsule
liquid
Evaluation by PEC:

Rawalpindi
Rawalpindi
(General) section.
☐ Export sale
submitted 10-2022
The proposed proprietary name / brand name Isonide 10mg Capsule
liquid
Evaluation by PEC:

Rawalpindi
Rawalpindi
Lefamulin
Pakistan
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Lefaa 600mg Tablet
Pharmaceutical ingredient (API) per unit Lefamulin as Acetate……..600mg
Pharmaceutical form of applied drug Antibacterial
Pharmacotherapeutic Group of (API) Immediate release film coated tablet
Reference to Finished product specifications Innovator’s specifications
The status in reference regulatory authorities Xenelta 600mg tablet, USFDA Approved.
Name and address of API manufacturer. M/s Kaifeng Pharmaceutical (Group) Company
Limited, No. 1, Yunan street, Kaifeng Henan,
Province, China.
Evaluation by PEC:
Brand Name Lefazon tablet 600mg
Megesterol Acetate
153. Name, address of Applicant / Marketing M/s Wenovo Pharmaceuticals
Authorization Holder Plot # 31& 32 Punjab Small Industrial Estate
Taxila Pakistan
Hattar
Evidence of approval of manufacturing facility Tablet (steroidal hormonal) section is approved dated
18.01.2019 vide letter no. F.3-2/2006-Lic (Vol-II)
submitted 07-2023
The proposed proprietary name / brand name Jestro 160mg Tablet
Pharmaceutical ingredient (API) per unit Megestrol Acetate …….160mg
Pharmacotherapeutic Group of (API) Hormone related agent. (L02AB01)
The status in reference regulatory authorities MHRA Approved.
For generic drugs (me-too status) Progace 160mg tablet by M/s Medinet
Pharmaceuticals, Rwp
Zhejiang Xianju Yangguang Bioproduct Co. Ltd.
China
Evaluation by PEC:
The applied product to be manufactured by M/s WnsFeild Pharmaceutical Plot No. 122, Block-A, Phase
V, Industrial Estate Hattar KPK Pakista have already been approved by Registration Board in its 324 th
Applicant firm M/s WnsFeild Pharmaceutical Plot No. 122, Block-A, Phase V,
Industrial Estate Hattar KPK Pakistan.
Manufacturer firm M/s WnsFeild Pharmaceutical Plot No. 122, Block-A, Phase V,
Brand Name
Mygest 160mg Tablet
Hattar, Pakistan
Hattar
submitted 07-2023
The proposed proprietary name / brand name Myggo 160mg Tablet
China
Evaluation by PEC:
Brand Name
Mygest 160mg Tablet
Hattar, KPK
Hattar
submitted 07-2023
The proposed proprietary name / brand name Majest 160mg Tablet
China
Evaluation by PEC:
Brand Name
Mygest 160mg Tablet
Authorization Holder Plot #122 Phase 5, Block B, Industrial Hattar
Hattar
submitted 07-2023
The proposed proprietary name / brand name Mygeso 160mg Tablet
China
Evaluation by PEC:
Brand Name
Mygest 160mg Tablet
Lahore
Hattar
submitted 07-2023
The proposed proprietary name / brand name Mestrol 160mg Tablet
China
Evaluation by PEC:
Brand Name
Mygest 160mg Tablet
Meropenem
Road, Lahore
Name, address of Manufacturing site. M/s Nicholas Pharmaceuticals, plot # 34, St # SS-02
National industrial Zone Rawat Islamabad
☐ Importer
GMP status of the manufacturer cGMP certificate of M/s Nicholas Pharmaceuticals
on the basis of inspection conducted on 28-01-2020
Evidence of approval of manufacturing facility cGMP certificate of M/s Nicholas Pharmaceuticals
specifying Dry Vial Injection section (Carbapenem).
☐ Export sale
The proposed proprietary name / brand name Merop 500mg Injection
Pharmaceutical ingredient (API) per unit Meropenem (as trihydrate)……500mg
(blended with sodium carbonate)
Pharmaceutical form of applied drug White or almost white, hygroscopic, crystalline,
powder filled in clear glass vials
Proposed Pack size 1’s
The status in reference regulatory authorities Merrem Injection (USFDA Approved)
For generic drugs (me-too status) Merrem Injection of Global Pharmaceuticals
Name and address of API manufacturer. Rajasthan Antibiotics Ltd. Plot No. 619 & 630
RIICO Industrial Area Bhiwadi – District Alwar
Rajasthan India.
Evaluation by PEC:
The applied product to be manufactured by M/s Nicholas Pharmaceuticals, plot # 34, St # SS-02 National
industrial Zone Rawat Islamabad has already been approved by Registration Board in its 307th meeting
based on the data of same batches of drug product as submitted in the instant case. The details of the
already approved product are as follows:
Applicant firm M/s McColson Research Laboratories, 26km Lahore

Sheikhupura Road, Sheikhupura
Manufacturer firm M/s Nicholas Pharmaceuticals, plot # 34, St # SS-02 National
industrial Zone Rawat Islamabad
Brand Name RONEM 500 mg Injection IV
Road, Lahore
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy.No 17578dated 13-07-2023
The proposed proprietary name / brand name Merop 1gm Injection
Pharmaceutical ingredient (API) per unit Meropenem (as trihydrate)……1gm
Rajasthan India.
Evaluation by PEC:

Brand Name RONEM 1gm Injection IV
Taxila Pakistan
Name, address of Manufacturing site. M/s Wallace Pharma Evolution Kala Wala
Stop, 20 Km, Lahore Jaranwala Road, Lahore
☐ Importer
23.12.2021
Evidence of approval of manufacturing facility New DML granted vide license No. 000951
dated 23.12.2021specifying grant of dry powder
injection (carbapenem) section.
☐ Export sale
The proposed proprietary name / brand name Nopem 500mg Injection
Name and address of API manufacturer. CSPC Zhongnuo Pharmaceutical (Shijiazhuang)
Co., Ltd. Address: No. 88 Yangzi Road, Economic
& Technological Development Zone, Shijiazhuang
City, Hebei Province, China.
Evaluation by PEC:
The applied product to be manufactured by M/s Wallace Pharma Evolution Kala Wala Stop, 20 Km,
Lahore Jaranwala Road, Lahore has already been approved by Registration Board in its 323rd meeting
Applicant firm M/s Wallace Pharma Evolution Kala Wala Stop, 20 Km,
Lahore Jaranwala Road, Lahore
Manufacturer firm M/s Wallace Pharma Evolution Kala Wala Stop, 20 Km,
Brand Name ROPEN 500 mg Injection IV
Decision: The Board noted the information and decided to consider the application on its turn
as per Que or as per the direction of DRAP Authority, which ever is earlier.
Taxila Pakistan
☐ Importer
23.12.2021
☐ Export sale
The proposed proprietary name / brand name Nopem 1gm Injection
Name and address of API manufacturer. M/s CSPC Zhongnuo Pharmaceutical
(Shijiazhuang) Co. Ltd. No. 88, Yangzi Road,
Shijiazhuang Economic and Technological
Development Zone, Hebei Province PR. China.
Evaluation by PEC:
Lahore Jaranwala Road, Lahore has already been approved by Registration Board in its 320th meeting
Brand Name ROPEN 1GM Injection IV
Authorization Holder Factory G.T. Road, Industrial Estate,
Gujranwala Cantt.
☐ Importer
23.12.2021
☐ Export sale
Details of fee submitted Rs.75,000/-
The proposed proprietary name / brand name Myrona 500mg Injection
Evaluation by PEC:
Authorization Holder Factory G.T. Road, Industrial Estate,
Gujranwala Cantt.
☐ Importer
23.12.2021
☐ Export sale
Details of fee submitted Rs.75,000/-
The proposed proprietary name / brand name Myrona1gm Injection
Evaluation by PEC:
Rawat
☐ Importer
23.12.2021
☐ Export sale
The proposed proprietary name / brand name Mopina 500mg Injection
Evaluation by PEC:
Rawat
☐ Importer
23.12.2021
☐ Export sale
The proposed proprietary name / brand name Mopina 1gm Injection
Evaluation by PEC:
Authorization Holder Plot #122 Phase 5, Block B, Industrial Hattar
☐ Importer
23.12.2021
☐ Export sale
The proposed proprietary name / brand name Meprox 500mg Injection
Evaluation by PEC:
☐ Importer
23.12.2021
☐ Export sale
The proposed proprietary name / brand name Meprox 1gm Injection
Evaluation by PEC:
168. Name, address of Applicant / Marketing M/s World Biz Pharmaceuticals Company
Authorization Holder Plot No. 340 Multan Industrial Estate Multan
Name, address of Manufacturing site. M/s Stallion Pharmaceuticals Pvt Ltd.
581-Sundar Industrial Estate, Lahore, Pakistan
☐ Importer
GMP status of the manufacturer Stallion Pharmaceuticals: Firm has submitted
GMP certificate issued on the basis of inspection
dated 22-09-2020.
000783 of M/s Stallion Pharma Islamabad dated 08-
02-2016 specifying dry powder injection Vial
(carbapenem) section.
☐ Export sale
The proposed proprietary name / brand name Merobiz 500mg IV Injection
Name and address of API manufacturer. M/s Aurobindo Pharma Limited Unit-V, Plot No.
68-70, 73-91, 95, 96, 260, 261 I.D.A Chemical
Zone, Pashamylaram, Patancheru Mandal, Sanga
Reddy District Telangana, India.
Evaluation by PEC:
The applied product to be manufactured by M/s Stallion Pharmaceuticals Pvt Ltd. 581-Sundar
Industrial Estate, Lahore, Pakistan has already been approved by Registration Board in its 323 rd
meeting based on the data of same batches of drug product as submitted in the instant case. The details
Applicant firm M/s Aspin Pharma (Pvt) Ltd. Plot No. 10 & 25 Sector 20,
Korangi Industrial Area Karachi.
Manufacturer firm M/s Stallion Pharmaceuticals Pvt Ltd.
Brand Name ASPINEM 500 mg Injection IV
☐ Importer
GMP status of the manufacturer Stallion Pharmaceuticals: Firm has submitted
GMP certificate issued on the basis of inspection
dated 22-09-2020.
000783 of M/s Stallion Pharma Islamabad dated 08-
02-2016 specifying dry powder injection Vial
(carbapenem) section.
☐ Export sale
The proposed proprietary name / brand name Merobiz 1gm IV Injection
Name and address of API manufacturer. M/s Aurobindo Pharma Limited Unit-V, Plot No.
68-70, 73-91, 95, 96, 260, 261 I.D.A Chemical
Zone, Pashamylaram, Patancheru Mandal, Sanga
Reddy District Telangana, India.
Evaluation by PEC:
The applied product to be manufactured by M/s Stallion Pharmaceuticals Pvt Ltd. 581-Sundar
Industrial Estate, Lahore, Pakistan has already been approved by Registration Board in its 323 rd
Applicant firm M/s Aspin Pharma (Pvt) Ltd. Plot No. 10 & 25 Sector 20,
Korangi Industrial Area Karachi.
Manufacturer firm M/s Stallion Pharmaceuticals Pvt Ltd.
Brand Name ASPINEM 1gm Injection
Authorization Holder Plot No. 69/1, Block B, Phase I-II, Industrial
Estate, Hattar, Pakistan
☐ Importer
23.12.2021
☐ Export sale
The proposed proprietary name / brand name Ropen 500mg IV Injection
Evaluation by PEC:
☐ Importer
23.12.2021
☐ Export sale
The proposed proprietary name / brand name ROPEN 1gm IV Injection
Evaluation by PEC:
☐ Importer
23.12.2021
☐ Export sale
Evaluation by PEC:
☐ Importer
23.12.2021
☐ Export sale
Evaluation by PEC:
Estate, Hattar
☐ Importer
23.12.2021
☐ Export sale
Evaluation by PEC:
Estate, Hattar
☐ Importer
23.12.2021
☐ Export sale
Evaluation by PEC:
176. Name, address of Applicant / Marketing M/s Fresh Pharmaceuticals.
Authorization Holder Plot No. 7, Street No. S-6, National Industrial
Name, address of Manufacturing site. M/s Global Pharmaceuticals (Pvt) Ltd. Plot No.
204-205, Industrial Triangle Kahuta Road
Islamabad.
☐ Importer
GMP status of the manufacturer Firm has submitted copy of GMP certificate
dated 04-01-2022 issued on the basis of
inspection dated 03-01-2022.
000417 of M/s Global Pharmaceuticals
Islamabad dated 18-12-2017 specifying
reallocation of dry powder injection
(carbapenem) section in place of withdrawn
Biotech section (BSF)
☐ Export sale
The proposed proprietary name / brand name Fropen 500mg Injection
Evaluation by PEC:
The applied product to be manufactured by M/s Global Pharmaceuticals (Pvt) Ltd. Plot No. 204-205,
Industrial Triangle Kahuta Road Islamabad has already been approved by Registration Board in its
Highway Karachi
Manufacturer firm M/s Global Pharmaceuticals (Pvt) Ltd. Plot No. 204-205,
Brand Name MEPEN 500 mg Injection IV
Islamabad.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Aeropen 500mg IV Injection
Evaluation by PEC:
Highway Karachi
Islamabad.
☐ Importer
dated 14-02-2020 which specifies Carbapenem
Injection section.
☐ Export sale
The proposed proprietary name / brand name Aeropen 1gm IV Injection
Evaluation by PEC:
Highway Karachi
179. Name, address of Applicant / Marketing M/s Pharmedic Laboratories Pvt Ltd.
Authorization Holder 16-km, Multan Road Lahore, Pakistan
Islamabad.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Meronac 500mg IV Injection
Evaluation by PEC:
Highway Karachi
Islamabad.
☐ Importer
Injection section.
☐ Export sale
The proposed proprietary name / brand name Meronac 1gm IV Injection
Evaluation by PEC:
Highway Karachi
181. Name, address of Applicant / Marketing M/s Helix Pharma Pvt Ltd.
Authorization Holder Hakimsons House, A/56, S.I.T.E Manghopir
Road, Karachi, Pakistan
Islamabad.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Hipem 500mg IV Injection
Evaluation by PEC:
Highway Karachi
182. Name, address of Applicant / Marketing M/s Helix Pharma Pvt Ltd.
Authorization Holder Hakimsons House, A/56, S.I.T.E Manghopir
Road, Karachi, Pakistan
Islamabad.
☐ Importer
Injection section.
☐ Export sale
The proposed proprietary name / brand name Hipemc1gm IV Injection
Evaluation by PEC:
Highway Karachi
Authorization Holder Ltd.
16 Km, Multan Road, Lahore
Islamabad.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Mero-X 500mg IV Injection
Evaluation by PEC:
Highway Karachi
184. Name, address of Applicant / Marketing M/s Martin Dow Marker Limited.
Authorization Holder 7, Jail Road, Quetta, Pakistan
Islamabad.
☐ Importer
Injection section.
☐ Export sale
The proposed proprietary name / brand name Mero-X 1gm IV Injection
Evaluation by PEC:
Highway Karachi
Islamabad.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Meropen 500mg IV Injection
Evaluation by PEC:
Highway Karachi
Islamabad.
☐ Importer
Injection section.
☐ Export sale
The proposed proprietary name / brand name Meropen 1gm IV Injection
Evaluation by PEC:
Highway Karachi
187. Name, address of Applicant / Marketing M/s Faas Pharmaceuticals (Pvt.) Ltd.
Authorization Holder F-748/L, S.I.T.E Karachi, Pakistan
Islamabad.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Parem 500mg IV Injection
Evaluation by PEC:
Highway Karachi
Islamabad.
☐ Importer
Injection section.
☐ Export sale
The proposed proprietary name / brand name Parem 1gm IV Injection
Evaluation by PEC:
Highway Karachi
Brand Name MEPEN 1gm Injection IV
189. Name, address of Applicant / Marketing M/s AGP Limited.B-23, S.I.T.E. Karachi
Authorization Holder
Name, address of Manufacturing site. M/s Biogen Pharmaceuticals 8Km, Chakbeli
Road Rawat, Rawalpindi
☐ Importer
Injection section.
☐ Export sale
The proposed proprietary name / brand name Mi-Penem 500mg IV Injection
Rajasthan India.
Evaluation by PEC:
The applied product to be manufactured by M/s Biogen Pharmaceuticals 8Km, Chakbeli Road Rawat,
Rawalpindi has already been approved by Registration Board in its 312th meeting based on the data
of same batches of drug product as submitted in the instant case. The details of the already approved

Rawalpindi
Rawalpindi
Brand Name Merogen 500 mg Injection IV
190. Name, address of Applicant / Marketing M/s AGP Limited. B-23, S.I.T.E. Karachi
☐ Importer
Injection section.
☐ Export sale
The proposed proprietary name / brand name Mi-Penem 1gm IV Injection
Rajasthan India.
Evaluation by PEC:

Rawalpindi
Rawalpindi
Brand Name Merogen 1gm Injection IV
Sheikhupura
☐ Importer
Injection section.
☐ Export sale
The proposed proprietary name / brand name Merofit 500mg IV Injection
Rajasthan India.
Evaluation by PEC:

Rawalpindi
Rawalpindi
Sheikhupura
☐ Importer
Injection section.
☐ Export sale
The proposed proprietary name / brand name Merofit 1gm IV Injection
Rajasthan India.
Evaluation by PEC:

Rawalpindi
Rawalpindi
Authorization Holder Plot No. 37, Road: Ns-01, National Industrial
Zone, Rawat, Rawalpindi
☐ Importer
Injection section.
☐ Export sale
The proposed proprietary name / brand name Meron 500mg IV Injection
Rajasthan India.
Evaluation by PEC:

Rawalpindi
Rawalpindi
☐ Importer
Injection section.
☐ Export sale
The proposed proprietary name / brand name Meron 1gm IV Injection
Rajasthan India.
Evaluation by PEC:

Rawalpindi
Rawalpindi
195. Name, address of Applicant / Marketing M/s May & Baker (Pvt) Ltd.
Authorization Holder 45-km Dina Nath, Multan Road, Lahore
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Pynum 500mg Injection
Rajasthan India.
Evaluation by PEC:

196. Name, address of Applicant / Marketing M/s May & Baker (Pvt) Ltd.
Authorization Holder 45-km Dina Nath, Multan Road, Lahore
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Pynum 1gm injection
Rajasthan India.
Evaluation by PEC:

197. Name, address of Applicant / Marketing M/s Safe Pharmaceuticals Pvt Ltd.
Authorization Holder Plot No. C.I-20, Sector 6-B, Industrial Area,
North Karachi
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Safepenem 500mg Injection
Rajasthan India.
Evaluation by PEC:

198. Name, address of Applicant / Marketing M/s Mapel Pharmaceuticals Pvt Ltd.
Authorization Holder Plot No. 147, Sector 23, Korangi Indusrial Area,
Karachi, Pakistan
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Safepenem 1G Injection
Pharmaceutical ingredient (API) per unit Meropenem (as trihydrate)……1gmmg
Rajasthan India.
Evaluation by PEC:

Karachi, Pakistan
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Meromap 500mg Injection
Rajasthan India.
Evaluation by PEC:

Karachi, Pakistan
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Meromap 1gm Injection
Rajasthan India.
Evaluation by PEC:

Name, address of Manufacturing site. M/s Bio-Next Pharmaceuticals Plot No. 50, St No. S-
10, RCCI Industrial Estate Rawat Islamabad.
☐ Importer
GMP status of the manufacturer Firm has been granted new DML by way of
formulation dated 06-11-2019.
Evidence of approval of manufacturing facility Firm has submitted copy of Section approval letter
dated 06-11-2019 specifying Dry Vial Injection
section (Carbapenem).
☐ Export sale
The proposed proprietary name / brand name Mytox 500mg IV Injection
Rajasthan India.
Evaluation by PEC:
The applied product to be manufactured by M/s Bio-Next Pharmaceuticals Plot No. 50, St No. S-10,
RCCI Industrial Estate Rawat Islamabad has already been approved by Registration Board in its 296th
Applicant firm M/s Bio-Next Pharmaceuticals Plot No. 50, St No. S-10, RCCI
Industrial Estate Rawat Islamabad.
Manufacturer firm M/s Bio-Next Pharmaceuticals Plot No. 50, St No. S-10, RCCI
Brand Name MENEPOR 500 mg Injection IV
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Mytox 1gm IV Injection
Rajasthan India.
Evaluation by PEC:
The applied product to be manufactured by M/s Bio-Next Pharmaceuticals Plot No. 50, St No. S-10, RCCI
Industrial Estate Rawat Islamabad has already been approved by Registration Board in its 296th meeting
Brand Name MENEPOR 1gmInjection IV
203. Name, address of Applicant / Marketing M/s Nawan Laboratories (Pvt) Ltd.
Authorization Holder 136 sector 15 Korangi Industrial Area Karachi.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Merotyl 500mg IV Injection
Rajasthan India.
Evaluation by PEC:
204. Name, address of Applicant / Marketing M/s Nawan Laboratories (Pvt) Ltd.
Authorization Holder 136 sector 15 Korangi Industrial Area Karachi.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Merotyl 1gm IV Injection
Rajasthan India.
Evaluation by PEC:
Brand Name MENEPOR 1gm Injection IV
205. Name, address of Applicant / Marketing M/s Avant Pharmaceuticals.
Authorization Holder M-028 H.I.T.E, Lasbela, Balochistan
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Avepenam 500mg IV Injection
Rajasthan India.
Evaluation by PEC:
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Avepenam 1gm IV Injection
Rajasthan India.
Evaluation by PEC:
Pakistan
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Meroposh 500mg IV Injection
Rajasthan India.
Evaluation by PEC:
Pakistan
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Meroposh 1gm IV Injection
Rajasthan India.
Evaluation by PEC:
209. Name, address of Applicant / Marketing M/s Linear Pharma Plot # 18, Street # S-4,
Authorization Holder National Industrial Zone, RCCI Rawat,
islamabad
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Nibac 500mg IV Injection
Rajasthan India.
Evaluation by PEC:
210. Name, address of Applicant / Marketing M/s Linear Pharma Plot # 18, Street # S-4,
Authorization Holder National Industrial Zone, RCCI Rawat,
islamabad
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Meripan 1gm IV Injection
Rajasthan India.
Evaluation by PEC:
Brand Name MENEPOR 1gm Injection IV
211. Name, address of Applicant / Marketing M/s Fassgen Pharmaceuticals Plot No. 67/1-A,
Authorization Holder Phase-III, Industral Estate, Hattar
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Menepor 500mg IV Injection
Rajasthan India.
Evaluation by PEC:
212. Name, address of Applicant / Marketing M/s Fassgen Pharmaceuticals Plot No. 67/1-A,
Authorization Holder Phase-III, Industral Estate, Hattar
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Menepor 1g IV Injection
Rajasthan India.
Evaluation by PEC:
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Meripan 500mg IV Injection
Rajasthan India.
Evaluation by PEC:
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Meripan 1gm IV Injection
Rajasthan India.
Evaluation by PEC:
Nalbuphine HCl
Rawat, Rawalpindi
dated 14-02-2020 which specifies Liquid Injectable
section.
☐ Export sale
submitted 10-2022
The proposed proprietary name / brand name Bufan 10mg/ml injection
Pharmaceutical ingredient (API) per unit Nalbuphine HCl………10mg
Pharmaceutical form of applied drug Clear and colourless solution filled in glass ampoules
Pharmacotherapeutic Group of (API) Morphinan derivatives
Reference to Finished product specifications Manufacturer’s specifications
The status in reference regulatory authorities Nalbuphine Injection 10mg/ml (USFDA Approved)
For generic drugs (me-too status) Nalbin Injection by Global Pharma
Name and address of API manufacturer. Mallinckrodt Pharmaceuticals SpecGx LLC 3600
North Second Street St. Louis, Missouri
Evaluation by PEC:

Rawalpindi
Rawalpindi
Brand Name BIONAL Injection 10mg/mL
Rawat, Rawalpindi
dated 14-02-2020 which specifies Liquid Injectable
section.
☐ Export sale
submitted 10-2022
The proposed proprietary name / brand name Bufan 20mg/ml injection
Pharmaceutical ingredient (API) per unit Nalbuphine HCl………20mg
Pharmaceutical form of applied drug Clear and colourless solution filled in glass ampoules
Pharmacotherapeutic Group of (API) Morphinan derivatives
The status in reference regulatory authorities Nalbuphine Injection 20mg/ml (USFDA Approved)
For generic drugs (me-too status) Nalbin Injection by Global Pharma
Name and address of API manufacturer. Mallinckrodt Pharmaceuticals SpecGx LLC 3600
North Second Street St. Louis, Missouri
Evaluation by PEC:

Rawalpindi
Rawalpindi
Brand Name BIONAL Injection 20mg/mL
Omeprazole
217. Name, address of Applicant / Marketing M/s Onyx Pharmaceuticals30-A, Industrial Estate
Authorization Holder Mansehra
Name, address of Manufacturing site. M/s Bio Mark Pharmaceuticals.
Plot No. 527, Sundar Industrial Estate,Lahore
GMP status of the manufacturer cGMP certificate of M/s Bio-Mark issued based
upon Evaluation conducted on 13-02-2020
Evidence of approval of manufacturing facility cGMP certificate of M/s Bio-Mark issued based upon
Evaluation conducted on 13-02-2020 declares
availability of Capsule general setion.
☐ Export sale
submitted 05-2023
The proposed proprietary name / brand name Ozonex 20mg Capsule
Strength / concentration of drug of Active Each capsule contains: -
Pharmaceutical ingredient (API) per unit Omeprazole (as enteric coated pellets)...20mg
Pharmaceutical form of applied drug Capsule
Pharmacotherapeutic Group of (API) Proton pump inhibitors
For generic drugs (me-too status) Risek capsule 20mg by Getz Pharma Pakistan (Pvt)
Ltd, Reg. No. 019364
Name and address of API manufacturer. M/s Vision Pharmaceuticals Pvt Ltd, Plot No 22-23,
Industrial Triangle, Kahuta road, Islamabad
Evaluation by PEC:
The applied product to be manufactured by M/s Bio-Mark Pharmaceuticals Plot No. 527, Sundar Industrial
Estate Lahore have already been approved by Registration Board in its 329th meeting based on the data of
are as follows:
Applicant firm M/s Sapient Pharma, 123/S, 104/S, Industrial area Kot Lakhpat,
Lahore.
Manufacturer firm M/s Bio-Mark Pharmaceuticals Plot No. 527, Sundar
Industrial Estate Lahore
Brand Name Gosoft 20mg capsule
Omeprazole Sodium
Name, address of Manufacturing site. M/s Variant pharmaceuticals (Pvt) Ltd, Plot No. 5,
M-2, Pharmazone, 26 Km, Lahore Sharikpur Road,
Sheikhupura.
recommendations of CLB in its 273rd meeting held
on 15th January, 2020
(pre-lyophilized) vial section (General) vide letter
No. F. 1-1/2016-Lic of licensing division.
☐ Export sale
Dy. No. and date of submission & Details of fee Dy.No 16625 dated 04-07-2023 Rs.75,000/- dated
submitted 16-03-2023
The proposed proprietary name / brand name Omelip 40gm IV Injection
Pharmaceutical ingredient (API) per unit Omeprazole as sodium ------- 40 mg
The status in reference regulatory authorities Omeprazole 40mg IV Injection of M/s Lek
Pharmaceuticals (MHRA approved)
For generic drugs (me-too status) Risek 40mg IV powder for solution of M/s GETZ
Pharma (Reg # 024170)
Name and address of API manufacturer. M/s Vision pharmaceuticals (pvt) Ltd., Plot no. 22-
23, Industrial Triangle, Kahuta Road, Islamabad.
Evaluation by PEC:
Brand Name Varizole 40mg Injection
Authorization Holder 17-Km, Peerwala Morr, Qader Pur Ban,
Khanewal Road, District Multan
Road, Lahore
approval.
☐ Export sale
The proposed proprietary name / brand name Sar-Omep 40mg Powder for Injection
The status in reference regulatory authorities Omeprazole 40mg Powder for Solution for Infusion
(MHRA)
For generic drugs (me-too status) Risek 40 mg IV injection
By M/S Getz Pharma
Name and address of API manufacturer. M/s Vision Pharmaceuticals (Pvt) Ltd.
Plot No.22-23, Industrial Triangle, Kahuta Road,
Islamabad, Pakistan.
Evaluation by PEC:

Lahore
Brand Name Nilcid 40mg Injection
Islamabad
2022.
2022.
section
☐ Export sale
submitted 11-2022
The proposed proprietary name / brand name Seclo 40mg Injection
Name and address of API manufacturer. M/s Rajasthan Antibiotics Ltd., Plot no.A-619 &
630, Rico Industrial Area Bhiwadi-301019
Rajasthan, India
Evaluation by PEC:
Road, Islamabad have already been approved by Registration Board in its 324 th meeting based on the
Applicant firm M/s Islam Pharmaceuticals., 7 km, Pasrur Road, Sialkot.

Brand Name Mozole 40mg Injection
 The composition shall mention “Each Lyophilized Vial contains” since manufacturer had
approval of applied formulation in “Lyophilized vial (Injectable) general section.
221. Name, address of Applicant / Marketing M/s Linear Pharma
Authorization Holder Plot # 18, Street # S-4, National Industrial Zone,
RCCI Rawat, islamabad
Islamabad
2022.
2022.
section
☐ Export sale
The proposed proprietary name / brand name Ozar 40mg Injection
Name and address of API manufacturer. M/s Rajasthan Antibiotics Ltd., Plot no.A-619 &
Rajasthan, India
Evaluation by PEC:

Islamabad
2022.
2022.
section
☐ Export sale
submitted 10-2021
The proposed proprietary name / brand name Nomizil 40mg IV injection
Name and address of API manufacturer. M/s Rajasthan Antibiotics Ltd., Plot no. A-619 &
Rajasthan, India
Evaluation by PEC:

223. Name, address of Applicant / Marketing M/s Invictus Pharmaceuticals.
Authorization Holder Plot No. 21,26, Street No.NS-2, National
Industrial Zone, Rawat, Rawalpindi
Islamabad
2022.
2022.
section
☐ Export sale
submitted 09-2021
The proposed proprietary name / brand name Vrochi 40mg IV Injection
Name and address of API manufacturer. M/s Rajasthan Antibiotics Ltd., Plot no A-619 & 630,
Rico Industrial Area Bhiwadi-301019 Rajasthan,
India
Evaluation by PEC:

224. Name, address of Applicant / Marketing M/s Hoover Pharmaceuticals (Pvt) Ltd.
Authorization Holder Plot No. 16, Zain Park, Industrial Area, Saggian
Bypass Road, Lahore
Name, address of Manufacturing site. M/s Variant pharmaceuticals (Pvt) Ltd, Plot No. 5,
M-2, Pharmazone, 26 Km, Lahore Sharikpur Road,
Sheikhupura.
recommendations of CLB in its 273rd meeting held
on 15th January, 2020
(pre-lyophilized) vial section (General) vide letter
No. F. 1-1/2016-Lic of licensing division.
☐ Export sale
submitted 12-2022
The proposed proprietary name / brand name Gatolin 40mg IV Injection
Name and address of API manufacturer. M/s Vision pharmaceuticals (pvt) Ltd., Plot no. 22-
23, Industrial Triangle, Kahuta Road, Islamabad.
Evaluation by PEC:
Brand Name Varizole 40mg Injection
225. Name, address of Applicant / Marketing M/s Valor Pharmaceuticals.
Authorization Holder 124/A Industrial Triangle, Kahuta Road
Islamabad
☐ Export sale
The proposed proprietary name / brand name Omepraval IV 40mg Injection
(MHRA)
By M/S Getz Pharma
Name and address of API manufacturer. Rajasthan Antibiotics Ltd. A-619 & 630, Phase-I,
RIICO Ind. Area Bhiwadi, Distr. Alwar (Rajasthan)
India.
Evaluation by PEC:
Rawalpindi, Pakistan have already been approved by Registration Board in its 312th meeting based on

Rawalpindi
Rawalpindi
Brand Name Reflex 40mg Injection
☐ Export sale
The proposed proprietary name / brand name O-wan 40mg Injection
(MHRA)
By M/S Getz Pharma
Name and address of API manufacturer. Rajasthan Antibiotics Ltd. A-619 & 630, Phase-I,
RIICO Ind. Area Bhiwadi, Distr. Alwar (Rajasthan)
India.
Evaluation by PEC:
Rawalpindi, Pakistan have already been approved by Registration Board in its 312 th meeting based on
Rawalpindi
Rawalpindi
Brand Name Reflex 40mg Injection
227. Name, address of Applicant / Marketing M/s Macter International Limited.
Authorization Holder F-216, S.I.T.E, Karachi, Pakistan
Islamabad
☐ Export sale
The proposed proprietary name / brand name Sante 40mg Injection
Pharmaceutical ingredient (API) per unit Omeprazole sodium, equivalent to 40 mg
Omeprazole.
(MHRA)
By M/S Getz Pharma
Islamabad
Evaluation by PEC:
The applied product to be manufactured by M/s Vision Pharmaceuticals Plot # 22,23, Industrial
Triangle, Kahuta Road, Islamabad have already been approved by Registration Board in its 307 th
Applicant firm M/s Rogen Pharmaceuticals Plot No. 30, Street # S-4, National
Industrial Zone, Rawat, Islamabad
Brand Name G-Cid 40mg IV Injection
228. Name, address of Applicant / Marketing M/s Pharma Lord (Pvt) Ltd.
Authorization Holder 12 KM, Lahore Raod, Layyah, Punjab
Islamabad
☐ Export sale
The proposed proprietary name / brand name Omelor 40mg Injection
Omeprazole.
(MHRA)
By M/S Getz Pharma
Islamabad
Evaluation by PEC:
Name, address of Applicant / Marketing M/s Wimits Pharmaceuticals (Pvt.) Ltd.
229. Authorization Holder Plot No. 129, Sundar Industrial Estate, Raiwind
Road, Lahore
Road, Lahore
approval.
☐ Export sale
submitted
The proposed proprietary name / brand name Oray 40mg Powder for Injection
(MHRA)
By M/S Getz Pharma
Name and address of API manufacturer. M/s Vision Pharmaceuticals (Pvt) Ltd.
Plot No.22-23, Industrial Triangle, Kahuta Road,
Evaluation by PEC:

Lahore
Brand Name Nilcid 40mg Injection
230. Name, address of Applicant / Marketing M/s Well & Well Pharma Pvt Ltd.
Authorization Holder Plot 7, Street S-8, RCCI, National Industrial
Islamabad
☐ Export sale
The proposed proprietary name / brand name Omrel 40mg Injection
Omeprazole.
(MHRA)
By M/S Getz Pharma
Islamabad
Evaluation by PEC:
Omeprazole/Sodium bicarbonate

availability of sachet general setion.
☐ Export sale
submitted 05-2022
The proposed proprietary name / brand name Shalay 40mg/1680mg Sachet
Strength / concentration of drug of Active Each Sachet contains:
Pharmaceutical ingredient (API) per unit Omeprazole…40mg
Sodium Bicarbonate……1680mg
Pharmaceutical form of applied drug Immediate release Powder for oral suspension sachet
The status in reference regulatory authorities Zegerid® Immediate release Powder for oral
suspension of M/s Santarus is USFDA Approved
For generic drugs (me-too status) Mep-Insta Sachet 40mg/1680mg of M/s Bio-Mark
Pharmaceuticals
Name and address of API manufacturer. Omeprazole: M/s Everest Organics limited.
Regd. Office & factory: Aroor Village, Sadasivpet
Mandal, Sangareddy
Dist. Telangana
Sodium Bicarbonate: M/s TATA Chemicals Europe
Ltd., Mond House, Winnington Lane, Northwich
Cheshire, CW84DT, United
Kingdom
Evaluation by PEC:
are as follows:
Applicant firm M/s CCL Pharmaceuticals (Pvt.) Ltd.

Plot No 65-Quaid-e-Azam Industrial Estate Kot
lakhpat,Lahore.
Brand Name Faast 40mg/1680mg Sachet for oral suspension.
availability of sachet general setion.
☐ Export sale
submitted 06-2022
The proposed proprietary name / brand name Shalay 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 sachet
The status in reference regulatory authorities Zegerid® Immediate release Powder for oral
suspension of M/s Santarus is USFDA Approved
For generic drugs (me-too status) Mep-Insta Sachet 20mg/1680mg of M/s Bio-Mark
Pharmaceuticals
Name and address of API manufacturer. Omeprazole: M/s Everest Organics limited.
Regd. Office & factory: Aroor Village, Sadasivpet
Mandal, Sangareddy
Dist. Telangana
Sodium Bicarbonate: M/s TATA Chemicals Europe
Ltd., Mond House, Winnington Lane, Northwich
Cheshire, CW84DT, United
Kingdom
Evaluation by PEC:
are as follows:
Applicant firm M/s CCL Pharmaceuticals (Pvt.) Ltd.

Plot No 65-Quaid-e-Azam Industrial Estate Kot
lakhpat,Lahore.
Brand Name Faast 20mg/1680mg Sachet for oral suspension.
Ondansetron
Rawat, Islamabad
Name, address of Manufacturing site. M/s Caliph Pharmaceuticals Pvt Ltd.
Plot # 17, Special Industrial Zone, Risalpur, KPK,
Pakistan
☐ Importer
GMP status of the manufacturer GMP certificate issued to the firm on 02-03-2021
based on inspection conducted on 02-03-2021.
Evidence of approval of manufacturing facility GMP certificate issued to the firm on 02-03-2021
based on inspection conducted on 02-03-2021
declares Tablet general section availability..
☐ Export sale
The proposed proprietary name / brand name Ondex 8mg Tablet
Pharmaceutical ingredient (API) per unit Ondansetron as Hydrochloride Dihydrate……8mg
Pharmacotherapeutic Group of (API) Serotonin 5HT3 antagonist / Antiemetic
The status in reference regulatory authorities MHRA Approved (4mg and 8mg film coated tablet).
For generic drugs (me-too status) Onset 8mg tablet by M/s Pharmedic (Pvt) Ltd.
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
Evaluation by PEC:
The applied product to be manufactured by M/s Caliph Pharmaceuticals Pvt Ltd. Plot # 17, Special
Industrial Zone, Risalpur, KPK, Pakistanhas already been approved by Registration Board in its 322nd
the already approved product in 322nd meeting are as follows:
Applicant firm M/s Caliph Pharmaceuticals Pvt Ltd.

Plot # 17, Special Industrial Zone, Risalpur, KPK, Pakistan
Manufacturer firm M/s Caliph Pharmaceuticals Pvt Ltd.
Plot # 17, Special Industrial Zone, Risalpur, KPK, Pakistan
Brand Name Calsetron 8mg tablet
Name, address of Manufacturing site. M/s Wimits Pharmaceuticals (Pvt.) Ltd.
Plot No. 129, Sundar Industrial Estate, Raiwind Road,
Lahore
☐ Importer
GMP status of the manufacturer M/s Wimits Pharmaceuticals:
GMP certificate No. 70/2021 DRAP (FID / 2061717-
540) Dated: 08/09/2021
Evidence of approval of manufacturing facility M/s Wimits Pharmaceuticals:
540) Dated: 08/09/2021
Liuid injectable ampoule Section
☐ Export sale
The proposed proprietary name / brand name Sarset 8mg/4ml Injection
Strength / concentration of drug of Active Each ml contains:
Pharmaceutical ingredient (API) per unit Ondansetron as Hydrochloride Dihydrate….2mg
Pharmaceutical form of applied drug Clear colorless solution for parenteral use (IV/IM)
filled in type-I glass ampoules
8mg/4mL (PL 04543/0508)
4mg/2mL (PL 04543/0507)
For generic drugs (me-too status) Onset 8mg/4ml Injection by M/s Pharmedic (Pvt) Ltd.
Name and address of API manufacturer. M/s CTX Lifesciences Pvt. Ltd.
Address:Block No. 251-252 Sachin- Magdalla
Road GIDC, Sachin, Surat – 394 230,Gujarat,
INDIA
Evaluation by PEC:
The applied product to be manufactured by M/s Wimits Pharmaceuticals (Pvt) Ltd. Plot #129 Sundar
Industrial Estate Raiwind Road, Lahore has already been approved by Registration Board in its 326th
the already approved product in 326th meeting are as follows:
Applicant firm M/s Asian Continentals House, D-133, Tipu Sultan Road, KDA
Scheme 1, Karachi-Pakistan
Manufacturer firm M/s Wimits Pharmaceuticals (Pvt) Ltd. Plot #129 Sundar
Industrial Estate Raiwind Road, Lahore
Brand Name Stawia injection 8mg/4ml
Lahore
☐ Importer
540) Dated: 08/09/2021
540) Dated: 08/09/2021
☐ Export sale
The proposed proprietary name / brand name Sarset 4mg/2ml Injection
8mg/4mL (PL 04543/0508)
4mg/2mL (PL 04543/0507)
INDIA
Evaluation by PEC:
Lahore
☐ Importer
540) Dated: 08/09/2021
Syrup (General Human) Section
540) Dated: 08/09/2021
☐ Export sale
The proposed proprietary name / brand name Sarset 4mg/5ml Syrup
Strength / concentration of drug of Active Each 5ml Contains:
Pharmaceutical ingredient (API) per unit Ondansetron as HCl dihydrate…4mg
Pharmaceutical form of applied drug Oral liquid
Pharmacotherapeutic Group of (API) Antiemetic
The status in reference regulatory authorities Zofran Oral Solution (USFDA Approved)
For generic drugs (me-too status) Zofran Syrup by GSK
INDIA
Evaluation by PEC:
Brand Name Stawia Syrup 4mg/5ml
Lahore
☐ Importer
540) Dated: 08/09/2021
540) Dated: 08/09/2021
Tablet general section
☐ Export sale
The proposed proprietary name / brand name Genset 8mg Tablet
INDIA
Evaluation by PEC:
Brand Name Stawia 8mg tablet
Lahore
☐ Importer
540) Dated: 08/09/2021
540) Dated: 08/09/2021
Tablet general section
☐ Export sale
The proposed proprietary name / brand name Genset 4mg Tablet
INDIA
Evaluation by PEC:
Brand Name Stawia 4mg tablet
Lahore
☐ Importer
540) Dated: 08/09/2021
540) Dated: 08/09/2021
☐ Export sale
The proposed proprietary name / brand name Genset 8mg/4ml Injection
8mg/4mL (PL 04543/0508)
4mg/2mL (PL 04543/0507)
INDIA
Evaluation by PEC:
Lahore
☐ Importer
540) Dated: 08/09/2021
540) Dated: 08/09/2021
☐ Export sale
The proposed proprietary name / brand name Genset 4mg/2ml Injection
8mg/4mL (PL 04543/0508)
4mg/2mL (PL 04543/0507)
INDIA
Evaluation by PEC:
Lahore
☐ Importer
540) Dated: 08/09/2021
540) Dated: 08/09/2021
☐ Export sale
The proposed proprietary name / brand name Genset 4mg/5ml Syrup
Pharmaceutical form of applied drug Oral liquid
INDIA
Evaluation by PEC:
Brand Name Stawia Syrup 4mg/5ml
Rawat, Pakistan
Name, address of Manufacturing site. M/s Bio Mark Pharmaceuticals. Plot No. 527, Sundar
Industrial Estate,Lahore
☐ Importer
GMP status of the manufacturer Firm has submitted copy of GMP certificate dated 26-
02-2020 of M/s Bio-Mark based upon Evaluation
conducted on 13-02-2020
dated 12-06-2017 specifying Oral syrup (General)
section.
☐ Export sale
The proposed proprietary name / brand name Ondcare 4mg/5ml Syrup
Pharmaceutical form of applied drug Clear to straw coloured syrup filled in amber coloured
PET bottle
Name and address of API manufacturer. Anugraha Chemicals, No. D-47 to D-50, C-62 & C-
63, KSS DC Industrial Estate, Doddaballapur,
Banglore, Karnata India.
Evaluation by PEC:
The applied product to be manufactured by M/s Bio Mark Pharmaceuticals. Plot No. 527, Sundar Industrial
Estate, Lahore has already been approved by Registration Board in its 316th meeting based on the data of
in 316th meeting are as follows:
Applicant firm M/s Islam Pharmaceuticals. 7 km, Pasrur Road, Sialkot
Manufacturer firm M/s Bio Mark Pharmaceuticals.

Brand Name Aptron Syrup 4mg/5ml
243. Name, address of Applicant / Marketing M/s Onyx Pharmaceuticals. 30-A, Industrial Estate
Authorization Holder Mansehra
☐ Importer
section.
☐ Export sale
The proposed proprietary name / brand name Sonyx 4mg/5ml Syrup
PET bottle
Evaluation by PEC:

☐ Importer
section.
☐ Export sale
The proposed proprietary name / brand name Onset Syrup 4mg/5ml
PET bottle
Evaluation by PEC:

 M/s Pharmedic has already been granted approval for applied formulation by way of contract
manufacturing from M/s Shrooq Pharmaceuticals (Pvt.) Ltd in 326th meeting of Registration Board.
Pantoprazole Sodium
Sheikhupura.
15th January, 2020
☐ Export sale
submitted 02-2023
The proposed proprietary name / brand name Pantac 40mg IV Injection
Strength / concentration of drug of Active Each Lyophillized Vial Contains:
Pharmaceutical ingredient (API) per unit Pantoprazole Sodium Eq. to Pantoprazole…….40mg
The status in reference regulatory authorities Pantoprazole sodium 40mg IV Injection of M/s
Sandoz Inc (USFDA approved)
For generic drugs (me-too status) NEEGE 40mg Injection of M/s Sami Pharma (Reg #
057832)
Name and address of API manufacturer. M/s Vision pharmaceuticals (pvt) Ltd., Plot no. 22-23,
Industrial Triangle, Kahuta Road, Islamabad.
Evaluation by PEC:
Brand Name PANTO 40mg IV Injection
The composition of applied formulation shall not mention “Lyophilized vial”.

Sheikhupura.
15th January, 2020
☐ Export sale
submitted 11-2022
The proposed proprietary name / brand name Gatolin 40mg IV Injection
Strength / concentration of drug of Active Each Lyophillized Vial Contains:
Pharmaceutical ingredient (API) per unit Pantoprazole Sodium Eq. to Pantoprazole…….40mg
The status in reference regulatory authorities Pantoprazole sodium 40mg IV Injection of M/s
Sandoz Inc (USFDA approved)
For generic drugs (me-too status) NEEGE 40mg Injection of M/s Sami Pharma (Reg #
057832)
Industrial Triangle, Kahuta Road, Islamabad.
Evaluation by PEC:
Brand Name PANTO 40mg IV Injection
The composition of applied formulation shall not mention “Lyophilized vial”.

Paracetamol
247. Name, address of Applicant / Marketing M/s Well & Well Pharma Pvt Ltd.
Authorization Holder Plot 7, Street S-8, RCCI, National Industrial Zone,
Rawat, Islamabad
Islamabad
conducted in 26-01-2018 declares Liquid Injectable
Vial section.
☐ Export sale
submitted 11-2022
The proposed proprietary name / brand name Piractim 1gm Infusion
Pharmaceutical ingredient (API) per unit Paracetamol …1000mg
Pharmaceutical form of applied drug Clear and colorless liquid filled in clear and
colorless glass vials.
Pharmacotherapeutic Group of (API) Analgesics and antipyretics
Reference to Finished product specifications Innovator Specifications
The status in reference regulatory authorities Acetaminophen 1g/100ml Infusion by Baxter
Healthcare Coporation (United states), FDA
Approved.
For generic drugs (me-too status) Provas Infusion by Sami Pharmaceuticals (Pvt)
Ltd. Reg No: 053223
Name and address of API manufacturer. M/s HEBEI JIHENG PHARMACEUTICAL
CO., LTD. No.1 Weiwu Street Industrial Park
Hengshui City, Hebei Province, 053000 China.
Evaluation by PEC:
Kahuta Road, Islamabad have already been approved by Registration Board in its 322nd meeting based on
Applicant firm M/s Reliance Pharma Plot # 8, Street No. S-8, RCCI,
Industrial Estate, Rawat Islamabad-Pakistan
Brand Name Relimol Infusion
Piperacillin Sodium/Tazobactam Sodium

Road, Lahore
Name, address of Manufacturing site. M/s Fleming Pharmaceutical.
23- Km Lahore- Sheikhupura Road, Lahore.
☐ Importer
GMP status of the manufacturer New license granted on 13/09/2021.
Following sections have been granted by CLB:
Oral dry powder for
suspension(penicillin),Capsule(penicillin),tablet
(penicillin),Dry powder Injectable (penicillin),Dry
powder injectable (Carbapenem
Evidence of approval of manufacturing facility New license granted on 13/09/2021.
Oral dry powder for
☐ Export sale
The proposed proprietary name / brand name Tazopin 4.5gm Injection
Pharmaceutical ingredient (API) per unit Piperacillin as sodium………4g
Tazobactam as sodium …….0.5g
Pharmaceutical form of applied drug White to off white powder filled in clear glass vials
Pharmacotherapeutic Group of (API) Penicillin antibiotic
The status in reference regulatory authorities Piperacillin and tazobactam Injection (USFDA
Approved)
For generic drugs (me-too status) Tazop Injection of Global Pharmaceuticals
Name and address of API manufacturer. Shandong Anxin Pharmaceutical Co. Limited.
Address: 106878 Wenliang RdDongjua Town
Licheng District, Jinan, Shandong, 25105, China.
Evaluation by PEC:
The applied product to be manufactured by M/s Fleming Pharmaceutical 23- Km Lahore- Sheikhupura
Road, Lahore.has already been approved by Registration Board in its 321st meeting based on the data of
in 321st meeting are as follows:
Applicant firm M/s Fleming Pharmaceutical. 23- Km Lahore- Sheikhupura

Road, Lahore.
Manufacturer firm M/s Fleming Pharmaceutical. 23- Km Lahore- Sheikhupura
Road, Lahore.
Brand Name Fletazo Injection 4.5g Injection
Road, Lahore
Name, address of Manufacturing site. M/s Fleming Pharmaceutical.
23- Km Lahore- Sheikhupura Road, Lahore.
☐ Importer
GMP status of the manufacturer New license granted on 13/09/2021.
Oral dry powder for
Evidence of approval of manufacturing facility New license granted on 13/09/2021.
Oral dry powder for
☐ Export sale
The proposed proprietary name / brand name Tazopin 2.25gm Injection
trength / concentration of drug of Active Each vial contains:
Approved)
Address: 106878 Wenliang RdDongjua Town
Licheng District, Jinan, Shandong, 25105, China.
Evaluation by PEC:
The applied product to be manufactured by M/s Fleming Pharmaceutical 23- Km Lahore- Sheikhupura
Road, Lahore.has already been approved by Registration Board in its 321st meeting based on the data of
in 321st meeting are as follows:
Applicant firm M/s Fleming Pharmaceutical. 23- Km Lahore- Sheikhupura

Road, Lahore.
Manufacturer firm M/s Fleming Pharmaceutical. 23- Km Lahore- Sheikhupura
Road, Lahore.
Brand Name Fletazo Injection 4.5g Injection
250. Name, address of Applicant / Marketing M/s Fresh Pharmaceuticals.
Authorization Holder Plot No. 7, Street No. S-6, National Industrial Zone,
Rawat, Islamabad
Islamabad
☐ Importer
GMP status of the manufacturer Global pharmaceuticals: Firm has submitted copy of
GMP certificate dated 04-01-2022. The certificate was
issued based on the inspection dated 03-01-2022. The
certificate specifies dry powder injection penicillin
section.
dry powder injection penicillin section.
☐ Export sale
The proposed proprietary name / brand name Feribac 4.5gm IV Injection
Approved)
Name and address of API manufacturer. M/s Nectar Lifesciences Ltd., (Unit No. 1) village
saidpura Tehsil Derabassi District Sahibzada Ajit
Singh Nagar Punjab India.
Evaluation by PEC:
Triangle, Kahuta Road, Islamabad, Pakistan has already been approved by Registration Board in its 316 th
Applicant firm M/s Benson Pharmaceuticals Plot No. 3, Main Road, National
Industrial Zone, RCCI, Rawat.
Manufacturer firm M/s Global Pharmaceuticals Pvt Ltd Plot # 204-205, Industrial
Triangle, Kahuta Road, Islamabad
Brand Name PIPRABEN Injection 4.5g Injection
Road, Lahore
☐ Importer
The certificate specifies dry powder injection
penicillin section.
dry powder injection penicillin section..
☐ Export sale
The proposed proprietary name / brand name Tazip 4.5gm Injection
Approved)
Name and address of API manufacturer. M/s Sterile India Pvt Ltd. Plot No. 100& 118-G,
Phase-IV, Sector-56, HSIIDC, Industrial Estate
Kundli District Sonepat Haryana India.
Evaluation by PEC:
Road, Thokar Niaz Baig, Multan Road, Lahore has already been approved by Registration Board in its
321st meeting based on the data of same batches of drug product as submitted in the instant case. The details
of the already approved product in 321st meeting are as follows:
Applicant firm M/s English Pharmaceuticals Industries. Link Kattar Bund

Manufacturer firm M/s Horizon Healthcare (Pvt) Ltd. Plot No.35-A, Small
Industrial Estate, Taxila
Brand Name ARDCIL Injection 4.5g Injection
Road, Lahore
☐ Importer
penicillin section.
☐ Export sale
The proposed proprietary name / brand name Tazip 2.25gm Injection
Approved)
Evaluation by PEC:
The applied product to be manufactured by M/s English Pharmaceuticals Industries. Link Kattar Bund Road,
Thokar Niaz Baig, Multan Road, Lahore has already been approved by Registration Board in its 321st meeting
approved product in 321st meeting are as follows:
Applicant firm M/s Horizon Healthcare (Pvt) Ltd. Plot No.35-A, Small

Pakistan
Name, address of Manufacturing site. M/s. Stallion Pharmaceuticals (Pvt.) Ltd. 581-Sundar
Industrial Estate, Lahore Pakistan
☐ Importer
GMP status of the manufacturer Stallion Pharmaceuticals: Firm has submitted GMP
certificate issued on the basis of inspection dated 22-
09-2020.
Evidence of approval of manufacturing facility GMP certificate issued on the basis of inspection dated
22-09-2020 for M/s Stallion Pharma specifying dry
powder injection Vial (Penicillin) section.
☐ Export sale
The proposed proprietary name / brand name Tazocal 4.5gm Injection
Approved)
Name and address of API manufacturer. M/s Shandong (Previously Qilu) Anxin
Pharmaceutical Co., Ltd. 10678 Wenliang Road,
Dongjia Town, Licheng District, Jinan,
Shandong, China
Evaluation by PEC:
The applied product to be manufactured by M/s. Stallion Pharmaceuticals (Pvt.) Ltd. 581-Sundar Industrial
Estate, Lahore Pakistan has already been approved by Registration Board in its 308th meeting based on the
Applicant firm M/s Healthtek (Pvt.) Limited. Plot No. 14, Sector 19, Korangi
Industrial Area Karachi
Manufacturer firm M/s. Stallion Pharmaceuticals (Pvt.) Ltd. 581-Sundar Industrial
Estate, Lahore Pakistan
Brand Name PITZO Injection 4.5g Injection
Pakistan
☐ Importer
09-2020.
☐ Export sale
The proposed proprietary name / brand name Tazocal 2.25gm Injection
Approved)
Shandong, China
Evaluation by PEC:
product in 321st meeting are as follows:
Brand Name PITZO Injection 2.25 Injection
☐ Importer
09-2020.
☐ Export sale
The proposed proprietary name / brand name TazoBiz 4.5g Injection
Approved)
Shandong, China
Evaluation by PEC:
256. Name, address of Applicant / Marketing M/s Fedro Pharmaceuticals Lab Pvt Limited.
Authorization Holder 149-Industrial Estate, Hayatabad, Peshawar
☐ Importer
09-2020.
☐ Export sale
The proposed proprietary name / brand name Tazo-P 4.5gm Injection
Approved)
Shandong, China
Evaluation by PEC:
257. Name, address of Applicant / Marketing M/s Fedro Pharmaceuticals Lab Pvt Limited.
Authorization Holder 149-Industrial Estate, Hayatabad, Peshawar
☐ Importer
09-2020.
☐ Export sale
The proposed proprietary name / brand name Tazo-P 2.25gm Injection
Approved)
Shandong, China
Evaluation by PEC:
product in 321st meeting are as follows:
Brand Name PITZO Injection 2.25 Injection
Name, address of Applicant / Marketing M/s Avant Pharmaceuticals.
258. Authorization Holder M-028 H.I.T.E, Lasbela, Balochistan
Road, Lahore
☐ Importer
penicillin section.
☐ Export sale
The proposed proprietary name / brand name Tazobac 4.5gm Injection
Approved)
Evaluation by PEC:
Road, Thokar Niaz Baig, Multan Road, Lahore has already been approved by Registration Board in its
321st meeting based on the data of same batches of drug product as submitted in the instant case. The details
of the already approved product in 321st meeting are as follows:
Applicant firm M/s English Pharmaceuticals Industries. Link Kattar Bund

Manufacturer firm M/s Horizon Healthcare (Pvt) Ltd. Plot No.35-A, Small
Road, Lahore
☐ Importer
penicillin section.
☐ Export sale
The proposed proprietary name / brand name Tazobac 2.25gm Injection
Approved)
Evaluation by PEC:
The applied product to be manufactured by M/s English Pharmaceuticals Industries. Link Kattar Bund Road,
Thokar Niaz Baig, Multan Road, Lahore has already been approved by Registration Board in its 321st meeting
approved product in 321st meeting are as follows:
Applicant firm M/s Horizon Healthcare (Pvt) Ltd. Plot No.35-A, Small

Islamabad
☐ Importer
section.
☐ Export sale
The proposed proprietary name / brand name P-Taz 4.5gm IV Injection
Approved)
Evaluation by PEC:
Triangle, Kahuta Road, Islamabad, Pakistan has already been approved by Registration Board in its 316th
Islamabad
☐ Importer
section.
☐ Export sale
The proposed proprietary name / brand name P-Taz 2.25gm IV Injection
Approved)
Evaluation by PEC:
Authorization Holder Ltd. 16 Km, Multan Road, Lahore
Islamabad
☐ Importer
section.
☐ Export sale
The proposed proprietary name / brand name Tazo-X 4.5gm Injection
Approved)
Evaluation by PEC:
Authorization Holder Ltd. 16 Km, Multan Road, Lahore
Islamabad
☐ Importer
section.
☐ Export sale
The proposed proprietary name / brand name Tazo-X 2.25gm Injection
Approved)
Evaluation by PEC:
264. Name, address of Applicant / Marketing M/s Barrett Hodgson Pakistan Pvt Ltd.
Authorization Holder F/423, SITE, Karachi
Islamabad
☐ Importer
section.
☐ Export sale
The proposed proprietary name / brand name Synibac 4.5gm Injection
The status in reference regulatory authorities Piperacillin and Tazobactam Injection (USFDA
Approved)
Evaluation by PEC:
265. Name, address of Applicant / Marketing M/s Barrett Hodgson Pakistan Pvt Ltd.
Authorization Holder F/423, SITE, Karachi
Islamabad
☐ Importer
section.
☐ Export sale
The proposed proprietary name / brand name Synibac 2.25gm Injection
Approved)
Evaluation by PEC:
Islamabad
☐ Importer
section.
☐ Export sale
The proposed proprietary name / brand name Tazolin 4.5gm Injection
Approved)
Evaluation by PEC:
Islamabad
☐ Importer
section.
☐ Export sale
The proposed proprietary name / brand name Tazopep 2.25gm IV Injection
Approved)
Evaluation by PEC:
Islamabad
☐ Importer
section.
☐ Export sale
Approved)
Evaluation by PEC:
Islamabad
☐ Importer
section.
☐ Export sale
Approved)
Evaluation by PEC:
Name, address of Applicant / Marketing M/s Akhai Pharmaceuticals Pvt Ltd.
270. Authorization Holder Plot # A-248 & A-256 to A-259, H.I.T.E. Lasbela
Islamabad
☐ Importer
section.
☐ Export sale
The proposed proprietary name / brand name Piptazo 4.5gm IV Injection
Approved)
Evaluation by PEC:
Islamabad
☐ Importer
section.
☐ Export sale
The proposed proprietary name / brand name Piptazo 2.25gm IV Injection
Approved)
Evaluation by PEC:
Racecadotril
Taxila Pakistan
Name, address of Manufacturing site. M/s WnsFeild Pharmaceutical Plot No. 122 Phase 5,
Industrial Estate Hattar Haripur Kpk Pakistan.
GMP status of the manufacturer GMP certificate based on inspection dated
27.09.2019 granted on 14.10.2019
Evidence of approval of manufacturing facility Sachet (General) section was approved on
12.02.2013
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Resko 30mg Sachet
Strength / concentration of drug of Active Each sachet contains: -
Pharmaceutical ingredient (API) per unit Racecadotril ……………30mg
Pharmaceutical form of applied drug Granules for oral suspension
Pharmacotherapeutic Group of (API) Enkephalinase Inhibitor
Reference to Finished product specifications Manufacturer’s specification
The status in reference regulatory authorities Hidrasec 30 mg, Granules for oral suspension by
SOPHARTEX 21 rue de Pressoir 28500 Vernouillet
France, MHRA.
For generic drugs (me-too status) Hidrasec 30mg Granules for Oral Suspension
by Abbott Laboratories (Pakistan) Limited.
Name and address of API manufacturer. Symed Labs Ltd. India, Unit II, Plot No 25/B, Phase
III, I.D.A, Jeedimetla, Hyderabad, Telangana, India.
Evaluation by PEC:
The applied product to be manufactured by M/s WnsFeild Pharmaceutical Plot No. 122 Phase 5, Industrial
Estate Hattar Haripur Kpk Pakistan have already been approved by Registration Board in its 324th meeting
Applicant firm M/s WnsFeild Pharmaceutical Plot No. 122 Phase 5, Industrial
Estate Hattar Haripur Kpk Pakistan.
Manufacturer firm M/s WnsFeild Pharmaceutical Plot No. 122 Phase 5, Industrial
Brand Name Raceka 30mg sachet
Taxila Pakistan
27.09.2019 granted on 14.10.2019
12.02.2013
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Resko 10mg Sachet
France, MHRA.
Evaluation by PEC:
27.09.2019 granted on 14.10.2019
12.02.2013
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Racefo 30mg Sachet
France, MHRA.
Evaluation by PEC:
27.09.2019 granted on 14.10.2019
12.02.2013
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Racefo 10mg Sachet
France, MHRA.
Evaluation by PEC:
Cantt.
27.09.2019 granted on 14.10.2019
12.02.2013
☐ Export sale
submitted
The proposed proprietary name / brand name Riseka 30mg Sachet
France, MHRA.
Evaluation by PEC:
Cantt.
27.09.2019 granted on 14.10.2019
12.02.2013
☐ Export sale
submitted
The proposed proprietary name / brand name Riseka 10mg Sachet
France, MHRA.
Evaluation by PEC:
Hattar, Pakistan
27.09.2019 granted on 14.10.2019
12.02.2013
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Raceba 30mg Sachet
France, MHRA.
Evaluation by PEC:
Hattar, Pakistan
27.09.2019 granted on 14.10.2019
12.02.2013
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Raceba 10mg Sachet
France, MHRA.
Evaluation by PEC:
Lahore
27.09.2019 granted on 14.10.2019
12.02.2013
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Raseka 30mg Sachet
France, MHRA.
Evaluation by PEC:
Lahore
27.09.2019 granted on 14.10.2019
12.02.2013
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Raseka 10mg Sachet
France, MHRA.
Reg. No. 087082
Evaluation by PEC:
Hattar, KPK
27.09.2019 granted on 14.10.2019
12.02.2013
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Raceka 30mg Sachet
France, MHRA.
Evaluation by PEC:
Hattar, KPK
27.09.2019 granted on 14.10.2019
12.02.2013
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Raceka 10mg Sachet
France, MHRA.
Reg. No. 087082
Evaluation by PEC:
27.09.2019 granted on 14.10.2019
12.02.2013
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Racode 30mg Sachet
France, MHRA.
Evaluation by PEC:
27.09.2019 granted on 14.10.2019
12.02.2013
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Racode 10mg Sachet
France, MHRA.
Reg. No. 087082
Evaluation by PEC:
286. Name, address of Applicant / Marketing M/s Aspin Pharma Pvt Ltd.
Authorization Holder Plot No. 10 & 25, Sector 20, 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, Karachi –
74900, Pakistan
Valid till: 17/12/2023.
Sachet section (General) regularized on 21.07.2020
Evidence of approval of manufacturing facility Sachet section (General) regularized on 21.07.2020
☐ Export sale
submitted 12-2022
The proposed proprietary name / brand name Roctril 10mg Sachet
France, MHRA.
Reg. No. 087082
Name and address of API manufacturer. Shandong Qidu Pharmaceutical Co., Ltd. No.17,
Hongda Road, Linzi District, Zibo City, Shandong,
province, China.
Evaluation by PEC:
The applied product to be manufactured by M/s Indus Pharma (Pvt.) Ltd. Plots No. 26-27 & 63-67, sector-
27 Korangi Industrial Area, Karachi – 74900, Pakistan have already been approved by Registration Board
in its 326th meeting based on the data of same batches of drug product as submitted in the instant case. The
Applicant firm M/s Indus Pharma (Pvt.) Ltd. Plots No. 26-27 & 63-67, sector-
27 Korangi Industrial Area, Karachi – 74900, Pakistan
Manufacturer firm M/s Indus Pharma (Pvt.) Ltd. Plots No. 26-27 & 63-67, sector-
27 Korangi Industrial Area, Karachi – 74900, Pakistan
Brand Name Raceca 10mg Granules for Oral Suspension
Solifenacin Succinate/Tamsulosin HCl

287. Name, address of Applicant / Marketing M/s CCL Pharmaceuticals Pvt Ltd.
Authorization Holder 62 Industrial Estate,Kot Lakhpat,Lahore
☐ Export sale
submitted 11-2022
The proposed proprietary name / brand name Maxflow-S 6/0.4 mg Tablet
Strength / concentration of drug of Active Each Modified Release Tablet Contains:
Pharmaceutical ingredient (API) per unit Solifenacin Succinate(Immediate
Release…….6.0mg Tamsulosin HCl (modified
Release)………….0.4mg
Pharmaceutical form of applied drug film coated tablet.
Pharmacotherapeutic Group of (API) Solifenacin Succinate: Urologicals, Drugs for
urinary frequency and incontinence
Tamsulosin HCl: Adrenergic ɑ 1-receptor
antagonist
Reference to Finished product specifications As per innovator Specifications
Name and address of API manufacturer. Solifenacin Succinate:
M/s Optimus Drugs (Pvt.) Limited. Survey No.
239 & 240, Dothigudan (V), Pochampally (M),
Yadadri, BhuvanagriIndia
Tamsulosin HCl:
M/s Symed Labs (Pvt) Ltd. Survey No,
353, Domadugu (Village), Jinnaram
(Mandal),Medak (Dist) ,Telangana, INDIA.
Evaluation by PEC:
Brand Name Sinzon-S tablet 6.0/0.4mg
 M/s CCL Pharmceuticals had already applied same formulation for contract manufacturing from
Ms Gloal Pharmcueticals, which had been deferred by Registration Board.
Tapentadol
Taxila Pakistan
peshawer
submitted 07-2023
The proposed proprietary name / brand name Typend 75mg Tablet
Pharmaceutical ingredient (API) per unit Tapentadol as HCl……75mg
Pharmacotherapeutic Group of (API) Analgesic, opioids
For generic drugs (me-too status) Tapento tablet by M/s Sami Pharmaceuticals, Reg.
No. 093064
Name and address of API manufacturer. M/s Precise Chemipharma Pvt Limited, C384, TTC
Industrial area, MIDC, Pawne village, Nawi Mumbai,
India
Evaluation by PEC:
Industrial Hatta have already been approved by Registration Board in its 324th meeting based on the data
are as follows:

Industrial Hatta
Industrial Hatta
Brand Name Tapentawel 75mg tablet
peshawer
submitted 07-2023
The proposed proprietary name / brand name Tepind 75mg Tablet
No. 093064
India
Evaluation by PEC:
are as follows:

Industrial Hatta
Industrial Hatta
Hattar, Pakistan
peshawer
submitted 07-2023
The proposed proprietary name / brand name Tepinda 75mg Tablet
No. 093064
India
Evaluation by PEC:
are as follows:

Industrial Hatta
Industrial Hatta
Lahore
peshawer
submitted 07-2023
The proposed proprietary name / brand name Tapent 75mg Tablet
No. 093064
India
Evaluation by PEC:
are as follows:

Industrial Hatta
Industrial Hatta
Estate, Hattar
peshawer
Dy. No. and date of submission & Details of fee Dy.No 17694 dated 14-07-2023
submitted
The proposed proprietary name / brand name Tenpand 75mg Tablet
No. 093064
India
Evaluation by PEC:
are as follows:

Industrial Hatta
Industrial Hatta
Hattar, KPK
peshawer
submitted 07-2023
The proposed proprietary name / brand name Typint 75mg Tablet
No. 093064
India
Evaluation by PEC:
are as follows:

Industrial Hatta
Industrial Hatta
Tenofovir alafenamide
Hattar, Pakistan
peshawer
peshawer declares tablet general section availability
submitted 07-2023
The proposed proprietary name / brand name Tenofa 25mg Tablet
Pharmaceutical ingredient (API) per unit Tenofovir Alafenamide Fumarate Eq. to Tenofovir
Alafenamide…25mg
Pharmacotherapeutic Group of (API) Antiviral for systemic use, nucleoside and nucleotide
reverse transcriptase inhibitors.
The status in reference regulatory authorities Vemlidy Tablet 25mg by Gilead Sciences Ltd.
U.S.A.., USFDA Approved.
For generic drugs (me-too status) Tenofomide Tablet 25mg by M/s. Getz pharma ., Reg.
No. 093109
Name and address of API manufacturer. Shandong Haiyo Freda Pharmaceutical Co Ltd
Address: 666 Bianhai West Road Linshu West
Industrial Zone, Shandong Province.
Evaluation by PEC:
are as follows:

Industrial Hatta
Industrial Hatta
Brand Name Teno 25mg Tablet
peshawer
submitted 07-2023
The proposed proprietary name / brand name Tenfold 25mg Tablet
Alafenamide…25mg
No. 093109
Evaluation by PEC:
are as follows:

Industrial Hatta
Industrial Hatta
Lahore
peshawer
submitted 07-2023
The proposed proprietary name / brand name Tenfova 25mg Tablet
Alafenamide…25mg
No. 093109
Evaluation by PEC:
are as follows:

Industrial Hatta
Industrial Hatta
Terbinafine HCl
297. Name, address of Applicant / Marketing M/s Nicholas Pharmaceuticals. Plot # 34, St. # SS-
Authorization Holder 02, National Industrial Zone, Rawat, Islamabad
Name, address of Manufacturing site. M/s Caliph Pharmaceuticals (Pvt) Ltd. Plot No
17, Special Industrial Zone (EPZ), Risalpur
GMP status of the manufacturer GMP certificate granted on basis of inspection
conducted on 02-03-2021.
Evidence of approval of manufacturing facility GMP certificate granted on basis of inspection
conducted on 02-03-2021 declares availability of
☐ Export sale
submitted 02-2023
The proposed proprietary name / brand name Terviza 250mg Tablet
Strength / concentration of drug of Active Each Tablet Contains:
Pharmaceutical ingredient (API) per unit Terbinafine as HCl…250mg
Pharmacotherapeutic Group of (API) Antifungals for systemic use
Reference to Finished product specifications USP specification
The status in reference regulatory authorities Terbinafine 250mg Tablets by M/s Dr. Reddy’s
Laboratories (UK) Ltd, MHRA approved
For generic drugs (me-too status) Lamisil 250mg Tablet by M/s Novartis Pharma
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.
Evaluation by PEC:
The applied product to be manufactured by M/s Caliph Pharmaceuticals (Pvt) Ltd. Plot No 17, Special
Industrial Zone (EPZ), Risalpur have already been approved by Registration Board in its 329th meeting
Applicant firm M/s Caliph Pharmaceuticals (Pvt) Ltd. Plot No 17,

Special Industrial Zone (EPZ), Risalpur
Manufacturer firm M/s Caliph Pharmaceuticals (Pvt) Ltd. Plot No 17,
Brand Name Lamical 250 Tablet
conducted on 02-03-2021 declares availability of
☐ Export sale
submitted 02-2023
The proposed proprietary name / brand name Terviza 125mg Tablet
Pharmaceutical ingredient (API) per unit Terbinafine as HCl…125mg
Pharmacotherapeutic Group of (API) Antifungals for systemic use
Reference to Finished product specifications USP specification
The status in reference regulatory authorities Terbinafine 125mg Tablets by M/s Dr. Reddy’s
Laboratories (UK) Ltd, MHRA approved
Evaluation by PEC:
Industrial Zone (EPZ), Risalpur have already been approved by Registration Board in its 329th meeting

Brand Name Lamical 125mg tablet
Ticagrelor
Pakistan
submitted 07-2023
The proposed proprietary name / brand name Ticrole 90mg Tablet
Strength / concentration of drug of Active Each Film Coated Ttablet Contains:
Pharmaceutical ingredient (API) per unit Ticagrelor…90mg
Pharmacotherapeutic Group of (API) Platelet aggregation inhibitors excl. heparin.
Reference to Finished product specifications Innovator’s specifications.
The status in reference regulatory authorities Brilinta 90 mg film coated tablets, USFDA approved.
For generic drugs (me-too status) Anplag 90mg, PharmEvo (Pvt.) Ltd.,
Name and address of API manufacturer. M/s Nantong Chanyoo Pharmatech Co., Ltd., No. 2
Tonghai Si Road, Rudong Coastal Economic
Development Zone, Nantong, Jiangsu Province
226407, China.
Evaluation by PEC:
Industrial Estate, Lahore have already been approved by Registration Board in its 321st meeting based on
Brand Name Ticlor 90mg Tablet
Pakistan
submitted 07-2023
The proposed proprietary name / brand name Ticrole 60mg Tablet
Strength / concentration of drug of Active Each Film Coated Ttablet Contains:
Pharmaceutical ingredient (API) per unit Ticagrelor…60mg
Pharmacotherapeutic Group of (API) Platelet aggregation inhibitors excl. heparin.
Reference to Finished product specifications Innovator’s specifications.
The status in reference regulatory authorities Brilinta 60 mg film coated tablets, USFDA approved.
For generic drugs (me-too status) Anplag 60mg, PharmEvo (Pvt.) Ltd., Reg. No.093105.
Name and address of API manufacturer. M/s Nantong Chanyoo Pharmatech Co., Ltd., No. 2
Tonghai Si Road, Rudong Coastal Economic
Development Zone, Nantong, Jiangsu Province
226407, China.
Evaluation by PEC:
Brand Name Ticlor 90mg Tablet
Vancomycin HCl
29/04/2022.
(General)
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Myco 1gm Injection
Pharmaceutical ingredient (API) per unit Vancomycin Hydrochloride USP equivalent to
Vancomycin …….1gm
Pharmaceutical form of applied drug Dry Powder injection
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. 1gm Injection by M/s Nabiqasim
Industries (Pvt.) Ltd, Reg. No. 070682
Evaluation by PEC:
Lahorehave already been approved by Registration Board in its 323rd meeting based on the data of same
follows:
Lahore
Lahore
Brand Name Myocin 1gm Dry Powder vial I.V
29/04/2022.
(General)
☐ Export sale
submitted 07-2023
The proposed proprietary name / brand name Myco 500mg Injection
Pharmaceutical ingredient (API) per unit Vancomycin Hydrochloride equivalent to
Vancomycin …….500mg
( as lyophilized powder for injection)
Pharmaceutical form of applied drug Dry Powder injection
For generic drugs (me-too status) Vanbact I.V. 500mg Injection by M/s Nabiqasim
Evaluation by PEC:
follows:
Lahore
Lahore
Brand Name Myocin 500mg Dry Powder vial I.V
303. Name, address of Applicant / Marketing M/s Surge Laboratories Pvt Ltd.
Authorization Holder 10 km, Faisalabad Road, Bikhi, District
Sheikhupura
Name, address of Manufacturing site. M/s Nabiqasim Industries Pvt Ltd. 17/24, Korangi
Industrial Area, Karachi, Pakistan
GMP status of the manufacturer GMP certificate issued on 06-10-2020
Evidence of approval of manufacturing facility GMP certificate issued on 06-10-2020 declared
availability of Lyophilized Injectable general section.
☐ Export sale
submitted 04-2023 & Rs.45,000/- dated 19-05-2023
The proposed proprietary name / brand name Vancova 1gm IV Injection
Vancomycin …….1gm
For generic drugs (me-too status) Vanbact I.V. 1gm Injection by M/s Nabiqasim
Evaluation by PEC:
The applied product to be manufactured by M/s Nabiqasim Industries Pvt Ltd. 17/24, Korangi Industrial
Area, Karachi, Pakistan have already been approved by Registration Board in its 322 nd meeting based on
Applicant firm M/s Indus Pharma (Pvt.) Ltd. Plots No. 26-27 & 63-67,
sector-27 Korangi Industrial Area, Karachi – 74900,
Pakistan
Manufacturer firm M/s Nabiqasim Industries Pvt Ltd. 17/24, Korangi Industrial
Area, Karachi, Pakistan
Brand Name Vanco 1gm Injection
304. Name, address of Applicant / Marketing M/s Surge Laboratories Pvt Ltd.
Authorization Holder 10 km, Faisalabad Road, Bikhi, District
Sheikhupura
Name, address of Manufacturing site. M/s Nabiqasim Industries Pvt Ltd. 17/24, Korangi
Industrial Area, Karachi, Pakistan
GMP status of the manufacturer GMP certificate issued on 06-10-2020
Evidence of approval of manufacturing facility GMP certificate issued on 06-10-2020 declared
availability of Lyophilized Injectable general section.
☐ Export sale
submitted 04-2023 & Rs.45,000/- dated 19-05-2023
The proposed proprietary name / brand name Vancova 500mg IV Injection
Vancomycin …….500mg
For generic drugs (me-too status) Vanbact I.V. 500mg Injection by M/s Nabiqasim
Evaluation by PEC:
The applied product to be manufactured by M/s Nabiqasim Industries Pvt Ltd. 17/24, Korangi Industrial
Area, Karachi, Pakistan have already been approved by Registration Board in its 322 nd meeting based on
Applicant firm M/s Indus Pharma (Pvt.) Ltd. Plots No. 26-27 & 63-67,
sector-27 Korangi Industrial Area, Karachi – 74900,
Pakistan
Manufacturer firm M/s Nabiqasim Industries Pvt Ltd. 17/24, Korangi Industrial
Area, Karachi, Pakistan
Brand Name Vanco 500mg Injection
Vonoprazan Fumarate
Rawat, Pakistan
Name, address of Manufacturing site. M/s Weather Folds Pharmaceuticals.
Plot # 69, Phase-II, Industrial Estate, Hattar
GMP status of the manufacturer The firm has submitted copy of panel
inspection report dated 20-02-2019 in which the
panel recommended grant of GMP certificate.
Evidence of approval of manufacturing facility Firm has submitted copy of change of section letter
in which the change of Tablet (psychotropic) section
to Tablet (General) section was recommended by
CLB in its 222nd meeting.
☐ Export sale
The proposed proprietary name / brand name Vonocare 20mg Tablet
Pharmaceutical ingredient (API) per unit Vonoprazan as Fumarate…20mg
Pharmaceutical form of applied drug Film coated tablet.
Pharmacotherapeutic Group of (API) Potassium-Competitive Acid Blokers (PCAB)
Reference to Finished product specifications Innovator’s specification
The status in reference regulatory authorities Takecab 10mg tablet by M/s Takeda
pharmaceutical company Ltd. PMDA Japan
approved
For generic drugs (me-too status) Vonseca 10mg tablet by M/s Tabros, Karachi
Name and address of API manufacturer. Ami Life Sciences Pvt Ltd. Block No. 82/B, ECP
Road, AT & Post. Karakhadi, Tal-Padra Karakhadi-
391 450 District Vadodara Gujrat State India.
Evaluation by PEC:
The applied product to be manufactured by M/s Weather Folds Pharmaceuticals Plot # 69, Phase-II,
Industrial Estate, Hattar have already been approved by Registration Board in its 322 nd meeting based
on the data of same batches of drug product as submitted in the instant case. The details of the already
Applicant firm M/s Weather Folds Pharmaceuticals Plot # 69, Phase-II,

Industrial Estate, Hattar
Manufacturer firm M/s Weather Folds Pharmaceuticals Plot # 69, Phase-II,
Brand Name Vonozen 20mg Tablet
Rawat, Pakistan
Name, address of Manufacturing site. M/s Weather Folds Pharmaceuticals.
Plot # 69, Phase-II, Industrial Estate, Hattar
inspection report dated 20-02-2019 in which the
panel recommended grant of GMP certificate.
☐ Export sale
The proposed proprietary name / brand name Vonocare 10mg Tablet
approved
Name and address of API manufacturer. Ami Life Sciences Pvt Ltd. Block No. 82/B, ECP
Road, AT & Post. Karakhadi, Tal-Padra Karakhadi-
391 450 District Vadodara Gujrat State India.
Evaluation by PEC:
The applied product to be manufactured by M/s Weather Folds Pharmaceuticals Plot # 69, Phase-II,
Industrial Estate, Hattar have already been approved by Registration Board in its 322 nd meeting based
on the data of same batches of drug product as submitted in the instant case. The details of the already
Applicant firm M/s Weather Folds Pharmaceuticals Plot # 69, Phase-II,

Manufacturer firm M/s Weather Folds Pharmaceuticals Plot # 69, Phase-II,
Brand Name Vonozen 10mg Tablet
conducted on 02-03-2021 declares availability
of Tablet general section.
☐ Export sale
submitted 12-2022
The proposed proprietary name / brand name Vonolet 20mg Tablet
approved
Evaluation by PEC:
Industrial Zone (EPZ), Risalpur have already been approved by Registration Board in its 322nd meeting

Brand Name Vonocal 20mg Tablet
☐ Export sale
submitted 12-2022
The proposed proprietary name / brand name Vonolet 10mg Tablet
approved
Evaluation by PEC:

☐ Export sale
The proposed proprietary name / brand name Vonz 20mg Tablet
approved
Evaluation by PEC:

☐ Export sale
The proposed proprietary name / brand name Vonz 10mg Tablet
approved
Evaluation by PEC:

Name, address of Manufacturing site. M/s Wnsfeild Pharmaceuticals Plot # 122, Block A,
Phase V, Hattar Industrial Estate, Hattar
approved.
☐ Export sale
The proposed proprietary name / brand name Vox 20mg Tablet
approved
,Reg No. 112584
Name and address of API manufacturer. Xianqiang Pharmaceutical Pvt Ltd, No. 6,
industrial Avenue, Conghua, Economical
Development zone, Guangzhou city,
Guangdong province, China
Evaluation by PEC:
The applied product to be manufactured by M/s Wnsfeild Pharmaceuticals Plot # 122, Block A, Phase
V, Hattar Industrial Estate, Hattar have already been approved by Registration Board in its 322 nd
Applicant firm M/s Wnsfeild Pharmaceuticals Plot # 122, Block A, Phase V,

Hattar Industrial Estate, Hattar
Manufacturer firm M/s Wnsfeild Pharmaceuticals Plot # 122, Block A, Phase V,
Brand Name Verozen 20mg Tablet
Name, address of Manufacturing site. M/s Wnsfeild Pharmaceuticals Plot # 122, Block A,
Phase V, Hattar Industrial Estate, Hattar
approved.
☐ Export sale
The proposed proprietary name / brand name Vox 10mg Tablet
approved
For generic drugs (me-too status) Vonseca 10mg tablet by M/s Tabros, Karachi ,
Name and address of API manufacturer. Xianqiang Pharmaceutical Pvt Ltd, No. 6,
industrial Avenue, Conghua, Economical
Development zone, Guangzhou city,
Guangdong province, China
Evaluation by PEC:
The applied product to be manufactured by M/s Wnsfeild Pharmaceuticals Plot # 122, Block A, Phase
V, Hattar Industrial Estate, Hattar have already been approved by Registration Board in its 322 nd
Applicant firm M/s Wnsfeild Pharmaceuticals Plot # 122, Block A, Phase V,

Manufacturer firm M/s Wnsfeild Pharmaceuticals Plot # 122, Block A, Phase V,
Brand Name Verozen 10mg Tablet
Vonoprazan/Aspirin

Taxila Pakistan
Plot # 122, Block A, Phase V, Hattar Industrial
Estate, Hattar
inspection report dated 20-02-2019 in which
the panel recommended grant of GMP
certificate.
☐ Export sale
The proposed proprietary name / brand name Vospin 10/100 mg Tablet
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
The status in reference regulatory authorities Cabpirin 10/100mg tablet by M/s Takeda
Pharmaceutical (Japan)
Name and address of API manufacturer. Vonoprazan:
Guangdong Xianqiang Pharmaceutical Pvt Ltd, No.
6, industrial Avenue, Conghua, Economical
Development zone, Guangzhou city, Guangdong
province, China
Aspirin
JQC (HUAYIN) Pharmaceutical Co, Ltd/
Yuquan Road, Huayin city, Shanxi province,
P.R of China
Evaluation by PEC:
The applied product to be manufactured by M/s WnsFeild Pharmaceutical Plot No. 122 Phase 5,
Industrial Estate Hattar Haripur Kpk Pakistan have already been approved by Registration Board in its
Estate Hattar Haripur Kpk Pakistan
Brand Name Venospa 10/100mg Tablet
Plot # 122, Block A, Phase V, Hattar Industrial
Estate, Hattar
inspection report dated 20-02-2019 in which
the panel recommended grant of GMP
certificate.
in which the change of Tablet (psychotropic)
section to Tablet (General) section was
recommended by CLB in its 222nd meeting.
☐ Export sale
The proposed proprietary name / brand name Vono-AS 10/100 mg Tablet
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
The status in reference regulatory authorities Cabpirin 10/100mg tablet by M/s Takeda
Pharmaceutical (Japan)
Name and address of API manufacturer. Vonoprazan:
Guangdong Xianqiang Pharmaceutical Pvt Ltd, No.
6, industrial Avenue, Conghua, Economical
Development zone, Guangzhou city, Guangdong
province, China
Aspirin
JQC (HUAYIN) Pharmaceutical Co, Ltd/
Yuquan Road, Huayin city, Shanxi province,
P.R of China
Evaluation by PEC:
The applied product to be manufactured by M/s WnsFeild Pharmaceutical Plot No. 122 Phase 5,
Industrial Estate Hattar Haripur Kpk Pakistan have already been approved by Registration Board in its
Brand Name Venospa 10/100mg Tablet
Case no. 02 Registration applications of newly granted DML or New section
(Human)
a. New DML
315. Name, address of Applicant / Marketing M/s Himark Laboratories (Pvt.) Ltd Plot # 37- A,
Authorization Holder Sunder Industrial Estate, Lahore.
Name, address of Manufacturing site. M/s Himark Laboratories (Pvt.) Ltd Plot # 37- A,
Status of the applicant ☒ Manufacturer
☐ Importer
☐ Is involved in none of the above (contract giver)
GMP status of the firm Firm has submitted copy of GMP certificate dated
06-04-2023 based on inspection conducted on 28-03-
2023.
Evidence of approval of manufacturing facility Firm has submitted copy of letter of grant of section
dated 24-03-2015 specifying Tablet (General)
section.
☐ Export sale
Dy. No. and date of submission Dy. No 13182 dated 29-05-2023
Details of fee submitted PKR 30,000/- Dated 11-05-2023
The proposed proprietary name / brand name Sitagmin (50/1000) film coated tablet
Strength / concentration of drug of Active Each Film coated tablet contains:
Pharmaceutical ingredient (API) per unit Sitagliptin (as Phosphate Monohydrate)
……….. 50 mg
Metformin HCl ……………1000 mg
Pharmacotherapeutic Group of (API) Anti-diabetic
Pharmaceutical form of applied drug Light blue color oblong film coated tablet
Proposed Pack size 2 x 7’s
The status in reference regulatory authorities Janumet film coated tablet (50 /1000 mg) (USFDA
Approved)
For generic drugs (me-too status) Treviamet Tab 50mg/1000mg of M/s M/S Getz
Pharma, Karachi (Reg.No. 055443)
Name and address of API manufacturer. Sitagliptin Phosphate Monohydrate Anhui
Haikang Pharmaceutical Co., Ltd.
No21, Huancheng West Road, Daguan
District, Anqing, Anhui 24600, China
Metformin Hydrochloride
Active Fine Chemicals Limited
West Muktarpur, Munshigonj, Bangaladesh
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,
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 drug substance data
related to nomenclature, structure, general properties,
system and stability studies of drug substance.
Stability Studies of Drug Substance Firm has submitted stability study data of 3 batches
(Conditions & duration of Stability studies) 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.
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 Comparative Firm has submitted pharmaceutical equivalence of
Dissolution Profile their product against the innovator’s product Janumet
film coated tablet (50 /1000 mg) manufactured by
MSD,
Firm has submitted CDP results of their product
against the innovator’s product Janumet film coated
tablet (50 /1000 mg) in 3 dissolution medias.
Analytical method validation/verification of Firm has submitted analytical method validation
product study reports for drug substance as well as drug
product.
STABILITY STUDY DATA
Manufacturer of API Sitagliptin Phosphate Monohydrate Anhui Haikang
Pharmaceutical Co., Ltd. No21, Huancheng West Road, Daguan
District, Anqing, Anhui 24600, China Postcode:246000
West Muktarpur, Munshigonj, Bangladesh
API Lot No. Sitagliptin Phosphate Monohydrate B.No 21042602
Metformin Hydrochloride B.No MET 012104013
Description of Pack
Alu-alu Blister
(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. T01 T032 T03

Batch Size 1000 Tablet 1000 Tablet 1000 Tablet
Manufacturing Date 07-2022 07-2022 07-2021
Date of Initiation 28-07-2022 28-07-2022 28-07-2022
No. of Batches 03
☐ Importer
2023.
section.
☐ Export sale
The proposed proprietary name / brand name Sitagmin (50/500) film coated tablet
Pharmaceutical ingredient (API) per unit Sitagliptin (as Phosphate Monohydrate)
……….. 50 mg
Metformin HCl ……………500 mg
Pharmacotherapeutic Group of (API) Anti-diabetic
Pharmaceutical form of applied drug Light blue color oblong film coated tablet
The status in reference regulatory authorities Janumet film coated tablet (50 /500 mg) (USFDA
Approved)
For generic drugs (me-too status) Treviamet Tab 50mg/500mg of M/s M/S Getz
Pharma, Karachi (Reg.No. 055443)
Name and address of API manufacturer. Sitagliptin Phosphate Monohydrate Anhui
Haikang Pharmaceutical Co., Ltd.
No21, Huancheng West Road, Daguan
District, Anqing, Anhui 24600, China
West Muktarpur, Munshigonj, Bangaladesh
drug product.
30°C ± 2°C / 65% ± 5% RH for 24 months.
Dissolution Profile their product against the innovator’s product Janumet
film coated tablet (50 /500 mg) manufactured by
MSD,
against the innovator’s product Janumet film coated
tablet (50 /500 mg) in 3 dissolution medias.
product.
Manufacturer of API Sitagliptin Phosphate Monohydrate Anhui Haikang
Pharmaceutical Co., Ltd. No21, Huancheng West Road, Daguan
District, Anqing, Anhui 24600, China Postcode:246000
Metformin Hydrochloride:
Active Fine Chemicals Limited West Muktarpur, Munshigonj, Bangladesh
API Lot No. Sitagliptin Phosphate Monohydrate B.No 21042602
Metformin Hydrochloride B.No MET 012104013
Description of Pack Alu-alu Blister
No. of Batches 03
DOCUMENTS / DATA TO BE PROVIDED ALONG WITH STABILITY STUDY DATA
1. Reference of previous approval of applications with N/A
stability study data of the firm (if any)
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP Certificate (No.
manufacturer issued by concerned regulatory DA/6-151/2011/8568) dated 05-05-2021 issued by
authority of country of origin. Ministry of health & family welfare, Directorate
general of Drug Administration Oushad Bhaban,
Mohakhali Dakha-1212, Bangladesh . The certificate
specifies that the firm is operating at satisfactory level
of GMP compliance.
3. Documents for the procurement of API with Firm has submitted copy of commercial invoice on 25-
approval from DRAP (in case of import). 05-2021 specifying 5.0Kg of Metformin HCl. And
invoice no 20220722 dated 25-06-2022 of 0.5 kg
Sitagliptin Phosphate Monohydrate
4. Data of stability batches will be supported by Firm has submitted analytical record for product
attested respective documents like chromatograms, testing.
Raw data sheets, COA, summary data sheets etc.
5. Compliance Record of HPLC software 21CFR & N/A
audit trail reports on product testing
6. Record of Digital data logger for temperature and Firm has submitted record of digital data logger for
humidity monitoring of stability chambers (real time temperature and humidity monitoring of real time and
and accelerated) accelerated stability chambers.
Remarks of Evaluator:
Section# Observations Firm’s response

1.6.5 Submit valid GMP/DML certificate of the Firm has submitted copy of DML
manufacturer of Metformin HCl no. 275 valid till 04-10-2023 issued
by DGDA Bangladesh.
Decision: Registration Board approved the applications of “Sitagmin (50/500)” & “Sitagmin
(50/1000)” tablet.
 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.
☐ Importer
2023.
section.
☐ Export sale
The proposed proprietary name / brand name Xetvib 20 mg film coated tablet
Pharmaceutical ingredient (API) per unit Paroxetine as Paroxetine HCl
hemihydrate……… 20 mg
Pharmacotherapeutic Group of (API) Anti-depressant

Pharmaceutical form of applied drug White color round shaped film coated tablets
The status in reference regulatory authorities Approved b yU SFDA
For generic drugs (me-too status) Pronitron Tablet 20mg film coated tablet of M/s
Nabiqasim Industries (Pvt.) Ltd, Karachi (Reg.No.
007990)
Name and address of API manufacturer. M/s Zhejiang Huahai Pharmaceutical Co., Ltd.
Chuannan, Duqiao, Linhai, Zhejiang, 317016,
China
drug product.
30°C ± 2°C / 65% ± 5% RH for 72 months.
Dissolution Profile their product against the Seroxat 20 mg film coated
tablet manufactured by GSK, Pakistan
against the innovator’s product Seroxat 20 mg film
coated tablet in 3 dissolution medias along with
acceptable results for f2 value
product.
Manufacturer of API M/s Zhejiang Huahai Pharmaceutical Co., Ltd.
Chuannan, Duqiao, Linhai, Zhejiang, 317016, China
API Lot No. 5301-20-029

Description of Pack
Alu-alu Blister
No. of Batches 03
manufacturer issued by concerned regulatory ZJ20180073) valid till 25-06-2023 issued by China
authority of country of origin. Food and Drug Administration China . The certificate
specifies that the firm is operating at satisfactory level
of GMP compliance.
3. Documents for the procurement of API with
approval from DRAP (in case of import).

3.2.S.4.2 Drug substance analytical Submitted
procedure from the Drug
substance manufacturer shall
submitted
3.2.S.4.4 COA of drug substance analysis Firm has submitted COA of batch #5301-
for the relevant batch used in the 20-029 from M/s Himark Laboratories.
manufacturing of drug product
stability hatches shall be
submitted from M/s Himark.
3.2.P.8.3  Documents confirming  Firm has submitted copy of
import of drug substance commercial invoice no.
with the approval of DRAP HH20200723R1 specifying 0.412Kg
shall be submitted. of Paroxetine HCl hemihydrate. Firm
 Valid GMP certificate/DML has also submitted DHL slip
of drug substance  Firm has submitted DML# 20000311
manufacture shall be issued by Zhejiang Provincial Drug
submitted since submitted Administration valid till 12-01-2025
GMP certificate was valid till
25-06-2023
Decision: Approved.
318. Name, address of Applicant / Marketing M/s May & Baker Private Limited, 45 KM Dina
Authorization Holder Nath Multan road, Lahore.
Name, address of Manufacturing site. M/s May & Baker Private Limited, 45 KM Dina Nath
Multan road, Lahore.
☐ Importer
GMP status of the firm N/A
Evidence of approval of manufacturing facility Firm has submitted copy of letter of grant of DML
dated 29-04-2022 specifying Capsule (General)
section.
☐ Export sale
Details of fee submitted PKR 30,000/- Dated 05-2023
The proposed proprietary name / brand name Lenzer Delayed release 30mg Capsule
Strength / concentration of drug of Active Each delayed release Capsule contains:
Pharmaceutical ingredient (API) per unit Dexlansoprazole…… 30mg
Pharmacotherapeutic Group of (API) PPI
Pharmaceutical form of applied drug Oral Capsule hard gelatin
The status in reference regulatory authorities Dexilant Capsule 30mg FDA approved
For generic drugs (me-too status) Rodexa of M/s Pharmevo, (Reg.No. 107831)
Name and address of API manufacturer. Vision Pharmaceuticals (Pvt.) Ltd,
Plot No. 22-23, Industrial Triangle, Kahuta
Road, Islamabad- Pakistan
drug product.
30°C ± 2°C / 65% ± 5% RH for 24 months.
Dissolution Profile their product against the innovator’s product
Dexilant 30mg capsule Manufacture by Takeda
Pharmaceuticals.
against the innovator’s product Dexilant 30mg
capsule.
product.

Manufacturer of API Vision Pharmaceuticals (Pvt.) Ltd, Plot No. 22-23, Industrial Triangle, Kahuta
API Lot No. DLP908
Description of Pack
Alu-alu Blister
Batch No. T0001 T0002 T0003
Batch Size 1500 Capsule 1500 Capsule 1500 Capsule
Manufacturing Date 21-08-2022 21-08-2022 21-08-2022
No. of Batches 03
319. Name, address of Applicant / Marketing M/s May & Baker Private Limited, 45 KM Dina
Authorization Holder Nath Multan road, Lahore.
Name, address of Manufacturing site. M/s May & Baker Private Limited, 45 KM Dina Nath
Multan road, Lahore.
☐ Importer
GMP status of the firm N/A
Evidence of approval of manufacturing facility Firm has submitted copy of letter of grant of DML
section.
☐ Export sale
The proposed proprietary name / brand name Lenzer Delayed release 60mg Capsule
Strength / concentration of drug of Active Each delayed release Capsule contains:
Pharmaceutical ingredient (API) per unit Dexlansoprazole…… 60mg
Pharmaceutical form of applied drug Oral Capsule hard gelatin
The status in reference regulatory authorities Dexilant Capsule 60mg FDA approved
For generic drugs (me-too status) Rodexa of M/s Pharmevo, (Reg.No. 107382)
Name and address of API manufacturer. Vision Pharmaceuticals (Pvt.) Ltd,
Plot No. 22-23, Industrial Triangle, Kahuta
drug product.
30°C ± 2°C / 65% ± 5% RH for 24 months.
Dexilant 60mg capsule Manufacture by Takeda
Pharmaceuticals.
against the innovator’s product Dexilant 60mg
capsule.
product.

Manufacturer of API Vision Pharmaceuticals (Pvt.) Ltd, Plot No. 22-23, Industrial Triangle, Kahuta
API Lot No. DLP908
Description of Pack
Alu-alu Blister
Batch No. T0001 T0002 T0003
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API
Firm has submitted copy of GMP Certificate (No. F.3-
manufacturer issued by concerned regulatory
26/2019-Addl- Dir. (QA & LT-1)-56) dated 16-04-
authority of country of origin. 2022 issued by Drug Regularity Authority Pakistan.
The certificate specifies that the firm is operating at
satisfactory level of GMP compliance.
3. Documents for the procurement of API with Firm has submitted the invoice no. 60007 dated
approval from DRAP (in case of import). 08/08/2022 of 5 kg.
attested respective documents like chromatograms, testing of stability batches.
5. Compliance Record of HPLC software 21CFR & Not submitted

3.2.S.4.3 Submit analytical method verification Submitted.
studies for drug substance performed by
M/s May & Baker.
3.2.S.4.4 Dissolution test has not been performed in Firm has submitted drug
drug substance analysis by M/s may & substance analysis COA from
Baker. M/s May & Baker, wherein test
for Dissolution has been
included.
3.2.P.5.1 Justification shall be submitted for not Firm had referred to the
including test of content uniformity in drug performance of test of weight
product specifications. variation for establishing
uniformity of dosage units.
Now firm has submitted
revised drug product
specifications including test of
content uniformity.
3.2.P.5.3 Submit analytical method verification Submitted.
studies of drug product performed by M/s
May & Baker.
3.2.P.8 Submit compliance Record of HPLC Submitted.
software 21CFR & audit trail reports on
product testing.
2.3.R.1 Submit clarification regarding the Firm has submitted
dispensed weight per unit capsule. justification against the
potency of drug substance
determined during drug
substance analysis.
Decision: Registration Board approved the applications of Llenzer 30mg & 60mg capsule
b. New/Additional section(s)
CLB in its 288th meeting held on 18-10-2022 has approved grant of additional section of “Liquid Injectable
Ampoule (General) section” for M/s Seraph Pharmaceutical Plot # 210, Industrial Triangle Kahuta Road
Islamabad.
320. Name, address of Applicant / Marketing M/s Seraph Pharmaceutical Plot # 210,
Authorization Holder Industrial Triangle Kahuta Road Islamabad.
Name, address of Manufacturing site. M/s Seraph Pharmaceutical Plot # 210, Industrial
☐ Importer
11-11-2022 based on inspection conducted on 11-
10-2022.
dated 08-11-2022 specifying Liquid Injectable
Ampoule (General) section.
☐ Export sale
The proposed proprietary name / brand name Seraph WFI 10ml
Strength / concentration of drug of Active Each ampoule contains:
Pharmaceutical ingredient (API) per unit Water for injection ……. 10ml
Pharmacotherapeutic Group of (API) Solvent
Pharmaceutical form of applied drug Clear, Colorless Liquid filled in glass Ampoules.
Proposed Pack size 10ml
The status in reference regulatory authorities Water for injection , MHRA UK
For generic drugs (me-too status) WFI 10ml Surge Laboratories
Name and address of API manufacturer. Seraph Pharmaceutical
specifications, analytical procedures, batch analysis
and justification of specification, reference
standard, container closure system and stability
studies of drug substance and drug product.
related to nomenclature, structure, general
properties, solubilities, physical form,
manufacturers, description of manufacturing
process and controls, specifications, analytical
procedures, batch analysis and justification of
system.
Stability Studies of Drug Substance Firm has submitted that water for injection in bulk
(Conditions & duration of Stability studies) is stored in SS container and is filled in ampoules
within 24 hours therefore stability studies are not
required to be carried out in this container closure
system.
Module-III Drug Product: Firm has submitted data of drug product including
its description, composition, pharmaceutical
analytical procedures, batch analysis, justification
of specifications, reference standard or materials,
Pharmaceutical Equivalence and Comparative Firm has submitted Pharmaceutical equivalence
Dissolution Profile against WFI of M/s Surge Laboratories.
Analytical method validation/verification of Not submitted

product
Manufacturer of API Seraph Pharmaceutical
API Lot No. NA
Description of Pack
One glass ampoule containing 10ml water for injection.
Batch Size 1000 ampoules 1000 ampoules 1000 ampoules
No. of Batches 03
321. Name, address of Applicant / Marketing M/s Seraph Pharmaceutical Plot # 210 Industrial
Authorization Holder Triangle Kahuta Road, Islamabad.
Name, address of Manufacturing site. M/s Seraph Pharmaceutical Plot # 210 Industrial
Triangle Kahuta Road, Islamabad.
☐ Importer
11-11-2022, based on inspection conducted on 11-
10-2022.
dated 08-11-2022 specifying Liquid injectable
ampoule (General) section.
☐ Export sale
Pharmaceutical ingredient (API) per unit Water for Injection …………. 2ml
Pharmaceutical form of applied drug Clear colorless liquid filled in glass ampoules.
The status in reference regulatory authorities Water for injection , MHRA UK.
For generic drugs (me-too status) Water for Injection 2ml Surge Laboratories
drug product.
system of drug substance.
system.
Pharmaceutical Equivalence and Comparative Not submitted
Dissolution Profile
product
Manufacturer of API Seraph Pharmaceutical
API Lot No. N/A
Description of Pack
One glass Ampoule containing 2ml water for injection

Batch Size 1000 Ampoules 1000 Ampoules 1000 Ampoules
No. of Batches 03
☐ Importer
11-11-2022,based on inspection conducted on 11-
10-2022.
☐ Export sale
Strength / concentration of drug of Active Each ampoule contains:
Pharmaceutical ingredient (API) per unit Water for injection ……. 5ml
The status in reference regulatory authorities Water for injection , MHRA UK
For generic drugs (me-too status) WFI 5ml Surge Laboratories
specifications, analytical procedures, batch analysis
system.
system.
Dissolution Profile against WFI of M/s Surge Laboratories.

product
Manufacturer of API M/s Seraph Pharmaceutical
API Lot No. NA
Description of Pack
One glass ampoule containing 5ml water for injection.
No. of Batches 03
1. Reference of previous approval of applications with Our facility has been inspected by panel of
stability study data of the firm (if any) inspectors for verification of stability study data
for following products.
a) Dexpro (Dexlansoprazole) 30 and 60mg
Capsule approved in 285th meeting of
Registration Board.
b) Neovel 800mg Tablet approved in 288th
meeting of Registration Board.
c) Serbica 20mg Capsule approved in 290th
manufacturer issued by concerned regulatory F.3-7/2018-Addl.Dir/(QA &LT-1) dated 11-11-2022.
authority of country of origin. The certificate specifies that the firm is operating at
3. Documents for the procurement of API with Not applicable
5. Compliance Record of HPLC software 21CFR & Not applicable
humidity monitoring of stability chambers (real temperature and humidity monitoring of real time and
time and accelerated) accelerated stability chambers.
Section # Observation Firm’s response

3.2.P.2.2.1 Pharmaceutical Submitted
equivalence report for the
WFI 2 ml fill volume shall
be submitted.
3.2.P.8.3 Stability studies of 6th Firm has submitted stability record for 6th month time
month time point shall be point.
submitted.
Decision: Registration Board approved the applications of “Seraph WFI 10ml “, “Seraph WFI 2ml “, &
“Seraph WFI 5ml”.
☐ Importer
10-2022.
☐ Export sale
The proposed proprietary name / brand name Seraph NS 5ml Injection
Pharmaceutical ingredient (API) per unit Sodium Chloride…….0.9mg (0.9%)
Pharmacotherapeutic Group of (API) Mineral Supplement
The status in reference regulatory authorities Sodium Chloride Injection BP 0.9% w/v, Hameln
Pharma Ltd, UK MHRA UK
For generic drugs (me-too status) Celine 0.9% Injection (5ml) Surge Labortories
(Reg.No. 074266)
Name and address of API manufacturer. M/s Salinen Austria AG, Salinen Austria AG
Steinkogelstrasse 30, 4802 Ebensee, Austria.
drug product.
procedures and its validation, batch analysis and
justification of specification, reference standard,
container closure system and stability studies of
drug substance.
30°C ± 2°C / 65% ± 5% RH for 48 months.
Sodium Chloride Injection BP 0.9% w/v
manufactured Hameln pharma ltd, UK
product.
Manufacturer of API Salinen Austria AG, Salinen Austria AG Steinkogelstrasse 30, 4802 Ebensee,
Austria.
API Lot No. CRS190122
Description of Pack
One glass ampoule containing 5ml (0.9%) Sodium chloride.
No. of Batches 03
☐ Importer
10-2022.
☐ Export sale
The proposed proprietary name / brand name Seraph NS 10ml
Pharmaceutical ingredient (API) per unit Sodium chloride …………. 9mg (0.9%)
Pharmacotherapeutic Group of (API) Mineral Supplements
The status in reference regulatory authorities Sodium chloride injection BP 0.9% W/V, Hameln
Pharma Ltd, UK, MHRA UK.
For generic drugs (me-too status) Celine 0.9% Injection (10ml) Surge Laboratories
(Reg. No. 074266)
Name and address of API manufacturer. Salinen Austria AG, Salinen Austria AG
Steinkogelstrasse 30, 4802 Ebensee, Austria .
drug product.
drug substance.
30°C ± 2°C / 65% ± 5% RH for 48 months.
Sodium chloride injection BP 0.9% W/V, Hameln
Pharma Ltd, UK, MHRA UK.
product.
Manufacturer of API Salinen Austria AG, Salinen Austria AG Steinkogelstrasse 30, 4802 Ebensee,
Austria .
API Lot No. CRS190122
Description of Pack
One glass Ampoule containing 10ml (0.9%) sodium chloride
No. of Batches 03
Registration Board.
manufacturer issued by concerned regulatory --
authority of country of origin.
3. Documents for the procurement of API with Firm has submitted copy of commercial invoice
approval from DRAP (in case of import). cleared on 21-04-2022 specifying 24500Kg issued to
Lakhani Pharma, from Lakhain pharma. Firm has also
submitted Loan letter Ser/SRB/DRAB/ISB/2023-02
from M/s Lakahni Pharma
attested respective documents like chromatograms, testing for stability studies.
5. Compliance Record of HPLC software 21CFR & Not Applicable

1.6.5 Submit valid GMP certificate/DML for the drug Firm has submitted copy of
substance manufacturer issued by the relevant GMP Certificate (No. INS-
regulatory authority. 481329-14173814/17029593
valid till 26-07-2024 issued
by Ministry of Austria.
3.2.S.4.2 Drug substance analytical procedure shall be Submitted
submitted for M/s Seraph Pharmaceuticals.
3.2.P.8.3 Submit stability studies for the 6th month time Submitted.
point.
Decision: Registration Board approved the applications of “Seraph NS 5ml Injection” & “Seraph NS
10ml”.
☐ Importer
10-2022.
dated 08-11-2022 specifying liquid Injectable
ampoule section (General).
☐ Export sale
The proposed proprietary name / brand name D-Strong Injection 7.5 mg
Strength / concentration of drug of Active One Ampoule contains:
Pharmaceutical ingredient (API) per unit Cholecalciferol (vitamin D3) 7.5 mg, which
corresponds to 300000 I.U.
Pharmacotherapeutic Group of (API) Vitamin.
Pharmaceutical form of applied drug Liquid injection
The status in reference regulatory authorities Xarenel Italfarmaco S.p.A.
Xarenel® Injection is Approved in AIFA of Italy
For generic drugs (me-too status) NA
Name and address of API manufacturer. M/s Fermenta Biotech Limited.

Village Takoli, P.O. Nagwain, Dist. Mandi-
175121, Himachal Pradesh, India
drug product.
drug substance.
5°C ± 3°C / 60% ± 5% RH for 36 months.
Dissolution Profile studies against the Xarenel® Injection.
product.
Manufacturer of API
M/s Fermenta Biotech Limited. Village Takoli, P.O. Nagwain, Dist. Mandi-
175121, Himachal Pradesh, India
API Lot No. CLC0421283

Description of Pack Colecalciferol is filled clear, sterilized Printed Glass
(Container closure system) ampoule.

Batch Size 2000 Injections 2000 Injections 2000 Injections
Date of Initiation 11-2022 11-2022 11-2022
No. of Batches 03
Registration Board.
2. Approval of API/ DML/GMP certificate of API GMP Certicate No 2062043 dated issued by
manufacturer issued by concerned regulatory Food & Drugs Control Administration, Gujarat
authority of country of origin. State, India valid till 17-06-2023.
3. Documents for the procurement of API with Firm has submitted Clearance certificate no. E-
approval from DRAP (in case of import). 63186525961 dated 11-02-2022 for the import of
1Kg of Cholecalciferol.
attested respective documents like chromatograms, testing for the stability batches

1.1 Differential fee of Rs. 45,000/- shall be Firm has submitted Differential fee
submitted since applied formulation is not of Rs. 45,000/-. Vide deposit slip#
previously registered by DRAP. 765198550034.
3.2.P.1 Justification shall be submitted for proposed Frim has referred to USP general
excess fill volume per unit ampoule. chapter for the provision of excess
fill volume.
th
3.2.P.8.3 Submit stability studies for the 6 month time Submitted
point.
2.3.R.1 Complete batch manufacturing record for the Submitted
stability batches shall be submitted.
Decision: Approved
☐ Importer
10-2022.
☐ Export sale
The proposed proprietary name / brand name Lidox Injection 3.5 ml
Strength / concentration of drug of Active Each 3.5 ml contains:
Pharmaceutical ingredient (API) per unit Lidocaine Hydrochloride …………. 35mg
Pharmacotherapeutic Group of (API) Local Anesthetics
Proposed Pack size 3.5ml
For generic drugs (me-too status) Lidocain 1% Solution Tabros Pharma (045163)
Name and address of API manufacturer. M/s Alcon Biosciences (Pvt) Ltf. S-1/2104, Phase
III, G.I.D.C VAPI 369 195 District Valsad, Gujarat
India.
drug product.
drug substance.
30°C ± 2°C / 65% ± 5% RH for 24 months.

Dissolution Profile studies against the Lignocaine injection 3.5ml of
M/s Tabros Pharma.
product.
Manufacturer of API M/s Alcon Biosciences (Pvt) Ltf. S-1/2104, Phase III, G.I.D.C VAPI 369 195
District Valsad, Gujarat India.
API Lot No. U4-1021/20
Description of Pack
One glass Ampoule containing 3.5ml of Lidocain injection
No. of Batches 03
Registration Board.
2. Approval of API/ DML/GMP certificate of API GMP Certiifcate no. S-GMP20102297 of M/s Alcon
manufacturer issued by concerned regulatory Biosciences (Pvt) Ltd. A-1/2104, Phase III, G.I.D.C
authority of country of origin. VAPI 369 195 District Valsad, Gujrat India , issued
by Food & Drugs Control Administration, valid upto
21-10-2022
approval from DRAP (in case of import). cleared on 15-01-2021 in name of Wimits Pharma.
Firm has also submitted Loan letter from M/s Wimits
Pharma in name of M/s Seraph Pharmaceutical for
Lignocaine HCl.
☐ Importer
10-2022.
☐ Export sale
The proposed proprietary name / brand name Lidox 2ml Injection
Pharmaceutical ingredient (API) per unit Lidocaine hydrochloride……20mg
Pharmacotherapeutic Group of (API) Local anesthetics
Proposed Pack size 2 ml
For generic drugs (me-too status) Lignocaine 1% injection of M/s Surge Laboratories
(026761)
Name and address of API manufacturer. M/s Alcon Biosciences (Pvt) Ltd. A-1/2104, Phase
III, G.I.D.C VAPI 369 195 District Valsad,
Gujrat India.
drug product.
drug substance.
30°C ± 2°C / 65% ± 5% RH for 24 months.
Dissolution Profile studies against the Lignocaine injection of M/s
Surge Laboratories.
Analytical method validation/verification of Firm has submitted analytical method verification
product.
Manufacturer of API M/s Alcon Biosciences (Pvt) Ltd. A-1/2104, Phase III, G.I.D.C VAPI 369 195
District Valsad, Gujrat India.
API Lot No. U4-1021/20
Description of Pack
One glass ampoule containing 2ml Lidocaine injection.
No. of Batches 03
Registration Board.
approval from DRAP (in case of import). cleared on 15-01-2021 in name of Wimits Pharma.
Firm has also submitted Loan letter from M/s Wimits
Pharma in name of M/s Seraph Pharmaceutical for
Lignocaine HCl.

1..6.5 Submit valid GMP certificate/DML issued by GMP Certiifcate no. S-
relevant regulatory authority of country of GMP20102297 of M/s Alcon
origin. Biosciences (Pvt) Ltd. A-1/2104,
Phase III, G.I.D.C VAPI 369 195
District Valsad, Gujrat India ,
issued by Food & Drugs Control
Administration, valid upto 21-10-
2022
th
3.2.P.8.3 Submit stability studies for the 6 month time Submitted
point.
2.3.R.1 Submit batch manufacturing record of stability Submitted
trial batches.
Decision: Registration Board approved the applications of “Lidox Injection 3.5 ml” & “Lidox 2ml
Injection”.
☐ Importer
10-2022.
☐ Export sale
The proposed proprietary name / brand name RestOn Injection 8 mg/4 ml.
Pharmaceutical ingredient (API) per unit Ondansetron as HCl Dihydrate……8 mg
Pharmacotherapeutic Group of (API) Anti-Emetic
Proposed Pack size 4 ml
The status in reference regulatory authorities Zofran®, Novartis, Zofran® Injection is Approved
in USFDA
For generic drugs (me-too status) Zofran Injection (Reg.# 020669)
Block No. 251-252 Sachin- Magdalla Road GIDC,
Sachin, Surat – 394 230 Gujarat, INDIA
drug product.
drug substance.
30°C ± 2°C / 65% ± 5% RH for 72 months.
Dissolution Profile studies against the Zofran Injection 8mg/4ml.

product.
Manufacturer of API M/s CTX Lifesciences Pvt. Ltd.
Block No. 251-252 Sachin- Magdalla Road GIDC, Sachin, Surat – 394 230
Gujarat, INDIA
API Lot No. 22ON000019
Description of Pack
One glass ampoule containing 4ml Reston injection (2mg/ml)
Batch No. T001 T002
Batch Size 2000 ampoules
2000 ampoules
Manufacturing Date 11-2022 11-2022

Date of Initiation 11-2022 11-2022
No. of Batches 02
Registration Board.
4Kg of Ondansetron HCl in name of M/s Swiss
Pharmaceutical, along with loan letter in name of M/s
Seraph pharmaceuticals.
attested respective documents like chromatograms, testing for stability studies.
humidity monitoring of stability chambers (real time temperature and humidity monitoring of real time
and accelerated) and accelerated stability chambers.

1.6.5 Submit valid GMP certificate/DML for Firm has submitted GMP Certiifcate no.
the drug substance manufacturer issued 19061470 issued by Food and Drugs
by the relevant regulatory authority. Control Administration Gujrat India.
3.2.P.5.3 Concentration levels in terms of mg/ml Firm has submitted revised analytical
shall be declared in the performance of method verification studies report with
accuracy parameter in analytical method concentrations declared in terms of
verification studies. mg/ml for the performance of accuracy
parameter.
3.2.P.6 COA of reference working standard, Submitted.
used for the analysis of stability batches,
shale be submitted.
3.2.P.8.3 Stability studies data of 6th month time Submitted.
point shall be submitted.
Decision: Approved.
M/s Seraph had been granted DML# 000860 dated 12-06-2017 including “Dry Vial Cephalosporin
section.”. Firm has applied following formulations against their balance quota of priority
consideration of 10 molecules per section.
☐ Importer
10-2022.
dated 12-06-2017 specifying Dry vial
Cephalosporine Section.
☐ Export sale
The proposed proprietary name / brand name Cefavidime 2.0/0.5G Injection IM/IV
Strength / concentration of drug of Active Each Vial contains:
Pharmaceutical ingredient (API) per unit Ceftazidime…….2g
Avibactam…….0.5g
Pharmacotherapeutic Group of (API) Third-generation cephalosporin
Pharmaceutical form of applied drug A White or Light Yellow Sterile free flowing
powder Filled in Vials Packed in Unit Carton.
Reference to Finished product specifications Innovator specifications.
The status in reference regulatory authorities Avycaz 2/0.5g injection Allergan Pharma Limited
FDA Approved drugs
For generic drugs (me-too status) Zavicefta 2g/0.5g injection Pfizer PVT Limited
Name and address of API manufacturer. Qilu Antibiotics Pharmaceutical CO., Ltd. No.849
Dongjia town Licheng District China 250105
Jinan,Shangdong Province.
drug product.
drug substance.
30°C ± 2°C / 65% ± 5% RH for 9 months.
Dissolution Profile studies against Avycaz 2/0.5g injection Allergan
Pharma Limited FDA Approved drugs
product.

Manufacturer of API Qilu Antibiotics Pharmaceutical CO., Ltd.
API Lot No. 2001GJ85JB
Description of Pack A White or Light Yellow Sterile free flowing powder Filled in Vials Packed
(Container closure system) in Unit Carton
Time Period Real time: 3, 6 months
Accelerated: 3, 6 months
Batch Size 214 Packs 214 Packs 214 Packs
No. of Batches 03
Registration Board.
3. Documents for the procurement of API with Firm has submitted Clearance Certificate No.E-
approval from DRAP (in case of import). 3335386526318 for the import of 2Kg of
Ceftazidime+Avibactam.
4. Data of stability batches will be supported by Submitted
attested respective documents like chromatograms,

3.2.S.4.4 Justification shall be submitted for not Firm has referred to the COA
performing test for “Pyridine content” by M./s of drug substance
Seraph pharmaceuticals. manufacturer and stated that
they have relied upon the
results of “Pyridine content”
performed by the Drug
substance manufacturer.
3.2.P.2.5 Submit compatibility study with the Frim has submitted
reconstitution diluent. compatibility studies with
water for injection.
3.2.P.5.1 Justification shall be submitted for not Firm has referred to the COA
including test of “Pyridine content” in drug of drug substance
product specifications as recommended by manufacturer and stated that
Innovator drug product. they have relied upon the
results of “Pyridine content”
performed by the Drug
substance manufacturer since
applied formulation is
formulated as ready to fill
powder for injection.
3.2.P.8.3  Submit stability data of 6 month time  Firm has submitted 6th
th
point. month time point study.

 Submit valid GMP certificate of drug  Firm has submitted Copy
substance manufacturer issued by relevant of GMP certificate
regulatory authority. (No.SD20190876) issued
by CFDA China is
submitted by the firm.
The certificate is valid till
21-04-2024.
 Firm has also submitted
copy of DML of the firm
(No. Lu 20160006) issued
by CFDA China. The
license is valid till 03-11-
2025.
3.2.R Justify the dispensed weight per unit vial with Firm has referred to the
reference to the potency of drug substance potency of drug substance
determined during drug substance analysis. determined during drug
substance analysis on “as is
basis” for calculation of
weight per unit vial.
Decision: Approved.
☐ Importer
10-2022.
dated 12-06-2017 specifying Dry vial
Cephalosporin section.
☐ Export sale
The proposed proprietary name / brand name
Ceffosa Injection 600mg IV/IM
Pharmaceutical ingredient (API) per unit Ceftaroline Fosamil (As L-rginine) …… 600mg
Pharmacotherapeutic Group of (API) Third-generation cephalosporins
Pharmaceutical form of applied drug White to off white powder filled in glass vial.
Reference to Finished product specifications In house
The status in reference regulatory authorities Teflaro 600mg Injecion, Allergan pharma Ireland,
FDA Approved Drug.
For generic drugs (me-too status) Zinforo Injection 600mg, Pfizer Pvt Limited. (Reg.#
110515)
Name and address of API manufacturer. M/s Qingdao Xinnuo Pharmaceutical Chemical
Co., Ltd. 50 meters North Yuanhou Neighborhood
Committee Xifuzhen Street Chenyang Area
Qingdao Shandong, CHINA
drug product.
drug substance.
25°C ± 2°C / 60% ± 5% RH for 9 months.
Pharmaceutical Equivalence and Comparative Pharmaceutical equivalence studies have been
Dissolution Profile submitted against the Innovator drug product of
Zinforo 600mg injection.
product.
Manufacturer of API M/s Qingdao Xinnuo Pharmaceutical Chemical Co., Ltd. 50 meters North
Yuanhou Neighborhood Committee Xifuzhen Street Chenyang Area Qingdao
Shandong, CHINA
API Lot No. 20221002
Description of Pack
White to off white powder filled in glass vial.
Batch Size 246 Packs 246 Packs 246 Packs
No. of Batches 03
Registration Board.
801gm of Ceftaroline fosamil with L-Arginine.
5. Compliance Record of HPLC software 21CFR & Submitted

1.6.5 Submit valid GMP certificate/DML for the Firm has submitted GMP
drug substance manufacturer issued by the certificate valid till 15-09-2025
relevant regulatory authority. issued by Center for evaluation &
certification of Shandong
Pharmaceutical Industry
Association.
3.2.S.4  Submitted specifications does not include  Firm has submitted analytical
test of “Acetic acid” content. procedure and specifications
 Drug substance specifications, analytical applied by M/s Seraph
procedure and analytical method pharmaceuticals including test
verification studies shall be submitted of Acetic acid.
from M/s Seraph Pharmaceuticals.  Firm has submitted microbial
 Reports for sterility test of drug substance reports for the sterility testing
performed by M/s Seraph pharmaceutical of drug substance.
shall be submitted.
3.2.S.7.3 Stability studies of drug substance shall be Firm has submitted long term
submitted as per zone-IVA conditions. stability studies as per Zone IVA
conditions form drug substance
manufacturer.
3.2.P.2.5 Compatibility studies of the applied drug Firm has submitted compatibility
product with re constitution diluent shall be study with both water for injection
submitted. and 0.9% NaCl as reconstitution
diluent.
3.2.P.5.3 Performance of robustness parameter shall be Submitted
submitted in drug product analytical method
validation studies.
3.2.P.5.4 Reports for sterility test of drug product of Microbiological reports submitted
trial batches shall be submitted. for performance for sterility tests.
3.2.P.8.3 Submit stability studies for the 6th month time Submitted.
point.
Decision: Approved with Innovator’s specifications. The firm shall submit 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 07-05-2021, before issuance of registration letter.
CLB in its 276th meeting held on 03rd September, 2020 has approved grant of additional section of Tablet
(General) section for M/s Quaper Private Limited 26-A Small Industrial Estate Lahore Road Sargodha.
Now firm has applied following applications for priority consideration against new section priority.
331. Name, address of Applicant / Marketing M/s Quaper Private Limited 26-A Small
Authorization Holder Industrial Estate Lahore Road Sargodha.
Name, address of Manufacturing site. M/s Quaper Private Limited 26-A Small Industrial
Estate Lahore Road Sargodha.
☐ Importer
2022.
section.
☐ Export sale
The proposed proprietary name / brand name PAINOXIA 90mg Tablet
Pharmaceutical ingredient (API) per unit Etoricoxib…… 90 mg
Pharmacotherapeutic Group of (API) Antirheumatic
Pharmaceutical form of applied drug Film coated green colored round tablet
Reference to Finished product specifications Innovator’s Specifications
The status in reference regulatory authorities Arcoxia Tablet approved by AEMPS of Spain
For generic drugs (me-too status) Starcox Tablet 90 mg of M/s Getz pharma, Pakistan
Private Limited. (Reg.No. 105293)
Name and address of API manufacturer. M/s Kekule Pharma Limited
MIA, Khazipally, Jinnaram Mandal Medak District,
Telangana State. India – 502 319.
drug product.
30°C ± 2°C / 65% ± 5% RH for 24 months.
Dissolution Profile their product against the innovator’s product Starcox
Tablet 90 mg manufactured by Getz pharma,
Pakistan Limited.
against the Starcox Tablet 90 mg of mM/s Getz in 3
dissolution medias.
product.
Manufacturer of API M/s Kekule Pharma Limited
MIA, Khazipally, Jinnaram Mandal Medak District, Telangana State. India –
502 319.
API Lot No. ACE06222
Description of Pack
Alu-alu Blister
Batch No. PAINOXIA/90-01 PAINOXIA/90-02 PAINOXIA/90-03
No. of Batches 03
☐ Importer
2022.
specifying Tablet (General) section.
☐ Export sale
The proposed proprietary name / brand name PAINOXIA 60mg Tablet
Pharmaceutical ingredient (API) per unit Etoricoxib…… 60 mg
Pharmacotherapeutic Group of (API) Antirheumatic
Pharmaceutical form of applied drug Film coated green colored round tablet
The status in reference regulatory authorities Arcoxia Tablet approved by AEMPS of Spain
For generic drugs (me-too status) Starcox Tablet 60 mg of M/s Getz pharma, Pakistan
Name and address of API manufacturer. M/s Kekule Pharma Limited
MIA, Khazipally, Jinnaram Mandal Medak District,
Telangana State. India – 502 319.
drug product.
30°C ± 2°C / 65% ± 5% RH for 24 months.
Dissolution Profile their product against the innovator’s product Starcox
Tablet 60 mg manufactured by Getz pharma,
Pakistan Limited.
against the Starcox Tablet 60 mg of m/s Getz in 3
dissolution medias.
product.
Manufacturer of API M/s Kekule Pharma Limited MIA, Khazipally, Jinnaram Mandal Medak
District, Telangana State. India – 502 319.
API Lot No. ACE06222
Description of Pack
Alu-alu Blister
Batch No. PAINOXIA-01 PAINOXIA-02 PAINOXIA-03
Batch Size 3000Tablet 3000 Tablet 3000 Tablet
No. of Batches 03
1. Reference of previous approval of applications with Not available
approval from DRAP (in case of import). cleared on 01-07-2022 in name of M/s Wimits
Pharmaceuticals specifying 25Kg of Etoricoxib. The
invoice is cleared by AD (I&E) DRAP, Lahore.
Firm has also submitted loan letter for the Etoricoxib
from M/s Wimits pharmaceuticals in name of m/s
Quaper.
attested respective documents like chromatograms, testing for the stability batches.

1.6.5 Submit valid GMP
Firm has submitted copy of License no.
certificate/DML of drug
97906/TS/2022 valid till 06-12-2025 issued by
substance manufacturer issued
Drugs Control Administration Government of
by concerned regulatory
Telangana India.
authority.
3.2.S.4.3 Analytical method Submitted
verification studies of drug
substance performed by M/s
Quaper Pharmaceuticals shall
be submitted.
3.2.P.2.2.1 Justification shall be Due to non-availability of innovator drug product
submitted for not performing in the market we used the locally available brand
of Pharmaceutical & CDP of Starcox tablet for M/s Getz for comparative
studies against the innovator studies.
drug product.
3.2.P.8.3 Submit raw data sheets for the Submitted.
dissolution test performed
during stability studies.
Decision: Registration Board approved the applications of “PAINOXIA 90mg Tablet” & “PAINOXIA
60mg Tablet”.
☐ Importer
2022.
section.
☐ Export sale
The proposed proprietary name / brand name QUZAN 10mg Tablet
Pharmaceutical ingredient (API) per unit Vonoprazan Fumarate eq .to
Vonoprazan………………10 mg
Pharmacotherapeutic Group of (API) Potassium-competitive acid blocker
Pharmaceutical form of applied drug Film coated yellow colored oblong tablet
The status in reference regulatory authorities Vonoprazan Tablet (PMDA Approved)
For generic drugs (me-too status) Vonozan Tablet 10 mg of M/s Getz pharma, Pakistan
Name and address of API manufacturer. M/s Yinbin Hongguang Pharmaceutical Co.,
Ltd Luolong county nanxi district, Yinbin
City, Sichuan Province China.
drug product.
30°C ± 2°C / 65% ± 5% RH for 24 months.
Vonozan Tablet 10 mg manufactured by Getz
pharma, Pakistan Limited.
against Vonozan Tablet 10 mg by Getz pharma,
Pakistan Limited in 3 dissolution medias.
product.
Manufacturer of API M/s Yinbin Hongguang Pharmaceutical Co., Ltd Luolong county nanxi
district, Yinbin City, Sichuan Province China.
API Lot No. MS103201-210901
Description of Pack
Alu-PVC Blister
Batch No. T1/22 T2/22 T3/22
No. of Batches 03
☐ Importer
2022.
section.
☐ Export sale
The proposed proprietary name / brand name QUZAN 20mg Tablet
Pharmaceutical ingredient (API) per unit Vonoprazan Fumarate eq .to
Vonoprazan………………20 mg
Pharmacotherapeutic Group of (API) Potassium-competitive acid blocker
Pharmaceutical form of applied drug Film coated pink colored oblong tablet
The status in reference regulatory authorities Vonoprazan Tablet (PMDA Approved)
For generic drugs (me-too status) Vonozan Tablet 20 mg of M/s Getz pharma, Pakistan
Name and address of API manufacturer. M/s Yinbin Hongguang Pharmaceutical Co.,
Ltd Luolong county nanxi district, Yinbin
City, Sichuan Province China.
drug product.
30°C ± 2°C / 65% ± 5% RH for 24 months.
Vonozan Tablet 20 mg manufactured by Getz
pharma, Pakistan Limited.
against the Vonozan Tablet
20 mg manufactured by Getz pharma, Pakistan
Limited in 3 dissolution medias.
product.
Manufacturer of API M/s Yinbin Hongguang Pharmaceutical Co., Ltd Luolong county nanxi
district, Yinbin City, Sichuan Province China.
API Lot No. MS103201-210901
Description of Pack
Alu-PVC Blister
Batch No. T1/22 T2/22 T3/22
No. of Batches 03
1. Reference of previous approval of applications with The firm has not submitted any document.
3. Documents for the procurement of API with --
Remarks of EvaluatorII:

1.6.5 Submit valid GMP certificate/DML of drug
substance manufacturer from relevant Firm has submitted copy of GMP
regulatory authority since submitted GMP Certificate# SC20170003 valid till
certificate has been issued by Yibin 16-03-2022 issued by CFDA.
Association of Pharmaceutical Industry.
3.2.P.5.1 Justification shall be submitted for not Firm has submitted revised drug
including test of content uniformity in the product specifications including test
drug product specifications. for content uniformity.
3.2.P.8.3 Documents confirming import of drug Firm has submitted copy of
substance shall be submitted. commercial invoice attested by AD
I&E DRAP, Lahore dated 08-11-
2021 specifying 200g of
Vonoprazan fumarate.
Decision: Registration Board approved the applications of “QUZAN 10mg Tablet” & “QUZAN 20mg
Tablet”.
☐ Importer
2022.
section.
☐ Export sale
The proposed proprietary name / brand name TERBI-Q 250mg Tablet
Pharmaceutical ingredient (API) per unit Terbinafine (as hydrochloride)…… 250 mg
Pharmacotherapeutic Group of (API) Antifungal for systemic use
Pharmaceutical form of applied drug White colored round uncoated tablet
The status in reference regulatory authorities Lamisil Tablet (TGA Australia Approved)
For generic drugs (me-too status) Lamisil Tablet 250 mg of M/s Novartis pharma,
Pakistan Limited. (Reg.No. 013209)
Name and address of API manufacturer. Saptagir Laboratories Pvt. Ltd. Sy. No. Parts of 27,
46 and 50 to 56, Ananthsagar village, Chegunta
mandal, Medak dist, Tilangana-502247, India.
drug product.
30°C ± 2°C / 65% ± 5% RH for 24 months.
Dissolution Profile their product against the innovator’s product Lamisil
Tablet 250 mg manufactured by Novartis pharma,
Pakistan Limited.
against the innovator’s product Lamisil Tablet 250
mg in 3 dissolution medias.
product.
Manufacturer of API Saptagir Laboratories Pvt. Ltd. Sy. No. Parts of 27, 46 and 50 to 56,
Ananthsagar village, Chegunta mandal, Medak dist, Tilangana-502247, India.
API Lot No. TER04422
Description of Pack
Alu-alu Blister
No. of Batches 03
☐ Importer
2022.
section.
☐ Export sale
Dy. No. and date of submission Dy. No. 14522 dated 09-06-2023
The proposed proprietary name / brand name TERBI-Q 125mg Tablet
Pharmaceutical ingredient (API) per unit Terbinafine (as hydrochloride)…… 125 mg
Pharmacotherapeutic Group of (API) Antifungal for systemic use
Pharmaceutical form of applied drug White colored round uncoated tablet
The status in reference regulatory authorities Lamisil Tablet (TGA Australia Approved)
For generic drugs (me-too status) Lamisil Tablet 125 mg of M/s Novartis pharma,
Pakistan Limited. (Reg.No. 013208)
Name and address of API manufacturer. Saptagir Laboratories Pvt. Ltd. Sy. No. Parts of 27,
46 and 50 to 56, Ananthsagar village, Chegunta
mandal, Medak dist, Tilangana-502247, India.
drug product.
30°C ± 2°C / 65% ± 5% RH for 24 months.
Dissolution Profile their product against the innovator’s product Lamisil
Tablet 125 mg manufactured by Novartis pharma,
Pakistan Limited.
against the innovator’s product Lamisil Tablet 125
mg in 3 dissolution medias.
product.
Manufacturer of API Saptagir Laboratories Pvt. Ltd. Sy. No. Parts of 27, 46 and 50 to 56,
Ananthsagar village, Chegunta mandal, Medak dist, Tilangana-502247, India.
API Lot No. TER04422
Description of Pack
Alu-alu Blister
No. of Batches 03
1. Reference of previous approval of applications with The firm has not submitted any document.
manufacturer issued by concerned regulatory 54991/TS/2021) valid upto 01-03-2022 issued by
authority of country of origin. Drugs Control Administration Government of
Telangana India.
approval from DRAP (in case of import). cleared on 23-11-2022 specifying 150Kg of
Terbinafine. The invoice is cleared by AD (I&E)
DRAP, Lahore in name of M/s Wimits
Pharmaceuticals. Firm has also submitted Loan letter
form M./s Wimits Pharmaceuticals in name of M.s
Quaper Pharmaceuticals
Decision: Registration Board approved the applications of “TERBI-Q 250mg Tablet” & “TERBI-Q
125mg Tablet”.
M/s Wimits Pharmaceuticals (Pvt.) Ltd. Lahore. Plot #129 Sundar Industrial Estate, Raiwind road, Lahore
The Central Licensing Board in its 286th meeting held on 11th May, 2022 has considered and approved the
grant of Drug Manufacturing License to M/s Wimits Pharmaceuticals (Pvt.) Ltd. Lahore. Plot #129 Sundar
Industrial Estate, Raiwind road, Lahore by way of Formulation vide approval letter No. F. 1-10/2012-Lic
dated 7th June, 2022 with 3 sections including “Dry Powder Injection (Cephalosporin) Section”.
337. Name, address of Applicant / Marketing M/s Wimits Pharmaceuticals (Pvt) Ltd. Lahore. Plot
Authorization Holder #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
Intended use of pharmaceutical product ☐Domestic sale
☐ Export sale
☒Domestic and Export sales
The proposed proprietary name / brand name Welcef 2g IV injection
Pharmaceutical ingredient (API) per unit Ceftriaxone Sodium eq. to Ceftriaxone…2g
Pharmaceutical form of applied drug Dry powder injection
Pharmacotherapeutic Group of (API) Cephalosporin Antibiotics
The status in reference regulatory authorities Approved by US FDA
GMP status of the Finished product GMP Certificate No.70/2021-DRAP(FID/2061717-
manufacturer 540) Dated 08-09-21
Name and address of API manufacturer. M/s. SinopharmWeiqida Pharmaceutical Co., Ltd.
Pharmaceutical Industrial Park, Economic &
Technological Development Zone, Datong, Shanxi,
China 037300.
template. Summarized information related to
nomenclature, structure, general properties,
solubilities, physical form, manufacturers, description
of manufacturing process and controls, impurities,
verification, batch analysis and justification of
drug product is submitted.
Module III (Drug Substance) Official monograph of Ceftriaxone sodium is present
in USP. The firm as submitted detail of nomenclature,
structure, general properties, solubilities, physical
form, manufacturers, description of manufacturing
process and controls, tests for impurity,
system and stability studies of drug substance
Stability studies Stability study conditions:
Real time: 30°C ± 2°C /65% ± 5%RH for 48 months
Accelerated: 40°C ± 2°C / 75% ± 5%RH for 6 months
Batches: (Q012008048, Q012008049, Q012008050)
Module-III (Drug Product): The firm has submitted detail of manufacturers,
impurities, specifications, analytical procedure and its
verification studies, batch analysis and justification of
system and stability studies of drug product.
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence have been established
dissolution profile against the brand leader that is Oxidil injection 2g IV
by M/s Sami by performing quality tests
(Identification, PH, Assay)
Analytical method validation/verification of Method verification studies have submitted including
product linearity, range, accuracy, precision, specificity.
Manufacturer of API M/s. Sinopharm Weiqida Pharmaceutical Co., Ltd.
Address: Pharmaceutical Industrial Park, Economic & Technological
Development Zone, Datong, Shanxi, China 037300.
API Lot No. Q012202234
Description of Pack
Glass vial
Batch No. TDV001 TDV002 TDV003
Batch Size 500Vials 500Vials 500Vials
No. of Batches 03
Administrative Portion
1. Reference of previous approval of applications The firm has not submitted any document.
with stability study data of the firm (if any)
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. SX20180229 issued by
manufacturer issued by concerned regulatory People’s republic of China valid till 05/06/2023.
3. Documents for the procurement of API with  Firm has submitted copy of letter from M/s
approval from DRAP (in case of import). Medisave Pharmaceuticals in name of M/s Wimits
Pharmaceuticals for “Approval of Loan” of
Ceftriaxone Sodium.
 Copy of letter No. 3855/2022/DRAP dated
29/March/2022 is submitted where in the
permission to import different APIs including
Ceftriaxone sodium for the purpose of
test/analysis and stability studies is granted.
 Firm has submitted clearance no. E-
533464883684 for 500Kg of Ceftriaxone sodium
issued in name of M.s Medisave by AD I&E
DRAP, Lahore.
4. Data of stability batches will be supported by
attested respective documents like
Submitted
chromatograms,
5. Compliance Record of HPLC software 21CFR
Submitted
& audit trail reports on product testing
6. Record of Digital data logger for temperature
and humidity monitoring of stability chambers Submitted
(real time and accelerated)
Decision: Approved.
The Central Licensing Board in its 284th meeting held on 16-12-2021 has considered and approved the grant
of additional section to M/s Fynk Pharmaceuticals (Pvt.) Ltd., 19 km, G.T. Road, Kalashah Kaku, Tehsil
Ferozwala, District Sheikhupura by way of Formulation vide approval letter No. F. 1-10/2012-Lic dated 7th
June, 2022 with 4 sections including “Dry Powder Injectable (Penicillin) Section”.
338. Name, address of Applicant / Marketing M/s Fynk Pharmaceuticals (Pvt.) Ltd.,
Authorization Holder 19 km, G.T. Road, Kalashah Kaku, Tehsil
Ferozwala, District Sheikhupura.
Name, address of Manufacturing site. M/s Fynk Pharmaceuticals (Pvt.) Ltd.,
19 km, G.T. Road, Kalashah Kaku, Tehsil
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Tazomac Injection 4.5gram
Pharmaceutical ingredient (API) per unit Piperacillin (as Piperacillin Sodium) ……. 4g
Tazobactam (as Tazobactam Sodium) .... 0.5g
Pharmaceutical form of applied drug USP Type-II Glass Vial
Pharmacotherapeutic Group of (API) Antibiotics
Penicillin: Broad-spectrum β-lactam
Tazobactam: Beta-lactamase inhibitor
Reference to Finished product specifications USP Specification
The status in reference regulatory authorities Approved in FDA
(ZOSYN 2.25g Injection)
For generic drugs (me-too status) Tanzo 4.5g Injection by M/s Bosch
Pharmaceutical Pvt. Ltd. Karachi
GMP status of the Finished product New license granted on 14/09/2021.
manufacturer
Address: No. 849, Dongjia Town, Licheng District,
Jinan, Shandong, China
impurities, specifications, analytical procedures and
its verification, batch analysis and justification of
Module III (Drug Substance) The firm is submitted detail of nomenclature,
procedures and its verification, batch analysis and
container closure system and stability studies of drug
substance.
Real time: 30°C ± 2°C / 65% ± 5% RH for 36 months
impurities, specifications, analytical procedure
(including dissolution testing at acidic and buffer
medium) and its verification studies, batch analysis
and justification of specification, reference standard,
product.
dissolution profile against the brand leader by M/s Bosch Pharma
(Batch # PN220071) by performing quality tests.
Analytical method validation/verification of Method verification studies have submitted
product including linearity, range, accuracy, precision,
specificity.
Manufacturer of API Shandong Anxin Pharmaceutical Co. Limited.
Address: No. 849, Dongjia Town, Licheng District, Jinan, Shandong, China
API Lot No. HF1162D3
Description of Pack Tazomac Injection 4.5g is filled in Glass vial USP Type-II further packed in
(Container closure system) unit carton along with patient leaflet insert
Batch No. 001 002 003
Batch Size 500 vials 500 vials 500 vials
No. of Batches 03
1. Reference of previous approval of applications New DML Granted.
2. Approval of API/ DML/GMP certificate of API --

chromatograms, Raw data sheets, COA, summary
data sheets etc.
6. Record of Digital data logger for temperature and Submitted
humidity monitoring of stability chambers (real
time and accelerated)
339. Name, address of Applicant / Marketing M/s Fynk Pharmaceuticals (Pvt.) Ltd.,
Authorization Holder 19 km, G.T. Road, Kalashah Kaku, Tehsil
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Tazomac Injection 2.25gram
Pharmaceutical ingredient (API) per unit Piperacillin (as Piperacillin Sodium) ……. 2g
Tazobactam (as Tazobactam Sodium) .... 0.25g
Pharmaceutical form of applied drug Type-II Glass Vial
Pharmacotherapeutic Group of (API) Antibiotics
Penicillin: Broad-spectrum β-lactam
Tazobactam: Beta-lactamase inhibitor
Reference to Finished product specifications USP Specification
The status in reference regulatory authorities Approved in FDA
(ZOSYN 2.25g Injection)
For generic drugs (me-too status) Tanzo 2.25g Injection by M/s Bosch
Pharmaceutical Pvt. Ltd. Karachi Reg# 039593
GMP status of the Finished product New section granted on 27-12-2021.
manufacturer
Name and address of API manufacturer. Shandong Anxin Pharmaceutical Co.
Limited.
Address: No. 849, Dongjia Town, Licheng District,
Jinan, Shandong, China
Module III (Drug Substance) The firm is submitted detail of nomenclature,
substance.
Real time: 30°C ± 2°C / 65% ± 5% RH for 48 months
product.
dissolution profile against the brand leader by M/s Bosch Pharma
(Batch # PN220030).
specificity.
Manufacturer of API Shandong Anxin Pharmaceutical Co. Limited.
Description of Pack Tazomac Injection 2.25g is filled in Glass vial USP Type-II further packed in
(Container closure system) unit carton along with patient leaflet insert
Batch No. 001 002 003
No. of Batches 03
1. Reference of previous approval of applications New DML Granted.
2. Approval of API/ DML/GMP certificate of API --

data sheets etc.
S.no. Sections Observations Firm’s response

1. 1.6.5 Valid GMP certificate of the drug Copy of DML no.
substance manufacturer issued by the Lu20160009 valid till 09-11-
relevant regulatory authority shall be 2025 issued by CFDA
submitted.
2. 3.2.S.2.2 Manufacturing procedure of drug Firm has referred to the
substance indicate that formulated pre- innovator drug product
mix sterile powder did not contain EDTA, literature approved by US
how you will adjust the quantity of EDTA FDA stating that EDTA is
in the final dispensed powder per vial. only recommended for the
Piperacillin/Tazobactam dry
powder injection filled in
plastic vial.
3. 3.2.S.4.1 Justify for adopting the assay limits Since we are procuring pre-
different from that recommended in the mixed, ready to fill Sterile
USP monograph of Piperacillin and powder of APIs i.e
Tazobactam for injection. Piperacillin and Tazobactam
in (8:1) for which drug
product monograph was not
applied.
4. 3.2.S.4.2  Evidence of availability of HPLC  Testing was performed
system equipped with Auto-sampler with Shimadzu
able to maintain temperature of 5 ± Shimadzu LC 20A
3°, as required by USP monograph, system (Serial No.
shall be submitted. L20305566114,
 Submitted analytical procedure for (Shimadzu, Tokyo,
Assay test mentions the Japan). The system is
determination of “Meropenem” in equipped with a binary
calculation formula. Justification pump (LC-20AD), a
shall be submitted in this regard. temperature controlled
auto-sampler (SIL-
20ACHT), a
temperature-controlled
column compartment
(CTO-20AC) which is
equipped with
thermoelectric Peltier
technology, which has
the ability to maintain
temperature from 2oC to
50oC. Testing was
carried by maintaining
the temperature.
 Documents of HPLC
purchase, installation
and calibration is
submitted
 Firm has submitted
corrected analytical
method.
5. 3.2.S.5 Justify of using Tazobactam pencillamine Tazobactam penicillamine is
as working standard for analysis of drug used during analysis of
substance since you have submitted the related substance to identify
COA of working standard of Tazobactam the peak. Reference standard
Penicillamine, while USP recommends of Tazobactam
simple tazobactam reference standard for penicillamine, is made by DS
assay of drug substance. manufacturer i.e Shandong
Anxin laboratory and it is
used for the identity of peak
and not for the calculation of
impurity assay during the
analysis.
We used Tazobactam
working standard as per USP
monograph for Assay
calculation. COA is
submitted.
6. 3.2.P.1  Justify the composition/strength  Actual weight of

(label claim) of the applied powder in a vial is to be
formulation i.e. 2352mg of pre-mix decided after assay
sterile powder of Piperacillin (as adjustment.
sodium) and Tazobactam (as sodium) Each 2.25g vial provides
and each vial contains a total of piperacillin sodium
2.79mEq (64mg) of sodium per gm of equivalent to 2 grams of
piperacillin and 0.5mg of EDTA in piperacillin and Tazobactam
the combination product with sodium equivalent to 0.25 g
reference to innovator product and of Tazobactam.
submitted label claim. Similarly, each 4.5g vial
provides piperacillin sodium
equivalent to 4grams of
piperacillin and Tazobactam
sodium equivalent to 0.5 g of
Tazobactam.
Mol. Weight of piperacillin

sodium = 539.5
Mol. Weight of piperacillin
sodium = 516.55
Factor of Piperacillin =
1.042
Mol. Weight of Tazobactam
sodium = 322.28
Mol. Weight of Tazobactam
sodium = 300.29
Factor of Tazobactam
=1.073
7. 3.2.P.2.2.1  Justification shall be submitted for  Firm has referred to the
not performing tests of Bacterial performance of sterility
endotoxin, sterility test, particulate testing during stability
matter test and uniformity of dosage studies with acceptable
unit test, as recommended by the USP results.
monograph, during Pharmaceutical
equivalence studies.
8. 3.2.P.2.5 Compatibility studies of the applied Submitted.
formulation with proposed re constitution
diluent shall be submitted.
9. 3.2.P.3.5 Justification shall be submitted for not Firm has referred to the
including all tests as per USP monograph results of impurity testing
in the finished product testing stage of performed by the drug
process validation. substance manufacturer.
10. 3.2.P.5.1  Submit the drug product analytical  Firm has submitted
procedure document from M/s Fynk analytical procedure
Pharmaceuticals instead of document form M/s
submitting the extract of USP Fynk Pharmaceuticals.
monograph.  Testing was performed
 Evidence of availability of HPLC with Shimadzu
system equipped with Auto-sampler Shimadzu LC 20A
able to maintain temperature of 5 ± system (Serial No.
3°, as required by USP monograph, L20305566114,
shall be submitted. (Shimadzu, Tokyo,
 Submitted analytical procedure for Japan). The system is
Assay test mentions the equipped with a binary
determination of “Meropenem” in pump (LC-20AD), a
calculation formula. Justification temperature controlled
shall be submitted in this regard. auto-sampler (SIL-
 Justify the variation in calculation 20ACHT), a
formula from that proposed by USP temperature-controlled
monograph. column compartment
(CTO-20AC) which is
equipped with
thermoelectric Peltier
technology, which has
the ability to maintain
temperature from 2oC to
50oC. Testing was
carried by maintaining
the temperature.
 Evidence of HPLC
purchase, installation
and calibration is
submitted
11. 3.2.P.5.3  Submitted analytical method Specificity by Force
validation protocol declares that degradation was not skipped
specificity test has to be performed because the DS manufacturer
under different conditions like heat, has performed the same.
acid, base, oxidation to see the effects Since we are using ready to
of theses on degradation, whereas no fill powder and no excipient
such performances are evident form are to add. However, we
the submitted analytical method assure that Specificity study
verification report. with force degradation will
 Justification shall be submitted that be performed on commercial
how the “specificity” of the applied batches.
method has been inferred without the
performance of “Peak Purity Test
(e.g., using diode array detector) to
establish that analyte
chromatographic peak is not
attributable to more than one
component”.
12. 3.2.P.6  Justify of using Tazobactam Tazobactam penicillamine is
pencillamine as working standard for used during analysis of
analysis of drug substance since you related substance to identify
have submitted the COA of working the peak. Reference standard
standard of Tazobactam of Tazobactam
Penicillamine, while USP penicillamine, is made by DS
recommends simple Tazobactam manufacturer i.e Shandong
reference standard for assay of drug Anxin laboratory and it is
substance. used for the identity of peak
and not for the calculation of
impurity assay during the
analysis.
 We used Tazobactam
working standard as per
USP monograph for
Assay calculation.
13. 3.2.P.8.3  Clearance certificate or commercial  Firm has submitted
invoice attested by AD I&E DRAP, License to import for 10
Lahore shall be submitted as Kg of Piperacillin
evidence of import of the drug sodium/ Tazobactam
substance. sodium issued by AD
 COAs and complete raw data sheets I&E DRAP, Lahore
wherein details of standard & sample dated 07-04-2022.
solution preparation along with  Submitted.
calculation formula applied for the  To achieve the system
performance stability studies shall be suitability, we use 20µl
submitted for each time point. injection volume as per
 Submitted HPLC chromatograms USP <621>, Method
declare the injection volume as 20µl Verification also has
whereas the USP monograph been conducted for this
recommends the performance of variation.
Assay test with injection volume of
10µl.
Decision: Registration Board approved the applications of “Tazomac Injection 4.5gram” & “S Tazomac
Injection 2.25gram”.
Case no. 03 Registration applications of import cases

a. New Cases (Human)
340. Name, address of Applicant / Importer M/s Gene-Tech Laboratories. B-246, Block 6,
P.E.C.H.S, Karachi, Pakistan
Details of Drug Sale License of importer License No: 002
Address: 246-B, Block 6, P.E.C.H.S, Karachi, Pakistan
Validity: 15-08-2022
Status: by way of wholesaler
Address of Godown: N/A
Name and address of marketing authorization TÜM EKİP İLAÇ A.Ş; Address: İstanbul Tuzla
holder (abroad) Kimya Organize Sanayi Bölgesi, Aromatik Cad.
No.55 34956 Tuzla-İSTANBUL/TURKEY
Name, address of manufacturer(s) TÜM EKİP İLAÇ A.Ş; Address: Tuzla Kimya
Organize Sanayi Bölgesi, Aromatik Cad. No.63 34956
Tuzla-Istanbul/Turkey
Name of exporting country Turkey
Detail of certificates attached (CoPP, Free sale certificate, GMP certificate)
 Firm has submitted original, legalized copy of CoPP certificate (No. 2020/2988) dated 13-10-2020
issued by Republic of Turkey Ministry of health and medical education. 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
13-10-2022.
 Firm has submitted GMP certificate no. 06244 issued by Turkish Medicine & Medical Devices Agency
for M/s
Details of letter of authorization / sole agency agreement
 Firm has submitted copy of letter of authorization from TÜM EKİP İLAÇ A.Ş;Company. The letter
shows that the manufacturer appoints M/s Gene-Tech Laboratories to register and market their products
in Pakistan.
☒ Importer
Intended use of pharmaceutical product ☒ Domestic sale
☐ Export sale
☐ Domestic and Export sales
For imported products, specify one the these ☒ Finished Pharmaceutical product import
☐ Buk import and local repackaging
☐ Buk import and local repackaging for export purpose
only
Details of fee submitted Rs.100,000/- dated 24-03-2021 & Rs.50,000/- dated 05-07-
2021
The proposed proprietary name / brand name Agrabloc 12.5mg/50ml Concentrate Solution for
Infusion
Strength / concentration of drug of Active Each 50ml Vial Contains:
Pharmaceutical ingredient (API) per unit Tirofiban as hydrochloride monohydrate…12.5mg
Pharmaceutical form of applied drug Powder for injection
Pharmacotherapeutic Group of (API) B01AC17

Platelet aggregation inhibitors, except heparin
Reference to Finished product specifications In house
Proposed Pack size 12.5mg/50ml, 1 vial per box
The status in reference regulatory authorities Aggrastat 250mcg/ml injection approved by MHRA of UK
For generic drugs (me-too status) Agraban 12.5mg/50ml of M/s Pharmasol (Reg.106293)
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, batch analysis and justification of
specification, reference standard, container closure system
and stability studies of drug substance and drug product.
Name, address of drug substance manufacturer Farmabios S.p.A. Via Pavia, 1 27027 Gropello Cairoli,
(PV) Italy
Module-III Drug Substance: Firm has submitted detailed data for drug substance data
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 The accelerated stability study data is conducted at 40 oC
(Conditions & duration of Stability studies) ±2oC / 75% ± 5% RH for 6 months.
The real time stability data is conducted at 25oC ± 2oC and
60% ± 5% for 48 months.
description, composition, pharmaceutical development,
manufacture, manufacturing process and process control,
process validation report, 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 Comparative Comparative analysis Studies against the reference product
Dissolution Profile of Caelyx injection has been submitted.
Analytical method validation/verification of Firm has submitted analytical method verification studies
product of the drug product.
Container closure system of the drug product AGRABLOC 12.5 mg/50 ml IV Concentrate Solution For
Infusion is packed with the following primary packaging
materials: - 50 ml colorless Type I glass vial - 20 mm
bromobutyl red rubber stopper - 20 mm flip-off cover
AGRABLOC is supplied as 1 vial with a PIL in box
containing approved text, batch number and expiration
date.
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 40 ±
2°C, 75 % ± 5 % R.H for 6 months.
The real time stability study data is conducted at 30 ± 2°C,
75 % ± 5 % R.H for 24 months.

