Minutes of 281st Meeting of Registration Board

MINUTES OF 281st MEETING OF REGISTRATION BOARD
HELD ON 11TH TO 13TH APRIL, 2018

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Item No. Detail of Item Pages

I. Confirmation of Minutes: 3
th
a. Minutes of 279 meeting of Registration Board
b. Minutes of 280th meeting of Registration Board
II. Comments of Director DTL, Punjab. 4
III. Division of Pharmaceutical Evaluation &Registration 5-536
● Pharmaceutical Evaluation Cell (PEC) 4-455
● Registration-I 456-464
● Registration-II 465-480
● Registration-III 481-494
● Registration-IV 495-513
● Registration-V 514-521
● RRR Section 522-536
IV. Division of Biological Evaluation & Research 537-584
V. QA & LT Division 585-598
VI. Additional Agenda 599
A. Pharmaceutical Evaluation Cell (PEC)
B. Pharmacy Services Division
C. Registration-I
D. Registration-II
E. Registration-III
F. Registration-IV
G. Registration-V
H. Division of Biological Evaluation & Research
Drug Regulatory Authority of Pakistan

T.F. Complex, Mauve Area, G 9/4
Islamabad.
Minutes of 281st Meeting of Registration Board (11th-13th April, 2018) Page 1

281st meeting of Registration Board was held on 11 – 13th April, 2018 in the Committee
Room, Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The meeting was chaired by
Dr. Obaidullah, Director, Pharmaceutical Evaluation & Registration Division, DRAP. The
meeting started with recitation of the Holy Verses. The meeting was attended by the following:-
1. Dr. Rafeeq Alam Khan, Member
Meritorious Professor / Chairman,
Faculty of Pharmacy, Univeristy of Karachi.
2. Prof.Dr.Ghulam Sarwar, Dean, Member
Faculty of Pharmacy, Jinnah University for Women, Karachi
3. Dr.Qurban Ali, Member
Ex-Director General, NVL/ Veterinary Expert
4. Dr. Amanullah Khan, Member
Director, Drugs Testing Laboratory, Quetta
Government of Balochistan
5. Dr. Muzzamil Waheed, Member
Director, Drugs Testing Laboratory, Lahore
Government of Punjab
6. Dr. Muhammad Khalid Khan, Member
Director, Drugs Testing Laboratory, Peshawar
Government of Khyber Pakhtunkhwa.
7. Syed Muzaffar Ali Jafri, Member
Director, Drugs Testing Laboratory, Karachi
Government of Sindh.
8. Mr. Muhammad Aslam Member
Assistant Draftsman-II, Ministry of Law & Justice
9. Mr. Nasir Mehmood Zahid, Member
Deputy Director, Representative of IPO
10. Dr. Noor-us-Saba Member
Director, as representative of Division of Biological Evaluation &
Research, DRAP
11. Mr. Abdul Sattar Sohrani, Deputy Director, Member
as Representative of QA&LT Division, DRAP
12. Dr.Muhammad Akram, Co-Opted
Animal Husbandry Commissioner, M/o NFS&R, Islamabad. Member
13. Mr. Abdullah, Secretary
Additional Director (PE&R), DRAP.
Mr. Ehsan Awan and Ch. Muhammad Yousaf (PPMA), Mr. Nadeem Alamgir (Pharma
Bureau) and Mr. Kamran Anwar (PCDA) attended the meeting as observers.
Mr. Zaheeruddin M.Babar (Dy.Director-Reg.I/IV), Mr.Babar Khan (Dy.Director-Reg.III /
Incharge PEC) and Mr.Muhammad Amin (Dy. Director-Reg.II) and relevant Assistant Directors
assisted in presenting the agenda of PE&R Division. Mst. Sadaf Ahmad (Assistant Director
QA/LT) assisted in presenting the agenda of QA & LT Division. Mr. Muhammad Sarfraz and Mr.
Muhammad Khalid (Assistant Directors) assisted in presenting the agenda of Biological Drugs
Division.

Item No. I: Confirmation of Minutes:
a. Minutes of 279th meeting of Registration Board.

279th meeting of Registration Board was held on 28th February to 2nd March, 2018. The
draft minutes were circulated among the members of meeting on 4th April, 2018 with the request
to forward their comments (if any) within five days. Director, DBER pointed out minutes
regarding additional agenda are missing. Accordingly, same has been incorporated in minutes.
Director DTL forwarded his comments as these were not related to any particular case of the
agenda. However, comments of Director DTL have been taken as agenda item in instant meeting.
Accordingly, final minutes were approved by Chairman, Registration Board.
Decision: Registration Board confirmed the minutes as approved by Chairman,
Registration Board.
b. Minutes of 280th meeting of Registration Board.

280th meeting of Registration Board was held on 15th March, 2018. The partial minutes of
Item No. II (References sent by the Central Licensing Board) were prepared and signed by all
members of Registration Board on the day of meeting. The remaining draft minutes were circulated
among the members of meeting on 5th April, 2018 with the request to forward their comments (if
any) within five days. None of the members disagreed the draft minutes. Accordingly, final
minutes were approved by Chairman, Registration Board.
Decision: Registration Board confirmed the minutes as approved by Chairman,

Registration Board.

Item No. II Comments of Director DTL Lahore for 279th Drug Registration Board (DRB)
Meeting:
1. All regulatory Drug Testing Laboratories e.g. NIH, CDL, all Provincial DTLs etc.
shall be advised to achieve the ISO/ IEC 17025 accreditation (and WHO Pre-qualification)
to standardize the quality of analysis by using qualified laboratory staff, analytical
equipment and participation in global ILT and PT schemes.
2. Anti-microbials, anti-tuberculosis, anti-viral and anti-malarial drug products shall be
registered after satisfactory evaluation of pre-registration analytical results,
Bioequivalence (BE) studies and Comparative Dissolution Profile (CDP) with innovator
drug product to avoid any possible drug resistance against the particular indication.
3. In case of personal hearing cases regarding Out of Specifications (OOS) results
reported by any regulatory laboratory, a detailed root cause analysis (RCA) shall be
carried out by the manufacturer/ importer of drug products and shall be submitted to
DRAP in advance for any deliberations if required in DRB meeting(s).
4. Primary/ Secondary Reference Standards (Traceable to Primary Reference
Standard) shall be used for drug product analysis by all regulatory labs and pharmaceutical
manufacturers, where possible.
5. Import of innovator sample from ICH countries shall be controlled by DRAP for
R&D purposes e.g. CDP and CDP shall be performed by using Pharmacopoeial
Dissolution apparatus (14 Vessels) in the presence of DRAP panel as per the US FDA
guidelines using all mediums e.g. Acid, Base etc.
6. For drug products whose monographs have been published in Pharmacopoeia,
timeline e.g. 06 or 12 months for shifting of all drug product specifications from
Manufacturer (MS) to Pharmacopoeial Specifications shall be issued by DRAP to the
manufacturers and after this timeline (renewal of registration) all regulatory drug testing
laboratories shall analyze those drug products using Pharmacopoeial Specifications only.
Decision: Registration Board appreciated the efforts of Director DTL Lahore,
Government of Punjab for his valuable input. It was apprised that
Registration Board has already taken various steps for further enhancing
quality parameters like adaptation of CTD as registration dossier,
investigation / root cause analysis for Out of Specifications (OOS) results,
amendment in Drug Specification Rules, 1976, etc. However, the Board
further decided as follows:
a. Registration Board will sensitize and emphasize Federal and Provincial
Drug Testing Laboratories to achieve the relevant ISO certification /
accreditation and WHO Pre-qualification, use of primary / secondary
reference standards (traceable to primary reference standard) for drug
product analysis, etc.
b. QA&LT Division, DRAP shall be advised to permit import of
innovator or licensed comparator finished pharmaceutical product for
conducting comparative dissolution profile as required for drug
product development.
c. Pharmaceutical manufacturers shall be advised for use of primary/
secondary reference standards (traceable to primary reference
standard) for drug product analysis of registered products.

Item No. III Division of Pharmaceutical Evaluation & Registration
S.No. Details
Case No. 01 Review of formulation
Case No. 02 Registration applications for local manufacturing of (Human) drugs
a) New cases
b) Deferred cases
Case No. 03 Registration applications of newly granted DML or New section (Human)
a. New DML
b. New/Additional section(s)
c. Deferred cases
Case No. 04 Registration applications for local manufacturing of (veterinary) drugs

a. Routine Applications
b. Deferred Cases
Case No. 05 Registration applications of newly granted DML or New section (Veterinary)
a. New DML /section
Case No. 06 Registration applications of drugs for which stability study data is required
to be verified
a. Verification of stability study data
b. Exemption from onsite verification of stability data
Case No. 07 Registration applications of import cases
a. Import routine cases (Human)
b. Import routine cases (Veterinary)
c. Import Deferred cases
i. Human
ii. Veterinary
Registration applications of categories to be considered on priority
Case No. 08 a. Applications for registration of drugs or Local Manufacturing
b. Export Facilitation
c. Finished Import (Human)
d. Finished Import (Veterinary)
Case No. 09 Miscellaneous cases
Total Cases: 958

Pharmaceutical Evaluation Cell:
Sr. No Name of Evaluator Title
1. Mr. Muhammad Tahir Waqas Evaluator PEC-I
2. Mr. Ammar Ashraf Awan Evaluator PEC-II
3. Mr. Muhammad Haseeb Tariq Evaluator PEC-III
4. Mst.Farzana Raja Evaluator PEC-IV
5. Mst. Iqra Aftab Evaluator PEC-V
6. Mr. Muhammad Umar Latif Evaluator PEC-VI
7. Mst. Sidra Khalid Evaluator PEC-VII
8. Mst. Haleema Sharif Evaluator PEC-VIII
9. Mst. Najia Saleem Evaluator PEC-XI
10. Syed Ajwad Bukhari Evaluator PEC-XII
11. Mst. Mehwish Javed Khan Evaluator PEC-XIII
12. Mr. Muhammad Ahsan Hafiz Evaluator PEC-XIV

Case No. 1: Review of Formulation
Evaluator PEC-II
1. L-ornithine L-aspartate (5gm per10ml) injection/infusion
The formulation of ―L-ornithine L-aspartate (5gm per10ml) injection/infusion‖ was

deferred in recent meetings of Registration Board deferred for evidence of approval of applied
formulation in Reference Regulatory Authorities.
The reference of approval for said formulation now has been verified from ―Austrian
Agency for Health and Food Safety (AGES)‖ in the same strength and dosage form, which is a
reference regulatory authority as adopted by Registration Board. The details of product
registration are as follows:
● Brand Name: Hepa-Merz 5 g / 10 ml infusion solution concentrate
● Approval Number: Z.Nr.: 14964
● Pharmaceutical form: Concentrate for solution for infusion
● Composition: 1 ampoule of 10 ml contains 5 gm of Ornithine aspartate in
aqueous solution
● Owner of the Approval: Merz Pharma Austria GmbH, 17, 1110 Vienna
● Link for reference:
https://aspregister.basg.gv.at/aspregister/faces/aspregister.jspx?_afrLoop=80190785136710150&_afr
WindowMode=0&_adf.ctrl-state=14vs5iesd74 (Accessed on 04-05-2018)
Following cases have been deferred in various meetings of Registration Board and hereby
presented before the Board for consideration.
1. Name and address of manufacturer / Neutro pharma (Pvt.) Ltd. 9.5 km Sheikhupura Road
Applicant Lahore
Brand Name +Dosage Form+Strength NEUCURE 5g/10ml Infusion
Composition Each 10 ml contains:
L-ornithine L-aspartate………5g
Diary No. Date of R& I & fee Diary No:5272, 08/06/2017, Rs: 20,000/-
Pharmacological Group amino acid
Type of Form Form-5
Finished Product Specification Manufacturer‘s specifications
Pack size & Demanded Price 1‘s x 10ml /As Per SRO
Approval status of product in Not submitted by the firm
Reference Regulatory Authorities.
Me-too status Hepa-merz 5gm/10ml Infusion Concentrate by M/s
Brookes pharma (Reg#008633)
GMP status 03-05-17; Inspection of Additional Sections.
Panel recommends grant of additional sections.
Remarks of the Evaluator. ● Approval status of product in Reference
Regulatory Authorities not confirmed.
● Primary packaging material not confirmed from
● Applied pack size not confirmed from Reference
Regulatory Authorities.
Previous Decision 274th ● Deferred for evidence of approval of applied
formulation in Reference Regulatory Authorities.
Evaluation by PEC The firm has submitted the followitng reply.

In the light of above decision kindly note that
following product is health and OTC product that is not
under drug category that‘s why product is not available
in DRA website. Furthermore, please find the attached
herewith the evidence of International /Local
availability
● Hepa-merz 5gm/10ml by Merz Pharma GmbH
& Co. KGaA (Germany)
Decision of 276th meeting: Deferred for further deliberation.
Remarks of Evaluator: Firm has approved S.V.P section (Blow fill & sealing in LDPE)
Decision: Registration Board was apprised that applied formulation is available in glass
ampoules, both in Reference Regulatory Authorities and as generics approved by DRAP,
whereas, firm has applied for formulation in polyethylene ampoules.
Registration Board deliberated that difference in packaging material is not considered as
New Drug. So, Form 5D is not required and such applications shall be treated as Me-
too/Generic, while stability studies data, as decided by Registration Board in its 278 th
meeting, shall be submitted to establish shelf life with applied packaging material. Hence
Registration Board deferred the case for submission of stability studies data, as decided in
its 278th meeting
2. Name and address of manufacturer / M/s Medicraft Pharmaceuticals, 126-B, Industrial
Applicant estate Hayatabad Peshawar
Brand Name +Dosage Form + Strength Hepamed Infusion concentrate 5gm/ 10ml
Composition Each 10ml contains:-
L-Ornithine L-Aspartate……….…5gm
Diary No. Date of R& I & fee Dy. No. 4121, 28-12-2016; Rs.20,000/- (28-12-2016)
Pharmacological Group Amino Acid (Hepato Protective Lipotropic)
Type of Form Form-5
Finished product Specification In house specification
Pack size & Demanded Price 1x10ml, As per SRO
Approval status of product in Reference Not provided
Regulatory Authorities
Me-too status Hepa-Merz 5gm/ 10ml Infusion concentrate by
Brookes Pharma
GMP status Last GMP inspection was conducted on 30-01-2018 and
the report concludes:
―The firm MAY BE considered to be operative
in GOOD level of cGMP compliance. However, it was
an old facility, over space is limited, workload is heavy
due to heavy production of for local and export
purposes. The firm should plan for modification and/
or shifting to wide area in future. They were also
advised to arrange more fire-extinguishers and improve
emergency exits in the building. They should also
make a direct connection with fire brigade and install
smoke detectors.
Remarks of the Evaluator ● Inspection report includes many observations.
● The proposed drug couldn‘t be searched in
reference regulatory authorities.
th
Decision of 279 meeting: Deferred for for evidence of approval of applied formulation in
reference regulatory authorities/agencies which were declared/approved by the Registration
Board in its 275th meeting.
Decision: Approved with Innovator’s specifications.

Case No. 02 Registration applications for local manufacturing of (Human) drugs
a. New cases
Evaluator-PEC-VIII
3. Name and address of Manufacturer / M/s Sigma Pharma, International(Pvt)Ltd. Plot # E-50,
Applicant North Western industrial Zone, Bin Qasim, Karachi,
Brand Name+DosageForm+Strength Rispect tablet 1mg
Other proposed brand name:
Resident
Rostrum
Resido
Composition Each film coated tablet contains:
Risperidone….. 1mg
Diary No. Date of R&I & fee DyNo.3939; 24-05-2017; Rs. 20,000/-
Pharmacological Group Antipsychotic agent
Type of Form Form-5
Finished Product Specification USP Specifications
Pack Size & Demanded Price 1×10‘s, 2×10‘s, 3×10‘s, 5×10‘s, 3×6‘s; As per SRO
Approval status of product in Reference Risperdal 1 mg Tablets of Janssen-Cilag Ltd., UK
Regulatory Authorities (MHRA)
Me-too status Becalm 1 mg tablets of Maple pharmaceuticals
GMP status GMP inspection conducted on 15th September 2017
with conclusive remarks that firm is operating at
satisfactory level of GMP compliance.
Remarks of Evaluator
Decision:
Approved.
Fleelax
Melax
Relux
Type of Form Form-5
Pack Size & Demanded Price 1×10‘s, 2×10‘s, 3×10‘s, 5×10‘s, 3×6‘s, 2×6‘s; As per
SRO
Me-too status Becalm 2 mg tablets of Maple pharmaceuticals
Decision:
Approved.

Fleelax
Melax
Relux
Type of Form Form-5
Pack Size & Demanded Price 1×10‘s, 3×10‘s, 1×6‘s, 3×6‘s; As per SRO
Me-too status Resjun 3mg Tablets of Jupiter pharmaceuticals
Decision:
Approved.
Fleelax
Melax
Relux
Type of Form Form-5
Pack Size & Demanded Price 1×10‘s, 2×10‘s 3×10‘s, 1×6‘s, 3×6‘s; As per SRO
Me-too status Resjun 4mg Tablets of Jupiter pharmaceuticals
Decision:
Approved.
Brand Name +Dosage Form +Strength Quiq tablet 25mg
Quik
Stipen
Taipan
Quetiapine (as fumarate) ….. 25mg
Type of Form Form-5
Pack Size & Demanded Price 1×10‘s, 2×10‘s 3×10‘s; As per SRO
Approval status of product in Reference Approved in US-FDA
Me-too status Nubaquel 25mg tablet of Nabiqasim
Decision:
Approved.
Brand Name +Dosage Form +Strength Quiq tablet 100mg
Quik
Stipen
Taipan
Quetiapine (as fumarate) ….. 100mg
Type of Form Form-5
Pack Size & Demanded Price 1×10‘s, 2×10‘s 3×10‘s; As per SRO
Me-too status Nubaquel 100mg tablet of Nabiqasim
GMP status
Remarks of Evaluator GMP inspection conducted on 15th September 2017
Decision:
Approved.
Brand Name +Dosage Form +Strength Topera tablet 25mg
Tomet
Timet
Tempo
Topiramate ... 25mg
Pharmacological Group Antiepileptic agent
Type of Form Form-5
Pack Size & Demanded Price 1×10‘s, 2×10‘s, 3×10‘s, 6×10‘s,; As per SRO
Me-too status Erbro 25mg Tablet of M/s Shawan Pharmaceuticals
acceptable level of GMP compliance.

Decision:
Approved.
Tomet
Timet
Tempo
Topiramate ... 50mg
Type of Form Form-5
Pack Size & Demanded Price 1×10‘s, 2×10‘s, 3×10‘s, 6×10‘s,; As per SRO
Decision:
Approved.
Tomet
Timet
Tempo
Topiramate ... 100mg
Type of Form Form-5
Pack Size & Demanded Price 1×10‘s, 3×10‘s, 6×10‘s,; As per SRO
Decision:
Approved.
Brand Name +Dosage Form +Strength Luve tablet 25mg
Livlaf
Levoli
Levoni
Composition Each tablet contains:
Levosulpiride ... 25mg
Type of Form Form-5
Finished Product Specification Manufacturer‘s Specification
Pack Size & Demanded Price 1×10‘s, 3×10‘s, 6×10‘s,; As per SRO
Approval status of product in Reference Approved in Italy
Me-too status Lopritac Tablets 25mg of M/s Lowitt Pharma.
Remarks of Evaluator .Applicant has claimed manufacturer‘s specifications
and applied formulation is not present in available USP
and BP.
Decision:
Approved with innovator’s specification.
Brand Name +Dosage Form +Strength Luve tablet 50 mg
Livlaf
Levoli
Levoni
Type of Form Form-5
Pack Size & Demanded Price 1×10‘s, 2×10‘s; As per SRO
Remarks of Evaluator Applicant has claimed manufacturer‘s specifications and
applied formulation is not present in available USP and
BP.
Decision:
Brand Name +Dosage Form +Strength Luve tablet 100mg
Livlaf
Levoli
Levoni
Type of Form Form-5

Pack Size & Demanded Price 1×10‘s, 2×10‘s; As per SRO
Remarks of Evaluator Applicant has claimed manufacturer‘s specifications and
applied formulation is not present in available USP and
BP.
Decision:
Brand Name +Dosage Form +Strength Lamot tablet 25mg
Lamsin
Lamgin
Trigone
Lamotrigine ... 25mg
Type of Form Form-5
Finished Product Specification USP Specification
Pack Size & Demanded Price 3×10‘s; As per SRO
Me-too status Sportin 25mg Tablets of Fassgen Pharmaceuticals,
Remarks of Evaluator Approved in US-FDA with Box Warning:
Cases of life-threatening serious rashes, including
Stevens-Johnson syndrome and toxic epidermal
necrolysis, and/or rash-related death have been caused
by lamotrigine. The rate of serious rash is greater in
pediatric patients than in adults. Additional factors that
may increase the risk of rash include: coadministration
with valproate.
Decision:
Approved.
Livlaf
Levoli
Levoni
Type of Form Form-5
Approval status of product in Reference Approved in MHRA
Decision:
Approved.
Livlaf
Levoli
Levoni
Type of Form Form-5
Remarks of Evaluator Approved in US-FDA with Box Warning:
Cases of life-threatening serious rashes, including
Stevens-Johnson syndrome and toxic epidermal
necrolysis, and/or rash-related death have been caused
by lamotrigine. The rate of serious rash is greater in
pediatric patients than in adults. Additional factors that
may increase the risk of rash include: coadministration
with valproate.
Decision:
Approved.
18. Name and address of Manufacturer / M/s Scottmann Pharmaceuticals,
Applicant 5-D I-10/3 Industrial Area. Islamabad.
Brand Name +Dosage Form +Strength Metscot tablet 250mg

Metformin hydrochloride… 250mg
Pharmacological Group Blood glucose lowering agent (Biguanides)
Type of Form Form-5
Approval status of product in Reference Approved in TGA
Me-too status Diamet tablet 250mg of Nabiqasim(but film coated is
not confirm)
GMP status GMP inspection conducted on 14-09-2017 &21-09-
2017 with conclusive remarks that firm is operating at
very good level of GMP compliance.
Remarks of Evaluator Evidence of approval of applied formulation in
reference regulatory authorities/agencies.
Decision:
Approved.

Pharmacological Group Blood glucose lowering agent(Biguanides)
Type of Form Form-5
Me-too status Glucophage tablet 500mg of Merck
Decision:
Approved.

Type of Form Form-5
Me-too status Glucophage tablet 850mg of Merck
Decision:
Approved.

Type of Form Form-5

Me-too status Glucotech tablet 1000mg of Merck
Decision:
Approved.
22. Name and address of Manufacturer / M/s Saim Pharmaceuticals 217, Industrial triangle,
Applicant Kahuta Road, Islamabad
Brand Name +Dosage Form +Strength Sertex tablet 100mg

Sertraline (as hydrochloride)… 100mg
Pharmacological Group Antidepressant (SSRIs)
Type of Form Form-5
Me-too status ELLETTRA 100mg tablet of Wilshire
GMP status Panel inspection conducted on 16-02-18 recommends
renewal of DML by the way of formulation of tablet
section general and capsule section.
Remarks of Evaluator Approved in US-FDA with box warning:
Suicidal thoughts.
Decision:
Approved.
23. Name and address of Manufacturer / M/s Siam Pharmaceuticals 217, Industrial triangle,
Applicant Kahuta Road, Islamabad
Brand Name +Dosage Form +Strength Sertex tablet 50mg

Sertraline (as hydrochloride)… 50mg
Pharmacological Group Antidepressant (SSRIs)
Type of Form Form-5
Me-too status ELLETTRA 50mg tablet of Wilshire
GMP status Panel inspection conducted on 16-02-18 recommends
renewal of DML by the way of formulation of tablet
section general and capsule section.
Remarks of Evaluator Approved in US-FDA with box warning:
Suicidal thoughts.
Decision:

Approved.
24. Name and address of Manufacturer / M/s Rock Pharmaceuticals Laboratories (Pvt) Ltd. 134-
Applicant B & 135-B Nowshera Industrial Estate, Risalpur.
Brand Name +Dosage Form +Strength Xocip 750mg tablets
Ciprofloxacin (as hydrochloride monohydrate)…750mg
Pharmacological Group Antibiotic
Type of Form Form-5
Pack Size & Demanded Price 10‘s; As per SRO
Me-too status Ciprobid tablet 750mg of Nova pharmaceuticals
GMP status GMP inspection conducted on 07-12-2017 does not
have conclusive remarks.
Decision:
Registration Board referred the case to QA & LT Division to conduct GMP inspection of Firm on
priority.
Brand Name +Dosage Form +Strength Tiglit-M tablet 50/500
Sitagliptin(as phosphate monohydrate)…50mg
Metformin hydrochloride…..500mg
Pharmacological Group Dipeptidyl peptidase-4 inhibitor/Biguanide
Type of Form Form-5
Finished Product Specification Manufacturer‘s Specifications
Me-too status Glusimet 50mg/500mg Tablet of Opal Lab. Karachi.
Decision:
priority.
Brand Name +Dosage Form +Strength Tiglit-M tablet 50/1000
Sitagliptin(as phosphate monohydrate)…50mg
Metformin hydrochloride…..1000mg
Type of Form Form-5
Me-too status Glusimet 50mg/1000mg Tablet of Opal Lab. Karachi.

Decision:
Registration Board referred the case to QA & LT Division to conduct GMP inspection of firm on
priority.
Brand Name +Dosage Form +Strength Robifen tablet 100mg
Flurbiprofen…100mg
Type of Form Form-5
Approval status of product in Reference Approved in ANSM
Me-too status Biofen 100mg Tablet of Mission Pharma
Remarks of Evaluator Pvc/alu in ansm.
Decision:
priority.
Brand Name +Dosage Form +Strength Robecide 200mg/5ml suspension
Composition Each 5ml contains:
Metronidazole(as benzoate)…200mg
Diary No. Date of R&I & fee DyNo.5030or 5630; 07-06-2017; Rs. 20,000/-
Pharmacological Group Amoebicide
Type of Form Form-5
Pack Size & Demanded Price 1‘s (60ml); As per SRO
Me-too status Mogel 200mg Suspension of M/s Metro Pharma
Decision:
priority.
Evaluator-PEC-II
29. Name and address of manufacturer / M/s Jenner Pharmaceuticals (Pvt) Ltd, 28-KM Lahore
Applicant Sharaqpur Road, District Sheikhupura.
Brand Name +Dosage Form + Strength Co-Apraise tablets 300/12.5mg

Irbesartan …. 300mg
Hydrochlorthiazide ……. 12.5mg
Diary No. Date of R& I & fee Dy. No.920; 30-09-2015; Rs.20,000/- (29-09-2015)

Pharmacological Group Angiotensin-Ii Antagonists and Diuretics
Type of Form Form-5
Finished product Specification USP
Pack size & Demanded Price 28‘s;As per SRO
Approval status of product in Reference Approved by MHRA of UK
Me-too status Irbest Plus Tablets of M/s. Highnoon Laboratories,
(Reg.#077111)
GMP status Last GMP inspection conducted on 06.11.2017 and the
report concludes that overall the condition of firm is
satisfactory.
Remarks of the Evaluator.
Decision: Approved
Brand Name +Dosage Form + Strength Febuxo tablets 80mg

Febuxostat …… 80mg
Pharmacological Group Anti-Gout
Type of Form Form-5
Finished product Specification Manufacturer‘s Specifications
Approval status of product in Reference Approved by USFDA
Me-too status Urigo 80mg Tablet of M/s. Sami Karachi, (Reg.#076667)
satisfactory.
Decision: Approved with Innovator’s specifications
Brand Name +Dosage Form + Strength Nufac tablets 135mg

Mebeverine hydrochloride …… 135 mg
Pharmacological Group Anticholinergics
Type of Form Form-5
Me-too status Cisper 135mg tablet of M/s. Cibex Karachi,
(Reg.#074878)
satisfactory.

Decision: Approved with BP specifications
32. Name and address of manufacturer / M/s Himont Pharma Pvt Ltd, 17-Km Ferozpur Road,
Applicant Lahore.
Brand Name +Dosage Form + Strength Cardiset Tablet 12.5mg

Carvedilol ............... 12.5mg
Pharmacological Group Alpha and beta blocking agents.
Type of Form Form-5
Pack size & Demanded Price Rs. 130/- per 10‘s
Me-too status Arvid 12.5mg Tablets by M/s Global Pharmaceuticals
(Reg#035969)
GMP status Last inspection report conducted on 14-04-2017 & 11-5-
2017. Panel recommends the grant of renewal of DML
Decision: Approved
33. Name and address of manufacturer / M/s Irza Pharma (Pvt) Ltd, Lahore
Applicant
Brand Name +Dosage Form + Strength Irzadole 50mg Tablet

Tramadol HCl...................50mg
Diary No. Date of R& I & fee Dy. No.323, 19-11-2014 (Duplicate file); Rs.8,000/-
(10-11-2008) Photocopy
Rs. 12,000/- (19-11-2014)
Pharmacological Group Opiate analogue
Type of Form Form-5
Pack size & Demanded Price Rs. 105/- per 10‘s
Approval status of product in Reference Ultram tablet of M/s JANSSEN PHARMS, approved by
Regulatory Authorities. USFDA.
Me-too status Tramed- Tablets by M/s Platinum Pharmaceuticals (Pvt)
Ltd, (Reg#024457)
GMP status The last GMP inspection was conducted on 12-05-2017
and the report concludes renewal of DML and grant of
additional section namely:
i. Capsule (Cephalosporin)
ii. Dry powder suspension (Cephalosporin).
Decision: Approved. Reference will be sent to Budget & Accounts Division for verification of
challan and Board authorized its Chairman for the issuance of registration letter.
34. Name and address of manufacturer / M/s Irza Pharma (Pvt) Ltd, Lahore
Applicant
Brand Name +Dosage Form + Strength Irzadol 50mg Capsule
Composition Each capsule contain:

Tramadol HCl......50mg
Diary No. Date of R& I & fee Dy. No.322, 19-11-2014 (Duplicate file); Rs.8,000/-
(10-11-2008) Photocopy
Rs. 12,000/- (19-11-2014)
Pharmacological Group Opiate analogue
Type of Form Form-5
Finished product Specification BP
Pack size & Demanded Price Rs. 125/- per 1 x 10‘s
Rs. 525/- per 5 x 10‘s
Approval status of product in Reference Tramadol 50mg capsule by Milpharm Ltd, approved by
Regulatory Authorities. MHRA of UK.
Me-too status Tramal capsule 50mg by Impex Plus Karachi
(Reg#010170)
GMP status The last GMP inspection was conducted on 12-05-2017
and the report concludes renewal of DML and grant of
additional section namely:
i. Capsule (Cephalosporin)
ii. Dry powder suspension (Cephalosporin).
35. Name and address of manufacturer / M/s Wimits Pharmaceuticals (Pvt) Ltd, Plot No. 129
Applicant Sundar Industrial Estate Raiwind Road, Lahore
Brand Name +Dosage Form + Strength Epicarb suspension

Carbamazepine.............100mg
Diary No. Date of R& I & fee Dy. No. 2086, 26-10-2016, Rs. 20,000/- (26-10-2016)
Pharmacological Group Anti-epileptic
Type of Form Form-5
Pack size & Demanded Price 120ml; As per SRO
Me-too status Neu-Nil Suspension by M/s Leema Chemi Pharma (Pvt)
Ltd (Reg#020313)
GMP status Copy of GMP certificate issued by Additional Director,
DRAP Lahore, based upon evaluation conducted on 03-
11-2017
Decision: Approved
36. Name and address of manufacturer / M/s Wimits Pharmaceuticals (Pvt) Ltd, Plot No. 129
Applicant Sundar Industrial Estate Raiwind Road, Lahore
Brand Name +Dosage Form + Strength Epicarb 200mg Tablet

Carbamazepine.............200mg
Diary No. Date of R& I & fee Dy. No. 1714 18-10-2016, Rs. 20,000/- (18-10-2016)
Type of Form Form-5
Pack size & Demanded Price 5 x 10‘s; As per SRO

Me-too status Carbawel 200 mg Tablets by M/s Welmark
Pharmaceuticals (Reg#077462)
GMP status Copy of GMP certificate issued by Additional Director,
DRAP Lahore, based upon evaluation conducted on 03-
11-2017
Decision: Approved
37. Name and address of manufacturer / M/s Bajwa Pahrmaceuticals (Pvt) Ltd, 36 K.M, G.T
Applicant Road, Khori Muridke (Sheikhupura)
Brand Name +Dosage Form + Strength Baligno 2.0% Injection
Composition Each ml contains:

Lignocaine HCl ...............20mg
Diary No. Date of R& I & fee Dy. No. 340, 22-08-2016; Rs. 20,000/- (22-08-2016)
Pharmacological Group Local anaesthetic
Type of Form Form-5
Pack size & Demanded Price 2ml x 100‘s; As per PRC
Me-too status Lignocaine Injection 2% by M/s Elite Pharma lahore,
(Reg#026236)
GMP status Last inspection report conducted on 21-02-2018 with
following conclusion:
―Overall hygienic condition of firm was satisfactory at
time of inspection. They were advised to improve further
their documentation as mentioned in above. They
agreed.‖
Decision: Approved
Brand Name +Dosage Form + Strength Bopamin Injection

Dopamine HCl........40mg
Type of Form Form-5
Pack size & Demanded Price 5ml x 1 ampoule
5ml x 10 ampoules
5ml x 50 ampoules As per SRO
5ml x 100 ampoules
Me-too status DOPAMINE 200MG INJECTION by M/s LC&PW,
(Reg#005935)

agreed.‖
Decision: Approved
Brand Name +Dosage Form + Strength Water for injection
Composition Each ampoule contains:

Water for injection........10ml
Pharmacological Group Diluent
Type of Form Form-5
Pack size & Demanded Price 10ml x 100 ampoules; As per PRC
Me-too status Water for Injection of M/s Vision Pharma (Reg.#
032340)
agreed.‖
Decision: Approved.
Brand Name +Dosage Form + Strength Pivacaine-SP 0.5% Heavy Injection
Bupivacine Hydrochloride......20mg
Glucose monohydrate ..........320mg
Type of Form Form-5
Pack size & Demanded Price 4ml x 05 ampoules
4ml x 10 ampoules; As per PRC
Approval status of product in Reference Marcain Heavy, 0.5% solution for injection of M/s Aspen
Regulatory Authorities. Pharma Trading Limited pproved by MHRA of UK
Me-too status Sensocain Spinal 0.5% Injection of Brookes
Pharmaceuticals Laboratories (Reg.# 057745)
agreed.‖
Remarks of the Evaluator. ● In reference product Glucose monohydrate is

mentioned as excipient.
●
Firm has proposed following alternate brand
names:
i. B-vacaine-SP 0.5% Heavy Injection
ii. Verticaine-SP 0.5% Heavy Injection
Decision: Deferred for clarification of role of Glucose monohydrate in the applied formulation.
Brand Name +Dosage Form + Strength Falfin Injection

Nalbuphine HCl.........10mg
Pharmacological Group Analgesic
Type of Form Form-5
Finished product Specification Manufacturer specifications
Pack size & Demanded Price 1ml x 1‘s; Rs. 45/-
1ml x 05 ampoules; Rs. 225/-
Me-too status Nalbufin Injection of M/s Mass Pharma (Pvt) Ltd, 17
KM, Ferozepur Road, Lahore (Reg.# 025543)
agreed.‖
Remarks of the Evaluator. ● No USP or BP monograph is available for
applied formulation
● Firm has proposed following alternate brand
names:
i. Balfin Injection
ii. Nalfin Injection
Brand Name +Dosage Form + Strength Trocuronium 1.0% Injection

Rocuronium Bromide .........10mg
Pharmacological Group Muscle relaxant agent
Type of Form Form-5
Pack size & Demanded Price 5ml x 5 ampoules
5ml x 25 ampoules
As per PRC
Me-too status Esmeron Injection 50mg of M/s Organon Pakistan (Pvt)
(Reg.#021154)
agreed.‖
Remarks of the Evaluator. ● No USP or BP monograph is available for
applied formulation
● Firm has proposed following alternate brand
names:
i. Baj-Cronium Injection
ii. R-Cronium Injection
43. Name and address of manufacturer / M/s Wenovo Pharmaceuticals, Plot No. 31&32, Punjab
Applicant Small Industrial Estate, Taxila, Rawalpindi. contract
manufacturing by M/s Dyson Research Laboratories
Pvt, 28-km, Ferozepur Road, Lahore.
Brand Name +Dosage Form + Strength Progest Tablets 10mg

Dydrogesterone………….10mg
Diary No. Date of R& I & fee Dy. No.822, 15-05-2015, Rs. 50,000/- (15-05-2015)
Pharmacological Group Progestogen
Type of Form Form-5
Pack size & Demanded Price 20‘s; As per SRO
Approval status of product in Reference Duphaston by BGP Products (Swissmedic Approved)
Me-too status Duphaston by Abbott (Reg. No. 006654)
GMP status Last inspection report of M/s Dyson Research
Laboratories Pvt, 28-km, Ferozepur Road, Lahore
conducted on 1-8-2017 wherein panel recommended
issuance of GMP certificate
Remarks of the Evaluator. M/s Dyson Research Laboratories has approved tablet
(Hormone) section.
Decision: Deferred for further deliberation upon Cis / Trans isomer of Dydrogesteron.
44. Name and address of manufacturer / M/s GT Pharma (Pvt) Ltd, Plot No. 713, Punjab
Applicant Industrial Estate, Sunder Industrial Estate, Lahore.
Brand Name +Dosage Form + Strength Gapre 50mg Capsule
Composition Each capsule contains:

Pregabalin ................50mg
Pharmacological Group Anti epileptic
Type of Form Form-5
Finished product Specification Manufacturer specification
Approval status of product in Reference Lyrica of (USFDA approved)
Me-too status Gabica Capsule by M/s Getz Pharma
GMP status
Remarks of the Evaluator. Latest GMP inspection report conducted on 08-08-2017
and report concludes GMP compliance status
Decision: Approved with innovator’s specifications
45. Name and address of manufacturer / M/s Elite Pharma Pvt Ltd., P.D.H. Street 9.5 km
Applicant Sheikhupura Road, Lahore.

Brand Name +Dosage Form + Strength Neloxalite injection

Naloxone HCl ….. 0.4mg
Diary No. Date of R & I & fee Dy. No. 1600, 17-10-2016, Rs. 20,000/- (17-10-2016)
Pharmacological Group Opioid antagonist
Type of Form Form-5
Pack size & Demanded Price 1ml x 10‘s; Rs. 115 per ampoule
Me-too status NALOXONE INJECTION 0.4MG of M/s REHMAN
MEDICINES CO (Reg.# 019587)
the report concludes:
―It is advised to overcome the shortcomings
and submit the compliance report to the competent
authorities so that the inspection could be conducted
accordingly.‖
Remarks of the Evaluator. In 279th meeting of RB the cases of M/s Elite Pharma
were deferred for updated status of GMP of the firm form
QA & LT division as inspection report submitted by firm
does not conclude GMP compliant status
Firm has proposed following alternate brand names:
i. Neloxalite
ii. Nelox
iii. Nelolite
Decision: Deferred for updated status of GMP of the firm form QA & LT division as inspection
report submitted by firm does not conclude GMP compliant status
46. Name and address of manufacturer / M/s Linta Pharmaceuticals (Pvt) Ltd, Plot No.3 Street
Applicant No.S-5, RCCI, Rawat Rawalpindi.
Brand Name +Dosage Form + Strength Moscolin 4mg Capsules
Composition Each hard gelatin capsule contains:

Thiocolchicoside…………..4mg
Pharmacological Group Muscle relaxant
Type of Form Form-5
Finished product Specification Manufacturer Specification
Pack size & Demanded Price As per DRAP policy
Approval status of product in Reference ANSM Approved
Me-too status Thiolax Capsule 4 mg by M/s SJ&G Fazul Ellahie
(Reg.#055404)
the report concludes firm may be issued GMP certificate.
Remarks of the Evaluator. ● No USP or BP monograph is available for applied
formulation
● Firm has proposed following alternate brand names:
i. Thioc
ii. Macthio
iii. Colchi
No.S-5, RCCI, Rawat Rawalpindi.
Applicant
Brand Name +Dosage Form + Strength Ciproxil 250mg Tablet
Composition Each film coated tablet contain:

Ciprofloxacim as Hydrochloride……………..250mg
Pharmacological Group Fluoroquinolones, Antibiotic
Type of Form Form-5
Finished product Specification USP Specifications
Pack size & Demanded Price Unit price & Pack size as per DRAP Policy
Approval status of product in Reference Ciprofloxacin tablets 250mg of M/s Special Concept
Regulatory Authorities. Development (UK MHRA Approved)
Me-too status Axcin Tablets 250mg of M/s Novartis Pharmaceuticals
Remarks of the Evaluator. ● Firm has proposed following alternate brand names:
i. Ciprom
ii. Ziprox
iii. Cipmax
iv. Siprion
Decision: Approved with change of brand name
Brand Name +Dosage Form + Strength Ciproxil 500mg Tablet
Ciprofloxacim as Hydrochloride……………..500mg
Type of Form Form-5
i. Ciprom
ii. Ziprox
iii. Cipmax
iv. Siprion
Brand Name +Dosage Form + Strength L-Quin 500mg Tablet

Levofloxacin as Hemihydrate …………..500mg
Type of Form Form-5

Approval status of product in Reference Levofloxacin Tablets 500mg of M/s Actavis Group
Regulatory Authorities. United Kingdom (MHRA Approved)
Me-too status Leflox Tablets 500mg of M/s Getz Pharma
i. Quino
ii. Levop
iii. L-Flox
Brand Name +Dosage Form + Strength L-Quin 250mg Tablet

Levofloxacin as Hemihydrate …………..250mg
Type of Form Form-5
Approval status of product in Reference Levofloxacin Tablets 250mg of M/s Actavis Group
Regulatory Authorities. United Kingdom (MHRA Approved)
Me-too status Leflox Tablets 250mg of M/s Getz Pharma
i. Quino
ii. Levop
iii. L-Flox
Brand Name +Dosage Form + Strength Blin 100mg Capsules

Pregabalin……………..100mg
Pharmacological Group Antiepileptic
Type of Form Form-5
Finished product Specification Manufacturer‘s specification
Approval status of product in Reference Lyrica (USFDA approved)
Me-too status Zeegap 100mg capsules by M/s Hilton Pharma
i. Preg
ii. Wonder

Brand Name +Dosage Form + Strength Blin 75mg Capsules

Pregabalin……………..75mg
Type of Form Form-5
i. Preg
ii. Wonder
Brand Name +Dosage Form + Strength Tem Capsules 0.4mg
Tamsulosin hydrochloride extended release pellets
0.2%w/w eq. to Tamsulosin
hydrochloride………….0.4mg
Source of pellets: M/s Vision pharmaceuticals
Pharmacological Group Alpha-adrenoceptor antagonist
Type of Form Form-5
Me-too status Uroflo capsule by Novartis
i. Solin
ii. Lint
Decision: Approved
Brand Name +Dosage Form + Strength Irop 100mg capsule

Iron polysaccharide eq. to elemental
Iron…………………..100mg
Pharmacological Group Iron Supplement/Hematinic
Type of Form Form-5
Approval status of product in Reference IFEREX 150 - polysaccharide-iron complex capsule by

Regulatory Authorities. M/s Nnodum Pharmaceuticals (DailyMed)
Me-too status Gilcure 100 mg Capsules of M/s Gillman Pharmaceuticals,
(Reg.#078484)
Remarks of the Evaluator. ● Reference product is available in 150mg strength
whereas firm has applied for 100mg capsule
● Firm has proposed following alternate brand names:
i. Irox
ii. Irofit
Decision: Registration Board approved as per innovator’s specification, since oral iron
preparations are not considered as OTC preparations by reference regulatory authorities
55. Name and address of manufacturer / M/s Global Pahrmaceuticals, Islamabad contract
Applicant manufacturing by M/sVision Pharmaceuticals,
Islamabad
Brand Name +Dosage Form + Strength Glonate Injection 100mg
Composition Each vial contains:

Hydrocortisone sodium succinate eq. to
Hydrocortisone…………..100mg
Diary No. Date of R& I & fee Dy. No. 167, 03-11-2016, Rs. 20,000/- (02-11-2016) Rs.
30,000/- (10-11-2016)
Pharmacological Group Glucocorticoid
Type of Form Form-5
Pack size & Demanded Price 1 x 1‘s; as per SRO
Approval status of product in Reference SOLU-CORTEF ACT-O-VIAL 100mg powder for
Regulatory Authorities. injection and diluent by M/s Pfizer Australia Pty Ltd
(TGA Approved)
Me-too status Cortizone 100mg Injection by M/s Vision
Pharmaceuticals (Reg# 081898)
GMP status Copy of GMP certificate of M/s Vision Pharmaceuticals
valid upto 25-01-2019
Remarks of the Evaluator. ● M/s Vision Pharmaceuticals has approved facility for
―Dry Powder injection (Steroids) section.
56. Name and address of manufacturer / M/s Global Pahrmaceuticals, Islamabad contract
Applicant manufacturing by M/sVision Pharmaceuticals,
Islamabad
Brand Name +Dosage Form + Strength Glonate Injection 500mg
Hydrocortisone sodium succinate eq. to
Hydrocortisone…………..500mg
30,000/- (10-11-2016)
Pharmacological Group Glucocorticoid
Type of Form Form-5
Pack size & Demanded Price 1 x 1‘s; as per SRO
Approval status of product in Reference SOLU-CORTEF ACT-O-VIAL 500mg powder for
Regulatory Authorities. injection and diluent by M/s Pfizer Australia Pty Ltd
(TGA Approved)
Me-too status Cortizone 500mg Injection by M/s Vision
Pharmaceuticals (Reg# 081900)

GMP status Copy of GMP certificate of M/s Vision Pharmaceuticals
Remarks of the Evaluator. ● M/s Vision Pharmaceuticals has approved facility for
―Dry Powder injection (Steroids) section.
57. Name and address of manufacturer / M/s CCL Pharmaceuticals (Pvt) Ltd, Lahore
Applicant
Brand Name +Dosage Form + Strength Rispa Oral Solution 1mg/ml

Risperidone .............1mg
12,000/- (17-08-2015)
Pharmacological Group Antipsychotic
Type of Form Form-5
Pack size & Demanded Price 30ml x 1‘s; as per brand leader
Me-too status Risperdal Oral Solution by M/s Johnson & Johnson Ltd
Karachi. (Reg.# 027396)
GMP status Last GMP inspection conducted on 08-03-2017, & 31-03-
2017 and the report concludes that firm is operating at
satisfactory level of compliance of GMP.
Decision: Registration Board referred the case to QA & LT Division to conduct GMP inspection of
Firm on priority.
58. Name and address of manufacturer / M/s Fresh Pharmaceuticals, Plot # 7, street # S-6,
Applicant National industrial zone, RRCI, Rawat, Islamabad
Brand Name +Dosage Form + Strength Ntbact 250mg tablet

Ciprofloxacin as hydrochloride …….. 250mg
Type of Form Form-5
Pack size & Demanded Price As per SRO
GMP status Last GMP Inspection dated 9-5 17 with conclusive
remarks of Good cGMP compliance.
i. Ciprolox
ii. Floquin
Decision: Approved
59. Name and address of manufacturer / M/s EG Pharmaceuticals, Islamabad
Applicant
Brand Name +Dosage Form + Strength Dirin 50mg Capsule

Diacerein …….. 50mg

Pharmacological Group Other antiinflammatory and antirheumatic agents,
nonsteroids
Type of Form Form-5
Approval status of product in Reference Diacerein 50 mg hard capsule by M/s BIOGARAN
Regulatory Authorities. (ANSM France Approved)
Me-too status Dibro 50mg Capsules by M/s Winbrain Research
Laboratories (Reg#071639)
GMP status Last GMP inspection of EG Pharma conducted on 22-06-
2017 the report concludes that overall firm is operating at
reasonable level of compliance with GMP.
Decision: Registration Board approved the applied formulation only for the following clinical
indication. “Treatment of symptoms of osteoarthritis of the hip or knee joint.”
60. Name and address of manufacturer / M/s EG Pharmaceuticals, Islamabad
Applicant
Brand Name +Dosage Form + Strength Abalin 75mg Capsule

Pregabalin …….. 75mg
Diary No. Date of R& I & fee Dy. No. 23531 (Duplicate dossier), 19-11-208-12-2017,
Rs. 20,000/- (20-06-2104) Photocopy
Type of Form Form-5 (Duplicate dossier)
Pack size & Demanded Price As per DRAP policy
GMP status Last GMP inspection of EG Pharma conducted on 22-06-
2017 the report concludes that overall firm is operating at
reasonable level of compliance with GMP.
61. Name and address of manufacturer / M/s Alza Pharmaceuticals, Jhelum Road, Rawalpindi.
Applicant
Brand Name +Dosage Form + Strength Hylo care Forte ophthalmic solution

Sodium hyaluronate …. 20mg
Pharmacological Group Ocular Lubricant
Type of Form Form-5
Pack size & Demanded Price As recommended by PRC
Approval status of product in Reference Approved by TGA as medical devices
Me-too status Hylo of M/s Helix Pharma (Reg.#067031)
GMP status Copy of GMP certificate valid upto 06-07-2018
Remarks of the Evaluator. ● Firm has approved Steroid eye drop section.
● Firm has submitted revised composition and master
formulation on 05-04-2015 as under:
―Each ml contains: Sodium hyaluronate …. 2 mg‖
●
Revised formulation submitted is as per me-too
reference.
Decision: Deferred for submission of fee for revision of formulation.
62. Name and address of manufacturer / M/s Alza Pharmaceuticals, Jhelum Road, Rawalpindi.
Applicant
Brand Name +Dosage Form + Strength Hylo care ophthalmic solution

Sodium hyaluronate …. 18mg
Type of Form Form-5
Pack size & Demanded Price As recommended by PRC
Approval status of product in Reference Not verifiable
Me-too status Hyalosan 0.18 % of M/s Sante (Reg.#037900)
GMP status Copy of GMP certificate valid upto 06-07-2018
Remarks of the Evaluator. ● Firm has approved Steroid eye drop section.
● Firm has submitted revised composition and master
formulation on 05-04-2015 as under:
―Each ml contains: Sodium hyaluronate …. 1mg
● Me too is not verifiable for revised composition.
● Fee has not been submitted for revision of
formulation/.
Decision: Deferred for following:
● Evidence of applied formulation/drug already approved by DRAP (generic / me-too status)
alongwith registration number, brand name and name of firm.
● Submission of fee for revision of formulation.
Evaluator-XI
63. Name and address of manufacturer / M/s Wilson’s Pharmaceuticals, 387-388, I-9, Industrial
Applicant Area, Islamabad.
Brand Name +Dosage Form + Strength Talergin-C 5% syrup
Carbocisteine…..................250mg
Pharmacological Group Mucolytic agent
Type of Form Form-5
Finished product Specifications Manufacturer‘s specifications
Pack size & Demanded Price 60ml, 90ml, 120ml; As per SRO
Approval status of product in Reference Mucodyne Oral solution of M/s Sanofi Aventis (MHRA
Regulatory Authorities Approved)
Me-too status (with strength and dosage Rhinathiol 5% for adults of M/s Sanofi Aventis
form)
GMP status Last inspection report conducted on 24-01-2018
concluding a very good level of GMP compliance.
Remarks of the Evaluator
Decision:Approved with innovator’s specification.
64. Name and address of manufacturer / M/s Wilson’s Pharmaceuticals, 387-388, I-9, Industrial
Applicant Area, Islamabad.
Brand Name +Dosage Form + Strength Talergin-C 375mg capsules

Carbocisteine…..................375mg
Pharmacological Group Mucolytic agent
Type of Form Form-5
Pack size & Demanded Price 10‘s, 20‘s and 30‘s; As per SRO
Approval status of product in Reference Mucodyne 375mg capsules of M/s Sanofi Aventis (
Regulatory Authorities (MHRA Approved)
Me-too status (with strength and dosage Rhinathiol 375mg capsules of M/s Sanofi Aventis
form)
concluding a very good level of GMP compliance.
65. Name and address of manufacturer / M/s. Genome Pharmaceuticals (Pvt.) Ltd., Plot # 16/I-
Applicant Phase IV, Industrial Estate, Hattar.
Brand Name +Dosage Form + Strength Urocyst 100mg tablet
Phenazopyridine hydrochloride.…………100mg
Pharmacological Group Urinary tract analgesic
Type of Form Form-5
Finished product Specifications USP
Pack size & Demanded Price As per SRO; As per PRC
Approval status of product in Reference Could not be confirmed
Me-too status (with strength and dosage Uropyrine 100mg tablet of M/s Ontech Corporation
form)
concluding good level of GMP compliance.
Remarks of the Evaluator Current status of formulation in Health Canada:
● Dormant
● Cancelled post marketing
Dormant: refers to an active drug identification number
that was previously marketed in Canada but for which the
manufacturer has suspended sale for period of at least 12
months.
Cancelled Post-Market: refers to a drug identification
number that is cancelled further to the discontinuation of
the sale by the manufacturer pursuant to Section
C.01.014.6 (1) (a) of the Regulations.
● Last GMP inspection report is not within last one
year.
Decision:Deferred for evidence of approval of applied formulation in reference regulatory
authorities/agencies as adopted by Registration Board in its 275th meeting and Registration Board
also referred the case to QA & LT Division to conduct GMP inspection of Firm on priority.
66. Name and address of manufacturer M/s Welwrd Pharmaceuticals, Plot No.3, Block A, Phase
/ Applicant I-II, Industrial Estate Hattar.
Brand Name +Dosage Form + Strength Esowel 40mg sachet
Composition Each sachet contains:
Esomeprazole magnesium enteric coated pellets 22.5%
equivalent to esomeprazole…...….40mg
Source of pellets: M/s Vision pharmaceuticals, Plot No. 22-23,
Industrial Triangle, Kahuta Road, Islamabad.

Pharmacological Group Proton pump inhibitor
Type of Form Form-5
Pack size & Demanded Price 10‘s; As per policy of MoH
Approval status of product in NEXIUM For Delayed-Release Oral Suspension 40mg (USFDA
Reference Regulatory Authorities approved)
Me-too status (with strength and Somezol 40mg Sachet of M/s Bosch Karachi (081612)
dosage form)
GMP status Last GMP inspection conducted on 14-06-2017 and the
report concludes that overall the firm is GMP compliant.
67. Name and address of manufacturer M/s Caraway Pharmaceuticals, Plot No. 12, Street N-3,
/ Applicant National Industrial Zone, Rawat, Islamabad.
Brand Name +Dosage Form + Strength Caraline 600mg/300ml infusion
Linezolid…....….2mg
Diary No. Date of R& I & fee Dy.No.1424;(13-10-2016);Rs.20,000/-(13-10-2016)
Pharmacological Group Antibacterial
Type of Form Form-5
Approval status of product in Zyvox (USFDA approved)
Reference Regulatory Authorities
Me-too status (with strength and Linzol 600mg/300ml Infusion of M/s Regal pharmaceuticals
dosage form)
GMP status Last GMP inspection conducted on 19-12-2017, and the report
concluded that the overall GMP compliance is Good as of
today.
Remarks of the Evaluator Registration Board approved the applied formulation with
innovator‘s specifications in the light of decision taken in 271 st
meeting, stated as under: ―In order to ensure, safety, efficacy
and quality of Linezolid infusion, Registration Board decided as
under;
i) All the Manufacturers of Linezolid Infusion shall follow the
packaging instructions of the innovator of the product i.e. M/s
Pfizer which has clearly mention the storage precautions in its
Product Information Leaflet (PIL). They will also make sure
that the solution is kept correctly in its box and foil wrapping in
order to protect from light.
Decision:Registration Board approved the applied formulation with innovator’s specifications in
the light of decision taken in 271st meeting, stated as under:
“In order to ensure, safety, efficacy and quality of Linezolid infusion, Registration Board
decided as under;
i) All the Manufacturers of Linezolid Infusion shall follow the packaging instructions of the
innovator of the product i.e M/s Pfizer which has clearly mention the storage precautions in its
Product Information Leaflet (PIL). They will also make sure that the solution is kept correctly
in its box and foil wrapping in order to protect from light.”
68. Name and address of manufacturer M/s Caraway Pharmaceuticals, Plot No. 12, Street N-3,
/ Applicant National Industrial Zone, Rawat, Islamabad.
Brand Name +Dosage Form + Strength Vildamin 50/1000mg tablets
Vildagliptin….........................….50mg
Metformin hydrochloride…....….1000mg
Diary No. Date of R& I & fee Dy.No.1422;(13-10-2016);Rs.20,000/-(13-10-2016)

Pharmacological Group Anti-diabetic
Type of Form Form-5
Pack size & Demanded Price 2x7‘s; As per SRO
Approval status of product in GALVUMET 50/1000 by Novartis (TGA Approved)
Me-too status (with strength and Galvus met by Novartis
dosage form)
GMP status Last GMP inspection conducted on 19-12-2017, and the report
concluded that the overall GMP compliance is Good as of
today.
Remarks of the Evaluator ➢ Shelf life of the innovator as approved by TGA is 18
months for PA/Al/PVC/Al-polyamide-aluminum foil
polyvinyl chloride/ aluminum foil, while the shelf life
approved by MHRA is PA/Alu/PVC/Alu-2 years
PCTFE/PVC/Alu- 18 months
Decision:Approved with Innovator‟s specification and shelf life of 18 months with packaging
material of PA/Al/PVC/Al -polyamide-aluminum foil-polyvinylchloride/aluminum foil.
69. Name and address of manufacturer / M/s Himont Pharmaceuticals (Pvt.) Ltd., 17-Km,
Applicant Ferozpur Road, Lahore.
Brand Name +Dosage Form + Strength Mirtasat tablet 45mg
Mirtazapine……….……45mg
Diary No. Date of R& I & fee Duplicate dossier; Rs.8,000/- (28-11-2011) duplicate
challan, Rs.12,000/- (10-02-2015) duplicate challan
verified from concerned bank
Pharmacological Group Antidepressants
Type of Form Form-5
Pack size & Demanded Price 20‘s; Rs.940/-
Approval status of product in Reference Remeron (USFDA approved)
Me-too status (with strength and dosage Charmfil 45mg tablet of M/s. Wilshire Laboratories
form)
GMP status Last Inspection for renewal of DML was conducted on
14-04-2017 and 11-05-2017 concluding renewal of all
sections except capsule (general) and Cephalosporin
(injectable, oral dry powder suspension and capsule)
sections.
70. Name and address of manufacturer / M/s Saydon Pharmaceutical Industries (Pvt.) Ltd., 77-
Applicant A, Hayatabad Industrial Estate, Peshawar.
Brand Name +Dosage Form + Strength Zulix tablet 100mg
Fluvoxamine maleate……….……100mg
Diary No. Date of R& I & fee Dy. No.46; 17-01-2011; Rs.8,000/- (17-01-2011),
Rs.12,000/- (07-01-2015)
Pharmacological Group Antidepressant
Type of Form Form-5
Finished product Specifications BP
Pack size & Demanded Price 10‘s and 30‘s; As per SRO
Approval status of product in Reference MHRA approved

Me-too status (with strength and dosage Faverin-100 tablets of M/s Highnoon Labs
form)
GMP status Last GMP inspection conducted on 13-02-2018
concluding acceptable level of compliance with GMP
guidelines.
Remarks of the Evaluator ● Rs.12,000/- fee challan for Injection Zulix 100mg is
attached instead of Zulix tablet 100mg.
Firm has now submitted ―the challan was filled
mistakenly‖.
Decision: Registration Board deferred the case for opinion of Legal Affairs Division regarding
consideration of submitted fee challan.
Brand Name +Dosage Form + Strength Zulix tablet 50mg
Fluvoxamine maleate……….……50mg
Rs.12,000/- (07-01-2015)
Type of Form Form-5
Pack size & Demanded Price 10‘s and 60‘s; As per SRO
Me-too status (with strength and dosage Faverin-50 tablets of M/s Highnoon Labs
form)
guidelines.
Remarks of the Evaluator ● Rs.12,000/- fee challan for Injection Zulix 50mg is
attached instead of Zulix tablet.
mistakenly‖.
Brand Name +Dosage Form + Strength C.C.DON C XR tablet 200mg
Composition Each film coated extended release tablet contains:
Quetiapine (as fumarate)……….……200mg
Rs.12,000/- (22-05-2015)
Type of Form Form-5
Finished product Specifications Innovator‘s specifications
Pack size & Demanded Price As per SRO; As per SRO
Me-too status (with strength and dosage Pine XR tablet 200mg of M/s. Werrick Pharmaceuticals
form)
guidelines.
Decision: Approved with change of brand name & with Innovators specifications.

Brand Name +Dosage Form + Strength C.C.DON D XR tablet 400mg
Rs.12,000/- (22-05-2015)
Type of Form Form-5
Me-too status (with strength and dosage Qusel XR 400mg tablet of M/s Hilton Pharma
form)
guidelines.
Brand Name +Dosage Form + Strength C.C.DON Plus XR tablet 300mg
Rs.12,000/- (22-05-2015)
Type of Form Form-5
Me-too status (with strength and dosage Quit XR 300 mg tablet of M/s Navegal Laboratories
form)
guidelines.
Brand Name +Dosage Form + Strength Stildon tablet 10mg
Zolpidem tartrate……….……10mg
Rs.12,000/- (22-05-2015)
Pharmacological Group Hypnotic
Type of Form Form-5
Me-too status (with strength and dosage Somnia 10mg tablets of M/s. Wilshire Laboratories
form)
guidelines.
Decision: Approved.
Brand Name +Dosage Form + Strength Zenil tablet 30mg
Phenobarbitone……….……30mg
Rs.12,000/- (22-05-2015)
Pharmacological Group Barbiturate
Type of Form Form-5
Me-too status (with strength and dosage Aleptal 30mg tablets of M/s Bloom pharmaceuticals
form)
guidelines.
Remarks of the Evaluator ● Overwriting on Rs.12,000/- fee challan
mistakenly‖.
Decision: Registration Board deferred for opinion of Legal Affairs Division regarding consideration
of submitted fee challan.
Brand Name +Dosage Form + Strength Neomine injection 2.5mg
Composition Each ml ampoule contains:
Neostigmine methylsulphate……….……2.5mg
Rs.12,000/- (22-05-2015)
Pharmacological Group Anticholinesterase
Type of Form Form-5
Me-too status (with strength and dosage Ostig 2.5mg/ml Injection of M/s Safe pharmaceuticals
form)
guidelines.
Decision: Approved.
Brand Name +Dosage Form + Strength Cetam XR capsule 75mg
Venlafaxine hydrochloride SR pellets 33% eq. to
venlafaxine……….……75mg
Source of pellets: M/s Vision Pharmaceuticals, Plot # 22-

23, Industrial Triangle, Kahuta Road, Islamabad.
Rs.12,000/- (22-05-2015)
Pharmacological Group Serotonin norepinephrine reuptake inhibitor (SNRI)
Type of Form Form-5
Me-too status (with strength and dosage Venflax XR 75mg capsule of M/s Regal Pharmaceuticals
form)

guidelines.
Remarks of the Evaluator ● Rs.12,000/- fee challan for Injection Cetam is
attached instead of Cetam capsule.
mistakenly‖.
Brand Name +Dosage Form + Strength Fluzen injection 25mg
Fluphenazine decanoate……….……25mg
Rs.12,000/- (22-05-2015)
Type of Form Form-5
Approval status of product in Reference USFDA, MHRA, TGA and Health Canada approved
Me-too status (with strength and dosage Saviget Injection 25mg/ml of M/s Cirin Pharma
form)
guidelines.
Remarks of the Evaluator ● Firm has initially applied for formulation containing
WFI as vehicle while the reference product in
USFDA, MHRA, TGA and Health Canada contains
sesame oil as vehicle.
● Firm has now submitted revised master formulation as
per reference product.
Decision: Approved.
Brand Name +Dosage Form + Strength Tablet Prozine CR 25mg
Composition Each enteric coated controlled release tablet contains:
Paroxetine (as hydrochloride hemihydrate).……25mg
Rs.12,000/- (22-05-2015)
Type of Form Form-5

Approval status of product in Reference USFDA approved
Me-too status (with strength and dosage Panox CR tablet 25mg of M/s Regal Pharmaceuticals
form)

guidelines.
Remarks of the Evaluator ● Rs.12,000/- fee challan for Injection Prozine is
attached instead of Prozine tablet.
mistakenly‖.
81. Name and address of manufacturer M/s. Demont Research Laboratories, 20-Km Lahore
/ Applicant Sharaqpur Road, Distt Sheikhupura.
Brand Name +Dosage Form + Epliron 50mg tablets
Strength
Eplerenone………50mg
Pharmacological Group Steroidal anti-mineralocorticoid, Aldosterone antagonists
Type of Form Form-5
Approval status of product in USFDA approved
Me-too status (with strength and Macrenone Tablet of M/s Macter International, Karachi
dosage form)
GMP status Last GMP inspection conducted on 23-02-2018 and 26-02-
2018 concluding satisfactory level of GMP compliance.
Remarks of the Evaluator ● In response to a query regarding evidence of steroid tablet
section approval granted by CLB the firm has submitted
reference of minutes for 257th DRB meeting‘s decision for
Alron tablet 25mg
“Product shall be manufactured in tablet (general) section as
the product doesn‟t possess any steroidal/hormonal activity.”
● Whereas the RB in its 269th meeting deferred similar
formulation for the confirmation of steroidal tablet section.
Decision: Deferred for confirmation of approved manufacturing facility for steroidal tablet section.
Brand Name +Dosage Form + Epliron 25mg tablets
Strength
Eplerenone………25mg
Pharmacological Group Steroidal anti-mineralocorticoid, Aldosterone antagonists
Type of Form Form-5

Me-too status (with strength and Macrenone Tablet of M/s Macter International, Karachi
dosage form)
Remarks of the Evaluator ● In response to a query regarding evidence of steroid tablet
section approval granted by CLB the firm has submitted
reference of minutes for 257th DRB meeting‘s decision for
Alron tablet 25mg
“Product shall be manufactured in tablet (general) section as
the product doesn‟t possess any steroidal/hormonal activity.”
● Whereas the RB in its 269th meeting deferred similar
formulation for the confirmation of steroidal tablet section.
Decision: Deferred for confirmation of manufacturing facility for steroidal tablet section.
Brand Name +Dosage Form + Strength Depnil 10mg tablets
Escitalopram (as oxalate)………10mg
Pharmacological Group Anti-depressant
Type of Form Form-5
Approval status of product in Cipralex Tablet
Reference Regulatory Authorities (MHRA Approved)
Me-too status (with strength and Morcet Tablet of M/s Searle

dosage form)
Decision: Approved with change of brand name.
Brand Name +Dosage Form + Strength Diaxin 20mg tablets
Piroxicam (as beta-cyclodextrin)………20mg
Pharmacological Group NSAID
Type of Form Form-5
Approval status of product in CYCLADOL 20 mg Tablet
Reference Regulatory Authorities ANSM France Approved
Me-too status (with strength and Ripax 20mg by Hilton

dosage form)
Decision: Approved with innovator’s specification.
85. Name and address of manufacturer M/s. Bio-Labs (Pvt.) Ltd., Plot No. 145 Industrial Triangle,
/ Applicant Kahuta Road, Islamabad.
Brand Name +Dosage Form + Strength Emtil 500mg tablets

Mycophenolate mofetil………500mg
Pharmacological Group Immunosuppressant
Type of Form Form-5
Pack size & Demanded Price 10‘s, 20‘s, 30‘s, 40‘s and 50‘s; As per PRC
Approval status of product in MHRA approved
Me-too status (with strength and Mygraf 500mg tablets of M/s Platinum
dosage form)
2017 concluding grant of cGMP certificate.
Decision: Registration Board approved registration of product in general manufacturing areas with
condition that manufacturer shall provide safety and protective measures for workers and
personnel which remain in direct contact or are involved in close handling of these drugs.
Brand Name +Dosage Form + Strength B-SET 8mg tablets
Ondansetron (as hydrochloride dihydrate)………8mg
Pharmacological Group Selective serotonin 5-HT3 receptor antagonist
Type of Form Form-5
Pack size & Demanded Price 10‘s, 20‘s, 30‘s and 40‘s; As per PRC
Me-too status (with strength and Zofran tablet of M/s GSK
dosage form)
Decision: Approved.
Brand Name +Dosage Form + Strength Nopan 8mg tablets
Lornoxicam………8mg
Type of Form Form-5
Pack size & Demanded Price 10‘s, 20‘s, and 30‘s; As per PRC
Approval status of product in Xefo (EMA approved)
Me-too status (with strength and Atcam 8mg tablet of M/s Atco
dosage form)

Brand Name +Dosage Form + Strength Raprol 20mg tablets
Composition Each enteric coated tablet contains:
Rabeprazole sodium………20mg
Type of Form Form-5
Me-too status (with strength and Razole enteric coated tablet 20mg of M/s Semos pharma
dosage form)
Brand Name +Dosage Form + Strength Quetipine 300mg XR tablets
Quetiapine (as fumarate)………300mg
Type of Form Form-5
Me-too status (with strength and Qusel XR 300mg tablet of M/s Hilton pharma
dosage form)
Decision: Approved with USP specification.
Brand Name +Dosage Form + Strength Quetipine 150mg XR tablets
Quetiapine (as fumarate)………150mg
Type of Form Form-5
Me-too status (with strength and Qusel XR 150mg tablet of M/s Hilton pharma

dosage form)
Decision: Approved with USP specification.
91. Name and address of manufacturer / M/s Zephyr Pharmatec Pvt. Ltd., A-39, S.I.T.E. II,
Applicant Super Highway, Karachi.
Brand Name +Dosage Form + Strength Ornate 200mg tablets
Cefpodoxime (as paroxetil)….......200mg
Pharmacological Group Cephalosporin
Type of Form Form-5
Pack size & Demanded Price 10‘s; As per PRC price
Approval status of product in Reference Orelox (MHRA)
Me-too status (with strength and dosage Cefprox Tablets 200mg of M/s SJ&G Fazul Ellahie
form)
Remarks of the Evaluator ● Firm do not have approved manufacturing facility
of “Tablet (cephalosporin)” section.
Decision: Registration Board rejected the application since firm do not have approved
manufacturing facility of “Tablet (Cephalosporin)” section.
Brand Name +Dosage Form + Strength Brisk-P tablets
Tramadol hydrochloride….......37.5mg
Paracetamol……………..........325mg
Pharmacological Group Non-narcotic analgesic
Type of Form Form-5
Pack size & Demanded Price 10‘s and 20‘s; As per PRC
Approval status of product in Reference Tramacet 37.5mg/325mg tablets (MHRA approved)
Me-too status (with strength and dosage Forgesil Plus tablet of M/s Genome Pharmaceuticals
form)
Decision: Approved.
Brand Name +Dosage Form + Strength Brisk 50mg capsule
Tramadol hydrochloride….......50mg
Type of Form Form-5

Pack size & Demanded Price 10‘s; As per PRC price
Approval status of product in Reference Tramadol 50mg capsules (MHRA Approved)
Me-too status (with strength and dosage Lodamart 50mg capsule of M/s Pharmatech
form)
Decision: Approved.
Brand Name +Dosage Form + Strength Ornate dry suspension 100mg/5ml
Cefpodoxime (as paroxetil)….......100mg
Type of Form Form-5
Pack size & Demanded Price 50ml; As per PRC price
Me-too status (with strength and dosage Qink dry suspension 100mg/5ml of M/s Wilshire
form)
Decision: Approved.
Brand Name +Dosage Form + Strength Resplar ER tablet 500mg
Composition Each extended release tablet contains:
Clarithromycin….......500mg
Pharmacological Group Macrolide antibiotic
Type of Form Form-5
Pack size & Demanded Price 5‘s and 14‘s; As per PRC price
Approval status of product in Reference Klaricid XL 500mg tablets (MHRA approved)
Me-too status (with strength and dosage Claritek XL 500mg tablet of M/s Getz
form)
Decision: Approved.
96. Name and address of manufacturer / M/s Ameer and Adnan Pharmaceuticals (Pvt.) Ltd.
Applicant Plot, No.47, Sunder Industrial Estate, Lahore.
Brand Name +Dosage Form + Strength Ademox tablets 400mg
Moxifloxacin (as hydrochloride) ………….400mg
Pharmacological Group Fluoroquinolones
Type of Form Form-5
Approval status of product in Reference Avelox tablets (MHRA approved)
Me-too status (with strength and dosage Izilon 400mg tablets of M/s Bosch Pharmaceuticals
form)
concluding conformance to cGMP in the manufacturing
and QC operations, on the day of inspection.
Brand Name +Dosage Form + Strength Adegem 320mg tablet
Gemifloxacin (as mesylate) ………….320mg
Pharmacological Group Fluoroquinolone antibiotic
Type of Form Form-5
Approval status of product in Reference Factive 320mg tablets (USFDA approved)
Me-too status (with strength and dosage Gatiking 320mg tablets of M/s Welwrd Pharmaceuticals
form)
Brand Name +Dosage Form + Strength Adcipro tablets 500mg
Ciprofloxacin (as hydrochloride) ………….500mg
Diary No. Date of R& I & fee Dy. No.277; 06-02-2017; Rs.20,000/- (06-02-2017) for
250mg tablets
Pharmacological Group Quinolones
Type of Form Form-5
Approval status of product in Reference Ciprofloxacin 500mg film-coated tablets (MHRA
Regulatory Authorities approved)
Me-too status (with strength and dosage Amesure 500mg tablets of M/s Bosch Pharmaceuticals
form)
Remarks of the Evaluator ● Original fee challan for Adcipro 250mg tablets is
attached instead of Adcipro 500mg tablets.
Decision: Deferred for submission of original fee challan for applied formulation.
Brand Name +Dosage Form + Strength Paradol tablets
Tramadol hydrochloride ……….37.5mg
Acetaminophen……..……….….325mg
Pharmacological Group Opiate analogue/Analgesic
Type of Form Form-5
Approval status of product in Reference Tramacet 325/37.5mg film-coated tablets (MHRA
Me-too status (with strength and dosage Radol-P 325/37.5mg film coated tablet of M/s Bosch
form) Pharmaceuticals
Brand Name +Dosage Form + Strength Adlevo 250mg tablet
Levofloxacin (as hemihydrate) ………….250mg
Pharmacological Group Fluoroquinolone antibiotic
Type of Form Form-5
Me-too status (with strength and dosage Julevo 250mg tablets of M/s Jupiter Pharma
form)
Decision: Approved.
Brand Name +Dosage Form + Strength Statemibe tablet
Ezetimibe ………….10mg
Simvastatin ………...10mg
Pharmacological Group HMG Co-A reductase inhibitor
Type of Form Form-5
Me-too status (with strength and dosage Simib tablet 10/10mg of M/s Standpharm
form)

Brand Name +Dosage Form + Strength Adecipro infusion 200mg
Ciprofloxacin (as lactate) ………….200mg
Pharmacological Group Quinolone antibiotic
Type of Form Form-5
Pack size & Demanded Price 100ml x 1‘s; As per SRO
Approval status of product in Reference Ciprofloxacin 2mg/ml solution for infusion (MHRA
Me-too status (with strength and dosage Ciproxin infusion 200mg/100ml of M/s Bayer
form)
Remarks of the Evaluator ● Firm has approved ampoules (General and low
volume infusion) section
Decision: Registration Board referred the case to Licensing Division for confirmation of
manufacturing facility of 100ml infusion.
Evaluator PEC-V
103. Name and address of manufacturer / M/s. High-Q Pharmaceuticals, B 64, KDA-1, Karsaz
Applicant Road, Karachi
Brand Name +Dosage Form + Strength Telmi Tablet 20mg
Telmisartan …..20mg
Diary No. Date of R& I & fee Dy. No. 1373, 24-11-2016 , Rs.20,000/- (23-10-2016)
Pharmacological Group Angiotensin II Receptor Antagonist
Type of Form Form-5
Finished product Specification Inhouse
Pack size & Demanded Price 10‘s,14‘s, 28‘s, As per leader price
Approval status of product in Reference USFDA Approved
Me-too status Registration Number: 045976
Brand Name: Telsartan Tablets.
Manufacturer Name: CCL Pharmaceuticals, (Pvt) Ltd
GMP status Inspection conducted on 19-07-2017
Status: Good level
Remarks of the Evaluator. ● Brand name resemblance with Tasmi of Getz
Pharma.
Other Proposed brand names:
Telista
Telviro
Telviz
● Firm has claimed in-house specification while
the product is present in USP.
● Approved in USFDA with box warning.
Decision: Approved with USP specifications
Type of Form Form-5
Status: Good level
Pharma.
Telista
Telviro
Telviz
● Firm has claimed in-house specification while the
product is present in USP.
Type of Form Form-5
Status: Good level
Pharma.
Telista
Telviro
Telviz
● Firm has claimed in-house specification while the
product is present in USP.
Decision: Approved with USP specifications.

106. Name and address of manufacturer / M/s. Medicraft Pharmaceuticals, 126-B, Industrial
Applicant Estate , Hayatabad, Peshawar, KPK
Brand Name +Dosage Form + Strength Linezomed Tablet 400mg
Linezolid …400mg
Pharmacological Group Antibiotic: Oxazolidinone
Type of Form Form-5
Finished product Specification Not provided
Pack size & Demanded Price 3x4‘s, As per SRO
Approval status of product in Reference Zyvox by Pfizer (USFDA approved)
Me-too status Nezocin by Brooks Pharmaceuticals, Karachi (Reg. No.
055004)
GMP status 18-03-2016, Renewal of DML
Remarks of the Evaluator. Date of Inspection: 30-01-2018
Purpose: Panel Inspection for cGMP.
Conclusion: ―The firm may be considered to be operative
in GOOD level of cGMP compliance. However, it was an
old facility , over space is limited, workload is heavy due
to heavy production of for local and export purposes. The
firm should plan for modification and/ or shifting to wide
area in future. They were also advised to arrange more
fire-extinguishers and improve emergency exits in the
building. They should also make a direct connection with
fire brigade and install smoke detectors.
Decision: Approved with Innovator’s specification.
Brand Name +Dosage Form + Strength Clozamed Tablet 25mg
Clozapine …25mg
Pharmacological Group Antipsychotic; Dibenzodiazepine
Type of Form Form-5
Approval status of product in Reference Denzapine by Britannia
Regulatory Authorities. (MHRA Approved)
Brand Name: Clozaril Tablets
Manufacturer Name: Sandoz Pharma Ltd
GMP status Date of Inspection: 30-01-2018
Conclusion: ―The firm may be considered to be operative in
GOOD level of cGMP compliance. However, it was an old
facility , over space is limited, workload is heavy due to heavy
production of for local and export purposes. The firm should
plan for modification and/ or shifting to wide area in future.
They were also advised to arrange more fire-extinguishers and
improve emergency exits in the building. They should also
make a direct connection with fire brigade and install smoke
detectors.
Remarks of the Evaluator. ● Approved in USFDA with box warning.
Decision: Approved

Brand Name +Dosage Form + Strength Arizole Tablet 10mg
Aripiprazole…10mg
Pharmacological Group Dopamine partial agonist /Antipsychotic
Type of Form Form-5
Approval status of product in Reference TGA Approved
Brand Name: Apify 10mg Tablet
Manufacturer Name: Akhai Kar.
facility , over space is limited, workload is heavy due to
heavy production of for local and export purposes. The firm
should plan for modification and/ or shifting to wide area in
future. They were also advised to arrange more fire-
extinguishers and improve emergency exits in the building.
They should also make a direct connection with fire brigade
and install smoke detectors.
Decision: Approved
Brand Name +Dosage Form + Strength Lamogen Tablet 25mg
Composition Each tablet contain:
Lamotrigine…..25mg
Type of Form Form-5
Approval status of product in Reference Lamictal 25 mg tablet, USFDA Approved
Me-too status Limgit 25mg Tablet of M/s Amarant Karachi (Reg.#
075885)
Remarks of the Evaluator. ● Approved in USFDA with box warning
Decision: Approved
Brand Name +Dosage Form + Strength Lamogen Tablet 50mg
Composition Each tablet contain:
Lamotrigine…..50mg
Type of Form Form-5
Approval status of product in Reference Lamictal 50mg Tablets by GSK, USFDA approved
Me-too status Trimogen tablet of M/s Pharmatec Pak, Karachi
(Reg.#20929)
Remarks of the Evaluator. ● Approved in USFDA with box warning
Decision: Approved
Brand Name +Dosage Form + Strength Paradol Tablet 37.5mg+325mg
Tramadol HCl…..37.5mg
Paracetamol……..325mg
Pharmacological Group Opiate Analogue/Analgesic
Type of Form Form-5
Approval status of product in Reference Ultracet by Janssen (USFDA)
Me-too status Distalgesic Tablets by Atco laboratories, Karachi
(Registration No.073865)
Decision: Approved
Brand Name +Dosage Form + Strength Sitamed Tablet 50mg+500mg
Sitagliptin (as phosphate monohydrate)………..50mg
Metformin HCl…….500mg
Pharmacological Group Dipeptidyl Peptidase-4 Inhibitor/Biguanide
Type of Form Form-5
Approval status of product in Reference TGA Australia approved.
Me-too status Janumet 50/500mg Tablet by M/s OBS, Karachi.
Brand Name +Dosage Form + Strength Sitamed Tablet 50mg+1000mg
Sitagliptin (as phosphate monohydrate)………..50mg
Metformin HCl…….1000mg
Pharmacological Group Dipeptidyl Peptidase-4 Inhibitor/Biguanide
Type of Form Form-5
and install smoke detectors.Liquid syrup section was closed
for approval of renewal by Central Licensing Board.

Brand Name +Dosage Form + Strength Levet Tablet 250mg
Levetiracetam…..250mg
Type of Form Form-5
Approval status of product in Approved by MHRA of UK
Me-too status Keppra Tablets 250mg by M/s AGP (Pvt.) Ltd, Karachi
(Reg. No. 045684)
detectors.
Decision: Approved
Brand Name +Dosage Form + Levet Tablet 500mg
Strength
Levetiracetam…..500mg
Type of Form Form-5
Approval status of product in Approved by MHRA of UK
Me-too status Keppra Tablets 500mg by M/s AGP (Pvt.) Ltd, Karachi
(Reg. No. 045685)
detectors.
Decision: Approved.

Brand Name +Dosage Form + Strength Linezomed Infusion 200mg/100ml
Linezolid….200mg
Pharmacological Group Antibiotic/Oxazolidinone
Type of Form Form-5
Pack size & Demanded Price 1‘s Vial, As per SRO
Approval status of product in ZYVOX linezolid 200mg/100mL injection infusion bag by M/s
Reference Regulatory Authorities. Pfizer Australia Pty Ltd, TGA approved.
Brand Name: Linzy Infusion 200mg
Manufacturer Name: Vision Pharmaceuticals,
detectors.
Decision: Registration Board approved the applied formulation with innovator’s specifications in
―In order to ensure, safety, efficacy and quality of Linezolid infusion, Registration Board
decided as under;
innovator of the product i.e M/s Pfizer which has clearly mention the storage precautions in
its Product Information Leaflet (PIL). They will also make sure that the solution is kept
correctly in its box and foil wrapping in order to protect from light.”
Brand Name +Dosage Form + Strength Levet Oral Solution 100mg/ml
Levetiracetam….100mg
Type of Form Form-5
Pack size & Demanded Price 60ml Bottle, As per SRO
Approval status of product in USFDA Approved
Brand Name: Levotam Oral solution 100mg/ml
Manufacturer Name: Platinum, .
detectors.
Decision: Approved
Brand Name +Dosage Form + Strength Ribamed Tablet 400mg
Ribavirin….400mg
Pharmacological Group Anticyclomegalovirus agent
Type of Form Form-5
Pack size & Demanded Price 10‘s, As per SRO
Approval status of product in USFDA approved.
Me-too status Obsarib of M/s OBS, Karachi (Reg.# 081469)
detectors.
Decision: Approved
Evaluator PEC-XIV
119. Name and address of manufacturer / M/s Medisynth Pharmaceuticals, Plot No. 55, Street No. S-5,
Applicant National Industrial Zone, Rawat, Islamabad.
Brand Name +Dosage Form + Strength Trazmed-XR 100mg Tablets
Composition Each film coated Tablet contains:
Trazodone HCl…………….100mg
Diary No. Date of R& I & fee 3640, 23-05-2017, 20,000/-, 18-05-2017
Pharmacological Group Serotonin antagonist and reuptake inhibitor
Type of Form Form-5
Pack size & Demanded Price 3×10 Tablets in Alu Alu Blister: Not mentioned
Approval status of product in Reference Desyrel 100mg tablet of Pragma Pharma (USFDA) was not
Regulatory Authorities. discontinued or withdrawn for safety and efficacy reasons.
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?ev
ent=BasicSearch.process (Accessed on : 08-04-2018)
Me-too status Deprel 100mg Tablets by M/s Adamjee (Reg # 010178)
GMP status Last GMP inspection conducted on 19-09-2017 and the report
concludes that the firm is operating at fair level of GMP
compliance.
Brand Name +Dosage Form + Strength Febusyn 40mg Tablets
Febuxostat……………….40mg
Pharmacological Group Xanthine oxidase inhibitor
Type of Form Form-5
Finished product Specification In-house
Approval status of product in Reference Uloric 40mg tablet of Takeda Pharma, USFDA
Me-too status Febux 40mg Tablet by M/s CCL (Reg # 068106)
report concludes that the firm is operating at fair level of
GMP compliance.
Brand Name +Dosage Form + Strength Cycloprin 5mg Tablet
Cyclobenzaprine as HCl……………..5mg
Pharmacological Group Muscle relaxant, Centrally acting agent
Type of Form Form-5
Approval status of product in Reference Flexeril 5mg Tablets of Janssen Res and Dev, USFDA
Me-too status Flexagil 5mg Tablet by M/s CCL (Reg # 062767)
report concludes that the firm is operating at fair level of GMP
compliance.
Decision: Approved
Brand Name +Dosage Form + Strength Trazmed-XR 50mg Tablets
Trazodone HCl…………….50mg
Pharmacological Group Serotonin antagonist and reuptake inhibitor
Type of Form Form-5
Approval status of product in Reference Desyrel 50mg tablet of Pragma Pharma (USFDA) was not
Regulatory Authorities. discontinued or withdrawn for safety and efficacy reasons.
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?ev
ent=BasicSearch.process (Accessed on : 08-04-2018)
Me-too status Deprel 50mg Tablets by M/s Adamjee (Reg # 010177)
compliance.

Brand Name +Dosage Form + Strength Febusyn 80mg Tablets
Type of Form Form-5
Approval status of product in Reference Uloric 80mg tablet of Takeda Pharma, USFDA
Me-too status Febux 80mg Tablet by M/s CCL (Reg # 068107)
compliance.
124. Name and address of manufacturer / M/s Medizan Laboratories (Pvt) Ltd. Plot No. 313, Industrial
Applicant Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Co-Vimax Tablets
Composition Each Film coated tablet contains:
Amlodipine as besylate…………10mg
Valsartan……………………….160mg
Hydrochlorothiazide………….12.5mg
Diary No. Date of R& I & fee 4116, 29-05-2017, 25-05-2017, 20,000/-
Pharmacological Group Anti-hypertensive
Type of Form Form-5
Pack size & Demanded Price 14‘s; As decided by the Ministry of health
Approval status of product in Reference Exforge HCT tablets of Novartis, USFDA
Me-too status Co-Extor Tablets of Searle Pakistan (Reg # 071437)
GMP status GMP inspection report conducted on 20-11-2017
concluding acceptable level of GMP compliance.
Brand Name +Dosage Form + Strength Tefine 125mg Tablet
Terbinafine………..…..125mg
Pharmacological Group Antifungal
Type of Form Form-5
Pack size & Demanded Price 1×10‘s; As decided by the Ministry of health
Me-too status Funge tablet of Wilshire Pharma (Reg # 040949)
Remarks of the Evaluator. The firm has submitted revised Form-5 alongwith fee of Rs.
5,000/- (Deposit slip No. 0717762) dated 05-04-2018.The
correct formulation is as under:
Each Film coated tablet contains:
Terbinafine as HCl………..…..125mg
Brand Name +Dosage Form + Strength Tefine 250mg Tablet
Terbinafine………..…..250mg
Type of Form Form-5
Approval status of product in Reference Lamisil tablet of Novartis Pharma, USFDA
Me-too status Funge Tablet of Wilshire (Reg # 038026)
Remarks of the Evaluator. The firm has submitted revised Form-5 alongwith fee of Rs.
5,000/- (Deposit slip 0717760) dated 05-04-2018.The correct
formulation is as under:
Each Film coated tablet contains:
Terbinafine as HCl………..…..250mg
Brand Name +Dosage Form + Strength Epimax 50mg Tablet
Eperisone HCl…………………50mg
Pharmacological Group Muscle relaxant, Centrally acting agent
Type of Form Form-5
Approval status of product in Reference Musolax tablet of Daewoo Pharma, Thailand
Regulatory Authorities. Exoperin tablets of Hanmi, South Korea
Me-too status Kyonal Tablet of Eissi Co Japan (Reg # 010644)
Remarks of the Evaluator. Evidence of approval of applied formulation in authould not
be confirmed. Provide correct reference.
Decision: Deferred for evidence of approval of applied formulation in reference regulatory
authorities/agencies which were declared/approved by the Registration Board in its 275th meeting.
Brand Name +Dosage Form + Strength Atohype 25mg capsule
Atomoxetine as HCl……………..25mg
Pharmacological Group Antidepressant , ADHD
Type of Form Form-5
Pack size & Demanded Price 30‘s ; As decided by the Ministry of health

Approval status of product in Reference Strattera capsule 25mg of Eli Lilly and company (USFDA)
Me-too status Attentra capsules of Reko Pharma (Reg # 067835)
Brand Name +Dosage Form + Strength Atohype 10mg capsule
Atomoxetine as HCl……………..10mg
Type of Form Form-5
Pack size & Demanded Price 30‘s ; As decided by the Ministry of health
Approval status of product in Reference Strattera capsule 10mg of Eli Lilly and company (USFDA)
Me-too status Attentra capsules of Reko Pharma (Reg # 067834)
Brand Name +Dosage Form + Strength Nebifix 10mg tablet
Composition Each Film Coated Tablet contains:
Nebivolol as HCl………………10mg
Pharmacological Group β 1 receptor Blocker
Type of Form Form-5
Approval status of product in Reference Bystolic tablets of Allergan Sales (USFDA)
Me-too status Nebil tablet of GETZ Pharma (Reg # 061346)
Brand Name +Dosage Form + Strength Nebifix 5mg tablet
Nebivolol as HCl………………5mg
Pharmacological Group β 1 receptor Blocker
Type of Form Form-5
Pack size & Demanded Price 10‘s, 14‘s; As decided by the Ministry of health
Approval status of product in Reference Bystolic tablets of Allergan sales (USFDA)
Me-too status Nebil tablet of GETZ Pharma (Reg # 061345)

Brand Name +Dosage Form + Strength Co-Vmed tablets
Amlodipine as besylate…………5mg
Valsartan……………………….160mg
Hydrochlorothiazide………….12.5mg
Pharmacological Group Antihypertensive
Type of Form Form-5
Approval status of product in Reference Exforge HCT tablets of Novartis Pharma (USFDA)
Me-too status Co-Extor Tablets of Searle Pakistan (Reg # 071438)
Brand Name +Dosage Form + Strength Masakal-800mg Tablets
Composition Each Delayed release tablet contains:
Mesalazine………………800mg
Pharmacological Group Anti-inflammatory
Type of Form Form-5
Approval status of product in Reference Mesalamine delayed release tablet of Zydus Pharma (USFDA
Regulatory Authorities. approved)
Me-too status Masacol Tablets of GETZ Pharma (Reg # 061348)
Brand Name +Dosage Form + Strength Meflar Tablet
Mefloquine HCl…………………..250mg
Artesunate………………………..200mg
Pharmacological Group Anti-Malarial
Type of Form Form-5
Approval status of product in Reference Mefliam Plus Tablets
Me-too status Artiquin Tablets of Genome Pharma
Remarks of the Evaluator. Evidence of approval of applied formulation in reference
regulatory authority and me-too status could not be confirmed.
authorities/agencies as adopted by Registration Board in its 275th meeting or WHO and evidence of
me-too status as submitted reference is not verifiable.
135. Name and address of manufacturer / M/s Martin Dow limited. Plot No. 37, Sector 19,
Applicant KorangiIndustrial Area, Karachi
Brand Name +Dosage Form + Strength Laxocare Tablets
Composition Each uncoated tablet contains:
Sodium Picosulfate Monohydrate eq. to Sodium
Picosulfate……………….5 mg
Pharmacological Group Contact Laxative
Type of Form Form-5
Pack size & Demanded Price 10×10‘s; 300/100‘s
Approval status of product in Reference Laxoberal laxative tablets of Sanofi Aventis Germany.
Me-too status U-Salax by Usawa (Reg. 075548)
GMP status Last inspection report conducted on 7,8-6-2017, good level of
compliance with GMP
Decision: Approved with innovator’s specifications.
136. Name and address of manufacturer / M/s Martin Dow limited. Plot No. 37, Sector 19,
Applicant KorangiIndustrial Area, Karachi
Brand Name +Dosage Form + Strength Laxocare Liquid
Sodium Picosulfate ……………….5 mg
Pharmacological Group Contact Laxative
Type of Form Form-5
Pack size & Demanded Price 120ml; 95/120ml
Approval status of product in Reference Dulcolax Pico Liquid of Berkshire (MHRA)
Me-too status Conspic 7.5mg/ml of Sami
GMP status Last inspection report conducted on 7,8-6-2017, good level of
compliance with GMP
Remarks of the Evaluator. Evidence of generic/me-too reference could not be verified.
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic /
me-too status) alongwith registration number, brand name and name of firm.
137. Name and address of manufacturer / M/s Danas Pharma. 312-Industrial Triangle, Kahuta Road,
Applicant Islamabad.
Brand Name +Dosage Form + Strength Trisma Cream
Composition Each gram contains:
Fluocinolone Acetonide…………0.1gm
Hydroquinone…………………….40mg
Tretinoin………………………….0.5mg
Pharmacological Group Skin Bleaches/Vitamin A derivative/corticosteroid
Type of Form Form-5
Pack size & Demanded Price 30gm; As per SRO
Approval status of product in Reference Tri-luma cream of Galderma Labs, USFDA

Me-too status Trimelasin cream of Valor (Reg # 031104)
GMP status The firm was granted GMP certificate based on inspection
conducted on 03-10-2017.
Decision: Deferred for clarification of pharmacological group.
Brand Name +Dosage Form + Strength Neuvita Injection
Composition Each Ampoule (3ml) contains:
Thiamine HCl (Vitamin B1)……………100mg
Pyridoxine HCl (Vitamin B6)……….…100mg
Cyanocobalamin (Vitamin B12)………1000mcg
Pharmacological Group Vitamins
Type of Form Form-5
Pack size & Demanded Price 3 ml × 25‘s; As per SRO
Approval status of product in Reference Neurobion solution for Injection 3ml by M/s Merck
Regulatory Authorities. Selbstmedikation GmbH (Germany Approved)
Me-too status Neurolina Injection 3ml by M/s Alina Combine (Reg#076143)
Decision: Approved with innovator’s specifications and shelf life.
Brand Name +Dosage Form + Strength Neuvita Tablet
Thiamine HCl (Vitamin B1)……………100mg
Pyridoxine HCl (Vitamin B6)……….…100mg
Cyanocobalamin (Vitamin B12)………200mcg
Type of Form Form-5
Approval status of product in Reference Could not be confirmed.
Me-too status Neurobion of GSK
Neurobedoxin of schazoo labs
regulatory authority & me-too reference could not be verified.
authorities/agencies as adopted by Registration Board in its 275th meeting and evidence of me-too
status.
Brand Name +Dosage Form + Strength Danidol Extra Tablet
Paracetamol………………..500mg
Caffeine……………………65mg

Pharmacological Group Non-narcotic analgesic/Xanthine
Type of Form Form-5
Pack size & Demanded Price 10×10‘s; As per SRO
Me-too status Paratol Extra of Highnoon (Reg # 013346)
Decision: Approved.
Brand Name +Dosage Form + Strength Soriodan-B Ointment
Calcipotriol…………..0.05mg
Betamethasone (as dipropionate)………..0.5mg
Pharmacological Group Anti-psoriatic
Type of Form Form-5
Pack size & Demanded Price 30g ointment filled in Alu Tubes; As per SRO
Me-too status Daivobet of Zam Zam corporation (Reg # 031379)
142. Name and address of manufacturer / M/s Maple Pharmaceuticals (pvt) Ltd., 147/23, Korangi
Applicant Industrial Area, Karachi
Brand Name +Dosage Form + Strength Metopro 100mg Tablet
Metoprolol tartrate………………100mg
Type of Form Form-5
Pack size & Demanded Price 30‘s ; As per PAC/PRC
Approval status of product in Reference Metoprolol tartrate 100mg of Milpharm, MHRA
Me-too status Carsel 100mg tablet of M/s Unimark pharmaceuticals
GMP status Last GMP inspection was conducted on 24-07-2017 and the
report concludes acceptable level of GMP compliance.
143. Name and address of manufacturer / M/s Lowitt Pharma (Pvt.) Ltd. 24-Industrial Estate,
Applicant Hayatabad, Peshawar.
Brand Name +Dosage Form + Strength P-Gablin Capsules
Pregabalin………………….75mg
Pharmacological Group GABA Analogue
Type of Form Form-5

Pack size & Demanded Price 2 ×7‘s ; As per SRO
Approval status of product in Reference Lyrica 75mg Capsule of M/s PF Prism CV, (USFDA)
Me-too status Lyrica 75mg Capsule of M/s Pfizer
GMP status ● Inspection conducted on 07-07-2017 showed good level of
GMP compliance
Evaluator PEC-XIII
144. Name and address of manufacturer / M/s High-Q Pharmaceuticals, Plot # 224, Sector 23, Korangi
Applicant Industial Area, Karachi
Brand Name+ Dosage Form+Strength Nebix tablet 2.5mg
Nebivolol (as HCl)…………………………...2.5mg
Pharmacological Group Anti-hypertensive drug ( Beta blocker )
Type of Form Form-5
Finished product Specification Manufacturers
Pack size & Demanded Price 10‘s , 14‘s, 30‘s & as per leader price
Approval status of product in Reference MHRA Approved
Me-too status Byscard 2.5mg tablets of M/s Searle Pharmaceutical
concludes good level of GMP compliance.
Remarks of the Evaluator ● The applied drug is non- pharmacopoeial.
Brand Name + Dosage Form + Strength Nebix tablet 5mg
Nebivolol (as HCl)………………………….....5mg
Type of Form Form-5
Me-too status Byscard 5mg tablets of M/s Searle Pharmaceutical
Brand Name + Dosage Form + Strength Nebix tablet 10mg
Nebivolol (as HCl)………………………….....10mg
Type of Form Form-5

Me-too status Byscard 10mg tablets of M/s Searle Pharmaceutical
Brand Name + Dosage Form + Strength Voricole tablet 50mg
Composition Each film-coated tablet contains:
Voriconazole …………………………............50mg
Pharmacological Group Anti- fungal agent
Type of Form Form-5
Pack size & Demanded Price 10‘s & as per leader price
Me-too status Vorif 50mg tablets of M/s Ferozesons Laboratories (Reg. #
069764)
Remarks of the Evaluator ● The official monograph of the applied formulation is
available in J.P.
Decision: Approved with JP specifications
Brand Name + Dosage Form + Strength Voricole tablet 200mg
Voriconazole …………………………............200mg
Type of Form Form-5
Me-too status Vorif 200mg tablets of M/s Ferozesons Laboratories (Reg. #
069785)
available in J.P.
Decision: Approved with JP specifications.
Brand Name + Dosage Form + Strength Dermafine tablet 125 mg
Terbinafine (as HCl)…………………............125mg
Type of Form Form-5

Finished product Specification U.S.P.
Me-too status Lamisil 125mg tablets of M/s Novartis Pharma
(Reg. # 013208)
Brand Name + Dosage Form + Strength Dermafine tablet 250 mg
Terbinafine (as HCl)…………………............250mg
Type of Form Form-5
Me-too status Lamisil 250mg tablets of M/s Novartis Pharma
(Reg. # 013209)
Brand Name + Dosage Form + Strength Pyloclar DS Dry suspension 250mg/5ml
Clarithromycin ………………………............250mg
Pharmacological Group Antibiotic (Macrolide)
Type of Form Form-5
Pack size & Demanded Price 60ml, 70ml& as per leader price
Approval status of product in Reference Klaricid granules for suspension 250mg/5ml ( MHRA
Regulatory Authorities. Approved)
Me-too status Claritek suspension 250mg/5ml of M/s Getz Pharma
Decision: Deferred for consideration according to queue of the application and submission of for
source of granules of clarithromycin, along with stability studies data, GMP certificate of supplier
and differential fee in case of import of pellets.
152. Name and address of manufacturer / M/s Hilton Pharma (Pvt.) limited, Plot # 13-14, Sector 15,
Applicant Korangi Industrial Area, Karachi.
Brand Name + Dosage Form + Strength Rivar tablet 2.5mg
Rivaroxaban ......................2.5mg
Diary No. Date of R& I & fee Dy. No. 2266; 11-05-2017; Rs.20,000/- (10-05-2017)
Pharmacological Group Anti-thrombotic
Type of Form Form-5
Pack size & Demanded Price 10‘s, 14‘s, 20‘s, 28‘s, 30‘s & as per DPC
Approval status of product in Reference Xarelto tablets of M/s Baeyer UK (MHRA Approved)
Me-too status Xarelto tablets of M/s Baeyer , Pakistan
report concludes satisfactory level of GMP compliance.
Remarks of the Evaluator ● The applied drug is non-pharmacopoeial.
Decision: Approved
153. Name and address of manufacturer / M/s Jenner Pharmaceuticals (Pvt) limited, 26- Km Lahore
Applicant Sharaqpur Road, Sheikhupura
Brand Name + Dosage Form + Strength Razole tablets 20mg
Composition Each enteric-coated tablet contains:
Rabeprazole (as Sodium)................................20mg
Pharmacological Group Proton Pump Inhibitor
Type of Form Form-5
Pack size & Demanded Price 10‘s & as per SRO
Approval status of product in Reference Rabeprazole 20mg GR tablets of M/s Actavis , UK (MHRA
Me-too status Rabecid tablets 20mg of M/s Highnoon
(Reg. # 028360 )
Decision: Approved with Innovator’s specifications and change of brand name.
Brand Name + Dosage Form + Strength Mecam tablets 15mg
Meloxicam ...................15mg
Pharmacological Group Anti-inflammatory & Anti-rheumatic
Type of Form Form-5
Approval status of product in Reference Movalis tablets 15mg of M/s Aspen Pharma (Australia TGA
Me-too status Xobix tablets 15mg of M/s Hilton Pharma
(Reg. # 023929)
Brand Name + Dosage Form + Strength Mecam tablets 7.5mg
Meloxicam.......................7.5mg
Pharmacological Group Anti-inflammatory & Anti-rheumatic
Type of Form Form-5
Approval status of product in Reference Movalis tablets 7.5mg of M/s Aspen Pharma (Australia TGA
Me-too status Xobix tablets 7.5mg of M/s Hilton Pharma
(Reg. # 023928)
Brand Name + Dosage Form + Strength Aukast tablets 10mg
Montelukast (as Sodium).............................10mg
Pharmacological Group Anti-asthmatic
Type of Form Form-5
Approval status of product in Reference Singulair tablets 10mg of M/s Merck Sharp & Dohme,
Regulatory Authorities. Australia (TGA Approved)
Me-too status Montiget 10mg tablets of M/s Getz Pharma
(Reg. # 034838)
Brand Name + Dosage Form + Strength Pirox tablets 20mg
Composition Each dispersible tablet contains:
Piroxicam ...........................20mg
Pharmacological Group NSAIDs
Type of Form Form-5
Approval status of product in Reference Genrx dispersible tablets 20mg of M/s Apotex Limited,
Regulatory Authorities Australia (TGA Approved)
Me-too status Feldene tablets 20mg of M/s Pfizer Pharmaceuticals (Reg. #
020650)
Decision: Approved with innovator’s specifications and change of brand name
Brand Name + Dosage Form + Strength Rapox tablets 20mg
Paroxetine (as HCl )...........................20mg
Pharmacological Group Anti-depressants (SSRI)
Type of Form Form-5
Approval status of product in Reference Paroxetine 20mg tablets of M/s Generics, UK ( emc MHRA
Me-too status Seroxat tablets 20mg of M/s GSK, Pakistan
(Reg. # 019506)
Decision: Approved
Brand Name + Dosage Form + Strength Napxen tablets 550mg
Naproxen Sodium ............................................550mg
Type of Form Form-5
Approval status of product in Reference Crysanal 550mg tablets of M/s Atnahs Pharma, Australia (
Regulatory Authorities TGA Approved)
Me-too status Xaprox tablets 550mg of M/s Pfizer, Pakistan
(Reg. # 067374)
Decision: Approved
Brand Name + Dosage Form + Strength Apentin capsules 100mg
Gabapentin ........................100mg
Type of Form Form-5
Approval status of product in Reference Gabapentin capsule 100mg of M/s Actavis, UK (emc MHRA
Me-too status Duogab capsules 100mg of M/s Searle Pharmaceuticals ( Reg.
# 039683)
Decision: Approved
Brand Name + Dosage Form + Strength Apentin capsules 300mg
Gabapentin .................................................300mg
Type of Form Form-5

Approval status of product in Reference Gabapentin capsule 300mg of M/s Actavis, UK ( emc MHRA
Me-too status Duogab capsules 300mg of M/s Searle Pharmaceuticals ( Reg.
# 039684)
Decision: Approved
Brand Name + Dosage Form + Strength Thicol capsules 4mg
Thiocolchicoside ...........................................4mg
Type of Form Form-5
Approval status of product in Reference ANSM (France Approved)
Me-too status Muscoril capsules 4mg of M/s Sanofi Aventis, Pakistan ( Reg.
# 015502)
Remarks of the Evaluator ● The applied formulation is non- pharmacopoeial.
Decision: Approved with Innovator’s specifications and change of brand name.
163. Name and address of manufacturer / M/s Pearl Pharmaceuticals, Plot # 204, Street 1, I-10/3,
Brand Name + Dosage Form + Strength Terbipearl oral tablet 125mg
Terbinafine as HCl eq. to Terbinafine..............125mg
Pharmacological Group Anti- fungal
Type of Form Form-5
Finished product Specification B.P.
Pack size & Demanded Price 1x10‘s & as per SRO
Me-too status Terbin oral tablet of M/s Martin Dow Pharmaceuticals
(Reg. # 028975)
available in U.S.P. while firm has applied B.P.
monograph.
Decision: Approved with U.S.P. specifications.
Brand Name + Dosage Form + Strength Terbipearl oral tablet 250mg
Terbinafine as HCl eq. to Terbinafine..............250mg
Type of Form Form-5
Finished product Specification B.P.
Approval status of product in Reference Lamisil tablet 250mg of M/s Novartis (USFDA Approved)
Me-too status Terbin tablet 250mg of M/s Martin Dow Pharmaceuticals
(Reg. # 049235)
available in U.S.P. while firm has applied B.P.
monograph.
Decision: Approved with U.S.P. specifications.
Brand Name + Dosage Form + Strength Linzopearl oral tablet 400mg
Linezolid ...................................400mg
Type of Form Form-5
Me-too status Ecasil tablet of M/s Sami Pharmaceuticals
(Reg. # 067162)
Remarks of the Evaluator ● The firm has applied USP specifications while it is a
non-pharmacopoeial product.
Decision: Approved with innovators’ specifications.
Brand Name + Dosage Form + Strength Linzopearl oral tablet 600mg
Linezolid ...........................600mg
Type of Form Form-5
Me-too status Ecasil tablet of M/s Sami Pharmaceuticals
(Reg. # 066904)
Remarks of the Evaluator ● The firm has applied USP specifications while it is a
non- pharmacopoeial product.
Decision: Approved with innovators’ specifications.

Brand Name + Dosage Form + Strength Cyprex oral suspension 250mg/5ml
Composition Each 5ml of suspension contains:
Ciprofloxacin HCl eq. to Ciprofloxacin...…...250mg
Type of Form Form-5
Pack size & Demanded Price 1x100ml & as per SRO
Me-too status Hiflox Dry suspension of M/s Hilton Pharma
(Reg. # 067499)
Remarks of the Evaluator ● Dry suspension is not mentioned in the composition
of Form-5.
● The applied pharmacological group is antifungal.
Decision: Registration Board rejected the application since applied formulation has alreay been
registered in the name of applicant.
168. Name and address of manufacturer / M/s Rock Pharmaceutical Laboratories (Pvt) Limited,
Applicant 134-B & 135-B, Noushehra Industrial Estate, Risalpur
Brand Name + Dosage Form + Strength Ropol tablets 500mg
Paracetamol …………......................................500mg
Pharmacological Group Non- Narcotic Analgesic
Type of Form Form-5
Me-too status Panadol tablet 500mg of M/s GSK (Reg. # 000817)
GMP status Last GMP inspection report dated 07-12-2017 with no
conclusion.
Remarks of the Evaluator ● A banned excipient called Methylene Chloride is
mentioned to be used under the heading of
specifications in Annexure-D of the dossier.
● The GMP report does not mention any conclusion.
report submitted by firm does not conclude GMP compliant status and justification of addition of a
banned excipient named Methylene Chloride.
Brand Name + Dosage Form + Strength Macrozith tablet 500mg
Azithromycin Dihydrate eq. to Azithromycin.....500mg
Pharmacological Group Macrolide
Type of Form Form-5

Me-too status Azomax tablet 500mg of M/s Novartis Pharma
conclusion.
Brand Name + Dosage Form + Strength Valsam tablet 10mg/160mg
Amlodipine (as Besylate)………………….10mg
Valsartan………………………………….160mg
Pharmacological Group Angiotensin II antagonist and calcium channel blocker
Type of Form Form-5
Approval status of product in Reference Exforge tablet 10mg/160mg of M/s Novartis Pharmaceuticals
Regulatory Authorities (USFDA Approved)
Me-too status Exforge tablet 10mg/160mg of M/s Novartis Pharma, Pak
(Reg. # 047571)
conclusion.
Brand Name + Dosage Form + Strength Roxart tablet 20mg/120mg
Artemether………………….20mg
Lumefantrine ……………...120mg
Pharmacological Group Antimalarial
Type of Form Form-5
Finished product Specification International Pharmacopoeia
Approval status of product in Reference WHO Approved as Dispersible tablet
Me-too status Artheget tablet 20mg/120mg of M/s Getz Pharmaceuticals,
Pak ( Reg. # 042295)
conclusion.
Remarks of the Evaluator ● The GMP report does not mention any conclusion.
● The applied formulation is approved in WHO
prequalified list as dispersible tablet while not applied
as dispersible.
report submitted by firm does not conclude GMP compliant status and type of dosage form as
dispersible tablet is approved in reference regulatory authorities while not applied as dispersible.
Brand Name + Dosage Form + Strength Roxart tablet 80mg/ 480mg
Artemether………………….80mg
Lumefantrine ……………...480mg
Pharmacological Group Antimalarial
Type of Form Form-5
Finished product Specification International Pharmacopoeia
Approval status of product in Reference WHO Approved formulation
Me-too status Artheget tablet 80mg/ 480mg of M/s Getz Pharmaceuticals,
Pak ( Reg. # 058405)
conclusion.
report submitted by firm does not conclude GMP compliant status
Brand Name + Dosage Form + Strength Cafegot tablet 1mg/ 100mg
Ergotamine tartarate…………………...1mg
Caffeine ( anhydrous).……..………...100mg
Pharmacological Group Ergot Alkaloid/ Xanthine
Type of Form Form-5
Pack size & Demanded Price 2x 10‘s & as per SRO
Me-too status Cafergot of M/s Novartis Pharmaceuticals
conclusion.
● The strength is not mentioned on fee- challan.
report submitted by firm does not conclude GMP compliant status and verification of the submitted
fee- challan from Budget & Accounts Division.
174. Name and address of manufacturer / M/s Hiranis Pharmaceuticals (Pvt) limited, Plot # E-145 to E-
Applicant 149, North Western Industrial Zone, Port Qasim, Karachi
Brand Name + Dosage Form + Strength Espercil Oral Suspension 200mg/5ml
Metronidazole (as benzoate) ………………..200mg
Pharmacological Group Amoebicide

Type of Form Form-5
Pack size & Demanded Price As per PRC & as per PRC
Approval status of product in Reference Flagyl-S 200mg/5ml oral suspension of M/s Sanofi Aventis,
Regulatory Authorities UK Ireland (MHRA Approved)
Me-too status Flagyl 200mg/5ml oral suspension of M/s Sanofi Aventis,
Pakistan (Reg. # 001214)
Decision: Approved
175. Name and address of manufacturer / M/s Hiranis Pharmaceuticals (Pvt) limited, Plot # E-145 to E-
Applicant 149, North Western Industrial Zone, Port Qasim, Karachi
Brand Name + Dosage Form + Strength Orazole Gel 2% w/w
Composition Each g contains:
Miconazole Nitrate………………..20mg
Type of Form Form-5
Pack size & Demanded Price 20g & as per PRC
Approval status of product in Reference Daktarin Oral Gel w/w of M/s Janssen Cilag, UK (MHRA
Me-too status Daktacort Gel 2% w/w of M/s Janssen Cilag, Pakistan (Reg. #
009078)
Remarks of the Evaluator ● Firm has relevant section as Cream/ Ointment/Gel
Section.
Decision: Approved
176. Name and address of manufacturer / M/s Helix Pharma (Pvt) Ltd., A-56, S.I.T.E., Manghopir
Brand Name + Dosage Form + Strength Hitex Ophthalmic Solution 0.3%
Hypromellose ………………..3mg
Type of Form Form-5
Pack size & Demanded Price 10ml & as per PRC
Approval status of product in Reference Gen Teal of M/s Novartis Pharmaceuticals, Canada
Me-too status Softeal of M/s Sante (Pvt) limited, Pakistan
Remarks of the Evaluator ● The official monograph is available in USP and BP.
177. Name and address of manufacturer / M/s Hudson Pharma (Pvt) limited, D-93, North Western
Applicant Industrial Zone, Port Qasim, Karachi
Brand Name + Dosage Form + Strength Parason Injection 300mg/2ml
Composition Each 2ml ampoule contains:
Paracetamol …………………….300mg
Type of Form Form-5
Pack size & Demanded Price 1‘s x 2ml , 5‘s x 2ml & as per SRO
Approval status of product in Reference Not provided
Me-too status Provas of M/s Sami Pharmaceuticals (Reg. # 022359)
report concludes acceptable level of GMP compliance.
Moreover, the firm is advised to submit the action plan on
suggestions given by FID.
Remarks of the Evaluator ● The international availability couldn‘t be confirmed.
● The applied formulation is non- pharmacopoeial.
authorities/agencies as adopted by Registration Board in its 275th meeting.
178. Name and address of manufacturer / M/s Tabros Pharma (Pvt) limited, L-20/B, Sector-22, Federal
Applicant B Industrial Area, Karachi
Brand Name + Dosage Form + Strength Cresar AM tablet 5mg/ 40mg
Composition Each bilayered tablet contains:
Amlodipine Besylate eq. to Amlodipine……….5mg
Telmisartan …………………………………...40mg
Type of Form Form -5
Finished product Specification As per Innovators‘ specifications
Pack size & Demanded Price 14‘s & Rs. 600/- for 14‘s
Me-too status Amtas tablet 5mg/ 40mg of M/s Getz Pharmaceutical,
GMP status Latest GMP inspection was conducted on 12-10-2017 and the
report concludes good GMP compliance.
Decision: Deferred for the consideration on its turn
Amlodipine Besylate eq. to Amlodipine………10mg
Telmisartan …………………………………....40mg
Pack size & Demanded Price 14‘s & Rs. 620/- for 14‘s

Amlodipine Besylate eq. to Amlodipine………5mg
Telmisartan …………………………………..80mg
Pack size & Demanded Price 14‘s & Rs. 85/- per tablet
Amlodipine Besylate eq. to Amlodipine……..10mg
Telmisartan …………………………………..80mg
Pack size & Demanded Price 14‘s & Rs. 85.71/- per tablet
Me-too status Am- Telsan of M/s Hilton Pharma
Decision: Deferred for the consideration on its turn.
182. Name and address of manufacturer / M/s Welmark Pharmaceuticals, Plot # 122, Block-B, Phase-V,
Applicant Industrial Estate, Hattar, NWFP
Brand Name + Dosage Form + Strength L-zolid tablet 400mg
Linezolid ……………....…………..400mg
Pack size & Demanded Price As per SRO & as per SRO
Approval status of product in Reference Zyvox 400 mg tablet by Pharmacia and Upjohn Pharma
Regulatory Authorities (USFDA)
Me-too status Ecasil 400mg tablet of M/s Sami Pharma
(Reg. # 067162)
report concludes the firm to be GMP compliant.
Remarks of the Evaluator ●
Two strengths have been mentioned on the submitted
fee-challan.
Decision: Registration Board deferred the case and decided that reference will be sent to Budget &
Accounts Division for confirmation of fee for applied product.
Brand Name + Dosage Form + Strength Rifixawel tablet 550mg
Rifaximin ……………....…………………….550mg
Pharmacological Group Semi-synthetic Antibiotic
Pack size & Demanded Price 10‘s & as per policy of MOH
Approval status of product in Reference TGA (Australia Approved)
Me-too status Nimixa 550mg tablet of M/s Getz Pharma
Remarks of the Evaluator ● Justification of 3% overage.
Decision: Deferred for consideration according to queue of the application
Brand Name + Dosage Form + Strength Trimark tablets 80mg/80mg
Phloroglucinol (hydrated corresponding to 62.233mg
anhydrous Phloroglucinol)….. ……………80mg
Trimethylphloroglucinol…………………..80mg
Pharmacological Group Antispasmodic
Pack size & Demanded Price As per SRO & as per policy of MOH
Approval status of product in Reference Spasfon (ANSM) France Approved
Me-too status Spasfon tablet of M/s Himont Pharmaceuticals
(Reg.# 018529)
Remarks of the Evaluator ● Applied strength is not mentioned on the submitted
fee-challan.
● Film-coating is also mentioned in the master
formulation.
● Approved in France as sugar-coated while applied as
film-coated.
Brand Name + Dosage Form + Strength Welstate tablet 40mg

Pharmacological Group Anti-gout preparations
Pack size & Demanded Price As per SRO & as per policy of MOH
Me-too status Zurig 40mg tablet of M/s Getz Pharmaceuticals
(Reg. # 067290)
Remarks of the Evaluator ● Justification of 3% overage.
● Applied strength is not mentioned on the submitted
fee-challan.
● Film-coating is also mentioned in the master
formulation while not in the label claim of Form-5.
Brand Name + Dosage Form + Strength Welcomide tablet 50mg
Lacosamide ………………………50mg
Pack size & Demanded Price 2x 7‘s & as per policy of MOH
Approval status of product in Reference Vimpat 50mg tablet of M/s UCB INC Pharmaceuticals,
Me-too status Lalap 50mg tablet of M/s Genix Pharma
(Reg. # 070458)
Brand Name + Dosage Form + Strength Welcomide tablet 100mg
Lacosamide ………………………100mg
Finished product Specification Innovators specifications
Pack size & Demanded Price 2x 7‘s & as per policy of MOH
Approval status of product in Reference Vimpat 100mg tablet of M/s UCB INC Pharmaceuticals,
(Reg. # 070459)

188. Name and address of manufacturer / M/s Kaizen Pharmaceuticals (Pvt) limited, E-127-129, North
Applicant Western Industrial Zone, Bin Qasim, Karachi
Brand Name + Dosage Form + Strength Rivarox tablet 10mg
Rivaroxaban ...………………………………..10mg
Diary No. Date of R& I & fee Dy. No.6293, 15-06-2017; Rs.20,000/- (07-06-2017)
Pharmacological Group Anti- thrombotic
Finished product Specification Innovators Specifications
Pack size & Demanded Price 10‘s, 20‘s, 30‘s & as per PRC
Me-too status Xaroban of M/s Searle Pharmaceuticals
report concludes renewal of DML.
Remarks of the Evaluator ● Boxed warning shows its discontinuation may cause
increased risk of stroke and spinal/ epidural hematoma
in patients with non-valvular atrial fibrillation.
Rivaroxaban ...………………………………..15mg
Me-too status Xarelto of M/s Baeyer Health Laboratories
in patients with nonvalvular atrial fibrillation.
Rivaroxaban ...………………………………..20mg
Me-too status Xarelto of M/s Baeyer Health Laboratories
in patients with nonvalvular atrial fibrillation.
Brand Name + Dosage Form + Strength Rosutin tablet 10mg
Rosuvastatin (as Rosuvastatin Calcium).……..10mg
Pharmacological Group Statin or HMG CoA Reductase Inhibitor
Approval status of product in Reference Crestor of M/s Astrazeneca PMDA ( Japan Approved)/
Regulatory Authorities USFDA Approved
Me-too status X-plended of M/s Pharmevo Pakistan
Decision: Approved
Brand Name + Dosage Form + Strength Rosutin tablet 20mg
Rosuvastatin (as Rosuvastatin Calcium).……..20mg
Pharmacological Group Statin or HMG CoA Reductase Inhibitor
Approval status of product in Reference Crestor of M/s Astrazeneca PMDA ( Japan Approved)/
Regulatory Authorities USFDA Approved
Me-too status X-plended of M/s Pharmevo Pakistan
Decision: Approved
Brand Name + Dosage Form + Strength Cilovas tablet 50mg
Cilostazol .……..50mg
Pharmacological Group Anti-thrombotic agent
Me-too status Walk-Aid of M/s Werrick Pharmaceuticals
Remarks of the Evaluator ● Boxed warning shows contraindication in heart failure
patients.
Decision: Approved with box warning.
Brand Name + Dosage Form + Strength Cilovas tablet 100mg
Cilostazol .………………..100mg
Pharmacological Group Anti-thrombotic agent
Me-too status Walk-Aid of M/s Werrick Pharmaceuticals
patients.
Brand Name + Dosage Form + Strength Onsetron tablet 8mg
Composition Each orally disintegrated tablet contains:
Ondansetron HCl ……….……………………...8mg
Pharmacological Group Anti-emetic and anti-nauseant
Me-too status Oniron of M/s Genome Pharmaceuticals
patients.
Brand Name + Dosage Form + Strength Sevelam tablet 400mg
Sevelamer HCl.……………………...............400mg
Pharmacological Group Drugs for treatment of Hyperkalemia and Hyperphosphatemia
Me-too status Renavel 400mg of M/s Genome Pharmaceuticals
Brand Name + Dosage Form + Strength Sevelam tablet 800mg
Sevelamer HCl.……………………...............800mg
Pharmacological Group Drugs for treatment of Hyperkalemia and Hyperphosphatemia
Me-too status Renavel 800mg tablet of M/s Genome Pharma (Reg. #
075510)
Brand Name + Dosage Form + Strength Lamogine tablet 25mg
Lamotrigine…………………….......................25mg
Approval status of product in Reference Lamictal of M/s GSK Pharmaceuticals, UK (MHRA
Me-too status Lojin tablet 25mg of M/s Hilton Pharmaceuticals
Lamotrigine…………………….......................50mg
Lamotrigine…………………….......................100mg
Brand Name + Dosage Form + Strength Cinapro tablet 250mg
Naproxen …………………….......................250mg
Me-too status Dolonap tablet 250mg of M/s Platinum Pharma
Decision: Approved
Brand Name + Dosage Form + Strength Cinapro tablet 500mg
Naproxen …………………….......................500mg
Me-too status Dolonap tablet 500mg of M/s Platinum Pharma
Decision: Approved
203. Name and address of manufacturer / M/s Kaizen Pharmaceuticals (Pvt) limited, E-127-129,
Applicant North Western Industrial Zone, Bin Qasim, Karachi
Brand Name + Dosage Form + Strength Cinapro EC tablet 500mg
Naproxen………….......................500mg
Me-too status Dolonap tablet of M/s Platinum Pharma
the report concludes renewal of DML.
Decision: Approved
Brand Name + Dosage Form + Strength Spirone tablet 25mg
Eplerenone …………………….......................25mg
Pharmacological Group Diuretics
Finished product Specification Innovators‘ specifications
Me-too status Epliron of M/s Highnoon
available in J.P.
Decision: Deferred for confirmation of manufacturing facility for Tablet (Steroid) Section.
Brand Name + Dosage Form + Strength Spirone tablet 50mg
Eplerenone …………………….......................50mg
Diary No. Date of R& I & fee Dy. No. 4151 29-05-2017; Rs.20,000/- (19-05-2017)
Pharmacological Group Diuretics

Finished product Specification Innovators‘ specifications
Me-too status Epliron of M/s Highnoon
available in J.P.
Decision: Deferred for confirmation of manufacturing facility for Tablet (Steroid) Section.
Brand Name + Dosage Form + Strength Oxapine tablet 300mg
Oxcarbazepine...…………….......................300mg
Diary No. Date of R& I & fee Dy. No. 4147 29-05-2017; Rs.20,000/- (19-05-2017)
Finished product Specification USP specifications
Me-too status Telox tablet 300mg of M/s Platinum
Decision: Approved
Brand Name + Dosage Form + Strength Oxapine tablet 600mg
Oxcarbazepine...…………….......................600mg
Me-too status Telox tablet 600mg of M/s Platinum Pharmaceuticals
Decision: Approved
Brand Name + Dosage Form + Strength Aripra tablet 5mg
Aripiprazole...………………..............................5mg
Me-too status Ariza tablet 5mg of M/s Hilton Pharmaceuticals
Remarks of the Evaluator ● Boxed warning of suicidal thoughts.
Aripiprazole...………………..............................10mg
Me-too status Aripip 10mg of M/s Pharmatec
Remarks of the Evaluator ● Boxed warning of suicidal thoughts and increased risk
of death in dementia-related psychosis.
Aripiprazole...………………..............................15mg
Me-too status Aripip 15mg of M/s Pharmatec
Remarks of the Evaluator ● Boxed warning of suicidal thoughts and increased risk
of death in dementia-related psychosis.
Brand Name + Dosage Form + Strength Divalpro tablet 250mg
Divalproex Sodium eq. to Valproic Acid..........250mg
Pharmacological Group Anticonvulsants & Anti-epileptics
Me-too status Epival tablet 250mg of M/s Abbott Laboratories
(Reg. # 007160)
Remarks of the Evaluator ● Boxed warning shows life threatening adverse
reactions like fatal hepatotoxicity, pancreatitis,
congenital malformations, particularly neural tube
defects etc.
Brand Name + Dosage Form + Strength Divalpro tablet 500mg
Divalproex Sodium eq. to Valproic Acid..........500mg
Pharmacological Group Anticonvulsants & Anti-epileptics
Approval status of product in Reference Divalproex Sodium delayed-release tablet (USFDA
Me-too status Epival tablet 500mg of M/s Abbott Laboratories
(Reg. # 007161)
Remarks of the Evaluator ● Boxed warning shows life threatening adverse
reactions like fatal hepatotoxicity, pancreatitis,
congenital malformations, particularly neural tube
defects etc.
Brand Name + Dosage Form + Strength Cyclopen capsules 15mg
Composition Each SR capsule (pellets) contains:
Cyclobenzaprin HCl (as sustained-release
pellets)……………………………. 15mg
Type of Form Form-5
Approval status of product in Reference Amrix capsules 15mg of M/s Teva Pharmaceuticals (USFDA
Me-too status Amrix capsules 15mg of M/s Getz Pharma, Pakistan

Remarks of the Evaluator ● Source of pellets is M/s Vision Pharma.
● CoA of manufacturer is provided.
● GMP certificate of the manufacturer is provided.
● Stability data of pellets have been submitted.
Decision: Approved.
Brand Name + Dosage Form + Strength Vios capsule 20mg
Composition Each delayed release capsule (enteric-coated pellets) contains:
Esomeprazole Magnesium Trihydrate eq. to
Esomeprazole………………………...20mg
Pharmacological Group Proton Pump Inhibitor (Anti-peptic Ulcerant)
Pack size & Demanded Price 14‘s & Rs.25 per capsule
Approval status of product in Reference Nexium capsule of M/s Astra Zeneca (USFDA Approved)
Me-too status Nexum 20mg capsule of M/s Getz Pharma(Pvt) ltd, Pak
Remarks of the Evaluator ● Source of pellets is M/s Vision Pharma, Industrial
Triangle, Kahuta Road, Islamabad.
● GMP certificate of the manufacturer of pellets is
provided
● Stability data of pellets is provided.
Decision: Approved.
Brand Name + Dosage Form + Strength Vios capsule 40mg
Composition Each delayed release capsule (enteric-coated pellets) contains:
Esomeprazole Magnesium Trihydrate eq. to
Esomeprazole………………………...40mg
Pharmacological Group Proton Pump Inhibitor (Anti-peptic Ulcerant)
Pack size & Demanded Price 14‘s & Rs. 32.14 per capsule
Approval status of product in Reference Nexium capsule of M/s Astra Zeneca (USFDA Approved)
Me-too status Nexum 40mg capsule of M/s Getz Pharma(Pvt) ltd, Pak
Remarks of the Evaluator ● Source of pellets is M/s Vision Pharma, Industrial
Triangle, Kahuta Road, Islamabad.
● GMP certificate of the manufacturer of pellets is
provided
● Stability data of pellets is provided
Decision: Approved.
216. Name and address of manufacturer / M/s UDL Pharmaceuticals, Plot # E-44 & E-45, North
Applicant Western Industrial Zone, Port Qasim Authority, Karachi
Brand Name + Dosage Form + Strength Xavarox tablet 2.5mg

Rivaroxaban ……………2.5mg
Pharmacological Group Anticoagulant
Pack size & Demanded Price 10‘s & as per PRC
Me-too status Xarelto of M/s Baeyer Pharmaceuticals
report concludes resumption of production operations
accordingly.
Brand Name + Dosage Form + Strength Xavarox tablet 10mg
Rivaroxaban ……………10mg
Me-too status Xcept of M/s Pharm-evo Pharmaceuticals
accordingly.
Rivaroxaban …………….15mg
Me-too status Xcept of M/s Pharm-evo Pharmaceuticals
accordingly.

Rivaroxaban ……………20mg
Me-too status Xcept of M/s Pharm evo Pharmaceuticals
accordingly.
Brand Name + Dosage Form + Strength Relivetan capsule 20mg
Isotretinoin ………………………20mg
Pharmacological Group Retinoids for topical use in acne
Me-too status Isotop of M/s Wisdom Pharmaceuticals
(Reg. # 054948)
accordingly.
Brand Name + Dosage Form + Strength Tritrop Rota capsule 0.18mcg
Composition Each rota capsule contains:
Tiotropium Bromide Monohydrate...………0.18mcg
Pharmacological Group Anticholinergic/ Bronchodilator
Approval status of product in Reference Approved in USFDA in 1.25mcg, 2.5mcg and 18mcg
Me-too status Tiovair 18mcg of M/s Highnoon Laboratories
(Reg. # 054315)
accordingly.
Remarks of the Evaluator ●
The applied formulation is not available
internationally and locally in the applied strength i.e.
0.18mcg.
Brand Name + Dosage Form + Strength Itotec tablet 50mg
Itopride HCl...………………………………...50mg
Pharmacological Group Propulsive
Approval status of product in Reference Ganaton of M/s Abbott Laboratories (PMDA) Japan
Regulatory Authorities Approved
Me-too status ITP of M/s Sami Pharmaceuticals
accordingly.
Brand Name + Dosage Form + Strength Itotec tablet 150mg
Itopride HCl...………………………………..150mg
Pharmacological Group Propulsive
Approval status of product in Reference Ganaton of M/s Abbott Laboratories (PMDA) Japan
Regulatory Authorities Approved
Me-too status ITP OD of M/s Sami Pharmaceuticals
accordingly.
Evaluator PEC-IV
224. Name and address of manufacturer / M/s Gulf Pharmaceuticals Plot # 49 street-5, National
Applicant Industrial zone Rawat Islamabad,
Brand Name +Dosage Form + Strength Tams-G 0.4mg Capsule
Tamsulosin HCl (modified release pellets eq to
Tamsulosin……….0.4mg
Diary No. Date of R& I & fee Dy.No.2686; 24-02-2017; Rs.20,000/- (24-02-2017)
Pharmacological Group Alpha blocker
Type of Form Form 5

Finished product Specifications Manufacturer specification
Pack size & Demanded Price 1x 10‘s ; As per SRO
Approval status of product in Reference Contiflo xl capsule of (MHRA approved)
Me-too status (with strength and dosage Alfamax capsule M/s Platinum Pharmaceuticals,
form)
GMP status Last GMP inspection conducted on 25-05-2017 ,and the report
concludes that panel recommended the resumption of
production activity.
Remarks of the Evaluator ● The official monograph of the product is available in USP
● Source of pellets: Vision Pharmaceuticals
225. Name and address of manufacturer / M/S Fredmann Pharmaceuticals Plot # 82-83 B, Old Industrial
Applicant Area Mirpur, Azad Kashmir
Brand Name +Dosage Form + Strength Bresco 5mg Chewable Tablet
Composition Each chewable tablet contains:
Montelukast as (sodium)……5mg
Pharmacological Group Leukotriene receptor antagonist
Type of Form Form 5
Pack size & Demanded Price 2 x 7‘s ; As per SRO
Approval status of product in Reference Singulair 5mg chewable of (USFDA approved)
Me-too status (with strength and dosage Lontuka 5mg Chewable Tablet M/s Linz Pharmaceuticals.
form)
GMP status Last GMP inspection conducted on 24-11-2017 ,and the
report concludes that firm was at fair level of GMP
Remarks of the Evaluator Firm changed the formulation from film coated to chewable tablet.
Decision: Deferred for submission of fee for revision of formulation
226. Name and address of manufacturer / M/S Pakistan Pharmaceuticals products (Pvt) Ltd. D- 122,
Applicant Sindh Industries Trading estate, Karachi,
Brand Name +Dosage Form + Strength No- Uric 80mg tablet
Febuxostat……..80mg
Pharmacological Group Antigout preparation(Non-purine xanthine oxidase Inhibitor)
Type of Form Form 5
Approval status of product in Reference Uloric 80mg Tablet of (USFDA approved)
Me-too status (with strength and dosage Febuxin 80mg Tablet of M/s AGP
form)
report concludes that firm overall ratings is GOODF
Decision: Approved with innovator’s specification
Brand Name +Dosage Form + Strength No- Uric 40mg tablet
Febuxostat……..40mg

Pharmacological Group Antigout preparation(Non-purine xanthine oxidase Inhibitor)
Type of Form Form 5
Approval status of product in Reference Uloric 40mg Tablet of (USFDA approved)
Me-too status (with strength and dosage Febuxin 40mg Tablet of M/s AGP
form)
report concludes that firm overall ratings is GOOD
Brand Name +Dosage Form + Strength Remember 10mg tablet
Memantine as(HCl)……..10mg
Pharmacological Group NMDA Receptor Antagonist
Type of Form Form 5
Approval status of product in Reference Memantine 10mg Tablet of (USFDA approved)
Me-too status (with strength and dosage Namentec 10mg Tablet of M/s Pharmatec
form)
report concludes that firm overall ratings is GOOD
Decision: Approved
229. Name and adAdress of manufacturer / M/S Getz Pharma Pvt Ltd, 29-30/27,Korangi B Industrial
Applicant Area, Karachi,Pakistan
Contract Manufactured By: M/S Novamed Pharmaceuticals
(Pvt) Ltd, , 28th Km Ferozepur Road, Lahore.
Brand Name +Dosage Form + Strength Bivaclor 250mg Capsule
Composition Each Capsule contains:
Cefaclor as (monohydrate) eq to cefaclor……….250mg
Type of Form Form 5
Pack size & Demanded Price 12‘s ; RS; 350/
Approval status of product in Reference Keftid Capsules 250mg Of (MHRA approved)
Me-too status (with strength and dosage Sac-Lor 250mg Capsule M/s Semos Pharma
form)
GMP status Last GMP inspection of Getz Pharma is conducted on 05-
07-2017 and the report concludes that firm was operating at
an acceptable level compliance of GMP
Last GMP inspection of NovaMed Pharma conducted
on 05 & 12 Dec, 2017 and report concludes compliant to
Good cGmp guidelines
Decision: Approved.

230. Name and address of manufacturer / M/S Getz Pharma Pvt Ltd, 29-30/27,Korangi B Industrial
Applicant Area, Karachi, Pakistan
Brand Name +Dosage Form + Strength Bivaclor 500mg Capsule
Cefaclor as (monohydrate) Eq to Cefaclor……….500mg
Type of Form Form 5
Pack size & Demanded Price 12‘s ; RS; 600/
Approval status of product in Reference Keftid Capsules 500mg Of (MHRA approved)
Me-too status (with strength and dosage Sac-Lor 500mg Capsule M/s Semos Pharma
form)
Last GMP inspection of NovaMed Pharma conducted on 05
& 12 Dec, 2017 and report concludes compliant to Good
cGmp guidelines
Decision: Approved
Brand Name +Dosage Form + Strength Bivaclor 50mg/ml Drops
Type of Form Form 5
Pack size & Demanded Price 15ml ; RS; 100/
Approval status of product in Reference Distaclor 250mg/5ml Of (MHRA approved)
Me-too status (with strength and dosage Plozat Dry Powder Drops 50mg M/s Wisdom
GMP status
Last GMP inspection of Getz Pharma is conducted on 05-07-
2017 and the report concludes that firm was operating at an
acceptable level compliance of GMP
Last GMP inspection of NovaMed Pharma conducted on 05

& 12 Dec, 2017 and report concludes compliant to Good
cGmp guidelines
Decision: Approved
Brand Name +Dosage Form + Strength Bivaclor 125/5ml Suspension

Type of Form Form 5
Me-too status (with strength and dosage Plozat Dry Powder for suspension 125mg M/s Wisdom
Decision: Approved
Brand Name +Dosage Form + Strength Bivaclor 250mg/5ml Suspension
Type of Form Form 5
Me-too status (with strength and dosage Plozat Dry Powder for suspension 250mg M/s Wisdom
Decision: Approved
234. Name and address of manufacturer / M/S Nabiqasim Industries (Pvt) Ltd., 17/24, Korangi ,
Applicant Industrial Area, Karachi, Pakistan
Brand Name +Dosage Form + Strength Optilac Ophthalmic solution 0.5%Sterile
Ketrolac tromethamine USP……..5mg
Type of Form Form 5
Pack size & Demanded Price 5ml ; As per PRC
Approval status of product in Reference Acular 0.5% ophthalmic solution of ( USFDA approved)

Me-too status (with strength and dosage Optiket 0.5 % Eye Drops of M/s Winthrox
form)
GMP status Last GMP Inspection conducted on 02-11-2017 and
report concludes that firm is found good level of GMP
compliance.(PSI)
235. Name and address of manufacturer / M/S Aspin Pharma (Pvt) Ltd., Plot No. 10 & 25. Sector 20,
Applicant Korangi Industrial Area, Karachi, Pakistan
Brand Name +Dosage Form + Strength Clobiotic (1%w/w) Cream
Composition Each gm of cream contains:
Clotrimazole ……..10mg (1% w/w)
Pharmacological Group Azole Antifungal
Type of Form Form 5
Pack size & Demanded Price 10gm x 1‘s ; As per DPC
Approval status of product in Reference Clotrimazole 1% Cream of ( USFDA approved)
Me-too status (with strength and dosage Dermofit 1% Cream of M/s Baxter
form)
report concludes that firm is operating at satisfactory level of
GMP compliance.
Remarks of the Evaluator ● Alternate Brands
1. Calcrem
2. Trimzol
Decision: Approved
Brand Name +Dosage Form + Strength Clobiotic-H (1%w/w) Cream
Composition Each gm of cream contains:
Clotrimazole ……..10mg (1% w/w)
Hydrocortisone as (acetate) 11.2 mg Eq to
Hydrocortisone……..10mg (1% w/w)
Pharmacological Group Azole Antifungal,Corticosteriod
Type of Form Form 5
Finished product Specifications Manufacturer‘s Specification
Approval status of product in Reference Canesten HC Cream of (MHRA approved)
Me-too status (with strength and dosage Hyzol Cream of M/s Meditech Pharmaceuticals
form)
GMP compliance.
1. Calcrem- H
2. Trimzol- H
Brand Name +Dosage Form + Strength Impecin (2%w/w) Ointment
Composition Each gm of ointment contains:
Mupirocin ……..20mg (2% w/w)
Pharmacological Group Topical antibiotic
Type of Form Form 5
Approval status of product in Reference Centany ointment of (USFDA approved)
Me-too status (with strength and dosage Mupiderm Ointment of M/s Tabros Pharma,
form)
GMP compliance..
1. Impetan
2. Mutoban
Decision: Approved
238. Name and address of manufacturer / M/S Sami Pharmaceuticals (Pvt) Ltd., F-95, S.I.T.E, Karachi,
Applicant Pakistan.
Brand Name +Dosage Form + Strength Roquin (2%w/w) Cream
Composition Each 100gm of Cream contains:
Hydroquinone ……..2g (2% w/w)
Pharmacological Group Depigmenting Agent
Type of Form Form 5
Pack size & Demanded Price 10gm, 15gm, 20gm ; As per DPC
Approval status of product in Reference Symba Skin Toner 2% Cream of (MHRA approved)
Me-too status (with strength and dosage Hydroderm Cream 2% of M/s Werrick Pharmaceuticals
form)
report concludes that firm is operating at Good level of GMP
compliance .
Decision: Approved
239. Name and address of manufacturer / M/S Sami Pharmaceuticals (Pvt) Ltd., F-95, S.I.T.E, Karachi,
Applicant Pakistan.
Brand Name +Dosage Form + Strength Roquin (4%w/w) Cream
Composition Each 100gm of Cream contains:
Hydroquinone ……..4g (4% w/w)
Pharmacological Group Depigmenting Agent
Type of Form Form 5
Pack size & Demanded Price 10gm, 15gm, 20gm ; As per DPC
Approval status of product in Reference Corrector 4% Cream of (Health Canada approved)
Me-too status (with strength and dosage Hydroderm Cream 4% of M/s Werrick Pharmaceuticals
form)
report concludes that firm is operating at Good level of GMP
compliance
240. Name and address of manufacturer / M/S High –Q Pharmaceuticals, Plot No ; 224/23 Korangi
Applicant Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Metadine 100mg tablet
Amantadine sulphate……….100mg
Pharmacological Group Anti-viral
Type of Form Form 5
Pack size & Demanded Price 10‘s, 20‘s, 30‘s, ; As per leader price
Approval status of product in Reference Germany approved
Me-too status (with strength and dosage Parkin 100mg Tablet M/s Helix Pharma
form)
GMP status Last GMP inspection was conducted on 19-07-2017
and the report shows grant of GMP certificate.
Brand Name +Dosage Form + Strength Fucinex (2%w/w) Cream
Composition Each gm of Cream contains:
Fusidic Acid ……..20mg (2% w/w)
Pharmacological Group Anti-bacterial
Type of Form Form 5
Approval status of product in Reference Fucidin cream of (MHRA approved)
Me-too status (with strength and dosage Hifuzin Cream of M/s Hiranis
form)
GMP compliance.
1. Fortison
2. Fusitin
Decision: Approved
Evaluator PEC-VII
242. Name and address of manufacturer / Medisynth Pharmaceuticals (Pvt.) Ltd. Plot No. 55, Street S-5,
Applicant NIZ, Rawat, Islamabad, Pakistan .
Brand Name +Dosage Form + Strength Tirasynth 250mg Tablet USP
Levetiracetam….250mg
Diary No. Date of R& I & fee Dy. No.752; 27-04-2017; Rs.20,000/-
Type of Form Form 5
Pack size & Demanded Price 3x10; As per PRC
Approval status of product in Reference KEPPRA by UCA inc (USFDA)
Me-too status (with strength and dosage Keppra Tablets 250mg by M/s AGP (Pvt.) Ltd,
form) Karachi (Reg. No. 045684)
GMP status Last inspection conducted on 5-10-2017 for renewal of DML.
Decision: Approved.
243. Name and address of manufacturer / Medisynth Pharmaceuticals (Pvt.) Ltd. Plot No. 55, Street S-5,
Applicant NIZ, Rawat, Islamabad, Pakistan .
Brand Name +Dosage Form + Strength Terbicid 250mg Tablets
Terbinafine as HCl……..250mg
Type of Form Form 5
Approval status of product in Reference Lamisil Tablets 250mg by Novartis Pharmaceuticals UK
Regulatory Authorities Ltd.(MHRA approved)
Me-too status (with strength and dosage Lamisil Tablets 250mg by Novartis
form)
Decision: Approved.
244. Name and address of manufacturer / Medisynth Pharmaceuticals (Pvt.) Ltd.
Applicant Plot No. 55, Street S-5, NIZ, Rawat, Islamabad, Pakistan .
Brand Name +Dosage Form + Strength Bilcid 250mg Capsule

Ursodeoxycholic acid….250 mg
Diary No. Date of R& I & fee Dy. No.663; 02-05-2017; Rs.20,000/-(02-05-2017)
Pharmacological Group Dihydroxy bile acids, Gall stone solubilizing agent
Type of Form Form 5
Approval status of product in Reference Ursofalk 250mg Capsule in UK (MHRA)
Me-too status (with strength and dosage Urso 250mg capsules by AGP
form)
Decision: Approved
Applicant Plot No. 55, Street S-5, NIZ, Rawat, Islamabad, Pakistan.
Brand Name +Dosage Form + Strength Bilcid 500mg Capsule

Ursodeoxycholic acid….500 mg
Pharmacological Group Dihydroxy bile acids, Gall stone solubilizing agent
Type of Form Form 5
Approval status of product in Reference Ursochol 500 mg capsule, hard
Regulatory Authorities By Orifarm Generics A/S (Sweden)
Me-too status (with strength and dosage Urso 500mg capsules by AGP
form)
Decision: Approved.
Brand Name +Dosage Form + Strength FAXIT XR 50mg

Desvenlafaxine succinate eq 50mg base ……..50mg
Type of Form Form 5
Finished product Specifications Innovator
Approval status of product in Reference Pristiq of Wyeth (USFDA)
Me-too status (with strength and dosage Lafaxine by Genix
form)
Brand Name +Dosage Form + Strength FAXIT XR 100mg

Desvenlafaxine succinate eq base ……..100 mg
Type of Form Form 5
Finished product Specifications Innovator
Approval status of product in Reference Pristiq of Wyeth (USFDA)
Me-too status (with strength and dosage Lafaxine by Genix
form)
Decision: Approved with change of brand name and as per Innovators specifications.
Brand Name +Dosage Form + Strength Clozip 250mg Tablets

Azithromycin dihydrate eq to Azithromycin…..250mg
Type of Form Form 5
Approval status of product in Reference Azithromycin 250 Mg Film-Coated Tablets (MHRA)
Me-too status (with strength and dosage Azomax tablets by Novartis
form)
Decision: Approved
Brand Name +Dosage Form + Strength Clozip 500mg Tablets
Azithromycin dihydrate eq to Azithromycin…..500mg
Type of Form Form 5
Approval status of product in Reference Azithromycin 500 mg Film-Coated Tablets (MHRA)
Me-too status (with strength and dosage Azomax tablets by Novartis
form)
Decision: Approved

Brand Name +Dosage Form + Strength Nimosyn 30mg Tablets
Nimodipine………..30mg
Pharmacological Group Calcium channel blocker
Type of Form Form 5
Approval status of product in Reference Nimotop tablets by Bayer
Me-too status (with strength and dosage Nimoden tablet HIGH Q
form)
Decision: Approved.
Brand Name +Dosage Form + Strength Dopa 1mg Tablets
Composition Each film coated tablet contains:-
Ropinirole (as hydrochloride)… 1mg
Pharmacological Group Anti-Parkinson/ Dopamine agonist
Type of Form Form 5
Approval status of product in Reference Requip by Gaxosmithkline (USFDA)
Me-too status (with strength and dosage Propinol by Shrooq Pharma
form)
Brand Name +Dosage Form + Strength Dopa 2mg Tablets
Ropinirole (as hydrochloride)… 2mg
Pharmacological Group Anti-Parkinson/ Dopamine agonist
Type of Form Form 5
Approval status of product in Reference Requip by Gaxosmithkline (USFDA),
Me-too status (with strength and dosage Propinol by Shrooq Pharma
form)
Brand Name +Dosage Form + Strength DIPVAL Tablets USP
Amlodipine (as Besylate)…………5 mg
Valsartan…………..160 mg
Pharmacological Group Calcium Channel Blocker, Angiotensin Receptor Blocker
Type of Form Form 5
Approval status of product in Reference Exforge by Novartis Pharma GmbH, (USFDA))
Me-too status (with strength and dosage Exforge. By Novartis (R. No. 047570)
form)
Brand Name +Dosage Form + Strength Olanzo 10mg Tablets
Olanzapine………10 mg
Diary No. Date of R& I & fee Dy. No.;766, 27-04-2017; Rs.20,000/-
Pharmacological Group Dopamine Antagonist ( Antipsychotics)
Type of Form Form 5
Pack size & Demanded Price 1x10,; As per PRC
Approval status of product in Reference Olanzapine of Accord UK MHRA)
Me-too status (with strength and dosage Furmium by Indus Pharmaceuticals
form)
Brand Name +Dosage Form + Strength STROGEN 50mg Tablet USP
Composition Each tablet contains:-
Clomiphene Citrate…..50mg
Pharmacological Group A non-steroidal ovulary stimulant
Type of Form Form 5
Approval status of product in Reference Clomid 50mg Tablets by M/s Sanofi , MHRA approved
Me-too status (with strength and dosage Ovafin 50 mg tablet by M/s OBS (Reg#019173)
form)
Remarks of the Evaluator Registration Board decided in previous meetings to grant
registration of above applied product in general manufacturing
areas with condition that manufacturer shall provide safety
and protective measures for workers and personnel which
remain in direct contact or are involved in close handling of
these drugs.
Registration Board approved registration of product in general manufacturing areas with condition
that manufacturer shall provide safety and protective measures for workers and personnel which
remain in direct contact or are involved in close handling of these drugs.
Brand Name +Dosage Form + Strength SYCOSIN 200mg Tablets
Composition Each Film Coated Tablet Contains

Quetiapine (as fumarate)…………..200mg
Diary No. Date of R& I & fee Dy. No.753; 27-04-2017; Rs.20,000/
Pharmacological Group Anxiolytic Sedatives Hypnotics and Antipsychotics.
Type of Form Form 5
Pack size & Demanded Price 3x10‘s, As per PRC
Approval status of product in Reference Quetiapine 200 mg Film-coated Tablets (MHRA)
Me-too status (with strength and dosage Evokalm 200mg tablet by Pharmevo
form)
Decision: Approved.

Type of Form Form 5
Approval status of product in Reference Quetiapine Fumarate (USFDA)
form)

Decision: Approved.

Type of Form Form 5
Approval status of product in Reference Quetiapine Fumarate (USFDA)
form)
Decision: Approved.
Brand Name +Dosage Form + Strength Verteg 24mg Tablets
Composition Each Tablet Contains
Betahistine dihydrochloride…..24 mg
Pharmacological Group Anti vertigo.
Type of Form Form 5
Approval status of product in Reference Betahistine 24 mg uncoated tablets by M/s Milpharm
Regulatory Authorities Ltd (MHRA Approved)
Me-too status (with strength and dosage Enier 24mg Tablets by M/s SAMI
form)
Decision: Approved.
Brand Name +Dosage Form + Strength Verteg 8mg Tablets
Composition Each Tablet Contains
Betahistine dihydrochloride…..8 mg
Pharmacological Group Anti-vertigo.
Type of Form Form 5
Approval status of product in Reference Betahistine 8 mg uncoated tablets by M/s Milpharm Ltd
Me-too status (with strength and dosage Deperin of Focous & Rulz
form)
Decision: Approved.
Brand Name +Dosage Form + Strength VORCON 200mg Tablets
Voriconazole………200mg
Type of Form Form 5
Finished product Specifications JP
Approval status of product in Reference Voriconazole 200 mg film-coated tablets (MHRA)
Me-too status (with strength and dosage Vorif of Ferozsons Laboratories Ltd
form)
Decision: Approved.
262. Name and address of manufacturer / M/s Linta Pharmaceuticals, Plot # 3, st S-5, Rawat industrial
Applicant estate, Islamabad
Brand Name +Dosage Form + Strength Acer cream
Composition Each gm contains:
Fluconazole acetonide.. …… 0.01%
Hydroquinone …… 4%
Tretinoin …… 0.05%
Diary No. Date of R& I & fee Dy. No.782; 9-1-2017; Rs. 20,000/-
Pharmacological Group Antifungal /Anti acne
Type of Form Form-5
Finished product Specifications Innovators
Pack size & Demanded Price 30 g
As per SRO
Approval status of product in Reference TRI-LUMA® Cream (USFDA)
Me-too status Retrieve by Mass Pharma

GMP status Last GMP Inspection dated 8-6-017 with conclusive remarks
of cGMP compliance.
Brand Name +Dosage Form + Strength Velo dry powder suspension 250 mg

Cephradine ….250 mg
Type of Form Form-5
Pack size & Demanded Price 60 ml
As per SRO
Approval status of product in Reference Cefradine powder for Syrup 250mg/5ml (UK-MHRA)
Me-too status AG-Ceph 250mg/5ml of M/s Saydon Pharmaceuticals.

of cGMP compliance.
Decision: Approved.
Brand Name +Dosage Form + Strength Velo dry powder suspension 125 mg

Cephradine….125 mg
Type of Form Form-5
Approval status of product in Reference VELOSEF '125' of Apothecon (USFDA) ―Discontinued‖
Me-too status Velosef of GSK

of cGMP compliance.
265. Name and address of manufacturer / M/s Wenovo Pharmaceuticals, Taxila
Applicant
Brand Name +Dosage Form + Strength Tinilex 4mg Tablet
Tizanidine (as hydrochloride)……….4mg
Pharmacological Group Alpha-2 receptor antagonist/muscle relaxant
Type of Form Form-5
Finished product Specification USP specification
Pack size & Demanded Price 10‘s, 20‘s; As per SRO
Approval status of product in Reference Tizanidine by Actavis UK
Me-too status Movax by Sami

GMP status Last inspection conducted on 19-10-2017 and report
concludes that firm is found complying GMP as of today.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Tinilex 2 mg Tablet
Tizanidine as HCl… 2mg
Pharmacological Group Muscle Relaxants, Centrally Acting Agents
Type of Form Form-5
Pack size & Demanded Price 1 x 10‘s
As per PRC
Approval status of product in Reference Tizanidine 2mg uncoated Tablets Actavis UK Ltd (MHRA)
Me-too status Analar by AGP

Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Lacsim 100 mg Tablet

Lacosamide …………………100mg
Type of Form Form-5
Pack size & Demanded Price As per SRO & Rs.560/14‘s
Approval status of product in Reference Lacosamide Teva 100 mg Film-coated Tablets (MHRA)

Applicant
Brand Name +Dosage Form + Strength Lacsim 50 mg Tablet

Lacosamide …………………50mg
Type of Form Form-5
Finished product Specification Innovators
Pack size & Demanded Price As per SRO & Rs.560/14‘s
Approval status of product in Reference LACOSAMIDE GLENMARK 50MG FILM-COATED
Regulatory Authorities. TABLETS (MHRA)
Me-too status Lalap 50 mg tablet of M/s Genix Pharma

Remarks of the Evaluator. No USP or BP monograph is available for applied formulation
Decision:
Applicant
Brand Name +Dosage Form + Strength Provair 10mg Tablet

Montelukast (as sodium)…10mg
Diary No. Date of R& I & fee Dy. No 1450; 3-05-2017; Rs.20,000/-
Type of Form Form 5
Pack size & Demanded Price 10‘s
As per SRO
Approval status of product in Reference Montelukast 10 mg film-coated tablets by M/s Accord
Regulatory Authorities. Healthcare Limited (MHRA approved)
Me-too status Montiget 10 mg tablet by M/s Getz Pharma (Reg#034838)

Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Rabezol 20 mg capsule

Rabeprazole sodium enteric coated pellets (8.5%) eq to
Rabeprazole…….. 20mg
Diary No. Date of R& I & fee Dy No.1443; 3-05-2017; Rs.20,000/-
Pharmacological Group Proton pump inhibitors
Type of Form Form 5
Finished product Specification Innovator
Pack size & Demanded Price 2x7‘s / As per SRO
Approval status of product in Reference NA
Me-too status NA
regulatory authorities/agencies which were declared/approved
by the Registration Board.
Evidence of applied formulation/drug already approved by
DRAP (generic / me-too status) alongwith registration
number, brand name and name of firm.
· 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 declared/approved by the Registration Board

Applicant
Brand Name +Dosage Form + Strength Gemiflox 320 mg Tablet
Gemifloxacin (as mesilate)… 320 mg
Type of Form Form-5
Pack size & Demanded Price 1x7‘s/ As per PRC
Approval status of product in Reference GEMIFLOXACIN MESYLATE (USFDA)
Me-too status Gemwel 320mg tablet of welmark pharmaceuticals

Applicant
Brand Name +Dosage Form + Strength Sitaformin 50/500mg Tablet
Sitagliptin(as phosphate monohydrate)……50mg
Metformin HCl……500mg
Pharmacological Group Dipeptidyl Peptidase inhibitor and Biguanide
Type of Form Form-5
Finished product Specification Manufacturer‘s
Approval status of product in Reference Janumet 50mg/500mg Tablets by M/s Merck
Regulatory Authorities. (USFDA approved)
Me-too status Duvel Plus 50mg/500mg Tablet by M/s Martin Dow
Applicant
Brand Name +Dosage Form + Strength Sitaformin 50/1000 mg Tablet
Sitagliptin(as phosphate monohydrate)……50mg
Metformin HCl……1000mg
Pharmacological Group Dipeptidyl Peptidase inhibitor and Biguanide
Type of Form Form-5
Approval status of product in Reference Janumet50mg/1000mg Tablets by M/s Merck
Me-too status Duvel Plus 50mg/1000mg Tablet by M/sMartin Dow
pharmaceuticals
Applicant
Brand Name +Dosage Form + Strength Novomate 50mg Tablet
Topiramate………...............50mg
Type of Form Form-5
Pack size & Demanded Price 3x10‘s; As recommended by the PRC
Approval status of product in Reference Topamax (USFDA approved)
Me-too status Tics 50mg tablets of M/s Genix pharma

Decision: Approved.
275. Name and address of the M/s Genetics Pharmaceuticals (Pvt.) Ltd.
manufacturer/Applicant 539-A, Sundar Industrial Estate, Raiwind Lahore
Brand Name +Dosage Form + Strength Cetralex 25mg Tablet

Sertraline (as Hydrochloride)….25mg
Diary No. Date of R&I & Fees Dy No.1154; 02-5-2017; Rs.20,000/-
Pharmacological Group Selective Serotonin Reuptake Inhibitor
Type of Form Form – 5
Finish Product Specification USP
Pack size & Demanded price 10‘s,14‘s,20‘s,28‘s / As per SRO
Approval Status of product in Reference Sertraline Hydrochloride 25mg Tablet By M/s Oxford
Regulatory Authorities Pharms, Approved By USFDA
Me – too Status NA
GMP Status GMP dated 12-2-2018, the GMP compliance status of firm
can‘t be verified because firm was not operational at the time
of inspection however premises were found well maintained
and at satisfactory level.
Remarks of Evaluator Evidence of me-too is missing.
Brand Name +Dosage Form + Strength Aripra 5mg tablet
Aripiprazole …5mg
Diary No. Date of R&I & Fees Dy no.1159, 2-5-2018, Rs.20,000/-
Pharmacological Group Antipsychotics
Approval Status of product in Reference Abilify 5mg Tablet by M/s Otsuka Pharmaceutical, Approved
Regulatory Authorities by USFDA
Me – too Status Biponil 5mg Tablet by M/s Werrick Pharmaceuticals
Decision: Approved.
Brand Name +Dosage Form + Strength Aripra 15mg Tablet

Aripiprazole …15mg
Diary No. Date of R&I & Fees Dy No.1161, 2-5-18 ; Rs.20,000/-
Approval Status of product in Reference Abilify 15mg Tablet by M/s Otsuka Pharmaceutical,
Regulatory Authorities Approved by USFDA

Decision: Approved.

Diary No. Date of R&I & Fees Dy no.1162; 2-5-17 Rs.20,000/-
Me – too Status Biponil 10mg by M/s Werrick Pharmaceuticals

Decision: Approved.