1.3.3 Submit original valid legalized GMP certificate
of drug product manufacturer and COPP of
applied product issued by relevant regulatory
1.3.5 Copy of valid DSL of the applicant shall be
submitted.
3.2.P.2.1 Submit drug-excipient compatibility studies
since qualitative composition of applied
formulation is different from that of the
innovator drug product. Moreover Clarification
shall be submitted regarding inclusion of
mannitol in master formulation since innovator
drug product does not contain it.
3.2.P.2.2.1 Justification shall be submitted for the limit &
results of pH test applied in Pharmaceutical
equivalence studies with reference to
pharmacopoeial monograph.
3.2.P.3.3 Justification shall be submitted for not
performing terminal sterilization.
3.2.P.8.3  Long term stability studies on Zone-IV
conditions till claimed shelf life shall be
submitted for three batches
Decision: Registration Board deferred the case for submission of reply to the above cited shortcomings.
b. Deferred cases
341. Name, address of Applicant / Importer M/s Biocare Pharmaceutica 807 Shdman-I, Lahore.
Details of Drug Sale License of importer DSL No.: 05-352-0063-032069D
Address: Biocare pharamceutica 80 shadman-I district
Lahore.
Validity: 17/04/2022
Status: License to sell drugs as Distributor
Name and address of marketing M/s Northeast Pharmaceutical Goup Shenyang No. 1
authorization holder (abroad) Pharmaceutical Co., Ltd., N0.8, Kunminghu street, Economic
& Technological development zone, Shenyang, Liaoning
Name, address of manufacturer(s) M/s Northeast Pharmaceutical Group, Shenyang No. 1
Pharmaceutical Co., Ltd., No. 8, Kun Ming Hu street,
Economic & Technological Development zone, Shenyang,
Exporting country China
 Original legalized CoPP (certificate No. 20190072) issued by Liaoning Medical Products
Administration valid till 29/07/2020. The product is available for free sale in the market of exporting
country. The facilities and operations conform to Chinese-GMP.
 Legalized GMP certificate (No. LN20180007) valid till 25/03/2023.
 Copy of sole agency agreement is submitted whereby M/s Biocare pharmaceutica is appointed as a
distributor for the applied product.
☒ Importer
Status of application ☒ New Drug Product (NDP)
☐ Generic Drug Product (GDP)
☐ Export sale
☐ Buk import and local repackaging for export purpose only
Dy. No. and date of submission Dy. No 30397 Dated 13/11/2020
Details of fee submitted Rs. 50,000/- Dated 20/08/2020 (1925409)
Rs. 50,000/- dated 23/09/2020 (1925466)
The proposed proprietary name / brand name Fosofix Injection 4gm
Alternate brand name:
Fonyl
Fosfix
Pharmaceutical ingredient (API) per unit Fosfomycin as disodium……..4gm
(equivalent to Fosfomycin disodium……5.28g)
Pharmaceutical form of applied drug Powder for solution for intravenous injection
Pharmacotherapeutic Group of (API) Antibacterial
Proposed unit price Rs. 1700/-
The status in reference regulatory authorities Fosfomycin 40mg/ml powder for solution for infusion (4gm)
by M/s Infectopharm, MHRA approved.
For generic drugs (me-too status) Fosfomycin injection 4gm by M/s Efroze KHI, R.No.004722
Module-II (Quality Overall Summary) Submitted.
Name, address of drug substance M/s Northeast Pharmaceutical Group Co., Ltd., 29 Shenxi
manufacturer Liudong road, Shenyang Economic and Technical
Development zone, China.
(GMP certificate No. LN20190041 valid till 15/07/2024)
Module-III Drug Substance: Submitted
Stability Studies of Drug Substance  36 months real time stability data at 30°C ± 2°C / 65% ±
(Conditions & duration of Stability studies) 5%RH of 03 batches
 06 month accelerated stability data 40°C ± 2°C / 75% ±
5%RH of 03 batches
Module-III Drug Product: Submitted.
Pharmaceutical Equivalence and Pharmaceutical equivalence has been established by
Comparative Dissolution Profile conducting all the quality tests against the reference product,
Fosmicin-S manufactured by M/s Meiji Seka Kaisha ltd,
Japan.
Analytical method validation/verification of COAs: 10119030002, 10119030003, 10119030.
product
Container closure system of the drug product Injection vials made up of molded soda lime glass, rubber
stopper and aluminium -plastic laminated cap
Stability study data of drug product, shelf life  18 months real time stability data at 30°C ± 2°C / 75% ±
and storage conditions 5%RH of 03 batches
5%RH of 03 batches
Evaluation by PEC-I:
 The product in reference country in approved with a primary packaging of 100ml glass bottle while the
volume of vial of the applied product is 30ml.
 The firm has submitted Original, legalized and vlaid CoPP (certificate No. 20210027) issued by Liaoning
Medical Products Administration valid till 07/01/2023. The product is available for free sale in the market
of exporting country. The facilities and operations conform to Chinese-GMP.
 Analytical method verification studies for API performed by drug product manufacturer are not submitted.
The firm has stated that the API testing was conducted as per Chinese Pharmacopoeia therefore verification
studies are not required. Moreover, the official monograph for API is present in British Pharmacopoeia.
Decision of 308th meeting:
Deferred for of following points;
Clarification since the product in reference country in approved with a primary packaging of 50ml glass bottle
while the volume of vial of the applied product is 30ml.
Submission of analytical method validation/verification studies of drug substance performed by drug product
manufacturer.
Submission of real time stability study data according to the conditions of zone IV-A of 03 batches till shelf life
since the submitted data is of 18 months only.
 The firm has provided the following reference of the product which is approved with 30ml volume of the
vial which is in-lined with the volume of the vial of the applied product.
Ivozfo (Fosfomycin for injection) (2g, 4g, 8g) by M/s Verity Pharmaceuticals, Ontario, Health Canada
Approved.
https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=97819 (accessed on 12/11/2021 at

7pm)
 As per MHRA, Water for Injections and Glucose Infusion 50 mg/ml (5 %) or Glucose Infusion 100 mg/ml
(10 %) may be used as solvent for the reconstitution and dilution while according to HealthCanada, 5%
dextrose solution must be used. Whereas both the authorities recommend that Sodium chloride containing
solvents must not be used.
 Reconstitution: (MHRA, Ireland & Health Canada)
Shake the vial prior to the reconstitution to loosen up the powder. Reconstitute the 2 g or 4 g vials with
20ml solvent.
 Dilution (MHRA, Ireland & Health Canada)
Transfer the reconstituted contents of 2 g vials into an infusion container with further 30 ml of solvent.
Transfer the reconstituted contents of 4 g vials into an infusion container with further 80 ml of solvent.
 The firm has submitted analytical method validation studies for Fosfomycin including precision, accuracy,
linearity and specificity. The validation studies for impurities have also been submitted.
 The firm has submitted stability data with the following details;
24 months real time stability data at 30°C ± 2°C / 75% ± 5%RH of 03 batches
06 month accelerated stability data 40°C ± 2°C / 75% ± 5%RH of 03 batches
Batches: 4190406, 4190407, 4190408
 As per the provided data, the in-use after reconstitution with 5% and 10% dextrose solution for 12 hours.
 The applied product is developed and tested according to In-House specifications while the official
monograph of the product is available in J.P. The comparison of In-house and J.P specificaytions are given
below.
Test Limits defined by J.P In-house limits
pH 6.5-8.5 6.5-8.5
Fosfomycin sodium Test not performed ≤ 1%
diol (impurity A)
Clarity of solution Clear and colorless Clear and colorless
Should not be more pronounced than
the reference suspension 1.
Any color produced should not be
more intense than reference solution
yellow 1.
Water ≤ 4% ≤ 2%
Bacterial Less than 0.025EU/mg Less than 0.033EU/mg
endotoxins
Visible particles clear and free from foreign Absent
insoluble matters
(foreign insoluble matter)
Particulate matter ≤ 6000/container (≥10um) ≤ 6000/container (≥10um)
≤ 600/container (≥25um) ≤ 600/container (≥25um)
Weight variation Should meet the requirement ±5%
<6.02>
Assay 90-110% 90-110%
Cylinder plate method Cup plate method
Test Organism: Proteus Sp. Test Organism: Micrococcus Luteus
Nephelometry test (parallel lines
method)
Test Organism: Escheritia Coli
Decision of 313th meeting: The Board deliberated that the specifications limits as defined by Japanese
Pharmacopoeia are more stringent and tighter than the established In-House specification as well as the method
used for the testing of the applied product are also different from the method developed In-House. Therefore, the
Board decided to defer the case and directed the firm to submitted all the relevant data according to the the
monograph present in Japanese Pharmacopoeia.
Firm’s response: According to our manufacture they recently adapted EP10.0/Innovator Standard Specification
based upon International UK, Canada and Europe Fosfomycin Sodium 4 gm brands Standard. In UK, Europe and
Canada they follow EP 1.0/Innovator standard instead of JPXVIL. Even in Bangladesh for Fosfomycin Sodium 4
gm they follow EP/Innovator standard. So, based upon European Pharmacopeia 10.0/Innovator standard of
UK/German approved brand FOMICYT 4 GM (Infecto Pharm, Germany), Canada IVOZFO 4 GM (Verity
Pharmaceuticals, Canada) & FOSFOCINE IV 4 gm Sanofi Aventis, France, our Manufacture Fosfomycir Sodium
4 gm follow EP 10.0/Innovator standard Overall our manufacturer (Northeast Pharmaceutica Group) current
Fosfomycin Sodium 4 gm Sterile Powder vial follow EP10.0/Innovator
Decision: Deferred for submission of product development and stability studies data as per Japanese
pharmacopeoia monograph of “Fosfomycin for injection”.
342. Name, address of Applicant / Importer M/s The Schazoo Pharmaceutical Laboratories (Pvt.) Ltd.
Kalalwala Stop, 20Km Lahore- Jaranwala Road, District
Sheikhupura, Pakistan.
Details of Drug Sale License of importer License No: 05-354-0076-059245D
Address: Kalalwala Stop, 20Km Lahore- Jaranwala Road,
District Sheikhupura, Pakistan.
Status: License to sell drugs as distributor
Renewal: Firm has submitted a receipt of renewal but it does
not contain any date
Name and address of marketing M/s BDR Pharmaceuticals International Pvt. Ltd
authorization holder (abroad) R.S.No. 578, Near Effluent Channel Road, Village: Luna,
Ta: Padra, Dist : Vadodara– 391 440, (India).
Name, address of manufacturer(s) M/s BDR Pharmaceuticals International Pvt. Ltd
R.S.No. 578, Near Effluent Channel Road, Village: Luna,
Ta: Padra, Dist : Vadodara– 391 440, (India).
Name of exporting country India
Detail of certificates attached (CoPP, Free CoPP: Firm has submitted original, legalized CoPP
sale certificate, GMP certificate) certificate (No. 022105) valid till 07-11-2019 issued by Food
& Drugs Control Administration, Gujarat, India. The CoPP
confirms free sale status of the product in exporting country
as well as GMP status of the manufacturing site through
Details of letter of authorization / sole Firm has submitted letter of authorization certificate from
agency agreement M/s BDR Pharmaceuticals International Pvt. Ltd
☒ Importer
☐ Export sale
For imported products, specify one the ☒ Finished Pharmaceutical product import
these ☐ Buk import and local repackaging
Details of fee submitted PKR 75,000/- dated 13-04-2022
The proposed proprietary name / brand Arbit Tablets USP 500mg
name
Pharmaceutical ingredient (API) per unit Abiraterone acetate …………… 500mg
Pharmacotherapeutic Group of (API) Other hormone antagonists and related agents
Reference to Finished product USP
specifications
The status in reference regulatory ZYTIGA 500 mg Janssen-Cilag International NV
authorities USFDA Approved.
For generic drugs (me-too status) --
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.
Name, address of drug substance BDR Life Sciences Private Limited R.S.NO.578, Near
manufacturer Effluent, Channel Road, Village Luna – 391 440, Ta.Padra,
Dist. VADODARA, India
Module-III Drug Substance: Firm has submitted detailed drug substance data for both
sources related to nomenclature, structure, general properties,
specifications, analytical procedures and its validation, batch
analysis and justification of specification, reference standard,
substance.
Stability Studies of Drug Substance Firm has submitted stability study data of 3 batches The
(Conditions & duration of Stability studies) 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 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 studies against the innovator
Comparative Dissolution Profile product of Zytiga tablet 250mg while CDP studies have bene
performed in three dissolution mediums of pH 1.2, 4.5 & 6.8
against the Zytiga 250mg tablet.
Analytical method validation/verification Firm has submitted analytical method validation studies for
of product the applied product as per USP monograph.
Container closure system of the drug HDPE Container
product
Stability study data of drug product, shelf Firm has submitted stability study data of 3 batches The
life and storage conditions 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 36
months.
Section# Observation
1.1 Fee for registration has been submitted from header of DML instead of DSL.
Submit valid copy of DSL.
1.3 Submit original legalized valid COPP since the submitted COPP was expired at the
time of submission of registration application.
Submit evidence of approval for the required manufacturing facility “Tablet
(steroid)” for the applied formulation.
3.2.P.2.2.1 Submit justification for performing Pharmaceutical equivalence studies against the
Zytiga 250mg tablet while the applied strength is 500mg.
Decision of 324th meeting: Registration Board was apprised that the letter of shortcoming has been initially
issued to the firm, hence Board deferred the case for submission of reply to the above cited shortcomings within
six months.
Firm’s response: Firm has submitted following vide their letter no. ref; SPL/BDR/3147 vide R&I dated 21-06-
2023.
Section# Observation Firm’s response
1.1 Fee for registration has been submitted from Not submitted
header of DML instead of DSL.
Submit valid copy of DSL.
1.3 Submit original legalized valid COPP since Original Legalized COPP no. MFG/WHO
the submitted COPP was expired at the time GMP/COPP/2023/1951221591 issued by
of submission of registration application. food 7 Drugs Control Administration,
Submit evidence of approval for the Gujarat, with following particulars:
required manufacturing facility “Tablet  Product license holder: M/s BDR
(steroid)” for the applied formulation. Pharmaceuticals International Pvt. Ltd
R.S.No. 578, Near Effluent Channel
Road, Village: Luna, Ta: Padra, Dist :
Vadodara– 391 440, (India).
 Free sale status in country of origin
(India): Yes.
 GMP status of the manufacturer
endorsed: Yes.
 Validity: 09-01-2026
Firm has also submitted copy of GMP

certificate no. 1711454 (valid till 07-11-
2019) issued by Food & Drugs Control
Administration in name Of M/s BDR
Pharmaceuticals International Pvt. Ltd
R.S.No. 578, Near Effluent Channel Road,
Village: Luna, Ta: Padra, Dist : Vadodara–
391 440, Gujarat State (India) declaring
availability of Tablet & Capsule
(Cytotoxic) section.
3.2.P.2.2.1 Submit justification for performing We BDR Pharmaceutical In. pvt. Ltd
Pharmaceutical equivalence studies against hereby justify that the Bioequivalence
the Zytiga 250mg tablet while the applied study with the title “A randomized open
strength is 500mg. label balanced two period two sequence
single dose two way crossover oral
bioequivalence study of our Arbiraterone
acetate 500mg tabklets of BDR
Pharmaceutical international pvt. Ltd
compare with Zytiga 250mg tablets of
Janssen biotech inc., Horsham at a dose of
500mg (2 / 250mg) in a 36 healthy human
adult male subjects under fasting
conditions has started on Jan 2017 and
completed on 02-02-2017 and complete
don 02-02-2017. At the time of BE Study
for Arbirtaerone tablet USP only Zytiga
250mg (N202379 001) HAS LISTED AS
Rld IN ORANGE BOOK. Zytiga 500mg
tablets has listed as RLD in Apr, 14, 2017.
Therefore we selected the Zytiga 250mg as
RLD against of the Arbirtaerone tablets
500mg.
Decision: Deferred for following:
 Full fee of registration from the head of Drug Sale License.
 Pharmaceutical equivalence and CDP studies against the relevant strength i.e., 500mg of the
Innovator drug product.
 Further deliberation regarding requirement of manufacturing facility for applied formulation.
343. Name, address of Applicant / Importer M/s Himmel Pharmaceuticals (Pvt) Ltd., 793-D, Block C, Faisal
Town, Lahore.
Details of Drug Sale License of DSL No.: 05-352-0065-016174D
importer Address: Himmel Pharmaceuticals (Pvt) Ltd 793 D, Block C,
Faisal Town, District Lahore.
Godown: N/A
Status: License to sell drugs as a Distributor
Name and address of marketing M/s Beacon Pharmaceuticals Limited,
authorization holder (abroad) Office Address: 9/B/2, Toyenbee Circular road, Motijheel, Dhaka,
Bangladesh.
Plant Address: Kathali, Bhaluka, Mymensingh Bangladesh.
Name, address of manufacturer(s) M/s Beacon Pharmaceuticals Limited,
Office Address: 9/B/2, Toyenbee Circular road, Motijheel,C/A
Dhaka-1000, Bangladesh.
Exporting country Bangladesh
 Original legalized CoPP (certificate No. DA/6-110/2016/3288) issued by Directorate General of Drug
Administration on 01/06/2020.
The applied product is available in market of exporting country for free sale.
The facilities and operations conform to WHO-GMP.
 Copy of GMP certificate No. DA/6-11-/06/4950 dated 17/07/2019 on the basis of inspection conducted
on 07/07/2018 (expired).
 Copy of letter of authorization is submitted whereby M/s Himmel Pharmaceuticals is authorized to
register and sell different products including Cobazanix capsule (20mg & 80mg).
☒ Importer
☐ Export sale
only
Details of fee submitted Rs. 50,000/- Dated 10/12/2020
The proposed proprietary name / brand name Cabozanix 20mg Capsule
Pharmaceutical ingredient (API) per unit Cobazanitinib as S-Malate……20mg
Pharmaceutical form of applied drug Immediate release hard gelatin capsule
Pharmacotherapeutic Group of (API) Anti-cancer
The status in reference regulatory authorities Cometriq Capsule (20mg, 80mg) by Ipsen Pharma,
EMA approved.
nomenclature, structure, general properties, solubilities,
physical form, manufacturers, description of
batch analysis and justification of specification,
reference standard, container closure system and
stability studies of drug substance and drug product is
submitted.
Name, address of drug substance manufacturer M/s Beijing Mesochem Technology Co., Ltd., Floor 23,
Building 9, Lippo Plaza, Economic and technological
Development zone Beijing (GMP certificate not
provided).
Module-III Drug Substance: The API used belongs to BCS class II. The firm as
submitted detail of nomenclature, structure, general
properties, solubilities, physical form, manufacturers,
impurities, specifications, analytical procedures and its
Stability Studies of Drug Substance  24 months real time stability data at 25°C ± 2°C /
(Conditions & duration of Stability studies) 60% ± 5%RH of 03 batches
 06 month accelerated stability data 40°C ± 2°C /
75% ± 5%RH of 03 batches
(150528, 150712, 150925)
Module-III Drug Product: Batch analysis (3590002, 3590003, 3590004)
Detail of manufacturers, description of manufacturing
process and controls, impurities, specifications,
analytical procedures and its validation, batch analysis
product is submitted.
Pharmaceutical Equivalence and Comparative CDP against the reference product, Cometric 20mg
Dissolution Profile Capsule by M/s Ipsen Pharma, France (EMA
Approved) is submitted with acceptable values of f1
and f2. (Batch number C22001).
Analytical method validation/verification of Data of analytical method validation is submitted
product including, specificity, accuracy, ruggedness, precision
and linearity etc for assay of API. (validation studies of
analytical method for related substance have submitted
as well.
Container closure system of the drug product HDPE pot with srew cap, induction sealable wad
containing 90 capsules along with silica gel, packed in
secondary outer carton.
Stability study data of drug product, shelf life and Batches: (3590002, 3590003, 3590004)
storage conditions Batch size: 10,000 capsules
 24 months real time stability data at 30°C ± 2°C /
The drug substance manufacturer is M/s Beijing Mesochem Technology Co., Ltd., China. The submitted GMP
certificate is of M/s Kaifeng Pharmaceutical (group) Co., Ltd., China. The applicant has submitted a letter form
M/s Beijing Mesochem Technology Co., Ltd., China stating;
“We Beijing Mesochem Technology Co., Ltd., certiifctae that Beijing Mesochem is a manufacturer. According to
cooperation agreement currently, Beijing Mesochem tehnology Co., ltd., is manufacturing at Kaifeng
Pharmaceutical (group) co., Ltd.,. as per the agreement enclosed. We guarantee the site equivalence and
analytical/product equivalence”.
Observation Response
Since the excipients used in the manufacturing of the The excipients used comply to current
product are different from the excipients used in pharmacopoeial monograph (BP). These
manufacturing of reference product, therefore, excipients are pharmaceutically inert substances
compatibility study of the excipients with API is and These excipients are used below “Inactive
required to be performed. The information should be Ingredient Guide” limit of FDA. Extensive
presented under relevant section in module II and analysis of the product is done and satisfactory
module III. results of assay, dissolution and impurity profile
are obtained.
Test for Genotoxic impurities in addition to impurity Not responded
profiling, is included in the final specifications of the
reference product while the test is not included in the
specifications of the applied product, please clarify.
As per EMA assessment report of the innovator’s Not responded
product, the testing specification for Drug Substance
include tests for malic acid content, organic volatile
impurities, genotoxic impurities, crystal form, particle
size distribution and percentage purity as well while
the testing specifications for Drug Substance used for
the manufacturing of the applied product do not
include the above-mentioned tests, please explain.
Moreover, a discussion shall be provided on the
inclusion of certain tests, evolution of tests, analytical
procedures and acceptance criteria with reference to
above query under relevant sections in Module II and
Module III.
Pharmaceutical equivalence of the applied product is The firm has submitted copy of clarification letter
established against the innovator’s product Cabometyx from M/s Beacon Pharmaceuticals Limited.
capsule by Ipsen Pharma France as per the submitted “Cabometyx and Cometriq are two brand name
dossier, while Cabometyx by Ipsen Pharma, France is drugs that both contain the same active ingredient
not actually Capsule dosage form. The mentioned of Cabozanitinib by Ipsen Pharma, France. While
brand name that is Cabometyx is film coated tablet as Cabometyx is film coated tablet and Cometriq is
per the information provided on the official website of Capsule dosage form as per the information
ANSM, France, please clarify. provided on EMc. During Bio-equivalence studies
of Cabozanix 20mg Capsule, Cometriq Capsuel
(B/NC21801) used as reference product”.
Scientific justification for the use of 1% overage in the Not responded
formulation is required.
Previous Decision of 313th meeting: Deferred for the following;
 Submission of impurity profiling as per the innovator’s product including the detail of testing of genotoxic
impurities.
 Justification for not performing certain tests which include malic acid content, organic volatile impurities,
genotoxic impurities, crystal form, particle size distribution and percentage purity for drug substance.
 Scientific justification for the use of 1% overage in the formulation
344. 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 DSL No.: 05-352-0065-016174D
Address: Himmel Pharmaceuticals (Pvt) Ltd 793 D, Block C,
Faisal Town, District Lahore.
Godown: N/A
Status: License to sell drugs as a Distributor
Name and address of marketing M/s Beacon Pharmaceuticals Limited,
authorization holder (abroad) Office Address: 9/B/2, Toyenbee Circular road, Motijheel,
Dhaka, Bangladesh.
Name, address of manufacturer(s) M/s Beacon Pharmaceuticals Limited,
Office Address: 9/B/2, Toyenbee Circular road, Motijheel,C/A
Dhaka-1000, Bangladesh.
Exporting country Bangladesh
 Original legalized CoPP (certificate No. DA/6-110/2016/3289) issued by Directorate General of Drug
Administration on 01/06/2020.
The applied product is available in market of exporting country for free sale.
The facilities and operations conform to WHO-GMP.
 Copy of GMP certificate No. DA/6-11-/06/4950 dated 17/07/2019 on the basis of inspection conducted
on 07/07/2018 (expired).
 Copy of letter of authorization is submitted whereby M/s Himmel Pharmaceuticals is authorized to
register and sell different products including Cobazanix tablet 60mg.
☒ Importer
☐ Export sale
only
Details of fee submitted Rs. 50,000/- Dated 10/12/2020
The proposed proprietary name / brand name Cabozanix 60mg tablet
Pharmaceutical ingredient (API) per unit Cobazantinib as S-Malate……20mg
Pharmaceutical form of applied drug Immediate release film coated tablet
Pharmacotherapeutic Group of (API) Anti-cancer
The status in reference regulatory authorities Cabometyx tablet (20mg, 40mg, 60mg) by M/s Ipsen
Pharma EMA Approved.
submitted.
Name, address of drug substance manufacturer M/s Beijing Mesochem Technology Co., Ltd., Floor 23,
Building 9, Lippo Plaza, Economic and technological
Development zone Beijing (GMP certificate not
provided).
Module-III Drug Substance: The API used belongs to BCS class II. The firm as
submitted detail of nomenclature, structure, general
Stability Studies of Drug Substance  24 months real time stability data at 25°C ± 2°C /
(Conditions & duration of Stability studies) 60% ± 5%RH of 03 batches
Module-III Drug Product: Batch analysis (3850002, 3850003, 3850004)
Detail of manufacturers, description of manufacturing
product is submitted. The dissolution specifications are
as per USFDA dissolution method available online.
Pharmaceutical Equivalence and Comparative The firm has performed Pharmaceutical Equivalence
Dissolution Profile against the innovator’s product, Cabometyx 60mg
tablet by M/s Ipsen Pharma, France (EMA approved)
(Batch number C91801).
CDP against the reference product, Cabometyx 60mg
tablet by M/s Ipsen Pharma, France (EMA Approved)
is submitted. (Batch number C22001).
Analytical method validation/verification of Data of analytical method validation is submitted
product including, specificity, accuracy, ruggedness, precision
and linearity etc for assay of API. (validation studies of
analytical method for related substance have submitted
as well.
Container closure system of the drug product HDPE bottle with srew cap and induction sealable wad
and silica gel containing 30 tablets packed in secondary
outer packaging.
Stability study data of drug product, shelf life and Batches: (3850002, 3850003, 3850004)
storage conditions Batch size: 6666 tablets
 24 months real time stability data at 30°C ± 2°C /
The drug substance manufacturer is M/s Beijing Mesochem Technology Co., Ltd., China. The submitted GMP
certificate is of M/s Kaifeng Pharmaceutical (group) Co., Ltd., China. The applicant has submitted a letter form
M/s Beijing Mesochem Technology Co., Ltd., China stating;
“We Beijing Mesochem Technology Co., Ltd., certiifctae that Beijing Mesochem is a manufacturer. According to
cooperation agreement currently, Beijing Mesochem tehnology Co., ltd., is manufacturing at Kaifeng
Pharmaceutical (group) co., Ltd.,. as per the agreement enclosed. We guarantee the site equivalence and
analytical/product equivalence”.
Observation Response
Since the qualitative composition of the applied product is The excipients used comply to current
different from the innovator/reference product, therefore, pharmacopoeial monograph (BP & USP). These
compatibility studies of the excipients with the drug excipients are pharmaceutically inert substances
substance is required. The information should be and These excipients are used below “Inactive
presented under relevant section in module II and module Ingredient Guide” limit of FDA. Extensive
III. analysis of the product is done and satisfactory
results of assay, dissolution and impurity profile
are obtained.
Justify the manufacturing process of the applied product “As per Beacon’s manufacturing process, Direct
since it is a type of direct compression method while the compression method is used and the process is
reference product is manufactured by wet granulation validated”.
method.
Test for Genotoxic impurities in addition to impurity Not responded
profiling is including in the final specifications of the
reference product while the test is not included in the
specifications of the applied product, please clarify.
As per EMA assessment report of the innovator’s product, Not responded
the testing specification for Drug Substance include tests
for malic acid content, organic volatile impurities, crystal
form, particle size distribution and percentage purity as
well while the testing specifications for Drug Substance
used for the manufacturing of the applied product do not
include the above-mentioned tests, please explain.
Moreover, a discussion shall be provided on the inclusion
of certain tests, evolution of tests, analytical procedures
and acceptance criteria with reference to above query
under relevant sections in Module II and Module III.
Decision of 313th meeting: Deferred for the following;
 Submission of impurity profiling as per the innovator’s product including the detail of testing of genotoxic
impurities.
 Justification for not performing certain tests which include malic acid content, organic volatile impurities,
genotoxic impurities, crystal form, particle size distribution and percentage purity for drug substance.
 Submission of relevant data for drug substance as per the GUIDANCE DOCUMENT FOR SUBMISSION
OF APPLICATION ON FORM 5-F FOR REGISTRATION OF PHARMACEUTICAL DRUG
PRODUCTS FOR HUMAN USE available on the official website of DRUG REGULATORY
AUTHORITY OF PAKISTAN.
 Clarification since the GMP certificate of M/s Kaifeng Pharmaceutical (group) Co., Ltd., China is
submitted while as per submitted dossier the manufacturer of drug substance is M/s Beijing Mesochem
Technology Co., Ltd., China and the relevant data related to drug substance is submitted from M/s Beijing
Mesochem Technology Co., Ltd., China.
Firm’s response: Firm has submitted following:
 Declaration form M/s Beijing Mesochem Technology Co., Ltd that Cabozanitinib malate is free of
genotoxic impurities and organic solvents.
 Declaration form M/s Beijing Mesochem Technology Co., Ltdis a manufacturer. Acoridng to cooperation
agreement currently Beijing Mesochem manufacture at Kaifeng Pharmaceutical (group) Co. ltd as per the
agreement. We guarantee the site equivalence and analytical/product equivalence.
 COA of drug substance including tests of malic acid content, percentage purity and bulk density.
Decision: Registration Board approved the applications of “Cabozanix 20mg Capsule” & “Cabozanix 60mg
Capsule” as per policy of inspection of manufacturer abroad.
Case no. 04. The Authority in its 165th meeting held on 20th July, 2023 approved
the out of Que consideration of Form 5-F applications of the following molecules
received till 31st December, 2023, keeping in view of their repeated shortage/non-
availability reports in the market and to ensure timely access of these drugs to
public.
1. labetalol injection
2. Calcium gluconate injection
3. Digoxin injection
4. Propofol injection
5. Cholestyramine powder/sachet
6. Lithium Carbonate Tablet
7. Pilocarpine Eye Drops
8. Heparine Injection
9. Divalproex sodium Tablet and injction
10. Anti-D injection
11. Streptokinase injection
12. Octreotide acetate injection
13. Carbamazepine tablet
14. Penicillin-G Benzathine injection
15. Fucidic acid cream
16. Calcitonin injection
In compliance to the Authority decision mentioned above the following applications were considered by
the board after due evaluation.
345. Name, address of Applicant / Marketing M/s Mediate Pharmaceutical (PVT.) LTD. Plot
Authorization Holder No:-150-151, Sector 24, Korangi Industrial Area,
Karachi Pakistan.
Name, address of Manufacturing site. M/s Mediate Pharmaceutical (PVT.) LTD. Plot
No:-150-151, Sector 24, Korangi Industrial Area,
Karachi Pakistan.
☐ Importer
GMP status of the firm Last inspection of M/s Mediate Pharmaceuticals
conducted on 10.05.2022 declaring GMP status as
good.
dated 15th -09-2021 specifying Tablet (General)
section.
☐ Export sale
The proposed proprietary name / brand name Epimed DR Tablet 500mg
Pharmaceutical ingredient (API) per unit
Divalproex sodium eq. to Valproic acid…….
500mg
Containing 538.2 mg of valproate semisodium* per

tablet (equivalent to 500 mg of valproic acid).
*Valproate semisodium is a stable coordination

compound comprised of sodium valproate and
valproic acid in a 1:1 molar relationship. It is also
known as divalproex sodium (USAN).
Pharmacotherapeutic Group of (API) Psycholeptics, Antipsychotics, Other
Antipsychotics, ATC code: N05AX.
Pharmaceutical form of applied drug Yellow colored enteric coated oblong shape tablet
plain from both sides.
The status in reference regulatory authorities Approved by US FDA
For generic drugs (me-too status) Dipodium 500mg Tablet of M/s Amarant
Pharmaceutical Pvt. Ltd. (Reg.No:058621)
Name and address of API manufacturer. M/s Sun Pharmaceutical Industries Ltd.Sathammai
Village, Karunkuzhi Post, Madhuranthagam Taluk,
Kancheepuram District, Tamilnadu - 603 303,
India.
solubilises, physical form, manufacturers,
drug product.
drug substance.
30°C ± 2°C / 65% ± 5% RH for 72 months.
Depakote tablet 500mg manufactured by Schering
–Plough Corporation.
against the innovator’s product Depakote Tablet
500mg in 3 dissolution medias.
product.
Manufacturer of API M/s Sun Pharmaceutical Industries Ltd.Sathammai Village, Karunkuzhi Post,
Madhuranthagam Taluk, Kancheepuram District, Tamilnadu - 603 303,
India.
API Lot No. DVLNF20085
Description of Pack
Alu-Alu Blister
Batch No. MD/EM-01 MD/EM-02 MD/EM-03
No. of Batches 03
1. Reference of previous approval of applications N/A
attested respective documents like chromatograms, testing for stability studies
humidity monitoring of stability chambers (real temperature and humidity monitoring of real time
time and accelerated) and accelerated stability chambers.

1.6.5 Submit valid GMP certificate/ DML of the drug Firm has submitted copy of
substance manufacturer. Certificate# 16478/D1/4/2021
issued by Department of Food
Safety & Drugs Control
Administration, Government
of Tamil Nadu, valid upto 31-
12-2024.
3.2.P.2.2.1 Submit comparative dissolution profile along Submitted
with f2 factor calculation
3.2.P.8.3 Submit documents confirming import of drug Firm has submitted copy of
substance issued by DRAP I&E office. loan letter from Wimits
Pharmaceuticals for 2Kg of
Divalproex sodium along with
import documents issued by
DRAP I&E Lahore.
2.3.R.1 Submit complete batch manufacturing record for Submitted
stability batches.
Decision: Approved
346. Name, address of Applicant / Marketing M/s Wimits Pharmaceuticals (Pvt) Ltd. Lahore
Authorization Holder 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
Evidence of manufacturing facility GMP Certificate No.70/2021-DRAP(FID/2061717-
540) Dated 08-09-21 declares availability of tablet
general section
GMP status of the Finished product GMP Certificate No.70/2021-DRAP(FID/2061717-
manufacturer 540) Dated 08-09-21
☐ Export sale
The proposed proprietary name / brand name Dpiro 500mg CR tablet
Strength / concentration of drug of Active Each Extended Release tablet contains:

Pharmaceutical ingredient (API) per unit Divalproex sodium equivalent to Valproic
acid………....500mg
Pharmaceutical form of applied drug Extended Release Tablet
Pharmacotherapeutic Group of (API) Antiepileptic
The status in reference regulatory authorities Depakote ER 500mg tablet USFDA Approved.
For generic drugs (me-too status) Towprox CR 500mg tablet of M/s Crystolite
(Reg.#087346).
Name and address of API manufacturer. M/s Sun Pharmaceutical Industries Ltd
Address: Sathammai Village, Karunkuzhi Post,
Madhuranthagam Taluk, Kancheepuram District,
Tamilnadu – 603 303, India.
specifications, analytical procedures and its verification,
submitted.
Module III (Drug Substance) The firm as submitted detail of nomenclature, structure,
general properties, solubilities, physical form,
manufacturers, description of manufacturing process
and controls, tests for impurity, specifications,
analytical procedures and its verification, batch analysis
substance
Real time: 30°C ± 2°C / 65% ± 5%RH for 72 months
Batches: (PDMDVLFL183, PDMDVLFL184,
PDMDVLFL185)
medium) and its verification studies, batch analysis and
product.
dissolution profile against the brand leader that is EPIVAL 500mg CR
tablet by Abbott Laboratories by performing quality
tests (Identification, Assay, Dissolution, Uniformity of
the dosage form).
CDP has been performed against the same brand that is
EPIVAL 500mg CR tablet by Abbott Laboratories 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 Method verification/validation studies have submitted
specificty.
Manufacturer of API M/s Sun Pharmaceutical Industries Ltd Address: Sathammai Village,
Karunkuzhi Post, Madhuranthagam Taluk, Kancheepuram District, Tamilnadu
– 603 303, India.
API Lot No. DVLNF20085
Description of Pack
Alu-Alu blister packed in unit carton (5×10’s)
Batch No. TDA001 TDA002 TDA003
Batch Size 2500 tablets 2500 tablets 2500 tablets
No. of Batches 03
1. Reference of previous approval of applications
The firm has not submitted any document.
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. K Dis, No:
manufacturer issued by concerned regulatory 17264/D1/4/2018 issued by Department of Safety &
authority of country of origin. Drugs Control Administration Government of
Tamilnadu valid untill 31/12/2021.
3. Documents for the procurement of API with Copy of letter No.10847/2020-DRAP
approval from DRAP (in case of import). Dated 06/08/2020 is submitted wherein the
permission to import different APIs including
Divalproex sodium USP for the purpose of
test/analysis and stability studies is granted.
Invoice Number: 700004927, dated 20/07/2020
Submitted
chromatograms,
5. Compliance Record of HPLC software 21CFR &
Submitted

1.6.5 Submit valid GMP Firm has submitted copy of Certificate#
certificate/DML of the drug 16478/D1/4/2021 issued by Department of Food
substance manufacturer. Safety & Drugs Control Administration,
Government of Tamil Nadu, valid upto 31-12-
2024.
2.3.R.1 Submit complete batch Firm has submitted batch manufacturing record for
manufacturing record for stability three stability batches.
batches.
3.2.P.1 Submit clarification regarding the Firm has referred to the molecular structure of
proposed quantity of Divalproex Dilavproex sodium which is comprised of sodium
sodium per unit tablet against the valproate and valproic acid in a 1:1 molar
label claim for Valproic acid. relationship, hence proposed weight per unit tablet
is justified with factor of molecular weight.
3.2.P.5.2 Specify which Dissolution test has Dissolution test 4 of USP monograph has been
been adopted from USP monograph adopted.
for the drug product specifications.
3.2.P.8.3 Submit raw data sheets for the Submitted.
dissolution test for complete
stability studies.
Decision: Approved with “Dissolution Test 4” of USP monograph of “Divalproex sodium extended release
tablet”.
Case no. 05 Registration applications for local manufacturing of (Human)

drugs
a. New cases
347. Name, address of Applicant / Marketing M/s Cortex Pharmaceuticals.
Authorization Holder Plot # 16-A, SS-4, RCCI, Rawat, Rawalpindi,
Punjab
Name, address of Manufacturing site. M/s Shawan Pharmaceuticals Plot No. 37, Road: Ns-
01, National Industrial Zone, Rawat, Rawalpindi
☐ Importer
(Contract manufacturing agreement between both
firms dated 25-08-2020 is provided)
GMP status of the firm Shawan Pharmaceuticals: Firm has submitted
copy of GMP certificate issued on the basis of
inspection dated 24-04-2019
Evidence of approval of manufacturing facility Firm has submitted copy of Issuance of renewal of
DML letter dated 03-09-2019 specifying Dry Vial
☐ Export sale
The proposed proprietary name / brand name Q-Dux 1000mg Injection
The status in reference regulatory authorities Sulperazone Intravenous Injection 1g (PMDA Japan
Approved)
For generic drugs (me-too status) Cefbac injection by Seraph Pharmaceuticals
Name and address of API manufacturer. Qilu Antibiotics Pharmaceutical Co Ltd. No. 849,
Dongia Town Licheng District Jinan City, Shandong
Province China.
its validation, batch analysis and justification of
drug product.
Module-III Drug Substance: Firm has submitted detailed data for drug substance
data related to nomenclature, structure, general
and controls, impurities, specifications, analytical
substance.
30°C ± 2°C / 65 ± 5% RH for 24 months.
Pharmaceutical Equivalence and Comparative Firm has submitted results of pharmaceutical
Dissolution Profile equivalence for their product against Zantum
Injection of Medizan.
Analytical method validation/verification of Firm has submitted report of verification studies of
product analytical method for the drug substance and
product.
Manufacturer of API Qilu Antibiotics Pharmaceutical Co Ltd. No. 849, Dongia Town Licheng
District Jinan City, Shandong Province China.
API Lot No. 1078DJ81NE
Description of Pack Glass Vials
Stability Storage Condition Real time : 30°C ± 2°C / 65% ± 5%RH
Frequency Accelerated: 0, 1, 2, 3, 6 (Months)
No. of Batches 03
348. Name, address of Applicant / Marketing M/s Cortex Pharmaceuticals.
Authorization Holder Plot # 16-A, SS-4, RCCI, Rawat, Rawalpindi,
Punjab
Name, address of Manufacturing site. M/s Shawan Pharmaceuticals.
Plot No. 37, Road: Ns-01, National Industrial Zone,
Rawat, Rawalpindi
☐ Importer
(Contract manufacturing agreement between both
firms dated 25-08-2020 is provided)
GMP status of the firm Shawan Pharmaceuticals: Firm has submitted
copy of GMP certificate issued on the basis of
inspection dated 24-04-2019
Evidence of approval of manufacturing facility Firm has submitted copy of Issuance of renewal of
DML letter dated 03-09-2019 specifying Dry Vial
☐ Export sale
The proposed proprietary name / brand name Q-Dux 2000mg Injection
Pharmaceutical ingredient (API) per unit Cefoperazone as Sodium…1g
Sulbactam as Sodium…1g
The status in reference regulatory authorities Approved in 03 European countries, i.e.,
Bulgaria: Sulcef 1g/1g powder for solution for
injection
Lithuania: Sulcef 1g/1g powder for solution for
injection
Slovakia: Sulcef 2g powder for solution for
injection
For generic drugs (me-too status) Cefbac injection by Seraph Pharmaceuticals
Name and address of API manufacturer. Qilu Antibiotics Pharmaceutical Co Ltd. No. 849,
Dongia Town Licheng District Jinan City, Shandong
Province China.
drug product.
substance.
30°C ± 2°C / 65 ± 5% RH for 24 months.
Dissolution Profile equivalence for their product against Zantum
Injection of Medizan.
Analytical method validation/verification of Firm has submitted report of verification studies of
product analytical method for the drug substance and
product.
Manufacturer of API Qilu Antibiotics Pharmaceutical Co Ltd. No. 849, Dongia Town Licheng
District Jinan City, Shandong Province China.
API Lot No. 1078DJ81NE
Description of Pack
Glass Vials
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Firm has submitted Copy of GMP certificate (No.
manufacturer issued by concerned regulatory SD20190876) issued by CFDA China is submitted
authority of country of origin. by the firm. The certificate is valid till 21-04-2024.
Firm has also submitted copy of DML of the firm
(No. Lu 20160006) issued by CFDA China. The
license is valid till 03-11-2025.
3. Documents for the procurement of API with  Firm has submitted copy of License issued by AD
approval from DRAP (in case of import). I&E specifying import of 200Kg Cefoperazone
sodium and Sulbactam sodium to M/s Shawan
Pharmaceuticals dated 22-06-2022
4. Data of stability batches will be supported by Firm has submitted complete record of testing of all
attested respective documents like batches along with chromatograms, raw data sheets,
chromatograms, Raw data sheets, COA, summary COA and summary data sheets.
data sheets etc.
Evaluation by PEC:

3.2.P.8.3 Submit both accelerated & long term stability Submitted
studies data till 6th month time point for all the
stability batches.
Decision: Registration Board approved the applications of “Q-Dux 1000mg Injection” & “Q-Dux 2000mg
Injection”.
 Firm shall submit Pharmaceutical equivalence studies of each strength against the innovator/brand
leader product before issuance of registration letter.
Registration Board further authorized its Chairman for issuance of registration letter upon consideration
of satisfactory capacity assessment of manufacturing and testing facility of M/s Shawan Pharmaceuticals
Plot No. 37, Road: Ns-01, National Industrial Zone, Rawat, Rawalpindi.
349. Name, address of Applicant / Marketing M/s CCL Pharma Pvt Ltd. Lahore
Name, address of Manufacturing site. M/s CCL Pharma Pvt. Ltd.
Plot 62 Quaid e Azam Industrial Estate Lahore.
☐ Importer
☐ Export sale
Details of fee submitted PKR 75,000/-: dated 16/03/2022
The proposed proprietary name / brand name Trijardy XR Tablet 25mg/5mg/ 1000mg
Pharmaceutical ingredient (API) per unit Empagliflozin………………..25mg
Linagliptin……………………5mg
Metformin HCl………………1000mg
Pharmaceutical form of applied drug Light Brown colored, oblong biconvex shaped film
coated tablet
Pharmacotherapeutic Group of (API) Blood glucose lowering drugs.
Reference to Finished product specifications Innovator
Proposed Pack size 5's, 10's, 14's, 20's, 28's, 30's, 50's and 100's
The status in reference regulatory authorities Trijardy XR Tablet 25mg/5mg/1000mg by M/s
Boehringer Ingelheim, USFDA Approved.
For generic drugs (me-too status) Not Applicable
GMP status of the Finished product GMP certificate granted on basis of inspection
manufacturer conducted on 30-04-2019
Name and address of API manufacturer. Empagliflozin: M/s Fuxin Long Rui Pharmaceutical
Co., Ltd China.
Fluoride industrial Park, Fumeng County (Yi Ma Tu),
Fuxin City, Liaoning Province - 123000, China
Linagliptin: M/s Fuxin Long Rui Pharmaceutical
Co., Ltd China.
Metformin HCl: Wanbury Limited.
Doctors Organic Chemical Division K Illindalaparru-
534217, Iragavaram Mandal,
West Godavari District Andhra Pradesh; India.
Module III (Drug Substance) The firm as submitted detail of nomenclature,
substance
Accelerated: 40°C ± 2°C / 75% ± 5%RH for 6
months
Empagliflozin Batches: (20160606, 20161017,
20161219)
Linagliptin Batches: (L-20170429-D01-L9-01, L-
20170604-D01-L9-02, L-20170604-D01-L9-03)
Metformin HCL Batches: (MS-0220601 Lot A, MS-
0220601 Lot B, MS-0230601 Lot A, MS-0230601 Lot
B, MS-0240601 Lot A, MS-0240601 Lot B,
specifications, analytical procedure and its validation
studies, batch analysis and justification of
dissolution profile against the innovator Trijardy XR 25mg / 5mg/
1000mg Tablet manufactured by M/s Boehringer
Ingelheim international by performing quality tests
(Identification, Assay, Dissolution, Uniformity of
dosage form).
CDP has been performed against the same brand that
is Trijardy XR 25mg / 5mg/ 1000mg Tablet
manufactured by M/s Boehringer Ingelheim in Acid
media & Phosphate Buffer. The values for f1 and f2
are in the acceptable range.
Analytical method validation/verification of Method validation studies have submitted including
Manufacturer of API Empagliflozin: M/s Fuxin Long Rui Pharmaceutical Co., Ltd China.
Fluoride industrial Park, Fumeng County (Yi Ma Tu), Fuxin City, Liaoning
Province - 123000, China
Linagliptin: M/s Fuxin Long Rui Pharmaceutical Co., Ltd China.
Doctors Organic Chemical Division K Illindalaparru- 534217, Iragavaram
Mandal, West Godavari District Andhra Pradesh; India.
API Lot No. Empagliflozin: H-E-20201125-D03-E06-02
Linagliptin: L-20200920-D01-L09-01
Metformin HCl: MT02000221
Description of Pack
Batch No. ELMXD-T2-21 ELMXD-T3-21 ELMXD-T4-21
Batch Size 1000 tab 1000 tab 1000 tab
No. of Batches 03
350. Name, address of Applicant / Marketing M/s CCL Pharma Pvt Ltd. Lahore
Name, address of Manufacturing site. M/s CCL Pharma Pvt. Ltd.
Plot 62 Quaid e Azam Industrial Estate Lahore.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Trijardy XR Tablet 12.5mg/2.5mg/ 1000mg
Pharmaceutical ingredient (API) per unit Empagliflozin………………..12.5mg
Linagliptin……………………2.5mg
Pharmaceutical form of applied drug Brown colored, oblong biconvex shaped film coated
tablet
The status in reference regulatory authorities Trijardy XR Tablet 12.5mg/2.5mg/1000mg by M/s
Co., Ltd China.
Co., Ltd China.
substance
months
20161219)
20170604-D01-L9-02, L-20170604-D01-L9-03)
B, MS-0240601 Lot A, MS-0240601 Lot B,
dissolution profile against the innovator Trijardy XR 12.5mg / 2.5mg/
dosage form).
is Trijardy XR 12.5mg / 2.5mg/ 1000mg Tablet
Description of Pack
Batch No. ELMXC-T2-21 ELMXC-T3-21 ELMXC-T4-21
No. of Batches 03
351. Name, address of Applicant / Marketing M/s CCL Pharma Pvt. Ltd.Plot 62 Quaid e Azam
Authorization Holder Industrial Estate Lahore.
Name, address of Manufacturing site. M/s CCL Pharma Pvt. Ltd.Plot 62 Quaid e Azam
Industrial Estate Lahore.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Trijardy XR Tablet 10mg/5mg/ 1000mg
Linagliptin……………………5mg
Pharmaceutical form of applied drug Light Green colored, oblong biconvex shaped film
coated tablet
The status in reference regulatory authorities Trijardy XR Tablet 10mg/5mg/1000mg by M/s
Co., Ltd China.
Co., Ltd China.
substance
months
20161219)
20170604-D01-L9-02, L-20170604-D01-L9-03)
B, MS-0240601 Lot A, MS-0240601 Lot B,
dissolution profile against the innovator Trijardy XR 10mg / 5mg/
dosage form).
is Trijardy XR 10mg / 5mg/ 1000mg Tablet
Description of Pack
Batch No. ELMXB-T2-21 ELMXB-T3-21 ELMXB-T4-21
No. of Batches 03
352. Name, address of Applicant / Marketing M/s CCL Pharma Pvt. Ltd. Plot 62 Quaid e Azam
Authorization Holder Industrial Estate Lahore.
Name, address of Manufacturing site. M/s CCL Pharma Pvt. Ltd. Plot 62 Quaid e Azam
Industrial Estate Lahore.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Trijardy XR Tablet 5mg/2.5mg/ 1000mg
Linagliptin……………………2.5mg
Pharmaceutical form of applied drug Green colored, oblong biconvex shaped film coated
tablet
The status in reference regulatory authorities Trijardy XR Tablet 5mg/2.5mg/1000mg by M/s
GMP status of the Finished product GMP inspection conducted on 21-02-2023 concludes
manufacturer satisfactory level of compliance.
Co., Ltd China.
Co., Ltd China.
substance
months
20161219)
20170604-D01-L9-02, L-20170604-D01-L9-03)
Metformin HCl Batches: (MS-0220601 Lot A, MS-
B, MS-0240601 Lot A, MS-0240601 Lot B,
dissolution profile against the innovator Trijardy XR 5mg / 2.5mg/
dosage form).
is Trijardy XR 5mg / 2.5mg/ 1000mg Tablet
Description of Pack
Batch No. ELMXA-T2-21 ELMXA-T3-21 ELMXA-T4-21
No. of Batches 03
1. Reference of previous approval of applications The firm has submitted the list of products previously
with stability study data of the firm (if any) approved with stability study data.
2. Approval of API/ DML/GMP certificate of API Empagliflozin: Copy of GMP certificate valid till
manufacturer issued by concerned regulatory 23/08/2023 issued by Lioning Fuxin management
authority of country of origin. committee.
Linagliptin: Copy of GMP certificate valid till
23/08/2023 issued by Lioning Fuxin management
committee.
Metformin HCl: Copy of License retention certificate
valid till 28-07-2023 issued by Drug Control
Administration, Andhra Pradesh, India
3. Documents for the procurement of API with  Empagliflozin: Commercial invoice no.
approval from DRAP (in case of import). HN21010701-J attested by AD I&E DRAP, Lahore
dated 23/02/2021.
 Linagliptin: Invoice No. HN201215-L attested by
AD I&E DRAP, Lahore dated 15-Dec-2020
 Metformin HCl: Commercial Invoice No.
92003827 attested by AD DRAP I&E Lahore dated
05/02/2021.
chromatograms,
5. Compliance Record of HPLC software 21CFR Submitted
6. Record of Digital data logger for temperature Submitted
and humidity monitoring of stability chambers
Section# Observations Firm’s response Remarks

1.5.2 Submitted label claim shall Elaborated label claim is as
elaborate the immediate release follow:
and extended release layer of the Each film coated tablet
applied formulation. contains;
Empagliflozin &
Linagliptin as Immediate
Release
Metformin HCl as
Extended-Release
Firm has submitted fee of
Rs.75,000/- for revision of
label claim for each
strength
1.6.5 Copy of Valid GMP Copy of Manufacturing
certificate./DML for M/s Fuxin License (License # LIAO
Long Rui, issued by relevant 20150233) issued by
regulatory authority shall be Liaoning Medical Products
submitted. Administration, valid upto
17-01-2027 for M/s Fuxin
Long Rui has been
submitted
Empagliflozin
3.2.S.1.3 In contrary to the innovator drug The phrase "practically Declaration from
product literature from the US FDA insoluble" was a the drug substance
& EMA, the section declares the typographical error. In manufacturer
solubility in water as “practically section S.1.3, regarding shall be submitted
insoluble”. Justification shall be quantitative aqueous regarding the
submitted in this regard. solubility, we have stated solubility of
that the solubility of Empagliflozin.
Empagliflozin in water is The submitted
0.5 mg/ml. annexure still
mentions the
statement of
practically
insoluble in water.
Metformin HCl
3.2.S.4.4 Submitted COA of Metformin HCl We adhere to the The Assay and
from M/s Wanbury declare that the specifications mentioned in related substances
product complies with BP- the British Pharmacopoeia limits of USP &
2014/USP-35. Clarification shall be (BP). The specifications for BP monograph
submitted in this regard. the drug substance are are different.
attached as 3.2. S.4.1. The
USP and BP monograph is not API manufacturer has
harmonized hence justification shall stated their compliance
be submitted from the drug with both compendia.
substance manufacturer for We would like to state that
claiming both standards Wanbury Limited is EDQM
simultaneously. certified manufacturer
bearing certificate number.
R1-CEP 1998-079 - Rev
10.
Further we have also
submitted justification of
specification attached by
the drug substance
manufacturer
Drug substance
specifications are submitted
Further Manufacturer is
complying to USP 35 and
BP 2014, and both the
monograph are
harmonized.
Furthermore, we are
complying to BP 2022
specifications.
Linagliptin
3.2.S.1.3  Submitted DMF declare the As per CDER, Linagliptin Innovator
Polymorphic form as A, exist in two polymorphic literature review
whereas Innovator drug product forms- Form A and Form B. declares the
literature declares that these two forms are Linagliptin as a
Linagliptin is manufactured as a enantiotropically related mixture of
mixture of anhydrous form A and reversible interconvert anhydrous form A
and anhydrous form B. at approximately room and anhydrous
Justification shall be submitted temperature. Both forms form B while
in this regard. are stable and highly justification is
 Clarification shall be submitted soluble and both forms are required from
regarding the isomeric form of equivalent with respect to drug substance
the drug substance. equilibrium solubility and manufacturer for
intrinsic dissolution rate, declaring the drug
which indicates that substance as
polymorphism does not single
affect manufacturability or polymorphic
bioavailability. form.
3.2.S.4  Justification shall be submitted Test for Enantiomeric Innovator
for not including test of Purity can ensure that the literature has
“Enantiomeric purity” in the content of S-enantiomer in recommended test
drug substance specifications. the product which should be of enantiomeric
less than 0.15%. purity as stability
Further, it is evident from test and
literature that identification test
interconversion of by Chiral HPLC.
Linagliptin to S-Linagliptin Firm has not
does not show meaningful submitted any
amounts of S-enantiomer in literature
the drug substance. reference to
Hence, there is no need to establish the fact
perform Identification by that performance
chiral HPLC. of test for S-
Furthermore, both the API enantiomer
manufacturer and FPP (Enantiomeric
manufacturer have already purity test) is not
performed Identification necessary.
using two different Furthermore
methods, namely HPLC Registration
and IR, in accordance with Board in its 324th
the recommendations meeting has
outlined in ICH Q6A. recommended
However, we have performance of
requested our Drug test Enantiomeric
substance manufacturer to purity for
add the test for Linagliptin.
Enantiomeric impurity in
their Specifications. We
have also revised our Drug
substance specifications
including Test for
Enantiomeric Impurity
3.2.S.4.4  Submitted COA of drug Test for Enantiomeric
substance from both drug Purity can ensure that the
product and drug substance content of S-enantiomer in
manufacturer does not confirm the product which should be
“Enantiomeric purity”. less than 0.15%.
Justification shall be submitted Further, it is evident from
in this regard. literature that
interconversion of
Linagliptin to S-Linagliptin
does not show meaningful
amounts of S-enantiomer in
the drug substance. Hence,
there is no need to perform
Identification by chiral
HPLC.
3.2.S.5 Submitted COA of working Valid Working standard COA of
standard of Linagliptin does not COA of Linagliptin was reference/working
declare the validity date. already attached in 3.2. P.6. standard used for
Same has been submitted. the drug substance
analysis of
Linagliptin by
M/s CCL shall be
submitted.
3.2.P.1  Justification shall be submitted As per innovator patent Firm has
for the seal coating applied on document submitted
Metformin HCl core, while “PCT/EP2016/079465” the document for seal
referring to the innovator drug Metformin XR core is coating
product formulation. barrier coated using one or justification
 Details of the equipment shall more barrier coating agents which is extract of
be submitted wherein Drug- such as mixture of a patent instead of
Excipient compatibility study hydroxypropyl cellulose, submitting the
has been conducted with HPMC or mixture of PVA, reference from
following stress conditions: PEG. innovator drug
 Temperature: 60oC we have utilized HPMC, product literature
 Humidity: 75%RH Talc, Purified water, and approved by
titanium dioxide for the seal reference
coat, following the regulatory
innovator's specifications. authorities.
Reference is attached as
Annex-4.
We have dedicated,
stability chamber for such
use.
Make: Memmert
(X511.0138)
Eqp ID: QC 018
Record of data logger is
attached as Annex-5
3.2.P.2  Justification shall be submitted  As per FDA Inactive
for proposed quantity of Ingredient Search for
Arginine in the formulation. Approved Drug
 Submit the Products, the permitted
image/picture/snapshot of the quantity for Arginine is
innovator/reference/comparator up to 50mg, while our
pack against which product has quantity up
Pharmaceutical equivalence / to 10mg which is
Comparative Dissolution within the permitted
Profile studies have been limits.
performed and shall reveal the
details of brand name,  Images of innovator
manufacturer, batch# and packs used for
expiry date of the pharmaceutical
innovator/reference/comparator equivalence studies are
product. submitted.
 Justification shall be submitted
for not performing tests of  We hereby commit that
water content, uniformity of Arginine content;
content, microbial purity and Water content &
arginine content in content uniformity test
Pharmaceutical equivalence will be part of our next
studies as recommended by the Stability Study Testing
innovator product literature Interval as well as said
review from reference test will be part of our
regulatory authorities. QC Release
Specifications before
commercialization.
 We have already
performed the
uniformity of content
for our product.
 We have tested for
Average weight,
content uniformity and
dissolution during the
study.
Further, Arginine is
considered as an
excipient that is why he
have not tested it
during pharmaceutical
equivalence studies.
However now we have
added it in our
specifications
3.2.P.3.4 In contrary to the recommendations We have been procuring
of innovator product literature, Empagliflozin and
“particle size” of Empagliflozin & Linagliptin from our
Linagliptin has not been identified prequalified source.
as Critical Quality Attribute. We have already performed
Comparative dissolution
profile and dissolution of
our various sku’s and all
product complies to the
specification for claimed
shelf life.
However, we have also
requested our Drug
substance manufacturer to
perform the said test on
next batches for
compliance.
3.2.P.3.5 Submitted process validation Revised Process Validation
protocol does not include details of Protocol has been
in-process test applied to confirm submitted.
that desired content for
Empagliflozin and Linagliptin has
been achieved via active coating.
3.2.P.5.1  Justification shall be submitted We hereby commit that Firm has not
for not including tests of water Arginine content; Water submitted revised
content, microbial purity and content & content analytical
arginine content in drug product uniformity test will be part procedure
specifications as recommended of our next Stability Study including test for
by the innovator product Testing Interval as well as Arginine & water
literature review from reference said test will be part of our content.
regulatory authorities. QC Release Specifications
3.2.P.5.4  Justification shall be submitted before commercialization.
for not performing tests of
water content, microbial purity
and arginine content in batch
analysis as recommended by
innovator drug product
literature
3.2.P.6 COA of primary / secondary COA of working standard
reference standard including source is submitted.
and lot number shall be provided.
3.2.P.8.3  Justification shall be submitted We hereby commit that
for not including tests of water Arginine content; Water
content, microbial purity and content & content
arginine content in stability uniformity test will be part
studies. of our next Stability Study
 Compliance Record of HPLC Testing Interval as well as
software 21CFR & audit trail said test will be part of our
reports on product testing shall QC Release Specifications
be submitted. before commercialization.
2.3.R  Submitted BMR declare  The justification for Submitted process
dispensing of Empagliflozin & achieving 100% validation
Linagliptin as per 100% content content when both protocol declares
of desired label claim. APIs are included use of
Justification shall be submitted through Active coating Conventional
that how dispensed quantity is as follows: coating pan.
will produce 100% content of
Empagliflozin & Linagliptin,  Through careful
when both APIs are being formulation and
included by way of Active testing, the coating
coating and how the wastage of solution is designed to
coating solution will be provide adequate
compensated. coverage and retention
 Justification shall be submitted of both Empagliflozin
for the seal coating applied on and Linagliptin during
Metformin HCl core, while the coating process.
referring to the innovator drug  Further, the coating
product formulation. process is conducted in
 Justification shall be submitted Automatic coating
for proceeding for the seal final machine.
film coating step without
establishing the content of  As per innovator patent
Empagliflozin & Linagliptin at document
in process stage of active “PCT/EP2016/079465”
coating. the metformin XR core
 Clarification shall be submitted is barrier coated using
for the test applied to confirm one or more barrier
that desired content for coating agents such as
Empagliflozin and Linagliptin mixture of
has been achieved via active hydroxypropyl
coating since submitted trial cellulose, HPMC or
batch manufacturing record mixture of PVA, PEG.
does not include any in process we have utilized
testing. HPMC, Talc, Purified
 Minimum handling capacity of water, and titanium
the equipment used in the dioxide for the seal
manufacturing of trial batches coat, following the
shall be submitted. innovator's
specifications.
 The coating solution
undergoes testing
before the coating
process takes place.
However, the
Certificate of Analysis
(COA) for the coating
solutions is not
included in the Trial
Batch Manufacturing
Record (BMR).
 Our R&D Laboratory is
equipped with
Automatic coating
machine with minimum
handling capacity of
500gm and maximum
capacity of 3.0Kg.
Model: BGC 400
Decision: Registration Board deferred the applications of Trijardy XR Tablet 25mg/5mg/ 1000mg,
Trijardy XR Tablet 12.5mg/2.5mg/ 1000mg, Trijardy XR Tablet 10mg/5mg/ 1000mg & Trijardy XR
Tablet 5mg/2.5mg/ 1000mg for following:
 Declaration from the drug substance manufacturer shall be submitted regarding the solubility of
Empagliflozin.
 Evidence based justification for the claim of firm that USP & BP monograph of Metformin HCl is
harmonized.
 Justification for from the drug substance manufacturer for claiming both standards i.e., USP & BP
simultaneously for Metformin HCl.
 Scientific justification, with reference to innovator drug product literature, for claiming Linagliptin
as “Polymorphic form A” insetad of “mixture of anhydrous form A and anhydrous form B”.
 Clarification shall be submitted regarding the isomeric form of the drug substance.
 Scientific Justification shall be submitted for not including test of “Enantiomeric purity” in the drug
substance specifications as recommended by the innovator drug product literature.
 Submitted COA of drug substance from both drug product and drug substance manufacturer does
not confirm “Enantiomeric purity” and identification test of Chiral purity. Justification shall be
submitted in this regard with reference to innovator drug product literature.
 COA of reference/working standard used for the drug substance analysis of Linagliptin by M/s CCL
shall be submitted.
 Scientific justification shall be submitted for the role and impact of seal coating applied on
Metformin HCl core, while referring to the innovator drug product formulation.
 Performance of Pharmaceutical equivalence studies against the innovator drug product including
tests of water content, uniformity of content, microbial purity and arginine content.
 Scientific justification shall be submitted for not including tests of water content and arginine
content in stability studies with reference to the innovator drug product literature.
 Justification shall be submitted for proceeding for the final film coating step without establishing
the content of Empagliflozin & Linagliptin at in process stage of active coating.
 Evidence based justification regarding the claim of achieving 100% content as per label claim of
Empagliflozin & Linagliptin, withput consuming excessive active coating solution.
b. Deferred cases
353. Name, address of Applicant / Marketing M/s Ahad International Pharmaceuticals Ltd
Authorization Holder Dera Ismail Khan
Name, address of Manufacturing site. M/s Ahad International Pharmaceuticals Ltd, 13 KM
Gomal University Multan Road Dera Ismail Khan
☐ Importer
☐ Export sale
Details of fee submitted PKR 30,000/-: vide deposit slip# 4953647152
The proposed proprietary name / brand name Parasafe Infusion 1gm/100ml
Strength / concentration of drug of Active Each 100ml infusion contains:
Pharmaceutical ingredient (API) per unit Paracetamol ……. 1gm
Pharmaceutical form of applied drug Solution for infusion
Pharmacotherapeutic Group of (API) Analgesic and Antipyretic
Reference to Finished product specifications In house specification
The status in reference regulatory authorities Paracetamol 10mg/ml solution for infusion (One
100ml vial contains 1000mg Acetaminophen) of M/s
Accord-UK Ltd approved by MHRA of UK
For generic drugs (me-too status) Provas Infusion 1Gm/100ml by Sami Pharma
GMP status of the Finished product Panel inspection report dated 09-07-2020 concludes
manufacturer satisfactory level of cGMP compliance.
Evidence of manufacturing facility Copy of panel inspection report dated 09-07-2020 has
been submitted wherein availability of “Sterile Vial
Infusion” & “Ampoule” section has been mentioned.
Name and address of API manufacturer. M/s Citi Pharma (Pvt) Ltd, 3KM Head Baloki Road
Phool Nagar District Qasur
Module-II (Quality3. Overall Summary) Firm has submitted QOS as per WHO QOS-PD
Module III (Drug Substance) Official monograph of Acetaminophen is present in
USP and BP. The firm as submitted detail of
impurities, specifications, analytical procedure and
its verification studies, batch analysis and
product.
Pharmaceutical equivalence Pharmaceutical Equivalence have been established
against the Provas infusion 1Gm/100ml by Sami
Pharma.
product linearity, range, accuracy, precision, specificty.
Manufacturer of API M/s Citi Pharma (Pvt) Ltd, 3KM Head Baloki Road Phool Nagar District Qasur
API Lot No. PGP20-423, PARA/AWAS-001/20-001
Description of Pack
Glass vial
Frequency Accelerated: 0, 3,6 (Months)
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. 001 002 003
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Not Submitted
3. Documents for the procurement of API with Not Submitted
4. Data of stability batches will be supported by Not Submitted
chromatograms, Raw data sheets, COA,
summary data sheets etc..
5. Compliance Record of HPLC software 21CFR N/A
6. Record of Digital data logger for temperature Not submitted

3.2.S.3.1 The said section declares M/s According to invoice Neon chemical is our
Hebei Jiheng Pharmaceutical Co. indenter which deals both companies. Now we are
Ltd as producer of performing all the procedure according to Hebei
Acetaminophen instead of M/s Jiheng Pharma.
Citi Pharma.
3.2.S.4.2 Analytical procedure submitted Drug substance manufacturer complies both BP &
by Drug substance manufacturer USP specifications. Now we adopt analytical
is as per USP monograph, procedure according to USP specification.
whereas Drug product
manufacturer has submitted
analytical procedure as per BP
monograph. Justification shall be
submitted for this variation.
3.2.S.4.3  Clarification shall be  Analytical method verification studies have
submitted that whether been performed M/s Ahad International.
submitted analytical method  Performed according ot USP monograph.
verification studies have
been performed by M/s Citi
Pharma or M/s Ahad
International.
 Clarification shall be
submitted that whether
submitted analytical method
verification studies have
been performed as per USP
or BP monograph.
3.2.S.4.4  COA of Paracetamol  Firim has submitted COA of drug substance
submitted from M/s CITI from M/s Hebei Jiheng Pharmaceutical Co.
Pharma declares it as Ltd. China for batch# COS012012049 which
“Analytical Working also includes sterility test.
Standard”, whereas 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
manufacturer shall be
submitted.
 Submitted COA form M/s
Citi Pharma & M/s Ahad
International does not
include test of sterility.
Clarification shall be
submitted in this regard,
since the drug substance is to
be used in the formulation of
a sterile product.
3.2.S.4.5 The said section declares that the Drug substance manufacturer complies both BP &
specifications adopted are as per USP specifications. Now we adopt analytical
the monograph specified in USP procedure according to USP specification.
while in section 3.2.S.4.2
analytical procedure as per BP
monograph has been submitted.
3.2.P.3.5 Submitted process validation It is typographic mistake while the original
protocol mentions the strength as strength is 1000mg/100ml.
1000mg/10ml whereas applied
strength is 1000mg/100ml.
3.2.P.5.1 Justification shall be submitted Actual pH range 5 – 7 for drug product according
for the proposed pH range of 4.0 to USP specifications.
-7.0 for the drug product since
the available literature of the
reference product declares
different pH range than that
proposed by the applicant.
3.2.P.5.3 Performance of Linearity Submitted.
parameter shall be submitted in
Analytical method validation
studies.
3.2.P.5.4 The copies of complete analysis Firm has submitted copies of batch analysis reports
reports of all three trial batches fo all three stability bayches including results for
shall be provided. sterility testing and endotoxin.
Submitted analytical report of
Trial-01 does not include test of
Sterility & Endotoxin.
3.2.P.8  Submitted invoice from M/s  Firm has submitted copy of letter from M/s
Neon Chemicals declare Neon Chemicals, declaring submission of drug
quantity of Paracetamol as of sample of 2Kg from M/s Hebei Jiheng
50gm. Justification shall be Pharmaceutical Co., Ltd., China to M/s Ahad
submitted for manufacturing International.
of three trial batches of  No document attested by AD I&E DRAP has
400vials each with 50gm of been submitted in this regard.
API.  Firm has submitted revised stability summary
 Submitted stability summary sheets m conditions as per Zone Iva.
sheets & reports declare  Firm has submitted revised analytical record
condition of real time along with chromatograms.
stability studies as 25°C ±  Record of digital data logger has been
2°C / 60% ± 5%RH which is submitted.
not as per Zone IVa.  GMP certificate eof the drug substance
 Submitted analytical record manufacturer has not been submitted.
shows that Assay
calculations for all three
stability batches at each time
point of both accelerated &
long-term stability studies
have been performed by
applying same value of
Standard peak area.
Justification shall be
submitted in this regard.
 Record of data logger of
stability chambers shall be
submitted.
 Approval of API/
DML/GMP certificate of
API manufacturer issued by
concerned regulatory
authority of country of origin
shall be submitted.
rd
Decision of 323 meeting: Deferred for clarification regarding manufacturer of drug substance along with
documents confirming procurement of drug substance with approval of DRAP I&E office.
Firm’s response: Firm has submitted documents for the procurement of Paracetamol from M/s Citi Pharma (Pvt.)
Ltd., 3.5-km, head Baloki Road, Phool Nagar, Kasur-Pakistan including commercial invoice, COA of drug
substance and copy of GMP certificate issued on basis of inspection conducted on 17-12-2020.
Decision: Regsitration Board decided to defer the application for personal hearing of firm regarding the
varied information submitted regarding the source of drug substance.
354. Name, address of Applicant / Marketing M/s Martin Dow Marker Limited, 7-Jail Road, Quetta
Name, address of Manufacturing site. M/s Martin Dow Marker Limited,
F-126, S. I. T. E., Karachi, Pakistan
Status of the applicant ☐Manufacturer
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy.No 25930 dated 17/09/2021
PKR 25,000/-: dated 30/06/2021
The proposed proprietary name / brand name ADVITA 20,000 IU CAPSULES
Strength / concentration of drug of Active Each Soft gel Capsule contains:
Pharmaceutical ingredient (API) per unit Cholecalciferol…...20,000 IU
Pharmaceutical form of applied drug Clear light-yellow oily liquid
Pharmacotherapeutic Group of (API) Vitamin D analogs
The status in reference regulatory authorities Fultium 20,0000 IU Capsule by M/s Internis
Pharmaceuticals Limited, MHRA Approved.
For generic drugs (me-too status)
GMP status of the Finished product Certificate No: F.14-1/DRAP/GMP/MDM-2022
manufacturer issued on 03rd Feb 2022
Soft Gelatin Capsule (General) Dispensing, Mixing,
Drying, Granulation, Compression, Coating,
Blistering & Packaging.
Name and address of API manufacturer. M/s DSM Nutritional Product, France
system and stability studies of drug substance and drug
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: 25°C ± 2°C / 60% RH ± 5% RH for 24
months
Accelerated: 30°C ± 2°C / 65% RH ± 5% RH for 6
months
impurities, specifications, analytical procedure,
dissolution profile against the brand leader that Fultium 20,0000 IU
Capsule by M/s Internis Pharmaceuticals Limited.
Since Vitamin D3 capsules are Fat soluble in nature so
the dissolution in not recommended by any
Pharmacopoeia & FDA dissolution guideline.
Manufacturer of API M/s DSM Nutritional Product, France
API Lot No. 11F01901004
Description of Pack
Aluminum foil with PVC/PVDC blister (2×7’s)
Batch No. TR-007/20 TR-008/20 TR-009/20
Batch Size 10000 capsule 10000 10000 capsule
capsule
No. of Batches 03
Reference of previous approval of applications Acidex 60mg Capsule
with stability study data of the firm (if any) Dexlansoprazole was approved in 312th Registration
Board meeting.
Compliance Record of HPLC software 21CFR & audit
trail reports on product testing were present
Approval of API/ DML/GMP certificate of GMP Certificate No 18MPP077HFR02 issued by
API manufacturer issued by concerned EUDRA . Period of validity is extended to 26.09.2023
regulatory authority of country of origin. in case of cholecalciferol .
Documents for the procurement of API with M/s DSM Nutritional Product, France ADC Invoice
approval from DRAP (in case of import). No: 2831239200, 29-08-2019
Data of stability batches will be supported by Firm has submitted record of testing of batches along
attested respective documents like with
chromatograms, chromatograms, raw data sheets, COA and summary
Raw data sheets, COA, summary data sheets data sheets
etc.
Compliance Record of HPLC software 21CFR The firm has submitted compliance record of HPLC
& audit trail reports on product testing software 21
CFR and copies of audit trail on testing of drug product.
Record of Digital data logger for temperature Firm has submitted record of data logger for
and humidity monitoring of stability chambers temperature and humidity monitoring of real time and
(real time and accelerated) accelerated stability chambers.
Remarks OF Evaluator:
Decision of 320th meeting: Deferred for following points:
Clarification of conditions of stability studies of drug substance and drug product.
Justification why comparative dissolution profile studies are not performed against the innovator drug product.
Firm’s response:
Cholecalciferol is sensitive & not stable when exposed to high temperature condtion so in the light of above
condition stability performed at 25oC +2oC/60% RH +5%RH. SmPc of innovator product “Fultium-D3 20,000IU
capsules” clearly instructed to store the product below 25oC.
As Choleclaciferol is present in USP and its nature is fat soluble. Therefore, its dissolution is not recommended in
any Pharmacopoeia as well as FDA dissolution guideline. While complete comparative analysis & Pharmaceutical
equivalence with innovator has already been submitted with initial dossier.
Decision of 323rd meeting: Deferred for following:
Scientific justification for performing drug product stability studies on storage conditons different from that
required by ICH/WHO guidelines for Zone IVA.
Submission of reference from pharmacopoeia/ innovator drug product literature regarding non-performance of
dissolution test for applied formulation.
Firm’s response:
S. Observation Reply
No
1. Scientific justification for Cholecalciferol (Vitamin D3) is a sensitive vitamin &
performing drug product not stable when exposed to high temperature
stability studies on storage conditions so in the light of above condition stability
conditions different from that performed at 25°C ± 2°C / 60% RH ± 5% RH.
required by ICH/WHO Leaflet (enclosed) of innovator product “Fultium
guidelines for Zone IVA. 20,000 IU Capsule” clearly instructed to store the
product below 25°C.
2. Submission of reference from Cholecalciferol (Vitamin D3) is present in USP
pharmacopoeia/ innovator drug pharmacopeia & its nature is fat soluble. Therefore, its
product literature regarding dissolution is not recommended in any pharmacopeia
nonperformance of dissolution as well as FDA dissolution guideline. USP
test for applied formulation. Monograph of Cholecalciferol Capsule attached for
reference.
While complete comparative analysis and
pharmaceutical equivalence with innovator has been
done and already submitted with initial dossier.
Decision of 324th meeting: Deferred for submission of following:
 Justification of not performing stability studies as per Zone-IV A conditions since the MHRA Public
Assessment Report of the innovator product i.e., Fultium –D3 20,000 IU capsule recommends storage
condition as “Do no store above 300C”.
 Justification on the basis of analytical record and stability studies that at what time point the product is
unstable when stored at Zone IVA conditions for stability studies.
Firm’s response:
 We performed long term stability studies at (25°C /60%RH) & accelerated at (40°C /75%RH) but due to
appearance and degradation non-compliance at 6-month accelerated stability was observed. After that, we
went for intermediate stability studies (30°C /65%RH) as per above mentioned guidelines to justify the
stability of our product.
 Firm has now submitted real time stability studies data of three batches at 30°C /65%RH conditions for
24 months.
Decision: Approved.
355. Name, address of Applicant / M/s BJ Pharmaceuticals, 18km mandiali stop, sheikupura
Marketing Authorization Holder road lahore
Name, address of Manufacturing site. M/s BJ Pharmaceuticals, 18km mandiali stop, Sheikhupura road
lahore
☐ Importer
Intended use of pharmaceutical ☒ Domestic sale
product ☐ Export sale
Dy. No. and date of submission Dy. No. 347: 04-03-2021
Details of fee submitted PKR 20,000/-: 17-02-2021
The proposed proprietary name / Trexime 200mg capsule
brand name
Strength / concentration of drug of Each capsule contains:
Active Pharmaceutical ingredient Cefixime as trihydrate…200mg
(API) per unit
Reference to Finished product JP
specifications
The status in reference regulatory SUPRAX 200 mg CAPSULE by SANOFI Aventis
authorities Spain Approved
For generic drugs (me-too status) Cefiget 200 mg Capsule by M/s GETZ Pharma
GMP status of the Finished product 15-1-2020, Overall hygienic condition of the firm is satisfactory at
manufacturer the time of inspection. Firm has cephalosporin capsule section.
Name and address of API M/s. Pharmagen Ltd Kot nabi Kuksh wala, 34km ferozpur road
manufacturer. Lahore.
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO QOS-PD template. Firm has
summarized information related to nomenclature, structure,
general
Characterization, specifications, analytical procedures and its
validation, batch analysis and justification of specification,
reference standard, container closure system and stability studies
of
drug 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/verification of analytical procedures, batch analysis,
justification of specifications, reference standard or materials,
Module-III (Drug Product): Firm has submitted relevant information against the Module III,
including, Comparative dissolution studies (reference product is
cefspan capsule) Process validation protocol, Finished product
analytical method validation report & stability studies data.
Manufacturer of API M/s. Pharmagen Ltd Kot nabi Kuksh wala, 34km ferozpur road Lahore.
API Lot No. 00244-043-2020
Description of Pack
Blister
Frequency Accelerated: 0,3, 6 (Months)
Real Time: 0, 3, 6, (Months)
Batch No. XT1 XT2 XT3
Batch Size 5000cap 5000cap 5000cap
No. of Batches 03
1. Reference of previous approval of  N/A
applications with stability study data of
the firm (if any)
2. Approval of API/ DML/GMP certificate GMP certificate was issued to M/s Pharmagen Ltd based on
of API manufacturer issued by evaluation conducted on 8-1-2019.
concerned regulatory authority of
country of origin.
3. Documents for the procurement of API Invoice from Pharmagen Ltd specifying purchase of cephradine
with approval from DRAP (in case of 25Kg is provided.
import).
4. Data of stability batches will be Firm has submitted record of testing of all batches along with
supported by attested respective chromatograms, raw data sheets, COA and summary data sheets.
documents like chromatograms, Raw The firm has2 Galvano Scientific stability chambers, Model STC-
data sheets, COA, summary data sheets SS-400-LAC with 400liter capacity
etc.
5. Compliance Record of HPLC software N/A
21CFR & audit trail reports on product
testing
6. Record of Digital data logger for Firm has submitted record of data logger for temperature and
temperature and humidity monitoring of humidity monitoring of real time and accelerated stability
stability chambers (real chambers
time and accelerated) (VI)
Observation communicated Response

Comparative dissolution profile (CDP) studies should be The firm has submitted comparative
conducted in three BCS media (pH 1.2, 4.5 and 6.8) across dissolution profile (CDP) in three BCS
the physiological pH range along with calculation of media and calculated similarity factor
similarity factor f2 should be submitted and discussed as f2 using CDP results.
per requirements of section 3.2.P.2.
Provide copy of Batch Manufacturing Record (BMR) of The firm has provided copies of
the batch XT1 of drug product for which stability studies respective batch manufacturing record
data is provided in Module 3 section 3.2.P.8.3 of the prepared batch.
Submit description of the primary container closure Description for the container closure
systems, including materials of construction as per section system has been submitted.
3.2.P.7.
2.3.R Regional Information is not submitted. Regional information has been
submitted.
Decision of 308th meeting: Registration Board deferred the case for further deliberation regarding finished
product specifications of applied formulation/strength.
356. Name, address of Applicant / M/s BJ Pharmaceuticals, 18km mandiali stop, sheikupura road
Marketing Authorization Holder lahore
Name, address of Manufacturing site. M/s BJ Pharmaceuticals, 18km mandiali stop, sheikupura road
lahore
☐ Importer
The proposed proprietary name / brand Trexime 400mg capsule
name
Strength/concentration of drug of Each capsule contains:
Active Pharmaceutical ingredient Cefixime as trihydrate…400mg
(API) per unit
Reference to Finished product JP
specifications
The status in reference regulatory SUPRAX 400 mg CAPSULE by SANOFI Aventis , Spain
authorities Approved
For generic drugs (me-too status) Cefiget 400 mg Capsule by M/s GETZ Pharma
GMP status of the Finished product 15-1-2020, Overall hygienic condition of the firm is satisfactory at
manufacturer the time of inspection. Firm has cephalosporin capsule section.
Name and address of API M/s. Pharmagen Ltd Kot nabi Kuksh wala, 34km ferozpur road
manufacturer. Lahore.
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO QOS-PD template. Firm has
summarized information related to nomenclature, structure,
general
Characterization, specifications, analytical procedures and its
reference standard, container closure system and stability studies
of drug 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
validation/verification of analytical procedures, batch analysis,
justification of specifications, reference standard or materials,
Module-III (Drug Product): Firm has submitted relevant information against the Module III,
including, Comparative dissolution studies (reference product is
cefspan capsule) Process validation protocol, Finished product
analytical method validation report & stability studies data.
Manufacturer of API M/s. Pharmagen Ltd Kot nabi Kuksh wala, 34km ferozpur road Lahore.
API Lot No. 00244-043-2020
Description of Pack
Blister
Real Time: 0, 3, 6, (Months)
Batch No. ZT01 ZT02 ZT03
Batch Size 5000cap 5000cap 5000cap
No. of Batches 03
1. Reference of previous approval of  N/A
the firm (if any)
2. Approval of API/ DML/GMP certificate GMP certificate was issued to M/s Pharmagen Ltd based on
of API manufacturer issued by evaluation conducted on 8-1-2019.
concerned regulatory authority of
country of origin.
3. Documents for the procurement of API Invoice from Pharmagen Ltd specifying purchase of cephradine
with approval from DRAP (in case of 25Kg is provided.
import).
4. Data of stability batches will be Firm has submitted record of testing of all batches along with
supported by attested respective chromatograms, raw data sheets, COA and summary data sheets.
documents like chromatograms, The firm has2 Galvano Scientific stability chambers, Model STC-
Raw data sheets, COA, summary data SS-400-LAC with 400liter capacity
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 and
temperature and humidity monitoring of humidity monitoring of real time and accelerated stability
stability chambers (real chambers
time and accelerated) (VI)
Decision of 308th meeting: Registration Board deferred the case for further deliberation regarding finished
product specifications of applied formulation/strength.
Firm’s reply: Firm has submitted drug product specifications as per monograph approved by Registration Board
vide No. F.14-1/2022-PEC along with fee of RS. 7,500/- for each strength.
Decision: Registration Board approved the applications of “Trexime 200mg capsule” &” Trexime 400mg
capsule” as per monograph approved by Registration Board vide No. F.14-1/2022-PEC
357. Name, address of Applicant / Marketing M/s Usawa Pharmaceuticals. 146 S.I.Z. Risalpur,
Authorization Holder KPK, Pakistan
☐ Importer
☐ Export sale
Evidence of approval of manufacturing Firm has submitted copy of section approval letter
facility dated 23-07-2012 which specifiesLyophilized vials
(General) for M/s Bio-Labs Pharma
The proposed proprietary name / brand
UswaTig 50mg Injection
name
Pharmaceutical ingredient (API) per unit Tigecycline (Lyophilized powder)………50mg
Pharmaceutical form of applied drug Lyophilized Powder for Injection
Pharmacotherapeutic Group of (API) Antibacterial agent
Reference to Finished product
USP
specifications
The status in reference regulatory
Approved by US FDA
authorities
For generic drugs (me-too status) Tigewel Injection of M/s Welwrd Pharma (Reg.#
082530)
GMP status of the Finished product GMP certificate issued on 13-08-2020.
manufacturer
Name and address of API manufacturer. Fuan Pharmaceutical Group Chongqing Bosen
Pharmaceutical Co. Ltd .No .1 human Yi Road,
Changshou District, Chongqing 401254,P.R China.
template.
Firm has summarized information related to
Characterization, specifications, analytical
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/verification of
Module III (Drug Substance) Firm has submitted detailed data for both drug
substance data related to nomenclature, structure,
substance.
Real time: 6oC ± 2 oC, RH for 36 months
Accelerated: 25oC ± 2oC/60% ± 5%RH for 6 months
Batches: (Til00701V, Til00702V, Til00703V)

product.
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. BTig 50mg injection by
Bosch pharmaceuticals.
Analytical method validation/verification Method verification studies have been submitted.
of product
Manufacturer of API Fuan Pharmaceutical Group Chongqing Bosen
Pharmaceutical Co. Ltd. No .1 human Yi Road,
Changshou District, Chongqing 401254, P.R China.
API Lot No. Ti191201
Description of Pack
Glass vial
Real Time: 0, 3, 6 ,9,12,18,24(Months)
Batch No. L-131 L-138 L-242
Batch Size 1000 Vials 1000 Vials 700 vials
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 Firm has submitted copy of GMP certificate (No.
of API manufacturer issued by concerned CQ20180031) issued by Chongqing food and drug
regulatory authority of country of origin. administration valid upto 09-10-2023.
3. Documents for the procurement of API  Firm has submitted copy of Licenses to Import
with approval from DRAP (in case of Drug substance Tigecycline issued by AD I&E
import). DRAP, Islamabad dated 05-08-2019 & 02-04-2020.
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 software NA
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).
 3.2. S.4 limits for test of pH submitted in the drug  Firm has submitted revised
Acceptance
substance specifications is not as per the USP documents submitted without
monograph for “Tigecycline”. justifying the deviations observed
 The details of coloumn temperature, mobile phase in previously submitted data.
preparation, system suitability solution mentioned in the  Temperature for autosampler not
Assay test method by Drug substance manufacturer is reflected in analytical method.
not as per the USP monograph for “Tigecycline”.  Firm has submitted Bioburden test
 Submitted COA from M/s Bio-labs reflect that tests of report from M/s Bio Lab for another
Bacterial Endotoxin & sterility have not been batch than that submitted earlier.
performed.  Drug substance specifications and
 Copies of the Drug substance specifications and analytical procedure has been
analytical procedures used for routine testing of the submitted from M/s Bio-Labs, but
Drug substance /Active Drug Product manufacturer is these documents are not formal and
required. does not bear any document no.,
 Analytical Method Verification studies including issue date or effective date.
specificity, accuracy and repeatability (method  Analytical method verification
precision) performed by the Drug Product manufacturer studies have been submitted from
shall be submitted. M/s Bio-Labs.
 Provide results of analysis of relevant batch(es) of Drug  COA from API manufacturer has
Substance performed by Drug Product manufacturer been submitted, which declares the
used during product development and stability studies, product name as “Tigecycline
along with Certificate of Analysis (CoA) of the same lyophilized”, whereas COA of M/s
batch from Drug Substance / /Active Pharmaceutical Bio-Lab declares it as
Ingredient manufacture. “Tigecycline” only.
 Evidence of availability of Auto sampler in HPLC,  No Evidence of availability of Auto
wherein 10oC temperature conditions could be sampler in HPLC, wherein 10oC
maintained. temperature conditions could be
maintained.
 COA S.5 primary / secondary reference standard COA of working standard has been
3.2.of
including source and lot number shall be provided. submitted from M/s Fuan
Pharmaceutical, China.
3.2. S.7  The USP monograph for Firm has submitted stability studies
“Tigecycline” recommends storage data of drug substance for the same
condition as at refrigerated batches as submitted earlier, wherein
temperature, whereas stability only conditions of storage have been
studies data has been submitted as per changed as reuired for a refrigerated
room temperature conditions. item, while the analytical values for all
 Specifications for pH & specific the tests are same as presented earlier.
optical rotation applied in stability
studies is different from that
submitted in section 3.2.S.4.4.
3.2.P.1  Inclusion of lactose monohydrate in MHRA approved reference given.
the composition shall be justified
since innovator product approved by
US FDA & EMA is formulated
without use of any excipient.
3.2.P.2.1  Compatibility studies of the Drug MHRA approved reference given.
Substance(s) with Lactose shall be
provided since innovator product
approved by US FDA & EMA is
formulated without use of any
excipient.
 3.2. P.5 of fill weight/vial shall be submitted.
Specifications Following not given
 Specifications does not include test of Specifications
“Particulate of fill weight/vial shall be submitted.
matter”.  Evidence of availability of Auto sampler in HPLC,
 Evidence of availability of Auto samplerwherein in HPLC, 10oC temperature conditions could be
wherein 10oC temperature conditions maintained. could be
maintained.  Peak integration is not proper, since it does not
 Precision parameter has not been performed coincidein with
the the base line.
analytical method verification studies.  Documents are not formal and does not bear any
 COAs of relevant batches for which stabilitydocument no., issue date or effective date.
studies data
has been submitted, shall be provided.  Submitted COAs does no tinclude test of particulate
matter as recommended by the USP monograph of
“Tiogecycline for injection”
 3.2.P.6 working standard COA reflect date of COA of working standard submitted
Submitted
analysis as 14-12-2019, whereas stability batches have with date of analysis as 25-12-2017,
been analysed prior to this date. wherein the reference standard (lot#
F0M325) used for its standardization
was valid upto 30-09-2017.
 Firm3.2. P.8submitted copy of Licenses to Import
has InvoicesDrug
shared are still subsequent to the date of
substance Tigecycline issued by AD I&E manufacturing
DRAP, of two batches. i.e. L-131 & L-138
Islamabad dated 05-08-2019 & 02-04-2020, with whereas
manufacturing date of 03-2018, whereas
stability batches have been manufactured priorsubmitted
to these
invoice is of 08-2019.
dates.  Submitted invoice is for “Tigecycline lyophilized”.
 Clarification shall be submitted whether  Firm submitted
has submitted that provided data is of
stability studies data is of trial batches orcommercial
commercialbatches.
batches.  Raw data sheets submitted.
 Raw data sheets for stability studies, reflecting the
Revised stability study sheets have been submitted.
details of Standard weight, Sample dilution preparation,
Potency of Reference standard and Calculation formula
applied for the Assay test shall be submitted.
 As per submitted stability studies data, test of particulate
matter has not been performed, justification shall be
 Dates of testing written in the stability summary sheets
for different time points, does not relate with the relevant
duration in months.
 As per submitted BMRs potency  BMR was written with standard
adjustment has not been done for the batch formula and now it been
Drug substance, based upon the revised with potency adjustment as
actual Assay results. per potency of drug substance.
 As per submitted BMRs, lactose  Revised BMR mentions the
monohydrate has been used in the dispensed quantity of API on the
formulation, whereas innovator basis of 99% potency, whereas
product has been formulated without asper submitted COA of drug
use of any excipient. Justification substance from M/s Bio-Labs, the
shall be submitted in this regard. potency of API is 98.4% on as is
 Details of the minimum handling basis.
capacity of the compounding vessel  Submitted BMRs does not reflect
used for manufacturing of stability any test of filled weight per vial,
batches shall be submitted shall be sterility testing at any stage.
submitted.  Details of the minimum handling
 Submitted BMRs have not been filled capacity of the compounding vessel
completely. used for manufacturing of stability
batches have not been submitted.
Decision of 316th meeting: Deferred for following:
 Submission of formal documents for drug substance specifications & analytical procedures form M/s
Bio-Labs, wherein details of document no., issue date or effective date shall have been mentioned.
 Evidence of availability of Auto sampler in HPLC, wherein 10 oC temperature conditions could be
maintained.
 Firm has submitted stability studies data of drug substance for the same batches as submitted earlier,
wherein only conditions of storage have been changed as required for a refrigerated item, while the
analytical values for all the tests are same as presented earlier.
 Specifications of fill weight/vial shall be submitted.
 Peak integration is not proper, since it does not coincide with the base line.
 Submitted commercial invoices for the procurement of drug substance are still subsequent to the date
of manufacturing of two batches. i.e. L-131 & L-138 with manufacturing date of 03-2018, whereas
submitted invoice is of 08-2019.
 Scientific justification shall be submitted for use of Lyophilized powder of drug substance for the
manufacture of finished drug product by way of lyophilization.
 Revised BMR mentions the dispensed quantity of API on the basis of 99% potency, whereas as per
submitted COA of drug substance from M/s Bio-Labs, the potency of API is 98.4% on as is basis.
 Submitted BMRs does not reflect any test of filled weight per vial, sterility testing at any stage.
 Details of the minimum handling capacity of the compounding vessel used for manufacturing of
stability batches have not been submitted.
 Submitted COAs of drug product does not include test of particulate matter as recommended by the
USP monograph of “Tigecycline for injection”
Firm’s reply:
Observation Firm’s Reply
 Submission of formal documents for Firm has submitted analytical procedure,
drug substance specifications & wherein mobile phase composition is
analytical procedures form M/s Bio- different from that proposed by the drug
Labs, wherein details of document no., substance manufcaturer.
issue date or effective date shall have
been mentioned.
Evidence of availability of Auto sampler in Fimr has submitted specification sof of
HPLC, wherein 10oC temperature auto sampler assembled with HPLC of
conditions could be maintained. Perkin Almer 200LC, wherein operating
conditions for “Ambient temperature” are
mentioned as 10- 30oC.
Firm has submitted stability studies data of The stability data has been done as per
drug substance for the same batches as recommended storage conditions. There
submitted earlier, wherein only conditions was typographic error in the data.
of storage have been changed as required
for a refrigerated item, while the analytical
values for all the tests are same as presented
earlier.
Specifications of fill weight/vial shall be The product is in lyophilized form. For this
submitted. 2 ml solution per vial was filled and then
lyophilized.
It is pertinent to mention that vials are
filled with 2 ml solution at an intermediate
stage, whereas final dosage form of the
applied product is in the powder form
hence fill weight specifications are
necessary to establish uniformity of
dosage.
Peak integration is not proper, since it does Firm has submitted chromatograms again
not coincide with the base line. with justification that the attenuation is
increased which results in the proper
coinciding of baseline.
 Submitted commercial invoices for the No reply submitted.
procurement of drug substance are still
subsequent to the date of
manufacturing of two batches. i.e. L-
131 & L-138 with manufacturing date
of 03-2018, whereas submitted invoice
is of 08-2019.
 Scientific justification shall be The bulk and raw material of tigecycline is
submitted for use of Lyophilized also available in lyophilized/sterilized
powder of drug substance for the form. The raw material was then
manufacture of finished drug product formulated into solution form which is
by way of lyophilization. then filled and lyophilized.
 Revised BMR mentions the dispensed Firm has declared it as a typographic error,
quantity of API on the basis of 99% and has submitted revised COA of drug
potency, whereas as per submitted substance wherein Assay value has been
COA of drug substance from M/s Bio- declared as 99% on anhydrous basis,
Labs, the potency of API is 98.4% on which still does not justify the dispensed
as is basis. amount on basis of “as is potency”, since
water content has been declared as 1.3%.
Submitted BMRs does not reflect any test The solution is filled in the vials. The
of filled weight per vial, sterility testing at volume variation/checklist is attached.
any stage
 Details of the minimum handling The solution is filled in glass beaker (5Ltr)
capacity of the compounding vessel whose minimum handling capacity is
used for manufacturing of stability 500ml.
Submitted COAs of drug product does not Firm has submitted revised COAs of drug
include test of particulate matter as product for complete stability studies,
recommended by the USP monograph of wherein test of “Particular matter” has now
“Tigecycline for injection”. been included.
th
Decision of 320 meeting: Deferred for following:
 Submission of commercial invoices attested by AD DRAP I&E, for the procurement of drug
substance used to manufacture drug product batches. i.e. L-131 & L-138.
 Specifications for the fill weight/vial shall be submitted.
 Evidence of performance of sterility testing at the time of batch release shall be submitted.
 Scientific justification shall be submitted for using glass beaker (5Ltr) for the compounding the
commercial scale batches.
 Verification of the claim of the firm regarding submitted HPLC chromatograms that “attenuation is
increased which results in the proper coinciding of baseline.”
 Firm has submitted copy of license to import issued by AD I&E Islamabad dated 20-12-2017 for
import of 200gm of Tigecycline.
 The product is filled with a fill volume of 2ml+ 0.2ml solution for lyophilisation, after
lyophilisation dried cake is formed.
 Microbiological reports for the sterility testing for batch release of stability batches.
 The product is commercially manufactured with a batch size of approx. 2litre so it is
manufactured in a 5litre glass beaker as per proper manufacturing procedure.
 As the attenuation or scale of the y-axis is changed the baseline is automatically changed as shown
in the attached chromatograms.
Decision: Approved.
358. Name, address of Applicant / Marketing M/s Gray's Pharmaceuticals. Plot No. 2, street
Authorization Holder No.N-3, National Industrial Zone, Rawat
Islmabad.
☐ Importer
☐ Export sale
Bacticil 50mg Injection IV
name
Pharmaceutical ingredient (API) per unit Tigecycline (Lyophilized powder) ……… 50mg
USP
specifications
Approved by US FDA
authorities
082530)
manufacturer
template.
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
validation/verification of analytical procedures, batch
analysis, justification of specifications, reference
standard or materials, container closure system and
stability.
substance.
Real time: 6oC ± 2 oC,RH for 36 months
product.
of product
Changshou District, Chongqing 401254, P.R
China.
Description of Pack
Glass vial
Real Time: 0, 3, 6 ,9,12,18,24(Months)
Batch No. L-131 L-138 L-242
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP Firm has submitted copy of GMP certificate (No.
certificate of API manufacturer issued CQ20180031) issued by Chongqing food and drug
by concerned regulatory authority of administration valid upto 09-10-2023.
country of origin.

etc.

testing
temperature and humidity monitoring temperature and humidity monitoring of real time and
of stability chambers (real time and accelerated stability chambers.
accelerated).
 Acceptance limits for test of pH submitted in the drug  Firm has submitted revised
3.2. S.4
substance specifications is not as per the USP documents submitted without
monograph for “Tigecycline”. justifying the deviations observed
 The details of coloumn temperature, mobile phase in previously submitted data.
preparation, system suitability solution mentioned in the  Temperature for autosampler not
Assay test method by Drug substance manufacturer is reflected in analytical method.
not as per the USP monograph for “Tigecycline”.  Firm has submitted Bioburden test
 Submitted COA from M/s Bio-labs reflect that tests of report from M/s Bio Lab for another
Bacterial Endotoxin & sterility have not been batch than that submitted earlier.
performed.  Drug substance specifications and
 Copies of the Drug substance specifications and analytical procedure has been
analytical procedures used for routine testing of the submitted from M/s Bio-Labs, but
Drug substance /Active Drug Product manufacturer is these documents are not formal and
required. does not bear any document no.,
 Analytical Method Verification studies including issue date or effective date.
specificity, accuracy and repeatability (method  Analytical method verification
precision) performed by the Drug Product manufacturer studies have been submitted from
shall be submitted. M/s Bio-Labs.
 Provide results of analysis of relevant batch(es) of Drug  COA from API manufacturer has
Substance performed by Drug Product manufacturer been submitted, which declares the
used during product development and stability studies, product name as “Tigecycline
along with Certificate of Analysis (CoA) of the same lyophilized”, whereas COA of M/s
batch from Drug Substance / /Active Pharmaceutical Bio-Lab declares it as
Ingredient manufacture. “Tigecycline” only.
 Evidence of availability of Auto sampler in HPLC,  No Evidence of availability of Auto
wherein 10oC temperature conditions could be sampler in HPLC, wherein 10oC
maintained. temperature conditions could be
maintained.
 COA of primary / secondary reference standard COA of working standard has been
3.2.S.5
including source and lot number shall be provided. submitted from M/s Fuan
Pharmaceutical, China.
condition as at refrigerated batches as submitted earlier, wherein
temperature, whereas stability only conditions of storage have been
studies data has been submitted as per changed as required for a refrigerated
room temperature conditions. item, while the analytical values for all
studies is different from that
submitted in section 3.2.S.4.4.
3.2.P.1  Inclusion of lactose monohydrate in MHRA approved reference given.
the composition shall be justified
since innovator product approved by
US FDA & EMA is formulated
without use of any excipient.
formulated without use of any
excipient.
3.2. P.5  Specifications of fill weight/vial  Following not given
shall be submitted.  Specifications of fill
 Specifications does not include weight/vial shall be submitted.
test of “Particulate matter”.  Evidence of availability of
 Evidence of availability of Auto Auto sampler in HPLC, wherein 10oC
sampler in HPLC, wherein 10oC temperature conditions could be
temperature conditions could be maintained.
maintained.  Peak integration is not proper,
 Precision parameter has not been since it does not coincide with the base
performed in the analytical method line.
verification studies.  Documents are not formal and
 COAs of relevant batches for does not bear any document no., issue
which stability studies data has been date or effective date.
submitted, shall be provided.  Submitted COAs does not
include test of particulate matter as
recommended by the USP monograph
of “Tiogecycline for injection”
3.2.P.6  Submitted working standard COA of working standard submitted
COA reflect date of analysis as 14-12- with date of analysis as 25-12-2017,
2019, whereas stability batches have wherein the reference standard (lot#
been analysed prior to this date. F0M325) used for its standardization
3.2. P.8  Firm has submitted copy of  Invoices shared are still
Licenses to Import Drug substance subsequent to the date of
Tigecycline issued by AD I&E DRAP, manufacturing of two batches. i.e. L-
Islamabad dated 05-08-2019 & 02-04- 131 & L-138 with manufacturing date
2020, whereas stability batches have of 03-2018, whereas submitted
been manufactured prior to these dates. invoice is of 08-2019.
 Clarification shall be submitted  Submitted invoice is for
whether submitted stability studies data “Tigecycline lyophilized”.
is of trial batches or commercial batches.  Firm has submitted that
 Raw data sheets for stability provided data is of commercial
studies, reflecting the details of Standard batches.
weight, Sample dilution preparation,  Raw data sheets submitted.
Potency of Reference standard and  Revised stability study sheets
Calculation formula applied for the have been submitted.
Assay test shall be submitted.
 As per submitted stability studies
data, test of particulate matter has not
been performed, justification shall be
 Dates of testing written in the
stability summary sheets for different
time points, does not relate with the
relevant duration in months.
adjustment has not been done for the batch formula and now it has been
Drug substance, based upon the revised with potency adjustment as
actual Assay results. per potency of drug substance.
monohydrate has been used in the dispensed quantity of API on the
formulation, whereas innovator basis of 99% potency, whereas as
product has been formulated without per submitted COA of drug
use of any excipient. Justification substance from M/s Bio-Labs, the
shall be submitted in this regard. potency of API is 98.4% on as is
capacity of the compounding vessel  Submitted BMRs does not reflect
used for manufacturing of stability any test of filled weight per vial,
batches shall be submitted shall be sterility testing at any stage.
submitted.  Details of the minimum
 Submitted BMRs have not been filled handling capacity of the compounding
completely. vessel used for manufacturing of
stability batches have not been
submitted.
maintained.
Firm’s reply:
 Submission of formal documents for Firm has submitted analytical procedure;
Labs, wherein details of document no., substance manufacturer.
been mentioned.
Evidence of availability of Auto sampler in Fimr has submitted specification sof of
HPLC, wherein 10oC temperature auto sampler assembled with HPLC of
conditions could be maintained. Perkin Almer 200LC, wherein operating
earlier.
lyophilized.
dosage.
is of 08-2019.
manufacture of finished drug product formulated into solution from which is
any stage

commercial scale batches.
Decision: Approved.
359. Name, address of Applicant / Marketing M/s Novartana Pharmaceuticals (Pvt). Ltd 87-B
Authorization Holder Plot of Sundar Industrial Area, Raiwind Road,
Lahore Pakistan.
☐ Importer
☐ Export sale
Novartig 50mg IV Injection
name
Pharmaceutical ingredient (API) per unit Tigecycline (Lyophilized powder)………50mg
USP
specifications
Approved by US FDA
authorities
082530)
manufacturer
template.
substance. The firm has summarized
information of drug product including its description,
composition, pharmaceutical development,
analytical procedures, validation/verification of
substance.
Real time: 6oC ± 2 oC,RH for 36 months
product.
of product
Changshou District, Chongqing 401254, P.R
China.
Description of Pack
Glass vial
Real Time: 0, 3, 6 ,9,12,18,24(Months)
Batch No. L-131 L-138 L-242
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP Firm has submitted copy of GMP certificate (No.
certificate of API manufacturer issued CQ20180031) issued by Chongqing food and drug
by concerned regulatory authority of administration valid upto 09-10-2023.
country of origin.

etc.
testing
temperature and humidity monitoring temperature and humidity monitoring of real time and
of stability chambers (real time and accelerated stability chambers.
accelerated).
3.2. S.4  Acceptance limits for test of pH  Firm has submitted revised
submitted in the drug substance documents submitted without
specifications is not as per the USP justifying the deviations observed
monograph for “Tigecycline”. in previously submitted data.
 The details of coloumn  Temperature for autosampler not
temperature, mobile phase preparation, reflected in analytical method.
system suitability solution mentioned in  Firm has submitted Bioburden test
the Assay test method by Drug substance report from M/s Bio Lab for another
manufacturer is not as per the USP batch than that submitted earlier.
monograph for “Tigecycline”.  Drug substance specifications and
 Submitted COA from M/s Bio- analytical procedure has been
labs reflect that tests of Bacterial submitted from M/s Bio-Labs, but
Endotoxin & sterility have not been these documents are not formal and
performed. does not bear any document no.,
 Copies of the Drug substance issue date or effective date.
specifications and analytical procedures  Analytical method verification
used for routine testing of the Drug studies have been submitted from
substance /Active Drug Product M/s Bio-Labs.
manufacturer is required.  COA from API manufacturer has
 Analytical Method Verification been submitted, which declares the
studies including specificity, accuracy product name as “Tigecycline
and repeatability (method precision) lyophilized”, whereas COA of M/s
performed by the Drug Product Bio-Lab declares it as
manufacturer shall be submitted. “Tigecycline” only.
 Provide results of analysis of  No Evidence of availability of Auto
relevant batch(es) of Drug Substance sampler in HPLC, wherein 10oC
performed by Drug Product temperature conditions could be
manufacturer used during product maintained.
development and stability studies, along
with Certificate of Analysis (CoA) of the
same batch from Drug Substance /
/Active Pharmaceutical Ingredient
manufacture.
 Evidence of availability of Auto
sampler in HPLC, wherein 10oC
temperature conditions could be
maintained.
3.2.S.5  COA of primary / secondary COA of working standard has been
reference standard including source and submitted from M/s Fuan
lot number shall be provided. Pharmaceutical, China.
condition as at refrigerated temperature, batches as submitted earlier, wherein
whereas stability studies data has been only conditions of storage have been
submitted as per room temperature changed as reuired for a refrigerated
conditions. item, while the analytical values for all
studies is different from that submitted in
section 3.2.S.4.4.
3.2.P.1  Inclusion of lactose monohydrate MHRA approved reference given.
in the composition shall be justified since
innovator product approved by US FDA
& EMA is formulated without use of any
excipient.
formulated without use of any excipient.
3.2. P.5  Specifications of fillFollowing
weight/vial
not given
shall be submitted.  Specifications of fill weight/vial shall be submitted.
  Evidence
Specifications does not include
of availability of Auto sampler in HPLC,
test of “Particulate matter”. wherein 10oC temperature conditions could be
 Evidence of availability
maintained.
of Auto
sampler in HPLC, wherein 10oC
Peak integration is not proper, since it does not
temperature conditions coincide could withbe the base line.
maintained.  Documents are not formal and does not bear any
 Precision parameter document
has not been
no., issue date or effective date.
performed in the analytical method Submitted COAs does no tinclude test
verification studies. of particulate matter as recommended
 COAs of relevant batches for by the USP monograph of
which stability studies data has been “Tiogecycline for injection”
submitted, shall be provided.
3.2.P.6  Submitted working standard COA of working standard submitted
COA reflect date of analysis as 14-12- with date of analysis as 25-12-2017,
2019, whereas stability batches have wherein the reference standard (lot#
been analysed prior to this date. F0M325) used for its standardization
3.2. P.8  Firm has submitted Invoicescopy shared
of are still subsequent to the date of
Licenses to Import Drugmanufacturingsubstance of two batches. i.e. L-131 & L-138
Tigecycline issued by AD with I&E manufacturing
DRAP, date of 03-2018, whereas
Islamabad dated 05-08-2019 submitted
& 02-04-
invoice is of 08-2019.
 Submitted invoice is for “Tigecycline lyophilized”.
2020, whereas stability batchesFirm has havesubmitted that provided data is of
been manufactured prior to these dates. batches.
commercial
  be
Clarification shall Rawsubmitted
data sheets submitted.
whether submitted stability Revised data
studies stability study sheets have been submitted.
is of trial batches or commercial batches.
 Raw data sheets for stability
studies, reflecting the details of Standard
weight, Sample dilution preparation,
Potency of Reference standard and
Calculation formula applied for the
Assay test shall be submitted.
 As per submitted stability studies
data, test of particulate matter has not
been performed, justification shall be
 Dates of testing written in the
stability summary sheets for different
time points, does not relate with the
relevant duration in months.
adjustment has not been done for the batch formula and now it sbeen
Drug substance, based upon the actual revised with potency adjustment as
Assay results. per potency of drug substance.
monohydrate has been used in the dispensed quantity of APi on the
formulation, whereas innovator product basis of 99% potency, whereas
has been formulated without use of any asper submitted COA of drug
excipient. Justification shall be submitted substance from M/s Bio-Labs, the
in this regard. potency of API is 98.4% on as is
capacity of the compounding vessel used  Submitted BMRs does not reflect
for manufacturing of stability batches any test of filled weight per vial,
shall be submitted shall be submitted. sterility testing at any stage.
 Submitted BMRs have not been Details of the minimum handling
filled completely. capacity of the compounding vessel
used for manufacturing of stability
maintained.
Firm’s reply:
 Submission of formal documents for Firm has submitted analytical procedure;
Labs, wherein details of document no., substance manufacturer.
been mentioned.
Evidence of availability of Auto sampler in Firm has submitted specifications of auto
HPLC, wherein 10oC temperature sampler assembled with HPLC of Perkin
conditions could be maintained. Almer 200LC, wherein operating
earlier.
lyophilized.
dosage.
is of 08-2019.
manufacture of finished drug product formulated into solution from which is
any stage

commercial scale batches as lyophilization is performed after filling the solution in vials.
Decision: Approved.
360. Name and address of manufacturer / M/s AGP (Private) Limited, B-23, S.I.T.E, Karachi
Applicant
Brand Name +Dosage Form + Strength Doxiproct Ointment
Diary No. Date of R& I & fee Dy.No: 335; Dated 21-010-2011, Rs.15000/-
Rs.35,000/- (05-09-2013) Photocopy
Composition Each gram contains:
Calcium Dobesilate…..40 mg
Lidocaine hydrochloride…….20 mg
Pharmacological Group Anti haemorrhoidals
Type of Form Form-5 D
Finished Product Specification Manufacturer’s specifications
Pack size & Demanded Price Pack size of 15gm; Rs. 300/-
Approval status of product in Reference Doxiproct – OM Pharma, approved by Swissmedic of Switzerland.
Regulatory Authorities.
Me-too status Not applicable
GMP status --
Previous Remarks of the Evaluator.  The firm has submitted 26 weeks Accelerated and 26 weeks of
Intermediate Stability Study Data for 03 Batches.
 Firm has performed test for Identification, Assay, Appearance,
Weight of filled tubes and Microbial testing only during
stability studies, whereas WHO guidelines for Stability testing
of active pharmaceutical ingredients and finished
pharmaceutical products recommends as under:
 “Topical preparations should be evaluated for clarity,
homogeneity, pH, suspendability (for lotions), consistency,
viscosity, particle size distribution (for suspensions, when
feasible), level of microbial contamination/sterility and weight
loss (when appropriate).” Also USP chapter <3> titled
“Topical and Transdermal Drug Products – Product Quality
Tests”, recommends tests for “Apparent viscosity” and
“Uniformity in Containers” as “Specific Tests For Topically
Applied Semisolid Drug Products.”
 GMP certificate of supplier of Lidocaine HCl is expired.
 Commercial invoice of Lidocaine has not been attested by
ADC DRAP.
 Commitment to follow Drug Specification Rules, 1978 has not
been submitted.
Previous Decision The case was initially presented in 259th meeting of Registration
Board wherein the case was deferred for submission of stability
data as per guidelines provided in 251st RB meeting.
In 272nd meeting of Registration Board the case was again
presented along with stability studies data, wherein Registration
Board deferred the case for following observations:
i. Firm has performed test for Identification, Assay,
Appearance, Weight of filled tubes and Microbial testing
only during stability studies, whereas WHO guidelines
for Stability testing of active pharmaceutical ingredients
and finished pharmaceutical products recommends as
under:
“Topical preparations should be evaluated for clarity,
homogeneity, pH, suspendability (for lotions),
consistency, viscosity, particle size distribution (for
suspensions, when feasible), level of microbial
contamination/sterility and weight loss (when
appropriate).” Also USP chapter <3> titled “Topical and
Transdermal Drug Products – Product Quality Tests”,
recommends tests for “Apparent viscosity” and
“Uniformity in Containers” as “Specific Tests For
Topically Applied Semisolid Drug Products.”
ii. GMP certificate of supplier of Lidocaine HCl is expired.
iii. Commercial invoice of Lidocaine has not been attested
by DRAP.
iv. Commitment to follow Drug Specification Rules, 1978
has not been submitted.
Evaluation of Firm’s reply Firm has replied as under:
i. “We conducted the study only for the major tests because
DRAP allows only limited quantity of APIs to be imported for
product development. Due to small batch size we cannot
perform analysis of all the required tests but tests like clarity,
homogeneity and consistency have been covered in
appearance of the ointment.”
ii. Copy of GMP certificate of supplier of Lidocaine
hydrochloride i.e. M/s Gufic Life sciences Pvt. Ltd, Gujrat,
India issued by FDCA Gujarat has been submitted. The
certificate is valid upto 20-07-2019.
iii. “Regarding the purchase of Lidocaine hydrochloride, we
would like to inform you that our ordered quantity waqs very
small therefore the manufacturer M/s Gufic Biosciences Ltd,
India dispatched the material via DHL courier service. The
material directly received by us therefore we issued to obtain
the approval of ADC from local DRAP office.”
iv. Copy of DHL airway bill has been submitted in the name of
AGP (Pvt.) ltd. for Lidocaine hydrochloride.
v. Form 6 (License to import raw material for trial production,
test & analysis) has been submitted. The Form 6 has been
issued on 14-07-2017, whereas batch stability batches were
manufactured in October 2016.
vi. Commitment to follow Drug Specification Rules, 1978 has
been submitted.
Decision: Registration Board directed the firm to perform tests of “Apparent viscosity” and “Uniformity in
Containers” as recommended in USP chapter <3> titled “Topical and Transdermal Drug Products – Product
Quality Tests”.
Registration Board decided to constitute following panel for onsite investigation to confirm genuineness/
authenticity of stability data, including tests of “Apparent viscosity” and “Uniformity in Containers” as
recommended in USP chapter <3> titled “Topical and Transdermal Drug Products – Product Quality Tests” and
related documents, import of API, quality, specification, test analysis, facilities etc.
 Director DTL Quetta .
 Mr. Aslam Shah.
 Dr. Saif ur Rehman Khattak, FGA, CDL, Karachi.
M/s. AGP Limited, Karachi. – 02 Products
S. No. Molecule Brand Name of the Product

Calcium Dobesilate…………..40mg/g
96. Doxiproct Ointment
Lidocaine HCl…………………20mg/g
Background:
Registration Board in its 273rd Meeting directed the firm to perform tests of “Apparent viscosity” and “Uniformity
in Containers” as recommended in USP chapter <3> titled “Topical and Transdermal Drug Products – Product
Quality Tests”. Registration Board decided to constitute following panel for onsite investigation to confirm
genuineness/ authenticity of stability data, including tests of “Apparent viscosity” and “Uniformity in Containers”
as recommended in USP chapter <3> titled “Topical and Transdermal Drug Products – Product Quality Tests”
and related documents, import of API, quality, specification, test analysis, facilities etc.
Composition of Panel:
 Dr. Amanullah Khan, Director Drugs Testing Laboratory, Quetta.
 Dr. Saif-ur-Rehman Khattak, Federal Government Analyst, Central Drug Laboratory, Karachi.
 Mr. Aslam Shah, Senior Manager, Pharmacy & Purchase, Indus Hospital, Karachi.
Scope of investigation:
Investigation of the authenticity / genuineness of data (import of raw material and stability data), manufacturing
of stability batches and stability studies on these batches.
Tools for Investigation:
The investigation was conducted by using a structured questionnaire. Objective evidence was done via physical
inspection of the facilities for manufacturing and quality control, material used and retained, personnel involved,
ongoing studies, printed data and integrity and security of data in respective databases.
Detail of investigation has been summarized as under:

Q. No. Question Observation by panel
1. Do you have documents Calcium Dobesilate (already present in firm’s inventory since
confirming the import of used in an already registered product Doxium Capsules 500mg).
Calcium Dobesilate and However, Firm produced invoice (No. SI1016000559 dated
Lidocaine HCl APIs? 12.08.2016) of M/s OM pharma Switzerland, and furthermore
the firm on routine basis use to import Calcium Dobesilate for
their product Doxium Capsules 500mg. The firm has imported
390g of Lidocaine HCl API from Gufic Bioscience Ltd., India.
Firm has taken approval from DRAP.
2. What was the rationale The rationale behind selecting the API manufacturer for
behind selecting the Calcium Dobesilate is the GMP Compliance and the experience
particular manufacturer of for using the same API for their other registered product
APIs? DOXIUM CAPSULE 500mg. Lidocaine HCl imported from
M/s Gufic Bioscience Ltd., India which is GMP compliant
manufacturer.
3. Do you have documents The firm has produced documents confirming the import of
confirming the import of APIs and their working standards. However Impurities
Calcium Dobesilate and reference standards were not available.
Lidocaine HCl APIs and
reference standard and
impurity standards?
4. Do you have certificate of The firm has certificates of analysis for APIs and working
analysis of the APIs, standard of APIs only.
reference standards and
impurity standards?
5. Do you have any approval The firm has copy of GMP certificates of APIs manufacturer
of APIs or GMP certificateand approval by concerned regularity authority of country of
of APIs manufacturer origin.
issued by regulatory Calcium Dobesilate: Secretaria De Salud, Comision Federal De
authority of country of Proteccion Contra Reisgos Sanitarios, Mexico manufactured for
origin? OM Pharma Switzerland.
Lidocaine HCl: Commissioner Food & Drugs Control
Administration. Gujarat, India.
6. Do: you use APIs The APIs are compendial, the firm has used APIs’ Compendial
manufacturer method of method of testing as follows:
testing? Calcium Dobesilate E.P
Lidocaine HCl B.P
7. Do you have stability The firm has stability studies reports for both the APIs.
studies reports on APIs?
8. If yes, whether the The stability testing of APIs has been performed by
stability testing has been manufacturers as per SIM method and degradation products
performed as per SIM have also been quantified by the API manufacturers.
method and degradation
products have been
quantified?
9. Do you have method for The firm has method for quantifying the impurities in the APIs.
quantifying the impurities
in the APIs?
10. Do you have some The firm has remaining quantities of the APIs & working
remaining quantities of the standards of APIs only.
APIs, their reference
standard and impurities
standards?
11. Have you used The firm has used pharmaceutical grade excipients.
pharmaceutical grade
excipients?
12. Do you have documents Import documents for some of the excipients are available.
confirming the import of However, a few excipients were purchased from local markets.
the used excipients? Calcium Dobesilate : Import
Lidocaine HCl : Import
Polysorbatye 80 : Local Purchase
Propyl Gallate : Local Purchase
Buthylhydroxyanisole : Local Purchase
Anhydrous Citric Acid : Local Purchase
Cetyl Alcohol : Local Purchase
Polyethylene Glycol 300 : Local Purchase
Polyethylene Glycol 1500 : Import
Propylene Glycol : Local Purchase
13. Do you have test reports The firm has test reports and other records on the excipients
and other records on the used.
excipients used?
14. Do you have written and The firm has written and authorized protocols for the
authorized protocols for development of Doxiproct Ointment.
the development of
Doxiproct Ointment?
15. Have you performed The firm has not performed Drug-excipient compatibility
Drug-excipient studies as the composition of their ointment is similar to the
compatibility studies? innovator’s product Doxiproct Ointment. Manufactured by OM
Pharma, Switzerland.
16. Have you performed The firm has performed comparative studies in respect of the
comparative studies? following parameters against innovator product DOXIPROCT
Ointment, OM Pharma, Switzerland:
1. Physical Appearance
2. Viscosity
3. pH
4. Assay
The product of the firm has comparable results with the product
of innovator.
Furthermore, the following tests were also performed by the

firm as desired by the DRAP against letter No. F.1-1/2017/PEC-
DRAP (AD PEC-II).
Viscosity:
Viscosity
Batch
Results Limits
Number
(cp)
TR-135 28,500 26,000 – 35,000 cp at
TR-142 29,800 25°C,
TR-143 29,300 50rpm Spindle S-94
Uniformity in Containers:
Batch
API Top Middle Bottom Average
Number
Lidocaine
96.22% 96.13% 97.80% 96.72%
HCl
TR-135
Calcium
97.80% 97.85% 99.60% 98.42%
Dobesilate
Lidocaine
95.97% 97.44% 96.63% 96.68%
HCl
TR-142
Calcium
97.70% 99.19% 99.42% 98.44%
Dobesilate
Lidocaine
96.48% 95.65% 96.34% 96.16%
HCl
TR-143
Calcium
98.28% 97.44% 98.22% 97.98%
Dobesilate
17. Do you have product The firm has dedicated product development (R&D) section for
development (R&D) manufacturing of the product; however routine Quality Control
section? lab has been used for analysis purpose.
18. Do you have necessary The firm has necessary equipment available in product
equipment available in development section for development of Doxiproct Ointment
product development however routine Quality Control has been used for analysis
section for development of purpose.
Doxiproct Ointment?
19. Are the equipment in The equipment in product development section are qualified.
product development
section qualified?
20. Do you have proper The firm has proper maintenance / calibration / re-qualification
maintenance / calibration / program for the equipment used in Product Development
re-qualification program section.
for the equipment used in
PD section?
21. Do you have qualified The firm has three technical persons comprise of one Ph.D. and
staff in product two Pharm-Ds in manufacturing of New Products and three
development section with Chemists and one Pharm-D working on analytical side.
proper knowledge and
training in product
development?
22. Have you manufactured The firm has manufactured three stability batches for the
three stability batches for stability studies (at 40°C/75%RH, 30°C/65%RH and
the stability studies of 25°C/60%RH) of Doxiproct Ointment with batch number TR-
Doxiproct Ointment? 135, TR-142 and TR-143. Each batch has a size of 100 tubes of
15.0g.
23. What were the criteria for The criteria for fixing the batch size of stability batches is the
fixing the batch size of number of tubes required per testing with number of testing
stability batches? frequencies.
24. Do you have complete Batch manufacturing records for three (3) trial batches are
record of production of available.
stability batches?
25. Do you have protocols for The firm has detailed protocols for stability testing of stability
stability testing of stability batches.
batches?
26. Have you developed and The firm has developed and validated the method for testing of
validated the method for stability batches of finished product.
testing of stability
batches?
27. Do you have method Not applicable.
transfer studies in case
when the method of
testing being used by your
firm is given by any other
lab?
28. Do you have documents The firm has proper documents confirming the qualification of
confirming the equipment / instruments being used in the test and analysis of
qualification of equipment Calcium Dobesilate and Lidocaine HCl APIs and the finished
/ instruments being used in product Doxiproct Ointment.
the test and analysis of
Calcium Dobesilate and
Lidocaine HCl APIs and
the finished drug?
29. Do your method of The firm’s method of analysis is stability indicating.
analysis stability
indicating?
30. Do your HPLC software is HPLC software is 21CFR Compliant.
21CFR compliant?
31. Can you show Audit Trail Audit trail on the testing reports are available.
reports on Calcium
Dobesilate and Lidocaine
HCl testing?
32. Do you have some The firm has remaining quantities of stability batches for real
remaining quantities of time stability studies; however there is no quantity of degraded
degradation products and products.
stability batches?
33. Do you have commitment The firm has three commitment batches kept on stability testing
batches kept on stability for real time stability testing up to 24 months.
testing?
34. Do you have valid The firm has valid calibration status for the equipment used in
calibration status for the Doxiproct Ointment (Calcium Dobesilate and Lidocaine HCl)
equipment used in production and analysis.
Doxiproct (Calcium
Dobesilate and Lidocaine
HCl) Ointment production
in analysis?
35. Do proper and continuous The firm has adequate monitoring and control system for
monitoring and control are stability chamber.
available for stability
chamber?
36. Do related manufacturing Firm has renovated their ointment/cream manufacturing area;
area, equipment, however, this section still needs up gradation of HVAC system.
personnel and utilities be Secondary change proper installation of ointment filling
rated as GMP compliant? machine and utilities.
Conclusions:
On the basis of risk based approach the genuineness / authenticity of stability data submitted by the firm for
registration of Doxiproct Ointment (Calcium Dobesilate 40mg/g and Lidocaine HCl 20mg/g) is verifiable to
satisfactory level. However, the facilities related to ointment manufacturing area cannot be rated as GMP
compliant.
Decision of 276th meeting: Registration Board decided to defer the application for registration of “Doxiproct
Ointment (Calcium Dobesilate 40mg/g and Lidocaine HCl 20mg/g)” by M/s. AGP Limited, Karachi in view of
the fact that the facilities related to ointment manufacturing area cannot be rated as GMP compliant.
Firm’s response: Firm has submitted GMP certificate no. 30/2021-DRAP (K) issue don basis of inspection
conducted on 03-06-2021,including Semisolid (Cream/Ointment) section.
Decision: Approved with Innovator’s specifications. The firm shall submit 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 07-05-2021, before issuance of registration letter.
361. Name and address of manufacturer / M/s AGP (Private) Limited, B-23, S.I.T.E, Karachi
Applicant
Brand Name +Dosage Form + Strength Doxiproct Plus Ointment
Diary No. Date of R& I & fee Dy.No: 334; Dated 21-010-2011, Rs.15000/-
Rs.35,000/- (02-08-2013)
Calcium Dobesilate…..40 mg
Lidocaine hydrochloride…….20 mg
Pharmacological Group Anti haemorrhoidals
Type of Form Form-5 D
Finished Product Specification Manufacturer’s specifications
Pack size & Demanded Price Rs. 240/-
Approval status of product in Reference Doxiproct plus ointment– OM Pharma, approved by Swissmedic
Regulatory Authorities. of Switzerland.
GMP status --
Previous Remarks of the Evaluator.  The firm has submitted 26 weeks Accelerated and 26 weeks of
Intermediate Stability Study Data for 03 Batches.
 There is a significant change in Assay results of
Dexamethasone in accelerated stability studies of Batch#.
TR-144 i.e. initial results were 107.17% while those at 4th
week were 93.12%.
week were 94.28%.
week were 94.98%.
 Firm has performed test for Identification, Assay, Appearance,
Weight of filled tubes and Microbial testing only during
stability studies, whereas WHO guidelines for Stability testing
of active pharmaceutical ingredients and finished
pharmaceutical products recommends as under:
 “Topical preparations should be evaluated for clarity,
homogeneity, pH, suspendability (for lotions), consistency,
viscosity, particle size distribution (for suspensions, when
feasible), level of microbial contamination/sterility and weight
loss (when appropriate).” Also USP chapter <3> titled
“Topical and Transdermal Drug Products – Product Quality
Tests”, recommends tests for “Apparent viscosity” and
“Uniformity in Containers” as “Specific Tests For Topically
Applied Semisolid Drug Products.”
 GMP certificate of supplier of Lidocaine HCl is expired.
 Commercial invoices for Lidocaine HCl have not been attested
by ADC DRAP.
 Commitment to follow Drug Specification Rules, 1978 has not
been submitted.
Previous Decision The case was initially presented in 256th meeting of Registration
Board wherein the case was deferred for submission of stability
data as per guidelines provided in 251st RB meeting.
In 272nd meeting of Registration Board the case was again
presented along with stability studies data, wherein Registration
Board deferred the case for following observations:
i. Firm has performed test for Identification, Assay,
Appearance, Weight of filled tubes and Microbial testing
only during stability studies, whereas WHO guidelines
for Stability testing of active pharmaceutical ingredients
and finished pharmaceutical products recommends as
under:
“Topical preparations should be evaluated for clarity,
homogeneity, pH, suspendability (for lotions),
consistency, viscosity, particle size distribution (for
suspensions, when feasible), level of microbial
contamination/sterility and weight loss (when
appropriate).” Also USP chapter <3> titled “Topical and
Transdermal Drug Products – Product Quality Tests”,
recommends tests for “Apparent viscosity” and
“Uniformity in Containers” as “Specific Tests For
Topically Applied Semisolid Drug Products.”
ii. GMP certificate of supplier of Lidocaine HCl is expired.
iii. Commercial invoice of Lidocaine has not been attested
by DRAP.
iv. Commitment to follow Drug Specification Rules, 1978
has not been submitted.
Evaluation of Firm’s reply Firm has replied as under:
i. “We conducted the study only for the major tests because DRAP
allows only limited quantity of APIs to be imported for product
development. Due to small batch size we cannot perform analysis
of all the required tests but tests like clarity, homogeneity and
consistency have been covered in appearance of the ointment.”
ii. Copy of GMP certificate of supplier of Lidocaine hydrochloride
i.e. M/s Gufic Life sciences Pvt. Ltd, Gujrat, India issued by FDCA
Gujarat has been submitted. The certificate is valid upto 20-07-
2019.
iii. “Regarding the purchase of Lidocaine hydrochloride, we would
like to inform you that our ordered quantity was very small
therefore the manufacturer M/s Gufic Biosciences Ltd, India
dispatched the material via DHL courier service. The material
directly received by us therefore we issued to obtain the approval
of ADC from local DRAP office.”
iv. Form 6 (License to import raw material for trial production, test &
analysis) has been submitted. The Form 6 has been issued on 14-
07-2017, whereas batch stability batches were manufactured in
October 2016.
v. Commitment to follow Drug Specification Rules, 1978 has been
submitted.
Decision:
Registration Board directed the firm to perform tests of “Apparent viscosity” and “Uniformity in Containers” as
recommended in USP chapter <3> titled “Topical and Transdermal Drug Products – Product Quality Tests”.
Registration Board decided to constitute the following panel for onsite investigation to confirm genuineness/
authenticity of stability data, including tests of “Apparent viscosity” and “Uniformity in Containers” as
recommended in USP chapter <3> titled “Topical and Transdermal Drug Products – Product Quality Tests” and
related documents, import of API, quality, specification, test analysis, facilities etc.
 Director DTL Quetta .
 Mr. Aslam Shah.
 Dr. Saif ur Rehman Khattak, FGA, CDL, Karachi.
S. No. Molecule Brand Name of the Product

Calcium Dobesilate…………..40mg/g
97. Lidocaine HCl…………………20mg/g Doxiproct Plus Ointment
Dexamethasone Acetate………0.25mg/g
Background:
Registration Board in its 273rd Meeting directed the firm to perform tests of “Apparent viscosity” and “Uniformity in
Containers” as recommended in USP chapter <3> titled “Topical and Transdermal Drug Products – Product Quality
Tests”. Registration Board decided to constitute the following panel for onsite investigation to confirm genuineness /
authenticity of stability data, including tests of “Apparent viscosity” and “Uniformity in Containers” as recommended
in USP chapter <3> titled “Topical and Transdermal Drug Products – Product Quality Tests” and related documents,
import of API, quality, specification, test analysis, facilities etc.
Composition of Panel:
 Dr. Amanullah Khan, Director Drugs Testing Laboratory, Quetta.
 Dr. Saif-ur-Rehman Khattak, Federal Government Analyst, Central Drug Laboratory, Karachi.
 Mr. Aslam Shah, Senior Manager, Pharmacy & Purchase, Indus Hospital, Karachi.
Scope of investigation:
Investigation of the authenticity / genuineness of data (import of raw material and stability data), manufacturing of
stability batches and stability studies on these batches.
Tools for Investigation:

The investigation was conducted by using a structured questionnaire. Objective evidence was done via physical
inspection of the facilities for manufacturing and quality control, material used and retained, personnel involved,
ongoing studies, printed data and integrity and security of data in respective databases.
Detail of investigation has been summarized as under:

Q. Question Observation by panel
1. Do you have documents Calcium Dobesilate (already present in firm’s inventory since
confirming the import of used in an already registered product Doxium Capsules 500mg).
Calcium Dobesilate, However, Firm produced invoice (No. SI1016000559 dated
Lidocaine HCl and 12.08.2016) of M/s OM pharma Switzerland, and furthermore the
Dexamethasone Acetate firm on routine basis use to import Calcium Dobesilate for their
APIs? product Doxium Capsules 500mg. The firm has imported 390g of
Lidocaine HCl API from Gufic Bioscience Ltd., India and
Dexamethasone Acetate 5.0g from Zhejiang Xianju
pharmaceutical Co. Firm has taken approval of both APIs from
DRAP.
2. What was the rationale The rationale behind selecting the API manufacturer for Calcium
behind selecting the Dobesilate is the GMP Compliance and the experience for using
particular manufacturer the same API for their other registered product DOXIUM
of APIs? CAPSULE 500mg. Lidocaine HCl imported from M/s Gufic
Bioscience Ltd., India is GMP compliant and similarly the
Dexamethasone Acetate imported from M/s Zhejiang Xianju
pharmaceutical Co., China which is GMP compliant
manufacturer.
3. Do you have documents The firm has produced documents confirming the import of APIs
confirming the import of and their working standards. However Impurities reference
Calcium Dobesilate, standards were not available.
Lidocaine HCl and
Dexamethasone Acetate
APIs and reference
standard and impurity
standards?
4. Do you have certificate The firm has certificates of analysis for APIs and working
of analysis of the APIs, standard of APIs only.
reference standards and
impurity standards?
5. Do you have any The firm has copy of GMP certificates of APIs manufacturer and
approval of APIs or approval by concerned regularity authority of country of origin.
GMP certificate of APIsCalcium Dobesilate: Secretaria De Salud, Comision Federal De
manufacturer issued by Proteccion Contra Reisgos Sanitarios, Mexico manufactured for
regulatory authority ofOM Pharma Switzerland.
country of origin? Dexamethason Acetate: China Food and Drug Administration.
Lidocaine HCl: Commissioner Food & Drugs Control
Administration. Gujarat, India.
6. : Do you use APIs The APIs are compendial, the firm has used APIs’ Compendial
manufacturer method of method of testing as follows:
testing? Calcium Dobesilate E.P
Lidocaine HCl B.P
Dexamethasone Acetate B.P
7. Do you have stability The firm has stability studies reports for all the three APIs.
studies reports on APIs?
8. If yes, whether the The stability testing of APIs has been performed by manufacturers
stability testing has been as per SIM method and degradation products have also been
performed as per SIM quantified by the API manufacturers.
method and degradation
products have been
quantified?
9. Do you have method for The firm has method for quantifying the impurities in the APIs.
quantifying the
impurities in the APIs?
10. Do you have some The firm has remaining quantities of the APIs & working
remaining quantities of standards of APIs only.
the APIs, their reference
standard and impurities
standards?
11. Have you used The firm has used pharmaceutical grade excipients.
pharmaceutical grade
excipients?
12. Do you have documents Import documents for some of the excipients are available.
confirming the import of However, a few excipients were purchased from local markets.
the used excipients? Calcium Dobesilate : Import
Lidocaine HCl : Import
Dexamethasone Acetate : Import
Polysorbatye 80 : Local Purchase
Propyl Gallate : Local Purchase
Buthylhydroxyanisole : Local Purchase
Anhydrous Citric Acid : Local Purchase
Cetyl Alcohol : Local Purchase
Polyethylene Glycol 300 : Local Purchase
Propylene Glycol : Local Purchase
13. Do you have test reports The firm has test reports and other records on the excipients used.
and other records on the
excipients used?
14. Do you have written and The firm has written and authorized protocols for the development
authorized protocols for of Doxiproct Plus Ointment.
the development of
Doxiproct Plus
Ointment?
15. Have you performed The firm has not performed Drug-excipient compatibility studies
Drug-excipient as the composition of their ointment is similar to the innovator’s
compatibility studies? product Doxiproct Plus Ointment. Manufactured by OM Pharma,
Switzerland.
16. Have you performed The firm has performed comparative studies in respect of the
comparative studies? following parameters against innovator product DOXIPROCT
Plus Ointment, OM Pharma, Switzerland:
1. Physical Appearance
2. Viscosity
3. pH
4. Assay
The product of the firm has comparable results with the product
of innovator.
Furthermore, the following tests were also performed by the firm
as required by the DRAP against letter No. F.1-1/2017/PEC-
DRAP (AD PEC-II).
Viscosity:
Batch Viscosity Results
Limits
Number (cp)
TR-144 32,300 26,000 – 35,000 cp at
TR-145 31,100 25°C,
TR-146 30,800 50rpm Spindle S-94
Uniformity in Containers:
Batch
API Top Middle Bottom Average
Number
Lidocaine HCl 95.55% 95.60% 95.32% 95.49%
Calcium
TR-144 97.22% 96.51% 96.50% 96.74%
Dobesilate
Dexamethasone 96.05% 96.01% 95.90% 95.99%
Lidocaine HCl 95.69% 95.81% 95.10% 95.54%
Calcium
TR-145 96.89% 97.07% 98.82% 97.59%
Dobesilate
Dexamethasone 96.25% 96.34% 97.27% 96.62%
Lidocaine HCl 96.91% 96.23% 96.38% 96.51%
Calcium
TR-146 98.43% 98.34% 97.83% 98.20%
Dobesilate
Dexamethasone 97.71% 96.68% 96.92% 97.10%
17. Do you have product The firm has dedicated product development (R&D) section for
development (R&D) manufacturing of the product; however routine Quality Control
section? lab has been used for analysis purpose.
18. Do you have necessary The firm has necessary equipment available in product
equipment available in development section for development of Doxiproct Plus Ointment
product development however routine Quality Control has been used for analysis
section for development purpose.
of Doxiproct Plus
Ointment?
19. Are the equipment in The equipment in product development section are qualified.
product development
section qualified?
20. Do you have proper The firm has proper maintenance / calibration / re-qualification
maintenance / program for the equipment used in Product Development section.
calibration / re-
qualification program
for the equipment used
in PD section?
21. Do you have qualified The firm has three technical persons comprise of one Ph.D. and
staff in product two Pharm-Ds in manufacturing of New Products and three
development section Chemists and one Pharm-D working on analytical side.
with proper knowledge
and training in product
development?
22. Have you manufactured The firm has manufactured three stability batches for the stability
three stability batches studies (at 40°C/75%RH, 30°C/65%RH and 25°C/60%RH) of
for the stability studies Doxiproct Plus Ointment with batch number TR-144, TR-145 and
of Doxiproct Plus TR-146. Each batch has a size of 100 tubes of 10.0g.
Ointment?
23. What were the criteria The criteria for fixing the batch size of stability batches is the
for fixing the batch size number of tubes required per testing with number of testing
of stability batches? frequencies.
24. Do you have complete Batch manufacturing records for three (3) trial batches are
record of production of available.
stability batches?
25. Do you have protocols The firm has detailed protocols for stability testing of stability
for stability testing of batches.
stability batches?
26. Have you developed and The firm has developed and validated the method for testing of
validated the method for stability batches of finished product.
testing of stability
batches?
27. Do you have method Not applicable.
transfer studies in case
when the method of
testing being used by
your firm is given by
any other lab?
28. Do you have documents The firm has proper documents confirming the qualification of
confirming the equipment / instruments being used in the test and analysis of
qualification of Calcium Dobesilate, Lidocaine HCl and Dexamethasone Acetate
equipment / instruments APIs and the finished product Doxiproct Plus Ointment.
being used in the test
and analysis of Calcium
Dobesilate, Lidocaine
HCl and
APIs and the finished
drug?
29. Do your method of The firm’s method of analysis is stability indicating.
analysis stability
indicating?
30. Do your HPLC software HPLC software is 21CFR Compliant.
is 21CFR compliant?
31. Can you show Audit Audit trail on the testing reports are available.
Trail reports on Calcium
Dobesilate, Lidocaine
HCl and
testing?
32. Do you have some The firm has remaining quantities of stability batches for real time
remaining quantities of stability studies; however there is no quantity of degraded
degradation products andproducts.
stability batches?
33. Do you have The firm has three commitment batches kept on stability testing
commitment batches for real time stability testing up to 24 months.
kept on stability testing?
34. Do you have valid The firm has valid calibration status for the equipment used in
calibration status for the Doxiproct Plus Ointment (Calcium Dobesilate, Lidocaine HCl
equipment used in and Dexamethasone Acetate) production and analysis.
Doxiproct Plus
(Calcium Dobesilate,
Lidocaine HCl and
Dexamethasone
Acetate) Ointment
production in analysis?
35. Do proper and continuousThe firm has adequate monitoring and control system for stability
monitoring and controlchamber.
are available for stability
chamber?
36. Do related Firm has renovated their ointment / cream manufacturing section,
manufacturing area, however, this section still needs upgradation of HVAC system,
equipment, personnel creation of dispensing booth for dispensing dexamethasone.
and utilities be rated as Secondary change proper installation of ointment filling machine
GMP compliant? & utilities.
Conclusions:
On the basis of risk based approach the genuineness / authenticity of stability data submitted by the firm for
registration of Doxiproct Plus Ointment (Calcium Dobesilate 40mg/g, Lidocaine HCl 20mg/g and Dexamethasone
acetate 0.25mg/g) is verifiable to satisfactory level. However, the facilities related to ointment manufacturing area
cannot be rated as GMP compliant.
Decision of 276th meeting: Registration Board decided to defer the application for registration of “Doxiproct Plus
Ointment (Calcium Dobesilate 40mg/g, Lidocaine HCl 20mg/g and Dexamethasone acetate 0.25mg/g)” by M/s. AGP
Limited, Karachi in view of the fact that the facilities related to ointment manufacturing area cannot be rated as GMP
compliant.
Firm’s response: Firm has submitted GMP certificate no. 30/2021-DRAP (K) issue don basis of inspection conducted
on 03-06-2021,including Semisolid (Cream/Ointment) section.
Decision: Approved with Innovator’s specifications. The firm shall submit 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 07-05-2021,
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 as per the commitment submitted in the registration
application.
362. Name, address of Applicant / Marketing M/s MartinDow Limited, plot no. 37, Sector 19,
Authorization Holder Korangi Industrial area, Karachi.
Name, address of Manufacturing site. M/s MartinDow Limited, plot no. 37, Sector 19,
Korangi Industrial area, Karachi.
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. 671 dated 07/01/2022
The proposed proprietary name / brand name Empator-M XR Tablet 10mg + 1000mg
Strength / concentration of drug of Active Each film-coated tablet contains:
Pharmaceutical ingredient (API) per unit Empagliflozin (immediate release)……10mg
Metformin HCl (extended release)…..1000mg
Pharmaceutical form of applied drug Film coated, extended release tablet
Pharmacotherapeutic Group of (API) Antidiabetic
Proposed Pack size 14’s, 28’s
Proposed unit price AS per SRO
The status in reference regulatory authorities SYNJARDY XR Tablet 10mg/1000mg by
Boehringer Ingelheim, USFDA, UK & Health Canada
Approved.
For generic drugs (me-too status) Erli Plus Tablets 10mg + 1000mg by Pharmevo Reg.
No. 105274
GMP status of the Finished product manufacturer Copy of GMP certificate No. 85/2020-DRAP(K)
issued on the basis of inspection conducted on
07/05/2019
Section approval Table tgeneral section (Regularised)
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
solubility, physical form, manufacturers, description
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 substances (i.e Metformin &
Empagliflozin).
Empagliflozin:
Batches: EGLZ-20160501, EGLZ-20160502, EGLZ-
20160503
Metformin HCl:
Batches: 9002ML2RMI, 9003ML2RMI,
9004ML2RMI
validation studies, batch analysis and justification of
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence is established against the
dissolution profile Innovator product that is Synjardy XR Tablet 10mg +
1000mg by Boehringer Ingelheim, USA by
performing quality tests (Identification,
Disintegration, Assay, Dissolution, Uniformity of
dosage form).
is Synjardy XR Tablet 10mg + 1000mg by Boehringer
Ingelheim, USA 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 Analytical method verification / validation studies for
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-1614-S NPD-T-1623-S NPD-T-1624-S
No. of Batches 03
I Reference of previous approval of applications with Empator-M tablet 5mg+500mg (Empaglilozin +
stability study data of the firm (if any) Metformin HCl) approved in 312th meeting of
Registration Board.
II Approval of API/ DML/GMP certificate of API Empagliflozin:
manufacturer issued by concerned regulatory Copy of GMP Certificate for RUYUAN HEC Pharm
authority of country of origin. Co., Ltd. (Certificate: 2018024) issued by Shaoguan
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.
III Documents for the procurement of API with Empagliflozin: Firm has submitted copy of attested
approval from DRAP (in case of import). invoice (invoice# WIS200034) Dated: 16/04/2020 dy.
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.
IV Data of stability batches will be supported by Submitted

V Compliance Record of HPLC software 21CFR & Submitted

VI Record of Digital data logger for temperature and Record of digital data logger for temperature and
humidity monitoring of stability chambers (real humidity monitoring of stability chambers (real time
time and accelerated) and accelerated) is submitted.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Empator-M XR Tablet 5mg + 1000mg
Pharmaceutical ingredient (API) per unit Empagliflozin (immediate release)…….5mg
Metformin HCl (extended release)…..1000mg
The status in reference regulatory authorities SYNJARDY XR Tablet 5mg/1000mg by Boehringer
Ingelheim, USFDA, UK & Health Canada Approved.
For generic drugs (me-too status) Erli Plus Tablet 5mg + 1000mg by M/s Pharmevo
(Pvt.) Ltd., Reg. No. 105273
07/05/2019
Metformin HCl:
Empagliflozin).
Empagliflozin:
20160503
Metformin HCl:
9004ML2RMI
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence is established against the
dissolution profile Innovator product that is Synjardy XR Tablet 5mg +
1000mg by Boehringer Ingelheim, USA by
dosage form).
submitted.
Metformin HCl:
Maharahtra India.
Description of Pack
No. of Batches 03
Registration Board.
2021 is submitted.
Metformin HCl:
28/08/2018 valid till 27/08/2021.
No. 499 dated 04/05/2020.

☐ Importer
☐ Export sale
The proposed proprietary name / brand name Empator-M XR Tablet 12.5mg + 1000mg
Pharmaceutical ingredient (API) per unit Empagliflozin (immediate release)…….12.5mg
Metformin HCl (extended release)…….1000mg
The status in reference regulatory authorities SYNJARDY XR Tablet (5mg/1000mg,
10mg/1000mg, 12.5mg/1000mg, 25mg/1000mg)
USFDA Approved.
For generic drugs (me-too status) Erli Plus XR Tablet 12.5/1000mg by M/s Pharmevo
(Pvt.) Ltd., (Reg. No. 105275)
07/05/2019
Metformin HCl:
Empagliflozin).
Empagliflozin:
20160503
Metformin HCl:
9004ML2RMI
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence IS established against
dissolution profile the Innovator product that is Synjardy XR Tablet 5mg
+ 1000mg by Boehringer Ingelheim, USA by
dosage form).
submitted.
Metformin HCl:
Maharahtra India.
Description of Pack
No. of Batches 03
Registration Board.
2021 is submitted.
Metformin HCl:
28/08/2018 valid till 27/08/2021.
No. 499 dated 04/05/2020.