Aripiprazole …2mg
Diary No. Date of R&I & Fees Dy no.;1158, 2-5-18 Rs.20,000/-
Approval Status of product in Reference Abilify 2mg Tablet by M/s Otsuka Pharmaceutical, Approved
Remarks of Evaluator ● Evidence of applied formulation/drug already approved by

Diary No. Date of R&I & Fees Dy no.1160, 2-5-2017 ; Rs.20,000/-

Decision: Approved.
281. Name and address of the M/s Genetics Pharmaceuticals (Pvt.) Ltd. 539-A, Sundar
manufacturer/Applicant Industrial Estate, Raiwind Lahore
Brand Name +Dosage Form + Strength Restrict 2mg Tablet

Repaglinide …2mg
Diary No. Date of R&I & Fees Dy No:1175, 02-05-2017.; Rs.20,000/-
Pharmacological Group Antidiabetic
Pack size & Demanded price 10‘s, 14‘s, 20‘s, 28‘s / As per SRO
Approval Status of product in Reference Prandin 2mg Tablet by Gemini Labs LLC approved by
Regulatory Authorities USFDA
Me – too Status Rapaglax Tablets 2mg by M/s Cirin Pharmaceuticals

Decision: Approved.
Brand Name +Dosage Form + Strength Restrict 0.5mg Tablet
Repaglinide …0.5mg
Diary No. Date of R&I & Fees Dy No.1168, 02-5-17; Rs.20,000/-
Approval Status of product in Reference Prandin 0.5mg Tablet by Gemini Labs LLC approved by
Me – too Status Rapaglax Tablets 0.5mg by M/s Cirin Pharmaceuticals

Decision: Approved.
Brand Name +Dosage Form + Strength Restrict 1mg Tablet

Repaglinide …1mg
Diary No. Date of R&I & Fees Dy No.1176; 02-05-2017, Rs.20,000/-
Approval Status of product in Reference Prandin 1mg Tablet by Gemini Labs LLC approved by
Me – too Status Rapaglax Tablets 1mg by M/s Cirin Pharmaceuticals

Decision: Approved.
Brand Name +Dosage Form + Strength Termigen 500mg Tablet

Levofloxacin (as hemihydrate)…500mg
Diary No. Date of R&I & Fees Dy No.1152, 2-5-2017; Rs.20,000/-
Pharmacological Group Fluoroquinolone Antibiotic
Approval Status of product in Reference Levaquin 500mg tablets of M/s Janssen Pharms approved by
Me – too Status Aerobay 500mg Tablet by M/s Bayer Pakistan

Decision: Approved.

Diary No. Date of R&I & Fees Dy No.1151; 02-5-2017: Rs.20,000/-
Me – too Status Aksolox 750mg Tablet by M/s Akson Pharmaceutical

Decision: Approved.

Me – too Status Aerobay 250mg Tablet by M/s Bayer Pakistan

Decision: Approved.

Diary No. Date of R&I & Fees Dy No.1164;02-5-2017; Rs.20,000/-
Pharmacological Group Partial Dopamine Agonist
Decision: Approved.
Brand Name +Dosage Form + Strength Candelong 32mg tablet

Candesartan Cilexetil …32 mg
Diary No. Date of R&I & Fees Dy no.1157; 02-05-2017, Rs.20,000/-
Pharmacological Group Angiotensin II receptor antagonist
Pack size & Demanded price 10‘s,14‘s,20‘s,28‘s / as per SRO
Approval Status of product in Reference Atacand 32mg Tablet by M/s Takeda Pharmaceutical,
Regulatory Authorities approved by USFDA
Me – too Status Advant 32mg Tablet by M/s Getz pharma

Decision: Approved.
Brand Name +Dosage Form + Strength Candelong 4mg tablet

Candesartan Cilexetil …4mg
Approval Status of product in Reference Atacand 4mg Tablet By M/s Takeda Pharmaceutical,
Regulatory Authorities Approved By USFDA
Me – too Status Advant 4mg Tablet by M/s Getz Pharma
Decision: Approved.
Brand Name +Dosage Form + Strength Candelong 8mg Tablet
Approval Status of product in Reference Atacand 8mg tablet by M/s Takeda Pharmaceutical, approved
Me – too Status Advant 8mg Tablet by M/s Getz pharma

Decision: Approved.
Brand Name +Dosage Form + Strength Candelong 16mg Tablet

Approval Status of product in Reference Atacand 16mg Tablet by M/s Takeda Pharmaceutical,
Regulatory Authorities Approved by USA FDA
Me – too Status Advant 16 mg Tablet by M/s Getz Pharma

Decision: Approved.
Brand Name +Dosage Form + Strength Candelong HCT 32/25 mg Tablet

Candesartan Cilexetil….32 mg
Hydrochlorothiazide ….25mg
Pharmacological Group Angiotensin II Receptor Antagonist / Diuretic
Approval Status of product in Reference Atacand Hct 32/25 mg Tablet By M/s Astrazeneca, Approved
Regulatory Authorities By USFDA
Me – too Status Advantec by M/s Getz Pharma
Decision: Approved.
Brand Name +Dosage Form + Strength Candelong HCT 16/12.5mg Tablet

Candesartan Cilexetil….16mg
Hydrochlorothiazide …..12.50mg
Diary No. Date of R&I & Fees Dy No1165.; 02-5-2017; Rs.20,000/-
Approval Status of product in Reference Atacand HCT 16/12.5mg Tablet by M/s Astrazeneca,
Me – too Status Advantec by M/s Getz Pharma

Decision: Approved.
Brand Name +Dosage Form + Strength Venadex ER 25mg Tablet
Composition Each Extended Release tablet contains:

Desvenlafaxine (as Succinate)…25mg
Diary No. Date of R&I & Fees Dy No.1167 ; 2-5-2017, Rs.20,000/-
Pharmacological Group Serotonin-norepinephrine reuptake inhibitor
Finish Product Specification Innovator
Approval Status of product in Reference Pristiq ER 25mg Tablet
Regulatory Authorities Wyeth Pharms INC, USFDA approved
Remarks of Evaluator ● Evidence of applied formulation/drug already approved by
● Provided reference Lafaxine ER tablet by Genix pharma can‘t
be confirm in this strength
● Firm wanted to apply on form 5D. additional 30,000/- has
been submitted but need stability data.
Brand Name +Dosage Form + Strength Candelong HCT 32/12.5mg Tablet
Candesartan Cilexetil….32mg
Hydrochlorothiazide……12.5mg
Approval Status of product in Reference Atacand HCT 32/12.5mg Tablet by M/s Astrazeneca,
Me – too Status Advantec Tablet by M/s Getz Pharma
Decision: Approved.
Brand Name +Dosage Form + Strength Venadex ER 50mg Tablet

Desvenlafaxine (as Succinate)…50mg
Pharmacological Group Serotonin-norepinephrine reuptake inhibitor
Finish Product Specification Innovator
Approval Status of product in Reference Pristiq ER 50mg Tablet
Regulatory Authorities Wyeth Pharms INC, USFDA approved
Me – too Status Lafaxine ER tablet by Genix pharma
Decision: Approved.
297. Name and address of the M/s. Magns Pharmaceuticals 7B, Value Addition City,
manufacturer/Applicant Khurrianwala Sahianwala Road, Faisalabad
Brand Name +Dosage Form + Strength Flomex 0.4 mg capsules
Composition Each Capsule Contains:

Tamsulosin HCl (as SR Pellets 0.2%)…0.4mg (USP Specs)
Diary No. Date of R&I & Fees DyN:1935, 8-5-2017, Rs.20,000/-
Pharmacological Group Alpha-adrenoreceptor antagonists
Pack size & Demanded price 20‘s / As per SRO
Approval Status of product in Reference Pinexel PR 400 micrograms Prolonged-Release Hard
Regulatory Authorities Capsules (MHRA approved)
Me – too Status M-Sol 0.4mg cap of M/s Regal Parma

GMP Status Last inspection conducted on 7- dec-2017 and report
concludes that firm is complying Good GMP as of today.
Remarks of Evaluator ● Source of pellets is Vision Pharma
Decision: Approved.
298. Name and address of manufacturer / M/s Medisure Laboratories, A-115, S.I.T.E, Super Highway,
Applicant Karachi
Brand Name +Dosage Form + Strength Asfree Sachet 4 mg
Composition Each sachet contains: Montelukast sodium eq. to

Montelukast……………4mg
Diary No. Date of R& I & fee Dy.No.1128, 2-05-2017, Rs.20,000/-
Pharmacological Group Leukotriene Receptor antagonist
Type of Form Form-5
Finished Product Specification Innovators
Approval status of product in Reference Singulair Sachet 4mg Granules of Merck , (USFDA)
Me-too status Montiget Sachet of Getz Pharma ( Reg # 044046)

GMP status Last inspection was conducted on 05-12-2017 for renewal /
grant of GMP Certificate and the report concludes good
compliance of GMP.
299. Name and address of manufacturer / M/s OBS Pakistan (Pvt) Ltd, C14 SITE Karachi
Applicant
Brand Name +Dosage Form + Strength Olra-H 20 mg/12.5 mg tablet
Composition Each film coated tablet contain

Olmesartan Medoxomil……………20 mg
Hydrochlorothiazide……………12.5 mg
Pharmacological Group Angiotensin II antagonists and diuretics
Type of Form Form-5
Pack size & Demanded Price 10‘s, 30‘s
As per SRO
Approval status of product in Reference Benicar Hct 12.5mg;20mg (USFDA)
Me-too status Co-Baritec of Barrett Hodgson
GMP status Last inspection was conducted on 11.04.2017 with no
observation
Remarks of evaluator
Applicant
Brand Name +Dosage Form + Strength Olra-H 40 mg/12.5 mg tablet

Hydrochlorothiazide……………12.5 mg
Type of Form Form-5
As per SRO
Approval status of product in Reference Benicar Hct 40mg;12.5 mg (USFDA)
Me-too status Co-Baritec of Barrett Hodgson
observation
Applicant
Brand Name +Dosage Form + Strength Olra-H 40 mg/25 mg tablet

Hydrochlorothiazide……………25 mg
Type of Form Form-5
As per SRO
Approval status of product in Reference Benicar Hct 25mg;40mg (USFDA)
Me-too status MALISARTAN -HT of ALIED MEDICAL
observation
302. Name and address of manufacturer / M/s Remington Pharmaceutical Industries Pvt. Ltd., 18 KM
Applicant Multan Road, Lahore
Brand Name +Dosage Form + Strength Idronate Tablets

Ibandronate sodium monohydrate
eq. to. Ibandronic acid…….150mg
Diary No. Date of R& I & fee Dyn: 1113, 2-05-2017, Rs.20,000/- (Duplicate)
Pharmacological Group Bisphosphonate
Type of Form Form-5
As per SRO
Approval status of product in Reference Boniva of Hoffmann la Roche (USFDA)
Me-too status Bongro 150mg Tablets of M/s Fassgen Pharmaceuticals
(073298)
GMP status GMP certificate issued against inspection conducted on 15
and 16th jan 2018 showing good compliance.
Remarks of evaluator No USP or BP monograph is available for applied formulation
Decision: Approved with innovators specifications. Reference will be sent to Budget & Accounts
Division for verification of challan and Board authorized its Chairman for the issuance of
registration letter.
303. Name and address of the M/s Remington Pharmaceutical Industries Pvt. Ltd., 18 KM
manufacturer/Applicant Multan Road, Lahore
Brand Name +Dosage Form + Strength Dozypress Eye Drops

Dorzolamide HCl eq to Dorzolamide……20 mg
Diary No. Date of R&I & Fees DyN:1110, 2-5-2017, Rs.20,000/- (Duplicate of 388545/-)
Pharmacological Group Carbonic anhydrase inhibitors
Pack size & Demanded price 5 ml
As per SRO
Approval Status of product in Reference TRUSOPT 2% of Merck (USFDA)
Me – too Status Isdorz (20 mg eye drops) ISIS Pharmaceuticals
GMP Status GMP certificate issued against inspection conducted on 15
Decision: Approved. Reference will be sent to Budget & Accounts Division for verification of challan
and Board authorized its Chairman for the issuance of registration letter.
Brand Name +Dosage Form + Strength Orthocox 60 mg tablet

Etoricoxib……60 mg
Finish Product Specification As per innovators
Pack size & Demanded price 10‘s
As per SRO
Approval Status of product in Reference ARCOXIA 60mg Film-Coated Tablets (MHRA approved)
Me – too Status Etoricox of KAIZEN PHARMACEUTICALS PVT LTD
Remarks of Evaluator No USP and BP monograph was found
Decision: Approved with innovators specifications. Approved. Reference will be sent to Budget &
Accounts Division for verification of challan and Board authorized its Chairman for the issuance of
Brand Name +Dosage Form + Strength Astro 2 g Sachet
Composition Each 5 gm Sachet contains:

Strontium Ranelate……2 g
Pharmacological Group Bone structure and mineralization modifier
Pack size & Demanded price 7‘s / As per SRO
Approval Status of product in Reference Strontium ranelate Aristo 2 g granules for oral suspension
Regulatory Authorities (MHRA approved)
Me – too Status Orelate oF Wns Field Pharmaceuticals
and 16th jan 2018 showing good compliance
Remarks of Evaluator No USP and BP monograph was found
Decision: Approved with innovators specifications. Reference will be sent to Budget & Accounts
306. Name and address of manufacturer / M/s Scilife Pharma (Pvt) Limited, Plot # FD-57/58-A2,
Applicant Korangi Creek Industrial Park, Karachi
Brand Name +Dosage Form + Strength Foxatin 20 mg capsule

Fluoxetine as hydrochloride…20mg
Pharmacological Group Antidepressant ( SSRI)
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 7, 10, 14 20‘s
As per SRO
Approval status of product in Reference Prozac 20mg capsule by M/S Eli Lilly And Co, USFDA
Regulatory Authorities. approved
Me-too status Depex 20mg capsule by M/s Merck (Reg#020245)

compliance of GMP.
Decision: Approved.
Brand Name +Dosage Form + Strength Geoxit 40mg Capsule

Fluoxetine (as hydrochloride)…40mg
Diary No. Date of R&I & Fees Dy No.1172;02-5-17, Rs.20,000/-
Approval Status of product in Reference Prozac 40mg capsule by M/s Eli Lilly And Co, approved by
Brand Name +Dosage Form + Strength Geoxit 20mg Capsule

Fluoxetine (as hydrochloride)…20mg
Approval Status of product in Reference Prozac 20mg capsule by M/s Eli Lilly And Co, approved by
Me – too Status Mesart-H by M/s Aventis Pharmaceuticals

Decision: Approved.
Brand Name +Dosage Form + Strength Pantogen DR 20mg Tablet
Composition Each Delayed Release tablet contains:

Pantoprazole (as sodium sesquihydrate)…20mg
Diary No. Date of R&I & Fees Dy No.1153; 02,5,17, Rs.20,000/-
Pharmacological Group Proton Pump Inhibitor (PPI)
Approval Status of product in Reference Protonix 20mg DR Tablet by M/s Wyeth Pharms INC,
Regulatory Authorities approved by USFDA
Me – too Status Pantocare DR 20mg Tablet by M/s Aims Pharmaceuticals

Decision: Approved.
Brand Name +Dosage Form + Strength Safenac 100mg Tablet
Aceclofenac…100mg
Approval Status of product in Reference Preservex 100mg Tablet by M/s Almirall S.A, (MHRA)
Me – too Status Zinase 100mg Tablets by M/s Opal Laboratories
Remarks of Evaluator No USP or BP monograph was found.
Brand Name +Dosage Form + Strength Ranolaz ER 500mg Tablet

Ranolazine…500mg
Pharmacological Group Anti–ischemic and anti- angina
Finish Product Specification As per Innovators
Approval Status of product in Reference Ranexa 500mg ER Tablet by M/s Gilead, approved by
Me – too Status Razin 500mg ER tablet by M/s Getz Pharma

Remarks of Evaluator No USP or BP monograph is available for applied
Formulation
Brand Name +Dosage Form + Strength Ranolaz ER 1000mg Tablet

Ranolazine…1000mg
Diary No. Date of R&I & Fees Dy No.1146 ; 2-5-17, Rs.20,000/-
Pharmacological Group Anti–ischemic and anti- angina
Finish Product Specification Innovators
Approval Status of product in Reference Ranexa 1000mg ER Tablet by M/s Gilead, approved by
Me – too Status Rangizin XR 1000mg by M/s Macter Intr. Karachi
(Reg#079548)
Remarks of Evaluator No USP or BP monograph is available for applied
Formulation
313. Name and address of manufacturer / M/s Mafins Pharma A-5 S.I.T.E Super Highway, Karachi
Applicant
Brand Name +Dosage Form + Strength Lansofin 30mg Capsule
Composition Each Capsules Contains:

Enteric coated pellets of Lansoprazole 8.5%w/w equivalent to
Lansoprazole… 30mg
Diary No. Date of R& I & fee Dy.No.883, 9-01-2017, Rs.20,000/- (80,000/-2-3-2018)
Type of Form Form-5
Approval status of product in Reference Lansoprazole Capsules 30mg by Mylan Pharma approved by
Regulatory Authorities. USFDA.
Me-too status D – Burn by Nexus Pharma

of good cGMP compliance.
Remarks of Evaluator Source of pellets Kola pharma India.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Dofin-SR 100mg Capsule

Diclofenac sodium enteric coated pellets (33%)
equivalent to Diclofenac sodium…………….100mg
Diary No. Date of R& I & fee Dy.No.867, 9-01-2017, Rs.20,000/- & 80,000/-(2-3-18)
Type of Form Form-5
Finished Product Specification Manufacturer
Approval status of product in Reference Rhumalgan XL 100 mg modified-release capsules (MHRA)
Me-too status Phlogin SR (100 mg Capsule) Brookes Pharma, Karachi

Remarks of Evaluator Source of Pellets Kola Pharma India
Applicant
Brand Name +Dosage Form + Strength Mafodin 60mg Tablet

Fexofenadine HCl….60mg
Pharmacological Group H1 Receptor Antagonist
Type of Form Form-5
Approval status of product in Reference Allegra tablet USFDA Approved
Me-too status Afex of Shaheen Agencies
Applicant
Brand Name +Dosage Form + Strength Clomafin 100 mg Tablet

Clotrimazole……….100 mg
Pharmacological Group Anti-fungal
Type of Form Form-5
Finished Product Specification BP
Approval status of product in Reference Mycelex-7 Vaginal Tablet (USFDA)
Me-too status Davizol-V Of Davis
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Citrofin 10mg Tablet
Composition Each film coated tablet contains
Cetirizine (as hydrochloride)…….10 mg
Pharmacological Group Antihistamine
Type of Form Form-5
Approval status of product in Reference Zyrtec Allergy Tablet of J & J consumer (USFDA
Me-too status Sedil tablet of Sami Pharmaceuticals

Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Miforec 10mg Tablet
Amlodipine Besilate equivalent to Amlodipine…..10mg
Pharmacological Group (Calcium channel blocker)
Type of Form Form-5
Approval status of product in Reference Norvasc by Pfizer
Regulatory Authorities. (USFDA Approved)
Me-too status Amlobest of Pearl Pharmaceuticals

Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Mybrofen Cream

Ibuprofen…….100mg
Pharmacological Group Anti-inflammatory
Type of Form Form-5
Me-too status Artijesic of Medisearch Pharmacal(Pvt) Ltd

Remarks of Evaluator Evidence of formulation on reference regulatory authority
can‘t be verified from MHRA provided reference Ibuprofen
10% w/w is in gel
authorities/ agencies as adopted by by the Registration Board in its 275th meeting.
320. Name and address of the M/s. Himont Pharma, 17 Km, Ferozepur Road Lahore
manufacturer/Applicant
Brand Name +Dosage Form + Strength GlitaFame Plus Tablet 15/500 mg

Pioglitazone (HCl)…15 mg
Metformin HCl…500 mg
Diary No. Date of R&I & Fees Duplicate (R&I 8-5-17), 17-2-12, Rs.8,000/- (17-2-12),
35,000/- (10-2-2015) (Duplicate)
Pharmacological Group Thiazolidinedione/ Biguanide
Pack size & Demanded price 2x7‘s
Rs 98/-
Approval Status of product in Reference Actoplus met of Takeda (USFDA)
Me – too Status PIORYL-M of Bosch pharma
GMP Status Last inspection conducted on 14-April-2017 & 11 May 2017
and report concludes the renewal of section except capsule
(general) and cephalosporin sections
Brand Name +Dosage Form + Strength Mirtasat tablet 15 mg
Mirtazapine……15 mg
Diary No. Date of R&I & Fees Duplicate (R&I: 1858), 17-2-12, Rs.12,000/- (10-2-15),
8,000/- (12-1-2012) (Duplicate)
Rs 392/-
Approval Status of product in Reference Mirtazapine 15 mg Tablets by M/s Teva (USFDA)
Me – too Status Notense 15 mg Tablets by M/s Qintar Pharma
Brand Name +Dosage Form + Strength Mirtasat tablet 30 mg
Mirtazapine……30 mg
Diary No. Date of R&I & Fees Duplicate (R&I: 1854), -2-12, Rs.12,000/- (23-1-15), 8,000/-
(12-1-2012) (Duplicate)
Rs 739/-
Approval Status of product in Reference Mirtazapine 15 mg Tablets by M/s Teva (USFDA)
Me – too Status Notense 15 mg Tablets by M/s Qintar Pharma
323. Name and address of manufacturer / M/s. Friends Pharma, 31 km, Ferozepur road Lahore
Applicant
Brand Name +Dosage Form + Strength Viocef injection 250 mg
Composition Each glass vial contains:

Cephradine HCl……… 250 mg
Type of Form Form-5
Approval status of product in Reference USFDA approved but discontinued
Me-too status Cefrinex by Bosch
GMP status Last GMP Inspection dated 6 oct 2016 with conclusive
remarks of cGMP compliance.
Remarks of Evaluator ● Latest GMP inspection report (which should have been
conducted within the period of last one year).
● Evidence of approval of applied formulation in reference
regulatory authorities could not be confirmed
authorities/agencies which were declared/approved by the Registration Board in its 275th meeting
and updated status of GMP of the firm form QA & LT division as inspection report submitted by
firm is not with in one year.
324. Name and address of manufacturer / M/s High-Q Pharmaceuticals, Plot No.224, Sector 23 Korangi
Applicant Industrial Area, Karachi contract by M/s English
Pharmaceutical Industries, Link Kattar Bund Road, Thokar
Niaz Baig, Multan Road, Lahore
Brand Name +Dosage Form + Strength Eskem 40 mg injection

Esomeprazole (as sodium)……….40mg
Diary No. Date of R& I & fee Duplicate; Rs. 50,000/- (12-feb-2013) (Duplicate)
Type of Form Form-5
Me-too status Nexum IV 40mg Injection by M/s Getz Pharma, Karachi,
(Reg#050651)
GMP status Certificate of last, GMP Inspection dated 16-1-18 with cGMP
compliance.
Remarks of Evaluator ● The firm previously want to contract with M/S Nabiqasim in
2013 but before receiving registration they change it to M/S
English Pharmaceuticals.
● The Firm has 7 sections and they are currently manufacturing
4 products on contract manufacturing basis.
Decision: Approved with change of brand name. Reference will be sent to Budget & Accounts
325. Name and address of manufacturer / M/s. Hamaz Pharmaceuticals (Pvt.) Ltd; 13 km, Bosan road,
Applicant Lutfabad, Multan
Brand Name +Dosage Form + Strength Prevacid 200 mg tablet

Cimetidine……….200 mg
Diary No. Date of R& I & fee Dy#2135; 4-4-2012, Rs. 8,000/- (14-jun-2010), 12000 (28-1-
2015)
Pharmacological Group H2 blocker
Type of Form Form-5
Pack size & Demanded Price 88 per 20 tablets
Approval status of product in Reference Cimetidine 200mg of Teva (USFDA)
Me-too status Acedil of Irza Pharma
GMP status Certificate of last, GMP Inspection dated 01.08.2017 with
cGMP compliance.
Decision: Approved.
Brand Name +Dosage Form + Strength Claritab tablet 250 mg
Clarithromycin……….250 mg
2015)
Type of Form Form-5
Pack size & Demanded Price 358 per 10 tablets
Approval status of product in Reference Klaricid of (MHRA approved)
Me-too status Claramed of Novartis Pharma
cGMP compliance.
Decision: Approved.
Brand Name +Dosage Form + Strength Rockcef suspension 250 mg
Composition Each 5 ml after reconstitution contains: Cephradine…250mg
2015)
Pharmacological Group 1st Generation Cephalosporin
Type of Form Form-5
Pack size & Demanded Price 128/ 60 ml
60 and 90 ml
Approval status of product in Reference Cefradine 250mg/5ml dry powder for syrup by M/s Strides
Regulatory Authorities Pharma UK Ltd (MHRA Approved)
Me-too status Licef Dry Powder suspension 250mg/5ml by M/s Wisdom
cGMP compliance.
Decision: Approved.
Brand Name +Dosage Form + Strength Simecol suspension 120 ml
Composition Each 5 ml contains:-

Dicyclomine HCl….5 mg
Simethicone ……50mg
Diary No. Date of R& I & fee Duplicate , Rs. 8,000/- (7-7-2010), 12000 (20-1-2015)
Pharmacological Group Antispasmodic/Anticholinergic
Type of Form Form-5
Pack size & Demanded Price 120 ml suspension
Approval status of product in Reference Could not be confirmed.
Me-too status Infacol of spencer pharma
cGMP compliance.
Remarks of Evaluator Evidence of approval of applied formulation in reference
country could not be confirmed.
authorities/agencies as adopted by the Registration Board in its 275th meeting.
Brand Name +Dosage Form + Strength Artex-K 75
Diclofenac potassium…75mg
Diary No. Date of R& I & fee Duplicate , Rs. 8,000/- (7-7-2010), 12000 (20-1-2015)
Pharmacological Group Antispasmodic/Anticholinergic
Type of Form Form-5
As per SRO
Me-too status Biodic-P of /biorex
GMP status Certificate of last, GMP Inspection dated 01.08.2017.with
cGMP compliance.
Remarks of Evaluator ● Evidence of approval of applied formulation in reference
regulatory authorities/agencies which were declared/approved
by the Registration Board in its 275th meeting.
● Methylene chloride is discontinued/banned excipients. For this
reason, revise the formulation is needed.

authorities/agencies s adopted by the Registration Board in its 275th meeting and for clarification
regarding use of banned excipient (Methylene chloride).
330. Name and address of manufacturer / M/s Wnsfeild Pharmaceuticals. Plot no. 122, Phase V, Block
Applicant A, Industrial Estate Hattar.
Brand Name +Dosage Form + Strength Zovipet 600 mg infusion
Composition Each 300 ml contain

Linezolid………….600
Diary No. Date of R& I & fee Dyn# 1112, 11-1-2017, Rs, 20,000/- (new Fee: 20,000/- 2-2-
2018)
Pharmacological Group Anti-Bacterial
Type of Form Form 5
Finished product Specifications Manufacturer specs
Approval status of product in Reference LINEZOLID of Teva 600 mg/300 ml (FDA Approved)
Me-too status NEZOCIN of BROOKES PHARMACEUTICAL
LABORATORIES (PAK.) LTD.
GMP status DML Renewal Inspection Date: 18th January, 2018
Remarks of Evaluator Firm originally applied for the formulation,
Linzowin 100 mg infusion IV
Each 100 ml infusion contains:
Linezolid…………..2 mg/ml
● Firm provided full 20,000 fee dated 2-2-2018.
decided as under;
innovator of the product i.e M/s Pfizer which has clearly mention the storage precautions in its
Product Information Leaflet (PIL). They will also make sure that the solution is kept correctly
in its box and foil wrapping in order to protect from light.”
331. Name and address of manufacturer / M/s Wnsfeild Pharmaceuticals. Plot no. 122, Phase V, Block
Applicant A, Industrial Estate Hattar.
Brand Name +Dosage Form + Strength Olabex 3/25 mg cap
Olanzapine……………3 mg
Fluoxetine as HCL ……………25 mg
Diary No. Date of R& I & fee Dyn# 1113, 11-1-2017, Rs, 20,000/- (new fee 20,000/-
2/2/2018)
Pharmacological Group Antipsychotics/SSRI
Type of Form Form 5
Approval status of product in Reference SYMBYAX CAPSULE by Lily Pharma, USA.
Me-too status Co-Depricap Capsule by M/s Nabiqasim
GMP status DML Renewal Inspection Date: 18th January, 2018
Remarks of Evaluator Firm originally applied for the formulation,
Oleza 6/25 mg capsules
Each capsule contains:
olanzapine…6 mg
Fluoxetine as Hcl…25 mg
Firm provided full 20,000 fee dated 2-2-2018.
Decision: Approved.
Evaluator-PEC-VI
332. Name and address of manufacturer / M/s Dyson Research laboratories, Lahore
Applicant
Brand Name +Dosage Form + Strength Tamflow capsules 0.4mg

Tamsulosin HCl (Sr pellets)……0.4mg
Pharmacological Group Alpha-adrenoceptor antagonist
Type of Form Form-5
Me-too status Duodart Of GSK
GMP status Last inspection conducted on 1-8-2017 with satisfactory GMP
compliance.‖
Remarks of the Evaluator. Pellets are obtained from Vision Pharma.
Decision: Approved.
333. Name and address of manufacturer / M/s Nawan Laboratories, Karachi
Applicant
Brand Name +Dosage Form + Strength Nitazon 500mg tablet

Nitazoxanide…….500mg
Pharmacological Group Anti-diarrhoeal
Type of Form Form-5
Finished product Specification Manufacturer‘s Specification
Pack size & Demanded Price 20‘s, As per DPC
Me-too status Nizonide 500mg Reg # 081101
GMP status Routine GMP inspection conducted on 26-09-2017, the firm
found to be operating at a satisfactory level of GMP
compliance.
334. Name and address of manufacturer / M/s Genix Pharma, Karachi
Applicant
Brand Name +Dosage Form + Strength Pire-1 Tablets

Ethambutol HCl……400mg
Pharmacological Group Antimycobacterial
Type of Form Form-5
Approval status of product in Reference USFDA
Me-too status Etham by Pacific Reg No. 057252
compliance of GMP.
Decision: Deferred for consideration according to queue of the application.
335. Name and address of manufacturer / M/s Focus&Rulz Pharmaceuticals, Islamabad
Applicant
Brand Name +Dosage Form + Strength Nicoran tablet 20mg

Nicorandil……20mg
Pharmacological Group Vasodilator
Type of Form Form-5
Pack size & Demanded Price 10‘s, 20‘s, 30‘s, 40‘s, 50‘s, 60, As per SRO
Approval status of product in Reference Ikorel 20mg Tablet (Sanofi-Aventis)
Regulatory Authorities. MHRA- UK approved
Me-too status Nicoget (Getz) Reg. No. 045369
GMP status Last inspection report 4-5-2017 The overall conclusion is
prospective with a view that from previous observations
improvements have been made and the firm is following the
GMP guidelines and is working on adopting new means of
improvements in accordance to GMP Guidelines.
Applicant
Brand Name +Dosage Form + Strength Claro 125mg/5ml Suspension
Composition Each 5ml reconstituted suspension contains:
Cefaclor monohydrate eq to Cefaclor…….125mg
Type of Form Form-5
Pack size & Demanded Price 30ml, 60ml, 90ml, As per SRO
Approval status of product in Reference Cefaclor 125mg/5ml Suspension by M/s Strides Pharma UK
Regulatory Authorities. Ltd (MHRA approved)
Me-too status Sac-Lor 125mg/5ml Dry Suspension by M/s Semos Pharma
(Reg#081617)
Remarks of the Evaluator. Firm has dry powder cephalosporin and capsule cephalosporin
section.
Applicant
Brand Name +Dosage Form + Strength Claro 500mg capsules
Type of Form Form-5
Pack size & Demanded Price 12‘s, 14‘s, 10‘s, 20‘s, 28‘s, As per SRO
Approval status of product in Reference Cefaclor Capsules 500mg by M/s Strides Pharma UK Ltd
Me-too status Faceclor 500mg Capsule by M/s City Karachi (Reg#070601)
section.
Applicant
Brand Name +Dosage Form + Strength Nicoran tablet 10mg

Nicorandil……10mg
Pharmacological Group Vasodilator
Type of Form Form-5
Pack size & Demanded Price 10‘s, 20‘s, 30‘s, 40‘s, 50‘s, 60, As per SRO
Approval status of product in Reference Ikorel 10mg Tablet (Sanofi-Aventis)
Regulatory Authorities. MHRA- UK approved
Me-too status Nicoget (Getz) Reg. No. 045368
Applicant
Brand Name +Dosage Form + Strength Claro 250mg/5ml Suspension
Composition Each 5ml reconstituted suspension contains:

Type of Form Form-5
Pack size & Demanded Price 30ml, 60ml, 90ml, As per SRO
(Reg#081618)
section.
Applicant
Brand Name +Dosage Form + Strength Claro 250mg capsules

Type of Form Form-5
Pack size & Demanded Price 12‘s, 14‘s, 10‘s, 20‘s, 28‘s, As per SRO
Approval status of product in Reference Cefaclor 250mg Capsules by M/s Ranbaxy (UK) Limited
Me-too status Faceclor 250mg Capsule by M/s City Karachi (Reg#070600)
section.
Applicant
Brand Name +Dosage Form + Strength Gvia-M 50mg/850mg tablets

Sitagliptin Phosphate Monohydrate eq to Sitagliptin…..50mg
Metformin HCl…..850mg
Type of Form Form-5
Pack size & Demanded Price 14‘s, 28‘s, As per SRO
Approval status of product in Reference Janumet tablets of (TGA approved)
Me-too status S-Gliptin Plus Tablets of M/s Barrett Hodgson
compliance of GMP.
Applicant
Brand Name +Dosage Form + Strength Pire-1 Tablets
Ethambutol HCl……100mg
Pharmacological Group Antimycobacterial
Type of Form Form-5
Me-too status Could not be confirmed
compliance of GMP.
Remarks of the Evaluator. Me-too status could not be confirmed.
me-too status) along with registration number, brand name and name of firm.
343. Name and address of manufacturer / M/S Linta Pharmaceuticals, Islamabad
Applicant
Brand Name +Dosage Form + Strength Amtin 5mg/160mg tablets

Amlodipine(as amlodipine besylate)……5mg
Valsartan……..160mg
Type of Form Form-5
Approval status of product in Reference Exforge by Novartis Pharma GmbH, (USFDA)
Me-too status Exforge by Novartis Pharma. Karachi
GMP status Last Inspection report 8-6-2017 firm may be issued GMP
certificate as the firm is found to be complying GMP
standards as of today.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Fabix 40mg tablets

Febuxostat………40mg
Pharmacological Group Xanthine Oxidase inhibitor
Type of Form Form-5
Approval status of product in Reference ULORIC by Takeda Pharmaceuticals
(USFDA Approved)
Me-too status Zurig by Getz
GMP status Last Inspection report 8-6-2017 firm may beissued GMP
certificate as the firm is found o be complying GMP standards
as of today.
345. Name and address of manufacturer / M/s Linta Pharmaceuticals, Islamabad
Applicant
Brand Name +Dosage Form + Strength Vanix 800mg tablets

Sevelamer HCl………800mg
Pharmacological Group Phosphate binding drug used to treat hyperphosphatemia
Type of Form Form-5
Approval status of product in Reference Renagel tablet of (FDA approved)
Me-too status Renamer tablet M/s Ciba Pharmaceuticals
as of today.
Applicant
Brand Name +Dosage Form + Strength Prix 10mg tablets

Escitalopram(as oxalate)………10mg
Pharmacological Group Selective Serotonin reuptake inhibitor
Type of Form Form-5
Approval status of product in Reference Escitalopram 10 mg Of ( MHRA Approved)
Me-too status Gentle 10mg Tablet Of M/S Wilson‘s Pharmaceuticals,
as of today.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Amtin10mg/160mg tablets

Amlodipine (as amlodipine besylate)……10mg
Type of Form Form-5
Approval status of product in Reference Exforge by Novartis Pharma GmbH, (USFDA)
Me-too status Exforge by Novartis Pharma. Karachi (R. No. 047571)
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength B-Ton 8mg tablets

Betahistine Dihydrochloride…….8mg
Type of Form Form-5
Me-too status Betalin Tablet 8mg Reg # 081874
as of today.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Fabix 80mg tablets

Febuxostat………80mg
Pharmacological Group Xanthine Oxidase inhibitor
Type of Form Form-5
Approval status of product in Reference ULORIC by Takeda Pharmaceuticals
Me-too status Zurig by Getz
as of today.
Applicant
Brand Name +Dosage Form + Strength Amtin5mg/80mg tablets
Amlodipine (as amlodipine besylate)……5mg
Type of Form Form-5
Approval status of product in Reference Exforge 5/80mg tablet of M/s Novartis Pharma (UK) Limited
Regulatory Authorities. (emc-MHRA Approved)
Me-too status Exforge 5/80mg tablet of M/s Novartis Pharma (Pak) Limited
as of today.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Vanix 400mg tablets

Sevelamer HCl………400mg
Pharmacological Group Phosphate binding drug used to treat hyperphosphatemia
Type of Form Form-5
Approval status of product in Reference Renagel 400mg Tablet by M/s Genzyme Corporation,
Me-too status Renavel 400mg Tablet by M/s AllianzeMed
as of today.
352. Approved with innovator‘s specification. M/S Linta Pharmaceuticals, Islamabad
Name and address of manufacturer /
Applicant
Brand Name +Dosage Form + Strength B-Ton 16mg tablets

Betahistine Dihydrochloride…….16mg
Type of Form Form-5
Me-too status D-Vert 16mg tablets of M/s Remington Pharma
GMP status Last Inspection report 8-6-2017 firm may be issued GMP
353. Name and address of manufacturer / M/s Indus Pharma, Karachi
Applicant
Brand Name +Dosage Form + Strength Miralax sachet
Macrogol 3350……8.5gm
Pharmacological Group Osmotically acting Laxative
Type of Form Form-5
Finished product Specification Manufaturer‘s Specification
GMP status Last inspection report 16-8-2017 firm was considered to be
operating at an acceptable level of compliance with GMP
Remarks of the Evaluator. Fee challan photocopy attached.
Me-too status could not be confirmed
354. Name and address of manufacturer / M/s Indus Pharma, Karachi
Applicant
Brand Name +Dosage Form + Strength Miralax Plus sachet
Macrogol 3350……13.125gm
Sodium chloride…..350.7mg
Sodium Hydrogen carbonate……178.5mg
Potasium Chloride……46.6mg
Pharmacological Group Osmotically acting Laxative
Type of Form Form-5
Finished product Specification Manufaturer‘s Specification
Pack size & Demanded Price 10‘s, Rs.255/pack
Approval status of product in Reference Movicol 13.8g sachet, powder for oral solution by M/s
Regulatory Authorities. Norgine Limited (MHRA Approved)
Me-too status Marfinal Sachet 13.8g by M/s Martin Dow (Reg#080647)
Remarks of the Evaluator. Fee challan photocopy attached
Decision: Approved with innovator’s specification. Reference will be sent to Budget & Accounts
355. Name and address of manufacturer / M/s Helix Pharma, Karachi
Applicant
Brand Name +Dosage Form + Strength Cymanta 30mg capsules

Duloxetine as HCl(enteric coated pellets)…..30mg
Diary No. Date of R& I & fee Dy. No.32; 1-2-2017; Rs.20,000/- (1-2-2017), Rs.80,000- (15-
11-2017)
Pharmacological Group SNRI
Type of Form Form-5
Approval status of product in Reference Cymbalta Health Canada Approved
Me-too status Loxe 30mg capsule of Genix Pharma
report concludes that firm was at satisfactory level of GMP
compliance
Remarks of the Evaluator. Pellets are imported from Pell Tech Health care, India.
GMP certificate of Pell tech is valid up to 28 Sep 2018.
Rs.20,000 fee challan photocopy is attached
356. Name and address of manufacturer / M/s Albro Pharmaceuticals, Lahore
Applicant
Brand Name +Dosage Form + Strength Pregabro capsule 75mg
Pregabalin…..75mg
Diary No. Date of R& I & fee Dy. No.32; 3-1-2011; Rs.8,000/- (3-1-2011), Rs.12,000, 19-2-
2015
Type of Form Form-5
Me-too status Gabica capsule by M/s Getz Pharma
GMP status Firm has submitted last GMP inspection report dated 26-10-
2017, 6-12-2017, the panel decided to recommend the renewal
of DML.
357. Name and address of manufacturer / M/s Medisave Pharmaceuticals, Lahore
Applicant
Brand Name +Dosage Form + Strength Zolnic Infusion 5mg/100ml
Zoledronic acid monohydrate eq to zoledronic acid …..5mg
Pharmacological Group Bisphosphonate
Type of Form Form-5
Pack size & Demanded Price 100ml‘s, As per SRO
Me-too status Zoldric by Searle
GMP status The firm was granted GMP certificate based upon inspection
conducted on 11-12-2017 & 10-01-2018 and recommended
for renewal of DML.
Evaluator PEC-III
S. Name and Brand Name Type of Remarks on the Remarks of Decision of 281st
No. address of (Proprietary Form formulation (if Evaluator (if meeting of
manufactur name + Dosage Initial date, any) including any) Registration
er / Form + Strength) diary International Board
Applicant Composition Fee status in
Pharmacological including stringent drug
Group differential regulatory
Finished product fee agencies /
Specification authorities
Demanded Me-too status
Price /
Pack size
358. PharmEvo Rasgil 0.5mg Tablet Form-5-D Azilect Tablet by ● Firm Approved with
(Pvt) Ltd., Plot Each tablet contains: 12-10-2010 Teva had initially innovator’s
# A-29, North Rasogiline (as (DUPLICATE (USFDA applied on specification.
Western mesylate)…….0.5m DOSSIER) Approved) Form 5-D, Reference will
Industrial Zone g PKR 15000/- but later be sent to
Port Qasim (Anti-Parkinson) (3-10-2010) Alzilo tablets by provided Budget &
Karachi (DUPLICATE Searle Form 5 since Accounts
) the Division for
+ Last inspection formulation verification of
PKR 5000/- dated 23-02-2018 is already challan and
19-11-2014 confirms that the registered. Board
10‘s: Rs. 200/- firm is operating at authorized its
20‘s: Rs. 400/- an acceptable level Chairman for
30‘s: Rs. 600/- of GMP compliance the issuance of
registration
letter.
359. PharmEvo Rasgil Tablets 1mg Form-5-D Azilect Tablet by ● Firm Approved with
(Pvt) Ltd., Plot Each tablet contains: 12-10-2010 Teva had initially innovator’s
# A-29, North Rasogiline (as (DUPLICATE (USFDA applied on specification.
Western mesylate)…….1mg DOSSIER) Approved) Form 5-D, Reference will
Industrial Zone PKR 15000/- but later be sent to
Port Qasim (Anti Parkinson) (3-10-2010) Alzilo tablets by provided Budget &
Karachi (Duplicate) Searle Form 5 since Accounts
+ the Division for
PKR 5000/- Last inspection formulation verification of
19-11-2014 dated 23-02-2018 is already challan and
10‘s: Rs. 220/- confirms that the registered. Board
20‘s: Rs. 450/- firm is operating at authorized its
30‘s: Rs. 675/- an acceptable level Chairman for
of GMP compliance the issuance of
registration
letter.
360. Reko Sitavie Tablet Form 5 Janumet Approved with
Pharmacal Each film coated 5-9-2012 50mg/500mg innovator’s
(Pvt) Ltd. 13- tablet contains:- (DUPLICATE Tablets by Merck specification.
KM, Multan Sitagliptin (as DOSSIER) (USFDA approved) Reference will
Road Lahore phosphate PKR 8,000/- be sent to
monohydrate)…..5 (Duplicate) Duvel Plus Budget &
0mg (30-8-2012) 50mg/500mg Tablet Accounts
Metformin + by Martin Dow Division for
hydrochloride….5 PKR 12,000/- verification of
00mg (6-3-2014) Last inspection challan and
14‘s: Rs. 238/- report dated 2-05- Board
2017: Panel authorized its
recommended Chairman for
renewal of DML the issuance of
registration
letter.
361. UDL Cefa Bact Form 5 (PMDA Japan ● Firm Approved.
Pharmaceutic Injection 1g Dy No. 1287 Approved) has dry Reference will
als, Plot No. Each vial contains: 23-9-2016 powder be sent to
E-44, & E-45, Cefoperazone (as PKR 20,000/- Cebac Injection (Cephalospor Budget &
North sodium)…500mg (Duplicate) 1gm by M/s Bosch in) injection Accounts
Western Sulbactam (as 1‘s: As per section. Division for
Industrial sodium)…500mg Innovator Last inspection● Firm verification of
Zone, Port cephalosporin + dated 01-11-2017 has submitted challan and
Qasim Beta-lactamase recommended attested copiy Board
authority, Inhibitor resumption of of fee challan authorized its
Karachi production and from Allied Chairman for
JP Specs reported GMP Bank Ltd. the issuance of
●
compliance of the Bran registration
firm d name letter.
resembles
with already
approved
name i.e.
Cefobact
362. UDL Cefa Bact Form 5 (Approved by 3 ● Firm Approved.
Pharmaceutic Injection 2g Dy No. 1288 European countries) has dry Reference will
als, Plot No. Each vial contains: 23-9-2016 powder be sent to
E-44, & E-45, Cefoperazone (as PKR 20,000/- Cebac Injection (Cephalospor Budget &
North sodium)……1000 (Duplicate) 1gm by M/s Bosch in) injection Accounts
Western mg 1‘s: As per section. Division for
Industrial Sulbactam (as Innovator Last inspection ● Firm verification of
Zone, Port sodium)……1000 dated 01-11-2017 has submitted challan and
Qasim mg recommended attested copiy Board
authority, cephalosporin + resumption of of fee challan authorized its
Karachi Beta-lactamase production and from Allied Chairman for
Inhibitor reported GMP Bank Ltd. the issuance of
compliance of the ● Bran registration
JP Specs firm d name letter.
resembles
with already
approved
name i.e.
Cefobact
363. UDL Gabinal Capsule Form 5 Lyrica Capsule by ● Firm Approved with
Pharmaceutic 100mg Dy No. 1286 PF Prism CV has Capsule innovator’s
als, Plot No. Each capsule 23-9-2016 (USFDA Approved) (General) specification.
E-44, & E-45, contains: PKR 20,000/- section. Reference will
North Pregabalin..100mg (Duplicate) Lyrica capsule by ● Firm be sent to
Western 2 x 7‘s: As per Pfizer has submitted Budget &
Industrial (Antiepileptics) Innovator attested copiy Accounts
Zone, Port Last inspection of fee challan Division for
Qasim dated 01-11-2017 from Allied verification of
authority, recommended Bank Ltd. challan and
Karachi resumption of Board
production and authorized its
reported GMP Chairman for
compliance of the the issuance of
firm registration
letter.
364. Novartis Xorol tablet 1mg Form 5 Detrusitol by Pfizer ● T Registration
Pharma Each film coated 29-09-2014 (MHRA Approved) he firm has Board rejected
(Pakistan) Ltd.,tablet contains: Dy. No. 123 applied for the application
Petaro Road Tolterodine Rs. 8000/- Akodine 1mg by these since the
Jamshoro tartrate…….1mg Rs.12,000/- Akhai Pharma products at applicant firm
Antimuscrinic 26-09-2014 its Jamshoro does not hold a
14‘s Plant, now valid Drug
Rs. 280/pack this plant has Manufacturing
been License for
purchased by Jamshoro site.
GSK
365. Novartis Xorol tablet 2mg Form 5 Detrusitol by Pfizer ● T Registration

Pharma Each film coated 29-09-2014 (MHRA Approved) he firm has Board rejected
(Pakistan) Ltd.,tablet contains: Dy. No. 124 applied for the application
Petaro Road Tolterodine Rs. 8000/- Akodine 1mg by these since the
Jamshoro tartrate…….2mg Rs.12,000/- Akhai Pharma products at applicant firm
Antimuscrinic 26-09-2014 its Jamshoro does not hold a
14‘s Plant, now valid Drug
Rs. 466.50/pack this plant has Manufacturing
been License for
purchased by Jamshoro site.
GSK
366. S. J. & G. Itonate sr Capsule Form5 Could not be This Deferred for
Fazul Ellahie 150mg 03-04-2014 confirmed formulation evidence of
(Pvt) Ltd., E- (DUPLICATE is rejected by approval of
46, S.I.T.E., Each capsule DOSSIER) Ipride SR Capsule the applied
Karachi contains: PKR 100,000/- by welshire Registration formulation in
Itopride HCl 03-04-2014 Board in its reference
sustained release Rs.330/10‘s Last GMP 250th regulatory
pellets. Eq. to Rs.462/14‘s Inspection meeting. authorities/age
Itopride….150 mg Rs.660/20‘s conducted on 12- ncies as
Gastroprokinetic . 01-2017 with adopted by
agent conclusive remarks Registration
of good level of Board in its
Source of pellets: cGMP compliance. 275th meeting.
Titan
Laboratories, India
367. Zeb Nimulid 100mg Form 5 EMA Approved ● The Registration
Laboratories Tablet Dy No. 3481 Licensing Board
(Pvt) Ltd., Each tablet 14-3-2011 Nims Tablet by Board in its rejected the
Airline contains: PKR 8,000/- Sami 257th applications of
housing Nimesulide…100 (12-3-2011) meeting, M/s Zeb
society, Near mg + considering Laboratories
Cancer (Analgesic) PKR 12,000/- the facts on (Pvt) Ltd.,
Hospital, Post (03-04-2015) the record Airline
Office Thokar 2x10‘s: As per and after housing
Niaz Baig, SRO thread bare society, Near
Lahore deliberation Cancer
368. Zeb Ploymal-F Form 5 NA decided to Hospital, Post
Laboratories Chewable Tablet Dy No. 2040 cancel the Office Thokar
(Pvt) Ltd., Each chewable 14-6-2011 Rubifer by AGP Drug Niaz Baig,
Airline tablet contains: PKR 8,000/- Manufacturi Lahore, since
housing Iron (III) (14-6-2011) ng Licence the Drug
society, Near hydroxide + No. 000122 Manufacturin
Cancer polymaltose PKR 12,000/- by way of g License of
Hospital, Post complex eq. to (03-04-2015) formulation the firm has
Office Thokar elemental 2x10‘s: As per issued in the been cancelled
Niaz Baig, iron….100mg SRO name of M/s by Central
Lahore (Iron supplement) Zeb Licensing
369. Zeb Zecobal Tablet Form 5 Not provided. Laboratories Board.
Laboratories Each tablet Dy No. 3490 (Pvt) Ltd,
(Pvt) Ltd., contains: 14-3-2011 Link
Airline Mecobalamine…. PKR 8,000/- Neuromet Raiwind
housing 500mcg (12-3-2011) Road,
society, Near (Co-Enzyme-Type + Nasirabad
Cancer Vitamin B 12) PKR 12,000/- near Shoukat
Hospital, Post (03-04-2015) Khanum
Office Thokar 2x10‘s: As per Hospital,
Niaz Baig, SRO Lahore on
Lahore the request
of the firm
under
Section 41
of the Drugs
Act, 1976
read with
Rule, 12 of
the Drugs
(Licensing,
Registering
and
Advertising)
Rules, 1976
Evaluator PEC-VII
Name and Brand Name Type Form GMP International Evaluation Decision
Address of Dosage Form Type of Inspection and Me too of 281st
Manufactu Composition Application report Availability meeting
rer / Pharmacologi Demanded
Applicant. cal Group. Price/Pack
Size Initial
Date &
Diary Date
on which
fee becomes
complete
according
to type of
application
/ Form.
370. M/s Vision Cosalz Form 5 Inspection● Source of Approved
SALOFALK
Pharmaceutica 1000mg 17-03-2015 dated 26-1- 1g GASTRO- pellets is with
ls, Plot Sachet Dy.N: 1917 2018, RESISTANT Rashmi innovator‘
# 22-23, Each sachet Rs.20,000/= overall PROLONGE pharma s
Industrial contains: 17-03-2015 GMP was D RELEASE
Triangle Mesalamine Pellet data Good. India specificati
GRANULES on.
Kahuta Road, (Prolong (80,000/-) (MHRA)
Islamabad. Release 19-12-2017
Granules)........ 1x10‘s ● Pentasa of
..........1000mg As Per SRO Atco pharma
(Innovators) (043091)
371. M/s Vision Cosalz 500mg Form 5 Inspection● Me too Deferred

SALOFALK
Pharmaceutica Sachet 17-03-2015 dated 26-1- 500MG reference for
ls, Plot Each sachet Dy.N: 1917 2018, GASTRO- missing. evidence of
# 22-23, contains: Rs.20,000/= overall RESISTANT applied
Industrial Mesalamine 17-03-2015 GMP was PROLONGE Source of formulation
Triangle (Prolong Pellet data Good. D RELEASE pellets is /drug
Kahuta Road, Release (80,000/-) GRANULES already
Rashmi
Islamabad. Granules)........ 19-12-2017 (MHRA) approved
..........500mg 1x10‘s pharma
● NA by DRAP
(Innovators) As Per SRO India.
(generic /
me-too
status)
alongwith
registration
number,
brand name
and name
of firm.
372. M/s Vision Combilyze Form 5 Inspection Evidence of Deferred

Kombiglyze
Pharmaceutica 5/500mg XR 27-03-2015 dated 26-1- Xr Of me too. for
ls, Plot Tablets Dy.N: 2064 2018, Astrazeneca • Need evidence of
# 22-23, Each extended Rs.20,000/= overall Ab (USFDA) stability data applied
Industrial release tablet 10‘s GMP was • Saxagliptin is formulation
Triangle contains: As Per SRO Good. prone to /drug
● NA
Kahuta Road, Saxagliptin (as undergo an already
Islamabad. Hydrochloride intra- approved
)…..5mg molecular by DRAP
Metformin cyclisation (generic /
HCl….500mg reaction in me-too
( Antidiabetic) solution & status)
Innovators solid states to
alongwith
form a cyclic
registration
amidine. The
number,
tablet
formulation brand name
was developed and name
using active of firm.
an active Registratio
coating n Board
process to deferred the
minimize this case for
formation. clarification
Saxagliptin to avoid
was embedded cyclisation
within a film process.
coat of The Board
Opadry spray further,
coated onto decided to
inert core get
tablets. During clarification
the coating
process, from
Saxagliptin previous
free base is registration
converted in- holders of
situ into same
hydrochloride formulation
salt.
Reference:
EMA
373. Al Fazal O-zole 40mg Form 5
Inspection Losec 40 mg Source of Deferred
Pahrma Capsules Not confirmed
dated 25-10- hard gastro- pellets for source
Industries Pvt) Omeprazole Not Confirmed
2017, Firm resistant Missing of pellets,
Ltd, 20-21-22 Pallets Rs. 20,000/-
need further capsules 20mg along with
Defense (8.5% Enteric (Duplicate)
improvemen by Astra stability
●
industrial Coated) 14‘s
t regarding Zeneca UK studies
zone-Moman (Proton Pump As per SRO
documentati Ltd.(MHRA) data, GMP
Pura, 16 km Inhibitor) on, SOP, Losec 40mg certificate
sheikupura (USP) validation capsule by of supplier
Road Lahore, process of M/s Barrett and
(Duplicate) manufacturi Hodgson differential
ng and
fee in case
=quality
of import
control.
of pellets.
However
overall
upgradation
condition
was
satisfactory.
374. Al Fazal Tenafin 1% Form 5 Inspection LAMISIL of Approved.
Pahrma Cream Not confirmed dated 25-10- Novartis Reference
Industries Pvt) Each gram of Not Confirmed 2017, Firm (USFDA) will be sent
Ltd, 20-21-22 cream contain: Rs. 20,000/- to Budget
need further Lamisil cream
Defense Terbinafine (Duplicate) &
industrial HCL…10mg 1‘s improvemen of Novartis
Accounts
zone-Moman (Antifungal) As per SRO t regarding Division
Pura, 16 km JP documentati for
sheikupura on, SOP, verificatio
Road Lahore, validation n of
(Duplicate) process of challan
manufacturi and Board
ng and authorized
=quality its
control. Chairman
for the
However
issuance of
overall
registratio
upgradation n letter.
condition
was
satisfactory
375. Al Fazal NYSTA Form 5 Approved.
Inspection Nystan oral
Pahrma Drops Not confirmed dated 25-10- suspension by Reference
Industries Pvt) Nystatin Not Confirmed 2017, Firm E.R. Squibb will be sent
Ltd, 20-21-22 100,000 IU/ml Rs. 20,000/- need further (MHRA to Budget
Defense (antifungal) (Duplicate) improvemen Approved) &
industrial USP 30 ml t regarding Accounts
zone-Moman As per SRO documentati Division
Nilstat by
Pura, 16 km on, SOP, for
sheikupura Pfizer
validation verificatio
Road Lahore, process of n of
(Duplicate) manufacturi challan
ng and and Board
=quality authorized
control. its
However Chairman
overall for the
upgradation issuance of
condition registratio
was n letter.
satisfactory.
376. Al Fazal
C-Mycin gel Form 5 Inspection Clindamycin Approved.
PahrmaEach gm Not confirmed dated 25-10- gel (USFDA) Reference
Industries Pvt)
contain: Not Confirmed 2017, Firm Clinagel of will be sent
Ltd, 20-21-22
Clindamycin Rs. 20,000/- to Budget
need further GSK
Defense
as (Duplicate) &
indust al zone-
Phosphate....... 30 ml improvemen
Accounts
Moman Pura,
......10gm As per SRO t regarding Division
16 km(Antibiotics) documentati for
sheikupura
USP on, SOP, verificatio
Road Lahore, validation n of
(Duplicate) process of challan
manufacturi and Board
ng and authorized
quality its
control. Chairman
for the
However
issuance of
overall
registratio
upgradation n letter.
condition
was
satisfactory.
377. M/s Genix Fesogen Tabs 03/01/2011 16.2.2018: •Fesoterodine Me too Deferred
Pharma, 44- 4mg Dy. No. 365A Satisfactory Fumarate By reference for
45-B Korangi Each tablet Form 5 level of Zydus missing. evidence of
Creek Road, contains: (Duplicate) cGMP (USFDA) applied
Provided
Karachi Fesoterodine Rs. 8000/- compliance • NA formulatio
fumarate…… Rs.12,000/- reference of
n/drug
…….4mg 19-3-2015 fesoterodon
already
(antimucurinic 10‘s:700/- e , of CCLis approved
receptor) 30‘s:2100/- claimed to by DRAP
(Innovators) be (generic /
conditionall me-too
status)
y approved. alongwith
registratio
n number,
brand
name and
name of
firm.
378. M/s Genix Fesogen 8mg 03-01-2011 16.2.2018: Me too Deferred

● Fesote
Pharma, 44- Tablet Dy.No.36513 Satisfactory rodine reference for
45-B Korangi Each extended Form-5 level of Fumarate By missing. evidence of
Creek Road, release tablet Rs.8000/- cGMP Zydus applied
Provided
Karachi contains: 7-12-2015 compliance (USFDA) formulatio
Fesoterodine Rs.12000/- reference of
● NA n/drug
Fumarate…… 19-3-2015 fesoterodon
already
…....8 mg 10‘s, 30‘s e , of CCLis approved
(Anti As per SRO claimed to by DRAP
Muscuranic be (generic /
Receptor) conditionall me-too
(Innovators)
y approved. status)
alongwith
registratio
n number,
brand
name and
name of
firm.
379. M/s Genix Fluzap 31-01-2011 16.2.2018: Symbyax Approved.
Pharma, 44- 3mg+25mg Dy.No.433 Satisfactory 3mg/25mg Reference
45-B Korangi Capsule Form-5 level of capsule by Eli will be sent
Creek Road, Each capsule (Duplicate) cGMP Lilly (USFDA to Budget
Karachi contains: Rs.8000/- compliance Approved) &
Olanzapine… Rs.12,000/- Me-too status Accounts
…..3 mg 19-3-2015 Co-Depricap Division
Fluoxetine 14‘s: 1680 3/25mg for
HCl eq. to 30‘s: 3600 Capsule by verificatio
Fluoxetine….. M/s Nabi n of
25 mg Qasim challan
(Anti- Industries
and Board
Psychotic) Pvt.Ltd. authorized
USP
its
Chairman
for the
issuance of
registratio
n letter.
Pharma, 44- 6mg+25mg Dy.No.3656 Satisfactory 6mg/25mg Reference
45-B Korangi Capsule Form-5 level of capsule by Eli will be sent
Creek Road, Each capsule Rs.8000/- cGMP Lilly (USFDA to Budget
Karachi contains: Rs.12,000/- compliance Approved) &
Olanzapine… 19-3-2015 Me-too status Accounts
………..6 mg (Duplicate) Co-Depricap Division
Fluoxetine 10‘s Capsule by
HCl eq. to 30‘s M/s Nabi for
Fluoxetine… As per SRO Qasim verificatio
…..25 mg Industries n of
(Anti- Pvt.Ltd. challan
Psychotic) and Board
USP authorized
its
Chairman
for the
issuance of
registratio
n letter.
381. M/s Genix Fluzap 31-01-2011 16.2.2018: Symbyax Me too Deferred
Pharma, 44- 6mg+50mg Dy.No.3655 Satisfactory 6mg/50mg reference for
45-B Korangi Capsule (Duplicate) level of capsule by Eli missing. evidence of
Creek Road, Each capsule Form-5 cGMP Lilly (USFDA applied
Karachi contains: Rs.8000/- compliance Approved) formulatio
Olanzapine… Rs.12,000/- n/drug
………..6 mg 19-3-2015 already
Fluoxetine 14‘s: 1960 approved
HCl eq. to 30‘s: 4200 by DRAP
Fluoxetine….. (Duplicate) (generic /
50 mg me-too
(Anti-
status)
Psychotic)
alongwith
USP
registratio
n number,
brand
name and
name of
firm.
Pharma, 44- 12mg+25mg Dy.No.3651 Satisfactory capsule by Eli Reference
45-B Korangi Capsule Form-5 level of Lilly (USFDA will be sent
Creek Road, Each capsule Rs.8000/- cGMP Approved) to Budget
Karachi contains: Rs.12,000/- compliance Fupine of &
Olanzapine… 19-3-2015 Votex Accounts
……..12 mg 14‘ 30‘s Division
Fluoxetine 14‘s: 1400 for
HCl eq. to 30‘s: 3000 verificatio
Fluoxetine… (Duplicate) n of
…..25 mg challan
(Anti-
and Board
Psychotic)
authorized
USP
its
Chairman
for the
issuance of
registratio
n letter.
383. M/s Genix Fluzap 31-01-2011 16.2.2018: Symbyax Me too Deferred
Pharma, 44- 12mg+50mg Dy.No.436 Satisfactory capsule by Eli reference for
45-B Korangi Capsule Form-5 level of Lilly (USFDA missing. evidence
Creek Road, Each capsule Rs.8000/- cGMP Approved)
of applied
Karachi contains: Rs.12,000/- compliance Me-too status
Olanzapine… 19-3-2015 NA formulatio
…..12 mg n/drug
Fluoxetine already
HCl eq. to approved
Fluoxetine by DRAP
USP….50 mg (generic /
(Anti-
me-too
Psychotic)
(Innovator) status)
alongwith
registratio
n number,
brand
name and
name of
firm
384. M/s Genix Zyprox 80mg 21-03-2011 16.2.2018: Ziprasidone Approved

Pharma, 44- Capsule Dy.No.708 Satisfactory Hydrochloride with
45-B Korangi Each capsule Form-5 level of of Lupin innovator‘
Creek Road, contains: (Duplicate) cGMP (USFDA
s
Karachi Ziprasidone Rs.8000/- compliance Prazip of
HCl……80 Rs.12,000/- specificati
Sharooq
mg 19-3-2015 on.Refere
Pharma
(ANTIPSYCH 14‘s: 1750/- nce will be
OTICS ) 30‘s:3750/- sent to
(Innovator) Budget &
Accounts
Division
for
verificatio
n of
challan
and Board
authorized
its
Chairman
for the
issuance
of
registratio
n letter.

s
Karachi Ziprasidone as Rs.8000/- compliance Ziprox of Nabi
HCl…60 mg Rs.12,000/- specificati
(ANTIPSYCH 19-3-2015 qasim on.Refere
OTICS ) 14‘s: 1652/- nce will be
30‘s:3540/- sent to
Budget &
Accounts
Division
for
verificatio
n of
challan
and Board
authorized
its
Chairman
for the
issuance
of
registratio
n letter

s
Karachi Ziprasidone as Rs.8000/- compliance Ziprox of Nabi
HCl……40 Rs.12,000/- specificati
qasim
mg 19-3-2015 on.Refere
(ANTIPSYCH nce will be
OTICS ) sent to
(Innovator) Budget &
Accounts
Division
for
verificatio
n of
challan
and Board
authorized
its
Chairman
for the
issuance
of
registratio
n letter
387. M/s Genix Azogen Tablet 17/01/2011 16.2.2018: ● Azithromyc Me too Deferred
Pharma, 44- 600mg Dy. No. 188 Satisfactory in of Teva reference for
45-B Korangi Each film Form 5 level of (USFDA missing. evidence of
Creek Road, coated tablet Rs. 8000/- cGMP applied
● NA
Karachi Contains: Rs.12,000/- compliance formulatio
Azithromycin 19-3-2015
dehydrate eq 6‘s: 720 n/drug
to 10‘s; 1200 already
azithromycin approved
(usp)……600 by DRAP
mg (generic /
(Antibacterial) me-too
USP status)
alongwith
registratio
n number,
brand
name and
name of
firm.
388. M/s Genix Serlax 100mg 9-May-2011 16.2.2018: Zoloft 50 mg Approved.
Pharma, 44- Tablet Dy.No.2440 Satisfactory Tablet by M/s Reference
45-B Korangi Each film Form-5 level of Pfizer, will be sent
Creek Road, coated tablet (Duplicate) cGMP (USFDA to Budget
Karachi contains: Rs.8000/- compliance approved) &
Sertraline HCl Rs.12,000/- Me-Too Status Accounts
eq to sertralin 20-8-2015 Ellettra by Division
……..100 mg As per SRO Willshire for
(Anti- verificatio
Depressant) n of
USP challan
and Board
authorized
its
Chairman
for the
issuance of
registratio
n letter.
389. M/s Genix Serlax 50mg 9-May-2011 16.2.2018: Zoloft Tablet Approved.
Pharma, 44- Tablet Dy.No.243e Satisfactory by M/s Pfizer, Reference
45-B Korangi Each film Form-5 level of (USFDA will be sent
Creek Road, coated tablet (Duplicate) cGMP approved) to Budget
Karachi contains: Rs.8000/- compliance Me-Too Status &
Sertralin as Rs.12,000/- Ertaline Tablet Accounts
HCl ……..50 20-8-2015 By M/S Division
mg Genome for
(Anti Pharmaceutica verificatio
Depressant) l n of
USP challan
and Board
authorized
its
Chairman
for the
issuance of
registratio
n letter.
390. M/s Genix Azrol 10mg 10-05-2011 16.2.2018: Approved.
Acitretin of
Pharma, 44- Capsule Dy.No.243B Satisfactory Barr Lab Reference
45-B Each capsule Form-5 level of (USFDA) will be sent
Korangi contains: Duplicate cGMP to Budget
Creek Road, Acitretin…… Rs.8000/- compliance &
Me-too status
Karachi ……10 mg Rs.12,000/- Accounts
(Anti 20-8-2015 Acetin of
Division
psoriasis) 10‘s: 700 Genome
for
USP 30‘s:2100 Pharmaceutica verificatio
ls (Pvt) Ltd n of
challan
and Board
authorized
its
Chairman
for the
issuance of
registratio
n letter.
391. M/s Genix Azrol 25mg 10-05-2011 16.2.2018: Approved.
Acitretin of
Pharma, 44- Capsule Dy.No.243- Satisfactory Barr Lab Reference
45-B Each capsule A level of (USFDA) will be sent
Korangi contains: Form-5 cGMP to Budget
Creek Road, Acitretin…… (Duplicate) compliance &
Me-too status
Karachi ……25 mg Rs.8000/- Accounts
(Anti Rs.12,000/- Acetin of
Division
psoriasis) 20-8-2015 Genome
for
Pharmaceutica verificatio
ls (Pvt) Ltd n of
challan
and Board
authorized
its
Chairman
for the
issuance of
registratio
n letter.
392. M/s Genix Telmis Tabs 17/01/2011 16.2.2018: Micardis by Approved.
Pharma, 44- 80mg Dy. No. Satisfactory Boehringer Reference
45-B Each Tablet 365B level of Ingelheim will be sent
Korangi contains: Form 5 cGMP International to Budget
Creek Road, Telmisartan… (Duplicate) compliance GmbH &
Karachi …….80mg Rs. 8000/- (USFDA) Accounts
( Angiotensin Rs.12,000/- Me-too status Division
II antagonists 19-3-2015 Tasmi by Getz for
) 10‘s:320/- Pharma, verificatio
USP 14‘s: 448/- Karachi n of
challan
and Board
authorized
its
Chairman
for the
issuance of
registratio
n letter.
Pharma, 44- 40mg Dy. No. 365D Satisfactory Boehringer Reference
45-B Korangi Each Tablet Form 5 level of Ingelheim will be sent
Creek Road, contains: (Duplicate) cGMP International to Budget
Karachi Telmisartan… Rs. 8000/- compliance GmbH &
…….40mg Rs.12,000/- (USFDA) Accounts
( Angiotensin 19-3-2015 Me-too status Division
II antagonists 10‘s:200/- Tasmi by Getz for
) 14‘s: 280/- Pharma, Karachi verificatio
USP n of
challan
and Board
authorized
its
Chairman
for the
issuance of
registratio
n letter.
Pharma, 44- 20mg Dy.No.365e Satisfactory Boehringer Reference
45-B Korangi Each Tablet Form 5 level of Ingelheim will be sent
Creek Road, contains: Rs. 8000/- cGMP International to Budget
Karachi Telmisartan… Rs.12,000/- compliance GmbH &
……….20mg 19-3-2015 (USFDA) Accounts
( Angiotensin 10‘s:120/- Me-too status Division
II antagonists 14‘s: 170/- Tasmi by Getz for
) Pharma, Karachi verificatio
USP n of
challan
and Board
authorized
its
Chairman
for the
issuance of
registratio
n letter.
395. M/s Genix Hypoten 5/20 9-05-2011 16.2.2018: Amlodipine Approved.
Pharma, 44- Tablet Dy.No.242e Satisfactory Besylate And Reference
45-B Korangi Each film Form-5 level of Atorvastatin will be sent
Creek Road, coated tablet (Duplicate) cGMP Calcium by to Budget
Karachi contains: Rs.8000/- compliance Mylin &
Amlodipine as Rs.12,000/- (USFDA) Accounts
besylate..5 mg 20-8-2015 Me-Too Status Division
Atorvastatin 7‘s:385/- Am Descol of for
as calcium 14‘s:770/- Nabi Qasim verificatio
……20 mg 20‘s:1100/- Pharma n of
(Anti- challan
Hypertension)
and Board
Innovators
authorized
its
Chairman
for the
issuance of
registratio
n letter.
Pharma, 44- Tablet Dy.No.242D Satisfactory Besylate And Reference
Creek Road, coated tablet (Duplicate) cGMP Calcium by to Budget
Karachi contains: Rs.8000/- compliance Mylin &
Amlodipine as Rs.12,000/- (USFDA) Accounts
besylate…… 20-8-2015 Me-Too Status Division
….5 mg 7‘s:210/- Am Descol of for
Atorvastatin 14‘s:420/- Nabi Qasim verificatio
as 20‘s:600/- Pharma n of
calcium….…. challan
40 mg
and Board
(Anti-
authorized
Hypertension)
its
Innovators
Chairman
for the
issuance of
registratio
n letter.
Pharma, 44- Tablet Dy.No.242F Satisfactory Besylate And Reference
Creek Road, coated tablet Rs.8000/- cGMP to Budget
Calcium by
Karachi contains: Rs.12,000/- compliance &
Amlodipine as 20-8-2015 Mylin
Accounts
besylate……1 7‘s:406/- (USFDA)
Division
0 mg 14‘s:812/- Me-Too Status for
Atorvastatin 20‘s:1160/- Am Descol of verificatio
as Nabi Qasim n of
calcium…….. Pharma challan
20 mg
and Board
(Anti-
authorized
Hypertension)
its
Innovators
Chairman
for the
issuance of
registratio
n letter.
Pharma, 44- Tablet Dy.No.242B Satisfactory Besylate And Reference
Creek Road, coated tablet (Duplicate) cGMP to Budget
Calcium by
Karachi contains: Rs.8000/- compliance &
Amlodipine as Rs.12,000/- Mylin
Accounts
besylate ….10 20-8-2015 (USFDA)
Division
mg 7‘s:455/- Me-Too Status for
Atorvastatin 14‘s:910/- Am Descol of verificatio
as calcium 20‘s:1300/- Nabi Qasim n of
…….10 mg
(Anti- Pharma challan
Hypertension) and Board
Innovators authorized
its
Chairman
for the
issuance of
registratio
n letter.
399. M/s Genix Zoleric 20mg 05-03-2011 16.2.2018: Nexium 40mg Source of Deferred
Pharma, 44- suspension Dy.No.365L Satisfactory packet by M/s pellets for source
45-B Korangi Each sachet Form-5 level of AstraZeneca missing, of pellets,
Creek Road, contains: (Duplicate) cGMP along with
USFDA GMP of
Karachi Esomeprazole Rs.8000/- compliance stability
magnesium Rs.12,000/- Approved) manufactur
studies
trihydrate 19-3-2015 Me-too status er of pellets.
data, GMP
enteric coated 1‘s:65/- Somezol 40mg Certificate certificate
granules eq. to 14‘s: 910/- Sachet by M/s of analysis of supplier
Esomeprazole Bosch of pellets, and
……20 mg (Reg#081611) Real time differential
(Anti-
and fee in case
ulcerative)
accelerated of import
Innovtors
stability of pellets.
study data
of 3 batches
conducted
according to
the
requirement
s of zone
IV-A,
Differential
fee (if the
pellets are
imported)
400. M/s Genix Zoleric 40mg 05-03-2011 16.2.2018: Nexium 40mg Source of `Deferred
Pharma, 44- suspension Dy.No.365M Satisfactory packet by M/s pellets for source
45-B Korangi Each sachet Form-5 level of AstraZeneca missing, of pellets,
Creek Road, contains: (Duplicate) cGMP along with
USFDA GMP of
Karachi Esomeprazole Rs.8000/- compliance stability
magnesium Rs.12,000/- Approved) manufactur
studies
trihydrate 19-3-2015 Me-too status er of pellets.
data, GMP
enteric coated 1‘s128/- Somezol 40mg Certificate certificate
granules eq. to 14‘s: 1800/- Sachet by M/s of analysis of supplier
Esomeprazole Bosch of pellets, and
…..40 mg (Reg#081611) Real time differential
(Anti-
and fee in case
ulcerative)
accelerated of import
Innovators
stability of pellets.
study data
of 3 batches
conducted
according to
the
requirement
s of zone
IV-A,
Differential
fee (if the
pellets are
imported).
GMP.
401. M/s Genix Atrivir 0.5mg 9-05-2011 16.2.2018: Entecavir 0.5 Approved
Pharma, 44- Tablet Dy.No.247-E Satisfactory mg Film- Reference
45-B Korangi Each Film Form-5 level of Coated Tablets will be
Creek Road, Coated tablet Rs.8000/- cGMP sent to
(MHRA
Karachi contains: Rs.12,000/- compliance
Approved) Budget &
Entecavir 20-8-2015
monohydrate 10‘ Me-too status Accounts
equivalent to 30‘ Entecavir by Division
entecavir.…… As per PRC Cirin Pharma for
……0.5 mg verificatio
(Anti-viral) n of
USP challan
and Board
authorized
its
Chairman
for the
issuance
of
registratio
n letter.
402. M/s Genix Atrivir 1 mg 9-05-2011 16.2.2018: Entecavir 1 mg Approved.
Pharma, 44- Tablet Dy.No.242-D Satisfactory Film-Coated Reference
45-B Korangi Each Film Form-5 level of Tablets will be
Creek Road, Coated tablet Rs.8000/- cGMP sent to
(MHRA
Karachi contains: Rs.12,000/- compliance Budget &
Entecavir 20-8-2015 Approved) Accounts
monohydrate 10‘ Me-too status Division
equivalent to 30‘ Entecavir by for
entecavir.…… As per PRC Cirin Pharma verificatio
……1 mg n of
(Anti-viral) challan
USP and Board
authorized
its
Chairman
for the
issuance
of
registratio
n letter.
403. M/s Genix Genpine XR 31-5-2011 16.2.2018: Seroquel XR Approved.
Pharma, 44- 150mg Tablet Dy.No.241B Satisfactory (USFDA) Reference
45-B Korangi Each extended Form-5 level of Me too: will be
Creek Road, release tablet (Duplicate) cGMP Qusel of sent to
Karachi contains: Rs.8000/- compliance Hilton Pharma Budget &
Quetiapine as Rs.12,000/- Accounts
Fumarate…… 20-8-2015 Division
150 mg 10‘s,20‘s, 30‘s for
(Anti As per SRO verificatio
psychotics) n of
USP challan
and Board
authorized
its
Chairman
for the
issuance
of
registratio
n letter.
404. M/s Genix Genpine XR 31-5-2011 16.2.2018: Quetiapine Approved.
Pharma, 44- 300mg Tablet Dy.No.241C Satisfactory Fumarate Reference
45-B Korangi Each extended Form-5 level of (USFDA) will be
Creek Road, release tablet (Duplicate) cGMP Me too: sent to
Karachi contains: Rs.8000/- compliance QUOPINE of Budget &
Quetiapine as Rs.12,000/- Medisure Accounts
Fumarate.300 20-8-2015 Pharma Division
mg 10‘s,20‘s, 30‘s for
psychotics) n of
USP challan
and Board
authorized
its
Chairman
for the
issuance
of
registratio
n letter.
405. M/s Genix Genpine XR 31-5-2011 16.2.2018: Quetiapine Approved.
Pharma, 44- 400mg Tablet Dy.No.241D Satisfactory Fumarate Reference
45-B Korangi Each extended Form-5 level of (USFDA) will be
Creek Road, release tablet (Duplicate) cGMP Me too: sent to
Karachi contains: Rs.8000/- compliance Repose XR Of Budget &
Quetiapine as Rs.12,000/- Maark Pharma Accounts
Fumarate…… 20-8-2015 Division
400 mg 10‘s,20‘s, 30‘s for
psychotics) n of
USP challan
and Board
authorized
its
Chairman
for the
issuance
of
registratio
n letter.
406. M/s Genix Genpine XR 31-5-2011 16.2.2018: Quetiapine Deferred
Pharma, 44- 50mg Tablet Dy.No.241A Satisfactory Fumarate for
45-B Korangi Each extended Form-5 level of (USFDA) evidence of
Creek Road, release tablet (Duplicate) cGMP Me too: applied
Karachi contains: Rs.8000/- compliance NA formulation
Quetiapine as Rs.12,000/- /drug
Fumarate…… 20-8-2015 already
..50 mg 10‘s,20‘s, 30‘s approved
(Anti As per SRO by DRAP
psychotics) (generic /
USP me-too
status)
alongwith
registration
number,
brand name
and name
of firm.
407. M/s Martin Xabatin 0.5mg 04-05-2016 Last GMP Lorazepam of Approved
Dow Ltd. Plot Tablet Dy.No.416 Inspection Par pharm Reference
# 37, Sector Each tablet Form-5 was (USFDA) will be
19, Korangi contains: Rs.20,000/- sent to
Conducted Me to:
industrial Lorazepam…. (Duplicate)
on 27-12- Veniti Budget &
area, Karachi .0.5mg 10‘s
(Benzodiazepi 30‘s 2017 with Wilshire Accounts
ne derivatives) 100‘s conclusive Laboratories Division
USP As per SRO remarks of for
good level verificatio
of cGMP n of
compliance. challan
and Board
authorized
its
Chairman
for the
issuance
of
registratio
n letter.
408. M/s Martin Fansidar Plus 28-03-2011 Last GMP WHO approved Approved
Dow Ltd. Plot Tablet Dy.No.3231 Inspection formulation with
# 37, Sector 50/50/25 (R&I) was Me-too status innovator‘
19, Korangi Each tablet Form-5
Conducted SP- s
industrial contains: Rs.8000/-
area, Karachi Artesunate Rs.12000/- on 27-12- MALFocous specificati
…..50mg (Duplicate) 2017 with & Rulz on.
Sulfadoxine 31-7-2013 conclusive Pharmaceutica Reference
….500 mg 3x1‘s remarks of ls will be
Pyrimethamin 45/- good level sent to
e …..25mg of cGMP Budget &
(Antimalarial)
Innovators compliance. Accounts
Division
for
verificatio
n of
challan
and Board
authorized
its
Chairman
for the
issuance
of
registratio
n letter.
409. M/s Ciba M-Oxin 30-8-2016 Latest GMP Avelox 400 Firm has 6 Approved
Pharmaceutic 400mg/250ml Dy.no.835 inspection mg/250 ml sections and with
als, A-371, Infusion Form-5 dated 14-6- solution for they claim change of
Nooriabad Each vial Rs.20,000/- 2017 brand name
infusion by that no
site contains: Rs.30,000/- showing & with
Industrial Moxifloxacin (Duplicate) good cGMP M/s Bayer plc, registration
Innovators
area, as HCl….400 7-9-2016 compliance. MHRA on contract
specificatio
superhighwa mg As per SRO approved bases in the ns.Referen
y (Anti biotic) Me-too status name of ce will be
(Hyderabad) Innovators Mofest ciba pharma
Karachi. sent to
Infusion is approved Budget &
Contract by
by DRAP Accounts
M/s ISIS
Pharmaceutic Division
als and for
chemicals verificatio
25/1-3 sector
n of
12-C, North
Karachi challan
industrial and Board
area, Karachi authorized
its
Chairman
for the
issuance
of
registratio
n letter.
410. M/s Ciba Cixime 200mg 26-8-2016 Latest GMP Cefixime 200 Firm has 6 Approved
Pharmaceutica Tablet Dy.no.837 inspection mg film sections and with
ls, A-371, Each Film Form-5 dated 14-6- coated tablet they claim change of
Nooriabad site coated tablet Rs.20,000/- 2017 brand name
(MHRA) that no
Industrial contains: Rs.30,000/- showing Reference
area, Cefixime as (Duplicate) good cGMP Caricef sami registration
will be
superhighway trihydrate 7-9-2016 compliance. pharmaceutica on contract
sent to
(Hyderabad) ….200 mg As per SRO ls bases in the
Karachi. (Antibiotic) name of Budget &
Contract by USP ciba pharma Accounts
M/s ISIS is approved Division
Pharmaceutica by DRAP for
ls and verificatio
chemicals
n of
25/1-3 sector
12-C, North challan
Karachi and Board
industrial authorized
area, Karachi its
Chairman
for the
issuance
of
registratio
n letter.
411. M/s Ciba Cixime Duplicate Latest GMP Cefixime of Firm has 6 Approved
Pharmaceutica 100mg/5ml Form-5 inspection Lupan sections and with
ls, A-371, Suspension Rs.20,000/- dated 14-6- (USFDA they claim change of
Nooriabad site Each 5ml (29-aug-2016) 2017 Approved) that no brand name
Industrial contains: Rs.30,000/- showing Me-too status registration Reference
area, cefixime as (2nd sep-2016) good cGMP Akurate Envoy on contract will be
superhighway trihydrate 7-9-2016 compliance. Pharma bases in the sent to
(Hyderabad) ……100 mg As per SRO name of Budget &
Karachi. (Anti biotic) ciba pharma Accounts
Contract by USP is approved Division
M/s ISIS (Duplicate) by DRAP for
ls and n of
chemicals challan
25/1-3 sector and Board
12-C, North authorized
Karachi its
industrial Chairman
area, Karachi for the
issuance
of
registratio
n letter.
412. M/s Ciba Cixime 30-8-2016 Latest GMP Cefixime of Firm has 6 Approved
Pharmaceutica 200mg/5ml Dy.no.836 inspection Lupan sections and with
ls, A-371, Suspension Form-5 dated 14-6- (USFDA they claim change of
Nooriabad site Each 5ml Rs.20,000/- 2017 Approved) that no brand name
Industrial contains: Rs.30,000/- showing Me-too status registration Reference
area, cefixime as 7-9-2016 good cGMP Efix of on contract will be
superhighway trihydrate compliance. Highnoon bases in the sent to
(Hyderabad) ……200 mg As per SRO name of Budget &
Karachi. (Anti biotic) ciba pharma Accounts
Contract by USP is approved Division
M/s ISIS by DRAP for
ls and n of
chemicals challan
Karachi its
industrial Chairman
issuance
of
registratio
n letter.
413. M/s Ciba Cixime 400mg 30-8-2016 Latest GMP Suprax by Firm has 6 Approved
Pharmaceutica Capsule Dy.no.831 inspection Lupins sections and with
ls, A-371, Each capsule Form-5 dated 14-6- (USFDA they claim change of
Nooriabad site contains: Rs.20,000/- 2017 Approved) that no brand name
Industrial cefixime as Rs.30,000/- showing Me-too status registration Reference
area, trihydrate (Duplicate) good cGMP Agrofix Agror on contract will be
superhighway ….400 mg 7-9-2016 compliance. Pharma bases in the sent to
(Hyderabad) (Antibiotic) As per SRO name of Budget &
Karachi. JP ciba pharma Accounts
Contract by is approved Division
ls and n of
chemicals challan
Karachi its
industrial Chairman
issuance
of
registratio
n letter.
414. M/s Ciba Ferona 30-8-2016 Latest GMP Venofer of Firm has 6 Approved
Pharmaceutica 100mg/5ml Dy.no.832 inspection Luitpold sections and with
ls, A-371, Injection Form-5 dated 14-6- (USFDA) they claim change of
Nooriabad site Each ml Rs.20,000/- 2017 Me-too status that no brand name
Industrial contains: Rs.30,000/- showing Axifer of Nova registration Reference
area, Iron Sucrose (Duplicate) good cGMP Med1 on contract will be
superhighway eq. to 7-9-2016 compliance. bases in the sent to
(Hyderabad) elemental name of Budget &
Karachi. iron……..100 ciba pharma Accounts
Contract by mg is approved Division
Pharmaceutica (Replenishes verificatio
ls and Hgb and n of
chemicals depleted iron challan
25/1-3 sector stores) and Board
12-C, North USP authorized
Karachi its
industrial Chairman
issuance
of
registratio
n letter.
415. M/s Ciba Cibamin 30-8-2016 Latest GMP COMESGEN Firm has 6 Approved
Pharmaceutica 500mcg/ml Dy.no.833 inspection Injection 500 sections and Reference
ls, A-371, Injection Form-5 dated 14-6- μg by M/s they claim will be
Nooriabad site Each ml Rs.20,000/- 2017 Tatsumi that no sent to
Industrial contains: Rs.30,000/- showing Chemical registration Budget &
area, Mecobalamin (Duplicate) good cGMP Co, PMDA on contract Accounts
superhighway ……500mcg 7-9-2016 compliance. approved bases in the Division
(Hyderabad) (Vitamine B) Me-too status name of for
Karachi. Innovators Mecoborn ciba pharma verificatio
Contract by Injection is approved n of
M/s ISIS 500mcg/ml by by DRAP challan
Pharmaceutica M/s Wellborne and Board
ls and (Reg#054885) authorized
chemicals its
25/1-3 sector Chairman
12-C, North for the
Karachi issuance
industrial of
area, Karachi registratio
n letter.
416. M/s Ciba Tritop 1gm 30-8-2016 Latest GMP Ceftriaxone of Firm has 6 Approved
Pharmaceutica Injection IV Dy.no.839 inspection sandoz sections and with
ls, A-371, Each vial Form-5 dated 14-6- (USFDA) they claim change of
Nooriabad site contains:- Rs.20,000/- 2017 Me-too status that no brand name
Industrial Ceftriaxone Rs.30,000/- showing 3-zone of Zeb registration Reference
area, Sodium eq. to (Duplicate) good cGMP on contract will be
superhighway Ceftriaxone… 7-9-2016 compliance. bases in the sent to
(Hyderabad) …….. 1gm As per SRO name of Budget &
Karachi. ( ciba pharma Accounts
Contract by Cephalosporin is approved Division
M/s ISIS ) by DRAP for
Pharmaceutica (with ampoule verificatio
ls and of WFI, I.V n of
chemicals Inj.) challan
25/1-3 sector USP and Board
Karachi its
industrial Chairman
issuance
of
registratio
n letter.
417. M/s Ciba Tritop 250mg 30-8-2016 Latest GMP Ceftriazone of Firm has 6 Approved
Pharmaceutica Injection IV Dy.no.835 inspection sandoz sections and with
ls, A-371, Each vial Form-5 dated 14-6- (USFDA) they claim change of
Nooriabad site contains: Rs.20,000/- 2017 Me-too status that no brand name
Industrial Ceftriaxone Rs.30,000/- showing 3-zone of Zeb registration Reference
area, Sodium eq. to (Duplicate) good cGMP on contract will be
superhighway Ceftriaxone 7-9-2016 compliance. bases in the sent to
(Hyderabad) …250mg name of Budget &
Karachi. ( ciba pharma Accounts
Contract by Cephalosporin is approved Division
M/s ISIS ) by DRAP for
Pharmaceutica USP verificatio
ls and n of
chemicals challan
Karachi its
industrial Chairman
issuance
of
registratio
n letter.
418. M/s Ciba Tritop 500mg 30-8-2016 Latest GMP Rocephin Firm has 6 Approved
Pharmaceutic Injection IV Dy.no.838 inspection powder for sections and with
als, Karachi Each vial Form-5 dated 14-6- solution for they claim change of
Toll by M/s contains: Rs.20,000/- 2017 injection by that no brand name
ISIS Ceftriaxone Rs.30,000/- showing Roche registration Reference
Pharmaceutic Sodium…500 (Duplicate) good cGMP (MHRA on contract will be
als, Karachi. mg 7-9-2016 compliance. Approved) bases in the sent to
(Anti biotic) As per SRO Me-too status name of Budget &
(with ampoule Cefxone by ciba pharma Accounts
of WFI, I.V Bosch is approved Division
Inj.) by DRAP for
(Antibiotic) verificatio
USP n of
challan
and Board
authorized
its
Chairman
for the
issuance
of
registratio
n letter.
Evaluator PEC-IV
419. Lotus Lotocef 1gm Form 5 Cefotaxime Deferred for

Pharmaceuticals Injection Dy. No. 8364 powder for evidence of
(Pvt) Ltd, Plot # Cefotaxime as 23-12-2013 solution for approved
118-A, Street # (sodium)..........1gm Rs. 20,000/- injection of
manufacturing
08, I-10/3, MHRA approved
Industrial Area, Cephalosporin 1‘s facility for “Dry
Islamabad As per SRO Exoran of M/s powder
(USP Specs) City Pharma Injection
(cephalosporin)
Last inspection ” section.
report dated
1-08-2017
confirms
satisfactory
compliance to
GMP
420. Lotus Lotocef 250mg Form 5 Cefotaxime Deferred for
Pharmaceuticals Injections Dy. No. 8352 powder for evidence of
(Pvt) Ltd, Plot # Each vial contains: 23-12-2013 solution for approved
118-A, Street # Cefotaxime as Rs. 20,000 injection of
manufacturing
08, I-10/3, (sodium)......... MHRA approved
Industrial Area, 250mg 1‘s facility for “Dry
Cephalosporin City Pharma Injection
(cephalosporin)
(USP Specs) Last inspection ” section.
report dated 1-
08-2017
confirms
satisfactory
compliance to
GMP
421. Lotus Lotocef 500mg Form 5 Cefotaxime Deferred for
Pharmaceuticals Injections Dy. No. 8363 powder for evidence of
(Pvt) Ltd, Plot # Each vial contains: 23-12-2013 solution for approved
118-A, Street # Cefotaxime as Rs. 20,000 injection of
manufacturing
08, I-10/3, (sodium).......... MHRA approved
Industrial Area, 500mg 1‘s facility for “Dry
City Pharma Injection
Cephalosporin (cephalosporin)
Last inspection ” section.
(USP Specs) report dated 1-
08-2017
confirms
satisfactory
compliance to
GMP
422. M/s Mafins Clobetsol 0.05% 9-6-2015 Dermovate Approved with
Karachi. Cream Dy.no.313 0.05% W/W innovator’s
Each gm contains: Form-5 Cream of specification.
Clobetasol Rs.20,000/-(Duplicate (MHRA
Reference will
Propionate…0.05% Dossier) approved)
Clobate Cream be sent to
Topical 5gm RS; 25/- of M/s Meditech Budget &
Corticosteroid 10gm RS: 34.50/- Pharmaceuticals Accounts
15gm RS; 45/- Division for
Manufacturer Spec 30gm RS; 80/- Last inspection verification of
report dated 05- challan and
10-2017 with
Board
conclusive
remarks of good authorized its
cGMP Chairman for
compliance the issuance of
registration
letter.
423. M/s Mafins Fosfo 500mg 9-6-2015 Fosfomicina Approved with
Karachi. Capsule Dy.no.311 calcica solufos innovator’s
Each capsule Form-5 500mg capsule specification.
contains: Rs.20,000/-(Duplicate by Spain
Reference will
Fosfomycin…..500 Dossier)
mg Dart Capsules of be sent to
10‘s RS; 125/- M/s Medicraft Budget &
Anti Bacterial 12‘s RS: 170/- Pharmaceuticals Accounts
Agent 50‘s RS; 283/- Division for
100‘s RS; 1000/- Last inspection verification of
Manufacturer‟s report dated 05- challan and
specifications 10-2017 with
Board
conclusive
remarks of good authorized its
cGMP Chairman for
registration
letter.
424. M/s Mafins Fucid 2% Cream 9-6-2015 Fucidin cream Approved.
Karachi. Each gm contains: Dy.no.314 of (MHRA Reference will
Fusidic Form-5 approved) be sent to
Acid…………2% Rs.20,000/-(Duplicate
Budget &
Anti-bacterial Dossier Hifuzin Cream
of M/s Hiranis Accounts
BP 5gm RS; 73/- Division for
10gm RS: 105/- Last inspection verification of
15gm RS; 240/- report dated 05- challan and
10-2017 with Board
conclusive authorized its
remarks of good
Chairman for
cGMP
registration
letter.
425. M/s Mafins Modiam 2mg 9-6-2015 Lomodine 2mg Approved.
Karachi. Capsule Dy.no.315 Capsules of Reference will
Each capsule Form-5 (MHRA be sent to
contains: Rs.20,000/-(Duplicate approved)
Budget &
Loperamide Dossier) Lopim of Rock
HCl….2 mg Pharmaceuticals Accounts
10‘s RS; 27/- Last inspection Division for
Antidiarrheal Agent 20‘s RS: 63/- report dated 05- verification of
50‘s RS; 100/- 10-2017 with challan and
(USP Specs) 60‘s RS; 190/- conclusive Board
100‘s RS; 232/-200‘s remarks of good authorized its
RS; 582/- cGMP
Chairman for
compliance
the issuance of
registration
letter.
426. M/s Mafins Monti 10mg Tablet 9-6-2015 Singulair 10-mg Approved.
Karachi. Each film coated Dy.no.312 of ( USFDA
tablet contains: Form-5 approved) Reference will
Montelukast (as Rs.20,000/-(Duplicate
be sent to
sodium)………10 Dossier) Montifaas 10mg
mg Tablet M/s Faas Budget &
10‘s RS; 310/- Pharmaceuticals Accounts
Leukotriene 14‘s RS: 401/- Division for
receptor antagonist 20‘s RS; 443/-30‘s Last inspection verification of
RS; 670/- report dated 05- challan and
(USP Specs) 10-2017 with Board
conclusive
authorized its
remarks of good
cGMP Chairman for
registration
letter.
427. M/s Mafins Motemium 10mg 9-6-2015 Motilium 10 Mg Approved with
Karachi. Tablet Dy.no.316 Tablets of M/s innovator’s
Each film coated Form-5 (TGA approved) specification.
tablet contains: Rs.20,000/-(Duplicate
Reference will
Domperidone……1 Dossier) Stomacol of M/s
0 mg High-Q be sent to
5‘s RS; 215/- Budget &
(Antiemetic) 10‘s RS: 244/- Last inspection Accounts
30‘s RS; 315/-50‘s report dated 05- Division for
Manufacturer RS; 475/- 10-2017 with verification of
specification conclusive
challan and
remarks of good
cGMP Board
compliance authorized its
Chairman for
the issuance of
registration
letter.
428. M/s. Jaens Lesplate 75mg Dy. No. 15494/ (R&I) Cadix 75mg of Approved with
Pharma Lahore Tablet Dated 19-09-2017 (MHRA innovator’s
Each film tablet (Duplicate Dosssier) approved) specification.
contains;
Reference will
Clopidogrel as 1 x10‘s Clorel 75mg
(hydrogen RS; 140/- tablet of M/s be sent to
sulphate)….75mg Mission Budget &
Accounts
Platelet aggregation Last inspection Division for
inhibitors report dated 20- verification of
12-2017 with challan and
(Manufacturer conclusive
Board
Specs) remarks that firm
is operating at authorized its
satisfactory level Chairman for
og GMP the issuance of
compliance registration
letter.
429. M/s. Jaens Moxbay 400mg Dy. No. 15496/ (R&I) Avelox 400 mg Approved with
Pharma Lahore tablet Dated 19-09-2017 of (MHRA innovator’s
Each film tablet (Duplicate Dosssier) approved) specification.
contains;
Reference will
Moxifloxacin as 1 x 5‘s Moxox 400mg of
(HCl) eq to RS: 690/- M/s Wellborne be sent to
Moxifloxacine…… Pharmachem and Budget &
.400mg Biologicals, Accounts
Division for
Antibiotic Last inspection verification of
report dated 20- challan and
(Manufacturer 12-2017 with
Board
Specs) conclusive
remarks that firm authorized its
is operating at Chairman for
satisfactory level the issuance of
og GMP registration
compliance letter.
430. M/s. Jaens Vastin 05mg Dy. No. 15495/ (R&I) Crestor 5mg of Approved with
Each Flm coated (Duplicate Dosssier) Approved) specification.
tablet contain
Reference will
Rosuvastatin as ( Rosocard Tablets
Rosuvastatin of M/s Himont be sent to
calcium)……5mg Pharma Budget &
Accounts
Antihyperlipidemic Last inspection Division for
report dated 20- verification of
(Manufacturer 12-2017 with challan and
Specs) conclusive
Board
remarks that firm
letter.
431. M/s. Jaens Vastin 10mg Dy. No. 15497/ (R&I) Crestor 10mg of Approved with
Each Flm coated (Duplicate Dosssier) Approved) specification.
tablet contain
Reference will
Rosuvastatin as ( 1 x 10‘s Rosocard Tablets
Rosuvastatin RS; 200/- of M/s Himont be sent to
calcium)……10mg Pharma Budget &
Accounts
Antihyperlipidemic Last inspection Division for
report dated 20- verification of
(Manufacturer 12-2017 with challan and
Specs) conclusive
Board
remarks that firm
letter.
432. M/s.The Schazoo Endure 25mg Form 5-D Licosil 25mg of Deferred as
Pharma Tablet (MHRA formulation is
Sheikhpura Each film coated Dy. No. 16306/ (R&I) approved) under review
tablet contain Dated 27-09-2017
Sildenafil as(citrate) (Duplicate Dossier)
U.S.P……..25mg 2 x 5‘s
RS; 750/pack
Manufacture Spec RS; 75/tablet
433. M/s.The Schazoo Endure 50mg Form 5-D Licosil 50mg of Deferred as
Pharma Tablet (MHRA formulation is
Sheikhpura Each film coated Dy. No. 16307/ (R&I) approved) under review
tablet contain Dated 27-09-2017
Sildenafil as(citrate) (Duplicate Dossier)
U.S.P……..50mg 2 x 5‘s
RS; 1000/ pack
Manufacture Spec RS; 100/tablet
434. M/s.The Schazoo Zeal 10mg Tablet Form 5-D Tadalafil 20mg Deferred as
Pharma Each film coated Dy. No. 16311/ (R&I) (MHRA formulation is
Sheikhpura tablet contain Dated 27-09-2017 approved under review
Tadalafil (Duplicate Dossier)
U.S.P……..10mg
2 x 5‘s
USP Spec RS; 2000/ pack
RS; 200/tablet
435. M/s.The Schazoo Zeal 20mg Tablet Form 5-D Tadalafil 20mg Deferred as
Pharma Each film coated (MHRA formulation is
Sheikhpura tablet contain Dy. No. 16312/ (R&I) approved) under review
Tadalafil Dated 27-09-2017
U.S.P……..20mg (Duplicate Dossier)
2 x 5‘s
USP Spec RS; 1500/ pack
RS; 150/tablet
436. M/s.The Schazoo Zealus 20mg Tablet Form 5-D Verdenafil Deferred as
Pharma Each film coated Accord 20mg of formulation is
Sheikhpura tablet contain Dy. No. 16310/ (R&I) (MHRA under review
Verdenafil as (HCl Dated 22-09-2017 approved)
trihydrate)U.S.P… (Duplicate Dossier)
…..20mg
2 x 5‘s
Manufacture Spec RS; 2000/ pack
RS; 200/tablet
437. Mass Pharma Amodip-V Plus Form 5 Exforge Hct Of ( Approved with
(Private) Tablet Not Confirmed USFDA innovator’s
Limited, Lahore Each film coated Not Confirmed Approved) specification.
tablet contain Rs. 20,000/-
Amlodipine.....5mg (Duplicate Dossier) Exforge Hct Of
Valsartan......160mg M/S Novartis Reference will
Hydrochlorothiazid 2 x7‘s Pharma be sent to
e..............12.5mg Not provided Budget &
Last inspection Accounts
(Anti-hypertensive) was conducted Division for
on 11-09-2017 verification of
Manufacturer‘s which concludes
challan and
specification a ―fair‖
level of GMP Board
compliance authorized its
Chairman for
the issuance of
registration
letter.
438. Mcolson M-GAB 150mg Form 5 Lyrica of Approved with
Reasearch Capsule Dy. No. 131 (USFDA innovator’s
Laborotaries, Each capsule 02-11-2016 approved) specification.
Sheikupura, contains: Rs. 20,000/-
Lahore Pregabalin........150 Gabica Capsule
mg 14‘s by M/s Getz
As per SRO Pharma
(Anti-epileptic)
Last GMP
(Manufacturer inspection is
Specs) conducted on 10-
04- 17 & 24-04-
2017 and the
report concludes
that overall firm
has fair
compliance of
GMP
439. Mcolson M-GAB 50mg Form 5 Lyrica of Approved with
Reasearch Capsule Dy. No. 134 (USFDA innovator’s
Laborotaries, Each capsule 02-11-2016 approved) specification.
Sheikupura, contains: Rs. 20,000
Lahore Pregabalin.....50mg Gabica Capsule
14‘s by M/s Getz
(Anti-epileptic) As per SRO Pharma
Last GMP
(Manufacturer inspection is
Specs) conducted on 10-
04- 17 & 24-04-
2017 and the
report concludes
that overall firm
has fair
compliance of
GMP
440. Medisave Rosun Tablet 40mg Form 5 Crestor 40mg of Approved with
Pharmaceuticals, Each film coated Dy. No. 1099 (MHRA innovator’s
Lahore tablet contains: 12-10-2015 Approved) specification.
Rosuvastatin Rs. 20,000
.........40mg Rosocard Tablets
10‘s of M/s Himont
Antihyperlipidemic As per SRO Pharma
(Manufacturer The firm was

Specs) granted GMP
certificate based
upon inspection
conducted on 11-
12-2017 & 10-
01-2018 and
recommended
for renewal of
DML.
441. Medisave Vabrasave Tablet Form 5 Corlanor of Approved with
Pharmaceuticals, 5mg Dy. No. 1090 (USFDA innovator’s
Lahore Each film coated 12-08-2015 approved) specification.
tablet contains: Rs. 20,000
Ivabradine Iva Tablet 5 mg
Hydrochloride eq. 14‘s by M/s CSH
to As per SRO
Ivabradine........5mg
Pharmaceuticals
Anti anginal The firm was
granted GMP
(Manufacturer certificate based
Specs) upon inspection
conducted on 11-
12-2017 & 10-
01-2018 and
recommended
for renewal of
DML.
b. Deferred cases
Evaluator PEC-II
442. Name and address of manufacturer / M/s. CCL Pharmaceuticals (Pvt.) Ltd. Lahore
Applicant
Brand Name +Dosage Form + Strength BPH Capsules
Composition Each capsule contains:-
Dutasteride….0.5mg
Tamsulosin HCl….0.4mg
(Dutasteride soft gelatin capsule & Tamsolucin HCl
extended release pellets have been used)
Diary No. Date of R& I & fee Dy.No. 973 , dated 27-09-16; Original fee challan of Rs.
100,000/-;Dated 21/09/16
Pharmacological Group Drugs Used In Benign Prostatic Hyperplasia
Type of Form Form-5
Finished product Specification The firm has claimed manufacturer‘s specifications.
Pack size & Demanded Price 01 x 10‘s,02 x 07‘s,02 x 10‘s, 03 x 10‘s;
As per brand leader
Approval status of product in Reference Combodart 0.5 mg / 0.4 mg hard capsules of M/s GSK,
Regulatory Authorities. (approved by MHRA of UK)
Me-too status DUODART of M/s GSK, Karachi
GMP status Last inspection report dated 8-3-2017 confirms satisfactory
compliance to GMP
Previous Remarks of the Evaluator. Firm has submitted following :
● Original legalized CoPP of Prelone soft capsules
(Dutasteroid 0.5mg) (certificate No. 767/GP-WD)
issued by Ministry of health of Vietnam, dated 03-08-
2017.
● Submitted CoPP confirms the GMP status of
manufacturer of Dutasteroid 0.5mg soft gel capsules i.e.
M/s Phil Inter Pharma Co., Ltd, Thuan An District,
Vietnam.
● COA & Stability Studies of Dutasteroid 0.5mg soft gel
capsules.
● Copy of legalized GMP certificate of M/s Lee Pharma
Ltd. (supplier of Tamsulocin pellets 0.2% w/w
Sustained release) valid upto 10-04-2017.
● Moreover firm has stated that they have HJ semi-
automatic capsule machine of China to manufacture
said product. (pictures of machine have been shared.)
Previous Decision of Registration Board Registration Board in its 274th meeting deferred for
following:
● Submission of Original valid Legalized GMP certificate
of M/s Lee Pharma Ltd. (supplier of Tamsulosin pellets
0.2% w/w Sustained release).
● Availability of manufacturing facility for filling of soft
gelatin dutasteride capsule in hard gelatin capsules
along with tamsulosin pellets as semi-automatic capsule
machine is not suitable for manufacturing of applied
formulation
Evaluation PEC i. Firm has submitted original legalized GMP
certificate (Certificate No.
354/DD/DCA/VSP/2017) issued by DCA
Andhrapardesh, valid upto 02-04-2018.
ii. Moreover, Firm has stated that initially they had
semi-automatic capsule machine for powder/pellets
filling but now we have modified it to semi-
automatic capsule in capsule filling machine by
adding extra hopper for the filling of soft-gel
capsules to put inside the body of hard gelatin
capsules which are latterly filled with pellets.
iii. Firm has submitted DQ, IQ, OQ & PQ report of
said semi-automatic capsule filling machine.
Decision of 276th RB Meeting: Registration Board deferred the case for following:
i. Verification of capsule filling machine for filling of soft gel capsule in hard gel capsule
along with pellets, by area FID.
ii. Further deliberation for import of soft gelatin Dutasteride capsules.
In 279th meeting the following inspection report for Verification of capsule filling machine for filling of
soft gel capsule in hard gel capsule along with pellets, by area FID was presented:
Date of Visit: 9th February, 2018

Name of Inspector: Uzma Barkat (Federal Inspector of Drugs, Lahore)
Name of firm representative accompanying during inspection:
Dr Rizwan Mahmood, Director, Quality Operations

Mr Irfan Sohail, Senior Manager, Regulatory Affairs
Mr Shahid, Senior Manager, R & D
Mr Farhan Qureshi, Quality Assurance Manager
Mr Fiaz, Quality Control Manager
● Details of Inspection
M/s CCL Pharmaceuticals Pvt. Ltd., Lahore was visited on 9 th February, 2018, for verification of capsule
filling machine with reference to decision of the DRB in its 276 th meeting conveyed vide DRAP, Islamabad
letter no. F.2-16/2016-PEC (M-276) dated 12th January, 2018. The said machine was intended to be used for
the purpose of filling of soft gelatin capsule in hard gelatin capsule along with pellets in the firm‘s product
BPH Capsules (Dutasteride soft gelatin capsules + Tamsulosin HCl pellets) for which the firm had applied for
registration.
As informed by the firm management, the Semi-Automatic Capsule Filling Machine, already installed in the
firm, had been modified in December, 2016, to serve the purpose of Semi-Automatic Capsule in Capsule
Filling Machine by adding an additional hopper and feeder for filling of Dutasteride soft gelatin capsules in to
the hard gelatin capsules.
The manufacturing facility as well as the relevant equipment related documents like qualification documents
and calibration certificates were seen. The modified machine consisted of various parts like
● Hopper and feeder for filling of hard gelatin capsules
● Hopper and feeder for filling of pellets
● Hopper and feeder for filling of soft gelatin capsules
● Filling plate for the filling of hard gelatin capsules
● Locking and ejection mechanism
Capsule filling operation of trial batch no. T5/18 (Batch size: 2500 capsules) was witnessed during the visit.
First, the caps of the hard gelatin capsules were separated from the bodies. Then Dutasteride soft gelatin
capsules were filled in to the hard gelatin bodies followed by filling of Tamsulosin HCl pellets, pneumatic
locking of hard gelatin capsule cap and body and ejection of filled capsules. A sample of the trial batch was
checked for physical parameters. Physical appearance and locking of capsules of this batch was found
satisfactory and weight variation of filled capsules and individual content weight of Tamsulosin HCl pellets
and Dutasteride soft gelatin capsules was within the specified range.
Performance qualification report (with addendum) of the modified machine comprised of the physical test
results (physical appearance and locking of capsule, filled capsule weight, content weight of Tamsulosin
pellets, content weight of Dutasteride soft gelatin capsules) and chemical test results of one trial batch no. T-
4/18 (Batch Size: 2500 capsules).
● Conclusion
Based on the verification of the manufacturing facility, it is concluded that encapsulation of Tamsulosin
pellets and Dutasteride soft gelatin capsules in hard gelatin capsules can be satisfactorily achieved using the
modified Semi-Automatic Capsule Filling Machine subject to regular in process checks and strict process
control.
The inspection was limited to the verification of manufacturing facility. Other parameters and related
documentary requirements like product development, trial data, dissolution profile, test methods, analytical
method and process validation may be checked / verified by the concerned quarter
Decision of 279th meeting: Registration Board deferred the case for further deliberation for import of
soft gelatin Dutasteride capsules.
Evaluation by PEC: Now the firm has submitted as under:
―Dutasteride soft gelatin capsule is a ready to fill ―Raw material‖ like pellets. Our Dutasteride soft –gelatin
capsule is form MHRA approved source i.e. M/s Phil Inter Pharma Company Ltd. No. 20 HUU NGHI
Boulevard VSIP Thuan AN, BInh Duong, Vietnam. So it is requested to approve our source of Dutasteride
Soft gel capsule as ready to fill active API.
The GMP certificate of MHRA for M/s Phil Inter Pharma Company Ltd. No. 20 HUU NGHI Boulevard VSIP
Thuan AN, BInh Duong, Vietnam referred by firm has been verified from following web link as accessed on
14-03-2018:
http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPCompliance.do?ctrl=searchGMPCResultContro
lList&action=Drilldown&param=39282
The certificate states that from the knowledge gained during inspection of this manufacturer, the latest of
which was conducted on 2016-10-11 , it is considered that it complies with :
● The principles and guidelines of Good Manufacturing Practice laid down in Directive 2003/94/EC
This certificate reflects the status of the manufacturing site at the time of the inspection noted above and
should not be relied upon to reflect the compliance status if more than three years have elapsed since the date
of that inspection.
The name of manufacturer of Dutasteride soft gelatin capsules has been verified for original legalized COPP
submitted by firm.
Decision of 281st meeting: Registration Board deferred the case for submission of latest GMP inspection
report conducted within last one year. Moreover, Registration Board deliberated about manufacturing
requirement for applied formulation which involves filling of Dutasteride soft gelatin capsule into a
hard gelatin capsule containg Tamsulosin pellets. Currennlty Dutastreride soft gelatin capsule, which is
a steroidal preparation is being filled in the hard gelatin capsule in the General capsule section. The
Board deliberated upon this manufacturing practice and decided that a panel may visit the applicant
along with other manufacturers having registered products o fapplied formulation for following
observations:
i. Suitability of capsule filling machine for manufacturing of applied product.
ii. Measures taken in case of spillage after rupturing of soft gelatin Dutasteride capsule and details
regarding its cleaning validation processes and impact of cross contamination and
environmental hazards, as the filling of Dutateride soft gelatin capsule in the hard gelatin
capsule shells will be processed in general capsule section shells will be processed in general
capsule section
Composition of panel:
a. Additioanl Director DRAP (E&M) Office.
b. Area FID.
Evaluator PEC-XIV
Case No.3 Review of Duloxetine EC pellets by M/s. Vision Pharma
Registration Board in its various meetings deferred cases for clarification whether the
Duloxetine pellets of M/s. Vision Pharmaceuticals are of USP grade or otherwise. Recently, the
supplier has submitted updated documents with revised specifications. The comparison of
specifications of Duloxetine Pellets of M/s. Vision Pharma (as given in COA) and USP
monograph is as follows:
USP Limits (USP 39/NF 34
Tests Vision specifications
volume 2, 2016)
N/A
White to off white colored,
Physical appearance
spherical, enteric coated pellets
Identification
Retention time of principal peak
Retention time of the major
obtained in sample solution
peak of the sample solution
matches to that of standard
By HPLC corresponds to that of the
solution as obtained in assay.
standard solution as obtained in
the assay.
Sugar Test Negative N/A
Water Content (By
NMT 3.0% N/A
KF)
NLT 90% pass through mesh 16
Pellet size N/A
and NLT 90% retain on mesh 20.
No individual unit releases

Dissolution in Acid NMT 10% release in acid
more than 10% of the labeled
stage medium medium after 2 hours
amount of duloxetine in 2 h
Dissolution in
NLT 75% (Q) of the labeled
phosphate buffer
Q > 75% for 1 hour amount of duloxetine is
stage (pH=6.8)
dissolved in 60 min.
medium
Napthalen-1-ol NMT 0.2% Napthalen-1-ol NMT 0.2%
Related substances
Total impurities NMT 0.4% Total impurities NMT 0.4%.
90%-110% Assay by HPLC NLT 90.0% and

Assay Duloxetine w/w as Duloxetine NMT 110.0% of the labeled
HCl amount of duloxetine
Decision: Registration Board delierated the matter and considered the Duloxetine enteric
coated pellets of M/s. Vision Pharma of USP grade. Moreover, Registration Board
directed Evaluation cell to present all the deferred cases of Duloxetine Enteric coated
pellets of M/s. Vision Pharma in next Board meeting.
443. Name and address of manufacturer / M/s Sante (Pvt) limited Pharmaceuticals, 245/2-Z,
Applicant Block 6, PECHS, Karachi
Brand Name +Dosage Form + Strength Ilashes Ophthalmic Solution 0.03%
Diary No. Date of R& I & fee Dy.No. , 18-4-2016, Rs.50,000/- (Duplicate)
Bimatoprost…………0.3 mg
Pharmacological Group Prostaglandin Analog
Type of Form Form-5
Finished product Specification Manufacturer‘s specifications
Pack size & Demanded Price 1‘s; As Per SRO
Approval status of product in Reference Bimatoprost of Apotex Inc (USFDA)
Me-too status Lumigan eye drops of Barret Hodgson (Reg #
033177)
GMP status Last inspection report dated 20-11-17 confirms
good compliance to GMP
Previous remarks of the Evaluator. Section of sterile ophthalmic drops present.
Previous decision(s) Deferred in 277th meeting for confirmation of Diary
number date of submission of dossier from R & I
section.
Evaluation by PEC ● The firm has submitted Diary No. 10809 from R&I
section dated 19-06-2014.
● Photocopy of fee challan Rs. 50,000/- dated 20-05-
2014 has been provided.
Decision: Approved with innovator’s specifications. Reference will be sent to Budget &
Accounts Division for verification of challan and Board authorized its Chairman for the
issuance of registration letter.
444. Name and address of manufacturer / M/s. Dyson Research Labs 28 km, Ferozpur road,
Applicant Lahore
Brand Name +Dosage Form + Strength Glipmet tablet 50/500 mg
Diary No. Date of R& I & fee Dy. NO..., 4-08-2014, Duplicate Dossier
Sitagliptin as phosphate monohydrate……50 mg
Metformin HCl……………..…500 mg
Pharmacological Group Antidiabetic (dipeptidyl peptidase-4 inhibitor)
Type of Form Form 5
Finished product Specification Manufacturer
Pack size & Demanded Price 30‘s; As per DRAP policy
Approval status of product in Reference Janumet tablet of Merck Sharp Dohme (USFDA)
Me-too status S-Gliptin Plus tablet of Barret hodgson (Reg # 076344)
GMP status Last inspection conducted on 1-8-2017 with satisfactory
GMP compliance.‖
Previous remarks of the Evaluator.
Previous decision(s) Registration Board in 277th meeting deferred the case for
confirmation of diary numbers from R & I section &
evidence of submission of fee.
Evaluation by PEC ● The firm has provided Dy No: 937 dated 06-02-2013
from R & I section.
● The firm submitted photocopy of Fee challan Rs.
20,000/- dated 06-02-2013.
445. Name and address of manufacturer / M/s. Dyson Research Labs 28 km, Ferozpur road
Applicant Lahore
Brand Name +Dosage Form + Strength Dyglip tablet 50 mg
Diary No. Date of R& I & fee Dy. NO. .., 4-08-2014, Duplicate
Sitagliptin as phosphate monohydrate………50 mg
Type of Form Form 5
Approval status of product in Reference Januvia tablet 50mg of MSD (USFDA)
Me-too status Sita 50mg Tablet of Pharmevo (Reg # 055475)
GMP status Last inspection conducted on 1-8-2017 with
satisfactory GMP compliance.‖
Previous remarks of the Evaluator. Product is present in USP
Evaluation by PEC ● The firm has provided Dy No: 934 dated 06-02-2013.
20,000/- dated 06-02-2013.
Applicant Lahore
Brand Name +Dosage Form + Strength Dyglip tablet 100 mg
Diary No. Date of R& I & fee Dy. No..., 4-08-2014, Duplicate
Sitagliptin as phosphate monohydrate……100 mg
Type of Form Form 5
Approval status of product in Reference Januvia tablet 100mg of MSD (USFDA)
Me-too status Sita 100mg Tablet of Pharmevo (Reg # 055475)
Previous remarks of the Evaluator. Product is present in USP
20,000/- dated 06-02-2013.
447. Name and address of manufacturer / M/s. Dyson Research Labs 28 km, Ferozpur road Lahore
Applicant
Brand Name +Dosage Form + Strength Triglip tablet 50 mg
Diary No. Date of R& I & fee Dy. NO. .., 4-08-2014, Duplicate Dossier
Vildagliptin……………………50 mg
Type of Form Form 5
Approval status of product in Reference Vildagliptin 50 mg (TGA Approved)
Me-too status Galvus by Novartis
GMP status Last inspection conducted on 1-8-2017 with satisfactory
GMP compliance.‖
confirmation of diary numbers from R & I section.
20,000/- dated 06-02-2013.
Applicant Lahore
Brand Name +Dosage Form + Strength Vildamet tablet 50/850 mg
Vildagliptin……………………50mg
Metformin Hydrochloride……..850mg
Pharmacological Group Antidiabetic (dipeptidyl peptidase-4 inhibitor and
biguanide)
Type of Form Form 5
Approval status of product in Reference Galvumet 50/850 by Novartis (TGA Approved)
Me-too status Galvusmet by Novartis (Reg # 066106)
Previous remarks of the Evaluator. • Shelf life of the innovator as approved by
TGA is 18 months for PA/Al/PVC/Al -polyamide-
aluminum foil-polyvinylchloride/aluminum foil,
while the shelf life approved by MHRA is
PA/Alu/PVC/Alu- 2 years PCTFE/PVC/Alu- 18
months
Previous decision(s) Registration Board in 277th meeting deferred the
case for confirmation of diary numbers from R & I
section.
● Photocopy of Fee challan Rs. 20,000/- dated 06-02-
2013.
Decision: Approved with Innovator’s specifications with a shelf life of 18 months.
Reference will be sent to Budget & Accounts Division for verification of challan and Board
authorized its Chairman for the issuance of registration letter.
Applicant Lahore
Brand Name +Dosage Form + Strength Vildamet tablet 50/1000 mg
Vildagliptin……………………50mg
Metformin Hydrochloride……..1000 mg
Pharmacological Group Antidiabetic (dipeptidyl peptidase-4 inhibitor and
biguanide)
Type of Form Form 5
Pack size & Demanded Price 30‘s, As per DRAP policy
Approval status of product in Reference GALVUMET 50/1000 by Novartis (TGA
Me-too status Galvus met by Novartis (Reg # 066107)s
Previous remarks of the Evaluator. • Shelf life of the innovator as approved by
TGA is 18 months for PA/Al/PVC/Al -polyamide-
aluminum foil-polyvinylchloride/aluminum foil,
while the shelf life approved by MHRA is
PA/Alu/PVC/Alu- 2 years PCTFE/PVC/Alu- 18
months
Previous decision(s) Registration Board in 277th meeting deferred the
case for confirmation of diary numbers from R & I
section.
2013.
Decision: Approved with Innovator’s specifications with a shelf life of 18 months.
Reference will be sent to Budget & Accounts Division for verification of challan and Board
450. Name and address of manufacturer / M/s. Dyson Research Labs 28 km, Ferozpur road Lahore
Applicant
Brand Name +Dosage Form + Strength Glipmet tablet 50/1000 mg
Sitagliptin as phosphate monohydrate………50 mg
Metformin HCl……………………1000 mg
Type of Form Form 5
Approval status of product in Reference Janumet by merck (USFDA),
Me-too status Tagipmet by Highnoon
confirmation of diary numbers from R & I section.
2013.
451. Name and address of manufacturer / M/s Benson Pharmaceuticals Islamabad contract
Applicant manufacturing by M/s WnsFeild Pharmaceuticals,
Hattar.
Brand Name +Dosage Form + Strength Allerkast 4mg Sachet
Montelukast as sodium……....4mg
Diary No. Date of R& I & fee Dy.No. 1116, 24-02-2015, Rs.50,000/-
Pharmacological Group Bronchodilators, Anti-Asthmatic
Type of Form Form-5
Pack size & Demanded Price AS per SRO
Approval status of product in Reference Singulair sachet of Merck (USFDA)
Me-too status Aerokast of Barrett Hodgson
GMP status Last GMP Inspection of WnsFeild Pharmaceuticals
conducted on 7-4-2017 with conclusive remarks of
compliance of cGMP.
Previous decision(s) Deferred in 272nd meeting for the confirmation of
approved sections and number of already approved
products under the contract manufacturing.
Evaluation by PEC The firm M/s Benson Pharma has 5 approved sections:
Tablet, Capsule, Tablet (Cephalosporin), Capsule
(Cephalosporin), Dry Powder suspension
(cephalosporin).
M/s Winsfield Pharma has eleven (11) approved
sections.
The firm claimed that they have 13 molecules/21
products registered for contract manufacturing.
Decision: Approved
452. Name and address of manufacturer / M/s. Medicraft Pharmaceuticals, 126-B, industrial estate,
Brand Name +Dosage Form + Strength Neostamed 0.5 mg/ml Injection
Composition Each Ampoule Contains:-
Neostigmine methylsulfate equal to Neostigmine
……..0.5 mg
Pharmacological Group Anti-cholinesterase
Type of Form Form-5
Pack size & Demanded Price 1‘s ampoule / As per PRC
Approval status of product in Reference Neostigmine Methylsulfate of Fresenius Kabi (USFDA)
Me-too status Stigen of Fassgen pharma (Reg # 056452)
GMP status Last GMP Inspection dated 27-7-2016
Previous remarks of the Evaluator. •Latest GMP inspection report (which should have been
conducted within the period of last one year) missing
Previous decision(s) ● Deferred in 274th meeting for latest GMP inspection
report conducted within past one year
Evaluation by PEC ● In the light of observation at the time of inspection
conducted on 30-01-2018, documents reviewed and
representatives of the firm commitment, the firm may
be considered to be operative in good level of cGMP
compliance.
Decision: Deferred for clarification of of applied composition since reference product contains
Neostigmine methylsulphate ……….0.5mg while the firm has applied Neostigmine….0.5mg.
Brand Name +Dosage Form + Strength Linezomed 100 mg / 5 ml Dry Suspension
Composition Each 5ml DS Contains:-
Linezolid …………. 100 mg
Pharmacological Group Antibacterial Agent Of Oxazolidinone Class
Type of Form Form-5
Finished product Specification As per innovator
Pack size & Demanded Price 1‘s X 60 ml /As per PRC
Approval status of product in Reference Zyvox By Pharmacia And Upjohn (USFDA)
Me-too status Nezocin Of Brookes Pharmaceutical
compliance.
Decision: Approved
Brand Name +Dosage Form + Strength Linezomed 600 mg Infusion
Composition Each 300 ml Contains:-
Linezolid.……… 600 mg
Pharmacological Group Antibacterial Agent Of Oxazolidinone Class
Type of Form Form-5
Pack size & Demanded Price 1‘s / As per PRC
Approval status of product in Reference Linezolid 2 mg/ml solution for infusion by M/s Pfizer
Regulatory Authorities. Limited, (MHRA)
Me-too status Zolrest Infusion 600mg/300ml by M/s Bosch
(Reg#055916)
compliance.
Decision: Registration Board approved the applied formulation with innovator’s specifications
in the light of decision taken in 271st meeting, stated as under:
decided as under;
i) All the Manufacturers of Linezolid Infusion shall follow the packaging instructions of
the innovator of the product i.e M/s Pfizer which has clearly mention the storage
precautions in its Product Information Leaflet (PIL). They will also make sure that the
solution is kept correctly in its box and foil wrapping in order to protect from light.”
Brand Name +Dosage Form + Strength Ketamed 500 mg/10 ml Injection
Composition Each Ampoule Contains:-
Ketamine HCl equal to Ketamine ……. 500 mg
Pharmacological Group General anesthetic
Type of Form Form-5
Pack size & Demanded Price 1‘s vial /As per PRC
Approval status of product in Reference MHRA approved Ketamine – Pfizer 50mg/ml
Me-too status Ketarol of Global
compliance.
Decision:Approved.
Brand Name +Dosage Form + Strength Water For Injection 10 ml
Diary No. Date of R& I & fee Dyn:104, 18-05-2016, Rs.20,000/-
Composition Each vial contains:-
Water for injection……..……….. 10 ml
Type of Form Form-5
Pack size & Demanded Price 10 ml; As Per SRO
Approval status of product in Reference Sterile water for injection by hospira (USFDA)
Me-too status Sterile water for injection of Healthtek ( Reg # 076482)
Previous remarks of the Evaluator. Last GMP inspection report not within one year
compliance.
Decision: Approved.
457. Name and address of manufacturer / M/s. Cunningham Pharmaceuticals (Pvt.) Ltd,
Applicant Plot#81,Sundar Industrial Estate, Raiwind Road, Lahore
Brand Name +Dosage Form + Strength CALEFEROL 5mg /ml INJECTION
Diary No. Date of R& I & fee Each ml contains:
Cholecalciferol………….5mg
Composition Dy. No.3754, 26/12/2016, Rs.20,000/-
Pharmacological Group Vitamin D analogue
Type of Form Form-5
Approval status of product in Reference --
Me-too status Calciferol 5mg/mL inj by Global Pharmaceuticals,
GMP status 17-03-2016, Grant of DML
Good Compliance.
Previous remarks of the Evaluator. 2nd proposed name Cola-Filon
3rd proposed name Locafil
Route of administration: I.M & Oral
International availability not confirmed
Previous decision(s) ● Deferred in 265th meeting of Registration Board for
evidence of approval by reference regulatory
authorities.
● Deferred in 274th meeting for submission of latest
inspection report conducted within one year by DRAP.
Evaluation by PEC Following reference for applied formulation has been
verified:
● ―VITAMINE D3 BON 200 000 U.I./1 ml, solution
injectable approved by ANSM of France‖
● Panel inspection conducted on 31-01-2018, it was
concluded that the firm was operating under good
compliance of cGMP on the day of inspection.
Decision: Approved
458. Name and address of manufacturer / M/s. Cunningham Pharmaceuticals (Pvt) Ltd.Plot No.81,
Applicant Sunder Industrial Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength Azosit 250mg Tablet
Diary No. Date of R& I & fee Each film coated tablet contains:
Azithromycin (as dihydrate)…250mg
Composition Diary No:3386, 14/04/2017, Rs: 20,000/-
Pharmacological Group Macrolide Antibiotic
Type of Form Form 5
Pack size & Demanded Price 6‘s / As per SRO
Approval status of product in Reference Azithromycin 250 mg Film-Coated Tablets by M/s
Regulatory Authorities. TEVA UK Limited (MHRA approved)
Me-too status Dalemycin 250mg Tablet by M/s Oakdale Pharma
(Reg#079380)
GMP status 17-03-2016, Grant of new DML, Panel recommended
grant of DML.
Previous remarks of the Evaluator. ● Latest inspection report not submitted by the firm.
This was conveyed to the firm and firm replied:
‗Cunningham Pharmaceuticals (Pvt) Ltd. Is a newly
developed facility, we just got manufacturing license
and now we are in the process of registration of
products for new sections and we are not in
production stage. Inspection report for DML is
attached with dossier.‘
Previous decision(s) ● Deferred in 274th for last inspection report conducted
within one year.
Evaluation by PEC ● Panel inspection conducted on 31-01-2018, it was
Decision: Approved
Brand Name +Dosage Form + Strength Azosit 500mg Tablet
Diary No. Date of R& I & fee Each film coated tablet contains:
Type of Form Form 5
Approval status of product in Reference Azithromycin 500 mg Film-Coated Tablets by M/s
Regulatory Authorities. TEVA UK Limited (MHRA approved)
Me-too status Plivazith 500mg Tablet by M/s Pliva Balochistan
(Reg#081027)
GMP status 17-03-2016
Grant of new DML
Panel recommended grant of DML.
developed facility, we just got manufacturing
licence and now we are in the process of registration
of products for new sections and we are not in
within one year.
Decision: Approved
Brand Name +Dosage Form + Strength Ferritose 50mg/ml Injection
Diary No. Date of R& I & fee Each ml contains:
Iron as ferric carboxymaltose………50mg
Pharmacological Group Haematinic
Type of Form Form 5
Pack size & Demanded Price 1‘s x 10ml / As per SRO
Approval status of product in Reference Injectafer 750 mg iron / 15 mL single-use vial by M/s
Regulatory Authorities. Luitpold Pharms Inc (USFDA Approved)
Me-too status Ferinject 50mg/ml Injectable Vial (10ml) by M/s R.G
Pharmaceutica (Reg#072548)
Grant of new DML
within one year.
● Firm has applied for a vial but does not have the
relevant section.
● Evidence of 10 ml pack size in Reference
Regulatory Authorities was not confirmed but me-
too has been confirmed in 10ml vial.
Decision: Deferred for evidence of approval of required manufacturing facility for applied
formulation.
Brand Name +Dosage Form + Strength Aquaject Injection 5ml
Diary No. Date of R& I & fee Each glass ampoule contains:
Water For injection…5ml
Pharmacological Group WFI
Type of Form Form 5
Pack size & Demanded Price 100‘s x 5ml / As per SRO
Approval status of product in Reference Sterile water for injection by M/s Pfizer Limited,
Regulatory Authorities. MHRA approved.
Me-too status Aqua R ampoule by M/s Regal Pharmaceuticals
(Reg#082010)
Grant of new DML
within one year.
● The firm has provided liquid ampoule section
(General).
Decision: Approved
Brand Name +Dosage Form + Strength Lidopole Injection 1% w/v IM
Diary No. Date of R& I & fee Each 2ml Ampoule contains:
Lidocaine hydrochloride…20 mg (w/v)
Pharmacological Group Local anesthetics
Type of Form Form 5
Pack size & Demanded Price 2ml x 50‘s / As per SRO
Approval status of product in Reference 1% w/v Lidocaine Injection BP by M/sB. Braun
Regulatory Authorities. Melsungen AG, MHRA Approved.
Me-too status Epocain 1% Injection 2ml by M/s Epoch (Reg#047129)
Grant of new DML
within one year.
Decision: Approved
463. Name and address of manufacturer / M/s Wimits Pharmaceuticals, Sundar Industrial Estate,
Applicant Raiwind Road, Lahore
Brand Name +Dosage Form + Strength Refit Capsules
Diary No. Date of R& I & fee Dy. No. 2744`/(R&I)Dated 30.12.2014, Rs. 20,000/-

Orlistat 50% w/w pellets eq. to Orlistat………. 120 mg
Source of pellets: Spansules formulations, India
Pharmacological Group Gastrointestinal Lipase Inhibitor
Type of Form Form-5
Pack size & Demanded Price 10‘s; AS PER SRO
Me-too status Orlovit by CCL Pharma
GMP status The firm is GMP compliant as per inspection conducted
on 10-10-2016.
Previous remarks of the Evaluator. Differential fee for import of pellets shall be submitted.
Previous decision(s) ● Deferred in 273rd meeting for submission of
differential fee of Rs. 80,000 for import of pellets.
Evaluation by PEC ● The firm has changed the source of pellets from
Spansules Formulations, India to Vision
Pharmaceuticals.
● The firm has submitted COA of pellets, valid GMP of
manufacturer (inspection conducted on 26-01-2018)
and stability studies of 3 batches.
● The firm was granted GMP certificate based on
inspection conducted on 03-11-2017.
Decision: Approved
Brand Name +Dosage Form + Strength Itral capsule
Diary No. Date of R& I & fee Rs. 20,000/-
Dy. No. 2696/(R&I)Dated 30.12.2014
Itraconazole …………… 100 mg
Pharmacological Group Triazole Antifungal
Type of Form Form-5
Me-too status Terizole100mg Capsules M/s Panacea Pharmaceuticals,
Islamabad (Reg.#081423)
GMP status The firm is GMP compliant as per inspection conducted on
10-10-2016.
Previous remarks of the Evaluator. Source of pellets, along with stability studies data, GMP
certificate of supplier and differential fee in case of import
of pellets shall be submitted.
Previous decision(s) ● Deferred in 273rd meeting for submission of source of
pellets, along with stability studies data, GMP
certificate of supplier and differential fee in case of
import of pellets.
Evaluation by PEC ● Source of Itraconazole IR pellets 22%: M/s Vision
Pharma
● The firm has submitted COA of pellets, Valid GMP of
manufacturer (inspection conducted on 26-01-2018)
and stability studies of 3 batches.
Brand Name +Dosage Form + Strength Actopil Injection
Diary No. Date of R& I & fee Dy. No. 2748/(R&I)Dated 30.12.2014, Rs. 20,000/-
Composition Each 5ml contains

Piracetam ……………. 1 gm
Pharmacological Group Neuronal metabolic modulator, Psychostimulant
Type of Form Form-5
Me-too status Neurotam Injection M/s Medisure Karachi.
(Reg.#073480)
on 10-10-2016.
Previous remarks of the Evaluator. Evidence of approval by reference regulatory authority
shall be submitted.
Previous decision(s) ● Deferred in 273rd meeting for evidence of approval of
applied formulation in reference regulatory
authorities/agencies which were declared/approved by
the Registration Board in its 249th meeting.
Evaluation by PEC ● The firm has submitted approval status in Italy
(Nootropil 1 g injection of UCB Pharma S.P.A , Italy).
Brand Name +Dosage Form + Strength Sulo Capsules
Diary No. Date of R& I & fee Dy. No. 2734/(R&I)Dated 30.12.2014; Rs. 20,000/-
Composition Each capsule Contains:
Tamsulosin hydrochloride…...0.4mg
Source of pellets;
M/s Lee Pharma, India
Pharmacological Group Antagonist of alpha1A
Type of Form Form-5
Pack size & Demanded Price 10‘s; as per SRO
Me-too status Uripro 0.4mg Capsule M/s Getz Pharma
(Reg.#081040)
on 10-10-2016.
Previous remarks of the Evaluator. Differential fee for import of pellets shall be submitted.
Previous decision(s) ● Deferred in 273rd meeting for submission of
differential fee of Rs. 80,000/- for import of pellets.
Evaluation by PEC ● The firm has changed the source of pellets from M/s
Lee Pharma to M/s Vision Pharma.
● The firm has submitted COA of pellets, GMP of
manufacturer and stability studies of 3 batches.
Decision: Approved
467. Name and address of manufacturer / M/s Welmark Pharmaceuticals, Hattar
Applicant
Brand Name +Dosage Form + Strength Esocon 20mg tablet
Esomeprazole…..20mg
Diary No. Date of R& I & fee Dy. No.1200; 11-1-2010; Rs.8,000/- (07-10-2010);
Rs.12,000/- (31-10-2014)
Type of Form Form-5
Pack size & Demanded Price 2x7‘s: As per SRO
Approval status of product in Reference Nexium 20mg tablet of MHRA approved
Me-too status Esomperazole 20mg by Webros Pharma (Reg No
056835)
GMP status Last inspection report.12-7-2017, overall cGMP was
satisfactory as per Drap Guidelines.
Previous remarks of the Evaluator. The firm has applied plain tablet while Internationally
the product was in enteric coating.
Previous decision(s) Deferred in 273rd meeting for evidence of approval in
reference regulatory authorities.
Evaluation by PEC ● The firm has submitted revised Form-5 with
following label claim
● Each Enteric coated tablet contains:
Esomeprazole (as magnesium trihydrate)……20mg.
Decision: Deferred for submission of fee for revision of applied formulation.
468. Name and address of manufacturer / M/s Valor Pharmaceuticals (Pvt.) Ltd.,124/A Kahuta
Applicant Road, Industrial Triangle Zone, Islamabad.
Brand Name +Dosage Form + Strength Rivar 10mg Tablets
Rivaroxaban……….10mg
Type of Form Form-5
Finished product Specification As per innovator‘s
Pack size & Demanded Price 10‘s; Not demanded
Approval status of product in Reference Xarelto (USFDA approved)
Me-too status Xarelto of M/s Bayer Healthcare.
GMP status
Previous remarks of the Evaluator. ➢ Approved in USFDA with boxed warning: (a)
premature discontinuation of rivaroxaban increases
the risk of thrombotic events, and (b)
spinal/epidural hematoma.
➢ Shortcomings:
● Latest GMP inspection report conducted within
the period of last one year.
● Scientific justification regarding overage of API.
Previous decision(s) Deferred in 274th meeting for submission of
last one year.
● Scientific justification for addition of overage in
master formulation.
Evaluation by PEC ● Considering the findings of inspection on 15-09-2017,
the panel unanimously recommended for the grant of
GMP certificate.
● The firm has submitted revised master formulation
without overage.
Decision: Approved.
Brand Name +Dosage Form + Strength Piclone 3mg Tablets
Eszopiclone…………3mg
Pharmacological Group Hypnotic/sedative
Type of Form Form-5
Approval status of product in Reference Lunesta (USFDA approved)
Me-too status Clonexa of M/s Atco pharma.
GMP status
Previous remarks of the Evaluator. ➢ Shortcomings:
● Latest GMP inspection report conducted within the
period of last one year.
● Revised master formula; as the quantity of eszopiclone
mentioned in master formula is ―1.02 mg‖ whereas the
applied strength is 3mg eszopiclone per tablet.
● latest GMP inspection report conducted within
last one year
● Revised master formula depicting correct
quantity of API.

GMP certificate.
with correct quantity of API.
Decision: Deferred for submission of fee for revision of master formulation.
Applicant Road,Industrial Triangle Zone, Islamabad.
Brand Name +Dosage Form + Strength Lazine 500mg ER Tablets
Ranolazine…………500mg
Pharmacological Group Anti-angina
Type of Form Form-5
Approval status of product in Reference Ranexa (USFDA approved)
Me-too status Ranzol 500mg XR tablet of M/s Maple pharmaceuticals.
GMP status
Previous remarks of the Evaluator. Last inspection report conducted within last one year.
Previous decision(s) Deferred in 274th meeting for submission of latest GMP
inspection report conducted within last one year

GMP certificate.
Decision: Approved
Brand Name +Dosage Form + Strength Nicline 1mg Tablets
Varenicline…………..1mg
Pharmacological Group Nicotinic acetylcholine receptor partial agonist/smoking
cessation aid
Type of Form Form-5
Approval status of product in Reference Chantix (USFDA approved)
Me-too status Chantix 1mg tablets of M/s Pfizer.
GMP status
Previous remarks of the Evaluator. ● Latest GMP inspection report conducted within the
period of last one year.
● Revised master formula depicting correct quantity of
API.
last one year
● Revised master formula depicting correct
quantity of API.

GMP certificate.
with correct quantity of API.
Decision: Deferred for submission of fee for revision of master formulation
Brand Name +Dosage Form + Strength Urinic 40mg tablet
Febuxostat……….40mg
Type of Form Form-5
Approval status of product in Reference Uloric (USFDA approved)
Me-too status Zurig of M/s Getz pharma.
GMP status
Previous remarks of the Evaluator. ● Last inspection report conducted within last one year.
● Scientific justification regarding overage of API.
● Evidence of approval status of product as uncoated
tablet in reference regulatory authorities
last one year
● Scientific justification for addition of overage in
master formulation.
● Evidence of approval status of product as
uncoated tablets in reference regulatory
authorities.