Remarks of Evaluator-I:
Sr. Observations Response
No.
1 The submitted stability data is till 3rd month The firm has referred to the earlier
time point, please provide stability study submitted stability data of 6th month time
data till 6th month time point. point for all three strengths.
2  Provide complete batch manufacturing Complete batch manufacturing record has
record for the applied product along with been submitted for three batches of each
the calculations for potency adjustment strength.
considering the assay value of the drug It is evident from the submitted batch
substance on As-is basis. processing record that instead of
dispensing the whole API coating solution
 Provide detail of manufacturing method in excess to overcome the process loss,
for the applied product. firm has used 100% excess of
Empagliflozin only.
Justification of Overage:
Empator-M 25mg + 1000mg XR Tablet was developed with reference to the Innovator product, Synjardy 25mg +
1000mg XR Tablet of MSD, which contains extended-release core of Metformin HCl (1st API) and API coating of
immediate release Empagliflozin (2nd API).
The coating process itself, is inevitable to process loss, due to which it is required to add an excess amount of raw
materials in the coating solution so that the final landing quantity of API on the core tablet complies with the claimed
amount.
Similar case was observed at development stage, during the coating of Empagliflozin on Metformin core, the quantity
of coating solution was gradually increased by hit n trial to comply the landing quantity of API on the tablet in
accordance with the label claim.
With reference to the WHO Annex 3 Pharmaceutical development of multisource (generic) finished pharmaceutical
products, the excess quantity of API coating solution is justified as the excess is lost during the coating process and it
was completely utilized to achieve the required quantity on the tablet after Drug loading stage.
The assay results of API Empagliflozin at release testing and throughout the stability studies, are within the label
claimed amount, making it evident that the excess amount of API coating solution was lost during the coating process
and was not part of the finished dosage form. The Assay results of the stability studies are given as reference:
Justification of dissolution profile:

Martin Dow Limited has developed following strengths of Empagliflozin + Metformin HCl XR tablets for new
product registration applications,
Empagliflozin 5 mg + Metformin HCl 1000 mg XR Tablet
Empagliflozin 12.5 mg + Metformin HCl 1000 mg XR Tablet
As per the ICH Q 1 D guideline of Bracketing and Matrixing designs for Stability Testing of Drug Substances and
Drug Products
Bracketing can be applied to studies with multiple strengths of identical or closely related formulations. Examples
include but are not limited to (1) capsules of different strengths made with different fill plug sizes from the same
powder blend, (2) tablets of different strengths manufactured by compressing varying amounts of the same
granulation, and (3) oral solutions of different strengths with formulations that differ only in minor excipients (e.g.,
colourants, flavourings).
Martin Dow has perfomed Extended-release dissolution profile at core stage before coating of Empator 12.5/1000mg
XR and Empator 5/1000mg XR Tablet tablet, meanwhile establishing dissolution profile of Empator 25/1000mg XR
Tablet of core stage as per the method of bracketing, and later on batches were found to have the satisfactory results
with extended release dissolution profile of Metformin HCl specification at coated stage.
Decision of 326th meeting: Registration board deferred the applications of Empator-M XR Tablet 10mg + 1000mg,
Empator-M XR Tablet 5mg + 1000mg & Empator-M XR Tablet 12.5mg + 1000mg for following reasons:
 Scientific justification on the basis of performance based data for using 100% excess of drug substance in the
active coating of Empagliflozin.
 Submission of any performance based data to justify that 100% excessive Empagliflozin is required to
overcome the process loss during active coating.
 Justification for referring the “ICH Q 1 D guideline of Bracketing and Matrixing designs for Stability Testing
of Drug Substances and Drug Products” for skipping the in-process test of dissolution of Metformin extended
release core, since the cited guideline is intended to address recommendations on the application of bracketing
and matrixing to stability studies.
365. Name, address of Applicant / Marketing M/s Martin Dow Limited, plot no. 37, Sector 19, Korangi
Authorization Holder Industrial area, Karachi.
Name, address of Manufacturing site. M/s MartinDow Limited, plot no. 37, Sector 19, Korangi
Industrial area, Karachi.
☐ Importer
☐ Export sale
Empator-M XR Tablet 25mg+1000mg
name
Strength / concentration of drug of Active Each film coated, extended release tablet contains:
Pharmaceutical ingredient (API) per unit Empagliflozin (immediate release)……..25mg
Metformin HCL (extended release)…….1000mg
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) issued on
manufacturer the basis of inspection conducted on 07/05/2019
RUYUAN HEC Pharm Co., Ltd. Xiaba Development Zone,
Ruyuan County, Shaoguan City, Guangdong Province, P.R.
China
Metformin HCl:
Summarized information related to nomenclature, structure,
and its verification, batch analysis and justification of
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 manufacturing
process and controls, impurities, residual solvents,
specifications, analytical procedures and its complete
specification, details of reference standards, container
closure system and stability studies of drug substances (i.e
Metformin & Empagliflozin).
Empagliflozin:
20160503
Metformin HCl:
Batches: 9002ML2RMI, 9003ML2RMI, 9004ML2RMI
Module-III (Drug Product): The firm has submitted detail of manufacturers, description
studies, batch analysis and justification of specification,
studies of drug product.
Pharmaceutical equivalence and comparative Pharmaceutical equivalence studies have been submitted
dissolution profile 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 validation/verification of Analytical method verification / validation studies for drug
product substance as well as for drug product is submitted.
RUYUAN HEC Pharm Co., Ltd. Xiaba Development Zone, Ruyuan County,
Shaoguan City, Guangdong Province, P.R. China
Metformin HCl:
Maharahtra India.
Description of Pack
Batch Size 4000 tablet 4000 tablet 4000 tablet
Manufacturing Date 07/07/2021 04/08/2021 07/07/2021
Date of Initiation 17/08/2021 17/08/2021 17/08/2021
No. of Batches 03
1. Reference of previous approval of Empator-M tablet 5mg+500mg (Empaglilozin + Metformin
applications with stability study data of the HCl) approved in 312th meeting of Registration Board.
firm (if any)
2. Approval of API/ DML/GMP certificate of Empagliflozin:
API manufacturer issued by concerned Copy of GMP Certificate for RUYUAN HEC Pharm Co.,
regulatory authority of country of origin. Ltd. (Certificate: 2018024) issued by Shaoguan Food and
Drug Administration & valid upto 04-12-2021 is submitted.
Metformin HCl:
GMP/Cert/AD/67318/2018/11/24741 issued on 28/08/2018
valid till 27/08/2021.
3. Documents for the procurement of API with Empagliflozin: Firm has submitted copy of attested invoice
approval from DRAP (in case of import). (invoice# WIS200034) Dated: 16/04/2020 dy. No. 499 dated
04/05/2020.
MEG2122/1630115 dated 02/04/2021 (diary No. 4247 dated
07/04/2021) imported from IPCA Laboratories limited
attested by DRAP Karachi.
summary data sheets etc.
5. Compliance Record of HPLC software Submitted
testing
6. Record of Digital data logger for temperature Record of digital data logger for temperature and humidity
and humidity monitoring of stability monitoring of stability chambers (real time and accelerated)
chambers (real time and accelerated) is submitted.
Remarks of Evaluator-I:
Sr. Observations Response
No.
1 The submitted stability data is till 3rd month The firm has submitted stability summary sheets
time point, please provide stability study till 6 months for accelerated and long term
data till 6th month time point. stability studies along with the relevant
documents.
2 As per submitted dossier, titration method “The method used for assay estimation of
has been used for assay estimation for Metformin for finished product by FPP
Metformin HCl while according to latest manufacturer is HPLC as per latest edition of
edition of USP, HPLC method should be USP. API manufacturer has used titration
used for assay testing, please clarify. method for assay estimation owing to the
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 tests The Dissolution testing for Metformin HCl was
for Metformin core before coating has not performed at core stage before coating and
been performed. Clarification is required for results were well within specified limits. Since
not establishing the dissolution profile for Metformin HCl in all strength have same label
the tablet core. 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 for The firm has submitted complete batch
the applied product. manufacturing record for the applied product.
6. Scientific justification is required 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 of 322nd meeting: 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.
Firm’s response:
Justification of Overage:
Empator-M 25mg + 1000mg XR Tablet was developed with reference to the Innovator product, Synjardy 25mg +
1000mg XR Tablet of MSD, which contains extended-release core of Metformin HCl (1st API) and API coating of
immediate release Empagliflozin (2nd API).
The coating process itself, is inevitable to process loss, due to which it is required to add an excess amount of raw
materials in the coating solution so that the final landing quantity of API on the core tablet complies with the claimed
amount.
Similar case was observed at development stage, during the coating of Empagliflozin on Metformin core, the quantity
of coating solution was gradually increased by hit n trial to comply the landing quantity of API on the tablet in
accordance with the label claim.
With reference to the WHO Annex 3 Pharmaceutical development of multisource (generic) finished pharmaceutical
products, the excess quantity of API coating solution is justified as the excess is lost during the coating process and it
was completely utilized to achieve the required quantity on the tablet after Drug loading stage.
The assay results of API Empagliflozin at release testing and throughout the stability studies, are within the label
claimed amount, making it evident that the excess amount of API coating solution was lost during the coating process
and was not part of the finished dosage form. The Assay results of the stability studies are given below as reference:
Batch No. NPD-T-1616-S

Real Time
Assay
0 3M 6M
(Empagliflozin)
90.0 %-110.0 % 101.5 % 101.7 % 97.8 %
Accelerated
90.0 %-110.0 % 101.5 % 101.9 % 98 %
Justification of dissolution profile:

Martin Dow Limited has developed following strengths of Empagliflozin + Metformin HCl XR tablets for new
product registration applications,
Empagliflozin 12.5 mg + Metformin HCl 1000 mg XR Tablet
As per the ICH Q 1 D guideline of Bracketing and Matrixing designs for Stability Testing of Drug Substances and
Drug Products
Bracketing can be applied to studies with multiple strengths of identical or closely related formulations. Examples
include but are not limited to (1) capsules of different strengths made with different fill plug sizes from the same
powder blend, (2) tablets of different strengths manufactured by compressing varying amounts of the same
granulation, and (3) oral solutions of different strengths with formulations that differ only in minor excipients (e.g.,
colourants, flavourings).
Martin Dow has perfomed Extended-release dissolution profile at core stage before coating of Empator 12.5/1000mg
XR and Empator 5/1000mg XR Tablet tablet, meanwhile establishing dissolution profile of Empator 25/1000mg XR
Tablet of core stage as per the method of bracketing, and later on batches were found to have the satisfactory results
with extended release dissolution profile of Metformin HCl specification at coated stage.
Decision of 326th meeting: Registration board deferred the application for following reasons:
 Scientific justification on the basis of performance based data for using 100% excess of drug substance in the
active coating of Empgaliflozin.
 Justification for referring the “ICH Q 1 D guideline of Bracketing and Matrixing designs for Stability Testing
release core, since the cited guideline is intended to address recommendations on the application of bracketing
and matrixing to stability studies.
Firm’s reply:
Sr.# Observations
1.  Scientific justification on the basis of performance based data for using 100% excess of drug substance
in the active coating of Empagliflozin.
Firm’s response:
 The excess quantity in the coating solution was achieved on hit and trial basis.
 Tablet coating is a process of applying a layer of polymer on rotating tablet in a coating pan which is
highly susceptible to loss due to atomization, solvent evaporation, removal by exhaust system and
accumulation on the surface of coating pan. So, the coating suspension/solution is generally prepared in
excess to overcome these losses and achieve the desired amount of coating.
 To decide the percentage of film coating for Empator-M XR tablet range, various patents and coating applications
were studied. As mentioned in Aulton’s Pharmaceutics – the design and manufacture of medicines Third
Edition (p#502), coatings are up to 2-3% normally, but can deviate as per requirements.
 Keeping the above in view, a theoretical weight of each coating layer and the final coated tablet was determined
to load a specific quantity of coating material and achieve the claimed amount of API-Empagliflozin on each tablet.
1st Trial batch:
The initial trial formulation was developed according to the excipients used by the Innovator and the coating suspension
was prepared with 50% excess considering the losses during coating operation as described above.
Batch no. Excess quantity (%) Remarks
50% (initial) Before achieving target theoretical weight, the coating
NPD-T-1135-T (B) suspension got finished. Hence, same quantity of materials
50% (re-dispensed) was dispensed again, and suspension was prepared to
complete coating.
Total 100%
The BPR of the above-mentioned batch is provided, which shows that during coating process the coating suspension
was fully consumed, however, the theoretical weight of the tablet was not achieved. Hence, the coating suspension was
dispensed again, coating was continued, and the desired theoretical weight was achieved.
2nd Trial batch:
The second trial was manufactured and, from the experience learned from 1st trial, the initial quantity of coating material
was dispensed with only 75% excess to try to reduce the extra material, avoid the need for re-dispensing and achieve
the desired theoretical weight in one-go.
Batch no. Excess quantity % Remarks
75% (initial) Before achieving target weight, coating suspension was
NPD-T-1135-T (D) finished. Hence, same quantity of materials was dispensed
75% (re-dispensed)
again, and suspension was prepared to complete coating.
Total 150%
However, as mentioned in its provided BPR, the coating suspension was without reaching the desired theoretical weight.
Hence, the coating suspension was dispensed again, coating was continued, and the desired theoretical weight was
achieved while some of the coating suspension was left.
3rd Trial batch:
A third trial was manufactured and, from the experience learned from 1st and 2nd trials, the initial quantity of coating
material was dispensed with only 85% excess to again try to reduce the extra material, avoid the need for re-dispensing
and achieve the desired theoretical weight in one-go.
85% (initial) Before achieving target weight, coating suspension was
NPD-T-1135-T (E) finished. Hence, same quantity of materials was dispensed
85% (Re-dispensed) again, and suspension was prepared to complete coating.
Total 170%
However, as mentioned in its provided BPR, the coating suspension was fully consumed without reaching the desired
theoretical weight. Hence, the coating suspension was dispensed again, coating was continued, and the desired
theoretical weight was achieved while some of the coating suspension was left.
4th Trial batch:
As per the experiences gained from previous trials, another trial batch was manufactured with 100% excess in coating
suspension.
NPD-T-1382-T (C) 100% Target weight was achieved without the need of re-dispensing
NPD-T-1426-T (A) 100% Target weight was achieved without the need of re-dispensing
NPD-T-1456-T (M) 100% Target weight was achieved without the need of re-dispensing.
 The samples were tested with satisfactory results. The BPRs are provided. Report of satisfactory trial (1456 M) is
also provided as same formulation and process controls were carried to stability batches.
 The final weight of tablets and utilization of coating suspension was monitored closely during development in order
to reduce the excess as much as possible. And, in light of the development data obtained from the manufacturing
and analysis of all the above-mentioned batches, the final formulation was fixed with 100% excess.
 Any excess quantity is lost during the coating process and final landing quantity of API on the tablets remains well
within the specified limits and claimed amount, evident from the analytical reports, and thus, will not reach the
patients. As patient safety & efficacy is MDL’s prime concern.
 Moreover, from the knowledge and experience of commercial manufacturing, it can be expected that as the batch
size and machine capacity will increase, the percentage of excess quantity that will be required to coat a commercial
batch will reduce.
2. Justification for referring the “ICH Q 1 D guideline of Bracketing and Matrixing designs for Stability Testing
release core, since the cited guideline is intended to address recommendations on the application of
bracketing and matrixing to stability studies.
Firm’s response:
The Dissolution Profile on Metformin HCl extended release core tablets is performed on initial trail batches.
The spcecification of product is adopted on the basis of FDA Dissolution Methods Database, Center of Drug
Evaluation Application No. 208658Orig1s000” Chemistry Review & USP monograph Specifiaction of
Metformin HCl extended release tablet.
The methdology adopted was based on the refrences of Metformin HCl core tablet which has following stages:
First stage:
In first stage of product devleopment, Metformin HCl extended release tablet at Core Stage was developed and assesed
as mentioned in table below. All tablets in the Empagliflozin + Metformin HCl XR tablet range have the exact same core
of Metformin HCL 1000mg.
Specification Dissolution
S.No Product Name Batch Dissolution on core
(Metformin HCl) Performed
(NMT 22 - 42% in 2
Empagliflozin +
NPD-T-1108- hours)
01 Metformin HCl XR ✓
T (NMT 49 - 69% in 4
Tablet 5 + 1000 mg
hours)
(Not less than 85%
(Q=80%) in 12 hours)
(NMT 22 - 42% in 2
Empagliflozin + hours)
Metformin HCl XR NPD-T-1107- (NMT 49 - 69% in 4
02 ✓
Tablet 12.5 + 1000 T hours)
mg (Not less than 85%
(Q=80%) in 12 hours)
As the core of Metformin HCl is exactly same in all 4 strengths of this range, and considering the satisfactory results of
Dissolution testing of core tablet in 1st stage, the Comparative Dissolution Profile on the final coated tablet was performed
on all strengths in comparison with the Innovator Product “Synjardy XR Tablet” of Boehrenger Ingelheim (as given in
the table below) and comparable results were acheived. Satisfactory stability reslults of all strengths are well within
specified limits.
Comparitive
Innovator
S.No Product Name Batch Dissolution
Batch
Profile
Empagliflozin + NPD-T-1656-S* Yes 3191437
01 Metformin HCl XR Tablet NPD-T-1660-S - -
5 + 1000 mg NPD-T-1661-S - -
10 + 1000 mg NPD-T-1624-S - -
12.5 + 1000 mg NPD-T-1626-S - -
25 + 1000 mg NPD-T-1617S - -
*Representative stability batch
To establish the analytical target profile (ATP) of products the knowledge, experience and referance research
publication play an important role in setting method specification on identified CQA (Critical Quality
Attributes). All tests are bieng perfomed to assure the product quality attributes. The use of ICH Q1D is just
to understand the scope of ICH Q14. Section 4. “Knowledge and risk management in Anlytical
Procedure Development and Continual Improvement”
All future and commercial batches will be tested for dissolution and assay at core stage also as per
compliance with quality guidelines.
Decision: Registration Board approved the applications of Empator-M XR Tablet 10mg + 1000mg, Empator-
M XR Tablet 5mg + 1000mg, Empator-M XR Tablet 12.5mg + 1000mg & Empator-M XR Tablet
25mg+1000mg. Registrationletter will be issued upon submission of protocol for in-process testing including
dissolution test to establish dissolution profile of metofmrin HCl at core stage.
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.
c. Deferred cases of Form 5.
366. Name and address of M/s Maxitech Pharma Pvt Ltd. Plot No. E-178, S.I.T.E. Super
manufacturer / Applicant Highway, Phase II, Karachi
Brand Name + Dosage Form + Fertrex N Cream 0.025%/0.5%
Strength
Composition Each Gm Cream Contains:
Fluocinolone Acetonide 0.25mg
Neomycin Sulphate 5mg
Diary No. Date of R& I & fee Form-5 Dy.No 13558 dated 07-03-2019 Rs.20,000/- dated 06-03-
2019
Pharmacological Group Corticosteroid
Type of Form Form-5
Finished product Specifications USP Specification
Pack size & Demanded Price As per SRO
Approval status of product in Could not be confirmed
Reference Regulatory Authorities
Me-too status (with strength and 029329; "BREVOXYL 4% Cream"
dosage form) "GSK"
GMP status GMP certificate issued on 31.08.2022
Remarks of Evaluator II:
Decision of 327th meeting: Deferred for evidence of approval of applied formulation in reference
regulatory authorities / agencies which were adopted by the Registration Board in its 275 th meeting.
Firm’s response: Firm has referred to the US FDA product “Neo-Synalar cream” for the applied
formulation.
Decision: Approved.
Brand Name + Dosage Form + Bitrex 4% Cream
Strength
Composition Each 100Gm Cream Contains:
Benzoyl Peroxide….. 4g
Diary No. Date of R& I & fee Form-5 Dy.No 13565 dated 07-03-2019 Rs.20,000 dated 06-03-
2019
Pharmacological Group organic compounds
Type of Form Form-5
Finished product Specifications Maxitech Specification
Me-too status (with strength and 019464; "BREVOXYL 4% Cream"
dosage form) "GSK"
II
Remarks of Evaluator :
Decision of 327th meeting: Deferred for evidence of approval of applied formulation in reference
regulatory authorities / agencies which were adopted by the Registration Board in its 275 th meeting.
Firm’s response: Firm has referred to the Brevoxyl 4% cream approved by MHRA of UK.
Decision: Approved with BP specfications. The firm shall submit 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 07-
05-2021, before issuance of registration letter.
Brand Name + Dosage Form + Fetrex Topical Solution 0.01%
Strength
Composition Each ml Contains:
Fluocinolone Acetonide……. 0.1mg
2019
Pharmacological Group Corticosteroid
Type of Form Form-5
Me-too status (with strength and Could not be confirmed
dosage form)
 Evidence of applied formulation/drug already approved by DRAP (generic / me-too status) alongwith
registration number, brand name and name of firm.
 Evidence of approval of applied formulation in reference regulatory authorities/agencies which were
adopted by the Registration Board in its 275th meeting.
Firm’s response: Firm has referred to following products:
 Synalar Topical solution 0.01% approved by US FDA.
 Flucinate Topical Oil 0.01% of M/s Atco (Reg.#92728)
Decision: Approved.
Brand Name + Dosage Form + D-Light 50000 soft Gelatin Capsule
Strength
Composition Each Soft Gelatin Capsule Contains:
Vitamin D3 50000IU
2019
Pharmacological Group Vitamin
Type of Form Form-5
Approval status of product in Altavita D3 50000 iu soft capsules
Reference Regulatory Authorities HPRA
Me-too status (with strength and 097598; "HUESO-D 50000IU SOFT GELATIN CAPSULE"
dosage form) "VALOR/AL-HAMEED"
 Decision of 327th meeting: Deferred for confirmation of required manufacturing facility / section from
Licensing Division.
Firm’s response: Firm has copy of letter no. F.2-12/2012-Lic dated 25-11-2016 for issuance of DML
including Soft gelatin capsule section.
Decision: Approved.
Brand Name + Dosage Form + Clospo 25mg Soft Gelatin Capsule
Strength
Composition Each Soft Gelatin Capsule Contains:
Cyclosporin …… 25mg
2019
Pharmacological Group Immunosuppressant
Type of Form Form-5
Approval status of product in Sandimmune® Soft Gelatin Capsule
Reference Regulatory Authorities USFDA Approved.
Me-too status (with strength and Sandimum soft Gelatin Capsules
dosage form) NOVARTIS
Decision of 327th meeting: Deferred for confirmation of required manufacturing facility / section from
Licensing Division.
Firm’s response: Firm has copy of letter no. F.2-12/2012-Lic dated 25-11-2016 for issuance of DML
including Soft gelatin capsule section.
Decision: Approved.
371. Name and address of M/s MTI Medical Pvt Ltd. 586-587, Sundar Industrial Estate,
manufacturer / Applicant Lahore, Pakistan"
Brand Name +Dosage Form + Colimate Lyophilized 200,0000 IU Injection
Strength
Composition "Each Vial Contains:
Colistimethate Sodium…200,0000 IU"
Diary No. Date of R& I & fee Dy. No 2686 dated 21-01-2019, Rs.20,000/- Dated 16-01-2019
Pharmacological Group Antibiotic
Type of Form Form-5
Finished product Specifications USP Specifications
Pack size & Demanded Price 1’s: As per SRO
Approval status of product in Approved in MHRA
Reference Regulatory
Authorities
Me-too status (with strength and Could not be confirmed
dosage form)
GMP status New Section (Letter Issuance date: 11th April, 2017)
Lyophilized Vials Injectable (general)
Remarks of the EvaluatorII
Previous Decision of 289th meeting: Deferred for submission of stability studies both accelerated &
real time for six months as per guidelines approved & reviewed by registration board in its 251 st & 278th
meeting respectively.
Firm’s response: Firm has submitted request for withdrawal of Form 5-D application of Colimate
2MIU applied on Form 5.
Decision: Registration Board accede with the request of the firm and declared the application as
disposed of.
Agenda of Evaluator PEC-III
Case No. 01 Registration applications of CTD cases
a. Cases of Export Facilitation
M/s Welmark Pharmaceuticals

Depauty Director PRV/EFD vide its letter dated 2 nd June 2023 informed that in pursuance of decision of
133rd meeting of the Authority wherein it was decided that for each 100,000 USD worth of export during
a fiscal year one molecule will be considered on priority basis. In compliance to this, M/s Welmark
Pharmaceuticals, Hattar has achieved the benchmark of more than 100,000 USD during the financial year
2022-2023. Accordingly, the firm has requested for priority consideration of the following molecule
371. Name, address of Applicant / Marketing M/s Welmark Pharmaceuticals, Plot No. 122,
Authorization Holder Block B, Phase V, Industrial Estate Hattar
District Haripur.
Name, address of Manufacturing site. M/s Weather Folds Pharmaceuticals Plot No.
69/2, Block B, Industrial Estate, Hattar, Haripur.
☐ Importer
☒ Is involved in none of the above (contract
giver)
GMP status of the firm The firm has submitted copy of GMP certificate
of M/s Weather Folds Pharmaceuticals, Hattar
issued on the basis of inspection dated 12-10-
2022.
The firm has submitted copy of GMP certificate
of M/s Welmark Pharmaceuticals, Hattar issued
on the basis of inspection dated 11-11-2021.
Evidence of approval of manufacturing facility The firm has submitted copy of GMP certificate
of M/s Weather Folds Pharmaceuticals, Hattar
2022. The certificate specifies Dry powder
injection (Cephalosporin) section.
☐ Export sale
The proposed proprietary name / brand name CEFZECT 2.5gm Injection
Pharmaceutical ingredient (API) per unit Ceftazidime (as pentahydrate)………2000mg
Avibactam (as sodium salt)………500mg
Pharmaceutical form of applied drug White to off white color sterile powder for
injection filled in glass vials.
Pharmacotherapeutic Group of (API) Cephlosporin
The status in reference regulatory authorities (USFDA Approved)
For generic drugs (me-too status) Zavicefta Injection by Pfizer (Reg No. 106848)
Name and address of API manufacturer. Zhuhai United Laboratories Co. Ltd. No. 2428,
Anji Road, Sanzao Town, Jinwan District, Zhuhai
Guangdong China.
template. Firm has summarized information
analytical procedures and its validation, batch
analysis and justification of specification,
stability studies of drug substance and drug
product.
Module-III Drug Substance: Firm has submitted detailed data for drug
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 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 6
months.
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
standard or materials, container closure system
and stability.
Dissolution Profile equivalence for the quality tests for their product
against Zavicefta Injection.
Analytical method validation/verification of Firm has submitted verification studies of the drug
product substance and analytical method validation of the
drug product.
Manufacturer of API Zhuhai United Laboratories Co. Ltd. No. 2428, Anji Road, Sanzao Town,
Jinwan District, Zhuhai Guangdong China.
API Lot No. 202112001
Description of Pack
Glass vials
Batch No. T-01 T-02 T-03
No. of Batches 03
1. Reference of previous approval of applications Firm has referred to their previous PSI inspection
with stability study data of the firm (if any) conducted for the product SACUVAL Tablet
conducted on 01-09-2020 which was considered
by Registration Board in its 296th meeting.
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP certificate (No.
manufacturer issued by concerned regulatory GD20180909) issued by CFDA China. The
authority of country of origin. certificate is valid till 05-12-2023.
3. Documents for the procurement of API with Firm has submitted copy of Goods Declaration
approval from DRAP (in case of import). (GD) dated 16-05-2022 which mention 2Kg
ceftazidime avibactam Batch No. 202112001.
4. Data of stability batches will be supported by Firm has submitted complete record of testing of
attested respective documents like all batches along with raw data sheets, COA and
chromatograms, Raw data sheets, COA, summary data sheets.
5. Compliance Record of HPLC software 21CFR & Firm has submitted HPLC audit trail reports
Evaluation by PEC:
Sr. No Observations communicated Response by the firm

1. Specify the details of applicant firm in section 1.3.1, Written mistakenly revised and
since you have mentioned M/s weather folds correct resubmitted
pharmaceuticals as applicant, while the fee challan
specifies that the applicant is M/s Welmark
Pharmaceuticals.
2. Submit data in section 3.2.S.4.1 and 3.2.S.4.2 as per Copies of the drug substance
the guidance document approved by Registration specifications and analytical
Board which specifies that “Copies of the Drug procedures used for routine testing of
substance specifications and analytical procedures Drug substance /Active
used for routine testing of the Drug substance Pharmaceutical Ingredient by both
/Active Pharmaceutical Ingredient by both Drug Drug substance and Drug Product
substance & Drug Product manufacturer is required.” manufacturer is submitted.
3. The specifications of API submitted in section In S part data taken from DMF while
3.2.S.4.1 specifies that acceptance criteria for received COA along with API shows
ceftazidime is NMT 68.5%, while the acceptance limits range.
criteria for ceftazidime mentioned in API of batch
202112001 is 68.5% - 75%. Clarify how the
specifications are different.
4. Submit verification studies of the drug substance Verification studies of the drug
performed by drug product manufacturer, since you substance performed by drug product
have only submitted a singke table for the results manufacturer is submitted.
without any protocols and detailed results of each
test of verification studies.
5. The COA of API manufacturer specifies that the We consider API as finish product
acceptance criteria for ceftazidime is 68.5% - 75% that’s why we give limits of finish
and avibactam is 17.1% to 18.9%, while your own product.
COA for the same batch specifies that the acceptance
criteria for ceftazidime and avibactam is 90% -
110%. Clarify how the drug product manufacturer
can have different acceptance criteria.
6. Submit COA of reference standard actually used in Submitted by the firm.
the analysis of drug substance and drug product.
7. Submit stability study data of drug substance till Firm has submitted stability study
claimed shelf life, since you have only submitted data of drg substance till 24 months
stability data for 6 months.
8. Specify the diluent along with its exact quantity Water for injection
which will be supplied with this product.
9. Submit image/picture/snapshot claearly indicating Submitted by the firm
batch number and expiry date of the reference
product against which pharmaceutical equivalence
studies have been conducted, since the submitted
pictures do not show these details.
10. Submit microbiological properties in section Submitted by the firm
3.2.P.2.5 as per ICH requirement, since the
submitted description doe not provide the required
information.
11. Submit compatibility studies of the apllied product Already performed by innovators
with the recommended diluent in section 3.2.P.2.6.
12. Justify why sodium content test is not included in the No sodium content test performed by
drug product specifications. innovator and API Manufacturer.
13. Submit complete method of analysis of the drug Submitted by the firm
product, since the submitted method is incomplete
and not properly printed.
14. Submit complete report of validation studies of the Submitted by the firm
drug product, since you have only submitted a
singke table for the results without any protocols and
detailed results of each test of verification studies.
15. Your batch size is 200 vials and your own Mistakenly written revised and
calculation specifies that total vials required to carry correct data sheet resubmitted.
out all physical and chemical tests during stability
studies are 216 vials and that you have 360
injections as retained samples. Clarification is
required in this regard.
16. Submit stability study data in section 3.2.P.8.3 as per Submitted by the firm
the 6 points checklist as mentioned in the CTD
guidance document, since you have randomly
submitted the data without following the
recommendations of guidance document.
17. Submit stability study data in section 3.2.P.8.3 as per Submitted by the firm
the checklist approved by Registration Board in its
293rd meeting, which includes the following
documents:
o Reference of previous approval of applications
o Approval of API/ DML/GMP certificate of API
o Documents for the procurement of API with
o Data of stability batches will be supported by
o Compliance Record of HPLC software 21CFR &
o Record of Digital data logger for temperature
18. You have manufactured three batches while the BMR Capacity of vial filling machine 1000
indicates that the filling of all the three batches was per hour same container filled
carried out on 16-08-2022 at the same time during continuously.
2.00 to 3.00 PM. Clarification is required how three
batches can be filled at a time.
Decision: Approved with Innovator’s specifications.
 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.
b. New cases of local manufacturing
372. Name, address of Applicant / Marketing M/s Getz Pharma (Pvt) Ltd, Plot No 29-30,
Authorization Holder Sector 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
☐ Is involved in none of the above (contract
giver)
2022.
Evidence of approval of manufacturing facility Firm has submitted copy of letter of renewal of
DML dated 30-10-2019 which specifies Tablet
section (General).
☐ Export sale
The proposed proprietary name / brand name ROXAGET Tablet 20mg
Strength / concentration of drug of Active Each film coated tablet Contains:
Pharmaceutical ingredient (API) per unit Roxadustat………20mg
Pharmaceutical form of applied drug Blue colored oblong shaped film coated tablet
Pharmacotherapeutic Group of (API) Other antianemic preparations
Clinical Indication Evrenzo is indicated for treatment of adult
patients with symptomatic anaemia associated
with chronic kidney disease (CKD).
Proposed unit price 7000/-
The status in reference regulatory authorities Evrenzo Tablet (MHRA Approved)
Name and address of API manufacturer. Shanghai Pharma Group Changzhou Kony
Pharmaceutical Co., Ltd. Daixi Street, Luoyang
Town, Wujin District, Changzhou Jiangsu China
product.
months.
and stability.
against Evrenzo tablet 20mg manufactured by M/s
Astellas Pharma Ltd.
Firm has submitted results of CDP for their
product against Evrenzo tablet 20mg
manufactured by M/s Astellas Pharma Ltd in 3
dissolution medium.
product substance and the drug product.
Manufacturer of API Shanghai Pharma Group Changzhou Kony Pharmaceutical Co., Ltd. Daixi
Street, Luoyang Town, Wujin District, Changzhou Jiangsu China
API Lot No. RST20210704
Description of Pack
Alu-PVC blister
Batch No. 635DS01 635DS02
Batch Size 5000 Tablet 5000 Tablet
Date of Initiation 25-08-2022 25-08-2022
No. of Batches 03
1. Reference of previous approval of applications Firm has referred to their last product specific
with stability study data of the firm (if any) inspection conducted for “Emclide 10mg & 25mg
Tablet”, which was conducted on 2nd December,
2021, and was presented in 316th meeting of
Registration Board.
The 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.
manufacturer issued by concerned regulatory JS20180935) issued by CFDA China. The
3. Documents for the procurement of API with Firm has submitted copy of Form 6, License to
approval from DRAP (in case of import). import drugs for clinical trials, examination, test of
analysis dated 06-04-2022.
4. Data of stability batches will be supported by Firm has submitted record of testing of all batches
attested respective documents like along with raw data sheets, COA and summary
chromatograms, Raw data sheets, COA, data sheets.
5. Compliance Record of HPLC software 21CFR & Firm has submitted audit trail reports
3
Evaluation by PEC :
Sr. No Shortcomings communicated Response by the firm

1. Specify the exact polymorphic form of the
drug substance used in the development of
this product.
2. Submit real time stability study data of drug
substance till claimed shelf life, since the
submitted data is till 18 months.
3. Submit evidence of import of drug substance
since you have only submitted Form 6,
License to import which does not confirm
that the drug substance has been imported or
not.
Decision: Registration Board deferred the case for submission of reply to the above cited
shortcomings and evaluation by PE&R Division.
☐ Importer
giver)
2022.
section (General).
☐ Export sale
product.
months.
and stability.
dissolution medium.
Description of Pack
Alu-PVC blister
Batch No. 636DS01 636DS02
Batch Size 5000 Tablet 5000 Tablet
Date of Initiation 25-08-2022 25-08-2022
No. of Batches 03
Registration Board.
Evaluation by PEC3:

this product.
not.
☐ Importer
giver)
2022.
section (General).
☐ Export sale
product.
months.
and stability.
against Evrenzo tablet 100mg manufactured by
M/s Astellas Pharma Ltd.
dissolution medium.
Description of Pack
Alu-PVC blister
Batch No. 634DS01 634DS02 634DS03
No. of Batches 03
Registration Board.
3
Evaluation by PEC :

this product.
not.
375. Name, address of Applicant / Marketing M/s Horizon Healthcare (Pvt) Ltd. Plot No. 33,
Authorization Holder Sundar Industrial Estate, Lahore.
Name, address of Manufacturing site. M/s Horizon Healthcare (Pvt) Ltd. Plot No. 33,
Sundar Industrial Estate, Lahore.
☐ Importer
giver)
2021.
section (General).
☐ Export sale
The proposed proprietary name / brand name ROXATA Tablet 20mg
Pharmaceutical form of applied drug Red colored oval shaped film coated tablet
Name and address of API manufacturer. Dr. Reddy’s Laboratories Limited Chemical
Technical operations Unit-VI, APIIC Industrial
Estate, Pydibhimavaram village, Ranasthalam
Mandal, Srikakulam District 532409, Andhra
Pradesh, India.
product.
months.
and stability.
dissolution medium.
Manufacturer of API Dr. Reddy’s Laboratories Limited Chemical Technical operations Unit-VI,
APIIC Industrial Estate, Pydibhimavaram village, Ranasthalam Mandal,
Srikakulam District 532409, Andhra Pradesh, India.
API Lot No. AFPH007658
Description of Pack
Alu-Alu blister
Batch No. RLD-001 RLD-002 RLD-003
No. of Batches 03
with stability study data of the firm (if any) inspection conducted for “Empazon 10mg & 25mg
Tablet”, which was conducted on 1st June, 2021,
and was presented in 307th meeting of Registration
Board.
 The HPLC software is 21CFR Compliant.
 Firm has demonstrated Audit trail reports of
testing.
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP certificate issued
manufacturer issued by concerned regulatory by Drugs Control Administration Government of
authority of country of origin. Andhra Pradesh dated 18-02-2022. The certificate
was valid till 1 year.
Firm has submitted copy of GMP certificate issued
by Drugs Control Administration Government of
Andhra Pradesh India dated 20-06-2022. The
certificate is valid for 3 years.
approval from DRAP (in case of import). cleared by AD (I&E) DRAP dated 24-02-2022.
The invoice specifies 1kg Roxadustat.
3
Evaluation by PEC :


this product.
2. Specify the concentration of each solution
used in the verification studies of the
analytical method of drug substance.
3. Justify the results of CDP studies in which
the drug product shows more than 85%
release in 0.1N HCl and 4.5pH buffer in 30
minutes, since the innovator’s product
review reveals that very less drug release is
observed in 0.1N HCl and 4.5 buffer.
4. Provide image / snapshot of the pack of the
reference product against which
pharmaceutical equivalence and CDP studies
were conducted.
5. Provide scientific rationale for selection of
dissolution parameters and acceptance
criteria.
6. Provide BMR for the three stability batches.
☐ Importer
giver)
2021.
section (General).
☐ Export sale
Pradesh, India.
product.
months.
and stability.
dissolution medium.
Description of Pack
Alu-Alu blister
Batch No. RDM-001 RDM-002 RDM-003
No. of Batches 03
Board.
testing.
3
Evaluation by PEC :


this product.
were conducted.
criteria.
☐ Importer
giver)
2021.
section (General).
☐ Export sale
Pradesh, India.
product.
months.
and stability.
dissolution medium.
Description of Pack
Alu-Alu blister
Batch No. RDH-001 RDH-002 RDH-003
No. of Batches 03
Board.
testing.
3
Evaluation by PEC :


this product.
3. The pharmaceutical equivalence studies have
been performed for 50mg strength of applied
product. Clarification is required in this
regard.
were conducted.
criteria.
378. Name, address of Applicant / Marketing M/s Kaizen Pharmaceuticals (Pvt) Ltd. E-127-
Authorization Holder 129, North Western Industrial Zone, Bin
Qasim Karachi.
Name, address of Manufacturing site. M/s Kaizen Pharmaceuticals (Pvt) Ltd. E-127-
129, North Western Industrial Zone, Bin Qasim
Karachi.
☐ Importer
giver)
2019.
Firm has submitted copy of inspection report
dated 11-08-2020 which concludes that overall
cGMP compliance of the firm was satisfactory.
Evidence of approval of manufacturing facility Firm has submitted copy of letter of issuance of
section (General).
☐ Export sale
The proposed proprietary name / brand name ROXASTAT Tablet 20mg
Pharmaceutical form of applied drug Yellow colored round biconvex film coated
tablets.
Proposed Pack size 10’s, 20’s, 30’s
Name and address of API manufacturer. Zhejiang Hongyuan Pharmaceutical Co., Ltd.
Chem & API’s Industrial Zone, Linhai, Zhejiang,
P.R. China
product.
months.
and stability.
dissolution medium.
Manufacturer of API Zhejiang Hongyuan Pharmaceutical Co., Ltd. Chem & API’s Industrial
Zone, Linhai, Zhejiang, P.R. China
Description of Pack
Alu-PVC blister
Batch No. TF-01 TF-02 TF-03
No. of Batches 03
1. Reference of previous approval of applications Last product specific inspection of firm was
with stability study data of the firm (if any) conducted for “Rofair 500mcg Tablet”, which was
conducted on 25th June, 2019, and was presented
in 290th meeting of Registration Board.
testing.
3. Documents for the procurement of API with Firm has submitted copy of Form 6 License to
approval from DRAP (in case of import). import drugs for clinical trials examination, test of
analysis dated 30-06-2020 for 0.5Kg roxadustat.
5. Compliance Record of HPLC software 21CFR & Firm has not submitted audit trail reports
3
Evaluation by PEC :

this product.
2. 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.”
3. The analytical method of the drug substance
specifies that the concentration of standard
and sample solution is 0.04mg/ml, while in
verification studies the accuracy test is
performed at a concentration range of
0.16mg/ml to 0.24mg/ml. Justify how this
verification studies are applicable to the
analytical method.
4. The concentration of the sample solution
used in precision studies is different from
that concentration of standard and sample
solution in assay method. Clarify how you
have developed the protocols for verification
studies.
5. Justify the accelerated stability studies of the
drug substance performed till 12 months.
6. Provide master formulation as per the CTD
guidance document in section 3.2.P.1
7. Justify the performance of CDP studies in
which time points for 0.1N HCl and 4.5pH
buffer is not taken as per WHO guidelines,
since you have stopped the study samples
before 85% drug release or before plateau is
achieved.
criteria.
9. Provide results of validation studies of the
analytical method of drug product along with
complete protocols as per ICH guidelines.
Provide tabulated results for each test along
with concentration of each solution and
number of replicates used to study the
average.
10. Submit valid GMP certificate / DML of the
drug substance manufacturer, since the
submitted GMP certificate is issued by
Linhai Food and Drug Association which is
not the relevant regulatory authority.
not.
12. As per submitted Form 6, license to import,
0.5Kg of roxadustat was allowed for import
while as per your COA of raw material the
quantity of the raw material received and
tested was 2.7gm. Clarification is required in
this regard.
Qasim Karachi.
Karachi.
☐ Importer
giver)
2019.
section (General).
☐ Export sale
Pharmaceutical form of applied drug Peach colored round biconvex film coated tablets.
P.R. China
product.
months.
and stability.
dissolution medium.
Description of Pack
Alu-PVC blister
No. of Batches 03
testing.
3
Evaluation by PEC :

this product.
required.”
analytical method.
studies.
7. Justify how drug release at a later point is less
than the drug release at earlier time point i.e.
the average drug release after 30 mins in
0.1N HCl was 19.91% while the drug release
in same medium after 45 minutes become
15.29%.
achieved.
criteria.
average.
not.
this regard.
Qasim Karachi.
Karachi.
☐ Importer
giver)
2019.
section (General).
☐ Export sale
Pharmaceutical form of applied drug Peach colored round biconvex film coated tablets.
P.R. China
product.
months.
and stability.
dissolution medium.
Description of Pack
Alu-PVC blister
No. of Batches 03
testing.
3
Evaluation by PEC :

this product.
required.”
analytical method.
studies.
achieved.
criteria.
average.
not.
this regard.
381. Name, address of Applicant / Marketing M/s CCL Pharmaceuticals (Pvt) Ltd. 62-
Authorization Holder Industrial Estate, Kot Lakhpat, Lahore
Name, address of Manufacturing site. M/s CCL Pharmaceuticals (Pvt) Ltd. 62-Industrial
Estate, Kot Lakhpat, Lahore
☐ Importer
giver)
2019.
Firm has also submitted a letter from additional
director DRAP Lahore dated 07-07-2022 that firm
has applied for GMP inspection and application is
under process. The Firm’s last GMP status in
compliant / Good.
section (General).
☐ Export sale
The proposed proprietary name / brand name ROXA Tablet 20mg
Pharmaceutical form of applied drug Pink colored round biconvex film coated tablets.
Proposed Pack size 5’s, 10’s, 14’s, 20’s, 28’s, 30’s, 50’s, 100’s
Pradesh, India.
product.
months.
and stability.
dissolution medium.
Srikakulam Distri 532409, Andhra Pradesh, India.
Description of Pack
Alu-alu blister
Batch No. ROXA-T2-22 ROXA-T3-22 ROXA-T4-22
No. of Batches 03
with stability study data of the firm (if any) conducted for the product Dexlan DR Capsule 30
and 60mg conducted on 26-08-2019 which was
considered by Registration Board in its 294th
meeting. The Board approved the case and
following things were noted in the inspection
report:
 HPLC used in the stability studies of current
products was gradient and not 21CFR 11
compliant.
 The audit trail was not active on the testing
reports and log of data was available in the
HPLCs. The data was also confirmed through
record, chromatograms and logbooks.
authority of country of origin. Andhra Pradesh India dated 20-06-2022. The
3. Documents for the procurement of API with Firm has submitted copy of clearance certificate
approval from DRAP (in case of import). dated 13-07-2022 specifying import of 1.3Kg
Roxadustat (Form A).
6. Record of Digital data logger for temperature and Firm has submitted of digital data logger for
Evaluation by PEC3:

1. You have used Form A polymorphic form of
the drug substance, provide scientific
evidence that the same polymorphic form is
also used by the innovator’s product.
2. Submit complete accelerated stability studies
of the drug substance, since the submitted
studies are only till 2 months.
3. Provide details about the manufacturer of the
innovator’s product against which
were conducted.
4. The CDP studies at 6.8pH phosphate buffer
shows that more than 85% drug is released at
10 minutes’ time point, while in dissolution
studies where the dissolution medium is
same i.e. 6.8pH phosphate buffer, the
acceptance criteria is NLT 75%(Q) in 30
minutes. Provide scientific justification how
your dissolution method is discriminatory in
nature.
5. Specify the exact date of initiation of stability
studies for each batch instead of mentioning
the month.
☐ Importer
giver)
2019.
compliant / Good.
section (General).
☐ Export sale
Pradesh, India.
product.
months.
and stability.
dissolution medium.
Description of Pack
Alu-alu blister
Batch No. ROXB-T2-22 ROXB-T3-22 ROXB-T4-22
No. of Batches 03
report:
compliant.
3
Evaluation by PEC :

were conducted.
nature.
the month.
☐ Importer
giver)
2019.
compliant / Good.
section (General).
☐ Export sale
Pradesh, India.
product.
months.
and stability.
dissolution medium.
Description of Pack
Alu-alu blister
Batch No. ROXC-T2-22 ROXC-T3-22 ROXC-T4-22
No. of Batches 03
report:
compliant.
Evaluation by PEC3:

were conducted.
nature.
the month.
☐ Importer
giver)
2019.
compliant / Good.
section (General).
☐ Export sale
The proposed proprietary name / brand name LASMIN Tablet 50mg
Pharmaceutical ingredient (API) per unit Lasmiditan hemisuccinate eq to
lasmiditan………50mg
Pharmaceutical form of applied drug Light brown-colored round biconvex film coated
tablets
Pharmacotherapeutic Group of (API) Selective serotonin (5HT1) agonists
Clinical Indication REYVOW® is indicated for the acute treatment
of migraine with or without aura in adults.
Limitations of Use REYVOW is not indicated for
the preventive treatment of migraine.
The status in reference regulatory authorities Reyvow Tablet (USFDA Approved)
Name and address of API manufacturer. Enantiotech Corporation Limited. No. 6,
Zhongjing Road, Zhongshan Torch Hi-Tech
Industrial Development Zone, Zhongshan City,
Guangdong Province China.
product.
months.
and stability.
against Reyvow tablet 50mg manufactured by M/s
Lilly USA LLC.
product against Reyvow tablet 50mg
manufactured by M/s Lilly USA LLC in 3
dissolution medium.
Manufacturer of API Enantiotech Corporation Limited. No. 6, Zhongjing Road, Zhongshan
Torch Hi-Tech Industrial Development Zone, Zhongshan City,
API Lot No. LAS09-220302
Description of Pack
Alu-alu blister
Batch No. LASA-T2-22 LASA-T3-22 LASA-T4-22
No. of Batches 03
report:
compliant.
Lasmiditan.
3
Evaluation by PEC :
 On October 11, 2019, the U.S. Food and Drug Administration approved a new drug application for
Reyvow (lasmiditan) tablets for oral use. Lasmiditan is chemically known as [2,4,6-trifluoro-N-(6-
(1-methylpiperidine-4-carbonyl)pyridine-2-yl-benzamide]. Thereafter, the Department of Health
and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling
recommendation to place lasmiditan in schedule V of the Controlled Substances Act (CSA). In
accordance with the CSA, as revised by the Improving Regulatory Transparency for New Medical
Therapies Act, DEA is hereby issuing an interim final rule placing lasmiditan, including its salts,
isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is
possible, in schedule V of the CSA.
Sr. No Shortcomings / Observations Response by the firm
1. Specify the exact polymorphic form of drug
substance used in the development of applied
product.
2. The quality review depicts that particle size
distribution of the drug substance was
controlled by innovator’s product. Justify
how you have developed your product
without controlling the particle size.
99.7%, similarly average drug release in
6.8pH buffer after 15 minutes was 100.1%
while it declined to 99.4% after 20 minutes
and 98.8% after 30 minutes.
4. Justify the acceptance criteria if
disintegration test i.e. NMT 30 minutes while
more than 80% drug is dissolved within 15
minutes.
5. The quality review of the innovator’s product
depicts that disintegration test was used by
the innovator’s product since it has more
discriminatory power as compared to the
dissolution test. While you have used
dissolution test and kept a wide acceptance
criteria of disintegration test to compromise
its discriminatory power. Clarify how your
specifications can be considered equivalent
to that of the innovator’s product and how
batch to batch consistency in drug release be
ensured.
manufacturer of drug substance, issued by
relevant regulatory authority of the country
of origin since the submitted GMP certificate
is issued by Guangdong pharmaceutical
industry association which is not a concerned
regulatory authority.
the month.
shortcomings and evaluation by PE&R Division. Moreover, the Board also decided that the case shall
be forwarded to Controlled Drug Division for their comments on the scheduling of the drug by
USFDA.
☐ Importer
giver)
2019.
compliant / Good.
section (General).
☐ Export sale
The proposed proprietary name / brand name LASMIN Tablet 100mg
Pharmaceutical ingredient (API) per unit Lasmiditan hemisuccinate eq to
lasmiditan………100mg
Pharmaceutical form of applied drug Light brown-colored biconvex tablets
Pharmacotherapeutic Group of (API) Selective serotonin (5HT1) agonists
Clinical Indication REYVOW® is indicated for the acute treatment
of migraine with or without aura in adults.
Limitations of Use REYVOW is not indicated for
the preventive treatment of migraine.
The status in reference regulatory authorities Reyvow Tablet (USFDA Approved)
Name and address of API manufacturer. Enantiotech Corporation Limited. No. 6,
Zhongjing Road, Zhongshan Torch Hi-Tech
Industrial Development Zone, Zhongshan City,
product.
months.
and stability.
against Reyvow tablet 50mg manufactured by M/s
Lilly USA LLC.
product against Reyvow tablet 50mg
manufactured by M/s Lilly USA LLC in 3
dissolution medium.
Manufacturer of API Enantiotech Corporation Limited. No. 6, Zhongjing Road, Zhongshan
Torch Hi-Tech Industrial Development Zone, Zhongshan City,
API Lot No. LAS09-220302
Description of Pack
Alu-alu blister
Batch No. LASB-T2-22 LASB-T3-22 LASB-T4-22
No. of Batches 03
report:
compliant.
Lasmiditan.
3
Evaluation by PEC :
 On October 11, 2019, the U.S. Food and Drug Administration approved a new drug application for
Reyvow (lasmiditan) tablets for oral use. Lasmiditan is chemically known as [2,4,6-trifluoro-N-(6-
(1-methylpiperidine-4-carbonyl)pyridine-2-yl-benzamide]. Thereafter, the Department of Health
and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling
recommendation to place lasmiditan in schedule V of the Controlled Substances Act (CSA). In
accordance with the CSA, as revised by the Improving Regulatory Transparency for New Medical
Therapies Act, DEA is hereby issuing an interim final rule placing lasmiditan, including its salts,
isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is
possible, in schedule V of the CSA.
Sr. No Shortcomings / Observations Response by the firm

1. Specify the exact polymorphic form of drug
substance used in the development of applied
product.
2. The quality review depicts that particle size
distribution of the drug substance was
controlled by innovator’s product. Justify
how you have developed your product
without controlling the particle size.
99.8%, similarly average drug release in
0.01N HCl after 15 minutes was 100.4%
while it declined to 99.9% after 20 minutes
and 98.8% after 30 minutes.
4. Justify the acceptance criteria if
disintegration test i.e. NMT 30 minutes while
more than 80% drug is dissolved within 15
minutes.
5. The quality review of the innovator’s product
depicts that disintegration test was used by
the innovator’s product since it has more
discriminatory power as compared to the
dissolution test. While you have used
dissolution test and kept a wide acceptance
criteria of disintegration test to compromise
its discriminatory power. Clarify how your
specifications can be considered equivalent
to that of the innovator’s product and how
batch to batch consistency in drug release be
ensured.
manufacturer of drug substance, issued by
relevant regulatory authority of the country
of origin since the submitted GMP certificate
is issued by Guangdong pharmaceutical
industry association which is not a concerned
regulatory authority.
the month.
shortcomings and evaluation by PE&R Division. Moreover, the Board also decided that the case shall
be forwarded to controlled drug division for their comments on the scheduling of the drug by
USFDA.
386. Name, address of Applicant / Marketing M/s Crystolite Pharmaceuticals, Plot No. 1, 2,
Authorization Holder Street S-2, National Industrial Zone Rawat.
Name, address of Manufacturing site. M/s Crystolite Pharmaceuticals, Plot No. 1, 2,
Street S-2, National Industrial Zone Rawat.
☐ Importer
giver)
of issued on the basis of inspection dated 08-08-
2022.
Evidence of approval of manufacturing facility The firm has submitted copy of letter of renewal
of DML dated 06-03-2019 specifying Cream /
Ointment Section (General) as well as Cream /
Ointment Section (Steroid)
☐ Export sale
The proposed proprietary name / brand name RUXOLITINIB 1.5% Cream
Strength / concentration of drug of Active Each gram of cream contains:
Pharmaceutical ingredient (API) per unit Ruxolitinib phosphate………15mg
Pharmaceutical form of applied drug White to off-white colored cream filled in
aluminium tube
Pharmacotherapeutic Group of (API) D11AH09: Agents for dermatitis, excluding
corticosteroids
L01EJ01: Protein Kinase Inhibitors
Clinical Indications  OPZELURA is indicated for the topical short-
term and non-continuous chronic treatment of
mild to moderate atopic dermatitis in non-
immunocompromised adult and pediatric
patients 12 years of age and older whose disease
is not adequately controlled with topical
prescription therapies or when those therapies
are not advisable.
 OPZELURA is indicated for the topical
treatment of nonsegmental vitiligo in adult and
pediatric patients 12 years of age and older.
Proposed Pack size 5g
The status in reference regulatory authorities Opzelura 1.5% cream (USFDA Approved)
Name and address of API manufacturer. Chongqing Huapont Schengchem Pharmaceutical
Co. Ltd., No. 666 Rongjun Road, Nanjin Avenue
Hechuan District Chongqing China
product.
months.
and stability.
against Opzelura 1.5% Cream.
drug product.
Manufacturer of API Chongqing Huapont Schengchem Pharmaceutical Co. Ltd., No. 666
Rongjun Road, Nanjin Avenue Hechuan District Chongqing China
API Lot No. RUXO-20220603
Description of Pack
Blister in bleach board unit carton
Batch No. 001T23 002T23 003T23
Batch Size 90 Tubes 90 Tubes 90 Tubes
No. of Batches 03
with stability study data of the firm (if any) conducted for the product Dapazin-M 5/1000 mg
Tablet which was considered by Registration
Board in its 307th meeting which confirms
following:
 Firm has 21 CFR compliant HPLC system
 Audit trail reports were available
 Proper and continuous monitoring record for
stability chamber is available along with backup
generator.
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of DML of the firm (No.
manufacturer issued by concerned regulatory Yu 20150075) issued by NMPA China and also
authority of country of origin. verified online from NMPA database. The
certificate is valid till 09-08-2025.
approval from DRAP (in case of import). issued by AD (I&E) dated 02-11-2022 specifying
35gm.
5. Compliance Record of HPLC software 21CFR & Firm has submitted HPLC audit trail reports
Evaluation by PEC:
 The applied product falls under the pharmacological class of L01 as well as D11, while Registration
Board in its 297th meeting decided to allow manufacturing of drugs falling in L01 class in
anticancer section only. Clarification is required regarding manufacturing of the applied product in
general section.
 The innovator’s product contains 15mg roxulitinib as phosphate per gram of cream while you have
applied 15mg roxulitinib phosphate per gram. Revise your label claim along with submission of
full fee of registration.
 Specify the exact concentration of each solution used in the verification studies of the analytical
method of drug substance performed by drug product manufacturer.
 Submit CoA of reference standard actually used in the analysis.
 Submit stability study data of drug substance till assigned shelf life since the submitted data is for
12 months only.
 Submit image / picture / snapshot of the innovator’s product against which pharmaceutical
equivalence and CDP studies were conducted.
 FDA review report of the innovator’s product reveals that “The applicant has developed and
validated an in-vitro release testing (IVRT) method using a vertical diffusion cell apparatus which
will mainly be used for the determination of comparability drug product if post-approval
manufacturing changes are made. The proposed IVRT method is not intended for routine release
and stability testing”. Justify how comparability of your formulation can be made with the
innovator’s product.
 Specify the exact concentration of each solution used in the verification studies of the analytical
method of drug product.
 Submit stability study data till 6 moths, since only 3month stability data is submitted.
shortcomings and evaluation by PE&R Division. Moreover, the Board also decided that further
deliberation shall be made in upcoming meeting regarding manufacturing requirements for drugs
having multiple WHO ATC classification including L01.
☐ Importer
giver)
2022.
of DML dated 06-03-2019 specifying Soft Gelatin
Capsule Section (General).
☐ Export sale
The proposed proprietary name / brand name OCTINO 10mg soft gel capsule
Strength / concentration of drug of Active Each soft gelatin capsule contains:
Pharmaceutical ingredient (API) per unit Alitretinoin………10mg
Pharmaceutical form of applied drug Light brown oval shaped soft gelatin capsule
containing yellow to orange color viscous
suspension
corticosteroids
L01XF02: Other Antineoplastic Agents
Clinical Indications Toctino is indicated for use in adults who have
severe chronic hand eczema that is unresponsive
to treatment with potent topical corticosteroids.
Patients in whom the eczema has predominantly
hyperkeratotic features are more likely to respond
to treatment than those in whom the eczema
predominantly presents as pompholyx
The status in reference regulatory authorities Toctino 10mg Soft Gelatin Capsule (MHRA
Approved)
product.
stability data is conducted at 5°C ± 3°C for 6
months. The real time stability data is conducted
at -20°C ± 5°C for 9 months.
and stability.
against Toctino Soft Gelatin Capsule.
Firm has submitted results of CDP studies in 3
medium for their product against Toctino Soft
Gelatin Capsule.
drug product.
API Lot No. ALI-20171201
Description of Pack
Batch No. 022T18 023T18 024T18
No. of Batches 03
1. Reference of previous approval of applications NA
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of DML (No. Yu
manufacturer issued by concerned regulatory 20150075) issued by CFDA China. The certificate
authority of country of origin. is valid till 09-08-2025.
3. Documents for the procurement of API with Firm has submitted copy ofclearance certificate
approval from DRAP (in case of import). dated 21-02-2018 which mention 100g alitretinoin.
5. Compliance Record of HPLC software 21CFR & Firm has not submitted HPLC audit trail reports
Evaluation by PEC:
Sr. No Shortcomings Response by the firm

1. The applied product falls under the Applied product falls under L01 as well as
pharmacological class of L01 as well as D11, but we want to to register the product for
D11, while Registration Board in its 297th the purpose of skin which only falls under
meeting decided to allow manufacturing of D11 for which special section is not required.
drugs falling in L01 class in anticancer Decision of 297th meeting of Registration
section only. Clarification is required Board:
regarding manufacturing of the applied Registration Board after thorough
product in general section. deliberation and considering the high-risk
classification i.e., “Anticancer (L01)”, and
reviewing its previous decision decided to
allow the manufacturing of such type of drugs
which fall in both “Antineoplastic (L01)” &
“Immunosuppressants (L04)” class including
everolimus and methotrextare etc. in the
“Anti-cancer” section only (being high risk
products).
2. Specify the exact concentration of each Firm has submitted verification studies and
solution used in the verification studies of mentioned %age of each solution
the analytical method of drug substance
performed by drug product manufacturer.
3. Submit CoA of reference standard actually Firm has submitted COA of working standard
used in the analysis.
4. Clarification is required how the required Material was received in air tight sealed
storage conditions of the drug substance container with having multiple ice bag from
was met during transportation and storage supplier. We atored the material in
within the premises since the drug pharmaceutical freezer in our premises.
substance shall be stored at -20 degree.
5. Submit image / picture / snapshot of the Submitted the firm
pharmaceutical equivalence and CDP
studies were conducted.
6. Justify why assay test of alpha-tocopherol We have used alpha tocopherol as an
is not included in the drug product excipient and validation study of product
specificatons while the same test is shows that there is no effect of testing on
recommended by the innovator’s product. alitretinoin.
7. Provide scientific justification for Firm has submitted detailed justification as
adaptation of dissolution parameters and per USP guidelines.
dissolution time.
the analytical method of drug product.
9. CDP studies result show very little drug CDP was performed in 3 medium (0.1N HCl
release in all medium while in dissolution pH 1.2, 4.5pH acetate buffer, and 6.8pH
test the drug show more than 85% release phosphate buffer. While in dissolution studies
in 6.8pH medium. Clarification is required we have used medium borate buffer pH 8.0
in this regard. containing 0.5% cetrimide 50mg/ml
pancreatin.
Decision: Registration Board deferred the case for further deliberation shall be made in upcoming
meeting regarding manufacturing requirements for drugs having multiple WHO ATC classification
including L01.
☐ Importer
giver)
2022.
of DML dated 06-03-2019 specifying Soft Gelatin
Capsule Section (General).
☐ Export sale
The proposed proprietary name / brand name OCTINO 30mg soft gel capsule
Strength / concentration of drug of Active Each soft gelatin capsule contains:
Pharmaceutical ingredient (API) per unit Alitretinoin………30mg
Pharmaceutical form of applied drug Light brown oval shaped soft gelatin capsule
containing yellow to orange color viscous
suspension
corticosteroids
L01XF02: Other Antineoplastic Agents
Clinical Indications Toctino is indicated for use in adults who have
severe chronic hand eczema that is unresponsive
to treatment with potent topical corticosteroids.
Patients in whom the eczema has predominantly
hyperkeratotic features are more likely to respond
to treatment than those in whom the eczema
predominantly presents as pompholyx
The status in reference regulatory authorities Toctino 10mg Soft Gelatin Capsule (MHRA
Approved)
product.
stability data is conducted at 5°C ± 3°C for 6
months. The real time stability data is conducted
at -20°C ± 5°C for 9 months.
and stability.
against Toctino Soft Gelatin Capsule.
Firm has submitted results of CDP studies in 3
medium for their product against Toctino Soft
Gelatin Capsule.
drug product.
API Lot No. ALI-20171201
Description of Pack
Batch No. 001T19 002T19 003T19
No. of Batches 03
1. Reference of previous approval of applications NA
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of DML (No. Yu
manufacturer issued by concerned regulatory 20150075) issued by CFDA China. The certificate
authority of country of origin. is valid till 09-08-2025.
3. Documents for the procurement of API with Firm has submitted copy ofclearance certificate
approval from DRAP (in case of import). dated 21-02-2018 which mention 100g alitretinoin.
5. Compliance Record of HPLC software 21CFR & Firm has not submitted HPLC audit trail reports
Evaluation by PEC:
Sr. No Shortcomings Response by the firm

1. The applied product falls under the Applied product falls under L01 as well as
pharmacological class of L01 as well as D11, but we want to to register the product for
D11, while Registration Board in its 297th the purpose of skin which only falls under
meeting decided to allow manufacturing of D11 for which special section is not required.
drugs falling in L01 class in anticancer Decision of 297th meeting of Registration
section only. Clarification is required Board:
regarding manufacturing of the applied Registration Board after thorough
product in general section. deliberation and considering the high-risk
classification i.e., “Anticancer (L01)”, and
reviewing its previous decision decided to
allow the manufacturing of such type of drugs
which fall in both “Antineoplastic (L01)” &
“Immunosuppressants (L04)” class including
everolimus and methotrextare etc. in the
“Anti-cancer” section only (being high risk
products).
the analytical method of drug substance
performed by drug product manufacturer.
3. Submit CoA of reference standard actually Firm has submitted COA of working standard
used in the analysis.
4. Clarification is required how the required Material was received in air tight sealed
storage conditions of the drug substance container with having multiple ice bag from
was met during transportation and storage supplier. We atored the material in
within the premises since the drug pharmaceutical freezer in our premises.
substance shall be stored at -20 degree.
5. Submit image / picture / snapshot of the Submitted the firm
pharmaceutical equivalence and CDP
studies were conducted.
6. Justify why assay test of alpha-tocopherol We have used alpha tocopherol as an
is not included in the drug product excipient and validation study of product
specificatons while the same test is shows that there is no effect of testing on
recommended by the innovator’s product. alitretinoin.
7. Provide scientific justification for Firm has submitted detailed justification as
adaptation of dissolution parameters and per USP guidelines.
dissolution time.
the analytical method of drug product.
9. CDP studies result show very little drug CDP was performed in 3 medium (0.1N HCl
release in all medium while in dissolution pH 1.2, 4.5pH acetate buffer, and 6.8pH
test the drug show more than 85% release phosphate buffer. While in dissolution studies
in 6.8pH medium. Clarification is required we have used medium borate buffer pH 8.0
in this regard. containing 0.5% cetrimide 50mg/ml
pancreatin.
Decision: Registration Board deferred the case for further deliberation shall be made in upcoming
meeting regarding manufacturing requirements for drugs having multiple WHO ATC classification
including L01.
b. Deferred cases of local manufacturing
389. Name, address of Applicant / Marketing M/s Wezen Pharmaceuticals, Plot No. 23 & 24, S-
Authorization Holder 1, RCCI Industrial Estate, Rawat
Name, address of Manufacturing site. M/s Wezen Pharmaceuticals, Plot No. 23 & 24, S-1,
RCCI Industrial Estate, Rawat
☐ Importer
GMP status of the firm
Evidence of approval of manufacturing facility Firm has submitted copy of letter of grant of
additional section dated 30-12-2020 for following 4
sections.
 Tablet (General)
 Capsule (General)
 Sachet (General)
 Oinment / Cream / Gel (General)
☐ Export sale
The proposed proprietary name / brand name DEXZEN 30mg Capsule
Pharmaceutical ingredient (API) per unit Dexlansoprazole (as dual delayed release
pellets)………….30mg
Pharmaceutical form of applied drug Small white round enteric coated pellets
encapsulated in hard gelatin capsule
The status in reference regulatory authorities Dexilant capsule USFDA Approved
For generic drugs (me-too status) Razodex Capsule by Getz Pharma
Name and address of API manufacturer. Vision Pharmaceuticals, Plot No. 22-23, Industrial
drug product.
analysis and justification of specification, reference
30°C ± 2°C / 65 ± 5% RH for 24 months.
Pharmaceutical Equivalence and Comparative
Dissolution Profile
Analytical method validation/verification of product Firm has submitted verification studies of the drug
substance and the drug product.
Manufacturer of API Vision Pharmaceuticals, Plot No. 22-23, Industrial Triangle Kahuta Road
Islamabad.
API Lot No.
Description of Pack
Alu-alu blister
No. of Batches 03
1. Reference of previous approval of applications with
manufacturer issued by concerned regulatory by Additional Director DRAP, Islamabad dated 31-
authority of country of origin. 07-2019. The GMP certificate was granted based on
inspection dated 11-02-2019. The GMP certificate is
valid till 10-02-2022.
3. Documents for the procurement of API with approval Firm has submitted copy of commercial invoice
from DRAP (in case of import). dated 23-02-2021 specifying purchase of 2Kg
dexlansoprazole pellets 22.5%.
4. Data of stability batches will be supported by attested Firm has submitted complete record of testing of all
respective documents like chromatograms, Raw data batches along with raw data sheets, COA and
sheets, COA, summary data sheets etc. summary data sheets.
5. Compliance Record of HPLC software 21CFR & audit The firm submitted that their HPLC system is not 21
trail reports on product testing CFR compliant therefore the audit trail reports are
not applicable.
3
Evaluation by PEC :
 GMP certificate / inspection report of the firm conducted within a period of last three years.
 Provide Quality Overall Summary in module 2 as per WHO QOS PD template or as per the template
defined by Registration Board by providing summarized data in the tabulated form. You have submitted
same data of module 3 in QOS as well which is not in line with the CTD guidance document.
 Submit data in section 3.2.S.4.1 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.”
 Provide complete report of verification studies of the analytical method of drug substance performed by
drug product manufacturer in section 3.2.S.4.3, since you have only submitted tabulated results without
any method and procedures for preparation of each type of solution. Furthermore, you have performed 6
replicates in specificity test which is not in line with the recommendations of ICH.
 Provide COA of relevant batch of drug substance from both API manufacturer as well as drug product
manufacturer which is used in the manufacturing of batches of drug product, since you have submitted
COA of multiple irrelevant batches in this section.
 Provide COA of the reference standard / working standard in section 3.2.S.5 which is actually used in the
analysis of drug substance / pellets along with its standardization record with the primary standard, since
you have submitted COA of batch No WS/RLP/01 from Integrin Life Sciences whose product description
is different from that specified in section 3.2.S.1 of your application and is neither the manufacturer of
these pellets or any other source of reference standard manufacturing.
 Section 3.2.S.6 specifies that the API manufacturer is using food grade double polyethylene bag for storing
these pellets which are highly sensitive to moisture and light. Justification is required in this regard.
 Provide information in section 3.2.S.7.1 amd 3.2.S.7.2 as per CTD guidance document since you have only
submitted stability data sheets in section 3.2.S.7 which is not in line with the Form 5-F as well as CTD
guidance document.
 The stability study of dexlansoprazole pellets performed by Vision Pharmaceuticals specify that the pellets
were stored in PET sealed bottles during stability studies while as per section 3.2.S.6 the packaging material
of commercially manufactured pellets is food grade double polyethylene bag. Justify how these stability
studies are applicable in this case and how it represents the true shelf life of the commercially manufactured
pellets.
 Registration Board in its 276th meeting held on 22-25th November, 2017 reviewed the formulation of
dexlansoprazole pellets wherein the representative from the pellets manufacturer appeared before the
Board and admitted that previously they were not specifying testing of pellets at 5.5 pH in the COA. The
submitted stability study data of the three batches of pellets manufactured in 2014 is submitted in which
testing at pH 5.5 is also specified. Clarification is required in this regard.
 Submit complete information in section 3.2.P.1 as per form 5F without skipping any section or heading.
 Submit pharmaceutical equivalence report of the applied product along with reference / innovator’s product
in which all tests as per specifications shall be perfomed, since you have mentioned that pharmaceutical
equivaelence is not required and then you have also provided a brief report of dexlansoprazole tablet in
which all tests are not performed.
 Provide complete report of comparative dissolution profile along with test parameters, analytical method
and how the results are obtained and analysed, since you have only submitted tabulated and graphical
representation without specifying any parameter.
 Submit information in section 3.2.P.3 as per the guidance document which specifies that “The selection
and optimization of the manufacturing process described in 3.2.P.3.3, in particular its critical aspects, shall
be explained. Any specific manufacturing process development shall be provided e.g., sterilization shall
be explained and justified”.
 Provide information in section 3.2.P.3.2 as per the CTD guidance document which specifies that “A batch
formula for proposed commercial batch size shall be provided that includes a list of all components of the
drug product to be used in the manufacturing process, their amounts on a per batch basis, and a reference
to their quality standards, since you have only submitted the same table which is already provided in section
3.2.P.1.
 Provide information in section 3.2.P.3.3 as per the CTD guidance document which specifies that “A flow
diagram shall be presented giving the steps of the process and showing where materials enter the process.
The critical steps and points at which process controls, intermediate tests or final product controls are
conducted shall be identified. Proposals for the reprocessing of materials (if any) shall be justified. Any
data to support this justification shall be provided in this section. The maximum holding time for bulk
product prior to final packaging shall be stated. The holding time shall be supported by the submission of
stability data if longer than 30 days. For an aseptically processed drug product, sterile filtration of the bulk
and filling into final containers shall preferably be continuous; any holding time shall be justified”.
 Provide information in section 3.2.P.3.4 as per the CTD guidance document which specifies that “Tests
and acceptance criteria shall be provided (with justification, including experimental data) performed at the
critical steps identified in 3.2.P.3.3 of the manufacturing process, to ensure that the process is controlled.”
 Justify why the process validation protocols does not include any step for validation of process of capsule
filling, sealing and blistering. Moreover, no critical steps, sampling plan, and evaluation criteria has been
established.
 Provide specifications of the drug product in section 3.2.P.5.1 along with submission of fee for revision of
specifications since you have submitted Vision pharmaceuticals specifications of pellets in this section.
 Provide complete and analytical procedures of drug product in section 3.2.P.5.2 since you have provided
analytical procedures of pellets in this section. Moreover, in assay test you have mentioned both UV and
HPLC test. Clarification is required in this regard.
 Provide validation studies of the analytical method of drug product in section 3.2.P.5.3.
 Provide batch analysis certificate of three batches of drug product in section 3.2.P.5.4 where you have
provided COA of dexlansoprazole pellets of Vision Pharmaceuticals with same results and your signatures
after removing header containing name of Vision Pharmaceuticals.
 Provide COA of the reference standard / working standard in section 3.2.P.6 which is actually used in the
analysis of drug product along with its standardization record with the primary standard.
 Provide information in section 3.2.P.7 as per the CTD guidance document which specifies that “A detail
of the container closure systems, description of the primary container closure systems, including materials
of construction, unit count or fill size, container size or volume shall be provided.”
 You have mentioned white to off white pellets in section 3.2.P.1 while white and green pellets in section
3.2.P.8.1. Justification is required in this regard.
 Provide information in section 3.2.P.8.1 and 3.2.P.8.2 as per the Form 5F and CTD guidance document,
since you have skipped these two sections and did not provide any information in these sections.
 Justify why only assay and dissolution test at one medium is performed in stability studies as evident from
the submitted stability summary sheets.
 Your drug product specifications submitted in section 3.2.P.5.1 and specifications mentioned in COA of
stability studies are different specifically in terms of dissolution test. Justify how you have performed
stability studies without having any clear written specifications and analytical method.
 Justify the dissolution test in which the acceptance criteria is NLT 75% in 5 hours which is against the
specificatiosn of innovator’s product.
 Justify the dissolution acceptance criteria without specifying the value of Q as well as without identifying
the criteria for analysis of results of dissolution test as per the criteria defined in USP general chapter <711>
as well as defined by Registration Board in its 293rd meeting.
 Provide complete results of dissolution test including result of individual unit of capsule in the summary
sheet or COA since results cannot be analysed without having results of individual units of the capsule.
 Provide stability study data in a proper sequence by providing stability summary sheet of individual batch
along with proper separators to provide COA / raw data sheets along with HPLC chromatograms of
standard and sample for the particular time point of that batch. Your submitted data is without any
sequence, you have provided all COA and raw data sheets together and the rest of the data is also provided
without proper sequence and sperators as per the guidelines of Registration Board. Submit your aligned
data in a sequence so that further evaluation may be carried out.
 Submit stability study data in section 3.2.P.8.3 as per the checklist approved by Registration Board in its
296th meeting and the CTD guidance document, which includes the following:
o Reference of previous approval of applications with stability study data of the firm (if any)
o Approval of API/ DML/GMP certificate of API manufacturer issued by concerned regulatory
o Documents for the procurement of API with approval from DRAP (in case of import).
o Data of stability batches will be supported by attested respective documents like chromatograms,
o Compliance Record of HPLC software 21CFR & audit trail reports on product testing.
o Record of Digital data logger for temperature and humidity monitoring of both stability chambers.
Decision of 323rd meeting of Registration Board:
Registration Board deferred the case for submission of reply to the above cited shortcomings within six months.
Response by the firm:
Sr. No Short coming Annexure

01 GMP certificate /inspection report of the firm Firm has not submitted GMP certificate /
conducted within a period of last three years. inspection report.
02 Provide Quality Overall Summary in module 2 as Firm has not submitted QOS as per WHO
per WHO QOS PD template or as per the template template.
defined by Registration Board by providing
summarized data in the tabulated form. You have
submitted same data of module 3 in QOS as well
which is not in line with the CTD guidance
document.
03 Submit data in section 3.2.S.4.1 as per the Firm has submitted copies of the Drug substance
guidance document approved by Registration specifications and analytical procedures used for
Board which specifies that "Copies of the Drug routine testing of the Drug substance Active
substance specifications and analytical Pharmaceutical Ingredient by both Drug
procedures used for routine testing of the Drug substance & Drug Product manufacturer
substance Active Pharmaceutical Ingredient by
both Drug substance & Drug Product
manufacturer is required."
04 Provide complete report of verification studies of Firm has not submitted report of verification
the analytical method of drug substance studies of the analytical method of drug substance
performed by drug product manufacturer in performed by drug product manufacturer.
section 3.2.S.4.3, since you have only submitted
tabulated results without any procedures for
preparation of each type of solution. Furtherore,
you have performed 6 replicates in specificity test
which is not in line with the recommendations of
ICH.
05 Provide COA of relevant batch of drug substance Firm has submitted COA of batch number
from both API manufacturer as well as drug DLP664.
product manufacturer which is used in the
manufacturing of batches of drug product, since
you have submitted COA of multiple irrelevant
batches in this section.
06 Provide COA of the reference standard / working Firm has not sumitted COA of reference /
standard in section 3.2.S.5 which is actually used working standard.
in the analysis of drug substance / pellets along
with its standardization record with the primary
standard, since you have submitted COA of batch
No WS/RLP/01 from Integrin Life Sciences
whose product description is different from that
specified in section 3.2.S.1 of your application
and is neither the manufacturer of hese pellets or
any other source of reference standard
manufacturing.
07 Section 3.2.S.6 specifies that the API food grade Three polyethylene bag used for packing of
double manufacturer is using polyethylene bag pellets.
for storing these which are pellets highly sensitive Two transparent and one black color bags along
to moisture and light. Justification is required in with silica gel.
this regard.
08 Provide information in section 3.2.S.7.1 and Firm has submitted information in section
3.2.S.7.2 as CTD per guidance document since 3.2.S.7.1 and 3.2.S.7.2 as CTD per guidance
you have only submitted stability data sheets in document.
section 3.2.S.7 which is not in line with the Form
5-F as well as CTD guidance document.
09 The stability study of Vision Dexlansoprazole Study performed at lab scale and in chamber they
pellets performed by Pharmaceuticals specify that placed sample in pet bottle and for commercial
the pellets were stored in PET sealed bottles they provide polythene bags and drum which is
during stability studies while as per section not possible in pet bottle.
3.2.S.6 the packaging material of commercially
manufactured pellets is food grade double
polyethylene bag. Justify how these stability
studies are applicable in this case and how it
represents the true shelf life of the commercially
manufactured pellets.
10 Registration Board in its 276th meeting held on DMF provided by vision pharma
22-25th November, 2017 reviewed the
formulation of Dexlansoprazole pellets wherein
the manufacturer appeared before the Board and
admitted that previously they were not specifying
testing of pellets at 5.5 pH in the COA. The
submitted stability study data of the three batches
of pellets manufactured in 2014 is submitted in
which testing at pH 5.5 is also specified.
Clarifications required in this regard.
11 Submit complete information in section 3.2.P.1 as Submitted by the firm.
per form 5F without skipping any section or
heading.
12 Submit pharmaceutical equivalence report of the Firm has submitted pharmaceutical equivalence
applied product along with reference / innovator's studies against the comparator product
product in which all tests as per specifications manufactured by Weatherfolds pharma.
shall be performed, since you have mentioned that
pharmaceutical equivalence is not required and
then you have also provided a brief report of
Dexlansoprazole tablet in which all tests are not
performed.
13 Provide complete report of comparative Firm has submitted results of comparative
dissolution profile along with test parameters, dissolution profile against the brand leader.
analytical method and how the results are
obtained and analysed, since you have only
submitted tabulated and graphical representation
without specifying any parameter
14 submit information in section 3.2.P.3 as per the Firm has submitted information in section 3.2.P.3
guidance document which specifies that The as per the guidance document.
selection and optimization of the manufacturing
process described in 3.2.P.3.3, in particular its
critical aspects, shall be explained. Any specific
manufacturing process development shall be
provided e.g., sterilization shall be explained and
justified”
15 Provide information in section 3.2.P.3.2 as per the Firm has submitted information in section
CTD guidance document which specifies that "A 3.2.P.3.2 as per the guidance document.
batch formula for proposed commercial batch size
shall be provided that includes a list of all
components of the drug product to be used in the
manufacturing process, their amounts on a per
batch basis, and a reference to their quality
standards, since you have only submitted the
same table which is already provided in section
3.2.P.1
flow diagram shall be presented giving the steps
of the process and showing where materials enter
the process. The critical steps and points at which
process controls, intermediate tests or final
product controls are conducted shall be identified.
Proposals for the reprocessing of materials (if
any) shall be justified. Any data t supports this
justification shall be provided in this section. The
maximum holding time for bulk product prior to
final packaging shall be stated. The holding time
shall be supported by the submission of stability
data if longer than 30 days. For an aseptically
processed drug product, sterile filtration of the
bulk and filling into final containers shall
preferably be continuous; any holding time shall
be justified"
CTD guidance document which specifies that 3.2.P.3.4 as per the guidance document.
"Tests and acceptance criteria shall be provided
(with justification, including experimental data)
performed at the critical steps identified in
3.2.P.3.3 of the manufacturing process, to ensure
that the process is controlled."
18 Justify why the process validation protocols does Firm has not submitted process validation
not include any step for validation of process of protocols.
capsule filling, sealing and blistering. Moreover,
no critical steps, sampling plan, and evaluation
criteria has been established
19 Provide specifications of the drug product in Firm has submitted specifications of the drug
section 3.2.P.5.1 along with submission of fee for product in section 3.2.P.5.1.
revision of specifications since you have
submitted Vision pharmaceuticals specifications
of pellets in this section.
20 provide complete and analytical procedures of Firm has submitted specifications of the drug
drug product in section 3.2.P.5.2 since you have product in section 3.2.P.5.2.
provided analytical procedures of pellets in this
section. Moreover, in assay test you have
mentioned both UV and HPLC test. Clarifications
required in this regard
21 Provide validation studies of the analytical Firm has not submitted complete validation
method of drug product in section 3.2. P.5.3. studies of the analytical method of drug product
in section 3.2. P.5.3.
22 provide batch analysis certificate of three batches Firm has submitted Batch analysis report of 3
of drug product in section 3.2.P.5.4 where you stability batches.
have provided COA of Dexlansoprazole pellets of
Vision Pharmaceuticals with same results and
your signatures after removing header containing
name of Vision Pharmaceuticals.
23 Provide COA of the reference standard I working Firm has not submitted COA of reference
standard in section 3.2.P.6 which is actually used standard / working standard.
in the analysis of drug product along with its
standardization record with the primary standard
24 Provide information in section 3.2.P.7 as per the Firm has submitted details of container closure
CTD guidance document which specifies that "A system.
detail of the container closure systems,
description of the primary container closure
systems, including materials of construction, unit
count or fill size, container size or volume shall
be provided."
25 You have mentioned white to off white pellets in Written mistakenly, revised and correct
section 3.2.P.1 while white and green pellets in submitted.
section 3.2.P.8.1. Justification is required in this
regard
26 Provide information in section 3.2.P.8.1 and Firm has submitted information in section
3.2.P.8.2 as per the Form 5F and CTD guidance 3.2.P.8.1 and 3.2.P.8.2.
document, since you have skipped these two
sections and did not provide any information in
these sections.
27 justify why only assay and dissolution test at one Firm has now submitted dissolution test results at
medium is performed in stability studies as different medium in stability studies.
evident from the submitted stability summary
sheets
28 Your drug product specifications submitted in Firm has submitted specifications and analytical
section 3.2.P.5.1 and specifications mentioned in method of drug product.
COA of stability studies are different specifically
in terms of dissolution test. Justify how you have
performed stability studies without having any
clear written specifications and analytical
method.
29 justify the dissolution test in which the acceptance Typo mistake Revised COA attached
criteria NLT 75% in 5 hours which is against the
specifications of innovator’s product
30 justify the dissolution acceptance criteria without Corrected and resubmitted by the firm
specifying the value of Q as well as without
identifying the criteria for analysis of results of
dissolution test as per the criteria defined in USP
general chapter as well as defined by Registration
Board in its 293d meeting
31 provide complete results of dissolution test Revised COA are submitted by the firm.
including result of individual unit of capsule in
the summary sheet or COA since results cannot
be analysed without having results of individual
units of the capsule
32 provide stability study data in a proper se stability Firm has submitted stability data in a proper
summary sheet of individual batch along with sequence.
proper separators to provide COA / raw data
sheets along with HPLC chromatograms of
standard and sample for the particular time point
of that batch. Your submitted data is without any
sequence, you have provided all COA and raw
data sheets together and the rest of the data is also
provided without proper sequence and separators
as per the guidelines of Registration Board.
Submit your aligned data in a sequence so that
further evaluation may be carried out
33 submit stability study data in section 3.2.P.8.3 as Firm has submitted response against the 6 points
per the checklist approved by Registration Board checklist as per CTD guidance document.
in its 296th meeting and the CTD guidance
document, which includes the following:
 Reference of previous approval of
applications with stability study data of the
firm (if any)
 Approval of API/ DML/GMP certificate of
API manufacturer issued by concerned
regulatory authority of country of origin
 Documents for the procurement of APl with
 Data of stability batches will be supported by
summary data sheets etc
 Compliance Record of HPLC software
testing
 Record of Digital data logger for temperature
and humidity monitoring of both stability
chambers
th
Decision of 324 meeting: Deferred for following observations:
any procedures for preparation of each type of solution. Furtherore, you have performed 6 replicates in
specificity test which is not in line with the recommendations of ICH.
is different from that specified in section 3.2.S.1 of your application and is neither the manufacturer of hese
pellets or any other source of reference standard manufacturing.
established
 Provide validation studies of the analytical method of drug product in section 3.2. P.5.3.
 Provide COA of the reference standard I working standard in section 3.2.P.6 which is actually used in the
analysis of drug product along with its standardization record with the primary standard
Firm’s response:
Sr.# Observation Reply

1. Provide Quality Overall Summary in module 2 as per Submitted
WHO QOS PD template or as per the template defined
by Registration Board by providing summarized data
in the tabulated form. You have submitted same data
of module 3 in QOS as well which is not in line with
the CTD guidance document
2. Provide complete report of verification studies of the Firm has submitted revised analytical
analytical method of drug substance performed by method verification studies performed by
drug product manufacturer in section 3.2.S.4.3, since M/s Wezen Pharmaceuticals.
you have only submitted tabulated results without any
procedures for preparation of each type of solution.
Furtherore, you have performed 6 replicates in
specificity test which is not in line with the
recommendations of ICH.
3. Provide COA of the reference standard / working Firm has submitted COA of working
standard in section 3.2.S.5 which is actually used in the standard form M/s Vision Pharmaceuticals.
analysis of drug substance / pellets along with its
standardization record with the primary standard, since
you have submitted COA of batch No WS/RLP/01
from Integrin Life Sciences whose product description
is different from that specified in section 3.2.S.1 of
your application and is neither the manufacturer of
these pellets or any other source of reference standard
manufacturing.
4. Justify why the process validation protocols does not Firm has submitted revised process
include any step for validation of process of capsule validation protocol including the critical
filling, sealing and blistering. Moreover, no critical steps, sampling plan, and evaluation criteria
steps, sampling plan, and evaluation criteria has been for the process of capsule filling, sealing
established and blistering.
5. Provide validation studies of the analytical method of Submitted.

drug product in section 3.2. P.5.3.
6. Provide COA of the reference standard in working Firm has submitted COA of working
standard in section 3.2.P.6 which is actually used in the standard form M/s Vision Pharmaceuticals.
analysis of drug product along with its standardization
record with the primary standard
Decision of 327th meeting of Registration Board: Deferred for submission of Pharmaceutical equivalence and
Comparative Dissolution Profile (CDP) studies against the innovator’s product.
Response by the firm: Firm has submitted result of pharmaceutical equivalence and CDP studies against
Dexilant 30mg Capsule. Firm has also submitted picture of the pack of the reference product.
390. Name, address of Applicant / Marketing M/s Wezen Pharmaceuticals, Plot No. 23 & 24, S-1,
Authorization Holder RCCI Industrial Estate, Rawat
Name, address of Manufacturing site. M/s Wezen Pharmaceuticals, Plot No. 23 & 24, S-1,
RCCI Industrial Estate, Rawat
☐ Importer
GMP status of the firm
Evidence of approval of manufacturing facility has submitted copy of letter of grant of additional
section dated 30-12-2020 for following 4 sections.
 Tablet (General)
 Capsule (General)
 Sachet (General)
 Oinment / Cream / Gel (General)
☐ Export sale
The proposed proprietary name / brand name DEXZEN 60mg Capsule
Pharmaceutical ingredient (API) per unit Dexlansoprazole (as dual delayed release
pellets)………….60mg
Pharmaceutical form of applied drug Small white round enteric coated pellets encapsulated
in hard gelatin capsule
The status in reference regulatory authorities Dexilant capsule USFDA Approved
For generic drugs (me-too status) Razodex Capsule by Getz Pharma
Name and address of API manufacturer. Vision Pharmaceuticals, Plot No. 22-23, Industrial
template. Firm has summarized information related to
stability studies of drug substance and drug product.
Stability Studies of Drug Substance Firm has submitted stability study data of 3 batches of
(Conditions & duration of Stability studies) 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.
Pharmaceutical Equivalence and Comparative
Dissolution Profile
Manufacturer of API Vision Pharmaceuticals, Plot No. 22-23, Industrial Triangle Kahuta Road
Islamabad.
API Lot No.
Description of Pack
Alu-alu blister
No. of Batches 03
1. Reference of previous approval of applications with
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP certificate issued by
manufacturer issued by concerned regulatory Additional Director DRAP, Islamabad dated 31-07-
authority of country of origin. 2019. The GMP certificate was granted based on
inspection dated 11-02-2019. The GMP certificate is
valid till 10-02-2022.
3. Documents for the procurement of API with Firm has submitted copy of commercial invoice dated
approval from DRAP (in case of import). 23-02-2021 specifying purchase of 2Kg
dexlansoprazole pellets 22.5%.
4. Data of stability batches will be supported by Firm has submitted complete record of testing of all
attested respective documents like chromatograms, batches along with raw data sheets, COA and
Raw data sheets, COA, summary data sheets etc. summary data sheets.
5. Compliance Record of HPLC software 21CFR & The firm submitted that their HPLC system is not 21
audit trail reports on product testing CFR compliant therefore the audit trail reports are not
applicable.
Evaluation by PEC3:
 GMP certificate / inspection report of the firm conducted within a period of last three years.
 Submit data in section 3.2.S.4.1 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.”
any method and procedures for preparation of each type of solution. Furthermore, you have performed 6
replicates in specificity test which is not in line with the recommendations of ICH.
 Provide COA of relevant batch of drug substance from both API manufacturer as well as drug product
manufacturer which is used in the manufacturing of batches of drug product, since you have submitted
COA of multiple irrelevant batches in this section.
 Section 3.2.S.6 specifies that the API manufacturer is using food grade double polyethylene bag for storing
these pellets which are highly sensitive to moisture and light. Justification is required in this regard.
 Provide information in section 3.2.S.7.1 amd 3.2.S.7.2 as per CTD guidance document since you have only
submitted stability data sheets in section 3.2.S.7 which is not in line with the Form 5-F as well as CTD
guidance document.
 The stability study of dexlansoprazole pellets performed by Vision Pharmaceuticals specify that the pellets
were stored in PET sealed bottles during stability studies while as per section 3.2.S.6 the packaging material
of commercially manufactured pellets is food grade double polyethylene bag. Justify how these stability
studies are applicable in this case and how it represents the true shelf life of the commercially manufactured
pellets.
 Registration Board in its 276th meeting held on 22-25th November, 2017 reviewed the formulation of
dexlansoprazole pellets wherein the representative from the pellets manufacturer appeared before the
Board and admitted that previously they were not specifying testing of pellets at 5.5 pH in the COA. The
submitted stability study data of the three batches of pellets manufactured in 2014 is submitted in which
testing at pH 5.5 is also specified. Clarification is required in this regard.
 Submit complete information in section 3.2.P.1 as per form 5F without skipping any section or heading.
 Submit pharmaceutical equivalence report of the applied product along with reference / innovator’s product
in which all tests as per specifications shall be perfomed, since you have mentioned that pharmaceutical
equivaelence is not required and then you have also provided a brief report of dexlansoprazole tablet in
which all tests are not performed.
 Provide complete report of comparative dissolution profile along with test parameters, analytical method
and how the results are obtained and analysed, since you have only submitted tabulated and graphical
representation without specifying any parameter.
 Submit information in section 3.2.P.3 as per the guidance document which specifies that “The selection
and optimization of the manufacturing process described in 3.2.P.3.3, in particular its critical aspects, shall
be explained. Any specific manufacturing process development shall be provided e.g., sterilization shall
be explained and justified”.
 Provide information in section 3.2.P.3.2 as per the CTD guidance document which specifies that “A batch
formula for proposed commercial batch size shall be provided that includes a list of all components of the
drug product to be used in the manufacturing process, their amounts on a per batch basis, and a reference
to their quality standards, since you have only submitted the same table which is already provided in section
3.2.P.1.
 Provide information in section 3.2.P.3.3 as per the CTD guidance document which specifies that “A flow
diagram shall be presented giving the steps of the process and showing where materials enter the process.
The critical steps and points at which process controls, intermediate tests or final product controls are
conducted shall be identified. Proposals for the reprocessing of materials (if any) shall be justified. Any
data to support this justification shall be provided in this section. The maximum holding time for bulk
product prior to final packaging shall be stated. The holding time shall be supported by the submission of
stability data if longer than 30 days. For an aseptically processed drug product, sterile filtration of the bulk
and filling into final containers shall preferably be continuous; any holding time shall be justified”.
 Provide information in section 3.2.P.3.4 as per the CTD guidance document which specifies that “Tests
and acceptance criteria shall be provided (with justification, including experimental data) performed at the
critical steps identified in 3.2.P.3.3 of the manufacturing process, to ensure that the process is controlled.”
established.
 Provide specifications of the drug product in section 3.2.P.5.1 along with submission of fee for revision of
specifications since you have submitted Vision pharmaceuticals specifications of pellets in this section.
 Provide complete and analytical procedures of drug product in section 3.2.P.5.2 since you have provided
analytical procedures of pellets in this section. Moreover, in assay test you have mentioned both UV and
HPLC test. Clarification is required in this regard.
 Provide validation studies of the analytical method of drug product in section 3.2.P.5.3.
 Provide batch analysis certificate of three batches of drug product in section 3.2.P.5.4 where you have
provided COA of dexlansoprazole pellets of Vision Pharmaceuticals with same results and your signatures
after removing header containing name of Vision Pharmaceuticals.
 Provide COA of the reference standard / working standard in section 3.2.P.6 which is actually used in the
analysis of drug product along with its standardization record with the primary standard.
 Provide information in section 3.2.P.7 as per the CTD guidance document which specifies that “A detail
of the container closure systems, description of the primary container closure systems, including materials
of construction, unit count or fill size, container size or volume shall be provided.”
 You have mentioned white to off white pellets in section 3.2.P.1 while white and green pellets in section
3.2.P.8.1. Justification is required in this regard.
 Provide information in section 3.2.P.8.1 and 3.2.P.8.2 as per the Form 5F and CTD guidance document,
since you have skipped these two sections and did not provide any information in these sections.
 Justify why only assay and dissolution test at one medium is performed in stability studies as evident from
the submitted stability summary sheets.
 Your drug product specifications submitted in section 3.2.P.5.1 and specifications mentioned in COA of
stability studies are different specifically in terms of dissolution test. Justify how you have performed
stability studies without having any clear written specifications and analytical method.
 Justify the dissolution test in which the acceptance criteria is NLT 75% in 5 hours which is against the
specificatiosn of innovator’s product.
 Justify the dissolution acceptance criteria without specifying the value of Q as well as without identifying
the criteria for analysis of results of dissolution test as per the criteria defined in USP general chapter <711>
as well as defined by Registration Board in its 293rd meeting.
 Provide complete results of dissolution test including result of individual unit of capsule in the summary
sheet or COA since results cannot be analysed without having results of individual units of the capsule.
 Provide stability study data in a proper sequence by providing stability summary sheet of individual batch
along with proper separators to provide COA / raw data sheets along with HPLC chromatograms of
standard and sample for the particular time point of that batch. Your submitted data is without any
sequence, you have provided all COA and raw data sheets together and the rest of the data is also provided
without proper sequence and sperators as per the guidelines of Registration Board. Submit your aligned
data in a sequence so that further evaluation may be carried out.
 Submit stability study data in section 3.2.P.8.3 as per the checklist approved by Registration Board in its
296th meeting and the CTD guidance document, which includes the following:
o Reference of previous approval of applications with stability study data of the firm (if any)
o Approval of API/ DML/GMP certificate of API manufacturer issued by concerned regulatory
o Documents for the procurement of API with approval from DRAP (in case of import).
o Data of stability batches will be supported by attested respective documents like chromatograms,
o Compliance Record of HPLC software 21CFR & audit trail reports on product testing.
o Record of Digital data logger for temperature and humidity monitoring of both stability chambers.
Decision of 323rd meeting of Registration Board:
Response by the firm:
Sr. No Short coming Annexure

01 GMP certificate /inspection report of the firm Firm has not submitted GMP certificate /
conducted within a period of last three years. inspection report.
02 Provide Quality Overall Summary in module 2 as Firm has not submitted QOS as per WHO
per WHO QOS PD template or as per the template template.
defined by Registration Board by providing
summarized data in the tabulated form. You have
submitted same data of module 3 in QOS as well
which is not in line with the CTD guidance
document.
03 Submit data in section 3.2.S.4.1 as per the Firm has submitted copies of the Drug substance
guidance document approved by Registration specifications and analytical procedures used for
Board which specifies that "Copies of the Drug routine testing of the Drug substance Active
substance specifications and analytical Pharmaceutical Ingredient by both Drug
procedures used for routine testing of the Drug substance & Drug Product manufacturer
substance Active Pharmaceutical Ingredient by
both Drug substance & Drug Product
manufacturer is required."
04 Provide complete report of verification studies of Firm has not submitted report of verification
the analytical method of drug substance studies of the analytical method of drug substance
performed by drug product manufacturer in performed by drug product manufacturer.
section 3.2.S.4.3, since you have only submitted
tabulated results without any procedures for
preparation of each type of solution. Furtherore,
you have performed 6 replicates in specificity test
which is not in line with the recommendations of
ICH.
05 Provide COA of relevant batch of drug substance Firm has submitted COA of batch number
from both API manufacturer as well as drug DLP664.
product manufacturer which is used in the
manufacturing of batches of drug product, since
you have submitted COA of multiple irrelevant
batches in this section.
06 Provide COA of the reference standard / working Firm has not sumitted COA of reference /
standard in section 3.2.S.5 which is actually used working standard.
in the analysis of drug substance / pellets along
with its standardization record with the primary
standard, since you have submitted COA of batch
No WS/RLP/01 from Integrin Life Sciences
whose product description is different from that
specified in section 3.2.S.1 of your application
and is neither the manufacturer of hese pellets or
any other source of reference standard
manufacturing.
07 Section 3.2.S.6 specifies that the API food grade Three polyethylene bag used for packing of
double manufacturer is using polyethylene bag pellets.
for storing these which are pellets highly sensitive Two transparent and one black color bags along
to moisture and light. Justification is required in with silica gel.
this regard.
08 Provide information in section 3.2.S.7.1 and Firm has submitted information in section
3.2.S.7.2 as CTD per guidance document since 3.2.S.7.1 and 3.2.S.7.2 as CTD per guidance
you have only submitted stability data sheets in document.
section 3.2.S.7 which is not in line with the Form
5-F as well as CTD guidance document.
09 The stability study of Vision Dexlansoprazole Study performed at lab scale and in chamber they
pellets performed by Pharmaceuticals specify that placed sample in pet bottle and for commercial
the pellets were stored in PET sealed bottles they provide polythene bags and drum which is
during stability studies while as per section not possible in pet bottle.
3.2.S.6 the packaging material of commercially
manufactured pellets is food grade double
polyethylene bag. Justify how these stability
studies are applicable in this case and how it
represents the true shelf life of the commercially
manufactured pellets.
10 Registration Board in its 276th meeting held on DMF provided by vision pharma
22-25th November, 2017 reviewed the
formulation of Dexlansoprazole pellets wherein
the manufacturer appeared before the Board and
admitted that previously they were not specifying
testing of pellets at 5.5 pH in the COA. The
submitted stability study data of the three batches
of pellets manufactured in 2014 is submitted in
which testing at pH 5.5 is also specified.
Clarifications required in this regard.
11 Submit complete information in section 3.2.P.1 as Submitted by the firm.
per form 5F without skipping any section or
heading.
12 Submit pharmaceutical equivalence report of the Firm has submitted pharmaceutical equivalence
applied product along with reference / innovator's studies against the comparator product
product in which all tests as per specifications manufactured by Weatherfolds pharma.
shall be performed, since you have mentioned that
pharmaceutical equivalence is not required and
then you have also provided a brief report of
Dexlansoprazole tablet in which all tests are not
performed.
13 Provide complete report of comparative Firm has submitted results of comparative
dissolution profile along with test parameters, dissolution profile against the brand leader.
analytical method and how the results are
obtained and analysed, since you have only
submitted tabulated and graphical representation
without specifying any parameter
14 submit information in section 3.2.P.3 as per the Firm has submitted information in section 3.2.P.3
guidance document which specifies that The as per the guidance document.
selection and optimization of the manufacturing
process described in 3.2.P.3.3, in particular its
critical aspects, shall be explained. Any specific
manufacturing process development shall be
provided e.g., sterilization shall be explained and
justified”
batch formula for proposed commercial batch size
shall be provided that includes a list of all
components of the drug product to be used in the
manufacturing process, their amounts on a per
batch basis, and a reference to their quality
standards, since you have only submitted the
same table which is already provided in section
3.2.P.1
flow diagram shall be presented giving the steps
of the process and showing where materials enter
the process. The critical steps and points at which
process controls, intermediate tests or final
product controls are conducted shall be identified.
Proposals for the reprocessing of materials (if
any) shall be justified. Any data t supports this
justification shall be provided in this section. The
maximum holding time for bulk product prior to
final packaging shall be stated. The holding time
shall be supported by the submission of stability
data if longer than 30 days. For an aseptically
processed drug product, sterile filtration of the
bulk and filling into final containers shall
preferably be continuous; any holding time shall
be justified"
CTD guidance document which specifies that 3.2.P.3.4 as per the guidance document.
"Tests and acceptance criteria shall be provided
(with justification, including experimental data)
performed at the critical steps identified in
3.2.P.3.3 of the manufacturing process, to ensure
that the process is controlled."
18 Justify why the process validation protocols does Firm has not submitted process validation
not include any step for validation of process of protocols.
capsule filling, sealing and blistering. Moreover,
no critical steps, sampling plan, and evaluation
criteria has been established
19 Provide specifications of the drug product in Firm has submitted specifications of the drug
section 3.2.P.5.1 along with submission of fee for product in section 3.2.P.5.1.
revision of specifications since you have
submitted Vision pharmaceuticals specifications
of pellets in this section.
20 provide complete and analytical procedures of Firm has submitted specifications of the drug
drug product in section 3.2.P.5.2 since you have product in section 3.2.P.5.2.
provided analytical procedures of pellets in this
section. Moreover, in assay test you have
mentioned both UV and HPLC test. Clarifications
required in this regard
21 Provide validation studies of the analytical Firm has not submitted complete validation
method of drug product in section 3.2. P.5.3. studies of the analytical method of drug product
in section 3.2. P.5.3.
22 provide batch analysis certificate of three batches Firm has submitted Batch analysis report of 3
of drug product in section 3.2.P.5.4 where you stability batches.
have provided COA of Dexlansoprazole pellets of
Vision Pharmaceuticals with same results and
your signatures after removing header containing
name of Vision Pharmaceuticals.
23 Provide COA of the reference standard I working Firm has not submitted COA of reference
standard in section 3.2.P.6 which is actually used standard / working standard.
in the analysis of drug product along with its
standardization record with the primary standard
24 Provide information in section 3.2.P.7 as per the Firm has submitted details of container closure
CTD guidance document which specifies that "A system.
detail of the container closure systems,
description of the primary container closure
systems, including materials of construction, unit
count or fill size, container size or volume shall
be provided."
25 You have mentioned white to off white pellets in Written mistakenly, revised and correct
section 3.2.P.1 while white and green pellets in submitted.
section 3.2.P.8.1. Justification is required in this
regard
26 Provide information in section 3.2.P.8.1 and Firm has submitted information in section
3.2.P.8.2 as per the Form 5F and CTD guidance 3.2.P.8.1 and 3.2.P.8.2.
document, since you have skipped these two
sections and did not provide any information in
these sections.
27 justify why only assay and dissolution test at one Firm has now submitted dissolution test results at
medium is performed in stability studies as different medium in stability studies.
evident from the submitted stability summary
sheets
28 Your drug product specifications submitted in Firm has submitted specifications and analytical
section 3.2.P.5.1 and specifications mentioned in method of drug product.
COA of stability studies are different specifically
in terms of dissolution test. Justify how you have
performed stability studies without having any
clear written specifications and analytical
method.
29 justify the dissolution test in which the acceptance Typo mistake Revised COA attached
criteria NLT 75% in 5 hours which is against the
specifications of innovator’s product
30 justify the dissolution acceptance criteria without Corrected and resubmitted by the firm
specifying the value of Q as well as without
identifying the criteria for analysis of results of
dissolution test as per the criteria defined in USP
general chapter as well as defined by Registration
Board in its 293d meeting
31 provide complete results of dissolution test Revised COA are submitted by the firm.
including result of individual unit of capsule in
the summary sheet or COA since results cannot
be analysed without having results of individual
units of the capsule
32 provide stability study data in a proper se stability Firm has submitted stability data in a proper
summary sheet of individual batch along with sequence.
proper separators to provide COA / raw data
sheets along with HPLC chromatograms of
standard and sample for the particular time point
of that batch. Your submitted data is without any
sequence, you have provided all COA and raw
data sheets together and the rest of the data is also
provided without proper sequence and separators
as per the guidelines of Registration Board.
Submit your aligned data in a sequence so that
further evaluation may be carried out
33 submit stability study data in section 3.2.P.8.3 as Firm has submitted response against the 6 points
per the checklist approved by Registration Board checklist as per CTD guidance document.
in its 296th meeting and the CTD guidance
document, which includes the following:
firm (if any)
 Approval of API/ DML/GMP certificate of
 Documents for the procurement of APl with
 Data of stability batches will be supported by
summary data sheets etc
testing
and humidity monitoring of both stability
chambers
Decision: Deferred for following observations:
any procedures for preparation of each type of solution. Furtherore, you have performed 6 replicates in
specificity test which is not in line with the recommendations of ICH.
Justify why the process validation protocols does not include any step for validation of process of capsule
established
 Provide validation studies of the analytical method of drug product in section 3.2. P.5.3.
 Provide COA of the reference standard I working standard in section 3.2.P.6 which is actually used in the
analysis of drug product along with its standardization record with the primary standard
Firm’s response:
Sr.# Observation Reply

1. Provide Quality Overall Summary in module 2 as per Submitted
WHO QOS PD template or as per the template defined
by Registration Board by providing summarized data
in the tabulated form. You have submitted same data
of module 3 in QOS as well which is not in line with
the CTD guidance document
2. Provide complete report of verification studies of the Firm has submitted revised analytical
analytical method of drug substance performed by method verification studies performed by
drug product manufacturer in section 3.2.S.4.3, since M/s Wezen Pharmaceuticals.
you have only submitted tabulated results without any
procedures for preparation of each type of solution.
Furtherore, you have performed 6 replicates in
specificity test which is not in line with the
recommendations of ICH.
3. Provide COA of the reference standard / working Firm has submitted COA of working
standard in section 3.2.S.5 which is actually used in the standard form M/s Vision Pharmaceuticals.
analysis of drug substance / pellets along with its
standardization record with the primary standard, since
you have submitted COA of batch No WS/RLP/01
from Integrin Life Sciences whose product description
is different from that specified in section 3.2.S.1 of
your application and is neither the manufacturer of
these pellets or any other source of reference standard
manufacturing.
4. Justify why the process validation protocols does not Firm has submitted revised process
include any step for validation of process of capsule validation protocol including the critical
filling, sealing and blistering. Moreover, no critical steps, sampling plan, and evaluation criteria
steps, sampling plan, and evaluation criteria has been for the process of capsule filling, sealing and
established blistering.
5. Provide validation studies of the analytical method of Submitted.

drug product in section 3.2. P.5.3.
6. Provide COA of the reference standard in working Firm has submitted COA of working
standard in section 3.2.P.6 which is actually used in the standard form M/s Vision Pharmaceuticals.
analysis of drug product along with its standardization
record with the primary standard
Decision of 327th meeting of Registration Board: Deferred for submission of Pharmaceutical equivalence and
Comparative Dissolution Profile (CDP) studies against the innovator’s product.
Response by the firm: Firm has submitted result of pharmaceutical equivalence and CDP studies against
Dexilant 60mg Capsule. Firm has also submitted picture of the pack of the reference product.
391. Name, address of Applicant / Marketing M/s Healthtek (pvt) Ltd., Plot no. 14, Sector 19, Korangi
Authorization Holder Industrial Area, Karachi.
Name, address of Manufacturing site. M/s Stallion Pharmaceuticals (pvt) Ltd., 581 sundar industrial
estate, Lahore.
☐ Importer
☐ Export sale
Proposed proprietary name / brand name Cilomen 500mg injection
Strength/ concentration of drug of Each vial contains:
Active Pharmaceutical ingredient (API) Imipenem as monohydrate…………500mg
per unit Cilastatin as sodium...500mg
Pharmaceutical form of applied drug Powder for solution for injection
Pharmacotherapeutic Group of (API) Anti bacterial / dehydropeptidase inhibitor
specifications
status in reference regulatory authorities Primaxin injection (500mg/500mg) by M/s Merck, USFDA
Approved.
For generic drugs (me-too status) Cilapen 500mg injection by M/s Bosch, Reg. No. 048491
GMP status of the Finished product GMP certificate issued on 06/12/2019 on the basis of
manufacturer inspection conducted on 16/09/2019.
Dry powder injectable (Penicillin, Carbapenem) section is
approved.
Name and address of API manufacturer. M/s Aurobindo Pharma limited, Unit-V, Plot no. 68-70, 73-
91, 95, 96, 260, 261 IDA., Chemical zone, Pashmylaram,
Patancheru Mandal, Saga Reddy district, Telangana, India.
general properties, solubilities, physical form, manufacturers,
studies of drug substance and drug product is submitted.
Module-III (Drug Substance): The drug substance is sterile bulk mixture of Imipenem abd
cilastin in a ratio of 1:1.The firm as submitted detail of
process and controls, impurities, specifications, analytical
justification of specification, reference standard, container
closure system and stability studies of drug substance
Stability studies of Drug Substance  60 months real time stability data at 30°C ± 2°C / 65% ±
conditions, duration 5%RH of 03 batches
5%RH of 03 batches
Batches: EEC0821002, EEC0821003, EEC0821004
Module-III (Drug Product): Detail of manufacturers, description of manufacturing
procedures and its validation, batch analysis and justification
of specification, reference standard, container closure system
and stability studies of drug product is submitted.
Analytical method Th firm has submitted analytical method verification studies.
validation/verification Official monograph for the product is available in USP.
Comparative dissolution
profile/Pharmaceutical Equivalence

Manufacturer of API M/s Aurobindo Pharma limited, Unit-V, Plot no. 68-70, 73-91, 95, 96,
260, 261 IDA., Chemical zone, Pashmylaram, Patancheru Mandal,
Saga Reddy district, Telangana, India.
Copy of GMP certificate of API manufacturer is submitted.
API Lot No. 1605204528
Description of Pack
USP type I colorless glass vials
Frequency Accelerated: 0, 1, 2, 3, 4, 6 (Months)
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. V6001 V7001 V8001
Manufacturing Date 10/2016 08/2017 02/2018
No. of Batches 03
Reference of previous approval of applications with Not submitted.
Approval of API/ DML/GMP certificate of API Certificate No.
Documents for the procurement of API with ADC attested Invoice No. U05/17-18/73 dated 20th, July,
approval from DRAP (in case of import). 2017
Data of stability batches will be supported by The firm has submitted supported documents including
attested respective documents like chromatograms, chromatograms, raw data sheets, COAs summary sheets.
Compliance Record of HPLC software 21CFR & Not submitted

Record of Digital data logger for temperature and Not submitted
REQUEST OF EXEMPTION FROM ON SITE INSPECTION
S.# Query Response by the firm
1 The documents from the API manufacturer in the According to the firm’s response, “It was a
submitted dossier show that Imipenem as typographical error which is corrected from onward
monohydrate 500mg has been used in the as we are procuring the material as monohydrate and
manufacturing of blend of Imipenem and our calculations are entirely as per monohydrate
Cilastatin as well as the reference product contains material”.
Imipenem as monohydrate 500mg while However, earlier the firm has submitted that the
documents from finished product manufacturer material is received in either form Monohydrate or
show that Imipenem anhydrous 500mg is used, Anhydrous.
clarify.
2 Blend of 02 APIs is used for the manufacturing of According to firm “As the material is received in the
finished product, for such products potency blend form with ratio of 1:1 so the 100% material
adjustment becomes very critical because by contains 50% of Imipenem and 50% of Cilastatin.
adjusting the potency of one API would cause the Considering standard potency of both APIs equal to
actual potency of the other API to be changed. 50% (500mg) each, theoretical calculations are
Therefore, provide procedure for potency given in the following.
adjustment for the applied product. Imipenem:
Theoretical quantity= 500mg+2% = 510mg
Cilastatin:
Theoretical quantity= 500mg+2% = 510mg
Total quantity of blend= 510+510 = 1020mg per vial
3 Section 3.2.P.2.2.1 shall include detail of all the The firm has submitted the required data of
quality tests along with the results performed on pharmaceutical equivalence in relevant section by
the developed product against performing the quality tests against the comparator
innovator/reference/comparator product foe product Cilapen 500mg by M/s Bosch
establishing the pharmaceutical equivalence. Pharmaceuticals. The firm has stated that the
innovator’s product is not available in Pakistan.
4 Valid GMP certificate of API manufacturer is Copy of renewal letter of drug manufacturing
required. license of API manufacturer is submitted.
License No.:48/MD/AP/98/B/R
Valid till: 31/12/2021
5 Significant change has been observed in real time According to the reply of the firm has placed 3 more
stability testing of batch number V8001 in assay batches in the year 2018 wherein no significant
value of both Imipenem as well as Cilastatin, change has been observed, detail of which is given
justify. as under.
Real time: 30°C ± 2°C / 65% ± 5%RH of 03 batches
till 24 months
Accelerated: 40°C ± 2°C / 75% ± 5%RH of 03
batches till 06 months
Batch No. V8003 V8004 V8005
 The diluent mentioned in section 3.2.P.2.6 is Water for Injection while as per the available information
regarding innovator/reference product the contents of the vials must be reconstituted by adding approximately 10
mL of the appropriate diluent to the vial.
 List of appropriate diluents are as follows:
0.9% Sodium Chloride Injection
5% Dextrose Injection
5% Dextrose and 0.9% Sodium Chloride
5% Dextrose Injection with 0.225% or 0.45% saline solution
 The submitted testing method for analysis of drug product is different from the method described in USP
monograph in terms of standard preparation, assay calculation and formula.
 The test of pH in which the firm specifies that 1gram of sample should be dissolved 100ml of distilled
water, however USP specifies that reconstitute as directed in the labelling. The labelling of the innovator /
reference product does not recommend reconstitution in WFI.
Decision of 312th meeting:
Registration Board deliberated the case in detail and observed that the contract manufacturer has not performed
complete product development studies, the specifications adopted by the manufacturer throughout stability studies
were not according to USP. Accordingly, the Board deferred for the case for following submissions:
Scientific justification for your test of pH which specifies that “reconstitute the sample in 10ml WFI”, however
USP specifies that reconstitute as directed in the labelling and the labelling of the innovator / reference product
does not recommend reconstitution in WFI.
Scientific justification for having the method of sample solution preparation for the commercial batches which
is different from that specified in USP monograph.
Scientific justification for using an entirely different formula for calculation of assay results of commercial
batches from that specified in USP monograph.
Keeping in view the above, the Board decided that the submitted stability study data is not acceptable and directed
the manufacturer to either perform complete product development and stability studies or submit the
aforementioned data as per USP specifications and submit data accordingly. The Board further directed the
manufacturer to comply USP Specifications for already registered drug products.
Submission by the firm:
 The firm has submitted, “Imipenem & Cilastatin material is available and used in blend powder form for
injection. For potency adjustment, the lower potency API will be adjusted so the quantity of other API might
be slightly adjusted over the target value due to slight difference of potency of both API’s.
Calculations for potency adjustment:
Batch of blend: AB88390
Potency of Imipenem: 44.67%
Potency of Cilastatin: 47.25%
After considering both Imipenem & Cilastatin at 44.67%
For the applied product: Cilomen 500mg = 100 x 500 = 1119.319 mg/vial
44.67%
 “We would like to inform you that, we had tested the product according to USP but unfortunately due to some
misunderstanding the different formula and concentration were used against USP. We have placed three new
batches for stability studies and test it according to USP in all aspects. Revised method and raw data sheets
with correct calculation has been attached for your reference”.
 The firm has stated, “for the applied product, we have used 10ml of 0.9% Sodium chloride for testing purpose
only’.
 The standard solutions have been run for Cilastatin and Imipenem separately for analysis of the sample.
 The chromatographic conditions include 50oC column temperature, 300mm×4.6mm with packing L1, flow
rate 2mL/min, wavelength 254nm, Injection volume 10uL. Detail of the tailing factor and theoretical plates
not provided by the firm.
 The firm has submitted the data of 03 batches detail of which is given as under;
Batch No. V1002 V1001 V0003
Batch Size 16000 18340 9000 vials
API Lot No. 9900680007E1 DBIMCNF002 AB88390
Attested Invoice no. 7000057843 dated
Not provided 7000053843 dated 30/09/2020
31/12/2020
Source of drug substance Sun Pharmaceutical Sun Pharmaceutical industries
ACS Doofar, Italy
industries Ltd., India Ltd., India
Frequency 0, 3 (months) 0, 3 (months) 0, 3 (months)
 The formula used for calculation by the firm is given in the following along with complete calculation of a
sample.
Decision of 313th meeting of Registration Board: Registration Board deliberated that the commercial batches
manufactured by the manufacturer i.e. Stallion Pharmaceuticals was not developed and tested as per the USP
monograph. Keeping in view the USP monograph, public assessment report of the innovator product and the data
submitted by the firm, the Board decided to defer the case and advised the manufacturer to perform product
development studies keeping in view the innovator product and product testing and stability studies by complying
USP monograph and submit data upon completion of 6 months stability studies.
Submission by the firm: Firm has now submitted data of newly manufactured batches in which source of drug
substance has been changed to ACS Dobfar Italy. PE studies have been conducted against cilapen injection of
Bosch pharma and three batches having batch size of 3530 vials manufactured in April 2022 has been submitted.
Manufacturer of API M/s ACS Dobfar S.p.A. Viale Addetta, 2s/12-3/5 Tribiano Milano
Italy.
API Lot No. 0069E1
Description of Pack
glass vials
Frequency Accelerated: 0, 1, 3, 6 (Months)
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. V2001 V2002 V2003
No. of Batches 03
Reference of previous approval of applications with NA
Approval of API/ DML/GMP certificate of API Certificate No. IT-API/87/H/2022 issued by Italian medicine
manufacturer issued by concerned regulatory agency on the basis of inspection dated 03-12-2021.
Documents for the procurement of API with Firm has submitted clearance certificate dated 17-03-2022
approval from DRAP (in case of import). for import of 12Kg imipenem and cilastatin sodium sterile.
Data of stability batches will be supported by The firm has submitted supported documents including
attested respective documents like chromatograms, chromatograms, raw data sheets, COAs summary sheets.
Compliance Record of HPLC software 21CFR & Submitted by the firm

Record of Digital data logger for temperature and Submitted by the firm
Remarks of the evaluator:
 Significant change i.e. more than 5% change in assay from initial value has bee observed in accelerated
stability study for batch V2003.
Decision: Registration Board considering the submitted data of long term stability studies till 24 month time
point decided to approve the applied application.
 The manufacturer shall apply for post registration variation for the same formulation registered in
the name of the firm as well as all contract manufactured products.
 The Board further decided that product specific and capacity assessment inspection shall be carried
out for the instant product by a panel to be constituted by Chairman Registration Board.
Registration Board further authorized its Chairman for issuance of registration letter upon
consideration of satisfactory product specific and capacity assessment of manufacturing and testing
facility of the firm.
Case No. 03 Cases of Form 5
a. New cases
392. Name and address of M/s High-Q Pharmaceuticals B-64, KDA, Scheme No. 1,
manufacturer / Applicant Main Karsaz Road, Karachi, Pakistan
By
M/s English Pharmaceuticals Industries. Link Kattar
Brand Name +Dosage Form + Carbifer 50mg/ml Injection/Infusion
Strength
Composition Each 1ml ampoule Contains:
Iron As Ferric Carboxymaltose…50mg
Diary No. Date of R& I & fee Dy No. 27983: 16-08-2018
PKR 50,000/-: 16-08-2018
Pharmacological Group Iron preparations
Type of Form Form 5
Finished Product Specification Firm has claimed in house specifications
Pack size & Demanded Price 1ml: As per SRO
Approval status of product in USFDA Approved
Reference Regulatory Authorities.
Me-too status Bio-Maltose Injection by Bio-Lab
GMP status GMP certificate of M/s English Pharmaceutical Industries
Lahore valid till 13.07.2024 is submitted
Remarks of the Evaluator. 
 Firm shall submit 7,500/- fee for revision of specifications as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021.
By
Brand Name +Dosage Form + Carbifer 100mg/2ml Injection/Infusion
Strength
Composition Each 2ml vial Contains:
PKR 50,000/-: 16-08-2018
Type of Form Form 5
Approval status of product in Ferinject 50 mg iron/mL solution for injection/infusion. (2ml
Reference Regulatory Authorities. vial) MHRA Approved.
Me-too status Could not be confirmed
Remarks of the Evaluator.  Me-too status could not be confirmed
Decision: Deferred for evidence of applied formulation/drug in 2ml fill volume already
approved by DRAP (generic / me-too status) alongwith registration number, brand name
and name of firm. The Board further decided that the applicant shall submit the response
within 1 month after publication of the minutes, .
By
Brand Name +Dosage Form + Carbifer 500mg/10ml Injection/Infusion
Strength
Composition Each 10ml Vial Contains:
PKR 50,000/-: 16-08-2018
Type of Form Form 5
Pack size & Demanded Price 10ml vial: As per SRO
Me-too status Markferi 500mg/10ml Injection by Welmark
 Firm shall submit 7,500/- fee for revision of specifications as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021.
395. Name and address of M/s Alen Pharmaceuticals Pvt Ltd. 138-Nowshera
manufacturer / Applicant Industrial, Risalpur, KPK
By
M/s Nicholas Pharmaceuticals. Plot # 34, St. # SS-02,
National Industrial Zone, Rawat, Islamabad
Brand Name +Dosage Form + Ncopenem 500mg IV Injection
Strength
Composition Each Vial Contains:
Meropenem As Trihydrate…..…500mg
(Blended with Anhydrous Sodium Carbonate)
PKR 50,000/-: 23-11-2018
Pharmacological Group Carbapenems
Type of Form Form 5
Finished Product Specification USP
Me-too status Meronem injection by Pfizer
GMP status GMP certificate of M/s Nicholas Pharmaceuticals issued on
the basis of inspection dated 07.04.2021 is submitted
Decision: Approved.
By
Brand Name +Dosage Form + Ncopenem 1g IV Injection
Strength
Meropenem As Trihydrate…..…1g
(Blended with Anhydrous Sodium Carbonate)
PKR 50,000/-: 23-11-2018
Type of Form Form 5
Me-too status Meronem injection by Pfizer
Decision: Approved.
By
Brand Name +Dosage Form + Cilasten 500mg IV Injection
Strength
Each Vial Contains:
Imipenem as monohydrate…500mg
PKR 50,000/-: 23-11-2018
Type of Form Form 5
Me-too status Tienam injection by OBS
Decision: Approved.
b. Deferred cases
398. Name and address of M/s. Highnoon Laboratories Limited, 17.5Km, Multan
Applicant Road, Lahore
Detail of Drug Sale License Address: M/s. Highnoon Laboratories Limited, 17.5Km,
Multan Road, Lahore
Status: Valid
Name and address of M/s. Engelhard Arzneimittel GmbH & Co. KG, Hersbergstr. 3,
manufacturer 61138 Niederdorfelden, Germany
Name and address of marketing M/s. Engelhard Arzneimittel GmbH & Co. KG, Hersbergstr. 3,
authorization holder 61138 Niederdorfelden, Germany
Name of exporting country Germany
Type of Form Form 5-A
Diary No. & Date of R& I Dy. No.5882 Dated 13/06/2017
Fee including differential fee Rs. 50,000/- Dated 06/06/2017
Brand Name +Dosage Form + Tyrosur Powder
Strength
Composition Each gram of powder contains:
Tyrothricin………………1.0mg
Finished Product Specification In House`
Pharmacological Group Antibacterial
Shelf life 3 years
Demanded Price Not provided
Pack size 5gm, 20gm
International availability Available in Germany as per CoPP
Detail of certificates attached  Original legalized CoPP is attached (Certificate no.
DeLP24) certified by Regierungsprasidium Darmstadt
issued on 07/12/2016 confirms the free sale of the product
in exporting country. The facilities and operations conform
to GMP as recommended by World Health Organization.
Remarks of the Evaluator. The firm has claimed In-House manufacturing specifications
and the product is not present in USP/BP.
Decision of 274th meeting of RB: Deferred for confirmation of the drug whether it falls under the
category of pharmaceutical or Biological.
Submission by the firm: Firm has submitted that Tyrothricin is an EMA approved dmg and is
available worldwide but there is no even single brand of this drug is available in Pakistan but
registration ofTyrosur Powder and Tyrosur Gel is pending from a long time.
Decision of 330th meeting: Registration Board referred the case to Expert Working Group
for the review of “Human Formulations of Pharmaceutical Drug Products” .
399. Name and address of M/s. Highnoon Laboratories Limited, 17.5Km, Multan
Detail of Drug Sale License Address: M/s. Highnoon Laboratories Limited, 17.5Km,
Multan Road, Lahore
Status: Valid
Name and address of M/s. Engelhard Arzneimittel GmbH & Co. KG, Germany
manufacturer
Name and address of marketing M/s. Engelhard Arzneimittel GmbH & Co. KG, Germany
authorization holder
Name of exporting country Germany
Diary No. & Date of R& I Dy. No.5881 Dated 13/06/2017
Fee including differential fee Rs. 50,000/- Dated 06/06/2017
Brand Name +Dosage Form + Tyrosur Gel
Strength
Composition Each gram of gel contains:
Tyrothricin………………1.0mg
Finished Product Specification Not present in USP/BP
Shelf life 3 years
Demanded Price Not provided
Pack size 5gm, 15gm, 25gm
International availability Available in Germany as per CoPP
Detail of certificates attached  Copy of CoPP is attached (Certificate no. DeLP23) certified
by Regierungsprasidium Darmstadt issued on 07/12/2016
confirms the free sale of the product in exporting country.
The facilities and operations conform to GMP as
recommended by World Health Organization.
Remarks of the Evaluator. The firm has claimed In-House manufacturing specifications
and the product is not present in USP/BP.
th
Decision of 274 meeting of RB: Deferred for confirmation of the drug whether it falls under the
category of pharmaceutical or Biological.
Submission by the firm: Firm has submitted that Tyrothricin is an EMA approved dmg and is
available worldwide but there is no even single brand of this drug is available in Pakistan but
registration ofTyrosur Powder and Tyrosur Gel is pending from a long time.
Decision of 330th meeting: Registration Board referred the case to Expert Working Group
for the review of “Human Formulations of Pharmaceutical Drug Products” .
Case No. 04 Miscellaneous cases
M/s Gene-Tech Laboratories, Karachi has submitted the following application
Sr. No Brand Name and composition Fee details Dy No

400. Hyal Forte PKR 100,000 dated 24- Dy No. 10553, 06-04-
Each prefilled syringe (2ml) contains: 03-03-2021 2021
Sodium hyaluronate…..20mg
The application was initially submitted in BE&R Division, later on the application was forwarded to
PE&R Division for confirmation whether the applied product falls under the definition of drugs or
otherwise and for confirmation of source of the drug substance whether pharmaceutical or biological.
Decision: Registration Board deliberated the matter in detail and directed Pharmaceutical Evaluation
Cell (PEC) to evaluate the complete application and present the detailed evaluation report in the
forthcoming meeting.
M/s Mission Pharmacuticals, Karachi
M/s Mission Pharmaceuticals Karachi has informed that they have applied double dossiers of following
products by mistake. They have applied for these products on 07-03-2019 while they were already
registered.
Sr. No Brand Name and composition Fee details Approved in RB

meeting
401. Elvox Tablet 250mg Dy No. 15135: 07-03-2019 327
Each Film Coated Tablet Contains: PKR 20,000/-: 06-03-2019
Levofloxacin Hemihydrate eq to
Levofloxacin Base…250mg
402. Elvox Tablet 500mg Dy No. 15146: 07-03-2019 327
Each Film Coated Tablet Contains: PKR 20,000/-: 06-03-2019
Levofloxacin Hemihydrate eq to
Levofloxacin Base…500mg
The above products are already registered with the firm vide letter dated 28-06-2022, having registration
number 112661 and 112662.
Now the firm has requested to cancel these products which were approved in 327 th meeting of Board.
Decision: Registration Board acceded the request of the firm and decided to cancel the approval of
following products granted in 327th meeting of Registration Board.
 Elvox Tablet 250mg

 Elvox Tablet 500mg
Agenda of Evaluator PEC-IV
Agenda of Evaluator PEC-IV
Case no. 01 Registration applications for local manufacturing of (Human) drugs

a. New cases
403. Name, address of Applicant / Marketing M/s Wilson's Pharmaceuticals.

Authorization Holder 387-388, I-9/3, Industrial Area, Islamabad
Name, address of Manufacturing site. M/s Wilson's Pharmaceuticals.
387-388, I-9, Industrial Area, Islamabad
☐ Importer
giver)
☐ Export sale
Details of fee submitted PKR 30,000/-: Deposit slip # 33800594
The proposed proprietary name / brand name Wilzon 5mg Tablet
Pharmaceutical ingredient (API) per unit Metolazone…..…5mg
Pharmaceutical form of applied drug Green colored Oval shaped tablets.
Pharmacotherapeutic Group of (API) (Diuretic/Saluretic/antihypertensive drug of the
quinazoline class)
Reference to Finished product specifications USP Specs.
The status in reference regulatory authorities
Zaroxolyn Tablet 5mg of (USFDA approved)
For generic drugs (me-too status) Metxone tablet 5mg of M/s Genome (Reg.#
090699)
GMP status of the Finished product manufacturer cGMP certificated on the basis of evaluation
conducted on 28-07-2022 and valid till 27-07-
2024.
Name and address of API manufacturer. M/s Centaur Pharmaceuticals Pvt Limited.
Plot No. 75,76 & 76/1 Chikhloli MIDC
Ambernath (W) Dist. Thane 421 501
Maharashtra India.
solubility’s, physical form, manufacturers,
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 Metolazone is present in
USP pharmacopeia. The firm has submitted
detail of nomenclature, structure, general
properties, solubility’s, physical form,
process and controls, tests for impurities,
specification, reference standard, container
closure system and stability studies of drug
substance
Real time: 30°C ± 2°C / 65% ± 5%RH for 36
months
months
Batches: (1503601P, 1503602P, 15036003PL1)
procedure and its verification studies, batch
stability studies of drug product.
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence have been
dissolution profile established against the comparator brand that is
‘Metxone tablet 5mg of M/s Genome, by
performing quality tests (Assay & Dissolution
and Disintegration time).
CDP has been performed against the
comparator brand that is ‘Metxone tablet 5mg
of M/s Genome in Acidic media (pH 1.2),
Acetate Buffer (pH 4.5) & Phosphate Buffer
(pH 6.8) and in Sodium phosphate buffer (pH
7.5) . The f2 values are in the acceptable range.
Analytical method validation/verification of Method Verification studies have submitted
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. 1803605P
Description of Pack
Alu-Alu
Batch No. Trial# 02 Trial# 03 Trial# 04
Batch Size 1500 Tablets 1500 Tablets 1500 Tablets
Manufacturing Date 11.2019 11.2019 11.2019
Date of Initiation 11.2020 11.2020 11.2020
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of DML License No. 25-KD/1149 issued
manufacturer issued by concerned regulatory by Food and Drug Administration Maharashtra
authority of country of origin. India. Dated: 26-08-2018 and valid till 22-09-
2023.
3. Documents for the procurement of API with Firm has submitted copy of, form 3 form 6, form
approval from DRAP (in case of import). 7 and clearance certificate of mentioning invoice
(invoice# CP/EXP/C/030/19-20) dated 12-04-
2019 cleared by DRAP Islamabad office dated
25-06-2019 specifying import of Metolozone
0.135Kg (Batch# 1803605P).
chromatograms,
S.No Section Shortcomings Communicated Reply
1. 3.2.S.4.1 Copies of the Drug substance Copies of the Drug substance specifications of
specifications of the Drug the Drug substance /Active Pharmaceutical
substance /Active Ingredient by Drug Product manufacturer are
Pharmaceutical Ingredient by submitted.
Drug Product manufacturer is
required.
2. 3.2.S.4.2 Analytical procedures used for Analytical procedures used for routine testing of
routine testing of the Drug the Drug substance /Active Pharmaceutical
substance /Active Ingredient by Drug Product manufacturer are
Pharmaceutical Ingredient by submitted.
required.
3. 3.2.S.4.3 Analytical Method Verification Analytical Method Verification studies including
studies including specificity, specificity, accuracy and repeatability (method
accuracy and repeatability precision) performed by the Drug Product
(method precision) performed manufacturer drug substance is submitted
by the Drug Product
manufacturer drug substance(s)
shall be submitted.
4. 3.2.P.5.1 You have not performed Uniformity of dosage unit by content uniformity
uniformity of dosage unit by submitted.
content uniformity, as
recommended by USP General
Chapter <905>. Justification
shall be submitted in this regard.
Decision: Approved.
b. Deferred cases
404. 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 Tramax 100mg SR Capsule
Composition Each Sustained Release Capsule Contains:
Tramadol Hcl…100mg
Diary No. Date of R& I & fee Dy.No. 41495 dated 07-12-2018 Rs.20,000/- 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
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 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 Immediate Extended
release release
100 mg 25 mg 75 mg
Previous Decision (M-322): Deferred for review of formulation against the innovator product.
Reply by firm: We want to inform you that we had applied for Tramadol HCl 100mg as “Tablet”.
There was typographical error in the last reply sent in response to letter number F.1-1/2019/PEC-
DRAP (AD PEC-IV) dated: 7th September, 2022. R & I copy of product is attached for reference.
We are also applying for the change in the label claim of the product
Name of Drug with Applied Name of Drug with Proposed Fee for change in label claim
label claim label claim
Tramax 100mg SR Tablet Tramax 100mg SR Tablet Deposit slip No#
Each Sustained Release Each Extended Release Film 50754384014
Tablet Contains: Coated Tablet Contains: Rs:7500/-
Tramadol Hcl…100mg Tramadol Hcl…100mg Dated: 23-01-2023
Approval status of product in ULTRAM ER of USFDA
Remarks: Film coating is not mentioned in ULTRAM ER
Master formula and manufacturing method is not submitted.
Previous Decision (M-326): Registration Board deferred the case for submission of Master
formula and manufacturing method.
Evaluation by PEC: Master formula and manufacturing method as per Innovator is submitted by
firm
Decision: Approved as per following label claim:
“Tramax 100mg SR Tablet
Each Extended Release Film Coated Tablet Contains:
Tramadol HCl…100mg”
The firm shall submit fee of Rs. 30,000/- for correction/pre-approval change in product label
claim as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021, before issuance of
registration letter.
Case no. 02 Registration applications of newly granted DML or New section (Human)
a. New DML
New case
M/s Oncogen Pharma Private Limited . (New DML)
CLB in its 287th meeting held on 24th June 2022 has considered and approved the grant of Drug
Manufacturing License by way of formulation with following Two (02) sections to M/s Oncogen Pharma
Private Limited.
1) Tablet ( Oncology )
2) Capsule (Oncology)
Sr. No Section Molecules for Products for

consideration in 329th consideration in 329th
meeting meeting
1 Tablet ( Oncology ) 01 01
405. Name, address of Applicant / Marketing M/s Oncogen Pharma Private Limited.
Authorization Holder Plot No # WH 26 and 27-A3, Korangi Creek
Industrial Park Karachi.
Name, address of Manufacturing site. M/s Oncogen Pharma Private Limited.
Plot No # WH 26 and 27-A3, Korangi Creek
Industrial Park Karachi.
☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand name Imaver Tablet 100mg
Pharmaceutical ingredient (API) per unit Imatinib Mesylate Ph. Eur. equivalent to Imatinib
………….…. 100 mg.
Pharmaceutical form of applied drug Dark yellow to brownish orange color, round
shape film coated tablet, debossing '100' on one
side and plain on other side,
Pharmacotherapeutic Group of (API) Antineoplastic (Protein Kinase Inhibitors)
L01EA01
Proposed Pack size 1 x 10’s (10’s)
3 x 10’s (30’s)
6 x 10’s (60’s)
12 x 10’s (120’s)
Proposed unit price 1 x 10’s (10’s) = 17,000/-
3 x 10’s (30’s) = 51,000/-
6 x 10’s (60’s) = 102,000/-
12 x 10’s (120’s) = 204,000/-
The status in reference regulatory authorities Gleevec Tablets 100mg by M/s Novartis
Pharmaceuticals corporation, New Jersey USA
USFDA Approved.
For generic drugs (me-too status) Glivec Tablets 100mg by M/s Novartis
Pharmaceuticals Pakistan.
(Reg. No.: 033196)
GMP status of the Finished product manufacturer Last DML Inspection dated 08-06-2022
concludes as ‘GOOD’ based on designed and
established at an acceptable level of compliance
of GMP requirements.
Tablet (Anti-cancer) and Capsule (Anti-cancer)
sections were approved.
Name and address of API manufacturer. M/s CDYMAX (India) Pharma Private Limited
(Formerly known as Acebright (India) Pharma
Pvt. Ltd.)
116/117, KIDAB, Indl. Area, Jigani 2nd Phase,
Jigani, Bangalore-560 105 India.
drug substance and drug product is submitted.
Module III (Drug Substance) Official monograph of Imatinib Mesylate is
available in European Pharmacopeia. Firm has
submitted detail of nomenclature, structure,
general properties, solubility, physical form,
analytical procedures and its verification, batch
Real time: 30°C±2°C/75±5%RH for 18 months
Accelerated: 40°C±2°C/75±5%RH for 6 months
Batches: (IMBE21001, IMBE21002,
IMBE21003)
procedure and its verification studies, batch
dissolution profile established against innovator’s product Glivec
100mg Tablet, Batch LM8549 by Novartis
Pharmaceuticals Germany by performing quality
tests (Appearance, Assay, Dissolution and
Impurities).
CDP has been performed against the innovator’s
product that is Glivec 100mg Tablet Batch
LM8549 by Novartis Pharmaceuticals Germany,
in Acidic medium (pH 1.2), Acetate Buffer (pH
4.5) & Phosphate Buffer (pH 6.8).
Analytical method validation/verification of Method Verification studies have submitted
product including system suitability, linearity, range,
accuracy, precision, specificity and stability of
solution.
Manufacturer of API M/s CDYMAX (India) Pharma Private Limited (Formerly known as
Acebright (India) Pharma Pvt. Ltd.) 116/117, KIDAB, Indl. Area, Jigani 2nd
Phase, Jigani, Bangalore-560 105 India.
API Lot No. IMBE21001 and IMBE21002
Description of Pack
Alu-Alu blister packed in unit carton (10’s, 30’s, 60’s and 120’s)
Frequency M/s CDYMAX (India) Pharma Private Limited (Formerly known as
Acebright (India) Pharma Pvt. Ltd.) 116/117, KIDAB, Indl. Area, Jigani 2nd
Phase, Jigani, Bangalore-560 105 India.
Batch No. 001NS04 001NS05 001NS06
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of Drug Manufacturing
manufacturer issued by concerned regulatory License (DML) License no. KTK/25/506/2005
authority of country of origin. issued by Govt. of Karnataka, Drug control
department, India. (valid till 14-07-2025).
3. Documents for the procurement of API with Form 6 was issued to firm bearing no. K-
approval from DRAP (in case of import). 734956897361 issue date: 21-07-2022 to import
the Imatinib Mesylate 2.7 Kg from CDYMAX
(India) Pharma Private Limited (Formerly known
as Acebright (India) Pharma Pvt. Ltd.) 116/117,
KIDAB, Indl. Area, Jigani 2nd Phase, Jigani,
Bangalore-560 105 India for manufacturing of
Trial and stability batches
4. Data of stability batches will be supported by Firm has submitted data of stability batches along
attested respective documents like with batch manufacturing record, analytical record
chromatograms, and attested documents like chromatograms, Raw
Raw data sheets, COA, summary data sheets etc. data sheets, COA, summary data sheets etc.
5. Compliance Record of HPLC software 21CFR & Firm has submitted compliance certificate of
audit trail reports on product testing HPLC software and audit trail reports on product
testing.
6. Record of Digital data logger for temperature and Firm has submitted record of digital data logger
humidity monitoring of stability chambers (real for temperature & humidity monitoring of stability
time and accelerated) chambers (real time and accelerated)
1. 3.2.S.4.4 Which Polymorphic form was This is to inform you that the polymorphic form
chosen for the manufacturing of of imatinib Mesylate used by Oncogen Pharma is
the finished product. 13-beta form and the same polymorphic form is
used by innovator in Gleevec 100mg tablet
(Novartis). We are enclosing the COA of drug
substance manufacturer confirming the
polymorphic form and Innovator product
reference document.
2. 3.2.P.5.1 US FDA review document of This is to inform you that our product
the Innovator product, specifies specification is in-house and not available in
the dissolution limit as “NLT Q any pharmacopeia. Therefore, dissolution
in 15 minutes” whereas sampling time point was set as 20mins. We have
submitted specifications declare performed Comparative dissolution profile
the dissolution limits as “NLT (CDP) which shows that tablets were dissolved
85% in 20 minutes” more than 85% within 15 minutes in acidic
medium such as 0.IN HCI. We hereby commit
that we will revise the dissolution sampling time
on commercial specifications of our product in
line with innovator specifications. CDP data is
attached.
Decision: Approved. Firm shall submit revised drug product specifications with sampling time of 15
minutes for dissolution test along with 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 07-05-2021, before issuance of
M/s Swera Pharmaceuticals. (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 six (06) sections to M/s Swera
Pharmaceuticals
1 Tablet(General) 4 Cream/ Gel (General)
2 Capsule (General) 5 Lotion Section (General)
3 Sachet (General) 6 Dry Powder Injection (General)
Tablet (General)
01 Molecules/ 02 Products
406. Name, address of Applicant / Marketing M/s Swera Pharmaceuticals.
Name, address of Manufacturing site. M/s Swera Pharmaceuticals.
Plot No. 27, Street No. S-4 National Industrial
☐ Importer
GMP status of the firm New DML letter issued dated; 16-09-2021
Evidence of approval of manufacturing facility New DML letter issued dated; 16-09-2021 in
which Tablet (General) section mentioned.
☐ Export sale
Details of fee submitted PKR 30,000/- Deposit slip# 6071839530
The proposed proprietary name / brand name Terbiera 125mg Tablet
Pharmaceutical ingredient (API) per unit Terbinafine as HCl…… 125mg
Pharmacotherapeutic Group of (API) Antifungal
Pharmaceutical form of applied drug White to off white colored uncoated tablet
The status in reference regulatory authorities LAMISIL 125mg Tablet by Novartis
Pharmaceuticals of (TGA Approved)
For generic drugs (me-too status) LAMISIL 125mg Tablet by M/s Novartis Pharma
(Pakistan) Ltd Reg #013208
Name and address of API manufacturer. M/s Saptagir Laboratories
Address: Sy.No.Parts of 27, 46 %0 to 56
Ananthasagar (Vill), Chegunta (Mandal) Medak
(district, Telegana, India.
properties, solubility, physical form,
drug substance and drug product.
drug substance.
Stability Studies of Drug Substance Stability study conditions:
(Conditions & duration of Stability studies) Real time: 30°C ± 2°C / 65% ± 5%RH for 36
months
months
Batches: (TH0131216, TH0141216,
TH0151216)
Module-III Drug Product: Official monograph of Terbinafine HCL is present
in BP. Firm has submitted data of drug product
including its description, composition,
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 Comparative Pharmaceutical Equivalence have been
Dissolution Profile established against the ‘Lamisil tablet 125mg of
M/s Novartis pharma, by performing quality tests
(Identification, weight variation, disintegration,
Assay & Dissolution).
CDP has been performed against the ‘Lamisil
tablet 125mg of M/s Novartis pharma, in Acidic
media (pH 1.2), Acetate Buffer (pH 4.5) &
Phosphate Buffer (pH 6.8) and in Sodium
phosphate buffer (pH 7.5) . The f2 values are in
the acceptable range.
product.
Manufacturer of API M/s Saptagir Laboratories
Address: Sy.No.Parts of 27, 46 %0 to 56 Ananthasagar (Vill), Chegunta
(Mandal) Medak (district, Telegana, India.
API Lot No. TH0010122
Description of Pack
Alu-alu Blister
Batch No. RD-T007 RD-T008 RD-T009
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP Certificate
manufacturer issued by concerned regulatory (No.L.DIS. No.111050/TS/2023 dated 21-02-2023
authority of country of origin. issued by Drugs Control Administration
Government of Telegana India. Valid till 20-02-
2024
3. Documents for the procurement of API with Firm has submitted copy of form 5 and clearance
approval from DRAP (in case of import). certificate no # E-1226082941489 , dated;21-05-
2022 specify commercial invoice 2223/SL/009 on
20-04-2022 specifying 1Kg of Terbinafine batch #
TH0010122.
attested respective documents like testing.
data sheets etc.
5. Compliance Record of HPLC software 21CFR & Not 21CFR compliant
audit trail reports on product testin
S.No Section Shortcoming communicated Reply
1. 1.6.5 Valid Approval of API/ Valid Approval of API/ DML/GMP
DML/GMP certificate of API certificate of API manufacturer issued by
manufacturer issued by concerned concerned regulatory authority of country of
regulatory authority of country of origin submitted.
origin.
2. 3.2.P.3.5 Process validation protocol does Process validation protocol including
not include sampling plan. sampling plan submitted.
3. 3.2.P.5.2 Submit complete standard and Complete standard and sample preparation
sample preparation method in method in assay method submitted.
assay method
4. 3.2.P.8 Submit COA’s of all time points. COA’s of all time points submitted.
Decision: Approved.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Terbiera 250mg Tablet
Pharmaceutical ingredient (API) per unit Terbinafine as HCl…… 250mg
Pharmaceutical form of applied drug White to off white colored uncoated tablet
The status in reference regulatory authorities LAMISIL 250mg Tablet by Novartis
Pharmaceuticals of (USFDA Approved)
For generic drugs (me-too status) LAMISIL 250mg Tablet by M/s Novartis Pharma
(Pakistan) Ltd Reg #013209
drug substance.
months
months
Batches: (TH0131216, TH0141216,
TH0151216)
Module-III Drug Product: Official monograph of Terbinafine HCL is present
in BP. Firm has submitted data of drug product
manufacturing process and process control,
procedures, validation of analytical procedures,
batch analysis, justification of specifications,
Dissolution Profile established against the ‘Lamisil tablet 250mg of
M/s Novartis pharma, by performing quality tests
(Identification, weight variation, disintegration,
Assay & Dissolution).
CDP has been performed against the ‘Lamisil
tablet 250mg of M/s Novartis pharma, in Acidic
product.
Description of Pack
Alu-alu Blister
Batch No. RD-T010 RD-T011 RD-T012
No. of Batches 03
2024
TH0010122.
data sheets etc.
DML/GMP certificate of API certificate of API manufacturer issued by
manufacturer issued by concerned concerned regulatory authority of country of
regulatory authority of country of origin submitted.
origin.
3. 3.2.P.5.2 Submit complete standard and Complete standard and sample preparation
sample preparation method in method in assay method submitted.
assay method
4. 3.2.P.8 Submit COA’s of all time points. COA’s of all time points submitted.
Decision: Approved.
Cream/ Gel (General)
01 Molecule/ 01 product
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Terbiera 10g Cream
Strength / concentration of drug of Active Each gram cream contains:
Pharmaceutical ingredient (API) per unit Terbinafine as HCl……10mg
Pharmaceutical form of applied drug White to off white semisolid filled in Aluminum
tube
Reference to Finished product specifications JP
Proposed Pack size 1 x 10gm Tube
The status in reference regulatory authorities LAMISIL 1% w/w Cream by GlaxoSmithKline
Consumer Healthcare of (MHRA Approved)
For generic drugs (me-too status) LAMISIL 1% w/w Cream by M/s
GlaxoSmithKline Consumer Health Care Pakistan
Ltd Reg #084005
Module-III Drug Substance: Official monograph of Terbinafine HCL is present
in BP. Firm has submitted detailed drug substance
drug substance.
months
months
Batches: (TH0131216, TH0141216,
TH0151216)
justification of specifications, reference standard
or materials, container closure system and
stability.
Dissolution Profile established against the ‘Lamisil cream 1% of M/s
Glaxo smith Klien, by performing quality tests
(Identification, weight variation, Assay).
product.

Description of Pack
Aluminium Tube filled with cream
Batch No. RD-TC001 RD-TC002 RD-TC003
Batch Size 300 Tubes 300 Tubes 300 Tubes
No. of Batches 03
2024
TH0010122.
data sheets etc.
DML/GMP certificate of API certificate of API manufacturer issued
manufacturer issued by concerned by concerned regulatory authority of
regulatory authority of country of country of origin submitted.
origin.
3. 3.2.P.8  Submit COA’s of all time COA’s of all time points submitted.
points
 Compliance Record of HPLC
software 21CFR & audit trail
reports on product testing
Decision: Approved.
M/s Pine Pharmaceuticals. (New DML)
CLB in its 285th meeting held on 17th and 18th March 2022 has considered and approved the grant of
Drug Manufacturing License by way of formulation with following three (03) sections to M/s Pine
Pharmaceuticals
1. Tablet (General)
2. Capsule (General)
3. Cream Ointment (General)
Accordingly, firm has applied for following products for consideration by Drug Registration Board
Tablet (General)
409. Name, address of Applicant / Marketing M/s Pine Pharmaceuticals
Authorization Holder Rawat, Islamabad.
Name, address of Manufacturing site. M/s Pine Pharmaceuticals
Plot# 40,Street#S-6,National Industrial Zone,
Rawat, Islamabad.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Terbipine 125mg tablet
Strength / concentration of drug of Active Each uncoated tablet contains:
Pharmaceutical ingredient (API) per unit Terbinafine as HCl …….125mg
Pharmaceutical form of applied drug White color, round, uncoated tablets
The status in reference regulatory authorities Terbinafine 125mg tablet MHRA/TGA Approved.
Pakistan, Reg. No. 013208
Name and address of API manufacturer. M/s Tagoor Laboratories Pvt. Ltd., (Unit-1), Sy
No 29, Tupakulagudem (V), Pochavaram
Panchayat, Tallapudi (M), West Godavari, Dis-
534341, A.P, India
Module-III Drug Substance: Official monograph of Terbinafine HCl is present
in USP. Firm has submitted detailed drug
drug substance.
months
months
Batches: (TBH0131216, TBH0141216,
TBH0151216)
stability.
Dissolution Profile established against the brand leader that is Lamisil
125mg tablet by M/S Novartis Pharama Pakistan
by performing quality tests (Identification, Assay,
Dissolution, Uniformity of dosage form).
CDP has been performed against the same brand
that is Lamasil 125mg tablet by M/S Novartis
Pharma Pakistan 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.
product.
Manufacturer of API M/s Tagoor Laboratories Pvt. Ltd., (Unit-1), Sy No 29, Tupakulagudem
(V), Pochavaram Panchayat, Tallapudi (M), West Godavari, Dis-534341,
A.P, India
API Lot No. TBH-0020421
Description of Pack
Batch No. TB01 TB02 TB03
Batch Size 2,000 tabs 2,000 tabs 2,000 tabs
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP Certificate (WC-
manufacturer issued by concerned regulatory 0494) dated 23-02-2022 issued by Central Drugs
authority of country of origin. Standard Control Organization India. Valid till
26/02/2024.
3. Documents for the procurement of API with Firm has submitted copy of Commercial Invoice #
approval from DRAP (in case of import). EXP/034/21-22, dated; 02-08-2021 specify
approved by DRAP Islamabad office date: 08-09-
2021 specifying 50Kg of Terbinafine HCl batch #
TBH-0020421
data sheets etc.
5. Compliance Record of HPLC software 21CFR & Our HPLC system is not 21 CFR compliant.
1. 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) performed
(method precision) performed by by the Drug Product manufacturer for drug
the Drug Product manufacturer for substance is submitted.
drug substance(s) shall be
submitted.
2. 3.2.P.6 COA of primary / secondary COA of primary / secondary reference
reference standard including standard including source and lot number
source and lot number of shall be
provided
3. 3.2.P.8  Documents for the  Documents for the procurement of API
procurement of API with with approval from DRAP submitted.
approval from DRAP readable  An agreement of API’s Loan between
form. Pine pharmaceuticals and panacea
 Borrowing of API is letter is pharmaceuticals submitted.
attached but did not specify  COA’s of all time points for real and
from whom API is borrowed. Accelerated stability studies submitted.
 Submit COA’s of all time
points for real and Accelerated
stability studies.
Decision: Approved.
Rawat, Islamabad.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Terbipine 250mg tablet
Strength / concentration of drug of Active Each uncoated tablet contains:
Pharmaceutical ingredient (API) per unit Terbinafine as HCl …….250mg
Pharmaceutical form of applied drug White color, round, uncoated tablets
The status in reference regulatory authorities Terbinafine 250mg tablet MHRA/TGA Approved.
Pakistan, Reg. No. 013209
Name and address of API manufacturer. M/s Tagoor Laboratories Pvt. Ltd., (Unit-1), Sy
No 29, Tupakulagudem (V), Pochavaram
Panchayat, Tallapudi (M), West Godavari, Dis-
534341, A.P, India
Module-III Drug Substance: Official monograph of Terbinafine HCl is present
in USP. Firm has submitted detailed drug
drug substance.
months
months
Batches: (TBH0131216, TBH0141216,
TBH0151216)
stability.
Dissolution Profile established against the brand leader that is Lamisil
250mg tablet by M/S Novartis Pharama Pakistan
that is Lamasil 250mg tablet by M/S Novartis
Pharma Pakistan in Acid media (pH 1.0-1.2),
range.
product.
Manufacturer of API M/s Tagoor Laboratories Pvt. Ltd., (Unit-1), Sy No 29, Tupakulagudem
(V), Pochavaram Panchayat, Tallapudi (M), West Godavari, Dis-534341,
A.P, India
API Lot No. TBH-0020421
Description of Pack
Batch No. TB04 TB05 TB06
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP Certificate (WC-
manufacturer issued by concerned regulatory 0494) dated 23-02-2022 issued by Central Drugs
authority of country of origin. Standard Control Organization India. Valid till
26/02/2024.
3. Documents for the procurement of API with Firm has submitted copy of Commercial Invoice #
approval from DRAP (in case of import). EXP/034/21-22, dated; 02-08-2021 specify
2021 specifying 50Kg of Terbinafine HCl batch #
TBH-0020421
data sheets etc.
5. Compliance Record of HPLC software 21CFR & Our system is not 21 CFR compliant.
the Drug Product manufacturer for substance is submitted.
submitted.
reference standard including standard including source and lot number
source and lot number of shall be
provided
3. 3.2.P.8  Documents for the  Documents for the procurement of API
procurement of API with with approval from DRAP submitted.
approval from DRAP readable  An agreement of API’s Loan between
form. Pine pharmaceuticals and panacea
 Borrowing of API is letter is pharmaceuticals submitted.
attached but did not specify  COA’s of all time points for real and
from whom API is borrowed. Accelerated stability studies submitted.
 Submit COA’s of all time
points for real and Accelerated
stability studies.
Decision: Approved.
Rawat, Islamabad.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Ciprapine 5mg tablet
Pharmaceutical ingredient (API) per unit Escitalopram as Oxalate …….5mg
Pharmacotherapeutic Group of (API) Selective Serotonin Reuptake Inhibitors
[SSRI] (Anti-depressant)
Pharmaceutical form of applied drug White to off white, round, scored, film coated
tablets
The status in reference regulatory authorities Cipralex 5mg tablet by M/s Lundbeck Limited,
MHRA Approved.
For generic drugs (me-too status) Precipra 5mg Tablet by M/s Pfizer, Reg.
No.067361
Name and address of API manufacturer. M/s Shodana Laboratories Private Limited Plot No
24,25,26, Phase 1, Jeedimetla, Hyderabad-50055
Telangana India
Module-III Drug Substance: Official monograph of Escitalopram oxalate is
present in USP. Firm has submitted detailed drug
drug substance.
months
months
Batches: (DSNBC-2 17001, DSNBC-2 17002,
DSNBC-2 17003)
stability.
Dissolution Profile established against the brand leader that is Precipra
5mg tablet by Pfizer Pharma by performing quality
tests (Identification, Assay, Dissolution,
Uniformity of dosage form).
that is Precipra 5mg tablet by Pfizer Pharma 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.
product.
Manufacturer of API M/s Shodana Laboratories Private Limited Plot No 24,25,26, Phase 1,
Jeedimetla, Hyderabad-50055 Telangana India
API Lot No. EO-095/21
Description of Pack
Batch No. T01E T02E T03E
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP Certificate (L,
manufacturer issued by concerned regulatory Dis,No,86774/TS/2022) dated 25-05-2022 issued
authority of country of origin. by Drug control Administration Government of
Telangana India. Valid till 24/05/2023.
3. Documents for the procurement of API with A letter to additional director/Secretary written for
approval from DRAP (in case of import). borrowing of API was attached.
Firm has submitted copy of Commercial Invoice #
2021-22/EXP054, dated; 12-10-2022 specify
2021 specifying 5Kg of Escitalopram Oxalate
batch # EO-095/21. .(Panacea pharmaceuticals)
data sheets etc.
1. 1.6.5 Valid Drug Manufacturing Valid Drug Manufacturing License or Valid
License or Valid Good Good Manufacturing Practice (GMP)
Manufacturing Practice (GMP) certificate of the Drug Substance
certificate of the Drug Substance manufacturer issued by relevant regulatory
manufacturer issued by relevant authority of country of origin submitted.
regulatory authority of country of
origin.
2. 3.2.S.4.1 Copies of the Drug substance Copies of the Drug substance specifications
specifications both Drug both Drug substance & Drug Product
substance & Drug Product manufacturer are submitted.
manufacturer is required.
3. 3.2.s.4.2 Analytical procedures used for Analytical procedures used for routine
routine testing of the Drug testing of the Drug substance /Active
substance /Active Pharmaceutical Pharmaceutical Ingredient by both Drug
Ingredient by both Drug substance substance & Drug Product manufacturer are
& Drug Product manufacturer is submitted.
required.
the Drug Product manufacturer for substance(s) is submitted
submitted.
5. 3.2.P.2.2.1 Pharmaceutical equivalence and We have performed Pharmaceutical
CDP not performed against Equivalence and CDP against Brand Name
innovator product. Clarification is Pracepra 5mg Tablet by Pfizer which have
required. same formulation as per Innovator product.
6. 3.2.P.5.2 You have not performed We have performed uniformity of dosage
uniformity of dosage unit by units by content uniformity as recommended
content uniformity, as by USP General Chapter <905>.the
recommended by USP General uniformity test has included in COA’s.
Chapter <905>. Justification shall
be submitted in this regard.
reference citalopram citalopram Hydrobromide standard used for
Hydrobromide standard used for dissolution is submitted.
dissolution shall be provided
8. 3.2.P.8  Borrowing of API is letter is  An agreement of API’s Loan between
attached but did not specify Pine pharmaceuticals and panacea
from whom API is borrowed. pharmaceuticals submitted.
 Submit COA’s of all time  COA’s of all time points for real and
points for real and Accelerated Accelerated stability studies submitted.
stability studies.
Decision: Approved.
Rawat, Islamabad.
☐ Importer
☐ Export sale
tablets
MHRA Approved.
For generic drugs (me-too status) Cipralex 10mg Tablet by M/s Lundbeck Pakistan,
Reg. No. 028467
Telangana India
drug substance.
months
months
DSNBC-2 17003)
stability.
Dissolution Profile established against the brand leader that is
Cipralex 10mg tablet by M/s Lundbeck Pakistan
that is Cipralex 10mg tablet by M/s Lundbeck
Pakistan in Acid media (pH 1.0-1.2), Acetate
buffer (pH-4.5) & Phosphate Buffer (pH 6.8). The

product.
Description of Pack
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP Certificate (L,
manufacturer issued by concerned regulatory Dis, No,617/A2/201) dated 23-02-2022 issued by
authority of country of origin. Drug Control Administration Government of
data sheets etc.
origin.
required.
submitted.
5. 3.2.P.2.2.1 In CDP Cipralex Tablet and CDP has been performed against the brand
Lexapro Tablet both are that is Cipralex 10mg tablet by M/s
mentioned. Clarify which product Lundbeck Pakistan. Lexapro is a typoerror.
is used for CDP.
stability studies.
Decision: Approved.
Rawat, Islamabad.
☐ Importer
☐ Export sale
tablets
MHRA Approved.
For generic drugs (me-too status) Cipralex 20mg Tablet by M/s Lundbeck Pakistan,
Reg. No. 059035
Telangana India
drug substance.
months
months
DSNBC-2 17003)
stability.
Dissolution Profile established against the brand leader that is
Cipralex 20mg tablet by M/s Lundbeck Pakistan
that is Cipralex 20mg tablet by M/s Lundbeck
Pakistan in Acid media (pH 1.0-1.2), Acetate
buffer (pH-4.5) & Phosphate Buffer (pH 6.8). The
product.
Description of Pack
Batch Size 1500 tabs 1500 tabs 1500 tabs
No. of Batches 03
manufacturer issued by concerned regulatory (L,Dis,No,617/A2/201) dated 23-02-2022 issued
authority of country of origin. by Drug control Administration Government of
data sheets etc.
origin.
required.
submitted.
stability studies.
Decision: Approved.
Rawat, Islamabad.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Acepine 100mg Tablets
Pharmaceutical ingredient (API) per unit Aceclofenac …….100mg
Pharmacotherapeutic Group of (API) Anti-inflammatory and antirheumatic.
Pharmaceutical form of applied drug White color, round, film coated tablets
Reference to Finished product specifications Innovator specifications
The status in reference regulatory authorities Aceclofenac 100mg film caoted tablet MHRA/UK
Approved.
For generic drugs (me-too status) Airtal 100mg Tablet by M/s Highnoon
Laboratories Limited, Reg. No. 015398
Name and address of API manufacturer. M/s Aarti Drugs Limited, W-61,W-60(B), 71(B),
73(B), M.I.D.C. Tarapur District Thane,
Maharashta, INDIA
Module-III Drug Substance: Official monograph of Aceclofenac is present in
BP. Firm has submitted detailed drug substance
drug substance.
months
months
Batches: (ACE/1002/0004A, ACE/1002/0005A,
ACE/1002/0006A)
stability.
Dissolution Profile established against the brand leader that is Airtal
100mg tablet by M/s Highnoon Laboratories
Limited by performing quality tests
(Identification, Assay, Disintegration time,
that is Airtal 100mg tablet by M/s Highnoon
Laboratories Limited in Acid media (pH 1.0-1.2),
range
product.
Manufacturer of API M/s Aarti Drugs Limited, W-61,W-60(B), 71(B), 73(B), M.I.D.C. Tarapur
District Thane, Maharashta, INDIA
API Lot No. ACF/10100169
Description of Pack
Batch No. ACF01 ACF02 ACF03
No. of Batches 03
manufacturer issued by concerned regulatory (NEW-WHO-
authority of country of origin. GMP/CERT/KD/103280/2021/11/37083) dated
issued by Food and Drug Administration
Maharashtra India. Valid till 15/08/2024.
EXP/2240/20-21, dated; 10-11-2020 approved by
DRAP Islamabad office date: 08-12-2020
specifying 100Kg of Aceclofenac batch #
ACF/10100169.(Panacea pharmaceuticals)
data sheets etc.
origin.
3. 3.2.S.4.2 Analytical procedures used for Analytical procedures used for routine
required.
the Drug Product manufacturer substance(s) is submitted
for drug substance(s) shall be
submitted.
5. 3.2.P.8  Borrowing of API letter is  An agreement of API’s Loan between
stability studies.
Decision: Approved.
Rawat, Islamabad.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Ebaspine 10mg tablet
Pharmaceutical ingredient (API) per unit Ebastine …….10mg
Pharmacotherapeutic Group of (API) Antihistamine
Pharmaceutical form of applied drug White to off white, round, unscored, film coated
tablets
The status in reference regulatory authorities Ebastine 10 film coated tablets 10mg Netherland
Approved.
EBASTINE ARROW 10 mg film-coated tablets
ANSM Approved
For generic drugs (me-too status) Kestine 10mg tablets by M/s Highnoon
Name and address of API manufacturer. M/s Bal Pharma Unit 2 61-B, Bommasandra
Industrial Area Banglore-560099, Karantaka
State, India
Module-III Drug Substance: Official monograph of Ebastine is present in BP.
Firm has submitted detailed drug substance data
drug substance.
months
months
Batches: (EB/161005, EB/161006, EB/161007)
stability.
Dissolution Profile established against the brand leader that is Kestine
10mg tablet by M/S Highnoon Laboratories
limited Pakistan by performing quality tests
dosage form).
that is Kestine 10mg tablet by M/S Highnoon
Laboratories limited Pakistan 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.
product.
Manufacturer of API M/s Bal Pharma Unit 2 61-B, Bommasandra Industrial Area Banglore-
560099, Karantaka State, India
API Lot No. 5017072109004
Description of Pack
Batch No. TE01 TE02 TE03
No. of Batches 03
M02/2122/EXP/AEX/00219, dated; 27-10-2021
2021 specifying 10Kg of Ebastine batch #
5017072109004.(Panacea pharmaceuticals)
data sheets etc.
S.No Section Shortcoming communicated Response of the Firm
1. 1.6.5 Valid Drug Manufacturing License Valid Drug Manufacturing License or Valid
or Valid Good Manufacturing Good Manufacturing Practice (GMP)
Practice (GMP) certificate of the certificate of the Drug Substance
Drug Substance manufacturer issued manufacturer issued by relevant regulatory
by relevant regulatory authority of authority of country of origin submitted.
country of origin.
specifications both Drug substance & both Drug substance & Drug Product
Drug Product manufacturer is manufacturer are submitted.
required.
routine testing of the Drug substance testing of the Drug substance /Active
/Active Pharmaceutical Ingredient by Pharmaceutical Ingredient by both Drug
both Drug substance & Drug Product substance & Drug Product manufacturer are
manufacturer is required. submitted.
4. 3.2.P.5.2 You have not performed uniformity Analytical Method Verification studies
of dosage unit by content uniformity, including specificity, accuracy and
as recommended. Justification shall repeatability (method precision) performed
be submitted in this regard. by the Drug Product manufacturer for drug
substance(s) is submitted
attached but did not specify from Pine pharmaceuticals and panacea
whom API is borrowed. pharmaceuticals submitted.
 Submit COA’s of all time points  COA’s of all time points for real and
for real and Accelerated stability Accelerated stability studies submitted.
studies.
Decision: Approved.
Rawat, Islamabad.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Ebaspine 20mg tablet
Pharmaceutical ingredient (API) per unit Ebastine …….20mg
Pharmacotherapeutic Group of (API) Antihistamine
Pharmaceutical form of applied drug White to off white, round, unscored, film coated
tablets
The status in reference regulatory authorities Ebastine 20 film coated tablets 10mg Netherland
Approved.
For generic drugs (me-too status) Kestine 20mg tablets by M/s Highnoon
Name and address of API manufacturer. M/s Bal Pharma Unit 2 61-B, Bommasandra
Industrial Area Banglore-560099, Karantaka
State, India
Module-III Drug Substance: Official monograph of Ebastine is present in BP.
Firm has submitted detailed drug substance data
drug substance.
months
months
Batches: (EB/161005, EB/161006, EB/161007)
stability.
Dissolution Profile established against the brand leader that is Kestine
20mg tablet by M/S Highnoon Laboratories
limited Pakistan by performing quality tests
dosage form).
that is Kestine 20mg tablet by M/S Highnoon
Laboratories limited Pakistan in Acid media (pH
1.0-1.2), Acetate buffer (pH-4.5) & Phosphate
acceptable range.
product.
Manufacturer of API M/s Bal Pharma Unit 2 61-B, Bommasandra Industrial Area Banglore-
560099, Karantaka State, India
API Lot No. 5017072109004
Description of Pack
Batch No. TE04 TE05 TE06
No. of Batches 03
M02/2122/EXP/AEX/00219, dated; 27-10-2021
2021 specifying 10Kg of Ebastine batch #
5017072109004.(Panacea pharmaceuticals
data sheets etc.
1. 1.6.5 Valid Drug Manufacturing License Valid Drug Manufacturing License or Valid
or Valid Good Manufacturing Good Manufacturing Practice (GMP)
Practice (GMP) certificate of the certificate of the Drug Substance
Drug Substance manufacturer issued manufacturer issued by relevant regulatory
by relevant regulatory authority of authority of country of origin submitted.
country of origin.
specifications both Drug substance & both Drug substance & Drug Product
Drug Product manufacturer is manufacturer are submitted.
required.
routine testing of the Drug substance testing of the Drug substance /Active
/Active Pharmaceutical Ingredient by Pharmaceutical Ingredient by both Drug
both Drug substance & Drug Product substance & Drug Product manufacturer are
4. 3.2.P.5.2 You have not performed uniformity Analytical Method Verification studies
of dosage unit by content uniformity, including specificity, accuracy and
as recommended. Justification shall repeatability (method precision) performed
be submitted in this regard. by the Drug Product manufacturer for drug
substance(s) is submitted
attached but did not specify from Pine pharmaceuticals and panacea
whom API is borrowed. pharmaceuticals submitted.
 Submit COA’s of all time points  COA’s of all time points for real and
for real and Accelerated stability Accelerated stability studies submitted.
studies.
Decision: Approved.
M/s Fortune Pharma Private Limited. (New DML)
CLB in its 278th meeting held on 10th and 11th December 2020 has considered and approved the grant
of Drug Manufacturing License by way of formulation with following five (05) sections to M/s Fortune
Pharma Private Limited
1. Tablet (General) 2. Liquid Ampoule (General)

3. Liquid Syrup (General) 4. Liquid Vial (General)
5. Capsule (General) 6. Tablet (Psychotropic)
7. Ointment (General) Section 8. Capsule (Psychotropic)
9. Sachet (General) 10. Liquid Ampoule (Psychotropic)
Accordingly, firm has applied for following products for consideration by Drug Registration Board
Tablet (General)
417. Name, address of Applicant / Marketing M/s Fortune Pharma Private Limited
Authorization Holder Head Office Suit # 731, 7th Floor Mashriq Centre,
Opp National Stadium Road Karachi
Name, address of Manufacturing site. M/s Fortune Pharma Private Limited
Plot # K/201,S.I.T.E (SHW) Phase-II, Karachi
☐ Importer
which Sachet Powder (General) section
mentioned.
☐ Export sale
The proposed proprietary name / brand name Mon-Kast 4mg Sachet
Strength / concentration of drug of Active Each Sachet Contains:
Pharmaceutical ingredient (API) per unit Montelukast as Sodium…..4mg
Pharmacotherapeutic Group of (API) Leukotriene receptor antagonist
Pharmaceutical form of applied drug White to off white semisolid filled in Aluminum
tube
The status in reference regulatory authorities SINGULAIR granules for powder 4mg of
(MHRA Approved)
For generic drugs (me-too status) Lucast powder for Solution by M/s AGP Limited
Reg #048716
Name and address of API manufacturer. M/s Morpen Laboratories Limited
Address: Masulkana Parwanoo, Distt. Solan
Himachal Pradesh India.
Module-III Drug Substance: Official monograph of Montelukast Sodium is
drug substance.
months
months
Batches: (MTN14-8015, MTN14-9001,
MTN14-9036)
stability.
Dissolution Profile established against the ‘Lucast 4mg of M/s AGP
Limited, by performing quality tests
Identification, average weight, Assay &
Dissolution).
CDP has been performed against the ‘singulair
4mg of M/s MSD Thailand (importer), in Acidic
product.
Manufacturer of API M/s Morpen Laboratories Limited
Address: Masulkana Parwanoo, Distt. Solan Himachal Pradesh India.
API Lot No. MS/2017003
Description of Pack
Filled in sealed printed foil sachet
Batch No. MK/4-001 MK/4-002
Batch Size 5000 5000
Date of Initiation 01-2022 01-2022
No. of Batches 03
manufacturer issued by concerned regulatory (No.L.HFW-hDrugs) 93/91 dated 23-02-2022
authority of country of origin. issued by Health and family Welfare Department
Himachel Pradesh Baddi, District, Solan India.
Valid till 11-05-2024
data sheets etc.
1. 2.3.R.1.1 Provide copy of Batch Manufacturing Firm submit the Trial Form of two
Record (BMR) for all the batches of batches.
drug product for which stability studies
data is provided in Module 3 section
3.2.P.8.3
2. 3.2.S.4.3 Analytical Method Verification studies Firm submitted the Analytical Method
including specificity, accuracy and Verification studies.
repeatability (method precision)
performed by the Drug Product
manufacturer for drug substance(s) shall
be submitted.
3. 3.2.S.5 COA of primary / secondary reference Firm submitted the COA of reference
standard including source and lot standard montelukast
number of montelukast dicyclohexylamine.
dicyclohexylamine shall be provided
4. 3.2.P.2.2.1  Pharmaceutical equivalence is not Firm in their reply stated that the
conducted against Innovator innovator product was not available at
product. the time of studies, so brand leader was
 CDP and pharmaceutical procured and PE studies was conducted.
equivalence is performed against Later on, as singular was available CDP
two different products. Clarify. was conducted.
5. 3.2.P.8 Documents for the procurement of API Firm submitted the DRAP attested
with approval from DRAP. invoice.
Decision: Approved.
M/s WALLACE PHARMA. (New DML)
CLB in its 284th meeting held on 16th December 2021 has considered and approved the grant of Drug
Manufacturing License by way of formulation with following six (06) sections to M/s WALLACE
PHARMA
1. Capsule (Penicilline) Section

2. Oral Dry powder Suspension (Penicilline) Section
3. Injection (Carbapenem)
4. Dry Powder Injection (Penicilline)Section
Dry Powder Injection (Penicilline) Section
418. Name, address of Applicant / Marketing M/S Wallace Pharma Evolutions, Kalawala Stop,
Authorization Holder 20-Km, Lahore Jaranwala Road, Lahore
Name, address of Manufacturing site. M/S Wallace Pharma Evolutions, Kalawala Stop,
20-Km, Lahore Jaranwala Road, Lahore
☐ Importer
which Dry Powder Injection (Penicilline)Section
mentioned.
☐ Export sale
The proposed proprietary name / brand name TAZOCIN 2.25gm Injection
Pharmaceutical ingredient (API) per unit Piperacillin Sodium (USP) ………....... 2000mg
Tazobactam Sodium (USP) ……….......250mg
(Product Complies USP Specs)
Pharmacotherapeutic Group of (API) combination medication containing the antibiotic
Penicillins and the β-lactamase inhibitor
tazobactam
Pharmaceutical form of applied drug Sterile, preservative-free, clear, white to off white
to yellow color, Powder, free from foreign
particles in a vial with rubber stopper and seals in
unit carton.
The status in reference regulatory authorities Tazocin 2 g / 0.25 g powder for solution for
infusion by Pfizer Limited of MHRA approved
For generic drugs (me-too status) Zosyn 2.25gm INJECTION of M/s Regent
Laboratories Reg# 070759
Name and address of API manufacturer. Shandong Anxin Pharmaceutical Co., Ltd.
Address: No. 849, Dongjia Town, Licheng
District, Jinan, Shandong, China
(Peviously Qilu Tianhe Pharmaceuticals co.,Ltd)
Module-III Drug Substance: Official monograph of Piperacillin + Tazobactam
is present in USP. Firm has submitted detailed
drug substance data related to nomenclature,
structure, general properties, solubility, physical
drug substance.
months
months
Batches: (HF7001D1, HF7001D2, HF7001D3)
stability.
Dissolution Profile established against the is A Tanzo 2.25gm
injection by M/s Bosch Pharmaceuticals (Pvt) Ltd.
by performing quality tests (Identification, pH,
Sterility, Assay,).

product.
Manufacturer of API Shandong Anxin Pharmaceutical Co., Ltd.
Description of Pack Sterile, preservative-free, clear, white to off white to yellow colour,
(Container closure system) Powder, free from foreign particles in a vial with rubber stopper and seals
in unit carton.
Batch Size 460 packs 460 packs 460 packs
Date of Initiation 07.10.22 07.10.22 07.10.22
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. 2018001 issued by
manufacturer issued by concerned regulatory Shandong Food and Drug Administration valid
authority of country of origin. till 24/07/2023.(Qilu Tianhe Pharmaceuticals
co.,Ltd )
3. Documents for the procurement of API with A letter to AD R-II was written from M/s Stallion
approval from DRAP (in case of import). Pharmaceuticals that they lend Piperacilline and
Tazobactum 15kg Batch # HF2065D3 to M/s
Wallace Pharma Evolution on dated: 04-10-2022
Firm has submitted copy of Clearnce certificate #
E-2669242824625 specifying Commercial Invoice
# WWM220705, dated; 30-08-2020 issue by
DRAP Lahore office date: 15-11-2022 specifying
210Kg of Piperacilline Sodium and Tazobactum
Sodium Sterile batch # HF2065D3.(Stallion
Pharmaceuticals Pvt Ltd)
data sheets etc.
5. Compliance Record of HPLC software 21CFR & Submitted.
S.No Section Shortcoming communicated
1. 2.3.R.1.1 Piperacillin Sodium and Tazobactam Sodium are in premixed for (8:1) than how
separately dispensed per Vial.
2. 3.2.S.4.1 Copies of the Drug substance specifications Drug Product manufacturer is required.
3. 3.2.S.4.2 Analytical procedures used for routine testing of the Drug substance /Active
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) shall be submitted.
5. 3.2.S.4.4 Which specifications are followed by drug product manufacturer for drug
substance.
6. 3.2.P.1 Clarify it is ready to fill form or further processing is done by you with addition of
excipients.
7. 3.2.P.2.6 Compatibility studies with diluent for the dry powder for injections shall be
performed as per the instructions provided in individual label of the drug product.
8. 3.2.P.5.3 Analytical method verifications protocols for drug product shall be submitted.
9. 3.2.P.5.4 Water determinations was not done on all the 3 batches as mentioned in USP
monograph. Clarification is required.
10. 3.2.P.8  Submit packaging list of import of material.
 Water determinations was not done in both Real and accelerated stability
studies as mentioned in USP monograph. Clarification is required.
419. Name, address of Applicant / Marketing M/S Wallace Pharma Evolutions, Kalawala Stop,
Authorization Holder 20-Km, Lahore Jaranwala Road, Lahore
Name, address of Manufacturing site. M/S Wallace Pharma Evolutions, Kalawala Stop,
20-Km, Lahore Jaranwala Road, Lahore
☐ Importer
which Dry Powder Injection (Penicilline)Section
mentioned.
☐ Export sale
The proposed proprietary name / brand name TAZOCIN 4.5gm Injection
Pharmaceutical ingredient (API) per unit Piperacillin Sodium (USP) ………....... 4000mg
Tazobactam Sodium (USP) ……….......500mg
(Product Complies USP Specs)
Pharmacotherapeutic Group of (API) a combination medication containing the
antibiotic piperacillin and the β-lactamase
inhibitor tazobactam
Pharmaceutical form of applied drug Sterile, preservative-free, clear, white to off white
to yellow color, Powder, free from foreign
particles in a vial with rubber stopper and seals in
unit carton.
The status in reference regulatory authorities Tazocin 4 g / 0.5 g powder for solution for
.infusion by Pfizer Limited of MHRA approved
For generic drugs (me-too status) Zosyn 4.5gm INJECTION of M/s Regent
Laboratories Reg# 070759
Name and address of API manufacturer. Shandong Anxin Pharmaceutical Co., Ltd.
Address: No. 849, Dongjia Town, Licheng
District, Jinan, Shandong, China
(Peviously Qilu Tianhe Pharmaceuticals co.,Ltd)
Module-III Drug Substance: Official monograph of Piperacillin + Tazobactam
is present in USP. Firm has submitted detailed
drug substance data related to nomenclature,
structure, general properties, solubility, physical
drug substance.
months
months
Batches: (HF7001D1, HF7001D2, HF7001D3)
stability.
Dissolution Profile established against the is A Tanzo 4.5gm injection
by M/s Bosch Pharmaceuticals (Pvt) Ltd. by
performing quality tests (Identification, pH,
Sterility, Assay,).
product.
Manufacturer of API Shandong Anxin Pharmaceutical Co., Ltd.
Description of Pack Sterile, preservative-free, clear, white to off white to yellow colour,
(Container closure system) Powder, free from foreign particles in a vial with rubber stopper and seals
in unit carton.
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. 2018001 issued by
manufacturer issued by concerned regulatory Shandong Food and Drug Administration valid
authority of country of origin. till 24/07/2023.(Qilu Tianhe Pharmaceuticals
co.,Ltd )
3. Documents for the procurement of API with A letter to AD R-II was written from M/s Stallion
approval from DRAP (in case of import). Pharmaceuticals that they lend Piperacilline and
Tazobactum 15kg Batch # HF2065D3 to M/s
Wallace Pharma Evolution on dated: 04-10-2022
Firm has submitted copy of Clearnce certificate #
E-2669242824625 specifying Commercial Invoice
# WWM220705, dated; 30-08-2020 issue by
DRAP Lahore office date: 15-11-2022 specifying
210Kg of Piperacilline Sodium and Tazobactum
Sodium Sterile batch # HF2065D3.(Stallion
Pharmaceuticals Pvt Ltd)
data sheets etc.
S.No Section Shortcoming communicated
1. 2.3.R.1.1 Piperacillin Sodium and Tazobactam Sodium are in premixed for (8:1) than how
separately dispensed per Vial.
2. 3.2.S.4.1 Copies of the Drug substance specifications Drug Product manufacturer is required.
4. 3.2.S.4.3 Analytical Method Verification studies including specificity, accuracy and
5. 3.2.S.4.4 Which specifications are followed by drug product manufacturer for drug
substance.
6. 3.2.P.1 Clarify it is ready to fill form or further processing is done by you with addition of
excipients.
7. 3.2.P.2.6 Compatibility studies with diluent for the dry powder for injections shall be
performed as per the instructions provided in individual label of the drug product.
8. 3.2.P.5.3 Analytical method verifications protocols for drug product shall be submitted.
9. 3.2.P.5.4 Water determinations was not done on all the 3 batches as mentioned in USP
monograph. Clarification is required.
10. 3.2.P.8  Submit packaging list of import of material.
 Water determinations was not done in both Real and accelerated stability
studies as mentioned in USP monograph. Clarification is required.
Decision: Registration Board deferred the case for submission of reply to the above cited shortcomings
and evaluation by PE&R Division.
Deferred case
M/s Nagarsons Pharmaceutical (Pvt) Ltd. (New DML)
Firm has submitted copy of Acknowledgment of receipt of application for grant of DML by way of
formulation to M/s Nagarsons Pharmaceuticals dated 19-02-2021 from Secretary Central Licensing
Board. The letter specifies that CLB in its 278th meeting held on 10th and 11th December 2020 has
approved the grant of DML in the name of M/s Nagarsons Pharmaceuticals for following sections:
1. Tablet (General)
2. Tablet (Psychotropic)
4. Cream /ointment/Lotion/Gel

meeting meeting
1 Tablet (General) 01 02
420. Name, address of Applicant / Marketing M/s Nagarsons Pharmaceutical (Pvt) Ltd
Authorization Holder Plot No.34, street No. NS-2, National Industries
Zone, Rawat Islamabad.
Name, address of Manufacturing site. M/s Nagarsons Pharmaceutical (Pvt) Ltd
Plot No.34, street No. NS-2, National Industries
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Relpride Tablet 25mg
Strength / concentration of drug of Active Each Tablet Contains;
Pharmaceutical ingredient (API) per unit Levosulpiride ………. 25 mg
Pharmacotherapeutic Group of (API) Propulsive/Prokinetics
The status in reference regulatory authorities Levosulpiride Aristo 25 mg tablets, AIFA Italy
approved.
For generic drugs (me-too status) Sulvoric 25mg Tablet of M/s High-Q Reg.
No.070484
GMP status of the Finished product manufacturer New license granted on 19th Feburary 2021.
Name and address of API manufacturer. M/s Alcon Biosciences Private Ltd. A-1/2014, Phase-
III, G.I.D.C Vapi, District Valsad Gujrat, India.
Module III (Drug Substance) Official monograph of Levosulpiride is not present in
any pharmacopeia. The firm as submitted detail of
solubility’s, physical form, manufacturers, description
of manufacturing process and controls, tests for
impurity, specifications, analytical procedures and its
Batches: (ALC/LSP/170203, ALC/LSP/170204,
ALC/LSP/170205)
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence is established against
dissolution profile the brand that is LEVOPRAID 25 mg Tablets by M/s
Pacific Pharma (Pvt.) Ltd., B. No. AP0909Q by
performing quality tests (description, Assay,
Dissolution).
is LEVOPRAID 50 mg Tablets by M/s Pacific
Pharma (Pvt.) Ltd., in Acid media (pH 1.2), Acetate
buffer (pH 4.5) & Phosphate Buffer (pH 6.8).
Analytical method validation/verification of
product
Manufacturer of API M/s Alcon Biosciences Private Ltd. A-1/2014, Phase-III, G.I.D.C Vapi, District
Valsad Gujrat, India.
API Lot No. BLEVS210029
Description of Pack
Alu-Alu blister packed
Batch Size 2000 2000 2000
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No# S-GMP/22113654
manufacturer issued by concerned regulatory issued by Food and Drug Control Administration
authority of country of origin. Gandhinagar, Gujrat state India. issued on 04-11-2022
and valid until 03-11-2024.
3. Documents for the procurement of API with Firm has submitted copy form 5 and invoice (invoice#
approval from DRAP (in case of import). AB/I/00101/21-22 ) dated: 01-09-2021 attested by
DRAP Islamabad dated: 13-9-2021 specifying import
of 10Kg Levosulpiride (Batch# BLEVS210029)
4. Data of stability batches will be supported by The firm has submitted Data of stability batches
attested respective documents like supported by attested respective documents like
chromatograms, chromatograms, raw data sheets, COA, summary data
Raw data sheets, COA, summary data sheets etc. sheets etc.
6. Record of Digital data logger for temperature and Not submitted
S.No Section Shortcomings Communicated
1. 1.3.5. GMP inspection report/ GMP certificate of the manufacturing unit issued within the
last three years shall be submitted.
2. 1.6.5 Valid Drug Manufacturing License or Valid Good Manufacturing Practice (GMP)
certificate of the Drug Substance manufacturer issued by relevant regulatory authority
of country of origin
3. 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
4. 3.2.S.4.1 Copies of the Drug substance specifications by Drug Product manufacturer is required.
6. 3.2.P.2.2.1  Justification shall be submitted for not carrying the CDP against the
innovator’s brand
 Details and picture/image/ snapshot of product against which Pharmaceutical
Equivalence and CDP conducted.
 6 units of each of both test and reference product are used for CDP.
Clarification is required in the light of FDA guidance for industry and EMA
guidelines of Comparative dissolution.
 As per Innovator product in CDP percentage dissolved is higher than 85% at
15 minutes in all the 03 media i.e HCl 0.1N, 4.5 and pH 6.8 while as per your
CDP data higher than 85% at 30 minutes. Justification is required.
7. 3.2.P.5.1 Applied formulations in section 1.5.6 are Innovator while in this section USP
specifications are clamed. Clarify.
8. 3.2.P.5.3 Analytical method verification submitted while product is not available in any
pharmacopeia.
9. 3.2.P.8  Documents for the procurement of API with approval from DRAP as submitted
Commercial Invoice is not in readable form.
 Batch size is not mentioned
 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-327): Registration Board was apprised that the letter of shortcoming has been initially issued
to the firm, hence Board deferred the case for submission of reply to the above cited shortcomings within six
months.
Evaluation by PEC:

1. 1.3.5. GMP inspection report/ GMP We are new license facility and there fore till date
certificate of the manufacturing our GMP inspection is not yet carried out by DRAP.
unit issued within the last three
years shall be submitted.
2. 1.6.5 Valid Drug Manufacturing GMP certificate of API manufacturer is attached.
License or Valid Good
Manufacturing Practice (GMP) Copy of GMP certificate No# S-GMP/22113654
certificate of the Drug issued by Food and Drug Control Administration
Substance manufacturer issued Gandhinagar, Gujrat state India. issued on 04-11-
by relevant regulatory authority 2022 and valid until 03-11-2024.
3. 2.3.R.1.1 Provide copy of Batch Copy of BMR of three batches is attached.
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
4. 3.2.S.4.1 Copies of the Drug substance Drug substance specifications of Nagarsons
specifications by Drug Product Pharmaceutical submitted.
5. 3.2.S.4.2 Analytical procedures used for Drug substance analytical procedure of Nagarsons
routine testing of the Drug Pharmaceutical submitted.
substance /Active
Pharmaceutical Ingredient by
required.
6. 3.2.P.2.2.1  Justification shall be  Pharmaceutical equivalence and CDP studies
submitted for not have been performed against Levopraid tablet
carrying the CDP which is the brand leader in Pakistan, since the
against the innovator’s innovator’s product is not registered in
brand Pakistan. Moreover, the comparator brand
 Details and Levopraid is registered in Pakistan under the
picture/image/ snapshot License of a reference product Levopraid tablet
of product against of Ravizza Farmaceutici Italy.
which Pharmaceutical  CDP studies have been performed using 6 units
Equivalence and CDP of each, since we have 12 basket dissolution
conducted. apparatus and all our products have been
 6 units of each of both registered by Registration Board in which CDP
test and reference studies have been performed using 12 basket
product are used for apparatus. Moreover, we undertake to procure
CDP. Clarification is dissolution apparatus with 24 baskets for CDP
required in the light of studies in future.
FDA guidance for  Revised CDP with 75RPM in three media i.e in
industry and EMA Acid media (pH 1.2), Acetate buffer (pH 4.5)
guidelines of & Phosphate Buffer (pH 6.8) percentage
Comparative dissolved is higher than 85% at 15 minutes in
dissolution. all the 03 media i.e HCl 0.1N, 4.5 and pH
 As per Innovator 6.8.(initially firm used 50 RPM so higher than
product in CDP 85% at 30 minutes in all the 03 media i.e HCl
percentage dissolved is 0.1N, 4.5 and pH 6.8)
higher than 85% at 15
minutes in all the 03
media i.e HCl 0.1N, 4.5
and pH 6.8 while as per
your CDP data higher
than 85% at 30
minutes. Justification is
required.
7. 3.2.P.5.1 Applied formulations in section There was some typo error while drafting our
1.5.6 are Innovator while in this specifications are as innovator’s product since no
section USP specifications are USP or BP monograph exist for this product
clamed. Clarify.
8. 3.2.P.5.3 Analytical method verification Analytical method validation studies are provided.
submitted while product is not
available in any pharmacopeia.
9. 3.2.P.8  Documents for the  Commercial Invoice attested by DRAP
procurement of API with Islamabad submitted.
approval from DRAP as  Batch size of our stability batches is 2000.
submitted Commercial
Invoice is not in readable (Batch size in BMR is 2000 mentioned while
form. on Raw data sheets of stability studies data
 Batch size is not mentioned Batch size of 2500 Tablets mentioned.)
 Compliance Record of
HPLC software 21CFR &  Our HPLC system is not 21 CFR compliant
audit trail reports on product therefore audit trail report is not available.
testing. However, we have maintained complete log of
 Record of Digital data he equipment as well as product testing as per
logger for temperature and GMP requirements.
humidity monitoring of  Record of Digital data logger is provided.
stability chambers (real
Decision: Approved.
421. Name, address of Applicant / Marketing M/s. Nagarsons Pharmaceutical (Pvt) Ltd
Authorization Holder Plot No.34, street No. NS-2, National Industries
Name, address of Manufacturing site. M/s. Nagarsons Pharmaceutical (Pvt) Ltd
Plot No.34, street No. NS-2, National Industries
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Relpride Tablet 50mg
Strength / concentration of drug of Active Each Tablet Contains;
Pharmaceutical ingredient (API) per unit Levosulpiride ………. 50 mg
Pharmacotherapeutic Group of (API) Propulsive/Prokinetics
The status in reference regulatory authorities Levosulpiride Aristo 50 mg tablets, AIFA Italy
approved.
For generic drugs (me-too status) Sulvoric 50mg Tablet of M/s High-Q Reg.
No.070485
GMP status of the Finished product manufacturer New license granted on 19th Feburary 2021.
Name and address of API manufacturer. M/s Alcon Biosciences Private Ltd. A-1/2014, Phase-
III, G.I.D.C Vapi, District Valsad Gujrat, India.
Module III (Drug Substance) Official monograph of Levosulpiride is not present in
any pharmacopeia. The firm as submitted detail of
tests for impurity, specifications, analytical
substance
Batches: (ALC/LSP/170203, ALC/LSP/170204,
ALC/LSP/170205)
dissolution profile the brand that is LEVOPRAID 50 mg Tablets by M/s
Pacific Pharma (Pvt.) Ltd., by
performing quality tests (description, Assay,
Dissolution).
is LEVOPRAID 50 mg Tablets by M/s Pacific
Pharma (Pvt.) Ltd., in Acid media (pH 1.2), Acetate
buffer (pH 4.5) & Phosphate Buffer (pH 6.8).
Analytical method validation/verification of
product
Manufacturer of API M/s Alcon Biosciences Private Ltd. A-1/2014, Phase-III, G.I.D.C Vapi, District
Valsad Gujrat, India.
API Lot No. BLEVS210029
Description of Pack
Alu-Alu blister packed
Batch Size 2500/2000 2500/2000 2500/2000
No. of Batches 03
authority of country of origin. Gandhinagar, Gujrat state India. issued on 22-10-
2020 and valid until 21-10-2022.
3. Documents for the procurement of API with Not submitted
1. 1.3.5. GMP inspection report/ GMP certificate of the manufacturing unit issued within the
last three years shall be submitted.
certificate of the Drug Substance manufacturer issued by relevant regulatory authority
3. 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
6. 3.2.P.2.2.1  Justification shall be submitted for not carrying the CDP against the
innovator’s brand
 Details and picture/image/ snapshot of product against which Pharmaceutical
Equivalence and CDP conducted.
 6 units of each of both test and reference product are used for CDP.
Clarification is required in the light of FDA guidance for industry and EMA
guidelines of Comparative dissolution.
 As per Innovator product in CDP percentage dissolved is higher than 85% at
15 minutes in all the 03 media i.e HCl 0.1N, 4.5 and pH 6.8 while as per your
CDP data higher than 85% at 30 minutes. Justification is required.
7. 3.2.P.5.1 Applied formulations in section 1.5.6 are Innovator while in this section USP
specifications are clamed. Clarify.
8. 3.2.P.5.3 Analytical method verification submitted while product is not available in any
pharmacopeia.
9. 3.2.P.8  Documents for the procurement of API with approval from DRAP. (Clear
Commercial Invoice).
testing.
Previous Decision (M-327): Registration Board was apprised that the letter of shortcoming has been initially
six months
Evaluation by PEC:

1. 1.3.5. GMP inspection report/ GMP We are new license facility and there fore till date
certificate of the manufacturing our GMP inspection is not yet carried out by DRAP.
unit issued within the last three
years shall be submitted.
2. 1.6.5 Valid Drug Manufacturing GMP certificate of API manufacturer is attached.
License or Valid Good
Manufacturing Practice (GMP) Copy of GMP certificate No# S-GMP/22113654
certificate of the Drug issued by Food and Drug Control Administration
Substance manufacturer issued Gandhinagar, Gujrat state India. issued on 04-11-
by relevant regulatory authority 2022 and valid until 03-11-2024.
3. 2.3.R.1.1 Provide copy of Batch Copy of BMR of three batches is attached.
Manufacturing Record (BMR)
for all the batches of drug
product for which stability
4. 3.2.S.4.1 Copies of the Drug substance Drug substance specifications of Nagarsons
specifications by Drug Product Pharmaceutical submitted.
5. 3.2.S.4.2 Analytical procedures used for Drug substance analytical procedure of Nagarsons
routine testing of the Drug Pharmaceutical submitted.
substance /Active
required.
6. 3.2.P.2.2.1  Justification shall be  Pharmaceutical equivalence and CDP studies
submitted for not carrying have been performed against Levopraid tablet
the CDP against the which is the brand leader in Pakistan, since the
innovator’s brand innovator’s product is not registered in Pakistan.
 Details and picture/image/ Moreover, the comparator brand Levopraid is
snapshot of product against registered in Pakistan under the License of a
which Pharmaceutical reference product Levopraid tablet of Ravizza
Equivalence and CDP Farmaceutici Italy.
conducted.  CDP studies have been performed using 6 units
 6 units of each of both test of each, since we have 12 basket dissolution
and reference product are apparatus and all our products have been
used for CDP. Clarification registered by Registration Board in which CDP
is required in the light of studies have been performed using 12 basket
FDA guidance for industry apparatus. Moreover, we undertake to procure
and EMA guidelines of dissolution apparatus with 24 baskets for CDP
Comparative dissolution. studies in future.
 As per Innovator product in  Revised CDP with 75RPM in three media i.e in
CDP percentage dissolved is Acid media (pH 1.2), Acetate buffer (pH 4.5) &
higher than 85% at 15 Phosphate Buffer (pH 6.8) percentage dissolved
minutes in all the 03 media is higher than 85% at 15 minutes in all the 03
i.e HCl 0.1N, 4.5 and pH 6.8 media i.e HCl 0.1N, 4.5 and pH 6.8.(initially
while as per your CDP data firm used 50 RPM so higher than 85% at 30
higher than 85% at 30 minutes in all the 03 media i.e HCl 0.1N, 4.5
minutes. Justification is and pH 6.8)
required.
7. 3.2.P.5.1 Applied formulations in section There was some typo error while drafting our
1.5.6 are Innovator while in this specifications are as innovator’s product since no
section USP specifications are USP or BP monograph exist for this product
clamed. Clarify.
8. 3.2.P.5.3 Analytical method verification Analytical method validation studies are provided.
submitted while product is not
available in any pharmacopeia.
9. 3.2.P.8  Documents for the  Commercial Invoice attested by DRAP
procurement of API with Islamabad submitted.
approval from DRAP as  Batch size of our stability batches is 2000.
submitted Commercial
(Batch size in BMR is 2000 mentioned while
Invoice is not in readable on Raw data sheets of stability studies data
form. Batch size of 2500 Tablets mentioned.)
 Compliance Record of  Our HPLC system is not 21 CFR compliant
HPLC software 21CFR & therefore audit trail report is not available.
audit trail reports on product However we have maintained complete log of
testing. he equipment as well as product testing as per
 Record of Digital data GMP requirements.
logger for temperature and  Record of Digital data logger is provided.
humidity monitoring of
stability chambers (real
Decision: Approved.
422. Name, address of Applicant / Marketing M/s AGM Pharmaceuticals Eminabad Road, G.T.
Authorization Holder Road, Gujranwala, Pakistan
Name, address of Manufacturing site. M/s AGM Pharmaceuticals Eminabad Road, G.T.
Road, Gujranwala, Pakistan
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Pirogm 20mg Capsule
Strength / concentration of drug of Active Each Hard gelatin capsule contains:
Pharmaceutical ingredient (API) per unit Piroxicam….…20mg
Pharmacotherapeutic Group of (API) NSAID
Proposed Pack size 2×10’s
Feldene 20 mg Capsule by M/s Pfizer of USFDA
Approved
For generic drugs (me-too status) Feldene 20 mg Capsule by M/s Pfizer Reg#006349
GMP status of the Finished product manufacturer New DML issued on 10/11/2021
Name and address of API manufacturer. Alcon Biosciences Pvt Ltd. A-1/2104, Phase-III,
GIDC, VAPI, 396195, District Valsad, Gujrat India.
solubility’s, physical form, manufacturers, description
Module III (Drug Substance) Official monograph of Piroxicam is present in BP. The
firm as submitted detail of nomenclature, structure,
general properties, solubility’s, physical form,
and controls, tests for impurity, specifications,
studies of drug substance
Batches: (ALC/PCM/131205, ALC/PCM/131206,
ALC/PCM/131207)
dissolution profile against the brand leader that is Feldene capsule 20mg
by Pfizer by performing quality tests (Identification,
Assay, Dissolution, Uniformity of dosage form).
is Feldene capsule 20mg by Pfizer in Acid media (pH
1.0-1.2) & Phosphate Buffer (pH 6.8). The values for
f1 and f2 are in the acceptable range.
product accuracy, precision, specificity.
Manufacturer of API Alcon Biosciences Pvt Ltd. A-1/2104, Phase-III, GIDC, VAPI,
396195, District Valsad, Gujrat India.
API Lot No. PCM-22041
Description of Pack
Batch No. TRC001 TRC002 TRC003
Batch Size 1500 2000 2000
No. of Batches 03
authority of country of origin. Gandhinagar, Gujrat state India. issued on 22-10-2020
and valid until 21-10-2022.
3. Documents for the procurement of API with Firm has submitted copy of Form invoice (invoice#
approval from DRAP (in case of import). AV/I/00062/22-23 ) dated: 13-11-2021 specifying
import 200gm Piroxicam (Batch# PCM-22041)
5. Compliance Record of HPLC software 21CFR & The firm has submitted Compliance Record of HPLC
audit trail reports on product testing software 21CFR & audit trail reports on product
testing.
6. Record of Digital data logger for temperature and The firm has submitted Record of Digital data logger
humidity monitoring of stability chambers (real for temperature and humidity monitoring of stability
time and accelerated) chambers (real time and accelerated).
Remarks of Evaluator: During Evaluation it was observed that AGM pharmaceuticals, Gujranwala and Pharman
Pharmaceutical, Gujranwala DML have same Name of Production in charge.
1. 1.6.5 Valid Drug Manufacturing Not submitted.
License Or Valid Good
Manufacturing Practice (GMP)
certificate of the Drug
Substance manufacturer issued
by relevant regulatory authority
of country of origin.
2. 3.2.S.4.3 Analytical Method Verification USP specifications was applied for API testing
studies Submitted by HPLC that’s why HPLC AMV studies were submitted.
while B.P specifications are
claimed by drug product Evaluation: Firm claimed BP specification in COA
manufacturer. of drug substance and limits are also according to
BP i.e Assay limits applied are 98.5% to 101.0%
which are according to BP specifications while USP
specifications for Assay are 97.0% to 103.0%
3. 3.2.P.1 DC granular used as excipient in DC lactose granular was used but lactose word was
formulation. Explain what is DC skipped. It is a typographical error. Revised
granular. documents submitted.
4. 3.2.P.5.1 Submit complete Specifications Specification as per USP monograph are attached
as per USP monograph.
5. 3.2.P.5.2 Submit analytical testing Analytical testing method of drug product
method of drug product instead submitted.
of USP monograph
presentation.
6. 3.2.P.5.4 Water content as per USP Water content is tested on next time point and report
monograph not Performed. is attached.
Clarification is required.
7. 3.2.P.8 Documents for the procurement Commercial invoice without DRAP approval
of API with approval from submitted.
DRAP.
Previous Decision (M-326): Deferred for following:
 Submission of valid Drug Manufacturing License or valid Good Manufacturing Practice (GMP)
 certificate of the Drug Substance manufacturer issued by relevant regulatory authority of country
 of origin.
 Justification for applying USP monograph for the drug substance analysis and analytical method
 verification studies whereas drug product manufacturer has claimed BP specifications for the drug
 substance.
 Documents for the procurement of API with approval from DRAP.
Registration Board was further apprised that during evaluation it was identified that “Production In charge” of two
firms i.e., M/s AGM Pharmaceuticals Eminabad Road, G.T. Road, Gujranwala & M/s Pharman Pharmaceuticals
6 Km, Bohmaan Bath Road, Kalasky, Gujranwala, was same, as evident form submitted documents. Hence
Registration Board advised PE&R Division to refer the case to Licensing Division for clarification/necessary
action.
Evaluation by PEC:
S.No Reason of deferment Reply
1) Submission of valid Drug Manufacturing Valid Drug Manufacturing License And valid Good
License or valid Good Manufacturing Practice Manufacturing Practice (GMP) Certificate is
(GMP) certificate of the Drug Substance attached
manufacturer issued by relevant regulatory
authority of country
of origin.
2) Justification for applying USP monograph for We are applying USP monograph for Drug
the drug substance analysis and analytical Substance and Drug Product with all parameters.
method verification studies whereas drug Due to typographical mistake on claimed BP
product manufacturer has claimed BP Specification
specifications for the drug
substance.
3) Documents for the procurement of API with We used Loan material from Batala Pharma. Loan
approval from DRAP. letter is attached.
Commercial invoice #2020-21/000447 dated: 05-11-
2020 Approved by DRAP Lahore dated: 04-12-2020
specifying import of
action.
Justification:
We, M/s AGM Pharmaceuticals, ensure that during the hiring process of technical staff for the positions of
Production Incharge and Quality Control, we abide by the Manual of Drug Law. Both the CEO and the technical
staff are required to sign an undertaking stating that they are full-time employees of our firm and do not work
elsewhere. In case of any violation, the responsible person will face necessary action from DRAP (Drug
Regulatory Authority of Pakistan).
Furthermore, we have also made changes to our technical staff and have applied for an approval letter from the
Licensing Department of DRAP. Attached is the evidence of our application for the approval of the technical staff.
Decision: Approved. Registration letter will be issued upon submission of fee of Rs. 7,500/- for pre-approval
change in drug substance specifications
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Ag-CIP 250mg tablet
Pharmaceutical ingredient (API) per unit Ciprofloxacin HCl…250mg
Pharmacotherapeutic Group of (API) Antibiotic (fluoroquinolone)
The status in reference regulatory authorities Ciprofloxacin 50MG film coated tablet.
Manufactured M/s Aurobindo Phrma-Milpharm Ltd.
MHRA Approved.
For generic drugs (me-too status) NOVIDAT 250mg tab by M/s Sami Pharma #011836
Name and address of API manufacturer. Citi Pharma (Pvt.) Ltd.
3.5 Kilometer, Head Balloki Road, Phool Nagar,
Kasur -55050 Punjab, Pakistan.
Module III (Drug Substance) Official monograph of Ciprofloxacin Hydrochloride
is present in USP . The firm as submitted detail of
substance
Batches: (CPH1402007, CPH1402008,
CPH1402009)
its verification studies, batch analysis and justification
of specification, reference standard, container closure
dissolution profile against the brand leader that is Novidat 250mg tablet
BY SAMI Pharma by performing quality tests
dosage form).
is Ciprofloxacin 250mg tablet Tablet by SAMI
Pharma in Acid media (pH 1.0-1.2) & Phosphate
acceptable range.
Manufacturer of API Citi Pharma (Pvt.) Ltd.
3.5 Kilometer, Head Balloki Road, Phool Nagar, Kasur -55050 Punjab, Pakistan.
API Lot No. CPH2112137
Description of Pack
Batch No. TRT-019 TRT-020 TRT-021
Batch Size 1500 1500 1500
Manufacturing Date 12-21 13-12-21 14-12-2021
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate issued by DRAP on the
manufacturer issued by concerned regulatory basis of Evaluation conducted on 17-12-2020 and
authority of country of origin. valid for 2 years.
attested respective documents like chromatograms, supported by attested respective documents like
Raw data sheets, COA, summary data sheets etc. chromatograms, raw data sheets, COA, summary data
sheets etc.
testing.
3. 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)
shall be submitted.
4. 3.2.S.4.4 In COA by drug product manufacturer result for water content shows comply instead
of value. Justify
5. 3.2.S.2.2.1 In CDP time points are up to 5,10,15,20,25,30 minutes while in calculation of F1 and
F2 up to 5,10,15,20,25, 45 minutes are mentioned. Clarify. .
6. 3.2.P.5.3 Submit Protocols of Analytical method verifications.
7. 3.2.P.6 COA of reference standard Ciprofloxacin Ethylenediamine Analoge
8. 3.2.P.8 Purchase documents for Ciprofloxacin HCl.
COA’s of all time points does not match with stability summary sheets abd raw data.
In raw data sheets Batch NO TRC-019, TRC-020, TRC-021 while in all other
documents Batch no # TRT-019, TRT-020, TRT-021. Clarify
six months.
Registration Board was further apprised that during evaluation it was identified that “Production In charge” of
two firms i.e., M/s AGM Pharmaceuticals Eminabad Road, G.T. Road, Gujranwala & M/s Pharman
Pharmaceuticals 6 Km, Bohmaan Bath Road, Kalasky, Gujranwala, was same, as evident form submitted
documents. Hence Registration Board advised PE&R Division to refer the case to Licensing Division for
clarification/necessary action.
Evaluation by PEC: A fee of Rs: 7500/- deposit slip # 54345238 for pre RegistrationVariation
1. 3.2.S.4.1 Copies of the Drug substance Specifications by Drug Product are submitted.
specifications by Drug Product
2. 3.2.S.4.2 Analytical procedures used for Analytical procedures of Drug substance are
routine testing of the Drug submitted
substance /Active
required.
3. 3.2.S.4.3 Analytical Method Verification Analytical Method Verification of drug substance
studies including specificity, performed by the Drug Product are submitted.
accuracy and repeatability
(method precision) performed
by the Drug Product
manufacturer for drug
substance(s) shall be submitted.
4. 3.2.S.4.4 In COA by drug product Test was performed but at the time of documentation
manufacturer result for water value was skipped. Revised certificate of analysis is
content shows comply instead of submitted
value. Justify
5. 3.2.S.2.2.1 In CDP time points are up to
5,10,15,20,25,30 minutes while
Revised CDP with correct calculation of f1 and f2
in calculation of f1 and f2 up to
with time points 5,10,15,20,25,30 are submitted
5,10,15,20,25, 45 minutes are
mentioned. Clarify. .
6. 3.2.P.5.3 Submit Protocols of Analytical Protocols of Analytical method verifications are
method verifications. submitted
7. 3.2.P.6 COA of reference standard For stability testing, system suitability solution was
Ciprofloxacin Ethylenediamine not used. After registration, we will use system
Analogue suitability solution and will follow the method as per
the USP monograph.
8. 3.2.P.8  Purchase documents for 05 kg Purchase Invoice of Ciprofloxacin HCl. From

Ciprofloxacin HCl. Citi pharma is attached
 COA’s of all time points Our stability trail batch Nos. is TRT-019, TRT-020,
does not match with TRT-021 and all other documents raw data analysis
stability summary sheets sheets mentioned batch no. in typographic error.
and raw data. Clarification Revised documents are attached
is required.
 In raw data sheets Batch,
NO TRC-019, TRC-020,
TRC-021 while in all other
documents Batch no # TRT-
019, TRT-020, TRT-021.
Clarify
action.
Justification:
We, M/s AGM Pharmaceuticals, ensure that during the hiring process of technical staff for the positions of
Production Incharge and Quality Control, we abide by the Manual of Drug Law. Both the CEO and the technical
staff are required to sign an undertaking stating that they are full-time employees of our firm and do not work
elsewhere. In case of any violation, the responsible person will face necessary action from DRAP (Drug
Regulatory Authority of Pakistan).
Furthermore, we have also made changes to our technical staff and have applied for an approval letter from the
Licensing Department of DRAP. Attached is the evidence of our application for the approval of the technical staff.
Decision: Approved. Registration letter will be issued upon submission of fee of Rs. 7,500/- for pre-approval
change in drug substance specifications
☐ Importer
☐ Export sale
The proposed proprietary name / brand name G-Mol 500mg Tablet
Pharmaceutical ingredient (API) per unit Paracetamol…500mg
Pharmacotherapeutic Group of (API) Analgesic and anti pyretic
Not found

1. 1.5.9 Evidence of approval / registration / marketing status of the applied formulation in the
same composition, salt form and dosage form (Film coated Tablet ) in any one of the
reference regulatory authority specified by Registration Board in its 275 th meeting for
further evaluation of application.
Previous Decision (M-326): Registration Board deferred the application for submission of Product development,
Pharmaceutical Equivalence ,CDP, Batch manufacturing record and complete stability studies for revised
formulation of “uncoated tablet”.
Evaluation by PEC: A fee of Rs: 7500/- deposit slip # 7593549277 for pre-Registration Variation
S.No Shortcomings Communicated Reply
1. Product Development We, M/s AGM Pharma, during the product development of G-Mol
500mg Tablet (Paracetamol), followed the British Pharmacopeia
monograph/method for an uncoated tablet. However, unintentional
mistakes were made during the preparation of the CTD Dossier
documentation from our side. Further we have submitted the fee for
the preregistration variation as per the SRO.
2. Pharmaceutical Equivalence Fresh Pharmaceutical Equivalence with comparative Dissolution
with CDP Profile is Attached.
3. Batch Manufacturing Record Revised Batch Manufacturing Record is attached
4. Complete stability studies for Stability studies of G-Mol 500mg Tablet (Paracetamol) were also
revised formulation of uncoated conducted for the uncoated tablet formulation. Complete stability
tablet study Record is Attached
Evaluation of application
Name, address of Applicant / Marketing M/s AGM Pharmaceuticals Eminabad Road, G.T.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name G-Mol 500mg Tablet
Pharmaceutical ingredient (API) per unit Paracetamol…500mg
Pharmacotherapeutic Group of (API) Analgesic and anti pyretic
The status in reference regulatory authorities Paracetamol 500MG tablet of USFDA Approved.
For generic drugs (me-too status) Panadol 500mg Tablet of M/s GSK
structure, general properties, solubility’s, physical
Batches: (TRT016, TRT017, TRT018)
dissolution profile against the brand leader that is Panadol 500mg
capsules BY GSK Pharma by performing quality tests
dosage form).
is PARACETAMOL TABLET 500MG capsule by
GSK in Acid media (pH 1.0-1.2) & Phosphate Buffer
(pH 6.8). The values for f1 and f2 are in the acceptable
range.
3.5 Kilometer, Head Balloki Road, Phool Nagar, Kasur -55050 Punjab, Pakistan.
API Lot No. PGP21-401
Description of Pack
Batch No. TRT016 TRT017 TRT018
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate issued by DRAP on the
manufacturer issued by concerned regulatory basis of Evaluation conducted on 17-12-2020 and
authority of country of origin. valid for 2 years.
3. Documents for the procurement of API with Local purchase.
testing.
Decision: Deferred for submission of complete new pharmaceutical development data including the stability
data of newly formulated trial batches along with full fee of registration.
b. New/Additional section(s)
Deferred case
M/s PDH Laboratories Pvt Ltd. (New Section)
CLB in its 285th meeting held on 17th & 18th March 2022, has approved the following 01 additional
sections
of M/s PDH Laboratories Pvt Ltd.
1.Oral liquid Section ( General ) Additional

meeting meeting
1 Oral liquid Section ( General ) 01 02
425. Name, address of Applicant / Marketing M/s PDH Laboratories Pvt Ltd.
Authorization Holder 9.5 km, Sheikhupura Road, Lahore, Pakistan
Name, address of Manufacturing site. M/s PDH Laboratories Pvt Ltd.
9.5 km, Sheikhupura Road, Lahore, Pakistan
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Temol Suspension 120mg/5ml
Pharmaceutical ingredient (API) per unit Paracetamol…….120mg
Pharmaceutical form of applied drug Clear, viscous liquid light orange to orange colour
Proposed Pack size 1’s x 60ml
The status in reference regulatory authorities Paracetamol 120 mg/5 ml Oral Suspension by
Pinewood Laboratories Limited, Ireland of MHRA
approved.
For generic drugs (me-too status) Calpol Pediatric Suspension of M/s
GlaxosmithKline Pakistan. No.000354
GMP status of the Finished product manufacturer Copy of cGMP certificate on the basis of
Evaluation conducted on 04-01-2022 and valid for
two years.
Name and address of API manufacturer. M/s Saakh Pharma (Pvt) Ltd
Address: C-7/1, Nwiz, Port Qasim Karachi.
Module III (Drug Substance) Official monograph of
Paracetamol(Actaminophen) is present in USP.
The firm as submitted detail of nomenclature,
form, manufacturers, description of
manufacturing process and controls, tests for
impurity, specifications, analytical procedures and
substance
months
months
Batches: (21GN60001, 21GN60002,
21GN60003)
and its verification studies, batch analysis and
drug product.
dissolution profile the brand that is Calpol Suspension by M/s GSK
Batch # 372R by performing quality tests
(description, Identification, pH, Deliverable
Volume, Viscosity, Microbial Enumeration,
Assay)
product including accuracy, precision, specificity.
Manufacturer of API M/s Saakh Pharma (Pvt) Ltd
API Lot No. 21GN60187
Description of Pack Clear, viscous liquid light orange to orange colour sweet in taste filled in
(Container closure system) ambered glass bottle of USP type III sealed with Aluminium cap, neatly
labelled and packed in a unit carton with insertion of a leaflet
Real Time: 0, 3, 6, 9, 12 (Months)
Batch No. T-006 T-007 T-008
Batch Size 40 bottles 40 bottles 40 bottles
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of cGMP certificate on the basis of
manufacturer issued by concerned regulatory evaluation conducted on 07-10-2022 and valid for
authority of country of origin. 02 years.
chromatograms, chromatograms, raw data sheets, COA, summary
Raw data sheets, COA, summary data sheets etc. data sheets etc.
6. Record of Digital data logger for temperature and The firm has submitted Record of Digital data
humidity monitoring of stability chambers (real logger for temperature and humidity monitoring
time and accelerated) of stability chambers (real time and accelerated).
1. 3.2.S.4.3 In Drug Substance Precision parameter of Analytical method verification is not
conducted as per ICH Q2(R1) guidelines. Which states “a minimum of 9 determinations
covering the specified range for the procedure (e.g., 3 concentrations/3 replicates each)
while you have used 6 determinations (3 concentrations /2 replicates each).
2. 3.2.P.2.2.1 In Pharmaceutical Equivalence Test product is tested on USP specifications while GSK
product (Reference/Comparator) tested on BP Specifications. Clarify why different
specifications are used.
3. 3.2.P.5.2 In Assay final concentrations is 0.01mg/ml while 96 mg of paracetamol from oral
suspension taken. Clarify how from 96mg 0.01mg/ml concentration prepared.
4. 3.2.P.5.3 In Drug Product Precision parameter of Analytical method verification is not conducted
as per ICH Q2(R1) guidelines. Which states “a minimum of 9 determinations covering
the specified range for the procedure (e.g., 3 concentrations/3 replicates each) while
you have used 6 determinations (3 concentrations /2 replicates each).
5. 3.2.P.8 Purchase Documents for Paracetamol.
Compliance Record of HPLC software 21CFR & audit trail reports on product testing
issued to the firm, hence Board deferred the case for submission of reply to the above cited shortcomings
within six months.
Evaluation:
S. Section Shortcomings Communicated Reply
No
1. 3.2.S.4.3 In Drug substance Precision parameter of The revised precision parameter of
Analytical method verification is not analytical method verification of drug
conducted as per ICH Q2(R1) guidelines. substance is attached.
Which states “a minimum of 9
determinations covering the specified
range for the procedure (e.g., 3
concentrations/3 replicates each) while you
have used 6 determinations (3
concentrations /2 replicates each).
2. 3.2.P.2.2.1 In Pharmaceutical Equivalence Test The testing of reference product was
product is tested on USP specifications performed as per claimed product
while GSK product specifications (BP Specs). Temol
(Reference/Comparator) tested on BP suspension was built on USP
Specifications. Clarify why different specifications during the product
specifications are used. development phase. However revised
pharmaceutical equivalence according
USP specifications is submitted.
3. 3.2.P.5.2 In Assay final concentrations is 0.01mg/ml It was typo error. The revised analytical
while 96 mg of paracetamol from oral method is submitted. 100mg of
suspension taken. Clarify how from 96mg paracetamol from oral suspension taken.
0.01mg/ml concentration prepared.
4. 3.2.P.5.3 In Drug Product Precision parameter of The revised precision parameter of
Analytical method verification is not analytical method verification of drug
conducted as per ICH Q2(R1) guidelines. product is submitted.
Which states “a minimum of 9
concentrations/3 replicates each) while you
have used 6 determinations (3
concentrations /2 replicates each).
5. 3.2.P.8  Purchase Documents for Paracetamol.  The API was locally purchased.
 Compliance Record of HPLC software Purchased documents of paracetamol
21CFR & audit trail reports on are attached. (Invoice
product testing #PRT/2021/0185 dated: 29-07-2021)
 Compliance record of HPLC software
21 CFR & audit trail reports on
product testing
Decision: Deferred for following clarifications:
 Manufacturing facility along with details of equipmentswherein the trial batches have been
manufactured along with evidence of approval of required manufacturing facility from CLB.
 Scientific rationale for selecting the batch size of 40 bottles for manufacturing of trial batches, along
with the submission of complete record of no. of bottles used in analytical testing of trial batches of
finished product at different time points of stability studies.
426. Name, address of Applicant / Marketing M/s PDH Laboratories Pvt Ltd.
Authorization Holder 9.5 km, Sheikhupura Road, Lahore, Pakistan
Name, address of Manufacturing site. M/s PDH Laboratories Pvt Ltd.
9.5 km, Sheikhupura Road, Lahore, Pakistan
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Temol DS Suspension 250mg/5ml
Pharmaceutical ingredient (API) per unit Paracetamol…….250mg
Pharmaceutical form of applied drug Clear, viscous liquid light orange to orange colour
Proposed Pack size 1’s x 60ml
The status in reference regulatory authorities Paracetamol 250 mg/5 ml Oral Suspension by
Pinewood Laboratories Limited, Ireland of MHRA
approved.
For generic drugs (me-too status) Calpol 6 plus Suspension of M/s GlaxosmithKline
Pakistan. No.000354
GMP status of the Finished product manufacturer Copy of cGMP certificate on the basis of
Evaluation conducted on 04-01-2022 and valid for
two years.
Name and address of API manufacturer. M/s Saakh Pharma (Pvt) Ltd
Module III (Drug Substance) Official monograph of
Paracetamol(Actaminophen) is present in USP.
form, manufacturers, description of
impurity, specifications, analytical procedures and
substance
months
months
Batches: (21GN60001, 21GN60002,
21GN60003)
drug product.
dissolution profile the brand that is Calpol 6 Plus Suspension by M/s
GSK Batch # 372R by performing quality tests
(description, Identification, pH, Deliverable
Volume, Viscosity, Microbial Enumeration,
Assay)
product including accuracy, precision, specificity.
Manufacturer of API M/s Saakh Pharma (Pvt) Ltd
API Lot No. 21GN60187
Description of Pack Clear, viscous liquid light orange to orange colour sweet in taste filled in
(Container closure system) ambered glass bottle of USP type III sealed with Aluminium cap, neatly
labelled and packed in a unit carton with insertion of a leaflet
Batch No. T-007 T-008 T-009
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of cGMP certificate on the basis of
manufacturer issued by concerned regulatory evaluation conducted on 07-10-2022 and valid for
authority of country of origin. 02 years.
humidity monitoring of stability chambers (real logger for temperature and humidity monitoring
time and accelerated) of stability chambers (real time and accelerated).
1. 3.2.S.4.3 In Drug substance Precision parameter of Analytical method verification is not
conducted as per ICH Q2(R1) guidelines. Which states “a minimum of 9
determinations covering the specified range for the procedure (e.g., 3 concentrations/3
replicates each) while you have used 6 determinations (3 concentrations /2 replicates
each).
2. 3.2.P.2.2.1 In Pharmaceutical Equivalence Test product is tested on USP specifications while GSK
product (Reference/Comparator) tested on BP Specifications. Clarify why different
specifications are used.
3. 3.2.P.5.3 In Drug Product Precision parameter of Analytical method verification is not conducted
as per ICH Q2(R1) guidelines. Which states “a minimum of 9 determinations covering
the specified range for the procedure (e.g., 3 concentrations/3 replicates each) while
you have used 6 determinations (3 concentrations /2 replicates each).
4. 3.2.P.8 Purchase Documents for Paracetamol.
Compliance Record of HPLC software 21CFR & audit trail reports on product testing
issued to the firm, hence Board deferred the case for submission of reply to the above cited shortcomings
within six months.
Evaluation:
1. 3.2.S.4.3 In Drug substance Precision The revised precision parameter of analytical
parameter of Analytical method method verification of drug substance is
verification is not conducted as per attached.
ICH Q2(R1) guidelines. Which
states “a minimum of 9
determinations covering the
specified range for the procedure
(e.g., 3 concentrations/3 replicates
each) while you have used 6
determinations (3 concentrations /2
replicates each).
2. 3.2.P.2.2.1 In Pharmaceutical Equivalence The testing of reference product was performed
Test product is tested on USP as per claimed product specifications (BP
specifications while GSK product Specs). Temol suspension was built on USP
(Reference/Comparator) tested on specifications during the product development
BP Specifications. Clarify why phase. However revised pharmaceutical
different specifications are used. equivalence according USP specifications is
submitted.
3. 3.2.P.5.3 In Drug Product Precision The revised precision parameter of analytical
parameter of Analytical method method verification of drug product is
verification is not conducted as per submitted.
ICH Q2(R1) guidelines. Which
states “a minimum of 9
each) while you have used 6
determinations (3 concentrations /2
replicates each).
4. 3.2.P.8  Purchase Documents for  The API was locally purchased. Purchased
Paracetamol. documents of paracetamol are attached.
 Compliance Record of HPLC (Invoice #PRT/2021/0185 dated: 29-07-
software 21CFR & audit trail 2021)
reports on product testing  Compliance record of HPLC software 21
CFR & audit trail reports on product testing
Decision: Deferred for following clarifications:
 Manufacturing facility along with details of equipments wherein the trial batches have been
manufactured along with evidence of approval of required manufacturing facility from CLB.
 Scientific rationale for selecting the batch size of 40 bottles for manufacturing of trial batches, along
with the submission of complete record of no. of bottles used in analytical testing of trial batches of
finished product at different time points of stability studies.
M/s Crystolite Pharmaceuticals. (New Section)
CLB in its 290th meeting held on 28th April 2023, has approved the following 04 additional sections
of M/s Crystolite Pharmaceuticals.
1. Dry Vial Section ( Cephalosporin )

2. Dry Vial Section ( Carbapenem)
3. Oral Dry Powder Suspension Section (Cephalosporin)
4. Capsule Section ( Cephalosporin )

th
consideration in 330 consideration in 330th
meeting meeting
1 Dry Vial Section ( Carbapenem) 03 05
427. Name and address of manufacturer / M/s Crystolite Pharmaceuticals.
Applicant Plot # 1 & 2, Street S-2, National Industrial Zone, Rawat,
Islamabad
Brand Name +Dosage Form + Strength Erapam 1gm Powder for concentrate for solution for
infusion
Ertapenem…….1gm
Diary No. Date of R& I & fee Dy.No 8218 dated 25-02-2019 Rs.20,000/- Dated 25-02-
2019
Type of Form Form 5
Finished product Specifications Manufacturer specifications
Pack size & Demanded Price 1’s: As per SRO
Approval status of product in Reference INVANZ (ertapenem for injection) for intravenous (IV)
Regulatory Authorities or intramuscular (IM) use by M/s Merck Sharp &
Dohme USA (USFDA Approved)
Me-too status Ernem Injection of M/s Genix Pharma,
(Reg.# 081179)
GMP status Inspection date 13/07/2018, panel recommend grant of
DML
Remarks of the Evaluator  Approval of section/manufacturing facility
(carbapenem section) by the Central Licensing Board.
 In reference as sodium while applied without sodium
clarify, otherwise revise your formulation with
submission of applicable fee
Previous Decision (M-324): Deferred for submission of evidence of approval of required
manufacturing facility i.e., Dry powder injection (Carbapenem) section from CLB or else while firm
may transfer the registration application to by way of contract manufacturing upon submission of Form
5F, within six months.
Evaluation by PEC:
Firm submitted section approval letter dated:12-07-2023 for Dry Vial Injection Section (Carbapenem)
Decision: Approved with innovator’s specifications as per following label claim:
“Each Vial Contains:
Ertapenem as sodium…….1gm”
Firm shall submit fee of Rs. 30,000/- for pre-approval correction/change in salt form of rug
substance, before issuance of registration letter.
Islamabad
Brand Name +Dosage Form + Strength Cinipem IV 250mg/250mg Powder for solution for
infusion
Imipenem (as 265mg Imipenem
Monohydrate)..……..250mg
Cilastatin (as 265mg cilastatin sodium
salt)…………250mg
(Sterile mixture also contains sodium bicarbonate as
buffer)
2019
Type of Form Form-5
Finished product Specifications USP
Pack size & Demanded Price 1’s; As per SRO
Approval status of product in Reference PRIMAXIN® (imipenem and cilastatin)
Regulatory Authorities for Injection, For intravenous use. USFDA
approved
Me-too status Cilapen 250mg Injections of M/s Bosch
Pharmaceuticals,
DML
Remarks of the Evaluator Approval of section/manufacturing facility ( carbapenem
section) by the Central Licensing Board.
Evaluation by PEC:
Decision: Approved.
Islamabad
Brand Name +Dosage Form + Strength Cinipem IV 500mg/500mg Powder for solution for
infusion
Imipenem (as 530mg Imipenem
Monohydrate)..……..500mg
Cilastatin (as 530mg cilastatin sodium
salt)…………500mg
(Sterile mixture also contains sodium bicarbonate as
buffer)
2019
Type of Form Form-5
Approval status of product in Reference PRIMAXIN® (imipenem and cilastatin)
Regulatory Authorities for Injection, For intravenous use. USFDA
approved
Me-too status Cilapen 500mg Injections of M/s Bosch
Pharmaceuticals,
DML
Evaluation by PEC:
Decision: Approved.
Islamabad
Brand Name +Dosage Form + Strength Merolite 500mg Powder for solution for injection or
infusion
Meropenem (as 570.78mg Meropenem Trihydrate eq to
Anhydrous Meropenem)….. ………500mg
(with anhydrous Sodium Carbonate)
2019
Type of Form Form-5
Approval status of product in Reference MERREM® IV (meropenem for injection) 500mg, for
Regulatory Authorities intravenous use. US-FDA approved
Me-too status Olver Injection of M/s Genix
DML
Evaluation by PEC:
Decision: Approved
Registration letter will be issued after submission of evidence of Atomic absorption
spectrophotometer along with its IQ, OQ and PQ reports.
Islamabad
Brand Name +Dosage Form + Strength Merolite 1g Powder for solution for injection or infusion
Meropenem (as 1141.56mg Meropenem Trihydrate eq to
Anhydrous Meropenem) …… 1g
(with anhydrous Sodium Carbonate)
2019
Type of Form Form-5
Approval status of product in Reference MERREM® IV (meropenem for injection) 1g, for
Regulatory Authorities intravenous use. US-FDA approved
Me-too status Olver Injection of M/s Genix
DML
Evaluation by PEC:
Decision: Approved. Registration letter will be issued after submission of evidence of atomic
absorption spectrophotometer along with its IQ, OQ and PQ reports.
Case no. 05 Registration applications of categories to be considered on priority

a. Local manufacturing applications of priority categories defined by Registration Board in
its 257th meeting
Deferred case:
432. Name, address of Applicant / Marketing M/s OPHTH PHARMA (PVT.) LTD.
Authorization Holder Plot No. 241, Sector-24, 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
☐Generic Drug Product (GDP)
☐ Export sale
Dy. No. and date of submission Dy. No 7346 dated 15/03/2022
The proposed proprietary name / brand PRIMLA (Topical Cream 5%)
name
Strength / concentration of drug of Active Each gram of cream contains:
Pharmaceutical ingredient (API) per unit Lidocaine Base USP.... 25mg
Prilocaine Base USP… 25mg
Pharmaceutical form of applied drug Topical Cream
Pharmacotherapeutic Group of (API) Local Anesthetics
specifications
Proposed Pack size 30 gm
The status in reference regulatory LIDOCAINE AND PRILOCAINE Cream of M/s
authorities Tolmar Inc of USFDA approved
GMP status of the Finished product cGMP certificate on the basis of Evaluation conducted
manufacturer 0n 27 -09-2021 and valid for 2 years.
(Section Sterile Eye Ointment/Topical Cream
mentioned)
Name and address of API manufacturer. Lidocaine and Prilocaine : Shandong Chengui Shuangda
Pharmaceutical Co., ltd.
Address: Economic Development zone, Pingyuan
County, Dezhou City, Shandong Province253100,
China Shandong Chengui Shuangda Pharmaceutical
Co., ltd.
nomenclature, structure, general properties, solubility’s,,
submitted.
Module III (Drug Substance) Lidocaine: Official monograph of Lidocaine is present
in USP. The firm has submitted detail of nomenclature,
structure, general properties, solubility’s,, physical
process and controls, tests for impurities, specifications,
substance
Prilocaine :
Official monograph of Prilocaine is present in USP. The
firm has submitted detail of nomenclature, structure,
general properties, solubility’s,, physical form,
and controls, tests for impurities & related substances,
stability studies of drug substance
Lidocaine: Real time: 30°C ± 2°C / 65% ± 5%RH for 24
months
Batches: (17050301, 17061502, 17062203)
Prilocaine :
Batches: (16091101, 16091702, 16092303)
Pharmaceutical equivalence and Pharmaceutical Equivalence have been established
comparative dissolution profile against the Emla Topical cream by performing quality
tests (Appearance, Identification, pH, Fill volume Drug
Release ).
Analytical method validation/verification Method verification studies have submitted including
of product linearity, accuracy, precision, specificity, robustness.
Manufacturer of API Lidocaine and Prilocaine : Shandong Chengui Shuangda Pharmaceutical Co., ltd.
Address: Economic Development zone, Pingyuan County, Dezhou City,
Shandong Province253100, China Shandong Chengui Shuangda Pharmaceutical
Co., ltd.
API Lot No. Lidocaine: 21081605
Prilocaine : 21091206
Description of Pack
(Container closure Aluminium Tube
system)
Stability Storage Real time: 30°C ± 2°C / 65% ± 5%RH
Condition Accelerated: 40°C ± 2°C / 75% ± 5%RH
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. TB-101 TB-102 TB-103
Batch Size 3Kg (100 Tubes) 3Kg (100 Tubes) 3Kg (100 Tubes)
No. of Batches 03
1. Reference of previous approval of
firm (if any)
2. Approval of API/ DML/GMP certificate of
regulatory authority of country of origin.
3. Documents for the procurement of API
with approval from DRAP (in case of
import).
4. Data of stability batches will be supported Submitted
by attested respective documents like
chromatograms,
Raw data sheets, COA, summary data
sheets etc.
testing
6. Record of Digital data logger for Submitted
temperature and humidity monitoring of
stability chambers (real time and
accelerated)
certificate of the Drug Substance manufacturer issued by the relevant regulatory authority
of country of origin.
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.4.2 Copies of the Drug substance specifications and analytical procedures used for routine
testing of the both Drug substance /Active Pharmaceutical Ingredient (Lidocaine and
Prilocaine) 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
(Lidocaine and Prilocaine) shall be submitted.
5. 3.2.P.2.2.1  Details , origin and procurement documents of product against which Pharmaceutical
equivalence is established.
 Assay was not conducted of both test product and reference product in Pharmaceutical
equivalence. Clarification is required.
 Provide reference of Drug release performed in Pharmaceutical equivalence.
6. 3.2.P.3.5 A brief description of process validation including the proposed protocol shall be
Submitted.
7. 3.2.P.5.1 Microbial Enumeration tests and test for specified organism is not included in specification
however USP monograph include these tests.
8. 3.2.P.8  Approval of API/ DML/GMP certificate of API manufacturer issued by concerned
regulatory authority of country of origin Documents for the procurement of API with
approval from DRAP.
 Date of Initiation of stability study.
 Compliance Record of HPLC software 21CFR & audit trail reports on product testing
Previous Decision: Registration Board was apprised that the letter of shortcoming has been initially issued to
the firm, hence Board deferred the case for submission of reply to the above cited shortcomings within six
months.
S.N Section Shortcomings Communicated Reply
o
1. 1.6.5 Valid Drug Manufacturing License or Firm has submitted copy of DML (Lu20170365)
Valid Good Manufacturing Practice dated 12-10-2022 issued by Shandong Drug
(GMP) certificate of the Drug administration China. Valid till 11/10/2027.
Substance manufacturer issued by the
relevant regulatory authority of country
of origin.
2. 2.3.R.1.1 Provide copy of Batch Manufacturing Batch Manufacturing Record (BMR) for all the
Record (BMR) for all the batches of batches of drug product for which stability
drug product for which stability studies studies data is provided in Module 3 section is
data is provided in Module 3 section submitted.
3.2.P.8.3
3. 3.2.S.4.2 Copies of the Drug substance Copies of the Drug substance specifications and
specifications and analytical procedures analytical procedures used for routine testing of
used for routine testing of the both Drug the both Drug substance /Active Pharmaceutical
substance /Active Pharmaceutical Ingredient (Lidocaine and Prilocaine) by Drug
Ingredient (Lidocaine and Prilocaine) Product manufacturer are submitted.
by Drug Product manufacturer is
required.
4. 3.2.S.4.3 Analytical Method Verification studies Analytical Method Verification studies
including specificity, accuracy and including specificity, accuracy and repeatability
repeatability (method precision) (method precision) performed by the Drug
performed by the Drug Product Product manufacturer for drug substance
manufacturer for drug substance (Lidocaine and Prilocaine submitted.
(Lidocaine and Prilocaine) shall be
submitted.
5. 3.2.P.2.2.1  Details , origin and procurement  Emla Topical cream by Aspen pharma used
documents of product against for pharmaceutical Equivalence.
which Pharmaceutical equivalence  Revised pharmaceutical equivalence with
is established. assay submitted.
 Assay was not conducted of both
test product and reference product
in Pharmaceutical equivalence.
6. 3.2.P.3.5 A brief description of process A brief description of process validation
validation including the proposed including the proposed protocol Submitted.
protocol shall be Submitted.
7. 3.2.P.5.1 Microbial Enumeration tests and test Revised specification with microbial
for specified organism is not included in enumeration tests and test for specified
specification however USP monograph organism submitted.
include these tests.
8. 3.2.P.8  Documents for the procurement of  Commercial Invoice # 30112018 dated 30-
API with approval from DRAP. 11-2018 approved by DRAP Karachi dated:
 Date of Initiation of stability study. 31-12-2018 submitted.
 Compliance Record of HPLC  Date of Initiation of stability study.
software 21CFR & audit trail  Submitted
reports on product testing  Submitted.
 Record of Digital data logger for
temperature and humidity
monitoring of stability chambers
Decision: Approved.
b. Export facilitation
Export Facilitation: Applications was received through letter No.F.1-6/2019-PR-I (EFD)
“ M/s Focus & Rulz Pharmaceuticals Pvt Ltd. Islamabad have achieved benchmark of USD 533,670.4 as
defined in the Board’s decision during fiscal year 2021-2022. In this regard, please find the (1 molecule) 01
products applications submitted by the firm.”
433. Name, address of Applicant / Marketing M/s Focus & Rulz Pharmaceuticals Pvt Ltd.
Authorization Holder 44-Industrial Triangle Kahuta Road, Islamabad
Name, address of Manufacturing site. M/s Focus & Rulz Pharmaceuticals Pvt Ltd.
44-Industrial Triangle Kahuta Road, Islamabad
☐ Importer
☐ Export sale
The proposed proprietary name / brand name M-Fer Drops 50mg/ml
Strength / concentration of drug of Active Each ml Contains:
Pharmaceutical ingredient (API) per unit Iron III Hydroxide Polymaltose Complex
Equuvalent to elemental iron……50mg
Pharmaceutical form of applied drug Film coated Tablet
Pharmacotherapeutic Group of (API) Iron Supplement (Iron Prepartion)
Reference to Finished product specifications Innovator specification
The status in reference regulatory authorities MALTOFER DROPS by Vifor Pharma Pty Ltd,
TGA Approved.
For generic drugs (me-too status) RubiferOral Drops 50mg/ml by M/s AGP Pvt.
.Ltd., Reg# 031051
GMP status of the Finished product manufacturer cGMP certificate on the basis of Evaluation
conducted on 29-12-2020 and valid for two (02)
years
Name and address of API manufacturer. Chemiworld Pvt. Ltd. Plot No. 97, J- Industrial
Estate Jamrud Peshawar Pakistan.
impurities, specifications, analytical procedures
and its verification, batch analysis and justification
of specification, reference standard, container
substance and drug product is submitted.
Module III (Drug Substance) Official monograph of Iron III Hydroxide
Polymaltose Complex is not present in any
pharmacopeia. The firm as submitted detail of
drug substance
months
months
Batches: (106-IPC-001, 106-IPC-002, 106-IPC-
003)
drug product.
dissolution profile against the Rubifer Oral by AGP Ltd by
performing quality tests (Physical Appearance,
identification, Color, pH, Assay).
Manufacturer of API Chemiworld Pvt. Ltd. Plot No. 97, J- Industrial Estate Jamrud Peshawar
Pakistan.
API Lot No. A21-IPC-473
Description of Pack
Amber colored bottles
Batch No. 21DT05 21DT06 21DT07
Batch Size 200 Bottles 200 Bottles 200 Bottles
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API The firm has submitted copy of GMP Certificate #
manufacturer issued by concerned regulatory F.3-20/2017-DRAP-90 on the basis of inspection
authority of country of origin. 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.
3. Documents for the procurement of API with Copy of Invoice # 2909 Dated:02-02-2021 from
approval from DRAP (in case of import). chemiworld Pvt Ltd specifying Polymaltose
complex Batch # A21-IPC-473
5. Compliance Record of HPLC software 21CFR & Titration is used.
humidity monitoring of stability chambers (real logger for temperature and humidity monitoring of
time and accelerated) stability chambers (real time and accelerated).
8. 1.6.5 Valid Drug Manufacturing The firm has submitted copy of GMP Certificate
License or Valid Good # F.3-20/2017-DRAP-90 on the basis of
Manufacturing Practice (GMP) inspection conducted on 29-11-2016 for M/S
certificate of the Drug Chemiworld Pvt. Ltd. issued by DRAP. The
Substance manufacturer issued firm has submitted application for issuance of
by relevant regulatory authority new GMP certificate.
9. 2.3.R.1.1 Provide copy of Batch Batch Manufacturing Record (BMR) for all the
Manufacturing Record (BMR) batches of drug product for which stability
for all the batches of drug studies data is provided in Module 3 section
product for which stability 3.2.P.8.3 submitted.
10. 3.2.S.4.3 Analytical Method Verification Analytical Method Verification studies including
studies including specificity, specificity, accuracy and repeatability (method
accuracy and repeatability precision) performed by the Drug Product
(method precision) performed manufacturer drug substance(s) submitted
by the Drug Product
manufacturer drug substance(s)
shall be submitted.
11. 3.2.P.5.2 Certificate of Analysis (CoA) Certificate of Analysis (CoA) of the same batch
of the same batch from Drug from Drug Substance / /Active Pharmaceutical
Substance / /Active Ingredient manufacture and drug product
Pharmaceutical Ingredient manufacturer submitted.
manufacture.
12. 3.2.S.5 Certificate of analysis of Valid Certificate of Analysis of reference
reference standard show standard submitted.
validity up to Feb 2015
13. 3.2.P.5.2 In assay 10ml Syrup contains We have our registered product for Iron
100mg of iron. Clarify how polymaltose (M-Fer Syrup), and the Standard
10ml contains 100mg of Iron operating for Iron ploy maltose syrup was
while applied formulations provided mistakenly in Module 3.2.P.5.2 of the
contains 50mg/ml. CTD instead of Iron polymaltose drops. We
apologies for the mistaken and revised SAP is
enclosed.
14. 3.2.P.5.3 Analytical method validation of We have our registered product for Iron
different product submitted i.e polymaltose (M-Fer Syrup), and the Analytical
that is syrup. Submit Analytical method validation for Iron ploy maltose syrup
method validation of 50mg/ml was provided mistakenly in Module 3.2.P.5.2 of
drops. the CTD instead of Iron polymaltose drops. We
apologies for the mistaken and revised
Analytical method validation is enclosed
15. 3.2.P.8 Purchase documents for Iron Purchase documents for Iron III Hydroxide
III Hydroxide Polymaltose Polymaltose Complex submitted.
Complex.
Decision: Approved.
 Registration letter will be issued upon submission of Rs. 7,500/- fee for revision of specifications as per
notification No.F.7-11/2021-B&A/DRAP dated 07-05-2021.
Agenda of Evaluator PEC-IX

Case No. 1: New DML and New sections
The Central Licensing Board in its 289th meeting approved following new sections of M/s Getz Pharma (Pvt) Ltd
(DML No. 000933 dated 20-05-2021);
i. Tablet (Cephalosporin)
ii. Capsule (Cephalosporin)
iii. Dry Powder Suspension (Cephalosporin)
iv. Dry Powder Vial Injection (Cephalosporin)
v. Product development laboratory (Cephalosporin)
vi. Warehouse (Cephalosporin)
vii. Quality Control Laboratory (Cephalosporin)
434. Name, address of Applicant / Marketing M/s. Getz Pharma (Pvt.) ltd. (DML No. 000933)
Authorization Holder Plot No. 1, Sector 25, Korangi Industrial Area,
Karachi.
Name, address of Manufacturing site. M/s. Getz Pharma (Pvt.) ltd. (DML No. 000933)
Plot No. 1, Sector 25, 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. 13166 dated 29.05.2023.
Details of fee submitted PKR 30,000/- vide slip No. 02532889343 dated
19.01.2023
The proposed proprietary name / brand name Primget 250mg (IM/IV) Powder for Injection
Strength / concentration of drug of Active Each vial contains;
Pharmaceutical ingredient (API) per unit Sterile Cefepime HCl with L-Arginine equivalent to
Cefepime…………250mg
Pharmaceutical form of applied drug White to off-white powder, filled in clear glass USP
type II vial with blue coloured flip-off seal on top of
grey coloured rubber stopper.
Supplied with 5ml sterile water for injection.
Pharmacotherapeutic Group of (API) Fourth generation cephalosporin.
ATC Code: J01DE01
Reference to Finished product specifications USP Specifications
The status in reference regulatory authorities Could not be verified for 250mg strength.
For generic drugs (me-too status) Cefstar Powder for Injection 250mg Reg No. 076005
M/s Barrett Hodgson Pakistan (Pvt.) Ltd.
GMP status of the Finished product Manufacturer: M/s. Getz Pharma (Pvt.) ltd. Plot No.
manufacturer 1, Sector 25, Korangi Industrial Area, Karachi.
New section granted in February 2023.
Evidence of section approval. Dry Powder Vial Injection (Cephalosporin) issued
vide letter No. F.2-9/2014-Lic (Vol-I) dated
27.02.2023.
Name and address of API manufacturer. M/s NCPC Hebei Huamin Pharmaceutical Co. Ltd.
No. 18, Yangzi Road, Economic & Technological
Development Zone Shijiazhuang.
Copy of GMP certificate No. HE20190059 dated
11.06.2019, issued by Hebei Drug Administration,
valid till 10.06.2024 is submitted.
verification / validation, batch analysis and
structure, general properties (solubility & physical
form), general properties of drug pellets., description
related. Any other Individual unspecified impurity,
Total Impurities, specifications, analytical procedures
Batches: H2231608001, H2231608002,
H2231608003
Module-III (Drug Product): The firm has submitted detail of the description and
composition of the drug product, manufacturers,
Process validation, specifications, analytical
procedure and its verification studies, batch analysis
product.
Pharmaceutical equivalence and comparative Test product: Cefepime IV/IM Powder for
dissolution profile Injection 250mg Batch No. C010DS01 Mfg 09.2022
Exp 09.2024.
Reference Product: CefStar Injection 250mg, Batch
No. D2521, Mfg date: Jul-2022, Exp. Date: June 2024.
of M/s Barrett Hodgson Pakistan. (Images of Pack are
provided)
Pharmaceutical Equivalence is established against the
comparator CefStar Injection 250mg, Batch No.
D2521, Mfg date: Jul-2022, Exp. Date: June 2024.
of M/s Barrett Hodgson Pakistan by performing
quality tests (Physical attributes, Identification, Assay,
Uniformity of dosage unit, water content, pH test and
related substances).
Results of both the products are comparable with each
other.
Analytical method validation/verification of Method verification studies are submitted including
product specificity, linearity and range.
Manufacturer of API M/s NCPC Hebei Huamin Pharmaceutical Co. Ltd. No. 18, Yangzi Road,
Economic & Technological Development Zone Shijiazhuang.
API Lot No. H2232207001
Description of Pack
White to off-white powder, filled in a clear glass USP type II Vial.
Time Period Real time: 0, 3, 6 months
Accelerated: 0, 3, 6 months
Batch No. C010DS01 C010DS02 -
Batch Size 2000 vials 2000 vials -
Manufacturing Date 09.2022 09.2022 -
Date of Initiation 11.10.2022 11.10.2022 -
No. of Batches 02 batches
7. Reference of previous approval of applications Not Submitted.
with stability study data of the firm (if any) The applications are of new sections. There are no
previous registrations in these sections.
8. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. HE20190059 dated
API manufacturer issued by concerned 11.06.2019 in the name of M/s NCPC Hebei Huamin
regulatory authority of country of origin. Pharmaceutical Co. Ltd. No. 18, Yangzi Road,
Economic & Technological Development Zone
Shijiazhuang, issued by Hebei Drug Administration,
9. Documents for the procurement of API with Drug Substance: Cefepime Hydrochloride (L-
approval from DRAP (in case of import). Arginine)
Batch No.: H2232207001
Mfg. Date: 10.07.2022
Exp. Date: 06.2024
Quantity: 20Kg
Invoice No.: 20220602-2 dated: 24.08.2022

chromatograms,
Raw data sheets, COA, summary data sheets
etc.
Sr. Section Observation Reply by the firm
No.
1. 1.5.9 RRA could not be verified for strength The firm vide letter No. RA-QL/316/0723
of 250mg dated 07.07.2023 has submitted following
justification;
“This is to inform you that Cefepime
Injection 250mg is available in local market
with the brand name of CefStar Injection
250mg (Reg. No.: 076005) manufactured by
M/s Barrett Hodgson Pakistan (Pvt.) Ltd
since December 2013. Further, this is to
inform you that 250mg is the lowest strength
while its higher strengths i.e., 500mg, 1g
and 2g are already approved by RRAs as
notified by DRAP. Considering availability
and approval of 250mg by DRAP and
higher strengths by RRAs / DRAP, it is
evident that 250mg strength is safe.”
2. 1.6.5 The list of API given in GMP The firm has submitted a copy of letter of
certificate of API manufacturer Hebei Food and drug administration China
doesn’t mention that Cefepime HCl that indicates approval for manufacturing of
will be with L-Arginine. Cefepime dihydrochloride with L-Arginine.
3. 3.2.S.4.5 In justification of specifications,API The firm has stated that name of Cefepime
name is mentioned as Cefepime as per USP, BP and Ph. Eur. is as follows;
dihydrochloride L arginine. Is it USP: Cefepime Hydrochloride.
dihydrochloride or BP: Cefepime Hydrochloride monohydrate
monohydrochloride? At other points Ph. Eur: Cefepime Dihydrochloride
its only mentioned as hydrochloride, monohydrate.
the USP reference standard is also of There is only difference in the naming of
Cefepime hydrochloride. said API among different pharmacopoeias
while there is no change in molecular
formula or molecular weight.
The reply of firm is verifiable.
4. Documents for the procurement of Submitted.
API with approval from DRAP
(Import license and AD attested
invoice) are required.
5. 3.2.P.8 For drug product, stability studies data The firm has submitted complete stability
of only 3 months is submitted. data for 6 months vide letter No. RA-
Stability studies data of 6 months is SD/280/0623 dated 21.06.2023
required.
Deferred for evidence of approval of applied formulation in reference regulatory authorities / agencies
which were adopted by the Registration Board in its 275th meeting. The Board further decided that the
applicant shall submit the response within 1 month after publication of the minutes, .
Karachi.
Karachi.
☐ Importer
☐ Export sale
17.01.2023
The proposed proprietary name / brand name Primget 500mg (IM/IV) Powder for Injection
Cefepime…………500mg
ATC Code: J01DE01
For generic drugs (me-too status) Cefstar Powder for Injection 500mg Reg No. 030953
27.02.2023.
Batches: H2231608001, H2231608002,
H2231608003
product.
dissolution profile Injection 500mg Batch No. C011DS01 Mfg 09.2022
Exp 09.2024.
Reference Product: CefStar Injection 500mg, Batch
No. D3590, Mfg date: Oct-2022, Exp. Date: Sep 2025.
provided)
comparator CefStar Injection 500mg, Batch No.
D3590, Mfg date: Oct-2022, Exp. Date: Sep 2025.
other.
API Lot No. H2232207001
Description of Pack
Batch No.: H2232207001
Mfg. Date: 10.07.2022
Exp. Date: 06.2024
Quantity: 20Kg
Invoice No.: 20220602-2 dated: 24.08.2022
chromatograms,
etc.
No.
1. 1.6.5 The list of API given in GMP The firm has submitted reply vide letter No.
certificate of API manufacturer RA-QL/317/0723.
doesn’t mention that Cefepime HCl The firm has submitted a copy of letter of
will be with L-Arginine. Hebei Food and drug administration China
that indicates approval for manufacturing of
Cefepime dihydrochloride with L-Arginine.
2. 3.2.S.4.5 In justification of specifications, API The firm has stated that name of Cefepime
3. - Copy of AD attested invoice of API Submitted.
clearance is required.
4. 3.2.P.2 Justification shall be submitted for not The firm has stated that as per DRAP
performing Pharmaceutical guidelines “Guidance document for
equivalence studies against innovator submission of application on Form 5-F
product. (CTD) for registration of pharmaceutical
drug products for human use,” to perform
Pharmaceutical Equivalence ‘The
comparison of the developed formulation
and the innovator/ reference/ comparator
product including the results of all the
quality tests shall be submitted and
discussed.’
The firm has further stated that they have
established pharmaceutical equivalence
with comparator product as innovator brand
is currently not available in Pakistan.
required.
Decision: Registration Board approved the application of Primget 500mg (IM/IV) Powder for Injection.
• Manufacturer will place first three production batches on long term stability studies throughout
• Manufacturer will perform process validation of first three batches as per the commitment
Karachi.
Karachi.
☐ Importer
☐ Export sale
17.01.2023
The proposed proprietary name / brand name Primget 1g (IM/IV) Powder for Injection
Cefepime…………1g
ATC Code: J01DE01
For generic drugs (me-too status) Cefstar Powder for Injection 1g Reg No. 030954
27.02.2023.
Batches: H2231608001, H2231608002,
H2231608003
product.
dissolution profile Injection 1g Batch No. C012DS01 Mfg 09.2022 Exp
09.2024.
Reference Product: CefStar Injection 1g, Batch No.
D0675, Mfg date: June-2022, Exp. Date: May 2025.
provided)
comparator CefStar Injection 1g, Batch No. D0675,
Mfg date: June-2022, Exp. Date: May 2025.
other.
API Lot No. H2232207001
Description of Pack
The applications are of new sections. There are no
Batch No.: H2232207001
Mfg. Date: 10.07.2022
Exp. Date: 06.2024
Quantity: 20Kg
Invoice No.: 20220602-2 dated: 24.08.2022
chromatograms,
etc.
No.
discussed.’
required.
Decision: Registration Board approved the application of Primget 1g (IM/IV) Powder for Injection.
Karachi.
Karachi.
☐ Importer
☐ Export sale
17.01.2023
The proposed proprietary name / brand name Primget 2g (IM/IV) Powder for Injection
Cefepime…………2g
ATC Code: J01DE01
For generic drugs (me-too status) Maxum Powder for Injection 2g Reg No. 073339
M/s Highnoon Laboratories Ltd.
27.02.2023.
Batches: H2231608001, H2231608002,
H2231608003
product.
dissolution profile Injection 2g Batch No. C023DS01 Mfg 09.2022 Exp
09.2024.
Reference Product: Maxum Injection 2g, Batch No.
2180070, Mfg date: Apr-2021 Exp. Date: Mar 2023.
of M/s Highnoon limited. (Images of Pack are
provided)
comparator Maxum Injection 2g, Batch No. 2180070,
Mfg date: Apr-2021 Exp. Date: Mar 2023 of M/s
Highnoon limited by performing quality tests
(Physical attributes, Identification, Assay, Uniformity
of dosage unit, water content, pH test and related
substances).
other.
API Lot No. H2232207001
Description of Pack
Batch No.: H2232207001
Mfg. Date: 10.07.2022
Exp. Date: 06.2024
Quantity: 20Kg
Invoice No.: 20220602-2 dated: 24.08.2022
chromatograms,
etc.
No.
discussed.’
required.
Decision: Registration Board approved the application of Primget 2g (IM/IV) Powder for Injection.
Karachi.
Karachi.
☐ Importer
☐ Export sale
19.01.2023
The proposed proprietary name / brand name Getaclor 125mg/5ml Powder for Suspension
Strength / concentration of drug of Active Each reconstituted 5ml contains;
Pharmaceutical ingredient (API) per unit Cefaclor monohydrate equivalent to
Cefaclor ……………………………….125mg
Pharmaceutical form of applied drug Pink colour granular powder filled in white HDPE
plastic bottle with marked line on the bottle for
addition of water for reconstitution.
Packed in carton along with a packaging insert.
Pharmacotherapeutic Group of (API) Second generation cephalosporin
ATC Code: J01DC04
Reference to Finished product specifications BP Specifications
Proposed Pack size 1’s (60ml)
The status in reference regulatory authorities KEFTID 125MG/5ML SUSPENSION, CEFACLOR
125MG/5ML SUSPENSION
MHRA Approved.
For generic drugs (me-too status) Ceclor Powder for suspension 125mg/5ml
Reg No. 098676
M/s AGP Limited Karachi.
Evidence of section approval. Dry Powder Suspension (Cephalosporin) issued vide
letter No. F.2-9/2014-Lic (Vol-I) dated 27.02.2023.
Name and address of API manufacturer. M/s Zhejiang Dongbang Pharmaceutical Co. Ltd,
Pharm-Chem Zone, Duqiao Linhai, Taizhou, Zhejiang
China.
Copy of GMP certificate No. ZJ20190147 dated
30.11.2019, issued by National Medical Products
Administration, valid till 29.11.2024 is submitted.
Batches: DBC-1010-202108001, DBC-1010-
202108002, DBC-1010-202108003
product.
Pharmaceutical equivalence and comparative Test product: GETACLOR Powder for Suspension
dissolution profile 125mg/5ml Batch No. C001DS01 Mfg 09.2022 Exp
09.2024.
Reference Product: Ceclor Suspension 125mg/5ml
Batch No. A8189, Mfg date: Oct-2022 Exp. Date: Mar
2024.
of M/s AGP Limited. (Images of Pack are provided)
comparator Ceclor Suspension 125mg/5ml Batch No.
A8189, Mfg date: Oct-2022 Exp. Date: Mar 2024 of
M/s AGP Limited by performing quality tests
substances).
other.
Manufacturer of API M/s Zhejiang Dongbang Pharmaceutical Co. Ltd, Pharm-Chem Zone,
Duqiao Linhai, Taizhou, Zhejiang China
API Lot No. DBC-1010-202111017
Description of Pack
Pink granular powder filled in white HDPE plastic bottles.
Batch Size 2000 bottles 2000 bottles -
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. ZJ20190147 dated
API manufacturer issued by concerned 30.11.2019 in the name of M/s Zhejiang Dongbang
regulatory authority of country of origin. Pharmaceutical Co. Ltd, Pharm-Chem Zone, Duqiao
Linhai, Taizhou, Zhejiang China, issued by issued by
National Medical Products Administration, valid till
29.11.2024 is submitted.
3. Documents for the procurement of API with Drug Substance: Cefaclor USP 43
approval from DRAP (in case of import). Batch No.: DBC-1010-202111017
Mfg. Date: 27.11.2022
Exp. Date: 26.11.20240
Quantity: 35kg
Invoice No.: 20220602-1 dated: 29.07.2022.
chromatograms,
etc.
No.
1. 2.2 It is not clearly mentioned that what The firm vide letter No. RA-QR/324/0623
will be the colour of HDPE plastic dated 03.07.2023 has submitted that the
bottle, how will it be marked for colour of HDPE bottle is white with marked
addition of water for reconstitution. line on the bottle for addition of water for
This needs to be clearly mentioned. reconstitution.
required.
4. 3.2.P.8 In-use stability studies data is not Submitted.
provided. The product was kept at 2℃ to 8℃ after
reconstitution and was tested on 7th day and
14th day.
Results indicate that product remained
stable in above conditions for 14 days.
Decision: Registration Board approved the application of Getaclor 125mg/5ml Powder for Suspension.
Karachi.
Karachi.
☐ Importer
☐ Export sale
19.01.2023
The proposed proprietary name / brand name Getaclor 250mg/5ml Powder for Suspension
Cefaclor ……………………………….250mg
ATC Code: J01DC04
The status in reference regulatory authorities KEFTID 250MG/5ML SUSPENSION, CEFACLOR
250MG/5ML SUSPENSION
MHRA Approved.
For generic drugs (me-too status) Ceclor Powder for suspension 250mg/5ml
Reg No. 098678
China.
Batches: DBC-1010-202108001, DBC-1010-
202108002, DBC-1010-202108003
product.
Pharmaceutical equivalence and comparative Test product: GETACLOR Powder for Suspension
dissolution profile 250mg/5ml Batch No. C002DS01 Mfg 09.2022 Exp
09.2024.
Reference Product: Ceclor Suspension 250mg/5ml
Batch No. A8195, Mfg date: Oct-2022 Exp. Date: Mar
2024.
comparator Ceclor Suspension 250mg/5ml Batch No.
A8195, Mfg date: Oct-2022 Exp. Date: Mar 2024 of
M/s AGP Limited by performing quality tests
substances).
other.
API Lot No. DBC-1010-202111017
Description of Pack
Pink granular powder filled in HDPE plastic bottles.
The applications are of new sections. There are no
Mfg. Date: 27.11.2022
Exp. Date: 26.11.20240
Quantity: 35kg
Invoice No.: 20220602-1 dated: 29.07.2022.
chromatograms,
etc.
No.
1. 2.2 It is not clearly mentioned that what The firm vide letter No. RA-QR/324/0623
will be the colour of HDPE plastic dated 03.07.2023 has submitted that the
bottle, how will it be marked for colour of HDPE bottle is white with marked
addition of water for reconstitution. line on the bottle for addition of water for
This needs to be clearly mentioned. reconstitution.
clearance and import license is
required.
required.
14th day.
Decision: Registration Board approved the application of Getaclor 250mg/5ml Powder for Suspension.
Karachi.
Karachi.
☐ Importer
☐ Export sale
19.01.2023
The proposed proprietary name / brand name Getaclor 50mg/ml Drops
Cefaclor ……………………………….50mg
ATC Code: J01DC04
The status in reference regulatory authorities PMS-CEFACLOR 250 - PWS 50MG/ML
Health Canada: Cancelled Post Market
For generic drugs (me-too status) Ceclor Drops 50mg/ml
Reg No. 098675
China.
Batches: DBC-1010-202108001, DBC-1010-
202108002, DBC-1010-202108003
product.
Pharmaceutical equivalence and comparative Test product: GETACLOR Drops 50mg/ml Batch
dissolution profile No. C003DS01 Mfg 09.2022 Exp 09.2024.
Reference Product: Ceclor Drops 50mg/ml Batch
No. A8192, Mfg date: Oct-2022 Exp. Date: Mar 2024.
comparator Ceclor Drops 50mg/ml Batch No. A8192,
Mfg date: Oct-2022 Exp. Date: Mar 2024.
of M/s AGP Limited by performing quality tests
substances).
other.
API Lot No. DBC-1010-202111017
Description of Pack
Pink granular powder filled in HDPE plastic bottles.
Mfg. Date: 27.11.2022
Exp. Date: 26.11.20240
Quantity: 35kg
Invoice No.: 20220602-1 dated: 29.07.2022.
chromatograms,
etc.
No.
1. 1.5.9 The evidence of RRA (Health The firm vide letter No. RA-QR/333/0723
Canada) is cancelled (post market). dated 07.07.2023 has submitted following
Proper RRA reference is required. response;
“This is to inform you that Cefaclor
50mg/ml (presentation of 250mg/5ml) is a
MHRA approved drug product with the
brand name ‘KEFTID’ by M/s Strides
Pharma UK Ltd., UK. Please refer to
Annexure 1 for evidence of RRA.”
2. 2.2 It is not clearly mentioned that what The firm has submitted that the colour of
will be the colour of HDPE plastic HDPE bottle is white with marked line on
bottle, how will it be marked for the bottle for addition of water for
addition of water for reconstitution. reconstitution.
This needs to be clearly mentioned.
required.
14th day.
Decision: Registration Board approved the application of Getaclor 50mg/ml Oral Drops.
Karachi.
Karachi.
☐ Importer
☐ Export sale
19.01.2023
The proposed proprietary name / brand name Getaclor Capsule 250mg
Strength / concentration of drug of Active Each capsule contains;
Cefaclor………………………….250mg
Pharmaceutical form of applied drug Hard gelatin capsule, containing white to off-white
coloured crystalline powder.
Packed in Alu-PVC blister.
ATC Code: J01DC04
The status in reference regulatory authorities CEFACLOR CAPSULES 250MG, KEFTID
CAPSULES 250MG
MHRA Approved.
For generic drugs (me-too status) Ceclor Capsules 250mg
Reg No. 098681
Evidence of section approval. Capsule (Cephalosporin) issued vide letter No. F.2-
9/2014-Lic (Vol-I) dated 27.02.2023.
China.
Batches: DBC-1010-202108001, DBC-1010-
202108002, DBC-1010-202108003
product.
Pharmaceutical equivalence and comparative Test product: Cefaclor Capsule 250mg Batch No.
dissolution profile C004DS01 Mfg 26.09.2022 Exp 26.09.2024.
Reference Product: Ceclor Capsules 250mg Batch
No. A7387, Mfg date: May-2022 Exp. Date:
April.2024.
Comparative Dissolution profile: Comparable at
all pH
pH 1.2 HCl solution: 89.62% released in 15mins
F2 NA
pH 4.5 Acetate buffer: 93.56% release in 15mins,
F2 NA
pH 6.8 Phosphate buffer:90.38% released in 15mins
F2 NA
comparator Ceclor Capsules 250mg Batch No. A7387,
Mfg date: May-2022 Exp. Date: April.2024.
of dosage unit, water content, disintegration,
dissolution and related substances)
other.
API Lot No. DBC-1010-202111017
Description of Pack Hard gelatin capsule, containing white to off-white crystalline powder. In
(Container closure system) Alu-PVC blister.
Batch Size 5000 capsules 5000 capsules -
Manufacturing Date 26.09.2022 26.09.2022 -
Mfg. Date: 27.11.2022
Exp. Date: 26.11.20240
Quantity: 35kg
Invoice No.: 20220602-1 dated: 29.07.2022.
chromatograms,
etc.
No.
1. - Copy of AD attested invoice of API The firm has submitted required documents
clearance is required. vide letter No. RA-QR/323/0723 dated
03.07.2023.
2. 3.2.P.5.3 Protocol and report for Dissolution Required report is submitted.
method validation/verification is
required.
required.
Decision: Registration Board approved the application of Getaclor 250mg Capsule.
Karachi.
Karachi.
☐ Importer
☐ Export sale
19.01.2023
The proposed proprietary name / brand name Getaclor Capsule 500mg
Strength / concentration of drug of Active Each capsule contains;
Cefaclor………………………….500mg
Pharmaceutical form of applied drug Hard gelatin capsule, containing white to off-white
coloured crystalline powder.
Packed in Alu-PVC blister.
ATC Code: J01DC04
The status in reference regulatory authorities CEFACLOR 500MG CAPSULES, DISTACLOR
500MG CAPSULES
MHRA Approved.
For generic drugs (me-too status) Ceclor Capsules 500mg
Reg No. 098682
Evidence of section approval. Capsule (Cephalosporin) issued vide letter No. F.2-
9/2014-Lic (Vol-I) dated 27.02.2023.
China.
Batches: DBC-1010-202108001, DBC-1010-
202108002, DBC-1010-202108003
product.
Pharmaceutical equivalence and comparative Test product: Cefaclor Capsule 500mg Batch No.
dissolution profile C005DS01 Mfg 09.2022 Exp 09.2024.
Reference Product: Ceclor Capsules 500mg Batch
No. A7388, Mfg date: May-2022 Exp. Date:
April.2024.
Comparative Dissolution profile: Comparable at
all pH
pH 1.2 HCl solution: 89.66% released in 15mins
F2 NA
pH 4.5 Acetate buffer: 89.65% release in 15mins,
F2 NA
pH 6.8 Phosphate buffer:89.90% released in 15mins
F2 NA
comparator Ceclor Capsules 500mg Batch No. A7388,
Mfg date: May-2022 Exp. Date: April.2024.
of dosage unit, water content, disintegration,
dissolution and related substances)
other.
API Lot No. DBC-1010-202111017
Description of Pack Hard gelatin capsule, containing white to off-white crystalline powder. In
(Container closure system) Alu-PVC blister. Packed in secondary carton along with package insert.
Batch Size 5000 capsules 5000 capsules -
Mfg. Date: 27.11.2022
Exp. Date: 26.11.20240
Quantity: 35kg
Invoice No.: 20220602-1 dated: 29.07.2022.
chromatograms,
etc.
No.
1. - Copy of AD attested invoice of API The firm has submitted required documents
03.07.2023.
2. 3.2.P.5.3 Protocol and report for Dissolution Required report is submitted.
method validation/verification is
required.
required.
Decision: Registration Board approved the application of Getaclor 500mg Capsule.
Karachi.
Karachi.
☐ Importer
☐ Export sale
01.02.2023
The proposed proprietary name / brand name Getofin 2g IV Injection.
Pharmaceutical ingredient (API) per unit Ceftriaxone sodium USP equivalent to
Ceftriaxone………..2g
Pharmaceutical form of applied drug White to yellowish-orange crystalline powder, filled

in a clear glass USP type II vial.
Pharmacotherapeutic Group of (API) Third generation cephalosporin
ATC Code: J01DD04
The status in reference regulatory authorities CEFTRIAXONE 2 G POWDER FOR SOLUTION
FOR INJECTION OR INFUSION - PL 34985/0008
MHRA Approved.
For generic drugs (me-too status) Cefxone Injection 2g
Reg No. 055911
M/s Bosch Pharmaceuticals (Pvt.) Ltd.
27.02.2023.
Name and address of API manufacturer. M/s Zhuhai United Laboratories Co. Ltd. No. 2428,
Anji Road, Sanzao Town Jinwan district, Zhuhai,
Guangdong, China.
Copy of GMP certificate No. GD20180909 dated
06.12.2018, issued by CFDA, valid till 05.12.2013 is
submitted.
Batches: 3051408011, 3051408012, 3051408013
product.
Pharmaceutical equivalence and comparative Test product: Getofin Injection 2g Batch No.
Reference Product: Oxidil I.V Injection 2g Batch No.
010H, Mfg date: Aug-2022 Exp. Date: july.2024.
of M/s Healthtek (Pvt.) Ltd (Images of Oxidil 2g IV
Injection are provided)
comparator Oxidil I.V Injection 2g Batch No. 010H,
Mfg date: Aug-2022 Exp. Date: july.2024 of M/s
Healthtek (Pvt.) Ltd by performing quality tests
of dosage unit, water content, and related substances)
other.
Manufacturer of API M/s Zhuhai United Laboratories Co. Ltd. No. 2428, Anji Road, Sanzao Town
Jinwan district, Zhuhai, Guangdong, China.
API Lot No. 3052206016
Description of Pack White to yellowish-orange crystalline powder, filled in a clear glass
(Container closure system) USP type II vial.
Batch Size 2000 Vials 2000 Vials -
2. Approval of API/ DML/GMP certificate of M/s Zhuhai United Laboratories Co. Ltd. No. 2428,
API manufacturer issued by concerned Anji Road, Sanzao Town Jinwan district, Zhuhai,
regulatory authority of country of origin. Guangdong, China.
Copy of GMP certificate No. GD20180909 dated
06.12.2018, issued by CFDA, valid till 05.12.2013 is
submitted.
3. Documents for the procurement of API with Drug Substance: Ceftriaxone Sodium Sterile USP
approval from DRAP (in case of import). Batch No.: 3052206016
Mfg. Date: 08.06.2022
Exp. Date: 05.2025
Quantity: 10Kg
Invoice No.: CEF220712AZ dated: 12.07.2022
chromatograms,
etc.
No.
1. - Copy of AD attested invoice of API Firm has submitted required documents
03.07.2023.
2. - Copy of GMP certificate of API Firm has submitted valid GMP certificate of
manufacturer submitted was valid till drug substance manufacturer vide letter No.
31.10.2018. Latest GMP status f API RA-QR/315/0723 dated 03.07.2023.
3. 3.2.P.2 In pharmaceutical equivalence study, Vide letter No. RA-QR/315/0723 dated
reference product mentioned is 03.07.2023, the firm has stated that
Rocephin Injection 2g whereas pharmaceutical equivalence study was
snapshots attached are of Oxidil 2g IV performed against Oxidil IV Injection 2g
injection. Clarification is required and have resubmitted documents with
along with snapshots of correct corrected name of comparator product and
reference product. 2g injection is currently not available in
local market.
of only 3 months is submitted. data for 6 months vide letter No. RARA-
Stability studies data of 6 months is SD/270 /0623 dated
required. 21.06.2023
Decision: Registration Board approved the application of Getofin 2g IV Injection.
Karachi.
Karachi.
☐ Importer
☐ Export sale
17.01.2023
The proposed proprietary name / brand name Cefastola 250mg Powder for Injection.
Pharmaceutical ingredient (API) per unit Cefotaxime sodium equivalent to
Cefotaxime………..250mg
Pharmaceutical form of applied drug Off-white to pale yellow crystalline powder, filled in
a clear glass USP type II vial.
Supplied with 2ml Ampoule of diluent (Sterile water
for injection)
ATC Code: J01DD01
The status in reference regulatory authorities CEFOTAXIMA NORMON 250 mg POLVO Y
DISOLVENTE PARA SOLUCION INYECTABLE
IV EFG
CIMA Spain Approved.
For generic drugs (me-too status) Claforan 250mg
Reg No. 006056
M/s Sanofi-Aventis Pakistan Ltd.
27.02.2023.
Name and address of API manufacturer. M/s Sinopharm Weiqida Pharmaceutical Co. Ltd.,
Economic & Technological Development Zone, Firt
Medical Zone, Datong, Shanxi, China
Copy of GMP certificate No. SX20180229 dated
06.06.2018, issued by Shanxi Province FDA, valid till
Batches: S012012001, S012012002, S012012003,
S012012004, S012012005, S012012006
product.
Pharmaceutical equivalence and comparative Test product: Cefotaxime Injection 250mg Batch
Reference Product: Claforan Injection 250mg Batch
No. AA043, Mfg date: June-2022 Exp. Date:
May.2024 of M/s Sanofi-Aventis Pakistan Limited
(Images are provided)
comparator Claforan Injection 250mg Batch No.
AA043, Mfg date: June-2022 Exp. Date: May.2024 of
M/s Sanofi-Aventis Pakistan Limited by performing
Uniformity of dosage unit, water content, and related
substances)
other.
Manufacturer of API M/s Sinopharm Weiqida Pharmaceutical Co. Ltd., Economic &
Technological Development Zone, Firt Medical Zone, Datong, Shanxi,
China
API Lot No. S012204021
Description of Pack Off white to pale yellow crystalline powder, filled in clear glass USP type II
(Container closure system) vial along with 2ml sterile water for injection.
2. Approval of API/ DML/GMP certificate of M/s Sinopharm Weiqida Pharmaceutical Co. Ltd.,
API manufacturer issued by concerned Economic & Technological Development Zone, Firt
regulatory authority of country of origin. Medical Zone, Datong, Shanxi, China
3. Documents for the procurement of API with Drug Substance: Cefotaxime Sodium Sterile USP40
approval from DRAP (in case of import). Batch No.: S012204021
Mfg. Date: 24.04.2022
Exp. Date: 23.04.2024
Quantity: 10Kg
Invoice No.: 20220602-1 dated: 29.07.2022
chromatograms,
etc.
No.
1. 1.5.9 RRA could not be verified for strength The firm vide letter No. RA-QR/321/0623
of 250mg dated 03.07.2023 has submitted that product
is approved in CIMA Spain.
The reference is verifiable.
2. - Copy of AD attested invoice of API Documents are submitted.
required.
Decision: Registration Board approved the application of Cefastola 250mg Powder for Injection.
Karachi.
Karachi.
☐ Importer
☐ Export sale
17.01.2023
The proposed proprietary name / brand name Cefastola 500mg Powder for Injection.
Pharmaceutical ingredient (API) per unit Cefotaxime sodium USP equivalent to
Cefotaxime………..500mg
for injection)
ATC Code: J01DD01
The status in reference regulatory authorities Cefotaxime 500mg and 1000mg Powder for Solution
for Injection or Infusion - PL 25975/0043-4;
UK/H/1401/001-2/DC
MHRA Approved.
For generic drugs (me-too status) Claforan 500mg
Reg No. 020483
27.02.2023.
Batches: S012012001, S012012002, S012012003,
S012012004, S012012005, S012012006
product.
Pharmaceutical equivalence and comparative Test product: Cefotaxime Injection 500mg Batch
Reference Product: Claforan Injection 500mg Batch
No. AA045, Mfg date: July-2022 Exp. Date:
June.2024 of M/s Sanofi-Aventis Pakistan Limited
(Images are provided)
comparator Claforan Injection 500mg Batch No.
AA045, Mfg date: July-2022 Exp. Date: June.2024 of
M/s Sanofi-Aventis Pakistan Limited by performing
substances)
other.
China
Description of Pack Off-white to pale yellow crystalline powder, filled in a clear glass USP type
(Container closure system) II vial along with 2ml Sterile water for injection.
Mfg. Date: 24.04.2022
Exp. Date: 23.04.2024
Quantity: 10Kg
Invoice No.: 20220602-1 dated: 29.07.2022
chromatograms,
etc.
No.
required.
Decision: Registration Board approved the application of Cefastola 500mg Powder for Injection.
Karachi.
Karachi.
☐ Importer
☐ Export sale
17.01.2023
The proposed proprietary name / brand name Cefastola 1g Powder for Injection.
Pharmaceutical ingredient (API) per unit Cefotaxime sodium USP equivalent to
Cefotaxime………..1g
for injection)
ATC Code: J01DD01
The status in reference regulatory authorities Cefotaxime 500mg and 1000mg Powder for Solution
for Injection or Infusion - PL 25975/0043-4;
UK/H/1401/001-2/DC
MHRA Approved.
For generic drugs (me-too status) Claforan 1g
Reg No. 006058
27.02.2023.
Batches: S012012001, S012012002, S012012003,
S012012004, S012012005, S012012006
product.
Pharmaceutical equivalence and comparative Test product: Cefotaxime Injection 1g Batch No.
Reference Product: Claforan Injection 1g Batch No.
AA017, Mfg date: May-2022 Exp. Date: April.2024 of
M/s Sanofi-Aventis Pakistan Limited (Images are
provided)
comparator Claforan Injection 1g Batch No. AA017,
Mfg date: May-2022 Exp. Date: April.2024 of M/s
Sanofi-Aventis Pakistan Limited by performing
substances)
other.
China
Description of Pack Off-white to pale yellow crystalline powder, filled in a clear glass USP type
(Container closure system) II vial along with 2ml Sterile water for injection.
Mfg. Date: 24.04.2022
Exp. Date: 23.04.2024
Quantity: 10Kg
Invoice No.: 20220602-1 dated: 29.07.2022
chromatograms,
etc.
No.
1. - Copy of AD attested invoice of API Submitted
required.
Decision: Registration Board approved the application of Cefastola 1g Powder for Injection.
The Central Licensing Board in its 277th meeting approved following new section of M/s Ferozsons Laboratories
Ltd (DML No. 000038);
i. Cream/ointment/Gel Section (Steroid)
2. The above new section were granted vide letter No. F.3-14/2004-Lic (Vol-I) dated 26.10.2020.
447. Name, address of Applicant / Marketing M/s Ferozsons Laboratories Ltd, Amangarh,
Authorization Holder Nowshera, Khyber Pakhtunkhwa.
Name, address of Manufacturing site. M/s Ferozsons Laboratories Ltd, Amangarh,
Nowshera, Khyber Pakhtunkhwa.
DML No. 000038
☐ Importer
GMP status of the firm GMP certificate dated 25.08.2021 valid till
No. F.3-14/2004-Lic (Vol-I) dated 26.10.2020.
specifying Cream/Ointment/gel Section (Steroid)

☐ Export sale
Dy. No. and date of submission Dy. No 5809 dated 01.03.2023
Details of fee submitted PKR 75,000/- Slip No. 015638058904 Dated
15.02.2022
The proposed proprietary name / brand name CRISA 2% TOPICAL OINTMENT
Strength / concentration of drug of Active Each gram contains;
Pharmaceutical ingredient (API) per unit Crisaborole…………20mg
Pharmacotherapeutic Group of (API) Agents for dermatitis, excluding corticosteroids
ATC Code: D11AH06
Pharmaceutical form of applied drug Topical ointment
White coloured ointment filled in Aluminium tube.
Reference to Finished product specifications Innovator’s Specification.
Proposed Pack size 5g, 10g, 15g, 30g, 50g

The status in reference regulatory authorities Eucrisa ointment
FDA Approved.
For generic drugs (me-too status) Not available.
Name and address of API manufacturer. M/s Honour Lab Limited (Unit III)
Plot No.4, Hetero Infrastructure Ltd., SEZ, N.
Narasapuram Village, Nakkapalli Mandal,
Visakhapatnam District - 531 081, Andhra
Pradesh, INDIA
properties, solubility’s, physical form,
drug substance (CS20120002) and drug product.
drug substance.
30°C ± 2°C / 65% ± 5% RH for 48 months.
Batches: 18070002, 18070003, 18070004.
specifications, analytical procedures, verification
of analytical procedures, batch analysis,
Dissolution Profile their product against product Eucrisa Ointment 2%
Batch No. PMEK, mfg date: -, Exp date: 09.2022
manufactured by M/s Pfizer labs (spain).
Tests like physical characteristics and Assay were
performed and results of both products are
comparable.
Firm has not performed tests like viscosity, content
uniformity
Dissolution: Acid stage F2: 69.04, Acetate buffer
F2: 68.50, Phosphate buffer F2: 70.60
Firm has used Tefose 63 premix (Polyoxyl 6
Stearate Type I, Ethylene Glycol Stearates and
Polyoxyl 32 Stearate Type I) instead of mixture of
mono and di glycerides (used by innovator), rest of
the formulation is same.
Pictorial evidence of pack of Reference product is
provided but batch No. and expiry are not visible.
product.
Manufacturer of API M/s Honour Lab Limited (Unit III)
Plot No.4, Hetero Infrastructure Ltd., SEZ, N. Narasapuram Village,
Nakkapalli Mandal, Visakhapatnam District - 531 081, Andhra
Pradesh, INDIA
API Lot No. CS20120002
Description of Pack
White coloured ointment filled in Aluminium tubes.
Frequency Accelerated: 0, 3, 6(Months)
Real Time: 0, 3, 6(Months)
Batch No. 057NS04 057NS05 057NS06
Batch Size 60 tubes 60 tubes 60 tubes
No. of Batches 03
1. Reference of previous approval of applications Submitted
2. Approval of API/ DML/GMP certificate of API Copy of manufacturing license vide No. HMF07-
manufacturer issued by concerned regulatory 14051/289/2020-Tech-DCA valid till 09.04.2023
authority of country of origin. issued by Drugs Control Administration Andhra
Pradesh India is submitted.
GMP certificate is not submitted
3. Documents for the procurement of API with Crisaborole
approval from DRAP (in case of import). Quantity: 0.280 kg
Batch No. CS20120002
Mfg. Date: 12.2020
Exp date: 11.2024
Clearance date: 12.11.2021
Invoice No. G2203SE-384
Invoice date: 18.10.2021
5. Compliance Record of HPLC software 21CFR & Firm has submitted certificate of 21 CFR
audit trail reports on product testing compliance for the HPLC system along with audit
trail report for product testing.
No.
1. Product is non-steroidal, the section The firm vide letter No PDFLL-
approval is for steroidal topical 1417317032 dated 13.07.2023 has
products, justification is required. submitted section approval letter of topical
- general section. The section was granted
vide letter No. 03-14/2004-Lic(pt) dated
09.04.2020. It was approved in 274th
meeting.
2. Copy of GMP certificate of drug Submitted.
substance manufacturer is required. Cert No. HMF 07-14051/1220/2022-
ADMN-DCA, issued on 15.12.2022.
-
Valid till15.12.2025
Issued by Drugs Control Administration
Andhra Pradesh India.
3. Clear image of reference product Submitted;
pack is required in which batch No Eucrisa Ointment 2%
and expiry shall be readable. Made in Spain
3.2.P.8
Distributed by Pfizer
Lot No. PMEK
EXP: Sep 2022.
Decision: Registration Board approved the application of CRISA 2% Topical Ointment.
The Central Licensing Board in its 278th meeting approved following new sections of M/s Wezen
Pharmaceuticals (DML No. 000880);
i. Tablet (General)
ii. Capsule (General)
iii. Sachet (General)
iv. Ointment/ Cream/ Gel (General)
2. The above new sections were granted vide letter No. F.1-30/2014-Lic dated 30.12.2020.
448. Name, address of Applicant / Marketing M/s Wezen Pharmaceuticals, Plot No. 23 & 24,
Authorization Holder S-1, RCCI Industrial Estate, Rawat.
Name, address of Manufacturing site. M/s Wezen Pharmaceuticals, Plot No. 23 & 24, S-
1, RCCI Industrial Estate, Rawat.
DML No. 000882
☐ Importer
GMP status of the firm The firm was granted Tablet (General) section on
30.12.2020.
dated 30.12.2020 specifying Tablet (general)
Section.

☐ Export sale
01.01.2023
The proposed proprietary name / brand name ROSTA 5mg Tablet
Strength / concentration of drug of Active Each film coated tablet contains;
Pharmaceutical ingredient (API) per unit Rosuvastatin calcium equivalent to
Rosuvastatin………5mg
Pharmacotherapeutic Group of (API) HMG CoA reductase inhibitors
ATC Code: C10AA07
Pharmaceutical form of applied drug White, round, biconvex film coated Tablets.
Reference to Finished product specifications USP Specifications.
The status in reference regulatory authorities Rosuvastatin 5 mg, 10 mg, 20 mg and 40 mg Film-
Coated Tablets (rosuvastatin calcium) - PL
08553/0590-593
MHRA Approved.
For generic drugs (me-too status) Rovista Tablet 5mg Reg No. 044043
M/s Getz Pharma (Pvt.) Ltd. Karachi.
Name and address of API manufacturer. M/s Morepen Laboratories Limited, Village
Malkumajra (Morepen Village), Baddi Nalagarh
Road, Badi Solan, Himachal Pradesh, India.
drug substance (RT12-9058) and drug product.
drug substance.
30°C ± 2°C / 65% ± 5% RH for 36 months.
Batches: RT-12-KL-0001, RT-12-KL-0002, RT-
12-KL-0003.
Dissolution Profile their product against product Rovista 5mg Tablet
Batch No. F05008, mfg date: 04.2022, Exp date:
04.2025 manufactured by M/s Getz Pharma
Karachi.
Tests like Appearance, DT, Weight variation,
Identification, Dissolution and Assay were
comparable.
Dissolution: Acid stage F2: 96, Acetate buffer F2:
98, Phosphate buffer F2: 97
not attached
product.
Manufacturer of API M/s Morepen Laboratories Limited,
Village Malkumajra (Morepen Village), Baddi Nalagarh Road, Badi Solan,
Himachal Pradesh, India.
API Lot No. RT12-9058
Description of Pack Alu-Alu Blister of 1x10’s further packed in bleach card unit carton along
(Container closure system) with Leaflet.
No. of Batches 03
1. Reference of previous approval of applications Not Submitted
with stability study data of the firm (if any) New DML
DML was issued in Feb 2023
manufacturer issued by concerned regulatory 173205) dated 04.02.2019 issued by Health and
authority of country of origin. Family Welfare Department, Himachal Pradesh
Indua. The certificate specifies that the firm
complies with GMP as stipulated under the
provisions of Revised Schdule M of the Drugs *
Cosmetic Rules 1945 in respect of category of Bulk
Drugs. Certificate was valid till 03.02.2021
3. Documents for the procurement of API with Rosuvastatin Calcium IH grade
approval from DRAP (in case of import). Taken loan from WNSFEILD Pharmaceuticals
Hattar.
Quantity: 4kg
Batch No. RT12-9058
Mfg. Date: Sept 2019
Clearance date: August 2023
Invoice No. MBE20192000256
5. Compliance Record of HPLC software 21CFR & Not submitted.
No.
1. Pictorial evidence of pack of product used in CDP is required. The batch No. of the
3.2.P.2.2.1
product used shall be visible and readable.
2. Pharmaceutical equivalence is established against brand leader. Clarification is
3.2.P.2.2.1
required why is it not established against innovator product.
3. In analytical procedure, photocopy of monograph is attached. Verified testing
method (Standard Analytical Procedure) is required wherein it should be
3.2.P.5.2
mentioned that how many tablets are being taken for preparation of sample solution
and what is its strength.
4. Detailed Standard Analytical Procedure for performing dissolution test along with
3.2.P.5.2
its verification report is required.
5. Record of digital data logger for temperature and humidity monitoring of stability
chambers is required
6. Compliance Record of HPLC software 21CFR & audit trail reports on product
testing are required.
7. Only a list of previous approval of applications with stability study data in tablet
section is required.
DML No. 000882
☐ Importer
30.12.2020.
Section.

☐ Export sale
31.01.2023
ATC Code: C10AA07
08553/0590-593
MHRA Approved.
drug substance.
30°C ± 2°C / 65% ± 5% RH for 36 months.
12-KL-0003.
Karachi.
comparable.
97, Phosphate buffer F2: 95.
not attached
product.
No. of Batches 03
Hattar.
Quantity: 4kg
Batch No. RT12-9058
No.
3.2.P.2.2.1
3.2.P.2.2.1
3.2.P.5.2
mentioned that how many tablets are being taken for preparation of sample
solution, how it is prepared for different and what is its strength.
3.2.P.5.2
shortcomings.
DML No. 000882
☐ Importer
30.12.2020.
Section.

☐ Export sale
31.01.2023
ATC Code: C10AA07
08553/0590-593
MHRA Approved.
drug substance.
30°C ± 2°C / 65% ± 5% RH for 36 months.
12-KL-0003.
Karachi.
comparable.
96, Phosphate buffer F2: 93.
not attached
product.
No. of Batches 03
Hattar.
Quantity: 4kg
Batch No. RT12-9058
No.
3.2.P.2.2.1
3.2.P.2.2.1
3.2.P.5.2
mentioned that how many tablets are being taken for preparation of sample
solution, how it is prepared for different and what is its strength.
3.2.P.5.2
shortcomings.
Case No. 02 Priority registration of Isoflurane Inhalational Solution

DRAP in its 143rd meeting of Authority held on 05th August, 2022, keeping in view of essentiality,
criticality of isoflurane and pursuance from Government of Punjab to ensure its availability in
Pakistan decided that registration application of Isoflurane shall be considered “out of queue” by
the Registration Board. Available applications of Isoflurane 100ml & 250ml liquid for inhalation,
are presented below:
451. Name, address of Applicant / Importer M/s MAFHH Enterprises, Shop No. A-71, Rabia Palace
Block-10A, Gulshan-e-Iqbal, Karachi.
Details of Drug Sale License of importer License No: 0302
Address: MAFHH Enterprises, Shop No. A-71, Rabia
Place Block-10A, Gulshan-e-Iqbal, Karachi.
(a) Shop No. A-71, Rabia Place Block-10A, Gulshan-e-
Iqbal, Karachi
(b) A-42 Bukhari Town, Block 10-A, Gulshan-e-Iqbal,
Karachi.
Validity: 08.01.2028
Status: License to sell Drugs by way of Wholesale.
Name and address of marketing M/s Pharmastars Pharmaceuticals, 24 Ahmed Tayseer
authorization holder (abroad) St, Ard El Golf, Caro, Egypt.
Name, address of manufacturer(s) M/s Sunny Pharmaceutical
Address: Badr City- 1-00, Acre Zone- Piece No. 37 &
38 Cairo- Egypt.
Name of exporting country Arab Republic of Egypt

Detail of certificates attached (CoPP, Free CoPP:
sale certificate, GMP certificate) Firm has submitted legalized CoPP certificate (No.
01017/2023/H) dated 06.04.2023 issued by the
Egyptian Drug Authority.
Name and dosage form on the CoPP certificate
mentioned is “Isoflurane-Pharmastars Pharmaceuticals
Volatile liquid for inhalation” and name of the product
license holder is Pharmastars Pharmaceuticals, 24
Ahmed Tayseer St, Ard El Golf Cairo, Egypt.
The certificate also confirms that the applied
formulation is actually on the market in the exporting
country.
The name of importing country on CoPP is mentioned
as Pakistan. The validity of COPP is not mentioned.
GMP:
Applicant has submitted Copy of GMP certificate No.
P-850/2022 dated 11.10.2022 issued by Egyptian Drug
Authority in the name of M/s Sunny Pharmaceutical,
Parts No. (37, 38), Industrial Zone (100 Fadan Shark El
Roubaky)- Badr City-Cairo having its manufacturing
site at same address. The certificate confirms that
manufacturing facility complies with the principles and
guidelines for the pharmaceutical dosage form
categories and/or activities listed in the part 2. ( in part
2 Production line for liquid anesthetics for inhalation is
mentioned under heading of non-sterile products.) The
certificate is valid till 11.10.2023
Details of letter of authorization / sole Firm has submitted Copy of Authorization letter. The
agency agreement letter specifies that product license holder i.e. M/s
Pharmastars Pharmaceuticals, 24 Ahmed Tayseer
Street, Ard El Golf, Helipolis, Cairo, Egypt authorizes
M/s MAFHH Enterprises, Suit No. A-71, Rabia Palace,
Gulshan-e-Iqbal Block 10/A, Main Rashid minhas
Road, Karachi to register Pharmastars product
“Isoflurane-Volatile Liquid for inhalation”, trade name
“MAFRANE” at the Drug Regulatory Authority of
Pakistan (DRAP and import it exclusively to the market
of Pakistan
The authorization is valid till 31.12.2028.
☒ Importer
☐ Export sale
only
Dy. No. and date of submission Dy. No. 14077 dated 06-06-2023.
Details of fee submitted PKR 150,000/- vide slip No. 9621641780 Dated: 17-
05-2023
The proposed proprietary name / brand MAFRANE liquid for inhalation.
name
Strength / concentration of drug of Active Each 100ml bottle contains:
Pharmaceutical ingredient (API) per unit Isoflurane……….100%
Pharmaceutical form of applied drug Volatile liquid for inhalation
Pharmacotherapeutic Group of (API) ANESTHETICS, GENERAL, Halogenated
hydrocarbons.
ATC Code: N01AB06
Reference to Finished product specifications Ph. Eur. Specifications.
Proposed Pack size 100ml/bottle. 1’s
Proposed unit price As per SRO.
The status in reference regulatory authorities AERRANE 100% LIQUID INHALATION VAPOUR
MHRA Approved.
For generic drugs (me-too status) FORANE LIQUID FOR INHALATION
Reg No. 011081
M/s Getz Pharma Karachi.
Name, address of drug substance M/s Shandong New Times Pharmaceutical Co. Ltd.
manufacturer No. 1 North outer ring road, Feixian county, Shandong
Province, China.
Module-III Drug Substance: Firm has submitted partial data. (3.2.S.2.2, 3.2.S.2.3,
3.2.S.2.4, 3.2.S.2.5, 3.2.S.2.6 & 3.2.S.3 not provided)
Firm has not submitted detailed drug substance data
solubility, appearance, manufacturers, description of
manufacturing process & controls and container closure
system.
Firm has submitted specifications (3.2.S.4.1),
analytical procedures (3.2.S.4.2) and its verification
(3.2.S.4.3.1), batch analysis (3.2.S.4.4) and justification
of specification, reference standard (3.2.S.5).
The firm has submitted Certificate of Suitability to the
Monograph of the European Pharmacopoeia (CEP)
issued by EDQM. The certificate of suitability is issued
vide No. R1-CEP 2010-078 - Rev 00 dated 22.04.2016.
The certification is valid as per online record of EDQM
(Substance No. 1673)
Stability Studies of Drug Substance Submitted.
(Conditions & duration of Stability studies) Long term: 25±2℃, RH 60%±5% (Zone II) 36 months
Accelerated: 40±2℃, RH 75%±5% 6 months.
Batches: 090401G, 090402G, 090403G
Degradation studies are also submitted.
description , manufacture, manufacturing process and
process control, process validation protocols, control of
validation of analytical procedures, batch analysis
(20392, 20393, 20394), justification of specifications,
Pharmaceutical Equivalence and Test Product: Isoflurane- Pharmastars
Comparative Dissolution Profile Reference Product: Aerrane
Details of batch numbers and comparison of test

parameters is not provided. The firm has claimed
that their product is equivalent to innovator product
A
As per EMA guideline on the investigation of
bioequivalence “if the product is a gas for
inhalation, bioequivalence studies are not
required.”
product studies for the applied product.
Container closure system of the drug product Carton box containing amber glass bottle (Type III)
containing 100ml liquid, covered with screw cap with
inner liner made of polypropylene and violet
polyethylene plastic collar with insert leaflet.
Stability study data of drug product, shelf life Shelf life 24 months
and storage conditions Storage conditions: store at temperature not exceeding
30℃
Stability Studies conditions:
Long term: 30℃ ± 2℃, RH 65% ± 5% (upto 12
months)
Accelerated: 40℃ ± 2℃, RH 75% ± 5% (upto 6
months)
Batches: 20392, 20393, 20394 (Commercial batches)
Therapeutic indications in USFDA. FORANE (isoflurane, USP) may be used for induction
and maintenance of general
anesthesia. Adequate data have not been developed to
establish its application in obstetrical anesthesia.
Evaluation by PEC:
No.
1. Copies of following documents are  The firm has submitted legalized
submitted, their original legalized copies COPP.
are required;  GMP certificate is not legalized but is
i. COPP. verifiable from official website of
ii. GMP certificate. Egyptian Drug Authority.
iii. Authorization Letter.  p-850-2022.pdf (edaegypt.gov.eg)
 Notarized Authorization letter is
submitted.
2. 3.2.S.7 Stability studies of drug substance done by Submitted.
drug substance manufacturer as per ICH Long term: 25±2℃, RH 60%±5% (Zone II)
guidelines for Zone-IVa along with details Accelerated: 40±2℃, RH 75%±5%
of container closure system are required.
3. 3.2.P.2.2.1 It is mentioned that your product is The MA holder has submitted
pharmaceutically equivalent to innovator Pharmaceutical equivalence studies,
product Aerrane. Test product: Isoflurane-Pharmastars
Batch Numbers, manufacturing date, Pharmaceuticals. Batch No. 220814,
expiry date and comparison of both 220815, 220816.
products is not provided. Reference product: Isoflurane-Genomics
Further pictorial evidence of Aerrane used Batch No. 22655001, manufactured by The
for comparison is required indicating its Arab Company for Gelatin and
batch number, manufacturing date and Pharmaceutical Products – Egypt.
expiry date. Parameters compared: Appearance,
solubility, Identification, Limit tests for
Chloride, impurities, fill volume and assay.
As per comparison, both products are
pharmaceutically equivalent.
4. 3.2.P.5.1 Finished product specifications are claimed The reply of firm is reproduced below;
to be Ph. Eur Specifications but assay “Regarding assay specifications, there is no
specifications are mentioned as USP. actual chemical test for the assay in both EP
Clarification is required. and the USP monographs. The only
chemical test is for the quantification of
impurities. Only the USP monograph states
that assay is calculated by subtracting the
sum of percentages of the impurities from
100% and gives a limit of 99.9%-100%
The finished product specifications adopted
this method of calculation from the USP
monograph.”
The reply of firm is satisfactory.

5. 3.2.P.5.2 In procedure for Identification by IR it is The drug product manufacturer has given
written that sample shall be applied to following reply;
scanning lens of FT-IR apparatus by using “Kindly be informed that identification of
glass pipette indicating acquisition of isoflurane by FT-IR is done using Bruker
spectra in liquid phase, whereas as per Alpha IR instrument in liquid phase due to
European Pharmacopoeia identification lack of an instrument capable of measuring
test spectra is to be acquired in gaseous the sample in gaseous phase.
state. Identification is done using isoflurane
Clarification is required for deviation from EDQM reference standard measured and
the pharmacopoeial procedure. saved in the instrument library, comparing
Further submit the following; spectrum of sample with that of standard is
i. Ph. Eur reference spectrum of done automatically by software”
Isoflurane.
ii. IR Spectra of 3 batches of The drug product manufacturer has deviated
Isoflurane acquired by drug from pharmacopoeial testing method for
product manufacturer. identification of isoflurane due to lack of
iii. Evidence of FT-IR equipment required instrument.
capable of acquiring spectra in
gaseous phase/ FTIR gas analyser
being available with drug product
manufacturer.
6. 3.2.P.8.3 Shelf life claimed is of 24 months, whereas Required data is submitted for batch No.
real time stability data of 3 batches is only 20392, 20393 & 20394
submitted for up to 12 months.
Complete stability studies data for whole of
shelf life of mentioned batches is required.
Decision: Approved as per Policy for inspection of Manufacturer abroad.
Case No. 3:
The Authority in its 165th meeting held on 20th July 2023 approved out of que consideration
of Form-5F applications of Carbamazepine tablet received/applied till 31st December 2023
keeping in view of their repaeated shortage/ non-availability reports in the market and to
ensure timely access of these drugs to public.
452. Name, address of Applicant / Importer M/s We Care, Flat B 6, Block 12D, 2nd Floor, G-8
Markaz, Islamabad.
Details of Drug Sale License of importer License No: DHO-ISB-930
Address: We-Care Revolution in Health Care, Flat No.
B-6, 2nd Floor, Block D-12, Sector G-8 Markaz,
Islamabad.
(b) Nil
Validity: 18.06.2025
Status: Distribution License.
Name and address of marketing M/s. Troikaa Pharmaceuticals Ltd. C-1 Sara Industrial
authorization holder (abroad) Estate, Selaqui, Dehradun, Uttarakhand India.
Name, address of manufacturer(s) M/s. Troikaa Pharmaceuticals Ltd.

C-1 Sara Industrial Estate, Selaqui, Dehradun,
Uttarakhand India.
Name of exporting country India

Detail of certificates attached (CoPP, Free CoPP:
sale certificate, GMP certificate) Firm has submitted notarized copy of CoPP certificate
(No. WHO-GMP-CERT/17P/1/58/2006/5039) dated
24.06.2022 issued by Directorate General of Medical
Health Services, Uttarakhand, India.
Name and dosage form on the CoPP certificate
mentioned is “TROYPOFOL (PROPOFOL
INJECTION BP IV (1% W/V) 20ML VIAL” and name
of the product license holder is Troikaa
Pharmaceuticals Ltd. C-1 Sara Industrial Estate,
Selaqui, Dehradun, Uttarakhand India.
The certificate also confirms that the applied
formulation is actually on the market in the exporting
country.
The name of importing country on CoPP is mentioned
as Pakistan. Validity: 27.05.2024
GMP:
Applicant has submitted Notarized Copy of GMP
certificate No. 17P/1/58/2006 dated 01.06.2021 issued
by Directorate General of Medical Health Services,
Uttarakhand, India in the name of M/s Troikaa
Pharmaceuticals Ltd. C-1 Sara Industrial Estate,
Selaqui, Dehradun, Uttarakhand India having its
manufacturing site at same address.
The certificate confirms that the firm is following Good
Manufacturing practices as per WHO TRS Guidelines.
(SVP Ampoule & Vial Non beta lactam)
The certificate is valid till 27.05.2024
Details of letter of authorization / sole Firm has submitted notarized copy of Authorization
agency agreement letter.
The letter specifies that product license holder i.e. M/s
Troikaa Pharmaceuticals Ltd, office: Commerece house
– 1, Satya marg, bodakdev Ahmedabad Gujrat India
manufacturing site: C-1 Sara Industrial Estate,
Selaqui, Dehradun, Uttarakhand India authorizes M/s
We Care, Flat B 6, Block 12D, 2nd Floor, G-8 Markaz,
Islamabad as exclusive distributor for product
“Troypofol (Propofol Injecton BP I.V (1%W/V)” in
Paksitan
The authorization is valid till revoked by Troikaa
Pharmaceuticals Ltd.
☒ Importer
☐ Export sale
only
Details of fee submitted PKR 150,000/- vide slip No. 3123580695 Dated: 22-
02-2023
The proposed proprietary name / brand Troypofol 10mg/ml(1%W/V) IV injection
name
Strength / concentration of drug of Active Each 20ml Vial Contains
Pharmaceutical ingredient (API) per unit Propofol BP………….200mg
Excipients:
Soybean oil USP
Glycerol BP
Egg Lecithin
Water for injection BP
Pharmaceutical form of applied drug Emulsion for IV injection or Infusion.
Pharmacotherapeutic Group of (API) Other general anesthetics
ATC Code: N01AX10
Reference to Finished product specifications BP Specifications.
The status in reference regulatory authorities PROPOFOL-LIPURO 1% (10 MG/ML)
MHRA Approved.
For generic drugs (me-too status) Propofol Lipuro 1% (10mg/ml) 20ml
Reg No. 033126
M/s B Braun.
Name, address of drug substance M/s BACHEM SA, Succursale de Vionnaz, Route du
manufacturer Simplon 22 1895 Vionnaz, Switzerland.
&
M/s Neuland Laboratories Ltd. Unit-II, Plot No. 92-94,
257-259, IDA, Pashamylaram, Isnapur Village,
Patancheru Mandal, Sangareddy District, Telangana
State, India.
(Manufacturer has mentioned 2 source of API)
Module-III Drug Substance: Firm has submitted detailed drug substance data related
solubility, appearance, manufacturers, description of
manufacturing process and controls, specifications,
substance.
Stability Studies of Drug Substance Stability studies are submitted;
(Conditions & duration of Stability studies) Long term conditions: 5 ± 3℃ & 25℃- 60% RH, for 5
years
Accelerated = 40℃-75% RH for 6 months.
Batches: L-22270-411-003, L-22270-411-004, L-
22270-411-005, L-22270-411-021, L-22270-411-022,
L-22270-411-024, 5001761, 5002651, 5003446,
5004093, 5004824, 5005445, 1000005184,
1000012637, 1000018794, 1000028887.
description , manufacture, manufacturing process and
validation of analytical procedures, batch analysis
(T236788, T236789, T236790) justification of
specifications, reference standard and materials,
Pharmaceutical Equivalence and Test Product: Troypofol (propofol) 10mg/ml
Comparative Dissolution Profile Emulsion for injection. Batch No. T236585, Expiry
date: 02.21.
Reference Product: Disoprivan 1% (2ml Vial)
Batch No. R16009A, Expiry: 06.2019
manufactured by M/s AstraZeneca GmBH
Firm has submitted Pharmaceutical Equivalence for the

applied product against the reference product i.e.
Disoprivan 1% (2ml Vial) Batch No. R16009A,
Expiry: 06.2019 manufactured by M/s
AstraZeneca GmBH by performing following tests;
Appearance/description, pH, Assay, Globule Size,
Lysolecithin content, Free fatty acid content, Propofol J
impurity, and propofol dimer.
product studies for the applied product.
Container closure system of the drug product Primary Packing: 20mL USP type 1 flint glass vial
with bromo butyl rubber closure and blue flip off
aluminium seal.
Secondary packing: 1 vial packed in printed carton
along with package insert.
Stability study data of drug product, shelf life Shelf life 24 months
and storage conditions Storage conditions: Store below 30℃ and do not freeze.
Stability Studies conditions:
Long term: 30℃ ± 2℃, RH 75% ± 5% (up to 24
months)
Accelerated: 40℃ ± 2℃, RH 75% ± 5% (up to 6
months)
Batches: T236585, T236586, T236587 (Commercial
batches manufactured from API of M/s Bachem SA)
Batches: T236560, T236561, T236562 (Commercial
batches manufactured from API of M/s Neuland
Laboratories)
Therapeutic indications in MHRA Diprivan 1% is a short-acting intravenous general
anaesthetic for:
 Induction and maintenance of general
anaesthesia in adults and children >1 month.
 Sedation for diagnostic and surgical
procedures, alone or in combination with local
or regional anaesthesia in adults and children
>1 month.
 Sedation of ventilated patients >16 years of age
in the intensive care unit.
Evaluation by PEC:
No.
1. Legalized copies of following documents
are required;
i. COPP
ii. GMP certificate of drug product
manufacturer.
Decision: Approved as per policy for inspection of manufacturer abroad. Registration letter shall be
issued upon submission of legalized Original CoPP & Notarized copy of letter of authorization.
453. Name, address of Applicant / Marketing M/s Titlis Pharma, 528-A, Sundar Industrial Estate,
Authorization Holder Raiwind Road, Lahore.
Name, address of Manufacturing site. M/s Titlis Pharma, 528-A, Sundar Industrial Estate,
Raiwind Road, Lahore.
DML No. 000799
☐ Importer
GMP status of the firm GMP certificate dated 15.12.2022 valid till 11.12.2024
is submitted.
Evidence of approval of manufacturing Firm has submitted copy of letter of grant of section
facility dated 03.07.2014 specifying Tablet (general) Section.

☐ Export sale
Details of fee submitted PKR 30,000/- Slip No. 30359710551 Dated 07.02.2022
The proposed proprietary name / brand name CARBALIS 200mg TABLET
Strength / concentration of drug of Active Each tablet contains;
Pharmaceutical ingredient (API) per unit Carbamazepine…………200mg
Pharmacotherapeutic Group of (API) Antiepileptic, Carboxamide derivatives,
ATC Code: N03AF01
Pharmaceutical form of applied drug Round biconvex shape, white coloured film coated
tablets,
Alu-PVC blister of 100x10’s.
Packed in cardboard carton.
The status in reference regulatory authorities CARBAMAZEPINE NOUMED 200 MG TABLETS -
PL 44041/0035
MHRA Approved.
For generic drugs (me-too status) Togra 200mg Tablets Reg. No. 085387
M/s Rotex Pharma (Pvt.) Ltd. Islamabad.
Name and address of API manufacturer. M/s Zhejiang Jiuzhou Pharmaceutical Co. Ltd. No. 99
Waisha Road, Jiaojiang District, Taizhou City,
Zhejiang Province, China.
substance (200100A200310) and drug product.
Module-III Drug Substance: Firm has submitted detailed drug substance data related
solubility, physical form, manufacturers, description of
substance.
time stability data is conducted at 30°C ± 2°C / 75% ±
Batches: W160612316, W160613317, W160614318.
analytical procedures, verification of analytical
procedures, batch analysis, justification of
Pharmaceutical Equivalence and Firm has submitted pharmaceutical equivalence of their
Comparative Dissolution Profile product against product Tegral 200mg tablet Batch No.
RK7M, mfg date: 11.2021, Exp date: 11.2023
manufactured by M/s Novartis Pharma (Pakistan)
Limited.
Tests like DT, Weight variation, Identification,
Dissolution and Assay were performed and results of
both products are comparable.
Dissolution: Acid stage F2: 69.04, Acetate buffer F2:
68.50, Phosphate buffer F2: 70.60
Pictorial evidence of pack of Reference product is not
attached
Analytical method validation/verification of Firm has submitted analytical method verification study
product reports for drug substance as well as drug product.
Manufacturer of API M/s Zhejiang Jiuzhou Pharmaceutical Co. Ltd.
No. 99 Waisha Road, Jiaojiang District, Taizhou City, Zhejiang Province,
China.
API Lot No. 200100A200310
Description of Pack Round biconvex shape, white coloured film coated tablets,
(Container closure system) Alu-PVC blister of 100x10’s.
Packed in cardboard carton.
Batch No. 20324 20325 20326
Batch Size 233,333 tablets 233,333 tablets 233,333 tablets
No. of Batches 03
with stability study data of the firm (if any) Submission is optional
manufacturer issued by concerned regulatory ZJ220018) dated 26.01.2022 issued by Zhejiang
authority of country of origin. Medical Products Administration China. The
certificate specifies that the firm complies with the
requirements of the Chinese GMP (=GMP of EU,
WHO/ICH Q7). Certificate was valid till 25.01.2025
3. Documents for the procurement of API with CARBAMAZEPINE
approval from DRAP (in case of import). Quantity: 2125 kg
Batch No. 200100A200309, 200100A200310
Mfg. Date: 03.2020
Clearance date: 20.03.2020
Invoice No. 20SJ03052
API imported for manufacturing of product registered
for export purpose.
5. Compliance Record of HPLC software 21CFR & Firm has submitted certificate of 21 CFR compliance
audit trail reports on product testing for the HPLC system along with audit trail report for
product testing.
No.
1. In description its mentioned that The firm vide letter No. R.A/TP/2023/113
product will be film coated. In Form- dated 12.07.2023 has stated their product
5F, the product is not mentioned as is aqueous film coated.
film coated tablet. In all other They have said that their product is
sections of module 3, product is pharmaceutically equivalent to brand
2.3.P.5
mentioned as film coated. leader Tegral 200mg Tablet.
-Innovator product is not film coated -The firm has not provided any evidence of
whereas the product manufactured RRA approved product that is film coated.
for trials is film coated.
2. Analytical method validation Submitted vide letter No.
3.2.P.5.3 protocol/Report for dissolution is R.A/TP/2023/113 dated 12.07.2023
required.
Decision: The Board deferred the case for submission of product development & stability studies data for
revised formulation as per innovator drug product i.e., uncoated tablet along with full fee of
registration as per SRO 496(I)/2023 dated 17.04.2023.
Case No. 4: Deferred Cases.