GMP certificate.
without overage.
● The firm has submitted revised composition with film
coating solution for applied formulation.
Brand Name +Dosage Form + Strength Valogab 75mg capsules
Pregabalin………………..….75mg
Pharmacological Group GABA analogue
Type of Form Form-5
Me-too status Gabica 75mg capsules of M/s Getz Pharma.
GMP status
Previous remarks of the Evaluator. ● Latest GMP inspection report conducted within
last one year.
● Outline of method of manufacture.
last one year
GMP certificate.
● The firm has submitted outline of method of
manufacture.
Decision: Approved.
Brand Name +Dosage Form + Strength Valogab 150mg capsules
Pregabalin………………..….150mg
Type of Form Form-5
Me-too status Gabica 150mg capsules of M/s Getz Pharma.
GMP status
last one year.
● Latest GMP inspection report conducted within last
one year
● Outline of method of manufacture
GMP certificate.
manufacture.
Decision: Approved.
Brand Name +Dosage Form + Strength Valaflu 75mg capsules
Oseltamivir (as phosphate)……..….75mg
Pharmacological Group Antiviral
Type of Form Form-5
Me-too status Tamiflu 75mg capsules of M/s Roche
GMP status
last one year.
● Revised master formula; as the quantity of
oseltamivir phosphate stated in master formula is
40.20mg
● latest GMP inspection report conducted within last
one year
● revised master formula depicting correct quantity of
API
● outline of method of manufacture
GMP certificate.
● The firm has submitted revised master formula with
correct quantity of API.
manufacture.
476. Name and address of manufacturer / M/s Merck (Pvt) limited, 7, Jail Road, Quetta.
Applicant
Brand Name +Dosage Form + Strength Vitabone injection
Cholecalciferol (Vit-D3)…………5mg (200,000 IU)
Type of Form Form-5
Pack size & Demanded Price 1‘s; Rs.139/-
Approval status of product in Reference ANSM approved
Me-too status Oral D-3 of M/s Schazoo Pharma
which concludes good level of GMP compliance.
Previous decision(s) ● Deferred in 273rd meeting due to paucity of time.
● Registration Board in 277th meeting referred the case
to QA & LT Division to conduct GMP inspection of
Firm on priority.
Evaluation by PEC ●
GMP inspection conducted on 29-01-2018, the
current GMP was rated as good.
● The firm has submitted document from licensing
division for approved change of name/title of
company from M/s Merck (Private) limited, 7 Jail
Road, Quetta, Pakistan to M/s Martin Dow Marker
Ltd, 7, Jail Road, Quetta, Pakistan.
Decision: Deferred for submission of revised Form-5 and fee for change of title/name of thee
firm.
477. Name and address of manufacturer / M/s Pakrisen Pharmaceuticals, Hattar contract
Applicant manufacturing by M/s Caraway Pharmaceuticals Rawat.
Brand Name +Dosage Form + Strength Pakxime 200mg capsule
Cefixime (as trihydrate)………….200 mg
Pharmacological Group Cephalosporin, antibiotic
Type of Form Form-5
Finished product Specification JP
Approval status of product in Reference CEFIXIMA NORMON 200 mg CAPSULAS by M/s
Regulatory Authorities. Laboratorios Normon, S.A., Spain approved
Me-too status Vfix Capsules 200 mg of M/s Focus &Rulz
Pharmaceuticals (Reg.# 066641)
GMP status Last inspection of M/s Caraway Pharmaceuticals
conducted on 9-12-2016 and report concludes that firm
is found to be operating at good level of GMP
compliance.
Previous remarks of the Evaluator. ●
Previous decision(s) ● Deferred in 273rd meeting due to paucity of time.
Evaluation by PEC ● Copy of inspection conducted on 19-12-2017, the
level of overall GMP compliance of the firm M/s
Caraway Pharma is Good as of today.
Decision: Approved.
478. Name and address of manufacturer / M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar
Applicant Industrial Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength Qutin Tablet 400mg
Diary No. Date of R& I & fee Diary No: 23963 , 13-12-2017 , Rs: 20,000/-
Composition Each film-coated Tablet contains:
Quetiapine (as fumarate)…400mg
Type of Form Form-5
Pack size & Demanded Price 10‘s,14‘s, 20‘s, 30‘s/As per SRO
Approval status of product in Reference SEROQUEL XR film coated tablets 400mg by M/s
Regulatory Authorities. Astrazeneca (USFDA Approved)
Me-too status Qutirate XR Tablets of Shrooq Pharma (Reg # 067843)
Grant of new DML,
Panel recommends grant of new DML.
Previous decision(s) Deferred in 278th meeting for evidence of applied
formulation/drug already approved by DRAP (generic /
me-too status) alongwith registration number, brand
name and name of firm.
Evaluation by PEC ● The firm has submitted revised Form-5 alongwith fee
challan of Rs. 20,000/- (Deposit slip No. 0725168) dated
13-03-2018.
● Each extended release tablet contains:
● Quetiapine fumarate eq. to Quetiapine….400mg
● The new proposed brand name is ―Qutin XR Tablet
400mg.‖
Decision: Approved.
479. Name and address of manufacturer / M/s Pharmasol (Pvt) Ltd.Plot No. 549, Sundar Industrial
Applicant Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength Cerecolin Injection 250mg/2ml
Diary No. Date of R& I & fee Diary No: 24063, 13-12-2017 , Rs: 20,000/-
Citicoline…250mg
Pharmacological Group Psychostimulants, Agents Used For ADHD And
Nootropics (Other psychostimulants and nootropics)
Type of Form Form-5
Finished product Specification Innovator‘s specifications
Pack size & Demanded Price 2mlx1‘s , 2mlx10‘s /As per SRO
Approval status of product in Reference CITICOLINE PANPHARMA 250 mg / 2 ml solution
Regulatory Authorities. for injection (IM, IV) ampoule by M/s PANPHARMA
(ANSM, France Approved)
Me-too status Cerebolin Injection 250mg/2ml by M/s Zam Zam
(Reg#021969)
Grant of new DML,
Previous remarks of the Evaluator. ● In ANSM France:
Approved with API Citicoline (as sodium)…250mg
● Firm initially applied for Citicoline…250mg. When
communicated with shortcoming, firm replied that they
mistakenly wrote Citicoline instead of citicoline (as
sodium). Firm has submitted revised form-5 and master
formulation.
Previous decision(s) Deferred in 278th meeting for submission of fee for
revision of formulation
Evaluation by PEC ● The firm has submitted Rs. 20,000/- (Deposit slip No.
0725163) dated 13-03-2018 for revision of applied
formulation. The description of applied formulation is
now as:
Each 2ml ampoule contains:
● Citicoline (as sodium)…….…250mg
Decision: Approved.
480. Name and address of manufacturer / M/s Pharmasol (Pvt) Ltd.Plot No. 549, Sundar Industrial
Applicant Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength Cerecolin Injection 500mg/4ml
Composition Each 4ml ampule contains:
Citicoline…500mg
Pharmacological Group Psychostimulants, Agents Used For ADHD And
Nootropics (Other psychostimulants and nootropics)
Type of Form Form-5
Pack size & Demanded Price 4mlx1‘s, 4mlx10‘s/As per SRO
Approval status of product in Reference CITICOLINE PANPHARMA 500 mg/ 4ml, solution
Regulatory Authorities. injectable (IM,IV) ampoule by M/s PANPHARMA
(ANSM, France Approved)
Me-too status SOMAZINA INJECTION 500 by Alina pharma (Reg.
No. 016975),
Grant of new DML,
Previous remarks of the Evaluator. ● In ANSM France:
Approved with API Citicoline (as sodium)…500mg
● Firm initially applied for Citicoline…500mg. When
communicated with shortcoming, firm replied that they
mistakenly wrote Citicoline instead of citicoline (as
sodium). Firm has submitted revised form-5 and master
formulation.
now as:
Each 4ml ampoule contains:
● Citicoline (as sodium)…….…500mg
Decision: Approved
Brand Name +Dosage Form + Strength Cartilex Tablet 500/400mg
Glucosamine sulphate…500mg
Chondroitin sulphate…400mg
Pharmacological Group Other antiinflammatory and antirheumatic agents, non-
steroids
Type of Form Form-5
Pack size & Demanded Price 20‘s /As per SRO
Approval status of product in Reference Glucosamine 500mg + Chondroitin 400mg Tablet by
Regulatory Authorities. M/s Universal Nutrition & Beauty Care Pty Ltd (TGA
Approved)
Me-too status Gevolox CH Tablets by M/s Hilton (Reg#039688)
Grant of new DML,
Previous remarks of the Evaluator. ● Firm has applied as film-coated tablet but reference in
TGA provides evidence of uncoated tablet.
● When communicated with shortcoming, firm replied that
they mistakenly added coating material in master
formulation and have now removed it from said
document now. Firm has submitted revised form-5 and
master formulation.
now as:
Each uncoated tablet contains:
● Glucosamine sulphate………...500mg
Chondroitin sulphate…………400mg
Decision: Approved
Brand Name +Dosage Form + Strength Caldron Tablet 70mg/70mcg (2800IU)
Alendronic acid as alendronate sodium
trihydrate………...70mg
Cholecalciferol…70mcg(2800IU)
Pharmacological Group Drugs affecting bone structure and mineralization
(Bisphosphonates, combinations)
Type of Form Form-5
Finished product Specification Innovator's specifications
Pack size & Demanded Price 4‘s ,7‘s /As per SRO
Approval status of product in Reference Apo-Alendronate Plus D3 Tablets by M/s Apotex Pty
Regulatory Authorities. Ltd (TGA Approved)
Alendronic Acid/Colecalciferol 70 mg/2800 IU tablets
by M/s Creo Pharma Limited (MHRA Approved)
Me-too status Drate Plus D Tablets70mg/70mcg by M/s S.J&G Fzul
Ellahie (Reg#047288)
Grant of new DML,
Previous remarks of the Evaluator. ● Confirmed as plain tablet from TGA & MHRA while
firm has applied as film-coated tablet.
they mistakenly added coating material in master
formulation and have now removed it from said
document now. Firm has submitted revised form-5 and
master formulation.
now as:
Each uncoated tablet contains:
Alendronic acid as alendronate sodium
trihydrate………….70mg
Cholecalciferol….…70mcg (2800IU)
Decision: Approved
Brand Name +Dosage Form + Strength Micona Gel 2%w/w
Composition Each gram contain:
Miconazole nitrate…20mg (2%w/w)
Type of Form Form-5
Finished product Specification BP (as oromucosal gel)
Pack size & Demanded Price 20gm /As per SRO
Approval status of product in Reference Daktarin 2% w/w oral gel by M/s J anssen-Cilag Limited
Me-too status Mogel 20mg/g Oral Gel by M/s Sigma Pharma (Reg no.
079910)
Grant of new DML,
Previous remarks of the Evaluator. ● Approval status of product in Reference Regulatory
Authorities not confirmed.
● In MHRA formulation is approved as oral gel which
contains Miconazole base while firm has applied as
Miconazole Nitrate.
they mistakenly wrote Miconazole nitrate instead of
miconazole base. Firm has submitted revised form-5 and
master formulation.
Evaluation by PEC ● The firm has submitted original fee challan of Rs.
20,000/- (Deposit slip No. 0725167) dated 13-03-2018
for revision of applied formulation. The correct
description of applied formulation is now as:
Each gram contain:
Miconazole …………20mg (2%w/w)
The new proposed brand name is ―Micona Oral Gel
2%w/w‖.
Decision: Approved.
Brand Name +Dosage Form + Strength Spasex Tablet 80mg/80mg
Phloroglucinol dihydrate…………….80mg
Trimethylphloroglucinol…………….80mg
Pharmacological Group Anti-spasmodic
Type of Form Form-5
Finished product Specification Innovator's specifications
Pack size & Demanded Price 30‘s/ As per SRO
Approval status of product in Reference SPASFON, coated tablet by M/s Teva Health (ANSM
Regulatory Authorities. approved.)
Me-too status Anafortan Plus Tablet by M/s AGP Pharma
(Reg#024504)
Grant of new DML,
Previous remarks of the Evaluator. ● Approved as sugar coated tablet in ANSM, France.
Previous decision(s) Deferred in 278th meeting for clarification of
applied formulation since reference product is
available as sugar coated tablet whereas firm has
applied for film coated tablet
Evaluation by PEC The firm has submitted revised form-5 alongwith fee of
Rs. 20,000/- (Deposit slip No. 0744163) dated 21-03-
2018. The description of applied formulation is now as:
Each sugar coated Tablet contains:
Phloroglucinol dihydrate…………...80mg
Trimethylphloroglucinol……………80mg
Decision: Approved.
Brand Name +Dosage Form + Strength Tiplasol Injection 200mg
Teicoplanin powder for reconstitution …200mg
Pharmacological Group Glycopeptide Antibiotic
Type of Form Form-5
Approval status of product in Reference Targocid 200mg powder for solution for
Regulatory Authorities. injection/infusion or oral solution by M/s Aventis
Pharma Limited (or trading as Marion Merrell or
Aventis Pharma) (MHRA Approved)
Me-too status Targocid 200mg powder for injection by M/s Sanofi-
Aventis (Reg#019503)
Grant of new DML,
Previous decision(s) Deferred in 278th meeting for confirmation of
manufacturing in general filling area.
Evaluation by PEC The firm submitted that ―Teicoplanin lyophilized powder
is imported in ready to fill form and there is no need of
further processing.‖ Moreover, Registration Board in
275th meeting approved the product Tycon 200mg
Lyophilized injection for MTI Medical (Pvt.) Ltd,
Lahore.
Decision: Approved.
Brand Name +Dosage Form + Strength Tiplasol Injection 400mg
Teicoplanin powder for reconstitution …400mg
Pharmacological Group Glycopeptide Antibiotic
Type of Form Form-5
Pack size & Demanded Price 1‘s /
As per SRO
Approval status of product in Reference Targocid 400mg powder for solution for
Regulatory Authorities. injection/infusion or oral solution by M/s Aventis
Pharma Limited (MHRA Approved)
Me-too status Targocid 400mg powder for injection by M/s Sanofi-
Aventis (Reg#019504)
Grant of new DML,
Previous decision(s) Deferred in 278th meeting for confirmation of
manufacturing in general filling area.
Evaluation by PEC The firm submitted that ―Teicoplanin lyophilized powder
is imported in ready to fill form and there is no need of
further processing.‖ Moreover, Registration Board in
275th meeting approved the product Tycon 200mg
Lyophilized injection for MTI Medical (Pvt.) Ltd,
Lahore.
Decision: Approved
487. Name and address of manufacturer / M/s T.N Pharmaceuticals (Pvt) Ltd. Plot No.264-C,
Applicant Sunder Industrial Estate, Lahore
Brand Name +Dosage Form + Strength DETRODINE CAPSULE 4mg
Diary No. Date of R& I & fee Diary No:17095, 05/10/2017, Rs. 20,000
Composition Each capsule contains
Tolterodine Tartrate Sustained Release Pellets 2% eq.to
Tolterodine…4mg
Pharmacological Group Drug for urinary frequency and incontinence
Type of Form Form 5
Pack size & Demanded Price As per SRO/ 30‘s
Approval status of product in Reference Detrol LA (tolterodine tartrate extended release
Regulatory Authorities. capsules) by M/s Pharmacia And Upjohn (USFDA
Approved)
Me-too status DETRUSITOL SR 4mg capsule by M/s
Pfizer,(Reg#053805)
GMP status New DML granted
19/7/2017
Previous remarks of the Evaluator. ● Source of pellets:
M/s Zen Bio-Tech Pvt. Ltd,
PlotNo.195/4, PhaseII, I.D.A, Cherlapally, Medchal
District-500 051, Telangana, India.
● GMP certificate valid till 14-03-2018.
● GMP certificate does not state the name of
Tolterodine tartrate Extended Release Pellets
2%w/w.
● COA from supplier attached of of Tolterodine
tartrate Extended Release Pellets 2%w/w.
● Accelerated stability study and Real time stability
study report of 3 batches for pellets not submitted by
the firm.
● Fee challan for import of pellets not submitted by
the firm.
Previous decision(s) Deferred in 276th meeting for following submissions
i. Real time and accelerated stability study data of 3
batches of Tolterodine tartrate Extended Release
Pellets 2%w/w, conducted according to the
requirements of zone IV-A.
Differential fee of Rs.80,000/- for import of pellets
Evaluation by PEC The firm has submitted differential fee of Rs. 80,000/-
for imported pellets.
The firm has submitted Real time and accelerated
stability study data of 3 batches of Tolterodine tartrate
Extended Release Pellets 2%w/w, conducted according
to zone IV-A.
488. Name and address of manufacturer / M/s Medisave Pharmaceuticals, Plot No. 578-579,
Applicant Sundar Industrial Estate, Lahore
Brand Name +Dosage Form + Strength Rosun Tablets
Rosuvastatin (as calcium)….……10mg
Diary No. Date of R& I & fee Dy. No. 1097: 12-10-2015, 20,000/-: 09-10-2015
Pharmacological Group Antihyperlipidemic
Type of Form Form 5
Pack size & Demanded Price 14‘s: As per SRO
Approval status of product in Reference Crestor by Astrazaneca (MHRA Approved)
Me-too status Crestat Tablet by CCL Pharma (Reg # 042691)
GMP status
Previous remarks of the Evaluator. ● Latest GMP inspection report (which should have been
conducted within the period of last one year) is not
provided
Previous decision(s) ● Deferred in 273rd meeting for GMP inspection report
conducted within a period of last 1 year.
Evaluation by PEC The firm was granted GMP certificate based upon
inspection conducted on 11-12-2017 & 10-01-2018 and
recommended for renewal of DML.
Brand Name +Dosage Form + Strength Sitamin Tablets 50/1000mg
Composition Each Film Coated Tablet Contains:-
Sitagliptin as phosphate monohydrate…. ……50mg
Metformin hydrochloride………1000mg
Diary No. Date of R& I & fee Dy No. 1093: 12-10-2015, 20,000/-: 29-10-2015
Type of Form Form 5
Finished product Specification Firm has claimed in house specification
Approval status of product in Reference Janumet Tablet by MSD (USFDA Approved)
Me-too status Treviamet tablet of Getz (Reg # 055444)
GMP status
provided
Brand Name +Dosage Form + Strength Closun Tablet 75/75mg
Clopidogrel as hydrogen sulphate…. …75mg
Aspirin…………………..………..75mg
Diary No. Date of R& I & fee Dy No. 1095: 12-10-2015
PKR 20,000/-: 09-10-2015
Pharmacological Group Antiplatelet drug
Type of Form Form 5
Finished product Specification Firm has claimed in house specification
Approval status of product in Reference Apo-Clopidogrel/Aspirin by Apotex (TGA Approved)
Me-too status Ascard plus Tablet of Atco (Reg # 053363)
GMP status
Previous remarks of the Evaluator. The shelf life of product approved by TGA is 18 months
● Latest GMP inspection report (which should have been
conducted within the period of last one year) Is not
provided
Brand Name +Dosage Form + Strength Telsun Tablet 80/10mg
Composition Each tablet Contains:-
Telmisartan..……………………80mg
Amlodipine as besylate……….10mg
Type of Form Form 5
Approval status of product in Reference Twynsta by Boehringer (USFDA Approved)
Me-too status Am-Telsan tablet by Hilton (Reg # 067434)
GMP status
provided
Brand Name +Dosage Form + Strength Sitasun Tablet
Composition Each Film Coated Tablet Contains:-
Sitagliptin (as phosphate monohydrate) …. …100mg
Type of Form Form 5
Approval status of product in Reference Januvia by MSD (USFDA) Approved)
Me-too status A-Glip 100mg Tablet of Atco Lab (Reg # 053098)
GMP status
provided
Decision: Approved.
493. Name and address of manufacturer / CCL Pharmaceuticals (Pvt) Ltd 62-Industrial Estate,
Applicant Kot Lakhpat, Lahore
Brand Name +Dosage Form + Strength Pulmonol M Syrup 250mg/5ml
Composition Each 5ml contains:-
Carbocysteine….250mg
Diary No. Date of R& I & fee Dy No. 476, 29-01-2015; PKR 20,000/-, 28-01-2015
Pharmacological Group (mucolytic agent)
Type of Form Form 5
Finished product Specification As per Innovator
Pack size & Demanded Price 120mL
As per brand leader
Approval status of product in Reference Mucodyne syrup 250mg/5ml by Lexon (MHRA
Me-too status Rhinathiol syrup by Sanofi Aventis
satisfactory compliance to GMP
Previous remarks of the Evaluator. Firm has provided specifications of the innovator and
also the commitments to conduct validation of analytical
method. The submitted specifications (claimed to be of
innovator) contains tests for physical description, pH,
taste, odor, identification and assay while according to
MHRA and Irish assessment report the specification of
mucodyne should be as per pharmacopoeial monograph
for ‗Liquid preparations for oral use‘. The general
monograph for liquid preparations for oral use contains
tests for fill volume, uniformity of mass and uniformity
of dosage units as well.
Previous decision(s) Deferred in 269th meeting of Registration Board for
following submission:
● Change of brand name as the same is registered for
different active ingredient
● Latest GMP inspection report conducted within 1
year
● Clarification regarding the submitted innovator‘s
specification as they do not contain test of general
monograph for ―liquid preparations for oral use‖
including fill volume, uniformity of mass and
uniformity of dosage units as mentioned in the Irish
and MHRA assessment report.
● Deferred again in 274th meeting for further
deliberation for brand name of Pulmonol M for
applied formulation.
Evaluation by PEC ● Firm has stated that ―Pulmonol‖ is our registered
trademark having TM No. 085475 dated (18-02-
1985) in class 5 under section 33 of the Trade mark
ordinance 2001, and following products are already
registered in different composition and indicated for
wide range of indications of upper respiratory tract
disorders which are in line extension of Pulmonol
range:
i. Pulmonol syrup, Reg.# 00874
ii. Pulmonol Flu Syrup, Reg.# 068109
iii. Pulmonol DM Syrup, Reg.# 068110
iv. Pulmonol Junior Syrup, Reg.# 068111
v. Pulmonol CF Tablets, Reg.# 023982
● A similar case of change of brand name was
presented n 263rd meeting of Registration Board
wherein M/s. CCL Pharmaceuticals (Pvt) Ltd,
Lahore had requested for change of brand name of
their following product:
Names of Drug(s) with Reg. New

formulation No. proposed
names
Epinol CF Tablet 023982 Pulmonol
Each tablet contains: CF
Paracetamol……………500mg Tablet
Pseudoephedrine HCl….60mg
Chlorpheniramine Maleate..4mg
Registration Board deliberated that suffix of brand name

is different, thus the Board approved request of firm for
change of brand name from Epinol CF Tablet to
Pulmonol CF Tablet.
● The firm described that Pulmonol is their flagship
brand name which covers the product indicated in
disorder of upper respiratory tract especially cough
and cold in different combination. Furthermore as
per business strategy and marketing norms one
brand name can be used for minutely different
formulations of same category of products e.g
Hydryllin syrup, Hydryllin DM syrup, Hydryllin
Day syrup etc.
● Panel Inspection for grant of GMP certificate
conducted on 08-03-2017 & 31-03-2017, the firm
was found to be operating at a satisfactory level of
GMP compliance.
● Firm has submitted revised finished product
specifications including test of filled volume,
deliverable volume & Uniformity of dosage unit.
Decision: Registration Board deferred the case and advised PEC to present the case with
detailed composition of already registered Pulmonol brands. Moroever Registration Board
referred the case to QA & LT Division to conduct GMP inspection of Firm on priority.
494. Name and address of manufacturer / M/s Cibex (Pvt.) Ltd., F-405, S.I.T.E., Karachi.
Applicant
Brand Name +Dosage Form + Strength Klegg dry suspension
Composition Upon reconstitution each 5ml contains:
Clarithromycin (as taste masked ECP 27.5%)….250mg
➢ Source of pellets: Vision Pharmaceuticals
Pharmacological Group Macrolide antibiotics
Type of Form Form-5
Pack size & Demanded Price 60ml; As per PRC
Approval status of product in Reference Biaxin (USFDA approved)
Me-too status Maclacin of M/s Bosch
GMP status Certificate of cGMP based on evaluation conducted on
20-09-17 is provided.
Previous remarks of the Evaluator. ➢ Fee challan of Clarithromycin 500mg tablets is
attached instead of clarithromycin 250mg dry
suspension. However, an undertaking has also been
submitted that the challan number 0520918, dated
September 2, 2016 for Rs.20,000/- is intended to be
used for Klegg (Clarithromycin 250mg/5ml) dry
suspension only, and will not be used for any other
product.
Previous decision(s) ● Registration Board in 277th meeting deferred the case
for revision of Fee challan for applied formulation
from relevant Bank or else submit fresh fee of Rs.
20,000/-
Evaluation by PEC ● The firm has submitted photocopy of fee challan of Rs.
20,000/- (Deposit slip # 0229232) dated 17-01-2018
stating correct strength of clarithromycin 250 mg dry
suspension.
Decision: Deferred for confirmation from B&A Division for submitted fee for applied
formulation
Sr. Name and Brand Name Type of Form Approval Previous Evaluation
No address of (Proprietary Initial date, status in Decisions by PEC
manufacturer / name + Dosage diary Reference
Applicant Form + Fee including regulatory
Strength) differential agencies /
Composition fee authorities
Pharmacologic Demanded Me-too
al Group Price /Pack status/
Finished size GMP
product status
Specification
495. M/s. Jeans Levojaens Form-5 Evoxil The firm
Pharmaceuticals, 250mg Tablet 2027, 16-01- 250mg had initially Now the firm
Lahore Each film 2018, 20,000/- tablet of applied has
coated tablet 15-01-2018 Beacon Levofloxaci submitted
contains:- pharma n capsules revised
(Deposit slip
Levofloxacin as (MHRA) Form-5
No:0733978) 250mg
Hemihydrate Levocil stating tablet
…..250mg. 1× 10‘s; As tablet of which was dosage form
Fluoroquinolon per SRO CCL (Reg deferred in of applied
e # 023985) 250th product with
Inspection meeting. complete
conducted The Board dossier.
on 20-12- directed that
2017, The applicant
firm was shall either
operating revise their
satisfactory formulation
. Overall to tablet
hygienic dosage form,
condition if not
of the firm registered
was previously
satisfactory and if
, however manufacturin
they were g facility is
advised to approved by
continue CLB (new
improveme registration
nts in QC application
and with
production complete fee)
they .
agreed.
Decision: Approved with USP specification
496. M/s. Jeans Levojaens Form-5 Evoxil The firm Now the firm
Pharmaceuticals, 500mg Tablet 2028, 16-01- 500mg had initially has
Lahore Each film 2018, 20,000/- tablet of applied submitted
coated tablet 15-01-2018 Beacon Levofloxaci revised
contains:- pharma n capsules Form-5
(Deposit slip
Levofloxacin as (MHRA) stating tablet
No:0733977) 250mg
Hemihydrate… Levoflox dosage form
…..500mg. 1× 10‘s; As tablet of which was of applied
Fluoroquinolon per SRO Bosch deferred in product with
e Pharma 250th complete
(Reg # meeting. dossier.
023980) The Board
directed that
Inspection applicant
conducted shall either
on 20-12- revise their
2017, formulation
overall to tablet
hygienic dosage form,
condition if not
of the firm registered
was previously
satisfactory and if
, however manufacturin
they were g facility is
advised to approved by
continue CLB (new
improveme registration
nts in QC application
and with
production complete fee)
they .
agreed.
Decision: Approved with USP specification
497. M/s. Welmark Esocon 40mg Form 5 Nexium Deferred in ● The
Pharmaceuticals, Tablets 11-10-2010 40mg 265th meeting firm has
Hattar Each tablet Dy No. 24 tablet of for evidence submitted
contains:- Rs.8000/ MHRA of approval of revised
Esomeprazole… Rs.12,000/- approved. applied Form-5 with
……40mg 31-10-2014 formulation following
2x7‘s Esoproto by reference label claim
(Proton Pump As Per SRO by Wilshire regulatory ●
Inhibitor) Pharma authorities. Each Enteric
● Intern coated tablet
USP Last ationally contains:
Specification inspection available as Esomeprazol
report enteric e (as
dated 01- coated tablet magnesium
09-2016, with trihydrate)…
firm found magnesium ………40mg
to be GMP salt. .
complaint. ● ●

498. M/s. Wnsfield Osteowin 50mg Form-5 NEGMA Deferred in Registration
Pharmaceuticals, Capsules Dy No. 1234 Diacerein 50 264th Board in 269th
Hattar Each capsule 29-10-2010 mg capsule meeting as
contains:- Rs.8000/ (ANSM- meeting
formulation approved the
Diacerin…. Dated 26-10- France)
….50mg 2010 is under
formulation
(Anti- Rs.12000/- Artrodar by review
of Diacerein
osteoarthritic) Dated 26-12-14 Highnoon
50mg capsule
Panel only for the
inspection following
conducted on clinical
18-01-2018
unanimously indication.
recommended
the renewal ―Treatment of
of DML. symptoms of
osteoarthritis
of the hip or
knee joint.‖
Decision: Registration Board approved the formulation for the following clinical indication
only.
“Treatment of symptoms of osteoarthritis of the hip or knee joint.”
499. M/s. AGP Ltd, Dicar Capsule Form-5 Austrian Deferred in Registration
B-23 SITE, Dy. No: 1256 agency for 257th meeting Board in
Karachi. Each capsule dated. health and for as product th
contains: 15.10.2012 food safety 269
is under meeting
Diacerein……... Rs.20,000/-
(The firm has ..50mg Rs.850/30‘s Rein (S.J.& G review /
approved
submitted (Anti- Fazul ellahie) expert
the
change of title inflammatory opinion.
and anti GMP formulation
of the firm
of Diacerein
from M/s. AGP Rheumatic) inspection
Mfg specs conducted 50mg
(Pvt) Ltd, B-23
on18-09-
SITE, Karachi 2017, the capsule
to M/s AGP overall only for the
Ltd, B-23 SITE, compliance
level was following
Karachi)
noted good. clinical
indication.
―Treatment
of
symptoms
of
osteoarthriti
s of the hip
or knee
joint.‖
Decision: Registration Board approved the formulation for the following clinical indication.
“Treatment of symptoms of osteoarthritis of the hip or knee joint.” Moroever Board directed the firm
to submit revised Form 5 under new title of the firm and authorized the Chairman for issuance of
500. M/s. AGP Ltd, Cinpride 1mg Form-5 Spanish Deferred in Registration
B-23 SITE, Tablet Dy. No: 507 Agency of 257th meeting Board
Karachi. Each film coated dated. Medicines for as product approved the
tablet contains: 15.11.2011 and Health
is under formulation
Cinitapride Rs.8,000/- Products
hydrogen 02.08.2013 review / in 277th
(The firm has
submitted tartarate eq Rs.12,000/- expert meeting.
change of title to Rs.255/10‘s Cinita (Getz) opinion.
cinitapride……. The firm has
of the firm
Deferred in submitted fee
from M/s. AGP 1mg GMP
th
(Gastro inspection 277 meeting challan of
(Pvt) Ltd, B-23 prokinetic conducted for Rs. 20,000/-
SITE, Karachi
agent) on18-09- submission of (Deposit slip
to M/s AGP (Mfg. Specs) 2017, the
Ltd, B-23 SITE, fee as the No.
overall
Karachi) compliance firm has 0614245)
level was revised the dated 02-04-
noted good. formulation. 2018.
Decision: Approved with innovator’s specification. Moroever Board directed the firm to submit
revised form 5 under new title of the firm and authorized the Chairman for issuance of registration
letter.
501. M/s Pakistan Zinkid 20mg / Form 5 WHO Registration The firm has
Pharmaceutical 5ml Syrup 30-04-2011 recommen Board stated that it
Products (Pvt.) Each 5ml Dy.No.1056 ded deferred the has come to
Ltd, D-122, contains: Rs.8000/- formulatio
product in our
S.I.T.E, Karachi Elemental Zinc (Photocopy) n th
as zinc sulphate Rs.12,000/- 260 meeting knowledge
monohydratre.. 31-07-2013 Zincat oral for review as that the
……20 mg Pack size & solution of waiting for registration
(Mineral price as per M/s Atco reply of of said
Supplement) leader brand Labs Karachi WHO. product has
(Reg # been issued.
053094)
So we
Inspection request to
conducted please issue
on 12-12- registration
2017
letter for our
concluded
that the product.
firm has
complied/i
mproved
according
to
directions
of the FID.
Panel was
satisfied
for the
improveme
nts
undertaken
by the firm
to comply
with the
observation
s dated 1st
and 2nd
August,
2017. The
panel
advised the
firm to
continue
the
improveme
nts process
as per
cGMP
guidelines.
Decision: Approved with International Pharmacopoeia specification. Challan shall be verified by
B&A division and authorize Chairman Registration Board for issuance of registration letter.
502. M/s Alza Cyclospor Form 5 Restasis Deferred in The firm
th
Pharmaceuticals, 0.05% Rs 20,000/- 0.05% 259 submitted
Al-shifa Trust ophthalmic vide Dy. # ophthalmic meeting for that
Eye Hospital, emulsion 1887 emulsion determining Registration
Jehlum Road, dated of manufacturin Board
Rawalpindi Each ml 19-04-2016 in
Allergan, g st
contains 271 meeting
USFDA requirement
Ciclosporin…… Pack of plastic eye drops decided to
Ophthalmic ……0.5mg bottle 5ml;As Cylor 0.5 (immuno- grant
drops (General) per PRC
mg Eye suppressant) registration
approved in Topical of these
drop of
241st meeting of Immunomodulat
Valor products in
CLB or
Pharmaceu general
USP ticals manufacturin
Specification g areas with
Panel condition
inspection
conducted that
on 07-07- manufacturer
2017 shall provide
recommen safety and
ded for protective
Grant of
measures for
GMP
workers and
certificate.
personnel
which
remain in
direct or are
involved in
close
handling of
these drugs.
Decision: Approved
503. M/s FAAS Tablet Pantocid Form 5 with MHRA Deferred in The firm has
Pharmaceuticals 40mg fee Rs approved 261st meeting stated that
(Pvt.) Ltd, F- Each enteric 20,000/- vide pantoloc - for the our products
748L, S.I.T.E, coated tablet Dy. # 1052 Novartis submission of Pantofaas
Karachi contains dated 23-05- priority as the 20mg Tablet
Pantoprazole (as 2016 Zopent – firm has and
sodium Pack size & Hilton applied for Pantofaas
Sesquihydrate) price as per the 40mg Tablet
40mg SRO Routine registration of were applied
Anti ulcerant / GMP more than 10 for
PPI inspection molecules per registration
USP conducted section dated 24th
Specification on 14-07- May, 2016.
2017 Pantofaas
concluded 20mg tablet
that the was included
current in 275th
level of meeting and
compliance got approved
is rated but Pantofaas
satisfactory 40mg Tablet
. The firm was not
was included in
advised to that meeting.
submit a We request
detailed you to kindly
action plan consider the
and take product in
suitable upcoming
CAPA of meeting.
all the
observation
s stated
above.
Decision: Approved
Evaluator PEC-III
504. M/s Barrett C-Pride 1mg Form-5 8-8-2017 Deferred for confirmation of
Hodgson Tablet Dy. No: 152 confirms approval status by reference
Pakistan Each tablet dated. satisfactory Regulatory authorities (M-
(Pvt) Ltd. contains: 27.09.2013 compliance to 258)
F/423 S.I.T.E. Cinitapride GMP
Rs.20,000/-
Karachi, hydrogen Deferred for the following
Pakistan tartarate eq to Rs.200/10‘s submission:
cinitapride 1000/50‘s ● Change in formulation to
…. 1mg uncoated tablet as per the
(antiemetic) reference product in Spain.
(Mfg. Specs) ● Fee for change of
formulation.
(M-277)
Evaluation by PEC:
Original dossier has been traced and it confirms the following composition:
Each tablet contains:
Cinitapride hydrogen tartrate eq to cinitapride……1mg
505. M/s AultonAlmed 25mg Form 5 Could not be Deferred for evidence of
Pharmaceuticals Tablets Dy No. 268: confirmed approval in reference
, Plot 84/1, Each tablet 09-11-2015 regulatory authorities.
Block A, Phase contains: Rs.20,000/-: 09- Lepride by (M-273)
5, Industrial
Levosulpride 11-2015 Helix
Estate, Hattar ……… 25mg 2x10‘s: As per
Antipsychotics SRO
Firm has
claimed in house
specifications
Evaluation by PEC:
Firm has submitted fee PKR 5,000 (dated 27-3-2018) and revised formulation of uncoated
tablet as per following details
Levosulpride……..25mg
Decision:
506. M/s Aulton Almed 50 mg Form 5 Could not be Deferred for evidence of
Pharmaceuticals Tablets Dy No. 275: confirmed approval in reference
, Plot 84/1, Each film coated 09-11-2015 regulatory authorities.
Block A, Phase tablet contains: Rs.20,000/- Lepride by (M-273)
5, Industrial Levosulpride 9-11-2015 Helix
Estate, Hattar ……… 50mg 2x10‘s: As per
Antipsychotics SRO
Firm has
claimed in house
specifications
Evaluation by PEC:
Firm has submitted fee PKR 5,000 (dated 27-3-2018) and revised formulation of uncoated
tablet as per following details
Levosulpride……..50mg
Decision:
Case No. 04: Registration applications of newly granted DML or New section (Human):
a. New DML
Evaluator PEC-XII
1. M/s Relizon Pharmaceuticals, Lahore. (New Licence)
CLB in its 257th meeting held on 24th -25th January 2018 has considered and granted the Drug
Manufacturing License (DML) to M/ s Relizon Pharmaceuticals and granted three (03) new sections to the
firm. Accordingly, firm has applied for following products for consideration by Drug Registration Board.
Sr. No Section No. of products No. of molecules
1 Tablet (General) 17 10
Section
2 Capsule (General) 21 10
Section
3 Dry Powder 11 08
Suspension (General)
Section
Tablet (General) Section
17 Products/ 10 Molecules
507. Name and Address of Manufacturer / M/s Relizon Pharmaceuticals, Plot No. 118, Sunder
Brand Name + Dosage Form + Strength LEFLOZON TABLET 250mg

Diary No. Date of R & I & fee Each film coated tablet contains:
Levofloxacin (as hemihydrate) …250mg
Composition Diary No:7117, 23/02/2018, Rs. 20,000/-
Pharmacological Group Antibiotics (Fluoroquinolones)
Type of Form Form-5
Pack Size & Demanded Price 10‘s/ As per SRO / 10‘s
Approval Status of Product in Evoxil 250 mg film-coated tablets by M/s Beacon Pharm
Reference Regulatory Authorities. (MHRA approved)
Me-too Status Lazer 250mg Tablet by M/s Foray Pharmaceutical
(Reg No:040615)
GMP Status 05-12-17
Grant of new DML
Panel recommends gran of DML
Brand Name + Dosage Form + Strength LEFLOZON TABLET 500mg

Composition Diary No:7118/, 23/02/2018, Rs. 20,000/-
Type of Form Form-5
Pack Size & Demanded Price 10‘s/ As per SRO
Approval Status of Product in Evoxil 500 mg film-coated tablets by M/s Beacon Pharm
Me-too Status Lazer 500mg Tablet by M/s Foray Pharmaceutical
(Reg No:040614)
GMP Status 05-12-17
Grant of new DML
Brand Name + Dosage Form + Strength C-ZON Tablets 250mg

Ciprofloxacin (as hydrochloride)…250mg
Composition Diary No.7119;23-02-2018; Rs.20,000/-
Type of Form Form-5
Approval Status of Product in Cipro 250mg Tablet by M/s Bayer Health Care
Reference Regulatory Authorities. Pharmaceuticals Inc.USA & Germany (USFDA
Approved)
Me-too Status Mercip 250mg tablet by M/s Merck, (Reg#024601)
GMP Status 05-12-17
Grant of new DML
Decision: Approved.
Brand Name + Dosage Form + Strength C-ZON Tablets 500mg

Ciprofloxacin (as hydrochloride) …500mg
Type of Form Form-5
Pack Size & Demanded Price As per SRO / 10‘s
Approval Status of Product in Cipro 500mg Tablet by M/s Bayer Health Care
Reference Regulatory Authorities. Pharmaceuticals Inc.USA & Germany (USFDA
Approved)
Me-too Status Mercip 500mg Tablet by M/s Merck, (Reg#024602)
GMP Status 05-12-17
Grant of new DML
Decision: Approved.
Brand Name + Dosage Form + Strength Clarizon Tablets 250mg
Diary No. Date of R & I & fee Each film coated tablet contains: -
Clarithromycin ……250mg
Type of Form Form 5
Approval Status of Product in Clarithromycin 250mg Film-coated Tablets by M/s
Reference Regulatory Authorities. Ranbaxy (UK) Limited, (MHRA approved)
Me-too Status Pathocin Tablet 250mg by M/s Wilson Pharmaceuticals
(Reg#016724)
GMP Status 05-12-17
Grant of new DML
Decision: Approved.
Brand Name + Dosage Form + Strength Clarizon Tablets 500mg
Diary No. Date of R & I & fee Each film coated tablet contains: -
Clarithromycin …500mg
Type of Form Form 5
Pack Size & Demanded Price As per SRO
Approval Status of Product in Clarithromycin 500mg Film-coated Tablets by M/s
Reference Regulatory Authorities. Ranbaxy (UK) Limited, (MHRA approved)
Me-too Status CLARION 500MG TABLET by M/s. 'Ferozsons Labs
(Reg#0002873)
GMP Status 05-12-17
Grant of new DML
Decision: Approved.
Brand Name + Dosage Form + Strength Moxizon Tablet 400mg

Diary No. Date of R & I & fee Each film coated tablet contains;
Moxifloxacin (as hydrochloride) ...400mg
Pharmacological Group Fluroquinolones
Type of Form Form-5
Approval Status of Product in Avelox 400 mg film-coated tablets by M/s Bayer plc,
Me-too Status Metoxim 400mg Tablet by M/s Foray Pharmaceutical
(Reg No:056083)
GMP Status 05-12-17
Grant of new DML
Brand Name + Dosage Form + Strength Relizid Tablet 400mg

Linezolid…400 mg
Type of Form Form-5
Pack Size & Demanded Price 5‘s; 10‘s; 12‘s /As per SRO
Approval Status of Product in Zyvox 400 mg tablet by M/s Pharmacia and Upjohn
Reference Regulatory Authorities. Pharma (USFDA)
Me-too Status Barizold 400mg Tablet by M/s Barrett Hodgson (Reg
No:076342)
GMP Status 05-12-17
Grant of new DML
Brand Name + Dosage Form + Strength Relizid Tablet 600mg

Linezolid…600 mg
Type of Form Form-5
Pack Size & Demanded Price 5‘s ; 10‘s; 12‘s/As per SRO
Approval Status of Product in Zyvox 600 mg film-coated tablets by M/s Pharmacia
Reference Regulatory Authorities. Limited, MHRA approved.
Me-too Status Ecasil 600mg tablet by M/s Sami (Reg#066904)
GMP Status 05-12-17
Grant of new DML
Brand Name + Dosage Form + Strength Flurbizon Tablet 100mg
Diary No. Date of R & I & fee Each film-coated tablet contains:
Flurbiprofen …100 mg
Type of Form Form-5
Pack Size & Demanded Price 10‘s; 30‘s/ As per SRO
Approval Status of Product in Teva-Flurbiprofen by Teva Canada Pharm
Reference Regulatory Authorities. (Health Canada Approved)
Me-too Status Neoflarbi 100mg Tablet by M/s Neomedix
GMP Status 05-12-17
Grant of new DML
Decision: Approved.
517. Name and Address of Manufacturer / M/s Relizon Pharmaceuticals,

Applicant Plot No. 118, Sunder Industrial Estate, Raiwind Road,
Lahore.
Brand Name + Dosage Form + Strength Famozon Tablet 20mg
Famotidine………20 mg
Type of Form Form-5
Approval Status of Product in Pepcid tablet 20mg by M/s VALEANT PHARMS
Reference Regulatory Authorities. NORTH. (USFDA Approved))
Me-too Status Famosib 20mg Tablet by M/s Irza Pharmaceuticals
(Reg#054460)
GMP Status 05-12-17
Grant of new DML
Decision: Approved.

Lahore.
Brand Name + Dosage Form + Strength Famozon Tablet 40mg
Famotidine………40 mg
Type of Form Form-5
Approval Status of Product in Pepcid tablet 40mg by M/s VALEANT PHARMS
Reference Regulatory Authorities. NORTH. (USFDA Approved))
Me-too Status Famosib 40mg Tablet by M/s Irza Pharmaceuticals
(Reg#054461)
GMP Status 05-12-17
Grant of new DML
Decision: Approved.

Lahore.
Brand Name + Dosage Form + Strength Malazon Tablet 20mg/120mg
Diary No. Date of R & I & fee Each tablet contains:
Artemether………20 mg
Lumefantrine …...120mg
Pharmacological Group Antimalerial
Type of Form Form-5
Pack Size & Demanded Price 16‘s/ as per SRO
Approval Status of Product in WHO (EML) approved
Me-too Status Coartem Tablets 20mg/120mg by M/s NOVARTIS
PHARMA AG (Reg#025230)
GMP Status 05-12-17
Grant of new DML
Decision:
Approved with IP specification.

Pharmacological Group Synthetic Antimalerial
Type of Form Form-5
Approval Status of Product in WHO (EML) approved
Me-too Status A-Fantrine tablets (40/240) by M/s ATCO Laboratories.
(Reg#053368)
GMP Status 05-12-17
Grant of new DML
Decision: Approved with IP specification.

Lahore.
Pharmacological Group Synthetic Antimalerial
Type of Form Form-5
Approval Status of Product in WHO approved formulation.
Me-too Status A-Fantrine BD tablets (80/480) by M/s ATCO
Laboratories. (Reg#058434))
GMP Status 05-12-17
Grant of new DML
Decision: Approved with IP specification.
Brand Name + Dosage Form + Strength Deslozon tablet 5mg

Desloratadine …5 mg
Pharmacological Group Other antihistamines for systemic use
Type of Form Form-5
Approval Status of Product in Clarinex 5mg Tablet by Merck Sharp Dohme
Reference Regulatory Authorities. (USFDA)
Me-too Status Larinex 5mg Tablet by M/sGetz Pharmaceuticals
(Reg#039175)
GMP Status 05-12-17
Grant of new DML

Lahore.
Brand Name + Dosage Form + Strength Letrozon Tablet 2.5mg
Diary No. Date of R & I & fee Each film-coated tablet contains:
Letrozole…2.5mg.
Pharmacological Group Aromatase inhibitor
Type of Form Form-5
Pack Size & Demanded Price 10‘s; 30‘s tablets/ As per SRO.
Approval Status of Product in FEMARA 2.5 mg Tablet by M/s Novartis Pharmaceuticals
Reference Regulatory Authorities. (USFDA approved)
Me-too Status Aromek 2.5mg Tablet by M/s Glaxy Pharmaceuticals
(Reg#052258)
GMP Status 05-12-17
Grant of new DML
Decision:
Registration Board approved registration of product in general manufacturing areas with
Evaluator PEC-VII
Capsule Section (General)

524. Name and address of Manufacturer / M/s Relizon Pharmaceuticals Plot No. 118, Sunder
Applicant Industrial Estate, Lahore
Brand Name+ Dosage Form+ Strength Azith 250mg Capsule
Azithromycin (as dihydrate) ………250mg
Diary No. Date of R&I & fee Dy No. 2154 ; 23-02-2018; Rs.20,000/-
Type of Form Form-5
Pack Size & Demanded Price 6‘s & 10‘s ; As per SRO
Approval status of product in Zithromax 250mg capsule by M/s Pfizer Ltd.
Reference Regulatory Authorities (USFDA approved)
Me-too status Arozy 250mg Capsule by Aventek Pharmaceuticals
Lahore
GMP status New DML granted Inspection Date 05/12/2017
Remarks of Evaluator ----
Decision: Approved.
Brand Name+DosageForm+Strength Oseltazon 75 mg Capsules
Oseltamivir as Phosphate.... 75mg
Diary No. Date of R&I & fee Dy No. 7139; 23-02-2018; Rs.20,000/-
Pharmacological Group Neuraminidase Inhibitor for the Treatment of influenza
Type of Form Form-5
Pack Size & Demanded Price 10‘s / As per SRO
Approval status of product in Tamiflu 75mg capsule by M/s F. HOFFMANN-LA
Reference Regulatory Authorities ROCHE LTD (USFDA approved)
Me-too status Ostavir-Flu 75mg Capsule by Zafa Pharmaceutical
Laboratories
Decision:Approved.
Brand Name+DosageForm+Strength Venlazon XR 150 mg
Venlafaxine (as hydrochloride) enteric coated pellets
(33%)…………….150mg
Pharmacological Group Serotonin and norepinephrine reuptake inhibitor
Type of Form Form-5
Pack Size & Demanded Price 10‘s
14‘s, / As per SRO
Approval status of product in Alventa XL 150mg prolonged release capsule (MHRA)
Me-too status Efexor of pfizer
Remarks of Evaluator Source is vision pharma.
Source provided is of venlafaxine HCl SR pellets 33.0%
Decision: Approved with innovators specifications.
Brand Name+DosageForm+Strength Lanzon 30mg Capsule
Lansoprazole (8.5%) enteric coated pellets eq. to
Lansoprazole………………..…30mg
Diary No. Date of R&I & fee Dy No.7143; 23-02-2018; Rs.20,000/-
Type of Form Form-5
Pack Size & Demanded Price 14‘s, / As per SRO
Approval status of product in Prevacid 30mg Capsules by Takeda Pharms USA
Me-too status Qpro 30mg Capsules by Bosch Pharmaceuticals
Remarks of Evaluator Source of pellets: Vision pharmaceuticals
Decision: Approved.
Brand Name+DosageForm+Strength Remezon 20mg Capsules
Omeprazole ( Enteric Coated Pellets 8.5%)…20mg
Diary No. Date of R&I & fee Dy No. 7135 ;23-02-2018; Rs.20,000/-
Pharmacological Group Proton Pump inhibitor
Type of Form Form-5
Pack Size & Demanded Price 14‘s , As per SRO
Approval status of product in Prilosec by Astrazeneca Pharmaceuticals in USA
Reference Regulatory Authorities USFDA Approved
Me-too status Aveome 20mg Capsule by Aventek Pharmaceuticals
Lahore
Remarks of Evaluator Source of pellets: Vision Pharmaceuticals, Islamabad.
Decision: Approved.
Brand Name+DosageForm+Strength Remezon 40mg Capsules
Omeprazole ( Enteric Coated Pellets 8.5%)…40mg
Type of Form Form-5
Pack Size & Demanded Price 14‘s , As per SRO
Approval status of product in Prilosec by Astrazeneca Pharmaceuticals in USA
Reference Regulatory Authorities USFDA Approved
Me-too status Aveome 40mg Capsule by Aventek Pharmaceuticals
Lahore
Decision: Approved.
Brand Name+DosageForm+Strength Xeomax 150mg Capsule
Fluconazole….150mg
Type of Form Form-5
Finished Product Specification JP
Approval status of product in Azocan 150 capsule (MHRA)
Me-too status Fungone of Sami Pharmaceuticals
Brand Name+DosageForm+Strength Xeomax 200mg Capsule
Fluconazole….200mg
Diary No. Date of R&I & fee Dy No.7147 ;23-02-2018; Rs.20,000/-
Type of Form Form-5
Finished Product Specification JP Specification
Pack Size & Demanded Price 1‘s, 4‘s; / As per SRO
Approval status of product in Diflucan 200 mg Hard Capsules of Pfizer Limited, UK
Reference Regulatory Authorities (MHRA)
Me-too status Diflucan 200 mg Capsules by Pfizer Labs. Karachi
Brand Name+DosageForm+Strength Diclozon 50mg Capsule
Diclofenac Sodium (Enteric Coated Pellets 32%)....50mg
Type of Form Form-5
Approval status of product in DIFENE 50 Milligram Capsules Gastro-Resistant
Reference Regulatory Authorities (Ireland)
Me-too status Lotofenac 50mg Capsule by Lotus Pharmaceuticals
Islamabad
Remarks of Evaluator ● Source of pellets: Vision Pharmaceuticals,
Islamabad.
● Monograph of Prolong release diclofenac capsule
is present in BP
Brand Name+DosageForm+Strength Diclozon 100mg Capsule
Diclofenac Sodium (Enteric Coated Pellets
32%)....100mg
Type of Form Form-5
Approval status of product in Rhumalgan XL 100 mg modified-release capsules.
Reference Regulatory Authorities (MHRA)
Me-too status Lotofenac 100mg Capsule by Lotus Pharmaceuticals
Islamabad
Remarks of Evaluator ● Source of pellets: Vision Pharmaceuticals,
Islamabad.
● Monograph of Prolong release diclofenac capsule
is present in BP
Brand Name+DosageForm+Strength Gabazon 150mg Capsule
Composition Each Capsule contains
Pregabalin……..150 mg
Type of Form Form-5
Finished Product Specification Innovator‘s Specifications
Approval status of product in Lyrica 150 mg Capsules of PF Prism CV, USA (USFDA)
Me-too status Gabica 150mg Capsule by Getz Pharmaceuticals
Decision:
Type of Form Form-5
Decision:
Type of Form Form-5
Decision:
Type of Form Form-5
Decision:
Brand Name+ Dosage Form+ Strength Gabazon 75mg Capsule
Type of Form Form-5
Diary No. Date of R&I & fee Dy No.7151;23-02-2017; Rs.20,000/-
Type of Form Form-5
Brand Name+DosageForm+Strength Trazone 50 mg capsule
Tramadol hydrochloride….50mg
Type of Form Form-5
Approval status of product in Tramadol 50mg capsule by Milpharm Ltd. (MHRA
Reference Regulatory Authorities Approved)
Me-too status Tramal capsule 50mg by Impex Plus Karachi
Decision: Approved
Brand Name+DosageForm+Strength Esozon 20mg Capsule
Esomeprazole magesnium trihydrate enteric coated
Pellets (22.5%) equivalent to Esomeprazole ….20mg
Diary No. Date of R&I & fee Dy No. 7133;23-02-2018; Rs.20,000/-
Type of Form Form-5
Approval status of product in NEXIUM 20mg capsule by Astra Zeneca
Reference Regulatory Authorities (USFDA Approved)
Me-too status Esdor 20mg Capsule by Aventek Pharmaceuticals Lahore
Decision: Approved
Brand Name+DosageForm+Strength Esozon 40mg Capsule
Esomeprazole magesnium trihydrate enteric coated
Pellets (22.5%) equivalent to Esomeprazole ….40mg
Type of Form Form-5
Approval status of product in NEXIUM 40mg capsules by Astra Zeneca
Reference Regulatory Authorities (USFDA Approved)
Me-too status Esdor 40mg Capsule by Aventek Pharmaceuticals Lahore
Decision:
Approved.
Type of Form Form-5
Approval status of product in Lansoprazole Capsule by Actavis
Reference Regulatory Authorities (MHRA Approved)
Me-too status Lanzol capsule by Pharmatec
Decision:
Approved
Type of Form Form-5
Approval status of product in Prevacid 30mg Capsules by Takeda Pharms USA
Me-too status Qpro 30mg Capsules by Bosch Pharmaceuticals
Decision:
Approved
Brand Name+DosageForm+Strength Venlazon XR 75 mg
Venlafaxine (as hydrochloride)...75 mg (Extended
release pellets 33%)
Source of pellets; Vision pharmaceuticals
Pharmacological Group Serotonin and norepinephrine reuptake inhibitor
Type of Form Form-5
Pack Size & Demanded Price 10‘s
14‘s, / As per SRO
Approval status of product in Alventa XL 75mg Capsule by M/s Consilient Health
Reference Regulatory Authorities Ltd.(MHRA approved)
Me-too status Me-too status VenflaxXR 75mg Capsule by M/s Regal
Pharma.
Remarks of Evaluator Source is vision pharma.
Source provided is of venlafaxine HCl SR pellets 33.0%
Decision:
Section Dry Powder Suspension (General)

Brand Name+DosageForm+Strength Famozon 40mg/5ml Dry Powder Suspension
Composition Each 5 ml after reconstitution contains:
Famotidine…40mg
Pharmacological Group Histamine H2-antagonists
Type of Form Form 5
Pack Size & Demanded Price 60 ml / As per SRO
Approval status of product in Pepcid for oral suspension 40mg/5ml by M/s Salix
Reference Regulatory Authorities Pharma, USFDA
Me-too status Zepsin of Cirin Pharmaceuticals
Decision:
Approved
Brand Name+DosageForm+Strength Secnizon 500mg/30ml Dry Powder Suspension
Secnidazole…..500mg
Pharmacological Group Anti-Protozoal
Type of Form Form 5
Pack Size & Demanded Price 30ml / As per SRO
Approval status of product in NA
Me-too status Secnidal 500mg/30ml suspension of M/s Sanofi Aventis
Karachi.
Remarks of Evaluator Evidence of approval of applied formulation in reference
regulatory authorities/agencies which were
declared/approved by the Registration Board in its 275 th
meeting
In ANSM related to secnizon 500 mg/30 ml,Secnidazole
500 granules is available in sachet form, but the firm has
applied for DS in mono dose bottle.
Decision:
Deferred for the clarification of container closure system as in reference regulatory
authorities the approved drug is in sachet, while the applied drug is in mono dose bottle.
Brand Name+DosageForm+Strength Nitazon 100mg/5ml Dry Powder Suspension
Nitazoxanide…100mg
Pharmacological Group Antiprotozoal
Type of Form Form 5
Pack Size & Demanded Price 30 ml & 60ml / As per SRO
Approval status of product in Alinia powder for Suspension 100mg/5ml by M/s
Reference Regulatory Authorities Romark Pharma Inc., (USFDA Approved)
Me-too status Izato Dry Suspension 100 mg/ 5ml Sami Pharmaceuticals
(Reg#076309)
Decision:
Brand Name+DosageForm+Strength C-Zon 125mg/5ml Dry Powder Suspension
Ciprofloxacin as HCl…..125mg
Pharmacological Group Anti-bacterial Fluoroquinolones
Type of Form Form 5
Approval status of product in Ciprfloxacin for suspension by M/s Lupin ltd USFDA
Reference Regulatory Authorities approved.
Me-too status Ciprin 125mg/5ml suspension of M/s Werrick
pharmaceuticals
Decision:
Approved. Manufacturing requirement for diluent for reconstitution of product shall be
discussed in forthcoming meeting of Registration Board.
Brand Name+DosageForm+Strength C-Zon 250mg/5ml Dry Powder Suspension
Ciprofloxacin as HCl…..250mg
Pharmacological Group Anti-bacterial Fluoroquinolones
Type of Form Form 5
Approval status of product in Ciproxin 250 mg/5 ml granules and solvent for oral
Reference Regulatory Authorities Suspension by M/s Bayer Healthcare, MHRA approved.
Me-too status Ciprin 250mg/5ml suspension of M/s Werrick
pharmaceuticals
Decision:
Approved. Manufacturing requirement for diluent for reconstitution of product shall be
discussed in forthcoming meeting of Registration Board.
Brand Name+DosageForm+Strength Clarizon 125mg/5ml Dry Powder Suspension
Clarithromycin…125mg
Type of Form Form 5
Approval status of product in Clarithromycin 125 mg/5ml suspension
Me-too status Claritek Dry Suspension 125mg/5ml by M/s Getz
Pharma (Reg#009846)
Remarks of Evaluator Source of granules vision pharma (27.5% EC taste mask
pellet
Decision:
Approved.
Brand Name+DosageForm+Strength Clarizon 250mg/5ml Dry Powder Suspension
Clarithromycin…250mg
Type of Form Form 5
Approval status of product in Biaxin granules for oral suspension 250mg/5ml by M/s
Reference Regulatory Authorities Abbvie, USFDA approved.
Me-too status Claritek Dry Suspension 250mg/5ml by M/s Getz
Pharma ( Reg#061347)
Remarks of Evaluator Source of granules vision pharma (27.5% EC taste mask
pellet
Decision:
Approved.
Brand Name+DosageForm+Strength Azith 200mg/5ml Dry Powder Suspension
Type of Form Form-5
Approval status of product in Zithromax Powder for Oral Suspension 200mg/5ml by
Reference Regulatory Authorities M/s Pfizer Limited, MHRA approved.
Me-too status Azomax Dry Suspension by M/s Novartis (Reg#022201)
Decision:
Approved.
Brand Name+DosageForm+Strength Xeomax 50mg/5ml Dry Powder Suspension
Fluconazole…50mg
Type of Form Form 5
Approval status of product in Diflucan 10 mg/ml powder for oral suspension by M/s
Reference Regulatory Authorities Pfizer Limited, MHRA approved.
Me-too status Derocon Dry Suspension50mg/5ml by M/s Raazee
(Reg#027219)
Decision:
Approved.
Brand Name+DosageForm+Strength Malazon DS 30mg/180mg/5ml Dry Powder Suspension
Artemether…30mg
Lumefantrine…180mg
Pharmacological Group Synthetic Antimalarial
Type of Form Form 5
Finished Product Specification IP
Pack Size & Demanded Price 60ml & 90ml / As per SRO
Approval status of product in NA
Me-too status Arceva Dry Suspension by Sami Pharmaceuticals
Remarks of Evaluator ● CO-Artesiane powder for Suspension by M/s Dafra
Pharma Belgium can‘t be verified.
● Evidence of approval of applied formulation in reference
regulatory authorities/agencies which were
declared/approved by the Registration Board

authorities/agencies as adopted by Registration Board in its 275th meeting or by WHO.
Brand Name+DosageForm+Strength Malazon 15mg/90mg/5ml Dry Powder Suspension
Artemether…15mg
Lumefantrine…90mg
Pharmacological Group Synthetic Antimalarial
Type of Form Form 5
Pack Size & Demanded Price 60ml & 90ml / As per SRO
Approval status of product in WHO
Me-too status Arceva Dry Suspension by Sami Pharmaceuticals
Decision:
Approved.
Evaluator PEC-XII
2. M/s MedPharm Research Lab, Lahore. (New Licence)
CLB in its 257th meeting held on 24th -25th January 2018 has considered and granted the Drug Manufacturing
License (DML) to M/s MedPharm Research Lab, Lahore and granted Seven (07) new sections to the firm.
Accordingly, firm has applied for following products for consideration by Drug Registration Board.
1 Dry powder injection 30 10

(Cephalosporin) Section
2 Capsule (Cephalosporin) - -
Section
3 Dry Powder Suspension - -
(Cephalosporin) Section
4 Tablet (General) Section - -
5 Capsule (General) - -
Section
6 Dry powder suspension - -
(General) Section
7 Sachet (General) Section - -
Dry powder injection (Cephalosporin) Section
30 products / 10 molecules
557. Name and address of manufacturer / M/s MedPharm Research Lab.
Applicant 28-Km, Ferozepur Road, Lahore
Brand Name +Dosage Form + Strength Cefamed Dry Powder Injection 250mg (IV)
Diary No. Date of R& I & fee Diary No: 9803, 15-03-2018, Rs: 20,000/-
Ceftriaxone (as sodium)…250mg
Pharmacological Group 3rd Generation Cephalosporin
Type of Form Form-5
Approval status of product in Reference Rocephin IV 250 mg Powder and Solvent for Solution
Regulatory Authorities. for Injection by M/s Roche Products Ltd (MHRA
Approved)
Me-too status Trixone 250mg IV Injection by M/s Aptcure (Pvt) Ltd
(Reg#085225)
Grant of new DML,
Brand Name +Dosage Form + Strength Cefamed Dry Powder Injection 250mg (IM)
Type of Form Form-5
Approval status of product in Reference Rocephin IM 250 mg Powder and Solvent for Solution
Approved)
Me-too status Ceftiheim Injection IM 250mg by M/s Pakheim
International Pharma (Pvt) Ltd (Reg#085193)
Grant of new DML,
Brand Name +Dosage Form + Strength Cefamed Dry Powder Injection 500mg (IV)
Type of Form Form-5
Approval status of product in Reference Rocephin IV 500 mg Powder and Solvent for Solution
Approved)
Me-too status Signum 500 mg Injection I.V by M/s Cherwel
Pharmaceuticals (Pvt) Ltd (Reg#079307)
Grant of new DML,
Brand Name +Dosage Form + Strength Cefamed Dry Powder Injection 500mg (IM)
Type of Form Form-5
Approval status of product in Reference Rocephin IM 500 mg Powder and Solvent for Solution
Approved)
Me-too status Rocimed 500mg Injection I.M by M/s Medicraft
Grant of new DML,
Brand Name +Dosage Form + Strength Cefamed Dry Powder Injection 1g (IV)
Ceftriaxone (as sodium)…1gm
Type of Form Form-5
Approval status of product in Reference Rocephin IV 1 g powder and solvent for solution for
Regulatory Authorities. injection by M/s Roche Products Ltd (MHRA Approved)
Me-too status Signum 1 gm Injection I.V. by M/s Cherwel
Grant of new DML,
Brand Name +Dosage Form + Strength Cefamed Dry Powder Injection 1g (IM)
Ceftriaxone (as sodium)…1gram
Type of Form Form-5
Approval status of product in Reference Rocephin IM 1 g powder and solvent for solution for
Me-too status Lozone Injectin I.M 1gm by M/s Llyods Pharmaceutical
(Reg#027052)
Grant of new DML,
Brand Name +Dosage Form + Strength Cefamed Dry Powder Injection 2g (IV)
Ceftriaxone (as sodium)…2 grams
Type of Form Form-5
Approval status of product in Reference Rocephin IV Injection 2gm By M/s Roche Products
Regulatory Authorities. Limited (MHRA approved)
Me-too status Titan 2gm IV Injection by M/S Macter Pharma (Reg No.
075825)
Grant of new DML,
Brand Name +Dosage Form + Strength Cefamed Dry Powder Injection 2g (IM)
Ceftriaxone (as sodium)…2 grams
Type of Form Form-5
Approval status of product in Reference Not confirmed as IM preparation
Me-too status Traxon 2gm I.M / I.V. Injection by M/s Akhai Pharma
(Reg No. 018248)
Grant of new DML,
Remarks of the Evaluator. ● Approval status of product in Reference Regulatory
Authorities not confirmed as IM preparation.
Brand Name +Dosage Form + Strength Medpactam Dry Powder Injection 1g
Cefoperazone (as sodium)....500mg
Sulbactam (as sodium)....500mg
Pharmacological Group 3rd Generation Cephalosporin + Beta Lactamase Inhibitor
Type of Form Form-5
Approval status of product in Reference PMDA Japan Approved
Me-too status Cebac Injection 1gm by M/s Bosch (Reg#037630)
Grant of new DML,
Decision:
Approved.

Brand Name +Dosage Form + Strength Medpactam Dry Powder Injection 500mg
Cefoperazone (as sodium)....250mg
Sulbactam (as sodium)....250mg
Type of Form Form-5
Approval status of product in Reference PMDA Japan Approved
Me-too status 2Sum Injection 500mg of M/s Sami Pharmaceuticals,
Karachi (Reg.# 079941)
Grant of new DML,
Decision:
Approved.
Brand Name +Dosage Form + Strength Mediroxim Dry Powder Injection 750mg
Cefuroxime (as sodium)…750mg
Pharmacological Group 2nd Generation Cephalosporin
Type of Form Form-5
Pack size & Demanded Price 1‘s/As per SRO
Approval status of product in Reference Cefuroxime 750 mg powder for solution for injection by
Regulatory Authorities. M/s MIP Pharma GmbH (MHRA Approved)
Me-too status ZINACEF 750MG INJ by M/s GSK Pakistan
(Reg#006222)
Grant of new DML,
Decision:
Approved.
Brand Name +Dosage Form + Strength Mediroxim Dry Powder Injection 1.5gm
Cefuroxime (as sodium)…1.5gm
Type of Form Form-5
Approval status of product in Reference Cefuroxime 1.5 g powder for solution for
Regulatory Authorities. injection/infusion by M/s Stragen UK Limited (MHRA
Approved)
Me-too status Zecef Injection 1.5gm by M/s
Bosch Pharmaceuticals (Pvt) Ltd, (Reg#026898)
Grant of new DML,
Decision:
Approved.
Brand Name +Dosage Form + Strength Medipim Dry Powder Injection 500mg
Composition Each Vial Contains:
Cefepime (as hydrochloride)…500mg
With L-Arginine
Pharmacological Group 4th Generation Cephalosporin
Type of Form Form-5
Approval status of product in Reference Cefipime hydrochloride 500mg Injection by M/s
Regulatory Authorities. Hospira, Inc. (USFDA approved)
Me-too status Uspime 500mg Injection by Usawa Pharmaceuicals
(Reg# 060251)
Grant of new DML,
Decision:
Approved.
Brand Name +Dosage Form + Strength Medipim Dry Powder Injection 1 g
Cefepime (as hydrochloride)…1 gm
With L-Arginine
Pharmacological Group 4th Generation Cephalosporin
Type of Form Form-5
Approval status of product in Reference Cefipime hydrochloride 1gm Injection by M/s Hospira,
Regulatory Authorities. Inc. (USFDA approved)
Me-too status Uspime 500mg Injection by Usawa Pharmaceuicals
(Reg# 060250)
Grant of new DML,
Decision:
Approved.
Brand Name +Dosage Form + Strength Medadim Dry Powder Injection 250mg
Ceftazidime (as pentahydrate)…250mg
Type of Form Form-5
Approval status of product in Reference Fortum 250 mg powder for solution for injection by M/s
Regulatory Authorities. GlaxoSmithKline UK (MHRA Approved)
Me-too status Panacef Injection 250mg by M/s CCL (Reg# 023858)
Grant of new DML,
Decision:
Approved.
Brand Name +Dosage Form + Strength Medadim Dry Powder Injection 500mg
Type of Form Form-5
Approval status of product in Reference Fortum 500 mg powder for solution for injection by M/s
Me-too status Panacef Injection 500mg by M/s CCL (Reg# 023859)
Grant of new DML,
Decision:
Approved.
Brand Name +Dosage Form + Strength Medadim Dry Powder Injection 1gm
Ceftazidime (as pentahydrate)…1gm
Type of Form Form-5
Approval status of product in Reference Fortum 1g powder for solution for injection by M/s
Me-too status Panacef Injection 1gm by M/s CCL (Reg# 023986)
Grant of new DML,
Decision:
Approved.
Brand Name +Dosage Form + Strength Medaxim Dry Powder Injection 250mg
Cefotaxime (as sodium)....250mg
Type of Form Form-5
Approval status of product in Reference Claforan Injection 250mg by M/s Aventis Pharma
Regulatory Authorities. Limited (MHRA Approved)
Me-too status Getex Dry powder Injection 250mg by M/s Amarant
from Medicaid, Karachi (Reg#080277)
Grant of new DML,
Decision:
Approved with change of brand name.
Brand Name +Dosage Form + Strength Medaxim Dry Powder Injection 500mg
Type of Form Form-5
Approval status of product in Reference Claforan Injection 500mg by M/s Aventis Pharma
Me-too status Getex Dry powder Injection 500mg by M/s Amarant
from Medicaid, Karachi (Reg#080278)
Grant of new DML,
Decision:
Brand Name +Dosage Form + Strength Medaxim Dry Powder Injection 1gm
Cefotaxime (as sodium)....1gm
Type of Form Form-5
Approval status of product in Reference Claforan Injection 1gm by M/s Aventis Pharma Limited
Me-too status Getex Dry powder Injection 1gm by M/s Amarant from
Medicaid, Karachi (Reg#080279)
Grant of new DML,
Decision:
Brand Name +Dosage Form + Strength Medaxim Dry Powder Injection 1gm IM
Type of Form Form-5
Me-too status Getex Dry powder Injection 1gm by M/s Amarant from
Grant of new DML,
Decision:
Registration Board rejected the application since separate registration of IM & IV vials is not
granted for applied formulation.
Brand Name +Dosage Form + Strength Medaxim Dry Powder Injection 2gm
Type of Form Form-5
Me-too status Claforan 2g Injection by M/s Sanofi Aventis
(Reg.#076156)
Grant of new DML,
Decision:
Brand Name +Dosage Form + Strength Medaxim Dry Powder Injection 2gm IM
Type of Form Form-5
Me-too status Claforan 2g Injection by M/s Sanofi Aventis
(Reg.#076156)
Grant of new DML,
Decision: Registration Board rejected the application since separate registration of IM & IV vials is
not granted for applied formulation.
Brand Name +Dosage Form + Strength Parmazolin Dry Powder Injection 250mg
Cefazolin (as sodium)…250mg
Type of Form Form-5
Approval status of product in Reference Not confirmed
Me-too status Cefamezin 250mg injection by M/s Barrett Hodgson
(Reg#008126)
Grant of new DML,
Decision:
Deferred for evidence of approval of applied formulation in reference regulatory
Brand Name +Dosage Form + Strength Parmazolin Dry Powder Injection 500mg
Cefazolin (as sodium)…500mg
Type of Form Form-5
Approval status of product in Reference Cefazolin For Injection 500mg by M/s Sandoz (USFDA
Me-too status Safelin Injection 500mg by M/s Fassgen Pharmaceuticals
(Reg#074512)
Grant of new DML,
Decision:
Approved.
Brand Name +Dosage Form + Strength Parmazolin Dry Powder Injection 1gm
Cefazolin (as sodium)…1g
Type of Form Form-5
Approval status of product in Reference Cefazolin For Injection 1g by M/s Sandoz (USFDA
Me-too status Safelin Injection 1 gm by M/s Fassgen Pharmaceuticals
(Reg#074513)
Grant of new DML,
Decision: Approved.
Brand Name +Dosage Form + Strength Medadim A Dry Powder Injection 2.5gm
Ceftazidime (as pentahydrate) …2000mg
Avibactam (as sodium)… 500mg
Pharmacological Group 3rd Generation Cephalosporin + beta-lactamase inhibitor
Type of Form Form-5
Finished Product Specification Innovator‘s specifications
Approval status of product in Reference AVYCAZ 2.5 grams single-dose vial by M/s Allergan
Regulatory Authorities. USA, Inc (USFDA Approved)
Me-too status Not confirmed
Grant of new DML,
Remarks of the Evaluator. ● Me-too status not confirmed from available database.
Decision:
Deferred for evidence of applied formulation/drug already approved by DRAP (generic / me-too
status) along with registration number, brand name and name of firm, or else application on form-
5D alongwith differential fee and submission of stability study data.
Brand Name +Dosage Form + Strength Alive Dry Powder Injection 1gm
Cefpirome (as sulphate) ....1000mg
Pharmacological Group 4th generation cephalosporin
Type of Form Form-5
Approval status of product in Reference Cefrom 1 g / 10 ml, powder and solvent for solution for
Regulatory Authorities. injection (IV) by M/s Sanofi Aventis France (ANSM
Approved)
Me-too status Cefrom Injection 1gm by M/s Sanofi Aventis
(Reg#021124)
Grant of new DML,
Decision:
Brand Name +Dosage Form + Strength Medcef Dry Powder Injection 500 mg
Cefoperazone (as sodium)…500mg
Type of Form Form-5
Me-too status CEFOBID Injection 0.5gm by M/s PFIZER
(Reg#013841)
Grant of new DML,
Authorities not confirmed
Decision:
authorities/agencies which were declared/approved by the Registration Board in its 275th meeting
Brand Name +Dosage Form + Strength Medcef Dry Powder Injection 1g
Cefoperazone (as sodium)…1000mg
Type of Form Form-5
Me-too status CEFOBID Injection 1gm by M/s PFIZER (Reg#008524)
Grant of new DML,
Decision:
3. M/s Aulton Pharmaceuticals. Hattar. (Remaining products)
Files received vide letter No. F-16-4/2013(R-IV) dated 15th December 2016. Central Licensing Board granted
approval of Liquid Injection (General), Capsule (General), Dry powder injection (General), Sachet (General),
Eye/ ear drops (General), Cream/ Ointment (General), Dry powder suspension (General) and Tablets (General)
on 03-12-2015.:
The section detail of product(s) is as under:
Sr. No Sections No of drugs Deferred Balance Applied

already products products products
registered
1. Liquid injection 08 0 02 01
(General)
2. Dry powder 01 01 08 02
suspension
(General)
Firm has submitted the following products for consideration by Registration Board.
Dry powder suspension (General)
2 products
587. Name and address of manufacturer / M/s. Aulton Pharmaceuticals
Applicant Plot # 84/1, Block A, Phase 5, Industrial Estate, Hattar.
Brand Name +Dosage Form + Strength Clarton Dry Powder for Suspension 125mg/5ml
Clarithromycin (27.5% taste masked granules) …125mg
Diary No. Date of R& I & fee Diary No: 9021 (Duplicate), 12/03/2018, Rs. 20,000/- (Slip
#0532384 dated 15-01-2016)
Type of Form Form 5
Pack size & Demanded Price 60ml/As per SRO
Approval status of product in Biaxin granules for oral suspension 125mg/5ml by M/s Abbvie,
Reference Regulatory Authorities. USFDA approved.
Me-too status Claritek Dry Suspension 125mg/5ml by M/s Getz Pharma
(Reg#009846)
Routine GMP inspection
Firm is operating at good level of GMP
Remarks of the Evaluator. ● Source of pellets: Vision Pharmaceuticals, Islamabad.
Decision:
Approved.
Brand Name +Dosage Form + Strength Lumix Dry Powder for Suspension 15mg+90mg/5ml
Artemether…15mg
Lumefantrine…90mg
#0559104 dated 18-05-2016)
Pharmacological Group Anti-malarial
Type of Form Form 5
Finished Product Specification International Pharmacopeia Specifications
Pack size & Demanded Price 30ml, 60ml/As per SRO
Approval status of product in WHO prequalified formulation
Me-too status Artem Plus 15/90mg Dry Suspension by M/s Hilton Pharma
(Reg#055015)
Decision:
Approved.
Liquid injection (General)
1 product
Brand Name +Dosage Form + Strength Bicarb 5%w/v Injection
Composition Each 1 ml ampoule contains:
Sodium Bicarbonate…50mg (5%w/v)
#0561017 dated 19-05-2016)
Pharmacological Group Diluent for artesunate injection
Type of Form Form 5
Pack size & Demanded Price 10‘s ampoules/As per SRO
Approval status of product in WHO recommended diluent for Artesunate injection
Me-too status Dasura 50mg/ml Injection by M/s Mediate Pharmaceutical
(Pvt.) Ltd (Reg#061962)
Decision:
Approved as diluent for Artesunate injection
4. M/s T.N Pharmaceuticals (Pvt) Ltd, Lahore (Replacement)
Registration board in its 276th meeting deferred following 03 applications (02 molecules) detailed in column II
for newly approved Tablet (General) section M/s T.N Pharmaceuticals (Pvt) Ltd, Lahore. Now, the firm has
submitted 3 applications (as a replacement) in lieu of these deferred products, as per following details.
Sr. No. Deferred products and composition Requested products for
replacement & composition
I II III
1. CALVIT-D PLUS TABLET 500mg/125 IU Furamed Tablet 50mg
Each film coated tablet contains: Each tablet contains:
Calcium Carbonate 1250mg eq.to Calcium … 500mg Nitrofurantoin…50mg
Vitamin D3 (Cholecalciferol)…125 IU (0.003125mg) …. 20 mg (BP)
(Manufacture‘s specifications)
(Calcium Supplement/ vitamin D)
(M-276)
Decision: Deferred for evidence of approval of applied
formulation in Reference Regulatory
Authorities.
2. CALVIT-D TABLET 125mg/500 IU Each Chewable Tablet Furamed Tablet 100mg
Contains: Each tablet contains:
Elemental Calcium (as Calcium Lactate Pentahydrate and Nitrofurantoin…100mg
Calcium Phosphate) …125mg (BP)
Vitamin D3 (Cholecalciferol)…500 IU (Manufacture‘s
specifications)
(Calcium Supplement/ vitamin D)
(M-276)
Decision: Deferred for evidence of approval of applied
formulation in Reference Regulatory
Authorities.
3. MONTELU-FEX TABLET 10mg/120mg Each Tablet Contains: Gravotin Tablet 50mg
Montelukast(as sodium)…10mg Each tablet contains:
Fexofenadine hydrochloride….120mg (Leukotriene receptor Dimenhydrinate…50mg
antagonist /Antihistamine) (USP)
(M-276)
Decision: Deferred for following reasons:
i. Evidence of approval of applied formulation in reference
regulatory authorities/agencies which were declared/approved by
the Registration Board
ii. Evidence of applied formulation/drug already approved by
DRAP (generic / metoo status) along with registration number,
brand name and name of firm
Decision: Registration Board acceded to firm’s request & decided to dispose off above enlisted three
applications & following applications were considered in replacement.
Tablet Section (General)

3 products/ 2 molecules
590. Name and address of manufacturer / M/s T.N Pharmaceuticals Pvt Ltd.
Applicant Plot No.264-C, Sunder Industrial Estate, Lahore
Brand Name +Dosage Form + Strength Furamed Tablet 50mg
Nitrofurantoin…50mg
Diary No. Date of R& I & fee Diary No:9989, 16/03/2018, Rs. 20,000/-
Pharmacological Group Other antibacterials (Nitrofuran derivatives)
Type of Form Form-5
Pack size & Demanded Price 10x10‘s / Rs. 90/-
Approval status of product in Reference Nitrofurantoin 50 mg Tablets by M/s Dr Reddy‘s
Regulatory Authorities. Laboratories (UK) Limited (MHRA Approved)
Me-too status Furadin 50mg Tablets by M/s Ferozsons Laboratories Ltd
(not confirmed)
GMP status New DML granted 19/7/2017
Remarks of the Evaluator. ● Applied formulation (as film coated tablet) could not
be confirmed from RRA.
● Me-too status not confirmed from available database.
·Evidence of applied formulation/drug already approved by DRAP (generic / me-too status)
· Evidence of approval of applied formulation in reference regulatory authorities/agencies which
were declared/approved by the Registration Board
Brand Name +Dosage Form + Strength Furamed Tablet 100mg
Nitrofurantoin…100mg
Pharmacological Group Other antibacterials (Nitrofuran derivatives)
Type of Form Form-5
Approval status of product in Reference Nitrofurantoin 100 mg Tablets by M/s Teva UK Limited
Me-too status URISTRON 100MG TABLET by M/s WILSON
(Reg#006881)
Decision:
Approved.
Brand Name +Dosage Form + Strength Gravotin Tablet 50mg
Dimenhydrinate…50mg
Type of Form Form-5
Approval status of product in Reference Dimenhydrinate BP 50mg Tablets by M/s Chelonia
Regulatory Authorities. Healthcare Limited (MHRA Approved)
Me-too status Emetox Tablet 50mg by M/s Star Laboratories
(Reg#043369)
Decision: Approved.
5. M/s Welwink Pharmaceuticals. Gujranwala. (Remaining products)
Files received vide letter No. F-6/2016(R-III) dated 27th January 2017. Central Licensing Board granted
approval of Dry powder Injection (General) additional section of M/s Welwink Pharmaceuticals, Gujranwala.
The section detail of molecule(s) and product(s) is as under:
Sr. No Sections Approved Deferred Total Balance of Newly

products products products products submitted
granted products
1. Dry powder 03 (M-237) - 06 04 02
injection 03 (M-247)
(General)
593. Name and address of manufacturer / M/s. Welwink Pharmaceuticals,
Applicant G.T. Road, Industrial Estate, Gujranwala.
Brand Name +Dosage Form + Strength Vincowink 500mg Injection
Composition Each Vial contains:
Vancomycin (as hydrochloride) …500mg
Pharmacological Group Glycopeptide antibacterials
Type of Form Form 5
Pack size & Demanded Price 1‘s vial/As per SRO
Approval status of product in Reference Vancomycin 500mg Powder for Concentrate for Solution
Regulatory Authorities. for Infusion by M/s Actavis UK Ltd, MHRA approved
Me-too status Vancomycin 500mg Vial by M/s Abbott (Reg#015015)
cGMP Inspection Report
Panel concluded that the firm was operating at a
satisfactory level of GMP compliance for all sections
except Liquid Injectable section for which the firm was
advised to provide Liquid particle counter and TOC at
earliest
Remarks of the Evaluator. ● There is no mention of GMP inspection of Dry
powder injection (General) section in the report.
Decision:
Deferred for updated status of GMP of the firm form QA & LT division as inspection report
submitted by firm does not conclude GMP compliant status.
594. Name and address of manufacturer / M/s. Welwink Pharmaceuticals,
Applicant G.T. Road, Industrial Estate, Gujranwala.
Brand Name +Dosage Form + Strength Vincowink 1gm Injection
Vancomycin (as hydrochloride) …1000mg
Pharmacological Group Glycopeptide antibacterials
Type of Form Form 5
Pack size & Demanded Price 1‘s vial/As per SRO
Approval status of product in Reference Vancomycin 1000mg Powder for Concentrate for
Regulatory Authorities. Solution for Infusion by M/s Actavis UK Ltd, MHRA
approved
Me-too status Vancomycin 1gm Vial by M/s Abbott (Reg#015016)
cGMP Inspection Report
Panel concluded that the firm was operating at a
satisfactory level of GMP compliance for all sections
except Liquid Injectable section for which the firm was
advised to provide Liquid particle counter and TOC at
earliest
Remarks of the Evaluator. ● There is no mention of GMP inspection of Dry
powder injection (General) section in the report.
Decision:
Deferred for updated status of GMP of the firm form QA & LT division as inspection report
6. M/s Wenovo Pharmaceuticals. Taxila. (Remaining products)
Files received vide letter No. F-6/2016(R-III) dated 21st February 2018. Central Licensing Board in its 235th
meeting, granted approval of Oral dry powder suspension (Cephalosporin) additional section of M/s Wenovo
Pharmaceuticals, Taxila.
The section detail of molecule(s) and product(s) is as under:
Sr. No Sections Approved Deferred Total Balance of Newly

products products products products submitted
granted products
1. Oral dry 02 (M-245) 0 04 06 02
powder 02 (M-271)
suspension
(Cephalosporin)
2. Capsule 04 (M-243) 03 07 03 02
(Cephalosporin)
595. Name and address of manufacturer / M/s. Wenovo Pharmaceuticals,
Applicant Plot No. 31, 32, Punjab Small Industrial Estate, Taxila.
Brand Name +Dosage Form + Strength Wenoclor 250mg/5ml Dry Suspension
Composition Each 5ml Suspension after reconstitution Contains:
Cefaclor (as monohydrate) …250mg
Type of Form Form 5
Pack size & Demanded Price 60ml /
As per SRO
Approval status of product in Reference Cefaclor 250mg/5ml Suspension by M/s Strides Pharma
Regulatory Authorities. UK Ltd (MHRA approved)
Me-too status Sac-Lor 250mg/5ml Dry Suspension by M/s Semos
Pharma (Reg#081618)
Routine GMP Inspection
GMP compliance of firm is good
Decision:
Approved.
Brand Name +Dosage Form + Strength Wenoclor 125mg/5ml Dry Suspension
Composition Each 5ml Suspension after reconstitution Contains:
Type of Form Form 5
Pack size & Demanded Price 60ml /
As per SRO
Approval status of product in Reference Cefaclor 125mg/5ml Suspension by M/s Strides Pharma
Me-too status Sac-Lor 125mg/5ml Dry Suspension by M/s Semos
Pharma (Reg#081617)
Decision:
Approved.
Brand Name +Dosage Form + Strength Wenoclor 500mg Capsule
Type of Form Form 5
Pack size & Demanded Price 2x6‘s/ As per SRO
Approval status of product in Reference Cefaclor Capsules 500mg by M/s Strides Pharma UK Ltd
Me-too status Faceclor 500mg Capsule by M/s City Karachi
(Reg#070601)
Decision:
Approved.
Brand Name +Dosage Form + Strength Wenoclor 250mg Capsule
Composition Each capsule contains: -
Cefaclor (as monohydrate) ....250mg
Type of Form Form 5
Approval status of product in Reference Cefaclor 250mg Capsules by M/s Ranbaxy (UK) Limited
Me-too status Faceclor 250mg Capsule by M/s City Karachi
(Reg#070600)
Decision: Approved.
b. New/Additional section(s)
Evaluator PEC-XII
7. M/s Hudson Pharma (Pvt) Ltd, Karachi (New Section)
CLB in its 257th meeting held on 24th -25th January 2018 has considered and granted the following two (02)
additional sections of M/ s Hudson Pharma. Accordingly, firm has applied for following products for
consideration by Drug Registration Board.
1 Cream/ ointment/ - -
lotion/ gel (General)
section
2 Capsule Section 17 07
(General)
Capsule Section (General)
599. Name and Address of Manufacturer / M/s Hudson Pharma (Pvt) Ltd,
Applicant Plot No. D-93, North Western Industrial Zone, Port
Qasim, Karachi
Brand Name + Dosage Form + Strength Topium 18mcg Rotacaps
Diary No. Date of R & I & fee Diary No:5743, 16/02/2018, Rs: 20,000/-
Composition Each Rotacap contains:
Tiotropium (as bromide monohydrate) …18mcg
Pharmacological Group Other Drugs for Obstructive Airway Diseases, Inhalants
(Anticholinergics)
Type of Form Form-5
Pack Size & Demanded Price 15‘s, 20‘s/ As per SRO
Approval Status of Product in Reference Spiriva 18 micrograms hard capsules with powder for
Regulatory Authorities. inhalation by M/s Boehringer Ingelheim International
GmbH (Germany Approved)
Me-too Status Tiovair Rotacaps 18mcg by M/s Highnoon Laboratories
Ltd (Reg#054315)
GMP Status 19-01-2018
Panel recommends grant of additional sections
Decision:
600. Name and Address of Manufacturer / M/s Hudson Pharma (Pvt) Ltd, Plot No. D-93, North
Applicant Western Industrial Zone, Port Qasim, Karachi
Brand Name + Dosage Form + Strength Topium-F 18mcg+12mcg Rotacaps
Tiotropium (as bromide monohydrate) …18mcg
Formoterol fumarate …12mcg
(Anticholinergics) + Adrenergics, Inhalants (Selective
beta-2-adrenoreceptor agonists)
Type of Form Form-5
Approval Status of Product in Reference Duova Rotacaps by M/s Cipla Pharmaceuicals, India
Regulatory Authorities. (Not Reference Regulatory Authority)
Me-too Status Tiovair-F Rotacaps 18mcg+12mcg by M/s Highnoon
Laboratories Ltd (Reg#054314)
Remarks of the Evaluator. ● Approval Status of Product in Reference Regulatory
Qasim, Karachi
Brand Name + Dosage Form + Strength Bunide 100mcg Rotacaps
Budesonide… 100mcg
(Glucocorticoids)
Type of Form Form-5
Approval Status of Product in Reference Budesonide 100 Micrograms Dry Powder Inhaler by
Regulatory Authorities. M/s AstraZeneca (MHRA Approved)
Me-too Status Budevair 100 Rotacaps by M/s Highnoon Laboratories
Ltd (Reg#054313)
Remarks of the Evaluator. Evidence of rotacaps is not found in Reference
Regulatory Authorities. This formulation is available as
Pulmicort available in a multidose inspiratory flow
driven, metered dose dry powder inhaler (Turbuhaler).
Decision: Registration Board deliberated that instant product is in unit dose preparation /
rotacap having same dose per actuation as in multidose product. Thus Registration Board
approved the product.
Qasim, Karachi
Budesonide …200mcg
(Glucocorticoids)
Type of Form Form-5
Ltd (Reg#054312)
Remarks of the Evaluator. ● Evidence of rotacaps is not found in Reference
Regulatory Authorities. This formulation is
available as Pulmicort available in a multidose
inspiratory flow driven, metered dose dry powder
inhaler (Turbuhaler).
Qasim, Karachi
(Glucocorticoids)
Type of Form Form-5
Ltd (Reg#054318)
Remarks of the Evaluator. Evidence of rotacaps is not found in Reference
Regulatory Authorities. This formulation is available as
Pulmicort available in a multidose inspiratory flow
driven, metered dose dry powder inhaler (Turbuhaler).
Decision:
Registration Board deliberated that instant product is in unit dose preparation / rotacap having
same dose per actuation as in multidose product. Thus Registration Board approved the product.
Qasim, Karachi
Brand Name + Dosage Form + Strength Bunide-F 100mcg+6mcg Rotacaps
Pharmacological Group Adrenergics, Inhalants (Adrenergics in combination
with corticosteroids or other drugs, excl.
anticholinergics)
Type of Form Form-5
Approval Status of Product in Reference Symbicort 100/6 Turbohaler, Inhalation Powder by M/s
Regulatory Authorities. AstraZeneca (MHRA Approved)
Me-too Status Combivair 100mcg+6mcg Rotacaps by M/s Highnoon
available as Symbicort available in a multidose
Decision:
Qasim, Karachi
anticholinergics)
Type of Form Form-5
Approval Status of Product in Reference Symbicort 200/6 Turbohaler, Inhalation Powder by M/s
Regulatory Authorities. AstraZeneca (MHRA Approved)
available as Symbicort available in a multidose
Decision:
Applicant Plot No.D-93, North Western Industrial Zone, Port
Qasim, Karachi
anticholinergics)
Type of Form Form-5
Approval Status of Product in Reference Not confirmed
Decision:
Qasim, Karachi
Brand Name + Dosage Form + Strength Beclotide 100mcg Rotacaps
Beclomethasone dipropionate …100mcg
(Glucocorticoids)
Type of Form Form-5
Approval Status of Product in Reference Pulvinal Beclometasone Dipropionate 100
Regulatory Authorities. micrograms/metered dose inhalation powder by M/s
Chiesi Limited (MHRA Approved)
Me-too Status Betatec 100 Rotacaps by M/s Highnoon Laboratories
Ltd (Reg#043458)
available as, metered dose dry powder inhaler.
Qasim, Karachi
(Glucocorticoids)
Type of Form Form-5
Ltd (Reg#043459)
Decision:
Qasim, Karachi
(Glucocorticoids)
Type of Form Form-5
Ltd (Reg#044703)
Decision:
Qasim, Karachi
Brand Name + Dosage Form + Strength Beclotide-S 100mcg+200mcg Rotacaps
Salbutamol sulfate …200mcg
anticholinergics)
Type of Form Form-5
Approval Status of Product in Reference Not confirmed.
Me-too Status Breavent-B Rotacaps 100mcg+200mcg by M/s
Highnoon Laboratories Ltd (Reg#044594)
authorities/agencies which were declared/approved by the Registration Board in its 275th
meeting.
Qasim, Karachi
Brand Name + Dosage Form + Strength Beclotide-S 200mcg+400mcg Rotacaps
Salbutamol sulfate …400mcg
anticholinergics)
Type of Form Form-5
Me-too Status Breavent-B Rotacaps 200mcg+400mcg by M/s
Highnoon Laboratories Ltd (Reg#044595)
authorities/agencies which were declared/approved by the Registration Board in its 275 th
meeting.
Qasim, Karachi
Brand Name + Dosage Form + Strength Hivair 50mcg+25mcg Rotacaps
Fluticasone propionate …50mcg
Salmeterol (as xinafoate) …25mcg
anticholinergics)
Type of Form Form-5
Approval Status of Product in Reference Seretide 50 Evohaler by M/s Glaxo Wellcome
Regulatory Authorities. S.A.(MHRA Approved)
Me-too Status Wiltide Plus 25/50mcg Automized Powder Capsules by
M/s Wilson‘s Pharmaceuticals (Reg#038486)
Qasim, Karachi
anticholinergics)
Type of Form Form-5
Approval Status of Product in Reference SERETIDE 125 EVOHALER by M/s Glaxo Wellcome
Me-too Status Wiltide Plus 25/125mcg Automized Powder Capsules
by M/s Wilson‘s Pharmaceuticals (Reg#038469)
Qasim, Karachi
anticholinergics)
Type of Form Form-5
Approval Status of Product in Reference SERETIDE 250 EVOHALER by M/s Glaxo Wellcome
Regulatory Authorities. S.A (MHRA Approved)
Me-too Status Wiltide Plus 25/250mcg Automized Powder Capsules
by M/s Wilson‘s Pharmaceuticals (Reg#038470)
Qasim, Karachi
Salmeterol Xinafoate …50mcg
anticholinergics)
Type of Form Form 5-D
Approval Status of Product in Reference Seretide Accuhaler 50/250 by M/s Glaxo Wellcome S.A
Me-too Status SERETIDE DISKUS 50/250MCG POWDER FOR
INHALATION by M/s GLAXO WELLCOME
PRODUCTION (Reg#074727)
● Evidence of rotacaps from me-too database not
confirmed.
● Firm has applied on Form 5-D without submission
of stability study data
Decision: Deferred for submission of stability studies data and related documents as per decision
of 278th meeting of Registration board.
8. M/s Pacific Pharmaceuticals (Pvt) Ltd, Lahore. (New Section)
CLB in its 257th meeting held on 24th -25th January 2018 has considered and granted the (03) additional
sections to M/s Pacific Pharmaceuticals (Pvt) Ltd. Accordingly, firm has applied for following products for
1 Capsule 02 01
(Psychotropic/
Narcotic) Section
2 Tablet (Psychotropic/ 01 01
Narcotic) Section
3 Tablet (Hormone) 08 08
Section
Capsule (Psychotropic/ Narcotic) Section
02 Products/ 01 Molecule
616. Name and Address of Manufacturer / M/s Pacific Pharmaceuticals (Pvt) Ltd,
Applicant 30-km, Multan Road, Lahore.
Brand Name + Dosage Form + Strength Mazepam 15 mg Capsules
Diary No. Date of R & I & fee Diary No:10925, 26/03/2018, Rs. 20,000/-
Temazepam…15mg
Pharmacological Group Benzodiazepine derivatives
Type of Form Form-5
Pack Size & Demanded Price 1x10‘s, 1x30‘s/ As per SRO
Approval Status of Product in Reference Restoril (temazepam) Capsules 15 mg by M/s Mallinckrodt
Me-too Status Restoril 15mg capsule by M/s Sandoz (Reg#009684)
Panel recommends grant of Additional sections
Remarks of the Evaluator. Alternative brand name: Noctapam
Decision:
Approved.
617. Name and Address of Manufacturer / M/s Pacific Pharmaceuticals Ltd,
Brand Name + Dosage Form + Strength Mazepam 30 mg Capsules
Temazepam…30mg
Type of Form Form-5
Pack Size & Demanded Price 1x10‘s, 1x30‘s/ As per SRO
Approval Status of Product in Reference Restoril (temazepam) Capsules 30 mg by M/s Mallinckrodt
Me-too Status Restoril 30mg capsule by M/s Sandoz (Reg#009685)
Remarks of the Evaluator. Alternative brand name: Noctapam
Decision:
Approved.
Tablet (Psychotropic/ Narcotic) Section
01 Product/ 01 Molecule
Brand Name + Dosage Form + Strength Epizolam 7.5mg Tablets
Midazolam…15mg
Type of Form Form-5
Pack Size & Demanded Price 1x10‘s/ As per SRO
Approval Status of Product in Reference Midazolam Orpha 15mg film-coated tablet by M/s Orpha-
Regulatory Authorities. Devel Trade und (Sweden Approved)
Me-too Status PROLID TABLET 7.5mg by M/s Stanley Pharmaceuticals
(Pvt) Ltd (Reg#005825)
Remarks of the Evaluator. ● Formulation is approved as film coated tablet in RRA
while firm has applied as plain tablet.
● Approved formulation in RRA has midazolam (as
maleate) while firm has applied as midazolam as base.
Tablet (Hormone) Section
08 Products/ 08 Molecule
Brand Name + Dosage Form + Strength Exestane 25mg Tablets
Exemestane…25mg
Pharmacological Group Aromatase inhibitors (Steroidal)
Type of Form Form-5
Approval Status of Product in Reference Aromasin 25 mg coated tablets by M/s Pfizer Limited
Me-too Status Ph&T Exemestane 25mg Coated Tablets by M/s Mehran
International (Reg#078122)
Decision: The Board deferred product and advised the firm to get approval from Licensing
Division particularly for either Tablet (Steroidal Hormone) or Tablet (Non-steroidal Horomone)
for further processing by Registration Board.
Brand Name + Dosage Form + Strength Fina-Grow 1mg Tablets
Finasteride…25mg
Pharmacological Group Testosterone-5-alpha reductase inhibitors
Type of Form Form-5
Approval Status of Product in Reference Finasteride 1 mg Film-coated Tablets by M/s TEVA UK
Regulatory Authorities. Ltd (MHRA Approved)
Me-too Status Hairfin Tablets 1mg by M/s Elko Organization
(Reg#034771)
Decision:
The Board deferred product and advised the firm to get approval from Licensing Division
particularly for either Tablet (Steroidal Hormone) or Tablet (Non-steroidal Horomone) for
further processing by Registration Board.
Brand Name + Dosage Form + Strength Pill Plus Tablets
Gestodene… 0.075mg
Ethinylestradiol… 0.02mg
Pharmacological Group Hormonal contraceptives for systemic use (Progestogens
and estrogens, fixed combinations)
Type of Form Form-5
Approval Status of Product in Reference Aidulan 20/75 microgram film-coated tablets by M/s Lupin
Regulatory Authorities. (Europe) Ltd (MHRA Approved)
Me-too Status Meliane Tablets by M/s Medipharm (Pvt) Ltd
(Reg#024076)
Brand Name + Dosage Form + Strength Pro-Gest Tablets
Dydrogesterone… 10mg
Pharmacological Group Progestogens (Pregnadien derivatives)
Type of Form Form-5
Approval Status of Product in Reference Duphaston 10 mg film-coated tablets by M/s Mylan IRE
Regulatory Authorities. Healthcare Limited (Ireland Approved)
Me-too Status Duphaston 10mg Tablets by M/s HIGHNOON
(Reg#006654)
Remarks of the Evaluator. Alternative brand name: Dydrogest, Gestogest
Decision:
particularly for either Tablet (Steroidal Hormone) or Tablet (Non-steroidal Horomone)

Brand Name + Dosage Form + Strength Femme-Safe Tablets 1.5mg
Levonorgestrel … 1.5mg
Pharmacological Group Hormonal contraceptives for systemic use (Progestogens)
Type of Form Form-5
Approval Status of Product in Reference Levonorgestrel 1.5 mg tablet by M/s Gedeon Richter Plc.
Me-too Status Not confirmed
Remarks of the Evaluator. ● Me-too Status not confirmed from available database.
Decision:

Brand Name + Dosage Form + Strength Androstat Tablets 50mg
Cyproterone acetate … 50mg
Pharmacological Group Antiandrogen
Type of Form Form-5
Approval Status of Product in Reference Androcur 50 mg tablets by M/s Bayer plc (MHRA
Me-too Status Androcur 50 mg tablets by M/s ALI GOHAR & CO
(Reg#010221)
Decision:
Brand Name + Dosage Form + Strength Allure Tablets 0.035/2mg
Cyproterone acetate … 2mg
Ethinylestradiol… 0.035mg
Pharmacological Group Antiandrogens and estrogens
Type of Form Form-5
Approval Status of Product in Reference Acnocin 2000/35 Tablets by M/s Sandoz Limited (MHRA
Me-too Status DIANE-35 TABLETS by M/s ALI GOHAR & CO
(Reg#011467)
Brand Name + Dosage Form + Strength Pro-Man Tablets 25mg
Mesterolone… 25mg
Pharmacological Group Androgen (5-androstanon (3) derivative)
Type of Form Form-5
Approval Status of Product in Reference Pro-viron Tablets by M/s Bayer plc (MHRA Approved)
Me-too Status Androviron 25mg Tablets by M/s Global Pharmaceutical
(Reg#030471)
Decision:
9. M/s Theramed Pharmaceutical (Pvt) Ltd, Lahore (New Section)
CLB in its 257th meeting held on 24th -25th January 2018 has considered and granted the following two (02)
additional sections of M/s Theramed Pharmaceutical (Pvt) Ltd. Accordingly, firm has applied for following
products for consideration by Drug Registration Board.
1 Tablet (Psychotropic) 09 04
Section
2 Capsule - -
(Psychotropic) Section
Tablet (Psychotropic) Section
627. Name and Address of Manufacturer / M/s Theramed Pharmaceutical (Pvt) Ltd,
Brand Name + Dosage Form + Strength Clomed 0.5mg Tablet
Composition Each Tablet contains:
Clonazepam…0.5 mg
Type of Form Form-5
Approval Status of Product in Reference Clonazepam Auden 500mcg Tablets by M/s Auden
Regulatory Authorities. Mckenzie (Pharma Division) Ltd (MHRA Approved)
Me-too Status Tovir 0.5mg Tablet by M/s Adamjee (Reg#080335)
Panel recommended grant of additional sections
Decision:
Brand Name + Dosage Form + Strength Clomed 2mg Tablet
Clonazepam…2 mg
Type of Form Form-5
Approval Status of Product in Reference Clonazepam Auden 2mg Tablets by M/s Auden Mckenzie
Regulatory Authorities. (Pharma Division) Ltd (MHRA Approved)
Me-too Status Tovir 2mg Tablet by M/s Adamjee (Reg#080336)
Decision:
Brand Name + Dosage Form + Strength Zolmed 10mg Tablet
Zolpidem tartarate…10mg
Pharmacological Group Benzodiazepine related drugs
Type of Form Form-5
Pack Size & Demanded Price 10‘s, 20‘s, 30‘s / As per SRO
Approval Status of Product in Reference Zolpidem 10 mg Film-Coated Tablets by M/s Generics
Regulatory Authorities. [UK] Limited (MHRA Approved)
Me-too Status Somnia 10mg Tablets by M/s Wilshire Laboratories (Pvt)
Ltd (Reg#067737)
Decision:
Brand Name + Dosage Form + Strength L-Pam 1mg Tablet
Lorazepam…1mg
Type of Form Form-5
Pack Size & Demanded Price 30‘s, 50‘s, 100‘s/ As per SRO
Approval Status of Product in Reference Lorazepam 1mg Tablets by M/s Genus Pharmaceuticals
Regulatory Authorities. Holdings Limited (MHRA Approved)
Me-too Status Lorazepam 1 mg Tablets by M/s Heal Pharmaceuticals
(Reg#079396)
Decision:
Approved.
Brand Name + Dosage Form + Strength L-Pam 2mg Tablet
Lorazepam…2mg
Type of Form Form-5
Pack Size & Demanded Price 30‘s, 50‘s, 100‘s/ As per SRO
Approval Status of Product in Reference Ativan Tablets 2mg by M/s Valeant Pharmaceuticals
Me-too Status Lorazepam 2 mg Tablets by M/s Heal Pharmaceuticals
(Reg#079397)
Decision:
Approved.
Brand Name + Dosage Form + Strength Alz 0.25mg Tablet
Alprazolam…0.25 mg
Type of Form Form-5
Approval Status of Product in Reference Xanax 250 microgram Tablets by M/s Pfizer Limited
Me-too Status Alprazolam 0.25mg Tablets by M/s Heal Pharmaceuticals
(Reg#079390)
Decision:
Approved.
Brand Name + Dosage Form + Strength Alz 0.5mg Tablet
Alprazolam…0.5mg
Type of Form Form-5
Approval Status of Product in Reference Xanax 500 microgram Tablets by M/s Pfizer Limited
Me-too Status Alprazolam 0.5mg Tablets by M/s Heal Pharmaceuticals
(Reg#079391)
Decision:
Approved.
Brand Name + Dosage Form + Strength Alz 1mg Tablet
Alprazolam…1 mg
Type of Form Form-5
Approval Status of Product in Reference ALPRAZOLAM MYLAN 1 mg, scored tablet by M/s
Regulatory Authorities. MYLAN SAS (ANSM France Approved)
Me-too Status Alprazolam 1 mg Tablets by M/s Heal Pharmaceuticals
(Reg#079392)
Decision:
Approved.
Brand Name + Dosage Form + Strength Alz 2mg Tablet
Alprazolam…2 mg
Type of Form Form-5
Approval Status of Product in Reference ALPRAZOLAM 2 mg TABLETS, USP by M/s JAMP
Regulatory Authorities. Pharma Corporation (Health Canada Approved)
Me-too Status Pranax 2 mg Tablets by M/s Aries Pharma (Pvt.) Ltd.
(Reg#079370)
Decision:
Approved.
10. M/s Kanel Pharma. Islamabad. (New Section)
CLB in its 257th meeting held on 24th -25th January 2018 has considered and granted the following five (05)
additional sections of M/ s Kanel Pharma. Accordingly, firm has applied for following products for
1 Cream/ ointment 11 10
section (General)
2 Topical lotion section 11 10
(General)
3 Capsule Section 07 05
(Cephalosporin)
4 Dry suspension 10 05
section
(Cephalosporin)
5 Dry vial injection 19 07
(Cephalosporin)
Cream/ ointment section (General)
636. Name and Address of Manufacturer / M/s Kanel Pharma, Plot No.6, Street No. SS-3, National
Applicant Industrial Zone, Rawat Islamabad.
Brand Name + Dosage Form + Strength Kazma Cream
Fluocinolone acetonide…0.1mg (0.01%w/w)
Hydroquinone…40mg (4%w/w)
Tretinoin…0.5mg (0.05%w/w)
Pharmacological Group Corticosteroid+ melanin synthesis inhibitor+retinoid
Type of Form Form-5
Pack Size & Demanded Price 10g/ As per SRO
Approval Status of Product in Reference TRI-LUMA Cream 0.01%/4%/0.05% by M/s
Regulatory Authorities. GALDERMA laboratories, L.P (USFDA Approved)
Me-too Status Trimelasin Cream by M/s Valor Pharmaceuticals
(Reg#031104)
Grant of additional sections
Decision:
637. Name and Address of Manufacturer / M/s Kanel Pharma,
Applicant Plot No.6, Street No. SS-3, National Industrial Zone, Rawat
Islamabad.
Brand Name + Dosage Form + Strength Clotrim-H Cream
Clotrimazole…10mg (1% w/w)
Hydrocortisone (as acetate)… 10mg (1% w/w)
Pharmacological Group Corticosteroids and antiinfectives in combination
Type of Form Form-5
Approval Status of Product in Reference Canesten HC Cream by M/s Bayer plc (MHRA Approved)
Me-too Status Hydrozole Cream by M/s Stiefel Laboratories Pakistan
Decision:
Approved.
Islamabad.
Brand Name + Dosage Form + Strength DERMICARE-H CREAM
Fusidic Acid…20mg (2%w/w)
Hydrocortisone acetate…10mg (1%w/w)
Pharmacological Group Antibiotic in combination with corticosteroid
Type of Form Form-5
Pack Size & Demanded Price 5g ,15g, 10g / As per SRO
Approval Status of Product in Reference Fucidin H Cream by M/s LEO Laboratories Limited
Me-too Status Fosic-H Cream by M/s Metro Pharmaceuticals (Reg.
082039)
Decision:
Islamabad.
Brand Name + Dosage Form + Strength Acne-Free Gel
Isotretinoin…0.5mg (0.05% w/w)
Pharmacological Group Vitamin A derivative
Type of Form Form-5
Pack Size & Demanded Price 10 gm / As per SRO
Approval Status of Product in Reference Isotrex 0.05% w/w Gel by M/s Stiefel Laboratories, Inc.
Me-too Status Iso-Scot Gel 0.05%w/w by M/s Scotman Pharma
(Reg#034960)
Decision:
Islamabad.
Brand Name + Dosage Form + Strength Tacrogran Ointment 0.03%w/w
Tacrolimus (as monohydrate)…0.3mg (0.03%w/w)
Pharmacological Group Agents for dermatitis, excluding corticosteroids
Type of Form Form-5
Pack Size & Demanded Price 10g, 30g/ As per SRO
Approval Status of Product in Reference Protopic Ointment 0.03% by M/s Astellas Pharma US, Inc.
Me-too Status Eczemus Ointment 0.03% by M/s Brookes
Decision: Registration Board approved registration of product with innovator’s specification in

general manufacturing areas with condition that manufacturer shall provide safety and protective
measures for workers and personnel which remain in direct contact or are involved in close
handling of these drugs.
Islamabad.
Brand Name + Dosage Form + Strength Acne-Free Plus Gel
Composition Each gram contains;
Isotretinoin…0.5mg (0.05% w/w)
Erythromycin…20mg (2% w/w)
Pharmacological Group Anti-Acne Preparations for Topical Use (Retinoid +
Antiinfective)
Type of Form Form-5
Pack Size & Demanded Price 10g / As per SRO
Approval Status of Product in Reference Isotrexin Gel (isotretinoin 0.05%/erythromycin 2%) by M/s
Regulatory Authorities. Star Pharmaceuticals Ltd. (MHRA Approved)
Me-too Status Isotrexin Gel by M/s Stiefel Laboratories (Reg#047552)

Decision:
Approved with change of brand name and as per Innovator's specifications.
Islamabad.
Brand Name + Dosage Form + Strength Dermicare Cream 2%w/w
Type of Form Form-5
Pack Size & Demanded Price 15g, 10g / As per SRO
Approval Status of Product in Reference Fucidin 20mg/gm Cream by M/s Leo Laboratories Limited
Me-too Status Udic 2% Cream by M/s Ciba
Pharmaceuticals.(Reg#081566)
Decision:
Approved.
Islamabad.
Brand Name + Dosage Form + Strength Gentaken-B Ointment
Gentamicin (as sulphate)…1mg (0.1% w/w)
Betamethasone (as valerate)…1mg (0.1% w/w)
Pharmacological Group Corticosteroid +Antibiotic
Type of Form Form-5
Approval Status of Product in Reference VALISONE-G OINTMENT by M/s Valeant Canada
Regulatory Authorities. LP/Valeant Canada S.E.C. (Health Canada Approved)
Me-too Status Genticyn B Ointment by M/s Reckitt & Colman
(Reg#010185)
Decision:
Islamabad.
Brand Name + Dosage Form + Strength Dermicare-B Cream.
Betamethasone (as valerate) …1mg (0.1%w/w)
Pharmacological Group Antibiotic in combination with corticosteroid
Type of Form Form-5
Approval Status of Product in Reference Fucibet Cream by M/s LEO Laboratories Limited (MHRA
Me-too Status Sidik-B Cream by M/s Danas Pharmaceutical (Pvt) Ltd
(Reg#038723)
Decision:
Approved with change of brand name and as per Innovators specifications.
Islamabad.
Brand Name + Dosage Form + Strength Clinfection Plus Gel
Clindamycin (as phosphate) …10mg (1%w/w) Anhydrous
benzoyl peroxide (as hydrous benzoyl peroxide) …50mg
(5%w/w)
Pharmacological Group Antiinfective +Peroxide (anti-acne preparations for topical
use)
Type of Form Form-5
Pack Size & Demanded Price 10g / As per SRO
Approval Status of Product in Reference Duac Once Daily 10 mg/g + 50 mg/g Gel by M/s
Regulatory Authorities. GlaxoSmithKline UK Limited (MHRA Approved)
Me-too Status Duac Once Daily Gel by M/s Stiefel Laboratories Pakistan
Decision:
Approved and as per innovator’s specification.
Islamabad.
Brand Name + Dosage Form + Strength Tacrogran Ointment 0.1%w/w
Tacrolimus (as monohydrate) …1mg (0.1%w/w)
Pharmacological Group Agents for dermatitis, excluding corticosteroids
Type of Form Form-5
Approval Status of Product in Reference Dermitopic 0.1 % ointment by M/s PharmaSwiss
Regulatory Authorities. Česká republika s.r.o. (MHRA Approved)
Me-too Status Eczemus Ointment 0.1% by M/s Brookes Pharmaceuticals
(Reg#045493)
Decision: Registration Board approved registration of product with in general manufacturing

areas with condition that manufacturer shall provide safety and protective measures for workers
and personnel which remain in direct contact or are involved in close handling of these drugs.
Topical lotion section (General)

Islamabad.
Brand Name + Dosage Form + Strength Betnoken Lotion 0.1% w/w
Betamethasone (as valerate) …1mg (0.1% w/w)
Pharmacological Group Corticosteroid
Type of Form Form-5
Pack Size & Demanded Price 20ml/ As per SRO
Approval Status of Product in Reference Betnovate Lotion 0.1% w/w by M/s Glaxo Wellcome UK
Me-too Status Betamethasone Lotion 0.1% by M/s Werrick
Decision:
Approved with change in brand name
Islamabad.
Brand Name + Dosage Form + Strength Ketzol Shampoo 2% w/w
Ketoconazole…20mg (2% w/w)
Pharmacological Group Antifungal (Imidazole and triazole derivative)
Type of Form Form-5
Approval Status of Product in Reference Nizoral Anti-Dandruff Shampoo by M/s McNeil Products
Me-too Status Ketonaz Lotion by M/s Sante (Reg#073453)
Decision:
Approved.
Islamabad.
Brand Name + Dosage Form + Strength Scabiton Lotion
Crotamiton…100mg (10%w/w)
Sulphur…20mg (2%w/w)
Pharmacological Group Scabicidal and antipruritic
Type of Form Form-5
Me-too Status SEBION 2GM LOTION by M/s Atco (Reg#012229)
Decision: Deferred for evidence of approval of applied formulation in reference
regulatory authorities/agencies which were declared/approved by the Registration Board
in its 275th meeting.
Islamabad.
Brand Name + Dosage Form + Strength Kermithrin Lotion 5 %w/w
Permethrin…50mg (5 %w/w)
Pharmacological Group Ectoparasiticides, incl. Scabicides
Type of Form Form-5
Approval Status of Product in Reference Permethrin Lotion 5% w/w by M/s GlaxoSmithKline
Regulatory Authorities. Consumer Healthcare (UK) Trading Limited (MHRA
Approved)
Me-too Status Permilot Lotion 5% by M/s Semos (Reg#076033)

Decision:
Islamabad.
Brand Name + Dosage Form + Strength Hair-Gro Solution 2%w/v
Minoxidil…20mg (2%w/v)
Pharmacological Group Dermatologicals
Type of Form Form-5
Approval Status of Product in Reference Minoxidil Dermapharm 20 mg/ml cutaneous spray,
Regulatory Authorities. Solution by M/s Dermapharm AG (MHRA Approved)
Me-too Status Xinodil Lotion 2% by M/s Trigon Pharmaceutical (Pvt)
Limited (Reg#042766)
Decision:
Islamabad.
Brand Name + Dosage Form + Strength Hair-Gro Solution 5%w/v
Minoxidil…50mg (5%w/v)
Pharmacological Group Dermatologicals
Type of Form Form-5
Approval Status of Product in Reference Regaine for Men Extra Strength Scalp Solution 5% w/v
Regulatory Authorities. Cutaneous Solution by M/s McNeil Products Limited
(MHRA Approved)
Me-too Status Higrow Topical Solution 5%w/v by M/s Shaigan
(Reg#052658)
Decision:
Islamabad.
Brand Name + Dosage Form + Strength Mometakan Lotion 0.1%w/w
Mometasone furoate…1mg (0.1%w/w)
Type of Form Form-5
Approval Status of Product in Reference Elocon Scalp Lotion 0.1% w/w by M/s Quadrant
Regulatory Authorities. Pharmaceuticals (MHRA Approved)
Me-too Status Metasone Lotion 0.1% by M/s Elko Organization
(Reg#037039)
Decision:
Approved.
Islamabad.
Brand Name + Dosage Form + Strength Clinfection Lotion 1% w/v
Clindamycin (as phosphate) …10mg (1%w/v)
Pharmacological Group Antiinfectives for treatment of acne
Type of Form Form-5
Approval Status of Product in Reference Dalacin T Topical Lotion by M/s Star Pharmaceuticals Ltd
Me-too Status Austaclin-T Lotion by M/s Bloom Pharmaceuticals (Pvt)
Ltd (Reg#063077)
Decision:
Approved.
Islamabad.
Brand Name + Dosage Form + Strength Dandruff- Free Lotion 1.5% w/w
Ciclopirox Olamine…15mg (1.5% w/w)
Pharmacological Group Other antifungals for topical use
Type of Form Form-5
Pack Size & Demanded Price 60ml, 90ml, 120ml/ As per SRO
Approval Status of Product in Reference Sebiprox 15 mg/g shampoo by M/s Stiefel Farma, S.A.
Regulatory Authorities. (Spain Approved)
Me-too Status Stieprox Topical Liquid by M/s GSK (Reg#026392)

Decision:
Islamabad.
Brand Name + Dosage Form + Strength Diprokalic Lotion
Betamethasone Dipropionate…0.5mg (0.05%w/w)
Salicylic acid…20mg (2%w/w)
Pharmacological Group Corticosteroids, potent, combinations with antifungals for
topical use
Type of Form Form-5
Finished Product Specification Innovator's specifications
Pack Size & Demanded Price 25ml, 60ml /As per SRO
Approval Status of Product in Reference Diprosalic Scalp Application 0.05% w/w / 2% w/w,
Regulatory Authorities. cutaneous solution by M/s Merck Sharp & Dohme Limited
(MHRA Approved)
Me-too Status Betasaly lotion by Valor Pharmaceuticals (Reg# 065247)

Decision:
Islamabad.
Brand Name + Dosage Form + Strength Montal Solution
Salicylic acid…167mg (16.7% w/w)
Lactic acid…167mg (16.7% w/w)
Pharmacological Group Keratolytic agent, Wart and anti-corn preparations
Type of Form Form-5
Approval Status of Product in Reference Salactol Collodion by M/s Diomed Developments Limited
Me-too Status Duoflim Topical Application by M/s Stiefels USA fazal din
& sons (Reg#005032)
Decision:
Capsule Section (Cephalosporin)
Islamabad.
Brand Name + Dosage Form + Strength Kanadrox 500 mg Capsule
Cefadroxil (as monohydrate) …500mg
Type of Form Form 5
Approval Status of Product in Reference Cefadroxil 500 mg capsules, hard by M/s Alkaloid-INT
Regulatory Authorities. d.o.o. (MHRA Approved)
Me-too Status Evacef 500mg Capsules by M/s Highnoon Laboratories,
(Reg#009141)
Decision:
Approved.
Islamabad.
Brand Name + Dosage Form + Strength Kanxime 200 mg Capsule
Cefixime (as trihydrate) …200mg
Type of Form Form 5
Pack Size & Demanded Price 5‘s/As per SRO
Approval Status of Product in Reference Approved by Spain
Me-too Status Soxime Capsule 200 mg by Swat Pharmaceuticals
(Reg#060127)
Decision:
Approved
Islamabad.
Brand Name + Dosage Form + Strength Kanxime 400 mg Capsule
Type of Form Form 5
Approval Status of Product in Reference SUPRAX 400mg capsules by M/s Lupin Pharma (USFDA
Me-too Status Soxime Capsule 400 mg by Swat Pharmaceuticals
(Reg#060128)
Decision:
Approved.
Islamabad.
Brand Name + Dosage Form + Strength K-Clor 500mg Capsule
Cefaclor (as monohydrate) ...500mg
Type of Form Form 5
Pack Size & Demanded Price As per SRO
Approval Status of Product in Reference Cefaclor Capsules 500mg by M/s Strides Pharma UK Ltd
Me-too Status Faceclor 500mg Capsule by M/s City Karachi
(Reg#070601)
Decision:
Approved.
Islamabad.
Brand Name + Dosage Form + Strength Velokane 250 mg Capsule
Cephradine …250mg
Type of Form Form 5
Approval Status of Product in Reference Cefradine 250mg Capsules by M/s Athlone
Regulatory Authorities. Pharmaceuticals Limited (MHRA Approved)
Me-too Status Zasinol 250mg capsule byM/s Martin Dow (Reg#080643)

Decision:
Approved.
Islamabad.
Brand Name + Dosage Form + Strength Velokane 500 mg Capsule
Cephradine …500mg
Type of Form Form 5
Approval Status of Product in Reference Cephradine 500mg capsule by M/s Athlone
Regulatory Authorities. Pharmaceuticals Limited (MHRA Approved)
Me-too Status Biocef Capsules 500mg by M/s International Brands (Reg#
013508)
Decision:
Approved.
Islamabad.
Brand Name + Dosage Form + Strength KP-Dox 100mg capsules
Cefpodoxime …100mg
Type of Form Form 5
Approval Status of Product in Reference Not confirmed.
Me-too Status Ipod 100 mg Capsules by M/s Genome Pharmaceuticals
(Pvt,) Ltd (Reg# 075529)
Dry suspension section (Cephalosporin)

665. Name and Address of Manufacturer / M/s Kanel Pharma, Plot No.6, Street No. SS-3, National
Applicant Industrial Zone, Rawat Islamabad.
Brand Name + Dosage Form + Strength K-Clor 125mg/5ml Dry Suspension
Type of Form Form 5
Pack Size & Demanded Price 60ml/As per SRO
Approval Status of Product in Reference Cefaclor 125mg/5ml Suspension by M/s Strides Pharma
Me-too Status Sac-Lor 125mg/5ml Dry Suspension by M/s Semos Pharma
(Reg#081617)
Decision:
Approved.
Islamabad.
Brand Name + Dosage Form + Strength K-Clor 250mg/5ml Dry Suspension
Type of Form Form 5
Approval Status of Product in Reference Cefaclor 250mg/5ml Suspension by M/s Strides Pharma
Me-too Status Sac-Lor 250mg/5ml Dry Suspension by M/s Semos Pharma
(Reg#081618)
Decision:
Approved.
Islamabad.
Brand Name + Dosage Form + Strength Kanxime 100mg/5ml Dry Suspension
Type of Form Form 5
Approval Status of Product in Reference Cefixime 100 mg/5 ml Powder for Oral Suspension by M/s
Regulatory Authorities. Generics [UK] Ltd t/a Mylan (MHRA Approved)
Me-too Status Stlicef dry suspension 100mg/5ml by M/s Treat Pharma
(Reg#073247)
Decision:
Approved.
Islamabad.
Brand Name + Dosage Form + Strength Kanxime 200mg/5ml Dry Suspension
Type of Form Form 5
Approval Status of Product in Reference Cefixime for oral suspension 200mg/5ml by M/s
Regulatory Authorities. Aurobindo Pharma (USFDA approved)
Me-too Status Biozil Dry Suspension 200mg/5ml by M/s Biolabs
(Reg#054770)
Decision:
Approved.
Islamabad.
Brand Name + Dosage Form + Strength KP-dox 40mg/5ml Dry Suspension
Cefpodoxime (as proxetil) …40mg
Type of Form Form 5
Approval Status of Product in Reference Cefpodoxime Proxetil 40 mg/5 ml Powder for Oral
Regulatory Authorities. Suspension by M/s Sandoz GMBH, (MHRA approved)
Me-too Status Apodox Dry Suspension by M/s Alliance (Reg#054697)

Decision:
Approved.
Islamabad.
Brand Name + Dosage Form + Strength KP-dox 100mg/5ml Dry Suspension
Cefpodoxime (as proxetil)…100mg
Type of Form Form 5
Approval Status of Product in Reference Cefpodoxime Proxetil 100 mg/5 ml Powder for Oral
Regulatory Authorities. Suspension by M/s Sandoz (USFDA approved)
Me-too Status Qink 100mg/5ml Dry Suspension by Wilshire/Horizon
(Reg#053636)
Decision: Approved.

Islamabad.
Brand Name + Dosage Form + Strength Cure-Cef 125mg/5ml Dry Suspension
Type of Form Form 5
Approval Status of Product in Reference ORACEFAL 125 mg / 5 ml powder for oral suspension by
Regulatory Authorities. M/s (ANSM Approved)
Me-too Status Evacef Suspension 125mg/5ml by M/s Highnoon
Laboratories, Lahore (Reg#011213)
Decision:
Islamabad.
Brand Name + Dosage Form + Strength Cure-Cef 250mg/5ml Dry Suspension
Type of Form Form 5
Approval Status of Product in Reference Duricef 125mg/5ml by M/s Warner Chilcott, (USFDA
Regulatory Authorities. Approved) Duricef
Me-too Status Evacef Suspension 250mg/5ml by M/s Highnoon
Decision:

Islamabad.
Brand Name + Dosage Form + Strength Velokane 125mg/5ml Dry Suspension
Cephradine (as monohydrate) …125mg
Type of Form Form 5
Me-too Status Licef Dry Powder suspension 125mg/5ml by M/s Wisdom
Decision:
Islamabad.
Brand Name + Dosage Form + Strength Velokane 250mg/5ml Dry Suspension
Cephradine …250mg
Type of Form Form 5
Approval Status of Product in Reference Cefradine 250mg/5ml dry powder for syrup by M/s Strides
Regulatory Authorities. Pharma UK Ltd (MHRA Approved)
Me-too Status Licef Dry Powder suspension 250mg/5ml by M/s Wisdom
Decision:
Approved.
Dry vial injection (Cephalosporin)
Islamabad.
Brand Name + Dosage Form + Strength Kanpime 1g IM/IV Injection.
Cefepime (as hydrochloride) …1 gm
With L-Arginine
Type of Form Form 5
Approval Status of Product in Reference Cefipime hydrochloride 1gm Injection by M/s Hospira, Inc.
Me-too Status Uspime 500mg Injection by Usawa Pharmaceuicals (Reg#
060250)
Decision:
Approved.
Islamabad.
Brand Name + Dosage Form + Strength Kanpime 500mg IM/IV Injection.
Cefepime (as hydrochloride) …500mg
With L-Arginine
Type of Form Form 5
Approval Status of Product in Reference Cefipime hydrochloride 500mg Injection by M/s Hospira,
Regulatory Authorities. Inc. (USFDA approved)
Me-too Status Uspime 500mg Injection by Usawa Pharmaceuicals (Reg#
060251)
Decision:
Approved.
Islamabad.
Brand Name + Dosage Form + Strength Tri-Zone 250mg IV Injection.
Composition Each vial contains: -
Ceftriaxone (as sodium) ....250mg
Type of Form Form 5
Approval Status of Product in Reference Rocephin IV 250 mg powder and solvent for solution for
Regulatory Authorities. injection by M/s Roche Products Ltd, (MHRA Approved)
Me-too Status Antrix Injection 250mg IV by M/s Fynk (Reg#062723)

Decision:
Islamabad.
Brand Name + Dosage Form + Strength Oximet 250mg IM Injection.
Ceftriaxone (as sodium) ....250mg
Type of Form Form 5
Approval Status of Product in Reference Rocephin IM 250 mg powder and solvent for solution for
Regulatory Authorities. injection by M/s Roche Products Ltd, (MHRA Approved)
Me-too Status Amtraxa I/M 250mg Injection by M/s Amarant
(Reg#080280)
Decision:
Approved.
Islamabad.
Brand Name + Dosage Form + Strength Tri-Zone 500mg IV Injection.
Ceftriaxone (as sodium) …500mg
Type of Form Form 5
Approval Status of Product in Reference Rocephin IV 500 mg Powder and Solvent for Solution for
Regulatory Authorities. Injection by M/s Roche Products Ltd (MHRA Approved)
Me-too Status Signum 500 mg Injection I.V by M/s Cherwel
Decision:
Islamabad.
Brand Name + Dosage Form + Strength Oximet 500mg IM Injection.
Ceftriaxone (as sodium) …500mg
Type of Form Form 5
Approval Status of Product in Reference Rocephin IM 500 mg Powder and Solvent for Solution for
Regulatory Authorities. Injection by M/s Roche Products Ltd (MHRA Approved)
Me-too Status Rocimed 500mg Injection I.M by M/s Medicraft
Decision:
Approved.
Islamabad.
Brand Name + Dosage Form + Strength Tri-Zone 1g IV Injection.
Ceftriaxone (as sodium) …1gm
Type of Form Form 5
Approval Status of Product in Reference Rocephin IV 1 g powder and solvent for solution for
Me-too Status Signum 1 gm Injection I.V. by M/s Cherwel
Decision:
Islamabad.
Brand Name + Dosage Form + Strength Zonokane 1g Injection IM/IV Injection.
Cefoperazone (as sodium) …1000mg
Type of Form Form 5
Approval Status of Product in Reference CEFOBID 1g Injection by M/s Pfizer (USFDA
Regulatory Authorities. Discontinued)
Me-too Status CEFAPEZONE -IM/IV INJECTION 1g by M/s High-Q
(Reg#014947)
Decision:
Islamabad.
Brand Name + Dosage Form + Strength Zonobact 1g Injection IM/IV Injection.
Cefoperazone (as sodium) ....500mg
Sulbactam (as sodium) ....500mg
Type of Form Form 5
Approval Status of Product in Reference PMDA Japan Approved
Me-too Status Cebac Injection 1gm by M/s Bosch (Reg#037630)

Decision:
Approved.
Islamabad.
Brand Name + Dosage Form + Strength Zonobact 2g Injection IM/IV Injection.
Cefoperazone (as sodium) …1 gram
Sulbactam (as sodium) …1 gram
Type of Form Form 5
Approval Status of Product in Reference Approved in Europe (Poland, Slovakia, Czech
Regulatory Authorities. Republic) by EMA
Me-too Status Cebac Injection 2gm by M/s Bosch (Reg#037631)

Decision:
Approved.
Islamabad.
Brand Name + Dosage Form + Strength Taxikane 250mg IM/IV Injection.
Type of Form Form 5
Approval Status of Product in Reference Claforan Injection 250mg by M/s Aventis Pharma Limited
Me-too Status Getex Dry powder Injection 250mg by M/s Amarant from
Decision:
Approved.
Islamabad.
Brand Name + Dosage Form + Strength Taxikane 500mg IM/IV Injection.
Cefotaxime (as sodium) ....500mg
Type of Form Form 5
Approval Status of Product in Reference Claforan Injection 500mg by M/s Aventis Pharma Limited
Me-too Status Getex Dry Powder Injection 500mg by M/s Amarant from
Decision:
Approved.
Islamabad.
Brand Name + Dosage Form + Strength Taxikane 1g IM/IV Injection.
Cefotaxime (as sodium) ....1gm
Type of Form Form 5
Approval Status of Product in Reference Claforan Injection 1gm by M/s Aventis Pharma Limited
Me-too Status Getex Dry powder Injection 1gm by M/s Amarant from
Decision:
Approved.
Islamabad.
Brand Name + Dosage Form + Strength Velokane 250mg IM/IV Injection
Type of Form Form 5
Approval Status of Product in Reference VELOSEF 250mg Injection by M/s APOTHECON
Regulatory Authorities. (USFDA Discontinued)
Me-too Status V-Sef Injection 250mg by M/s Z-JANS Pharmaceuticals
(Reg#024067)
authorities/agencies s adopted by Registration Board in its 275th meeting.
Islamabad.
Brand Name + Dosage Form + Strength Velokane 500mg IM/IV Injection
Type of Form Form 5
(Reg#024068)
authorities/agencies s adopted by Registration Board in its 275th meeting.
Islamabad.
Brand Name + Dosage Form + Strength Velokane 1g IM/IV Injection
Type of Form Form 5
(Reg#024069)
Islamabad.
Brand Name + Dosage Form + Strength Kanvador 250mg IM/IV Injection
Type of Form Form 5
Approval Status of Product in Reference Fortum 250 mg powder for solution for injection by M/s
Me-too Status Panacef Injection 250mg by M/s CCL (Reg# 023858)

Decision:
Approved.
Islamabad.
Brand Name + Dosage Form + Strength Kanvador 500mg IM/IV Injection
Type of Form Form 5
Approval Status of Product in Reference Fortum 500 mg powder for solution for injection by M/s
Me-too Status Panacef Injection 500mg by M/s CCL (Reg# 023859)

Decision:
Approved.
Islamabad.
Brand Name + Dosage Form + Strength Kanvador 1g IM/IV Injection
Ceftazidime (as pentahydrate)…1gm
Type of Form Form 5
Approval Status of Product in Reference Fortum 1g powder for solution for injection by M/s
Me-too Status Panacef Injection 1gm by M/s CCL (Reg# 023986)

Decision:
Approved.
11. M/s Skims Pharmaceuticals, Faisalabad. (New Section)
CLB in its 257th meeting held on 24th -25th January 2018 has considered and granted (04) additional sections to
M/s Skims Pharmaceuticals, Faisalabad. Accordingly, firm has applied for following products for
1 Tablet Section - -
(General).
2 Capsule (General) - -
Section
3 Oral Dry Powder - -
Suspension (General)
Section.
4 Oral Dry Powder 05 04
Sachet (General)
Section
Oral Dry Powder Sachet (General) Section
694. Name and Address of Manufacturer / M/s Skims Pharmaceuticals,
Applicant 10-B, Value Addition City Khurrianwala, Faisalabad.
Brand Name + Dosage Form + Strength Achlor Insta 20 Sachet
Composition Each Sachet contains:
Omeprazole……….…20mg.
Sodium bicarbonate…1680mg.
Pharmacological Group Proton pump inhibitor/ Antacid.
Type of Form Form-5
Pack Size & Demanded Price 10‘s/ As per SRO.
Approval Status of Product in Reference Zegerid Sachet 20mg/1680mg powders by M/s
Regulatory Authorities. SANTARUS INC (USFDA approved)
Me-too Status RULING+ 20mg/1680mg powders by M/s High-Q.
(Reg#070634)
Decision:
Approved.

Brand Name + Dosage Form + Strength Achlor Insta 40 Sachet
Type of Form Form-5
Approval Status of Product in Reference Zegerid Sachet 40mg/1680mg powders by M/s
Me-too Status RULING+ 40mg/1680mg powders by M/s High-Q.
(Reg#070633)
Decision:
Approved.
Brand Name + Dosage Form + Strength Skikast 4mg sachet
Montelukast sodium…4mg.
Pharmacological Group Leukotriene receptor antagonist.
Type of Form Form-5
Approval Status of Product in Reference Singulair Paediatric 4 Mg Granules by M/s Merck Sharp &
Regulatory Authorities. Dohme Ltd.(MHRA approved)
Me-too Status Singulair 4mg powder by M/s OBS (Reg# 031377)
Decision:
Approved.
Brand Name + Dosage Form + Strength Skifen 600mg sachet
Ibuprofen…600mg
Type of Form Form 5
Approval Status of Product in Reference Brufen Granules 600mg by M/s BGP Products Ltd.
Me-too Status Hibufen 600mg Sachet by M/s Hirani (Reg#081554)
Remarks of the Evaluator. Approved formulation in MHRA contains Ibuprofen
effervescent granules but formulation applied by the firm
has no mention of effervescent granules.
Brand Name + Dosage Form + Strength Skidral 3gm sachet
Dioctahedral smectite…3gm
Pharmacological Group Anti-diarrheal
Type of Form Form-5
Finished Product Specification Innovator‘s specifications.
Pack Size & Demanded Price 30‘s/ As Per SRO
Approval Status of Product in Reference Smecta 3 g powder for oral suspension in sachet by M/s
Regulatory Authorities. Ipsen Pharma (ANSM approved)
Me-too Status Diosecta 3g sachet by M/s Woodwards Pharma. (Reg#
061111)
Evaluator PEC-IV
Capsule General
699. Name and address of manufacturer / M/s Skims Pharmaceuticals, 10/B Value Addition City,
Applicant Khurrianwala, Faisalabad.
Brand Name +Dosage Form + Strength SKIZIT CAPSULES 250 mg
Azithromycin (as dihydrate) ………250mg
Diary No. Date of R& I & fee Dy.No; 6332 Date:20-02-18 , Rs.20,000/-
Type of Form Form-5
Pack size & Demanded Price 10‘s & As per SRO
Approval status of product in Reference Zithromax 250mg capsule by M/s Pfizer Ltd.
Regulatory Authorities. (MHRA approved)
Me-too status Azomax 250mg capsule by M/s Sandoz
Pharmaceuticals.(Reg#022200)
GMP status Grant of Additional Section Approved dated:21-02-18
Decision: Approved
700. Name and address of manufacturer / M/s skims Pharmaceuticals, 10/B Value Addition City,
Brand Name +Dosage Form + Strength SKIDOX CAPSULES 100 mg
Doxycycline Hyclate eq. to Doxycycline……..100mg
Pharmacological Group Antibiotic (Tetracyclines)
Type of Form Form-5
Pack size & Demanded Price 10×10‘s & As per SRO
Approval status of product in Reference Vibramycin of USFDA Approved
Me-too status Dok-C-M Capsule 100mg of M/s Mediate
Pharmaceuticals
Decision: Approved
Brand Name +Dosage Form + Strength EMO 20 CAPSULES 20 mg
Esomeprazole (as magnesium Trihydrate) enteric coated
pellets.....20mg
Diary No. Date of R& I & fee Dy.No;6334 Date:20-02-18 , Rs.20,000/-
Type of Form Form-5
Approval status of product in Reference Nexium 20 mg for capsule Of (USFDA Approved)
Me-too status Esomap Capsules 20mg by M/s Efroze Chemical
Brand Name +Dosage Form + Strength EMO 40 CAPSULES 40 mg
Esomeprazole (as magnesium Trihydrate) enteric coated
pellets.....40mg
Type of Form Form-5
Approval status of product in Reference Nexium 20 mg for capsule Of (USFDA Approved)
Me-too status Esomap Capsules 20mg by M/s Efroze Chemical
Brand Name +Dosage Form + Strength LINCAP CAPSULES 500 mg
Lincomycin (as hydrochloride)…500mg
Diary No. Date of R& I & fee Dy.No.6333 Date:20-02-18 , Rs.20,000/-
Pharmacological Group Antibiotics
Type of Form Form-5
Approval status of product in Reference Lincocine 500 mg Capsule by M/s Pfizer Holding France
Regulatory Authorities. (ANSM approved)
Me-too status F-Linco 500mg capsule by M/s Fresh Pharmaceuticals
Decision: Approved.
Brand Name +Dosage Form + Strength ACHLOR 20 CAPSULES 20 mg
Composition Each capsule contains :
Omeprazole (Enteric Coated Pellets 8.5%)…20mg
Type of Form Form-5
Approval status of product in Reference Losec capsule Of (MHRA Approved)
Me-too status Losec 20mg capsule by M/s Barrett Hodgson
Remarks of Evaluator Source of pellets: Vision Pharmaceuticals, Islamaba
Decision: Approved.
Brand Name +Dosage Form + Strength ACHLOR 40 CAPSULES 40 mg
Composition Each capsule contains :
Omeprazole (Enteric Coated Pellets 8.5%)…40mg
Type of Form Form-5
Approval status of product in Reference Losec capsule Of (MHRA Approved)
Me-too status Losec 40mg capsule by M/s Barrett Hodgson
Decision: Approved.
Brand Name +Dosage Form + Strength SKIDOL CAPSULES 50 mg
Tramadol HCl….50mg
Type of Form Form-5
Approval status of product in Reference Tramadol Hydrochloride capsules 50mg
Regulatory Authorities. (Approved by MHRA)
Me-too status Magadol 50mg Capsule of M/s Safe Pharmaceuticals,.
Remarks of Evaluator Tramadol HCl capsule available in BP pharmacopeia
while firm mentioned USP Specifications
Decision: Approved.
Brand Name +Dosage Form + Strength SKIROX CAPSULES 10 mg
Piroxicam ………....10mg
Type of Form Form-5
Approval status of product in Reference Feldene Capsules 10mg of
Regulatory Authorities. (Approved by USFDA)
Me-too status Feldene 10 mg Capsule of M/s Pfizer
Decision: Approved.
Brand Name +Dosage Form + Strength SKIROX CAPSULES 20 mg
Piroxicam ………....20mg
Type of Form Form-5
Approval status of product in Reference Feldene Capsules 20mg of
Regulatory Authorities. (Approved by USFDA)
Me-too status Feldene 20 mg Capsule by M/s Pfizer
Decision: Approved.
Brand Name +Dosage Form + Strength SKIFENAC SR 100mg CAPSULES
Diclofenac Sodium SR pellets ………....100mg
Type of Form Form-5
Approval status of product in Reference Rhumalgan XL 100 mg modified-release capsules of
Me-too status Med-Diclo 100mg Capsules of M/s Meditech
pharmaceuticals
● Stability study of 3 batches of pellets.
● Certificate of analysis of pellets
Dry Powder Suspension

Brand Name +Dosage Form + Strength SKIZIT DRY POWDER SUSPENSION 200 mg/5ml
Diary No. Date of R& I & fee Dy. No; 6322. Date:20-02-18 , Rs.20,000/-
Type of Form Form-5
Pack size & Demanded Price 15 ml & As per SRO
Approval status of product in Reference Zithromax Powder for Oral Suspension 200mg/5ml by
Regulatory Authorities. M/s Pfizer Limited, MHRA approved
Decision: Approved.
Brand Name +Dosage Form + Strength SKICLAR DRY POWDER SUSPENSION 125 mg/5 ml
Clarithromycin (as EC taste masked granules
27.5%)…125mg
Type of Form Form-5
Approval status of product in Reference Biaxin granules for oral suspension 125mg/5ml by M/s
Regulatory Authorities. Abbvie, USFDA approved.
Me-too status Rethro 125mg/5ml Dry Suspension by M/s Regal
Pharmaceuticals
Remarks of Evaluator Source of granules: Vision pharmaceuticals
Decision: Approved.
Brand Name +Dosage Form + Strength SKICLAR DS DRY POWDER SUSPENSION
250 mg/5 ml
Clarithromycin (as EC taste masked granules
27.5%)…250mg
Type of Form Form-5
Regulatory Authorities. Abbvie, USFDA approved
Pharmaceuticals
Remarks of Evaluator Source of granules: Vision pharmaceuticals
Decision: Approved.
Brand Name +Dosage Form + Strength SKIFAM DRY POWDER SUSPENSION 40 mg/5ml
Composition Each 5 ml (after reconstitution) contains:
Famotidine ..........40 mg
Pharmacological Group H2-receptor antagonist
Type of Form Form-5
Approval status of product in Reference Pepcid 40 mg/5 ml of Salix Pharma Inc., USA (USFDA)
Me-too status Antidine Dry powder suspension 40 mg/5 ml of Fynk
Pharmaceuticals
Decision: Approved.
Brand Name +Dosage Form + Strength SKIMETHER DRY POWDER SUSPENSION
Artemether….15mg
Lumefantrine….90mg
Type of Form Form-5
Finished Product Specification Manufacturer Specification
Approval status of product in Reference WHO Approved Formulation
Me-too status Artem Plus 15/90mg Dry Suspension by M/s Hilton
Pharma (Reg#055015)
Decision: Approved with Innovator Specification
Brand Name +Dosage Form + Strength SKIMETHER DS DRY POWDER SUSPENSION
Artemether….30mg
Type of Form Form-5
Finished Product Specification International Pharmacopoeia
Me-too status Mala Plus Suspension by M/s. Werrick Pharmaceuticals
Remarks of Evaluator ● Evidence of approval of applied formulation in
reference regulatory authorities/agencies which
were declared/approved by the Registration Board
in its 275th meeting.
authorities/agencies as adopted by the Registration Board in its 275th meeting.
Brand Name +Dosage Form + Strength SKICIN DRY POWDER SUSPENSION 125 mg/5 ml
Composition After reconstitution each 5ml contains:
Ciprofloxacin hydrochloride eq.to ciprofloxacin….125mg
Pharmacological Group Quinolone Antibiotic
Type of Form Form-5
Finished Product Specification Manufacturer specification

Approval status of product in Reference Cipro 250mg/5ml of Bayer Healthcare,(USFDA)
Me-too status Novidat 125mg/5ml of Sami Pharmaceuticals
Remarks of Evaluator Source of granules: Vision Pharmaceuticals, Islamabad.
● Clarification regarding diluent used.
Decision: Approved with innovator’s specification.Manufacturing requirements for diluents for
reconstitution of product shall be discussed in Registration board
Brand Name +Dosage Form + Strength SKICIN DRY POWDER SUSPENSION 250 mg/5 ml
Ciprofloxacin as hydrochloride (taste Mask micro pellets
35%)…….250mg
Diary No. Date of R& I & fee Dy.No; 6347 Date:20-02-18 , Rs.20,000/-/-( 2 challan of
Rs;20000/- and Rs;1230 of balance fee)
Pharmacological Group Quinolone Antibiotic
Type of Form Form-5
Approval status of product in Reference Ciproxin® 250 mg/5 ml granules and solvent for oral
Regulatory Authorities. suspension by M/s Bayer Healthcare, MHRA
approved
Me-too status Novidat Dry suspension 250mg/5ml by M/s Sami
Pharmaceuticals
Remarks of Evaluator Source of granules: Vision Pharmaceuticals, Islamabad.
Decision: Approved with innovator’s specification.Manufacturing requirements for diluents for

reconstitution of product shall be discussed in Registration board
Brand Name +Dosage Form + Strength SKINIDE DRY POWDER SUSPENSION 100 mg/5ml
Composition Each 5ml Contain:
Nitazoxanide….100mg
Pharmacological Group Antibiotic/Antiprotozoal
Type of Form Form-5
Approval status of product in Reference Alinia by Romark (USFDA Approved)
Me-too status Diatazox 100mg/5ml Dry Suspension of M/s S.J & G
Brand Name +Dosage Form + Strength SKICON DRY POWDER SUSPENSION 50 mg/5ml
Fluconazole ………....50mg
Pharmacological Group Anti-mycotic
Type of Form Form-5
Approval status of product in Reference Diflucan 10 mg/ml powder for oral suspension by M/s
Regulatory Authorities. Pfizer Limited (MHRA approved)
Me-too status Diflucan 50mg/5ml dry suspension by M/s Pfizer
(Reg#013608)
Remarks of Evaluator Official monograph is available in USP pharmacopiea
Brand Name +Dosage Form + Strength SKIZOL DRY POWDER SUSPENSION 100 mg/5ml
Linezolid………100mg
Pharmacological Group Protein Synthesis inhibitor
Type of Form Form-5
Approval status of product in Reference Zyvox 100 mg/5ml Granules For Oral Suspension By M/S
Regulatory Authorities. Pharmacia Limited, (USFDA)
Me-too status Linzol 100mg /5ml oral dry suspension of M/s Regal
Pharmaceuticals
Decision: Registration Board approved the applied formulation with innovator’s specifications
in the light of decision taken in 271st meeting, stated as under:
FOR LINEZOLID
decided as under;
innovator of the product i.e M/s Pfizer which has clearly mention the storage
precautions in its Product Information Leaflet (PIL). They will also make sure that the
solution is kept correctly in its box and foil wrapping in order to protect from light.”
Brand Name +Dosage Form + Strength SKITHROX DRY POWDER SUSPENSION
200+600 mg/5 ml
Erythromycin (as ethylsuccinate)………200mg
Sulfisoxazole (as acetyl)………………..600mg
Pharmacological Group Antibiotic,systemic
Type of Form Form-5
Approval status of product in Reference Pediazole dry powder suspension Ross Labs
Regulatory Authorities. (FDA approved)
Me-too status Pediazole dry powder suspension by M/s Abbott
Decision: Approved.
Tablet General
722. Name and address of manufacturer / M/S Skims Pharmaceuticals, 10/B Value Addition City,
Brand Name +Dosage Form + Strength SKICIN TABLETS 250 mg
Composition Each Film Coated tablet contains:
Ciprofloxacin as HCl………..250 mg
Type of Form Form-5
Approval status of product in Reference Cipro 250mg Tablet by M/s Bayer Health Care
Regulatory Authorities. Pharmaceuticals Inc.USA & Germany (USFDA
Approved)
Me-too status Mercip 250mg tablet by M/s Merck (Reg#024601)
Decision: Approved.
Diary No. Date of R& I & fee Dy.No; 6349. Date:20-02-18 , Rs.20,000/-
Type of Form Form-5
Approval status of product in Reference Cipro 500mg Tablet by M/s Bayer Health Care
Regulatory Authorities. Pharmaceuticals Inc.USA & Germany (USFDA
Approved)
Me-too status Mercip 500mg Tablet by M/s Merck (Reg#024602)
Decision: Approved.
Type of Form Form-5
Approval status of product in Reference Ciproxin 750mg Tablet by M/s Bayer Pharmaceuticals
Me-too status Ciprox 750mg Tablet by M/s Amson
Decision: Approved.
Brand Name +Dosage Form + Strength VOFLOX TABLETS 250 mg
Levofloxacin as (hemihydrate)………..250 mg
Type of Form Form-5
Approval status of product in Reference Evoxil 250 mg film-coated tablets by M/s Beacon Pharm
Me-too status Leoflox 250mg Tablet by M/s Bryon Pharma
Decision:Approved.
Brand Name +Dosage Form + Strength VOFLOX TABLETS 500 mg
Levofloxacin as (hemihydrate)………..500 mg
Type of Form Form-5
Me-too status Leoflox 250mg Tablet by M/s Bryon Pharma
Decision:Approved.
Brand Name +Dosage Form + Strength SKIFENAC TABLETS 50 mg
Composition Each Enteric Coated tablet contains:
Diclofenac Sodium………..50 mg
Type of Form Form-5
Approval status of product in Reference Diclofenac Sodium 50 mg Gastro-resistant Tablets of
Regulatory Authorities. USFDA approved
Me-too status Vorenac 50mg of M/s Mission Karachi (Reg.#080324)
Decision:Approved.
Brand Name +Dosage Form + Strength SKIFENAC SR TABLETS 100 mg
Composition Each sustained release film coated tablet contains:
Diclofenac sodium………100mg
Pharmacological Group Analgesic, anti-inflammatory and anti-rheumatic agent
Type of Form Form-5
Approval status of product in Reference Voltarol Retard Tablets 100mg of MHRA approved
Me-too status Ufenac-SR 100mg Tablets of M/s Valor Pharmaceuticals
Decision: Approved.
Brand Name +Dosage Form + Strength SKIKAST TABLETS 4 mg
Montelukast sodium equivalent to Montelukast…4 mg
Type of Form Form-5
Approval status of product in Reference Singulair By M/S. Merck, of USFDA approved
Me-too status Montef 4mg chewable tablets of M/s Efroz pharma
Remarks of Evaluator Official monograph is present in USP
Montelukast sodium equivalent to Montelukast…5mg
Pharmacological Group Anti-asthmatic, Leukotriene receptor antagonist.
Type of Form Form-5
Me-too status Montef 5mg chewable tablets of M/s Efroz pharma
Montelukast sodium equivalent to Montelukast…10 mg
Diary No. Date of R& I & fee Dy.No;6358. Date:20-02-18 , Rs.20,000/-
Type of Form Form-5
Me-too status Montef 10mg tablets of M/s Efroz pharma
Brand Name +Dosage Form + Strength SKIFAM TABLETS 20 mg
Famotidine….…20 mg
Pharmacological Group Antacids/Anti-flatulents/Anti-peptic ulcerants
Type of Form Form-5
Approval status of product in Reference Pepcid 20mg tablet (Approved by USFDA)
Me-too status Antidine 20mg Tablet of Mediate Pharmaceuticals
Decision:Approved
Brand Name +Dosage Form + Strength SKIFAM TABLETS 40 mg
Famotidine….…40 mg
Pharmacological roup Antacids/Anti-flatulents/Anti-peptic ulcerants
Type of Form Form-5
Approval status of product in Reference Pepcid 40mg tablet (Approved by USFDA)
Me-too status Antidine 40mg Tablet of Mediate Pharmaceuticals
Decision:Approved.
Brand Name +Dosage Form + Strength SKIGESIC TABLETS
Paracetamol……..450 mg
Orphenadrine…..35 mg
Diary No. Date of R& I & fee Dy.No6353 Date:20-02-18 , Rs.20,000/-
Pharmacological Group Analgesic, anti-pyretics, muscle relaxant
Type of Form Form-5
Approval status of product in Reference Norgesic by M/s iNova Pharmaceuticals, Australia(TGA)
Me-too status SIC Tablets of M/s Shrooq Pharmaceuticals
Brand Name +Dosage Form + Strength DOLBY TABLETS
Composition Each Tablet Contain:
Piroxicam (as Beta-Cyclodextrin) …..20mg
Type of Form Form-5
Pack size & Demanded Price 2 x 10‘s & As per SRO
Approval status of product in Reference Cycladol 20 mg Tablets of ( ANSM approved)
Me-too status Betacare 20 mg Tablet by M/s CSH Pharma
(Reg#047740)
Brand Name +Dosage Form + Strength EVOCIN TABLETS
Levocetirizine dihydrochloride……..5mg
Pharmacological Group Anti-Histamine
Type of Form Form-5
Approval status of product in Reference Levocetirizine tablets by Actavis (MHRA Approved)
Me-too status Invocet tablet by Aries Pharma
Brand Name +Dosage Form + Strength SKIMOX TABLETS
Composition Each film coated tablet contains;
Moxifloxacin (as hydrochloride)...400mg
Type of Form Form-5
Pack size & Demanded Price 1x5‘s & As per SRO
Approval status of product in Reference Avelox 400 mg film-coated tablets by M/s Bayer plc,
Me-too status Moxox 400mg of M/s Wellborne Pharmachem
and Biologicals

Brand Name +Dosage Form + Strength SKILID TABLETS
Nimesulide …..100 mg
Pharmacological Group Anti-inflammatory, anti-rheumatic agents, non-steroids
Type of Form Form-5
Approval status of product in Reference Approved by EMA
Me-too status Nimside Tablets 100mg.of M/s Novamed Pharmaceuticals
Evaluator PEC-VII
12. M/s Sayyed Pharmaceutical Industries (Pvt) Ltd. Plot No. 67/2, Phase III, Industrial
Estate, Hattar, Pakistan ( New Section)
CLB in its 257th meeting held on 24-25th January, 2018 has considered and granted the following 3 (03)
additional section of M/ s Sayyed Pharmaceutical Industries (Pvt) Ltd.

1 Dry Powder injection 27 10
Cephalosporin
2 Sachet (General) section 11 10
3 Stores (Finished good packing
material, liquid and product
recall
Sachet Section (General)
739. Name and address of Manufacturer / M/s Sayyed Pharmaceutical Industries (Pvt) Ltd. Plot
Applicant No. 67/2, Phase III, Industrial Estate, Hattar, Pakistan.
Brand Name+DosageForm+Strength Syderine Sachet
Composition Each Sachet contains
Mebeverine HCl…..135mg
Ispaghula husk…..3.5g
Diary No. Date of R&I & fee Diary No: 8358, 6-3-18, Rs: 20,000/-
Pharmacological Group Antispasmodic
Type of Form Form-5
Pack Size & Demanded Price 10‘s Sachet /As per SRO
Approval status of product in Reference Fybogel Mebeverine (MHRA approved)
Me-too status Colospas fibro by Nabiqasim
GMP status Panel inspection on 05-01-2018.Panel recommended
grant of additional section.
Brand Name +Dosage Form + Strength Ostrium Sachet
Diary No. Date of R& I & fee Diary No:8357,6-3-18, Rs: 20,000/-
Strontium ranelate….2mg
Pharmacological Group Anti-osteoporotic

Type of Form Form-5
Pack size & Demanded Price 7‘s Sachet /As per SRO
Approval status of product in Reference Strontium ranelate 2 g granules for oral suspension by
Regulatory Authorities. M/s Rivopharm UK Ltd. (MHRA approved)
Me-too status Onita 2g powder by M/s PharmEvo. (Reg# 057746)
Brand Name+DosageForm+Strength Ferimax Sachet
Fosfomycin tromethamine…….3g
Type of Form Form-5
Finished Product Specification Manufacturer Specs
Approval status of product in Reference MONUROL USFDA approved.
Me-too status Monurol by M/S Scharper
Brand Name +Dosage Form + Strength Saydocit Sachet
Diary No. Date of R& I & fee Diary No:8356, 6-3-18, Rs: 20,000/-
Sodium bicarbonate….0.428g/g
Citric acid……0.176g/g
Sodium citrate……..0.153g/g
Tartaric acid….0.215g/g
Pharmacological Group Antacid
Type of Form Form-5
Pack size & Demanded Price 20‘s/100's Sachet /As per SRO
Me-too status Citro soda by Abbott

Remarks of Evaluator Approval status of product in Reference Regulatory
Decision:
Brand Name+DosageForm+Strength SPEEDO Sachet
Macrogol 3350…..13.125g
Sodium Chloride….0.3507g
Sodium bicarbonate……0.1785g
Potasium Chloride……0.0466g
Pharmacological Group Laxative electrolytes
Type of Form Form-5
Approval status of product in Reference Movicol 13.8g sachet, powder for oral solution by
Regulatory Authorities M/s Norgine Limited (MHRA Approved)
Me-too status Movopeg Sachet by M/s Wns field Pharmaceutical

(Reg#078594)
Decision:
Brand Name +Dosage Form + Strength Testin Sachet
Acetylcysteine……200mg
Pharmacological Group Antacid
Type of Form Form-5
Approval status of product in Reference Acetylcysteine 200 mg Powder for Oral Solution by
Regulatory Authorities. M/s NTC S.r.l. (MHRA approved)
Me-too status Mucolator 200mg powders by M/s Abbott
Laboratories. (Reg# 017693)
Decision:
Brand Name +Dosage Form + Strength Sydrol insta 40mg Sachet
Omeprazole…..40mg
Sodium bicarbonate….1680mg
Pharmacological Group PPI/Antacid
Type of Form Form-5
Approval status of product in Reference Zegerid (USFDA Approved) Powder for oral
Regulatory Authorities. suspension
Me-too status Risek Insta 40mg by Getz
Decision:
Brand Name +Dosage Form + Strength OREO Sachet
Glucose anhydrous….13.5g
Sodium citrate……….2.9g
Sodium Chloride…….2.6g
Potasium chloride….1.5g
Pharmacological Group Oral rehydration salt
Type of Form Form-5
Approval status of product in Reference Oral Rehydration Salts (ORS) of Anisons
Regulatory Authorities. International Ltd, UK (WHO & UNICEF Approved)
Me-too status Dextrosol by P.D.H. Pharma
Decision: Approved.
Brand Name +Dosage Form + Strength Magfine Sachet
Dioctahedral smectite…. 3g
Type of Form Form-5
Approval status of product in Reference DIOSMECTITE MYLAN 3 g by M/s OY SIMCERE
Regulatory Authorities. EUROPE LTD, ANSM France Approved
Me-too status Nexdrol 3gm Schaet by M/s Nexus Pharma (Reg #
081590).
Brand Name +Dosage Form + Strength Sydrol insta 20mg Sachet
Omeprazole…..20mg
Sodium bicarbonate….1680mg
Type of Form Form-5
Approval status of product in Reference Zegerid (USFDA Approved) Powder for oral
Regulatory Authorities. suspension
Me-too status Risek Insta 20 mg by Getz
Decision: Approved.
Brand Name +Dosage Form + Strength Sydokast 4 mg
Montulokast sodium…. 4 mg
Pharmacological Group Leukotriene inhibitor
Type of Form Form-5
Approval status of product in Reference Singulair Paediatric 4 Mg Granules by M/s Merck
Regulatory Authorities. Sharp & Dohme Ltd.(MHRA approved)
Me-too status Singulair 4mg powder by M/s OBS (Reg# 031377)
Decision: Approved.
Evaluator-PEC-VIII
13. M/s Sayyed Pharmaceutical Industries (Pvt) Ltd. Hattar. ( New Section)
CLB in its 257th meeting held on 24-25th January, 2018 has considered and granted approval of the following two
(02) additional section of M/ s Sayyed Pharmaceutical Industries (PVT) Ltd.
Dry Powder Injection(Cephalosporin) Section
27 Products/10 Molecules
759. Name and address of manufacturer / M/s Sayyed Pharmaceutical Industries (Pvt) Ltd.
Applicant Plot No. 67/2, Phase III, Industrial Estate, Hattar, Pakistan.
Brand Name +Dosage Form + Strength Sayxone 250mg IV Injection
Diary No. Date of R& I & fee Diary No: 8326: 06-03-18; Rs: 20,000/-
Composition Each Vial contains
Ceftriaxone (as Sodium)…. 250mg
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Pack size & Demanded Price 1‘s Vial /As per SRO
Approval status of product in Reference Rocephin 250 mg of Roche Products Ltd. UK (MHRA)
Me-too status Hytrex 250 mg Injection IV of Hygeia Pharmaceuticals.
GMP status Panel inspection on 05-01-2018 recommended grant of
additional section.
Decision: Approved.
Brand Name +Dosage Form + Strength Sayxone 500mg IV Injection
Ceftriaxone (as sodium)…. 500mg
Type of Form Form-5
Me-too status Signum 500mg Injection IV of Cherwel pharmaceuticals.
additional section.
Decision: Approved.
Brand Name +Dosage Form + Strength Sayxone 1g IV Injection
Ceftriaxone (as sodium)…. 1g
Type of Form Form-5
Approval status of product in Reference Rocephin 1 g of Roche Products Ltd. UK (MHRA)
Me-too status Rocephin 1 g I.V by Roche (Pak) Ltd.
additional section.
Decision: Approved.
Brand Name +Dosage Form + Strength Sayxone 2g IV Injection
Ceftriaxone (as sodium)…. 2g
Type of Form Form-5
Approval status of product in Reference Rocephin 2 g of Roche Products Ltd. UK (MHRA)
Me-too status Welcef Injection 2g IV Of Welwrd Pharmaceuticals
additional section.
Decision: Approved.
Brand Name +Dosage Form + Strength Sayxone 250mg IM Injection
Type of Form Form-5
Me-too status Abex 250mg Injection IM of Semos Pharma
GMP status Panel inspection conducted on 05-01-2018 recommended
Decision: Approved.
Brand Name +Dosage Form + Strength Sayxone 500mg IM Injection
Type of Form Form-5
Me-too status El-cef 500mg Injection IM of linear Pharma
GMP status Panel inspection conducted on 05-01-2018 recommended
Decision: Approved.
Brand Name +Dosage Form + Strength Sayxone 1g IM Injection
Ceftriaxone (as Sodium)…. 1g
Type of Form Form-5
Me-too status Cefaben 1gm Injection of Imco Pharmaceutical
GMP status Panel inspection on 05-01-2018.Panel recommended grant of
additional section.
Decision: Approved.
Brand Name +Dosage Form + Strength Toxim 250mg IM/IV Injection
Cefotaxime (as sodium)…. 250mg
Type of Form Form-5
Approval status of product in Reference Claforan 250 mg of Aventis Pharma, UK (MHRA)
Me-too status Fotax 250mg Injection of Cirin Pharmaceuticals.
additional section.
Decision: Approved.
Brand Name +Dosage Form + Strength Toxim 500mg IM/IV Injection
Cefotaxime (as sodium)…. 500mg
Type of Form Form-5
Approval status of product in Reference Claforan 500 mg of Aventis Pharma, UK (MHRA)
Me-too status Fotax 500mg Injection of Cirin Pharmaceuticals.
additional section.
Decision: Approved.
Brand Name +Dosage Form + Strength Toxim 1g IM/IV Injection
Cefotaxime (as Sodium)…. 1g
Type of Form Form-5
Me-too status Fotax 1g Injection of Cirin Pharmaceuticals.
additional section.
Decision: Approved.
Brand Name +Dosage Form + Strength Toxim 2g IV Injection
Cefotaxime (as sodium)…. 2g
Type of Form Form-5
Approval status of product in Reference Claforan 2 g of Aventis Pharma, UK (MHRA)
Me-too status Kalfoxim injection 2g vial (imported registered product in
the name of progressive associates Karachi)
additional section.
Remarks of the Evaluator. Evidence of intramuscular use of applied strength is required.
Decision: Approved with Intravenous Route of administration only.
Brand Name +Dosage Form + Strength Saypime 500mg IM/IV Injection
Cefepime (as hydrochloride)…. 500mg
Type of Form Form-5
Approval status of product in Reference Maxipime 500 mg of Hospira Inc., USA (USFDA)
Me-too status Nuxipim 500mg Injection of Bosch.
additional section.
Decision: Approved.
Brand Name +Dosage Form + Strength Saypime 1g IM/IV Injection
Cefepime (as hydrochloride)…. 1g
Type of Form Form-5
Approval status of product in Reference Maxipime 1 g of Hospira Inc., USA (USFDA)
Me-too status Nuxipim 1g Injection of Bosch
additional section.
Decision: Approved.
Brand Name +Dosage Form + Strength Saypime 2g IM/IV Injection
Cefepime (as hydrochloride)…. 2g
Type of Form Form-5
Approval status of product in Reference Maxipime 2 g of Hospira Inc., USA (USFDA)
Me-too status Medipime 2 g by Mediceena
additional section.
Decision: Approved.
Brand Name +Dosage Form + Strength Sulbacta 500mg IM/IV Injection
Cefoperazone (as Sodium)…. 250mg
Sulbactam (as Sodium)……….250mg
Type of Form Form-5
Approval status of product in Reference EMA approved. (as provided by the firm)
Me-too status Cebac by Bosch
additional section.
Remarks of the Evaluator. ● Evidence approval of applied formulation in any
other reference regulatory authorities/agencies which
were declared/approved by the Registration Board in
its 275th meeting.
● Mention type of primary packaging material of
● Applicant has claimed manufacture specification and
the applied formulation is present in Japan
pharmacopoeia.
Decision: Deferred for the following:
● Evidence approval of applied formulation in any other reference regulatory
meeting as the provided evidence is not verifiable.
● Type of primary packaging material of applied formulation.
Brand Name +Dosage Form + Strength Sulbacta 1g IM/IV Injection
Cefoperazone (as Sodium)…. 500mg
Sulbactam (as Sodium)……….500mg
Type of Form Form-5
Approval status of product in Reference Approved in PMDA
Me-too status Keftime 1 g Injection of Cirin pharmaceutical
additional section.
Remarks of the Evaluator. Applicant has claimed manufacture specification and the
applied formulation is present in Japan pharmacopoeia.
Decision: Approved with Japan Pharmacopoeia specifications.
Brand Name +Dosage Form + Strength Sulbacta 2g IM/IV Injection
Cefoperazone (as Sodium)…. 1g
Sulbactam (as Sodium)……….1g
Type of Form Form-5
Approval status of product in Reference Approved in three European Union countries.
Me-too status Cefbactum 2g injection of Global pharmaceuticals.
additional section.
Remarks of the Evaluator. Applicant has claimed manufacture specification and the
applied formulation is present in Japan pharmacopoeia
Evidence of intramuscular use of applied strength.
Decision: Approved with Japan Pharmacopoeia specifications.
Brand Name +Dosage Form + Strength Synide 500mg IM/IV Injection
Ceforanide…. 500mg
Type of Form Form-5
Approval status of product in Reference US-FDA Approved. (but discontinued)
Me-too status Fornid Injection 500mg of M/s Fynk Pharmaceuticals,
additional section.
Remarks of the Evaluator ● Evidence approval of applied formulation in any
its 275th meeting.
Decision: Deferred for the following:
meeting as applied formulation is discontinued in US-FDA.
Brand Name +Dosage Form + Strength Ceftazid 250mg IM/IV Injection
Ceftazidime (as pentahydrate)…. 250mg
Type of Form Form-5
Approval status of product in Reference Fortum 250 mg of GSK Ltd. UK (MHRA)
Me-too status Vegazid 250mg Injection of Vega Pharmaceuticals
additional section.
Decision: Approved.
Brand Name +Dosage Form + Strength Ceftazid 500mg IM/IV Injection
Ceftazidime (as Pentahydrate)…. 500mg
Type of Form Form-5
Approval status of product in Reference Fortum 500 mg of GSK Ltd. UK (MHRA)
Me-too status Vegazid 500mg Injection of Vega Pharmaceuticals.
additional section.
Decision: Approved.
Brand Name +Dosage Form + Strength Ceftazid 1g IM/IV Injection
Ceftazidime (as Pentahydrate)…. 1g
Type of Form Form-5
Approval status of product in Reference Fortum 1 g of GSK Ltd. UK (MHRA)
Me-too status Vegazid 1gm Injection of Vega Pharmaceuticals.
additional section.
Decision: Approved.
Brand Name +Dosage Form + Strength Sayfruxime 250mg IM/IV Injection
Cefuroxime(as sodium)……….250mg
Type of Form Form-5
Approval status of product in Reference Zinacef 250 mg of GSK Ltd., UK (MHRA)
Me-too status Rubect 250mg injection IV of Silver Oak
additional section.
Decision: Approved.
Brand Name +Dosage Form + Strength Sayfruxime 500mg IM/IV Injection
Cefuroxime(as sodium)……….500mg
Type of Form Form-5
Approval status of product in Reference USFDA approved. (as provided by the firm)
Me-too status Optik 500mg Injection by M/s Wilshire (Reg No.
071388)
additional section.
its 275th meeting.
Decision:
Deferred for the following:
meeting as the provided evidence is not verifiable.
Brand Name +Dosage Form + Strength Sayfruxime 1.5g IM/IV Injection
Cefuroxime(as sodium)……….1.5g
Type of Form Form-5
Approval status of product in Reference Zinacef 1.5 g of GSK Ltd., UK (MHRA)
Me-too status Rubect 1.5mg injection IV of Silver Oak
additional section.
Remarks of the Evaluator. Intramuscular injections should be injected well within the
bulk of a relatively large
muscle and not more than 750 mg should be injected at one
site. For doses greater
than 1.5 g intravenous administration should be used.
Decision: Approved.
Brand Name +Dosage Form + Strength Zocil 250mg IM/IV Injection
Cefazolin (as Sodium)…. 250mg
Type of Form Form-5
Approval status of product in Reference USFDA approved. (but discontinued)
Me-too status Safelin Injection 250 mg of Fassgen Pharmaceuticals
additional section.
its 275th meeting.
Decision:
Deferred for the following:
meeting as applied formulation is discontinued in US-FDA.
Brand Name +Dosage Form + Strength Zocil 500mg IM/IV Injection
Cefazolin (as Sodium)…. 500mg
Type of Form Form-5
Me-too status Lincef injection 500 mg of Lowit Pharma
additional section.
Decision: Approved.
Brand Name +Dosage Form + Strength Zocil 1g IM/IV Injection
Cefazolin (as Sodium)…. 1g
Type of Form Form-5
Me-too status Lincef injection 1g of Lowit Pharma
additional section.
Decision: Approved.
Evaluator PEC-III
14. M/s Honig Pharmaceuticals, Rawalpindi

Following two additional sections of M/s Honig Pharmaceutical Laboratories 14 KM Adyala Road
Rawalpindi have been approved by Central licensing Board in its 257 th meeting. The letter for grant of
additional sections was issued to the firm on 21st February 2018.
1. Capsule section (General)

2. Oral dry powder suspension (General)
Now the firm has applied for following
1 Capsule section (General) 18 10
2 Oral dry powder suspension (General)
Capsule section (General): Products-18, Molecules-10

786. Name and address of manufacturer / M/s Honig Pharmaceutical Laboratories 14 KM
Applicant Adyala Road Rawalpindi
Brand Name +Dosage Form + Strength Azonic 250mg Capsule
PKR 20,000/-: 26-1-2018
Azithromycin (as dihydrate)……….250mg
Type of Form Form 5
Pack size & Demanded Price 6‘s, 10‘s, 12‘s: As per SRO
Approval status of product in Reference Zithromax 250mg capsule by Pfizer
Me-too status Azomax capsule by Sandoz
GMP status New section granted: 24-25th January 2018.
Decision:
Approved.
Brand Name +Dosage Form + Strength Azonic 500mg Capsule
PKR 20,000/-: 26-1-2018
Azithromycin (as dihydrate)……….500mg
Type of Form Form 5
Pack size & Demanded Price 3‘s, 5‘s, 6‘s, 10‘s, 12‘s: As per SRO
Me-too status Azithromycin 500mg capsule by Unipharma
Remarks of the Evaluator. ● Evidence of approval of applied formulation in
reference regulatory authorities which were approved
by Registration Board in its 275th meeting could not
be confirmed.
Decision:
Brand Name +Dosage Form + Strength Gaba 50mg Capsule
PKR 20,000/-: 26-1-2018
Pregabalin……….50mg
Pharmacological Group Anticonvulsant
Type of Form Form 5
Finished Product Specification Firm has claimed in house specification
Approval status of product in Reference Lyrica by PF Prism
Me-too status Gabica by Getz Pharma
Decision:
Brand Name +Dosage Form + Strength Gaba 75mg Capsule
PKR 20,000/-: 26-1-2018
Type of Form Form 5
Decision:
Brand Name +Dosage Form + Strength Gaba 100 mg Capsule
PKR 20,000/-: 26-1-2018
Type of Form Form 5
Decision:
Brand Name +Dosage Form + Strength Colchi Capsule
PKR 20,000/-: 26-1-2018
Thiocolchicoside………4mg
Pharmacological Group Skeletal muscle relaxant
Type of Form Form 5
Pack size & Demanded Price 2 x 10‘s: As per SRO
Approval status of product in Reference MYOPLEGE 4 mg hard capsule of M/s GENEVRIER
Regulatory Authorities. (ANSM France Approved)
Me-too status Myogen Capsules 4 mg by M/s Nimrall
Pharmaceuticals
Decision:
Brand Name +Dosage Form + Strength Flod 150mg Capsule
PKR 20,000/-: 26-1-2018
Fluconazole……150mg
Type of Form Form 5
Finished Product Specification JP Specifications
Pack size & Demanded Price 1‘s, 4‘s: As per SRO
Approval status of product in Reference Diflucan capsule by Pfizer
Me-too status Diflucan capsule by Pfizer
Decision:
Approved.
Brand Name +Dosage Form + Strength Ergocid 100mg capsule
PKR 20,000/-: 26-1-2018
Itraconazole (IR Pellets)……..100mg
Type of Form Form 5
Approval status of product in Reference Sporanox capsule by Jansen
Me-too status Itrax capsule by Ferozesons
Remarks of the Evaluator. Source of pellets: M/s Vision Pharmaceuticals,
Islamabad
Decision:
Brand Name +Dosage Form + Strength Seronin 20mg Capsule
PKR 20,000/-: 26-1-2018
Fluoxetine (as hydrochloride)………20mg
Type of Form Form 5
Approval status of product in Reference Olena 20mg capsule by Medreich Plc
Me-too status Prozac capsule by Eli Lilly
Decision:
Approved.
Brand Name +Dosage Form + Strength Dulox Capsule 20mg
PKR 20,000/-: 26-1-2018
Duloxetine as hydrochloride (enteric coated
pellets)…..20mg
Type of Form Form 5
Approval status of product in Reference Duloxetine 20mg capsule by Teva UK
Me-too status Simba capsule by Shrooq Pharma
Islamabad.
Decision:
Approved.
PKR 20,000/-: 26-1-2018
pellets)…..30mg
Type of Form Form 5
Pack size & Demanded Price 10‘s, 14‘s: As per SRO
Islamabad.
Decision:
Approved.
PKR 20,000/-: 26-1-2018
pellets)…..60mg
Type of Form Form 5
Pack size & Demanded Price 1 x 10‘s, 1 x14‘s, 2 x 14‘s: As per SRO
Islamabad.
Decision:
Approved.
Brand Name +Dosage Form + Strength Xamp Capsule 20mg
PKR 20,000/-: 26-1-2018
Esomeprazole magnesium dihydrate (enteric coated
pellets) equivalent to esomeprazole……20mg
Type of Form Form 5
Pack size & Demanded Price 2 x7‘s. 1 x 10‘s, 1 x 14‘s, 2 x 10‘s: As per SRO
Approval status of product in Reference Emozul capsule by Consilient Healthcare
Me-too status Nexum capsule by Getz Pharma
Islamabad.
Decision:
Approved.
Brand Name +Dosage Form + Strength Xamp Capsule 40mg
PKR 20,000/-: 26-1-2018
Esomeprazole magnesium dihydrate (enteric coated
pellets) equivalent to esomeprazole……40mg
Type of Form Form 5
Pack size & Demanded Price 2 x7‘s. 1 x 14‘s, 2 x 5‘s: As per SRO
Approval status of product in Reference Emozul capsule by Consilient Healthcare
Me-too status Nexum capsule by Getz Pharma
Islamabad.
Decision:
Approved.
Brand Name +Dosage Form + Strength Sec Capsule 20mg
PKR 20,000/-: 26-1-2018
Omeprazole (enteric coated pellets) .……20mg
Type of Form Form 5
Pack size & Demanded Price 1 x 14‘s, 2 x 7‘s, 1 x 10‘s: As per SRO
Approval status of product in Reference Losec Capsule by Astra Zaneca
Me-too status Losec Capsule by Astra Pharma
Islamabad.
Decision:
Approved.
Brand Name +Dosage Form + Strength Sec Capsule 40mg
PKR 20,000/-: 26-1-2018
Omeprazole (enteric coated pellets) .……40mg
Type of Form Form 5
Approval status of product in Reference Losec Capsule by Astra Zaneca
Me-too status Losec Capsule by Astra Pharma
Islamabad.
Decision:
Approved.
Brand Name +Dosage Form + Strength Oryl Capsule 60mg
PKR 20,000/-: 26-1-2018
Orlistat (IR pellets)………..60mg
Pharmacological Group Lipase Inhibitor
Type of Form Form 5
Pack size & Demanded Price 1 x 10‘s, 3 x 10‘s: As per SRO
Approval status of product in Reference Beacita capsule by Actavis
Me-too status Orslim capsule by Pharmevo
Islamabad.
Decision:
Approved.
Brand Name +Dosage Form + Strength Oryl Capsule 120mg
PKR 20,000/-: 26-1-2018
Orlistat (IR pellets)………..120mg
Type of Form Form 5
Approval status of product in Reference Beacita capsule by Actavis
Me-too status Orslim capsule by Pharmevo
Islamabad.
Decision:
Approved.
Evaluator PEC-IV
Dry Powder Suspension Section

804. Name and address of manufacturer / M/S Honig Pharmaceuticals Laboratories, 14Km, Adyala
Applicant Road, Rawalpindi.
Brand Name +Dosage Form + Strength AZONIC DRY SUSPENSION 200 mg/5ml
Diary No. Date of R& I & fee Dy. No; 4169 Date:02-02-18 , Rs.20,000/-
Type of Form Form-5
Pack size & Demanded Price 15 ml & 25ml As per SRO
Approval status of product in Reference Zithromax Powder for Oral Suspension 200mg/5ml by
Regulatory Authorities. M/s Pfizer Limited, MHRA approved
Decision: Approved.
Brand Name +Dosage Form + Strength HOMYCIN DRY SUSPENSION 125 mg/5 ml
Clarithromycin ……….125mg
Type of Form Form-5
Regulatory Authorities. Abbvie, USFDA approved.
Pharmaceuticals
Remarks of Evaluator ● Clarithromycin in taste masked granules form
must be signed but firm is using in powder
form.Please clarify
Decision: Deferred for source of pellets, along with stability studies data, GMP certificate of
supplier and differential fee in case of import of pellets.
Brand Name +Dosage Form + Strength HOMYCIN DRY SUSPENSION
250 mg/5 ml
Clarithromycin ……….250mg
Type of Form Form-5
Regulatory Authorities. Abbvie, USFDA approved
Me-too status Wintek DS 250mg /5ml Dry Suspension by M/s
Winthrox
Remarks of Evaluator Clarithromycin in taste masked granules form
must be signed but firm is using in powder
form.Please clarify
Brand Name +Dosage Form + Strength ARTINIC DS DRY SUSPENSION
Artemether….15mg
Type of Form Form-5
Approval status of product in Reference WHO Approved Formulation
Me-too status Astin Dry Suspension 15/90mg by M/s MBL
Decision: Approved
Brand Name +Dosage Form + Strength HODINE DRY SUSPENSION 40 mg/5ml
Composition Each 5 ml (after reconstitution) contains:
Famotidine ..........40 mg
Pharmacological Group H2-receptor antagonist
Type of Form Form-5
Approval status of product in Reference Pepcid of 40mg/5mL (USFDA approved)
Me-too status Zepsin 40mg/5ml Suspension of Cirin Pharmaceuticals
Remarks of Evaluator Firm changed the formulation from 10mg/ 5mL to
40mg/5ml as 10mg/5mL could not be traced in SRA
Brand Name +Dosage Form + Strength FLOD DRY SUSPENSION 50 mg/5ml
Fluconazole ………....50mg
Pharmacological Group Anti-mycotic
Type of Form Form-5
Approval status of product in Reference Diflucan 10 mg/ml powder for oral suspension by M/s
Regulatory Authorities. Pfizer Limited (MHRA approved)
Me-too status Diflucan 50mg/5ml dry suspension by M/s Pfizer
(Reg#013608)
Remarks of Evaluator Official monograph is available in USP pharmacopiea
Brand Name +Dosage Form + Strength HOZID DRY SUSPENSION 100 mg/5ml
Linezolid………100mg
Pharmacological Group Protein Synthesis inhibitor
Type of Form Form-5
Approval status of product in Reference Zyvox 100 mg/5ml Granules For Oral Suspension By M/S
Regulatory Authorities. Pharmacia Limited, (USFDA)
Me-too status Linzol 100mg /5ml oral dry suspension of M/s Regal
Pharmaceuticals
FOR LINEZOLID
decided as under;
Brand Name +Dosage Form + Strength HEVEZOLE DRY SUSPENSION 200 mg/5ml
Voriconazole………200mg
Pharmacological Group Anti fungal
Type of Form Form-5
Approval status of product in Reference VFEND 200 mg/5ml Oral Suspension of (USFDA
Me-too status Vorif Dry Suspension of M/s Ferozsons Labs
Case No. 05 Registration applications of newly granted DML or New section (Human):
a. Deferred cases
Evaluator PEC-III
812. Name and address of manufacturer / Idcot Pharmaceuticals P-6/A, Pharmaceutical zone, M-3,
Applicant Industrial City, Faisalabad
Brand Name +Dosage Form + Strength Bandocracy
Surgical Dressing
Diary No. Date of R& I & fee Dy No. 2916 : 12-04-2017
PKR 20,000/- : 11-04-2017
Composition Sodim Fusinate B.P. 2% w/w
Ointment Base
Cotton & Viscose Yarn, Threads per 10cm: Wrap, Not
less than 74; Weft: Not less than 80
Pharmacological Group Surgical dressing
Type of Form Form 5
Finished Product Specification Firm has claimed BPC
Pack size & Demanded Price
# Cotton Bandage Sizes
1. 5cm x 3m (2‖ x 3m) Pack of dozen
5. 6.5cm x 3m (2.5‖ x 3m) Pack of dozen
9. 7.5cm x 3m (3‖ x 3m) Pack of dozen
Me-too status Steri-Tin Tullem Sufre Tulle by
Cotton Craft (Pvt) Ltd. Lahore
Surgical Fiber Lahore
Leo Pharmaceuticals Karachi
GMP status Last inspection report dated 16-06-2016, panel
recommends the grant of DML by way of formulation
Remarks of the Evaluator. Letter of shortcoming was issued on 9th May 2017 and the
reply received is still deficient in
● Detailed composition, the firm initially provided
composition as Sodim Fusinate B.P. 2% w/w and
ointment Base, now firm has provided new Form-5
stating composition as 100% cotton wool
● Evidence of approval of applied product in
reference regulatory authorities
● Me-too status, firm initially provided reference of
tulle dressing and now provided reference of cotton roll
● Finished product specification
Decision of previous meeting of Deferred for following submissions
Registration Board ● Clarification of detailed composition
● Me-too status
● Finished product specifications (M-270)
Deferred for further deliberation (M-279)
Evaluation by PEC:
Firm has submitted following documents
● Composition: 100% pure cotton
● Me-too status: Surgical Bandage by Cotton Craft Lahore (Reg No: 006272)
● Finished product specification: Claiming white, clean and free from impurities, metallic material,
scale and must meet official BP standard criteria
Decision:
Deferred for confirmation of required manufacturing facility for applied formulation.
Brand Name +Dosage Form + Strength Cottonocracy
Surgical Dressing
PKR 20,000/- : 11-04-2017
Composition As per Specification of BPC
Cottoncracy consists of cotton cloth impregnated with
dried calcium sulphate and suitable adhesive
Pharmacological Group Surgical dressing
Type of Form Form 5
Finished Product Specification Firm has claimed BPC
# Absorbent Cotton Wool Weight
1. 25 gm 1‘s
2. 50 gm 1‘s
3. 75 gm 1‘s
4. 100 gm 1‘s
5. 125 gm 1‘s
6. 150 gm 1‘s
7. 175 gm 1‘s
8. 200 gm 1‘s
9. 250 gm 1‘s
10. 300 gm 1‘s
11. 400 gm 1‘s
12. 500 gm 1‘s
13. 1000 gm 1‘s
Me-too status Ortho Plast by Cotton Craft (Pvt) Ltd. Lahore
Japsona by Rehman Rainbow Lahore
Surgi Plast by BSN Medical (Pvt) Ltd.
● Detailed composition, the firm initially provided
composition as Cottoncracy consists of cotton cloth
impregnated with dried calcium sulphate and suitable
adhesive, now firm has provided new Form-5 stating
composition as 100% cotton bandage
● Me-too status, firm initially provided reference of
ortho plast and now provided reference of white lily by
the same firm
● Me-too status
Evaluation by PEC:
● Composition: Almost pure cellulose, contain 6-7% moisture and 0.1-0.3% ash
● Me-too status: Absorbent cotton wool by Cotton Craft Lahore (Reg No: 006271)
● Finished product specification: Claiming white, clean and free from impurities and must meet
official BP standard criteria
Decision:
Brand Name +Dosage Form + Strength Crepocracy
Surgical Dressing
PKR 20,000/- : 11-04-2017
Composition Yarn count, warp yarn twist, threads/10cm, stretch ability,
breaking load and ph Made from 50% cotton, 41%
polyamide, 9% polyurethane cotton, polyamide and
polyurethane high stretch bandage
Pharmacological Group Surgical Dressing
Type of Form Form 5
Finished Product Specification
# Cotton Crepe Bandage Sizes
1. Medi crepe bandage 7.5cm x 4.5 (3‖) 1‘s
2. Medi crepe bandage 10cm x 4.5m (4‖) 1‘s
3. Medi crepe bandage 15cm x 4.5m (6‖) 1‘s
Me-too status Kohinoor Elastic Crepe Bandage
Elastic cotton crepe bandage
By
Cotton craft (Pvt) Ltd Lahore
Leo Pharmaceutical Karachi
● Composition of surgical dressing
Decision of previous meeting of Deferred for following submissions.
● Me-too status
Evaluation by PEC:
● Composition: Made of cotton, polyester and latex free elastic yarns
● Me-too status: Crepe Bandage by Cotton Craft Lahore (Reg No: 008373)
● Finished product specification: Claiming reusable, non-latex, white, clean and free from
impurities and must meet official BP standard criteria
Decision:
Brand Name +Dosage Form + Strength Gauzocracy
Surgical Dressing
PKR 20,000/- : 11-04-2017
Composition Sodium Fusiate BP 2% w/w
Ointment Base
Cotton & Viscose Yarn, threads per 10cm: Wrap, Not less
than 74: Weft: Not less than 80
Pharmacological Group Surgical Dressing
Type of Form Form 5
Finished Product Specification
# Surgical Gauze Roll Sizes
1. 100cm x 2.5m Roll
2. 100cm x 10m 1‘s
3. 100cm x 20m 1‘s
4. 100cm x 30m
5. 100cm x 40m
6. 100cm x 50m
Me-too status Steri-Tin Tullem Sufre Tulle by
Cotton Craft Lahore
Leo Pharma Karachi
● Composition of surgical dressing
● Me-too status
● Me-too status
Evaluation by PEC:
● Composition: Made of cotton 100%. It is fabric with loose weave used in wounds
● Me-too status: by Cotton Craft Lahore (Reg No: 016659) which could not be confirmed from
database
● Finished product specification: Claiming white, clean and free from impurities, high absorbency
power and must meet official BP standard criteria
Decision:
Evaluator PEC-XII
816. Name and address of manufacturer / M/s Evolution Pharmaceuticals (Pvt.) Ltd.
Applicant Plot #: 25/26, St.#S-3, RCCI, Industrial Estate,
Rawat,Islamabad
Brand Name +Dosage Form + Strength Kenazol Lotion 2% w/w
Ketoconazole…20mg
Pharmacological Group Antifungal for topical use (Imidazole and triazole
derivative)
Type of Form Form 5
Pack size & Demanded Price 60ml/ As per SRO
Approval status of product in Reference Nizoral Anti-Dandruff Shampoo by M/s McNeil Products
Me-too status Ketonaz Lotion by M/s Sante (Reg#073453)
GMP status New License (Inspection Date: 07th June 2017)
Previous remarks of the Evaluator. -
Decision in previous meeting 277th Meeting Registration Board held on 27-29th
December 2017.
Deferred for confirmation of formulation in w/w.
Evaluation by PEC ● Confirmed as w/w formulation in MHRA.
● Firm has also applied in w/w composition.
Decision:
Rawat,Islamabad
Brand Name +Dosage Form + Strength Movate Lotion 0.1% w/w
Mometasone furoate…1mg
Pharmacological Group Corticosteroid, potent (group III)
Type of Form Form 5
Approval status of product in Reference Elocon Scalp Lotion 0.1% w/w by M/s Merck Sharp &
Regulatory Authorities. Dohme (MHRA Approved)
Me-too status Hivate Lotion 0.1% by M/s Saffron (Reg#046430)
December 2017.
Decision:
Registration Board deferred the case in the light of decision of 248th meeting of Registration
Board, for confirmation and verification of segregated dispensing booths, cleaning validation
and controls studies for processes and adequate system to minimize the potential risk of
cross contamination.
Rawat,Islamabad
Brand Name +Dosage Form + Strength Scabimed Lotion 5% w/w
Permethrin…50mg
Pharmacological Group Ectoparasiticides, incl. Scabicides
Type of Form Form 5
Pack size & Demanded Price 60ml, 120ml/ As per SRO
Approval status of product in Reference Permethrin Lotion 5% w/w by M/s GlaxoSmithKline
Regulatory Authorities. Consumer Healthcare (UK) Trading Limited (MHRA
Approved)
Me-too status Permilot Lotion 5% by M/s Semos (Reg#076033)
December, 2017.
Decision:
Rawat,Islamabad
Brand Name +Dosage Form + Strength Betanex Lotion 0.1% w/w
Betamethasone (as valerate) …1mg
Pharmacological Group Corticosteroids, potent (group III)
Type of Form Form 5
Approval status of product in Reference Betnovate Lotion 0.1% w/w by M/s Glaxo Wellcome UK
Me-too status Betnovate Lotion 0.1% by M/s GSK (Reg#000253)
December, 2017.
Decision:
Registration Board deferred the case referreing to the decision of 248th meeting of Registration
Board stating as under:
“Products containing steroidal topical preparations like eye/ear drops, sterile eye ointment,
external preparations i.e. cream/ointment/gel, lotions, spray/aerosols, suppositories, vaginal
preparation, intra oral preparations, nasal drops etc shall be permitted for manufacturing in
general facility/area provided that manufacturers shall have segregated dispensing booths,
cleaning validation and controls studies for processes and adequate system to minimize the
potential risk of cross contamination.”
Registration Board directed the firm to submit clarification regarding confirmation of separate
dispensing booth for applied product.
Rawat,Islamabad
Brand Name +Dosage Form + Strength Terafin Solution 1%w/w
Terbinafine (as hydrochloride) …10mg (1%w/w)
Pharmacological Group Antifungal for topical use
Type of Form Form 5
Approval status of product in Reference Lamisil Once 1% cutaneous solution by M/s
Regulatory Authorities. GlaxoSmithKline Consumer Healthcare (UK) Trading
Limited (MHRA Approved)
Me-too status Lamisil Solution 1% by M/s Sandoz Pak Ltd
(Reg#021173)
December 2017.
Decision:
Applicant Plot No. 31 & 32 Punjab Small Industrial Estate Taxila
Brand Name +Dosage Form + Strength Soscef 250mg/5ml Dry suspension
Composition Each 5ml Reconstituted suspension contains: -
Cephradine…250mg
Diary No. Date of R& I & fee Diary No:2129, 27-10-2016, Rs.20,000/-
Type of Form Form 5
Pack size & Demanded Price 60 and 90ml PET bottle; As per PRC
Approval status of product in Reference Nicef powder for Syrup 250mg/5ml by M/s Strides
Me-too status Biodine Dry Suspension 250mg/5ml by Bio Labs (Reg#
054778)
GMP status Latest inspection report, 22-01-2016, the panel
recommended the grant of GMP certificate
Previous remarks of the Evaluator. -
Decision in previous meeting 269th Meeting Registration Board held on 27-28th April,
2017.
Deferred for submission of latest GMP inspection report
conducted within 1 year
Evaluation by PEC Routine GMP Inspection conducted on 19-10-2017.
The GMP compliance of the firm was good.
Decision:
Approved.
822. Name and address of manufacturer / M/s Kanel Pharmaceuticals.
Applicant Plot # 6-Road Ss-3. National Industrial Zone. Rawat.
Rawalpindi.
Brand Name +Dosage Form + Strength Dompy 10 mg Tablets
Domperidone (as maleate)…10mg
Diary No. Date of R& I & fee Dy No.23; 02-02-2017; Rs. 20000/-
Pharmacological Group Antiemetic
Type of Form Form 5
Pack size & Demanded Price 5 X 10‘s; As per SRO
Me-too status Veldom 10mg Tablet of Well & Well Pharma
GMP status Panel Inspection dated 20-12-2017 recommends renewal
of DML by the way of formulation of following sections.
Tablet section(general)
Capsule section(general )
Previous remarks of the Evaluator. Reference product is approved as Domperidone (as
maleate) …10mg uncoated tablet while firm has applied
with coating.
Decision in previous meeting 278th Meeting of Registration Board held on 29-31st
January 2018.
Deferred for clarification of formulation since reference
product is available as uncoated tablet whereas firm has
applied for film coated tablet
Evaluation by PEC Firm has submitted reference for approval of film coated
tablet in MHRA which was verified.
Motilium 10 mg film-coated tablets by M/s Winthrop
Pharmaceuticals UK Limited (MHRA Approved)
Decision:
Approved.
823. Name and address of manufacturer / M/s Welmed Pharmaceutical Industries (Pvt.) Ltd.
Applicant 108-R-2, Industrial Estate, Gadoon, Swabi.
Brand Name +Dosage Form + Strength Citrowel 4gm Sachet
Tartaric Acid…0.215g
Sodium bicarbonate…0.429g
Citric acid…0.176g
Sodium citrate……0.153g
Pharmacological Group Antacids & Antiflatulents
Type of Form Form 5
Finished Product Specification Manufacturer‟s specifications
Pack size & Demanded Price 20‘s/As per SRO
Approval status of product in Reference CitroSoda Granules of Adcock Ingram Limited
Regulatory Authorities. (Bryanston, 2021)
Me-too status Citrovel Sachet by M/s Well & Well pharma
(Reg#070071)
Inspection for grant of additional sections
Panel recommends grant of additional sections.
Previous remarks of the Evaluator. Approval status of product in Reference Regulatory
Decision in previous meeting 275th Registration Board Meeting held on 25-27th
October, 2017.
Deferred for evidence of approval of applied formulation
in reference regulatory authorities/agencies.
Evaluation by PEC Registration Board in its 276th meeting deliberated the
approval of formulation since applied formulation is
considered as OTC drug by various reference regulatory
authorities.
Decision:
Registration Board approved the formulation since applied formulation is considered as OTC
drug by various reference regulatory authorities.
824. Name and address of manufacturer / M/s Demont Research Laboratories (Pvt) Ltd,
Applicant 20-km, Lahore-Shariqpur Road, Shikhupura.
Brand Name +Dosage Form + Strength Omnic Plus Sachet 40mg/1680mg
Diary No. Date of R& I & fee Diary No: 8937, 17/07/2017, Rs. 20,000/-
Type of Form Form-5
Pack size & Demanded Price 30 sachets/
As per SRO.
Approval status of product in Reference Zegerid Sachet 40mg/1680mg powders by M/s
Me-too status RULING+ 40mg/1680mg powders by M/s High-Q.
(Reg#070633)
Good Compliance.
New DML
Previous remarks of the Evaluator. Inspection report is older than 1 year.
October, 2017.
conducted within a period of last 1 year by DRAP.
Evaluation by PEC Firm has submitted GMP inspection report
26-02-2018
Grant of GMP certificate
Panel concluded that firm is operating at satisfactory level
of GMP.
Decision:
Approved.
825. Name and address of manufacturer / M/s Demont Research Laboratories (Pvt) Ltd,
Applicant 20-km, Lahore-Shariqpur Road, Shikhupura.
Brand Name +Dosage Form + Strength Omnic Plus Sachet 20mg/1680mg
Diary No. Date of R& I & fee Diary No: 8936, 17/07/2017, Rs. 20,000/-
Type of Form Form-5
Pack size & Demanded Price 30 sachets/
As per SRO.
Approval status of product in Reference Zegerid Sachet 20mg/1680mg powders by M/s
Me-too status RULING+ 20mg/1680mg powders by M/s High-Q.
(Reg#070634)
Good Compliance.
New DML
Previous remarks of the Evaluator. Inspection report is older than 1 year.
October, 2017.
conducted within a period of last 1 year by DRAP.
Evaluation by PEC Firm has submitted GMP inspection report
26-02-2018
Grant of GMP certificate
Panel concluded that firm is operating at satisfactory level
of GMP.
Decision:
Approved.
Evaluator-PEC-VIII
826. Name and address of manufacturer / M/s Aulton Pharmaceuticals, Plot # 84/1, Block A, Phase 5,
Applicant Industrial Estate, Hattar, NWFP.
Brand Name +Dosage Form + Strength Cefial Capsule 200mg
Diary No. Date of R& I & fee Dy No. 3218, 13-04-2017, Rs.20,000/-
Cefixime(as trihydrate)…200mg
Pharmacological Group Antibiotics ( Cephalosporin)
Type of Form Form-5
Finished Product Specification J.P Specifications
Pack size & Demanded Price 5‘s ; As fixed by Govt.
Approval status of product in Reference Approved in Spain
Me-too status Soxime Capsule 200mg by Swat Pharmaceuticals.
GMP status On recommendation of panel of experts, CLB in its 252nd
meeting held on 15th March, 2017 approved three
additional sections of M/s Aulton Pharmaceuticals.
Remarks of the Evaluator. i. Justification of addition of 3% overage in master
formulation.
ii. Two contradictory statements i.e.
Quantity/capsule…350.72mg and weight/capsule
…390.375mg are present in master formulation.
Clarification is required in this regard.
Previous decision. Registration Board in its 278th meeting deferred for
clarification of following observations:
i.Justification of addition of 3% overage in master
formulation.
ii.Two contradictory statements i.e.
Quantity/capsule…350.72mg and weight/capsule
…390.375mg are present in master formulation.
Evaluation by PEC Applicant has submitted correct master formulation without
overage.
Decision:
Approved.
Case No. 6 Registration applications for local manufacturing of (veterinary) drugs:
a. Routine Applications
Evaluator PEC-VII
827. Name and address of Manufacturer / M/s Leads Pharma (Pvt.) Ltd, 81-A, Street No. 06, I-
Applicant 10/3, Islamabad.
Brand Name+ Dosage Form+ Strength Doxyfas-50 powder
Composition Each 1 kg contains:-
Doxycycline HCl…………..500 g
Diary No. Date of R&I & fee Dy No.6661 ; 19-06-2017; Rs.20,000/-
Pharmacological Group Tetracyclines
Type of Form Form-5
Pack Size & Demanded Price 10 ml x 5‘s vial
Decontrolled
Approval status of product in Reference Altidox 500 mg/g powder of eurovet animal health
Regulatory Authorities (Netherland) in reference the salt in doxycycline
Hyclate form.
Me-too status Doxyback powder of attabak Pharma
GMP status GMP certificate dated 20-oct-2017
Decision:
Deferred for consideration on its turn.
Evaluator-PEC-II
828. Name and address of manufacturer / M/s ICI Pakistan Ltd, Lahore
Applicant Contract manufactured by: M/S Bio-Labs (Pvt) Ltd, Plot
3 145, Industrial Triangle, Kahuta Road Islamabad.
Brand Name +Dosage Form + Strength Lincamox- S WS POWDER
Composition Each 1gm powder contains:
Amoxicillin as (trihydrate)……200mg
Lincomycin as HCL……….88mg
Spectinomycin Dihydrochloride pentahydrate eq to
Spectinomycin……..88mg
Vitamin E……...30mg
Pharmacological Group Antibiotic, Nutritive Agent
Type of Form Form 5
Pack size & Demanded Price 100g, 500g, 1Kg, 2Kg, 3Kg, 5Kg ; As per PRC
Approval status of product in N/A
Me-too status (with strength and Lincamox-S Water Soluble Powder.Of M/S
dosage form) Breeze Pharma
GMP status Routine GMP inspection conducted on 25-01-2018
showed that non-critical observations of the inspection as
highlighted in bold italic font were discussed with
management at length. The management expressed very
firm commitment for earlier compliance to the
suggestions for further improvement of the cGMP.
Decision: Approved
Evaluator-PEC-VI
829. Name and address of manufacturer / M/s Evergreen Pharmaceuticals, Lahore

Applicant
Brand Name +Dosage Form + Strength Tilmosin Oral Solution
Tilmicosin Phosphate eq. to Tilmicosin ……250mg
Type of Form Form-5
Pack size & Demanded Price 100ml, 250ml, 500ml, 1000ml, As per SRO
Approval status of product in Reference
Me-too status Tilcosin Solution of Slemore Pharma (Reg # 035150)
GMP status Last inspection report 03-01-2018, panel decided to
recommend the renewal of DML.
Remarks of the Evaluator. Firm has Oral Liquid General and Dry powder General
(Veterinary) section.
Applicant
Brand Name +Dosage Form + Strength Emanta-10 Powder
Composition Each kg contains:
Amantadine….0.1kg
Type of Form Form-5
Pack size & Demanded Price 100gm, 500gm, 1000gm,5000gm, 15000gm, 25000gm, As
per SRO
Me-too status Antamits WSP of M/s. Wimits Pharma (Reg #078316)
Applicant
Brand Name +Dosage Form + Strength Oxy-Tec powder
Oxytetracycline HCl….0.95kg
Type of Form Form-5
Pack size & Demanded Price 100gm, 500gm, 1000gm, 5000gm, 15000gm, 25000gm
Me-too status Oxymix by Symans Reg # 023439
Decision:Approved
Applicant
Brand Name +Dosage Form + Strength Fura-G powder
Furazolidone…..0.95kg
Pharmacological Group Antibacterial, Antiprotozol
Type of Form Form-5
Pack size & Demanded Price 100gm, 500gm, 1000gm, 5000gm, 15000gm, 25000gm, As
per SRO
Me-too status Furasym powder Reg # 023435
Decision: Deferred as formulation is under review
Evaluator PEC-III
833. Name and address of manufacturer/ M/s. Zoic International, plot No 573 Sunder Industrial
Applicant Estate, Multan Road, Lahore
Brand Name+ dosage Form+ Strength Z-Aprobat Water Soluble Powder
Amprolium Hydrochloride……..200mg
Ethapobate ………………………………20mg
Diary No. Date of R&I & fee Dy No. 175: 24-04-2017
PKR 20,000/-: 24-04-2017
Pharmacological Group Macrolide/Coccidistat.
Type of Form Form 5
Pack size & Demanded price 50gm,100gm,500gm,1kg,5kg Sachet/Jar Decontrolled
Me-too status Ethoprol powder by Selmore Pharmaceutical (Reg
#049617)
GMP status GMP certificate granted on the basis of inspection dated
31-1-2018
Decision:
Brand Name+ dosage Form+ Strength Z-Dox 45 Water Soluble powder
Composition Each 1000gm contains:
Tylosin Tartrate … …200gm
Doxycycline Hyclate…. .250gm
Diary No. Date of R&I & fee Dy No 174: 24-04-2017
PKR 20,000/-24-04-2017
Pharmacological Group Antibacterial (Macrolide/tetracycline group)
Type of Form Form 5
Pack size & Demanded price 25gm,50gm, 100gm,500gm,1kg,5kg,25kg Decontrolled
Me-too status Macrodox wsp by Prix Pharmaceutical (Reg#043291)
31-1-2018
Decision:
Brand Name+ dosage Form+ Strength COLIMAX -60 Water Soluble Powder
Colistin sulphate….6,000,000IU
PKR 20,000/-24-04-2017
Pharmacological Group Antibacterial /Aminoglycoside
Type of Form Form 5
Pack size & Demanded price 25gm,50gm,100gm, 500gm, 1kg,5kg,25kg,
Decontrolled
Me-too status COLISTIN -600 wsp ,by Vigilant veterinary
services(Reg#035112)
31-1-2018
Decision:
Brand Name+ dosage Form+ Strength Ztylo-C plus water soluble powder
Composition Each 1000gm contain
Tylosin Tartarte………….……100gm
Colistin sulphate…………....500MIU
Doxycycline (as hyclate)…..200gm
PKR 20,000/-24-04-2017
Pharmacological Group Antibacterial /Macrolide /tetracycline group
Type of Form Form 5
Pack size & Demanded price 100gm,500gm, 1kg,5kg Decontrolled
Me-too status Roxycol oral powder by Mallard Pharma
31-1-2018
Decision:
Brand Name+ dosage Form+ Strength Amanta-Z water soluble powder
Composition Each 1000g contains:
Amantadine Hydrochloride…..100gm
PKR 20,000/-24-04-2017
Pharmacological Group Antibacterial/ Tricyclo amine
Type of Form Form 5
Pack size & Demanded price 100gm.500gm.1kg,5kg decontrolled
Me-too status Amantabak 10% oral powder by Attabak pharma
(Reg#075697)
31-1-2018
Decision:
Deferred for clarification of pharmacological group.
Brand Name+ dosage Form+ Strength Z-ADEK water soluble powder
Vitamin A………50,000,000IU
Vitamin D3……...5,000,000IU
Vitamin E……………….…15gm
Vitamin K3……………..12.5gm
PKR 20,000/-24-04-2017
Pharmacological Group Multi Vitamin
Type of Form Form 5
Pack size & Demanded price 50gm, 100gm, 500gm, 1kg, 5kg, 25Kg Decontrolled
Me-too status Pri-Adek Water Soluble Powder by Prix Pharma
31-1-2018
Decision:
Brand Name+ dosage Form+ Strength Z-LINCO-SP water soluble powder
Spiramycin Adipate …………….75gm
Lincomycin (as hydrochloride)…..25gm
Diary No. Date of R&I & fee Dy No 161: 24-04-2017 PKR 20,000/-24-04-2017
Type of Form Form 5
Pack size & Demanded price 25gm, 50gm, 100gm, 500gm, 1kg, 5kg, 25kg Decontrolled
Me-too status Spiralin wsp, by Symans Pharmaceutical
31-1-2018
Decision:
Brand Name+ dosage Form+ Strength Florzoc-23 Oral Liquid
Composition Each Liter Contains:
Florfenicol ………..230gm
PKR 20,000/-17-05-2017
Type of Form Form 5
Pack size & Demanded price 50ml, 100ml, 500ml, 1000ml, 5L, 10L, 25L Decontrolled
Me-too status Bioflor 23% oral liquid ,By Bio Labs(Reg#078234)
31-1-2018
Decision:
Brand Name+ dosage Form+ Strength Z-Linco -40 Water soluble powder
Composition Each 100gm oral powder contains:
Lincomycin (as hydrochloride) …..40gm
PKR 20,000/-17-05-2017
Type of Form Form 5
Pack size & Demanded price 100gm, 500gm, 1kg, 5kg, 10kg, 25kg Decontrolled
Me-too status Lincosol 40% oral powder, by M/s Unicare Enterprises
31-1-2018
Decision:
Estate, Multan Road, Lahore
Brand Name+ dosage Form+ Strength Ztylo-C Fort water soluble powder
Tylosin Tartrate…….. 140gm
Colistin sulphate …1200MIU
Doxycycline (as Hyclate )…160gm
PKR 20,000/-17-05-2017
Type of Form Form 5
Pack size & Demanded price 25g, 50g, 100g, 500g, 1kg, 5kg, 25kg decontrolled
Me-too status Tylo-Doxicol, by Prix Pharmaceutica (Reg#049526)
31-1-2018
843. Name and address of manufacturer/ Zoic International Plot # 573, Sunder Industrial Estate,
Lahore
Brand Name+ dosage Form+ Strength FLORAM 300 water soluble powder
Florfenicol………150mg
Oxytetracycline hydrochloride…..150mg
PKR 20,000/-: 24-4-2017
Pharmacological Group Tetracycline antibiotic
Type of Form Form 5
Pack size & Demanded price 50g, 100g, 500g, 1000g, 5Kg; Decontrolled
Me-too status Floxybar 30 water soluble powder by Baariq
Pharmaceuticals
31-1-2018
Lahore
Brand Name+ dosage Form+ Strength ALBAZOC-10 Oral Suspension
Albendazole…..100mg
Diary No. Date of R&I & fee Dy No. 165: 24-4-2017 PKR 20,000/-: 24-4-2017
Pharmacological Group Anthelmintic
Type of Form Form 5
Finished Product Specification BP Specs
Pack size & Demanded price 30ml, 100ml, 200ml, 500ml, 1000ml Plastic bottle;
Decontrolled
Approval status of product in Reference Albex 10% oral suspension by Chanelle animal health
Regulatory Authorities. (VMD Approved)
Me-too status Monil R10% Oral solution by Mehran International
31-1-2018
Decision: Approved.
Lahore
Brand Name+ dosage Form+ Strength LEVAZOC-50 water soluble powder
Levamisole hydrochloride…….500g
Pharmacological Group Anthelmintic
Type of Form Form 5
Pack size & Demanded price 100g, 500g, 1Kg, 5Kg; Decontrolled
Me-too status Primisol water soluble powder by Prix Pharmaceuticals
31-1-2018
Lahore
Brand Name+ dosage Form+ Strength ZASPIC Water soluble powder
Acetylsalicylic acid……..67g
Vitamin C……….200g
PKR 20,000/-: 24-4-2017
Pharmacological Group Analgesic, antipyretic, anti-inflammatory with vitamin C
Type of Form Form 5
Finished Product Specification Firm has claimed in-house specification
Pack size & Demanded price 100g, 500g, 1kg, 5kg; Decontrolled
Me-too status STR Acetyl-C Powder by Star Labs, Lahore
31-1-2018
Decision: Deferred for clarification of compatibility of both API’s.
Lahore
Brand Name+ dosage Form+ Strength ANTISTRIS-Z Water Soluble Powder
Acetylsalicylic acid…..222g
Vitamin C………..666g
PKR 20,000/-: 24-4-2017
Pharmacological Group Analgesic, antipyretic, anti-inflammatory with vitamin C
Type of Form Form 5
Pack size & Demanded price 25g, 50g, 100g, 500g, 1000g, 5kg, 25kg; Decontrolled
Me-too status Ca Super Oral Powder by Ras Pharmaceuticals
31-1-2018
Decision: Deferred for clarification of compatibility of both API’s.
Lahore
Brand Name+ dosage Form+ Strength Z-Calphos Oral Powder
Calcium…….155g
Magnesium……55g
Phosphorous…….135g
Sodium…..45g
Iron……1g
Manganese…….2g
Cobalt……0.01g
Zinc………3g
Copper……..0.6g
Iodine……..0.04g
Selenium……0.003g
PKR 20,000/-: 24-4-2017
Pharmacological Group Essential minerals (Electrolytes)
Type of Form Form 5
Pack size & Demanded price 50g, 100g, 500g, 1kg, 5kg; Decontrolled
Me-too status SP Minerals Powder by Selmore Pharma
31-1-2018
Remarks of the Evaluator. Firm has initially applied for following formulation
Each 1000g contains:
Calcium…….155g
Magnesium……55g
Phosphorous…….135g
Sodium…..45g
Iron……1000mg
Manganese…….2000mg
Cobalt……10mg
The me-too of this formulation could not be traced,

therefore the firm has requested to change the formulation
as per the me-too available. Firm has submitted
● Revised Form 5
● Fee PKR 20,000/- (dated 4-4-2018)
Decision:
Lahore
Brand Name+ dosage Form+ Strength HEPTA-Z Oral Solution
DL-Methionine………5g
L-Lysine Monochloride……10g
Choline Chloride…….19g
Cyanocobalamin………1mg
Sorbitol…………10g
Pharmacological Group Amino acids, Vitamins, carbohydrates
Type of Form Form 5
Finished Product Specification Firm has claimed in house specifications
Pack size & Demanded price 60ml, 100ml, 500ml, 1 litre Bottle/can; Decontrolled
Me-too status Hepapri oral solution by Prix Pharma
31-1-2018

Decision:
Deferred for clarification of role of sorbitol, whether it is used as Active Pharmaceutical
Ingredient or excipient.
Lahore
Brand Name+ dosage Form+ Strength Z-Florcin Water soluble powder
Composition Each grm contains:
Florfenicol…..100mg
Neomycin sulphate…..150mg
Oxytetracycline hydrochloride..….. 300mg
PKR 20,000/-: 24-4-2017
Pharmacological Group Tetracycline antibiotic
Type of Form Form 5
Pack size & Demanded price 100g, 500g, 1kg, 5kg Sachet/jar; Decontrolled
Me-too status E-Col Oral Powder by Evergreen (Reg # 081733)
31-1-2018

Decision:
Lahore
Brand Name+ dosage Form+ Strength BROM-Z Oral Liquid
Bromhexin hydrochloride……..50g
PKR 20,000/-: 24-4-2017
Pharmacological Group Secretolytic expectorant
Type of Form Form 5
Pack size & Demanded price 20ml, 50ml, 100ml, 500ml, 1000ml; Decontrolled
Me-too status Brombak solution by Attabak Pharmaceutical
31-1-2018
Decision:
Lahore
Brand Name+ dosage Form+ Strength NEOZOC 720 water soluble powder
Neomycin sulphate……720g
PKR 20,000/-: 24-4-2017
Pharmacological Group Aminoglycoside
Type of Form Form 5
Pack size & Demanded price 25g, 50g, 100g, 500g, 1000g, 5kg, 25kg Plastic Jar/Sachet;
Decontrolled
Me-too status Neo-720 water soluble powder by Prix Pharma
31-1-2018
Decision:
Lahore
Brand Name+ dosage Form+ Strength Z-SELOVIT-E OL Oral Liquid
Vitamin E……….100g
Sodium selenite……0.5g
PKR 20,000/-: 24-4-2017
Pharmacological Group Vitamin E
Type of Form Form 5
Pack size & Demanded price 100ml, 500ml, 1000ml plastic bottle; Decontrolled
Me-too status Pri-Tolevit + SE Oral Liquid by Prix Pharma
31-1-2018
Decision:
b. Deferred Cases
Evaluator PEC-XIV
854. Name and address of manufacturer / M/s. Baariq Pharmaceuticals, Plot # 600, Sundar Industrial
Applicant Estate, Sundar Raiwind Road, Lahore
Brand Name +Dosage Form + Strength Para-C+ Powder
Paracetamol……………………….20 gm
Vitamin C…………….………..…5 gm
Potassium carbonate…………...5 gm
Sodium bicarbonate………..12.5 gm
Vitamin E………………………….12.5 gm
Diary No. Date of R& I & fee 10923, 02-08-2017, Rs 20,000/-, 28-07-2017
Pharmacological Group Analgesic, Antipyretic with Vitamin C, E & Electrolytes
Type of Form Form-5
Finished Product Specification Innovator‘s specification
Pack size & Demanded Price 100g,250g, 500g,1000g,2.5Kg,5Kg,10Kg,25Kg ;
Decontrolled
Approval status of product in Could not be verified.
Me-too status Paracet Water Soluble Powder of Decent Pharma
GMP status ● The Panel inspection conducted on 09-06-2017/22-06-2017
for the renewal of Drug Manufacturing License and for the
grant of additional sections of Veterinary Liquid Injection
(General), Veterinary Oral Powder-II, Veterinary Liquid
Injection (Penicillin) and Veterinary Oral Powder
(Penicillin).
Remarks of the Evaluator. ● Evidence of approval of applied formulation in Reference
Regulatory Authority and me-too reference could not be
confirmed.
Previous decision Deferred in 275th meeting for confirmation of generic / me-
too status.
Evaluation by PEC ● The firm has submitted revised Form-5 alongwith fee of
Rs. 20,000/- (Deposit slip No. 0582128) dated 19-03-2018.
The revised formulation is as under:
● Each 100gm powder contains:
Paracetamol……………………….20 gm
Vitamin C…………….………..…5 gm
Potassium carbonate…………...12.5 gm
Sodium bicarbonate…………….12.5 gm
Vitamin E……………………….1.25 gm
● The submitted me-too reference Pozadol WSP of Leads
Pharma (Reg # 084969) has been verified.
855. Name and address of manufacturer / M/s. Baariq Pharmaceuticals, Plot # 600, Sundar Industrial
Applicant Estate, Sundar Raiwind Road, Lahore
Brand Name +Dosage Form + Strength Moxacol-N Water soluble powder
Composition Each 1000 gm contains:
Neomycin Sulphate………...….200 gm
Amoxycillin Trihydrate…..…...100 gm
Colistin Sulphate……………….50 gm
Diary No. Date of R& I & fee 10703, 01-08-2017 Rs 20,000/-, 27-07-2017
Pharmacological Group (Antibiotic)
Type of Form Form-5
Pack size & Demanded Price 100g, 250g, 500g, 1Kg, 2.5Kg, 5Kg, 10Kg, 25Kg;
Decontrolled
Approval status of product in Amoxycol WS
Reference Regulatory Authorities. Avivet Pharma India
Me-too status NEO AC Water Soluble Powder of Decent Pharma Reg #
079844)
GMP status The Panel inspection conducted on 09-06-2017/22-06-2017
for the renewal of Drug Manufacturing License and for the
grant of additional sections of Veterinary Liquid Injection
(General), Veterinary Oral Powder-II, Veterinary Liquid
Injection (Penicillin) and Veterinary Oral Powder
(Penicillin).
Remarks of the Evaluator. ● Evidence of approval of applied formulation in Reference
Regulatory Authority could not be confirmed.
● Clarification of salt form is required.
Previous decision Deferred in 275th meeting for clarification of strength of
applied formulation in terms of amoxicillin base
Evaluation by PEC ● The firm has submitted revised Form-5 clarifying the
strength of applied formulation in terms of amoxicillin base
i.e.,
● Each 1000 gm contains:
Neomycin Sulphate………...….200 gm
Amoxycillin as Trihydrate…..…...100 gm
Colistin Sulphate……………….50 gm
Decision:
856. Name and address of manufacturer / M/s. ICI Pakistan Ltd, Life Sciences, 45-KM, Multan Road,
Applicant Lahore
Brand Name +Dosage Form + Strength Dayfos Liquid Injection
Toldimfos Sodium……………….100mg
Diary No. Date of R& I & fee 10046, 26-07-2017, 20,000/-25-07-2017
Pharmacological Group Alimentary tract Mineral supplements
Type of Form Form 5
Pack size & Demanded Price 50ml; Decontrolled
Approval status of product in Vetophos® Injection; Bela-pharm GmbH & Co. KG, Lohner
Reference Regulatory Authorities. Str. 19, 49377 Vechta Germany
Me-too status Metafos Injection of Star Laboratories, Lahore.
GMP status ● CLB in its 254th meeting held on 15th June,2017 has
considered and approved the grant of one additional section
i.e., Liquid injectable (SVP) Vet.
Remarks of the Evaluator. ● The firm has submitted revised Form-5 stating correct salt
form Toldimfos sodium Trihydrate……100mg Eq. to
Toldimfos sodium…..80.36mg which has been verified from
database of Germany. However, me-too reference is
registered in Toldimfos sodium …..100mg.
● Indicated species:
Cattle, horse, Calf, Foal, Sheep
Previous decision Deferred in 275th meeting for verification of salt form of API
as reference product is available as Toldimfos sodium
trihydrate whereas firm has applied for Toldimfos sodium.
Deferred in 277th meeting for clarification of statement ―As
API Toldimfos sodium.3H2O is not available in the local
market‖ and submission of correct COA of API.
Evaluation by PEC The firm clarified that there is typographical mistake in the
previous statement. The correct statement is that
―API Toldimfos sodium trihydrate is available in the
international market and its COA has also been provided but
me-too reference is not available with Toldimfos sodium
trihydrate.
The me-too reference is only available with Toldimfos
sodium i.e., ―Metafos Injection of Star laboratories, Reg #
027498‖ has been verified.
857. Name and address of manufacturer / M/s. ICI Pakistan Ltd, Life Sciences, 45-KM, Multan Road,
Applicant Lahore
Brand Name +Dosage Form + Strength Dayfos Liquid Injection
Toldimfos Sodium……………….100mg
Diary No. Date of R& I & fee 10046, 26-07-2017, 20,000/-25-07-2017
Pharmacological Group Alimentary tract Mineral supplements
Type of Form Form 5
Pack size & Demanded Price 100ml; Decontrolled
Approval status of product in Vetophos® Injection; Bela-pharm GmbH & Co. KG, Lohner
Reference Regulatory Authorities. Str. 19, 49377 Vechta Germany
Me-too status Metafos Injection of Star Laboratories, Lahore.
GMP status ● CLB in its 254th meeting held on 15th June,2017 has
considered and approved the grant of one additional section
i.e., Liquid injectable (SVP) Vet.
Remarks of the Evaluator. ● The firm has submitted revised Form-5 stating correct salt
form Toldimfos sodium Trihydrate……100mg Eq. to
Toldimfos sodium…..80.36mg which has been verified from
database of Germany. However, me-too reference is
registered in Toldimfos sodium …..100mg.
● Indicated species:
Cattle, horse, Calf, Foal, Sheep
Previous decision Deferred in 275th meeting for verification of salt form of API
as reference product is available as Toldimfos sodium
trihydrate whereas firm has applied for Toldimfos sodium.
Deferred in 277th meeting for clarification of statement ―As
API Toldimfos sodium.3H2O is not available in the local
market‖ and submission of correct COA of API.
Evaluation by PEC The firm clarified that there is typographical mistake in the
previous statement. The correct statement is that
―API Toldimfos sodium trihydrate is available in the
international market and its COA has also been provided but
me-too reference is not available with Toldimfos sodium
trihydrate.
The me-too reference is only available with Toldimfos
sodium i.e., ―Metafos Injection of Star laboratories, Reg #
027498‖ has been verified.
Case No. 7 Registration applications of newly granted DML or New section (Veterinary):
a. New DML /section
Evaluator PEC-XIV
1. M/s. Biorific Pharma, Plot No. 143, Industrial Triangle Kahuta Road, Islamabad
The CLB in 250th meeting held on 27th October 2016 has considered and approved the grant of Drug
Manufacturing License (by way of formulation) vide letter No. F.1-48/2003-lic with following sections:
● Dry powder Section (Veterinary)

● Liquid Syrup Section (Veterinary)
The details of already approved and deferred products in various meetings of Registration Board are as
under:
Sr. Name of section No. of molecules Deferred Remaining

No. already approved molecules molecules
Dry powder Section
1. 6 4 -
(Veterinary)
Liquid Syrup Section
2. 4 4 2
(Veterinary)
Now, the firm has applied two remaining molecules in Liquid general section. Moreover, firm has applied
four products as replacements of already deferred products.
Liquid syrup section (2 molecules remaining)

858. Name and address of manufacturer / M/s. Biorific Pharma, Plot No.143, Industrial Triangle
Applicant Kahuta Road, Islamabad.
Brand Name +Dosage Form + Strength Respiquin AG (Vet) Liquid
Composition Each 100ml liquid contains:
Enrofloxacin……………10gm
Aminophylline…………4gm
Guaiphenesin……….....10gm
Pharmacological Group Antibiotic, Expectorant
Type of Form Form-5
Finished Product Specification In house specification
Pack size & Demanded Price 100ml, 200ml, 500ml, 1000ml Plastic container;
Decontrolled
Me-too status EG ENRO PLUS LIQUID of M/s Elegance Pharma (Reg #
074099)
GMP status The firm was granted new DML based on inspection
Remarks of the Evaluator. ●
Brand Name +Dosage Form + Strength Tylophylline (Vet) Liquid
Composition Each 100ml liquid contains:
Doxycycline HCl…………..20gm
Tylosin tartrate………………10gm
Guaiphenesin………………..20gm
Aminophylline………………8gm
Pharmacological Group Antibiotic/Expectorant
Type of Form Form-5
Decontrolled
Me-too status TYCO-G ORAL LIQUID of M/s Attabak Pharma (Reg #
075704)
Remarks of the Evaluator. ●
Replacements of already deferred products

Brand Name +Dosage Form + Strength BROMOTECH Liquid
Bromhexine HCl…………….50mg
Pharmacological Group Expectorant
Type of Form Form-5
Decontrolled
Me-too status BROMOMONT ORAL LIQUID of M/s Westmont Pharma
(Reg # 063742)
Remarks of the Evaluator. Replacement of Acedex Liquid deferred in 266th meeting
Decision:
Brand Name +Dosage Form + Strength ENCOTYL Liquid
Enrofloxacin………………20gm
Colistin sulphate……….....50MIU
Type of Form Form-5
Decontrolled
Me-too status MAXEN LIQUID of M/s D-Maarson Pharma (Reg #
075749)
Remarks of the Evaluator. Replacement of Nutravet Liquid deferred in 271st meeting
Brand Name +Dosage Form + Strength Neoflox (Vet) Dry Powder
Neomycin sulphate………………….720gm
Type of Form Form-5
Decontrolled
Approval status of product in Neomix 325 soluble powder approved by FDA
Me-too status Neomycin-72 Water Soluble Powder of M/s Farm Aid
Pharma (Reg # 029669)
Remarks of the Evaluator. Replacement of Ronlex Powder deferred in 266th meeting
Brand Name +Dosage Form + Strength Amprocox 50
Composition Each gm powder contains:
Amprolium…………..500mg
Pharmacological Group Antiprotozoal
Type of Form Form-5
Decontrolled
Approval status of product in Amprol 128 powder of Huve Pharma FDA approved
Me-too status Ampro powder of Nawal Pharma (Reg # 072631)
Remarks of the Evaluator. Replacement of Vitafic Powder deferred in 266th meeting
Case No. 8 Registration applications of drugs for which stability study data is required to
be verified:
Evaluator PEC-VIII
The Firm‖Getz Pharma‖ has submitted a letter stating as under ‖Registration Board in its
st
271 meeting has directed us to submit stability studies data of our product Arcox (Etoricoxib
90mg and 120mg). Our subject products are pending since 2009.
We have now manufactured 3 batches of our products and submitted the required stability data
along with all relevant documents as per decision of 251st RB meeting.
The firm also quoted the 214th RB meeting minutes decision,‖The Registration board took
a policy decision that once a drug is registered under Drug Act, 1976, then applications for the
same drug with similar dosage form but different strengths will be considered as Me Too instead
of New Drug. Hence such application will be applied on Form-5 rather then on Form-5D and
Rs.8,000/- will be deposited on account of registration board‖
Firm further added that Registration Board is requested to treat our product as line
extension of already registered product ―Etoricoxib 60mg tablet‖ as we already have registration
of Etoricoxib 60mg since May 2013, and we are marketing it as well.‖
Now the case has been placed before the Board for consideration of Board.
864. Name and address of manufacturer / M/s Getz Pharma (Pvt.) Ltd. 29-30/27, Korangi
Brand Name +Dosage Form + Strength Arcox Tablets 90mg
Etoricoxib…90mg
Diary No. Date of R& I & fee Duplicate Dossier; Rs. 15,000/-, 28-07-2009, Rs.
35,000/-, 30-07-2013,
Type of Form Form-5D
Pack size & Demanded Price 14‘s: Rs. 870.00/- per pack, Rs. 62.14/- per tablet
Me-too status (with strength and dosage N/A
form)
GMP status
STABILITY STUDY DATA
Drug Arcox Tablets 90mg (Etoricoxib 90mg)
Name of Manufacturer M/s Getz Pharma (Pvt.) Ltd. 29-30/27, Korangi
Industrial Area, Karachi.
Manufacturer of API Glenmark Pharmaceutical Ltd, India
API Lot No. 84170074
Description of Pack
Alu-Alu blister
(Container closure system)
Stability Storage Condition Real Time: 30oC ± 2oC / 65% ± 5%RH
Accelerated:40oC ±2oC / 75% ± 5%RH
Time Period Real Time: 06 Months
Accelerated: 06 Months
Frequency Real Time: 0,3,6 Months(on going)
Accelerated: 0,3,6 Months
Batch No. 412DS01 412DS02 412DS03
Batch Size 25000 tablets 25000 tablets
25000 tablets
Manufacturing Date 19-05-2017 31-05-2017 31-05-2017

Date of Initiation 15-06-2017 15-06-2017 15-06-2017
No. of Batches 03
Date of Submission Dy No.3457, 26-01-18
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr. Documents To Be Provided Status
No.
1. COA of API Yes
2. Approval of API by regulatory authority of country Copy of GMP certificate having a number
of origin or GMP certificate of API manufacturer 6076982 issued for Export Registration by
issued by regulatory authority of country of origin. Licensing Authority Food & Drug administration
Pune Division, Maharashtra State valid for a
period from 01-08-2017 to 31-07-2018.
3. Protocols followed for conduction of stability study Yes
and details of tests.
4. Data of 03 batches will be supported by attested Yes
respective documents like chromatograms,
laboratory reports, data sheets etc.
5. Documents confirming import of API etc. Yes
6. All provided documents will be attested (name, sign
and stamp) for ensuring authenticity of data / Yes
documents.
7. Commitment to continue real time stability study till Yes
assigned shelf life of the product.
8. Commitment to follow Drug Specification Rules, Yes
1978.
REMARKS OF EVALUATOR
● The firm has claimed In House specifications and the product is not present in USP/BP.
Decision: Board decided as follows:
Onsite inspection by following panel to confirm genuineness/ authenticity of stability data and
associated documents, import of API, quality, specification, test analysis, facilities etc:
i. Dr. Rafeeq Alam Khan, Meritorious Professor / Member Registration Board.
ii. Dr. Saif-ur-Rehman Khattak, Director / FGA, CDL, DRAP, Karachi.
iii. Affan Ali Qureshi, Assistant Director, CDL, DRAP, Karachi.
OR
Firm can submit requisite documents as decided in 278th meeting of Registration Board to claim
exemption form on site investigation of submitted stability data
865. Name and address of manufacturer / M/s Getz Pharma (Pvt.) Ltd. 29-30/27, Korangi
Brand Name +Dosage Form + Strength Arcox Tablets 120mg
Etoricoxib…120mg
Diary No. Date of R& I & fee Duplicate Dossier; Rs. 15,000/-, 28-07-2009, Rs.
35,000/-, 30-07-2013, (Photocopies)
Pack size & Demanded Price 7‘s: Rs. 585.00/- per pack, Rs. 83.57/- per tablet
form)
GMP status
Drug Arcox Tablets 120mg (Etoricoxib 120mg)
Name of Manufacturer M/s Getz Pharma (Pvt.) Ltd. 29-30/27, Korangi
Manufacturer of API Glenmark Pharmaceutical Ltd, India
API Lot No. 84170074
Description of Pack
Alu-Alu blister
Time Period Real Time: 06 Months
Frequency Real Time: 0,3,6 Months(on going)
Accelerated: 0,3,6 Months
Batch No. 412DS01 412DS02 412DS03
Batch Size 25000 tablets 25000 tablets
25000 tablets

No. of Batches 03
No.
1. COA of API Yes
2. Approval of API by regulatory authority of country Copy of GMP certificate having a number
of origin or GMP certificate of API manufacturer 6076982 issued for Export Registration by
issued by regulatory authority of country of origin. Licensing Authority Food & Drug administration
Pune Division, Maharashtra State valid for a
period from 01-08-2017 to 31-07-2018.
respective documents like chromatograms,
documents.
1978.
Decision:
Board decided as follows:
associated documents, import of API, quality, specification, test analysis, facilities etc:
i. Dr. Rafeeq Alam Khan, Meritorious Professor / Member Registration Board.
ii. Dr. Saif-ur-Rehman Khattak, Director / FGA, CDL, DRAP, Karachi.
iii. Affan Ali Qureshi, Assistant Director, CDL, DRAP, Karachi.
OR
Firm can submit requisite documents as decided in 278th meeting of Registration Board to claim
exemption form on site investigation of submitted stability data
Evaluator PEC-II
VERIFICATOIN OF GENUINENESS / AUTHENTICITY OF STABILITY DATA AND

ASSOCIATED DOCUMENTS
Sr. Name & Address of Brand Name Type of Form, International
No. Manufacturer / Applicant (Proprietary Name + Initial Diary & Date, Availability / Local
Dosage Form + Fee (including Availability
Strength), Composition, differential fee),
Pharmacological Group, Demanded Price / GMP Inspection
Finished Product Pack size Report Date &
Specification Remarks
866. M/s Getz Pharmaceuticals, Glardin-M Tablet Form-5-D USFDA Approved.
30-31, Sector 27, Korangi 12.5mg/1000 mg Dy. No: 410 GMP inspection
Industrial Area, Karachi. Tablet Dated.25-03-2016 report conducted on
Each film coated tablet Rs.50,000/- (25-03- 05-07-2017,
contains: 2016) concluding
Empagliflozin 14‘s; Rs. 4,500/- acceptable level of
…...............12.5mg GMP compliance.
Metformin hydrochloride
………..1000mg
(Anti Diabetic)
Evaluation by PEC:
Firm has submitted stability study data, with following statement:
―Kindly note that the analytical testing method submitted in the Registration application of
Glardin-M tablets 5mg+500mg was established at the time of initial development. However, before
placing of said product on stability studies, we established & validated the analytical testing
method. The same method has been used in 06 months stability study data and same method will
be used for on-going real time stability studies.‖
Details of Stability study data are as under:
Drug Glardin-M Tablet 12.5mg/1000 mg
Name of Manufacturer M/s Getz Pharmaceuticals, Karachi.
Manufacturer of API Empagliflozin: M/s Jiangsu Yongan Pharmaceutical Co., Ltd.
Metformin hydrochloride: M/s Wanbury Ltd., Andhrapradesh, India
API Lot No. Empagliflozin: 20160602 & 20161218
Metformin hydrochloride: MT06680415
Description of Pack
Alu-Alu in bleach board carton with leaflet
Stability Storage Condition Real time : 30°C ± 2°C / 75% ± 5% RH
Accelerated: 40°C ± 2°C / 75% ± 5% RH
Time Period Real time: 6 months
Accelerated: 6 months
Frequency Accelerated: 0,3,6 (month)
Real Time: 0,3,6 (month)
Batch No. 395DS01 395DS02 394DS03
Batch Size 1500 tablets 1500 tablets 1500 tablets
Manufacturing Date 04-2017 05-2017 05-2017
Date of Initiation 05-2017 05-2017` 05-2017
No. of Batches 03
Date of Submission 18-12-2017 (Dy. No. 24969)
Sr.# Documents To Be Provided Status
1. COA of API Yes
2. Approval
0 of API by regulatory authority of country of Empagliflozin: Copy of GMP certificate
origin or GMP certificate of API manufacturer issued issued to M/s M/s Jiangsu Yongan
by regulatory authority of country of origin. Pharmaceutical Co., Ltd by Jiangsu Food &
Drug Administration, valid upto 03-03-2021.
The said certificate has been verified from
following website link when accessed on 26-
12-2016:
http://www.jsfda.gov.cn/datacenter/dc/view/9
f1d0fb703274b44b31ce1d8919f587b?type=2
Metformin hydrochloride: Copy of GMP
3179/MIA/Mfg/2016) issued by Drug Control
Administration, Andhrapradesh, valid upto
07-12-2018
3. Protocols followed for conduction of stability study and
Yes
details of tests.
4. Data of 03 batches will be supported by attested
respective documents like chromatograms, laboratory Yes
reports, data sheets etc.
5. Documents confirming import of API etc. Empagliflozin: Copy of Form 6 (License to
Import Drugs for Clinical trial examination,
Test analysis) has been submitted issued by
ADC, Karachi DRAP.
Metformin hydrochloride: Copy of
commercial invoice for Metformin
hydrochloride has been submitted. The said
invoice is attested by ADC, Karachi DRAP.
documents.
7. Commitment to continue real time stability study till
Yes
8. Commitment to follow Drug Specification Rules, 1978. Yes
● The weight of each tablet as calculated from master formulation is 1136mg, whereas average weight of
each tablet mentioned in finished product specifications (submitted along with stability studies data) is
1230mg. Clarification is required in this regard.
● The description of tablet as mentioned in dossier is ―Brown colored, film coated round tablets‖ whereas
that mentioned in stability study data is ―Lilac colored, oblong shaped biconvex film coated tablet, plain
on both sides.‖ Clarification is required in this regard.
● The documents of Stability Study Protocol & Finished product specifications do not have any
issue/effective date.
● Storage date of trail batches for stability studies shall be submitted.
● The dissolution analysis for Empagliflozin & Metformin hydrochloride has been performed on different
dates (as evident from submitted HPLC chromatograms & UV spectrums), whereas dissolution analysis of
both Empagliflozin & Metformin hydrochloride shall be performed from similar sample aliquot. The
details of this observation are as under:
Batch No. Time point of stability Dissolution analysis Dissolution analysis date for
studies date for Empagliflozin Metformin hydrochloride
395DS01 Initial testing (zero time) 14-04-2017 25-04-2017

● Above observation were communicated to firm vide letter no. F.1-1/2017/PEC-DRAP (AD PEC-II) dated
27-12-2017, to which firm has responded as under:
Sr.# Deficiency/Observation Response by Getz Pharma.
i. The weight of each tablet as calculated Firm has submitted master formulation upon which
from master formulation is 1136mg, stability batches have been prepared.
whereas average weight of each tablet
mentioned in finished product
specifications (submitted along with
stability studies data) is 1230mg.
ii. The description of tablet as mentioned in Firm has submitted master formulation upon which
dossier is ―Brown colored, film coated stability batches have been prepared.
round tablets‖ whereas that mentioned in
stability study data is ―Lilac colored,
oblong shaped biconvex film coated
tablet, plain on both sides.‖ Clarification
is required in this regard.
iii. The documents of Stability Study Protocol Firm has submitted copy of Finished product testing
& Finished product specifications do not method (Rev. No 02) with effective date of 20-10-
have any issue/effective date. 2017. The document history as described in the
submitted finished product testing method states that
preparation date of the first edition was 13-03-2017.
Firm has stated in their reply that effective date for
stability protocol is same as that of Finished product
testing method.
iv. The date from which stability study have Firm has submitted Stability Study Data Sheet which
been started or stored in chambers has not mentions date of initiation & implementation as 16-
been mentioned. 05-2017 for all three stability batches of stability
study.
v. The dissolution analysis for Empagliflozin i. Initially we used HPLC method for both the
& Metformin hydrochloride has been APIs and the dissolution testing of Batch#
performed on different dates (as evident 395DS01 was performed on date 14-04-2017 on
from submitted HPLC chromatograms & HPLC. But a dissolution medium behavior has
UV spectrums), which is scientifically not been observed at the retention time of
justifiable as dissolution analysis of both Metformin peak which causes problem for
Empagliflozin & Metformin accurate and reliable integration of the peak.
hydrochloride shall be performed from Later on based on that issue, the method has
similar sample aliquot. been re-developed on UV spectrophotometer
and Metformin HCL dissolution has been re
analyzed on date 25-04-2017 on UV method.
ii.
Also this is to inform you that dissolution of
both APIs for rest of the two batches (Batch #
395DS02 & Batch # 395DS03) were analyzed
on the same date i.e., 08-05-2017 but due to the
long HPLC sequence of Empagliflozin, the
system continued till the date changes from 08-
05-2017 to 09-05-2017. Analysis of
Empagliflozin on HPLC state date is 08-5-2017
while sequence completed on 09-05-2017.
vi. Justification is required since you have This is to clarify that initially we used HPLC method
used UV method in dissolution testing for for of both the APIs and the dissolution testing of
Metformin while in Assay testing you Batch # 395DS01 was performed on HPLC. But a
have used HPLC method for same API. dissolution medium behavior has been observed at
the retention time of Metformin HCl peak. Later on
based on that issue, the method has been re-
developed on UV spectrophotometer.
We have developed dissolution method for
Metformin HCl on UV based on USP general chapter
<1092> ―The Dissolution Procedure: Development
and Validation‖ which states that
―Spectrophotometric determination for dissolution is
used often because results can be obtained faster, the
analysis is simpler, it is easier to automate, and fewer
solvents are needed. The use of direct
spectrophotometric determination typically requires
confirmation of the specifically.‖
We have established the specificity of the method by
analyzing the placebo and Empagliflozin and the
method is found to be specific for metformin HCl
having no interferences from the placebo and
Empagliflozin samples.
Also, most of the USP monograph for tablets having
Metformin HCl whereas its assay is on HPLC.
Following are few references.
● Metformin hydrochloride tablets

● Glyburide and Metformin hydrochloride tablets
● Glipizide and Metformin hydrochloride tablets
vii. How it could be justified that the results of During the Dissolution method development of
dissolution analysis for Metformin as Metformin HCl on UV spectrophotometer, the
performed by UV method have not been interference study was performed. Both the placebo
interfered with the other API i.e. and Empagliflozin was analyzed on the method to
Empagliflozin present in the same sample check the method specificity.
aliquot. No interference has been observed of both the
placebo & Empagliflozin which shows that the
method is specific for Metformin HCl as shown
below:
Sample name Absorbance
Placebo -0.002
Metformin HCl 0.614
Empagliflozin 0.002
No. Manufacturer / Applicant (Proprietary Name + Initial Diary & Date, Availability / Local
Dosage Form + Fee (including Availability
Strength), Composition, differential fee),
Pharmacological Group, Demanded Price / GMP Inspection
Finished Product Pack size Report Date &
867. M/s Getz Pharmaceuticals, Glardin-M Tablet Form-5-D USFDA Approved.
30-31, Sector 27, Korangi 5mg/500 mg Dy. No: 379 GMP inspection
Industrial Area, Karachi. Tablet Dated.18-03-2016 report conducted on
Each film coated tablet Rs.50,000/- (18-03- 05-07-2017,
contains: 2016) concluding
Empagliflozin 14‘s; Rs. 2,000/- acceptable level of
…............... 5mg GMP compliance.
Metformin hydrochloride
………..500mg
(Anti Diabetic)
Evaluation by PEC:
Firm has submitted stability study data, with following statement:
―Kindly note that the analytical testing method submitted in the Registration application of Glardin-M
tablets 5mg+500mg was established at the time of initial development. However, before placing of said
product on stability studies, we established & validated the analytical testing method. The same method
has been used in 06 months stability study data and same method will be used for on-going real time
stability studies.‖
Details of Stability study data are as under:
Drug Glardin-M Tablet 5mg/500 mg
Name of Manufacturer M/s Getz Pharmaceuticals, Karachi.
Manufacturer of API Empagliflozin: M/s Jiangsu Yongan Pharmaceutical Co., Ltd.
Metformin hydrochloride: M/s Wanbury Ltd., Andhrapradesh, India
API Lot No. Empagliflozin: 20161218
Metformin hydrochloride: MT06680415
Description of Pack
Alu-Alu in bleach board carton with leaflet
Batch No. 394DS02 394DS03 394DS04
Manufacturing Date 05-2017 05-2017 16-05-2017
Date of Initiation 16-05-2017 16-05-2017` 05-2017
No. of Batches 03
Sr.# Documents To Be Provided Status
1. COA of API Yes
2. Approval
0 of API by regulatory authority of country of Empagliflozin: Copy of GMP certificate
origin or GMP certificate of API manufacturer issued issued to M/s Jiangsu Yongan
by regulatory authority of country of origin. Pharmaceutical Co., Ltd by Jiangsu Food &
The said certificate has been verified from
following website link when accessed on 26-
12-2016:
http://www.jsfda.gov.cn/datacenter/dc/view/9
f1d0fb703274b44b31ce1d8919f587b?type=2
Metformin hydrochloride: Copy of GMP
3179/MIA/Mfg/2016) issued by Drug Control
Administration, Andhrapradesh, valid upto
07-12-2018
3. Protocols followed for conduction of stability study and
Yes
details of tests.
respective documents like chromatograms, laboratory Yes
5. Documents confirming import of API etc. Empagliflozin: Copy of Form 6 (License to
Import Drugs for Clinical trial examination,
Test analysis) has been submitted issued by
ADC, Karachi DRAP.
Metformin hydrochloride: Copy of
commercial invoice for Metformin
hydrochloride has been submitted. The said
invoice is attested by ADC, Karachi DRAP.
documents.
7. Commitment to continue real time stability study till
Yes
8. Commitment to follow Drug Specification Rules, 1978. Yes
i. The weight of each tablet as calculated from master formulation is 574mg, whereas average weight of
each tablet mentioned in finished product specifications (submitted along with stability studies data) is
618mg. Clarification is required in this regard.
ii. The description of tablet as mentioned in dossier is ―Yellow colored, film coated round tablets‖
whereas that mentioned in stability study data is ―Mustard colored, oblong shaped biconvex film
coated tablet, plain on both sides.‖ Clarification is required in this regard.
iii. The documents of Stability Study Protocol & Finished product specifications do not have any
issue/effective date.
iv. Storage date of trail batches for stability studies shall be submitted.
v. Above observation were communicated to firm vide letter no. F.1-1/2017/PEC-DRAP (AD PEC-II)
dated 27-12-2017, to which firm has responded as under:
Sr.# Deficiency/Observation Response by Getz Pharma.
i. The weight of each tablet as Firm has submitted master formulation upon which stability
calculated from master batches have been prepared.
formulation is 574mg, whereas
average weight of each tablet
mentioned in finished product
specifications (submitted along
with stability studies data) is
618mg.
ii. The description of tablet as Firm has submitted master formulation upon which stability
mentioned in dossier is ―Yellow batches have been prepared.
colored, film coated round
tablets‖ whereas that mentioned
in stability study data is ―Mustard
colored, oblong shaped biconvex
film coated tablet, plain on both
sides.‖
iii. The documents of Stability Study Firm has submitted copy of Finished product testing
Protocol & Finished product method (Rev. No 02) with effective date of 20-10-2017.
specifications do not have any The document history as described in the submitted
issue/effective date. finished product testing method states that preparation date
of the first edition was 13-03-2017.
Firm has stated in their reply that effective date for stability
protocol is same as that of Finished product testing
method.
iv. Justification is required since you This is to clarify that initially we used HPLC method for
have used UV method in both the APIs and the dissolution testing of Batch #
dissolution testing for Metformin 395DS01 was performed on HPLC. But a dissolution
while in Assay testing you have medium behavior has been observed at the retention time of
used HPLC method for same API. Metformin HCl peak. Later on based on that issue, the
method has been re-developed on UV spectrophotometer.
We have developed dissolution method for Metformin HCl
on UV based on USP general chapter <1092> ―The
Dissolution Procedure: Development and Validation‖
which states that ―Spectrophotometric determination for
dissolution is used often because results can be obtained
faster, the analysis is simpler, it is easier to automate, and
fewer solvents are needed. The use of direct
spectrophotometric determination typically requires
confirmation of the specificity.‖
We have established the specificity of the method by
analyzing the placebo and Empagliflozin and the method is
found to be specific for Metformin HCl having no
interferences from the placebo and Empagliflozin samples.
Also, most of the USP monograph for tablets having
Metformin HCl whereas its assay is on HPLC. Following
are few references.
● Metformin hydrochloride tablets
● Glyburide and Metformin hydrochloride tablets
● Glipizide and Metformin hydrochloride tablets
v. How it could be justified that the During the Dissolution method development of Metformin
results of dissolution analysis for HCl on UV spectrophotometer, the interference study was
Metformin as performed by UV performed. Both the placebo and Empagliflozin was
method have not been interfered analyzed on the method to check the method specificity.
with the other API i.e. No interference has been observed of both the placebo &
Empagliflozin present in the same Empagliflozin which shows that the method is specific for
sample aliquot. Metformin HCl as shown below:
Sample name Absorbance

Placebo -0.002
Metformin HCl 0.614
Empagliflozin 0.002
vi. The date from which stability Firm has submitted Stability Study Data Sheet which
study have been started or stored mentions date of initiation & implementation as 16-05-2017
in chambers has not been for all three stability batches of stability study.
mentioned.
Report on Investigation of Authenticity / Genuineness of submitted stability data
Background: The applications of M/s. Getz Pharma (Pvt.) Limited, 29-30, Sector-27, Korangi Industrial
Area, Karachi, were evaluated in PEC along with stability study data as per details cited above. Subsequently
the Chairman Registration Board constituted a three member panel to investigate the authenticity /
genuineness of data (import of raw material and stability data).
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Glardin-M
5mg/500mg and Glardin-M 12.5mg/1000mg (Empagliflozin + Metformin HCl) Tablets by M/s. Getz
Pharma (Pvt.) Limited, 29-30, Sector-27, Korangi Industrial Area, Karachi.
Reference No: F.2-16/2016-PEC (M-277) dated 21st February, 2018.

Investigation Date and Time: 27th March, 2018. (Afternoon)
Investigation Site: Factory premises of M/S. Getz Pharma, (Pvt.) Limited, K.I.A, Karachi.
Composition of Panel:
1. Prof. Dr. Ghulam Sarwar, Dean, Faculty of Phamracy, Jinnah University for Women, 5-C, St-1,
Nazimabad, Karachi.
2. Dr. Saif-ur-Rehman Khattak, Director / FGA, CDL, DRAP, Karachi.
3. Dr. Affan Ali Qureshi, Assistant Director, CDL, DRAP, 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 of DRAP. For objective evidence
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
were also audited. The details of investigation may be summarized as under:
Detail of Investigation:
Q.
Question Observation by panel
No.
1. Do you have documents The firm has imported Empagliflozin API 1Kg & 0.5Kg from
confirming the import of M/s Jiangsu Yongan Pharmaceutical Co., Ltd, China and has
Empagliflozin & Metformin HCl approval from DRAP for import vide License No.1762/16-
API including approval from DRAP(K) dated 29.06.2016 and No.0570/17-DRAP(K) dated
DRAP? 28.02.2017.
Date of Quantity
Batch No. Invoice No.
Import imported
29 Jun
20160602 16CAGZ001 1Kg
2016
28 Feb
20161218 16CAGZ008 0.5Kg
2017
Firm has imported Metformin HCl from M/s Wanbury Ltd.,
India and has approval from DRAP for import vide License
No. DCA/(K)/HD/2013(1617) dated July 31, 2013. Dates &
Quantities of import are as follows:
Batch Date of Quantity

Invoice No.
No. Import imported
MT0668 EXP/95009385
05 May 2015 1280Kg
0415 /15-16
2. What was the rationale behind There is proper vendor evaluation process being implemented
selecting the particular by the firm and the rationale behind vendor selection is
manufacturer of API? controlled through:
● Postal Audit checklist
● Physical Site Inspection
● Testing of at least two lots of API to confirm the
consistency
● GMP approval by competent authority
3. Do you have documents Firm imported Empagliflozin reference standard 100mg from
confirming the import of M/s Jiangsu Yongan Pharmaceutical Co., Ltd, China vide
empagliflozin & metformin HCl invoice No. 16CAGZ001 dated 30.05.2016 and 10mg of
reference standard and impurity Empagliflozin Impurity A from M/s Jiangsu Yongan
standards? Pharmaceutical Co., Ltd, China vide invoice No. 17EPGZ002
dated 20.04.2017.
For Metformin HCl, firm imported reference standard from

USP vide invoice No. 706/GP/LS/2014 dated January 22, 2014.
Firm imported reference standard of Metformin Related

Compound A from USP vide invoice No. 564 dated October
07, 2016.
The firm has method to detect and quantify impurities.
4. Do you have certificate of The firm has certificates of analysis for API and reference /
Analysis of the API, reference working standard.
standards and impurity standards?
5. Do you have GMP certificate of Firm has provided copy of valid GMP certificate of M/s
API manufacturer issued by Jiangsu Yongan Pharmaceutical Co., Ltd, China for
regulatory authority of country of Empagliflozin valid till 31-12-2020. The manufacturer has
origin? been permitted for manufacturing of Empagliflozin by Huaian
Market Supervision Administration, China.
Firm also provided copy of valid GMP certificate of M/s
Wanbury Ltd., India for Metformin HCl valid till 28-07-2018
issued by Director, Drugs Control Administration, Government
of Andhra Pradesh - India.
6. Do you use API manufacturer The firm has used API manufacturer‘s method of testing for
method of testing for testing API? Empagliflozin.
For Metformin HCl pharmacopeial method has been used for
testing.
7. Do you have stability studies The firm has stability studies reports on API.
reports on API?
8. If yes, whether the stability testing The stability testing has been performed as per SIM method
has been performed as per SIM and degradation products have been quantified for both
method and degradation products Empagliflozin & Metformin HCl.
have been quantified?
9. Do you have method for The firm has method for quantifying the impurities in
quantifying the impurities in the Empagliflozin and Metformin HCl.
API?
10. Do you have some remaining The firm has some remaining quantities of the API working
quantities of the API, its reference standard and impurity standard.
standard and impurities standards?
11. Have you used pharmaceutical The firm have used pharmaceutical grade excipients which
grade excipients? include Corn Starch, Copovidone, Colloidal silicon dioxide and
Magnesium Stearate. Film coating materials include Opadry
Yellow (5mg + 500mg) & Opadry Purple (12.5mg + 1000mg).
12. Do you have documents The firm has necessary documents confirming the import of the
confirming the import of the used used excipients.
excipients?
13. Do you have test reports and other The firm has test reports and other records on the excipients
records on the excipients used? used.
14. Do you have written and The firm has written and authorized protocols for the
authorized protocols for the development of Empagliflozin + Metformin HCl Tablets 5mg
development of empagliflozin & + 500mg & Empagliflozin + Metformin HCl Tablets 12.5mg +
metformin HCl tablets? 1000mg.
15. Have you performed Drug- Since firm has used same excipients as used by the innovator.
excipient compatibility studies? Therefore, compatibility studies were not performed.
16. Have you performed comparative The firm has performed Comparative Studies with
dissolution studies?
Synjardy Tablets 12.5mg
Batch no. 601684
+ 1000mg
Manufactured by M/s Boehringer Ingelheim International

GmbH, Germany. The firm also have actual pack of innovator
products. (Dissolution method reference adopted from US FDA
database).
The firm‘s products show comparable dissolution profile with
innovator product.
17. Do you have product development The firm has dedicated product development (R&D) section
(R&D) section with requisite manufacturing and analysis facilities.
18. Do you have necessary equipment The firm has necessary equipment available in product
available in product development development section for development of Empagliflozin +
section for development of Metformin HCl Tablets 5mg + 500mg & 12.5mg + 1000mg.
Empagliflozin & Metformin HCl
tablets?
19. Are the equipment in product The available equipment in product development section are
development section qualified? qualified.
20. Do you have proper maintenance / The firm has proper maintenance / calibration with re-
calibration / re-qualification qualification program for the equipment used in PD section.
program for the equipment used in
PD section?
21. Do you have qualified staff in The firm has qualified staff in product development section
product development section with with proper knowledge and training in product development.
proper knowledge and training in There are 40 Scientists (Pharmacist & Chemist) working only
product development? in R&D Section.
22. Have you manufactured three The firm has manufactured three stability batches of each
stability batches for the stability strengths of Empagliflozin + Metformin HCl Tablets 5mg +
studies of empagliflozin & 500mg & 12.5mg + 1000mg. Packed in Alu-Alu blisters:
metformin HCl tablets as
required? Empagliflozin + Metformin HCl Tablets
12.5mg + 1000mg
Batch No. Date of Mfg. Batch Size
395DS01 April 2017 1500 Tablets
395DS02 May 2017 1500 Tablets
Empagliflozin + Metformin HCl Tablets

5mg + 500mg
Batch No. Date of Mfg. Batch Size
23. Do you have any criteria for fixing The criteria for fixing the batch size of stability batches is the
the batch size of stability batches? capacity of their R&D equipment where probable simulation of
manufacturing procedure of production batches are expected as
well as quantity of tablets required per testing frequencies.
24. Do you have complete record of The firm has complete record of production of stability
production of stability batches? batches. All the Log Books are properly maintained.
25. Do you have protocols for stability The firm has detailed protocols for stability testing of stability
testing of stability batches? batches having protocol number:

12.5mg + 1000mg
Batch No. Protocol No.
395DS01 FS-066-17
395DS02 FS-067-17
395DS03 FS-068-17

5mg + 500mg
Batch No. Protocol No.
394DS02 FS-069-17
394DS03 FS-070-17
394DS04 FS-071-17
26. Do you have developed and The firm has developed and validated the method for testing of
validated the method for testing of stability batches.
stability batches?
27. Do you have method transfer The firm has developed and validated method of testing for
studies in case when the method of finished product and complete Method Validation Report is
testing being used by your firm is available. Method transfer is not applicable.
given by any other lab?
28. Do you have documents The firm has proper documents confirming the qualification of
confirming the qualification of equipment / instruments being used in the test and analysis of
equipments / instruments being API and the finished drug.
used in the test and analysis of
API and the finished drug?
29. Do your method of analysis The firm has performed forced degradation (FD) study on their
stability indicating? products Empagliflozin + Metformin HCl Tablets 5mg +
500mg & 12.5mg + 1000mg for the conformance of its
stability indicating nature. Further, degradation products are
also analysed during stability studies.
30. Do your HPLC software 21CFR The HPLC software is 21CFR Compliant as per record
Compliant? available with the firm.
31. Can you show Audit trail reports Audit trail on the testing reports is fully available.
on empagliflozin & metformin
HCl testing?
32. Do you have some remaining The firm has remaining quantities of stability batches only.
quantities of degradation products
and stability batches?
33. Do you have stability batches kept The firm has three stability batches kept on real time stability
on stability testing? testing.
34. Do you have valid calibration The firm has valid calibration status for the equipment used in
status for the equipments used in production and analysis of Empagliflozin + Metformin HCl
tablets production and analysis? Tablets 5mg + 500mg & 12.5mg + 1000mg.
35. Do proper and continuous Adequate monitoring and control are available for stability
monitoring and control are chamber. Chambers are controlled and monitored through
available for stability chamber? software having alarm system for alerts as well.
36. Do related manufacturing area, Related manufacturing area, equipment, personnel and utilities
equipment, personnel and utilities are in compliance.
be rated as GMP compliant?
Conclusions:
i. On the basis of risk based approach the genuineness / authenticity of stability data submitted by the
firm for registration of Glardin-M 5mg/500mg and Glardin-M 12.5mg/1000mg (Empagliflozin +
Metformin HCl) Tablets is verifiable to highly satisfactory level.
ii. The related manufacturing area, equipments, personnel and utilities are GMP compliant and well
suited for the manufacturing of Glardin-M 5mg/500mg and Glardin-M 12.5mg/1000mg
(Empagliflozin + Metformin HCl) Tablets.
Decision: Registration Board decided to approve registration of “Glardin-M 5mg/500mg and Glardin-
M 12.5mg/1000mg (Empagliflozin + Metformin HCl) by M/s. Getz Pharma (Pvt.) Limited, 29-30,
Sector-27, Korangi Industrial Area, Karachi. Manufacturer will place first three production batches of
both products on long term stability studies throughout proposed shelf life and on accelerated studies
for six months.
Evaluator-PEC-VI
Sr. No. Name & Address of Brand Name Type of Form, International Previous DRB
Manufacturer / (Proprietary Name + Initial Diary & Availability / Decision /
Applicant Dosage Form + Date, Fee Local Remarks
Strength), (including Availability (if any)
Composition, differential fee),
Pharmacological Demanded Price / GMP
Group, Pack size Inspection
Finished Product Report Date &
868. M/s Sami Pharma Delanzo DR Capsule Form 5D USFDA The firm has
(Pvt) Ltd, Karachi 30mg Approved claimed
Dairy No. 1357 Manufacturer‘s
Each capsule dated 15-2-2018 Lansodex Specifications.
contains: capsules 60mg
Rs.50,000/- dated of GETZ
Dexlansoprazole 14-2-2018 Pharma
delayed release
pellets eq to Last inspection
Dexlansoprazole…… As per Drap report 3-10-
..30mg Policy 2017 firm was
considered to
(Anti-Ulcerative) be operating at
good level of
compliance
with GMP and
has potential
for further
improvement.
Drug Delanzo DR 30mg capsule
Name of Manufacturer M/s Sami Pharmaceuticals, Karachi
Manufacturer of API M/s Alphamed Formulations, India
API Lot No. BVA16001
Description of Pack Alu/Alu
Stability Storage Condition Accelerated: 40°C ± 2°C & 75±5%RH
Real Time: 30°C ± 2°C & 65±5%RH
Time Period Accelerated: 06 Months
Real Time: 06 Months
Frequency Accelerated: 0,1,3,6 (Month)
Real Time: 0,3,6(Month)
Batch No. Lab-01 Lab-02 Lab-03
Batch Size 1,300 capsules 1300 capsules 1300 capsules
Manufacturing Date May – 2017 May-2017 May-2017
Date of Initiation May-2017 May-2017 May-2017
No. of Batches 3
1. COA of API Copy of COA from M/s Alphamed India is submitted.
2. Approval of API by regulatory authority of Copy of GMP Certificate No. L.Dis.
country of origin or GMP certificate of API No.4948/E(M)/TS/2017 issued by Drugs Control
manufacturer issued by regulatory authority Administration, Govt. of telangana is submitted.
of country of origin.
3. Protocols followed for conduction of Yes
stability study and details of tests.
4. Data of 03 batches will be supported by Yes
attested respective documents like
chromatograms, laboratory reports, data
sheets etc.
5. Documents confirming import of API etc. Copy of ADC (Karachi) attested Commercial Invoice
issued by M/s Alphamed formulations, India is
submitted.
6. All provided documents will be attested Yes
(name, sign and stamp) for ensuring
authenticity of data / documents.
7. Commitment to continue real time stability Yes
study till assigned shelf life of the product.
8. Commitment to follow Drug Specification Yes
Rules, 1978.
REMARKS OF EVALUATOR(VI)
● The firm has provided 06 Months Accelerated and 06 Months Real Time Stability Data for 03 Batches.
● COA from Alphamed does not show dissolution testing of pellets at pH 5.5 and 6.75, However they have
submitted separate dissolution testing profile report at both pH.
Decision:
Sr. No. Name & Address of Brand Name Type of Form, International Previous DRB
Manufacturer / (Proprietary Name + Initial Diary & Availability / Decision /
Applicant Dosage Form + Date, Fee Local Remarks
Pharmacological Demanded Price / GMP
Group, Pack size Inspection
869. M/s Sami Pharma Delanzo DR Capsule Form 5D USFDA The firm has
Each capsule dated 15-2-2018 Last inspection Specifications.
contains: report 3-10-
Rs.50,000/- dated 2017 firm was
Dexlansoprazole 14-2-2018 considered to
delayed release be operating at
pellets eq to good level of
Dexlansoprazole…… As per Drap compliance
..60mg Policy with GMP and
has potential
(Anti-Ulcerative)
for further
improvement.
Drug Delanzo DR 60mg capsule
Name of Manufacturer M/s Sami Pharmaceuticals, Karachi
Manufacturer of API M/s Alphamed Formulations, India
Description of Pack Alu/Alu
Stability Storage Condition Accelerated: 40°C ± 2°C & 75±5%RH
Real Time: 30°C ± 2°C & 65±5%RH
Frequency Accelerated: 0,1,3,6 (Month)
Real Time: 0,3,6(Month)
Batch No. Lab-01 Lab-02 Lab-03
Batch Size 1300 capsules 1300 capsules 1300 capsules
Manufacturing Date May – 2017 May-2017 May-2017
Date of Initiation May-2017 May-2017 May-2017
No. of Batches 3
manufacturer issued by regulatory authority Administration, Govt. of telangana is submitted.
sheets etc.
issued by M/s Alphamed formulations, India is
submitted.
Rules, 1978.
● The firm has provided 06 Months Accelerated and 06 Months Real Time Stability Data for 03 Batches.
● COA from Alphamed does not show dissolution testing of pellets at pH 5.5 and 6.75, However they have
submitted separate dissolution testing profile report at both pH.
Decision:
Report on Investigation of Authenticity / Genuineness of data submitted for registration of

Delanzo DR 30mg and 60mg (Dexlansoprazole) Capsules by M/s. Sami Pharmaceutical
(Pvt.) Ltd., F-95, S.I.T.E, Karachi.
Reference No: F.13-11/2017-PEC dated 21st March, 2018.
Investigation Date and Time: 02nd April, 2018 (Evening).
Investigation Site: Factory premises of M/S. Sami Pharmaceutical (Pvt.) Ltd., F-95, S.I.T.E,
Karachi.
Background:
Registration Board meeting considered the applications of M/s. Sami Pharmaceutical

(Pvt.) Ltd., F-95, S.I.T.E, Karachi for registration of Delanzo DR 30mg and 60mg Capsules.
Registration Board considered scientifically rational laboratory scale data submitted by the firm as
pre-requisite of registration being new formulation and constituted a three member panel to
investigate the authenticity / genuineness of data (import of raw material and stability data). Panel
was advised to conduct inspection of the firm as per decision of Registration Board and to submit
report for further consideration.
1. Prof. Dr. Ghulam Sarwar, Dean, Faculty of Pharmacy, Jinnah University for Women, 5-C,
St-1, Nazimabad, Karachi.
3. Dr. Mehwish Tanveer, Assitant Director, DRAP Office, Karachi.
Investigation of the authenticity / genuineness of data (import of raw material and stability
data), manufacturing of stability batches and stability studies on these batches.
The investigation was conducted by using a structured questionnaire of DRAP. For

objective evidence 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 were also audited. The details of investigation may be
summarized as under:
S. No. Questions Remarks
1. Do you have documents confirming the The firm has imported 1.6kg Dexlansoprazole DR
import API including approval from DRAP? 22.5% pellets from M/s. Alphamed Formulations,
India Batch No. BVA 16001. Invoice No. 040/16-
17 and material is cleared by ADC.
2. What was the rationale behind selecting the The firm has performed comparative analysis
particular manufacturer of API? between different suppliers and found M/s.
Alphamed material as per FDA guidelines Impurity
profile of M/s. Alphamed material is better than
other supplier GMP certificate is available. All
these activities / requirements are the part of
vendor selection / qualification program of the
firm.
3. Do you have documents confirming the The firm has imported Dexlansoprazole reference
import of API reference standard and standard and one major impurity standard (Process
impurity standards? impurity and degradation product) from the
manufacturer.
4. Do you have certificate of Analysis of the The firm has certificates of analysis for API,
API, reference standards and impurity reference standard of API and one major impurity
standards? standard.
5. Do you have GMP certificate of APIs The firm has GMP certificate of M/s. Alphamed
manufacturer issued by regulatory authority formulations, India issued by Drug Control
of country of origin? Administration, Government of Telangana, India.
6. Do you use APIs manufacturer method of The firm has used API manufacturer method of
testing for testing APIs? testing.
7. Do you have stability studies reports on API? The firm has stability study reports on API
conducted by the API manufacturer.
8. If yes, whether the stability testing has been Stability testing has been performed as per SIM
performed as per SIM method and method and degradation products have been
degradation products have been quantified? quantified.
9. Do you have method for quantifying the The firm has manufacturer method for quantifying
impurities in the API? the impurities in the API.
10. Do you have some remaining quantities of The firm has remaining quantities of the API, its
the API, its reference standard and impurities reference standard, however, impurity standard has
standards? been exhausted during the studies.
11. Have you used pharmaceutical grade Since the product is filling of already prepared
excipients? granules in gelatin shells, therefore, the only
excipient used is the gelatin shells which are of
pharmaceutical grade as per the COA and related
documents.
12. Do you have documents confirming the The firm has necessary documents confirming the
import of the used excipient? import of the used excipients (Innovator Dexilant
also using same capsule shell).
13. Do you have test reports and other records on The firm has complete test reports and other
the excipients used? records on the excipient (gelatin shells) used.
14. Do you have written and authorized protocols The firm has written and authorized protocol for
for the development of Dexlansoprazole DR the development of Dexlansoprazole DR 30mg and
30mg and 60mg Capsules? 60mg Capsules.
15. Have you performed Drug-excipients Not applicable.
compatibility studies?
16. Have you performed comparative dissolution The firm has performed comparative dissolution
studies? studies with reference product DEXILANT 30mg
and 60mg capsules manufactured by M/s. Takeda,
USA. The dissolution profiles of the firm capsules
are comparable with that of the reference capsules.
17. Do you have product development (R&D) The firm has dedicated area for product
section development (R&D) section.
18. Do you have necessary equipment available The firm has dedicated manufacturing and testing
in product development section for equipment in product development section for the
development of Dexlansoprazole DR 30mg development of capsule formulations.
and 60mg Capsules?
19. Are the equipments in product development The available equipments in product development
section qualified? section are qualified.
20. Do you have proper maintenance / calibration The firm has proper maintenance / calibration / re-
/ re-qualification program for the equipment qualification program for the equipment used in
used in PD section? Product Development section.
21. Do you have qualified staff in product The firm has a team of 10 skilled and qualified
development section with proper knowledge staff in product development section with proper
and training in product development? knowledge and training in product development.
22. Have you manufactured three stability Three stability batches have been manufactured for
batches for the stability studies of stability studies of Dexlansoprazole DR 30mg and
Dexlansoprazole DR 30mg and 60mg 60mg Capsules with batch numbers Lab-01, Lab-
capsules as required? 02 and Lab-03. The batch sizes for all three batches
of both potencies are 1300 Capsules each. The
capsules are packed in AluAlu blisters with pack
size of 2x7s.
23. Do you have any criteria for fixing the batch The criteria for fixing the batch size of stability
size of stability batches? batches is based on the number of Capsules per
testing frequency and the number of testing
frequencies.
24. Do you have complete record of production The firm has complete record of production of
of stability batches? stability batches.
25. Do you have protocols for stability testing of The firm has detailed protocols for stability testing
stability batches? of stability batches.
26. Do you have developed and validated the The firm has performed detailed analytical method
method for testing of stability batches? validation studies for the testing of
Dexlansoprazole DR 30mg and 60mg Capsules.
The analytical method is based upon the method
for API testing for impurities and forced
degradation studies.
27. Do you have method transfer studies in case The firm has conducted complete validation studies
when the method of testing being used by on their analytical method used.
your firm is given by any other lab?
28. Do you have documents confirming the The firm has proper documents confirming the
qualification of equipments / instruments qualification of equipment / instruments being used
being used in the test and analysis of API and in the test and analysis of API and the finished
the finished drug? drug.
29. Does your method of analysis stability The firm method of analysis is stability Indicating
indicating? and supported by spiking and forced degradation
studies.
30. Do your HPLC software 21CFR Compliant? The firm has HPLC software is 21CFR Compliant.
31. Can you show Audit trail reports? The firm has audit trail reports on the testing of the
API and stability batches which were confirmed
physically by the panel.
32. Do you have some remaining quantities of The firm has remaining quantities of stability
degradation products and stability batches? batches only.
33. Do you have stability batches kept on The firm has kept all the three laboratory scale
stability testing? batches of both potencies on real-time stability
testing. The 09 month studies have been
completed.
34. Do you have valid calibration status for the The firm has valid calibration status for the
equipments used in Dexlansoprazole DR equipment used in Dexlansoprazole DR 30mg and
30mg and 60mg Capsules production and 60mg Capsules production and analysis.
analysis?
35. Do proper and continuous monitoring and The firm has adequate monitoring and control are
control are available for stability chamber? available for stability chambers. The
AtmoCONTROL system with data loggers
performed the 24 hours monitoring of the
chambers.
36. Do related manufacturing area, equipment, The related manufacturing area, equipment,
personnel and utilities be rated as GMP personnel and utilities are GMP compliant.
compliant?
37. Any specific instruction / observation by The panel thoroughly reviewed the analytical
the registration board? record including the spectrums performed on two
The panel should conformed analytical different pellets and the finished capsules of both
record for dissolution test alongwith
potencies as per innovator and FDA
respective spectrograms performed on two
different pellets and finished product as per recommendations. It was found that the analytical
innovator and FDA recommendations. procedures, related specifications are as per
innovator and FDA recommendations and the
results of dissolution studies are well acceptable.
Conclusions:
1. On the basis of risk based approach the genuineness / authenticity of stability data
submitted by the firm for registration of Delanzo DR 30mg and 60mg Capsules
(Dexlansoprazole) is verifiable to highly satisfactory level.
2. The related manufacturing area, equipments, personnel and utilities are GMP
compliant and well suited for the manufacturing of Delanzo DR 30mg and 60mg
Capsules.
Decision: Registration Board decided to approve registration of “Delanzo DR 30mg and

60mg Capsule (Dexlansoprazole) by M/s Sami Pharmaceuticals Pvt. Limited,
Karachi. Manufacturer will place first three production batches on long term
stability studies throughout proposed shelf life and on accelerated studies for
six months.
Evaluator PEC-II
Sr. Name & Address of Brand Name Type of Form, International REMARKS
No. Manufacturer / (Proprietary Name Initial Diary & Date, Availability / (IF ANY)
Applicant + Dosage Form + Fee (including Local
Strength), differential fee), Availability
Composition, Demanded Price /
Pharmacological Pack size GMP
Group, Inspection
Finished Product Report Date
Specification & Remarks
870. M/s Martin Dow Ltd. Prolaxit Tablets Form 5-D Approved by The firm has
(Martin Dow 30 mg Diary No. 999 dated USFDA claimed
Pharmaceuticals Each film coated 16-05-2016. Not Manufacturer‘
Limited, Plot No.37, tablet contains: Rs.50,000/- dated 13- applicable. s
Sector 19, Korangi Daclatasvir (as 05-2016. Last GMP Specifications
Industrial Area, dihydrochloride) 14‘s = Rs. 60,643.94/- inspection
Karachi. …… 30mg 28‘s = Rs. was
(Anti-viral) 121,287.88/- conducted
56‘s = Rs. on 08-06-
242,575.76/-
2017 and the
report
concludes
good level
of GMP
compliance.
STABILITY STUDY DATA SUBMITTED INITIALLY
Drug Prolaxit Tablets 30 mg (Daclatasvir as dihydrochloride)
Name of Manufacturer M/s Martin Dow Ltd. (Martin Dow Pharmaceuticals Limited, Plot No.37,
Sector 19, Korangi Industrial Area, Karachi.
Manufacturer of API M/s Nantong Chanyoo Pharmatech Co., Ltd, China
API Lot No. RD-DCL-201608261
Description of Pack Alu-alu blister foil.
Stability Storage Condition Real Time: 30°C ± 2°C / 65% ± 5%RH
Accelerated: 40°C ± 2°C / 75% ± 5%RH
Time Period Real Time: 26 weeks
Accelerated: 26 weeks
Frequency Real Time: 0,1,2,3,4,6,8,12,16,20,24 & 26 (weeks)
Accelerated: 0,1,2,3,4,6,8,12,16,20,24 & 26 (weeks)
Batch No. NPD-T-039-L NPD-T-051-P NPD-T-052-P
Batch Size 2,500 Tablets 2,500 Tablets 2,500 Tablets
No. of Batches 03
DOCUMENTS / DATA PROVIDED BY THE APPLICANT INITIALLY
No.
1. COA of API Yes
2. Approval of API by regulatory authority of
country of origin or GMP certificate of API Approved source as per decision of 275th meeting of
manufacturer issued by regulatory authority Registration Board
3. Protocols followed for conduction of stability
Yes
study and details of tests.
4. Data of 03 batches will be supported by
Yes
sheets etc.
5. Documents confirming import of API etc.
Yes (Copies of invoices attested by ADC, DRAP,
Karachi have been submitted)
6. All provided documents will be attested

(name, sign and stamp) for ensuring Yes
7. Commitment to continue real time stability
Yes
8. Commitment to follow Drug Specification
Yes
Rules, 1978.
REMARKS OF EVALUATOR2
● The firm has provided 06 Months Accelerated and 06 Months Real Time Stability Data for 03 Lab Scale
Batches.
● Firm has stated that initial formulation was tentative as mentioned in submitted dossier. Final formulation
is submitted along with stability studies data.
REQUEST OF EXEMPTION ROM ON SITE INSPECTION
Now the firm has requested for Exemption from On-site Investigation of their submitted stability data vide
Letter no. DRAP/SMI/131/0118, dated 31-01-2018 and provided the following documents in conjunction
with the checklist approved by the Registration Board in its 276th Meeting:
(Date of submission: 06-02-2018 vide diary no. 4311)
Administrative Portion
1. Reference of last onsite panel inspection for Firm has referred to onsite inspection report of
instant dosage form conducted during last their product ―Osvir (Sofosbuvir 400mg) Tablets‖
two years. which was conducted on 25th August, 2016 and was
presented in 262nd meeting of Registration board held
on 20-21st October, 2016 wherein Registration
Board decided to approve registration of Osvir
(Sofosbuvir 400mg) Tablets by M/s. Martin Dow
Ltd, Karachi. Manufacturer will place first three
production batches on long term stability studies
through proposed shelf life and on accelerated
studies for six months.
● Following two observations were reported in the
report:
i.
HPLC software is 21 CFR non-compliant
for API and finished product testing up to
06 months. However, finished product
testing for 09 months was done on HPLC
with 21 CFR compliant software.
ii. Audit trail on the testing reports cannot
be made upto 06 months however,
performance of tests was confirmed from
respective equipment log books. Audit
trail was observed on 09 months testing
on finished product kept at real time
testing.
2. Documents for the procurement of API with Copy of ADC (Karachi) attested Commercial Invoice
approval from DRAP (in case of import). (invoice no. CY116301A) dated 09-12-2016, issued by
M/s Changzhou Pharmaceutical factory, China is
submitted in the name of M/s Martin Dow Ltd.,
Karachi. Quantity of Daclatasvir dihydrochloride
mentioned in invoice is 1.1Kg
3. Documents for the procurement of reference ● The firm has submitted copy of letter from M/s
standard and impurity standards. Neon Chemicals in the name of M/s Martin Dow
Ltd, Karachi, dated 03-01-2017, declaring the
submission of following reference standards on
behalf of their principal i.e. M/s Nantong Chanyoo
Pharmatech Co., Ltd, China.
Particulars Batch No. Quantity

Impurity RD-DCL-4- 10mg
DCL-4 201607181
Impurity RD-DCL-D2- 10mg
DCL-D2 201607141
Impurity RD-DCL-E- 10mg
DCL-E 201607011
DCL-D1 201607051
Working RD-DCL- 10mg
standard 201605101
● The firm has submitted copy of letter from M/s
Neon Chemicals in the name of M/s Martin Dow
DCL-4 201607181
DCL-D2 201607141
DCL-E 201607011
DCL-D1 201607051
Working WDCL01- 5mg
standard 170101
4. Approval of API/ DML/GMP certificate of Approved source as per decision of 275 th meeting of
API manufacturer issued by regulatory Registration Board
authority of country of origin.
5. Mechanism for Vendor pre-qualification The firm has submitted photocopy of ―SOP for
Supplier/Manufacturer Qualification for Raw &
Packaging Material‖, SOP No: COD-005 version no.
09
6. Certificate of analysis of the API, reference ● Photocopy of COAs of Daclatasvir
standards and impurity standards dihydrochloride, of the, reference standards and
impurity standards issued by M/s Nantong
Chanyoo Pharmatech Co., Ltd, China.is submitted.
Detail is as under
Particulars Batch No.

Daclatasvir RD-DCL-
dihydrochloride
201608261
Impurity DCL-4
RD-DCL-4-
201607181
Impurity DCL-D2 RD-DCL-D2-
201607141
Impurity DCL-E RD-DCL-E-
201607011
201607051
Working standard RD-DCL-
201605101
7. Documents for the procurement of excipients The firm has submitted photocopy of Purchase
used in product development? Order/Invoices for the procurement of excipients used
in product development
8. List of qualified staff involved in product The firm has submitted photocopy of List of qualified
development with relevant experience. staff involved in product development comprising of 5
members.
Production Data
9. Authorized Protocols/SOP for the ● The firm has submitted photocopy of ―New
development & stability testing of trial Product Development Protocol‖ (SOP reference
batches. no. NPD-001) filled for Prolaxit Tablet 30mg &
60mg, dated 24-02-2017. The SOP mentions the
details of literature survey, pre-formulation
studies, master formulation & manufacturing
method for Prolaxit tablets.
● Copies of stability protocols have also been
submitted or Prolaxit 30 mg & 60mg tablet.
10. Complete batch manufacturing record of The firm has submitted photocopy of Batch
three stability batches. Production Record and Batch Packaging Record of the
following 03 Batches of Prolaxit 30mg tablets:
Batch No. Batch Size Mfg. Date
NPD-T-039-L 2,500 18-01-2017
Tablets
NPD-T-051-P 2,500 28-02-2017
Tablets
NPD-T-052-P 2,500 28-02-2017
Tablets
● Submitted batch production records include
dispensing sheets, line clearance sheets,
granulation, compression, coating & blistering
records.
11. Record of remaining quantities of stability The firm has reconciliation sheets mentioning details
batches. of all three trial batches of Prolaxit tablets.
QA / QC DATA
12. Record of Digital data logger for temperature The firm has submitted photocopies of hand filled
and humidity monitoring of stability sheets of ―Temperature & Humidity Monitoring
chambers (real time and accelerated) Record‖ for both accelerated & real time stability
studies. Details are as under:
EQ. ID Condition Duration of
Monitoring
record
QC/INS/058 40°C ± 2°C / 75% ± Jan-2017 to
5%RH Dec-2017
QC/INS/057 40°C ± 2°C / 75% ± Jan-2017 to
5%RH Dec-2017
QC/INS/035 30°C ± 2°C / 65% ± Jan-2017 to
5%RH Dec-2017
QC/INS/036 30°C ± 2°C / 65% ± Jan-2017 to
5%RH Dec-2017
● As per decision of 276th meeting Record of Digital

data logger for temperature and humidity
monitoring of stability chambers (real time and
accelerated) shall be submitted for exemptions
from verification of authenticity of submitted
stability data.
●
Upon inquiring firm has submitted as under:
“The climatic chambers at the accelerated
conditions were connected with digital data
recording system and their results are being
shared while the climatic chambers at the long
term conditions did not have this capability.
There we recorded the data manually that had
been shared.
Currently Martin Dow ltd. has procured two
latest climatic chambers (Memmert model#
HPP-1400) these chambers are 21CFR part 11
compliant and have built in digital data
recording system. Now the stability studies at
the long term condition are being conducted on
these new climatic chambers.”
● Firm has submitted digital data report of climatic
chamber at accelerated conditions (Eq. ID FDM
(058), from Feb, 2017 to August, 2017.
13. Method used for analysis of API along with ● The firm has submitted photocopy of raw material
COA. specifications, raw material testing procedures
along with COAs for Daclatasvir dihydrochloride
from M/s Nantong Chanyoo Pharmatech Co., Ltd,
China
● Firm has also submitted photocopies of their own
Analytical report for Daclatasvir dihydrochloride
(Batch#. RDDCL-201608261) & Standard Testing
Method for Daclatasvir dihydrochloride base upon
supplier‘s method.
14. Method used for analysis of FPP & complete Dissolution test parameters mentioned in finished
record of testing of stability batches (i.e. product testing method are different from that
chromatograms, lab reports, raw data sheets recommended by USFDA. Details of differences are as
etc.) under submitted along with stability studies data:
Dissolution US FDA Method

parameter recommended submitted by
method firm
Medium 0.1N HCl Phosphate
Buffer, pH 6.8
with 0.75%
Brij 35
Medium 1000ml 1000ml
volume
Apparatus Paddle Paddle
Time 45 minutes 45 minutes
Upon inquiring firm has submitted that dissolution

test of Daclatasvir was performed on in-house
developed method and the validation of the method
has also been performed.
15. Reports of stability studies of API from The firm has submitted photocopy of 06 Months
manufacturer. Accelerated and 60 Months Real Time Stability Study
Data of 03 Batches of Daclatasvir dihydrochloride
China
16. Analysis reports for excipients used. The firm has submitted photocopies of its own
Analytical reports for all excipients used in product
development of Prolaxit tablets.
17. Drug-excipients compatibility studies. ● The firm has not performed Drug-excipients
compatibility studies and has referred to their
―New Product Development Protocol‖ stating as
under:
―Formulation of Prolaxit 30mg & 60mg tablets will be
developed by using excipients that are being
widely used for solid dosage forms. Excipients are
kept constant as that of the innovators formulation
which are compatible with the API and which each
other. This will also be ensured by satisfactory
stability studies results. Therefore API- Excipient
compatibility studies will not be performed.
18. Record of comparative dissolution data. ● Firm has submitted one page Comparative
Dissolution Report.
● Detail of reference product & sample product is as
under
Feature Reference Product of

product (M/s M/s Hilton
Bristol Mayer’s
Squib)
Brand name Daklinza 60mg Prolaxit 60mg
tablet Tablet
Batch No. AAH8514 NPD-T-044-L
Expiry date 10-2017 02-2019
● CDP has been performed in 0.1N HCl.
● Firm has stated that formulation of Prolaxit
30mg Tablet & Prolaxit 60mg Tablet are same
therefore CDP is performed on Prolaxit 60 mg
tablet only
19. Compliance Record of HPLC software ● Firm has submitted audit trail reports of three
21CFR & audit trail reports on product HPLC systems used in the stability studies
testing. analysis of Prolaxit 30mg tablet & Prolaxit
60mg tablets. Details are as under:
Trial Batch QC/INS/0 QC/INS/ QC/INS/
no. 95 002 003
NPD-T-039- 20th week 0,2,4,12,2 06,08,16th
L 4,26th week
week
NPD-T-051- 0,12,16th 6,8,20,24, 2,4th week
P week 26th week
th
NPD-T-052- 0,12,16 6,8,20,24, 2,4th week
P week 26th week
Decision: Registration Board deferred the case and directed the firm to conduct dissolution test of all
stability batches of prolaxit 30mg tablet as per parameters recommended by USFDA. Moreover Board
decided to constitute two member panel for on-site investigation/verification of following two points:
i. Performance of dissolution test for all three stability batches of Prolaxit 30mg as per parameters
recommended by USFDA
ii. Confirmation of data logging of stability chambers for the Prolaxit 30mg.
Constitution of Panel:
i. Syed Muzaffar Ali Jafri (Member Registration Board)
ii. Affan Ali Qureshi, Assistant Director, CDL, DRAP, Karachi.
No. Manufacturer / (Proprietary Name Initial Diary & Date, Availability / (IF ANY)
Applicant + Dosage Form + Fee (including Local
Group, Inspection
871. M/s Martin Dow Ltd. Prolaxit Tablets Form 5-D Approved by The firm has
(Martin Dow 60 mg Diary No. 1000 dated USFDA claimed
Pharmaceuticals Each film coated 16-05-2016. Not Manufacturer‘
Limited, Plot No.37, tablet contains: Rs.50,000/- dated 13- applicable. s
Sector 19, Korangi Daclatasvir (as 05-2016. Last GMP Specifications
Industrial Area, dihydrochloride) 14‘s = Rs. 66,708.46/- inspection
Karachi. …… 60mg 28‘s = Rs. was
(Anti-viral) 133,416.92/- conducted
56‘s = Rs. 266,833. on 08-06-
84/-
2017 and the
report
concludes
good level
of GMP
compliance.
Drug Prolaxit Tablets 30 mg (Daclatasvir as dihydrochloride)
Name of Manufacturer M/s Martin Dow Ltd. (Martin Dow Pharmaceuticals Limited, Plot No.37,
Sector 19, Korangi Industrial Area, Karachi.
Manufacturer of API M/s Nantong Chanyoo Pharmatech Co., Ltd, China
API Lot No. RD-DCL-201608261
Description of Pack Alu-alu blister foil.
Time Period Real Time: 26 weeks
Frequency Real Time: 0,1,2,3,4,6,8,12,16,20,24 & 26 (weeks)
Batch No. NPD-T-044-L NPD-T-064-P NPD-T-065-P
No. of Batches 03
No.
1. COA of API Yes
country of origin or GMP certificate of API Approved source as per decision of 275th meeting of
manufacturer issued by regulatory authority Registration Board
Yes
4. Data of 03 batches will be supported by
Yes
sheets etc.
Yes (Copies of invoices attested by ADC, DRAP,
Karachi have been submitted)

Yes
Rules, 1978.
Batches.
● Dissolution method as mention in submitted Product testing method is not as recommended by USFDA.
Letter no. DRAP/SMI/131/0118, dated 31-01-2018 and provided the following documents in conjunction
(Date of submission: 06-02-2018 vide diary no. 4311).
1. Reference of last onsite panel inspection for Firm has referred to onsite inspection report of
instant dosage form conducted during last their product ―Osvir (Sofosbuvir 400mg) Tablets‖
two years. which was conducted on 25th August, 2016 and was
presented in 262nd meeting of Registration board held
on 20-21st October, 2016 wherein Registration
Board decided to approve registration of Osvir
(Sofosbuvir 400mg) Tablets by M/s. Martin Dow
Ltd, Karachi. Manufacturer will place first three
production batches on long term stability studies
through proposed shelf life and on accelerated
● Following two observations were reported in the
report:
i. HPLC software is 21 CFR non-compliant
for API and finished product testing up to
06 months. However, finished product
testing for 09 months was done on HPLC
with 21 CFR compliant software.
ii. Audit trail on the testing reports cannot
be made upto 06 months however,
performance of tests was confirmed from
respective equipment log books. Audit
trail was observed on 09 months testing
on finished product kept at real time
testing.
2. Documents for the procurement of API with Copy of ADC (Karachi) attested Commercial Invoice
approval from DRAP (in case of import). (invoice no. CY116301A) dated 09-12-2016, issued by
M/s Changzhou Pharmaceutical factory, China is
submitted in the name of M/s Martin Dow Ltd.,
Karachi. Quantity of Daclatasvir dihydrochloride
mentioned in invoice is 1.1Kg.
3. Documents for the procurement of reference ● The firm has submitted copy of letter from M/s
standard and impurity standards. Neon Chemicals in the name of M/s Martin Dow

Impurity DCL-4 RD-DCL-4- 10mg
201607181
Impurity DCL-D2 RD-DCL-D2- 10mg
201607141
Impurity DCL-E RD-DCL-E- 10mg
201607011
Impurity DCL-D1 RD-DCL-D1- 10mg
201607051
Working standard RD-DCL- 10mg
201605101
● The firm has submitted copy of letter from M/s
Neon Chemicals in the name of M/s Martin Dow
DCL-4 201607181
DCL-D2 201607141
DCL-E 201607011
DCL-D1 201607051
Working WDCL01- 5mg
standard 170101
4. Approval of API/ DML/GMP certificate of Approved source as per decision of 275 th meeting of
API manufacturer issued by regulatory Registration Board
authority of country of origin.
5. Mechanism for Vendor pre-qualification The firm has submitted photocopy of ―SOP for
Supplier/Manufacturer Qualification for Raw &
Packaging Material‖, SOP No: COD-005 version no.
09
6. Certificate of analysis of the API, reference ● Photocopy of COAs of Daclatasvir
standards and impurity standards dihydrochloride, of the, reference standards and
impurity standards issued by M/s Nantong
Chanyoo Pharmatech Co., Ltd, China.is submitted.
Detail is as under
Particulars Batch No.

Daclatasvir RD-DCL-
dihydrochloride 201608261
Impurity DCL-4 RD-DCL-4-
201607181
Impurity DCL-D2RD-DCL-D2-
201607141
Impurity DCL-E RD-DCL-E-
201607011
201607051
Working standard RD-DCL-
201605101
7. Documents for the procurement of excipients The firm has submitted photocopy of Purchase
used in product development? Order/Invoices for the procurement of excipients used
in product development
8. List of qualified staff involved in product The firm has submitted photocopy of List of qualified
development with relevant experience. staff involved in product development comprising of 5
members.
Production Data
9. Authorized Protocols/SOP for the ● The firm has submitted photocopy of ―New
development & stability testing of trial Product Development Protocol‖ (SOP reference
batches. no. NPD-001) filled for Prolaxit Tablet 30mg &
60mg, dated 24-02-2017. The SOP mentions the
details of literature survey, pre-formulation
studies, master formulation & manufacturing
method for Prolaxit tablets.
● Copies of stability protocols have also been
submitted or Prolaxit 30 mg & 60mg tablet.
three stability batches. Production Record and Batch Packaging Record of the
following 03 Batches of Prolaxit 30mg tablets:

NPD-T-039-L 2,500 18-01-2017
Tablets
NPD-T-051-P 2,500 28-02-2017
Tablets
NPD-T-052-P 2,500 28-02-2017
Tablets
●
Submitted batch production records include
dispensing sheets, line clearance sheets,
granulation, compression, coating & blistering
records.
11. Record of remaining quantities of stability The firm has reconciliation sheets mentioning details
batches. of all three trial batches of Prolaxi tablets.
QA / QC DATA
12. Record of Digital data logger for temperature The firm has submitted that clphotocopies of hand
and humidity monitoring of stability filled sheets of ―Temperature & Humidity Monitoring
chambers (real time and accelerated) Record‖ for both accelerated & real time stability
studies. Details are as under:
EQ. ID Condition Duration of
Monitoring
record
QC/INS/058 40°C ± 2°C / 75% ± Jan-2017 to
5%RH Dec-2017
QC/INS/057 40°C ± 2°C / 75% ± Jan-2017 to
5%RH Dec-2017
QC/INS/035 30°C ± 2°C / 65% ± Jan-2017 to
5%RH Dec-2017
QC/INS/036 30°C ± 2°C / 65% ± Jan-2017 to
5%RH Dec-2017
● As per decision of 276th meeting Record of Digital

data logger for temperature and humidity
monitoring of stability chambers (real time and
accelerated) shall be submitted for exemptions
from verification of authenticity of submitted
stability data.
● Upon inquiring firm has submitted as under:
―The climatic chambers at the accelerated
conditions were connected with digital data
recording system and their results are being shared
while the climatic chambers at the long term
conditions did not have this capability. There we
recorded the data manually that had been shared.
Currently Martin Dow ltd. has procured two latest
climatic chambers (Memmert model# HPP-1400)
these chambers are 21CFR part 11 compliant and
have built in digital data recording system. Now
the stability studies at the long term condition are
being conducted on these new climatic chambers.‖
● Firm has submitted digital data report of climatic
chamber at accelerated conditions (Eq. ID FDM
(058), from Feb, 2017 to August, 2017.
13. Method used for analysis of API along with ● The firm has submitted photocopy of raw material
COA. specifications, raw material testing procedures
along with COAs for Daclatasvir dihydrochloride
China
● Firm has also submitted photocopies of their own
Analytical report for Daclatasvir dihydrochloride
(Batch#. RDDCL-201608261) & Standard Testing
Method for Daclatasvir dihydrochloride base upon
supplier‘s method.
14. Method used for analysis of FPP & complete Dissolution test parameters mentioned in finished
record of testing of stability batches (i.e. product testing method are different from that
chromatograms, lab reports, raw data sheets recommended by USFDA. Details of differences are as
etc.) under submitted along with stability studies data:
Dissolution US FDA Method

parameter recommended submitted by
method firm
Medium 0.1N HCl Phosphate
Buffer, pH 6.8
with 0.75%
Brij 35
Medium 1000ml 1000ml
volume
Apparatus Paddle Paddle
● Upon inquiring firm has submitted that dissolution

test of Daclatasvir was performed on in-house
developed method and the validation of the
method has also been performed.
15. Reports of stability studies of API from The firm has submitted photocopy of 06 Months
manufacturer. Accelerated and 60 Months Real Time Stability Study
Data of 03 Batches of Daclatasvir dihydrochloride
China
16. Analysis reports for excipients used. The firm has submitted photocopies of its own
Analytical reports for all excipients used in product
development of Prolaxit tablets.
17. Drug-excipients compatibility studies. ● The firm has not performed Drug-excipients
compatibility studies and has referred to their
―New Product Development Protocol‖ stating as
under:
―Formulation of Prolaxit 30mg & 60mg tablets will be
developed by using excipients that are being
widely used for solid dosage forms. Excipients are
kept constant as that of the innovators formulation
which are compatible with the API and which each
other. This will also be ensured by satisfactory
stability studies results. Therefore API- Excipient
compatibility studies will not be performed.
18. Record of comparative dissolution data. ● Firm has submitted one page Comparative
Dissolution Report.
● Detail of reference product & sample product is as
under

product (M/s M/s Hilton
Bristol Mayer’s
Squib)
Brand name Daklinza 60mg Prolaxit 60mg
tablet Tablet
Batch No. AAH8514 NPD-T-044-L
Expiry date 10-2017 02-2019
● CDP has been performed in 0.1N HCl.

● Firm has stated that formulation of Prolaxit 30mg
Tablet & Prolaxit 60mg Tablet are same therefore
CDP is performed on Prolaxit 60 mg tablet only
19. Compliance Record of HPLC software ● Firm has submitted audit trail reports of three
21CFR & audit trail reports on product HPLC systems used in the stability studies
testing. analysis of Prolaxit 60mg tablets. Details are
as under:
Trial Batch QC/INS/ QC/INS/ QC/INS/

no. 095 002 003
NPD-T-044-L 20th week 0,2,4,12,2 06,08,16th
4,26th week
week
NPD-T-064-P 0,8,12th 2,4,20,24t 6,16,26th
h
week week week
NPD-T-065-P 0,8,12th 2,4,20,24t 6,16,26th
h
week week week
Decision: Registration Board deferred the case and directed the firm to conduct dissolution test of all
stability batches of Prolaxit 60mg tablet as per parameters recommended by USFDA. Moreover Board
decided to constitute two member panel for on-site investigation/verification of following two points:
i. Performance of dissolution test for all three stability batches of Prolaxit 60mg as per parameters
recommended by USFDA
ii. Confirmation of data logging of stability chambers for the Prolaxit 60mg.
Constitution of Panel:
i. Syed Muzaffar Ali Jafri (Member Registration Board)
ii. Affan Ali Qureshi, Assistant Director, CDL, DRAP, Karachi.
Sr. Name & Brand Name Type of Form, International REMARKS

No. Address of (Proprietary Name + Initial Diary & Availability / (IF ANY)
Manufacturer / Dosage Form + Date, Fee Local
Applicant Strength), Composition, (including Availability
Pharmacological Group, differential fee),
Finished Product Demanded Price / GMP
Specification Pack size Inspection
Report Date &
Remarks
872. M/s Helix CANAT Tablets 100mg Form 5-D INVOKANA Decision M-
Pharma (Pvt.) (Fast Track)
by M/s Janssen 245:
Ltd. Each film coated tablet Pharms, USA. Two experts
contains: 05-11-13 recommended
Hakimsons Canagliflozin MS… Not applicable. the product.
House, A-56, 100mg Rs. 150,000/- Prof.
S.I.T.E. GMP compliant Muzammil
(Anti-diabetic) As per PRC for dated 09-02- Najmi also
Karachi. 10‘s 2016. recommended
the product
during the
meeting.
Registration
Board agreed
to above
expert
opinions.
However, the
Board advised
firm to provide
data for
stability
studies
conducted
under zone IV-
A conditions
as per ICH /
WHO
guidelines for
consideration
of Registration
Board.
Drug CANAT Tablets 100mg (Canagliflozin)
Name of Manufacturer M/s Helix Pharma (Pvt.) Ltd. Karachi.
Manufacturer of API M/s Nantong Chanyoo Pharmatech Co., Ltd. China.
API Lot No. RD-CLF-20160928-R1
Description of Pack Alu/Alu Blister Pack
(Container closure
system)
Stability Storage Accelerated: 40°C ± 2°C & 75±5%RH
Condition Real Time: 30°C ± 2°C & 65±5%RH
Frequency Accelerated: 0,1,2,3,6 (Month)
Real Time: 0,3,6 (Month)
Batch No. TF 001 TF 002 TF 003
Batch Size 500 Tablets 500 Tablets 500 Tablets
No. of Batches 03
No.
1. COA of API Copy of COA issued by M/s Nantong Chanyoo
Pharmatech Co., Ltd. China is submitted.
2. Approval of API by regulatory authority of Copy of GMP Certificate issued by Shaoguan Food
country of origin or GMP certificate of API and Drug Administration, China is submitted for M/s
manufacturer issued by regulatory authority of Changzhou Pharmaceutical Factory.
country of origin.
3. Protocols followed for conduction of stability Yes
sheets etc.
is submitted.
Rules, 1978.
PREVIOUS REMARKS OF EVALUATOR1
Batches.
● Copy of GMP Certificate issued by Shaoguan Food and Drug Administration, China is submitted
for M/s Changzhou Pharmaceutical Factory. Whereas COA of API is from M/s Nantong Chanyoo
Pharmatech Co., Ltd. China.
DECISION 275th RB MEETING
Registration Board was apprised of the following Regulations for Implementation of the Drug Administration
Law of the People‘s Republic of China:
Chapter I General Provisions; Article 5:
The drug regulatory department of the people‘s government at or above the provincial level shall organize
inspections of drug manufacturers in accordance with the Good Manufacturing Practice for Pharmaceutical
Products (GMP) and the measures and schedule for implementing the GMP formulated by the drug
regulatory department under the State Council, and issue a certificate to the manufacturer that complies with
the GMP. For the manufacturer producing injections or radioactive pharmaceuticals and for that producing
biological products specified by the drug regulatory department under the State Council, the inspection of
which shall be conducted by the drug regulatory department under the State Council. The format of GMP
certificate shall be uniformly provided for by the drug regulatory department under the State Council.
Decision of 274th Meeting: Registration Board deferred the case for submission / clarification of GMP
Certificate as it is not issued by respective province / state in light of above regulations.
Decision of 275th Meeting: Registration Board deliberated that it has been decided that onsite
inspection for verification of data will be exempted as decided in instant meeting. Thus the Board
decided as follows:
associated documents, import of API, quality, specification, test analysis, facilities etc
● Dr. Rafeeq Alam Khan, Meritorious Professor / Member Registration Board.
● Dr. Obaidullah, Additional Director (PE&R), DRAP, Islamabad.
● Additional Director DRAP, Islamabad
OR
Firm can submit requisite documents as decided in instant meeting in Case No. 02 (On site
investigation of submitted data).
Sr. Name & Brand Name Type of Form, International REMARKS

No. Address of (Proprietary Name + Initial Diary & Availability / (IF ANY)
Manufacturer / Dosage Form + Date, Fee Local
Applicant Strength), Composition, (including Availability
Pharmacological Group, differential fee),
Finished Product Demanded Price / GMP
Specification Pack size Inspection
Report Date &
Remarks
873. M/s Helix CANAT Tablets 300mg Form 5-D INVOKANA Decision M-
Pharma (Pvt.) (Fast Track) by M/s Janssen 245:
Ltd. Each film coated tablet Pharms, USA. Two experts
contains: 05-11-13 recommended
Hakimsons Canagliflozin MS… Not applicable. the product.
House, A-56, 300mg Rs. 150,000/- Prof.
S.I.T.E. GMP compliant Muzammil
(Anti-diabetic) As per PRC for dated 09-02- Najmi also
Karachi. 10‘s 2016. recommended
the product
during the
meeting.
Registration
Board agreed
to above
expert
opinions.
However, the
Board advised
firm to provide
data for
stability
studies
conducted
under zone IV-
A conditions
as per ICH /
WHO
guidelines for
consideration
of Registration
Board.
Drug CANAT Tablets 300mg (Canagliflozin)
Name of Manufacturer M/s Helix Pharma (Pvt.) Ltd. Karachi.
Manufacturer of API M/s Nantong Chanyoo Pharmatech Co., Ltd. China.
API Lot No. RD-CLF-20160928-R1
Description of Pack Alu/Alu Blister Pack
(Container closure
system)
Frequency Accelerated: 0,1,2,3,6 (Month)
Batch No. TF 001 TF 002 TF 003
No. of Batches 03
No.
1. COA of API Copy of COA issued by M/s Nantong Chanyoo
Pharmatech Co., Ltd. China is submitted.
2. Approval of API by regulatory authority of Copy of GMP Certificate issued by Shaoguan Food
country of origin or GMP certificate of API and Drug Administration, China is submitted for M/s
manufacturer issued by regulatory authority of Changzhou Pharmaceutical Factory.
country of origin.
3. Protocols followed for conduction of stability Yes
sheets etc.
5. Documents confirming import of API etc. Copy of GMP Certificate issued by Shaoguan Food
and Drug Administration, China is submitted for M/s
Changzhou Pharmaceutical Factory.
Rules, 1978.
PREVIOUS REMARKS OF EVALUATOR1
Batches.
● Copy of GMP Certificate issued by Shaoguan Food and Drug Administration, China is submitted for M/s
Changzhou Pharmaceutical Factory. Whereas COA of API is from M/s Nantong Chanyoo Pharmatech
Co., Ltd. China.
DECISION 275TH RB MEETING
Registration Board was apprised of the following Regulations for Implementation of the Drug Administration
Law of the People‘s Republic of China:
Chapter I General Provisions; Article 5:
The drug regulatory department of the people‘s government at or above the provincial level shall organize
inspections of drug manufacturers in accordance with the Good Manufacturing Practice for Pharmaceutical
Products (GMP) and the measures and schedule for implementing the GMP formulated by the drug
regulatory department under the State Council, and issue a certificate to the manufacturer that complies with
the GMP. For the manufacturer producing injections or radioactive pharmaceuticals and for that producing
biological products specified by the drug regulatory department under the State Council, the inspection of
which shall be conducted by the drug regulatory department under the State Council. The format of GMP
certificate shall be uniformly provided for by the drug regulatory department under the State Council.
Decision of 274th Meeting: Registration Board deferred the case for submission / clarification of GMP
Certificate as it is not issued by respective province / state in light of above regulations.
Decision of 275th Meeting: Registration Board deliberated that it has been decided that onsite
inspection for verification of data will be exempted as decided in instant meeting. Thus the Board
decided as follows:
associated documents, import of API, quality, specification, test analysis, facilities etc
● Dr. Rafeeq Alam Khan, Meritorious Professor / Member Registration Board.
● Dr. Obaidullah, Additional Director (PE&R), DRAP, Islamabad.
● Additional Director DRAP, Islamabad
OR
Firm can submit requisite documents as decided in instant meeting in Case No. 02 (On site
investigation of submitted data).
Letter No. 1857 (R&I) dated 15-01-2018 and provided the following documents in conjunction with the
checklist approved by the Registration Board in its 276th Meeting.
1. Reference of last onsite panel inspection for ● Registration Board approved RAMELTON Tablets
instant dosage form conducted during last 8mg (Ramelteon) in its 273rd Meeting.
two years. o Date of Inspection: 18-08-2017.
o The HPLC is 21CFR Compliant.
o Audit trail on the testing reports of ―Ramelton
(Ramelteon) Tablets 8mg were available.
2. Documents for the procurement of API with The firm has submitted photocopies of ADC (Karachi)
approval from DRAP (in case of import). attested Form 6 dated 29-12-2016, Commercial Invoice
dated Nov 30, 2016 for 0.75kg Canagliflozin
Hemihydrate.
● Commercial Invoice is issued by M/s Changzhou
Pharmaceutical Factory, China. Moreover detail
of Batch NO. RD-CLF-20160928-R1 is
mentioned on invoice.
● Form – 3 and Form-6 depicts manufacturing
from M/s Nantong Chanyoo Pharmatech Co.,
Ltd. China.
3. Documents for the procurement of reference ● Not provided.
standard and impurity standards. ● The firm has clarified that the reference
standard and impurity standards are procured
along with the APIs’ consignment and not
separately.
4. Approval of API/ DML/GMP certificate of Cases pertaining to GMP of M/s Nantong Chanyoo
API manufacturer issued by regulatory Pharmatech Co., Ltd. China were discussed in 275th
authority of country of origin. RB Meeting and were granted approval.
5. Mechanism for Vendor pre-qualification ● The firm has submitted copy of vender evaluation
questionnaire for vender pre-qualification.
6. Certificate of analysis of the API, reference ● Canagliflozin API:
standards and impurity standards Photocopy of COA of Batch No. RD-CLF-
20160928-R1 issued by M/s Nantong Chanyoo
Pharmatech Co., Ltd China is submitted.
● Reference standards and impurity standards:
The firm has submitted copy of Working Standards
(Canagliflozin hemihydrates) and impurity
standards provided by the API Manufacturer - M/s
Nantong Chanyoo Pharmatech Co., Ltd. China.
7. Documents for the procurement of Firm has submitted copy of commercial invoices for the
excipients used in product development? excipients used in the applied formulation. However
ADC Clearance is missing on the invoices.
8. List of qualified staff involved in product Firm has submitted copy of R&D staff list comprising of
development with relevant experience. 02 members. Asst. Manager Production (Pharm.D.) - 08
Years and Production Pharmacist (Pharm.D.) - 06
Months.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted copy of generalized SOP with
development & stability testing of trial the title ‗Protocol For Development Of New Product‘.
batches. Effective date 01-03-2017.
10. Complete batch manufacturing record of The firm has submitted copy of Trial batch
three stability batches. manufacturing record. Details are as under:
CANAT Tablet 300mg

Batch Bach size Mfg. Mfg.
No. Started Completed
TF001 500 Tabs 16-01-2017 17-01-2017
TF002 500 Tabs 16-01-2017 17-01-2017
TF003 500 Tabs 16-01-2017 17-01-2017
CANAT Tablet 100mg

Batch Bach size Mfg. Mfg.
No. Started Completed
TF001 500 Tabs 13-01-2017 14-01-2017
TF002 500 Tabs 13-01-2017 14-01-2017
TF003 500 Tabs 13-01-2017 14-01-2017
11. Record of remaining quantities of stability CANAT Tablet 300mg
batches. ● TF001: Yield 490 Tablets, 05 Packs used for testing
method validation. 44 Packs placed on stability out
of which 20 packs are remaining.
● TF002: Yield 486 Tablets, 05 Packs used for testing
CANAT Tablet 100mg
●
TF002: Yield 482 Tablets, 05 Packs used for testing
QA / QC DATA
12. Record of Digital data logger for ● Previously Reported in panel inspection:
temperature and humidity monitoring of The firm has installed software for recording the
stability chambers (real time and temperature/Humidity of the chamber (for real time
accelerated) stability software V5.7T Thermo, India & for
Accelerated Stability studies, software is Logit Chrt;
Technoman; Pakistan) & the data can been verified for
01 year.
Now the firm has submitted copy of record of digital
data logger (Logit Chart, Technoman) for temperature
and humidity monitoring of stability chambers from 12-
02-2017 to 20-06-2017.
13. Method used for analysis of API along with ● The firm has submitted photocopy of method used
COA. for analysis of API (Canagliflozin hemihydrate)
along with COA.
14. Method used for analysis of FPP & complete ● The firm has submitted photocopy of Finished
record of testing of stability batches (i.e. Product Specifications and Testing Method of
chromatograms, lab reports, raw data sheets CANAT Tablet 100mg and 300mg.
etc.) ● Complete record of testing of stability batches (i.e.
chromatograms, lab reports, raw data sheets etc.) are
submitted with the stability data submission as
discussed earlier.
15. Reports of stability studies of API from The firm has submitted copy of accelerated, 03 Months
manufacturer. (40°C ± 2°C & 75±5%RH) & long term, 03 Months
(25°C ± 2°C & 60±5%RH) stability study reports of 03
batches of Canagliflozin hemihydrate from M/s Nantong
Chanyoo Pharmatech Co., Ltd. China.
16. Analysis reports for excipients used. The firm has submitted copy of COAs for the excipients
used in the applied formulation.
17. Drug-excipients compatibility studies. ● The firm has not submitted Drug-excipients
compatibility studies and has referred to the
Innovator Product (INVOKANA).
18. Record of comparative dissolution data. ● Firm has submitted Comparative dissolution study
of their product (CANAT 300mg and 100mg) with
INVOKANA of JANSSEN PHARMS conducted on
06-10-2017 and 27-09-2017. The details are as
follows:

Product HELIX
Pharma
Brand name INVOKANA CANAT 300mg
Batch No. Not Mentioned TF001
Mfg. date Not Mentioned 01-2017
Product HELIX
Pharma
Brand name INVOKANA CANAT 100mg
Batch No. Not Mentioned TF001
Mfg. date Not Mentioned 01-2017
●
Comparative dissolution studies have been
performed in following media:
i. pH 1.2 HCl solution.
ii. pH 4.5 Acetate buffer solution.
iii. pH 6.8 phosphate buffer solution.
iv. 0.75% SLS in water.
● Copy of Calculation Sheets and HPLC
chromatograms has been submitted for Comparative
dissolution studies.
19. Compliance Record of HPLC software The firm has submitted copy of Audit Trail for Initial,
21CFR & audit trail reports on product 3rd and 6th Month Testing Intervals of CANAT 100mg
testing. and 300mg Tablets dated 1/18/2017, 4/22/2017 and
7/24/2017.
th
Decision of 279 meeting: Registration Board deferred the case for clarification the firm has submitted copy
of accelerated, 03 Months only(40°C ± 2°C & 75±5%RH) & long term, 03 Months only (25°C ± 2°C &
60±5%RH) stability study reports of 03 batches of Canagliflozin hemihydrate from M/s Nantong Chanyoo
Pharmatech Co., Ltd. China.
Fresh Evaluation:
Firm has now submitted copy of accelerated, 06 Months only(40°C ± 2°C & 75±5%RH) & long term, 09
Months (30°C ± 2°C & 65±5%RH) stability study reports of 03 batches of Canagliflozin hemihydrate from
M/s Nantong Chanyoo Pharmatech Co., Ltd. China.
Decision of 281st meeting: Registration Board decided to approve registration of “Canat Tablets 300mg
& Canat tablets 100mg (Canagliflozin) by M/s Helix Pharma (Pvt.) Ltd. Karachi. Manufacturer will
place first three production batches of both products on long term stability studies throughout
proposed shelf life and on accelerated studies for six months.
Case No. 9 Registration applications of import cases:
a. Import routine cases (Human)

Evaluator PEC-V
874. Name and address of Applicant M/s The Searle Company Limited,
1st floor, N.I.C.L building Abbasi Shaheed Road, Karachi
Detail of Drug Sale License Address: The Searle company limited, F-319, S.I.T.E., Karachi
Validity: 15/05/2019
Status: Drug sale license by the way of wholesale
Name and address of manufacturer Manufacturer of vials:
M/s Jiangsu Kingsley Pharmaceutical Co., Ltd., No. 18, Chaquan
Road, Central Branch Park, Yixing, Jiangsu, China.
Repacking and addition of solvent:
The Searle Company Limited, F-319, S.I.T.E, Karachi
Name and address of marketing M/s Jiangsu Kingsley Pharmaceutical Co., Ltd., No. 18, Chaquan
authorization holder Road, Central Branch Park, Yixing, Jiangsu, China
Name of exporting country China
Type of Form Form 5-A
Diary No. & Date of R& I Dy. No.3535 Dated 22/12/2016
Fee including differential fee Rs. 100,000/- Dated 22/12/2016
Brand Name +Dosage Form + SELANZ Injection IV 30mg
Strength (Powder for solution for injection)
Lansoprazole…….. 30mg
Finished Product Specification In House
Pharmacological Group Drugs For Peptic Ulcer And Gastro-Oesophageal Reflux Disease
(GORD)
Proton pump inhibitors
ATC Code: A02BC03
Shelf life 36 months
Demanded Price As per DPC
Pack size A pack of 01 vial and 1 sterile water for injection ampoule of 5ml
International availability Prevacid IV Injection, Takeda Pharmaceuticals USA, (USFDA
approved)
Me-too status Belenz Injection 30mg by M/s Wellborn Pharmachem Hattar.
(Reg#054894)
Detail of certificates attached Original legalized CoPP
Certificate No. WX2016007
Certifying Authority: Certified by Jiangsu Province Food and
Drug Administration, China.
Issue Date: 04/03/2016
Validity: 2 Years
Free sale: Confirms the free sale of the product in exporting
country.
GMP: The facilities and operations conform to WHO-GMP.
Remarks of the Evaluator. The firm has claimed In House specifications and the product is not
present in USP/BP.
Decision:
Approved, as per Policy for inspection of Manufacturer abroad. Registration letter will be issued
after the submission of valid original legalized CoPP since the provided Copp has been expired.
875. Name and address of Applicant M/s The Searle Company Limited,
1st floor, N.I.C.L building Abbasi Shaheed Road, Karachi
Detail of Drug Sale License Address: The Searle company limited, F-319, S.I.T.E., Karachi
Status: Drug sale license by the way of wholesale
Name and address of manufacturer M/s DEVA Holding A.S Cerkezkoy Organize Sanayi Bolgesi
Karaagac Mah., Ataturk Cad, No:32 Kapakli-Tekirdag/Turkey
Name and address of marketing M/s DEVA Holdings A.S. Halkah Merkez Mah. Basin Ekpres
authorization holder Cad. No:134303 Kucukcekmece-Istanbul/Turkey.
Name of exporting country Turkey
Brand Name +Dosage Form + ROLASTYM COMBI 400 mcg+12 mcg capsule with Inhalation
Strength powder
(DPI for Inhalation)
Composition Each DPI Capsule contains:
Budesonide…………………………….………… 400mcg
Formoterol fumarate dihydrate (micronized)……. 12mcg
Pharmacological Group Corticosteroid + Long acting beta-2 agonist
Demanded Price As per DPC
Pack size With plastic inhaler device (aerolizer)
International availability Could not be confirmed.
Me-too status N/A
Detail of certificates attached ● Original legalized CoPP (certificate No. 2017/1193) certified
by Turkish Medicines and Medical Devices Agency, valid up
to 02/05/2019 confirms the free sale of the product in
exporting country. The facilities and operations conform to
GMP as recommended by WHO.
Remarks of the Evaluator. The firm has claimed In House specifications and the product is
not present in USP/BP.
Firm has submitted stability according to zone IV B .
Firm has submitted reply thrice and is still deficient for the
following reasons:
● Significant change that is more than 5% variation and
out of specification has been observed at long term
stability studies at 30C/75%RH and at accelerated
stability studies at 40C/75%.Results are provided in the
table below:
● Assay Limits: 90-110%
Batch No. A038201 A038200 A038199
Initial Result (Budesonide) (Budesonide) (Budesonide)

102.10 100.82 100.82
(Formoterol) (Formoterol) (Formoterol)
98.33 99.17 97.50
Long term 18 month 18 month 18 month

stability (Budesonide) (Budesonide) (Budesonide)
studies: 110.31% 107.99% 108.32%
(Formoterol) (Formoterol) (Formoterol)
(30°C/75%R
110.31% 103.33% 106.94%
H)
Accelerated 3 month 3 month Within Limits
stability (Budesonide) (Budesonide) no significant
studies: 103.55% 107.16% change
(Formoterol) (Formoterol)
90.7% 94.42%
● This product is approved by reference country as

powder contained in an inhaler device while the applied
product is a capsule containing powder of inhalation.
Decision:
Deferred for clarification as submitted data shows significant change that is more than 5%
variation and out of specification has been observed at long term stability studies at
300C/75%RH
876. Name and address of Applicant M/s Nasir Brothers,

22-B, 2nd floor Zeenat medicine market, Karachi
Address: Nasir Brothers, 22-B, 2nd floor Zeenat medicine market,
Karachi
Status: Drug license by the way of wholesale
Name and address of M/s Shanxian Runte Medical Instruments Co., Ltd., Nauduan
manufacturer Wenhua Road, Shan County, Heze City, Shandong, China
Name and address of marketing M/s Shanxian Runte Medical Instruments Co., Ltd., Nauduan
authorization holder Wenhua Road, Shan County, Heze City, Shandong, China
Diary No. & Date of R& I Dy. No. 705 Dated 09/02/2017
Brand Name +Dosage Form + Suicon Surgical Sutures Chromic Catgut With Needle
Strength
Composition Disposable Chromic Catgut Surgical Sutures With Needle
Pharmacological Group -------
Shelf life 5 years
Demanded Price Decontrolled
Pack size 12‘s, Al Foil Pouch
International availability Chromic catgut surgical suture by Ethicon INC. USFDA
Me-too status Cosmed pharma Karachi
Detail of certificates attached ● ISO certificate 13485 valid till 23/11/2018
● Copy of certificate of compliance
● Legalized (Embassy attested) certificate for exportation of
medical products (certificate No. hzfdackzm20150020)
issued on 16/11/2015 confirms that the products are allowed
to be sold in China.
● Validity 2 years
Remarks of the Evaluator: The submitted certificate for exportation of medical products is
invalid.
Dimensions of Sutures: (as per certificate of exportation)
Models:
USP Suture size: 12-0, 11-0, 10-0, 9-0, 8-0, 7-0, 6-0, 5-0, 4-0, 3-0,
2-0, 0, 1, 2, 3, 4, 5
Needle Shape: Round Bodies, Straight, Cutting, Reverse cutting
Needle curvature: ½ circle, 3/8 circle, Straight.
Decision:
Approved, as per Policy for inspection of Manufacturer abroad. Registration letter will be
issued after the submission of valid original legalized free sale certificate since the provided
free sale certificate has been expired.
877. Name and address of Applicant M/s Nasir Brothers,
22-B, 2nd floor Zeenat medicine market, Karachi
Drug Sale License Address: Nasir Brothers, 22-B, 2nd floor Zeenat medicine market,
Karachi
Status: Drug license by the way of wholesale
Name and address of M/s Shanxian Runte Medical Instruments Co., Ltd., Nauduan
manufacturer Wenhua Road, Shan County, Heze City, Shandong, China
Name and address of marketing M/s Shanxian Runte Medical Instruments Co., Ltd., Nauduan
authorization holder Wenhua Road, Shan County, Heze City, Shandong, China
Brand Name +Dosage Form + Suicon Surgical Sutures Silk Braided With Needle
Strength
Composition Disposable Surgical Sutures Silk Braided With Needle
Pharmacological Group -------
Shelf life 5 years
Pack size 12‘s, Al Foil Pouch
International availability Chromic catgut surgical suture by Ethicon INC. USFDA
Me-too status Cosmed pharma Karachi
Detail of certificates attached ● ISO certificate 13485 valid till 23/11/2018
● Copy of certificate of compliance
● Legalized (Embassy attested) certificate for exportation of
medical products (certificate No. hzfdackzm20150020)
issued on 16/11/2015 confirms that the products are allowed
to be sold in China.
● Validity 2 years
Remarks of the Evaluator: The submitted certificate for exportation of medical products is
invalid.
Dimensions of Sutures: (as per certificate of exportation)
Models:
USP Suture size: 12-0, 11-0, 10-0, 9-0, 8-0, 7-0, 6-0, 5-0, 4-0, 3-0,
2-0, 0, 1, 2, 3, 4, 5
Needle Shape: Round Bodies, Straight, Cutting, Reverse cutting
Needle curvature: ½ circle, 3/8 circle, Straight.
Decision:
issued after the submission of valid original legalized free sale certificate since the provided
free sale certificate has been expired.
b. Import routine cases (Veterinary)

Evaluator PEC-V
878. Name and address of Applicant M/s Mustafa Brothers,

186-D, Peoples Colony No.1, Faisalabad.
Detail of Drug Sale License Address: M/s Mustafa Brothers,
186-D, Peoples Colony No.1, Faisalabad.
Validity: 12-02-2019
Status: License to sell drugs as a distributor
Name and address of manufacturer M/s Cenavisa, S.L. Cami Pedra Estela, s/no, Reu, 43205
Tarragona, Espana/Spain.
Name and address of marketing M/s Cenavisa, S.L. Cami Pedra Estela, s/no, Reu, 43205
authorization holder Tarragona, Espana/Spain.
Name of exporting country Spain
Brand Name +Dosage Form + CENFROSAL Oral Solution
Strength (for Poultry)
Vitamin B1……… 2.5mg
Nicotinamide……. 8.0mg
Methenamine…... 400mg
Calcium Pantothenate……….. 8.0mg
Pharmacological Group Vitamins/antibacterials
Shelf life 3 years
Demanded Price 4.5 €/L
Pack size Bottle of 100ml, 250ml, 500ml, 1litre, 5 litre
International availability Could not be confirmed
Detail of certificates attached ● Original legalized CoPP (certificate No. 14635/2014)
certified by Agencia espanola De Medicamentos Y
Productos Sanitarios, Spain issued on 10/09/2014 describes
that the facilities and operations conform to GMP as
recommended by WHO.
Remarks of the Evaluator. ● The product is neither licensed nor available in the market
of exporting country for free sale.
● Submission of stability data as per zone IVA missing.
● Evidence of approval in reference regulatory authorities and
Me too could not be confirmed.
Decision: Deferred for the following reasons:
 Evidence of applied formulation/drug already approved by DRAP (generic / me-too
status) along with registration number, brand name and name of firm.
 Evidence of approval of applied formulation in reference regulatory
authorities/agencies which were declared/approved by the Registration Board.
 Submission of list of countries in which applied product is exported other than
Pakistan.
 Submission of stability data as per zone IVA condition.
c. Import Deferred cases
i. Human
Evaluator PEC-V
879. Name and address of Applicant M/s Gene-Tech Laboratories,
Head Office. 246/B, PECHS, Block-6, Karachi, Pakistan
Detail of Drug Sale License Address: M/s Gene-Tech Laboratories, 246/B, PECHS, Block-
6, Karachi,
Status: Drug licence by way of wholesale
Name and address of manufacturer M/s Nanjimg Hencer Pharmaceutical Co.ltd., No.18 Jichang
Road, Lishui Economic & Technical Development zone,
Nanjing City, Jiangsu province, China
Name and address of marketing M/s Nanjimg Hencer Pharmaceutical Co.ltd., No.18 Jichang
authorization holder Road, Lishui Economic & Technical Development zone,
Nanjing City, Jiangsu province, China
Brand Name +Dosage Form + GENOFER IV injection 100mg/5ml
Strength Solution for injection
Iron sucrose Eq. to Elemental Iron…… 100mg
Pharmacological Group Hematinic/Iron supplement
Shelf life 03 years
Demanded Price Rs. 1353/- per pack of 5 ampoules
Pack size 5×1‘s (5ml ampoule)
International availability VENOFER® 5ml injection by M/s Luitpold Pharmaceuticals,
Inc, Health Canada Approved
Me-too status Ferrix injection by M/s Aulton Pharma (Reg # 080558)
Detail of certificates attached ● Original legalized CoPP (certificate No. 2015-14) certified
by Jiang su Provincial Food and Drug Administration valid
till 16/08/2015 confirms the free sale of the product in
exporting country. The facilities and operations conform to
GMP as recommended by WHO as per CoPP.
● Free sale certificate (expired)
● GMP certificate valid till 08/04/2018
Remarks of the Evaluator. ● The firm has claimed In House specifications while the
product is present in USP and B.P.
● CoPP free sale certificate are expired but these were valid
at the time submission of dossier.
Previous Decision ● Deferred for the submission of original, legalized and
Valid CoPP.
Fresh Evaluation
● Original legalized CoPP
Certificate No. NJ2017018-1
Certifying Authority: Jiang su Provincial Food and Drug Administration
Issue date: 06/11/2017
Validity: 8-April-2018
Free sale: Confirms the free sale of the product in exporting country.
GMP: The facilities and operations conform to WHO-GMP.
Decision:
Approved as per Policy for inspection of Manufacturer abroad.
ii. Veterinary
Evaluator PEC-V
880. Name and address of Applicant M/s. Creed Pharmaceuticals, House No.CB83, Street
No.02, Shally Balley, Range Road Saddar, Rawalpindi
Drug sale License Address: M/s Creed Pharmaceuticals, House No.CB83,
Street No.02, Shally Balley, Range Road Saddar,
Rawalpindi
Validity:04/04/2019
Status: Licence to sell drugs as ―Distributor‖.
Name and address of manufacturer M/s. Hebei Hope Harmony Pharmaceutical Co., Ltd.
Industry Development Area, Yuanshi County,
Shijiazhuang City, Hebei Province, People‘s Republic of
China
Name and address of Product License M/s. Hebei Hope Harmony Pharmaceutical Co., Ltd.
Holder Industry Area, Yuanshi County, Shijiazhuang City, Hebei
Province, People‘s Republic of China
Exporting Country China
Brand Name +Dosage Form + Strength Ener 10% Oral Solution
Diary No. Date of R& I & fee Dy No. 59: 29-01-2015 Rs.100,000/-: 29-01-2015
Enrofloxacin………….100mg
Pharmacological Group Antibiotics
Finished Product Specification Firm has claimed in house specifications
Shelf life 2 Years
Pack size & Demanded Price 100ml: Rs. 410/-
500ml: Rs. 1570/-
1000ml: Rs. 2730/-
Approval status of product in Reference ● Baytril 100mg/ml oral solution by Bayer
Regulatory Authorities. (Netherland Approved)
Me-too status Kenflox 10% oral liquid by Better traders (Import)
CoPP/GMP status Copy of free sale certificate confirms free sale availability
in china.
Copy of GMP certificate valid till 23-02-2019 confirms
the GMP of manufacturing facility
Remarks of the Evaluator. ● Firm has claimed in house specification while the
product monograph is available in USP
● Real time stability study is conducted at 25±2oC and 60
±10% RH which is not according to the conditions of
Zone IV-A.
Previous decision (M-272) ● Deferred for submission of real time stability study data
conducted at 30±2°C and 65±5%RH and finished
product specifications as per the monograph available
in USP.
Fresh Evaluation ● Firm has submitted real time stability study data
conducted at 30±2oC and 65±5%RH
● Finished product specifications as per the monograph
of oral suspension available in USP.
Decision:
Approved as per Policy for inspection of Manufacturer abroad. Registration Board
directed the firm to select one fill volume for applied formulation and Board authorized
its Chairman for the issuance of registration letter.
Rawalpindi
Validity:04/04/2019
China
Brand Name +Dosage Form + Strength Oxipro 20% injection
Rs.100,000/-: 29-01-2015
Oxytetracycline dihydrate (as oxytetracycline)…200mg
Shelf life 3 years supported by real-time stability data
Pack size & Demanded Price 50ml
100ml
Approval status of product in Reference ● Tridox Pro Injection by Eurovet animal health
Regulatory Authorities. (Netherland Approved)
Me-too status Tridox L.A Injection by Prix Pharma
CoPP/GMP status Copy of free sale certificate confirms free sale availability
in china
Copy of GMP certificate valid till 23-02-2019 confirms
Remarks of the Evaluator. ● Firm has claimed in house specification without
providing documents as per the requirement of 267th
RB meeting.
● Firm has claimed 3 years shelf life while the shelf life
of product approved by Netherland is 6 months, while
the shelf life approved by France is 2 years.
Previous decision (M-272) ● Deferred for clarification since the firm has submitted
the stability data for claim of 3 years shelf life while the
shelf life of the product approved by reference
regulatory authorities i.e. Netherland and France is only
6 months and 2 years respectively.
Fresh Evaluation ● Firm has revised shelf life from 3 years to 2 years.
Decision
Approved with Innovator’s specifications with a shelf life of 2 years as per Policy for
inspection of Manufacturer abroad.
Registration Board directed the firm to select one fill volume for applied formulation and
Board authorized its Chairman for the issuance of registration letter.
Rawalpindi
Validity:04/04/2019
China
Brand Name +Dosage Form + Strength Oxipro 5% Injection
Rs.100,000/-: 29-01-2015
Oxytetracycline…………50 mg
Shelf life 3 Years
Pack size & Demanded Price 50ml
100ml
250ml
500ml
Approval status of product in Reference ● Acti-Tetra I Injection by Laboratories Biove
Regulatory Authorities. (France Approved)
● copy of free sale certificate confirms free sale
availability in china
Me-too status Yzoxytera 5% injection by Ghazi brothers
CoPP/GMP status Copy of GMP certificate valid till 23-02-2019 confirms
Remarks of the Evaluator. ● Firm has claimed shelf life of 3 years while the shelf
life of product approved by France is 18 months.
● Firm has claimed in house specification without
providing documents as per the requirement of 267th
RB meeting
Previous decision (M-272) ● Deferred for clarification since the firm has submitted
data for claim of 3 years shelf life while the shelf life of
the product approved by reference regulatory authority
viz. France is 2 years.
Fresh Evaluation ● Firm has revised shelf life from 3 years to 18 months.
Decision:
Approved with Innovator’s specifications with a shelf life of 18 months as per Policy for inspection
of Manufacturer abroad.
Registration Board directed the firm to select one fill volume for applied formulation and Board
Case No. 10 Registration applications of categories to be considered on priority:
a. Applications for registration of drugs or Local Manufacturing
Evaluator PEC-VI
883. Name and address of manufacturer / M/s Medisynth Pharmaceuticals, Islamabad

Applicant
Brand Name +Dosage Form + Strength Bre-Safe 2.5mg tablets

Letrozole……2.5mg
Pharmacological Group Non Steroidal aromatase inhibitor
Type of Form Form-5
Approval status of product in Reference FEMARA letrozole 2.5mg coated tablet by Novartis
Regulatory Authorities. Pharmaceuticals Australia Pty Ltd (TGA Approved)
Me-too status Femara 2.5mg Tablet by Novartis (Reg. No. 021129)
GMP status Last GMP inspection conducted on 19-09-2017, and the
report concludes that firm is operating at fair level of GMP
Decision: Registration Board approved registration of product in general manufacturing areas
with condition that manufacturer shall provide safety and protective measures for workers and
884. Name and address of manufacturer / M/s Aulton Pharmaceuticals, Hattar
Applicant
Brand Name +Dosage Form + Strength Letro 2.5mg tablets

Letrozole……2.5mg
Type of Form Form-5
GMP status Last inspection report 13-2-2018Firm is operating at good
level of compliance with GMP guidelines.
885. Name and address of manufacturer / M/s Werrick Pharmaceuticals, Islamabad
Applicant
Brand Name +Dosage Form + Strength Ven-Tab Tablets 10mg

Venetoclax……….10mg
Pharmacological Group Selective Inhibitor of BCL-2 Protein
Type of Form Form-5
Pack size & Demanded Price 10‘s, 20‘s, 30‘s, As per SRO
GMP status Last inspection report 7-12-2017 Firm was found to be
operating at a very good level of GMP compliance.
Remarks of the Evaluator. Me-too status could not be confirmed
Applicant

Type of Form Form-5
Applicant

Type of Form Form-5
Applicant
Brand Name +Dosage Form + Strength Weloda tablet 150mg

Capecitabine……….150mg
Pharmacological Group Fluropyrimidine Carbamate with Antineoplastic
Type of Form Form-5
Pack size & Demanded Price 20‘s, 30‘s,60‘s, As per SRO
Decision:
Deferred for evidence of applied formulation/drug already approved by DRAP (generic / me-too
status) alongwith registration number, brand name and name of firm and for deliberation upon
manufacturing requirements of anti-cancer/cytotoxic drugs
Applicant
Brand Name +Dosage Form + Strength Weloda tablet 500mg
Capecitabine ……….500mg
Pharmacological Group Fluropyrimidine Carbamate with Antineoplastic
Type of Form Form-5
Pack size & Demanded Price 20‘s, 30‘s,60‘s, As per SRO
Approval status of product in Reference Capecitabine Sandoz 500mg film coated tablet by Sandoz
Regulatory Authorities. Pty Ltd (TGA Approved)
Me-too status Xelocel 500mg Tablet by Hakimsons (Reg. No. 078107)
Decision:
Deferred for deliberation upon manufacturing requirements of anti-cancer/cytotoxic drugs
Applicant
Brand Name +Dosage Form + Strength Famclovir 500mg tablets

Famciclovir….500mg
Type of Form Form-5
Me-too status Miclovir Tablets 500mg Reg # 70361
report concludes that firm is operating at satisfactory level
of compliance of GMP.
Decision:
Applicant
Brand Name +Dosage Form + Strength Famclovir 250mg tablets

Famciclovir….250mg
Type of Form Form-5
Me-too status Famclor Tablets Reg # 068376
report concludes that firm is operating at satisfactory level
of compliance of GMP.
892. Name and address of manufacturer / M/s Scotmann Pharmaceuticals, Islamabad
Applicant
Brand Name +Dosage Form + Strength Anna Tablets 1mg
Anastrozole……1mg
Pharmacological Group Selective Aromatase Inhibitor
Type of Form Form-5
Pack size & Demanded Price 4x7‘s, 2x14‘s, As per SRO
Approval status of product in Reference ANASTROZOLE FBM anastrozole 1mg film coated tablet
Regulatory Authorities. by Southern Cross Pharma Pty Ltd (TGA Approved)
Me-too status Anastrozole 1mg Tablet by Novartis (Reg. No. 066179)
GMP status Last GMP panel Inspection conducted on 21.09.2017 with

grant of GMP.
893. Name and address of manufacturer / M/s Genome Pharmaceuticals, Hattar

Applicant
Brand Name +Dosage Form + Strength Everogen 5mg Dispersible tablets

Everolimus……5mg
Pharmacological Group Anti-neoplastic agent
Type of Form Form-5
Pack size & Demanded Price As per SRO, As per DPC
Approval status of product in Reference AFINITOR DISPERZ TABLET FOR ORAL
Regulatory Authorities. SUSPENSION. USFDA Approved
Me-too status Afinitor by Novartis Pharma 069519
GMP status Panel Inspection on 14-01-2017, No observations as

informed by QA.
Decision: Approved with Innovator’s Specification. Registration Board approved registration of
product in general manufacturing areas with condition that manufacturer shall provide safety and
protective measures for workers and personnel which remain in direct contact or are involved in
close handling of these drugs.

Applicant

Everolimus……3mg
Type of Form Form-5
informed by QA.