454. Name, address of Applicant / Marketing M/S Herbion Pakistan Pvt Ltd Islamabad.
Name, address of Manufacturing site. M/s Herbion Pakistan Pvt Ltd Industrial
Triangle Kahuta road, Islamabad. (DML No.
000795)
☐ Importer
giver)
☐ Export sale
Dy. No. and date of submission Dy. No. 1305-R & I, Dated 14/01/2022
Details of fee submitted PKR 30,000/- vide online deposit slip
No.206764738781 Dated 27/12/2021
The proposed proprietary name / brand name Estresto 50 mg tablet
Pharmaceutical ingredient (API) per unit Sacubitril ----------- 24.3 mg
Valsartan ----------------------25.7 mg
Pharmaceutical form of applied drug Violet color, Oblong shape, plain on both side,
film coated tablet
Pharmacotherapeutic Group of (API) Sacubitril, a neprilysin inhibitor, and
valsartan, an angiotensin II receptor blocker
indicated: to reduce the risk of cardiovascular
death and hospitalization for heart failure in
patients with chronic heart failure (NYHA
Class II-IV) and reduced ejection frac
Reference to Finished product specifications As per Innovator’s specifications
Proposed Pack size 1* 14’s (14’s)
2*14’s (28’s)
The status in reference regulatory authorities Entresto tablets 50 mg
Novartis Pharmaceuticals (FDA Approved)
For generic drugs (me-too status) Savesto 24.3/25.7mg tablet of M/s Getz
Parma, Karachi. Registration No.093110
GMP status of the Finished product manufacturer Most recent GMP inspection report conducted
within last three years required.
Name and address of API manufacturer. Sacubitril & Valsartan:
Address No.15, Donghai 5th Avenue,
Zhejiang Provincial Chemical and Medical
Raw Materials Base Linhai Zone, Taizhou
City, Zhejiang Province, China.
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO QOS-
PD template. Summarized information related
standard, container closure system and
Module III (Drug Substance) Sacubitril sodium:
Official monograph of sacubitril sodium does
not exist so firm has followed in house
specifications. The firm as submitted detail of
controls, tests for impurity SCB-4-Imp-1,
SCB-5-Imp-2, SCB-5-I Sodium (chiral
isomer, SCB-5-II Sodium (chiral isomer SCB-
5-III Sodium (chiral isomer) specifications,
analytical procedures and its validation , batch
reference standard, container closure system
and stability studies of drug substance
Valsartan:
Official monograph of valsartan exists in USP.
structure, general properties, solubilities,
impurity Valsartan Related Compound A: Not
more than (NMT) 1.0% Valsartan Related
Compound B: Not more than (NMT) 0.2%
Valsartan Related Compound C: Not more
than (NMT) 0.1% Any other individual
impurity: Not more than (NMT) 0.1% Total
impurities: Not more than (NMT) 0.3%,
substance.
Stability studies Sacubitril Sodium:
Stability study conditions (Zone IVb).
months 0, 3, 6, 9, 12, 18, 24 months.
for 6 months at 0, 1, 2, 3, 6 months
Batches: (13700-181001, 13700 -181002,
13700-181003)
Valsartan:
Stability study conditions:
months 0, 3, 6, 9, 12, 18, 24, 36 months.
for 6 months.
Batches: (201207301, 201207302,
201207303)
Module-III (Drug Product): The firm has submitted detail of
process and controls, impurities,
specifications, analytical procedure (including
dissolution testing at acidic and buffer
medium) and its verification studies, batch
and stability studies of drug product.
dissolution profile established against Savesto 50mg tablet of
Getz Pharma, Karachi by performing quality
CDP has been performed against the same
brand that is Savesto 50 mg tablet, batch
No. 007FB2 by Getz Pharma 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.
Analytical method validation/verification of product Sacubitril Sodium:
Method validation studies including linearity,
range, accuracy, precision, intermediate
precision, repeatability, robustness,
specificity, LOD and LOQ.
Valsartan:
Verification studies for valsartan including
Linearity, range, accuracy, precision
(repeatability) and specificity along with
chromatograms and raw data sheets submitted.
Manufacturer of API Zhejiang Tianyu Pharmaceutical Co., Ltd. China.
API Lot No. Sacubitril Sodium (222920-210103) & Valsartan (10252-210201)
Description of Pack Alu-Alu blister packed in unit carton
(Container closure system) (1×14’s)
(2×14’s)
Batch No. EST-50-ST-001 EST-50-ST-002 EST-50-ST-003
No. of Batches 03
1. Reference of previous approval of applications with NA.
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. 201904044
manufacturer issued by concerned regulatory authority issued by Zhejiang Medicine Center for
of country of origin. Economic Development valid till 02/06/2022.
Scope of inspection include (Sacubitril Sodium
Valsartan).
3. Documents for the procurement of API with approval Firm has submitted copy of invoice No.
from DRAP (in case of import). TY121266 dated 19-03-2021 for import of
1.6kg Sacubitril Sodium and 1.7kg Valsartan
USP from Zhejiang Tianyu Pharmaceutical
Co., Ltd. Jiangkou Development Zone
Huangyan Taizhou, Zhejiang, China, attested
by AD (I & E), DRAP Islamabad.
4. Data of stability batches will be supported by attested Submitted
respective documents like chromatograms, Raw data
sheets, COA, summary data sheets etc.
5. Compliance Record of HPLC software 21CFR & audit Submitted

trail reports on product testing.
humidity monitoring of stability chambers (real time
and accelerated).
Remarks of Evaluator: (PEC-XVII)

No.
1. 3.2.S.4.4 Peak areas given for replicates 2-5 of Revised calculation sheet submitted vide
standard injections for assay determination letter No. HB/0039/DRAP/PEC/23
of Sacubitril sodium are different than those
mentioned in corresponding chromatograms
(sample information).
2. The assay calculation formula as given in the Corrected formula submitted vide letter
analytical procedure by the drug product No. HB/0039/DRAP/PEC/23
manufacturer is different than that given in
analytical method validation protocol/data of
the drug product manufacturer.
Moreover, the assay calculation formula as
mentioned in the analytical method of the
drug substance manufacturer and that given
in the analytical method of the drug product
manufacture are not the same.
3. 3.2.P.2.2. In the procedure for CDP, the time point for Firm has stated that it was a mistake and
1 sample withdrawal mentioned as 45 minutes, has submitted correct report vide letter
while in dissolution parameters for CDP and No. HB/0039/DRAP/PEC/23
raw data sheets, the time points mentioned as
10, 15, 20, 30, 45 and 60 minutes.
4. 3.2.P.5.2 Wavelength mentioned as 267nm under Firm has stated that it is their in-house
chromatographic conditions, however, as per method and is validated.
reference/innovator’s product dissolution
method/parameters, the detection
wavelength (HPLC/UV) given as 255 nm.
5. The flow rate in analytical method of drug Firm has stated that it is a typographic
product given as 1ml/min however, in error and has been corrected to 0.8ml/min.
method validation protocol for the drug
product the flow rate given as 0.8ml/min.
6. As per various documents such as CoA of The firm has stated that they have
APIs from substance manufacturer and drug developed product ‘Estresto tablet’ with
product manufacturer, import invoice, AD (I
claims as Sacubitril/Valsartan 24mg/26
& E) clearance certificate, product mg, Sacubitril/Valsartan 49mg/51mg
development data, trial batch manufacturing
and Sacubitril/Valsartan 97mg/103 mg.
record and separate stability summary dataThis happened only because of
sheets for Sacubitril sodium and Valsartan by
availability of Raw materials at the time
the drug substance manufacturer reflect that
of development which was the peak era
Sacubitril sodium and Valsartan used as of Covid-19 and there were lot of issues
separate materials, while the innovator in importing raw materials.
product is designed as a combination of Now their R&D team has started
sacubitril and valsartan in a co-crystal, is a
product development using Sacubitril
salt complex comprising LCZ696
valsartan complex, its trial batch is
(Sacubitril/Valsartan anionic moieties), under development please
sodium cations, and water molecules. Please
They will also share the initial data as it
justify how the applied formulation is in line
will be charged on stability
with innovator’s product. Form 6 of Sacubitril valsartan complex
is also provided.
7. Most recent GMP compliance inspection Firm has submitted GMP certificate valid
report conducted within last three years. till 03.07.2024
Decision of 324th RB meeting: Registration Board was apprised that the letter of shortcoming has been initially
issued to the firm, hence Board deferred the case for submission of reply to the above cited shortcomings within six
months.
Remarks of Evaluator: The firm has submitted reply in compliance to decision of 324 th meeting of RB but they
will require more time to submit stability data of batches manufactured from Sacubitril valsartan complex. The firm
has submitted initial data in which product is placed on stability in July 2023.
Decision of 330th meeting: Keeping in view the request of the firm, the Registration Board further extended
time for submission of shortcomings within a period of 6 months of publication of minutes of instant meeting.
455. Name, address of Applicant / Marketing M/S Herbion Pakistan Pvt Ltd Islamabad.
000795)
☐ Importer
giver)
☐ Export sale
No.6954377589 Dated 27/12/2021
Pharmaceutical ingredient (API) per unit Sacubitril ----------- 48.6 mg
Valsartan ----------------------51.4 mg
Pharmaceutical form of applied drug Oval shaped, pale-yellow colored, film coated
tablet, plain on both sides.
2*14’s (28’s)
For generic drugs (me-too status) Savesto 49/51mg tablet of M/s Getz Parma,
Karachi. Registration No.093111
Name and address of API manufacturer. Sacubitril Sodium & Valsartan:
Valsartan:
substance.
months 0, 3, 6, 9, 12, 18, 24 months.
Batches: (13700-181001, 13700 -181002,
13700-181003)
Valsartan:
months 0, 3, 6, 9, 12, 18, 24, 36 months.
for 6 months.
Batches: (201207301, 201207302,
201207303)
dissolution profile established against Uperio 100mg tablet
(Batch No. TAY84) of Novartis Pharma
(Pakistan), Karachi by performing quality
brand 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.
Valsartan:
(2×14’s)
No. of Batches 03
Valsartan).


trail reports on product testing
6. Record of Digital data logger for temperature and
humidity monitoring of stability chambers (real time Submitted
and accelerated)
No.
1. 3.2.S.4.4 Peak areas given for replicates 2-5 of standard Revised calculation sheet submitted
injections for assay determination of vide letter No. HB/0039/DRAP/PEC/23
Sacubitril sodium are different than those
mentioned in corresponding chromatograms
(sample information).
2. The assay calculation formula as given in the Corrected formula submitted vide letter
analytical procedure by the drug product No. HB/0039/DRAP/PEC/23
manufacturer is different than that given in
analytical method validation protocol/data of
the drug product manufacturer.
drug substance manufacturer and that given in
the analytical method of the drug product
manufacture are not the same.
3. 3.2.P.2.2. In the procedure for CDP, the time point for Firm has stated that it was a mistake
1 sample withdrawal mentioned as 45 minutes, and has submitted correct report vide
while in dissolution parameters for CDP and letter No. HB/0039/DRAP/PEC/23
raw data sheets, the time points mentioned as
10, 15, 20, 30, 45 and 60 minutes.
chromatographic conditions, however, as per method and is validated.
reference/innovator’s product dissolution
method/parameters, the detection wavelength
(HPLC/UV) given as 255 nm.
product given as 1ml/min however, in method error and has been corrected to
validation protocol for the drug product the 0.8ml/min.
flow rate given as 0.8ml/min.
APIs from substance manufacturer and drug developed product ‘Estresto tablet’
product manufacturer, import invoice, AD (I with claims as Sacubitril/Valsartan
& E) clearance certificate, product 24mg/26 mg, Sacubitril/Valsartan
development data, trial batch manufacturing 49mg/51mg and Sacubitril/Valsartan
record and separate stability summary data 97mg/103 mg.
sheets for Sacubitril sodium and Valsartan by This happened only because of
the drug substance manufacturer reflect that availability of Raw materials at the
Sacubitril sodium and Valsartan used as time of development which was the
separate materials, while the innovator peak era of Covid-19 and there were
product is designed as a combination of lot of issues in importing raw
sacubitril and valsartan in a co-crystal, is a salt materials.
complex comprising LCZ696
Now their R&D team has started
(Sacubitril/Valsartan anionic moieties),
product development using Sacubitril
sodium cations, and water molecules. Please
valsartan complex, its trial batch is
justify how the applied formulation is in line
under development please
with innovator’s product. They will also share the initial data as
it will be charged on stability
Form 6 of Sacubitril valsartan
complex is also provided.
7. Most recent GMP compliance inspection Firm has submitted GMP certificate
report conducted within last three years. valid till 03.07.2024
months.
Remarks of Evaluator: The firm has submitted reply in compliance to decision of 324th meeting of RB but they
456. Name, address of Applicant / Marketing M/s Herbion Pakistan Pvt Ltd Islamabad.
000795)
Status of the applicant ☒ Manufacturer l
☐ Importer
giver)
☐ Export sale
No.718801025572 Dated 27/12/2021
Pharmaceutical ingredient (API) per unit Sacubitril ----------- 97 mg
Valsartan ----------------------103 mg
Pharmaceutical form of applied drug Oblong shaped, light-pink colored, film coated
tablet, break-line on one side, other side plain,
no irregularity.
2*14’s (28’s)
For generic drugs (me-too status) Savesto 97/103mg tablet of M/s Getz Parma,
Karachi. Registration No.093112
Name and address of API manufacturer. Sacubitril Sodium & Valsartan:
Valsartan:
substance.
months 0, 3, 6, 9, 12, 18, 24 months.
Batches: (13700-181001, 13700 -181002,
13700-181003)
Valsartan:
months 0, 3, 6, 9, 12, 18, 24, 36 months.
for 6 months.
Batches: (201207301, 201207302,
201207303)
dissolution profile established against Uperio 200mg tablet
(Batch No. THU47) of Novartis Pharma
(Pakistan), Karachi by performing quality
brand 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.
Valsartan:
(2×14’s)
No. of Batches 03
Valsartan).

trail reports on product testing
6. Record of Digital data logger for temperature and
humidity monitoring of stability chambers (real time Submitted
and accelerated)
No.
1. 3.2.S.4.4 Peak areas given for replicates 2-5 of Revised calculation sheet submitted vide
standard injections for assay determination letter No. HB/0039/DRAP/PEC/23
of Sacubitril sodium are different than
those mentioned in corresponding
chromatograms (sample information).
2. The assay calculation formula as given in Corrected formula submitted vide letter
the analytical procedure by the drug No. HB/0039/DRAP/PEC/23
product manufacturer is different than that
given in analytical method validation
protocol/data of the drug product
manufacturer.
drug substance manufacturer and that
given in the analytical method of the drug
product manufacture are not the same.
3. The run time for Valsartan USP given as Firm has stated vide letter No.
40 minutes in analytical method by the HB/0039/DRAP/PEC/23 dated
drug substance manufacturer, while the 22.06.2023 that analysis was performed
chromatograms for method verification according to USP; drug substance
data showed run time around 15-20 manufacturer method claims 40 minutes
minutes. Moreover, retention time of but USP does not recommend 40 minutes
valsartan in method verification The standard retention time in verification
chromatograms/data is about 5.5 minutes studies is 5.5 minutes updated analysis is
while the chromatograms for assay attached having same retention time i.e.
determination of valsartan (Batch 5.5 minutes
No.10252-210201) has Retention time of While previous submitted analysis having
13.1 minutes. 13.1 retention time was due to human
error & instrumental error.
Although both reports having same and
satisfactory results.
4. 3.2.P.2.2. In the procedure for CDP, the time point Firm has stated that it’s a typographic
1 for sample withdrawal mentioned as 45 error and has been corrected
minutes, while in dissolution parameters
for CDP and raw data sheets, the time
points mentioned as 10, 15, 20, 30, 45 and
60 minutes.
chromatographic conditions, however, as method and is validated.
per reference/innovator’s product
dissolution method/parameters, the
detection wavelength (HPLC/UV) given as
255 nm.
product given as 1ml/min however, in error and has been corrected to 0.8ml/min.
method validation protocol for the drug
product the flow rate given as 0.8ml/min.
APIs from substance manufacturer and developed product ‘Estresto tablet’ with
drug product manufacturer, import claims as Sacubitril/Valsartan 24mg/26
invoice, AD (I & E) clearance certificate, mg, Sacubitril/Valsartan 49mg/51mg
product development data, trial batch and Sacubitril/Valsartan 97mg/103 mg.
manufacturing record and separate This happened only because of
stability summary data sheets for Sacubitril availability of Raw materials at the time
sodium and Valsartan by the drug of development which was the peak era
substance manufacturer reflect that of Covid-19 and there were lot of issues
Sacubitril sodium and Valsartan used as in importing raw materials.
separate materials, while the innovator Now their R&D team has started
product is designed as a combination of product development using Sacubitril
sacubitril and valsartan in a co-crystal, is a valsartan complex, its trial batch is
salt complex comprising LCZ696 under development please
(Sacubitril/Valsartan anionic moieties), They will also share the initial data as it
sodium cations, and water molecules. will be charged on stability
Please justify how the applied formulation Form 6 of Sacubitril valsartan complex
is in line with innovator’s product. is also provided.
7. Most recent GMP compliance inspection Firm has submitted GMP certificate valid
report conducted within last three years. till 03.07.2024
months.
Remarks of Evaluator: The firm has submitted reply in compliance to decision of 324 th meeting of RB but they
Case No. 5: Form-5 Deferred Cases
457. Name and address of manufacturer/ M/s Hiranis Pharmaceuticals (Pvt.) Limited,
Applicant Located at plot No. E-145 to E-149, North Western
Industrial Zone, Port Qasim, Karachi.
Brand Name + Dosage Form + Brethease 400mcg/6mcg Capsule
Strength
Composition Each capsule contains:
Formoterol Fumarate………….6mcg
Budesonide…………………….400mcg
Diary No. Date of R & I & fee Dy.No. 939, 28-10-2013, 20,000/-, 28-10-2013
Pharmacological Group Corticosteroid + selective beta2–adrenergic agonist
Type of Form Form 5.
Finished product Specification Manufacturer‘s specifications
Pack size & Demanded Price As per PRC
Approval status of product in Reference Not confirmed
Regulatory Authorities
Me-too status Combivair 400mcg + 6mcg capsule of M/s Highnoon
GMP status Last GMP inspection conducted on 07-09-2017, and
the report concludes that the firm was considered to
be operating at satisfactory compliance with GMP
guidelines.
Remarks of the Evaluator
Previous decision(s) Deferred for product specific inspection by Director

DTL Karachi alongwith FID with following
verifications
(M-243):
Confirmation of approval of formulation by the
stringent regulatory agencies.
Confirmation of API in ultramicronized form.
Remarks of the Evaluator The firm has submitted copy of product specific
inspection conducted by Director DTL, Karachi and
Area FID which concludes as below:
―In the light of manufacturing, Quality Control,
Storage facilities and technical persons met, the
panel is of the view to recommend Registration of a)
Aclidum Capsule, b) Brethease 200mcg/6mcg
Capsule, c) Brethease 100mcg/6mcg Capsule, d)
Brethease 400mcg/6mcg Capsule to the firm under
the Drug Act, 1976.”
Decision of 289th meeting of RB Deferred for evidence of approval of applied
formulation in reference regulatory
authorities/agencies adopted by the Registration
Board in 275th meeting.
Remarks of the Evaluator The firm vide letter No. nil dated 13.06.2023 has
submitted a revised formulation along with fee of Rs.
30,000/-. The revised formulation is;
Each Capsule Contains;
Budesonide…………………….400mcg
Formoterol Fumarate………….12mcg
(Innovator’s Specifications)
For reference of RRA approval, firm has provided

information of Symbicort Turbohaler 400/12
Inhalation Powder MHRA approved. The reference
product is a multi-dose dry powder inhaler,
whereas reference product is a capsule to be
loaded in a DPI device. The firm couldn’t provide
proper evidence of RRA approval of applied
formulation.
Decision: Registration Board decided to reject the application since the firm has not submitted
stability study data of 3 batches of the drug product before the lapse of deadline decided by DRAP
Authority i.e. till 31st December 2022.
458. Name and address of manufacturer/ M/s Bio-Mark Pharmaceuticals.
Applicant 527-Sunder Industrial Estate, Lahore.
Brand Name + Dosage Form + DIVAL Suspension 250mg/5ml
Strength
Composition Each 5ml contains:
Sodium valproate eq to valproic acid…250mg
Diary No. Date of R & I & fee Diary No: 6176, 14/06/2017, Rs: 20,000/-
Pharmacological Group Anti-epileptic drug.
Type of Form Form-5
Finished product Specification Innovator’s specifications
Pack size & Demanded Price 60ml, 120ml/ As per SRO.
Approval status of product in Reference DEPAKENE (valproic acid) oral solution by M/s
Regulatory Authorities AbbVie Inc, USFDA approved.
Me-too status Epilax Syrup 250mg/5ml by M/s Vision
Pharmaceuticals (Reg#037571)
GMP status NEW LICENCE.
Remarks of the Evaluator Firm has claimed Innovator‟s specifications but
product monograph is available in USP.
nd
Decision of 272 meeting of Deferred for evidence of approval of formulation in
registration board. suspension dosage form in Reference Regulatory
Authorities.
Remarks of the Evaluator The firm vide letter N. DRA/035/2023 dated nil has
th
Decision of 289 meeting of RB submitted following new formulation;
Remarks of the Evaluator Dival Syrup 250mg/5ml
Each 5ml contains;
Sodium Valproate eq to Valproic Acid…250mg
The firm has not submitted any fee for the changes
and have also not mentioned specifications of the
finished product.
Decision: Approved with Innovator’s specifications as per following label claim:
Dival Syrup 250mg/5ml
Each 5ml contains;
Sodium Valproate eq to Valproic Acid…250mg
 The firm shall submit fee for correction/pre-approval change in product
composition and label as per SRO496(I)/2023 dated 17.04.2023, before issuance of
459. Name and address of manufacturer/ M/s Bio-Mark Pharmaceuticals.
Applicant 527-Sunder Industrial Estate, Lahore.
Brand Name + Dosage Form + MENTINE Oral syrup
Strength
Composition Each 5 ml Contains:
Memantine Hydrochloride………………….10mg
Diary No. Date of R & I & fee Dy. No.6181 dated 14-06-2017; Rs.20,000/- dated
13-06-
2017. Duplicate Dossier Dy. No 10014 dated 20-
04-2022
Pharmacological Group Glutamate NDMA receptor Antagonist
Type of Form Form-5
Finished product Specification Innovator‟s specifications
Pack size & Demanded Price 1*120ml, As per DPC.
Approval status of product in Reference Not provided
Me-too status Mantin Syrup by M/s Pharmasol (Pvt) Ltd (Reg#
089890)
GMP status GMP certificate was issued on 19-05-2020 on the
basis of
inspection conducted on 13-02-2020
Remarks of the Evaluator Firm has claimed Innovator‟s specifications but
product monograph is available in USP.
nd
Decision of 272 meeting of Deferred for evidence of approval of formulation in
registration board. suspension dosage form in Reference Regulatory
Authorities.
Remarks of the Evaluator evidence of approval of applied formulation in
reference
regulatory authorities/agencies which were adopted
by the
Registration Board in its 275th meeting.
st
Decision of 321 meeting of RB Deferred for evidence of approval of applied
formulation in reference regulatory
authorities/agencies which were adopted by the
Registration Board in its 275th meeting.
Remarks of the Evaluator The firm vide letter No. DRA/028/2023 dated nil
has submitted following evidence of RRA approval;
Memantine Clonmel 10mg/ml Oral Solution
HPRA Ireland approved.
The firm initially applied for 10mg/5ml strength,

now in reply firm has mentioned strength of
10mg/ml but have not submitted revised Form-5 nor
the requisite fee. Neither firm has submitted Me-too
reference as per revised label.
Each ml contains;
Memantine Hydrochloride………………….10mg
The firm shall submit fee for correction/pre-approval change in product composition
and label as per SRO496(I)/2023 dated 17.04.2023, before issuance of registration letter.
460. Name and address of manufacturer/ M/s Maxitech Pharma Pvt. Ltd Karachi.
Applicant
Brand Name + Dosage Form + Osmin-D Suspension
Strength
Composition Each 5ml of Suspension contains:
Vitamin D…400 IU
Ossein Mineral Complex….400 mg
Diary No. Date of R & I & fee Diary No: 2749, 15/12/2016, Rs. 20,000/-
Pharmacological Group Vitamin + Mineral
Type of Form Form-5
Finished product Specification Mfg. Specs.
Approval status of product in Reference International availability not mentioned.
Me-too status Osnate-D Suspension by M/s. AGP Ltd., Karachi.
GMP status GMP inspection conducted on 21-02-2019,
concluded
with the following remarks:
Based on above observations and keeping in view
the
attitude of the management of the firm towards
constant improvement their current GMP
compliance
level is rated as Good.
Remarks of the Evaluator International availability not confirmed.
Evidence of atomic absorption spectrophotometer
confirmed
Firm has claimed in house specs but not provided
the
following documents in the light of decision of
267th RB
meeting
Product and formulation development data
Manufacturing method development and
process validation
Analytical method development and validation
against innovator’s analytical method and
innovator’s
product
Comparative pharmaceutical equivalence
against innovator’s product including comparative
dissolution profiling
Stability data of the product for accelerated and
real
time period against innovator’s product as a
reference
Decision of 269th meeting of Registration Board in its 269th meeting decided as
registration board. under:
Deferred for evidence of approval, of applied
formulation, by reference regulatory authorities as
decided in 249th meeting of Registration Board and
Minutes of 296th Meeting of Registration Board |
2190
detailed composition of ossein mineral complex.
Remarks of the Evaluator Firm provide the evidence of Me-Too product
Osnate-D Suspension registered in the name of
M/s. AGP Ltd., Karachi (Reg. No. 070854)
Complete composition of ossein mineral
complex is as under:
Ossein Mineral Complex
Corresponds to:
Calcium…85.59 mg
Phosphorus…39.61 mg
Residual mineral salts…12 mg
Collagen…107.95mg
Other proteins…32 mg
Trace Elements…Fl, Mg, Fe, Ni, Cu
Decision of 296th meeting of RB Deferred for confirmation of availability of
Atomic Absorption Spectrophotometer for
testing of these products.
submitted qualification report of atomic absorption.
RRA reference is available as approved by ANSM

of France.
Decision: Approved with Innovator’s specifcations as per following label claim:
Each 5ml of Suspension contains:
Vitamin D…400 IU
Corresponds to:
Calcium…85.59 mg
Residual mineral salts…12 mg
Collagen…107.95mg
Other proteins…32 mg
Trace Elements…Fl, Mg, Fe, Ni, Cu
Firm shal submit fee of Rs. 7,500 for pre-approval change/correction in drug product
specifications, as per SRO 496(I)/2023 dated 17.04.2023.
461. Name and address of manufacturer/ M/s Maxitech Pharma Pvt. Ltd Karachi.
Applicant
Brand Name + Dosage Form + Osmin Suspension
Strength
Composition Each 5ml of Suspension contains:
Ossein Mineral Complex………..250 mg
Diary No. Date of R & I & fee Diary No: 2748, 15/12/2016, Rs. 20,000/-
Pharmacological Group Vitamin + Mineral
Type of Form Form-5
Finished product Specification Mfg. Specs.
Approval status of product in Reference International availability not mentioned.
Me-too status Osmin Suspension by M/s Himont Pharmaceuticals.
GMP status GMP inspection conducted on 21-02-2019,
concluded
with the following remarks:
Based on above observations and keeping in view
the
attitude of the management of the firm towards
constant improvement their current GMP
compliance
level is rated as Good.
Remarks of the Evaluator International availability not confirmed.
Evidence of atomic absorption spectrophotometer
confirmed
Firm has claimed in house specs but not provided
the
following documents in the light of decision of
267th RB
meeting
Product and formulation development data
Manufacturing method development and
process validation
Analytical method development and validation
against innovator’s analytical method and
innovator’s
product
Comparative pharmaceutical equivalence
against innovator’s product including comparative
dissolution profiling
Stability data of the product for accelerated and
real
time period against innovator’s product as a
reference
Decision of 269th meeting of Registration Board in its 269th meeting decided as
registration board. under:
Minutes of 296th Meeting of Registration Board |
2191
Deferred for evidence of approval, of applied
formulation, by reference regulatory authorities as
decided in 249th meeting of Registration Board and
detailed composition of ossein mineral complex.
Remarks of the Evaluator Firm provide the evidence of Me-Too product
Ossogin Suspension registered in the name of
M/s. Himont Pharmaceuticals (Reg.no.031858)
Firm provide the complete composition of
ossein mineral complex which is as under:
Corresponds to:
Calcium….53.5 mg
Residual Mineral Salts….7.5 mg
Collagen….67.46 mg
Other proteins….20mg
Trace elements…. (Fl, Mg, Fe, Zn, Cu & Ni)
Decision of 296th meeting of RB Deferred for confirmation of availability of
Atomic Absorption Spectrophotometer for
testing of these products.
submitted qualification report of atomic absorption.
Firm has not submitted evidence of similar product

approval in RRA which was required as per
decision of 269th meeting of the Registration Board.
Decision: Deferred for evidence of approval of applied formulation in reference regulatory
authorities/agencies which were adopted by the Registration Board in its 275th meeting. The Board
further decided that the applicant shall submit the response within 1 month after publication of
the minutes, .
462. Name and address of manufacturer/ M/s. Sigma Pharma International (Pvt.) Ltd. Plot No.
Applicant E-50, North Western Industrial Zone, Bin Qasim,
Karachi (DML No. 000804)
Tablet (General) Section.
Brand Name + Dosage Form + NOVOMIT 10mg/10mg Delayed Release Tablet
Strength
Composition Each delayed release film coated tablet contains;
Doxylamine succinate (USP)…..10mg
Pyridoxine HCl (USP)…………10mg
Diary No. Date of R & I & fee Dy. No. 25245 dated 19.02.2017. Fee paid Rs.
20,000/- vide Slip No. 0741983 dated 14-12-2017,
endorsed on 19.12.2017.
Duplicate dossier:
Dy. No. 37507 dated 22.12.2022
Pharmacological Group Aminoalkyl ethers, doxylamine, combinations.
ATC Code: R06AA59
Type of Form Form-5
Finished product Specification Innovator’s Specifications
Pack size & Demanded Price As per SRO.
Approval status of product in Reference Xonvea 10 mg/10 mg gastro-resistant tablets
Regulatory Authorities (doxylamine succinate and pyridoxine
hydrochloride) - PL 16853/0147
MHRA Approved.
Me-too status Nausidox 10mg/10mg Tablet. Reg. No. 076292
M/s OBS Pakistan (Pvt.) Ltd. Karachi.
GMP status Last inspection conducted on 06.07.2022. GMP
status is good. GMP certificate valid till 05.07.2024
is submitted.
Remarks of the Evaluator -
Decision of 326th RB meeting. Deferred for evidence of bi-layer tablet

manufacturing facility.
submitted that their applied product is not bilayer so
they do not need a bilayer tableting machine.
It is further added that products approved by MHRA

and USFDA are also not bilayer. As per products
approved by RRA, it can be a single tablet that is
delayed release.
Decision: Approved.
463. Name and address of manufacturer/ M/s Ethical Loboratories Pvt Ltd, 14 KM, Multan
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 Specifications.
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.
th
Decision of 295 RB meeting. 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.
Remarks of the Evaluator The firm submitted the required undertaking and
copy
of the challan (not been endorsed by the Division of
Budget and accounts).
Decision of 313th meeting: Registration Board referred the case to QA & LT
Division to conduct GMP inspection of Firm
on priority.
Remarks of the Evaluator Submission by the firm:
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.
nd
Decision of 322 meeting 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.
Remarks of the Evaluator The vide letter No. nil dated 02.062023 has stated
that they never requested for change of formulation
from 0.1% to 0.2%, they had only revised it as per
innovator. The label requested by firm is reproduced
below;
Each ml of solution contains;
Olopatadine (as hydrochloride)…… 1 mg
Decision: Approved with following label claim;
Each ml of solution contains;
Olopatadine (as hydrochloride)…… 1 mg
464. Name and address of manufacturer/ M/s Gillman Pharmaceuticals.
Applicant 41/2-A, Phase I & II, Industrial Estate, Hattar,
Pakistan
By
M/s Aulton Pharmaceuticals.Plot No. 84/1, Block A,
Phase V, Industrial Estate, Hattar, K.P.K
Brand Name + Dosage Form + Keto 30mg/1ml Injection
Strength
Composition Each 1ml Amber Glass Ampoule Contains:
Ketorolac tromethamine…30mg
Diary No. Date of R & I & fee Dy.No 41506 dated 07-12-2018 Rs.20,000/-
Pharmacological Group NSAID
Type of Form Form-5
Finished product Specification USP Specifications
Pack size & Demanded Price 5‟s (1ml): As per SRO
Approval status of product in Approved in TGA
Me-too status Tekac Injection of M/s Sami
GMP status Panel Inspection conducted on 12-08-2017
recommended renewal of DML.
Remarks of the Evaluator Step of terminal sterilization has not been mentioned
in manufacturing outline. Clarify or justify the same.
Mention type of primary packaging material of
applied formulation whether it is Type I, Type II &
Type III glass container.
Justification on scientific grounds for addition of
5% overage in master formulation.
Decision of 295th RB meeting. Deferred for the following:
Step of terminal sterilization has not been
mentioned in manufacturing outline. Clarify or
justify the same.
Remaining fee for contract manufacturing
Updated GMP status of the applicant firm from
QA&LT Division.
stated ampoules will be terminally sterilized
Type of glass used is USP type I.
There is no overage in product, it was actually
potency adjustment based on assay of drug substance.
The reply of firm is acceptable, but initial fee

mentioned in 295th meeting is Rs. 20,000/- for
contract it should have been Rs. 50,000/-
Updated GMP status is also not submitted.
Decision: Approved with manufacturing outline as per innovator drug product.
Registration letter will be issued upon submission of following:
 Differential fee of Rs. 30,000/- for application of contract manufacturing.
 Latest GMP inspection report of drug product manufacturer conducted within last
three years.
465. Name and address of manufacturer/ M/s Gillman Pharmaceuticals.
Applicant 41/2-A, Phase I & II, Industrial Estate, Hattar,
Pakistan
By
M/s Aulton Pharmaceuticals.Plot No. 84/1, Block A,
Phase V, Industrial Estate, Hattar, K.P.K
Brand Name + Dosage Form + Summer-D 1ml Liquid Injection
Strength
Composition Each 1ml Amber Glass Ampoule Contains:
Cholecalciferol…5mg
Diary No. Date of R & I & fee Dy.No 41703 dated 07-12-2018 Rs.50,000/-
Pharmacological Group Vitamins
Type of Form Form-5
Finished product Specification USP Specifications
Pack size & Demanded Price 5‟s (1ml): As per SRO
Approval status of product in Could not be confirmed.
Me-too status Saf-D injection 5mg of Saaaf Pharmaceuticals,
GMP status Panel Inspection conducted on 12-08-2017
recommended renewal of DML.
Remarks of the Evaluator Mention type of primary packaging material of
Decision of 295th RB meeting. Deferred for the following:
applied formulation whether it is Type I, Type II
& Type III glass container.
Justification on scientific grounds for addition
of 30% overage in master formulation.
Updated GMP status of the applicant firm from
QA&LT Division.
stated that type of glass used is USP type I.
There is no overage in product, it was actually
potency adjustment based on assay of drug substance.
Updated GMP status is not submitted.

Decision: Approved with innovator’s specifications. The firm shall submit fee for
correction/pre-approval change in product specifications as per SRO496(I)/2023 dated
17.04.2023 and latest GMP inspection report of manufacturer before issuance of
466. Name and address of manufacturer/ M/s. Liven Pharmaceuticals (Pvt.) Ltd. 49-KM,
Applicant Lahore Multan Road, Phool Nagar, District kasur.
(DML No. 000881)
Liquid injection ampoule (general) Section
Brand Name + Dosage Form + PTNOL 40mg+0.4mg Injection
Strength
Composition Each injection contains;
Phloroglucnol ……………....40mg
Trimethylphloroglucinol …..0.4mg
Diary No. Date of R & I & fee Dy. No. 16269 dated 07.03.2019. Fee paid Rs.
20,000/- vide Slip No. 0782567 dated 04-03-2019,
endorsed on 05.03.2019
Pharmacological Group Other drugs for functional gastrointestinal disorders.
ATC Code: A03AX12
Type of Form Form-5
Finished product Specification Not mentioned
Approval status of product in Reference Spasfon Solution for injection in ampoule
Regulatory Authorities ANSM France Approved.
Me-too status Spasfon Injection Reg. No. 018530
M/s Himont Oharma Lahore.
GMP status Last inspection conducted on 03.07.2019
Remarks of the Evaluator i. Latest GMP certificate/inspection report is
required.
ii. Reference of finished product specifications
is required.
iii. Volume of injection needs to be defined and
also whether it will be an ampoule or vial.
Decision of 326th RB Deferred for following;
i. Submission of details whether product is
ampoule or vial along with its volume.
ii. Reference of finished product
specifications.
iii. Latest GMP inspection report/ certificate.
Remarks of the Evaluator The firm vide letter No. LVN/DRAP=PE&R/23(3)
dated nil has stated as under;
i. The product is in Glass Ampoule of 4ml
ii. Volume of injection is 4ml
iii. Reference of Finished product specifications
is Innovator’s Specifications.
The firm has not submitted fee for above revisions.
Each 4ml ampoule contains;
Phloroglucnol ……………....40mg
Trimethylphloroglucinol …..0.4mg
The firm shall submit full fee of registration for correction/pre-approval change in
product composition and label as per SRO496(I)/2023 dated 17.04.2023 along with latest
GMP inspection report conducted within last three years, before issuance of registration
letter.
Agenda of Evaluator PEC-X
Case no. 01 Registration applications for local manufacturing of (veterinary) drugs

a. New Cases
467. Name and address of manufacturer / M/s Nawal Pharmaceuticals, Plot No. 11-A, Punjab Small
Applicant Industrial Estate, Taxilla.
Brand Name +Dosage Form + Wal Fen-50% WSP
Strength
Florfenicol…500mg
Diary No. Date of R& I & fee Dy.No 20048 dated 16-07-2021 Rs.30,000/- dated 15-07-2021
(slip No. 6810249672)
Type of Form Form 5
Finished product Specification Manufacturer’s specifications
Pack size & Demanded Price 100gm, 250gm, 500gm, 1000gm, 5000gm, 10000gm,
25000gm ; Decontrolled
Me-too status Naflor Powder of M/s Nawan Laboratories (Pvt) Ltd., Karachi.
(Reg. No. 049513)
GMP status The firm was inspected on 29-10-2018 with the following
conclusion: Firm is compliant to Current Good Manufacturing
requirements with need of some improvements which have been
discussed and agreed with the management.
Remarks of the Evaluator X Oral dry powder (General) (Veterinary) Section
confirmed from GMP compliance inspection report
Shortcomings:
 Latest GMP inspection report conducted within the period
of last three years.
Decision: Approved. The firm shall submit the latest GMP inspection report conducted within the
period of last three years and fee of Rs. 7500/- for correction/pre-approval change in finished
product specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021 before
issuance of registration letter.
Brand Name +Dosage Form + Wal Cin Powder
Strength
Neomycin Sulphate…60mg
Colistin Sulphate…10mg
Chlortetracycline HCl…200mg
Spectinomycin Sulphate…20mg
(slip No. 1066563781)
Type of Form Form 5
Me-too status Streptochlor Water Soluble Powder of M/s Baariq
Pharmaceuticals, Lahore. (Reg. No. 080738)
Remarks of the Evaluator X  Oral dry powder (General) (Veterinary) Section
Shortcomings:
Decision: Referred to EWG on veterinary drugs to review therapeutic requirement keeping in view
safety, efficacy and quality parameters.
Brand Name +Dosage Form + Wal Bate W/S Powder
Strength
Amprolium HCl…200mg
Ethopabate…20mg
(slip No. 1795357743)
Pharmacological Group Anticoccidial
Type of Form Form 5
Pack size & Demanded Price 100gm, 250gm, 500gm, 1000gm, 2500gm, 5000gm, 25000gm
; Decontrolled
Me-too status Coxivet Water Soluble Powder of M/s Mylab (Pvt) Ltd,
Khankah Sharif, Bahawalpur (Reg. No.094490)
Shortcomings:
Brand Name +Dosage Form + Wal Cetamol Powder
Strength
Vitamin C…50mg
Paracetamol…200mg
Potassium Carbonate…125mg
Sodium Bicarbonate…125mg
Vitamin E…125mg
(slip No. 091565212)
Pharmacological Group Analgesic, Antipyretic, Antioxidant
Type of Form Form 5
Me-too status Paracet Water Soluble Powder of M/s Decent Pharma, Rawat,
Islamabad (Reg. No. 079826)
Shortcomings:
Brand Name +Dosage Form + Wal-Fos W/S Powder
Strength
Fosfomycin Calcium…200mg
Tylosin Tartrate…100mg
Fructose…180mg
Sodium Phosphate…150mg
Magnesium Sulphate…100mg
(slip No. 3591705670)
Pharmacological Group Antibacterial, Electrolytes
Type of Form Form 5
Me-too status Fosfotyl Powder of M/s Leads Pharma (Pvt) Ltd., Islamabad
(Reg. No. 078240)
Shortcomings:
 Firm shall submit fee of Rs.30000/- for correction in
formulation (salt form), as per notification No.F.7-11/2012-
B&A/DRAP dated 07-05-2021.
Decision: Approved with following label claim:
Each gram contains:
Tylosin as Tartrate…100mg
Fructose 1,6 diphosphate…180mg
The firm shall submit latest GMP inspection report conducted within the period of last three years
and fee of Rs. 30,000/- for salt form correction as per notification No.F.7-11/2012-B&A/DRAP dated
07-05-2021 before issuance of registration letter.
Brand Name +Dosage Form + Wal Flocin-60 W/S Powder
Strength
Oxytetracycline HCl…300mg
Florfenicol…300mg
(slip No. 2366399994)
Type of Form Form 5
Me-too status Ampronil-50 Oral Powder of M/s Westmont Pharmaceutical
Industry, Gujar Khan, Distt. Rawalpindi (Reg. No. 063747)
Remarks of the Evaluator X
 Oral dry powder (General) (Veterinary) Section
Shortcomings:
Brand Name +Dosage Form + Wal Flocin-30 W/S Powder
Strength
Florfenicol…150mg
(slip No. 7385444368)
Type of Form Form 5
Me-too status Oxy-Floro Water Soluble Powder of M/s Intervac (Pvt) Ltd.,
Sheikhupura. (Reg. No. 080726)
Shortcomings:
Brand Name +Dosage Form + Oxy Wal-950 Powder
Strength
(slip No. 423227285736)
Type of Form Form 5
Finished product Specification BP specifications
Me-too status Eter Oxytetracycline-95 Powder of M/s Eterna Pharma (Pvt)
Ltd., Mirpur, AJK. (Reg. No.109842)
Shortcomings:
period of last three years before issuance of registration letter.
Brand Name +Dosage Form + Metha Wal Water Soluble Powder
Strength
Methenamine…950mg
Vitamin B1…8mg
Vitamin B2…9.2mg
Vitamin K3…2mg
(slip No. 9469849664)
Pharmacological Group Diuretic, Antiseptic, Vitamins
Type of Form Form 5
Me-too status Urimin Water Soluble Powder of M/s Attabak Pharmaceutical
Industries, Islamabad (Reg. No. 034527)
Shortcomings:
 clarification regarding solubility of instant formulation
 latest GMP inspection report conducted within the period of last three years
The Board further decided that the applicant shall submit the response within 1 month after
publication of the minutes, .
Brand Name +Dosage Form + Wal CTC-20 W/S Powder
Strength
(slip No. 631994174951)
Type of Form Form 5
Me-too status Claratin Water Soluble Powder of M/s Attabak Pharmaceutical
Industries, Islamabad (Reg. No. 049782)
Shortcomings:
Brand Name +Dosage Form + Wal Lin 4.4% Powder
Strength
Lincomycin HCl…44mg
(slip No. 7526812042)
Type of Form Form 5
Me-too status Lincomin-44 Powder of M/s Symans Pharmaceuticals (Pvt)
Ltd., Lahore. (Reg. No. 078370)
Shortcomings:
Brand Name +Dosage Form + Ammar Wal 1% Powder
Strength
Amantadine HCl…10mg
(slip No. 68477338)
Pharmacological Group Antiviral
Type of Form Form 5
Me-too status Amantabak 10% Powder of M/s Attabak Pharmaceuticals,
Islamabad (Reg. No.075697)
Shortcomings:
Decision: Registration Board deferred the case forfurther delibeation and directed PE&R Division
to present working paper on international regulatory status of “Amantadine Drug for Veterinary
use”, in upcoming Board meeting.
Brand Name +Dosage Form + Wal Tysin 10% Premix
Strength
Tylosin Phosphate…100mg
(slip No. 71661413388)
Type of Form Form 5
Me-too status Lincomiks 10 Powder of M/s Eterna Pharma (Pvt) Ltd., Mirpur,
AJK (Reg. No. 113518)
Shortcomings:
Brand Name +Dosage Form + Wal Mycin W/S Powder
Strength
Florfenicol…150mg
(slip No. 895851839249)
Type of Form Form 5
Me-too status Neo Flor Water Soluble Powder of M/s Farm Aid Group,
Haripur. (Reg. No. 087961)
Shortcomings:
Brand Name +Dosage Form + Tiamu Wal Powder
Strength
Tiamulin Hydrogen Fumarate Eq. to Tiamulin Base…450mg
(slip No. 58229763)
Type of Form Form 5
Me-too status Tiamubak 45% Oral Powder of M/s Attabak Pharmaceuticals,
Islamabad. (Reg. No. 048170)
Shortcomings:
Brand Name +Dosage Form + Stonis-550 W/S Powder
Strength
Florfenicol…1mg
Neomycin Sulphate…1.5mg
(slip No. 956924200)
Type of Form Form 5
Me-too status Ofencin Oral Water Soluble Powder of M/s D-Maarson
Pharmaceuticals, Rawat, Islamabad (Reg. No. 097869)
Shortcomings:
Brand Name +Dosage Form + Racol-60 W/S Powder
Strength
Colistin Sulphate…6,000,000 IU
(slip No. 79343093075)
Type of Form Form 5
Me-too status Neflorex 60 Water Soluble Powder of M/s Eterna Pharma (Pvt)
Ltd., Mirpur, AJK (Reg. No. 113529)
Shortcomings:
Brand Name +Dosage Form + Spira Wal Powder
Strength
Spectinomycin HCl…75mg
Spiramycin Adipitate…25mg
Bromhexine HCl…5mg
(slip No. 740102526)
Type of Form Form 5
Me-too status Spiralinc-B Powder of M/s Attabak Pharmaceuticals,
Shortcomings:
Brand Name +Dosage Form + Diarro Wal Powder
Strength
Composition Each gm contains:
Neomycin sulphate…33.33mg
Streptomycin sulphate…33.33mg
Sulphaguanidine…0.33gm
Kaolin……………0.33gm
Pectin…………….33.33mg
Bismuth Subnitrate…0.167gm
Vitamin A………….6666.67 I.U
(slip No. 628911632061)
Pharmacological Group Antibacterial, Anti diarrheal, Vitamin
Type of Form Form 5
Pack size & Demanded Price 12gm, 100gm, 250gm, 500gm, 1000gm, 5000gm, 10000gm,
Me-too status Diarroban Powder of M/s Star Labs, Lahore. (Reg. No. 026438)
Shortcomings:
Brand Name +Dosage Form + Wal Gest Powder
Strength
Propionic Acid Calcium…250mg
Propionic Acid Sodium…400mg
Acetanilide…150mg
Magnesium Oxide…125mg
Iron II Sulphate…0.4mg
Zince sulphate...0.1mg
Magnesium Sulphate…0.2mg
Copper Sulphate…0.45mg
Cobalt Sulphate…0.4mg
Sodium Molybdate…0.1mg
Sodium Chloride…20mg
(slip No. 3899363984)
Pharmacological Group Digestive supplement
Type of Form Form 5
Me-too status Anigest Powder of M/s Mylab (Pvt) Ltd. Khanqah Sharif,
Bahawalpur (Reg. No. 073906)
Shortcomings:
 Confirmation of testing facility
 Latest GMP inspection report conducted within the period of last three years.
 Confirmation of relevant testing facility for minerals i.e., Atomic absorption
spectrophotometer.
Brand Name +Dosage Form + Wal Grow W/S Powder
Strength
Vitamin A…0.8mg
Vitamin D3…0.16mg
Vitamin E…0.38mg
Vitamin B1...1mg
Vitamin B2…1.25mg
Vitamin B12…1mg
Vitamin B3…6.25mg
Calcium Chloride…23mg
Zinc Sulphate…2.17mg
Maganese Sulphate…10mg
Potassium Iodide…0.5mg
Sodium Selenite…0.01mg
DCP (Phosphorous)…150mg
Vitamin B6...4mg
(slip No. 266251072927)
Pharmacological Group Multivitamins and minerals supplement
Type of Form Form 5
Me-too status White Gold Powder of M/s Leads Pharma (Pvt) Ltd Islamabad
(Reg. No. 058842)
Shortcomings:
 Confirmation of relevant testing facility
Confirmation of relevant testing facility for minerals i.e., Atomic absorption spectrophotometer.
488. Name and address of manufacturer / M/s Evergreen Pharmaceuticals, 69-70/B, Main Glaxo Town,
Applicant Industrial Area, 20th km Ferozepur Road, Lahore.
Brand Name +Dosage Form + Ketogen Injection 100ml
Strength
Ketoprofen…100mg
(slip No. 2916250106)
Type of Form Form 5
Pack size & Demanded Price 100ml vial: Decontrolled
Me-too status Ketorise Injection (100ml) of M/s Biorise Pharmaceuticals,
Multan. (Reg. No.113398)
GMP status Inspection conducted on 11-03-2022 concludes satisfactory
level of GMP compliance.
X
Remarks of the Evaluator Shortcomings:
 Approval of Injectable (General) Veterinary section by
CLB
489. Name and address of manufacturer / M/s Sanna Laboratories, 1019-B, P.S.I.E, Sargodha Road,
Applicant Faisalabad.
Brand Name +Dosage Form + Tilcos-25 Oral Liquid
Strength
Tilmicosin…250mg
(slip No. 2406299309)
Type of Form Form 5
Pack size & Demanded Price 50ml, 100ml, 250ml, 500ml, 1000ml, 2500ml, 5000ml:
Decontrolled
Me-too status Motil Liquid of M/s Eterna Pharma (Pvt) Ltd., Mirpur, AJK.
(Reg. No. 113537)
GMP status
Remarks of the Evaluator X Oral Liquid (Non-Antibiotic/ Antibiotic) (Veterinary)
Section confirmed from panel inspection report conducted on
10-01-2019 for grant of cGMP certificate.
Shortcomings:
Decision: Approved.The firm shall submit following before issuance of registration letter:
 Fee of Rs. 30,000/- for correction/pre-approval change in formulation (salt form), and finished
product specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
490. Name and address of manufacturer / M/s Prix Pharmaceutica Pvt Ltd., Plot No 5, Pharmacity, 30-
Applicant km Multan Road, Lahore.
Brand Name +Dosage Form + Primec Super Injection 10ml
Strength
Ivermectin…20mg
(slip No. 75176219429)
Pharmacological Group Anti-parasitic
Type of Form Form 5
Pack size & Demanded Price 10ml: Decontrolled
Me-too status Selmec Injection (10ml) of M/s Selmore Pharmaceutical (Pvt)
Ltd., Lahore (Reg. No. 071087)
GMP status
Remarks of the Evaluator X Veterinary Liquid Injectable (General) section confirmed
vide Letter No. F. 1-9/2000-Lic dated 29-06-2012.
Shortcomings:
Strength
Ivermectin…20mg
(slip No. 70904660958)
Type of Form Form 5
Me-too status Ivermec 2% Injection (50ml) of M/s Grand Pharma (Pvt) Ltd.,
GMP status
Remarks of the Evaluator X Veterinary Liquid Injectable (General) section confirmed
vide Letter No. F. 1-9/2000-Lic dated 29-06-2012.
Shortcomings:
Strength
Ivermectin…20mg
(slip No. 03648779839)
Type of Form Form 5
Me-too status Could not be confirmed in the applied pack size
GMP status
Remarks of the Evaluator X Shortcomings:
 Evidence of applied formulation/drug already approved by
DRAP (generic / me-too status) alongwith registration
number, brand name and name of firm.
 Confirmation of relevant manufacturing facility
 Evidence of applied formulation/drug already approved by DRAP (generic / me-too status)
alongwith registration number, brand name and name of firm.
 Confirmation of relevant manufacturing facility.
Brand Name +Dosage Form + Oxyway 5 Injection 250ml
Strength
Oxytetracycline HCl 53.91mg eq. to Oxytetracycline
……50mg
(slip No. 75961978247)
Type of Form Form 5
Finished product Specification USP specifications
GMP status
Brand Name +Dosage Form + Ectomec 10 Injection 250ml
Strength
Doramectin…10mg
(slip No. 57149996568)
Type of Form Form 5
Me-too status Doramec-DMG Injection (250ml) of M/s Leads Pharma (Pvt)
Ltd., Islamabad. (Reg. No. 043544)
GMP status
Brand Name +Dosage Form + Allevia 20% Injection 50ml
Strength
Sodium Iodide…200mg
(slip No. 7327494652)
Pharmacological Group Ionic compound
Type of Form Form 5
GMP status
 Evidence of approval of applied formulation, with same
pack size as applied, in reference regulatory
authorities/agencies
 Evidence of approval of applied formulation, with same pack size as applied, in reference
regulatory authorities/agencies
Brand Name +Dosage Form + Allevia 20% Injection 100ml
Strength
Sodium Iodide…200mg
(slip No. 50847449403)
Pharmacological Group Ionic compound
Type of Form Form 5
GMP status
 Evidence of approval of applied formulation, with same
pack size as applied, in reference regulatory
authorities/agencies
 Evidence of approval of applied formulation, with same pack size as applied, in reference
regulatory authorities/agencies
497. Name and address of manufacturer / M/s Lucky Core Industries Limited, 45-KM, off
Applicant Multan Road, Lahore.
(Formerly, ICI Pakistan Limited Life Sciences)
Brand Name +Dosage Form + Proxifen Injection 50ml
Strength
Ketoprofen…100mg
(slip No. 70534384404)
Type of Form Form 5
Pack size & Demanded Price 50ml; Decontrolled
Me-too status Ketoject Injection (20ml, 50ml, 100ml) of M/s Selmore
Pharmaceuticals (Pvt) Ltd., Lahore. (Reg. No. 043141)
GMP status cGMP certificate dated 30-03-2021 based on inspection
Remarks of the Evaluator X  Liquid Injectable (SVP) Veterinary section granted vide
letter No. F.1-41/2007-Lic dated 10-07-2017
 The firm shall submit revised form-5 with its new title along
with fee Rs. 30,000/- for change of title of the firm.
Strength
Ketoprofen…100mg
(slip No. 82678962247)
Type of Form Form 5
The firm shall submit revised form-5 with its new title along
Strength
Ketoprofen…100mg
(slip No. 77703107862)
Type of Form Form 5
 Liquid Injectable (SVP) Veterinary section granted vide
 The firm shall submit revised form-5 with its new title along
Brand Name +Dosage Form + Enisol-10 Injection 10ml
Strength
Enrofloxacin…100mg
(slip No.30214461)
Type of Form Form 5
Finished product Specification As per innovator’s specifications
Me-too status Enflox-10% Injection (10ml) of M/s Univet Pharmaceuticals,
Rawalpindi. (Reg. No. 112210)
 The firm has submitted revised form-5 with its new title
along with fee Rs. 30,000/- (slip No.82386235066) for
change of title of the firm.
Decision: Approved.
Strength
(slip No.14734011547)
Type of Form Form 5
Decision: Approved.
Strength
(slip No.703448758)
Type of Form Form 5
Decision: Approved.
Brand Name +Dosage Form + Oxymax Injection 50ml
Strength
Oxytetracycline Dihydrate eq. to Oxytetracycline…300mg
Flunixin Meglumine…20mg
(slip No.204885083)
Pharmacological Group Antibiotic/ anti-inflammatory
Type of Form Form 5
Me-too status Mine Injection (50ml) of M/s. Kayans Pharmaceuticals, Rawat,
Rawalpindi (Reg. No. 111570)
Remarks of the Evaluator X 
Liquid Injectable (SVP) Veterinary section granted vide
along with fee Rs. 30,000/- (slip No.98089578) for change
of title of the firm.
 Correction in formulation (label claim in line with reference
product) is required
Each ml contains:
Oxytetracycline Dihydrate eq. to Oxytetracycline…300mg
Flunixin as Meglumine…20mg
Brand Name +Dosage Form + Marbocin Injecion 50ml
Strength
Marbofloxacin…100mg
(slip No.6266343225)
Type of Form Form 5
Me-too status Marbo-Vetz 10% Injection (50ml) of M/s. Vetz
Pharmaceuticals (Private) Limited., Kotri Sindh. (Reg. No.
099431)
Decision: Approved.
505. Name and address of manufacturer / M/s Baariq Pharmaceuticals, Plot # 600, Sundar Industrial
Applicant Estate, Sundar Raiwind Road, Lahore.
Brand Name +Dosage Form + Tylobar-100% Water Soluble Powder
Strength
(slip No.10962887283)
Type of Form Form 5
Pack size & Demanded Price 100gm, 250gm, 500gm, 1000gm, 2500gm, 5000gm, 10000gm,
25000gm: As per SRO
Me-too status Tyflox Oral Powder of M/s ICI Pakistan Limited,
Life Sciences, Lahore (Reg. No. 099364)
GMP status Vet Oral Powder (II) section confirmed vide report based on
panel inspection conducted on 28-08-2018 for GMP
compliance.
X
 Latest GMP inspection report (conducted within the period
of last three years).
 The firm shall submit fee Rs. 30,000/- for correction in
formulation (label claim in line with reference product).
Each gram contains:
and fee of Rs. 30,000/- for correction/pre-approval change in formulation (salt form), and finished
product specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.before
506. Name and address of manufacturer / M/s ISIS Pharmaceuticals & Chemical Works, 25/1-3, Sector
Applicant 12-C, North Karachi Industrial Area, Karachi.
Brand Name +Dosage Form + Oxytocin Injection (10 IU/ml) 500ml
Strength
Oxytocin…10 IU
(slip No. 861034407386)
Pharmacological Group Hormone
Type of Form Form 5
Me-too status Oxytovetz Injection (500ml) of M/s Vetz Pharmaceuticals
(Private) Limited., Kotri Sindh. (Reg. No. 111471)
GMP status Inspection conducted on 03-02-2022 concluded good level of
GMP compliance.
X
 Provide conversion of Oxytocin from IU to grams
 Confirmation of relevant manufacturing facility i.e.
Injectable Hormone (Veterinary) (LVP) section
 Confirmation of relevant manufacturing facility i.e. Injectable Hormone (Veterinary) (LVP)
section
 conversion of Oxytocin from IU to grams.
Strength
Oxytocin…5 IU
(slip No. 5433809555)
Type of Form Form 5
GMP compliance.
X
 Provide conversion of Oxytocin from IU to grams
DRAP with same pack size as applied (generic / me-too
status) alongwith registration number, brand name and
name of firm.
Injectable Hormone (Veterinary) (LVP) section
 conversion of Oxytocin from IU to grams
 evidence of applied formulation/drug already approved by DRAP with same pack size as
applied (generic / me-too status) alongwith registration number, brand name and name of firm.
 confirmation of relevant manufacturing facility i.e. Injectable Hormone (Veterinary) (LVP)
section.
Brand Name +Dosage Form + Leucole S Injection 50ml
Strength
Spiramycin adipate…125mg
(slip No. 9109408338)
Type of Form Form 5
Me-too status Adicin Injection (50ml) of M/s Mallard Pharmaceutical (Pvt)
Ltd., Multan. (Reg. No. 109801)
GMP compliance.
Remarks of the Evaluator X  Liquid Injection (Veterinary) section confirmed vide
letter No. F. 2-11/2005-Lic (Vol-I) dated 15-06-2021.
Decision: Approved. The firm shall submit fee of Rs. 7500/- for correction/pre-approval change in
finished product specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021
Strength
(slip No. 69581870255)
Type of Form Form 5
Me-too status Piram Injection (100ml) of M/s Attabak Pharmaceuticals,
GMP compliance.
 Liquid Injection (Veterinary) section confirmed vide
Strength
(slip No. 765351604398)
Type of Form Form 5
Me-too status Lispiracin Injection (10ml) of M/s Leads Pharma (Pvt) Ltd.,
GMP compliance.
Strength
Oxytocin…20 IU
(slip No. 157958565706)
Type of Form Form 5
GMP compliance.
Remarks of the Evaluator X Registration Board in its 313th meeting, considered and
endorsed the decision of Expert Working Group on
Veterinary Drugs
The Expert Working Group on Veterinary Drugs deliberate the
case and decided to allow for granting multidose vials for
Oxytocin as per following details:
 Oxytocin .... 10 UI upto 500ml as per Spanish authority
approval or any pack size available
in any other RRA.
 Oxytocin .... 20 UI upto 50ml as per Australian
Pesticides and Veterinary medicine Authority
approval or any pack size available in any other RRA.
Decision: Deferred for submission of fill volume as per recommendations of the Expert Working
Group on Veterinary Drugs, presented in 313th meeting of Registration Board.
Brand Name +Dosage Form + Isketo Injection 10ml
Strength
Ketoprofen…100mg
(slip No. 77983104)
Type of Form Form 5
Me-too status Ketoexel 100 Injection (10ml) Of M/s Mediexcel
Pharmaceuticals, Islamabad. (Reg. No. 106694)
GMP compliance.
Strength
Ketoprofen…100mg
(slip No. 10792384591)
Type of Form Form 5
GMP compliance.
Strength
Ketoprofen…100mg
(slip No. 718116033117)
Type of Form Form 5
GMP compliance.
Brand Name +Dosage Form + Marfocin Injection 50ml
Strength
(slip No. 96427930)
Type of Form Form 5
Me-too status Marbo-Vetz 10% Injection (50ml) Of M/s VETZ
099431)
GMP compliance.
Strength
(slip No. 70110386409)
Type of Form Form 5
099430)
GMP compliance.
Strength
(slip No. 3742617210)
Type of Form Form 5
099432)
GMP compliance.
Brand Name +Dosage Form + Istal Injection 20ml
Strength
Aceclofenac…25mg
(slip No. 79358945)
Type of Form Form 5
Me-too status Aceclovetz Injection (20ml) of M/s VETZ Pharmaceuticals
GMP compliance.
Decision: Referred to Ministry of Food Security & Research for opinion regarding therapeutic
requirement of applied veterinary drug, keeping in view safety & efficacy parameters.
Strength
Aceclofenac…25mg
(slip No. 0011250561)
Type of Form Form 5
Me-too status Aklonac Injection (50ml) of M/s Manhattan Pharma, Karachi.
(Reg. No. 106765)
GMP compliance.
Strength
Aceclofenac…25mg
(slip No. 591448067924)
Type of Form Form 5
GMP compliance.
X
Remarks of the Evaluator Liquid Injection (Veterinary) section confirmed vide letter
No. F. 2-11/2005-Lic (Vol-I) dated 15-06-2021.
Shortcomings:
 Evidence of applied formulation/drug already approved
by DRAP with same pack size as applied (generic /
me-too status) alongwith registration number, brand
name and name of firm.
Brand Name +Dosage Form + Isxine Injection 10ml
Strength
Flunixine Maglumine…50mg
(slip No. 63250434590)
Pharmacological Group Diuretic
Type of Form Form 5
Me-too status Floonix Injection (10ml) of M/s Kayans Pharmaceuticals,
Rawat, Rawalpindi (Reg. No. 112246)
GMP compliance.
formulation (label claim in line with reference product) as
per notification No.F.7-11/2012-B&A/DRAP dated 07-05-
2021.
Each ml contains:
Flunixine as Maglumine…50mg
The firm shall submit fee of Rs. 30,000/- for correction/pre-approval change in formulation and
Strength
(slip No. 319960379171)
Type of Form Form 5
GMP compliance.
2021.
Each ml contains:
Strength
(slip No. 5130295215)
Type of Form Form 5
GMP compliance.
2021.
Each ml contains:
Brand Name +Dosage Form + Is-Ade Injection 50ml
Strength
Vitamin A Palmitate…80,000 IU
Vitamin D3…40,000 IU
Vitamin E…20mg
(slip No. 0567760383)
Pharmacological Group Multivitamin
Type of Form Form 5
Me-too status Vitamall Injection (50ml) of M/s Mallard Pharmaceuticals (Pvt)
GMP compliance.
Strength
Vitamin E…20mg
(slip No. 777872872243)
Type of Form Form 5
Me-too status Vital-3 Injection (10ml) of M/s Selmore Pharmaceuticals (Pvt)
Ltd., Lahore. (Reg. No. 049635)
GMP compliance.
Strength
Vitamin E…20mg
(slip No. 1640330792)
Type of Form Form 5
Me-too status Pro Vade Injection (100ml) of M/s Nawal Pharmaceuticals,
Taxila-Rawalpindi. (Reg. No. 113608)
GMP compliance.
Brand Name +Dosage Form + Is-Ade Plus Injection 10ml
Strength
Vitamin A…100,000 IU
Vitamin E…40mg
(slip No. 6768206298)
Type of Form Form 5
Me-too status Could not be confirmed in the applied strength and pack
size
GMP compliance.
name of firm.
safety, efficacy and quality parameters
Strength
Vitamin E…40mg
(slip No. 646015370135)
Type of Form Form 5
Me-too status Could not be confirmed in the applied strength and apck
size
GMP compliance.
name of firm.
Strength
Vitamin E…40mg
(slip No. 59220361316)
Type of Form Form 5
Me-too status Could not be confirmed in the applied strength and pack
size
GMP compliance.
Remarks of the Evaluator X Liquid Injection (Veterinary) section confirmed vide letter
No. F. 2-11/2005-Lic (Vol-I) dated 15-06-2021.
Shortcomings:
name of firm.
Brand Name +Dosage Form + Isbectin-T Oral Liquid
Strength
Albendazole…100mg
Triclabendazole…120mg
Ivermectin…2mg
(slip No. 898886931)
Pharmacological Group Anthelmintic
Type of Form Form 5
Pack size & Demanded Price 50ml,250ml,500ml: Decontrolled
Me-too status Triverzole Oral Drench of M/s Biorise Pharmaceuticals,
Multan. (Reg. No. 109985)
GMP compliance.
Remarks of the Evaluator X Liquid Syrup (Veterinary) section confirmed vide letter No.
F. 2-11/2005-Lic (Vol-I) dated 15-06-2021.
Decision: Approved. The firm shall submit fee Rs. 7,500/- for correction/pre-approval change in
531. Name and address of manufacturer / M/s Ras Pharmaceuticals Pvt Ltd.,25-km, Lahore Road,
Applicant Multan
Brand Name +Dosage Form + Atoras Injection 100ml
Strength
Atropine Sulphate…1mg
(slip No. 20416728742)
Pharmacological Group Anticholinergic
Type of Form Form 5
Pack size & Demanded Price 100ml; N/A
Me-too status Atrofin Injection (100ml) of M/s A&K Pharmaceutical,
Faisalabad. (Reg. No. 102102)
GMP status Last GMP inspection is conducted on 16-10-2018 and the report
concludes that firm was considered to be operating at fair level
of GMP compliance.
Remarks of the Evaluator X  Liquid Injection (General) (Veterinary) section
confirmed vide letter No. F. 1-46/2010-Lic (Vol-I) dated
27-05-2021.
Shortcomings:
of last three years)
Decision: Approved. The firm shall submit latest GMP inspection report conducted within the
Applicant Multan
Brand Name +Dosage Form + Meparas Injection 50ml
Strength
Mepyramine Maleate…50mg
(slip No. 8549203524)
Pharmacological Group Antihistamine
Type of Form Form 5
Finished product Specification As per Innovator’s specifications
Me-too status Meprax Injection (50ml) of M/s Mylab (Pvt) Ltd, Khankah
Sharif, Bahawalpur. (Reg. No. 112258)
of GMP compliance.
 Liquid Injection (General) (Veterinary) section
27-05-2021.
 Target species:
i. Cattle and horses
ii. Sheep
Shortcomings:
Applicant Multan
Brand Name +Dosage Form + Fluximin Injection 50ml
Strength
(slip No. 690436359340)
Pharmacological Group Analgesic, anti-inflammatory
Type of Form Form 5
Me-too status FM-50 Injection (50ml) of M/s Grand Pharma (Pvt) Ltd.,
of GMP compliance.
27-05-2021.
Shortcomings:
Each ml contains:
Flunixin as Maglumine…50mg
and fee of Rs. 30,000/- for correction/pre-approval change in formulation as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021 before issuance of registration letter.
Applicant Multan
Brand Name +Dosage Form + Rasquon Injection 20ml
Strength
Buparvaquone…50mg
(slip No. 81742077545)
Pharmacological Group Anti-protozoal
Type of Form Form 5
Me-too status Empilex Injection (20ml) of M/s Manhattan Pharma, Karachi.
(Reg. No. 109090)
of GMP compliance.
 Liquid Injection (General) (Veterinary) section
27-05-2021.
Shortcomings:
Applicant Multan
Brand Name +Dosage Form + Heparas Injection 50ml
Strength
Phenoxy-2 Methyl-2 Propionic Acid…100mg
(slip No. 6784878018)
Pharmacological Group Liver tonic
Type of Form Form 5
Me-too status Bio-Hepa Injection (50ml) of M/s Biorise Pharmaceuticals,
Multan. (Reg. No. 112182)
of GMP compliance.
27-05-2021.
Shortcomings:
Applicant Multan
Brand Name +Dosage Form + Tyloras Injection 100ml
Strength
(slip No. 487832281004)
Type of Form Form 5
Me-too status Tylosin 20% Solution for Injection (100ml) of M/s Chakwal
Pharma International, Lahore. (Reg. No. 111212)
of GMP compliance.
27-05-2021.
Shortcomings:
Each ml Contains:
and fee of Rs. 30,000/- for correction/pre-approval change in formulation as per notification No.F.7-
Applicant Multan
Brand Name +Dosage Form + Gentosin Injection 100ml
Strength
Gentamycin as Sulphate…50mg
(slip No. 84611691)
Type of Form Form 5
Me-too status Tylogent Injection (100ml) of M/s Breeze Pharma Islamabad
(Reg. No. 059108)
of GMP compliance.
27-05-2021.
Shortcomings:
Applicant Multan
Brand Name +Dosage Form + Dermaras-25 Injection 50ml
Strength
Pheniramine Maleate…25mg
(slip No. 3780931269)
Pharmacological Group Antihistamine
Type of Form Form 5
Me-too status Ann-Vil Injection (50ml) of M/s Venus Pharma, Lahaore (Reg.
No.035158)
of GMP compliance.
27-05-2021.
Shortcomings:
539. Name and address of manufacturer / M/s Sanna Laboratories, 1019-B, P.S.I.E, Sargodha Road,
Applicant Faisalabad.
Brand Name +Dosage Form + TG-150 Liquid Injection 100ml
Strength
Gentamycin…50mg
(slip No. 94333830013)
Type of Form Form 5
Me-too status Tylogent Injection (100ml) of M/s Breeze Pharma Islamabad
(Reg. No. 059108)
GMP status
Remarks of the Evaluator X Oral Liquid (Non-Antibiotic/ Antibiotic) (Veterinary)
Section confirmed from panel inspection report conducted on
10-01-2019 for grant of cGMP certificate.
Shortcomings:
Each ml Contains:
Gentamycin…50mg
The firm shall submit latest GMP inspection report conducted within the period of last three years,
and fee of Rs. 30,000/- for correction/pre-approval change in formulation and finished product
specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021 before issuance of
540. Name and address of manufacturer / M/s Elko Organization Pvt Ltd., Plot No.27 & 28, Sector 12-B,
Applicant North Karachi, Industrial Area, Karachi.
Brand Name +Dosage Form + Brics RTU Injection 10ml
Strength
Ceftiofur as HCl…50mg
(slip No. 74086201075)
Type of Form Form 5
Me-too status Jexinel Injection (10ml) of M/s International Pharma Labs
Lahore (Reg. No.053979)
GMP status Inspection conducted on 16-01-2020 concluded fair level of
GMP compliance in veterinary sections.
 Latest GMP inspection report (conducted within the
period of last three years).
 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.
Brand Name +Dosage Form + El-Flostin Solution
Strength
Florfenicol…230mg
Colistin Sulphate…0.5 MIU
(slip No. 2504483965)
Type of Form Form 5
Pack size & Demanded Price 1000ml and 5000ml: Decontrolled
Me-too status Flatirox Oral Solution of M/s Vetrox Pharmaceutical Pvt Ltd,
Toba Tek Singh (Reg. No. 112361)
X
Remarks of the Evaluator Oral Liquid (G) Veterinary section confirmed vide panel
inspection dated 22-08-2022 for renewal of DML.
Shortcomings:
 Conversion of Colistin Sulphate from MIU to grams
Decision: Approved. Firm shall submit the following before issuance of registration letter:
 latest GMP inspection report conducted within the period of last three years.
 conversion of Colistin Sulphate from MIU to grams.
 fee of Rs. 7500/- for correction/pre-approval change in finished product specifications as per
Brand Name +Dosage Form + Enrocol Oral Solution 100ml
Strength
(slip No. 692841977)
Type of Form Form 5
Me-too status ET-Enrocamallin Oral Liquid of M/s Eterna Pharma (Pvt)
Ltd.,Mirpur, AJK (Reg. No. 112147)
Remarks of the Evaluator X Oral Liquid (G) Veterinary section confirmed vide panel
inspection dated 22-08-2022 for renewal of DML.
Shortcomings:
 Conversion of Colistin Sulphate from MIU to grams
 conversion of Colistin Sulphate from MIU to grams.
543. Name and address of manufacturer / M/s Avicenna Laboratories, 14-Km Sheikhupura Faisalabad
Applicant Road Bhikki, Sheikhupura
Brand Name +Dosage Form + Diarrocina Powder
Strength
Composition Each gram Contains:
Neomycin sulphate…33.33mg
Streptomycin sulphate…33.33mg
Sulphaguanidine…0.33gm
Kaolin…0.33gm
Pectin…33.33mg
Vitamin A Acetate…6666.67 I.U
(slip No. 79451330)
Type of Form Form 5
Pack size & Demanded Price 12gm: Decontrolled
Me-too status Diarroban Powder of M/s Star Labs Lahore (Reg. No. 026438)
GMP status
Remarks of the Evaluator X General Powder section confirmed from panel inspection
report for renewal of DML based on inspection conducted on
22-10-2018.
Shortcomings:
 Conversion of Vitamin A Acetate from IU to grams
Decision: Approved. Firm shall submit following before issuance of registration letter:
 Conversion of Vitamin A Acetate from IU to grams.
Brand Name +Dosage Form + Clomet Suspension
Strength
Closantel…50mg
Ivermectin…2mg
(slip No. 44684944172)
Type of Form Form 5
GMP status
Remarks of the Evaluator X General Liquid section confirmed from panel inspection report
for renewal of DML based on inspection conducted on 22-10-
2018.
Shortcomings:
 evidence of applied formulation/drug already approved by DRAP (generic / me-too status)
The applicant shall submit the response within 1 month after publication of the minutes, .
Brand Name +Dosage Form + Feverceena Oral Solution
Strength
Meloxicam…7.50mg
Paracetamol…10mg
(slip No. 869217749)
Pharmacological Group Antirheumatic/ Anti-inflammatory
Type of Form Form 5
GMP status
2018.
Shortcomings:
Brand Name +Dosage Form + Piperacena Suspension
Strength
Piperazine…10mg
(slip No. 3900451398)
Type of Form Form 5
Me-too status Could not be confirmed in the applied strength
GMP status
2018.
Shortcomings:
The applicant shall submit the response within 1 month after publication of the minutes, .
Brand Name +Dosage Form + Fendaceena Suspension
Strength
Fenbendazole…150mg
(slip No.8609770263)
Type of Form Form 5
Finished product Specification BP Vet specifications
Me-too status Fenbak 15 Suspension of M/s Attabak Pharmaceuticals,
Plot # 5c, I-10/3, Industrial Area, Islamabad.(Reg. No. 062181)
GMP status
2018.
Shortcomings:
Decision: Approved. Firm shall submit latest GMP inspection report conducted within the period
of last three years before issuance of registration letter.
Brand Name +Dosage Form + Avesantal Suspension
Strength
Closantel as Sodium Dihydrate…50mg
(slip No. 90258150)
Type of Form Form 5
Finished product Specification BP Vet specifications
Me-too status Clant Oral Suspension of M/s Elko Organization (Private) Ltd.,
Karachi. (Reg. No. 075649)
GMP status
2018.
Shortcomings:
of last three years before issuance of registration letter.
Brand Name +Dosage Form + Sulphacina Suspension
Strength
Trimethoprim…80mg
Sulphadiazine…400mg
(slip No. 14876558732)
Type of Form Form 5
Me-too status NES-Bromine ET Oral Suspension of M/s Eterna Pharma (Pvt)
Ltd., Mirpur, AJK. (Reg. No. 113514)
GMP status
2018.
Shortcomings:
of last three years and fee of Rs. 7500/- for correction/pre-approval change in finished product
Brand Name +Dosage Form + Deworcena Suspension
Strength
Oxfendazole…22.65mg
(slip No. 6911223688)
Type of Form Form 5
Me-too status Hitverm Drench of M/s Manhattan Pharma, Karachi. (Reg. No.
106767)
GMP status
2018.
Shortcomings:
Brand Name +Dosage Form + Avifen Plus Suspension
Strength
Fenbendazole…25mg
Selenium Sulphide…0.40mg
(slip No. 636927857)
Type of Form Form 5
Pack size & Demanded Price 50ml, 100ml, 200ml, 500ml, and 1000ml: Decontrolled
GMP status
2018.
 The firm has submitted list of equipments for confirmation
of testing facility (HPLC, FTIR, Flame photometer, UV
spectrophotometer)
Shortcomings:
Brand Name +Dosage Form + Avizol Granules
Strength
Albendazole…200mg
(slip No. 5642010294)
Type of Form Form 5
Me-too status Alzo-20 Powder of M/s S.J & G Fazul Ellahie (Pvt.) Ltd,
GMP status
22-10-2018.
Shortcomings:
Brand Name +Dosage Form + Cennagest Powder
Strength
Propionic Acid Calcium…250mg
Propionic Acid Sodium…400mg
Acetanilide…150mg
Magnesium Oxide…125mg
Iron II Sulphate…0.40mg
Zinc Sulphate...0.10mg
Magnesium Sulphate…0.20mg
Sodium Molybdate…0.10mg
(slip No. 90486083)
Pharmacological Group Nutritional supplement
Type of Form Form 5
Me-too status Evegest Oral Powder of M/s Evergreen Pharmaceuticals,
Lahore. (Reg. No. 093833)
GMP status
22-10-2018.
of testing facility (HPLC, FTIR, Flame photometer, UV
spectrophotometer)
Shortcomings:
Brand Name +Dosage Form + Triclacina Suspension
Strength
Albendazole…100mg
Ivermectin…2mg
(slip No. 38525948118)
Type of Form Form 5
Pack size & Demanded Price 100ml, 500ml, and 1000ml: Decontrolled
GMP status
2018.
Shortcomings:
 Ivermectin …2gm is mentioned on cover letter while
Ivermectin …0.2gm /100ml is mentioned in label claim on
Form-5; clarification regarding applied strength is required.
 Accordingly provide evidence of applied formulation/drug
already approved by DRAP (generic / me-too status)
alongwith registration number, brand name and name of
firm.
 Clarification regarding applied strength since varied composition si mentione in coveing letter
and submitted Form 5.
Brand Name +Dosage Form + Trimectin Suspension
Strength
Composition Each 100ml Contains:
Triclabendazole…5g
Ivermectin…100mg
(slip No. 798417062682)
Type of Form Form 5
Me-too status Trimall Oral Suspension of M/s Mallard Pharmaceuticals (Pvt)
GMP status
2018.
Shortcomings:
556. Name and address of manufacturer / M/s Mili Vet Pharmaceuticals Pvt Ltd, Kamas Off 2Km,
Applicant Multalib Road, Near Sundar Industrial Estate, Raiwind Road,
Lahore.
Brand Name +Dosage Form + Mili Calfosfocin Oral Powder
Strength
Fructose 1,6 Diphosphate…180mg
Magnesium Phosphate…100mg
Sodium Chloride q.s.…1000mg
(slip No. 3877364599)
Pharmacological Group Antibiotics-Electrolytes
Type of Form Form 5
Pack size & Demanded Price 50gm, 100gm, 250gm, 500gm, 1000gm and 5000gm:
Decontrolled
Me-too status Fofact Powder of M/s Univet Pharmaceuticals,
GMP status Panel inspection report recommended for grant of new DML
based on inspection conducted on 09-10-2020 and 23-04-2021.
Remarks of the Evaluator X Oral Powder section (Veterinary) confirmed from panel
inspection report for grant of new DML based on inspection
conducted on 09-10-2020 and 23-04-2021.
Shortcomings:
Each gram contains:
Fructose 1,6 Diphosphate…180mg
Magnesium Phosphate…100mg
Sodium Chloride q.s.…1000mg
and fee of Rs. 30,000/- for correction/pre-approval change in formulation and finished product
557. Name and address of manufacturer / M/s Mili Vet Pharmaceuticals Pvt Ltd, Kamas Off 2Km,
Applicant Multalib Road, Near Sundar Industrial Estate, Raiwind Road,
Lahore.
Brand Name +Dosage Form + Mili Alben 10% Drench
Strength
Albendazole…100mg
(slip No. 890469735418)
Type of Form Form 5
Pack size & Demanded Price 50ml, 100ml, 250ml, 500ml and 1000ml: Decontrolled
Me-too status Albatop-10% Drench of M/s Wimits Pharmaceuticals, Lahore
(Reg. No. 078334)
GMP status Panel inspection report recommended for grant of new DML
based on inspection conducted on 09-10-2020 and 23-04-2021.
Remarks of the Evaluator X Oral Liquid section (Veterinary) confirmed from panel
inspection report for grant of new DML based on inspection
conducted on 09-10-2020 and 23-04-2021.
Decision: Approved.
558. Name and address of manufacturer / M/s Bio Labs Pvt Ltd., Plot # 145, Industrial Triangle, Kahuta
Applicant Road, Islamabad
Brand Name +Dosage Form + Predex Injection 10ml and 50ml
Strength
Prednisolone Acetate…7.5mg
Dexamethasone as Sodium Phosphate…2.5mg
(slip No. 09534344)
Pharmacological Group
Type of Form Form 5
Me-too status
GMP status cGMP certificate dated 28-02-2022 based on inspection dated
03-08-2021
 Approval of relevant manufacturing facility by the
Central Licensing Board.
 Revise Form-5 along with its enclosures since Predex
injection (Prednisolone Acetate…7.5mg/ml and
Dexamethasone as Sodium Phosphate…2.5mg/ml) is
mentioned on cover letter while Clarification regarding the
applied formulation and demanded pack size is required
 Separate registration is granted to separate pack size/fill
volume of injectable dosage form. However, both 50ml and
10ml pack sizes of injectable dosage form are demanded in
a single application. So clarification is required for which
pack size/ fill volume you want to apply this dossier.
already approved by DRAP (generic / me-too status)
alongwith registration number, brand name and name of
firm.
i. Me too Status.
ii. Confirmation of facility for Injecatble Steroids (Veterinary)
Brand Name +Dosage Form + Ceftin Injection 50ml
Strength
(slip No. 829114329)
Type of Form Form 5
Me-too status Excefur Injection (50ml) of M/s S.J. & G Fazul Ellahie (Pvt)
Limited., Karachi. (Reg. No. 063704)
03-08-2021
X
Decision: Deferred for confirmation of relevant manufacturing facility. The Board further decided
that the applicant shall submit the response within 1 month after publication of the minutes.
Brand Name +Dosage Form + Ceftin Injection 10ml
Strength
(slip No. 55279213)
Type of Form Form 5
03-08-2021
DRAP (generic / me-too status) with same pack size as
applied alongwith registration number, brand name and
name of firm.
 confirmation of relevant manufacturing facility
 evidence of applied formulation/drug already approved by DRAP (generic / me-too status) with
same pack size as applied alongwith registration number, brand name and name of firm.
publication of the minutes,
Brand Name +Dosage Form + Ectocide Injection 100ml
Strength
Deltamethrin…25mg
(slip No. 25327212506)
Pharmacological Group Insecticide
Type of Form Form 5
Me-too status Could not be confirmed in the applied dosage form and pack
size
03-08-2021
Remarks of the Evaluator X  Liquid Injection (General) section confirmed vide panel
inspection report based on inspection dated 08-07-2021, 15-
07-2021, 30-07-2021 and 03-08-2021 for renewal of DML.
Shortcomings:
name of firm.
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic /
me-too status) with same pack size as applied alongwith registration number, brand name and name
of firm. The Board further decided that the applicant shall submit the response within 1 month
after publication of the minutes, .
Brand Name +Dosage Form + Oxivet Oral Liquid
Strength
Oxolinic Acid…100mg
(slip No. 243308625)
Type of Form Form 5
Me-too status Eter Vet Liquid of M/s Eterna Pharma (Pvt) Ltd., Mirpur, AJK.
(Reg. No. 109229)
03-08-2021
Remarks of the Evaluator X  Oral Liquid section (General) (Veterinary) confirmed
vide panel inspection report based on inspection dated 08-
07-2021, 15-07-2021, 30-07-2021 and 03-08-2021 for
renewal of DML.
Decision: Approved. Fee of Rs. 7500/- for correction/pre-approval change in finished product
Brand Name +Dosage Form + Masti-Nil Oral Liquid
Strength
1Composition Each ml contains:
Calcium Chloride…8mg
Ammonium Chloride…50mg
Zinc Sulphate…0.025mg
Selenium…0.10mg
(slip No.89227140060)
Type of Form Form 5
03-08-2021
07-2021, 15-07-2021, 30-07-2021 and 03-08-2021 for
renewal of DML.
of testing facility (atomic absorption spectrophotometer).
Shortcomings:
Brand Name +Dosage Form + Formatic Acids Oral Liquid
Strength
Formic Acid…350mg
Propionic Acid…120mg
Citric Acid…10mg
Lactic Acid…5mg
Copper Sulphate…18mg
(slip No.74775391847)
Type of Form Form 5
Pack size & Demanded Price 500ml, 1000ml, 5000ml, and 30000ml: Decontrolled
03-08-2021
07-2021, 15-07-2021, 30-07-2021 and 03-08-2021 for
renewal of DML.
Shortcomings:
Brand Name +Dosage Form + Calciphos Oral Liquid
Strength
Phosphorus as Pentoxide…110mg
Calcium as Calcium Chloride…15mg
Sodium as Sodium Chloride…15mg
Magnesium as Magnesium Sulphate…22mg
Manganese as Manganese Sulphate…2.5mg
Zinc as Zinc Sulphate...2.2mg
Iron as Ferric Chloride...1.5mg
Copper Gluconate...0.49mg
(slip No.33254677097)
Type of Form Form 5
03-08-2021
 Oral Liquid section (General) (Veterinary) confirmed
07-2021, 15-07-2021, 30-07-2021 and 03-08-2021 for
renewal of DML.
Shortcomings:
Brand Name +Dosage Form + Calcimax Infusion 300ml
Strength
Calcium Gluconate…197.5mg
Calcium D Sachharate…10mg
Magnesium Hypophosphite…50mg
Magnesium Chloride…10mg
Boric Acid…42.5mg
Dextrose…200mg
(slip No. 83153839)
Type of Form Form 5
03-08-2021
Remarks of the Evaluator X  The firm has submitted list of equipments for confirmation
Shortcomings:
name of firm.
 Evidence of applied formulation/drug already approved by DRAP (generic / me-too status) with
Brand Name +Dosage Form + Mulitpro Injection
Strength
L-Carnitine…5mg
Thioctic Acid...0.20mg
Pyridoxine HCl...0.15mg
Cyanocobalamin...0.03mg
DL-Acetylmethionine...20mg
L-Arginine...2.40mg
L-Ornithine...1.20mg
L-Citruline...1.20mg
L-Lysine...0.50mg
Glycine...1.50mg
Taurine...1.50mg
Aspartic Acid...1.50mg
Glutamic Acid...1.50mg
Fructose...50mg
Sorbitol...80mg
& Rs.10,000/- dated 24-09-2021 (slip No. 4609565809)
Pharmacological Group Restorative
Type of Form Form 5
Pack size & Demanded Price 100ml, 250ml, 500ml: Decontrolled
Me-too status
03-08-2021
Remarks of the Evaluator X  The firm has submitted list of equipments for confirmation
of testing facility (HPLC).
Shortcomings:
volume of injectable dosage form. However, multiple pack
sizes of injectable dosage form are demanded in a single
application. So clarification is required for which pack size/
fill volume you want to apply this dossier
already approved by DRAP (generic / me-too status) with
same pack size as applied alongwith registration number,
brand name and name of firm.
 Choice of only one pack size
 Evidence of applied formulation/drug already approved by DRAP (generic / me-too status) with
Brand Name +Dosage Form + Megavit Injection 100ml
Strength
Sodium Selenate…0.5mg
Vitamin E…70mg
Vitamin B12…100mcg
Vitamin B1…20mg
Adenosine-5-Phosphoric Acid…5mg
Sorbitol…50mg
(slip No. 037467695)
Pharmacological Group Supplement
Type of Form Form 5
Me-too status Selevit Injectable Solution of M/s. Prix Pharma Lahore 023495
(composition and pack size could not be confirmed)
03-08-2021
Remarks of the Evaluator X Liquid Injection (General) section confirmed vide panel
inspection report based on inspection dated 08-07-2021, 15-07-
2021, 30-07-2021 and 03-08-2021 for renewal of DML.
Shortcomings:
name of firm.
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic /
me-too status) with same pack size as applied alongwith registration number, brand name and name
of firm. The Board further decided that the applicant shall submit the response within 1 month
after publication of the minutes, .
Brand Name +Dosage Form + Energizer Infusion 250ml
Strength
Caffeine…3.5mg
Sodium Salicylate…3.5mg
Novaminsulfon…40mg
Nicotinamide…0.3mg
Calcium Gluconate…100mg
Magnesium Gluconate…10mg
Boric Acid…10mg
Sorbitol…200mg
Soidum Alpha-Oxybenzylphosphonic Acid…5mg
Methyl Parahydroxybenzoate…0.7mg
(slip No. 22726082596)
Pharmacological Group Supplement
Type of Form Form 5
Me-too status
03-08-2021
Decision: Disposed off the instant application on the recommendation of the Expert Working Group
on Veterinary Drugs since veterinary drugs containing Novaminsulfon are associated with serious
adverse effects like agranulocytosis.
Brand Name +Dosage Form + Bromo Menthol Water Soluble Powder
Strength
Menthol…4mg
(slip No. 286992136234)
Pharmacological Group Mucolytic
Type of Form Form 5
Pack size & Demanded Price 100gm, 250gm, 500gm, 1000gm, 2500gm: Decontrolled
Me-too status Z-B Menthol Water Soluble Powder of M/s Zoic International,
03-08-2021
Brand Name +Dosage Form + Super Cool Water Soluble Powder
Strength
Vitamin C…200mg
Acetyl Salicylic Acid…67mg
Calcium Carbonate…50mg
Sodium Citrate…0.7mg
(slip No. 8424971818)
Pharmacological Group Antipyretic, Nutritional supplement
Type of Form Form 5
Pack size & Demanded Price 500gm, 1000gm, 2500gm: Decontrolled
Me-too status Coolant Powder of M/s Inshal Pharmaceutical Industries,
03-08-2021
Brand Name +Dosage Form + Neskep Oral Powder
Strength
Composition Each gm Contains:
Neomycin Sulphate…33.33mg
Streptomycin Sulphate…33.33mg
Sulfaguanidine…0.33gm
Kaolin…0.33gm
Pectin…33.33mg
Vitamin A Acetate…6666.67 IU
& Rs.10,000/- dated 24-09-2021 (slip No. 808816799)
Pharmacological Group Antibacterial, Antidiarrheal
Type of Form Form 5
Pack size & Demanded Price 100gm, 1000gm: Decontrolled
Me-too status Dyro-X Powder of M/s Selmore Pharmaceuticals (Pvt) Limited,
03-08-2021
X
Remarks of the Evaluator
Brand Name +Dosage Form + Para-Electro C Water Soluble Powder
Strength
Paracetamol…200mg
Vitamin C…50mg
Potassium Carbonate…125mg
Sodium Bicarbonate…125mg
Vitamin E…12.5mg
(slip No. 87676242855)
Pharmacological Group Antipyretic, Nutritional supplement
Type of Form Form 5
Pack size & Demanded Price 100gm, 250gm, 500gm, 1000gm: Decontrolled
Me-too status Peravit ST-20 Powder of M/s Vetec Laboratories,
03-08-2021
Brand Name +Dosage Form + Electro-C Water Soluble Powder
Strength
Paracetamol…20mg
Ascorbic Acid…200mg
Potassium Chloride…40mg
(slip No. 40561715804)
Pharmacological Group Antipyretic
Type of Form Form 5
Pack size & Demanded Price 100gm, 250gm, 500gm, 1000gm, 2500gm: Decontrolled
Me-too status Spin-C Powder of M/s Leads Pharma (Pvt) Ltd.,
03-08-2021
575. Name and address of manufacturer / M/s Nawan Laboratories (Pvt) Ltd., 136 sector 15 Korangi
Applicant Industrial Area Karachi.
Brand Name +Dosage Form + Zoster Oral Suspension
Strength
Oxfendazole…22.65mg
(slip No. 0943303893)
Type of Form Form 5
Me-too status Twozole Drench of M/s Selmore Pharmaceuticals (Pvt)
Limited, Lahore. (Reg. No. 099063)
concludes that firm was considered to be operating at good level
of overall GMP compliance
X
Remarks of the Evaluator Oral Liquid General Section confirmed from panel inspection
report conducted on 31-03-2022 for renewal of DML.
Brand Name +Dosage Form + Wormec DS Injection
Strength
Ivermectin…20mg
(slip No. 510178981)
Type of Form Form 5
Pack size & Demanded Price 10ml, 50ml: Decontrolled
Me-too status Ivermec 2% Injection (10ml; Reg. No. 111546) and (50ml; Reg.
No. 111547) of M/s Grand Pharma (Pvt) Ltd., Islamabad.
X
Remarks of the Evaluator Liquid Injection Vet Section confirmed from panel inspection
Shortcomings:
Decision: Approved. Firm shall select only one pack size before issuance of registration letter.
Brand Name +Dosage Form + Strox-34% Injection
Strength
Nitroxynil…340mg
(slip No. 22381961583)
Type of Form Form 5
Me-too status Nitroxl Forte Injection (10ml; Reg. No. 106697) and (50ml;
Reg. No. 106698) of M/s Mediexcel Pharmaceuticals,
Islamabad.
Remarks of the Evaluator X Liquid Injection Vet Section confirmed from panel inspection
Shortcomings:
 Fee of Rs. 7500/- for correction/pre-approval change in finished product specifications as per
notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021
 Choice of only one pack size.
Brand Name +Dosage Form + Astrowan Injection
Strength
Atropine Sulphate…1mg
(slip No. 4528170785)
Pharmacological Group Belladonna alkaloids, tertiary amine
Type of Form Form 5
Me-too status Atopin Injection (10ml, 25ml, 50ml and 100ml) of M/s Symans
Pharmaceuticals (Pvt) Ltd., Lahore (Reg. No. 062122)
Shortcomings:
100ml pack sizes of injectable dosage form are demanded
in a single application. So clarification is required for which
Brand Name +Dosage Form + Demotin Solution for Injection
Strength
Doramectin…10mg
(slip No. 7796447960)
Pharmacological Group Avermectin
Type of Form Form 5
Me-too status Dectron Liquid Injection (10ml; Reg. No. 087093) and (50ml;
Reg. No. 087095) of M/s ICI Pakistan Limited, Life Sciences,
Lahore.
X
Remarks of the Evaluator Liquid Injection Vet Section confirmed from panel inspection
Shortcomings:
Brand Name +Dosage Form + Metavit-Max Injection
Strength
Butaphosphan…100mg
Cyanocobalamin…50Mcg
Taurine…37.3mg
Nicotinamide…23mg
DL Methionine…18.7mg
(slip No. 48572491554)
Pharmacological Group Mineral supplements
Type of Form Form 5
Me-too status Fospho-AV Injection (50ml; Reg. No. 088084) and (100ml;
Reg. No. 099370) of M/s Selmore Pharmaceuticals (Pvt) Ltd.,
Lahore.
 Liquid Injection Vet Section confirmed from panel
inspection report conducted on 31-03-2022 for renewal of
DML.
of testing facility (FTIR nicolet 380)
Shortcomings:
100ml pack sizes of injectable dosage form are demanded
in a single application. So clarification is required for which
Brand Name +Dosage Form + Cefur DC Intramammary Suspension (10ml syringe)
Strength
(slip No. 443695010194)
Type of Form Form 5
Pack size & Demanded Price 12 x 10ml plastic syringes: Decontrolled
Me-too status Spectramast DC Sterile Suspension (10ml) of M/s Ghazi
Brothers, Karachi (Reg. No. 092190)
Remarks of the Evaluator X Approval of Liquid injection section (veterinary)
(Cephalosporin) confirmed vide letter No.F. 2-10/93-Lic
(Vol-I) dated 10-03-2022
Decision: Approved. Firm shall submit fee of Rs. 7500/- for correction/pre-approval change in
Brand Name +Dosage Form + Vivonex DC Intramammary Suspension
Strength
Rifaximin…20mg
(slip No. 35177194284)
Type of Form Form 5
Pack size & Demanded Price 12 x 5ml syringes: Decontrolled
Me-too status Fatroximin D.C Intramammary Ointment of M/s Prix
Pharmaceutica, Lahore. (Reg. No. 095647)
583. Name and address of manufacturer / M/s Majestic Pharma, Plot No. 21, Phase No.1-A, M-3
Applicant Industrial City, Sahianwala, Faisalabad
Brand Name +Dosage Form + Floroxy-M Forte Oral Powder
Strength
Florfenicol…300mg
(slip No.7173519642)
Type of Form Form-5
Pack size & Demanded Price 100gm, 250gm, 500gm, 1000gm, and 5000gm; Decontrolled
Me-too status Ampronil-50 Oral Powder of M/s Westmont Pharmaceutical
Industry, Gujar Khan, Distt. Rawalpindi (Reg. No. 063747)
GMP status Last GMP inspection conducted on 07-03-2023 concludes that
firm was considered to be operating at satisfactory level of GMP
compliance.
Remarks of the Evaluator X Oral powder (General) section confirmed vide letter No. F.1-
10/2015-Lic dated 26-12-2017
Brand Name +Dosage Form + Lincomag Oral Powder
Strength
(slip No.449529034097)
Type of Form Form-5
Pack size & Demanded Price 100gm, 500gm, 1000gm, 5000gm, 10000gm and 25000gm;
Decontrolled
Me-too status Lincobar-44 Powder of M/s Baariq Pharmaceuticals,
compliance.
10/2015-Lic dated 26-12-2017
Brand Name +Dosage Form + Linconex-100 Oral W/S Powder
Strength
Colistin Sulphate…800,000 IU
(slip No.84600497358)
Type of Form Form-5
Decontrolled
Me-too status Z-Lincolis Water Soluble Powder of M/s Zoic International,
compliance.
X
Remarks of the Evaluator Oral powder (General) section confirmed vide letter No. F.1-
10/2015-Lic dated 26-12-2017
Brand Name +Dosage Form + Phosfomax-M Oral Powder
Strength
Fructose…180mg
(slip No.3733087015)
Type of Form Form-5
Me-too status Fosomax Oral Powder of M/s Biogen Pharma, Rawat (Reg. No.
063808)
compliance.
10/2015-Lic dated 26-12-2017
Shortcomings:
Each gram contains:
Firm shall submit fee of Rs.30000/- for correction/pre-approval change in formulation (salt form)
and finished product specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-
2021 before issuance of registration letter.
Brand Name +Dosage Form + Maji Ampicox 30 Oral W/S Powder
Strength
Sulphaquinoxaline Sodium…200mg
Vitamin K3…6mg
(slip No.6937473165)
Pharmacological Group Anticoccidal
Type of Form Form-5
Me-too status Amral-SK Powder of M/s Elegance Pharmaceuticals, Distt.
compliance.
10/2015-Lic dated 26-12-2017
Decision: Deferred for solubility of formulation. The Board further decided that the applicant shall
submit the response within 1 month after publication of the minutes.
Brand Name +Dosage Form + Le-Mune Oral Powder
Strength
Lysozyme…220mg
Vitamin E 50 SD…5mg
(slip No.340303522)
Pharmacological Group Immunostimulator/Antimicrobial
Type of Form Form-5
Decontrolled
Me-too status Hylise Water Soluble Powder of M/s Mylab (Pvt) Ltd,
Bahawalpur. (Reg. No. 112256)
compliance.
10/2015-Lic dated 26-12-2017
Brand Name +Dosage Form + Urinoflush Oral W/S Powder
Strength
Frusemide…20mg
Maganese Sulphate…1mg
Potassium Chloride…0.400mg
(slip No.107084953151)
Pharmacological Group Combination of minerals and diuretic
Type of Form Form-5
Pack size & Demanded Price 500gm, 1000gm, and 5000gm; Decontrolled
Me-too status Neyphralyte Powder of M/s Selmore Pharmaceutical (Pvt) Ltd.,
compliance.
10/2015-Lic dated 26-12-2017
Decision: Approved. The firm shall submit fee of Rs. 30,000/- for correction in formulation (salt
form of furosemide) and change in finished product specifications, as per notification No.F.7-
11/2012-B&A/DRAP dated07-05-2021 before issuance of registration letter.
Applicant Industrial City, Sahianwala Faisalabad
Brand Name +Dosage Form + M-Flox BC Oral Liquid
Strength
(slip No.3945112648)
Type of Form Form-5
Pack size & Demanded Price 100ml, 250ml, 500ml, 1000ml, 2500ml, and 5000ml;
Decontrolled
Me-too status EG Supertonic Solution of M/s Evergreen Pharmaceuticals,
compliance.
X
Remarks of the Evaluator Oral liquid (General) section confirmed vide letter No. F.1-
10/2015-Lic dated 26-12-2017
Brand Name +Dosage Form + AG Flox-M Oral Liquid
Strength
Aminophylline…40mg
Guaiphenesin…100mg
(slip No.46822541559)
Pharmacological Group Antibacterial, expectorant
Type of Form Form-5
Pack size & Demanded Price 100ml, 250ml, 500ml, 1000ml, and 5000ml; Decontrolled
Me-too status Amino GE 2400 Oral Liquid of M/s Kayans Pharmaceuticals,
compliance.
Remarks of the Evaluator X Oral liquid (General) section confirmed vide letter No. F.1-
10/2015-Lic dated 26-12-2017
Brand Name +Dosage Form + M-Brom Plus Oral Solution
Strength
(slip No.505257971686)
Type of Form Form-5
Pack size & Demanded Price 100ml, 200ml, 500ml, 1000ml, 2500ml and 5000ml;
Decontrolled
Me-too status Bromit 5% Oral Solution of M/s Wimits Pharmaceuticals,
Lahore. (Reg. No.112386)
compliance.
X
Remarks of the Evaluator Oral liquid (General) section confirmed vide letter No. F.1-
10/2015-Lic dated 26-12-2017
Brand Name +Dosage Form + Normin-AG Oral Liquid
Strength
Norfloxacin…200mg
Aminophylline…80mg
Guaifenesin…200mg
(slip No.98562844748)
Pharmacological Group Antibacterial, expectorant
Type of Form Form-5
Me-too status NOR + AG Solution of M/s Biogen Pharma Rawat (Reg. No.
058968)
compliance.
10/2015-Lic dated 26-12-2017
Decision: Disposed off the instant application on the recommendation of Expert Working Group on
Veterinary Drugs due to potential of AMR and in the best public health interest.
Brand Name +Dosage Form + Majizaan Drench
Strength
Oxyclozanide…60mg
Levamisole HCl…30mg
(slip No.21545535451)
Type of Form Form-5
Pack size & Demanded Price 100ml, 250ml, 450ml, and 1000ml; Decontrolled
Me-too status Nawazan DS Suspension of M/s Nawan Laboratories (Pvt.)
Ltd, Karachi. (Reg. No. 101445)
compliance.
10/2015-Lic dated 26-12-2017
Brand Name +Dosage Form + Majitone Oral Suspension
Strength
Silymarin…21mg
Vitamin E…15mg
(slip No.861675734)
Pharmacological Group Hepatoprotective, Antioxidant
Type of Form Form-5
Me-too status Liver Fit Oral Suspension of M/s Westmont Pharmaceutical
Industry, Distt. Rawalpindi (Reg. No. 063743)

compliance.
10/2015-Lic dated 26-12-2017
Decision: Approved.
Brand Name +Dosage Form + Majizole Drench
Strength
Albendazole…100mg
(slip No.16689462636)
Type of Form Form-5
Pack size & Demanded Price 100ml, 150ml, 500ml, and 1000ml; Decontrolled
Me-too status Bendol 10 Suspension of M/s Eterna Pharma (Pvt) Ltd.,
Mirpur, AJK. (Reg. No. 113512)
compliance.
10/2015-Lic dated 26-12-2017
Brand Name +Dosage Form + E-Sel Grow Oral Liquid
Strength
Vitamin C…40mg
Vitamin E…200mg
Selenium as Sodium Selenite…25mg
(slip No.3215668345)
Pharmacological Group Vitamin and mineral
Type of Form Form 5
Pack size & Demanded Price 100ml, 500ml and 1000ml; Decontrolled
Me-too status Soluvit E Plus Liquid of M/s Leads Pharma (Pvt) Ltd
 Veterinary Oral Liquid (General) section confirmed vide
letter No. F.1-41/2007-Lic (Vol-I) dated 18-03-2021
of testing facility.
Shortcomings:
along with fee Rs. 30,000/- for change of title of the firm.
Decision: Approved.
Brand Name +Dosage Form + Noxin Oral Solution
Strength
Norfloxacin HCl…200mg
(slip No.606605462)
Type of Form Form 5
Pack size & Demanded Price 100ml, 500ml and 1000ml; Decontrolled
Me-too status Nor-Oxime Oral Liquid of M/s Bio-Oxime Pharmaceuticals,
Faisalabad (Reg. No. 080137)
Remarks of the Evaluator X Veterinary Oral Liquid (General) section confirmed vide
letter No. F.1-41/2007-Lic (Vol-I) dated 18-03-2021
Shortcomings:
along with fee Rs. 30,000/- for change of title of the firm.
Decision: Disposed off the instant application on the recommendation of Expert Working Group on
Veterinary Drugs due to potential of AMR and in the best public health interest.
Brand Name +Dosage Form + Tylofosfin Oral Powder
Strength
Calcium Fosfomycin…200mg
Fructose…180mg
(slip No.854280656)
Pharmacological Group Antibiotic/ Mineral
Type of Form Form 5
Pack size & Demanded Price 500gm, 1000gm, 5000gm, and 25000gm; Decontrolled
Me-too status FAS-FO 73 Powder of M/s Eterna Pharma (Pvt) Ltd.,
Mirpur, AJK (Reg. No. 113592)
Remarks of the Evaluator X Oral Dry Powder (General) Veterinary section confirmed
vide letter No. F.1-41/2007-Lic (Vol-I) dated 18-03-2021
Shortcomings:
along with fee Rs. 30,000/- (slip No. 96708637494) for
 Correction in formulation (salt form) in line with reference
formulation is required.
Each gram contains:
Fosfomycin Calcium …200mg
Brand Name +Dosage Form + Vita-Poul Oral Powder
Strength
Vitamin D3…2000 IU
Vitamin E…6mg
Vitamin K3…5mg
(slip No.46579541912)
Pharmacological Group Vitamins
Type of Form Form 5
Pack size & Demanded Price 500gm, 1000gm, 5000gm, and 25000gm; Decontrolled
Me-too status Kaaz-ADEK Powder of M/s English Pharma, Lahore (Reg.
No. 028510)
Remarks of the Evaluator X Oral Dry Powder (General) Veterinary section confirmed
vide letter No. F.1-41/2007-Lic (Vol-I) dated 18-03-2021
Shortcomings:
along with fee Rs. 30,000/- (slip No. 2858070878) for
Decision: Approved.
601. Name and address of manufacturer / M/s Noble Pharma, Plot No. B-1 Old Industrial Area,
Applicant Mirpur, Azad Kashmir
Brand Name +Dosage Form + Nobi Oxfn Powder
Strength
Florfenicol…100mg
(slip No.967088793554)
Type of Form Form 5
Finished product Specification Inhouse specifications
Pack size & Demanded Price 100gm,250gm, 500gm, 1000gm; Decontrolled
Me-too status Stonis Powder of M/s Nawal Pharmaceuticals, Taxila. (Reg.
No. 097977)
GMP status Panel inspection of M/s Noble Pharma, Azad Kashmir has been
carried out on 09-02-2022. It was observed to do a lot of
improvements in HVAC, Pharmaceutical Quality systems
including documentation and other quality related areas.
The firm submitted improvements in these areas. A detailed
report would be submitted later on after verification of same
through onsite inspection.
Remarks of the Evaluator X  Veterinary Oral Powder (General) section confirmed vide
letter No.F. 5-2/2007-Lic dated 08-07-2015
Shortcomings:
 Latest GMP inspection report conducted within the period of
last three years.
Brand Name +Dosage Form + Nobi Ksulp Powder
Strength
Sulphachlorpyridazine Sodium…333.3mg
Vitamin K3…30mg
(slip No.72549656)
Type of Form Form 5
Pack size & Demanded Price 100gm,250gm, 500gm, 1000gm; Decontrolled
Remarks of the Evaluator X  Veterinary Oral Powder (General) section confirmed
vide letter No.F. 5-2/2007-Lic dated 08-07-2015
Shortcomings:
Brand Name +Dosage Form + Nobifos-Forte Oral Powder
Strength
Fructose…180mg
Sodium Chloride QS…1000mg
(slip No.694663696876)
Type of Form Form 5
Pack size & Demanded Price 100gm, 500gm, 1000gm; Decontrolled
Me-too status Fosbac Plus-T Powder of M/s Tec-Man International,
Shortcomings:
Each gram contains:
Sodium Chloride QS…1000mg
alongwith fee of Rs.30000/- for correction/pre-approval change in formulation (salt form) and
Brand Name +Dosage Form + Nobificoc Powder
Strength
Sulphadimerazine…100mg
Sulphadiazine…60mg
Sulphathiazole…40mg
Trimethoprim…40mg
(slip No.1611471729)
Type of Form Form 5
Pack size & Demanded Price 100gm, 500gm, 1000gm; Decontrolled
Me-too status TS-30 Powder of M/s Elegance Pharmaceuticals, Rawalpindi.
(Reg. No. 074002)
Shortcomings:
Brand Name +Dosage Form + Nobixol Liquid
Strength
Oxolinic Acid…100mg
(slip No. 24464208128)
Type of Form Form 5
Me-too status Eter Vet Liquid of M/s Eterna Pharma (Pvt) Ltd., Mirpur,
AJK. (Reg. No. 109229)
Remarks of the Evaluator X Approval of Veterinary Oral Liquid (General) section
confirmed vide letter No.F. 5-2/2007-Lic dated 08-07-2015.
Shortcomings:
Latest GMP inspection report conducted within the period
606. Name and address of manufacturer / M/s Izfaar Pharmaceutical Pvt. Ltd., 542-A & B, Sundar
Applicant Industrial Estate, Lahore.
Brand Name +Dosage Form + Meprafar Injection
Strength
Mepyramine Maleate…50mg
(slip No. 676552239431)
Pharmacological Group Antihistamine/ Anti-allergic
Type of Form Form 5
Pack size & Demanded Price 10ml, 30ml; Decontrolled
Me-too status Elramine Injection (10ml, 30ml) of M/s Elko Organisation
(Pvt) Ltd Karachi (Reg. No. 018458)
GMP status
Remarks of the Evaluator X Veterinary Liquid Injection (General) section confirmed vide
letter No.F. 1-29/2007-Lic (M-236) dated 23-09-2014.
Shortcomings:
 Title of the firm mentioned on DML is “M/s Izfaar
Pharmaceutical Industries” while “M/s Izfaar
Pharmaceutical Pvt. Ltd.” is mentioned on form-5 and fee
challan; clarify.
 Clarification regarding title of the firm since on DML “M/s Izfaar Pharmaceutical Industries”
while “M/s Izfaar Pharmaceutical Pvt. Ltd.” is mentioned on form-5 and fee challan.
607. Name and address of manufacturer / M/s Izfaar Pharmaceutical Pvt. Ltd., 542-A & B, Sundar
Applicant Industrial Estate, Lahore.
Brand Name +Dosage Form + Maxofar Injection
Strength
(slip No. 72927892)
Pharmacological Group Antipyretic/ Anti-inflammatory
Type of Form Form 5
Pack size & Demanded Price 10ml, 20ml, 50ml; Decontrolled
Me-too status Fluxim-5% Injection (10ml: Reg. No. 109941; 20ml:109942;
and 50ml: 109943) of M/s Univet Pharmaceuticals,
Rawalpindi.
GMP status
Shortcomings:
volume of injectable dosage form. However, multiple pack
sizes of injectable dosage form are demanded in a single
application. So clarification is required for which pack size/
fill volume you want to apply this dossier.
 Title of the firm mentioned on DML is “M/s Izfaar
Pharmaceutical Industries” while “M/s Izfaar
Pharmaceutical Pvt. Ltd.” is mentioned on form-5 and fee
challan; clarify.
 Revised form-5 along with fee of Rs.30000/- for correction in formulation (salt form) in line with
reference product, as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021
 Clarification regarding title of the firm since on DML “M/s Izfaar Pharmaceutical Industries”
while “M/s Izfaar Pharmaceutical Pvt. Ltd.” is mentioned on form-5 and fee challan.
608. Name and address of manufacturer / M/s Izfaar Pharmaceutical Industries, 542-A, Sundar Industrial
Applicant Estate, Lahore.
Brand Name +Dosage Form + Sulfa-Far Injection 100ml
Strength
Sulphadimidine Sodium…333mg
(slip No. 45299206)
Type of Form Form 5
Me-too status Sulpharas Injection (100ml) of M/s RAS Pharmaceuticals
(Pvt) Ltd., Multan. (Reg. No. 109954)
GMP status
Shortcomings:
 Address of the firm mentioned on DML is “542/A-B,
Sundar Industrial Estate, Lahore” while “542-A, Sundar
Industrial Estate, Lahore” is mentioned on form-5.
Moreover, title of the firm mentioned on DML and form-5
is “M/s Izfaar Pharmaceutical Industries” while “M/s
Izfaar Pharmaceutical Pvt. Ltd.” is mentioned on fee
challan; clarify.
 Clarification regarding title and address of the firm since address of the firm mentioned on
DML is “542/A-B, Sundar Industrial Estate, Lahore” while “542-A, Sundar Industrial Estate,
Lahore” is mentioned on form-5. Moreover, title of the firm mentioned on DML and form-5 is
“M/s Izfaar Pharmaceutical Industries” while “M/s Izfaar Pharmaceutical Pvt. Ltd.” is mentioned
on fee challan.
609. Name and address of manufacturer / M/s Selmore Pharmaceuticals Pvt Ltd., 36-Km, Multan Road
Applicant Lahore.
Brand Name +Dosage Form + Trioxysol Oral Powder
Strength
Florfenicol…100mg
(slip No. 29990313691)
Pharmacological Group Antibiotic combination
Type of Form Form 5
Pack size & Demanded Price 100gm, 1000gm, 2500gm, 5000gm: Decontrolled
Me-too status Stenop Powder of M/s Majestic Pharma, Faisalabad.
(Reg. No. 089846)
24-01-2023 & 25-01-2023
Remarks of the Evaluator X Oral Powder (General) Veterinary section confirmed vide
cGMP certificate based upon evaluation conducted on 24-01-
2023 and 25-01-2023
Decision: Approved.
610. Name and address of manufacturer / M/s Star Laboratories Pvt Ltd., 23-km, Multan Road, Lahore.
Applicant
Brand Name +Dosage Form + Amino-Vita 250ml Injection
Strength
L-Carnitine HCl 6.133mg Eq. to L-Carnitine…5mg
Thioctic Acid...0.20mg
Cyanocobalamin...0.03mg
D L-Acetylmethionine...20mg
L-Arginine...2.40mg
L-Ornithine HCl 1.532mg Eq. to L-Ornithine...1.20mg
L-Citrulline...1.20mg
L-Lysine HCl 0.625mg Eq. to L-Lysine...0.50mg
Glycine...1.50mg
Taurine...1.50mg
Aspartic Acid...1.50mg
Glutamic Acid...1.50mg
Fructose...50mg
Sorbitol...80mg
(slip No. 12207413635)
Pharmacological Group Vitamins & other micronutrients
Type of Form Form 5
Pack size & Demanded Price 250ml vial; Decontrolled
Me-too status Multimino-V Injection (250ml) of M/s Selmore
Pharmaceuticals (Pvt) Ltd., Lahore (Reg. No. 058712)
Remarks of the Evaluator X  Liquid injectable (veterinary) section confirmed vide
panel inspection dated 14-12-2015 report for renewal of
DML.
of testing facility.
Shortcomings:
Liquid injectable LVP (veterinary)
that the applicant shall submit the response within 1 month after publication of the minutes, .
Applicant Road, Islamabad.
Brand Name +Dosage Form + Pregnasure Injection 2.5ml
Strength
Buserelin Acetate…0.004mg
(slip No. 5663217879)
Pharmacological Group LHRH agonist
Type of Form Form 5
Pack size & Demanded Price 2.5ml; Decontrolled
Me-too status Buserovet Injection (2.5ml) of M/s Vetz Pharmaceuticals
03-08-2021
 Approval of Veterinary Liquid vials injection
(Hormone) section/manufacturing facility by the Central
Licensing Board. However, you may submit panel
inspection report for renewal of DML verifying the
section/manufacturing facility.
 The firm shall submit fee of Rs. 30,000/- for correction/pre-
approval change in label claim in line with reference
formulation, finished product specifications and
typographic error in brand and generic name on cover letter
as per notification No.F.7-11/2012-B&A/DRAP dated 07-
05-2021 before issuance of registration letter.
 confirmation of relevant manufacturing facility.
 fee of Rs. 30,000/- for correction/pre-approval change in label claim in line with reference
formulation, finished product specifications and typographic error in brand and generic name
on cover letter as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021
Applicant Road, Islamabad.
Brand Name +Dosage Form + Pregtin Injection 10ml
Strength
Progesterone…25mg
(slip No. 7249572276)
Pharmacological Group Steroid
Type of Form Form 5
Me-too status I-Proges Injection (10ml) of M/s International Pharma Labs.
03-08-2021
 Approval of Veterinary Liquid vials injection
(Hormone) section/manufacturing facility by the Central
Licensing Board. However, you may submit panel
inspection report for renewal of DML verifying the
section/manufacturing facility.
that the applicant shall submit the response within 1 month after publication of the minutes, .
b. Deferred Cases
613. Name and address of manufacturer / M/s D-Maarson Pharmaceuticals, Plot No. 17, St SS-2,
Applicant National Industrial Zone, Rawat, Islamabad.
Brand Name +Dosage Form + Ivoran Plus Injection 10ml
Strength
Ivermectin…1gm
Vitamin D3…3,75,000 IU
Vitamin E…2.5gm
Diary No. Date of R& I & fee Dy.No 24955 dated 25-11-2019 Rs.20,000/- dated 25-11-
2019
Pharmacological Group Anthelmintic/ Multivitamins
Type of Form Form 5
Mectin Plus Injection (10ml) of M/s Breeze Pharma
Me-too status
GMP status
Remarks of the Evaluator X  Approval of section/manufacturing facility by the
 Provide conversion of Vitamin A and vitamin D3 from
IU to grams.
Decision of 324th meeting: Deferred for submission of evidence of approval of required
manufacturing facility i.e., Liquid Injection (Veterinary) section from CLB or else while firm may
transfer the registration application to by way of contract manufacturing upon submission of new
Form-5, within six months.
Updated status: Liquid Vial Injectable General (Veterinary) section confirmed vide letter No. F.
6-3/2014-Lic (M-234) dated 24-03-2014.
Decision: Approved. The firm shall submit the following before issuance of registration letter:
 conversion of Vitamin A and vitamin D3 from IU to grams.
 fee of Rs. 7500/- for correction/pre-approval change in finished product specifications as
per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
614. Name and address of manufacturer / M/s D-Maarson Pharmaceuticals, Plot No. 17, St SS-2,
Applicant National Industrial Zone, Rawat, Islamabad.
Brand Name +Dosage Form + Ivoran Plus Injection 50ml
Strength
Ivermectin…1gm
Vitamin D3…3,75,000 IU
Vitamin E…2.5gm
2019
Pharmacological Group Anthelmintic/ Multivitamins
Type of Form Form 5
Mectin Plus Injection (50ml) of M/s Breeze Pharma
Me-too status
GMP status
Remarks of the Evaluator X  Approval of section/manufacturing facility by the
 Provide conversion of Vitamin A and vitamin D3 from
IU to grams.
th
Decision of 324 meeting: Deferred for submission of evidence of approval of required
Form-5, within six months.
Updated status: Liquid Vial Injectable General (Veterinary) section confirmed vide letter No. F.
6-3/2014-Lic (M-234) dated 24-03-2014.
Decision: Approved. The firm shall submit the following before issuance of registration letter:
 conversion of Vitamin A and vitamin D3 from IU to grams.
 fee of Rs. 7500/- for correction/pre-approval change in finished product specifications as
615. Name and address of manufacturer / M/s Athan Pharmaceuticals, Plot 84/1, Block B, Phase V,
Applicant Industrial Estate, Hattar.
Brand Name +Dosage Form + Albofyl D Oral Solution
Strength
Enrofloxacin…10gm
Colistin Sulphate…55MIU
Bromhexine HCl…0.5mg
Diary No. Date of R& I & fee Dy. No 33143 dated 18-11-2022 Rs. 30,000/- dated 31-10-
2022
Type of Form Form 5
Finished product Specification Innovator‘s specifications
Pack size & Demanded Price 100ml, 300ml, 500ml, 1000ml: Decontrolled
GMP status Oral Syrup (General-Veterinary) section granted vide
letter No. F. 1-16/2013-Lic. dated 08-11-2022
Remarks of the Evaluator X  The firm has submitted that Colistin sulphate
19MIU=1gm
Shortcomings:
by DRAP (generic / me-too status) alongwith
Decision of 323rd meeting: Deferred for evidence of applied formulation/drug already approved by
DRAP (generic / me-too status) alongwith registration number, brand name and name of firm.
Updated status: The firm has now revised the formulation as mentioned below:
Each 100ml Contains:
Enrofloxacin…10gm
Bromhexine HCl…0.5gm
 Metoo status:
En-C Raft Oral Liquid of M/s Nawal Pharmaceuticals, Rawalpindi. (Reg. No. 078251)
The firm has submitted fee Rs. 30,000/- for revision of label claim via deposit slip no 405866381230
Each 100ml Contains:
Enrofloxacin…10gm
Bromhexine HCl…0.5gm
616. Name and address of manufacturer / M/s Baariq Pharmaceuticals, Plot # 600, Sundar Industrial
Applicant Estate, Sundar Raiwind Road, Lahore
Brand Name +Dosage Form + Toldibar Injection
Strength
Toldimfos Sodium…20gm
Vitamin B-12…5mg
2019
Pharmacological Group Vitamin
Type of Form Form 5
Tonovit Injetion (50ml) of M/s Selmore Pharmaceuticals
Me-too status
(Pvt) Ltd, Lahore. (Reg. No. 033253)
GMP status
Remarks of the Evaluator X  Latest GMP inspection report (conducted within the
Form 5, within six months.
Updated status: Liquid Injection (General) Veterinary section confirmed vide letter No. F. 1-
11/2010-Lic (Vol-I) dated 14-09-2017.
617. Name and address of manufacturer / M/s Intervac Pvt. Limited, 18-Km, Lahore Sheikhupura
Applicant Road, Sheikhupura, Pakistan
Brand Name +Dosage Form + Sulfa-L Bolus
Strength
Composition Each Bolus Contains:
Sulphadimidine…350mg
2020
Type of Form Form 5
Pack size & Demanded Price 50s: Decontrolled
GMP status cGMP Inspection conducted on 08-10-2020 concluded
Remarks of the Evaluator X  Bolus section confirmed from panel inspection report
for renewal of DML based on inspection conducted on
28-05-2019 and 19-06-2019
Shortcomings:
 Clarification of salt form
 Clarification of salt form
Each Bolus Contains:
Sulphadimidine HCl…350mg
 Metoo status:
Sulf-B Bolus of M/s International Pharma Labs. Lahore. (Reg. No. 073930)
The firm has Not submitted fee Rs. 30,000/- for revision of label claim.
Decision: Approved. Firm shall submit fee Rs. 30,000/- for correction/pre-approval change in
label claim in line with reference formulation and finished product specifications as per
notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021 before issuance of registration
letter.
618. Name and address of manufacturer / M/s Epoch Pharmaceuticals, Plot # 83-85, Sector 15, Korangi
Applicant Industrial Area, Karachi.
Brand Name +Dosage Form + Ketolin Injection Vet I/M, S/C
Strength
Composition Each ml injection contains:
Oxytetracycline as HCl…….200mg
Ketoprofen………………30mg
Diary No. Date of R& I & fee Dy.No.3474 dated 22-01-2019; Rs.20,000/- Dated 22-01-
2019
Pharmacological Group Anti- infective/ NSAIDs
Type of Form Form- 5
Finished product Specification Manufacturers
Pack size & Demanded Price 10ml, 100ml & Decontrolled
Keto- Oxy La Injection M/s International Pharma Labs,
Me-too status
Defence Road, Lahore 094412
GMP status Last GMP inspection was conducted on 28-09-2020
And the report concludes:
“In compliance to decision of 276th meeting of CLB,
contravention of the Drugs Act, 1976 rules made there
under, non-compliance of GMP conditions and non-
compliance of conditions of the Drug Manufacturing
License, you are hereby ordered to Show Cause Notice in
writing as to why the following proceeding may not be
initiated against you.
a) Cancellation/Suspension of DML of Liquid
Injectable/Sterile area.
b) Prosecution in the Drug Court.
c) Any other action taken by the concerned Board.
Remarks of the Evaluator  GMP status is not compliant.
Decision of 297th meeting: Deferred for updated status of GMP of the firm from QA & LT division
as inspection report submitted by firm does not conclude GMP compliant status
Updated status: The firm has submitted cGMP certificate dated 20-12-2022 based on inspection
Decision: Referred to EWG on veterinary drugs to review therapeutic requirement keeping in
view safety, efficacy and quality parameters.
619. Name and address of manufacturer / M/s Epoch Pharmaceuticals, Plot # 83-85, Sector 15,
Applicant Korangi Industrial Area, Karachi
Brand Name +Dosage Form + Trimisole Suspension
Strength
Composition Each ml Suspension Contains:
Triclabendazole……………120mg
Levamisole HCl……………75mg
Diary No. Date of R& I & fee Form-5 Dy.No 11417 dated 05-03-2019 Rs.20,000/- 05-
03-2019
Type of Form Form 5
Pack size & Demanded Price 100ml, 1000ml; Decontrolled
Flukazole Suspension 19.5% by M/s S.J. & G. Fazul Ellahie
Me-too status
(Reg#048297)
GMP status The firm was inspected on 28-09-2020 and conclusion of
inspection was:
In compliance to decision of 276th meeting of CLB,
contravention of the Drugs Act, 1976 rules made there
under, non-compliance of GMP conditions and non-
compliance of conditions of the Drug Manufacturing
License, you are hereby ordered to Show Cause Notice in
writing as to why the following proceeding may not be
initiated against you.
a) Cancellation/Suspension of DML of Liquid
Injectable/ Sterile area.
b) Prosecution in the Drug Court.
c) Any other action taken by the concerned Board
Remarks of the Evaluator  The firm submitted letter No. F. 2-1/94-Lic (Vol. I) dated
14th September 2006 issued by Secretary Central
Licensing Board confirming the presence of Veterinary
oral. However, it does not confirm whether it is oral liquid
or oral powder
 The firm submitted complete manufacturing outline
 Updated status of GMP of the firm from QA & LT division
 Evidence of required manufacturing facility / section from licensing division
Updated status: The firm has submitted the following:
 cGMP certificate dated 20-12-2022 based on inspection conducted on 21-11-2022
 Oral liquid (General) Veterinary section confirmed vide letter No. F. 2-1/94-Lic (Vol-III)
dated 10-06-2022
Decision: Approved. The firm shall submit fee Rs. 7500/- for correction/pre-approval change
in finished product specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-
620. Name and address of manufacturer / M/s Decent Pharma, Plot No. 30, Street SS-3, National
Applicant Industrial Zone, Rawat, Islamabad.
Brand Name +Dosage Form + Clomectin Pour on Liquid
Strength
Ivermectin…5mg
Closental as Sodium…200mg
2020
Pharmacological Group Endectocide (Anthelmintic and ectoparasitic)
Type of Form Form 5
100ml, 200ml, 450ml, 500ml, 1Liter, 2.5Liter, 5Liter,
Pack size & Demanded Price
10Liter, 20Liter: Decontrolled
Could not be confirmed in the applied strength and dosage
Me-too status
form
 Evidence of approval of Topical Liquid (General)
section.
th
Decision of 324 meeting: Registration Board was apprised that the letter of shortcoming has been
initially issued to the firm, hence Board deferred the case for submission of reply to the above cited
shortcomings within six months.
Updated status: The firm has now revised the brand name and formulation as mentioned below:
Clomectin Oral Liquid

Each ml Contains:
Ivermectin…10mg
Demanded pack sizes: 50ml, 100ml, 200ml, 450ml, 500ml, 1000ml, 2500ml, 5000ml, 10000ml,
20000ml
 Metoo status:
Iver-Par Oral Liquid of M/s Grand Pharma (Pvt) Ltd., Islamabad. (Reg. No.062036)
 The firm has submitted fee Rs. 30,000/- vide challan No. 35250379958 for revision of label
claim.
 Oral Liquid (General) section confirmed vide panel inspection dated 10-03-2022, 21-04-
2022 and 09-05-2022 report for approval of DML renewal
Decision: Approved with change in brand name, as per innovator’s specifications and with
following label claim:
Clomectin Oral Liquid
Each ml Contains:
Ivermectin…10mg
Brand Name +Dosage Form + Clomisol Injection
Strength
Levamisol as HCl…100mg
Closental Sodium Di-Hydrate…5mg
2020
Type of Form Form 5
Pack size & Demanded Price 10ml, 20ml, 50ml, 100ml, 450ml, 500ml: Decontrolled
Me-too status
Remarks of the Evaluator X  Liquid injectable (General) section confirmed vide
panel inspection dated 10-03-2022, 21-04-2022 and 09-
05-2022 report for approval of DML renewal
volume of injectable dosage form. However, multiple
pack sizes of injectable dosage form are demanded in a
single application. So clarification is required for which
by DRAP (generic / me-too status) with same fill
volume/ pack size as applied, alongwith registration
Decision of 324th meeting: Deferred for evidence of applied formulation/drug already approved by
DRAP (generic / me-too status) with same fill volume/ pack size as applied, alongwith registration
Each ml Contains:
Levamisol as base…100mg
Closental …50mg
Demanded pack size: 100ml
Metoo status:
Closole Injection (100ml) of M/s Attabak Pharmaceuticals, Islamabad. (Reg. No.062158)
 The firm has NOT submitted fee Rs. 30,000/- for revision of label claim.
Decision: Approved with 100ml pack size, as per innovator’s specifications and with following
label claim:
Each ml contains:
Levamisol as base…100mg
Closental …50mg
Firm shall submit fee Rs. 30,000/- for correction/pre-approval change in label claim in line with
reference formulation and finished product specifications as per notification No.F.7-11/2012-
B&A/DRAP dated 07-05-2021 before issuance of registration letter.
Brand Name +Dosage Form + Butavit Injection
Strength
Butaphosphan…100mg
Cyanocobalamin…50mcg
2019
Pharmacological Group Phosphorus supplement/ Viatmin
Type of Form Form 5
Carosil Injectable Solution (100ml) of M/s Huzaifa
Me-too status International, Sargodha. (Reg. No. 074046) Could not be
confirmed in the applied fill volume/ pack size
 Liquid injectable (General) section confirmed vide
panel inspection dated 10-03-2022, 21-04-2022 and 09-
05-2022 report for approval of DML renewal.
Shortcoming:
by DRAP (generic / me-too status) with the applied fill
volume/pack size alongwith registration number, brand
name and name of firm.
Decision of 324th meeting: Registration Board was apprised that the letter of shortcoming has been
initially issued to the firm, hence Board deferred the case for submission of reply to the above cited
Updated status: The firm has now revised the demanded pack size to 50ml
Metoo status:
Phosvit Injection (50ml) of M/s Selmore Pharmaceuticals (Pvt) Limited, Lahore. (Reg. No.
088081)
 The firm has NOT submitted fee Rs. 30,000/- for revision of pack size.
Decision: Approved with 50ml pack size. Firm shall submit fee Rs. 30,000/- for correction/pre-
approval change of pack size and finished product specifications as per notification No.F.7-
623. Name and address of manufacturer / M/s Vetz Pharmaceutical (Pvt) Ltd, Plot # Q-1, S.I.T.E,
Applicant Kotri, Sindh.
Brand Name +Dosage Form + G-Mox Plus Injection 100ml
Strength
Amoxicillin as Trihydrate…150mg
Gentamicin As Sulphate…40mg
2020
Type of Form Form 5
A Gent 150/40 Injection (100ml) of M/s Eterna Pharma
Me-too status
(Pvt) Ltd., Mirpur, AJK (Reg. No. 113606)
conclusion: Based on the above observation their current
GMP compliance level is rated as good.
X
Form 5, within six months.
 Updated status: Penicillin Area (Liquid Injection) Veterinary section confirmed routine
GMP inspection report based on evaluation conducted dated 20-12-2022.
Decision: Approved. The firm shall submit fee Rs. 7500/- for correction/pre-approval change
in finished product specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-
Case no. 02 Registration applications of newly granted DML or New section (Veterinary)
a. New DML /section
I. M/s Poulvet Pharmaceuticals (Pvt) Ltd, Multan.
CLB in its 290th meeting held on 28th April, 2023 has considered and approved the grant of DML by way of
formulation with following sections.
1. Oral Powder (General) I (Veterinary)
2. Oral Powder (General) II (Veterinary)
3. Oral Liquid/ Drench (General) (Veterinary)
Accordingly, firm has applied for following products for consideration by the Registration Board.
Section No. of Products No. of Molecules
applied applied
Oral Powder (General) I 22 10
(Veterinary)
Oral Powder (General) I (Veterinary)

(22 Products/ 10 Molecules)
624. Name and address of manufacturer / M/s Poulvet Pharmaceuticals Pvt Ltd. 0.5-Km, West Canal,
Applicant 25-Km, Pull Rango, Lahore Road, Multan
Brand Name +Dosage Form + P.Entadine 10 WSP
Strength
2023 (slip No. 1252961726)
Type of Form Form 5
100gm, 250gm, 500gm, 1000gm, 2500gm, 5000gm,
10000gm, 25000gm; Decontrolled
Amancin-10 Powder of M/s Elegance Pharmaceuticals,
Me-too status
Distt. Rawalpindi (Reg. No. 112234)
GMP status New DML
Decision: Registration Board deferred the case forfurther delibeation and directed PE&R
Division to present working paper on international regulatory status of “Amantadine Drug for
Veterinary use”, in upcoming Board meeting.
Brand Name +Dosage Form + P.Entadine 98 WSP
Strength
2023 (slip No. 581489383)
Type of Form Form 5
100gm, 250gm, 500gm, 1000gm, 2500gm, 5000gm,
Vety Amantex 98% Oral Powder of M/s Leads Pharma
Me-too status
(Pvt) Ltd., Islamabad (Reg. No. 094402)
GMP status New DML
Decision: Registration Board deferred the case forfurther delibeation and directed PE&R
Division to present working paper on international regulatory status of “Amantadine Drug for
Veterinary use”, in upcoming Board meeting.
Brand Name +Dosage Form + Chlor-20 Water Soluble Powder
Strength
2023 (slip No. 70443323421)
Type of Form Form 5
Finished product Specification BP vet specifications
100gm, 250gm, 500gm, 1000gm, 2500gm, 5000gm,
Cyclo-Mix 20 of M/s Eterna Pharma (Pvt) Ltd.,
Me-too status
GMP status New DML
Decision: Approved.
Brand Name +Dosage Form + Chlor-25 Water Soluble Powder
Strength
2023 (slip No. 25932412632)
Type of Form Form 5
Finished product Specification BP vet specifications
100gm, 250gm, 500gm, 1000gm, 2500gm, 5000gm,
Amseclor-25% Oral Water Soluble Powder of M/s Aamster
Me-too status
Laboratories, Rawat, Islamabad. (Reg. No. 112282)
GMP status New DML
Decision: Approved.
Brand Name +Dosage Form + Frusa Lex WSP
Strength
Furosemide…20mg
Potassium Chloride…4mg
2023 (slip No. 1565023677)
Pharmacological Group Diuretic/ Electrolytes
Type of Form Form 5
10gm, 100gm, 250gm, 500gm, 1000gm, 2500gm, 5000gm,
Biofurose Water Soluble Powder of M/s Biorise
Me-too status
Pharmaceuticals, Multan. (Reg. No. 111220)
GMP status New DML
Decision: Approved. The firm shall submit fee of Rs. 30,000/- for correction in formulation
(salt form of furosemide), as per notification No.F.7-11/2012-B&A/DRAP dated07-05-2021
Brand Name +Dosage Form + Linco Poul-4.4 Powder
Strength
2023 (slip No. 93276376899)
Type of Form Form 5
10gm, 100gm, 250gm, 500gm, 1000gm, 2500gm, 5000gm,
Lincos-P Oral Powder of M/s. A&K Pharmaceuticals,
Me-too status
GMP status New DML
Decision: Approved.
Brand Name +Dosage Form + Linco Poul-11 Powder
Strength
2023 (slip No. 696562158019)
Type of Form Form 5
10gm, 100gm, 250gm, 500gm, 1000gm, 2500gm, 5000gm,
Eline 11 Powder of M/s. Eterna Pharma (Pvt) Ltd.,
Me-too status
GMP status New DML
Decision: Approved.
Brand Name +Dosage Form + Linco Poul-40 Powder
Strength
2023 (slip No. 257654900)
Type of Form Form 5
10gm, 100gm, 250gm, 500gm, 1000gm, 2500gm, 5000gm,
Z-Linco-40 Water Soluble Powder of M/s. Zoic
Me-too status
International, Lahore (Reg. No. 090658)
GMP status New DML
X
formulation (salt form), as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021.
(salt form), as per notification No.F.7-11/2012-B&A/DRAP dated07-05-2021 before issuance of
Brand Name +Dosage Form + PSL-100 Water Soluble Powder
Strength
Spectinomycin HCl…444.7mg
2023 (slip No. 0390234849)
Type of Form Form 5
10gm, 100gm, 250gm, 500gm, 1000gm, 2500gm, 5000gm,
Bio-Spin Powder of M/s. Bio-Labs (Pvt) Ltd.,
Me-too status
GMP status New DML
formulation (salt form), as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021.
(salt form), as per notification No.F.7-11/2012-B&A/DRAP dated07-05-2021 before issuance of
Brand Name +Dosage Form + Neo Poul-70 Water Soluble Powder
Strength
2023 (slip No. 3308367104)
Type of Form Form 5
10gm, 100gm, 250gm, 500gm, 1000gm, 2500gm, 5000gm,
Neoritis-70 Powder of M/s. Neotech Pharmaceuticals (Pvt)
Me-too status
Ltd. Kamoke (Reg. No. 111420)
GMP status New DML
Decision: Approved.
Strength
2023 (slip No. 69288409686)
Type of Form Form 5
10gm, 100gm, 250gm, 500gm, 1000gm, 2500gm, 5000gm,
Neo-70 Water Soluble Powder of M/s. Eterna Pharma (Pvt)
Me-too status
Ltd., Mirpur, AJK (Reg. No.113522)
GMP status New DML
Decision: Approved.
Strength
2023 (slip No. 092542933)
Type of Form Form 5
10gm, 100gm, 250gm, 500gm, 1000gm, 2500gm, 5000gm,
Neorox-100 Water Soluble Powder of M/s. Vetrox
Me-too status
Pharmaceutical Pvt Ltd, Toba Tek Singh. (Reg. No.
111294)
GMP status New DML
Decision: Approved.
Brand Name +Dosage Form + Poul Amp-30 Water Soluble Powder
Strength
2023 (slip No. 58141303)
Type of Form Form 5
10gm, 100gm, 250gm, 500gm, 1000gm, 2500gm, 5000gm,
Roxaprol Water Soluble Powder of M/s. Vetrox
Me-too status
Pharmaceutical Pvt Ltd, Toba Tek Singh. (Reg. No.111284)
GMP status New DML
Decision: Approved.
Strength
2023 (slip No. 950151957100)
Type of Form Form 5
10gm, 100gm, 250gm, 500gm, 1000gm, 2500gm, 5000gm,
Kryprolium Oral Powder of M/s. Krypton Pharma (Pvt)
Me-too status
Ltd., Faisalabad (Reg. No. 113424)
GMP status New DML
Decision: Approved.
Strength
2023 (slip No. 01722464150)
Type of Form Form 5
10gm, 100gm, 250gm, 500gm, 1000gm, 2500gm, 5000gm,
Pentaprol 90 Powder of M/s. Neotech Pharmaceuticals (Pvt)
Me-too status
Ltd. Kamoke (Reg. No. 111416)
GMP status New DML
Decision: Approved.
Brand Name +Dosage Form + Doxs-20 Water Soluble Powder
Strength
Doxycycline Hyclate…200mg
2023 (slip No. 32416516)
Type of Form Form 5
10gm, 100gm, 250gm, 500gm, 1000gm, 2500gm, 5000gm,
Eter Doxycycline -20 Powder of M/s. Eterna Pharma (Pvt)
Me-too status
GMP status New DML
Decision: Approved.
Strength
2023 (slip No. 6187042492)
Type of Form Form 5
10gm, 100gm, 250gm, 500gm, 1000gm, 2500gm, 5000gm,
Dox Reena 50% Water Soluble Powder of M/s. Kayans
Me-too status
Pharmaceuticals, Rawat, Rawalpindi (Reg. No. 111574)
GMP status New DML
Decision: Approved.
Strength
2023 (slip No. 2165283095)
Type of Form Form 5
10gm, 100gm, 250gm, 500gm, 1000gm, 2500gm, 5000gm,
Eter Doxycycline -80 Water Soluble Powder of M/s. Eterna
Me-too status
Pharma (Pvt) Ltd., Mirpur, AJK (Reg. No.109849)
GMP status New DML
Decision: Approved.
Brand Name +Dosage Form + Poultin-48 Water Soluble Powder
Strength
2023 (slip No. 27744839792)
Type of Form Form 5
100gm, 250gm, 500gm, 1000gm, 2500gm, 5000gm,
Coli Skill-48 Powder of M/s. Bioskils Pharmaceuticals,
Me-too status
Sadhoke, District Gujranwala (Reg. No.113508)
GMP status New DML
Decision: Approved.
Strength
2023 (slip No. 8174851150)
Type of Form Form 5
100gm, 250gm, 500gm, 1000gm, 2500gm, 5000gm,
Colicid Water Soluble Powder of M/s. Eterna Pharma (Pvt)
Me-too status
GMP status New DML
Decision: Approved.
Strength
2023 (slip No. 82703865)
Type of Form Form 5
100gm, 250gm, 500gm, 1000gm, 2500gm, 5000gm,
Neflorex 60 Water Soluble Powder of M/s. Eterna Pharma
Me-too status
(Pvt) Ltd., Mirpur, AJK (Reg. No. 113529)
GMP status New DML
Decision: Approved.
Brand Name +Dosage Form + Poul CNC Water Soluble Powder
Strength
Colistin Sulphate…4mg
Chlortetracycline…80mg
2023 (slip No. 526451523)
Type of Form Form 5
100gm, 250gm, 500gm, 1000gm, 2500gm, 5000gm,
SB Neocotin Soluble Powder of M/s. SB Pharma,
Me-too status
GMP status New DML
Firm shall submit fee of Rs.30000/- for correction in
formulation (salt form of Chlortetracycline), as per
notification No.F.7-11/2012-B&A/DRAP dated 07-05-
2021.
(salt form of Chlortetracycline), as per notification No.F.7-11/2012-B&A/DRAP dated07-05-
Case no. 03 Registration applications of import cases