Applicant

Everolimus……2mg
Type of Form Form-5
informed by QA.
896. Name and address of manufacturer / M/s Jenner Pharmaceuticals, Sheikhupura

Applicant
Brand Name +Dosage Form + Strength Ovolet tablets 2.5mg

Letrozole…..2.5mg
Type of Form Form-5
GMP status Last GMP inspection of Jenner conducted on 06.11.2017
and the report concludes that overall the condition of firm
is satisfactory.
897. Name and address of manufacturer / M/s Neutro Pharma, Lahore
Applicant
Brand Name +Dosage Form + Strength Neutron 100mg tablets

Nitrofurantoin………….100mg
Type of Form Form-5
Pack size & Demanded Price 100‘s, As SRO
Me-too status Anatrin Tablet reg # 081913
GMP status Last inspection report 18-7-2017 Firm has maintained a fair
level of compliance with GMP.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Neustinb 12.5mg capsule

Sunitinib as Maleate………….12.5mg
Pharmacological Group Protein Kinase Inhibitor
Type of Form Form-5
Me-too status SUTENT 12.5MG CAPSULE Reg # 052225
Decision: Deferred for deliberation upon manufacturing requirements of anti-cancer/cytotoxic drugs.
Applicant
Brand Name +Dosage Form + Strength Neumethoxate 10mg tablet

Methotrexate………10mg
Pharmacological Group Cytostatic
Type of Form Form-5
Pack size & Demanded Price 1x10‘s, 5x10‘s, 10x10‘s, As SRO
Me-too status METHOTREXATE TABLET 10MG Reg# 066009
Decision: Deferred for deliberation upon manufacturing requirements of anti-cancer/cytotoxic
drugs
Applicant
Brand Name +Dosage Form + Strength Neuclud 0.05mg/ml Oral Solution
Composition Each ml oral solution contains:
Entecavir(as monohydrate)…..0.05mg
Type of Form Form-5
Pack size & Demanded Price 120ml, 210ml, As SRO
Approval status of product in Reference USFDA
Me-too status Cure-B oral 0.05mg Reg # 063499
GMP status Last inspection report 18-7-2017 Firm has maintained a
fair level of compliance with GMP.
Decision:
Applicant
Brand Name +Dosage Form + Strength Neuclud 0.5mg tablets
Entecavir(as monohydrate)…..0.5mg
Type of Form Form-5
Pack size & Demanded Price 30‘s, 90‘s, 1‘s, 10‘s, As per SRO
Approval status of product in Reference Baraclude tablets by Bristol Myers
Me-too status Livose-C tablets by Wilson
Decision:
Approved.

Applicant
Brand Name +Dosage Form + Strength Neutron 50mg tablets

Nitrofurantoin………….50mg
Type of Form Form-5
Applicant
Brand Name +Dosage Form + Strength Neuclud 1mg tablets

Entecavir(as monohydrate)…..1mg
Type of Form Form-5
Approval status of product in Reference Baraclude-MHRA
Me-too status Obee by Genome pharma
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Neumethoxate 2.5mg tablet
Methotrexate………2.5mg
Type of Form Form-5
Pack size & Demanded Price 30‘s, 10x10‘s, As SRO
Me-too status Methotrexate 2.5mg Reg #066008
drugs.

Applicant
Brand Name +Dosage Form + Strength Neucitabin 500mg tablet

Capecitabine………500mg
Type of Form Form-5
Pack size & Demanded Price 120‘ As SRO
Approval status of product in Reference Capecitabine Sandoz 500mg film coated tablet by Sandoz
Regulatory Authorities. Pty Ltd (TGA Approved)
Me-too status Xelocel 500mg Tablet by Hakimsons (Reg. No. 078107)
drugs
Applicant
Brand Name +Dosage Form + Strength Neuletroz 2.5mg tablet

Letrozole….2.5mg
Type of Form Form-5

Applicant
Brand Name +Dosage Form + Strength Neutacroli 1mg capsule
Tacrolimus as monohydrate….1mg
Type of Form Form-5
Approval status of product in Reference Prograf by Astellas
Me-too status Inograf by Platinum Reg # 045491
Applicant
Brand Name +Dosage Form + Strength Neuhydrox 500mg capsule

Hydroxyurea….500mg
Type of Form Form-5
Approval status of product in Reference HYDREA 500mg capsule by Bristol-Myers Squibb
Regulatory Authorities. Australia Pty Ltd(TGA Approved)
Me-too status Hydra 500mg Capsule by M/s Medinet (Reg. No. 028484)
drugs
Applicant
Brand Name +Dosage Form + Strength Neupencilin 250mg tablet
Penicillamine..…..250mg
Pharmacological Group Anti-rehumatic
Type of Form Form-5
Approval status of product in Reference Penicillamine 250 mg film-coated tablets by Generics
Regulatory Authorities. [UK] Limited (MHRA)
Me-too status Vistamin by Wilsons, Islamabad (R. No. 008202)

Decision: Approved.

Applicant
Brand Name +Dosage Form + Strength Neutrazol 1mg tablet

Anastrozole..…..1mg
Pharmacological Group Aromatase Inhibitor
Type of Form Form-5
Pack size & Demanded Price 28‘s, 30‘,10‘s, As per SRO
Decision:Registration Board approved registration of product in general manufacturing areas with
Applicant
Brand Name +Dosage Form + Strength Neuthoprin 50mg tablet

Azathioprine..…..50mg
Pharmacological Group Immunosupressant
Type of Form Form-5
Pack size & Demanded Price 10‘s,100‘s, As per SRO
Approval status of product in Reference Imuran tablets by Aspen
Me-too status Azoprine tablets by Global

Applicant
Brand Name +Dosage Form + Strength Neustinb 25mg capsule

Sunitinib as Maleate………….25mg
Pharmacological Group Protein Kinase Inhibitor
Type of Form Form-5
Me-too status SUTENT 25MG CAPSULE Reg # 052226
drugs.
913. Name and address of manufacturer / M/s Jaens Pharmaceutical, Sheikhpura
Applicant
Brand Name +Dosage Form + Strength Trozol 2.5mg tablets

Letrozole….2.5mg
Type of Form Form-5
GMP status Last inspection report 20-12-2017 Based on the area
inspected, the people met and considering the findings of
inspection, firm is operating satisfactory.
914. Name and address of manufacturer / M/s Kaizen Pharmaceuticals, Karachi
Applicant
Brand Name +Dosage Form + Strength Weletro tablet 2.5mg

Letrozole…..2.5mg
Type of Form Form-5
GMP status Last inspection report 18 july to 31 july 2017, the panel
recommends the renewal of DML
915. Name and address of manufacturer / M/s Navegal Laboratories, Hattar
Applicant
Brand Name +Dosage Form + Strength Navepro 500mg tablets
Deferiprone………500mg
Pharmacological Group Oral Iron Chealtor
Type of Form Form-5
Pack size & Demanded Price 1x10‘s, 3x10‘s, 5x10‘s, 10x10‘s, As per SRO
Me-too status Defcap Tablet Reg # 048031
GMP status Last inspection report 11-3-2017 The GMP was
satisfactory
Firm on priority.
916. Name and address of manufacturer / M/s Navegal Laboratories, Hattar
Applicant
Brand Name +Dosage Form + Strength Defrx 250mg tablet

Deferasirox……..250mg
Pharmacological Group Oral Iron Chelator
Type of Form Form-5
Me-too status Obsarox 250mg dispersible tablet Reg # 081465
satisfactory
Firm on priority.
917. Name and address of manufacturer / M/s Navegal Laboratories, hattar
Applicant
Brand Name +Dosage Form + Strength Defrx 500mg tablet

Deferasirox……..500mg
Pharmacological Group Oral Iron Chelator
Type of Form Form-5
Me-too status ODEROX -500 DISPERSIBLE TABLET Reg # 078116
satisfactory
Firm on priority.
918. Name and address of manufacturer / M/s Theramed Pharmaceutical, Lahore

Applicant
Brand Name +Dosage Form + Strength AC-Vir 400mg tablets

Acyclovir……400mg
Type of Form Form-5
Approval status of product in Reference Acyclovir by Teva Pharma
Me-too status Aclova by Akhai
GMP status Panel inspection report dated 10-10-2017 for Renewal of
DML and grant of additional sections
Decision:Approved
Applicant
Type of Form Form-5
Pack size & Demanded Price 10‘s, 20‘s, 25‘s,35, As per SRO
Me-too status Zoraxin 200mg Tablet
Decision:Approved
Applicant

Type of Form Form-5
Pack size & Demanded Price 10‘s, 20‘s, 25‘s,35, As per SRO
Me-too status Aclova 800mg Tablet Reg # 050788
Decision:Approved.
921. Name and address of manufacturer / Medizan Laboratories, Islamabad

Applicant
Brand Name +Dosage Form + Strength Anastrole 1mg tablet

Anastrozole…….1mg
Type of Form Form-5
Pack size & Demanded Price 10, 28‘s, As per SRO
GMP status Last inspection conducted on 10-4-2017 satisfactory compliance to
GMP
922. Name and address of manufacturer / M/s Fredmann Pharmaceuticals, Azad Kashmir
Applicant
Brand Name +Dosage Form + Strength Zoltrac 2.5mg tablet

Letrozole…….2.5mg
Type of Form Form-5
GMP status Last inspection report 24-11-2017 firm is operating at fair
level of cGMP as of today.
923. Name and address of manufacturer / M/s Pacific Pharmaceuticals, Lahore
Applicant
Brand Name +Dosage Form + Strength Morphine MR capsule 30mg
Composition Each extended release capsule contains:
Morphine sulphate…..30mg
Pharmacological Group Opoid
Type of Form Form-5
Pack size & Demanded Price 1x10‘s, 3x10‘s, As per the Brand leader
Approval status of product in Reference USFDA Approved Morphine Extended Release capsule
Regulatory Authorities. 30mg
Me-too status DURALGIN CAPSULES by AGP Reg # 021083
GMP status
Remarks of the Evaluator. Firm has provided a letter from licensing division dated 22-
2-2018,‖The board has approved the capsule
(Psychotropic/Narcotic) section.‖
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Morphate 10mg Prolong release tablet
Composition Each Prolong Release film coated tablet contains:

Morphine Sulfate Pentahydrate eq to
Morphine sulphate…….10mg
Type of Form Form-5
Approval status of product in Reference Filnarine SR 10 mg prolonged release film-coated tablets,
Regulatory Authorities. MHRA Approved
operating at a satisfactory level of compliance with GMP
Remarks of the Evaluator. Firm has tablet(psychotropic section)
Me-too status could not be confirmed.
Applicant
Brand Name +Dosage Form + Strength Morphate 30mg Prolong release tablet
Composition Each prolong release film coated tablet contains:

Morphine sulphate pentahydrate eq to Morphine
sulphate…..30mg
Type of Form Form-5
Approval status of product in Reference Filnarine SR 30 mg prolonged release film-coated tablets,
Regulatory Authorities. MHRA Approved
Remarks of the Evaluator. Firm has tablet(psychotropic section)
Me-too status could not be confirmed
Applicant
Brand Name +Dosage Form + Strength Morphate 15mg/ml Injection

sulphate…..15mg
Pharmacological Group Opiod
Type of Form Form-5
Pack size & Demanded Price 1ml, As per SRO
Approval status of product in Reference Morphine Sulfate 15mg/ml Solution for Injection, MHRA
Regulatory Authorities. Approved
Me-too status Qonza Injection Reg # 080060
Remarks of the Evaluator. Injectable(Psychotropic) section could not be confirmed.
formulation.
Applicant
Brand Name +Dosage Form + Strength Morphate 10mg/ml Injection

sulphate…..10mg
Pharmacological Group Opiod
Type of Form Form-5
Pack size & Demanded Price 1ml, As per SRO
Approval status of product in Reference Morphine Sulfate 15mg/ml Solution for Injection, MHRA
Regulatory Authorities. Approved
Me-too status Morfscot Injections 10mg Reg # 028300
Remarks of the Evaluator. Injectable (Psychotropic) section could not be confirmed.
formulation.
Applicant
Brand Name +Dosage Form + Strength Kill-B tablets 0.5mg

Entecavir as monohydrate…….0.5mg
Type of Form Form-5
Approval status of product in Reference Baraclude tablets by Bristol Myers
Me-too status Livose-C tablets by Wilson
GMP status The firm was granted GMP certificate based upon
Applicant
Brand Name +Dosage Form + Strength Tenofosave 300mg tablets

Tenofovir Disproxil Fumarate…….300mg
Type of Form Form-5
Finished product Specification IP
Approval status of product in Reference Tenofovir by Teva Pharma
Me-too status Tenofo-B by Getz
GMP status The firm was granted GMP certificate based upon
a. Export Facilitation
Evaluator PEC-VI
Export Facilitation: Application was received through letter No.F.7-7/2017-Reg-II, The firm claimed 4
molecules to be considered on priority‖. Out of which 3 molecules are presented here.
930. Name and address of manufacturer / M/s Searle Company Limited F-319 SITE, Karachi
Applicant
Brand Name +Dosage Form + Strength Jentin Met XR tablets
Composition Each Extended release film coated tablet contains:

Sitagliptin (as phosphate monohydrate)… …….50mg
Metformin HCl(as extended release)…..500mg
Approval status of product in Reference JANUMET XR USFDA Approved
Me-too status
GMP status Firm has cGMP certificate based on the evaluation
conducted on 12-6-2017
Stability studies and relevant documents are not
submitted
Decision: Deferred for submission of stability studies and relevant documents.
Applicant
Sitagliptin (as phosphate monohydrate)…….100mg
Me-too status
submitted
Applicant

Sitagliptin(as phosphate monohydrate) …….50mg
Me-too status
submitted
Applicant
Brand Name +Dosage Form + Strength Xyfort 200mcg/6mcg capsule

Budesonide…..200mcg
Formeterol Fumarate……6mcg
Pharmacological Group Long acting b-2 agonist
Type of Form Form-5
Finished product Specification Innovator‘s Specification
Pack size & Demanded Price As per DPC, As per DPC
Approval status of product in Reference Symbicort 200 Turbuhaler, by M/s AstraZeneca Health
Regulatory Authorities. Canada
Me-too status Zirwa by Getz
Applicant
Brand Name +Dosage Form + Strength Xyfort 100mcg/6mcg capsule

Budesonide…..100mcg
Formeterol Fumarate……6mcg
Pharmacological Group Long acting b-2 agonist
Type of Form Form-5
Finished product Specification Innovator‘s Specification
Approval status of product in Reference Symbicort 100 Turbuhaler, by M/s AstraZeneca Health
Regulatory Authorities. Canada
Me-too status Foracort by Highnoon
Applicant
Brand Name +Dosage Form + Strength Roxib 60mg tablets

Etoricoxib……60mg
Pharmacological Group Selective Cox-2 Inhibitor
Type of Form Form-5
Approval status of product in Reference Arcoxia 60mg tablet Of ( (MHRA Approved)
Me-too status Etroxin tablet 60mg Of M/S Akson Pharmaceuticals
Export Facilitation: Application was received through letter No.F.8-6/2013-Reg-V, The firm claimed 4
molecules to be considered on priority against USD616151.08 duly verified from submitted documents
(Foorm E, GD form and shipment invoices).
Out of 4 molecules, 1 molecule has been considered in previous DRB meeting in routine application
category. Remaining 3 molecules are presented here.
936. Name and address of manufacturer / M/s Searle Company Limited, 32km Multan road,
Applicant Lahore
Brand Name +Dosage Form + Strength Astroz 1mg tablet

Anastrozole…..1mg
Pharmacological Group Immunosupressant
Type of Form Form-5
Pack size & Demanded Price As per DPC
Approval status of product in Reference ANASTROZOLE FBM anastrozole 1mg film coated
Regulatory Authorities. tablet by Southern Cross Pharma Pty Ltd (TGA
Approved)
GMP status Last inspection report dated 8-2-2017: Panel confirms

Decision: Registration Board referred the case to QA & LT Division to conduct GMP inspection
of Firm on priority.
Applicant Lahore
Brand Name +Dosage Form + Strength Lexmara 2.5mg tablets

Letrazole…….2.5mg
Type of Form Form-5
Pack size & Demanded Price 2x10‘s, As per DPC
Approval status of product in Reference Femara by Novartis(MHRA Approved)
Me-too status Femara by Novartis

Decision: Registration Board referred the case to QA & LT Division to conduct GMP inspection
Applicant Lahore
Brand Name +Dosage Form + Strength Co-Extor tablets 10mg/320mg/25mg

Amlodipine as besilyate…….10mg
Valsartan…..320mg
Hydrochlorothiazide……25mg
Type of Form Form-5
Me-too status EXFORGE HCT 5mg/160mg/12.5mg of M/s Novartis,
Pakistan.
Decision:Registration Board referred the case to QA & LT Division to conduct GMP inspection
of Firm on priority
Applicant Lahore
Brand Name +Dosage Form + Strength Co-Extor tablets 10mg/160mg/25mg
Amlodipine as besilyate…….10mg
Valsartan…..160mg
Hydrochlorothiazide……25mg
Type of Form Form-5
Approval status of product in Reference Exforge HCT Of M/S Novartis (USFDA Approved)
Me-too status Exforge HCT of M/s Novartis Pharma (Pak) Ltd
Decision:Registration Board referred the case to QA & LT Division to conduct GMP inspection
Export Facilitation: Application was received through letter No.F.7-7/2017-Reg-II

940. Name and address of manufacturer / M/s Atco Laboratories, Karachi
Applicant
Brand Name +Dosage Form + Strength Synal Cream 0.025% w/w
Flucinolone Acetonide…0.25mg (0.025%)
Type of Form Form-5
Pack size & Demanded Price 5gm, 10gm, 15gm, 30gm
Approval status of product in Reference Synalar Cream MHRA Approved
Me-too status Flucin cream by Bio-labs Reg #048073
GMP status Panel inspection conducted on 21-07-2017 concludes
that firm is operating at the good GMP compliance.
Remarks of the Evaluator. Firm has Cream/Ointment/Gel, General, Steroidal
section according to panel inspection report.
Decision: Approved.
Export Facilitation: Application was received through letter No.F.8-6/2013-Reg-V. The firm has claimed 7
molecules against value of USD 704869 to be considered on priority.
941. Name and address of manufacturer / M/s Searle IV Solutions, Lahore
Applicant
Brand Name +Dosage Form + Strength Sarmic 1gm/10ml injection
Tranexamic acid……1gm
Pharmacological Group Fibrinolytic
Type of Form Form-5
Pack size & Demanded Price 10mlx10‘sampoule, Rs.980/pack
Approval status of product in Reference Cyklokapron 500mg Solution for Injection by M/s
Regulatory Authorities. Pfizer Limited (MHRA approved )
Me-too status Traxacid Injection 500mg/5ml by M/s Asian Continental
(Reg#057866)
GMP status Last inspection was conducted on 27-02-2018 firm was
found to be GMP compliant
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Pridoxmin tablets

Doxylamine succinate…..10mg
Pyridoxine HCl…..10mg
Type of Form Form-5
Pack size & Demanded Price 3x10‘s, Rs.130/pack
Me-too status Femiroz Tablet Reg # 061026
Remarks of the Evaluator. International availability could not be confirmed
Decision:Deferred for evidence of approval of applied formulation in reference regulatory
authorities/agencies which were declared/approved by the Registration Board in its 275 th
meeting.
Applicant
Brand Name +Dosage Form + Strength Omsenate Sachet

Omeprazole….40mg
Sodium Bicarbonate…..1680mg
Pharmacological Group Proton Pump Inhibitor/Antacid
Type of Form Form-5
Approval status of product in Reference Zegerid (USFDA Approved) Powder for oral suspension
Me-too status Risek Insta by Getz
Decision: Approved
944. Name and address of manufacturer / M/s Searle IV Infusions, Lahore
Applicant
Brand Name +Dosage Form + Strength Omsenate Sachet

Omeprazole….20mg
Sodium Bicarbonate…..1680mg
Pharmacological Group Proton Pump Inhibitor/Antacid
Type of Form Form-5
Approval status of product in Reference Zegerid (USFDA Approved) Powder for oral suspension
Me-too status Risek Insta by Getz
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength NalbuNil 10mg/ml Injection

Nalbuphine HCl……10mg
Pharmacological Group Narcotic
Type of Form Form-5
Pack size & Demanded Price 1mlx10‘s ampoule, Rs 566/pack
Approval status of product in Reference Nubain Injection 10mg/ml by M/s Sandoz Canada
Regulatory Authorities. Incorporated, Health Canada approved
Me-too status Kinz 10mg/ml Injection by M/s Sami


Applicant
Brand Name +Dosage Form + Strength Metrosit 50/500mg tablet
Sitagliptin(as phosphate monohydrate)….50mg
Metformin HCl….500mg
Pharmacological Group Biguanide/Dipeptidyl peptidase-47inhibitor
Type of Form Form-5
Pack size & Demanded Price 14‘s, Rs. 305/pack
Approval status of product in Reference Janumet film coated tablet 50/500mg of Merck Sharp &
Regulatory Authorities. Dohme (USFDA)
Me-too status Treviamet film coated tablet 50/500mg of M/s Getz
Pharmaceuticals
Applicant
Brand Name +Dosage Form + Strength Metrosit XR100/1000mg tablet

Sitgliptin(as phosphate monohydrate)….100mg
Type of Form Form-5
Approval status of product in Reference Janumet XR Extended release tablets
Me-too status
Remarks of the Evaluator. Firm has applied the formulation in film coated tablet.
Decision: Deferred for submission of stability studies and relevant documents as per 278 th
meeting.
Applicant
Brand Name +Dosage Form + Strength Metrosit 50/1000mg tablet

Sitgliptin(as phosphate monohydrate)….50mg
Type of Form Form-5
Approval status of product in Reference Janumet 50mg/1000mg Tablets by M/s Merck
Me-too status Duvel Plus 50mg/1000mg Tablet by M/s Martin Dow
pharmaceuticals
Applicant
Brand Name +Dosage Form + Strength Nezolid 600mg/300ml Infusion
Composition Each 300ml infusion contains:

Linezolid…..600mg
Pharmacological Group Oxazolidone
Type of Form Form-5
Pack size & Demanded Price 300ml, Rs.600/-
Me-too status Zolrest Infusion of M/s Bosch Pharmaceuticals
Decision:“In order to ensure, safety, efficacy and quality of Linezolid infusion, Registration
Board decided as under;
b. Finished Import (Human)

Evaluator PEC-V
950. Name and address of Applicant M/s Hoffmann Health Pakistan Ltd.
32-Babar Block, New garden town, Lahore.
Detail of Drug Sale License Address: 32-Babar Block, New garden town, Lahore.
Validity: 29, Nov, 2019
Status: License to sell drugs as a Distributor
Name and address of manufacturer M/s Panacea Biotec ltd., Village Malpur, Baaddi, District
Solan-173205, Himachal Pradesh, India
Name and address of marketing M/s Panacea Biotec ltd., Village Malpur, Baddi, District
authorization holder Solan-173205, Himachal Pradesh, India
Name of exporting country India
Brand Name +Dosage Form + Strength PanGraf 1mg Capsule
Tacrolimus….. 1mg
Finished Product Specification ---
Pharmacological Group Antineoplastic and Immunomodulating agents
Immunosuppressants (Calcineurin inhibitors)
ATC Code: L04AD02
Demanded Price Rs. 6,500/- per box of 50 capsules
Pack size 50‘s
International availability Prograf (0.5mg, 1mg, 5mg) hard capsules by M/s Astellas
Pharma Ltd, MHRA Approved.
Me-too status Inograf capsule 1mg by M/s Platinum Pharma (Reg 3 No.
045491)
Detail of certificates attached ● Original legalized CoPP
Certificate No. MB/05/203/WHO/GMP/15/115
Certifying Authority: State Drugs Controller,
Licensing Authority cum Controlling Authority,
Himachal Pradesh, India
Free sale: confirms the free sale of the product in
exporting country.
GMP: The facilities and operations conform to WHO-
GMP.
● The firm has claimed In House specifications while the
product is present in USP. The In House specifications
are more stringent than USP specifications.
● Moreover, the firm have claimed that there In-house
spec are stability indicating and validated.
● COPP was valid at the time of dossier submission.
Decision:
issued after the submission of valid original legalized CoPP since the provided Copp has been
expired.
951. Name and address of Applicant M/s Hoffmann Health Pakistan Ltd.
Name and address of manufacturer M/s Panacea BioTec ltd., Village Malpur, Baddi,
District Solan-173205, Himachal Pradesh, India
Name and address of marketing M/s Panacea BioTec ltd., Village Malpur, Baddi,
authorization holder District Solan-173205, Himachal Pradesh, India
Brand Name +Dosage Form + Strength PanGraf 0.5mg Capsule
Tacrolimus….. 0.5mg
Finished Product Specification --
Immunosuppressants ,Calcineurin inhibitors)
ATC Code: L04AD02
Demanded Price Rs. 4650/- per box of 50 capsules
Pack size 50‘s
International availability Prograf (0.5mg, 1mg, 5mg) hard capsules by M/s
Astellas Pharma Ltd, MHRA Approved.
Me-too status Inograf capsule 0.5mg by M/s Platinum Pharma (Reg #
045490)
Certificate No. MB/05/203/WHO/GMP/15/114
Licensing Authority cum Controlling Authority,
Himachal Pradesh, India
exporting country.
GMP.
● The firm has claimed In House specifications while
the product is present in USP. The In House
specifications for assay are more stringent than USP
specifications.
● The firm have claimed that there In-house spec are
stability indicating and validated.
Decision: Approved, as per Policy for inspection of Manufacturer abroad. Registration letter
will be issued after the submission of valid original legalized CoPP since the provided Copp has
been expired.
952. Name and address of Applicant M/s Hoffmann Helath Pakistan Ltd.
Name and address of manufacturer M/s Panacea biotec ltd., Village Malpur, Baaddi,
District Solan-173205, Himachal Pradesh, India
Name and address of marketing M/s Panacea biotec ltd., Village Malpur, Baddi, District
authorization holder Solan-173205, Himachal Pradesh, India
Brand Name +Dosage Form + Strength PanGraf 5mg Capsule
Tacrolimus….. 5mg
Finished Product Specification --
Immunosuppressants ,Calcineurin inhibitors)
ATC Code: L04AD02
Demanded Price Rs.16,500 /- per box of 30 capsules
Pack size 30‘s
International availability Prograf (0.5mg, 1mg, 5mg) hard capsules by M/s
Astellas Pharma Ltd, MHRA Approved.
Me-too status Inograf capsule 0.5mg by M/s Platinum Pharma (Reg #
045492)
CertificateNo. MB/05/203/WHO/GMP/15/116
Licensing Authority cum Controlling
Authority, Himachal Pradesh, India
exporting country.
GMP.
● The firm has claimed In House specifications while
the product is present in USP. The In House
specifications for assay are more stringent than USP
specifications.
● The firm has claimed that there In-house spec are
stability indicating and validated.
Decision:
issued after the submission of valid original legalized CoPP since the provided Copp has been
expired.
953. Name and address of Applicant M/s Novartis Pharma (Pakistan) Limited ,15 West Wharf , Karachi
Detail of Drug Sale License Address: 15 West Wharf , Karachi
Validity: 26 November 2019
Status: Drug license by way of whole sale
Name and address of Novartis Pharma Stein AG, pharmaceutical Operations Schweiz
manufacturer Solids Schaffhauserstrasse, 4332 Stein, Switzerland
Name and address of marketing Novartis Europharm Limited, Frimley Business Park, Camberley
authorization holder GU16 7SR, UK
Name of exporting country Switzerland
Diary No. & Date of R& I 23621, 11-12-17
Brand Name +Dosage Form + Tasigna Hard Capsule 50mg
Strength
Nilotinib as hydrochloride monohydrate….50mg
Pharmacological Group Antineoplastic
Protein kinase inhibitors ATC Code: L01XE08
Demanded Price 28 Capsules Rs. 152,000/-
112 Capsules Rs. 456,000/-
Pack size 28‘s ; 112‘s (PVC/PVDC Blister)
International availability Swissmedic
Me-too status ---
Detail of certificates attached ● Original CoPP
Certificate No: 02/18/115857
Certifying Authority: EMA
Issue Date: 8-1-2018
Free sale in exporting country: Yes
● GMP: The facilities and operations of manufacturing site
conform to GMP as recommended by WHO.
● Original & Legalized GMP Certificate
Certificate no. 16-1640
Manufacturer Address: Novartis Pharma Stein AG,
pharmaceutical Operations Schweiz Solids Schaffhauserstrasse,
4332 Stein, Switzerland
Certified by: Swiss Agency for Therapeutic Products
Inspection Date: 14-16 April 2017
Validity: Nil
● Agreement: dated 11th January 2018
Novartis Pharma AG, Lichtstrase 35, 4046 Basel, Switzerland
M/s Novartis Pharma (Pakistan) Limited ,15 West Wharf , Karachi
Decision: Approved as per Policy for inspection of Manufacturer abroad.
954. Name and address of M/s Pfizer Pakistan Limited,

Applicant 12, Dockyard Road, West Wharf Karachi.
Detail of Drug Sale License Address: Pfizer Paksitan limited (formerly Parke davis & Co. Ltd.)
B-2 S.I.T.E Karachi.
Status: drug license by the way of wholesale
Name and address of 1. M/s Hospira Australia Pty Ltd 1-5 7-23 and 25-39 Lexia Place
manufacturer Mulgrave VIC 3170 Australia
2. M/s Zydus Hospira Oncology Pvt Ltd
Plot No. 3 Pharmez-special Economic zone
NH No. 8A ,Sarkhej-Bavla Road,Village Matoda Tal Sanand
Ahmedabad Gujrat 382 213 India (responsible for Manufacture of
dosage form, packaging and labelling , Quality control)
Name and address of marketing M/s Hospira Australia Pty Ltd 1-5 7-23 and 25-39 Lexia Place
authorization holder Mulgrave VIC 3170 Australia.
Brand Name +Dosage Form + DBL GEMCITABINE Injection (IV) 1gm/26.3ml
Composition Each vial Contains:
Gemcitabine as hydrochloride……. 1gm
Pharmacological Group Antineoplastic And Immunomodulating Agents
Antimetabolites
Pyrimidine Analogues
ATC Code: L01BC05
Demanded Price Not provided
Pack size 1‘s
International availability Available in Australia as per CoPP
Me-too status Biogem (1000mg & 200mg) injection BY M/s UDL Pharma
(Imported) (Reg # 072581)
Detail of certificates attached ● Previous COPP( Original) provided by the firm
Certificate no. 17/0233
Certifying Authority: Certified by TGA, Australia on 17/03/2017
Free sale: Confirms the free sale of the applied product in
Australia.
GMP: The facilities and operations of manufacturing site in
Australia conform to GMP as recommended by WHO.
• New COPP (Original) provided by the firm.
Certificate No. MFG/WHO COPP/ZHOP/2018/007742
Certifying Authority: Food and Drug Control Administration ,
Gujrat, India
Exporter: India
Validity:03-08-2019
Free sale in exporting country: No
Reason: Not available in domestic market.
GMP: Facilities and operations conform to WHO-GMP.
● Letter of authorization/Sole agency agreement
It states that Pfizer Australia as product owner , hereby authorizes
Pfizer Pakistan Limited to submit an application to register the
above product which is manufactured at Zydus Hospira Oncology
Pvt. Ltd , Gujrat ,India
Remarks of the Evaluator. Reconstituted volume 26.3 ml
● The firm has claimed In House manufacturing specifications and
Deferred for the fol the product is present in USP.
● Variations in dossier have been observed. Product License
holder is in Australia, agreement is between Pfizer Australia
(Hospira) and Pfizer Pakistan while exporting country
mentioned on Form-5A is India.
● Firm has submitted two COPP‘s:
o Australia
o India
Decision: Registration Board was apprised of the fact that;
● Sole Agency agreement submitted by firm is between M/s Pfizer Australia (as product
owner) and M/s Pfizer Pakistan wherein M/s Pfizer Pakistan has been authorised to
submit an application to register the above product which is manufactured at M/s
Zydus Hospira Oncology Pvt. Ltd, Gujarat, India.
● The applicant has submitted CoPP issued by TGA Australia, wherein status of M/s
Pfizer Australia is “a” as per para 2.3 which explains as “manufacturer of the dosage
form.”
● CoPP does not support the Indian site i.e. M/s Zydus Hospira Oncology Pvt. Ltd,
Gujarat, India, as manufacturer of the dosage form.
● DSL of the applicant is invalid.
Registration Board after due deliberation deferred the case for clarification of above cited
observations.
955. Name and address of M/s Pfizer Pakistan Limited,

Applicant 12, Dockyard Road, West Wharf Karachi.
Detail of Drug Sale License Address: Pfizer Paksitan limited (formerly Parke davis & Co. Ltd.)
B-2 S.I.T.E Karachi.
Status: drug license by the way of wholesale
Name and address of 1. M/s Hospira Australia Pty Ltd 1-5 7-23 and 25-39 Lexia Place
manufacturer Mulgrave VIC 3170 Australia
2. M/s Zydus Hospira Oncology Pvt Ltd
Plot No. 3 Pharmez-special Economic zone
NH No. 8A ,Sarkhej-Bavla Road,Village Matoda Tal Sanand
Ahmedabad Gujrat 382 213 India (responsible for Manufacture of
dosage form, packaging and labelling , Quality control)
Name and address of marketing M/s Hospira Australia Pty Ltd 1-5 7-23 and 25-39 Lexia Place
authorization holder Mulgrave VIC 3170 Australia.
Diary No. & Date of R& I Dy. No. NIL
Brand Name +Dosage Form + DBL GEMCITABINE Injection (IV) 200mg/5.3ml
Composition Each vial Contains:
Gemcitabine as hydrochloride……. 200mg
Pharmacological Group Antineoplastic And Immunomodulating Agents
Antimetabolites
Pyrimidine Analogues
ATC Code: L01BC05
Demanded Price Not provided
Pack size 1‘s (5.3ml vial)
International availability Available in Australia as per CoPP
Me-too status Biogem (1000mg & 200mg) injection BY M/s UDL Pharma
(Imported) (Reg # 072580)
Detail of certificates attached ● Previous COPP( Original) provided by the firm
Certificate no. 17/0237
Certifying Authority: Certified by TGA, Australia on 17/03/2017
Free sale: Confirms the free sale of the applied product in
Australia.
GMP: The facilities and operations of manufacturing site in
Australia conform to GMP as recommended by WHO.
● New COPP (Original) provided by the firm.
Certificate No. MFG/WHO COPP/ZHOP/2018/007741
Certifying Authority: Food and Drug Control Administration ,
Gujrat, India
Exporter: India
Validity:03-08-2019
Free sale in exporting country: No
Reason: Not available in domestic market.
GMP: Facilities and operations conform to WHO-GMP.
● Letter of authorization/Sole agency agreement
It states that Pfizer Australia as product owner , hereby authorizes
Pfizer Pakistan Limited to submit an application to register the
above product which is manufactured at Zydus Hospira Oncology
Pvt. Ltd , Gujrat ,India
Remarks of the Evaluator Reconstituted volume 5.26 ml
● The firm has claimed In House manufacturing
specifications and the product is present in USP.
● Variations in dossier have been observed. Product License
holder is in Australia, agreement is between Pfizer
Australia (Hospira) and Pfizer Pakistan while exporting
country mentioned on Form-5A is India.
● Firm has submitted two COPP‘s:
● Australia
● India
Decision:
Registration Board was apprised of the fact that;
● Sole Agency agreement submitted by firm is between M/s Pfizer Australia (as product
owner) and M/s Pfizer Pakistan wherein M/s Pfizer Pakistan has been authorised to
submit an application to register the above product which is manufactured at M/s
Zydus Hospira Oncology Pvt. Ltd, Gujarat, India.
● The applicant has submitted CoPP issued by TGA Australia, wherein status of M/s
Pfizer Australia is “a” as per para 2.3 which explains as “manufacturer of the dosage
form.”
● CoPP does not support the indian site i.e. M/s Zydus Hospira Oncology Pvt. Ltd,
Gujarat, India, as manufacturer of the dosage form.
● DSL of the applicant is invalid.
Registration Board after due deliberation deferred the case for clarification of above cited
observations.
c. Finished Import (Veterinary)
Evaluator-PEC-V
956. Name and address of M/s Vetline International

Applicant 55/5, First Floor, Main Shadman Market, Lahore
Detail of Drug Sale License Address: M/s Vetline International
55/S, First Floor, Main Shadman Market, Lahore
Name and address of M/s Range Pharma Sdn. Bhd
manufacturer No. 1, Jalan TSB 11
Taman Industri Sungai Buloh
47000 Sungai Buloh
Selongor Darul Ehsan
Malaysia
Name and address of marketing M/s Range Pharma Sdn. Bhd
authorization holder No. 1, Jalan TSB 11
47000 Sungai Buloh
Malaysia
Name of exporting country Malaysia
Brand Name +Dosage Form + CEFALEXOL Powder 50%
Strength
Cefalexin as monohydrate…500g
Finished Product Specification Inhouse
Pharmacological Group Antibacterial for systemic use
Shelf life 3 years. After Dilution 24 hrs.
Pack size 100g ,500g and 1 kg pouches
International availability Not confirmed
Me-too status N/A
Detail of certificates attached Original Legalized Certificate
Certificate No. 0001H/2018
Certifying Authority: Drug Control Authority
NPRA (National Pharmaceutical Regulatory Agency)
Free Sale: Confirms the free sale of the product in exporting
country.
GMP: The facilities and operations conform to GMP as
recommended by WHO.
Issue date: 10th Jan 2018
Validity: 24 Months
Original Legalized Free Sale Certificate
Certificate No. CFS-030H/2017
Certifying Authority:
Issue date: 31st May 2017
Validity: 24 Months
GMP Certificate
Certificate No. 061/17
Certifying Authority: NPRA (National Pharmaceutical Regulatory
Agency)
Validity: 10-Nov-2018
Agreement
M/s Range Pharma Sdn. Bhd
No. 1, Jalan TSB 11
47000 Sungai Buloh
Malaysia &
M/s Vetline International
55/5, First Floor, Main Shadman Market
Lahore
Date:15 May, 2017
Validity : 3 years
Remarks of the Evaluator. Target Specie: Poultry
Withdrawal Period: 7 days
International Availability could not be confirmed.
Decision:
Deferred for confirmation of Me-too/approval status in reference regulatory authorities.
Case No 11 Miscellaneous cases

Evaluator-II
Following cases were discussed in 273rd meeting of Registration Board details of which are as under:
957. Name and address of manufacturer / M/s Hilton Pharma (Pvt.) Ltd., Karachi.
Applicant
Brand Name +Dosage Form + Sitaglu Met XR 50/500 mg tablet
Strength
Diary No. Date of R& I & fee Dy. No. 1206 (06-07-2012)
Rs: 15,000 (06-07-2012), Rs: 35,000 (24-06-2014)
Sitagliptin phosphate monohydrate eq. to Sitagliptin….50 mg
Metformin hydrochloride (extended release)….500 mg
Finished Product Specification Manufacturer‘s specifications.
Pack size & Demanded Price 10‘s, 14‘s, 20‘s, 28‘s

As per DPC
Approval status of product in Janumet XR –USFDA approved
Me-too status Not applicable
GMP status Last GMP Inspection of conducted on 17-10-2016 with
conclusive remarks of cGMP compliant.
Remarks of the Evaluator. ● Master formulation submitted does not state
quantities of excipients.
● Manufacturing method is general outline and does
not describe stepwise process of manufacturing
for applied formulation.
● Firm has claimed manufacturer‘s specifications.
● Dissolution parameters stated in finished product
testing method is not as per USFDA
recommendations.
Drug Sitaglu Met XR 50/500 mg tablet

Name of Manufacturer M/s Hilton Pharma (Pvt.) Ltd., Karachi.
Sitagliptin phosphate monohydrate: M/s Ruyuan HEC Pharm Co.,
Ltd., China
Manufacturer of API
Metformin hydrochloride: M/s Abhilash Chemicals &
Pharmaceuticals Pvt. Ltd., India
Sitagliptin phosphate monohydrate: STP-RD201603101B
API Lot No.
Metformoin hydrochloride: MET/01/15050727
Description of Pack
Alu-Alu foil in printed unit carton
Accelerated: 40°C ± 2°C & 75%±5%RH
Stability Storage Condition
Real Time: 30°C ± 2°C & 65%±5%RH
Time Period
Real Time: 6 Months
Accelerated: 0,3,6 (months)
Frequency
Real Time: 0,3,6 (months)
Batch No. SIM-232601-1 SIM-230012-2 SIM-230012-3
No. of Batches 03
Sr.
Documents To Be Provided Status
No.
1. COA of API Yes
Copy of GMP certificate issued by
Shaoguan food and Drug Administration
has been submitted for M/s Ruyuan HEC
Pharm Co., Ltd. The certificate is valid
upto 14-12-2017
Approval of API by regulatory authority of country
2. of origin or GMP certificate of API manufacturer
Department of Food safety and Drugs
issued by regulatory authority of country of origin.
Control administration, Govt. of Tamil
Nadu has been submitted for M/s
Abhilash chemicals & pharmaceuticals
Pvt. Ltd. The certificate is valid upto 31-
12-2018
Protocols followed for conduction of stability study
3. Yes
Data of 03 batches will be supported by attested
4. respective documents like chromatograms, Yes
Copy of ADC (Karachi) attested invoice
provided.
All provided documents will be attested (name,
6. sign and stamp) for ensuring authenticity of data / Yes
documents.
Commitment to continue real time stability study
7. Yes
till assigned shelf life of the product.
Commitment to follow Drug Specification Rules,
8. Yes
1978.
(AD PEC-II)
i. Finished product specifications state description as Oblong biconvex coated bilayer tablet, where as
ii. Firm has submitted revised Form 5-D.
iii. Firm has submitted revised manufacturing method.
iv. Revised manufacturing method submitted for Sitaglu Met range tablets state the manufacturing of
bilayer compressed tablets where Sitagliptin core and Metformin hydrochloride core are compressed
together to form bilayer tablet. The stated method is not as per reference product where a matrix
release tablet core of Metformin hydrochloride is covered with Sitagliptin active coating to provide
immediate release of Sitagliptin.
v. Firm has submitted revised finished product testing method along with stability studies data.
vi. Dissolution parameters stated in finished product testing method, submitted along with stability
studies data are not as per recommended by USFDA.
Decision: Registration Board deliberated the case and decided to call firm‘s representative in next Board
meeting for clarification/justification of following points:
i. In contrary to approved by the reference agencies/authorities wherein the innovator‘s product
contains a matrix release tablet core of Metformin hydrochloride is covered with Sitagliptin active
coating to provide immediate release of Sitagliptin, while firm has manufactured bilayer compressed
tablets where Sitagliptin core and Metformin hydrochloride core are compressed together to form
bilayer tablet.
ii. Dissolution parameters stated in finished product testing method, submitted along with stability
958. Name and address of manufacturer / M/s Hilton Pharma (Pvt.) Ltd., Karachi.
Applicant
Strength
Rs: 15,000 (06-07-2012), Rs: 35,000 (24-06-2014)
Sitagliptin phosphate monohydrate eq. to Sitagliptin….100
mg

As per DPC
● Manufacturing method is general outline and does
not describe stepwise process of manufacturing
for applied formulation.
recommendations.

Sitagliptin phosphate monohydrate: M/s Ruyuan HEC Pharm Co., Ltd.,
China
Manufacturer of API
Metformin hydrochloride: M/s Abhilash Chemicals & Pharmaceuticals
Pvt. Ltd., India
API Lot No.
Description of Pack
(Container closure Alu-Alu foil in printed unit carton
system)
Stability Storage Accelerated: 40°C ± 2°C & 75%±5%RH
Condition Real Time: 30°C ± 2°C & 65%±5%RH
Time Period
Real Time: 6 Months
Frequency
No. of Batches 03
Sr.
No.
1. COA of API Yes
Copy of GMP certificate issued by Shaoguan
food and Drug Administration has been
submitted for M/s Ruyuan HEC Pharm Co.,
Approval of API by regulatory authority of Ltd. The certificate is valid upto 14-12-2017
country of origin or GMP certificate of API Copy of GMP certificate issued by
2.
manufacturer issued by regulatory authority Department of Food safety and Drugs Control
of country of origin. administration, Govt. of Tamil Nadu has been
submitted for M/s Abhilash chemicals &
pharmaceuticals Pvt. Ltd. The certificate is
Protocols followed for conduction of
3. Yes
Data of 03 batches will be supported by
4. Yes
sheets etc.
Copy of ADC (Karachi) attested invoice
provided.
All provided documents will be attested
6. (name, sign and stamp) for ensuring Yes
Commitment to continue real time stability
7. Yes
Commitment to follow Drug Specification
8. Yes
Rules, 1978.
(AD PEC-II)
Decision:
Registration Board deliberated the case and decided to call firm‘s representative in next Board meeting for
clarification/justification of following points:
bilayer tablet.
studies data are not as per recommended by USFDA
959. Name and address of manufacturer M/s Hilton Pharma (Pvt.) Ltd., Karachi.
/ Applicant
Strength
Rs: 15,000 (06-07-2012), Rs: 35,000 (24-06-2014)
Sitagliptin phosphate monohydrate eq. to Sitagliptin….50 mg

As per DPC
● Manufacturing method is general outline and
does not describe stepwise process of
manufacturing for applied formulation.
recommendations.

Sitagliptin phosphate monohydrate: M/s Ruyuan HEC Pharm Co.,
Ltd., China
Manufacturer of API
Metformin hydrochloride: M/s Abhilash Chemicals &
Pharmaceuticals Pvt. Ltd., India
API Lot No.
Description of Pack
Alu-Alu foil in printed unit carton
Stability Storage Accelerated: 40°C ± 2°C & 75%±5%RH
Condition Real Time: 30°C ± 2°C & 65%±5%RH
Time Period
Real Time: 6 Months
Frequency
No. of Batches 03
Sr.
No.
1. COA of API Yes
Shaoguan food and Drug
Administration has been submitted for
M/s Ruyuan HEC Pharm Co., Ltd. The
certificate is valid upto 14-12-2017
Approval of API by regulatory authority of country
2. of origin or GMP certificate of API manufacturer
Department of Food safety and Drugs
issued by regulatory authority of country of origin.
Control administration, Govt. of Tamil
Nadu has been submitted for M/s
Abhilash chemicals & pharmaceuticals
Pvt. Ltd. The certificate is valid upto
31-12-2018
Protocols followed for conduction of stability study
3. Yes
Data of 03 batches will be supported by attested
4. respective documents like chromatograms, Yes
Copy of ADC (Karachi) attested
invoice provided.
All provided documents will be attested (name, sign
6. and stamp) for ensuring authenticity of data / Yes
documents.
Commitment to continue real time stability study
7. Yes
Commitment to follow Drug Specification Rules,
8. Yes
1978.
(AD PEC-II)
Decision:
Registration Board deliberated the case and decided to call firm‘s representative in next Board meeting for
clarification/justification of following points:
bilayer tablet.
In this regard literature of reference product Janumet XR (approved by USFDA) is presented below for
deliberation of Board.
Reference USFDA
Decision of 273rd meeting: Mr. Tahir Nabi Mirza, Director Technical appeared before the
Board, for clarification regarding variation in manufacturing technology and
dissolution conditions from that of reference innovator product i.e. Janumet XR
(USFDA approved). The representative emphasized the bilayered manufacturing
technology used by firm gave a comparable dissolution profile to as that of reference
innovator product. He also stated that a comparative dissolution study has been
performed which concluded comparable results of applied and reference product and
can be confirmed by onsite inspection.
Registration Board deferred the case for further deliberation.
● Now the Firm has submitted Comparative dissolution study protocol & results. The details of
reference product & Sample product are as follows:
Feature Reference product Product of Hilton

Brand name JanuMet XR 100-
1000mg tablet SitagluMet XR 100-
1000mg tablet
Sitagliptin (pH 1.2) 67
Metformin (pH 1.2) 88
Metformin (pH 4.5) 89
Similarity factor Metformin (pH 6.8) 75
Decision of 278th meeting: Registration Board advised the PEC to evaluate the case in light
of guidelines and reference literature shared by firm during, and place the case in agenda of
next Board meeting for further deliberation.
Fresh Evaluation:
● Firm has referred to following literature of ―WHO Technical Series No. 970, 2012‖ on ―WHO
Expert Committee on Specifications for Pharmaceutical Preparations‖
a. Manufacturing process development
“The manufacturing process of the multisource FPP should be appropriate for the product that is
in development. It does not need to be the same as that of the comparator FPP.
Efforts should be primarily directed towards reducing variability in process and product quality.
In order to achieve this, all critical sources of variability should be identified and explained and
the sources of variability should be minimized and controlled.
Differences between the manufacturing process (es) used to produce comparative bioavailability
or biowaiver batches and the process described in 3.2.P.3.3 that can influence the performance of
the product should be discussed.‖
● Firm has referred to the following term of ―Process Robustness‖ as described in the ICH
Guideline for ―Pharmaceutical Development Q8 (R2)‖
Process Robustness:
―Ability of a process to tolerate variability of materials and changes of the process and equipment
without negative impact on quality.‖
● Firm has also referred to USFDA‘s Definition of generic product as under:
―A generic drug is identical, or bioequivalent to a brand name drug in dosage form, safety, strength
route of administration, quality performance characteristics and intended use.‖
Decision: Deferred for further deliberation regarding the impact of change in

manufacturing method upon the specifications of applied formulation with
reference to Innovator's product.
Evaluator-PEC-VI
2. Correction in the composition of the product.
The board has approved the following product in 278th meeting. Due to typographical
mistake, the strength was changed from 0.25mg to 2.5mg. The firm has applied for the 0.25mg
strength of everolimus. The correct product is hereby presented before the board.
Incorrect Strength
960. Name and address of manufacturer / M/s Kaizen Pharmaceuticals, Karachi
Applicant
Brand Name +Dosage Form + Strength Grafles 2.5mg tablets

Everolimus……2.5mg
Type of Form Form-5
Me-too status Afinitos 2.5mg tablet Reg # 78105
GMP status Last inspection report 18 & 31 July 2017 recommended
renewal of DML
Decision of 278th meeting:
Registration Board approved registration of product in general manufacturing areas with condition that
manufacturer shall provide safety and protective measures for workers and personnel which remain in
direct contact or are involved in close handling of these drugs.
Correct Strength
Name and address of manufacturer / M/s Kaizen Pharmaceuticals, Karachi
Applicant
Brand Name +Dosage Form + Strength Grafles 0.25mg tablets

Everolimus……0.25mg
Type of Form Form-5
Me-too status Certican tablets 0.25mg Reg # 044829
GMP status Last inspection report 18 & 31 July 2017 recommended
renewal of DML
Decision: Registration Board revised the decion of 278th meeting and approved the applied
formulation as following details:
“Grafles 0.25mg tablets
Everolimus……0.25mg”
Registration-I Section
Case No. 1 Request of M/s. Sanofi-aventis Pakistan Limited, Karachi for exemption
from labeling text on low volume Oncology and Specialty care products.
M/s. Sanofi-aventis Pakistan Limited, Karachi has informed that their following
registered products are being manufactured in large volume at the source point from which
supplies are made to various countries according to their needs and because of limited
requirements of these products in Pakistan it is not feasible to incorporate some of the
requirements of labeling Rules at the source point.
S.# Regn. Name of Product/ Composition Source

No.
1. 044890 Eloxatin 50mg/10ml concentrate for M/s. Sanofi-aventis Deutschland
Solution for infusion. GmbH, Bruningstrasse 50, D-65926
Each ml contains: Frankfurt am Main, Germany
Oxaliplatin…5mg
2. 044891 Eloxatin 50mg/10ml concentrate for -do-
Solution for infusion.
Each ml contains:
Oxaliplatin…5mg
3. 078125 Jevtana Concentrate for Infusion. -do-
Each 1.5ml vial concentrate
cpntains:
Cabazitaxel acetone solvent 60mg
4. 066089 Taxotere 20mg/ml concentrate for -do-
solution for infusion.
Each vial contains:-
Docetaxel…20mg
5. 066090 Taxotere 80mg/4ml concentrate for -do-
solution for infusion.
Each vial contains:-
Docetaxel…80mg
Therefore, the firm has requested to grant them permission for import of the above
mentioned products in Standard Export Packs and subsequent local reprinting of Registration
Number, MRP and Urdu Text (Brand Name) at the licensed premises located at Plot 23, Sector
22, Korangi Industrial area, Karachi having DML No. 000007.
Further, the firm has provided local SOP for “Control of Repacking Operations” and
sales record on years 2015, 2016 and 2017. Details are as under:
S Product Name No of units import No of units sold Sales record (units)
# 2015 2016 2017 2015 2016 2017 MAT MAT MAT
Q32015 Q32016 Q32017
1 Eloxatin 50mg 2408 3441 1960 3639 3569 2150 6217 7215 4856
2 Eloxatin 100mg 3398 3366 1680 4139 3725 2418
3 Jevtana 60mg - 152 - 71 63 35 32 51 32
4 Taxotere 20mg 28799 10006 14043 31076 15734 13136 36025 21548 15023
5 Taxotere 80mg 9180 2993 1284 6294 6342 1480
Decision:- Registration Board deferred the case for further clarification from the firm
regarding the status of labeling requirements in previous imports.
Case No. 2 Request of M/s. Medipharm (Pvt) Limited, Lahore for correction in
Primary packaging from “ampoule” to “vial” and import permission for
registered product Magnevist (Reg.No.011539).
M/s. Medipharm (Pvt) Limited, Lahore has requested for correction in primary
packaging from ―ampoule‖ to ―vial‖ for their registered product Magnevist injection
(Reg.No.011539) as per following details.
Primary Packaging Container Correction required as
Mentioned on letters
Magnevist Injection 10ml ampoule and Magnevist Injection 10ml vial and
20ml ampoule 20ml vial
The firm has informed that the product was registered in favor of M/s. Ali Gohar & Co,
Karachi dated 07-02-1991 and additional pack size for the same product was granted in May,
2002. The firm further informed that in registration letter and approval letter for additional pack
size the container closure was mentioned as ampoule. However, the said product is available in
vial form and the firm has always imported the vials.
In support of the above correction, firm has provided a copy of product monograph issued
by Health Canada wherein it has been mentioned that Magnevist is supplied in 20ml, 15ml and
10ml single dose vials packaged in individual cartons. It is pertinent to mention that the case has
been discussed in 6th PRVC meeting and Committee decided to place the case before Registration
Board.
Furthermore, the firm also requested for ―Import Permission‖. The firm informed that they
have received a final decision by the European Commission (EC) dated November 23, 2017
adopting the EMA Committee for Medicinal Products for Human Use (CHMP) opinion to
suspend the marketing authorization for all linear gadolinium based contrast agents (GBCA‘s) due
to negative risk-benefit profile, including Bayer‘s product Magenvist. The EC decision is
addressed to the EU member states and is binding on them with the effect that each national
competent regulatory authority has to implement the EC decision on national level and to suspend
the national marketing authorization for Magnevist.
For Germany, the competent German regulatory authority issued a national suspension
decision concerning the marketing authorization for Magnevist which became effective on
February 28, 2018 at which Bayer is prohibited from exporting Magnevist from German
manufacturing site unless an informed consent (declaration) for the import of Magnevist by the
competent health authority from country of destination has been obtained.
The firm requested, in order to ensure continued delivery to meet patient‘s need in
Pakistan, to grant them Import Permission for continued import of Magnevist into Pakistan.
The firm also informed that US-FDA has allowed continued import of Magnevist to US.
Copy of import permission is provided by the firm.
Decision:- Registration Board deliberated the matter in detail and decided as follow;
a. The firm M/s. Medipharm (Pvt) Ltd, Karachi shall be called for
personnel hearing for clarification regarding the matter of primary
container closure.
b. Regarding the determination of risk-benefit profile of “linear
gadolinium based contrast agents” the case shall be referred to the
heads of Radiology Department of following institutions for their
opinion keeping in view risk-benefit ratio;
i. Pakistan Institute of Medical Sciences (PIMS), Islamabad
ii. Combine Military Hospital (CMH), Rawalpindi
iii. Shifa International Hospital, Islamabad
c. List of registered alternate molecules with DRAP used as contrast
agents to be provided.
Case.No.3 Request of M/s. Wyeth Pakistan Limited for Change of Local Address.
M/s. Wyeth Pakistan Limited, Room No. 002 & 003, PGS Admin Block, First Floor, Plot
No. B-2, S.I.T.E, Karachi has requested for change of address for their following registered
products from the one mentioned on DML (i.e 000006) to the address mention on DSL, as the
manufacturing premises has been sold to M/s. ICI Pakistan Limited.
S.No Product Name & Reg.No Current Name & Proposed Name &
Composition Address of importer (as Address of Importer (as
per initial reg.letter) per DSL)
1. Rapamune Solution 027339 M/s. Wyeth Pakistan M/s. Wyeth Pakistan
Each ml contains: Limited, S-33, Hawkes Limited, Room No. 002 &
Sirolimus…1mg Bay Road, S.I.T.E, 003, PGS Admin Block,
Karachi. First Floor, Plot No. B-2,
S.I.T.E, Karachi.
2. Rapamune Tablet 031376 -do- -do-
Sirolimus…1mg
Firm has deposited Rs. 5000/- for each product and provided the following documents:
a. Copy of initial registration letters and last renewal status.
b. Attested copy of change of address by SECP.
c. Receipt of application of drug sale license.
d. Mock up art works with proposed new address of importer.
e. Undertaking.
Decision: Registration Board deferred the case for provision of valid Drug Sale License
(DSL), as the firm has only provided receipt of application submitted for
grant of DSL, for further consideration of the matter.
Case.No.4 Request of M/s. Eli Lilly Pakistan (Private) Limited, Karachi for
change of manufacturer for registered product.
M/s. Eli Lilly Pakistan (Private) Limited, Karachi has applied for change of manufacturer
of their following already registered imported veterinary product as per details given below:-
S. Reg. Name of Current Approved New Proposed site

No. No. Products/Approved site
Packing & Shelf life
1. 083242 Clinacox 0.5% Oral M/s. BIOVET Manufacturing site:
Premix Joint Stock M/s. Laboratoria Smeets NV,
Company 39,
Each gram contains:- Neerlandweg 24 &
Petar Rakov Fotografielaan 42-46, 2610
Diclazuril….5mg Street, Peshtera Wilrijk-Belgium.
(as per innovator‘s 4550, Bulgaria.
specification) Market authorization holder:
M/s. Eli Lilly and Company
Elanco Animal Health, Lilly
20 Kg
House, Priestley Road,
03 Years Basingstoke, Hampshire RG24
9NL-United Kingdom.
The firm have deposited fee of Rs.100,000/- and submitted following supporting
documents:-
i) Application on Form 5A.
ii) Copy of initial registration letter.
iii) Original & legalized GMP certificate issued by competent authority of Belgium.
iv). Attested registration certificate of the said product issued by competent authority
of Belgium.
v). Site master file.
The firm has provided attested registration certificate of the said product issued by
competent authority of Belgium instead of free sales certificate, with the explanation letter from
the market authorization holder i.e M/s. Elanco Animal Health wherein it has been informed that
for feed additives FSC/CPP certificates are not applicable.
Decision:- Registration Board approved the following changes in respect of registered drug
Clinacox 0.5% Oral Premix (Reg.No. 083242) on the same terms & conditions and as
per import Policy for Finished Drugs.
a) Change of manufacturing site from M/s. BIOVET Joint Stock Company 39,
Petar Rakov Street, Peshtera 4550, Bulgaria to M/s. Laboratoria Smeets NV,
Neerlandweg 24 & Fotografielaan 42-46, 2610 Wilrijk-Belgium.
b) Market authorization holder: M/s. Eli Lilly and Company Elanco Animal
Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL-
United Kingdom.
VETERINARY
Case No.5 Request of M/s. Zoic International, Lahore for transfer of Registration of
Veterinary Drugs from Import to Local Manufacturing.
Registration Board in its 263rd meeting, while considering a complaint regarding M/s. Zoic
International, Lahore for allegedly obtaining registration of various imported products on fake
documents, after personal hearing, advised the firm to make formal applications for change in
status of registered products from import to local manufacture of the products in question after
completing all the requirements including NOC from the manufacturer/products licensed holder
for its consideration.
M/s. Zoic International, Lahore subsequently requested for transfer of registration of

following registered imported veterinary drugs from import from M/s. Tithebarn Ltd UK to local
manufacturing at their plant M/s. Zoic International, Lahore, Plot # 573, Sunder Industrial Estate,
Multan Road, Lahore as per detail mentioned against each:-
S. Reg. Name of Drug (s)/ Composition Name of Drug (s)/ Packing Packin
No No. As per registration letter. Composition Size as per g Size
. As per Dossier. registratio as per
n letter dossier
1. 02129 Cocostop 20% Water Soluble Cocostop 20% Water Soluble 100gm 25gm
7 Powder Powder 200gm 50gm
Each gm contains:- Each gm Water Soluble Powder 500gm 100gm
Amprolium contains:- 1 Kg 500gm
HCL…………..200mg Amprolium 1 Kg
Hdrochloride..200mg 5 Kg
Sachet/
Jar
2. 02129 Quincure 20% Liquid Water Quincure 20% Liquid 100ml 25ml
8 Soluble Solution Each 100ml oral liquid 250ml 50ml
Each ml contains:- contains:- 500ml 100ml
Flumequine………………..200mg Flumequin BP…………20g 1 Litre 250ml
500ml
1000ml
Bottle/
Can
3. 02129 Quintril 20% Liquid Water Soluble Quintril 20% Liquid 100ml 25ml
9 Solution Each 100ml contains:- 250ml 50ml
Each ml contains:- Norfloxacin…………..20g 500ml 100ml
Norfloxacin…………………200m 1 Litre 250ml
g 500ml1
Litre 5
Litre
HDPP
Plastic
Bottles.
4. 04958 Tithedox Water Soluble Powder Tithedox Water Soluble Powder 150gm 25gm
0 Each gm contains:- Each 1000gm Water Soluble 500gm 50gm
Doxycycline Powder contains:- 1 Kg 100gm
HCI……………200mg Doxycycline HCI……….200g 25 Kg 500gm
Tylosin Tylosin Tartrate HCI…....100g 1000gm
Tartrate…………….100mg 5 Kg
25Kg
In
HDPE
Jar/
Sachet
5. 05717 Tithemycin Water Soluble Powder Tithemycin Water Soluble 150gm 25gm
6 Each gm contains:- Powder. 500gm 50gm
Neomycin…………….28.59%. Each 1000gm contains:- 1 Kg 100gm
Neomycin sulphate equivalent 5 Kg 500gm
to 285.9gm of Neomycin Base 25 Kg 1Kg
5 Kg
Sachet/
Jar
6. 05717 Tithechlore 20% Water Soluble Tithechlor 20% Water Soluble 150gm 25gm
7 Powder Powder. 500gm 50gm
Each gm contains:- Each 1000gm contains:- 1Kg 100gm
Chlortetracycline …200mg Chlortetracycline 25Kg 500gm
Hydrochloride……………..200 1Kg
g 5 Kg
Sachet/
Jar
7. 04958 Enroban Water Soluble Liquid Enroban Water Soluble Liquid 100ml 25ml
3 Each ml contains:- Each 100ml contains:- 500ml 50ml
Enrofloxacin……………200mg Enrofloxacin……………20gm 1 Litre 100ml
25 Litre 250ml
500ml
1000ml
5 Litre
10 Litre
25 Litre
Bottle/
can.
M/s. Zoic International, Lahore has deposited the required fee Rs.20,000 x 7 = 140,000/-
for above products and submitted following supporting documents:-
(i) Original & legalized NOC from manufacturer abroad M/s. Tithebarn Ltd UK
permitting manufacturing and marketing of the above mentioned products by M/s.
Zoic International, Lahore, Plot # 573, Sunder Industrial Estate, Multan Road,
Lahore in Pakistan.
(ii) Copies of registration letter.
(iii) Copies of renewal status.
(iv) Copy of Drug Manufacturing License M/s. Zoic International, Lahore.
(v) Copy of approved sections.
(vi) Copy of cGMP certificate.
(vii) Copy of deposited CRF.
(viii) Applications on prescribed Form -5.
The request of M/s. Zoic International, Lahore for change of status of registration of the
above mentioned drugs from import to local manufacture as per detailed provided above is
Decision:- Registration Board decided as follow:

a. Cancelled the registration of products at Sr.No.1-7, registered for
import in finished form, from the name of M/s. Zoic International,
Lahore.
b. Approved the registration of products at Sr.No.1-7, with pack sizes as
per previous registration letter, in the name of M/s. Zoic International,
Lahore, Plot # 573, Sunder Industrial Estate, Multan Road, Lahore for
local manufacturing at their licensed premises having DML No.000832.
Case No.6 Request of M/s. Forward Solutions, Lahore for Change of Address.
M/s. Forward Solutions, Lahore has requested for change of address from Plot No. 66-
West Wood Colony Thokarr Niaz Baig, Lahore to Plot No. 19-B Qazalbash Chowk, Abdul
Sattar Edhi Road , Lahore are as under:-
S. Regn. Name of drug(s) Composition. Remarks

No. No.
1. 078290 Lincomicina 150 Ganadexil Oral Powder Registration letter issued
Each gram contains:- with address:
Lincomycin (as Hcl)….150mg M/s. Forward Solutions,
80-A, Judicial
Colony,Thokar Niaz
Baig, Lahore
2. - DOXINYL Oral Solution 100mg/ml Approved in (M-278)
To be used with drinking water meeting with address of
Each ml contains: importer as 67 west
Doxycycline (as hyclate)…….100mg wood society, Main
Canal Road, Lahore.
M/s. Forward Solutions, Lahore has deposited required fee of Rs.5,000/- and submitted
following supporting documents:-
(i) Copy of registration letter.

(ii) Copy of Drug Sale License.
Decision:- Registration Board deferred the case for clarification that whether there is
any change in proprietor-ship of the firm.
Case No.7 Request of M/s. U.M. Enterprises, Karachi for Correction of Composition
Tylosin AVICO Water Soluble Powder (Regn. No. 088149).
M/s. U.M. Enterprises, Karachi has requested for correction of composition of their
following registered imported veterinary drug as per details mentioned against each:-
S. Regn. Product Composition Approved Demanded Composition as per
No. No. in 260th meeting CoPP
1. 088149 Tylosin AVICO Water Soluble Tylosin AVICO Water Soluble
Powder Powder
Each 100gm contains:- Each 100gm contains:-
Tylosin Tartrate …..……100mg Tylosin Tartrate …..……100gm
(As per Innovator's Specification*) (As per Innovator's Specification*)
M/s. U.M. Enterprises, Karachi has deposited required fee of Rs.5,000/- and submitted
following supporting documents:-
(i) Copy of registration letter.

(ii) Revised Form-5.
Decision:- Registration Board approved the correction in composition of Registered
product Tylosin Avico Water Soluble Powder (Reg.No.088149) as per
following details. Other terms and conditions remains the same.
Corrected Composition (as per CoPP)
Tylosin AVICO Water Soluble Powder
Each 100gm contains:-
Tylosin Tartrate …..……100gm
(As per Innovator's Specification*)
Case No.8 Request of M/s. Hassan Brothers, Faisalabad for correction in pack
size of approved Drug(s).
Registration Board in its 275th meeting approved various products of M/s. Hassan
Brothers, Faisalabad manufactured by M/s. Samyang Anipharm Co. Ltd. Seoul, Korea with
various corrections. In One of the approved product Peperoxin Solution the pack size was
mentioned in Kg inadvertently by the applicant and the same was mentioned in the agenda and
minutes of the Registration Board‘s meeting as per following details:-
S.No. Name of Manufacturer/ Name of drug(s) & Decontrolled/ Shelf
Composition Packs Size Life
Importer
1. M/s. Hassan Brothers, Peperoxin Solution 500gm 3 years
Faisalabad. / Each Litre contains:- 1 Kg
manufactured by M/s. Pefloxacin………………100g 2.5 Kg
Samyang Anipharm Co. (as 5 Kg
Ltd. Seoul, Korea. Pefloxacinemethanesulfonate
……139.6g)
Excipients (Purified water
etc)………………………Q.S
The firm subsequently submitted revised Form-5A and deposited fee of Rs.5000/- for
making the correction in pack size as 500ml, 1Litre, 2.5Litre & 5Litre.
Registration Board in its 276th meeting decided to defer the case for clarification regarding
the demanded pack sizes i.e. 500ml, 1 liter, 2.5 liter and 5 liters as the demanded pack sizes are not
mentioned on the free sale certificate issued by Korean Authority provided by the firm.
The firm has now provided certificate of product registration from Ministry for
Agriculture Food and Rural Affairs of Republic of Korea mentioning pack sizes of 100ml, 500ml,
1 Litre & 20 Litre.
The representative of M/o. Food Security, in 280th meeting, pointed out that there is need
to review use of this molecule in veterinary practices especially with reference to development of
resistance in human. Accordingly the Board decided as follow:
“Registration Board deferred the case for further clarification from the firm
regarding the submitted certificate of product registration.
The Board further decided to place the molecule “Pefloxacin” before Working
Group on Veterinary Drugs for its review”
The firm has now informed that the demanded pack sizes i.e 100ml, 500ml , 1 litre and 20
Litre are in free sale in country of origin.
Decision:- Registration Board approved issuance of registration letter with the

correction in pack sizes of already approved product “Peperoxin Solution” of
M/s. Hassan Brothers, Faisalabad as per following details. Other terms and
conditions remains the same.
Previously approved Pack Sizes New approved Pack Sizes (corrected)
(as per Free sales certificate issued by
Korean authority)
500 gm 100ml
1 Kg 500ml
2.5 Kg 1 litre
5 Kg 20 Litre
Registration-II Section
Case No.9 M/S. Cibex Pharmaceuticals (Private) Limited F-405, S.I.T.E, Karachi-Pakistan.
Following products of M/s. Cibex Pharmaceuticals (Private) Limited F-405, S.I.T.E,

Karachi-Pakistan were considered in 245th meeting of Registration Board as per details given below:-
S/N Brand Name Type of Form Remarks on the Decision

(Proprietary name + Dosage Initial date, formulation (if any)
Form + Strength) diary including
Composition Fee including International status
Pharmacological Group differential in stringent drug
Finished product fee regulatory agencies /
Specification Demanded authorities
Price / Pack Me-too status
size GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator
1. Klegg Dry Powder Suspension Form-5 Biaxin of AbbVie Inc Approved. RB authorized
125mg/5ml Dated 30/04/14 Chairman for issuance of letter
Each 5ml of suspension (when Dy No: 616 Klaricid of Abbot after submission of following
reconstituted) contains:- Labs Karachi documents:
Clarithromycin….125mg 20,000/- 1. Source of taste masked
Antibiotic Pack of 60ml Source of taste granules / pellets.
Manufacturer bottle/ As per masked 2. Stability studies of zone IV-A/
PRC clarithromycin needs 3. Valid GMP certificate
to be submitted along (Legalized in case of import).
with the GMP of the 4. Requisite fee (in case of
source, COA and imported source)
requisite fee in case
of import of said
granules.
2. Solyst Gel 0.05% Form-5 Acutane of Roche Approved. RB authorized
Each gram contains Dated 30/04/14 USA Chairman for issuance of letter
Isotretinoin…..0.5mg Dy No: 568 after confirmation of
Anti-acne 20,000/- Isotrol cream of manufacturing facility of gel
USP Pack of 1‘s, Valor from directorate of Drug
10gm tube/ As Pharmaceuticals, Licensing.
per PRC Islamabad
3. Perthyn Cream Form-5 Lyclearc Dermal Approved. RB authorized
Each gram contains:- Dated 30/04/14 Cream of (Chefaro Chairman for issuance of letter
Permethrin…..50mg Dy No: 548 UK) after confirmation of
Scabicide 20,000/- manufacturing facility of gel
Manufacturer Pack of 1‘s, Methrin of Medera from directorate of Drug
30gm tube/ As Pharmaceuticals Licensing.
per PRC Islamabad
4. Zacila Gel Form-5 Bonjela (BNF 61) Approved. RB authorized
Each gram contains:- Dated 30/04/14 Chairman for issuance of letter
Choline Salicylate….87.14mg Dy No: 603 Bonjela of Reckitt & after confirmation of
Cetalkonium Chloride….0.1mg 20,000/- Benckiser Pakistan manufacturing facility of gel
Antibacterial Pack of 1‘s, Karachi from directorate of Drug
Manufacturer 20gm tube/ As Licensing.
per PRC
5. Civaz Cream Form-5 Silvadene of Pfizer Approved. RB authorized
Each gram contains:- Dated 30/04/14 Inc Chairman for issuance of letter
Silver Sulphadiazine….10mg Dy No: 569 after confirmation of
Antibacterial 20,000/- Quench cream of manufacturing facility of gel
USP Pack of 1‘s, Ferozsons Hattar. from directorate of Drug
20gm & 50gm/ Licensing.
As per PRC
6. Pamitra Cream Form-5 PanOxylc Cream of Approved. RB authorized
Each gram contains:- Dated 30/04/14 Stiefel (BNF 61) Chairman for issuance of letter
Benzoyl Peroxide….40mg Dy No: 597 after confirmation of
Antiacne 20,000/- Aknekream of manufacturing facility of gel
Manufacturer Pack of 1‘s, Werrick Labs from directorate of Drug
40gm/ As per Islamabad Licensing.
PRC
7. Nazuk Plus Cream Form-5 Tri Luma Cream Approved with change in brand
Each gram contains Dated 30/04/14 approved by FDA name. RB authorized Chairman
Hydroquinone…..40mg Dy No: 571 for issuance of letter after
Fluocinolone as 20,000/- Hydroquin Plus of confirmation of manufacturing
acetonide…0.1mg Pack of 1‘s, ATCO Labs Karachi facility of gel from directorate of
Tretinoin….0.5mg 15gm tube/ As Drug Licensing.
Anti-inflammatory, Anti- per PRC
infective
Manufacturer
8. Basizon-NN Cream Form-5 Dermovate NN of Approved. RB authorized
Each gram contains:- Dy No: 600 Chemidex (BNF 61) Chairman for issuance of letter
Clobetasol propionate….0.5mg Dated: 30-04- after confirmation of
Neomycin Sulphate…5mg 14 Dermovate NN of manufacturing facility of gel
Nystatin…..100,000 Units 20,000/- GSK Karachi from directorate of Drug
Anti-inflammatory As per PRC/ Licensing.
Manufacturer Tube of 20gm
9. Buxton-N Cream Form-5 Betnovate N of Approved. RB authorized
Each gram contains:- Dy No: 570 Chemidex Chairman for issuance of letter
Betamethasone as Dated: 30-4-14 after confirmation of
Valerate…..1mg 20,000/- Betacin-N of manufacturing facility of gel
Neomycin as Sulphate….5mg As per PRC/ Geofmann from directorate of Drug
Anti-infective Tube of 20gm Pharmaceuticals Licensing.
Manufacturer
10. Buxton-N Ointment Form-5 Betnovate N of Approved.

Each gram contains:- Dy No: 598 Chemidex
Betamethasone as Dated: 30-4-14
Valerate…..1mg 20,000/- Betnovate-N of GSK
Neomycin Sulphate….5mg As per PRC/ Karachi
Anti-infective Tube of 20gm
Manufacturer
11. Fisker Cream 0.025% Form-5 Fluoderm of Taro Approved. RB authorized
Each gram contains:- Dy No: 596 Pharmaceuticals, Chairman for issuance of letter
Fluocinolone Dated: 30-04- Canada. after confirmation of
Acetonide……0.25mg 14 manufacturing facility of gel
Corticosteroid 20,000/- Synalar of Pharma from directorate of Drug
USP As per PRC/ Health Pakistan Licensing.
Tube of 30gm
Now the firm has provided source of pellets as M/s. Vision Pharmaceuticals Plot No. 22-
23, Industrial Triangle, Kahuta Road, Islamabad and documents from Licensing Davison for
confirmation of manufacturing facility and has requested to grant them registration of above
products.
The PRVC in its 6th meeting decided to refer the case to Registration Board.
Decision: Registration Board approved the registration of products mentioned at Sr.no.
01 to Sr.no. 11 of the above table in the name of M/S Cibex Pharmaceuticals
(Private) Limited F-405, S.I.T.E, Karachi-Pakistan. The source of pellets for
Clarithromycin at Sr.no. 01 will be M/s Vision Pharmaceuticals, Plot No. 22-
23, Industrial Triangle, Kahuta Road, Islamabad.
CASE NO. 10 CORRECTION IN REGISTRATION LETTER OF M/S. AGP LIMITED B-23-C,
S.I.T.E., KARACHI. DY NO. 24624 DATED 14-12-2017
M/s. AGP Limited B-23-C, S.I.T.E., Karachi was granted the registration of
following product vide letter dated 03-11-2017. There is typographical error in the address of the
firm mentioned in registration letter as per following details while the title of the firm was
changed from M/s. AGP (Pvt.) Ltd, B-23, SITE Karachi (DML No. 000348) to M/s. AGP
Limited B-23-C, S.I.T.E., Karachi (DML No. 000348) vide letter dated 29-12-2016. (M-251):-
S.No. Reg.No. Name of Drug(s) Existing Address Correct Address
1. 085616 Maxna 100mg/ml M/s. AGP (Pvt.) Ltd, M/s. AGP Limited B-
Injection B-23, SITE Karachi 23-C, S.I.T.E., Karachi
DML No. 000348 (DML No. 000348)
Each ml contains:-
Tranexamic Acid …
100mg
(BP Specificaton)
The PRVC in its 6th meeting decided to refer the case to Registration Board.
Decision: Registration Board acceded to the request of the firm for issuance of
registration letter of Maxna 100mg/ml Injection (Reg.No. 085616) in the
correct address of M/S AGP Limited, B-23-C, S.I.T.E Karachi.
CASE NO. 11 CORRECTION IN SPECIFICATIONS OF M/S. PHARMEVO (PRIVATE)

LIMITED A-29, NORTH WESTERN INDUSTRIAL ZONE PORT. QASIM
KARACHI-75020. DY NO. 3397 DATED 26-01-2018
M/s. PharmEvo (Private) Limited A-29, North Western Industrial Zone Port.
Qasim Karachi-75020 has requested for correction in specifications of below mentioned drug as
per following details:-
S.No. Reg.No Existing approval(s) Demanded / Correct description

1. 086069 Nebivo 2.5mg Tablet Nebivo 2.5mg Tablet
Each tablet contains:- Each tablet contains:-
Nebivolol as hydrochloride … 2.5mg Nebivolol as hydrochloride … 2.5mg
(USP Specification) (As per *Innovator’s Specification)
Decision: Registration Board approved the correction in the finished specification of

Nebivo 2.5 mg Tablet (Reg.No. 086069) from USP Specification to Innovator’s
Specification.
Case No.12 NEW INDICATION FOR DUPHASTON 10MG TABLET (REG.NO.006654).
Registration Board in its 278th meeting held on 29-31st January, 2018, considered
the request of M/s Abbott Laboratories (Pakistan) Limited, Opp. Radio Pakistan Transmission
Centre, Hyderabad Road, Landhi, Karachi-75120 for new indications of the ―Duphaston 10mg
Tablet‖ (Reg.No.006654) and decided as under:-
Registration Board acceded to the request of the firm and approved the new
indication „Assisted Reproductive Technology (ART)‟ for Duphaston 10mg Tablet
that was based upon the approval granted to the product by Netherlands.
The letter has been issued with correct indication as i.e support the luteal phase as a part of an
Assisted Reproductive Technology (ART)’ for said drug that was based upon the approval
granted to the product by Regulatory Authority of Netherlands.
Decision: Registration Board noted the information.
Case No. 13 Change of coating of Epival of M/s Abbott Laboratories, Karachi- Deferred in
275th Meeting. (For Acetone switchover to other solvents)
Background of the case:
M/s Abbott Laboratories (Pakistan) Limited, Karachi has requested for change of coating
material of Epival 250mg Tablet Reg. No. 007160 and Epival 500mg Tablet registration No.
007161 from Acetone to other solvent, Acryl-Eze. The firm has further stated that change in
coating of Epival 250mg tablet and Epival 500mg tablet will have no effect in existing label
claims, efficacy, quality and safety of these products.
2. In support the firm have provided following documents:
i) Current and revised formulations of Epival 250mg & Epival 500mg tablet.
ii) Protocols, Stability Data and Chromatograms of Epival 250mg & 500mg for all batches
(three trial batches & one Routine batch) with new aqueous coating material named Acryl-
Eze, Stability studies comply with the testing method and results are within specification
limits.
iii) Copy of registration letter with renewal status.
iv) NOC for CRF.
v) Evidence of approval from Reference regulatory Authorities for delayed release tablet.
vi) Undertaking to conduct stability studies for complete shelf life.
vii) Original Rs. 5000/- fee for each product.
Registration Board in its 275th meeting deferred the case for further deliberation in light of
processing of Controlled Drugs Division.
The matter was again presented in 279th meeting of Registration Board as per following details:-
“It is submitted that the above change in coating material was suggested by Controlled Drugs
Division of DRAP on 06-06-2016 with the advice to the firm that to strictly comply with times
lines submitted by the firm for switching over to other solvents with in 24 months and submit
quarterly progress report to their office and authenticate / get approval of formulation
changer from PE&R Division”.
The firm had provided approval status of delayed release tablet in US FDA and complete
prescribing information of Depakote delayed Release tablets. Furthermore, firm has requested that
change in coating of Epival 250 mg tablets and Epival 500 mg tablets will have no effect in the
existing label claims, efficacy, quality and safety of these products.
Now the firm has submitted Form-5 and differential fee of Rs. 15,000/- for each product and has
requested to grant approval of change in coating material / dosage form. However, the Form-5
provided by the firm is incomplete and do not contain specification and analytical methods.
Decision: Registration Board approved change in coating of Epival Tablets 250mg &
500mg Tablets from film coated to enteric coated tablets as per USP
specifications
Case No.14 Correction in Specification of Ezomol IV 40mg Injection Of M/S. Abbott

Labs, Karachi.
Back ground of the case:
Registration Board in 274th meeting approved the following product of M/s.
Abbott Labs, Karachi and subsequently registration letter was issued with USP Specification vide
(Reg.No.086081):-
Name and address of manufacturer / M/s. Abbott labs, opposite radio Pakistan transmission
Applicant center, industrial estate, Hyderabad road, Landhi Karachi
Brand Name +Dosage Form + Strength Ezomol IV 40mg (Lyophilized)
Esomeprazole sodium e. to Esomeprazole………40 mg
Type of Form Form-5
Pack size & Demanded Price 10 ml /As Per SRO
Approval status of product in Reference Esomeprazole of Consilient pharma (MHRA)
Me-too status ESSO-40 of shaigan
GMP status Panel inspection conducted on 14-01-2017 and report
concludes that firm is following the GMP guidelines.
Remarks of the Evaluator. Lyophilized section present
Decision :Approved
The case was presented in 278th meeting of Registration Board wherein the firm had informed that
above product is not yet included in any pharmacopeia, therefore they may be granted
Manufacturer / In-house Specification for above mentioned product. The Board decided as
follows:-
Registration Board deferred the case to confirm status of the product in
pharmacopeia of any reference regulatory authority approved by registration
board.
Decision: Registration Board approved correction in finished product specification as
per innovator’s specification for Ezomol IV 40mg Reg.No. 086081.
Case No.15 Confirmation of Registration Status
RRR section requested to confirm the registration status of following products. RRR has
informed that M/s Opal Laboratories, Karachi issued an NOC dated 13th October, 2009 to M/s
Akhai Pharmaceuticals, Karachi. Later on, M/s Opal Laboratories, Karachi vide a letter dated 12 th
November, 2014 cancelled the said NOC.
S.No Reg. No Name of Product Date of Registration
1 039224 Furalox Ds Tablet 26.05.2005
2 029319 Furalox Suspension 12.12.2002
3 029309 Ulcoat Suspension 1 gm/ 5ml 20.12.2012
4 029311 Lactil Syrup 67 gm/ 100 ml 20.12.2002
5 029318 Furalox Film Coated Tablet 12.12.2002
6 029310 Nexole Capsule 30 mg 20.12.2002
However, as per available record the products mentioned at S.No 1 -5 are registered in the
name of M/s Opal Laboratories, Karachi. Whereas, product at S.no 6 was registered in the name
of M/s Akhai Pharmaceuticals, Karachi. Furthermore, the said NOC dated 13th October, 2009 and
cancellation of NOC after 5 years dated 12th November, 2014 could not be traced. On above
mentioned basis, M/s Opal Laboratories have applied for renewal of products at S.No 1-5 and
RRR requested for confirmation of registration status.
Registration Board deliberated on the matter in its 275th meeting and decided to provide
opportunity of personal hearing to M/s Opal Laboratories for clarification regarding issuance of
NOC and its cancellation after 05 years in the forthcoming meeting. Accordingly, M/s. Opal
Laboratories, Karachi has been called for personal hearing.
Decision: Registration Board was appraised by representative of management of M/s

Opal Laboratories, Karachi that previous management had given the NOC
for change of registration status of above mentioned products which was then
cancelled except for product at sr.no 6 that was transferred to M/s Akhai
Pharmaceuticals, Baluchistan. He further informed that now M/s Opal has
applied for renewal of product at Sr.no. 4 (Lactil Syrup Reg.No. 029311)
under S.R.O. 1117(I)/2017 of RRR. Registration Board deferred the case for
verification of claim of firm regarding above products and directed RRR
section to check whether the firm has submitted renewal for products at sr.no
1-3 and 5 and present complete case in the forthcoming meeting with updated
status.
Case No.16 CHANGE OF MANUFACTURER (TITLE REMAIN THE SAME).
M/s GlaxoSmithKline Pakistan, Karachi has applied for change in manufacturing

site of following products from West Wharf Site (DML No. 000017) to Korangi Site (DML No.
000248) as per following details. The reference was sent to RRR section for confirmation of
Renewal status of following products, which is mentioned in last column:
S. Existing New Reg. No. Name of drug(s) & Initial registration with
No. manufacturer manufacturer Composition date and renewal status
(DML NO. (DML No.
000017) 000248)
1. M/s. M/s. 000351 Amphyll Injection Initial registration
GlaxoSmithKli GlaxoSmithKl dated 17.04.1976
ne Pakistan, ine Pakistan,
Original renewal
West Korangi Site,
application received with
Wharf,Karachi Karachi
in stipulated time period
Clarification of
manufacturing site
required
2. -do- -do- 066732 Water for Injection i)Initial registration
Each ampoule dated 24.09.2010
contains: Original renewal
Water for Injection application received with
......….2ml in stipulated time period
(USP Specification)
.......….3ml in stipulated time period
(USP Specification)
.......….5ml in stipulated time period
(USP Specification)
5. -do- -do- 10666 Amikin i)Initial registration
Injection100mg dated 31.03.1990
Contains: ii) Original renewal
Amikacin Sulphate application received with
….100mg in stipulated time period
6. -do- -do- 005488 Amikin Injection i)Initial registration
500mg/ml dated 25.04.1984
Each 2ml contains: ii) Original renewal
Amikacin…….500 application received with
mg in stipulated time period
Clarification of
formulation required
7. -do- -do- 005487 Amikin Injection i)Initial registration
250mg/ml dated 25.04.1984
Each 2ml contains: ii)1st Transfer of
Amikacin…….250 Registration 01.10.2010
mg iii) Original renewal
application received with
in stipulated time period
Clarification of
formulation required
8. -do- -do- 076289 Ligocaine 1 % Renewal not due
Injection
Each 1 ml contains:
Ligocaine HCl
.........…. 10 mg
In support of their claim the firm has provided following documents:

i) Application with prescribed fee amounting to Rs. 20,000/- for each products
ii) Registration letter and renewal status.
iii) NOC for CRF
iv) Renewal of DML 000248 Korangi
v) Last inspection report dated 25.03.2014
Also M/s GSK, Karachi have provided an undertaking for clarification of postal address
mentioned on transfer of registration letters, which was their head office address
Registration Board decided the case in its 268th meeting as follows:-
 Cancellation of registration of products at S.No 02-08 from the name of M/s

GlaxoSmithKline Pakistan, West Wharf, Karachi (DML NO. 000017).
 Approved the grant of registration of products at S.No 02-08 in the name of M/s.
GlaxoSmithKline Pakistan, Korangi Site, Karachi (DML No. 000248).
 Reference will be sent to Cost and Pricing Division for fixation of MRP before
 Deferred products at S.No.2 and 8 for clarification of composition.
It is submitted that the registration letter of product at Sr.No. 3-5 has been issued to the firm.
While preparing the minutes of the meeting the product at Sr.No. 2 & 8 were mistakenly
mentioned as deferred instead products at Sr. No. 1 & 7, which may be correct accordingly.
Decision: Registration Board noted the information for correction in the minutes of
269th meeting of Registration Board.
Case No. 17 Change of Finished Product Specification
M/s Otsuka Pakistan Ltd., have applied for change of specification of their product as per
following details:
S.No Reg.No. Name of Drugs & Composition Existing Proposed

Specification Specification
1 086879 Otsuzol IV Infusion 100 ml USP BP
Each 100 ml contains:-
Metronidazole… 500 mg (0.5 % w/v)
2 086880 Otsuflox IV Infusion 100 ml USP BP
Each 100 ml contains:-
Ciprofloxacin Lactate eq. to
Ciprofloxacin… 200 mg
The firm has requested that they submitted Form-5 with BP Specifications. However, registration
certificate issued on 18th January, 2018 (M-274) contains USP Specification. Therefore, it is
requested to please rectify this error.
Decision: Registration Board deferred the case for verification of the claim by the firm
from the original dossier.
Csae No. 18 Request for Extension of Permission Of Bulk Import & Local Repacking Of
Drug(S) Of M/S. Atco Laboratories, Karachi
M/s. Atco Laboratories Ltd; Karachi has requested for extension of permission of bulk
import and local repacking of their following already registered products:-
S.No. Name of Drug(s) with existing Reg.No. Registration history

formulation
1. Hirudoid Cream 100gm 014995 The firm was granted previous

extension of permission for bulk import
Each 100gm contains:- & local repacking on 13-12-2012 which
was valid till 5 years. The approved
Mucopolysacchride Polysulfuric acid manufacturer was Sankyo Pharma
ester … 0.3gm GmBH, Germany.
2. Hirudoid Gel 100gm 017481 -do-
Each 100gm contains:-
Mucopolysacchride Polysulfuric acid

ester … 0.3gm
They have further stated that have equipped their facility to manufacture the above product
and the manufacturer did not allow them to manufacture these products locally in Pakistan. They
have therefore, requested to extend the permission of bulk import and local repacking for further 5
years.
The management of the firm has provided following documents:-

i. Original challans of fee of Rs. 1,00,000/- per product for this purpose.
ii. Copies of initial letters of registration and subsequent permission letters.
The Committee in its 3rd meeting deferred the case for provision of complete documents
as per approved SOPs and placement before Registration Board. Now the firm has provided
original & legalized CoPP and requested for extension of bulk import and local repacking
permission as requested above.
As per CoPP provided by the firm for the above products following information has been
retrieved:-
S.No. Name of active ingredient Name of Manufacturer Product License Holder
1 100 g ointment contains:- Mobilat Produktions STADA GmbH

GmbH Luipoldsrarβe 1 Stadastraβe 2-28 D-61118
300 mg Chondroitin polysulfate 85276 Pfaffenhofen Bad Vibel, Deutschland.
from Bovine tracheal cartilage 300 Germany.
gm corresp. 25000 U
Units determined by means of the

activated partial thromboplastin time
(APTT).
2. 100 g Gel contains:- Mobilat Produktions STADA GmbH

GmbH Luipoldsrarβe 1 Stadastraβe 2-28 D-61118
300 mg Chondroitin polysulfate 85276 Pfaffenhofen Bad Vibel, Deutschland..
from Bovine tracheal cartilage 300 Germany.
gm corresp. 25000 U
Units determined by means of the

activated partial thromboplastin time
(APTT).
The manufacturer is Mobilet Productions GmbH, Germany.
Decision: Registration Board deferred the case and advised the firm to confirm whether
the composition mentioned in the initial registration letter and composition
mentioned in the CoPP is same.
Case No. 19 Registration of Drug Products:
Registration Board in its various meeting approved the following products in favour of
M/s Merck (Private) Limited, 7, Jail Road, Quetta. Now the firm has informed that the name of
the firm has been changed from M/s Merck (Private) Limited, 7, Jail Road, Quetta to M/s. Martin
Dow Marker Limited 7, Jail Road, Quetta. The firm has requested to issue the registration letter of
below mentioned products on new name of the firm:-
S.No. Name of Drug(s) with Demanded References Decision of Registration

formulation pack size Board
and MRP
1. Lumairia Dry Suspension 16-11-2011 WHO 260

Dy.No.361 recommended Approved. Photocopy fee
Each 5ml of reconstituted Form 5 formulation challans will be verified by
suspension contains Rs.8000/- Budget & Accounts Division
Rs.12,000/-
Artemether 15mg and Chairman Registration
05-09-2013
Lumefantrine 90mg Board will permit issuance of
(Photocopy) Artem – Hilton registration letter
(Antimalarial) Pack size
Manufacture specification
30ml  Rs. GMP compliant
90/- section
2. Lumairia Tablet 80/480 16-11-2011 WHO 260
Each Tablet contains Form 5 formulation challanswill be verified by
Artemether 80mg Rs.8000/- Budget & Accounts Division
Rs.12,000/-
Lumefantrine 480mg and Chairman Registration
05-09-2013
Board will permit issuance of
(Antimalarial)
(Photcopy) Artem – Hilton registration letter
Manufacture specification Pack size GMP compliant
section
30ml  Rs.
90/-

Rs.12,000/-
Lumefantrine 240mg and Chairman Registration
05-09-2013
(Antimalarial)
(Photocopy) Artem – Hilton registration letter
Manufacture specification Pack size GMP compliant
section
10s  Rs.
264/-

Lumefantrine 120mg Rs.12,000/- Artem – Hilton and Chairman Registration
05-09-2013
(Photocopy) GMP compliant
(Antimalarial) registration letter
Manufacture specification section
Pack size
16s  Rs.
320/-
5. Pexam 5mg Tablet Form 5 Cipralex/Lexapro 265

Dy.No. Nil by Lundbeck
Rs.8000/- USA Approved With USP
15-06-2011 Espram by Specification.
Each Film coated tablet Pharmatec
contains: Rs 12000/ Last inspection Reference Will Be Sent To
20-01-2013 report on 13th Budget & Accounts Division
Escitalopram Oxalate….5 For Verification Of Challan
mg Duplicate and 14th May
Dossier 2016 granted And Chairman Registration
14‘s revalidation of Board shall authorize issuance
Rs. 112/- DML by the way of registration letter
(Anti-Depressant) of formulation,
approved
changes made by
the firm as per
layout plan for
attaining the
better level of
GMP compliance
by Lundbeck
Dy.No. Nil USA Approved with USP
specification.
Each film coated tablet Rs.8000/- Espram by
contains: Pharmatec Reference Will Be Sent To
15-06-2011 Budget & Accounts Division
Escitalopram Oxalate….20 Last inspection For Verification Of Challan
mg report on 13th And Chairman Registration
Duplicate and 14th May Board shall authorize issuance
Dossier 2016 granted of registration letter
(Anti-Depressant) revalidation of
14‘s DML by the way
of formulation,
Rs. 322/- approved
changes made by
the firm as per
layout plan for
attaining the
better level of
GMP compliance

Dy.No. Nil by Lundbeck Approved with USP
Each film coated tablet USA specification.
contains: Rs.8000/- Espram by Reference Will Be Sent To
Escitalopram Oxalate….10 15-06-2011 Pharmatec Budget & Accounts Division
mg Last inspection For Verification Of Challan
Duplicate report on 13th And Chairman Registration
(Anti-Depressant) and 14th May Board shall authorize issuance
14‘s 2016 granted of registration letter
Rs. 238/- revalidation of
DML by the way
of formulation,
approved
changes made by
the firm as per
layout plan for
attaining the
better level of
GMP compliance
8. Sustin 20mg Tablet Form-5 Crestor-MHRA
Each film coated tablet Dy.#192 Rolip-Hilton 267Approved with Innovator‘s
contains: dated Pharma specs. Reference will be sent to
Rosuvastatin Calcium eq. 23-09-11 Last inspection Budget & Accounts Division
to Rs.8000/‐ report on 13th for verification of challan and
Rosuvastatin ………20 mg (Duplicate and 14th May Chairman registration Board
(Lipid‐Lowering Agent) challan) 2016 granted will authorize issuance of
20‐09‐2011 revalidation of registration letter
Rs.12,000/‐ DML by the way
(Duplicate of formulation,
challan) approved
31-07-2013 changes made by
Rs. 40/ the firm as per
tablet layout plan for
attaining the
better level of
GMP compliance
9. Tablet Osteolock Form 5 Gevolox –Hilton Decision: 268-M
Each film coated tablet Dy # 1728 GMP compliant Approved with USP
contains 05-11-2012 section vide specifications. Reference
Glucosamine Sulphate Rs.20,000/- inspection report will be sent to Budget &
2KCl USP eq. to (Photocopy) dated 13-14th Accounts Division for
Glucosamine Sulphate Pack size May, 2016 verification of challan and
500mg 20‘s Chairman will authorize
Chondroitin Sulphate USP - issuance of registration
..........400mg letter.
(Osteoarthritis)
The management of the firm has deposited fee of Rs. 20,000/- for each product.
Decision: Registration Board approved the registration of prducts mentioned at Sr.no.

1-9 of the above table in the new title of the firm i.e. M/s MartinDow Marker
Limited, 7 jail road, Quetta.
Case No.20 Interim Permission for packing of Fefol Spansules of GSK West Wharf from
GSK F-268 SITE Karachi
M/s GSK Pakistan West Wharf, Karachi requested for the packaging of their registered
product Fefol Spansules from M/S GSK, F-268, Karachi as they have to fulfil the requirement of
Punjab Government‘s tender requirement. Registration Board in its 276th meeting considered the
request and decided as follows:
“Registration Board deliberated that reference of Government of Punjab has

mentioned supply of said product from either manufacturing site and M/s GSK, Karachi is
asking for two manufacturing sites. The Board decided to defer the case for further
clarification for manufacturing sites and relevant rule status.”
The case was again discussed in 277th meeting of Registration Board and Board deferred
the case for opinion of Legal Division. The case was again discussed in the 278th meeting of the
Board where Registration Board decided as follows:
“Registration Board deliberated the matter in detail. Mr. Amer Lateef, Deputy
Director (Legal Affair) also participated in the discussion. He opined that instant request
can be considered as per provision of Rule 20A (1)(c) of Drugs (L, R & A) Rules, 1976.
The Board deliberated on the matter and it was decided to constitute committee
comprising Director, DTL, Karachi, Director, CDL, Karachi and Mr. Afnan Ali, Assistant
Director, CDL Karachi to determine packaging capacity on 24 hours‟ basis of M/s GSK
F-268 SITE, Karachi, GSK Dockyard Road West Wharf (DML # 000017). The Board
further advised to issue letter in this regard immediately and as this is a time limit case
that requires prompt action to ensure availability of Fefol Spansules as required by
Government of Punjab.”
Now the panel comprising of following experts visited the premises on 20-03-2018 and
submitted their report for consideration of the Registration Board vide letter No.1-1/2013-DRAP
(CDL)/SRK-222 dated 03rd April, 2018:
1. Dr. Saif Ur Rehman Khattak, Director, CDL, Karachi
2. Mr. Syed Muzafar Ali Jafri, Director, DTL, Sindh, Karachi
3. Dr. Affan Ali, Assistant Director, CDL, Karachi
Documents Reviewed:
The following documents were reviewed in connection with the case. All the documents were
found satisfactory:
1. Document for change control

2. Risk assessment of whole change
3. Protocol on performance qualification of packaging operation at F-268 site
4. Protocol on validation of Spansules transfer process
5. Hold time study
6. Documents on sampling process, in-process checks, physical inspection criteria and
reconciliation.
7. Label and labelling of the product.
8. Qualification of personnel supervising the manufacturing and packaging operations of Fefol
Spansule at both sides.
9. Technical specifications and capacity of blister machines installed at both sites.
10. Last three years sales record of Fefol Spansules.
11. Accelerated and real time stability studies related to initial three commercial batches and
current year ongoing study.
Observations noted during Physical Inspection of Both Sites:
Both sites of GSK were physically inspected by the panel on 20-03-2018. The following
observations were noted:
1. GSK West Wharf has sufficient facility to produce Fefol Spansules in quantities as desired by
the Punjab Government in addition to their regular market supply.
2. The blister machines at both sites have similar technology and technical specifications.
3. The environmental conditions and air cleanliness are same in blister sections at both sites.
4. The supervision of blistering and packaging operations at both sites are made by proper
qualified persons.
5. Available facilities for in-process checks at F-268 site are similar and comparable to that at
west wharf.
6. Proper facilities are available for transportation of Fefol Spansules from west wharf site to F-
268 site under controlled conditions and supervision.
Conclusions and Recommendations:

On the basis of facilities for production and quality control at both sites, related studies already
undertaken OR planned, measures and controls proposed for implementation during
manufacturing, transportation and packaging it is concluded that packaging of Fefol Spansules
can be conducted at F-268 site with the same quality as that at west wharf site.
Hence, panel recommends the approval of packaging operations of Fefol Spansules at GSK
F-268 site in addition to GSK west wharf site as special permission to supply to the
Government of Punjab.
The panel further recommends that:
1. The approval should only be given for supply of the product to the government of Punjab for
the requested period i.e. 06 months.
2. The packs should be strictly labelled as per Drugs (Labelling and Packing) Rules, 1986.
3. Process control and in-process testing should be carried out at west wharf and F-268 sites
whereas final testing and release should be carried out by the west wharf site.
4. Packaging at F-268 should be supervised by proper qualified persons.
5. Transportation validation, packaging process validation and holding time studies at F-268 site
should be conducted as per designed protocols and result be also submitted to the panel and
DRAP Islamabad.
6. Shifting of unpacked Fefol Spansules from west wharf to F-268 site should be made in such a
manner so that there is short holding for the up-packed capsules at F-268 site.
7. Packaging of the batches at F-268 should be completed in one go.
8. The first three batches packed at F-268 site should be placed at accelerated and real time
studies and Punjab Government and DRAP, Islamabad should be informed immediately in case of
any significant change.
9. The concerned stability studies should be conducted at west wharf site to avoid validation of
stability indication method and analyst(s) involved.
Furthermore, in continuation to previous report a letter from the abovementioned expert is
received dated 06th April 2018 with the following content:
―it is submitted that the firm has to supply around 196 batches of Fefol capsules each of 22000
packs to Government of Punjab within six months period. The panel thoroughly evaluated the
packaging capacity of M/s GSK West Wharf Karachi for Fefol Capsules. The technical and
administrative evaluation revealed that only half of the batches can be packed at West Wharf
facility as the firm has also appreciable requirements of the drug for regular commercial supply.
Keeping in view the time limited supply for the Government of Punjab and constraints of the
facility for packaging of the drug GSK F-268 site was recommended for packaging of remaining
half of the batches.”
Decision: Registration Board keeping in view the letter of Punjab Government for No
objection on the packaging of Fefol Vit Spansules from either site of GSK
Pakistan(WestWharf, Karachi and F-268, SITE Karachi) and
recommendations given by the inspection panel decided as follows:
The Board granted one time packaging permission to M/s GlaxoSmithKline,
West Wharf, Karachi for 196 batches (each of 22,000 packs) of Fefol
Spansules from M/s GlaxoSmithKline, F-268 site, Karachi in order to meet
Punjab Government tender requirements, under Rule 20A (c) of Drugs
(Licensing, Registering and Advertising) Rules, 1976 with the following
conditions:
i. The packs should be strictly labelled as per Drugs (Labelling and Packing)
Rules, 1986.
ii. Process control and in-process testing shall be carried out at west wharf
and F-268 sites whereas final testing and release should be carried out by
the west wharf site.
iii. Packaging at F-268 should be supervised by proper qualified persons.
iv. Transportation validation, packaging process validation and holding time
studies at F-268 site shall be conducted as per designed protocols and
result be also submitted to the inspecting panel and DRAP Islamabad.
v. M/s GSK shall ensure shifting of unpacked Fefol Spansules from west
wharf to F-268 site in such a manner so that there is short holding for the
up-packed capsules at F-268 site.
vi. Packaging of the batches at F-268 should be completed all at once.
vii. First three batches packed at F-268 site shall be placed at accelerated and
real time studies and Registration Board and Punjab Government shall be
informed immediately in case of any significant change about result of
stability studies.
Case No. 21 CORRECTION IN FORMULATION OF DRUG(S) OF M/S. MISSION
PHARMA, KARACHI.
Following product of M/s. Mission Pharma, Karachi was approved with B.P
Specification in 269th meeting of Registration Board with Glucose 1.00 m.mol/L. Therefore,
registration letter of the following product could not be processed due to unavailability of price as
MRP of formulation with Glucose 1.1 gm was available only in 9th PAC. The firm has informed
that there is some typographical error in the formulation of drug as per following details:-
Approved formulation Applied / correct formulation

Renal Cure Concentrate 35X (RC-102-RB) Renal Cure Concentrate 35X (RC-102-RB)
Part-A (solution) + Part-B (Powder) Part-A (solution) + Part-B (Powder)
For Bicarbonate Haemodialysis. For Bicarbonate Haemodialysis.
Each per unit, e.g each tablet or 5ml, etc. contains: Each per unit, e.g each tablet or 5ml, etc.
After finally mixing/diluting 35X Haemodialysis contains:
machines with De-ionized water, the strength of active After finally mixing/diluting 35X
ingredients of Part-A & Part-B Haemodialysis concentrate Haemodialysis machines with De-ionized
are: water, the strength of active ingredients of
Sodium 138.0 … m.mol/L Part-A & Part-B Haemodialysis concentrate
Potassium ...2.00 m.mol/L are:
Calcium….1.25 m.mol/L Sodium 138.0 … m.mol/L
Magnesium …. 0.50 m.mol/L Potassium ...2.00 m.mol/L
Chloride ….. 108.50 m.mol/L Calcium….1.25 m.mol/L
Acetic Acid ….. 3.00 m.mol/L Magnesium …. 0.50 m.mol/L
Bicarbonate …..32.0 m.mol/L Chloride ….. 108.50 m.mol/L
Glucose ..…1.00 m.mol/L Acetic Acid ….. 3.00 m.mol/L
Calculated Osmolarity 291.00 mosm / L Bicarbonate …..32.0 gm/L
(EU. Phr. Specification) Glucose ..…1.00 m.mol/L
Decision of 269th meeting: Approved with BP specifications Calculated Osmolarity 291.00 mosm / L
(B.P Specification)
The management of the firm has requested for correction in the minutes and issuance of
registration letter with correct formulation.
Decision: Registration Board deferred the case and advised the PE&R Division to
confirm whether Glucose 1.1 gm/L is equivalent to Glucose 1.00 mmol/L. If
not, the above formulation will be treated as new drug application and the
case will be processed in accordance with the SOPs defined for the purpose.
Registration-III Section
Case No.22 Transfer of registration from M/s Wenovo Pharmaceuticals, Taxila to M/s
Walt Danzay Pharmaceutical, Taxila alongwith contract manufacturing
permission.
M/s Walt Danzay Pharmaceuticals Pharmaceutical, Plot No. 35-A Small Industrial
Estate, Taxila have requested for transfer of following already registered products from the name
of M/s Wenovo Pharmaceuticals, Plot # 31 & 32 Punjab Small Industrial Estate, Taxila to their
name alongwith permission for contract manufacturing by M/s Wenovo Pharmaceuticals, Taxila.
S.# Reg. Brand Name with Initial Dy. No. and Status in reference
No. Generic Registration date drug agencies
Letter Date and
Renewal Status
1. 085367 Xilporin 125mg/5ml 17-10-2017 409 DDC R-  ANSM-France
Dry Suspension. (Renewal due: III  Evacef Suspension
Each 5ml 16-10-2022) 13-02-2018 125mg/5ml by M/s
reconstituted Highnoon
suspension contains:- Laboratories
Cefadroxil (as
monohydrate)
……….125mg
(USP Specifications)
2. 085368 Xilporin 250mg/5ml 17-10-2017 408 DDC R-  ANSM-France
Dry Suspension (Renewal due: III  Evacef Suspension
Each 5ml 16-10-2022) 13-02-2018 250mg/5ml by M/s
reconstituted Highnoon
suspension contains:- Laboratories
Cefadroxil (as
monohydrate)
……….250mg
3. 077891 Xilporin 500mg 17-06-2014 400 DDC R-  UK-MHRA
Capsules (Renewal due: III  Roxif capsules
Each capsule contains: 16-06-2019) 13-02-2018 500mg of legacy
Cefadroxil (as Approval for Pharma
monohydrate) change in brand
……….500mg name from
(USP Specifications) Bydroxil to
Xilporin :
07-09-2017
4. 078024 Pimazon Injection 16-09-2014 406 DDC R-  USFDA Approved
1gm (Renewal due: III  Maxipime 1gm
Each vial contains: 15-09-2019) 13-02-2018 Injection by M/s
Cefepime as Approval for GSK Pharma
hydrochloride with L- change in brand
arginine eq. to name from
Cefepime……1gm Pimeriv to
(USP Specifications) Pimazon :
07-09-2017
5. 078023 Pimazon Injection 16-09-2014 405 DDC R-  USFDA Approved
500mg (Renewal due: III  Maxipime 500mg
Each vial contains: 15-09-2019) 13-02-2018 Injection by M/s
Cefepime as Approval for GSK Pharma
hydrochloride with L- change in brand
arginine eq. to name from
Cefepime……500mg Pimeriv to
(USP Specifications) Pimazon :
07-09-2017
6. 078022 Lacura Injection 1gm 16-09-2014 401 DDC R-  USFDA Approved
IM (Renewal due: III  Amcef Injection of
Each vial contains: 15-09-2019) 13-02-2018 M/s Linear Pharma
Ceftriaxone as sodium Approval for
……1gm change in brand
(USP Specifications) name from
Ceftabak to
Lacura :
06-12-2017
7. 078021 Lacura Injection 16-09-2014 394 DDC R-  USFDA Approved
500mg IM (Renewal due: III  El-cef Injection of
……500mg change in brand
Ceftabak to
Lacura :
06-12-2017
8. 078020 Lacura Injection 16-09-2014 402 DDC R-  USFDA Approved
250mg IM (Renewal due: III  El-cef Injection of
Ceftabak to
Lacura :
06-12-2017
9. 078025 Kors Injection 1gm 16-09-2014 404 DDC R-  PMDA Japan
Each vial contains: (Renewal due: III Approved
Cefoperazone as 15-09-2019) 13-02-2018  2SUMby Sami
sodium ……500mg Approval for Pharma
Sulbactum as change in brand
sodium….500mg name from
(Wenovo‘s Ceatak to Kors :
Specifications) 05-10-2017
10. 078026 Kors Injection 2gm 16-09-2014 403 DDC R-  Approved in Europe
Each vial contains: (Renewal due: III (Poland, Slovakia,
Cefoperazone as 15-09-2019) 13-02-2018 Czech Republic) by
sodium ……1gm Approval for EMA
Sulbactum as change in brand  Cebac Injection
sodium….1gm name from 2gm by M/s Bosch
(Wenovo‘s Ceatak to Kors :
Specifications) 05-10-2017
11. 078066 Iboxime Dry 05-11-2014 397 DDC R-  USFDA Approved
Suspension 100mg (Renewal due: III  Cef-OD by CCL
Each 5ml after 04-11-2019) 13-02-2018
reconstitution Approval for
contains: change in brand
Cefixime as trihydrate name from
……100mg Bestcef to
(USP Specifications) Iboxime :
07-09-2017
12. 078067 Iboxime Dry 05-11-2014 396 DDC R-  USFDA Approved
Suspension 200mg (Renewal due: III  Cef-OD by CCL
Each 5ml after 04-11-2019) 13-02-2018
reconstitution Approval for
contains: change in brand
Cefixime as trihydrate name from
……200mg Bestcef to
(USP Specifications) Iboxime :
07-09-2017
13. 078068 Lacura Injection 1gm 05-11-2014 398 DDC R-  MHRA Approved
IV (Renewal due: III  3-zone of Zeb
Each vial contains: 04-11-2019) 13-02-2018
……1gm change in brand
(USP Specifications) name from BAC
to Lacura :
07-09-2017
14. 078069 Lacura Injection 05-11-2014 395 DDC R-  MHRA Approved
500mg IV (Renewal due: III  3-zone of Zeb
Each vial contains: 04-11-2019) 13-02-2018
to Lacura :
07-09-2017
15. 078070 Lacura Injection 05-11-2014 399 DDC R-  MHRA Approved
250mg IV (Renewal due: III  Rocephin by
Each vial contains: 04-11-2019) 13-02-2018 Martin Dow
to Lacura :
07-09-2017
16. 077890 Iboxime Capsule 17-06-2014 407 DDC R-  USFDA Approved
400mg (Renewal due: III  Dispel Capsules of
Each capsule contains: 16-06-2019) 13-02-2018 M/s Fynk
Cefixime as trihydrate Approval for Pharmaceuticals
(Manufacturer‘s name from
Specifications) Bestcef to
Iboxime :
07-09-2017
In support to the request the firm has provided following documents:

i) Application with prescribed fee amounting to Rs.50,000/- for each product.
ii) Initial Registration Letters and renewal status.
iii) NOC dated 02-04-2018 from M/s Wenovo Pharmaceuticals, Taxila.
iv) Latest inspection report of M/s Wenovo Pharmaceuticals, Taxila dated 19-10-2017
concluding that firm is operating at Good level of GMP compliance.
v) Section approval letter of M/s Wenovo Pharmaceuticals, Taxila.
vi) DML of M/s Walt Danzay Pharmaceuticals dated 24-04-2017 and M/s Wenovo
Pharmaceuticals dated 03-02-2014.
vii) Contract manufacturing agreement between M/s Walt Danzay Pharmaceuticals and
M/s Wenovo Pharmaceuticals.
M/s Walt Danzay Pharmaceuticals have been granted with 10 sections and no product has already
been granted in the name of M/s Walt Danzay Pharmaceuticals for contract manufacturing.
Decision: Registration Board decided as follows:

i) Cancellation of registration of above mentioned products from the name of
M/s Wenovo Pharmaceuticals, Taxila.
ii) Grant of registration of above mentioned products in name of M/s Walt
Danzay Pharmaceutical, Taxila alongwith permission for contract
manufacturing by M/s Wenovo Pharmaceuticals, Taxila.
iii) Reference will be sent to Cost & Pricing Division for MRP of the product.
Case No.23 Registration of deferred products of M/s. Welwink Pharmaceuticals,

Gujranwala.
Registration Board in 234th meeting considered the following products of M/s.
Welwink Pharmaceuticals, Gujranwala and decided as mentioned in last column below:-
Name of firm Name of drug & composition Demanded Date of Decision of
pack size submission of 234th meeting
& MRP application of Registration
Board
M/s. Welwink Artifit 50mg Capsules 30‘s 17-07-2012 Approved
Pharmaceuticals, Each capsule contains:- As per subject to
Gujranwala Diacerein……………..50mg SRO reconfirmation
of codal
formalities.
Policy of 5
products per
section and
decision of me-
too committee
shall be
followed.
-do- Mopral Capsules 20/1100mg 10‘s, 14‘s 17-07-2012 Deferred for
Each capsule contains:- As per Me-too
Omeprazole……………..20mg SRO Committee
Sodium bicarbonate…1100mg
-do- Mopral Capsules 40/1100mg 10‘s, 14‘s 17-07-2012 Deferred for
Each capsule contains:- As per Me-too
Omeprazole……………..40mg SRO Committee
Sodium bicarbonate…1100mg
The above mentioned formulations has been approved by Registration Board in 269th
(product at S. No. 1) and 267th (products at S. No. 2 & 3) meeting respectively.
The firm has submitted commitments as per 251st meeting and latest inspection report
dated 20-12-2017 concluding that firm is operating at ―Satisfactory” level of GMP compliance
for all sections except liquid injectable section for which the firm was advised to provide liquid
particle counter and TOC. The firm has also submitted differential fee of Rs.12,000/- per product
dated 03-04-2018.
The firm has requested for approval of above mentioned products as per decision of
Registration Board (269th and 267th meeting).
Decision: Registration Board approved the above products as per decision taken in its
269th meeting for product at S. No. 1 and 267th meeting for products at S. No.
2 & 3.
Case No.24 Issuance of registration letter of products approved in 228th meeting (M/s.
Ambrosia Pharmaceuticals, Islamabad).
Registration Board in its 228th meeting considered the following products of M/s
Ambrosia Pharmaceuticals, Islamabad and decided as mentioned in column IV below:
Sr. Name & Demanded Decision of 228th Availability in RRAs and

No. Composition of pack and meeting of Me-too status
Product (s) price Registration Board
I II III IV V
1. Clophenicol Capsule 100‘s Approved subject to Availability in RRAs could
500mg As per satisfactory GMP not be confirmed.
Each capsule contains: SRO inspection report.
Chloramphenicol…. Chloromycetin Forte of M/s
500mg Pfizer.
2. Rumactic Gel 20gm 20gm Approved subject to Availability in RRAs and
Each tube contains: As per satisfactory GMP Me-too status could not be
Flurbiprofen……0.5% SRO inspection report. confirmed.
The firm has requested for issuance of registration letter but the availability in RRAs could
not be confirmed. The firm has not submitted differential fee.
Decision: Registration Board deferred above products for:

i) Submission of differential fee of Rs.12,000/- per product.
ii) Evidence of approval of above products by reference regulatory
authorities and evidence of me-too status for product at S. No. 2.
Case No.25 Change in Specifications

a) M/s Bio-Labs Pharmaceuticals, Islamabad have requested for change in finished
product specifications and composition of their following registered products as per details
below:-
S.No. Reg.No. Name of Drug(s) & Composition Desired Change in label claim &
on Initial Registration Letter Specifications
1. 069910 Pinaz Tablets 5mg Pinaz Tablets 5mg
Each tablet contains: Each tablet contains:
Olanzapine as citrate …..5mg Olanzapine …..5mg
(Bio-Lab‘s Specifications) (USP Specifications)
2. 069911 Pinaz Tablets 10mg Pinaz Tablets 10mg
Olanzapine as citrate …..10mg Olanzapine …..10mg
(Bio-Lab‘s Specifications) (USP Specifications)
The details of requirement as per SOPs and the documents submitted by the firm are as under:-
Requirement as per SOPs Documents submitted by the Firm.
Application with required fee as per relevant
Fee of Rs.5000/- for each product has been
SRO. If error is on part of firm. deposited.
Copy of registration letter and renewal status.
Initial Registration: 13-04-2011
Renewal due: 12-04-2016
Renewal Applied: 04-04-2016
NOC for CRF clearance. Copy of CRF (valid up to 31-12-2017)
Documents in support of proposed correction Copy of USP monograph and PIL of MHRA
approved product.
Now, the firm has requested for change in finished product specifications of products
mentioned above form Bio-Labs Specifications to ―USP Specifications‖.

i) Approved the change in finished product specifications of above products
from Bio-Lab’s Specifications to USP Specifications.
ii) Approved the correction in composition from Olanzapine as citrate to
“Olanzapine”.
b) M/s Goodman Laboratories, Islamabad have requested for change in finished product
specifications of their following registered products as per details below:-
S.No. Reg.No. Name of Drug(s) & Composition Desired Change in label claim &
on Initial Registration Letter Specifications
1. 052533 Loxigood 7.5mg Tablets Loxigood 7.5mg Tablets
Meloxicam …..7.5mg Meloxicam …..7.5mg
(BP Specifications) (USP Specifications)
2. 052541 Loxigood 15mg Tablets Loxigood 15mg Tablets
Meloxicam …..15mg Meloxicam …..15mg
(BP Specifications) (USP Specifications)
The details of requirement as per SOPs and the documents submitted by the firm are as under:-
Requirement as per SOPs Documents submitted by the Firm.
Application with required fee as per relevant Fee of Rs.5000/- for each product has been
SRO. If error is on part of firm. deposited.
Copy of registration letter and renewal status. Initial Registration: 23-09-2008
Renewal due: 22-09-2013
Renewal Applied: 30-11-2017 (Rs.30,000 per
product vide SRO 1005(I)/2017) Registration
Board acceded to the request of the firm for
grant of renewal in its 277th meeting.
NOC for CRF clearance. Copy of CRF (valid up to 31-12-2018)
Documents in support of proposed correction Copy of USP monograph.
Now, the firm has requested for change in finished product specifications of products
mentioned above form BP Specifications to ―USP Specifications‖.
Decision: Registration Board approved the change in finished product specifications of
above products from BP Specifications to USP Specifications.
Case No.26 Registration for export purpose only:

a) M/s. Davis Pharmaceuticals, Islamabad have requested for grant of registration of
following drug for export purpose only. The details are as under:-
S. Name of drug(s) & Fee 1)International Remarks

No. Composition R&I date Availability / Me-
Form Type Too status
SOP 2) GMP/Inspection
Documents/DML, Report
CRF 3)Source of Pellets
4) Undertakings
exclusively for
export purpose
5) Undertaking
Brand Name.
1. KoF Relief Syrup 1) Fee International Not approved by any
Each 5ml contains: Rs.50,000/- (04- availability and RRAs nor already
Chlorpheniramine maleate 04-2018) me-too status not registered by DRAP.
……2.2mg 2) Form 5 provided.
Ammonium 3) NOC for CRF Evidence of
chloride…110mg clearance valid till GMP inspection registration of
Sodium citrate …. 40mg 31-12-2017. dated 09-06-2017 product in importing
Menthol……1.1mg concluding that country (Zambia) is
Green banana Liquid Syrup GMP compliance provided by the firm.
flavor…..2.4ml general section status was good. Koflyn Syrup
confirmed. (Raspberry flavour)
Undertaking of M/s Beta
regarding export healthcare
purpose on stamp Registration No.
paper is provided. (Zambia)
ZAM.PROD.LIC.
NO.134/001
2. Cold and flu relief syrup 1) Fee Reltus C&F of
Each syrup contains: Rs.20,000/- M/s. Pharmatec
Chloropheniramine (Page 500-501/C) Pharma, Karachi
maleate………..1mg/5ml
Paracetamol.…..80mg/5ml 2) Form 5 GMP inspection
Pseudoephedrine (HCl) Page 505-554/C dated 09-06-2017
…….15mg/5ml concluding that
3) NOC for CRF GMP compliance
31-12-2017 status was good.
Liquid Syrup Undertaking
general section regarding export
confirmed. purpose on stamp
paper is provided.

i) Approved the product at S. No 2 for export registration.
ii) Deferred the product at S. No. 1 for evidence of approval in importing
country.
b) M/s. Warafana Pharmaceuticals, Islamabad have requested for grant of registration

of following drug for export purpose only. The details are as under:-
S. Name of drug(s) & Fee 1)International Remarks

No. Composition R&I date Availability / Me-
Form Type Too status
SOP 2) GMP/Inspection
Documents/DML, Report
CRF 3)Source of Pellets
4) Undertakings
exclusively for
export purpose
5) Undertaking
Brand Name.
1. Wanadol –CF tablet 1) Fee Panadol-CF M/s.
Each tablet contains: Rs.20,000/- GSK Pharma,
Paracetamol ……..500mg (Page 101-102/C) Karachi
Chlorpheniramine (Page 214/C)
maleate………..4mg 2) Form 5
Pseudoephedrine Page 105-120/C GMP inspection
hydrochloride……….60mg dated on 12-07-
3) NOC for CRF 2017 concluding
31-12-2017 that firm is
(Page 208/C) operating at fair
level of
Tablet General compliance with
section GMP.
(Page 149/C) (Page 210-212/C)
Undertaking
regarding export
purpose
(Page 146-147/C)
Decision: Registration Board approved the above product for export registration.
Case No. 27 Grant of Registration:
Registration Board in its 254th, 276th, 277th and then in 279th meeting considered the case
wherein M/s Alza Pharmaceuticals, Rawalpindi have applied for transfer of following products
from Al-Shifa Pharmaceuticals Rawalpindi (Old) premises to New premises at M/s Alza
Pharmaceuticals, Al-Shifa Trust Eye Hospital, Jhelum Road, Rawalpindi:-
S. Name of Reg.No. Brand Name / Label Claim Pack Price Date of Status in
N the Firm. Size Submissi reference
o on regulatory
agencies
1. M/s Alza 019888 Zyline 0.40/1.0% Eye Drops 10ml De- 07-08- Couldn‘t
Pharmaceut Each ml contains:- control 2015 be
icals, Zinc Sulphate…….4mg led Dy.No.16 verified.
Al-Shifa Boric Acid……….10mg 72
Trust Eye (As per Innovator‘s Specs.) Rs.20,000
Hospital, (Astringent) /-
Jhelum
Road,
Rawalpindi
2. -do- 019889 Demasone Eye Drops 5ml As Per 07-08- USFDA
Each ml contains:- SRO 2015 approved
Dexamethasone Sodium 471(I)/ Dy.No.16
Phosphate 1.093mg eq. to 93 49
Dexamethasone Rs.20,000
Phosphate……..……….1mg /-
(USP Specs.)
(Corticosteroid)
3. -do- 019890 Demasone-N Eye Drops 5ml De- 07-08- Discontinu
Each ml contains:- control 2015 ed in
Dexamethasone Sodium led Dy.No.16 USFDA &
Phosphate 1.093mg eq. to 66 not found
Dexamethasone Rs.20,000 approved
Phosphate…..1mg /- by UK.
Neomycin Sulphate eq. to
Neomycin
Base……………....3.5mg
(USP Specs.)
(Corticosteroid and antibiotic)
4. -do- 019891 Tearsol Eye Drops 10ml De- 07-08- Approved
Each ml contains:- 15ml control 2015 in UK-
Dextran 70…….……1mg led Dy.No.16 MHRA as
Hydroxypropyl 63 Dextran
Methylcellulose….`….0.4% Rs.20,000 70… 1mg
(USP Specs.) /- and
(Eye Lubricant) Hydroxypr
opyl
methylcell
ulose…3m
g/ml
(0.3%).
The firm
has now
requested
for change
in
compositio
n as per
RRAs.
5. -do- 019892 Gentabiotic 0.3% Eye Drops 5ml As Per 07-08- Discontinu
Each ml contains:- SRO 2015 ed in
Gentamycin Sulphate 471(I)/ Dy.No.16 USFDA
BP…3mg 93 41 *Federal
(USP Specs.) Rs.20,000 Register
(Aminoglycoside Antibiotic) /- determinat
ion that
product
was not
discontinu
ed or
withdrawn
for safety
or efficacy
reasons*
6. -do- 019893 Cromolergic 4% Eye Drops 5ml As Per 07-08- USFDA
Each ml contains:- SRO 2015 approved
Cromoglycate Sodium 471(I)/ Dy.No.16
BP…40mg 93 39
(BP Specs.) Rs.20,000
(Non-steroidal anti- /-
inflammatory drugs (NSAIDs)
7. -do- 019894 Cromolergic 2% Eye Drops 5ml De- 07-08- UK-
Each ml contains:- control 2015 MHRA
Cromoglycate Sodium led Dy.No.16 approved
BP…20mg 54
(BP Specs.) Rs.20,000
(Non-steroidal anti- /-
inflammatory drugs (NSAIDs)
8. -do- 019895 Tromid Eye Drops 1% 10ml De- 07-08- USFDA
Each ml contains:- control 2015 approved
Tropicamide……….10mg led Dy.No.16
(USP Specs.) 61
(Anticholinergic) Rs.20,000
/-
9. -do- 019897 Predsol 1% Ophthalmic 5ml As Per 07-08- USFDA
Suspension SRO 2015 approved
each ml contains:- 471(I)/ Dy.No.16
Prednisolone acetate…..10mg 93 57
(USP Specs.) Rs.20,000
(corticosteroid) /-
10. -do- 025683 Naphstine 0.025/0.3% Eye 10ml Rs.20. 07-08- USFDA
Drops 15ml 00 2015 approved
Each ml contains:- Rs.36. Dy.No.16 (as OTC
Naphazoline (as 00 67 drug)
hydrochloride)……0.25mg Rs.20,000
Pheniramine (as maleate).3mg /-
(USP Specs.)
(Decongestant and
Antihistamine)
11. -do- 025684 Balanced Salt Solution 500 Rs.250 07-08- USFDA
Each ml contains:- ml .00 2015 approved
Sodium Chloride.…….6.4mg Dy.No.16
Potassium Chloride…0.75mg 69
Calcium Chloride.….0.48mg Rs.20,000
Magnesium Chloride...0.3mg /-
Sodium Acetate..….3.9mg
Sodium citrate….…1.7mg
(Isotonic solution)
12. -do- 025685 Atropin 1% Eye Drops 10ml Rs.12. 07-08- USFDA
Each ml contains:- 15ml 00 2015 approved
Atropine Sulphate….10mg Rs.17. Dy.No.16
(USP Specs.) 00 42
(Mydriatics, Cycloplegics) Rs.20,000
/-
13. -do- 025686 Alklorafen 0.5/0.4% Eye 10ml Rs.19. 07-08- Not found
Drops 15ml 00 2015 in USFDA
Each ml contains:- Rs.35. Dy.No.16 & UK-
Chloramphenicol Base…5mg 00 46 MHRA
Hydroxypropylmethylcellulose Rs.20,000
………………..4mg /-
(USP Specs.)
(Antibiotic)
14. -do- 025687 Askaine 0.5% Eye Drops 10ml Rs.30. 07-08- USFDA
Ceach ml contains:- 15ml 00 2015 approved
Proparacaine hydrochloride Rs.42. Dy.No.16
….5mg 00 48
(Local Anesthetic) /-
15. -do- 025688 Pilostat 2% Eye Drops 10ml Rs.40. 07-08- USFDA
Each ml contains:- 00 2015 approved
Pilocarpine Dy.No.16
hydrochloride.…20mg 58
(Antiglaucoma Drugs) /-
16. -do- 025689 Methocel Eye Drops 2.25 Rs.500 07-08- Not found
Each ml contains:- ml .00 2015 in USFDA
Hydroxypropylmethylcellulose Dy.No.16 & UK-
…20mg 73 MHRA
Sodium Chloride…...…6.4mg Rs.20,000
Potassium Chloride.…0.75mg /-
Calcium Chloride……0.48mg
Magnesium Chloride…0.3mg
Sodium Acetate……3.9mg
Sodium Citrate…….1.7mg
(Alza‘s Specs.)
(Visocoelastic Gel)
17. -do- 025690 Al-amide 10% Eye Drops 10ml Rs.9.5 07-08- USFDA
Sulphacetamide Dy.No.16
Sodium…….100mg 59
(Sulfonamide Antibiotic) /-
18. -do- 025691 Al-amide 20% Eye Drops 10ml Rs.10. 07-08- Not found
Each ml contains:- 00 2015 in USFDA
Sulphacetamide Dy.No.16 & UK-
Sodium…….200mg 50 MHRA
(Sulfonamide Antibiotic) /-
19. -do- 025692 Tobralux 0.3% Eye Drops 5ml Rs.60. 07-08- USFDA
Tobramycin……….3mg Dy.No.16
(USP Specs.) 60
(Aminoglycoside Antibiotic) Rs.20,000
/-
20. -do- 031204 Shifopin 0.03% Eye Drops 5ml Rs.80. 07-08- USFDA
Flurbiprofen Dy.No.16
Sodium……0.3mg 47
(Nonsteroidl Anti- /-
inflammatory)
21. -do- 031206 Cyclocil 1.0% Eye Drops 10ml Rs.90. 07-08- USFDA
Cyclopentolate Dy.No.16
HCl……….10mg 55
(Cycloplegic) /-
22. -do- 031207 Al-Fenac 0.1% Eye Drops 5ml Rs.80. 07-08- UK-
Each ml contains:- 00 2015 MHRA
Diclofenac Sodium………1mg Dy.No. approved
(NSAIDs) 1643
Rs.20,000
/-
23. -do- 031208 Flobacin 0.3% Eye Drops 5ml Rs.80. 07-08- USFDA
Ofloxacin………..3mg Dy.No.16
(USP Specs.) 77
(Fluroquinolone Antibiotic) Rs.20,000
/-
24. -do- 031209 Tetrachrom Eye Drops 10ml Rs.110 07-08- Not found
Each ml contains:- .00 2015 in USFDA
Sodium Cromoglycate Dy.No.16 & UK-
BP……40mg 62 MHRA
Tetrahydrozoline HCl Rs.20,000
USP….0.5mg /-
(Anti-Allergics)
25. -do- 031210 Shifol 0.5% Eye Drops 5ml Rs.80. 07-08- UK-
Each ml contains:- 00 2015 MHRA
Timolol ………5mg as timolol Dy.No.16 approved
Maleate………….6.8mg 40
(Anti-Glucoma Agent) /-
26. -do- 049229 Shifsone 0.5/0.1% Eye Drops 5ml Rs.20. 07-08- Not found
Each ml contains:- 00 2015 in USFDA
Chloramphenicol……… 5mg Dy.No.16 & UK-
Dexamethasone as Sodium 52 MHRA
Phosphate………….…..1mg Rs.20,000
(Alza‘s Specs.) /-
(Corticosteroid and Antibiotic)
27. -do- 049230 Shifeye 0.3/0.1% Eye Drops 5ml Rs.102 07-08- USFDA
Tobramycin.…..…3mg .00 2015 approved
Dexamethasone (as Dy.No.16
Phosphate)...1mg 75
(Corticosteroid + Antibiotic) /-
28. -do- 026389 Alciprox 0.3% Eye Drops 5ml Rs.90. 07-08- USFDA
Ciprofloxacin HCl Dy.No.16
Monohydrate 0.35% eq. to 56
ciprofloxacin Base Rs.20,000
………….……0.3% /-
(USP Specs.)
(Quinolone Antibiotic)
Decision of 254th meeting of Registration Board:
 Cancellation of registrations of above products except at S.No. 3,13,18,24 and 26 from

M/s Al-Shifa Pharmaceuticals Rawalpindi.
 Registration of above products except at S.No. 3,13,18, 24 and 26 in the name of M/s Alza
Pharmaceuticals, Al-Shifa Trust Eye Hospital, Jhelum Road, Rawalpindi. The Registration
Board authorized its Chairman for issuance of registration letters after MRP fixation by
Cost & Pricing Division.
 Products at S. No. 3, 13, 18, 24 and 26 were deferred for confirmation of approval status
by the reference drug regulatory authorities.
The renewal status of above products could not be verified from the RRR section due to which
the letter for transfer of registration in the name of M/s Alza Pharmaceuticals, Al-Shifa Trust Eye
Hospital, Jhelum Road, Rawalpindi could not be issued.
Now the firm has requested to consider these applications for new/fresh registration and
adjust the submitted fee of Rs.20,000/- for each product as fee of registration of drugs. The
applications have been evaluated as per checklist of 251st meeting of Registration Board. Firm has
also provided the latest GMP inspection report dated 07-07-2017 concluding that panel
unanimously recommended for grant of GMP certificate.

Registration Board deferred the request of M/s Alza Pharmaceuticals, Rawalpindi for
further deliberation.
The case was then again considered in 277th meeting of Registration Board and the Board decided
as follows:
Registration Board deferred the request of M/s Alza Pharmaceuticals, Rawalpindi for
opinion on legal position from Legal Affairs Division, DRAP for consideration of above
applications whose fee has been submitted under head of “miscellaneous” account.
The case was referred to LA Division for their opinion regarding fee. LA Division
forwarded the case to B & A Division. B & A Division replied as follows:
“Refer 8th Authority meeting dated 02-05-2013 Agenda no. II, as per decision transfer of
registration fee may be adjusted against fresh registration fee on recommendations of
concerned Division.”
The decision of said Authority meeting is reproduced below:
―After deliberation the Authority noted that under the rules fee once deposited was not refundable.
However, in these cases the money so deposited by the applicants was in excess of the due fee,
which had been deposited by mistake or under wrong impression and the refund or adjustment of
this extra amount against any fresh applications was not barred by the rules. The Authority agreed
not to refund but to adjust this extra amount against fresh applications. It was further decided that
in future such kind of applications shall be processed by the concerned Division and Director B &
A shall be authorized to approve them on case to case bases.‖
Registration Board deferred the request of the firm for further deliberation and discussion with
LA Division.
Decision: Registration Board deliberated and decided that the case of fee adjustment
will be dealt by PER Division and recommendations will be sent to B & A
Division.
Registration-IV
Case No.28 Change In Specification/Formulation of Registered Products of M/s. Aries
Pharmaceutical (Pvt) Ltd, Peshawar.
M/s Aries Pharmaceuticals (Pvt.) Ltd, Peshawar has applied for change in
specifications/formulation of some of their already registered products as per following details:
Name of Drug(s) with Name of Drug(s) with Remarks
Sr. Reg.
Existing Formulation & Proposed Formulation &
No. No.
Specifications Specifications
1 Olanpia 5mg Tablets Olanpia 5mg Tablets USP Monograph is
Each tablet contains:- Each tablet contains:- available for
Olanzapine (as Citrate) Olanzapine..........……..5mg olanzapine tablet.
060024 …...5mg (USP Specifications) Standard formulation
(Aries Specification) approved by RRA
(MHRA) is film
coated.
2 Olanpia 10mg Tablets Olanpia 10mg Tablets -do-
060025
Olanzapine (as Olanzapine....................10mg
Citrate).…..10mg (USP Specifications)
(Aries Specification)
3 Mebofac Tablets 135mg Mebofac Tablets 135mg Standard formulation
Each film coated tablet Each film coated tablet approved by RRA
contains:- contains:- (MHRA) contains
084267 Mebeverine Mebeverine HCl Mebeverine HCl
………135mg ………135mg ………135mg.
(BP Specifications) (BP Specifications)
The firm has submitted following documents.

i. Fee Deposit slips Rs. 5,000 for each product
ii. Copy of the registration letters and renewal status (valid).
iii. Reference Material from relevant pharmacopeias.
iv. Copy of NOC for CRF (valid upto 31-12-2017).
The Board was also informed that on further scrutiny the olanzapine tablet was found
approved in both film coated and uncoated forms by Reference Regulatory Authority (UK
MHRA)
Decision: - Registration board decided as under: -
i. For product at S.No.1 and 2, approved the change in specifications from

“Aries Specification” to “USP Specification” along with change in
formulation from “Oanzapine (as Citrate)” to “Olanzapine”, in
accordance with the standard formulation approved by Reference
ii. For product at S.no.3, approved the correction of formulation to film
coated tablet containing “Mebeverine HCl….5mg” in accordance with the
standard formulation approved by Reference Regulatory Authorities.
Case No.29 Cancellation of Registration of Ciprofoz Dry Suspension 125mg

of M/s Fozan Pharmaceuticals Industries, Hattar.
In the light of decision taken by the Board in its 250th meeting, M/s. Fozan
Pharmaceuticals (Pvt,) Ltd, was issued a show cause notice regarding cancellation of
registration of Ciprofloxacin 125mg Dry Suspension as the formulation was not approved by
Reference Regulatory Authorities. Now the firm has referred to the decision taken by the
Registration Board in its 269th Meeting, regarding review of formulation of Ciprofloxacin
125mg/5ml Dry Suspension i.e reproduced below and further requested for issuance of letter:
i. Keeping in view the following statement written in Qualitative and quantitative

composition “2.5 mL suspension after reconstitution (1/2 measuring spoon)
contains 125 mg ciprofloxacin” and domestic conditions for difficulties in
dispensing 250mg/5ml suspension for children under 2 years of age, Registration
Board decided to approve the formulation of ciprofloxacin 125mg/5ml granules
and solvent for oral suspension as per reference product approved by USFDA
and MHRA.
ii. Registration Board was apprised that already registered products were either not
providing diluent with the ciprofloxacin suspension or the composition of diluent
was not as per the reference product. Registration Board advised Pharmaceutical
Evaluation Cell to prepare the case along with details including manufacturing
area requirements of the solvent/diluent and considering the legal requirements for
the separate registration of the solvent for further deliberation in Registration
Board.
Detail of Ciprofloxacin 125mg Dry Suspension registration granted to the firm is as

under:
Sr. Reg. Name of Drug(s) with Remarks
No. No. formulation
1. 064462 Ciprofoz Dry Suspension 125mg Reg. letter dated 22-10-2010
Each 5ml contains:- Renewal applied on 22-10-2015.
Ciprofloxacin (as HCl)…125mg Formulation is non- pharmacopeial,
(USP Specification ) product specifications need to be
corrected in accordance with the decisions
of M-264 & M-266 of Registration Board.
Decision: - Registration Board deferred the case for confirmation of renewal status from
RRR Section.
Case No.30 Approval Granted For Registration of Tizanidine 6mg Capsule
Following products of various firms have been approved by the Registration Board as per
details mentioned below:-
Approved Remarks
Sr. Name of Drug(s) with
Name of Firm in RB
No. formulation
Meeting
1. M/s. Weather Tizadine 6mg Capsule 263rd
Folds Each capsule contains:- Meeting
Pharmaceuticals, Tizanidine….. 6mg Me-Too status
Hattar (Muscle relaxants) couldn‘t be
Mfg Specs. verified.
2. M/s. Wnsfield T-Dine 6mg Capsules 264th
Pharmaceuticals, Each capsule contains:- Meeting
Hattar Tizanidine………6mg
(Muscle relaxant)
Manuf. Specs
3. M/s. Welmark T-Mark 6mg Capsules 264th
Pahrmaceuticals Each capsule contains:- Meeting
Hattar Tizanidine………..6mg
(Muscle relaxant)
Manuf.Specs
As per available record, the formulations already approved for Tizanidine 6mg Capsule
are sustained release. However, the above formulations are not sustained release as evident from
form-5.
Decision: - Registration Board decided that the firms shall be directed to apply on Form-
5D with fresh fee of Rs.50,000/-each, along with stability data and requisite
documents/ information.
Case No.31 Deferred Products of M/s Rakaposhi Pharamceuticals, Peshawar

Following products of M/s Rakaposhi Pharamceuticals, Peshawar were deferred in 271st
meeting of Registration Board for confirmation of approval status in Reference Regulatory
Authorities.
S# Product Name and previous Regn. Fee Remarks
No, Deposit slip
No. &
Date
1. Capsule Minaravit Rs:10000/- Balance fee of Rs.10000/- needs to
Each capsule contains:- 0583884 be submitted.
VitaminA……10000IU 12-06-17 Formulation as per previous reg.
(powder form) letter:
Vitamin D…..1000IU Capsule Minaravit
Vitamin E……0.5IU Each capsule contains:-
Vitamin B1…….10mg VitaminA……10000IU
Vitamin B2……..10mg (powder form)
Vitamin B12……5mcg Vitamin D…..1000IU
Nitocinamide….100mg Vitamin E……0.5IU
Calcium pantothenate……5mg Vitamin B1…….10mg
Iron (as sulphate).10mg Vitamin B2……..10mg
Calcium ……….50mg Vitamin B6….2mg
Iodide……….0.15mg Vitamin B12……5mcg
Maganese……..1mg Nitocinamide….100mg
Copper…………1mg Calcium pantothenate……5mg
Magnesium……5mg Iron (as sulphate).10mg
Zinc………….1.2mg Calcium ……….50mg
Molybedenium..0.5mg Iodine……….0.15mg
(Rakaposhi Spec) Vitamin C……150mg
Reg.No.020336 Maganese……..1mg
Copper…………1mg
Magnesium……5mg
Zinc………….1.2mg
Molybedenium….0.2mg
Magnesium Stearate….10mg
Me-too status couldn’t be verified

2. In-vit Syrup Rs.20000/- Formulation as per previous
Each 100ml contains:- 0583877 registration letter:
Ferrocholinate ………1000mg 12-6-2017 In-vit Syrup
L-Lysine HCl ………500mg Each 100ml contains:-
Vitamin B6 ……40mg Ferrocholinte ………1000mg
Vitamin B12 ……200mcg L-Lysine HCl ………500mg
Nicotanamide …….200mg Vitamin B6 ……40mg
D-Panthenol…..66.07mg Vitamin B12 ……200mcg
Inositol ……..500mg Nicotanamide …….300mg
Amino ethyl sulfonic acid….2000mg D-Panthenol…..66.07mg
Folic Acid ……22mg Inositol ……..500mg
(Vitamins and Iron) Amino ethyl sulfonic acid….2000mg
Regn. N0.036747 Folic Acid ……2.22mg
Me-too status couldn’t be verified

3. Tablet Becevit - Fee of Rs.20000/- needs to be
Each tablet contains:- submitted as the firm previously
Vitamin B1….15mg requested for adjustment of renewal
Vitamin B2….15mg fee i.e Rs.10000/- submitted for this
Vitamin B6….10mg product and Rs.10000/- submitted
Calcium pantothenate……25mg for Syp Remelton as fresh fee for
Niacinamide…100mg registration of this product.
Vitamin C……500mg However, the request was regretted
Vitamin B12…10mcg by B & A Division.
Folic Acid……..1mg
(BP Specification) Me-too status couldn’t be verified
Reg.No.043441
4. Syrup Rib- C 120ml Rs:10000/- Balance fee of Rs.10000/- needs to
Each 5ml contains:- 0716780 be submitted.
Vitamin B1 …4.16mg 12-06-2017 Me-too status couldn’t be verified
Vitamin B2…1.66mg
Vitamin B6 …1mg
Vitamin B12 …8.33mg
Lysine Mono HCl …....33.33mg
Cal. D pantothenate ……..2.5mg
Inositol ……5mg
Vitamin C …….75mg
Nicotinamide…18mg
Reg.No.036746
5. Vifolix Cap Rs.10,000/ Balance fee of Rs.10000/- needs to
Each capsule contains:- 0322512 be submitted.
Folic Acid……..2mg Dated 10- Me-too status couldn’t be verified
Ferrous Fumarate……100mg 08-2015
Vitamin B1…..10mg
Vitamin B2…..10mg
Vitamin B6…..10mg
Vitamin C…..250mg
Nicotinamide…..10mg
Reg.No.032583
6. Syrup Becevit 120ml Rs:10000/- Balance fee of Rs.10000/- needs to

Each 5ml contains:- 0715951 be submitted.
Vitamin B1….10mg 12-06-17 Me-too status couldn’t be verified
Vitamin B2….10mg
Vitamin B6….10mg
Lysine Mono HCl..............20mg
Calcium pantothenate……3mg
Niacinamide……50mg
Vitamin C….150mg
Vitamin B12……5mcg
(BP Specification)
Reg.No. 043442
Decision: - Registration board decided as under: -
i. Deferred the product at S.No.1 and 2 for submission of revised

formulations as per previous registration letters along with fresh fee of
Rs.20,000/-each.
ii. Deferred the product at S.No.3 for submission of fresh fee of Rs.20,000/-
and products at S.No.4-6 for submission of fresh fee of Rs.10,000/-each as
the request for adjustment of previously submitted renewal fee of the
aforementioned products, has already been regretted by B & A Division of
DRAP.
Case No.32 Deferred Products of M/s Delta Pharama (Pvt) Ltd, Risalpur.
Following Products of M/s Delta Pharma, Risalpur were deferred in M-278 meeting of
Registration Board for submission of evidence of approval status by Reference Regulatory
Authorities/ me- too status. Details are as under:
S# Brand Name, Composition Dy.No./Date & Evidence of Section Remarks
and (Reg.No) Demanded Availability in Approval, Last
Price/ Pack RRAs and Me-too Inspection
Status Provided Report & DML
by Firm
Section approval
1. Ketry 200mg Tablet Dy.No.100 SRA status not Deferred in M-278
18-12-2017
Each film coated tablet 23-01-18 provided Last inspection in the light of
contains: - 20,000/- report decision of 244th
Ketoconazole….200mg 22-01-2018 Nizoral by M/s. 15-08-2017
DML 18-12-2017
meeting of Reg.
(USP Specifications) Rs.25/1‘s Janssen- Cilag Bd. Regarding
Rs.250/10‘s issuance of show
cause notices to
registered oral
ketoconazole
products for de-
registration of
product due to
safety concerns.
2. Faxetine 20mg Tablet Dy.No.96 SRA status not -do- Austria approved
Each film coated tablet 23-01-18 provided Mutan 20 mg -
contains: 20,000/- film-coated
Fluoxetine as 22-01-2018 Floxac by M/s. tablets by G. L.
HCl…..20mg Rs.150/20‘s Shazoo Pharma. Pharma GmbH.
3. Delmol CF tablet Dy.No.102 TGA approved. -do- Formulation as per
Each tablet contains: - 23-01-18 Cipla Cold and previous reg.
Paracetamol…500mg 20,000/- Flu night by Cipla Letter:
Pseudoephedrine…60mg 22-01-2018 Australia Each tablet
Chlorpheniramine…4mg Rs.3/1‘s contains
(Manufacturer's Rs.300/ 100‘s Panadol CF by Paracetamol…500
Specifications) M/s. GSK mg
Pseudoephedrine
HCl…..60mg
Chlorpheniramine
Maleate…4mg
Formulation is
available in USP.
Provided SRA
reference is not
compliant.
4. Delvitis Tablet Dy.No.95 TGA approved. -do- Composition as
Each film coated tablet 23-01-18 Vitamins for kids per previous
contains: - 20,000/- sports by M/s. registration letter:
Vitamin A……..5000IU 22-01-2018 Orien Vitamin
Vitamin D……..400IU Laboratories A…..5000IU
Vitamin C….75mg Rs.5/1‘s Australia Vitamin
Vitamin B1….2mg Rs.150/30‘s D3……..400IU
Vitamin B2….5mg Surbex T by M/s. Vitamin C….75mg
Vitamin B6…2mg Abbott Karachi. Vitamin
Vitamin B12….2mcg B1….10mg
Calcium d Pentothenate Vitamin
…5mg B2….10mg
Folic Acid…0.25mg Vitamin B6…5mg
Nicotinamide…20mg Vitamin
Vitamin E….10mg B12….3mcg
(Manufacturer's Vitamin E…10mg
Specifications) Calcium d
Pentothenate
…10mg
Folic Acid…5mg
Nicotinamide…20
mg
Me-too status
couldn’t be
verified
5. Nymph Tablets Dy.No.93 TGA approved. -do- Me-too status
Each film coated tablet 23-01-18 Vitamins for kids couldn’t be
contains: - 20,000/- sports by M/s. verified
Vitamin A……..5000IU 22-01-2018 Orien
Vitamin D……..400IU Laboratories
Vitamin C….75mg Rs.4.16/1‘s Australia
Vitamin B1….2mg Rs.125/30‘s
Vitamin B2….5mg Surbex T by M/s.
Vitamin B6…2mg Abbott Karachi.
Vitamin B12….2mcg
Calcium d Pentothenate
…….5mg
Folic Acid………0.25mg
Nicotinamide……20mg
(Manufacturer's
Specifications)
Decision: - Registration Board decided as under: -
i. Deferred the product at S.No.1 in the light of decisions taken by the

Registration Board vide its 244th meeting.
ii. Deferred the product at S.No. 3 for confirmation of availability in
iii. Approved the product at S.No. 2 and 5.
iv. Approved the product at S.No. 4 with previously registered formulation as
mentioned in the last column.
Case No.33 Request of M/s Delta Pharma, Risalpur for Extension in Contract
Manufacturing Permission Along With Change in Contract Manufacturer.
M/s Delta Pharma, Risalpur has submitted 3 times renewal fee on 04-12-2017 in
pursuance of SRO 1005(I)/ 2017 dated 05-10-2017 for renewal/ extension in contract
manufacturing permission along with change in contract manufacturer of following products:
S.No Reg.No Name of Product Previous New Date of

Manufacturer Manufacturer applications/Fe
e
1. 050327 G-Xon 500mg M/s. Medicraft M/s Bio-Lab 04-12-2017
Injection Pharmaceutical (Pvt) Ltd., Rs.150,000/-
Each vial contains: s, Peshawar Islamabad
Ceftriaxone (as
Sodium)….500mg
(USP Specification)
2. 044259 G-Xon 250mg -do- -do- -do-
Injection
Each vial contains:
Ceftriaxone (as
Sodium)….250mg
(USP Specification)
3. 044260 G-Xon 1gm -do- -do- -do-
Injection
Each vial contains:
Ceftriaxone (as
Sodium)….1gm
(USP Specification)
With reference to above mentioned case following facts are submitted:
i. The 3 times renewal fee in respect of above products was submitted even after
expiry of deadline i.e 03-12-2017 set under the SRO 1005(I)/ 2017.
ii. The 3 times renewal fee has been submitted on 4-12-2017 while the DML status
was invalid. However the firm was granted DLM (Afresh) on 18-12-2017 with
Tablet (General) & Capsule (General) sections.
The Board was informed that the fee has been submitted under the head of contract
manufacturing. However the firm, in its request has stated that the fee is submitted with reference
to SRO 1005(I)/ 2017.
Decision: - Registration Board observed that though the fee is submitted under SRO
1005(I)/ 2017 which address the issue of renewal of registration while this case
falls in the category of extension of contract manufacturing. However, since
the fee is submitted during the period when the DML of the firm was invalid
so the case was deferred for soliciting the views/ comments of Legal Affairs
Division of DRAP regarding validity of the fee submitted by the firm.
Case No.34 Registration Granted to M/s Wellborne Pharmachem & Biologicals
M/s Wellborne Pharmachem & Biologicals has been granted registration of same
formulation vide 276th and 277th meetings of Registration Board as per following details:
S.No. Brand name and Detail of Decision Reference of Remarks

Composition submissions/ Reg. Board
Dy.No. meeting
1 M-Vglip 50/850mg tablet Form 5 Approved with M-276 Registration
Each film coated tablet Dy. No.3894; 03- Innovator‘s letter issued on
contains: 10-2016; specifications. 30-03-2018
Vildagliptin…....50mg Rs.20,000/- (03- with Brand
Metformin 10-2016) Name Dagmet
hydrochloride…...850mg 14‟s and 28‟s / As (Reg. No.
per drug pricing 088671)
policy 2015
2 M-Vglip 50/850mg tablet Form 5 Approved with M-277 Registration
Each film coated tablet Dy. No.3894; 03- innovator‘s letter issued on
contains: 10-2016; specification 22-03-2018
Vildagliptin……....50mg Rs.20,000/- (03- and shelf ife of with Brand
Metformin 10-2016) 18 months. Name Dagmet
hydrochloride…...850mg 14‟s and 28‟s / As (Reg.
per drug pricing No.088557)
policy 2015
Decision: - Registration Board decided to consider the approval of above mentioned

product in 277th meeting as redundant as the firm has already been granted
the registration of same product in 276th Meeting of Registration Board.
Consequently, the registration letter No.F.13-13/2017-Reg-IV (M-277) dated
22-03-2018, conveying registration of Dagmet 50/850mg Tablet
(Reg.No.088557) with reference to 277th Registration Board’s meeting shall,
therefore, stands null and void.
Case No.35 Correction in Specifications of Registered products
Following firms had applied for change of brand name of their various products. During
evaluation it was noted that corrections are required in specification of these products. The details
are as under:
S. Name of Regn. Brand Name with Composition & Brand Name with Composition &
# Firm No. existing Specifications Correct Specification
1. M/s 046793 Aglop Capsule Aglop Capsule
WnsFeild, Each capsule contains:- Each capsule contains:-
Hattar Cefixime trihydrate eq.to Cefixime trihydrate eq.to
Cefixime……400 mg Cefixime……400 mg
(USP Specification) (JP Specification)
2. -do- 051151 Altercast Tablets Altercast Tablets
Each film coated tablet contains:- Each film coated tablet contains:-
Montelukast as Sodium…..10mg. Montelukast as Sodium…..10mg.
(Wnsfeild Specification) (USP Specification)
3. -do- 056741 Altercast 5mg Tablets Altercast 5mg Tablets
Each chewable tablet contains:- Each chewable tablet contains:-
Montelukast (as Sodium)……5mg Montelukast (as Sodium)……5mg
(Wnsfeild Specfication) (USP Specfication)
4. -do- 075589 Altercast 4 mg sachet Altercast 4 mg sachet
Each sachet contains:- Each sachet contains:-
Montelukast Sodium Montelukast Sodium
≡ Montelukast…4 mg ≡ Montelukast…4 mg
(Wnsfeild Specification) (USPSpecification)
5. -do- 068226 Hebnores 300mg Tablets Hebnores 300mg Tablets
Tenofovir disoproxil Fumarate…300 mg Tenofovir disoproxil
(Wnsfeild Specification) Fumarate..300 mg
(International Pharmacopeia
Specification)
6. -do- 083143 Vildrozon 50mg Tablets Vildrozon 50mg Tablets
Vildagliptin…… 50 mg Vildagliptin…… 50 mg
(Wnsfeild Spec) (As per Innovator’s
Specification)
7. -do- 082546 Vildromet Tablets Vildromet Tablets
Vildagliptin….50 mg Vildagliptin….50 mg
Metformin Hydrochloride……500mg Metformin
(Wnsfeild Spec) Hydrochloride……500mg
(As per Innovator’s
Specification)
8. M/s 078478 Russowrd 10 mg Tablets Russowrd 10 mg Tablets
Welwrd, Each film coated tablet contains:- Each film coated tablet contains:-
Hattar Rosuvastatin as calcium…10 mg Rosuvastatin as calcium…10 mg
(Welwrd Specification) (As per Innovator’s
Specification)
9. -do- 078480 Russowrd 20 mg Tablets Russowrd 20 mg Tablets
Rosuvastatin as calcium…10 mg Rosuvastatin as calcium…10 mg
(Welwrd Specification) (As per Innovator’s
Specification)
The new brand names have been issued in accordance with the authorization given to
the Chairman Registration Board for this purpose. The required correction of specifications, as
mentioned against each product, is submitted for consideration by the Registration Board
Decision: - Registration Board approved the correction in specifications of products at

S.No.1-9 of above table as per details mentioned in the last column.
Case No.36 Correction in Specifications of Registered product of M/s Aries
Pharmaceuticals, Peshawar.
M/s Aries Pharmaceuticals, Peshawar had applied for change in source of Esomeprazole
pellets from M/s Murli Krishna, India to M/s Rovoos Laboratories, India for their following
product. During evaluation it was noted that corrections are required in specification of this
product. The details are as under:
S.# Name of Regn. Brand Name with Composition & Brand Name with Composition &
Firm No. existing Specifications Correct Specification
1 M/s 054529 Esox 40mg Capsule Esox 40mg Capsule

Aries,
Peshawar Each capsule contains:- Each capsule contains:-
Esopmerazole coated pellets of Esopmerazole coated pellets of
magnesium trihydrate eq to magnesium trihydrate eq to
esomperazole….40mg esomperazole….40mg
(Aries Specifications) (USP Specifications)
The new source of pellets has been approved in accordance with the authorization given to
the Chairman Registration Board for this purpose. The required correction of specifications, as
mentioned above, is submitted for consideration by the Registration Board.
Decision: - Registration Board approved the correction in finished product specifications

of Esox 40mg capsule from “Aries Specifications” to “USP Specification”.
Case No.37 Approval Granted to M/s WnsField Pharmaceuticals, Hattar
M/s Wns FeildPharmaceuticals, Hattar was granted approval for registration of the
following product vide 273rd meeting of Registration Board. Details are as under:
S.No Name of drug (s) & Detail of Decision of Remarks
Composition submissions/ M-273
Dy.No.
1 Noxiwin 8mg Injection Dy. No. 61; 02- Approved After clarification received
Each injection of 2 ml 03-2016; with from PEC stating that
contains: Rs.20,000/- (02- Innovator‘s ―there has been a drafting
Lornoxicam……..8mg 03-2016) error in the minutes while
specification
As per policy of the original formulation is
MOH powder for Injection‖
the label claim has been
standardized as under:
―Each injection contains:
Lornoxicam…..8mg‖
As evidence of approval of Dry Powder Injectable (General) section and GMP status, the
firm has submitted panel inspection report conducted for renewal of DML dated 18-01-2018 with
―As per observation made, facilities of production and quality control inspected, technical
staff employed and keeping in view the overall GMP compliance status of the firm, the
panel unanimously recommend the renewal of DML No.000610 by way of formulation
granted to M/s Wnsfeild Pharmaceuticals, Hattar.”
Decision: - Registration Board deferred the case for clarification regarding availability of
Lornoxicam in ready to fill lyophilized powder form.
Case No.38 SOP For Post Registration Variations.
The Registration Board, vide its 240th meeting, has approved following SOPs for approval
of post registration variations
Standard Operating Procedures for approval of post-registration variations.
Pharmaceutical Evaluation & Registration Directorate briefed that after grant of
registration, certain variations are required to be approved. The Directoarte has prepared Standard
Operating Procedures for all such variations. These SOPs will serve as guideline for the applicants
and will also facilitate efficient working and timely disposal of cases by the Directorate.
Decision:
Registration Board discussed SOPs and approved following SOPs for implementation.
A. Locally manufactured products:
1. Change in excipients (inactive) including flavor/ colour

a. Application with required fee as per relevant SRO.
b. Copy of registration letter and renewal status.
c. NOC for CRF clearance.
d. Specification of existing and proposed excipients / Flavour / Colour.
e. Document confirming that proposed expcipient / inactive is of pharmaceutical grade.
f. Data for 06 months accelerated stability studies.
g. Undertaking that real time stability studies would be continued till whole of shelf life &
in case of OOS (out of specifications), the applicant will inform PE&R accordingly.
h. In case of additional flavor, Application on Form 5 with full fee will be submitted.
2. Change of source of pellets

d. Real time stability studies of pellets conducted by manufacturer as per conditions of zone
IV-A as per ICH guidelines (Both real time & accelerated studies).
e. Certificate of analysis of manufacturer
f. GMP certificate from regulatory authority of exporting country.
g. Undertaking that shelf life of finished product would be assigned from date of
manufacturing of pellets from manufacturer.
3. Transfer of registration
i) With change in manufacturing site:
a. Application with Form-5 and required fee as per relevant SRO.
d. Copy of approved section by Central Licensing Board.
e. Copy of last inspection report.
f. NOC from existing manufacturer / registration holder permitting for transfer of product.
g. Statement / undertaking that applicant do not have registration of same products. If so, it
has to apply for cancellation of product.
h. Accelerated stability studies of 6 months with undertaking to conduct real time stability
studies up to assigned shelf life & report if any result falls outside shelf life specifications
(with proposed action).
i. Validated method of analysis, master formula and product development data
ii) Change in name / title of manufacturer (site of manufacturing remains the same)
a. Application on Form-5 with required fee as per relevant SRO.
d. Approval of new name / title from CLB.
e. Undertaking that the formulation, API source & Specifications, manufacturing process,
release & shelf life specifications have not changed.
4. Change in storage conditions/shelf life

d. Real time stability data.
5. Change in Prescribing Information (PI)

d. Difference between existing and proposed information in tabulated form.
e. Justification of proposed changes.
f. Reference of prescribing information of brand leader (for me too products).
g. Copy of approval from regulatory agency / authority from country of origin for brand
leader.
h. Copy of label outer pack in case of changes indication/ dose/ administration etc.
6. Change in primary packaging.

d. Justification of proposed change.
e. Accelerated stability studies of 6 months with undertaking to conduct real time stability studies
up to assigned shelf life & report if any result falls outside shelf life specifications
(with proposed action).
f. Shelf life of the drug product supported with justification.
7. Change of packaging materials.

e. Existing and proposed packaging materials.
f. Difference between existing and proposed information in tabulated form.
g. Confirmation and undertaking that proposed label complies all provisions of Drugs
(Labeling & Packing) Rules, 1986.
h. An undertaking that the proposed colour scheme / label has no resemble with
already registered Products. In case of resemblance, new label will be changed
immediately. Moreover, no case is pending at any forum / court of law regarding this
matter.
i. Dosage, administration, indication & direction for use etc. on the label be in line with
marketing authorization.
8. Registration of drug for export purpose.

a. Application on Form 5 with required fee as per relevant SRO.
b. NOC for CRF clearance.
c. Copy of approved section from CLB.
d. Copy of last inspection report.
e. An undertaking that applied registration is exclusively for export purpose and will not
be sold in Pakistan.
f. If formulation / product is not registered in Pakistan, then export order from
importing country.
9. Change of brand name.

a. Application with required fee as per relevant SRO (in case of similarity / resemblance
with already registered drug, fee will not be required).
d. Justification for proposed change.
e. Information regarding previous change of brand name since registration of drug.
f. Details (batch number, date of manufacture, quantity and stock position) regarding last
batch manufactured.
g. An undertaking that the proposed names do not resemble with already registered brands.
/similarity with already registered drug, the applicant will be liable to change immediately.
Moreover, at any forum / court of law regarding this matter.
10. Change in shape of tablet / color and size of capsule.

e. Undertaking that other specification of the product would remain the same.
11. Cancellation of registration of drug on firm’s request.

a. Application.
d. Justification
e. List of alternatives brands available in the country.
f. An undertaking that the no case is pending at any forum / court of law regarding this
product.
12. Renewal of drugs applied after due date.

b. Copy of registration letter and last renewal status.
d. Reason for not submitting renewal in time.
13. Corrigendum for correction in registration letter.
a. Application with required fee as per relevant SRO, if error is on part of firm.
d. Document in support of proposed correction.
B. Imported products:
1. Change of name of manufacturer of imported drugs

d. Original and legalized Certificate of Pharmaceutical Product as per WHO format for new
manufacturer‘s name OR Original and legalized GMP certificate of new manufacturing site
with free sale certificate from regulatory body of country of origin.
2. Change of manufacturing site/source

a. Application on Form 5A with required fee as per relevant SRO.
manufacturer‘s name OR Original and legalized GMP certificate of new manufacturing
site with free sale certificate from regulatory body of country of origin.
e. Site master file of new manufacturing site.
3. Increase or decrease in shelf life of finished products

e. Approval of regulatory body of country of origin / Original and legalized Certificate of
Pharmaceutical Product as per WHO format.
f. Stability data for Zone IV A or for respective storage condition (in case of products to be
stored at 2-8 0C).
4. Transfer of registration from one importer to other importer

d. Termination letter (original) from manufacturer for previous importer.
e. Authority letter/sole agent letter (original) from manufacturer.
f. NOC from existing registration holder for transfer of registration.
5. Change of packaging materials.

e. Existing and proposed packaging materials.
f. Difference between existing and proposed information in tabulated form.
g. Confirmation and undertaking that proposed label complies all provisions of Drugs
(Labeling & Packing) Rules, 1986.
h. An undertaking that the proposed colour scheme / label has no resemble with already
registered Products. In case of resemblance, new label will be changed immediately.
Moreover, no case is pending at any forum / court of law regarding this matter.
i. Dosage, administration, indication & direction for use etc. on the label be in line with that
authorization.
j. Regulatory approval of change from country of export.
6. Change of brand name.

a. Application with required fee as per relevant SRO (in case of similarity / resemblance with
drug, fee will not be required).
e. Information regarding previous change of brand name since registration of drug.
f. Details (batch number, date of manufacture, quantity and stock position) regarding last
batch imported.
g. An undertaking that the proposed names do not resemble with already registered brands.
In case of resemblance/similarity with already registered drug, the applicant will be liable
to change immediately. Moreover, no case is pending at any forum / court of law
regarding this matter.
h. Original and legalized Certificate of Pharmaceutical Product as per WHO format for new brand
name OR Original and legalized GMP certificate of new brand name with free sale
certificate from regulatory body of country of origin.
The case was deferred by the Registration Board in its 278th meeting for comments of
PPMA and Pharma Bureau.
Registration Board deferred the case in 279th meeting with the advice to stakeholders to
furnish their comments at the earliest.
Decision: - Registration Board deferred the case for further deliberation in its forth
coming meeting.
Case No.39 Risks & Concerns Associated With Dydrogesterone.
A number of applications have been received by Pharmaceutical Evaluation & Registration

Division for registration of Dydrogesterone Tablets. While evaluation, it was identified that the
applied formulations were based on "Cis Isomer" of Dydrogesterone i.e not in compliance with
the USP monograph for dydrogesterone tablet & European Pharmacopeial monograph for
dydrogesterone API, both of which state "trans isomeric form".
The observation was further confirmed by reviewing innovator‘s formulation approved by

following Reference Regulatory Authorities:
a. ANSM France (Duphaston, Authorization Holder: MYLAN MEDICAL SAS)

b. CBGMEB Netherlands (Duphaston; Reg. No. RVG 107765/ 05619)
c. AGES Austria (Duphaston, Owner: BGP Products GmbH, Perfektastrasse 84A, 1230
Vienna, Austria)
d. Swissmedic Switzerland
Concerns Raised By Abbott Laboratories:
M/ s Abbott Laboratories (Pakistan) Ltd. has raised the same issue and highlighted following
points of concern & risks associated with the use of mislabeled Dydrogesterone:
 Solvay Pharmaceuticals is the only company in the world which manufactures

dydrogesterone because manufacturing requires a proprietary technique.
 In Pakistan, dydrogesterone was only marketed by Solvay‘s agents, Highnoon
Laboratories Limited under the brand name of DUPHASTON i.e currently owned by
Abbott Laboratories.
 Dydrogesterone manufacturing process involves, as an essential step, a photochemical
reaction which leads to conversion of configuration. The manufacturing of 6-
dehydroprogesterone lacks the photochemical conversion step resulting in substantially
different 3D structure.
 Different structures lead to different pharmacological profile such that efficacy of these
two molecules differ significantly.
 The clinical data on efficacy and/or safety is not available for 6-dehydroprogesterone
lacking the proof that this is any beneficial for the patient. As there is no data in support of
6- Dehydroprogesterone, it cannot be evaluated in comparison to dydrogesterone in terms
of safety & efficacy.
Furthermore, M/s Abbott has submitted following supportive studies:
i. Drug analysis conducted on products claiming as dydrogesterone at:

1) Abbott‘s MS&T Analytical Sciences & Technology, Weesp, The Netherlands.
2) Industrial Analytical Center, HEJ Research Institute of University, University of
Karachi.
The results of the chemical analysis revealed the main component as 6-

dehydroprogesterone & not dydrogesterone.
ii. Results Deduced From Comparative Molecular Modeling Study:
Dydrogesterone possesses a biological potency significantly higher than progesterone

itself as it takes advantage both from its retro structure and from the presence of the C6-
C7 double bond, which constricts the molecule into a rigid conformation probably
suitable for the interaction with the progesterone receptor. Moreover, as a consequence of
its better bioavailability and the progestational activity of its main metabolites (20-, 21-
and 16-hydroxy derivatives), its equivalent dose, regarding the endometrial proliferation,
is 10-20 times lower than that of progesterone itself.
Previous Proceeding:
In 2008 M/s Zafa Pharmaceutical Laboratories (Pvt) Ltd. Karachi, appealed before the
Appellate Board against the decision of Registration Board regarding stoppage of production of
their drug "Dirogest Tablets" containing "Dydrogesterone Cis Isomer", for local manufacture. The
Appellate Board in its 134th meeting held on 17-06-2008 after considering the following
arguments & merits of the case, accepted the appeal since no scientific evidence contravened the
arguments made by M/s Zafa.
Mr. Muhammad Amin Khan, C.E.O., Mr. Jawad Amin Khan, MD, Mr.
Muhammad Aslam Shah, GM Technical & Mr. Hassan Masood Naqvi, Assistant
Sales Manager of the firm appeared before the Board on behalf of the firm &
stated that "Dirogest Tablets" containing "Dydrogesterone Cis Isomer was
registered in 2002 and since then they are marketing the said drug without any
complaint from the doctors/ market. They had been selling more than 100000
packs per year & no complaint had been received about their efficacy. They
further added that the said drug was also available in Israel & Syria. They
informed the board that comparative study of the two different dosage of the
drug had been conducted in John Hopkins Bloomberg School of Public Health
and some trials in different hospitals in Pakistan had been conducted. They also
informed the board that their drug was cheaper than its competitors in the
market.
It is however, submitted that Duphaston is the proprietary name of the dydrogesterone
containing product registered by Ministry of Health, Israel in the name of ABBOT
MEDICAL LABRATORIES LTD, ISRAEL. Moreover, M/s Zafa, in order to prove their
stance, is obliged to provide data regarding aforementioned comparative study.
Findings:
Besides progesterone, the natural progestational agent, many synthetic progestins are
known. One of the classes is represented by ―Retrosteroids‖ and the most representative
compound among these is 6-dehydroretroprogesterone (dydrogesterone). Another progestin
considered in this regard is 6-deydroprogesterone (Cis Isomer), having a molecular structure
almost identical to that of 6-dehydroretroprogesterone (dydrogesterone), however in
dydrogesterone molecule, the hydrogen atom at C-9 is at beta position & methyl group at C-10 is
at the alpha position (Figure1). Whereas 6-Dehydroprogesterone has a reverse configuration at
position C-9 & C-10 (Figure2), hence the term ‗retro‘ progesterone. The acetyl group at C-17 in
both structures have same configuration.
Structural Comparison of 6 – Dehydroprogesterone and Dydrogesterone
Figure1
Figure 1
Both the isomers have different physical properties confirming these to be different
pharmaceutical entities.
S.No. Attributes Cis Isomer Trans Isomer

1 Chemical Name 6-Dehydroprogesterone 6-Dehydroretroprogesterone
2 Molecular Weight 312.45 312.45
4 CAS Number 1162-56-7 152-62-5
5 Specific Rotation +170º- +182º -469-485(dried
substance)measured at 25ºC
6 Melting point 142-148ºC 167-171ºC
7 Relative Retention Time 1.17 min 1min
towards Dydrogesterone
(Reverse phase HPLC with
UV Detector)
USP38-NF33
Registration Board deferred the case in 279th meeting with the advice to stakeholders to
furnish their comments at the earliest.
Decision: - Registration Board deferred the case for further deliberation in its forth
coming meeting.
Registration-V
Case No.40 Registration of M/s. Wilshire Laboratories (Pvt) Ltd, Lahore.
a) The following product of M/s. Wilshire Laboratories was deferred in 212th meeting for
expert opinion as per detailed below:-
Name of product with composition Pack Size. Demanded Decision

Price.
Clean Up Tablets 180mg 1x10‘s 15% less Deferred for expert
Each tablet contains:- than brand opinion
Fexofenadine HCl …..180mg leader
Pseudoephedrine ……………….240mg
(Anti histamine)
The case was again presented in before Registration Board 213th meeting wherein following
correction were noted as per detailed below:-
S. Name of Product. Name of Product with Decision Remarks

No correct formulation
1. Clean Up Tablets Clean Up Tablets Decision:- The Formulation approved
120mg 180mg request of the firm by FDA as ―Each
Each tablet contains:- Each tablet contains:- was acceded extended release tablet‖.
Fexofenadine HCl Fexofenadine HCl subject to change
….120mg …..180mg
of name Proposed brand name
Pseudoephedrine Pseudoephedrine
…240mg …240mg
Sizzle D.
(Anti histamine) (Anti histamine)
The firm has submitted differential fee of Rs.12000/- dated 16.12.2014 . Now the firm has
requested for registration of above mentioned product.
Decision: Registration Board approved above mentioned product.
b) Following products of M/s. Wilshire Laboratories were approved in 228th meeting of

Registration Board as per detailed below:-
Sr.no Name of firm Name of product and Demanded Demanded Decision

composition pack size MRP
1. M/s. Wilshire Benzim Plus 20/100mg 10‘s As Per SRO Approved
Laboratories Each capsule contains:- 14‘s Subject to
Lahore Omeprazole….20mg 28‘s humidity
Sodium Bicarbonate….1100mg 30‘s control
system
monitoring.
2. -do- Benzim Plus 40/100mg 10‘s As Per SRO Approved
Each capsule contains:- 14‘s Subject to
Omeprazole….40mg 28‘s humidity
Sodium Bicarbonate….1100mg 30‘s control
system
monitoring.
Firm has submitted following documents:-

i. Application for this purpose.
ii. Copy of fee challan of Rs.12000/- for each product dated 16.12.2014.
iii. Last GMP Inspection dated 18-5-17 with conclusive remarks of satisfactory level
of cGMP compliance
Firm has requested for issuance of registration of above mentioned products
Decision: The Board was apprised that HVAC system has been verified from panel
inspection report for the purpose of DML renewal dated 03.10.2007 thus
Registration Board allowed issuance of registration of above mentioned
product.
Case No.41 Registration of M/s. Remington Pharmaceuticals (Pvt.) Ltd, Lahore.

Registration Board in 255th meeting approved the following products of M/s. Remington
Pharmaceuticals (Pvt.) Ltd, Lahore for transfer of registration form old manufacturing site i.e 117-
Allama Iqbal Road to new manufacturing to 18-Km Multan Road, Lahore as per detailed below:-
S.No Reg No Name of Drug & Composition

1 050884 Loxiget Eye Drops
Each ml contains-
Gatifloxacin ……………… 3mg
(Remingtons‘s Specs)
2. 050877 Dozypress-T Eye Drops
Each ml contains:-
Dorzolamide ……………………… 20mg
Timolol maleate equivalent to
Timolol …………………………….. 5.00mg
(Remington‘s Specs)

Cancellation of above registrations from name of manufacturer M/s. Remington
Pharmaceuticals (Pvt.) Ltd; 117-Allama Iqbal Road, Lahore to 18 km Multan
Road, Lahore
 Grant of above registrations in name of M/s. Remington Pharmaceuticals
Industries (Pvt.) Ltd; 18-KM Multan Road, Lahore. Case will be referred to Cost
& Pricing Division about MRP of the drug.
Decisions have been taken by Registration Board in similar cases wherein there is no any
direction for cancellation of registration and reference to Cost & Pricing Division. Moreover,
decision taken by Registration Board regarding case of same firm in 269th meeting for transfer of
registration of product Dexcip Ear Suspension Reg No. 050908 is mentioned below:-
“Registration Board decided to approve registration of above product of M/s
Remington Pharmaceuticals Industires (Pvt) Ltd, Lahore at new site i.e 18-Km Multan
Road, Lahore”
Hence correction in minutes solicited in this regard and letter may be issued accordingly.
Decision: Registration Board noted correction in minutes of 255th meeting and decided
to approve registration of above product of M/s Remington Pharmaceuticals
Industires (Pvt) Ltd, Lahore at new site i.e 18-Km Multan Road, Lahore
Case No.42 Registration of M/s. Murfy Pharmaceuticals (Pvt.) Ltd, Lahore.

Registration Board in 227th meeting deferred the following product of M/s. Murfy
Pharmaceuticals (Pvt.) Ltd, Lahore as per detailed below:-
Sr.No Name of product Demanded Demanded Decision

pack size MRP
1. Nimril Tablets 100mg 1*10 tablets As per Deferred for
Each film coated tablet contains:- S.R.O review
Nimsulide (BP)…100mg. committee
Firm has submitted following document:-

i. Application with differential fee of Rs. 12000/ on dated 27.02.2018.
ii. GMP inspection report dated 17.03.2016
Since above mentioned formulation has been approved by the Registration Board in 269th meeting
hence firm requested to grant registration.
Case No.43 Registration of M/s. Xenon Pharma, Lahore.

Registration Board in 228th meeting deferred the following products of M/s. Xenon
Pharma, Lahore as per detailed below:-
Sr.N Name of firm Name of product and Demande Demanded Decision

o composition d pack MRP
size
1. M/s. Xenon Co-Kasamol Syrup 60ml Rs.69.00 Approved

Pharma, Lahore. Each 5ml contains:-
Paracetamol…….120mg Approval status in
Codeine stringent regulatory
phosphate…..12mg authority not
confirmed
i. Application with remaining fee of Rs. 12000/ on dated 29.03.2018.
ii. GMP inspection report dated 16-02-2017.
iii. Section approval was verified from CLB
The firm has requested for granting registration of above mentioned product.
Decision: Registration Board was apprised that applied formulation is available in

USFDA.Accordingly Registration Board approved above mentioned product.
Case No.44 Cancellation of registration of product of M/s. Medipharm (Pvt) Limited,

Lahore.
M/s. Medipharm (Pvt) Limited, Lahore has requested for the cancellation of
registration of below mentioned product as per detailed below:
Sr.No Reg.No Name of product and Justification/ Remarks

composition reason
1. 006899 Noctamid 0.5mg Tablet Dosage regimen for Adult dosage as per MHRA
Each tablet contains:- noctamid tablet 0.5-1.5mg
Dated Lormetazapam..0.5mg supports 1mg as a
12th single dose (source:http://www.mhra.go
May v.uk/home/groups/spcpil/doc
1984 uments/spcpil/con15006155
53261.pdf)

i. Application for this purpose.
ii. Copy of registration letter.
iii. Justification/reason for cancellation of registration.
The case was presented before Registration Board in 268th meeting and decided as follows:
Decision: Registration Board deferred the case of M/s Medipharm, Lahore for clarification
as product is approved by MHRA, UK and firm is not manufacturing above
product.
According to firm Noctamid 0.5mg tablet was neither manufactured nor renewed.
Moreover it will not be manufactured in future. Firm requested to cancel registration of above
mentioned product so that they get quota fixation for their product Noctamid tablet 1mg (Reg no
006900) else it will create shortage in market.
Decision: Registration Board referred the case for views of DRAP's availability
committee.
Case No.45 Change in formulation for the registered products of M/s. Schazoo Zaka (Pvt)
Ltd, Sheikhupura.
M/s. Schazoo Zaka (Pvt) Ltd, Sheikhupura has requested for revision of formulation as per WHO
recommendations of below mentioned product as per detailed below:
Sr.No Name of product and Reg No. Applied composition as per

composition WHO
1. Rifapin-H Junior 044706 Rifapin-H Junior

Rifampicin………………60mg Rifampicin………………….75mg
Isoniazid…………………30mg Isoniazid……………………50mg
2. Rifatol tablet 016638 Rifatol tablet

Each film coated tablet contain:- Each film coated tablet contain:-
Rifampicin …………….150mg Rifampicin ……………….150mg
Isoniazid …………………75mg Isoniazid ………….……….75mg
Ethambutol HCl…………300mg Ethambutol HCl………..…275mg
3. Rifazole Junior Sachet 044707 Rifazole Junior Sachet
Rifampicin …….………..60mg Rifampicin ……………….75mg
Isoniazid …………………30mg Isoniazid …………….….…50mg
Pyrazinamide …………..150mg Pyrazinamide ………….…150mg
4. Rifazole Pediatric Tablet 031134 Rifazole Pediatric Tablet
Each tablet contains:- Each film coated tablet contains:-
Rifampicin ………..….60mg Rifampicin …….……..….75mg
Isoniazid ……………….30mg Isoniazid …………….……..50mg
Pyrazinamide ………….150mg Pyrazinamide …………..…150mg

i. Application with fee of Rs. 20,000/ for each product on dated 19.03.2018.
ii. Form-5
iii. Last GMP Inspection report dated 01.06.2017 operated as good GMP guideline.
Decision: Registration Board approved change in formulation of above mentioned

products. Reference shall be sent to Cost & Pricing Division for MRP
confirmation/fixation of new formulations.
Case No. 46 Registration of M/s. Trigon Pharma Lahore

The Drug Registration Board in its 229th meeting had deferred the following product of
M/s. Trigon Pharma Lahore for GMP and product specific inspection:-
S.No Name of Product and composition Demanded pack size Demanded MRp
1. Sucron Injection 5x5ml As per SRO

Each ml contains:-
Iron as Iron sucrose……….20mg
Decision: The Board did not approve firm‟s request and deferred the application
for product specific inspection by Director DTL, Lahore and Area FID.
The firm has deposited differential fee of Rs. 12000/- dated 16.12.2013 for this purpose.
The firm has informed that it is common product and many of companies are manufacturing this
product. They have got renewal of Drug Manufacturing License after panel inspection of GMP.
They have requested for grant of registration of above mentioned product. Firm has submitted
latest GMP inspection report conducted on 14.02.2018 wherein firm considered to be operating
satisfactory level of GMP compliance and requested for issuance of registration.
Case No. 47 Registration of M/s. Shrooq Pharmaceuticals (Pvt) Ltd, Lahore.

Registration Board in 238th meeting deferred the following products of M/s. Shrooq
Pharmaceuticals (Pvt) Ltd, Lahore as per detailed below:-
Name of product and Demande Decision Remarks/ SRA

Sr.No composition d pack approval
size/MRP
1. Sanron Tablets 10‘s Approved. The Board The firm has
Each film coated tablet As per advised to provide finished submitted revised
contains:- SRO product specifications and formulation wherein
Ondansetron replace Methylene Chloride. Methylene Chloride
Hydrochloride…….8mg has been replaced and
(Gastrointestinal) finish product
specifications.
FDA approved
2. Valrox Syrup 60ml Approved. The Board The firm has

Each 5ml contains:- As per advised to submt finished submitted finish
Divalproex SRO product specifications. product specifications
Sodium…….500mg wherein formulation
(Anti-epileptics) clarified as Divalproex
Sodium eq.to Valproic
Acid.
Not confirmed
MHRA approved
formulation
200mg/5ml
3. Nepzil Tablets 28‘s Approved. The Board The firm has
Each film coated tablet As per advised to replace submitted revised
contains:- SRO Methylene chloride and formulation wherein
Donepezil provide Methylene Chloride
HCl…………5mg Dissolution test method. has been replaced and
(Acetylcholinesterase dissolution profile.
inhibitor)
FDA approved
4. Nepzil Tablets 28‘s Approved. The Board The firm has
Each film coated tablet As per advised to replace submitted revised
contains:- SRO Methylene chloride and formulation wherein
Donepezil provide Dissolution test Methylene Chloride
HCl…………..10mg method. has been replaced and
(Acetylcholinesterase dissolution profile.
Inhibitor)
FDA approved
Firm has submitted following documents:-

i. Application for registration
ii. Latest GMP inspection dated 07.06.2017&30.08 2017
iii. Evidence of fee submission
iv.
Decision: Registration Board considered the case and decided as follows:
i) Approved products mentioned at Sr. no. 1, 3 and 4
ii) Deferred product mentioned at Sr. no. 2 for approval status in
stringent regulatory authority
Case No.48 Registration M/s. Life Pharmaceutical Company, Multan.

Registration Board in its different meetings approved following products of M/s. Life
Pharmaceutical Company, Multan as per detailed below:
Sr. Name of the drugs with Pack Proposed Decision Remarks
No composition Size Price
1. Adaplex Cream 0.1 % w/w 15gm Rs.300.00 Approved ANSM
Each gram contains:- 45gm Rs.800.00 (M-234) approved
Adaplene…..0.1% w/w
(anti acne preparations)
2. Mrimus Ointment 0.03% 5gm Rs.300.00 Approved USFDA
Contains:- (M-234) approved
Tacrolimus…..0.03% w/w
(atopic dermatitis)
3. Neurotin Capsule 300mg 1x10‘s Rs.375.00 (M-236) MHRA
Each capsule contains:- 2x10‘s Rs.728.00 approved
Gabapentin…..300mg 3x10‘s Rs.970.00
(anti epileptic/ Neutopathic ) 10x10‘s Rs.3270.00
4. F-Con Dry Suspension 35ml Rs.400.00 (M-236) MHRA
Each 5ml contains:- 60ml Rs.600.00 approved
Fluconazole…….50mg
(antifungal)
Firm has submitted last GMP inspection report (dated 31.05.2016) evidence for section
approval and evidence for differntial fee submission (12000/-). Firm has requested for issuance of
registration letter of above mentioned products.
The case was again presented in 276th meeting and decided as follows:-
Decision: Registration Board deferred the above products of M/s Life Pharmaceutical
Company, Multan for GMP inspection report conducted during last 1 year.
Now the firm has submitted latest GMP inspection report dated 15.01.2018, wherein firm
is considered to be operating at SATISFACTORY level of GMP compliance.
Decision: Registration Board approved above mentioned products.
Case No.49 Registration of M/s. Rasco Pharmaceuticals (Pvt.) Ltd, Lahore.

Registration Board in 212th meeting deferred the following product of M/s. Rasco
Pharmaceuticals (Pvt.) Ltd, Lahore as per detailed below:-
Sr.No Name of product Demanded Demanded Decision

pack size MRP
1. Resulid Tablet 100mg. 2x10‘s Rs.95.00 Deferred till the
Each Tablet Contains:- installation of
Nimesulide………. 100.0mg. HVAC.
(B.P)
i. Application with differential fee of Rs. 12000/ on dated 05.04.2018.
ii. GMP inspection report dated 17th &24th March, 2018, cosidered to be operating at
FAIR level of cGMP compliance and recommended cGMP certificate to firm
Since above mentioned formulation has been approved by the Registration Board in 269th meeting
hence firm requested to grant registration.
RRR SECTION
Case No. 50 Cases received in accordance with SRO 1005(I) 2017

Federal Government vide SRO 1005(I)/2017 dated 5th October, 2017 approved the
amendment in Rule 27 (PR&A) of 1976 for the consideration of renewal of Registration after 60
days of expiry of registration of drugs. This SRO has been placed in 275 th meeting of Registration
Board for information and record. Furthermore, decision in the light of opinion of Legal Affair
Division regarding submission of fee for the regularization of renewal of their product vide SRO
mentioned above. . In this regard more than 1300 applications received in this RRR-Section of
PE&R Division till 04th December, 2017.
Deferred Cases of Previous Meetings
i. Locally Manufactured (Human)

I II III IV V VI
Sr. Date of
Firm Name Reg. No. Brand Name Decision
No. Reg.
1. M/s. Biorex 068570 Biodic SR 100mg Capsule 04-01-2011 w.e.f. 04-01-2016

Pharmaceuticals, Each capsule contains:- to 03-01-2021
Islamabad. Diclofenac sodium …. 100mg
Pellets are imported from M/s.

LEE Pharma Ltd., Survey
No.199,Plot
No.3&4,D.NO.5.9-265/1 &
2,RAJIVE GANDHI
NAGAR,PRASANTHI
NAGAR
INDL,EXTENSION,KUKAT
PALLY,Hyderabad-
72,A.P.,India
2 Atlantic 052478 Tran-sol infusion 5% 16-09-2008 w.e.f 16-09-2013 to

Pharmaceutical Each 100ml contains: - 15-09-2018
Laboratories, Dextrose anhydrous …. 5g
Peshawar Water for injection…1000ml
3 Atlantic 052479 Tran-sol DS infusion 16-09-2008 w.e.f 16-09-2013 to

Pharmaceutical Each 100ml contains: - 15-09-2018
Laboratories, Dextrose anhydrous …. 5g
Peshawar Sodium Chloride …. 0.9g
Water for injection…1000ml
4 Atlantic 052480 Tran-sol NS infusion 16-09-2008 w.e.f 16-09-2013 to
Pharmaceutical Each 100ml contains:- 15-09-2018
Laboratories, Sodium chloride …. 0.9g
Peshawar Water for injection…1000ml
5 Atlantic 047720 Ciprosol infusion 100ml 04-10-2007 w.e.f. 04-10-2017
Pharmaceutical Each 100ml contains:- to 03-10-2022
Laboratories, Ciprofloxacin (USP) ….
Peshawar 200mg Regularisation of
renewal of year
2012 from
04-10-2012 to
03-10-2017
6. Atlantic 047721 Klorosol inj 25ml 04-10-2007 w.e.f. 04-10-2017

Pharmaceutical Each vial contains:- to 03-10-2022
Laboratories, Potassium Chloride …. 7.46%
Peshawar w/v Regularisation of
renewal of year
2012 from
04-10-2012 to
03-10-2017
7. Atlantic 047722 Glucosol injection 25ml 04-10-2007 w.e.f. 04-10-2017

Pharmaceutical to 03-10-2022
Laboratories, Each vial contains:-
Peshawar Regularisation of
Dextrose anhydrous …. 25% renewal of year
w/v 2012 from
04-10-2012 to
03-10-2017
8. M/s. Libra (Pvt) 023761 RI-Q Tablet 250mg 13-11-2001 w.e.f.13-11-2016 to

Ltd., Peshawar. 12-11-2021
Each tablet contains:- Change of
Brand
Ciprofloxacin …. 250mg name on
10-12-2004
9. M/s. Libra (Pvt) 023762 RI-Q 500mg 13-11-2001 -do-

Ltd., Peshawar.
Each tablet contains:- Change of
Brand
Ciprofloxacin …. 500mg name on
10-12-2004
10. M/s. Libra (Pvt) 023806 Selectin Syrup 26-10-2001 w.e.f.26-10-2016 to

Ltd., Peshawar. 25-10-2021
Each 5ml contains:-
Loratadine …. 5mg
11. M/s. Libra (Pvt) 023805 Selectin Tablet 26-10-2001 -do-

Ltd., Peshawar.
Each tablet contains:-
Loratadine …. 10mg
12. M/s. Neomedix 023102 Agapurin-Retard 400mg Tablet Transfer of Firm submitted
Registratio reply in which they
Each tablet contains:- n from Toll stated that outgoing
Pentoxifyline …. 400mg Manufactur management did
ing to own not handed overall
premises record, so initial
registration letter is
Dated not found in their
03-12-2008 record.
13. M/s. Miracle 068863 Q-Dol Tablet 05-07-2010 w.e.f. 05-07-2015

Pharmaceuticals to 04-07-2020
(Pvt) Ltd., Each tablet contains:- Change of
Rawat, brand name
Alfacalcidol …. 0.5mcg dated
Islamabad.
01-06-2013
14. Amson Vaccines 029064 Amsim Tablet 10 mg 31-12-2002 w.e.f.09-01-2014 to

& Pharma (Pvt.) 08-01-2019
Ltd., Islamabad Each tablet contains: Transfer of
registration
Simvastatin USP 10 mg dated
09-01-2004
15. Amson Vaccines 029065 Amsim Tablet 20 mg 31-12-2002 -do-

& Pharma (Pvt.)
registration
Simvastatin USP… 20 mg dated
09-01-2004
16. Amson Vaccines 037529 Ciprox Tablet 01-03-2005 w.e.f. 01-03-2015

& Pharma (Pvt.) to 29-02-2020
Ltd., Islamabad Each Tablet Contains:
Ciprofloxacin (as
HCl)…….100mg
17. Amson Vaccines 037530 Ciprox Tablet 01-03-2005 -do-

& Pharma (Pvt.)
Ltd., Islamabad Each Tablet Contains:
Ciprofloxacin (as
HCl)…….750mg
18. Amson Vaccines 027540 Isotham Tablet 04-05-2002 w.e.f. 18-08-2014

& Pharma (Pvt.) to 17-08-2019
registration
Isoniazid BP…..150 mg dated
Ethambutol HCl BP…..400 mg
18-08-2004
19. Amson Vaccines 025847 Pyzam Tablet 22-05-2000 -do-

& Pharma (Pvt.)
registration
Pyrazinamide….. 500 mg dated
18-08-2004
20. Amson Vaccines 025843 Pulmobutol Tablet 22-05-2000 -do-

& Pharma (Pvt.)
registration
Ethambutol…. 400 mg dated
18-08-2004
21. M/s. MKB 047902 Bonjour 0.5mcg Tablet 05-12-2007 w.e.f. 27-03-2015
Pharmaceuticals to 26-03-2020
(Pvt.) Ltd., Each Tablet contains: Change of
Peshawar brand name
Alfacalcidol….0.5mcg dated
27-03-2010
22. M/s. MKB 047901 Bonjour 1mcg Tablet -do- -do-

Pharmaceuticals
(Pvt.) Ltd., Each Tablet contains:
Peshawar Alfacalcidol….1mcg
Decision: Registration Board decided as under;
i) Acceded to request of the firm of products at Sr. No. 01-11&13-22 and

decided to grant/regularize the renewal mentioned against each in column VI.
ii) Deferred the cases of product at Sr. No.12 regarding confirmation of status of
registration by the firm.
ii. Locally Manufactured (Veterinary)

I II III IV V VI
Sr.
Firm Name Reg. No. Brand Name Date of Reg. Remarks
No.
1. M/s. Amarant 041268 W.S. CTC 20% 03-12-2005 w.e.f. 11-03-2016 to
Pharmaceuticals Powder Change of brand 10-03-2021
(Pvt) Ltd., Each 100gm name
Karachi. contains:- from W.S.CTC to
Chlortetracycline Lexi CTC dated
HCI …. 20gm 20-01-2006
Change of
Company name
on
11-03-2011
2. M/s. Westmont 048186 Sulf Amprol Oral 16-07-2008 Firm submitted Initial
Pharmaceuticals Water Soluble Registration Letter,
Industry, Powder Form 5-B and DML.
Gujar Khan Each gm contains: Renewal application
Amprolium Of License is
HCl….166mg submitted late but
Sulphaquinoxaline within 60 days.
Sodium…166mg
Colistin
Sulphate…500 I.U.
Vitamin K3….50mg
Vitamin
A…..5000I.U.
3. -do- 048187 Benzomont Oral 16-07-2008 -do-
powder
Each 1000gm
contains:
Sodium
Benzoate…100g
Ethanol-bi-amino-
phosphoric
acid…100gm
Vitamin A…10MIU
Vitamin
K3…1000mg
Vitamin E…2500mg
4. -do- 048188 Coccimont Water 16-07-2008 -do-
Soluble Powder
Each 100gm
contains:
Sulphamerzine
Sodium….200gm
Sulphaquinoxinaline
sodium…25gm
5. -do- 048190 Flushmont Water 16-07-2008 -do-

Soluble Powder
Each gm contains:
Hexamethylene
tetramine…955.0mg
Vitamin B2
(Riboflavin Sodium
Phosphate)…10.00m
g
Calcium Pantothenate
….05.00mg
Nicotinamide…25.00
mg
6. -do- 048191 Salicorb Oral 16-07-2008 -do-
Powder
Each 1000gm
contains:
Salicylic
acid….200gm
Ascorbic
Acid…600gm
Potassium
Chloride….2gm
Sodium
Chloride…10gm
7. -do- 048192 Tylo-CD Water 16-07-2008 -do-
Soluble Powder
Each gm contains:
Tylosine
tartrate…100mg
Doxycycline
HCl…200mg
Colistin
Sulphate…20,000IU
8. -do- 048193 Zerocox Water 16-07-2008 -do-
Soluble Powder
Each 100gm
contains:
Amprolium
HCl…20gm
Ethopobate…01gm
Sulfadimidine
Na…22.5gm
9. -do- 048194 Albamont Oral 16-07-2008 -do-
Suspension
Each 100ml contains:
Albendazole….7.5%
Cobalt
Sulphate…0.075%
Sodium
Selenite…0.035%
10. -do- 048195 Levol Oral 16-07-2008 -do-
Suspension
Levamisol…1.5%
Oxclozaide…3%
Cobalt
Sulphate…0.167%
Sodium
Selenite…0.050%
11. -do- 048196 Darvimont Water 16-07-2008 -do-
Soluble Powder
Each 1000gm
contains:
Diaveridine….50gm
Sulphaquinoxaline…
200gm
Vitamin A…2.50gm
Vitamin K…05gm
12. -do- 048199 Oxamont Oral 16-07-2008 -do-
Suspension
Oxfendazole…22.65
gm
13. -do- 048200 Oxanide Oral 16-07-2008 -do-
Suspension
Oxyclozanide…7%
Oxfendazole…3%
14. -do- 049557 Coliclor-N Water 05-08-2008 Firm submitted Initial
Soluble Registration Letter ,
Each 1000gm Form 5-B and DML.
contains:
Neomycin Renewal application
Sulphate…70gm Of License is
Colistin submitted late but
Sulphate….4gm within 60 days.
Chlortetracycline
HCl…80gm
15. -do- 053931 Colimont Powder 19-02-2009 Firm submitted Initial
Each 100gm Registration Letter,
contains: Form 5-B and DML.
Colistin
Sulphate…400MIU Renewal application
Methyl Of License is
Paraben…1.5gm submitted late but
Propyl within 60 days.
Paraben…1gm
Dextrose q.s. to
produce…100gm
16. -do- 058933 Coccivet Powder 30-07-2009 Firm submitted Initial
Each Kg contains: Registration Letter ,
Furosemide…20gm Form 5-B and DML.
Manganese
Sulphate…6gm Renewal application
Sodium Of License is
Chloride…10gm submitted late but
Potassium within 60 days.
Chloride….10gm
17. -do- 058934 Coltin 550 Powder 30-07-2009 -do-
Each 100gm
contains:
Colistin
Sulphate…550 MIU
18. -do- 058936 Anrox Plus 10% Oral 30-07-2009 -do-
Liquid
Each ml contains:
Enrofloxacin….10gm
19. -do- 063742 Bromomont Oral 24-09-2010 Firm submitted Initial
Liquid Registration Letter ,
Each 100ml contains: Form 5-B and DML.
Bromhexine…. Renewal application
Of License is
submitted late but
within 60 days.
20. -do- 063743 Liver fit Oral 24-09-2010 -do-
Suspension
Silymarin (Milk
Thistle)..2100mg
Vitamin
E….15000mg
21. -do- 063744 Albawest 2.5% Oral 24-09-2010 -do-
Suspension
Each 100ml
contains:
Albendazole ….2.5%
22. -do- 063745 AB-Triclamont CS 24-09-2010 -do-
Oral Suspension
Triclabendazole…3.7
5%
Albendazole…2.5%
Cobalt
Chloride…0.1%
Sodium
Selenite…0.038%
23. -do- 063746 Enbro-20 Liquid 24-09-2010 -do-
Enrofloxacin…20gm
Bromhexine…5gm
24. -do- 063747 Ampronil-50 Oral 24-09-2010 -do-
Each 1000gm
contains:
Oxytetracycline
HCl…30%
Florfenicol…30%
25. -do- 063748 Normethaprim Oral 24-09-2010 -do-
Liquid
Each Litre contains:
Norfloxacin…7%
Sulfamethoxypyrame
thazine..10%
Trimethoprim….2%
26. -do- 063749 Ascirex Plus Oral 24-09-2010 -do-
Powder
Each Kg contains:
Furosemide..30gm
Vitamin A…10MIU
Vitamin
K3…1000mg
Vitamin E…2500mg
27. -do- 063750 Toltrazic Oral Liquid 24-09-2010 -do-
Toltrazuril…2.5gm
28. -do- 063751 Oxcosel Suspension 24-09-2010 -do-
Each ml contains:
Oxfendazole…22.65
mg
Cobalt
Sulphate….3.82mg
Selenium…0.35mg
29. -do- 063752 Gumbosol Powder 24-09-2010 -do-
Each 100gm
contains:
Ammonium
Chloride..30gm
Sorbitol…5gm
DI-
Methionine…10gm
Vitamin
A…15,00,00IU
Vitamin C…10gm
Acetyl Salicylic
Acid….10gm
30. -do- 063753 Myco-TD 20/40 Oral 24-09-2010 -do-
Powder
Each 100gm
contains:
Doxycycline…40gm
Tylosin
Tartrate…20gm
Decision: Registration Board decided as under;
a. Acceded to request of the firm of product at Sr. No. 01 and decided to

grant/regularize the renewal w.e.f. 11-03-2016 to 10-03-2021
b. Deferred the cases of products at Sr. No.02-30 regarding confirmation of Licensing
Status from Licensing Division.
iii. Finished Drug for Import (Human)

I II III IV V VI
Sr.
Firm Name Reg. No. Brand Name Date of Reg. Remarks
No.
1. M/s. Drug‘s 028464 Brunac Eye Drops 19-07-2003 w.e.f 19-07-2013
Inn, Islamabad Each 100ml contains: to 18-07-2018
N-Acetylcysteine…5gm
Import in finished form from
M/s. Bruschittini s.r.l., Italy
2. M/s. Medipak 010616 Nephrosteril 21-03-1980 w.e.f. 21-03-2010

Limited, Lahore 1 Litre contains: to 20-03-2015
L-Isaleucine…5.1g
L-Leucine…10.3g
L-Lysine Monoacetate…10.1g
L-Methionine…2.80gm
L-Lysine….7.1g
Acetyl Cysteine…0.50g
L-Cysteine…0.37g
L-Phenylalanine….3.80g
L-Threonine…4.80g
L-Trytophane…1.90g
L-Valine…6.20g
Arginine….4.90g
L-Histidine…4.30g
Aminoacetic Acid…3.20g
L-Alanine….6.30g
L-Proline…4.30g
L-Serine…4.50g
L-Malic Acid….1.50g
Glacial Acetic Acid…1.38g
Water for Inj. q.s. 1201
KJ/L=280Kcal/L
Content of Amino
Acid=70g/litre
Product is imported from
Fresenius Kabi Austria
GmbH Hafnertrasse 36,A-
8055 Garz,Austria
Decision: Registration Board acceded to request of the firm of the products at Sr. No. 01 &02
and decided to grant/regularize the renewal mentioned against each in column VI
subject to the prevailing Import Policy for Finished Drugs.
Case No. 51 Case of M/s. Libra (Pvt) Ltd., Peshawar Received Under SRO No.1005
(I)/2017.
It is submitted that M/s. Libra (Pvt) Ltd., Peshawar has applied under SRO
1005(I)/2017 for regularisation of renewal of year 2014, however renewal of registration of year
2009 was received after 60 days of expiry of registration. Detail of the case is given as under:
Sr. Reg. No. Product Name Along Initial Reg. Application Remarks
No with Composition Date Receiving Date
1 025478 Chixicol Syrup 31-12-1999 (Due Date: Firm was asked to provide
Each 5ml contains:- 30-12-2014) evidence of renewal of 2009
Promethazine HCI …. Rs. 30,000/- and the firm provide copy of
renewal application of year
1.5mg Applied under
2009 which was received on
Pholcodine …. 1.5mg SRO 1005(I)/ 15-09-2010 i.e. after sixty
2017 on (60) days of expiry of
30-11-2017 Registration.
Decision: Registration Board decided to defer the case for opinion from Legal Affair
Division.
Case No. 52 Case of M/s. Spadix Pharmaceuticals, Islamabad Received Under SRO
No.1005 (I)/2017.
It is submitted that However Central Licensing in its 255th meeting held on

16-17 June, 2017 cancelled the license of firm and in response to this decision Registration Board
in its 276th meeting held on 22-25 November, 2017 decided as under:
Decision: Registration Board observed that as a result of declaration of Drug

Manufacturing License invalid / surrended / cancelled by Central Licensing
Board, registration of drugs also become invalid and thus cancellation letters
shall be issued accordingly.
Accordingly, cancellation of registration letter was issued on 30th March, 2018 by
Registration Section (R-III). Furthermore, M/s. Spadix Pharmaceuticals, Islamabad has applied
for regularization of renewal of registration under SRO 1005(I)/2017 on 04-12-2017 for their
following products
Sr.no. Reg.no. Product Name
1 062923 Zodex Injection
2 062939 Dexime Capsules
3 062920 Nodex Injection
4 062915 Dexpime Injection
5 062916 Dexpime Injection 1gm
6 062935 Dexef Capsules
7 062933 Dexef Dry Suspension
8 062924 Zodex Injection
9 062938 Dexime Suspension
11 062934 Dexef Dry Suspension
13 062937 Dexime Suspension
While inadvertently RRR Section communicate the shortcoming observed in the renewal
application submitted by the firm under SRO 1005 (I)/2017 and placed the case for the
information of Registration Board in its 278th meeting held on 29-31 January, 2018.
Decision: Registration Board did not acced to the above case as Drug Manufacturing
License of firm has already been cancelled and subsequently all registered
products have also been cancelled.
Case No. 53 Cases Received in Year 2018

Registration Board in 276th meeting approved the SOP‘s for the submission of
renewal applications for locally manufactured drugs (Human & Veterinary) and finished drugs for
import (Human & Veterinary) and approved the criteria for consideration of renewal applications.
The RRR-Section of PE&R Division has evaluated the cases received in January,
2018. The cases which has not been submitted in accordance with approved SOP‘s, shortcoming
letter has been communicated to the firms for completion of their documents.
A. Fresh Renewal Application Year 2018
The cases were received in January, 2018 but not accordance with the
SOP‘s approved in 276th Meeting of Registration Board, shortcoming letter has been
communicated. Following firm fulfil the requirements
a) M/s. Genome Pharmaceuticals (Pvt) Ltd., Haripur.
S. Reg. No. Product Name Initial date Application Validity
No. of Receiving
Registration date
1. 002814- Ex Cofic 400mg Capsule 23-05-1995 Due date w.e.f.08-02-2018 to
Each capsule contains:- Transfer of 07/02/2018 07-02-2023
Cefixime (as Trihydrate) registration Application
…. 400mg dated received date
08-02-2013
2. 002815- Ex Cofic 200mg Dry Powder -do- Due date w.e.f.08-02-2018 to

Suspension 07/02/2018 07-02-2023
Each 5ml contains:- Application
Cefixime (as Trihydrate) … received date
200mg 22-01-2018
3. 002816- Ex Cofic 100 mg Dry Powder -do- Due date w.e.f.08-02-2018 to

Suspension 07/02/2018 07-02-2023
Each 5ml contains Application
Cefixime (as Trihydrate) … received date
100mg 22-01-2018
4. 004011- Ex Clorid 5mg Tablet 08-02-2013 Due date w.e.f.08-02-2018 to

Each film coated contains: - 07/02/2018 07-02-2023
Rosuvastatin (as calcium) Application
… 5mg received date
22-01-2018
5. 004012- Ex Clorid 10mg Tablet 08-02-2013 Due date w.e.f.08-02-2018 to

Each film coated tablet 07/02/2018 07-02-2023
contains: _ Application
Rosuvastatin (as calcium) received date
… 10mg 22-01-2018
Decision: Registration Board acceded to request of the firm of products at Sr. No. 01-05 and
decided to grant renewal (s) mentioned against each in column V.
b) M/s. Highnoon Laboratories Ltd., Lahore
6. 048917 Hilin Capsule 50mg 04-02-2008 Due date w.e.f.04-02-2018 to

Each capsule contains 03/02/2018 03-02-2023
Pregabalin … 50mg Application
received date
11-01-2018
7. 048917 Hilin Capsule 100mg -do- Due date w.e.f.04-02-2018 to
Each capsule contains: - 03/02/2018 03-02-2023
Pregabalin … 100mg Application
received date
11-01-2018
8. 048959 Pyctomet Tablet 09-02-2008 08-02-2018 w.e.f.09-02-2018 to
Each tablet contains: _ Application 08-02-2023
Pioglitazone as Hcl … received date
15mg 11-01-2018
Metformin Hcl … 500mg
Decision: Registration Board acceded to request of the firm of products at Sr. No. 06-08
and decided to grant renewal (s) mentioned against each in column V.
Case No.54 Applications Received with Shortcomings
This section apprised the Board that Directorate of (PE&R) is dealing with number
of applications submitted for renewal of drugs which are incomplete or have shortcoming
especially with reference to the submitted prescribed renewal fees.The following applications for
renewal of drugs are submitted on Form 5-B after the expiry of validity of the certificate of
registration but within sixty days after validity of certificate of registration. The applications for
renewal are incomplete with reference to renewal application fee or having some other deficiency.
RULE 27 Drug (Licensing, Registering & Advertising) Rules, 1976 (Duration of certificate
of registration). A certificate of registration under this chapter, [shall unless earlier suspended
or cancelled, be in force for a period of five years from the date of [Registration of the drug] and
may thereafter be renewed for period not exceeding five years and a certificate to this effect shall
be issued within one month] at a time.
Provided that an application for the renewal of registration shall not be entertained unless it has
been made within sixty days after the expiry of the registration and when an application has
been made aforesaid the registration shall subject to the orders passed on the application for the
renewal continue in force for the next period of five years and a certificate to this effect shall be
issued within one month].
Provided further that in case of an imported drug, the renewal may be granted and a renewal
certificate shall be issued, if in the opinion of the Registration Board it is necessary to do so in the
public interest.
Following cases are placed below for consideration of the Registration Board.
i) Cases Received After Expiry of Registration, But Within 60 Days Under (L, R&A) Rules
1976.
a) M/s. Cirin Pharmaceuticals (Pvt.) Ltd., Hattar
Sr. Reg. No. Product Name Initial date of Application Receiving date
No. Registration
1. 045905 Transtat Capsule 250mg 03-02-2007 Due date (02-02-2017)
Each capsule contains: Renewal Application of year
Tranexamic 2017 is received within time
Acid….250mg i.e. on 26-01-2017.However
last renewal of year 2012 was
received late but within 60
days along with fee of
Rs.4,000/-i.e. on 21-02-2012
so firm submitted remaining
fee of Rs.16,000/- on 29-11-
2017
2. 045906 Moximax Infusion -do- -do-
250ml
Each Infusion (250ml)
contains:
Moxifloxacin as
HCl…400mg
3. 045909 Transtat Capsule 500mg -do- -do-
Each capsule contains:
Tranexamic
Acid….500mg
4. 045910 Moximax Tablet 400mg -do- -do-
Moxifloxacin as
HCl…400mg
5. 045911 Novocef vial 1gm 03-02-2007 -do-
Injection Change of brand
Each vial contains: name dated
Cefoperazone (as 19-12-2007
Sodium)…500mg
Sulbactam
Sodium…500mg
6. 045912 Tazopip Injection 03-02-2007 -do-
Each vial contains:
Piperacillin (as
Sodium)….4gm
Tazobactam (as Sodium)
7. 045913 Plasmocide-Plus Tablet -do- -do-
Artemether INN…40mg
Lumefantrine
INN…240mg
Decision: Registration Board regularized the renewal of products mentioned above for
the year 2012 w.e.f. 03-02-2012 to 02-02-2017 and further renewed the
products w.e.f. 03-02-2017 to 02-02-2022.
ii) Cases for Imported Pellets.
a) M/s. Cirin Pharmaceuticals (Pvt.) Ltd., Hattar
Case is referred by R-IV Section.
Sr. Initial date of

Reg. No. Product Name Application Receiving date
No. Registration
1 022533 Protopin Capsule 26-11-1998 Due date (25-11-2013)
Each film coated capsule Fee of Rs. 10,000/- deposited
contains: on19-11-201(photocopy
Lansoprazole…30mg verified by concerned bank).
As these are imported pellets
from M/S Dr. Reddy’s
Laboratories Ltd., 60-1-27
Ameerpet Hyderabad 500
016 India. So, remaining fee
of Rs.10,000/- is deposited
on 23-08-2017
2 022534 Protopin HA Capsule -do- -do-
Each film coated capsule
contains:
Lansoprazole…15mg
Decision: Registration Board acceded to request of firm and decided to grant renewal of
products w.e.f. 26-11-2013 to 25-11-2018.
Item No. IV Division of Biological Evaluation and Research
Item Details of application No. of

No. Cases
1. Local Human Biologicals 1
2. Imported Human Biologicals from Reference Countries 4
3. Imported Human Biologicals from Non-Reference Countries 2
4. Miscellaneous/ Deferred cases 23
Total 30
Additional Agenda 4
Sr. Assistant Director Designated No. No. of Cases

No.
1. Mr. Khurram Khalid AD-I 08
2. Mr. M. Sarfraz Nawaz AD-II 22
AD-II
Case No 1 Local Human Biologicals

Name and address of product M/s National Institute of Health, Islamabad
manufacturer
Name and address of bulk M/s Liaoning Cheng da Biotechnology Co., Ltd.
Manufacturer No.1, Xinfang Street, Hunnan New District, Shengyang,
China.
(Ready-to-fill bulk)
Brand Name +Dosage Form + Rabies Vaccine (Vero Cell) Human use
Strength 0.5ml/vial
Type of Form, Diary No. Date of Form-5,

R& I & fee Dy No. 6165(R&I) Date: 20-02-2018
Composition Each single dose contains:

Protective activity of Rabies Antigen ≥ 2.5IU*
(Rabies virus – L. Pasteur PV-2061 propagated on Vero cell
and activated with β –propiolactone)
Pharmacological Group Vaccine
Finished Product Specification Pharmacopeial
Shelf Life 18 Months
Document Details 1. CoPP No. 2018018 dated 05-03-2018

2. GMP Certificate No. LN 20170037 dated 05-03-2018.
3. FSC No. 2017024 dated 05-03-2018.
Pack size & Demanded Price 1s‘ Rs. 500/-per dose
International Availability China
Products already registered in Verorab

Pakistan Rabipur
Remarks of the evaluator i.

i. NIH submitted clinical trial data of finished dosage
form (vaccine) manufactured by applied bulk concentrate.
ii. ii. Sole agency in the name of M/s Hospital Services &
Sales (HSS) and they will supply the bulk concentrate to
NIH.It is also mentioned in Sole agency letter NIH also
authorized to submit the above-mentioned product in DRAP
for registration.
iii. iii. M/s Hospital Services & Sales (HSS) will supply the bulk
concentrate imported from M/s Liaoning Cheng da
Biotechnology Co., Ltd. No.1, Xinfang Street, Hunnan New
District, Shengyang, China. to NIH for rabies vaccine.
Decision: Registration Board Approved Rabies Vaccine (Vero Cell) Human use 0.5ml/vial
for registration.
Case No. 2 Imported Human Biologicals from Reference Countries

1. Name and address of M/s Roche Pakistan Limited
Importer 37-C, Block-6, P.E.C.H.S, P.O Box 20021, Karachi
DSL no. 0268
Valid till 27-12-2018
Name and address of Marketing authorization holder
Manufacturer Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn
Garden City AL7 1TW, United Kindom.
Manufacturer
M/s Chugai Pharma Manufacturing Co., Ltd,
(CPMC) 16-3, KiyoharaKogyodanchi Utsunomiya City, Tochigi,
321-3231, Japan
Applicant for Certificate (Country from where drug proposed
to be imported)
F.Hoffmann-La Roche Ltd., Grenzacherstrasse 124, 4070 Basel,
Switzerland.
Brand Name +Dosage Hemlibra / Injection / (Emicizumab) 30mg/ml Solution for
Form + Strength Injection
Type of Form, Form 5-A

Diary No. Date of R& I 23939/2017
& fee PKR. 50,000/- dated 08-12-2017.
Composition Each ml of injection contains:
Emicizumab……….30mg at concentration of 30mg/ml
Pharmacological Group Antihaemorrhagics;
Bispecific antibodies;
Monoclonal antibodies;
Recombinant proteins
Finished Product Innovator
Specification
Shelf Life 2 Years
Document Details Valid legalized CoPP No. 04/18/118035 dated 07-03-2018 issued by
EMA.
Pack size & Demanded 1‘s, N/A
Price
International Availability UK
Products already N/A

registered in Pakistan
Remarks of the evaluator

Decision: Keeping in view valid legalized CoPP and approval of EMA (Reference Regulatory
Authority/country); Registration Board approved the product subject to price fixation by the
Federal Government and compliance of current Import Policy for Finished Drugs.

DSL No. 0268

Validity 27-12-2018
Manufacturer
321-3231, Japan
to be imported)
Switzerland.
Brand Name +Dosage Hemlibra / Injection /(Emicizumab) 60mg/0.4ml Solution for
Diary No. Date of R& I Form 5-A

& fee 23938/2017
PKR. 50,000/- dated 08-12-2017.
Composition Each 0.4ml of injection contains:
Specification
Shelf Life 2 years
EMA.
Price


DSL No. 0268
Validity 27-12-2018
Manufacturer
321-3231, Japan
to be imported)
Switzerland.
Brand Name +Dosage Hemlibra /Injection/(Emicizumab) 105mg/0.7ml Solution for
Type of form Form 5-A

23940/2017
Diary No. Date of R& I PKR. 50,000/- dated 08-12-2017.
& fee
Composition Each 0.7ml of injection contains:

Specification
Shelf Life 2 years
EMA.
Price


DSL No. 0268
Validity 27-12- 2018
Manufacturer
321-3231, Japan
to be imported)
Switzerland.
Brand Name +Dosage Hemlibra
(Emicizumab) 150mg/ml Solution for Injection
Type of form Form 5-A
Diary No. Date of R& I 23941/2017
& fee PKR. 50,000/- dated 08-12-2017.
Composition Each ml of injection contains:
Type of Form Form-5A dated 08-12-2017.

Specification
Shelf Life 2 years
EMA.
Price


Case No.3 Imported Human Biologicals from Non-Reference Countries
1. Name of Importer Helix Pharma (Pvt.) Ltd.,
Hakimsons House, A/56, S.I.T.E, Manghopir Road, Karachi-75700
Name of M/s Intas Pharmaceutics Limited Plot No. 423/P/A, Sarkhej-Bavla
Manufacturer Highway, Village: Moraiya, Taluka: Sanand, Ahmedabad-382 213,
Gujarat, India
Brand Name +Dosage Ximab/Mab X 100mg/10ml
Form + Strength Concentrate for solution for Infusion
Composition Each 10ml single use vial contains:
Rituximab 100mg (10mg/ml)
Finished product In house
specifications
Pharmacological Monoclonal antibody
Group
Shelf life 2 years at 2-80C
Approval status in Mabthera of USA
Reference countries
International INDIA
availability NEPAL
Bangladesh
Products already Mabthera of Roche Pakistan Ltd.
Type of Form Form 5-A,
Dy No & Date of Dy. No. 3297(R&I) Date: 03-03-2017
application, Rs. 100,000/- Date: 02-03-2017
Fee submitted
Demanded Price / 34500/2 s‘ vials
Pack size
General CoPP, Certificate No. MFG/WHO-COPP/INTAS/2016/141555
documentation Valid till 18-09-2018
Distribution & marketing agreement.
Remarks of Evaluator The firm submitted stability study for Rituximab 100mg/10ml as per
following detail:
i. 3 Batches of stability study for clinical trial batches at 2-
80C.
ii. 3 Batches of stability study for Clinical trial batches at
250C.
2. Name of Importer Helix Pharma (Pvt.) Ltd.,
Hakimsons House, A/56, S.I.T.E, Manghopir Road, Karachi-75700
Name of M/s Intas Pharmaceutics Limited Plot No. 423/P/A, Sarkhej-Bavla

Manufacturer Highway, Village: Moraiya, Taluka: Sanand, Ahmedabad-382 213,
Gujarat, India
Brand Name +Dosage Ximab/Mab X 500mg/50ml
Form + Strength Concentrate for solution for Infusion
Composition Each 50ml single use vial contains:
Rituximab 500mg (10mg/ml)
Finished product In house
specifications
Pharmacological Monoclonal antibody
Group
Shelf life 2 years at 2-80C
Approval status in Mabthera of USA
Reference countries
International INDIA
availability NEPAL
Bangladesh
Products already Mabthera of Roche Pakistan Ltd.
Type of Form Form 5-A,
Dy No & Date of Dy. No. 3296(R&I) Date: 03-03-2017
application, Rs. 100,000/- Date: 02-03-2017
Fee submitted
Demanded Price / Rs. 85,500/1‘s vials
Pack size
General CoPP, Certificate No. MFG/WHO-COPP/INTAS/2016/141557
documentation Valid till 18-09-2018
Distribution & marketing agreement.
Remarks of Evaluator Firm submit stability study for Rituximab 500mg/50ml as per
following detail:
i. 1 Batch of annual stability study of 36Months at 2-80C.
ii. 1 Batch of annual stability study of 24 Months at 2-80C.
iii. 3 Batches of stability study for validation batches at 2-80C.
iv. 3 Batches of stability study for Clinical trial batches at
250C.
The firm has submitted the bio-similarity data as per following detail:
WHO Biosimilarity Data Submitted by the firm
guidelines
Quality Comparison Comparative Structure elucidation
Physicochemical Primary Structure
characterization i. Peptide Map
ii. Mass Spectroscopy
Secondary Structure
i. Circular Dichroism
ii. UV Spectroscopy
Tertiary Structure
Fluorescence
Purity/Impurity Analysis
i. Size Exclusion High Performance Liquid
Chromatography (SE-HPLC)
ii. SDS-PAGE (Reduced)
iii. Cation-Exchange High Performance Liquid
Chromatography (CEX-HPLC)
Biological Activity Complement Dependent Cytotoxicity assay

Immunochemical properties ELISA test
Impurities The potential process related impurities include:
i. Host-related proteins
ii. Host-derived residual DNA
iii. Endotoxin
iv. Residual protein
The potential product-related impurities include
i. Aggregates (High Molecular Weight Impurities)

ii. Related impurities
Stability Studies Stability studies are provided.
Non-clinical Studies Pre-clinical Studies
i. In-vitro Studies In-vitro Studies
ii. In-vivo Studies Comparative Primary Pharmacodynamics
i. In Vitro Efficacy Testing
ii. Complement Dependent Cytotoxic Assay
iii. Antibody-Dependent Cell-Mediated Cytotoxicity
In-vivo Studies
Toxicology studies
i) Single Dose Toxicity
a. Single Dose Toxicity Study of Intas Rituximab in Swiss
Albino Mice Following Intravenous Administration
b. Single Dose Toxicity Study of Intas Rituximab in Wistar Rat
Following Intravenous Administration
ii) Repeated Dose Toxicity
a. 4-week Sub-acute Intravenous Toxicity Study of Intas
Rituximab in Wistar Rats with 14 days Recovery Period.
b. 4-week Sub-acute Intravenous Toxicity Study of Intas
Rituximab in New Zealand White Rabbits with 14 days
Reversal Period.
iii) Local Tolerance
a. Skin Sensitization Study (GPMT) of Intas Rituximab in
Guinea Pigs.
b. Acute Dermal Irritation Test of Intas Rituximab in New
Zealand White Rabbits
Clinical Studies A prospective, comparative, randomized, multicenteric Phase III
study of rituximab (Intas) and MabThera® (Roche) in patients
with Non-Hodgkin‘s Lymphoma (NHL) (n=101, 17patients
discontinued from study 84 patients complete the study).
Decision: Registration Board deferred the applications for submission of real time and
accelerated stability data of three (03) commercial batches.
Case No.4 Miscellaneous/ Deferred cases of previous meeting
a. Update in Prescribing Information of already approved human biological Gazyva

(Reg. No. 087084) applied by M/s Roche Pakistan Limited, Karachi.
M/s Roche Pakistan Limited, Karachi applied for the approval of new indication of their
already registered human biological Gazyva (Reg. No. 087084) as per following details:
Reg. No. & Brand Name & Already approved New applied indication
Date of Composition indication
registration
087084 Gazyva Chronic Chronic Lymphocytic Leukemia
20-12-2017 Concentrate for Lymphocytic Gazyva in combination with
solution for Leukemia chlorambucil is indicated for the
infusion Gazyva in treatment of adult patients with
(Obinutuzumab combination with previously untreated chronic
1000mg) chlorambucil is lymphocytic leukemia (CLL) and
indicated for the with comorbidities making them
Each 40ml vial of treatment of patients unsuitable for full-dose fludarabine
concentrate with previously based therapy.
contains: untreated chronic Follicular Lymphoma
Obinutuzumab..…. lymphocytic Gazyva in combination with
..1000mg(25mg/ml) leukemia (CLL) and chemotherapy, followed by Gazyva
with comorbidities maintenance therapy in patients
making them achieving a response, is indicated
unsuitable for full- for the treatment of patients with
dose fludarabine previously untreated advanced
based therapy. follicular lymphoma.
Gazyva in combination with
bendamustine, followed by Gazyva
maintenance is indicated for the
treatment of patients with follicular
lymphoma (FL) who did not
respond to, or who progressed
during or upto 6 months after
treatment with rituximab or a
Rituximab-containing regimen.
The firm has submitted following documents:

a. Application for approval of new indication.
b. Fee Challan of Rs. 5000/-
c. Copy of initial registration letter.
d. Difference between existing and proposed information in tabulated form.
e. Justification of proposed changes.
f. Valid legalized CoPP No. 01/18/115922 dated 09-01-2018 issued by EMA indicating
new indication.
g. Copy of proposed PIL.
h. Clinical over view and summary of clinical efficacy for new indication.
Registration Board in its 276th meeting approved following SOPs for the change in prescribing
information of imported biological drugs:
c. Difference between existing and proposed information in tabulated form.
d. Justification of proposed changes.
e. Reference of prescribing information of brand leader (for me too products).
f. Legalized approval from regulatory agency/authority from country of origin.
g. Copy of label outer pack in case of changes in indication/ dose/ administration etc.
Decision: Keeping in view valid legalized CoPP and approval of EMA (Reference
Regulatory Authority/country); Registration Board approved the above update in
prescribing information of already approved human biological Gazyva (Reg. No.
087084).
b. Product name change and Exemption of inspection applied by M/s Getz Pharma
(Pvt.) Limited, Karachi for their already approved products Travia.
Following products of M/s Getz Pharma, Karachi were approved in 278th meeting of
Registration Board as per following details:
1. Name and address of Importer M/s Getz Pharma (Pvt.) Ltd, 29-30, Sector-27, Korangi
Industrial area, Karachi.
Name and address of M/s Biocon Limited, Special Economic Zone, Plot Nos. 2,3,4
Manufacturer & 5 Phase-IV, Bommasandra-Jigani Link Road,
Bommasandra Post,Bangalore-560099,India
Brand Name +Dosage Form + TRAVIA 150MG (SINGLE USE VIAL)
Strength Trastuzumab for Injection (rDNA Origin) 150mg/vial
Diary No. Date of R& I & fee Dy No. 646/2017(R&I) Date: 17-03-2017
Rs.100,000/- Date: 12-03-2017
Trastuzumab(rDNA Origin)…150mg
Pharmacological Group Anti-neoplastic
Type of Form Form-5A
Finished Product Specification Manufacturer‘s Specs.
Shelf Life 4 years
Document Details CoPP No. DCD/CR-1849/Spl.Cell-I/2015-16

dated 07-12-2016
Pack size & Demanded Price Pack Size: 1‘s vial(150mg)/ Rs.50,000
International Availability Herceptin by Roche Products Limited, UK.
Products already registered in New Strength.

Pakistan
Remarks of the evaluator 1. Product is registered with the name of CanMabTM 150 in
country of origin with product license no.:
KTK/28D/7/2006 dated 28-04-2006 Permission letter no.
DCD/CR-634/MFG/13-14 Dated 10-04-2014.
2. Brand name applied by the firm on Form-5A is Travia while
as per submitted CoPP Brand Name is CanMab.
3. Letter of Authorization is for Trastuzumab and not for
applied brand name.
Brand Name +Dosage Form + TRAVIA 440MG VIAL (Multiple use vial) Combipack
Rs.100,000/- Date: 12-01-2017
Shelf Life 4 years

dated 07-12-2016
Pack size & Demanded Price Pack Size: 1s vial(440mg)/ Rs.100,000
International Availability Herceptin by Genetech Inc., USA
Products already registered in Herceptin of Roche Pakistan Limited.

Pakistan
country of origin with product license no.:
DCD/CR-634/MFG/13-14 Dated 10-04-2014.
2. Brand name applied by the firm on Form-5A is Travia
while as per submitted CoPP Brand Name is CanMab.
applied brand name.
Brand Name +Dosage Form + TRAVIA 150 MG VIAL (Multiple use vial) Combipack
Rs.100,000/- Date: 23-02-2017
Shelf Life 4 years

dated 07-12-2016
Pack size & Demanded Price Pack Size: 1s vial(150mg)/ Rs.50,000
International Availability Herceptin by Roche Products Limited, UK.
Products already registered in New Strength.
Pakistan
country of origin with product license no.
DCD/CR-634/MFG/13-14 Dated 10-04-2014.
2. Brand name applied by the firm on Form-5A is Travia
while as per submitted CoPP Brand Name is CanMab.
applied brand name.
Brand Name +Dosage Form + BACTERIOSTATIC WATER FOR INJECTION
Strength 15ML VIAL
Rs.100,000/- Date: 02-06-2017
Bacteriostatic Water for Injection…....10ml
Finished Product Specification USP Specs
Shelf Life 02 years.
dated 07-12-2016
Pack size & Demanded Price Pack Size: 1s vial(10ml)/ Diluent in combipack.
Remarks of the evaluator  The firm has submitted that the diluent will be used in
combipacks of Travia 440mg and 150mg (Multiple use
vial).
Decision of 278th meeting of RB:
Keeping in view the opinion of Legal Affairs Division, biosimilarity data and submitted CoPP
indicating that the products are available for sale in the country of origin, Registration Board
approved the above products as per valid legalized CoPP subject to price fixation by Federal
Government and compliance of current Import Policy for Finished drugs.
Now the firm submitted that in accordance with the Import Policy for Medicines issued by DRAP
(Reg-I) inspection of manufacturer abroad needs to be carried out by panel of inspectors
constituted by DRAP. Furthermore, manufacturer abroad inspection may be exempted if the
product is approved by regulatory authorities as mentioned in the Import Policy for Medicines
notified by DRAP.
They further submitted that manufacturing facility of M/s Biocon Limited, India has been
inspected and approved by USFDA for Trastuzumab injection. Moreover, in 278th Registration
Board meeting dated 2-31 January, 2018 DRAP has placed the application of M/s AGP with the
brand name of Hertraz (Trastuzumab) manufactured at M/s Biocon Limited, India before the
Registration Board for discussion and decision for grant of inspection exemption, based on the
submission of evidence indication that USFDA has inspected and approved the facility of M/s
Biocon Limited, India for manufacturing of Trastuzumab Injection. The firm requested that on the
basis of inspection and approval of manufacturing facility of M/s Biocon Limited, India by
USFDA and consideration of M/s AGP application for inspection exemption in 278th meeting as
the manufacturing facility is same. The firm requested to waive the inspection of manufacturing
facility of M/s Biocon Limited, India.
In this context, it is submitted that Registration Board in its 278th meeting exempted the
inspection of manufacturer abroad of M/s Biocon Limited, Special Economic Zone, Plot No. 2, 3,
4& 5, Phase IV, Bommasandra-Jigani link road, Bommasandra post, Bengaluru, Karnataka
560099, India and decided as follows:
“Keeping in view the USFDA BLA approval of Ogivri 420mg Vial (Trastuzumab-dkst) available
at www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761074 Orig1s000ltr.pdf (accessed
on 30-01-2018) wherein it is mentioned for Ogivri 420mg Vial (Trastuzumab-dkst) that the final
formulated product and Bacteriostatic water for injection USP will be manufactured, filled,
labeled and packaged at M/s Biocon Limited (FEI: 3003981475) in Bangalore, Karnataka, India
which is the same site where Hertraz 440mg and Hertraz 150mg are manufactured. Therefore,
Registration Board exempted the inspection of M/s Biocon Limited, Special Economic Zone, Plot
No. 2, 3, 4 & 5, Phase IV, Bommasandra-Jigani link road, Bommasandra post, Bengaluru,
Karnataka 560099, India (manufacturing facility of Hertraz 440mg and Hertraz 150mg) as per
current Import Policy for Finished drugs and as per valid legalized CoPP.”
i. As the aforementioned exemption was granted for the same kind of products i.e
Trastuzumab of M/s AGP, Karachi, therefore the inspection of M/s Biocon Limited, India for
Trastuzumab of M/s Getz Pharma (Pvt.) Ltd., Karachi may also be considered by the Board
please.
ii. Furthermore firm has requested to issue registration letter of their approved product with
brand name ―Trastuget‖ instead TRAVIA.
Decision: Keeping in view the USFDA BLA approval of Ogivri 420mg Vial
(Trastuzumab-dkst) available at
www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761074 Orig1s000ltr.pdf
(accessed on 30-01-2018) wherein it is mentioned for Ogivri 420mg Vial
(Trastuzumab-dkst) that the final formulated product and Bacteriostatic
water for injection USP will be manufactured, filled, labeled and packaged at
M/s Biocon Limited (FEI: 3003981475) in Bangalore, Karnataka, India which
is the same site where Travia 440mg (Multiple use vial), Travia 150mg (Single
use vial), Travia 150mg (Multiple use vial) and Bacteriostatic water for
injection are manufactured. Therefore, Registration Board exempted the
inspection of M/s Biocon Limited, Special Economic Zone, Plot No. 2, 3, 4 & 5,
Phase IV, Bommasandra-Jigani link road, Bommasandra post, Bengaluru,
Karnataka 560099, India (manufacturing facility of Travia 440mg, Travia
150mg and Bacteriostatic water for injection) as per current Import Policy for
Finished drugs and as per valid legalized CoPP.
Registration Board advised DBER that for the approval of change in brand
name Chairman Registration Board is authorized therefore the case may be
processed accordingly.
c. Rilast applied by M/s Genix Pharma Karachi.
Following applications of M/s Genix Pharma, Karachi were considered in 278th meeting of
Registration Board and deferred for submission of valid legalized CoPP or GMP & FSC as per
following details:
Sr. Name of Brand Name & Type of Form Document details

No. Manufacturer Composition Dy No & Date (CoPP)
of application Reference agencies
Fee submitted availability
Pack size/ Locally registered
Demanded product
Price
1. M/s Hetero Rilast100 Form 5-A Legalized valid
Biopharma Limited (Rituximab100mg/10ml Dy No. CoPP No:
Sy. No.458(part), Concentrate for solution for 618/2016(R&I) DI/SAN/KTR/CoPP
TSIIC-Formulation injection in single use vial) 27-04-2016 /22.08.2015-13
SEZ, Polepally 453-ADC(BD) dated 22-08-2015
(Village), Jadcherla Each 10ml vial contains 27-04-2016
(Mandal), Rituximab(rDNA origin) Rs.100,000/- MabThera 100mg
Mahaboobnagar In-house……100mg 18-04-2016 of Roche products
(District)—509 301, Pack of 1‘s/ (UK)
Telangana, India. Anti-neoplastic Rs. 17,250/-
Ristova of Roche
In-house Specs Pakistan Ltd.
Shelf Life: 2 years
2. Rilast 500 (Rituximab Form 5-A Legalized valid

500mg/50ml Concentrate Dy No. CoPP No:
for solution for injection in
619/2016(R&I) DI/SAN/KTR/CoPP
single use vial) 27-04-2016 /22.08.2015-11
452-ADC(BD) dated 22-08-2015
Each 50 ml vial contains 27-04-2016
Rituximab(rDNA origin) In- Rs.100,000/- MabThera 500mg
house……500mg 18-04-2016 of Roche products
Pack of 1‘s/ (UK)
Anti neoplastic Rs. 85,500/-
Ristova of Roche
In-house Specs Pakistan Ltd.
Shelf Life: 2 years
Case History
In 263rdRegistration Board meeting the case was initially considered and Board:“Deferred due to
paucity of time”
In 264thMeeting:The case was again placed before the board in 264th meeting and Board “Deferred
the product for evaluation of biosimilarity data”
Remarks of Division:
The firm has submitted the biosimilarity data which requires in-depth evaluation by the
Division and the expert if required. Further the Innovator has already gone to court against the
previous Board decision to consider similar molecule and has obtained a stay order against the
issuance of registration letter to M/s Macter Karachi.
The firm has submitted bio-similarity as per following details:

WHO Biosimilarity Data Submitted by the firm
Guidelines
Quality Comparison i. Peptide Mapping
1. Physicochemica For identity testing targeting the primary sequence.
l ii. Concentration by Absorbance 280 method
Characterization To determine the concentration of the sample.
iii. UV-Absorption Spectra
To determine and compare the UV absorption spectra of product with
that of reference.
iv. Sodium dodecyl sulphate polyacrylamide gel electrophoresis
(Non-reducing and Reducing)
To determine the purity of product with respect to molecular weight
impurities.
v. Size Exclusion Chromatography (SEC-HPLC)
To determine the product aggregates / multimers.
vi. Cation Exchange Chromatography (CEX)
For purity determination in terms of charge variants.
vii. Reduced reverse phase chromatography (RPC)
For purity determination in terms of hydrophobic related substances
including light and heavy chain
viii. Capillary Electrophoresis SDS-PAGE (Reducing)
For quantitation of non-glycosylated heavy chain and relative
percentages of light and heavy chains
ix. Capillary Electrophoresis SDS-PAGE (Non-Reducing)
For quantitative determination of the degradation products (LMW
impurities).
x. Capillary IEF
For Isoelectric point determination
xi. Intrinsic Fluorescence
For tertiary structure elucidation.
xii. Extrinsic Fluorescence
For tertiary structure elucidation
xiii. Hydrophilic (HILIC) Chromatography
For Glycan forms determination.
xiv. Bioassay (CDC)
For relative biological efficacy.
2. Biological Activity Comparative In vitro Biological activity is provided.
3. Immunochemical i) Receptor Binding Activity
properties ELISA test
ii) Affinity Analysis
4. Impurities i. RPC method was performed to check the purity in terms of
hydrophobic related impurities.
ii. CE-SDS PAGE was performed at both reducing and non-reducing
condition (Low molecular weight impurities).
5. Stability Studies Stability study provided
Non-clinical Pre-clinical Studies
Comparison in-vivo Studies
i. In-vitro Studies If the quality biosimilar comparability exercise and the nonclinical
ii. In-vivo Studies in vitro studies are considered satisfactory and no issues are
a. Biological/ identified which would block direct entrance into humans, an in
Pharmacodyna vivo animal study may not be considered necessary. (Guidelines on
mic activity. evaluation of monoclonal antibodies as similar biotherapeutic
b. Non- clinical products (SBPs) (World Health Organization 2016).
toxicity as iv) Safety Pharmacology
determined in Toxicology
one repeat dose a. Single Dose Toxicity
toxicity study. b. Repeated Dose Toxicity
c. Local Tolerance
6. Clinical A Randomized, Multiple-dose, Multicenter, Comparative Parallel Study to
Comparison Evaluate the Efficacy, Safety and Pharmacokinetic Characteristics of
Intravenous Infusion of Rituximab (Hetero) and Reference Medicinal Product
(Rituximab, Roche) in Indian Patients of Non-Hodgkin's Lymphoma (Sample
size of 52 per arm 104 completers for two arms was required for this study
i. An Observational, Non-Interventional, Multi-Centric Postmarketing
Surveillance Study Evaluating The Safety and Tolerability of The
Labeled Usage Of Hetero - Rituximab In Prescribed Patients.
ii. Published study
(http://adisinsight.springer.com/trials/700237414)
th
Decision of 278 meeting:Registration Board deferred the product for submission of valid legalized
CoPP or GMP & FSC.
Remarks of evaluator:
Now the firm has submitted a valid legalized CoPPs vide no. 11595/E(K)/TS/2017 dated 21-10-2017
valid till 21-09-2019 for Rilast 500mg and 11595/E(K)/TS/2017 dated 21-10-2017 valid till 21-09-
2019 for Rilast 100mg.
Decision: Keeping in view valid legalized CoPP; Registration Board approved the products
subject to price fixation by the Federal Government and compliance of current Import Policy
for Finished Drugs.
d. Local manufacturing of biological drugs of M/s. Macter International, Karachi.
It is submitted that following product of M/s Macter International Karachi was considered
th
in 254 meeting of Registration Board as per following detail:
Name of Brand name & Decision of 254th meeting of Registration Board

Manufacturer Composition
M/s Macter Momentum Registration Board evaluated the documentary details
International Each ml submitted by firm of manufacturing system, process,
Karachi contains: equipment and campaign manufacturing protocols with
Etanercept….2 reference to its previous decision. The Registration Board
5mg APPROVED the registration of Biological Product Etanercept
(Recombinant Human Tumor Necrosis Factor (a Receptor II
Ig G fusion protein) 25 mg lyophilized powder for injection,
as per conditions of bio comparability laid down in 246th
meeting of RB. The campaign manufacturing shall be as per
international standards and cross contamination with other
biologicals being manufactured in the same section shall be
avoided by using dedicated vessels and disposable flow path
for each product. The bulk concentrate of drug substance,
Etanercept (Recombinant Human Tumor Necrosis Factor)
shall be imported from Shanghai CP Goujian Pharmaceutical
Co. Ltd Shanghai China for further processing in to finished
product at M/s Macter Int. Ltd Karachi.
The firm has submitted the documents/data in the light of regulatory guideline for biological
products approved in 278th meeting of Registration Board as per following details:
i.
Documents required as per 278th RB decision for Biological
ii. Documents submitted by firm
Drugs (Concentrated Form/Ready to fill Form)
The firms shall provide legalized GMP certificate of i. GMP certificate of biological drug
biological drug substance manufacturer abroad (who will substance manufacturer abroad
provide concentrate / ready to fill bulk of biological drug (who will provide concentrate /
to Pakistani manufacturers for further processing) as an ready to fill bulk of biological drug
evidence that the manufacturer is an authorized to Pakistani manufacturers for
manufacturer of biological drug in the country of origin. further processing).
The firms shall provide legalized free sale i. Valid legalized CoPP from country
certificate/CoPP either from country of origin or by any of origin of finished product.
reference regulatory authority as adopted by Registration
Board of finished product as evidence that the final
product has been manufactured by same concentrate/ready
to fill bulk after submission of data to the concerned
regulatory authority.
The firm shall provide the complete Bio-similarity studies Complete Bio-similarity studies of the
of the finished product of same source (bulk concentrate finished product of same source (bulk
or ready to fill) manufactured either from country of concentrate or ready to fill)
origin or by any reference regulatory authority as adopted manufactured from country of origin.
by Registration Board to demonstrate the bio-similarity.
The firm shall provide the lot release certificate of the Lot release certificate of the finished
finished product manufactured by same bulk concentrate/ product manufactured by same bulk
ready to fill from country of export (If applicable). concentrate/ ready to fill from country
of export (Not applicable).
The firm shall provide the 6 months accelerated and real The firm provided the 6 months
time stability studies for drug substance. accelerated and real time stability
studies for drug substance.
The local manufacturer shall manufacture three trial After locally manufacturing three trial
batches of the finished biological product to finalize the batches of the finished biological
formulation and then perform analytical product to finalize the formulation,
studies(Physicochemical and biological) including protein firm submit the results of performed
content, appearance, pH, Osmolarity, composition of key analytical studies (Physicochemical
excipients including stabilizers (if formulation is same), and biological) including protein
visible/subvisible particles, identity testing to parent content, appearance, pH, Osmolarity,
molecule, purity testing, in vitro biological activity, composition of key excipients
sterility, Pyrogen content, safety, potency and toxicity including stabilizers (if formulation is
with support of iso-electro focusing data, gel same), visible/subvisible particles,
electrophoresis, Western-Blot and other analytical identity testing to parent molecule,
techniques). The firm shall submit the results for purity testing, in vitro biological
processing of registration application. activity, sterility, Pyrogen content,
safety, potency and toxicity with
support of iso-electro focusing data,
gel electrophoresis, Western-Blot and
other analytical techniques).
The manufacturer shall perform all tests locally as detailed Results of all locally performed tests
on Certificate of analysis. as detailed on Certificate of analysis.
The firm shall also provide the list of finished products Not Provided.
being manufactured from same bulk concentrate or ready
to fill form in any country of the world (if available).
The firm shall provide the agreement with the source (of Provide the agreement with the source
bulk concentrate/ready to fill) that if there shall be any (of bulk concentrate/ready to fill) that
critical change in manufacturing process, biological if there shall be any critical change in
systems used to manufacture, etc. the firm shall inform manufacturing process, biological
DRAP immediately along with relevant documents. systems used to manufacture, etc. the
firm shall inform DRAP immediately
along with relevant documents.
Regular monitoring through pharmacovigilance reporting Post marketing surveillance system.
system shall be observed through proper Recall system
pharmacovigilance cell of the manufacturer and report
will be forwarded to the National Pharmacovigilance
Centre, Division of Pharmacy Services and Biological
Division of DRAP. In case of any severe adverse event,
immediate mandatory reporting procedure shall be
followed.
The firm shall inform DRAP if there shall be any adverse Provided the undertaking and
event or ADR reporting from the country of manufacture agreement with manufacturer of
of concentrate/ready to fill bulk and finished product as concentrate/ready to fill bulk.
required vide Rules 30 of Drug (LR&A) Rule.
Bio-similarity studies of the finished product of same source (bulk concentrate or ready to
fill) manufactured from country of origin.
WHO Bio-similarity Data submitted by the firm
guidelines
Quality Comparison Physicochemical Characterization
Physicochemical i. Structure Characterization
characterization Primary Structure
Relative Molecular Weight by Electrophoresis
HPLC Peptide Mapping
Peptide Mass Mapping
N-terminal Amino Acid Sequence
ii. Secondary Structure (Far UV CD Spectrum &Near UV CD
Spectrum)
iii. Posttranslational Modification
N-glycan Analysis
Content of Sialic Acid
iv. Purity
SEC-HPLC Purity
HIC-HPLC Purity
SDS-PAGE Purity
v. Electric Charge Analysis
Biological Activity Biological activity in vitro for Yisaipu and Enbrel is tested by TNFα
neutralization killing test based on L929 cell with the active reference
produced by our company.
Immunochemical Receptor Binding Activity
properties ELISA Test
Affinity Analysis
Affinity with antigen TNF
Affinity with Fc segment key receptor
Affinity with FcRn receptor
Affinity with FcγRIa receptor
Affinity with Fc
Binding activity with complement C1q
ADCC activity
CDC activity
C-terminal lysine charge variants analysis
Impurities Purity
SEC-HPLC Purity
HIC-HPLC Purity
SDS-PAGE Purity
Stability Studies Stability studies are provided.
Non-clinical Studies Pre-clinical Studies
iii. In-vitro Pharmacology
Studies In-vitro Studies
iv. In-vivo Comparative Primary Pharmacodynamics
Studies iii. Murine L929 cells
iv. Biacore T100
Secondary Pharmacodynamics
Safety Pharmacology
Pharmacokinetics
In-vivo Studies
Toxicology studies
v) Single Dose Toxicity
vi) Repeated Dose Toxicity
vii) Local Tolerance
Clinical Studies Phase I Clinical Study
Compare the pharmacokinetic properties and tolerability of two
formulations of Etanercept in Mexican healthy volunteers to establish
biocomparability and non-biocomparability between both.
Phase II Clinical Study
i. Observe the safety and efficacy of rhTNFR: Fc (INN:
ETANERCEPT) after administration in the patients with
moderate or severe active rheumatoid arthritis (RA).‘
ii. Randomized double blind, placebo parallel control multi-
center clinical trial for the efficacy and safety of treating
ankylosing spondylitis with Yisaipu
Phase III Clinical Study
An open label, prospective, non-comparative, multicentre study to
assess the safety and efficacy of Etanercept for injection 25mg in
patients with moderate to severe active rheumatoid arthritis.
Phase IV Clinical Study
A multi-center and open study to evaluate the safety and efficacy of the
recombinant human tumor necrosis factor receptor II antibody fusion
protein for injection in the treatment of active rheumatoid arthritis
(RA).
Decision: As the firm has submitted additional data as required by the Board in 278th
meeting, thus the Board approved the applied product.
e. Enoxaparin Injections approved by Registration Board.

It is submitted that following enoxaparin containing injection were considered in different
meetings of Registration Board, details are as under:
Sr. Name of Brand Name & Form Document Decisions of RB
No Importer & Composition Dy. No & details
. Manufacturer Date
Price and
Pack size
1. M/s AJ Mirza Enclex 40 Form 5-A Legalized COPP M-260
Pharma (Pvt) (Enoxaparin Dy. No. 29 No. Registration
Ltd, Karachi sodium Injection R&I DRAP 831/MFG/WHO- Board
Cipla Ltd 289, IP 40mg/0.4ml dated 10-10- GMP/DFDA/201 deliberated that
Bellasis Road, Each prefilled 2014 2/1742 valid up WHO exempts
Mumbai syringe contains: Fee to 14-6-2014 Heparins and
Central, Enoxaparin deposited: from India Enoxaparin from
Mumbai 400 Sodium Rs. 100000/- Product License the condition of
008 India IP…….40mg. dated 10-10- No. 704 dated biosimilarity.
Equivalent to 4000 2014 08-4-2005 Keeping in view
IU anti-Xa Packs: 0.4ml DML No. this position, the
activity. PFS 831/MFG/CERT Board approved
Water for /DFDA/12/5863 the above
Injection dated 06-2-2012 products for
Ip…….q.s. registration as
per Import Policy
for Finished
Drugs.
2. M/s AJ Mirza Enclex 60 Form 5-A Legalized COPP M-260
Pharma (Pvt) (Enoxaparin Dy. No. 28 No. Registration
Ltd, Karachi sodium Injection R&I DRAP 831/MFG/WHO Board
Cipla Ltd 289, IP 60mg/0.6ml dated 10-10- GMP/DFDA/201 deliberated that
Bellasis Road, Each prefilled 2014 2/1734 valid up WHO exempts
Mumbai syringe contains: Fee to 14-6-2014 Heparins and
Central, Enoxaparin deposited: from India Enoxaparin from
Mumbai 400 Sodium Rs. 100000/- Product License the condition of
008 India IP…….60mg. dated 10-10- No. 704 dated biosimilarity.
Equivalent to 6000 2014. 08-4-2005 Keeping in view
IU anti-Xa Packs: 0.6ml DML No. this position, the
activity. PFS 831/MFG/CERT Board approved
Water for /DFDA/12/5863 the above
Injection Ip….q.s. dated 06-2-2012 products for
registration as
per Import Policy
for Finished
Drugs.
3. M/s Allmed ENOXA 2000 IU Dy No. 1140 Market M-260
Laboratories, anti Xa 20mg R&I dated authorization no. Registration
A-21/3 KDA Solution Injectable 23-5-2014 9233494 until Board
Scheme No. 1 2 Syringes / 0.2 ml valid 05-2017 deliberated that
Ext Karachi One prefilled 15000 dated Sole agency WHO exempts
Pakistan syringe of 0.2 ml 02-1-2012 agreement dated Heparins and
contains: 85000/- 23-11-2015 Enoxaparin from
Les Enoxaparin dated 11-10- the condition of
Laboratories Sodium 2012 Clexane prefilled biosimilarity.
Medis Route ……20mg syringes Keeping in view
De Nabeul Km As per PRC/ (MHRA) this position, the
78000 Pack of 2‘s Board approved
NabeulTunise syringes Clexane PFS of the above
Sanofi Karachi products for
registration as
per Import Policy
for Finished
Drugs.
4. M/s Allmed ENOXA 4000 IU Dy No. nil Market M-260
A-21/3 KDA Solution Injectable 26/5/2014 9233494 until Board
Ext Karachi 15000 dated Sole agency WHO exempts
Pakistan One prefilled 02-1-2012 agreement dated Heparins and
syringe of 0.4 ml 85000/- 23-11-2015 Enoxaparin from
Les contains: dated 11-10- Clexane prefilled the condition of
Laboratories Enoxaparin 2012 syringes biosimilarity.
Medis Route Sodium...…40mg (MHRA) Keeping in view
De Nabeul Km As per PRC/ Clexane PFS of this position, the
78000 Pack of 2‘s Sanofi Karachi Board approved
NabeulTunise syringes the above
products for
registration as
per Import Policy
for Finished
Drugs.
syringe of 0.6 ml 85000/- 23-11-2015 Enoxaparin from
Les contains: dated 11-10- Clexane prefilled the condition of
Laboratories Enoxaparin 2012 syringes biosimilarity.
Medis Route Sodium...…60mg (MHRA) Keeping in view
De Nabeul Km As per PRC/ Clexane PFS of this position, the
78000 Pack of 2‘s Sanofi Karachi Board approved
NabeulTunise syringes the above
products for
registration as
per Import Policy
for Finished
Drugs.
syringe of 0.8 ml 85000 dated 23-11-2015 Enoxaparin from
Les contains: 11-11-2011 Clexane prefilled the condition of
Laboratories Enoxaparin syringes biosimilarity.
Medis Route Sodium...…80mg As per PRC/ (MHRA) Keeping in view
De Nabeul Km Pack of 2‘s Clexane PFS of this position, the
78000 syringes Sanofi Karachi Board approved
NabeulTunise the above
products for
registration as
per Import Policy
for Finished
Drugs.
7. M/s Genome Enoxan 4000 Form 5-A,
Legalized CoPP M-274
Pharma, House Enoxaparin Dy. No. 2321
No.91932 issued Registration
No.593-B, Sodium- (R&I) Date:
on 24-08-2016, Board deferred
Street No.10, 100mg/ml. 0.4ml 11-05-2017
Legalized GMP the instant
Chaklala Parental Injection Rs. 100,000/-
No.92783issued application and
Scheme-III, (Prefilled syringe) Date: 10-05-
on 27-08-2016, advised DBER to
Rawalpindi 2017 Legalized place all cases of
Each Prefilled Market Enoxaparin in
Manufacturer syringe (0.4 ml) Pack of 2 Authorization next meeting for
: contains: PFS each of Letter valid up to revision of
M/s Enoxaparin 0.4ml January,2019. previous decision
AlborzDarou Sodium of Board.
Pharmaceutical (BP)…4000 IU
Company,
Hekmat 8thSt.,
AlborzInd.City
,Ghazvin-Iran.
The division has reviewed the pathways of below mentioned reference countries for submission of
data regarding LMWH which are detailed as under:
Health Canada EMA USFDA
Comparative Comparative USFDA has developed five criteria approaches:

quality, clinical quality, (1) the physical and chemical characteristics of enoxaparin,
and non-clinical clinical and
non-clinical (2) The nature of the heparin material and the chemical process
data. data. used to break up heparin chains into smaller pieces,
(3) The nature and arrangement of components that constitute

enoxaparin.
(4) certain laboratory measurements of the product‘s

anticoagulant activity, and
(5) Certain aspects of the drug‘s effect in humans.
FDA also evaluates impurities in the generic enoxaparin product,

particularly with respect to their effect on immunogenicity
WHO Technical Report Series No. 999, 2016

Review of products on the market
In 2009 one NRA clarified the ―appropriate regulatory pathway‖ for dealing with changes in the
regulatory oversight of low molecular weight heparins1 to reflect the fact that in future they
would be regulated in that country as biologicals and not as small-molecule pharmaceuticals (16)
In addition, it was announced that any biosimilar heparin submissions should follow the
regulatory framework for biosimilars and not the generic pathway. A transition period of 12
months was set to allow manufacturers to update their files to reflect the data required for
biologicals.
(16 Policy Statement: Clarifying the appropriate regulatory pathway for subsequent entry low
molecular weight heparins. Ottawa: Health Canada; Draft date 12 August 2013 (http://www.hc-sc.
gc.ca/dhp-mps/brgtherap/applic-demande/guides/lmwh-pol-hfmm-eng.php, accessed 18 June
2015)
M/s AJ Mirza Pharma (Pvt) Ltd, Karachi submitted a letter dated 29th March 2018 regarding
Enclex 40 and 60 (Enoxaparin Sodium Injection IP 40mg/0.4ml and 60mg/0.6ml) which is
manufactured at Cipla Ltd unit IX, which is belong to general category of injectable.
Decision: Registration Board deliberated the matter in detail and decided that for
registration of Enoxaparins the applicants shall provide the following
data/information with application:
i. The physical and chemical characteristics of enoxaparin.
ii. The nature of the heparin material and the chemical process used to
break up heparin chains into smaller pieces.
iii. The nature and arrangement of components that constitute
enoxaparin.
iv. Certain laboratory measurements of the product’s anticoagulant
activity
v. Certain aspects of the drug’s effect in humans.
Board further directed to obtain above data for cases cited above from Sr. # 1-
6 during inspection or before issuance of registration letter. Case at Sr. # 7,
shall be considered by Board after submission of above required
data/information.
f. Amendment in registration letter of Verorab (Reg. No. 009519) applied by M/s

Sanofi-aventis Pakistan Limited.
M/s Sanofi-Aventis Pakistan Limited had requested for amendment in the registration
letter of Verorab vaccine as per following details:
Registration. Name of Drug Pack Size as per Pack size as per firm
No. initial Reg. letter import.
009519 Verorab Single Dose 1 vial of powder + 1 PFS
Inactivated Rabies Syringe of diluent
vaccine
After the initial registration dated 25th March 1987 following post registration variations were
approved for Verorab vaccine:
S.No. Date Post Registration Variation
1. 20 Dec 2000 Change in Brand Name from Imovax Rabies Vero to Verorab
2. 10 Feb 2001 Change of Name of Manufacturer from M/s Pasteur Merieux Connaught
Lyon France to M/s Aventis Pasteur, Lyon France
3. 03 May 2006 Change of Name of Manufacturer from M/s Aventis Pasteur S.A France
to M/s Sanofi Pasteur S.A France
4. 31 Jan 2007 Price Re-fixation
5. 04 Mar 2008 Transfer of Registration from M/s Sind Medical Stores Karachi to
Sanofi – Aventis Pakistan Limited
Firm requested for amendment in pack size of already registered rabies vaccine. The firm
has not submitted any fee for this amendment.
Decision: Registration Board directed M/s Sanofi-aventis Pakistan Limited, Karachi for
personal hearing before Registration Board to clarify the import status
whether the above product is imported in vial or PFS from initial registration
till date.
g. Relocation of Sanofi Pasteur Headquarter France.
M/s Sanofi-Aventis Pakistan Limited informed that from October 2nd, 2017 M/s Sanofi
Pasteur Headquarters in France has been relocated at the following address:
Former headquarter New headquarters

Address Address
Sanofi Pasteur S.A Sanofi Pasteur

2 avenue Pont Pasteur 14 Espace Henry Vallee
69007 Lyon 69007 Lyon
France France
The name of the firm is also change from Sanofi Pasteur S.A to Sanofi Pasteur. The particular
―S.A‖ (―SocieteAnonyme‖, i.e. anonymous society in French) correspond to the legal form of the
company and stands for ―Ltd.‖ (Limited).
This change will be applicable on following products:
Product Name Reg. No.

Avaxim 160 028461
Avaxim 80U 047525
bOPV 072532
Imovax Polio 045700
Imovax Polio 10 vials 077526
Oral Polio Monovalent Type I 043066
Pentaxim 045699
Stamaril 025264
TrimovaxMerieux 009164
Typhim 014610
Vaxigrip 025266
Verorab 009519
Hexaxim 079275
Following documents submitted by the firm:

a. Copy of former and new chamber of commerce certificates.
b. Current manufacturing authorization of Marcy I‘Etoile and Val de Reuil sites.
Decision: Registration Board did not accede to the request of the firm as the approval of
change of head quarter is not covered under the rules.
h. Exemption from labeling text on low volume oncology and specialty care products.
M/s Sanofi Aventis Pakistan Limited has submitted following application for exemption
from labeling text on low volume Oncology and specialty care products:
Registration No. Importer and Manufacturer Name Product Description
083176 M/s Sanofi-Aventis Pakistan Thymoglobuline (Powder for
Limited concentrate for solution for
Plot No.23, Sector, No22,Korangi infusion)
Industrial Area, Karachi Each vial contains:
Manufacturer: Rabbit anti-human thymocyte
M/s Genzyme Polycolonals S.A.S, 23 immunoglobulin…… 25mg
boulevard Chambaud de la Bruyere, Packaging:Vial
69007 Lyon-France
The firm submitted the following documents:
1. Drug license by way of wholesale
2. List of Major Institutes purchasing Thymoglobuline and other Oncology Medicines.
3. Photocopy of SOP of Sanofi-Aventis Pakistan Limited.
4. Photocopy of Labeling Order Form.
5. Photocopy of Registration Letter having registration.
Thymoglobulin is a registered product of M/s Sanofi-Aventis and is being manufactured in

large volume at the source point from which supplies are made to various countries according to
their needs. In Pakistan it is not feasible to incorporate some of the requirement of labeling rules
at the source point.
The company has provided following detail pertaining to sales record of Thymoglobuline
for which the exemption is requested:
Sales Record:
Product Name No. of Units Import No. of Units Sold Sales Record (units) (IMS
Black Book)
Thymoglobulin 2015 2016 2017 2015 2016 2017 MAT MAT MAT
e 25mg/5mL Q32015 Q32016 Q32017
495 1,699 3,300 1,314 2,060 2,141 927 2,174 1,430
Thymoglobuline is a Lifesaving product and critically needed essential drugs for patients
in needs. The company is proposing for import of standard export packs of this medicine and
locally reprint registration number and MRP and the company already following the same
process for all Sanofi Vaccines.
In view of above the company is requesting for grant of permission to import
Thymoglobuline in Standard Export Packs in English Language with assurance that local re-
printing of MRP and registration number would be done prior to releasing the goods.
Decision: Registration Board acceded to the request of the firm for import of already
registered Thymoglobuline (Powder for concentrate for solution for infusion)
vide Reg. No. 083176 in Standard Export Packs. The Board advised the firm
to locally print MRP and Registration Number along with Urdu Text before
sale of drug at M/s Sanofi Aventis, Plot 23, sector 22, Korangi Industrial area,
Karachi to comply requirement as per Drugs (Labelling & Packing) Rules,
1986.
i. Request for registration of Vaxigrip TetraTM, suspension for injection PFS
quadrivalent influenza vaccine (split virion, inactivated)- Box of 1 dose syringe for
tender purpose only (Hajj 2018)
M/s Sanofi Aventis Pakistan Limited has biological product VaxigripTetraTM approved in
267th meeting of Registration Board held on 20-21st February 2017 as per following detail:
Dy No & Date of Documents

Importer and
application Fee detail
Manufacturer Brand name and composition
submitted Pack size/
Name
Demanded Price
M/s Sanofi- VaxigripTetraTM Form-5A Dy. No. Legalized

Aventis Pakistan (Suspension for injection prefilled 1061 dated 13-02-17 CoPP No.
Limited syringe, quadrivalent influenza 100000 dated 1002- 007742 dated
Plot No.23, Sector, vaccine (split virion, inactivated) 17 1200/- pack of 1‘s 13-10-2016
No22,Korangi
Industrial Area,
Karachi Each 0.5ml contains:
A/California/7/2009(H1n1) pdmm09-
like strain
Manufacturer:
(A/California/7/2009, NYMC X-
M/s Sanofi 179A):15mcg
Pasteur SA, 2 HAA/Texas/50/20152(H3n2) – like
Avenue du Pont strain A/Texas/15/2012/NYMC x -
Pasteur 69007 0223A: 15mcg
Lyon France HAB/Massachusetts/2/2012(Yamagat
a lineage) : 15mcg
HAB/Brisbane/60/2008(Victoria
lineage) : 15mcg HA
This product VaxigripTetraTM was recommended for registration in DRB 267th meeting
and is currently awaiting pricing approval. Annual influenza vaccination is considered to date as
the most effective method for preventing seasonal flue and its complications. Vaccination is
especially important for people at higher risk of serious influenza complication and for people
who live with or care for high risk individuals.
Currently licensed trivalent seasonal influenza vaccines of M/s Sanofi-Aventis namely
Vaxigrip having Registration No.025266 confer protection against three different influenza A
virus subtypes (H3N2 and H1N1) and one influenza B virus, while Sanofi Pasteur‘s new
quadrivalent influenza vaccine VaxigripTetraTM includes two A strains and B strains
corresponding to both of the B lineages.
Influenza B represents nearly one-quarter of circulating influenza viruses and results in
illness indistinguishable from that caused by influenza A. Co-circulation of two B-strain lineages,
which began two decades ago, has resulted in frequent differences between the B strain in
trivalent vaccine and the predominant circulating B strain, leading to suboptimal protection.
Quadrivalent influenza vaccines with both B strain lineages have developed to address this issue.
The Ministry of Health of Saudi Arabia recommends that international pilgrims be
vaccinated against seasonal influenza with most recently available vaccine prior to arrival,
particularly those at increased risk of severe influenza disease including pregnant women,
children aged over 5 years, the elderly and individual with pre-existing health conditions such as
asthma, chronic heart or lung diseases and HIV/AIDS infection.
The Ministry of Religious Affairs Pakistan is expected to announce tender for Hajj
vaccination in early April 2018. Therefore, the company is requesting for grant of registration of
Vaxigrip TetraTMfor tender purpose to make Flu vaccine available for the Pakistan pilgrims going
for Hajj this year.
Decision: Registration Board directed the concerned division to process as per practice
already in vogue.
j. Application for change of address of M/s Forward Solutions.
M/s Forward Solutions, animal health company has informed that they had changed their
office address:
Former Addressed New Address as per DSL
Plot No.66-West Wood Colony Plot No.19/B off AdbulSattarEidhi Road

ThokarNiazBaid, Lahore Near QazalbashChowk, Lahore
Firm requested to inspect their new premises and change the address on registration letter
of following products:
Product Name Reg. No. Documents submitted by the firm
OLVAC ONE DAY 028461 a. Fee deposit slip Rs. 5000/-

b. Copy of DSL.
EDS OLVAC 047525 c. Copies of Reg. letters.
BIO-VAC LS H120 072532
AI-OLVAC H9 045700
BIO-VAC ND IB 077526
BIO-VAC SGP 695 043066
IBA VAC 045699
BIO-VAC LASOTA 025264
Decision: Registration Board deferred the case for opinion of Legal Affairs Division
regarding following matter:
i. Either fee of Rs. 5000/- is required for the change in address of storage
facility for already registered multiple products or separate fee for
each product is required.
ii. Clarification regarding proprietor-ship of the firm of both DSLs.
k. One-time permission of MENCEVAXTM to be imported in GSK packaging during

transition phase (recent transfer to Pfizer Pakistan) to supply for MORA (Ministry
of religious affair) Hajj tender 2018.
M/s Pfizer Pakistan Limited has submitted following application regarding one-time
permission of its registered product MENCEVAXTMapproved in 273rdmeeting of Registration
Board. The product shall be imported in GSK Packaging during transition phase (recent transfer
to Pfizer Pakistan) to Supply for Mora Hajj Tender 2018.
Registratio Name of importer and

Product Description
n No. Manufacturer
085889 M/s Pfizer Pakistan Mencevax(Powder and Solvent for solution for
Limited injection)
Product license holder: Each dose contains:

M/s Pfizer S.A., Meningococcal polysaccharides, purified, Lyophilized
Boulevard de la Plaine serogroups A ……. 50 µg
17, 1050 Brussels, serogroups C ……………50 µg
Belgium. serogroups Y ………….. 50 µg
Manufacturer:
M/s GlaxoSmithKline Sterile Solvent:
Biologicals SA, 89, rue Each 0.5ml contains:
de I‘Institut, 1330 Sodium Chloride ……… 4.5mg
Rixensart, Belgium Phenol ………………… 1.25mg
Water for injection q.s pro … 0.5ml
Packaging:
10 dose (5ml) vial
The product was initially owned by M/s GSK till end December 2017, and M/s Pfizer is
still undergoing transition phase. Therefore, considering the limited time remaining for the roll out
of the Hajj 2018 tender and supplies by May 2018, M/s Pfizer Pakistan would only be able to
supply the vaccine in its old/unchanged packaging bearing logo of former MA holder M/s
GlaxoSmithKline‘s. As the revision of artwork usually takes around 06 to 09 months due to the
complexities involved in the process for imported products.
Moreover, Meningococcal Polysaccharide Vaccine is one of the mandatory vaccination
required for Hajj pilgrim before embarking for Hajj. Therefore, high level of inventory has been
maintained keeping in view every year MENCEVAXTM successful qualification for MORA
tender based on high quality & efficacy profile. In addition, as per tender supply readiness plans,
early production is required in order to meet timely supplies of huge quantities.
The same information has already been communicated to MORA by M/s Pfizer Pakistan
for their awareness. In light of the above, the company is requesting for to import of
MENCEVAXTM in GSK (previous MA holder) packaging for MORA Hajj 2018 tender supplies.
Decision: Registration Board advised to refer the case Legal Affairs division with
complete details for their comments.
AD-I
Case No. 5 Documents and fee required for change in manufacturing site after approval
and before issuance of Registration letter.
The division of Biological division comes across applications which apply for change in
manufacturing site after approval and before issuance of registration letter. In this regard
i. M/s Shamco Traders Pvt Ltd Lahore has submitted fee of Rs. 100,000/- and CoPP for
new site.
ii. M/s Excel Health Care Laboratories (Pvt) Ltd has just submitted CoPP for new site.
iii. M/s Sci-life Pharma (Pvt) Ltd., Karachi has submittedjustGMP for new site.
Biological division seeks guidance for provision of fee and set of other documents
required from the firm in this case.
Decision: Registration Board deferred the case for the comments of Legal Affairs
Division regarding requirement of Fee and documents for change in
manufacturing site of already approved products for which registration
letters have not been issued.
Case No. 6 Import of Veterinary Biological drug of M/s Saadat International Lahore with
different brand name but same registration number.
Firm requested to issue a clarification letter so that record could be updated accordingly.
As per our record we never imported the strain/pack H-52 as the product transfer to us was the
strain/pack H120 only, so we have been importing Bioral H-120 registration no 006859 and
renewed as such till now. So registration no 006859 is related to only Bioral H-120 instead of
Bioral H52 and H-120.
Biological division has received letter from Assistant Director (I&E) where they have
requested for clarity of the ambiguity of two products given a single registration number. Details
of the product areas under:
S. No. Name of Product Strength Reg. No.
1. Bioral H120 Injection 5000 doses 006859
Furthermore, it is stated in the letter that as per copy of initial registration letter submitted by the
firm, two different products Bioral H-52 and Bioral H-120 have been registered against same
registration number i.e. 006859. The firm has now applied for clearance certificate for import of
Bioral H-120.
Documents attached with the letter are with the following details;
 Initial registration was issued on 26thMarch, 1983 in the name of M/s May & Baker,
Wah Cantt. with the name Bioral H-52.
 On 27th April 1983 Ministry of Health, Special Education & Social Welfare (Health
Division), issued a letter in the name of said firm for the change in the name from
Bioral H-52 toBioral H-52 and 120.
 On 2ndNovember, 1993 grant of additional packs (10 x 1000 doses) were issued in the
name of M/s Rhone Poulence Pvt. Ltd., Lahore.
 Letter for change of name of manufacturer of registered drug under the drugs act, 1976
from rhonemerieux to Merial, France dated 16th September, 1999.( for Bioral H-120)
 Letter for change of name of local agent form Rhone-Poulence(Poulence(Pvt) Ltd to
Aventis Cropscieces Pakistan (Pvt) Ltd dated 6th June 2000 (forBioral H-120)
 On 5thJanuary, 2002 grant of additional packs (10 x 5000 doses box) were issued in the
name of M/s Aventis CropScience Pakistan (Pvt) Ltd., Lahore. (for Bioral H-52 and
120)
 Transfer letter from M/s Aventis CropScinence Pakistan (Pvt) Ltd to M/s Marush
(Pvt) Ltd dated 6th January 2003(Bioral H-120).
 Renewal of Registration(Bioral H-120) applied by M/s Marush Pvt Ltd dated 21st
July, 2007.
 Transfer letter from M/s Marush Pvt Ltd to M/s Saadat International Lahore dated
27thMarch 2010 (Bioral H-120)
 Renewal of Registration (Bioral H-120) applied by M/s Saadat International Lahore
dated 25th March, 2015.
Decision: Registration Board deferred the case and advised DBER to take import status of
5 years for Bioral H120 and Bioral H-52 Injection from DRAP, Lahore.
Case No. 7 Non-availability of Veterinary Biological drugs in country of origin applied by

M/s Saadat International.
Following products of M/s Saadat International, Lahore were approved in 258th meeting of
Registration Road. The details are as follows:
Sr. Name of Brand Name & Composition Type of Documents Decision
No. Importer & Form Details of RB
Manufacturer Dy. No.
Date of
Application
Fee Status
1. M/s Saadat GALLIMUNE MG Form-5A Legalized Approved
International (inactivated vaccine in oil adjuvant Dy. No 962 CoPP No as per
Lahore. against dated 01-10- 27/2015/NC import
Mycoplasma gallisepticum infections of 15 dated policy
Merial Italia poultry) 100000/- 18-03-2015 and as
S.p.A Via Each dose of 0.3 ml contains: dated Legalized per valid
Baviera 9 Mycoplasma gallisepticum, strain S6 01-10-2015 GMP NBF/ legalized
35027 inactivated minimum titre before Decontrolled 17/2014/V CoPP.
NoventaPadova inactivation 109 CFU. / dated
na (PD) Italy Active Immunization of healthy 300 ml vial 19-03-2014
breeding and laying stock against (1000 doses)
mycoplasma.
Route of adm: SC/IM
Shelf life: 24 months

2. M/s Saadat GALLIMUNE 403 Form-5A Legalized Approved
International ND+IB+IBD+REO Dy. No 961 CoPP No as per
Lahore. (Inactivated vaccine in oil adjuvant dated 01-10- 28/2015/NC import
Merial Italia against New castle disease , 15 dated policy
S.p.A Via Infectious bronchitis, Infectious bursal 100000/- 18-03-2015 and as
Baviera 9 disease and Avian viralArthritis). dated Legalized per valid
35027 Each dose of 0.3 ml contains:- 01-10-2015 GMP NBF/ legalized
NoventaPadova Newcastle disease virus Decontrolled 17/2014/V CoPP.
na (PD) Italy (Ulster 2C strain), / dated
inactivated, minimum titre before 300 ml vial 19-03-2014
inactivation 108 EID50 (1000 doses)
Infectious bronchitis virus (Mass
41strain),
inactivated, minimum titre before
inactivation 106.7 EID50
Infectious bursal virus
(VNJO strain), inactivated, minimum
titre before inactivation 105.7CCID50
Avian viral arthritis
reovirus (S1133 strain),
inactivated, minimum titre before
inactivation 107 CCID50
Avian viral Arthritis
Shelf life: 21 months
Route of Adm: SC/ IM
Before the issuance of registration letter, it was found that the products are not available in the
market in country of origin. A letter vide F. No. 3-95/2015-DDC(BD)(Vol.I)(M-258) dated 19-
12-2016 was issued to the firm for clarification regarding above matter.The firm submitted the
following reply from their principal manufacturer:
Gallimune MG:
Product is not registered locally (Italy) as the disease against which it is indicated
is not prevalent or it is not the part of vaccination programs. But it is registered in various
countries as per their local demand/ disease prevalence.
Gallimune 403 ND+IB+IBD+REO:
Product is not registered locally (Italy) as the said combination of vaccines is not
the part of vaccination programs. But it is registered in various countries as per their local
demand/ disease prevalence.The reply of the firm was taken in 267th meeting of the Registration
Board wherein the board decided as under;
"Registration Board advised the firm to provide the approval status of evidence of
registration of above product manufactured in the applied facility is approved by
any of the regulatory authorities from USFDA, EMA, PMDA Japan, Australia
TGA, Health Canada, Switzerland or any of regulatory authority of former
erstwhile Westren Europe (United Kingdom, Germany, France, Switzerland,
Netherlands, Austria, Belgium, Denmark, Finland, Sweden, Italy, Ireland,
Luxemburg, Norway, Scotland and Spain) or three stringent regulatory bodies of
former erstwhile Eastren Europe."
Moreover, following products of M/s Saadat International, Lahore were deferred in 258th meeting
of Registration Board. The details are as follows:
Sr. Name of Importer & Brand Name & Type of Documents Decision of RB
No. Manufacturer Composition Form Details
Dy. No.
Date of
Application
Fee Status
3. M/s Saadat GALLIMUNE Form-5A Legalized Deferred
International ART Dy. No 2400 CoPP 123/ forclarification by the
Lahore. (Inactivated dated 02-12- 2015/ NC firm for non-
vaccine in oil 15 Dated availability of
Merial Italia adjuvant against 100000/- 07-08-2015 formulation by
S.p.A Via Infectious Avian dated Legalized thecompetentregulatory
Baviera 9 Rhinotracheitis 01-12-2015 GMP NBF/ body ofcountry of
35027 Decontrolled 17/2014/V origin.
NoventaPadovana(PD) Each dose of 0.3ml / dated
Italy contains: 300 ml vial 19-03-2014
Avian (1000 doses)
Rhinotracheitis
virus, VCO3 strain,
inactivated, at least
60IPU
Active
immunizationof
laying and breeding
stocks against
avian rhinotractitis.
Shelf life:
24months
Route of adm: SC/

IM
4 M/s Saadat GALLIVAC REO Form-5A Legalized Deferred for
International (Live freeze dried CoPP No clarification by the
Lahore. vaccine against Dy. No 963 29/2015/NC firm for non-
avian dated 01-10- dated availability of
License viral arthritis) 15 18-03-2015 formulation by the
holder: 100000/- Competent regulatory
Merial Italia Each dose of 0.2 dated body of
S.p.A Via VittorPisani ml contains: 01-10-2015 country of origin.
16 Avian arthritis Decontrolled
20124 Milano reovirus, S1133 /
strain, at least 1 vial x 1000
Manufacturer: 104TCID50 doses
IZO S.r.l. a 10 vial x
socio unico, Vaccination of 1000
StradaStatale breeding stock doses
234 Km 28200, against viral
27013 Chignolo arthritis
PO Italy Route of adm: SC
Shelf life 24
Months
The firm submitted the following reply from their principal manufacturer:
Gallimune ART:
Gallivac REO:
The reply of the firm was taken in 267th meeting of the Registration Board wherein the board
decided as under
"Registration Board advised the firm to provide the evidence of registration of above
formulation in regulatory authorities of USFDA, EMA, PMDA Japan, TGA Australia,
Health Canada, Switzerland or any of the regulatory authority of former erstwhile Western
Europe or minimum three stringent regulatory bodies of erstwhile Eastern Europe."
A letter vide F. No. 3-95/2015-DDC(BD)(Vol.I)(M-267) dated 11-04-2017 was issued to the firm
for provision of above documents. The firm has submitted Certificate of Pharmaceutical Product
for Products not Licensed to be placed on the market in Italy where it is mentioned that;
"Formulation/combination of the product is not required for the local market as it is
specially formulated to meet the importing country requirement"
Decision: Registration Board deferred the case and advised DBER to bring the
comparison in next Registration Board meeting with already approved such
cases.
Case No. 8 Change of name of product license holder by M/s Bayer Pakistan (Pvt.)
Limited, Karachi
M/s Bayer Pakistan (Pvt.) Limited, Karachi applied has applied for the change in product
license holder and in name of manufacturer of their already registered product as per following
details:
Reg. No.& Brand Name & Current Name of Proposed Name of
Date of Composition Manufacturer Manufacturer
registration
077550 Eylea Bulk Manufactured Bulk Manufactured by:
Solution for Injection by: -No Change-
06-04-2015 Aflibercept 40mg/ml Regeneron
Each vial contains: Pharmaceuticals, Inc 81
Aflibercept 40mg/ml Columbia Turnpika
(recombinant homodimeric Rensselaer, New York
glycoprotein, MW 115,000 D 12144, USA
approximately) Not mentioned in Primary Packaging:
registration letter Vetter Pharma - Fertigung
GmbH & Co KG,
Germany
Secondary Packaging, Secondary Packaging,
testing and release by: testing and release by:
M/s Bayer Pharma AG M/s Bayer AG
Mullerstraβe 178, Mullerstraβe 178, 13353,
13353, Berlin, Germany Berlin, Germany
Market Authorization Market Authorization

Holder: Holder:
Bayer Pharma AG, D- Bayer AG, 51368
133 Berlin Germany Leverkusen, Germany
Imported and Imported and Marketed
Marketed by: by:
Bayer Pakistan (Private) -No Change-
Limited C-21, S.I.T.E.,
Karachi, Pakistan
The firm has submitted following documents:

a. Application along with fee challan of Rs. 5000/-
b. Copy of Initial registration letter.
c. Valid legalized CoPP No. 11/17/111878 dated 18-08-2017 issued by EMA indicating
new name of manufacturer and new product license holder.
Registration Board in its 240th meeting formulated following SOPs for change in name of
manufacturer of imported drugs:
manufacturer‘s name OR Original and legalized GMP certificate of new manufacturing
sitewith free sale certificate from regulatory body of country of origin.
In this context, all the requisite documents for change in name of manufacturer are complete and
Registration Board in its 262nd meeting authorized its Chairman for the approval of change in
name of manufacturer of imported drugs. However, there are no SOPs for the change of product
license holder and it is evident from the submitted CoPP that not only the name of product license
holder is changed but the address of product license holder is also changed.
It is submitted that the case was forward to Chairman Registration Board and change in
Secondary Packaging, testing and release was approved and rest changes are placed for the
Registration Board's consideration please.
(Addresses information mentioned on CoPP)
1. Vetter Pharma - Fertigung GmbH & Co. KG, Eisenbahnstraβe 2-4, 88085 Langenargen,
Germany, (also responsible for quality control and primary packaging).
2. Regeneron Pharmaceuticals, Inc 81 Columbia Turnpika Rensselaer, New York 12144,
USA (site also responsible for quality control).
Sites responsible for quality for quality control:
3. Bayer AGMullerstraβe 178, 13353, Berlin, Germany (also batch release in the EU and
secondary pakaging).
4. Vetter Pharma - Fertigung GmbH & Co. KG, Schutzenstraβe 87, 99-101, 88212
Ravensburg, Germany.
5. Vetter Pharma - Fertigung GmbH & Co. KG Moowiesen 2, 88214 Ravensburg,
Germany
6. Bayer AG, Friedrich-Eber-Straβe 217-333, 42117 Wuppertal, Germany.
7. Bayer AG, Kaiser-Wilhelm-Allee, 51368, Leverkusen, Germany.
Decision: Keeping in view valid legalized CoPP and approval of EMA (Reference
Regulatory Authority/country); Registration Board approved the change in
market authorization holder from M/s Bayer Pharma AG, D-133 Berlin
Germany to M/s Bayer AG Mullerstraβe 178, 13353, Berlin, Germany and
M/s Vetter Pharma - Fertigung GmbH & Co KG, Germany as primary
packaging site for Eylea Solution for Injection (Reg. No. 077550).
Case No. 9 Exemption of Bar Code applied by M/s Bayer Pakistan Pvt Ltd
M/s Bayer Pakistan Pvt Ltd applied for Exemption of Barcode for Biological Product
Eylea Solution for injection” wherein the company quoted earlier letters vide No.BPH-DRAP-17-
159 dated 13-Nov-2017 & BPH-DRAP-17-174 dated 19-Dec-2017 on same the subject
mentioned above. The company has stated following;
"Eylea is imported as finished product from Germany. We have requested for exemption
due to the technical reasons and hereby apply for exemption of barcode on imported registered
Biological product Eylea Solution for Injectionin reference to sub-rule 12 of rule 3A of SRIO
47(I)/2017 dated 14th June 2017.
"Registration Board for the purpose of giving effect to this rule may allow relaxation of any of the
condition in rule 3 or in this rule to resolve any practical difficulty for a particular product or
class of products provided that safe administration of drug is not compromised."
Although Eylea can withstand exposures to room temperature (250C) such as those that
may occur during shipping and handling without compromising either the physical or chemical
stability of the product. As per stability, Eylea should be stored at 2-80C and temperature
excursions should be avoided but printing of barcode generates some heat which may alter the
storage requirement for Eylea.
In order to print barcode, 1st we have to take out product from mentioned stored condition
means storage condition will not remain 2-8°C. Then as the product comes in seal pack so we
cannot open the pack and take out vial from inside therefore printing barcode with biological
product inside will generate heat which will further change the storage condition.
Therefore, it is not recommended to take out product from this storage condition which
can cause temperature excursion and quality of product can be compromised. Therefore, with this
practical technical difficulty, therefore, we request you to kindly grant us exemption for printing
of barcode on Eylea."
Decision:
Registration Board deferred the application for further deliberation.
Case No. 10 Suspension of registration of Biological drug containing Daclizumab-

Zynbryta (Reg. No. 031305)
Information has been received from Pharmacy Services division DRAP through letter no.
F. No. 9-7/2017-DD(PS), that European Medicines Agency (EMA) on 7th March, 2018 has
recommended the immediate suspension and recall of Multiple Sclerosis Medicines Zinbryta
(Daclizumab). The details on EMA website are as under;
"EMA recommends immediate suspension and recall of multiple sclerosis medicine Zinbryta
Evidence indicates risk of serious inflammatory brain disorders
The European Medicines Agency (EMA) has recommended the immediate suspension and recall
of the multiple sclerosis medicine Zinbryta (daclizumab beta) following 12 reports of serious
inflammatory brain disorders worldwide, including encephalitis and meningoencephalitis. Three
of the cases were fatal.
A preliminary review of the available evidence indicates that immune reactions observed in the
reported cases may be linked to the use of Zinbryta. Zinbryta may also be linked to severe immune
reactions affecting several other organs.
To protect patients‟ health, EMA is recommending the immediate suspension of the
medicine„s marketing authorisation in the EU and a recall of batches from pharmacies and
hospitals.
No new patients should start treatment with Zinbryta. Healthcare professionals should
immediately contact patients currently being treated with Zinbryta and should stop their
treatment and consider alternatives. Patients stopping treatment must be followed up for at least 6
months (see more details below).
EMA‟s recommendation to suspend Zinbryta and recall the product is being sent to the European
Commission for a legally binding decision.
The company that markets Zinbryta (Biogen Idec Ltd) has already voluntarily requested a
withdrawal of the medicine‟s marketing authorisation and informed EMA of its intention to stop
clinical studies.
Information for patients
 If you are being treated with Zinbryta, contact your doctor to discuss your treatment.
 Do not take another injection of Zinbryta.
 Tell your doctor immediately if you have or experience symptoms such as persistent high
temperature, severe headache, nausea (feeling sick), tiredness, yellowing of the skin or
eyes and vomiting. These could be signs of a reaction to Zinbryta.
 Your doctor will carry out regular blood tests for up to 6 months after stopping treatment
to check for side effects.
 If you are in a clinical study with Zinbryta, contact the doctor treating you in the study.
Information for healthcare professionals

 Do not start any new patients on Zinbryta.
 Contact your patients currently being treated with Zinbryta as soon as possible and stop
their treatment. Consider alternative treatments as appropriate.
 Patients stopping treatment should be monitored at least monthly and more frequently as
clinically indicated for up to 6 months after the last dose of Zinbryta.
 Advise patients to immediately report symptoms of liver injury such as prolonged fever,
severe headache, tiredness, jaundice, nausea or vomiting. These reactions can occur for 6
months after treatment has been stopped.
 A recall of Zinbryta will take place from pharmacies and hospitals across the EU.
To date EMA‟s Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed 12 cases of
immune-mediated inflammatory disorders, including encephalitis. Most cases occurred within 8
months of starting treatment.
A previous PRAC review in 2017 found that unpredictable and potentially fatal immune-mediated
liver injury can occur with Zinbryta for up to 6 months after stopping treatment and concluded
that patients stopping treatment should be followed up.
It is submitted that as per record available with Biological Division, following product of M/s
Roche is registered with details as under;
Reg. No Drug Name Composition Manufacturer Country Importer Dosage Pricing
031305 ZENAPAX EACH 5ML F.HOFFMAN LA- SWITZERLA ROCHE PER Rs.23000
25MG/5ML VIAL ROCHE ND PAKIST VIAL
VIAL CONTAINS:- SWITZERLAND AN
DACLIZUMAB KARAC
25MG HI
It is submitted that Registration Board in its 262nd meeting delegated certain powers to its
Chairman which also include "Action initiated on safety of drugs". Therefore the case was
forwarded to Chairman Registration Board with the proposal of issuance of show cause notice and
he has agreed along with personal hearing of the case.
Decision: Mr. Abdus Samad, Head of Regulatory Affairs & quality Assurance of
M/s Roche Pakistan Limited, Karachi appeared before the Board and
informed that M/s F. Hoffman- La roche Ltd., Basel Switzerland had
voluntarily withdrawn marketing authorization of Zenapax (daclizumab)
globally in January 2009 due to commercial reasons. He further informed that
in Pakistan the product was imported till 2008 and the last import was in
August 2008. Furthermore, they did not renew the product since 2008 as they
want to withdraw the registration of Zenapax 25mg/5ml vial. Thus
Registration Board advised M/s Roche Pakistan Limited, Karachi to submit
last import status of Zenapax 25mg/5ml vial along with reason of not
submitting renewal application.
Registration Board further advised DBER to come up with a proposal
in forth coming meeting regarding the cases where the firms do not submit
renewal application in order to withdraw their registration without informing
DRAP.
AD-II
Case No. 11 Registration of veterinary vaccine applied by M/s Ghazi Brothers, Karachi.
The following veterinary vaccine of M/s Ghazi Brothers was considered in 273st meeting
of Registration Board and the Board decided as follows:
Name of Brand Name & Composition Committee Decision of

Importer & Recommendation RB
Manufacturer
M/s. Ghazi IzovacAviflu 9 Multidose Freeze-Dried Approved Approved
Brothers, Bottle
Karachi. Each dose of 0.5ml of vaccine
contains:-
M/s. IZOS.p.A., Inactivated Avian Influenza A, strain
Via A. Bianchi H9N2…………..320 H.A.U.
9, Brescia, Italy. (Immunological)
(For Veterinary Use).
Case History:
M/s Ghazi Brothers, Karachi has applied for the registration of following veterinary
vaccine. The case was approved in 241st meeting of Registration Board. Before issuance of
registration letter it was found that the above product is not licensed for sale in the country of
origin and the reason which is clearly mentioned on CoPP (No.50/2017/NC dated 24.04.2017) is
that the product has been developed exclusively for the treatment of conditions not endemic in the
country of export.
The case was taken up in 269th meeting of RB and the board decided as under;
“Registration Board advised the firm to provide the evidence of registration, if above
product manufactured in the applied facility is approved by any of the regulatory
authorities from USFDA, EMA, PMDA Japan, Australia TGA, Health Canada,
Switzerland or any of regulatory authority of former erstwhile Western Europe (United
Kingdom, Germany, France, Switzerland, Netherlands, Austria, Belgium, Denmark,
Finland, Sweden, Italy, Ireland, Luxemburg, Norway, Scotland and Spain) or three
stringent regulatory bodies of former erstwhile Eastern Europe”.
Now, the firm submitted new legalized CoPP and the following response;
I. IzovacAviflu 9 is not being marketed in said reference countries since the disease Avian
Influenza(AI) is not prevalent in these countries and in country of origin i.e. Italy, as on
the CoPP of IzovacAviflu 9, it has been clearly mentioned that; “The product has been
developed exclusively for the treatment of the conditions particularly tropical
diseases, not endemic in the country of export”.
II. There are many brands of Avian Influenza(AI) vaccines, manufactured in the reference
countries for export, being registered and marked in Pakistan e.g.
a. Nobilis Influenza H9N2 Vaccine manufactured by IntervetInternation B.V,
Holland.
b. Gallimune Flu H9 Injectable by Merial Italia S.p.A, Italy
c. Al-Olvac H9 by Fatro S.p.A, Italy.
d. Cevac New Flu H9K by Veva, Hungary.
Decision of 273rd meeting of RB:

Keeping in view the facts recorded above and GMP confirmation by Italian regulatory
authority, Registration Board approved the product as per valid legalized CoPP and
subject to compliance of Import policy for Finished Drugs.
During processing the case following differences have been noted.
i. Name of manufacturer/license holder as per old CoPP /as reflected in minutes of meeting
and other original documents including new CoPP submitted by the firm.
ii. Address of manufacturing site as per old CoPP /as reflected in minutes of meeting and other
original documents including new CoPP submitted by the firm.
The differences are tabulated as under;
Name & Name & Address Name & Brand Name & Decision of 273rd
Address of of Address of Composition meeting of RB
Manufacturer Manufacturer (As Manufacturer
(As per per New CoPP) (As per GMP
Minutes of & Power of
meeting & Old Attorney)
CoPP)
License Holder License Holder: M/s. IZO IzovacAviflu 9 Keeping in view
& StradaStatale Emulsified the facts recorded
Manufacturer M/s. IZO S.r.l a 234, Km inactivated vaccine above and GMP
M/s. IZO socio unico,Via 28,200-27013 Multi-dose Freeze- confirmation by
S.p.A., Via A. San Zeno 99/A- Chignolo Po Dried Bottle Italian regulatory
Bianchi 9- 25124, Brescia, (PV), Italy. Each dose of 0.5ml authority,
25124, Brescia, Italy. (As per GMP) of vaccine contains: Registration
Italy. - Board approved
Manufacturer: M/s. IZO S.r.l a Inactivated Avian the product as per
socio unico,Via Influenza A, strain valid legalized
M/s. IZO S.r.l a San Zeno 99/A, H9N2……. CoPP and subject
socio unico,Via Brescia, Italy. …320 U.HA to compliance of
S.S.234 Km 28,2- (As per Power (Immunological) Import policy for
27013 Chignolo Po of Attorney) (For Veterinary Finished Drugs.
(PV), Italy. Use).
In response to above the firm has submitted legalized letter from his principal I.Z.O S.r.l Italy
wherein it is stated that
“On 6-11-2012 the legal status and business name of I.Z,O S.p.A was changes to I.Z.O s.r.l a
socio unico. The reason of this change was the aim of simplifying the burocratic activities
related to legal status as required by national rule; And on 01-04-2013 the address of
headquarter was changed from Via Antonio Bianchi ,9 25124 Brescia to Via San Zeno,99/A
25124 Brescia Italy.”
Furthermore, the firm has explained that:
“the site of manufacturer remains same i.e. StradaStatale 234, Km 28, 200-27013 Chignolo Po
(PV) Italy as applied and mentioned in the GMP Certificate (copy enclosed herewith), submitted
in the initial application dated 03 July 2012, while the manufacturing site address is not
mentioned in the CoPP as submitted in initial application, the clause No.7 of site address is not
mentioned in the CoPP as submitted in initial application, only the address of office (i.e IZO
S.r.l) remains same as mentioned in the initial application, only the address of office of applicant
has been changed from “Via Antonio Bianchi, 9 25124 Brescia to Via San Zeno 99/ A 25124
Brescia Italy”. Therefore, the firm / company submitted the declaration by their principal IZO
S.r.l, duly legalized by Pakistan embassy in Italy.”
Remarks of evaluator:
From above explanation it is indicated that the Name & address of the Product license
holder/Head office has changed fromM/s. IZO S.p.A., Via A. Bianchi 9-25124, Brescia, Italy
to M/s. IZO S.r.l a socio unico, Via San Zeno 99/A-25124, Brescia, Italyduring the process of
registration while the name & address of the manufacturer remains the same. It may be noted that
the address of manufacturer mentioned on GPM certificate submitted along with the initial
dossier is the same as indicated in the recent CoPP.
Decision:
Registration Board acknowledged the above information.
Case No. 12 Imported veterinary Biologicals applied by M/s Bromed Animal Health
Lahore approved in 260thmeeting of Registration Board.
Following products of M/s Bromed Animal Health Lahore were approved in 260thmeeting
of Registration Board as per following details:
Name of Brand Name & Composition as per Brand Name & Composition as per
Manufacturer Form-5A/ Approved in minutes FSC
M/s Middle ME FLUVAC H9+ND 0.3% ME FLUVAC H9+ND 0.3%
East for Inactivated Bivalent Virus Vaccine Inactivated Bivalent Virus Vaccine of
Vaccines (ME against Avian influenza H9N2 and Avian influenza and Newcastle
VAC) Newcastle disease. disease,
Industrial area A/chicken/Egypt/114940V/NLQP/20
2 extention Composition: 11 (H9N2) and
part no. 22-24, Inactivated Avian Influenza A NDV/Chicken/Egypt/11478AF/2011
EL /Chicken /Egypt/114940v/NLQP (ND)
SalhyaGdeda, /2011 (H9N2)……≥10s8EID50/dose
Elsharkya before inactivation. Each dose before inactivation
Governorate contains:
Egypt Inactivated Newcastle Disease Inactivated Avian Influenza A
NDV/Chicken/Egypt/11478AF/2011 /Chicken /Egypt/114940v/NLQP
(ND)……≥108EID50/dose before /2011 (H9N2)……≥108EID50
inactivation.
Inactivated Newcastle Disease
Mantonied Isa 71VG…021 ml NDV/Chicken/Egypt/11478AF/2011
BNE ……..0.0005 G (ND)……≥108EID50
Bulk saline …… Q.S.to 0.3ml
Total ….. 0.3ml
ME FLUVAC H9 0.3% ME FLUVAC H9 0.3%
(Inactivated virus Vaccine against (Inactivated Avian Influenza virus
Avian influenza H9N2) Vaccine,
A/chicken/Egypt/114940V/NLQP/20
Each (0.3ml) dose contains: 11(H9N2)
Inactivated Avian Influenza A Each dose before inactivation

/Chicken /Egypt/114940v/NLQP contains:
/2011(H9N2)……≥108EID50/dose Inactivated Avian Influenza virus, A
before inactivation. /Chicken
/Egypt/114940V/NLQP/2011(H9N2)
… …≥108EID50
In this context, it is submitted that the composition recorded in the minutes was as per Form-5A
which is almost the same as per FSC. However as per practice the registration letters are issued as
per composition mentioned in FSC.
Decision:
Case No. 13 Imported Human Biological applied by M/s OBS Pakistan (Pvt) Ltd., Karachi
approved in 256th meeting of Registration Board.
Following product of M/s OBS Pakistan (Pvt) Ltd., Karachi was approved in 256th
meeting of Registration Board as per following details:
Name of Brand Name & Composition as per Brand Name & Composition
Manufacturer CoPP as per minutes of RB
M/s Merck Sharp & Rota Teq® ROTATEQ
Dohme (Rotavirus Vaccine, Live, Oral, Oral Solution 2ml I
Corp, US. License # Pentavalent) Rotavirus Vaccine, Live,
0002 Oral Pentavalant
770 Sumney Each dose contains: 1 Single Dose Tube
town Pike, G1 Reassortant……. ….≥2.2x106IU/ dose
West Point, PA G2 Reassortant……. ….≥2.8x106IU/ dose
19486, USA. G3 Reassortant……. ….≥2.2x106IU/ dose
G4 Reassortant……. ….≥2.0x106IU/ dose
P1A[8] Reassortant.. ….≥2.3x106IU/ dose
In this context, it is submitted that while recording the minutes, the composition was
inadvertently missed. However, as per practice registration letters will be issued as per the
composition mentioned in CoPP.
Decision: Registration Board acknowledged the above information.
Case No. 14 Imported Human Biological applied by M/s Eli Lilly Pakistan (Private)
Limited, Karachi approved in 257th meeting of Registration Board.
Following product of M/s OBS Pakistan (Pvt) Ltd., Karachi was approved in 257th
Name of Brand Name & Composition as per CoPP Brand Name & Composition
Manufacturer as per minutes of RB
M/s Eli Lilly and Trulicity (dulaglutide) Injection Trulicity
Company,
Indianapolis IN Each Injection contains: Each Pen contains:-
46285, USA. Dulaglutide……..……0.75mg/0.5ml Dulaglutide……0.75mg/0.5ml
Trulicity (dulaglutide) Injection Trulicity
Each Injection contains: Each Pen contains:-
Dulaglutide………1.5mg/0.5ml Dulaglutide……..1.5mg/0.5ml
In this context, It is submitted that in the minutes of meeting word “Pen” was written
instead of “Injection” while the rest of the composition is same as mentioned in CoPP. However,
as per practice, registration letters will be issued as per composition of CoPP and registration.
Case No 15 Change of name of manufacturer applied by M/s Hospital Services & Sales,
Karachi for already registered product.
M/s Hospital Services & Sales, Karachi applied for the change in the name of their
principal company from M/s. ―Serum Institute of India Limited‖ to ―Serum Institute of India
Private Limited‖ for following registered diluent and this change is happened due to the
management decision of the principal company and there is no change in the directorship,
shareholding, management, control, constitution, ownership, address, etc. of the said principal
company. The details are as follows:
Reg. No. Product Name& Composition Pack Size Previous New Name of
Name of Manufacturer
Manufacturer
077518 Sodium Chloride Injection B.P one ml M/s Serum M/s Serum
ampoule Institute of Institute of
Each ml contains: India Limited, India Private
Sodium Chloride B.P… 0.9 % w/v India Limited, India
Water for injection B.P…. q.s.
(For Reconstitution of BCG
Vaccine Reg. No 053816)
The product BCG Vaccine B.P (Freeze Dried) for which the diluent is used for reconstitution
is WHO Prequalified and letter for change in name of manufacturer is already issued for the same.
The firm has submitted the following documents:
i. Product registration variation fee
ii. Legalized Principal Company‘s letter regarding change in the name of company name.
iii. Legalized Approval of the said change by Indian FDA – Pune, India
iv. Legalized CoPP with the new name of the manufacturer i.e. Serum Institute of India Pvt.
Ltd., India.
v. Legalized GMP Certificate with the new name of the company
vi. Legalized Certificate of Incorporation issued by the Registrar of companies, Ministry of
Corporate Affairs, Pune – INDIA
vii. Copy of product registration letter and last renewal status.
In this context, it is submitted that the approval of change of name of the firm by FDA India
and the submitted CoPP contains different address of Manufacturer/ License holder which is
reproduced as under:
Address of Manufacturer/License Holder as per Address of Manufacturer/License

CoPP Holder as per Approval letter by IFDA
M/s Serum Institute of India Pvt. Ltd., Room No.1, M/s Serum Institute of India Pvt. Ltd.,
First Floor, Survey No.46/1-4,Kadaiya Village, Nani 212/2, Hadapsar, Pune 411028
Daman-396210 (Maharashtra State), India.
C/o M/s Sovereign Pharma Pvt. Ltd., Survey No.46/1-

4, Kadaiya Village, Nani Daman-396210
The firm was asked to clarify the above matter and the firm submitted that the said diluent
has been manufactured by M/s Serum Institute of India Pvt. Ltd. (SIIPL) at Daman site
(Sovereign Pharma) and on License to manufacture for sale / distribution of Drugs submitted by
the firm it is clearly mentioned that ―M/s Serum Institute of India Pvt. Ltd., Room No.1, First
Floor, Survey No.46/1-4, Kadaiya Village, Nani Daman-396210 is hereby granted a loan license
to manufacture on the premises situated at Survey No.46/1-4, Kadaiya Village, Nani Daman-
396210 C/o M/s Sovereign Pharma Pvt limited‖.
It is further submitted that same type of clarification has already been presented and
accepted in 277th meeting of Registration Board regarding registration of sterile diluents of M/s
Sind Medical Stores, Karachi manufactured by the same manufacturer at the same site as
discussed in the instant case.
Registration Board in its 262nd meeting authorized its Chairman for the approval of change in
name of manufacturer of imported drugs. Therefore, the case was referred to Chairman
Registration Board and after the approval, the letter has been issued as per following details:
Reg. Brand Name & Pack Size Previous Name
New Approved Name of
No. Composition of Manufacturer
Manufacturer
077518 Sodium Chloride One ml M/s Serum
M/s Serum Institute of
Injection B.P. ampoule Institute of India
India Pvt. Ltd. on loan
Ltd., India
license basis by M/s
Each 1ml contains: Sovereign Pharma Pvt.
Sodium chloride B.P. : Ltd.
0.9% At: Survey No. 46/1-4,
Water for injection Kadaiya Village, Nani
B.P. : q.s. Daman-396210
AD-I
Case No. 16 Correction of manufacturing site address of M/s Mustafa Brothers
Following products of M/s Mustafa Brothers were approved in various meetings of

Registration Board. It is submitted that for all products mentioned below, address reflected in
approved minutes of RB and report of GMP inspection conducted by DRAP official is same while
it is different in GMP submitted by the firm. The details are as under;
Sr. Manufacturer Brand Name Address Address
No mentioned in mentioned in
minutes of RB GMP
meetings submitted by
the firm
1. M/s Federal Governmental ARRIAH Federal Federal

Budgetary Institution ―Federal GUMBORO VAC
Governmental Governmental
Centre for Animal Health‖ Budgetary Budgetary
(FGBI‖ARRIAH‖) Institution Institution
―Federal Centre ―Federal Centre
600901, Russia, Vladimir for Animal for Animal
region, Vladimir, Russia. Health‖ Health‖
2. M/s Federal Governmental ARRIAH IB H-120 (FGBI‖ARRIAH (FGBI‖ARRIA
Budgetary Institution ―Federal ‖) H‖)
Centre for Animal Health‖ 600901, Russia, 600901, Russia,
(FGBI‖ARRIAH‖) Vladimir region, Vladimir
600901, Russia, Vladimir Vladimir, region,
region, Vladimir, Russia. Russia. Vladimir,
3. M/s Federal Governmental ARRIAH microrayonYur‘
Budgetary Institution ―Federal GUMBORO evets Russia.
Centre for Animal Health‖ FORTE
(FGBI‖ARRIAH‖)
600901, Russia, Vladimir

region, Vladimir, Russia.
4. M/s Federal Governmental ARRIAH ND IB
Budgetary Institution ―Federal EDS 76
Centre for Animal Health‖
(FGBI‖ARRIAH‖)
600901, Russia, Vladimir

region, Vladimir, Russia.
5. M/s Federal Governmental ARRIAH ND LA-
Budgetary Institution ―Federal SOTA VAC
Centre for Animal Health‖
(FGBI‖ARRIAH‖)
600901, Russia, Vladimir region,

Vladimir, Russia.
6. Federal Governmental ARRIAH PPRV For Products

Budgetary Institution Federal mentioned at
Centre For Animal Health Sr. no. 6-7
(FGBI ARRIAH), 600901,
Vladimir, microrayon, Yurenets
Russia Federal
Governmental
7. Federal Governmental ARRIAH-VAC Budgetary
Budgetary Institution Federal Institution
Centre For Animal Health Federal Centre
(FGB) ARRIAH),600901, For Animal
Yurenets, Viadimir, Russia. Health (FGBI
ARRIAH),
600901,
Vladimir,
microrayon,
Yurenets Russia.
However, as per practice registration letters will be issued with address as per GMP certificate.
Decision:
Item No. V Quality Assurance & Lab. Testing DIVISION
QUALITY CONTROL CASES

Case No.1
a. The case of Substandard/Adulterated Injection Ofcil 100ml of M/s.
Mediceena, Lahore.
b. Sub-standard Almajax 250ml Suspension of M/s.Medisearch Pharma,
Lahore supplied to DHQ Hospital Hafizabad.
The Secretary Provincial Quality Control Board (PQCB) Punjab had forwarded the
recommendations of (PQCB) Punjab to DRAP on 22-11-2014 for taking action against the two
firms as per decision of PQCB Punjab in cases of supplying/ manufacturing of Sub-Standard drugs
of Ofcil 100 ml injection and Almajax 250 ml suspension by i.e, M/s. Mediceena Lahore and M/s.
Medisearch Lahore respectively.
The recommendations of PQCB forwarded to DRAP were two; one is to cancel the DML
of both firms and second was to cancel the registration of above two products. The matter was
discussed in 246th Meeting of Registration Board held on 11-12-2014 where the Registration
Board directed the DRAP, Lahore to submit the case background along with all relevant
reports and complete investigation taken from the Secretary PQCB, Punjab.
The case was again presented in the 250th Meeting of the Registration Board and decided
as under:-
“The Board has decided to send reminders to DDG (E&M) Lahore and FID Lahore for the
submission of report”.
In this regard DRAP, Lahore had forwarded two reports with their conclusions and along
with detailed documents from Secretary PQCB, Punjab for consideration of the Registration
Board. One report was related to Ofcil injection of M/s. Mediceena Pharma while other report was
related with Almajax Suspension of M/s. Medisearch Pharma.
A. The crux of the report of the firm M/s Mediceena Pharma is as under:-
Important points of the Inspection report conducted on 13-02-2015 of M/s Mediceena
Pharma Lahore are as under:-
i. Inj. Ofcil 200mg/100ml supplied to DHQ hospital Hafizabad was
manufactured in four batches.
ii. Documentation is satisfactory.
iii. BMR has been maintained for every batch of the drug.
iv. Necessary machinery is installed in the production section of respective
drugs. Production is under the supervision of qualified staff.
v. The firm has shown the record of internal and external calibration.
vi. SOPs are in place, HPLC UV spectrophotometer, rafractrometer, stability,
chamber, PH meter viscometer etc are available.
vii. FTIR is in the stage of installation.
viii. Working standards are available.
ix. Microbiology section is operational, colony counters in place, Two separate
sterilitytests for bacteria and fungi are being carried out.
x. The API used was imported and requisite NOC was taken.
xi. The stock might have been effected due to improper storage/ temperature.
xii. The case lying in PQCB, Punjab is subjuidice.
xiii. Firm has been de-sealed by the order of the court.
Conclusion of Inspection report by DRAP Lahore about M/st Mediceena is given as :-

“Firm has developed SOPs and systems to manufacture the drug under reference. Firm
has satisfactory compliance of GMP with reference to manufacturing section of drug
under reference. cGMP is continuous day to day process which require consistent efforts.
Storage conditions at hospital under reference may have also some impact on the product
under reference as stated by the firm Court observations are also enclosed”
B. The crux of the report of the firm M/s Medisearch Pharma is as under:-
Important points of the Inspection report of M/s Medisearch Pharma Lahore are given as
below:-
i. The Sub-Standard drug, Almajax Suspension, was supplied by M/s.
Pioneer Pharma.
ii. The cake with bad odour in suspension was observed after lapse of few
months of supply.
iii. The API was imported and requisite NOC was taken.
iv. The premises were neat and clean and provided with functional HVAC.
v. At the time of supply the drug Testing Laboratory declared the Sample as
of Standard Quality however, after 11 months hospital agitated complaint
for bad odour.
vi. The firm though having reservations on storage conditions of hospital was
ready to replace the stock.
vii. With reference to product specific comments, all proceedings of DTL
report, PQCB orders, sealing of premises, FIR and arrest had been done on
the same day i.e, 22-11-2014.
viii. The premises were de-sealed by the order of Lahore High Court and the
management got bail and the case is sub-juidice before the court.
Conclusion of Inspection report by DRAP Lahore about M/s Medisearch is as

under:-
“The firm was non operational at the time of inspection. After detail inspection of
the firm and evaluation of documents/data submitted by the firm there after
including BMRs, SOPs, Certificate of analysis etc has reveled certain gaps in the
Quality Assurance system. Firm made observation regarding storage condition at
hospital, DHQ, Hafizabad.”
1. Judgment made by court case of Medisearch:

Following observations were made by double bench on 23-12-2014 order sheet in the
mail application in case No. Crl.Misc.No.16828-B of 2014, Muhammad Unaiz Ali
verses the State etc.
“Records reflect that initially at the time of supply of the drugs in question, report
regarding the standardization of the same was positive, however, subsequently the
drugs were declared substandard. Learned Law Officer confirms that earlier
laboratory report regarding the standard of supplied drugs as positive, however,
contends that the concerned officials of the health department of that time involved in
purchase of substandard drugs have also been arrayed as accused in this case. It is the
case of the petitioner that disputed drugs have lost their efficacy only because of
keeping the same in the temperature above the one prescribed by the petitioners
company, however, the petitioners company has already shown its willingness to
replace the disputed drugs. In the given facts and circumstances of this case, we are of
the considered view that culpability of the petitioner in this case is a matter of further
inquiry as it is to be seen whether the drugs in question were substandard at the time of
their supply by the petitioners company or any change in the same has occurred
because of the high temperature in the relevant government stores. Offence against the
petitioner does not fall within the prohibitory clause of Section 497 Cr.P.C Therefore,
without further commenting upon the merits of the case, we allow this petition and
admit the petitioner to bail subject to this furnishing bail bonds in the sum of Rs.
100,000/- (Rupees one hundred thousand only) with two sureties each in the like
amount to the satisfaction of the learned Trial Court/Duty Judge.”
2. Judgment of the Lahore High Court, Lahore in court case of the Mediceena Pharma,
Lahore:-
(i) The samples were received by Drug Testing Laboratory on 18-11-2014.
(ii) The Drug Testing Laboratory through its report dated 22-11-2014 declared the
sample of infusion of Ofloxacin as ―Substandard‖ on the basis of ―Precipitated
particulate matter‖. Said report was dispatched on 22-11-2014 and was received by
the Drug Inspector on the same day. The main test of infusion ―sterility test‖ was
not performed by the Analyst.
(iii) On 23-11-2014 an FIR was lodged by the Drug Inspector against the petitioner and
its Chief Executive was arrested on 23-11-2014.
(iv) After going through the record, there is no doubt in the mind of this Court that the
petitioner was on purpose and by design victimized by the respondents. The
chronology of events shows that the respondents were bent on sealing the factory
premises/ manufacturing units of the petitioner and to destroy its business. The fact
that the Laboratory report was prepared on 22-11-2014 and was by the Drug
Inspector on the same day, when the meeting of the Provincial Quality Control
Board also took place which issued a show cause notice to the petitioner and also
passed the interim orders for sealing the factory premises of the petitioner is not
without coincidence and leads to the irresistible conclusion that the ultimate goal
of the respondents was to target and blacklist the petitioner.
(v) In the result, this petition is allowed, order dated 17-12-2014 passed by Secretary
Health is declared to be without lawful Authority and of no legal effect.
The matter is five years old and Honorable High Court has declared the actions of the
Secretary Health Punjab without lawful authority and of no legal effect and resultantly allowed
the petition 424/2015 filed by M/s Mediceena Pharmaceuticals Vs Govt of Punjab, wherein all
the merits of the case including test reports were discussed in detail
The firms have been called for personal hearing.
Proceedings:-
Mr. Uzair Nagra owner of M/s Mediserach lab Lahore appeared before the DRB and
explain his point of view that due process of law was satisfied by the PQCB and victimization was
prevailing as pointed out by the Honorable Court in their decision. He said that initially supplied
medicines samples were sent to DTL and the products were declared as standard quality. He also
pointed out that internal correspondence of the Hospital indicated high temperatures and lack of
proper storage facilities. Our company was sealed and owner was arrested and no opportunity was
given to explain our position. Same happened with mediceen Lab.
Decision: Registration Board after examination of Court orders, records, test analysis
reports and inspection report of DRAP Panels decided to resume the
production of the products in question of both firms subject to the following
conditions.
a. Both Companies should conduct evaluation of their products and prepare
themselves for product specific Inspection by the following panel:
 Additional Director Lahore.
 Area FID Lahore
 Area ADC Lahore
b. The panel will conduct PSI inspection of both the firm regarding their in
question products before 30th June, 2018.
c. The panel will be authorized to allow the production of the products in
question if satisfied with the facilities/product data available with the
firms.
d. The samples of the products shall taken for test analysis by the CDL
Case No.2 Manufacture & Sale of Sub-Standard Steimazol Lotion Batch No. GSTAC by
M/s Akhai Pharmaceuticals (Pvt) Ltd. Lasbela Balochistan.
The Sample of Steimazol Lotion Batch No. GSTAC Reg. No.024757, by M/S Akhai
Pharmaceuticals (Pvt) Ltd. Lasbela, Balochistan was taken by FID-(Q) at Karachi, on 25-01-2017
from manufacturer‘s premises for test/analysis and send to the CDL Karachi. However the sample
was declared substandard by Federal Government Analyst vide Test report No.KQ.57/2017, dated
17th February 2017.
The result of CDL on the basis of which sample under reference has been declared sub-
standard are reproduced as under:-
pH Determined: 9.96
Limits: 5.0 to 7.0
Result: Does not comply
Remarks: The sample is substandard quality under the Drug Act 1976.
On explanation letter issued by the FID dated 20-01-2017 to the firm. However,
in reply of the firm they claimed that their product compliance the manufacturer specifications
they have to keep the PH 7-10
Recommendation of the FID
The FID (Q) on the basis of contents of the reply submitted by the firm and keeping in view their
historical background he recommended:
1. That in the light of test report and reply it seems manufacturer specifications were
to be adopted while performing the test. M/s Akhai Pharmaceuticals uses reference
drugs for GSK Pakistan and these specifications are given to them by GSK
Pakistan in which range of pH of Stiemazol lotion is set from 7 to 10. The
specification has been submitted by stiefel/GSK at the time of registration in 1999
and at the time of grant of toll/contract manufacturing permission in 2010 as well
as at the time of renewal of contract manufacturing permission in June 2015. It is
also clearly mentioned on the pack GSK specification.
2. According to scientific justification, it is better to have the pH of Clotrimazole

lotion on basic side which is 7 to 10 and is for tropic al use. This product is stable
within this range which has been confirmed from the stability studies conducted by
the firm.
Names of the technical persons:-
1. Asif Aziz Akhai s/o abdul Aziz Akhair, The Director