a. New Cases (Veterinary)
646. Name and address of Applicant M/s Mian Traders, Railway Road Morre Eimenabad, Gujranwala,
Punjab, Pakistan
Detail of Drug Sale License Name: M/s Mian Traders
Address: Railway Road Morre Eimenabad, Gujranwala, Punjab,
Pakistan
Validity: 22-01-2022.
Status: License to sell drugs as a distributor (Form No.11).
Name and address of manufacturer M/s Al-Mutawwaj Veterinary Pharmaceutical Industries (Spectra
Vet), King Abdullah II, Ibn Al-Hussein Industrial Zone, Sahab,
Amman, Jordan Street 16, Building 401
Name and address of marketing M/s Al-Mutawwaj Veterinary Pharmaceutical Industries (Spectra
authorization holder Vet),P.O Box 202, Amman 11512 Jordan
Name of exporting country Jordan
Type of Form Form-5A
Diary No. & Date of R& I Dy.No 19012 Dated 07-07-2021
Fee including differential fee Rs : 150,000 Dated 05-07-2021 (slip N0. 62298092001)
Brand Name +Dosage Form + Spectra Flor Solution
Strength
Florfenicol…100mg
Finished Product Specification Inhouse
Shelf life 03 Years
Demanded Price Decontrolled
Pack size 1000ml
International availability N/A
Me-too status Technoflor-10 Liquid of M/s Neotech Pharmaceuticals (Pvt) Ltd.
Chak Hinda Kamoke. (Reg. No. 111444)
Detail of certificates attached  Originally legalized CoPP No. 011225 dated 26.11.2020
certified by Ministry of Agriculture, Veterinary Department
Jordan, confirms GMP status of the manufacturer as well as free
sale status of the applied product in country of origin.
 Letter of authorization/ distribution agreement between the
MAH and the applicant is not provided.
Remarks of the Evaluator X Firm has provided 06-month accelerated and 36-month real time
stability studies data of three batches at zone IV-A conditions.
 Same formulation of the same MAH has also been applied by
M/s Aves Care, Faisalabad. (Considered and deferred in 324th
meeting of the Registration Board). Letter of authorization/
distribution agreement between the MAH and the applicant
has not been provided by both the firms.
Shortcomings:
 Provide copy of valid DSL
 Provide valid notarized original letter of authorization (LOA)/
distribution agreement
 In the finished product label the Urdu version of the following
namely; (i) Name of drug (ii) dosage; and (iii) Instruction is
missing. Submit label in accordance with The Drugs (Labeling
and Packing) Rules, 1986.
 copy of valid DSL
 valid notarized copy of letter of authorization (LOA)/ distribution agreement
 label in accordance with The Drugs (Labeling and Packing) Rules, 1986.
Punjab, Pakistan
Pakistan
Validity: 22-01-2022.
Fee including differential fee Rs : 150,000 Dated 05-07-2021 (slip N0. 3517477914)
Brand Name +Dosage Form + Spectra Col Forte Powder
Strength
Colistin as Sulphate…6,000,000 IU
Shelf life 03 Years
Pack size 500gm, 1000gm
Me-too status Neflorex 60 Water Soluble Powder of M/s Eterna Pharma (Pvt)
Ltd., Mirpur, AJK. (Reg. No. 113529)
Shortcomings:
publication of the minutes.
Punjab, Pakistan
Pakistan
Validity: 22-01-2022.
Fee including differential fee Rs: 150,000 Dated 05-07-2021 (slip N0. 6726172802)
Brand Name +Dosage Form + Spectra Tilcosin Solution
Strength
Tilmicosin as Phosphate…250mg
Shelf life 03 Years
Pack size 240ml, 960ml
Me-too status Kptil Oral 25% Oral Liquid of M/s Krypton Pharma (Pvt) Ltd.,
Shortcomings:
Punjab, Pakistan
Pakistan
Validity: 22-01-2022.
Name and address of M/s Al-Mutawwaj Veterinary Pharmaceutical Industries (Spectra
manufacturer Vet), King Abdullah II, Ibn Al-Hussein Industrial Zone, Sahab,
Brand Name +Dosage Form + Spectra Brom D.S Solution
Strength
Shelf life 02 Years
Me-too status Vet Brom 1% Oral Liquid of M/s Kayans Pharmaceuticals,
Rawat, Rawalpindi. (Reg. No. 113490)
Jordan, confirms GMP status of the manufacturer as well as
free sale status of the applied product in country of origin.
Shortcomings:
Punjab, Pakistan
Pakistan
Validity: 22-01-2022.
Name and address of M/s Al-Mutawwaj Veterinary Pharmaceutical Industries (Spectra
manufacturer Vet), King Abdullah II, Ibn Al-Hussein Industrial Zone, Sahab,
Brand Name +Dosage Form + Spectra Dox Forte Powder
Strength
Shelf life 03 Years
Me-too status Farmadox 50 Oral Powder of M/s ZS Biotech, Lahore. (Reg. No.
113635)
Jordan, confirms GMP status of the manufacturer as well as
free sale status of the applied product in country of origin.
Shortcomings:
distribution agreement.
 The official monograph of the applied formulation exists in
USP 44-NF 39 which states that “Doxycycline for Oral
Suspension contains the equivalent of NLT 90.0% and NMT
125.0% of the labeled amount of doxycycline (C22H24N2O8)
when constituted as directed.”
 The firm shall submit fee Rs. 150,000/- for revision of
formulation in line with pharmacopoeia and correction/pre-
approval change in finished product specifications as per
 fee Rs. 150,000/- for revision of formulation in line with pharmacopoeia and correction/pre-
approval change in finished product specifications as per notification No.F.7-11/2012-
651. Name and address of Applicant M/s Unicare Enterprises, Commercial-6, Block A, Kazimabad,
Model Colony, Karachi-75100, Pakistan
Detail of Drug Sale License Name: M/s Unicare Enterprises
Address: Plot No. 587/1-B, Srtreet No. 3 Punjab Small Industrial
Estate, Nalka Kohala Sargodha Road Faisalabad.
Validity: 10-04-2022.
Name and address of Medicavet Tarim ve Hayvancilik Ilac ve Kimya San. Tic. Ltd. Sti.
manufacturer ITOSB Eski Ankara Asfalti 34959 12. Cad. No: 1 Tepeoren
Tuzla/Istanbul-Turkey
Name and address of marketing Medicavet Tarim Hayvancilik Ilac ve Kimya San. Tic. Ltd. Sti.
authorization holder Itosb Tuzla Organize San. Bolgesi Eski Ankara Asfalti 12. Cad.
No: 1 Tepeoren Tuzla/Istanbul-Turkey
Brand Name +Dosage Form + Oksimed Water Soluble Powder
Strength
Oxytetracycline HCl Eq. to Oxytetracycline Base…500mg
Shelf life 36 months
Pack size 100gm, 250gm, 500gm, 1000gm and 5000gm
Me-too status Oxyveto-50 S Soluble Powder of M/s Orient Traders
International, Karachi. (Reg. No. 049545)
Detail of certificates attached  Originally legalized FSC certified by Ministry of Agriculture
and Forestry, General Directorate of Food and Control
Republic of Turkey free sale status of the applied product in
country of origin.
 Scanned copy of legalized GMP certificate No.
GMP/TR/V/YI/S00137/2019 dated 27.03.2019 certified by
Ministry of Agriculture and Forestry Turkey. (Originally
legalized in Medicatay Water Soluble granules dossier)
 Scanned copy of sole and exclusive distribution letter, dated
16-10-2019, between the MAH and the applicant.
Shortcomings:
 Provide valid legalized original GMP certificate, since the
already submitted scanned copy is expired now but valid
upon submission.
distribution agreement, since the already submitted is scanned
copy.
 Oxytetracycline HCl Eq. to Oxytetracycline Base…500mg
is mentioned on Form 5A while Oxytetracycline
HCl…500mg is mentioned on FSC; clarification regarding the
applied formulation is required.
 Address of the firm mentioned on DSL is “Plot No. 587/1-B,
Street No. 3 Punjab Small Industrial Estate, Nalka Kohala
Sargodha Road Faisalabad.” while “Commercial-6, Block A,
Kazimabad, Model Colony, Karachi” is mentioned on form-
5A, clarify.
 valid legalized original GMP certificate
 clarification regarding the applied formulation since Oxytetracycline HCl Eq. to
Oxytetracycline Base…500mg is mentioned on Form 5A while Oxytetracycline HCl…500mg
is mentioned on FSC
 clarification regarding address of the applicant mentioned on DSL, since “Plot No. 587/1-B,
Street No. 3 Punjab Small Industrial Estate, Nalka Kohala Sargodha Road Faisalabad.” Is
mentioned on DSL while “Commercial-6, Block A, Kazimabad, Model Colony, Karachi is
mentioned on form-5A
 label in accordance with The Drugs (Labeling and Packing) Rules, 1986
Validity: 10-04-2022.
Name and address of M/s Idol Ilac Dolum San. Ve Tic.A.S.
manufacturer Davutpasa Cad. Cebealibey Sok. No: 20 34010
Zeytinburnu/Istanbul
Brand Name +Dosage Form + Tilotarmed 20% Solution for Injection
Strength
Tylosin Tartrate Eq. to Tylosin Base…200mg
Pack size 100ml
Me-too status Tylox-20 Injection (100ml) of M/s Eterna Pharma (Pvt) Ltd.,
country of origin.
legalized in Tilomed-E 30% Solution for Injection)
Shortcomings:
already submitted scanned copy is expired now but valid
upon submission.
copy.
5A, clarify.
Validity: 10-04-2022.
Name and address of M/s Idol Ilac Dolum San. Ve Tic.A.S.
manufacturer Davutpasa Cad. Cebealibey Sok. No: 20 34010
Zeytinburnu/Istanbul
Brand Name +Dosage Form + Tilomed-E 30% Solution for Injection
Strength
Tilmicosin Phosphate Eq. to Tilmicosin Base…300mg
Pack size 100ml
Me-too status Mico Sol Injection (100ml) of M/s Elko Organization (Pvt.) Ltd,
country of origin.
 Originally legalized GMP certificate No.
Ministry of Agriculture and Forestry Turkey.
Shortcomings:
already submitted is expired now but valid upon submission
copy.
5A, clarify.
Validity: 10-04-2022.
Name and address of marketing Medicavet Tarim ve Hayvancilik Ilac ve Kimya San. Tic. Ltd. Sti.
authorization holder ITOSB Eski Ankara Asfalti 34959 12. Cad. No: 1 Tepeoren
Brand Name +Dosage Form + Medicatay Water Soluble granules
Strength
Tylosin Tartrate Eq. to Tylosin Base…1000mg
Pack size 22gm, 55gm, 110gm, 100gm, 500gm, 550gm, 1000gm, 1100gm
Me-too status Tylo Tartrate-100 Oral Powder of M/s Eterna Pharma (Pvt) Ltd.,
country of origin.
 Originally legalized GMP certificate No.
Ministry of Agriculture and Forestry Turkey.
Shortcomings:
copy.
5A, clarify.
namely; (i) Name of drug and (ii) dosage is missing. Submit
label in accordance with The Drugs (Labeling and Packing)
Rules, 1986.
Validity: 10-04-2022.
Brand Name +Dosage Form + Tilomed 30% Oral Solution
Strength
Tilmicosin Phosphate Eq. to Tilmicosin Base…300mg
Pack size 70 x 250ml, 50 x 500ml, 10 x 1000ml bottles,
3 x 5000ml drum
country of origin.
Shortcomings:
copy.
5A, clarify.
Rules, 1986.
DRAP (generic / me-too status) along with registration
along with registration number, brand name and name of firm.
Validity: 10-04-2022.
Brand Name +Dosage Form + Mediquinol 20% Oral Solution
Strength
Pack size 100ml, 200ml, 250ml, 500ml, 1000ml, 2500ml
Me-too status Bovicin-20 Oral Solution of M/s Eterna Pharma (Pvt) Ltd.,
Mirpur, AJK (Reg. No.112149)
country of origin.
Shortcomings:
copy.
5A, clarify.
Rules, 1986.
Validity: 10-04-2022.
Brand Name +Dosage Form + NS-Med 50% Oral Solution Powder
Strength
Neomycin Sulphate 715mg Eq. to Neomycin Base…500mg
Pack size 20gm, 100gm, 500gm, 1000gm, 2500gm
country of origin.
Shortcomings:
copy.
5A, clarify.
Rules, 1986.
Validity: 10-04-2022.
Brand Name +Dosage Form + Tetraklor Water Soluble Powder
Strength
Chlortetracycline Base…600mg
Pack size 20gm, 100gm, 500gm, 1000gm, 2500gm
country of origin.
Shortcomings:
copy.
5A, clarify.
Rules, 1986.
 Chlortetracycline Base…600mg/gram is mentioned on Form
5A while Chlortetracycline HCl…600mg/gram is mentioned
on FSC; clarification regarding the applied formulation is
required.
 clarification regarding the applied formulation since Chlortetracycline Base…600mg/gram is
mentioned on Form 5A while Chlortetracycline HCl…600mg/gram is mentioned on FSC
659. Name and address of Applicant M/s Aves Care,
Office Address: P-74, Street No. 3, Rehman town, Satiana Road,
Faisalabad.
Warehouse Address: P-68, Street No. 3, Rehman Town, Satiana
Road, Faisalabad, Pakistan
Detail of Drug Sale License Not Provided
Name and address of M/s Cenavisa S.L. Cami Pedra Estela, s/n 43205 Reus, Spain
manufacturer
Name and address of marketing M/s Cenavisa S.L. Cami Pedra Estela, s/n 43205 Reus, Spain
Name of exporting country Spain
Fee including differential fee Rs : 1,50,000 Dated 02-09-2021 (slip No. 9111732823)
Brand Name +Dosage Form + Doxycen 500 powder
Strength
Doxycycline (Hyclate)…500mg
Finished Product Specification Eur. Ph. specifications
Shelf life 2 years
Me-too status Farmadox 50 Oral Powder of M/s. ZS Biotech, Lahore. (Reg. No.
113635)
Detail of certificates attached  Original legalized Certificate of Pharmaceutical Product
Certificate No. 2021/272 Issued on 25-03-2021, Certified by
Spanish agency of Medicines and Medical Devices, Spain. The
CoPP confirms free sale status of the product in exporting
country as well as GMP status of the manufacturer.
 Sole agency certificate between MAH and the applicant is not
provided.
Remarks of the Evaluator X Provided 06 months accelerated and 24 months real time stability
study data of 03 batches according to zone IV-A conditions.
Shortcomings:
 Provide notarized original valid Letter of Authorization/
Sole agency certificate.
 In the finished product label the Urdu version of the
following namely; (i) Name of drug (ii) dosage and (iii)
instructions is missing. Submit label in accordance with
The Drugs (Labeling and Packing) Rules, 1986.
 notarized original valid Letter of Authorization/ Sole agency certificate.
660. Name and address of Applicant M/s Qualivet Pharma,
Office address: 1st Floor, B-16, Block A, Kazimabad, Near
Masjid-e-Hira, Model Colony, Karachi-75100, Pakistan
Godown Address: No. 5/15, Golden Town, Survey No. 79, Malir
Halt, Karachi, Pakistan
Detail of Drug Sale License Name: M/s Qualivet Pharma
Address: No. 5/15, Golden Town, Survey No. 79, Malir Halt,
Karachi,
Validity: 14-10-2022.
Status: Drug License by way of Wholesale (Form No.7).
Name and address of M/s Laboratories SYVA S.A.U
manufacturer Avda. Portugal, s/n, Parque technologico de Leon, Parcelas 15-16,
Leon 24009 Leon Spain
Name and address of marketing M/s Laboratories SYVA S.A.U
authorization holder Avda. Parroco Pablo Diez, 49-57 (24010) Leon Spain
Fee including differential fee Rs : 150,000 Dated 26-08-2021 (slip No. 86671310068)
Brand Name +Dosage Form + Actionis Suspension for Injection
Strength
Ceftiofur as Ceftiofur HCl…50mg
Pack size 100ml, and 250ml
Me-too status Calicef 50mg Suspension for Injection (100ml) of M/s Orient
Animal Health (Pvt) Ltd., Karachi. (Reg. No. 108996)
Detail of certificates attached  Scanned copy of CoPP dated 17-12-2020 issued by Spanish
agency of Medicines and Medical Devices, Spain confirming
the free sale status in exporting country as well as GMP status
of the manufacturer
 Scanned copy of declaration dated 09-02-2021 of sole and
exclusive distribution valid for 5 years
Remarks of the Evaluator X Provided 06 months accelerated and 24 months long term stability
studies data as per zone-IV-A conditions.
Shortcomings:
 Provide notarized original valid Letter of Authorization/ Sole
agency certificate since already submitted is scanned copy.
 Provide legalized original valid CoPP since already submitted
is scanned copy.
 Confirmation of dedicated manufacturing facility
250ml pack sizes of injectable dosage form are demanded in a
single application. So clarification is required for which pack
size/ fill volume you want to apply this dossier and provide
accordingly, evidence of applied formulation/drug already
approved by DRAP (generic / me-too status) along with
 legalized original valid CoPP
 confirmation of dedicated manufacturing facility
 choice of only one pack size
Karachi,
Validity: 14-10-2022.
Brand Name +Dosage Form + Amoxoil Retard Suspension for Injection
Strength
Amoxicillin as Amoxicillin Trihydrate…150mg
Me-too status Amocillin 15% Injection (100ml) of M/s Eterna Pharma (Pvt)
Ltd.,Mirpur, AJK (Reg. No. 113596)
of the manufacturer
exclusive distribution in Actionis Suspension for Injection
dossier; valid for 5 years
Shortcomings:
is scanned copy.
Karachi,
Validity: 14-10-2022.
Brand Name +Dosage Form + Dexabiopen Suspension for Injection
Strength
Benzyl Penicillin (Procaine)…200mg
Dihydrostreptomycin (sulfate)…200mg
Dexamethasone…0.5mg
Pharmacological Group Antibacterial and corticosteroid
of the manufacturer
exclusive distribution; valid for 5 years
X
Remarks of the Evaluator Provided only 12 months long term stability studies data as per
zone-IV-A conditions.
Shortcomings:
is scanned copy.
 Provide 06 months accelerated and real time stability studies
data upto claimed shelf life as per zone IV-A conditions.
Karachi,
Validity: 14-10-2022.
Fee including differential fee Rs : 150,000 Dated 26-08-2021 (slip No.23252367362)
Brand Name +Dosage Form + Exabiopen Suspension for Injection
Strength
Benzyl Penicillin (Procaine)…200,000 IU
Dihydrostreptomycin sulfate…250mg
of the manufacturer
exclusive distribution; valid for 5 years
Remarks of the Evaluator X Provided only 12 months long term stability studies data as per
zone-IV-A conditions.
Shortcomings:
 Provide legalized original valid Letter of Authorization/ Sole
is scanned copy.
 06 months accelerated and real time stability studies data upto claimed shelf life as per
zone IV-A conditions
Karachi,
Validity: 14-10-2022.
Name and address of M/s Zoopan-Produtos Pecuarios S.A.
manufacturer Rua Da Liberdade, 77, 2050-023 Aveiras De Baixo, Portugal
Name and address of marketing M/s Zoopan-Produtos Pecuarios S.A.
authorization holder Rua Da Liberdade, 77, 2050-023 Aveiras De Baixo, Portugal
Name of exporting country Portugal
Brand Name +Dosage Form + Micoresp Water Soluble Powder
Strength
Bromhexine Chlorhydrate…3.50mg
Pharmacological Group Antibacterial/ Expectorant, mucolytic
Pack size 100gm, 500gm and 1000gm
Detail of certificates attached  Unattested photocopy of CoPP No. 208/CMVPT/2018
certified by The General Directorate of Food and Veterinary
confirming the free sale status in exporting country as well as
GMP status of the manufacturer
 Photocopy of declaration (not legalized) dated 10-08-2021 of
sole and exclusive distribution; valid for 5 years
Remarks of the Evaluator X The firm has not provided stability studies data as per zone-IV-A
conditions.
Shortcomings:
agency certificate since already submitted is copy not even
legalized.
is unattested copy.
 Provide evidence of applied formulation/drug already
Karachi,
Validity: 14-10-2022.
Name and address of M/s Zoopan-Produtos Pecuarios S.A.
manufacturer Rua Da Liberdade, 77, 2050-023 Aveiras De Baixo, Portugal
Name and address of marketing M/s Zoopan-Produtos Pecuarios S.A.
authorization holder Rua Da Liberdade, 77, 2050-023 Aveiras De Baixo, Portugal
Name of exporting country Portugal
Brand Name +Dosage Form + Enroxina Solution for Oral Administration
Strength
Pack size 100ml, 1000ml, and 5000ml
Me-too status Hipralona / Enro-S Oral Solution of M/s Aims Traders Karachi
(Reg. No. 017080)
Detail of certificates attached  Unattested photocopy of CoPP No. 207/CMVPT/2018
certified by The General Directorate of Food and Veterinary
confirming the free sale status in exporting country as well as
GMP status of the manufacturer
 Photocopy of declaration (not legalized) dated 10-08-2021 of
sole and exclusive distribution; valid for 5 years
Remarks of the Evaluator X The firm has not provided stability studies data as per zone-IV-A
conditions.
Shortcomings:
agency certificate since already submitted is copy not even
legalized.
is unattested copy.
666. Name and address of Applicant M/s Neovet Pharma Pvt Ltd. Street No. 6, Plot No. A 12/37,
Commercial Area Landhi, Cattle Colony Karachi
Detail of Drug Sale License Name: M/s Neovet Pharma Pvt Ltd
Address: Plot No. A 12/37, Street No. 6, Commercial Area
Landhi, Cattle Colony Karachi
Validity: 12-07-2023.
Name and address of M/s Hebei New Century Pharmaceutical Co. Limited.
manufacturer 189 Taihang Street, Shijiazhuang,Hebei, P.R.China 050035
Name and address of marketing M/s Hebei New Century Pharmaceutical Co. Limited.
authorization holder 189 Taihang Street, Shijiazhuang,Hebei, P.R.China 050035
Name of exporting country China
Diary No. & Date of R& I Dy. No 25220 Dated 10-09-2021
Brand Name +Dosage Form + Flumine Plus 8% Injection 100ml
Strength
Finished Product Specification USP specifications
Pack size 100ml
Detail of certificates attached  Original embassy attested CoPP No. 2021042901 certified by
Agriculture office of Shijiazhuang High-tech zone Huanghe
Road No. 151, China confirming the free sale status in
exporting country as well as GMP status of the manufacturer
Vaidity: 28-04-2026
 Photocopy of agency agreement dated 06-05-2021 between
PLH and the applicant; valid for 5 years
Remarks of the Evaluator X The firm has provided 06-month accelerated and 36-month real
time stability studies data as per zone-IV-A conditions.
Shortcomings:
agency certificate since already submitted is copy
 Provide evidence of applied formulation/drug already
publication of the minutes,
Validity: 12-07-2023.
Brand Name +Dosage Form + Neogent 10% Injection
Strength
Gentamycin Sulphate…100mg
Pack size 100ml
Me-too status Genster 10 Injection (100ml) of M/s Aamster Laboratories,
Rawat, Islamabad. (Reg. No. 111395)
Vaidity: 28-04-2026
Shortcomings:
 Attested copy of valid DSL
 Notarized copy valid Letter of Authorization/ Sole agency certificate.
Validity: 12-07-2023.
Brand Name +Dosage Form + Solo-P 50ml Injection
Strength
Prednisolone…10mg
Chlorpheniramine Maleate…4mg
Finished Product Specification Inhouse specifications
Pharmacological Group Bacteriostatic/ antihistamine
Pack size 50ml
Me-too status Chlorprem 14 Injection (50ml) of M/s Kayans Pharmaceuticals,
Vaidity: 28-04-2026
Shortcomings:
Validity: 12-07-2023.
Brand Name +Dosage Form + N-Flor 30 Injection 50ml
Strength
Florfenicol…300mg
Finished Product Specification CVP specifications
Pack size 50ml
Me-too status G-Flor 30% Injection (50ml) of M/s Grand Pharma (Pvt) Ltd.,
Vaidity: 28-04-2026
Shortcomings:
Validity: 12-07-2023.
Brand Name +Dosage Form + Trizole 100ml Injection
Strength
Sulfadiazine…200mg
Trimethoprim…40mg
Pack size 100ml
Me-too status Kerry T.S Injection (100ml) of M/s Bio-Labs (Pvt) Ltd.,
Vaidity: 28-04-2026
Shortcomings:
Validity: 12-07-2023.
Brand Name +Dosage Form + Dimipro Plus 2.36gm Granules for Injection
Strength
Composition Per Unit contains:
Diminazene Aceturate…1.05g
Vitamin B6…5mg
Vitamin B12…1mg
Antipyrine add to ......2.36g
Pharmacological Group Antiprotozoal
Pack size 2.36gm bag
Vaidity: 28-04-2026
Shortcomings:
 notarized original valid Letter of Authorization/ Sole
following namely; (i) Name of drug (ii) dosage; and (iii)
Instruction is missing. Submit label in accordance with
 evidence of applied formulation/drug already approved by
Validity: 12-07-2023.
Brand Name +Dosage Form + Neomec Super 100ml Injection
Strength
Ivermectin…20mg
Clorsulon…100mg
Pharmacological Group Antiparasitic
Pack size 100ml
Me-too status Iver-Soun Injection (100ml) of M/s Cherished Pharmaceuticals
(Pvt) Ltd., Lahore. (Reg. No. 109793)
Vaidity: 28-04-2026
Shortcomings:
Validity: 12-07-2023.
Brand Name +Dosage Form + Neomec-DS 100ml Injection
Strength
Ivermectin…40mg
Pack size 100ml
Vaidity: 28-04-2026
Shortcomings:
 evidence of applied formulation/drug already approved by
along with registration number, brand name and name of firm
Validity: 12-07-2023.
Brand Name +Dosage Form + Neoflox-20 50ml Injection
Strength
Pharmacological Group Bacteriostatic
Pack size 50ml
Vaidity: 28-04-2026
Shortcomings:
Validity: 12-07-2023.
Brand Name +Dosage Form + Tonophos-B 100ml Injection
Strength
Tonophosphan…124.4mg
Vitamin B12…0.05mg
Pharmacological Group Nutritional supplements
Pack size 100ml
Me-too status New Dechaphosphan Injection (100ml) of M/s Atzan
Pharmaceuticals, Sargodha. (Reg. No. 039972)
Vaidity: 28-04-2026
Shortcomings:
Validity: 12-07-2023.
Brand Name +Dosage Form + Neo AD3E 100ml Injection
Strength
Vitamin E…20mg
Pharmacological Group Nutrients
Pack size 100ml
Me-too status Trivetz Injection (100ml) of M/s Vetz Pharmaceuticals (Private)
Limited., Kotri Sindh. (Reg. No. 079285)
Vaidity: 28-04-2026
Shortcomings:
Validity: 12-07-2023.
Brand Name +Dosage Form + Oligovit-M 100ml Injection
Strength
Vitamin A, Retinol Palmitate…15,000 IU
Vitamin D3, Cholecalciferol...7500 IU
Vitamin E, Tocopherol Acetate...20mg
Thiamine HCl...10mg
Riboflavine Sodium Phosphate...5mg
Pyridoxine HCl...3mg
Cyanocobalamin...60mcg
D-Panthenol...25mg
Nicotinamide...50mg
Folic Acid...150mg
Biotin...125mg
Amino Acids...12mg
Water for Injection...1ml
Pharmacological Group Vitamin supplements
Pack size 100ml
Vaidity: 28-04-2026
Shortcomings:
 Specify which amino acids are included in the formulation
and accordingly, provide evidence of applied
formulation/drug already approved by DRAP (generic /
me-too status) along with registration number, brand name
and name of firm.
 Specify which amino acids are included in the formulation and accordingly, provide
evidence of applied formulation/drug already approved by DRAP (generic / me-too status)
Validity: 12-07-2023.
Brand Name +Dosage Form + Neovital Fort 250ml Injection
Strength
L-Arginine HCl...1.425mg
L-Cysteine HCl...0.02mg
L-Histidine HCl...0.02mg
L-Isoleucine...0.525mg
L-Leucine HCl...0.6mg
L-Methionine...0.525mg
L-Threonine...0.35mg
L-Tryptophan...0.175mg
L-Phenylalanine...0.35mg
L-Valine...0.525mg
L-Lysine HCl...0.525mg
Monosodium Glutamate...0.08mg
Riboflavin...0.05mg
D-Pantothenol ...0.1mg
Nicotinamide...3mg
Thiamine HCl...0.1mg
Glucose...50mg
Calcium Chloride...2mg
Potassium Chloride...2mg
Magnesium Sulphate...2mg
Sodium Acetate...7.5mg
Water for Injection...1ml
Pharmacological Group Vitamin supplements
Pack size 250ml
Me-too status Enersel Injection (250ml) of M/s Selmore Pharmaceuticals (Pvt)
Limited, Lahore. (Reg. No. 112275)
Vaidity: 28-04-2026
Shortcomings:
679. Name and address of Applicant M/s Chakwal Pharma International, OTI Plaza, Basement
Ground, 1st ,2nd & 3rd floor, 210 Lalazar Commercial Market,
Thokar Niaz Baig, Raiwind Road, Lahore
Detail of Drug Sale License Address: OTI Plaza, Basement Ground, 1st ,2nd & 3rd floor, 210
Lalazar Commercial Market, Thokar Niaz Baig, Raiwind Road,
Lahore
Status: License to sell drugs as a Distributor (Form No. 11)
Name and address of M/S. Alfasan, Netherland B.V. Kuipersweg 9, 3449 JA Woerden
manufacturer The Netherland
Name and address of marketing M/S. Alfasan, Netherland B.V. Kuipersweg 9, 3449 JA Woerden
authorization holder The Netherland
Name of exporting country The Netherland
Diary No. & Date of R& I Dy No : 28429 Dated 15-10-2021
Fee including differential fee Rs : 150,000 Dated 20-09-2021(Slip No. 843490248510)
Brand Name +Dosage Form + Alfamec 1% Solution for Injection
Strength
Ivermectin…10mg
Finished Product Specification BP specifications
Shelf life 3 years
Pack size 500ml
International availability Not applicable
Me-too status Mac Rold 1% Liquid Injection (500ml) of M/s Haarolds
Pharmaceuticals (Pvt) Ltd., Bhimber, AJK. (Reg. No. 106818)
Detail of certificates attached  Photocopy of embassy attested COPP BD/2017/No. of
Certificate 247607 dated 13-06-2017 certified by Medicines
Evaluation Board Agency- Veterinary Medicinal Products
Unit, Ministry of Economic Affairs, The Netherlands confirms
of the manufacturer
(Copy of COPP attached original was submitted for its pack
size 100 mL registered, reg. No. 103795 dossier submission date
17-11-2017.)
 Photocopy of letter of exclusive sole distributor/ authorization
dated: 05-05-2017
copy is expired now but valid upon submission.
agency certificate since already submitted copy is expired
now but valid upon submission.
 notarized original valid Letter of Authorization/ Sole agency certificate
zone IV-A conditions.
Lahore
Brand Name +Dosage Form + Lincomycin-Spectinomycin 5/10 Solution for Injection
Strength
Lincomycin as HCl…50mg
Spectinomycin as HCl…100mg
Finished Product Specification As per innovator’s specifications
Pharmacological Group Antibiotics
Shelf life 3 years
Pack size 100ml
Me-too status Spectral Injection (100ml) of M/s Nawal Pharmaceuticals,
Taxila-Rawalpindi (Reg. No. 113610)
Detail of certificates attached  Scanned copy of embassy attested COPP BD/2017/No. of
of the manufacturer
(Copy of COPP attached, original was submitted for its pack
17-11-2017.)
dated: 05-05-2017
Shortcomings:
Lahore
Brand Name +Dosage Form + Multivitamins Solution for Injection
Strength
Cholecalciferol…1000 IU
Alfa-Tocoferol Acetate…20mg
Thiamine HCl…10mg
Riboflavin Sodium Phosphate…6.85mg
Pyridoxine HCl…3mg
Cyanocobalamine…50mcg
Nicotinamide…35mg
D-Panthenol…25mg
Finished Product Specification As per innovator’s specifications
Pharmacological Group Multivitamins
Shelf life 3 years
Pack size 100ml
Detail of certificates attached  Scanned copy of embassy attested COPP BD/2017/No. of
of the manufacturer
(Copy of COPP attached, original was submitted for its pack
17-11-2017.)
dated: 05-05-2017
Shortcomings:
682. Name and address of Applicant M/s Orion Group, P-97, Usman Block, Muslim Town No.1, Near
Lasani Pully, Sargodha Road, Faisalabad
Detail of Drug Sale License M/s Orion Group,
Address: 97 Commercial Area, Usman Block, Muslim Town
No.1, Sargodha Road, Faisalabad
Name and address of M/s S.P. Veterinaria, S.A.
manufacturer Crta. Reus-Vinyols, Km. 4.1 P.O Box 60, 43330, RIUDOMS
(Tarragona) Spain.
Name and address of marketing M/s S.P. Veterinaria, S.A.
authorization holder Crta. Reus-Vinyols, Km. 4.1 P.O Box 60, 43330, RIUDOMS
(Tarragona) Spain.
Brand Name +Dosage Form + Floxavex 100mg/ml Solution for Injection
Strength
Shelf life 3 years
Me-too status Enro-Pro 10 Injection (100ml) of M/s Eterna Pharma (Pvt) Ltd
Detail of certificates attached  Original legalized COPP dated 13-07-2021 issued by Spanish
Agency for Medicines and Health Products confirms free sale
status of the product in exporting country as well as GMP
status of the manufacturer
 Distribution agreement between PLH and the applicant is not
provided.
 Provide valid copy of DSL
 Notarized original sole agency/distribution agreement between
PLH and Applicant
 Provide accelerated and real time stability studies data of three
batches as per zone IV-A conditions upto claimed shelf life.
 06 month accelerated and real time stability studies data of three batches as per zone IV-
A conditions upto claimed shelf life.
Name and address of M/s O.L. Kar-AgroZooVet -Service.
manufacturer PC 272B Lenina (Heriyiv Maydanu) St., Shargorod, Vinnytsia
Region, Ukraine, 23500
Name and address of marketing M/s O.L. Kar-AgroZooVet-Service.
authorization holder PC 272B Lenina (Heriyiv Maydanu) St., Shargorod, Vinnytsia
Name of exporting country Ukraine
Brand Name +Dosage Form + Mastiline Intramammary syringe tube for livestock
Strength
Composition Each 1gm Contains:
Cloxacillin Sodium Salt…2000 mg
Amoxicillin Trihydrate…750mg
Glycerin…200mg
Sodium Carboxymethyl Cellulose…140mg
Benzil Alcohol…500mg
Distilled Water…9335mg
Shelf life 2 years
Pack size 5gm syringe tube
Detail of certificates attached  Scanned copy of FSC No. PK00500S 30/1 dated 29-01-2020
 Scanned copy of GMP certificate 602-1121-16/3654 of 25-05-
2018, certified by the state service of Ukraine on Food safety
and Consumer protection Ukraine.
 Scanned copy of Distribution agreement between PLH and the
applicant dated 01-12-2019.
 Provide original legalized valid FSC, since the already
submitted FSC is expired even upon submission.
 Provide original legalized valid GMP certificate, since the
already submitted is scanned copy
PLH and Applicant since the already submitted is scanned
copy.
 original legalized valid FSC
 original legalized valid relevant GMP certificate
 06 month accelerated and real time stability studies data of three batches as per zone IV-
A conditions upto claimed shelf life.
Name and address of M/s O.L. Kar-AgroZooVet -Service.
manufacturer PC 272B Lenina (Heriyiv Maydanu) St., Shargorod, Vinnytsia
Name and address of marketing M/s O.L. Kar-AgroZooVet-Service.
authorization holder PC 272B Lenina (Heriyiv Maydanu) St., Shargorod, Vinnytsia
Name of exporting country Ukraine
Brand Name +Dosage Form + Mastilong Forte Combined antimicrobial Intramammary syringe
Strength tube for livestock
Composition 1 Syringe (8g) Tube Contains:
Tetracycline HCl…200mg
Bacitracin…200 IU
Prednisolone…10mg
Pharmacological Group Antibiotic/ steroid
Shelf life 2 years
Pack size 8gm syringe tube
Detail of certificates attached Scanned copy of FSC No. PK00500S 28/1 dated 29-01-2020
 Scanned copy of GMP certificate 602-1121-16/3654 of 25-05-
2018, certified by the state service of Ukraine on Food safety
and Consumer protection Ukraine.
 Scanned copy of Distribution agreement between PLH and the
applicant dated 01-12-2019.
X
 Provide original legalized valid FSC, since the already
submitted FSC is expired even upon submission.
 Provide original legalized valid GMP certificate, since the
scope of already submitted GMP does not cover hormones
PLH and Applicant since the already submitted is scanned
copy.
685. Name and address of Applicant M/s U.M. Enterprises, Plot No. 12, Sector 15, Korangi Industrial
Area, Karachi-74900, Pakistan
Detail of Drug Sale License Name: M/s U.M. Enterprises,
Address: Plot No. 12, Sector 15, Korangi Industrial Area,
Karachi-74900, Pakistan
Date of issuance: 21-03-2023.
Name and address of M/s Guangzhou Haicheng Pharmaceutical Co., Ltd.
manufacturer 311-312 A Yangming Nongzi Market, No.180-1 Tianyuan Road,
Tianhe Area, Ghuangzhou China
Name and address of marketing M/s Guangzhou Haicheng Pharmaceutical Co., Ltd.
authorization holder 311-312 A Yangming Nongzi Market, No.180-1 Tianyuan Road,
Tianhe Area, Ghuangzhou China
Fee including differential fee Rs : 1,50,000 Dated 05-10-2021 (slip No. 6505525117)
Brand Name +Dosage Form + Halofuginone Hydrobromide 0.6% Powder
Strength
Halofuginone Hydrobromide…6mg
Shelf life 02 Years
Demanded Price N/A
Pack size Not demanded
Detail of certificates attached  Original Legalized FSC dated 21-02-2021 issued by the
Guangdong institute for Veterinary drug and feedstuffs
inspection of Peoples Republic of China confirms Free sale
status of applied product in country of origin.
 Original Legalized GMP certificate dated 05-09-2020 issued
by the Ministry of Agriculture Peoples Republic of China
confirms GMP status of the manufacturer
 Original Legalized LOA dated 12-03-2021
Validity: 1 year
Shortcomings:
PLH and Applicant since the already submitted is expired now
but valid upon submission.
namely; (i) Name of drug is missing. Submit label in
accordance with The Drugs (Labeling and Packing) Rules,
1986.
686. Name and address of Applicant M/s Ghazi Brothers, Ghazi House, D-35, K.D.A Scheme No.1,
Miran Muhammad Shah Road, Karachi-75350, Pakistan
Detail of Drug Sale License Name: M/s Ghazi Brothers
Address: D-35, K.D.A Scheme No.1, Miran Muhammad Shah
Road, Karachi
Validity: 29-06-2023.
Name and address of M/s Hebei Yuanzheng Pharmaceutical Co., Ltd. China
manufacturer No.16 Liuyuan Road, Chang’ an District, Shijiazhuang City Hebei
Province.
Name and address of marketing M/s Hebei Yuanzheng Pharmaceutical Co., Ltd. China
authorization holder No.16 Liuyuan Road, Chang’ an District, Shijiazhuang City Hebei
Province.
Name of exporting country Peoples Rpublic of China
Fee including differential fee Rs : 1,00,000 Dated 28-09-2016
Brand Name +Dosage Form + Velenium Oral Solution
Strength
Vitamin E..........100mg
Sodium Selenite..........0.5mg
Pharmacological Group Vitamin and minerals
Shelf life 3 years
Me-too status Z-Selovit-E Ol Oral Liquid of M/s Zoic International, Lahore.
(Reg. No. 090663)
Detail of certificates attached  Legalized original COPP No. 2014 J.S.P.Z.W.M.Z. No. 8541
dated 17-10-2014 issued by Ministry of Agriculture of People’s
Republic of China confirms GMP status of the manufacturer
and free sale status of the applied product in exporting country.
 Legalized original LOA No. 2014 J.S.P.Z.W.M.Z. No. 8538
dated 17-10-2014
Shortcomings:
 Legalized original COPP sole agency/distribution
agreement/LOA since the already submitted is expired
following namely; (i) Name of drug is missing. Submit
label in accordance with The Drugs (Labeling and
Packing) Rules, 1986.
 valid legalized original CoPP
687. Name and address of Applicant M/s ZS Biotech,
Head office address: 50-C, Madina Block, Awan Town, Multan
Road, Lahore, Pakistan.
Warehouse address: 22-A, Hidayat Ullah Block, Mustafa Town,
Wahdat Road, District Lahore.
Detail of Drug Sale License Name: M/s ZS Biotech
Address: House No. 22-A, Hidayat Ullah Block, Mustafa Town,
Validity: 20-01-2024.
Name and address of M/s Better Pharma Co., Ltd., Betagro Tower (North Park), 323
manufacturer Vibhavadi Rangsit Road, Laksi, Bankok, 10210, Thailand
Name and address of marketing M/s Better Pharma Co., Ltd., Betagro Tower (North Park), 323
authorization holder Vibhavadi Rangsit Road, Laksi, Bankok, 10210, Thailand
Name of exporting country Thailand
with Master File Bearing Dy No. 17499 Having All Original
Legalised Documents
Brand Name +Dosage Form + Tylin Oral Powder
Strength
Tylosin as Tylosin Phosphate…100mg
Shelf life 2 years
Pack size 20Kg
Me-too status TYLOSIN-100 Powder of M/s. VETERINARY FARMS AIDS
SHEIKHPURA, 012981 1KG
Detail of certificates attached  Scanned copy of legalized FSC dated 28-05-2020 issued by the
Food and Drug Administration, Ministry of Public Health,
Thailand confirms free sale status of the product in country of
origin.
 Original legalized GMP certificate dated 28-11-2017 issued by
the Food and Drug Administration, Ministry of Public Health
Thailand confirms GMP status of the manufacturing site.
 Original legalized distribution agreement made on 01-12-2020
between the applicant and product license holder is provided.
studies data as per zone-IV-B conditions
Shortcomings:
 Submit legalized original valid FSC, since the already
submitted scanned copy is expired now but valid upon
submission.
 Submit legalized original valid GMP certificate since the
already submitted is expired now but valid upon
submission.
 legalized original valid FSC
 legalized original valid GMP certificate of the manufacturer
 Fee of Rs. 7500/- for correction/pre-approval change in finished product specifications as
Validity: 20-01-2024.
Name and address of M/s Farmabase Saude Animal Ltda., Av. Emilio Marconato, n
manufacturer 1000-Jaguariuna, Brazil
Name and address of marketing M/s Farmabase Saude Animal Ltda., Av. Emilio Marconato, n
authorization holder 1000- Jaguariuna, Brazil
Name of exporting country Brazil
Brand Name +Dosage Form + Farmaxilin 50 Powder
Strength
Amoxicillin (as Amoxicillin trihydrate)…500mg
Shelf life 2 years
Pack size 200gram sachet
Me-too status Amocillin 50% Water Soluble Powder of M/s Eterna Pharma
(Pvt) Ltd., Mirpur, AJK (Reg. No.112326)
Detail of certificates attached  Scanned copy of FSC dated 02-05-2018 issued by the Ministry
of Agriculture, Livestock, and Food Supply Livestock
confirms free sale status of the product in country of origin.
 Scanned copy of GMP Certificate dated 18-01-2023 issed by
Ministry of Agriculture life stock and supply, Brazil. (Does
not cover the scope of penicillin production line.)
 Copy of legalized distribution agreement made on 13-06-2018
Validity: 36 Months
studies data as per zone-IV-A conditions
Shortcomings:
submission.
 Submit legalized original valid relevant GMP certificate;
covering the scope of penicillin production lines.
 Confirmation of dedicated/self contained manufacturing
facility
 Provide notarized original valid distribution agreement
between product license holder and distributor, since
already submitted photocopy is expired now but valid
upon submission.
 legalized original valid GMP certificate covering the scope of penicillin production lines.
 confirmation of dedicated/self contained manufacturing facility
Validity: 20-01-2024.
Name and address of M/s Farmabase Saude Animal Ltda., Av. Emilio Marconato, n
manufacturer 1000-Jaguariuna, Brazil
Name and address of marketing M/s Farmabase Saude Animal Ltda., Av. Emilio Marconato, n
authorization holder 1000- Jaguariuna, Brazil
Name of exporting country Brazil
Brand Name +Dosage Form + Lincofarm TR Oral Powder
Strength
Lincomycin (hydrochloride)…440mg
Shelf life 2 years
Pack size 200gram sachet
Detail of certificates attached  Photocopy of FSC dated 05-10-2020 issued by the Ministry of
Agriculture, Livestock, and Food Supply Livestock confirms
free sale status of the product in country of origin.
 Scanned copy of GMP Certificate dated 18-01-2023 issed by
Ministry of Agriculture life stock and supply, Brazil.
 Copy of legalized distribution agreement made on 13-06-2018
Validity: 36 Months
Shortcomings:
submitted is scanned copy.
 Submit legalized original valid GMP certificate.
 Provide notarized original valid distribution agreement
between product license holder and distributor, since
already submitted photocopy is expired now but valid
upon submission.
 legalized original valid GMP certificate.
alongwith registration number, brand name and name of firm
690. Name and address of Applicant M/s Brand Station, House No. 89-A2, Wapda Town, Extension,
Iqbal Town Lahore.
Detail of Drug Sale License Not provided
Name and address of M/s Asia Animal Pharmaceutical Co., Ltd.
manufacturer No. 130, 1A Highway, Ba Lang Ward, Cai Rang District, Can Tho
City, Vietnam
Name and address of marketing M/s Asia Animal Pharmaceutical Co., Ltd.
authorization holder No. 130, 1A Highway, Ba Lang Ward, Cai Rang District, Can Tho
City, Vietnam
Name of exporting country Vietnam
Fee including differential fee Rs : 100,000 Dated 09-04-2021
Brand Name +Dosage Form + Para-Sone Water Soluble Powder
Strength
Paracetamol…45 mg
Prednisolone…0.1mg
Pharmacological Group NSAID/ Mucolytic/ Corticosteroid
Shelf life 03 Years
Pack size 1Kg
Detail of certificates attached  Copy of GMP certificate No. 16/17/GCN-GMP dated 01-08-
2017 issued by Department of Animal Health Ministry of
Agriculture and Rural Development Vietnam (scope does not
cover steroid manufacturing lines)
Validity: 5 Years
 Copy of Free sale certificate No. 618/2019/QLT-CFS dated 17-
06-2019 issued by Department of Animal Health Ministry of
Agriculture and Rural Development Vietnam
Validity: 2 Years
 Copy of agency agreement concluded on 17-10-2020 between
the applicant and PLH
 Provide valid legalized original letter of authorization (LOA)/
sole agency certificate and Free sale certificate (FSC), since
already submitted are copies.
 Provide valid legalized original relevant GMP certificate since
the scope of already submitted copy does not cover steroid
manufacturing lines.
 Provide 06 month accelerated and 36-month real time stability
studies data of three batches at zone IV-A/IV-B conditions
upto claimed shelf life.
DRAP (generic / me-too status) alongwith registration number,
691. Name and address of Applicant M/s Brand Station, House No. 89-A2, Wapda Town, Extension,
Iqbal Town Lahore.
Detail of Drug Sale License Not provided
Name and address of M/s Asia Animal Pharmaceutical Co., Ltd.
manufacturer No. 130, 1A Highway, Ba Lang Ward, Cai Rang District, Can Tho
City, Vietnam
Name and address of marketing M/s Asia Animal Pharmaceutical Co., Ltd.
authorization holder No. 130, 1A Highway, Ba Lang Ward, Cai Rang District, Can Tho
City, Vietnam
Brand Name +Dosage Form + Doxycyclin Soluble Powder
Strength
Composition Each 100g Contains:
Doxycycline Hyclate…80g
Shelf life 03 Years
Pack size 100gm
Me-too status Eter Doxycycline -80 Water Soluble Powder of M/s Eterna
Pharma (Pvt) Ltd., Mirpur, AJK. (Reg. No. 109849)
Detail of certificates attached  Copy of GMP certificate No. 16/17/GCN-GMP dated 01-08-
2017 issued by Department of Animal Health Ministry of
Agriculture and Rural Development Vietnam
Validity: 5 Years
 Copy of agency agreement concluded on 17-10-2020 between
the applicant and PLH
Shortcomings:
sole agency certificate since already submitted is copy.
 Provide valid legalized original Free sale certificate (FSC)
 Provide valid legalized original GMP certificate since already
submitted copy is expired now but valid upon submission.
 valid legalized original FSC
692. Name and address of Applicant M/s Al-Asar Enterprises (Pakistan), Gulshan E Ghulab Colony,
Behind Abdullah Heart Care, Pull Wasil Suraj, Miani Road,
District Multan, Pakistan
Detail of Drug Sale License Name: M/s Al-Asar Enterprises
Address: Gulshan E Ghulab Colony, Behind Abdullah Heart
Care, Pull Wasil Suraj, Miani Road, District Multan, Pakistan
Validity: 05-08-2027.
Status: License to sell drugs as a Distributor (Form No.11).
Name and address of M/s Vemedim Veterinary Drugs and Probiotics Co. Ltd (Vemedim
manufacturer Animal Health), Song Hau Industrial Zone, Dong Phu Commune,
Chau Thanh District, Hau Giang Province, Viet Nam.
Name and address of marketing M/s Vemedim Veterinary Drugs and Probiotics Co. Ltd (Vemedim
authorization holder Animal Health), Song Hau Industrial Zone, Dong Phu Commune,
Chau Thanh District, Hau Giang Province, Viet Nam.
Brand Name +Dosage Form + Tylofos Powder for Oral Solution
Strength
Composition Each gm contains:
Fosfomycin Sodium…200mg
Shelf life 2 years
Pack size 1Kg
Detail of certificates attached  Original legalized FSC Ref. No. 607/2020/QLT-CFS dated 30-
06-2020 issued by Department of Animal Health of Vietnam
confirming the free sale status in exporting country
Validity: 2years
 Scanned copy of GMP certificate No. 32/18/GCN-GMP dated
16-10-2018 issued by Department of Animal Health Ministry
of Agriculture and Rural Development Vietnam
 Scanned copy of legalized distribution agreement No.
01/VEMEDIM.ALASAR.2020 dated 24-03-2020 between
applicant and MAH.
studies data as per zone-IV-B conditions
Shortcomings:
 Provide original legalized valid GMP certificate and Power of
attorney/sole distributor agreement since the already submitted
are scanned copies.
 Provide original legalized valid Free Sale certificate since the
already submitted FSC is expired now but valid upon
submission.
 valid legalized original FSC
693. Name and address of Applicant M/s Orient Traders International, CM-10, Block A, Kazimabad,
Model Colony, Karachi, Pakistan
Detail of Drug Sale License Name: M/s Orient Traders International
Address: CM-10, Block A, Kazimabad, Model Colony, Karachi
Status: Drug License By Way of Wholesale (Form No.07).
Name and address of M/s Laboratoires Biove, 3 Rue de, Lorraine, F-62510 Arques,
manufacturer France
(Manufacturing, Quality control and primary packaging)
M/s V.M.D. N. V. Hoge Mauw 900 B-2370 Arendonk-Belgium
(Batch release and secondary packaging in EU)
Name and address of marketing M/s V.M.D. N. V. Hoge Mauw 900 B-2370 Arendonk-Belgium
Name of exporting country Belgium
Brand Name +Dosage Form + Tulinovet 100mg/ml Injectable Solution
Strength
Tulathromycin…100mg
Finished Product Specification Ph. Eur
Shelf life 2 years
Demanded Price N/A
Pack size 100ml vial
Me-too status Thrust Injection (100ml) of M/s Elko Organization (Pvt.) Ltd,
Detail of certificates attached  Original legalized Certificate of Pharmaceutical Product
Certificate No. 02/21/154788 Issued on 18/02/2021, Certified
by European Medicines Agency, Domenico Scarlattilaan 6,
1083 HS Amsterdam, The Netherlands. The CoPP confirms
free sale status of the product in exporting country as well as
GMP status of the manufacturing site.
 Original notarized declaration of sole agent dated 12-06-2023,
validity 3 years, is given.
Remarks of the Evaluator X  06 months accelerated and 24 months long term stability
studies data has been submitted as per zone-IV-A conditions.
 The official monograph of the applied formulation does not
exist in any available edition of pharmacopoeia.
Decision: Approved. Fim shall submit fee of Rs. 7500/- for correction/pre-approval change in
Detail of Drug Sale License Name: M/s Orion Group,
Address: 97 Commercial area Usman Block, Muslim Town No.1,
Sargodha Road, Faisalabad
Validity: 22-01-2023.
Name and address of M/s S.P. Veterinaria, S.A.
manufacturer Crta. Reus-Vinyols, Km. 4.1 P.O Box 60, 43330, RIUDOMS
(Tarragona) Spain.
Name and address of marketing M/s Cenavisa S.A.
authorization holder Cami Pedra Estela, s/n 43205 Reus (Tarragona) Spain.
Brand Name +Dosage Form + 15-Amox Injectable Suspension
Strength
Amoxicillin (Trihydrate)…150mg
Shelf life 2 years
Pack size 100ml
Me-too status Amocillin 15% Injection (100ml) of M/s Eterna Pharma (Pvt)
Ltd., Mirpur, AJK (Reg. No. 113596)
Detail of certificates attached  Originally legalized COPP No. 2021/203 dated 04-03-2021
issued by Spanish Agency for Medicines and Health Products
confirms free sale status of the product in exporting.
 Originally legalized GMP certificate No. ES/103HV/18**
dated 09-06-2020 issued by the Spanish Agency for Medicines
and Health Products. (scope covers β- lactam antibiotics
production lines)
 Originally legalized distribution agreement dated 05-06-2019
between the manufacturer and the applicant
Remarks of the Evaluator X Provided 06months accelerated and 12months real time stability
studies data of three batches as per zone IV-A conditions.
Shortcomings:
 Provide Original legalized valid relevant GMP certificate,
covering the scope of penicillin production lines; since the
already submitted copy of GMP certificate is expired now but
valid upon submission.
 Provide Original notarized valid distribution agreement/ power
of attorney between the Marketing Authorization Holder and
the applicant
 Provide real time stability studies data of three batches as per
zone IV-A conditions upto claimed shelf life.
 valid legalized original GMP certificate covering the scope of penicillin production lines
 real time stability studies data of three batches as per zone IV-A conditions upto claimed shelf
life
 The Board further decided that the applicant shall submit the response within 1 month after
695. Name and address of Applicant M/s Tarobina Corporation, 226-Ahmad Block, New Garden Town,
Lahore, Pakistan
Detail of Drug Sale License Name: M/s Tarobina Corporation,
Address: 226-Ahmad Block, New Garden Town, Lahore,
Pakistan
Validity: 15-03-2028.
Name and address of M/s Alke Saglik Urunleri San.Tic.A.S. Merkez Organize Sanayi
manufacturer Bolgesic2. Kisim 10. Cadde No:7 Tokat Turkey
Name and address of marketing M/s Alke Saglik Urunleri San.Tic.A.S. Sahrayicedid Mah. Batman
authorization holder Sok, Royal Plaza No: 18/6 Kadikoy-Istanbul-Turkey
Fee including differential fee Rs.150,000/- Dated 22-06-2021
Brand Name +Dosage Form + Actimisin AK Oral Solution
Strength
Tilmicosin Phosphate…250mg
Shelf life 24months
Pack size 480ml
Me-too status Kptil Oral 25% Oral Liquid of M/s Krypton Pharma (Pvt) Ltd.,
Detail of certificates attached  Originally legalized COPP No. 09.11.2006-17/004 dated 24-
11-2020 issued by General directorate of Food and Control,
Ministry of Agriculture and Forestry Republic of Turkey
and GMP status of the manufacturing site.
 Scanned copy of legalized GMP certificate No.
GMP/TR/V/Yi/S0149/2019 dated 21-05-2019 (Original in
Fenerol 30% oral solution) issued by General directorate of
Food and Control, Ministry of Food, Agriculture and Livestock
Republic of Turkey.
 Copy of legalized distribution agreement (Original in Fenerol
30% oral solution) dated 28-09-2020 between the MAH and
the applicant.
Validity: 5 years
 Initially the firm has applied for Tilmicosin
Phosphate…250mg/ml on Form 5A while Tilmicosin as
Phosphate…250mg/ml in COPP and FSC is mentioned. Upon
clarification of applied formulation the firm has revised
formulation to below mentioned label claim as per COPP and
FSC. However, the fim has not submitted fee for revision of
label claim.
Shortcomings:
 Provide original legalized valid COPP and GMP certificate
since the already submitted are expired now but valid upon
submission.
Each ml contains:
Tilmicosin as Phosphate…250mg
Firm shall submit following before issuance of registration letter:
 original legalized valid COPP and GMP certificate
 Fee Rs. 150,000/- for correction/pre-approval change in formulation (salt form) and finished
product specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Lahore, Pakistan
Pakistan
Validity: 15-03-2028.
Brand Name +Dosage Form + Actimisin Solution for Injection
Strength
Tilmicosin …300mg
Shelf life 24months
Pack size 100ml
Me-too status Micobak Injection (100ml) of M/s Attabak Pharmaceuticals,
Republic of Turkey.
the applicant.
Validity: 5 years
 The official monograph of the applied formulation exists in
USP
Shortcomings:
 Provide original legalized valid GMP certificate since the
already submitted is expired now but valid upon submission.
Decision: Approved as per policy for inspection of manufacturer abroad. Firm shall submit Fee
Rs. 7,500/- for correction/pre-approval change in finished product specifications as per
notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021 before the issuance of registration
letter.
Lahore, Pakistan
Pakistan
Validity: 15-03-2028.
Brand Name +Dosage Form + Ultramec 2% Solution for Injection 50ml
Strength
Ivermectin…20mg
Pharmacological Group Endoctosit
Pack size 50ml
Me-too status Ivermec 2% Injection (50ml) of M/s Grand Pharma (Pvt) Ltd.,
Rawat. (Reg. No. 111547)
Republic of Turkey.
the applicant.
Validity: 5 years
Shortcomings:
letter.
Lahore, Pakistan
Pakistan
Validity: 15-03-2028.
Brand Name +Dosage Form + Fenerol Solution for Injection (100ml)
Strength
Florfenicol…300mg
Pack size 100ml
Me-too status Florfenicen Injectable Solution (100ml) of M/s Mustafa Brothers,
Republic of Turkey.
the applicant.
Validity: 5 years
Shortcomings:
submission.
letter.
Lahore, Pakistan
Pakistan
Validity: 15-03-2028.
Brand Name +Dosage Form + Enrolen 10% Solution for Injection (100ml)
Strength
Pack size 100ml
Me-too status Enro-Pro 10 Injection (100ml) of M/s Eterna Pharma (Pvt) Ltd.,
Republic of Turkey.
the applicant.
Validity: 5 years
Shortcomings:
submission.
Decision: Approved as per policy for inspection of manufacturer abroad. Firm shall submit
following before issuance of registration letter:
 Original legalized valid COPP.
 Fee Rs. 7,500/- for correction/pre-approval change in finished product specifications as per
Lahore, Pakistan
Pakistan
Validity: 15-03-2028.
Brand Name +Dosage Form + Enrolen 20% Oral Solution
Strength
Pack size 1000ml
Me-too status Bovicin-20 Oral Solution of M/s Eterna Pharma (Pvt) Ltd., Mirpur,
AJK (Reg. No. 112149)
Republic of Turkey.
the applicant.
Validity: 5 years
X
Remarks of the Evaluator Provided 06months accelerated and 24months real time stability
Shortcomings:
letter.
Lahore, Pakistan
Pakistan
Validity: 15-03-2028.
Brand Name +Dosage Form + Gantapan 15% Solution for Injection
Strength
Gentamicin as Sulphate…150mg
Pack size 100ml
Me-too status Gantasin-15% Injection (100ml) of M/s Univet Pharmaceuticals,
Republic of Turkey.
the applicant.
Validity: 5 years
Shortcomings:
letter.
Lahore, Pakistan
Pakistan
Validity: 15-03-2028.
Brand Name +Dosage Form + Megasil LA Suspension for Injection
Strength
Amoxicillin as (Trihydrate)…150mg
Pack size 100ml
Me-too status Amocillin 15% Injection (100ml) of M/s Eterna Pharma (Pvt) Ltd.,
Republic of Turkey.
the applicant.
Validity: 5 years
Shortcomings:
 Provide original legalized valid relevant GMP certificate since
the already submitted is expired now but valid upon
submission.
 Confirmation of dedicated penicillin manufacturing facility.

 Original legalized valid relevant GMP certificate
Lahore, Pakistan
Pakistan
Validity: 15-03-2028.
Brand Name +Dosage Form + Neozid Powder for Oral Solution
Strength
Neomycin as Sulphate…500mg
Pack size 1000gm
Republic of Turkey.
the applicant.
Validity: 5 years
Remarks of the Evaluator X Provided 06-month accelerated and 48-month real time stability
Shortcomings:
 Provide original legalized valid CoPP and GMP certificate
submission.
 Provide real time stability studies data of three batches as per
zone IV-A conditions upto claimed shelf life.
 Original legalized valid COPP and relevant GMP certificate
 Real time stability studies data of three batches as per zone IV-A conditions upto claimed
shelf life
Lahore, Pakistan
Pakistan
Validity: 15-03-2028.
Brand Name +Dosage Form + Buparvon Solution for Injection
Strength
Buparvaquone…50mg
Pharmacological Group Antiprotozoal
Pack size 50ml
Me-too status Eter Bupra Injection (50ml) of M/s Eterna Pharma (Pvt) Ltd.,
Republic of Turkey.
the applicant.
Validity: 5 years
Shortcomings:
 Original legalized valid GMP certificate
 Fee Rs. 7,500/- for correction/pre-approval change in finished product specifications as per
Lahore, Pakistan
Pakistan
Validity: 15-03-2028.
Brand Name +Dosage Form + Fenerol 30% Oral Solution
Strength
Florfenicol…300mg
Pack size 1000ml
 Original legalized GMP certificate No.
GMP/TR/V/Yi/S0149/2019 dated 21-05-2019 issued by
General directorate of Food and Control, Ministry of Food,
Agriculture and Livestock Republic of Turkey.
 Original legalized distribution agreement dated 28-09-2020
between the MAH and the applicant.
Validity: 5 years
Shortcomings:
 Original legalized valid GMP certificate
706. Name and address of Applicant M/s QAS International, 42-A, 1st Floor, Olivia Plaza, Commercial
Area, Block A, Phase 2, City Housing, Gujranwala
Detail of Drug Sale License Legible copy not provided
Name and address of M/s Super's Diana S.L. CTRA C.17, 17 KM, 08150 Parets Del
manufacturer Valles, Barcelona, Spain
Name and address of marketing M/s Super's Diana S.L. CTRA C.17, 17 KM, 08150 Parets Del
authorization holder Valles, Barcelona, Spain
Brand Name +Dosage Form + Amoxiqas Oral Powder for Use in Drinking Water
Strength
Amoxicillin Trihydrate 700mg Eq. to Amoxicillin…610mg
Finished Product Specification Ph Eur specifications
Pack size 1Kg
International availability CIMAvet, Spain approved with brand name AMOXIDIAN
agency of Medicines and Health products, Spain confirming
of the manufacturer
 Copy of legalized sole distributor agreement dated 28-02-2019
between applicant and MAH.
Impurity E rises at 3rd and 6th month time point in accelerated
stability study.
Shortcomings:
 Provide legible copy of valid DSL
 Provide original notarized valid Power of attorney/sole
distributor agreement since the already submitted is
photocopy.
 legible copy of valid DSL
 original notarized valid Power of attorney/sole distributor agreement
 confirmation of dedicated penicillin manufacturing facility.
 accelerated and real time stability studies data of three batches as per zone IV-A conditions
upto claimed shelf life
707. Name and address of Applicant M/s QAS International, 42-A, 1st Floor, Olivia Plaza, Commercial
Area, Block A, Phase 2, City Housing, Gujranwala
Detail of Drug Sale License Legible copy not provided
Name and address of M/s Super's Diana S.L. CTRA C.17, 17 KM, 08150 Parets Del
manufacturer Valles, Barcelona, Spain
Name and address of marketing M/s Super's Diana S.L. CTRA C.17, 17 KM, 08150 Parets Del
authorization holder Valles, Barcelona, Spain
Brand Name +Dosage Form + Megluvet Solution for Injection
Strength
Flunixin (Meglumine)…50mg
Pharmacological Group Anti-inflammatory non-steroidal
Pack size 100ml
Rawat, Rawalpindi. (Reg. No. 112255)
agency of Medicines and Health products, Spain confirming
of the manufacturer
 Copy of sole distributor agreement dated 21-01-2021 between
applicant and MAH for the applied product.
Shortcomings:
 Provide legible copy of valid DSL
 Provide original notarized valid Power of attorney/sole
distributor agreement since the already submitted is
photocopy.
 legible copy of valid DSL
 original notarized/appostile valid Power of attorney/sole distributor agreement
b. Deferred cases
i. Veterinary
708. Name and address of Applicant M/s Huzaifa International, Commercial Area, Aziz Bhatti
Town, Sargodha, Pakistan.
Detail of Drug Sale License Name: M/s Huzaifa International
Address: Commercial Area, Aziz Bhatti Town, Sargodha.
Name and address of manufacturer M/s Komipharm International Co., Ltd.
17 Gyeongje-ro, Siheung-Si, Gyeonggi-Do, South Korea
Name and address of marketing M/s Komipharm International Co., Ltd.
authorization holder 17 Gyeongje-ro, Siheung-Si, Gyeonggi-Do, South Korea
Name of exporting country The Republic of Korea (South Korea)

Brand Name +Dosage Form + Komidocarb Injection
Strength
Imidocarb Dipropionate…120mg
Shelf life 3 years
Pack size 10ml, 20ml, 50ml, 100ml
Me-too status Durazol Injection (10ml, 20ml, 50ml, 100ml) of M/s Mylab
(Pvt) Ltd. Khanqah Sharif, Bahawalpur (Reg. No. 078204)
Detail of certificates attached  Originally legalized FSC certificate No. M2010391 issued
by the Animal and plant Quarantine Agency, republic of
Korea DOES NOT CONFIRM free sale status of the
product in exporting country.
 Original legalized GMP certificate dated 06-04-2020 issued
by the Animal and plant Quarantine Agency, republic of
Korea
 Scanned copy of authorization letter dated 06-10-2020
between PLH and Applicant
X
Remarks of the Evaluator Provided 06months accelerated and 36months real time
Shortcomings:
 Provide originally legalized FSC since the already
submitted FSC states that the applied product is registered
and permitted to be freely sold in overseas markets.
following namely; (i) dosage; and (ii) Instruction is
missing. Submit label in accordance with The Drugs
(Labeling and Packing) Rules, 1986.
Decision of 326th meeting: Deferred for following
 valid copy of DSL
 originally legalized Free Sale Certificate
Updated status:
The firm has submitted the following:
i. Copy of DSL valid till 20-11-2023.
ii. Original legalized FSC # M2301188 dated 18-05-2023 issued by the Animal and plant
Quarantine Agency, republic of Korea confirms the free sale status in country of origin.
iii. Label in accordance with The Drugs (Labeling and Packing) Rules, 1986 fro pack size of
10ml.
Decision: Approved with 10ml pack size. Firm shall submit fee Rs. 7500/- for correction/pre-
approval change in finished product specifications as per notification No.F.7-11/2012-
B&A/DRAP dated 07-05-2021 before issuance of registration letter.
709. Name and address of Applicant M/s Vetynex Pharma, 1.5 Km, Defense Road, Off Ferozpur
Road, Kahna Nau-Lahore, Pakistan.
Detail of Drug Sale License Name: M/s Vetynex Pharma,
Address: 1.5 Km, Defense Road, Off Ferozpur Road, Kahna
Nau-Lahore
Validity: 16-12-2023.
Status: License to sell Drugs as a Distributor (Form No.11).
Name and address of manufacturer M/s APA United Nano Technology Co., Ltd.
Lot C2-4, VL3 Street, Vinh Loc 2 Industrial Park, Voi La
Hamlet, Long Hiep Commune, Ben Luc District, Long An
Province, Vietnam
Name and address of marketing M/s APA United Nano Technology Co., Ltd.
authorization holder Lot C2-4, Vl3 Street, Vinh Loc 2 Industrial Park, Voi La
Province, Vietnam
Brand Name +Dosage Form + APA Ceftiofur S Suspension for Injection
Strength
Ceftiofur HCl…5gm
Shelf life 02 Years
Pack size 100ml
Me-too status Ceptifi Veterinary Injectable Suspension (100ml) of M/s Al-
Asar Enterprises, Multan. (Reg. No. 094479)
Detail of certificates attached  Originally, Legalized FSC No. 1211/2021/QLT-CFS dated
22-11-2021 issued by Department of Animal Health,
Ministry of Agriculture and Rural Development, Socialist
Republic of Vietnam confirms Free sale status of applied
product in country of origin.
Validity: 02 years
 Scanned copy of Legalized GMP certificate certified by
Department of Animal Health, Ministry of Agriculture and
Rural Development, Socialist Republic of Vietnam
confirms the scope of manufacturing operations of β-
Lactam antibiotics (solution and suspension for
injection)
Issued on: 02-06-2017
Validity: 5 years
 Photocopy of legalized distribution agreement made on 02-
12-2019 between M/s Vetynex Pharma, 1.5 Km, Defense
Road, Off Ferozpur Road, Kahna Nau-Lahore and M/s
APA United Nano Technology Co., Ltd., Lot C2-4, VL3
Street, Vinh Loc 2 Industrial Park, Voi La Hamlet, Long
Hiep Commune, Ben Luc District, Long An Province,
Vietnam.
Remarks of the Evaluator X  Provided 06 month accelerated and 24months real time
stability studies data of three batches at zone IV-B
conditions.
Shortcomings:
 Provide original valid Legalized GMP since already
submission.
th
Decision of 326 meeting: Deferred for following
 original valid legalized relevant GMP certificate
Updated status:
i. Firm has submitted that a letter of confirmation form APA UNITED
NANOTECHNOLOGY CO., LTD, stating that in Vietnam, the Ministry of Agriculture
& Rural Development, Department of Animals Health only certify two production lines
of Beta-Lactam and Non Beta-Lactam. Their product belongs to Beta-Lactam line.
ii. Firm has also submitted that AL-ASAR ENTERPRISES (PAKISTAN) MULTAN is
distributor of VEMEDIM ANIMAL HEALTH VIETNAM, they register one of
suspension product namely VIME-AMOX 15% LA having DRAP Registration No.
094478 and Cepti Veterinary Injectable Suspension Reg. No. 094479 with same GMP. It
is therefore requested to please consider our case to register our products.
Decision: Deferred for clarification rearding the international practices for manufacturing of
beta lactam anitibiotics.
Nau-Lahore
Validity: 16-12-2023.
Province, Vietnam
Province, Vietnam
Brand Name +Dosage Form + APA Amox Gen S Suspension
Strength
Amoxicillin Trihydrate…15gm
Gentamycin Sulphate…4gm
Shelf life 02 Years
Pack size 100ml
Me-too status Pro-Mox Injection (100ml) of M/s Prix Pharmaceutica,
Lahore. (Reg. No.102203)
Detail of certificates attached  Originally Legalized FSC No. 1214/2021/QLT-CFS dated
Validity: 02 years
Lactam antibiotics (solution and suspension for injection)
Issued on: 02-06-2017
Validity: 5 years
Vietnam.
Remarks of the Evaluator X  Provided 06 month accelerated and 24months real time
conditions.
Shortcomings:
submission.
Updated status:
Nau-Lahore
Validity: 16-12-2023.
Province, Vietnam
Province, Vietnam
Brand Name +Dosage Form + APA Clorprostinex Injection
Strength
Cloprostenol Sodium 26.3mg Eq. To Cloprostenol…25mg
Pharmacological Group Prostaglandin
Shelf life 02 Years
Pack size 20ml
Me-too status Ovuprost Injection (20ml) of M/s Ghazi Brothers, Karachi.
(Reg. No.099427)
Detail of certificates attached  Originally Legalized FSC No. 459/2020/QLT-CFS dated
Validity: 02 years
 Scanned copy of legalized GMP certificate certified by
Rural Development, Socialist Republic of Vietnam; its
scope does not cover manufacturing operations of
injectable Hormone.
Issued on: 02-06-2017
Validity: 5 years
 Photocopy of legalized distribution agreement made on 02-
APA United Nano Technology Co., Ltd. Lot C2-4, VL3
Vietnam.
 Provided 06 month accelerated and 24months real time
conditions.
Shortcomings:
 Provide legalized original valid relevant GMP certificate
since the scope of already submitted copy does not cover
manufacturing operations of injectable Hormone.
 Provide original valid Legalized FSC since already
submitted is expired now but valid upon submission
th
Decision of 326 meeting: Deferred for following
 original valid Legalized FSC
Updated status:
of Beta-Lactam and Non Beta-Lactam. Their product belongs to Non Beta-Lactam line.
Decision: Deferred for following
 Clarification rearding the international practices for manufacturing of beta lactam
anitibiotics.
 Valid Legalized FSC and GMP certficate
Nau-Lahore
Validity: 16-12-2023.
Province, Vietnam
Province, Vietnam
Brand Name +Dosage Form + APA Amox 15S Suspension
Strength
Amoxicillin Trihydrate…15gm
Shelf life 02 Years
Pack size 100ml
Me-too status Sinomox LA Suspension for Injection (100ml) of M/s Ghazi
Brothers, Karachi. (Reg. No. 106781)
Detail of certificates attached  Originally Legalized FSC No. 1216/2021/QLT-CFS dated
Validity: 02 years
Lactam antibiotics (solution and suspension for injection)
Issued on: 02-06-2017
Validity: 5 years
Vietnam.
 Provided 06 month accelerated and 24months real time
conditions.
Shortcomings:
submission.
Updated status:
Agenda of Evaluator PEC-XI
Case No. 1: Registration applications of Human Drugs on form 5F (New DML):

M/s Pinnacle Biotech (Pvt.) Ltd. Plot No. FD-49-A8, FD-50-A8, FD-51-A8, Korangi Creek Industrial
Park, Karachi
The Central Licensing Board 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 three sections to M/s
Pinnacle Biotech (Pvt.) Ltd., Plot No. FD-49-A8, FD-50-A8, FD-51-A8, Korangi Creek Industrial Park,
Karachi under Drug Manufacturing License No. 000939 by way of Formulation vide approval letter No. F.
2-10/2011-Lic(Vol-I) dated 13th September 2021. The Drug Manufacturing License No. 000939 by way of
formulation is hereby issued w.e.f. 13-09-2021.
S No. Name of Sections
1. Tablet (General)
3. Sachet (General)
4. Research & Development Laboratory
Following applications have been submitted for registration by the firm.
713. Name, address of Applicant / Marketing M/s Pinnacle Biotech (Pvt.) Ltd. Plot No. FD-49-A8,
Authorization Holder FD-50-A8, FD-51-A8, Korangi Creek Industrial Park,
Karachi.
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
GMP status of the firm Firm has submitted copy of cGMP certificate issued
on 21-10-2022 based on inspection conducted on 21-
10-2022.
Evidence of approval of manufacturing facility New license granted vide letter No. F. 2-10/2011-
Lic(Vol-I) dated 13/09/2021.
Tablet (general), Capsule (general), Sachet (general)
and Research and Development Laboratory section is
approved.
☐ Export sale
Dy. No. and date of submission Form-5F Dy.No 2986 dated 01-02-2023
(Deposit slip#4595632206)
The proposed proprietary name / brand name Azijet 500mg Tablet
Pharmaceutical ingredient (API) per unit Azithromycin Dihydrate equivalent to
azithromycin…………………500mg
Pharmacotherapeutic Group of (API) Tablet
Pharmaceutical form of applied drug Macrolide Antibiotics
The status in reference regulatory authorities ZITHROMAX 500mg film-coated tablets, USFDA
Approved.
For generic drugs (me-too status) Zetro 500mg Tablet by M/s Getz Pharma
(Reg#53120)
Name and address of API manufacturer. M/s Huangshi Shixing Pharmaceutical Co., Ltd., No.
73 East Jinshan Road, Huangjinshan Development
Zone, Huangshi, Hubei, P.R. China
of manufacturing process and controls, specifications,
analytical procedures and its verifications, batch
Stability Studies of Drug Substance Firm has submitted stability study data as per zone IV-
(Conditions & duration of Stability studies) A.
Accelerated: 40°C ± 2°C / 75% ± 5%RH 6 months
Batches: C0802-201909002, C0802-201909001,
C0802-201909003
Module-III Drug Product: The firm has submitted detail of manufacturers,
specifications, analytical procedure and its
Dissolution Profile equivalence for their product against Azomax 500mg
tablet by M/s GSK Consumer Healthcare Pakistan
Limited (mfgr) / Novartis Pharma (MAH) by
performing quality tests (Identification, average
weight, disintegration time, uniformity of dosage
units, dissolution, assay)
CDP has been performed against the product Azomax
500mg tablet by M/s Sandoz in Phosphate buffer (pH
4.5), Phosphate buffer (pH 6.0) & Phosphate Buffer
(pH 7.5). The values for f2 are in the acceptable range.
Analytical method validation/verification of Firm has submitted method verification studies
product including Accuracy, precision (repeatability) and
Specificity.
Manufacturer of API M/s Huangshi Shixing Pharmaceutical Co., Ltd., No. 73 East Jinshan Road,
Huangjinshan Development Zone, Huangshi, Hubei, P.R. China
API Lot No. C0802-202111007
Description of Pack Alu-alu Blister strip packed in unit carton
Batch No. T-057 T-056 T-053
Batch Size 1500 Tab 1500 Tab 1500 Tab
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API The firm has submitted written confirmation for active
manufacturer issued by concerned regulatory substance exported to EU to M/s Huangshi Shixing
authority of country of origin. Pharmaceutical Co., Ltd., No. 73 East Jinshan Road,
Huangjinshan Development Zone, Huangshi, Hubei,
P.R. China issued by Hubei Medical Products
Administration valid upto 1st June 2025. The certificate
confirms that the manufacturing plant complies with
requirement of Chinese Good Manufacturing practices.
Firm has submitted copy of DML (E20200125) in

name of M/s Huangshi Shixing Pharmaceutical Co.,
Ltd., No. 73 East Jinshan Road, Huangjinshan
Development Zone, Huangshi, Hubei, P.R. China
issued by Hubei Drug Administration valid upto 28th
September 2025.
3. Documents for the procurement of API with approval Not submitted
from DRAP (in case of import).
4. Data of stability batches will be supported by attested Firm has submitted data of stability batches supported
respective documents like chromatograms, Raw data by attested respective documents like chromatograms,
sheets, COA, summary data sheets etc. Raw data sheets, COA, summary data sheets etc.
5. Compliance Record of HPLC software 21CFR & Not Submitted
and accelerated)
Remarks of Evaluator XI:
Section Observations Response
2.3.R.1  Provide copy of Batch Manufacturing Record Firm has submitted copy of Batch Manufacturing
(BMR) for all the batches of drug product for Record (BMR) for all the batches of drug product
which stability studies data is provided in for which stability studies data is provided in
Module 3 section 3.2.P.8.3> Module 3 section 3.2.P.8.3>
3.2.S.4  Justification is required for setting assay  The firm submitted that in specification and
specification of drug substance on “dried basis testing method Assay limits is 94.5% to 103.0%
instead of anhydrous basis” by drug product that is same as per USP monograph and
manufacturer with reference to mentioned in analytical raw data report and
recommendations of USP monograph. Certificate of Analysis. The firm submitted that
 Submitted analytical method verification rectification of dried basis has been made and
report declares the details for “Azithromycin Fees has been submitted against typographical
500mg tablets”. error having challan No. 888753469724 of
Rs.7500/-
 The firm submitted that Azijet is a suggested
brand name and Azithromycin is a generic. We
have performed the verification on Azijet
500mg tablet and there is no difference in
product “Azijet” and “Azithromycin”.
3.2.P.1  You have used dibasic phosphate anhydrous We have use Dicalcium phosphate anhydrous. It
in your formulation instead of dibasic calcium is same as dibasic calcium phosphate anhydrous
phosphate anhydrous clarify? having same (CAS NO: 7757-93-9), against
GRN: RM2122 COA of material is submitted
3.2.P.2  Submit the image/picture/snapshot of  Image/picture/ snap shot of
innovator /reference/comparator pack against innovator/reference/comparator pack is
which Pharmaceutical submitted.
equivalence/Comparative dissolution profile  The firm submitted that for stability testing, the
studies have been performed and shall reveal dissolution media pH 6.0 phosphate buffer is
the details of brand name, manufacturer, used that is recommended by USP. While for
batch# and expiry date of the innovator CDP 3 different pH dissolution media used that
/reference/comparator product is 0.1M phosphate buffer, pH 4.5, 0.1M
 Selection of dissolution media (phosphate phosphate buffer pH 6.0 and 0.1M phosphate
buffer pH 4.5, pH 6, pH 7.5) in CDP studies buffer pH 7.5. Reference of selection of this 3
shall be justified with reference to applicable pH is “Clinical Pharmacology and
guidelines biopharmaceutics review application number
 Clarification is required as the submitted 50-784”. CDP has been performed with
details show that the reference product against reference to this guideline.
which pharmaceutical equivalence and CDP  Pharmaceutical equivalence and CDP
studies is performed is from two different performed against same reference product that is
supplier Azomax 500mg tablet. Details are provided.
Azomax 500mg tablet
Manufactured for:
Novartis Pharma (Pakistan) Limited By
M/s GSK Consumer Healthcare Pakistan Limited
Jamshoro
Sandoz a Novartis Division
3.2.P.5  Justification is required for not mentioning the  The firm submitted that dissolution time is
time for dissolution test in finished product 30minutes and is mentioned in analytical testing
specifications as recommended by USP. method and it is now mentioned in specification
 Justification is required for not including the as well. Revised Specification and testing
test for uniformity of dosage unit in finished method is submitted.
product specification as recommended by  The firm submitted that uniformity of dosage
USP unit by weight variation already mentioned in
finished product specification and submitted
finished product specifications.
3.2.P.8  Documents for the procurement of API with  Firm has submitted copy of invoice dated 09-12-
approval from DRAP is not submitted 2021 for import of 04kg of Azithromycin
 Record of Digital data logger for temperature Dihydrate in name of M/s Pinnacle Biotech
and humidity monitoring of stability chambers (Pvt.) Ltd attested by AD (I&E) DRAP Karachi
(real time and accelerated) is not submitted dated 28-12-2021. Firm has also submitted copy
of form 6 dated 28-12-2021 for import of 04kg
of Azithromycin Dihydrate in name of M/s
Pinnacle Biotech (Pvt.) Ltd attested by AD
(I&E) DRAP Karachi dated 28-12-2021.
(real time and accelerated) is submitted.
Decision: Approved. Registration letter will be issued after submission of CDP studies in three physiological
medias (i.e. 0.1N HCl pH 1.2, Acetate Buffer pH 4.5 and Phosphate Buffer pH 6.8)
 Manufacturer will perform process validation of first three batches as per the commitment submitted in the
714. Name, address of Applicant / Marketing M/s Pinnacle Biotech (Pvt.) Ltd. Plot No. FD-49-A8,
Authorization Holder FD-50-A8, FD-51-A8, Korangi Creek Industrial Park,
Karachi.
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
GMP status of the firm Firm has submitted copy of cGMP certificate issued
on 21-10-2022 based on inspection conducted on 21-
10-2022.
Evidence of approval of manufacturing facility New license granted vide letter No. F. 2-10/2011-
Lic(Vol-I) dated 13/09/2021.
Tablet (general), Capsule (general), Sachet (general)
and Research and Development Laboratory section is
approved.
☐ Export sale
The proposed proprietary name / brand name Azijet 250mg capsule
Strength / concentration of drug of Active Each Capsule Contains:
Pharmaceutical ingredient (API) per unit Azithromycin Dihydrate …………………250mg
Pharmacotherapeutic Group of (API) Capsule
Pharmaceutical form of applied drug Macrolide Antibiotics
The status in reference regulatory authorities ZITHROMAX 250 mg Capsule, MHRA Approved.
For generic drugs (me-too status) Azomax 250mg Capsule by M/s AGP Limited
(Reg#112797)
Name and address of API manufacturer. M/s Huangshi Shixing Pharmaceutical Co., Ltd., No.
73 East Jinshan Road, Huangjinshan Development
Zone, Huangshi, Hubei, P.R. China
Stability Studies of Drug Substance Firm has submitted stability study data as per zone IV-
(Conditions & duration of Stability studies) A.
Batches: C0802-201909002, C0802-201909001,
C0802-201909003
Module-III Drug Product: The firm has submitted detail of manufacturers,
specifications, analytical procedure and its
Dissolution Profile equivalence for their product against Azomax 250mg
tablet by M/s GSK Consumer Healthcare Pakistan
Limited (mfgr) / Novartis Pharma (MAH) by
performing quality tests (Identification, average
weight, disintegration time, uniformity of dosage
units, dissolution, assay)
CDP has been performed against the product Azomax
250mg capsule by M/s Sandoz in Phosphate buffer
(pH 4.5), Phosphate buffer (pH 6.0) & Phosphate
Buffer (pH 7.5). The values for f2 are in the acceptable
range.
product including Accuracy, precision (repeatability) and
Specificity.
Manufacturer of API M/s Huangshi Shixing Pharmaceutical Co., Ltd., No. 73 East Jinshan Road,
Huangjinshan Development Zone, Huangshi, Hubei, P.R. China
API Lot No. C0802-202111007
Description of Pack Alu-alu Blister strip packed in unit carton
Batch No. T-050 T-060 T-061
Batch Size 1500 capsule 1500 capsule 1500 capsule
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API The firm has submitted written confirmation for active
manufacturer issued by concerned regulatory substance exported to EU to M/s Huangshi Shixing
authority of country of origin. Pharmaceutical Co., Ltd., No. 73 East Jinshan Road,
Huangjinshan Development Zone, Huangshi, Hubei,
P.R. China issued by Hubei Medical Products
Administration valid upto 1st June 2025. The certificate
confirms that the manufacturing plant complies with
requirement of Chinese Good Manufacturing practices.
Firm has submitted copy of DML (E20200125) in

name of M/s Huangshi Shixing Pharmaceutical Co.,
Ltd., No. 73 East Jinshan Road, Huangjinshan
Development Zone, Huangshi, Hubei, P.R. China
issued by Hubei Drug Administration valid upto 28th
September 2025.
3. Documents for the procurement of API with approval Not submitted
5. Compliance Record of HPLC software 21CFR & Not Submitted
and accelerated)
1.5.2  Justification is required for not considering the The firm has revised the label claim as per
hydrated form in label claim reference formulation considering the hydrated
form along with submission of Rs. 30000/- on
deposit slip No#7210225081. The revised label
claim is as under:
Each Capsule Contains:
Azithromycin Dihydrate equivalent to
azithromycin…………………..250mg
2.3.R.1  Provide copy of Batch Manufacturing Record Firm has submitted copy of Batch Manufacturing
(BMR) for all the batches of drug product for Record (BMR) for all the batches of drug product
which stability studies data is provided in for which stability studies data is provided in
Module 3 section 3.2.P.8.3> Module 3 section 3.2.P.8.3>
3.2.S.4  Justification is required for setting assay  The firm submitted that in specification and
specification of drug substance on “dried basis testing method Assay limits is 94.5% to 103.0%
instead of anhydrous basis” by drug product that is same as per USP monograph and
manufacturer with reference to mentioned in analytical raw data report and
recommendations of USP monograph. Certificate of Analysis. The firm submitted that
 Submitted analytical method verification report rectification of dried basis has been made and
declares the details for “Azithromycin 500mg Fees has been submitted against typographical
tablets”. error having challan No. 7869667766 of
Rs.7500/-
 The firm has submitted Azijet is a suggested
brand name and Azithromycin is a generic. We
have performed the verification on Azijet 250
Capsules and there is no difference in product
“Azijet” and “Azithromycin.”
3.2.P.1  Justify the role of purified water used in the Purified water is used as a solvent for binder
applied formulation, clarify? solution preparation.
3.2.P.2  Finished Pharmaceutical development report for  Finished Pharmaceutical development report for
Aziject 500mg tablet is submitted instead of Azijet 250mg Capsules is submitted.
Aziject 250mg capsule, clarify? Pharmaceutical development report for Aziject
 Submit the image/picture/snapshot of innovator 500mg tablet is attached by mistake
/reference/comparator pack against which  Image/picture/ snap shot of
Pharmaceutical equivalence/Comparative innovator/reference/comparator pack is
dissolution profile studies have been performed submitted.
and shall reveal the details of brand name,  The firm submitted that for stability testing, the
dissolution media pH 6.0 sodium dihydrogen
manufacturer, batch# and expiry date of the orthophosphate buffer is used that is
innovator /reference/comparator product recommended by BP. While for CDP 3 different
 Selection of dissolution media (phosphate pH dissolution media used that is 0.1M
buffer ph 4.5, ph 6, ph 7.5) shall be justified with phosphate buffer, pH 4.5, 0.1M phosphate buffer
reference to applicable guidelines pH 6.0 and 0.1M phosphate buffer pH 7.5.
 Clarification is required as the submitted details Reference of selection of this 3 pH is “Clinical
show that the reference product against which Pharmacology and biopharmaceutics review
pharmaceutical equivalence and CDP studies is application number 50-784”. CDP has been
performed is from two different supplier performed with reference to this guideline.
 Pharmaceutical equivalence and CDP
performed against same reference product that is
Azomax 250mg capsule. Details are provided.
Azomax 250mg capsule
Manufactured for:
Novartis Pharma (Pakistan) Limited By
M/s GSK Consumer Healthcare Pakistan Limited
Jamshoro
Sandoz a Novartis Division
3.2.P.5  Justification is required for using BP  The firm submitted that according to USP
specification for drug product while drug monograph of Azithromycin Capsule
substance is analyzed as per USP monograph by “Amperometric electrochemical detector” is
drug substance manufacturer and drug product required that we don’t have this detector so, we
manufacturer have adopted BP monograph for capsule
 Justification is required for not mentioning the analysis in which UV detector is used.
time for dissolution test in finished product  The firm submitted that dissolution time is
specifications as recommended by BP. 45minutes and is mentioned in analytical testing
 In batch analysis in column of quantity 1500 method and it is now mentioned in specification
tablets are written instead of capsule, clarify as well. Revised Specification and testing
method is submitted.
 The firm submitted that in Analytical Raw Data
1500 capsules mentioned while in the certificate
of analysis it was mistakenly written 1500
tablets. The firm has submitted revised COA.
Fees Rs.7500/- has been submitted against
typographical error having challan No.
54963436130.
3.2.P.6  The submitted COA of reference / working We have procured one Reference standard that is
standard follow USP specifications while of USP. So we utilize USP reference standard to
finished drug product follow BP specifications standardize the working standard and that same
working standard used for finished drug product
analysis.
3.2.P.8  Documents for the procurement of API with  Firm has submitted copy of invoice dated 09-12-
approval from DRAP is not submitted 2021 for import of 04kg of Azithromycin
 Record of Digital data logger for temperature Dihydrate in name of M/s Pinnacle Biotech
and humidity monitoring of stability chambers (Pvt.) Ltd attested by AD (I&E) DRAP Karachi
(real time and accelerated) is not submitted dated 28-12-2021. Firm has also submitted copy
of form 6 dated 28-12-2021 for import of 04kg
of Azithromycin Dihydrate in name of M/s
Pinnacle Biotech (Pvt.) Ltd attested by AD
(I&E) DRAP Karachi dated 28-12-2021.
(real time and accelerated) is submitted.
Decision: Deferred for submission of following:
 CDP studies in three physiological medias (i.e. 0.1N HCl pH 1.2, Acetate Buffer pH 4.5 and Phosphate
Buffer pH 6.8)
 Justification for use of USP reference / working standard for analysis of product that follow BP
specifications
 Analysis of drug substance as per BP monograph by drug product manufacturer
 Registration Board further decided that firm shall submit the fee of Rs. 7,500/- for correction/pre-
approval change (typo error), as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
M/s Carer Pharmaceuticals Industries, Plot # 27, Main Road, Rawat Industrial Estate, Rawat.
The Central Licensing Board in its 278th meeting held on 10th-11th December, 2020 has considered and
approved the grant of Drug Manufacturing License by way of formulation with following five sections to
M/s, Carer Pharmaceuticals Industries Plot # 27, Main Road, Rawat Industrial Estate, Rawat under Drug
Manufacturing License No. 000925 by way of Formulation vide approval letter No. F. 1-32/2016-Lic dated
07th June 2021. The Drug Manufacturing License No. 000925 by way of formulation is hereby issued w.e.f.
18-03-2021.
S No. Section
1. Capsule Section (General) Section
2. Dry Powder Suspension (General) Section
3. Sachet (General) Section
4. Ampoule (General) Section
5. Tablet (General) Section

715. Name, address of Applicant / Marketing M/s Carer Pharmaceuticals Industries., Plot No. 27 Main
Authorization Holder Road, Rawat Industrial Estate, Rawat
Name, address of Manufacturing site. M/s Carer Pharmaceuticals Industries., Plot No. 27 Main
Road, Rawat Industrial Estate, Rawat
☐ Importer
GMP status of the Finished product New license granted on 07/06/2021
manufacturer
Evidence of approval of manufacturing New license granted vide letter No. F. 1-32/2016-Lic dated
facility 07/06/2021.
Tablet (general), Capsule (general), Sachet (general), dry
powder suspension (general) and ampoule (general) sections
are approved.
☐ Export sale
The proposed proprietary name / brand Caraflox 500mg Tablet
name
Pharmaceutical ingredient (API) per unit Levofloxacin (as Hemihydrate)………..500mg
Pharmacotherapeutic Group of (API) Fluoroquinolones
specifications
The status in reference regulatory LEVAQUIN 500mg film coated tablets, USFDA approved
authorities Discontinued**Federal Register determination that product
was not discontinued or withdrawn for safety or effectiveness
reasons**
Levofloxacin 500mg film-coated tablets MHRA Approved
For generic drugs (me-too status) Leflox 500mg Tablet by M/s Getz Pharma (Reg#26163)
Name and address of API manufacturer. M/s Zhejiang East-Asia Pharmaceutical Co., Ltd., Economic
Development Zone of Sanmen County, Zhejiang 31700, P.R.
China
specifications, analytical procedures and its verification, batch
substance and drug product.
Module III (Drug Substance) The firm has submitted detail of nomenclature, structure,
substance
Batches: (DC-0401-1203001, DC-0401-1203002, DC-0401-
1203003)
Module-III (Drug Product): The firm has submitted detail of manufacturers, description of
manufacturing process and controls, specifications, analytical
procedure, batch analysis and justification of specification,
Pharmaceutical equivalence and Firm has submitted results of pharmaceutical equivalence for
comparative dissolution profile their product against product Leflox 500mg tablet by M/s Getz
Pharma by performing quality tests (Identification, uniformity
of dosage units, disintegration test, dissolution, assay)
CDP has been performed against the product Leflox 500mg
tablet by M/s Getz Pharma in acidic 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 validation/verification of Firm has submitted method verification studies including
product Accuracy, precision (repeatability).
Manufacturer of API M/s Zhejiang East-Asia Pharmaceutical Co., Ltd., Economic Development Zone of
Sanmen County, Zhejiang 31700, P.R. China
API Lot No. DC-004-2112011
Description of Pack Alu-Alu Blister packed in unit carton
No. of Batches 03
1. Reference of previous approval of N/A
firm (if any)
2. Approval of API/ DML/GMP certificate of The firm has submitted copy of cGMP certificate of M/s
API manufacturer issued by concerned Zhejiang East-Asia Pharmaceutical Co., Ltd., Coastal
regulatory authority of country of origin. Industrial city, Pubagang town, Sanmen County, Zhejiang
China issued by China Food & Drug Administration valid upto
15-08-2021.
3. Documents for the procurement of API with Firm has submitted copy of clearance certificate for import of
approval from DRAP (in case of import). 05kg Levofloxacin Hemihydrate from M/s Zhejiang East Asia
Pharmaceutical Company., Ltd China attested by AD (I&E)
DRAP Islamabad dated 11-05-2022.
4. Data of stability batches will be supported Firm has submitted data of stability batches supported by
by attested respective documents like attested respective documents like chromatograms, Raw data
chromatograms, Raw data sheets, COA, sheets, COA, summary data sheets etc.
5. Compliance Record of HPLC software Not submitted
testing
6. Record of Digital data logger for Record of Digital data logger for temperature and humidity
temperature and humidity monitoring of monitoring of stability chambers (real time and accelerated) is
stability chambers (real time and submitted
accelerated)
1.6.5  Valid GMP certificate / DML of the Drug  The firm has submitted copy of DML
Substance manufacturer issued by (License#20000312) of M/s Zhejiang East-Asia
relevant regulatory authority of country Pharmaceutical Co., Ltd., Coastal Industrial city,
of origin is required Pubagang town, Sanmen County, Zhejiang China
 Address mentioned on submitted GMP valid upto 07-10-2024 verified from NMPA website.
certificate is different than that given in  The firm has corrected address in section 1.6.5 as per
section 1.6.5 DML:
M/s Zhejiang East-Asia Pharmaceutical Co., Ltd.,
Coastal Industrial city, Pubagang town, Sanmen
County, Zhejiang 317100, P.R., China
2.3.R.1  Provide copy of Batch Manufacturing  Firm has submitted copy of Batch Manufacturing
Record (BMR) for all the batches of drug Record (BMR) for all the batches of drug product for
product for which stability studies data is which stability studies data is provided in Module 3
provided in Module 3 section 3.2.P.8.3> section 3.2.P.8.3>
3.2.S.4  Signed copies of drug substance  Signed copies of drug substance specifications by
specifications by drug product drug product manufacturer is submitted
manufacturer shall be submitted  Result for specificity test is submitted in method
 Result for specificity test are not verification study
submitted in method verification study
 Test for specific rotation is not  Firm has submitted revised batch analysis report of
performed in batch analysis by drug drug substance in which Test for specific rotation is
product manufacturer as recommended performed
by USP
3.2.P.2  Justification shall be submitted for not  The firm submitted that CDP has been performed with
performing pharmaceutical equivalence comparator pack (Leflox 500mg tablets) due to
and CDP studies against the innovator unavailability of innovator’s pack
product  Image/picture/snapshot of innovator
 Submit the image/picture/snapshot of /reference/comparator against which Pharmaceutical
innovator /reference/comparator pack equivalence/Comparative dissolution profile studies
against which Pharmaceutical have been performed is submitted
equivalence/Comparative dissolution
profile studies have been performed and
shall reveal the details of brand name,
manufacturer, batch# and expiry date of
the innovator /reference/comparator
product
3.2.P.5  Justification is required for not  The firm has submitted revised analytical method
mentioning the number of USP test used mentioning USP test 1 for dissolution test.
for dissolution study  The firm submitted mentioned was a typing mistake
 The rpm used in dissolution study and now rpm used in dissolution study is corrected as
(50rpm) is different than that per USP monograph (75rpm).
recommended by USP monograph  Result for specificity test in method verification study
(75rpm) is submitted
 Result for specificity test are not
submitted in method verification study
3.2.P.8  The batch size of applied formulation is  The firm submitted that batch size is mentioned now
neither mentioned in batch analysis nor in in batch analysis report and revised batch analysis
stability summary sheets clarify? report is submitted
 The submitted UV spectra does not  The firm submitted that UV spectra was software
depict the batch number or dosage form generated report now batch No. and strength of
of applied formulation product added
Decision: Approved:
 Fee of Rs. 7,500/- for correction/pre-approval change (typo error), as per notification No.F.7-11/2012-
 Registration Board directed the QA division to conduct the GMP inpevction during active production.
M/s Pasteur & Fleming Pharma Plot No. P-70-A, Road No. 04, Phase 3, Industrial Estate Hattar, KPK.
The Central Licensing Board in its 283rd meeting held on 28th October, 2021 has considered and approved
the grant of Drug Manufacturing License by way of formulation with following five sections to M/s Pasteur
& Fleming Pharma Plot No. P-70-A, Road No. 04, Phase 3, Industrial Estate Hattar, KPK under Drug
11th November 2021. The Drug Manufacturing License No. 000945 by way of formulation is hereby issued
w.e.f. 10-11-2021.
1. Tablet (Hormone)
2. Tablet (General)
4. Dry Powder Suspension (General)
5. Cream/Ointment Section (General)

716. Name, address of Applicant / Marketing Pasteur & Fleming Pharma, Plot # P-70-A, Phase–
Authorization Holder III, Road No.4, Industrial Estate Hattar KPK.
Name, address of Manufacturing site. Pasteur & Fleming Pharma, Plot # P-70-A, Phase–III,
Road No.4, Industrial Estate Hattar KPK.
☐ Importer
GMP status of the firm New DML issued on 11-11-2021
section.
☐ Export sale
The proposed proprietary name / brand name Loxit 30mg Capsules
Pharmaceutical ingredient (API) per unit Duloxetine HCl enteric coated pellets (17%) eq. to
Duloxetin……………..……30mg
Pharmacotherapeutic Group of (API) Selective serotonin and norepinephrine reuptake
inhibitors (SSNRIs) Anti-Depressants
The status in reference regulatory authorities CYMBALTA (20mg, 30mg, 60mg) delayed-release
capsules, USFDA Approved
For generic drugs (me-too status) Dulan 30mg capsule by M/s Hilton Pharma
(Reg.No#055447)
Name and address of API manufacturer. Vision Pharmaceuticals (Pvt.) Ltd., Plot No. 22-23,
Industrial Triangle , Kahuta Road Islamabad
substance.
Stability Studies of Drug Substance Stability Studies of Drug Substance is submitted.
(Conditions & duration of Stability studies) However, Stability Studies of Drug Substance is not
readable
specifications, analytical procedures, verification of
container closure system and stability study.
Pharmaceutical Equivalence and Comparative Firm has submitted pharmaceutical equivalence
Dissolution Profile studies of their product against the product Dulan
capsule 30mg by performing quality tests
(Description, Identification, dissolution and Assay)..
against Dulan capsule 30mg by M/s Hilton Pharma
Limited in 0.1N HCl (pH 1.2) Acetate buffer (pH 4.5),
& Phosphate Buffer (pH 6.8). The values for f2 are in
product study including specificity, precision and accuracy.
Manufacturer of API Vision Pharmaceuticals (Pvt.) Ltd., Plot No. 22-23, Industrial Triangle , Kahuta Road
Islamabad
API Lot No. DXT291
Description of Pack Alu-Alu Blisters packed in bleechboard box
Batch Size 1500 capsules 1500 capsules 1500 capsules
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API The firm has submitted cGMP certificate of M/s Vision
manufacturer issued by concerned regulatory Pharmaceuticals issued on 31-01-2019 based on
authority of country of origin. inspection conducted on 11-02-2019.
3. Documents for the procurement of API with approval Firm has submitted copy of commercial invoice for
from DRAP (in case of import). purchase of 01Kg of Duloxetine (HCL) EC pellets 17%
from M/s Vision Pharmaceuticals (Pvt.) Ltd.,
Islamabad.
respective documents like chromatograms, Raw data by unattested respective documents like
sheets, COA, summary data sheets etc. chromatograms, Raw data sheets, COA, summary data
sheets etc.
humidity monitoring of stability chambers (real time temperature and humidity monitoring of stability
and accelerated) chambers (real time and accelerated).
1.6.5 Submit valid GMP certificate / DML of the The firm has submitted copy of cGMP certificate of
Drug Substance manufacturer issued by M/s Vision Pharmaceuticals issued on 22-08-2022
relevant regulatory authority of country of based on inspection conducted on 14-06-2022.
origin
2.3.R.1  Justification shall be submitted for the The firm submitted that actually we had done the
dispensed quantity of Duloxetine (HCl) EC calculation in the term of kilogram on the excel sheet
Pellets 17% against the label claim with the digits were not seen as after the decimal point
reference to the potency of Duloxetine (HCl) were rounded off now we have done it again in the
EC Pellets determined during drug substance term of grams than three digits have been clarified.
analysis by M/s Pasteur & Fleming Pharma. We have use this formula for dispensed quantity
with given potency as 17.15 %.
Qty per caps = 100/potency x label claim

Loxit Capsules = 100/17.15 * 30= 175mg/ Cap
So,
Batch Size is = 1500 capsules
175x1500/1000
262.5gm/ Batch
3.2.S.4  Copies of the Drug substance specifications  Copies of the Drug substance specifications and
and analytical procedures used for routine analytical procedures used for routine testing of
testing of the Drug substance by Drug the Drug substance by Drug Product manufacturer
Product manufacturer is required. is submitted.
 Analytical Method Verification studies  Analytical Method Verification studies including
including specificity, accuracy and specificity, accuracy and repeatability (method
repeatability (method precision) performed precision) performed by the Drug Product
by the Drug Product manufacturer for drug manufacturer for drug substance is submitted.
3.2.S.7  Readable copies of stability data of drug Firm has submitted stability study data of 3 batches
substance shall be submitted of drug substance at both accelerated as well as real
30°C ± 2°C / 65% ± 5% RH for 18 months.
Batches: (DXT250, DXT256, DXT 258)
3.2.P.2  Justification shall be submitted for not  The firm submitted that at the time of stability
performing pharmaceutical equivalence and study we searched a Cymbalta capsules 30mg lot
CDP studies against the innovator product but couldn’t find the innovator product of Loxit
 Submit the image/picture/snapshot of 30mg capsules, the innovator’s product was not
innovator /reference/comparator pack against available at market and we got only the Brand
which Pharmaceutical Leader since we started this work for saving time
equivalence/Comparative dissolution profile brand leader Dulan Capsules 30mg capsules from
studies have been performed and shall reveal Hilton Pharma Pvt. Ltd., Karachi having
the details of brand name, manufacturer, Registration Number.055447, DML # 000136,
batch# and expiry date of the innovator batch Number. 141104 instead of Innovator, Brand
/reference/comparator product Leader has also done studies according to the
innovator’s specs that we also considered it
appropriate.
 Image/picture/snapshot of innovator / comparator
pack against which Pharmaceutical
equivalence/Comparative dissolution profile
studies have been performed is submitted
3.2.P.5  Signed copies of finished product  Signed copies of finished product specifications,
specifications, analytical procedure and analytical procedure and method verification
method verification studies shall be studies is submitted
submitted  The firm submitted that in Loxit hard gelatine
 Justification shall be submitted for not capsules 30mg (Duloxetine HCl) the ratio of
including the test for uniformity of dosage Active pharmaceuticals Ingredient (API) and label
unit in finished product specifications as claimed of Loxit capsules 30mg is more than
recommended by USP 25mg, so uniformity of content cannot be applied
 HPLC column details shall be submitted for here only weight variation will be applied in this
assay test case. As per USP monograph the product
 The USP test number adopted for dissolution Containing 25 mg or more of a drug substance or
test is not mentioned in product comprises 25% or more (by weight) of one
specifications capsule. However uniformity of dosage unit by
 Unsinged copies of Batch analysis of three content uniformity shall be included in
batches are submitted specifications
 The firm submitted that USP test No#01 is used
for dissolution test.
 The firm has provided details of HPLC column
used for assay test, C8; 4.6X75MM,3.5µm
 Singed copies of Batch analysis of three batches
are submitted
3.2.P.8  Unattested and unsigned documents like  Signed documents like Raw data sheets, COA,
Raw data sheets, COA, summary data sheets summary data sheets etc. are submitted
etc. are submitted  Chromatograms for dissolution test are submitted
 Chromatograms for dissolution test are not
submitted
Decision: Approved.
 Manufacturer will place first three production batches on long term stability studies throughout proposed
application.
Registration letter will be issued after submission of:
 Revised finished product specifications including the test for uniformity of dosage unit i.e. content
uniformity as per USP monograph
 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.
M/s World Biz Pharmaceutical Company Plot#340 Phase-II, Industrial Estate, Multan
the grant of Drug Manufacturing License by way of formulation with following one section to M/s World
Biz Pharmaceutical Company Plot#340 Phase-II, Industrial Estate, Multan under Drug Manufacturing
License No. 000942 by way of Formulation vide approval letter No. F. 1-25/2008-Lic dated 17th September
2021. The Drug Manufacturing License No. 0009942 by way of formulation is hereby issued w.e.f. 13-09-
2021.
6. Oral Liquid Syrup section (General).
717. Name, address of Applicant / Marketing M/s World Biz Pharmaceutical Company Plot#340
Authorization Holder Phase-II, Industrial Estate, Multan
Name, address of Manufacturing site. M/s World Biz Pharmaceutical Company Plot#340
Phase-II, Industrial Estate, Multan
☐ Importer
GMP status of the firm New DML issued on 13-09-2021
dated 17-09-2021 specifying Oral Liquid Syrup
section (General).
☐ Export sale
The proposed proprietary name / brand name MetroBiz Suspension 200mg/5ml
Pharmaceutical ingredient (API) per unit Metronidazole as benzoate………………200mg
(B.P Specifications)
Pharmacotherapeutic Group of (API) Anti-amoebic and anti-infective
Pharmaceutical form of applied drug Oral suspension
Reference to Finished product specifications B.P Specifications
Proposed Pack size 30ml, 60ml, 90ml, 100ml, 120ml,, 450ml
The status in reference regulatory authorities Metronidazole 200mg/5ml Oral Suspension by
Rosemont Pharma (MHRA Approved)
For generic drugs (me-too status) Flygyl Suspension by M/s Sanofi-aventis Pakistan
(Reg.No. 001214)
Name and address of API manufacturer. M/s Aarti Drugs Limited., Plot No 109 – D Mahendra
Industrial Estate Road No 29, Sion (East), Mumbai -
400 022, INDIA.
Module-III Drug Substance: Firm has submitted detail of nomenclature,
structure, general properties, solubility,
and controls, specifications, analytical procedures and
Batches: (MBO/402046, MBO/406279,
MBO/410534)
Module-III Drug Product: Firm has submitted detail of drug product
Pharmaceutical development, manufacturer,
manufacturing process and process control, process
validation protocols, control of drug Product,
specifications, analytical procedures, analytical
method verification studies, batch analysis,
materials, container closure system and stability
study.
Pharmaceutical Equivalence and Comparative Pharmaceutical Equivalence is established against
Dissolution Profile Citzin syrup by M/s Sanofi Aventis Pakistan by
performing quality tests (Identification, pH,
deliverable volume and Assay).
Manufacturer of API M/s Aarti Drugs Limited., Plot No 109 – D Mahendra Industrial Estate Road No 29,
Sion (East), Mumbai - 400 022, INDIA.
API Lot No. MBO/12090523
Description of Pack An amber glass bottle containing yellow coloured suspension with characteristic
(Container closure system) pleasant flavour, labelled sealed with pp. aluminium cap packed in specific unit
carton. (60ml)
Frequency Accelerated: 0, 3 (Months)
Real Time: 0, 3 (Months)
Batch No. RD-MS-001 RD-MS-002 RD-MS-003
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP Certificate of M/s
manufacturer issued by concerned regulatory Aarti Drugs Limited., Plot No. K-40/41, MIDC,
authority of country of origin. Tarapur, Biosar, Tal-Palghar, Dist Thane 401506
Mahrashtra State, India issued by Food and Drugs
Administration Maharashtra State, India valid upto 29th
November 2024. The certificate specifies that the firm
is operating at satisfactory level of GMP compliance.
3. Documents for the procurement of API with approval Firm has submitted copy of request for Loan of raw
from DRAP (in case of import). material to M/s British Pharmaceutticals 23-Km
Sheikhupura Road, Lahore dated 11-07-2022.
M/s British Pharmaceutticals 23-Km Sheikhupura
Road, Lahore has accepted the request for Loan of Raw
material dated 12-07-2022.
Firm has submitted copy of Agreement for Loan of raw
material to M/s British Pharmaceutticals 23-Km
Sheikhupura Road, Lahore dated 12-07-2022.
Firm has submitted copy of receiving letter addressed
to assistant director PE&R dated 14-02-2023 for
Borrowing of API, “Metronidazole Benzoate” for
product development, R&D and Stability testing.
Firm has submitted that the Metronidazole benzoate
material of quantity 10Kg was obtained via loan from
M/s British Pharmaceuticals Lahore.
Copy of Form 3, 7, COA, commercial invoice
(invoice# EXP/1750/22-23) dated: 21-09-2022 is
submitted. However the invoice not cleared by AD
(I&E) DRAP filed office
4. Data of stability batches will be supported by attested The firm has submitted data of stability batches
respective documents like chromatograms, Raw data supported by attested respective documents like
sheets, COA, summary data sheets etc. chromatograms, raw data sheets, COA, summary data
sheets etc.
5. Compliance Record of HPLC software 21CFR & Audit trail report for product testing is submitted
humidity monitoring of stability chambers (real time logger for temperature and humidity monitoring of
and accelerated) stability chambers (real time and accelerated) for 3
months only.
XI
1.6.5  Address mentioned on GMP certificate is The firm submitted that address mentioned on GMP
different than that given in section 1.6.5, certificate is same as mentioned on the used Lot of
clarify API. The firm has revised the address in section
1.6.5 as M/s Aarti Drugs Limited., Plot No. K-40,41,
MIDC, Tarapur-Biosar, Tal-Plghar Dist. Thane,
India
3.2.S.4  In contrary to the recommendations of BP  Firm has submitted revised drug substance
monograph justification shall be submitted specifications and included the tests for loss on
for not including the tests for loss on drying drying and sulphated ash
and sulphated ash in drug substance  The firm submitted that suphated ash test was
specification by drug product manufacturer performed but skipped in the certificate of analysis
 Justification shall be submitted for not typographically and submitted revised certificate
performing the tests for sulphated ash in of analysis of API.
batch analysis of drug substance by drug
product manufacturer
3.2.P.2  In section 3.2.P.2 of form 5F details for  The firm submitted that this was a typographical
Cetirizine Hydrochloride syrup is submitted error. Revised data in section 3.2.P.2 is submitted
 Submit the image/picture/snapshot of  Image/picture/snapshot of innovator
innovator /reference/comparator pack against /reference/comparator pack against which
which Pharmaceutical Pharmaceutical equivalence studies have been
equivalence/Comparative dissolution profile performed is submitted.
studies have been performed and shall reveal  The firm submitted that comparative product used
the details of brand name, manufacturer, was Flagyl Suspension 200mg/5ml (120ml)
batch# and expiry date of the innovator Batch No#AA263
/reference/comparator product Mfg date; Sep, 2022
Exp date; Aug, 2024
 The submitted pharmaceutical equivalence  Revised Pharmaceutical equivalence report
reports shows comparison of SetBiz Syrup performed against Flagyl Suspension 200mg/5ml
against Citzin Syrup, clarify by M/s Sanofi Aventis Pakistan by performing
quality tests (Appearance, Identification, pH,
deliverable volume and Assay).
3.2.P.5  Justification is required as specification for  The firm submitted that identification of the
identification test is by HPLC instead IR with product was performed by the HPLC retention
reference to recommendations of BP time. HPLC is more precise technique than FTIR.
mongraph So, that’s why in specifications, identification via
 Justification is required as tests for HPLC is mentioned
antimicrobial preservative content and  Antimicrobial preservative content and efficacy
efficacy of preservative is not included in test study was performed and documents are
specification submitted.
 Method used for standard solution  The firm submitted that method used for standard
preparation for assay is not as per solution preparation is same as per
recommendations of BP monograph, clarify recommendation of BP, only Dimethyl formamide
(Dimethylformamide is not used along with was skipped due to non-availability. Once product
methanol for dissolution of standard is registered, we will adopt the same procedure as
metronidazole benzoate) of BP monograph
3.2.P.8  Justification is required as batch analysis  The firm submitted that pack size use for stability
show pack size of 60ml while BMR shows and batch analysis was 90ml. The firm has
pack size of 90ml of trial batches submitted revised batch analysis report.
 6th month time point stability study data is not  Firm has submitted stability study data at 6th
submitted month time point
 The submitted commercial invoice is not  Commercial invoice (invoice# EXP/1750/22-23)
attested by AD (I&E) DRAP field office dated: 21-09-2022 is submitted. However the
invoice not cleared by AD (I&E) DRAP filed office
Decision: Keeping in view the remarks of evaluater and the submission of revised information and data with
multiple typographic errers as admitted by the firm and not submitting the DRAP office attested
invoice for the API used for production of trial batches for stability studies, the board decided to
deffer the case for the submission complete dossier with new batches with full fee of registration as
Case No. 05; Registration application of Human drugs on Form 5-F on export facilitation
Assistant director PR-I/EFD vide letter No.F.1-6/2019-PR-I (EFD) dated 28-02-2023 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 2021-
2022 and submitted their applications for priority consideration in lieu of export facilitation for Registration
Board please.,
718. Name, address of Applicant / Marketing M/s Macter International Ltd., F-216, SITE, Karachi-Pakistan.
Name, address of Manufacturing site. M/s Macter International Ltd., F-216, SITE, Karachi-Pakistan.
☐ Importer
GMP status of the Finished product Firm has submitted copy of GMP certificate dated 05-08-2022
manufacturer based on inspection conducted on 04-08-2021
Evidence of approval of manufacturing Firm has submitted copy of letter No. F. 2-13/95-Lic (Vol-III)
facility dated 10-12-2019 which specifies injectable section (ceph)
☐ Export sale
Avicef 2.5gm Powder for Injection
name
Pharmaceutical ingredient (API) per unit Ceftazidime as Ceftazidime pentahydrate……..…2g
Avibactam as avibactam sodium ………………0.5g
Pharmaceutical form of applied drug Sterile powder for injection
Pharmacotherapeutic Group of (API) Ceftazidime belongs to the group of antibiotics called
“cephalosporin”
Avibactam is “beta-lactamase inhibitor”
Not submitted
specifications
The status in reference regulatory Zavicefta 2 g/0.5 g powder for concentrate for solution for
authorities infusion MHRA Approved
Zavicefta 2 g/0.5 g powder for concentrate for solution for
infusion TGA Approved
AVYCAZ (ceftazidime/avibactam) 2g/0.5g for injection
USFDA Approved
For generic drugs (me-too status) Zavicefta Injection 2g/0.5g Powder for Concentrate for
Solution for Infusion by M/s Pfizer Pakistan Ltd (Reg#106848)
Name and address of API manufacturer. M/s Chifeng Addisun Pharmaceutical Co., Ltd., No. 3
Minsheng street, Economic development zone of Hongshan
District , Chifeng, Inner Mongolia, China
container closure system and stability studies of drug substance
and drug product is submitted.
substance.
(Conditions & duration of Stability Real time: 30°C ± 2°C / 65% ± 5%RH for 24 months
studies) Accelerated: 40°C ± 2°C / 75% ± 5%RH for 6 months
Batches: (180601, 180602, 180603)
procedure and its validation studies, batch analysis and
closure system and stability studies of drug product.
Pharmaceutical equivalence and Pharmaceutical Equivalence has been established against the
comparative dissolution profile brand that is Avycaz 2.5g Powder for injection by M/s GSK
Italy., by performing quality tests (Appearance, identification,
average weight, pH, Assay and related substances).
Analytical method validation/verification Firm has submitted method validation studies including
of product linearity, accuracy, precision, specificity and robustness.
Manufacturer of API M/s Chifeng Addisun Pharmaceutical Co., Ltd., No. 3 Minsheng street, Economic
development zone of Hongshan District , Chifeng, Inner Mongolia, China
API Lot No. 2105001
Description of Pack
25cc Clear glass vial, rubber stopper, flip off seal and leaflet in unit carton (1’s)
Batch No. 21SB-077-001 21SB-078-002 21SB-079-003
Batch Size 100 Vials 100 Vials 100 Vials
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of Firm has submitted copy of GMP certificate in the name of M/s
API manufacturer issued by concerned Chifeng Addisun Pharmaceutical Co., Ltd., 3 Minsheng street,
regulatory authority of country of origin. Economic development zone of Hongshan District , Chifeng,
China issued by China Food and Drug Administration valid
upto 21-02-2022.
3. Documents for the procurement of API Firm has submitted copy of invoice dated 01-04-2020 for
with approval from DRAP (in case of import of 1kg of Avibactam and Ceftazidime sterile (Working
import). standard & Impurities) in name of M/s Macter International
Limited. However, the invoice is not attested by AD (I&E)
DRAP field office.
testing
6. Record of Digital data logger for Submitted
accelerated)
1.5.6  Mention the reference specifications of the  The firm has mentioned Innovator’s
finished product specifications for applied product
1.6.5  Valid GMP certificate of drug substance Firm has submitted copy of DML
manufacturer issued by relevant regulatory (License#Nei20160028) in the name of M/s
authority of country of origin is required Chifeng Addisun Pharmaceutical Co., Ltd., 3
Minsheng street, Economic development zone of
Hongshan District, Chifeng, China issued by
Drug Administration of Nei Monggol China
valid upto 27-12-2025.
3.2.S.4  Copies of the Drug substance specifications and  Copies of the Drug substance specifications
analytical procedures used for routine testing of and analytical procedures used for routine
the Drug substance by Drug product manufacturer testing of the Drug substance by Drug product
is required. manufacturer is submitted.
 Analytical Method Verification studies including  Firm has submitted analytical method
specificity, accuracy and repeatability (method validation studies including linearity, accuracy,
precision) performed by the Drug Product precision, specificity and robustness performed
manufacturer for drug substance shall be by the Drug Product manufacturer for drug
submitted. substance.
 Justification is required for not performing the test  Test for content uniformity has been performed
for content uniformity and pyridine content in by drug product manufacturer and revised
batch analysis of drug substance by drug product reports submitted. However, test for pyridine
manufacturer as recommended by drug substance content is not submitted.
manufacturer
3.2.P.1  Provide information including type of diluent, its  The firm submitted that sterile water for
composition, quantity or volume, specifications injection will be provided with applied drug
and regulatory status in Pakistan for the diluent product that is already registered with M/s
which is to be provided along with the applied Macter International
drug.
3.2.P.2  Justification is required since pharmaceutical  Firm has submitted the justification on
equivalence study does not include complete Pharmaceutical Equivalence included complete
testing of the drug product and the innovator testing (Appearance, Identification, Avg.
product including the tests recommended by weight, pH, Assay, Related Substance, Any
innovator product review document (description unspecified impurity, Total Impurity) of the
on reconstitution, reconstitution time, pyridine drug product Avicef 2.5 g powder for injection
content, uniformity of dosage unit, particulate and the innovator product recommended by the
matter, water content, bacterial endotoxins and following guidelines, “Pharmaceutical
sterility) equivalence – Drug products are considered
pharmaceutical equivalents if they have the
same active ingredients, the same dosage form
and are identical in strength, quality, purity, and
identity as the brand-name product [1,
2]”.Report of pharmaceutical equivalence is
submitted.
 Also the equivalence relationships between
brand name and generic drugs are the following
parameters; (API, Dosage form, Dose, Route of
Administration, Labeling.
 The test parameters stated in query already
performed in our in-house testing for finished
product.
3.2.P.3  Justify the batch size of trial batches against the  No justification is submitted for batch size of
number of units required for complete testing of trial batches against the number of units
drug product during stability study including real required for complete testing of drug product
time stability study till claimed shelf life during stability study till claimed shelf life
 Justification shall be submitted for the dispensed  The firm submitted that batch size was
quantity of drug substance against the label claim determined according to the standard mixture,
with reference to the potency of drug substance which is 315.0g for 100vials. The firm further
determined during drug substance analysis by M/s stated that batch was filled according to the
Macter International Ltd. potency of API, which was tested by M/s
 Justification shall be submitted as the content of Macter International.
sodium bicarbonate in premixed drug substance  Firm has submitted that content sodium
are different than that recommended by innovator carbonate in premixed drug substance has been
product corrected and mentioned Certificate of Analysis
for drug substance and stated that COA is
submitted in dossier.
3.2.P.5  Justification is required for not including the test  Firm submitted that reconstitution time,
for reconstitution time, pyridine content, uniformity of dosage unit and water content
uniformity of dosage unit and water content in tests were already performed but didn’t
finished product specification by drug product incorporated in the report and specifications,
manufacturer as recommended by innovator now mentioned in revised report, while
product review document pyridine content test performed and mentioned
 Justification is required for not performing the test in revised report of the drug substance of Avicef
for reconstitutions time, uniformity of dosage 2.5 g powder for injection. However results for
units, pyridine content and water content in batch uniformity of dosage unit is not submitted
analysis by drug product manufacturer as
recommended by innovator product review
document
3.2.P.7  Description of the primary container closure  Clear glass vial 25cc
systems including the type of glass shall be
submitted
3.2.P.8  Justification is required for not performing the test  Firm submitted that test for reconstitution time,
for reconstitutions time, uniformity of dosage uniformity of dosage unit and water content
units, pyridine content and water content in were already performed but didn’t incorporated
stability study by drug product manufacturer as in the report and specifications, now mentioned
recommended by innovator product review in revised report, while pyridine content test
document will be perform in ongoing stability study of the
 Submit document for procurement of API with drug substance Avicef 2.5 g powder for
approval from DRAP injection. However, no revised reports are
submitted
 Firm has submitted copy of invoice dated 17-
06-2021 for import of 1kg of Avibactam and
Ceftazidime sterile ( & Impurities) in name of
M/s Macter International Limited attested by
AD (I&E) DRAP Karachi dated 22-06-2021
 Justification for not performing the test for pyridine content in batch analysis of drug substance by
drug product manufacturer
 Justification as pharmaceutical equivalence study report does not include complete testing of the drug
product and the innovator product including the tests recommended by innovator product review
document (description on reconstitution, reconstitution time, pyridine content, uniformity of dosage
unit, particulate matter, water content, bacterial endotoxins and sterility)
 Justification for the batch size of trial batches against the number of units required for complete testing
of drug product during stability study including real time stability study till claimed shelf life
 Justification for not including the test for reconstitution time, pyridine content, uniformity of dosage
unit and water content in finished product specification by drug product manufacturer
 Results for uniformity of dosage unit in batch analysis of drug product.
 Reports for reconstitution time, uniformity of dosage unit, water content in stability study
 Results for pyridine content in ongoing stability study
Case No. 6: Deferred Registration applications of Human Drugs on form 5F (New DML):
M/s Pinnacle Biotech (Pvt.) Ltd. Plot No. FD-49-A8, FD-50-A8, FD-51-A8, Korangi Creek Industrial
Park, Karachi
the grant of Drug Manufacturing License by way of formulation with following three sections to M/s
Pinnacle Biotech (Pvt.) Ltd., Plot No. FD-49-A8, FD-50-A8, FD-51-A8, Korangi Creek Industrial Park,
Karachi under Drug Manufacturing License No. 000939 by way of Formulation vide approval letter No. F.
2-10/2011-Lic(Vol-I) dated 13th September 2021. The Drug Manufacturing License No. 000939 by way of
formulation is hereby issued w.e.f. 13-09-2021.
5. Tablet (General)
7. Sachet (General)
8. Research & Development Laboratory
719. Name, address of Applicant / M/s Pinnacle Biotech (Pvt.) Ltd. Plot No. FD-49-A8, FD-50-A8,
Marketing Authorization Holder FD-51-A8, Korangi Creek Industrial Park, Karachi.
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
GMP status of the Finished product Firm has submitted cGMP certificate issued on 22-11-2022 based
manufacturer on inspection conducted on 21-10-2022.
Evidence of approval of New license granted vide letter No. F. 2-10/2011-Lic(Vol-I) dated
manufacturing facility 13/09/2021.
Tablet (general), Capsule (general), Sachet (general) and Research
and Development Laboratory section is approved.
Intended use of pharmaceutical ☐Domestic sale
The proposed proprietary name / Neptune 500mg Tablets
brand name
Strength / concentration of drug of Each film coated tablet contains:
Active Pharmaceutical ingredient Ciprofloxacin Hydrochloride equivalent to
(API) per unit Ciprofloxacin………………500mg
specifications
The status in reference regulatory Ciproxin 500mg film-coated Tablets, MHRA Approved.
authorities
For generic drugs (me-too status) Ciproxin 500mg Tablet by M/s Bayer Pakistan Private Limited
(Reg#107222)
Name and address of API M/s Pharmagen Limited., Kot Nabi Bukhsh Wala 34-Km,
manufacturer. Ferozpur Road, Lahore
nomenclature, structure, general properties, solubility, physical
form, manufacturers, description of manufacturing process and
controls, specifications, analytical procedures and its
verifications, batch analysis and justification of specification,
details of reference standards, container closure system and
Stability studies Firm has submitted stability study data as per zone IV-A.
Batches: 00510011/001/2014, 00510011/002/2014,
00510011/003/2014
procedure and its verification studies, batch analysis and
justification of specification, reference standard, container closure
Pharmaceutical equivalence and Firm has submitted results of pharmaceutical equivalence for their
comparative dissolution profile product against ciproxin 500mg tablet by M/s Novartis Pharma
(mfgr) / Bayer Pakistan (MAH) by performing quality tests
(Identification, average weight, disintegration time, uniformity of
dosage units, dissolution, assay)
CDP has been performed against the product ciproxin 500mg
tablet by M/s Novartis Pharma (mfgr) / Bayer Pakistan (MAH) in
Acid media (pH 1.2), acetate buffer (pH 4.5) & Phosphate Buffer
Analytical method Firm has submitted method verification studies including
validation/verification of product Accuracy, precision (repeatability) and Specificity.
Manufacturer of API M/s Pharmagen Limited., Kot Nabi Bukhsh Wala 34-Km, Ferozpur Road, Lahore
API Lot No. 00510011 / 279 / 2021
Description of Pack
Alu-Alu blister packed in unit carton
Stability Storage Condition Real time: 30°C ± 2°C / 65% ± 5%
No. of Batches 03
1. Reference of previous approval of Not submitted
applications with stability study data
of the firm (if any)
2. Approval of API/ DML/GMP The firm has submitted copy of GMP Certificate of M/s
certificate of API manufacturer issued Pharmagen Limited., Kot Nabi Bukhsh Wala 34-Km, Ferozpur
by concerned regulatory authority of Road, Lahore issued on 22-11-2022 based on inspection conducted
country of origin. on 18-11-2022 valid for two years from date of inspection
3. Documents for the procurement of API Not submitted
import).
4. Data of stability batches will be Firm has submitted data of stability batches supported by attested
supported by attested respective respective documents like 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
21CFR & audit trail reports on product reports on product testing is submitted
testing
6. Record of Digital data logger for Not Submitted
temperature and humidity monitoring
of stability chambers (real time and
accelerated)
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  Clarification is required as Drug substance manufacturer has given both USP and BP
specifications and analytical method while drug product manufacturer has given USP
specifications.
 Clarification is required as the batch number mentioned on COA of drug substance by
drug substance manufacturer (00510011 / 279 / 2021) is different than that of drug
product manufacturer (00510011 / 280 / 2021)
3.2.S.5  COA of primary / secondary reference standard including source and lot number shall
be provided.
3.2.P.5  Justification is required for not mentioning the time for dissolution test in finished
product specifications as recommended by USP.
3.2.P.8  Documents for the procurement of API is not submitted
chambers (real time and accelerated) is not submitted
Previous Decision (327th–DRB): Registration Board deferred the case for submission of reply to the above cited
shortcomings.
Response by the firm (10th April 2023):
2.3.R.1  Provide copy of Batch Manufacturing Firm has submitted copy of Batch Manufacturing
Record (BMR) for all the batches of drug Record (BMR) for all the batches of drug product
product for which stability studies data is for which stability studies data is provided in
provided in Module 3 section 3.2.P.8.3> Module 3 section 3.2.P.8.3>
3.2.S.4  Clarification is required as Drug substance  The firm submitted that drug product
manufacturer has given both USP and BP manufacturer tested their material on both
specifications and analytical method while specifications to meet customer requirement
drug product manufacturer has given USP while drug product manufacturer only tested the
specifications. material as per USP.
 Clarification is required as the batch  The firm has submitted revised COA of batch
number mentioned on COA of drug No#(00510011 / 280 / 2021) from drug
substance by drug substance manufacturer substance manufacturer
(00510011 / 279 / 2021) is different than
that of drug product manufacturer
(00510011 / 280 / 2021)
3.2.S.5  COA of primary / secondary reference Firm has submitted both COA of primary /
standard including source and lot number secondary reference standard
shall be provided.
3.2.P.5  Justification is required for not The firm submitted that in specification and
mentioning the time for dissolution test in testing method on page No.09 on 3.6.3 in
finished product specifications as dissolution procedure time 30 minutes is
recommended by USP. mentioned while it was not mentioned in
dissolution parameters and specifications so
revised specification and testing method is
submitted
3.2.P.8  Documents for the procurement of API is  Firm has submitted purchase order from M/s
not submitted Pinnacle Biotech and sale tax invoice and
 Record of Digital data logger for delivery note from M/s Pharmagen Limited for
temperature and humidity monitoring of procurement of API
stability chambers (real time and  Record of Digital data logger for temperature
accelerated) is not submitted and humidity monitoring of stability chambers
(real time and accelerated) is submitted
Decision: Approved.
application.
720. Name, address of Applicant / M/s Pinnacle Biotech (Pvt.) Ltd. Plot No. FD-49-A8, FD-50-A8,
Marketing Authorization Holder FD-51-A8, Korangi Creek Industrial Park, Karachi.
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
GMP status of the Finished product Firm has submitted cGMP certificate issued on 22-11-2022 based
manufacturer on inspection conducted on 21-10-2022.
Evidence of approval of New license granted vide letter No. F. 2-10/2011-Lic(Vol-I) dated
manufacturing facility 13/09/2021.
Tablet (general), Capsule (general), Sachet (general) and Research
and Development Laboratory section is approved.
The proposed proprietary name / Neptune 250mg Tablets
brand name
Active Pharmaceutical ingredient Ciprofloxacin Hydrochloride equivalent to
(API) per unit Ciprofloxacin……………….250mg
specifications
The status in reference regulatory CIPRO (250mg) film coated tablet, USFDA Approved.
authorities
For generic drugs (me-too status) Ciproxin 250mg Tablet by M/s Bayer Pakistan Private Limited
(Reg# 10118)
Name and address of API M/s Pharmagen Limited., Kot Nabi Bukhsh Wala 34-Km,
manufacturer. Ferozpur Road, Lahore
nomenclature, structure, general properties, solubility, physical
form, manufacturers, description of manufacturing process and
verifications, batch analysis and justification of specification,
details of reference standards, container closure system and
Stability studies Firm has submitted stability study data as per zone IV-A.
Batches: 00510011/001/2014, 00510011/002/2014,
00510011/003/2014
procedure and its verification studies, batch analysis and
justification of specification, reference standard, container closure
Pharmaceutical equivalence and Firm has submitted results of pharmaceutical equivalence for their
comparative dissolution profile product against ciproxin 250mg tablet by M/s Novartis Pharma
(mfgr) / Bayer Pakistan (MAH) by performing quality tests
(Identification, average weight, disintegration time, uniformity of
dosage units, dissolution, assay)
CDP has been performed against the product ciproxin 250mg
tablet by M/s Novartis Pharma (mfgr) / Bayer Pakistan (MAH) in
Acid media (pH 1.2), acetate buffer (pH 4.5) & Phosphate Buffer
Analytical method Firm has submitted method verification studies including
validation/verification of product Accuracy, precision (repeatability) and Specificity.
Manufacturer of API M/s Pharmagen Limited., Kot Nabi Bukhsh Wala 34-Km, Ferozpur Road, Lahore
API Lot No. 00510011 / 279 / 2021
Stability Storage Condition Real time: 30°C ± 2°C / 65% ± 5%
No. of Batches 03
1. Reference of previous approval of Not submitted
of the firm (if any)
2. Approval of API/ DML/GMP The firm has submitted copy of GMP Certificate of M/s
certificate of API manufacturer issued Pharmagen Limited., Kot Nabi Bukhsh Wala 34-Km, Ferozpur
by concerned regulatory authority of Road, Lahore issued on 22-11-2022 based on inspection conducted
country of origin. on 18-11-2022 valid for two years from date of inspection
3. Documents for the procurement of API Not submitted
import).
4. Data of stability batches will be Firm has submitted data of stability batches supported by attested
supported by attested respective respective documents like 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
21CFR & audit trail reports on product on product testing is submitted
testing
6. Record of Digital data logger for Not Submitted
temperature and humidity monitoring
of stability chambers (real time and
accelerated)
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  Clarification is required as Drug substance manufacturer has given both USP and BP
specifications and analytical method while drug product manufacturer has given USP
specifications.
 Clarification is required as the batch number mentioned on COA of drug substance
by drug substance manufacturer (00510011 / 279 / 2021) is different than that of drug
product manufacturer (00510011 / 280 / 2021)
3.2.S.5  COA of primary / secondary reference standard including source and lot number shall
be provided.
3.2.P.5  Justification is required for not mentioning the time for dissolution test in finished
product specifications as recommended by USP.
3.2.P.8  The batch number mentioned on chromatograms for assay test at 3rd month time point
of real time and accelerated stability study is T047 instead of T049 clarify
 In real time stability study at 3rd month and 6th month time point of batch#T052,
chromatograms of Batch#T051 is submitted instead of Batch#T052, clarify
 Documents for the procurement of API is not submitted
chambers (real time and accelerated) is not submitted
Previous Decision (327th–DRB): Registration Board deferred the case for submission of reply to the above cited
shortcomings.
Response by the firm (10th April 2023):
2.3.R.1  Provide copy of Batch Manufacturing Firm has submitted copy of Batch Manufacturing
Record (BMR) for all the batches of drug Record (BMR) for all the batches of drug product
product for which stability studies data is for which stability studies data is provided in
provided in Module 3 section 3.2.P.8.3> Module 3 section 3.2.P.8.3>
3.2.S.4  Clarification is required as Drug substance  The firm submitted that drug substance
manufacturer has given both USP and BP manufacturer tested their material on both
specifications and analytical method while specifications to meet customer requirement
drug product manufacturer has given USP while drug product manufacturer only tested the
specifications. material as per USP.
 Clarification is required as the batch  The firm has submitted revised COA of batch
number mentioned on COA of drug No#(00510011 / 280 / 2021) from drug
substance by drug substance manufacturer substance manufacturer
(00510011 / 279 / 2021) is different than
that of drug product manufacturer
(00510011 / 280 / 2021)
3.2.S.5  COA of primary / secondary reference Firm has submitted both COA of primary /
standard including source and lot number secondary reference standard
shall be provided.
3.2.P.5  Justification is required for not The firm submitted that in specification and
mentioning the time for dissolution test in testing method on page No.09 on 3.6.3 in
finished product specifications as dissolution procedure time 30 minutes is
recommended by USP. mentioned while it was not mentioned in
dissolution parameters and specifications so
revised specification and testing method is
submitted
3.2.P.8  The batch number mentioned on  Firm submitted that for stability study 03
chromatograms for assay test at 3rd month batches has been manufactured that is T049,
time point of real time and accelerated T051 and T052. In chromatograms it was typo
stability study is T047 instead of T049 error, correction marked with initial of analyst.
clarify Revised report is submitted
 In real time stability study at 3rd month and  In real time stability study at 3rd month, in
6th month time point of batch#T052, sample 2 chromatogram, it was data entry error
chromatograms of Batch#T051 is that during making batch file T-051 was
submitted instead of Batch#T052, clarify mistakenly written instead of T-052, correction
 Documents for the procurement of API is marked with the initials of analyst. While in
not submitted sample 1 correct batch No. T-052 is already
 Record of Digital data logger for mentioned. Revised report is submitted.
temperature and humidity monitoring of  At 6th month time point, during scanning of
stability chambers (real time and documents chromatograms of T052 was
accelerated) is not submitted mistakenly replaced by T051. Revised report is
submitted.
 Firm has submitted purchase order from M/s
Pinnacle Biotech and sale tax invoice and
delivery note from M/s Pharmagen Limited for
procurement of API
Decision: Approved.
 Registration board decided that firm shall submit the fee of Rs. 7,500/- for correction/pre-approval
change (typo error), as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
M/s Qadir Pharmaceuticals, Veerum Fateh Garh Sahuwala Road, Sialkot.
the grant of Drug Manufacturing License by way of formulation with following seven (07) sections to M/s
Qadir Pharmaceuticals, Veerum Fateh Garh Sahuwala Road, Sialkot under Drug Manufacturing License No.
000944 vide approval letter No. F.1-5/2017-Lic dated 17/09/2021. The Drug Manufacturing License No.
000944 by way of formulation is hereby issued w.e.f. 13-09-2021.
S No. Section
1. Tablet (General)
3. Oral Liquid (General)
4. Liquid Injectable – Vial & Ampoule (General)
5. Capsule (Cephalosporin)
6. Dry Powder Injectable (Cephalosporin)
7. Oral Dry Powder Suspension (Cephalosporin)
721. Name, address of Applicant / Mar keting M/s Qadir Pharmaceuticals, Veerum Fateh Garh
Authorization Holder Sahuwala Road, Sialkot.
Name, address of Manufacturing site. M/s Qadir Pharmaceuticals, Veerum Fateh Garh
Sahuwala Road, Sialkot.
☐ Importer
GMP status of the firm Firm has been granted new license (DML No. 000944)
Evidence of approval of manufacturing facility Firm has submitted copy of letter of issuance of DML
dated 17-09-2021 which specifies Capsule (General)
section.
☐ Export sale
Dy. No. and date of submission Dy. No. 3131 : 02/02/2023
Details of fee submitted PKR 30,000/-: 12/12/2022
The proposed proprietary name / brand name Praq 20mg Capsule
Strength / concentration of drug of Active Each Hard gelatine capsule contains:
Pharmaceutical ingredient (API) per unit Enteric coated pellets (8.5%) of omeprazole equivalent
to omeprazole …….20mg
Pharmaceutical form of applied drug Hard gelatine capsule
The status in reference regulatory authorities Omeprazole 20 mg Gastro-resistant Capsules MHRA
Approved
For generic drugs (me-too status) Risek Capsule 20mg by M/s Getz Pharma
(Reg#19364)
Name and address of API manufacturer. Vision Pharmaceuticals Pvt. Ltd, Plot No. 22-23,
product.
standard, container closure system and stability studies
of drug substance.
Stability Studies of Drug Substance Real time: 30°C ± 2°C / 65% ± 5%RH for 36 months
(Conditions & duration of Stability studies) Accelerated: 40°C ± 2°C / 75% ± 5%RH for 6 months
Batches: (OMP073,)
development, manufacture, manufacturing process and
process control, process validation protocols, control
of excipients, control of drug product, specifications,
Dissolution Profile equivalence for their product against Risek 20mg
capsule by performing quality tests (appearance,
identification, dissolution, assay)
product studies including specificity, linearity, range,
accuracy, precision (repeatability), system suitability.
Manufacturer of API Vision Pharmaceuticals Pvt. Ltd, Plot No. 22-23, Industrial Triangle Kahuta Road
Islamabad.
API Lot No. OMP1199
Description of Pack Alu-Alu Blister packed in unit carton 2x7’s
No. of Batches 03
1. Reference of previous approval of applications with No reference is submitted by the firm
2. Approval of API/ DML/GMP certificate of API The firm have submitted cGMP certificate of M/s
manufacturer issued by concerned regulatory Vision Pharmaceuticals issued on 22-08-2022 based on
3. Documents for the procurement of API with approval No document submitted
4. Data of stability batches will be supported by attested Firms has submitted data of stability batches supported
and accelerated)
2.3.R.1  Justification is required for using 2% overage in finished product as mentioned in 
BMR
 Justification shall be submitted for the dispensed quantity of Omeprazole pellets
against the label claim with reference to the potency of Omeprazole pellets determined
during drug substance analysis by M/s Qadir Pharma.
3.2.S.4  Copies of the Drug substance specifications and analytical procedures used for routine 
testing of the Drug substance 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
 Justification shall be submitted for incomplete testing of drug substance by drug
product manufacturer as recommended by drug substance manufacturer (loss on
drying, sugar test, pellet size, bulk density).
 Clarification shall be submitted regarding declared the potency of Omeprazole pellets
determined during drug substance analysis by M/s Qadir Pharma whether it is on “as
is basis” or “anhydrous basis”.
3.2.S.7  Stability study of at least three batches of drug substance till claimed shelf life shall be 
submitted
3.2.P.2  Submit the details of manufacturer, batch No# and expiry date of 
innovator/reference/comparator product against which pharmaceutical equivalence
studies have been performed
 Justify why the pharmaceutical equivalence study does not include complete testing
of the drug product and the comparator product including the tests recommended by
USP (uniformity of dosage units).
 Justification is required since pharmaceutical equivalence have not been conducted
against the innovator product.
 Submit CDP studies of applied product as per guidelines approved by the registration
board in its 293rd meeting
3.2.P.5  Justification is required for not including the test for uniformity of dosage units in 
finished product specifications as recommended by USP.
 Justification is required for not mentioning the test number and time for dissolution
test in finished product specifications at buffer stage as recommended by USP.
 Signed copies of the Drug product analytical procedures used for routine testing of the
Drug product by Drug Product manufacturer is required from M.s Qadir
Pharmaceuticals instead of referring to the USP monograph extract.
3.2.P.8  The batch number of manufactured batches mentioned in BMR is CTR001, CTR002, 
CTR003 while batch number mentioned stability summary sheet is T001, T002, T003,
clarify
 Justification is required since results of dissolution test in stability summary sheets at
acid stage of batch No#T001 Accelerated conditions at 6 th month time point, T002
Accelerated conditions at 6th month time point, T003 real time conditions at 3rd and 6th
month time point show results in terms of negative percentage.
 Justification shall be submitted for performing the dissolution test at acid stage on
HPLC and at buffer stage on UV spectrophotometer in stability studies
 Clarification shall be submitted regarding the calculation formula applied for the
results of Acid stage dissolution test with reference to the USP monograph since firm
has represented the dissolution results as more than 90% in raw data sheets of acid
stage dissolution test and has further subtracted results of dissolution test at acid stage
from assay test for calculating final results.
 Submit document for procurement of API.
Previous Decision (M-327-DRB): Registration Board deferred the case for submission of reply to the above cited
shortcomings.
Firm’s Response:
2.3.R.1  Justification is required for using 2%  Firm submitted that No overage has been used in the
overage in finished product as mentioned in formulation of finished product
BMR  In the BMR 240mg of omeprazole pellets has been
 Justification shall be submitted for the used equivalent to 20mg of omeprazole on the basis
dispensed quantity of Omeprazole pellets of assay analysis by M/S Qadir pharmaceuticals i.e.
against the label claim with reference to the 8.33% (on as is basis). COA of manufacturer of drug
potency of Omeprazole pellets determined substance and drug product manufacturer are
during drug substance analysis by M/s Qadir submitted.
Pharma.
3.2.S.4  Copies of the Drug substance specifications  Copies of the Drug substance specifications and
and analytical procedures used for routine analytical procedures used for routine testing of the
testing of the Drug substance by Drug Drug substance by Drug Product manufacturer is
Product manufacturer is required. not submitted.
by the Drug Product manufacturer for drug manufacturer for drug substance is not submitted.
substance(s) shall be submitted.  Firm has submitted revised batch analysis report of
 Justification shall be submitted for drug substance by drug product manufacturer in
incomplete testing of drug substance by drug which complete testing has been performed
product manufacturer as recommended by including loss on drying, sugar test, pellet size, bulk
drug substance manufacturer (loss on density.
drying, sugar test, pellet size, bulk density).  Firm has submitted COA of drug substance wherein
 Clarification shall be submitted regarding potency of omeprazole has been calculated on “as is
declared the potency of Omeprazole pellets basis”.
determined during drug substance analysis
by M/s Qadir Pharma whether it is on “as is
basis” or “anhydrous basis”.
3.2.S.7  Stability study of at least three batches of Firm has submitted stability study data of only one
drug substance till claimed shelf life shall be batch of drug substance at accelerated and real time
submitted conditions:
3.2.P.2  Submit the details of manufacturer, batch  Firm has provided details on innovator product
No# and expiry date of against which pharmaceutical equivalence studies
innovator/reference/comparator product have been performed
against which pharmaceutical equivalence Losec 20mg capsule (Astra Zenenca) Barret hodgson
studies have been performed Pakistan (Pvt) Ltd
 Justify why the pharmaceutical equivalence Lot No; YEWH
study does not include complete testing of Mfg. Date; 02-2022
the drug product and the comparator product Exp. Date: 01-2025
including the tests recommended by USP  Firm has submitted revised pharmaceutical
(uniformity of dosage units). equivalence report for their product against Losec
 Justification is required since 20mg capsule by M/s Barret Hodgson Pakistan (Pvt)
pharmaceutical equivalence have not been Ltd by performing quality tests (appearance,
conducted against the innovator product. identification, average weight, uniformity of dosage
 Submit CDP studies of applied product as unit, dissolution, assay)
per guidelines approved by the registration  Firm has submitted CDP studies against the product
board in its 293rd meeting Losec 20mg capsule by M/s Barret Hodgson
Pakistan (Pvt) Ltd in 0.1N HCl (pH 1.2) &
Phosphate Buffer (pH 6.8). The values for f2 are in
3.2.P.5  Justification is required for not including the  Firm has submitted revised finished product
test for uniformity of dosage units in specifications containing the test for uniformity of
finished product specifications as dosage units and time for dissolution test at buffer
recommended by USP. stage.
 Justification is required for not mentioning  Firm has referred to USP dissolution test 2 in
the test number and time for dissolution test analytical procedure.
in finished product specifications at buffer  Unsigned Copies of the Drug product analytical
stage as recommended by USP. procedures used for routine testing of the Drug
 Signed copies of the Drug product analytical product by Drug Product manufacturer is submitted
procedures used for routine testing of the
Drug product by Drug Product manufacturer
is required from M.s Qadir Pharmaceuticals
instead of referring to the USP monograph
extract.
3.2.P.8  The batch number of manufactured batches  The firm submitted that previously T001, T002 and
mentioned in BMR is CTR001, CTR002, T003 was used for all product that is why in stability
CTR003 while batch number mentioned sheet it is same while later on from R & D and
stability summary sheet is T001, T002, production department for all dosage form a
T003, clarify different batch series was introduced e.g. for capsule
 Justification is required since results of it is CTR001, for tablet it is TTR001 and liquid
dissolution test in stability summary sheets syrup it is LS001. As the stability sheet data of
at acid stage of batch No#T001 Accelerated HPLC cannot be changed therefore it is requested to
conditions at 6th month time point, T002 please allow us to change the BMR Batch no.
Accelerated conditions at 6th month time  The calculation in the raw data sheet is incorrect.
point, T003 real time conditions at 3rd and 6th The undissolved pellets of acid stage were dissolved
month time point show results in terms of in the diluent and give a result more than 90%. So
negative percentage. 100- dissolved %= Release in acid stage
 Justification shall be submitted for  The dissolution test 2 of USP 43 is followed in the
performing the dissolution test at acid stage stability studies which clearly indicate the buffer
on HPLC and at buffer stage on UV stage analysis that “Determine the amount of
spectrophotometer in stability studies omeprazole dissolved from UV absorbances at the
 Clarification shall be submitted regarding wavelength of maximum absorbance at about 305
the calculation formula applied for the nm” that is why acid stage is analyzed by HPLC and
results of Acid stage dissolution test with buffer by UV.
reference to the USP monograph since firm  This is as given in USP Dissolution test 2 “Sample
has represented the dissolution results as solution: After 2 h, remove each sample from the
more than 90% in raw data sheets of acid basket, and quantitatively transfer into separate
stage dissolution test and has further volumetric flasks to obtain a solution having a final
subtracted results of dissolution test at acid concentration of about 0.2 mg/mL. Proceed as
stage from assay test for calculating final directed for the Sample solution in the Assay,
results. starting with “Add about 50 mL of Diluent ”
 Submit document for procurement of API.  Add about 50 mL of Diluent, and sonicate for 15
min. Cool, dilute with Diluent to volume, mix, and
pass through a membrane filter of 0.45-µm or finer
pore size. [NOTE— Bubbles may form just before
bringing the solution to volume. Add a few drops of
dehydrated alcohol to dissipate the bubbles if they
persist for more than a few minutes.
 The undissolved pellets of acid stage were dissolved
in the diluent and give a result more than 90%. So
100- dissolved %= Release in acid stage
 No document for procurement of API is submitted
 Justification for using overage in finished product as mentioned in BMR
 Copies of the Drug substance specifications and analytical procedures used for routine testing of the
Drug substance by Drug Product manufacturer
 Analytical Method Verification studies including specificity, accuracy and repeatability (method
precision) performed by the Drug Product manufacturer for drug substance
 Stability study of at least three batches of drug substance till claimed shelf life
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
 Signed copies of the Drug product analytical procedures used for routine testing of the Drug product
by Drug Product manufacturer
 Scientific justification for the calculation of dissolution test with reference to the pharmacopoeia
monograph.
 Documents for procurement of API with approval from DRAP
722. Name, address of Applicant / Mar keting M/s Qadir Pharmaceuticals, Veerum Fateh Garh
Authorization Holder Sahuwala Road, Sialkot.
Name, address of Manufacturing site. M/s Qadir Pharmaceuticals, Veerum Fateh Garh
Sahuwala Road, Sialkot.
☐ Importer
GMP status of the firm Firm has been granted new license (DML No. 000944)
Evidence of approval of manufacturing facility Firm has submitted copy of letter of issuance of DML
dated 17-09-2021 which specifies Capsule (General)
section.
☐ Export sale
Dy. No. and date of submission Dy. No. 5904 : 02/03/2023
Details of fee submitted PKR 30,000/-: 07/12/2022
The proposed proprietary name / brand name Praq 40mg Capsule
Strength / concentration of drug of Active Each Hard gelatine capsule contains:
Pharmaceutical ingredient (API) per unit Enteric coated pellets (22.5%) of omeprazole
equivalent to omeprazole …….40mg
Pharmaceutical form of applied drug Hard gelatine capsule
The status in reference regulatory authorities Omeprazole 40mg gastro-resistant capsules MHRA
Approved
For generic drugs (me-too status) Risek Capsule 40mg by M/s Getz Pharma
(Reg#22109)
Name and address of API manufacturer. Vision Pharmaceuticals Pvt. Ltd, Plot No. 22-23,
product.
of drug substance.
Stability Studies of Drug Substance Real time: 30°C ± 2°C / 65% ± 5%RH for 36 months
(Conditions & duration of Stability studies) Accelerated: 40°C ± 2°C / 75% ± 5%RH for 6 months
Batches: (OMP065, OMP103, OMP083)
process control, process validation protocols, control
of excipients, control of drug product, specifications,
Dissolution Profile equivalence for their product against Risek 40mg
capsule by performing quality tests (appearance,
identification, dissolution, assay)
product studies including specificity, linearity, range,
accuracy, precision (repeatability), system suitability.
Manufacturer of API Vision Pharmaceuticals Pvt. Ltd, Plot No. 22-23, Industrial Triangle Kahuta Road
Islamabad.
API Lot No. OMP896
Description of Pack Alu-Alu Blister packed in unit carton 2x7’s
No. of Batches 03
1. Reference of previous approval of applications with No reference is submitted by the firm
2. Approval of API/ DML/GMP certificate of API The firm have submitted cGMP certificate of M/s
manufacturer issued by concerned regulatory Vision Pharmaceuticals issued on 22-08-2022 based on
3. Documents for the procurement of API with approval No document submitted
4. Data of stability batches will be supported by attested Firms has submitted data of stability batches supported
5. Compliance Record of HPLC software 21CFR & The firm submitted that our system is not 21 CFR
audit trail reports on product testing compliant and audit trail reports on product testing is
not submitted
and accelerated)
2.3.R.1  Justification is required for using 1.25% overage in finished product as mentioned in 
BMR
 Justification shall be submitted for the dispensed quantity of Omeprazole pellets against
the label claim with reference to the potency of Omeprazole pellets determined during
drug substance analysis by M/s Qadir Pharma.
 Analytical Method Verification studies including specificity, accuracy and repeatability
(method precision) performed by the Drug Product manufacturer for drug substance(s)
shall be submitted.
 Justification shall be submitted for incomplete testing of drug substance by drug
product manufacturer as recommended by drug substance manufacturer (loss on drying,
sugar test, pellet size, bulk density).
 Clarification shall be submitted regarding declared the potency of Omeprazole pellets
determined during drug substance analysis by M/s Qadir Pharma whether it is on “as is
basis” or “anhydrous basis”.
3.2.P.2  Submit the details of manufacturer, batch No# and expiry date of 
innovator/reference/comparator product against which pharmaceutical equivalence
studies have been performed
 Justify why the pharmaceutical equivalence study does not include complete testing of
the drug product and the comparator product including the tests recommended by USP
(uniformity of dosage units).
 Justification is required since pharmaceutical equivalence have not been conducted
against the innovator product.
 Submit CDP studies of applied product as per guidelines approved by the registration
board in its 293rd meeting
3.2.P.5  Justification is required for not including the test for uniformity of dosage units in 
finished product specifications as recommended by USP.
 Justification is required for not mentioning the test number and time for dissolution test
in finished product specifications at buffer stage as recommended by USP.
 Signed copies of the Drug product analytical procedures used for routine testing of the
Drug product by Drug Product manufacturer is required from M.s Qadir
Pharmaceuticals instead of referring to the USP monograph extract.
3.2.P.8  The batch number of manufactured batches mentioned in BMR is CTR001, CTR002, 
CTR003 while batch number mentioned stability summary sheet is T001, T002, T003,
clarify
 Justification is required since results of dissolution test in stability summary sheets at
acid stage of batch No#T003 Accelerated conditions at 3 rd month time point show
results in terms of negative percentage.
 Justification shall be submitted for performing the dissolution test at acid stage on
HPLC and at buffer stage on UV spectrophotometer in stability studies
 Clarification shall be submitted regarding the calculation formula applied for the results
of Acid stage dissolution test with reference to the USP monograph since firm has
represented the dissolution results as more than 90% in raw data sheets of acid stage
dissolution test and has further subtracted results of dissolution test at acid stage from
assay test for calculating final results.
 Submit document for procurement of API.
shortcomings.
Firm’s Response:
2.3.R.1  Justification is required for using 1.25% overage  Firm submitted that No overage has been used
in finished product as mentioned in BMR in the formulation of finished product
 Justification shall be submitted for the dispensed  In the BMR 180mg of omeprazole pellets has
quantity of Omeprazole pellets against the label been used equivalent to 40mg of omeprazole on
claim with reference to the potency of the basis of assay analysis by M/S Qadir
Omeprazole pellets determined during drug pharmaceuticals i.e. 22.5% (on as is basis).
substance analysis by M/s Qadir Pharma. COA of manufacturer of drug substance and
drug product manufacturer are submitted.
analytical procedures used for routine testing of and analytical procedures used for routine
the Drug substance by Drug Product testing of the Drug substance by Drug Product
manufacturer is required. manufacturer is not submitted.
 Analytical Method Verification studies  Analytical Method Verification studies
including specificity, accuracy and repeatability including specificity, accuracy and
(method precision) performed by the Drug repeatability (method precision) performed by
Product manufacturer for drug substance(s) shall the Drug Product manufacturer for drug
be submitted. substance is not submitted.
 Justification shall be submitted for incomplete  Firm has submitted revised batch analysis
testing of drug substance by drug product report of drug substance by drug product
manufacturer as recommended by drug manufacturer in which complete testing has
substance manufacturer (loss on drying, sugar been performed including loss on drying, sugar
test, pellet size, bulk density). test, pellet size, bulk density.
 Clarification shall be submitted regarding  Firm has submitted COA of drug substance
declared the potency of Omeprazole pellets wherein potency of omeprazole has been
determined during drug substance analysis by calculated on “as is basis”.
M/s Qadir Pharma whether it is on “as is basis”
or “anhydrous basis”.
3.2.P.2  Submit the details of manufacturer, batch No#  Firm has provided details of comparator
and expiry date of product against which pharmaceutical
innovator/reference/comparator product against equivalence studies have been performed
which pharmaceutical equivalence studies have Risek 40mg capsule by M/s Getz (Pvt) Ltd
been performed Lot No; C04059
 Justify why the pharmaceutical equivalence Mfg. Date; 02-2022
study does not include complete testing of the Exp. Date: 02-2025
drug product and the comparator product
including the tests recommended by USP  The firm submitted due to unavailability of
(uniformity of dosage units). Losec 40mg capsule in Pakistan Risek 40mg
 Justification is required since pharmaceutical was used as comparator for Pharmaceutical
equivalence have not been conducted against the equivalence and CDP studies.
innovator product.  Firm has submitted revised pharmaceutical
 Submit CDP studies of applied product as per equivalence report for their product against
guidelines approved by the registration board in Risek 40mg capsule by M/s Getz (Pvt) Ltd by
its 293rd meeting performing quality tests (appearance,
identification, average weight, uniformity of
dosage unit, dissolution, assay)
 Firm has submitted CDP studies against the
product Risek 40mg capsule by M/s Getz (Pvt)
Ltd in 0.1N HCl (pH 1.2) & Phosphate Buffer
(pH 6.8). The values for f2 are in the acceptable
range.
3.2.P.5  Justification is required for not including the test  Firm has submitted revised finished product
for uniformity of dosage units in finished specifications containing the test for uniformity
product specifications as recommended by USP. of dosage units and time for dissolution test at
 Justification is required for not mentioning the buffer stage.
test number and time for dissolution test in  Firm has referred to USP dissolution test 2 in
finished product specifications at buffer stage as analytical procedure.
recommended by USP.  Unsigned Copies of the Drug product analytical
 Signed copies of the Drug product analytical procedures used for routine testing of the Drug
procedures used for routine testing of the Drug product by Drug Product manufacturer is
product by Drug Product manufacturer is submitted
required from M.s Qadir Pharmaceuticals
instead of referring to the USP monograph
extract.
3.2.P.8  The batch number of manufactured batches  The firm submitted that previously T001, T002
mentioned in BMR is CTR001, CTR002, and T003 was used for all product that is why in
CTR003 while batch number mentioned stability stability sheet it is same while later on from R
summary sheet is T001, T002, T003, clarify & D and production department for all dosage
 Justification is required since results of form a different batch series was introduced e.g.
dissolution test in stability summary sheets at for capsule it is CTR001, for tablet it is TTR001
acid stage of batch No#T003 Accelerated and liquid syrup it is LS001. As the stability
conditions at 3rd month time point show results sheet data of HPLC cannot be changed therefore
in terms of negative percentage. it is requested to please allow us to change the
 Justification shall be submitted for performing BMR Batch no.
the dissolution test at acid stage on HPLC and at  The calculation in the raw data sheet is
buffer stage on UV spectrophotometer in incorrect. The undissolved pellets of acid stage
stability studies were dissolved in the diluent and give a result
 Clarification shall be submitted regarding the more than 90%. So 100- dissolved %= Release
calculation formula applied for the results of in acid stage
Acid stage dissolution test with reference to the  The dissolution test 2 of USP 43 is followed in
USP monograph since firm has represented the the stability studies which clearly indicate the
dissolution results as more than 90% in raw data buffer stage analysis that “Determine the
sheets of acid stage dissolution test and has amount of omeprazole dissolved from UV
further subtracted results of dissolution test at absorbances at the wavelength of maximum
acid stage from assay test for calculating final absorbance at about 305 nm” that is why acid
results. stage is analyzed by HPLC and buffer by UV.
 Submit document for procurement of API.  This is as given in USP Dissolution test 2
“Sample solution: After 2 h, remove each
sample from the basket, and quantitatively
transfer into separate volumetric flasks to obtain
a solution having a final concentration of about
0.2 mg/mL. Proceed as directed for the Sample
solution in the Assay, starting with “Add about
50 mL of Diluent ”
 Add about 50 mL of Diluent, and sonicate for
15 min. Cool, dilute with Diluent to volume,
mix, and pass through a membrane filter of
0.45-µm or finer pore size. [NOTE— Bubbles
may form just before bringing the solution to
volume. Add a few drops of dehydrated alcohol
to dissipate the bubbles if they persist for more
than a few minutes. ]
 The undissolved pellets of acid stage were
dissolved in the diluent and give a result more
than 90%. So 100- dissolved %= Release in acid
stage
 No document for procurement of API is
submitted
 Justification for using overage in finished product as mentioned in BMR
Drug substance by Drug Product manufacturer
 Stability study of at least three batches of drug substance till claimed shelf life
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
 Signed copies of the Drug product analytical procedures used for routine testing of the Drug product
by Drug Product manufacturer
 Scientific justification for the calculation of dissolution test with reference to the pharmacopoeia
monograph.
 Documents for procurement of API with approval from DRAP
Case No. 08: Deferred Registration applications of Human drugs on Form 5-F (New Section)
M/s Titlis Pharma, Plot No. 528-A, Sundar Industrial Estate, Raiwand Road, Lahore
The Central Licensing Board in its 285th meeting held on 17th & 18th March, 2022 has considered and
approved the grant of following sections of M/s Titlis Pharma, Plot No. 528-A, Sundar Industrial Estate,
Raiwand Road, Lahore under Drug Manufacturing License No. 000779 (Formulation) vide approval letter
No. F. 1-11/2009-Lic (Vol-I) dated 10th May, 2022.
S No. Section
1. Tablet Section II (General) New
2. Dry Powder Suspension Section. New
3. Dry Powder Sachet Section (General). New

723. Name, address of Applicant / Marketing M/s Titlis Pharma (Pvt.) Limited., 528-A, Sunder
Authorization Holder Industrial Estate, Raiwind Road, Lahore.
Name, address of Manufacturing site. M/s Titlis Pharma (Pvt) Limited., 528-A, Sunder
Industrial Estate, Raiwind Road, Lahore.
☐ Importer
☐ Export sale
(Slip#1900631731)
The proposed proprietary name / brand name Montit 4mg Sachet
Strength / concentration of drug of Active Each Sachet contain
Pharmaceutical ingredient (API) per unit Montelukast Sodium equivalent to Montelukast
…….4mg
Pharmaceutical form of applied drug Sachet
Pharmacotherapeutic Group of (API) Leukotriene receptor antagonists (LTRAs)
The status in reference regulatory authorities Montelukast 4 mg Granules MHRA Approved
For generic drugs (me-too status) Montika 4mg Sachet by M/s Sami Pharmaceuticals
(Reg#50744)
GMP status of the Finished product New section granted on 17th & 18th March, 2022 and letter
manufacturer issued on 10th May, 2022
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
Summarized information related to nomenclature,
structure, general properties, Solubilities, physical form,
manufacturers, specifications, analytical procedures and
manufacturers, specifications, analytical procedures,
batch analysis and justification of specification, container
closure system and stability studies of drug substance
Batches: (201310301, 201310302, 201310303)
specifications, analytical procedure and its verification
dissolution profile against Montiget Sachet 4mg of M/s Getz Pharma by
performing quality tests (weight variation, Assay,
Dissolution, of dosage form).
product 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. 11001-210505
Description of Pack Aluminum foil (three layer) sachet packet packed in cardboard carton.
Batch No. MT-01 MT-02 MT-03
Batch Size 200 sachet 200 sachet 200 sachet
Manufacturing Date Nov-2021 Nov-2021 Nov-2021
No. of Batches 03
1. Reference of previous approval of applications Not submitted
2. Approval of API/ DML/GMP certificate of API The firm has submitted copy of GMP Certificate No.
manufacturer issued by concerned regulatory ZJ20180033 of M/s Zhejiang Tianyu Pharmaceutical Co.,
authority of country of origin. Ltd., No.15, Donghai 5th Avenue, Zhejiang Provincial
Chemical and Medical Raw Materials Base Linhai Zone,
Taizhou City, Zhejiang Province, China issued by China
Food and Drug Administration valid till 14-03-2023
3. Documents for the procurement of API with Firm has submitted copy of invoice No# TY121643 dated
approval from DRAP (in case of import). 12th July 2021 in the name of M/s Titlis Pharma Lahore
from M/s Zhejiang Tianyu Pharmaceutical Co., Ltd., for
import of 20kg Montelukast Sodium Batch No# 11001-
210505. However the invoice is not attested by AD (I&E)
DRAP field office
4. Data of stability batches will be supported by Firm has submitted data of stability batches supported by
attested respective documents like attested respective documents like chromatograms, Raw
chromatograms, Raw data sheets, COA, data sheets, COA, summary data sheets etc.
5. Compliance Record of HPLC software 21CFR Not submitted
6. Record of Digital data logger for temperature Firm has submitted Record of Digital data logger for
and humidity monitoring of stability chambers temperature and humidity monitoring of stability
(real time and accelerated) chambers (accelerated)
XI
1.3.2  The name of applicant as per form 5F is M/s Titlis Pharma (Pvt.) Limited., while
name mentioned on DML is M/s Titlis Pharma., Clarification is required
3.2.S.4  Justification is required for not including the test for enantiomeric purity in drug substance
specification by drug product manufacturer as recommended by USP.
 Firm have used isocratic method for assay test with mobile phase composition of solution A
and solution B (40:60) while USP recommends gradient method
 Analytical Method Verification studies including specificity, accuracy and repeatability
(method precision) performed by the Drug Product manufacturer for drug substance(s) shall
be submitted.
 Submit readable copy of Certificate of Analysis of the same batch of drug substance used
during product development and stability studies from Drug Substance manufacturer.
3.2.S.5  COA of primary / secondary reference standard including source and lot number
shall be provided.
3.2.P.2  Justify the difference in qualitative composition of applied product from that of
reference / innovator product.
Applied product Montelukast 4 mg
Granules
Montelukast sodium Montelukast sodium
Dextrose Mannitol
Hydroxy propyl
cellulose
Tribasic sodium
phosphate
Magnesium Stearate
 Justify why Pharmaceutical equivalence of the applied product has not been
performed against the innovator product?
 CDP of the applied product has not been submitted.
 Only protocol for CDP is submitted
3.2.P.5  Clarification is required as the method of preparation and concentration of standard solution
in analytical method of dissolution test is different from USP.
 Firm have used isocratic method for assay test with mobile phase composition of solution A
3.2.P.6  Clarification is required since the submitted COA of reference / working

standard states that it follows in house specifications while the product
monograph is available in USP
3.2.P.8  Submit DRAP attested documents for the procurement of API.
 Submit Record of Digital data logger for temperature and humidity monitoring
of stability chambers (real time conditions)
Previous Decision (M-323rd –RB (6th -8th December 2022) (Publication date of Minutes; 10 th January 2023):
Firm’s Response (6th June 2023):
1.3.2  The name of applicant as per form 5F is The firm submitted that the title of our company
M/s Titlis Pharma (Pvt.) Limited., while has been changed in 279th meeting of Central
name mentioned on DML is M/s Titlis Licensing Board held on 18th February 2021, and
Pharma., Clarification is required the new approved title is “Titlis Pharma (Private)
Limited”. The change of title approval letter No.
F. 1-11/2009-Lic (Vol-I) from Central Licensing
Board in the name of “Titlis Pharma (Private)
Limited” is submitted.
3.2.S.4  Justification is required for not including  The firm submitted that we have imported
the test for enantiomeric purity in drug Montelukast Sodium from Zhejiang Tianyu
substance specification by drug product Pharmaceutical Co., Ltd, which is well reputed
manufacturer as recommended by USP. API manufacturer and supplying its
 Analytical Method Verification studies Montelukast Sodium to leading companies of
including specificity, accuracy and Pakistan like Highnoon Laboratories, CCL
repeatability (method precision) Pharmaceuticals, Sami Pharmaceuticals, Getz
performed by the Drug Product Pharma, and The Searle Company limited.
manufacturer for drug substance(s) shall Our API manufacturer Zhejiang Tianyu
be submitted. Pharmaceutical Co., Ltd has performed the test
 Submit readable copy of Certificate of for Enantiomeric purity and we rely on our API
Analysis of the same batch of drug Manufacturer for Enantiomeric purity test.
substance used during product
(COA of Drug Substance Manufacturer is
development and stability studies from
Drug Substance manufacturer. attached for reference).
 Analytical Method Verification studies
including specificity, accuracy and
repeatability (method precision) performed by
the Drug Product manufacturer for drug
substance is submitted.
 Readable copy of Certificate of Analysis of the
same batch of drug substance used during
product development and stability studies from
Drug Substance manufacturer is submitted.
3.2.S.4  Firm have used isocratic method for assay test with mobile phase composition of solution A
Firm’s Response:
 The firm submitted that we have revised our testing method and now implemented the gradient
method for assay testing truly according to the USP (revised method is submitted)
 We have also tested the API as per our revised method. (Revised method and chromatogram
are submitted).
3.2.S.5  COA of primary / secondary reference Copy of Certificate of analysis of primary /
standard including source and lot number secondary reference standard is submitted.
shall be provided.
3.2.P.2  Justify the difference in qualitative  The firm submitted that as per literature review,
composition of applied product from that it is notable that the active ingredient and all the
of reference / innovator product. excipients used in our formulation are inert, and
Applied product Montelukast 4 mg are compatible with active pharmaceutical
Granules ingredient of Montit sachet 4mg. Moreover,
Montelukast Montelukast their safety and compatibility have also been
sodium sodium established as no harsh effect has been
Dextrose Mannitol observed in our stability studies.
Hydroxy propyl  The firm further stated that we have also
cellulose performed Drug Excipients Compatibility
Tribasic sodium studies, which concludes that all the excipients
phosphate are inert and has no harsh effect on product
Magnesium stability (Reports are submitted).
Stearate  The firm submitted that as the innovator
 Justify why Pharmaceutical equivalence product is not registered in Pakistan therefore,
of the applied product has not been Pharmaceutical equivalence of Montit 4mg
performed against the innovator product? Sachet was performed against the reference
 CDP of the applied product has not been product Montiget 4mg Sachet manufactured by
submitted. Getz Pharma (Private) Limited. (Reports are
 Only protocol for CDP is submitted submitted).
 As the innovator product is not registered in
Pakistan therefore, Comparative Dissolution
Profile of Montit 4mg Sachet was performed
against the reference product Montiget 4mg
Sachet manufactured by Getz Pharma (Private)
Limited 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.
(Reports are submitted).
 However, Innovator product singulair 4mg
granules is registered in Pakistan
3.2.P.5  Clarification is required as the method of  The firm submitted that method of preparation
preparation and concentration of standard and concentration of standard solution in
solution in analytical method of analytical method of dissolution test is same per
dissolution test is different from USP. USP. There was a typographic error in already
submitted method. However, the calculation
sheet was accurately same as that of USP
method. Moreover, we have also revised our
testing method and the revised method is
submitted.
 However the concentration of standard
solution in dissolution test is still not as per
USP monograph and firm have submitted
details of dissolution test 1 in reply while in
original dossier it was dissolution test 3.
3.2.P.5  Firm have used isocratic method for assay test with mobile phase composition of solution A
Firm’s Response:
 The firm submitted that we have revised our testing method by using gradient method for
assay testing truly according to the USP (revised method is submitted)
 Moreover, we have manufactured 3 new batches (Batch numbers: MT-04, MT-05 and MT-
06) and performed accelerated and long run stability testing by using gradient method for
assay testing truly according to the USP, “0”, & 3 rd month testing has been completed and
results are complying the specs. (Reports and chromatograms are submitted)
Batch No. MT-04 MT-05 MT-06
Manufacturing 12-2022 12-2022 12-2022
Date
3.2.P.6  Clarification is required since the The firm submitted that we have revised our
submitted COA of reference / working testing method and manufactured 3 new batches
standard states that it follows in house (Batch numbers: MT-04, MT-05 and MT-06) for
specifications while the product performance of accelerated and long run stability
monograph is available in USP testing by using gradient method for assay testing
truly according to the USP and “0”, & 3rd month
testing has been completed and results are
complying the Specs.
The firm further stated that we have used the
working standard (Batch No: WRS 20221017)
that complies with the USP Specifications for the
testing of our New Batches. (COA of reference
standard used for testing of our product is
enclosed herewith)
3.2.P.8  Submit DRAP attested documents for the  Firm has submitted copy invoice No.
procurement of API. TY121643 dated 12-07-2021 for import of
 Submit Record of Digital data logger for 20kg Montelukast Sodium in name of M/s
temperature and humidity monitoring of Titlis Pharma attested by AD (I&E) DRAP
stability chambers (real time conditions) Lahore dated 15-07-2021.
at real time conditions is submitted
 Fee of Rs. 30,000/- for revision in stability data as per notification No.F.7-11/2012-B&A/DRAP dated
13-07-2021.
 Clarification as the method of preparation and concentration of standard solution in analytical
method of dissolution test is different from USP monograph.
 Submission of 6th month time point stability data of the newly developed trial batches
Case No. 09: Routine Registration applications of Human drugs on Form 5-F (Local)
724. Name, address of Applicant / Marketing M/s Maxitech Pharma (Pvt) Ltd., Plot No. E-178, S.I.T.E.
Authorization Holder Super Highway, Phase II, Karachi
Name, address of Manufacturing site. M/s Maxitech Pharma (Pvt) Ltd., Plot No. E-178, S.I.T.E.
Super Highway, Phase II, Karachi
☐ Importer
GMP status of the Finished product Firm has submitted copy of routine GMP inspection report
manufacturer dated 07-07-2021 which conclude as:
Based on the stated facts and keeping in view the attitude of
firm towards constant improvements their current GMP
compliance level is rated a GOOD.
Evidence of approval of manufacturing Firm has submitted copy of letter No. F. 2-12/2012-Lic dated
facility 25-11-2016 which specifies ointment / cream/ lotion (General)
section
☐ Export sale
Eurisa 2% Ointment
name
Strength / concentration of drug of Each Gram Contains:
Active Pharmaceutical ingredient (API) Crisaborole………………20mg
per unit
Pharmaceutical form of applied drug Topical ointment
Pharmacotherapeutic Group of (API) PDE-4 Inhibitor (Phosphodiesterase-4 inhibitor)
N/A
specifications
Proposed Pack size 10gm, 20gm, 30gm
The status in reference regulatory EUCRISA (crisaborole) 2% (w/w) ointment, USFDA
authorities Approved
EUCRISA Crisaborole Ointment, 2 % Health Canada
Approved
STAQUIS crisaborole 2% w/w ointment TGA Approved
Name and address of API manufacturer. M/s Fujian Jinshan Zhundian Pharmaceutical Co., Ltd.,
Jintang Industry Zone, Shaowu City, Fujian Province China
Module-II (Quality Overall Summary) Not submitted as per requirement
analysis and justification of specification, container closure
(Conditions & duration of Stability Real time: 25 ± 2°C / 60 ± 5% RH) for 24 months
studies) Accelerated: 40 ± 2°C / 75 ± 5% RH for 6 months
Batches: (170101, 170102, 170103)
procedure and its validation studies, batch analysis and
justification of specification, container closure system and
Pharmaceutical equivalence and Pharmaceutical Equivalence have been established against the
comparative dissolution profile brand that is Staquis ointment 2% by M/s Pfizer Pharma USA.
Analytical method validation/verification Firm has submitted method validation studies including
of product Specificity, Linearity, range, Accuracy, Precision-
Repeatability, Intermediate Precision, detection limit,
quantitation limit, Robustness.
Manufacturer of API M/s Fujian Jinshan Zhundian Pharmaceutical Co., Ltd., Jintang Industry Zone,
Shaowu City, Fujian Province China
API Lot No. 191201
Description of Pack
Alu- lined tube packed in unit carton
Stability Storage Condition Real time: 30°C ± 2°C /65%± 5%RH
Accelerated: 40°C ± 2°C / 75%± 5%RH
Batch No. TR-003 TR-004 TR-005
Batch Size 133 tubes 133 tubes 133 tubes
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate Not submitted
of API manufacturer issued by concerned
3. Documents for the procurement of API Firm has submitted copy of form 6 dated 31-01-2020 for import
with approval from DRAP (in case of of 0.5kg of Crisaborole in name of M/s Maxitech Pharma (Pvt)
import). Ltd attested by AD (I&E) DRAP Karachi dated 31-01-2020.
testing
6. Record of Digital data logger for Not submitted
accelerated)
THERAPEUTIC INDICATIONS
EUCRISA is a phosphodiesterase 4 inhibitor indicated for topical treatment of mild to moderate atopic dermatitis in
adult and paediatric patients 3 months of age and older.
1.5.6  Mention the reference specifications of the  No specifications submitted
finished product
1.6.5  Name and address of drug substance  No details submitted in this section
manufacturer along with valid GMP certificate  The firm has submitted copy of cGMP
/ DML issued by relevant regulatory authority certificate of M/s Fujian Jinshan Zhundian
of country of origin is required Pharmaceutical Co., Ltd., Jintang Industry
Zone, Shaowu City, Fujian Province China
issued by China Food and Drug Administration
China valid till 22-02-2021. Firm has
submitted declaration letter from API
manufacturer wherein API manufacturer has
informed that according to regulations of
CFDA that GMP and GSP certification will be
cancelled. The CFDA authority is not issuing
the GMP certificates for now.
2.3  Submit module 2 as per the CTD guidance  Module 2 of form 5F is submitted
document without referring to other modules
2.3.R.1  Provide copy of Batch Manufacturing Record  Firm has submitted copy of Batch
(BMR) for all the batches of drug product for Manufacturing Record (BMR) for all the
which stability studies data is provided in batches of drug product for which stability
Module 3 section 3.2.P.8.3> studies data is provided in Module 3 section
3.2.P.8.3>
 BMR shows pack size 15gm which is different
from that given in proposed pack size in
module 1.
3.2.S.4  Justification is required for not including the  The firm has submitted declaration that
test for polymorphic form and palladium crisaborole manufactured by API manufacturer
content in drug substance specification by is the most stable form i.e., form-I which is
drug substance manufacturer as recommended supported by XRPD spectra. The polymeric
by innovator product review document form identification is part of developmental
 Copies of the Drug substance specifications studies that has been done as per innovator
and analytical procedures used for routine study. No clarification for not including
testing of the Drug substance by Drug product palladium content in drug substance
is required. specification by drug substance manufacturer
 Analytical Method Verification studies is provided
including specificity, accuracy and  Copies of the Drug substance specifications
repeatability (method precision) performed by and analytical procedures used for routine
the Drug Product manufacturer for drug testing of the Drug substance by Drug product
substance shall be submitted. is submitted.
 Provide results of analysis of relevant batch of  Analytical Method Verification studies
Drug Substance performed by Drug Product including specificity, accuracy and
manufacturer used during product repeatability (method precision) performed by
development and stability studies, along with the Drug Product manufacturer for drug
Certificate of Analysis of the same batch from substance is not submitted.
Drug Substance manufacturer  COA of Drug Substance from Drug Product
manufacturer and Drug Substance
manufacturer is provided
3.2.S.7  Submit stability study of drug substance till Stability study of drug substance till claimed
claimed shelf life as per zone-IV-A conditions shelf life as per zone-IV-A conditions is
submitted
Real time: 30 ± 2°C / 65 ± 5% RH) for 24 months
Accelerated: 40 ± 2°C / 75 ± 5% RH for 6
months
 Batches: (190601, 190602, 190603)
3.2.P.2  Justification is required for using 2% overage  The firm submitted that at the time of product
in the formulation development overage was proposed but after
 Submit pharmaceutical equivalence report of detail study it has been reviewed that no
the applied product overage is required and all trial batches were
manufactured without overages.
 Pharmaceutical equivalence report of the
applied product is not submitted
3.2.P.5  Justification is required for not including the  The firm submitted that test for content
test for content uniformity in container, uniformity in container, EDTA, apparent
EDTA, apparent viscosity, package integrity viscosity, package integrity will be
and minimum fill as recommended by implemented on commercial batches and
innovator product review document minimum fill test is already performed at initial
 Justification is required for using different stage. Now included in revised STM.
chromatographic conditions in analytical  Firm has submitted revised testing method
method validation(mobile phase; purified  Assay limits (90-115%) mentioned in COA is
water:ACN:TFA 650ml;350ml;0.5ml) a typographical error. The specification limit is
wavelength 250nm, flow rate 2ml/min, (90-110%) which is mentioned in stability data
column c18, 4.6mmx150mm; injection as well.
volume 10 ul) than that submitted in analytical
procedure (mobile phase A; purified
water:ACN:Acetic acid 950;50;5, Mobile
phase B purified water:ACN:Acetic acid
50;950;5…mix mobile phase A&B 550;450)
wavelength 254nm, flow rate 1ml/min,
column c18, 4.6mmx25cm; 5umpacking,
injection volume 10 ul)
 Assay limits mentioned in finished product
specification is 90-110% while in batch
analysis assay limit is mentioned as 90-115%
clarify?
3.2.P.6  COA of primary / secondary reference  COA of primary / secondary reference
standard including source and lot number shall standard is not submitted
be provided.
3.2.P.8  The retention time of standard and sample  The firm submitted that retention time on 3rd
solution at both accelerated and real time month stability study varied due to the reason
conditions after 3rd month time point is after 11 that column (C18-4.6mmx250mm) used
min while retention time of standard and instead of 150mm length column at that time of
sample solution after 6th month time point is stability testing which causes delay in retention
after 04 min, clarify time
 Record of Digital data logger for temperature  Record of Digital data logger for temperature
and humidity monitoring of stability chambers and humidity monitoring of stability chambers
(real time and accelerated) is required (real time and accelerated) is not submitted
 Submit documents / commercial invoice for  No documents / commercial invoice for the
the procurement of API with approval from procurement of API is submitted
DRAP
 Reference specifications of the finished product
 Details of drug substance manufacturer in section 1.6.5 of module 1 of form 5F
 Clarification as the proposed pack size (15gm) of trial batches is different from that proposed in section
1.5.4 of module 1 form 5-F
 Clarification for not including palladium content in drug substance specification by drug substance
manufacturer
 Pharmaceutical equivalence report of the applied product against the innovator product
 Justification for not including the test for content uniformity in container, EDTA, apparent viscosity,
package integrity and minimum fill in finished product specifications
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
 COA of primary / secondary reference standard including source and lot number
 Scientific justification for using different length column at different time point (3rd month and 6th
month) and stability study conditions.
 Documents for the procurement of API with approval from DRAP
725. Name, address of Applicant / Marketing M/s Welwrd Pharmaceuticals., Plot No#3, Block A, Phase I-
Authorization Holder II, Industrial Estate, Hattar, Haripur
Name, address of Manufacturing site. M/s Welwrd Pharmaceuticals., Plot No#3, Block A, Phase I-
II, Industrial Estate, Hattar, Haripur
☐ Importer
GMP status of the Finished product Firm has submitted GMP certificate dated 08-07-2019 based
manufacturer on inspection conducted on 12-11-2018
Evidence of approval of manufacturing Firm has submitted copy of GMP certificate dated 08-07-2019
facility based on inspection conducted on 12-11-2018 which specifies
Tablet section (General/Antibiotic)
☐ Export sale
(Deposit Slip#675681277631)
Empawrd-M 5/500mg Tablet
name
Active Pharmaceutical ingredient (API) Empagliflozin (In-House)……..……5mg
per unit Metformin HCl (USP)………….…...500mg
Pharmacotherapeutic Group of (API) Combinations of oral blood glucose lowering drugs
Innovator’s specifications
specifications
The status in reference regulatory SYNJARDY (5mg/500mg, 5mg/1000mg, 12.5mg/500mg,
authorities 12.5 mg/1000 mg) film-coated tablet USFDA approved
For generic drugs (me-too status) Xenglu-Met 5/500mg Tablets by M/s Hilton Pharma
(Reg#105290)
M/s Fuxin Long Rui Pharmaceutical Co. Ltd., Fluoride
Industrial park, Fumeng County, Fuxin city, Liaoning
province, 123000, China.
Metformin HCl:
M/s Aarti Drugs Limited., Plot No. 109-D, Mahendra
Industrial Estate Road No.29 Sion (East), Mumbai – 400022,
India
description of manufacturing process and controls, impurities,
description of manufacturing process and controls, batch
substance
(Conditions & duration of Stability Metformin HCl:
studies) Real time: 30°C ± 2°C / 65% ± 5%RH for 36 months
Batches: (MEF/1410029, MEF/1410028, MEF/1410027)
Empagliflozin:
Batches: (20160606, 20161017, 20161219)
manufacturing process and controls, specifications, validation
Pharmaceutical equivalence and Pharmaceutical Equivalence have been established against the
comparative dissolution profile brand that is Empaa-M 5/500mg tablet by M/s Weatherfolds
Pharma by performing quality tests (Identification, Assay,
Dissolution, weight variation).
CDP has been performed against the same brand that is Empaa
M 5/500 mg Tablet by M/s Weatherfolds Pharma in Acid
media (pH 1.2), Acetate Buffer (pH 4.5) & Phosphate Buffer
(pH 6.8).
Analytical method validation/verification Firm has submitted summary of analytical method validation
of product studies including linearity, range, accuracy, precision, LOD,
LOQ.
Fuxin Long Rui Pharmaceutical Co. Ltd., Fluoride Industrial park, Fuxin city, Liaoning
province, 123000, China.
Metformin HCl:
M/s Aarti Drugs Limited., Plot No. 109-D, Mahendra Industrial Estate Road No.29
Sion (East), Mumbai – 400022, India
API Lot No. Metformin HCl:
MEF/18091912
Empagliflozin:
E-20181027-D02-E06-01
Description of Pack Alu-Alu Blister packed in bleech card box
Frequency Accelerated: 0,1, 2, 3, 4, 6 (Months)
Batch No. T-001 T-002 T-003
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate Empagliflozin:
of API manufacturer issued by concerned Firm has submitted copy of GMP certificate in the name of M/s
regulatory authority of country of origin. Fuxin Long Rui Pharmaceutical Co., Ltd, Fluoride Industrial
Park, Fuxin City, Liaoning Province - 123000, China issued by
Fuxin Food and Drug Administration China valid upto 27-09-
2020.
Firm has submitted copy of DML (Certificate# Liao20150233)
in the name of M/s Fuxin Long Rui Pharmaceutical CO., Ltd.,
China valid upto 20-12-2022.
Metformin HCl:
The firm has submitted GMP certificate for M/s Aarti Drugs
Limited., (Unit-II) Plot No. 211 & 213, Road No.2 G.I.D.C.,
Sarigam, Dist.: Valsad, Gujarat State India issued by Food &
Drug Control Administration Gandhinagar India. The
certificate is valid till 09-01-2020
3. Documents for the procurement of API Empagliflozin:
with approval from DRAP (in case of Firm has submitted copy of invoice No. HN190108-C dated
import). 08-01-2019 for import of 0.41Kg of Empagliflozin (Batch No#
E-20181027-D02-E06-01) in name of M/s Welwrd
Pharmaceuticals attested by AD (I&E) DRAP Peshawar dated
23-01-2019.
Firm has also submitted copy of form 6 dated 23-01-2019 for
import of 0.41Kg of Empagliflozin in name of M/s Welwrd
Pharmaceuticals attested by AD (I&E) DRAP Peshawar dated
23-01-2019.
Metformin HCl:
Firm has submitted copy of invoice No. EXP/1678/18-19 dated
21-11-2018 for import of 500Kg of Metformin HCl (Batch No#
MEF/18091912) in name of M/s Welwrd Pharmaceuticals
attested by AD (I&E) DRAP Peshawar dated 05-12-2018.
by attested respective documents like attested respective documents like chromatograms, summary
chromatograms, Raw data sheets, COA, data sheets etc. Raw data sheets and COAs are not submitted
testing
accelerated)
Section Observations
1.3.5  GMP inspection report/ GMP certificate of the  Firm has submitted copy of cGMP certificate
manufacturing unit issued within the last three issued on 10-06-2022 based on inspection
years shall be submitted conducted on 30-03-2022
1.4.1.  The applied drug product is a generic drug  Firm has corrected the application type in form
product while you have applied for a new drug 5F as Generic drug product
product, clarify
1.6.5  Valid GMP certificate / DML of drug Empagliflozin:
substance manufacturer for Empagliflozin and The firm has submitted written confirmation for
Metformin issued by relevant regulatory active substance exported to EU to M/s Fuxin
authority of country of origin is required Long Rui Pharmaceutical Co., Ltd, China for
 Address of M/s Aarti drugs Limited in Active substance Empagliflozin confirming that
submitted application is different than that the manufacturing plant complies with
mentioned in GMP certificate, clarify requirement of Chinese Good Manufacturing
practices. This certificate is valid till 25-05-2024
Firm has also submitted copy of DML
(License#Liao20150233) of M/s Fuxin Long Rui
Pharmaceutical Co., Ltd, China valid upto 17-11-
2027 verified from NMPA website.
Metformin HCl:
The firm has submitted GMP certificate for M/s
Aarti Drugs Limited., (Unit-II) Plot No. 211 &
213, Road No.2 G.I.D.C., Sarigam, Dist.: Valsad,
Gujarat State India issued by Food & Drug
Control Administration Gandhinagar India. The
certificate is valid till 19-03-2023
2.3.R.1  Provide copy of Batch Manufacturing Record  Firm has submitted copy of Batch
(BMR) for all the batches of drug product for Manufacturing Record (BMR) for all the
which stability studies data is provided in batches of drug product for which stability
Module 3 section 3.2.P.8.3> studies data is provided in Module 3 section
3.2.P.8.3>
3.2.S.3  Submit details in this section as per the  Details in this section are submitted as per
guidance document guidance document
3.2.S.4  Copies of the Drug substance analytical  Copies of the Drug substance analytical
procedures used for routine testing of the Drug procedures used for routine testing of the Drug
Substance Metformin HCl by drug substance Substance Metformin HCl by drug substance
manufacturer is required. manufacturer is not submitted.
 Copies of the Drug substance specifications  Copies of the Drug substance specifications
and analytical procedures used for routine and analytical procedures used for routine
testing of the Drug Substance Metformin HCl testing of the Drug Substance Metformin HCl
by Drug Product manufacturer is required. by Drug Product manufacturer is not submitted.
 Copies of the Drug substance specifications  Copies of the Drug substance specifications
and analytical procedures used for routine and analytical procedures used for routine
testing of the Drug Substance Empagliflozin by testing of the Drug Substance Empagliflozin by
Drug Product manufacturer is required. Drug Product manufacturer is not submitted.
 Analytical Method Verification studies  Analytical Method Verification studies
including specificity, accuracy and including specificity, accuracy and
repeatability (method precision) performed by repeatability (method precision) performed by
the Drug Product manufacturer for drug the Drug Product manufacturer for drug
substance Metformin HCl and Empagliflozin substance Metformin HCl and Empagliflozin is
shall be submitted. submitted
 Clarification is required as the drug substance  No response submitted
manufacturer has performed assay of drug  No response submitted
substance Metformin HCl in batch analysis by  No response submitted
potentiometric method instead of HPLC  Certificate of Analysis of the relevant batch of
method as recommended by USP. Drug Substance used during product
 Justification is required for not performing test development and stability studies from Drug
for identification (IR & Reaction of Chloride) Substance manufacturer is submitted.
and residue on ignition for drug substance However, the batch No# (MEF/19040649) of
metformin HCl in batch analysis by drug Metformin HCl is different from that mentioned
product manufacturer as recommended by USP in batch analysis of drug product manufacturer.
 Justification is required for not performing test
for identification and residue on ignition for
drug substance empagliflozin in batch analysis
by drug product manufacturer as recommended
by drug substance manufacturer.
 Provide Certificate of Analysis of the relevant
batch of Drug Substance used during product
development and stability studies batch from
Drug Substance manufacturer.
3.2.P.2  Justify why Pharmaceutical equivalence and  Firm has again submitted Pharmaceutical
CDP of the applied product has not been Equivalence of applied product against the
performed against the innovator product? brand that is Empaa-M 5/500mg tablet by M/s
 Submit detailed CDP studies including details Weatherfolds Pharma by performing quality
of dissolution parameters, dissolution media, tests (Identification, Assay, Dissolution, weight
sampling time point and details of analytical variation).
parameters used and f2 factor calculation  Firm has submitted details of CDP studies
including details of dissolution parameters,
dissolution media, sampling time point and
details of analytical parameters. However CDP
has been performed against the comparator
product Empaa-M 5/500mg tablet by M/s
Weatherfolds Pharmaceuticals.
3.2.P.5  Justification is required for not including the  Firm has submitted revised finished product
test for assay in finished product specifications specifications containing content uniformity
 Detailed analytical procedures used for testing test, time point for dissolution studies and
the drug product shall be provided. details of assay test.
 Complete analytical method validation studies  Firm has submitted detailed analytical
including specificity test shall be submitted procedures used for testing the drug product
 Justification is required for not performing test shall be provided
for uniformity of dosage units (content  Firm has submitted analytical method
uniformity/weight variation) in batch analysis validation studies including results of
as recommended by innovator product review specificity test.
document  Firm has submitted copy of revised batch
 Submit readable copies of batch analysis report analysis report containing results of content
of three batches uniformity test
3.2.P.6 Clarification is required whether the same  Firm has not submitted any clarification.
Reference Standards or Materials of However, Firm has submitted COA of another
empagliflozin was used for test and analysis of working standard. The expiry date mentioned
drug product as the expiry date mentioned on the on this reference standard is 05-08-2020 and
COA of Reference Standards or Materials is manufacturing of trial batches is subsequent to
18.04.2018 while manufacturing date of drug this date.
product as per submitted COA is 08-2020
3.2.P.8  Submit complete analytical record of stability  Firm has submitted analytical record of
study including summary data sheets, COA, stability study including summary data sheets,
Raw data sheets, and chromatograms. COA. However detailed Raw data sheets and
Chromatograms of accelerated stability study chromatograms are not submitted
are attached with summary sheet of real time  Compliance Record of HPLC software 21CFR
study and vice versa & audit trail reports on product testing is
 Compliance Record of HPLC software 21CFR submitted
& audit trail reports on product testing is not  Record of Digital data logger for temperature
submitted and humidity monitoring of stability chambers
 Record of Digital data logger for temperature (real time and accelerated) is submitted
(real time and accelerated) is not submitted
 Valid GMP certificate / DML of drug substance manufacturer for Metformin issued by relevant
 Copies of the Drug substance analytical procedures used for routine testing of the Drug Substance
Metformin HCl by drug substance manufacturer.
Drug Substance Metformin HCl and Empagliflozin by Drug Product manufacturer.
 Clarification as the drug substance manufacturer has performed assay of drug substance Metformin
HCl in batch analysis by potentiometric method instead of HPLC method as per USP monograph.
 Justification for not performing test for identification (IR & Reaction of Chloride) and residue on
ignition for drug substance metformin HCl in batch analysis by drug product manufacturer as per USP
monograph
 Justification for not performing test for identification and residue on ignition for drug substance
Empagliflozin in batch analysis by drug product manufacturer as recommended by drug substance
manufacturer.
 Certificate of Analysis of the relevant batch of Drug Substance used during product development and
stability studies batch from Drug Substance manufacturer.
 Pharmaceutical equivalence and CDP of the applied product against the innovator product
 Clarification whether the same Reference Standards or Materials of empagliflozin was used for test
and analysis of drug product as the expiry date mentioned on the COA of Reference Standards or
Materials is 18.04.2018 while manufacturing date of trial batches is subsequent to this date.
 Detailed Raw data sheets and chromatograms are not submitted
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
726. 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
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 02 nd
manufacturer October 2020 based on inspection conducted on 27 th
September 2019
Name and address of API manufacturer. M/s Hubei Yitai Pharmaceutical Co. Ltd., Fengchengyuan,
Suburban District of Tianmen City, Hubei Province, China
specifications, batch analysis and stability studies of drug
substance
Batches:(02190501, 02190502, 02190503)
analytical procedure and its verification studies, batch
analysis and justification of specification, container closure
Pharmaceutical equivalence and Pharmaceutical Equivalence has been established against the
comparative dissolution profile brand that is Zovirax Topical Cream by M/s Barrett Hodgson
by performing quality tests (appearance, identification, fill
weight, drug release).
Analytical method validation/verification Not submitted
of product
Manufacturer of API M/s Hubei Yitai Pharmaceutical Co. Ltd., Fengchengyuan, Suburban District
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
4. Data of stability batches will be supported Firm have submitted Data of stability batches supported by
by attested respective documents like respective documents like UV spectra, raw data sheets and
chromatograms, Raw data sheets, COA, 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
1.6.5  Valid GMP certificate / DML of drug substance manufacturer 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
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.
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).
 Submit data of stability batches supported by attested respective documents like
chromatograms, Raw data sheets, COA, summary data sheets etc.
Response of the firm:
1.3.4  Submit valid copy of DML as the submitted Firm has submitted valid copy of DML renewed
DML is expired on 04-05-2021 and renewal w.e.f. 05-05-2021
of DML submitted on 17-05-2021
1.3.5  GMP inspection report/ GMP certificate of Firm has submitted cGMP certificate issued on 29th
the manufacturing unit issued within the September 2021 based on inspection conducted on
last three years shall be submitted 27th September 2021.
1.6.5  Valid GMP certificate / DML of drug Firm has submitted copy of cGMP certificate of
substance manufacturer issued by relevant M/s Hubei Yitai Pharmaceutical Co. Ltd.,
regulatory authority of country of origin is Fengchengyuan, Suburban District of Tianmen
required City, Hubei Province, China issued by Hubei
Provincial Food & Drug Administration valid up
to 17-09-2022.
2.3.R.1  Provide copy of Batch Manufacturing Not submitted
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  Copies of the analytical procedures used for
routine testing of the Drug substance by routine testing of the Drug substance by Drug
Drug substance and drug Product substance and drug Product manufacturer is
by the Drug Product manufacturer for drug manufacturer for drug substance is submitted.
3.2.S.4.4  Batch analysis of drug substance by drug  No clarification is submitted
substance manufacturer follow USP  Firm has submitted another COA of API by drug
specifications while Finished product product manufacturer in which date of analysis
manufacturer have tested the API as per BP has been changed to 29-10-2019
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 Details of container closure system and COA of
reference standard details are not submitted primary / secondary reference standard are
submitted
3.2.S.7  Long term stability data of drug substance Firm has submitted stability study data of other
is submitted for 12 months only batches of drug substance at real time and
accelerate conditions.
months
months
Batches:(02150501, 02150502, 02150503)
3.2.P.1  Justify the use of butylene paraben and  The firm has not submitted any justification for
methyl paraben in formulation as the use of butylene paraben and methyl paraben in
innovator product does not contain these formulation. However, the firm has changed the
excipients. composition of applied formulation which does
Applied product Innovator product not contain butylene paraben and methyl
(ZOVIRAX) paraben.
Stearic acid cetostearyl Applied product Innovator product
powder alcohol,. (ZOVIRAX)
Ethylene glycol mineral oil,
monostearate Cetostearyl alcohol, cetostearyl alcohol,.
Isopropyl poloxamer 407, Liquid Parafin, mineral oil,
myristate propylene glycol, propylene glycol,
Tween 80 propylene glycol, sodium lauryl sodium lauryl sulfate,
Butylene paraben sodium lauryl sulfate,
sulfate, white soft paraffin white petrolatum
Propylene glycol water poloxamer 407,
Methyl paraben white petrolatum Purified water q.s water
Sorbitol solution  No justification is submitted. However firm has
70% submitted Pharmaceutical Equivalence against
Lavender oil the brand that is Clovirex Cream by M/s Brookes
Purified water QS Pharmaceuticals by performing quality tests
 Pharmaceutical equivalence of applied (appearance, identification, fill weight, drug
product states that product follows the USP release, assay).
specification, while you have applied for  Process validation protocols for applied product
BP specifications for the applied product, is not submitted
justification is required
 Process validation protocols for applied
product shall be submitted
3.2.P.5  The limits of assay test as per monograph  Firm has submitted revised finished product
of BP pharmacopeia is 95-105% while you specifications in which limits of assay test are
have applied 45-55mg/g (90-110%) which revised as per BP monograph 47.5-52.5mg/g (95-
is different from BP, clarification is 105%)
required.  Firm has submitted revised analytical procedure
 Clarification is required since procedure of in which method of assay test is by HPLC as per
assay test given in analytical procedure is BP monograph (BP-2022). Firm has also
by UV while BP monograph for applied submitted UV spectrophotometric method for
products states performance by HPLC. assay test stating that it is as per BP 2003.
 Submit Analytical Method Verification  Analytical Method Verification studies including
studies including specificity, accuracy and specificity, accuracy and repeatability (method
repeatability (method precision) for drug precision) for drug product is performed as per
product as per BP method. UV method instead of HPLC.
 The copies of complete analysis of at least  Complete batch analysis of three batches are
two batches shall be provided while you submitted
have provided batch analysis of only one
batch, justify?
3.2.P.6  No details of reference standard is COA of primary / secondary reference standard is
submitted submitted
3.2.P.8  Clarification is required since assay test is  No clarification is submitted
performed by UV throughout stability study  Firm has submitted copy of invoice No.
instead by HPLC as recommended by BP. HYP191018-1 dated 18-10-2019 for import of
 Submit documents for the procurement of 25kg of Acyclovir USP (Batch# 02190314) in
API with approval from DRAP (in case of name of M/s Ophth Pharma (Pvt.) Ltd., attested
import). by AD (I&E) DRAP Karachi dated 24-10-2019
 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
stability chambers (real time and time and accelerated) is submitted
accelerated)  Firm has only submitted summary data sheet of
 Submit data of stability batches supported real time conditions. COA and UV spectra for
by attested respective documents like initial time point is also submitted. Summary
chromatograms, Raw data sheets, COA, data sheet for accelerated conditions is not
summary data sheets etc. submitted. Stability studies data supported by
chromatograms, Raw data sheets, COA are not
submitted
 Valid GMP certificate / DML of drug substance manufacturer issued by relevant regulatory authority
 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>
 Clarification for following BP monograph in Batch analysis of drug substance by drug product
manufacturer instead of USP monograph by drug substance manufacturer
 Clarification as 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
 Process validation protocols for applied product
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
precision) for drug product as per BP method.
 Submit the stability study by using pharmacopial method/specs.
 Stability summary data sheet for accelerated conditions is not submitted. Stability studies data
supported by attested respective documents like chromatograms, Raw data sheets, COA are not
submitted
Case No. 10: Deferred Registration applications of Human drugs on Form 5-F (Local)
727. Name, address of Applicant / Marketing M/s Genix Pharma (Pvt.) Ltd., 44-45B Korangi Creek
Authorization Holder Road Karachi
Name, address of Manufacturing site. M/s Genix Pharma (Pvt.) Ltd., 44-45B Korangi Creek
Road Karachi
☐ Importer
GMP status of the Finished product Not submitted
manufacturer
Evidence of approval of manufacturing Firm has submitted copy of letter No. F. 2-12/93-Lic
facility (Vol-V) dated 20-09-2021 which specifies Liquid
Injection (Ampoule, Vial, Infusion) (General) section
☐ Export sale
Details of fee submitted PKR 75,000/-: dated: 23-12-2021
(Deposit sip#8155830888)
The proposed proprietary name / brand name Genfer Injection 100mg/2ml
Strength / concentration of drug of Active Each 2ml ampoule contains:
Pharmaceutical ingredient (API) per unit Ferric hydroxide polymaltose complex equivalent to
Iron(III)……………100mg
Pharmaceutical form of applied drug Injection
Pharmacotherapeutic Group of (API) Use to treat Iron deficiency
Reference to Finished product specifications Innovator Specification
Proposed Pack size 5’s x2ml
The status in reference regulatory authorities Ferrosig Injection 100mg/2ml by M/s Sigma Company
Limited., TGA Approved
Name and address of API manufacturer. Biofer S.p.A. Legal headquarters and manufacturing
site: Via Canina, 2 - 41036 MEDOLLA (MO), Italy
Module III (Drug Substance) The firm has submitted detail of nomenclature,
form, manufacturers, specifications, analytical
justification of specification, container closure system
(Conditions & duration of Stability studies) Real time: 30 ± 2°C / 65 ± 5% RH) for 36 months
Accelerated: 40 ± 2°C / 75 ± 5% RH for 6 months
Batches: (FPJ 002 FP 01, FPJ 003 FP 01, FPJ 004 FP
01)
specification, container closure system and stability
dissolution profile against the brand that is Hemafer 100mg/2ml Injection
by M/s UNI-PHARMAKLEON LAORATORIES S.A
by performing quality tests (Identification, pH, Assay)
Analytical method validation/verification of Firm has submitted method validation studies including
product Specificity, Linearity, Accuracy, Precision-
Repeatability, Intermediate Precision, Robustness.
Manufacturer of API Biofer S.p.A. Legal headquarters and manufacturing site: Via Canina, 2 - 41036
MEDOLLA (MO), Italy
API Lot No. FPJ014FV20
Description of Pack
Amber glass Type I ampoule
Stability Storage Condition Real time: 30°C ± 2°C /65%± 5%RH
Accelerated: 40°C ± 2°C / 75%± 5%RH
Batch No. 21SB(A)-099-
21SB(A)-098-01 21SB(A)-100-03
02
Batch Size 500ampoules 500ampoules 500ampoules
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Firm has submitted Copy of GMP certificate in name of
manufacturer issued by concerned regulatory Biofer S.p.A. Legal headquarters and manufacturing
authority of country of origin. site: Via Canina, 2 - 41036 MEDOLLA (MO), Italy
issued by Italian Medicines Agency valid upto three
years from the date of inspection (date of inspection
28/06/2019)
4. Data of stability batches will be supported by Firm has submitted data of stability batches supported
attested respective documents like by attested respective documents like chromatograms,
chromatograms, Raw data sheets, COA, Raw data sheets, COA, summary data sheets etc.
6. Record of Digital data logger for temperature Record of Digital data logger for temperature and
and humidity monitoring of stability chambers humidity monitoring of stability chambers (real time
(real time and accelerated) and accelerated) for three months is submitted
XI
THERAPEUTIC INDICATIONS
FERROSIG is indicated for the treatment of iron deficiency anaemia in the following circumstances:
 When oral therapy is contraindicated.
 When enteric absorption of iron is defective.
 When patient non-compliance or persistent gastrointestinal intolerance makes oral therapy impractical.
1.3.5  GMP inspection report/ GMP certificate of the  Firm has submitted copy of cGMP
manufacturing unit issued within the last three certificate issued on 07-10-2021 based on
years shall be submitted inspection conducted on 15-06-2021.
1.5.5  Submit correct Pharmacological class of the  Parenteral iron preparations. Anti-anaemic
drug substance with proper reference
1.6.5  Valid GMP certificate / DML of drug The firm submitted clarification from AIFA
substance manufacturer issued by relevant Italy stating that due to restrictions caused by
regulatory authority of country of origin is covid-19, the period of validity of the GMP
required certificate is automatically extended until the
end of 2023. Onsite inspections will resume
as soon as there is a consensus that the period
of public health crisis has passed
3.2.S.4  Copies of the Drug substance analytical  Not submitted
procedures used for routine testing of the Drug
substance by Drug substance manufacturer is
required.
3.2.S.5  COA of primary / secondary reference According to Biofer MOA no working
standard including source and lot number shall standard are required for release analysis of
be provided. the API Ferric Hydroxide Polymaltose
Complex so, we cannot provide any CoA.
3.2.S.7  Results of Assay test for iron is not submitted Firm submitted revised real time stability
in stability study of drug substance, clarify study data of drug substance wherein Assay
test for iron and polymaltose has been
performed. However, time point of stability
study as per ICH guideline is not submitted.
Furthermore accelerated stability study data
is not submitted.
3.2.P.1  Justification is required for not using  In development of Genfer Injection
hydrochloric acid or sodium hydroxide for pH 100mg/2ml, the active substance (Ferric
adjustment in formulation Hydroxide Polymaltose Complex
Inj.Grade) is dissolved in water for
injection and mix until homogenization of
solution will be formed. Then Check the
pH of the solution.
pH limit = 5.2 – 6.50.
 The pH of the solution observed in the
range as described above therefore no need
to the addition of HCl or NaOH for pH
adjustment in the formulation.
 The product kept on stability and no
changes observed in pH of the formulation
and any other physical and chemical
parameters.
 Stability studies also demonstrated that the
formulation is stable without the addition
of pH adjusting agents.
3.2.P.2  Submit details of country of origin of  The firm submitted details of country of
reference product against which origin:
pharmaceutical equivalence studies have been UNI-PHARMA KLEON TSETIS
performed. Pharmaceutical Laboratory S.A 14Km
 Justification is required for not performing test National Road 1, GR-145 64K, Kifissia
for bacterial endotoxin and particulate matter GREECE
in pharmaceutical equivalence as submitted in  The firm has submitted revised
finished product specifications pharmaceutical equivalence report wherein
results of test for bacterial endotoxin and
particulate matter has been submitted
3.2.P.5.2  You have applied for innovator specifications The firm submitted that this is typographic
in module 1 section 1.5.6 while in-house error and submitted revise specification
specification in this section, justify? stating innovator specifications
3.2.P.6  COA of primary / secondary reference We have conducted assay of Iron by
standard including source and lot number shall complexometric titration, in this method
be provided. working standard is not required.
3.2.P.8  You have written liraglutide on initial page of  The firm submitted that this is typographic
summary sheet while applied product is ferric error and submitted corrected summary
hydroxide polymaltose complex, clarify? reports.
 Compliance Record of HPLC software 21CFR  Audit trial is not applicable as product
& audit trail reports on product testing is testing is carried out via titration method
required  Record of Digital data logger for
 Record of Digital data logger for temperature temperature and humidity monitoring of
and humidity monitoring of stability chambers stability chambers (real time and
(real time and accelerated) upto 6th months is accelerated) is submitted
required  Firm has submitted copy of invoice for
 Submit documents for the procurement of API import of 01Kg of Ferric Hydroxide
with approval from DRAP (in case of import). Polymaltose Complex (Batch No#
 Submit 6th month stability data of applied FPJ014FV20) in name of M/s Genix
product Pharma (Pvt.) Ltd., attested by AD (I&E)
DRAP Karachi dated 26-04-2021.
 6th month stability data of applied product
is submitted
Previous Decision (M-326-DRB): Deferred for submission of following:
 Copies of the Drug substance analytical procedures used for routine testing of the Drug substance by Drug
substance manufacturer is required.
 Stability study data of drug substance as per zone IV-A conditions till claimed shelf life.
 Pharmaceutical equivalence of applied product against innovator product
 Fee of Rs. 7,500/- for correction/pre-approval changes in specifications, as per notification No.F.7-11/2012-
Firm’s Response:
1  Copies of the Drug substance analytical  Copies of the Drug substance analytical
procedures used for routine testing of the procedures used for routine testing of the Drug
Drug substance by Drug substance substance by Drug substance manufacturer is
manufacturer is required. submitted
2  Stability study data of drug substance as Firm submitted revised stability study data of drug
per zone IV-A conditions till claimed shelf substance wherein Assay test for iron has been
life. performed.
Real time: 30 ± 2°C / 65 ± 5% RH) for 60 months
Accelerated: 40 ± 2°C / 75 ± 5% RH for 6 months
Batches: (FPJ 001 FV 17, FPJ 005 FV 16, FPJ 006
FV 15)
3  Pharmaceutical equivalence of applied  The firm has submitted pharmaceutical
product against innovator product equivalence against Ferrosig 100mg/2ml
injection by M/s Sigma Company Limited
Rowville, VIC, 3176 Australia by performing
quality test (Appearance, Identification, pH,
Assay, BET, Particulate matter)
 The firm has submitted revised pharmaceutical
equivalence report wherein results of test for
bacterial endotoxin and particulate matter has
been submitted
4  Fee of Rs. 7,500/- for correction/pre-  Firm has submitted fee Rs. 7,500/- for
approval changes in specifications, as per correction/pre-approval changes in
notification No.F.7-11/2012-B&A/DRAP specifications vide deposit slip#24404399145.
dated 13-07-2021.
Decision: Approved with innovator’s specifications.
application.
 Manufacturer will perform process validation of first three batches as per the commitment submitted in
728. Name, address of Applicant / M/s Bio-Labs (Pvt.) Ltd., Plot No. 145, Industrial Triangle,
Marketing Authorization Holder Kahuta road, Islamabad.
Name, address of Manufacturing site. M/s Bio-Labs (Pvt.) Ltd., Plot No. 145, Industrial Triangle,
Kahuta road, Islamabad.
☐ Importer
GMP status of the Finished product Firm has submitted GMP certificate issued on 21-05-2019
manufacturer based upon inspection conduct 23-4-2019, valid upto 22-4-
2022.
Evidence of approval of manufacturing Firm has submitted copy of letter No. F. 1-12/89-Lic (Vol-II)
facility dated 23-07-2012 which specifies Lyophilized Vials
(General) Section
☐ Export sale
Details of fee submitted PKR 30,000/-: dated 20-12-2021
(Deposit Slip#1799701158)
Voricol 200mg Injection
name
Strength / concentration of drug of Each vial contains:
Active Pharmaceutical ingredient (API) Voriconazole lyophilized powder……….200mg
per unit
Pharmaceutical form of applied drug Lyophilized powder
In-House specifications
specifications
The status in reference regulatory VFEND 200mg lyophilized powder for injection, USFDA
authorities approved
For generic drugs (me-too status) V.Zde 200mg/Vial Injection by M/s Neutro Pharma (Reg. No.
097657)
Name and address of API manufacturer. M/s Lee Pharma Limited., Survey No. 10/G-1,
Gaddapotharam (Village), Jinnaram (Mandal), Sangareddy
(District) Telangana State, 502319 India.
manufacturers, specifications, analytical procedures and its
The firm has summarized information of drug product
including its description, composition, pharmaceutical
excipients, control of drug product, specifications, analytical
procedures, validation/verification of analytical procedures,
batch analysis, justification of specifications, reference
standard or materials, container closure system and stability
study.
Module III (Drug Substance) Firm has submitted detailed data of drug substance related to
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 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 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.
(Batches: VR0411003, VR0411004, VR0411005)
specifications, analytical procedure and its validation studies,
drug product.
Pharmaceutical equivalence and Pharmaceutical Equivalence have been established against
comparative dissolution profile the brand that is Vfend injection by M/s Pfizer by performing
quality tests (Identification, pH, Assay).
Analytical method Firm has submitted method validation studies including
validation/verification of product linearity, range, accuracy, precision, specificity, robustness,
LOD, LOQ, system suitability.
Manufacturer of API M/s Lee Pharma Limited., Survey No. 10/G-1, Gaddapotharam (Village), Jinnaram
(Mandal), Sangareddy (District) Telangana State, 502319 India.
API Lot No. VZFP21019
Description of Pack
(Container closure 30ml transparent type I tubular Glass vial with rubber stopper and flip off seal
system)
Stability Storage Real time: 30°C ± 2°C / 65% ± 5%RH
Condition Accelerated: 40°C ± 2°C / 75% ± 5%RH
Time Period Real time: 0, 3 months
Accelerated: 0, 3 months
Frequency Accelerated: 0, 3 (Months)
Real Time: 0, 3 (Months)
Batch No. VOR 21-082 VOR 21-083 VOR 21-084
No. of Batches 03
1. Reference of previous approval of NA
the firm (if any)
2. Approval of API/ DML/GMP certificate Firm has submitted copy of GMP certificate in the name of
of API manufacturer issued by M/s Lee Pharma Limited., Survey No. 10/G-1,
concerned regulatory authority of Gaddapotharam (Village), Jinnaram (Mandal), Sangareddy
country of origin. (District) Telangana State, 502319 India issued by Drugs
Control Administration Government of Telangana valid upto
16-04-2022.
3. Documents for the procurement of API Firm has submitted copy of invoice No. 1108/LP/2021-22
with approval from DRAP (in case of dated 18-06-2021 for import of 1.5kg of Voriconazole EP
import). (Batch No# VZFP21019) in name of M/s Bio-Labs (Pvt.) Ltd.,
attested by AD (I&E) DRAP Islamabad dated 06-07-2021.
Firm has also submitted copy of form 6 dated 06-07-2021 for
import of 1.5kg of Voriconazole EP in name of M/s Bio-Labs
(Pvt.) Ltd., attested by AD (I&E) DRAP Islamabad dated 06-
07-2021.
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 data
documents like chromatograms, Raw sheets, COA, summary data sheets etc.
etc.
21CFR & audit trail reports on product reports on product testing upto 03 months is submitted
testing
6. Record of Digital data logger for Record of Digital data logger for temperature and humidity
temperature and humidity monitoring of monitoring of stability chambers (real time and accelerated)
stability chambers (real time and upto 03 months is submitted
accelerated)
1.3.5  GMP inspection report/ GMP certificate of the manufacturing unit issued within the last three
years shall be submitted
1.6.5  Valid GMP certificate of drug substance manufacturer issued by relevant regulatory authority
of country of origin is required
3.2.S.4  Clarification is required for use of placebo in specificity test of method verification studies
for drug substance
3.2.P.1.3  Reference shall be provided for recommending the use of 0.9% sodium chloride as diluent
for reconstitution
3.2.P.5  Justification is required for not including the test for water content, appearance and clarity of
reconstituted solution, colour of solution, reconstitution time, uniformity of dosage units,
osmolality, and particulate contamination in finished product specification as recommended
by EMA public assessment report.
 Justification is required for not including the test for filled weight in finished product
specifications
 Submit reference for selecting the limits of pH test in finished product specifications
3.2.P.6  The submitted COA of Reference Standards or Materials states that it is valid upto 01-08-
2021. Clarification is required whether the same Reference Standards or Materials was used
for test and analysis of drug product as the 3 rd month time point and 6th month time stability
study have been performed on October 2021 (10-2021) and January 2022 (01-2022).
3.2.P.8  Submit details of minimum handling capacities of the equipment used in manufacturing of
trial batches
 Submit stability study data of applied product at 6th month time point
 Compliance Record of HPLC software 21CFR & audit trail reports on product testing upto
06 months is not submitted
 Record of Digital data logger for temperature and humidity monitoring of stability chambers
(real time and accelerated) upto 06 months is not submitted
Previous Decision (M-326 –RB (14th -16th March 2023) (Publication date of Minutes; 108 th May 2023): Board
deferred the case for submission of reply to the above cited shortcomings within six months as the board was
apprised that the letter of shortcoming has been initially shared with the firm and waiting firm reply.
Firm’s Response (19th June 2023):
1.3.5  GMP inspection report/ GMP certificate  Firm has submitted copy of cGMP certificate
of the manufacturing unit issued within issued on 28th February 2022, based on
the last three years shall be submitted inspection conducted on 03-08-2021
1.6.5  Valid GMP certificate of drug substance  Firm has submitted copy of cGMP certificate
manufacturer issued by relevant in the name of M/s Lee Pharma Limited.,
regulatory authority of country of origin is Survey No. 10/G-1, Gaddapotharam (V),
required Jinnaram (M), Sangareddy (D) Telangana
State, 502319 India issued by Drugs Control
Administration Government of Telangana
valid upto 08-05-2023.
3.2.S.4  Clarification is required for use of placebo  The firm submitted that placebo details are
in specificity test of method verification mistakenly added in the AMV verification
studies for drug substance report and protocol of Raw material. The
revised report and protocol are submitted.
3.2.P.1.3  Reference shall be provided for  The firm submitted that as per EMC
recommending the use of 0.9% sodium assessment report dated, 26 March 2015
chloride as diluent for reconstitution “EMA/CHMP/151531/2015 Committee for
Medicinal Products for Human Use
(CHMP)” Voriconazole is physically
compatible and chemically stable when
reconstituted with water for injection or
Sodium chloride 0.9%.
3.2.P.5  Justification is required for not including  Firm has submitted revised SAP wherein test
the test for water content, appearance and for water content, appearance after
clarity of reconstituted solution, colour of reconstitution, reconstitution time,
solution, reconstitution time, uniformity uniformity of dosage units, are included in
of dosage units, osmolality, and finished product specification. However, test
particulate contamination in finished for osmolality, and particulate contamination
product specification as recommended by are still not included in specifications.
EMA public assessment report.  No justification is submitted
 Justification is required for not including  No reference provided
the test for filled weight in finished
product specifications
 Submit reference for selecting the limits
of pH test in finished product
specifications
3.2.P.6  The submitted COA of Reference  The firm submitted that we have used
Standards or Materials states that it is valid another working standard at 3rd month and 6th
upto 01-08-2021. Clarification is required month time. The COA of reference standard
whether the same Reference Standards or is submitted.
Materials was used for test and analysis of
drug product as the 3rd month time point
and 6th month time stability study have
been performed on October 2021 (10-
2021) and January 2022 (01-2022).
3.2.P.8  Submit details of minimum handling  Minimum handling capacity of equipment
capacities of the equipment used in used for trials bathes is 100 vials.
manufacturing of trial batches  Stability study data of applied product at 6th
 Submit stability study data of applied month time point is submitted
product at 6th month time point  Compliance Record of HPLC software
21CFR & audit trail reports on product testing upto 06 months is submitted
testing upto 06 months is not submitted  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 accelerated)
stability chambers (real time and upto 06 months is submitted
accelerated) upto 06 months is not
submitted
 Justification for not including the test for osmolality, filled weight and particulate contamination in
finished product specification
 Submit reference for selecting the limits of pH test in finished product specifications
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Case No. 11; Deferred Registration Application of Human Drugs on form 5F (cases of Dr. Akbar Ali):
Priority applications as per 257th meeting of RB
729. Name, address of Applicant / Importer M/s BF Biosciences Ltd 5-KM Sunder Raiwind Road,
Raiwind, District Lahore – Pakistan, Pakistan
Details of Drug Sale License of importer License No:05-352-0066-034461D
Address: 5-KM Sunder Raiwind Road, Raiwind, District
Lahore – Pakistan.
Address of Godown: NA
Validity: 29-06-2027.
Renewal: NA
Name and address of marketing Bioprofarma Bagó S.A. Terrada 1270 - Autonomous City
authorization holder (abroad) of Buenos Aires, Argentine Republic.
Name, address of manufacturer(s) Laboratorio Kemex S.A.
Nazarre 3446/54 - Autonomous City of Buenos Aires,
Argentine Republic.
Name of exporting country Argentine Republic
Detail of certificates attached (CoPP, CoPP: Firm has submitted original, legalized copy of CoPP
Freesale certificate, GMP certificate) certificate (No. IF-2022-09064835-APN-
DFYGR#ANMAT) dated 04-01-2022 issued by National
Institute of Drugs Avenida Caseros 2161 Ciudad Autonoma
de Buenos Aires-Republica Argentina for Fulvestrant
injection 250mg. 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.
Details of letter of authorization / sole Firm has submitted copy of letter of distribution certificate
agency agreement from Bioprofarma Bagó S.A. The letter species that the
manufacturer appoints M/s BF Biosciences Ltd. to register
their products in Pakistan. The authorization letter is valid
till 31-01-2023.
☒ Importer
☐ Export sale
only
Dy. No. and date of submission Dy.31009 dated No 01-11-2022
Details of fee submitted PKR 75,000/-:slip No. 04893286804 dated 25-04-2022
The proposed proprietary name / brand DIMERE injection 250mg
name
Strength / concentration of drug of Active Each 5 ml vial contains:
Pharmaceutical ingredient (API) per unit Fulvestrant ………………………….….250mg
Pharmaceutical form of applied drug Solution for Injection
Pharmacotherapeutic Group of (API) oestrogen receptor antagonists (L02BA03)
Reference to Finished product In house
specifications
Proposed unit price Rs 45,000 /- single dose vial
The status in reference regulatory FASLODEX 250mg Injection (AstraZeneca UK Limited).
authorities ( Pre Filled Syringe of 5 ml )
Name, address of drug substance Farmabios S.p.A.
manufacturer Via Pavia, 1 27027 Gropello Cairoli, (PV) – Italy
Module-III Drug Substance: Firm has submitted detailed drug substance data for both
sources related to nomenclature, structure, general
properties, solubility, physical form, manufacturers,
Stability Studies of Drug Substance Firm has submitted stability study data of 3 batches of API
(Conditions & duration of Stability at accelerated as well as real time conditions. The real time
studies) stability data is conducted at 5oC ± 3oC. The stability study
data is till 48 months.
process validation protocols, control of excipients, control
Pharmaceutical Equivalence and Submitted.
Comparative Dissolution Profile
Analytical method validation/verification Firm has submitted analytical method validation studies for
of product the applied product.
Container closure system of the drug USP type-I glass
product
Stability study data of drug product, shelf Firm has submitted stability study data of 3 batches The
life and storage conditions accelerated stability study data is conducted at 25 °C ± 2ºC/
60% ± 5% RH for 6 months. The real time stability study
data is conducted at 5 °C ± 3ºC. The real time stability study
data of 3 batches is for 24 months
Evaluation by PEC:
Sr. No Observations
01 DSL of Importer /applicant is expired till 29-06-2022.
02 Provided copy of GMP certificate of API/Drug substance manufacturer, I-e M/s Farmabiosa
S.P.A Italy, issued by AIFA, Italy vide certificate No. IT-API/167/H/2020 based on inspection
conducted on 20-09-2019 was valid for 30 months, which has been expired.
03 Justification of applied container closer system of finished drug product as glass vial whereas the
innovator product Faslodox is prefilled syringe.
04 Justification of overage of 0.4 ml excess filling in vial during filling process in line with innovator
product which is prefilled syringe.
Previous Decision (M-324DRB): Registration Board was apprised that the letter of shortcoming has been initially
six months.
Response of firm:
Sr# Observations Response of Firm
01 DSL of Importer /applicant is expired till 29- Firm has submitted valid copy of DSL. Details of DSL
06-2022. are;
License No:05-352-0066-034461D
Address: 5-KM Sunder Raiwind Road, Raiwind,
District Lahore – Pakistan.
Validity: 29-06-2027.
Renewal: NA
02 Provided copy of GMP certificate of Firm has submitted valid copy of GMP certificate of
API/Drug substance manufacturer, I-e M/s API/Drug substance manufacturer, i.e. M/s Farmabios
Farmabiosa S.P.A Italy, issued by AIFA, S.P.A Italy, issued by AIFA, Italy vide certificate No.
Italy vide certificate No. IT-API/167/H/2020 IT-API/167/H/2020 based on inspection conducted on
based on inspection conducted on 20-09- 2020-06-12 was valid for three years from date of
2019 was valid for 30 months, which has inspection.
been expired.
03 Justification of applied container closer Dimere 250mg solution for injection is a generic drug
system of finished drug product as glass vial product whose formulation, strength, pharmaceutical
whereas the innovator product Faslodox is form and dosage form are the same as innovator
prefilled syringe. product Falsodex 250mg (Lab. Astra Zeneca)
Dimere container closure system differs from Faslodex
finished product which is a pre-filled syringe. It
consists of vials appropriately closed with stoppers and
flip-off aluminium seals evidencing the same quality
on materials as pre-filled syringe. Stability studies
performed on Dimere dosage form confirms
compatibility and that the finished product keeps the
original attributes without alteration.
Selecting the right primary container presentation for a
product is important decision. Dimere is packed in
glass vials despite pre-filled syringes advantages due
to cost / benefit analysis and unavailability to access to
required technology facilities to use that container.
04 Justification of overage of 0.4 ml excess The firm submitted explanation as:
filling in vial during filling process in line 0.4ml (0.8%) in excess is added per vial during the
with innovator product which is prefilled filling process to ensure the deliverable volume and
syringe. administration of the labelled doses.
The final volume overage was empirically decided
during pilot batches evaluation and compliance is
confirmed batch to batch by analysis extractable
volume
Previous Decision (M-326-DRB): Deferred for evidence of approval of applied formulation in reference regulatory
authorities/agencies which were adopted by the Registration Board in its 275th meeting in glass vial
Firm’s Response:
The firm has submitted following response;
 Whereas, FULL V (Fulvestrant) 250mg Injection in Vial Form (M/s Laboratorios IMA S.A.I.C,
Argentina) is approved for another applicant/importer during 316th (15-18 March 2023) with decision i.e.
Approved as per Policy for inspection of Manufacturer abroad and verification of local storage facility.
(Copy of minutes attached). However, registration letter has not been issued.
 Additionally, Fulvestrant 250mg/5ml in Vial Form is also suggested to add in WHO Model List of
Essential Medicines, WHO Official link and document is attached for your kind reference.
 https://www.who.int/news/item/01-10-2021-who-prioritizes-access-to-diabetes-and-cancer-
treatments-in-new-essential-medicines-lists
 Application to add Fulvestrant to WHO Model List of Essential Medicines
In view of above facts and references, we kindly request to re-visit the decision and allow fair chance to BF
Biosciences Limited for registration of imported finished drug in Vial form, as BF Biosciences Limited is the joint
venture of Ferozsons Laboratories Limited and Bago Laboratories Argentina, and through this joint venture, a
number of lifesaving drugs are already registered by DRAP (eg. Panataxel, Donataxel and Oxaltie).
We also would like to apply for exemption of manufacturer abroad as ANMAT (Administración Nacional de
Medicamentos, Alimentos y Tecnología Médica) Argentina is the member of PIC/s.
Decision: Deferred for evidence of approval of applied formulation in reference regulatory
authorities/agencies, which were adopted by the Registration Board in its 275th meeting in glass vial.
Case No. 12: Deferred cases of form 5F (Export Facilitation):

730. Name, address of Applicant / Marketing M/s CCL Pharmaceuticals (Pvt.) Ltd., 62-Industrial Estate,
Authorization Holder Kot Lakhpat, Lahore.
Name, address of Manufacturing site. M/s CCL Pharmaceuticals (Pvt.) Ltd., 62-Industrial Estate,
Kot Lakhpat, Lahore.
☐ Importer
GMP status of the Finished product Firm has submitted cGMP certificate issued on 13-05-2019
Evidence of approval of manufacturing Firm has submitted copy of DML renewal letter No.F.1-8/84-
facility Lic(Vol-V) dated 08-06-2022 which specifies Tablet section
(General).
☐ Export sale
(Slip#4452496739)
The proposed proprietary name / brand Gablin CR 82.5mg Tablet
name
Strength / concentration of drug of Each Film Coated Tablet Contains:
Active Pharmaceutical ingredient (API) Pregabalin………….…82.5mg
per unit
Pharmaceutical form of applied drug Pink colored, oblong biconvex film coated tablet
Pharmacotherapeutic Group of (API) Anti-epileptics
specifications
The status in reference regulatory LYRICA CR extended-release tablets (82.5mg, 165mg, 330
authorities mg) by USFDA Approved.
Name and address of API manufacturer. M/s Kopran Research Laboratories Limited., K4/4,
Additional MIDC, Post Birwadi, Tal. Mahad, District:
Raigad, Raigad 402302, Maharashtra India.
drug substance
Batches: (PRG/P0904005, PRG/P0904006, PRG/P0904007)
analytical procedure, batch analysis and justification of
comparative dissolution profile the innovator Lyrica CR 82.5mg Tablet distributed by M/s
Parke-Davis Division of Pfizer Inc. NY, NY 10017, by
performing quality tests (Description, Identification, Assay,
Dissolution).
Lyrica CR 82.5mg Tablet distributed by M/s Parke-Davis
Division of Pfizer Inc. NY, NY 10017 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 Analytical method validation report is not submitted
validation/verification of product
Manufacturer of API M/s Kopran Research Laboratories Limited., K4/4, Additional MIDC, Post
Birwadi, Tal. Mahad, District: Raigad, Raigad 402302, Maharashtra India.
API Lot No. PRGH/P2012004D
Description of Pack Printed Alu-Alu blister packed in bleach board unit carton
Batch No. PGA T2-21 PGA T3-21 PGA T4-21
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate Firm has submitted License retention certificate dated 29-02-
of API manufacturer issued by concerned 2020 of M/s Kopran Research Laboratories Limited., India.,
regulatory authority of country of origin. issued by Food & Drugs Administration Maharashtra State
India valid upto 31-03-2025.
Firm has submitted cGMP certificate dated 20-10-2020 of
M/s Kopran Research Laboratories Limited., India., issued by
Commissioner, Food & Drugs Administration Maharashtra
State India valid upto 19-10-2023.
3. Documents for the procurement of API Firm has submitted copy of invoice No. EXP-393 dated 28-
with approval from DRAP (in case of 12-2020 for import of 100kg of Pregabalin (Batch#
import). PRGH/P2012004D) in name of M/s CCL Pharmaceuticals
(Pvt.) Ltd., attested by AD (I&E) DRAP Lahore dated 04-01-
2021
etc.
testing
accelerated)
1.3.5  GMP inspection report/ GMP certificate  Firm has submitted DML renewal Inspection
of the manufacturing unit issued within report conducted on 14.09.2020, 15.09.2020 and
the last three years shall be submitted 21.10.2020 and panel has recommended renewal
of DML for following sections;
Tablet (General), Capsule (General), Oral Liquid,
Dry Powder Suspension, Liquid Injectable &
Capsule section (Steroid).
 Firm has submitted Letter No. 8194/2022-DRAP
(Addl.Dire) dated 07.07.2022 from Additional
Director DRAP Lahore which states that; “The
Firm has applied for GMP Inspection. The
application is under process at DRAP Office and
inspection will be done as per availability of Area
FID. The firm’s last GMP status is Compliant /
Good.
1.5.2  Clarification is required as you have The firm submitted that applied formulation is as
applied for film coated tablets while the per reference formulation i.e., film coated extended
reference formulation is film coated release that is evident from dissolution results.
extended release tablets or revise your Label claim for products is:
label claim as per reference formulation Each film coated extended-release tablet
along with submission of applicable fee. contain:
Pregabalin……………….82.5mg.
3.2.S.4  Justification is required for claiming in-  The firm submitted that Pregabalin Monograph
house specifications for drug substance has become official as of 01-Nov-2020, and the
by drug substance manufacturer and drug substance lot being used in developmental
product manufacturer as the monograph studies, manufactured in Dec 2020, that’s why
for applied drug substance is available in API manufacturer used in house specs.
pharmacopeia (BP, USP) Moreover, Pregabalin is already inducted
 Justification is required for using in- material for CCL. Both Drug substance
house analytical method for drug manufacturer and drug product manufacturer are
substance by drug substance in process of shifting the specification as per USP
manufacturer and drug product Monograph.
manufacturer as the analytical method  The firm submitted that Pregabalin Monograph
for applied drug substance is available in has become official as of 01-Nov-2020, and the
pharmacopeia (BP, USP) substance lot being used in developmental
studies, manufactured in Dec 2020, that’s why
 Clarification is required whether the API manufacturer used in house analytical
same Reference Standards or Materials method. Moreover, Pregabalin is already
was used for test and analysis of drug inducted material for CCL. Both Drug substance
substance as the COA of Reference manufacturer and Drug product manufacturer are
Standards or Materials states that it is to in process of shifting the analytical method as per
be used before 19-03-2016, while USP Monograph.
manufacturing date of drug substance as  The firm submitted that provided COA of
per submitted COA is Dec 2020. reference standard was taken from DMF. COA of
working standard used for the analysis of drug
substance is submitted which states that it is to be
used before 11-07-2021.
3.2.P.2  Submit evidence for storing samples The firm submitted record of data logger for
prepared for compatibility study at 60°C temperature and humidity monitoring for sample
± 3°C / 75% ± 5%RH for 10 days prepared for compatibility study
3.2.P.5  Justification is required for changing  The firm submitted that in product test method
wavelength during assay procedure in 300nm is used to suppress blank peak and the
analytical method from 300nm to 210nm principal peak of pregabalin is around 5.1 that’s
after 4.5 minutes why wavelength is changed at 210nm from
 Submit analytical method validation 4.5min to onward.
report for the applied product  Firm has submitted analytical method validation
studies including specificity, linearity and range,
accuracy, precision, LOD & LOQ, robustness
and solution stability and system suitability
studies.
3.2.P.6  Clarification is required whether the  The firm submitted that same reference standard
same Reference Standards or Materials was used for analysis of drug product as the
was used for test and analysis of drug sequence / chromatograms against this standard
product as the COA of Reference was saved during trial analysis and same
Standards or Materials states that it is to sequence / chromatograms of standard was used
be used before 11-07-2021, while at 3rd and 6th Month stability study time point for
manufacturing date of drug product as analysis of drug product. It is to submit that the
per submitted COA is April 2021 and 3rd Reference Standards or Materials used for test
month time point and 6th month time and analysis of drug product was expired at 6 th
stability study are due on July 2021 (07- month time point (October 2021 (10-2021)) of
2021) and October 2021 (10-2021). stability study.
3.2.P.8  The wavelength mentioned in analytical  The firm submitted that in product test method
procedure is 210nm for assay test while wavelength started from 300nm and then
submitted chromatograms of stability changed to 210nm after 4.5min. So in
study show 300nm, justification is chromatogram starting wavelength is mentioned
required which is 300nm.
 Clarification is required for not  Firm has submitted results and calculation details
including the results and calculation for content uniformity test in raw data sheet at
details for content uniformity test in raw initial time point of stability study.
data sheet at initial time point of stability  Raw data sheet for assay test with real time
study values for average area of sample, average area
 Raw data sheet for assay test with real of standard, conc. of standard, conc. of sample,
time values for average area of sample, average weight, label claim and standard potency
average area of standard, conc. of in calculation formula is submitted.
standard, conc. of sample, average  Record of Digital data logger for temperature
weight, label claim and standard potency and humidity monitoring of stability chambers
in calculation formula shall be submitted (real time and accelerated) is submitted.
 Submit Record of Digital data logger for
accelerated)
Previous Decision (324-DRB): Deferred for scientific justification of following points:
 Use of sequence / chromatograms of standard saved during initial time point analysis for the drug product
analysis of 3rd and 6th Month stability study time point.
 Use of dual wavelengths for the analysis of single drug substance containing formulation.
 The wavelength mentioned in analytical procedure is 210nm for assay test while submitted chromatograms of
stability study show 300nm, justification is required
Response of firm:
Sr# Observations Response
01 Use of sequence / chromatograms of The firm submitted that we have also used the reference
standard saved during initial time point standard submitted as Annex-1 for the analysis of Drug
analysis for the drug product analysis of 3rd product at 6th Month Stability study time point.
and 6th Month stability study time point. Moreover, as we were in phase of shifting the Specs of
Raw Material from In-house to USP so we have also
used the Reference standard involved in Specification
shifting attached as Annex-1. We are submitting the
following Supporting documents.
1) Raw Material Test Method
2) COA of Raw Material
3) Verification of Analytical Method
4) COA of Reference Standard used in shifting the
specification.
02 Use of dual wavelengths for the analysis of The firm submitted that in dissolution chromatograms
single drug substance containing you can see at 210nm is the main peak of pregabalin,
formulation. 300nm wavelength is not interfaring with pregabalin
response, specificity chromatogram is submitted in
AMV report. Method trail is also attached.
03 The wavelength mentioned in analytical The firm submitted that as already communicated that
procedure is 210nm for assay test while in product test method wavelength started from 300nm
submitted chromatograms of stability study and then changed to 210nm after 4.5min. Method trail
show 300nm, justification is required is also submitted. In Chromatograms starting
wavelength is mentioned which is 300nm.
Previous Decision (M-326-DRB): Deferred for scientific justification of following points:
Response of firm:
01 Use of sequence / chromatograms of The firm submitted that Testing for the 3rd and 6th
standard saved during initial time point month was conducted using a valid (Validity date
analysis for the drug product analysis of 3rd 07/07/2023) working standard provided by the Drug
and 6th Month stability study time point. substance manufacturer. (WKS no. WS/PRG IP
IH/21/01).
As indicated in our initial dossier, the 3rd month testing
was carried out on August 20, 2021, while the 6th month
testing was conducted on November 18, 2021.
Additionally, our company regularly produces and
supplies Gablin capsules.
We also procure the reference standard on a regular
basis. COA of Valid working standard is submitted.
Email correspondence for procurement of Working
standard is also submitted.
02 Use of dual wavelengths for the analysis of The dual wavelength is employed to suppress the peak
single drug substance containing of the diluent sodium disulfide, as shown in the
formulation. attached chromatogram.
The peak height of sodium disulfide is significantly
larger compared to Pregabalin when the sample is run
at 210nm. Consequently, the peak or area of Pregabalin
will not be visible in the chromatogram.
With a retention time of approximately 5.5 minutes, the
quantification of Pregabalin remains unaffected by the
wavelength shift. This fact is confirmed in the AMV
(Assay Method Validation) report of the drug product.
Furthermore, we conducted a pharmaceutical
equivalence assessment of our product against the
innovator, and we observed a similar behavior of the
diluent in the innovator product as well. Comparative
chromatograms submitted
03 The wavelength mentioned in analytical The firm submitted that the initial wavelength indicated
procedure is 210nm for assay test while on the chromatogram is 300nm, as there is no provision
submitted chromatograms of stability study on the chromatogram format for both wavelengths.
show 300nm, justification is required However, we have included the method audit trail
which clearly shows that there was a wavelength shift
from 300 nm to 210nm.
(Acquisition method report is submitted).
Decision: Approved with innovator’s specifications and following label claim:
Each film coated extended-release tablet contain:
Pregabalin……………….82.5mg.
application.
Registration letter will be issued after submission of fee of Rs. 75,000/- for correction/pre-approval change
in composition (correction/change of formulation from film-coated tablet to film coated extended release
tablet), as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
☐ Importer
(General).
☐ Export sale
(Slip#20328944978)
The proposed proprietary name / brand Gablin CR 165mg Tablet
name
Active Pharmaceutical ingredient (API) Pregabalin………….…165mg
per unit
Pharmaceutical form of applied drug Light brown colored, oblong biconvex film coated tablet
specifications
drug substance
comparative dissolution profile the innovator Lyrica CR 165mg Tablet distributed by M/s
Dissolution).
Lyrica CR 165mg Tablet distributed by M/s Parke-Davis
Batch No. PGB T2-21 PGB T3-21 PGB T4-21
No. of Batches 03
the firm (if any)
2021
etc.
testing
accelerated)
1.3.5  GMP inspection report/ GMP certificate  Firm has submitted DML renewal Inspection
of the manufacturing unit issued within report conducted on 14.09.2020, 15.09.2020 and
the last three years shall be submitted 21.10.2020 and panel has recommended renewal
of DML for following sections;
Tablet (General), Capsule (General), Oral Liquid,
Dry Powder Suspension, Liquid Injectable &
Capsule section (Steroid).
Director DRAP Lahore which states that; “The
Firm has applied for GMP Inspection. The
application is under process at DRAP Office and
inspection will be done as per availability of Area
FID. The firm’s last GMP status is Compliant /
Good.
1.5.2  Clarification is required as you have The firm submitted that applied formulation is as
applied for film coated tablets while the per reference formulation i.e., film coated extended
reference formulation is film coated release that is evident from dissolution results.
extended release tablets or revise your Label claim for product is:
label claim as per reference formulation Each film coated extended-release tablet
along with submission of applicable fee. contain:
Pregabalin……………….165mg.
3.2.S.4  Justification is required for claiming in-  The firm submitted that Pregabalin Monograph
house specifications for drug substance has become official as of 01-Nov-2020, and the
by drug substance manufacturer and drug substance lot being used in developmental studies,
product manufacturer as the monograph manufactured in Dec 2020, that’s why API
for applied drug substance is available in manufacturer used in house specs. Moreover,
pharmacopeia (BP, USP) Pregabalin is already inducted material for CCL.
 Justification is required for using in- Both Drug substance manufacturer and drug
house analytical method for drug product manufacturer are in process of shifting the
substance by drug substance specification as per USP Monograph.
manufacturer and drug product  The firm submitted Pregabalin Monograph has
manufacturer as the analytical method become official as of 01-Nov-2020, and the
for applied drug substance is available in substance lot being used in developmental studies,
pharmacopeia (BP, USP) manufactured in Dec 2020, that’s why API
 Clarification is required whether the manufacturer used in house analytical method.
same Reference Standards or Materials Moreover, Pregabalin is already inducted material
was used for test and analysis of drug for CCL. Both Drug substance manufacturer and
substance as the COA of Reference Drug product manufacturer are in process of
Standards or Materials states that it is to shifting the analytical method as per USP
be used before 19-03-2016, while Monograph.
manufacturing date of drug substance as  The firm submitted that provided COA of
per submitted COA is Dec 2020. reference standard was taken from DMF. COA of
working standard used for the analysis of drug
substance is submitted which states that it is to be
used before 11-07-2021.
prepared for compatibility study at 60°C temperature and humidity monitoring for sample
± 3°C / 75% ± 5%RH for 10 days prepared for compatibility study
analytical method from 300nm to 210nm principal peak of pregabalin is around 5.1 that’s
after 4.5 minutes why wavelength is changed at 210nm from 4.5min
 Submit analytical method validation to onward.
accuracy, precision, LOD & LOQ, robustness and
solution stability and system suitability studies.
3.2.P.6  Clarification is required whether the  The firm submitted that same reference standard
same Reference Standards or Materials was used for analysis of drug product as the
was used for test and analysis of drug sequence / chromatograms against this standard
product as the COA of Reference was saved during trial analysis and same sequence
Standards or Materials states that it is to / chromatograms of standard was used at 3rd and
be used before 11-07-2021, while 6th Month stability study time point for analysis of
manufacturing date of drug product as drug product. It is to submit that the Reference
per submitted COA is April 2021 and 3rd Standards or Materials used for test and analysis
month time point and 6th month time of drug product was expired at 6th month time
stability study are due on July 2021 (07- point (October 2021 (10-2021)) of stability study.
2021) and October 2021 (10-2021).
3.2.P.8  The wavelength mentioned in analytical  The firm submitted that in product test method
procedure is 210nm for assay test while wavelength started from 300nm and then changed
submitted chromatograms of stability
study show 300nm, justification is to 210nm after 4.5min. So in chromatogram
required starting wavelength is mentioned which is 300nm.
 Clarification is required for not  Firm has submitted results and calculation details
including the results and calculation for content uniformity test in raw data sheet at
details for content uniformity test in raw initial time point of stability study.
data sheet at initial time point of stability  Raw data sheet for assay test with real time values
study for average area of sample, average area of
 Raw data sheet for assay test with real standard, conc. of standard, conc. of sample,
time values for average area of sample, average weight, label claim and standard potency
average area of standard, conc. of in calculation formula is submitted.
standard, conc. of sample, average  Record of Digital data logger for temperature and
weight, label claim and standard potency humidity monitoring of stability chambers (real
in calculation formula shall be submitted time and accelerated) is submitted.
 Submit Record of Digital data logger for
accelerated)
Response of firm:
01 Use of sequence / chromatograms of standard The firm submitted that we have also used the
saved during initial time point analysis for the reference standard submitted as Annex-1 for the
drug product analysis of 3rd and 6th Month analysis of Drug product at 6th Month Stability study
stability study time point. time point.
Moreover, as we were in phase of shifting the Specs
of Raw Material from In-house to USP so we have
also used the Reference standard involved in
Specification shifting attached as Annex-1. We are
submitting the following Supporting documents.
specification.
02 Use of dual wavelengths for the analysis of The firm submitted that in dissolution
single drug substance containing formulation. chromatograms you can see at 210nm is the main
peak of pregabalin, 300nm wavelength is not
interfaring with pregabalin response, specificity
chromatogram is submitted in AMV report. Method
trail is also attached.
03 The wavelength mentioned in analytical The firm submitted that as already communicated
procedure is 210nm for assay test while that in product test method wavelength started from
submitted chromatograms of stability study 300nm and then changed to 210nm after 4.5min.
show 300nm, justification is required Method trail is also submitted. In Chromatograms
starting wavelength is mentioned which is 300nm.
Response of firm:
IH/21/01).
application.
☐ Importer
(General).
☐ Export sale
(Slip#683187860)
The proposed proprietary name / brand Gablin CR 330mg Tablet
name
Active Pharmaceutical ingredient (API) Pregabalin………….…330mg
per unit
Pharmaceutical form of applied drug Orange colored, oblong biconvex film coated tablet
specifications
drug substance
comparative dissolution profile the innovator Lyrica CR 330mg Tablet distributed by M/s
Dissolution).
Lyrica CR 330mg Tablet distributed by M/s Parke-Davis
Batch No. PGC T2-21 PGC T3-21 PGC T4-21
No. of Batches 03
the firm (if any)
2021
etc.
testing
accelerated)
1.3.5  GMP inspection report/ GMP  Firm has submitted DML renewal Inspection report
certificate of the manufacturing unit conducted on 14.09.2020, 15.09.2020 and
issued within the last three years shall 21.10.2020 and panel has recommended renewal of
be submitted DML for following sections;
Tablet (General), Capsule (General), Oral Liquid, Dry
Powder Suspension, Liquid Injectable & Capsule
section (Steroid).
Director DRAP Lahore which states that; “The Firm
has applied for GMP Inspection. The application is
under process at DRAP Office and inspection will be
done as per availability of Area FID. The firm’s last
GMP status is Compliant / Good.
1.5.2  Clarification is required as you have The firm submitted that applied formulation is as per
applied for film coated tablets while reference formulation i.e., film coated extended release
the reference formulation is film that is evident from dissolution results.
coated extended release tablets or Label claim for products is:
revise your label claim as per Each film coated extended-release tablet
reference formulation along with contain:
submission of applicable fee. Pregabalin……………….330mg.
3.2.S.4  Justification is required for claiming  The firm submitted that Pregabalin Monograph has
in-house specifications for drug become official as of 01-Nov-2020, and the substance
substance by drug substance lot being used in developmental studies,
manufacturer and drug product manufactured in Dec 2020, that’s why API
manufacturer as the monograph for manufacturer used in house specs. Moreover,
applied drug substance is available in Pregabalin is already inducted material for CCL.
pharmacopeia (BP, USP) Both Drug substance manufacturer and drug product
 Justification is required for using in- manufacturer are in process of shifting the
house analytical method for drug specification as per USP Monograph.
substance by drug substance  The firm submitted that Pregabalin Monograph has
manufacturer and drug product become official as of 01-Nov-2020, and the substance
manufacturer as the analytical method lot being used in developmental studies,
for applied drug substance is available manufactured in Dec 2020, that’s why API
in pharmacopeia (BP, USP) manufacturer used in house analytical method.
 Clarification is required whether the Moreover, Pregabalin is already inducted material for
same Reference Standards or CCL. Both Drug substance manufacturer and Drug
Materials was used for test and product manufacturer are in process of shifting the
analysis of drug substance as the analytical method as per USP Monograph.
COA of Reference Standards or  The firm submitted that provided COA of reference
Materials states that it is to be used standard was taken from DMF. COA of working
before 19-03-2016, while standard used for the analysis of drug substance is
manufacturing date of drug substance submitted which states that it is to be used before 11-
as per submitted COA is Dec 2020. 07-2021.
prepared for compatibility study at temperature and humidity monitoring for sample
60°C ± 3°C / 75% ± 5%RH for 10 days prepared for compatibility study
analytical method from 300nm to principal peak of pregabalin is around 5.1 that’s why
210nm after 4.5 minutes wavelength is changed at 210nm from 4.5min to
 Submit analytical method validation onward.
accuracy, precision, LOD & LOQ, robustness and
solution stability and system suitability studies.
3.2.P.6  Clarification is required whether the  The firm submitted that same reference standard was
same Reference Standards or used for analysis of drug product as the sequence /
Materials was used for test and chromatograms against this standard was saved
analysis of drug product as the COA during trial analysis and same sequence /
of Reference Standards or Materials chromatograms of standard was used at 3rd and 6th
states that it is to be used before 11- Month stability study time point for analysis of drug
07-2021, while manufacturing date of product. It is to submit that the Reference Standards
drug product as per submitted COA is or Materials used for test and analysis of drug product
April 2021 and 3rd month time point was expired at 6th month time point (October 2021
and 6th month time stability study are (10-2021)) of stability study.
due on July 2021 (07-2021) and
October 2021 (10-2021).
3.2.P.8  The wavelength mentioned in  The firm submitted that in product test method
analytical procedure is 210nm for wavelength started from 300nm and then changed to
assay test while submitted 210nm after 4.5min. So in chromatogram starting
chromatograms of stability study wavelength is mentioned which is 300nm.
show 300nm, justification is required  Content uniformity for Gablin CR Tablet 330mg is
 Clarification is required for not performed by weight variation as per <USP 905>.
including the results and calculation  Raw data sheet for assay test with real time values for
details for content uniformity test in average area of sample, average area of standard,
raw data sheet at initial time point of conc. of standard, conc. of sample, average weight,
stability study label claim and standard potency in calculation
 Raw data sheet for assay test with real formula is submitted.
time values for average area of  Record of Digital data logger for temperature and
sample, average area of standard, humidity monitoring of stability chambers (real time
conc. of standard, conc. of sample, and accelerated) is submitted.
average weight, label claim and
standard potency in calculation
formula shall be submitted
 Submit Record of Digital data logger
for temperature and humidity
monitoring of stability chambers (real
Response of firm:
01 Use of sequence / chromatograms of The firm submitted that we have also used the reference
standard saved during initial time point standard submitted as Annex-1 for the analysis of Drug
analysis for the drug product analysis of 3rd product at 6th Month Stability study time point.
and 6th Month stability study time point. Moreover, as we were in phase of shifting the Specs of
Raw Material from In-house to USP so we have also
used the Reference standard involved in Specification
shifting attached as Annex-1. We are submitting the
following Supporting documents.
specification.
02 Use of dual wavelengths for the analysis of The firm submitted that in dissolution chromatograms
single drug substance containing you can see at 210nm is the main peak of pregabalin,
formulation. 300nm wavelength is not interfaring with pregabalin
response, specificity chromatogram is submitted in
AMV report. Method trail is also attached.
03 The wavelength mentioned in analytical The firm submitted that as already communicated that
procedure is 210nm for assay test while in product test method wavelength started from 300nm
submitted chromatograms of stability study and then changed to 210nm after 4.5min. Method trail
show 300nm, justification is required is also submitted. In Chromatograms starting
wavelength is mentioned which is 300nm.
Response of firm:
IH/21/01).
application.
Case No.13; Deferred cases of Human Drugs on Form 5

733. Name and address of manufacture / M/s Efroze Chemical Industries Pvt Ltd.
Applicant 146/23, Korangi Industrial Area, Karachi
Brand Name + Dosage Form and Dufanor 10mg Tablet
Strength
Composition Each Film Coated Tablet Contains:
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
Finished product specifications USP
Pack size and Demand Price 20’s; As per SRO
Approval status of product in Reference Duphaston 10mg film-coated tablets by M/s Mylan IRE
Regulatory Authorities Healthcare Limited (Ireland Approved)
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
Previous Decision (322-DRB)  Deferred for confirmation of already registered products in
section of “Tablet (Hormone) section.)
Firm’s Response  Firm has submitted copy of registration letter dated 30th May,
2023, of Eforeth-N 5mg tablets (Norethisterone)
(Reg#115972)
Decision: Approved as per decision of 312th meeting of Registration Board regarding formulation
of “Dydrogesterone Tablet”.
Case No. 14: Withdrawal of Form 5-D Applications for Registration of Daplozmet XR 5mg/500mg
Tablets, Daplozmet XR 5mg/1000mg Tablets, Daplozmet XR 10mg/500mg Tablets and Daplozmet XR
10mg/1000mg Tablets
The firm has written letter with reference to their product applied on Form 5-D details of which are given
below:
S No. Company Name Applied product Diary Number & Date of
R&I Date Submission
734. M/s Highnoon Daplozmet XR 5mg/500mg Tablets Form-5D 12-07-2016
Laboratories Ltd Each tablets contains: Dy.No.2789 R&I
Lahore Dapagliflozin…………..5mg date 12-07-2016
Metformin HCL (Extended
release)…………500mg
Lahore Dapagliflozin…………..10mg date 12-07-2016
Metformin HCL (Extended release)
……500mg
Lahore Dapagliflozin………..5mg date 12-07-2016
Metformin HCL (Extended release)
……1000mg
Lahore Dapagliflozin………..10mg date 12-07-2016
Metformin HCL (Extended
release)……1000mg
The firm informed that dossier of the same products were also applied on CTD/Form 5F and latterly got evaluated
for registration by DRAP on export facilitation priority. The firm further stated that we are applying for the
withdrawal of our applications of form 5-D as products are already under registration process through CTD/Form
5-D
Decision: Registration Board acceded the request of the firm and declared the above applications of
Daplozmet XR Tablets of M/s Highnoon Laboratories Ltd as disposed off.
M/s Carer Pharmaceuticals Industries, Plot # 27, Main Road, Rawat Industrial Estate, Rawat.
approved the grant of Drug Manufacturing License by way of formulation with following five sections to
M/s, Carer Pharmaceuticals Industries Plot # 27, Main Road, Rawat Industrial Estate, Rawat under Drug
07th June 2021. The Drug Manufacturing License No. 000925 by way of formulation is hereby issued w.e.f.
18-03-2021.
S No. Section
7. Capsule Section (General) Section
8. Dry Powder Suspension (General) Section
9. Sachet (General) Section
10. Ampoule (General) Section
11. Tablet (General) Section
☐ Importer
GMP status of the Finished product New license granted on 07/06/2021 and
manufacturer
Evidence of approval of manufacturing facility New license granted vide letter No. F. 1-32/2016-Lic dated
07/06/2021.
powder suspension (general) and ampoule (general)
sections are approved.
☐ Export sale
The proposed proprietary name / brand name Caraflox 250mg Tablet
Pharmaceutical ingredient (API) per unit Levofloxacin (as Hemihydrate)………..250mg
The status in reference regulatory authorities LEVAQUIN 250mg film coated tablets, USFDA
approved
Discontinued**Federal Register determination that
product was not discontinued or withdrawn for safety or
effectiveness reasons**
Levofloxacin 250mg film-coated tablets MHRA
Approved
For generic drugs (me-too status) Leflox 250mg Tablet by M/s Getz Pharma (Reg#26164)
Name and address of API manufacturer. M/s Zhejiang East-Asia Pharmaceutical Co., Ltd.,
Economic Development Zone of Sanmen County,
Zhejiang 31700, P.R. China
Batches: (DC-0401-1203001, DC-0401-1203002, DC-
0401-1203003)
specifications, analytical procedure, batch analysis and
Pharmaceutical equivalence and comparative Firm has submitted results of pharmaceutical equivalence
dissolution profile for their product against product Leflox 250mg tablet by
M/s Getz Pharma by performing quality tests
(Identification, uniformity of dosage units, disintegration
test, dissolution, assay)
CDP has been performed against the product Leflox
250mg tablet by M/s Getz Pharma in acidic media (pH
1.2), Acetate buffer (pH 4.5) & Phosphate Buffer (pH 6.8).
The values for f2 are in the acceptable range.
product Accuracy, precision (repeatability).
Manufacturer of API M/s Zhejiang East-Asia Pharmaceutical Co., Ltd., Economic Development Zone
of Sanmen County, Zhejiang 31700, P.R. China
API Lot No. DC-004-2112011
Description of Pack Alu-Alu Blister packed in unit carton
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API The firm has submitted copy of cGMP certificate of M/s
manufacturer issued by concerned regulatory Zhejiang East-Asia Pharmaceutical Co., Ltd., Coastal
authority of country of origin. Industrial city, Pubagang town, Sanmen County, Zhejiang
China issued by China Food & Drug Administration valid
upto 15-08-2021.
3. Documents for the procurement of API with Firm has submitted copy of clearance certificate for import
approval from DRAP (in case of import). of 05kg Levofloxacin Hemihydrate from M/s Zhejiang
East Asia Pharmaceutical Company., Ltd China attested by
AD (I&E) DRAP Islamabad dated 11-05-2022.
attested respective documents likeattested respective documents like chromatograms, Raw
6. Record of Digital data logger for temperature Record of Digital data logger for temperature and humidity
and humidity monitoring of stability chambers monitoring of stability chambers (real time and
(real time and accelerated) accelerated) is submitted
XI
1.6.5  Valid GMP certificate / DML of the Drug Substance manufacturer issued by relevant 
 Address mentioned on submitted GMP certificate is different than that given in
section 1.6.5
2.3.R.1  Provide copy of Batch Manufacturing Record (BMR) for all the batches of drug 
3.2.S.4  Signed copies of drug substance specifications shall be submitted 
 Result for specificity test are not submitted in method verification study
 Test for specific rotation is not performed in batch analysis by drug product
manufacturer as recommended by USP monograph
3.2.P.2  Justification shall be submitted for not performing pharmaceutical equivalence and 
CDP studies against the innovator product
 Submit the image/picture/snapshot of innovator /reference/comparator pack against
which Pharmaceutical equivalence/Comparative dissolution profile studies have been
performed and shall reveal the details of brand name, manufacturer, batch# and expiry
date of the innovator /reference/comparator product
3.2.P.5  Justification is required for not mentioning the number of USP test used for 
dissolution study
 The rpm used in dissolution study (50rpm) is different than that recommended by USP
monograph (75rpm)
 Result for specificity test are not submitted in method verification study
3.2.P.8  The submitted UV spectra does not depict the batch number or dosage form of applied 
formulation
☐ Importer
GMP status of the Finished product New license granted on 07/06/2021.
manufacturer
Evidence of approval of manufacturing facility New license granted vide letter No. F. 1-32/2016-Lic dated
07/06/2021.
powder suspension (general) and ampoule (general)
sections are approved.
☐ Export sale
Dy. No. and date of submission Dy. No. 9674; dated 11/04/2023
The proposed proprietary name / brand name Krasil Injection 250mg/2ml
Strength / concentration of drug of Active 250mg/2ml ampoule
Pharmaceutical ingredient (API) per unit
Pharmacotherapeutic Group of (API) Aminoglycoside Antibiotics
Proposed Pack size 5s & 1s
The status in reference regulatory authorities Could not be confirmed
For generic drugs (me-too status) Cimikan 250mg/2ml Injection by M/s Trigon
Pharmaceuticals (Reg#46021)
Name and address of API manufacturer. M/s Shandong Anxin Pharmaceutical Co. Ltd., No. 849,
Dongjia Town, Licheng District, Jinan, China
Module III (Drug Substance) The firm has submitted details of nomenclature, structure,
manufacturers, specifications, analytical procedures and
Batches: (120835205A, 120835505A, 120835805A)
specifications, analytical procedure, batch analysis and
Pharmaceutical equivalence and comparative Firm has submitted results of pharmaceutical equivalence
dissolution profile for their product against Grasil 250mg Injection by M/s
Sami Pharmaceuticals by performing quality tests
(Description, acidity, particulate matter, assay, sterility
test, bacterial endotoxin)
product Accuracy, precision (repeatability) and Specificity.
Manufacturer of API M/s Shandong Anxin Pharmaceutical Co. Ltd., No. 849, Dongjia Town, Licheng
District, Jinan, China
API Lot No. RA 2014A
Description of Pack Clear Glass ampoule type-I, 2mlx1’s
Batch No. KS/I-T01 KS/I-T02 KS/I-T03
Batch Size 1000 ampoule 1000 ampoule 1000 ampoule
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Not submitted
3. Documents for the procurement of API with Firm has submitted copy of clearance certificate for import
approval from DRAP (in case of import). of 4.5kg Amikacin sulphate from M/s Shandong Anxin
Pharmaceutical Co. Ltd., China dated 07-06-2022.
However the clearance certificate is not attested by AD
(I&E) DRAP field office.
4. Data of stability batches will be supported by Firm have submitted data of stability batches supported by
attested respective documents like respective documents like chromatograms, Raw data
and humidity monitoring of stability chambers monitoring of stability chambers (accelerated conditions)
XI
1.5.2  Submit your label claim as per reference formulation along with submission of 
applicable fee
1.5.9  Provide evidence of applied formulation in reference regulatory authorities which were 
approved by registration board in its 275th meeting
1.6.5 Valid GMP certificate / DML of the Drug Substance manufacturer issued by relevant 
2.3.R.1  Provide copy of Batch Manufacturing Record (BMR) for all the batches of drug 
3.2.S.4  Unsigned copies of drug substance specification and analytical procedure used for 
routine testing of drug substance by drug product manufacturer is submitted
 Justification is required for not including test for sulphate in drug substance
specifications by drug substance manufacturer as recommended by BP monograph
 Justification is required for selecting different chromatographic conditions (mobile
phase composition, wavelength, column oven temperature, run time) by drug product
manufacturer for drug substance (BP Monograph) than that recommended by drug
substance manufacturer
 Justification is required as whether the drug substance follow BP specifications or USP
specifications as both are mentioned on COA provided by drug substance manufacturer
in batch analysis
3.2.S.5  COA of primary / secondary reference standard including source and lot number shall 
be provided.
3.2.P.2  Justification shall be submitted for not performing pharmaceutical equivalence studies 
against the innovator product
 Justification is required for not performing the pH test for applied product in
pharmaceutical equivalence studies
 Submit the image/picture/snapshot of innovator /reference/comparator pack against
which Pharmaceutical equivalence/Comparative dissolution profile studies have been
performed and shall reveal the details of brand name, manufacturer, batch# and expiry
date of the innovator /reference/comparator product
3.2.P.5  Unsigned copies of finished product specifications and analytical procedure is 
submitted
3.2.P.6  COA of primary / secondary reference standard including source and lot number used 
for the analysis for trial batches shall be submitted
3.2.P.8  Submit documents for the procurement of API with approval from DRAP 
 Justification shall be submitted as the trial batches are manufactured before the import
of API.
 Label claim per injection is 250mg while calculated amount in assay test in raw data
sheets of all batches at initial time point is more than 500mg, clarify
 Label claim per injection mention in raw data sheets at 3rd month time point & 6th
month time point at both real time and accelerated conditions of all batches is 500mg
while applied product contains 250mg/2ml, clarify
 Chromatograms, Raw data sheets, COA, summary data sheets etc. are not attested
chambers (real time) is not submitted
Case No. 16: Registration applications of Human Drugs on form 5F (New sections):
M/s Curatech Pharma Pvt. Ltd., 35-Km, Multan Road, Lahore
approved the grant of following four additional sections to M/s Curatech Pharma Pvt. Ltd., 35-Km, Multan
Road, Lahore under Drug Manufacturing License No. 000619 (Formulation) vide approval letter No. F. 1-
4/2002-Lic (Vol-I) dated 22nd December 2020.
S No. Section
1. Syrup/Suspension (General) Section (Revised New)
2. Capsule (Cephalosporin) Section (New)
3. Dry Powder for Suspension (Cephalosporin) Section (New)
4. Dry Powder for Injection (Cephalosporin) Section (New)

740. Name, address of Applicant / Marketing M/s Curatech Pharma (Pvt.) Ltd., 12 Baqir Lane,
Authorization Holder Canal View Society Canal Road, Lahore
Name, address of Manufacturing site. M/s Curatech Pharma (Pvt.) Ltd., 35-Km, Multan
Road, Lahore
☐ Importer
GMP status of the Finished product manufacturer Firm has submitted copy of GMP certificate dated 08-
04-2020 based on inspection conducted on 19-02-
2020.
additional section dated 22-12-2020 specifying
Capsule Cephalosporin New section.
☐ Export sale
The proposed proprietary name / brand name Curagon 250mg Capsules
Pharmaceutical ingredient (API) per unit Cephalexin …………..….250mg
Pharmacotherapeutic Group of (API) Cephalosporin-Antibiotics
Reference to Finished product specifications USP specifications
The status in reference regulatory authorities KEFLEX (250mg, 500mg, 750mg) capsule USFDA
Approved
product was not discontinued or withdrawn for safety
or effectiveness reasons**
Keflex Capsules 250mg MHRA Approved
For generic drugs (me-too status) Keflex Capsule 250mg by M/s AGP Ltd.,
(Reg#98686)
Name and address of API manufacturer. M/s Pharmagen Limited., Kot Nabi Bukshwala, 34-
Km Ferozepur Road, Lahore
drug product.
Module III (Drug Substance) Firm has submitted detailed drug substance data
Stability studies Firm has submitted stability study data of 3 batches
of drug substance at both accelerated as well as real
30°C ± 2°C / 65% ± 5% RH for 36 months.
Module-III (Drug Product): Firm has submitted data of drug product including
Pharmaceutical equivalence and comparative Firm has submitted pharmaceutical equivalence of
dissolution profile their product against the product Ceporex capsule
250mg by M/s GSK Pakistan Ltd by performing
quality tests (Description, identification, average
weight, disintegration, dissolution, assay).
against the product Ceporex capsule 250mg by M/s
GSK Pakistan Ltd in 0.1N HCl (pH 1.2) Acetate
buffer (pH 4.5), & Phosphate Buffer (pH 6.8).
Analytical method validation/verification of product Firm has submitted method verification studies
including Accuracy, precision (repeatability) and
Specificity.
Manufacturer of API M/s Pharmagen Limited., Kot Nabi Bukshwala, 34-Km Ferozepur Road,
Lahore
API Lot No. 00214/013/2021
Description of Pack Polished capsule of standard size filled with white to slightly yellow color
(Container closure system) powder in Alu-Alu blistered packed in unit carton
Batch No. TR-CEP-24 TR-CEP-25 TR-CEP-26
Batch Size 1000 1000 1000
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API The firm has submitted copy of cGMP certificate of
manufacturer issued by concerned regulatory M/s Pharmagen Limited., Kot Nabi Bukshwala, 34-
authority of country of origin. Km Ferozepur Road, Lahore issued on 02-09-2020
based on inspection conduction on 22-06-2020 and
valid upto two years from the date of inspection
3. Documents for the procurement of API with approval Firm has submitted copy of proforma invoice from
from DRAP (in case of import). M/s Pharmagen Limited dated 30/04/2021 for
purchase of Cephalexin (compacted) 3kg.
respective document like chromatograms, Raw data by attested respective documents like chromatograms,
5. Compliance Record of HPLC software 21CFR & Compliance Record of HPLC software 21CFR &
audit trail reports on product testing audit trail reports on product testing is submitted
6. Record of Digital data logger for temperature and Record of Digital data logger for temperature and
humidity monitoring of stability chambers (real time humidity monitoring of stability chambers (real time
and accelerated) and accelerated) is submitted
1.5.2  Submit your label claim as per reference  The firm has revised label claim as per reference
formulation considering the hydrated form along formulation considering the hydrated form
with submission of applicable fee along with submission of Rs. 30000/- on deposit
slip#39867954. The revised label claim is as
under:
Each capsule contains:
Cephalexin monohydrate equivalent to
Cephalexin…………..….250mg
1.3.5  GMP certificate / GMP inspection report of  The firm has submitted the same previously
manufacturing unit conducted with in last three submitted copy of cGMP certificate along with
years a copy of request letter dated 08-02-2022 made
to area FID & Area Assistant Director (I&E) for
renewal of cGMP and conduction of inspection.
1.6.5  Valid GMP certificate / DML of the Drug  The firm has submitted copy of cGMP
Substance manufacturer issued by relevant certificate of M/s Pharmagen Limited., Kot Nabi
regulatory authority of country of origin is required Bukshwala, 34-Km Ferozepur Road, Lahore
issued on 22-11-2022 based on inspection
conduction on 18-11-2022 and valid upto two
years from the date of inspection
analytical procedures used for routine testing of the and analytical procedures used for routine
Drug substance by Drug Product manufacturer is testing of the Drug substance by Drug Product
required. manufacturer is submitted.
 Analytical Method Verification studies including  Analytical Method Verification studies
specificity, accuracy and repeatability (method including specificity, accuracy and repeatability
precision) performed by the Drug Product (method precision) performed by the Drug
manufacturer for drug substance(s) shall be Product manufacturer for drug substance is
submitted. submitted.
3.2.P.1  Qualitative composition of applied formulation is  The firm submitted that composition of applied
not similar to innovator / reference product. formulation is same as per the reference
Clarification shall be submitted formulation ceporex 250mg capsule and
Applied product KEFLEX capsule submitted evidence of reference formulation
Cephalexin Cephalexin ceporex 250mg capsule.
Magnesium Carboxymethylcellulose  Firm has submitted revised pharmaceutical
stearate sodium equivalence report of their product against the
Blue/blue empty Microcrystalline product Ceporex capsule 250mg by M/s GSK
shell size 2 cellulose, Pakistan Ltd containing test for uniformity of
Dimethicone, dosage units.
Magnesium stearate,  Firm has submitted values of f2 factor in CDP
D&C Yellow No. 10, studies which are in acceptable range.
FD&C Blue No. 1,  The image/picture/snapshot of innovator
FD&C Yellow No. 6, /reference/comparator pack against which
Gelatin, Pharmaceutical equivalence/Comparative
Titanium dioxide. dissolution profile studies have been performed
is submitted
 Justification is required for not performing
uniformity of dosage units test in pharmaceutical
equivalence as recommended by USP monograph
 Submit the values of f2 factor in CDP studies
 Submit the image/picture/snapshot of innovator
/reference/comparator pack against which
Pharmaceutical equivalence/Comparative
dissolution profile studies have been performed
and shall reveal the details of brand name,
manufacturer, batch# and expiry date of the
innovator /reference/comparator product
3.2.P.6 Clarification is required whether the same Reference  The firm has submitted complete trial of the
Standards or Materials of cephalexin was used for COAs of reference standards that were used
test and analysis of drug product as it is mentioned throughout testing of stability studies. The firm
on the COA of Reference Standards or Materials that has submitted COAs of five reference standard
it is to be used before 26th September, 2021 while that were used during stability testing.
drug product stability testing has been performed
subsequent to this date.
Decision: Approved with following Label claim:
Cephalexin monohydrate equivalent to Cephalexin…………..….250mg
 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.
741. Name, address of Applicant / Marketing M/s Curatech Pharma (Pvt.) Ltd., 12 Baqir Lane,
Authorization Holder Canal View Society Canal Road, Lahore
Name, address of Manufacturing site. M/s Curatech Pharma (Pvt.) Ltd., 35-Km, Multan
Road, Lahore
☐ Importer
04-2020 based on inspection conducted on 19-02-
2020.
additional section dated 22-12-2020 specifying
Capsule Cephalosporin New section.
☐ Export sale
The proposed proprietary name / brand name Curagon 500mg Capsules
Pharmaceutical ingredient (API) per unit Cephalexin …………..….500mg
The status in reference regulatory authorities KEFLEX (250mg, 500mg, 750mg) capsule USFDA
Approved
product was not discontinued or withdrawn for safety
or effectiveness reasons**
Keflex Capsules 500mg MHRA Approved
For generic drugs (me-too status) Keflex Capsule 500mg by M/s AGP Ltd.,
(Reg#98687)
Name and address of API manufacturer. M/s Pharmagen Limited., Kot Nabi Bukshwala, 34-
Km Ferozepur Road, Lahore
drug product.
Module III (Drug Substance) Firm has submitted detailed drug substance data
Stability studies Firm has submitted stability study data of 3 batches
of drug substance at both accelerated as well as real
30°C ± 2°C / 65% ± 5% RH for 36 months.
Pharmaceutical equivalence and comparative Firm has submitted pharmaceutical equivalence of
dissolution profile their product against the product Ceporex capsule
500mg by M/s GSK Pakistan Ltd by performing
quality tests (Description, identification, average
weight, disintegration, dissolution, assay).
against the product Ceporex capsule 500mg by M/s
GSK Pakistan Ltd in 0.1N HCl (pH 1.2) Acetate
buffer (pH 4.5), & Phosphate Buffer (pH 6.8).
Specificity.
Manufacturer of API M/s Pharmagen Limited., Kot Nabi Bukshwala, 34-Km Ferozepur Road,
Lahore
API Lot No. 00214/013/2021
Description of Pack Polished capsule of standard size filled with white to offwite color powder
(Container closure system) in Alu-Alu blistered packed in unit carton
Batch Size 1000 1000 1000
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API The firm has submitted copy of cGMP certificate of
manufacturer issued by concerned regulatory M/s Pharmagen Limited., Kot Nabi Bukshwala, 34-
authority of country of origin. Km Ferozepur Road, Lahore issued on 02-09-2020
based on inspection conduction on 22-06-2020 and
valid upto two years from the date of inspection
3. Documents for the procurement of API with approval Firm has submitted copy of proforma invoice from
from DRAP (in case of import). M/s Pharmagen Limited dated 30/04/2021 for
purchase of Cephalexin (compacted) 3kg.
5. Compliance Record of HPLC software 21CFR & Compliance Record of HPLC software 21CFR &
audit trail reports on product testing audit trail reports on product testing is submitted
1.1  Copy of fee challan is submitted…original fee  Firm has submitted copy of online DRAP
challan shall be submitted verified fee challan No#671147973107.
1.5.2  Submit your label claim as per reference  The firm has revised label claim as per
formulation considering the hydrated form along reference formulation considering the
with submission of applicable fee hydrated form along with submission of Rs.
30000/- on deposit slip#37593881707. The
revised label claim is as under:
Cephalexin monohydrate equivalent to
Cephalexin…………..….500mg
1.3.5  GMP certificate / GMP inspection report of  The firm has submitted the same previously
manufacturing unit conducted with in last three submitted copy of cGMP certificate along
years with a copy of request letter dated 08-02-2022
made to area FID & Area Assistant Director
(I&E) for renewal of cGMP and conduction of
inspection.
1.6.5  Valid GMP certificate / DML of the Drug  The firm has submitted copy of cGMP
Substance manufacturer issued by relevant certificate of M/s Pharmagen Limited., Kot
regulatory authority of country of origin is required Nabi Bukshwala, 34-Km Ferozepur Road,
Lahore issued on 22-11-2022 based on
inspection conduction on 18-11-2022 and
valid upto two years from the date of
inspection
analytical procedures used for routine testing of the and analytical procedures used for routine
Drug substance by Drug Product manufacturer is testing of the Drug substance by Drug Product
required. manufacturer is submitted.
 Analytical Method Verification studies including  Analytical Method Verification studies
specificity, accuracy and repeatability (method including specificity, accuracy and
precision) performed by the Drug Product repeatability (method precision) performed by
manufacturer for drug substance(s) shall be the Drug Product manufacturer for drug
submitted. substance is submitted.
3.2.P.1  Qualitative composition of applied formulation is  The firm submitted that composition of
not similar to innovator / reference product. applied formulation is same as per the
Clarification shall be submitted reference formulation ceporex 500mg capsule
Applied product KEFLEX capsule and submitted evidence of reference
Cephalexin Cephalexin formulation ceporex 500mg capsule.
Magnesium Carboxymethylcellulose  Firm has submitted revised pharmaceutical
stearate sodium equivalence report of their product against the
Blue/blue empty Microcrystalline product Ceporex capsule 500mg by M/s GSK
shell size 2 cellulose, Pakistan Ltd containing test for uniformity of
Dimethicone, dosage units.
Magnesium stearate,  Firm has submitted values of f2 factor in CDP
D&C Yellow No. 10, studies which are in acceptable range.
FD&C Blue No. 1,  The image/picture/snapshot of innovator
FD&C Yellow No. 6, /reference/comparator pack against which
Gelatin, Pharmaceutical equivalence/Comparative
Titanium dioxide. dissolution profile studies have been
 Justification is required for not performing performed is submitted
uniformity of dosage units test in pharmaceutical
equivalence as recommended by USP monograph
 Submit the image/picture/snapshot of innovator
/reference/comparator pack against which
Pharmaceutical equivalence/Comparative
dissolution profile studies have been performed
and shall reveal the details of brand name,
manufacturer, batch# and expiry date of the
innovator /reference/comparator product
3.2.P.6 Clarification is required whether the same Reference  The firm has submitted complete trial of the
Standards or Materials of cephalexin was used for COAs of reference standards that were used
test and analysis of drug product as it is mentioned throughout testing of stability studies. The
on the COA of Reference Standards or Materials that firm has submitted COAs of five reference
it is to be used before 26th September, 2021 while standard that were used during stability
drug product stability testing has been performed testing.
subsequent to this date.
Decision: Decision: Approved with following Label claim:
Cephalexin monohydrate equivalent to Cephalexin…………..….500mg
 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.
742. Name, address of Applicant / Marketing M/s Curatech Pharma (Pvt.) Ltd., 12 Baqir Lane, Canal
Authorization Holder View Society Canal Road, Lahore
Name, address of Manufacturing site. M/s Curatech Pharma (Pvt.) Ltd., 35-Km, Multan Road,
Lahore
☐ Importer
04-2020 based on inspection conducted on 19-02-2020.
Evidence of approval of manufacturing facility Firm has submitted copy of letter of grant of additional
section dated 22-12-2020 specifying dry powder for
injection (Cephalosporin) New section.
☐ Export sale
The proposed proprietary name / brand name Rivoceph 500mg Injection
Pharmaceutical ingredient (API) per unit Cefepime Hydrochloride L-Arginine …..500mg
Proposed Pack size 1’s vial of 500mg
The status in reference regulatory authorities MAXIPIME (500mg, 1g, 2g) for injection USFDA
Approved
For generic drugs (me-too status) Maxipime 500mg Injection by M/s GSK Pakistan
Limited (Reg#25548)
Name and address of API manufacturer. Orchid Pharma Ltd., Plot No. 121-128, 128-133, 138-
151, 159-164, SIDCO Industrial Estate, Alathur,
Kancheepuram District-603 110, Tamilnadu, India.
of drug substance and drug product.
Module III (Drug Substance) Firm has submitted detailed drug substance data related
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
5% RH for 36 months. However the results are not
readable
Pharmaceutical equivalence and comparative Firm has submitted pharmaceutical equivalence of their
dissolution profile product against the product Celfime 500mg Injection
manufactured by Norwich Pharmaceuticals by
performing quality tests (Description, identification,
clarity of solution, pH, B.E.T., Sterility, assay).
Specificity.
Manufacturer of API Orchid Pharma Ltd., Plot No. 121-128, 128-133, 138-151, 159-164, SIDCO
Industrial Estate, Alathur, Kancheepuram District-603 110, Tamilnadu,
India.
API Lot No. CPAZ210021
Description of Pack A white to pale yellow colored free flowing powder filled in clear glass vial
(Container closure system) with rubber stopper and aluminium flip off seal.
Real Time: 0, 3, 6 ,9,12 (Months)
No. of Batches 03
manufacturer issued by concerned regulatory Orchid Pharma Ltd., Plot No. 121-128, 128A-133, 138-
authority of country of origin. 151, 159-164, SIDCO Industrial Estate, Alathur,
Kancheepuram District-600110, India., issued by
Director of Drugs Control, Tamilnadu India valid upto
31-12-2023.
3. Documents for the procurement of API with approval Firm has submitted copy of commercial invoice No.
from DRAP (in case of import). 90019504 dated 05-07-2021 for import of Cefepime
HCl L-Arginine Sterile 10kg (Batch#CPAZ210021).
However, the invoice is not attested by AD (I&E) field
office
5. Compliance Record of HPLC software 21CFR & Compliance Record of HPLC software 21CFR & audit
audit trail reports on product testing trail reports on product testing is submitted
1.5.2  Submit your label claim as per reference formulation considering the salt form and 
arginine content along with submission of applicable fee
1.3.5  GMP certificate / GMP inspection report of manufacturing unit conducted with in last 
three years
 Justification is required for not performing test for Arginine content in batch analysis
by drug product manufacturer as recommended by drug substance manufacturer
 Provide Certificate of Analysis of relevant batch of Drug Substance performed by Drug
Substance manufacturer used during product development and stability studies
3.2.S.7  Submit readable copy of stability study of drug substance performed at accelerated and 
real time conditions
3.2.P.2  Justification shall be submitted for not performing pharmaceutical equivalence studies 
against the innovator product
3.2.P.6  COA of Reference Standards or Materials of cefepime states that it is to be used before 
12/04/2019. Clarification is required whether the same Reference Standards or
Materials was used for test and analysis of drug product as drug product stability
testing has been performed subsequent to this date.
 COA of Reference Standards or Materials of Arginine states that it is to be used before
08/03/2019. Clarification is required whether the same Reference Standards or
Materials was used for test and analysis of drug product as drug product stability
3.2.P.8  Batch No. of API mentioned on stability summary sheet is CPAZ21/100/2021 while 
Batch No. of API mentioned on COA of drug product manufacturer is CPAZ210021,
clarify?
 Submit documents for procurement of API with approval from DRAP
 Check dispensed quantity
Lahore
☐ Importer
GMP status of the Finished product Firm has submitted copy of GMP certificate dated 08-04-
manufacturer 2020 based on inspection conducted on 19-02-2020.
injection (Cephalosporin) New section.
☐ Export sale
The proposed proprietary name / brand name Rivoceph 1g Injection
Pharmaceutical ingredient (API) per unit Cefepime Hydrochloride L-Arginine….…..1g
Proposed Pack size 1’s vial of 1g
The status in reference regulatory authorities MAXIPIME (500mg, 1g, 2g) for injection USFDA
Approved
For generic drugs (me-too status) Maxipime 1g Injection by M/s GSK Pakistan Limited
(Reg#25549)
Name and address of API manufacturer. Orchid Pharma Ltd., Plot No. 121-128, 128-133, 138-
151, 159-164, SIDCO Industrial Estate, Alathur,
Kancheepuram District-603 110, Tamilnadu, India.
Module III (Drug Substance) Firm has submitted detailed drug substance data related
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 30°C ± 2°C / 65% ± 5% RH
for 36 months. However the results are not readable
procedures, verification of analytical procedures, batch
standard or materials, container closure system and
stability study.
dissolution profile product against the product Celfime 1g Injection
manufactured by Norwich Pharmaceuticals by
performing quality tests (Description, identification,
clarity of solution, pH, B.E.T., Sterility, assay).
Manufacturer of API Orchid Pharma Ltd., Plot No. 121-128, 128-133, 138-151, 159-164, SIDCO
Industrial Estate, Alathur, Kancheepuram District-603 110, Tamilnadu, India.
API Lot No. CPAZ210021
Description of Pack A white to pale yellow colored free flowing powder filled in clear glass vial
(Container closure system) with rubber stopper and aluminium flip off seal.
Real Time: 0, 3, 6 ,9,12 (Months)
No. of Batches 03
manufacturer issued by concerned regulatory Orchid Pharma Ltd., Plot No. 121-128, 128A-133, 138-
authority of country of origin. 151, 159-164, SIDCO Industrial Estate, Alathur,
Kancheepuram District-600110, India., issued by
Director of Drugs Control, Tamilnadu India valid upto 31-
12-2023.
3. Documents for the procurement of API with Firm has submitted copy of commercial invoice No.
approval from DRAP (in case of import). 90019504 dated 05-07-2021 for import of Cefepime HCl
L-Arginine Sterile 10kg (Batch#CPAZ210021).
However, the invoice is not attested by AD (I&E) field
office
attested respective document like chromatograms, attested respective documents like chromatograms, Raw
Raw data sheets, COA, summary data sheets etc. data sheets, COA, summary data sheets etc.
5. Compliance Record of HPLC software 21CFR & Compliance Record of HPLC software 21CFR & audit
audit trail reports on product testing trail reports on product testing is submitted
humidity monitoring of stability chambers (real humidity monitoring of stability chambers (real time and
time and accelerated) accelerated) is submitted
XI
1.5.2  Submit your label claim as per reference formulation considering the salt form and 
arginine content along with submission of applicable fee
1.3.5  GMP certificate / GMP inspection report of manufacturing unit conducted with in 
last three years
3.2.S.4  Copies of the Drug substance specifications and analytical procedures used for 
routine testing of the Drug substance by Drug Product manufacturer is required.
 Justification is required for not performing test for Arginine content in batch
analysis by drug product manufacturer as recommended by drug substance
manufacturer
 Provide Certificate of Analysis of relevant batch of Drug Substance performed by
Drug Substance manufacturer used during product development and stability
studies
3.2.S.7  Submit readable copy of stability study of drug substance performed at accelerated 
and real time conditions
3.2.P.2  Justification shall be submitted for not performing pharmaceutical equivalence 
studies against the innovator product
3.2.P.6  COA of Reference Standards or Materials of cefepime states that it is to be used 
before 12/04/2019. Clarification is required whether the same Reference Standards
or Materials was used for test and analysis of drug product as drug product stability
 COA of Reference Standards or Materials of Arginine states that it is to be used
before 08/03/2019. Clarification is required whether the same Reference Standards
or Materials was used for test and analysis of drug product as drug product stability
3.2.P.8  Batch No. of API mentioned on stability summary sheet is CPAZ/2100/2021 while 
Batch No. of API mentioned on COA of drug product manufacturer is
CPAZ210021, clarify?
 Check dispensed quantity
Lahore
☐ Importer
suspension (Cephalosporin) New section.
☐ Export sale
The proposed proprietary name / brand name Centric 40mg/5ml Dry Powder Suspension
Pharmaceutical ingredient (API) per unit Cefpodoxime Proxetil ………40mg
Pharmaceutical form of applied drug Suspension
Pharmacotherapeutic Group of (API) Cephalosporin-ANTIBIOTICS
Proposed Pack size 1x50ml
The status in reference regulatory authorities Cefpodoxime Proxetil 40mg/5ml Powder for Oral
Suspension MHRA Approved
For generic drugs (me-too status) Carelox Oral Suspension 40mg/5ml by M/s Nabiqasim
Industries (Reg#82243)
Name and address of API manufacturer. M/s Dhanuka Laboratories Ltd., 7 Km, Old Manesar Road
Village Mohammedpur, Gurgaon- 122004 Haryana
INDIA
substance.
Stability studies Firm has submitted stability study data of 3 batches of drug
substance at both accelerated as well as real time
for 36months.
(Batches: CPP#009/07, CPP#010/07, CPP#011/07)
Module-III (Drug Product): Firm has submitted data of drug product including its
verification of analytical procedures, batch analysis,
dissolution profile product against the product Orelox 40mg/5ml suspension
by M/s Sanofi-aventis Pakistan by performing quality tests
(Description, water determination, pH, assay).
Firm has submitted CDP results of their product against the
product Orelox 40mg/5ml suspension by M/s Sanofi-
aventis Pakistan in 0.1N HCl (pH 1.2) Acetate buffer (pH
4.5), & Phosphate Buffer (pH 6.8).
Manufacturer of API M/s Dhanuka Laboratories Ltd., 7 Km, Old Manesar Road Village
Mohammedpur, Gurgaon- 122004 Haryana INDIA
API Lot No. CPP-2107011
Description of Pack White to pale yellow or light brown powder filled in HDPE bottle
Real Time: 0, 3, 6,9,12 (Months)
Batch Size 1900 Bottles 1900 Bottles 1900 Bottles
No. of Batches 03
manufacturer issued by concerned regulatory Dhanuka Laboratories Ltd., 7 Km, Old Manesar Road
authority of country of origin. Village Mohammedpur, Gurgaon - 122004 Haryana India.,
issued by Food & Drugs Administration Haryana India
valid upto three years from the date of issue (date of issue
(28/12/2018).
approval from DRAP (in case of import). SO/GE/2122/0029 dated 15-07-2021 for import of
Cefpodoxime Proxetil USP Micronise 02kg (Batch#CPP-
2107011). However, the invoice is not attested by AD
(I&E) field office
attested respective document like attested respective documents like chromatograms, Raw
5. Compliance Record of HPLC software 21CFR Compliance Record of HPLC software 21CFR & audit trail
& audit trail reports on product testing reports on product testing is submitted
and humidity monitoring of stability chambers monitoring of stability chambers (real time and
(real time and accelerated) accelerated) is submitted
XI
1.5.2  Submit your label claim as per reference formulation considering the salt factor along 
with submission of applicable fee
three years
1.6.5  Details of drug substance manufacturer in this section shall be submitted 
 Submit valid GMP certificate / DML of the Drug Substance manufacturer issued by
relevant regulatory authority of country of origin
 Clarification is required as Batch No. of API mentioned on COA of drug substance
manufacturer is CPP-2107011while Batch No. of API mentioned on COA of drug
product manufacturer is CPP-12107011
3.2.P.1  Qualitative composition of applied formulation is not similar to innovator / reference 
product. Clarification shall be submitted
3.2.P.2  Justification shall be submitted for not performing the test for uniformity of dosage 
units and deliverable volume in pharmaceutical equivalence studies as recommended
by USP monograph
3.2.P.5  Justification is required for not performing test for deliverable volume in batch analysis 
by drug product manufacturer as recommended by USP monograph
3.2.P.8  Batch No. of API mentioned on stability summary sheet is CPP-12107011 while Batch 
No. of API mentioned on COA of drug substance manufacturer is CPP-2107011,
clarify?
745. Name, address of Applicant / Marketing M/s Curatech Pharma (Pvt.) Ltd., 12 Baqir Lane, Canal View
Authorization Holder Society Canal Road, Lahore
Lahore
☐ Importer
Evidence of approval of manufacturing Firm has submitted copy of letter of grant of additional
facility section dated 22-12-2020 specifying dry powder for injection
(Cephalosporin) New section.
☐ Export sale
The proposed proprietary name / brand Bril 500mg Injection
name
Pharmaceutical ingredient (API) per unit Cefazolin (as Sodium)………..…...500mg
Proposed Pack size 1’s vial of 500mg
The status in reference regulatory SRATOP 0.5g cefazolin (as sodium) 0.5g powder for
authorities injection vial TGA Approved
For generic drugs (me-too status) Kefzol 500mg Inj of M/s AGP Limited (Reg# 3755)
Name and address of API manufacturer. M/s Shandong Lukang Pharmaceutical Co., Ltd., 88 Deyuan
Road, High-Tech Zone, Jining City, Shandong Province, P.R.
China
verification, batch analysis and justification of specification,
process and controls, specifications, analytical procedures
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 30°C ± 2°C / 65% ± 5% RH for 24 months.
(Batches; 2061801001, 2061801002, 2061801003)
verification of analytical procedures, batch analysis,
materials, container closure system and stability study.
dissolution profile product against the product Kefzol 500mg Injection m by M/s
AGP Limited by performing quality tests (Description,
identification, clarity of solution, pH, B.E.T., Sterility,
assay).
Manufacturer of API M/s Shandong Lukang Pharmaceutical Co., Ltd., 88 Deyuan Road, High-Tech
Zone, Jining City, Shandong Province, P.R. China
API Lot No. 2062103004
Description of Pack A white to off white practically odorless, crystalline powder or white to off white
(Container closure system) solid, filled in glass vial with rubber stopper and aluminium flip off seal.
Real Time: 0, 3, 6 , 9, 12, 18 (Months)
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of The firm has submitted copy of cGMP certificate of M/s
API manufacturer issued by concerned Shandong Lukang Pharmaceutical Co., Ltd., No. 88, Xinhua
regulatory authority of country of origin. Road, Zoucheng Industrial Park, Zoucheng City, Shandong
Province China issued by Shandong Food and Drug
Administration China valid upto 08-07-2023.
Firm has submitted copy of DML (License#LU20200470) of
M/s Shandong Lukang Pharmaceutical Co., Ltd., 88, Deyuan
Road, High-tech Zone, Jining, Shandong China issued by
Shandong Provincial Drug Administration valid upto 01-09-
2025
approval from DRAP (in case of import). 2021G126 dated 28-06-2021 for import of Cefazolin Sodium
Sterile 5kg (Batch#2062103004). However, the invoice is not
attested by AD (I&E) field office
attested respective document like attested respective documents like chromatograms, Raw data
testing
and humidity monitoring of stability monitoring of stability chambers (real time and accelerated)
chambers (real time and accelerated) is submitted
XI
1.6.5  Address of Drug substance manufacturer mentioned in submitted GMP certificate is 
different than that mentioned in form 5F section 1.6.5, clarify
three years
 Copies of the Drug substance analytical procedures used for routine testing of the Drug
substance by Drug substance manufacturer is required.
substance shall be submitted.
3.2.S.6  COA of primary / secondary reference standard including source and lot number shall 
be provided.
3.2.P.5  Justification shall be submitted for not including the test for content uniformity and 
particulate matter in finished product specification as per USP monograph
 Justification shall be submitted for not performing the test for content uniformity and
particulate matter in batch analysis of finished product as per USP monograph
3.2.P.6 COA of primary / secondary reference standard including source and lot number used 
for the analysis for trial batches shall be provided.
3.2.P.8 Documents for procurement of API with approval from DRAP shall be submitted 
Agenda of Evaluator PEC-XIII.

Registration applications of locally manufactured New License / New Section on form 5F.
Firm has submitted copy of Acknowledgment of receipt of application for grant of additional section under DML
No. 000465 (Formulations) to M/s Well Care Pharmaceuticals (Pvt.) Ltd., dated 24-11-2021 from Secretary Central
Licensing Board. The letter specifies that CLB in its 283 rd meeting held on 28-10-2021 has approved the grant of
following additional section to M/s Well Care Pharmaceuticals (Pvt.) Ltd., A/7, Small Industrial Estate, Lahore
Road, Sargodha:
1. Capsule (General) New.
746. Name, address of Applicant / Marketing M/s Well care Pharmaceuticals, A/7, Punjab Small
Authorization Holder Industrial Estate, Sargodha.
Name, address of Manufacturing site. M/s Well care Pharmaceuticals, A/7, Punjab Small
Industrial Estate, Sargodha.
☐ Importer
GMP status of the firm Firm has submitted copy of GMP inspection report
conducted by a panel of three members dated 10-09-2021
wherein the panel concluded that M/s Well care pharma was
considered to be operating at satisfactory level of
compliance with GMP guidelines.
Evidence of approval of manufacturing Capsule (general) - New section approved vide letter
facility No.F.1-12/97-Lic (Vol-II) dated 24-11-2021.
☐ Export sale
Dy. No. and date of submission Dy. No. 8793 Dated 30-03-2023.
Details of fee submitted PKR 30,000/- vide slip No. 18335748 Dated 06-02-2023.
The proposed proprietary name / brand Welzole 20mg Capsule.
name
Pharmaceutical ingredient (API) per unit Omeprazole (as omeprazole EC pellets 8.5%)
…………………………………….. 20mg.
Pharmacotherapeutic Group of (API) Proton Pump Inhibitor (PPI).
Pharmaceutical form of applied drug Hard Gelatin capsule.
Reference to Finished product USP specifications.
specifications
Proposed Pack size 2 x 7’s, 1 x 10’s & 10 x 10’s.
The status in reference regulatory Omeprazole 20mg & 40mg capsule (delayed release
authorities pellets), USFDA Approved.
For generic drugs (me-too status) Risek 20mg capsule, M/s Getz pharma Karachi, Reg. No.
019364.
Name and address of API manufacturer. Vision Pharmaceuticals Plot No. 22-23, Industrial Triangle,
Kahuta Road, Islamabad-Pakistan.
structure, manufacturers, description of manufacturing
Module-III Drug Substance: Firm has submitted detailed data for drug substance related
to nomenclature, structure, general properties, solubility,
verification, batch analysis (B. No. OMP736, mfg. date 29-
12-2021) and justification of specification, reference
drug substance.
(Conditions & duration of Stability studies) substance at both accelerated as well as real time conditions.
B. No. (OMP076, OMP073 & OMP090).
Module-III Drug Product: Firm has submitted detailed information of drug product
Pharmaceutical Equivalence and Firm has submitted results of pharmaceutical equivalence of
Comparative Dissolution Profile their product against Risek 40mg capsule manufactured by
Getz Pharma by performing quality tests (Description,
identification, Uniformity of dosage unit, dissolution &
assay).
Firm has submitted CDP against the Risek 20mg capsules
manufactured by Getz Pharma in acid media of pH 1.2 for
02 hours and Phosphate buffer with pH 6.8 for 45 minutes.
Acid media has shown 0% release in both products till 120th
minute while for phosphate buffer the F2 value is in
acceptable range.
Analytical method validation/verification Firm has submitted analytical method validation study
of product reports for drug substance as well as drug product.
Manufacturer of API Vision Pharmaceuticals Plot No. 22-23, industrial triangle, kahuta road,
Islamabad-Pakistan.
API Lot No. Not submitted.
Description of Pack
14 capsules packed in Alu-Alu blister further packed in unit carton.
Batch Size 1400 Capsules 1400 Capsules 1400 Capsules
No. of Batches 03
1. Reference of previous approval of applications Not submitted.
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP Certificate (No. F.3-
manufacturer issued by concerned regulatory 26/2019-Addl.Dir.(QA & LT-1)) dated 31-07-2019
authority of country of origin. issued on the basis of inspection conducted on 11-02-
2019.
3. Documents for the procurement of API with Firm has submitted of copy of invoice mentioning 1 kg
approval from DRAP (in case of import). of Omeprazole EC pellets 8.5% from M/s Vision
Pharmaceuticals.
Submitted.
5. Compliance Record of HPLC software 21CFR & Not Submitted.
6. Record of Digital data logger for temperature and Submitted.
No.
1. 1.3.4 Valid copy of DML of the applicant shall be Firm has initially submitted DML No.
submitted. 000465 with renewal date of 30-06-2004.
Now they have submitted a letter from
Licensing division wherein panel has
been constituted for renewal of their
DML. It is also mentioned in the letter
that their renewal is due w.e.f. 29-06-
2019.
2. 1.6.5 Valid copy of GMP certificate of the drug Firm has submitted copy of GMP
substance manufacturer shall be submitted. certificate No. F. 3-26/2019-Addl. Dir.
(QA&LT-I)-56 dated 22-08-2022 issued
on the basis of inspection conducted on
14-06-2022.
3. 2.3 Table for literature references of the drug Firm has submitted revised and corrected
substance has mentioned drug substance in table for literature references with
different pharmacopoeias. Clarification shall be submission of 7500/- fee vide slip No.
submitted. Revised table for literature 70502699174 dated 10-07-2023.
references with correct information regarding
the drug substance and applicable fee shall be
submitted.
4. 3.2.S.4.1  Specification for the drug substance provided Firm has submitted that mistakenly it was
by the drug substance manufacturer has mentioned as USP specifications.
mentioned USP while there is no monograph Furthermore, they also provided corrected
available for Omeprazole pellets in the USP. specification for the drug substance from
Justify. both the drug substance and finished
product manufacturer.
 Specification of the drug substance by the Submitted.
drug product manufacturer shall be
submitted.
5. 3.2.S.4.2 Analytical procedures for the drug substance by Submitted.
the drug product manufacturer shall be
submitted.
6. 3.2.S.4.3 Verification studies of the drug substance Submitted.
performed by the drug product manufacturer
shall be submitted.
7. 3.2.S.5 Details/COA of the working standard used in Submitted.
the analysis shall be submitted.
8. 3.2.S.7 Real time stability data for drug substance with Submitted.
B. No. OMP090 shall be submitted.
9. 3.2.P.2.2  Justification shall be submitted for Firm has submitted that it was a typo error
performing pharmaceutical equivalence and in newly submitted CDP results they
against Risek 40mg capsule of M/s Getz have corrected the same.
Pharma.
 Justification shall be submitted for not Firm has submitted that comparator
performing CDP & PE against the innovator product i.e. Risek 20 mg was easily
product. available at the time of trial batches
manufacturing, so we used it for the
pharmaceutical equivalence and CDP.
 Graphical representation of the CDP in acidic Firm has submitted that it was a typo error
media has shown full release of the content. and also provided new graphical
Clarification shall be submitted. representation for CDP results in acidic
 medium.
 Details of the comparator i.e. batch number, B. No C03123, Mfg. date 05-2022, Exp.
manufacturing date etc. are not submitted. Date 09-2025 and MRP 483.
10. 3.2.P.5.2  Justification shall be submitted for the Flow Firm has submitted that all the parameters
rate, wavelength (305nm), standard are according to USP. They also provided
preparation, and sample preparation with analytical procedures wherein all these
respect to the USP as all these parameters are parameters are as per USP.
changed from the official pharmacopoeia. However, in initially submitted analytical
procedures, all these parameters were
changed.
11. 3.2.P.8  Stability data sheets shall be as per decision Firm has submitted revised stability data
of 293rd meeting of Registration Board with sheets with API lot number.
inclusion of API lot number.
 Justification shall be submitted for carrying Firm has submitted that it was
dissolution in acidic medium for 60 minute typographical error and actually they have
only. performed dissolution according to USP
 Justification shall be submitted for dissolution till 120 minutes. In revised stability data
in buffer medium with respect to official sheets, they have provided dissolution in
pharmacopoeia as it has mentioned NLT 80% acidic media till 120 minutes.
in 60 minutes. Firm has submitted that by mistakenly
 Justification shall be submitted for not uniformity of dosage unit is not
performing uniformity of dosage units. performed, in real time next time point is
 Compliance Record of HPLC software performed.
21CFR & audit trail reports on product testing Firm has submitted audit trial report.
shall be submitted.
Decision: Registration Board decided to approve the case subject to onsite verification/authenticity of the
product development and stability data by the QA/LT.
747. Name, address of Applicant / Marketing M/s Well care Pharmaceuticals, A/7, Punjab Small
Authorization Holder Industrial Estate, Sargodha.
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. 7971 Dated 21-03-2023.
Details of fee submitted PKR 30,000/- vide slip No. 21475274451 Dated 06-02-
2023.
The proposed proprietary name / brand Tzole 40mg Capsule.
name
Pharmaceutical ingredient (API) per unit Omeprazole (as omeprazole EC pellets 22.5%)
…………………………………….. 40mg.
Pharmacotherapeutic Group of (API) Proton Pump Inhibitor (PPI).
Pharmaceutical form of applied drug Hard Gelatin capsule.
specifications
Proposed Pack size 2 x 7’s.
The status in reference regulatory Omeprazole 20mg & 40mg capsule (delayed release
authorities pellets), USFDA Approved.
For generic drugs (me-too status) Risek 40mg capsule, M/s Getz pharma Karachi, Reg. No.
022109.
verification, batch analysis (B. No. OMP1316, mfg. date 14-
drug substance.
(Conditions & duration of Stability studies) substance at both accelerated as well as real time conditions.
B. No. (OMP065, OMP103 & OMP083).
Comparative Dissolution Profile their product against Risek 40mg capsule manufactured by
assay).
Firm has submitted CDP against the Risek 40mg capsules
manufactured by Getz Pharma in acid media of pH 1.2 for
02 hours and Phosphate buffer with pH 6.8 for 45 minutes.
Acid media has shown 0% release in both products till 120th
minute while for phosphate buffer the F2 value is in
acceptable range.
Islamabad-Pakistan.
API Lot No. Not submitted.
Description of Pack
No. of Batches 03
2019.
approval from DRAP (in case of import). of Omeprazole EC pellets 22.5% from M/s Vision
Pharmaceuticals.
Submitted.
No.
2019.
14-06-2022.
submitted.
4. 3.2.S.4.1  Specification for the drug substance provided Firm has submitted that mistakenly it was
by the drug substance manufacturer has mentioned as USP specifications.
mentioned USP while there is no monograph Furthermore, they also provided corrected
available for Omeprazole pellets in the USP. specification for the drug substance from
Justify. both the drug substance and finished
 Specification of the drug substance by the product manufacturer.
drug product manufacturer shall be Submitted.
submitted.
submitted.
shall be submitted.
7. 3.2.S.5 Details/COA of the working standard used in Submitted.
8. 3.2.S.7 Clear and readable copies of stability data Firm has once again submitted the same
sheets for the drug substance shall be submitted. stability data for the drug substance
which is not in readable form.
9. 3.2.P.2.2  Justification shall be submitted for not Firm has submitted that comparator
performing CDP & PE against the innovator product i.e. Risek 40 mg was easily
product. available at the time of trial batches
manufacturing, so we used it for the
pharmaceutical equivalence and CDP.
 Graphical representation of the CDP in acidic Firm has submitted that it was a typo error
media has shown full release of the content. and also provided new graphical
Clarification shall be submitted. representation for CDP results in acidic
 Details of the comparator i.e. batch number, medium.
manufacturing date etc. are not submitted. B. No C04088, Mfg. date 06-2022, Exp.
Date 06-2025 and MRP 675.
10. 3.2.P.5.2  Justification shall be submitted for the Flow Firm has submitted that all the parameters
rate, wavelength (305nm), standard are according to USP. They also provided
preparation, and sample preparation with analytical procedures wherein all these
respect to the USP as all these parameters are parameters are as per USP.
changed from the official pharmacopoeia. However, in initially submitted
analytical procedures, all these
parameters were changed.
 Justification shall be submitted for carrying Firm has submitted that it was
dissolution in acidic medium for 60 minute typographical error and actually they have
only. performed dissolution according to USP
till 120 minutes. In revised stability data
sheets, they have provided dissolution in
acidic media till 120 minutes.
 Justification shall be submitted for dissolution Firm has submitted that it was
in buffer medium with respect to official typographical error and actually they have
pharmacopoeia as it has mentioned NLT 80% performed dissolution according to USP
in 60 minutes. for 45 minutes and limit is NLT 75%. In
revised stability data sheets, they have
corrected the same.
 Justification shall be submitted for not Firm has submitted that by mistakenly
performing uniformity of dosage units. uniformity of dosage unit is not
performed, in real time next time point is
performed.
 Compliance Record of HPLC software Firm has submitted audit trial report.
21CFR & audit trail reports on product testing
shall be submitted.
748. Name, address of Applicant / M/s Well care Pharmaceuticals, A/7, Punjab Small
Marketing Authorization Holder Industrial Estate, Sargodha.
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. 7972 Dated 21-03-2023
2023.
The proposed proprietary name / brand Mzole 20mg Capsule.
name
Strength / concentration of drug of Each delayed release capsule contains:
Active Pharmaceutical ingredient (API) Esomeprazole (as Esomeprazole Magnesium EC pellets
per unit 8.5%) …………………………………….. 20mg.
Pharmacotherapeutic Group of (API) Proton Pump Inhibitor (PPI)
Pharmaceutical form of applied drug White to almost white EC Pellets filled in hard gelatin
capsule shell.
specifications
Proposed Pack size 2 X 7’s.
The status in reference regulatory Nexium 20mg & 40mg delayed release capsule, USFDA
authorities Approved.
For generic drugs (me-too status) Nexum 20mg Capsule, Getz Pharma, Reg. No. 033890.
closure system and stability studies of drug substance and
drug product.
validation, batch analysis (B. No. EMZ046605, mfg. date
03-01-2022) and justification of specification, reference
drug substance.
studies) The accelerated stability data is conducted at 40°C ± 2°C /
B. No. (EMZ045058, EMZ044632 & EMZ044858)
Comparative Dissolution Profile their product against Nexum 40mg capsule manufactured by
assay) for their product against Nexum 20mg capsules
manufactured by Getz Pharma.
Firm has submitted CDP against the same brand i.e. Nexum
20mg capsules manufactured by Getz Pharma.
Islamabad-Pakistan.
API Lot No. EMZ046605
Description of Pack
No. of Batches 03
2019.
approval from DRAP (in case of import). of Esomeprazole Magnesium EC pellets 8.5% from
M/s Vision Pharmaceuticals.
Submitted.
No.
1. First page of form 5 is not submitted. Submitted.
2. 1.3.4 Valid copy of DML of the applicant shall Firm has initially submitted DML No. 000465
be submitted. with renewal date of 30-06-2004. Now they
have submitted a letter from Licensing division
wherein panel has been constituted for renewal
of their DML. It is also mentioned in the letter
that their renewal is due w.e.f. 29-06-2019.
3. 1.6.5 Valid copy of GMP certificate of the drug Firm has submitted copy of GMP certificate
substance manufacturer shall be No. F. 3-26/2019-Addl. Dir. (QA&LT-I)-56
submitted. dated 22-08-2022 issued on the basis of
inspection conducted on 14-06-2022.
4. 2.3 Table for literature references of the drug Firm has submitted revised and corrected table
substance has mentioned drug substance in for literature references with submission of
different pharmacopoeias. Clarification 7500/- fee vide slip No. 7016326022 dated 05-
shall be submitted. Revised table for 07-2023.
literature references with correct
information regarding the drug substance
and applicable fee shall be submitted.
5. 3.2.S.4.1  Specification for the drug substance Firm has submitted revised drug substance
provided by the drug product specifications wherein they added
manufacturer has no test for identification test.
identification. Justify.
 Specifications provided by the drug Firm has submitted revised drug substance
product manufacturer has no limits for specifications wherein they added both time
dissolution in phosphate buffer and no for acidic medium i.e. 120 minutes and release
time for acidic release. Justification shall limits for buffer medium.
be submitted.
6. 3.2.S.4.2 Analytical procedures for the drug Submitted.
substance by the drug substance
manufacturer shall be submitted.
7. 3.2.S.4.3 Verification studies of the drug substance Not Submitted.
performed by the drug product
Details/COA of the working standard used Submitted.
in the analysis shall be submitted.
8. 3.2.S.7 Accelerated stability data for drug Submitted.
substance with B. No. EMZ045058 shall
be submitted.
9. 3.2.P.1 This section has mentioned 265mg of Firm has submitted that 1mg of Esomeprazole
pellets quantity per capsule. Justification is eq. to 1.1134mg of Esomeprazole
shall be submitted. magnesium trihydrate. Due to this reason
factor of 1.1134 was used.
100/8.4 (pellets potency) x 20 (label claim) x
1.1134 (factor) = 265.09mg/ capsule.
10. 3.2.P.2.2  Justification shall be submitted for Firm has submitted that by mistakenly same
submitting same results of CDP for both CDP was attached. They also provided new
20mg and 40mg formulations. CDP results for the applied formulation with
 Nexum 20mg capsules.
 Justification shall be submitted for Firm has submitted that it was a typo error and
performing pharmaceutical equivalence in newly submitted CDP results they have
against 40mg capsule of M/s Getz corrected the same.
Pharma.
 Justification shall be submitted for not
performing CDP & PE against the No justification submitted against this point.
innovator product.
 Graphical representation of the CDP in
acidic media has shown full release of They also submitted new graphical
the content. Clarification shall be representation for CDP results in acidic
submitted. medium.
 Details of the comparator i.e. batch
number, manufacturing date etc. are not B. No C01021, Mfg. date 09-2021, Exp. Date
submitted. 09-2024 and MRP 297.
11. 3.2.P.3.2 Batch formula has also mentioned 265mg Firm has submitted that 1mg of Esomeprazole
of pellets per capsule. Justification shall be
is eq. to 1.1134mg of Esomeprazole
submitted. magnesium trihydrate. Due to this reason
factor of 1.1134 was used.
100/8.4 (pellets potency) x 20 (label claim) x
1.1134 (factor) = 265.09mg/ capsule.
12. 3.2.P.5.2  Justification shall be submitted for the Firm has submitted that it was typo error and
concentration of standard solution and they also submit new analytical procedures as
sample solution as analytical procedure per USP.
submitted by the firm has mentioned
0.05mg/ml while USP has mentioned
0.04mg/ml.
 Justification shall be submitted for the They once again submitted that it was typo
wavelength applied i.e. 280nm while error and they also submit new analytical
USP has mentioned 302nm. procedures wherein they have corrected the
same as per USP.
13. 3.2.P.5.3 Analytical method verification for the Not submitted.
finished product shall be submitted.
14. 3.2.P.8  Stability data sheets shall be as per Firm has submitted revised stability data sheets
decision of 293rd meeting of Registration with API lot number.
Board with inclusion of API lot number.
 Justify the weight of standard and
sample taken in the calculation formula Firm has submitted that in initially submitted
for the assay test. analytical procedures, there was a typo error.
Now they have provided new analytical
 Justify the wavelength applied in the procedures which are in accordance with the
submitted chromatograms with respect submitted chromatograms.
to the wavelength mentioned in Same as above.
analytical procedure.
749. Name, address of Applicant / M/s Well care Pharmaceuticals, A/7, Punjab Small
Marketing Authorization Holder Industrial Estate, Sargodha.
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. 7973 Dated 21-03-2023
Details of fee submitted PKR 30,000/- vide slip No. 2927054548 Dated 06-02-2023.
The proposed proprietary name / brand Rezole 40mg Capsule.
name
Strength / concentration of drug of Each delayed release capsule contains:
Active Pharmaceutical ingredient (API) Esomeprazole (as Esomeprazole Magnesium EC pellets
per unit 22.5%) …………………………………….. 40mg.
Pharmacotherapeutic Group of (API) Proton Pump Inhibitor (PPI)
Pharmaceutical form of applied drug White to almost white EC Pellets filled in hard gelatin
capsule shell.
specifications
Proposed Pack size 2 X 7’s.
The status in reference regulatory Nexium 20mg & 40mg delayed release capsule, USFDA
authorities Approved.
For generic drugs (me-too status) Nexum 40mg Capsule, Getz Pharma, Reg. No. 033891.
drug product.
validation, batch analysis (B. No. EMZ046595, mfg. date
12-12-2021) and justification of specification, reference
drug substance.
Stability Studies of Drug Substance Firm has only submitted accelerated stability study data of
(Conditions & duration of Stability 3 batches of drug substance. The accelerated stability data
studies) is conducted at 40°C ± 2°C / 75% ± 5% RH for 6 months.
B. No. (EMZ044440, EMZ044265 & EMZ044152)
Comparative Dissolution Profile their product against Nexum 40mg capsule manufactured by
assay) for their product against Nexum 20mg capsules
manufactured by Getz Pharma.
Firm has submitted CDP against the same brand i.e. Nexum
400mg capsules manufactured by Getz Pharma.
Islamabad-Pakistan.
API Lot No. Not mentioned.
Description of Pack
No. of Batches 03
2019.
approval from DRAP (in case of import). of Esomeprazole Magnesium EC pellets 22.5% from
M/s Vision Pharmaceuticals.
Submitted.
No.
1. First page of form 5 is not submitted. Submitted.
2019.
14-06-2022.
submitted.
5. 3.2.S.4.1  Specification for the drug substance provided Firm has submitted revised drug
by the drug product manufacturer has no test substance specifications wherein they
for identification. Justify. added identification test.
 Specifications provided by the drug product
manufacturer has no limits for dissolution in Firm has submitted revised drug
phosphate buffer and no time for acidic substance specifications wherein they
release. Justification shall be submitted. added both time for acidic medium i.e.
120 minutes and release limits for buffer
medium.
the drug substance manufacturer shall be
submitted.
7. 3.2.S.4.3 Verification studies of the drug substance Not Submitted.
shall be submitted.
Details/COA of the working standard used in Submitted.
8. 3.2.S.7 Real time stability study data for drug substance Firm has submitted real time stability
shall be submitted. data sheets for the drug substance,
however, they are not in readable form.
9. 3.2.P.2.2  Justification shall be submitted for submitting Firm has submitted that by mistakenly
same results of CDP for both 20mg and 40mg same CDP was attached. They also
formulations. provided new CDP results for the applied
 Justification shall be submitted for not formulation with Nexum 40mg capsules.
performing CDP & PE against the innovator Firm has submitted that it was a typo error
product. and in newly submitted CDP results they
 Graphical representation of the CDP in acidic have corrected the same.
media has shown full release of the content.
Clarification shall be submitted.
 Details of the comparator i.e. batch number, No justification submitted against this
manufacturing date etc. are not submitted. point.
They also submitted new graphical

representation for CDP results in acidic
medium.
B. No C02032, Mfg. date 03-2022, Exp.

Date 03-2025 and MRP 530.
10. 3.2.P.5.3 Analytical method verification for the finished Not submitted.
product shall be submitted.
 Justify the weight of standard and sample Firm has submitted that in initially
taken in the calculation formula for the assay submitted analytical procedures, there
test. was a typo error. Now they have provided
new analytical procedures which are in
accordance with the submitted
chromatograms.
 Justify the wavelength applied in the Same as above.
submitted chromatograms with respect to the
wavelength mentioned in analytical
procedure.
CLB in its 284th meeting held on 16th December 2021 has considered and approved the grant of following four (04)
additional section to M/s Fynk Pharmaceuticals (Pvt.) Ltd., 19 km, G.T. Road, Kalashah Kaku, Tehsil Ferozwala,
District Sheikhupura;
Capsule (Penicillin). – New.
Oral Dry Powder Suspension (Penicillin). – New.
Dry Powder Injectable (Penicillin). – New.
Dry Powder Injectable (Carbapenem). – New.
Following applications of M/s Fynk Pharma are placed before the Board for consideration.
750. Name, address of Applicant / Marketing M/s Fynk Pharmaceuticals (Pvt.) Ltd., 19 km, G.T.
Authorization Holder Road, Kalashah Kaku, Tehsil Ferozwala, District
Sheikhupura.
Name, address of Manufacturing site. M/s Fynk Pharmaceuticals (Pvt.) Ltd., 19 km, G.T. Road,
Kalashah Kaku, Tehsil Ferozwala, District Sheikhupura.
☐ Importer
GMP status of the firm Firm has submitted copy of GMP certificate No.
198/2022-DRAP (AD-9405944056-789) dated 17-11-
2022 issued on the basis of inspection 14/11/2022.
Evidence of approval of manufacturing Capsule (Penicillin) – New section approved vide letter
facility No. F. 1-63/84-Lic (Vol III) dated 27-12-2021 is
submitted.
☐ Export sale
Dy. No. and date of submission Dy. No 5263 dated 23-02-2023.
2023.
The proposed proprietary name / brand Ampiwell 250mg Capsule.
name
Strength / concentration of drug of Active Each Capsule contains:
Pharmaceutical ingredient (API) per unit Ampicillin as trihydrate …………… 250mg
Pharmacotherapeutic Group of (API) Beta-Lactam Antibacterial, Penicillin.
Pharmaceutical form of applied drug Oral capsule.
Reference to Finished product BP specifications.
specifications
Proposed Pack size 20 capsules.
The status in reference regulatory Ampicillin Capsules BP 250 mg, Crescent Pharma
authorities Limited, MHRA approved.
For generic drugs (me-too status) Penbritin 250mg Capsule, GSK Pakistan, Reg. No.
000188.
Name and address of API manufacturer. M/s Pharmagen Limited, Kot Nabi buksh wala, 34 K.M.
Ferozpur Road, Lahore.
Copy of GMP certificate No. 06/2019-DRAP
(AD/607409-530) dated 11-01-2019 on the basis of
inspection conducted on 08-01-2019 is submitted.
Module-III Drug Substance: Firm has submitted detail of the drug substance including
its nomenclature, structure, general properties, solubility,
verification, batch analysis (B. No. 00003/093/2021, mfg.
date 11-2021 ) and justification of specification, working
drug substance.
Stability Studies of Drug Substance Firm has submitted stability data sheets for the drug
(Conditions & duration of Stability studies) substance. However, the stability data sheets are not in
readable form.
B. No. 00003/001/2018, 00003/002/2018 &
00003/003/2018,
process validation protocols, control of drug product,
Pharmaceutical Equivalence and Firm has submitted comparative dissolution of their
Comparative Dissolution Profile applied formulation with Penbritin 250mg capsule with
B. No. IPBAB in three different mediums of pH 1.2, 4.5
& 6.8. values of the F2 are in acceptable range.
Firm has submitted pharmaceutical equivalence of their
product against the Penbritin 250mg capsule by
performing quality tests od identification, average filled
weight, dissolution and assay.
Analytical method validation/verification of Firm has submitted analytical method validation study
Manufacturer of API M/s Pharmagen Limited, Kot Nabi buksh wala, 34 K.M. Ferozpur Road,
Lahore.
API Lot No. 00003/093/2021.
Description of Pack Almost white granular powder filled in purple and white capsule packed in
(Container closure system) printed Alu - Alu blister of 20 capsules further packed in unit carton.
Batch No. A B C
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. 06/2019-DRAP
manufacturer issued by concerned regulatory (AD/607409-530) dated 11-01-2019 on the basis of
authority of country of origin. inspection conducted on 08-01-2019 is submitted.
3. Documents for the procurement of API with Firm has submitted copy of Proforma invoice No.
approval from DRAP (in case of import). PL/P-INV/HO/866 dated 03-01-2022 wherein they
have purchased 1kg of Ampicillin trihydrate from M/s
Pharmagen Limited. However, the invoice has not
mentioned any batch number and manufacturing date
of the drug substance.
4. Data of stability batches will be supported by Submitted.
Sr. Section Observation Response by the firm
No.
substance manufacturer shall be submitted. certificate No. 129/2020-DRAP
(AD/1998630-530) dated 02-09-2020
issued on the basis of inspection conducted
on 22-06-2020.
GMP certificate is not within last three
years.
2. 2.3 Table for literature references with correct Firm has provided corrected information
information with applicable fee shall be with submission of 7500/- fee vide slip No.
submitted. 7428934818 dated 10-07-2023.
3. 3.2.S.7 Readable copies of the drug substance Not submitted.
stability data sheets shall be submitted.
4. 3.2.P.2.2  Dissolution time is not mentioned in the Firm has submitted that dissolution time is
pharmaceutical equivalence. Justification mentioned in specifications and CDP.
shall be submitted.
 CDP sheets have mentioned Ampicillin Firm has submitted that it was typo error
sodium as drug substance. Justification and they attached updated CDP sheets.
shall be submitted. However, in the updated CDP sheets no
dissolution medium is mentioned.
Furthermore, the values at different time
points are completely different from that
of the originally submitted.
5. 3.2.P.5.1 Justification shall be submitted for adopting Firm has submitted that in BP monograph
all the specifications for the finished of ampicillin capsule, dissolution test has
product from BP while only dissolution test not been given, so they adopted dissolution
is adopted from USP. test from USP.
6. 3.2.P.8  Proforma invoice provided by the firm Firm has submitted new invoice wherein
has not mentioned any batch number and they have added batch number of the
mfg. date. Clarify. material used in trial batches.
 Reference of previous approval of However, the batch number mentioned in
applications with stability study data of COAs and stability data sheet is (B. No.
the firm (if any) shall be submitted. 00003/093/2021) while the new submitted
invoice has mentioned B. No. 00003-
11/093/2021.
Decision: Deferred for following;
 Valid copy of GMP certificate/inspection report conducted within last three years of the drug
substance manufacturer shall be submitted.
 Readable copies of the drug substance stability data sheets shall be submitted.
 Firm will perform Comparative Dissolution of their applied product with innovator product with
complete details of the mediums, time points and details of the innovator product.
 Clarification regarding the API lot number as it is different in COAs, stability data sheets and
submitted invoice.
751. Name, address of Applicant / Marketing M/s Fynk Pharmaceuticals (Pvt.) Ltd., 19 km, G.T. Road,
Authorization Holder Kalashah Kaku, Tehsil Ferozwala, District Sheikhupura.
☐ Importer
198/2022-DRAP (AD-9405944056-789) dated 17-11-
Evidence of approval of manufacturing Dry Powder suspension (Penicillin) – New section
facility approved vide letter No. F. 1-63/84-Lic (Vol III) dated
27-12-2021 is submitted.
☐ Export sale
2023.
The proposed proprietary name / brand Ampiwell Dry Powder Suspension 125mg/5ml.
name
Pharmaceutical ingredient (API) per unit Ampicillin as trihydrate …………… 125mg.
Pharmaceutical form of applied drug Dry Powder Suspension.
specifications
Proposed Pack size 60ml.
The status in reference regulatory Ampicillin 125 mg/5ml Oral Suspension, Kent
authorities Pharmaceuticals Limited, MHRA Approved.
For generic drugs (me-too status) Ampcin 15 mg Dry Suspension, CSH
Pharmaceuticals, Reg. No. 071538.
Name and address of API manufacturer. M/s Zafa Chemie, Raiwind Road Bypass, Sunder
Industrial Estate, Mouza Bhaikot, Tehsil & District
Lahore, Pakistan.
Copy of GMP Certificate No. 79/2020-DRAP
(AD/1992617-228) dated 20-04-2020 issued on the basis
of inspection conducted on 23-10-2019.
verification, batch analysis (B. No. 828, mfg. date 02-
2021 ) and justification of specification, working
drug substance.
for 36 months.
Real time: B. No. 804, 805 & 806.
Accelerated: 808, 809 & 810.
Comparative Dissolution Profile product against the Ampicillin dry powder suspension
with B. No. SM-022, mfg. date 05-2022 manufactured by
M/s Amros Pharmaceuticals by performing quality test of
identification, pH, average filled bottle weight, assay and
microbial count test. Results of both the test product and
reference product are within the specifications limit and
comparable.
Manufacturer of API M/s Zafa Chemie, Raiwind Road Bypass, Sunder Industrial Estate, Mouza
Bhaikot, Tehsil & District Lahore, Pakistan.
API Lot No. 828.
Description of Pack
Amber colour glass sealed labelled bottle securely packed in unit carton.
Batch No. T-001 T-002 T-003
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of GMP Certificate No. 79/2020-DRAP
manufacturer issued by concerned regulatory (AD/1992617-228) dated 20-04-2020 issued on the
authority of country of origin. basis of inspection conducted on 23-10-2019.
3. Documents for the procurement of API with Not submitted.
Sr. Section Observation Response by the firm
No.
1. 1.6.5 Valid copy of GMP certificate of the Firm has once again submitted
drug substance manufacturer shall be Copy of GMP Certificate No.
submitted. 79/2020-DRAP (AD/1992617-228)
dated 20-04-2020 issued on the
basis of inspection conducted on 23-
10-2019.
Not within last three years.
2. 2.3 Table for literature references with Firm has provided corrected
correct information shall be information with submission of
submitted. 7500/- fee vide slip No.
22193240162 dated 10-07-2023.
3. 3.2.S.7 Real time and accelerated stability Firm has once again submitted real
study data of the drug substance for time stability data of the drug
the same batches shall be submitted. substance for the same batches.
Real time: B. No. 804, 805 & 806.
Accelerated: 808, 809 & 810.
Stability study data for same
batches is not provided.
4. 3.2.P.2.2 Justification for not performing the Firm has submitted that innovator
pharmaceutical equivalence test product was not available in the
against the innovator product. market, so they used competitor
product.
5. 3.2.P.8  Stability data sheets as per decision Firm has submitted revised stability
of 293rd meeting of RB with data sheets wherein they have
inclusion of API lot number shall included API lot number in the
be submitted. stability data sheets.
 Justification shall be submitted for Firm has submitted that wavelength
the applied wavelength (230) in the of 230nm was adopted from USP
submitted chromatograms with monograph of Ampicillin.
respect to the analytical procedures However, finished product
and BP (254). specifications, analytical
procedures have mentioned BP
specifications.
 Justification shall be submitted for Firm has submitted that to achieve
the injection volume (20) in the system suitability, they used 20 µl
submitted chromatograms with injection volume as per USP <621>,
respect to the analytical procedures method verification also has been
and BP (50µl). conducted for this variation. They
further submitted that at 11-month
time point they had tested by using
50 µl injection volume and using
254 nm wavelength and found
satisfactory results.
 Raw data sheets for calculation of Firm has submitted that they
ampicillin content at each time attached raw data sheets for
point shall be submitted. calculation of ampicillin content.
However, they have not submitted
any calculation sheets.
 Documents for procurement of API Firm has submitted copy of invoice
shall be submitted. No. 293913 mentioning 10kg
quantity of Ampicillin trihydrate
with batch No. 828.
 Valid copy of GMP certificate/inspection report conducted within last three years of the drug
substance manufacturer shall be submitted.
 Real time and accelerated stability study data of the drug substance for the same batches shall be
submitted.
 Pharmaceutical equivalence test of the applied formulation against the innovator product shall be
submitted.
 Justification shall be submitted for adopting wavelength (230nm) in the submitted chromatograms
while the specification and analytical procedures of the finished product has mentioned BP
specification with wavelength of (254nm).
 Raw data sheets for calculation of ampicillin content at each time point shall be submitted.
Sheikhupura.
☐ Importer
198/2022-DRAP (AD-9405944056-789) dated 17-11-
Evidence of approval of manufacturing Dry powder injectable (Carbapenem). – New section
☐ Export sale
2023.
The proposed proprietary name / brand Morefen 500mg Dry Powder injection.
name
Pharmaceutical ingredient (API) per unit Meropenem as trihydrate …………… 500mg
Pharmacotherapeutic Group of (API) Carbapenem.
Pharmaceutical form of applied drug Powder for injection.
specifications
Proposed Pack size 1’s (one vial packed with 10ml of WFI).
The status in reference regulatory Merrem 500mg & 1gm injection by Pfizer Injectable,
authorities USFDA approved.
For generic drugs (me-too status) Meronem IV 500mg Injection, Pfizer Pakistan, Reg. No.
096203.
Name and address of API manufacturer. Vartika Chemicals & Pharmaceuticals Pvt. Ltd., G1-567,
RIICO Industrial Area, Khushkhera, Bhiwadi – 301019
Dist. Bhiwadi (Rajasthan), India.
controls, tests for impurity & related substances,
batch analysis (MRPS-0422032) and justification of
specification, working standard, container closure system
for 48 months.
Batch No. MRPS-0218002, MRPS-0218003 & MRPS-
0218004.
Comparative Dissolution Profile product against the Meroget 500mg injection, batch No.
9210407003, mfg. date 04-2021manufactured by Getz
pharma by performing quality test pH, Loss on Drying,
Assay of Meropenem, assay of sodium content and
sterility.
Manufacturer of API Vartika Chemicals & Pharmaceuticals Pvt. Ltd., G1-567, RIICO Industrial
Area, Khushkhera, Bhiwadi – 301019 Dist. Bhiwadi (Rajasthan), India.
API Lot No. MRPS-0422032.
Description of Pack
White to off white crystalline powder filled in a glass vial and properly sealed.
Batch No. T-001 T-002 T-003
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP Certificate No.
manufacturer issued by concerned regulatory DC/A-I/2020/1517 dated 09-09-2020 issued by Drug
authority of country of origin. Control Organization, Rajasthan, Jaipur.
Valid till 11-04-2022.
3. Documents for the procurement of API with Not readable.
6. Record of Digital data logger for temperature and Not submitted.
No.
1. First page of Form 5F is not Submitted.
provided.
2. 1.6.5 Valid copy of GMP certificate of Firm has submitted copy of GMP
drug substance manufacturer issued certificate No. DC/A-
by the concerned/relevant regulatory 4/GMP/2022/2804 dated 07-09-2022
authority shall be submitted. issued by Food Safety and Drugs
Control Commissionerate (Drugs
Control Wing) Rajasthan, India valid
till 08-09-2023.
3. 2.3  Revised table for literature Firm has provided corrected
references with correct information information with submission of 7500/-
regarding the drug substance and fee vide slip No. 01832409787 dated
finished product with applicable 10-07-2023.
fee shall be submitted.
 Justify the actual quantity/vial Firm has submitted that actual weight
against mentioned in executed per vial was calculated after
BMR’s the potency of drug adjustment of assay and factor.
substance. Factor = 1.140
Potency = 83.56%
500 x 1.140/83.56 x 100 = 682.14
4. 3.2.S.4.1 Specification of the drug substance Firm has submitted that during
submitted by the drug substance compilation of dossier, specifications
manufacturer are for Ampicillin for ampicillin were attached instead of
sodium instead of Meropenem. Meropenem. They also submitted new
Justification shall be submitted. specification for Meropenem.
5. 3.2.S.4.5 Justification of specification for the Firm has submitted that it was typo
drug substance is for Doxycycline error and they also attached
USP. Justify? justification of specifications for
Meropenem.
6. 3.2.S.7  Clear and readable copies of the Submitted.
stability data sheets for drug
 Stability study data for the drug Firm has submitted that stability for
substance submitted is for drug substance is Meropenem
Meropenem USP only. trihydrate blended with sodium
Justification shall be submitted. carbonate as evident from the
 Stability data sheets for the drug specifications. Drug substance
substance has also not mentioned manufacturer writes product name as
sodium content. Justify. per USP monograph i.e. Meropenem
 Real time stability data is only for USP Sterile.
09 months. Complete real time
stability data shall be submitted. Real time stability study data for 48
months is submitted by the firm.
7. 3.2.P.1 Justify the proposed quantity/vial Firm has submitted that actual weight
against the potency limit of drug per vial was calculated after
substance declared in 3.2.S.4.1. adjustment of assay and factor.
Factor = 1.140
Potency = 83.56%
500 x 1.140/83.56 x 100 = 682.14
8. 3.2.P.2.2  Justification shall be submitted for Firm has submitted that they have also
not performing pharmaceutical performed pharmaceutical equillance
equivalence against the innovator studies against the Meronem injection
product. of M/s Pfizer Pakistan limited.
They also provided the new
 Content uniformity test and pharmaceutical equivalence studies of
particulate matter tests are not their product against the Meronem
performed in the pharmaceutical 500mg injection with batch No.
equivalence studies. Justify? 5B22H31, mfg. date 04-2022 by
performing quality tests including pH,
water content, uniformity of dosage
unit, particulate matter, Assay of
Meropenem, assay of sodium content
and sterility.
9. 3.2.P.8  Evidence of availability of atomic Firm has submitted that they have
absorption spectroscopy shall be attached commercial invoice for
submitted. atomic absorption. However, no such
 Clear and readable copy of the invoice is attached.
clearance certificate for import of Firm has submitted copy of clearance
API shall be submitted. certificate No. E-1393520227361
dated 07-06-2022 mentioning 0.50
grams of Meropenem with batch
number of MRPS-0422032, mfg. date
30-Apr-2022.
However, the actual quantity used in
three trial batches is much more than
the imported.
 Raw data sheets for calculation of Not submitted.
assay of Meropenem and sodium
content at each time interval with
calculation formula shall be
submitted. Firm has submitted that in DRB 323rd
 Reference of previous approval of meeting their two products i.e. Faxcil
applications with stability study 250mg & 500.
data of the firm (if any) shall be Submitted.
submitted.
software 21CFR & audit trail Submitted.
reports on product testing shall be
submitted.
 Record of Digital data logger for
(real time and accelerated) shall be
submitted.

 Evidence of availability of atomic absorption spectroscopy shall be submitted.
 Raw data sheets for calculation of assay of Meropenem and sodium content at each time interval with
calculation formula shall be submitted.
 Justification shall be submitted regarding the quantity of drug substance imported i.e 0.5grams vide
clearance certificate No. E-1393520227361 dated 07-06-2022 against the manufactured six trial
batches of two different strengths of 500mg and 1gm with each trial of 300 vials.
Sheikhupura.
☐ Importer
198/2022-DRAP (AD-9405944056-789) dated 17-11-
Evidence of approval of manufacturing Dry powder injectable (Carbapenem). – New section
☐ Export sale
2023.
The proposed proprietary name / brand Morefen 1gm Dry Powder injection.
name
Pharmaceutical ingredient (API) per unit Meropenem as trihydrate …………… 1gm
Pharmacotherapeutic Group of (API) Carbapenem.
Pharmaceutical form of applied drug Powder for injection.
specifications
Proposed Pack size 1’s (one vial packed with 10ml of WFI).
The status in reference regulatory Merrem 500mg & 1gm injection by Pfizer Injectable,
authorities USFDA approved.
For generic drugs (me-too status) Meronem IV 1gm Injection, Pfizer Pakistan, Reg. No.
096204.
Name and address of API manufacturer. Vartika Chemicals & Pharmaceuticals Pvt. Ltd., G1-567,
RIICO Industrial Area, Khushkhera, Bhiwadi – 301019
Dist. Bhiwadi (Rajasthan), India.
controls, tests for impurity & related substances,
batch analysis (MRPS-0422032) and justification of
specification, working standard, container closure system
for 24 months.
Batch No. MRPS-0521005, MRPS-0521006 & MRPS-
0521005.
Comparative Dissolution Profile product against the Meroget 1gm injection, batch No.
9210407004, mfg. date 04-2021 manufactured by Getz
pharma by performing quality test pH, Loss on Drying,
Assay of Meropenem, assay of sodium content and
sterility.
Manufacturer of API Vartika Chemicals & Pharmaceuticals Pvt. Ltd., G1-567, RIICO Industrial
Area, Khushkhera, Bhiwadi – 301019 Dist. Bhiwadi (Rajasthan), India.
API Lot No. MRPS-0422032.
Description of Pack
White to off white crystalline powder filled in a glass vial and properly sealed.
Batch No. T-001 T-002 T-003
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP Certificate No.
manufacturer issued by concerned regulatory DC/A-I/2020/1517 dated 09-09-2020 issued by Drug
authority of country of origin. Control Organization, Rajasthan, Jaipur.
Valid till 11-04-2022.
3. Documents for the procurement of API with Not readable.
6. Record of Digital data logger for temperature and Not submitted.
No.
1. First page of Form 5F is not Submitted.
provided.
2. 1.6.5 Valid copy of GMP certificate of Firm has submitted copy of GMP
drug substance manufacturer issued certificate No. DC/A-
by the concerned/relevant regulatory 4/GMP/2022/2804 dated 07-09-2022
authority shall be submitted. issued by Food Safety and Drugs
till 08-09-2023.
3. 2.3  Revised table for literature Firm has provided corrected
references with correct information information with submission of 7500/-
regarding the drug substance and fee vide slip No. 01832409787 dated
finished product with applicable 10-07-2023.
fee shall be submitted.
 Justify the actual quantity/vial Firm has submitted that actual weight
against mentioned in executed per vial was calculated after
BMR’s the potency of drug adjustment of assay and factor.
substance. Factor = 1.140
Potency = 83.56%
1000 x 1.140/83.56 x 100 = 1364.29
4. 3.2.S.4.1 Specification of the drug substance Firm has submitted that during
submitted by the drug substance compilation of dossier, specifications
manufacturer are for Ampicillin for ampicillin were attached instead of
sodium instead of Meropenem. Meropenem. They also submitted new
Justification shall be submitted. specification for Meropenem.
5. 3.2.S.4.5 Justification of specification for the Firm has submitted that it was typo
drug substance is for Doxycycline error and they also attached
USP. Justify? justification of specifications for
Meropenem.
6. 3.2.S.7  Clear and readable copies of the Submitted.
stability data sheets for drug
 Stability study data for the drug Firm has submitted that stability for
substance submitted is for drug substance is Meropenem
Meropenem USP only. trihydrate blended with sodium
Justification shall be submitted. carbonate as evident from the
 Stability data sheets for the drug specifications. Drug substance
substance has also not mentioned manufacturer writes product name as
sodium content. Justify. per USP monograph i.e. Meropenem
 Real time stability data is only for USP Sterile.
09 months. Complete real time
stability data shall be submitted. Real time stability study data for 48
months is submitted by the firm.
7. 3.2.P.1 Justify the proposed quantity/vial Firm has submitted that actual weight
against the potency limit of drug per vial was calculated after
substance declared in 3.2.S.4.1. adjustment of assay and factor.
Factor = 1.140
Potency = 83.56%
1000 x 1.140/83.56 x 100 = 1364.29
8. 3.2.P.2.2  Justification shall be submitted for Firm has submitted that they have also
not performing pharmaceutical performed pharmaceutical equillance
equivalence against the innovator studies against the Meronem injection
product. of M/s Pfizer Pakistan limited.
 Content uniformity test and They also provided the new
particulate matter tests are not pharmaceutical equivalence studies of
performed in the pharmaceutical their product against the Meronem
equivalence studies. Justify? 500mg injection with batch No.
5B22H31, mfg. date 04-2022 by
performing quality tests including pH,
water content, uniformity of dosage
unit, particulate matter, Assay of
Meropenem, assay of sodium content
and sterility.
9. 3.2.P.8  Evidence of availability of atomic Firm has submitted that they have
absorption spectroscopy shall be attached commercial invoice for
submitted. atomic absorption. However, no such
 Clear and readable copy of the invoice is attached.
clearance certificate for import of Firm has submitted copy of clearance
API shall be submitted. certificate No. E-1393520227361
dated 07-06-2022 mentioning 0.50
grams of Meropenem with batch
number of MRPS-0422032, mfg. date
30-Apr-2022.
However, the actual quantity used in
 Raw data sheets for calculation of three trial batches is much more than
assay of Meropenem and sodium the imported.
content at each time interval with Not submitted.
calculation formula shall be
submitted.
rd
applications with stability study Firm has submitted that in DRB 323
data of the firm (if any) shall be meeting their two products i.e. Faxcil
submitted. 250mg & 500.
software 21CFR & audit trail Submitted.
submitted.
 Record of Digital data logger for Submitted.
(real time and accelerated) shall be
submitted.
 Evidence of availability of atomic absorption spectroscopy shall be submitted.
 Raw data sheets for calculation of assay of Meropenem and sodium content at each time interval with
calculation formula shall be submitted.
 Justification shall be submitted regarding the quantity of drug substance imported i.e 0.5grams vide
clearance certificate No. E-1393520227361 dated 07-06-2022 against the manufactured six trial
batches of two different strengths of 500mg and 1gm with each trial of 300 vials.
Sheikhupura.
☐ Importer
198/2022-DRAP (AD-9405944056-789) dated 17-11-
☐ Export sale
2023.
The proposed proprietary name / brand Falamox Dry Powder Suspension 125mg/5ml.
name
Pharmaceutical ingredient (API) per unit Amoxicillin as trihydrate …………… 125mg.
Potassium Clavulanate eq. Clavulanic Acid…….
31.25mg.
specifications
Proposed Pack size 60ml, 75ml, 90ml, 100ml.
The status in reference regulatory Augmentin 125 mg/31.25mg Oral Suspension, USFDA
authorities approved.
For generic drugs (me-too status) Augmentin 125 mg/31.25mg, GSK Pakistan, Reg. No.
009264.
Name and address of API manufacturer. Amoxicillin Trihydrate:
Pharmagen Limited; Kot Nabi Bukshwala, 34 Km
Potassium Clavulanate:
Sinopharm Weiqida Pharmaceuticals Co., Ltd.
Economic & Technological Development Zone, First
Medical Zone, Datong, Shanxi, China.
Firm has submitted copy of GMP Certificate (No.
SX20180229) issued by CFDA dated 06-06-2018 valid
till 05-06-2023.
Firm has submitted summarized information for both the
drug substances related to nomenclature, structure,
product.
Module-III Drug Substance: Amoxicillin trihydrate:
Firm has submitted detail of the drug substance including
verification, batch analysis (000120/841/2021) and
substance.
verification, batch analysis (02NB2205007) and
substance.
Stability Studies of Drug Substance Amoxicillin trihydrate:
(Conditions & duration of Stability studies) Stability study conditions:
months.
Batches: (00013/210/2009, 00013/211/2009,
00013/212/2009)
Real time: 5°C ± 3°C for 36 months.
Batches: (NA-201106301, NA-201106302 & NA-
201106303)
Comparative Dissolution Profile product against the Augmentin dry powder suspension
125mg with B. No. PV8L, mfg. date 06-2022
manufactured by M/s GSK Pakistan by performing
quality test of identification, pH, average filled bottle
weight, assay and microbial count test. Results of both the
test product and reference product are within the
specifications limit and comparable.
Manufacturer of API Amoxicillin Trihydrate:
Pharmagen Limited; Kot Nabi Bukshwala, 34 Km Ferozepur Road, Lahore.
Economic & Technological Development Zone, First Medical Zone, Datong,
Shanxi, China.
API Lot No. Not provided.
Description of Pack Amber colour Glass Bottle properly sealed with cap, labelled and packed in
(Container closure system) cardboard carton.
Batch No. T-001 T-002 T-003
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Amoxicillin Trihydrate:
manufacturer issued by concerned regulatory Copy of GMP certificate No. 06/2019-DRAP
authority of country of origin. (AD/607409-530) dated 11-01-2019 on the basis of
till 05-06-2023.
3. Documents for the procurement of API with Firm has submitted copy of clearance certificate (E-
approval from DRAP (in case of import). 2827420227964) dated 26-Sep-2022 specifying 1.0 Kg
of Potassium Clavulanate. The invoice is cleared by
DRAP, Lahore.
No.
1. First page of Form 5 is not submitted Submitted.
by the firm.
2. 1.6.5 Valid copy of GMP certificate of Amoxicillin Trihydrate:
both the drug substance Firm has submitted copy of GMP
manufacturer shall be submitted. certificate No. DC/A-
4/GMP/2022/2804 dated 07-09-2022
issued by Food Safety and Drugs
till 08-09-2023.
However, in the submitted dossier,
drug substance data from M/s
Pharmagen Limited was submitted.
Not submitted.
3. 3.2.S.4.1  Specifications of both the drug Submitted.
substances from drug product However, specifications from both
manufacturer shall be submitted. the drug substance and drug product
manufacturer are different from
each other in assay, water content
 Specification of the drug substance and sulphated ash.
provided by drug substance Firm has submitted specifications for
manufacturer has mentioned pH the drug substance i.e. mixture of
limit of 5.5 – 8 while the COA of potassium Clavulanate with Avicel
finished product manufacturer has (1:1) wherein the pH is 4.8-8 for the
mentioned 4.8-8. Clarification mixture. They further submitted that
shall be submitted. the same mixture is used as drug
substance instead of potassium
Clavulanate alone.
4. 3.2.S.4.2 Analytical procedures for both the Submitted.
drug substances from drug product
5. 3.2.S.4.3  Verification studies of the drug Submitted.
substance (amoxicillin trihydrate)
 Verification studies of the drug Submitted.
substance (Potassium Clavulanate)
6. 3.2.S.4.4  COA of the drug substance from Firm has submitted COA of the drug
both drug substance manufacturer substance Ampicillin trihydrate from
and finished product manufacturer drug substance manufacturer
with same batch numbers shall be instead of Amoxicillin trihydrate.
submitted. Firm has submitted that specifications
 Specification submitted by the are in compliance with the
drug substance manufacturer are specifications of the Potassium
all changed in the COA of the Clavulanate Diluted (Avicel or
finished product manufacturer. Syloid) 1:1.
Justification shall be submitted. They further submitted that since
potassium Clavulanate is not stable,
so, Avicel is added (in a ratio of 1:1 by
weight) by drug substance
manufacturer to make the final
product stable during the storage,
shipment and usage. They also
provided specifications for the same.
7. 3.2.S.5 Details/COA of the working Submitted.

standard used in the analysis of
Potassium Clavulanate shall be
submitted.
8. 3.2.S.7.3 All the tests in the stability data Firm has submitted that stability data
sheets are in contrast to the sheets of the drug substance is for the
specifications provided by the drug mixture of Potassium Clavulanate
substance manufacturer. Diluted.
Justification is required.
9. 3.2.P.5.2 Analytical procedures for the Submitted.
finished product shall be submitted. However, the submitted analytical
procedure is completely different
from BP monograph.
Concentration of the standard
solution for amoxicillin and
potassium Clavulanate are different
from BP. Furthermore, BP specifies
lithium Clavulanate as reference
standard while firm in their
analytical method has mentioned
potassium Clavulanate as reference
standard.
10. 3.2.P.8  Stability data sheets as per decision Not submitted.
of 293rd meeting of RB with
inclusion of API lot number shall
be submitted. Not submitted.
 Raw data sheets for calculation of
assay at each time point with
formula shall be submitted. Firm has submitted that in DRB 323rd
data of the firm (if any) shall be Firm has submitted that quantity of
submitted. potassium Clavulanate was calculated
 Justification regarding the to make three strengths. They further
quantity of drug substance i.e. submitted that calculation sheet is
Potassium Clavulanate shall be attached.
However, no calculation sheet is
submitted with respect to the attached with the file.
total quantity of the drug Firm has submitted copy of clearance
substance imported and total certificate (E-2827420227964) dated
quantity used in manufacturing 26-Sep-2022 specifying 1.0 Kg of
and testing of all the three Potassium Clavulanate. The invoice
strengths of Falamox is cleared by DRAP, Lahore.
suspension. As per record of the executed BMRs
of the trial batches with strength of
125mg/5ml, 37.23mg/5ml quantity of
potassium Clavulanate is used.
60ml of bottle is used in stability data.
37.23 x 12 = 446.76mg/bottle.
Total of 03 trial batches with batch
size of 500 each were manufactured.
1500 x 446.76 = 670,140mg or
670gm.
As per record of the executed BMRs

74.38 x 12 = 892.56mg/bottle.
1500 x 892.56 = 1,338,840mg or
1338gm.

67.83 x 12 = 813.96mg/bottle.
1500 x 813.96 = 1,220,940mg or
1220gm
Total of 1220 + 1338 + 670 = 3228gm
or 3.22kg.
 Justification shall be submitted for change in the submitted specifications i.e assay, water content
and sulphated ash between the specifications of drug substance manufacturer and drug product
manufacturer.
 Justification shall be submitted for submission of COA of the drug substance i.e Amoxicillin
trihydrate from drug substance manufacturer instead of Ampicillin trihydrate.
 Justification shall be submitted for Concentration of the standard solution for amoxicillin and
potassium Clavulanate in the analytical procedure as both are different from BP.
 Justification shall be submitted for using potassium Clavulanate as reference standard while BP has
mentioned lithium Clavulanate as reference standard.
 Stability data sheets as per decision of 293rd meeting of RB with inclusion of API lot number shall be
submitted.
 Raw data sheets for calculation of assay at each time point with formula shall be submitted.
 Justification shall be submitted regarding the total quantity of drug substance Potassium
Clavulanate imported i.e. 01kg vide clearance certificate (E-2827420227964) dated 26-Sep-2022 with
respect to the total quantity of the drug substance used in manufacturing and testing of all
the three strengths (09 trial batches) of Falamox suspension.
Sheikhupura.
☐ Importer
198/2022-DRAP (AD-9405944056-789) dated 17-11-
☐ Export sale
2023.
name
Potassium Clavulanate eq. Clavulanic Acid ……..
62.50mg.
specifications
Proposed Pack size 60ml & 90ml.
The status in reference regulatory Augmentin 250mg/62.50mg Oral Suspension, USFDA
For generic drugs (me-too status) Zamoclav suspension, Zafa Pharmaceutical, Reg.
No. 035386.
till 05-06-2023.
product.
substance.
substance.
months.
Batches: (00013/210/2009, 00013/211/2009,
00013/212/2009)
Batches: (NA-201106301, NA-201106301 & NA-
201106301)
250mg with B. No. SY2R, mfg. date 05-2022
Shanxi, China.
Batch No. T-001 T-002 T-003
No. of Batches 03
till 05-06-2023.
DRAP, Lahore.
No.
1. First page of Form 5 is not submitted Submitted.
by the firm.
2. 1.6.5 Valid copy of GMP certificate of Amoxicillin Trihydrate:
both the drug substance Firm has submitted copy of GMP
manufacturer shall be submitted. certificate No. DC/A-
4/GMP/2022/2804 dated 07-09-2022
issued by Food Safety and Drugs
till 08-09-2023.
However, in the submitted dossier,
drug substance data from M/s
Pharmagen Limited was submitted.
Not submitted.
3. 3.2.S.4.1  Specifications of both the drug Submitted.
substances from drug product However, specifications from both
manufacturer shall be submitted. the drug substance and drug product
manufacturer are different from
each other in assay, water content
 Specification of the drug substance and sulphated ash.
provided by drug substance Firm has submitted specifications for
manufacturer has mentioned pH the drug substance i.e. mixture of
limit of 5.5 – 8 while the COA of potassium Clavulanate with Avicel
finished product manufacturer has (1:1) wherein the pH is 4.8-8 for the
mentioned 4.8-8. Clarification mixture. They further submitted that
shall be submitted. the same mixture is used as drug
substance instead of potassium
Clavulanate alone.
4. 3.2.S.4.2 Analytical procedures for both the Submitted.
drug substances from drug product
5. 3.2.S.4.3  Verification studies of the drug Submitted.
substance (amoxicillin trihydrate)
 Verification studies of the drug Submitted.
substance (Potassium Clavulanate)
6. 3.2.S.4.4  COA of the drug substance from Firm has submitted COA of the drug
both drug substance manufacturer substance Ampicillin trihydrate from
and finished product manufacturer drug substance manufacturer
with same batch numbers shall be instead of Amoxicillin trihydrate.
submitted. Firm has submitted that specifications
 Specification submitted by the are in compliance with the
drug substance manufacturer are specifications of the Potassium
all changed in the COA of the Clavulanate Diluted (Avicel or
finished product manufacturer. Syloid) 1:1.
Justification shall be submitted. They further submitted that since
potassium Clavulanate is not stable,
so, Avicel is added (in a ratio of 1:1 by
weight) by drug substance
manufacturer to make the final
product stable during the storage,
shipment and usage. They also
provided specifications for the same.
7. 3.2.S.5 Details/COA of the working Submitted.

standard used in the analysis of
Potassium Clavulanate shall be
submitted.
8. 3.2.S.7.3 All the tests in the stability data Firm has submitted that stability data
sheets are in contrast to the sheets of the drug substance is for the
specifications provided by the drug mixture of Potassium Clavulanate
substance manufacturer. Diluted.
9. 3.2.P.5.2 Analytical procedures for the Submitted.
finished product shall be submitted. However, the submitted analytical
procedure is completely different
from BP monograph.
Concentration of the standard
solution for amoxicillin and
potassium Clavulanate are different
from BP. Furthermore, BP specifies
lithium Clavulanate as reference
standard while firm in their
analytical method has mentioned
potassium Clavulanate as reference
standard.
10. 3.2.P.8  Stability data sheets as per decision Not submitted.
rd
of 293 meeting of RB with
inclusion of API lot number shall
be submitted. Not submitted.
 Raw data sheets for calculation of
assay at each time point with
formula shall be submitted. Firm has submitted that in DRB 323rd
data of the firm (if any) shall be Firm has submitted that quantity of
submitted. potassium Clavulanate was calculated
 Justification regarding the to make three strengths. They further
quantity of drug substance i.e. submitted that calculation sheet is
Potassium Clavulanate shall be attached.
However, no calculation sheet is
submitted with respect to the attached with the file.
total quantity of the drug Firm has submitted copy of clearance
substance imported and total certificate (E-2827420227964) dated
quantity used in manufacturing 26-Sep-2022 specifying 1.0 Kg of
and testing of all the three Potassium Clavulanate. The invoice
strengths of Falamox is cleared by DRAP, Lahore.
suspension. As per record of the executed BMRs
37.23 x 12 = 446.76mg/bottle.
1500 x 446.76 = 670,140mg or
670gm.

74.38 x 12 = 892.56mg/bottle.
1500 x 892.56 = 1,338,840mg or
1338gm.

67.83 x 12 = 813.96mg/bottle.
1500 x 813.96 = 1,220,940mg or
1220gm
Total of 1220 + 1338 + 670 = 3228gm
or 3.22kg.
manufacturer.
submitted.
Sheikhupura.
☐ Importer
198/2022-DRAP (AD-9405944056-789) dated 17-11-
☐ Export sale
2023.
name
Potassium Clavulanate eq. Clavulanic Acid ….. 57mg.
specifications
Proposed Pack size 35ml & 70ml.
The status in reference regulatory Augmentin 400mg/57mg Oral Suspension, USFDA
For generic drugs (me-too status) Clav Forte 400mg + 57mg/5ml Dry Suspension,
Amrose Pharmaceuticals, Reg. No. 058102.
till 05-06-2023.
product.
substance.
substance.
months.
Batches: (00013/210/2009, 00013/211/2009,
00013/212/2009)
Batches: (NA-201106301, NA-201106301 & NA-
201106301)
400mg with B. No. RY4P, mfg. date 06-2022
Shanxi, China.
Batch No. T-001 T-002 T-003
No. of Batches 03
till 05-06-2023.
DRAP, Lahore.
No.
1. First page of Form 5 is not submitted by the Submitted.
firm.
2. 1.6.5 Valid copy of GMP certificate of both the Amoxicillin Trihydrate:
drug substance manufacturer shall be Firm has submitted copy of GMP certificate
submitted. No. DC/A-4/GMP/2022/2804 dated 07-09-
2022 issued by Food Safety and Drugs
Control Commissionerate (Drugs Control
Wing) Rajasthan, India valid till 08-09-2023.
However, in the submitted dossier, drug
substance data from M/s Pharmagen
Limited was submitted.
Not submitted.
3. 3.2.S.4.1  Specifications of both the drug substances Submitted.
from drug product manufacturer shall be However, specifications from both the drug
submitted. substance and drug product manufacturer
are different from each other in assay, water
content and sulphated ash.
 Specification of the drug substance Firm has submitted specifications for the
provided by drug substance manufacturer drug substance i.e. mixture of potassium
has mentioned pH limit of 5.5 – 8 while Clavulanate with Avicel (1:1) wherein the pH
the COA of finished product is 4.8-8 for the mixture. They further
manufacturer has mentioned 4.8-8. submitted that the same mixture is used as
Clarification shall be submitted. drug substance instead of potassium
Clavulanate alone.
4. 3.2.S.4.2 Analytical procedures for both the drug Submitted.
substances from drug product manufacturer
shall be submitted.
5. 3.2.S.4.3  Verification studies of the drug substance Submitted.
(amoxicillin trihydrate) performed by the
drug product manufacturer shall be
submitted.
 Verification studies of the drug substance Submitted.
(Potassium Clavulanate) performed by
submitted.
6. 3.2.S.4.4  COA of the drug substance from both Firm has submitted COA of the drug
drug substance manufacturer and finished substance Ampicillin trihydrate from drug
product manufacturer with same batch substance manufacturer instead of
numbers shall be submitted. Amoxicillin trihydrate.
 Specification submitted by the drug Firm has submitted that specifications are in
substance manufacturer are all changed in compliance with the specifications of the
the COA of the finished product Potassium Clavulanate Diluted (Avicel or
manufacturer. Justification shall be Syloid) 1:1.
submitted. They further submitted that since potassium
Clavulanate is not stable, so, Avicel is added
(in a ratio of 1:1 by weight) by drug substance
manufacturer to make the final product stable
during the storage, shipment and usage. They
also provided specifications for the same.
7. 3.2.S.5 Details/COA of the working standard used Submitted.

in the analysis of Potassium Clavulanate
shall be submitted.
8. 3.2.S.7.3 All the tests in the stability data sheets are Firm has submitted that stability data sheets
in contrast to the specifications provided by of the drug substance is for the mixture of
the drug substance manufacturer. Potassium Clavulanate Diluted.
9. 3.2.P.5.2 Analytical procedures for the finished Submitted.
product shall be submitted. However, the submitted analytical
procedure is completely different from BP
monograph.
Concentration of the standard solution for
amoxicillin and potassium Clavulanate are
different from BP. Furthermore, BP
specifies lithium Clavulanate as reference
standard while firm in their analytical
method has mentioned potassium
Clavulanate as reference standard.
10. 3.2.P.8  Stability data sheets as per decision of Not submitted.
293rd meeting of RB with inclusion of API
lot number shall be submitted.
 Raw data sheets for calculation of assay at Not submitted.
each time point with formula shall be
submitted.

rd
Reference of previous approval of Firm has submitted that in DRB 323
applications with stability study data of meeting their two products i.e. Faxcil 250mg
the firm (if any) shall be submitted. & 500.
 Justification regarding the quantity of Firm has submitted that quantity of
drug substance i.e. Potassium potassium Clavulanate was calculated to
Clavulanate shall be submitted with make three strengths. They further submitted
that calculation sheet is attached.
respect to the total quantity of the drug However, no calculation sheet is attached
substance imported and total quantity with the file.
used in manufacturing and testing of Firm has submitted copy of clearance
all the three strengths of Falamox certificate (E-2827420227964) dated 26-
suspension. Sep-2022 specifying 1.0 Kg of Potassium
Clavulanate. The invoice is cleared by
DRAP, Lahore.
As per record of the executed BMRs of the
trial batches with strength of 125mg/5ml,
37.23mg/5ml quantity of potassium
Clavulanate is used.
37.23 x 12 = 446.76mg/bottle.
Total of 03 trial batches with batch size of
500 each were manufactured.
1500 x 446.76 = 670,140mg or 670gm.

74.38 x 12 = 892.56mg/bottle.
1500 x 892.56 = 1,338,840mg or 1338gm.

67.83 x 12 = 813.96mg/bottle.
1500 x 813.96 = 1,220,940mg or 1220gm
Total of 1220 + 1338 + 670 = 3228gm or
3.22kg.
manufacturer.
submitted.
757. Name, address of Applicant / M/s Biogen Life Sciences, 8-KM Chakbeli Road, Rawat,
Marketing Authorization Holder Rawalpindi.
Name, address of Manufacturing site. M/s Biogen Life Sciences, 8-KM Chakbeli Road, Rawat,
Rawalpindi.
☐ Importer
GMP status of the firm Not submitted.
Evidence of approval of manufacturing Firm has submitted copy of section approval letter No. F. 1-
facility 2/2019-Lic dated 14/02/2020 wherein they have Ampoule
section SVP (General).
☐ Export sale
Details of fee submitted PKR 30,000/- vide slip No. 8013054618 Dated 15-02-2023
The proposed proprietary name / brand Biorolac 30mg/ml injection.
name
Strength / concentration of drug of Active Each 1ml ampoule contains:
Pharmaceutical ingredient (API) per unit Ketorolac Tromethamine .......... 30mg
Pharmacotherapeutic Group of (API) NSAID’s
Pharmaceutical form of applied drug Solution for Injection for IM/IV
Reference to Finished product USP Specifications.
specifications
Proposed Pack size Not submitted.
The status in reference regulatory Toradol 30mg/ml, USFDA Approved.
authorities
For generic drugs (me-too status) Toradol injection 30mg/ml, Martin Dow Marker Ltd., Reg.
No. 108584.
Name and address of API manufacturer. Saurav Chemical Limited., 370 industrial area Phase II
Panchkula, Haryana, India.
structure, general properties, solubility, physical form,
Module-III Drug Substance: Firm has submitted details of the drug substance related to
and its validation, batch analysis (KTM200008, mfg. date
drug substance.
Batch No. KTMB100005, KTMB100006 & KTMB100007.
Module-III Drug Product: Firm has submitted details of the drug product including its
Comparative Dissolution Profile product against the comparator product Toradol 30 mg/ml
by performing quality test of Identification, Particulate
matter, pH, Assay, Bacterial endotoxin test and Sterility test.
Manufacturer of API Saurav Chemical Limited., 370 industrial area Phase II Panchkula, Haryana,
India.
API Lot No. KTMD200008.
Description of Pack Transparent glass USP type-I Ampoules, further packed in bleach board pack
(Container closure system) containing 5 ampoules with ALU/PVC BLISTER and insert.
No. of Batches 03
1. Reference of previous approval of applications Firm has submitted that Biogen pharmaceutical is a
with stability study data of the firm (if any) new license facility hence no such inspection has been
conducted.
manufacturer issued by concerned regulatory Not submitted.
5. Compliance Record of HPLC software 21CFR Firm has submitted that their HPLC system are not 21
& audit trail reports on product testing CFR compliant.
6. Record of Digital data logger for temperature Not submitted.
Sr. Section Observations Reply by the firm
No.
1. First page of form 5F is not submitted. Submitted.
2. 1.3.4  Valid copy of DML for Biogen life Firm has submitted copy of DML No. 000911 in
sciences shall be submitted. the name of M/s Biogen Pharmaceuticals w.e.f.
13-02-2020 and also provided change of title
vide letter No. F. 1-2/2019-Lic. Dated 18-03-
2021 from M/s Biogen Pharmaceuticals to M/s
Biogen Life Sciences.
Not submitted.
 Valid copy of GMP certificate of the
applicant shall be submitted.
3. 1.3.5 Section approval letter has mentioned Firm has submitted that applied formulation is in
Ampoule section SVP (General) while the ampoule and they also have ampoule general
applied formulation is in vial. Justification section.
shall be submitted.
4. 1.5.4 Proposed pack size shall be submitted. 1x5’s
Blister contain 5 ampoule of 1 ml packed in unit
carton.
5. 2.3 Table for literature references with correct Revised table for literature references is
information regarding the drug product submitted without fee submission.
with applicable fee shall be submitted.
6. 1.6.5 Valid copy of GMP certificate of the drug Firm has submitted copy of GMP certificate No.
substance manufacturer issued by the Drugs (3) pb. 2021/3124 dated 25-06-2021
relevant/concerned regulatory authority issued by Food & Drugs Administration, Punjab
shall be submitted. in the name of M/s Saurav Chemical Limited.,
Derabassi-Barwala Road, Village Bhagwanpura,
Tehsil Derabassi, District Saibzada Ajit Singh
Nagar, (Punjab) valid till 25-06-2023.
Data submitted in the dossier has mentioned
Saurav Chemical Limited., 370 industrial area
Phase II Panchkula, Haryana, India while the
provided GMP certificate has mentioned some
other address.
Furthermore, validity of the certificate is till 25-
06-2023.
7. 3.2.S.4.1 Specifications of the drug substance by Submitted.
both the drug substance manufacturer and
finished product manufacturer shall be
submitted.
8. 3.2.S.4.2 Justification shall be submitted for the Firm has submitted that drug substance
assay test in the analytical procedures manufacturer used both the methods for analysis
provided by the drug substance of the drug substance. They also provided
manufacturer wherein assay test is by analytical procedure from the drug substance
potentiometry while USP has mentioned manufacturer by HPLC method.
HPLC method.
9. 3.2.S.4.3 Verification of analytical procedures of Submitted.
the drug substance performed by the drug
product manufacturer shall be submitted.
10. 3.2.S.4.4  COA’s from both the drug substance and Firm has submitted copies of COAs from both
drug product manufacturer with same the drug substance manufacturer and finished
batch number shall be submitted. product manufacturer with COA No.
KTM200008, mfg. date 01-2020.
 COA of the drug substance from drug Firm has submitted they perform all the
product manufacturer has only one identification test on drug substance. Tests are
identification test while the COA of the also evident from the newly submitted COA.
finished product manufacturer and USP
monograph has three different test.
Justification shall be submitted.
11. 3.2.S.7.3  Complete real time stability of all the Firm has submitted real time stability data for
three batches of the drug substance shall three batches the drug substance for 48 months.
be submitted.
 Justification shall be submitted for not Firm has submitted that due to Aseptic filling of
conducting most of the test in the Biorolac 30mg/ml solution (Ketorolac
stability of the drug substance i.e. Tromethamine) the Raw material (Ketorolac
Sterility, bacterial endotoxin pH etc. Tromethamine) is non sterile powder. That why
drug substance manufacturer does not perform
Bacterial Endotoxin Test &Sterility test. Other
test like pH ,LOD Melting Point, Assay
Impurities performed by drug substance
manufacturer which are mentioned in the
stability summery sheet.
12. 3.2.P.2.2 Details of the comparator product Product Name: Toradol 30mg/ml Injection
including its manufacturer, batch No. and Registration Number: 108584
manufacturing date etc. shall be submitted. Batch No: 25003
Mfg. Date:06/2022
Exp. Date:05/2024
Manufactured by :Martin Dow Marker LTD
13. 3.2.P.3.3 Scientific justification shall be submitted Firm has submitted that the Finished Product
for not performing the terminal was Terminally sterilized as recorded on BMR
sterilization of the finished product. page No. 12 Which could not be mentioned
here.
14. 3.2.P.5.2 Complete analytical procedures for all the Submitted.
tests shall be submitted.
15. 3.2.P.5.6 This section has mentioned manufacturer Specification of Biorolac Injection is USP specs
specifications. Justification shall be however, due to typographical mistake, instead
submitted. of USP Specifications Manufacturer
specifications was mentioned.
16. 3.2.P.8  Reference of previous approval of Not applicable.
the firm (if any) shall be submitted.
 Documents for the procurement of API Firm has submitted commercial invoice No.
with approval from DRAP (in case of SCL/2020-21/138 dated 26-09-2020 mentioning
import) shall be submitted. 50gm of ketorolac Tromethamine USP with
 Record of Digital data logger for batch no. KTM200008, mfg. date of 01-01-2020.
temperature and humidity monitoring of However, invoice is not attested by DRAP.
stability chambers (real time and Submitted.
accelerated) shall be submitted.
 Compliance Record of HPLC software Submitted.
testing shall be submitted.
 Valid copy of GMP certificate of the applicant shall be submitted.
 Clarification regarding the drug substance manufacturer shall be submitted as the submitted GMP
certificate has different address than the information submitted in 3.2.S.
 Valid copy of the GMP certificate of the drug substance manufacturer shall be submitted.
 Scientific justification shall be submitted for performing the terminal sterilization of the finished
product with reference to innovator drug product literature.
 Documents for the procurement of API with approval from DRAP (in case of import) shall be
submitted.
 Submission of 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 07-05-2021 shall be submitted.
B. Application of locally manufactured deferred drugs on Form 5F.

758. Name, address of Applicant / Marketing M/s Wimits Pharmaceuticals (Pvt.) Ltd.,
Authorization Holder 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
Dy. No. and date of submission Dy. No. 34507; dated 29/11/2022.
Details of fee submitted PKR 30,000/-: vide slip No.19942923 dated
25/11/2022.
The proposed proprietary name / brand name Pime-4 500mg Injection.
Pharmaceutical ingredient (API) per unit Cefepime HCl with L-Arginine eq. to
Cefepime ….500mg
Pharmaceutical form of applied drug Dry powder injection.
Pharmacotherapeutic Group of (API) 01DE Fourth-generation cephalosporin
Reference to Finished product specifications USP specifications.
Proposed Pack size 1’s.
The status in reference regulatory authorities MAXIPIME 500mg & 1gm (Cefepime
hydrochloride) for injection, USFDA
Approved.
For generic drugs (me-too status) CefStar for injection 500mg IV/IM, Barret
Hodgson Pakistan (Pvt.) Ltd., Registration No:
030953.
GMP status of the Finished product GMP Certificate No.70/2021-
manufacturer DRAP(FID/2061717-540) Dated 08-09-21
Evidence of section approval. Dry Powder Injection (Cephalosporin) - New
section vide No.F.1-10/2012-Lic dated 07-06-
2022 is approved.
Name and address of API manufacturer. M/s Kopran Research Laboratories Limited,
K4/4, Additional MIDC, At & Post Birwadi,
Taluka Mahad, District Raigad - 402 302
Maharashtra, India.
solubility, physical form, manufacturers,
submitted.
Module III (Drug Substance) Official monograph of Cefepime HCl and L-
Arginine is present in USP. Firm has submitted
detail of the drug substance regarding its
controls, tests for impurity, specifications,
analysis (CEIV/B2201004, mfg. date 11-2022)
Stability studies (Drug substance.) Firm has submitted both real time and
accelerated stability study data for the drug
substance for three batches.
Real time: 30°C ± 2°C /65% ± 5%RH for 36
months
months
Batches:
(CEIV/B1203011, CEIV/B1203012,
CEIV/B1203013)
Module-III (Drug Product): The firm has submitted detail of the drug
product including its description &
composition, Pharmaceutical equivalence,
process and controls, process validation
protocol, specifications, analytical procedure
drug product.
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence is established
dissolution profile against the brand leader that is Cefstar 500mg
IV/IM injection by performing quality tests
(Identification, Average weight content &
Assay).
specificity.
Manufacturer of API M/s Kopran Research Laboratories Limited,
K4/4, Additional MIDC, At & Post Birwadi, Taluka
Mahad, District Raigad - 402 302 Maharashtra, India.
API Lot No. CEIV/B2201004.
Description of Pack 1x10ml vial containing Cefepime HCl with L-Arginine
(Container closure system) with reconstituent Diluent (WFI).
Batch No. TCH001 TCH002 TCH001
No. of Batches 03
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.
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP certificate No.
manufacturer issued by concerned regulatory New-WHO-
authority of country of origin. GMP/Cert/KD/89275/2020/11/33788 dated 20-
10-2020 issued on the basis of inspection
conducted on 06-03-2020 valid till 19-10-2023.
approval from DRAP (in case of import). No. E-897164883689 dated 19-04-2022 for
50Kg of Cefepime HCl and L-Arginine sterile
USP having Batch No. CEIV/B2201004 with
manufacturing date of 01-11-2021 issued in
name of M/s Medisave attested by AD I&E
DRAP, Lahore.
Firm has also submitted copy of loan letter from
M/s Medisave Pharmaceutical for 05kg.
chromatograms, Submitted
etc.
Submitted
Remarks by the Evaluator:
No.
1. 1.3.4 Latest GMP certificate/last Firm has submitted copy of GMP
inspection report conducted within certificate No. 70/2021-DRAP
last three years for the Finished (FID/2061717-540) dated 08-09-2021
Product manufacturer shall be issued on the basis of inspection
submitted. conducted on 08-09-2021.
2. 2.3.R Table for literature references shall Not submitted.
be revised with inclusion of status
of both drug substance and finished
product in pharmacopoeia with
applicable fee.
3. 3.2.S.4.1 Drug Substance manufacturer has Firm has submitted that it was
mentioned L-arginine quantity (on typographic error and also submitted
as is basis) between 34% - 44% corrected specification and corrected
while FPP has mentioned 37.1% - COA for the drug substance.
44%. Clarify. However, fee applicable to pre-
registration variation is not submitted.
4. 3.2.S.4.2 Calculation formula for assay of Submitted.
drug substance shall be provided.
5. 3.2.S.4.4  Justification shall be submitted Firm has only submitted COA of the
regarding the COA of the drug drug substance from supplier.
substance provided by the drug However, initially submitted
product manufacturer as assay specification provided by the drug
of Cefepime base on as is basis substance manufacturer has assay limit
in the same is 50.19% while the of Cefepime on as is basis of NLT
specification provided by the 50.5% while the COA of the finished
drug substance manufacturer product manufacturer has assay of
has assay limit of Cefepime on Cefepime on as is basis of 50.19 which
as is basis of NLT 50.5%. is out of specifications.
 COA of the drug substance by Firm has submitted that it was typo
the drug product manufacturer error and they also provided corrected
has manufacturing date of 11- COA.
2022 while that of the drug
substance manufacturer has
manufacturing date of 11-2021.
Clarify.
6. 3.2.P.2.2  Justification shall be submitted Firm has submitted that due to easy
for not performing availability of market sample Cefstar
Pharmaceutical Equivalence injection was used in PE.
against the innovator product. CefStar 500mg Injection, Batch No.
 Details of the reference product C7100, Mfg. date 03-2021 is submitted.
used in the Pharmaceutical
Equivalence shall be submitted. Firm has submitted revised results for
 pH test is not performed. pharmaceutical equivalence wherein
they have added pH test.
Not submitted.
for not performing most of the
quality test applicable on
7. 3.2.P.8 In use stability data shall be Firm has submitted that its ready to use
submitted. injection.
th
Decision of 326 meeting of Registration Board: Deferred for following:
 Revised table for literature references with inclusion of status of the both drug substance and finished
product in different pharmacopoeias shall be submitted.
 Justification shall be submitted for use of out of specifications drug substance in the trial batches.
 Submission of Pharmaceutical Equivalence against the innovator product.
 Submission of Rs. 7,500/- fee for revision of specifications as per notification No.F.7-11/2021-B&A/DRAP
dated 07-05-2021.
Reply by the firm:
S. Reason for deferment Reply submitted by the firm
No.
1. Revised table for literature references with inclusion Firm has submitted revised table for literature
of status of the both drug substance and finished references with correct information.
product in different pharmacopoeias shall be
submitted.
2. Justification shall be submitted for use of out of Firm has submitted that it was a typo error and
specifications drug substance in the trial batches. they also submitted raw data sheets for the new
calculation wherein the assay on as is basis is
50.60.
However, they also submitted COA for the drug
substance wherein still same value of 50.19% is
mentioned.
3. Submission of Pharmaceutical Equivalence against Firm has submitted pharmaceutical equillance
the innovator product. with Maxipime 500mg injection by performing
quality tests of Description, Identification,
clarity of solution, pH, water content, Average
weight content, uniformity of dosage units, BET,
Sterility & Assay.
However, no details of the comparator product
such as manufacturer, batch number,
manufacturing date expiry date etc. are not
mentioned.
4. Submission of Rs. 7,500/- fee for revision of Firm has submitted fee of 7500/- vide slip No.
specifications as per notification No.F.7-11/2021- 81101392 dated 13-06-2023.
Decision: Approved.
759. Name, address of Applicant / Marketing M/s Wimits Pharmaceuticals (Pvt.) Ltd., Plot
Authorization Holder #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
25/11/2022.
The proposed proprietary name / brand name Pime-4 1gm Injection.
Pharmaceuti cal ingredient (API) per unit Cefepime HCl with L-Arginine eq. to Cefepime
………………………………..……….1000mg
Pharmaceutical form of applied drug Dry powder injection.
Pharmacotherapeutic Group of (API) 01DE Fourth-generation cephalosporin
Approved.
030954.
GMP status of the Finished product GMP Certificate No.70/2021-
manufacturer DRAP(FID/2061717-540) Dated 08-09-21
Evidence of section approval. Dry Powder Injection (Cephalosporin) - New
section vide No.F.1-10/2012-Lic dated 07-06-
2022 is approved.
Name and address of API manufacturer. M/s Kopran Research Laboratories Limited,
K4/4, Additional MIDC, At & Post Birwadi,
Taluka Mahad, District Raigad - 402 302
Maharashtra, India.
submitted.
Module III (Drug Substance) Official monograph of Cefepime HCl and L-
Arginine is present in USP. Firm has submitted
detail of the drug substance regarding its
controls, tests for impurity, specifications,
analysis (CEIV/B2201004, mfg. date 11-2022)
months
months
Batches:
(CEIV/B1203011, CEIV/B1203012,
CEIV/B1203013)
drug product.
dissolution profile against the brand leader that is Cefstar 1000mg
IV/IM injection by performing quality tests
(Identification, Average weight content &
Assay).
specificity.
Manufacturer of API M/s Kopran Research Laboratories Limited,
K4/4, Additional MIDC, At & Post Birwadi, Taluka
Mahad, District Raigad - 402 302 Maharashtra, India.
API Lot No. CEIV/B2201004.
Description of Pack 1x10ml vial containing Cefepime HCl with L-Arginine
(Container closure system) with reconstituent Diluent (WFI).
Batch No. TCP001 TCP002 TCP001
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP certificate No.
manufacturer issued by concerned regulatory New-WHO-
authority of country of origin. GMP/Cert/KD/89275/2020/11/33788 dated 20-
10-2020 issued on the basis of inspection
conducted on 06-03-2020 valid till 19-10-2023.
approval from DRAP (in case of import). No. E-897164883689 dated 19-04-2022 for
50Kg of Cefepime HCl and L-Arginine sterile
USP having Batch No. CEIV/B2201004 with
manufacturing date of 01-11-2021 issued in
name of M/s Medisave attested by AD I&E
DRAP, Lahore.
Firm has also submitted copy of loan letter from
M/s Medisave Pharmaceutical for 05kg.
chromatograms, Submitted
etc.
Submitted
No.
1. 1.3.4 Latest GMP certificate/last Firm has submitted copy of GMP
inspection report conducted within certificate No. 70/2021-DRAP
last three years for the Finished (FID/2061717-540) dated 08-09-2021
Product manufacturer shall be issued on the basis of inspection
submitted. conducted on 08-09-2021.
2. 2.3.R Table for literature references shall Not submitted.
be revised with inclusion of status
of both drug substance and finished
product in pharmacopoeia with
applicable fee.
3. 3.2.S.4.1 Drug Substance manufacturer has Firm has submitted that it was
mentioned L-arginine quantity (on typographic error and also submitted
as is basis) between 34% - 44% corrected specification and corrected
while FPP has mentioned 37.1% - COA for the drug substance.
44%. Clarify. However, fee applicable to pre-
registration variation is not submitted.
4. 3.2.S.4.2 Calculation formula for assay of Submitted.
drug substance shall be provided.
5. 3.2.S.4.4  Justification shall be submitted Firm has only submitted COA of the
regarding the COA of the drug drug substance from supplier.
substance provided by the drug However, initially submitted
product manufacturer as assay specification provided by the drug
of Cefepime base on as is basis substance manufacturer has assay limit
in the same is 50.19% while the of Cefepime on as is basis of NLT
specification provided by the 50.5% while the COA of the finished
drug substance manufacturer product manufacturer has assay of
has assay limit of Cefepime on Cefepime on as is basis of 50.19 which
as is basis of NLT 50.5%. is out of specifications.
 COA of the drug substance by Firm has submitted that it was typo
the drug product manufacturer error and they also provided corrected
has manufacturing date of 11- COA.
2022 while that of the drug
substance manufacturer has
manufacturing date of 11-2021.
Clarify.
6. 3.2.P.2.2  Justification shall be submitted Firm has submitted that due to easy
for not performing availability of market sample Cefstar
Pharmaceutical Equivalence injection was used in PE.
against the innovator product. CefStar 500mg Injection, Batch No.
 Details of the reference product C7100, Mfg. date 03-2021 is
used in the Pharmaceutical submitted.
Equivalence shall be submitted. Firm has submitted revised results for
 pH test is not performed. pharmaceutical equivalence wherein
they have added pH test.
Not submitted.

for not performing most of the
quality test applicable on
7. 3.2.P.8 In use stability data shall be Firm has submitted that its ready to use
submitted. injection.
Decision of 326th meeting of Registration Board: Deferred for following:
 Revised table for literature references with inclusion of status of the both drug substance and finished
product in different pharmacopoeias shall be submitted.
 Justification shall be submitted for use of out of specifications drug substance in the trial batches.
 Submission of Pharmaceutical Equivalence against the innovator product.
 Submission of Rs. 7,500/- fee for revision of specifications as per notification No.F.7-11/2021-B&A/DRAP
dated 07-05-2021.
Reply by the firm:
S. Reason for deferment Reply submitted by the firm
No.
1. Revised table for literature references with Firm has submitted revised table for
inclusion of status of the both drug substance literature references with correct
and finished product in different information.
pharmacopoeias shall be submitted.
2. Justification shall be submitted for use of out Firm has submitted that it was a typo
of specifications drug substance in the trial error and they also submitted raw data
batches. sheets for the new calculation wherein
the assay on as is basis is 50.60.
However, they also submitted COA for
the drug substance wherein still same
value of 50.19% is mentioned.
3. Submission of Pharmaceutical Equivalence Firm has submitted pharmaceutical
against the innovator product. equillance with Maxipime 1000mg
injection by performing quality tests of
Description, Identification, clarity of
solution, pH, water content, Average
weight content, uniformity of dosage
units, BET, Sterility & Assay.
However, no details of the comparator
product such as manufacturer, batch
number, manufacturing date expiry
date etc. are not mentioned.
4. Submission of Rs. 7,500/- fee for revision of Firm has submitted fee of 7500/- vide
specifications as per notification No.F.7- slip No. 12428508 dated 13-06-2023.
11/2021-B&A/DRAP dated 07-05-2021.
Decision: Approved.
760. Name, address of Applicant / Marketing M/s Invictus Pharmaceuticals,
Authorization Holder Plot No. 21 & 26, Street No. NS-2, RCCI,
Industrial Estate, Rawat.
Name, address of Manufacturing site. M/s Invictus Pharmaceuticals,
Plot No. 21 & 26, Street No. NS-2, RCCI,
☐ Importer
giver)
☐ Export sale
01/08/2022.
The proposed proprietary name / brand name Invipam 500mg Injection IM/IV.
Pharmaceutical ingredient (API) per unit Cefepime HCl with L-Arginine
………………………………..……….500mg
Pharmaceutical form of applied drug Sterile Powder for injection.
Pharmacotherapeutic Group of (API) Fourth-generation cephalosporin.
(J01DE)
Proposed unit price As per policy.
Approved.
030953.
GMP status of the Finished product Last inspection report conducted on 31-08-2022
manufacturer is submitted wherein the firm was working at
good level of GMP.
Evidence of section approval. Dry Powder Injection (Cephalosporin) section
vide No.F.1-37/2016-Lic (Vol-I) dated 18-02-
2022 is approved.
Name and address of API manufacturer. M/s Shandong Luoxin Pharmaceutical Group
Hengxin Pharmaceutical Co., Ltd., West Side
of yanbin Road, Feixian Economic
Development Zone, Shandong, China.
Firm has submitted copy of manufacturing
license No. Lu 20150511 valid till 26-10-
2015.
(Raw materials, Sterile raw materials)
solubility, manufacturers, description of
specifications, analytical procedures, batch
and stability studies of drug substance and drug
Module III (Drug Substance) Firm has submitted detail of the drug substance
regarding its nomenclature, structure, general
analysis (11C0742107001, Mfg. date 12-07-
2021) and justification of specification,
months
months
Batches: (11C0741702001, 11C0741702002 &
11C0741702003)
justification of specification, reference
dissolution profile against the brand leader that is Maxipime
500mg IV/IM injection batch No. Y83J, mfg.
date 01-2021 manufactured by GSK, Pakistan
by performing quality tests (Identification,
water content, pH, bacterial endotoxin, sterility
& Assay).
specificity.
Manufacturer of API M/s Shandong Luoxin Pharmaceutical Group
Hengxin Pharmaceutical Co., Ltd., West Side of
yanbin Road, Feixian Economic Development Zone,
Shandong, China.
API Lot No. 11C0742107001.
Description of Pack Transparent Type II glass vial filled with powder,
(Container closure system) closed with rubber stopper and flip-off seal.
Batch No. TDI001 TDI002 TDI003
No. of Batches 03
14. Approval of API/ DML/GMP certificate of API Firm has submitted copy of manufacturing
manufacturer issued by concerned regulatory license No. Lu 20150511 valid till 26-10-2025.
authority of country of origin. (Raw materials, Sterile raw materials)

Submitted
Not Submitted
and humidity monitoring of stability chambers Not Submitted
No.
1. 1.5.2 or Label claim of the applied formulation
3.2.P.5.1 shall be revised as per reference product
with submission of full fee.
2. 1.5.5 Pharmacotherapeutic group shall be
changed from third generation
th
cephalosporin to 4 generation
cephalosporin.
3. 2.3. Table for literature references shall be
revised with inclusion of status of both
drug substance and finished product in
pharmacopoeia.
4. 3.2.S.4.1 Specifications of the drug substance by the
drug substance manufacturer shall be
submitted.
5. 3.2.S.4.2 Analytical procedures for the drug
substance used by the drug product
6. 3.2.S.4.3 Verification studies of the drug substance
7. 3.2.S.7  Specifications of the drug substance
provided by the drug substance
manufacturer are different from the
specification of the drug substance in the
stability data sheets. Justification shall be
submitted.
 Specifications of the drug substance has
mentioned “Contains NLT 90% and
NMT 115% of Cefepime HCl calculated
on anhydrous and Arginine free basis”
while the stability data sheets for the
drug substance has mentioned “NLT
83% of Cefepime calculated on
anhydrous and Arginine free basis”.
8. 3.2.P.5.1 Specifications provided by the finished
product manufacturer for the drug product
is for Lidocaine HCl instead of Cefepime
HCl with L arginine. Clarification shall be
submitted.
9. 3.2.P.5.2 Analytical procedures provided by the
finished product manufacturer for the drug
product is for Lidocaine HCl instead of
Cefepime HCl with L arginine.
Signed analytical procedures for the drug
10. 3.2.P.8  Identification test, water content tests
are not performed in the stability studies
of the drug product.
 Stability data sheets shall be as per
decision of 293rd meeting of
Registration Board with inclusion of
API lot number, date of initiation of
stability studies and total batch size.
 Documents for the procurement of API
with approval from DRAP shall be
submitted.
the firm shall be submitted.
Decision of 327th meeting of Registration Board:
Registration Board deferred the case for submission of reply to the above cited shortcomings.
Reply submitted by the firm:

No.
1. 1.5.2 or Label claim of the applied formulation Firm has submitted revised label claim as
3.2.P.5.1 shall be revised as per reference product under;
with submission of full fee. Each Vial contains:
Cefepime HCl with L-Arginine eq. to
Cefepime ………….500mg.
Firm has submitted Fee of 7500/- vide slip
No. 92213403304 dated 29-05-2023 and
differential fee of 22500/- vide slip No.
97100344 dated 13-07-2023.
2. 1.5.5 Pharmacotherapeutic group shall be Firm has submitted that it was a typographic
changed from third generation error and revised Pharmacotherapeutic group
cephalosporin to 4th generation from third generation cephalosporin to 4 th
cephalosporin. generation cephalosporin.
3. 2.3. Table for literature references shall be Firm has submitted revised table for literature
revised with inclusion of status of both references with correct information regarding
drug substance and finished product in both the drug substance and finished product.
pharmacopoeia.
4. 3.2.S.4.1 Specifications of the drug substance by the Submitted.
submitted.
7. 3.2.S.7  Specifications of the drug substance Firm has submitted new stability data sheets
provided by the drug substance for the same batches of the drug substance
manufacturer are different from the with specifications provided by the drug
specification of the drug substance in the substance manufacturer.
submitted.
 Specifications of the drug substance has Firm has submitted new stability data sheets
mentioned “Contains NLT 90% and for the same batches of the drug substance
NMT 115% of Cefepime HCl calculated with assay specifications of 34% to 42% of
on anhydrous and Arginine free basis” Arginine and NLT 90% NMT 115% of
while the stability data sheets for the Cefepime calculated on anhydrous and
drug substance has mentioned “NLT arginine free basis.
8. 3.2.P.5.1 Specifications provided by the finished Firm has submitted USP specifications for the
product manufacturer for the drug product drug product.
is for Lidocaine HCl instead of Cefepime
HCl with L arginine. Clarification shall be
submitted.
9. 3.2.P.5.2 Analytical procedures provided by the Submitted.
10. 3.2.P.8  Identification test, water content tests Firm has submitted revised stability data
are not performed in the stability studies sheets for all the three trial batches as per
of the drug product. decision of 293rd meeting of Registration
 Stability data sheets shall be as per Board with inclusion of API lot number, date
decision of 293rd meeting of of initiation of stability studies and total batch
Registration Board with inclusion of size. They also included Identification test,
API lot number, date of initiation of water content tests in the revised stability data
stability studies and total batch size. sheets.
API lot No. 11C0742107001.
Trial batch size is 500 vials each.
15-11-2021 is the initiation date of stability
studies.
Firm has submitted commercial invoice No.
 Documents for the procurement of API CI-HXIP201910PK-074 dated 10-09-2021
with approval from DRAP shall be mentioning 10kg quantity of Cefepime HCL
submitted. L-Arginine with batch number
11C0742107001, Mfg. date 12-07-2021
attested by Assistant Director I&E, DRAP,
Islamabad dated 22-10-2021.
Submitted.

Each Vial contains:
Cefepime HCl with L-Arginine eq. to Cefepime ………….500mg.
☐ Importer
giver)
☐ Export sale
01/08/2022.
………………………………..……….1000mg
(J01DE)
The status in reference regulatory authorities MAXIPIME 500mg, 1gm & 2gm (Cefepime
Approved.
030954.
good level of GMP.
2022 is approved.
2015.
months
months
Batches: (11C0741702001, 11C0741702002 &
11C0741702003)
dissolution profile against the brand leader that is Maxipime
1000mg IV/IM injection batch No. Y83J, mfg.
date 01-2021 manufactured by GSK, Pakistan
by performing quality tests (Identification,
water content, pH, sterility, bacterial endotoxin
& Assay).
specificity.
Shandong, China.
Batch No. TDI001 TDI002 TCH003
No. of Batches 03
Submitted
chromatograms,
Not Submitted
No.
1. 1.5.2 or Label claim of the applied formulation shall
3.2.P.5.1 be revised as per reference product with
submission of full fee.
2. 1.5.5 Pharmacotherapeutic group shall be changed
from third generation cephalosporin to 4 th
generation cephalosporin.
revised with inclusion of status of both drug
substance and finished product in
pharmacopoeia.
4. 3.2.S.4.1 Specifications of the drug substance by the
submitted.
5. 3.2.S.4.2 Analytical procedures for the drug substance
used by the drug product manufacturer shall
be submitted.
6. 3.2.S.4.3 Verification studies of the drug substance
shall be submitted.
specification of the drug substance in the
submitted.
 Specifications of the drug substance has
mentioned “Contains NLT 90% and NMT
115% of Cefepime HCl calculated on
anhydrous and Arginine free basis” while
the stability data sheets for the drug
substance has mentioned “NLT 83% of
Cefepime calculated on anhydrous and
Arginine free basis”. Justification shall be
submitted.
8. 3.2.P.5.1 Specifications provided by the finished
product manufacturer for the drug product is
for Lidocaine HCl instead of Cefepime HCl
with L arginine. Clarification shall be
submitted.
9. 3.2.P.5.2 Analytical procedures provided by the
10. 3.2.P.8  Identification test, water content tests are
not performed in the stability studies of
the drug product.
decision of 293rd meeting of Registration
Board with inclusion of API lot number,
date of initiation of stability studies and
total batch size.
 Documents for the procurement of API
with approval from DRAP shall be
submitted.

No.
1. 1.5.2 or Label claim of the applied Firm has submitted revised label
3.2.P.5.1 formulation shall be revised as per claim as under;
reference product with submission of Each Vial contains:
full fee. Cefepime HCl with L-Arginine eq.
to Cefepime ………….1000mg.
Firm has submitted Fee of 7500/-
vide slip No. 8750368472 dated 29-
05-2023 and differential fee of
22500/- vide slip No. 7672810381
dated 13-07-2023.
2. 1.5.5 Pharmacotherapeutic group shall be Firm has submitted that it was a
changed from third generation typographic error and revised
cephalosporin to 4th generation Pharmacotherapeutic group from
cephalosporin. third generation cephalosporin to 4th
generation cephalosporin.
3. 2.3. Table for literature references shall be Firm has submitted revised table for
revised with inclusion of status of literature references with correct
both drug substance and finished information regarding both the drug
product in pharmacopoeia. substance and finished product.
4. 3.2.S.4.1 Specifications of the drug substance Submitted.
by the drug substance manufacturer
shall be submitted.
6. 3.2.S.4.3 Verification studies of the drug Submitted.
substance performed by the drug
product manufacturer shall be
submitted.
7. 3.2.S.7  Specifications of the drug substance Firm has submitted new stability data
provided by the drug substance sheets for the same batches of the
manufacturer are different from the drug substance with specifications
specification of the drug substance provided by the drug substance
in the stability data sheets. manufacturer.
 Specifications of the drug substance Firm has submitted new stability data
has mentioned “Contains NLT 90% sheets for the same batches of the
and NMT 115% of Cefepime HCl drug substance with assay
calculated on anhydrous and specifications of 34% to 42% of
Arginine free basis” while the Arginine and NLT 90% NMT 115%
stability data sheets for the drug of Cefepime calculated on anhydrous
substance has mentioned “NLT and arginine free basis.
8. 3.2.P.5.1 Specifications provided by the Firm has submitted USP
finished product manufacturer for the specifications for the drug product.
drug product is for Lidocaine HCl
instead of Cefepime HCl with L
arginine. Clarification shall be
submitted.
9. 3.2.P.5.2 Analytical procedures provided by Submitted.
the finished product manufacturer for
the drug product is for Lidocaine HCl
instead of Cefepime HCl with L
arginine.
Signed analytical procedures for the
drug product shall be submitted.
10. 3.2.P.8  Identification test, water content Firm has submitted revised stability
tests are not performed in the data sheets for all the three trial
stability studies of the drug batches as per decision of 293rd
product. meeting of Registration Board with
 Stability data sheets shall be as per inclusion of API lot number, date of
decision of 293rd meeting of initiation of stability studies and total
Registration Board with inclusion batch size. They also included
of API lot number, date of Identification test, water content tests
initiation of stability studies and in the revised stability data sheets.
total batch size. API lot No. 11C0742107001.
11-11-2021 is the initiation date of
stability studies.
Firm has submitted commercial
invoice No. CI-HXIP201910PK-074
 Documents for the procurement of dated 10-09-2021 mentioning 10kg
API with approval from DRAP quantity of Cefepime HCL L-
shall be submitted. Arginine with batch number
11C0742107001, Mfg. date 12-07-
2021 attested by Assistant Director
I&E, DRAP, Islamabad dated 22-10-
2021.
 Reference of previous approval of Submitted.
applications with stability study
data of the firm shall be submitted.
software 21CFR & audit trail
submitted.
Each Vial contains:
Cefepime HCl with L-Arginine eq. to Cefepime ………….1000mg.
☐ Importer
giver)
☐ Export sale
04/08/2022.
………………………………..……….2000mg
(J01DE)
The status in reference regulatory authorities MAXIPIME 500mg, 1gm & 2gm (Cefepime
Approved.
089284.
good level of GMP.
2022 is approved.
2015.
months
months
Batches: (11C0741702001, 11C0741702002 &
11C0741702003)
dissolution profile against the brand leader that is Maxum 2000mg
injection batch No. 218006, mfg. date 02-2021
manufactured by M/s Highnoon pharma by
performing quality tests (Identification, water
content, pH, sterility, bacterial endotoxin &
Assay).
specificity.
Shandong, China.
API Lot No. 11C0742107001.
Batch No. TDI001 TDI002 TCH003
No. of Batches 03

Submitted
chromatograms,
Not Submitted
No.
1. 1.5.2 or Label claim of the applied formulation
3.2.P.5.1 shall be revised as per reference
product with submission of full fee.
2. 1.5.5 Pharmacotherapeutic group shall be
changed from third generation
cephalosporin to 4th generation
cephalosporin.
revised with inclusion of status of both
drug substance and finished product in
pharmacopoeia.
4. 3.2.S.4.1 Specifications of the drug substance by
the drug substance manufacturer shall
be submitted.
5. 3.2.S.4.2 Analytical procedures for the drug
6. 3.2.S.4.3 Verification studies of the drug
substance performed by the drug
product manufacturer shall be
submitted.
specification of the drug substance in
the stability data sheets. Justification
shall be submitted.
 Specifications of the drug substance
has mentioned “Contains NLT 90%
and NMT 115% of Cefepime HCl
calculated on anhydrous and Arginine
free basis” while the stability data
sheets for the drug substance has
mentioned “NLT 83% of Cefepime
calculated on anhydrous and Arginine
free basis”. Justification shall be
submitted.
8. 3.2.P.2.2 Justification shall be submitted for not
performing PE against the innovator
product.
9. 3.2.P.5.2 Signed analytical procedures for the
drug product shall be submitted.
10. 3.2.P.8  Identification test, water content
tests are not performed in the
stability studies of the drug product.
decision of 293rd meeting of
Registration Board with inclusion of
API lot number, date of initiation of
stability studies and total batch size.
 Documents for the procurement of

API with approval from DRAP shall
be submitted.
of the firm shall be submitted.
software 21CFR & audit trail reports
on product testing shall be
submitted.

No.
1. 1.5.2 or Label claim of the applied formulation shall Firm has submitted revised label claim as
3.2.P.5.1 be revised as per reference product with under;
submission of full fee. Each Vial contains:
Cefepime HCl with L-Arginine eq. to
Cefepime ………….2000mg.
Firm has submitted Fee of 7500/- vide slip
No. 166008087933 dated 29-05-2023 and
differential fee of 22500/- vide slip No.
26857018807 dated 13-07-2023.
2. 1.5.5 Pharmacotherapeutic group shall be changed Firm has submitted that it was a typographic
from third generation cephalosporin to 4 th error and revised Pharmacotherapeutic
generation cephalosporin. group from third generation cephalosporin
to 4th generation cephalosporin.
3. 2.3. Table for literature references shall be Firm has submitted revised table for
revised with inclusion of status of both drug literature references with correct
substance and finished product in information regarding both the drug
pharmacopoeia. substance and finished product.
4. 3.2.S.4.1 Specifications of the drug substance by the Submitted.
submitted.
5. 3.2.S.4.2 Analytical procedures for the drug substance Submitted.
used by the drug product manufacturer shall
be submitted.
6. 3.2.S.4.3 Verification studies of the drug substance Not submitted.
shall be submitted.
7. 3.2.S.7  Specifications of the drug substance Firm has submitted new stability data sheets
provided by the drug substance for the same batches of the drug substance
manufacturer are different from the with specifications provided by the drug
specification of the drug substance in the substance manufacturer.
submitted.
 Specifications of the drug substance has Firm has submitted new stability data sheets
mentioned “Contains NLT 90% and NMT for the same batches of the drug substance
115% of Cefepime HCl calculated on with assay specifications of 34% to 42% of
anhydrous and Arginine free basis” while Arginine and NLT 90% NMT 115% of
the stability data sheets for the drug Cefepime calculated on anhydrous and
substance has mentioned “NLT 83% of arginine free basis.
Cefepime calculated on anhydrous and
Arginine free basis”. Justification shall be
submitted.
8. 3.2.P.2.2 Justification shall be submitted for not Firm has submitted USP specifications for
performing PE against the innovator product. the drug product.
9. 3.2.P.5.2 Signed analytical procedures for the drug Submitted.
10. 3.2.P.8  Identification test, water content tests are
Firm has submitted revised stability data
sheets for all the three trial batches as per
not performed in the stability studies of
the drug product. decision of 293rd meeting of Registration
 Stability data sheets shall be as perBoard with inclusion of API lot number,
date of initiation of stability studies and total
decision of 293rd meeting of Registration
batch size. They also included Identification
Board with inclusion of API lot number,
test, water content tests in the revised
date of initiation of stability studies and
total batch size. stability data sheets.
API lot No. 11C0742107001.
23-11-2021 is the initiation date of stability
studies.
Firm has submitted commercial invoice No.
 Documents for the procurement of API CI-HXIP201910PK-074 dated 10-09-2021
with approval from DRAP shall be mentioning 10kg quantity of Cefepime HCL
submitted. L-Arginine with batch number
11C0742107001, Mfg. date 12-07-2021
attested by Assistant Director I&E, DRAP,
Islamabad dated 22-10-2021.
Submitted.
Each Vial contains:
Cefepime HCl with L-Arginine eq. to Cefepime …………. 2000mg.
C: Registration applications of deferred locally manufactured human drugs on Form 5.

763. Name and address of manufacturer/ M/s Alkemy Pharmaceuticals Labs Pvt Ltd, P/9, SITE,
Applicant Hyderabad
Brand Name + Dosage Form + Kemyfenac 100mg Tablet

Strength
Composition Each Tablet Contains:
Aceclofenac…100mg
Diary No. Date of R & I & fee Dy. No. 40382; 05.12.2018 PKR. 20,000/-; 05.12.2018
Pharmacological Group Antiinflammatory and antirheumatic products, non-steroids
Type of Form Form 5
Finished product Specification The firm has claimed in-house specifications
Approval status of product in Aceclofenac 100 mg film-coated Tablets. MHRA approved
Me-too status Anac 100mg Tablet. Reg. No. 81502
GMP status Latest GMP inspection report is required.
Remarks of the Evaluator(IX) The firm has applied for plain tablet. Coating composition are
mentioned thereof. However, the manufacturing outlines does
not depict coating process. The firm revised the manufacturing
outlines.
Revision of label claim to film-coated tablet is required.
Decision of 296th meeting of RB Deferred for:
 Submission of latest GMP inspection report.
 Revision of label claim to film-coated tablet along
with submission of applicable fee.
Evaluation by PEC  The firm was inspected on 06.10.2021, wherein acceptable
level of GMP compliance was reported.
 The firm did not revise the label claim, but resubmitted the
master formula.
 The firm submitted Rs. 7,500/- fee (Challan: 3050179428)
Decision of 313th meeting of Reg. Deferred for revision of label claim.
Board.
Reply submitted by the firm. Firm has submitted revised label claim as under;
Each film coated tablet Contains:
Aceclofenac …………….…100mg
Evaluation by PEC
Decision: Approved with innovator’s specifications and following label claim;
Each film coated tablet Contains:
Aceclofenac …………….…100mg
Applicant Hyderabad
Brand Name + Dosage Form + Kemsartan Tablet 5mg/160mg
Strength
Amlodipine as besilate…5mg
Valsartan…160mg
Pharmacological Group Antihypertensive
Type of Form Form 5
Finished product Specification USP
Pack size & Demanded Price 14’s; Rs. 340/-
Approval status of product in Exforge film-coated tablet 5/160mg. USFDA approved
Me-too status VALTAN -M 165 PLUS TABLET. Reg. No. 77206
Remarks of the Evaluator(IX)  The firm had applied for film-coated tablet. The firm
revised the label claim and mentioned the coating
composition in master formula.
 In master formula, the label claim is amlodipine as
besilate. However, in Form 5 it is amlodipine. The
firm did not clarify the same.
 The firm shall submit properly filled enclosure of
Form 5.
 The firm shall also revise amlodipine as besilate to
amlodipine besilate in master formula only.
 Submission of applicable fee for revision of label
claim to film-coated tablet.
 Revision of amlodipine to amlodipine as besilate in
Form 5.
 Submission of enclosure of Form 5.
 Revision of amlodipine as besilate to amlodipine
besilate in master formula only.
 Pack size & Demanded Price
Evaluation by PEC  The firm was inspected on 06.10.2021, wherein
acceptable level of GMP compliance was reported.
 The firm submitted Rs. 7,500/- fee (Challan:
131899163).
 The firm did not adjust the weight of amlodipine
besilate in master formula as salt factor.
th
Decision of 313 meeting of Reg. Deferred for adjustment of weight of amlodipine besilate in
Board. master formula as salt factor.
Reply submitted by the firm. Firm has submitted revised master formula for the applied
formulation wherein they have adjusted the weight of
amlodipine besylate by applying salt factor.
Evaluation by PEC 
Decision: Approved.
Applicant Hyderabad
Brand Name + Dosage Form + Kemsartan Tablet 10mg/160mg

Strength
Amlodipine as besilate…10mg
Valsartan…160mg
Pharmacological Group Antihypertensives
Type of Form Form 5
Pack size & Demanded Price 14’s; Rs. 448/-
Approval status of product in Exforge film-coated tablet 10/160. USFDA approved
Me-too status VALTAN -M 170 PLUS TABLET. Reg. No. 77207
Remarks of the Evaluator (IX)
 The firm has applied for film-coated tablet. The firm
revised label claim and mentioned the coating
composition in master formula.
 In master formula, the label claim is amlodipine as
besilate. However, in Form 5 it is amlodipine. The firm
did not clarify the same.
 The firm shall submit properly filled enclosure of Form 5.
 The firm shall also revise amlodipine as besilate to
amlodipine besilate in master formula only.
 Submission of applicable fee for revision of label claim to
film-coated tablet.
 Revision of amlodipine to amlodipine as besilate in Form
5.
 Submission of enclosure of Form 5.
 Revision of amlodipine as besilate to amlodipine besilate in
master formula only.
 Pack size & Demanded Price
 The firm submitted Rs. 7,500/- fee (Challan: 17055425)
 The firm did not adjust the weight of amlodipine besilate
in master formula as salt factor.
Decision of 313th meeting of Reg. Deferred for adjustment of weight of amlodipine besilate in
Board. master formula as salt factor.
amlodipine besylate by applying salt factor.
Decision: Approved.
Applicant Hyderabad
Brand Name + Dosage Form + Kem- Mont 5mg Tablet

Strength
Composition Each chewable tablet Contains:
Montelukast (as sodium)…….5mg
Pharmacological Group Leukotriene receptor antagonists
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 14’s, 30’s, 40’s, 50’s,60’s, 70’s, 80’s, 90’s, 100; Rs.
100 per tablet
Approval status of product in SINGULAIR® (montelukast sodium) Chewable Tablets.
Reference Regulatory Authorities. USFDA approved
Me-too status Nohist Chewable Tablet 5mg. Reg. No. 85712
Remarks of the Evaluator(IX) Revise “Montelukast sodium eq. to. Montelukast” to
“Montelukast sodium” in master formula only.

Revision of Montelukast sodium eq. to. Montelukast”
to “Montelukast sodium” in master formula only.
 The firm submitted Rs. 7,500/- fee (Challan:
126310600433)
 The firm did not adjust the weight of montelukast
sodium in master formula as salt factor.
Decision of 313th meeting of Reg. Deferred for adjustment of the weight of montelukast sodium
Board. as salt factor in master formula.
montelukast sodium in the master formula.
Decision: Approved.
Agenda of Evaluator PEC-XV

Cases of New sections & New licenses received on form 5-F:
767. Name, address of Applicant / M/s Fleming Pharmaceuticals 23 km Sheikhupura road-

Marketing Authorization Holder Lahore Pakistan.
Name, address of Manufacturing site. M/s Fleming Pharmaceuticals 23 km Sheikhupura road-
Lahore Pakistan.
☐ Importer
GMP status of the firm New DML granted on 13-09-2021.
facility dated 14-09-2021 specifying oral dry powder for
suspension (Penicillin),Capsule(Penicillin), Tablet
(Penicillin), Dry powder injectable(Penicillin),Dry
powder injectable(Carbapenem) sections.
☐ Export sale
Dy. No. and date of submission Dy.no. 8956 dated 03-04-2023
The proposed proprietary name / brand Flepicin 125 mg/5mL Suspension
name
Strength / concentration of drug of Each 5mL contains:
Active Pharmaceutical ingredient (API) Phenoxy methyl penicillin potassium eq to Phenoxy methyl
per unit penicillin…… 125mg
Pharmacotherapeutic Group of (API) penicillin antibiotics
Pharmaceutical form of applied drug White to off white well homogenized powder free from
extraneous matter filled in ambered glass bottle sealed with
flip and pp cap neatly labelled and packed in a unit carton with
insertion of a leaflet, plastic measuring cup 20 mL and plastic
spoon 5 mL on reconstitution with 40 mL of water off white
suspension with sweet taste is availed.
Reference to Finished product BP
specifications
The status in reference regulatory Phenoxymethylpenicillin 125 mg Suspension (MHRA
authorities Approved)
For generic drugs (me-too status) Penicillin V Suspension of M/s. Lisko Pakistan Pvt. Ltd.
Karachi, Reg.no. 006464
Name and address of API manufacturer. Hebei North China Pharmaceutical Huaheng Pharmaceutical
Co., Ltd. Xingwang Road, Biological Industry Zone,
Nanbaishe Town,
Zhao County, Shijiazhuang, China
Module-III Drug Substance: Firm has submitted detailed drug substance data related to
process and controls, specifications, analytical procedures and
its validation, batch analysis and justification of specification,
conducted at 30°C ± 2°C / 65% ± 5% RH for 48months.
drug product, specifications, analytical procedures, validation
of analytical procedures, batch analysis, justification of
Comparative Dissolution Profile product against the generic product Penicillin V Suspension
125 mg manufactured by Elite Pharma.
Analytical method Firm has submitted analytical method validation study reports
validation/verification of product for drug substance as well as drug product.
Manufacturer of API Hebei North China Pharmaceutical Huaheng Pharmaceutical Co.,
Ltd.
API Lot No. 20062105043
Description of Pack FPP is packed in ambered colored glass bottle, further packed in unit
(Container closure system) carton along with patient leaflet insert.
Batch Size 700 Units 700 Units 700 Units
No. of Batches 03
1. Reference of previous approval of Flemicillin Capsule 250 mg (322th Meeting)
applications with stability study data of Flemicillin Capsule 500 mg (322th Meeting)
the firm (if any) F-Amox Suspension 125mg/5mL (323rd Meeting)
F-Amox Suspension 250 mg/5mL (323rd Meeting)
Fletazo Injection 2.25 g (323rd Meeting)
Flementin Injection 1200 mg (324th Meeting)
2. Approval of API/ DML/GMP certificate Firm has submitted copy of GMP Certificate (No. Yi
of API manufacturer issued by concerned 20180010) dated 23-09-2021 issued By Hebei Province Drug
regulatory authority of country of origin. Administration China. The certificate specifies that the firm is
operating at satisfactory level of GMP compliance.
3. Documents for the procurement of API Firm has submitted copy of commercial invoice cleared on 27-
with approval from DRAP (in case of 01-2022 specifying 25.0 Kg of Phenoxymethyl penicillin
import). Potassium. The invoice is cleared by AD (I&E) DRAP,
Lahore.
4. Data of stability batches will be Firm has submitted analytical record for product testing.
etc.
5. Compliance Record of HPLC software Firm has submitted certificate of 21 CFR compliance for the
21CFR & audit trail reports on product HPLC system along with audit trail report for product testing.
testing
temperature and humidity monitoring of temperature and humidity monitoring of real time and
stability chambers (real time and accelerated stability chambers.
accelerated)
S.no. Sections Observations/Deficiencies/
Short-comings
1. 3.2.P.1 Formulation contain preservative Firm submitted the Antimicrobial
sodium benzoate, so preservative Effectiveness test report with the
effectiveness studies to be remarks that sodium Benzoate is
performed as per effective for use in oral product, while
recommendations of the antimicrobial effectiveness test
pharmacopoeia and shall be should be performed specifically on
submit. the applied product.
2. 3.2.P.1 Provide information including Firm replied that Diluent to be used
type of diluent, its composition, for reconstitution is water. Direction
quantity or volume which is to be for reconstitution is as: Add 30 mL
provided along with the applied water and shake well than add again
drug. 30 mL water to produce 100 mL
solution.
3. 3.2.P.2.2.1 Specify Product name and Firm replied that Pharmaceutical
Registration number of reference Equivalence study is performed
product against which against comparator product penicillin
pharmaceutical equivalence has V manufactured by Elite
been established.Further,Justify pharmaceutical with registration
why the pharmaceutical number 001852.
equivalence was studied against However, the registration status of
comparator product instead of comparator product against which the
using innovator / reference pharmaceutical equivalence has
product. established was not confirmed from
the available registered data.
4. 3.2.P.7 Please specify the volume size of Firm replied that Volume size of
ambered glass bottle used to fill ambered glass bottle used to fill the
the suspension since you have not suspension is 120 mL.
mentioned the volume size in the
requisite section.
5. 3.2.P.8 Chromatograms and audit trail Firm replied that We started working
reports of phenoxymethyl simultaneous on both products i.e
penicillin tablets has been Flepicin Suspension
attached in the dossier of (Phenoxymethylpenicillin Potassium)
suspension. Clarification is and Flepicin Tablets
required in this regard. (Phenoxymethylpenicillin Potassium)
and during binding of Flepicin
Suspension dossier, chromatograms
and audit trail reports of
phenoxymethyl penicillin tablets were
attached. Now we have attached
Chromatograms and audit trail reports
of phenoxymethyl penicillin
Suspension with this letter
6. 3.2.P.8 In-use stability studies of Firm replied that in-use stability study
reconstituted suspension is has already been conducted and data
required along with proposed in- has been attached in ANNEX III.
use storage statement and in-use However, Annexure-III is not attached
shelf-life. in the submitted reply.
Decision: Deferred for submission of following shortcomings:
 Submit product specific preservative effectiveness studies performed in accordance with USP General
Chapter <51>.
 In-use stability studies of reconstituted suspension is required along with proposed in-use storage
statement and in-use shelf-life.
768. Name, address of Applicant / Marketing M/s Fleming Pharmaceuticals 23 km Sheikhupura
Authorization Holder road- Lahore Pakistan.
Name, address of Manufacturing site. M/s Fleming Pharmaceuticals 23 km Sheikhupura
road- Lahore Pakistan.
☐ Importer
section dated 14-09-2021 specifying oral dry
powder for suspension
(Penicillin),Capsule(Penicillin), Tablet
(Penicillin), Dry powder
injectable(Penicillin),Dry powder
injectable(Carbapenem) sections.
☐ Export sale
The proposed proprietary name / brand name Flepicin 250 mg/5mL Suspension
Strength / concentration of drug of Active Each 5mL contains:
Pharmaceutical ingredient (API) per unit Phenoxy methyl penicillin potassium eq to Phenoxy
methyl penicillin…… 250mg
Pharmaceutical form of applied drug White to off white well homogenized powder free
from extraneous matter filled in ambered glass bottle
sealed with flip and pp cap neatly labelled and
packed in a unit carton with insertion of a leaflet,
plastic measuring cup 20 mL and plastic spoon 5 mL
on reconstitution with 60 mL of water off white
suspension with sweet taste is availed.
The status in reference regulatory authorities Phenoxymethylpenicillin 250 mg Suspension
(MHRA Approved)
For generic drugs (me-too status) Penicillin VK-DS Dry Suspension of M/s. Lisko
Pakistan Pvt. Ltd. Karachi, Reg.no. 070542
Name and address of API manufacturer. Hebei North China Pharmaceutical Huaheng
Pharmaceutical Co., Ltd. Xingwang Road,
Biological Industry Zone, Nanbaishe Town,
drug product.
and controls, specifications, analytical procedures
30°C ± 2°C / 65% ± 5% RH for 48 months.
Dissolution Profile their product against the generic product Penicillin V
Suspension 250 mg manufactured by Elite Pharma.
product.
Ltd.
API Lot No. 20062105043
Description of Pack FPP is packed in ambered colored glass bottle, further packed in unit
(Container closure system) carton along with patient leaflet insert.
Batch Size 700 Units 700 Units 700 Units
No. of Batches 03
1. Reference of previous approval of applications Flemicillin Capsule 250 mg (322th Meeting)
with stability study data of the firm (if any) Flemicillin Capsule 500 mg (322th Meeting)
F-Amox Suspension 125mg/5mL (323rd Meeting)
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP Certificate (No. Yi
manufacturer issued by concerned regulatory 20180010) dated 23-09-2021 issued By Hebei
authority of country of origin. Province Drug Administration China. The certificate
specifies that the firm is operating at satisfactory
approval from DRAP (in case of import). cleared on 27-01-2022 specifying 25.0 Kg of
Phenoxymethyl penicillin Potassium. The invoice is
cleared by AD (I&E) DRAP, Lahore.
data sheets etc.
product testing.
S.no. Sections Observations/Deficiencies/ Short-
comings
1. 3.2.P.1 Formulation contain preservative Firm submitted the Antimicrobial Effectiveness
sodium benzoate, so preservative test report with the remarks that sodium
effectiveness studies to be performed Benzoate is effective for use in oral product,
as per recommendations of while the antimicrobial effectiveness test should
pharmacopoeia and shall be submit. be performed specifically on the applied
product.
2. 3.2.P.1 Provide information including type of Firm replied that Diluent to be used for
diluent, its composition, quantity or reconstitution is water. Direction for
volume which is to be provided along reconstitution is as: Add 30 mL water and shake
with the applied drug. well than add again 30 mL water to produce 100
mL solution.
3. 3.2.P.2.2.1 Specify Product name and Registration Firm replied that Pharmaceutical Equivalence
number of reference product against study is performed against comparator product
which pharmaceutical equivalence has penicillin V manufactured by Elite
been established.Further,Justify why pharmaceutical with registration number
the pharmaceutical equivalence was 001852.
studied against comparator product However, the registration status of comparator
instead of using innovator / reference product against which the pharmaceutical
product. equivalence has established was not confirmed
from the available registered data.
4. 3.2.P.7 Please specify the volume size of Firm replied that Volume size of ambered glass
ambered glass bottle used to fill the bottle used to fill the suspension is 120 mL.
suspension since you have not
mentioned the volume size in the
requisite section.
5. 3.2.P.8 Chromatograms and audit trail reports Firm replied that We started working
of phenoxymethyl penicillin tablets simultaneous on both products i.e Flepicin
has been attached in the dossier of Suspension (Phenoxymethylpenicillin
suspension. Clarification is required in Potassium) and Flepicin Tablets
this regard. (Phenoxymethylpenicillin Potassium) and
during binding of Flepicin Suspension dossier,
chromatograms and audit trail reports of
phenoxymethyl penicillin tablets were attached.
Now we have attached Chromatograms and
audit trail reports of phenoxymethyl penicillin
Suspension with this letter
6. 3.2.P.8 In-use stability studies of reconstituted Firm replied that in-use stability study has
suspension is required along with already been conducted and data has been
proposed in-use storage statement and attached in ANNEX III.
in-use shelf-life. However, Annexure-III is not attached in the
submitted reply.
 Submit product specific preservative effectiveness studies performed in accordance with USP General
Chapter <51>.
 In-use stability studies of reconstituted suspension is required along with proposed in-use storage
statement and in-use shelf-life.
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy.no.8958 dated 03-04-2023
The proposed proprietary name / brand name Flepicin 250 mg Tablet
Strength / concentration of drug of Active Each Tablet contains:
Pharmaceutical ingredient (API) per unit Phenoxy methyl penicillin potassium eq. to Phenoxy
Pharmaceutical form of applied drug White colored oblong Film coated tablets scored
from both sides blistered and packed as 1 x 14’s in
unit carton with insertion of leaflet.
The status in reference regulatory authorities Phenoxymethylpenicillin 250 mg Tablet (MHRA
Approved)
For generic drugs (me-too status) Penicillin V Tablets of M/s Lisko Pharma, Karachi.
Reg.no. 011959
drug product.
30°C ± 2°C / 65% ± 5% RH for 48 months.
Dissolution Profile their product against the Innovator product Penicillin
VK 250 mg manufactured by Sandoz GMBH.,
Austria.
product.
Manufacturer of API Hebei North China Pharmaceutical Huaheng
Pharmaceutical Co., Ltd.
API Lot No. 20062105043
Description of Pack FPP is packed in Alu- PVC packaging that is further
(Container closure system) packed in cardboard unit carton along with patient leaflet
insert.
No. of Batches 03
1. Reference of previous approval of applications with Flemicillin Capsule 250 mg (322th Meeting)
stability study data of the firm (if any) Flemicillin Capsule 500 mg (322th Meeting)
3. Documents for the procurement of API with approval Firm has submitted copy of commercial invoice
from DRAP (in case of import). cleared on 27-01-2022 specifying 25.0 Kg of
4. Data of stability batches will be supported by attested Firm has submitted analytical record for product
respective documents like chromatograms, Raw data testing.
product testing.
S.no. Sections Observations/Deficiencies/ Response of the Firm
Short-comings
1. 3.2.P.2.2.1 In compliance of notification no. Firm has only submitted the one sided
14-1/2022-PEC dated 16th picture of outer carton which did not
January,2023 issued by DRAP, reflect the batch number, mfg. date ,
submit the expiry date of comparator product
image/picture/snapshot of against which Pharmaceutical
innovator /reference/comparator equivalence/Comparative dissolution
pack against which profile studies have been performed.
Pharmaceutical
equivalence/Comparative
dissolution profile studies have
been performed.
2. 3.2.P.8 BP monograph of Firm replied that they have used
phenoxymethyl penicillin Phenoxymethyl Penicillin Potassium in
potassium tablet recommend to reference standard and in sample that’s
calculate the assay content of why peak naming was given as
phenoxymethyl penicillin, Phenoxymethyl penicillin potassium.
justify how you had calculate the While calculating the assay as we have
content of phenoxymethyl taken weight equivalent to
penicillin by considering the phenoxymethyl penicillin and thus
peak of phenoxymethyl assay calculated is of phenoxymethyl
penicillin potassium, as penicillin.
chromatograms of assay
revealed that main peak achieved
at around 10 min was of
phenoxymethyl penicillin
potassium.
Decision: Approved.
The registration letter will be oisssued after submission of the details of the inovator /reference/comparator
pack against which Pharmaceutical equivalence/Comparative dissolution profile studies have been
performed.
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No.8959 dated 03-04-2023
The proposed proprietary name / brand name Flepicin 500 mg Tablet
Strength / concentration of drug of Active Each Tablet contains:
Pharmaceutical ingredient (API) per unit Phenoxy methyl penicillin potassium eq to Phenoxy
Pharmaceutical form of applied drug White colored oblong Film coated tablets scored
from both sides blistered and packed as 1 x 14’s in
unit carton with insertion of leaflet.
The status in reference regulatory authorities Phenoxymethylpenicillin 500 mg Tablet (MHRA
Approved)
For generic drugs (me-too status) Penicillin V Tablets of M/s Lisko Pharma, Karachi.
drug product.
30°C ± 2°C / 65% ± 5% RH for 48 months.
Dissolution Profile their product against the Innovator product Penicillin
VK 500 mg manufactured by Sandoz GMBH,
Austria
product.
Ltd.
API Lot No. 20062105043
Description of Pack FPP is packed in Alu- PVC packaging that is further packed in
(Container closure system) cardboard unit carton along with patient leaflet insert.
No. of Batches 03
approval from DRAP (in case of import). cleared on 27-01-2022 specifying 25.0 Kg of
data sheets etc.
product testing.
S.no. Sections Observations/Deficiencies/ Short- Response of the Firm
comings
3. 3.2.P.2.2.1 In compliance of notification no. 14- Firm has only submitted the one sided picture of
1/2022-PEC dated 16th January,2023 outer carton which did not reflect the batch
issued by DRAP, submit the number, mfg. date , expiry date of comparator
image/picture/snapshot of innovator product against which Pharmaceutical
/reference/comparator pack against equivalence/Comparative dissolution profile
which Pharmaceutical studies have been performed.
equivalence/Comparative dissolution
profile studies have been performed.
4. 3.2.P.8 BP monograph of phenoxymethyl Firm replied that they have used
penicillin potassium tablet Phenoxymethyl Penicillin Potassium in
recommend to calculate the assay reference standard and in sample that’s why
content of phenoxymethyl penicillin, peak naming was given as Phenoxymethyl
justify how you had calculate the penicillin potassium. While calculating the
content of phenoxymethyl penicillin assay as we have taken weight equivalent to
by considering the peak of phenoxymethyl penicillin and thus assay
phenoxymethyl penicillin potassium, calculated is of phenoxymethyl penicillin.
as chromatograms of assay revealed
that main peak achieved at around 10
min was of phenoxymethyl penicillin
potassium.
Decision: Approved.
The registration letter will be oisssued after submission of the details of the inovator /reference/comparator
pack against which Pharmaceutical equivalence/Comparative dissolution profile studies have been
performed.
771. Name, address of Applicant / Marketing M/s Fleming Pharmaceuticals 23 km Sheikhupura road-
Authorization Holder Lahore Pakistan.
Name, address of Manufacturing site. M/s Fleming Pharmaceuticals 23 km Sheikhupura road-
Lahore Pakistan.
☐ Importer
facility dated 14-09-2021 specifying oral dry powder for
suspension (Penicillin),Capsule(Penicillin), Tablet
(Penicillin), Dry powder injectable(Penicillin),Dry
powder injectable(Carbapenem) sections.
Status of application ☐ Generic Drug Product (GDP)
☒ New Drug Product (NDP)
☐ Export sale
The proposed proprietary name / brand Bi-penem 300 mg Injection
name
Pharmaceutical ingredient (API) per unit Bi-penem………. 300mg
Pharmacotherapeutic Group of (API) Carbapenem antibiotics
Pharmaceutical form of applied drug White or almost yellow crystalline powder.
Reference to Finished product Innovator’s
specifications
The status in reference regulatory Omegacin 300 mg Injection (PMDA Japan Approved)
authorities
For generic drugs (me-too status) No generic is available in Pakistan.
Name and address of API manufacturer. Shandong Anhong Pharmaceutical Co., Ltd.
No. 29 Huayuan Street Linyi County, Dezhou, Shandong,
China.
analytical procedures and its validation, batch analysis and
drug product.
closure system and stability studies of drug substance.
for 18 months.
Comparative Dissolution Profile product against the Generic product Biapen 300 mg
injection manufactured by BDR Pharma International pvt
LTD (India). Batch no. ABIBF0122, Mfg date 11-2021,
Exp date: 10-2023.
Manufacturer of API Shandong Anhong Pharmaceutical Co., Ltd.
API Lot No. 1010L91M
Description of Pack FPP is packed in glass vial and properly sealed labelled and packed in white
(Container closure system) colored unit cardboard box with insertion of leaflet.
No. of Batches 03
2. Approval of API/ DML/GMP certificate of Firm has submitted copy of GMP Certificate (No. LY
API manufacturer issued by concerned 2021001) dated 15-12-2021 issued by Linyi country
regulatory authority of country of origin. administration for market regulation. The certificate
specifies that the firm is operating at satisfactory level of
GMP compliance.
3. Documents for the procurement of API with Firm has submitted copy of commercial invoice cleared on
approval from DRAP (in case of import). 30-05-2022 specifying 0.50 Kg of Biapenem. The invoice
is cleared by AD (I&E) DRAP, Lahore.
4. Data of stability batches will be supported by Firm has submitted analytical record for product testing.
5. Compliance Record of HPLC software 21CFR Firm has submitted certificate of 21 CFR compliance for
& audit trail reports on product testing the HPLC system along with audit trail report for product
testing.
6. Record of Digital data logger for temperature Firm has submitted record of digital data logger for
Short-comings
1. 3.2.S.4.3 Firm has submitted analytical Firm has not submitted the requisite
method validation reports in document.
which they have not determined
limit of detection and
quantification in the validation of
analytical procedures section
3.2.P.4.3, submit complete
validation report including all the
parameters in accordance with
ICH guidelines.
2. 3.2.P.1 Submit information in section Firm replied that the Diluent used for
3.2.P.1 c) Description of reconstitution is 0.9% sodium chloride
accompanying reconstitution injection and must be reconstituted in
diluent(s) as per the guidance 100ml of 0.9% sodium chloride before
document approved by reconstitution.
Registration Board which
specifies that “Provide
information including type of
diluent, its composition, quantity
or volume, specifications (as
applicable) and regulatory status
in Pakistan (as applicable) for the
diluent which is to be provided
along with the applied drug”.
3. 3.2.P.2.2.1 Justify for not performing the Firm replied that due to unavailability
pharmaceutical equivalence of innovator product, Pharmaceutical
against the innovator product, equivalence was performed against
since you have performed the comparator product.
equivalence study against the
comparator product
4. 3.2.P.2.6 Submit data of compatibility of Firm submitted the compatibility data
the drug product along with of drug product along with its
reconstitution solvent in section reconstitution diluent.
3.2.P.2.6.
5. 3.2.P.3 According to the manufacturing Firm replied that it was a clerical
procedure given in section mistake, they used 0.9% sodium
3.2.P.3.3 filled vials are packed chloride injection for reconstitution.
with WFI in unit carton, how can
WFI will be used for
reconstitution when the literature
of innovator product revealed
that “do not use water for
injection as the solution does not
become isotonic.”
6. 3.2.P.5.2 Justify, how you had achieved the Firm replied that in the test method it
complies result of test of was written because of clerical error.
COMPLETENESS AND
CLARITY OF SOLUTIONS while
using the water, since the product
is sparingly soluble in water
according to the physicochemical
properties of innovator product
approved in PMDA Japan.
7. 3.2.P.8 Submit data in section 3.2.P.8.1 Firm submitted the in-use stability
as per the guidance document data of Bi-penem injection till 24
approved by Registration Board hours.
which specifies that “Summary of
additional stability studies (if
applicable) e.g. in-use studies for
drug products which are to be
reconstituted before use, along
with proposed in-use storage
statement and in-use shelf-life
shall be provided”.
Decision: Approved.
772. Name, address of Applicant / Marketing M/s Wahabsons pharmaceuticals (Pvt) Ltd, 4 km Bunner
Authorization Holder Road, Barikot,Swat
Name, address of Manufacturing site. M/s Wahabsons pharmaceuticals (Pvt) Ltd, 4 km Bunner
Road, Barikot,Swat
☐ Importer
GMP status of the firm Renewal of DML with the regularization of following
sections dated 29th April,2022:
Capsule Section, Oral Liquid Section.
Evidence of approval of manufacturing Firm has submitted copy of letter of grant of Renewal
facility of DML with the following sections dated 29th April,
2022 specifying Capsule Section, Oral Liquid Section.
Status of application ☒ Generic Drug Product (GDP)
☐ New Drug Product (NDP)
☐ Export sale
OMI 20mg Capsules
name
Pharmaceutical ingredient (API) per unit Omeprazole enteric coated pellets eq. to
Omeprazole………20mg
Pharmaceutical form of applied drug Capsules
USP specifications
specifications
The status in reference regulatory Omeprazole 20mg Capsule of M/s Sandoz Ltd UK
authorities (USFDA approved)
For generic drugs (me-too status) Risek 20 mg Capsule of M/s GETZ Pharma
(Reg # 019364)
drug product.
for 36 months.
Pharmaceutical Equivalence and Firm has submitted results of pharmaceutical equivalence
Comparative Dissolution Profile and CDP of test formulation with comparator product
Losec 20 mg Capsule (B # YEVA, Mfg Date: 09-2021,
Exp Date 08-2024) of M/s Astrazeneca (Manufactured by
M/s. Astrazeneca and Imported by M/s. Barrett &
Hodgson, Pakistan. The results of the tests of both
products were found to be within the specifications and
are comparable.
Manufacturer of API M/s Vision Pharmaceuticals, Plot No. 22-23, Industrial Triangle, Kahuta
Road, Islamabad.
API Lot No. OMP1158
Description of Pack
14’s blisters packed in unit carton
Batch No. Tr-001 Tr-001 Tr-001
Batch Size 2000 caps 2000 caps 2000 caps
No. of Batches 03
1. Reference of previous approval of applications NA.
2. Approval of API/ DML/GMP certificate of The firm has submitted copy of GMP Certificate for M/s
API manufacturer issued by concerned Vision pharma pvt Ltd, Lahore issued by DRAP Lahore.
regulatory authority of country of origin. It is valid till 10-02-2022.
3. Documents for the procurement of API with The firm has submitted copy of invoice for the purchase
approval from DRAP (in case of import). of omeprazole EC pellets from M/s vision pharma dated
14-07-2022.
Submitted
Submitted
Short-comings
1. 3.2.S.4.1-  Submit copies of the Drug Firm submit the specification and
3.2.S.4.2 substance specifications and analytical of drug substance by drug
analytical procedures used for product manufacturer only.
routine testing of the Drug Specification and Analytical Procedure
substance /Active of drug substance by drug substance
Pharmaceutical Ingredient as manufacturer is not submitted by the
per the guidance document firm.
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
both Drug substance & Drug
Product manufacturer is
required”.
2. 3.2.S.4.2 Further, justify the performance Firm replied that the drug substance
of dissolution testing on UV manufacturer uses UV method for
spectrophotometer by the drug analysis of drug substance but they use
substance manufacturer since HPLC method for both drug substance
the USP recommends test of and drug product.
dissolution on HPLC.
3. 3.2.S.4.3 Submit data of verification of Firm submitted the analytical method
analytical procedure of drug verification report in which the target
substance in section 3.2.S.4.3 as concentration 0.3 mg/ml instead of
per the guidance document 0.2mg/ml as per the submitted
approved by Registration Board analytical procedure.
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”.
4. 3.2.S.4.3 Submit batch analysis report of Firm submitted the Batch analysis
drug substance in section report of drug substance.
3.2.S.4.4 as per the guidance
document approved by
specifies that “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. A
discussion and justification
shall 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)”.
5. 3.2.P.2.2.1  Calculations of comparative Firm replied that 3 time points were
dissolution profile is not in used during Comparative dissolution
accordance with guidelines profile for buffer media at pH 6.8, the
approved in 293rd meeting of reading of 3rd time point are more than
Registration Board with 85%, therefore no further reading
reference to following points: required.
 For f2 calculations a
minimum of three time points
(excluding point zero) must
be used; mentioned the time
point which were considered
for the calculation of f2 value.
6. Provide complete calculations of Firm did not submit the reply of this
f2 value in all three
query. Later Firm submit the F2 value
physiological mediums. calculations in all three physiological
mediums.
7. 3.2.P.2.2.1 Submit data of Pharmaceutical Firm did not submit the reply of this
equivalence of the applied drug query.
with the innovator / reference/
comparator product and 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 and discussed”.
8. 3.2.P.5.3 Justify for performing the Firm replied that the Higher conc. Was
verification studies of assay taken to minimize errors in readings
procedure different from the and graphs and for better resolution.
method recommended in USP
monograph of “Omeprazole
delayed release capsule”.
Analytical method of drug
product specifies that
concentration of standard and
sample preparation is 0.2mg/ml
while you have performed
verification studies keeping the
target concentration 0.4mg/ml.
Justify how these studies
represent your analytical method
which is in complies with USP
monograph.
9. 3.2.P.8  Justify for keeping the run Firm replied that we perform tests and
time around 4.5-5mins as present the data as we received during
evident from the submitted the test and analysis and respectively
chromatogram, since the USP calculate the values according to
monograph recommends received data.
HPLC system of gradient
elution over run time of
25minutes.
 Justify how can the retention
time, peak area, peak height,
area% as well as height % of
sample solutions on all the
provided chromatograms of
both strengths were same
upto three digits.
10. 3.2.P.8  Submit raw data sheets and Firm replied that our HPLC Logs are
chromatograms of dissolution recorded manually and we can share
test since you have only pages of our log book for your
submitted the chromatograms consideration.
of assay.
 Submit Compliance Record
of HPLC software 21CFR &
audit trail reports on product
testing.
 Specification and analytical procedure of drug substance by drug substance manufacturer.
 Analytical verification report of drug substance performed in accordance with analytical procedure
given in section 3.2. S.4.2.
 Data of Pharmaceutical equivalence of the applied drug with the innovator / reference/ comparator
product and results of all the quality tests should be submitted.
 Analytical Verification report of drug product performed in accordance with USP monograph of
“Omeprazole Capsule”.
 Justification for keeping the run time around 4.5-5mins as evident from the submitted chromatogram,
while the USP monograph recommends HPLC system of gradient elution over run time of 25minutes.
 Justify how can the retention time, peak area, peak height, area% as well as height % of sample
solutions on all the provided chromatograms of both strengths were same upto three digits.
773. Name, address of Applicant / Marketing M/s Wahabsons pharmaceuticals (Pvt) Ltd, 4 km Bunner
Authorization Holder Road, Barikot,Swat
Name, address of Manufacturing site. M/s Wahabsons pharmaceuticals (Pvt) Ltd, 4 km Bunner
Road, Barikot,Swat
☐ Importer
GMP status of the firm Renewal of DML with the regularization of following
sections dated 29th April,2022:
Capsule Section, Oral Liquid Section.
Evidence of approval of manufacturing Firm has submitted copy of letter of grant of Renewal
facility of DML with the following sections dated 29th April,
2022 specifying Capsule Section, Oral Liquid Section.
Staspecificatintus of application ☒ Generic Drug Product (GDP)
☐ New Drug Product (NDP)
☐ Export sale
OMI 40mg Capsules
name
Pharmaceutical ingredient (API) per unit Omeprazole enteric coated pellets eq. to
Omeprazole………40mg
Pharmaceutical form of applied drug Capsules
USP specifications
specifications
The status in reference regulatory Omeprazole 40mg Capsule of M/s Sandoz Ltd UK
authorities (USFDA approved)
For generic drugs (me-too status) Risek 40 mg Capsule of M/s GETZ Pharma
(Reg # 022109)
drug product.
for 36 months.
Pharmaceutical Equivalence and Firm has submitted results of pharmaceutical equivalence
Comparative Dissolution Profile and CDP of test formulation with comparator product
Risek 40 mg Capsule (B# 004067, Mfg Date: 04-2022,
Exp Date 04-2025) of M/s. Getz Pharma,Karachi. The
results of the tests of both products were found to be
within the specifications and are comparable.
Manufacturer of API M/s Vision Pharmaceuticals, Plot No. 22-23, Industrial Triangle, Kahuta
Road, Islamabad.
API Lot No. OMP1158
Description of Pack
14’s blisters packed in unit carton
Batch No. Tr-004 Tr-005 Tr-006
Batch Size 2000 caps 2000 caps 2000 caps
No. of Batches 03
1. Reference of previous approval of applications NA.
2. Approval of API/ DML/GMP certificate of The firm has submitted copy of GMP Certificate for M/s
API manufacturer issued by concerned Vision pharma pvt Ltd, Lahore issued by DRAP Lahore. It
regulatory authority of country of origin. is valid till 10-02-2022.
3. Documents for the procurement of API with The firm has submitted copy of invoice for the purchase of
approval from DRAP (in case of import). omeprazole EC pellets from M/s vision pharma dated 14-
07-2022.
Submitted
Submitted
Short-comings
1. 3.2.S.4.1-  Submit copies of the Drug Firm submit the specification and
3.2.S.4.2 substance specifications and analytical of drug substance by drug
analytical procedures used for product manufacturer only.
routine testing of the Drug Specification and Analytical
substance /Active Procedure of drug substance by drug
Pharmaceutical Ingredient as substance manufacturer is not
per the guidance document submitted by the firm.
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”.
2. 3.2.S.4.2 Further, justify the performance Firm replied that the drug substance
of dissolution testing on UV manufacturer uses UV method for
spectrophotometer by the drug analysis of drug substance but they use
substance manufacturer since the HPLC method for both drug substance
USP recommends test of and drug product.
dissolution on HPLC.
3. 3.2.S.4.3 Submit data of verification of Firm submitted the analytical method
analytical procedure of drug verification report in which the target
substance in section 3.2.S.4.3 as concentration 0.3 mg/ml instead of
per the guidance document 0.2mg/ml as per the submitted
approved by Registration Board analytical procedure.
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”.
4. 3.2.S.4.3 Submit batch analysis report of Firm submitted the Batch analysis
drug substance in section report of drug substance.
3.2.S.4.4 as per the guidance
document approved by
specifies that “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. A discussion and
justification shall 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)”.
5. 3.2.P.2.2.1  Calculations of comparative Firm replied that 3 time points were
dissolution profile is not in used during Comparative dissolution
accordance with guidelines profile for buffer media at pH 6.8, the
approved in 293rd meeting of reading of 3rd time point are more than
Registration Board with 85%, therefore no further reading
reference to following points: required.
 For f2 calculations a minimum
of three time points (excluding
point zero) must be used;
mentioned the time point
which were considered for the
calculation of f2 value.
6. Provide complete calculations of Firm did not submit the reply of this
f2 value in all three physiological query
mediums.
7. 3.2.P.2.2.1 Submit data of Pharmaceutical Firm did not submit the reply of this
equivalence of the applied drug query.
with the innovator / reference/
comparator product and 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 and
discussed”.
8. 3.2.P.5.3 Justify for performing the Firm replied that the Higher conc. Was
verification studies of assay taken to minimize errors in readings
procedure different from the and graphs and for better resolution.
method recommended in USP
monograph of “Omeprazole
delayed release capsule”.
Analytical method of drug
product specifies that
concentration of standard and
sample preparation is 0.2mg/ml
while you have performed
verification studies keeping the
target concentration 0.4mg/ml.
Justify how these studies
represent your analytical method
which is in complies with USP
monograph.
9. 3.2.P.8  Justify for keeping the run Firm replied that we perform tests and
time around 4.5-5mins as present the data as we received during
evident from the submitted the test and analysis and respectively
chromatogram, since the USP calculate the values according to
monograph recommends received data.
HPLC system of gradient
elution over run time of
25minutes.
 Justify how can the retention
time, peak area, peak height,
area% as well as height % of
sample solutions on all the
provided chromatograms of
both strengths were same upto
three digits.
10. 3.2.P.8  Submit raw data sheets and Firm replied that our HPLC Logs are
chromatograms of dissolution recorded manually and we can share
test since you have only pages of our log book for your
submitted the chromatograms consideration.
of assay.
 Submit Compliance Record of
HPLC software 21CFR &
audit trail reports on product
testing.
 Specification and analytical procedure of drug substance by drug substance manufacturer.
 Analytical verification report of drug substance performed in accordance with analytical procedure
given in section 3.2.S.4.2.
 Data of Pharmaceutical equivalence of the applied drug with the innovator / reference/ comparator
product and results of all the quality tests should be submitted.
 Analytical Verification report of drug product performed in accordance with USP monograph of
“Omeprazole Capsule”.
 Justification for keeping the run time around 4.5-5mins as evident from the submitted chromatogram,
while the USP monograph recommends HPLC system of gradient elution over run time of 25minutes.
 Justify how can the retention time, peak area, peak height, area% as well as height % of sample
solutions on all the provided chromatograms of both strengths were same upto three digits.
774. Name, address of Applicant / Marketing M/s ICU Pharmaceuticals, Khewat No. 13/13, Khatooni
Authorization Holder No. 57/66 Mouza Mirpur Kehna, Tehsil Sharkpur, District
Sheikhupura
Name, address of Manufacturing site. M/s ICU Pharmaceuticals, Khewat No. 13/13, Khatooni
No. 57/66 Mouza Mirpur Kehna, Tehsil Sharkpur, District
Sheikhupura
☐ Importer
GMP status of the firm New License grant dated 28-04-2022.
Evidence of approval of manufacturing Firm has submitted copy of letter of grant of section dated
facility 29-04-2022 specifying Tablet (General) section, Oral Dry
Powder Suspension (General), Capsule (General), Sachet
(General).
☐ Export sale
The proposed proprietary name / brand Privo 25mg Tablet
name
Strength / concentration of drug of Active Each Tablet Contains: -
Pharmaceutical ingredient (API) per unit Levosulpiride………..25mg
Pharmacotherapeutic Group of (API) Antipsychotic
Pharmaceutical form of applied drug White colour round biconvex tablet having plain on both
sides.
Reference to Finished product Innovator’s Specification
specifications
Proposed Pack size 1x10’s, 2x7’s 2x10’s, 3x10’s, 5x10’s, 10x10’s
The status in reference regulatory Levosulpiride Aristo 25 mg tablets,
authorities AIFA Italy approved
For generic drugs (me-too status) Levopiride 25 mg Tablet of M/s Medera Pharmaceuticals
(Pvt.) Ltd. Islamabad (Reg.No. 066294)
Name and address of API manufacturer. Kimia Biosciences Limited
Formerly known as Laurel Organics Limited)
Village Bhondsi, Tehsil Sohna, District-Gurgaon
122102 Haryana, India
nomenclature, structure, general properties, Solubilities,
drug product.
for 36 months.
Comparative Dissolution Profile product against the comparator product Scipride 25mg
Tablet manufactured by Scilife Pharma Pvt. Ltd.
(Reg.no.057902)
Firm has submitted CDP results of their product against
the comparator product Scipride 25mg Tablet in 3
dissolution medias.

Manufacturer of API Kimia Biosciences Limited
Village Bhondsi, Tehsil Sohna, District-Gurgaon 122102 Haryana, India
API Lot No. KB/LSD/MC/22/001
Description of Pack
Alu-Alu Blister
Batch No. TT007 TT008 TT009
No. of Batches 03
1. Reference of previous approval of applications Two products were approved in 326th DRB Meeting
with stability study data of the firm (if any) and Registration letter was issued on 31st May, 2023.
CPX 250mg Reg. No.116595 & CPX 500mg Reg.
No.116596.
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP Certificate (No. 4-
manufacturer issued by concerned regulatory 138-I Drug 1-2019-8359) dated 18-11-19 issued by
authority of country of origin. Food and Drugs Control Administration Haryana
India.
3. Documents for the procurement of API with Firm has submitted copy of loan letter from DeMont
approval from DRAP (in case of import). research Laboratories Pvt. Ltd.
Borrowing Material qty. is 400g of Kimia
Biosciences Limited India. Copy of Form 5 and ADC
clearance Certificate issued by DRAP Lahore. ADC
Clearance Certificate No. E-1725322807958 Dated
24-June, 2022.
data sheets etc.
5. Compliance Record of HPLC software 21CFR & Not Applicable
comings
1. 3.2.S.4.1 Drug substance manufacturer Firm replied that “We perform the assay of drug
performed assay via potentiometric substance by manual titration and UV-Vis
titration while the drug product Spectrophotometric method. But we mentioned
manufacturer has performed assay of the results in COA only UV-Vis
drug substance on UV-Vis Spectrophotometric.”
spectrophotometer, justification is
2. 3.2.S.4.2 Submit Analytical procedure of drug Firm in their reply submitted the analytical
substance by drug substance procedure of drug substance by drug product
manufacturer , since you have only manufacturer only. While, the query is related
submitted the analytical procedure by to the submission of analytical procedure of
drug product manufacturer. drug substance by drug substance manufacturer.
3. 3.2.P.2.2.1 Justify, why the pharmaceutical  Firm replied that Comparative product
equivalence and comparative sample was easily available at the time of
dissolution profile was studied trial batches manufacturing so we use that
against comparator product instead of sample for Pharmaceutical equivalent
using innovator product/brand leader. study.
 Now they perform pharmaceutical
equivalence against innovator product
Levopraid 25mg & 50mg Tablet of Pacific
Pharma and accordingly revised
Pharmaceutical equivalence report has
submitted.
4. 3.2.P.2.2.1 Justify the submitted CDP data Firm has not submitted the reply against this
comparing the statement specify in query.
the available public assessment report
of reference product i.e. “The active
substance exhibits high solubility in
the proposed dissolution medium,
HCl 0.1N, as well as in the pH 4.5 and
pH 6.8 medium, since the percentage
dissolved is higher than 85% at 15
minutes (very rapidly dissolving
scenario)”.
5. 3.2.P.5.2 Please specify the reference of Not submitted the reply of this query.
acceptance criteria adopted for
dissolution test and submit along with
evidence of literature of innovator
product.
6. Justify for adopting 0.06N HCl as a Not submitted the reply of this query.
dissolution medium comparing the
CDP report in which it was clearly
revealed that drug is poorly dissolved
in acidic medium, further justify the
adopted dissolution medium
considering the absorption window of
drug in the physiological medium.
7. Justify for performing the assay of Firm replied that product monograph is not
drug product via UV-Vis available in any pharmacopeia, so we adopted
spectrophotometer instead of UV-Vis spectrophotometer method for stability
adopting HPLC method. study purpose and also performed validation of
UV-Vis spectrophotometer method. Once the
product is registered we will adopted HPLC
method and also validate it.
8. 3.2.P.5.3 Firm has submitted analytical method Firm submitted the Revised analytical method
validation reports in which they have validation protocol and report.
not determined limit of detection and
quantification in the validation of
analytical procedures, submit
complete validation report including
all the parameters in accordance with
ICH guidelines. Further, repeatability
of precision has been performed using
5 determinants while the ICH
guideline/general chapter of USP
recommends “a minimum of 9
concentrations/3 replicates each);
OR a minimum of 6 determinations at
100% of the test concentration”, so
scientific justification is required in
this regard.
9. 3.2. P.6 Provide certificate of analysis of Firm submitted the COA of working standard of
reference standard /working standard ATLAS Life Science, Ahmedabad, Gujarat,
used for testing of the product. India. While the API is imported from Kimia
Biosciences Limited Formerly known as Laurel
Organics Limited) Village Bhondsi, Tehsil
Sohna, District-Gurgaon 122102 Haryana,
India
10. 3.2.P.8 Submit valid GMP certificate of API Firm has submitted the same INVALID GMP
manufacturer. certificate of API Manufacturer (Valid from 18-
11-2019 to 17-11-2022)
 Submit Analytical procedure of drug substance by drug substance manufacturer, since you have only
submitted the analytical procedure by drug product manufacturer.
 Justify the submitted CDP data comparing the statement specify in the available public assessment
report of reference product i.e. “The active substance exhibits high solubility in the proposed dissolution
medium, HCl 0.1N, as well as in the pH 4.5 and pH 6.8 medium, since the percentage dissolved is higher
than 85% at 15 minutes (very rapidly dissolving scenario)”.
 Specify the reference of acceptance criteria adopted for dissolution test and submit along with evidence
of literature of innovator product.
 Justify for adopting 0.06N HCl as a dissolution medium comparing the CDP report in which it was
clearly revealed that drug is poorly dissolved in acidic medium.
 Submit valid GMP certificate of API manufacturer.
775. Name, address of Applicant / Marketing M/s ICU Pharmaceuticals, Khewat No. 13/13,
Authorization Holder Khatooni No. 57/66 Mouza Mirpur Kehna, Tehsil
Sharkpur, District Sheikhupura
Name, address of Manufacturing site. M/s ICU Pharmaceuticals, Khewat No. 13/13,
Khatooni No. 57/66 Mouza Mirpur Kehna, Tehsil
Sharkpur, District Sheikhupura
☐ Importer
section, Oral Dry Powder Suspension (General),
Capsule (General), Sachet (General).
☐ Export sale
The proposed proprietary name / brand name Privo 50mg Tablet
Pharmaceutical ingredient (API) per unit Levosulpride………..50mg
Pharmacotherapeutic Group of (API) Antipsychotic
Pharmaceutical form of applied drug White colour round biconvex tablet having plain on
both sides.
The status in reference regulatory authorities Levosulpiride Aristo 50 mg tablets,
AIFA Italy approved
For generic drugs (me-too status) Levopiride 50 mg Tablet of M/s Medera
Pharmaceuticals (Pvt.) Ltd. Islamabad
(Reg.No. 066397)
Name and address of API manufacturer. Kimia Biosciences Limited
Village Bhondsi, Tehsil Sohna, District-Gurgaon
122102 Haryana, India
Solubilities, physical form, manufacturers,
drug product.
properties, Solubilities, physical form,
30°C ± 2°C / 65% ± 5% RH for 36 months.
Scipride 50mg Tablet manufactured by Scilife
Pharma Pvt. Ltd.(Reg.no. 057903)
against the innovator’s product Scipride 50mg Tablet
in 3 dissolution medias.
product.
Manufacturer of API Kimia Biosciences Limited
Village Bhondsi, Tehsil Sohna, District-Gurgaon 122102 Haryana, India
API Lot No. KB/LSD/MC/22/001
Description of Pack
Alu-Alu Blister
No. of Batches 03
1. Reference of previous approval of applications Two products were approved in 326th DRB Meeting
with stability study data of the firm (if any) and Registration letter was issued on 31th may, 2023.
CPX 250mg Reg. No.116595 & CPX 500mg Reg.
No.116596.
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP Certificate (No. 4-
manufacturer issued by concerned regulatory 138-I Drug 1-2019-8359) dated 18-11-19 issued by
authority of country of origin. Food and Drugs Control Administration Haryana India.
Borrowing Material qty. is 400g of Kimia Biosciences
Limited India. Copy of Form 5 and ADC clearance
Certificate issued by DRAP Lahore. ADC Clearance
Certificate No. E-1725322807958 Dated 24-June,
2022.
5. Compliance Record of HPLC software 21CFR Not Applicable
comings
1. 3.2.S.4.1 Drug substance manufacturer Firm replied that “We perform the assay of drug
performed assay via potentiometric substance by manual titration and UV-Vis
titration while the drug product Spectrophotometric method. But we mentioned
manufacturer has performed assay of the results in COA only UV-Vis
drug substance on UV-Vis Spectrophotometric.”
spectrophotometer, justification is
2. 3.2.S.4.2 Submit Analytical procedure of drug Firm in their reply submitted the analytical
substance by drug substance procedure of drug substance by drug product
manufacturer , since you have only manufacturer only. While, the query is related to
submitted the analytical procedure the submission of analytical procedure of drug
by drug product manufacturer. substance by drug substance manufacturer.
3. 3.2.P.2.2.1 Justify, why the pharmaceutical  Firm replied that Comparative product sample
equivalence and comparative was easily available at the time of trial batches
dissolution profile was studied manufacturing so we use that sample for
against comparator product instead Pharmaceutical equivalent study.
of using innovator product/brand  Now they perform pharmaceutical
leader. equivalence against innovator product
Levopraid 25mg & 50mg Tablet of Pacific
Pharma and accordingly revised
Pharmaceutical equivalence report has
submitted.
4. 3.2.P.2.2.1 Justify the submitted CDP data Firm has not submitted the reply against this
comparing the statement specify in query.
the available public assessment
report of reference product i.e. “The
active substance exhibits high
solubility in the proposed dissolution
medium, HCl 0.1N, as well as in the
pH 4.5 and pH 6.8 medium, since the
percentage dissolved is higher than
85% at 15 minutes (very rapidly
dissolving scenario)”.
5. 3.2.P.5.2 Please specify the reference of Not submitted the reply of this query.
acceptance criteria adopted for
dissolution test and submit along
with evidence of literature of
innovator product.
6. Justify for adopting 0.06N HCl as a Not submitted the reply of this query.
dissolution medium comparing the
CDP report in which it was clearly
revealed that drug is poorly
dissolved in acidic medium, further
justify the adopted dissolution
medium considering the absorption
window of drug in the physiological
medium.
7. Justify for performing the assay of Firm replied that product monograph is not
drug product via UV-Vis available in any pharmacopeia, so we adopted
spectrophotometer instead of UV-Vis spectrophotometer method for stability
adopting HPLC method. study purpose and also performed validation of
UV-Vis spectrophotometer method. Once the
product is registered we will adopted HPLC
method and also validate it.
8. 3.2.P.5.3 Firm has submitted analytical Firm submitted the Revised analytical method
method validation reports in which validation protocol and report.
they have not determined limit of
detection and quantification in the
validation of analytical procedures,
submit complete validation report
including all the parameters in
accordance with ICH
guidelines.Further,repeatability of
precision has been performed using
5 determinants while the ICH
guideline/general chapter of USP
recommends “a minimum of 9
each); OR a minimum of 6
determinations at 100% of the test
concentration”, so scientific
justification is required in this
regard.
9. 3.2. P.6 Provide certificate of analysis of Firm submitted the COA of working standard of
reference standard /working ATLAS Life Science, Ahmedabad, Gujarat, India.
standard used for testing of the While the API is imported from Kimia
product. Biosciences Limited Formerly known as Laurel
Organics Limited) Village Bhondsi, Tehsil Sohna,
District-Gurgaon 122102 Haryana, India
10. 3.2.P.8 Submit valid GMP certificate of API Firm has submitted the same INVALID GMP
manufacturer. certificate of API Manufacturer (Valid from 18-
11-2019 to 17-11-2022)
 Justify the submitted CDP data comparing the statement specify in the available public assessment
report of reference product i.e. “The active substance exhibits high solubility in the proposed dissolution
medium, HCl 0.1N, as well as in the pH 4.5 and pH 6.8 medium, since the percentage dissolved is higher
than 85% at 15 minutes (very rapidly dissolving scenario)”.
 Specify the reference of acceptance criteria adopted for dissolution test and submit along with evidence
of literature of innovator product.
 Justify for adopting 0.06N HCl as a dissolution medium comparing the CDP report in which it was
clearly revealed that drug is poorly dissolved in acidic medium.
 Submit valid GMP certificate of API manufacturer.
Sheikhupura
Sheikhupura
☐ Importer
(General).
☐ Export sale
The proposed proprietary name / brand Thinvo 250mg Tablet
name
Strength / concentration of drug of Active Each film coated tablet contains: -
Pharmaceutical ingredient (API) per unit Azithromycin Dihydrate Eq. to
Azithromycin …………250mg
Pharmacotherapeutic Group of (API) Macrolides
Pharmaceutical form of applied drug White colour film coated round biconvex tablet having
plain on both side.
Reference to Finished product USP Specification
specifications
Proposed Pack size 1x6’s, 1x10’s 2x10’s,10x10’s
The status in reference regulatory Azithromycin 250mg film coated tablet
authorities USFDA approved
For generic drugs (me-too status) Azitma 250mg Tablet of M/s Sami Pharmaceuticals
Karachi (Reg.No. 074899)
3 Kilometer, Head Balloki Road, Phool Nagar, Kasur.
drug product.
for 24 months.
Comparative Dissolution Profile product against the innovator’s product Azitma 250mg
Tablet manufactured by Sami Pharmaceuticals. Pvt
Ltd.(Reg.no.074899)
the innovator’s product Azitma 250mg in 3 dissolution
medias. 1.2pH, 4.5pH & 6.8pH
API Lot No. AZM2207001
Description of Pack
Alu-Alu Blister
No. of Batches 03
1. Reference of previous approval of Two products were approved in 326th DRB Meeting and
applications with stability study data of the Registration letter was issued on 31th may, 2023. CPX
firm (if any) 250mg Reg. No.116595 & CPX 500mg Reg. No.116596.
01/2021-DRAP(FID-2036001-5101 dated 06-01-2021
3. Documents for the procurement of API with API Received from Local manufacturer as 4 kg sample for
approval from DRAP (in case of import). trail Purpose only.
5. Compliance Record of HPLC software Firm has submitted the audit trail on product testing
testing
and humidity monitoring of stability temperature and humidity monitoring of real time and
chambers (real time and accelerated) accelerated stability chambers.
comings
1. 3.2.S.4.2 Submit Analytical procedure of Firm submitted the analytical procedure of drug
drug substance by drug substance substance again by the drug product
manufacturer, since you have only manufacturer instead of submitting the analytical
submitted the analytical procedure procedure of drug substance by drug substance
by drug product manufacturer. manufacturer.
2. 3.2.S.4.2 Justify for adopting the assay Firm submitted the revised analytical procedure
procedure different from that of drug substance in accordance with USP
recommended by USP for monograph of Azithromycin.
Azithromycin Dihydrate raw
material.
3. 3.2.S.4.4 Justify for adopting the acceptance Firm submitted the revised COA of API in
criteria of assay different from that which the result of assay is in accordance with
recommended criteria by USP, USP monograph.
since you have mentioned the
results of assay in percentage on
the COA of API while USP
specify the limits in µg/mg.
4. 3.2.S.7 Specification of water content test Firm submitted the revised stability data of drug
mentioned on the stability data substance in which the specifications are in
sheet is not the recommended accordance with Azithromycin Dihydrate
criteria for the dihydrate labelled labelled API.
Azithromycin according to USP,
regard.
5. 3.2. P.6 Provide certificate of analysis of Firm submitted the COA working standard
reference standard /working supplied by API Manufacturer M/s. Citi
standard used for testing of the Pharma.
product.
Decision: Approved.
Sheikhupura
Sheikhupura
☐ Importer
(General).
☐ Export sale
The proposed proprietary name / brand Thinvo 500mg Tablet
name
Strength / concentration of drug of Active Each film coated tablet contains: -
Pharmaceutical ingredient (API) per unit Azithromycin Dihydrate Eq. to
Azithromycin …………500mg
Pharmacotherapeutic Group of (API) Macrolides
Pharmaceutical form of applied drug White colour film coated oval shape tablet having plain on
both side.
specifications
Proposed Pack size 1x6’s, 1x10’s 2x10’s,10x10’s
The status in reference regulatory Azithromycin 500mg film coated tablet
authorities USFDA approved
For generic drugs (me-too status) Zetro 500mg Tablet of M/s Getz Pharma Karachi
(Reg.No. 053120)
drug product.
for 24 months.
Comparative Dissolution Profile product against the innovator’s product Zetro 500mg
Tablet manufactured by Getz Pharma (Reg.no.053120)
the innovator’s product Zetro 500mg tablet in 3
dissolution medias. 1.2pH, 4.5pH & 6.8pH
API Lot No. AZM2207001
Description of Pack
Alu-Alu Blister
No. of Batches 03
01/2021-DRAP(FID-2036001-5101 dated 06-01-2021
3. Documents for the procurement of API with API Received from Local manufacturer as 4 kg sample for
approval from DRAP (in case of import). trail Purpose only.
5. Compliance Record of HPLC software Firm has submitted the audit trail on product testing
testing
comings
1. 3.2.S.4.2 Submit Analytical procedure of Firm submitted the analytical procedure of drug
drug substance by drug substance substance again by the drug product
manufacturer, since you have only manufacturer instead of submitting the analytical
submitted the analytical procedure procedure of drug substance by drug substance
by drug product manufacturer. manufacturer.
2. 3.2.S.4.2 Justify for adopting the assay Firm submitted the revised analytical procedure
procedure different from that of drug substance in accordance with USP
recommended by USP for monograph of Azithromycin.
Azithromycin Dihydrate raw
material.
3. 3.2.S.4.4 Justify for adopting the acceptance Firm submitted the revised COA of API in
criteria of assay different from that which the result of assay is in accordance with
recommended criteria by USP, USP monograph.
since you have mentioned the
results of assay in percentage on
the COA of API while USP
specify the limits in µg/mg.
4. 3.2.S.7 Specification of water content test Firm submitted the revised stability data of drug
mentioned on the stability data substance in which the specifications are in
sheet is not the recommended accordance with Azithromycin Dihydrate
criteria for the dihydrate labelled labelled API.
Azithromycin according to USP,
regard.
5. 3.2. P.6 Provide certificate of analysis of Firm submitted the COA working standard
reference standard /working supplied by API Manufacturer M/s. Citi
standard used for testing of the Pharma.
product.
Decision: Approved.
Sheikhupura
Sheikhupura
☐ Importer
GMP status of the firm New License
facility 29-04-2022 specifying Tablet (General) section.
☐ Export sale
The proposed proprietary name / brand P-Dext 20mg Tablet
name
Pharmaceutical ingredient (API) per unit Piroxicam (as Beta Cyclodextrin)……20mg
Pharmacotherapeutic Group of (API) Anti-inflammatory
Pharmaceutical form of applied drug Light yellow colour round biconvex tablet having plain on
both side.
Reference to Finished product Innovator’s Specification
specifications
The status in reference regulatory Brexin 20mg Tablet
authorities AIFA Italy approved
For generic drugs (me-too status) Woxicam 20mg Tablet of M/s Warafana Pharmaceuticals
(Reg.No. 072300)
Name and address of API manufacturer. Nantong Jinghua Pharmaceutical Co., Ltd.
No.20,3 Haibin Road, Yanhai Economic Development
Zone,Rudong, Nantong, Jiangsu, China.
drug product.
for 36 months.
Comparative Dissolution Profile product against the comparator product Felbex 20mg
Tablet manufactured by Martin Dow Pharma Pvt. Ltd.
the innovator’s product Felbex 20mg Tablet in 3
dissolution medias.
Manufacturer of API Nantong Jinghua Pharmaceutical Co., Ltd.
No.20,3 Haibin Road, Yanhai Economic Development Zone, Rudong,
Nantong, Jiangsu, China.
API Lot No. 20211206
Description of Pack
Alu-Alu Blister
No. of Batches 03
2. Approval of API/ DML/GMP certificate of Firm has submitted copy of GMP Certificate (No.
API manufacturer issued by concerned JS20180829 dated 01-06-2018 valid till 31-05-2023 issued
regulatory authority of country of origin. by China Food and Drugs Administration china
Borrowing Material qty. is 1kg of Nantong Jinghua
Pharmaceutical Co., Ltd. Copy of Form 5 and ADC
clearance Certificate issued by DRAP Lahore. ADC
Clearance Certificate No. E-1582822802698 Dated 12-
June, 2022.
testing
Short-comings
1. 3.2.S.4.2 Submit Analytical procedure Firm submitted the analytical procedure
of drug substance by drug of drug substance again by the drug
substance manufacturer, since product manufacturer instead of
you have only submitted the submitting the analytical procedure of
analytical procedure by drug drug substance by drug substance
product manufacturer. manufacturer.
2. 3.2.S.4.3 Firm has submitted analytical Firm submitted revised complete method
method validation reports in validation as per ICH guideline is
which they have not attached.
determined limit of detection
and quantification in the
validation of analytical
procedures, submit complete
validation report including all
the parameters in accordance
with ICH guidelines. Further,
repeatability of precision has
been performed using 5
determinants while the ICH
guideline/general chapter of
USP recommends “a minimum
of 9 determinations covering
the specified range for the
procedure (e.g., 3
concentrations/3 replicates
determinations at 100% of the
test concentration”, so
scientific justification is
3. 3.2.P.2.1 Justify the quantity of Firm replied that “as per API assay
Piroxicam Beta cyclodextrin results i.e. 9.42%, quantity of API per
i.e. 212.31mg used per tablet tablet is 212.31mg:
comparing the claim of 100/9.42x20=212.31mg per tablet.
innovator product i.e.
Piroxicam Beta cyclodextrin
191.2 mg eq. to piroxicam
20mg.
4. 3.2.P.2.2.1 Justify, why the Firm replied that Comparative product
pharmaceutical equivalence sample was easily available at the time of
and comparative dissolution trial batches manufacturing so we use
profile was studied against that sample for Pharmaceutical
comparator product instead of equivalent study
using innovator product/brand
leader.
5. 3.2.P.5.2 Justify how Firm replied that “As product monograph
UV-Vis
spectrophotometer method was is not available in any pharmacopeia, so
adopted for the testing of drug
we adopted UV-Vis spectrophotometer
product, since the testing method for stability study purpose and
method of drug substance also performed validation of UV-Vis
manufacturer for assay of spectrophotometer method. Once the
Piroxicam Beta cyclodextrin product is registered we will adopted
was based on HPLC. HPLC method and also validate it”.
6. 3.2.P.5.2 Submit the detailed procedure Firm replied that “As product is innovator
of dissolution testing, since specification and product monograph is
you have not submitted the not available in any pharmacopeia and
method of dissolution. dissolution test is not available in FDA
dissolution method, so we performed
only disintegration test. Once the product
is registered we will developed the
dissolution method and will performed it
on commercial scale product stability
batched”.
7. 3.2.P.5.2 Scientific justification is Firm replied We claimed Piroxicam as
required for calculation of beta cyclodextrin, so Piroxicam content
assay content of piroxicam is required for calculation purpose.
Beta cyclodextrin instead of
only piroxicam comparing the
label claim of applied
formulation.
8. 3.2.P.5.2 Justify why water content test Firm replied that The water content test
is not included in the finished is performed during the raw material
product specification, further testing stage, while the bulk
justify why water content test manufacturing test performed is LOD
was not performed during the (Loss on Drying). Additionally, when
stability studies. analysing the finished product sample
containing multiple inactive materials,
conducting a water content test on
Piroxicam beta cyclodextrin is not
feasible. Also testing record is attached
in BMR record.
9. 3.2.P.5.2 Justify why dissolution is not Firm in their reply stated that “As product
included in the finished is innovator specification and product
product specification, further monograph is not available in any
justify why dissolution test was pharmacopeia and dissolution test is not
not performed during the available in FDA dissolution method, so
stability studies. we performed only disintegration test.
Once the product is registered we will
developed the dissolution method and
will performed it on commercial scale
product stability batched”.
10. 3.2.P.5.2 Justify why content uniformity Firm replied that “Revised finished
test is not included in the product specification is attached. Further
finished product specification, we adopted uniformity of dosage units by
further justify why content weight variation test, Once the product is
uniformity test was not registered we will adopt the content
performed during the stability uniformity as per described in USP
studies general chapter”.Revised Finished
product specification & certificate of
analysis of finished product is attached.
11. 3.2.P.5.3 Firm has submitted analytical Firm submitted revised complete method
method validation reports in validation as per ICH guideline.
which they have not
determined limit of detection
and quantification in the
validation of analytical
procedures, submit complete
validation report including all
the parameters in accordance
with ICH guidelines. Further,
repeatability of precision has
been performed using 5
determinants while the ICH
guideline/general chapter of
USP recommends “a minimum
of 9 determinations covering
the specified range for the
procedure (e.g., 3
concentrations/3 replicates
determinations at 100% of the
test concentration”, so
scientific justification is
12. 3.2. P.6 Provide certificate of analysis Firm submitted the COA of working
of reference standard /working standard from M/s. Kaifeng
standard used for testing of the Pharmaceuticals (Group) Co. Ltd.
product. Henan, China while the API is imported
from Nantong Jinghua Pharmaceutical
Co., Ltd. No.20,3 Haibin Road, Yanhai
Economic Development Zone,Rudong,
Nantong, Jiangsu, China.
 Firm should include the dissolution test in the finished product analysis, accordingly submit the detailed
analytical procedure of dissolution test and submit Performance of dissolution test at next time point
of long term stability studies and CDP studies against the innovator/reference product using the same
newly developed dissolution method.
779. Name, address of Applicant / Marketing M/s. TriVista Pharmaceuticals
Name, address of Manufacturing site. M/s. TriVista Pharmaceuticals 8-KM, Taxila Khanpur
Road, District Haripur, Khyber Pakhtunkhwa.
☐ Importer
GMP status of the firm New License grant dated 28-04-2022
facility 29-04-2022 specifying Tablet (General) section and
Capsule (General).
☐ Export sale
The proposed proprietary name / brand Moxivista 400mg Tablet
name
Strength / concentration of drug of Active Each Film coated Tablet Contains: -
Pharmaceutical ingredient (API) per unit Moxifloxacin as HCl…..400mg
Pharmacotherapeutic Group of (API) Quinolone broad spectrum Antibiotic
Pharmaceutical form of applied drug Tablet.
specifications
The status in reference regulatory USFDA
authorities
For generic drugs (me-too status) Moxiget 400mg Tablet of M/s. Getz Pharma, Karachi
Reg.no. 047117
Name and address of API manufacturer. M/s. SAAKH Pharma Plot no. C-7/1, North Westren
Industrial Zone Port Qasim, Karachi.
drug product.
for 12 months.
Comparative Dissolution Profile product against the Comparator product Moxiget 400mg
Tablet of M/s. Getz Pharma, Karachi. Batch no. 239F31
Comparator product Moxiget 400mg Tablet of M/s. Getz
Pharma, Karachi. Batch no. 239F31 3 dissolution medias.
Manufacturer of API M/s. SAAKH Pharma Plot no. C-7/1, North Westren Industrial Zone Port
Qasim, Karachi.
API Lot No. 22GN30-10012
Description of Pack
Alu-Alu Blister
Batch No. PFT22E007 PFT22E008 PFT22E009
No. of Batches 03
1. Reference of previous approval of NA
firm (if any)
83/2020-DRAP (K) dated 23-06-2020 valid for 2 years.
3. Documents for the procurement of API with NA
4. Data of stability batches will be supported by Firm has submitted Raw data sheets, COA, summary data
attested respective documents like sheets.
testing
S.no. Sections Observations/Deficiencies/ Short-comings
1. 3.2.S.4.2 Submit Analytical procedure and specification of drug substance by drug product
manufacturer, since you have only submitted the analytical procedure by drug substance
manufacturer.
2. 3.2.S.4.3 Submit analytical method verification report of drug substance performed by drug
product manufacturer.
3. 3.2. S.5 Reference Standards or Materials
Provide certificate of analysis of reference standard /working standard used for testing
of the drug substance.
4. 3.2.S.7 The stability study data of drug substance submitted in section 3.2.S.7.3 is tested on
completely different specifications as provided in section 3.2. S.4. Justification is
required in this regard how this stability study data represents the same drug substance
for which the data in module 3.2.S is submitted. Further, justify for not performing the
test of pH, water determination test ,chloride and sulphate test during the stability studies.
5. 3.2.P.2.2.1 Justify, why the pharmaceutical equivalence and comparative dissolution profile was
studied against comparator product instead of using innovator product/brand leader.
6. 3.2.P.5.4 Provide batch analysis report of the stability batches in section 3.2.P.5.4.
7. 2.3.R.1.1 Please provide complete calculation of dispensed weight of drug substance per tablet
considering the water content and salt factor of active material.
New Cases of Form 5-F (Import Finished Product)

780. Name, address of Applicant / Importer M/s. Hospital Supply Corporation
Details of Drug Sale License of License No:0013
importer Address: 42, Darul Aman Housing Society, Karachi
Address of Godown: 46-E-2, Block-6, PECHS, Karachi
Renewal: NA
Name and address of marketing BIEM ILac Sanayi ve Ticaret A.S., Anittepe Mah, Turgut Reis
authorization holder (abroad) Cad. No.: 21 Tandogan Cnkaya, Ankara Turkey
Name, address of manufacturer(s) Mefar Ilac San A.S. Ramazanoglu Mahalles Ensar Caddesi No.2
Istanbul Turkey
Detail of certificates attached (CoPP, CoPP: Firm has submitted original, legalized copy of CoPP
Freesale certificate, GMP certificate) certificate (No.2021/3007) dated 01-10-2021 issued by Turkish
Medicines and Medical Devices Agency. 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
Pakistan. Furthermore the CoPP was valid till 01-10-2023.
Details of letter of authorization / sole Firm has submitted copy of letter of distribution certificate from
agency agreement BIEM ILac Sanayi ve Ticaret A.S., Anittepe Mah, Turgut Reis
Cad. No.: 21 Tandogan Cnkaya, Ankara Turkey. The letter
species that the manufacturer appoints M/s. Hospital Supply
Corporation to register their products in Pakistan. The
authorization letter is valid till 31-12-2024.
☒ Importer
these ☐ Bulk import and local repackaging
☐ Bulk import and local repackaging for export purpose only
Dy. No. and date of submission Dy.no.3416 Date: 04-02-2022
Details of fee submitted PKR 150,000/ dated: 28-09-2021
The proposed proprietary name / Biemexol 350mgI/ml vial (100ml)
brand name
Strength / concentration of drug of Each vial contains:
Active Pharmaceutical ingredient Iohexol……755mg/ml
(API) per unit (755mg Iohexol equivalent to 350mg I)
Pharmaceutical form of applied drug Injectable
Pharmacotherapeutic Group of (API) X-Ray Contrast Media
Reference to Finished product In-house specification/USP
specifications
Proposed Pack size 100ml vial
The status in reference regulatory USFDA Approved.
authorities
For generic drugs (me-too status) Omnipaque 350mgI/ML Vial (100ml)
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO QOS-PD template. Firm
has summarized information related to nomenclature, structure,
container closure system and stability studies of drug substance.
Name, address of drug substance Zhejiang Taizhou Hisyn Pharmaceutical Co. Ltd. Chemical and
manufacturer Medical Raw Materials Base, Linhai Park Zhejian Province
Zhejiang Starry Pharmaceutical Co. Ltd. No.1 Starry Road of
Xianju Zhejiang Province, China
Module-III Drug Substance: Firm has submitted detailed drug substance data for both sources
related to nomenclature, structure, general properties, solubilities,
procedures and its validation, batch analysis and justification of
specification, reference standard, container closure system and
Stability Studies of Drug Substance Firm has submitted stability study data of 3 batches of API at
(Conditions & duration of Stability accelerated as well as real time conditions. The real time stability
studies) data is conducted at 25℃±2, 60% RH±5%. The stability study
data is till 36 months.
Zhejiang Taizhou Hisyn Pharmaceutical Co. Ltd. Chemical and
Medical Raw Materials Base, Linhai Park Zhejian Province
Batch no.
H18920080501, H18920080502, H18920080503
Zhejiang Starry Pharmaceutical Co. Ltd. No.1 Starry Road of
Xianju Zhejiang Province, China
Batch no.
C006-0802003, C006-0802004, C006-0802005
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 established against Omnipaque
Comparative Dissolution Profile 350mgI/ML Vial (100ml)
Analytical method Firm has submitted analytical method validation studies for the
validation/verification of product applied product.
Container closure system of the drug Colorless type I Glass vial (100ml), bromobutyl closure, blue tear
product off cap
Stability study data of drug product, Firm has submitted stability study data of 2 batches of 50ml.The
shelf life and storage conditions 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 of 24 month has submitted.
INDICATIONS AND USAGE:
OMNIPAQUE (iohexol) injection is a radiographic contrast agent indicated for intrathecal, intravascular, oral,
rectal, intraarticular and body cavity use. OMNIPAQUE oral solution is indicated for oral use only in conjunction
with OMNIPAQUE injection administered intravenously for computed tomography (CT) of the abdomen.
DOSAGE AND ADMINISTRATION:
The concentration and volume required will depend on the indication, size and condition of the patient, and the
equipment and imaging technique used. For CT of the head and body, OMNIPAQUE may be used with an
automated contrast injection system or contrast media management system cleared for use with OMNIPAQUE.
See full prescribing information for complete dosing information.
Evaluation by PEC:
S.no. Sections Observations/Deficiencies/ Short-comings along with Response of the Firm
1. Submit valid drug sale license of importer Hospital supply corporation, since the submitted DSL was
expired on 29-06-2022.
Firm submitted the copy of valid DSL issued in the name of M/s. Hospital Supply Corporation 42,
Darul Aman Housing Society, Karachi (DSL no. 0237) and validity granted till 29/06/2024.
2. According to the composition table associated with CoPP of drug product, API iohexol comply USP
specification while the submitted COA of both API vendors claimed that their material complies EP
specification, so clarification is required in this regard.
Firm submit the explanation letter from Product License holder i.e. BIEM ILac Sanayi ve Ticaret A.S.,
Anittepe Mah, Turgut Reis Cad. No.: 21 Tandogan Cnkaya, Ankara Turkey, in which it is stated that
“during pharmaceutical development and first application in country of origin, first DMF of API
supplier Zhejiang Starry Pharmaceutical Co. Ltd. No.1 Starry Road of Xianju Zhejiang Province,
China was in compliance of USP. Accordingly, batch formula was established according to USP
specifications. Lately, starry pharmaceutical has update their specifications according to EP
specifications and get approval for CEP. Biem has applied for CEP submission variation in 03-08-
2016 and get approval for variation in 10.10.2016. Firm submitted the copy of variation letter issued
from Turkish Medicines and Medical Agency for the approval of updated European Pharmacopeia
certificate of conformity.
However, the CoPP issued in 2021 did not specify the post registration variation approved in 2016
related to the change of specification of API from USP to EP.
3. 3.2.S.4 Submit copies of the Drug substance specifications and analytical procedures used for
routine testing of the Drug substance /Active Pharmaceutical Ingredient by the drug
product manufacturer 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”.
Firm submit the specification table of drug substance which did not include the test of
related substance, test of free aromatic amine, test of iodide and test of ionic compounds
as per BP monograph. Further, firm submitted the analytical procedure used for routine
testing of drug substance.
4. 3.2.S.4.3 Submit data of verification of analytical procedure of drug substance 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”. Since you
have submitted the validation report of drug substance manufacturer.
Not submitted the requisite information instead submit the verification report of Bacterial
Endotoxin test..
5. 3.2.S.7 Justify for not performing the test of sterility, bacterial endotoxin test, ionic compound
test, free iodide test, ionic compound test, heavy metal test, residual solvent test and color
of solution test during the stability studies of drug substance as evident from the data of
both API suppliers.
Firm replied that the parameter such as ionic compound test, free iodide test, ionic
compound test, heavy metal test, residual solvent test and color of solution test are not
susceptible to change during storage and are not likely to influence quality, safety and
efficacy of iohexol, so they did not perform them in stability study.
However, these test are included in the specification of API and also the part of BP
monograph of API iohexol , further the shelf life specification may related to widened
the limit of specifications but the critical test may remain same both in release
specification and shelf life specification.
6. 3.2.P.2.2.1 Justify for not performing the test of free iodine, particulate matter, sterility and bacterial
endotoxin test while establishing the pharmaceutical equivalence against the reference
product.
 Product license holder replied that Product was developmental batches manufactured
in non-sterile R&D Laboratory, because of this sterility test and bacterial endotoxin
test was not performed.
 Further, excipients used for manufacturing of Biemexol are standard excipient used
in injectable solutions. Iohexol is very soluble in water. Trometamine dissolves in
water and it is used for increasing solubility in our formulation. Therefore,
particulate matter test was not performed in the developmental phase.
 In the formulation of the drug product, the only source for free iodine is the API
Iohexol. According to the analysis results (lower than 10 PPM) obtained from CoA
of API, the free iodine was evaluated as low risk for effecting of product quality.
Therefore, free iodine was not performed during the development phase. Also, it is
confirmed by stability data that active ingredient has not got negative effects on free
iodine and stability.
However, test of free iodine, particulate matter, sterility and bacterial endotoxin test are
the part of both BP and USP monograph.
7. 3.2.P.5.1 Justify for not adopting the USP or BP specification for finished product, since the
official monograph of iohexol injection is present in both BP and USP Pharmacopeia.
Firm replied that for specifications which limits given In-house methods as related
substances, assay and density-analysis methods are established following the USP
monographs.
Firm replied that for assay release and shelf life specification of Biemexol 350mg I/ml
vial containing solution for IA, IV injection are proposed as 90%-110% according to the
results obtained from analytical results of development batches, validation batches and
reference product.
However, the assay limit recommended in USP monograph of iohexol injection is 95-
105%.
8. 3.2.P.5.1 Justify for adapting the wider assay limits i.e. from 90-110% comparing the assay limit
recommended in USP monograph of iohexol injection i.e. 95-105%.
Firm replied that the assay release and shelf life specifications of Biemexol 350mgI/ml
vial containing solution for IA, IV Injection are proposed as 90.0%-110% according to
the results obtained from analytical results of developmental batches, validation batches
and reference product.
However, the assay limit recommended in USP monograph of iohexol injection is 95-
105%.
9. 3.2.P.8 Submit the batch size details of batches whose stability data has been submitted in
section 3.2. P.8.
Submit the stability data of drug product of 100ml filled volume vials since you have
submitted the data of 50ml and 200ml only.
Firm claimed that they applied bracketing for BIEMEXOL 350mgI/100ml SOLUTION
FOR Injection. The applied Bracketing Plan is as under:
Strength BIEMEXOL 350mgI/ml solution for Injection

Batch 1 2 3
Ambalage 50ml T T T
100ml
200ml T T T
Batch no. Batch size Batch size Submitted data

(Litre) (vials)
711001 (50ml) 80L 1,584 36-month real time
6 month accelerated
712002 (50ml) 80L 1,584 36-month real time
6 month accelerated
711001 (200ml) 36-month real time
6 month accelerated
712002 (200ml) 36-month real time
6 month accelerated
However, the firm submit only the data of 2 batches of both volumes, while the
Bracketing plan given by manufacturer is consisting of stability data of three batches of
both volumes of 50ml and 200ml. Further, the Justification of application of bracketing
may be required in context of container closure size and/or Fills as described in ICH
guidelines, which the manufacturer has not discussed in their bracketing plan.
Decision: Deferred for the submission of following shortcomings/justifications:
 Justify, how the CoPP issued in 2021 did not specify the post registration variation approved in 2016
related to the change of specification of API from USP to EP.
 Submit copies of the Drug substance specifications and analytical procedures used for routine testing
of the Drug substance /Active Pharmaceutical Ingredient by the drug product manufacturer.
 Submit data of verification of analytical procedure of drug substance in section 3.2.S.4.3 by the Drug
Product manufacturer for drug substance.
 Justification for not performing the test of sterility, bacterial endotoxin test, ionic compound test, free
iodide test, heavy metal test, residual solvent test and color of solution test during the stability studies
of drug substance as evident from the data of both API suppliers.
 Justification for not performing the test of free iodine, particulate matter, sterility and bacterial
endotoxin test while establishing the pharmaceutical equivalence against the reference product.
 Justify for not adopting the USP or BP specification for finished product, since the official monograph
of iohexol injection is present in both BP and USP Pharmacopeia.
 Justify for adapting the wider assay limits i.e. from 90-110% comparing the assay limit recommended
in USP monograph of iohexol injection i.e. 95-105%.
 Submit stability data of batch sizes in accordance with the CTD guidance document approved by
Registration Board. Further, submit the stability data of both 50ml and 200ml volumes in accordance
with the given bracketing plan and Justification the bracketing plan in context of container closure size
and/or Fills as described in ICH guidelines, which the manufacturer has not discussed in their
bracketing plan.
781. Name, address of Applicant / M/s: Sohail Corporation
Importer Address: Plot no 7, SR-5, Serai Quarters, Techno City Ware
house no 42, Karachi-Pakistan.
Details of Drug Sale License of License No: 239
importer Address: Plot no 7, SR-5, Serai Quarters, Techno City Ware
house no 42, Karachi-Pakistan.
Validity: 18-Nov-2027
Status: Stock, Exhibit to sell, License to sell drugs as distributor
by way of wholesale.
Name and address of marketing M/s Shandong Hualu Pharmaceutical Co., Ltd.
authorization holder (abroad) Address: No.1 Hualu Road Chipping Country, Shandong
Province, China.
Name, address of manufacturer(s) M/s Shandong Hualu Pharmaceutical Co., Ltd.
Address: No.1 Hualu Road Chipping Country, Shandong
Province, China.
Detail of certificates attached (CoPP, CoPP: Firm has submitted original, legalized CoPP certificate No:
Freesale certificate, GMP certificate) 202100723(1) Dated 07-04-2021 issued by The first branch of
regional Inspection of Shandong Drug Administration for Sodium
Chloride Injection 0.9g/100ml.
The CoPP confirms free sale status of the product in exporting
country as well as GMP status of the manufacturing site through
Also, firm has submitted GMP certificate no. SD20190868 valid
till 18-02-2024.
Details of letter of authorization / sole Firm has submitted letter of Sole Agency Agreement from
agency agreement Shandong Hualu Pharmaceutical Co., Ltd.
The letter specifies that the manufacturer appoints M/s Sohail
Corporation to register their products in Pakistan. This agreement
is valid till 25-12-2023.
☒ Importer
Intended use of pharmaceutical ☐ Domestic sale
The proposed proprietary name / 0.9% Sodium Chloride Injection 100ml.
brand name
Strength / concentration of drug of Each 100ml contains:
Active Pharmaceutical ingredient Each 100ml water contains Sodium Chloride …. 0.9g
(API) per unit
Pharmacotherapeutic Group of (API) API: Sodium Chloride
Therapeutic classification: Electrolyte supplements (deficiency.)
ATC code: B05XA03
specifications
Proposed Pack size In one carton 80 bottles of 100ml
Proposed unit price Rs 70/- per single bottle
The status in reference regulatory Normasil 0.9% (TGA Approved).
authorities
For generic drugs (me-too status) Not confirmed in 100ml.
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO QOS-PD template. Firm
has summarized information related to nomenclature, structure,
container closure system and stability studies of drug substance.
Name, address of drug substance M/s Shandong Feicheng Refined Salt Plant
manufacturer Address of the manufacturer (s): No.002, Feicheng City,
Shandong Province, China.
Module-III Drug Substance: Firm has submitted detailed drug substance data for both sources
related to nomenclature, structure, general properties, solubilities,
procedures and its validation, batch analysis and justification of
Stability Studies of Drug Substance Firm has submitted stability study data of 3 batches of API at
(Conditions & duration of Stability accelerated as well as real time conditions.
studies)
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 Firm has not submitted Pharmaceutical Equivalence studies
Comparative Dissolution Profile report
Analytical method Firm has submitted analytical method validation studies for the
validation/verification of product applied product.
Container closure system of the drug Sodium Chloride Injection is supplied in Polypropylene infusion
product bottle
Stability study data of drug product, Firm has submitted stability study data of 3 batches The
shelf life and storage conditions 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 of 3 batches is for 36 months
Evaluation by PEC:
Section Observation Firm’s response

no.
3.2.S.4 Analytical method verification Firm submitted the analytical verification report of assay
studies for the drug substance shall of drug substance performed by drug product
be submitted from the drug product manufacturer.
manufacturer.
3.2.P.2.2.1 Pharmaceutical equivalence against Firm has submitted the comparison table of critical quality
the innovator drug product shall be attributes between self-developed formulation of M/s.
submitted. Shandong Hualu Pharmaceutical Co. Ltd and Reference
Listed Drug (name of manufacturer and batch detail is not
mentioned). Equivalence report did not include the test of
Iron, test of particulate matter in injection and Bacterial
Endotoxin test as per USP monograph.
Decision: Deferred for submission of details of Reference Listed product including name, manufacturing
date, expiry date etc. against which pharmaceutical equivalence is submitted
CASE OF EXPORT FACILITATION:

Export Facilitation: Applications was received through letter No.F.1-6/2019-PR-I (EFD) dated 02-06-2023.
“M/s Vision Pharmaceuticals (Pvt.) Ltd. have achieved benchmark OF USD 756,000 as defined in the Board’s
decision during fiscal year 2021-2022. In this regard, please find the (1 molecule) 01 products applications
submitted by the firm.”
782. Name, address of Applicant / M/s Vision Pharmaceuticals (Pvt.) Ltd.,
Marketing Authorization Holder Plot # 22-23 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.
Status of the applicant ☐Manufacturer
☐ Importer
Status of application ☐New Drug Product (NDP)
☒Generic Drug Product (GDP)
Details of fee submitted PKR 75,000/-: dated 17-10-2022 (6903530207)
The proposed proprietary name /
Visotol 200mcg Tablet
brand name
Strength / concentration of drug of Each Tablet Contains:
Active Pharmaceutical ingredient Misoprostol Dispersion USP eq. to Misoprostol………200 mcg
(API) per unit
Pharmacotherapeutic Group of (API) Gastrointestinal Agents (Synthetic Prostaglandins)

Innovator’s Specifications
specifications
Proposed Pack size Pack Size: 10’s , 28’s
Cytotec 200mcg Tablets (MHRA)
authorities
For generic drugs (me-too status) Brand Name: Breeky 200mcg Tablet
Registration No: 073698
Manufacturer: Sami Pharmaceuticals
GMP status of the Finished product New license granted on 03/01/2022
manufacturer Tablet Section Approved.
Name and address of API MISOPROSTOL 1% DISPERSION:
manufacturer. Manufacturer: Vision Pharmaceuticals (Pvt.) Limited
Manufacturing Site:
Plot No. 22-23, Industrial Triangle Kahuta Road,
Module III (Drug Substance) The firm as submitted detail of nomenclature, structure, general
properties, solubilities, physical form, manufacturers, description
of manufacturing process and controls, specifications, analytical
procedures and its verification, batch analysis and justification of
stability studies of drug substance
Accelerated: 30°C ±

Minutes of 330 Meeting of Registrationboard Held ON 24 TO 26 JULY, 2023

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Minutes of 330 Meeting of Registrationboard Held ON 24 TO 26 JULY, 2023

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MINUTES OF 330TH MEETING OF REGISTRATIONBOARD HELD

ON 24TH TO 26TH JULY, 2023

Item Detail of Item Page No

I. Division of Pharmaceutical Evaluation & Registration ---------

II. Division of Biological Evaluation & Research ------------------- 1746-1822

Drug Regulatory Authority of Pakistan

Minutes of 330th meeting of Registration Board (24th to 26th July, 2023) 1

Following members attended the meeting:

Lt. Gen.(R) Prof. Dr. Karamat A. Karmat, (HI-M, SI-M),

Dr. Imranullah Khan, Senior Drug Analyst. Rep of Director

4. Dr. Ayesha Yaqoob, DDC, Rep of Director DTL, Govt. of Member

6. Mr. Ghulam Mujtaba, Rep. of IPO, Islamabad Member

7. Syed Adnan Rizvi, Director DTL. Govt. of Sindh. Karachi Member

8. Dr. Mahvash Ansari, Deputy Director, Rep. of Director, Member

12. Dr. Qurban Ali, Ex-Director General, NVL, Veterinary Co-opted

Minutes of 330th meeting of Registration Board (24th to 26th July, 2023) 2

Pharmaceutical Evaluation Cell (PEC)

Sr. No Name of Evaluator Title

3. Mst. Farzana Raja Evaluator PEC-IV

4. Mst. Iqra Aftab Evaluator PEC-V

5. Mr. Adil Saeed Evaluator PEC-IX

7. Dr. Farhadullah Evaluator PEC-XI

8. Mr. Shahid Nawaz Evaluator PEC-XIII

9. Ms. Saima Hussain Evaluator PEC-XV

11. Mr. M. Tahir Waqas Evaluator PEC-XXI

13. Mr. Muneeb Ahmed Cheema Deputy Director (PE&R)

14. Mr. Salateen Waseem Philip Deputy Director (PE&R)

Minutes of 330th meeting of Registration Board (24th to 26th July, 2023) 3

Applicant firm M/s Novamed Pharmaceuticals(Pvt.)Ltd ., 28km

Minutes of 330th meeting of Registration Board (24th to 26th July, 2023) 4

Applicant firm M/s Novamed Pharmaceuticals(Pvt.)Ltd ., 28km

Minutes of 330th meeting of Registration Board (24th to 26th July, 2023) 5

Minutes of 330th meeting of Registration Board (24th to 26th July, 2023) 6

Minutes of 330th meeting of Registration Board (24th to 26th July, 2023) 7

Applicant firm M/s WnsFeild Pharmaceutical Industrial Estate Hattar Haripur

Applicant firm M/s WnsFeild Pharmaceutical Industrial Estate Hattar Haripur

Minutes of 330th meeting of Registration Board (24th to 26th July, 2023) 8

Applicant firm M/s WnsFeild Pharmaceutical Industrial Estate Hattar Haripur

Minutes of 330th meeting of Registration Board (24th to 26th July, 2023) 9

Applicant firm M/s WnsFeild Pharmaceutical Industrial Estate Hattar Haripur

Minutes of 330th meeting of Registration Board (24th to 26th July, 2023) 10

Minutes of 330th meeting of Registration Board (24th to 26th July, 2023) 11

Minutes of 330th meeting of Registration Board (24th to 26th July, 2023) 12

Applicant firm M/s Hudson Pharma Private Limited.

Minutes of 330th meeting of Registration Board (24th to 26th July, 2023) 13

Minutes of 330th meeting of Registration Board (24th to 26th July, 2023) 14

Minutes of 330th meeting of Registration Board (24th to 26th July, 2023) 15

Minutes of 330th meeting of Registration Board (24th to 26th July, 2023) 16

Applicant firm M/s Hudson Pharma Private Limited.

16. Name, address of Applicant / Marketing M/s Health Care Pharmaceuticals.

Minutes of 330th meeting of Registration Board (24th to 26th July, 2023) 17

Minutes of 330th meeting of Registration Board (24th to 26th July, 2023) 18

Minutes of 330th meeting of Registration Board (24th to 26th July, 2023) 19

Minutes of 330th meeting of Registration Board (24th to 26th July, 2023) 20

Minutes of 330th meeting of Registration Board (24th to 26th July, 2023) 21

Minutes of 330th meeting of Registration Board (24th to 26th July, 2023) 22

Minutes of 330th meeting of Registration Board (24th to 26th July, 2023) 23

Applicant firm M/s Biogen Pharmaceuticals 8Km, Chakbeli Road Rawat,

Minutes of 330th meeting of Registration Board (24th to 26th July, 2023) 24

Applicant firm M/s Biogen Pharmaceuticals 8Km, Chakbeli Road Rawat,

Minutes of 330th meeting of Registration Board (24th to 26th July, 2023) 25

Applicant firm M/s Biogen Pharmaceuticals 8Km, Chakbeli Road Rawat,

Minutes of 330th meeting of Registration Board (24th to 26th July, 2023) 26