2. Muhammad Arif s/o Muhammad Shamim, Quality Control Incharge
3. Shahid Ali Khan s/o safdar Ali Khan, Production incharge
The FID forwarded the case in pursuance of Section 19(7) of Drugs Act 1976. They were called
for personal hearing.
Proceedings and Decision of 270th Meeting:
Ms. Shama Hassan Quality Control Head appeared before the Board and pleaded their
case. She informed the Board that they have agreement with GSK due to Toll manufacturing, our
product follow the GSK specification. She informed that these specs are submitted to the Ministry
by stiefel/GSK at the time of registration in 1999 and at the time of grant of toll/contract
manufacturing permission in 2010 as well as at the time of renewal of contract manufacturing
permission in June 2015. It is also clearly mentioned on the pack GSK specification.
Decision: “The Board after detailed discussion, deliberation, considering the facts and legal
provision decided to further investigate the matter from GSK and confirm from
USP-39.”
Current Status of the Case:
As per decision of DRB in its 270th Meeting, letter with subsequent reminder dated 13-07-
2017 & 16-03-2018 was issued to Area FID, Quetta at Karachi, but no response has been received
till to date.
Decision: The Board after detailed discussion, deliberation, considering the facts and
legal provision decided to further investigate the matter from GSK and
confirm from USP-39 and issue the reminder to the FID for verification of
Testing method.
Case No.3 Manufacture & Sale of Sub-Standard Pyosil 20mg capsule Batch No. C007-17
By M/s UDL pharmaceuticals, Karachi.
The Federal Inspector of Drugs FID-VII, Karachi, on 23-08-2017, drew sample of
Pyosil 20mg Capsule Batch No. C007-17, manufactured by M/s UDL Pharmaceuticals, Karachi
from manufacturer‘s premises for test/analysis. The sample was declared substandard by the F.G
Analyst vide Test Report No.KQ.448/2017 dated 29-10-2017. The remarks of Government
Analyst, CDL, Karachi are as under:-
Dissolution Test: Does not comply
Remarks: - The sample is of “Sub-Standard” quality under the Drugs Act 1976.
In response to FID explanation letter the firm accepted that dissolution test does not
comply with USP specification. The FID recommended that, the registration of the product may
be suspended or cancelled as per section42 under the provision of Drugs Act 1976 and rules
framed there under.
As per procedure show cause notices were issued to the firm on 06-03-2018 to the accused
persons, offering opportunity of personal hearing before the Drug Registration Board. They have
been called for personal hearing.
Proceedings of 281st Meeting of DRB:
Mr. Haroon Dougal, legal expert of M/s UDL Pharmaceuticals, Karachi appeared before
the Board and accepted the substandard report of the subject drug and explained that the
dissolution test does not comply. The Board after deliberation decided as under:-
Decision: Registration Board after deliberation decided as follows:

i. To suspend the Registration for six months or till the verification of
root cause analysis report and corrective and preventive actions by the
firm.
ii. The PSI will be conducted after the submission of above mentioned
report by the firm for physical verification by the panel, constituted by
the Board including the following members:-
i. Dr. Rafeeq Alam Khan, Member, Registration Board.
ii. Director CDL Karachi.
iii. Area FID
iii. The sample of the products shall taken for test /analysis by the CDL
iv. Destruction of 9464 packs of the recalled product by the panel
Case no. 4 Manufacture & Sale Of Adulterated & Sub-Standard “Oxytocin Injection (for
vetonly)”Batch No. 2876 Manufactured By M/S. Elko Organization Pvt, Ltd,
Karachi.
The matter of Adulterated and Substandard Oxytocin Injection Batch no 2876

manufactured by M/s Elko organization, Karachi, by CDL, Karachi vide report no. KQ.
461/2014(B) dated 26th November, 2014, was placed before the Registration Board in its 248th
meeting and RB decided as under:
I. Suspended the registration of oxytocin injection, registration no. 011122 of M/s
Elko Organization (Pvt), Ltd, Karachi for a peroid of six months.
II. Investigation through a Product Specific inspection (PSI) by a panel comprising
of director DTL Quetta, Chief Drug Inspector, Sindh and Area FID karachi.
III. The panel will also witness the destruction of the recalled/withheld stocks of the
drug under reference.
That the letter regarding PSI was conveyed to panel members vide letter no. 3-56/2014-
QC dated 22nd April, 2015. It was requested to conduct PSI by the panel members as under:
I. Dr. Amanullah Khan, Director, Drug Testing Laboratory, Quetta.
II. Syed Kalb-e- Hasan Rizvi, Chief Drug Inspector, Sindh.
III. Abdul Rasool sheikh, Area FID, Karachi.
That the reminders were issued to Additional Director, DRAP, Karachi to conduct PSI and
submit the report by panel vide letter no. 3-56/2014-QC dated 9th October, and 26th October, 2017.
PSI report received from Additional Director, DRAP, Karachi vide F. no. 01-04/2017-
DRAP(K)(Insp) dated 15th November, 2017 received on 23rd November, 2017 wherein he
enclosed the detailed PSI report (duly signed) conducted by panel vide f. ARS.000245/2015-FID-
III(k) dated 15th November, 2017.The panel members are as under:
I. Dr. Amanullah Khan, Director, Drug Testing Laboratory, Quetta.
II. Syed Kalb-e- Hasan Rizvi, Chief Drug Inspector, Sindh.
III. Abdul Rasool sheikh, Area FID, Karachi.
That the following points in the report submitted by Additional Director, DRAP, Karachi are as
under:
 Good practices in production: The root cause of failure was rubber stoppers
which was not washed properly as rubber stoppers were being washed manually.
Factors triggering such incidents were reviewed in detail. Keeping in view the
instant failure stringent checking was found in place to avoid the occurance and
recurrence of such failures in future.
 QA system: with respect to the subject case their SOPS regarding failures and
controlling the deviation were reviewed in detail. After receiving the report the
firm had started to find out the root cause of the problem and total three batches
were also investigated. The firm was found capable enough to investigate their
failures as per SOPs. Appropriate in process checks were noted in place.
That the conclusion of the report submitted by panel is reproduced as under:
After investigating the root cause analysis (RCA) of the failure and subsequent
rectification of the problem the firm had resumed the manufacturing of oxytocin
injection after the lapse of suspension period and keeping in view the current status
of their compliance the panel recommends that the firm may be allowed to
continue the manufacturing of oxytocin injection. The panel further observed that
the retained stocks in quarantine were destructed as per their appr oved SOP on
01.11.2016.
 Meanwhile, it is pertinent to mention that FIA Karachi is conducting enquiry 22/2017
on the complaint of Provincial Inspector of Drugs, Karachi about illegal import of
oxytocin and manufacturing of oxytocin injections manufactured by M/s Elko
organization, Karachi during suspension period. The FIA raised the following queries
in this respect as under:
I. Copies of minutes of meeting of 248th Drug Registration Board where

registration no. 011122 of M/s Elko organization Pvt ltd was suspended.
II. Import details of oxytocin by M/s Elko Organization during 2015 to till date.
III. Procedure/ DRAP regulations to import oxytocin (in any form) into Pakistan
by manufacturers of oxytocin for human and Vetanry usage.
IV. Details of importers viz name of company, quantity imported, etc.
V. Details of any ban imposed on manufacturing or importing (in any form) of
oxytocin by DRAP.
Similarly, NAB is also conducting an enquiry.
Proceeding and Decision of 278th Meeting of Registration Board:

Product Specific Inspection report and import data forwarded by AD (I&E) DRAP Karachi
about import of oxytocine raw material was contained by the DRB and discussed in details.
 The queries of the FIA Karachi and NAB were also brought in the knowledge of the Board
members. The DRB after through deliberation decided as under:-
 That the company violated the orders of the DRB, statutory body and continued import of
raw material during the suspension period as per detail are given below.
 The company resumed production of oxytocin vials without approval of the DRB.
 The Board decided to issue show cause notice & personal hearing letter to the firm for
their violation in the forthcoming meeting.
 It was also decided that the Registration of the oxytocin shall remain suspended till final
decision by the DRB in the forthcoming meeting.
 Registration Board advised PE&R Division to present the case regarding alleged use of
oxytocin vials for enhancement of milk production in the animals.
The Board decided to issue show cause notices of multidose vials on the same lines which have
been adopted by India. They allow only one ml oxytocin ampoule for human use only.
Proceeding and Decision of 281st meeting of Registration Board:

Representatives of the M/s Elko appear before the Registration Board and
stated that M/s Elko did not manufactured oxytocin vials whose registration was
suspended by the Registration Board. They manufactured 1cc injection of oxytocin
which was also registered by the Registration Board. They further contented that
after the expiry of suspension period they were legally authorized are manufacturing
of oxytocin vials. DRB member law also opined that after the expiry of suspension
period, the bar on the company is automatically revoked. Registration Board after
detailed deliberations and discussion constituted a Committee comprising of (Dr. Saif
ur Rehman Khattak Director CDL Karachi and Additional Director Karachi) to
investigate following issues:-
1. It shall be verified whether API of oxytocin vial for veterinary use and
oxytocin ampules for human use is of same specification as per their
registration letters issued by the DRAP and cleared by the Karachi
DRAP office during the suspension period.
2. The Quantity of oxytocin vials and oxytocin ampules manufactured,
sold and distributed during suspension period should be verified by the
Committee after evaluation of manufacturing data of oxytocin vials
and ampules from the manufacturing and distribution records.
Random verification should also be obtained from the distributors etc.
past manufacturing trend of the oxytocin ampules may also be taken
into account while evaluating the manufacturing of oxytocin ampules
and vials during the suspension period
3. The Committee should submit its conclusive report for consideration of
the Board with candid opinion whether M/s Elko conducted
manufacturing of oxytocin vials during the suspension period of six
months or not. It shall also be verified that the firm import of raw
material was on the basis of oxytocin vials or oxytocin ampules
registrations.
4. Decision of cancellation of registration of Oxytocin vial in the light of
show cause notice issued to the firm will be taken after the receipt of
committee report.
Case No. 5 Manufacturing and Sale of Substandard Fero-D Injection Batch No.002 By
M/s Medisure Laboratories Pakistan (Pvt) Ltd Karachi.
The sample of Fero-D Injection Batch No.002 by M/s Medisure Laboratories Pakistan
(Pvt) Ltd Karachi taken by FID Hyderabad at Karachi on 13th June 2014 from manufacturer‘s
premises was declared substandard by FGA, CDL, Karachi vide test report No.KQ.316/2014
dated 08th August 2014. The firm did not challenge the CDL test report in the Appellate Lab NIH
Islamabad. The Cholecalciferol was declared out of specifications i.e does not comply the
specifications.
Assay for: Determined Stated Percentage
Amount/15ml Amount/15ml:
Cholecalciferol 0.92495mg 5.0mg 18.499%
Limits: 90.0% to 110.0% Does not comply

Bacterial Sterility Test: Does not comply.
Remarks: The sample is substandard quality under the Drug Act 1976.
The FID served an explanation letter dated 25th February 2015 to the firm, but the firm did
not reply till to date.
The Show cause notice was issued to the firm from Quality Control Section DRAP,
Islamabad on 2nd January 2017, however the firm submitted their reply on 17th January 2017
wherein the firm enclosed a letter issued to the than FID regarding the Appellate testing of the
sample under section 22 of the Drugs Act 1976, dated 12-09-2014. According to record of Quality
Control Section there is no such letter received till to date.
The accused persons of the firm called for personal hearing.
Proceedings of 265th meeting of RB:

Mr. Atta Dastagir Regulatory Affairs Manager of the firm M/s Medisure Laboratories
Karachi appeared before the Board for personal hearing. The Registration Board asked him to
explain the reason for manufacturing of substandard and non-sterile injection, furthermore the
Board also asked whether any investigation was carried out by the firm to investigate the matter,
Mr. Atta Dastagir failed to reply. He informed the Board that FID issued explanation letter to the
firm on 15th August 2014 and reminder was issued on 11th September 2014. In response to
reminder the firm challenged the report of the Government Analyst dated 12-09-2014, however
the sample could not be retested. The Deputy Director QA informed the Board that the said letter
dated 12-09-2014 is not available in the record of QC Section and even has not been forwarded by
the FID.
Decision of 265th meeting of RB:

After thorough discussion considering all the provisions and considering the facts and
legal provision and claim of the firm that request for appellate testing was given to the FID
Karachi. The Board has decided to get verification from the FID regarding the claim of the firm in
its letter dated 12-09-2014.
Current status of the case:

As per decision of the Registration Board, the FID Hyderabad at Karachi was issued a
letter dated 15th February, 2017 to verify the claim of the firm in its letter dated 12-09-2014
regarding the appeal of the firm for Appellate Testing. The FID Hyderabad at Karachi vide his
letter No. F.NS 37-42/2015-FID (H) dated 18th February, 2017 send a letter in which he verified
that there is no record available of the claimed letter.
Proceedings of Registration Board:

Ms. Nazia Tauseef Regulatory Affairs Manager of the firm appeared before the Board and
pleaded their case. She informed that they have timely provided all the responses against the CDL
test report. They have tested the same batch and passed all the tests. She further informed that the
firm has timely submitted the appeal for Appellate testing in Appellate Laboratory, NIH,
Islamabad.
Decision: “The Board after detailed discussion, deliberation, considering the facts and legal
provision decided to send the copy of claimed letter of the Firm, for Appellate
testing, to Area FID Karachi for reconfirmation of the available record of the
claimed letter.”
Current Status of the Case:

As per procedure of Registration Board, the concerned FID was issued letter for the
implementation of Board decision but no response has been received till to date.
Decision: The Board decided to defer the case to be discussed in forthcoming meeting as
representatives of the firm could not appeared in the meeting.
Case No.6 Manufacture & Sale of Sub-Standard Genticyn HC Ear Drops, By M/S Ray
Pharma (Pvt) Ltd., Karachi.
The samples of Genticyn HC Ear Drops, by M/S Ray Pharma (Pvt) Ltd., Karachi taken by
Provincial drug inspector, Karachi on 09-01-2018 has been declared Substandard by Federal
Government Analyst, CDL, Karachi.
2. The details of all batches are given below:-
Sr. Drug Name Batch Substandard Report, Test Analysis Report

No. No. Failed on Assay Basis No.
(Hydrocartisone)
1. Genticyn HC Ear B014 50.1% PPH.66/2018
Drops
2. -do- B015 56.2% PPH.67/2018
3. -do- B016 85.7% PPH.68/2018
4. -do- B018 86.6% PPH.70/2018
5. -do- B019 87.5% PPH.71/2018
6. -do- B020 59.8% PPH.72/2018
7. -do- B21 66.2% PPH.73/2018
8. -do- B22 67.2% PPH.74/2018
9. -do- B23 56.8% PPH.75/2018
10. -do- B24 42.9% PPH.76/2018
11. -do- B25 79.1% PPH.77/2018
12. -do- B017 Standard Quality PPH.69/2018
It is evident from the above table that 11 batches of the subject product failed due to Assay
content and declared substandard, which is alarming and could not be allowed. The samples was
taken by the provincial Inspector of Drug Karach. The Firm have been called for personal hearing
Proceedings and Decision of 281st Meeting of Registration Board:
Some of the members pointed out that as the samples were taken by the Provincial
Inspector of Sindh Government and it does not fall under the jurisdiction of DRB.
The QA/LT Division presented the case before the Board that out of 12 samples 11
samples of different batches have been declared substandard on the basis of assay
content. The Registration holder is under obligation through the conditions of
registration to ensure quality of the manufactured products. Similarly QA/LT
Division is responsible for the GMP enforcement and post marketing surveillance.
Hence, Registration Board has been interested with the powers to enforce conditions
of registration. Registration Board after throng deliberations decided to adjourned
the case in the upcoming meeting and it was advised to the QA/LT Division to
present comprehensive case for consideration of the Registration Board after
thorough evaluation
Case No. 7 Notification of out of specification (OOS) and out of expectation (OOE) in
Sancose Syp 120ml in Batches.
The case is about the Sancos Syrup 120 mL manufactured by M/s Novartis Pharma, Karachi.The
firm has informed about their 5 batches of Sancos Syrup 120 mL Out of Specs, (OOS) which were
observed in assay content of Phalcodeine during routine Follow Up Stability Testing Study (FUST) after
24 months at 30 °C/65%RH storage condition while 2 batches, which were observed with Out of
Expectation (OOE) in Assay content of Phalcodine during long term stability study after 12 months at 30
°C/65%RH storage condition.
List of OOS batches:

S.No: B.NO: Mfg Date Exp Date Testing Storage Results Limit
Period condition
1 J1605 Oct 2015 Sep 2018 24 months 30 °C/65%RH 85.3% 90 – 110% of
2 J1639 Oct 2015 Sep 2018 24 months 30 °C/65%RH 82.89% the content
3 J1640 Oct 2015 Sep 2018 24 months 30 °C/65%RH 87.69% declared
4 J1641 Oct 2015 Sep 2018 24 months 30 °C/65%RH 86.71%
5 J1485 July 2015 June 2018 24 months 30 °C/65%RH 88.5%
List of OOE batches:
S.No: B.NO: Mfg Date Exp Date Testing Storage Results Limit
Period condition
1 J1759 Sep 2016 Aug 2019 12 months 30 °C/65%RH 94.25% 90 – 110% of
2 J1778 Sep 2016 Aug 2019 12 months 30 °C/65%RH 93.74% the content
declared
The firm informed that their technical and medical experts initiated the investigation to establish
the root cause and effective corrective and preventive action to remediate any potential and after careful
review of cases and trend analysis for lack of efficacy in the Novartis database and literature, there was no
evidence found which adversely affects the safety profile of the patients treated with above mentioned
batches of Sancos syrup. The firm further submitted that based on their present evaluation, the medical risk
to patient is minimal and is unlikely to constitute a safety concern.
A letter was issued to M/s Novartis Pharma Pakistan to recall the above mentioned batches from
the market and the Sancos syrup contains the controlled substances so complete recall must be maintained.
Then, a letter was received from M/s Novartis Pharma Karachi vide letter No. nil dated 01-03-18
received on 06-03-2018 in response to letter issued regarding the recall of Sancos syrup 120 mL for 5
different batches. The firm has submitted that their technical and medical experts initiated the investigation
to establish the root cause and effective corrective and preventive action to remediate any potential and
after careful review of cases and trend analysis for lack of efficacy in the Novartis database and literature,
there was no evidence found which adversely affects the safety profile of the patients treated with above
mentioned batches of Sancos syrup.
The firm further submitted that based on their present evaluation, the medical risk to patient is
minimal and is unlikely to constitute a safety concern. The firm has issued recall letters to Health Care
professionals (Doctors, Chemists, Retailers, Pharmacists, and wholesalers) and the firm has also liaised
with their Stakeholders, distributors, GSK team and other relevant stakeholders to ensure effectiveness of
the recall.
The firm has also submitted the detailed Deviation Investigation Report generated by the
manufacturing site. The detail of Executive Summary is given below:-
Routine FUST stability test of Sancos syrup 120mL batch number J1605, J1639, J1640 and J1641 Oos was
observed in Pholcodine assay result on 24th Monthafter manufacturing (product has 36 months shelf life).
Assay result of Pholcodine was recordrd as 82.3%, 83.77%, 84.8% & 84.4% respectively. This initials
assay result of Pholcodine at zero-month test point were 99.17%, 100.47%, 101.24% & 101.75% & also in
two batches J1759 & J1778 OOE in assay result of Pholcodine observed after 12 months for long term
stability testing i.e. 94.25% and 93.74% respectively.
As an immediate action(s) were taken and the retension samples of these batches were tested and
the assay result was found satisfactory i.e. 94.58%, 95.85%, 95.62% & 95.32%. escaltated the issue to
Novartis team, as the Market authorization of this product is still with Novartis.
OOS result of assay may have impact on patient safety, therefore, this is categorized as Major
Deviation. For Root cause analysis of this OOS cross functional team aws formed consisting of Lead
Deviation Investigator, Production Manager, Stability Lead and Head of Compliance. Investigation Plan
was prepared which included documentation review, Gemba walk, Timeline, Fish bone diagram, impact
assessment and CAPA identification.
To investigate the OOS in Sancos Syrup 120mL B.No. J1605, J1639, J1640 and J1641, & OOE in
Sancos Syrup 120mL J1759 & J1778 batche documents were reviewed, record showed that , the batch
mnufacturing and packaging process was carried as per procedure, Manufacturing instruction & record and
packaging process was carried out as per the Packing Instruction and Record (P.I). All the process,
dispensing, Manufacturing, filling and packaging was performed accordingly. No deviation was observed
in the process. All manufacturing and packaging process was carried out accordingly.
During investigation it is identified that Pholcodine in this product is unstable at 30°C/65%RH, but
could not be detected earlier because the previous stability studies (before 2015) were carried out in the
samples which were not placed in firm controlled and monitored temperature of 30°C/65%RH. Due to
unavailability of stability chamber of 30°C/65%RH, to maintain the stability condition, samples were
placed in air controlled room of 30°C. As these air conditioned rooms were not continously monitored,
therefore; it is likely that the temperature of room was remained below 30 °C. The stability trend of this
product showed that this product is stable at 25°C, therefore, due to flexible storage condition, the stability
data showed satisfactory result at that time points. Once these stability samples placed in strict
30°C/65%RH, environment in 2015, Oos results were detected. As the samples placed in controlled
stability condition chamber, two batches showed the OOE in batch number J1778 & J1759 in long-term
stability.
On the basis of above data and analysis, it is concluded that product formulation seems to be
unstable at 30°C/65%RH and cannot withstand with 36 months shelf life.
Recommendation by the Quality Control Section:-
It is submitted that Pholcodine is not stable above 25c which is revealed from the data of M/s Novartis
Pharma. It was also stated that its shelf life may be 18th months at 25c. it is therefore recommended that all
product formulations should be treated as under:-
1. Shelf life of the product should be reduced upto 18 months.
2. Storage condition ―store below 25°C‖ should be mentioned on label.
3. In future, first three batches of this product should be placed in accelerated stability
studies
Decision: Registration Board considered the case of the M/s Novartis regarding
the recall of out of specifications and out of expectations results of
Sancos syrup manufactured by Novartis Pharma. The report of FID
was also considered. Registration Board deferred the case for
evaluation by the QA/LT Division after obtaining details of the
manufactured batches and recalled quantity of the Sancos syrup from
the manufacture and area FID.
Item No. VI Additional Agenda
Case No.1 Fixation/approval of multiple sources of pellets/granules/bulk liquid.
Matter regarding fixation/approval of multiple sources of pellets/granules/bulk liquid has

been deliberated, as follows:
i) Consideration of pellets as half-finished drug.

ii) Approval of multiple sources for pellets.
iii) Already approved sources by DRAP should be notified and firms may be allowed to
opt any of these sources.
Decision: Registration Board deliberated that as per Drugs (Licensing, Registering and
Labeling) Rules, 1976, pellets/granules/bulk liquid are being considered as “Half-finished
product” means any material or mixture of materials that has to undergo further
manufacture.
The Board decided to approve three sources of pellets/granules/bulk liquid etc for
manufacturing of registered drug products subject to submission / fulfilment of following:
 Firm shall provide GMP certificate, COA and stability data as per Zone IVA by
manufacturer of pellets/granules/bulk liquid etc.
 Manufacturer shall perform pharmaceutical product development and stability studies,
validation of manufacturing process and method of analysis before sale of drug
product.
 For additional sources of pellets/granules/bulk liquid (for products where PSI is
required ); the process of approval shall remain the same as for initial registration.
A. Pharmaceutical Evaluation Cell
In addition to routine agenda, the following was discussed and decided as under;
Representatives of PCDA and Pharma Bureau pointed out regarding expiry of original
legalized Certificate of Pharmaceutical Products (CoPP)/ Free Sale Certificate (FSC) during the
process of registation. The Board reviewed its earlier decision and decided to consider such
applications whose legalized CoPPs are valid at the time of submission of application. However,
the applicant (s) shall also provide original, legalized valid CoPP before issuance of registration
letter. The registration shall be processed after approval of Chairam, Registration Board.
Case No. 2 Routine Applications of Human Drugs

Evaluator PEC-II
1. Name and address of manufacturer / M/s GT Pharma (Pvt) Ltd, Plot No. 713, Punjab Industrial
Applicant Estate, Sunder Industrial Estate, Lahore.
Brand Name +Dosage Form + Strength Myoprin-SR 30mg Capsule
Cyclobenzaprin HCl (as SR pellets) ……. 30mg
Source of pellets: M/s Vision Pharmaceuticals,
Islamabad
Pharmacological Group Muscle relaxant and cholinesterase inhibitor
Type of Form Form-5
Approval status of product in Reference Amrix extended release capsule of Teva Pharms intl,
Regulatory Authorities. approved by USFDA
Me-too status Emrix-SR 30mg capsule of M/s Getz Pharma (Reg.#
070451)
GMP status Latest GMP inspection report conducted on 08-08-2017
and report concludes GMP compliance status
Decision: Approved
2. Name and address of manufacturer / M/s Jaskan Pharmaceuticals Industries Pvt Ltd., Plot No.
Applicant 50, Punjab Industrial Estate, Sunder, Lahore.
Brand Name +Dosage Form + Strength Amsart 10/160mg Tablet
Amlodipine as besylate………..10mg
Valsartan……………..160mg
Type of Form Form-5
Regulatory Authorities. EXFORGE (NOVARTIS)
Me-too status Co-Valzaar 10mg/160mg Tablet of Vision
Pharmaceuticals.
GMP status Copy of inspection report conducted on 13-03-2018, to
check the improvement done by firm. The report
concludes as under:
―Keeping in view the compliance submitted by the firm
and the inspection conducted by the panel the resumption
of production to M/s Jaskan Pharmaceuticals (Pvt.) Ltd.,
Lahore is recommended.‖
Remarks of the Evaluator. ● Two different product names are mentioned on
original fee challan, as under:
i. Tab Dufaskan 10mg
ii. Amsart 10-160mg
Decision: Registration Board approved the applied formulation, considering the fact that a
separate fee challan is available for the second product mentioned on fee challan i.e. Dufaskan
10mg tablet
Brand Name +Dosage Form + Strength Jablin Capsule 50mg
Pregabalin ................50mg
Diary No. Date of R& I & fee Dy. No. 123, 03-08-2016 Rs. 20,000/- (03-08-2016)
Type of Form Form-5
Finished product Specification Manufacutrer specifiction
concludes as under:
Brand Name +Dosage Form + Strength Jablin Capsule 75mg
Pregabalin ................75mg
Type of Form Form-5
concludes as under:
Brand Name +Dosage Form + Strength Jasitamet 50/1000mg Tablet
Metformin HCl ………… 1000mg
Sitagliptin as phosphate monohydrate …… 50mg
Pharmacological Group Anti-diabetic agent and oral hypoglycemic
Type of Form Form-5
Me-too status Sitamet tablet by M/s CCL Pharmaceuticals Pvt. Ltd.
concludes as under:
i. Jasitamet 50/100mg
ii. Tab Amsart 5/80mg
separate fee challan is available for the second product mentioned on fee challan i.e. Amsart
5/80mg tablet
Brand Name +Dosage Form + Strength Jasitamet 50/500mg Tablet
Metformin HCl ………… 500mg
Sitagliptin as phosphate monohydrate …… 50mg
Pharmacological Group Anti-diabetic agent and oral hypoglycemic
Type of Form Form-5
Me-too status Sitamet tablet by M/s CCL Pharmaceuticals Pvt. Ltd.
concludes as under:
ii. Jasitamet 50/1000mg
separate fee challan is available for the second product mentioned on fee challan i.e. Jasitamet
50/1000mg tablet
Brand Name +Dosage Form + Strength Dufaskan Tablet 10mg
Dydrogesterone………….10mg
Diary No. Date of R& I & fee Dy. No.127, 03-08-2016, Rs. 20,000/- (03-08-2016)
Pharmacological Group Progestogen
Type of Form Form-5
Approval status of product in Reference Duphaston by BGP Products (Swissmedic Approved)
Me-too status Duphaston by Abbott (Reg. No. 006654)
concludes as under:
ii. Dufaskan 10mg
Decision: Deferred for deliberation upon Cis/Trans isomer of Dydrogesteron.
Evaluator PEC-XIII
8. Name and address of manufacturer / M/s Z- Jans Pharmaceuticals, 148-A, Industrial Estate,
Applicant Hayatabad, Peshawar
Brand Name + Dosage Form + Strength Alpa- Z tablet 0.5mg
Alprazolam……………………………..….....0.5mg
Pharmacological Group Anxiolytic / Benzodiazepine derivative
Pack size & Demanded Price as per SRO & as per SRO
Approval status of product in Reference Australia (TGA Approved)
Me-too status Xanax tablet 0.5mg of M/s Pfizer Pharmaceuticals
(Reg. # 012303)
GMP status Latest GMP inspection was conducted on 07-11-2017
and the submitted report does not mention any
conclusion.
Remarks of the Evaluator ● The applied dosage form i.e. tablet is not
mentioned on fee- challan and strength is being
overwritten as 0.5mg above 0.25mg under
deposit slip # 0569580.
● Submitted GMP inspection report does not
mention any conclusion.
● Firm has psychotropic section.
● Updated status of GMP of the firm from QA & LT division as inspection report
● Clarification of fees from Budgets and Accounts Division against the applied dosage form
and strength.
Brand Name + Dosage Form + Strength Oprime capsule 40mg
Composition Each capsule (enteric-coated pellets) contains:
Omeprazole ........................................................40mg
Type of Form Form-5
Pack size & Demanded Price 1x10‘s, 2x7‘s & as per SRO
Me-too status Omezol 40mg capsule of M/s Bosch Pharmaceuticals
(Reg. # 029002)
and the report concludes satisfactory level of GMP
compliance.
Remarks of the Evaluator ● Source of pellets is M/s Vision
Pharmaceuticals.
● GMP certificate of the manufacturer is valid
upto 25-01-2019.
● Stability data of pellets has been provided by
the firm.
Decision: Approved
10. Name and address of manufacturer / M/s Indus Pharma (Pvt) limited, Plot No. 26-27 & 63-
Applicant 67, Sector-27, Korangi Industrial Area, Karachi
Brand Name + Dosage Form + Strength Parazol Solution for Infusion 10mg/ ml
Composition Each ml vial contains:
Paracetamol……………………………..….10mg
Pharmacological Group Analgesic and Antipyretic
Type of Form Form-5
Pack size & Demanded Price 100ml & as per PRC
Me-too status Falgan 1G/100ml Infusion of M/s Bosch Pharma
(Reg. # 055540)
the report concludes an acceptable level of GMP
compliance.
Remarks of the Evaluator ● The applied formulation is non-
pharmacopoeial.
Decision: Approved
11. Name and address of manufacturer / M/s Welmark Pharmaceuticals, Plot # 122, Block-B,
Applicant Phase-V, Industrial Estate, Hattar, NWFP
Brand Name + Dosage Form + Strength Savelawel tablet 400mg
Sevelamer HCl………………………………400mg
Pharmacological Group Drugs for treatment of Hyperkalemia and
Hyperphosphatemia
Finished product Specification Manufacturers specifications
Pack size & Demanded Price 2 x 7‘s & as per SRO
Me-too status Renavel 400mg tablet of M/s Genome Pharmaceuticals
(Reg. # 059407)
and the report concludes the firm to be GMP compliant.
Remarks of the Evaluator ● The applied formulation is non-
pharmacopoeial.
Decision: Approved
Brand Name + Dosage Form + Strength Welsetron capsule 5mg
Tropisetron as Hydrochloride.…………………5mg
Pharmacological Group Antiemetics & Antinauseants
Pack size & Demanded Price as per SRO & as per SRO
Approval status of product in Reference Navoban capsules 5mg of M/s Orifam AB (Approved in
Regulatory Authorities Sweden)
Me-too status Navoban capsules 5mg of M/s Novartis
Pharmaceuticals (Reg. # 014058)
Remarks of the Evaluator The applied formulation is non-pharmacopoeial.
Decision: Approved
Brand Name + Dosage Form + Strength Weldronic 3mg/3ml injection
Ibandronic acid Monosodium Monohydrate eq. to
Ibandronic acid ……………………...……....3mg
Pharmacological Group Hormones and other endocrine drugs and contraceptives
Me-too status Adronil 3mg/ 3ml injection of M/s Searle Pakistan
Remarks of the Evaluator ● Firm has applied pharmacological group as
Hormones and other endocrine drugs and
contraceptives while it is bisphosphonate (drug
affecting bone structure and mineralization).
● The applied formulation is non-pharmacopoeial.
Decision: Deferred for clarification of applied pharmacological group.
Brand Name + Dosage Form + Strength Welsetron injection 5mg/5ml
Tropisetron HCl eq. to Tropisetron……5mg
Pharmacological Group Antiemetics and antinauseants
Approval status of product in Reference TGA Australia Approved
Me-too status Navoban of M/s Novartis Pharma
(Reg. # 014059)
Remarks of the Evaluator The applied formulation is non-pharmacopoeial.
Decision: Approved
15. Name and address of manufacturer / M/s S.J. & G Fazul Ellahie (Pvt) limited, E-46, S.I.T.E.,
Applicant Karachi
Brand Name + Dosage Form + Strength Zeclar ER tablet 500mg
Composition Each extended-release tablet contains:
Clarithromycin ........................500mg
Pharmacological Group Antibacterial (Macrolide)
Pack size & Demanded Price 5‘s, 14‘s & as per PRC
Approval status of product in Reference Klaricid of M/s Mylan Products limited (MHRA
Me-too status Klaricid XL of M/s Abbott Laboratories, Pak
the report does not mention any conclusion.
Remarks of the Evaluator ● 5% overage needs justification.
● GMP inspection report does not mention any
conclusion.
● Updated status of GMP of the firm from QA & LT division as inspection report
● Justification of 5% overage addition in the master formulation.
Applicant Karachi
Brand Name + Dosage Form + Strength Colinor Suspension 250mg/ 5ml
Ursodeoxycholic Acid.....................................250mg
Pharmacological Group Bile-acid , treatment of gallstones
Finished product Specification BP specifications
Pack size & Demanded Price 60ml, 120ml & as per PRC
Approval status of product in Reference (MHRA Approved)
Me-too status Urso Suspension 250mg/ 5ml of M/s AGP Laboratories
Remarks of the Evaluator ● GMP inspection report does not mention any
conclusion.
● The firm has applied BP specifications while the
applied drug is non- pharmacopoeial.
Decision: 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.
Applicant Karachi
Brand Name + Dosage Form + Strength Colinor capsules 250mg
Ursodeoxycholic Acid.......................250mg
Pharmacological Group Bile-acid , treatment of gallstones
Finished product Specification BP specifications
Approval status of product in Reference (MHRA Approved)
Me-too status Urso 250mg capsules of M/s AGP Laboratories (Reg. #
015677)
Remarks of the Evaluator GMP inspection report does not mention any
conclusion.
Decision: 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.
Evaluator PEC-VIII
18. Name and address of Manufacturer / M/s Searle Company Limited F-319 SITE Karachi.
Applicant
Brand Name+Dosage Form+Strength Water For Injection
Sterile Water For Injection…5ml
Pharmacological Group Diluent/Solvent
Type of Form Form-5
Finished Product Specification European Pharmacopoeial Specifications
Pack Size & Demanded Price 1‘s,(5ml); As per SRO
Approval status of product in Approved in MHRA
Me-too status Aqua R ampoule by M/s Regal Pharmaceuticals
(Reg#082010)
GMP status Certificate of GMP based on evaluation conducted on 12-06-
2017 valid for a period of one year is issued to the firm.
Remarks of Evaluator Applied formulation is present in USP.
Decision: Approved.
Applicant
Type of Form Form-5
Me-too status Water for injection 10ml by M/s Novamed
(Reg#076972)
2017 valid for a period of one year is issued to the firm
Decision: Approved.
Applicant
Type of Form Form-5
Me-too status Water for injection 2ml of Healthtek
Decision: Approved.
Applicant
Type of Form Form-5
Me-too status Water for injection 1ml of Healthtek
Decision: Approved.
Applicant
Brand Name+Dosage Form+Strength Sodium Chloride 0.9%
Sodium Chloride …45mg
Pharmacological Group Salt solutions
Type of Form Form-5
Approval status of product in WHO recommended formulation
Me-too status Sacro Injection of Macter Intr. Karachi.
Decision: Approved.
23. Name and address of Manufacturer / M/s Sunrise Pharmaceuticals (Pvt.) Limited 594, A Sundar
Applicant Estate, Raiwind Road, Lahore. Contract Manufactured by
Searle IV solutions.
Brand Name+Dosage Form+Strength Macmol IV infusion 1.0g
Paracetamol …....1gm
Diary No. Date of R&I & fee Duplicate dossier; Rs. 20,000/-, 12-06-2017
Type of Form Form-5
Finished Product Specification USP specifications
Pack Size & Demanded Price 1‘s(100ml) ; Rs. 80/-
Me-too status Panam infusion of English Pharma
GMP status GMP Inspection of M/s. Searl IV Solutions conducted on 27-
02-18 shows that firm is GMP compliant.
Decision: Approved.
24. Name and address of Manufacturer / M/s Nawan Laboratories (Pvt.) Ltd. 136, Sector 15, Korangi
Brand Name+Dosage Form+Strength Atrow tablet 10mg
Atorvastatin as (calcium trihydrate) …....10mg
Diary No. Date of R&I & fee Dy No. 3161;18-05-17: Rs. 20,000/-
Pharmacological Group HMG Co-A reductase Inhibitor
Type of Form Form-5
Pack Size & Demanded Price 10‘s; As per DPC
Approval status of product in Approved in US-FDA
Me-too status Torvia 10mg Tablet of PPP Karachi.
GMP status GMP inspection conducted on 26-09-2016 with conclusive
remarks that firm is operating at satisfactory level of GMP
compliance.
Brand Name+Dosage Form+Strength Atrow tablet 20mg
Type of Form Form-5
compliance.
Brand Name+Dosage Form +Strength Atrow tablet 40mg
Type of Form Form-5
compliance.
27. Name and address of manufacturer / M/s. Ray Pharma, S-58, S.I.T.E, Karachi.
Applicant
Brand Name+Dosage Form+Strength Delcina-V 2% cream w/w
Other proposed names:
Del-C
Deltina-V
Veloxi
Composition Each 100gram contains:
Clindamycin (as phosphate)………2gm
Type of Form Form-5
Finished product Specifications USP Specifications.
Pack size & Demanded Price 40gram; Rs. 485/-
Approval status of product in Cleocin (USFDA approved)
Me-too status (with strength and Clindanor 2% cream of M/S Nortech pharmaceuticals
dosage form)
remarks that firm is operating at good level of GMP
compliance.
Decision: Approved.
Applicant
Brand Name+Dosage Form+Strength Sidin 2% cream w/w
Fusidic acid………20mg
Type of Form Form-5
Finished product Specifications Manufacturer‘s Specifications
Pack size & Demanded Price 15gram; Rs. 211.60/-
Reference Regulatory Authorities (Fucidin cream)
Me-too status (with strength and Ucid 2% Cream of M/S Ciba pharma
dosage form)
compliance
Decision: Approved.
Applicant
Brand Name+Dosage Form+Strength Sidin-H 2% cream w/w
Fusidic acid………20mg
Hydrocortisone acetate…10mg
Pharmacological Group Antibacterial, anti-inflammatory
Type of Form Form-5
Finished product Specifications Manufacturer‘s Specifications
Reference Regulatory Authorities (Fucidin-H cream)
Me-too status (with strength and Fusirum-H Cream of M/s Fynk Pharmaceuticals
dosage form)
compliance
Decision: Approved.
Applicant
Brand Name+Dosage Form+Strength Clovir ointment 5% w/w
Composition Each 100 gram contains:
Acyclovir….. 5gm
Type of Form Form-5
Finished product Specifications USP Specifications
Me-too status (with strength and Virolite Ointment 5 % of M/s Pearl Pharmaceuticals
dosage form)
compliance
Decision: Approved.
Applicant
Brand Name+Dosage Form+Strength Lustra Cream 4%, 0.01%, 0.05% w/w
Composition Each 100 gram contains:
Flucinolone acetonide….. 0.01gm(0.01%w/w)
Hydroquinone… 4gm(4%w/w)
Tretinoin… 0.05gm (0.05%)
Type of Form Form-5
Finished product Specifications USP Specifications
Reference Regulatory Authorities (Tri-Luma cream )
Me-too status (with strength and Flutret Cream of M/s Caraway Pharmaceuticals
dosage form)
compliance
Decision: Approved.
Evaluator PEC-XIV
32. Name and address of manufacturer / M/s Medera Pharmaceuticals, Plot No. 249/A, industrial
Applicant Triangle, Kahuta Road, Islamabad.
Brand Name +Dosage Form + Strength Terbex Tablet
Terbinafine as HCl……………..250mg
Type of Form Form-5
Pack size & Demanded Price 10‘s ; As per SRO
Approval status of product in Reference Lamisil tablet of Novartis Pharma, USFDA
Me-too status Funge Tablet of Wilshire (Reg # 038026)
GMP status Inspection conducted on 23-11-2017, the firm M/s
Medera Pharmaceuticals was considered to be operating
at fair compliance with GMP guidelines as per Drugs
Act.
Decision: Approved
Brand Name +Dosage Form + Strength Ormed 120 capsule
Orlistat……………….120mg
Pharmacological Group Gastrointestinal lipase inhibitor
Type of Form Form-5
Pack size & Demanded Price 10‘s, 30‘s ; As per SRO
Approval status of product in Reference Xenical capsules 120mg of Cheplapharm, USFDA
Me-too status Fabecal capsules of highnoon Laboratories (Reg #
042565)
Act.
Brand Name +Dosage Form + Strength Inflaban Tablet
Diclofenac potassium………………50mg
Type of Form Form-5
Pack size & Demanded Price 2 ×10‘s ; As per SRO
Approval status of product in Reference Diclofenac potassium 50 Tablets of Sandoz, USFDA
Me-too status Caflam tablets of Sandoz (Pakistan) ltd (Reg # 021528)
Act.
Decision: Approved with innovator’s specifications and change of brand name
Brand Name +Dosage Form + Strength Levotin Tablet
Levocetirizine 2HCl……………….5mg
Type of Form Form-5
Approval status of product in Reference Xyzal tablet USFDA approved
Me-too status Atiza tablet of Asian continental (Reg # 057850)
Act.
Brand Name +Dosage Form + Strength Medtab Tablet
Memantine HCl……………….10mg
Pharmacological Group NMDA receptor antagonist
Type of Form Form-5
Approval status of product in Reference Namenda Tablet 10mg of Allergan sales, USFDA
Me-too status Rement 10mg tablet of High Q Pharma (Reg # 073885)
Act.
Brand Name +Dosage Form + Strength Telimed 400mg Tablet
Telithromycin……………….400mg
Pharmacological Group Macrolide
Type of Form Form-5
Approval status of product in Reference Ketek tablet of Sanofi Aventis, Discontinued in USFDA
Me-too status Telithro 400mg Tablets of Helix (Reg# 055827)
Act.
Remarks of the Evaluator. Other proposed names:
Eratil 400mg Tablet
Lithromed 400mg Tablet
38. Name and address of manufacturer / M/s Macter International Limited, F-216, S.I.T.E.,
Applicant Karachi
Brand Name +Dosage Form + Strength Inspirol Rotacaps
Salbutamol sulphate………………200mcg
Diary No. Date of R& I & fee 5908, 13-06-2017, 30-05-2017
Pharmacological Group Selective beta2-adrenoreceptor agonist
Type of Form Form-5
Pack size & Demanded Price 30 DPI capsules; As per DPC
Approval status of product in Reference Easyhaler salbutamol 200mcg of orion pharma (EMC)
Me-too status Aerotec 200 capsules of highnoon Labs (Reg # 044593)
GMP status The firm was granted GMP certificate based on
inspection conducted on 07-08-2017 and 17-10-2017.
Evaluator PEC-XI
39. Name and address of manufacturer / M/s Zafa Pharmaceutical Laboratories (Pvt.) Ltd., B-10,
Applicant S.I.T.E., Karachi.
Brand Name +Dosage Form + Strength Piperataz injection 2.25gm
Piperacillin (as sodium)……….……2gm
Tazobactam (as sodium)……….……0.25gm
Diary No. Date of R& I & fee Dy.No.97;10-06-2011;Rs.8,000/-(10-06-2011),
Rs.12,000/-(01-08-2013) Duplicate fee challans attached
Pharmacological Group Penicillin
Type of Form Form-5
Pack size & Demanded Price 1‘s;As per PRC
Me-too status (with strength and Tacip Injection 2.25gm of M/s Macter International
dosage form) (Reg.#081175)
40. Name and address of manufacturer / M/s WnsFeild Pharmaceuticals, Plot No. 122, Phase V,
Applicant Block A, Industrial Estate, Hattar.
Brand Name +Dosage Form + Strength Roxaban 10mg tablet
Rivaroxaban ……….…………10mg
Type of Form Form-5
Pack size & Demanded Price As per SRO; As per policy of MoH
Approval status of product in Xarelto of Janssen Pharm (USFDA Approved)
Me-too status (with strength and Xarelto 10 mg tablet of M/s Bayer
dosage form)
recommending renewal of DML
41. Name and address of manufacturer / M/s WnsFeild Pharmaceuticals, Plot No. 122, Phase V,
Applicant Block A, Industrial Estate, Hattar.
Brand Name +Dosage Form + Strength Wincinol injection
Hydrated pholoroglucinol….......40mg
Trimethylphloroglucinol….........0.04mg
Type of Form Form-5
Pack size & Demanded Price 4ml x 6‘s; As fixed by Govt.
Approval status of product in Spasfon (ANSM Approved)
Me-too status (with strength and Spasfon of M/s Himont
dosage form)
recommending renewal of DML
42. Name and address of manufacturer / M/s Welwrd Pharmaceuticals, Plot No. 3, Block A, Phase
Applicant I-II, Industrial Estate, Hattar.
Brand Name +Dosage Form + Strength Welcinol tablet
Composition Each sugar coated tablet contains:
Hydrated pholoroglucinol…...80 mg eq. to anhydrous
phloroglucinol………………..62.233mg
Trimethylphloroglucinol….........80mg
Type of Form Form-5
Pack size & Demanded Price 30‘s; As fixed by Govt.
Approval status of product in Spasfon tablets (ANSM Approved)
Me-too status (with strength and Spasfon tablets of M/s Himont
dosage form)
report concludes that overall the firm is GMP
compliant.
Remarks of the Evaluator Firm has revised formulation from film coated tablets to
sugar coated tablets and submitted revised master formula
and original fee challan of Rs. 5000/- dated 09-04-2018.
Brand Name +Dosage Form + Strength Welcinol injection
Hydrated pholoroglucinol….......40mg
Trimethylphloroglucinol….........0.04mg
Type of Form Form-5
Pack size & Demanded Price 4ml x 6‘s; As fixed by Govt.
Approval status of product in Spasfon (ANSM Approved)
Me-too status (with strength and Spasfon of M/s Himont
dosage form)
compliant.
Brand Name +Dosage Form + Strength Itowrd 50mg tablets
Itopride hydrochloride….......50mg
Pharmacological Group Gastroprokinetic agent
Type of Form Form-5
Pack size & Demanded Price As per SRO; As fixed by Govt.
Approval status of product in (PMDA approved)
Me-too status (with strength and Ganaton 50 mg tablet by M/s Abbott.
dosage form)
compliant.
Remarks of the Evaluator  Firm has revised formulation from uncoated tablets to
film coated tablets and submitted revised master
formula and original fee challan of Rs. 5000/- dated
09-04-2018.
Decision: Approved
45. Name and address of manufacturer / M/s Indus Pharma (Pvt.) Ltd., plot No.26, 27, 63, 64, 65,
Applicant 66 & 67, Sector-27, Korangi Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Indolact syrup
Lactulose……………….66.7g
Source of API: Lactose India Limited, Survey No. 5&6,
Village-poicha (Rania), Tal-savli, Poicha, India.
Rs.80,000/- (11-12-2017)
Pharmacological Group Laxative
Type of Form Form-5
Pack size & Demanded Price 120ml; Rs.180.00/-
Approval status of product in Reference Duphalac (MHRA approved)
Me-too status (with strength and dosage Duphalac of M/s Abbott
form)
GMP status Latest cGMP inspection report dated 16-08-2017; and the
report concludes that the firm was considered to be
guidelines at the time of inspection.
Remarks of the Evaluator Firm has submitted commercial invoice as an evidence of
RI detector.
Decision: Deferred for review of GMP certificate and stability data of lactulose submitted by
supplier i.e., Lactose India Limited, Survey No. 5&6, Village-poicha (Rania), Tal-savli, Poicha,
India.
Evaluator PEC-III
46. Name and address of manufacturer / M/s Aspin Pharma (Pvt.) Ltd, Plot No. 10&25, Sector 20,
Applicant Korangi Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Eczy Cream
Composition Each gram contains:-
Diflucortolone valerate …1mg (0.1%w/w)
Isoconazole nitrate …10mg (1%w/w)
Pharmacological Group Corticosteroids, potent, combinations with antiseptics
Type of Form Form-5
Pack size & Demanded Price 10gm /As per SRO
Approval status of product in Reference Travocort 0.1 + 1% w/w Cream by M/s Bayer Limited
Regulatory Authorities. (HPRA Ireland Approved)
Me-too status Travocort 0.1 + 1% w/w Cream by M/s Bayer Healthcare
(Reg#005830)
GMP status 18.08.2017
Firm is GMP compliant
Sr.# Name and Brand Name Type of Form Remarks on the Remarks of Decision of 281st
address of (Proprietary name + Initial date, formulation (if Evaluator (if any) meeting of
manufactur Dosage Form + diary any) including Registration
er / Strength) Fee including International Board.
Applicant Composition differential status in
Pharmacological fee stringent drug
Group regulatory
Finished product Demanded agencies /
Specification Price / authorities
Me-too status
Pack size
47. Wilson‘s Cyclone Capsule Form 5 Seromycin ● The initially Deferred for
Pharmaceuti 250mg Dy.No.1608 Capsule by applied submission of fee
cals, 387- Each Capsule 18-01-2011 Purdue formulation as for revision of
388, I-9, contains: PKR 8000/- (USFDA per submitted formulation.
Industrial Cycloserine…..250m (18-01-2011) Approved) Form 5 and
Area, g + 8,000 fee chalan
Islamabad (Broad – Spectrum PKR 12,000/- Cyclosen by was 250mg
Antibiotic) (04-07-2014) Schazoo Zaka tablet, later the
10‘s, 30‘s, firm has
USP Specs 50‘s Last inspection submitted to
As Per SRO dated 24-01-2018 revise the
confirms very formulation to
good level of 250mg capsule.
GMP Firm has also
compliance. submitted
revised
formulation and
Form 5. Fee for
revision of
formulation is
not submitted.
48. Sharooq Solifen Tablet 5mg Form 5 Giraxine 5 mg ● Solif Approved with
Pharma(Pvt)Each film coated Dy. No. 7813 film-coated tablet en 10mg tablet is change of brand
Ltd, 21-Km tablet contains: 20-8-2010 by MEDREICH already name of both 5
Ferozepur Solifenacin PKR 8,000/- PLC registered for and 10mg strength
Road Succinate…….5mg 20-8-2010 (MHRA M/s Shrooq & with Innovators
Lahore (Selective M3 anti + Approved) Pharma in 265th specifications.
muscrinic drug) PKR 12000/- meeting, while
(31-03-2015) Solifen tablet by solifen 5mg
10‘s, 20‘s, Getz Pharma tablet brand has
30‘s been approved
As per SRO 30-08-2017; for M/s Danas
Inspection for Pharma in 264th
Renewal of DML meeting.
Panel
recommends
Renewal of
DML.
49. Welmark Alendromark 70mg Form 5 Fosamax by ● PKR Approved.
Pharmaceuti Tablets Dy No 10 Merck 12,000 fee Reference will be
cals, Plot # Each tablet contains:-1-11-2010 (USFDA chalan needs sent to Budget &
122-B, Alendronate (as PKR 8000/- Approved) verification. Accounts Division
Phase-V, Sodium)…..70mg (1-11-2010) for verification of
Industrial (Bisphosphonate) + Fosamax by challan and Board
Estate, PKR 12,000/- Muller & Phipps authorized its
Hattar USP Specs 31-10-2014 Chairman for the
(Duplicate) Last inspection issuance of
10‘s report dated 16-9- registration letter.
30‘s 2017confirms
As Per SRO that the firm was
GMP compliant.
50. Welmark Penmark 40mg Form 5 Could not be ● This Registration
Pharmaceuti Capsules Dy No. 4 confirmed formulation has Board rejected the
cals, Plot # Each capsule 1-11-2010 been discussed application since
122-B, contains:- Rs.8000/- Pensodin capsule in review in this formulation is
Phase-V, Pantoprazole (1-11-2010) by webrose 250th meeting not approved by
Industrial …..40mg + pharma and the Board any reference
Estate, (Proton Pump Rs.12,000/- advised the regulatory
Hattar Inhibitor) (31-10-2014) Last inspection firms to change authority
14‘s report dated 16-9- this formulation
As Per SRO 2017confirms to tablet dosage
that the firm was form as per
GMP compliant. reference
products. The
firm has already
applied for
pantoprazole
tablet and that
product is
deferred in
275th meeting.
51. Munawar Brufinac Suspnesion Form 5 Ibuprofen/Pseudo● Both fee chalan Approved with
Pharma Each 5ml contains:- 11-11-2010 ephedrine needs verification change of brand
(Pvt) Ltd., Ibuprofen…….100 (DUPLICATE hydrochloride from budget and name & with
31 Km, mg DOSSIER) 100 mg/15 mg account division. Innovators
Ferozepur Psedoephedrine PKR 8,000/- per 5 ml Oral specifications.
Road, HCl……….15mg (11-11-2010) Suspension by Reference will be
Lahore (Non-Narcotic (Duplicate) Aventis Pharma sent to Budget &
Analgesics/ + (MHRA Accounts Division
Sympathomimetic) PKR 12,000/- Approved) for verification of
(28-11-2014) challan and Board
(DUPLICATE) Arinac authorized its
60ml: Rs. 29/- Suspension by Chairman for the
Abbott issuance of
GMP certificate
issued based on
the inspection
dated 7-11-2017
52. Munawar Artelum 20/120 Form 5 WHO approved ● Both fee chalan Approved.
Pharma Tablets 11-11-2010 formulation needs verification Reference will be
(Pvt) Ltd., Each tablet (DUPLICATE from budget and sent to Budget &
31 Km, contains:- DOSSIER) Artem Plus account division. Accounts Division
Ferozepur Artemether…20mg PKR 8,000/- Tablets by Hilton for verification of
Road, Lumefantrine……12 (11-11-2010) challan and Board
Lahore 0mg (Duplicate) GMP certificate authorized its
(Anti-malarial) + issued based on Chairman for the
PKR 12,000/- the inspection issuance of
International (28-11-2014) dated 7-11-2017 registration letter.
Pharmacopoeia (Duplicate)
Specs 16‘s: Rs. 280/-
53. Munawar Artelum 40/240 Form 5 WHO approved ● Both fee chalan Approved.
Pharma Tablets 11-11-2010 formulation needs verification Reference will be
(Pvt) Ltd., Each tablet (DUPLICATE from budget and sent to Budget &
31 Km, contains:- DOSSIER) Artem -DS Plus account division. Accounts Division
Ferozepur Artemether…40mg PKR 8,000/- Tablets by Hilton for verification of
Road, Lumefantrine……24 (11-11-2010) challan and Board
Lahore 0mg (Duplicate) GMP certificate authorized its
(Anti-malarial) + issued based on Chairman for the
PKR 12,000/- the inspection issuance of
International (28-11-2014) dated 7-11-2017 registration letter.
Pharmacopoeia (Duplicate)
Specs 8‘s: Rs. 260/-
54. Munawar Muna Pol-C Form 5 Could not be ● Evide Deferred for
Pharma Suspension 11-11-2010 confirmed nce of approval in evidence of
(Pvt) Ltd., Each 5ml contains: (DUPLICATE reference approval of
31 Km, Paracetamol…120m DOSSIER) Fevernil-C regulatory applied
Ferozepur g PKR 8,000/- Suspension by authorities could formulation in
Road, Chlorphenriamine (11-11-2010) Meditech not be confirmed. reference
Lahore Maleate……..1mg (Duplicate) ● Both fee chalan regulatory
+ GMP certificate needs verification authorities/agencie
(Non-Narcotic PKR 12,000/- issued based on from budget and s which were
Analgesics/ Anti (28-11-2014) the inspection account division. declared/approved
histamine (Duplicate) dated 7-11-2017 by the
60ml: 30‘s Registration
Board in its 275th
meeting.
55. Munawar Monovent Syrup Form 5 Bricanyl 0.3 ● Both fee chalan Approved.
Pharma Each ml contains:- 11-11-2010 mg/ml Syrup by needs verification Reference will be
(Pvt) Ltd., Terbutaline (DUPLICATE AstraZeneca UK from budget and sent to Budget &
31 Km, Sulphate………0.3 DOSSIER) (MHRA account division. Accounts Division
Ferozepur mg PKR 8,000/- Approved) for verification of
Road, (Bronchodilators (11-11-2010) challan and Board
Lahore and anti-asthma) (Duplicate) Britanyl syrup by authorized its
+ Barrett Hodgson Chairman for the
PKR 12,000/- issuance of
(28-11-2014) GMP certificate registration letter.
(Duplicate) issued based on
60ml: 28‘s the inspection
dated 7-11-2017
56. Munawar Monovent Tablets Form 5 Terbutaline tablet● Both fee chalan Approved.
Pharma 2.5mg 11-11-2010 by Lannett needs verification Reference will be
(Pvt) Ltd., Each tablet (DUPLICATE (USFDA from budget and sent to Budget &
31 Km, contains:- DOSSIER) Approved) account division. Accounts Division
Ferozepur Terbutaline PKR 8,000/- for verification of
Road, Sulphate……….2.5 (11-11-2010) Britanyl 2.5mg challan and Board
Lahore mg (Duplicate) tablet by Barrett authorized its
(Bronchodilators + Hodgson Chairman for the
and anti-asthma) PKR 12,000/- issuance of
(28-11-2014) GMP certificate registration letter.
USP Specs (Duplicate) issued based on
10x10‘s: the inspection
Rs. 128/- dated 7-11-2017
57. Munawar Pioglirde 15/2 Form 5 Could not be ● Evide Deferred for
Pharma Tablets 11-11-2010 confirmed nce of approval in evidence of
(Pvt) Ltd., Each tablet (DUPLICATE reference approval of
31 Km, contains:- DOSSIER) Piozer G Tablet regulatory applied
Ferozepur Pioglitazone as PKR 8,000/- by Hilton Pharma authorities could formulation in
Road, hydrochloride….15 (11-11-2010) not be confirmed. reference
Lahore mg (Duplicate) GMP certificate ● Both fee chalan regulatory
Glimepride…..2mg + issued based on needs verification authorities/agencie
(Oral PKR 12,000/- the inspection from budget and s which were
Hypoglycaemics) (28-11-2014) dated 7-11-2017 account division. declared/approved
(DUPLICATE by the
USP Specs ) Registration
10‘s: Rs. 100/- Board in its 275th
20‘s: Rs. 200/- meeting.
58. Munawar Pizot Tablets Form 5 Pizotifen 0.5mg ● Refer Registration
Pharma Each sugar coated 30-11-2010 tablet by ence product is Board rejected the
(Pvt) Ltd., tablet contains:- (DUPLICATE Tillomed Lab available as film case as firm has
31 Km, Pizotifen as DOSSIER) (MHRA coated tablet, applied for
Ferozepur hydrogen PKR 8,000/- Approved) while firm has indications other
Road, maleate….0.50mg (30-11-2010) applied for sugar than that of
Lahore (Appetite Stimulant) (DUPLICATE Mosegor tablet coated tablet. reference product.
) by Sandoz ● Firm
BP Specs + has applied for
PKR 12,000/-
GMP certificate appetite stimulant
(28-11-2014)
issued based on as
(DUPLICATE the inspection pharmacological
) dated 7-11-2017 group and clinical
30‘s: Rs. 80/- indication
● Both fee chalan
needs verification
from budget and
account division.
59. Semos Glamin XR 8mg Form 5 Razadyne ER ● Evidence of Deferred for
Pharmaceuti Capsule Dy.No.810 Capsule by me-too could evidence of
cals (Pvt) Each capsule (2-5-2012) Janssen not be applied
Ltd., Plot contains: PKR 8,000/- (USFDA confirmed formulation/drug
No. 11, Galantamine (as (2-5-2012) Approved) ● The already approved
Sector 12- hydrobromide)….8 (DUPLICAT formulation by DRAP (generic
A, North mg E) Could not be submitted by / me-too status)
Karachi (Anticholinesterases) + confirmed the firm along with
Industrial Rs.12,000/- contains registration
Area, USP Specs (17-6-2015) Last inspection powder, while number, brand
Karachi. (DUPLICAT conducted on 17- the reference name and name of
E) 10-2017―with product firm, or else
1x10‘s, good GMP contains application on
2x10‘s, compliance extended form-5D alongwith
3x10‘s: As per release differential fee and
SRO granules filled stability study
in capsule. data as per the
requirement of
Registration
Board in its 278th
meeting.
Case No.3 Deferred cases of previous meetings
Evaluator PEC-II
60. Name and address of manufacturer / M/s Mediate Pharmaceutical (Pvt) Limited, Plot No.150-151,
Applicant Sector 24, Korangi Industrial Area, Karachi
Brand Name +Dosage Form + Strength SPAS-FORT TABLETS 80mg/80mg
Composition Each sugar-coated tablet contains:
Phloroglucinol hydrate…………………….80mg
Trimethylphloroglucinol…………………..80mg
Pharmacological Group Gastrointestinal Anticholinergics/Antispasmodics
Type of Form Form-5
Finished product Specification As per Innovator Specification
Pack size & Demanded Price 1 x 30‘s ; RS.450/- per tablet
Approval status of product in Reference Spasfon Tablet (ANSM Approved)
Me-too status Spasrid Tablet of M/s Barrett Hodgson Pakistan (Pvt) Ltd
GMP status Last Inspection conducted on 15-12-2017and report
concludes that firm is operating at an acceptable level of
GMP compliance.
Previous remarks of the Evaluator. ● Sugar coated and film-coated both are mentioned.
Previous decision(s) Deferred in 279th meeting for clarification of dosage form
since reference product is available as sugar coated tablet
whereas firm has mentioned both film coated & sugar coated
in composition.
Evaluation by PEC ● Firm has clarified that applied formulation is a sugar coated
tablet and has submitted master formulation accordingly.
Brand Name +Dosage Form + Strength Taglip-M 50mg/500mg
Sitagliptin as phosphate Monohydrate……..50mg
Metformin HCl……………………………500mg
Type of Form Form-5
Finished product Specification As per Innovator Specification
Pack size & Demanded Price 1 x 14‘s ; as per SRO
Me-too status Treviamet tablet of M/s Getz Pharmaceuticals Pvt. Ltd
GMP status Last Inspection conducted on 15-12-2017and the report
includes that firm is operating at an acceptable level of GMP
compliance.
Previous decision(s) Deferred in 279th meeting for clarification of
pharmacological group.
Evaluation by PEC ● Firm has clarified the pharmacological group for applied
formulation as Anti-diabetic
Brand Name +Dosage Form + Strength M-Oril Capsule 120mg
Composition Each hard capsule contains:
Orlistat (pellets 50% w/w)………………. 120mg
Type of Form Form-5
Pack size & Demanded Price 1 x 10‘S ; as per SRO
Approval status of product in Reference Approved in USFDA
Me-too status Orlis 120mg capsule of M/s Ferozsons
GMP status Last Inspection conducted on 15-12-2017 and report
concludes that firm is operating at an acceptable level of
GMP compliance.
Previous remarks of the Evaluator. ● Source of pellets is M/s Biocon limited, Bangalore,
India.
● CoA of manufacturer is submitted.
● GMP certificate of manufacturer is not provided.
Previous decision(s) Deferred in 279th meeting for submission of fee of Rs.
80,000/- for import of pellets & GMP certificate of supplier.
Evaluation by PEC ● Firm has changed source of pellets to M/s Vision
Pharmaceuticals, Islamabad and has submitted required
documents.
Decision: Approved
Evaluator PEC-XIV
63. Name and address of manufacturer / M/s Pearl Pharmaceuticals, Islamabad
Applicant
Brand Name +Dosage Form + Strength Profen 300mg Tablet
Dexibuprofen…….300mg
Diary No. Date of R& I & fee Dy. No.8022; 29-1-2011; Rs.12,000/- (3-7-2015); Rs.8,000/-
(29-01-2011)
Type of Form Form-5
Pack size & Demanded Price 3x10‘s: As per SRO
Approval status of product in Reference MHRA
Me-too status Dexib 300mg tablet of Tabros (Reg # 067493)
GMP status Last inspection report 2-8-2016 the panel recommends the
grant of renewal of DML.
Previous remarks of the Evaluator. Inspection report does not fall within 1 year
Application was received through letter No.F.6-2/2016 Reg-III
Previous decision(s) ● Deferred in 274th meeting for submission of last GMP
inspection report conducted within a year
Evaluation by PEC ● Inspection conducted on 08-02-2018, overall GMP
compliance of the firm was found satisfactory.
● The firm has applied uncoated tablet while in reference
country the formulation is film coated tablet.
Decision: Deferred for confirmation of film coating in applied formulation.
Applicant
Brand Name +Dosage Form + Strength Pazidime 1gm IM/IVInjection
Ceftazidime (as Pentahydrate)……..1gm
(2-03-2011)
Type of Form Form-5
Approval status of product in Reference Ceftazidime by Sandoz
Me-too status Cefcom by Barrett Hodgson Pharmaceuticals
Evaluation by PEC ● Inspection conducted on -08-02-2018, overall GMP
● The firm has provided Dry powder for injection
(Cephalosporin section).
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Peflex 100mg Dry powder drops
Cephalexin as Monohydrate….100mg
(29-01-2011)
Type of Form Form-5
Finished product Specification Mfg
Pack size & Demanded Price 30ml bottle: Rs.110/15ml bottle
Approval status of product in Reference Cephalexin Suspension 100mg/ml by Facta Farma USFDA
Me-too status Ceflin drops by Ferozsons
Evaluation by PEC ● Inspection conducted on -08-02-2018, overall GMP
● The firm has provided Cephalosporin suspension section.
Evaluator PEC-III
Sr. Name and Brand Name Type of Remarks on Decision of previous Evaluation by PEC
#. address of (Proprietary Form the meeting of Registration
manufact name + Initialformulation Board
urer / Dosage Form date, (if any)
Applicant + Strength) diary including
Composition Fee Internationa
Pharmacolog including l status in
ical Group differentia stringent
Finished l fee drug
product regulatory
Specification Demanded agencies /
Price / authorities
Pack size Me-too

status
GMP status as
depicted in
latest
inspection
report (with
date) by the
Evaluator
66. M/s Rasco METZONE Form 5 Pioglitazone/ Deferred for updated Firm has submitted
Pharma, 5.5 Tablets 29-06-2012 metformin status of GMP of the GMP certificate issued
Km Each film (DUPLICA tablet by firm form QA & LT by DDG, Lahore on the
Raiwind coated tablet TE Torrent division as inspection basis of inspection
Road contains: DOSSIER) Pharma report submitted by conducted on 22-02-
Lahore Pioglitazone PKR 8,000/- (MHRA firm does not 2018
(as (29-06- Approved) conclude GMP
hydrochloride) 2012) compliant status.
….15mg (Duplicate) Piozer plus (M-279)
Metformin + tablets
hydrochloride PKR byHilton
….500mg 12,000/-
(Antidiabetic)
(30-7-2013) Last
USP Specs (Duplicate) inspection
1x10‘s: As report dated
per SRO 17th Feb and
24th March
2017 confirms
fair level of
compliance to
GMP
67. Rasco METZONE Form 5 Pioglitazone/ Deferred for updated Firm has submitted
Pharma, EXTRA Dy No. 5869 metformin status of GMP of the GMP certificate issued
5.5 Km Tablets 29-06-2012 tablet by firm form QA & LT by DDG, Lahore on the
Raiwind Each film PKR.8000/- Torrent division as inspection basis of inspection
Road coated tablet (29-06- Pharma report submitted by conducted on 22-02-
Lahore contains:- 2012) (MHRA firm does not 2018
Pioglitazone + Approved) conclude GMP
(as PKR.12000/ compliant status.
hydrochloride) - Piozer plus (M-279)
….15mg (30-7-2013) tablets
Metformin 1x10‘s: As byHilton
hydrochloride per SRO
….850mg Last
(antidiabetic) inspection
USP Specs report dated
17th Feb and
24th March
2017 confirms
fair level of
compliance to
GMP
Decision: Approved.
68. Rasco SITAGLIP Form 5 Janumet by Deferred for updated Firm has submitted
Pharma, Tablet 29-06-2012 MSD status of GMP of the GMP certificate issued
5.5 Km Each film PKR.8000/- (MHRA firm form QA & LT by DDG, Lahore on the
Raiwind coated tablet (29-06- Approved) division as inspection basis of inspection
Road contains:- 2012) Treviamet report submitted by conducted on 22-02-
Lahore Sitagliptin (as (Duplicate) tablet by Getz firm does not 2018
phosphate)..50 + Last conclude GMP
mg PKR inspection compliant status.
Metformin 12000/- report dated (M-279)
hydrochloride (30-7-2013) 17th Feb and
…500mg 1x10‘s: 24th March
(Antidiabetic) As per SRO 2017 confirms
fair level of
compliance to
GMP
69. Name and address of manufacturer / M/s. Rasco Pharma, 5.5 Km Raiwind Road, Lahore
Applicant
Brand Name +Dosage Form + Strength Quantum Tablet 25mg
Quetiapine Fumarate eq. to Quetiapine……….25mg
Diary No. Date of R& I & fee Duplicate, 02-02-2016, 20,000/-,(Photocopy attached)
29-01-2016
Type of Form Form-5
Finished product Specification In-house specifications
Pack size & Demanded Price 1×10‘s ; As per SRO
Approval status of product in Reference Seroquel of Astrazeneca, USFDA
Me-too status Qusel Tablet of Hilton Pharma (Reg # 037684)
GMP status Inspection for grant of GMP certificate conducted on
17-02-2017 & 24-03-2017, the firm was considered to
be operating at Fair level of GMP compliance.
Decision of 279th meeting of Registration Deferred for updated status of GMP of the firm form
Board QA & LT division as inspection report submitted by
firm does not conclude GMP compliant status.
Evaluation by PEC Firm has submitted GMP certificate issued by DDG,
Lahore on the basis of inspection conducted on 22-2-
2018
70. Name and address of manufacturer / M/s. Rasco Pharma. 5.5 Km Raiwind Road, Lahore
Applicant
Brand Name +Dosage Form + Strength Quantum Tablet 200mg
Diary No. Date of R& I & fee Duplicate, 02-02-2016, 20,000/-, (Photocopy attached)
29-01-2016
Type of Form Form-5
Approval status of product in Reference Seroquel 200 of Astrazeneca USFDA
Me-too status Qusel-200 Tablet of Hilton Pharma (Reg # 037690)
2018
Decision: Approved with innovator’s specification and change of brand name. Reference will be
sent to Budget & Accounts Division for verification of challan and Board authorized its Chairman
for the issuance of registration letter.
71. Name and address of manufacturer / M/s. Rasco Pharma. 5.5 Km Raiwind Road, Lahore
Applicant
Brand Name +Dosage Form + Strength Quantum Tablet XR-300mg
Composition Each extended release film coated tablet contains:
Diary No. Date of R& I & fee Duplicate, 02-02-2016, 20,000/-,(Photocopy attached)
29-01-2016
Type of Form Form-5
Approval status of product in Reference Seroquel XR-300 of Astrazeneca USFDA
Me-too status Qusel XR 300mg Tablet of Hilton Pharma (Reg#
076087)
2018
sent to Budget & Accounts Division for verification of challan and Board authorized its Chairman
for the issuance of registration letter.
Case No. 4 Registration applications of drugs for which stability study data is required
to be verified.
VERIFICATOIN OF GENUINENESS / AUTHENTICITY OF STABILITY DATA AND ASSOCIATED
DOCUMENTS
Sr. Name & Address of Brand Name Type of Form, International Previous DRB
No. Manufacturer / Applicant (Proprietary Name + Initial Diary & Availability / Decision /
Dosage Form + Date, Fee Local Remarks
Pharmacological Demanded Price GMP
Group, / Pack size Inspection
72. M/s Hilton Pharma (Pvt.) RASIDON 20mg Form-5-D LATUDA by Decision 254th
Ltd. 13, Sector 15, Korangi Sunovion RB meeting:
Industrial Area, Each Tablet contains: Dy. No: 183 Pharms INC,
Lurasidone dated 13-02- USFDA. The Board
Karachi. HCl…20mg 2013 considered the
Not applicable application and
(Antipsychotic) 50,000/- dated deferred for
13-02-2013 GMP compliant submission of
dated 19-07- scientifically
10‘s, 20‘s, 30‘s 2017. rational lab
Rs.13,000/- scale data as per
Rs.26,000/- guidelines
Rs.39,000/- approved in
251st meeting
Drug RASIDON 20mg (Lurasidone HCl)
Name of Manufacturer M/s Hilton Pharma (Pvt.) Ltd. Karachi.
Manufacturer of API M/s Hetero Drugs Limited Unit-IX, India.
API Lot No. LS0040416
Description of Pack Alu-Alu Foil.
Stability Storage Condition Accelerated: 40°C ± 2°C &75±5%RH
Real Time: 30°C ± 2°C &65±5%RH
Frequency Accelerated: 0,3,6 (Month)
Batch No. RAS-232301-1 RAS-232401-2 RAS-232501-3
Manufacturing Date Jan – 2017 Jan – 2017 Jan – 2017
No. of Batches 03
No.
1. COA of API Yes
2. Approval of API by regulatory authority of country Photocopy of GMP Certificate No.
of origin or GMP certificate of API manufacturer L.Dis.No.3682/P&B/2017 issued by Director Drugs
issued by regulatory authority of country of origin. Control Administration (Andhra Pradesh) India is
submitted.
The Certificate is valid for a period of Two years from
the date of issue (27-10-2017) and is meant for Export
of Drugs only.
respective documents like chromatograms, laboratory
5. Documents confirming import of API etc. Photocopy of ADC (Karachi) attested Commercial
Invoice for Batch No. LS0040416 (3Kg) is submitted.
Dated 21-06-2016.
6. All provided documents will be attested (name, sign Yes
and stamp) for ensuring authenticity of data /
documents.
1978.
● The firm has submitted 06 Months Accelerated and 06 Months Real Time Stability Study Data for 03 Trial
Batches.
● The Master formulation submitted with stability study data depicts dosage form as film coated tablet.
No. Manufacturer / Applicant(Proprietary Name + Initial Diary & Availability / Decision /
Ltd. Sunovion RB meeting:
Each Tablet contains: Dy. No: 180 Pharms INC,
13, Sector 15, Korangi Lurasidone dated 13-02-2013 USFDA. Stability Studies
Industrial Area, HCl…40mg conducted under
50,000/- dated Not applicable the Zone IV-A
Karachi. (Antipsychotic) 13-02-2013 conditions as
GMP compliant per ICH / WHO
10‘s, 20‘s 30‘s dated 19-07- guidelines.
Rs.14,000/- 2017.
Rs.28,000/-
Rs.42,000/-
Alu-Alu Foil. Alu-Alu Foil.
Manufacturing Date Mar – 2017 Mar – 2017 Mar – 2017
No. of Batches 03
No.
1. COA of API Yes
submitted.
of Drugs only.
Dated 21-06-2016.
documents.
1978.
Batches.
74. M/s Hilton Pharma (Pvt.) RASIDON 60mg Form-5-D LATUDA by The firm has
Ltd. 13, Sector 15, Korangi Sunovion claimed
Industrial Area, Each film coated tablet Dy. No: 998 Pharms INC, Lurasidone HCl
contains: dated 16-06-2014 USFDA. 60mg in
Karachi. Lurasidone Rs. 50,000/- application form
HCl…60mg dated 16-06-2014 Not applicable whereas in
composition it is
(Antipsychotic) Rs. 750/- per GMP compliant mentioned that
tablet for 10‘s dated 19-07- equivalent
and 30‘s. 2017. amount of
Lurasidone HCl
is 64.4446mg.
The firm has

claimed In-
house
Specifications.
Manufacturing Date Mar – 2017 Mar – 2017 Mar – 2017
No. of Batches 03
No.
1. COA of API Yes
submitted.
of Drugs only.
Dated 21-06-2016.
documents.
1978.
Batches.
● The firm has claimed Lurasidone HCl 60mg in application form whereas in composition it is mentioned that
equivalent amount of Lurasidone HCl is 64.4446mg. Moreover the master formulation submitted with stability
study data depicts Label claim as Lurasidone HCl 60mg.
Ltd. Sunovion RB Meeting:
Each Tablet contains: Dy. No: 141 Pharms INC, The Board
13, Sector 15, Korangi Lurasidone dated 13-02- USFDA. considered the
Industrial Area, HCl…80mg 2013 application and
Not applicable deferred for
Karachi. (Antipsychotic) 50,000/- dated submission of
13-02-2013 GMP compliant scientifically
dated 19-07- rational lab
10‘s, 20‘s 30‘s 2017. scale data as per
Rs.15,000/- guidelines
Rs.30,000/- approved in
Rs.45,000/- 251st meeting.
Manufacturing Date Apr – 2017 Apr – 2017 Apr – 2017
No. of Batches 03
No.
1. COA of API Yes
submitted.
of Drugs only.
Dated 21-06-2016.
documents.
1978.
Batches.
Report on Investigation of Authenticity / Genuineness of data submitted for registration of RASIDON 20mg,
40mg, 60mg and 80mg (Lurasidone HCl) Tablets by M/s. Hilton Pharma (Pvt.) Ltd., Plot No. 13-14, Sector 15,
Korangi Industrial Area, Karachi.
Reference No: F.13-11/2017-PEC dated 21st March, 2018.
Investigation Date and Time: 27th March, 2018. (Forenoon)
Investigation Site: Factory premises of M/S. Hilton Pharma (Pvt.) Ltd., Plot No. 13-14, Sector 15, Korangi
Background:
Chairman Registration Board considered the applications of M/s. Hilton Pharma (Pvt.) Ltd., Plot No. 13-14,
Sector 15, Korangi Industrial Area, Karachi for registration of RASIDON 20mg, 40mg, 60mg and 80mg (Lurasidone
HCl) Tablets and constituted a three member panel to investigate the authenticity / genuineness of data (import of
raw material and stability data). Panel was advised to conduct inspection of the firm and to submit report for further
consideration.
1. Prof. Dr. Rafeeq Alam Khan, Meritorious Professor and Chairman, Department of Pharmacology, University
of Karachi, Karachi. (Member Registration Board).
3. Dr. Affan Ali Qureshi, Assistant Director, DRAP, Karachi.
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 were also audited.
The details of investigation may be summarized as under:
Sr. No. Question Observation by Panel

Q.No.1 Do you have documents confirming Firm has imported 3kg Lurasidone HCl from M/s
the import of API including approval Heterodrugs Ltd India. They have proper approval from
from DRAP? DRAP, Karachi for the import of API with details as below:
Batch No. Date Of Invoice No. Quantity

Import Imported.
LS0040416 21-06-16 1000020444 3.0 kg
Q.No.2 Do you have any rationale behind The rationale behind selecting the API manufacturers is
selecting the particular manufacturer GMP approval by competent authorities and desk top audit.
of API?
Q.No.3 Do you have documents confirming Firm has documents confirming the import of working
the import of reference standard and standard of the API and three impurity standards from M/s
impurity standards? Hetero Drugs Ltd India.
Q.No.4 Do you have certificate of Analysis of The firm has certificates of analysis of API, working
the API, reference standards and standard of API and three major impurity standards.
impurity standards?
Q.No.5 Do you have any approval of API or The firm has provided copy of GMP certificate issued by
GMP certificate of API manufacturer Drugs Control Administration, Andhra Pradesh India dated
issued by regulatory authority of 27-10-2016 Valid Up to 19-10-2020.
country of origin?
Q.No.6 Do you use API manufacturer method The firm has API manufacturer‘s method of testing for
of testing? Lurasidone HCl.
Q.No.7 Do you have stability studies reports The firm has stability studies reports on Lurasidone HCl
on API? conducted by the API manufacturer.
Q.No.8 If Yes, whether the stability testing The stability testing has been performed as per SIM method
has been performed as per SIM and degradation products have been quantified.
method and degradation products
have been quantified?
Q.No.9 Do you have method for quantifying The manufacturer has gradient HPLC method for quantifying
the impurities in the API? the impurities in the API.
Q.No.10 Do you have some remaining The firm has remaining quantities of API, its working
quantities of the API, its reference standard and three major impurity standards.
Q.No.11 Have you used pharmaceutical grade The firm has used pharmaceutical grade excipients. The
excipients? excipients include:
Mannitol, Pregelatinized Starch, Hydroxypropyl methyl
cellulose, Crosscarmellose sodium and Magnesium Stearate
Q.No.12 Do you have documents confirming The firm has necessary documents confirming the import of
the import of the used excipients? the used excipients.
Q.No.13 Do you have test reports and other The firm has test reports and other records on the excipients
Q.No.14 Do you have written and authorized The firm has written and authorized protocols for the
protocols for the development of development of Rasidon 80mg/60 mg/40 mg/20 mg Tablets.
Rasidon 80mg/60 mg/40 mg/20 mg
Tablets?
Q.No.15 Have you performed Drug-excipient The firm has used same excipients as used in innovator
compatibility study? product (Latuda), therefore compatibility studies have not
been preformed.
Q.No.16 Have you performed comparative 1. The firm has performed comparative dissolution study
dissolution studies? for Rasidon 80mg Tablets only against Innovator product
(Latuda 80 mg Tablets manufactured by Sunovion
Pharmaceuticals Inc. USA). The Rasidon 80mg Tablets
has comparable dissolution profile with that of the
originator product.
2. It is submitted that Rasidon HCl is very weekly
soluble in water. The studies conducted at pH 1.2 and
6.8 has dissolution rate as under:
pH 1.2: around 25% in 60 minutes
pH 6.8: 0% in 60 minutes
using 0.5% SLS the dissolution has been enhanced
with f2 factor of 53 only.
3. The firm has not conducted any comparative
dissolution profile for Rasidon 60mg, 40mg and 20mg
Tablets beside the fact that API is very weekly soluble
in water and classified as Class IV API as per BCS
classification.
Q.No.17 Do you have product development The firm has dedicated product development (R&D) section
(R&D) section? with requisite analysis and manufacturing facilities, however
blistering was done in production area.
Q.No.18 Do you have necessary equipment The firm has all the necessary equipment available in product
available in product development development section for development of Rasidon
section for development of Rasidon 80mg/60mg/40mg /20mg Tablet except blistering machine.
80mg/60mg/40mg /20mg Tablet?
Q.No.19 Are the equipment in the product The available equipments in product development section are
development section qualified? qualified.
Q.No.20 Do you have proper maintenance and The firm has proper maintenance and calibration/re-
calibration/re-qualification program qualification program for the equipment used in product
for the equipment used in the PD development.
Section?
Q.No.21 Do You have qualified staff in the The firm has a team of 17 qualified person in product
product development section with development section with proper knowledge and training in
proper knowledge and training in the the product development.
product development?
Q.No.22 Have you manufactured three stability The firm has manufactured three stability batches for the
batches for the stability studies of stability studies Rasidon 80mg /60mg/40mg/20mg Tablets
Rasidon 80mg/60mg/40mg /20mg with details as below:
Tablet as required?
Rasidon Tablet 80 mg
Batch No. Batch Size
RAS-240304-7 1600 Tablet
RAS-240404-8 1600 Tablet
RAS-240504-9 1600 Tablet
RAS-237903-4 2133 Tablet
RAS-238003-5 2133 Tablet
RAS-238103-6 2133 Tablet
RAS-238203-4 3200 Tablet
RAS-238303-5 3200 Tablet
RAS-238403-6 3200 Tablet
RAS-232301-1 5600 Tablet
RAS-232401-2 5600 Tablet
RAS-232501-3 5600 Tablet
The tablets are packed in Alu Alu Blister with pack size of
3x 10‘s.
Q.No.23 Do you have any criteria for fixing The criteria for fixing the batch size of the stability batches is
the batch size of stability batches? the quantity required for testing frequency and number of
testing frequencies.
Q.No.24 Do you have complete record of The firm has complete record of production of stability
production batches? batches. All the log books are properly maintained.
Q.No.25 Do you have protocols for stability The firm has detailed protocols for stability testing of
testing of stability batches? stability batches.
Q.No.26 Do you have developed and validated The firm has developed and validated method for testing of
the method for testing of stability stability batches.
batches?
Q.No.27 Do you have method transfer studies Not applicable
in case when the method of testing
being used by your firm is given by
any other lab?
Q.No.28 Do you have documents confirming The firm has proper documents confirming the qualification
the qualification of equipment / of equipment /instruments being used in the test and analysis
instruments being used in the test and of Lurasidone HCl API and finished product.
analysis of Lurasidone HCl and the
finished drug?
Q.No.29 Do your method of analysis stability The firm has performed force degradation studies on their
Indicating? product for conformance of stability indicating nature of
method of testing.
Q.No.30 Do your HPLC Software 21CFR The HPLC software is 21 CFR compliant.
compliant?
Q.No.31 Can you show Audit Trail reports on Audit trail on the testing reports of Rasidon
Rasidon 80mg/60mg/40mg /20mg 80mg/60mg/40mg /20mg Tablet is available.
Tablet testing?
Q.No.32 Do you have some remaining The firm has some remaining quantities of stability batches.
quantities of degradation products
and stability batches?
Q.No.33 Do you have stability batches kept on The firm has kept three stability batches of each potency on
real time stability testing? real time stability testing.
Q.No.34 Do you have valid calibration The firm has valid calibration status for the equipment used
status for the equipment used in in Rasidon 80mg/60mg/40mg /20mg Tablet Tablet
Rasidon 80mg/60mg/40mg /20mg production and analysis.
Tablet production and analysis?
Q.No.35 Do proper and continuous monitoring Adequate monitoring and control are available for stability
and control are available for stability chamber. Chamber are controlled and monitored through
chamber? software having alarm system for alerts as well.
Q.No.36 Do related manufacturing area, Related manufacturing area equipment, personnel and
equipment, personnel and utilities be utilities are GMP compliant.
rated as GMP compliant?
CONCLUSION & RECOMMENDATIONS:

1. On the basis of risk based approach the genuineness / authenticity of stability data submitted by the firm for
registration of RASIDON (Lurasidone HCl) 80mg only is verifiable to satisfactory level.
2. Firm has not conducted Comparative dissolution profile studies on RASIDON 20mg, 40mg and 60mg
Tablets which could not be ignored especially in BCS class IV products.
3. Related manufacturing area, equipment, personnel and utilities are rated as GMP compliant. Hence,
Registration of RASIDON (Lurasidone HCl) 80mg Tablets may be recommended in the name of the
manufacturer.
4. Furthermore, the firm will conduct Comparative dissolution profile studies for RASIDON 20mg, 40mg and
60mg Tablets before registering these potencies in their name as the data regarding the other points has
already been evaluated and found satisfactory.
5. Since, Lurasidone HCl falls in BCS Class IV, therefore the panel strongly recommends post registration
bioequivalence studies for RASIDON Tablets & other similar brands containing Lurasidone HCl being
registered in the country.
Note: The firm has submitted written commitment for bioequivalence studies on the product by October 2018.
Decision: Registration Board decided to approve registration of “RASIDON 20mg, 40mg, 60mg and 80mg
(Lurasidone HCl)Tablets by M/s. Hilton Pharma (Pvt.) Ltd., Plot No. 13-14, Sector 15, Korangi Industrial
Area, Karachi. Manufacturer will place first three production batches on long term stability studies
throughout proposed shelf life and on accelerated studies for six months.
No. Manufacturer / (Proprietary Name + Initial Diary & Date, Availability / (IF ANY)
Applicant Dosage Form + Fee (including Local
Group, Inspection
76. M/s Genix Pharma Pvt. Wymly Tablets Form 5-D Approved by The firm has
Ltd. Karachi. 25 mg Diary No. 4854 dated USFDA claimed
Each film coated tablet
06-06-2017. Not applicable. Manufacturer
contains: Rs.50,000/- dated 05- Last GMP ‘s
Tenofovir 06-2017 inspection Specifications
Alafenamide fumarateRs. 32,00/- per tablet conducted on
eq. to 10‘s = Rs. 32,000/-
Tenofovir 08-08-2017
Alafenamide ……20‘s = Rs. 64,000/- ,and the
25mg 30‘s = Rs. 96,000/- report
concludes that
(Anti-hepatitis) firm is
operating at
satisfactory
level of
compliance of
GMP.
Drug Wymly Tablets 25 mg
Name of Manufacturer M/s Genix Pharma Pvt. Ltd. Karachi
Manufacturer of API M/s Shenghai Desano Chemical Pharmaceutical Co., Ltd.
API Lot No. DBH251-4-B15A-160401A
Description of Pack Alu-alu blister foil packed in unit carton
Time Period Real Time: 6 months
Frequency Real Time: 0,1,2,3,4,6 (months)
Batch No. TR-001 TR-002 TR-003
Manufacturing Date 08-2017 08-2017 28-02-2017
No. of Batches 03
No.
1. COA of API Yes
country of origin or GMP certificate of API Copy of GMP Certificate (Certificate No. SH20130005)
manufacturer issued by regulatory authority of issued by SFDA valid upto 25-02-2018
country of origin.
Yes
respective documents like chromatograms, Yes
5. Documents confirming import of API etc. Copy of Form 6 (license to import Drug for clinical trial ,
examination, test for analysis) issued by ADC, DRAP,
Karachi date 16-06-2016 has been submitted
6. All provided documents will be attested (name,
sign and stamp) for ensuring authenticity of data Yes
/ documents.
7. Commitment to continue real time stability study
Yes
8. Commitment to follow Drug Specification Rules,
Yes
1978.
● The firm has provided 26 weeks Accelerated and 06 Months Real Time Stability Data for 03 Lab Scale Batches.

Report on Investigation of Authenticity / Genuineness of data submitted for registration of Wymly (Tenofovir
Alafenamide hemifumarate) 25mg Tablets by M/s Genix Pharmaceuticals Pvt. Limited, Karachi.
Reference No: F.13-11/2017-PEC dated 6th April, 2018.

Investigation Date and Time: 9th April, 2018. (Afternoon)
Investigation Site: Factory premises of Genix Pharmaceuticals Pvt. Ltd. Karachi.
Background:
Chairman Registration Board considered the applications of M/s. Genix Pharmaceuticals (Pvt.) Ltd., Karachi
for registration of Wymly (Tenofovir Alafenamide hemifumarate) 25mg Tablets and constituted a three member
panel to investigate the authenticity / genuineness of data (import of raw material and stability data). Panel was
advised to conduct inspection of the firm and to submit report for further consideration.
1. Dr. Rafeeq Alam Khan, Meritorious Professor and Chairman Department of Pharmacology, University of
Karachi, Karachi.
2. Dr. Syed Muzafar Ali Jafri, Director, DTL Sindh, Karachi.
Details of Investigation:
S.No. Description Observation by panel

The firm has imported 150.0g Tenofovir Alafenamide
Do you have documents confirming hemifumarate raw material from M/S Shanghai Desano Pharma,
1 the import of API including approval China
from DRAP? Batch No. Quantity Imported
DHB251-4-B15A-160401A 150.0 g
There is proper vendor evaluation process being implemented
by the firm and the rationale behind vendor selection is
Do you have any rationale behind
2 controlled through:
selecting the particular manufacturer
The firm has imported 2.0gm of working standard from
Do you have documents confirming
Shanghai Desano Pharma, China. No impurity standard was
3 the Import of Reference standard and
obtained, which were quantified on the basis of RRT mentioned
Impurities standards?
in the DMF.
4 The firm has Certificate of Analysis for API and working
Do you have certificate of analysis of
standards.
the API reference standard and
impurities standards?
Do you have any approval of API or The firm has provided copy of GMP certificate having product
GMP certificate of manufacturer list containing Tenofovir Alafenamide hemifumarate Raw
5
issued by regulatory authority of Material certificate
country of origin?
Do you use API manufacturer method The firm has used API Manufacturer‘s method of testing
6
of Testing for testing of API?
Do you have stability Studies Report The firm has stability studies report of API Tenofovir
7 on API? Alafenamide Hemifumarate conducted by API manufacturer.
If Yes, whether the stability testing has The manufacturer of API has performed the stability studies of
been performed as per SIM method API as per SIM Method and the Related Substance have been
8
and degradation products have been quantified by the API manufacturer
quantified?
Do you have method for quantifying The firm has methods for quantifying the impurities in API.
9
the impurities in the API?
Do you have some remaining The firm has no remaining quantity API Tenofovir Alafenamide
10 quantities of the API, Its reference Hemifumarate but having some remaining quantities of working
standard and impurities standard? standard.
The firm has used pharmaceutical grade excipients.
Have you used pharmaceutical grade Lactose Monohydrate, Microcrystalline cellulose,
11 Croscarmellose Sodium and Magnesium Stearate. Opadry has
excipients?
been used for coating.
Do you have documents confirming The firm has documents confirming the import of the used
12 excipients.
the import of the used excipients
Do you have test reports and other The firm has test reports and other records on the excipients.
13
records on the excipients?
Do you have written and authorized The firm has written and authorized protocol for the
14 protocols for the development of development of Wymly 25mg Tablets.
Wymly 25mg tablets?
Have you performed Drug-Excipient Since firm has used same excipients as used by the innovator.
15 compatibility studies? Therefore, compatibility studies were not performed.
Firm has performed comparative studies with innovator

Have you performed comparative
16 Vemlidy 25mg tablets manufactured by Gilead Sciences, Inc,
studies?
Foster City, CA 94404, Canada.
Do you have Product Development / The firm has product development (R&D) Section with the
17 R&D Section? facility of manufacturing only whereas analysis part was
performed in routine Analytical Laboratory.
Do you have necessary equipment‘s The firm has necessary equipment available in product
available in product development development section for development of Wymly Tablets 25mg.
18
section for development of Wymly
25mg tablets?
Are the equipment‘s in product The available equipment in Product Development are qualified.
19
development qualified?
Do you have proper maintenance / There is proper maintenance / calibration program for the
20 calibration / re-qualification program equipment used in PD.
for the equipment used in PD?
Do you have qualified staff in product The firm has 08 Pharmacists and 03 Chemists for Product
development section with proper Development.
21
knowledge and training in product
development?
The firm has manufactured three stability batches of each 1500
tablets.
Have you manufactured three stability Wymly 25mg tablets
batches for the stability studies of
Wymly 25mg tablets as required? Batch No Date of Mfg. Expiry Date
22
Batch No.TR001 AUG-2017 AUG-2019
Do you have any criteria for fixing the The criteria for fixing the batch size of stability batches is the
23 batch size of stability of batches? number of Tablets per testing frequencies.
Do you have complete record of The firm has complete record for the stability batches of Wymly
24
production of stability batches? 25mg tablets.
Do you have protocols for stability The firm has protocols for testing of stability batches.
25
testing of stability batches
Do you have developed and validated The firm has developed and validated method of testing of
26 the method for testing of stability finish product Wymly 25mg Tablets, based on method of testing
batches of API.
Do you have method transfer studies Method transfer studies is not applicable as the firm developed
in case when the method of testing and validated their own method.
27
being used by your firm is by any
other lab.
Do you have documents confirming The firm has proper documents confirming the qualification of
the qualification of equipment / equipment / instruments being used in the test and analysis of
28 instruments being used in the test and the Wymly 25mg tablets.
analysis of the product‘s API and
product Wymly 25mg tablets?
Do your method of analysis Stability The firm‘s Method of analysis is Stability indicating.
29
indicating?
Do your HPLC software 21CFR The HPLC software is 21CFR compliant and having certificates
30
compliant? of Compliance by USFDA
Can you show audit trail reports on The firm has audit trail Reports on testing.
31
Wymly 25mg Tablets testing?
Do you have some remaining The firm has some remaining quantities of stability batches
32 quantities of degradation products and only.
stability batches?
The firm has three stability batches kept on stability for Real
Do you have batches kept on stability
33 time stability testing. 6 Months Real Time and 6 months
testing?
Accelerated stability studies has been completed.
Do you have valid calibration status The firm has valid calibration status for the equipment used in
34 for the equipment‘s used in Wymly Wymly 25mg tablets production and analysis.
25mg tablets production and analysis?
Do Proper and Continuous monitoring Adequate monitoring and control are available for stability
35 and control are available for stability chamber. Chambers are controlled and monitored through
chamber? software 21CFR compliance.
Do related manufacturing area, Related manufacturing area, equipment, personnel and utilities
36 equipment, personnel and utilities be can be rated as compliant to minimum GMP standards.
Conclusions:
1. On the basis of risk-based approach the genuineness / authenticity of stability data submitted by the firm
for registration of Wymly 25mg Tablets (Tenofovir alafenamide) is verifiable to highly satisfactory level.
2. The related manufacturing area, equipments, personnel and utilities are compliant to minimum standards
of GMP and are suited for the manufacturing of Wymly 25mg Tablets.
Decision: Registration Board decided to approve registration of “Wymly 25mg Tablets (Tenofovir
alafenamide as fumarate)Tablets by M/s Genix Pharmaceuticals Pvt. Limited, Karachi.. Manufacturer will
place first three production batches on long term stability studies throughout proposed shelf life and on
accelerated studies for six months.
77. Kapdex 60mg Capsule (Dexlansoprazole)
78. Kapdex 30mg Capsule (Dexlansoprazole)
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Kapdex

(Dexlansoprazole) 30mg & 60mg DDR Capsule by M/s OBS Pakistan Pvt. Limited, C-14, Manghopir Road,
S.I.T.E, Karachi.
Reference No: F.2-16/2016-PEC (M-277) dated 17th January, 2018.

Investigation Date and Time: 5th April, 2018. (Afternoon)
Investigation Site: Factory premises of M/s OBS Pakistan Pvt. Limited, C-14, Manghopir Road, S.I.T.E,
Karachi.
Background:
Registration Board in 277th meeting considered the applications of M/s OBS Pakistan Pvt. Limited, C-14,
Manghopir Road, S.I.T.E, Karachi for registration of Kapdex (Dexlansoprazole) 30mg and 60mg Capsules.
Registration Board considered scientifically rational laboratory scale data submitted by the firm as pre-requisite of
registration being new formulation and constituted a three member panel to investigate the authenticity / genuineness
of data (import of raw material and stability data). Panel was advised to conduct inspection of the firm as per
decision of Registration Board and to submit report for further consideration.
1. Prof. Dr. Ghulam Sarwar, Dean, Faculty of Phamracy, Jinnah University for Women, 5-C, St-1, Nazimabad,
Karachi.

Details of Investigation:
Q. NO. QUESTION OBSERVATION BY PANEL
1. Do you have documents confirming the Firm has procured 6 kg dexlansoprazole pellets locally
import of API including approval from from M/S. Vision Pharmaceuticals, Islamabad, having
DRAP? Batch number DLP162T vide Invoice No. 300610 dated
09.11.2016
2. What was the rationale behind selecting Selection of the manufacturer has been based upon its
the particular manufacturer of API? GMP Certification and availability of DMF (open part).
Supplier‘s assessment through onsite audit.
3. Do you have documents confirming the The firm has procured working standards of API & two
import of reference standard and impurity major impurities.
standards?
4. Do you have certificate of analysis of API, The firm has certificate of analysis for API, Working
reference standards and impurity standards standards of APIs & Impurities standards.
5. Do you have GMP certificate of API The firm has GMP certificate of API Manufacturer
manufacturer issued by regulatory issued by Drug Regulatory Authority of Pakistan
authority of country of origin? (DRAP)
6. Do you use API manufacturer method of The firm is using API manufacturer method for testing of
the testing for testing API? API.
7. Do you have stability studies report on The firm has accelerated stability studies report of six
API? months and 36 months real time stability reports of API.
8. If yes, whether the stability testing has The stability testing has been performed as per SIM
been performed as per SIM and method and degradation products have been quantified.
degradation products have been
quantified?
9. Do you have methods for quantifying the The firm has method for quantifying the impurities in the
impurities in API? API.
10. Do you have some remaining quantities of The firm has remaining quantities of the API, working
API, the reference standards and standard of API and impurities standard
impurities?
11. Have you used pharmaceutical grade Hard gelatin capsule # 3(30mg) & # 2(60mg) are used.
excepients?
12. Do you have documents confirming the Document regarding import of Hard Gelatin Capsule is
import of used excepients? available.
13. Do you have test reports and other records Test report of Hard Gelatin Capsule is available.
on the excepients used
14. Do you have written and authorized The firm has written and authorized protocols for the
protocols for the development of development of KAPDEX (Dexlansoprazole)
products? CAPSULES 30mg & 60mg
15. Have you performed drug-excepient Not Applicable
16. Have you performed comparative The firm has performed comparative dissolution studies
dissolution studies? in 3 media including pH 0.1N HCl, pH 5.5 & pH 7.0
buffers with DEXILANT Capsule 30mg (Batch:
1451833) & 60mg (Batch: 1408459) manufactured by
M/S. Takeda Pharmaceutical Limited. The firm‘s
products results are comparable to that of the innovator.
17. Do you have product development (R&D) The firm has dedicated area for product development
section? comprising manufacturing & testing facilities for trial
batches.
18. Do you have necessary equipment The firm has necessary equipment for production of trial
available in product development section batches in product development section.
for development of product?
19. Are the equipments in product The equipments used in production and analyses of trial
development section qualified? batches are qualified.
20. Do you have proper maintenance/ The firm has proper maintenance / calibration /
calibration/requalification program for the requalification program for the equipments used in
equipment used in P&D section? production and QC Lab for trial batches.
21. Do you have qualified staff in product The firm has a team of 6 pharmacists for product
development section with proper development section and 2 pharmacist & 3 chemists in
knowledge and training in product analysis of trial batches with operators, with suitable
development? knowledge and training in product development.
22. Have you manufactured stability batches The firm has manufactured three stability batches for the
for the stability studies of the product as stability studies with following details:
required?
Batch # Mfg date Batch size
Kapdex 30mg Capsule
EXP-C-06 Oct-2016 3000 Caps
Kapdex 60mg Capsule
006DS01 Oct-2016 3000 Caps
006DS02 Oct-2016 3000 Caps
The Capsules are packed in blisters Alu/Alu foil with
pack size of 2x 7‘s for both potencies.
23. Do you have criteria for fixing of the As per statement of the firm, the criteria for fixing the
batch size of stability batches? batch size of stability batches is the number of capsules
required per testing and number of testing frequencies.
24. Do you have complete record of The firm has complete record of production of stability
batches. Necessary log book of equipment used have
production of stability batches? been available with the firm, assuring the traceability of
manufacturing and analyses of stability batches.
25. Do you have protocols for stability testing The firm has protocols for stability testing of Stability
of stability products? batches.
26. Do you have developed and validated the The firm has used method for testing of stability batches
method for testing of stability batches? of their finished product, which is stability indicating and
has validated while using the working standards of API,
impurity standards and also supported by forced
27. Do you have method transfer studies in The firm has not conducted method transfer studies.
case when the method of testing used by However, they have validated their method properly.
your firm is given by another firm?
qualification of equipment/instruments qualification of equipment / instruments being used in
being used in the test and analysis of API the test and analysis of API and finished products.
and the finished products?
29. Do your method of analysis stability The firm method of testing is stability indicating for
indicating? stability testing of their finished product, as supported by
forced degradation studies.
30. Do your HPLC software 21 CFR The firm has used 21 CFR compliant HPLC.
compliant?
31. Can you show audit trail reports on Audit trail initially not activated. However, now audit
product testing? trail is activated and reports are available.
32. Do you have some remaining quantities The firm has remaining quantities of stability batches,
degradation products and stability some quantities of working standard of the API and
batches? impurity standards.
33. Do you have stability batches kept on The firm has completed the accelerated stability testing
stability testing? on the three stability batches of KAPDEX
(Dexlansoprazole) CAPSULES 30mg & 60mg. The real
time stability study is in progress on all the three trial
batches of both potencies.
34. Do you have valid calibration status for The firm has valid calibration status for the equipment
the equipment used in production and used in production and analysis of KAPDEX
analysis? (Dexlansoprazole) CAPSULES 30mg & 60mg.
35. Do proper and continuous monitoring and Continuous power supply and monitoring (data loggers)
control are available for stability are available for stability chambers. The data is properly
chamber? reviewed on daily basis.
36. Do related manufacturing area, equipment, The related manufacturing area, equipment, personnel
personnel, and utilities be rated as GMP and utilities are rated as GMP compliant. It is submitted
compliant? that this area has recently been added by the firm as
additional section. The layout and design of HVAC and
other utilities is as per current guidelines. This area has
been provided with necessary buffers, new ducting and
AHU for HVAC and Automatic capsule filling machine.
37. Any specific observation/ The firm has conducted dissolution testing on the pellets
recommendation by the registration at pH 5.5 & 7.0. The results of dissolution testing are
board. well in acceptance to the requirements of the innovator
& the FDA.
The firm must submit their own analysis
record of dissolution testing on pellets
confirming their dual delayed release
profile at pH 5.5 & 6.75/ 7.0.
CONCLUSION:
1. On the basis of risk based approach the genuineness/authenticity of stability data submitted by the firm for
registration of KAPDEX (Dexlansoprazole) 30mg & 60mg capsules is verifiable to satisfactory level.
2. The related manufacturing area, equipments, personals and utilities are GMP compliant and suited for the
manufacturing of KAPDEX (Dexlansoprazole) 30mg & 60mg capsules.
Decision: Registration Board decided to approve registration of “KAPDEX (Dexlansoprazole) 30mg & 60mg
capsules by M/s. OBS Pakistan Pvt. Limited, C-14, Manghopir Road, S.I.T.E, Karachi.. Manufacturer will
place first three production batches on long term stability studies throughout proposed shelf life and on
accelerated studies for six months.
79. VIRATRON Tablets 400mg (Sofosbuvir)
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Viratron

(Sofosbuvir) 400mg Tablet by M/s OBS Pakistan Pvt. Limited, C-14, Manghopir Road, S.I.T.E, Karachi.

Investigation Date and Time: 5th April, 2018. (Forenoon)
Investigation Site: Factory premises of M/s OBS Pakistan Pvt. Limited, C-14, Manghopir Road, S.I.T.E,
Karachi.
Background:
Registration Board in 277th meeting considered the applications of M/s OBS Pakistan Pvt. Limited, C-14,
Manghopir Road, S.I.T.E, Karachi for registration of Viratron (Sofosbuvir) 400mg Tablet. Registration Board
considered scientifically rational laboratory scale data submitted by the firm as pre-requisite of registration being
new formulation and constituted a three member panel to investigate the authenticity / genuineness of data (import of
raw material and stability data). Panel was advised to conduct inspection of the firm as per decision of Registration
Board and to submit report for further consideration.
1. Dr. Rafeeq Alam Khan, Meritorious Professor and Chairman, Department of Pharmacology, University of
Karachi. (Member Registration Board)
2. Dr. Aslam Shah, Sr. Manager Pharmacy, Indus Hospital (Member Registration Board)

Details of Inspection
Q. NO. QUESTION OBSERVATION BY PANEL
1. Do you have documents confirming the Firm has imported Sofosbuvir from M/S. Optimus
import of API including approval from drugs (Pvt.) Ltd. Batch numbers and Quantities are
DRAP? given below:
Lot no. OP-GLD/10/15/037-------2 Kg, vide Invoice
letter No. 476/EXP dated 18.01.2016 and has proper
approval for its import from DRAP Karachi.
Lot no. OP-GLD/12/16/140 -------1 Kg vide Invoice
letter No. 410/EXP dated 30.12.16 and has proper
approval for its import from DRAP Karachi
2. What was the rationale behind selecting the Selection of the manufacturer has been based upon its
particular manufacturer of API? GMP Certification and availability of DMF (open
part), Supplier‘s assessment through Questionnaire.
3. Do you have documents confirming the The firm imported working standards of API & one
import of reference standard and impurity impurity of Sofosbuvir.
standards?
4. Do you have certificate of analysis of API, The firm has certificate of analysis for API, Working
reference standards and impurity standards standards of APIs & Impurities standards.
5. Do you have GMP certificate of API The firm has GMP certificate of API Manufacturer
manufacturer issued by regulatory authority issued by Drugs Control Administration, Government
of country of origin? of Telagana, India.
6. Do you use APIs manufacturer method of the Initially the firm has used in-house testing method.
testing for testing APIs? However, after receiving testing method from API
manufacturer firm is using APIs manufacturer
methods for testing of APIs.
7. Do you have stability studies report on APIs? The firm has accelerated stability studies report of 6
months and 36 months real time stability reports.
8. If yes, whether the stability testing has been The stability testing has been performed as per SIM
performed as per SIM and degradation methods and degradation products have been
products have been quantified? quantified for API.
9. Do you have methods for quantifying the The firm has methods for quantifying the impurities
impurities in API? in the API. However, the quantification has not been
made initially.
10. Do you have some remaining quantities of The firm has remaining quantities of the API,
API, the reference standards and impurities? working standards of API and impurity standard.
11. Have you used pharmaceutical grade The firm has used pharmaceutical grade Excipients
excepients? include:
Microcrystalline Cellulose, Cross Carmelose sodium,
magnesium stearate, mannitol, colloidal silicon
dioxide, sheffcoat PVA, iron oxide yellow, carnuba
wax.
12. Do you have documents confirming the The firm has imported microcrystalline cellulose,
import of used excepients? magnesium stearate, iron yellow oxide, sheffcoat
PVA, carnuba wax vide proper import documents.
And procured colloidal silicon dioxide, mannitol,
locally.
13. Do you have test reports and other records on The firm has test reports and other records on the
the excepients used Excipients used.
14. Do you have written and authorized protocols The firm has written and authorized protocols for the
for the development of products? development of VIRATRON 400mg Tablet
(Sofosbuvir).
15. Have you performed drug-excepient The firm has not performed Drug-Excipients
compatibility studies? compatibility studies as their formulation is similar to
that of the innovator formulation.
16. Have you performed comparative dissolution The firm has performed comparative dissolution
studies? studies in 3 media including pH 1.2, pH 4.5, & pH
6.8 buffers with SOVALDI 400mg Tablet (Batch:
VVDCD) manufactured by M/S. Gilead Sciences,
Inc. USA. The firm‘s product results are comparable
to that of innovator product.
17. Do you have product development (R&D) The firm has dedicated area for the manufacturing of
section? trial batches as well as testing lab.
18. Do you have necessary equipment available The firm has necessary equipment for production of
in product development section for trial batches in product development section.
development of product?
19. Are the equipments in product development The equipments used in production and analysis of
section qualified? trial batches are qualified.
20. Do you have proper The firm has proper maintenance / calibration /
maintenance/calibration/requalification requalification program for the equipments used in
program for the equipment used in P&D production and QC Lab for trial batches.
section?
21. Do you have qualified staff in product The firm has a team of 6 pharmacists for product
development section with proper knowledge development section and 2 pharmacist & 3 chemists
and training in product development? in analysis of trial batches with operators, with
suitable knowledge and training in product
development.
22. Have you manufactured stability batches for The firm has manufactured three stability batches for
the stability studies of the product as the stability studies of VIRATRON 400mg Tablet
required? with batch number & respective batch sizes, EXP-T-
24 (500 Tablets) 019DS01 (2500 Tablets) &
019DS02 (2500 Tablets). The tablets are packed in
Alu/Alu blisters.
23. Do you have criteria for fixing of the batch The criteria for fixing the batch size of stability
size of stability batches? batches is the number of tablets required per testing
and number of testing frequencies.
24. Do you have complete record of production The firm has complete record of production of
of stability batches? stability batches. Necessary log book of equipment
used have been available with the firm, assuring the
traceability of manufacturing and analysis of stability
batches.
25. Do you have protocols for stability testing of The firm has protocols for stability testing of Stability
stability products? batches.
26. Do you have developed and validated the The firm has used stability indicating method for
method for testing of stability batches? testing of stability batches and has validated method,
while using the working standards of APIs and forced
degradation.
27. Do you have method transfer studies in case The firm has not conducted method transfer studies.
when the method of testing used by your firm However, they have validated their method properly.
is given by another firm?
qualification of equipment/instruments being qualification of equipment / instruments being used in
used in the test and analysis of API and the the test and analysis of APIs and finished product.
finished products?
29. Do your method of analysis stability The method of testing is stability indicating for
indicating? stability batches, as supported by forced degradation
studies.
30. Do your HPLC software 21 CFR compliant? The HPLC software is 21 CFR compliant.
31. Can you show audit trail reports on product Audit trail was not activated initially, however, now
testing? audit trail is activated & the current reports on audit
trail are available.
32. Do you have some remaining quantities The firm has remaining quantities of stability batches,
degradation products and stability batches? some quantities of working standards of the API and
impurity standard.
33. Do you have stability batches kept on The firm has completed the accelerated stability
stability testing? testing on the three stability batches of VIRATRON
400mg Tablet. However, the real time stability study
of one batch is completed & 2 batches is in progress.
34. Do you have valid calibration status for the The firm has valid calibration status for the
equipment used in production and analysis? equipment used in production and analysis of
VIRATRON 400mg Tablet.
35. Do proper and continuous monitoring and Continuous power supply and monitoring (data
control are available for stability chamber? loggers) are available for stability chambers. The
data is properly reviewed on daily basis.
36. Do related manufacturing area, equipment, The related manufacturing area, equipment and
personnel, and utilities be rated as GMP utilities cannot be rated as GMP compliant. The
compliant? main observations include the following.
1. The layout design of the area is very old and
not up to the current standards of GMP.
2. The available HVAC system is not properly
designed, functional and validated, hence
posing threats of contamination and cross
contamination
3. Machines are very outdated their qualification
is not possible by design.
4. Other Utilities also need up gradation to
comply GMP regulations.
CONCLUSION:
1. On the basis of risk based approach the genuineness/authenticity of stability data submitted by the firm for
registration of VIRATRON (Sofosbuvir 400mg) tablets is verifiable to satisfactory level.
2. The related manufacturing area, equipments, and utilities cannot be rated as GMP compliant and are not
suited for the manufacturing of VIRATRON (Sofosbuvir 400mg) tablets.
3. The panel recommends that consideration of the VIRATRON 400mg Tablets may be made after successful
improvements by the firm in the following areas:
a. The Layout of the area should be redesigned in the light of current GMP regulations.
b. The HVAC should be redesigned, installed and validated in view of current established guidelines
which fully capable to minimize the risk of contamination and cross contamination.
c. New GMP compliant machines to be provided in granulation, mixing and compression. All the
machines should be properly qualified under well designed qualification program.
d. Other Utilities should also be improved to comply GMP regulations.
Decision: Registration Board decided to defer above case for GMP assessment after renovation of tablet
section. Two members of previous panel will evaluate GMP status of tablet section after information by firm.
80. NUVALDI Tablets 400mg (Sofosbuvir)
Report on investigation of genuineness / authenticity of data submitted for registration of NUVALDI Tablets
400mg (Sofosbuvir) by M/s. Neutro Pharma (Pvt.) Ltd., Lahore.

Investigation Date and Time: 06th April, 2018 (Morning)
Investigation Site: Factory premises of M/s. Neutro Pharma (Pvt.) Ltd., Lahore.
Background:
Registration Board in its 277th meeting held on 27-29th December, 2017 considered the application of M/s.
Neutro Pharma (Pvt.) Ltd., Lahore for registration of NUVALDI Tablets 400mg (Sofosbuvir). Registration Board
considered scientifically rational laboratory scale data submitted by the firm as pre-requisite of registration and
constituted a three member panel for on-site investigation to confirm genuineness / authenticity of stability data and
associated documents, import of API, quality, specification, test analysis, facilities etc. Moreover Registration Board
advised the panel to particularly confirm the claim of Mr. Hamid Raza (CEO of M/s Neutro Pharma) regarding
aqueous film coating of trial batches and dissolution analysis from 21CFR compliant HPLC system. Panel was
advised to conduct inspection of the firm as per decision of Registration Board and to submit report for further
consideration.
1. Mr. Asim Rauf, Additional Director, DRAP, Lahore
2. Mr. Abdul Rashid Sheikh, Area FID, DRAP, Lahore
3. Mr. Muhammad Tahir Waqas, Assistant Director, DRAP Islamabad
Investigation to confirm genuineness / authenticity of stability data and associated documents, import of
API, quality, specification, test analysis, facilities etc.
Q. No. Question Observation by Panel
1. Do you have documents confirming Not applicable.
the import API including approval Firm have used API (Sofosbuvir) purchased from a local
from DRAP? source (M/s Pharmagen Ltd. Lahore). Firm have shown
invoices and documents related to procurement of API
(Sofosbuvir).
2. What was the rationale behind Firm informed that they have selected API‘s supplier on the basis of
selecting the particular manufacturer GMP Certification issued by DDG Lahore (DRAP).
of API? The firm was advised to consider other options for selecting
manufacturer of API as well beside GMP Certification.
3. Do you have documents confirming Firm have used Working Standard / Impurity Standards
the import of API reference standard provided by the API Manufacturer (M/s Pharmagen Ltd.
and impurity standards? Lahore).
M/s Pharmagen Ltd. Lahore in its documents, further
referred to the Working Standard / Impurity Standards
procured from M/s Nantong Chanyo, China and M/s Ruyuan,
HEC China for standardization of their Working Standard /
Impurity Standards.
The firm was advised to procure Reference Standards
from ratified source for standardization of their working
standards.
4. Do you have certificate of Analysis of Firm have certificate of Analysis of the API (Sofosbuvir,
the API, reference standards and Batch No. 0051121/004/2016) Working Standard and
impurity standards? Impurity Standards.
5. Do you have GMP certificate of API Firm have copy of GMP certificate of M/s. Pharmagen Ltd.
manufacturer issued by regulatory Lahore issued by DDG Lahore (DRAP).
authority of country of origin?
6. Do you use API manufacturer method Firm have used API manufacturer method of testing for
of testing for testing API? testing API (Sofosbuvir).
7. Do you have stability studies reports Firm have shown copy of 06 Months (Accelerated) and 12
on API? Months (Real Time) Stability Study Reports on 03 Batches
of API (Sofosbuvir) conducted by the API Manufacturer
(M/s Pharmagen Ltd. Lahore).
8. If yes, whether the stability testing has Stability testing has been performed as per SIM method and
been performed as per SIM method degradation products have been quantified.
and degradation products have been
quantified?
9. Do you have method for quantifying Firm have used API Manufacturer‘s (M/s Pharmagen Ltd.
the impurities in the API? Lahore) method for quantifying the impurities in the API
(Sofosbuvir).
10. Do you have some remaining Firm have some remaining quantities of the API
quantities of the API, its reference (Sofosbuvir), its working standard and impurity standards.
11. Have you used pharmaceutical grade Firm have used pharmaceutical grade excipients as claimed
excipients? on COAs of excipients used.
12. Do you have documents confirming Firm have shown local purchase invoices of the used
the import of the used excipients? excipients.
DRAP Clearance is not available since the firm have
purchased all excipients locally.
13. Do you have test reports and other Firm have test reports and other records on the excipients
14. Do you have written and authorized Firm have written and authorized protocol for the
protocols for the development of development of NUVALDI Tablets 400mg (Sofosbuvir).
applied product?
15. Have you performed Drug-excipients Firm have performed Drug-excipients compatibility studies
compatibility studies? retrospectively in March 2018.
16. Have you performed comparative Firm have performed comparative dissolution studies of their
dissolution studies? product with reference product (Sovaldi Tablets 400mg
Manufactured by Gilead Sciences Inc. and Marketed by M.s
Ferozsons Labs). Details are as follows:
Details Test Reference

Product Product
Brand NUVALDI SOVALDI
Batch No. SFCT-003A VVDCD
Mfg. Date Nov-2016 04-2016
Dissolution pH 1.2 pH 1.2
Medium pH 4.5 pH 4.5
pH 6.8 pH 6.8
Test product showed comparable dissolution profile with the

reference product.
17. Do you have product development Firm have used Production Area for development of Stability
(R&D) section? Batches.
The firm informed that their Product development
(R&D) section is being upgraded.
18. Do you have necessary equipment Firm have used Production Area for development of Stability
available in product development Batches.
section for development of applied Necessary equipment are available in Production Area
product? for development of applied product.
19. Are the equipment in product Firm have used Production Area for development of Stability
development section qualified? Batches.
Necessary equipment available in Production Area for
development of applied product are qualified.
20. Do you have proper maintenance / Firm have used Production Area for development of Stability
calibration / re-qualification program Batches.
for the equipment used in PD section? Firm have proper maintenance / calibration / re-
qualification program for the equipment used in
Production Area for development of applied product.
21. Do you have qualified staff in product Firm have trained & qualified staff of 05 technical persons
development section with proper including 04 Pharmacist and 01 Chemist involved in Product
knowledge and training in product Development (R&D).
development?
22. Have you manufactured three stability Three stability batches have been manufactured in Nov-2016
batches for the stability studies of for the stability studies of Nuvaldi Tablets 400mg with batch
applied product as required? numbers SFCT-003A, SFCT-003B and SFCT-003C having
batch size of 2,497 Tablets each.
23. Do you have any criteria for fixing the Firm have informed that they have followed DRAP‘s criteria
batch size of stability batches? for fixing batch size of stability batches.
The firm was further advised to develop an SOP for
defining criteria for fixing the batch size of stability
batches.
24. Do you have complete record of Firm have shown record of production of stability batches.
production of stability batches?
25. Do you have protocols for stability Firm have detailed protocols for stability testing of stability
testing of stability batches? batches.
26. Do you have developed and validated Firm have developed and validated the method for testing of
the method for testing of stability stability batches.
batches?
27. Do you have method transfer studies Not applicable.
in case when the method of testing
being used by your firm is given by Firm have developed and validated the method for testing of
any other lab? stability batches.
28. Do you have documents confirming Firm have documents confirming the qualification of
the qualification of equipment / equipment / instruments being used in the test and analysis of
instruments being used in the test and API and the finished drug.
analysis of API and the finished drug?
29. Is your method of analysis stability Firm‘s method of analysis is stability indicating and
indicating? impurities were tested as per API Manufacturer‘s method.
30. Is your HPLC software 21CFR Firm have used HPLC system from KNAUR (Germany) for
Compliant? testing of stability batches. Software ClarityChrom® which
is 21CFR Compliant.
02 Users (QCM - Mr. Shahzad and Analyst - Ms. Sumbul)
have access to the HPLC software as observed at the time of
inspection.
However the analyst had access to QCM’s account as
well. The firm was advised to change this practice at
once.
31. Can you show Audit trail reports on Firm have shown audit trail reports on stability study testing.
stability study testing? Currently 12 Months Real Time Stability Testing have been
performed.
32. Do you have some remaining Firm have some remaining quantities of degradation
quantities of degradation products and products and stability batches.
stability batches?
33. Do you have stability batches kept on Firm has three stability batches kept on Real Time Stability
stability testing? Testing. Currently 12 Months Real Time Stability Testing
have been completed.
34. Do you have valid calibration status Firm have valid calibration status for the equipment used in
for the equipment used in production production and analysis.
and analysis?
35. Do proper and continuous monitoring Adequate monitoring and control are available for stability
and control are available for stability chambers (MEMMERT - Germany and Galvano Scientific
chamber? 400-LA). Digital Data Loggers are also placed in stability
chambers for monitoring.
36. Do related manufacturing area, Related manufacturing area, equipment, personnel and
equipment, personnel and utilities be utilities are as per cGMP compliance.
37. Registration Board advised the panel As per BMRs shown by the firm and questions asked from
to particularly confirm the claim of personnel involved in coating section, it was obvious that the
Mr. Hamid Raza (CEO of M/s Neutro firm had used aqueous film coating for trial batches.
Pharma) regarding aqueous film Comparative dissolution testing was performed on HPLC
coating of trial batches and dissolution 21CFR compliant system which was confirmed during
analysis from 21CFR compliant inspection.
HPLC system. However the Dissolution analysis for each time interval
tested was performed on UV Spectrophotometer which
was confirmed from Manual Log Books.
CONCLUSION:
On the basis of risk based approach the genuineness / authenticity of stability data submitted by the firm for
registration of NUVALDI Tablets 400mg (Sofosbuvir) is verifiable to satisfactory level. The related manufacturing
area, equipment, personnel and utilities are as per cGMP compliance.
As per BMRs shown by the firm and questions asked from personnel involved in coating section, it was obvious that
the firm had used aqueous film coating for trial batches. Comparative dissolution testing was performed on HPLC
21CFR compliant system which was confirmed during inspection. However the Dissolution analysis for each time
interval tested was performed on UV Spectrophotometer which was confirmed from Manual Log Books.
Decision: Registration Board decided to approve registration of “NUVALDI Tablets 400mg (Sofosbuvir) by
M/s. Neutro Pharma (Pvt.) Ltd., Lahore. Manufacturer will place first three production batches on long term
stability studies throughout proposed shelf life and on accelerated studies for six months
81. INVICTA (Sofosbuvir 400mg+ Velpatasvir 100 mg) Tablets
Report on Investigation of Authenticity / Genuineness of data submitted for registration of INVICTA

(Sofosbuvir 400mg+ Velpatasvir 100 mg) Tablets by M/s. Ferozsons Laboratories Nowshera.
Reference No: F.2- 16/2016- PEC (M-277)

Investigation Date and Time: 16th March, 2018 (Evening)
Investigation Site: Factory premises of M/s. Ferozsons Laboratories Nowshera
Q. Questions Observations
No.
1 Do you have documents confirming the ●
Sofosbuvir was imorted vide Invoice # eXP
import of API including approval from /FLL/019/16-17 dated 29th July 2016 with the
DRAP? approval of DRAP peshawar office
● Velpatasvir was imported vide invoice number
E/16-17-7090000066 dated 31st Jan 2017 with the
approval of DRAP peshawar office ..
2 What was the rationale behind selecting the The firm selected APIs sources recommended by Innovator
particular manufacturer of API? M/S Gilead USA.
3 Do you have documents confirming the Firm has documents confirming the import of working
import of reference standard and impurity standards and impurities standards vide NOC # F-11-
standards? 1/2017-ferozsons DRAP (p) 525 dated10-3-2017, Performa
invoice #LLL/vsp1-16-17/287&17.02-2017, Impurities
each 15mg has been imported i.e. Imp E, Imp. A, AVPT-1,
BOCMMP, for Velpatasvir invoice number
IRS/VSPI/AVPT/16/082.
4 Do you have certificate of Analysis of the The firm has COAs of API, reference standards and
API, reference standards and impurity impurities standards by LAURUS Lab and Sequent
standards? scientific Ltd as mentioned in Clause 2.
5 Do you have GMP certificate of API The firm has GMP certificates of Both Manufacturer i.e.
manufacturer issued by regulatory authority LAURUS and Sequent Scientific Ltd and are valid until
of country of origin? August 2018 and July 2018 respectively.
6 Do you use API manufacturer method of The firm has adopted same method of analysis as of
testing? manufacturer for both APIs.
7 Do you have stability studies reports on The firm has stability report for both APIs provided by the
API? manufacturer.
Sofosbuvir : IRD15/SFB-18, IRD15/SFB-19,PS066414
Velpatasvir AVPS-1/VSP3/004/17, AVPS-1/VSP3/005/17,
AVPS-1/VSP3/006/17.
8 If yes, whether the stability testing has been Firm has reports for API stability testing showing
performed as per SIM method and quantification of Degradation products.
degradation products have been quantified?
9 Do you have method for quantifying the The firm has method for the quantification of impurities
impurities in the API? which were found with in specified limits.
10 Do you have some remaining quantities of The firm has record of remaining quantities of APIs,
the API, its reference standard and reference standards and impurities standards.
11 Have you used pharmaceutical
grade Firm has used following excipients of pharmaceutical
excipients? grade:
1. Croscarmellose SodiumB.P (Invoice # 21371529)
2. Avicel pH 102B.P. ( invoice # 21371529)
3. Magnesium Stearate U.S.P.
4. Opadry Orange (200F230017)
12 Do you have documents confirming the The firm has the document confirming import of the
import of the used excipients? material as mentioned in 11.
13 Do you have test reports and other records The firm has the complete Testing records for the
on the excipients used? excipients used in the formulation.
14 Do you have written and authorized The firm has written, authorized protocols for the
protocols for the development? development of Product.
15 Have you performed Drug-excipient The firm have adopted formulation provided by the
compatibility studies? innovator i.e. Gilead.
16 Have you performedcomparative The firm has performed comparative dissolution with the
dissolution studies? reference product of Innovator i.e. EPCLUSA batch
number DU1502B 1D. The study was satisfactory.
17 Do you have product development (R&D) The firm has Product development unit for Solids, semi
section solids and oral Liquid.
18 Do you have necessary equipment available The firm has all relevant equipment required for the
in product development section for product development.
development?
19 Are the equipment in product development Yes all equipment used for the product development are
section qualified? Qualified.
20 Do you have proper maintenance / The firm has a proper maintenance / Calibration and
calibration / re-qualification program for the requalification plan for PD section.
equipment used in PD section?
21 Do you have qualified staff in product The firm has 3 qualified Pharmacists in PD section.
development section with proper knowledge 2 Pharm D and 1 M. Pharm with experience ranging from 3
and training in product development? to 18 years.
22 Have you manufactured three stability Firm has manufactured three stability batches with Batch
batches for the stability studies as required? size of 2500 tablets each, batch numbers are:
1. PD 17N016
2. PD 17N017
3. PD 17N018
23 Do you have any criteria for fixing the batch The firm they have manufactured batch sizes as per DRAP
size of stability batches? letter # F,3-2/2014.I&E dated Dec 8th 2015.
24 Do you have complete record of production The firm has complete record supporting production of
of stability batches? stability batches.
25 Do you have protocols for stability testing of The firm has detailed protocols for the stability testing of
stability batches? the batches produced.
26 Do you have developed and validated the Firm has properly validated method of testing for stability
method for testing of stability batches? batches manufactured.
27 Do you have method transfer studies in case
when the method of testing being used by N.A
your firm is given by any other lab?
28 Do you have documents confirming the Firm has all relevant documents confirming the
qualification of equipment / instruments qualification of equipment‘s used.
being used in the test and analysis of API
and the finished drug?
29 Is your method of analysis is stability Method of testing used for analysis of stability batches
indicating? were ―Stability Indicating.‖
30 Do your HPLC software 21CFR Compliant? The HPLC software is 21CFR Compliant as per record
available with the firm.
31 Can you show Audit trail reports on testing? A proper audit trail was available to show compliance.
32 Do you have some remaining quantities of ● No remaining quantities of degradation products is
degradation products and stability batches? reported.
● A proper reconciliation of stability batches was
provided as record showing remaining quantities.
33 Do you have commitment batches kept on The firm has kept remaining quantities of stability batches
stability testing? in stability chambers for real time study.
34 Do you have valid calibration status for the

Valid calibrated equipment were used for the production
equipment used in production and analysis?and analysis.
35 Do proper and continuous monitoring and The firm has stability chambers equipped with Continuous
control are available for stability chamber?
monitoring controls and hard copies of the record were
inspected and found compliant.
36 Do related manufacturing area, equipment, Related manufacturing area equipment, personal and
personnel and utilities be rated as GMP utilities were found to be GMP compliant.
compliant?
Conclusion: On the basis of risk based approach the genuineness/ authenticity of stability data submitted by the firm
for registration of INVICTA (Sofosbuvir 400mg+ Velpatasvir 100 mg) Tablets is verifiable to satisfactory level.
Related manufacturing area, equipments, personnel and utilities are rated as satisfactory. The firm has also
submitted commitment for post-registration bioequivalence studies of INVICTA (Sofosbuvir 400mg+
Velpatasvir 100 mg) Tablets since Velpatasvir falls in BCS Class-IV.
Decision: Registration Board decided to approve registration of “INVICTA (Sofosbuvir 400mg+ Velpatasvir
100 mg) Tablets by M/s. Ferozsons Laboratories Nowshera. Manufacturer will place first three
production batches on long term stability studies throughout proposed shelf life and on accelerated
82. LEDISA (Sofosbuvir 400mg+ Ledipasvir 90mg) Tablets
Report on Investigation of Authenticity / Genuineness of data submitted for registration of LEDISA
(Sofosbuvir 400mg+ Ledipasvir 90mg) Tablets by M/s. Ferozsons Laboratories Nowshera.
Reference No: F.2- 16/2016- PEC (M-277)
Investigation Date and Time: 16thMarch, 2018 (Morning)
Investigation Site: Factory premises of M/s. Ferozsons Laboratories Nowshera
Q. Questions Observations
No.
1 Do you have documents confirming the ●
Sofosbuvir was imported vide Invoice # EXP
import of API including approval from /LLM/010/15-16 DATED 03-02-2016
DRAP? ● Ledipasvir was imported vide invoice number
EXP/FLL003/16-17dated 14-5-2016
2 What was the rationale behind selecting The firm selected APIs sources recommended by Innovator M/S
the particular manufacturer of API? Gilead USA.
3 Do you have documents confirming the The firm has documents confirming the import of working
import of reference standard and standards and impurities standards vide Ref # 20865 dated 8-9-
impurity standards? 2016, Impurities each 15mg has been imported i.e.
Imp 1, Imp.2, For Ledipasvir invoice number
SGIPL/FLL/057/16-17 dated 8-12-16.
4 Do you have certificate of Analysis of The firm has COAs of APIs, reference standards and impurities
the API, reference standards and standards By Sequent scientific Ltd as mentioned in Clause 2.
impurity standards?
5 Do you have GMP certificate of API The firm has GMP certificates of Manufacturer i.e. Sequent
manufacturer issued by regulatory Scientific Ltd and was found valid until July 2018.
authority of country of origin?
6 Do you use API manufacturer method The firm has adopted same methods of analysis as of
of testing? manufacturer for both APIs.
7 Do you have stability studies reports on The firm has stability report for both APIs provided by the
API? manufacturer.
Sofosbuvir : IRD15/SFB-18, IRD15/SFB-19,PS066414
Ledipasvir : LPR1507003, LPR1507004,LPR1507005
8 If yes, whether the stability testing has The firm has reports for API stability testing showing
been performed as per SIM method and quantification of Degradation products.
degradation products have been
quantified?
9 Do you have method for quantifying The firm has methods for the quantification of impurities and
the impurities in the API? impurities were in specified limits.
10 Do you have some remaining quantities Firm has record of remaining quantities of APIs, reference
of the API, its reference standard and standards and impurities standards.
11 Have you used pharmaceutical grade Firm has used following excipients of pharmaceutical grade:
excipients? 1. Croscarmellose Sodium B.P (Invoice # 21371529)
2. Avicel pH 102 B.P. ( invoice # 21371529)
3. Magnesium Stearate U.S.P.
4. Aerosil 200 B.P.
5. Opadry Pink (200F240048)
12 Do you have documents confirming the The firm has the document confirming import of the materials as
import of the used excipients? mentioned in 11.
13 Do you have test reports and other The firm has the complete Testing records for the excipients
records on the excipients used? used in the formulation.
14 Do you have written and authorized The firm has written, authorized protocols for the development
protocols for the development? of Product.
15 Have you performed Drug-excipient The firm have adopted formulation provided by the innovator
compatibility studies? i.e. Gilead.
16 Have you performed comparative The firm has performed comparative dissolution with the
dissolution studies? reference product of Innovator i.e. HARVONI batch number
DK1402B1D. Results were found within limits.
17 Do you have product development The firm has Product development unit for Solids, semi solids
(R&D) section and oral Liquid.
18 Do you have necessary equipment The firm has all relevant equipment required for the product
available in product development development.
section for development?
19 Are the equipment in product Yes, all equipment used for the product development are
development section qualified? Qualified.
20 Do you have proper maintenance / The firm has a proper maintenance / Calibration and
calibration / re-qualification program requalification plan for the equipment of PD section.
for the equipment used in PD section?
21 Do you have qualified staff in product The firm has 3 qualified Pharmacists in PD section. 2
development section with proper Pharm D and 1 M. Pharm with experience ranging from 3- years
knowledge and training in product to 18 years.
development?
22 Have you manufactured three stability The firm has manufactured three stability batches as required
batches for the stability studies as with Batch size of 2500 tablets each, batch numbers are:
required? 1. PD 16N007
2. PD 16N008
3. PD 16N009
23 Do you have any criteria for fixing the The firm they have manufactured Batch sizes as per DRAP
batch size of stability batches? letter # F,3-2/2014.I&E dated Dec 8th 2015.
24 Do you have complete record of The firm has complete record supporting production of stability
production of stability batches? batches.
25 Do you have protocols for stability The firm has detailed protocols for the stability testing of the
testing of stability batches? batches produced.
26 Do you have developed and validated Firm has properly validated method of testing for stability
the method for testing of stability batches manufactured.
batches?
27 Do you have method transfer studies in
case when the method of testing being N.A
used by your firm is given by any other
lab?
28 Do you have documents confirming the
qualification of equipment / Firm has all relevant records showing qualification of equipment
instruments being used in the test and used in manufacturing and testing.
analysis of API and the finished drug?
29 Is your method of analysis is stability Method of testing used for analysis of stability batches are
indicating? ―Stability Indicating.‖
30 Do your HPLC software 21CFR The HPLC software is 21CFR Compliant as per record available
Compliant? with the firm.
31 Can you show Audit trail reports on A proper audit trail was available to show compliance.
testing?
32 Do you have some remaining quantities No remaining quantities of degradation products and API is
of degradation products and stability reported.
batches?
33 Do you have commitment batches kept The firm has kept remaining quantities of stability batches in
on stability testing? stability chambers for real time study.
34 Do you have valid calibration status for Valid calibrated equipment were used for the production and
the equipment used in production and analysis.
analysis?
35 Do proper and continuous monitoring The firm has stability chambers equipped with Continuous
and control are available for stability monitoring controls and hard copies of the record were
chamber? inspected and found compliant.
36 Do related manufacturing area, The related manufacturing area equipment, personal and utilities
equipment, personnel and utilities be were found t to be GMP compliant.
Conclusion: On the basis of risk based approach the genuineness/ authenticity of stability data submitted by the firm
for registration of LEDISA (Sofosbuvir 400mg+ Ledipasvir 90mg) Tablets is verifiable to satisfactory level. Related
manufacturing area, equipments, personnel and utilities are rated as satisfactory.
Decision: Registration Board decided to approve registration of “LEDISA (Sofosbuvir 400mg+ Ledipasvir
90mg) Tablets by M/s. Ferozsons Laboratories Nowshera. Manufacturer will place first three production
batches on long term stability studies throughout proposed shelf life and on accelerated studies for six
months.
83. Diarosec 10mg sachet (Racecadotril)

Report on Inspection of Authenticity / Genuineness of data submitted for registration of Diarosec 10mg sachet
(Racecadotril) by M/s. Vision Pharmaceuticals (Pvt.) Ltd., Plot No. 22 - 23, Industrial Estate, Kahuta road,
Model Town, Islamabad.
Inspection Date and Time: 23rd February, 2018 (Morning)
Inspection Site: Vision Pharmaceuticals (Pvt.) Ltd., Plot No. 22 - 23, Industrial Estate, Kahuta road,
Background:
Registration Board in 275th meeting vide letter No. F.2-16/2016-PEC (M-275) meeting considered the
applications of M/s. Vision Pharmaceuticals (Pvt.) Ltd., Plot No. 22 - 23, Industrial Estate, Kahuta Road,
Model Town, Islamabad. for registration of Diarosec 10mg sachet. Registration Board considered scientifically
rational laboratory scale data submitted by the firm as pre-requisite of registration being new formulation and
constituted a three member panel to verify the authenticity / genuineness of data (import of raw material and stability
data). Panel was advised to conduct inspection of the firm as per decision of Registration Board and to submit report
for further consideration.
1. Dr. Muhammad Fakhruddin Aamir, Additional Director (QA&LT), DRAP, Islamabad
2. Mr. Muhammad Amin, Deputy Director, Division of PE&R, DRAP, Islamabad
3. Mr. Arslan Tariq, FID-I (Islamabad), DRAP, Islamabad.
Scope of inspection:
Inspection of the authenticity / genuineness of data (import of raw material and stability data),
Tools for Inspection:
The inspection was conducted by using a structured questionnaire of DRAP. For objective evidence 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 were also audited. The details
of inspection may be summarized as under:
Detail of Inspection:
Q. No. Question Observation by panel

1. Do you have documents confirming the Firm has imported 02 Kg of Racecadotril from M/S.
import of API including approval from Rampex Labs Pvt Ltd. India vide Invoice No. RMPN-
DRAP? 2/TXP/20/15-16/044 on 29/03/2016, and has obtained
clearance for its import vide No. 1366/16 dated 17.05.2016
from DRAP Islamabad. The 1.565Kg API has been used in
manufacturing of 03 batches each for Diarosec 10mg
Sachet, Diarosec 30mg Sachet and Diarosec 100mg
Capsule.
2. What was the rationale behind selecting the Selection of the manufacturer for Racecadotril has been
particular manufacturer of API? made as per internal SOP for vendor qualification. The
criteria includes GMP certification of API manufacturer
from the country of origin, CoA of API, Reference
Standard and impurities (if any), supply of Reference
Standards and Impurity Standards, stability study report
on API, method of quantifying impurities, DMF from
supplier (open part) and has provided documents for
Stability, Method of Analysis, Material Safety and Data
Sheets.
3. Do you have documents confirming the The firm imported working standards of the API vide
import of Racecadotril reference standard indenter Progressive associates and the major impurity A is
and impurity standards? imported from EP vide proper import documents.
4. Do you have certificate of Analysis of the The firm has certificates of analysis for the API, working
API, reference standards and impurity standard and for major impurity standard.
standards?
5. Do you have any approval of API or GMP The firm has GMP certificate of the API manufacturer
certificate of API manufacturer issued by issued by regulatory authority of country of Origin. Also
regulatory authority of country of origin? the product list is verifiable from the web site of Rampex
labs India.
6. Do you use API manufacturer method of The firm is using API manufacturer method of testing.
testing?
7. Do you have stability studies reports on The firm has accelerated stability studies reports of six
API? months and real time stability studies report on the API
(Racecadotril) conducted by the API manufacturer.
performed as per SIM method and method and degradation products have been quantified.
9. Do you have method for quantifying the The firm has method for quantifying the impurities in the
impurities in the API? API.
the API, its reference standard and standard of API and the major impurity. All these material
impurities standards? have been checked physically and found in order.
11. Have you used pharmaceutical grade The firm has used pharmaceutical grade excipients.
excipients?
12. Do you have documents confirming the The firm has imported some of the excipients, whereas,
import of the used excipients? some are procured from local indenters providing COA of
excipient issued by principal manufacturers. The imported
excipients have proper import documents.
13. Do you have test reports and other records The firm has test reports and other records on the
on the excipients used? excipients used.
protocols for the development of Diarosec development of Diarosec 10mg sachet (Racecadotril).
10mg sachets?
15. Have you performed Drug-excipients The firm has not performed Drug-excipients compatibility
compatibility studies? studies and used pharmaceutical grade excipients.
16. Have you performed comparative Since the comparative dissolution study is Not Applicable
dissolution studies? to sachet dosage form. Therefore, the firm has not
performed the study. However, Comparative Analysis
(Assay & pH) study between the Diarosec 10mg sachet vs.
Hidrasec 30 mg Sachet (Manufactured by Laboratories
SOPHRATEX, 21, rue du Pressoir 28500, Vernouillet,
France; Importer: Abbott Laboratories, Ltd., Bankok) is
performed as additional measure and the results obtained
from the study are comparable to that of the Hidrasec
30mg Sachet (Manufacturer by Laboratories
SOPHRATEX, 21, rue du pressoir 28500, Vernouillet,
France; Importer: Abbott Laboratories, Ltd., Bankok).
17. Do you have product development (R&D) The firm has dedicated area for manufacturing of trial
section batches. However the manufacturing of trial batches has
been carried out in qualified equipments used for
commercial production. The QC part/ analytical testing
were conducted by dedicated & calibrated equipments in
QC lab.
18. Do you have necessary equipment‘s The firm has necessary equipment for production of trial
available in product development section batches in product development section; however, the
for development of Hidrasec 10mg sachet? manufacturing of trial batches has been carried out in
qualified equipments used for commercial production and
the analytical part has been performed via dedicated &
calibrated equipments in quality control laboratory.
19. Are the equipments in product The equipment used in production and analysis of trial
20. Do you have proper maintenance / The firm has SOP for maintenance / calibration / re-
calibration / re-qualification program for qualification program for the equipment used in production
the equipment used in PD section? and QC of trial batches of Sachet dosage form which was
found implemented.
21. Do you have qualified staff in product The firm has appointed a team of 03 pharmacists in
development section with proper Product development section and 02 pharmacists for
knowledge and training in product Quality Control section exclusive for R&D trial batches.
development?
22. Have you manufactured three stability The firm has manufactured three stability batches for the
batches for the stability studies of Diarosec stability studies of Diarosec 10mg sachet with batch
10mg sachet as required? numbers NPD601 (T-01), NPD601
(T-02) and NPD601 (T-03) with theoretical batch size of
282, 288 and 284 sachets, respectively.
23. Do you have any criteria for fixing the The criteria for fixing the batch size of stability batches is
batch size of stability batches? the number of sachets per testing frequency and number of
testing frequencies while keeping in view the decision of
Registration Board (RB) in its 249th Meeting.
24. Do you have complete record of production The firm has complete record of production of stability
of stability batches? batches. Necessary log books of equipment used has been
available with the firm, assuring the traceability of
manufacturing and analysis of stability batches.
25. Do you have protocols for stability testing The firm has controlled protocol and reports of testing of
of stability batches? stability batches with them.
26. Do you have developed and validated the The firm has used method of testing of API manufacturer
method for testing of stability batches? for related substances for stability testing of their finished
product (Sachets).The method is gradient mode and
stability indicating and has validated while using the
working standard of API, impurities and forced
27. Do you have method transfer studies in The firm has not conducted method transfer studies;
case when the method of testing being used however, they have validated their method.
by your firm is given by any other lab?
28. Do you have documents confirming the The firm has documents confirming the qualification of
qualification of equipments / instruments equipment / instruments being used in the test and analysis
being used in the test and analysis of of Racecadotril API and the finished drug Diarosec 10mg
Racecadotril API and the finished drug sachet.
(Diarosec 10mg sachet)?
30. Do your HPLC software is 21CFR Firm has 01 HPLC dedicated for R&D testing and is 21
compliant? CFR II compliant. This HPLC system is used for stability
studies of Diarosec 10mg sachet. The HPLC used for the
stability studies upto 06 months studies on software which
is not 21CFR II compliant, however the record from
logbooks, analytical test reports was verifiable onsite.
Whereas, the rest of 09, 12 and 18 months studies testing
was carried out as 21 CFR II compliant. A complete trail
of such testing was available and verifiable.
31. Can you show Audit Trail reports on Audit trail on the testing reports can be made from 09, 12,
Diarosec sachet testing? and 18 months studies.
32. Do you have some remaining quantities of The firm has remaining quantities of stability batches,
degradation products and stability batches? however, there is no quantity of degradation products.
33. Do you have stability batches kept on The firm has completed the accelerated stability testing on
stability testing? the three stability batches of Diarosec 10mg sachets. Also
the firm has successfully completed the real time stability
testing upto 18 months time points on all three batches
with satisfactory results.
34. Do you have valid calibration status for the The firm has valid calibration status for the equipment
equipment‘s used in Diarosec 10mg sachet used in Diarosec 10mg sachet production and analysis.
production in analysis?
35. Do proper and continuous monitoring and Continuous power supply and monitoring with back up
control are available for stability chamber? from generator are available for stability chamber. That is
in case of load shedding start up time of the generator is
within 02 minutes as demonstrated during the onsite
inspection.
36. Do related manufacturing area, equipment, The related manufacturing area, equipment, personnel and
personnel and utilities be rated as GMP utilities are rated as GMP compliant.
compliant?
Conclusions & Recommendations:

1. On the basis of risk based approach the genuineness / authenticity of stability data submitted by the firm
for registration of Diarosec 10mg sachet (Racecadotril) is verifiable to satisfactory level.
2. The related manufacturing area, equipments, personnel and utilities are GMP compliant and suitable for
the manufacturing of Diarosec 10mg sachet, therefore, the panel recommends the registration of Diarosec
10mg sachet in the name of the manufacturer.
Decision: Registration Board decided to approve registration of “Diarosec 10mg sachet (Racecadotril) by M/s.
Vision Pharmaceuticals (Pvt.) Ltd., Plot No. 22 - 23, Industrial Estate, Kahuta road, Model Town,
Islamabad. Manufacturer will place first three production batches on long term stability studies
throughout proposed shelf life and on accelerated studies for six months
84. Diarosec 30mg sachet (Racecadotril)
Report on Inspection of Authenticity / Genuineness of data submitted for registration of Diarosec 30mg sachet
(Racecadotril) by M/s. Vision Pharmaceuticals (Pvt.) Ltd., Plot No. 22 - 23, Industrial Estate, Kahuta road,
Background:
Model Town, Islamabad. for registration of Diarosec 30mg sachet. Registration Board considered scientifically
Scope of Inspection:
The inspection was conducted by using a structured questionnaire of DRAP. For objective evidence physical
of inspection may be summarized as under:

import of API including approval from Rampex labs pvt ltd. India vide Invoice letter No. RMPN-
DRAP? 2/TXP/20/15-16/044 on 29/03/2016, and has obtained
clearance for its import vide No. 1366/16 dated 17.05.2016
from DRAP Islamabad. The 1.565Kg API has been used in
manufacturing of 03 batches each for Diarosec 10mg
sachet, Diarosec 30mg Sachet and Diarosec 100mg
Capsule.
Sheets.
import of Racecadotril reference standard indenter Progressive associates and the major impurity A is
and impurity standards? imported from EP vide import documents.
standards?
labs India.
testing?
the API, its reference standard and standard of API and the major impurity. All these material
impurities standards? have been checked physically and found in order.
excipients?
import of the used excipients? some are procured from local indenters providing COA of
excipient issued by principal manufacturers. The imported
excipients have import documents.
protocols for the development of Diarosec development of Diarosec 30mg sachet (Racecadotril).
30mg sachets?
15. Have you performed Drug-excipients The firm has not performed Drug-excipients compatibility
compatibility studies? studies and used pharmaceutical grade excipients.
16. Have you performed comparative Since the comparative dissolution study is Not Applicable
dissolution studies? to sachet dosage form. Therefore, the firm has not
performed the study. However, Comparative Analysis
(Assay & pH) study between the Diarosec 30mg sachet vs.
Hidrasec 30 mg sachet (Manufactured by Laboratories
France; Importer: Abbott Laboratories, Ltd., Bankok) is
performed as additional measure and the results obtained
from the study are comparable to that of the Hidrasec
30mg Sachet (Manufacturer by Laboratories
QC lab.
for development of Diarosec (Racecadotril) manufacturing of trial batches has been carried out in
30mg sachet? qualified equipments used for commercial production and
the analytical part has been performed via dedicated &
calibrated equipments in quality control laboratory.
calibration / re-qualification program for qualification program for the equipment used in production
the equipment used in PD section? and QC of trial batches of Sachet dosage form which was
found implemented.
development?
batches for the stability studies of Diarosec stability studies of Diarosec 30mg sachet with batch
30mg sachet as required? numbers NPD601 (T-01), NPD601
(T-02) and NPD601 (T-03) with actual batch size of 271,
280 and 274 sachets, respectively.
batch size of stability batches? the number of sachets per testing frequency and number of
testing frequencies while keeping in view the decision of
Registration Board (RB) in its 249th Meeting.
of stability batches? batches. Necessary log books of equipment used has been
available with the firm, assuring the traceability of
product (Sachets).The method is gradient mode and
qualification of equipments / instruments equipment / instruments being used in the test and analysis
being used in the test and analysis of of Racecadotril API and the finished drug Diarosec 30mg
Racecadotril API and the finished drug sachet.
(Diarosec 30mg sachet)?
studies of Diarosec 30mg sachet. The HPLC used for the
stability studies upto 06 months studies on software which
is not 21CFR II compliant, however the record from
Whereas, the rest of 09, 12 and 18 months studies testing
was carried out as 21 CFR II compliant. A complete trail
of such testing was available and verifiable.
31. Can you show Audit Trail reports on Audit trail on the testing reports can be made from 09, 12,
Diarosec sachet testing? and 18 months studies.
33. Do you have stability batches kept on The firm has completed the accelerated stability testing on
stability testing? the three stability batches of Diarosec 30mg sachets. Also
the firm has completed the real time stability testing upto
18 months time points on all three batches with
satisfactory results.
equipment‘s used in Diarosec 30mg sachet used in Diarosec 30mg sachet production and analysis.
production in analysis?
control are available for stability chamber? from generator are available for stability chamber. That is
in case of load shedding start up time of the generator is
within 02 minutes as demonstrated during the onsite
inspection.
36. Do related manufacturing area, equipment, The related manufacturing area, equipment, personnel and
personnel and utilities be rated as GMP utilities are rated as GMP compliant.
compliant?

1. On the basis of risk based approach the genuineness / authenticity of stability data submitted by the firm
for registration of Diarosec 30mg sachet (Racecadotril) is verifiable to satisfactory level.
2. The related manufacturing area, equipments, personnel and utilities are GMP compliant and suitable for
the manufacturing of Diarosec 30mg sachet, therefore, the panel recommends the registration of Diarosec
30mg sachet in the name of the manufacturer.
Decision: Registration Board decided to approve registration of “Diarosec 30mg sachet (Racecadotril) by M/s.
Vision Pharmaceuticals (Pvt.) Ltd., Plot No. 22 - 23, Industrial Estate, Kahuta road, Model Town,
85. Diarosec 100mg Capsule (Racecadotril)
Report on Inspection of Authenticity / Genuineness of data submitted for registration of Diarosec 100mg
Capsule (Racecadotril) by M/s. Vision Pharmaceuticals (Pvt.) Ltd., Plot No. 22 - 23, Industrial Estate, Kahuta
road, Model Town, Islamabad.
Background:
Model Town, Islamabad. for registration of Diarosec 100mg Capsule. Registration Board considered scientifically
The Inspection was conducted by using a structured questionnaire of DRAP. For objective evidence physical
of Inspection may be summarized as under:

import of API including approval from Rampex labs pvt ltd. India vide Invoice letter No.
DRAP? RMPN-2/TXP/20/15-16/044 on 29/03/2016, and has
obtained clearance for its import vide No. 1366/16 dated
17.05.2016 from DRAP Islamabad. The 1.565Kg API
has been used in manufacturing of 03 batches each for
Diarosec 10mg sachet, Diarosec 30mg Sachet and
Diarosec 100mg Capsule.
Sheets.
import of Racecadotril reference standard indenter Progressive associates and the major impurity A
and impurity standards? is imported from EP vide proper import documents.
standards?
labs India.
testing?
the API, its reference standard and standard of API and the major impurity. All these
impurities standards? material have been checked physically and found in
order.
excipients?
import of the used excipients? some are procured from local indenters. The imported
excipients have proper import documents.
protocols for the development of Diarosec development of Diarosec 100mg Capsules
100mg Capsules? (Racecadotril).
15. Have you performed Drug-excipients The firm has not performed Drug-excipients
compatibility studies? compatibility studies and used pharmaceutical grade
excipients.
dissolution studies? with Hidrasec 100mg Capsules (Manufactured by
Laboratories SOPHRATEX, 21, rue du Pressoir 28500,
Vernouillet, France; Importer: Abbott Laboratories, Ltd.,
Bankok) on 6 baskets Dissolution Apparatus. The results
obtained from the study are comparable to that of the
Hidrasec 100mg Capsule (Manufactured by Laboratories
QC lab.
for development of Diarosec 100mg manufacturing of trial batches has been carried out in
Capsules? qualified equipments used for commercial production
and the analytical part has been performed via dedicated
& calibrated equipments in quality control laboratory.
calibration / re-qualification program for qualification program for the equipment used in
the equipment used in PD section? production and QC of trial batches of Sachet dosage form
which was found implemented.
development?
batches for the stability studies of Diarosec stability studies of Diarosec 100mg Capsule with batch
100mg Capsules as required? numbers NPD611 (T-01), NPD611
(T-02) and NPD611 (T-03) with theoretical batch size of
1070, 1050 and 1040 Capsules, respectively.
batch size of stability batches? the number of sachets per testing frequency and number
of testing frequencies while keeping in view the decision
of Registration Board (RB) in its 249th Meeting.
of stability batches? batches. Necessary log books of equipment used has
been available with the firm, assuring the traceability of
product (Capsules).The method is gradient mode and
qualification of equipments / instruments equipment / instruments being used in the test and
being used in the test and analysis of analysis of Racecadotril API and the finished drug
Racecadotril API and the finished drug Diarosec 100mg Capsule.
(Diarosec 100mg capsules)?
studies of Diarosec 100mg Capsule. The HPLC used for
the stability studies upto 06 months studies on software
which is not 21CFR II compliant, however the record
from logbooks, analytical test reports was verifiable
onsite. Whereas, the rest of 09, 12 and 18 months studies
testing was carried out as 21 CFR II compliant. A
complete trail of such testing was available and
verifiable.
31. Can you show Audit Trail reports on Audit trail on the testing reports can be made from 09,
Diarosec capsules testing? 12, and 18 months studies.
stability testing? on the three stability batches of Diarosec 100mg Capsule.
Also the firm has successfully completed the real time
stability testing upto 18 months time points on all three
batches with satisfactory results.
equipment‘s used in Diarosec 100mg used in Diarosec 100mg Capsule production and
Capsules production in analysis? analysis.
control are available for stability chamber? from generator are available for stability chamber. That
is in case of load shedding start up time of the generator
is within 02 minutes as demonstrated during the onsite
inspection.
personnel and utilities be rated as GMP and utilities are rated as GMP compliant.
compliant?

1. On the basis of risk based approach the genuineness / authenticity of stability data submitted by
the firm for registration of Diarosec 100mg Capsules (Racecadotril) is verifiable to satisfactory
level. `
2. The related manufacturing area, equipments, personnel and utilities are GMP compliant and well
suited for the manufacturing of Diarosec 100mg capsules , therefore, the panel recommends the
registration of Diarosec 100mg capsules in the name of the manufacturer.
3. The comparative dissolution studies have been conducted by the firm on Diarosec 100mg
Capsules with the Hirdasec 100mg capsules (Manufactured by Laboratories SOPHRATEX, 21,
rue du Pressoir 28500, Vernouillet, France; Importer: Abbott Laboratories, Ltd., Bankok).
The Dissolution Profile has been carried out by the firm using 21 CFR II 09, 12 and 18 months studies
testing was carried out as 21 CFR II compliant. A complete trail of such testing was available
and verifiable. The HPLC used for the stability studies upto 06 months studies on software
which is not 21CFR II compliant, however the record from logbooks, analytical test reports was
verifiable onsite.
Decision: Registration Board decided to approve registration of “Diarosec 100mg Capsules (Racecadotril) by
M/s. Vision Pharmaceuticals (Pvt.) Ltd., Plot No. 22 - 23, Industrial Estate, Kahuta road, Model Town,
86. ESONAP 500/20mg (Naproxen, Esomeprazole) Tablets
Report on Inspection of Authenticity / Genuineness of data submitted for registration of ESONAP 500/20mg
(Naproxen, Esomeprazole) Tablets by M/s. Vision Pharmaceuticals (Pvt.) Ltd., Plot No. 22 - 23, Industrial
Estate, Kahuta road, Model Town, Islamabad.
Reference No: F.2-16/2016-PEC (M-276) dated 15th January, 2018
Background:
Registration Board in 276th meeting vide letter No. F.2-16/2016-PEC (M-276) considered the applications of
M/s. Vision Pharmaceuticals (Pvt.) Ltd., Plot No. 22 - 23, Industrial Estate, Kahuta road, Model Town,
Islamabad for registration of Esonap Tablets. Registration Board considered scientifically rational laboratory scale
data submitted by the firm as pre-requisite of registration being new formulation and constituted a three member
panel to verify the authenticity / genuineness of data (import of raw material and stability data). Panel was advised to
conduct inspection of the firm as per decision of Registration Board and to submit report for further consideration.
The Inspection was conducted by using a structured questionnaire of DRAP. For objective evidence physical
of Inspection may be summarized as under:

1. Do you have documents confirming the Firm has imported 25.0 Kg of Naproxen and 500.0kg of
import of API including approval from Esomeprazole from M/S. Zhejiang charioteer China vide
DRAP? Invoice letter No. ME 169059 dated Apr 06 2016, and
Everest Organics Ltd vide Invoice No EXP/017/16-17 on
May 05 2016 respectively. The Firm has approval for its
import vide No. 1378 dated 18.05.2016 and import vide
No. 1342 dated 16.05.2016 from DRAP Islamabad
respectively. The 19.353Kg API of Naproxen while
1.007kg of Esomeprazole has been used in
manufacturing of 3 stability batches each of 7299 tablets
(Theoratical Yield), of Esonap 500/20mg tablets.
2. What was the rationale behind selecting the The firm has internal criteria for selection of API
particular manufacturer of API? manufacturer/supplier. The criteria includes GMP
certification of API manufacturer from the country of
origin, CoA of API, Reference Standard and impurities
(if any), supply of Reference Standards and Impurity
Standards, stability study report on API, method of
quantifying impurities, DMF from supplier (open part)
and has provided documents for Stability, Method of
Analysis, Material Safety and Data Sheets.
Further the selection of the manufacturer for Naproxen
Base was that the M/s Vision Pharma is already
importing Naproxen Sodium from same source for
another registered product (Naplex 550mg tablet). The
manufacturer has provided adequate sample for initial
testing for prequalification. Moreover, for
Esomeprazole, the firm has already importing tons of
same API from Everest Pharma India, and has never
faced issues with quality, documentation and availability
of the API. Therefore the sources were kept the same.
3. Do you have documents confirming the The firm imported PRIMARY reference standards of the
import of Naproxen & Esomeprazole both APIs from USP directly and the major impurity and
reference standard and impurity standards? Photocopy of documentary evidence for import of
reference standard was presented.
API, reference standards and impurity standard of API and major impurity.
standards?
5. Do you have any approval of API or GMP The firm has GMP certificates of the API manufacturers
certificate of API manufacturer issued by issued by regulatory authority of country of Origin. That
regulatory authority of country of origin? is for Naproxen Zhejiang China and for Esomeprazole
Everest Organics India.
6. Do you use API manufacturer method of The firm is using API manufacturer‘s method of testing.
testing?
(Naproxen and Esomeprazole) conducted by the API
manufacturer.
impurities in the API? APIs both for Naproxen and Esomeprazole.
the API, its reference standard and standard of API and the major impurity. All these
impurities standards? material have been checked physically and found in
order.
excipients? Certificate of Analysis of same batches of excipients
used in product development as evident in BMRs were
presented and cross verified from QC-Test Reports.
12. Do you have documents confirming the The firm has imported all the excipients vide proper
import of the used excipients? import documents.
protocols for the development of Esonap development of Esonap 500/20mg tablets (Naproxen and
tablets? Esomeprazole).
15. Have you performed Drug-excipients The firm has not performed Drug-excipients
compatibility studies? compatibility studies as their formulation (API &
pharmaceutical grade Ecipients) is similar to that of the
Vimovo 500/20mg Tablets Manufactured By Astra
Zeneca USA.
dissolution studies? with innovator product Vimovo tablets manufactured by
Astra zenica USA. The dissolution test was carried out
on 6 basket dissolution apparatus while analytical tests
were carried out using 21 CFR II compliant HPLC and
results are comparable. The HPLC used for the stability
studies upto 06 months studies on software which is not
21CFR II compliant, however the record from logbooks,
analytical test reports was verifiable onsite. Whereas, the
rest of 12 and 18 months studies testing was carried out
on 21 CFR II compliant HPLC. A complete trail of such
testing was available and verifiable.
QC lab.
for development of Esonap tablets? manufacturing of trial batches has been carried out in
qualified equipments used for commercial production
and the analytical part has been performed via dedicated
& calibrated equipments in quality control laboratory.
calibration / re-qualification program for qualification program for the equipment used in
the equipment used in PD section? production and QC of trial batches of Sachet dosage form
which was found implemented.
development?
batches for the stability studies of Esonap stability studies of Esonap 500/20mg tablets bearing
tablets as required? batch numbers NPD610(T-01), NPD610(T-02) and
NPD610(T-03) with batch size of 6384, 6692 and 6748
tablets, respectively.
23. Do you have any criteria for fixing the As per statement of the firm the criteria for fixing the
batch size of stability batches? batch size of stability batches is the number of sachets
per testing frequency and number of testing frequencies
while keeping in view the decision of Registration Board
(RB) in its 249th Meeting.
of stability batches? batches. Necessary log books of equipment used has
been available with the firm, assuring the traceability of
product (Tablets).The method is gradient mode and
27. Do you have method transfer studies in The firm has not conducted method transfer studies,
qualification of equipments / instruments equipment / instruments being used in the test and
being used in the test and analysis of analysis of Naproxen and Esomeprazole APIs and the
Naproxen and Esomeprazole APIs and the finished drug Esonap 500/20mg tablets.
finished drug (Esonap tablets)?
30. Do your HPLC software is 21CFR Firm has 03 HPLCs out of which one is dedicated for
compliant? R&D testing and is 21 CFR II. This HPLC system was
used for stability studies of Esonap tablets. The HPLC
used for the stability studies upto 06 months studies has
software not 21CFR compliant, however the record from
Whereas, the 12 and 18 months studies/ testing is carried
out on 21 CFR II compliant. Moreover, the comparative
dissolution studies and dissolution profile as per USFDA,
and impurity study has also been tested using 21 CFR II.
A complete trail of such testing is available and
verifiable.
31. Can you show Audit Trail reports on Audit trail on the testing (21 CFR II) reports can be
Esonap testing? made from 12 and 18 months studies. Also for
Dissolution Profile as per USFDA specifications, and for
Comparative Dissolution Studies as well.
degradation products and stability batches? however, there is no quantities of degradation products.
stability testing? on the three stability batches of Esonap 500/20mg
tablets. Also the firm has completed the real time
stability testing upto 18 months time points on all three
batches with satisfactory results.
equipment‘s used in Esonap 500/20mg used in Esonap 500/20mg tablets production and
tablets production in analysis? analysis.
control are available for stability chamber? from generator are available for stability chamber. That
is in case of load shedding start up time of the generator
is within 02 minutes as demonstrated during the onsite
inspection.
personnel and utilities be rated as GMP and utilities are rated as GMP compliant.
compliant?

1. On the basis of risk based approach the genuineness / authenticity of stability data submitted by
the firm for registration of Esonap 500/20mg Tablets (Naproxen and Esomeprazole) is verifiable
to satisfactory level.
2. The related manufacturing area, equipments, personnel and utilities are GMP compliant and well
suited for the manufacturing of Esonap 500/20mg Tablets, therefore, the panel recommends the
registration of Esonap 50/20mg tablets in the name of the manufacturer.
3. The comparative dissolution studies have been conducted by the firm on Esonap 500/20mg
tablets with the brand Vimovo 500/20mg tablets manufactured by M/s Astra Zeneca USA.
The Dissolution Profile has been carried out by the firm using 21 CFR II 09, 12 and 18 months studies
testing was carried out as 21 CFR II compliant. A complete trail of such testing was available
and verifiable. The HPLC used for the stability studies upto 06 months studies on software
which is not 21CFR II compliant, however the record from logbooks, analytical test reports was
verifiable onsite.
Decision:Registration Board decided to approve registration of “Esonap 500/20mg Tablets (Naproxen and
Esomeprazole) by M/s. Vision Pharmaceuticals (Pvt.) Ltd., Plot No. 22 - 23, Industrial Estate, Kahuta road,
Model Town, Islamabad. Manufacturer will place first three production batches on long term stability studies
throughout proposed shelf life and on accelerated studies for six months.
Sr. Name & Address Brand Name Type of Form, International Previous DRB
No. of Manufacturer / (Proprietary Name Initial Diary & Availability / Decision /
Applicant + Dosage Form + Date, Fee Local Remarks
Pharmacological Demanded Price / GMP Inspection
Group, Pack size Report Date &
Finished Product Remarks
Specification
87. M/s Genix Pharma Lanzole-D Capsule Form 5 USFDA The firm has
Dairy No. 6 dated Manufacturer‘s
Each capsule 1-3-2011 Last inspection Specifications.
contains: report 8-8-2017
Rs.8,000/- dated 1- firm was
Dexlansoprazole 3-2011.(Duplicate) considered to be
enteric coated pellets operating at
eq to Rs.12,000/ dated satisfactory level
Dexlansoprazole…… 19-3- of compliance
..30mg 2015(Duplicate) with cGMP
guidelines at the
(Anti-Ulcerative) Rs.80,000, dated time of inspection.
11-3- It is suggested that
2017(Duplicate) management
should purchase
14‘s Rs1260/-, Liquid particle
30‘s Rs 2700/- counter for QC lab
on immediate
basis.
Drug Lanzole-D Capsule 30mg
Name of Manufacturer M/s Genix Pharma, Karachi
Manufacturer of API M/s Alphamed Formulations Pvt Limited, India
Description of Pack Alu/Alu Blister foil
Time Period Accelerated: 26weeks Real Time: 06 Months
Frequency Accelerated: Weeks(0,1,2,3,4,6,8,12,16,20,24,26)
Real Time: 0,1,2,3,4,6 (Month)
Batch No. TR001 TR001 TR001
Batch Size 800 Capsules 800 Capsules 800 Capsules
Date of Initiation 04-2017 04-2017 04-2017
No. of Batches 03
COA shows that Dissolution testing of pellets are done at
pH 6, and pH7.4.
manufacturer issued by regulatory authority Administration, Govt. of telangana is submitted. It is valid
of country of origin. up to 13-12-2018
sheets etc.
5. Documents confirming import of API etc. Copy of DHL invoice is attached. API Purchased From:
Alphamed Formulations Pvt Ltd India.
To: M/S Morgan Chemicals, Karachi
Rules, 1978.
● The firm has provided 26weeks Accelerated and 06 Months Real Time Stability Data for 03 Batches.
Sr. Name & Address Brand Name Type of Form, International Previous DRB
No. of Manufacturer / (Proprietary Name Initial Diary & Availability / Decision /
Applicant + Dosage Form + Date, Fee Local Remarks
Pharmacological Demanded Price / GMP Inspection
Group, Pack size Report Date &
Finished Product Remarks
Specification
88. M/s Genix Pharma Lanzole-D Capsule Form 5 USFDA The firm has
Each capsule dated 5-03-2011 Last inspection Specifications.
contains: report 8-8-2017
Rs.8,000/- dated 5- firm was
Dexlansoprazole 3-2011.(Duplicate) considered to be
enteric coated pellets operating at
eq to Rs.12,000/ dated satisfactory level
Dexlansoprazole…… 19-3- of compliance
..60mg 2015(Duplicate) with cGMP
guidelines at the
(Anti-Ulcerative) Rs.80,000, dated time of inspection.
11-3-2017 It is suggested that
management
14‘s Rs2500/-, should purchase
30‘s Rs 5350/- Liquid particle
counter for QC lab
on immediate
basis.
Drug Lanzole-D Capsule 60mg
Name of Manufacturer M/s Genix Pharma, Karachi
Manufacturer of API M/s Alphamed Formulations Pvt Limited, India
Description of Pack Alu/Alu Blister foil
Time Period Accelerated: 26weeks Real Time: 06 Months
Frequency Accelerated: Weeks(0,1,2,3,4,6,8,12,16,20,24,26)
Real Time: 0,1,2,3,4,6 (Month)
Batch No. TR001 TR002 TR003
Batch Size 800 Capsules 800 Capsules 800 Capsules
Date of Initiation 04-2017 04-2017 04-2017
No. of Batches 03
COA shows that Dissolution testing of pellets are done at
pH 6, and pH7.4.
manufacturer issued by regulatory authority Administration, Govt. of telangana is submitted. It is valid
of country of origin. up to 13-12-2018
sheets etc.
5. Documents confirming import of API etc. Copy of DHL invoice is attached. API Purchased From:
Alphamed Formulations Pvt Ltd India.
To: M/S Morgan Chemicals, Karachi
Rules, 1978.
● The firm has provided 26weeks Accelerated and 06 Months Real Time Stability Data for 03 Batches.
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Lanzole-D
(Dexlansoprazole) 30mg & 60mg Capsules
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Lanzole-D
(Dexlansoprazole) 30mg & 60mg Capsules by M/s Genix Pharmaceuticals Pvt. Limited, Karachi.
Reference No: F.13-11/2017-PEC dated 3rd April, 2018.

Investigation Date and Time: 9th April, 2018. (Forernoon)
Investigation Site: Factory premises of Genix Pharmaceuticals Pvt. Ltd. Karachi.
Background:
Chairman Registration Board considered the applications of M/s. Genix Pharmaceuticals (Pvt.) Ltd.,
Karachi for registration of Lanzole-D (Dexlansoprazole) 30mg & 60mg Capsules and constituted a three
member panel to investigate the authenticity / genuineness of data (import of raw material and stability data).
Panel was advised to conduct inspection of the firm and to submit report for further consideration.
1. Dr. Rafeeq Alam, Meritorious Professor and Chairman Department of Pharmacology, University of
Karachi, Karachi.
2. Dr. Syed Muzafar Ali Jafri, Director, DTL Sindh, Karachi.

involved, ongoing studies, printed data and integrity and security of data in respective databases were also
audited. The details of investigation may be summarized as under:
Details of Inspection
S.No. Description Observation by panel

The firm has procured 1.0 Kg Dexlansoprazole pellets
through Morgan Chemicals agent of Alphamed
Do you have documents confirming Formulations Private Ltd. by DHL dated 11-02-2017.
1 the import of API including approval That‘s why no approval was obtained from DRAP.
from DRAP? Batch No. Quantity Imported
BVA16001 1.0 Kg
There is proper vendor evaluation process being
implemented by the firm and the rationale behind vendor
Do you have any rationale behind
2 selection is controlled through:
selecting the particular manufacturer
The firm has procured 4.0gm working standard through
Do you have documents confirming
Morgan Chemicals agent of Alphamed Formulations
3 the Import of Reference standard and
Private Ltd.
Impurities standards?
4 The firm has Certificate of Analysis for API and working
Do you have certificate of analysis of
standards.
the API reference standard and
Do you have any approval of API or The firm has provided copy of GMP certificate issued by
GMP certificate of manufacturer Drug Control Administration Govt. of Telangana having
5
issued by regulatory authority of product list containing Dexlansoprazole Raw Material.
country of origin?
Do you use API manufacturer method The firm has used API Manufacturer‘s method of testing
6
of Testing for testing of API?
Do you have stability Studies Report The firm has stability studies report of API
7
on API? Dexlansoprazole conducted by API manufacturer.
If Yes, whether the stability testing The manufacturer of API has performed the stability
has been performed as per SIM studies of API as per SIM Method and the Related
8
method and degradation products have Substance have been quantified by the API manufacturer
been quantified.?
Do you have method for quantifying The firm has methods for quantifying the impurities in API.
9
the impurities in the API?
Do you have some remaining The firm has no remaining quantity API Dexlansoprazole
10 quantities of the API, Its reference but having some remaining quantities of working standard
standard and impurities standard?
Have you used pharmaceutical grade Empty Shell size no 3 for 30mg.
11 Empty Shell size no 2 for 60mg
excipients?
Do you have documents confirming Empty Shell has been imported from Qualicap, Japan.
12
the import of the used excipients
Do you have test reports and other The firm has test reports on empty shell size no 3 and 2.
13
records on the excipients?
Do you have written and authorized The firm has written and authorized protocol for the
14 protocols for the development of development of Lanzole-D Capsuless 30mg/60mg
Lanzole-D Capsules 30mg/60mg
Have you performed Drug-Excipient Not Applicable
15
Firm has performed comparative studies with innovator
Have you performed comparative
DEXILANT CAPSULES 30mg/60mg manufactured by
16 studies?
Takeda Pharmaceutical company 17-85 Jusohomarchi, 2-
chome Osaka 532-8686, Japan.
Do you have Product Development / The firm has product development (R&D) Section with the
17 R&D Section? facility of manufacturing only whereas analysis part was
performed in routine Analytical Laboratory
Do you have necessary equipment‘s The firm has necessary equipment available in product
available in product development development section for development of Lanzole-D
18
section for development of Lanzole-D Capsules 30mg/60mg.
Capsules 30mg/60mg?
Are the equipment‘s in product The available equipment in Product Development are
19 qualified.
development qualified?
Do you have proper maintenance / There is proper maintenance / calibration program for the
20 calibration / re-qualification program equipment used in PD
for the equipment used in PD?
Do you have qualified staff in product The firm has proper qualified staff for Product
development section with proper Development.
21
knowledge and training in product 08 Pharmacists and 03 Chemists.
development?
Have you manufactured three stability The firm has manufactured three stability batches each of
batches for the stability studies of 800 capsules.
Lanzole-D Capsules 30mg/60mg as Lanzole-D Capsules 30mg
required? Batch No Date of Mfg. Expiry Date
22
Batch No.TR001 APR-2017 APR-2019
Lanzole-D Capsules 60mg
Batch No Date of Mfg. Expiry Date
Do you have any criteria for fixing the The criteria for fixing the batch size of stability batches is
23
batch size of stability of batches? the number of samples required per testing frequencies.
Do you have complete record of The firm has detailed record of the stability batches of
24 Lanzole-D Capsules 30mg/60mg.
production of stability batches?
Do you have protocols for stability The firm has protocols for testing of stability batches.
25
testing of stability batches
Do you have developed and validated The firm has developed and validated method of testing of
26 the method for testing of stability finish product Lanzole-D Capsules 30mg/60mg, based on
batches method of testing of API.
Do you have method transfer studies Method transfer studies is not applicable as the firm
in case when the method of testing developed their own method and validated.
27
being used by your firm is by any
other lab.
Do you have documents confirming the The firm has proper documents confirming the qualification of
qualification of equipment / instruments equipment / instruments being used in the test and analysis of the
28 being used in the test and analysis of the Lanzole-D Capsules 30mg/60mg
product‘s API and product Lanzole-D
Capsules 30mg/60mg?
Do your method of analysis Stability The firm has performed force degradation study on their product
29 indicating? for conformance of its stability indicating method.
Do your HPLC software 21CFR The HPLC software is 21CFR compliant and having certificates
30 compliant? of Compliance by USFDA
Can you show audit trail reports on The firm has audit trail Reports on their testing.
31 Lanzole-D Capsules testing?
Do you have some remaining The firm has some remaining quantities of stability batches.
32 quantities of degradation products and However, for unknown impurities chromatographic method
stability batches? has been used.
The firm has three stability batches kept on stability for

Do you have batches kept on stability
33 Real time stability testing. 8 Months Real Time and 6
testing?
months Accelerated stability studies has been conducted.
Do you have valid calibration status The firm has valid calibration status for the equipment used
for the equipment‘s used in Lanzole-D in Lanzole-D Capsules 30mg/60mg production and
34
Capsules 30mg/60mg production and analysis.
analysis?
Do Proper and Continuous monitoring Adequate monitoring and control are available for stability
35 and control are available for stability chamber. Chambers are controlled and monitored through
chamber? software 21CFR compliance.
Do related manufacturing area, Related manufacturing area, equipment, personnel and
36 equipment, personnel and utilities be utilities can be rated as compliant to minimum standards of
rated as GMP compliant? GMP.
Any specific observation / The firm has conducted dissolution testing on the pellets at
recommendation by the registration pH 5.5 & 7.0. The results of dissolution testing are well in
board: acceptance to the requirements of the innovator & the FDA.
The firm must submit their own
37
analysis record of dissolution testing
on pellets confirming their dual
delayed release profile at pH 5.5 and
6.75/7.0.
Conclusions:
1. On the basis of risk-based approach the genuineness / authenticity of stability data submitted by the
firm for registration of Lanzole-D 30mg and 60mg Capsule (Dexlansoprazole) is verifiable to highly
satisfactory level.
2. The related manufacturing area, equipments, personnel and utilities are compliant to minimum
standards of GMP and are suited for the manufacturing of Lanzole-D 30mg and 60mg Capsules.
Decision: Registration Board decided to approve registration of “Lanzole-D 30mg and 60mg Capsule
(Dexlansoprazole) by M/s Genix Pharmaceuticals Pvt. Limited, Karachi.. Manufacturer will place first
three production batches on long term stability studies throughout proposed shelf life and on accelerated
Evaluator PEC-VIII
89. Name and address of manufacturer / M/s Hudson Pharma (Pvt.) Ltd. D-93, North Western
Brand Name +Dosage Form + Strength Bufen Injection 100mg
Composition Each PE ampoule contains:
Ibuprofen…400mg
Diary No. Date of R& I & fee Dy. No. 1580; 08-08-2016; Rs. 50,000/-, 03-08-2016
Pack size & Demanded Price As per SRO.
Approval status of product in Reference Approved in TGA, Australia
form)
GMP status GMP inspection conducted on 11-12-2017 shows that
firm is operating at acceptable level of GMP
compliance.
Drug Bufen injection 100mg (Ibuprofen 400mg/4ml)
Name of Manufacturer M/s Hudson Pharma (Pvt.) Ltd. D-93, North Western Industrial Zone, Port
Qasim, Karachi
Manufacturer of API Hubei Granules Biocause Pharmaceutical Company
API Lot No. C100-1703198M
Description of Pack
PE ampoules
Time Period Real Time: 06 Months Accelerated: 06 Months
Frequency Real Time: 0,1,3,6 Months(on going)
Accelerated: 0,1,3,6 Months
Batch No. 001 002 003
Batch Size 20 litter 20 litter 20 litter
(5,000ampoules) (5,000ampoules) (5,000ampoules)
Date of Initiation 03/04/2017 23/05/2017 01/07/2017
No. of Batches 03
No.
1. COA of API Yes
2. Approval of API by regulatory authority of Copy of GMP certificate issued by China Food and Drug
country of origin or GMP certificate of API Administration valid till 28/08/2022.
manufacturer issued by regulatory authority
sheets etc.
Rules, 1978.
● Clarification is required since the commercial invoice of API attached with the dossier shows that raw
material is imported in Pakistan on 13-06-2017 while the manufacturing dates of the first two trial
batches (27-03-2017), (18-05-2017), are prior to the date of approval for import of said batch of API.
(13-06-2017).
i. In response to this query firm has submitted another commercial invoice of Batch No.: C100-
1701199M dated 17-02-2017 (05Kg) but it was not evident from submitted data that this API
lot is used in manufacturing of trial batches as in submitted data it was mentioned that Batch
No.: C100-1703198M dated 13-06-2017 (25Kg) is used in manufacturing of trail batches &
remaining quantity of API is 18 Kg when firm was again asked for clarification than they
submitted that first two trial batches were prepared from this lot of API (Batch No.: C100-
1701199M dated 17-02-2017) (05Kg)
● Submit raw data sheets of analytical method of submitted stability studies.
● Evidence of applied formulation is packed in PE ampoules in reference agencies.
ii. Applied formulation is not found in PE ampoules in reference agencies and representative of
firm also inform that it is not present in any reference agency in this packaging material and
submitted stability studies are not extensive enough to demonstrate that this packing material
does not influence product in any way.
Evaluation by PEC:
Now the firm has submitted data as per checklist approved in 276 th meeting of Registration Board for
exemption from ―On site investigation of submitted stability data‖. Details of submitted data are as
under:
(Dy.# 3316 dated 25-01--2018)
1. Reference of last onsite panel inspection Firm has referred to onsite inspection report of their
for instant dosage form conducted during product ―Easehale + Respules 0.5mg/2.5mg PE Ampoules
last two years. / 2.5ml (Ipratropium Bromide…0.5mg, Salbutamol
Sulfate…3mg equivalent to Salbutamol base 2.5 mg)
Injection‖, which was conducted on 11th October, 2017
and was presented in 275th meeting of Registration board
held on 25-27th October, 2017. Registration Board
decided to approve registration of Easehale + Respules
0.5mg/2.5mg PE Ampoules / 2.5ml by M/s. Hudson
Pharma.
2. Documents for the procurement of API Firm has submitted copy of commercial invoice for
with approval from DRAP (in case of Ibuprofen, attested by AD (I&E), DRAP Karachi detailed
import). as under:
Batch No.: C100-1703198M dated 13-06-2017 (25Kg)
Batch No.: C100-1701199M dated 17-02-2017 (05Kg)
● It is to be noted that submitted documents of
product development initially mention use of only
one batch no. of API i.e. C100-1703198M while the
manufacturing dates of the first two trial batches
(27-03-2017), (18-05-2017), are prior to the date of
approval for import of said batch of API. (13-6-
2017)
3. Documents for the procurement of Firm has only submitted COA of Working standard.
reference standard and impurity standards. They have not submitted the commercial invoice
confirming procurement of reference standard and
impurity standards.
4. Approval of API/ DML/GMP certificate Firm has submitted following:
of API manufacturer issued by regulatory i. Copy of GMP certificate issued to Hubei Granules
authority of country of origin. Biocause Pharmaceutical Company by China
Food & Drug Administration, valid upto 28-08-
2022.
5. Mechanism for Vendor pre-qualification. Firm has submitted following:
i. SOP for Vendor Evaluation
6. Certificate of analysis of the API, Firm has submitted following:
reference standards and impurity i. COA of API, Ibuprofen (75 Grade) (Batch.#
standards. C100-1703198M) from M/s Hubei Granules
Biocause Pharmaceutical Company.
ii. COA of API with batch no., C100-1701199M has
not been submitted.
iii. COA of working standard has been submitted.
iv. COA of Impurity standard has not been
submitted.
7. Documents for the procurement of Not Submitted.
excipients used in product development?
8. List of qualified staff involved in product One technical person with five years‘ experience is
development with relevant experience. currently working in R & D dept. of firm.
Production Data
9. Authorized Protocols/SOP for the Firm has submitted following:
development & stability testing of trial i. Copy of SOP for Ibuson Injection 400mg
batches. Development effective from 28-10-2016.
ii. Stability study protocol for Ibuson Injection
400mg effective from 23-02-2017.
10. Complete batch manufacturing record of Firm has Batch Manufacturing Record, including,
three stability batches. Dispensing sheets, & Standard Manufacturing procedure,
for all the three batches of Bufen 400mg/4ml injection of
following three trail batches 001, 002, 003.
11. Record of remaining quantities of stability Firm has submitted reconciliation sheet for use of
batches. ibuprofen 400mg/4ml for all the three stability batches.
Batch Batch Ampoule Kept on Remaining
No. size Produce stability
001 5000 2510 1400 1110
002 5000 2595 1400 1195
003 5000 2735 1400 1335
QA/QC DATA
12. Record of Digital data logger for
temperature and humidity monitoring of Yes
stability chambers (real time and
accelerated)
13. Method used for analysis of API along Firm has submitted Method of analysis & COA for
with COA. Ibuprofen from M/s Hubei Granules Biocause
Pharmaceutical Company.
14. Method used for analysis of FPP & Firm has submitted following for both accelerated & real
complete record of testing of stability time stability studies of all three stability batches:
batches (i.e. chromatograms, lab reports, i. Method of analysis.
raw data sheets etc.) In Method of analysis of ibuprofen 400mg/4ml
injection wavelength of detector was 254 nm
but on chromatograms wavelength of detector
was 214nm than upon clarification firm has
submitted revised Method of analysis of
ibuprofen 400mg/4ml injection.
ii. Lab reports
iii. Raw data sheets
iv. HPLC Chromatograms (for Assay analysis)
15. Reports of stability studies of API from Yes
manufacturer.
16. Analysis reports for excipients used. Instead of analysis reports for excipient used, Firm has
submitted method of analysis of excipients.
17. Drug-excipients compatibility studies. Not submitted
18. Record of comparative dissolution data. Not applicable
19. Compliance Record of HPLC software Firm has submitted audit trail reports for HPLC analysis
21CFR & audit trail reports on product of both stability studies.
testing. ● The firm has submitted the photocopy of audit
trial for testing of ibuprofen injection,
according to the trial the analysis was carried
on January 2018 whereas the submitted
stability studies are otherwise, than upon query
data of year 2017 was provided by the firm.
Decision: Registration Board decided to constitute panel for onsite investigation to confirm
genuineness / authenticity of stability data and associated documents, import of API, quality,
specification, test analysis, facilities etc.
Evaluator PEC-II
No. Manufacturer / (Proprietary Name Initial Diary & Date, Availability / Local
Applicant + Dosage Form + Fee (including Availability
Strength), differential fee),
Composition, Demanded Price / Pack GMP Inspection
Pharmacological size Report Date &
Group, Remarks
Finished Product
Specification
1. M/s Wilson SOFVASC FORTE Form 5D The product is approved
Pharmaceuticals, I-9 film Dy. No. 353 in
Industrial Area, coated tablets 5/50 Dated 11/12/2010 Hungary, Romania,
Islamabad Each Film Coated Rs. (15,000/-) Slovania and Czech
Tablet contains: Dated (11/12/2010) + Republic.
Amlodipine as (35,000/- Dated N/A
Camsylate….5mg (17/01/2017) Last routine GMP
Losartan Pack size inspection was
potassium…. 50mg 10‘s & 20‘s conducted on 24-1-2018
Antihypertensive Price and the report concludes
65/- per tablet a very good level of
GMP compliance.
Background:
The case was initially presented in 268th meeting along with stability study data wherein the case was
deferred for several reasons. The case was again discussed in 270th meeting wherein Mr. Tipu Sultan
Akram, GM of the firm appeared before the Registration Board for clarifying the queries raised on
previous stability studies as formulation has been changed. The representative apprised the Board
that they had conducted new stability studies of the product after change in formulation and the data
will be submitted for evaluation and approval.
Subsequently in 271st meeting of Registration Board the new stability studies of the product after
change in formulation was discussed and was deferred for clarifications
of following points:
Use of expired API (Losartan potassium) in the manufacturing of finished drugs.
Documents confirming import of API for Amlodipine camsylate and Losartan potassium which
was used in the manufacturing of 1,29,000/- tablets.
Significant changes seen in above mentioned 01 batch showing more than 5% difference in assay
value from its initial value in long-term stability studies.
Evaluation by PEC:
Now the Firm has submitted third stability study data for evaluation with following statements:
―It is submitted that the data considered in 271st meeting of the Drug Registration Board may please
be considered as withdrawn and afresh data submitted herewith be considered for drug registration.‖
Firm has submitted revised master formulation, manufacturing method & finished product testing
method.
The details of new stability study data are as under:
Drug Sofvasc Forte 5/50 mg
Name of Manufacturer M/s Wilson Pharmaceuticals, I-9 Industrial Area, Islamabad
Manufacturer of API Losartan Potassium: M/s Zhejiang Tianyu Pharmaceutical Co., Ltd.
China
Amlodipine Camsylate: M/s Ami Life Sciences Pvt. Ltd. India
API Lot No. Losartan Potassium: 10100-160308
Amlodipine Camsylate: AMC021101
Description of Pack
Alu/PVC blister strip
Batch No. Trial# 01 Trial# 02 Trial# 03
No. of Batches 03
No.
1. COA of API. Yes
2. Approval of API by regulatory authority of Losartan Potassium: Copy of GMP certificate
country of origin or GMP certificate of API (Certificate No. 1704054) for M/s Zhejiang
manufacturer issued by regulatory authority of Tianyu Pharmaceutical Co., Ltd. China issued
country of origin. by State Food & Drug Administration, valid upto
26-04-2019.
Amlodipine Camsylate: Copy of GMP
certificate (Certificate No. ZJ20130111) for M/s
Ami Life Sciences Pvt. Ltd. India issued by
Food & Drug Control Administration Gujarat, valid
upto 09-12-2018.
Yes
5. Documents confirming import of API etc. Losartan Potassium: Copy of commercial
invoice has been submitted. The said invoice is
attested by ADC, DRAP Islamabad.
Amlodipine Camsylate: Copy of commercial
not attested by ADC, DRAP.
sign and stamp) for ensuring authenticity of Yes
data / documents.
Yes
Rules, 1978. Yes
 Commercial invoice of Amlodipine camsylate has not been attested by DRAP. Firm has submitted copy
of airway bill.
The firm has requested for Exemption from On-site Investigation of their submitted stability data vide
Letter no. WIP/RGA-001/04/18, dated 05-04-2018 and provided the following documents in conjunction
Date of submission: 06-04-2018 vide diary no. 397 (PEC)
1. Reference of last onsite panel inspection Registration Board decided to approve Registration of
for instant dosage form conducted during “Saferon (Sofosbuvir 400mg) tablets by M/s Wilson
last two years. Pharmaceuticals, I-9 Industrial Area, Islamabad in its
278th Meeting.
Date of Inspection: 10-12-2015 , 19-04-2017 & 20-01-

2018
 Software of HPLC present in the firm is 21CFR
compliant and audit trail on the testing reports was
available and confirmed.
2. Documents for the procurement of API Losartan Potassium: Copy of commercial invoice has
with approval from DRAP (in case of been submitted. The said invoice is attested by ADC,
import). DRAP Islamabad.
Amlodipine Camsylate: Copy of commercial invoice has
been submitted. The said invoice is not attested by ADC,
DRAP. Copy of airway bill has been submitted.
3. Documents for the procurement of Losartan Potassium:
reference standard and impurity  Copy of COA of reference standard has been
standards. submitted
 No invoice has been submitted as evidence for the
procurement of reference standard and impurity
standards
Amlodipine Camsylate:
 Copy of COA of reference standard has been
submitted
standards
4. Approval of API/ DML/GMP certificate Losartan Potassium: Copy of GMP certificate
of API manufacturer issued by regulatory (Certificate No. 1704054) for M/s Zhejiang Tianyu
authority of country of origin. Pharmaceutical Co., Ltd. China issued by State Food &
Amlodipine Camsylate: Copy of GMP certificate
(Certificate No. ZJ20130111) for M/s Ami Life Sciences
Pvt. Ltd. India issued by Food & Drug Control
Administration Gujarat, valid upto 09-12-2018.
5. Mechanism for Vendor pre-qualification The firm has submitted photocopy of ‗Work instructions
for Evaluation of Vendors and Suppliers‘.
6. Certificate of analysis of the API, Losartan Potassium:
reference standards and impurity  Copy of COA of API (Batch #. 10100-160308) from
standards M/s Zhejiang Tianyu Pharmaceutical Co., Ltd. China
has been submitted

Copy of COA of reference standard has been
submitted
 COA of any impurity standard has not been
submitted
 Copy of COA of API (Batch #. AMC021101) from
M/s Ami Life Sciences Pvt. Ltd. India has been
submitted
submitted
submitted
7. Documents for the procurement of The firm has submitted photocopy of Commercial
excipients used in product development? invoices/COAs of all the excipients used in the
formulation of applied product
8. List of qualified staff involved in product The firm has submitted photocopy of List of qualified staff
development with relevant experience. involved in product development section comprising of 9
persons.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted photocopy of ― Protocols/SOP for
development & stability testing of trial the Development of Sofvasc Forte tablets 5/50mg‖.
batches.
three stability batches. Manufacturing Record and Batch Packaging Record of the
following 03 Batches:
Trial# 01 1500 Tablets 02-2017
Trial# 03 1500 Tablets 02 -2017
11. Record of remaining quantities of Trial Number Total Packs Remaining
stability batches. No of tablets Packs used for Packs
analysis
Trial# 1386 138 20 118
01
Trial# 1386 138 16 122
02
Trial# 1386 138 16 122
03
QA / QC DATA
12. Record of Digital data logger for Firm has submitted photocopies of data logger record for
temperature and humidity monitoring of Accelerated stability chamber from 01-01-2017 to 12-02-
stability chambers (real time and 2018 and for Real Time stability chamber starting from 01-
accelerated) 01-2017 to 05-03-2018
13. Method used for analysis of API along The firm has submitted photocopy of Raw Material
with COA. Specifications, Raw Material Testing Procedures along
with COAs for Amlodipine camsylate & Losartan
potassium.
14. Method used for analysis of FPP & The firm has submitted photocopy of Finished Product
complete record of testing of stability Testing Procedure for Sofvasc forte 5/50 mg Tablet along
batches (i.e. chromatograms, lab reports, with Stability Study Reports.
raw data sheets etc.)  Raw data sheets for stability studies data has not been
submitted.
 Firm has submitted analytical record for system
suitability test wherein the RSD calculated for
injection precision of peak area for both
Amlodipine camsylate & Losartan potassium is less
than 2% wherein in routine analysis firm has
recorded only one injection of Standard solution
for both Assay test and Dissolution test.
15. Reports of stability studies of API from Losartan potassium: The firm has submitted photocopy
manufacturer. of 06 Months Accelerated and 24 Months Real Time
Stability Study Data of 03 Batches from M/s Zhejiang
Tianyu Pharmaceutical Co., Ltd. China
Amlodipine camsylate: The firm has submitted
photocopy of 06 Months Accelerated and 12 Months Real
Time Stability Study Data of 03 Batches from M/s Ami
Life Sciences Pvt. Ltd. India.
16. Analysis reports for excipients used. The firm has submitted photocopy of Analytical reports of
their own for excipients used.
17. Drug-excipients compatibility studies.  The firm has not performed Drug-excipients
compatibility studies and has referred to monographs
from Handbook of Pharmaceutical Excipients, Tests &
Trials and Stability Studies conducted by Wilson‘s
Pharmaceuticals.
18. Record of comparative dissolution data.  Firm has submitted Comparative dissolution study of
their product with Cozaar XQ tablets 5/50mg.
Feature Reference Product of M/s
Product Wilsons
Pharma.
Brand name Cozaar XQ Sofvasc Forte
tablets 5/50mg. 5/50mg
Batch No. NO13813 Trial#. 01
Mfg. date 01-2017 02-2017

Comparative dissolution study was performed in
following media:
i. 0.1N HCl
ii. Acetate Buffer.
iii. Phosphate Buffer
The results submitted by firm show comparable
dissolution profile of reference and applied product.
 Firm has submitted chromatograms of Comparative
Dissolution study.
19. Compliance Record of HPLC software The firm has submitted following:
21CFR & audit trail reports on product  Copy of calibration certificate for HPLC system form
testing. ―Technology Links (Pvt.) Ltd.
 Copy of Audit trail record from January 2017 to
November 2017
Decision: Registration Board decided to approve registration of “Sofvasc Forte film coated tablets
5/50 (Amlodipine as camsylate/Losartan potassium) by M/s Wilson Pharmaceuticals, I-9 Industrial
Area, Islamabad. Manufacturer will place first three production batches on long term stability
studies throughout proposed shelf life and on accelerated studies for six months.
Sr. Name & Address of Brand Name Type of Form, International Availability
No. Manufacturer / Applicant (Proprietary Name + Initial Diary & Date, Fee / Local Availability
Dosage Form + (including differential
Strength), fee), GMP Inspection Report
Composition, Demanded Price / Pack Date & Remarks
Pharmacological size
Group,
Finished Product
Specification
2. M/s Wilson SOFVASC FORTE Form 5D The product is approved
Pharmaceuticals, I-9 film Dy. No. 352 in
Industrial Area, coated tablets 5/100 Dated 11/12/2010 Hungary, Romania,
Islamabad Each Film Coated Rs. (15,000/-) Slovania and Czech
Tablet contains: Dated (11/12/2010) + Republic.
Amlodipine as (35,000/- Dated N/A
Camsylate….5mg (17/01/2017) Last routine GMP
Losartan Pack size inspection was
potassium…. 10‘s & 20‘s conducted on 24-01-
100mg Price 2018 and the report
Antihypertensive 65/- per tablet concludes a very good
level of GMP
compliance.
Background:
The case was initially presented in 268th meeting along with stability study data wherein the case was
deferred for several reasons. The case was again discussed in 270th meeting wherein Mr. Tipu Sultan
Akram, GM of the firm appeared before the Registration Board for clarifying the queries raised on
previous stability studies as formulation has been changed. The representative apprised the Board
that they had conducted new stability studies of the product after change in formulation and the data
will be submitted for evaluation and approval.
Subsequently in 271st meeting of Registration Board the new stability studies of the product after
change in formulation was discussed and was deferred for clarifications
of following points:
Use of expired API (Losartan potassium) in the manufacturing of finished drugs.
Documents confirming import of API for Amlodipine camsylate and Losartan potassium which
was used in the manufacturing of 1,29,000/- tablets.
Significant changes seen in above mentioned 01 batch showing more than 5% difference in assay
value from its initial value in long-term stability studies.
Evaluation by PEC:
Now the Firm has submitted third stability study data for evaluation with following statements:
―It is submitted that the data considered in 271st meeting of the Drug Registration Board may please
be considered as withdrawn and afresh data submitted herewith be considered for drug registration.‖
Firm has submitted revised master formulation, manufacturing method & finished product testing
method.
The details of new stability study data are as under:
Drug Sofvasc Forte 5/100 mg
Name of Manufacturer M/s Wilson Pharmaceuticals, I-9 Industrial Area, Islamabad
Manufacturer of API Losartan Potassium: M/s Zhejiang Tianyu Pharmaceutical Co., Ltd.
China
Amlodipine Camsylate: M/s Ami Life Sciences Pvt. Ltd. India
API Lot No. Losartan Potassium: 10100-160308
Amlodipine Camsylate: AMC021101
Description of Pack
Alu/PVC blister strip
Batch No. Trial# 01 Batch No. Trial# 01
Batch Size 1500 tablets Batch Size 1500 tablets
Manufacturing Date 02-2017 Manufacturing Date 02-2017
Date of Initiation 15-02-2017 Date of Initiation 15-02-2017
No. of Batches 03
No.
1. COA of API. Yes
2. Approval of API by regulatory authority of Losartan Potassium: Copy of GMP certificate
country of origin or GMP certificate of API (Certificate No. 1704054) for M/s Zhejiang
manufacturer issued by regulatory authority of Tianyu Pharmaceutical Co., Ltd. China issued
country of origin. by State Food & Drug Administration, valid upto
26-04-2019.
Amlodipine Camsylate: Copy of GMP
certificate (Certificate No. ZJ20130111) for M/s
Ami Life Sciences Pvt. Ltd. India issued by
Food & Drug Control Administration Gujarat, valid
upto 09-12-2018.
Yes
5. Documents confirming import of API etc. Losartan Potassium: Copy of commercial
attested by ADC, DRAP Islamabad.
Amlodipine Camsylate: Copy of commercial
not attested by ADC, DRAP.
sign and stamp) for ensuring authenticity of Yes
data / documents.
Yes
Rules, 1978. Yes
 Commercial invoice of Amlodipine camsylate has not been attested by DRAP. Firm has submitted copy
of airway bill.
The firm has requested for Exemption from On-site Investigation of their submitted stability data vide
Letter no. WIP/RGA-001/04/18, dated 05-04-2018 and provided the following documents in conjunction
Date of submission: 06-04-2018 vide diary no. 396 (PEC)
1. Reference of last onsite panel inspection Registration Board decided to approve Registration of
for instant dosage form conducted during “Saferon (Sofosbuvir 400mg) tablets by M/s Wilson
last two years. Pharmaceuticals, I-9 Industrial Area, Islamabad in its
278th Meeting.
Date of Inspection: 10-12-2015 , 19-04-2017 & 20-01-

2018
 Software of HPLC present in the firm is 21CFR
compliant and audit trail on the testing reports was
available and confirmed.
2. Documents for the procurement of API Losartan Potassium: Copy of commercial invoice has
with approval from DRAP (in case of been submitted. The said invoice is attested by ADC,
import). DRAP Islamabad.
Amlodipine Camsylate: Copy of commercial invoice has
been submitted. The said invoice is not attested by ADC,
DRAP. Copy of airway bill has been submitted.
3. Documents for the procurement of Losartan Potassium:
reference standard and impurity  Copy of COA of reference standard has been
standards. submitted
standards
submitted
standards
4. Approval of API/ DML/GMP certificate Losartan Potassium: Copy of GMP certificate
of API manufacturer issued by regulatory (Certificate No. 1704054) for M/s Zhejiang Tianyu
authority of country of origin. Pharmaceutical Co., Ltd. China issued by State Food &
Amlodipine Camsylate: Copy of GMP certificate
(Certificate No. ZJ20130111) for M/s Ami Life Sciences
Pvt. Ltd. India issued by Food & Drug Control
Administration Gujarat, valid upto 09-12-2018.
5. Mechanism for Vendor pre-qualification The firm has submitted photocopy of ‗Work instructions
for Evaluation of Vendors and Suppliers‘.
6. Certificate of analysis of the API, Losartan Potassium:
reference standards and impurity Copy of COA of API (Batch #. 10100-160308) from
standards M/s Zhejiang Tianyu Pharmaceutical Co., Ltd. China
has been submitted
submitted
submitted
 Copy of COA of API (Batch #. AMC021101) from
M/s Ami Life Sciences Pvt. Ltd. India has been
submitted
submitted
submitted
7. Documents for the procurement of The firm has submitted photocopy of Commercial
excipients used in product development? invoices/COAs of all the excipients used in the
formulation of applied product
8. List of qualified staff involved in product The firm has submitted photocopy of List of qualified staff
development with relevant experience. involved in product development section comprising of 9
persons.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted photocopy of ― Protocols/SOP for
development & stability testing of trial the Development of Sofvasc Forte tablets 5/50mg‖.
batches.
three stability batches. Manufacturing Record and Batch Packaging Record of the
following 03 Batches:
Trial# 03 1500 Tablets 02 -2017
11. Record of remaining quantities of
stability batches. Trial No Number Total Packs Remaining
of tablets Packs used for Packs
analysis
Trial# 01 1406 140 20 120
Trial# 02 1407 140 16 124
Trial# 03 1408 140 16 124
QA / QC DATA
12. Record of Digital data logger for Firm has submitted photocopies of data logger record for
temperature and humidity monitoring of Accelerated stability chamber from 01-01-2017 to 12-02-
stability chambers (real time and 2018 and for Real Time stability chamber starting from
accelerated) 01-01-2017 to 05-03-2018.
13. Method used for analysis of API along The firm has submitted photocopy of Raw Material
with COA. Specifications, Raw Material Testing Procedures along
with COAs for Amlodipine camsylate & Losartan
potassium.
14. Method used for analysis of FPP & The firm has submitted photocopy of Finished Product
complete record of testing of stability Testing Procedure for Sofvasc forte 5/50 mg Tablet along
batches (i.e. chromatograms, lab reports, with Stability Study Reports.
raw data sheets etc.)  Raw data sheets for stability studies data has not been
submitted.

Firm has submitted analytical record for system
suitability test wherein the RSD calculated for
injection precision of peak area for both
Amlodipine camsylate & Losartan potassium is
less than 2% wherein in routine analysis firm has
recorded only one injection of Standard solution
for both Assay test and Dissolution test.
15. Reports of stability studies of API from Losartan potassium: The firm has submitted photocopy
manufacturer. of 06 Months Accelerated and 24 Months Real Time
Stability Study Data of 03 Batches from M/s Zhejiang
Tianyu Pharmaceutical Co., Ltd. China
Amlodipine camsylate: The firm has submitted
photocopy of 06 Months Accelerated and 12 Months
Real Time Stability Study Data of 03 Batches from M/s
Ami Life Sciences Pvt. Ltd. India.
16. Analysis reports for excipients used. The firm has submitted photocopy of Analytical reports
of their own for excipients used.
17. Drug-excipients compatibility studies.  The firm has not performed Drug-excipients
compatibility studies and has referred to monographs
from Handbook of Pharmaceutical Excipients, Tests
& Trials and Stability Studies conducted by Wilson‘s
Pharmaceuticals.
18. Record of comparative dissolution data.  Firm has submitted Comparative dissolution study of
their product with Cozaar XQ tablets 5/50mg.
Feature Reference Product of M/s
Product Wilsons
Pharma.
Brand name Cozaar XQ Sofvasc Forte
tablets 5/50mg
5/100mg.
Batch No. NO12989 Trial#. 01
Mfg. date 01-2017 02-2017

Comparative dissolution study was performed in
following media:
i. 0.1N HCl
ii. Acetate Buffer.
iii. Phosphate Buffer
The results submitted by firm show comparable
dissolution profile of reference and applied product.
 Firm has submitted chromatograms of Comparative
Dissolution study.
19. Compliance Record of HPLC software The firm has submitted following:
21CFR & audit trail reports on product  Copy of calibration certificate for HPLC system form
testing. ―Technology Links (Pvt.) Ltd.
 Copy of Audit trail record from January 2017 to
November 2017
Decision: Registration Board decided to approve registration of “Sofvasc Forte film coated tablets
5/100 (Amlodipine as camsylate/Losartan potassium) by M/s Wilson Pharmaceuticals, I-9 Industrial
Area, Islamabad. Manufacturer will place first three production batches on long term stability
studies throughout proposed shelf life and on accelerated studies for six months.
Case No. 5 New DML/Section:
Case. No. : M/s Hudson Pharma, Karachi
Ointment/cream/lotion/gel (General) section of M/s Hudson Pharma (Pvt) Ltd Karachi was approved by
Licensing Board in its 257th meeting. The letter for section approval was issued by Licensing division on
21st February 2018.
1. Ointment/cream/lotion/gel (General) section
Now the firm has applied for following
1 Ointment/cream/lotion/gel (General) 5 3
section
Capsule section (General): Products-18, Molecules-10
90. Name and address of manufacturer / M/s Hudson Pharma (Pvt) Ltd., D-93, North Western
Brand Name +Dosage Form + Strength Acicloson Ointment 5%
PKR 20,000/-30-01-2018
Aciclovir…..50mg
Type of Form Form 5
Pack size & Demanded Price 10g: As per SRO
Approval status of product in Reference Acyclovir 5% ointment by Tolmar
Me-too status Acylex 5% ointment by Ferozesons
acceptable level of compliance to GMP
Remarks of the Evaluator. ● Firm has initially submitted the application on CTD
format on 30-01-2018 without Form 5 and
formulation development and stability studies data as
required in section 3.2.P of module 3 of CTD. Later
the firm has submitted application on Form 5 dated
06-04-2018.
Decision: Approved.
Brand Name +Dosage Form + Strength Acicloson 5% cream
PKR 20,000/-: 30-01-2018
Aciclovir……50mg
Type of Form Form 5
Pack size & Demanded Price 10gm: As per SRO
Approval status of product in Reference Zovirax 5% cream by GSK
Me-too status Zovirax 5% cream by GSK
Remarks of the Evaluator. Firm has initially submitted the application on CTD
format on 30-01-2018 without Form 5 and formulation
development and stability studies data as required in
section 3.2.P of module 3 of CTD. Later the firm has
submitted application on Form 5 dated 06-04-2018.
Decision: Approved.
Brand Name +Dosage Form + Strength Flutison cream 0.05%
PKR 20,000: 30-01-2018
Fluticasone propionate……0.5mg
Pharmacological Group Corticosteroid and anti-inflammatory agent
Type of Form Form 5
Approval status of product in Reference Cutivate 0.05% cream by Galaxo welcome UK
Me-too status Cutivate M Cream 0.05% by GSK
format 30-01-2018 without Form 5 and formulation
Decision: Approved.
Brand Name +Dosage Form + Strength Flutoson ointment 0.005%
PKR 20,000: 30-01-2018
Flutisone propionate…..0.05mg
Pharmacological Group Corticosteroid and anti-inflammatory agent
Type of Form Form 5
Pack size & Demanded Price 10g: As per SRO
Approval status of product in Reference Cutivate 0.005% ointment by Galaxo welcome UK
Me-too status Cutivate 0.005% ointment by GSK
format 30-01-2018 without Form 5 and formulation
Decision: Approved.
Brand Name +Dosage Form + Strength Clotrison HC Cream 1% + 1%
PKR 20,000: 25-01-2018
Clotrimazole…..10mg
Hydrocortisone as acetate…….10mg
Pharmacological Group Antifungal agent
Type of Form Form 5
Approval status of product in Reference Canesten HC Cream by Bayer Plc
Me-too status Hydrozole cream by Stiefel
format on 25-01-2018 without Form 5 and formulation
Case. No. M/s Hudson Pharma (Pvt.) Ltd. Karachi (New Section)
CLB in its 259th meeting held on 29th - 30th March, 2018 has considered and granted the following one
(01) additional sections of M/s Hudson Pharma (Pvt.) Ltd., Karachi.
“Eye/Ear & Nasal Drops (General) section”
Accordingly Secretary Central Licensing Board has issued letter for ―Grant of Additional Section‖ dated
11-04-2018.
Cases of “Eye/Ear & Nasal Drops (General) section” have already been discussed in 277th meeting of
Registration Board, wherein Registration Board deferred all the cases for confirmation of manufacturing
facility. Now the firm has requested to consider only following two molecules on priority.
1 Eye/Ear & Nasal Drops (General) section 2 2
95. Name and address of manufacturer / M/s Hudson Pharma, D-93, North Western
Applicant Industrial Zone, Port Qasim Authority, Karachi
Brand Name +Dosage Form + Strength Travoson Eye Drops 0.004%
Composition Each ml of solution contains:
Travoprost…..40mcg
Diary No. Date of R& I & fee Dy. No. 1868 25-10-2016 , Rs.20,000/- (24-10-2016)
Pharmacological Group Prostaglandin Analogue
Type of Form Form-5
Pack size & Demanded Price 2.5ml LDPE container, As per SRO
Approval status of product in Reference Travatan by Alcon (USFDA approved)
Me-too status Travopt by Barrett Hodgson
Purpose: Routine GMP
Conclusion: The overall cGMP compliance of the
firm with respect to building, facilities and
procedures demonstrated at the time of inspection
found at acceptable level. Moreover, the firm is
advised to submit the action plan on above mentioned
suggestions. The management is also committed for
continual improvement and has assured further
cGMP compliance.
Remarks of the Evaluator. Section: Plastic ampoule BFS technology
Decision of 277th meeting of Registration Deferred for confirmation of manufacturing facility.
Board
Decision: Deferred for clarification from Licensing Division regarding following comments
appearing in the section approval letter for Eye/Ear & Nasal Drops (General) section:
“However, as per commitment, the firm will submit layout plan within three months and
install Autoclave / Sterilization this section within six months.”
96. Name and address of manufacturer / M/s Hudson Pharma, D-93, North Western Industrial
Applicant Zone, Port Qasim Authority, Karachi
Brand Name +Dosage Form + Strength Tearson Eye Drops 0.3%+0.4%
Composition Each ml of solution contains:
Polypropylene glycol…..0.3%
Polyethylene glycol….0.4%
Diary No. Date of R& I & fee Dy. No. 2072, 25-10-2016 , Rs.20,000/- (24-10-
2016)
Pharmacological Group Lubricant
Type of Form Form-5
Pack size & Demanded Price 5ml LDPE container, As per SRO
Me-too status Systane Lubricant Eye Drops M/s Ali Gohar &
Company(Pvt) Ltd., Karachi (Reg.# 0448340)
Purpose: Routine GMP
Conclusion: The overall cGMP compliance of the
firm with respect to building, facilities and
procedures demonstrated at the time of inspection
found at acceptable level. Moreover, the firm is
advised to submit the action plan on above mentioned
suggestions. The management is also committed for
continual improvement and has assured further
cGMP compliance.
Remarks of the Evaluator. Section: Plastic ampoule BFS technology
Decision of 277th meeting of Registration Deferred for confirmation of manufacturing facility.
Board
Decision: Deferred for clarification from Licensing Division regarding following comments
appearing in the section approval letter for Eye/Ear & Nasal Drops (General) section:
“However, as per commitment, the firm will submit layout plan within three months and
install Autoclave / Sterilization this section within six months.”
Case. No.. M/s MedPharm Research Lab, Lahore. (New Licence)
CLB in its 257th meeting held on 24th -25th January 2018 has considered and granted the Drug
Manufacturing License (DML) to M/s MedPharm Research Lab, Lahore and granted Seven (07) new
sections to the firm. Accordingly, firm has applied for following products for consideration by Drug
Registration Board.
1 Dry powder injection (Cephalosporin) 30 10
Section
2 Capsule (Cephalosporin) Section - -
3 Dry Powder Suspension (Cephalosporin) 18 09
Section
4 Tablet (General) Section 24 10
5 Capsule (General) Section - -
6 Dry powder suspension (General) - -
Section
7 Sachet (General) Section - -
Dry Powder Suspension (Cephalosporin) Section
Brand Name +Dosage Form + Strength Medbuten Dry Suspension 90mg /5ml
Ceftibuten (as dihydrate)…90mg
Type of Form Form-5
Finished Product Specification Innovator's specifications
Pack size & Demanded Price 60ml /As per SRO
Approval status of product in Reference CEDAX 90mg/5ml Dry Suspension by M/s Shionogi USA,
Regulatory Authorities. Inc (USFDA approved)
Me-too status Xigris 90mg/5ml Dry Suspension by Wilshire/Horizon
(Reg#053634)
Grant of new DML,
Brand Name +Dosage Form + Strength Medprozil Dry Suspension 125mg /5ml
Cefprozil (as monohydrate)…125mg
Type of Form Form-5
Approval status of product in Reference Cefprozil powder for suspension 125mg/5ml by M/s
Regulatory Authorities. Aurobindo Pharma USA, Inc. (USFDA approved)
Me-too status Vegapro 125mg/5ml dry powder for Suspension by M/s
Vega Pharmaceuticals (Reg. No. 078765).
GMP status 12-01-2018. Grant of new DML,

Decision: Approved.
Brand Name +Dosage Form + Strength Medprozil DS Dry Suspension 250mg /5ml
Cefprozil (as monohydrate)…250mg
Type of Form Form-5
Approval status of product in Reference Cefprozil powder for suspension 250mg/5ml by M/s
Regulatory Authorities. Aurobindo Pharma USA, Inc. (USFDA approved)
Me-too status Vegapro 250mg/5ml dry powder for Suspension by M/s
Vega Pharmaceuticals (Reg. No. 078764)
Grant of new DML,
Decision: Approved.
Brand Name +Dosage Form + Strength Medodoxime Dry Suspension 100mg /5ml
Type of Form Form-5
Approval status of product in Reference Cefpodoxime Proxetil 100 mg/5ml Powder for Oral
Regulatory Authorities. Suspension by M/s Sandoz GMBH, (USFDA approved)
Me-too status Qink Dry Suspension100 mg/5ml by M/s Wilshire
Laboratories (Pvt) Ltd (Reg#053636)
Decision: Approved.
Type of Form Form-5
Approval status of product in Reference Vantin for oral suspension by M/s PHARMACIA AND
Regulatory Authorities. UPJOHN (USFDA approved)
Me-too status Qink Dry Suspension50 mg/5ml by M/s Wilshire
Laboratories (Pvt) Ltd (Reg#060519)
Grant of new DML,
Decision: Approved.
Type of Form Form-5
Approval status of product in Reference Cefpodoxime Proxetil 40 mg/5 ml Powder for Oral
Regulatory Authorities. Suspension by M/s Sandoz GMBH, MHRA approved
Me-too status Apodox 40 mg/5 ml Dry Suspension by M/s Alliance
(Reg#054697)
Grant of new DML,
Decision: Approved.
Brand Name +Dosage Form + Strength Medxime Dry Suspension 100mg /5ml
Cefixime (as trihydrate)…100mg
Type of Form Form-5
Approval status of product in Reference Cefixime 100 mg/5 ml Powder for Oral Suspension by M/s
Regulatory Authorities. Generics [UK] Ltd t/a Mylan (MHRA Approved)
Me-too status Stlicef dry suspension 100mg/5ml by M/s Treat Pharma
(Reg#073247)
Grant of new DML,
Decision: Approved.
Brand Name +Dosage Form + Strength Medxime DS Dry Suspension 200mg /5ml
Cefixime (as trihydrate)…200mg
Type of Form Form-5
Approval status of product in Reference Cefixime for oral suspension 200mg/5ml by M/s Aurobindo
Regulatory Authorities. Pharma (USFDA approved)
Me-too status Biozil Dry Suspension 200mg/5ml by M/s Biolabs
(Reg#054770)
Grant of new DML,
Decision: Approved.
Brand Name +Dosage Form + Strength Medclor Dry Suspension 125mg /5ml
Cefaclor (as monohydrate)…125mg
Type of Form Form-5
(Reg#081617)
Grant of new DML,
Decision: Approved.
Brand Name +Dosage Form + Strength Medclor DS Dry Suspension 250mg /5ml
Cefaclor (as monohydrate)…250mg
Type of Form Form-5
(Reg#081618)
Grant of new DML,
Decision: Approved.
Brand Name +Dosage Form + Strength Medoxim Dry Suspension 125mg /5ml
Cefuroxime (as axetil)…125mg
Type of Form Form-5
Approval status of product in Reference Zinnat Suspension 125mg/5ml by M/s Glaxo Wellcome UK
Me-too status Kefrox Suspension of M/s CCL Pharmaceuticals (Reg.#
026054)
Grant of new DML,
Decision: Approved.
Brand Name +Dosage Form + Strength Medoxim DS Dry Suspension 250mg /5ml
Cefuroxime (as axetil)…250mg
Type of Form Form-5
Approval status of product in Reference Zinnat Suspension 125mg/5ml by M/s Glaxo Wellcome UK
Me-too status Optik DS Dry Suspension of M/s Wilshire Laboratories (Pvt)
Ltd (Reg.# 053644)
Grant of new DML,
Decision: Approved.
Brand Name +Dosage Form + Strength Medoxil Dry Suspension 125mg /5ml
Cefadroxil (as monohydrate)…125mg
Type of Form Form-5
Approval status of product in Reference ORACEFAL 125 mg / 5 ml powder for oral suspension by
Regulatory Authorities. M/s Bristol - Myers Squibb (ANSM Approved)
Me-too status Evacef Suspension 125mg/5ml by M/s Highnoon
Grant of new DML,
Decision: Approved.
Brand Name +Dosage Form + Strength Medoxil DS Dry Suspension 250mg /5ml
Cefadroxil (as monohydrate)…250mg
Type of Form Form-5
Approval status of product in Reference Duricef 250mg/5ml by M/s Warner Chilcott , (USFDA
Me-too status Evacef Suspension 250mg/5ml by M/s Highnoon
Grant of new DML,
Decision: Approved.

Brand Name +Dosage Form + Strength Meddin Dry Suspension 125mg /5ml
Cephradine (as monohydrate)…125mg
Type of Form Form-5
Grant of new DML,

Brand Name +Dosage Form + Strength Meddin DS Dry Suspension 250mg /5ml
Cephradine (as monohydrate)…250mg
Type of Form Form-5
Approval status of product in Reference Cefradine 250mg/5ml dry powder for syrup by M/s Strides
Grant of new DML,
Remarks of the Evaluator. ● Firm applied as Cephradine (as monohydrate) but
approved formulation in MHRA contains Cephradine as
base.
Brand Name +Dosage Form + Strength Mednir Dry Suspension 125mg /5ml
Cefdinir (as monohydrate) …125mg
Type of Form Form-5
Approval status of product in Reference Cefdinir 125mg/5ml powder for Suspension by M/s Lupin
Regulatory Authorities. LTD (USFDA approved)
Me-too status Zefnir 125mg/5ml dry Suspension by M/s Genome
Pharmaceuticals (Reg. No. 075525)
Remarks of the Evaluator. ● Firm applied as Cefdinir (as monohydrate) but approved
formulation in USFDA contains Cefdinir as base.
Brand Name +Dosage Form + Strength Mednir DS Dry Suspension 250mg /5ml
Cefdinir (as monohydrate) …250mg
Type of Form Form-5
Approval status of product in Reference Cefdinir 250mg/5ml powder for Suspension by M/s Lupin
Regulatory Authorities. LTD (USFDA approved)
Me-too status Zefnir 250mg/5ml dry Suspension by M/s Genome
Pharmaceuticals (Reg. No. 075526)
Grant of new DML,
Remarks of the Evaluator. ● Firm applied as Cefdinir (as monohydrate) but approved
formulation in MHRA contains Cefdinir as base.
Tablet (General) Section

24 products/ 10 molecules
Brand Name +Dosage Form + Strength Cipmed Tablet 100mg
Pharmacological Group Fluoroquinolone Antibiotic.
Type of Form Form 5
Approval status of product in Reference Ciprofloxacin 100 mg film-coated tablets by M/s Cipla (EU)
Grant of new DML,
Remarks of the Evaluator. ● Me-too status not confirmed from available database.
me-too status) along with registration number, brand name and name of firm, or else application
on form-5D alongwith differential fee.
Type of Form Form 5
Approval status of product in Reference Ciprofloxacin 250 mg Film-Coated Tablets by M/s Ranbaxy
Regulatory Authorities. (UK) Limited (MHRA Approved)
Me-too status Mercip 250mg tablet by M/s Merck, (Reg#024601)
Grant of new DML,
Decision: Approved.
Type of Form Form 5
Approval status of product in Reference Ciprofloxacin 500 mg Film-Coated Tablets by M/s Teva UK
Me-too status Mercip 500mg Tablet by M/s Merck, (Reg#024602)
Grant of new DML,
Decision: Approved.
Type of Form Form 5
Approval status of product in Reference Ciprofloxacin 750 mg film-coated tablets by M/s Milpharm
Me-too status Cipropar Tablet 750mg by M/s Neomedix Pharmaceuticals
(Reg#081412)
Grant of new DML,
Decision: Approved.

Brand Name +Dosage Form + Strength Cipmed XR Tablet 500mg
Composition Each film coated extended relaese tablet contains:
Type of Form Form 5
Pack size & Demanded Price 10‘s, 14‘s/ As per SRO
Approval status of product in Reference CIPRO XR 500mg Tablet by M/s Bayer Pharmaceuticals
Regulatory Authorities. Corporation (USFDA approved) Formulation is not same as
that of approved in USFDA.
Me-too status Ciprin XR Tablets 500 mg by M/s Werrick Pharmaceuticals
(Reg#044686)
Grant of new DML,
Remarks of the Evaluator. Composition & manufacturing method of applied
formulation is not as per reference product approved by
USFDA.
Decision: Deferred for clarificationof composition & manufacturing method as per reference
product approved by USFDA i.e. Ciproxin XR.

Brand Name +Dosage Form + Strength Cipmed XR Tablet 1000mg
Composition Each film coated extended relaese tablet contains:
Type of Form Form 5
Approval status of product in Reference CIPRO XR 1000mg Tablet by M/s Bayer Pharmaceuticals
Regulatory Authorities. Corporation (USFDA approved) Formulation is not same as
that of approved in USFDA.
Me-too status Ciprin XR Tablets 1000 mg by M/s Werrick
Grant of new DML,
Remarks of the Evaluator. ● Composition & manufacturing method of applied
formulation is not as per reference product approved by
USFDA.
Decision: Deferred for clarificationof composition & manufacturing method as per reference
product approved by USFDA i.e. Ciproxin XR.
Brand Name +Dosage Form + Strength Med-Z Tablet 250mg
Pharmacological Group Macrolide Antibiotic.
Type of Form Form 5
Approval status of product in Reference ZITHROMAX Tablets 250mg by M/s PFIZER (USFDA
Me-too status Zetro 250mg Tablet by M/s Getz Pharma (Reg#066913)
Grant of new DML,
Decision: Approved.
Brand Name +Dosage Form + Strength Med-Z Tablet 500mg
Pharmacological Group Macrolide Antibiotic.
Type of Form Form 5
Approval status of product in Reference ZITHROMAX Tablets 500mg by M/s PFIZER (USFDA
Me-too status Zetro 500mg Tablet by M/s Getz Pharma (Reg#053120)
Grant of new DML,
Decision: Approved.
Brand Name +Dosage Form + Strength Tromed Tablet 10mg
Ketorolac tromethamine …10mg
Pharmacological Group Anti-inflammatory and antirheumatic products, non-steroids
(Acetic acid derivatives and related substances)
Type of Form Form 5
Approval status of product in Reference Ketorolac tromethamine Tablets 10mg by M/s Teva
Me-too status Yukon Tablet 10mg by M/s CCL Pharmaceuticals
(Reg#074285)
Decision: Approved.
Brand Name +Dosage Form + Strength Tromed Tablet 20mg
Ketorolac tromethamine …20mg
Pharmacological Group Anti-inflammatory and antirheumatic products, non-steroids
(Acetic acid derivatives and related substances)
Type of Form Form 5
● Me-too status not confirmed from available database.
· Evidence of applied formulation/drug already approved by DRAP (generic / me-too status)
· Evidence of approval of applied formulation in reference regulatory authorities/agencies which
were declared/approved by the Registration Board.
Brand Name +Dosage Form + Strength Medlee Tablet 2.5mg
Letrozole …2.5mg
Pharmacological Group Aromatase inhibitor
Type of Form Form-5
Approval status of product in Reference Femara Letrozole 2.5 mg Tablets by M/s Novartis
Regulatory Authorities. Pharmaceuticals UK Ltd (MHRA approved)
Me-too status Femara 2.5 mg tablet by M/s Novartis (Reg#021129)
Grant of new DML,

Brand Name +Dosage Form + Strength Med-Live Tablet 250mg
Levetiracetam …250mg
Type of Form Form-5
Approval status of product in Reference Levetiracetam Amneal 250 mg film-coated tablets by M/s
Regulatory Authorities. Amneal Pharma Europe Limited (MHRA approved)
Me-too status Keppra Tablets 250mg by M/s AGP (Private) Limited
(Reg#045684)
Grant of new DML,
Decision: Approved.
Brand Name +Dosage Form + Strength Med-Live Tablet 500mg
Levetiracetam …500mg
Type of Form Form-5
Approval status of product in Reference Levetiracetam Amneal 500 mg film-coated tablets by M/s
Regulatory Authorities. Amneal Pharma Europe Limited (MHRA approved)
Me-too status Keppra Tablets 500mg by M/s AGP (Private) Limited
(Reg#045685)
Grant of new DML,
Decision: Approved.
Brand Name +Dosage Form + Strength Dezil Tablet 400mg
Linezolid…400mg
Pharmacological Group Oxazolidone Antibiotic
Type of Form Form-5
Pack size & Demanded Price 10‘s, 12‘s, 14‘s/ As per SRO
Approval status of product in Reference ZYVOX 400mg tablets by M/s Pharmacia and Upjohn
Me-too status Zoxin 400mg Tablets by M/s SJ & G Fazul Ellahie
(Reg#034783)
Grant of new DML,
Brand Name +Dosage Form + Strength Dezil Tablet 600mg
Linezolid…600mg
Pharmacological Group Oxazolidone Antibiotic
Type of Form Form-5
Pack size & Demanded Price 10‘s, 12‘s, 14‘s/ As per SRO
Approval status of product in Reference Zyvox 600 mg film-coated tablets by M/s Pharmacia
Me-too status Ecasil 600mg tablet by M/s Sami (Reg#066904)
Grant of new DML,
Brand Name +Dosage Form + Strength Levomed Tablet 250mg
Type of Form Form 5
Me-too status Lazer 250mg Tablet by M/s Foray Pharmaceutical
(Reg No:040615)
Grant of new DML,
Type of Form Form 5
Me-too status Lazer 500mg Tablet by M/s Foray Pharmaceutical
(Reg No:040614)
Grant of new DML,
Type of Form Form 5
Approval status of product in Reference Levofloxacin tablet, film coated 750mg by M/s Sandoz Inc
Me-too status Leflox 750mg Tablets by M/s Getz Pharma (Reg#047118)
Grant of new DML,
Brand Name +Dosage Form + Strength Acetal Tablet 37.5mg/325mg
Tramadol...37.5mg
Paracetamol ...325mg.
Pharmacological Group Opioids Analgesic, NSAID
Type of Form Form-5
Approval status of product in Reference Tramacet 37.5mg/325mg Film coated tablets by M/s
Regulatory Authorities. Grünenthal Ltd, (MHRA approved)
Me-too status Forgesil Tablet37.5mg/325mg by M/s Foray (Reg#080874)
Grant of new DML,
Decision: Approved.
Brand Name +Dosage Form + Strength Telmo Tablet 10mg/40mg
Amlodipine (as besylate) …10mg
Telmisartan …40mg.
Pharmacological Group Angiotensin II antagonists and calcium channel blockers
Type of Form Form-5
Approval status of product in Reference Telmisartan and amlodipine tablet 10mg/40mg by M/s Mylan
Regulatory Authorities. Pharmaceuticals Inc. (USFDAA approved)
Me-too status Amtas 10mg +40mg Tablet by M/s Getz Pharma (Pvt) Ltd
(Reg#066945)
Grant of new DML,
Remarks of the Evaluator. ● In reference regulatory authorities like in EMA and
USFDA the applied drug is multi-layered tablet, while
the applied drug is single layered tablet.
Decision: Deferred for the clarification of manufacturing outline as in reference regulatory
authorities the approved drug is multilayered tablet, while the applied drug is mono layered
tablet.
Type of Form Form-5
Approval status of product in Reference Telmisartan and amlodipine tablet 5mg/40mg by M/s Mylan
Regulatory Authorities. Pharmaceuticals Inc. (USFDAA approved)
(Reg#066943)
Grant of new DML,
tablet.
Type of Form Form-5
Approval status of product in Telmisartan and amlodipine tablet 5mg/80mg by M/s Mylan
Reference Regulatory Authorities. Pharmaceuticals Inc. (USFDAA approved)
(Reg#066944)
Grant of new DML,
USFDA the applied drug is multi-layered tablet, while the
applied drug is single layered tablet.
tablet.
Type of Form Form-5
Approval status of product in Reference Telmisartan and amlodipine tablet 10mg/80mg by M/s
Regulatory Authorities. Mylan Pharmaceuticals Inc. (USFDAA approved)
Me-too status Telsarta-A 10/80 Tablet by M/s Pharmevo (Reg#073767)
Grant of new DML,
tablet.
Brand Name +Dosage Form + Strength Medolid Tablet 100mg
Nimesulide …100mg
Pharmacological Group Antiinflammatory preparations, non-steroids for topical use
Type of Form Form-5
Approval status of product in Reference Approved by EMA
Me-too status Nims 100mg tablets by M/s Sami Pharmaceuticals (Pvt) Ltd
(Reg#026657)
Grant of new DML,
Decision: Registration Board approved the formulation of Nimesulide Tablets 100mg with a pack
size of 15 tablets as per recommendations of EMA only for the following clinical indications as a
second line choice.
● Treatment of acute pain
● Primary dysmenorrhea.
Case. No.5: M/s Atco Laboratories Ltd, Karachi (New Section)
CLB in its 252nd meeting held on 15th March 2017 has considered and granted additional section to M/s Atco
Laboratories Ltd. Accordingly, firm has applied for following products for consideration by Drug Registration
Board.
Section No. of products No. of molecules

Ointment (Steroid) section 08 04
Ointment (Steroid) section

139. Name and Address of Manufacturer / M/s Atco Laboratories Ltd,
Applicant B-18, S.I.T.E, Karachi.
Brand Name + Dosage Form + Strength Troban Cream 2%w/w
Mupirocin (as calcium dihydrate) …20mg (2%w/w)
Pharmacological Group Other antibiotics for topical use
Type of Form Form-5
Pack Size & Demanded Price 5g/ Rs. 250/-,
10g/ Rs. 500/-,
15g/ Rs. 750/-,
30g/ Rs. 1500/-.
Approval Status of Product in Reference Bactroban 2% cream by M/s GlaxoSmithKline (USFDA
Me-too Status Mupiderm 2% Cream by M/s Tabros (Reg#070685)
Overall GMP is good
Decision: Approved.

Brand Name + Dosage Form + Strength Troban Ointment 2%w/w
Mupirocin …20mg (2%w/w)
Pharmacological Group Other antibiotics for topical use
Type of Form Form-5
10g/ Rs. 500/-,
15g/ Rs. 750/-,
30g/ Rs. 1500/-.
Approval Status of Product in Reference Bactroban 2% Ointment by M/s GlaxoSmithKline (MHRA
Me-too Status Bactroban 2% Ointment by M/s GlaxoSmithKline
(Reg#010399)
Overall GMP is good
Decision: Approved.
Brand Name + Dosage Form + Strength Elvicon Cream 0.1%w/w
Mometasone furoate …1mg (0.1%w/w)
Type of Form Form-5
10g/ Rs. 500/-,
15g/ Rs. 750/-,
20g/ Rs. 1000/-,
30g/ Rs. 1500/-.
Approval Status of Product in Reference Elocon 0.1% w/w Cream by M/s : B&S Healthcare (MHRA
Me-too Status Hivate Cream 0.1%w/w by M/s Saffron Pharmaceuticals
Overall GMP is good
Decision: Approved.
Brand Name + Dosage Form + Strength Elvicon Ointment 0.1%w/w
Mometasone furoate …1mg (0.1%w/w)
Type of Form Form-5
10g/ Rs. 500/-,
15g/ Rs. 750/-,
20g/ Rs. 1000/-,
30g/ Rs. 1500/-.
Approval Status of Product in Reference Elocon 0.1% w/w Ointment by M/s B&S Healthcare
Me-too Status Hivate Ointment 0.1%w/w by M/s Saffron Pharmaceuticals
Overall GMP is good
Decision: Approved.
Brand Name + Dosage Form + Strength Tazaro Cream 0.1%w/w
Tazarotene …1mg (0.1%w/w)
Pharmacological Group Other antipsoriatics for topical use
Type of Form Form-5
10g/ Rs. 1550/-,
15g/ Rs. 2325/-,
20g/ Rs. 3100/-.
Approval Status of Product in Reference AVAGE (tazarotene) cream 0.1%w/w by M/s Allergan.
Me-too Status Taz 0.1%w/w cream by M/s Tabros Pharma (Reg#081185)
Overall GMP is good
Brand Name + Dosage Form + Strength Tazaro Gel 0.1%w/w
Diary No. Date of R & I & fee Diary No:17518, 09/10/2017, Rs: 20,000/- (Duplicate)
Challan no: 0581280
Tazarotene …1mg (0.1%w/w)
Type of Form Form-5
10g/ Rs. 1550/-,
15g/ Rs. 2325/-,
20g/ Rs. 3100/-.
Approval Status of Product in Reference ZORAC 0.1%, gel by M/s Allergan Pharmaceuticals Ireland
Me-too Status Trazene 0.1% Gel by M/s PharmEvo (Pvt.) Ltd.
(Reg#057747)
Overall GMP is good

Brand Name + Dosage Form + Strength Tazaro Gel 0.05%w/w
Tazarotene …0.5mg (0.05%w/w)
Type of Form Form-5
10g/ Rs. 1000/-,
15g/ Rs. 1500/-,
20g/ Rs. 2000/-.
Approval Status of Product in Reference ZORAC 0.05%, gel by M/s Allergan Pharmaceuticals
Regulatory Authorities. Ireland (MHRA Approved)
Me-too Status Trazene 0.05% Gel by M/s PharmEvo (Pvt.) Ltd.
(Reg#057748)
Overall GMP is good

Brand Name + Dosage Form + Strength Acsolve Plus Gel
Clindamycin (as phosphate) …10mg (1%w/w)
Anhydrous benzoyl peroxide (as hydrous benzoyl peroxide)
… 50mg (5%w/w)
Pharmacological Group Antiinfectives for treatment of acne
Type of Form Form-5
10g/ Rs. 1000/-,
15g/ Rs. 1500/-,
20g/ Rs. 2000/-,
25g/ Rs. 2500/-,
30g/ Rs. 3000/-.
Approval Status of Product in Reference Duac Once Daily 10 mg/g + 50 mg/g Gel by M/s Allergan
Regulatory Authorities. Pharmaceuticals Ireland (MHRA Approved)
Me-too Status Duac Once Daily Gel by M/s Stiefel Laboratories Pakistan
Overall GMP is good
Case No. 6 Registration applications of categories to be considered on priority

a. Export facilitation
PEC-VI
Export Facilitation: Application was received through letter No.F.7-7/2017-Reg-II, The firm claimed 1
molecules to be considered on priority‖.
147. Name and address of manufacturer / M/s Medisure Laboratories Karachi
Applicant
Brand Name +Dosage Form + Strength Januet 50/1000mg tablets

Sitagliptin(as phosphate monohydrate)… …….50mg
Type of Form Form-5
compliance of GMP.
sent to Budget & Accounts Division for verification of challan and Board authorized its
Chairman for the issuance of registration letter.
148. Name and address of manufacturer / M/s Medisure Laboratories Karachi

Applicant
Brand Name +Dosage Form + Strength Januet 50/500mg tablets
Sitagliptin (as phosphate monohydrate)… …….50mg
Type of Form Form-5
GMP status Last inspection was conducted on 05-12-2017 for renewal
/ grant of GMP Certificate and the report concludes good
compliance of GMP.
sent to Budget & Accounts Division for verification of challan and Board authorized its
Chairman for the issuance of registration letter.
B. Pharmacy Services Division
Case No. 1 DRUG SAFETY PACKAGE INSERTS/ PRESCRIBING INFORMATION

UPDATES OF CLARITHROMYCIN.
US-FDA in February, 2018 has issued drug safety communications regarding

Clarithromycin antibiotic wherein caution was advised before prescribing Clarithromycin to
patients with heart disease because of a potential increased risk of heart problems or death that
can occur years later after the treatment. FDA‘s recommendation was based on their review of the
result of a 10-years follow-up study of patients with coronary heart disease that was first observed
in a large clinical trial (CLARICOR TRIAL, 2006). As result of this study, US-FDA has
recommended to add a new warning in the prescribing information of Clarithromycin.
The abstract of the 10 years study is as under:
Clarithromycin for stable coronary heart disease increases all-cause and cardiovascular
mortality and cerebrovascular morbidity over 10 years in the CLARICOR randomised, blinded
clinical trial.
Background: The CLARICOR trial reported that clarithromycin compared with placebo increased
all-cause mortality in patients with stable coronary heart disease. This study investigates the effects of
clarithromycin versus placebo during 10 years follow up.
Methods: The CLARICOR trial is a randomised, placebo-controlled trial including 4373 patients
with stable coronary heart disease. The interventions were 2 weeks of clarithromycin 500 mg a day
versus placebo.10 year follow up was performed through Danish public registers and analysed with
Cox regression.
Results: Clarithromycin increased all-cause mortality (hazard ratio (HR): 1.10, 95% confidence
interval (CI): 1.00–1.21) and cerebrovascular disease during 10 years (HR: 1.19, 95% CI: 1.02–1.38).
The increased mortality and morbidity were restricted to patients not on statin at entry (HR: 1.16,
95% CI: 1.04–1.31, and HR: 1.25, 95% CI: 1.03–1.50). The assumption of constant HR during the 10
years was violated for cardiovascular death (P =0.01) and cardiovascular death outside hospital (P b
0.0005). Analyses of the effects over time showed that clarithromycin increased cardiovascular
mortality during the first three years (HR: 1.42, 95% CI: 1.09–1.84)
due to increased cardiovascular mortality outside hospital in patients not on statin (HR: 2.36, 95% CI:
1.60–3.50). During the last 4 years, cardiovascular death outside hospital was lower in the
clarithromycin group (HR: 0.64, 95% CI: 0.46–0.88).
Conclusion: Clarithromycin increased mortality due to cardiovascular death outside hospital and
cerebrovascular morbidity in patients with stable coronary heart disease who were not on statin. The
increased cardiovascular mortality was years later compensated, likely through frailty attrition.
Reference: International Journal of Cardiology 182 (2015) 459-565.
Decision: Registration Board deliberated the case and decided as follows:
1. All those licensee manufacturing clarithromycin shall update the package

inserts/ prescribing information of Clarithromycin in line with US-FDA’s label
update and include the following in the warning and precaution section of
package insert:
All-Cause Mortality in Patients with Coronary Artery Disease 1 to 10 years
After Clarithromycin Exposure.
In one clinical trial evaluating treatment with clarithromycin on outcomes in patients

with coronary artery disease, an increase in risk of all-cause mortality one year or
more after the end of treatment was observed in patients randomized to receive
clarithromycin. Consider balancing this potential risk with the treatment benefits
when prescribing Clarithromycin in patients who have suspected or confirmed
coronary artery disease.
2. Pharma Bureau and Pakistan Pharmaceutical Manufacturing Association

(PPMA) shall be advised to ensure compliance of the aforementioned update of
Clarithromycin by the firms.
Case No.2 DRUG SAFETY PACKAGE INSERTS/ PRESCRIBING INFORMATION

UPDATES OF CANAGLIFLOZIN.
European Medicines Agency (EMA) in February, 2017 has informed about the
potential increase risk of lower limb amputation in patients-taking the sodium-glucose co-
transporter-2 (SGLT2) inhibitors canagliflozin, dapagliflozin and empagliflozin and had
recommended to include the warning of the potential increase risk of toe amputation in the
prescribing information for these medicines. The review of SGLT2 inhibitors was prompted due
to an increase in lower limb amputations in patients taking canagliflozin in two clinical trials,
namely: CANVAS (Canagliflozin Cardiovascular Assessment Study); and CANVAS-R (Effects
of Canagliflozin on Renal Endpoints in Adult with Type-2 Diabetes Mellitus).
Similarly, US-FDA in May, 2017 had requested that product label for canagliflozin
is updated to include the risk of leg and foot amputations. US-FDA had given its recommendation
of canagliflozin in package inserts update consequent upon the final results from the CANVAS
and CANVAS-R clinical trials, which showed that leg amputations occurred twice as often in
patients treated with canagliflozin compared to patients treated with placebo.
An approximately 2-fold increased risk of lower limb amputations associated with

Canagliflozin use was observed in CANVAS and CANVAS-R, two large, randomized, placebo-
controlled trials evaluating patients with type 2 diabetes who had either established cardiovascular
disease or were at risk for cardiovascular disease. In CANVAS, Canagliflozin -treated patients
and placebo-treated patients had 5.9 and 2.8 amputations per 1000 patients per year, respectively.
In CANVAS-R, Canagliflozin -treated patients and placebo-treated patients had 7.5 and 4.2
amputations per 1000 patients per year, respectively. The risk of lower limb amputations was
observed at both the 100 mg and 300 mg once daily dosage regimens. Amputations of toe and
midfoot were the most frequent; however, amputation involving leg, below and above the knee
were also observed. Lower limb infections, gangrene, and diabetic foot ulcers were the most
common precipitating medical events leading to the need for an amputation. The risk of
amputation was highest in patients with a baseline history of prior amputation, peripheral vascular
disease, and neuropathy.
Canagliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor that is used

with diet and exercise to lower blood sugar in adults with type-2 diabetes mellitus and is not used
in diabetes mellitus type-1 or diabetic ketoacidosis. The Drug Registration Board in its 275th
meeting has approved registration of Canagliflozin tablet 100mg & 300mg.
Decision: Registration Board deliberated the case and decided as follows:
1. Registration holders of Canagliflozin shall update the warning and

precaution section of the package inserts in line with US-FDA label update
and create box warning in the package inserts/ prescribing information and
on the packing of the Canagliflozin as under:
BOX WARNING: LOWER LIMB AMPUTATION
• In patients with type 2 diabetes who have established cardiovascular
disease (CVD) or at risk for CVD, Canagliflozin [brand name] has been associated
with two fold increase in risk of lower limb amputations, most frequently of the
toe and midfoot; however, amputations involving the leg were also observed. Some
patients had multiple amputations, some involving both limbs.
• Before initiating, consider factors that may increase the risk of
amputations, such as history of prior amputation, peripheral vascular disease,
neuropathy, and diabetic foot ulcers.
 Monitor patients receiving Canagliflozin [brand name] for infection, new pain or
tenderness, sores or ulcers involving the lower limbs, and discontinue if these
complications occur.
2. Pharma Bureau and Pakistan Pharmaceutical Manufacturing Association

(PPMA) shall be advised to ensure compliance of the aforementioned update
of Canagliflozin by the firms.
C. Registration-I Section
Case.No.1 Request of M/s. Sanofi-aventis Pakistan Limited, Karachi for change of
manufacturing site.
M/s Sanofi-aventis Pakistan Limited, plot No. 23, sector No. 22, Korangi Industrial Area, Karachi
has submitted an application for change of manufacturing site from Brazil to France of their approved
product Glucantime (Meglumine antimonite) 1.5g/5ml solution for injection. The firm deposited requisite
fee of Rs.100,000/- for approval. Detail of manufacturer is as under: -
Old Manufacturer (approved in 264th RB- New Manufacturer/ Marketing Authorization Holder
meeting) (as per provided CoPP)
M/s. Sanofi-aventis Farmaceutica Ltda Rua Manufacturer:

Conde Domingos Papais, 413 Jardim Natal
Suzano, Brazil. M/s. Haupt Pharma Livron-Livron Sur Drome, 1 rue
Comte de Sinard, Livron Sur Drome, 26250 France.
Marketing Authorization Holder:
M/s Sanofi-aventis, France, 82 avenue Raspail

94250 Gentilliy, France.
The brief history of the case is as under:

i. The product was approved in 264th meeting of Registration Board held on 28th -
29th December, 2016 as per following details under: -
S. Name of Name of Drug/composition Decision of
No. importer/manufacturer Board/remarks
1. M/s. Sanofi Aventis PakistanGlucantime ® 1.5g/5ml Solution for Approved. Inspection of

Limited, Plot No. 23, SectorInjection manufacturing unit will
No.22, Korangi Industrial Each 5ml, etc. contains:- be considered as per
Area, Karachi. / Meglumine antimoniate
Import Policy for
……1.5g
Sanofi Aventis Farmaceutica (Equivalent to Finished Drugs.
Ltda Rua Conde Domingos antimony)……45667…0.405g
Papais, 413 Jardim Natal Specifications are not provided
Antileshmanial
Suzano, Brazil.
ii. Later, the firm applied for exemption from inspection of manufacturer located in
Brazil i.e M/s. Sanofi-aventis Farmaceutica Ltda Rua Conde Domingos Papais,
413 Jardim Natal Suzano, based on GMP certificate issued by TGA. However,
the GMP certificate provided by the firm mentions non-sterile oral liquid,
suspension and tablet manufacturing facility whereas the dosage forms for whom
the exemption is requested i.e injection is not covered in the certificate of GMP
compliance of the aforesaid manufacturer and the firm was informed
accordingly.
iii. Now the firm has requested for change of manufacturing site for the said product
from Brazil to France and provided the following documents;
a. Copy of CoPP and GMP certificate (issued by French authority) of new
manufacturing site i.e M/s. Haupt Pharma Livron 1, rue comte de sinard
26250 livron France.
b. Fee of Rs.100,000/-
c. An undertaking that they have initiated the process of legalization of
CoPP and GMP certificate for new manufacturing site and will be
submitted the same as soon as received.
It is pertinent to mention that in a meeting of representative of WHO and representative of

Program on Malaria Control (M/o NHSR&C) with CEO, DRAP it has been has informed about ongoing
outbreak situation of Cuteanous Leishmaniasis (CL) in Blochistan, KPK and FATA region heneincreasing
provinicial demand of medicine Glucantime injection which is only recommended treatment in Pakistan.
The representative of WHO has requested DRAP to facilitate the early provision of said drug that will be
purchased by Provincial Governments for treatment of patients.
M/s. Sanofi-aventis Pakistan Limited, Karachi, being the market authorization holder of the said
product in Pakistan, was informed accordingly in the same meeting to make necessary arrangements for
availability of the product.
The firm informed that the source of the said product is in process of shifting from Brazil to
France and now provided the above stated documents for approval of the new manufacturing site.
Decision:- Registration Board deliberated the case in detail, and keeping in view the public
health urgency as pointed-out by WHO, decided to approve the change in
manufacturing site from M/s. Sanofi-aventis Farmaceutica Ltda Rua Conde Domingos
Papais, 413 Jardim Natal Suzano, Brazil to M/s. Haupt Pharma Livron-Livron Sur
Drome, 1 rue Comte de Sinard, Livron Sur Drome, 26250 France for already
approved product Glucantime ® 1.5g/5ml Solution for Injection, subject to provision
of original & legalized CoPP or GMP certificate alongwith free sale certificate. The
Board, further, authorized its Chairman for issuance of registration letter after
provision of said documents.
The Board also approved the market authorization holder for the said
product as M/s Sanofi-aventis, France, 82 avenue Raspail 94250 Gentilliy, France.
The Board further observed that the relaxation given in the decision is for meeting
public health urgency situation arising out of exceptional circumstance and,
therefore, should not be made as precedent in future.
Case.No.2 Request of M/s. Otsuka Pakistan Limited for change of manufacturer from
M/s. Otsuka Japan to M/s. Otsuka Korea and permanent import permission
in finished form of registered products pletaal 50mg and 100mg.
M/s Otsuka Pakistan Ltd, Balochistan has requested for change of manufacturing site and
permanent import permission in finished form of their already registered products Pletaal 50mg & 100mg
Tablet as per details given below: -
S. Name of Drugs / Composition / New Proposed Site / Product

Existing Approved Site
No Reg. No. License Holder (as per COPP)
1. Pletaal 50mgTablet Manufacturer: Name & Address of
Each tablet contains: - M/s Otsuka Manufacturer & Product
Cilostazole……50mg. Pharmaceutical Co.,Ltd, License Holder:
Kandu Tsukasa-cho, M/s Korea Otsuka Pharmaceutical
Reg. No.029294. Chiyoda-Ku, Tokyo, Co., Ltd, 27, Jeyakgongdan 3-gil,
1018535, Japan. Hyangnam-eup, Hwaseong-si,
Gyeonggi-do, Republic of Korea.
2. Pletaal 100mg Tablet -do- -do-
Each tablet contains: -
Cilostazole……100mg.
Reg. No.029295.
The firm has submitted the following supporting documents: -
a) Application on Form-5A.
b) Copy of fee deposit slip of Rs.100,000/- for each product.
c) Copy of initial registration letters with renewal status (as permission for import in
finished form dated 04-03-2018).
d) Original and legalized certificate of pharmaceutical manufacturing license issued by
Korean authority.
e) Original and legalized free sale certificate issued by Korean authority for both
products.
f) Original and legalized GMP certificate issued by Korean authority.
g) Original and legalized CoPP issued by Korean authority for both products.
h) Finished product specification mentioned as ―J.P‖
The brief history of the case is as under:
a. Both products were initially registered in favor of M/s Otsuka Pakistan Ltd,
Lasbella Balochistan to be imported in bulk from M/s Otsuka Japan and toll
repacking at M/s Efroze Chemical Industries, Karachi for a period of two years.
b. Later the firm has been granted twice extension in permission for bulk import and
local repacking at the same site i.e. M/s Efroze Chemical Industries, Karachi. The
Board also decided in its 222nd meeting that no further extension will be granted
and the firm should develop facility for these products.
c. Furthermore, Registration Board in its 236 and 247th meetings granted approval for
import of above mentioned products in finish form from M/s Otsuka Japan for a
period of 18 months and two years respectively.
d. Now the firm has requested for change of manufacturing site from M/s. Otsuka
Japan to M/s. Otsuka Korea and permission (permanent) for import of said
products in finished form from M/s. Otsuka Korea.
The firm has also informed that the inspection of same manufacturer i.e M/s. Otsuka Korea has
already been carried out by a panel nominated by DRAP. The said inspection has been carried out
by a panel comprised of Dr.Saif-ur-Rehman Khattak and Mr. Salateen Waseem Philip on 16-17th
June, 2014.
It is pertinent to inform that the copy of fee challan submitted by the firm is for the purpose of
renewal of registration of product.
Decision:- Registration Board deferred the case for provision of requisite fee for the said
purpose.
Case.No.3 Request of M/s. Fresenius Medical Care Pakistan (Pvt) Ltd, 137-A, Faisal
Town, Lahore for change of manufacturing site for registered products.
M/s. Fresenius Medical Care Pakistan (Pvt) Ltd, 137-A, Faisal Town, Lahore has applied
for change of manufacturing site / source of their following already registered products as per
details given below: -
S. Reg.No. Existing New Proposed Site / Product

Name of Drugs / Composition /
approved site License Holder (as per
No Reg. No.
(manufacturer) COPP)
1. 039884 CAPD/DPCA 2 Stay safe M/s Fresenius Name & Address of

Peritoneal Dialysis Solution. Medical Care Manufacturer:
As per initial reg.letter Deutschland
Each Liter contains: - M/s. Fresenius Medical Care
GmbH, St.
Sodium Chloride 5.786gm. Production SDN, BHD. Lot
Sodium Lactate 3.925gm. Wendel, Germany.
34618, PT 29466, Techpark @
Calcium Chloride 0.2573gm.
Enstek, Bandar Enstek Nilai,
Magnesium Chloride 0.1017gm.
Glucose Monohydrate 16.5gm 71760 Negeri Sembilan,
(Anhydrous glucose 15gm.) Malaysia.
As per Form-5A & COPP.
Each Liter contains: - Product License Holder:
Sodium Chloride 5.786gm.
Sodium Lactate 3.925gm. M/s Fresenius Medical Care
Calcium Chloride Dihydrate Malaysia Sdn. Bhd. Second
0.2573gm Floor Axis Technology Centre,
Magnesium Chloride Lot 13 Jalan 51 A/225, 46100
Hexahydrate 0.1017gm Petaling Jaya, Malaysia.
Glucose Monohydrate 16.5gm.
2. 039886 CAPD/DPCA 3 Stay safe -do- -do-
Peritoneal Dialysis Solution.
As per initial reg.letter.
Each Liter contains: -
Sodium Lactate 3.925gm.
Glucose Monohydrate 46.75gm
(Anhydrous glucose 42.5gm)
Sodium Chloride 5.786gm
Sodium Lactate 3.925gm
Calcium Chloride Dihydrate
0.2573gm
Magnesium Chloride
Hexahydrate 0.1017gm
3. 039887 CAPD/DPCA 4 Stay safe -do- -do-
Peritoneal Dialysis Solution.
As per initial reg.letter.
Sodium Lactate 3.925gm.
(Anhydrous glucose 22.73gm)
Sodium Chloride 5.786gm
Sodium Lactate 3.925gm
Calcium Chloride Dihydrate
0.2573gm
Magnesium Chloride
Hexahydrate 0.1017gm
The firm has deposited fee of Rs.50,000/- (for each product) with following supporting documents.
a) Application on Form-5A.
b) Original CoPP issued by Malaysia Drug Control Authority for new manufacturing
site.
c) Authorization letter in original.
d) Copy of GMP Certificate for new manufacturing site issued by Ministry of Health
Malaysia.
e) Copy of initial registration letter and post registration variations.
f) Site master file of new manufacturing site.
The last renewal of the products has been submitted after due date but with 60 days of
time with double fee.
Decision:- Registration Board deferred the case for confirmation of renewal status from
RRR section as the firm has submitted for last renewal of the said products
after due date but within sixty days of expiry of validity with double fee.
Case.No.4 Request of M/s. PharmEvo (Pvt) Limited, Karachi for exemption from
inspection of manufacturer abroad.
The following products of M/s. PharmEvo (Pvt) Limited, Karachi was approved by
Registration Board in its 226th meeting held on 20th -21st July, 2010 as per following details:-
S. Name of importer/ Product Name & Demanded Pack Decision/Remarks

No manufacturer Composition size & MRP
1. M/s. PharmEvo (Pvt) Trugem 1gm Injection Rs.13500/1‘s Approved.
Ltd Karachi Each vial contains; -
M/s. Jiangsu Hansoh Gemcitabine….1gm
Pharmaceutical Co
Ltd., Economic & 03 years
Technical Development
Zone, Lianyungang
City, Jiangsu, China.
2. -do- Trugem 0.2gm Injection Rs.2800/1‘s Approved
Each vial contains; -
Gemcitabine….0.2gm
03 years
Now the firm has requested for exemption from inspection of manufacturer located in
China (i.e M/s. Jiangsu Hansoh Pharmaceutical Co Ltd., Economic & Technical Development
Zone, Lianyungang City, Jiangsu, China) and provided legalized and attested GMP certificate
alongwith issued by PMDA Japan alongwith English translation.
The said GMP certificate mentions the name of product ―Pemetrexed for Intravenous
infusion 100mg Hengrui‖. Furthermore, the GMP certificate mentions the inspection results as
―The Pharmaceuticals and Medical Devices Agency identified no particular problems as a result
of the compliance inspection, based on regulations under Article 14-6 of the PMDA Act.‖
Decision:- Registration Board, in the light of Policy for Finished Drug Registration,
approved M/s. PharmEvo (Pvt) Limited, Karachi’s request for exemption
from inspection of manufacturer located in China i.e M/s. Jiangsu Hansoh
Pharmaceutical Co Ltd., Economic & Technical Development Zone,
Lianyungang City, Jiangsu, China for approved products Gemcitabine 1gm
and 0.2gm on the basis of approval of the said facility by PMDA Japan.
Case.No.5 Requirement of Legalization/Attestation of Documents of Imported Drugs

While processing cases for registration and post registration variation of imported drugs a
number of important/critical documents like CoPP, GMP, FSC etc issued by regulatory authority
of exporting countries/other concerned organizations, as per practice, are required to be legalized
and attested by Pakistan embassy of exporting country in order to ensure their authenticity.
However, at times some firms have reported problems in getting these documents attested
by the Pakistan embassy of exporting countries. Though, the Registration Board in past, while
considering individual cases, have specified these requirements, however, in order to avoid such
problems, a clear general guidelines in this regard may be required.
Decision:- Registration Board clarifies that important/critical documents prescribed for
registration/post registration variation etc including certificate of
pharmaceutical product (CoPP), free sale certificate (FSC), GMP certificate
etc are required to be duly legalized by the concerned authorities of country of
origin and also attested from Pakistan Embassy in that country.
Case.No.6 CONSTITUTION OF EXPERT WORKING GROUP FOR EVALUATION

OF VETERINARY DRUG CASES.
The Registration Board in its 279th meeting considered the possibility of constitution of an
expert group for its assistance regarding matters relating to veterinary drugs. The Board was
informed that the veterinary expert Committee has already been notified under Section 10 of
Drugs Act, 1976 vide SRO No.81(I)/2015 dated 26-01-2015. So far no meeting has been called
for the Committee.
Decision:- The Board observed that the constitution of the veterinary expert Committee
notified under Section 10 of Drugs Act, 1976 vide SRO No.81(I)/2015 dated
26-01-2015 needs to be revised for inclusion of relevant expert(s) member(s) of
the Board etc. However, since process of revision of constitution may take
some time as the approval of Federal Government and other relevant
organizations are required before revised Gazette notification, so, in order to
avoid pendency/delay in processing of issues relating to veterinary drugs
requiring input/recommendation of pertinent veterinary expert, the Board
decided to constitute an Expert Working Group on Veterinary Drugs having
following composition: -
1. Dr. Qurban Ali, Ex-Director General Chairman
National Veterinary Laboratory, Islamabad.
Expert Member Veterinary Drugs
2. Animal Husbandry Commissioner or his representative, Member
M/o National Food Security & Research, Islamabad.
3. Dr.Mazhar-ul-Haq Member
Veterinary Pharmacologist
Arid Agriculture University, Rawalpindi.
4. Any other relevant expert(s) As Co-opted member(s)
5. Deputy Director (Reg-I), DRAP Member, Secretary
The expert working group will provide expert advice / views and
recommendations to the Registration Board on matters relating to veterinary
drugs referred by the Board including review of existing/new veterinary drug
formulations. The group can Co-opt any relevant expert(s) as Co-opted
member(s).
The Board further advised that in order to avoid any pendency, the “expert
working group” needs be notified immediately without waiting till formal
approval of the minutes of 281st meeting so that the meeting of the expert
working group may be called earlier.
D. Registration-II Section
Case No.7 Products of M/s Akhai Pharmaceuticals (Pvt) Limited, Baluchistan.

M/s Akhai Pharmaceuticals, Baluchistan have requested for registration of their
following products which were deferred in 242nd meeting of Registration Board due to the reasons
mentioned in the last column of the table below:
S.No. Name of Drug(s) & composition Form, Diary, Section Decision in
Fee Approval 242nd Meeting
of Registration
Board
1 Cortimol Cream Form-5 Manufacturers. Deferred for
Each gm contains: Fast Track
Cream / confirmation of
Hydrocortisone ……1% As per PRC
Ointment manufacturing
Clotrimazole………1 % 4.31-05-2012
General (No. F. requirements
4.Dermatological Dy.No.871
4-2/2005-Lic for steroidal
Rs.8000/-
dated preparations
(Original)
20/06/2008)
31-7-2013
Inspection
Rs.52,000/-
report dated
11/10/2011
provided.
2 Steron Cream Form-5 Manufacturers. Deferred for
Each gram contains:- Fast Track Cream / confirmation of
Isoconazole (Nitrate)……..1% w/w As per PRC/- Ointment manufacturing
Diflucortolone (Valerate)…. 0.1% 10gm & General (No. F. requirements
w/w 20gm 4.13- 4-2/2005-Lic for steroidal
06-2012 dated preparations.
Dy.No.1024 20/06/2008).
Rs.8000/- Inspection
(Original) report dated
31-7-2013 11/10/2011
Rs.52,000/- provided.
Now the firm has submitted the extract taken from the 239th Meeting of Central Licensing
Board held on Thursday, 22nd January, 2015 in which the said Board decided for steroidal topical
preparations like eye/ear drops, sterile eye ointment, external preparations i.e.
cream/ointment/Gel, Lotions, Spray/aerosols, suppositories, vaginal preparations, intra oral
preparations, Nasal drops etc shall be manufactured in general facility/area subject to following
conditions that the:-
a. Manufacturers shall have segregated dispensing booths, cleaning validation and
controls studies for processes and adequate system to minimize the potential risk of
cross contamination,
b. Commercial marketing of above products shall be allowed by Registration Board
after confirmation and verification of conditions as in (1.a) above.
Registration Board in its 275th meeting deferred the case for clarification from M/s Akhai
Pharmaceuticals (Pvt) Limited regarding confirmation of separate dispensing booth for such
products.
The firm has provided copy of inspection report conducted on 15-03-2018 by area FID
and he has reported that the firm has two separate/dedicated dispensing booths. Booth No.1 is
dedicated for dispensing of general products and booth No. 2 is dedicated for dispensing of
steroidal products of cream / ointment/gel and lotion to avoid cross contamination.
They have requested to issue the registration letter of above products.
Decision: Registration Board registered the products mentioned at Sr.no. 1 and 2 of the
above table in the name of M/s Akhai Pharmaceuticals, Baluchistan.
Case No.8 Change of Registration status of Drug(s) by M/s. Wyeth Pakistan, Karachi.
M/s Wyeth Pakistan, Karachi have applied for change of registration of their
product from Finished Import to bulk import and local repackaging from their old DSL to new
DSL with permission for contract manufacturing from M/s Pfizer Pakistan Limited, B-2, S.I.T.E,
Karachi (DML No. 000025).
S. Reg. Name of Drug and Initial Date of Existing Applied for change of
No No. Composition Reg. approval registration status.
Renewal Status status.
1 031368 Efexor XR Capsule 22-07-2007 The product Now the firm has requested for
150mg 1st renewal 24- was registration in the name of
Each capsule contains:- 07-2009 registered in M/s. Wyeth Pakistan Limited
Venlafaxine 2nd renewal 25- finished (DSL) Room No. 002 & 003,
Hydrochloride 06-2014 import. PGS Admin Block, First Floor,
169.7mg equivalent to Plot No. B-2 S.I.T.E Karachi
150mg Venlafaxine (DSL not attached) and bulk
base import from M/s. Pfizer
Ireland Pharmaceuticals Little
(Fee deposited Rs. Connell, Newbridge, Co.
65,000/-). Kildare, Ireland and local
repacking and release site is
M/s. Pfizer Pakistan Limited
B-2, S.I.T.E, Karachi-Pakistan.
2. 023658 Efexor XR Capsule 24-06-1999 Bulk import -do-
75mg Transfer of local repack
Each capsule contains:- registration dated
Venlafaxine 25-09-200
Hydrochloride Change of
169.7mg equivalent to manufacturing
75mg Venlafaxine base site dated
26.3.2002
(Fee deposted Rs. Renewal
60,000/-). application dated
03-04-2017
3. 014624 Tazocin EF 4.5gm 01-11-1993 The product The firm has requested to
Injection Transfer of was change the registration status
Each vial contains:- registration dated registered in in the name of M/s. Wyeth
Piperacilin Sodium 29-03-2008 bulk import Pakistan Limited (DSL) Room
……… 4gm Renewal and local No. 002 & 003, PGS Admin
Tazobactum Sodium ... application dated repacking Block, First Floor, Plot No. B-
500mg 26-04-2016 by M/s. 2 S.I.T.E Karachi.(DSL not
(Fee deposted Rs. Wyeth attached)
65,000/-). Pakistan Manufacturer:
Limited S- M/s. Wyeth Lederle S.r.I., Via
33, Hawks Franco Gorgone Zona
bay Road, Industrial Catania (CT) 95100-
S.I.T.E, Italy.
Karachi Release & packaging site:
(DML No. M/s. Pfizer Pakistan Limited
000006) B-2 S.I.T.E., Karachi.
Manufactur
ed by M/s.
Wyeth
Lederle
S.P.A Via
Franco
Gorgone
Zona
Industrial
Catania
(CT)
95100-Italy.
4. 045642 Tygacil Injection 30-05-2007 The product The firm has requested to
Each vial contains:- Renewal was change registration in the
Tigecycline ….. 50mg application dated registered in name of M/s. Wyeth Pakistan
25-02-2013 finished Limited (DSL) Room No. 002
(Fee deposted Rs. import in & 003, PGS Admin Block,
10,000/-). the name of First Floor, Plot No. B-2
M/s. Wyeth S.I.T.E Karachi.(DSL not
Pakistan attached). The manufactur will
Limited S- be remains as approved earlier.
33, Hawks
bay Road,
S.I.T.E,
Karachi
(DML No.
000006)
5. 039594 Premarin 0.3mg Tablet 04-10-2005 The product Relates to Biological Division
Conjugated Estrogens Renewal of drug was and we may refer the case to
USP (Desiccated with registration dated registered Biological Division.
Lactose at 4.29%) 28-4-2017 and for bulk
………….. 0.3mg the registration is import local
(Fee deposted Rs. valid till 03-10- repacking
60,000/-). 2020 by M/s.
Wyeth
Pakistan
Limited,
6. 001547 Incremin Syrup 15-08-1976 The product The firm has requested to
Each 5ml contains:- Transfer of was change the registration status
L-Lysine regsitartion dated registered in in the of M/s. Pfizer Pakistan
Monohydrochloride 07-05-2007 the name of Limited B-2 S.I.T.E., Karachi
………… 300mg Renewal M/s. Wyeth (DML.No.000025)
Pyridoxine HCl… 5mg application Pakistan
Thiamine HCl …10mg applied on 05- Limited S-
Vitamin B12 05-2017 33, Hawks
Cynacobalamine bay Road,
Crystalline …. 25mg S.I.T.E,
Ferric Pyrophosphate Karachi
…. 30mg (DML No.
(equivalent to 000006).
elemental iron 30mg)
(Fee deposted Rs.
20,000/-).
008553 Stresstabs 600 with 17-11-1985 The product The firm has requested to
Zinc Transfer of was change the registration status
Each tablet contains:- regsitartion dated registered in in the of M/s. Pfizer Pakistan
Biotin Triturate 1% 07-05-2007 the name of Limited B-2 S.I.T.E., Karachi
….. 45mcg Renewal M/s. Wyeth (DML.No.000025)
Vitamin B12 …12mcg application Pakistan
Folic Acid ……0.4mg applied on 05- Limited S-
D-Calcium 05-2017 33, Hawks
Pantothenate .. 25mg bay Road,
DI-Alpha Tocopheryl S.I.T.E,
Acetate 500….. 30I.U Karachi
Cupric Oride-Reagenct (DML No.
(79.88%) ……. 3mg 000006).
Pyridoxine HCl …5mg
Ascorbic Acid..300mg
Riboflavin ……10mg
Zinc Sulphate
(Monohydrate).23.9mg
Thiamine Mononitrate
…… 20mg
Niacinamide Ascorbate
(25%) ……. 100mg
Niacinamide Ascorbic
Acid (75%)…. 100mg
Vitamin C
(Fee deposited
Rs.20,000/-).
Accordingly, firm has submitted following documents:
1. Request with Form 5 and Fee of 65,000/-
2. Copies of initial letter of registrations.
It is submitted that for change of registration status of above mentioned products for import, the
firm has submitted acknowledgement receipts for Drug Sale License from Health department
Government of Sindh. Accordingly, it is proposed that
a. For products at Sr.No. 1-4, copy of Drug Sale License is required.
b. For product at Sr.No. 5, application dossier is related to Biological Division.
c. For products 3, 4, 6 & 7, confirmation of renewal status is required by RRR section.
d. For products at Sr.No. 1-4, remaining fee is required.
Decision: Registration Board deferred the case for submission of Drug Sales License of M/s
Wyeth Pakistan, Karachi. Meanwhile, reference will be sent to RRR section for
confirmation of renewal status.
Case No.9 Change in title and management of M/s. Pfizer Pakistan Limited B-2 S.I.T.E
Karachi
M/s. Pfizer Pakistan Limited B-2 S.I.T.E Karachi has requested for change of title
of the firm from M/s. Park Davis B-2 S.I.T.E, Karachi to M/s. Pfizer Pakistan Limited B-2 S.I.T.E
Karachi dated 07th September, 2010. However, due to illegible appearance of the address of
manufacturing site, a reference was sent to Licensing Division for clarification. The firm applied
for change of registration status on the basis of change of name of firm. However, vide letter
No.F.2-2/89-Lic (Vol-I) dated 18-12-2017 Licensing Division has informed about change of
management of M/s Pfizer Ltd., Karachi (DML N0. 000025). Initially, the firm applied for change
of registration status of 20 products, however, RRR has informed about renewal status of
following 15 products and others are in process.
Sr.# Reg. Name (s) & Formulation Initial Date Remarks of RRR
No. of Reg.
1. 061330 Pfiziflox Tablets 250mg 17.04.2010 Renewal applications are received
Each tablet contains:- within time but the name of M/s
Levofloxacin as Hemihydrate… Pfizer Pakistan Limited Karachi,
250 mg while the products are yet not
transferred to their new title
2. 061331 Pfiziflox Tablets 500mg 17.04.2010 -do-
Each tablet contains:-
Levofloxacin as Hemihydrate
…500 mg
3. 061965 Gliride Tablets 1mg 15-09- -do-
Each tablet contains:- 2010
Glimepiride…. 1 mg
7. 061969 Savoxacin Tablets 250mg 15-09- -do-
Ciprofloxacin HCl… 250 mg
8. 061970 Savoxacin Tablets 500mg 15-09- -do-
Ciprofloxacin HCl… 500 mg
9. 061651 Antamol Tablets 20/120mg 07-07- -do-
Artemether… 20mg
Lumefantrine… 120mg
10. 061408 Controbeat Tablets 25mg 13-05- -do-
Atenolol… 25 mg
Atenolol… 50 mg
Atenolol…. 100 mg
13. 061334 Bronsecur Chewable Tablets 4mg 27-04- -do-
Each chewable tablet contains:- 2010
Montelukast as sodium…4mg
14. 061335 Bronsecur Tablets 5mg 27-04- -do-
Montelukast as sodium….5mg
15. 061336 Bronsecur Tablets 10mg 27-04- -do-
Montelukast as sodium…10mg
Firm has submitted that it is a post marketing variation (Change in name of manufacturing site)
and therefore, provided following documents:
 Application on Form-5
 Fee of Rs. 5,000/- for each product
 Initial Registration Letter, Renewal status
 NOC for CRF Clearance
 Approval of new name/title from CLB
 Undertaking that formulation, API source and specification, manufacturing process,
analytical test methods, and release and shelf life specifications have not changed.
“The Registration Board deferred the case in its 277th meeting for submission of requisite
fee. The firm has submitted original challan of fee of Rs. 15,000/- per product and
requested to approve their request.”
Decision: Registration Board approved the change of registration status of the products
mentioned at Sr.no. 01 – 15 in the new title of the firm i.e. M/s Pfizer Ltd.,
Karachi, B-2 S.I.T.E., Karachi (DML N0. 000025).
Case No.10 Change of Title of Company of M/s. Brookes Pharma (Private) Limited,
Karachi.
M/s. Brookes Pharma (Private) Limited 58 & 59, Sector 15, Korangi Industrial Area,
Karachi has requested for change of registration of status of following products as transfer the
registration of following products from their previous name of the firm i.e M/s. Brookes
Pharmaceutical Laboratories (Pakistan) Limited, Karachi to their new name of their company i.e
M/s. Brookes Pharma (Private) Limited 58 & 59, Sector 15, Korangi at same facility. The cae was
referred to RRR section for clarification of renewal status as decision of the PRVC in its 3rd
meeting and RRR section has responded as under:-
S.No. Name of Drug(s) with composition Renewal status provided by RRR
Reg. No
section.
1. Ponsac Forte Tablets Registration Board decided to grant /
025498
Each tablet contains: regularize the renewal till 28-09-2018.
Mefenamic Acid ….…. 500.00 mg
2. Ponsac Suspension 025499 -do-
Each 5ml contains:
Mefenamic Acid ...…. 50.00 mg
3. Haltrin 200 mg Tablet Registration Board decided to grant /
061068
Each film coated tablet Contains: regularize the renewal till 15-11-2018.
Dexibuprofen …….. 200.00 mg
4. Haltrin 400 mg Tablet -do-
061069
Each film coated tablet Contains:
Dexibuprofen .…….. 400.00 mg
The firm provided original challan of fee of Rs. 20,000/- for each product and application on Form-5.
Decision: Registration Board approved the change of registration status of the products
mentioned at Sr.no. 01 – 04 in the new title of the firm i.e. M/s. Brookes
Pharma (Private) Limited 58 & 59, Sector 15, Korangi, Karachi.
Case No.11 Change of Registration Status of Drug(s) of M/s ICI Pakistan Ltd, Karachi.
M/s ICI Pakistan Ltd S-33, Hawkes Bay Road, S.I.T.E Karachi has requested for
change of Registration status of following products from M/s. Pfizer Pakistan Ltd Karachi & M/s.
Wyeth Pakistan Limited, Karachi to their of the firm as per following details.
S. Reg. Name of Drug Registration Status Remarks
No. Number
1 00 3477 Combantrin Tablet 250mg I- Initial Registration Date= 04- The product is
Each tablets contains June-1978 applied through
pyrantel pamoate… 250mg II- Transfer of Registration Date contract
is 1-June-2011 manufacturing by
III- Renewal of Registration date M/s Pfizer Pakistan
is 24-May-2016 Ltd Karachi
2 000 141 Citralka Liquid I- Initial Registration Date= 24- The product is
Each 5ml contains: April- year is not visible applied through
Disodium hydrogen citrate II- Transfer of Registration Date contract
B.P.………1.315g is 1-June-2011 manufacturing by
III- Renewal of Registration M/s Pfizer Pakistan
Date is 24-May-2016 Ltd Karachi
3 0 10015 Wymox Capsules 250mg I- Initial Registration letter date The firm has
Each capsule contains: is 13-Nov-1988 applied for change
Amoxicillin (as Trihydrate) II- The product is valid till 30-6- of contract
USP…. 250 mg 2020. manufacture from
Macter
International Pct
Ltd, Karachi to
Cirin Pharma Pvt
Ltd, Hattar.
4 0 10016 Wymox Capsules 500mg I- Initial Registration letter date
Each capsule contains: is 13-Nov-1988
Amoxicillin (as Trihydrate) II- The product is valid till 30- -do-
USP…. 500 mg 06-2020.
5 0 13747 Wymox Injection 250mg I- Initial Registration letter date
Each vial contains: is 17-Nov-1992
Amoxicillin sodium equivalent II- The product is valid till 30-
to 250 mg amoxicillin 06-2020.
6 0 13748 Wymox Injection 500mg I- Initial Registration letter date
Each vial contains: is 17-Nov-1992
Amoxicillin sodium equivalent II- The product is valid till 30- -do-
to 250 mg amoxicillin 06-2020.
7 0 10017 Wymox Suspension 125mg/5ml I- Initial Registration letter date
Each 5ml contains: is 13-Nov-1988
Amoxicillin (as Trihydrate) II- The product is valid till 30- -do-
USP…. 125 mg 06-2020.
8 0 12816 Wymox Suspension 250mg/5ml I- Initial Registration letter date Registration
Each 5ml contains: is 05-May-1990 Number of product
Amoxicillin (as Trihydrate) II- The product is valid till 30- needs clarification.
USP…. 250 mg 06-2020.
9 00 7119 Lederrif Tablet 600mg I- Initial Registration letter date Firm has requested
Each tablet contains: is 27-March-1984 to change the
Rifampicin USP…… 600 mg II- Transfer of Registration date registration status
is 17-August-2010 from M/s. Wyeth
III- Renewal of Registration Pakistan Limited,
date is 7-August-2015 S-33, Hawksbay
Road, S.I.T.E, to
M/s. ICI Pakistan
Ltd, Karachi.
10 00 9970 Lederrif Susp 100mg/5mL I- Initial Registration letter date
Each 5 mL contains: is 25-September-1988
Rifampicin USP…… 100 mg II- Transfer of Registration date -do-
is 17-August-2010
III- Renewal of Registration
date is 7-August-2015
11 00 6914 Lederrif Tablet 300mg I- Initial Registration letter date
Each tablet contains: is 15-August-1983
Rifampicin USP… 300 mg II- Transfer of Registration date -do-
is 17-August-2010
12 00 6915 Lederrif Tablet 450mg I- Initial Registration letter date
Each tablet contains: is 22-January-1984
Rifampicin USP…… 450 mg II- Transfer of Registration date -do-
is 17-August-2010
13 00 9969 Lederrif INH Tablets I- Initial Registration letter date
Each tablet contains: is 25-September-1988
Rifampicin USP…… 300 mg -do-
Isoniazid USP……... 150 mg
14 000 102 Lederplex Liquid I- Initial Registration letter date
Each 4 mL contains: is 22-March-1976
Vitamin-B1……...2mg II- Transfer of Registration date -do-
Vitamin B2………...2mg is 07-May-2007
Vitamin B6……...0.2mg
Vitamin B12…….5mcg
Niacinamide………10mg
Calcium Pantothinic Acid.2mg
Choline………….20mg
Insitol…………..10mg
15 00 8998 Entox-P Tablet 500mg I- Transfer of Registration date
Each tablet contains: is 06-March-2008
Activated attapulgite B.P.… 500 -do-
mg
16 00 1554 Nilstat Drops 100,000 units/mL I- Initial Registration letter date
Each ml contains: is 15-August-1976
Nystatin USP…. 100,000 units II- Transfer of Registration date -do-
is 7-May-2007
17 00 1555 Nilstat Ointment 100,000 I- Initial Registration letter date

units/g is 15-August-1976
Each gm contains: II- Transfer of Registration date -do-
Nystatin USP. 100,000 units is 7-May-2007
18 00 1553 Nilstat Tablets 500,000units/ tab I- Initial Registration letter date
Nystatin USP. 500,000 units II- Transfer of Registration date -do-
is 7-May-2007
19 00 1556 Nilstat V Tablet 100,000 nits/tab I- Initial Registration letter date
Nystatin USP... 100,000 units II- Transfer of Registration date -do-
is 7-May-2007
20 0000 86 Mucaine Suspension I- Initial Registration letter date
Each 5ml contains: is 22-March-1976
Oxethazaine…… 10 mg II- Renewal of Registration date -do-
Aluminum hydroxide USP is 16-Nov-2007
.............291mg
Magnesium hydroxide USP
.........……98mg
21 0000 88 Mucaine Tablets I- Initial Registration letter date
Each tablet contains: is 22-March-1976
Oxethazaine……….. 5 mg II- Renewal of Registration date -do-
Aluminum hydroxide gel USP is 16-Nov-2007
…165mg
Magnesium carbonate USP …
83.8mg
22 00 7264 Tri-Hemic 600 Tablet I- Initial Registration letter date
Each tablet contains: is 17-Nov-1985
Ascorbic Acid……...600mg II- Transfer of Registration date -do-
Cyanocobalamin….25mcg is 7-May-2007
Ferrous Fumarate..350mg
Folic Acid………...1mg
Tocopherol (Vitamin E)..30IU
The renewal status of products at Sr. No. 1 & 2 is not yet clarified from RRR section and renewal
of the rest products has been clarified from RRR Section. The firm has provided From-5 and fee
for this purpose.
 Deferred product at Sr.no. 01 and 02 for confirmation of renewal
status and evidence of approval status in reference regulatory
authorities for product at Sr.no.02, 15 and 21.
 Approved registration of products at Sr.no. 3-14, 16-20 and 22 in the
name of M/s ICI Pakistan Ltd S-33, Hawkes Bay Road, S.I.T.E.
 For products at Sr.no. 03-08, Board granted permission for contract
manufacturing of the products from M/s Cirin Pharma Hattar under
Rule 20A of Drugs (Licensing, Registering and Advertising) Rules,
1976. This approval is granted till 30-06-2020.
Case No. 12 Request for contract manufacturing of drug by M/s. Tabros Pharma (Pvt.)
Ltd; Karachi.
M/s. Tabros Phamra (Pvt.) Ltd; Karachi was granted the registration of following product:-
Reg.No. Name of Drug(s) Registration History Remarks
026886 Biflor Sachet 250mg Init. Date of Reg. 12-05-2001 Renewal
Each sachet contains:- Copy of 1st renewal application dated 04-2-2006 confirmation
Lyophilised Saccharomyces Cop of 2nd renewal application dated 14-4-2011 required from
boulardil ………. 285mg Copy of 03rd renewal dated 18-02-2016 RRR section.
(Corresponding to 250mg of
Yeast)
The management of the firm has provided following documents:-
i. Fee of Rs. 50,000/- for this purpose.
ii. Copy of renewal of registration and copies of renewal applications.
iii. Contract agreement on stamp paper.
iv. Last inspection of M/s. Hilton Pharma, Karachi dated 19-07-2017.
v. Approval of Section by CLB of M/s. Hilton Pharma, Karachi.
vi. NOC from M/s. Hilton Pharma, Karachi.
M/s. Tabros Pharma, Karachi has requested to change the registration status of above
product to contract manufacturing by M/s. Hilton Pharma (Pvt.) Ltd; Plot 13-14, Sector 15,
Korangi Industrial Area, Karachi. The firm has further stated that they are planning to establish
Probiotics facility.
M/s Hilton Pharma, Karachi was granted Sachet (Enflor) Section on 4.12.2014 with following
remarks:
“The Central Licensing Board has granted provisional approval of
amendments/expansion in already existing sachet (Enflor) section. The active ingredient of
sachet Enflor is Sacharomyces Boulardii is probiotic which is not a drug after the
promulgation of DRAP Act, 2012. Since the firm has registration of Enflor sachet product,
therefore the Board directed to refer the cae to Division of Pharmaceutical Evaluation &
Research, DRAP, Islamabad to take review of registration of probiotic (Sachet Enflor)
product of the firm and to inform CLB for necessary action accordingly”.
Registration Board in its 278th meeting referred the matter to Licensing Division for
evaluation in light of decision of DRAP‘s authority in the subject matter.
The Licensing Division vide their letter No.F.2-14/85-Lic(Vol-V) dated 11-04-2018
informed that the approval of sachet (Probiotic) section in partial modification of M/s. Hilton
Pharma, Karachi under DML No. 000136. Furthermore, Secretary has requested that Registration
Board may decide the matter in the light of decision of DRAP Policy Board.
Decision: Registration Board deliberated on the matter in the light of approval of sachet
(Probiotic) section granted by CLB to M/s Hilton Pharma, Karachi. The
Board granted permission of contract manufacturing of Biflor Sachet 250mg
( Reg.No. 026886) of M/s Tabros Pharma, Karachi from M/s Hilton Pharma
Karachi under Rule 20A of Drugs (Licensing, Registering and Advertising)
Rules, 1976. This approval will remain valid for a period of 5 years from the
date of issuance.
Case No. 13 Correction in Pack size of Product.
Following product of M/s Brookes Pharmaceuticals Labs, Karachi was approved in 268 th
S.No Name of Drug(s) & Composition Pack size Decision of Registration Board
1 Tomex Injection 4.2x2ml Registration Board decided to approve
Each ml contains:- registration of Tomex (Dexmedetomidine
Dexmedetomidine (as HCl) … 100 mcg 100 mcg/ml as Hydrochloride) Injection 2
USP Specification ml by M/s Brookes Pharmaceutical Labs
Karachi. Manufacturer will place first
three production batches on long term
stability studies through proposed shelf
life and on accelerated studies for six
months.
The MRP of the above mentioned product was approved in 25th DPC dated 21st February,
2018 for pack size of 2x2ml. However, during processing of registration letter it was noted that
the demanded Pack size by the firm was mentioned in 245th meeting of Registration Board as
4.2x2ml. Furthermore, firm submitted the undertaking that ―they applied for their novel product
with pack size of 2x2ml.”
Accordingly, Chairman Registration Board approved the issuance of registration letter with
correct pack size of 2x2ml as approved in 25th DPC. Submitted for information of Registration
Board
Decision: Registration Board endorsed correction in the pack size of Tomex Injection
already approved/issued in the name of M/s Brookes Pharma, Karachi.
E. Registration-III Section
Case No.14 Change of registration status from M/s Welwrd Pharmaceuticals, Hattar to
M/s Walt Danzay Pharmaceutical, Taxila.
M/s Walt Danzay Pharmaceuticals Pharmaceutical, Plot No. 35-A Small Industrial
Estate, Taxila have requested for transfer of following already registered products from the name
of M/s Welwrd Pharmaceuticals, Plot # 3, Block-A, Phase I-II, Industrial Estate, Hattar to their
name.
S.# Reg. Brand Name with Initial Registration Dy. No. and Status in
No. Generic Letter Date and date reference drug
Renewal Status agencies & Me-
too
1. 049374 NBF Injection 12-07-2008 410 DDC R-III  USFDA
Each ml contains: Renewal due: 22-02-2018 approved
Nalbuphine 11-07-2013  Kinz
hydrochloride….10mg Renewal applied: 15-
02-2013
10mg/ml
Change of brand Injection by
name from Nalbowin M/s Sami
to NBF : 18-10-2017
2. 040341 Somaline Injection 11-06-2005 411 DDC R-III  ANSM
Each 2ml contains: Renewal due: 22-02-2018 Approved
Citicoline as 10-06-2015
 CT-Nol of
sodium….250mg Renewal applied: 29-
01-2015 M/s Uni-
Change of brand Tiech
name from Pharmaceutia
Welcoline to ls,
Somaline : 12-10- (Reg.#04704
2009
9)
3. 076811 Lecoject Injection 08-04-2013 412 DDC R-III  ANSM
Each ml contains: Renewal due: 22-02-2018 Approved
Cholecalciferol ….5mg 07-04-2018
(200,000 IU) Change of brand
 Get D
name from Wrd-D to injection of
Lecoject: 18-10-2017 M/s Getz
Renewal not Pharma
required.
In support to the request the firm has provided following documents:

i) Application with prescribed fee amounting to Rs.50,000/- for each product.
ii) Initial Registration Letters and renewal status.
iii) NOC dated 02-04-2018 from M/s Welwrd Pharmaceuticals, Hattar.
iv) Latest inspection report of M/s Walt Danzay Pharmaceuticals dated 15-02-2017 for
the grant of DML.
v) Section approval letter of M/s Walt Danzay Pharmaceuticals (Liquid Injection
Ampoule General Section confirmed)
vi) DML of M/s Walt Danzay Pharmaceuticals dated 24-04-2017 and M/s Welwrd
Pharmaceuticals dated 20-05-2015.
Decision: Registration Board deferred the request of the firm for:
i) Submission of latest GMP inspection report of M/s Walt Danzay
Pharmaceutical, Taxila which should be conducted within last one
year.
ii) Verification of renewal status of the product at S. No. 2 from RRR
section.
Case No.15 Cancellation of registration of drugs of M/s Everest Pharmaceuticals,

Islamabad.
The letter for cancellation of registration of all drugs registered in the name of M/s
Everest Pharmaceuticals, Islamabad has been dispatched to the CEO of the firm via
superintendent of the jail. Superintendent of Central Prison Rawalpindi has informed that the said
letter has been served upon the under-trial prisoner Muhammad Usman s/o Zaheer Ahmed after
affixing his left hand impression and duly attested copy of this letter by the Deputy
Superintendent of the prison has been returned.
Decision: Registration Board noted the information for its record.
F. Registration-IV
Case No.16 Request of M/s. Zaynoon Pharmaceuticals, Peshawar For Grant of Afresh
Registration.
The Registration Board, in 276th meeting held on 22ND- 25TH November, 2017, declared
registration of all drugs of M/s. Zaynoon Pharmaceuticals, Peshawar invalid due to invalidity of
DML declared by CLB (vide 249th meeting). However, the firm was issued afresh DML No.
000358 by way of formulation, dated 11-04-2017. Management of the firm has now applied for
registration of following products on form-5 with fee of Rs.20,000/- each as per details mentioned
below:
S# Brand Name, Dy.No./Date & Evidence of Section Remarks
Composition and Demanded Availability in Approval,
(Reg.No) Price/ Pack RRAs and Me- Last
too Status Inspection
Provided by Report &
Firm DML
1. Fe-Fa Syrup Dy.No.370 Polyfer FA Approval of -
Each 5ml contains: - 11-04-2018 Syrup By M/s. Liquid Syrup
Iron (III) Hydroxide Barrett Hodgson, Section:
Polymaltose Complex eq. 20,000/- Karachi 13-04-2017
to Elemental Iron …5mg 10-04-2018 Last
Folic Acid….0.35mg Rs.80/60ml Inspection
Rs.140/120ml report:
Reg.No.016008 11-01-2018
DML:
11-04-2017
2. Farmide Syrup Dy.No.366 UK MHRA -do- -
Each 5ml contains: - 11-04-2018 approved.
Metoclopramide
HCl…5mg 20,000/- Maxolan Syrup by
10-04-2018 M/s. GSK Pakistan
Reg.No.017635 Rs.30/20ml
Rs.35/50ml
3. Peristal Suspension Dy.No.369 UK MHRA -do- -
Each 5ml contains: - 11-04-2018 approved.
Domperidone….5mg
20,000/- Motillium
Reg.No.031142 10-04-2018 Suspension by
Rs.40/60ml Jannsen Pakistan
Rs.80/120ml
4. Nafaflux-P Syrup Dy.No.368 Polyfer Syrup By -do- -
Each 5ml contains: - 11-04-2018 M/s. Barrett
Iron (III) Hydroxide Hodgson,
Polymaltose Complex eq. 20,000/- Karachi
to Elemental Iron…50mg 10-04-2018
Rs.80/60ml
Reg.No.040603 Rs.140/120ml
5. Zaygor Syrup Dy.No.365 UK MHRA -do- -
Each 10ml contains: - 11-04-2018 approved
Pizotifen as Hydrogen Sanomigran
Malate….0.5mg 20,000/- Elixir
10-04-2018
Reg.No.016427 Rs.60/60ml Mosegar Syrup
Rs.90/120ml by Novartis
Pharma.
6. Nafpol Suspension Dy.No.363 UK MHRA -do- -
Each 5ml contains: - 11-04-2018 Paracetamol
Paracetamol….120mg Suspension
Reg.No.016007 20,000/- 120mg/5ml
10-04-2018 Calpol
Rs.30/60ml Suspension by
Rs.44/100ml GSK Pakistan
7. Nafralin-DM Syrup Dy.No.364 UK MHRA -do- Previously

Each 5ml contains:- 11-04-2018 approved registered
Dextromethorphan Covonia Hot formulation
Hydrobromide……6.25mg 20,000/- Dose Cough and (Reg.No.016428):
Diphenhydramine 10-04-2018 Cold Syrup Each 5ml contains:-
HCl….5mg Rs.35/60ml Dextromethorphan
Rs.65/120ml Anti Cough DM Hydrobromide…..10
Syrup by M/s. mg
240ml Mediways Diphenhydramine
Lahore HCl….8mg
Approval status in
Reference
Regulatory
Authorities
couldn’t be
verified.
8. Zayrollin Syrup Dy.No.367 Hydryllin Syrup Approval status in
Each 5m contains: - 11-04-2018 by M/s Searle, Reference
Aminopylline…..32mg Pakistan Regulatory
Diphenhydramine 20,000/- Authorities couldn’t
HCl….8mg 10-04-2018 be verified.
Ammonium Rs.35/60ml
Chloride…30mg Rs.55/120ml
Manthol…0.98mg
240ml
(Reg.No.016429)
Conclusion of GMP Inspection Report: -

―Overall the cGMP Compliance is not satisfactory and the firm is directed to prepare a
plan for the rectification all the deficiencies noted by them at their earliest. They are further
directed to immediately stop the use of old bottles and do not manufacture any product using 2nd
hand bottles.
The above points discussed with management and they agreed to rectify at their earliest.‖
Decision: Registration Board decided as under:
i. Approved the grant of registration for products at S.No. 1,3,4 and 5
with “As per Innovator’s Specifications”.
ii. Approved the grant of registration for product at S.No.2 and 6 with
“USP Specifications”.
iii. Deferred the products at S.No. 8 and 9 for submission of evidence of
approval status in Reference Regulatory Authorities.
Case No.17 Correction in Specifications of Registered Products
Following firms applied for various post registration variations with respect to their below
mentioned registered products. During evaluation it was noted that corrections are required in
specification of these products. The details are as under:
S. Name of Regn. Brand Name with Composition & Brand Name with Composition
# Firm No. existing Specifications & Correct Specification
1. M/s 080401 Wingab 75 Capsule Wingab 75 Capsule
WnsFeild Each capsule Contains: Each capsule Contains:
, Hattar Pregabalin …75 mg Pregabalin …75 mg
(Wnsfeild Specifications) (As per *Innovator’s
Specifications)
2. -do- 077437 Desloreal 5 mg Dispersible Tablets Desloreal 5 mg Dispersible
Each dispersible tablet contains:- Tablets
Desloratadine..5 mg Each dispersible tablet contains:
(Wnsfeild Specification) Desloratadine..5 mg
(As per *Innovator’s
Specifications)
3. -do- 075587 Delta D-3 5 mg Injection Delta D-3 5 mg Injection
Each 1 ml ampoule contains:- Each 1 ml ampoule contains:-
Cholecalciferol 200,000 I.U. Cholecalciferol 200,000 I.U.
≡ Cholecalciferol.5mg ≡ Cholecalciferol.5mg
(USP Specification) (BP Specifications)
4. M/s Cirin 046985 Novocef Injection. Novocef Injection.
Pharmace Each vial contains:- Each vial contains:-
uticals, Cefoperazone Sodium USP eq. to Cefoperazone Sodium USP eq.
Hattar Cefoperazone..1000mg to Cefoperazone..1000mg
Sulbactam Sodium USP eq. to Sulbactam Sodium USP eq. to
Sulbactam…..1000mg Sulbactam…..1000mg
(USP) (JP Specification)
5. -do- 045911 Novocef Injection. Novocef Injection.
Each vial contains:- Each vial contains:-
Cefoperazone (as Sodium) Cefoperazone (as Sodium)
USP…500mg. USP…500mg.
Sulbactam Sodium Sulbactam Sodium
J.P……………500mg. J.P……………500mg.
(JP Specification)
6. M/s 073203 Trimether Injection Trimether Injection
Treat, Each ml contains:- Each ml contains:-
Bannu Artemether……….80mg Artemether……….80mg
(Treat Specification) (International Pharmacopeial
Specification)
7. M/s 064303 Sydimalt Syrup Sydimalt Syrup
Sayyad Each 5ml contains:- Each 5ml contains:-
Pharmace Iron Polysaccharide complex Iron Polysaccharide complex
uticals, equivalent to Iron (III)……100mg equivalent to Iron
Hattar (Sayyed Specification) (III)……100mg
(As per *Innovator’s
Specifications)
8. M/s 044741 Fexofax Tablets 60mg Fexofax Tablets 60mg

Alliance Each Tablet Contains:- Each Tablet Contains:-
Pharmace Fexofenadine…………60mg Fexofenadine…………60mg
uticals, (USP Specification)
Peshawar
The matter of change of name/ correction in brand name is being considered by the post
registration variations committee. However, for required correction of specifications, as
mentioned against each product, the matter is submitted for consideration of the Registration
Board.
Decision: Registration Board approved the correction in finished products specifications
of products at S.No.1-8 of above table as per details mentioned in the last
column. The Board further advised that the formulation at S.No.7 shall be
standardized to Iron (III) Hydroxide Polysaccharide complex equivalent to
Elemental Iron……100mg
Case No.18 Resemblance of Brand Name of Registered Products of M/s. Hicon

M/s Asian Continental, Karachi had requested for change of brand names of following
products of M/s Hicon Pharmceuticals, Peshawar due to resemblance. Details are as under:
S. Regn. No. Existing Name & Initial Justification

# Composition of M/s registration
Hicon with renewal
Pharmaceuticals, Status
Peshawar
I II III IV V
1 041496 Loren Tablets Oct,2005 Due to resemblance with Lorin NSA Tablet
Each Tablet contains: (Reg.No.020169) of M/s Asian Continental,
Loratidine ….. 10mg Karachi, dated. 05-12-1998 (as per letter for
change of brand name issued to the earlier
registration holder i.e M/s Platinum,
Karachi)
2 041522 Loren Suspension -do- Due to resemblance with Lorin NSA
Each 5ml contains: Syrup(Reg.No.021619) of M/s Asian
Loratidine …… 5mg Continental, Karachi, dated. 05-12-1998
Accordingly, M/s Hicon Pharmceuticals, Peshawar was directed, vide letters dated 16-
06-2014, 26-04-2017 and 14-07-2017, to propose alternate brand names along with
documents/information requisite for change of brand name (as per SOP).
The firm i.e M/s Hicon, Peshawar has responded vide letters dated 25-06-2014, 18-07-
2017 and 20-09-2017 by providing alternate brand names. However, provided brand names also
resemble. Furthermore, information/ documents required as per SOP have not been submitted
yet.
M/s Asian Continental, Karachi has once again highlighted the issue stating that M/s
Hicon, Peshawar has marketed fresh stock of Loren Syrup with Batch No.4226 and shelf life
01-2018 to12-2019.
Decision: Registration Board decided to issue show cause notice to M/s Hicon
Case No.19 Registration of Drugs of M/s. Cherwel Pharmaceutical (Pvt) Ltd, Hattar for
Export purpose.
M/s Cherwel Pharmaceuticals (Pvt) Ltd., Hattar has applied for registration of drug,
exclusively for export purpose as per following details.
F-S-Fol Tablet
Each film coated tablet contains:

Ferrous Sulphate…....60mg
Folic Acid………….0.4mg
Details of documents submitted by the firm:

i. Application on Form 5D.
ii. Fee of Rs. 50,000/-
iii. NOC for CRF valid upto 31-12-2018.
iv. Approval of relevant section verified from panel inspection report dated 27-09-2014.
v. Last GMP inspection report dated 17-03-2017.
vi. Undertaking for export purpose on stamp paper.
vii. National Licensed Medicine List of Afghanistan including Ferrous Sulfate 60mg +
Folic acid 0.4mg Tablet as evidence of availability in importing country.
Decision: Registration Board approved grant of registration to F-S-Fol Tablet,

exclusively for export purpose. Manufacturer will comply following conditions
before export of drug:
i. Manufacturer will export the product after complying all the
requirements as required under Drug Act, 1976 and relevant rules
including No Objection Certificate from concerned DRAP office.
ii. Manufacturer will also furnish export documents endorsed from
custom authorities (if required for any query) in order to ensure
the export of the product.
G. Registration –V
Case No.20 Transfer of Registration from M/s. Wnsfeild Pharmaceuticals, Hattar to

M/s. Wellness Pharmaceuticals (Pvt) Ltd, Lahore
M/s. Wellness Pharmaceuticals (Pvt) Ltd, Lahore has requested for transfer of following
registered products of M/s. Wnsfeild Pharmaceuticals, Hattar to their name :-
Sr. No Reg. No Name of product & formulation Remarks

1. 083140 Ridomide 50mg Tablet Renewal valid (brand name
Each film coated tablet contains:- changed dated 18th oct, 2017)
Lacosamide…………………….50mg USFDA approved
2. 083142 Ridomide DS 100mg Tablet Renewal valid (brand name
Lacosamide…………………….100mg USFDA approved
3. 084220 Profitam 250mg Tablet Renewal valid (brand name
Levetiracetam………………….250mg
(USP Specification) USFDA approved
4. 084221 Profitam 500mg Tablet Renewal valid (brand name
Levetiracetam………………….500mg
5. 084227 Delpoflex 4mg tablet Renewal valid (brand name
Each tablet contains:- changed dated 18th oct, 2017)
Tizanidine as HCl…………………..4mg
6. 064337 Endtron Injection Last Renewal dated 31 july,
Each 4ml contains:- 2015.
Ondansetron (as HCl)…………8mg
(USP Specification) MHRA approved
7. 064338 Respivant 1mg Tablet Last Renewal dated 31 july,
Each tablet contains:- 2015.
Risperidone…………………….1mg Firm demanded brand name
(USP Specification) Mytodone
USFDA approved
8. 064339 Respivant 2mg Tablet Last Renewal dated 31 july,
Risperidone…………………….2mg Firm demanded brand name
(USP Specification) Mytodone
USFDA approved
9. 064340 Moxofin 400mg Tablet Last Renewal dated 31 july,
Moxifloxacin (as HCL)…………….50mg Firm demanded brand name
Moxofin
USFDA approved
10. 080877 Moxofin 400mg Infusion Renewal valid (brand name
Each 250ml vial contains:- changed dated 18th oct, 2017)
Moxifloxacin HCl eq to:- Firm demanded brand name
Moxifloxacin………………..400mg Moxofin
USFDA approved
11. 087031 Mytodone 4mg Tablet Renewal valid.
Each film coated tablet contains:- USFDA approved
Risperidone…………………….4mg
(USP Specification)
12. 046813 Delpoflex Tablet Renewal valid (brand name
Each tablet contains:- changed dated 18th oct, 2017)
Tizanidine as HCl………………..2mg USFDA approved
13. 060052 Lewdes 5mg tablet Last renewal dated 22nd July,
Desloratadine……………………..5mg USFDA approved
14. 075596 Endtron 8mg tablet Last renewal dated
Each tablet contains:- 28.03.2018.
Ondansetron (as HCl dihydrate) ….8mg
15. 075577 Zolfenac 50mg tablet Last renewal dated
Each coated tablet contains:- 16.03.2018
Diclofenac Sodium………………..50mg
Misoprostol…………………………200 µg USFDA approved
(USP specification) formulation is delayed
release
16. 080244 Olaway tablet 8mg Renewal valid (brand name
Lornoxicam………………………..8mg
USFDA approved
Transfer of registeration of above mentioned products are subject to contract manufacturing:
 M/s wellness pharmaceutical, Lahore (contract giver)
 M/s wnsfeild pharmaceuticals, Hattar (contract acceptor).
The firm has submitted following documents.

i. Application with fee of Rs.50000/- for each product for this purpose.
ii. Form-5.
iii. Agreement for Transfer of Registration subject to Toll manufacturing
(dated 13th Feb, 2018)
iv. Agreement for contract manufacturing (dated 05.04.2018) between M/s
wellness pharmaceutical, Lahore (contract giver) and M/s wnsfeild
pharmaceuticals, Hattar (contract acceptor).
v. Copy of Registration letters with renewal status.
Decision: Registration Board deferred the request of M/s. Wellness Pharmaceuticals (Pvt)
Ltd, Lahore for confirmation of total number of sections and products already
registered on contract manufacturing basis.
Case No.21 Transfer of Products to New Title (Manufacturing Site Remains Same).
M/s Daneen Pharma (Pvt), Ltd Lahore has requested for transfer of below mentioned
registered products from old title i.e M/s Kings Pharmaceuticals 27-Sunder Industrial Estate,
Raiwind Road, Lahore. to their new title i.e M/s. Daneen Pharma (Priviate) Limited, 27-Sunder
Industrial Estate, Raiwind Road, Lahore (manufacturing site remains same).
S.No Reg No NAME OF DRUG (S) & COMPOSITION Remarks
1. 064703 Keprex 1gm Injection Last renewal dated
Each vial contains:- 06.11.2017
Cefotaxime sodium eq to
Cefotaxime …………………….1gm
(USP Specification)
2. 064693 Blucef 1gm Injection I.V Last renewal dated
Ceftriaxone sodium eq to:-
Ceftriaxone…………………………….1gm
(USP Specification)
3. 064700 Kezidime 250mg injection Last renewal dated
Ceftazidime…………..250mg
(USP Specification)
4. 069312 Velodine 250mg Injection Last renewal dated
Cephradine……………..250mg
(USP Specification)
5. 064687 Velodine 125mg Dry powder suspension Last renewal dated
Each 5ml contains:- 06.11.2017
Cephradine as monohydrate……………..125mg
(USP Specification)
6. 078786 Harod Tablet 250mg Initial registration
Each film coated tablet contains:- 23.10.2014
Ciprofloxacin as hydrochloride…..250mg
(USP Specification)
7. 064706 Aleeva 500mg Injection Last renewal dated
Each vail contains:- 06.11.2017
Cefepime (as Hcl)……………………..500mg
(USP Specification)
8. 078788 Victor Tablet 10mg Initial Registration
Each film coated tablet contains:- dated 23.10.2014
Montelukast as sodium………………..10mg Formulation exist in
(Manufacturer‘s Specification) USP
9. 078782 Danon Tablet 20mg Initial registration
Each tablet contains:- 23.10.2014
Piroxicam beta cyclodextrin eq to Approved with
Piroxicam………………………………20mg innovator’s spec.
(Manufacturer‘s Specification)
10. 069311 Aleeva 1gm Injection Last renewal dated
Cefepime (as HCl)……………………..1gm
(USP Specification)
11. 064688 Velodine 250mg Dry powder suspension Last renewal dated
Cephradine ……………..250mg
(USP Specification)
12. 078787 Harod Tablet 500mg Initial Registration
Each film coated tablet contains:- dated 23.10.2014
Ciprofloxacin as hydrochloride…..500mg
(USP Specification)
13. 064712 Kadoxil 500mg Capsule
Each capsule contains:- Last renewal dated
Cefdroxil Monohydrate eq to:- 06.11.2017
Cefadroxil………………….500mg
(USP Specification)
14. 064696 Xytol 2gm injection Last renewal dated
Each vial conatains:- 06.11.2017
Cefoperazone (as sodium)…………………1gm Formulation exist in
Sulbactam (as sodium)…………………….1gm Japnese pharmacoepia
(Kings Specification)
15. 064701 Kingrox 250mg Injection Last renewal dated
Cefuroxime…………………………..250mg
(USP Specification)
16. 064698 Vivorex 1gm Injection Last renewal dated
Cefpirome (as sulphate)………………….1gm
(USP Specification)
17. 067709 Blucef 250mg injection I.M Last renewal dated
Ceftriaxone……………………………250mg
18. 064694 Kezidime 500mg injection Last renewal dated
Ceftazidime…………..500mg
(USP Specification)
19. 064704 Keprex 250mg Injection Last renewal dated
Cefotaxime…………………….250mg
(USP Specification)
20. 078783 Kadura Tablet 250mg Initial Registration
Each film coated tablet contains: 23.10.2014
Azithromycin as dihydrate ……….250mg Formulation exist in
21. 064708 Cariclor Capsules Initial Registration
Each capsule contains:- 06.11.2017
Cefaclor as monohydrate……………250mg
(USP Specification)
22. 064699 Vivorex 500mg Injection Last renewal dated
Cefpirome (as sulphate)…………………500mg
(USP Specification)
23. 064683 Kadoxil 250mg Dry Suspension Last renewal dated
Cefadroxil as monohydrate……………250mg
(USP Specification)
24. 064710 Velodine 500mg Capsule Last renewal dated
Cephradine……………….500mg
(USP Specification)
25. 064697 Xytol 1gm Injection Last renewal dated
Cefoperazone (as sodium)………………500mg
Sulbactam (as sodium)…………………..500mg Formulation exist in
(King‘s Specification) Japnese pharmacoepia
26. 064714 Cestar 400mg Capsule Last renewal dated
Cefixime as Axitel……………………400mg Formulation corrected
(King‘s Specification) as Cefixime as
trihydrate with
Japnese pharmacoepia
27. 078784 Fordim tablet 250mg Initial Registration
Levofloxacin as hemihydrates…………..250mg Formulation exist in
28. 064709 Velodine 250mg Capsule Last renewal dated
Cephradine……………….250mg
(USP Specification)
29. 078781 Kipra tablet 400mg Initial Registration
Each film coated tablet contains:- 23.10.2014
Moxifloxacin as hydrochloride……..400mg Approved with
(Manufacturer‘s Specification) innovator’s spec.
30. 064707 Kingzon 500mg Injection Last renewal dated
Cefoperazone sodium eq to:-
Cefoperazone……………………………500mg
(USP Specification)
31. 064695 Blucef 500mg Injection Last renewal dated
Ceftriaxone …………………………..500mg
(USP Specification)
32. 064705 Keprex 500mg Injection Last renewal dated
Cefotaxime…………………….500mg
(USP Specification)
33. 064682 Kadoxil 125mg Dry Suspension Last renewal dated
Cefadroxil as monohydrate……………125mg
(USP Specification)
34. 069310 Velodine 500mg Injection Last renewal dated
Cephradine…………………….500mg
(USP Specification)
35. 064713 Cariclor 500mg Capsules Last renewal dated
Cefaclor as monohydrate……………500mg
(USP Specification)
36. 078785 Fordim tablet 500mg Initial Registration
Levofloxacin as hemihydrates…………..500mg Formulation exist in
37. 067710 Blucef 500mg injection I.M Last renewal dated
Ceftriaxone sodium eq to:- Formulation exist in
Ceftriaxone……………………………500mg USP
38. 064692 Blucef 250mg injection I.V Last renewal dated
Ceftriaxone sodium eq to:- Formulation exist in
Ceftriaxone……………………………250mg USP
Sections approved; capsule (cephalosporin), suspension (cephalosporin) and
injection(cephalosporin), (as mentioned in panel inspection report dated 19.02.2014).
Firm has submitted following documents:
i. Application for transfer of products at new title with fee (Rs 20,000/- each product)
ii. Form-5
iii. Copy of DML & approval of new title by CLB dated 11th April 2018.
iv. Copy of registration letter/renewal status.
v. Last inspection report dated 19.02.2014 (grant of tablet general section)
vi. CRF clearance certificated valid till 31-12-2018
Decision: Registeration Board approved above mentioned products at new title of

manufacturing site i.e M/s. Daneen Pharma (Priviate) Limited, 27-Sunder
Industrial Estate, Raiwind Road, Lahore (previously M/s Kings
Pharmaceuticals 27-Sunder Industrial Estate, Raiwind Road, Lahore.).
Moreover the Board also approved change of Brand name of Velodine range
of products to Ciphrine.
H. Division of Biological Evaluation & Research
Case No.1 Imported Veterinary Biologicals From non- reference countries.
Name and address of Importer M/s Huzaifa International, Commercial Area, Aziz Bhatti Town,
Sargodha Pakistan
Name and address of M/s Jilin ZhengYe Biological Products Co., Ltd
Manufacturer No.1 LianMeng Street Economic Development Zone of JiLin City, China.
Brand Name +Dosage Form + POLY-VAC ND.EDS
Strength Each single dose contains:
Newcastle disease virus (La Sota strain), before Inactivated at least
…………………..108.0EID50/0.1ml
Egg drop syndrome virus EDS 76(911 strain), before Inactivated at least
……..107.0TCID50/ml
Diary No. Date of R& I & fee 23435/2017(R&I) dated 07-12-2017.
PKR. 100,000/- dated 07-12-2017.
Composition Each single dose contains:

Inactivated Newcastle disease virus (La Sota strain), before Inactivated at
least ………108.0EID50/0.1ml
Egg drop syndrome virus EDS 76(911 strain), before Inactivated at least
………107.0TCID50/ml : 30%
Excipients:
White Oil ………64.4%
Span ……………2.8%
Tween ………….2.8%
Pharmacological Group Poultry Vaccine
Finished Product Specification B.P
Shelf Life 12 months ( 2-80C)
Document Details Valid legalized GMP No 07007 issue date 22-07-2016, valid 22-07-2016
to 21-07-2021
Valid legalize FSC No. 171100B0/25950 Issuing date 18-04-2017.
Authorization letter.
Copy of DSL No. 0011000 0001489 valid upto 20-11-2019.
Pack size & Demanded Price 250ml/vial /Decontrolled
Products already registered in CEVAC ND EDS K VACCINE
Pakistan (ELECTROVET ISLAMABAD)
Decision: Registration Board approved the product as per valid legalized CoPP subject to
compliance of current Import Policy for Finished Drugs.
Name and address of Importer M/s Huzaifa International, Commercial Area, Aziz Bhatti Town,
Sargodha Pakistan
Name and address of M/s Jilin ZhengYe Biological Products Co., Ltd
Manufacturer No.1 LianMeng Street Economic Development Zone of JiLin City, China.
Brand Name +Dosage Form + POLY-VAC ND.IB
Strength Each single dose contains:
Newcastle disease virus(La Sota strain) at least ………106.0EID50/dose
Chicken infectious bronchitis virus (H120 strain) at least
………103.5EID50/dose
Diary No. Date of R& I & fee 23436/2017(R&I) dated 07-12-2017.
PKR. 100,000/- dated 07-12-2017.
Composition Each single dose contains before freeze drying:
Live Newcastle disease virus(La Sota strain) at least
………106.0EID50/dose
Chicken infectious bronchitis virus(H120 strain) at least
………103.5EID50/dose 87.5%
Protective Agent 12.5%
Gelatin …….1.5%
Sucrose………5%
Skim Milk…. 5%
Water………. 88.5%
Pharmacological Group Biological product, Poultry Vaccine
Type of Form Form 5-A dated 06-12-2017.
Finished Product Specification B.P
Shelf Life 18 months
Document Details Valid legalized GMP No 07007 issue date 22-07-2016, valid 22-07-2016
to 21-07-2021
Valid legalize FSC No. 171100B0/25948 Issuing date 18-04-2017.
Authorization letter.
Copy of DSL No. 0011000 0001489 valid upto 20-11-2019.
Pack size & Demanded Price 1000ml dose/vial & Decontrolled
Products already registered in MEDIVAC ND-IB VACCINE
Pakistan
Decision: Registration Board approved the product as per valid legalized CoPP subject to
compliance of current Import Policy for Finished Drugs.
Case No. 2 Imported veterinary Biologicals applied by M/s Huzaifa International

Sargodha approved in 274th meeting of Registration Board.
Following products of M/s Huzaifa International Sargodha was approved in 260th meeting
of Registration Board as per following details:
Manufacturer Brand Name, Reg No & Composition Document Specification, Pack

Details & size & MRP
M/s Komipharm PRO-VAC ABBN Legalized As per Innovator
International Co., Ltd. Reg No.088167 GMP dated (GallimuneTM308 by
17, Gyeonje-Ro, Each dose(0.5ml) contains: 24/11/2016 Marial Italia)
Siheung-Si, Gyeonggi- Infectious Bronchitis Virus (M-41 strain), Specifications
Do, The republic of before inactivation…. Min. 107.5EID50 Legalized
Korea Infectious Bronchitis Virus (KM91 strain), Free Sale Pack Size:
[Formerly: 1236-6, before inactivation. Min. 107.5 EID50 certificate 1000doses/ bottle
Chongwang-Dong, Newcastle Disease Virus (Ulster 2C dated Decontrolled
Shihung-Si, Kyonggi- Strain), before inactivation…. Min. 27/12/2016
Do, Republic of 109.0EID50
Korea] Inactivated Avian Influenza Virus
(A/Chicken/Korea/01310/2001(H9N2),
CE20 strain) …….108.5EID50
The registration letter will be processed as per innovator specification.
Case No. 3 Under process registration letter.
The opinion of the Registration Board regarding issuance of registration letter is

required for following matter:
i. The specifications of the approved products are not in accordance with
specification of 267th Registration Board
Decision: Registration Board deliberated that in 276th meeting Registration board has
authorized its chairman for issuance of registration letters in accordance with
decisions of 264th and 266th meeting. Therefore, all such cases may be
processed accordingly.
Meeting ended with a vote of thanks to and from the chair.
End of Document

Minutes of 281st Meeting of Registration Board

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Minutes of 281st Meeting of Registration Board

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MINUTES OF 281st MEETING OF REGISTRATION BOARD

HELD ON 11TH TO 13TH APRIL, 2018

Item No. Detail of Item Pages

Drug Regulatory Authority of Pakistan

Minutes of 281st Meeting of Registration Board (11th-13th April, 2018) Page 1

Minutes of 281st Meeting of Registration Board (11th-13th April, 2018) Page 2

a. Minutes of 279th meeting of Registration Board.

b. Minutes of 280th meeting of Registration Board.

Decision: Registration Board confirmed the minutes as approved by Chairman,

Minutes of 281st Meeting of Registration Board (11th-13th April, 2018) Page 3

Minutes of 281st Meeting of Registration Board (11th-13th April, 2018) Page 4

Case No. 04 Registration applications for local manufacturing of (veterinary) drugs

Total Cases: 958

Minutes of 281st Meeting of Registration Board (11th-13th April, 2018) Page 5

Sr. No Name of Evaluator Title

1. Mr. Muhammad Tahir Waqas Evaluator PEC-I

2. Mr. Ammar Ashraf Awan Evaluator PEC-II

3. Mr. Muhammad Haseeb Tariq Evaluator PEC-III

4. Mst.Farzana Raja Evaluator PEC-IV

5. Mst. Iqra Aftab Evaluator PEC-V

6. Mr. Muhammad Umar Latif Evaluator PEC-VI

7. Mst. Sidra Khalid Evaluator PEC-VII

8. Mst. Haleema Sharif Evaluator PEC-VIII

9. Mst. Najia Saleem Evaluator PEC-XI

10. Syed Ajwad Bukhari Evaluator PEC-XII

11. Mst. Mehwish Javed Khan Evaluator PEC-XIII

12. Mr. Muhammad Ahsan Hafiz Evaluator PEC-XIV

Minutes of 281st Meeting of Registration Board (11th-13th April, 2018) Page 6

The formulation of ―L-ornithine L-aspartate (5gm per10ml) injection/infusion‖ was

Minutes of 281st Meeting of Registration Board (11th-13th April, 2018) Page 7

Minutes of 281st Meeting of Registration Board (11th-13th April, 2018) Page 8

Minutes of 281st Meeting of Registration Board (11th-13th April, 2018) Page 9

Minutes of 281st Meeting of Registration Board (11th-13th April, 2018) Page 11

Minutes of 281st Meeting of Registration Board (11th-13th April, 2018) Page 13

Composition Each film coated tablet contains:

Composition Each film coated tablet contains:

Composition Each film coated tablet contains:

Composition Each film coated tablet contains:

Minutes of 281st Meeting of Registration Board (11th-13th April, 2018) Page 16

Brand Name +Dosage Form +Strength Sertex tablet 100mg

Composition Each film coated tablet contains:

Brand Name +Dosage Form +Strength Sertex tablet 50mg

Composition Each film coated tablet contains:

Minutes of 281st Meeting of Registration Board (11th-13th April, 2018) Page 17

Minutes of 281st Meeting of Registration Board (11th-13th April, 2018) Page 18

Composition Each film coated tablet contains:

Minutes of 281st Meeting of Registration Board (11th-13th April, 2018) Page 19

Composition Each film coated tablet contains:

Composition Each film coated tablet contains:

Minutes of 281st Meeting of Registration Board (11th-13th April, 2018) Page 20

Composition Each film coated tablet contains:

Composition Each film coated tablet contains:

Composition Each capsule contain:

Minutes of 281st Meeting of Registration Board (11th-13th April, 2018) Page 21

Composition Each 5ml contains:

Composition Each tablet contains:

Minutes of 281st Meeting of Registration Board (11th-13th April, 2018) Page 22

Composition Each ml contains:

Composition Each ml contains:

Minutes of 281st Meeting of Registration Board (11th-13th April, 2018) Page 23

Composition Each ampoule contains:

Minutes of 281st Meeting of Registration Board (11th-13th April, 2018) Page 24

Composition Each ml contains:

Composition Each ml contains: