Minutes of 283rd Meeting of Registration Board

MINUTES OF 283rd MEETING OF REGISTRATION BOARD
HELD ON 27th TO 29th JUNE, 2018

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Item No. Detail of Item Pages

I. Confirmation of Minutes 3
II. Miscellaneous Cases 4-5
III. Division of Pharmaceutical Evaluation &Registration 6-571

 Pharmaceutical Evaluation Cell (PEC) 6-478
 Registration-I 479-494
 Registration-II 495-509
 Registration-III 510-524
 Registration-IV 525-527
 Registration-V 528-543
544-571
 RRR Section
IV. Division of Biological Evaluation and Research 572-619
V. Additional Agenda 620-899
Drug Regulatory Authority of Pakistan

T.F. Complex, Mauve Area, G 9/4
Islamabad.
Minutes for 283rd meeting of Registration Board, DRAP (27-29th June, 2018) 1
283rd meeting of Registration Board was held on 27–29th June, 2018 in the Committee Room
of Drug Regulatory Authority of Pakistan, T.F Complex, 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, Faculty of Pharmacy,
Univeristy of Karachi.
2. Maj.Gen. Dr. Tahir Mukhtar Sayed Member
Commandant AFIRM / Head of Department of Medicine,
Army Medical College, Rawalpindi
3. Prof. Dr. Ghulam Sarwar, Member
Dean, Faculty of Pharmacy,
Jinnah University for Women, Karachi
4. Dr. Qurban Ali, Member
Ex-Director General, NVL/ Veterinary Expert
5. Dr. Amanullah Khan, Member
Director, Drugs Testing Laboratory, Quetta
Government of Balochistan
6. Dr. Muhammad Khalid Jawed, 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, Biological Drugs Divisi, DRAP
11. Dr. Hafsa Karam Ellahi, Additional Director, Member
Representative of QA&LT Division, DRAP.
12. Mr. Abdullah, Secretary
Additional Director (PE&R), DRAP.
Mr. Zaheeruddin M.Babar (Dy.Director-Reg.I), Mr.Muhammad Amin (Dy.Director-Reg.II),

Dr.Muhammad Aleem Akhtar (Dy.Director-Reg.IV), Mst. Tehreem Sara (Dy.Director-RRR) and
Mr.Asif Jalil (Incharge PEC) presented the agenda of PE&R Division assisted by respective Assistant
Directors. Director (Biological Drugs) and Additional Director (QA&LT) were assisted by respective
Assistant Directors to represent concerned agenda.
Mr. Nawaz Ahmad, Ch.Yousaf Ali (PPMA), Mr. Rashid Mureed, Nadeem Alamgir (Pharma
Bureau) and Mr. Kamran Anwar (PCDA) attended the meeting as observers.
Item No. I: Confirmation of Minutes of 282nd meeting of Registration Board.
282nd meeting of Registration Board was held on 14 to 15th May, 2018. The draft
minutes were circulated among the members of meeting on 15th June, 2018 with the request to forward
their comments (if any) within five days but no comments were received.
Decision: Registration Board approved / confirmed the minutes of 282nd meeting.
Item No. II: Miscellaneous cases.
Case No. 01: Amendment in Rule 26 of Drugs (Licensing, Registering and Advertising) Rules,
1976 by addition of Form 5-F (CTD) as application for Registration of Human
Pharmaceuticals and Biological Drugs.
Section 7 subsection c (ix) and Schedule 1 (8) under section 2 of DRAP Act 2012, direct to
implement international standards for ensuring safety, efficacy and quality. Accordingly, Registration
Board in its 264th meeting deliberated on the adoption of Common Technical Document (CTD) as
application of registration for human pharmaceuticals and biological drugs. Keeping in view the
international acceptance, consistency of application of registration, well organized submissions in the
form of CTD, the Board as follows:
Registration Board was given a presentation on agenda item. The Board deliberated in
detail and decided as follows:
a. Common Technical Dossier (CTD) shall be adopted for submission of registration application
of pharmaceutical drugs. The Board advised to amend relevant rules for this purpose.
b. For six (06) months, applicants can submit registration application on existing forms (Form
5 / 5A / 5D / 5E) as well. However, during this period voluntary submissions on CTD format
will be processed on a separate new queue for CTD applications for improved regulatory
compliance.
c. In order to facilitate and encourage the submissions on CTD, Registration Board endorsed
above explainations and also approved following exemptions in the modules and sub-modules.
Following exemptions are applicable to formulations already approved by reference
regulatory authorities.
Module Section Sub-section New Drug Generic Drug
Product Product
2 2.4 Non-Clinical Overview Not Exempted Exempted
2.5 Clinical Overview Not Exempted Exempted
2.6 Non-Clinical Written and Tabulated Summaries Not Exempted Exempted
2.7 Clinical Summary Not Exempted Exempted

3 (3.2.S) 3.2.S.2 3.2.S.2.3 Not Exempted Exempted
Drug Brief Description of Manufacturing Process and
Substance Process Controls
3.2.S.3.4 Exempted Exempted
Control of critical steps and Intermediates
(Closed Part)
3.2.S.3.5 Not Exempted Exempted
Summary of Process Validation and/or
Evaluation
3.2.S.3.6 Exempted Exempted
Brief Manufacturing Process Development
3 Drug 3.2.P.2.2.1 Not Exempted Not Exempted
(3.2.P) Product Pharmaceutical Equivalence through
Comparative Dissolution Profile
3.2.R 3.3.R.3 Exempted Exempted
Product Interchangeability (Bioequivalence
Study Reports)
Bioequivalence Exempted Exempted
4 4.2.3 4.2.3.3 Exempted Exempted
Genotoxicity
4.2.3.4 Exempted Exempted
Carcinogenicity
Reproductive and Developmental Toxicity
Local Tolerance
Other toxicity studies
5 Clinical Innovator (In-house and Published) Not Exempted Not
Studies Applicable
New Drug Generic version (Published data) Not Applicable Not Exempted
It is appraised that Federal Government has approved the amendment in rule 26 of Drugs
(Licensing, Registering and Advertising) Rules, 1976 for incorporation of Common Technical
Document (CTD) as Form 5-F for application of registration of pharmaceuticals and biological drugs
which has been notified vide S.R.O. 713(I)/2018 dated 09.06.2018.
Decision: Registration Board appreciated promulgation of S.R.O.713(I)/2018 dated
09.06.2018 and advised to present implementation plan for consideration by the
Board.
Case No. 02: Registration of Drugs Pending for Policy Decision:
Matter for registration of drugs for treatment of erectile dysfunction and pre-mature ejaculation
were considered by Registration Board as firms have submitted applications for import and local
manufacturing. The Board deferred these applications for further discussion as matter is pending since
1998.
Decision: Registration Board advised to compile cases with complete details i.e. decision of
Registration Board, Appellate Board and present accordingly.
Item No. III: Division of Pharmaceutical Evaluation & Registration
Pharmaceutical Evaluation Cell
S.No. Detail
Case No. 01 Registration applications for local manufacturing of (Human) drugs
a. New cases
b. Deferred cases
Case No. 02 Registration applications of newly granted DML or New section
a. New DML
b. New/Additional section(s)
c. Remaining Molecules of NL/NS
d. Deferred cases
i. Human
ii. Veterinary
Case No. 03 Registration applications for local manufacturing of (veterinary) drugs
a. New Cases
b. Deferred
Case No. 04 Registration applications of categories to be considered on priority
a. Export Facilitation
b. Local manufacturing applications of priority categories defined by
Registration Board in its 257th meeting
c. Import applications of priority categories defined by Registration Board in its
257th meeting
Case No. 05 Registration applications of import cases
a. New Cases (Human)
b. New Cases (Veterinary)
c. Deferred cases
i. Human
Case No. 06 Registration applications of drugs for which stability study data is required
to be verified
a. Onsite verification of stability data
b. Exemption from onsite verification of stability data
Case No. 07 Miscellaneous cases
Total Cases: 973
Sr. No Name of Evaluator Title
1 Mr Jawad Ali 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. 01: Registration Applications for Local Manufacturing of (Human) Drugs.
a. New cases
Evaluator PEC-XI
1. Name and address of manufacturer / M/s Danas Pharmaceuticals (Pvt.) Ltd., 312-Industrial Triangle,
Applicant Kahuta Road, Islamabad.
Brand Name +Dosage Form + Strength Soriodan ointment 0.005%
Composition Each gram contains:
Calcipotriol anhydrous….......0.05mg
Diary No. Date of R& I & fee Dy. No.8530; 12-07-2017; Rs.20,000/- (12-07-2017)
Pharmacological Group Anti-psoriatic
Type of Form Form-5
Finished product Specifications BP
Pack size & Demanded Price 30g; As per SRO
Approval status of product in MHRA approved
Reference Regulatory Authorities
Me-too status (with strength and Daivonex ointment of M/s Zam Zam Corp.
dosage form)
GMP status 03.10.2017; GMP granted
Remarks of the Evaluator Firm has approved ointment/cream/gel/lotion section.
Decision: Approved.
2. Name and address of manufacturer / M/s Danas Pharmaceuticals (Pvt.) Ltd., 312-Industrial Triangle,
Brand Name +Dosage Form + Strength Soriodan cream 0.005%
Calcipotriol (as monohydrate)….......0.05mg
Pharmacological Group Anti-psoriatic
Type of Form Form-5
Approval status of product in USFDA approved
Me-too status (with strength and Calcipot Cream of M/s Valor Pharmaceuticals
dosage form)
GMP status 03.10.2017; GMP granted
Remarks of the Evaluator Firm has approved ointment/cream/gel/lotion section.
Decision: Approved.
3. Name and address of manufacturer / M/s Weather Folds Pharmaceuticals, Plot No. 69/2 Phase-II
Applicant Industrial Estate, Hattar.
Brand Name +Dosage Form + Strength Etor 60mg tablet
Composition Each film coated tablet contains:
Etoricoxib….......60mg
Pharmacological Group NSAID
Type of Form Form-5
Finished product Specifications Not claimed
Pack size & Demanded Price 10’s; As per SRO
Approval status of product in Arcoxia 60mg tablet of M/s
Reference Regulatory Authorities Grunenthal Ltd, (MHRA approved)
Me-too status (with strength and Arcox 60mg tablet by M/s MAQ Pharmaceuticals
dosage form)
GMP status Last GMP inspection was conducted on 15-09-2017 and
the report concludes the firm to be GMP compliant.
Remarks of the Evaluator No official monograph of the applied formulation exists in
available editions of USP/BP/IP/JP.
Decision: Approved with innovator’s specification.
Brand Name +Dosage Form + Strength Zeph 10mg tablet
Zafirlukast….......10mg
Pharmacological Group Leukotriene receptor antagonist
Type of Form Form-5
Approval status of product in Accolate 10mg tablet (USFDA Approved)
Me-too status (with strength and Zilesta 10mg tablet of M/s Genix Pharma
dosage form)
Brand Name +Dosage Form + Strength Zeph 20mg tablet
Zafirlukast….......20mg
Type of Form Form-5
Approval status of product in Accolate 20mg tablet (USFDA Approved)
Me-too status (with strength and Zilesta 20mg tablet of M/s Genix Pharma
dosage form)
6. Name and address of manufacturer / M/s Hicon Pharmaceuticals, 131-Industrial Estate, Hayatabad.
Applicant
Brand Name +Dosage Form + Strength Dizzex 16mg tablets
Composition Each tablet contains:
Betahistine dihydrochloride ….......16mg
Pharmacological Group Antivertigo
Type of Form Form-5
Pack size & Demanded Price 3x10’s; As per SRO
Approval status of product in Serc (TGA approved)
Me-too status (with strength and Serc of M/s Highnoon
dosage form)
GMP status Last GMP inspection dated 26-07-2017; satisfactory level of
cGMP compliance.
Remarks of the Evaluator
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Fertyl 50mg tablets
Clomifene citrate ….......50mg
Pharmacological Group Synthetic ovulation stimulant
Type of Form Form-5
Approval status of product in Clomid tablet (USFDA approved)
Me-too status (with strength and Clomidex tablets of M/s CSH pharmaceuticals
dosage form)
cGMP compliance.
Remarks of the Evaluator Firm has claimed BP specifications while official monograph of
the applied formulation exists in USP.
Decision: Approved with change of brand name and USP 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
Brand Name +Dosage Form + Strength Ebacon 10mg tablets
Ebastine ….......10mg
Pharmacological Group Antihistamine
Type of Form Form-5
Finished product Specifications Manufacturer’s specifications
Approval status of product in ANSM approved
Me-too status (with strength and Nosetine tablets 10mg of M/s Technovision Pharmaceuticals
dosage form)
cGMP compliance.
Remarks of the Evaluator Firm has claimed manufacturer’s specifications while official
monograph of the applied formulation exists in JP.
Decision: Approved with JP specification.
Applicant
Brand Name +Dosage Form + Strength D-Lor 5mg tablets
Desloratadine ….......5mg
Type of Form Form-5
Finished product Specifications USP
Approval status of product in ANSM, USFDA approved
Me-too status (with strength and Desdine 5mg tablet of M/s Hygeia Pharmaceuticals
dosage form)
cGMP compliance.
Remarks of the Evaluator  No official monograph of the applied formulation exists
in available editions of USP/BP/IP/JP.
 Firm has revised formulation from uncoated to film
coated tablets without submission of requisite fee for
formulation revision.
Decision: Deferred for submission of fee for revision of formulation.
Applicant
Brand Name +Dosage Form + Strength D-Lor 2.5mg/5ml syrup
Composition Each 5ml contains:
Desloratadine ….......2.5mg
Type of Form Form-5
Finished product Specifications Manufacturer’s specification
Pack size & Demanded Price 60mlx1’s; As per SRO
Approval status of product in TGA approved
Me-too status (with strength and Delergy 2.5mg/5ml Syrup of M/s Barret Hodgson
dosage form)
cGMP compliance.
Remarks of the Evaluator  No official monograph of the applied formulation exists
in available editions of USP/BP/IP/JP.
Applicant
Brand Name +Dosage Form + Strength Benzapride 25mg tablet
Levosulpiride ….......25mg
Pharmacological Group Antipsychotic
Type of Form Form-5
Approval status of product in LEVOPRAID 25mg tablet
Reference Regulatory Authorities (AIFA Italy Approved)
Me-too status (with strength and Vesulpid tablet by Martin Dow
dosage form)
cGMP compliance.
Applicant
Brand Name +Dosage Form + Strength Benzapride 50mg tablet
Levosulpiride ….......50mg
Type of Form Form-5
Approval status of product in LEVOPRAID 50mg tablet
Reference Regulatory Authorities (AIFA Italy Approved)
Me-too status (with strength and Vesulpid tablet by Martin Dow
dosage form)
cGMP compliance.
Applicant
Brand Name +Dosage Form + Strength Monticon 5mg tablet
Composition Each chewable tablet contains:
Montelukast (as sodium)….......5mg
Type of Form Form-5
Approval status of product in Singulair (USFDA Approved)
Me-too status (with strength and Pulmease chewable tablet 5mg of M/s Kaizen pharmaceuticals
dosage form)
cGMP compliance.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Oxicam 8mg tablet
Lornoxicam ….......8mg
Type of Form Form-5
Approval status of product in Xefo 8mg tablet (Swiss Medic approved)
Me-too status (with strength and Zafon 8mg tablet of M/s Getz pharma
dosage form)
cGMP compliance.
Applicant
Brand Name +Dosage Form + Strength Glim 2mg tablet
Glimepiride ….......2mg
Pharmacological Group Sulfonylureas
Type of Form Form-5
Me-too status (with strength and Glimera 2mg tablet of M/s PPP
dosage form)
cGMP compliance.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Segor 0.25mg/5ml syrup
Pizotifen as hydrogen malate ….......0.25mg
Pharmacological Group Anti-migraine preparations
Type of Form Form-5
Pack size & Demanded Price 1x60ml; As per SRO
1x120ml; As per SRO
Approval status of product in Sanomigran elixir (MHRA approved)
Me-too status (with strength and Zigor Syrup 0.25mg/5ml by M/s Onyx Pharma
dosage form)
cGMP compliance.
Remarks of the Evaluator  No official monograph of the applied formulation exists in
 Clinical indications mentioned in the dossier are
 Anorexia in underweight patients
 Mood elevation in the elderly
 Prophylactic (interval) treatment of migraine.
Decision: Registration Board rejected the application as applied clinical indication of “Anorexia in
under weight patients” is not approved by any reference regulatory authority.
17. Name and address of manufacturer / M/s Bio-Labs (Pvt.) Ltd., 145 Industrial Triangle, Kahuta Road,
Applicant Islamabad.
Brand Name +Dosage Form + Strength Ondast tablet 4mg
Ondansetron (as hydrochloride dihydrate)….......4mg
Pharmacological Group 5HT3 receptor antagonist
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s and 100’s; As per SRO
Approval status of product in Ondansetron 4mg tablet (MHRA approved)
Me-too status (with strength and Zofran 4mg tablet of M/s GSK
dosage form)
GMP status Last GMP inspection dated 05-12-2017 and 06-12-2017; fair
compliance to GMP level.
Decision: Approved.
Brand Name +Dosage Form + Strength Ondast tablet 8mg
Type of Form Form-5
Pack size & Demanded Price 10’s and 12’s; As per SRO
Approval status of product in Ondansetron 8mg tablet (MHRA approved)
Me-too status (with strength and Zofran 8mg tablet of M/s GSK
dosage form)
Decision: Approved.
Brand Name +Dosage Form + Strength Ondast 8mg/4ml injection
Type of Form Form-5
Me-too status (with strength and Zofran 8mg/ml injection of M/s GSK
dosage form)
Remarks of the Evaluator  Firm has approved Liquid ampoule (General) section
Decision: Approved.
20. Name and address of manufacturer / M/s Wenovo Pharmaceuticals, Plot No. 31 & 32, Punjab Small
Applicant Industrial Estate, Taxilla, Rawalpindi.
Brand Name +Dosage Form + Strength Clominov tablet 50mg
Clomiphene citrate….......50mg
Minutes for 283 meeting of Registration Board, DRAP (27-29th June, 2018)
rd
14
Pharmacological Group Selective estrogen receptor modulator
Type of Form Form-5
Pack size & Demanded Price 2x10’s; As per policy of MoH
Approval status of product in Clomid (USFDA approved)
Me-too status (with strength and Clomicil tablet of M/s Lowitt pharma
dosage form)
the report concludes good level of GMP compliance.
monograph of the applied formulation exists in USP
Decision: Approved with USP 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.
21. Name and address of manufacturer / M/s UniMark Pharmaceuticals, Plot No. 7-A, Street No. S-7,
Applicant National Industrial Zone, Rawat, Islamabad.
Brand Name +Dosage Form + Strength Niglys SR 6.4mg tablets
Composition Each sustained release tablet contains:
Glyceryl trinitrate (diluted)….......6.4mg
Pharmacological Group Vasodilator/smooth muscle relaxant
Type of Form Form-5
Approval status of product in Sustac (MHRA approved)
Me-too status (with strength and Nitrosustd SR 6.4mg tablet of M/s Zafa
dosage form)
GMP status Last GMP Inspection dated 20-9-2017 with conclusive
remarks of reasonable cGMP compliance.
monograph of the applied formulation exists in BP
Decision: Approved with BP specification.
22. Name and address of manufacturer / M/s Zephyr Pharmatec Pvt. Ltd., A-39, S.I.T.E. II, Super
Applicant Highway, Karachi.
Brand Name +Dosage Form + Strength Brisk SR tablets 100mg
Tramadol hydrochloride….......100mg
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 Zydol SR 100mg prolonged release tablets (MHRA approved)
Me-too status (with strength and Volpan SR 100mg tablets of M/s. Rotex Pharma
dosage form)
GMP status Last inspection report conducted on 18-07-2017
concluding good level of GMP compliance.
Decision: Approved.
Brand Name +Dosage Form + Strength Heilen tablet 20mg
Composition Each enteric coated tablet contains:
Rabeprezole sodium….......20mg
Pharmacological Group Proton pump inhibitor
Type of Form Form-5
Finished product Specifications Innovator’s specifications
Approval status of product in (USFDA approved)
Me-too status (with strength and Rezoo 20mg enteric coated tablet of M/s Standpharm
dosage form)
Brand Name +Dosage Form + Strength Heilen tablet 10mg
Rabeprezole sodium….......10mg
Type of Form Form-5
Me-too status (with strength and Rezoo 10mg enteric coated tablet of M/s Standpharm
dosage form)
Brand Name +Dosage Form + Strength Wizy tablets 400mg
Cefixime as trihydrate….......400mg
Pharmacological Group Cephalosporin
Type of Form Form-5
Pack size & Demanded Price 10’s; As per PRC’s price
Me-too status (with strength and Caricef 400mg tablet of M/s Sami
dosage form)
Remarks of the Evaluator Firm does not has approved manufacturing facility of “Tablet
(cephalosporin)” section.
Decision: Deferred for confirmation from Licensing division whether firm has approved
manufacturing facility of “Tablet (cephalosporin)” section.
Brand Name +Dosage Form + Strength Acurax tablets 400mg
Doxofylline….......400mg
Pharmacological Group Bronchodilator
Type of Form Form-5
Pack size & Demanded Price 10’s; As per PRC’s price
Approval status of product in Italian Medicine Agency (AIFA) Italy approved
Me-too status (with strength and Profylline tablet 400mg of M/s Kaizen
dosage form)
 Original fee challan for Accurax 500mg tablets is attached
instead of Accurax 400mg tablets.
 Firm has revised formulation from film coated tablets to
uncoated tablets without submission of requisite fee.
Decision: Deferred for following:
 Original fee challan for applied formulation.
 Submission of fee for revision of formulation.
Applicant Highway, Karachi. Contract manufacturing by M/s S.J.&G.
Fazul Ellahie (Pvt.) Ltd. E/46, S.I.T.E. Karachi.
Brand Name +Dosage Form + Strength Ozop injection 40mg
Composition Each vial contains:
Omeprazole as sodium (lyophilized powder)….......40mg
Type of Form Form-5
Pack size & Demanded Price 1’s vial; As per PRC’s price
Approval status of product in Omeprazole 40mg powder for solution for infusion (UK-
Reference Regulatory Authorities MHRA approved)
Me-too status (with strength and Fymezole dry powder injection IV 40mg of M/s Fynk
dosage form) Pharmaceuticals
GMP status Last inspection report of M/s Zephyr Pharmatech conducted on
18-07-2017 concluding good level of GMP compliance.
Last GMP Inspection of M/s S.J. & G. Fazul Ellahie
conducted on 12-07-2017 with conclusive remarks of
good cGMP compliance.
Remarks of the Evaluator M/s Zephyr Pharmatec has 9 approved sections,
and the firm has no product already registered under the contract
manufacturing as confirmed by relevant registration section.
M/s S.J.&G. Fazul Ellahie (Pvt.) Ltd. has approved
Lyophilization (sterile area) powder section.
Decision: Deferred for clarification of applied dosage form whether lyophiloized powder or
lyophilized cake.
Brand Name +Dosage Form + Strength Ozop injection 20mg
Omeprazole as sodium (lyophilized powder)….......20mg
Type of Form Form-5
Approval status of product in Could not be confirmed in this strength
Me-too status (with strength and Vify Injection 20mg of M/s S.J.&G
dosage form)
Last GMP Inspection of M/s S.J.&G. Fazul Ellahie
Shortcomings:
 Evidence of approval of applied formulation, in reference
regulatory authorities/agencies which were
declared/approved by the Registration Board in its 275th
meeting.
 Clarification of applied dosage form whether lyophiloized powder or lyophilized cake.
 Evidence of approval of applied formulation, in reference regulatory authorities/ agencies
which were adopted by the Registration Board in its 275th meeting.
Brand Name +Dosage Form + Strength Keuz injection 40mg
Esomeprazole as sodium (lyophilized powder)….......40mg
Type of Form Form-5
Approval status of product in Nexium IV(USFDA approved)
Me-too status (with strength and Nexum 40mg Injection of M/s Getz
dosage form)
lyophilized cake.
Contract manufacturing by M/s S.J.&G. Fazul Ellahie (Pvt.)
Ltd. E/46, S.I.T.E. Karachi.
Brand Name +Dosage Form + Strength Keuz injection 20mg
Esomeprazole as sodium (lyophilized powder)….......20mg
Type of Form Form-5
Me-too status (with strength and Contour 20mg Injection of M/s S.J.&G. Fazul Ellahie
dosage form)
lyophilized cake.
Contract manufacturing by M/s S.J.&G. Fazul Ellahie (Pvt.)
Ltd. E/46, S.I.T.E. Karachi.
Brand Name +Dosage Form + Strength Linta infusion 200mg
Linezolid….......200mg
Pharmacological Group Antibacterial
Type of Form Form-5
Pack size & Demanded Price 100ml; As per PRC’s price
Approval status of product in Zyvox (USFDA approved)
Me-too status (with strength and Linzol Infusion 200mg/100ml of M/s Regal Pharmaceuticals
dosage form)
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.”
Type of Form Form-5
dosage form)
as under;
Type of Form Form-5
dosage form)
as under;
Brand Name +Dosage Form + Strength Venko injection 500mg
Vancomycin as hydrochloride….......500mg
Type of Form Form-5
Me-too status (with strength and Maparix 500mg Injection of M/s S.J.&G. Fazul Ellahie
dosage form)
lyophilized cake.
Brand Name +Dosage Form + Strength Venko injection 1Gm
Vancomycin as hydrochloride….......1gm
Type of Form Form-5
Me-too status (with strength and Maparix 1gm Injection of M/s S.J.&G. Fazul Ellahie
dosage form)
lyophilized cake.
Brand Name +Dosage Form + Strength Zoronic injection 5mg
Composition Each 100ml vial contains:
Zoledronic acid as monohydrate….......5mg
Pharmacological Group Bisphosphonate
Type of Form Form-5
Pack size & Demanded Price 100ml vial; As per PRC’s price
Approval status of product in (MHRA approved)
Me-too status (with strength and Aclasta 5mg/100ml solution for infusion of M/s Novartis
dosage form)
Decision: Approved.
Brand Name +Dosage Form + Strength Tegecin injection 50mg
Tigecycline (lyophilized powder)….......50mg
Type of Form Form-5
Approval status of product in Tygacil (USFDA approved)
Me-too status (with strength and Tilane 50mg injection of M/s S.J.&G. Fazul Ellahie
dosage form)
Lyophilization (sterile area) powder.
lyophilized cake.
Brand Name +Dosage Form + Strength Xitocin injection 400mg/250ml
Moxifloxacin as hydrochloride….......400mg
Type of Form Form-5
Pack size & Demanded Price 250ml; Rs.1200/-
Approval status of product in Avelox (MHRA approved)
Me-too status (with strength and Moxibact 400mg Injection of M/s S.J.&G. Fazul Ellahie
dosage form)
Decision: Approved.
Brand Name +Dosage Form + Strength Noxilor injection 8mg
Lornoxicam (lyophilized powder)….......8mg
Type of Form Form-5
Pack size & Demanded Price 1’s vial; As per PRC price
Approval status of product in Xefo (EMA approved)
Me-too status (with strength and Zafon 8mg injection of M/s Getz
dosage form)
lyophilized cake.
Brand Name +Dosage Form + Strength Tikonin injection 400mg
Tieccoplanin (lyophilized powder)….......400mg
Type of Form Form-5
Approval status of product in Targocid 400mg powder for solution for injection/infusion
Reference Regulatory Authorities (MHRA approved)
Me-too status (with strength and Targocid injection 400mg of M/s Hoechst Pakistan Ltd
dosage form)
lyophilized cake.
Brand Name +Dosage Form + Strength Tikonin injection 200mg
Tieccoplanin (lyophilized powder)….......200mg
Type of Form Form-5
Approval status of product in Targocid 200mg powder for solution for injection/infusion
Reference Regulatory Authorities (MHRA approved)
Me-too status (with strength and Targocid injection 200mg of M/s Hoechst Pakistan Ltd
dosage form)
lyophilized cake.
42. Name and address of manufacturer / M/s GT Pharma (Pvt.) Ltd, Plot No. 713, Sunder Industrial
Applicant Estate, Lahore.
Brand Name +Dosage Form + Strength Spell 40 capsules
Composition Each capsule contains:
Esomeprazole magnesium enteric coated pellets eq. to
Esomeprazole….......40mg
Source of pellets: Vision Pharmaceuticals
Type of Form Form-5
Approval status of product in Ventra 40mg gastro-resistant capsule(MHRA approved)
Me-too status (with strength and ESORID 40mg by M/s Hilton Pharma.
dosage form)
GMP status 26-05-2017-Routine GMP Inspection; Firm is GMP compliant
Decision: Approved.
Brand Name +Dosage Form + Strength Apex 40 capsule
Omeprazole enteric coated pellets….......40mg
Type of Form Form-5
Approval status of product in Losec 40mg capsules (MHRA approved)
Me-too status (with strength and Orgid 40mg capsule of M/s Ciba pharmaceuticals
dosage form)
Decision: Approved.
Brand Name +Dosage Form + Strength Apex 20 capsule
Omeprazole enteric coated pellets….......20mg
Type of Form Form-5
Approval status of product in Losec 20mg capsules (MHRA approved)
Me-too status (with strength and Orgid 20mg capsule of M/s Ciba pharmaceuticals
dosage form)
Decision: Approved.
Brand Name +Dosage Form + Strength GT-Mycin drops 125mg/5ml
Clarithromycin as taste masked granules….......125mg
Source of granules: Surge Laboratories Pvt. Ltd.
Pharmacological Group Macrolide antibiotic
Type of Form Form-5
Pack size & Demanded Price 25ml; As per SRO
Approval status of product in Biaxin 125mg/5ml (USFDA approved)
Me-too status (with strength and Mycin drops 125mg/5ml of M/s Cardex Pharmaceutical
dosage form)
Remarks of the Evaluator The official monograph of applied formulation is available in
USP.
Decision: Approved with USP specification.
46. Name and address of manufacturer / M/s Crystolite Pharmaceuticals, Plot No. 1&2, Street S-2,
Applicant National Industrial Zone, Rawat, Rawalpindi.
Brand Name +Dosage Form + Strength Epilene 0.1% cream
Adapelene……………........1mg
Pharmacological Group Anti-acne
Type of Form Form-5
Me-too status (with strength and Acne-lene 0.1% cream of M/s Valour pharma
dosage form)
GMP status Last inspection report 17-10-2017 firm is operating at
a good level of cGMP as of today.
 Firm has approved cream/ointment (general) section
47. Name and address of manufacturer / M/s Medicraft Pharmaceuticals (Pvt.) Ltd., 126-B Hayatabad
Applicant Industrial Estate, Peshawar. Contract manufacturing by M/s
Bio-Labs (Pvt.) Ltd., Plot No. 145, Industrial Triangle, Kahuta
Road, Islamabad
Brand Name +Dosage Form + Strength Esobest injection 40mg
Esomeprazole as sodium….......40mg
Type of Form Form-5
Pack size & Demanded Price 1’s; As per PRC
Me-too status (with strength and Nexum 40mg Injection of M/s Getz
dosage form)
Remarks of the Evaluator M/s Medicraft Pharmaceuticals (Pvt.) Ltd has 9 approved
sections and the firm has no product already registered under the
contract manufacturing as confirmed by relevant registration
section.
M/s Bio-Labs (Pvt.) Ltd. has approved Lyophilization vial

section.
Decision: Registration Board deferred the case for assessment and confirmation of manufacturing
capacity of M/s Biolabs by panel to be constituted by Chairman Registration Board for further
granting contract manufacturing permission as the firm has already been granted approval for
contract manufacturing of numerous products.
Road, Islamabad
Brand Name +Dosage Form + Strength Vancobest injection 500mg
Pharmacological Group Anti-infective
Type of Form Form-5
Approval status of product in Vancomycin 500mg powder for concentrate for solution for
Reference Regulatory Authorities infusion vials (MHRA approved)
Me-too status (with strength and Vancotech 500mg dry powder for injection, of Fynk
dosage form) Pharmaceuticals.
section.
section.
Road, Islamabad
Brand Name +Dosage Form + Strength Vancobest injection 1gm
Type of Form Form-5
Approval status of product in Vancomycin 1gm powder for concentrate for solution for
Reference Regulatory Authorities infusion vials (MHRA approved)
Me-too status (with strength and Vancotech 1gm dry powder for injection, of Fynk
dosage form) Pharmaceuticals.
section.

section.
Road, Islamabad
Brand Name +Dosage Form + Strength Omed injection 40mg
Omeprazole as sodium….......40mg
Type of Form Form-5
Me-too status (with strength and Fymezole Dry Powder Injection IV 40mg of M/s Fynk
dosage form) pharmaceuticals
section.

section.
Road, Islamabad
Brand Name +Dosage Form + Strength Ultomed injection 40mg
Pantoprazole as sodium….......40mg
Type of Form Form-5
Me-too status (with strength and Pazole Dry Powder Injection IV 40mg of M/s Fynk
dosage form) pharmaceuticals
section.
section.
52. Name and address of manufacturer / M/s Scilife Pharma (Pvt.) Ltd., Plot No. 57/58-A2, Korangi
Applicant Creek Industrial Park, Karachi.
Brand Name +Dosage Form + Strength Febox tablet 40mg
Febuxostat….......40mg
Pharmacological Group Xanthine oxidase inhibitor
Type of Form Form-5
Pack size & Demanded Price 20’s and 30’s; As per DPC
Me-too status (with strength and Febuxin 40mg Tablet of M/s AGP
dosage form)
GMP status Last GMP inspection conducted on 05-12-2017, the report
concludes that firm is showing Good level of compliance.
53. Name and address of manufacturer / M/s Scilife Pharma (Pvt.) Ltd., Plot No. 57/58-A2, Korangi
Applicant Creek Industrial Park, Karachi.
Brand Name +Dosage Form + Strength Febox tablet 80mg
Febuxostat….......80mg
Pharmacological Group Xanthine oxidase inhibitor
Type of Form Form-5
Pack size & Demanded Price 20’s and 30’s; As per DPC
dosage form)
GMP status Last GMP inspection conducted on 05-12-2017, the report
concludes that firm is showing Good level of compliance.
54. Name and address of manufacturer / M/s Madera Pharmaceuticals (Pvt.) Ltd., Plot No. 2, St. No. N-
Applicant 4, National Industrial Zone, Rawat, Rawalpindi
Brand Name +Dosage Form + Strength Letromed tablet 2.5mg
Other brand name proposed:
Medzole
Metrolead
Letrozole….......2.5mg
Pharmacological Group Aromatase inhibitor
Type of Form Form-5
Me-too status (with strength and Femara tablet 2.5mg of M/s Novartis pharma
dosage form)
GMP status Last GMP inspection report dated 06-07-2017
concluding GMP compliance as of today.
Remarks of the Evaluator Official monograph of applied formulation is available in USP.
Decision: Approved with USP 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.
55. Name and address of manufacturer / M/s Madera Pharmaceuticals (Pvt.) Ltd., Plot No. 2, St. No.
Applicant N-4, National Industrial Zone, Rawat, Rawalpindi
Brand Name +Dosage Form + Strength Q-med tablet 100mg
Other brand name proposed:
Q-fem
Qued
Quetiapine as fumarate….......100mg
Type of Form Form-5
Me-too status (with strength and Qusel tablet 100mg of M/s Hilton Pharma
dosage form)
GMP status Last GMP inspection report dated 06-07-2017
concluding GMP compliance as of today.
Remarks of the Evaluator The official monograph of applied formulation is available in
USP.
56. Name and address of manufacturer / M/s WnsField Pharmaceuticals, Plot No. 122, Block-A, Phase-
Applicant V, Hattar Industrial Estate, Hattar.
Brand Name +Dosage Form + Strength Winbestan Plus tablet
Irbesartan…...........300mg
Hydrochlorothiazide….......12.5mg
Pharmacological Group Angiotensin II receptor blocker/diuretic
Type of Form Form-5
Pack size & Demanded Price As per SRO; As per SRO
Me-too status (with strength and Co-Aprovel of M/s Sanofi Aventis (Pakistan) Ltd.
dosage form)
GMP status Last GMP inspection conducted on 18-01-2018, and the
report concludes that keeping in view of overall GMP
compliance, the panel recommend the Renewal of DML.
Decision: Approved.
57. Name and address of manufacturer / M/s High-Q Pharmaceuticals, Plot No. 224, Sector 23,
Applicant Korangi Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Arolac tablet 10mg
Ketorolac Tromethamine........10mg
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s and 30’s; As per leader price
Me-too status (with strength and Kelac tablet 10mg of M/s Rotex Medica Pakistan Pvt. Ltd
dosage form)
the report shows grant of GMP certificate.
Decision: Approved.
58. Name and address of manufacturer / M/s Nabiqasim industries (Pvt.) Ltd., 17/24, Korangi
Applicant Industrial park, Karachi.
Brand Name +Dosage Form + Strength Neutop 200mg tablets
Topiramate……….200mg
Pharmacological Group Anticonvulsants
Type of Form Form-5
Me-too status (with strength and Tics 200mg tablets of M/s Genix pharma
dosage form)
GMP status Last inspection report 03-08-2017 firm is considered to be
operating at an acceptable level of compliance of GMP
requirements at the time of inspection.
Decision: Approved.
59. Name and address of manufacturer / M/s. Highnoon Laboratories Ltd., 17.5 Km, Multan Road,
Applicant Lahore.
Brand Name +Dosage Form + Strength Biforge 10/320mg tablets
Amlodipine (as besylate)………10mg
Valsartan………………………..320mg
Pharmacological Group Calcium channel blocker/angiotensin II receptor blocker
Type of Form Form-5
Pack size & Demanded Price 14’s; Rs. 500/- 28’s; Rs. 1000/-
Approval status of product in Exforge (USFDA approved)
Me-too status (with strength and Address 10/320 of M/s Scotmann Pharmaceuticals
dosage form)
GMP status Last GMP inspection dated 06-07-2017; firm is considered to be
operating at Good level of compliance of GMP
Decision: Approved.
60. Name and address of manufacturer / M/s Regal Pharmaceuticals (Pvt.) Ltd., Plot No. 2A, St. No. S-
Applicant 5, National Industrial Zone, Rawat, Islamabad.
Brand Name +Dosage Form + Strength Muscosid injection 4mg/2ml
Composition Each 2ml ampoule contains:

Thiocolchicoside….......4mg
Pharmacological Group Skeletal muscle relaxant
Type of Form Form-5
Pack size & Demanded Price 2mlx1’s and 2mlx6’s; As per SRO
Approval status of product in Approved by ANSM France
Me-too status (with strength and Muscoril by Sanofi-aventis Pakistan Limited
dosage form)
GMP status Last inspection report 20-11-2017 firm is operating at a
fair level of cGMP as of today.
 Firm has approved Liquid ampoule (G) sterile section.
61. Name and address of manufacturer / M/s Pacific Pharmaceuticals Limited, 30-Km, Multan Road,
Applicant Lahore.
Brand Name +Dosage Form + Strength Folicon P 5mg tablets
Folic acid........5mg
Pharmacological Group Haematinic
Type of Form Form-5
Pack size & Demanded Price 20’s and 100’s; As per brand leader
Me-too status (with strength and Folimic tablets 5mg of M/s Alliance Pharmaceuticals
dosage form)
GMP status Certificate of cGMP based upon inspection conducted on 22-02-
2018 is submitted.
Decision: Approved.
62. Name and address of manufacturer / M/s Farm Aid Group, Plot #3/2, Phase I & II, Hattar Industrial
Applicant Estate, Haripur.
Brand Name +Dosage Form + Strength Thioside 4mg capsule
Thiocolchicoside ….......4mg
Pharmacological Group Muscle relaxant
Type of Form Form-5
Finished product Specifications Innovator’s specification
Approval status of product in Myoplege (ANSM approved)
Me-too status (with strength and Thiolax capsule by S.J & G Fazul Ellahie
dosage form)
GMP status Firm is cGMP compliant as per inspection conducted on
07-09-2017.
Decision: Approved.
Evaluator PEC-I
63. Name and address of manufacturer M/s Albert Pharma (Pvt) Ltd, Plot no. 127, Sunder Industrial
Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength AURABET Tablets 850mg
Diary No. Date of R& I & fee Diary No:8362, 11-07-2017 , Rs: 20,000/-
Composition Each film coated tablet contains:-
Vildagliptin………50mg
Metformin HCl…..850mg
Pharmacological Group Anti-diabetic
Type of Form Form-5
Finished Product Specification Innovator Specs.
rd
33
Pack size & Demanded Price 3*10’s / As per SRO
Approval status of product in Reference GALVUS MET 50mg/850mg tablets.
Regulatory Authorities. Swiss-Medics Approved.
Me-too status GALVUS MET 50mg/850mg Tablets.
'NOVARTIS Pharma Stein AG, Switzerland. (Reg#066106)
GMP status CLB in its 253rd meeting held on 15th & 16th May 2017, granted
the DML by way of formulation for following sections:-
Tablet General Section
Capsule General Section
Oral Dry powder suspension (General)
Remarks of the Evaluator.
Decision: Approved with Innovator’s specifications and shelf life of 18 months.
64. Name and address of manufacturer M/s Albert Pharma (Pvt) Ltd,
Plot no. 127, Sunder Industrial Estate, Raiwind Road, Lahore.
Vildagliptin……….50mg
Metformin HCl…. 1000mg
Type of Form Form-5
Regulatory Authorities. Swiss-Medics approved.
Me-too status Vildagliptin 50mg + Metformin HCl 1000mg 'NOVARTIS
Pharma Stein AG, Switzerland. (Reg#066107)
Decision: Approved with Innovator’s specifications with a shelf life of 18 months.
Brand Name +Dosage Form + Strength KLARET Tablets 500mg
Clarithromycin…..500mg
Pharmacological Group Anti-biotic
Type of Form Form-5
Finished Product Specification USP Specs.
Approval status of product in Reference US-FDA approved.
Regulatory Authorities.
Me-too status Nycin 500mg Tablet, Ankaz Pharmex (Pvt) Ltd. (Reg#066728)
Decision: Approved with change of brand name
Brand Name +Dosage Form + Strength KLARET Dry Susp. 250mg/5ml
Composition Each 5ml contains:-
Clarithromycin….250mg
Type of Form Form-5
Pack size & Demanded Price 60ml / As per SRO
Me-too status Rithmo 250mg/5ml Dry Suspension,
Sami Pharmaceuticals (PVT) Ltd. (Reg#066900)
Brand Name +Dosage Form + Strength KLARET SR Tablet 500mg
Clarithromycin…..500mg
Type of Form Form-5
Me-too status Larith XL Tablet, Genix Pharma, (Reg#067328)
Decision: Deferred for clarification of applied dosage form whether sustained release or otherwise.
Brand Name +Dosage Form + Strength TRIXIN Tablets 250mg
Naproxen Sodium…. 275mg
Pharmacological Group Analgesic
Type of Form Form-5
Me-too status Sonac 275mg Tablet. (Reg#023066)
Mfd. By; Saydon Pharmaceuticals Industries Ltd.
Decision: Approved.
Brand Name +Dosage Form + Strength TRIXIN Tablets 500mg
Naproxen Sodium…. 550mg
Type of Form Form-5
Me-too status Sonac 550mg Tablet. Mfd. By; Saydon Pharmaceuticals
Industries Ltd. (Reg#023067)
Decision: Approved.
Brand Name +Dosage Form + Strength ARTIMAX-80 Tablets 80/480mg
Artemether………80mg
Lumefeantrine…..480mg
Pharmacological Group Antimalarial
Type of Form Form-5
Finished Product Specification Albert’s Specs.
Approval status of product in Reference WHO Prequalified.
Me-too status Arceva 80/480 Tablet . Mfd. By
SamiPharmaceuticals, (Reg#058381)
Decision: Deferred for the clarification required regarding dosage form as the firm applying for the
film coated tablet while its international status is an uncoated tablet.
Brand Name +Dosage Form + Strength ARTIMAX-20 Tablets 20/120mg
Artemether……..20mg
Lumefeantrine….120mg
Type of Form Form-5
Approval status of product in Reference COARTEM;
Regulatory Authorities. US-FDA Approved.
Me-too status Cibuther 20/120 Tablet.
Mfd. By: Cibex Pharmaceuticals, (Reg#076600)
Brand Name +Dosage Form + Strength ALZERT DS Tablets 10/160
Composition Each tablet contains:-
Amlodipine….10mg
Valsartan…….160mg
Pharmacological Group Anti-Hypertensive.
Type of Form Form-5
Approval status of product in Reference US-FDA Approved
Me-too status Valsat AMD Tablets 10/160mg
Mfd. By: Himont Pharma (Pvt.) Ltd., (Reg#076856)
Decision: Approved.
Brand Name +Dosage Form + Strength ALZERT Tablets 5/80
Amlodipine…..5mg
Valsartan……..80mg
Pharmacological Group Anti-Hypertensive.
Type of Form Form-5
rd
37
Me-too status Valsat AMD Tablets 5/80mg
Mfd. By: Himont Pharma (Pvt.) Ltd., (Reg#076855)
Decision: Approved.
Brand Name +Dosage Form + Strength FOBERT Tablets 40mg
Famotidine…..40mg
Pharmacological Group H2-Antagonist
Type of Form Form-5
Finished Product Specification BP Specs.
Me-too status Fammo 40 mg Tablet
Mfd. By: Mafins Karachi., (Reg#079890)
Decision: Approved.
Brand Name +Dosage Form + Strength FOBERT Tablets 20mg
Famotidine…..20mg
Pharmacological Group H2-Antagonist
Type of Form Form-5
Finished Product Specification BP Specs.
Me-too status Welcid-20mg Tablets; Mfd. By:
Well & Well Pharma (Pvt.) Ltd, (Reg#081681)
Decision: Approved.
Brand Name +Dosage Form + Strength Mecowel 0.5mg Capsule
Composition Each capsule contains:-
Mecobalamin…..0.5mg
Pharmacological Group Co-enzyme- type Vitamin B-12
Type of Form Form-5
Approval status of product in Reference N.A
Me-too status Metran Capsules; Mfd. By:
'Dacwon Pharmaceutica, S.Korea. (Reg#019462)
Remarks of the Evaluator.  Approval status of product in Reference Regulatory
Authorities not confirmed.
Decision: Deferred for evidence of approval of applied formulation in reference regulatory
authorities/agencies which were adopted by the Registration Board in its 275th meeting.
Metformin HCl…..500mg
Type of Form Form-5
Regulatory Authorities. Swiss-Medics approved.
Me-too status GALVUS MET vildagliptin… 50mg
metformin HCl…500mg
'Novartis Pharma Stein AG, Switzerland. (Reg#078106)
Decision: Approved with Innovator’s specifications with a shelf life of 18 months
Brand Name +Dosage Form + Strength AZIRO 250mg Tablet
Azithromycin……250mg
Pharmacological Group Antibiotic
Type of Form Form-5
rd
39
Me-too status A-Mycin Tablets 250 mg; Mfd. By:
Alen Pharmaceuticals (Pvt.) Ltd., (Reg#078510)
Decision: Approved.
Brand Name +Dosage Form + Strength ARTINAC 100mg SR Capsule
Diclofenac Sodium…..100mg
Type of Form Form-5
Approval status of product in Reference MHRA Approved.
Me-too status Diclozet SR 100 Capsule; Mfd. By:
Zeta Pharmaceuticals, Lahore. (Reg#081250)
Decision: Deferred for source of pellets, along with stability studies data, GMP certificate of supplier
and differential fee in case of imported pellets. Registratin Board also directed the firm to clarify the
applied dosage form whether sustained release or otherwise.
Brand Name +Dosage Form + Strength HALT100mg SR tablet
Composition Each enteric coated tablet contains:-
Type of Form Form-5
Approval status of product in Reference MHRA Approved
Me-too status Sintral SR Tablets 100mg; Mfd. By:
Neomedix Pharmaceuticals., ISB (Reg#081413)
Decision: Deferred for the clarification required that the firm applied for SR tablet while in form-5
they have applied for enteric coated tablets.
Brand Name +Dosage Form + Strength HALT50mg tablet
Composition Each enteric coated tablet contains:-
Diclofenac Sodium……50mg
Type of Form Form-5
Me-too status Diclopal Tablet 50mg ; Mfd. By: Palpex Pharma. Kar.
(Reg#082298)
Decision: Deferred for the clarification required that the firm applied for SR tablet while in form-5
they have applied for enteric coated tablets.
Brand Name +Dosage Form + Strength ARTINAC 50mg Capsule
Type of Form Form-5
Me-too status Fesno 50mg Capsule ;
Mfd. By: Adamjee, Karachi. (Reg#081560)
Decision: Approved.
Brand Name +Dosage Form + Strength AZIRO500mg Tablet
Azithromycin as dihydrate…..500mg
Type of Form Form-5
Pack size & Demanded Price 1 * 6’s / As per SRO
Me-too status A-Mycin film coated Tablets 500 mg; Mfd. By:
Alen Pharmaceuticals (Pvt.) Ltd., (Reg#078511)
Decision: Approved.
Brand Name +Dosage Form + Strength ARTIMAX-40Tablets 40/240mg
Artemether………40mg
Lumefeantrine….. 240mg
Type of Form Form-5
Finished Product Specification Int’l Ph. (firm following own specs.)
Pack size & Demanded Price 1 * 8’s / As per SRO
Approval status of product in Reference WHO Prequalified
Me-too status Cibuther DS 40/240 Tablet.
Mfd. By: Cibex Pharmaceuticals, (Reg#076601)
85. Name and address of manufacturer M/s Wellness Pharmaceuticals (Pvt) Ltd,
33, Sunder Industrial Estate, Lahore.
Brand Name +Dosage Form + Strength LETZ Tablets 2.5mg
Letrozole USP…….2.5mg
Pharmacological Group Anti-cancer
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 10’s & 30’s / As per SRO
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 GMP inspection of the firm was conducted on 14-12-2017 by
the panel and concluded in the preliminary report as follows:
“The overall evaluation regarding building,
HVAC, Production, Quality Control, Personnel, Documentation
and Instruments was found Satisfactory on the day of
inspection.”
Remarks of the Evaluator. Application considered on priority as per categories defined by
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
who remain in direct contact or are involved in close handling of these drugs.
Brand Name +Dosage Form + Strength FLUVIR Capsule 75mg
Oseltamivir as phosphate……75mg
Pharmacological Group Antiviral
Type of Form Form-5
Finished product Specification USP
Approval status of product in Reference USFDA approved
Me-too status Tamiflu 75mg capsules of M/s Roche (Reg.#039619)
“The overall evaluation regarding building, HVAC,
Production, Quality Control, Personnel, Documentation and
Instruments was found Satisfactory on the day of inspection.”
Decision: Approved.
Brand Name +Dosage Form + Strength TELBINESS Tablets 600mg
Telbivudine…..600mg
Type of Form Form-5
Pack size & Demanded Price 10’s & 30’s; As per SRO
Me-too status SEBIVO Tablets Mfd. By: Novartis Pharma Stein AG,
(Reg.#047523)
“The overall evaluation regarding building, HVAC, Production,
Quality Control, Personnel, Documentation and Instruments
was found Satisfactory on the day of inspection.”
Decision: Approved.
Evaluator PEC-XIV
88. Name and address of manufacturer / M/s. Kaizen Pharmaceuticals (Pvt.) Ltd; Plot No. E-127, E-128
Applicant & E-129 North Western Industrial Zone, Bin Qasim Karachi
Brand Name +Dosage Form + Strength Urokal Tablet
Composition Each extended release tablet contains
Potassium citrate……………..10mEq
Diary No. Date of R& I & fee 2548, 05-07-2017, 20,000/-, 02-06-2017
Pharmacological Group Urinary Alkalinizing agent
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s; As per PAC
Approval status of product in Reference Urocit-K tablets by Mission Pharma
Regulatory Authorities. (USFDA Approved)
Me-too status Lospin Tablets by Valor Pharmaceuticals
GMP status Copy of GMP inspection report dated 18 & 31-07-2017
recommending renewal of DML.
Decision: Approved.
Brand Name +Dosage Form + Strength Divalpro CR Tablet
Composition Each controlled release Tablet contains:
Divalproex sodium eq. to valproic acid……….500mg
Pharmacological Group Anticonvulsants and anti-epileptics
Type of Form Form-5
Finished product Specification In-house specifications
Approval status of product in Reference Depakote Extended Release tablet of Abbott, USFDA
Me-too status Valprax SR 500mg Tablets of Efroze (Reg#039497)
Brand Name +Dosage Form + Strength Evalpro Tablet
Composition Each Enteric coated Tablet contains:
Sodium valproate ……….200mg
Pharmacological Group Antipsychotic, Anticonvulsants
Type of Form Form-5
Approval status of product in Reference Epilim 200 Gastro-Resistant Tablet of Aventis (MHRA)
Me-too status Valpro Tablets of Saffron Pharma (Reg#046457)
Brand Name +Dosage Form + Strength Dolotec Tablet
Naproxen sodium………….275mg
Type of Form Form-5
Approval status of product in Reference SODEN Naproxen sodium 275mg tablet of southern cross
Regulatory Authorities. pharma, TGA
Me-too status Aproxen sodium tablet of Schazoo (Reg#011702)
92. Name and address of manufacturer / M/s. Jaens Pharmaceutical Industries (Pvt) Ltd. Lahore
Applicant Contract manufactured by M/s. English Pharma, Lahore
Brand Name +Dosage Form + Strength HICIN 4.5GM INJECTION
Composition Each vial contains:-
Sterile Piperacillin sodium eq. to piperacillin……4.0g
Sterile Tazobactam sodium eq. to piperacillin………..0.5g
Diary No. Date of R& I & fee Dy No. 3092; 15-05-2013 Rs.50000/-; 15-05-2013
Pharmacological Group Penicillin Antibiotic
Type of Form Form-5
Approval status of product in Reference Tazocin 4g/0.5g Powder for Solution for Infusion of Pfizer
Regulatory Authorities. Ltd., UK (MHRA)
Me-too status Tazop Injection 4.5g by Global Pharma
GMP status The firm M/s English Pharma was granted GMP certificate
based oninspection dated 16-1-18.
Remarks of the Evaluator. The firm has provided penicillin section (Capsules, Dry
powder suspension, Sterile Dry powder injectable).
Decision: Approved.
93. Name and address of manufacturer / M/s.PharmEvo (Pvt) Limited, Plot# A-29, North Western
Applicant Industrial Zone, Port Qasim Authority, Karachi
Brand Name +Dosage Form + Strength MYEZE 10/40mg TABLET
Ezetimibe…………..10mg
Atorvastatin calcium 43.40mg eq. to Atorvastatin….40mg
Diary No. Date of R& I & fee Dy No. 4254, 29-05-2017 Rs.50000/-; 05-05-2017
Pharmacological Group Lipid Lowering Agent
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s & 30’s; As per PRC
Approval status of product in Reference Liptruzet of MSD, USFDA
Me-too status Atozet 10/40 Tablet of Hilton (Reg#061217)
GMP status Last inspection dated 23-02-2018 confirms that the firm is
operating at an acceptable level of GMP compliance.
Decision: Approved.
Atorvastatin calcium 21.70mg eq. to Atorvastatin……20mg
Type of Form Form-5
Decision: Approved.
Atorvastatin calcium 10.90mg eq. to Atorvastatin……10mg
Type of Form Form-5
Decision: Approved.
96. Name and address of manufacturer / M/s Helix Pharma (Pvt.) Ltd, A-56, Manghopir Road,
Applicant S.I. T.E., Karachi
Brand Name +Dosage Form + Strength ROXAB 10mg Tablet
Rivaroxaban……………..10mg
Pharmacological Group Anticoagulant
Type of Form Form-5
Finished product Specification Manufacturer’s specification
Pack size & Demanded Price 10’s & 14’s: As per PRC
Approval status of product in Reference Xarelto (MHRA approved)
Me-too status Xarelto of M/s Bayer Healthcare
GMP status GMP inspection dated 10-08-2017 and report concludes
satisfactory level of GMP compliance.
Remarks of the Evaluator. The firm had initially applied on Form-5D. Now the firm has
submitted Form-5 for consideration as me-too products
97. Name and address of manufacturer / M/s Helix Pharma (Pvt.) Ltd, A-56, Manghopir Road,
Applicant S.I. T.E., Karachi
Brand Name +Dosage Form + Strength ROXAB 20mg Tablet
Rivaroxaban……………..20mg
Pharmacological Group Anticoagulant
Type of Form Form-5
Pack size & Demanded Price 10’s & 14’s: As per PRC
Approval status of product in Reference Xarelto (MHRA approved)
Me-too status Xarelto of M/s Bayer Healthcare
GMP status GMP inspection dated 10-08-2017 and report concludes
Remarks of the Evaluator. The firm had initially applied on Form-5D. Now the firm has
submitted Form-5 for consideration as me-too products
98. Name and address of manufacturer / M/s Amaan Pharmaceuticals, 30km, Sheikhupura Road
Applicant Lahore.
Brand Name +Dosage Form + Strength KAMENATE INJECTION
Composition Each ml contains:
Dimenhydrinate…………….50mg
Diary No. Date of R& I & fee 14175, 07-09-2017, 20,000/- 06-09-2017
Type of Form Form-5
Finished product Specification In-house
Pack size & Demanded Price 25’s× 1ml ampoules; As per SRO
Approval status of product in Reference Dimenhydrinate Inj of Fresenius kabi, USFDA
Me-too status Corinate 50mg/ml inj of Asian continental (Reg#057863)
GMP status  GMP inspection dated 11-05-2018 concludes that overall
manufacturing facility, equipment/instruments and hygienic
condition of the firm was good. However they are needed
improvements in documentation related to production and
quality control. Firm showed good intention to improve
further.
Applicant Lahore.
Brand Name +Dosage Form + Strength ASOMIDE INJECTION
Furosemide…………..20mg
Pharmacological Group Loop Diuretics
Type of Form Form-5
Pack size & Demanded Price 2ml ampoule× 50’s ; As per SRO
Approval status of product in Reference Furosemide 20mg /2ml solution for Injection (MHRA
Regulatory Authorities. approved)
Me-too status Lasix Inj of Sanofi Aventis (Reg#000230)
further.
Applicant Lahore.
Brand Name +Dosage Form + Strength KAMELAC INJECTION
Ketorolac Trometamol………..30mg
Type of Form Form-5
Pack size & Demanded Price 01ml ampoule × 05’s; As per SRO
Approval status of product in Reference Ketorolac Trometamol solution for injection of Claris
Regulatory Authorities. lifescienes (MHRA approved)
Me-too status Trometh Inj of Nexus Pharma (Reg#055075)
further.
Applicant Lahore.
Brand Name +Dosage Form + Strength KANITAC INJECTION
Ranitidine hydrochloride…………..50mg
Pharmacological Group Antihistamine (H2 receptor antagonist)
Type of Form Form-5
Finished product Specification BP specification
Pack size & Demanded Price 02 ml ampoule ×05’s; As per SRO
Approval status of product in Reference Ranitidine HCl 50mg/2ml solution for Injection (MHRA
Me-too status Ranax injection of StandPharm (Reg#020550)
further.
Decision: Approved.
Evaluator PEC-V
102. Name and address of manufacturer / M/s. Brooks Pharma Private Limited, 58,59 Sector 15, Korangi
Applicant Industrial Area, Karachi
Brand Name +Dosage Form + Strength Incetax Injection 2 g IV
Cefotaxime sodium eq. to cefotaxime…… 2g
Diary No. Date of R& I & fee 14099, 6-09-17, Rs. 20,000/-
Pharmacological Group Third-generation cephalosporin
Type of Form Form 5
Pack size & Demanded Price As per Brand leader
Me-too status Registration Number: 076156
Brand Name: Claforan 2g Injection
Manufacturer Name: M/s Sanofi Aventis
GMP status Last inspection report 11-10-2017 & 16-10-2017 overall GMP
compliance level is satisfactory.(Recommendations)
Remarks of the Evaluator. Firm has relevant section.
Also contains 96 mg (4.18 mmol) of sodium per vial.
Decision: Approved.
103. Name and address of manufacturer / M/s. Brooks Pharma Private Limited, 58,59 Sector 15, Korangi
Brand Name +Dosage Form + Strength Ryxon Injection 2 g (IV)
Ceftriaxone sodium eq. to Ceftriaxone 2g
Pharmacological Group Third-generation cephalosporin
Type of Form Form 5
Pack size & Demanded Price As per Brand leader
Approval status of product in Reference Rocephin( IV/IM) Injection 2gm By M/s Roche Products
Regulatory Authorities. Limited (MHRA approved)
Brand Name: Titan 2gm IV Injection
Manufacturer Name: M/s Macter Pharma
GMP status Last inspection report 11-10-2017 & 16-10-2017 overall GMP
compliance level is satisfactory.(Recommendations)
Remarks of the Evaluator. Firm has relevant section.
Excipient with known effect:
Rocephin contains approximately 83 mg (3.6 mmol) of sodium per
gram of ceftriaxone.
Decision: Approved.
104. Name and address of manufacturer / M/s. Unisa Pharmaceutical Industries Ltd, GT Road Adamzai
Applicant ,Akora Khattak, District Nowshera, KPK
Brand Name +Dosage Form + Strength UNISOL-25 Injection BP
Glucose anhydrous…0.25g
Pharmacological Group Electrolyte with carbohydrate
Type of Form Form 5
Pack size & Demanded Price Polyethylene Ampoule 20ml
As per SRO
Approval status of product in Reference Could not be confirmed
Me-too status Could not be confirmed
GMP status Firm has submitted copy of last inspection conducted on 07-05-
2018 and report concludes good level of cGMP compliance.
Decision: Deferred for the following reasons:
 Evidence of approval of applied formulation in reference regulatory authorities/agencies which
were adopted by the Registration Board in its 275th meeting.
 Evidence of applied formulation/drug already approved by DRAP (generic / me-too status)
alongwith registration number, brand name and name of firm.
105. Name and address of manufacturer / M/s. Mafins Pharma, A-5, S.I.T.E, Super Highway
Brand Name +Dosage Form + Strength Maberol Forte Tablet 650mg+50mg
Paracetamol….650mg
Orphenadrine Citrate…50mg.
Diary No. Date of R& I & fee Dy. No. 2298, 14-11-2016 , Rs.20,000/- (14-11-2016)
Pharmacological Group Muscle Relaxant
Type of Form Form-5
Finished product Specification Manufacturer
Pack size & Demanded Price 10’s
20’s
100’s
Brand Name: Nuberol Forte Tablet
Manufacturer Name: M/s Searle Pakistan Ltd,
GMP status Last GMP Inspection dated 5-10-17 with conclusive remarks of
good cGMP compliance.(Recommendations)
05.10.2017 Follow up (QA & LT status)
Remarks of the Evaluator.  Product is present in USP.
 Evidence of international availability could not be
confirmed.
 Film coating material not provided by the firm.
 Methylene chloride is used which is a banned excipient.
 Evidence of approval of applied formulation in reference regulatory authorities/agencies
 Revision of master formulation mentioning the film coating material of applied formulation.
 Use of alternative solvent as methylene chloride is a banned excipient.
Moreover, Registration Board referred the case to QA & LT Division for updated GMP status.
106. Name and address of manufacturer / M/s Pakistan Pharmaceuticals products (Pvt) Ltd. D- 122,Sindh
Applicant Industries Trading estate, Karachi,
Brand Name +Dosage Form + Strength Telmart Tablets 20mg
Telmisartan …..20mg
Diary No. Date of R& I & fee 18058, 14-09-2017 , Rs.20,000/- (14-09-2017)
Pharmacological Group Antihypertensive
Type of Form Form-5
Pack size & Demanded Price 14’s x 2 blister, As per PRC
Approval status of product in Reference Micardis by Boehringer Ingelheim International GmbH
Regulatory Authorities. (USFDA)
Me-too status Tasmi by Getz Pharma, Karachi (R. No. 047481)
GMP status Last GMP inspection conducted on 12-12-2017 and the report
concludes that firm overall ratings are GOOD.
Evaluation by PEC
Decision: Approved.
Type of Form Form-5
Pack size & Demanded Price 14’s x 2 blister ,As per PRC
concludes that firm overall ratings is GOOD.
Decision: Approved.
Type of Form Form-5
Pack size & Demanded Price 14’s ,As per PRC
concludes that firm overall ratings is GOOD.
Decision: Approved.
Brand Name +Dosage Form + Strength Co-Telmart Tablets 40+12.5mg
Hydrochlorthiazide…..12.5mg
Angiotensin II Receptor Antagonist, Thiazide Diuretic
Type of Form Form-5
Pack size & Demanded Price 14’sx2 blister, As per PRC
Approval status of product in Reference Micardis HCT (USFDA Approved)
Brand Name: Telzimed
Manufacturer Name: Mediate
GMP status 15-12-2016, Recommended GMP certificate issuance.
12.12.2017 No observations. File
Remarks of the Evaluator.  In reference regulatory authorities like in EMA and USFDA
the approved drug is multilayered film coated tablet, while the
applied drug is single layered uncoated tablet.
 Approved in USFDA with box warning.
Warning: Fetal Toxicity
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.
110. Name and address of manufacturer / Genix Pharma (Pvt) Ltd., 44,45-B Korangi Creek Road Karachi
Applicant
Brand Name +Dosage Form + Strength Tiotrol –F Dry Powder Capsule for oral Inhalation
Tiotropium (as bromide monohydrate)…18mcg
Formoterol fumerate (as dihydrate)….12mcg
Pharmacological Group Selective beta 2 adrenergic agonist
Type of Form Form 5
Finished product Specification Innovator
Pack size & Demanded Price 10’s,15’s, 20’s,30’s
Approval status of product in Reference Duova Rotacaps by M/s Cipla Pharmaceuicals, India
Regulatory Authorities. (Not Reference Regulatory Authority)
Brand Name: Tiovair-F Rotacaps
Manufacturer Name: Highnoon Laboratories Ltd,
GMP status Last GMP inspection conducted on 16-02-2018, and the report
concludes that firm is operating at satisfactory level of compliance
of GMP. The management was also suggested to further
strengthen their stability and analytical sections.
Remarks of the Evaluator. Product is not approved by any reference regulatory authority.
111. Name and address of manufacturer / M/s Aspin Pharma Plot # 10- 25, sector 20, Korangi Industrial
Applicant Estate, Karachi
Brand Name +Dosage Form + Strength Taklida 0.1% Ointment
Alternate Names
Takfa
Takroda
Taklima
Tacrolimus (as monohydrate)…1mg (0.1%w/w)
Diary No. Date of R& I & fee Diary No:14319, 8/09/2017, Rs: 20,000/-
Pharmacological Group Agents for dermatitis, excluding corticosteroids
Type of Form Form 5
Finished product Specification Manufacturer’s specifications
Pack size & Demanded Price 10g, 30g, 60g As per SRO
Approval status of product in Reference PROTOPIC (tacrolimus) Ointment 0.1%w/w by M/s LEO
Regulatory Authorities. PHARMA AS (USFDA Approved)
Brand Name: Edtac Ointment 0.1%
Manufacturer Name: Amarant Pharmaceuticals Pvt. Ltd
GMP status Last inspection report 20.02.2018 showing satisfactory GMP
compliance.
Decision: Approved with innovator Specs.
112. Name and address of manufacturer / M/s. Lisko Pakistan (PVT.) LTD.L-10-D, Block No. 21, Shaheed
Applicant Rashid Minhas Road, Federal “B” Industrial Area, Karachi
Brand Name +Dosage Form + Strength Voltrex Plus tablet 50mg+200mcg
Diclofenac sodium….50mg
Misoprostol………0.2mg
Pharmacological Group NSAID/Prostaglandin
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s, 20’s, 28’s, Alu Alu; Rs 50/Tablet
Approval status of product in Reference Approved by MHRA
Brand Name: Prostol Tablets
Manufacturer Name: Flow Pharmaceutical (Pvt) Ltd, 17-KM
Sheikhupura Road, Lahore
GMP status Latest GMP inspection conducted on 24-04-2018 and the report
concludes satisfactory level of GMP compliance.
(Recommendations)
Remarks of the Evaluator.  Approved in USFDA with box warning.
 The formulation contains misoprostol 1% HPMC
dispersion and contains inner enteric coated layer
surrounded by misoprostol dispersion coating and the
method of manufacturing submitted is in line with the
innovator product.
 Evidence of availability of requisite manufacturing
equipment by area FID not provided by the firm.
 Availability of Misoprostol as 1 % HPMC couldnot be
verified from Form 5.
 Evidence of availability of requisite manufacturing equipment by area FID to be provided by
the firm.
 Submission of revised Form 5 mentioning misoprostol as 1 % HPMC dispersion.
 Un-availability of stability chamber for conducting real time stability analysis as per
observations mentioned in inspection report of area FID.
113. Name and address of manufacturer / M/s. Lisko Pakistan (PVT.) LTD.L-10-D, Block No. 21, Shaheed
Brand Name +Dosage Form + Strength Voltrex Plus tablet 75mg+200mcg
Diclofenac sodium….75 mg
Misoprostol………0.2mg
Pharmacological Group NSAID/Prostaglandin
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s, 20’s, 28’s, Alu Alu; Rs 60/Tablet
Approval status of product in Reference USFDA Approved
Brand Name: Cytopan-75 Tablets
Manufacturer Name: Getz Pharma Pakistan (Pvt) Ltd, 30-31/27,
Korangi Industrial Area, Karachi
GMP status
Remarks of the Evaluator. Latest GMP inspection conducted on 24-04-2018 and the report
(Recommendations)
Decision  Approved in USFDA with Box Warning.
 The formulation contains misoprostol 1% HPMC
dispersion and contains inner enteric coated layer
surrounded by misoprostol dispersion coating and the
method of manufacturing submitted is in line with the
innovator product.
 Evidence of availability of requisite manufacturing
equipment by area FID not provided by the firm.
 Availability of Misoprostol as 1 % HPMC could not be
verified from Form 5.
 Evidence of availability of requisite manufacturing equipment by area FID to be provided by
the firm.
 Submission of revised Form 5 mentioning misoprostol as 1 % HPMC dispersion.
114. Name and address of manufacturer / M/s. Lisko Pakistan (PVT.) LTD.L-10-D, Block No.21, Shaheed
Brand Name +Dosage Form + Strength Voltrex SR tablet 100mg
Composition Each sustain release tablet contains:
Diclofenac sodium….100 mg
Acetic acid derivatives and related substances
ATC Code: M01AB05
Type of Form Form-5
Pack size & Demanded Price 10’s, 16’s, 20’s, 30’s, 200’s Alu Alu
Approval status of product in Reference Voltaren-XR
Regulatory Authorities. USFDA Approved
Brand Name: Lisodim S.R tablets
Manufacturer Name: Surge Laboratories (Pvt) Ltd, 10th KM
Faisalabad Road Bikhi District, Sheikhupura
(Recommendations)
Remarks of the Evaluator. Approved in USFDA with box warning.
Decision: Registration Board deferred the case as FID has reported for not having stability chamber
for conducting real time stability analysis.
115. Name and address of manufacturer / M/s. Lisko Pakistan (PVT.) LTD.L-10-D, Block No.21, Shaheed
Brand Name +Dosage Form + Strength Legend Plus Capsule 40mg+1100mg
Omeprazole……………………… 40mg
Sodium Bicarbonate……………1100mg
rd
54
Pharmacological Group Drugs For Peptic Ulcer And Gastro-Oesophageal Reflux Disease
(Gord)
Proton pump inhibitors/Antacid
ATC code: A02BC01
Type of Form Form-5
Brand Name: Zoltar Insta 40mg Capsule
Manufacturer Name: Pharmevo
(Recommendations)
Remarks of the Evaluator. Previously, applied formulation contained omeprazole enteric
coated pellets. Now the firm has replied Omeprazole has been
mistakenly taken as enteric coated pellets and is in the form of
powder.
 Submission of Fee Rs.20,000/- for revision of formulation from enteric coated pellets of
omeprazole to powder.
116. Name and address of manufacturer / M/s. Lisko Pakistan (PVT.) Ltd.L-10-D, Block No.21, Shaheed
Brand Name +Dosage Form + Strength Legend Plus Capsule 20mg+1100mg
Omeprazole……………………… 20mg
Sodium Bicarbonate……………1100mg
Pharmacological Group Drugs For Peptic Ulcer And Gastro-Oesophageal Reflux Disease
(Gord)
Proton pump inhibitors/Antacid
ATC code: A02BC01
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s, 15’s, 7’s, 30’s
Brand Name: Zoltar Insta 20mg Capsule
(Recommendations)
Remarks of the Evaluator. Previously, applied formulation contained omeprazole enteric
coated pellets. Now the firm has replied Omeprazole has been
mistakenly taken as enteric coated pellets and is in the form of
powder.
 Submission of Fee Rs.20, 000/- for revision of formulation from enteric coated pellets of
omeprazole to powder.
117. Name and address of the M/s High-Q plot # 224/23 Korangi Industrial Area, Karachi
manufacturer/Applicant
Brand Name +Dosage Form + Strength Venlaf XR 50mg Tablet
Composition Each Extended Release tablet contains:

Desvenlafaxine (as Succinate)…50mg
Diary No. Date of R&I & Fees Dy No.14331; 08-9-2017, Rs.20,000/-
Pharmacological Group Serotonin-norepinephrine reuptake inhibitor/Antidepressant
Type of Form Form 5
Finish Product Specification Manufacture
Pack size & Demanded price 10’s,14’s,28’s / As per Leader Price
Approval Status of product in Pristiq ER 50mg Tablet
Reference Regulatory Authorities Wyeth Pharms INC, USFDA approved
Me – too Status Registration Number: 080283

Brand Name: Desven XR 50mg Tablet
GMP Status Last GMP inspection of M/s High-Q Pharmaceuticals was
conducted on 19-07-2017 and the report shows grant of GMP
certificate.
Remarks of Evaluator Approved in USFDA with box warning.
Decision: Approved as per Innovator Specifications.
118. Name and address of the M/s High-Q plot # 224/23 Korangi Industrial Area, Karachi
manufacturer/Applicant
Brand Name +Dosage Form + Strength Venlaf XR 100mg Tablet
Composition Each Extended Release tablet contains:

Desvenlafaxine (as Succinate)…100mg
Diary No. Date of R&I & Fees Dy No.14328; 08-9-2017, Rs.20,000/-
Pharmacological Group Serotonin-norepinephrine reuptake inhibitor/Antidepressant
Type of Form Form – 5
Finish Product Specification Manufacture
Pack size & Demanded price 10’s,14’s,28’s / As per Leader Price
Approval Status of product in Pristiq ER 100mg Tablet
Reference Regulatory Authorities Wyeth Pharms INC, USFDA approved
Me – too Status Registration Number: 070760

Brand Name: Desvel XR 100mg Tablet
Manufacturer Name: Hilton
GMP Status Last GMP inspection of M/s High-Q Pharmaceuticals was
certificate.
Remarks of Evaluator Approved in USFDA with box warning.
Decision: Approved as per Innovator Specifications.
119. Name and address of manufacturer / M/s. High-Q Pharmaceuticals, B 64, KDA-1, Karsaz Road,
Applicant Karachi
Brand Name +Dosage Form + Strength Orofit Capsule 120mg
Orlistat…..120mg
Pharmacological Group Peripherally acting antiobesity products
Type of Form Form-5
Pack size & Demanded Price 14’s, As per leader price
Brand Name: Orly Capsules 120 mg
Manufacturer Name: Rotex Medica
GMP status Last GMP inspection of M/s High-Q Pharmaceuticals was
certificate.
Remarks of the Evaluator.  In reference regulatory authority the orlistat is approved
in the form of pellets while the firm has applied for
orlistat in the form of powder.
Decision: Deferred for the submission of Form 5 of applied formulation in line with the innovator
product.
120. Name and address of manufacturer / M/s. High-Q Pharmaceuticals, B 64, KDA-1, Karsaz
Applicant Road, Karachi
Brand Name +Dosage Form + Strength Telmas Tablet (40mg+10mg)
Composition Each bilayer tablet contains:
Amlodipine as besylate…10mg
Pharmacological Group Angiotensin II Receptor Antagonist; Calcium Channel Blocker
Type of Form Form-5
Pack size & Demanded Price 10’s,14’s, 20’s,30’s As per leader price
Approval status of product in Reference Telmisartan and amlodipine 40/10mg Tablet by M/s. Lupin Ltd,
Regulatory Authorities. USA
Brand Name: Amtas Tablet
Manufacturer: M/s Getz Pharma. Karachi.
certificate.
Remarks of the Evaluator.  QC manager signatures on enclosures of Form 5 are not original.
 Brand name resemblance with Telmas of Global Pharma.
 Submission of Form 5 duly signed by QC Manager.
 Evidence of availability of bilayer machine by area FID to be provided by the firm.
Type of Form Form-5
Approval status of product in Reference Telmisartan and amlodipine 80/5mg Tablet by M/s. Lupin Ltd,
Regulatory Authorities. USA
certificate.
Remarks of the Evaluator.  QA manager signatures on enclosures of Form 5 are not original.
Type of Form Form-5
Approval status of product in Reference Telmisartan and amlodipine 40/5mg Tablet by M/s. Lupin
Regulatory Authorities. Ltd,USA.
certificate.
Remarks of the Evaluator.  QA manager signatures on enclosures of Form 5 are not original.
Type of Form Form-5
Approval status of product in Reference Telmisartan and amlodipine 80/10mg Tablet by M/s. Lupin
Regulatory Authorities. Ltd,USA.
certificate.
Remarks of the Evaluator.  QA manager signature on enclosures of Form 5 is not original.
Brand Name +Dosage Form + Strength Telmath Tablet (40mg+12.5mg)
Telmisartan….40mg
Hydrochlorthiazide….12.5mg
Diary No. Date of R& I & fee Dy. No.1375, 24-11-2014 , Rs.20,000/- (23-11-2014)
Pharmacological Group Calcium Antagonist: Diuretic
Type of Form Form-5
Pack size & Demanded Price 10’s,14’s,28’s: As per brand leader
Approval status of product in Reference Micardis HCT USFDA Approved
Brand name: Velmon H
Manufacturer: Martin Dow
certificate.
 Clarification of manufacturing outline as in reference regulatory
authorities the approved drug is multilayered tablet, while the
applied drug is mono layered tablet.
 Clarification of manufacturing outline as in reference regulatory authorities the approved
drug is multilayered tablet, while the applied drug is mono layered tablet.
Brand Name +Dosage Form + Strength Telmath Tablet (80mg+12.5mg)
Telmisartan….80mg
Hydrochlorthiazide….12.5mg
Diary No. Date of R& I & fee Dy. No.1370, 24-11-2014 , Rs.20,000/- (23-11-2014)
Pharmacological Group Calcium Antagonist: Diuretic
Type of Form Form-5
Pack size & Demanded Price 10’s,14’s,28’s: As per brand leader
Approval status of product in Reference Micardis HCT USFDA Approved
Brand name: Velmon H
Manufacturer: Martin Dow
certificate.
 Clarification of manufacturing outline as in reference
regulatory authorities the approved drug is multilayered tablet,
while the applied drug is mono layered tablet.
 Clarification of manufacturing outline as in reference regulatory authorities the approved
drug is multilayered tablet, while the applied drug is mono layered tablet.
Evidence of availability of bilayer machine by area FID to be provided by the firm.
126. Name and address of manufacturer / M/s Nabiqasim Industries (Pvt) Ltd., 17/24, Korangi ,
Applicant Industrial Area, Karachi, Pakistan
Brand Name +Dosage Form + Strength Hypovir Ointment 5%
Diary No. Date of R& I & fee Dy No. 14783: 02-09-2017 PKR 20,000/-02-09-2017
Composition Each g contains:
Acyclovir…..50mg
Type of Form Form 5
Finished Product Specification USP Specs
Pack size & Demanded Price 5g, 10g: As per SRO
Approval status of product in Reference Acyclovir 5% ointment by Tolmar
Brand Name: Acylex 5% ointment
Manufacturer: Ferozsons
GMP status QA Division vide letter No.F.4-4/89-QA dated 18-01-2018
clarified that as per panel Inspection Reports Dated 03-08-2017
and 02-11-2017, the firm Nabiqasim Industries (Pvt). Ltd., Plot
No. 17, Sector 24, Korangi Industrial Area, Karachi was
considered to be operating at acceptable level of compliance of
GMP requirements
Decision: Approved.
127. Name and address of manufacturer / M/s Nabiqasim Industries (Pvt) Ltd., 17/24, Korangi, Industrial
Applicant Area, Karachi, Pakistan
Brand Name +Dosage Form + Strength Hypovir Tablet 200mg
Other Proposed Brand Names
Zovir
Qovir
Alovir
Acyclovir…..200mg
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s: As per SRO
Brand Name: Zoraxin 200mg Tablets
Manufacturer Name: Valor Pharmaceuticals
GMP requirements
Decision: Approved.
Other
Zovir
Qovir
Alovir
Acyclovir…..400mg
Type of Form Form 5
Brand Name: Aclova 400mg Tablets
Manufacturer Name: Akhai Pharmaceutical
GMP requirements
Decision: Approved.
Other
Zovir
Qovir
Alovir
Diary No. Date of R& I & fee Dy No. 14101, 06-09-2017 PKR 20,000/-02-09-2017
Acyclovir….800mg
Type of Form Form 5
Brand Name: Aclova 800mg Tablets
Manufacturer Name: Akhai Pharmaceutical
GMP requirements
Decision: Approved.
Brand Name +Dosage Form + Strength Hypovir Oral Suspension 200mg/5ml
Diary No. Date of R& I & fee Dy No. 15644, 20-09-2017 PKR 20,000/-20-09-2017
Composition Each 5ml of oral suspension contains:
Acyclovir…200mg
Type of Form Form 5
Pack size & Demanded Price 60ml : As per SRO
Approval status of product in Reference Zovirax Suspension 200mg/5ml by M/s Mylan Pharma
Regulatory Authorities. Inc. (USFDA Approved)
Brand Name: Santovir Suspension
Manufacturer Name: Elko Organisation (Pvt) Ltd
GMP requirements
Decision: Approved.
Evaluator PEC-VIII
131. Name and address of manufacturer / M/s. Scilife Pharma Plot No. FD-57/58-A2, Korangi Creek
Applicant Industrial Park, Karachi.
Brand Name +Dosage Form + Strength Zoptra tablet 40mg
Composition Each delayed release tablet contains:
Pantoprazole (as sodium sesquihydrate)………40mg
Diary No. Date of R& I & fee Dy. No.3943; 24-05-2017; Rs.20,000/-
Pharmacological Group PPIs
Type of Form Form-5
Finished product Specifications Manufacturer’s Specifications
Pack size & Demanded Price 14’s, 20’s ; As per SRO
Approval status of product in Reference Approved in US-FDA
Regulatory Authorities
Me-too status (with strength and dosage Cantrofast Tablets 40mg of Candid Pharmaceuticals
form)
GMP status GMP inspection conducted on 05-12-2017 with conclusive
remarks that firm is operating at good level of GMP compliance.
132. Name and address of manufacturer / M/s. Scilife Pharma Plot No. FD-57/58-A2, Korangi Creek
Applicant Industrial Park, Karachi.
Brand Name +Dosage Form + Strength Zoptra tablet 20mg
Pantoprazole (as sodium sesquihydrate)………20mg
Type of Form Form-5
Finished product Specifications Manufacturer’s Specifications
Me-too status (with strength and dosage Cantrofast Tablets 20mg of Candid Pharmaceuticals,
form)
133. Name and address of manufacturer / M/s. Pakistan Pharmaceutical Products (Pvt) Ltd. D-122 Sindh
Applicant Industrial Trading Estate, Karachi.
Brand Name +Dosage Form + Strength Ropinir tablet 0.25mg
Ropinirole (as hydrochloride) ….. 0.25mg
Pharmacological Group Antiparkinson drugs
Type of Form Form-5
Finished product Specifications USP Specifications.
Pack size & Demanded Price 21’s ; Rs. As per PRC
Approval status of product in Reference Requip(Approved in MHRA)
Me-too status (with strength and dosage Balans tablet 0.25mg of Pharm Evo Karachi.
form)
GMP status Certificate of cGMP is issued to the firm based on evaluation
conducted on 21-02-2018.
Remarks of the Evaluator Applicant has revised the formulation from Ropinirole
hydrochloride 0.25mg tablet to Ropinirol (as hydrochloride
monohydrate) 0.25mg film coated tablet which is in line with
innovator product.
Brand Name +Dosage Form + Strength Ropinir tablet 1mg
Ropinirole (as hydrochloride) ….. 1mg
Type of Form Form-5
Pack size & Demanded Price 21’s; Rs. As per PRC
Me-too status (with strength and dosage Balans tablet 1mg of Pharm Evo Karachi.
form)
hydrochloride 1mg tablet to Ropinirol (as hydrochloride
monohydrate) 1mg film coated tablet which is in line with
innovator product.
Brand Name +Dosage Form + Strength Ropinir tablet 2mg
Ropinirole (as hydrochloride) ….. 2mg
Type of Form Form-5
Me-too status (with strength and dosage Balans tablet 1mg of Pharm Evo Karachi.
form)
hydrochloride 2mg tablet to Ropinirol (as hydrochloride
monohydrate) 2mg film coated tablet which is in line with
innovator product.
Brand Name +Dosage Form + Strength Solia tablet 5mg
Solifenacin succinate ….. 5mg
Pharmacological Group Drugs for urinary frequency and incontinence
Type of Form Form-5
Finished product Specifications Manufacturer’s Specifications.
Approval status of product in Reference Vesicare(Approved in US-FDA)
Me-too status (with strength and dosage Solfin Tablet 5 mg of Regal Pharmaceuticals
form)

137. Name and address of Manufacturer / M/s Ameer & Adnan Pharmaceuticals, Raiwind Road, Lahore.
Applicant
Brand Name +Dosage Form +Strength Dantron 4mg/2ml Injection IV
Ondansetron hydrochloride…4mg(2mg/ml)
Diary No. Date of R&I & fee DyNo.280; 06-02-2017; Rs. 20,000/-
Pharmacological Group Antiemetic
Type of Form Form-5
Finished Product Specification USP Specifications
Pack Size & Demanded Price 5’s (2ml); As per SRO
Me-too status Zofran injection 4mg/2mleach 2ml ampoule contains:
4mg ondansetron as ondansetron hydrochloride dehydrate of
GSK
remarks that firm has maintained conformance to cGMP in the
manufacturing and quality control operations on the day of
inspection.
Remarks of Evaluator  In reference agencies applied formulation is approved as
Ondansetron (as hydrochloride dihydrate) 4mg injection
which is different from the applied formulation i.e.
Ondansetron hydrochloride 4mg injection. Submit Form
5, master formulation and manufacturing method in line
with innovator product.
Decision: Deferred for submission of Form 5 in line with reference product i.e. Ondansetron (as
hydrochloride dihydrate) 4mg/2ml injection.
Applicant
Brand Name +Dosage Form +Strength Ademox 400mg/100ml Injection IV
Moxifloxacin hydrochloride…400mg
Type of Form Form-5
Finished Product Specification Manufacturer’s Specifications
Approval status of product in Reference Approved in US-FDA (400mg/250ml)
Me-too status Remox Infusion 400mg/250ml of Regal pharma
inspection.
Remarks of Evaluator  In reference agencies applied formulation is approved as
Moxifloxacin (as hydrochloride) 400mg/250 ml infusion
which is different from the applied formulation i.e.
Moxifloxacin hydrochloride 400mg/100ml infusion. Submit
Form 5, master formulation and manufacturing method in line
 Applied formulation is not present in available USP & BP.
Decision: Deferred for submission of Form 5 in line with reference product i.e. Moxifloxacin (as
hydrochloride) 400mg/250 ml infusion.
Applicant
Brand Name +Dosage Form +Strength Adetol 100mg/2ml Injection IV
Tramadol hydrochloride…100mg(50mg/ml)
Type of Form Form-5
Approval status of product in Reference Approved in MHRA or EMA see
Me-too status Zultra Injection of 100mg/2ml of M/s. Wilshire Laboratories.
inspection.
Remarks of Evaluator Applied formulation is not present in available USP & BP.
140. Name and address of Manufacturer / M/s Ameer & Adnan Pharmaceuticals, Raiwind Road, Lahore..
Applicant
Brand Name +Dosage Form +Strength Sitofor tablet 50/500mg
Sitagliptin(as phosphate monohydrate)…50mg
Metformin hydrochloride…..500mg
Pharmacological Group Dipeptidyl peptidase-4 inhibitor/Biguanide
Type of Form Form-5
Pack Size & Demanded Price 14’s ; As per SRO
Me-too status Glusimet 50mg/500mg Tablet of Opal Lab. Karachi.
inspection.
Remarks of Evaluator  Firm has revised the formulation which is in-line with
reference product.
 Applied formulation is not present in available USP & BP.
Applicant
Brand Name +Dosage Form +Strength Adlevo tablet 500mg
Composition Each film-coated tablet contains:
Levofloxacin(as hemihydrate)…....500mg
Type of Form Form-5
Finished Product Specification USP specifications
Approval status of product in Reference Approved in MHRA
Regulatory Authorities Evoxil 500mg film-coated tablets
Me-too status Lequix tablet 500mg of Schazoo pharmaceuticals
inspection.
Remarks of Evaluator
Applicant
Brand Name +Dosage Form +Strength Adcipro tablet 500mg
Ciprofloxacin(as hydrochloride)…....250mg
Type of Form Form-5
Finished Product Specification USP specifications
Regulatory Authorities Ciproxin 250mgFilm-CoatedTablets by Bayer
Me-too status Ciprobid tablet 250mg of Nova pharmaceuticals
inspection.
143. Name and address of Manufacturer / M/s. Searle IV infusion,1.5 km Raiwind Road, Manga Mandi
Applicant Lahore.
Brand Name +Dosage Form +Strength Nitarains 500mg Tablet
Nitazoxanide….500mg
Diary No. Date of R&I & fee Dy.No.8938; 17-07-2017; Rs. 20,000/-
Pharmacological Group Amebicides
Type of Form Form-5
Finished Product Specification Manufacturer’s specifications
Pack Size & Demanded Price 20’s ; Rs.319/- or as per SRO
Me-too status Nizonide 500mg Tablet of AGP
remarks that firm is GMP compliant.
Remarks of Evaluator Applied formulation is not present in USP & BP.

144. Name and address of Manufacturer / M/s. Searle IV infusion, 1.5 km Raiwind Road, Manga Mandi
Applicant Lahore.
Brand Name +Dosage Form +Strength Tenorains 300mg Tablet
Tenofovir disproxil fumarate….300mg
Pharmacological Group Nucleoside reverse transcriptase inhibitors
Type of Form Form-5
Pack Size & Demanded Price 30’s ; Rs.3450/- or As per SRO
Me-too status Viread 300mg tablet of Ferozsons laboratories limited
remarks that firm is GMP compliant.
Decision: Deferred for correction of label claim as per reference product.
145. Name and address of Manufacturer / M/s. Bloom Pharmaceuticals, Plot # 30, Phase I&II, Industrial
Applicant Estate, Hattar.
Brand Name +Dosage Form +Strength Revel 2mg Tablet
Lorazepam….2mg
Pharmacological Group Benzodiazepine
Type of Form Form-5
Pack Size & Demanded Price 10×10’s ; As per SRO
Me-too status Medi-S 2mg Tablet of Aulton Pharmaceuticals,
remarks that firm is operating at good level of cGMP.
146. Name and address of Manufacturer / M/s. Bloom Pharmaceuticals, Plot # 30, Phase I&II, Industrial
Applicant Estate, Hattar.
Brand Name +Dosage Form +Strength Blotop 50mg Tablet
Itopride hydrochloride….50mg
Pharmacological Group Gastroprokinetic
Type of Form Form-5
Finished Product Specification Manufacturer’s pecifications
Approval status of product in Reference Approved In PMDA
Me-too status Ganaton 50mg Tablet by M/s Abbott. (Reg. # 028429)
remarks that firm is operating at good level of cGMP.
Remarks of Evaluator Applicant has revised the formulation from Itopride (as
hydrochloride) 50mg film coated tablet to Itopride hydrochloride
50mg film coated tablet.
Decision: Approved with innovator’s specification and change of brand name
147. Name and address of Manufacturer / M/s. Saffron Pharmaceuticals, 19 km Sheikhupura Road,
Applicant Faisalabad.
Brand Name +Dosage Form +Strength Safraz 3% w/w topical gel
Diclofenac sodium … 30mg
Type of Form Form-5
Pack Size & Demanded Price 10g, 20g, 50g, 100g; Rs. 70/-,150/-,350/-,700/-,
Me-too status Voltral gel 3% w/w of Novartis pharmaceuticals.
GMP status Certificate of cGMP based on evaluation conducted on 13-10-
2017 is issued to the firm.
Remarks of Evaluator Evidence of Section approval is required.
Decision:Approved with BP specification.
148. Name and address of Manufacturer / M/s. Novamed Pharma, 21 km Ferozepur Road, Lahore.
Applicant
Brand Name +Dosage Form +Strength Novokast 10mg Tablet
Other proposed brand name:
Novokast tablet
Montikast tablet
Leukomed tablet
Montelukast (as sodium ) … 10mg
Type of Form Form-5
Pack Size & Demanded Price 14’s; As per SRO
Me-too status Pulmease 10mg Tablet of Kaizen Karachi.
GMP status GMP inspection conducted on 5th and 27th December 2017 with
conclusive remarks that firm is compliant to good cGMP at the
time of inspection.
Decision:Approved with USP specification.
149. Name and address of manufacturer / M/s.Neutro Pharma, 9.5km Sheikhupura Road, Lahore
Applicant
Brand Name +Dosage Form + Strength Pefol Injection 10mg (IV)(200mg/20ml)
Propofol……….…..10mg
Diary No. Date of R& I & fee Dy.No.5280, 08-06-2017, 20,000/-
Pharmacological Group General anaesthetic
Type of Form Form-5
Pack size & Demanded Price (20ml): As per SRO
Approval status of product in Reference Approved in US-FDA & MHRA(solution for infusion)
Me-too status Propofol 1% injection of M/s Zafa Industries
remarks that firm is operating at fair level of GMP compliance.
Remarks of the Evaluator. Applied formulation is present in BP.
Primary packaging material of applied formulation is LDPE vial
which is not evident in reference agencies.
Reference product is approved in following container closure
system:
(a) Clear neutral glass ampoules of 20 ml.
b) Clear neutral glass vials of 50 ml and 100 ml
c) Type 1 glass pre-filled syringe of 50 ml.
Decision: Deferred for evidence of LDPE vial as primary packaging material of applied formulation
in reference agencies which were adopted by the Registration Board in its 275th meeting or else
submission of stability studies to demonstrate the safety & shelf life of applied formulation in the
intended container closure system.
Applicant
Brand Name +Dosage Form + Strength Uritol 20 Infusion
Mannitol……….…..20gm
Diary No. Date of R& I & fee Dy. No.5260, 08-06-2017, 20,000/-
Pharmacological Group Osmotic diuretic
Type of Form Form-5
Approval status of product in Reference Approved in MHRA (but final volume is 500ml)
Me-too status Medisole-Mannitol of MediPak (pharmaguide)
Remarks of the Evaluator.  Evidence of approval of applied formulation in applied
volume in reference regulatory authorities/agencies
which were declared/approved by the Registration Board
in its 275th meeting.
 Applied formulation is present in BP.
Decision: Deferred for evidence of approval of applied formulation in applied volume i.e. 1000ml in
reference regulatory authorities/agencies which were adopted by the Registration Board in its 275th
meeting.
Applicant
Type of Form Form-5
Approval status of product in Reference Approved in TGA
Me-too status Mannitol infusion of LCPW
Remarks of the Evaluator.  Applied formulation is present in BP.
Applicant
Brand Name +Dosage Form + Strength Nubliz vial 0.5mg/2ml
Composition Each 2ml vial contains:-
Ipratropium bromide(as monohydrate)……….…..0.5mg
Pharmacological Group Anti-muscarinic (bronchodilator)
Type of Form Form-5
Pack size & Demanded Price (2ml vial): As per SRO
Me-too status Atem nebulizer solution of chiesi pharmaceuticals (pvt.) Ltd
Applicant
Brand Name +Dosage Form + Strength Sobid Infusion 10mg/10ml(total vol:100ml)
Isosorbide dinitrate……….…..10mg
Type of Form Form-5
Pack size & Demanded Price (100ml vial): As per SRO
Approval status of product in Reference Approved in MHRA(10ml, 50ml multidose vial)
Me-too status Streight Injection of Werrick Pharmaceuticals(10ml)
Remarks of the Evaluator. Evidence of approval of applied formulation in applied
volume in reference regulatory authorities/agencies which
were declared/approved by the Registration Board in its 275th
meeting.
Evidence of applied formulation/drug in applied volume
already approved by DRAP (generic / me-too status)
Primary packaging material of applied formulation is LDPE
vial which is not evident in reference agencies.
Decision: Deferred for the following:
 Evidence of approval of applied formulation in applied volume in reference regulatory
authorities/agencies i.e. 100ml which were adopted by the Registration Board in its 275th meeting.
 Evidence of applied formulation/drug in applied volume i.e. 100ml already approved by DRAP
(generic / me-too status) alongwith registration number, brand name and name of firm.
 Evidence of LDPE vial as Primary packaging material of applied formulation in reference
agencies which were adopted by the Registration Board in its 275th meeting or else submission of
stability studies to demonstrate the safety of container closure system.
Applicant
Brand Name +Dosage Form + Strength Sobid Infusion 10mg/10ml(total vol:10ml)
Isosorbide dinitrate……….…..10mg
Type of Form Form-5
Pack size & Demanded Price (10mlvial): As per SRO
Approval status of product in Reference Approved in MHRA(10ml ampoule, 50ml multidose vial)
Me-too status Streight Injection of Werrick Pharmaceuticals(10ml)
Remarks of the Evaluator. Primary packaging material of applied formulation is LDPE vial
which is not evident in reference agencies.
Decision: Deferred for evidence of LDPE vial as Primary packaging material of applied formulation
in reference agencies which were adopted by the Registration Board in its 275th meeting or else
submission of stability studies to demonstrate the safety & shelf life of applied formulation in the
intended container closure system.
Applicant
Brand Name +Dosage Form + Strength Uritol 10 Infusion (10%w/v)
rd
71
Type of Form Form-5
Approval status of product in Reference Approved in MHRA (500ml)
Me-too status Mannitol infusion of LCPW
Applicant
Type of Form Form-5
Approval status of product in Reference Approved in MHRA (500ml)
Me-too status Mannitol 20% Injection of international drug agency(500ml)
Applicant
Brand Name +Dosage Form + Strength Neugermina 2billion/5ml
Bacillus claussi……….…..2billion
Pharmacological Group Probiotic/anti-diarrheal
Type of Form Form-5
Pack size & Demanded Price As per SRO
Evidence of approval of applied formulation in applied
were declared/approved by the Registration Board in its 275th
meeting.
Evidence of applied formulation/drug in applied volume
already approved by DRAP (generic / me-too status)
Decision: Registration Board referred the case to Health & OTC division for processing of this
formulation since it contains probiotic.
158. Name and address of Manufacturer / M/s. Welwink Pharmaceuticals, G.T Road Industrail Estate,
Applicant Gujranwala cantt.
Brand Name +Dosage Form +Strength Gantrak tablet 50mg
Clomiphene citrate… 50mg
Pharmacological Group Selective estrogen receptor modulator
Type of Form Form-5
Me-too status Kins Tablets 50mg of Stanley Pharmaceuticals (Pvt) Ltd.
remarks that firm was operating at satisfactory level of GMP
compliance for all sections except liquid injectable section for
which the firm was advised to provide LPC & TOC at the earliest.
Remarks of Evaluator Applied formulation is present in USP.

159. Name and address of manufacturer / M/s Wilshire Laboratories (Pvt) Ltd. 124/1, Quid-e-azam
Applicant Industrial Estate, Kot Lakhpat, Lahore.
Brand Name +Dosage Form + Strength Namsal Injection 0.009g/ml
Diary No. Date of R& I & fee Diary No: 9434: 20-07-17; Rs: 20,000/-
Sodium Chloride…. 0.009gm
Pharmacological Group Electrolyte
Type of Form Form-5
Pack size & Demanded Price 40ml,50ml,100ml ; As per SRO
Me-too status Flow NS IV Infusion Injectable of Mediflow (100ml)
remarks that firm is operating at satisfactory level of GMP
compliance.
Remarks of the Evaluator. Separate application for each volume.
Mention type of primary packaging material.
(Applicant has selected the filled volume “100ml” & type I glass
as container closure system).
Decision: Deferred for confirmation whether manufacturing facility of Liquid injectables is approved
for “ Small Volume Parenterals” or “ Large Volume Parenterals”
Type of Form Form-5
Pack size & Demanded Price 2ml,5ml; As per SRO
Me-too status Engsol Injection 0.90% w/v of English pharma(5ml)
compliance.
Remarks of the Evaluator. Separate application for each applied volume.
(Applicant has selected the filled volume “5ml” & type I glass as
container closure system).
Type of Form Form-5
Pack size & Demanded Price 10ml,20ml; As per SRO
Me-too status Engsol Injection 0.90% w/v of English Pharma(10ml)
compliance.
Remarks of the Evaluator. Separate application for each applied volume.
(Applicant has selected the filled volume “10ml” & type I glass
as container closure system).
162. Name and address of Manufacturer / M/s. Atco laboratories limited, B-18, S.I.T.E., Karachi.
Applicant
Brand Name +Dosage Form +Strength Elvicon Lotion 0.1% w/w
Mometasone furoate… 1mg
Pharmacological Group Corticosteroid
Type of Form Form-5
Pack Size & Demanded Price 10ml, 15ml, 20ml, 30ml, 60ml; Rs. 500/-,750/-,1000/-,1500/-
,3000/-,
Me-too status Santomet lotion of Santé pharmaceuticals.(Pharmaguide)
GMP status Last GMP Inspection conducted on 22-2-2018. GMP certificate
is provided.
Remarks of Evaluator Applied formulation is not present in available USP & BP.
163. Name and address of Manufacturer / M/s Welmark Pharmaceutical Industries (Pvt) Ltd.
Applicant Plot No. 122, Block B, Phase V Industrial Estate, Hattar,
Brand Name +Dosage Form +Strength Noximark tablet 8mg
Lornoxicam ….8mg
Type of Form Form-5
Approval status of product in Reference Approved in Swissmedic
Me-too status Reccam Tablet 8mg Tablet of Regal Pharmaceuticals
GMP status GMP inspection conducted on 16-09-17 with conclusive remarks
that firm is GMP compliant.
Remarks of Evaluator Section approval letter by CLB is required.
164. Name and address of Manufacturer / M/s Welmark Pharmaceutical Industries (Pvt) Ltd. Plot No. 122,
Applicant Block B, Phase V Industrial Estate, Hattar,
Brand Name +Dosage Form +Strength Welproate tablet 250mg
Valproic acid (as divalproex sodium) ….250mg
Pharmacological Group Anti-convulsant
Type of Form Form-5
Approval status of product in Reference Approved in in US-FDA
Remarks of Evaluator Applicant has claimed innovator’s specifications for applied
formulation.
Reference product is approved as Valproic acid (as divalproex
sodium) ….250mg delayed release tablet which is different from
applied formulation, submit form 5, manufacturing method in line
Decision: Deferred for submission of Form 5 in line with reference product i.e. Valproic acid (as
divalproex sodium) 250mg delayed release tablet.
165. Name and address of Manufacturer / M/s Welmark Pharmaceutical Industries (Pvt) Ltd. Plot No. 122,
Applicant Block B, Phase V Industrial Estate, Hattar,
Brand Name +Dosage Form +Strength Welproate tablet 500mg
Valproic acid (as divalproex sodium) ….500mg
Pharmacological Group Anti-convulsant
Type of Form Form-5
Finished Product Specification Innovator’s specifications
Remarks of Evaluator Applicant has claimed innovator’s specifications for applied
formulation.
Reference product is approved as Valproic acid (as divalproex
sodium) ….500mg delayed release tablet which is different from
applied formulation, submit form 5, manufacturing method in line
Decision: Deferred for submission of Form 5 in line with reference product i.e. Valproic acid (as
divalproex sodium) 250mg delayed release tablet.
166. Name and address of Manufacturer / M/s Searl Company Limited F-319 SITE Karachi.
Applicant
Brand Name +Dosage Form +Strength Normal saline Injection (10ml)
Sodium Chloride …90mg
Pharmacological Group Salt solutions
Type of Form Form-5
Pack Size & Demanded Price 1’s, 10’s , 100’s (10ml); As per SRO
Approval status of product in Reference WHO recommended formulation
Me-too status Sacro Injection of Macter Intr. Karachi.
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.
Evaluator PEC-II
167. Name and address of manufacturer / M/s Nabiqasim Industries (Pvt). Ltd.,Karachi
Applicant
Brand Name +Dosage Form + Strength Zudic-HC Cream
Composition Each gm contains:
Fusidic acid ……..20 mg
Hydrocortisone acetate…...10mg
Pharmacological Group Antibiotic/Corticosteroid
Type of Form Form-5
Finished product Specification Manufacturer specifications
Pack size & Demanded Price 5gm, 10gm & 15gm; As per PRC
Approval status of product in Reference Fucidin H cream of M/s LEO Laboratories Limited, approved by
Regulatory Authorities. MHRA of UK
Me-too status Mirazym Cream of M/s Hiranis Karachi (Reg.# 076516)
GMP status --
Remarks of the Evaluator. QA Division vide letter No.F.4-4/89-QA dated 18-01-2018
GMP requirements.
Decision: Approved with innovator’s specifications
168. Name and address of manufacturer / M/s Nabiqasim Industries (Pvt). Ltd., Karachi
Applicant
Brand Name +Dosage Form + Strength Zudic Ointment
Sodium fusidate ……20 mg
Type of Form Form-5
Pack size & Demanded Price 5gm, 10gm & 15gm; As per PRC
Approval status of product in Reference Fucidin ointment of M/s LEO Pharma, approved by TGA of
Regulatory Authorities. Australia
Me-too status ISCORT Ointment of M/s ISIS, Karach (Reg.# 070543)
GMP status --
Remarks of the Evaluator. QA Division vide letter No.F.4-4/89-QA dated 18-01-2018
GMP requirements.
169. Name and address of manufacturer / M/s Amaan Pharma Lahore
Applicant
Brand Name +Dosage Form + Strength Kamebion Injection
Thiamine HCl ……100 mg
Pyridoxine HCl ….. 100 mg
Cyanocobalamin ……. 1000 mcg
Pharmacological Group Vitamin B-compound
Type of Form Form-5
Pack size & Demanded Price 25 x 3ml; 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)
GMP status Last inspection report dated 11-05-2018 concluding that overall
condition of the firm was good.
170. Name and address of manufacturer / M/s Amaan Pharma Lahore
Applicant
Brand Name +Dosage Form + Strength Water for Injection
Composition Each ampoule contains:
Water for injection …… 10 ml
Pharmacological Group Diluent/Vehicle
Type of Form Form-5
Finished product Specification BP
Pack size & Demanded Price 10ml x 100’s; 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)
GMP status Last inspection report dated 11-05-2018 concluding that overall
condition of the firm was good.
Decision: Approved
171. Name and address of manufacturer / M/s Medisynth Pharmaceuticals, Plot No. 55, Street No.S-5,
Applicant National Industrial Zone, Rawat. Contract manufacturing by
M/s EG Pharmaceuticals, Industrial Triangle Kahuta road,
Islamabad.
Brand Name +Dosage Form + Strength Fersyn 100mg/5ml
Iron (III)-hydroxide sucrose complex eq. to elemental Iron…..
100mg
Diary No. Date of R& I & fee Dy. No. 3638; 23-05-2017; Rs.50,000/- (22-05-2017)
Pharmacological Group Iron supplement
Type of Form Form-5
Finished product Specification Manufacturer specification
Approval status of product in Reference Venofer approved by USFDA
Me-too status Venofer I.V. Injection of M/s Gastro Care Karachi (Reg.#023654)
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.
capacity of M/s EG Pharmaceuticals, Industrial Triangle Kahuta road, Islamabad by panel to be
constituted by Chairman Registration Board for further granting contract manufacturing permission
as the firm has already been granted approval for contract manufacturing of numerous products.
Moreover Registration board referred the case to QA & LT Division to conduct GMP inpection of the
M/s EG Pharmaceuticals, Industrial Triangle Kahuta road, Islamabad on priority basis.
172. Name and address of manufacturer / M/s Medisynth Pharmaceuticals, Plot No. 55, Street No.S-5,
Applicant National Industrial Zone, Rawat. Contract manufacturing by
M/s EG Pharmaceuticals, Industrial Triangle Kahuta road,
Islamabad.
Brand Name +Dosage Form + Strength Calmed Injection 5mg/ml
Composition Each ml ampoule contains:
Cholecalciferol…..5mg
Pharmacological Group Vitamin D3 analogue
Type of Form Form-5
Approval status of product in Reference ANSM approved
Me-too status Oral D-3 of M/s Schazoo Pharma
the report concludes that overall firm is operating at reasonable
173. Name and address of manufacturer / M/s EG Pharmaceuticals, Industrial Triangle Kahuta road,
Applicant Islamabad. Contract manufacturing by M/s Bio-Labs (Pvt.)
Ltd., Islamabad
Brand Name +Dosage Form + Strength Lexcid 40mg Injection
Pantoprazole (as sodium) ….. 40mg
Type of Form Form-5
Pack size & Demanded Price As per recommended by PRC
Approval status of product in Reference Pantoprazole 40mg Powder for Solution for Injection or Infusion.
Regulatory Authorities. By M/s TEVA UK Limited (MHRA
Approved)
Me-too status Pazole Dry Powder Injection IV 40mg by M/s Fynk
Pharmaceuticals (Reg#081267)
GMP status M/s Bio-Labs (Pvt.) Ltd., Islamabad was granted GMP
certificate based on inspection conducted on 5th& 06th -12-2017.
Ltd., Islamabad
Brand Name +Dosage Form + Strength Opracid 40mg Injection
Omeprazole (as sodium) ….. 40mg
Type of Form Form-5
Approval status of product in Reference Approved by USFDA
Me-too status RISEK 40MG injection by M/s Julphar Pakistan (Pvt) Ltd
(Reg#045617)
Ltd., Islamabad
Brand Name +Dosage Form + Strength Maxpro 40mg Injection
Esomeprazole (as sodium) ….. 40mg
Type of Form Form-5
rd
79
Me-too status Nexum IV 40mg Injection by M/s Getz Pharma, Karachi,
(Reg#050651).
176. Name and address of manufacturer / M/s Linta Pharmaceuticals (Pvt) Ltd, Plot No.3 Street No.S-5,
Applicant RCCI, Rawat Rawalpindi.
Brand Name +Dosage Form + Strength Zota 50mg Tablets
Sertraline (as hydrochloride) ………….. 50 mg
Diary No. Date of R& I & fee Dy. No. 4083, 21-04-2017, Rs. 20,000/- (19-04-2017)
Pharmacological Group SSRI
Type of Form Form-5
Pack size & Demanded Price As per DRAP policy
Approval status of product in Reference Approved by MHRA of UK
Me-too status Yesme Tablet 50mg by M/s Metro Pharmaceuticals, Islamabad.
(Reg.#081674)
GMP status Last GMP inspection was conducted on 08-06-2017 and the
report concludes firm may be issued GMP certificate.
Remarks of the Evaluator.  Firm has proposed following alternate brand names:
i. Anti-D
ii. Dep-One
iii. Zotra
iv. Lustra
Decision: Approved
Applicant RCCI, Rawat Rawalpindi
Brand Name +Dosage Form + Strength Bina 125mg Tablets
Terbinafine (as hydrochloride) ………….. 125 mg
Pharmacological Group Antifungal
Type of Form Form-5
Me-too status Mycoderm 125mg Tablet by M/s Nabiqasim Karachi
(Reg.#081045)
report concludes firm may be issued GMP certificate.
Remarks of the Evaluator.  Firm has proposed following alternate brand names:
i. Fung
ii. Fugyl
Decision: Approved
178. Name and address of manufacturer / M/s Demont Research Laboratories (Pvt) Ltd, 20-Km, Sharikpur
Applicant Roa, Lahore.
Brand Name +Dosage Form + Strength Lacosta 50mg Tablet
Lacosamide ………….. 50 mg
Pharmacological Group Antiepiletic
Type of Form Form-5
Pack size & Demanded Price 1 x 14’s; As per SRO
Approval status of product in Reference Vimpat 50mg tablet of M/s UCB INC Pharmaceuticals, (USFDA
Regulatory Authorities. Approved)
Me-too status Lalap 50mg tablet of M/s Genix Pharma (Reg. # 070458)
GMP status Last inspection as per cGMP audit proforma dated 23-02-2018 &
26-02-2018 confirms satisfactory level of GMP compliance.
179. Name and address of manufacturer / M/s Demont Research Laboratories (Pvt) Ltd, 20-Km, Sharikpur
Applicant Roa, Lahore.
Brand Name +Dosage Form + Strength Lacosta 100mg Tablet
Lacosamide ………….. 100 mg
Pharmacological Group Antiepiletic
Type of Form Form-5
Approval status of product in Reference Vimpat oral tablet of UCB Inc, USFDA
Me-too status Lacolep tablet of Hilton Pharma (Reg # 073858)
GMP status Last inspection as per cGMP audit proforma dated 23-02-2018 &
26-02-2018 confirms satisfactory level of GMP compliance.
180. Name and address of manufacturer / M/s Lisko Pakistan Pvt Ltd. L-10-D, Block 21, Shaheed Rashid
Applicant Minhas Road, F.B. Industrial Area, Karachi
Brand Name +Dosage Form + Strength Valsart-AM Tablet 10/160mg
Valsartan.....................10mg
Amlodipine as besylate ….... 160mg
Diary No. Date of R& I & fee Dy. No. 13653, 28-08-2017, Rs. 20,000/-
Type of Form Form-5
Approval status of product in Reference Approved by MHRA
Me-too status Exforge by M/s Novartis
Decision: Deferred for clarification of the formulation since the reference product approved by
USFDA is film coated tablet while the applied formulation is uncoated tablet. Moreover, Registration
Board deferred the case as FID has reported for not having stability chamber for conducting Real
time stability studies.
Brand Name +Dosage Form + Strength Glucomin P Tablet
Pioglitazone as HCl...15mg
Metformin…….850mg
Diary No. Date of R& I & fee Dy. No. 13668, 28-08-2017, Rs. 20,000/- 25-08-2017
Pharmacological Group Antihyperlgycemic
Type of Form Form-5
Pack size & Demanded Price 14’s,20,s,28’s
Me-too status Piozer plus tablets byHilton
for conducting Real time stability studies.
Brand Name +Dosage Form + Strength Glucomin P Tablet
Pioglitazone as HCl...15mg
Metformin...500mg
Pharmacological Group Antihyperglycemic
Type of Form Form-5
Pack size & Demanded Price 14’s, 20’s, 28’s
Me-too status Piozer plus tablets byHilton
Brand Name +Dosage Form + Strength Vortox Tablet 10mg
Vortioxetine...10mg
Pharmacological Group Antidepressant
Type of Form Form-5
Pack size & Demanded Price 1 x 14’s
Approval status of product in Reference BRINTELLIX by M/s Lundbeck, Denmark.
Me-too status Not available
Remarks of the Evaluator.  Registration Board in its previous meetings has referred the
case of applied formulation to Legal Affairs Division for
comments regarding patent of Vortioxetine.
Decision: Registration Board referred the case of applied formulation to Legal Affairs Division for
comments regarding patent of Vortioxetine. Moreover, Registration Board deferred the case as FID
has reported for not having stability chamber for conducting Real time stability studies.
Brand Name +Dosage Form + Strength Liskopride Tablet 50mg
Levosulpiride...50mg
Pharmacological Group Antipsychotics
Type of Form Form-5
Approval status of product in Reference Approved by Italy
Me-too status Sulvoric 50mg Tablet of High-Q (Reg # 070485)
Remarks of the Evaluator.  Reference product is available as uncoated tablet
Decision: Deferred for clarification since the reference product is available as un coated tablet while
the applied product is film coated tablet. Moreover, Registration Board deferred the case as FID has
reported for not having stability chamber for conducting Real time stability studies.
Brand Name +Dosage Form + Strength Mypride SR 150mg Tablet
Composition Each film coated sustained release tablet contains:
Itopride HCl.........150mg
Pharmacological Group Prokinetic
Type of Form Form-5
Approval status of product in Reference Not verifiable
Me-too status Itoride SR Tablets of Amarant Karachi (Reg # 073484)
Remarks of the Evaluator.  Evidence of approval of applied formulation in reference
regulatory authorities/agencies which were declared
/approved by the Registration Board in 275th meeting.
authorities/agencies which were adopted by the Registration Board in its 275th meeting. Moreover,
Registration Board deferred the case as FID has reported for not having stability chamber for
conducting Real time stability studies.
Brand Name +Dosage Form + Strength Telsart Plus Tablet 40/12.5mg
Telmisartan...40mg
Hydrochlorothiazide…....12.5mg
Type of Form Form-5
Pack size & Demanded Price 14’s & 28’s
Approval status of product in Reference Approved by MHRA of Uk
Me-too status Velmon-H 40/12.5mg Tablet of M/s Martin Dow Ltd. Karachi
(Reg.#081160)
Brand Name +Dosage Form + Strength Metofen Tablet
Composition Each tablet conatins:
Ibuprofen...200mg
Methocarbamol...500mg
Pharmacological Group NSAIDs
Type of Form Form-5
Approval status of product in Reference --
Me-too status --
regulatory authorities/agencies which were declared/approved
by the Registration Board in its 275th meeting.
 Evidence of applied formulation/drug already approved by
DRAP (generic / me-too status) alongwith registration
number, brand name and name of firm.
Decision: Rejected as the formulation is not present in Reference Regulatory Authorities and not
registered already with DRAP. Moreover firm has not provided safety, efficacy and quality data of
formulation.
188. Name and address of manufacturer / M/s Cirin Pharm, Pv Ltd, Plot No.32/2-A Indus: Estate, Phase-II,
Applicant Hattar
Brand Name +Dosage Form + Strength Nexus 275mg tablet
Naproxen sodium …… 275mg
Type of Form Form 5
Approval status of product in Reference Approved by Health Canada
Me-too status Eziflam Tablet 275 mg by M/s Danas Pharmaceutical (Pvt) Ltd
(Reg. No. 038646)
GMP status Last inspection conducted on 07-05-2018 and report concludes
good level of cGMP compliance.
Decision: Approved
189. Name and address of manufacturer / M/s Cirin Pharm, Pv Ltd, Plot No.32/2-A Indus: Estate, Phase-II,
Applicant Hattar
Brand Name +Dosage Form + Strength Nexus 550mg tablet
Naproxen sodium …… 550mg
Type of Form Form 5
Approval status of product in Reference Approved by Health Canada
Me-too status Eziflam Tablet 550 mg by M/s Danas Pharmaceutical (Pvt) Ltd
(Reg. No. 038647)
good level of cGMP compliance.
Decision: Approved
190. Name and address of manufacturer / M/s Reliance Pharma, Plot No. 8, Street No. S-8, RCCI Industrial
Applicant Estate , Rawat, Islamabad
Brand Name +Dosage Form + Strength Gaba-P 50mg capsule
Pregablin ……50mg
Pharmacological Group Anti-epileptic drug /GABA analogue.
Type of Form Form-5
Pack size & Demanded Price 10’s,14’s,28’s,50’s & 100’s; As per policy of MOH
Me-too status Gabica 50mg Capsule by M/s Getz Pharmaceuticals.
(Reg#048725)
GMP status Latest GMP inspection report conducted on 27-04-2018
Decision: Approved with Ionnovator’s specifications
Brand Name +Dosage Form + Strength Gaba-P 75mg capsule
Pregablin ……75mg
Type of Form Form-5
(Reg#047365)
Brand Name +Dosage Form + Strength Gaba-P 100 mg capsule
Pregablin ……100 mg
Type of Form Form-5
(Reg#047366)
193. Name and address of manufacturer / M/s. Fynk Pharmaceuticals, 19-Km, Ferozepur Road, G.T. Road,
Applicant Kala shah Kaku, Lahore.
Brand Name +Dosage Form + Strength Terbitec 250mg Tablet
Terbinafine as hydrochloride …… 250mg
Diary No. Date of R& I & fee Dy. No. 16324, 27-09-2017; Rs.20,000/- (27-09-2017)
Type of Form Form-5
Pack size & Demanded Price 1 x 10’s; As per PRC
Me-too status Neoterbin Tablets 250mg by M/s Neomedix Pharmaceuticals,
Islamabad. (Reg.# 081411)
GMP status Copy of GMP inspection on 20-09-2017 concluded that
overall condition of the firm is satisfactory.
Decision: Approved
Brand Name +Dosage Form + Strength Terbitec 125mg Tablet
Terbinafine as hydrochloride …… 125mg
Type of Form Form-5
Pack size & Demanded Price 1 x 10’s; As per PRC
Me-too status Mycoderm 125mg Tablet by M/s Nabiqasim Karachi. (Reg.#
081045)
Decision: Approved
Brand Name +Dosage Form + Strength Terbitec 1% w/w cream
Terbinafine hydrochloride …… 1% w/w
Type of Form Form-5
Pack size & Demanded Price 10gm, 15gm, 30gm; As per PRC
Me-too status Bina 1.0% Cream by M/s Linta pharmaceuticals (Pvt) Limited ,
Islamabad (Reg.# 080268)
Remarks of the Evaluator. No USP or BP monograph is available for applied formulation.
Decision: Approved with Innovator’s specifications
196. Name and address of manufacturer / M/s N.S Pharma, Plot no. 576, 577 Sunder Industrial
Applicant Estate, Lahore
Brand Name +Dosage Form + Strength Paramol 1000mg/100ml Infusion
Paracetamol …… 1000 mg
Type of Form Form-5
Me-too status Panam Infusion 1gm by M/s English Pharma. (Reg.# 067999)
GMP status 08-06-2017,
Grant of new DML
Panel recommends grant of new DML.
Remarks of the Evaluator. Firm has approved Liquid Injectable Ampoule / Vial (General)
section
Brand Name +Dosage Form + Strength Rosusid 20mg tablets
Rosuvastatin ….. 20 mg
Pharmacological Group Cholestrol lowering medicine
Type of Form Form-5
Finished product Specification Manufacturer’ s specification
Pack size & Demanded Price 1 x 10’s;As per SRO
Me-too status Rosunext Tablets 20mg by M/s Novamed Pharma.(Reg.# 064848)
GMP status 08-06-2017, Grant of new DML
Brand Name +Dosage Form + Strength Rosusid 10mg tablets
Rosuvastatin ….. 10 mg
Pharmacological Group Cholestrol lowering medicine
Type of Form Form-5
Pack size & Demanded Price 1 x 10’s;As per SRO
Me-too status Rosunext Tablets 10mg by M/s Novamed Pharma.(Reg.# 064847)
Brand Name +Dosage Form + Strength Tramic 250mg/5ml injection
Tranexamic acid ….. 250 mg
Pharmacological Group Haemostatic
Type of Form Form-5
Approval status of product in Reference Approved by PMDA of Japan
Me-too status Tremic-250 Injection by M/s Fynk Pharma. (Reg.# 062677)
section.
Decision: Approved.
Brand Name +Dosage Form + Strength Tramic 500mg/5ml injection
Pharmacological Group Haemostatic
Type of Form Form-5
Me-too status Tremic-500 Injection by M/s Fynk Pharma. (Reg.# 062678)
Grant of new DML
section.
Decision: Approved
Brand Name +Dosage Form + Strength Lincosid 300mg/2ml injection
Lincomycin as hydrochloride ….. 300 mg
Pharmacological Group Lincosamide
Type of Form Form-5
Approval status of product in Reference Approved by TGA of Australia
Me-too status Linkowin Injection by M/s Medicraft Pharma. (Reg.# 056366)
section.
Decision: Approved
Brand Name +Dosage Form + Strength Lincosid 600mg/2ml injection
Lincomycin as hydrochloride ….. 600 mg
Pharmacological Group Lincosamide
Type of Form Form-5
Approval status of product in Reference Approved by TGA of Australia
Me-too status Olinc Inj. 600mg/2ml by M/s Bosch Karachi. (Reg.# 025416)
section.
Decision: Approved
Brand Name +Dosage Form + Strength Xylosid 2% /2ml injection
Lidocaine hydrochloride ….. 40 mg
Pharmacological Group Local anasethetic
Type of Form Form-5
Me-too status Lignox Injection by M/s Novamed Pharma. (Reg.# 076968)
section.
Decision: Approved
Brand Name +Dosage Form + Strength Xylosid 2% /10ml injection
Lidocaine hydrochloride ….. 200 mg
Pharmacological Group Local anasethetic
Type of Form Form-5
Me-too status Anacaine Injection by M/s Akson Pharma. (Reg.# 037614)
section.
Decision: Approved
Brand Name +Dosage Form + Strength Oflosid 200 /100ml infusion
Ofloxacin ….. 200 mg
Pharmacological Group Quinolone
Type of Form Form-5
Me-too status Anacaine Injection by M/s Akson Pharma. (Reg.# 037614)
section.
Brand Name +Dosage Form + Strength Sidzolid 200 /100ml infusion
Linezolid ….. 200 mg
Type of Form Form-5
Me-too status Ecasi by M/s Sami Pharma. (Reg.# 067516)
section.
Brand Name +Dosage Form + Strength Dopasid 200 /5ml injection
Dopmine as hydrochloride….. 200 mg
Pharmacological Group Catecholamine
Type of Form Form-5
Me-too status Dopamine 200mg Injection by M/s LC&PW. (Reg.# 005935)
Grant of new DML
section.
 In contrary to reference product approved by USFDA &
MHRA of UK, which is available as Dopamine
hydrochloride 200mg/5ml, you have applied for Dopamine
“as hydrochloride” equal to Dopamine 200mg/5ml.
Clarification shall be submitted in this regard.
Decision: Deferred for clarification of applied composition as per reference product
Brand Name +Dosage Form + Strength Sidogym sachet
Composition Each sachet contains:
Rice powder ….….. 6gm
Sodium chloride …… 0.35gm
Potassium chloride …… 0.30gm
Sodium citrate ……… 0.58gm
Pharmacological Group Electrolyte solution
Type of Form Form-5
Me-too status Hilyte-R Sachet by M/s Hilton. (Reg.# 073733)
Remarks of the Evaluator. Firm has approved Sachet (General) section.
Brand Name +Dosage Form + Strength Sidocarb 8.4%/50ml Infusion
Sodium bicarbonate ….. 4.2gm
Pharmacological Group Electrolyte solution
Type of Form Form-5
Approval status of product in Reference Approved by health Canada
Me-too status NA-Bicorb Injection 8.4% by M/s Mediceena Pharma Lahore
(Reg.# 023154)
Grant of new DML
Decision: Approved
Brand Name +Dosage Form + Strength Nsline 0.9%/100ml Infusion
Sodium chloride ….. 900mg
Type of Form Form-5
Me-too status Visoline IV Infusion by M/s Vision Pharma Lahore
(Reg.# 078036)
Decision: Approved
211. Name and address of manufacturer / M/s Kaizen Pharmaceuticals Pvt Ltd, Plot No. E-127, E-128 and
Applicant E-129 North Westren Zone, Port Qasim Authority, Karachi.
Brand Name +Dosage Form + Strength Mosapro Tablet
Mosapride citrate ….. 5 mg
Diary No. Date of R& I & fee Initial R&I date; 15-06-2017; Rs.20,000/- (07-06-2017) duplicate
fee challan
Duplicate Dossier: Dy. No. 4063, 12-06-2018
Pharmacological Group Gastroprokinetic agent
Type of Form Form-5
Finished product Specification JP
Pack size & Demanded Price 10’s,20’s30’s;As per SRO
Approval status of product in Reference Approved by PMDA of Japan
Me-too status Mosed 5mg Tablets by M/s Genome pharma. (Reg.# 064011)
GMP status Last GMP inspection was conducted on 31-07-2017 and the report
concludes renewal of DML
Decision: Approved
212. Name and address of manufacturer / M/s Helix A/56, SITE, Mangopir, Karachi
Applicant
Brand Name +Dosage Form + Strength Eplipsa XR Tablets 500mg
Composition Each film coated extended release tablet contains:
Levitiracetam ….. 500 mg
Diary No. Date of R& I & fee Initial R&I date; 27-04-2015; Rs.50,000/- (27-04-2015) duplicate
fee challan
Duplicate Dossier: Dy. No. 19575, 29-05-2018
Pharmacological Group Anticonvulsant & Antiepileptic
Type of Form Form-5D
Pack size & Demanded Price 10’sAs per PRC
Me-too status Elicia ER 500mg Tablet by M/s Martin Dow Ltd. Karachi. (Reg.#
081140)
concludes satisfactory level of GMP compliance
Remarks of the Evaluator. Firm has submitted Form 5 for applied formulation since applied
formulation is available in me-too status.
Decision: Approved
213. Name and address of manufacturer / M/s Bio-Mark Pharmaceuticals. Plot No.527-Sunder Industrial
Brand Name +Dosage Form + Strength Fixo 30mg/5ml Oral Suspensiom
Fexofenadine hydrochloride ….. 30 mg
Type of Form Form-5
Finished product Specification Manufcaturer specs.
Me-too status Telfast Suspension by M/s Sanofi Aventis. (Reg.# 058699)
GMP status Last inspection report dated 10-03-2017 for the Grant of DML.
Panel recommends grant of DML.
Decision: Registration Board referred the case to QA & LT Division to conduct GMP inspection of
firm on priority.
Brand Name +Dosage Form + Strength Vigabact Sachet
Vigabatrin ….. 500 mg
Pharmacological Group Anti-epileptic
Type of Form Form-5
Approval status of product in Approved by USFDA
Reference Regulatory Authorities.
Me-too status Hilgab 500mg Sachet by M/s Hilton. (Reg.# 076337)
Firm on priority.
Brand Name +Dosage Form + Strength Fosfo Sachet
Fosfomycin as trometamol ….. 3gm
Pharmacological Group Anti-bacterial
Type of Form Form-5
Finished product Specification Manufacture specs.
Me-too status Fosib 3gm Sachet by M/s Ciba Pharmaceuticals (Reg.# 081515)
firm on priority.
Brand Name +Dosage Form + Strength CAI 250mg tablets
Acetazolamide ….. 250mg
Pharmacological Group Carbonic anhydrase inhibitor
Type of Form Form-5
Approval status of product in Approved by MHRA of UK
Me-too status Acetamide Tablets of M/s Werrick Pharma. (Reg.#025175)
Firm on priority.
Brand Name +Dosage Form + Strength Malsanil suspension
Sucralfate ….. 1gm
Pharmacological Group Cytoprotective agent
Type of Form Form-5
Me-too status Sucralate Oral Liquid suspension of M/s Regal Pharma
(Reg.#081988)
Firm on priority.
Brand Name +Dosage Form + Strength Mivab 5mg tablet
Ivabradine as HCl ….. 5mg
Pharmacological Group Sinus node inhibitor
Type of Form Form-5
Me-too status Iva Tablet 5 mg of M/s CSH Pharma (Reg.#081685)
Firm on priority.
Brand Name +Dosage Form + Strength Amval 5/160mg tablet
Amlodipine as besilate ….. 5mg
Valsartan ……. 160mg
Pharmacological Group Calcium channel blocker/Angiotensin-II receptor blocker
Type of Form Form-5
Me-too status Exforge Tablet of M/s Novartis Pharma (Reg.#047570)
Firm on priority.
Brand Name +Dosage Form + Strength Amval 5/80mg tablet
Amlodipine as besilate ….. 5mg
Valsartan ……. 80mg
Pharmacological Group Calcium channel blocker/Angiotensin-II receptor blocker
Type of Form Form-5
Me-too status Exforge Tablet of M/s Novartis Pharma (Reg.#047569)
Firm on priority.
Brand Name +Dosage Form + Strength Brexi 20mg tablets
Piroxicam as beta cyclodextrin ………. 20mg
Type of Form Form-5
Approval status of product in Approved by ANSM of France
Me-too status Achway Tablets of M/s Getz Pharma (Reg.#047355)
Firm on priority.
Brand Name +Dosage Form + Strength Tamsu capsule 0.4mg
Tamsulosin as hydrochloride (as extended release pellets)..0.4mg
Source of pellets; M/s Vision Pharmaceuticals, Islamabad
Pharmacological Group 5-alpha reductase inhibitor
Type of Form Form-5
Me-too status M-Sol 0.4mg Capsule of M/s M/s Regal Pharmaceuticals
(Reg.#081977)
firm on priority.
223. Name and address of manufacturer / M/s Venus Pharma Lahore
Applicant
Brand Name +Dosage Form + Strength Formet Tablet
Composition Each Tablet contains:
Fomotidine……….40mg
Pharmacological Group Antipeptic Ulcerant
Type of Form Form 5
Pack size & Demanded Price 1 x 10’s; Rs.210/-
Me-too status Antidine 40mg Tablet by M/s. Mediate Pharmaceuticals, Karachi
(Reg#048700)
GMP status
Remarks of the Evaluator. Clarification is required for applied dosage form as reference
product is available as film coated tablet whereas firm has applied
as uncoated tablet.
Upon communication of above observation firm has submitted
revised formulation for film coated tablets
 Submission of requisite fee for change of formulation
 Registration Board referred the case to QA&LT Division to conduct GMP inspection of Firm on
priority.
Applicant
Brand Name +Dosage Form + Strength Viocam-20 Tablet
Piroxicam……….20mg
Pharmacological Group Antirheumatic
Type of Form Form 5
Pack size & Demanded Price 2 x 10’s; Rs.210/-
Approval status of product in Reference Approved by ANSM of France
Me-too status Oxipro Tablets by M/s Shrooq Pharmaceuticals (Pvt) Ltd.
(Reg#055219)
GMP status GMP certificate issued based upon the evaluation conducted on
18-12-2014.
Remarks of the Evaluator. Clarification is required for applied dosage form as reference
product is available as oro-dispersible tablet whereas firm has
applied otherwise.
Upon communication of above observation firm has submitted
revised Form 5 & master formulation detailed as under:
Each tablet contains:
Piroxicam as beta cyclodextrin …… 20 mg
No USP or BP monograph is available for applied formulation.
 Submission of requisite fee for change of formulation
 Registration Board referred the case to QA & LT Division to conduct GMP inspection of Firm
on priority.
Applicant
Brand Name +Dosage Form + Strength D-Verine Injection
Drotaverine hydrochloride……….40mg
Pharmacological Group Antispasmodic
Type of Form Form 5
Finished product Specification Manufacturers specification
Pack size & Demanded Price 2ml x 25’s; Rs.450/-
Me-too status No-spa by Sanofi aventis
GMP status
Remarks of the Evaluator. Evidence of approval for applied formulation by RRA.
were adopted by the Registration Board in its 275th meeting.
 Registration Board referred the case to QA & LT Division to conduct GMP inspection of Firm
on priority.
Evaluator PEC-VI
226. Name and address of manufacturer / M/s Bosch Pharamceuticals, Karachi
Applicant
Brand Name +Dosage Form + Strength Quinoflox Oral Suspension 500mg/5ml
Composition Each 5ml suspension after reconstitution contains:
Ciprofloxacin……500mg
Pharmacological Group Fluor quinolones
Type of Form Form-5
Finished product Specification Manufacturer’s
Pack size & Demanded Price 100ml, As per PRC
GMP status 21-09-2017
GMP and follow up inspection
Firm is operating at acceptable level of GMP compliance.
Remarks of the Evaluator. Evidence of approval in reference regulatory authorities and
me-too status could not be confirmed
were declared/approved by the Registration Board
Applicant
Ciprofloxacin as HCl……125mg
Type of Form Form-5
Approval status of product in Reference Ciprfloxacin for suspension by M/s Lupin ltd USFDA
Regulatory Authorities. approved.
Me-too status Ciprin 125mg/5ml suspension of M/s Werrick pharmaceuticals
Decision: Approved.
Applicant
Ciprofloxacin……250mg
Type of Form Form-5
Approval status of product in Reference Ciproxin 250 mg/5 ml granules and solvent for oral Suspension
Regulatory Authorities. by M/s Bayer Healthcare, MHRA approved.
Decision: Approved.
229. Name and address of manufacturer / M/s High-Q Pharmaceuticals, Karachi
Applicant
Brand Name +Dosage Form + Strength Tenovir 300mg tablets
Tenofovir Disoproxil fumarate………300mg
Pharmacological Group Acyclic Nuceotide diester analog of adenosine monophosphate
Type of Form Form-5
Finished product Specification IP
Pack size & Demanded Price 1’s, 30’s, As per PRC
Approval status of product in Reference Tenofovir by Teva Pharma
Me-too status Tenofo-B by Getz
certificate.
Decision: Deferred for correction of label claim as per innovator’s product.
230. Name and address of manufacturer / M/s Semos Pharmaceuticals, Karachi
Applicant
Brand Name +Dosage Form + Strength Volnac SR 100mg tablets
Diclofenac Sodium………100mg
Type of Form Form-5
Pack size & Demanded Price 10’s, Rs.70/-
20’s, Rs.140/-
30’s, Rs.210/-
50’s, Rs.350/-
100’s, Rs.700/-
Approval status of product in Reference Voltarol Retard Tablets 100mg by M/s Novartis
Regulatory Authorities. Pharmaceuticals Limited (MHRA Approved)
Me-too status VOLTAREN SR 100 TABLET by M/s CIBA-GEIGY
(Reg#006010)
GMP status Last inspection conducted on 17-10-2017“with good GMP
compliance
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Noul 40mg capsule
Omeprazole (as enteric coated pellets)……40mg
Type of Form Form-5
20’s, Rs.140/-
30’s, Rs.210/-
50’s, Rs.350/-
100’s, Rs.700/-
Approval status of product in Reference Losec 40 mg by by AstraZeneca UK (MHRA approved)
Me-too status Risek 40mg by Getz
compliance
Remarks of the Evaluator. Pellets are obtained from Vision Pharma.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Sebtin 400mg capsule
Gabapentin……400mg
Pharmacological Group Anticonvulsant
Type of Form Form-5
10’s, Rs.210/-
14’s, Rs.294/-
20’s, Rs.420
Approval status of product in Reference Neurontin of ( USFDA approved)
Me-too status Notensil 400mg Capsules of M/s Pulse Pharmaceutical
compliance
Decision: Approved.
Applicant
Type of Form Form-5
10’s, Rs.160/-
14’s, Rs.224/-
20’s, Rs.320
compliance
Decision: Approved.
Applicant
Type of Form Form-5
Pack size & Demanded Price 7’s, Rs.72/- 10’s, Rs.60/-
14’s, Rs.84/- 20’s, Rs.120/-
compliance
Decision: Approved.
235. Name and address of manufacturer / M/s Nabi Qasim Industries Pvt Ltd, Karachi
Applicant
Brand Name +Dosage Form + Strength Transic capsule 250mg
Tranexamic acid…….250mg
Pharmacological Group Haemostatic/Fibrinolytic
Type of Form Form-5
Pack size & Demanded Price 20’s, 30’s, 100’s, As per PRC
Approval status of product in Reference PMDA Japan
Me-too status Trasamin 250mg Capsule by M/s Hilton Pharma
(Reg#006524)
GMP status GMP status Last inspection conducted on 03-08-2017 and 02-
11-2017 reports conclude that firm is found GMP compliant.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Transic capsule 500mg
Tranexamic acid…….500mg
Type of Form Form-5
Finished product Specification Innovator’s Specification
Approval status of product in Reference Could not be confirmed.
Me-too status HAEMIC-500mg by GENIX
Remarks of the Evaluator. Approval status in RRA could not be confirmed.
Applicant
Brand Name +Dosage Form + Strength Prazolin 30mg IV Injection
Lansoprazole…….30mg
Pharmacological Group Proton Pump Inhibitor
Type of Form Form-5
Finished product Specification Innovator’s Specification
Pack size & Demanded Price 1’s, As per PRC
Approval status of product in Reference Prevacid IV Injection, Takeda Pharmaceuticals USA,
Regulatory Authorities. (USFDA approved)
Me-too status Belenz Injection 30mg by M/s Wellborne Pharmachem Hattar.
(Reg#054894)
Decision: Approved.
238. Name and address of manufacturer / M/s Hicon Pharmaceuticals, Hayatabad
Applicant
Brand Name +Dosage Form + Strength Fevromol-C Suspension
Paracetamol…….120mg
Chlorpheniramine Maleate….1mg
Pharmacological Group Anilide and Substituted Alkylamines
Type of Form Form-5
Finished product Specification Mfg
Pack size & Demanded Price 60ml, 90ml, As per SRO
Me-too status Fevernil-C Suspension by Meditech REg # 046391
GMP status GMP status Last inspection conducted on 26-7-2017Overall

the firm is working under satisfactory level of cGMP
Remarks of the Evaluator. Evidence of approval in reference regulatory authorities could
not be confirmed
239. Name and address of manufacturer / M/s Hilton Pharma, Karachi
Applicant
Brand Name +Dosage Form + Strength Qusel Tablet 50mg
Quetiapine Fumarate eq to Quetiapine…..50mg
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s, 20’s, 28’s, 30’s, As per DPC
report concludes satisfactory level of GMP compliance.
Remarks of the Evaluator. Me-too status could not be confirmed
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic
status) alongwith registration number, brand name and name of firm.
240. Name and address of manufacturer / M/s Faas Pharmaceuticals, Karachi
Applicant
Brand Name +Dosage Form + Strength Tramafaas Tablet
Tramadol……37.7mg
Paracetamol…….325mg
Type of Form Form-5
Pack size & Demanded Price 10’s, As per SRO
Me-too status Misadol Plus tablet of M/s Mission pharma
GMP status Routine GMP inspection conducted on 14-07-2017 concluded
that the current level of compliance is rated satisfactory
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Methofaas tablets
Methocarbamol…..400mg
Pharmacological Group Analgesic skeletal muscle relexant
Type of Form Form-5
Pack size & Demanded Price 3x10’s, As per SRO
Remarks of the Evaluator. Evidence of approval in reference regulatory authorities and
me-too status could not be confirmed
 Evidence of applied formulation/drug already approved by DRAP (generic status) alongwith
registration number, brand name and name of firm
were declared/approved by the Registration Board.
Applicant
Brand Name +Dosage Form + Strength Tegtin Plus tablets
Sitagliptin as Phosphate Mnohydrate…….50mg
Metformin HCl…….1000mg
Pharmacological Group Anti-Diabetic
Type of Form Form-5
Approval status of product in Reference Janumet (TGA Approved)
Me-too status Silmax-M 50mg/1000mg tablet of M/s. High-Q
Pharmaceuticals
Applicant
Brand Name +Dosage Form + Strength Thiofaas 4mg capsule
Thiocolchicoside……4mg
Pharmacological Group Skeletal muscle relexant
Type of Form Form-5
Approval status of product in Reference Myoplege 4 mg capsule by Laboratories GENEVRIER SA
Regulatory Authorities. (ANSM approved)
Me-too status Muscor 4mg Capsule by M/s Genome Pharmaceuticals Pvt.
Ltd.(Reg#046466)
Applicant
Brand Name +Dosage Form + Strength Febstat 40mg tablets
Febuxostat……40mg
Pharmacological Group Xanthine Oxidase Inhibitor
Type of Form Form-5
Approval status of product in Reference Uloric 40mg Tablet (USFDA approved)
Me-too status Zurig 40mg tablet of M/s Getz Pharma
Decision: Approved with innovator’s specification
245. Name and address of manufacturer / M/s Searle IV Solutions Pvt Ltd, Lahore
Applicant
Brand Name +Dosage Form + Strength Feromac Injection
Iron Sucrose complex eq to Elemental Iron…….100mg
Pharmacological Group Iroon Replacement Product
Type of Form Form-5
Pack size & Demanded Price 5mlx5’s, Rs.1150/pack
Approval status of product in Reference Venofer Injection by Vifor
Regulatory Authorities. (MHRA Approved)
Me-too status Venofer injection by Gastrocare
GMP status Last GMP inspection was conducted on 27-02-2018, and
report concludes that firm was GMP compliant
Decision: Approved.
246. Name and address of manufacturer / M/s. Lisko Pakistan (PVT.) LTD.L-10-D, Block No.
Applicant 21, Shaheed Rashid Minhas Road, Federal “B”
Industrial Area, Karachi
Brand Name +Dosage Form + Strength Tizin 2mg tablets
Tizanidine as HCl…….2mg
Pharmacological Group Alpha adrenergic agonist
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s, As per SRO
Approval status of product in Reference Tizanidine 2mg uncoated Tablets Actavis UK Ltd (MHRA)
Me-too status Analar by AGP
Routine GMP visit and sampling,Good level
247. Name and address of manufacturer / M/s. Wilshire Laboratories Pvt Ltd, Lahore.
Applicant
Brand Name +Dosage Form + Strength Nolazin 500mg tablet
Ranolazine……..500mg
Pharmacological Group Anti-anginal
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s, 20’s, 30’s, As per SRO
GMP status GMP certificate issued on the basis of inspection conducted
on 26-9-2017
Remarks of the Evaluator. Approval in RRA and me-too status could not be confirmed
alongwith registration number, brand name and name of firm
were declared/approved by the Registration Board.
248. Name and address of manufacturer / M/s. Nabiqasim Industries Pvt Ltd, Karachi contract
Applicant manufacturing from M/s Surge Labs, Sheikhupura
Brand Name +Dosage Form + Strength Transic Injection 500mg
Tranexamic acid……..500mg
Type of Form Form-5
Pack size & Demanded Price 10’sx5ml, As per SRO
Approval status of product in Reference Cyklokapron 500mg Solution for Injection by M/s Pfizer
Regulatory Authorities. Limited (MHRA approved )
Me-too status Traxacid Injection 500mg/5ml by M/s Asian Continental
(Reg#057866)
GMP status Last inspection (Surge) conducted on 09-11-2017 and report
concludes that firm is found at fair level of GMP compliance
Remarks of the Evaluator. Firm has liquid injectable section.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Ondron 4mg tablet
Ondansetron as HCl dihydrate……4mg
Type of Form Form-5
Pack size & Demanded Price 1’s,10’s,12’s, As per Leader Price
Me-too status Oniron 4mg Tablets Reg # 068374
certificate.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Ondron 8mg tablet
Ondansetron as HCl dihydrate……8mg
Type of Form Form-5
Pack size & Demanded Price 1’s,10’s,12’s, As per Leader Price
Approval status of product in Reference MHRA approved
Me-too status Zofran tablet of M/s GSK
certificate.
Decision: Approved.
251. Name and address of manufacturer / M/s Medera Pharmaceuticals, Rawat Pakistan
Applicant
Brand Name +Dosage Form + Strength Terbimed 125mg tablet
Terbinafine as HCl…..125mg
Type of Form Form-5
Pack size & Demanded Price 10’s,As per SRO
Me-too status Funge tablet of Wilshire Pharma (Reg # 040949)
GMP status Last GMP inspection 6-7-2017 The firm is found complying
GMP as of today
252. Name and address of manufacturer / M/s Welmark Pharmaceuticals, Hattar
Applicant
Brand Name +Dosage Form + Strength Atorwell 40mg tablets
Atorvastatin as Calcium trihydrate……40mg
Pharmacological Group HMG-CoA reductase inhibitor for Hypercholesterolemia
Type of Form Form-5
Pack size & Demanded Price As per SRO, As per SRO
Me-too status Torvia 10mg Tablet of PPP Karachi.
GMP status Latest GMP inspection was conducted on 16-09-2017 and the
report concludes the firm to be GMP compliant.
Applicant
Brand Name +Dosage Form + Strength Atorwell 20mg tablets
Atorvastatin as Calcium trihydrate……20mg
Pharmacological Group HMG-CoA reductase inhibitor for Hypercholesterolemia
Type of Form Form-5
Approval status of product in Reference Approved in USFDA
Me-too status Torvia 20mg Tablet of PPP
GMP status Latest GMP inspection was conducted on 16-09-2017 and the
report concludes the firm to be GMP compliant.
Applicant
Brand Name +Dosage Form + Strength Penamin 250mg tablet
Composition Each film coated tablet contains
Penicillamine………250mg
Pharmacological Group Antidote/DMARD
Type of Form Form-5
Approval status of product in Reference Penicillamine 250 mg film-coated tablets by Generics [UK]
Regulatory Authorities. Limited (MHRA)
Me-too status Vistamin by Wilsons, Islamabad (R. No. 008202)
GMP status Latest GMP inspection was conducted on 26-07-2017 overall
firm is working under satisfactory level of cGMP.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Rumalef 20mg tablet
Leflunamide…….20mg
Pharmacological Group DMARD
Type of Form Form-5
Pack size & Demanded Price 2x10’s, 3x10’s, As per SRO
Approval status of product in Reference Arabloc (TGA approved)
Me-too status Zefora 20mg tablets of M/s Global pharma
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Rumalef 10mg tablet
Leflunamide…….10mg
Pharmacological Group DMARD
Type of Form Form-5
Approval status of product in Reference Leflunomide 10 mg Film-coated Tablets (MHRA)
Me-too status Adira of Wilshire
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Eticox 60mg tablet
Etoricoxib…..60mg
Pharmacological Group Antiinflammatory
Type of Form Form-5
Approval status of product in Reference ARCOXIA 60mg Film-Coated Tablets (MHRA approved)
Me-too status Etoricox of KAIZEN PHARMACEUTICALS PVT LTD
258. Name and address of manufacturer / M/s Amaan Pharma,Sheikhupura road, lahore
Applicant
Brand Name +Dosage Form + Strength Amergine Injection IM/IV
Methylergometrine maleate…..0.2mg
Pharmacological Group Uterotonic
Type of Form Form-5
Pack size & Demanded Price 1ml× 50’s; As per SRO
Approval status of product in Reference Methylergonovine Maleate Injection 0.2mg/ml (1ml) by
Regulatory Authorities. American Regent, Inc, USA
Methergine Injection by Novartis Pharma, USA
Me-too status Ergomin Injection 0.2 mg (1ml) Reg # 066614
GMP status Latest GMP inspection was conducted on 11-5-2018 Overall
Manufacturing facility, equipment/instruments and hygienic
condition of the firm was good. However, they are needed
further.
Remarks of the Evaluator. Firm has General Liquid Injectable section, Steroid Liquid
Injectable section and Hormone Liquid Injectable section,
Decision: Approved.
259. Name and address of manufacturer / M/s Werrick Pharmaceuticals, Islamabad
Applicant
Brand Name +Dosage Form + Strength Bud-Air Dry Powder for Inhalation (Capsules)
Budesonide…….200mcg
Formoterol Fumarate as dihydrate……6mcg
Pharmacological Group Corticosteroid and long acting beta2 agonist
Type of Form Form-5
Finished product Specification Innovators
Approval status of product in Reference Symbicort 200/6 Turbohaler, Inhalation Powder by M/s
Regulatory Authorities. AstraZeneca (MHRA Approved)
Me-too status Combivair 200mcg+6mcg Rotacaps by M/s Highnoon
Laboratories Ltd (Reg#054316)
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. Evidence of rotacaps is not found in Reference Regulatory
Authorities. This formulation is available as Symbicort
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.
260. Name and address of manufacturer / M/s Werrick Pharmaceuticals, Islamabad
Applicant
Brand Name +Dosage Form + Strength Rivaxa Tablet 15mg
Rivaroxaban…..15mg
Pharmacological Group Direct Inhibitor of activated factor X
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s, 30’s, As per SRO
Me-too status Xcept of M/s Pharm-evo Pharmaceuticals
GMP status Last inspection report 7-12-2017 Firm was found to be
operating at a very good level of GMP compliance.
261. Name and address of manufacturer / M/s Wenovo Pharmaceuticals, Punjab small Industrial state,
Applicant Taxila, Rawalpindi
Brand Name +Dosage Form + Strength Triwen Tablet
Composition Each sugar coated tablet contains:
Hydrated Phloroglucinol 80mg corresponding to anhydrous
phloroglucinol……62.233mg
Trimethylphloroglucinol….80mg
Type of Form Form-5
Approval status of product in Reference Spasfon tablets (ANSM Approved)
Me-too status Spasfon tablets of M/s Himont
that firm is found complying GMP as of today.
262. Name and address of manufacturer / M/s. Medicraft Pharmaceuticals, 126 B, industrial estate
Applicant Hayatabad, Peshawar
Brand Name +Dosage Form + Strength Clozamed 25mg tablets
Clozapine……..100mg
Pharmacological Group Dibenzodiazeine
Type of Form Form-5
Approval status of product in Reference Denzapine by Britannia
Brand Name: Clozaril Tablets
Manufacturer Name: Sandoz Pharma Ltd
GMP status Last GMP Inspection conducted on 30-1-2018 with conclusive
remarks of cGMP compliance.
Decision: Approved.
Brand Name +Dosage Form + Strength Arizole15mg tablets
Aripiprazole…..15mg
Pharmacological Group Dopamine partial agonist
Type of Form Form-5
Me-too status Aripip 10mg of M/s Pharmatec
Decision: Approved.
Brand Name +Dosage Form + Strength Mebarin 135mg tablets
Mebeverine HCl……135mg
Type of Form Form-5
Me-too status Cisper 135mg tablet of M/s. Cibex Karachi, (Reg.#074878)
Decision: Approved.
265. Name and address of manufacturer / M/s Next Pharmaceutical Products Pvt Ltd, Plot 44 A-B,
Applicant Sundar Industrial Estate, Lahore
Brand Name +Dosage Form + Strength Lovaflox 750mg tablet
Levofloxacin hemihydrate eq to Levofloxacin……750mg
Pharmacological Group Beta Blocking agent
Type of Form Form-5
Approval status of product in Reference Levaquin 750mg tablets of M/s Janssen Pharms approved by
Regulatory Authorities. USFDA
Me-too status Aksolox 750mg Tablet by M/s Akson Pharmaceutical
GMP status 22-2-2018, The panel concluded that the firm was operating
under satisfactory compliance of cGMP on the day of
inspection
Decision: Approved
Type of Form Form-5
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
inspection
Decision: Approved.
Type of Form Form-5
Me-too status Julevo 250mg tablets of M/s Jupiter Pharma
inspection
Decision: Approved.
268. Name and address of manufacturer / M/s Efroze chemical Industries ,Korangi Industrial Are,
Applicant Karachi
Brand Name +Dosage Form + Strength Algaphan Forte Tablet
Paracetamol……650mg
Orphenadrine Citrate……50mg
Pharmacological Group Analgesic and Antipyretic
Type of Form Form-5
Pack size & Demanded Price 15’s. Rs.75/-
Approval status of product in Reference Could not be confirmed in this strength
Me-too status Nuberol Forte tablet of M/s Searle
GMP status 19-3-2018, panel recommends the grant of renewal of the
DML by way of formulation
Remarks of the Evaluator. Fee challan photocopy attached
269. Name and address of manufacturer / M/s Amson vaccines and Pharma Pvt ltd, Khuta road,
Applicant Islamabad
Brand Name +Dosage Form + Strength Mezonate 1gm Injection
Methylprednisolone sodium succinate eq to
methylprednisolone …….1gm
Diary No. Date of R& I & fee Dy. No.881; 28-8-2017, Rs.20,000/- (22-8-2017)
Type of Form Form-5
Approval status of product in Reference Methylprednisolone 1g powder for solution for injection by
Regulatory Authorities. M/s Teva UK Limited (MHRA Approved)
Me-too status Solumedrol injection 1000mg by M/s Pfizer (Reg. No.
005806)
GMP status Issued Certificate of GMP that is based on the inspection
conducted on 13-4-2018. The certificate is valid for one year
remains until 12-4-2019.
Remarks of the Evaluator. Firm has Dry Powder Injection Steroid section.
Decision: Approved.
Applicant Islamabad
Brand Name +Dosage Form + Strength Mezonate 125mg Injection
methylprednisolone…….125mg
Type of Form Form-5
Approval status of product in Reference Methylprednisolone 125 mg powder for solution for injection
Regulatory Authorities. by M/s Teva UK Limited (MHRA Approved)
Me-too status Solumedrol injection 125mg by M/s Pfizer (Reg. No. 000599)
Decision: Approved.
Applicant Islamabad
methylprednisolone …….500mg
Type of Form Form-5
Approval status of product in Reference Methylprednisolone 500 mg powder for solution for injection
Regulatory Authorities. by M/s Teva UK Limited (MHRA Approved)
Me-too status Elcort 500mg Injection by M/s Vision Pharmaceuticals
(Reg#081903)
Decision: Approved.
Applicant Islamabad
methylprednisolone …….40mg
Type of Form Form-5
Approval status of product in Reference Depo-Medrone 40 mg/ml 1ml vial by M/s Pfizer Limited
Me-too status Depo-Medrol Injection 40mg/ml by M/s Pfizer Pakistan Ltd
(Reg#000606)
Decision: Approved.

Applicant
Brand Name +Dosage Form + Strength Esorid 20mg tablet
Composition Each gastric resistant tablet contains:
Esomeprazole(as esomeprazole magnesium
trihydrate)…..20mg
Pharmacological Group PPI
Type of Form Form-5
Pack size & Demanded Price 7’s, 10’s, 14’s, 20’s, 28’s, 30’s, As per SRO
Me-too status Esomperazole 20mg by Webros Pharma Reg No 056835
GMP status Inspection report 19-7-2017 firm was considered to be
operating at satisfactory level of compliance with GMP
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Esorid 40mg tablet
Composition Each gastric resistant tablet contains:
Esomeprazole (as esomeprazole magnesium trihydrate)
…………..40mg
Type of Form Form-5
Me-too status Esomperazole 40mg by Webros Pharma Reg No 056836
operating at satisfactory level of compliance with GMP
Decision: Approved.
Evaluator PEC-XII
275. Name and Address of Manufacturer / M/s Sigma Pharma International (Pvt) Ltd. Plot No. E-50,
Applicant North West Industrial Zone Port Qasim, Karachi.
Brand Name + Dosage Form + Strength Quiq XR 300mg Tablet
Diary No. Date of R & I & fee Diary No:11235, 07/08/2017, Rs: 20,000/-
Composition Each extended release tablet contains:
Quetiapine (as fumarate)…300mg
Pharmacological Group Antipsychotics (Diazepines, oxazepines, thiazepines and
oxepines)
Type of Form Form-5
Pack Size & Demanded Price 1x10’s, 3x10’s/ As per SRO
Approval Status of Product in Reference Quetiapine 300mg film-coated tablets by M/s Actavis Group
Regulatory Authorities. PTC ehf, (MHRA Approved)
Me-too Status Quopine Tablet 300mg by M/s Medisure Laboratories
(Reg#050355)
GMP Status Last Inspection report 15-09-2017 Firm has acceptable level
of GMP.
Remarks of the Evaluator.  Proposed product names:
Quik, Stipen, Taipan.
Decision: Approved.
Brand Name + Dosage Form + Strength Quiq 200mg Tablet
Quetiapine (as fumarate)…200mg
Pharmacological Group Antipsychotics (Diazepines, oxazepines, thiazepines and
oxepines)
Type of Form Form-5
Pack Size & Demanded Price 1x10’s, 3x10’s/ As per SRO
Approval Status of Product in Reference Quetiapine 200mg film-coated tablets by M/s Sandoz Limited,
Me-too Status Quopine Tablet 300mg by M/s Medisure Laboratories
(Reg#050355)
of GMP.
Quik, Stipen, Taipan.
Decision: Approved.
Brand Name + Dosage Form + Strength Ican 30mg Capsule
Composition Each hard gelatin capsule contains:
Enteric coated Pellets of Duloxetine hydrochloride
equivalent to Duloxetine…60 mg
Pharmacological Group Anti-depressants
Type of Form Form-5
Pack Size & Demanded Price 10’s, 2x7’s, 2x10’s /As per SRO
Approval Status of Product in Reference Cymbalta (Duloxetine 30 mg capsule) by M/s Eli Lilly,
Me-too Status Dulan (Duloxetine 30 mg capsule) by M/s Hilton
Pharma.(Reg#055447)
of GMP.
Letgo, Imback, Ynot.
 Source of pellets: Surge Laboratories (Pvt.) Ltd.
Decision: Approved.
Type of Form Form-5
Pack Size & Demanded Price 10’s, 2x7’s, 2x10’s /As per SRO
Pharma.(Reg#055448)
of GMP.
Remarks of the Evaluator.  Proposed product names: Letgo, Imback, Ynot.
Decision: Approved.
Type of Form Form-5
Pack Size & Demanded Price 10’s, 14’s /As per SRO
Pharma.(Reg#055446)
of GMP.
Letgo, Imback, Ynot.
Decision: Approved.
280. Name and Address of Manufacturer / M/s Brookes Pharma, Pvt Ltd, 58 & 59, Sector 15, Korngi
Applicant Industrial Area, Karachi.
Brand Name + Dosage Form + Strength Moxitier IV Infusion 400mg/250ml
Moxifloxacin (as hydrochloride) …400mg
Pharmacological Group Fluoroquinolone
Type of Form Form-5
Finished Product Specification Innovator’s sepcifications.
Pack Size & Demanded Price 1’s /As per SRO
Approval Status of Product in Reference Avelox 400 mg/250 ml solution for infusion by M/s Bayer plc
Me-too Status Avelox Infusion Solution 400mg/250ml by M/s Bayer
Pakistan (Pvt) Ltd. (Reg#030851)
GMP Status Last inspection was conducted on 11.10.2017 & 16-10-2017
and report concludes that firm was considerd to be operating
at satisfactory level of GMP compliance
Decision: Approved
281. Name and Address of Manufacturer / M/s AGP Limited.
Applicant D-109 S.I.T.E, Karachi .
Brand Name + Dosage Form + Strength Cefatim 1000mg Tablets
Cefadroxil (as monohydrate) …1000mg
Pharmacological Group First-generation cephalosporins
Type of Form Form-5
Approval Status of Product in Reference Cefadroxil Mylan 1g Film-coated Tablets by M/s Generics UK
Regulatory Authorities. Ltd. (Sweden Approved)
Me-too Status Duricef Tablets 1gm by M/s Bristol Myers (Reg#010089)
GMP Status GMP inspection conducted on 12-06-2017 of M/s. AGP
Pharmaceuticals rated good level of GMP compliance
Decision: Approved.
Brand Name + Dosage Form + Strength Cefatim 500mg Capsule
Type of Form Form-5
Approval Status of Product in Reference Cefadroxil Mylan 500mg Capsules, hard by M/s Generics UK
Regulatory Authorities. Ltd. (Sweden Approved)
Me-too Status Duricef Tablets 500mg by M/s Bristol Myers (Reg#008013)
Decision: Approved.
Brand Name + Dosage Form + Strength Cefatim Dry Suspension 250mg/5ml
Composition Each 5ml after reconstitution contains:
Type of Form Form-5
Pack Size & Demanded Price 60ml /As per SRO
Approval Status of Product in Reference Cefadroxil 250 mg/5 ml granules for oral suspension by M/s
Regulatory Authorities. Alkaloid-INT d.o.o. (MHRA Approved)
Me-too Status Duricef suspension 250mg/5ml by M/s Bristol Myers
(Reg#010057)
Decision: Approved.
Brand Name + Dosage Form + Strength Cefatim Dry Suspension 125mg/5ml
Type of Form Form-5
Pack Size & Demanded Price 60ml /As per SRO
Approval Status of Product in Reference ORACEFAL 125 mg / 5 ml powder for oral suspension by M/s
Regulatory Authorities. Bristol - Myers Squibb (ANSM Approved)
Me-too Status Evacef Suspension 125mg/5ml by M/s Highnoon
Laboratories, Lahore (Reg#011213)
Decision: Approved.
285. Name and Address of Manufacturer / M/s Aulton Pharmacuticals,
Applicant Plot#84/1, Block-A, Phase 5, Industrial Estate, Hattar.
Brand Name + Dosage Form + Strength Tiagacil dry powder for injection 50mg
Tigecycline …50mg
Pharmacological Group Tetracycline
Type of Form Form-5
Approval Status of Product in Reference Tigecycline 50 mg powder for solution for infusion by M/s
Regulatory Authorities. Generics [UK] Limited (MHRA Approved)
Me-too Status Tygacil Injection 50mg by M/s Wyeth (Reg#045642)
GMP Status Inspection dated 13-02-2018 Routine GMP Inspection Firm is
operating at good level of GMP compliance
Decision: Approved.
286. 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 Alkast Tablet 10mg
Diary No. Date of R & I & fee Diary No:15366 ,25/04/2018, Rs: 20,000/- Duplicate
(Challan#0500044, Dated:02-11-2015)
Composition Each film coated Tablet Contains:
Montelukast(as sodium)…10mg
Pharmacological Group Leukotriene receptor antagonists
Type of Form Form-5
Pack Size & Demanded Price 14’s /As per SRO.
Approval Status of Product in Reference Montelukast film coated tablets 10mg of Apotex Corp.
Me-too Status Montika 10mg film coated tablet of M/s Sami
Pharmaceuticals
GMP Status 13-02-2018, Routine GMP inspection
Good level of GMP compliance
Remarks of the Evaluator.  Firm had applied as plain tablet while approved
formulation in RRA is film coated.
 Firm submitted fee for revision of formulation of Rs.
5000/- Depsoit slip# 0612162 to film coated tablet.
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.
287. Name and Address of Manufacturer / Briell Pharmaceuticals (Pvt.) Ltd,
Applicant 538-C, Sundar Industrial Estate, Lahore
Brand Name + Dosage Form + Strength Irosoft syrup
Composition Each 5ml Contains:
Iron III Hydroxide Polymaltose Complex equivalent to
Elemental Iron…50mg
Folic Acid …0.35mg
Pharmacological Group Haematinic
Type of Form Form-5
Finished Product Specification Manufacturer’s Specification
Pack Size & Demanded Price 120ml / As per SRO
Approval Status of Product in Reference N/A
Me-too Status Ferosoft-FA Syrup by M/s Hilton Pharma (Reg#045110)
GMP Status Last inspection report dated 25-04-2017, the panel
recommended the grant of New DML
Remarks of the Evaluator. GMP inspection older than 1 year.
Shortcoming letter issued on 4th June, 2018.
firm on priority.
288. Name and Address of Manufacturer / Briell Pharmaceuticals (Pvt.) Ltd,
Applicant 538-C, Sundar Industrial Estate, Lahore
Brand Name + Dosage Form + Strength Beldene 20mg Capsule
Composition Each Capsules Contains:
Piroxicam…20mg
Pharmacological Group Antiinflammatory and antirheumatic products, non-steroid
(Oxicams)
Approval Status of Product in Reference Piroxicam 20 mg capsules, hard by M/s Generics [UK] Ltd t/a
Regulatory Authorities. Mylan (MHRA Approved)
Me-too Status Felden by Pfizer
GMP Status Last inspection report dated 25-04-2017, the panel
recommended the grant of New DML
Remarks of the Evaluator. GMP inspection older than 1 year.
Shortcoming letter issued on 4th June, 2018.
Firm on priority.
289. Name and Address of Manufacturer / M/s City Pharmaceutical Laboratories,
Applicant Plot No. 12-A, Sector 5, I-5, New Serveyno-276, Korangi
Industrial Area, Karachi.
Brand Name + Dosage Form + Strength Claz Tablet 250mg
Clarithromycin …250mg
Pharmacological Group Macrolides
Type of Form Form-5
Pack Size & Demanded Price 1x10’s / Rs. 292/-
Approval Status of Product in Reference Clarithromycin 250 mg Film-coated Tablets by M/s TEVA
Regulatory Authorities. UK Limited (MHRA Approved)
Me-too Status Kalarcied 250mg tablet by M/s ABBOTT (Reg#013149)
GMP Status 06-03-2018
Follow up inspection to verify the rectification of last GMP
observations.
GMP observations had been rectified and firm is considered to
be operating at satisfactory level of GMP compliance.
Decision: Approved.
290. Name and Address of Manufacturer / M/s City Pharmaceutical Laboratories, Plot No. 12-A, Sector
Applicant 5, I-5, New Serveyno-276, Korangi Industrial Area, Karachi.
Brand Name + Dosage Form + Strength Rubifin Tablet 100mg
Flurbiprofen …100mg
Pharmacological Group Antiinflammatory and antirheumatic products, non-steroids
(Propionic acid derivatives)
Type of Form Form-5
Approval Status of Product in Reference Froben Tablets 100 mg by M/s Mylan Products Ltd. (MHRA
Me-too Status Froben 100mg tablet by M/s BOOTS (Reg#006904)
observations.
Decision: Approved with change of brand name.
Brand Name + Dosage Form + Strength Maxflo Tablet 400mg
Moxifloxacin (as hydrochloride) …400mg
Pharmacological Group Fluoroquinolones
Type of Form Form-5
Approval Status of Product in Reference Avelox 400 mg film-coated tablets by M/s Mylan Products
Regulatory Authorities. Ltd. (MHRA Approved)
Me-too Status Moxiflox Tablets by M/s Mediceena Pharma (Reg#034453)
observations.
Decision: Approved with innovator’s specification and change of brand name
Brand Name + Dosage Form + Strength Emozolet Tablet 500mg + 400mg
Diloxanide furoate …500mg
Metronidazole …400mg
Pharmacological Group Amoebicide
Type of Form Form-5
Approval Status of Product in Reference Not confirmed.
Me-too Status Dizet DS Tablets by M/s Rasco Pharma (Reg#040184)
observations.
Remarks of the Evaluator.  Approval Status of Product in Reference Regulatory
 Shortcoming letter issued on 1st June, 2018.
Brand Name + Dosage Form + Strength Melogesic Tablet 7.5mg
Meloxicam …7.5mg
(Oxicams)
Type of Form Form-5
Approval Status of Product in Reference Meloxicam 7.5 mg Tablets by M/s TEVA UK Limited
Me-too Status Mevox 7.5mg Tablets by M/s Hilton Pharma (Pvt) Ltd
(Reg#023928)
observations.
Remarks of the Evaluator.  Firm has applied as film coated tablet while approved
product in RRA in plain tablet.
Decision: Deferred for revision of formulation alongwith submission of fee.
Brand Name + Dosage Form + Strength Melogesic Tablet 15mg
Meloxicam …15mg
(Oxicams)
Type of Form Form-5
Pack Size & Demanded Price 1x10’s , Rs. 110/-
Approval Status of Product in Reference Meloxicam 15 mg Tablets by M/s Actavis UK Limited
Me-too Status Mevox 15mg Tablets by M/s Hilton Pharma (Pvt) Ltd
(Reg#023929)
observations.
Remarks of the Evaluator.  Firm has applied as film coated tablet while approved
product in RRA in plain tablet.
Decision: Deferred for revision of formulation alongwith submission of fee.
Brand Name + Dosage Form + Strength Alzero Tablet 5mg
Levocetirizine dihydrochloride …5mg
Pharmacological Group Piperazine derivatives
Type of Form Form-5
Approval Status of Product in Reference Levocetirizine dihydrochloride 5 mg Film-coated Tablets by
Regulatory Authorities. M/s Hexal AG (MHRA Approved)
Me-too Status Scientilla Tablet 5mg by M/s Macter (Reg#048585)
observations.
Decision: Approved.
Brand Name + Dosage Form + Strength Doxin Capsule 100mg
Doxycycline (as hyclate) …100mg
Pharmacological Group Tetracyclines
Type of Form Form-5
Finished Product Specification BP
Approval Status of Product in Reference Doxycycline 100mg Capsules by M/s Hexal AG (MHRA
Me-too Status Vibramycin 100mg capsule by M/s PFIZER (Reg#000456)
observations.
Decision: Approved.
Brand Name + Dosage Form + Strength Uromide Injection 20mg/2ml
Furosemide …20mg
Pharmacological Group High-ceiling diuretics (Sulfonamides, plain)
Type of Form Form-5
Pack Size & Demanded Price 2mlx10’s / Rs. 195.5/-
Approval Status of Product in Reference Furosemide 20mg/2ml Solution for Injection by M/s Mercury
Regulatory Authorities. Pharma International Ltd (MHRA Approved)
Me-too Status Lasix 20mg injection by M/s Hoechst (Reg#000230)
GMP Status 06-03-2018, Follow up inspection to verify the rectification of
last GMP observations.
Decision: Approved.
298. Name and Address of Manufacturer / M/s Cirin Pharmaceuticals Pvt) Ltd,
Applicant 32/2A Phase-III, Industrial Estate, Hattar.
Brand Name + Dosage Form + Strength Effctor Plus Tablet 10mg/320mg/25mg
Diary No. Date of R & I & fee Diary No:4125 ,29/05/2017, Rs: 20,000/-
Amlodipine (as besylate) …10mg
Valsartan …320mg
Hydrochlorothiazide…25mg
Pharmacological Group Dihydropyridine derivatives (amlodipine) combinations with
angiotensin II antagonists, plain (valsartan) and thiazide
diuretics (hydrochlorothiazide)
Type of Form Form-5
Pack Size & Demanded Price 14’s/ As per SRO
Approval Status of Product in Reference EXFORGE HCT 10/320/25 by M/s Novartis Pharmaceuticals
Regulatory Authorities. Australia Pty Limited (TGA Approved)
Me-too Status Tri-Valsan 10/320/25mg Tablet by M/s Hilton Pharma
(Reg#067441)
Panel inspection for grant of cGMP compliance certificate
Firm is operating under good level of cGMP.
Brand Name + Dosage Form + Strength Ziten Met Tablet 50mg/500mg
Sitagliptin (as phosphate monohydrate) …50mg
Metformin hydrochloride …500mg
Pharmacological Group Combinations of oral blood glucose lowering drugs
Type of Form Form-5
Pack Size & Demanded Price 10’s, 14’s, 30’s / As per SRO
Approval Status of Product in Reference JANUMET 50 mg/500 mg film-coated tablet by M/s Merck
Regulatory Authorities. Sharp & Dohme (Australia) Pty Ltd (TGA Approved)
Me-too Status Janumet 50mg/500mg Tablets by M/s Wilshire Laboratories
(Pvt)Ltd (Reg#059951)
Brand Name + Dosage Form + Strength Ziten Met Tablet 50mg/1000mg
Sitagliptin (as phosphate monohydrate) …50mg
rd
124
Type of Form Form-5
Approval Status of Product in Reference JANUMET 50 mg/1000 mg film-coated tablet by M/s Merck
Regulatory Authorities. Sharp & Dohme (Australia) Pty Ltd (TGA Approved)
Me-too Status Janumet 50mg/1000mg Tablets by M/s Wilshire Laboratories
(Pvt)Ltd (Reg#059952)
Brand Name + Dosage Form + Strength Viltin Met Tablet 50mg/ 500mg
Vildagliptin …50mg
Type of Form Form-5
Approval Status of Product in Reference GALVUMET 50mg/ 500mg film-coated tablet by M/s
Regulatory Authorities. Novartis Pharmaceuticals Australia Pty Limited
Me-too Status Galvus Met 50/500mg Tablets by M/s Novartis (Reg#078106)
Type of Form Form-5
Regulatory Authorities. Novartis Pharmaceuticals Australia Pvt Limited
Me-too Status Galvus Met 50/850mg Tablets by M/s Novartis (Reg#066106)
Type of Form Form-5
Regulatory Authorities. Novartis Pharmaceuticals Australia Pty Limited
Me-too Status Galvus Met 50/1000mg Tablets by M/s Novartis
(Reg#066107)
304. Name and Address of Manufacturer / M/s High-Q Pharmaceuticals,
Applicant Plot No. 224, Sector-23, Korangi Industrial Area, Karachi.
Brand Name + Dosage Form + Strength Atasart 16mg Tablet
Candesartan cilexetil …16mg
Pharmacological Group Angiotensin II antagonists, plain
Type of Form Form-5
Finished Product Specification JP
Pack Size & Demanded Price 10’s, 14’s, 20’s, 28’s, 30’s / As per SRO
Approval Status of Product in Reference Amias 16 mg Tablets by M/s Takeda UK Limited (MHRA
Me-too Status Cansar 16mg Tablets by M/s Pharmatec (Reg#033683)
GMP Status Last GMP inspection conducted on 19-07-2017 and the report
concludes good level of GMP compliance.
Decision: Approved.
Brand Name + Dosage Form + Strength Atasart 32mg Tablet
Candesartan cilexetil …16mg
Pharmacological Group Angiotensin II antagonists, plain
Type of Form Form-5
Approval Status of Product in Reference Amias 16 mg Tablets by M/s Takeda UK Limited (MHRA
Me-too Status Cansar 32mg Tablets by M/s Pharmatec (Reg#035902)
Decision: Approved.
Brand Name + Dosage Form + Strength Mebever 135mg Tablet
Mebeverine hydrochloride …135mg
Pharmacological Group Synthetic anticholinergics, esters with tertiary amino group
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 Colofac Tablets 135 mg by M/s Mylan Products Ltd. (MHRA
Me-too Status MEBEVERINE FORTE TRENKER TAB by M/s FAZUL
ELLAHIE (Reg#011166)
Remarks of the Evaluator.  Firm has applied as plain tablet while approved
formulation is RRA is sugar coated.
Brand Name + Dosage Form + Strength Co-Mesart 20mg+5mg Tablet
Olmesartan medoxomil …20mg
Amlodipine as besilate …5mg
Pharmacological Group Angiotensin II antagonists and calcium channel blockers
Type of Form Form-5
Approval Status of Product in Reference Olmesartan medoxomil/Amlodipine 20 mg/5 mg film-coated
Regulatory Authorities. tablets by M/s Accord Healthcare Limited (MHRA Approved)
Me-too Status Comcarb 5/20mg tablet by M/s Maple Pharmaceuticals (Pvt)
Ltd (Reg#061881)

Amlodipine (as besilate) …10mg
Type of Form Form-5
Approval Status of Product in Reference Not confirmed
Ltd (Reg#061883)
Type of Form Form-5
Approval Status of Product in Reference Sevikar 40 mg/5 mg film-coated tablets by M/s Daiichi
Regulatory Authorities. Sankyo UK Ltd (MHRA Approved)
Ltd (Reg#061882)
Type of Form Form-5
Approval Status of Product in Reference Sevikar 40 mg/10 mg film-coated tablets by M/s Daiichi
Regulatory Authorities. Sankyo UK Ltd (MHRA Approved)
Ltd (Reg#061878)
Brand Name + Dosage Form + Strength Mesart Plus 20mg+12.5mg Tablet
Hydrochlorthiazide …12.5mg
Pharmacological Group Angiotensin II antagonists and diuretics
Type of Form Form-5
Approval Status of Product in Reference Olmesartan Medoxomil/Hydrochlorothiazide 20 mg/12.5 mg
Regulatory Authorities. Film-Coated Tablets by M/s TEVA UK Limited (MHRA
Approved)
Me-too Status Orion DIU 20/12.5 Tablets by M/s Ferozsons Laboratoires
(Reg#052583)
Brand Name + Dosage Form + Strength Mesart Plus 40mg+12.5mg Tablet
Hydrochlorthiazide …12.5mg
Type of Form Form-5
Approval Status of Product in Reference Davidol 40 mg/12.5 mg film-coated tablets by M/s
Regulatory Authorities. Substipharm Developpement (MHRA Approved)
Me-too Status Orion DIU 40/12.5 Tablets by M/s Ferozsons Laboratoires
(Reg#052584)
313. Name and Address of Manufacturer / M/s High-Q Pharmaceuticals, Plot No. 224, Sector-23,
Brand Name + Dosage Form + Strength Mesart Plus 20mg+25mg Tablet
Hydrochlorthiazide …25mg
Type of Form Form-5
Approval Status of Product in Reference Davidol 20 mg /25 mg film-coated tablets by M/s Substipharm
Regulatory Authorities. Developpement (MHRA Approved)
Me-too Status Orion DIU 20/25 Tablets by M/s Ferozsons Laboratoires
(Reg#052585)
314. Name and Address of Manufacturer / M/s High-Q Pharmaceuticals, Plot No. 224, Sector-23,
Brand Name + Dosage Form + Strength Irbesar Plus 300mg+12.5mg Tablet
Irbesartan …300mg
Hydrochlorothiazide …12.5mg
Type of Form Form-5
Approval Status of Product in Reference Irbesartan and Hydrochlorothiazide 300mg / 12.5mg Film-
Regulatory Authorities. coated tablets by M/s Crescent Pharma Limited (MHRA
Approved)
Me-too Status
Decision: Approved.
Brand Name + Dosage Form + Strength Irbesar Plus 300mg+25mg Tablet
Irbesartan …300mg
Hydrochlorothiazide …25mg
Type of Form Form-5
Approval Status of Product in Reference Irbesartan and Hydrochlorothiazide 300mg / 25mg Film-
Approved)
Me-too Status Co-Irba 300/25mg Tablet by M/s Hilton Pharma (Pvt.)
Limited (Reg#058040)
Decision: Approved.
Brand Name + Dosage Form + Strength Irbesar Plus 150mg+12.5mg Tablet
Irbesartan …150mg
Hydrochlorothiazide …12.5mg
Type of Form Form-5
Approval Status of Product in Reference Irbesartan and Hydrochlorothiazide 150mg / 12.5mg Film-
Approved)
Me-too Status Arbi-D 300/12.5 Tablet by M/s Pharmevo (Reg#073771)
Decision: Approved.
Brand Name + Dosage Form + Strength Drota 80mg Tablet
Drotaverine …80mg
Pharmacological Group Drugs for functional gastrointestinal disorders (Papaverine and
derivatives)
Type of Form Form-5
Approval Status of Product in Reference Approved by 3 EMA member states i.e.Lithuania,
Regulatory Authorities. Hungary, Latvia.
Me-too Status No-Spa Forte 80mg Tablet by M/s. Sanofi Aventis
(Reg#029431)
Brand Name + Dosage Form + Strength Spadix 80mg+80mg Tablet
Phloroglucinol hydrate …80mg Trimethylphloroglucinol
…80mg
Pharmacological Group Other drugs for functional gastrointestinal disorders
Type of Form Form-5
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)
Remarks of the Evaluator.  Firm has applied as plain tablet whereas reference product
is approved as sugar coated tablet.
Brand Name + Dosage Form + Strength Zyto 250mg Tablet
Azithromycin (as dihydrate)…250mg
Pharmacological Group Macrolide Antibiotic
Type of Form Form-5
Approval Status of Product in Reference Azithromycin 250 mg Film-Coated Tablets by M/s TEVA UK
Me-too Status Dalemycin 250mg Tablet by M/s Oakdale Pharma
(Reg#079380)
Decision: Approved.
Brand Name + Dosage Form + Strength Ezesel 10mg+10mg Tablet
Atorvastatin …10mg
Ezetimibe …10mg
Pharmacological Group HMG CoA reductase inhibitors in combination with other lipid
modifying agents
Type of Form Form-5
Approval Status of Product in Reference ATOZET 10 mg/10 mg, film-coated tablets by M/s TEVA UK
Me-too Status Zetab Plus Tablet by M/s Schazoo Laboratories (Reg#046244)
Remarks of the Evaluator.  Firm has applied as Atorvastatin base while approved
formulation in MHRA has Atorvastatin (as calcium
trihydrate).
Decision: Deferred for submission of fee for revision of formulation
321. Name and Address of Manufacturer / M/s Wilson’s Pharmaceuticals,
Applicant 387-388, I-9, Industrial Area, Islamabad.
Brand Name + Dosage Form + Strength Oxaban Tablets 20mg
Rivaroxaban …20mg
Pharmacological Group Antithrombotic agents (Direct factor Xa inhibitors)
Type of Form Form-5
Approval Status of Product in Reference Rivaroxaban Sandoz 20 mg Film-coated Tablets y M/s Sandoz
Me-too Status Xarelto 20mg Tablets by M/s Bayer (Reg#072550)
GMP Status Last inspection report conducted on 24-01-2018 concluding a
very good level of GMP compliance.

Brand Name + Dosage Form + Strength Oxaban Tablets 15mg
Rivaroxaban …15mg
Pharmacological Group Antithrombotic agents (Direct factor Xa inhibitors)
Type of Form Form-5
Approval Status of Product in Reference Rivaroxaban Sandoz 15 mg Film-coated Tablets y M/s Sandoz
Me-too Status Xarelto 15mg Tablets by M/s Bayer (Reg#072549)
GMP Status Last inspection report conducted on 24-01-2018 concluding a
very good level of GMP compliance.
Brand Name + Dosage Form + Strength Wilpium 18mcg Rotacaps
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 5’s, 30’s, 90’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 Last inspection report conducted on 24-01-2018 concluding
a very good level of GMP compliance.

Brand Name + Dosage Form + Strength Wilpium-Plus 18mcg+12mcg Rotacaps
Tiotropium (as bromide monohydrate) …18mcg
Formoterol fumarate …12mcg
Pharmacological Group Other Drugs for Obstructive Airway Diseases, Inhalants
(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 (Not
Regulatory Authorities. Reference Regulatory Authority)
Me-too Status Tiovair-F Rotacaps 18mcg+12mcg by M/s Highnoon
Brand Name + Dosage Form + Strength Wilterol 150mcg Rotacaps
Indacaterol (as maleate) …150mcg
Pharmacological Group Selective beta-2-adrenoreceptor agonists
rd
133
Type of Form Form-5
Approval Status of Product in Reference ONBREZ BREEZHALER indacaterol maleate 150
Regulatory Authorities. microgram hard capsule for inhalation by M/s Novartis
Pharmaceuticals Australia Pty Ltd (TGA Approved)
Me-too Status ONBREZ BREEZHALER 150MCG Capsule for
INHALATION by M/s NOVARTIS (Reg#069586)

Brand Name + Dosage Form + Strength Wilterol-DS 300mcg Rotacaps
Indacaterol (as maleate) …300mcg
Type of Form Form-5
Approval Status of Product in Reference ONBREZ BREEZHALER indacaterol maleate 300
Regulatory Authorities. microgram hard capsule for inhalation by M/s Novartis
Pharmaceuticals Australia Pty Ltd (TGA Approved)
Me-too Status Onbrez Breezhaler 300mcg Capsule for Inhalation by M/s
Novartis (Reg#069587)

Brand Name + Dosage Form + Strength Wiltide Plus 50mcg+100mcg Rotacaps
Fluticasone propionate …100mcg
Salmeterol (as xinafoate) …50mcg
Pharmacological Group Adrenergics, Inhalants (Adrenergics in combination with
corticosteroids or other drugs, excl. anticholinergics)
Type of Form Form-5
Pack Size & Demanded Price 28’s, 60’s/ As per SRO
Approval Status of Product in Reference Seretide Accuhaler 50 microgram /100 microgram /dose
Regulatory Authorities. inhalation powder, predispensed. by M/s Glaxo Wellcome
UK Ltd (MHRA Approved)
Me-too Status Not confirmed.
Remarks of the Evaluator.  Evidence of rotacaps is not found in Reference
Regulatory Authorities. This formulation is available as,
metered dose dry powder inhaler.
 Evidence of rotacaps is not found in available me-too
database.
Type of Form Form-5
database.
Type of Form Form-5
database.
Brand Name + Dosage Form + Strength Wilsonide Plus 100mcg+6mcg Rotacaps
Budesonide …100mcg
Type of Form Form-5
Approval Status of Product in Reference Symbicort 100/6 Turbohaler, Inhalation Powder by M/s
Me-too Status Combivair 100mcg+6mcgRotacaps by M/s Highnoon
Regulatory Authorities. This formulation is available as
Symbicort available in a multidose inspiratory flow
driven, metered dose dry powder inhaler (Turbuhaler).
product.
Type of Form Form-5
Approval Status of Product in Reference Symbicort 200/6 Turbohaler, Inhalation Powder by M/s
Regulatory Authorities. This formulation is available as
Symbicort available in a multidose inspiratory flow
driven, metered dose dry powder inhaler (Turbuhaler).
product.
Type of Form Form-5
333. Name and Address of Manufacturer / M/s. Bio-Labs (Pvt.) Ltd.,
Applicant Plot No. 145 Industrial Triangle, Kahuta Road, Islamabad.
Brand Name + Dosage Form + Strength Biosev 400mg Tablet
Sevelamer hydrochloride …400mg
Pharmacological Group Drugs for treatment of hyperkalemia and
hyperphosphatemia
Type of Form Form-5
Pack Size & Demanded Price 3x10’s/ As per SRO
Approval Status of Product in Reference Renagel 400mg Tablet by M/s Genzyme Corporation,
Me-too Status Renavel 400mg Tablet by M/s Genome Pharmaceuticals
(Reg#73228)
GMP Status Last GMP inspection conducted on 05-12-2017 and 06-12-
2017 concluding grant of cGMP certificate.
Brand Name + Dosage Form + Strength Biocib 60mg Tablet
Etoricoxib …60mg
(Coxibs)
Type of Form Form-5
Approval Status of Product in Reference ARCOXIA 60 mg Film-coated Tablets by M/s Merck Sharp
Regulatory Authorities. & Dohme BV (MHRA Approved)
Me-too Status Arcoxia 60mg Tablets by M/s MERCK & CO INC
(Reg#47529)
Brand Name + Dosage Form + Strength Biobec 10mg Tablet
Baclofen …10mg
Pharmacological Group Muscle Relaxants, Centrally Acting Agents (Other centrally
acting agents)
Type of Form Form-5
Pack Size & Demanded Price 3x10’s/ As per SRO
Approval Status of Product in Reference Baclofen 10 mg Tablets by M/s TEVA UK Limited (MHRA
Me-too Status LIORESAL 10MG TAB by M/s CIBA (Reg#007822)
GMP Status Last GMP inspection conducted on 05 and 06th December,
Decision: Approved.
Brand Name + Dosage Form + Strength Biofinil 100mg Tablet
Modafinil …100mg
Pharmacological Group Psychostimulants, agents used for adhd and nootropics
(Centrally acting sympathomimetics)
Type of Form Form-5
Approval Status of Product in Reference Modafinil 100 mg Tablets by M/s Generics [UK] Limited
Regulatory Authorities. trading as Mylan (MHRA Approved)
Me-too Status Monalert 100mg Tablet by M/s Hilton (Reg#047170)
Brand Name + Dosage Form + Strength Biofinil 200mg Tablet
Composition Each tablet contains: Modafinil …200mg
Pharmacological Group Psychostimulants, agents used for adhd and nootropics
(Centrally acting sympathomimetics)
Type of Form Form-5
Approval Status of Product in Reference Modafinil 200 mg Tablets by M/s Generics [UK] Limited
Regulatory Authorities. trading as Mylan (MHRA Approved)
Me-too Status Monalert 200mg Tablet by M/s Hilton (Reg#047171)
Brand Name + Dosage Form + Strength Betalab 8mg Tablet
Betahistine dihydrochloride …8mg
Pharmacological Group Antivertigo preparations
Type of Form Form-5
Approval Status of Product in Reference Betahistine 8 mg tablets by M/s Milpharm Limited (MHRA
Me-too Status Vetinil 8mg Tablet by M/s Standpharm Pakistan (Pvt) Ltd
(Reg#040956)
Decision: Approved.
Type of Form Form-5
Pack Size & Demanded Price 10’s, 20’s, 30’s, 60’s, 84’s, 90’s/ As per SRO
Me-too Status Vetinil 16mg Tablet by M/s Standpharm Pakistan (Pvt) Ltd
(Reg#040957)
Decision: Approved.
Type of Form Form-5
Me-too Status Statobex 24mg Tablet by M/s Stan Atco Laboratories
(Reg#058432)
Decision: Approved.
Brand Name + Dosage Form + Strength Clearin 10mg Capsules
Isotretinoin …10mg
Pharmacological Group Anti-acne preparation
Type of Form Form-5
Approval Status of Product in Reference Absorica capsules of M/s Sun Pharm INDS INC (USFDA
Me-too Status No-Acne 10mg Capsules of M/s Platinum, (Reg#044013)
Remarks of the Evaluator.  Firm has not submitted formulation as approved in RRA.
 Firm has not submitted stability study data for product as
per zone IV-A
Decision: Registration board deferred the case for review of formulation as decided in 250th meeting
Brand Name + Dosage Form + Strength Clearin 20mg Capsules
Isotretinoin …20mg
Pharmacological Group Anti-acne preparation
Type of Form Form-5
Approval Status of Product in Reference Absorica capsules of M/s Sun Pharm INDS INC (USFDA
Me-too Status No-Acne 20mg Capsules of M/s Platinum, (Reg#044014)
Remarks of the Evaluator.  Firm has not submitted formulation as approved in RRA.
 Firm has not submitted stability study data for product as
per zone IV-A
Decision: Registration board deferred the case for review of formulation as decided in 250th meeting
Brand Name + Dosage Form + Strength Zoldrone 4mg/100ml Vial
Composition Each 100ml infusion contains:
Zoledronic acid (as monohydrate)…4mg
Pharmacological Group Drugs affecting bone structure and mineralization
(Bisphosphonates)
Type of Form Form-5
Pack Size & Demanded Price 100ml x 1’s / As per SRO
Approval Status of Product in Reference Zerlinda 4mg/100ml solution for infusion by M/s Actavis
Regulatory Authorities. Group PTC ehf. (MHRA Approved)
Me-too Status Zoleron 4mg/100ml Infusion by M/s Genix (Reg#081456)
Firm has Infusion 100ml (General) section.
Brand Name + Dosage Form + Strength Zoldrone 5mg/100ml Vial
Zoledronic acid (as monohydrate)…5mg
Pharmacological Group Drugs affecting bone structure and mineralization
(Bisphosphonates)
Type of Form Form-5
Pack Size & Demanded Price 100ml x 1’s / As per SRO
Approval Status of Product in Reference Zoledronic acid Zentiva 5 mg / 100 ml solution for infusion
Regulatory Authorities. by M/s Winthrop Pharmaceuticals UK Limited (MHRA
Approved)
Me-too Status Zoldric by Searle
Firm has Infusion 100ml (General) section.
345. Name and Address of Manufacturer / M/s Bio-Mark Pharmaceuticals.
Applicant Plot No. 527, Sunder Indusrial Estate, Lahore.
Brand Name + Dosage Form + Strength Ecoxib 60mg Tablets
Composition Each film coated tablet contains;
Etoricoxib…60mg
Pharmacological Group Antiinflammatory and Antirheumatic Products, Non Steroids
(Coxibs)
Type of Form Form-5
Finished Product Specification Innovator’s Specifications
Approval Status of Product in Reference ARCOXIA 60 mg film-coated tablet by M/s Grunenthal Ltd,
Regulatory Authorities. (MHRA approved)
Me-too Status Arcox 60 mg tablet by M/s MAQ Pharmaceuticals
(Reg No: 076808)
GMP Status 10-03-2017, Grant of DML
Remarks of the Evaluator.  Inspection report older than 1 year
 Firm has submitted reply that:
‘We submitted dossiers in June & July 2017.
We received Registrations in Oct, Nov, 2017 & Feb 2018.
We started production in Feb 2018.’
Firm on priority.
Brand Name + Dosage Form + Strength Trimet MR 35mg Tablets
Composition Each modified release film-coated tablet contains:
Trimetazidine dihydrochloride …35mg
Pharmacological Group Other cardiac preparations
Type of Form Form-5
Approval Status of Product in Reference Vastarel 35 mg - modified-release film-coated tablets by M/s
Regulatory Authorities. SERVIER AUSTRIA GmbH (AGES Austria Approved)
Me-too Status Trikat MR Tablets 35mg by M/s Novamed Pharmaceuticals
(Reg#64849)
Grant of DML
Firm on priority.
Brand Name + Dosage Form + Strength Azith 250mg Tablets
Azithromycin (as dihydrate) …250mg
Type of Form Form-5
Approval Status of Product in Reference Azithromycin 250 mg film-coated tablets by M/s Milpharm
Regulatory Authorities. Limited (MHRA Approved)
Me-too Status Plazo Tablets 250mg by M/s Platinum Pharmaceuticals (Pvt)
Ltd (Reg#025507)
Grant of DML
Remarks of the Evaluator.  Inspection report older than 1 year.
Firm on priority.
Brand Name + Dosage Form + Strength Azith 500mg Tablets
Azithromycin (as dihydrate) …250mg
Type of Form Form-5
Approval Status of Product in Reference Azithromycin Tablets 500mg by M/s Aurobindo Pharma
Me-too Status Zetro 500mg Tablets by M/s Getz Pharma (Pvt.) Ltd
(Reg#053120)
Grant of DML
Firm on priority.
Brand Name + Dosage Form + Strength Eslor 5mg Tablets
Desloratadine …5mg
Pharmacological Group Other antihistamines for systemic use
Type of Form Form-5
Approval Status of Product in Reference Desloratadine 5 mg Film-Coated Tablets by M/s Crescent
Regulatory Authorities. Pharma Ltd (MHRA Approved)
Me-too Status Mdisin 5mg Tablet by M/s Metro Pharmaceuticals (Reg#
081672)
Grant of DML
Firm on priority.
Brand Name + Dosage Form + Strength Febuxo 40mg Tablets
Febuxostat …40mg
Pharmacological Group Preparations inhibiting uric acid production
Type of Form Form-5
Approval Status of Product in Reference ULORIC 40mg tablet by M/s Takeda Pharma (USFDA
Me-too Status Febuxin 40mg Tablet by M/s AGP Pvt. Ltd. (Reg# 081104)
Grant of DML
Firm on priority.
Brand Name + Dosage Form + Strength Febuxo 80mg Tablets
Febuxostat …80mg
Pharmacological Group Preparations inhibiting uric acid production
Type of Form Form-5
Approval Status of Product in Reference Febuxostat 80 mg Film-coated Tablets by M/s TEVA UK
Me-too Status Febuxin 80mg Tablet by M/s AGP Pvt. Ltd. (Reg# 081105)
Grant of DML
Firm on priority.
Brand Name + Dosage Form + Strength Fyline 400mg Tablets
Composition Each uncoated tablet contains:
Doxofylline …400mg
Pharmacological Group Other Systemic Drugs for Obstructive Airway Diseases
(Xanthines)
Type of Form Form-5
Finished Product Specification Innovator’s specifications.
Approval Status of Product in Reference DOXOFILLINA ABC 400 mg tablet by M/s ABC
Regulatory Authorities. FARMACEUTICI S.p.A (Italian Medicine Agency approved)
Me-too Status Profylline Tablet 400mg by M/s Kaizen (Reg# 073744)
GMP Status 10-03-2017; Grant of DML
Firm on priority.
Brand Name + Dosage Form + Strength Mivab 7.5mg Tablets
Ivabradine (as hydrochloride) …7.5mg
Pharmacological Group Other cardiac preparations
Type of Form Form-5
Approval Status of Product in Reference PROCORALAN 7.5 mg film-coated tablets by M/s SERVIER
Regulatory Authorities. LABORATORIES (ANSM approved)
Me-too Status Ivatab 7.5mg Tablet by M/s Nabiqasim (Reg# 076155)
Firm on priority.
Brand Name + Dosage Form + Strength Miflox 400mg Tablets
Composition Each film coated tablet contains;
Moxifloxacin (as hydrochloride) ...400mg
Pharmacological Group Fluoroquinolones
Type of Form Form-5
Pack Size & Demanded Price 5’s / As per SRO
Approval Status of Product in Reference Avelox 400 mg film-coated tablets by M/s Bayer plc,(MHRA
Me-too Status Metoxim 400mg Tablet by M/s Foray Pharmaceutica (Reg
No:056083)
GMP Status 10-03-2017, Grant of DML
Firm on priority.
Brand Name + Dosage Form + Strength Dextine 30mg Capsules
Diary No. Date of R & I & fee Diary No:6118,14/06/2017, Rs: 20,000/-
Enteric coated Pellets (17%) of Duloxetine hydrochloride
Pharmacological Group Other antidepressants
Type of Form Form-5
Me-too Status Dulan (Duloxetine 30mg capsule) by M/s Hilton
Pharma.(Reg#055447)
Remarks of the Evaluator.  Source of pellets: Vision Pharmaceuticals, Islamabad.
 Inspection report older than 1 year
Firm on priority.
Brand Name + Dosage Form + Strength Dextine 60mg Capsules
Enteric coated Pellets (17%) of Duloxetine hydrochloride
Type of Form Form-5
Pharma.(Reg#055448)
Remarks of the Evaluator.  Source of pellets: Vision Pharmaceuticals, Islamabad.
Firm on priority.
Brand Name + Dosage Form + Strength Pediz Sachet
Sodium chloride…2.6g
Tri sodium citrate dihydrate …2.9g
Potassium chloride…1.5g
Glucose anhydrous…13.5g
Pharmacological Group Oral Rehydration Salts
Type of Form Form-5
Finished Product Specification International Pharmacopeia Specifications
Approval Status of Product in Reference Reduced Osmolarity Oral Rehydration Slat (WHO Approved)
Me-too Status Orsol Sachet by M/s Kaizan (Reg#073897)
GMP Status Last inspection report dated 10-03-2017 for the Grant of DML.
Firm on priority.
Brand Name + Dosage Form + Strength Neo-Choline Oral Drops
Citicoline (as sodium) …100mg
Pharmacological Group Other psychostimulants and nootropics
Type of Form Form-5
Pack Size & Demanded Price 30ml/ As per SRO
Me-too Status Somazina Drops By M/s Alina (Reg#016974)
Remarks of the Evaluator.  Packaging in dropper container closure system not
confirmed from RRA, but the applied formulation is
approved by Spanish Health Agency.
Firm on priority.
Brand Name + Dosage Form + Strength Neo-Choline Oral Solution 100 mg/ml
Citicoline (as sodium) …100mg
Pharmacological Group Other psychostimulants and nootropics
Type of Form Form-5
Pack Size & Demanded Price 30ml, 60ml/ As per SRO
Approval Status of Product in Reference Citicolina Ferrer 100mg/ml Solucion Oral EFG by M/s Ferrer
Regulatory Authorities. Internacional,S.A (Spain Approved)
Me-too Status Citolin Syrup by M/s Global Pharmaceuticals (Reg#029540)
Firm on priority.
Brand Name + Dosage Form + Strength Fyline Oral Syrup 100mg/5ml
Doxofylline …100mg
Pharmacological Group Other Systemic Drugs for Obstructive Airway Diseases
(Xanthines)
Type of Form Form-5
Approval Status of Product in Reference DOXOFILLINA ABC 200 mg / 10 ml Syrup by M/s ABC
Regulatory Authorities. FARMACEUTICI SpA - Corso Vittorio (Italian Medicine
Agency (AIFA) Italy Approved)
Me-too Status Unifyline Syrup 100mg/5ml by M/s Platinum Pharmaceuticals
(Reg# 047180)
Remarks of the Evaluator.  Inspection report older than 1year Firm has submitted
reply that:
Firm on priority.
Brand Name + Dosage Form + Strength Bamtil Oral Syrup 5mg/5ml
Bambuterol hydrochloride …5mg
Type of Form Form-5
Approval Status of Product in Reference Bambuterol juice 1mg/ml by AstraZaneca
Regulatory Authorities. (Germany Approved)
Me-too Status Btno 5mg/5ml syrup by M/s Genix (Reg# 057873)
We started production in Feb 2018.
Firm on priority.
Evaluator PEC-III
362. Name and address of manufacturer / M/s Saffron Pharmaceuticals (Pvt) Ltd., 19Km, Sheikhupura
Applicant Road, Faisalabad.
Brand Name +Dosage Form + Strength Hi-Gab Capsule 150mg
Diary No. Date of R& I & fee DUPLICATE DOSSIER
PKR 8,000/-: 4-3-2011 + PKR 12,000/-: 2-4-2015
Pregabalin……..150mg
Pharmacological Group Antconvulsant
Type of Form Form 5
Finished Product Specification Firm has claimed in house specification
Pack size & Demanded Price 14’s: Rs. 2000/-
Approval status of product in Reference Lyrica capsules of M/s Pfizer limited
Me-too status Gabica capsules of M/s Getz Pharma
GMP status Last inspection report 13-10-2017: Panel recommends renewal
of DML
Remarks of the Evaluator. 
Decision: Approved with innovator’s specification. 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 Inso 1mg Tablet
PKR 8,000/-: 13-8-2010 +PKR 12,000/-: 2-4-2015
Eszopiclone……1mg
Pharmacological Group Benzodiazepine related drugs
Type of Form Form 5
Pack size & Demanded Price 10’s: Rs 150/-
Approval status of product in Reference Lunesta Tablet by Sunovion Pharms
Me-too status Clonexa Tablet by Atco
of DML
Remarks of the Evaluator.  Firm has initially applied for uncoated tablet, later in response
to letter of shortcoming, firm has requested to revise their
formulation to film coated tablet, firm has also submitted fee
PKR 5,000/- (Chalan No. 0054605) for revision of formulation.
PKR 8,000/-: 13-8-2010 +PKR 12,000/-: 2-4-2015
Type of Form Form 5
of DML
PKR 8,000/-: 13-8-2010 +PKR 12,000/-: 2-4-2015
Type of Form Form 5
of DML
366. Name and address of manufacturer / Jenner Pharmaceuticals (Pvt.) Ltd. 26-Km Lahore Sharaqpur
Applicant Road Sheikhupura
Brand Name +Dosage Form + Strength Dulux 60mg Capsule
Diary No. Date of R& I & fee Dy No. 1209: 20-10-2015 PKR 20,000/- + 80,000/-: 14-10-2015
Composition Each capsule contains
Enteric coated pellets of Duloxetine hydrochloride equivalent to
Duloxetine………60mg
Pharmacological Group Anti-depressant
Type of Form Form-5
Approval status of product in Reference Cymbalta Capsules by Lilly
Me-too status Dulan 60mg Capsules by Hilton
GMP status GMP inspection dated 06-11-2017 concluded that Overall the
condition of the firm is satisfactory regarding to building,
equipment, and functioning of HVAC system. However, they
were advised to improve their documentation regarding the
production and quality, they agreed.
Remarks of the Evaluator. Firm has submitted following:
 Source: M/s Spansules Formulations, India
 Certificate of analysis of Duloxetine pellets as per USP
specification.
 Decision: Approved.
367. Name and address of manufacturer / M/s Pakistan Pharmaceutical Products (Pvt) Ltd., D-122, Sindh
Brand Name +Dosage Form + Strength Parley Tablet 20mg
Diary No. Date of R& I & fee Dy No. 373: 29-12-2014 PKR 20,000/-: 26-12-2014
Paroxetine (as hydrochloride)………20mg
Pharmacological Group Serotonin uptake inhibitor
Type of Form Form 5
Pack size & Demanded Price 1 x 10’s: As per SRO
Approval status of product in Reference Paxil Tablet by Apotex Technologies
Me-too status Praxyl tablet by CCL
GMP status Last GMP inspection report dated 12-12-2017 concludes that
firm has improved according to directions of FID. Panel was
satisfied for improvements undertaken by the firm to comply
with observations dated 1st and 2nd August 2017. Panel advised
the firm to continue the improvement process.
 Decision: Approved.
Brand Name +Dosage Form + Strength Dynata Capsule 60mg
Duloxetine (as hydrochloride) enteric coated pellets……60mg
Type of Form Form 5
Approval status of product in Reference Cymbalta Capsules by Lilly
Me-too status Dulan 60mg Capsules by Hilton
Remarks of the Evaluator. Source of pellets: M/s Vision Pharmaceuticals, Islamabad.
Decision: Approved.
Brand Name +Dosage Form + Strength Cibra Capsule 40mg
Omeprazole (enteric coated pellets)………40mg
Pharmacological Group Serotonin uptake inhibitor
Type of Form Form 5
Pack size & Demanded Price 2 x 7s: As per SRO
Approval status of product in Reference Omeprazole by Actavis
Me-too status Xempra 40mg Capsule by Genome Pharmaceutical
Remarks of the Evaluator. Source of pellets: M/s Vision Pharmaceuticals, Islamabad.
Decision: Approved.
Brand Name +Dosage Form + Strength Panoram Injection 500mg
Meropenem as trihydrate………500mg
Pharmacological Group Carbapenem
Type of Form Form 5
Pack size & Demanded Price 1’s: As per SRO
Approval status of product in Reference Merem Injection by Pfizer
Me-too status Mopen 500mg Injection by Hilton Pharma
Remarks of the Evaluator.  Firm do not have injection carbapenem section. CLB in its 240th
meeting have renewed the DML of the firm for 16 sections
(including warehouse and QC Lab) which do not contain
carbapenem section.
Decision: Registration Board rejected the application since the firm do not have approved
manufacturing facility for carbapenem injection.
371. Name and address of manufacturer / M/s Jawa Pharmaceuticals, 112/10, Industrial Estate, Kot
Applicant Lakhpat, Lahore.
Brand Name +Dosage Form + Strength Gnate Injection
Diary No. Date of R& I & fee (DUPLICATE DOSSIER): 19-10-2015
New submission: Dy No. 14753: 20-4-2018
PKR 20,000/-: 19-10-2015 (DUPLICATE)
Dimenhydrinate…..50mg
Type of Form Form 5
Pack size & Demanded Price 1ml glass ampoule: 25 ampoule per carton: As per SRO
Approval status of product in Reference Dimenhydrinate Injection by Fresenius Kabi
Me-too status Diomine injection by Venus Pharma
GMP status Last inspection report dated 18-7-2017 confirms satisfactory
compliance to GMP.
Remarks of the Evaluator.  Fee chalan needs verification from Budget and Accounts
Division
 Decision: Approved. Reference will be sent to Budget & Accounts Division for verification of challan
Brand Name +Dosage Form + Strength Astamol Injection
PKR 20,000/-: 19-10-2015
Salbutamol sulphate eq to salbutamol…..0.5mg
Pharmacological Group Bronchodilator
Type of Form Form 5
Pack size & Demanded Price 1ml glass ampoule: 5’s: As per SRO
Approval status of product in Reference Ventolin injection by Glaxo Wellcome
Me-too status Ventolin Injection by GSK
compliance to GMP.
Division
Brand Name +Dosage Form + Strength Fopera Injection
PKR 20,000/-: 19-10-2015
Cefoperazone (as sodium)……500mg
Sulbactam (as sodium)……….500mg
Type of Form Form 5
Finished Product Specification JP Specs
Approval status of product in Reference Sulperazon Injection by Pfizer Inc.
Regulatory Authorities. (PMDA Approved)
Me-too status Bezone Injection by Medisave
compliance to GMP.
Division
Brand Name +Dosage Form + Strength Fopera Injection
PKR 20,000/-: 19-10-2015
Cefoperazone (as sodium)……1g
Sulbactam (as sodium)……….1g
Type of Form Form 5
Approval status of product in Reference Approved by 3 European countries
Me-too status Bezone Injection by Medisave
compliance to GMP.
Division
Brand Name +Dosage Form + Strength T-ZD Injection 250mg
PKR 20,000/-: 19-10-2015
Ceftazidime (as pentahydrate)….250mg
Type of Form Form 5
Approval status of product in Reference Fortum Injection by Glaxo Operations UK
Me-too status Fortum injection by GSK
compliance to GMP.
Division
Brand Name +Dosage Form + Strength T-ZD Injection 500mg
PKR 20,000/-: 19-10-2015
Ceftazidime (as pentahydrate)….500mg
Type of Form Form 5
compliance to GMP.
Division
Brand Name +Dosage Form + Strength T-ZD Injection 1g
PKR 20,000/-: 19-10-2015
Ceftazidime (as pentahydrate)….1g
Type of Form Form 5
compliance to GMP.
Division
Brand Name +Dosage Form + Strength Safpirom Injection 500mg
PKR 20,000/-: 19-10-2015
Cefpirome (as sulfate)…….500mg
Type of Form Form 5
Approval status of product in Reference Approved in ANSM
Me-too status Pirome Injection 500mg of Cirin Pharmaceuticals
compliance to GMP.
Division
 Decision: Approved with innovator’s specification. Reference will be sent to Budget & Accounts
Brand Name +Dosage Form + Strength Safpirom Injection 1g
PKR 20,000/-: 19-10-2015
Cefpirome (as sulfate)…….1g
Type of Form Form 5
Approval status of product in Reference Approved in ANSM
Me-too status Pirome Injection 1g of Cirin Pharmaceuticals
compliance to GMP.
Division
 Decision: Approved with innovator’s specification. Reference will be sent to Budget & Accounts
Brand Name +Dosage Form + Strength Zolin Injection 500mg
PKR 20,000/-: 19-10-2015
Cefazolin (as sodium)…….500mg
Type of Form Form 5
Approval status of product in Reference Cefazolin For Injection 500mg by M/s Sandoz
Me-too status Safelin Injection 500mg by M/s Fassgen Pharmaceuticals
compliance to GMP.
Division
Brand Name +Dosage Form + Strength Zolin Injection 1g
PKR 20,000/-: 19-10-2015
Cefazolin (as sodium)…….1g
Type of Form Form 5
Approval status of product in Reference Cefazolin for Injection 1g by M/s Sandoz
Me-too status Safelin Injection 1g by M/s Fassgen Pharmaceuticals
compliance to GMP.
Division
Brand Name +Dosage Form + Strength Furoxime Injection 250mg
PKR 20,000/-: 19-10-2015
Cefuroxime (as sodium)…….250mg
Type of Form Form 5
Approval status of product in Reference Cefuroxime powder for solution for injection by M/s Stragen
Me-too status Zinacef 250mg Injection by M/s GSK
compliance to GMP.
Division
Brand Name +Dosage Form + Strength Furoxime Injection 750mg
PKR 20,000/-: 19-10-2015
Cefuroxime (as sodium)…….750mg
Type of Form Form 5
Me-too status Zinacef 750mg Injection by M/s GSK
compliance to GMP.
Division

Brand Name +Dosage Form + Strength Furoxime Injection 1.5g
PKR 20,000/-: 19-10-2015
Cefuroxime (as sodium)…….1.5g
Type of Form Form 5
Me-too status Zecef Injection 1.5gm by Bosch Pharma
compliance to GMP.
Division
385. Name and address of manufacturer / M/s Reliance Pharma Plot No. 8, street No. S-8, National
Applicant Industrial Zones, Rawat-Islamabad.
Brand Name +Dosage Form + Strength Vominil 50mg Tablet
Diary No. Date of R& I & fee Dy No. 8596:13-7-2017
PKR 20,000/-: 13-7-2017
Itopride hydrochloride……….50mg
Type of Form Form 5
Pack size & Demanded Price 1x10’s: As per SRO
Approval status of product in Reference PMDA approved
Me-too status Ganaton 50mg tablet of Abbott
GMP status Last inspection report dated 27-4-2018: Panel recommends
renewal of DML
 Decision: Approved with innovator’s specification and change of brand name
Number of approved sections Already approved products in Currently applied
of applicant firm contract manufacturing products
4 2 3
386. Name and address of manufacturer / Ms Reliance Pharma, Plot No. 8, Street No. S-8 RCCI Industrial
Applicant Estate, Rawat.
Contract manufactured by: Ms EG Pharmaceuticals, Plot No.
13-A, Industrial Triangle Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength E-Rel Injection 250mg IV
Ceftriaxone sodium eq to ceftriaxone…….250mg
Type of Form Form 5
Approval status of product in Reference Rocephin Injection by Roche
Me-too status Rocephin Injection by Roche
GMP status Last GMP inspection of EG Pharma conducted on 22-6-2017,
report concludes that overall firm is operating at reasonable level
of compliance with GMP.
 Decision: Registration Board deferred the case for assessment and confirmation of manufacturing
constituted by Chairman Registration Board for further granting contract manufacturing
permission as the firm has already been granted approval for contract manufacturing of numerous
products. Moreover Registration board referred the case to QA & LT Division to conduct GMP
inpection of the M/s EG Pharmaceuticals, Industrial Triangle Kahuta road, Islamabad on priority
basis.
Brand Name +Dosage Form + Strength E-Rel Injection 500mg IV
Ceftriaxone sodium eq to ceftriaxone…….500mg
Type of Form Form 5
basis.
Brand Name +Dosage Form + Strength E-Rel Injection 1g IV
Ceftriaxone sodium eq to ceftriaxone…….1g
Type of Form Form 5
rd
159
basis.
389. Name and address of manufacturer / M/s Lisko Pakistan (Pvt) Ltd., L-10-D, Block-21, Shaheed
Applicant Rashid Minhas Road F.B Industrial Area Karachi.
Brand Name +Dosage Form + Strength Valsart Plus Tablet 10/160/25mg
Amlodipine as besylate………10mg
Valsartan……160mg
Hydrochlorthiazide………25mg
Type of Form Form 5
Pack size & Demanded Price 14’s, 28’s:
Approval status of product in Reference Exforge HCT tablet by Novartis
Me-too status Exforge HCT tablet by Novartis
compliance to GMP.
 Decision: Registration Board deferred the case as FID has reported for not having stability chamber

Brand Name +Dosage Form + Strength Mypride 50mg Tablet
Itopride hydrochloride….......50mg
Type of Form Form 5
Finished Product Specification Firm has claimed in house specifications
Approval status of product in Reference (PMDA approved)
Me-too status Ganaton 50 mg tablet by M/s Abbott.
compliance to GMP.
 Decision: Registration Board deferred the case as FID has reported for not having stability chamber
Brand Name +Dosage Form + Strength Kufest Syrup
Carbocisteine………250mg
Pharmacological Group Mucolytic
Type of Form Form 5
Finished Product Specification Firm has claimed in house specifications
Pack size & Demanded Price 120ml Bottle: As per SRO
Approval status of product in Reference Mucodyne Oral solution of M/s Sanofi Aventis
Me-too status Rhinathiol 5% for adults of M/s Sanofi Aventis
compliance to GMP.
Evaluator PEC-VII
392. Name and address of manufacturer / Rasco Pharma, 5.5 Km Raiwind Road Lahore
Applicant
Brand Name +Dosage Form + Strength Clonazee tablets 0.5 mg
Clonazepam ………………0.5 mg
Diary No. Date of R& I & fee Dy.No. 11720, 10-8-2017, Rs.20,000/=
Pharmacological Group Benzodiazepine derivative
Type of Form Form-5
Pack size & Demanded Price 5x10’s
As Per SRO
Approval status of product in Reference Clonazepam Auden 500mcg Tablets by M/s Auden Mckenzie
Regulatory Authorities. (Pharma Division) Ltd (MHRA Approved)
Me-too status Tovir 0.5mg Tablet by M/s Adamjee (Reg#080335)
is provided.
Remarks of Evaluator  Evidence of Section approval of tablet (Psychotropic) is
avilable
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Paroxitil-CR tablet 25 mg
Composition Each Film, enteric coated controlled release tablet contains:
Paroxetine (as hydrochloride) …... 25mg
Pharmacological Group Selective serotonin reuptake inhibitors
Type of Form Form-5
Pack size & Demanded Price 3x10’s / As Per SRO
Approval status of product in Reference Paxil CR Tablet 25mg of M/s Apotex Technologies (USFDA)
Me-too status Seroxat CR 25mg of M/s GSK Pharmaceuticals)
is provided.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Lacomide tablet 150 mg
Lacosamide………150mg
Pharmacological Group Antiepileptic
Type of Form Form-5
Finished Product Specification Manufacturer
As Per SRO
Approval status of product in Reference Vimpat tablet of (USFDA approved)
Me-too status Atcomid 150mg Tablet M/s Atco Lab
is provided.
Remarks of Evaluator  No BP and USP monograph is found.
Applicant
Brand Name +Dosage Form + Strength Mementa tablet 10 mg
Mementine as HCl………10 mg
Pharmacological Group NMDA receptor antagonists
Type of Form Form-5
As Per SRO
Approval status of product in Reference Ebixa tablets by Lundbeck
Me-too status Memanda 10mg Tablets by M/s Fassgen
is provided.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Lacomide 100 mg tablet
Lacosamide……….100mg
Type of Form Form-5
As Per SRO
Approval status of product in Reference Vimpat oral tablet of UCB Inc, USFDA
Me-too status Lacolep tablet of Hilton Pharma (Reg # 073858)
is provided.
Remarks of Evaluator No monograph was found in USP or BP
Applicant
Brand Name +Dosage Form + Strength Fixa tablet 550 mg
Rifaximin……550mg
Type of Form Form-5
As Per SRO
Approval status of product in Reference Targaxan tablets by Norgine
Me-too status Registration Number: Nixaf 550mg Tablet of Sami, Karachi
(073700)
is provided.
Applicant
Brand Name +Dosage Form + Strength Tranxo injection 500 mg/ 5ml
Type of Form Form-5
Pack size & Demanded Price 5 ml x10’s
As Per SRO
Approval status of product in Reference Cyklokapron 500mg Solution for Injection by M/s Pfizer Limited
Regulatory Authorities. (MHRA approved )
Me-too status Traxacid Injection 500mg/5ml by M/s Asian Continental
(Reg#057866)
is provided.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Clonazee tablet 2 mg
Composition Each Tablet contains:
Clonazepam…2 mg
Pharmacological Group Benzodiazepine derivatives
Type of Form Form-5
As Per SRO
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)
is provided.
Remarks of Evaluator Tablet psychotropic section is present
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Acetadol (37.5 mg/ 325 mg)
Tramadol (as HCl) ………….. 37.5mg
Paracetamol …… 325mg
Pharmacological Group Opiate analogue/analgesic
Type of Form Form-5
As Per SRO
is provided.
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Co-Vilda tablet 50 mg/1000 mg)
Composition Each film coated tablet contains: Vildagliptin………50mg
Metformin as HCl………1000mg
Pharmacological Group Dipeptidyl peptidase-4 inhibitor/Biguanide
Type of Form Form-5
As Per SRO
Approval status of product in Reference GA Galvumet Tablet Of (TGA Approved)
Me-too status Me-too status Vilget-M 50mg+1000mg Tablet M/s Getz
is provided.
Remarks of Evaluator Firm has claimed Mfg Specifications and the product is not
present in available pharmacopoeia
shelf life of 18 months with packaging material of PA/Al/PVC/Al
-polyamide-aluminum foil-polyvinylchloride/ aluminum foil or
PCTFE/PVC/Alu or 2 years with PA/Alu/ PVC/Alu.
Applicant
Brand Name +Dosage Form + Strength Paroxitil-CR Tablet 12.5 mg
Composition Each enteric control release tablet contains:
Paroxetine as HCl ………………..12.5 mg
Type of Form Form-5
As Per SRO
Approval status of product in Reference Paxil CR Tablet of M/s Apotex Technologies (USFDA)
Me-too status Paroxin CR 12.5mg Tablet by M/s Sharooq Pharmaceuticals
is provided.
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Lacomide tablet 50 mg
Lacosamide………50mg
Type of Form Form-5
As Per SRO
Approval status of product in Reference Vimpat tablet of (USFDA approved)
Me-too status Atcomid 50mg Tablet M/s Atco Lab
is provided.
Remarks of Evaluator  No BP and USP monograph is found.
404. Name and address of manufacturer / M/s. Jawa Pharmaceuticals (Pvt) Ltd, 112/10, Quaid-i-Azam
Applicant industrial area, Kotlakhpat Lahore
Brand Name +Dosage Form + Strength Jevelexin 500 mg infusion
Levofloxacin as hemihydrate…...500mg
Pharmacological Group Quinolone antibiotic
Type of Form Form-5
Approval status of product in Reference Evoxil 5mg/ml solution for infusion (MHRA approved )
Me-too status Levort DS Infusion 500mg/100ml of M/s Orta Laboratories
GMP status Last GMP Inspection conducted on 18.07.2017 with conclusive
remarks of satisfactory level of cGMP.
Remarks of Evaluator Firm has claimed Mfg Specifications and the product is not
present in available pharmacopoeia
Brand Name +Dosage Form + Strength Jawaflox 400 mg infusion IV
Composition Each 100 ml vial contains:
Levofloxacin as hemihydrate…...400 mg
Type of Form Form-5
Approval status of product in Reference NA
Me-too status NA
Remarks of Evaluator Evidence of formulation in reference regulatory authority
Evidence of formulation in DRAP
•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
Brand Name +Dosage Form + Strength Mox-Q 400 mg infusion
Composition Each vial of 250ml solution contains:
Moxifloxacin HCl eq to Moxifloxacin…..400mg
Type of Form Form-5
Finished Product Specification Innovators
Pack size & Demanded Price 250 ml; As per SRO
Approval status of product in Reference Avelox 400 mg/250 ml solution for infusion by M/s Bayer plc,
Me-too status Mofest Infusion 400mg/250ml by M/s Sami (Reg#053227)
Brand Name +Dosage Form + Strength J-Para 1g infusion
Composition Each 100 ml contains:
Paracetamol……….1000mg
Pharmacological Group Analgesic & Antipyretic
Type of Form Form-5
Approval status of product in Reference Acetaminophen (MHRA approved)
Me-too status Bofalgan 1g/100ml Infusion M/s Bosch Pharmaceuticals
Brand Name +Dosage Form + Strength Joxacin 200 mg infusion IV
Composition Each 100 ml vial contains:
Ofloxacin……………….200mg
Pharmacological Group Fluoroquinolone
Type of Form Form-5
Approval status of product in Reference Tarivid Infusion 2mg/ml (MHRA approved)
Me-too status Tariflox Infusion 200mg/100ml by M/s Bosch
Brand Name +Dosage Form + Strength Metzol 500 mg infusion
Metronidazole….500mg (0.5%w/v)
Type of Form Form-5
Approval status of product in Reference Metronidazole infusion 500mg/100ml (TGA)
Me-too status Flagyl infusion 500mg/100ml of M/s Sanofi Aventis
Decision: Approved
410. Name and address of Manufacturer / M/s Maxitech Pharma, factory, E-178,SITE, Karachi.
Applicant
Brand Name+DosageForm+Strength BudeformRotacaps
Diary No. Date of R& I & fee Dy. No.1922, R&I Dated 19-1-17, Rs. 20,000
Budesonide……….400mcg
Formoterol Fumarate…6mcg
Pharmacological Group Corticosteroid/beta adrenergic agonist
Type of Form Form 5
Finished Product Specification innovators
Me-too status (with strength and dosage Combivair of M/s Highnoon labs.
form)
remarks of good cGMP compliance.
Remarks of Evaluator • Evidence of approval of applied formulation in reference
regulatory authorities/agencies.
 Symbicort 0.08MG/INH;0.0045MG/INH
0.16MG/INH;0.0045MG/INH
authorities/agencies as adopted by the Registration Board in its 275th meeting.
411. Name and address of Manufacturer / M/s Maxitech Pharma, factory, E-178,SITE, Karachi.
Applicant
Brand Name+DosageForm+Strength BudeformRotacaps
Budesonide……….200mcg
Formoterol Fumarate…6mcg
Pharmacological Group Corticosteroid/beta adrenergic agonist
Type of Form Form 5
Approval status of product in Reference Symbicort 200 Turbuhaler, by M/s AstraZeneca Health Canada
Me-too status (with strength and dosage Combivair 200/6 Rotacaps by M/s Highnoon
form)
remarks of good cGMP compliance.
Remarks of Evaluator Evidence of rotacaps is not found in Reference Regulatory
Authorities. This formulation is available as Symbicort available
in a multidose inspiratory flow driven, metered dose dry powder
inhaler (Turbuhaler).
Brand Name +Dosage Form + Strength Jawaflox 200 mg infusion
Ciprofloxacin (as HCL)…...200 mg
Type of Form Form-5
Approval status of product in Reference Ciprofloxacin 2mg/ml solution for infusion(MHRA Approved)
Me-too status Qilox 200mg/100ml Infusion by M/s Bosch
Decision: Approved.
413. Name and address of manufacturer / M/s Novamed Pharmaceuticals (Pvt.) Ltd., 28-Km Ferozpur Road,
Applicant Lahore
Brand Name +Dosage Form + Strength Neurocure Capsule 300 mg
Pregabalin …. 300mg
Type of Form Form-5
Approval status of product in Reference Lyrica of (USFDA approved)
Me-too status Gabica Capsule by M/s Getz Pharma
GMP status Firm is compliant to good cGMP guidelines at the time of
inspection as per last inspection conducted on 5-12-2017 & 27-
12-2017.
Remarks of Evaluator Alternative names are,
Neurocure, Axocure, Neurolin
Decision: Approved with change of brand name & with Innovators specifications.
Applicant Lahore
Pregabalin …. 25 mg
Type of Form Form-5
Approval status of product in Reference Lyrica 25mg Capsules M/s by PF Prism (USFDA Approved)
Me-too status Dygab 25mg Capsules by M/s Dyson (Reg#079155)
12-2017.
Neurocure,
Axocure,
Neurolin
Applicant Lahore
Type of Form Form-5
Approval status of product in Reference Lyrica Capsules M/s by PF Prism (USFDA Approved)
12-2017.
Neurocure,
Axocure,
Neurolin
Applicant Lahore
Type of Form Form-5
12-2017.
Neurocure,
Axocure,
Neurolin
Applicant Lahore
Type of Form Form-5
12-2017.
Neurocure, Axocure, Neurolin
418. Name and address of Manufacturer / M/s Scilife Pharma (Pvt) Limited, Plot # FD-57/58-A2, Korangi
Applicant Creek Industrial Park, Karachi
Brand Name+DosageForm+Strength Arixa 2.5 mg tablet
Rivaroxaban ……………2.5mg
Pharmacological Group Anti-thrombtic agent
Type of Form Form 5
Approval status of product in Reference Xarelto 2.5 mg film-coated tablets MHRA Approved
Me-too status (with strength and dosage Xarelto of M/s Baeyer Pharmaceuticals
form)
419. Name and address of manufacturer / M/s Wnsfeild Pharmaceuticals. Plot no. 122, Phase V, Block A,
Applicant Industrial Estate Hattar.
Brand Name +Dosage Form + Strength Rixawin 200mg Tablet
Rifaximin…200mg
Diary No. Date of R& I & fee Dyn# 1115, 11-1-2017, Rs, 20,000/-
Pharmacological Group Anti-Bacterial
Type of Form Form 5
Finished product Specifications Manufacturer specs
Approval status of product in Reference Normicron 200 mg film-coated tablets by MHRA
Me-too status Nifax 200mg Tablet (Reg#076310) by Sami Pharmaceuticals.
GMP status Last GMP Inspection conducted on 18-1-2018 for renewal of
DML.
420. Name and address of manufacturer / M/s. Hamaz Pharmaceuticals (Pvt.) Ltd; 13 km, Bosan road,
Applicant Lutfabad, Multan
Brand Name +Dosage Form + Strength Rockcef Capsule 250 mg
Cephradine monohydrate eq to cephradine…..250mg
Diary No. Date of R& I & fee 7-7-2010, Rs. 8,000/- (14-jun-2010), 12000 (20-1-2015)
Pharmacological Group 1st Generation Cephalosporin
Type of Form Form-5
Approval status of product in Reference Cefradine 250mg Capsules by M/s Athlone Pharmaceuticals
Regulatory Authorities Limited (MHRA Approved)
Me-too status Zasinol 250mg capsule byM/s Martin Dow (Reg#080643)
GMP status Certificate of last, GMP Inspection dated 01.08.2017 with cGMP
compliance.
Decision: Approved
421. Name and address of manufacturer / M/s Dr Raza Pharma,44-C, industrial estate Hayatabad, Peshawar
Applicant
Brand Name +Dosage Form + Strength Lansozol 30 mg capsules
Lansoprazole (as enteric-coated 8.5% pellets)……30 mg
Diary No. Date of R& I & fee Dy.No. 3095, 30-4-2015, Rs.12,000/- (13-01-15), Rs.8000/-, (4-
March- 2011)
Pharmacological Group Anti-Peptic Ulcerant, Proton Pump Inhibitor
Type of Form Form-5
Pack size & Demanded Price 2x7’s / As per SRO
Approval status of product in Reference Lansoprazole 30mg GR capsules of M/s Generics limited (UK
Regulatory Authorities. MHRA Approved)
Me-too status Inhibitol capsules 30mg of M/s Highnoon Laboratories
remarks of cGMP.
Remarks of Evaluator Source of pellets Vision pharma.
Latest GMP
Firm on priority.
422. Name and address of manufacturer / M/s. Weather Fold Pharmaceuticals, 69/2, phase II, industrial area
Applicant Hattar
Brand Name +Dosage Form + Strength Gabafod 400 mg capsule
Gabapentin ………………………400mg
Diary No. Date of R& I & fee Dy. No. 2930; 30-1-2017, Rs. 20,000/-
Type of Form Form-5
Finished product Specifications Manufacture
Approval status of product in Reference Gabapentin 400mg capsule of M/s Actavis Elizabeth (USFDA
Regulatory Authorities Approved)
Me-too status Abapen 400mg capsule of M/s Bosch Pharmaceuticals
(Reg. # 045027)
GMP status Last GMP Inspection dated 15-9-2017 with conclusive remarks
of cGMP compliance.
423. Name and address of manufacturer / M/s. Weather Fold Pharmaceuticals, 69/2, phase II, industrial area
Applicant Hattar
Brand Name +Dosage Form + Strength Gabafod 100 mg capsule
Gabapentin ………………………100mg
Diary No. Date of R& I & fee Dy. No. 2933; 30-1-2017, Rs. 20,000/-
Type of Form Form-5
Finished product Specifications Manufacture
Approval status of product in Reference Gabapentin 100mg capsule of M/s Actavis Elizabeth (USFDA
Me-too status Abapen 100mg capsule of M/s Bosch Pharmaceuticals
(Reg. # 045025)
of cGMP compliance.
424. Name and address of manufacturer / M/s Medizan laboratories (pvt) Ltd. Plot 313, industrial triangle
Applicant Kahuta road, Islamabad
Brand Name +Dosage Form + Strength Zadine 1 mg Tablets
Azatadine…………..1 mg
Pharmacological Group Antihistamine/ Anti-allergic
Type of Form Form-5
Finished Product Specification Manufacturing
As Per SRO
Me-too status NA
remarks of acceptable level of cGMP.
Remarks of Evaluator  Evidence of applied formulation/drug approved by reference
regulatory authorities approved by registration board.
 The provided reference of “Maxigesic” TGA was of different
strength.
• 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 adopted by the Registration Board
425. Name and address of manufacturer / M/s Medizan laboratories (pvt) Ltd. Plot 313, industrial triangle
Applicant Kahuta road, Islamabad
Brand Name +Dosage Form + Strength Patra Rapid 500 Tablets
Paracetamol…………..500 mg
Ibuprofen ……………..200 mg
Pharmacological Group Anti-inflammatory and anti-rheumatic
Type of Form Form-5
Finished Product Specification Manufacturing
Pack size & Demanded Price 6 x 10’s / As Per SRO
Me-too status NA
remarks of acceptable level of cGMP.
Remarks of Evaluator  Evidence of applied formulation/drug approved by reference
regulatory authorities approved by registration board.
 The provided reference of “Maxigesic” TGA was of different
strength.
Decision: Registration Board rejected the application as applied formulation is not approved by any
reference regulatory authority and firm has not submitted safety and efficacy data.
426. Name and address of manufacturer / M/s Pacific Pharmaceuticals,30 km Multan road, Lahore
Applicant
Brand Name +Dosage Form + Strength Valvozid tablet 2.5 mg
Composition Each Film coated tablet contains:
Bisoprolol Fumarate …..2.5 mg
Diary No. Date of R& I & fee Duplicate, 3-05-2016, Rs.20,000/- (Duplicate)
Pharmacological Group Selective beta 1 antagonists
Type of Form Form-5
Pack size & Demanded Price 2x7’s, 2x10’s / As per SRO
Approval status of product in Reference Bisoprolol 2.5 mg film coated tablet (MHRA)
Me-too status Actim of Sami
GMP status Last GMP Inspection conducted on 22-2-2018 GMP inspection
certificate is provided.
Remarks of evaluator
427. Name and address of manufacturer / M/s Crystolite Pharmaceuticals, plot # 1&2, S-2,National
Applicant industrial zone, Rawat Islamabad
Brand Name +Dosage Form + Strength Carbatine 250 mg/5ml syrup
Carbocisteine…..................250mg
Pharmacological Group Mucolytic agent
Type of Form Form 5
Finished product Specifications Innovators specs
Pack size & Demanded Price 120ml and 200 ml; As per SRO
Approval status of product in ReferenceMucodyne Oral solution of M/s Sanofi Aventis (MHRA
Me-too status Zargus of Macter International
GMP status Last inspection report 5-5-2017, Overall GMP Status was good.
Remarks of Evaluator GMP Inspection report conducted on 17th October 2017
concluded that firm is operating at good level of GMP.
428. Name and address of manufacturer / M/s Welmark Pharmaceutical Industries (Pvt) Ltd.
Applicant Plot No. 122, Block B, Phase V Industrial Estate, Hattar,
Brand Name +Dosage Form + Strength Vildamark 50 mg tablet
Vildagliptin……………………50 mg
Pharmacological Group Dipeptidyl peptidase 4 (DPP-4) inhibitors
Type of Form Form 5
Finished product Specifications Innovators
Approval status of product in Reference Vildagliptin 50 mg (TGA Approved)
Me-too status Galvus by Novartis
429. Name and address of manufacturer / M/S Genome Pharmaceuticals (Pvt) Ltd. Plot#16/I-Phase IV,
Applicant Industrial Estate Hattar, KPK, Pakistan
Brand Name +Dosage Form + Strength Furose Tablet
Furosemide…. 40 mg
Amiloride HCl ……. 5 mg
Pharmacological Group Diuretic
Type of Form Form 5
Approval status of product in Reference CO-AMILOFRUSE 40MG/5MG TABLETS Approved by
Regulatory Authorities MHRA of UK
Me-too status Flowride of Scotmann Pharmaceuticals
GMP status Latest GMP dated 12/5/18 with good GMP compliance
430. Name and address of manufacturer / M/s Next pharmaceuticals Plot# 44A and B, Near Tanki #2,
Applicant Sundar industrial estate, Raiwind, Lahore
Brand Name +Dosage Form + Strength Tamlin MR 0.4mg Capsule
Composition Each Capsule contains:
Tamsulosin HCl Extended Release Pellets (0.2%) equivalent to
Tamsulosin HCl … 0.4mg
Pharmacological Group Alpha-I adreno receptor antagonist
Type of Form Form 5
Pack size & Demanded Price 10 x20’s; As per SRO
Approval status of product in Reference Tamsulosin 0.4mg by McDermott Laboratories Ltd. Island
Regulatory Authorities (MHRA approved)
Me-too status Tamsolin 0.4mg by Getz
GMP status GMP Inspection report conducted on 22.02.2018, with
satisfactory GMP
Remarks of Evaluator Formulation is present in USP.
Source of pellets is vision pharma
Decision: Approved
431. Name and address of manufacturer / M/s Pakistan Pharmaceutical Products Pvt Ltd, D-122, S.I.T.E,
Applicant Karachi
Brand Name +Dosage Form + Strength Quesanic 25 mg tablets
Quetiapine (as Fumarate)………………..25 mg
Type of Form Form 5
Approval status of product in Reference Seroquel 25 mg film-coated tablets Approved in MHRA as film-
Regulatory Authorities coated
Me-too status Qutipip Tablet 25mg of M/s Akson Pharmaceuticals
GMP status Copy of inspection conducted on 12-12-2017 concluded that the
firm has complied/improved according to the directions of FID.
Panel was satisfied for the improvements undertaken by the firm
to comply with the observations dated 1st and 2nd August, 2017.
Decision: Approved
432. Name and address of manufacturer / M/s Elite Pharma Pvt Ltd., P.D.H. Street 9.5 km Sheikhupura Road,
Applicant Lahore.
Brand Name +Dosage Form + Strength Betavel ointment 5 gm Tube
Composition Each 5 gm ointment Contains:
Betamethasone as valerate………..0.1%
Pharmacological Group Corticosteroids
Type of Form Form-5
Pack size & Demanded Price 5 gm
As per SRO
Approval status of product in Reference BETA-VAL 0.1% ointment (USFDA)
Me-too status Betacin of Geofman Pharmaceuticals
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.”
Firm on priority and licencing division for licensing status.
433. Name and address of manufacturer / Spencer & Company (Pvt) Ltd., D-105, SITE, Karachi
Applicant
Brand Name +Dosage Form + Strength Speroxat 20 mg tablet
Paroxetine as HCL….20mg
Diary No. Date of R& I & fee Dy.No.1205, 2-05-2017, Rs.20,000/-
Type of Form Form-5
Approval status of product in Reference PAXIL of Apotex (USFDA)
Me-too status Paroxin by M/s. Amarant Pharma, Karachi.
GMP status NA
Applicant
Brand Name +Dosage Form + Strength Speroxat 37.5 mg CR tablet
Composition Each controlled release tablet contains:
Paroxetine as HCL….37.5 mg
Type of Form Form-5
Pack size & Demanded Price 10’s / As per SRO
Approval status of product in Reference Paxil Cr Tablet, Extended Release;Oral By Apotex (USFDA
Me-too status Deroxat CR by Global
GMP status NA
Applicant
Brand Name +Dosage Form + Strength Speroxat 25 mg tablet
Paroxetine as HCL….25 mg
Type of Form Form-5
Pack size & Demanded Price 10’s / As per SRO
Approval status of product in Reference Paxil Cr Tablet, Extended Release;Oral By Apotex (USFDA
Me-too status Deroxat CR by Global
GMP status NA
436. Name and address of manufacturer / M/s Wenovo Pharmaceuticals, Plot # 31-32 Punjab Small Industrial
Applicant Estate, Taxila
Brand Name +Dosage Form + Strength Wenopride 50 mg tablet
Itopride HCl...………………………………...50mg
Pharmacological Group Propulsive
Type of Form Form-5
Finished Product Specification Manufacture
Approval status of product in Reference Ganaton of M/s Abbott Laboratories (PMDA) Japan Approved
Me-too status ITP of M/s Sami Pharmaceuticals
that firm is found complying GMP as of today.
437. Name and address of manufacturer / M/s Glitz Pharma, Plot # 256, industrial triangle, Kahuta Road,
Brand Name +Dosage Form + Strength Fenobar 15 mg Elixir
Diary No. Date of R& I & fee Dy.No. 1982, 27-3-2015, Rs.20,000/-
Phenobarbitone………15 mg
Pharmacological Group Barbiturate, Anticonvulsant
Type of Form Form-5
Pack size & Demanded Price 60ml, 90ml, 120ml, 240ml, 300ml
As Per SRO
Approval status of product in Reference PHENOBARBITAL THORNTON & ROSS 15MG/5ML
Regulatory Authorities. ELIXIR
Me-too status NA
GMP status GMP certificate granted on the basis of inspection conducted on
19-09-2017
Remarks of evaluation The firm change the formulation from 20mg/5 ml to 15 mg/ 5ml
with full 20,000 fee (Dated 28/5/2018) but the evidence of
formulation approved in DRAP is not present in this strength
• Evidence of applied formulation/drug already approved by DRAP (generic / me-too status)
• Evidence of approval of applied formulation in reference regulatory authorities/agencies
438. Name and address of manufacturer / M/s. Don Valley Pharma 39 main peco road,Lahore
Applicant
Brand Name +Dosage Form + Strength Donstan 250mg Tablets
Mefenamic acid….250mg
Pharmacological Group Analgesic, antipyretic and anti-inflammatory agent
Type of Form Form-5
As Per SRO
Me-too status Ponstan 250 mg Tablets by M/s PARK-DAVIS (Reg#000138
GMP status Last GMP Inspection of Don valley Pharmaceuticals. Conducted
on 19-5-17 with conclusive remarks of Fair level of cGMP
compliance.
Remarks of the Evaluator. International evidence in RRA and inspection conducted within 1
year is required.
•Evidence of approval of applied formulation in reference regulatory authorities/agencies which as
adopted by the Registration Board
439. Name and address of manufacturer / M/s. Sharooq Pharma (Pvt.) Ltd, 21 km, Ferozpur road, Lahore.
Applicant
Brand Name +Dosage Form + Strength Aclomin 100mg Tablet
Aceclofenac…..100mg
Diary No. Date of R& I & fee Dy.No.10686, 16-11-2010, Rs.8000/-(16, Nov, 2010), 12,000/-
(26-3-2015)
Type of Form Form-5
Approval status of product in Reference Aceclofenac 100 mg film-coated Tablets by MHRA
Me-too status Acfonac 100mg Tablets by M/s Medicraft Pharmaceuticals (Pvt)
Ltd., (Reg.#081743)
GMP status Last GMP Inspection dated 30-8-2017 for inspection for Renewal
of DML Panel recommends Renewal of DML.
Remarks of Evaluator This formulation is not present in any pharmacopeia.
440. Name and address of manufacturer / M/s Genix Pharma 44, 45-B Korangi creek road, Karachi.
Applicant
Brand Name +Dosage Form + Strength Hepatel 600mg Tablet
Telbivudine…..600 mg
Diary No. Date of R& I & fee Dy.No.2, 1-10-2014, 20,000/-
Pharmacological Group (Antiviral) β-L-nucleoside analogue
Type of Form Form-5
20’s/ As per PRC
Approval status of product in Reference Sebivo 600 mg film-coated tablets (MHRA)
Me-too status Sebivo by Novartis
concludes that firm is operating at satisfactory level of compliance
of GMP.
441. Name and address of manufacturer / M/s Cibex Pvt. Ltd. Factory # 405, SITE, Karachi.
Applicant
Brand Name +Dosage Form + Strength Balin chewable tablet
Composition Each chewable tablets contains:-
Mecobalamin……… 500 mcg
Diary No. Date of R& I & fee Dy. No. 224; 3-1-2017; Rs. 20,000/-
Pharmacological Group Co-enzyme Vit B12
Type of Form Form-5
Finished product Specifications Innovator specs
As per SRO
Approval status of product in Reference NA (Approved in PMDA as sugar coated)
Me-too status Mecomed 500mcg by Global Pharma (Reg. No. 041670) in sugar
coating
GMP status Last GMP Inspection of Cibex Pvt. Ltd conducted on 29-8-17
with conclusive remarks of satisfactory level of cGMP
compliance.
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.
442. Name and address of manufacturer / M/s. Dyson Research laboratories, Lahore.
Applicant
Brand Name +Dosage Form + Strength Magiplus Capsule 6/25 mg
Olanzapine………..6 mg
Fluoxetine (as hydrochloride)…..25 mg
Diary No. Date of R& I & fee Dy.No.1480, 15-01-2011, Rs. 8000/- (12-/june-2011)
Rs. 12,000/- 24-07-2014(Duplicate)
Pharmacological Group Anti-psychotic and a selective serotonin reuptake
Inhibitor
Type of Form Form-5
Approval status of product in Reference Symbyax 6mg/25mg capsule by Eli Lilly (USFDA
Me-too status Co-Depricap 6/25mg Capsule by M/s NabiQasim Industries
Pvt.Ltd. (Reg#076135)
GMP status Last inspection report 1-8-2017with conclusion “panel
Recommended issuance of GMP certificate to the firm.”
443. Name and address of manufacturer / M/s Saffron Pharmaceuticals Pvt Ltd., 19-Km, Sheikhupura Road,
Applicant Faisalabad
Brand Name +Dosage Form + Strength Safavirin 400 mg Capsule
Composition Each Capsule contain
Ribavirin…….400mg
Diary No. Date of R& I & fee Dy.No.1915, 21-10-2016, Rs. 20,000/- (4-10-2016)
Pharmacological Group Anti-Viral

Type of Form Form-5
Me-too status Anti-C 400mg Capsule of M/s Werrick Pharmaceuticals
GMP status Last inspection report 1-8-2017 with conclusion “panel
Recommended issuance of GMP certificate to the firm.”
Remarks of Evaluator  Evidence of approval of applied formulation in reference
meeting.
444. Name and address of manufacturer / Helix Pharma (Pvt) Ltd., Hakimsons House, A/56, S.I.T.E.
Applicant Manghopir Road, Karachi
Brand Name +Dosage Form + Strength PALIX ER Tablets 3 mg
Diary No. Date of R& I & fee Dy.No. Duplication 16-April-2012, 50,000/-
Composition Each enteric coated extended release tablet contains:
rd
179
Paliperidone…………..3 mg
Type of Form Form-5
Finished Product Specification As per innovator
Pack size & Demanded Price As Per SRO
Approval status of product in Reference INVEGA by Janssen Pharmaceuticals
Me-too status Invega by Johnson and Johnson
of acceptable cGMP compliance
Remarks of the Evaluator.  Firm has applied for enteric coated extended release tablet
while, the reference product Invega, approved by USFDA is
prolonged release tablet manufactured using OROS Push-Pull
Technology and the public assessment report describes that
osmotic pressure delivers paliperidone from the dosage form
at a controlled rate. The system, which resembles a capsule-
shaped tablet in appearance, comprises an osmotically active
trilayer core surrounded by a subcoat and semipermeable
membrane. The trilayer core is composed of two drug layers
containing the drug and excipients, and a push layer
containing osmotically active components. There are two
precision laser drilled orifices on the drug-layer dome of the
tablet.
 Approved sections of applicant approved by Licensing Board
and number of products already registered/approved on
contract manufacturing in the name of applicant
Decision: Defered for the clarification of formulation as per reference product.

445. Name and address of manufacturer / M/s. Rakaposhi Pharmaceuticals, 97-K Industrial Estate,
Brand Name +Dosage Form + Strength Gesteron 10 mg tablet
Composition Each Film coated tablet contains:-
Dydrogesteron……10 mg
Diary No. Date of R& I & fee Dy. No.1046; 10-1-2017; Rs. 20,000/-
Pharmacological Group Progestogen
Type of Form Form-5
Approval status of product in Reference Duphaston by BGP Products
Regulatory Authorities (Swissmedic Approved)
Me-too status Duphaston by Abbott
GMP status Last GMP Inspection dated …. with conclusive remarks of good
cGMP compliance.
Remarks of Evaluator Letter was issued to the firm;
 Approval of section/manufacturing facility by the Central
Licensing Board for hormonal products. However, you may
submit panel inspection report for renewal of DML verifying
the section/manufacturing facility
 Latest GMP inspection report (which should have been
conducted within the period of last one year).
 As Firm don’t have approved section so they switch to
contract manufacturing by Aries Pharmaceuticals and revised
fee and dossier is received.
Details are as under
Name and address of manufacturer / M/s. Rakaposhi Pharmaceuticals, 97-K Industrial Estate,
Applicant Hayatabad, Peshawar contract manufacturing by M/s. Aries
Pharmaceuticals (Pvt) Ltd. 1-W, Industrial Estate, Hayatabad
Peshawar, Pakistan
Brand Name +Dosage Form + Strength Gesteron 10 mg tablet
Dydrogesteron……10 mg
Diary No. Date of R& I & fee Dy. No.8122, 5-3-1-2018; Rs. 20,000/- +30000/-
Pharmacological Group Progestogen
Form-5
As per SRO
Approval status of product in Reference Duphaston by BGP Products
Regulatory Authorities (Swissmedic Approved)
Me-too status Duphaston by Abbott
GMP status Last GMP inspection of Aries pharma was conducted on 4-June-
2018 with satisfactory GMP compliance
Remarks of evaluator Rakaposhi is already contract manufacturing 1 product.
Decision: Defered for further delebration on cis/trans isomers of Dydrogesteron
446. Name and address of manufacturer / M/s Swiss Pharmaceuticals A/159, SITE super highway, Karachi
Applicant
Brand Name +Dosage Form + Strength Trimet 35 mg tablet
Diary No. Date of R& I & fee Dy.184, 18-Oct-2010, Rs.12,000/-(6-11-2014), 8000/- (18-Oct-
2010)
Composition Each modified release tablet contains:
Trimetazidine di-hydrochloride …35mg
Pharmacological Group Anti-angina/Ant ischemic
Type of Form Form-5
Pack size & Demanded Price 20’s Rs.300/-
Approval status of product in Reference Trimetazidine EG 35mg MR Tablet by Biogran (ANSM
Me-too status Vastarel-Mr of Servier Research & Pharmaceuticals
GMP status Last GMP Inspection of Conducted on 15/9/17 with conclusive
remarks of good compliance of cGMP.
447. Name and address of manufacturer / M/S Mediate Pharmaceuticals (Pvt) Ltd. Plot No #150-151 Sector
Applicant 24 Korangi, Industrial Area Karachi, Pakistan
Band name Letromed tablet 2.5 mg
Composition Each Film coating tablet contains:
Letrozole …2.5mg
Diary No. Date of R& I & fee Duplicate, 30--8-2017; Rs. 20,000/-
Pharmacological Group Hormone antagonists and related agents (Aromatase inhibitors)
Form Form-5
Approval status of product in Reference Femara 2.5mg coated tablet by M/s Novartis Pharmaceuticals UK
Regulatory Authorities Ltd (MHRA Approved)
Me-too status Aromek Film Coated Tablets 2.5mg by M/s Glaxy Pharma (Pvt)
Ltd (Reg#052258)
GMP status Last Inspection conducted on 15-12-2017and report concludes
that firm is operating at an acceptable level of GMP compliance.
Brand Name +Dosage Form + Strength Cefafin IM injection 1gm
Ceftriaxone (as ceftriaxone sodium)…..….1 gm
Diary No. Date of R& I & fee Duplicate, 30-8-2017; Rs. 20,000/-
Form Form-5
Pack size & Demanded Price Cephalosporin
Approval status of product in Reference Ceftriaxone of sandoz (USFDA)
Me-too status 3-zone of Zeb Pharma
Brand Name +Dosage Form + Strength Cefafin IM injection 500 mg
Ceftriaxone (as ceftriaxone sodium)…..….500 mg
Form Form-5
Brand Name +Dosage Form + Strength Cefafin IM injection 250 mg
Ceftriaxone (as ceftriaxone sodium)…..….250 mg
Form Form-5
Brand Name +Dosage Form + Strength Lidocaine 2 ml injection
Lidocaine Hydrochloride………10mg
Pharmacological Group Anesthesia
Form Form-5
Approval status of product in Reference Lidocaine Hydrochloride solution for Injection 1% w/v of M/s
Regulatory Authorities Accord Health Care, UK (MHRA Approved)
Me-too status Lidocaine 1% Injection of M/s Zafa Pharmaceuticals (Reg. #
030216)
452. Name and address of manufacturer / Cirin Pharmaceuticals (Pvt) Ltd., 32/2-A, Phase-III, Industrial
Applicant Estate Hattar, District Haripur KPK
Brand Name +Dosage Form + Strength Ziten 100 mg tablet
Sitagliptin as phosphate monohydrate …………100 mg
Type of Form Form-5
As per SRO
Approval status of product in Reference Januvia by MSD (USFDA)
Me-too status Sita of Pharm Evo
GMP status Last inspection conducted on 7-May-2018 and report concludes
that firm is found complying at Good GMP.
Decision: Approved
Sitagliptin as phosphate……………………50 mg
Type of Form Form-5
As per SRO
Decision:Approved
Sitagliptin as phosphate……………………25 mg
Type of Form Form-5
As per SRO
Decision: Approved
455. Name and address of manufacturer / M/s NabiQasim Industries (Private) Limited, 17/24, Korangi
Applicant Industrial Area, Korangi, Karachi
Brand Name +Dosage Form + Strength Descol EZ 10/20 mg tablet
Ezetimibe …. 10mg
Atorvastatin as calcium Trihydrate …. 20mg
Diary No. Date of R& I & fee D#15646, 20-9-2017; Rs. 20,000/-
Pharmacological Group Lipid Modifying Agents
Form Form-5
As per SRO
Approval status of product in Reference Ezetimibe and Atorvastatin Calcium (USFDA)
Me-too status Atozet of Hilton Pharma (Pvt) Limited
GMP status Last Inspection report 15-09-2017 Firm has acceptable level of
GMP.
Decision: Approved
456. Name and address of manufacturer / M/s. Dyson Research laboratories, Lahore.
Applicant
Brand Name +Dosage Form + Strength Magiplus Capsule 3/25mg
Diary No. Date of R& I & fee Dy.No.1481,15-01-2011, Rs. 8000/- 01-02-2011
Rs. 12,000/- 24-07-2014
Composition Composition Each capsule contains:-
Olanzapine………..3mg
Fluoxetine (as hydrochloride)…..25mg
Pharmacological Group Anti-psychotic and a selective serotonin reuptake
Inhibitor
Type of Form Form-5
Approval status of product in Reference Symbyax by Eli Lilly (USFDA Approved)
Me-too status NA
GMP status Last GMP Inspection of Conducted on … with conclusive
remarks of compliance of cGMP.
Remarks of the Evaluator.  Latest GMP inspection report (which should have been
• Evidence of me too
Evaluator PEC-IV
457. Name and address of manufacturer / M/s OBS Pakistan Private Limited
Applicant Contract manufactured by: AGP Limited B-23, S.I.T.E., Karachi
Brand Name +Dosage Form + Strength Obstam 1gm/5ml Injection
Piracetam………1gm
Diary No. Date of R& I & fee Dy.No. 18-06-2015 ; Rs. 50,000 (Duplicate Dossier)
Pharmacological Group Cerebral Stimulant
Type of Form Form 5
Finished product Specifications Manufacturers specifiaction
Pack size & Demanded Price 5ml; Rs; 800/10’s, Rs; 960/12’s
Approval status of product in Not found
Me-too status (with strength and Piractim Injection M/s Global Pharmaceuticals
dosage form)
GMP status Last inspection was conducted on 15.11.2017 and report
concludes that firm was GMP compliant
Remarks of the Evaluator  Evidence of approval of applied formulation and applied
were declared/approved by the Registration Board in its
275th meeting.
 Firm provided Nootropil in Italy but it is revoked
(Nootropyl in France repealed but 3gm/15ml is valid)
458. Name and address of manufacturer / Legacy Pharmaceuticals, Peshawar
Applicant
Brand Name +Dosage Form + Strength Pirozin 20mg Tablets
Piroxicam-beta-cyclodextrin equivalent to Piroxicam….20mg
Diary No. Date of R& I & fee Dy.No. Rs.8000/- dated 21-1-2011 Rs.12000/- dated 4-8-2015
Pharmacological Group (Antirheumatic)
Type of Form Form 5
Pack size & Demanded Price 20’s; Rs.175.00
Approval status of product in Cycladol tablet ( ANSM approved)
Me-too status (with strength and Pirujin Tablet M/s Jupiter Pharma
dosage form)
GMP status Last Inspection conducted on 30-03-2017 for grant of additional 3
section , panel recommend grant of additional section and overall
evaluation of the inspection report is good
Remarks of the Evaluator Latest GMP inspection report (conducted within the period of last
one year).
Decision: Registration Board referred the case to QA & LT Division to conduct GMP inspection of Firm
on priority.
459. Name and address of manufacturer / Brookes Pharma Pvt Ltd Karachi
Applicant
Brand Name +Dosage Form + Strength Mincal-D Tablet
Ossein Mineral complex…830mg
Vitamin d………….400 IU
Diary No. Date of R& I & fee Dy.No. Dy.No.398; Rs.20,000/- 07-05-2014
(Dupplicate dossier)
Pharmacological Group Minerals & Vitamins
Type of Form Form 5
Pack size & Demanded Price 30’s/ as per SRO
Me-too status (with strength and Osam-D Tablet Of M/s Getz Pharma
dosage form)
GMP status Last inspection was conducted on 11.10.2017 & 16-10-2017 and
report concludes that firm was considerd to be operating at
satisfactory level of GMP compliance
Remarks of the Evaluator Evidence of approval of applied formulation in reference regulatory
authorities/agencies which were declared/approved by the
Registration Board in its 275th meeting.
Decision Deferred for evidence of approval of applied formulation in reference regulatory
460. Name and address of manufacturer / M/s Hicon Pharmaceuticals, 131- Industrial Estate, Hayatabad.
Applicant
Brand Name +Dosage Form + Strength Monticon 10mg Tablet
Montelukast as sodium Eq to Montelukast USP……10mg
Diary No. Date of R& I & fee Dy.No.10503; 31-07-2017; Rs.20,000/- (31-07-2017)
Pharmacological Group Anti-asthmatic
Type of Form Form 5
Pack size & Demanded Price 2 x 7’s ; As per SRO
Approval status of product in Singulair Of (USFDA Approved)
Me-too status (with strength and Mecost 10mg Tablet M/sSigma
dosage form)
GMP status Last GMP inspection is conducted on 26- 07- 17 and the report
concludes that overall firm is working under satisfactory level of
cGMP.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Relaxit 2mg Tablet
Tizanidine HCl……2mg
Pharmacological Group Skeletal Muscle relaxant
Type of Form Form 5
rd
186
Approval status of product in Tizanidine of MHRA approved
Me-too status (with strength and Mecost 10mg Tablet M/sSigma
dosage form)
GMP status Last GMP inspection is conducted on 26- 07- 17 and the
report concludes that overall firm is working under satisfactory level
of cGMP
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Lezet 5mg Tablet
Levocetirizine Dihydrochloride……5mg
Type of Form Form 5
Approval status of product in Xyzal of USFDA approved
Me-too status (with strength and Cerigex-L Tablet 5mg M/s Fedro Pharmaceutical,
dosage form)
cGMP
Remarks of the Evaluator  Firm change the formulation.from uncoated to film coated
form without submission of fee.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Itocon 50mg Tablet
Composition Each film tablet contains:-
Itopride Hydrochloride……50mg
Pharmacological Group Prokinetics
Type of Form Form 5
Approval status of product in PMDA Japan
Me-too status (with strength and Xepride Tablets M/sUsawa Pharmaceuticals,
dosage form)
GMP status Last GMP inspection is conducted on 26-07-17 & report concludes
that overall firm is working under satisfactory level of cGMP
Applicant
Brand Name +Dosage Form + Strength Glim 4mg Tablet
Glimepiride USP……4mg
Pharmacological Group Antidiabetic
Type of Form Form 5
Approval status of product in Amaryl 4mg tablets of MHRA approved
Me-too status (with strength and Glimera 4mg Tablet M/sPPP
dosage form)
cGMP
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength B- Fen DS 200mg/5ml Suspension
Ibuprofen USP……200mg
Pharmacological Group NSAID, Antipyretic
Type of Form Form 5
Pack size & Demanded Price 1 x 90ml & 1 x 120ml ; As per SRO
Approval status of product in IBuprofen 200mg/5ml Oral Suspension of MHRA approved
Me-too status (with strength and Kata-DS Suspension M/sCibex Pharmaceuticals
dosage form)
cGMP
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Lezet 2.5mg/ 5ml Syrup
Composition Each 5ml contains
Levocetirizine dihydrochloride………2.5mg
Type of Form Form 5
Finished product Specifications Manufacture’s specification
Pack size & Demanded Price 60ml ;As As per SRO
Approval status of product in Xyzal of (MHRA approved)
Me-too status (with strength and Concidol-L Syrup of M/s Convell Laboratories
dosage form)
cGMP
Decision: Approved with Innovator’s specification.
467. Name and address of manufacturer / M/s Reliance Pharama, Plot No. 8, Street No. S-8 RCCI Industrial
Applicant State, Rawat- Pakistan.
Contract Manufactured by: M/s EG Pharmaceuticals Plot No. 13-A,
Industrial Triangle, Kahuta Road, Islamabad.
Brand Name +Dosage Form + Strength E- REL 2gm injection I.V
Ceftriaxon Sodium equivalent to ceftriaxone
USP……….2gm
Type of Form Form-5
Approval status of product in Ceftriaxone of MHRA approved
Me-too status (with strength and Triax 2gm Injection of M/s. Wilshire Laboratories
dosage form)
the report concludes that overall firm is operating at reasonable level
&
Last GMP inspection of Reliance conducted on 27-04- 2018 for
renewal of DML and panel recommend for approval of revised
layout plan and renewal of DML and overall evalution of inspection
report is Good.
Remarks of the Evaluator  Contract manufacturing agreement: attached
 Number of sections of applicant approved by Licensing Board: 04
 Number of products already registered/approved on contract
manufacturing in the name of applicant.: 02
468. Name and address of manufacturer / M/S Medisave Pharmaceuticals Plot No: 578-579 Sundar Industrial
Applicant Estate, Sundar Raiwind Road, Lahore - Pakistan
Brand Name +Dosage Form + Strength Thiocol 4mg/2ml Injection IV
Composition Each 2ml ampoule contain
Thiocolchicoside..……4mg
Pharmacological Group Muscle Relaxant
Type of Form Form 5
Pack size & Demanded Price 1 ’s, 5’s, 6’s ; As per SRO
Approval status of product in ANSM approved
Me-too status (with strength and Muscoril Injection 2ml By M/S Sanital Pharmaceutical
dosage form)
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.
469. Name and address of manufacturer / M/S Welwrd Pharmaceuticals, Plot No ; 3, Block A, Phase I – II,
Applicant Industrial Estat,Hattar, Pakistan
Brand Name +Dosage Form + Strength Welphene 50mg tablet
Clomiphene citrate..…………50mg
Pharmacological Group Anti-estrogen
Type of Form Form 5
Approval status of product in Clomid of (USFDA approved)
Me-too status (with strength and Kins Tablets by Stanley Pharmaceuticals
dosage form)
GMP status Last GMP inspection of Welwrd conducted on 14-06-2017 and the
report concludes that firm is GMP compliant.
which remain in direct contact or are involved in close handling of these drugs
470. Name and address of manufacturer / M/s Akson Pharmaceuticals (Pvt) Ltd, Plot9B-1 & 2, Sector D/I, Old
Applicant Industrial Area, Mirpur, Azad Kashmir
Contract Manufactured by: M/s Safe Pharmaceuticals (Pvt) Ltd. Plot
No C.I-20, and Sector 6- B, north Karachi industrial Area, Karachi.
Brand Name +Dosage Form + Strength Noran 20mg injection
Omeprazole Sodium (U.S.P) equivalent to Omeprazole
……….20mg
Type of Form Form 5
Pack size & Demanded Price 1’s ; As per SRO
Me-too status (with strength and Zolpro Injection of M/s Safe Pharmaceuticals,(Registration No:
dosage form) 070826)
GMP status Last inspection of Akson Pharmaceuticals was conducted on 16-
06- 17 & 25-07-2017 for renewal of DML and panel recommend
renewal of DML
&
Last inspection of Safe Pharmaceuticals conducted on 07-04-
2018 for renewal of DML and panel recommend renewal of DML
and the report concludes that overall evalution of inspection report
is rated as Good.
Remarks of the Evaluator  Contract manufacturing agreement: Attached
 Number of sections of applicant approved by Licensing Board:
08
manufacturing in the name of applicant: 22
 Evidence of approval of applied formulation in reference
 Firm provided Mepral injection Italy but not confirmed
No C.I-20, And Sector 6- B, North Karachi Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Noran 40mg injection
……….40mg
Type of Form Form 5
Approval status of product in Omeprazol 40mg injection of (MHRA approved)
Me-too status (with strength and Fymezole Dry Powder Injection IV of M/s Fynk Pharmaceuticals
dosage form)
GMP status Last inspection of Akson Pharmaceuticals was conducted on 16-6-
17 & 25-07-2017 for renewal of DML and panel recommend
renewal of DML
&
is rated as Good.
 Number of sections of applicant approved by Licensing
Board : 08
Brand Name +Dosage Form + Strength E-Mepra 20mg injection
Esomeprazole Sodium (U.S.P) equivalent to Esomeprazole
……….20mg
Type of Form Form 5
Approval status of product in Nexium IV injection of (USFDA approved)
Me-too status (with strength and ES-Loprot 20mg I.V Injection of M/s Nabiqasim
dosage form)
GMP status Last inspection of Akson Pharmaceuticals was conducted on 16- 06-
renewal of DML
&
is rated as Good.
Board : 08
Brand Name +Dosage Form + Strength E-Mepra 40mg injection
Esomeprazole Sodium (USP) eq. to Esomeprazole…….40mg
Type of Form Form 5
Me-too status (with strength and Esold Injection of M/s Weather Folds Pharmaceutical
dosage form)
GMP status Last inspection of Akson Pharmaceuticals was conducted on 16-6-
renewal of DML
&
Last inspection of Safe Pharmaceuticals conducted on 07-04- 2018
for renewal of DML and panel recommend renewal of DML and the
report concludes that overall evalution of inspection report is rated
as Good.
Board : 08
Brand Name +Dosage Form + Strength Progard 40mg injection
Pantoprazole Sodium (USP) eq. to Pantoprazole ……….40mg
Type of Form Form 5
Approval status of product in Protonix injection of (USFDA approved)
Me-too status (with strength and Pazole Dry Powder Injection IV of M/s Fynk Pharmaceuticals,
dosage form)
GMP status Last inspection of Akson Pharmaceuticals was conducted on 16-
06- 17 & 25-07-2017 for renewal of DML and panel recommend
renewal of DML
&
is rated as Good.
Board : 08
475. Name and address of manufacturer / M/S Wimits Pharmaceuticals Plot no 129, Sundar Industrial Estate,
Applicant Sundar Raiwind Road, Lahore - Pakistan
Brand Name +Dosage Form + Strength Ligwim 1% Injection
Lignocain HCl...…………10mg
Pharmacological Group Local anaesthetic
Type of Form Form 5
Pack size & Demanded Price 2ml x 100’s ; As per SRO
Approval status of product in Lidocaine Injection 1% w/v (MHRA approved)
Me-too status (with strength and Lacain 1% Injection of M/s. Pulse Pharmaceuticals
dosage form)
GMP status Certificate of cGMP certificate on the basis of inspection
conducted on 03-11-2017
Decision: Approved.
476. Name and address of manufacturer / M/S Wimits Pharmaceuticals Plot no 129, Sundar Industrial Estate,
Applicant Sundar Raiwind Road, Lahore - Pakistan
Brand Name +Dosage Form + Strength Ligwim 2% Injection
Lignocain HCl..…………20mg
Pharmacological Group Local anaesthetic
Type of Form Form 5
Pack size & Demanded Price 2ml, 5ml, 10ml, 20ml ;; As per SRO
Approval status of product in Lidocaine Injection 2% w/v (MHRA approved)
Me-too status (with strength and Lacain 2% Injection of M/s. Pulse Pharmaceuticals
dosage form)
GMP status Certificate of cGMP certificate on the basis of inspection
Decision: Approved.
477. Name and address of manufacturer / M/S Welmark Pharmaceuticals, Plot No ; 122, Block B, Phase V,
Brand Name +Dosage Form + Strength Welmet Plus 50mg/500mg Tablet
Metformin HCl………500mg
Pharmacological Group Antihyperglycemic agent
Type of Form Form 5
Finished product Specifications Manufacturer specification
Pack size & Demanded Price AS per SRO ; As per SRO
Approval status of product in Galvumet Tablet Of (TGA Approved)
Me-too status (with strength and Galmet 50mg/500mg Table M/s Vision Pharmaceuticals,
dosage form)
GMP status Last GMP inspection conducted on 16-09-2017 ,and the
report concludes that overall firm was GMP compliant
Remarks of the Evaluator  Shelf life of 18 months with packaging
material of PA/Al/PVC/Al -polyamide-aluminum foil-
polyvinylchloride/aluminum foil or
PCTFE/PVC/Alu or 2 years with PA/Alu/PVC/Alu.
Brand Name +Dosage Form + Strength Welmet Plus 50mg/1000mg Tablet
Metformin HCl………1000mg
Type of Form Form 5
Pack size & Demanded Price AS per SRO ; As per SRO
Approval status of product in Galvumet Tablet Of (TGA Approved)
Me-too status (with strength and Vilget-M 50mg+1000mg Tablet M/s Getz
dosage form)
Remarks of the Evaluator Shelf life of 18 months with packaging
material of PA/Al/PVC/Al -polyamide-aluminum foil-
polyvinylchloride/ aluminum foil or
PCTFE/ PVC/ Alu or 2 years with PA/Alu/PVC/Alu.
Brand Name +Dosage Form + Strength Flucowel 150mg Capsule
Fluconazole………150mg
Type of Form Form 5
Approval status of product in Azocan 150capsule Of (MHRA Approved)
Me-too status (with strength and Cozole 150mg Capsule M/s Epharm Lab
dosage form)
Brand Name +Dosage Form + Strength Hydromark 2% Ophthalmic drops
Hydroxypropyl Methylcellulose ………60mg (2% w/w)
Pharmacological Group Lubricant, Ocular
Type of Form Form 5
Pack size & Demanded Price 3ml x 1’s ; As per SRO
Approval status of product in Cellugel ophthalmic/fiscosurgical Device (OVD)of USFDA
Reference Regulatory Authorities approved
Me-too status (with strength and Ophth-Biovisc Surgical Adjunct M/ Ophth Pharma
dosage form)
481. Name and address of manufacturer / M/S Aspin Pharma (Pvt) Ltd., Plot No. 10 & 25. Sector 20, Korangi
Brand Name +Dosage Form + Strength Denfos 70mg Tablet
Alendronate Sodium Trihydrate 91.35mg Eq to Alendronic
acid …………70mg
Pharmacological Group Bisphosphonate ( Antiosteoporotic)
Type of Form Form 5
Pack size & Demanded Price 4’s, 10’s ;As per SRO
Approval status of product in Alendronic Acid 70mg of MHRA approved
Me-too status (with strength and Bonafide Tablets 70mg by M/s Medisure Labs.
dosage form)
GMP status The last GMP inspection conducted on 02-02-2018 and report
concludes that firm was considered to be operating at satisfactory
482. Name and address of manufacturer / M/S Highnoon Laboratories Ltd. 17.5 Kilometer, Multan Road
Applicant Lahore
Brand Name +Dosage Form + Strength Olmisan-AM 20mg/5mg Tablet
Composition Each film coated tablet contain
OLmesartan medoxomil… …….20mg
Amlodipine besylate………….5mg
Pharmacological Group Anti hypertension
Type of Form Form 5
Pack size & Demanded Price 10’s, 14’s, 28’s, 56’s ; As per SRO
Approval status of product in Azor 20mg/5mg tablets Of ( USFDA Approved)
Me-too status (with strength and Baritec-A 20/5mg Of M/S Barret Hodgson
dosage form)
GMP status Last GMP inspection is conducted on - 02- 2018 and the report
concludes that firm was considerd to be operating at Good level of
compliance with GMP.
Applicant Lahore
Amlodipine besylate…………10mg
Type of Form Form 5
Approval status of product in Azor 20mg/10mg tablets Of ( USFDA Approved)
Me-too status (with strength and Baritec-A 20/10mg Of M/S Barret Hodgson
dosage form)
compliance with GMP
Applicant Lahore
Amlodipine besylate…………5mg
Type of Form Form 5
Approval status of product in Azor 40mg/5mg tablets Of (USFDA Approved)
Me-too status (with strength and Baritec-A 40mg/5mg Of M/S Barret Hodgson
dosage form)
compliance with GMP
485. Name and address of manufacturer / M/S Nabiqasim Industries (Pvt) Ltd., 17/24, Korangi , Industrial
Applicant Area, Karachi, Pakistan
Brand Name +Dosage Form + Strength Tygatral 50mg IV Injection
Tigecyclin ……….50mg
Pharmacological Group Tetracycline
Type of Form Form 5
Approval status of product in Tygacil of ( USFDA Approved)
Me-too status (with strength and Tilane 50mg Injection of M/S S.J&G
dosage form)
GMP status Last GMP Inspection conducted on 02-11-2017 and
report concludes that firm is found good level of GMP
compliance.(PSI)
Decision: Deferred for clarification of applied dosage form whether lyophiloized powder or lyophilized
cake.
486. Name and address of manufacturer / M/S NOA Hemis Pharmaceuticals, Plot No: 154, Sector-23,
Applicant Korangi , Industrial Area, Karachi, Pakistan
Brand Name +Dosage Form + Strength Xaglip 2.5mg Tablet
Saxagliptin ……….2.5mg
Duplicate Dossier
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s ; As per SRO
Approval status of product in Onglyza of (USFDA Approved)
Me-too status (with strength and Saxagen 2.5mg Tablet of M/S Genix
dosage form)
GMP status Last GMP Inspection conducted on 14-06-2017 and report
concludes that firm is considerd to be operating at an acceptable
level of GMP compliance
Decision: Registration Board deferred the case for clarification to avoid cycisation process. The Board,
further decided to get clarification from previous registration holders of same formulation.
487. Name and address of manufacturer / M/S NOA Hemis Pharmaceuticals, Plot No: 154, Sector-23,
Applicant Korangi , Industrial Area, Karachi, Pakistan
Brand Name +Dosage Form + Strength Xaglip 5mg Tablet
Saxagliptin ……….5mg
Duplicate Dossier
Type of Form Form 5
Approval status of product in Onglyza of ( USFDA Approved)
Me-too status (with strength and Saxagen 2.5mg Tablet of M/S Genix
dosage form)
GMP status Last GMP Inspection conducted on 14-06-2017 and report
concludes that firm is considerd to be operating at an acceptable
level of GMP compliance
Decision: Registration Board deferred the case for clarification to avoid cycisation process. The Board,
further decided to get clarification from previous registration holders of same formulation.
488. Name and address of manufacturer / M/S High –Q Pharmaceuticals, Plot No ; 224/23 Korangi Industrial
Applicant Area, Karachi.
Brand Name +Dosage Form + Strength Lornecam 4mg Tablet
Lornoxicam… …….4mg
Type of Form Form 5
Approval status of product in Xefo 4 mg tablet (EMA approved)
Me-too status (with strength and LoxiBar 4mg Tablet Of M/S Barret Hodgson
dosage form)
GMP status Last GMP inspection was conducted on 19-07-2017
and the report shows grant of GMP certificate.
489. Name and address of manufacturer / M/S High –Q Pharmaceuticals, Plot No; 224/23 Korangi Industrial
Brand Name +Dosage Form + Strength Lornecam 8mg Tablet
Type of Form Form 5
Me-too status (with strength and Loxi Bar 8mg Tablet Of M/S Barret Hodgson
dosage form)
490. Name and address of manufacturer / M/S High –Q Pharmaceuticals, Plot No ; 224/23 Korangi Industrial
Brand Name +Dosage Form + Strength Acelof 100mg Tablet
Aceclofenac (BP)… …….100mg
Type of Form Form 5
Approval status of product in Preservex 100 Mg (MHRA approved)
Me-too status (with strength and Dysofenac Table Of M/S Dyson Research Laboratories
dosage form)
491. Name and address of manufacturer / M/S Hilton Pharma (Pvt) Ltd. Plot No. 13-14, Sector 15, Korangi
Brand Name +Dosage Form + Strength Himet XR 1000mg Tablet
Composition Each film coated extended release tablet contain:
Metformin hydrochloride… …….1000mg
Pharmacological Group Anti diabetic
Type of Form Form 5
Pack size & Demanded Price 10’s, 14’s, 20’s, 28’s, 30’s ; As per SRO
Approval status of product in Fortamet Tablet Of ( USFDA Approved)
Me-too status (with strength and Dowphage ER 1000mg Tablet of M/S Martin Dow
dosage form)
GMP status Inspection report 19-7-2017 firm was considered to be Operating at
satisfactory level of compliance with GMP.
Decision: Approved.
492. Name and address of manufacturer / M/S Hilton Pharma (Pvt) Ltd. Plot no. 13-14, Sector 15, korangi
Brand Name +Dosage Form + Strength Apret 40mg Capsule
Aprepitant… …….40mg
Pharmacological Group Anti-emetic agent
Type of Form Form 5
Approval status of product in Emend Of ( USFDA Approved)
Me-too status (with strength and Apritus 40mg Capsule Of M/S S.J&G
dosage form)
GMP status Inspection report 19-7-2017 firm was considered to be operating at
Decision: Approved.
Composition Each capsule contain:
Type of Form Form 5
dosage form)
operating at satisfactory level of compliance with GMP.
Decision: Approved.
Composition Each capsule contain
Type of Form Form 5
dosage form)
GMP status Inspection report 19-7-2017 firm was considered to be operating at
Decision: Approved.
495. Name and address of manufacturer / M/S UDL Pharmaceuticals. Plot No. E-44 & E-45, North Western
Applicant Industrial Zone, Port Qasim Authority, Karachi.
Brand Name +Dosage Form + Strength Diartin 40mg/320mg Tablet
Dihydroartemisnin……..40mg
Piperaquine Phosphtel………320mg
Diary No. Date of R& I & fee Dy.No.10267; 27-07-2017; Rs.20,000/- (27-07-2017
Pharmacological Group Anti malarial
Type of Form Form 5
Pack size & Demanded Price 8’s, ; As per SRO
Approval status of product in WHO prequalified
Me-too status (with strength and Antimal-Rapid 40/320 Tabletof M/s Pharmevo
dosage form)
concludes resumption of production operations accordingly.
Brand Name +Dosage Form + Strength Xarofaz 4mg Tablet
Type of Form Form 5
dosage form)
Brand Name +Dosage Form + Strength Xarofaz 8mg Tablet
Type of Form Form 5
dosage form)
Brand Name +Dosage Form + Strength Feburic 40mg tablet
Febuxostat……..40mg
Pharmacological Group Antigout preparation(Non-purine xanthine oxidase Inhibitor)
Type of Form Form 5
Pack size & Demanded Price 20’s & 30’s ; As per SRO
Approval status of product in Uloric 40mg Tablet of (USFDA approved)
dosage form)
Brand Name +Dosage Form + Strength Feburic 80mg tablet
Febuxostat……..80mg
Pharmacological Group Antigout preparation(Non-purine xanthine oxidase Inhibitor)
Type of Form Form 5
Pack size & Demanded Price 20’s & 30’s ; As per SRO
Approval status of product in Uloric 80mg Tablet of (USFDA approved)
dosage form)
Brand Name +Dosage Form + Strength Pyclodex 20mg tablet
Piroxicam as ( Beta Cyclodextrin)……….20mg
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s , ; As per DRAP policy
Approval status of product in Cycladol 20 mg Tablets of ( ANSM approved)
Me-too status (with strength and Pirujin Tablet M/s Jupiter Pharma
dosage form)
Brand Name +Dosage Form + Strength Movadine 2mg Tablet
Type of Form Form 5
Me-too status (with strength and Tandolax 2mg Tablet M/s High-Q Pharmaceuticals
dosage form)
Decision: Approved.
Brand Name +Dosage Form + Strength Movadine 4mg Tablet
Type of Form Form 5
dosage form)
Decision: Approved.
Brand Name +Dosage Form + Strength Zandon 5mg Tablet
Serratiopeptidase…..5mg
Pharmacological Group Anti-inflammatory proteolytic enzyme
Type of Form Form 5
Pack size & Demanded Price 20’s,; As per SRO
Approval status of product in Could not found
Me-too status (with strength and Korzen tablet of M/s ST.John karachi
dosage form)
Remarks of the Evaluator  Evidence of approval of applied formulation in reference
 According to 245th meeting, Serratiopeptidase is a proteolytic
enzyme present in silkworm gut which helps it to dissolve the
cocoon. It has been used as an anti-inflammatory agent without
any scientific evidence of efficacy. Takeda Pharmaceuticals, the
brand leader Japanese company, had
agreed for voluntary withdrawal from market in 2011.Not
recommended for registration
Decision: Registration Board deferred for further deliberation.
Type of Form Form 5
Me-too status (with strength and Danzen tablet of M/s Helix
dosage form)
Type of Form Form 5
Me-too status (with strength and Not found
dosage form)
by the Registration Board in its 275th meeting
DRAP (generic / me-too status) alongwith registration number,
brand name and name of firm
506. Name and address of manufacturer / M/S Lisko Pakistan (Pvt) Ltd. L-10-D Block-21 Shaheed Rashid
Brand Name +Dosage Form + Strength Claricure 250mg Tablet
Clarithromycine……….250 mg
Diary No. Date of R& I & fee Dy.No.9795`; 24-07-2017; Rs.20,000/- (24-07-2017)
Type of Form Form 5
Approval status of product in Klaricid of (MHRA approved)
Me-too status (with strength and Respect tabletM/s Spencer Pharmaceutical
dosage form)
GMP status Last GMP inspection is conducted on 24- 04- 2018 & report
concludes that overall firm has satisfactory level of GMP
compliance.
Brand Name +Dosage Form + Strength Claricure SR 500mg Tablet
Clarithromycine……….500 mg
Type of Form Form 5
Approval status of product in Klaricid of (MHRA approved)
Me-too status (with strength and Respect tabletM/s Spencer Pharmaceutical
dosage form)
compliance.
Moreover Registration Board directed the firm to submit clarification regfarding applied dosage form
whther sustained release or otherwise
Brand Name +Dosage Form + Strength Tizin 4mg Tablet
Type of Form Form 5
dosage form)
compliance.
Brand Name +Dosage Form + Strength Fluco 50mg Capsule
rd
205
Type of Form Form 5
Approval status of product in GA Azocan 50mg capsule Of (MHRA Approved)
Me-too status (with strength and Fiscon Capsules 50mg M/s Fassgen Pharmaceuticals
dosage form)
report concludes that overall firm has satisfactory level of GMP
compliance.
Brand Name +Dosage Form + Strength Fluco 200mg Capsule
Type of Form Form 5
Approval status of product in GA Azocan 200mg capsule Of (MHRA Approved)
Me-too status (with strength and Fcozole 200mg Capsules M/s Medicraft pharmaceuticals
dosage form)
compliance.
Brand Name +Dosage Form + Strength Fexin 60mg Tablet
Fexofenadine HCl..………60mg
Pharmacological Group Anti histamines
Type of Form Form 5
Approval status of product in GA Fexofenadine hydrochloride tablets by Mylan
Reference Regulatory Authorities (USFDA Approved)
Me-too status (with strength and Epodin 60mg Tablet M/s Epoch Pharmaceutical,
dosage form)
compliance.
Brand Name +Dosage Form + Strength Fexin 120mg Tablet
Fexofenadine HCl..………120mg
Pharmacological Group Anti histamines
Type of Form Form 5
Approval status of product in GA Fexofenadine hydrochloride tablets by (MHRA Approved)
Me-too status (with strength and Epodin 120mg Tablet M/s Epoch Pharmaceutical,
dosage form)
compliance.
Brand Name +Dosage Form + Strength Bezo 2.5 mg Tablet
Bisoprolol fumerate..………2.5mg
Pharmacological Group Anti-hypertensive (Selective B1 adrenergic receptor blocker)
Type of Form Form 5
Approval status of product in GA Cardicor 2.5mg tablet Of ( MHRA Approved)
Me-too status (with strength and Biscot 2.5mg Tablet Of M/S Scotmann Pharmaceuticals,
dosage form)
compliance.
Brand Name +Dosage Form + Strength Bezo 5 mg Tablet
Bisoprolol fumerate..………5mg
Type of Form Form 5
Approval status of product in GA Cardicor 2.5mg tablet Of ( MHRA Approved)
Me-too status (with strength and Biscot 2.5mg Tablet Of M/S Scotmann Pharmaceuticals,
dosage form)
compliance.
Brand Name +Dosage Form + Strength Glucomin 50mg/1000mg Tablet
Sitagliptin (as phosphate monohydrate) ………50mg
Metformin hydrochloride……………850mg
Pharmacological Group Antihyperglycemic
Type of Form Form 5
Approval status of product in Janumet tablets of (TGA approved)
Me-too status (with strength and S-Gliptin Plus Tablets of M/s Barrett Hodgson
dosage form)
compliance.
Brand Name +Dosage Form + Strength Valsart plus 10mg/160mg/12.50mg Tablet
Amlodipine as (Besylate)……….10mg
Hydrochlorothiazide……..12.5mg
Pharmacological Group Anti-hypertensive
Type of Form Form 5
Approval status of product in Exforge Hct Of ( USFDA Approved)
Me-too status (with strength and Exforge Hct Of M/S Novartis Pharma
dosage form)
compliance.
Brand Name +Dosage Form + Strength Valsart plus 5mg/160mg/12.50mg Tablet
Amlodipine as (Besylate)……….5mg
Hydrochlorothiazide……..12.5mg
Type of Form Form 5
Approval status of product in Exforge Hct Of ( USFDA Approved)
Me-too status (with strength and Exforge Hct Of M/S Novartis Pharma
dosage form)
that overall firm has satisfactory level of GMP compliance.
Brand Name +Dosage Form + Strength Napro Plus 500mg/20mg Tablet
Naproxen USP ……….500mg
Esomeprazole USP……..20mg (Salt not mentioned)
Type of Form Form 5
Approval status of product in VIMOVO of USFDA approved
dosage form)
compliance.
Remarks of the Evaluator  Stability studies
Decision: Reistration board deferred the application for submission of Stability studies.
Moreover,Registration Board deferred the case as FID has reported for not having stability chamber
Brand Name +Dosage Form + Strength Apix 2.5mg Tablet
Apixaban USP ……….2.5mg
Pharmacological Group Antithrombotic agents
Type of Form Form 5
Finished product Specifications Manufacturer specifications
Approval status of product in ELIQUIS of ( USFDA Approved)
dosage form)
compliance.
Remarks of the Evaluator  Stability Studies
Moreover, Registration Board deferred the case as FID has reported for not having stability chamber
Brand Name +Dosage Form + Strength Apix 5mg Tablet
Apixaban USP ……….5mg
Pharmacological Group Antithrombotic agents
Type of Form Form 5
Finished product Specifications Manufacturer specifications
Approval status of product in ELIQUIS of ( USFDA Approved)
Reference Regulatory Authorities Of
dosage form)
compliance.
Brand Name +Dosage Form + Strength Atenol 100mg Tablet
Atenolol USP ……….100mg
Pharmacological Group Antihypertensive/Beta Blocker
Type of Form Form 5
Approval status of product in Tenormin 100mg of ( USFDA Approved)
Me-too status (with strength and Atenoscot Tablets 100mg of M/S Scotmann Pharmaceuticals
dosage form)
compliance.
Brand Name +Dosage Form + Strength Telsart 20mg Tablet
Telmisartan USP ……….20mg
Type of Form Form 5
Approval status of product in Micardis of ( USFDA Approved)
Me-too status (with strength and Misar 20mg Tablets of M/S Highnoon Laboratories
dosage form)
compliance.
Brand Name +Dosage Form + Strength Telsart 40mg Tablet
Type of Form Form 5
Approval status of product in Micardis of ( USFDA Approved)
Me-too status (with strength and Misar 40mg Tablets of M/S Highnoon Laboratories
dosage form)
compliance.
Brand Name +Dosage Form + Strength Vortox 5mg Tablet
Vortioxetine USP ……….5mg
Pharmacological Group (Psycho analeptic,Antidepressant)
Type of Form Form 5
Finished product Specifications Manufacturers specifications
Approval status of product in Trintellix of ( USFDA Approved)
Me-too status (with strength and Not found.
dosage form)
compliance.
Brand Name +Dosage Form + Strength Vortox 20mg Tablet
Vortioxetine USP ……….20mg
Pharmacological Group (Psycho analeptic,Antidepressant)
Type of Form Form 5
Finished product Specifications Manufacturers specifications
Approval status of product in Trintellix of ( USFDA Approved)
Me-too status (with strength and Not found.
dosage form)
Decision: Reistration board deferred the application for submission of Stability studies. Moreover,
Registration Board deferred the case as FID has reported for not having stability chamber for
conducting Real time stability studies.
Brand Name +Dosage Form + Strength Losart 50mg Tablet
Losartan Potassium USP ……….50mg
Type of Form Form 5
Approval status of product in Cozaar, 50 mg of ( USFDA Approved)
Me-too status (with strength and Jasartan Tablets 50mg of M/S Jawa Pharmaceutical
dosage form)
compliance.
Brand Name +Dosage Form + Strength Losart HCT 50mg/12.5mg Tablet
Hydrocholothiazid…………12.5mg
Pharmacological Group Antihypertensive(Angiotensin II Receptor Antagonist,
Thiazide Diuretic)
Type of Form Form 5
Approval status of product in Cozaar Comp 50 Mg/12.5 Mg of (MHRA Approved)
Me-too status (with strength and Lotass Plus 50mg/12.5mg of M/S Getz pharma
dosage form)
compliance.
Brand Name +Dosage Form + Strength Losart HCT 100mg/25mg Tablet
Hydrocholothiazid…………25mg
Thiazide Diuretic)
Type of Form Form 5
Approval status of product in Cozaar Comp 100 Mg/25 Mg of ( MHRA Approved)
Me-too status (with strength and Lotass Plus 100mg/25mg of M/S Getz pharma
dosage form)
compliance.
Brand Name +Dosage Form + Strength Liskopride 25mg Tablet
Levosulpirid……….25 mg
Type of Form Form 5
Approval status of product in LEVOPRAID 25 mg tablet of AIFA italy
Me-too status (with strength and Scipride tabletM/s Getz Pharma
dosage form)
compliance.
Decision: : Registration Board deferred the case as FID has reported for not having stability chamber
Brand Name +Dosage Form + Strength Telsart HCT 80mg/25mg Tablet
Hydrochlorothiazid……..25mg
Thiazide Diuretic)
Type of Form Form 5
Pack size & Demanded Price 10’s, 14’s, ; As per SRO
Approval status of product in Micardis HCT of ( USFDA Approved)
Me-too status (with strength and Teli-H Tabletsof M/S Wilson’s Pharmaceuticals
dosage form)
Remarks of the Evaluator  Evidence of double compression machine not found.
Decision: Registration board deferred the case for Evidence of double compression Machine verified by
FID. Moreover, Registration Board deferred the case as FID has reported for not having stability
chamber for conducting Real time stability studies.
531. Name and address of manufacturer / M/S Aspin Pharma (Pvt) Ltd., Plot No. 10 & 25. Sector 20, Korangi
Brand Name +Dosage Form + Strength Denfos 10mg Tablet
Alendronate Sodium Trihydrate 13.05mg Eq to Alendronic acid
…………10mg
Pharmacological Group Bisphosphonate ( Antiosteoporotic)
Type of Form Form 5
Approval status of product in Alendronic Acid 10mg of MHRA approved
Me-too status (with strength and Bonafide Tablets 10mg by M/s Medisure Labs.
dosage form)
GMP status The last GMP inspection conducted on 02-02-2018 and report
concludes that firm was considered to be operating at satisfactory
Remarks of the Evaluator  Firm change from film coating to uncoated tablet.
b. Deferred cases
i. Human
Evaluator PEC-XIV
Sr. Name and Brand Name Type of Form Approval status Previous Evaluation by
No address of (Proprietary Initial date, in Reference Decisions PEC
manufacturer name + Dosage diary regulatory
/ Applicant Form + Fee including agencies /
Strength) differential fee authorities
Composition Demanded Me-too status/
Pharmacologic Price /Pack GMP status
al Group size
Finished
product
Specification
532. M/s Shaigan Ruwin 200mg Form 5 Spanish Agency Deferred for Approval status
Pharmaceutic Capsules 27-03-2015 of Medicines and evidence of in Spanish
als (Pvt) Ltd, Each capsule Dy.No.1973 Health Products approval by medicine
Rawalpindi contains:- Rs.8000/= reference agency has
Cefixime as + Rs.12,000/= Suprax by regulatory been
Trihydrate…… 25-03-2015 Lupin authorities confirmed.
200mg 1x5’s Pharma as stated
(Cephalosporin Icef Capsule by reference is
Rs. 185
Antibiotic) ICI incorrect.
USP Specs (M-266)
Last GMP
inspection was
conducted on 14-
12-2017 and the
report concludes
issuance of GMP
certificate for export
purpose.
Decision: Approved.
533. M/s Noa Tablet Flexibon Form 5 Arthrotec 50 Deferred for The firm has
Hemis Rs. 20,000/- vide modified release completion of submitted
Pharmaceutica Each tablet Dy. No. 168 tablets of Pfizer application w.r.t complete
ls, Plot # 154, contains (MHRA) following master
dated 17-09-
Sector 23, Diclofenac shortcomings(M formulation
Korangi Sodium(enteric 2011 & 10-04- Cytopan 50 of -256):- stating enteric
Industrial coated)…..50mg 2014 M/s GETZ coated
Area, Misoprostol 20’s Rs. 350/- (Reg#039729) To furnish Diclofenac
Karachi ……. 200 mcg approval status sodium and
of same dosage Misoprostol
NSAID/ GMP inspection form in (1% dispersion
Prostaglandin dated 20-03-2018 reference w/w in HPMC).
is considered to regulatory
In house be operating at an authorities.
specifications acceptable level
of compliance. To submit
complete
dosage form
along with
quantities of
salt and base in
master
formulation
per unit dose
and per batch.
To furnish
master
formulation
with amount of
base as well as
salt per unit
dose and per
batch.
Official
monographs/
reference
pharmacopeia
required for
active aninactive
ingredient in
the
masterformulati
on.
Reference of
finished
product
specification
alongwith
procedure of
analysis.
Decision: Deferred for the clarification of manufacturing outline as in reference regulatory authorities.
534. M/s Semos Semorfen Ds Form-5 Ibuprofen 200 mg/ Deferred for The approval
Pharmaceutica Suspension Fast Track 5ml oral suspension Product specific status of
ls (Pvt.) Ltd. Each 5ml Unit carton, by M/s Aspire inspection by applied
Plot No. 11, contains…….. Pet bottle and Pharma Ltd, MHRA Director, DTL formulation has
Sector 12-A Ibuprofen…… packed in a approved Karachi and been confirmed
North Karachi, …… 200mg cardboard Area FID in MHRA.
Karachi Anti-rheumatic carton; As per Brufen DS (M-241).
PAC 200mg/5ml
15-05- Suspension by M/s
2013/951 Abbott
Rs.60,000/- (Reg#070851)
Routine GMP
inspection
conducted on 17-
10-2017 showed
that current level of
compliance is rated
as good.
535. M/s. Welmark Esocon 40mg Form 5 Nexium 40mg Deferred for ● The
Pharmaceuticals, Tablets 11-10-2010 tablet of MHRA evidence of firm has
Hattar Each tablet Dy No. 24 approved. approval of submitted
contains:- Rs.8000/ applied revised Form-5
Esomeprazole… Rs.12,000/- Esoproto by formulation by with following
……40mg 31-10-2014 Wilshire Pharma reference label claim
2x7’s regulatory ● Each
(Proton Pump As Per SRO Last inspection authorities.(M- Enteric coated
Inhibitor) report.12-7-2017, 265) tablet contains:
overall cGMP Internationally Esomeprazole
USP was satisfactory available as (as magnesium
Specification as per Drap enteric coated trihydrate)……
Guidelines. tablet with ……40mg.
magnesium salt. ● The
Deferred for firm has
submission of submitted fee
fee for revision challan of Rs.
of formulation. 20,000/-
(M-281) (Deposit
slip#0725743)
dated 11-06-
2018.
Decision: Approved.
536. M/s AGP Cinpride 1mg Form-5 Spanish Agency Deferred for The firm has
(Private) Tablet Dy. No: 507 of Medicines and confirmation of submitted fee
Limited, B-23 Each film dated. Health Products approval status challan of Rs.
SITE Area coated tablet 15.11.2011 by Reference 20,000/-
Cinita Tablet 1mg
Karachi contains: Rs.8,000/- regulatory (Deposit
of Novamed
Cinitapride authorities. slip#0614245)
02.08.2013 Pharma
hydrogen (M-257) Dated 02-04-
Rs.12,000/- (Reg#064845)
tartarate eq 2018.
to cinitapride Rs.255/10’s Deferred for
Inspection dated
…. 1mg submission of fee
18-9-2017
(antiemetic) as the firm has
concluded that
(Mfg. Specs) revise the
overall
formulation.
compliance was
(M-277)
good.
537. M/s Saydon Depam Inj Form 5 Diazepam Deferred for Approval status
Pharmaceutica 5mg/ml 17-01-2011 Injection of approval by has been
l Industries Rs. 8,000/- Hospira reference confirmed in
(Pvt) Ltd. 77- Each 2ml 07-01-2015 (USFDA) regulatory MHRA.
A Hayatabad ampoule Rs. 12,000/- authorities.
Industrial contains:- As Per SRO Relaxipam (M-251)
Estate Diazepam Injection of Epla
Peshawar. ….…10mg (Reg#003368)
Liquid (Benzodiazepine) Last GMP
Injection (B.P) inspection
(Psychotropic) conducted on 13-
Section 02-2018
No. F.2-5/94- concluding
Lic (Vol. II) acceptable level
dated 24-01- of compliance
2011) with GMP
guidelines.
Decision: Approved.
538. M/ s Rotex Tracer 100mg Form 5 Sporanox Deferred for The firm has
Pharma, Capsules 11-04-2011 Capsule source of submitted
Islamabad Each capsule By Johnson and pellets, along Source of
contains:- Dy No. Johnson with stability Pellets: M/s
Itraconazole (as 2344 USFDA studies data, Vision
Pellets 22%)…. Rs.8000/= Rolac Capsule GMP certificate Pharmaceutical
100mg Rs.12,000/= By M/s Sami. of supplier and
s, GMP
(Antifungal, 08-12-2014 Icon by differential fee
Systemic) 4’s in case of import certificate and
Ferozsons stability studies
Manufacturer As Per PRC of pellets. (M-
Specs. GMP 30-03- 279) data of 3
2017 grant of batches.
additional
sections
539. M/s Amaan Kamelone-200 Form 5 USFDA Registration The firm has
Pharma 30km, Injection 19976 approved Board deferred undertaken that
Sheikhupura Each ml contains: 01.06.2018, in 266th meeting our product
Deca-durabolin
Road Lahore. Nandrolone 31.05.2018, for evidence of Kamelone-
Injection (OBS
Decanoate Rs.5000/-, approval by 25mg injection,
Pharma)
(USP)….200mg 02-06-2018 reference deferred in
Anabolic Steroid Rs.15,000/-, GMP inspection regulatory 266th meeting
(USP) 1×1ml conducted on 11- authorities. may please be
ampoule; As 05-2018 withdrawn and
per SRO concluded that in place we
overall request for
manufacturing addition of
facility, Kamelone -
equipment/ 200mg
instruments and injection for
hygienic registration.
condition of the
firm was good. Me-too status
However, they not confirmed.
are needed
improvements in
documentation
related to
production and
Quality control.
Firm showed
good intention to
improve further.
Firm has provided copy of letter issued by Secretary CLB, dated 02-03-2015, stating the approval for grant of DML
by way of formulation for following sections:
Liquid Injectable Ampoule (General)
Liquid Injectable Ampoule (Hormone)
Liquid Injectable Ampoule (Steroid)
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic / me-too
540. Name and address of manufacturer / M/s Arsons Pharmaceutical Industries, Lahore.
Applicant
Brand Name +Dosage Form + Strength Metrozole-DS tablets 400mg
Metronidazole….…..400mg
Diary No. Date of R& I & fee Dy. No.2513; 21-6-2011; Rs.8,000/- (20-6-2011); Rs.12,000/- (06-
1-2015)
Pharmacological Group Anti-amoebic
Type of Form Form-5
Finished product Specification Manufacturer Specification’s
Pack size & Demanded Price 10x10’s; As per Govt
Approval status of product in Reference Flagyl of Winthrop Pharma, UK (MHRA)
Me-too status Ektal by Gaba Pharma (Reg No : 055522)
GMP status Last Inspection report 30-1-2017 and 22-03-2017
The panel recommended the grant of additional section
Previous remarks of the Evaluator.  Firm claimed Manufacturer Specification, while the product is
present in BP pharmacopeia
Previous decision(s) Deferred for submission of GMP inspection report conducted
within a period of 1 year (M-272).
Evaluation by PEC Based on inspection conducted on 02-01-2018, it is concluded that
on the day of inspection the firm has satisfactory compliance of
GMP.
541. Name and address of manufacturer / M/s Arsons Pharmaceutical Industries, Lahore
Applicant
Brand Name+Dosage Form + Strength Ridal Tablets 2mg
Risperidone…..2mg
Diary No. Date of R& I & fee Dy.No.3569; 16-3-2011; Rs.12,000/- (6-2-2015); Rs.8,000/- (16-3-
2011)
Pharmacological Group Benzisoxazole Derivative
Type of Form Form-5
Me-too status Risperidone 2mg (Reg No. 053561) by Genome
Previous remarks of the Evaluator. Firm has claimed Manufacturer specifications but the applied
formulation exist in USP.
Previous decision(s) Deferred for submission of GMP inspection report conducted
within a period of 1 year and clarification of pharmacological group
(M-272)
GMP.
The firm has submitted pharmacological group as “Atypical
Antipsychotic”.
Applicant
Brand Name+Dosage Form + Strength Arpride Tablet 50mg
rd
219
Itopride……50mg
3-2011)
Type of Form Form-5
Approval status of product in Reference PMDA, Japan
Me-too status Ganaton Tablet (Reg No. 028429) by M/s Abbott Laboratories
Previous remarks of the Evaluator. Reference product is available as film coated tablet whereas
Arpride is plain tablet.
Previous decision(s) Deferred for following reasons:
Confirmation of dosage form whether coated or uncoated and
submit manufacturing outline accordingly.
Submission of latest GMP inspection report conducted within 1
year(M-272).
GMP.
The firm has submitted revised Form-5 for film coated tablet along
with fee challan of Rs. 5000/- (Deposit slip # 0738111) dated 25-
05-2018.
Applicant
Brand Name+Dosage Form + Strength Arythrocin 500mg tablet
Erythromycin As stearate….500mg
6-2011)
Pharmacological Group Macrolide
Type of Form Form-5
Me-too status Acumen by Rakaposhi Pharma
Previous remarks of the Evaluator. Reference product is available as film coated tablet whereas firm
has applied as plain tablet.
Firm claimed Manufacturer Specification, while the product is
year(M-272).
GMP.
05-2018.
Decision: Approved with international pharmacopoeia specification.
Applicant
Brand Name+Dosage Form + Strength Arythrocin 250mg tablet
Erythromycin As stearate….250mg
6-2011)
Type of Form Form-5
Me-too status Acumen by Rakaposhi Pharma
Previous remarks of the Evaluator. Reference product is available as film coated tablet whereas firm
has applied as plain tablet.
Firm claimed Manufacturer Specification, while the product is
year(M-272).
GMP.
05-2018.
Decision: Approved with international pharmacopoeia specification.
Applicant
Brand Name+Dosage Form + Strength Claritine 5mg tablet
Composition 16-03-11 Dy. No. 325/R&I Rs.8000/- Rs.12000/= 16.01.2015
Diary No. Date of R& I & fee Each film coated tablet contains:
Levocitirizine dihydrochloride …5mg
Pharmacological Group Histamine H1 blocker(antiallergic)
Type of Form Form 5
Finished product Specification BP specs
As per SRO
Approval status of product in Reference
Levocetirizine by Teva Pharmas (USFDA)
Me-too status Frisk by Webros, Islamabad (R. No. 060835)
Previous remarks of the Evaluator.
Previous decision(s) Deferred for submission of latest GMP inspection report conducted
within 1 year(M-272).
GMP.
Decision: Approved.
Applicant
Brand Name+Dosage Form + Strength Norilet 400mg tablet
Norfloxacin….…400mg
Diary No. Date of R& I & fee 16-03-11 Dy. No. 325/R&I Rs.8000/- Rs.12000/= 16.01.2015
Pharmacological Group Flouroquinolone antibiotic
Type of Form Form 5
Finished product Specification USP specs
As per SRO
Approval status of product in Reference Nolicin by Novartis pharma
Me-too status Qucaine by Hassan Pharma Reg No. 041755
The panel recommended the grant of additional section.
within 1 year (M-272).
GMP.
Decision: Approved.
Applicant
Brand Name+Dosage Form + Strength Agril 75mg tablet
Clopidogrel as bisulfate ……………75mg
Diary No. Date of R& I & fee 16-03-11 Dy. No. 325/R&I Rs.8000/-
Rs.12000/- 16.01.2015
Pharmacological Group Platelet inhibitor
Type of Form Form-5
Approval status of product in Reference Plavix tablets by Sanofi
Me-too status Plavix tablets by Sanofi Aventis
The panel recommended the grant of additional section.
within 1 year(M-272).
GMP.
Decision: Approved.
548. Name and address of manufacturer / M/s. Panacea Pharmaceuticals, Plot no.4, Street no. S-6, National
Applicant Industrial Zone, Rawat, Islamabad.
Brand Name+Dosage Form + Strength Lite 600mg Tablets
Linezolid ………….……...600mg
Pharmacological Group Oxazolidinone , Antibiotics
Type of Form Form-5
Pack size & Demanded Price As per SRO & as recommended by the PRC (MOH)
Approval status of product in Reference Zyvox of M/s Pharmacia, Ramsgate Road, Sandwich , Kent (UK)/
Regulatory Authorities. Zyvox by Pharmacia (USFDA Approved)
Me-too status Nezocin of M/s Brookes Pharmaceuticals/ Volinza by Wilshire
GMP status Last GMP inspection was conducted on 08-12-2016 which
concludes good level of GMP compliance. Minor observations as
advised were asked to be removed at the earliest.
Previous decision(s) Registration Board referred the case to QA & LT Division to
conduct GMP inspection of Firm on priority (M-277).
the firm is complying cGMP as of today. However, compliance of
the observations is advised to be submitted along with an action
plan at an earliest.
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.
Brand Name+Dosage Form + Strength Lite Dry suspension 100mg/5ml
Composition After reconstitution each 5ml contains:
Linezolid ……………………….100mg
Pharmacological Group Antibacterial Agent Of Oxazolidinone Class
Type of Form Form-5
Approval status of product in Reference Zyvox of M/s Pharmacia limited (UK)
Me-too status Nezocin of M/s Brookes Pharmaceuticals
Brand Name+Dosage Form + Strength Pain-Go 8mg Tablet
Lornoxicam………………..8mg
Pharmacological Group Oxicams
Type of Form Form-5
rd
223
Approval status of product in Reference Xefo, ANSM, France Approved
Me-too status Xoni-fast by M/s Macter International
Brand Name +Dosage Form + Strength Tromser-P Tablets 37.5/325mg
Tramadol HCl………….……..37.5mg
Acetaminophen ………………325mg
Pharmacological Group NSAIDs, Opioid Analgesic
Type of Form Form-5
Finished product Specification U.S.P.
Approval status of product in Reference Ultracet of M/s Janssen Pharmaceuticals (USA)
Me-too status Distalgesic of M/s Atco Pharmaceuticals
Brand Name+Dosage Form + Strength Valopine Plus Tablet 5/160mg
Amlodipine Besylate eq.to Amlodipine ………….…5mg
Valsartan…………………160mg
Type of Form Form-5
Approval status of product in Reference Exforge of M/s Novartis Pharmaceuticals (UK) MHRA Approved
Me-too status Exforge of M/s Novartis Pharmaceuticals (Pak)
Brand Name+Dosage Form + Strength Valopine Plus Tablet 10/160mg
Amlodipine Besylate eq.to Amlodipine ………10mg
Valsartan…………………160mg
Type of Form Form-5
Approval status of product in Reference Exforge of M/s Novartis Pharmaceuticals (UK)/MHRA Approved
Me-too status Exforge of M/s Novartis Pharmaceuticals (Pak)
Brand Name+Dosage Form + Strength Qutec XR Tablets 300mg
Composition Each Extended-Release tablet contains:
Quetiapine as Fumarate eq.to Quetiapine ………300mg
Pharmacological Group Atypical antipsychotic
Type of Form Form-5
Approval status of product in Reference Seroquel of M/s Astra Zeneca (Belgium)
Me-too status Evokalm of M/s Pharm Evo Pharmaceuticals
Brand Name+Dosage Form + Strength Qutec 25mg Tablets
Quetiapine as Fumarate eq.to Quetiapine ………….……...25mg
Pharmacological Group A typical antipsychotic
Type of Form Form-5
Approval status of product in Reference Seroquel of M/s Astra Zeneca (Belgium)/ Quetiapine Fumarate 25
Regulatory Authorities. mg film-coated tablet by M/s Teva (USFDA)
Me-too status Evokalm 25 mg film-coated tablet of M/s Pharm Evo
Pharmaceuticals
Brand Name+Dosage Form + Strength Sitamet Tablets 50/500mg
Sitagliptin Phosphate Monohydrate eq.to
Sitagliptin…………………50mg
Metformin HCl…………..500mg
Pharmacological Group Hypoglycemic agents
Type of Form Form-5
Pack size & Demanded Price As per SRO& as recommended by the PRC (MOH)
Approval status of product in Reference Janumet of M/s Merck Sharp & Dohme (UK)/USFDA Approved
Me-too status Treviamet tablet 50/500mg of M/s Getz Pharmaceuticals
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
Finished product Specification Manufacturer’s Specification
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 for evidence of approval in reference regulatory
authorities. (M-273)
Deferred for submission of fee for revision of applied
formulation.(M-281)
Evaluation by PEC  The firm has submitted revised Form-5 with following label
claim
 Each Enteric coated tablet contains:
Esomeprazole (as magnesium trihydrate)……20mg.
 The firm has submitted fee challan of Rs. 20,000/- (Deposit
slip#0725742) dated 11-06-2018.
558. Name and address of manufacturer / M/s. Welmark Pharmaceuticals, Plot No. 122, Block B, Phase V,
Applicant Industrial Estate, Hattar,
Brand Name+Dosage Form + Strength Flopine Capsule
Olanzapine………12 mg
Fluoxetine…………25 mg
Pharmacological Group Typical antipsychotic, SSRI
Type of Form Form-5
Me-too status Olanzo-F by Regal
GMP status Last inspection report.12-7-2017 Overall cGMP was satisfactory as
per Drap Guidelines.
Previous remarks of the Evaluator.  The salt of active ingredient Fluoxetine is not mentioned
on Form 5.
Warnings: Suicidal Thoughts And Behaviors; And Increased
Mortality In Elderly Patients With Dementia-Related Psychosis
Previous decision(s) Deferred for the clarification as the applied formulation is approved
in reference regulatory authority as “Fluoxetine hydrochloride”
while you have applied for “fluoxetine” (M-274).
Deferred for further deliberation regarding requirement of fee for
change of formulation(M-279).
Evaluation by PEC The firm has submitted revised Form-5 along with fee challan of
Rs. 5000/- (Deposit slip # 0757824) dated 31-05-2018 stating
correct salt form as follows:
Each capsule contains:
Olanzapine…………………12 mg
Fluoxetine as HCl………..……25 mg
Decision: Approved.
559. Name and address of manufacturer / M/s Shrooq Pharmaceuticals (Pvt.) Ltd., 21-Km, Feroz Pur Road,
Applicant Lahore.
Brand Name+Dosage Form + Strength Sugrel Tablets
Composition Each Film Coated Tablet contains:-
Prasugrel as hydrochloride…….5mg
Diary No. Date of R& I & fee Duplicate, 03-03-2010, 8,000/-, (Photocopy attached), 24-02-2010,
12,000/- (Photocopy attached), 22-05-2013
Pharmacological Group Platelet aggregation inhibitor
Type of Form Form-5
Finished product Specification In-house specification
Pack size & Demanded Price 10’s; Rs.1275/- 20’s; Rs. 2550/-
Me-too status Eficlot Tablet 5mg of CCL Pharma (Reg#067765)
GMP status Inspection dated 30-08-2017 recommended for Renewal of DML.
Previous decision(s) Approved. However, the Board advised to submit new complete
and signed form 5. (M-239)
Evaluation by PEC The firm has submitted new complete and signed Form-5.
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.
560. Name and address of manufacturer / M/s Shrooq Pharmaceuticals (Pvt.) Ltd., 21-Km, Feroz Pur
Applicant Road, Lahore.
Brand Name +Dosage Form + Strength Medison Cream
Composition Each 5gram contains:-
Mometasone Furoate………0.1%
Type of Form Form-5
Pack size & Demanded Price 5g, 15g packed in Aluminum tube; N/A
Approval status of product in Reference Elocon cream of MSD (USFDA Approved)
Me-too status Hivate cream of Saffron Pharma (Reg#046432)
Previous decision(s) Deferred till decision of semisolid steroidal products in semisolid
general section by licensing section and submission of raw material
specifications.(M-239)
Evaluation by PEC The firm has submitted raw material specifications.
Decision: Approved with USP specification. 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 Lite Orange Sachet
Composition Each sachet contains:-
Sodium citrate…………..2.9g
Sodium Chloride………..2.6g
Potassium chloride……….1.5g
Anhydrous Glucose…..…….13.5g
Type of Form Form-5
Finished product Specification International Pharmacopoeia
Pack size & Demanded Price 10’s; N/A
Approval status of product in Reference New formulation of Oral Rehydration Salts (ORS) with reduced
Regulatory Authorities. osmolarity (WHO approved)
Me-too status Orsol Sachet ORS by M/s Kaizen Pharmaceuticals (Reg#073897)
Previous decision(s) Deferred for clarification of master formula and change of inactive
ingredients according to FDA limits. (M-239)
Evaluation by PEC The firm has submitted revised Form-5 with correct master
Formula and quantity of inactive ingredient was
Orange Flavor……….0.05gm and maximum potency per unit dose
defined by FDA is 50mg per Packet.
However, fee has not been submitted.
562. Name
* and address of manufacturer / M/s Shrooq Pharmaceuticals (Pvt.) Ltd., 21-Km, Feroz Pur Road,
Applicant Lahore.
Brand Name +Dosage Form + Strength Rivacet 1mg Tablets
Entecavir (as Monohydrate)………….1mg
Diary No. Date of R& I & fee Duplicate, 28-06-2010, 8000/-, 16-06-2010, 12,000/- (Photocopy
attached), 21-05-2013
Pharmacological Group Anti-viral, Anti-cytomegalovirus
Type of Form Form-5
Approval status of product in Reference Baraclude-MHRA
Me-too status Obee by Genome pharma
Previous decision(s) Deferred for product specific inspection by Director Drug Testing
Laboratory Lahore and area FID and replacement of methylene
chloride. (M-238)
Evaluation by PEC The firm has revised coating composition without methylene
chloride.
563. Name
* and address of manufacturer / M/s Shrooq Pharmaceuticals (Pvt.) Ltd., 21-Km, Feroz Pur Road,
Applicant Lahore.
Brand Name +Dosage Form + Strength Rivacet 0.5mg Tablets
Entecavir (as Monohydrate)………….0.5mg
Diary No. Date of R& I & fee Duplicate, 28-06-2010, 8000/-, 16-06-2010, (Photocopy attached),
Pharmacological Group Anti-viral, Anti-cytomegalovirus
Type of Form Form-5
Approval status of product in Reference Baraclude tablets by Bristol Myers
Me-too status Livose-C tablets by Wilson
Previous decision(s) Deferred for product specific inspection by Director Drug Testing
Laboratory Lahore and area FID and replacement of methylene
chloride. (M-238)
Evaluation by PEC The firm has revised coating composition without methylene
chloride.
Applicant Lahore.
Brand Name +Dosage Form + Strength Duaba Sachet
Composition Each Sachet contains:
Strontium Ranelate…………..2.00g
Pharmacological Group Bone modulating Drug
Type of Form Form-5
Pack size & Demanded Price 7’s, 10’s; N/A
Approval status of product in Reference Strontium ranelate Aristo 2 g granules for oral suspension (MHRA
Me-too status Orelate oF Wns Field Pharmaceuticals
Previous decision(s) Deferred for clarification of master formula and change of inactive
ingredients according to FDA limits. (M-239)
Evaluation by PEC The firm has submitted Form-5 with quantities of inactive
ingredients as mentioned in master formulation whereas maximum
potency per unit dose mentioned in FDA was as follows:
Inactive Formulation FDA Limits
Ingredients quantities
Maltodextrin 600mg 729mg
Mannitol 1000mg 1100mg
Aspartame 400mg 450mg
letter.
565. Name and address of manufacturer / M/s Lahore Chemical and Pharmaceutical Works (Pvt.) Ltd., 137-
Applicant Ferozepur Road Lahore.
Brand Name +Dosage Form + Strength Esta Tablet 10mg
Escitalopram as oxalate…..10mg
Pharmacological Group SSRIs
Type of Form Form-5
Pack size & Demanded Price 10’s; Rs.250
Approval status of product in Reference Escitalopram Tablets 10mg of Teva Pharma USFDA
Me-too status Citanew Tablet 10mg of M/s Hilton Pharmaceuticals, (Reg.#
036426)
GMP status Panel inspection dated 12-04-2017 and 17-05-2017 concluded that
the firm had rectified the shortcomings pointed out by Mr.
Muhammad Jamil, Provincial drug inspector and directed the firm
to submit compliance report in tabulated form within one-month
time period for the observations pointed out by the panel of experts
in the inspection.
Previous remarks of the Evaluator. Approved in USFDA with boxed warning of suicidality.
Following documents are still missing in application dossier:
 Evidence of section approval granted by CLB.
 Commitments of 251st meeting.
 Undertaking to conduct stability studies.
 Product specific manufacturing method.
Previous decision(s) Deferred for submission of following documents: (M-272)
Evaluation by PEC  The firm has submitted commitments as per 251st meeting.
 The firm has submitted document from licensing division for
Approval of Revised Layout Plan for Amendments / Expansion
under DML No. 000064 dated 25-09-2017.
 The firm has submitted compliance report to address the
observations reported by the panel.
Decision: Approved.
Brand Name +Dosage Form + Strength Esotone 40mg Capsule
Enteric coated pellets of Esomeprazole as magnesium trihydrate
……40mg
Type of Form Form-5
Pack size & Demanded Price 2x7’s; Rs.250
Approval status of product in ReferenceEsomperazole magnesium Capsule 40mg of Mylan
Regulatory Authorities. Pharmaceuticals USFDA
Me-too status Esomax Capsule 40mg of M/s Martin Dow Pharmaceuticals
in the inspection.
Previous remarks of the Evaluator.  Source of pellets: Vision Pharma
 Following documents are still missing in application dossier:
 Incorrect dosage form on Form 5.
 Correct dosage form on Form-5.
Decision: Deferred for submission of latest GMP inspection report conducted within period of one year.
Brand Name +Dosage Form + Strength Esotone 20mg Capsule
Enteric coated pellets of Esomeprazole as magnesium trihydrate
……20mg
Type of Form Form-5
Pack size & Demanded Price 2x7’s; Rs.170
Approval status of product in Reference Esomperazole magnesium Capsule 20mg of Mylan
Regulatory Authorities. Pharmaceuticals USFDA
Me-too status Esomax Capsule 20mg of M/s Martin Dow Pharmaceuticals
in the inspection.
Previous remarks of the Evaluator.  Source of pellets: Vision Pharma
 Following documents are still missing in application dossier:
 Incorrect dosage form on Form 5.
 Correct dosage form on Form-5.
Brand Name +Dosage Form + Strength Pulmikast Tablet 10mg
Montelukast as sodium …..10mg
Pharmacological Group Leukotriene antagonist
Type of Form Form-5
Approval status of product in Reference Montelukast film coated tablets 10mg of Apotex Corp. USFDA
Me-too status Montika 10mg film coated tablet of M/s Sami Pharmaceuticals
in the inspection.
Previous remarks of the Evaluator. Following documents are still missing in application dossier:
Brand Name +Dosage Form + Strength Pulmikast Tablet 5mg
Composition Each chewable tablet contains:-
Montelukast as sodium …..5mg
Pharmacological Group Leukotriene antagonist
Type of Form Form-5
Approval status of product in Reference Montelukast Chewable tablets 5mg of Apotex Corp. USFDA
Me-too status Amisped 5mg chewable tablet of M/s Sami Pharmaceuticals
in the inspection.
Previous remarks of the Evaluator. Following documents are still missing in application dossier:
570. Name and address of manufacturer / M/s Welwrd Pharmaceuticals plot#3 Block A, phase-I-II, Industrial
Applicant Estate, Hattar KPK.
Brand Name +Dosage Form + Strength Paroxiwel CR 25mg Tablets
Paroxetine as hydrochloride…..25mg
Pharmacological Group Anti-psychotic
Type of Form Form-5
Approval status of product in Reference Paxil CR 25mg film coated-extended release tablet of Apotex Corp.
Me-too status Myroxit CR tablet 25mg of M/s WelMark Pharmaceuticals
(Reg#078598)
GMP status Last inspection conducted on 14-06-2017 and report concludes that
overall the firm is GMP compliant.
Previous remarks of the Evaluator. Firm has not provided following:
 Approval of section/manufacturing facility.
 Undertaking that the contents mentioned in the dossier are
correct.
Innovator brand Paxil CR tablet:
Approved with boxed warning of suicidality.
Each enteric, film-coated, controlled-release tablet contains
paroxetine hydrochloride equivalent to paroxetine as follows: 12.5
mg–yellow, 25 mg–pink, 37.5 mg–blue. One layer of the tablet
consists of a degradable barrier layer and the other contains the
active material in a hydrophilic matrix.
Previous decision(s) Deferred for following reasons:(M-272)
Clarification of applied formulation as per approval of innovator’s
formulation
Evidence of approval of section/manufacturing facility and
Submission of undertaking that the contents mentioned in the
dossier are correct.
Evaluation by PEC The firm has submitted revised master formulation and label claim
as per innovator as below:
Each Enteric Film coated Controlled Release tablet contains:
Paroxetine as HCl……………….25mg
The firm has submitted commercial invoice of Rotary Tablet Press
ZP-33
The firm has provided Tablet (General) section.
The firm has submitted undertaking.
Decision: Deferred for submission of fee for revision of applied formulation.
571. Name and address of manufacturer / M/s Lisko Pakistan (Pvt) Ltd., L-10-D Block-21, Shaheed Rashid
Applicant Minhas Road, F.B. Industrial Area Karachi
Brand Name +Dosage Form + Strength Fenolis 100mg Capsule
Fenofibrate …………..100mg
Pharmacological Group Fibric acid (Antihyperlipidemic)
Type of Form Form 5
Pack size & Demanded Price 30’s: Rs. 15/capsule
Approval status of product in Reference Lipidil capsule by Abbvie
GMP status Last inspection report dated 24-04-2018 confirms good
compliance to GMP.
Previous remarks of the Evaluator. Firm was asked to provide evidence of me-too status, in response
to the query the firm has requested to change the formulation to the
following, since the me-too of 100mg is not available
Each capsule contains
Fenofibrate (Micronized)……200mg
200mg capsule is approved by MHRA and its me-too is also
available.
Previous decision(s) Deferred for submission of fee PKR 20,000/- since the firm has
requested to change the formulation from Capsule containing
100mg fenofibrate to capsule containing 200mg fenofibrate.(M-
273)
Evaluation by PEC The firm has submitted fee challan of Rs. 20,000/- (Deposit slip #
0545434) dated 07-12-2017 for revision of applied formulation
from capsule 100mg to capsule 200mg.
Fenogal 200mg Capsule of Searle Pakistan (Reg#024095).
572. Name and address of manufacturer / M/s Platinum Pharmaceuticals (Pvt) limited, A-20 North Western
Applicant Industrial Zone, Karachi
Brand Name +Dosage Form + Strength Salbeclo CFC Free Inhaler
Composition Each metered inhalationcontains:
Salbutamol (micronised)………………...100mcg
Beclomethasone Dipropionate……………50mcg
Pharmacological Group Corticosteroid, Bronchodilator, Antiasthmatic
Type of Form Form-5
Finished product Specification Manufacturers
Pack size & Demanded Price 200 metered actuations & as per PRC
Approval status of product in Reference Butosol Inhaler of M/s Aldo Union (Approved in Spain)
Me-too status Xaltide HFA of M/s Getz Pharma
concludes:
“The overall GMP compliance of the firm is found at an
“acceptable” level of GMP compliance. 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 GMP compliance.
Previous remarks of the Evaluator.  Firm has submitted section approval letter.
 Salt is not completely mentioned on form 5 as sulphate.
Previous decision(s) Deferred for submission of complete salt form of Salbutamol as per
reference product.(M-279)
Evaluation by PEC The firm has submitted revised Form-5 along with fee challan of
Rs. 5,000/- (Deposit slip # 0707709) dated 18-05-2018 with correct
salt form of salbutamol as follows:
Each metered inhalationcontains:
Salbutamol (as sulphate)………………...100mcg
Beclomethasone Dipropionate……………50mcg
Decision: Approved.
573. Name and address of manufacturer / M/s. Rogen Pharmaceuticals, Plot No. 30, S-4,National Industrial
Applicant Zone, Rawat, Islamabad
Brand Name +Dosage Form + Strength Metagen Cream 0.1%
Mometasone furoate……………….1mg
Pharmacological Group corticosteroid
Type of Form Form-5
Me-too status Hivate cream by Saffron
GMP status 10-04-2017, “Good”
Renewal of DML is due.
Previous remarks of the Evaluator. It is a corticosteroid.
Previous decision(s) Deferred for clarification of pharmacological group. (M-274)
Evaluation by PEC The firm has submitted that Mometasone is a medium-potency
synthetic corticosteroid with anti-inflammatory, antipruritic and
vasoconstrictive properties.
574. Name and address of manufacturer / M/s Rotex pharma, Islamabad
Applicant
Brand Name +Dosage Form + Strength Exermet 1000mg Tablet
Composition 83, 22-1-2011, Rs 8000, Rs 12,000
rd
236
Diary No. Date of R& I & fee Each film coated tablet contains:
Vildagliptin…..50mg
Metformin HCL….1000mg
Pharmacological Group Di-peptidyl peptidase-4 inhibitor
Type of Form Form-5
Finished product Specification Manufacturer’s Specifications
Approval status of product in Reference Eucreas 50 mg/1000 mg of Novartis Pharma, UK (EMC)
Me-too status Galvus Met by Novartis Pharma, Pakistan
GMP status Last Inspection report 17-3-2017

The panel concluded that the company is following GMP guidelines
Previous remarks of the Evaluator.  Fee challan photocopy is attached.
 The firm has claimed manufacturer’s specifications and has
not submitted the data as per requirement of the decision
made in 267th meeting of DRB.
Previous decision(s) Deferred for the confirmation of container closure system of
applied formulation (M-270).
Deferred for confirmation of submission of remaining fee(M-277).
Evaluation by PEC The firm has confirmed that there container closure system will be
as per innovator PA/Al/PVC/Al polyamide aluminium foil
polyvinyl chloride aluminium foil.
The firm has submitted photocopy of fee challan of Rs. 12000/-
(Deposit slip#0132129) dated 08-12-2014.
575. Name and address of manufacturer / M/s Barrett Hodgson Pakistan (Pvt) Ltd.
Applicant
Brand Name +Dosage Form + Strength Solubar capsules 0.2mg
Tamsulosin hydrochloride………..…0.2mg
(as modified release pellets)
Source of pellets: RA Chem, India.
Diary No. Date of R& I & fee Dy No.257; 12-09-2014; Rs.20,000/-,Rs.80,000/- (18thAugust
2014, 28th April 2017)
Pharmacological Group Anti- adrenergic
Type of Form Form-5
Finished product Specification As per Innovator’s specification
Pack size & Demanded Price 10’s, 20’s; Rs.300/-, Rs.600/-
Approval status of product in Reference Approved in USFDA and PMDA (as provided by the firm)
Me-too status Maxflow capsule of CCL (as provided by the firm)
GMP status Panel Inspection of M/s Barrett Hodgson conducted on 18-21
January & 2ndFebruary, 2016 recommends renewal of DML.
Previous remarks of the Evaluator. i. Firm has claimed Innovator specifications and the applied
formulation is present in available BP.
ii. Evidence of approval of applied formulation in applied
strength in reference authorities is required.
iii. Evidence of Me Too is required.
Previous decision(s) Deferred for the following reasons(M-272):
Evidence of approval of applied formulation in applied strength in
reference authorities.
Latest GMP inspection report conducted within the period of last
one year.
Evaluation by PEC The approval status of applied formulation has been confirmed in
PMDA Japan.The website link is as below:
http://www.pmda.go.jp/PmdaSearch/iyakuSearch/
Tamsolin 0.2mg capsule of M/s GETZ Pharma (Reg#061529).
Copy of inspection dated 08-08-2017, overall GMP compliance for
maintenance of testing equipment, machines, manufacturing areas,
utilities and documents/records were found quite satisfactory.
Decision: Approved.
576. Name and address of manufacturer / M/s Barret Hodgson Pakistan (Private) Ltd. F/423, SITE, Karachi
Applicant
Brand Name +Dosage Form + Strength VILDABAR film coated tablet 50mg
Vildagliptin …………..... 50mg
Diary No. Date of R& I & fee Dy. No. 919, Dated 10/11/2015,
Rs 20,000/= Dated 10/11/2015,
Finished product Specification In House
Pack size & Demanded Price Rs.770/- per 10’s, Rs.1078/- per 10’s,
Rs.1540/- per 20’sRs.2310/- per 30’s
Approval status of product in Reference GALVUS tablet by Novartis (TGA Approved).
Me-too status Vglip tablet 50mg by M/s Wellborne pharmachem and biologicals,
(Reg # 080908)
GMP status Last inspection report dated 14/04/2015 concludes,”The firm has
well maintained manufacturing unit with adequate facilities for the
manufacturing, testing and storage of raw/packaging materials and
finished products.
Previous remarks of the Evaluator.  The firm has claimed In House manufacturing specification and
the product is not present in USP/BP.
 The firm has applied for film coated tablet while the uncoated
tablet is approved in reference countries.
Previous decision(s) Deferred for the clarification since the applied product is film
coated while in reference country it is approved as plane
(uncoated) tablet.(M-274)
Evaluation by PEC The firm has submitted revised Form-5 from coated to uncoated
tablet in line with reference country. The correct label claim is as
follows:
Vildagliptin…………………50mg
Decision: Deferred for submission of fee for revision of applied formulation.
577. Name and address of manufacturer / M/s. Barrett Hodgson Pakistan, F/423, SITE, Karachi
Applicant
Brand Name +Dosage Form + Strength Angicare Tablet 5mg
Nicorandil ……………..5mg
Pharmacological Group Potassium channel blocker
Type of Form Form-5
Pack size & Demanded Price Pack of 10’s Rs. 130.00/-
Pack of 14’s Rs. 182.00/-
Pack of 20’s Rs. 260.00/-
Pack of 28’s Rs. 364.00/-
Pack of 30’s Rs. 390.00/-
Me-too status Nicoget (Getz) Reg. No. 045367
GMP status Last GMP inspection Date: 8-8-17, with Satisfactory cGMP
compliance
Previous remarks of the Evaluator. Provided reference of Sigmart 5mg Tablet (PMDA - Japan)
Ikorel (Sanofi-Aventis) can’t be confirmed.
Previous decision(s) Deferred for evidence of approval of applied formulation in
reference regulatory authorities/agencies which were
meeting(M-279).
Evaluation by PEC The approval status of applied formulation has been confirmed in
PMDA Japan. The website link is as below:
http://www.pmda.go.jp/PmdaSearch/iyakuSearch/
Decision: Approved.
578. Name and address of manufacturer / M/s Skims Pharmaceuticals, 10-B, Value Addition City
Applicant Khurrianwala, Faisalabad.
Brand Name + Dosage Form + Strength Skifen 600mg sachet
Diary No. Date of R & I & fee Diary No:6319, 20/02/2018, Rs. 20,000/-
Ibuprofen (effervescent granules)…600mg
Type of Form Form 5
Pack Size & Demanded Price 20‘s/ As per SRO
Approval Status of Product in Brufen Granules 600mg by M/s BGP Products Ltd. (MHRA
Reference Regulatory Authorities. Approved)
Me-too Status Hibufen 600mg Sachet by M/s Hirani (Reg#081554)
Panel recommends grant of Additional sections
Previous Remarks of the Evaluator. Approved formulation in MHRA contains Ibuprofen effervescent
granules but formulation applied by the firm has no mention of
effervescent granules.
Previous decision 281st Meeting of Registration Board held on 11th to 13th April, 2018.
Deferred for submission of fee for revision of formulation
Evaluation by PEC  Firm has submitted fee challan of Rs. 5000/- vide challan #
0740809 and submitted revised formulation for effervescent
granules
Decision: Approved.
579. Name and address of manufacturer / M/s Crystolite Pharmaceuticals, Plot No. 1 & 2, Street S-2,
Applicant National Industrial Zone, Rawat,
Brand Name+Dosage Form + Strength Malite Cream0.1%
Mometasone furoate…..1mg
Diary No. Date of R& I & fee Dy No.142; 02-11-2016; Rs.20,000/-
Pharmacological Group Anti-inflammatory &Antipruritic
Type of Form Form-5
Finished product Specification USP specifications
Pack size & Demanded Price 1’s(15gm) ; As per SRO
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Approval status of product in Approved in USFDA
Me-too status Momevate Cream 0.1 % of Pearl Pharmaceuticals
GMP status GMP Inspection report conducted on 17th October 2017 concluded
that firm is operating at good level of GMP.
Previous remarks of the Evaluator.  Primary packaging material of applied formulation is
plastic tube while in reference agenciesit is Aluminum tube;
however, the firm has submitted commitment that the firm will
conduct and submit complete stability studies to the DRAP with
these plastic tubes to justify that our product is stable with these
plastic tubes.
Previous decision(s) Registration Board was apprised that applied formulation is
available in Aluminum tube, in Reference Regulatory Authorities,
whereas, firm has applied for formulation in plastic tube.
Registration Board deliberated that difference in packaging
material is not considered as New Drug. So, no need to be applied
on Form 5D and such applications shall be treated as Me-
too/Generic, while stability studies data, as decided by Registration
Board in its 251st 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
by Registration Board.(M-277).
Evaluation by PEC The firm has submitted that we are changing the packing material
of applied formulation from plastic tube to Aluminum tube, as in
reference agencies.
Decision: Deferred for submission of fee for revision of packaging material.
580. Name and address of manufacturer / M/s Crystolite Pharmaceuticals, Plot No. 1 & 2, Street S-2,
Applicant National Industrial Zone, Rawat,
Brand Name+Dosage Form + Strength Malite ointment 0.1%
Mometasone furoate…..1mg
Pharmacological Group Anti-inflammatory &Antipruritic
Type of Form Form-5
Pack size & Demanded Price 1’s(15gm) ; As per SRO
Me-too status Monorate Ointment 0.1 % of Ambrosia Pharmaceuticals
GMP status GMP Inspection report conducted on 17th October 2017 concluded
that firm is operating at good level of GMP.
Previous remarks of the Evaluator.  Primary packaging material of applied formulation is
plastic tube while in reference agenciesit is Aluminum tube;
however the firm has submitted commitment that the firm will
conduct and submit complete stability studies to the DRAP with
these plastic tubes to justify that our product is stable with these
plastic tubes.
Previous decision(s) Registration Board was apprised that applied formulation is
available in Aluminum tube, in Reference Regulatory Authorities,
whereas, firm has applied for formulation in plastic tube.
Registration Board deliberated that difference in packaging
material is not considered as New Drug. So, no need to be applied
on Form 5D and such applications shall be treated as Me-
too/Generic, while stability studies data, as decided by Registration
Board in its 251st 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
by Registration Board.(M-277).
Evaluation by PEC The firm has submitted that we are changing the packing material
of applied formulation from plastic tube to Aluminum tube, as in
reference agencies.
Decision: Deferred for submission of fee for revision of packaging material.
581. Name and address of manufacturer / M/s Crest Pharmaceuticals, Plot No. 43, Industrial Triangle Kahuta
Applicant Road Islamabad.
Brand Name+Dosage Form + Strength Claricin Oral Powder Suspension 250mg/5ml
Clarithromycin Taste Masked EC Granules(27.5%)………..250mg
Diary No. Date of R& I & fee Diary No.412; 25-04-2017; Rs.20,000/- (25-04-2017)
Pharmacological Group Antibiotic (Macrolide)
Type of Form Form-5
Pack size & Demanded Price 60 ml/As per SRO
Approval status of product in Biaxin granules for oral suspension 250mg/5ml by M/s Abbvie,
Reference Regulatory Authorities. USFDA approved.
Me-too status Claritek Dry Suspension 250mg/5ml by M/s Getz Pharma
Inspection of Additional Sections.
Panel recommends grant of additional sections.
Previous remarks of the Evaluator.  Source of pellets Zhejiang Meike Phamraceuical Co.Ltd, China
 GMP certificate of pellet source valid till 28-12-2021
 Scope of GMP inspection: Capsule, Tablets
 Proof of approval of pellets from Relevant Regulatory
Authority is NOT confirmed
 Real time and accelerated stability study data of 3 batches
provided.
Real time: 6months
Accelerated: 3months
Previous decision(s) 274th Meeting Registration Board held on 21-23rd September, 2017.
Deferred for submission of differential fee for pellets from
imported source.
Deferred for submission of 6 months accelerated stability study
data of three batches of Clarithromycin Taste Masked EC
Granules(27.5%w/w) from supplier i.e. M/s Zhejiang Meike
Pharmaceutical Co.Ltd, China.(M-277)
Evaluation by PEC  The firm has submitted accelerated stability study data sheets of
three batches of Clarithromycin Taste Masked EC
Granules(27.5%w/w) conducted by M/s. Crest Pharma and copies
of COAs of three batches from supplier.
Decision: Deferred for submission of 6 months accelerated stability study data of three batches of
Clarithromycin Taste Masked EC Granules(27.5%w/w) from supplier i.e. M/s Zhejiang Meike
Pharmaceutical Co.Ltd, China.
582. Name and address of manufacturer / M/s Crest Pharmaceuticals, Plot No. 43, Industrial Triangle Kahuta
Applicant Road Islamabad.
Brand Name+Dosage Form + Strength Claricin Oral Powder Suspension 125mg/5ml
Clarithromycin Taste Masked EC Granules(27.5%)……..125mg
Diary No. Date of R& I & fee Diary No.411; 25-04-2017; Rs.20,000/- (25-04-2017)
Pharmacological Group Antibiotic (Macrolide)
Type of Form Form-5
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Pack size & Demanded Price 60 ml/As per SRO
(Reg#009846)
Previous remarks of the Evaluator.  Source of pellets Zhejiang Meike Phamraceuical Co.Ltd, China
 GMP certificate of pellet source valid till 28-12-2021
 Scope of GMP inspection: Capsule, Tablets
 Proof of approval of pellets from Relevant Regulatory
Authority is NOT confirmed
 Real time and accelerated stability study data of 3 batches
provided.
Real time: 6months
Accelerated: 3months
Previous decision(s) 274 Meeting Registration Board held on 21-23rd September, 2017.
th
Deferred for submission of differential fee for pellets from

imported source.
Deferred for submission of 6 months accelerated stability study
data of three batches of Clarithromycin Taste Masked EC
Granules(27.5%w/w) from supplier i.e. M/s Zhejiang Meike
Pharmaceutical Co.Ltd, China.(M-277)
Evaluation by PEC  The firm has submitted accelerated stability study data sheets of
three batches of Clarithromycin Taste Masked EC
Granules(27.5%w/w) conducted by M/s. Crest Pharma and copies
of COAs of three batches from supplier.
Decision: Deferred for submission of 6 months accelerated stability study data of three batches of
Clarithromycin Taste Masked EC Granules(27.5%w/w) from supplier i.e. M/s Zhejiang Meike
Pharmaceutical Co.Ltd, China.
583. Name and address of manufacturer M/s Shaigan Pharmaceuticals, Pvt limited, 14 Km, Adayala Road,
/ Applicant Post Office Dahgal, Rawalpindi.
Brand Name+Dosage Form + Strength Zevast Tablets 10mg/10mg
Ezetimibe ……………….10mg
Simvastatin.……………..10mg
Diary No. Date of R& I & fee Dy. No.3589 ; 27-12-2016; Rs.20,000/- (22-12-2016)
Pharmacological Group Cholesterol Absorption Inhibitor/HMG-CoA reductase inhibitor
Type of Form Form-5
Pack size & Demanded Price 1x10’s & Price as per SRO
Approval status of product in Not Provided
Me-too status Simbex tablet 10/10 of Searle Pharma
concludes issuance of GMP certificate for export purpose.
Previous remarks of the Evaluator. Non-pharmacopoeial as is not present in B.P. & U.S.P.
The drug is applied as film-coated while it is approved in USFDA,
MHRA, Netherland, Australia & France as uncoated.
Previous decision(s) Deferred for clarification of applied formulation since reference
product is approved as uncoated tablet whereas firm has applied for
film coated tablet.(M-278)
Evaluation by PEC  The firm has submitted revised Form-5 where the finished
product is uncoated tablet in line with reference country as follows
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584. Name and address of manufacturer / M/s Shaigan Pharmaceuticals, Pvt limited, 14 Km, Adayala Road,
Applicant Post Office Dahgal, Rawalpindi.
Pharmacological Group Lipid lowering agent/HMG-CoA reductase inhibitor
Type of Form Form-5
Previous remarks of the Evaluator. Non-pharmacopoeial as is not present in B.P. & U.S.P.
The drug is applied as film-coated while it is approved in USFDA,
MHRA, Netherland, Australia & France as uncoated.
585. Name and address of manufacturer / M/s Shaigan Pharmaceuticals, Pvt limited, 14 Km, Adayala Road,
Applicant Post Office Dahgal, Rawalpindi.
Pharmacological Group Cholesterol Absorption Inhibitor/statin
Type of Form Form-5
586. Name and address of manufacturer / M/s Linta Pharmaceuticals (Pvt) Limited, Plot # 3, Street no. S-5,
Applicant National Industrial Zone Rawat, Islamabad
Brand Name+Dosage Form + Strength Spix tablet 80mg/ 80mg
Phloroglucinol Dihydrate ..…………................80mg
Trimethylphloroglucinol………………………80mg
Pharmacological Group Antispasmodics
Type of Form Form-5
Pack size & Demanded Price 3x10’s & as per Drap policy
Approval status of product in Approved by ANSM of France
Me-too status Spadix 80mg/80mg tablets of M/s Tabros Pharma
concludes firm may be issued GMP certificate.
Previous decision(s) Deferred for clarification of dosage form since reference product is
available as sugar coated tablet whereas firm has applied for film
coated tablet. (M-279)
Evaluation by PEC The firm has submitted revised Form-5 with sugar coating in label
claim and master formulation in line with reference country:
Each sugar-coated tablet contains:
Phloroglucinol Dihydrate.…………................80mg
Trimethylphloroglucinol………………………80mg
587. Name and address of manufacturer / M/s Linta Pharmaceuticals (Pvt) Limited, Plot # 3, Street no. S-5,
Applicant National Industrial Zone Rawat, Islamabad
Brand Name+Dosage Form + Strength GD tablets 50mg
Vildagliptin ……………...50mg
Type of Form Form-5
Pack size & Demanded Price 2x14’s & as per Drap policy
Approval status of product in Approved as uncoated in Australia and France
Me-too status Galvus 50mg film-coated tablets of M/s Novartis, (Pak)
concludes firm may be issued GMP certificate.
Previous remarks of the Evaluator. Approved as uncoated in Australia and France.
available as uncoated tablet whereas firm has applied for film
coated tablet. (M-279)
Evaluation by PEC The firm has submitted revised Form-5 with uncoated tablet in label
claim and master formulation in line with reference country:
Vildagliptin ……………...50mg
588. Name and address of manufacturer / M/sWelmed Pharmaceutical Industries(Pvt)Ltd.
Applicant Plot No. 108- R-2,IndustrialEstate Gadoon, Dist. Swabi, KPK
Brand Name+Dosage Form + Strength Clarimed 250mg mg/5ml DrySuspension
Composition Diary No:6903, 21/06/2017, Rs: 20,000/-
Diary No. Date of R& I & fee Each 5 ml after reconstitution contains:
Clarithromycin…250mg
Type of Form Form 5
Pack size & Demanded Price 60 ml / As per SRO
(Reg#061347)
GMP status 04-03-2017, Renewal of DML and grant of additional sections
Panel recommendsgrantofadditional section
Previous remarks of the Evaluator.  Source of pellets not submitted by the firm.
Previous decision(s) Deferred for source of pellets, along with stability studies data,
GMP certificate of supplier and differential fee in case of import of
pellets.(M-277)
Evaluation by PEC Source of pellets: M/s Vision Pharmaceuticals
The firm has submitted copy of COA and stability study data of
three batches.
Decision: Approved.
589. Name and address of manufacturer / M/sWelmed PharmaceuticalIndustries(Pvt)Ltd.
Applicant Plot No. 108- R-2,IndustrialEstate Gadoon, Dist. Swabi, KPK
Brand Name +Dosage Form + Clarimed Drops 125mg/5ml Dry Suspension
Strength
Composition Diary No:6902, 21/06/2017, Rs: 20,000/-
Diary No. Date of R& I & fee Each 5 ml after reconstitution contains:
Clarithromycin…125mg
Pharmacological Group Antibiotic(Macrolide)
Type of Form Form-5
Pack size & Demanded Price 30ml /As perSRO
Approval status of product in Biaxin granules for oral suspension 125mg/5ml by M/sAbbvie,
Reference Regulatory Authorities. USFDAapproved.
Me-too status ClaritekDrySuspension125mg/5ml byM/sGetzPharma
(Reg#009846)
GMP status 04-03-2017, Renewal of DML and grant of additional sections
Panel recommendsgrantofadditional section
Previous remarks of the Evaluator.  Source of pellets not submitted by the firm.
Previous decision(s) Deferred for source of pellets, along with stability studies data,
GMP certificate of supplier and differential fee in case of import of
pellets.(M-277)
Evaluation by PEC Source of pellets: M/s Vision Pharmaceuticals
The firm has submitted copy of COA and stability study data of
three batches.
Decision: Approved.
590. Name and address of manufacturer / M/s. Welmark Pharmaceuticals ,Plot No.122, Block B, Phase V,
Applicant Industrial Estate, Hattar,
Brand Name+Dosage Form + Strength Esomark Sachet 10mg
Esomeprazole as Esomeprazole magnesium trihydrate (enteric
coated pellets)…………….10mg
Type of Form Form-5
Finished product Specification Manufacturer’s specs
Approval status of product in Nexium by Astrazeneca USA
Me-too status Nexum by GETZ
GMP status 16-09-2017, Routine GMP inspection compliant
Previous decision(s) Deferred for confirmation of me-too status of the applied product.
Evaluation by PEC  The firm has submitted copy of registration letter of “Navix
sachet of Wnsfield Reg#089776” for me-too reference.
591. Name and address of manufacturer / M/s Newton Health Care Pvt Ltd. Plot No: N -8&9, Hub
Applicant Balochistan.
Brand Name+Dosage Form + Strength Ursoton Dry Suspension 250mg/5ml
Composition Each 5ml reconstituted Suspension Contains:
Ursodeoxycholic acid…250mg
Diary No. Date of R& I & fee Dy No. 20316, 08-11-2017, Rs.20,000/= 07-11-2017
Pharmacological Group Bile acid preparations
Pack size & Demanded Price 60ml, 120ml /As per SRO
Approval status of product in Ursofalk® 250mg/5ml Suspension by M/s Dr. Falk Pharma UK
Reference Regulatory Authorities. Limited MHRA Approved
Me-too status Urso Suspension 250mg/5ml By AGP (Private) Ltd (Reg#076152)
GMP status New License
Previous remarks of the Evaluator.  Approved in RRA as suspension.
 Approved by DRAP as suspension dosage form.
Previous decision(s) Deferred for clarification of dosage form as reference product
approved by MHRA and DRAP is available as liquid suspension
while firm has applied as dry powder for suspension. (M-276)
Evaluation by PEC  The firm has submitted revised Form-5 from dry suspension to
liquid suspension in line with reference product.
 The firm has submitted fee challan of Rs. 5000/- (deposit slip #
0787602) dated 27-06-2018.
Decision: Approved with USP specifications
592. Name and address of manufacturer / M/s Paramount Pharmaceuticals, Plot No 36, Kahuta Road,
Applicant Islamabad.Remaining applications of additional
Section F. No. 6-4/2013-R-III dated 11-9-15
Brand Name+Dosage Form + Strength Cefy Tablet
Diary No. Date of R& I & fee Dy. No: 1726, dated.09-09-2015, Rs.20,000/-, dated. 08-09-2015
Cefixime Trihydrate…..450mg
Type of Form Form 5
Finished product Specification USP Specs.
Pack size & Demanded Price As per SRO/ 1x5’s
Approval status of product in Suprax by Lupin Pharma(USFDA)
Me-too status Sanxim by M/s Everest Pharma
GMP status Last GMP inspection was Conducted on 05.5.2017 with conclusive
remarks of Good cGMP compliance
Previous decision(s) Deferred in 254th meeting of RB for
Commitment as per 251st meeting of RB.
FTIR. Commitment provided.
Deferred for confirmation of approval status by reference
Regulatory authorities and Pakistan.(M-258)
Deferred for submission of fee for revision of formulation (M-277).
Evaluation by PEC Firm has submitted Form-5 with following composition:
Each film coated tablet contains:
Cefixime trihydrate eq. to cefixime…..400mg
Commitment has been provided.
The firm has submitted fee challan of Rs. 5000/- (Deposit slip #
0612604) dated 21-02-2018.
Decision: Approved.
593. Name and address of manufacturer / M/s Aries Pharmaceuticals (Pvt) Ltd.Industrial Estate, Hayatabad,
Applicant Peshawar.
Brand Name+Dosage Form + Strength Clomed Tablet 50mg
Diary No. Date of R& I & fee Diary No: 692, 26/04/2017, Rs: 20,000/-
Clomifene Citrate…50mg
Type of Form Form-5
Pack size & Demanded Price 10’s/ Rs:300/-
Approval status of product in Clomid 50mg Tablets by M/s Sanofi , MHRA approved
Me-too status Ovafin 50 mg tablet by M/s OBS (Reg#019173)
GMP status 10-03-17
Previous remarks of the Evaluator.  Brand name resembles already approved product by DRAP.
Previous decision(s) Deferred for consideration on its turn with respect to the queue.
(M-273).
Evaluation by PEC The firm has submitted for consideration of its application in
routine queue.
Copy of inspection report dated 04-06-2018 showed that the firm is
performing at satisfactory level of GMP.
Decision: Approved.
Applicant Peshawar.
Brand Name+Dosage Form + Strength Arotine Tablet 2.5mg
Diary No. Date of R& I & fee Diary No: 690, 26/04/2017, Rs: 20,000/-
Bromocriptine (as Mesilate)…2.5mg
Pharmacological Group Prolactine inhibitor/ Dopamine Receptor Agonist
Type of Form Form-5
Pack size & Demanded Price 30’s/ Rs:600/-
Approval status of product in Bromocriptine 2.5mg Tablets by M/s. Meda Pharma, MHRA
Reference Regulatory Authorities. approved
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Me-too status Parlodel 2.5 mg tablet by M/s Novartis(Reg#004714)
GMP status 10-03-17
Previous remarks of the Evaluator.  Brand name resembles already approved product by DRAP.
Previous decision(s) Deferred for consideration on its turn with respect to the queue as
the product cannot be manufactured in tablet (steroidal) section (M-
273).
routine queue.
The firm has provided tablet (hormone) section.
Decision: Approved.
Applicant Peshawar.
Brand Name+Dosage Form + Strength Arinal Injection 10mg
Nalbuphine (as hydrochloride)…10mg
Pharmacological Group Opioid Analgesic
Type of Form Form-5
Pack size & Demanded Price 1ml ampoule; As per SRO
Approval status of product in Nubain Injection 10mg/ml by M/s Sandoz Canada Incorporated,
Reference Regulatory Authorities. Health Canada approved
Me-too status Kinz 10mg/ml Injection by M/s Sami (Reg#018686)
GMP status 10-03-17
Previous decision(s) The Registration Board deferred the application for consideration
as per queue in Liquid ampoule injectable (General) section since
it does not fall under category of Liquid injection (Psychotropic)
and ten molecules for Liquid ampoule injectable (General) section
has already been considered (M-271).
routine queue.
Applicant Peshawar.
Brand Name+Dosage Form + Strength Arinal Injection 20mg
Nalbuphine (as hydrochloride)…20mg
Type of Form Form-5
Pack size & Demanded Price 1ml ampoule; As per SRO
Approval status of product in Nubain Injection 20mg/ml by M/s Sandoz Canada
Reference Regulatory Authorities. Incorporated,Health Canada approved
Me-too status Kinz 20mg/ml Injection by M/s Sami (Reg#018687)
GMP status 10-03-17
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has already been considered.(M-271)
Evaluation by PEC Copy of inspection report dated 04-06-2018 showed that the firm is
Applicant Peshawar.
Brand Name+Dosage Form + Strength Tramed Injection 50mg
Tramadol hydrochloride…50mg
Type of Form Form-5
Pack size & Demanded Price 1ml ampoules; As per SRO
Approval status of product in Tramadol 50mg/ml Solution for Injection or Infusion by M/s
Reference Regulatory Authorities. Beacon Pharmaceuticals, MHRA approved
Me-too status Tonoflex 50mg/ml Injection by M/s Sami (Reg#053224)
Applicant Peshawar.
Brand Name+Dosage Form + Strength Tramed Injection 100mg
Tramadol hydrochloride…100mg
Type of Form Form-5
Pack size & Demanded Price 2ml ampoules; As per SRO
Approval status of product in Tramadol 50mg/ml Solution for Injection or Infusion by M/s
Reference Regulatory Authorities. Beacon Pharmaceuticals, MHRA approved
Me-too status Tramal 50mg/ml Injection by M/s Searle (Reg#010072)
GMP status 10-03-17, Inspection of Additional Sections.
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599. Name and address of manufacturer /
Mass Pharma (Pvt.) Ltd, 17 km Ferozpur road, Lahore
Applicant
Brand Name+Dosage Form + Strength EEE-400 SOFT GELATIN CAPSULE 400MG
Composition Each Soft Gelatin Capsule Contains
Alpha Tocopheryl Acetate …..…400mg
Diary No. Date of R& I & fee Dy No.26962; Dated: 29-12-2017
Pharmacological Group Fat Soluble Vitamin ,Antioxidant
Type of Form Form 5
Finished product Specification Manufacturers Specifications
Pack size & Demanded Price 3x10’s: Rs. 500/= per Pack
Approval status of product in
Approved in US-FDA (EVION) (as provided by the firm)
Me-too status Zescap 400mg capsule Of Zafa Pharmaceutical Laboratories (Pvt)
Ltd. (drug infosis)
GMP status Date of inspection: 11-09-2017.
Purpose of inspection: Routine GMP
Conclusion: GMP complaint
Previous remarks of the Evaluator. Evidence of approval status of applied formulation in reference
agencies.
meeting.(M-279)
Evaluation by PEC The approval status in TGA, Australia submitted by the firm is in
Vitamin E 400 IU softgel capsule.
authorities/agencies as adopted by Registration Board in its 275th meeting as submitted reference is
not verifiable.
600. Name and address of manufacturer /
Mass Pharma (Pvt.) Ltd, 17 km Ferozpur road, Lahore
Applicant
Brand Name+Dosage Form + Strength DEE 50K SOFT GELATIN CAPSULE 50,000 IU
Composition Each Soft Gelatin Capsule Contains
Vitamin D3 (Cholecalciferol) BP …………50,000IU
Diary No. Date of R& I & fee 29-12-2017
Pharmacological Group Fat Soluble Vitamin
Type of Form Form 5
Finished product Specification Manufacturers Specifications
Pack size & Demanded Price 1x10’s: Rs. 400/= per Pack
1. EMA ( INVITA-D3)
Me-too status Vitamin D3 soft gel capsule of Mascon Pharma
GMP status Date of inspection: 11-09-2017.
Purpose of inspection: Routine GMP
Conclusion: GMP complaint
declared/approved by the Registration Board in its 275th meeting.
Evidence of applied formulation/drug already approved by DRAP
(generic / me-too status) alongwith registration number, brand
name and name of firm.(M-279)
Evaluation by PEC The approval status has been confirmed in MHRA (InVita D3
50,000 IU soft capsules).
Vitamin D3 softgel capsules of Mascon Pharmacal (Reg#059290)
601. Name and address of manufacturer / M/s Honig Pharmaceutical Laboratories,
Applicant 14Km, Adyala Road, Rawalpindi
Brand Name+Dosage Form + Strength Urolex Tablets
Composition Each film coated Tablet contains:
Tolterodine L-Tartrate……………...2mg
Diary No. Date of R& I & fee Fast track, Dy. No.5881, dated 11-09-2013, 11-09-2013
Pharmacological Group Genitorinary muscle relaxant, Blocks urinary bladder muscle
contraction competitive muscarinic receptor antagonism.
Type of Form Form 5
Finished product Specification Mfg. Specs.
Pack size & Demanded Price Rs.933.50; 2 x 14’s
Approval status of product in USFDA Approved
Me-too status (Detrusitol of Pfizer)
GMP status 05-12-2017, The company is found complying GMP as of today.
Previous decision(s) Deferred in (M-242) for completion of following documents:
Latest GMP inspection report,
Reference of finished product specification,
Evidence of approval of section,
Undertaking of conducting stability studies,process validation,
process development and analytical testing before marketing of
drug product.
Registration Board referred the case to QA & LT division to
confirm GMP status of the firm as critical observations are
mentioned in submitted inspection report (M-277).
Evaluation by PEC Latest GMP inspection report submitted.
Section approval submitted.
Copy of panel inspection conducted on 05-12-2017 showed that the
panel unanimously recommended for renewal of DML.
Decision: Approved with innovator’s specifications.
602. Name and address of manufacturer / M/s Avant Pharmaceutical (Previously Umema Pharmaceuticals)
Applicant Plot No. M 28 Hub Industrial Estate, Balochistan.
Contract Manufactured by: M/s Mediate Pharmaceuticals Plot150-
151, Sector 24, Korangi Industrial Area, Karachi
Brand Name+Dosage Form + Strength Utriaxone Injection 1g IV
Ceftriaxone (as sodium)…..1g
Type of Form Form-5
Finished product Specification USP Specifications
Approval status of product in Rocephin 1 g of Roche Products Ltd. UK (MHRA)
Me-too status Rocephin 1 g I.V by Roche (Pak) Ltd.
GMP status
Previous remarks of the Evaluator.  13% overage in master formulation.
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 Firm will deliver 5ml WFIbut in MHRA it should be 10ml.
Previous decision(s) Deferred for following:(M-275)
Justification on scientific basis for addition of 13% overage of API
in master formulation.
Clarification of instructions for reconstitution of injection in
comparison to reference product.
Evaluation by PEC The firm has submitted master formulation without overage.
The firm has submitted following reference for 5ml pack size:
Inj. Rocetec 1gm IV/IM of M/s. SPL Pharma (5ml) (Reg # 045517)
Inj. Halixophin of M/s Mediate Pharma (5ml) (Reg #
Copy of inspection dated 07-12-2017 concluded that overall rating
of the GMP was found good at the time of inspection.
Decision: Approved.
Contract Manufactured by:M/s Mediate Pharmaceuticals Plot 150-
151, sector 24, Korangi Industrial area, Karachi
Brand Name+Dosage Form + Strength Utriaxone Injection 500mg IV
Ceftriaxone (as sodium)……..500mg
Diary No. Date of R& I & fee Dy No.1168 ; 17-12-2015; Rs.50,000/-
Type of Form Form-5
Approval status of product in Rocephin 500 mg of Roche Products Ltd. UK (MHRA)
Me-too status Signum 500mg Injection IV of Cherwel pharmaceuticals.
GMP status
Previous remarks of the Evaluator.  13% overage in master formulation.
Previous decision(s) Deferred for justification on scientific basis for addition of 13%
overage of API in master formulation. (M-275)
Evaluation by PEC The firm has submitted master formulation without overage.
Decision: Approved.
Brand Name+Dosage Form + Strength U-Span Capsule 400mg
Cefixime(astrihydrate)…………..400mg
Type of Form Form-5
Pack size & Demanded Price As per PRC
Approval status of product in Suprax 400 mg of Lupin Ltd. USA (USFDA)
Me-too status Obpan 400mg capsules of Obsonspharma
GMP status
Previous remarks of the Evaluator.  Firm has claimed manufacturer specifications but has not
submitted the data as required by the decision of 267th
meeting and applied formulation is not present in available
USP and B.P
 Incorrect master formulation.
Previous decision(s) Deferred for submission of correct master formulation (M-275).
Evaluation by PEC The firm has submitted correct master formulation for the applied
product.
Decision: Approved with Japenese Pharmacopoeia specifications and change of brand name
Applicant Plot No.M 28 Hub Industrial Estate, Balochistan.
Brand Name+Dosage Form + Strength U-Span Dry Suspension 100mg/5ml
Cefixime(as trihydrate)…100mg
Type of Form Form-5
Pack size & Demanded Price 1’s of 30ml; As per PRC
Approval status of product in USFDA approved.
Me-too status CEFSPAN by Barrett Hodgson Pakistan (Pvt) ltd.
GMP status
Previous remarks of the Evaluator.  Incorrect master formulation.
 Manufacturing method is of injection instead of
suspension.
Previous decision(s) Deferred for submission of following: (M-275)
 Correct master formulation
 Manufacturing method for applied product.
Evaluation by PEC The firm has submitted correct master formulation and outline of
method of manufacture for the applied product.
Decision: Approved and change of brand name
Applicant Plot No.M 28 Hub Industrial Estate, Balochistan.
Brand Name+Dosage Form + Strength U-Span Dry Suspension 200mg/5ml
Cefixime(as trihydrate)…200mg
Type of Form Form-5
Pack size & Demanded Price 1’s of 30ml; As per PRC
Approval status of product in USFDA approved.
Me-too status CEFSPAN by Barrett Hodgson Pakistan (Pvt) ltd.
GMP status
Previous remarks of the Evaluator.  Incorrect master formulation.
Manufacturing method is of injection instead of
suspension.
Previous decision(s) Deferred for submission of following: (M-275)
 Correct master formulation
 Manufacturing method for applied product.
Evaluation by PEC The firm has submitted correct master formulation and outline of
method of manufacture for the applied product.
Decision: Approved and change of brand name
607. Name and address of manufacturer / M/s Jenner Pharmaceuticals (Pvt.) Ltd., 26th KM, Lahore-Sharikpur
Applicant Road, Sheikhupura
Brand Name+Dosage Form + Strength Jenzol capsules 30mg
Lansoprazole (as enteric-coated 8.5% pellets)……30 mg
Pharmacological Group Anti-Peptic Ulcerant, Proton Pump Inhibitor
Type of Form Form-5
Approval status of product in Lansoprazole 30mg GR capsules of M/s Generics limited (UK
Reference Regulatory Authorities. MHRA Approved)
Me-too status Inhibitol capsules 30mg of M/s Highnoon Laboratories
concludes:
“Overall the firm is satisfactory regarding building,
equipment and functioning of HVAC system. However, they were
advised to improve their documentation regarding the production
and quality control, they agreed.”
Previous remarks of the Evaluator.  Source of pellets is M/s Smilax Laboratories Ltd (India).
 GMP certificate of the source has lost its validity as is valid
upto 21-02-2017.
 CoA has been provided of the source.
 Stability data of pellets has been submitted.
Previous decision(s) Deferred for submission of differential fee of Rs. 80,000/- for
import of pellets and also for submission of valid GMP certificate
of supplier of pellets.(M-279)
Evaluation by PEC The firm has submitted photocopy of fee challan of Rs. 80,000/-
(Deposit slip # 0606158) dated 16-03-2017.
Copy of GMP certificate issued by DCA, Telangana, India valid
upto 19-04-2021 was submitted by the firm.
Decision: Approved.
608. Name and address of manufacturer / M/s. Siam Pharmaceutical, 217 Industrial Triangle, Kahota Road ,
Applicant Islamabad
Brand Name+Dosage Form + Strength NeoQuel tablet 25mg
Quetiapine (as Fumarate)………………...…..25mg
Type of Form Form-5
Pack size & Demanded Price 3x 10’s: As per SRO
Approval status of product in Approved in MHRA as film-coated
Me-too status Pequit tablets of M/s Medizan Pharmaceuticals
GMP status Last GMP inspection conducted on 16-02-2018 recommended
renewal of DML.
Previous remarks of the Evaluator.  Applied as uncoated while is approved as film-coated in
MHRA.
available as film coated tablet whereas firm has applied for
uncoated tablet.(M-279)
Evaluation by PEC The firm has submitted revised Form-5 with film coating in label
claim and master formulation and fee challan of Rs. 5000/- (Deposit
slip # 0708602) dated 07-06-2018.
EachFilm coated tablet contains:
Quetiapine (as Fumarate)………………...…..25mg
Decision: Approved.
Applicant Islamabad
Brand Name+Dosage Form + Strength NeoQuel tablet 100mg
Quetiapine (as Fumarate)………………..100mg
Type of Form Form-5
Approval status of product in Approved in MHRA as film-coated
renewal of DML.
Previous remarks of the Evaluator. Applied as uncoated while is approved as film-coated in MHRA.
slip # 0708603) dated 07-06-2018.
Each Film coatedtablet contains:
Decision: Approved.
Applicant Islamabad
Brand Name+Dosage Form + Strength NeoQuel XR tablet 150mg
Composition Each XR tablet contains:
Type of Form Form-5
Approval status of product in MHRA Approved
renewal of DML.
Previous remarks of the Evaluator. Applied as uncoated while is approved as film-coated
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slip # 0708604) dated 07-06-2018.
Each Extended release Film coatedtablet contains:
Decision: Approved.
Applicant Islamabad
Brand Name+Dosage Form + Strength NeoQuel XR tablet 300mg
Composition Each XR tablet contains:
Type of Form Form-5
Approval status of product in MHRA Approved
renewal of DML.
Previous remarks of the Evaluator. Applied as uncoated while is approved as film-coated
slip # 0708605) dated 07-06-2018.
Each Extended release Film coatedtablet contains:
Decision: Approved.
612. Name and address of manufacturer / M/s Amaan Pharmaceuticals, 30km, Sheikhupura Road Lahore.
Applicant
Brand Name+Dosage Form + Strength Ketamine Injection 100mg/2ml
Ketamine hydrochloride………50mg
Pharmacological Group General anaesthetic
Type of Form Form-5
Finished product Specification BP Specifications
Pack size & Demanded Price 5’s(2ml); Rs.275/- per 2ml× 5ampoules
Approval status of product in Approved in Germany(as provided by the firm)
Me-too status Ketarol Injection of Global Pharma (Reg # 026630)
GMP status Last Inspection of M/s Amman Pharmaceuticals conducted on 10-
04-2017 gives some advises to the firm, management has shown
their commitment to further up-grade the unit. Re-inspection shall
be conducted to verify the up-gradation status on GMP audit
Performa after one month.
Previous remarks of the Evaluator. i. Step of terminal sterilization has been missing in
manufacturing method.
ii. Firm has applied for ketamine hydrochloride 100mg/2ml
Injection packed in ampoule while in reference agencies it
is approved as follow.
Previous decision(s) Deferred in 273rd meeting for the following:
agencies.
 Step of terminal sterilization has not been mentioned in
manufacturing outline. Clarify or justify the same.
Evaluation by PEC  The firm has submitted revised Form-5 alongwith fee challan
of Rs.5000/- (deposit slip # 0747803) dated 07-05-2018
clarifying salt form as under:
 Each ml contains:
Ketamine as hydrochloride…….50mg which is in line with
reference country (USFDA).
 The firm has mentioned terminal sterilization by autoclaving.
 GMP inspection dated 11-05-2018 concludes that overall
quality control. Firm showed good intention to improve further.
 Innovator product and me-too are in 10ml multi dose vial while
firm has applied ampoule of 2ml.
Decision: Deferred for clarification of pack size of applied formulation since reference product is in
10ml vial while the firm has applied in 2 ml ampoule.
Evaluator PEC-III
613. Name and address of manufacturer / M/s Regal Pharma Plot No. 2A, street S-5, National Industrial Zone,
Applicant Rawat Islamabad.
Brand Name +Dosage Form + Strength O-Mox Tablet 400mg
Moxifloxacin (as hydrochloride)………….400mg
Pharmacological Group Fluoroquinolone antibiotic
Type of Form Form 5
Approval status of product in Reference Avelox Tablet by Bayer
Me-too status Avelox Tablet by Bayer
Case history ● This file has been presented in 260th meeting of Registration
Board as case of New License/Section. This case was deferred in
261st meeting since this product exceeded the 10 molecule per
section priority. The Registration Board deferred this case for
evaluation on its turn. Now the case is presented before the Board.
Remarks of the Evaluator. ● Firm has initially applied for tablet containing moxifloxacin
400mg, later on the firm has submitted that they had mistakenly
written moxifloxacin instead of moxifloxacin as hydrochloride.
Now the firm has requested to consider their application with salt
as per the reference product. Firm has not submitted any fee for
revision.
Decision of 282nd meeting of RB Deferred for submission of fee for revision of formulation.
Evaluation by PEC: Firm has submitted fee for revision of formulation PKR 20,000/-
vide chalan No. 0757305 dated 01-06-2018.
Brand Name +Dosage Form + Strength Epiwell 250mg CR Tablet
Divalproex sodium eq to valproic acid…….250mg
Type of Form Form 5
Pack size & Demanded Price 1x10’s, 3x10’s, 10x10’s: As per SRO
Approval status of product in Reference Depakote Tablet by Abbott
Me-too status Depakan tablets by Platinum Pharmaceuticals
Case history ● This file has been presented in 260th meeting of Registration Board
as case of New License/Section. This case was deferred in 261st
meeting since this product exceeded the 10 molecule per section
priority. The Registration Board deferred this case for evaluation
on its turn. Now the case is presented before the Board.
Remarks of the Evaluator. ● Firm has initially applied for sustained release tablet containing
divalproex sodium 250mg while the reference product approved by
USFDA contains valproic acid 250mg as divalproex sodium. The
firm has submitted that they have mistakenly written sustained
release tablet instead of enteric coated tablet. Firm has submitted
PKR 5,000/- fee via chalan (0757303) dated 30-04-2018 for change
in applied formulation.
Evaluation by PEC: Firm has submitted fee for revision of formulation PKR 20,000/-
Decision: Approved.
Brand Name +Dosage Form + Strength Epiwell 500mg CR Tablet
Diary No. Date of R& I & fee (DUPLICATE DOSSIER) 9-6-2016 PKR 20,000/-: 8-6-2016
Divalproex sodium eq to valproic acid…….500mg
Type of Form Form 5
Pack size & Demanded Price 1x10’s, 3x10’s, 10x10’s: As per SRO
Approval status of product in Reference Depakote ER Tablet by Abbott
Me-too status Epival CR Tablet by Abbott Pharma
Remarks of the Evaluator. ● Firm has initially applied for controlled release tablet containing
divalproex sodium 500mg. Later the firm has submitted that they
have mistakenly written divalproex sodium 500mg instead of
divalproex sodium eq to valproic acid 500mg. The firm has
requested to consider their application of divalproex sodium eq to
valproic acid 500mg. Firm has not submitted any fee for this
revision.
Evaluation by PEC: Firm has submitted fee for revision of formulation (PKR 20,000/-
Decision: Approved.
Brand Name +Dosage Form + Strength Re-Spa Tablet 80mg
Drotaverine hydrochloride…..80mg
Type of Form Form 5
Approval status of product in Reference Approved by Hungary, Latvia, and Lithuania as uncoated tablet.
Me-too status Deserve tablets by semos pharma
Remarks of the Evaluator. ● Firm has initially applied for film coated tablet containing
drotaverine as hydrochloride 80mg, later the firm has requested to
change their formulation to uncoated tablet containing drotaverine
hydrochloride 80mg.
Evaluation by PEC: Firm has submitted fee for revision of formulation (PKR 20,000/-
617. Name and address of manufacturer / Hoover Pharmaceuticals (Pvt) Ltd., Plot No. 16, Zain Park, Sagian
Applicant by pass road, Lahore
Brand Name +Dosage Form + Strength DIANEXT MR 30mg Tablets
Diary No. Date of R& I & fee Dy No. 1320: 18-10-2010
PKR. 8000/: (18-10-2010) + PKR 12000/-: (26-6-2014)
Composition Each modified release tablet contains:-
Gliclazide…..30mg
Pharmacological Group (Anti-Diabetic)
Type of Form Form 5
Approval status of product in Reference Bilxona 30mg modified release tablets by Actavis UK
Me-too status Glinext tablet by Novamed
GMP status Last inspection report 20-1-2017 Panel recommended the grant of
additional section.
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259
Remarks of the Evaluator. ●
Decision of 279th meeting of RB Registration Board referred the case to QA & LT Division to conduct
GMP inspection of Firm on priority. The Board also directed the firm
to change the brand name
Evaluation by PEC: Firm has submitted GMP certificate issued on the basis of inspection
Firm has submitted following two new brand names
1. Diatron MR 30
2. Diaglic MR 30
618. Name and address of manufacturer / Hoover Pharmaceuticals (Pvt) Ltd., Plot No. 16, Zain Park, Sagian
Applicant by pass road, Lahore
Brand Name +Dosage Form + Strength DIANEXT MR 60mg Tablets
PKR. 8000/: (18-10-2010)+PKR 12000/-: (26-6-2014)
Composition Each modified release tablet contains:-
Gliclazide…..30mg
Pharmacological Group (Anti-Diabetic)
Type of Form Form 5
Approval status of product in Reference Bilxona 30mg modified release tablets by Actavis UK
Me-too status Glinext tablet by Novamed
GMP status Last inspection report 20-1-2017 Panel recommended the grant of
additional section
Decision of 279th meeting of RB Registration Board referred the case to QA & LT Division to conduct
GMP inspection of Firm on priority. The Board also directed the firm
to change the brand name
Evaluation by PEC: Firm has submitted GMP certificate issued on the basis of inspection
Firm has submitted following two new brand names
1. Diatron MR 60
2. Diaglic MR 60
619. Name and address of manufacturer / M/s. Aries Pharmaceuticals (Pvt) Ltd. 1-W, Industrial Estate,
Applicant Hayatabad Peshawar, Pakistan
Brand Name +Dosage Form + Strength Sulcare Tablets 25mg
Rs.8000/-:15-8-2012 + Rs.12,000/-: 17-07-2014
Levosulpiride………….25mg
Pharmacological Group Benzamide antipsychotic
Type of Form Form 5
Pack size & Demanded Price 2x10’s: As Per SRO
Approval status of product in Reference LEVOPRAID 25 mg tablet by TEOFARMA Srl - Via F.lli Cervi
Regulatory Authorities. (AIFA Italy Approved)
Me-too status Sulvo 25mg Tablet by Medisure
GMP status 10-03-17: Panel recommends grant of additional sections
Decision of 277th meeting of RB Deferred for the submission of GMP report conducted within the last
01 Approved with innovator’s specifications.
Evaluation by PEC: Firm has submitted GMP inspection report dated 4-6-2018
confirming satisfactory compliance to GMP.
620. Name and address of manufacturer / M/s Aulton Pharmaceuticals, Plot 84/1, Block A, Phase
Applicant 5, Industrial Estate, Hattar
Brand Name +Dosage Form + Strength Cure – H Sachet
Diary No. Date of R& I & fee Dy No. 102: 18-5-2016PKR 20,000/-: 18-5-2016
Composition Each Sachet Contains:-
L-Ornithine-L-aspartate……..3000 mg
Pharmacological Group Hepatoprotectant
Type of Form Form 5
Me-too status Hepa-Merz sachet by Brookes Pharma
GMP status Last GMP inspection report dated 11-01-2017 confirms
satisfactory compliance to GMP
Remarks of the Evaluator. ● Evidence of approval in reference regulatory authorities could not
be confirmed
Decision of 274th meeting of RB Deferred for evidence of approval by reference regulatory
authorities.
Evaluation by PEC: Firm has submitted following documents:
 Evidence of approval of applied formulation by DIMDI Germany
with following details
Hepa-Merz Granules 3000by Merz Pharmaceuticals
 Last inspection report dated 13-2-2018 confirming good
compliance to GMP
Evaluator PEC-II
621. Name and address of manufacturer / M/s Wimits Pharmaceuticals, Sundar Industrial Estate, Raiwind
Applicant Road, Lahore
Brand Name +Dosage Form + Strength Mecowim 500mcg tablet
Composition Each sugar coated contains:
Mecobalamin .….. 500mcg
Diary No. Date of R& I & fee Dy. No.N/A;06-04-206; Rs.20,000/- (06-04-2016)
Pharmacological Group Antianemic agent
Type of Form Form-5
Finished product Specification Manufacturers specification
Pack size & Demanded Price 2 x 10’s; Rs. 200/- 10 x 10’s; Rs. 1400/-
Approval status of product in Approved by PMDA of Japan
Me-too status Mecomed 500mcg by Global Pharma (Reg. No. 041670)
GMP status Copy of GMP certificate issued by Additional Director, DRAP
Lahore, based upon evaluation conducted on 03-11-2017
Remarks of the Evaluator. Firm has claimed manufacturer specifications whereas JP
monograph is available for applied formulation.
Previous Decision: Registration Board in its 279th meeting deferred for clarification of
pharmacological group.
Evaluation by PEC: Firm has submitted as under:
“Mecobalamin is a Vitamin B-12 co-enzyme that occurs in blood
and cerebrospinal fluid. Mecobalamin is taken by nerve tissues
more actively and extensively than other homologues of Vitamin
B-12. Mecobalamin accelerates the synthesis of nucleic acid in
bone marrow as well as promotes the maturation and division of
eryhtroplast and haeme synthesis, resulting in an increase in
erythrocyte (RBCs) production.”
WHO ATC index also classifies Mecobalamin as “Antianemic
preparations”
Decision: Approved with Innovator’s specifcations
622. Name and address of manufacturer / M/s Cirin Pharmaceuticals, Pvt Ltd.32/2-A,phase-III, Industrial
Applicant Estate, Hattar, KPK, Pakistan
Brand Name +Dosage Form + Strength Bisocor 2.5mg tablet
Bisoprolol as (fumarate)………2.5mg
Type of Form Form 5
Approval status of product in Cardicor 2.5mg tablet Of ( MHRA Approved)
Me-too status Biscot 2.5mg Tablet Of M/SScotmann Pharmaceuticals,
concludes that firm is maintained as per GMP requirement
Remarks of the Evaluator.  Last inspection report not within one year
Previous Decision: Registration Board in its 279th meeting referred the case to QA &
LT Division to conduct GMP inspection of Firm on priority.
Evaluation by PEC: Firm has submitted copy of last inspection conducted on 07-05-
Decision: Approved.
Brand Name +Dosage Form + Strength Bisocor 5mg tablet
Bisoprolol as (fumarate)………5mg
Type of Form Form 5
Approval status of product in Cardicor 5mg tablet Of ( MHRA Approved)
Me-too status Biscot 5mg Tablet Of M/SScotmann Pharmaceuticals,
concludes that firm is maintained as per GMP requirement
Evaluation by PEC: Firm has submitted copy of last inspection conducted on 07-5-2018
and report concludes good level of cGMP compliance.
Decision: Approved.
Brand Name +Dosage Form + Strength Bisocor 10mg tablet
Bisoprolol as (fumarate)………10mg
Type of Form Form 5
Approval status of product in Cardicor 10mg tablet Of ( MHRA Approved)
Me-too status Biscot 10mg Tablet Of M/SScotmann Pharmaceuticals,
report concludes that firm is maintained as per GMP requirement
Decision: Approved.
Brand Name +Dosage Form + Strength Varox 10mg tablet
Rivaroxaban………10mg
Pharmacological Group (Anticoagulant)
Type of Form Form 5
Approval status of product in Xarelto 10mg tablet Of ( USFDA Approved)
Me-too status Xarelto 10mg Tablet Of M/S Bayer
concludes that firm is maintained as per GMP requirement .
Previous Decision: Registration Board in its 279th meeting decided that reference will
be sent to Budget & Accounts Division for verification of challan
and Board authorized its Chairman for the issuance of registration
letter.
Decision: Approved with Innovator’s specifcations.
Brand Name +Dosage Form + Strength Varox 15mg tablet
Rivaroxaban………15mg
Pharmacological Group (Anticoagulant)
Type of Form Form 5
Finished product Specification Manufacturer,s specification
Approval status of product in Xarelto 15mg tablet Of ( USFDA Approved)
Me-too status Xarelto 15mg Tablet Of M/S Bayer
concludes that firm is maintained as per GMP requirement .
Brand Name +Dosage Form + Strength EVA 5mg Tablet
Ivabradine HCl eq.to Ivabradine ……...5mg
Diary No. Date of R& I & fee Dy. No. 1737 , 30-03-2017; Rs.20,000/- (30-03-2017)
Pharmacological Group Selective sinus node inhibitor
Type of Form Form 5
Finished product Specification Innovator Specification
Pack size & Demanded Price Alu-Alu Blister 14’s 28’s Rs. As per SRO
Approval status of product in Corlanor (USFDA approved)
Me-too status Sivab Tablet 5 mg of M/s Getz Pharma (Pvt.) Ltd
concludes that overall the firm has maintained GMP guidelines.
Remarks of the Evaluator. Firm has claimed manufacturer’s specifications and no official
monograph is available for applied formulation in USP & BP.
GMP inspection needs to be conducted.
Brand Name +Dosage Form + Strength EVA 7.5mg Tablet
Ivabradine HCl eq.to Ivabradine ……...7.5mg
Pharmacological Group Selective sinus node inhibitor
Type of Form Form 5
Finished product Specification Manufacturers Specification
Pack size & Demanded Price Alu-Alu Blister 14’s 28’s Rs. As per SRO
Approval status of product in Corlanor (USFDA approved)
Me-too status Sivab Tablet 5 mg of M/s Getz Pharma (Pvt.) Ltd
Remarks of the Evaluator. Firm has claimed manufacturer’s specifications and no official
monograph is available for applied formulation in USP & BP.
GMP inspection needs to be conducted.
Brand Name +Dosage Form + Strength Effector Plus Tablet 5mg/160mg/25mg
Amlodipine besylate eq. to Amlodipine…….5mg
Valsartan………………………………….160mg
Hydrochlorothiazide…………………...…..25mg
Pharmacological Group Valsartan- angiotensin II receptor antagonist Amlodipine
besylate- calcium channel blockers Hydrochlorothiazide-thiazide
diuretics
Type of Form Form 5
Finished product Specification USP Specification
Pack size & Demanded Price Alu-Alu Blister 14’s Rs. As per SRO
Approval status of product in Exforge HCT Of M/S Novartis (USFDA Approved)
Me-too status Exforge HCT of Novartis Pharma (Pak) Ltd
Remarks of the Evaluator.  GMP inspection needs to be conducted.
 Approved in reference authorities with boxed warning of
fetal toxicity.
Brand Name +Dosage Form + Strength Effector Plus Tablet 10mg/160mg/25mg
Amlodipine besylate eq. to Amlodipine…….10mg
Valsartan…………………………………...160mg
Hydrochlorothiazide…………………...……25mg
diuretics
Type of Form Form 5
Pack size & Demanded Price Alu-Alu Blister 14’s Rs. As per SRO
Me-too status Exforge HCT of M/s Novartis Pharma (Pak) Ltd
fetal toxicity.
Brand Name +Dosage Form + Strength Effector Plus Tablet 10mg/160mg/12.5mg
Amlodipine besylate eq. to Amlodipine……...10mg
Valsartan…………………………………….160mg
Hydrochlorothiazide…………………...……12.5mg
diuretics
Type of Form Form 5
Pack size & Demanded Price 14’s Rs. As per SRO
Me-too status Exforge HCT Tablets of M/s Novartis Pharma (Pak) Ltd
fetal toxicity.
Brand Name +Dosage Form + Strength Krystor 5mg Tablet
Rosuvastatin (as calcium salt)……………5mg
Pharmacological Group HMG-CoA reductase inhibitor
Type of Form Form 5
Pack size & Demanded Price 10’s 20’s 30’s & As per SRO
Approval status of product in Approved in Netherland
Me-too status Rovista Tablet 5 mg Getz Pharma (Pvt.) Ltd
Type of Form Form 5
Me-too status Rovista Tablet 10mg Getz Pharma (Pvt.) Ltd
Type of Form Form 5
Type of Form Form 5
Brand Name +Dosage Form + Strength Corinef suspension 200mg/5ml
Composition Each 5ml suspension on reconstitution contains:
Cefixime………….……200mg
Type of Form Form-5
Me-too status (with strength and Aksoxime 200mg/5ml suspension
dosage form)
GMP status Last inspection conducted on 07-09-2016 and report concludes that
firm is of GMP compliant.
Remarks of the Evaluator Latest GMP inspection report not conducted within last one year.
However, the firm has applied for issuance of certificate of GMP
on 15-08-2017.
Previous Decision: Registration Board in its 274th meeting deferred the case for
submission of latest inspection report conducted within last one
year.
Decision: Approved.
ii. Veterinary
Evaluator PEC-XIV
637. Name and address of manufacturer / M/s. Majestic Pharma., Plot # 21, Phase-1A, M-3, Industrial City,
Brand Name +Dosage Form + Strength FLOTOX Powder
Composition Each Kg contains
Sodium Benzoate………………..500 g
Ethanol B Aminophosphoric acid ………. 100 g
Vitamin A…………………….. 10000000 IU
Vitamin E……………………. 2500 mg
Vitamin K3…………………. 1000mg
Vitamin C………………….. 2500 mg
Pharmacological Group Diuretic/Toxin Binder
Type of Form Form-5
Finished Product Specification In-house specifications
Pack size & Demanded Price 100 g, 250g, 500g, 1 Kg, 5Kg; Decontrolled
Approval status of product in Reference N/A
Me-too status Diurizone powder of M/s. Mylab (Reg # 073908)
GMP status CLB in 256th meeting approved the grant of new DML to M/s.
Majestic Pharma, Faisalabad
Previous decision Deferred for rationale of Ethanol in applied formulation.
(M-279)
Evaluation by PEC  The firm has submitted that rationale of Ethanol beta amino
phosphoric acid is concerned with weight gain and modifying the
eating habit of the bird. It is also concerned with energy process
of the body, a process which is absolutely indispensable to the
working of cells and in particular the nerve and muscle cells.
Decision: Deferred for confirmation of approval status of “Ethanol B Aminophosphoric acid” as a
single ingredient in reference countries which were adopted by the Registration Board in its 275th
meeting.
638. Name and address of manufacturer / M/s. Majestic Pharma., Plot # 21, Phase-1A, M-3, Industrial City,
Brand Name +Dosage Form + Strength TYCODIN-M Oral W/S Powder
Composition Each Kg contains:
Tylosin Tartrate ……………….. 200 gm
Doxycycline HCL……………… 400 gm
Colistin Sulphate ……………… 500 MIU
Bromhexine HCL………………. 10 g
Type of Form Form-5
Pack size & Demanded Price 100 g, 250g, 500g, 1 Kg, 5Kg; Decontrolled
Me-too status MEXIN PLUS WSP of M/s. Mylab (Reg # 058956)
GMP status CLB in 256th meeting approved the grant of new DML to M/s.
Majestic Pharma, Faisalabad
Remarks of the Evaluator. The submitted me-too is of different strength. Correct reference is
required to be submitted.
Previous 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.(M-279)
Evaluation by PEC  The firm has submitted that correct strength mentioned in the
dossier was Colistin sulphate………..1000MIU which has been
verified from the dossier. Now the correct formulation is as
under:
 Each Kg contains:
Tylosin Tartrate ……………….. 200 gm
Doxycycline HCL……………… 400 gm
Colistin Sulphate ……………… 1000 MIU
Bromhexine HCL………………. 10 g
639. Name and address of manufacturer / M/s Univet Pharmaceuticals, 14-Km, Adayala road, post office
Applicant Dahga, Rawalpindi
Brand Name +Dosage Form + Strength HEPAWIN SOLUTION
Composition Each ml contains:-
L-Carnitine ….………………50mg
Betain HCL…..……………...20mg
Inositol ……………………….7mg
Choline Chloride …..………100mg
Sorbitol ……………………...200mg
Magnesium Sulphate…….……10mg
Diary No. Date of R& I & fee Dy. No.44, R&I Dated 18-01-2016, (NO EVIDENCE OF FEE)
Pharmacological Group Vitamins
Type of Form Form -5
Finished Product Specification In-house
Pack size & Demanded Price 100ml,500ml,1000ml; De-controlled price
Me-too status HEPTIC solution of M/s Evergreen Pharma (Reg#072689)
GMP status Last (panel) inspection was conducted on 02-10-2014 which
concludes grant of additional section namely oral liquid general
section Veterinary (General).
Previous decision Deferred for confirmation of fee submission date (M-277).
Evaluation by PEC The firm has submitted fresh fee challan of Rs. 20,000/- (Deposit
slip # 0746073) dated 27-02-2018.
Inspection conducted on 26-10-2017 showed no observation as
reported by QA.
640. Name and address of manufacturer / M/s Univet Pharmaceuticals, 14-Km, Adayala road, post office
Applicant Dahga, Rawalpindi
Brand Name +Dosage Form + Strength FLUMECOL LIQUID
Flumequine ………………….20g
Colistin sulphate……………....2g
Diary No. Date of R& I & fee Dy. No.45, R&I Dated 18-01-2016, (NO EVIDENCE OF FEE)
Pack size & Demanded Price 100ml,500ml, 1000ml; De-controlled price
Me-too status Flu-Col liquid of M/s Leads Pharma
GMP status Last (panel) inspection was conducted on 02-10-2014 which
concludes grant of additional section namely oral liquid general
section Veterinary (General).
Previous decision Deferred for confirmation of fee submission date (M-277).
Evaluation by PEC The firm has submitted fresh fee challan of Rs. 20,000/- (Deposit
slip # 0746072) dated 27-02-2018.
Inspection conducted on 26-10-2017 showed no observation as
reported by QA.
Me-too reference could not be verified.
641. Name and address of manufacturer / M/s Mylab (Pvt) Ltd, Khankah Sharif, Bahawalpur.
Applicant
Brand Name +Dosage Form + Strength Captalin Injection 763
Composition 197, 05-12-2014, 31-05-2012, Rs.8000/- (Photocopy attached), 01-
12-2014, Rs.12000/-
Diary No. Date of R& I & fee Each ml contains:-
Spiramycin……….…..…105 MIU
Type of Form Form-5
Pack size & Demanded Price Glass vial of 50ml ; Decontrolled
Me-too status Mycogal 105 injection of Lachman (Reg#043111)
GMP status GMP inspection conducted on 08-10-2015 showed overall
cleanliness was good but some advises were given for further
improvements.
Remarks of the Evaluator. The submitted me-too reference does not match with proposed
formulation in terms of strength
Previous decision Deferred for submission of latest GMP inspection report conducted
within 1 year and Evidence of me-too status as stated reference is
incorrect. (M-269)
Deferred for confirmation of generic / me-too status. (M-276)
Evaluation by PEC Firm has submitted copy of last inspection report conducted on 31-
07-2017. The submitted inspection report declares that
observations made during inspection on 08-10-2015 have been
rectified. Moreover the conclusion of report is as under:
“It is a veterinary unit. Overall Cleanliness was good. Firm has
improved with regards to previous inspection. Firm is developing
the dedicated penicillin area and assured that production of
penicillin containing drugs shall remain stopped in compliance to
decision of CLB.”
Photocopy of fee challan (8000/-) is attached but the endorsement
is original.
 The firm has submitted Revised Form-5 alongwith fee challan
of Rs. 5000/- (Deposit slip#0777159) dated 23-05-2018 and
correct formulation is as under
 Each 100ml contains:-
Spiramycin adepate………..…105 MIU
642. Name and address of manufacturer / M/s. Vetz Pharmaceuticals (Private) Limited, Plot # Q-1, S.I.T.E.
Applicant Kotri Sindh.
Brand Name +Dosage Form + Strength Predex Injection
Imidocarb Dipropionate……..120 mg
Pharmacological Group Anti-protozoal
Type of Form Form-5
Pack size & Demanded Price Decontrolled
10 ml, 20 ml, 50 ml, 100 ml
Approval status of product in Reference Imidocarb 120 mg injection (USFDA)
Me-too status IMIDOX Injection of Ghazi Brother (Reg# 043593)
GMP status The inspection conducted on 24-10-2017 concluded as:
“Maintenance of required quality of air and temperature as well as
cleanliness of the facility, its design to facilitate cleaning was found
nicely managed. The implementation of quality oversight and
control over the manufacturing of drugs was found well attended
by the entire team under their best capacity. The ability of
management, enthusiasm to walk with scientific standards was
visible and remarkable. The exercise to understand the entire status
of compliance with emerging regulatory expectations is under way
and will be recorded accordingly”.
Previous decision Deferred for the clarification of indicated species, since applied
formulation is not indicated in pet, poultry and dogs (M-276).
Evaluation by PEC The firm has submitted reference from Plumb’s Veterinary Drug
which states as “ Imidocarb is approved for use to treat Babesia
canis infections (Babesiosis) in dogs, but the drug may be
efficacious against Ehrlichia canis in this species. Imidocarb may
be of benefit in treating babesia and related parasitic diseases in a
variety of domestic and exotic animals.”
Brand Name +Dosage Form + Strength Vetzazene injection
Diminazine Aceturate……………105mg
Antipyrine…….……………..……131mg
Pharmacological Group Antiprotozoa
Type of Form Form-5
Pack size & Demanded Price 10ml; Decontrolled
Me-too status Pronil Injection of Selmore Pharma (Reg # 029609)
Previous decision Deferred for the clarification regarding chemical structure/nature
of antipyrine in applied formulation(M-277).
Evaluation by PEC  The firm was communicated to provide rationale of antipyrine
in applied formulation. In response firm has submitted that
 “Diminazene aceturate is an antiprotozoal substance active
against the following babesiosis (piroplasmosis) causing
agents: Babesia bigemina, Babesia divergens, Babesia bovis in
cattle; Babesia caballi and Babesia equi in horses; Babesia ovis
in sheep; Babesia canis and Babesia gibsoni in dogs and
Theileria annulata in cattle. It is highly effective against
Trypanosoma congolense and Trypanosoma vivax and
moderately active against Trypanosoma bruceï, Trypanosoma
evansi and Trypanosoma equiperdum.
 Antipyrine (phenazone) is an analgesic, a nonsteroidal anti-
inflammatory drug (NSAID) and an antipyretic. It reduces fever
especially in case of babesiosis.
 Reference: Plumb’s veterinary drug hand book sixth edition
(Donald.C Plumb, Pharm-D, USA).
 Chemically, antipyrine is 1,2-Dihydro-1,5-dimethyl-2-phenyl-
3H-pyrazol-3-one and synonyms are Phenazone and
Analgesine.
 The firm has submitted reference of literature which shows that
antipyrine in the injection formulation acts as stabilizer and
used for inflammation and fever.
Decision: Registration Board referred the case to Expert working group on Veterinary Drugs for review
of this formulation.
Brand Name +Dosage Form + Strength Vetzveta injection I.M/I.V
Vitamin B1 …………..4mg
Vitamin B6 …………0.34mg
Vitamin B2 …………..0.17mg
Vitamin C ………………4mg
L-Arginine HCL …….…1.44mg
L-Cystine HCL ………….3.2mg
L.Glutamine HCL ……….3.2mg
Glycin ………………….…3.2mg
L.Histidine ………..……1.32mg
L.Isoleucine ……………..3.6mg
L.Leucine HCL…………..4.28mg
L.Lysine HCL……. ……5.44mg
L.Methionine …….……3.2mg
L.Threonine …………..3.2mg
L.Trypton ……….…….0.86mg
L.Valine ……….………3.6mg
Nicotinamide ………..…8mg
Glucose ……….………021mg
Magnesium Sulphate …….0.08mg
L.Phenylalanine ……….….5mg
Pharmacological Group Aminoacid/Vitamin
Type of Form Form-5
Pack size & Demanded Price 100 ml; Decontrolled
Me-too status Not submitted.
number, brand name and name of firm. (M-276)
Evaluation by PEC The firm has submitted me-too reference “Aminovital injection of
Star Lab (Reg # 023491)” which has been verified from database.
645. Name and address of manufacturer / M/s Evergreen Pharmaceuticals, Ferozpur Road,Lahore.
Applicant
Brand Name +Dosage Form + Strength COLIST GOLD Powder
Colistin sulphate.………………..5000,000IU
Type of Form Form-5
Pack size & Demanded Price 500gm, 1Kg, 5Kg, 10Kg ; Decontrolled
Me-too status Biocolis of biocure Pharma
GMP status The panel inspection conducted on 03-01-2018 recommended the
renewal of DML of M/s. Evergreen Pharma.
Remarks of the Evaluator. The submitted me-too reference is of different strength. Provide
correct reference.
number, brand name and name of firm(M-279).
Evaluation by PEC The firm has submitted me-too reference “COLISTIN WSP of
Biogen Pharma (Reg#071022) which has been verified from
available database of DRAP.
Decision: Approved with innovator’s specification and change of brand name.
Case No. 02: Registration Applications of Newly Granted DML or New section (Human)
a. New DML
Evaluator PEC-VI
M/s Delta Pharma Pvt Ltd, Risalpur

CLB in its 256 meeting held on 9 -10th November 2017 has considered and re-grant DML by way of formulation
th th
for the following sections

a) Tablet section(General)
b) Capsule section(General)
Tablet General Section: 11 Products/ 11 Molecules

646. Name and address of manufacturer / M/s Delta Pharma Pvt Ltd, Risalpur
Applicant
Brand Name +Dosage Form + Strength Peroxat-CR 25mg tablets
Composition Each enteric coated controlled release tablet contains:
Paroxetine as HCl…….25mg
Pharmacological Group SSRI
Type of Form Form-5
Me-too status Panox CR tablet 25mg of M/s Regal Pharmaceuticals
GMP status
Decision: Deferred for confirmation of already granted registrations of prodcuts on priority after
grant of DML by CLB in its 256th meeting held on 9th-10th November 2017.
Applicant
Brand Name +Dosage Form + Strength Betadox tablets
Piroxicam B cyclo dextrin 191.2mg eq to Piroxicam……20mg
Type of Form Form-5
Approval status of product in Reference CYCLADOL 20mg Tablet ANSM France Approved
Me-too status Ripax 20mg by Hilton
GMP status
Applicant
Brand Name +Dosage Form + Strength Centa 1mg tablets
Cinitapride hydrogen tartarate eq to Cinitapride……1mg
Type of Form Form-5
Pack size & Demanded Price 10’s, 5x10’s As per SRO
Approval status of product in Reference Approved in Spanish Agency of Medicines and Health
Regulatory Authorities. Products
Me-too status Cinic tablet of Fynk Pharma (Reg # 074446)
GMP status
Applicant
Brand Name +Dosage Form + Strength F.C Dole tablets
Caffeine…..65mg
Chlorpheniramine maleate……2mg
Pharmacological Group Narcotic, Analgesic, Antihistamine
Type of Form Form-5
Pack size & Demanded Price 100’s,200’s, Rs.2 per tablets
Me-too status Hesmol Extra tablets Reg # 078571
GMP status
Applicant
Brand Name +Dosage Form + Strength G.Floxin 320mg tablets
Gemifloxacin as mesylate……320mg
Type of Form Form-5
Approval status of product in Reference Factive 320mg tablets (USFDA approved)
Me-too status Gatiking 320mg tablets of M/s Welwrd Pharmaceuticals
GMP status
Applicant
Brand Name +Dosage Form + Strength Altezole 2.5mg tablet
Letrozole…..2.5mg
Pharmacological Group Non-Steroidal Aromatase Inhibitor
Type of Form Form-5
Pack size & Demanded Price 3x10’s As per SRO
Approval status of product in Reference FEMARA 2.5 mg Tablet by M/s Novartis Pharmaceuticals
Me-too status Aromek 2.5mg Tablet by M/s Glaxy Pharmaceuticals
(Reg#052258)
GMP status
Applicant
Brand Name +Dosage Form + Strength Rostin 10mg tablet
Rosuvastatin as clacium……..10mg
Pharmacological Group Statins
Type of Form Form-5
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
GMP status
Applicant
Brand Name +Dosage Form + Strength Linzodel 400mg tablet
Linezolid……..400mg
Type of Form Form-5
Me-too status Ecasil tablet of M/s Sami Pharmaceuticals (Reg. # 067162)
GMP status
Applicant
Brand Name +Dosage Form + Strength Claricin 500mg tablets
Clarithromycin……500mg
Type of Form Form-5
Approval status of product in Reference Clarithromycin 500mg Film-coated Tablets by M/s Ranbaxy
Regulatory Authorities. (UK) Limited, (MHRA approved)
Me-too status CLARION 500MG TABLET by M/s. 'Ferozsons Labs
(Reg#0002873)
GMP status
Applicant
Brand Name +Dosage Form + Strength Tonolix tablets
Tramadol….37.5mg
Paracetamol……325mg
Type of Form Form-5
GMP status
Applicant
Brand Name +Dosage Form + Strength Moxin 400mg tablet
Moxifloxacin as HCl….400mg
Type of Form Form-5
Me-too status Metoxim 400mg Tablet by M/s Foray Pharmaceutical
(Reg No:056083)
GMP status
Capsule general Section: 3 Products/ 3 Molecule
Applicant
Brand Name +Dosage Form + Strength R.P.Zole 20mg capsule
Rabeprazole sodium (enteric coated pellets)….20mg
Type of Form Form-5
Approval status of product in Reference Not confirmed
Me-too status Rabecap Capsules 20mg by M/s Aries Pharmaceuticals (Pvt.)
Ltd (Reg#069725)
GMP status
Remarks of the Evaluator. Pellets are obtained from vision pharma.
 Approval status of product in Reference Regulatory
Applicant
Brand Name +Dosage Form + Strength Omesure 40mg capsule
Omeprazole (enteric coated pellets)……40mg
Type of Form Form-5
Pack size & Demanded Price 2x7’s, Rs 230/-
Approval status of product in Reference Losec 40 mg by by AstraZeneca UK (MHRA approved)
Me-too status Risek 40mg by Getz
GMP status
Remarks of the Evaluator. Pellets are obtained from Vision Pharma
Applicant
Brand Name +Dosage Form + Strength Eso.del 40mg capsule
Esomeprazole (as Magnesium trihydrate enteric coated
pellets)………….…40mg
Type of Form Form-5
Approval status of product in Reference Nexium capsules 20mg of M/s AstraZeneca Pharmaceuticals
Me-too status Ezium capsules of M/s Searle Pharmaceuticals
(Reg. # 035621)
GMP status
Remarks of the Evaluator. Pellets are obtained from Vision Pharma
Evaluator PEC-VII
Case. No.1. M/s Fahmir pharma 26 km Lahore, Jaranwala Road, Main stop Mandianwala Tehsil Sharaqpur,
Dist. Sheikupura (New DML)
CLB in its 259th meeting held on 29-30th March, 2018 has considered and approved the grant of drug manufacturing
license by way of formulation with following three (03) sections
Accordingly, firm has applied for following products for consideration by Drug Registration Board.
Sr. No Section No. of products No. of molecules

1 Tablet section (General)
2 Capsule section (General) 3 1
3 Sachet section (General) 4 4
660. Name and address of Manufacturer / M/s Fahmir pharma 26 km, Lahore, Jaranwala Road, Main stop
Applicant Mandianwala Tehsil Sharaqpur, Dist. Sheikupura
Brand Name+ Dosage Form+ Strength Ispamir Sachet
Mebeverine as HCl …135 mg
Ispaghula husk………3.5 mg
Diary No. Date of R&I & fee Dy No. 17469 ; 11-5-2018; Rs.20,000/-
Pharmacological Group Anti-Spasmodic
Type of Form Form-5
Pack Size & Demanded Price As per SRO
Approval status of product in Reference Fybogel Mebeverine effervescent granules by M/s Reckitt
Regulatory Authorities Benckiser Healthcare (UK) Ltd. (MHRA approved
Me-too status Colospas Fibro 135mg/3.5g powder by M/s Nabiqasim. (Reg#
058672)
GMP status New DML
Brand Name+ Dosage Form+ Strength Omir Plus Sachet
Omeprazole…40mg
Sodium bicarbonate…1680mg
Pharmacological Group Proton Pump Inhibitor/antacid
Type of Form Form-5
Approval status of product in Reference ZEGERID Powder for Oral Suspension by M/s Santarus, Inc.
Regulatory Authorities (USFDA Approved)
Me-too status Risek Insta Sachet 40mg + 1680mg by M/s Getz Pharma
(Reg.No.058548),
GMP status New DML
Decision: Approved
Brand Name+ Dosage Form+ Strength Smectamir Sachet
Dioctahedral smectite………..3g
Pharmacological Group Anti-diarrheal
Type of Form Form-5
Approval status of product in Smecta 3 g powder for oral suspension in sachet by M/s Ipsen
Reference Regulatory Authorities Pharma (ANSM approved)
Me-too status Diosecta 3g sachet by M/s Woodwards Pharma. (Reg# 061111)
GMP status New DML
Brand Name+ Dosage Form+ Strength Montimir 4 mg Sachet
Montelukast sodium eq. to Montelukast……………4mg
Pharmacological Group Leukotriene Receptor antagonist
Type of Form Form-5
Pack Size & Demanded Price Rs. 13 per sachet / 182/- per 14’s (As per SRO)
Approval status of product in Singulair Sachet 4mg Granules of Merck , USFDA
Me-too status Montiget Sachet of Getz Pharma ( Reg # 044046)
GMP status New DML
Capsule Section (General)

Brand Name+ Dosage Form+ Strength Tacromir 0.5 mg capsule
Tacrolimus as monohydrate….. 0.5mg
Pharmacological Group Antineoplastic and Immunomodulating agents (Calcineurin
inhibitors)
Type of Form Form-5
Approval status of product in Reference Prograf (0.5mg, 1mg, 5mg) hard capsules by M/s Astellas Pharma
Regulatory Authorities Ltd, MHRA Approved.
Me-too status Inograf capsule 0.5mg by M/s Platinum Pharma (Reg # 045490)
GMP status New DML
Remarks of Evaluator Registration Board previously 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.
which remain in direct contact or are involved in close handling of these drugs.
Brand Name+ Dosage Form+ Strength Tacromir 1 mg capsule
Tacrolimus as monohydrate….. 1 mg
inhibitors)
Type of Form Form-5
Pack Size & Demanded Price 30 capsule. Rs.39.1/-
Regulatory Authorities Ltd, MHRA Approved
Me-too status Inograf capsule by M/s Platinum Pharma
GMP status New DML
Brand Name+ Dosage Form+ Strength Tacromir 5 mg capsule
Tacrolimus as monohydrate….. 5 mg
inhibitors)
Type of Form Form-5
Pack Size & Demanded Price 10 capsule. Rs.212.5/-
Regulatory Authorities Ltd, MHRA Approved
Me-too status Inograf capsule by M/s Platinum Pharma
GMP status New DML
Evaluator PEC-XIV
Capsule section (5molecules/10 Products)
667. Name and address of manufacturer / M/s Fahmir Pharma (Pvt.) Ltd, Sheikhupura
Applicant
Brand Name +Dosage Form + Strength BFR20-20mg Capsule
Esomeprazole as magnesium trihydrate (22.5% Enteric
coated) pellets…………………20mg
Type of Form Form-5
Pack size & Demanded Price 14’s / Rs160.00
Approval status of product in Reference Nexium 20mg capsule of Pfizer, USFDA
Me-too status Wesome capsule of Wellness Pharma (Reg # 078758)
GMP status The firm was granted new DML in 259th meeting of CLB
held on 29th& 30th March, 2018.
Remarks of the Evaluator. Source of pellets: M/s. Vision Pharma.
COA, stability study data of batches and valid GMP
certificate granted based on evaluation on 26-01-2018
were submitted.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength BFR40-40mg Capsule
Esomeprazole as magnesium trihydrate (22.5% Enteric
coated) pellets…………………40mg
Type of Form Form-5
Approval status of product in Reference Nexium 40mg capsule of Pfizer, USFDA
Me-too status Wesome capsule of Wellness Pharma (Reg # 078757)
were submitted.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength OMIR-20mg Capsule
Omeprazole (Enteric coated pellets 22.5%)………20mg
Type of Form Form-5
Approval status of product in Reference Prilosec 20mg of Astrazeneca, USFDA
Me-too status Losec capsule of Barret Hodgson (Reg # 010800)
were submitted.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength OMIR-40mg Capsule
Omeprazole (Enteric coated pellets 22.5%)………40mg
Type of Form Form-5
Approval status of product in Reference Prilosec 20mg of Astrazeneca, USFDA
Me-too status Omega capsule of Barret Hodgson (Reg # 050818)
were submitted.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Diclomir-50mg Capsule
Diclofenac sodium EC pellets (24%)……………50mg
Type of Form Form-5
Approval status of product in Reference Deflamate 50mg Capsule of Atellas, Austria
Me-too status Neurofenac 50 capsule of AD Marker (Reg # 010193)
were submitted.
Applicant
Brand Name +Dosage Form + Strength Diclomir-100mg Capsule
Diclofenac sodium EC pellets (24%)……………50mg
Type of Form Form-5
Approval status of product in Reference Dedolor DRS 100mg Kapsiln of Astellas, Austria
Me-too status Disney 100mg Capsule of Irza Pharma (Reg # 067823)
were submitted.
Applicant
Brand Name +Dosage Form + Strength Dexomir-60mg Capsule
Dexlansprazole pellets 17%…………60mg
Type of Form Form-5
Pack size & Demanded Price 10’s (3’s) / Rs. 696.00
Approval status of product in Reference Dexilant 60mg capsule, USFDA
Me-too status Razodex 60mg capsule of Getz
were submitted.
Stability study data as per 278th meeting of Registration
Board are required to be submitted for applied
formulation.
Decision: Deferred for submission of stability data for applied formulation as checklist
approved in 278th meeting.
Applicant
Brand Name +Dosage Form + Strength Dexomir-30mg Capsule
Dexlansprazole pellets 17%…………30mg
Type of Form Form-5
Pack size & Demanded Price 10’s (3’s) / Rs. 696.00
Approval status of product in Reference Dexilant 60mg capsule, USFDA
Me-too status Razodex 60mg capsule of Getz
were submitted.
Stability study data as per 278th meeting of Registration
Board are required to be submitted for applied
formulation.
Decision: Deferred for submission of stability data for applied formulation as checklist
approved in 278th meeting.
Applicant
Brand Name +Dosage Form + Strength ZUBIMIR-200mg Capsule
Fluconazole……………200mg
Type of Form Form-5
Pack size & Demanded Price 1’s ; Rs. 159.00
Me-too status Diflucan 200mg capsules of M/s Pfizer Pharma
(Reg. # 011829)
Decision: Approved with Japenese Pharmacopoeia specification.
Applicant
Brand Name +Dosage Form + Strength ZUBIMIR-150mg Capsule
Fluconazole……………150mg
Type of Form Form-5
Pack size & Demanded Price 1’s ; Rs. 159.00
Me-too status Diflucan 150mg capsules of M/s Pfizer Pharma
(Reg. # 011828)_
Decision: Approved with Japenese Pharmacopoeia specification.
M/s Perk Pharma (Pvt) Ltd, Gadoon Amazai Swabi, KPK
Central Licensing Board in its 254thmeeting granted approval of new DML by way of formulation for following
sections
1. Tablet section (General)
2. Capsule section (General)
3. Dry powder suspension section (General)
4. Oral Liquid Section (General)
DML No. 000857 (dated 24-08-2017)
Capsule section (4 molecules/ 5Products)
677. Name and address of manufacturer / M/s Perk Pharma (Pvt) Ltd, Gadoon Amazai Swabi, KPK
Applicant
Brand Name +Dosage Form + Strength ORLIS 120mg capsule
Orlistat IR pellets 50% equivalent to Orlistat……120mg
Source of pellets: M/s Vision Pharmaceuticals, Islamabad
Pharmacological Group Lipase Inhibitor
Type of Form Form-5
Pack size & Demanded Price 30’s & 84’s: As recommended by PRC
Approval status of product in Orlistat 120mg by Pharmaceutical Works POLPHARMA SA
Reference Regulatory Authorities. Poland (MHRA approved)
Me-too status Fabical 120mg capsules by Highnoon
GMP status 01/04/2017; Inspection for grant of new DML
Panel recommends grant of DML
Remarks of the Evaluator. The firm has submitted revised Form-5 with correct label
alongwith fee challan of Rs. 20,000/- (Deposit slip # 0555397)
dated 13-06-2018.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength DOXETINE 60mg Capsule
Duloxetineas HCl enteric coated pelletspellets 17% w/w
……………60mg
Pharmacological Group SNRI
Type of Form Form-5
Pack size & Demanded Price Blister pack of 7’s; As recommended by PRC
Approval status of product in Cymbalta of (USFDA approved)
Me-too status Swenta 60mg Capsule by M/s Martin Dow
GMP status 01/04/2017
Inspection for grant of new DML
dated 13-06-2018.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength DOXETINE 30mg Capsule
Duloxetineas HCl enteric coated pelletspellets
17%……………30mg
Pharmacological Group SNRI
Type of Form Form-5
Pack size & Demanded Price Blister pack of 7’s; As recommended by PRC
Approval status of product in Cymbalta of (USFDA approved)
Me-too status Swenta 30mg Capsule by M/s Martin Dow
GMP status 01/04/2017
Inspection for grant of new DML
dated 13-06-2018.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Permocin 0.4mg capsule
Tamsulosin hydrochloride SR pellets 0.2%............0.4mg
Pharmacological Group Alpha adrenergic antagonist
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s; As per SRO
Approval status of product in Flomax 0.4mg capsule by M/s Boehringer Ingelheim
Reference Regulatory Authorities. Pharmaceuticals (USFDAApproved)
Me-too status Tamflo 0.4mg SR Capsule by M/s Genome Pharma
(Reg#074562)
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength PERVERINE 200mg Capsule
Mebeverine hydrochloride (SR pellets 50%)……..200mg
Pharmacological Group Drugs for functional gastrointestinal disorders (Synthetic
anticholinergics, esters with tertiary amino group)
Type of Form Form-5
Pack size & Demanded Price 10’s /As per SRO
Approval status of product in Colofac MR. Modified release capsule 200mg by M/s Mylan
Reference Regulatory Authorities. Products Limited (MHRA approved)
Me-too status Mebever MR 200mg capsule by M/s Getz Pharma Pvt. Ltd.
(Reg#050754)
dated 13-06-2018.
Decision: Approved.
New/Additional section(s)
Evaluator PEC-VIII
CLB in its 256th meeting held on 9th-10th November 2017 has considered and approved the grant of 03 additional
sections to M/s Rogen pharma:
a) Capsule section(General)
b) Sachet section (General)
c) Topical lotion & Gel section(General)
Details of the molecules and products applied by the firm is stated in the table below:
Sr.No. Section Molecules Products

1 Capsule section(General) 04 04
2 Sachet section (General) 04 04
3 Topical lotion &Gel section(General) 01 01
Capsule section(general): molecules: 04; products: 04
682. Name and address of Manufacturer / M/s Rogen Pharmaceuticals (Pvt.) Ltd. Plot #: 30, Street No. S-4,
Brand Name + Dosage Form +Strength Duloxin Capsules 20 mg
Other proposed brand names:
Duloren capsules 20mg
Dulox-R capsules 20mg
Delor capsule 20mg
Composition Each Delayed-release Capsule contains
Duloxetine (as hydrochloride) …….20 mg
Source of pellets; Vision pharmaceuticals
Diary No. Date of R&I & fee DyNo.19806; 30-05-2018; Rs. 20000/-
Pharmacological Group Selective Serotonin and Norepinephrine Reuptake Inhibitors
Type of Form Form-5
Pack Size & Demanded Price ; As per SRO
Me-too status Zenbar capsule 20mg by M/s Searle, Karachi
GMP status New Section (Issuance Date: 19th December 2017)
Remarks of Evaluator COA and GMP of pellet's manufacturer and stability studies both
real time and accelerated of three batches of pellets conducted in
accordance with zone IV-A
Conditions.
(Firm has submitted the required documents)
Decision: Approved.
Brand Name + Dosage Form +Strength Rogever Capsules 200 mg
Rozin capsules 200mg
Ropril capsules 200mg
Mebeverine hydrochloride….200mg
Pharmacological Group Anticholinergic
Type of Form Form-5
Approval status of product in Approved in US-FDA
Me-too status Mepasm MR 200mg capsules of Martin dow.
Remarks of Evaluator COA and GMP of pellet's manufacturer and stability
studies both real time and accelerated of three batches of
pellets conducted in accordance with zone IV-A
Conditions.
Reference product is approved as mebeverine
hydrochloride 200mg capsules containing pellets which
is different from applied formulation i.e. mebeverine
hydrochloride 200mg plain capsules containing powder.
Justification on scientific basis for addition of 3 %
overage in master formulation.
Decision: Approved with Innovator’s specifications.
Brand Name + Dosage Form +Strength Litrogen Capsules 2.5 mg
Litrogrip Capsules 2.5mg
Ligen Capsules 2.5mg
Letrozole….2.5mg
Pharmacological Group Aromatase inhibitors
Type of Form Form-5
Approval status of product in Could not be confirmed
Remarks of Evaluator Evidence of approval of applied formulation in reference
regulatory authorities/agencies which were declared/approved by
the Registration Board in its 249th meeting.
Evidence of applied formulation/drug already approved by DRAP
(generic / me-too status) alongwith registration number, brand
name and name of firm.
Justification on scientific basis for addition of 3 % overage in
master formulation.
Decision: Registration Board rejected the application as applied formulation is neither approved by
any reference regulatory authority nor by the Registration Board.
Brand Name + Dosage Form +Strength Desom capsules 3/25mg
Deprol Capsules 3/25mg
Depflux Capsules 3/25mg
Olanzapine……………...3 mg
Fluoxetine (as hydrochloride)...…25 mg
Pharmacological Group SSRIs / Antipsychotic
Type of Form Form-5
Pack Size & Demanded Price 14’s & 30’s ; As per SRO
Approval status of product in Symbyax 3 mg/25 mg Capsules of Eli Lilly , USA (USFDA)
Me-too status Olanzo-F 3/25 mg Capsules of Regal pharmaceuticals
Decision: Approved.
Sachet section(general): molecules: 04; products: 04
Brand Name + Dosage Form +Strength Omegen Sachet 20mg
Omeprazol…20mg
Type of Form Form-5
Decision: Deferred for submission of fee for revision of formulation from Omeprazole 20mg to
Omeprazole 20mg & sodium bicarbonate 1100mg sachet.
Brand Name + Dosage Form +Strength Polergen Sachet 4mg
Motelukast (as sodium)…4mg
Type of Form Form-5
Me-too status Astel Sachet 4mg of M/s Fynk Pharmaceuticals,
Decision: Approved with USP Specifications.
Brand Name + Dosage Form +Strength Gen-C Sachet 685/20/200/500mg
Calcium carbonate….685mg
Calcium Gluconate…20mg
Calcium Lactate….200mg
Ascorbic acid….500mg
Pharmacological Group Calcium + Vitamin
Type of Form Form-5
Me-too status Astel Sachet 4mg of M/s Fynk Pharmaceuticals,
Remarks of Evaluator Justification on scientific basis for addition of 7% &12% overage
in quantities of Calcium carbonate&Ascorbic acid in master
formulation.
(Firm has submitted master formulation without overage.)
Brand Name + Dosage Form +Strength Sacfit Sachet 250mg
Saccharomyces Bouldrii…250mg
Pharmacological Group Anti-diarrheal
Type of Form Form-5
Me-too status Actiflor sachet 250mg of Pharmevo
Remarks of Evaluator Justification on scientific basis for addition of 7% overage in
master formulation.
Evidence of approval of applied formulation in reference
regulatory authorities/agencies which were declared/approved by
the Registration Board in its 275th meeting.
Decision: Registration Board referred the case to Health & OTC division for processing of this
formulation since it contains probiotic.
Topical Lotion & Gel section(general): molecules: 01; products: 01
Brand Name + Dosage Form +Strength Ronac Gel 1%
Diclofenac diethylamine eq.to diclofenac sodium…10mg
Type of Form Form-5
Finished Product Specification BP Specifications
Pack Size & Demanded Price 50gm; As per SRO
Reference Regulatory Authorities (Voltaren gel 1% 50grams/20grams)
Me-too status Diclodium Gel 1% of Ferozesons Laboratories
Decision: Approved with BP specification
Evaluator PEC-I
M/s Jaens Pharmaceutical Industries (Pvt) Ltd., 28-km sheikhupura road, lahore.
(09 Molecules /09 products)
Opthalmic Ointment Section
691. Name and address of manufacturer M/s Jaens Pharmaceutical Industries (Pvt) Ltd, 28-km
Sheikhupura Road, Lahore.
Brand Name +Dosage Form + Strength ORCYDEX eye ointment
Composition Each gram contains: -
Dexamethasone …1mg (0.1%w/w)
Tobramycin …3mg (0.3%w/w)
Pharmacological Group Corticosteroid + Antibiotic
Type of Form Form-5
Pack size & Demanded Price 3.5g Aluminum tube /As per SRO
Approval status of product in Reference TOBRADEX (Dexamethasone; Tobramycin)0.1%;0.3%
Regulatory Authorities. Ointment;Ophthalmic| Novartis Pharms Corp;
(US-FDA Approved)
Me-too status EyeBradex Eye Ointment
by M/s Barrett Hodgson (Reg#083290)
GMP status CLB in its 260th meeting held on 16th April 2018, vide letter no.
F.1-8/2001-Lic. Approved the approval of following two
additional sections:-
1. Topical Preparation Section
2. Ophthalmic Ointment Section
Decision: Approved.
692. Name and address of manufacturer M/s Jaens Pharmaceutical Industries (Pvt) Ltd,
28-km Sheikhupura Road, Lahore.
Brand Name +Dosage Form + Strength ORCYeye ointment 0.3%w/w
Tobramycin …3mg (0.3%w/w)
Type of Form Form-5
Pack size & Demanded Price 5g Aluminium tube /As per SRO
Approval status of product in Reference TOBREX (tobramycin) 0.3% | Ointment; Ophthalmic| Novartis
Regulatory Authorities. Pharms Corp. (US-FDA Approved)
Me-too status TOBREX (tobramycin) 0.3% (Reg#008250)
Decision: Approved.
Brand Name +Dosage Form + Strength CLOVIR eye ointment
Aciclovir….3.0% w/w
Type of Form Form-5
Finished Product Specification Firm asks for the USP specification but no data present in USP
as Acyclovir eye ointment
Pack size & Demanded Price 4.5g /As per SRO
Approval status of product in Reference Zovirax (Aciclovir) 3.0% | Ointment;Ophthalmic|
Me-too status Not present as per available DRAP Database
Brand Name +Dosage Form + Strength METAPRED eye ointment
Prednisolone acetate….0.2% w/w
Sulphacetamide Sodium ….10%w/w
Pharmacological Group Corticosteroid + Antibiotic
Type of Form Form-5
Approval status of product in Reference BLEPHAMIDE S.O.P. (Prednisolone Acetate 0.2%;
Regulatory Authorities. Sulfacetamide sodium 10%) (MHRA Approved)
Me-too status Blephnil Eye Ointment, Innvotek Pharmaceuticals (Pvt) Ltd.,
Reg.# 081635
Decision: Approved.
Brand Name +Dosage Form + Strength OXYPOL Ophthalmic ointment
Oxytetracyclin….5mg
Polymyxin B Sulphate ….10,000 units
Pharmacological Group Antibiotics
Type of Form Form-5
Approval status of product in Reference Terramycin W/ Polymyxin B Sulfate (Eq 5mg Base/Gm;10,000
Regulatory Authorities. Units/Gm)US-FDA Approved.
Me-too status Germoxy eye ointment by Valor pharma, ISB
Reg.# 074807
Decision: Approved.
Brand Name +Dosage Form + Strength FELONEye ointment.
Composition Each gram contains: - Fluorometholone….0.1%w/w
Type of Form Form-5
Approval status of product in Reference FML Fluorometholone (0.1%)
Regulatory Authorities. (US-FDA Approved)
Me-too status Eyfem Ophthalmic Ointment; Reg#023766
Decision: Approved.
Brand Name +Dosage Form + Strength HIFAXeye ointment
Polymyxin B Sulphate...10,000 units
Zinc Bacitracin………. 500 units
Type of Form Form-5
Approval status of product in Reference POLYFAX Polymyxin B Sulphate 10,000 units + Zinc
Regulatory Authorities. Bacitracin 500 units (MHRA Approved)
Me-too status POLYFAX Polymyxin B Sulphate 10,000 units + Zinc
Bacitracin 500 units. Reg.#000372
Decision: Approved.
698. Name and address of manufacturer M/s Jaens Pharmaceutical Industries (Pvt) Ltd, 28-km
Sheikhupura Road, Lahore.
Brand Name +Dosage Form + Strength DICIP Eye ointment
Ciprofloxacin HCl….3mg (0.3%)
Type of Form Form-5
Approval status of product in Reference CILOXAN (Ciprofloxacin HCl 3.0mg/g Eye Ointment)
Me-too status Quinocip Eye Ointment 0.3%
by M/s Vega Pharma. Reg.# 069170
Decision: Approved.
Brand Name +Dosage Form + Strength BYMIN-HOphthalmic ointment
(Polymyxin B Sulphate 10,000 units + Zinc Bacitracin 500
units + Neomycin 3.5mg + Hydrocortisone 1%)
Type of Form Form-5
Finished Product Specification Innovator specs.
Approval status of product in Reference Cortisporin (400 Units/Gm;1%;Eq 3.5mg Base/Gm;10,000
Regulatory Authorities. Units/Gm)US-FDA Approved
Me-too status Not present as per available DRAP Database
Decision: Approved.
Evaluator PEC-VI
th th
CLB in its 259 meeting held on 29 and 30 March 2018, has approved the following 3 additional sections of M/s
Medisure Laboratories Pakistan.
a) Capsule (Cephalosporin)
b) Dry Powder Suspension(Cephalosporin)
c) Dry Powder Injection(Cephalosporin)Section
Sterile dry powder Injection (Cepahlosporin) section: 9 Products/ 3 Molecules

700. Name and address of manufacturer / M/s Medisure Laboratories Pakistan Pvt Ltd.
Applicant
Brand Name +Dosage Form + Strength Armasure 1gm IV Injection
Ceftriaxone as sodium….1gm
Type of Form Form-5
rd
296
GMP status New-Section
Decision: Deferred for confirmation whether the applied product is already registered with the
applicant (contract manufacturing) or otherwise.
Applicant
Brand Name +Dosage Form + Strength Armasure 500mg IV Injection
Ceftriaxone as sodium….500mg
Type of Form Form-5
Applicant
Brand Name +Dosage Form + Strength Armasure 250mg IV Injection
Ceftriaxone as sodium….250mg
Type of Form Form-5
Applicant
Brand Name +Dosage Form + Strength Ceftin 750mg Injection
Cefuroxime as sodium….750mg
Type of Form Form-5
Approval status of product in Reference Cefuroxime 750 mg powder for solution for injection by M/s
Regulatory Authorities. MIP Pharma GmbH (MHRA Approved)
Me-too status ZINACEF 750MG INJ by M/s GSK Pakistan (Reg#006222)
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Ceftin 250mg 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
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Suresef 2gm Injection
Cefotaxime as sodium….2gm
Type of Form Form-5
Approval status of product in Reference Claforan Injection 2gm by M/s Aventis Pharma Limited
Me-too status Claforan 2g Injection by M/s Sanofi Aventis (Reg.#076156)
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Suresef 1gm 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
Medicaid, Karachi (Reg#080279)
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Suresef 500mg 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
Applicant
Brand Name +Dosage Form + Strength Suresef 250mg Injection
Cefotaxime as sodium….250mg
Type of Form Form-5
Approval status of product in Reference Claforan Injection 250mg by M/s Aventis Pharma Limited
Decision: Approved
Capsule (Cephalosporin): 1 Products/ 1 Molecules
Applicant
Brand Name +Dosage Form + Strength Surexime 400mg capsule
Cefixime as cefixime trihydrate…..400mg
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)
Dry Powder Suspension (Cephalosporin): 1 Products/ 1 Molecules
Applicant
Brand Name +Dosage Form + Strength Surexime 100mg/5ml Suspension
Cefixime as cefixime trihydrate…..100mg
Type of Form Form-5
Pack size & Demanded Price 30ml, As per SRO
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)
Evaluator PEC-XII
Case. No. M/s Max Pharmaceuticals. Rawalpindi. (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 Max Pharmaceuticals. Accordingly, firm has applied for following products for
consideration by Drug Registration Board.
1 Dry powder for injection (Cephalosporin) 11 04
Dry powder for injection (Cephalosporin)
11 products / 04 molecules
711. Name and address of manufacturer / M/s Max Pharmaceuticals, Plot No. 12, Street No. N-7, National
Applicant Industrail Zone, Rawat. Rawalpindi.
Brand Name +Dosage Form + Strength C-Bactam Dry Powder Injection 500g
Diary No. Date of R& I & fee Diary No: 16881, 07-05-2018 , Rs: 20,000/-
Cefoperazone (as sodium)....250mg
Sulbactam (as sodium)....250mg
Pharmacological Group 3rd Generation Cephalosporin + Beta Lactamase Inhibitor
Type of Form Form-5
Approval status of product in PMDA Japan Approved
Me-too status Paratam injection 0.5gm. by M/s Al-Habib Corporation
(Reg#041156)
GMP status 15-02-2018; Grant of additional section (Cephalosporin Dry
powder injection),
Panel recommends Grant of additional section.
Decision: Approved.
Brand Name +Dosage Form + Strength C-Bactam 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 additional section (Cephalosporin Dry powder injection),
Decision: Approved.
Brand Name +Dosage Form + Strength M-Pime Dry Powder Injection 250mg
Composition Each Vial Contains:
Cefepime (as hydrochloride)…250mg
With L-Arginine
Pharmacological Group 4th Generation Cephalosporin
Type of Form Form-5
Approval status of product in Not confirmed.
Me-too status Cefstar Injection IV/IM 250mg by Barret Hodgson (Reg#
076005)
Remarks of the Evaluator.  Approval status of product in Reference Regulatory
Brand Name +Dosage Form + Strength M-Pime Dry Powder Injection 500mg
Cefepime (as hydrochloride)…500mg
With L-Arginine
Type of Form Form-5
Approval status of product in Cefipime hydrochloride 500mg Injection by M/s Hospira, Inc.
Reference Regulatory Authorities. (USFDA approved)
Me-too status Uspime 500mg Injection by Usawa Pharmaceuicals (Reg#
060251)
Decision: Approved.
Brand Name +Dosage Form + Strength M-Pime Dry Powder Injection 1 g
Cefepime (as hydrochloride)…1 gm
With L-Arginine
Type of Form Form-5
Approval status of product in Cefipime hydrochloride 1gm Injection by M/s Hospira, Inc.
Reference Regulatory Authorities. (USFDA approved)
Me-too status Uspime 500mg Injection by Usawa Pharmaceuicals (Reg#
060250)
Decision: Approved.
Brand Name +Dosage Form + Strength Ceftadim Dry Powder Injection 250mg
Ceftazidime (as pentahydrate)…250mg
Pharmacological Group 3rd Generation Cephalosporin
Type of Form Form-5
Approval status of product in Fortum 250 mg powder for solution for injection by M/s
Reference Regulatory Authorities. GlaxoSmithKline UK (MHRA Approved)
Me-too status Panacef Injection 250mg by M/s CCL (Reg# 023858)
Decision: Approved.
Ceftazidime (as pentahydrate)…500mg
Type of Form Form-5
Approval status of product in 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.
Ceftazidime (as pentahydrate)…1gm
Type of Form Form-5
Approval status of product in Fortum 1g powder for solution for injection by M/s
Me-too status Panacef Injection 1gm by M/s CCL (Reg# 023986)
Decision: Approved.
Brand Name +Dosage Form + Strength Cefomax Dry Powder Injection 250mg
Diary No. Date of R& I & fee Diary No: 16883, 07-05-2018, Rs: 20,000/-
Cefotaxime (as sodium)....250mg
Type of Form Form-5
Approval status of product in Claforan Injection 250mg by M/s Aventis Pharma Limited
Reference Regulatory Authorities. (MHRA Approved)
Decision: Approved.
Cefotaxime (as sodium)....500mg
Type of Form Form-5
Approval status of product in Claforan Injection 500mg by M/s Aventis Pharma Limited
Decision: Approved.
Cefotaxime (as sodium)....1gm
Type of Form Form-5
Approval status of product in Claforan Injection 1gm by M/s Aventis Pharma Limited (MHRA
Reference Regulatory Authorities. Approved)
Me-too status Getex Dry powder Injection 1gm by M/s Amarant from Medicaid,
Karachi (Reg#080279)
Decision: Approved.
Evaluator PEC-III
M/s Irza Pharma (Pvt) Ltd., 10.2 KM, Lahore Sheikhupura Road, Lahore
Following two additional sections of M/s Irza Pharma (Pvt) Ltd., 10.2 KM, Lahore Sheikhupura Road, Lahore
have been approved by Central Licensing Board in its 254th meeting. The letter for grant of additional sections
was issued to the firm on 4th October 2017.
1. Capsule section (Cephalosporin)
2. Oral dry powder suspension (Cephalosporin)
Now the firm has applied for following
1 Capsule section (Cephalosporin) 10 6
2 Oral dry powder suspension (Cephalosporin)
The section approval letter issued by Licensing division states as “On recommendations of panel of experts, the
Central Licensing Board in its 254th meeting held on 15th June, 2017 has considered and approved the expansion
of additional section / amendment of your firm M/s Irza Pharma (Pvt) Ltd”
The firm has also submitted panel inspection report dated 12-5-2017 concludes “Panel decided to recommend
the renewal of DML, panel also decided to recommend the grant of two additional sections to M/s Irza Pharma
(Pvt) Ltd., Lahore”
Capsule section (Cephalosporin): Products-10, Molecules-6
722. Name and address of manufacturer / M/s Irza Pharma (Pvt) Ltd., 10.2 KM, Lahore Sheikhupura
Brand Name +Dosage Form + Strength Cefix Capsule 200mg
Cefixime trihydrate eq. to cefixime……200mg
Pharmacological Group Cephalosporin antibiotic
Type of Form Form 5
Pack size & Demanded Price 1x10’s: Rs. 300/-
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
GMP status New section
Decision: Approved.
Brand Name +Dosage Form + Strength Cefix Capsule 400mg
Cefixime trihydrate eq. to cefixime……400mg
Type of Form Form 5
Pack size & Demanded Price 1x5’s: Rs. 375/-
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
Decision: Approved.
Brand Name +Dosage Form + Strength Lexin Capsule 250mg
Cephalexin monohydrate eq to cephalexin…..250mg
Type of Form Form 5
Approval status of product in Reference Cefalexin 250 mg Capsules, by Athlone Pharmaceuticals
Me-too status Xtab-250 Capsule by Wellborne
Decision: Approved.
Brand Name +Dosage Form + Strength Lexin Capsule 500mg
Cephalexin monohydrate eq to cephalexin…..500mg
Type of Form Form 5
Approval status of product in Reference Cefalexin 500 mg Capsules by Alkem Pharma GmbH (MHRA
Me-too status Ceporex 500mg Capsule by GSK
Decision: Approved.
Brand Name +Dosage Form + Strength Faclor Capsule 250mg
Cefaclor monohydrate eq to cefaclor (anhydrous)……250mg
Type of Form Form 5
Pack size & Demanded Price 12’s: Rs. 350.51/-
Approval status of product in Reference Cefaclor 250mg Capsules by Ranbaxy (UK) Limited (MHRA
Me-too status Faceclor 250mg Capsule by City Pharma
Decision: Approved.
Brand Name +Dosage Form + Strength Faclor 500mg Capsule
Cefaclor monohydrate eq to cefaclor (anhydrous)……500mg
Type of Form Form 5
Approval status of product in Reference Cefaclor Capsules 500mg by Strides Pharma UK Ltd (MHRA
Me-too status Faceclor 500mg Capsule by City Pharma
Decision: Approved.
Brand Name +Dosage Form + Strength Cefdine Capsule 250mg
Cephradine monohydrate eq to cephradine ….250mg
Type of Form Form 5
Pack size & Demanded Price 10’s: 103.79/-
Approval status of product in Reference Cefradine 250mg Capsules by Athlone Pharmaceuticals
Me-too status Zasinol 250mg capsule by Martin Dow
Decision: Approved.
Brand Name +Dosage Form + Strength Cefdine Capsule 500mg
Cephradine monohydrate eq to cephradine ….500mg
Type of Form Form 5
Pack size & Demanded Price 10’s: 003.88/-
Approval status of product in Reference Cefradine 500mg Capsules by Athlone Pharmaceuticals
Me-too status Dinar 500mg capsule by Baxter Pharma
Decision: Approved.
Brand Name +Dosage Form + Strength Cefura Capsule 250mg
Cefuroxime axetil eq to cefuroxime…..250mg
Type of Form Form 5
Me-too status Trucef capsule by synchro Pharma
Remarks of the Evaluator. Evidence of approval of applied formulation in reference
regulatory authorities could not be confirmed.
Brand Name +Dosage Form + Strength I-Drox Capsule 500mg
Cefadroxil monohydrate eq to cefadroxil…..500mg
Type of Form Form 5
Approval status of product in Reference Cefadroxil 500 mg capsules by Alkaloid-INT
Me-too status Evacef 500mg Capsules by Highnoon Pharma
Decision: Approved.
b. Remaining Molecule(s)
Evaluator PEC-II
Case. No. 1 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.
732. Name and address of manufacturer / M/s Hudson Pharma, D-93, North Western Industrial Zone,
Applicant Port Qasim Authority, Karachi
Brand Name +Dosage Form + Strength Brimoson Eye Drops 0.2%
Composition Each ml of solution contains:
Brimonidine as tartrate …… 2mg
Diary No. Date of R& I & fee Dy. No. 14618, 19-04-2018 , Rs.20,000/- (Photocopy challan)
Pharmacological Group Alpha-2 adrenergic receptor agonist
Type of Form Form-5
Me-too status Brimonidine Tartrate Ophthalmic Solution 0.2%. of M/s Ali
Gohar & Company (Pvt.) ltd., Karachi (Reg.# 044835)
GMP status Date of Inspection: 11-12-2017
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.
Decision: Approved
Evaluator PEC-V
M/s Pacific Pharmaceuticals (Pvt) Ltd, Lahore.
CLB in its 257th meeting held on 24th -25th January, 2018 has considered and granted additional section
to M/s Pacific Pharmaceuticals (Pvt) Ltd. Accordingly; firm has applied for following products for
consideration by Drug Registration Board
● Tablet (Hormone)
The details of already approved and deferred products in 281st meeting of Registration Board are as
under:
Sr. No. Name of section No. of molecules Deferred Remaining
already approved molecules molecules
1. Tablet (Hormone) Nil 8 1
733. Name and Address of Manufacturer / M/s Pacific Pharmaceuticals Ltd, 30-km, Multan Road,
Applicant Lahore.
Brand Name + Dosage Form + Strength Oncamide/Oncomide Tablets 50mg
Biclatumide… 50mg
Pharmacological Group Antineoplastic And Immunomodulating Agents
Anti-Androgens
ATC code L02BB03
Type of Form Form-5
Approval Status of Product in Reference COSUDEX bicalutamide 50mg tablet film coated by
Regulatory Authorities. AstraZeneca Pty Ltd (TGA Approved)
Me-too Status Casodex 50mg Tablet by ICI (Reg. No. 027380)
Decision: Deferred for clarification/justification for manufacturing of applied formulationin
Tablet (Hormone) section.
Evaluator PEC-XI
M/s. Aulton Pharmaceuticals, Hattar (Remaining products)
APPROVED APPROVED DEFFERED TOTAL
SECTIONS (Products / (Products+ (MOLECULES)
Molecules) Molecules)
1. Dry Powder suspension (cephalosporin) 2-P/ 1-M - 1
section
2. Dry Powder injection (cephalosporin) 14-P/ 5-M - 5
section
Now firm has applied for following products detailed as under
Dry Powder suspension (cephalosporin) section
01-P/ 01-M
734. Name and address of manufacturer / M/s Aulton Pharmaceuticals, Plot # 84/1, Block A, Phase
Applicant 5, Industrial Estate, Hattar.
Brand Name +Dosage Form + Strength Derfado dry suspension 250mg/5ml
Cefadroxil (as monohydrate)…250mg
Diary No. Date of R& I & fee Dy. No. 4635, 08-02-2018, Rs.20,000/-
Type of Form Form-5
Pack size & Demanded Price 60ml; As per PRC
Me-too status (with strength and dosage Oxibac 250mg/5ml Dry powder Suspension of M/s UDL
form)
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.
Decision: Approved.
Dry Powder injection (cephalosporin) section
02-P/ 01-M
Brand Name +Dosage Form + Strength Zida injection 250mg
Ceftazidime (as pentahydrate)………… 250mg
Type of Form Form-5
Me-too status (with strength and dosage Biozid injection 250mg of M/s Bio-Labs (Pvt.) Ltd.
form)
Remarks of the Evaluator  Firm has revised salt from Ceftazidime (as sodium) to
Ceftazidime (as pentahydrate) and submitted fee of Rs.
5,000/- for revision of formulation vide deposit slip No.
0620874, dated 08-06-2018.
Decision: Approved.
Brand Name +Dosage Form + Strength Zida injection 1gm
Ceftazidime (as pentahydrate)…………1gm
Type of Form Form-5
Me-too status (with strength and dosage Biozid injection 1gm of M/s Bio-Labs (Pvt.) Ltd.
form)
Remarks of the Evaluator Firm has revised salt from Ceftazidime (as sodium) to
Ceftazidime (as pentahydrate) and submitted fee of Rs. 5,000/-
for revision of formulation vide deposit slip No. 0620875, dated
08-06-2018.
Decision: Approved.
Evaluator PEC-XI
Case No. M/s Well & Well Pharma (Pvt.) Ltd., Islamabad. (Remaining products)
The Central Licencing Board in its 254th meeting has granted approval of following additional sections to M/s
Well & well Pharma (Pvt) Ltd, Islamabad.
1. Dry powder for oral suspension (Cephalosporin)
2. Capsule (Cephalosporin)
Sr. Section No. of P/M already No. of No. of molecules
No. approved products
1 Capsule (Cephalosporin) Section 02-P/01-M 07 04
2 Dry powder suspension 02-P/01-M 08 04
(Cephalosporin) Section
Capsule (Cephalosporin) Section
05 Product/ 03 Molecule
737. Name and Address of Manufacturer / M/s Well & Well Pharma (Pvt.) Ltd., Plot No. 7, Street No. S-
Brand Name + Dosage Form + Strength C-Lex capsule 500mg
Cephalexin (as monohydrate)…………….500mg
Diary No. Date of R & I & fee Dy. No.17205; 09-05-2018; Rs.20,000/- (09-05-2018)
Type of Form Form-5
Pack Size & Demanded Price 1x12’s; Rs.102/- / As fixed by Govt.
Approval Status of Product in Reference Keflex (USFDA approved)
Me-too Status Ultroxil capsule 500mg of M/s Himont pharmaceuticals
GMP Status Last inspection conducted on 08-02-2018; firm is operating at
fair level of cGMP compliance.
Decision: Approved.
Brand Name + Dosage Form + Strength C-Lex capsule 250mg
Type of Form Form-5
Pack Size & Demanded Price 1x12’s; Rs.102/-
As fixed by Govt.
Approval Status of Product in Reference Keflex (USFDA approved)
Me-too Status Ultroxil capsule 250mg of M/s Himont pharmaceuticals
Decision: Approved.
Brand Name + Dosage Form + Strength Ceflor capsule 500mg
Cefaclor (as monohydrate)…………….500mg
Type of Form Form-5
As fixed by Govt.
Approval Status of Product in Reference USFDA approved
Me-too Status Cefalor capsule 500mg of M/s Bosch pharmaceuticals
Decision: Approved.
Brand Name + Dosage Form + Strength Ceflor capsule 250mg
Type of Form Form-5
As fixed by Govt.
Approval Status of Product in Reference USFDA approved
Me-too Status Cefalor capsule 250mg of M/s Bosch pharmaceuticals
Decision: Approved.
Brand Name + Dosage Form + Strength Cefdrox capsule 500mg
Cefadroxil (as monohydrate)…………….500mg
Type of Form Form-5
As fixed by Govt.
Approval Status of Product in Reference MHRA approved
Me-too Status Biodroxil capsule 250mg of M/s Bosch pharmaceuticals
Decision: Approved.
Dry powder suspension (Cephalosporin) Section
06 Product/ 03 Molecule
Brand Name + Dosage Form + Strength Ceflor dry suspension 250mg/5ml
Type of Form Form-5
Pack Size & Demanded Price 60ml; Rs.300/-
As fixed by Govt.
Approval Status of Product in Cefaclor 250mg/5ml Suspension by M/s Strides Pharma UK
Reference Regulatory Authorities. Ltd (MHRA approved)
Me-too Status Sac-Lor 250mg/5ml Dry Suspension by M/s Semos Pharma

(Reg#081618)
Decision: Approved.
Brand Name + Dosage Form + Strength Ceflor dry suspension 125mg/5ml
Type of Form Form-5
Pack Size & Demanded Price 60ml; Rs.161/-
As fixed by Govt.
Approval Status of Product in Cefaclor 125mg/5ml Suspension by M/s Strides Pharma UK
Reference Regulatory Authorities. Ltd (MHRA approved)
Me-too Status Sac-Lor 125mg/5ml Dry Suspension by M/s Semos Pharma
(Reg#081617)
Decision: Approved.
Brand Name + Dosage Form + Strength Cefdrox dry suspension 125mg/5ml
Type of Form Form-5
Pack Size & Demanded Price 60ml; Rs.161.64/-
As fixed by Govt.
Approval Status of Product in Reference ORACEFAL 125 mg / 5 ml powder for oral
Regulatory Authorities. suspension by M/s Bristol - Myers Squibb (ANSM
Approved)
Me-too Status Oxibac 125mg/5ml Dry powder Suspension of M/s UDL
Karachi.
Decision: Approved.
Brand Name + Dosage Form + Strength Cefdrox dry suspension 250mg/5ml
Type of Form Form-5
Pack Size & Demanded Price 60ml; Rs.261.80/- / As fixed by Govt.
Approval Status of Product in MHRA approved
Me-too Status Oxibac 250mg/5ml Dry powder Suspension of M/s
UDL Karachi.
Decision: Approved.
Brand Name + Dosage Form + Strength C-Lex dry suspension 250mg/5ml
Type of Form Form-5
Pack Size & Demanded Price 60ml; Rs.102.00/- / As fixed by Govt.
Approval Status of Product in USFDA approved
Me-too Status Vegzin 250mg/5ml dry powder suspension of M/s Vega
Pharmaceuticals
Decision: Approved.
Brand Name + Dosage Form + Strength C-Lex dry suspension 125mg/5ml
Type of Form Form-5
Pack Size & Demanded Price 60ml; Rs.51.00/-
As fixed by Govt.
Approval Status of Product in USFDA approved
Me-too Status Vegzin 125mg/5ml dry powder suspension of M/s Vega
Pharmaceuticals
Decision: Approved.
Evaluator PEC-VI
Capsule (Cephalosporin): 2 Products/ 1 Molecules
748. Name and address of manufacturer / M/s Well and Well Pharma, Rawat Islamabad
Applicant
Brand Name +Dosage Form + Strength Cephdin 250mg capsule
Cephradine monohydrate eq to cephradine ……250mg
Type of Form Form-5
Me-too status Zasinol 250mg capsule byM/s Martin Dow (Reg#080643)
GMP status 8-2-2018, Follow up
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Cephdin 500mg capsule
Type of Form Form-5
Me-too status Dinar 500mg capsule byM/s Baxter Pharma (Reg#084548)
Decision: Approved.
Dry powder for oral suspension (Cephalosporin): 2 Products/ 1 Molecules
Applicant
Brand Name +Dosage Form + Strength Cephdin 125mg/5ml Dry suspension
Type of Form Form-5
Approval status of product in Reference VELOSEF '125' of Apothecon (USFDA) “Discontinued”
Me-too status Velosef of GSK
authorities/agencies as adopted by Registration Board in its 275th meeting.
Applicant
Brand Name +Dosage Form + Strength Cephdin 250mg/5ml Dry suspension
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.
c. Deferred cases (Human)

Evaluator PEC-VIII
752. Name and address of Manufacturer / M/s Liven Pharmaceuticals 49km Multan Road, Lahore.
Applicant
Brand Name +Dosage Form +Strength Loragesic 0.324mg/ml Injection
Buprenorphine (as hydrochloride)… 0.324mg
Pharmacological Group Partial opioid agonist
Type of Form Form-5
Pack Size & Demanded Price 5’s(1ml) ; As per SRO
Approval status of product in Approved in MHRA
Me-too status Segesic Injection 0.3mg/ml of Saydon Pharmaceuticals
Industries.
GMP status New License (Issuance Date: 11th April, 2018)
Remarks of Evaluator Mention type of primary packaging material whether it is type I,
type II, type III, glass ampoule or vial.
Final volume of applied formulation.
Previous decision Registration Board in its 282nd meeting deferred the case for
following reasons:
 Clarification of formulation & submission of application
in-line with innovator product i.e. buprenorphine (as
hydrochloride)… 0.3mg/ml injection.
 Submission of fee for change in formulation.
Evaluation by PEC Now the applicant has submitted following;
Revised formulation in line with innovator product i.e.
buprenorphine (as hydrochloride)… 0.3mg/ml injection.
Fee challan of Rupee 20,000 dated 31-05-18 for revision of
formulation.
Decision: Approved with BP specifications.
753. Name and address of Manufacturer / M/s M/s Liven pharmaceuticals 49km Multan Road, Lahore.
Applicant
Brand Name +Dosage Form +Strength Pentazolive 30mg/ml Injection
Pentazocine … 30mg
Pharmacological Group Partial opioid agonist
Type of Form Form-5
Pack Size & Demanded Price 5’s,(1ml), ; As per SRO
Me-too status Omsis 30mg Injection of Sami
Clarify the salt form of API.
following reason:
Revised formulation in line with innovator product i.e.
pentazocine (as lactate)…30mg/ml injection approved by US-
FDA.
formulation.
Decision: Approved with BP specifications.
754. Name and address of Manufacturer / M/s M/s Liven pharmaceuticals 49km Multan Road, Lahore.
Applicant
Brand Name +Dosage Form +Strength Olam 1mg/ml Injection
Midazolam … 1mg
Pharmacological Group Benzodiazepines
Type of Form Form-5
Pack Size & Demanded Price 1’s ,5’s,10’s (5ml), ; As per SRO
Approval status of product in Approved in US-FDA but discontinued however it is mentioned
Reference Regulatory Authorities **Federal Register determination that product was not
discontinued or withdrawn for safety or efficacy reasons**
Me-too status Midaz 5mg/5ml Injection of sami
Clarify the salt form of API.
In reference agencies it is approved as midazolam as
hydrochloride 5mg/5ml injection
following reason:
 For submission of fee for change in formulation as the
applicant has revised the formulation from midazolam
1mg/ml to midazolam (as hydrochloride) 1mg/ml.
formulation.
Decision: Approved with USP Specifications.
755. Name and address of Manufacturer / M/s Liven pharmaceuticals 49km Multan Road, Lahore.
Applicant
Brand Name +Dosage Form +Strength Fantalive 0.05mg/ml Injection
Fentanyl (as citrate) … 0.05mg
Pharmacological Group Narcotic analgesic
Type of Form Form-5
Pack Size & Demanded Price 5’s,(5ml), ; As per SRO
Approval status of product in Not verified
Me-too status Not verified in applied volume i.e. 5ml
Evidence of Me Too
Evidence of approval status of applied formulation in reference
agencies.
following reasons:
 Evidence of applied formulation/drug in applied volume
already approved by DRAP (generic / me-too status) along
with registration number, brand name and name of firm.
Evaluation by PEC Now the firm has submitted the following:
Approval status of applied formulation in TGA, reference product
is approved as 250mcg/5ml Injection.
Available me too products are in following volumes:
Fantol 500mcg/10ml injection of Uni-tech.
Fantol 100mcg/2ml injection of Uni-tech.
Decision: Registration Board deferred the case for further deliberation as reported generic product
has not been verified in applied filled volume i.e. 5ml.
Evaluator PEC-VI
756. Name and address of manufacturer / M/s Liven Pharmaceuticals, 49km Multan road, Lahore
Applicant
Brand Name +Dosage Form + Strength Esoproz 20mg capsule
Esomeprazole….20mg
Diary No. Date of R& I & fee Dy. No: 17363; 10-5-2018; Rs.20,000/- (10-5-2018)
Pharmacological Group Anti-Peptic Ulcerant
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s, 100’s As per SRO
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
GMP status New DML; 11-4-2018
Firm has Capsule (General) Section
Previous Decision: Decision of 282nd: Deferred for submission of correct
composition with salt form as per Reference product along with
correction fee.
Evaluation by PEC: Firm has now submitted as under:
Esomeprazole (As magnesium 3.H2O) pellets equivalent to
20mg of Esomeprazole.
Firm also deposited Rs.5,000/- vide Deposit slip No. 0782502
dated 31-5-2018
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Esoproz 40mg capsule
Esomeprazole….40mg
Pharmacological Group Anti-Peptic Ulcerant
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s, 100’s As per SRO
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
GMP status New DML; 11-4-2018
Firm has Capsule (General) Section
Previous Decision: Decision of 282nd: Deferred for submission of correct
composition with salt form as per Reference product along with
correction fee.
Esomeprazole (As magnesium 3.H2O) pellets equivalent to
40mg of Esomeprazole.
Firm also deposited Rs.5,000/- vide Deposit slip No. 0782507
dated 31-5-2018
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Flowmax 0.4mg capsule
Tamsulosin as HCl…..0.4mg
Pharmacological Group Alpha Blocker
Type of Form Form-5
Me-too status Uroflo capsule by Novartis
GMP status New DML; 11-4-2018. Firm has Capsule (General) Section
Remarks of the Evaluator. Pellets detail are not provided.
Previous Decision: Decision of 282nd: Deferred for source of pellets, along with
stability studies data, GMP certificate of supplier and
differential fee in case of import of pellets
Source of pellets for Tamsulosin is Vision Pharmaceuticals,
Islamabad.
GMP certificate of Vision Pharma is valid until 25-1-2019.
COA and stability data are provided.
759. Name
7 and address of manufacturer / M/s Searle Company Limited, 32km Multan road, Lahore
Applicant
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 tablet by
Regulatory Authorities. Southern Cross Pharma Pty Ltd (TGA Approved)
Me-too status Anastrozole 1mg Tablet by Novartis (Reg. No. 066179)
GMP status Last inspection report dated 8-2-2017: Panel confirms good
compliance to GMP
Previous Decision: Decision of 281st: Registration Board referred the case to QA
& LT Division to conduct GMP inspection of Firm on priority.
Evaluation by PEC: Firm has now submitted :
Certificate of GMP that is based on evaluation conducted on
28-2-2018 & 1-3-2018. Certificate is valid from one year from
the date of inspection.
Decision: Approved.
760. Name and address of manufacturer / M/s Searle Company Limited, 32km Multan road, Lahore
Applicant
Brand Name +Dosage Form + Strength Lexmara 2.5mg tablets
Letrozole…….2.5mg
Pharmacological Group Aromatase Inhibitor
Type of Form Form-5
Pack size & Demanded Price 2x10’s, As per DPC
rd
320
Approval status of product in Femara by Novartis(MHRA Approved)
Me-too status Femara by Novartis
compliance to GMP
Previous Decision: Decision of 281st: Registration Board referred the case to QA &
Certificate of GMP that is based on evaluation conducted on 28-
2-2018 & 1-3-2018. Certificate is valid from one year from the
date of inspection.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Co-Extor tablets 10mg/320mg/25mg
Amlodipine as besilyate…….10mg
Valsartan…..320mg
Hydrochlorothiazide……25mg
Type of Form Form-5
Pack size & Demanded Price As per DPC, As per DPC
Me-too status Exforge HCT 5mg/160mg/12.5mg of M/s Novartis,
Pakistan
compliance to GMP
Previous Decision: Decision of 281st: Registration Board referred the case to QA &
date of inspection.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Co-Extor tablets 10mg/160mg/25mg
Amlodipine as besilyate…….10mg
Valsartan…..160mg
Hydrochlorothiazide……25mg
Type of Form Form-5
Pack size & Demanded Price As per DPC, As per DPC
Me-too status Exforge HCT of M/s Novartis Pharma (Pak) Ltd
compliance to GMP
Previous Decision: Decision of 281st : Registration Board referred the case to QA &
date of inspection.
Decision: Approved.
Deferred Cases (Veterinary)
Evaluator PEC-XIV
Cases of M/s. Moreno Iglisias Research Laboratories (Pvt) Ltd., 21-KM, Ferozpur Road,
Lahore.
The CLB in its 248th meeting held on 13th July, 2016 has considered and approved the grant of two
additional sections of firm M/s. Moreno Iglisias Research Laboratories (Pvt) Ltd., Lahore (Drug
Manufacturing License No. 000478-formulation). The details of already approved and deferred cases are as
under:
Section Approved Deferred New Request of the firm
Applications
Veterinary Dry Powder The firm has requested to
3 (M-280) 7 (M-272) 6
(General Antibiotic) withdraw already deferred
Veterinary Dry powder products and replace with
2 (M-280) 8 (M-272) 6
(General) new applied products.
Veterinary Dry powder (General Antibiotic) (6molecules / 6products)

763. Name and address of manufacturer / M/s. Moreno Iglisias Research Laboratories (Pvt) Ltd.,
Applicant 21-KM, Ferozpur Road, Lahore.
Brand Name +Dosage Form + Strength AMANTA MORE Water Soluble Powder
Composition Each 100gm contains:-
Amantadine HCl…………………….10gm
Finished Product Specification In- house
Pack size & Demanded Price 100g, 500g, 1000g Sachet/Jar; Decontrolled
Me-too status ANTAMITS WSP of M/s. Wimits (Reg #078316)
GMP status At the time of inspection dated 12-12-2017, the different areas
of premises found clean and maintained. HVAC were also
installed in the sections and functional. No production activity
was observed at the time of inspection.
Remarks of the Evaluator.  Replacement of already deferred product “FUCOTYLE
Powder” in 272nd meeting
Brand Name +Dosage Form + Strength TF MORE Water Soluble Powder
Tylosin………………………..5g
Erythromycin…………………6g
Furaltadone………………….15gm
Pharmacological Group ANTIBIOTIC
Pack size & Demanded Price 100g, 500g, 1Kg, Box of 4 × 250g; Decontrolled
Me-too status ERY-TYLODON Oral Powder of M/s Nawal Pharma (Reg
#073968)
Remarks of the Evaluator.  Replacement of already deferred product “TD MORE Plus
Decision: Registration Board referred the case to Expert working group on Veterinary Drugs for
review of this formulation since it contains furaltadone.
Brand Name +Dosage Form + Strength CCN MORE Water Soluble Powder
Neomycin sulphate………………70gm
Colsitin sulphate………………….4gm
Chlortetracycline HCL…………..80gm
Bromhexine……………………………..5gm
Pharmacological Group Antibiotic and expectorant combination
Type of Form Form-5
Pack size & Demanded Price 100g, 500g, 1Kg, Box of 4 * 250g, Decontrolled
Me-too status Z-CNC-plus WSP of Zoic International (Reg#080943)
Remarks of the Evaluator.  Replacement of already deferred product “SPIRAMORE Plus
WSP” in 272nd meeting
Brand Name +Dosage Form + Strength MORENOTYLE PLUS Water Soluble Powder
Doxycycline HCL…………………….400gm
Tylosin Tartrate………………………200gm
Bromhexine HCL …………………….5gm
Type of Form Form-5
Me-too status TB-DOX POWDER of Attabak Pharma (Reg#075718)
Remarks of the Evaluator.  Replacement of already deferred product “OXYMOR CN
WSP” in 272nd meeting
Brand Name +Dosage Form + Strength FLOROX Water Soluble Powder
Composition Each gm contains:-
Florfenicol………………………150mg
Oxytetracycline HCL…………………….150mg
Type of Form Form-5
Me-too status Floxybar 30 WSP of Baariq Pharma (Reg# 072601)
Remarks of the Evaluator.  Replacement of already deferred product “T-D MORE
Brand Name +Dosage Form + Strength LEVAMORE Water Soluble Powder
Levamisole HCL…………………….200gm
Pharmacological Group Antiprotozoal
Type of Form Form-5
Pack size & Demanded Price 100g, 500g, 1000g Sachet/jar; Decontrolled
Me-too status LEFASTAR 20% of Star labs (Reg#081693)
Remarks of the Evaluator.  Replacement of already deferred product “TILCOMORE
Veterinary Dry Powder (General ) (6molecules / 6products)
Brand Name +Dosage Form + Strength TONER Water Soluble Powder
Ammonium Chloride…………………..30gm
Aspirin…………………………………10gm
Vitamin C…………………………….10gm
DL-Methionine…………………………….10gm
Vitamin A………………………………..150,000 IU
Sorbitol………………………………………5gm
Pharmacological Group Antibiotic / vitamins/ Amino Acids/Acidifier
Type of Form Form-5
Pack size & Demanded Price 100g, 500g, 1000g Sachet/jar; Decontrolled
Me-too status SCADA WSP of M/s Decent Pharma (Reg#079819)
Remarks of the Evaluator.  Replacement of already deferred product “HEPATOMOREN
Decision: Deferred for clarification regarding compatibility of vitamin C and Aspirin in applied
formulation.
Brand Name +Dosage Form + Strength RESPIMORE Water Soluble Powder
Lincomycin HCL…………………5gm
Spectinomycin HCL………………7gm
Spiramycin adipate……………….2.5gm
Bromhexine HCL………………...0.5gm
Type of Form Form-5
Me-too status SPECLINX Oral powder of Vantage Pharma (Reg#081714)
Remarks of the Evaluator.  Replacement of already deferred product MORENO MOX-C
Brand Name +Dosage Form + Strength TDC MORE Water Soluble Powder
Tylosin tartrate………………100g
Doxycycline HCL ………………….200gm
Colistin sulphate ………………..500MIU
Bromhexine HCL…………………….5gm
Type of Form Form-5
Me-too status D.G.Doxit WSP of BIOGEN PHARMA (Reg # 080147).
Remarks of the Evaluator.  Replacement of already deferred product “IMUREN Powder”
in 272nd meeting
Brand Name +Dosage Form + Strength MORENO COX Water Soluble Powder
Composition Each 1000g contains:-
Sulphaquinoxaline……………………..105gm
Diaverdine………………………………….28gm
Vitamin A…………………………………….5MIU
Vitamin K3…………..……………………2.5gm
Pharmacological Group Anticoccidial
Type of Form Form-5
Pack size & Demanded Price 100g, 500g, 1Kg, Sachet/Jar, Decontrolled
Me-too status Z-COX WSP of Zoic International (Reg#080944)
Remarks of the Evaluator.  Replacement of already deferred product “MORENOTHOL
Brand Name +Dosage Form + Strength C- LYTEMORE Water Soluble Powder
Vitamin C………………………….200gm
Acetyl salicylic acid…………………67gm
Calcium carbonate……………………50gm
Sodium chloride…………………………..40gm
Magnesium sulphate……………………..40gm
Sodium citrate…………………….0.5gm
Pharmacological Group Vitamin, Antipyretic and Electrolyte combination
Type of Form Form-5
Pack size & Demanded Price 100g, 500g, 1000g Jar containers made of HDPE Plastic;
Decontrolled
Me-too status COOLANT POWDER of Inshal Pharma (Reg#081721)
Remarks of the Evaluator.  Replacement of already deferred product “GARLIMORE
Powder” in 272nd meeting.
 The submitted me-too reference is of different strength.
Decision: Deferred for clarification regarding compatibility of vitamin C and Acetylsalisylic acid in
applied formulation.
Brand Name +Dosage Form + Strength NO TOX Water Soluble Powder
Methanamine………………..……….95gm
Vitamin B1…………………………800mg
Vitamin B2 ………………………..920mg
Vitamin K3…………………….200mg
Pharmacological Group Antiseptic/Diuretic vitamin Combination
Type of Form Form-5
Pack size & Demanded Price 100g, 500g, 1000 Sachet/Jar; Decontrolled
Me-too status CURTITOX oral powder of Decent Pharma (Reg#074057)
Remarks of the Evaluator.  Replacement of already deferred product “PS MORE Powder”
in 272nd meeting
Case No. 03: Registration applications for local manufacturing of (veterinary) drugs
a. New Cases
Evaluator PEC-XIV
775. Name and address of manufacturer / M/s. Inshal Pharmaceutical Industries, Plot # 2, Street SS2,
Applicant National Industrial Zone, Rawat Islamabad.
Brand Name +Dosage Form + Strength GENTYL INJECTION
Flunixin Meglumine……………..50mg
Diary No. Date of R& I & fee 18, 02-8-2012, Rs.12,000/-, 15-06-2015, 8000/-, (Photocopy
attached) 02-08-2012
Pharmacological Group Analgesic, antipyretic, Anti-inflammatory (NSAID)
Type of Form Form-5
Pack size & Demanded Price 50ml;Decontrolled
Me-too status MAXIN INJECTION of Alina Combine Pharma (Reg#043576)
GMP status Panel inspection conducted on 11-05-2018 recommended for the
renewal of DML and two additional sections
Brand Name +Dosage Form + Strength NOVAFIN FORTE INJECTION
Novaminsulfon…………..40mg
Etilefrin………………….0.2mg
Calcium Gluconate……..100mg
Magnessium Gluconate…..10mg
Sodium Salicylate…….…...7mg
Nicotinamide……………0.3mg
Boric Acid……………….10mg
Cafeine………………….10mg
Sodium Oxibenzyl Phosphoric Acid………..….5mg
Methyl parahydroxi benzoate………………….7mg
Sorbitol……………………………………….200mg
Pharmacological Group Immune booster, Multi Vitamin
Type of Form Form-5
Me-too status Biosign Injection of Genome Pharma
Decision: Registration Board rejected the application since applied formulation contains
Novaminsulfone (Metamizole) which is a banned drug.
Brand Name +Dosage Form + Strength AMOXILLIN INJECTION
Ceftiofur as HCl………………...50mg
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Me-too status CEFUR-RTU Injection of Nawan Laboratories
Remarks of the Evaluator.  The firm has submitted revised Form-5 with correct salt
form.
 The firm has not provided dedicated manufacturing facility
for Cephalosporin preparation.
Decision: Registration Board rejected the application since the firm has not provided dedicated
manufacturing facility for Cephalosporin preparation.
Brand Name +Dosage Form + Strength OXY LAG INJECTION
Oxytetracycline as Dihydrate..……….…200mg
Lidocaine Hydrochloride ……………….20mg
Pharmacological Group Antibacterial, Local Anesthetics
Type of Form Form-5
Me-too status Oxy-L20 injection of Attabak Pharma (Reg#034547)
Remarks of the Evaluator. The firm had initially applied following formulation:
Each ml contains:
Oxytetracycline Hydrochloride……….…200mg
Lidocaine Hydrochloride ……………….2mg
Now the firm has submitted revised Form-5 stating correct salt
form and strength of Lidocaine HCL as per me-too reference.
Brand Name +Dosage Form + Strength COLIFLOR INJECTION
Colistin Sulphate………….…60 MIU
Type of Form Form-5
Me-too status COLIBAK Injection of Attabak (Reg#053907)
letter.
Brand Name +Dosage Form + Strength BIOVICOM Injection
Toldimfos Sodium…………...…..100mg
Pharmacological Group General Therapeutics
Type of Form Form-5
Me-too status METAFOS Injection of Star Laboratories (Reg#027498)
letter.
Brand Name +Dosage Form + Strength NOVAVIT INJECTION
Oxytetracycline HCl……………..…100mg
Type of Form Form-5
Pack size & Demanded Price 50ml amber coloured glass vials;Decontrolled
Me-too status Oxy 10 Injection of M/s. Attabak Pharma (Reg#034548)
letter.
Brand Name +Dosage Form + Strength SPECTI LINK INJECTION
Doramectin………..……..10mg
Pharmacological Group Anthelmentic
Type of Form Form-5
Finished Product Specification In house specification
Me-too status DECTOMAX Injectable solution of Ghazi Brothers
(Reg#027479)
letter.
Brand Name +Dosage Form + Strength GENTAFATE Injection
Gentamycin Sulphate……….….5g
Tylosin Tartrate…………….….10g
Colistin Sulphate……………....50 MIU
Type of Form Form-5
Finished Product Specification In hosue specification
Pack size & Demanded Price 100ml Amber coloured glass vials;Decontrolled
Me-too status TG-65 Injection of Attabak pharma (Reg#071064)
Decision: Deferred for clarification of composition of applied formulation since quantities of APIs are
in grams per ml.
Brand Name +Dosage Form + Strength TYLO CS Injection
Mepyramine Maleate………….…..50mg
Pharmacological Group Anti-Histamine
Type of Form Form-5
Me-too status ALLERGINIL Liquid injection of Sanna Lab (Reg#069623)
review of this formulation.
Brand Name +Dosage Form + Strength DIATRIM Injection
Meloxicam……………....7.5mg
Pharmacological Group NSAIDs
Type of Form Form-5
Me-too status CAMILOX Injection of M/s Selmore pharma (Reg # 071089)
Brand Name +Dosage Form + Strength PREDNOMIN INJECTION
Prednisolone Acetate…………..…10mg
Chlorpheniramine Maleate……....…4mg
Pharmacological Group Anti-Histamine, Steroids
Type of Form Form-5
Me-too status SOLOMIN INJECTION of Selmore Pharma (Reg # 049642)
Remarks of the Evaluator.  Evidence of manufacturing facility for Liquid Injection
(Steroidal) section is required to be submitted.
Decision: Registration Board rejected the application since the firm does not have manufacturing
facility for Liquid Injection (Steroidal) section.
Brand Name +Dosage Form + Strength MINAPYRINE INJECTION
Diminazene Aceturate……..105mg
Antipyrine…..………….....131mg
Pharmacological Group Analgesic, Antipyretic, Antitrypansomiasis
Type of Form Form-5
Me-too status PRONIL INJECTION of Selmore Pharma (Reg # 029609)
review of this formulation.
Brand Name +Dosage Form + Strength IVOSHELL PLUS INJECTION
Ivermectin………….………20mg
Clorsulon………………….100mg
Type of Form Form-5
Me-too status Ivoron Super Injection of Breeze Pharma
Remarks of the Evaluator.  The submitted me-too reference is of different strength.
Brand Name +Dosage Form + Strength IVERIN Injection
Vitamin E……………..40mg
Vitamin A…………100,000 IU
Vitamin D3………….40,000 IU
Pharmacological Group Multivitamin
Type of Form Form-5
Me-too status ADEKA Injection of M/s. A & K Pharma (Reg# 075792)
letter.
Brand Name +Dosage Form + Strength AMCOLINE POWDER
Doxycycline HCL……..200g
Tylosin Tartrate……….100g
Amantadine HCL……………40g
Colistin Sulphate……..200 MIU
Pharmacological Group Antibacterial, Anti-viral, Expectorant
Type of Form Form-5
Pack size & Demanded Price 100g, 250g, 500g, 1Kg, 5Kg, 10Kg; Decontrolled
Me-too status TDCA Powder of Attabak Pharma (Reg#071070)
Decision: Deferred for rationale of amantadine in applied formulation.
Brand Name +Dosage Form + Strength NEO FENICOL POWDER
Neomycin Sulphate…..……..60mg
Oxytetracycline HCl……......200mg
Streptomycin Sulphate………20mg
Pharmacological Group Anti-infective, Antibacterial
Type of Form Form-5
Pack size & Demanded Price 100g, 125g, 250g, 500g, 1Kg, 2.5Kg; Decontrolled
Me-too status NEOSTREP POWDER of Attabak Pharma (Reg#075720)
letter.
Brand Name +Dosage Form + Strength COLAVERY POWDER
Frusemide…………..…….2g
Belladona Extract………..0.2g
Pharmacological Group Diuretic, Flusher
Type of Form Form-5
Pack size & Demanded Price 100g, 250g, 500g, 1Kg, 5Kg, 10Kg ; Decontrolled
Me-too status Bella Flush WSP of Attabak Pharma (Reg#075724)
Remarks of the Evaluator.  The firm has submitted revised Form-5 correcting strength of
Belladona Extract………..0.02g to Belladona
Extract…..0.2g as per me-too reference.
Brand Name +Dosage Form + Strength AMENTO TD Water Soluble Powder
Doxycycline HCI……………22g
Tylosin Tartrate…………….10g
Bromhexine HCI…………….1g
Amantadine HCI…………….4g
Pharmacological Group Antibacterial, Antiviral
Type of Form Form-5
Pack size & Demanded Price 100g, 250g, 500g, 1Kg, 5Kg, 10Kg ; Decontrolled
Me-too status DEBAT Powder of Leads Pharma (Reg#075731)
Remarks of the Evaluator.  The firm has submitted copy of registration letter for applied
formulation as me-too reference.
Brand Name +Dosage Form + Strength BENTA COL LIQUID
Norfloxacin………………..….20g
Colistin Sulphate……….…50 MIU
Type of Form Form-5
Pack size & Demanded Price 100ml, 150ml, 250ml, 500ml, 1Liter, 5Liter, 25Liter;
Decontrolled
Me-too status COLINOR Liquid of Attabak Pharma (Reg#071066)
letter.
Brand Name +Dosage Form + Strength COLISAMOX SUSPENSION
Triclobendazole……….50mg
Cobalt chloride……….1.67mg
Sodium Selenite………0.35mg
Type of Form Form-5
Pack size & Demanded Price 100ml, 150ml, 250ml, 450ml, 500ml, 1Liter, 2.5Liter;
Decontrolled
Me-too status TRICLOBAK S.C oral suspension of Attabak Pharma (Reg #
062166)
letter.
Brand Name +Dosage Form + Strength AMCOTET Water Soluble Powder
Doxycycline HCI…………..200g
Tylosin Tartrate………….…100g
Dihyrostreptomycin……...….20g
Bromhexine HCI…………….5g
Pharmacological Group Antibacterial, Anti-viral
Type of Form Form-5
Me-too status DOXYLO-S powder of Attabak Pharma (Reg # 075695)
letter.
Brand Name +Dosage Form + Strength COLAMOX Water Soluble Powder
Methenamine ……..……..85g
Vitamin B1…………..….700mg
Vitamin C…………….....100mg
Sorbitol……………….…5g
rd
336
Pharmacological Group Diuretic, Flusher
Type of Form Form-5
Pack size & Demanded Price 100g, 150g, 250g, 450g, 500g, 1Kg; Decontrolled
Me-too status URITOX POWDER of Attabak Pharma (Reg # 075722)
Remarks of the Evaluator.  The firm has mentioned sorbitol as active ingredient in the
master formulation.
Decision: Deferred for clarification regarding role of sorbitol in applied composition.
Brand Name +Dosage Form + Strength ANGO-FIN Liquid
Enrofloxacin…………….…200mg
Bromhexine HCI…………...10mg
Type of Form Form-5
Pack size & Demanded Price 100ml, 150ml, 250ml, 500ml, 1Liter; Decontrolled
Me-too status BROMOFLOX Liquid of Mylab (Reg # 073905)
Remarks of the Evaluator.  When the firm was communicated to provide rationale of
Acetic acid in formulation, the firm replied “Acetic acid is
fundamental to all forms of life when bound to co-enzyme A.
it is central to the metabolism of carbohydrates and fats. It is
best antiseptic from the formulation point of view”.
letter.
Brand Name +Dosage Form + Strength AMENTODOX Water Soluble Powder
Doxycycline HCI................200g
Tylosin Tartrate...................100g
Colistin Sulphate…………..500 MIU
Bromhexine HCI...................5g
Amantadine HCI…………...40g
Diary No. Date of R& I & fee Rs.12,000/-, 21-04-2015
Type of Form Form-5
Me-too status VIROX TD powder of Leads Pharma (Reg#075777)
Brand Name +Dosage Form + Strength AMOXYCOLIS Water Soluble Powder
Composition Each 100gm powder contains:-
Colistin Sulphate…………500,000,000 IU
Type of Form Form-5
Pack size & Demanded Price 100g, 250g, 500g, 1Kg, 5Kg, 10Kg, 25Kg; Decontrolled
Approval status of product in Reference Not provided by the firm.
Me-too status Colibak Fort powder of Attabak Pharma (Reg # 049784)
Remarks of the Evaluator.  The firm has submitted revised Form-5 after correcting the
IUs of Colistin sulphate as per me-too reference.
Brand Name +Dosage Form + Strength T D SHELL Water Soluble Powder
Doxycycline HCL.................200g
Tylosin Tartrate...................100g
Bromhexine HCL...................5g
Pharmacological Group Antibacterial, Expectorant
Type of Form Form-5
Me-too status TYDOXANE CP WSP of Cherished Pharma (Reg#057082)
letter
Brand Name +Dosage Form + Strength AMENTO SHELL SUSPENSION
Oxyclozanide…………46.875mg
Oxfendazole………..…16.9875mg
Pharmacological Group Anthelmintic
Type of Form Form-5
Pack size & Demanded Price 100ml, 150ml, 250ml, 450ml, 500ml, 1Lit, 2.5Lit; Decontrolled
Me-too status CLOZANIDE SUSPENSION of Attabak Pharma (Reg #
049774)
renewal of DML and two additional sections.
letter
Brand Name +Dosage Form + Strength NEWENT Liquid
Frusemide……………………….2g
Belladona Extract……….…...0.2g
Type of Form Form-5
Finished Product Specification In house specifications
Pack size & Demanded Price 100ml, 250ml, 500ml, 1Lit, 2.5Lit, 5Lit; Decontrolled
Me-too status FRUSIN-B Oral Liquid of Attabak Pharma (Reg # 062150)
Remarks of the Evaluator.  The firm has submitted revised Form-5 correcting the
strength of Belladonna extract as per me-too reference.
Brand Name +Dosage Form + Strength FLOROMYCIN Water Soluble Powder
Neomycin Sulphate……..…200g
Oxytetracycline HCL……….200g
Colistin Sulphate………..…240 MIU
Pharmacological Group Anti-infective, Antibacterial
Type of Form Form-5
Pack size & Demanded Price 100g, 500g, 1Kg, 2.5Kg, 10Kg, 25Kg; Decontrolled
Me-too status OXYNO PLUS WSP of Attabak (Reg#075682)
letter.
Brand Name +Dosage Form + Strength FRUNCH SUSPENSION
Oxyclozanide………..…….62.5mg
Oxfendazole……………..…22.65mg
Cobalt as Sulphate..……...…1.67mg
Selenium as Sodium Selenite………...0.5mg
Type of Form Form-5
Me-too status CLOZAFEN SUSPENSION of Attabak Pharma (Reg # 062139)
letter.
Brand Name +Dosage Form + Strength AVICOC PLUS LIQUID
Triclobendazole……………..5%
Levamisole HCI…………….3.75%
Diary No. Date of R& I & fee 12, 02-08-2012, 12,000/-, (Photocopy attached) 21-04-2015,
8000/- (Photocopy attached) 02-08-2012
Type of Form Form-5
Finished Product Specification In house
Me-too status Triclobak suspension of Attabak Pharma (Reg # 049696)
Remarks of the Evaluator.  The firm has submitted revised Form-5 stating correct
strength of Levamisole HCL as per me-too reference.
Brand Name +Dosage Form + Strength SPIRA-LIN Liquid
Florfenicol………………..23gm
Colistin Sulphate…….…..50 MIU
Diary No. Date of R& I & fee 14, 02-08-2012, Rs.12,000/-, 21-04-2015, 8000/- (Photocopy
Type of Form Form-5
Pack size & Demanded Price 100ml, 500ml, 1Lit, 2.5Lit, 5Lit, 10Lit; Decontrolled
Me-too status FLOTIN Liquid of D-Maarson (Reg#072680)
letter.
Brand Name +Dosage Form + Strength ENROCAP Liquid
Composition Each 100ml contains: -
Enrofloxacin ……………..…10g
Colistin Sulphate………….55MIU
Bomhexine HCI………........0.5g
Type of Form Form-5
Finished Product Specification In house
Pack size & Demanded Price 100ml, 150ml, 250ml, 500ml, 1Lit; Decontrolled
Me-too status ENRO CB Liquid of M/s. D-Maarson Pharma (Reg # 074083)
letter.
Brand Name +Dosage Form + Strength ENROCOLT Liquid
Composition Each 100ml contains: -
Oxyclozanide……………...6.0%
Levamisole HCI…………..3.0%
Cobalt Sulphate…………...0.05%
Type of Form Form-5
Me-too status NILZA MAR Super DS suspension of Attabak Pharma (Reg #
063834)
letter.
Brand Name +Dosage Form + Strength TRIMO SULF LIQUID
Florfenicol……..………...10gm
Colistin Sulphate……….…50 MIU
Type of Form Form-5
Finished Product Specification In-house specification
Pack size & Demanded Price 100ml, 500ml, 1Lit, 2.5Lit, 5Lit, 10Lit; Decontrolled
Me-too status FLORO-C Oral Liquid of D-Maarson Pharma (Reg # 074079)
letter.
Brand Name +Dosage Form + Strength ENCOLIN Liquid
Enrofloxacin…….…..……20g
Colistin Sulphate……..…..50 MIU
Type of Form Form-5
Me-too status COL-EN 70 Liquid of Attabak Pharma (Reg # 075691)
letter.
Brand Name +Dosage Form + Strength FLOXITIN Suspension
Oxyclozanide…………3.4%
Type of Form Form-5
Me-too status CLOZAK suspension of Attabak Pharma (Reg # 053911)
letter.
Brand Name +Dosage Form + Strength NEOCOLOXIN-T Water Soluble Powder
Frusemide…………..………25g
Sodium Chloride……..…….35g
Magnesium Sulphate….…...35g
Calcium Carbonate……..…..45g
Potassium Chloride………...4g
Manganese Sulphate….........1g
Type of Form Form-5
Pack size & Demanded Price 100g, 150g, 250g, 500g, 1Kg, 10kg, 25Kg; Decontrolled
Me-too status FRUSA SUPER WSP of Attabak Pharma (Reg # 075726)
letter.
Brand Name +Dosage Form + Strength NEOFLOR POWDER
Neomycin Sulphate……….…….70g
Type of Form Form-5
Pack size & Demanded Price 100g, 150g, 250g, 500g, 1Kg, 2.5kg; Decontrolled
Me-too status NEOMYCIN 70% powder of Attabak Pharma (Reg # 075694)
letter.
Brand Name +Dosage Form + Strength CENOTRIM LIQUID
Diary No. Date of R& I & fee 216, 05-12-2014, Rs.20,000/-, 04-12-2014,
Cenoxine………………….…..….75.0mg
Sulphamethoxypyridazine………..75.0mg
Sulphamethazine………………….50.0mg
Trimethoprim…………………….25.0mg
Pharmacological Group Antibacterial, Anticoccidial, Bronchodilator
Type of Form Form-5
Pack size & Demanded Price 50ml, 100ml, 200ml, 250ml, 500ml, 1lit, 5lit, 10lit Plastic Jars;
Decontrolled
Me-too status JFCINA oral solution of Jfrin Pharma (Reg#039993)
letter.
Brand Name +Dosage Form + Strength COLIXEN POWDER
Composition Each gm powder contains:-
Lincomycin HCI……..…..……100mg
Colistin Sulphate…………....…8,00,000IU
Type of Form Form-5
Finished Product Specification Manufacturer’s specs
Pack size & Demanded Price 100g, 250g, 500g, 1Kg, 5Kg Plastic Jars; Decontrolled
Me-too status E1-LINCOLIS powder of Elko organization (Reg#025377)
GMP status Panel inspection conducted on 11-05-2018 recommended for
the renewal of DML and two additional sections
letter.
Brand Name +Dosage Form + Strength GENTA B PLUS INJECTION
Diary No. Date of R& I & fee Each 100ml contains:-
Gentamycin Sulphate eq. to Gentamycin…………….10gm
Composition 694, 26-6-2012, Rs.12,000/-, 01-06-2015, 8000/-, (Photocopy
Type of Form Form-5
Me-too status Gentabak 10% Injection of Attabak Pharma (Reg#034550)
the renewal of DML and two additional sections.
letter.
Brand Name +Dosage Form + Strength LINZI 4.4% Water Soluble Powder
Lincomycin HCI…………….4.4%
Type of Form Form-5
Finished Product Specification Manufacturer’s specs.
Pack size & Demanded Price 100g, 250g, 500g, 1Kg, 5Kg Plastic Jars ; Decontrolled
Me-too status LINCOS-P Powder of A & K Pharma (Reg#049667)
letter.
Brand Name +Dosage Form + Strength FOSFOTYL POWDER
Composition 173, 22-06-2011, Rs. 8000/- 22-06-2011, Rs.12,000/-, 04-12-
2014,
Diary No. Date of R& I & fee Each 100gm contains: -
Calcium Fosfomycin…………..20gm
Tylosin Tartrate………………..10gm
Fructose…………………………18gm
Sodium Phosphate……………..15gm
Magnesium Sulphate………….10gm
Type of Form Form-5
Pack size & Demanded Price 30g, 50g, 100g, 250g, 500g, 1Kg, 5Kg, 10Kg Plastic Jars;
Decontrolled
Me-too status FOSBAC Plus-T Powder of Tec-Man (Reg#039968)
the renewal of DML and two additional sections.
Remarks of the Evaluator. The firm had initially applied the formulation without
Fructose. Now the firm has submitted revised Form-5 as per
me-too reference.
Decision: Registration Board rejected the application since the firm has changed the formulation by
adding fructose as API.
Brand Name +Dosage Form + Strength OZONE PLUS Liquid
Composition 217, 05-12-2014, Rs.20,000/-, 04-12-2014,
Diary No. Date of R& I & fee Each ml contains:-
Doxycycline HCL………….…200mg
Tylosin Tartrate….…….……..100mg
Colistin Sulphate………..…...480000IU
Bromhexine HCL………..…..5mg
Pharmacological Group Antibacterial, Bronchodilator
Type of Form Form-5
Pack size & Demanded Price 30ml, 50ml, 100ml, 250ml, 500ml, 1lit, 5lit, 10lit Plastic Jars;
Decontrolled
Me-too status PULMOBAK liquid of Attabak Pharma (Reg#053915)
Decision: Approved with innovator’s specifications 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.
Brand Name +Dosage Form + Strength AVOMYIN PLUS POWDER
Doxycycline HCL…………...200g
Tylosin Tartrate…………….100g
Streptomycin Sulphate…..….36g
Bromhexine HCL………….....5g
Colistin Sulphate…………....450 MIU
Type of Form Form-5
Pack size & Demanded Price 100g, 250g, 500g, 1Kg, 5Kg, 10Kg, 25Kg; Decontrolled
Me-too status PULMODOX-S Powder of Attabak pharma (Reg #071069)
GMP status Panel inspection conducted on 11-05-2018 ecommended for the
letter
822. Name and address of manufacturer / M/s. S.J&G. Fazul Ellahi (Pvt.) Ltd. Karachi
Applicant
Brand Name +Dosage Form + Strength ALBEN-20 POWDER
Albendazole…………….200mg
Type of Form Form-5
Pack size & Demanded Price 5g; Decontrolled
Me-too status ZOBEN 20 WSP of Prix Pharma (Reg#043285)
GMP status Panel Inspection dated 02-05-2018 concluded that panel was
satisfied for the improvements undertaken by the firm to comply
with the observations dated 12-07-2017.
823. Name and address of manufacturer / M/s. Selmore Pharmaceuticals (Pvt.) Ltd, 36 Km, Multan Road,
Applicant Lahore
Brand Name +Dosage Form + Strength VIRODINE Oral Powder
Amantadine hydrochloride…………100mg
Pharmacological Group Anti-viral
Type of Form Form-5
Pack size & Demanded Price 500gm, 1Kg, 2.5Kg, 5Kg; Decontrolled
Me-too status ANTAMITS WSP of Wimits Pharma (Reg#078316)
GMP status Panel inspection conducted on 02-01-2018 & 16-01-2018, the
firm was granted GMP certificate.
Evaluator PEC-III
824. Name and address of manufacturer/ M/s Sanna Laboratories, 1019-B, P.S.I.E Sargodha Road,
Brand Name+ dosage Form+ Strength Senrox-Excel Oral Liquid
Enrofloxacin…….250g
Colistin sulphate……50,000,000 IU
Diary No. Date of R&I & fee Dy No. 8224: 11-07-2017 PKR 20,000/-: 10-7-2017
Type of Form Form 5
Pack size & Demanded price 100ml, 250ml, 500ml, 1L, 5L: Decontrolled
Approval status of product in NA
Me-too status Vitaflox by Vetz Pharma
GMP status Panel inspection report conducted on 04-07-2017 for grant of
GMP certificate concluding fair level of compliance with GMP
guidelines.
rd
347
825. Name and address of manufacturer/ M/s Sanna Laboratories, 1019-B, P.S.I.E Sargodha Road,
Brand Name+ dosage Form+ Strength NCF-200 Oral water soluble powder
Composition Each 100g contains:
Neomycin as sulphate…….12g
Chlortetracycline HCl……40g
Furaltadone HCl………..30g
Type of Form Form 5
Pack size & Demanded price 100g, 300g, 500g, 1Kg, 5Kg, 10Kg, 25Kg: Decontrolled
Me-too status N.C. Bak by Attabak Pharma
GMP status Panel inspection report conducted on 04-07-2017 for grant of
GMP certificate concluding fair level of compliance with GMP
guidelines.
review of this formulation since it contains furaltadone.
826. Name and address of manufacturer/ M/s Farm Aid Group, Plot # 3/2, Phase-I & II, Hattar Industrial
Applicant Estate, Haripur
Brand Name+ dosage Form+ Strength Fagofol Liquid
Florfenicol……250mg
Type of Form Form 5
Finished Product Specification Firm has claimed Innovator’s specification
Pack size & Demanded price 50ml, 100ml, 200ml, 250ml, 500ml, 1L, 2.5L, 5L, 10L, 15L,
20L, 25L: Decontrolled
Me-too status Florfencol oral liquid by Attabak Pharma
compliance to GMP
Brand Name+ dosage Form+ Strength Floro CS Liquid
Florfenicol……..25g
Colistin sulphate………50MIU
Type of Form Form 5
Me-too status Flocol Liquid by D-Maarson Pharma
compliance to GMP
Brand Name+ dosage Form+ Strength Floro Aid Liquid
Florfenicol……….100mg
Type of Form Form 5
Me-too status Florfenicol oral solution by Star Laboratories
compliance to GMP
Remarks of the Evaluator. .
Evaluator PEC-VII
829. Name and address of Manufacturer / Intervac (Pvt) Ltd., 18 Km Lahore Sheikhupura Road,
Applicant Sheikhupura.
Brand Name+ Dosage Form+ Strength Ceftifas injection
Ceftiofur HCl (eq to Ceftiofur)…………..50 mg
Diary No. Date of R&I & fee Dy No.325 ; 25-04-2017; Rs.20,000/-
Type of Form Form-5
Pack Size & Demanded Price 100 ml glass vial
Decontrolled
Approval status of product in Reference EXCENEL® RTU EZ (USFDA)
Me-too status Cefur RTU injection of Nawan Labs (Reg # 049605)
the report concludes renewal of injection and vaccine
section.
Remarks of Evaluator GMP is older in 1 year
Decision: Registration Board referred the case to QA & LT Division to conduct GMP
inspection of Firm on priority.
Evaluator PEC-IV
830. Name and address of manufacturer / M/S Hawk Bio Pharma (Pvt) Ltd. Plot # 10 Street # S-6,
Applicant National Industrial Estate, RCCI, Rawat, Rawalpindi
Brand Name +Dosage Form + Strength POLIFLOX ORAL LIQUID
Enrofloxacin……….10gm
Colistin Sulphate………50,000,000 I.U
Type of Form Form 5
Pack size & Demanded Price 100ml, 500ml, 1000ml, 2.5Liter ; Decontrolled
Approval status of product in N/A
Me-too status (with strength and Ec-Tone Solution . M/s Guyton Pharmaceuticals,
dosage form)
report concludes that firm is found GMP complying.
Brand Name +Dosage Form + Strength COLIPOL-D ORAL LIQUID
Tylosin Tartrate……….14gm
Doxycycline HCl……..16gm
Colistin Sulphate………120M. I.U
Type of Form Form 5
Pack size & Demanded Price 100ml, 500ml, 1000ml,; Decontrolled
Me-too status (with strength and I-Tylodox-C Oral Solution Of M/S International Pharma
dosage form) Labs
GMP status Last GMP inspection conducted on 17-05-2018 ,and
the report concludes that firm is found GMP complying
Brand Name +Dosage Form + Strength TYFLOCOL ORAL LIQUID
Florfenicol……….10gm
Colistin Sulphate………50M. I.U
Type of Form Form 5
Pack size & Demanded Price 100ml, 500ml, 1000ml, 2.5Liter; Decontrolled
Me-too status (with strength and Florobex-C Liquid Of M/S Elegance Pharmaceuticals,
dosage form)
report concludes that firm is found GMP complying .
Brand Name +Dosage Form + Strength POLENRO-10 ORAL LIQUID
Colistin Sulphate………55 M.I.U
Bromhexine HCl……0.5gm
Type of Form Form 5
Me-too status (with strength and Enro Cb Liquid Of M/S. D-Maarson Pharmaceuticals,
dosage form)
report concludes that firm is found GMP complying
834. Name
1 and address of manufacturer / M/S Hawk Bio Pharma (Pvt) Ltd. Plot # 10 Street # S-6,
Brand Name +Dosage Form + Strength COLINOR -20 ORAL LIQUID
Colistin Sulphate………50 M.I.U
Type of Form Form 5
Me-too status (with strength and Floxa-C Oral Solution.Of M/Baariq Pharmaceuticals
dosage form)
835. Name
1 and address of manufacturer / M/S Inshal Pharmaceuticals, Plot # 2 Street Ss 2
Brand Name +Dosage Form + Strength AMENTA POWER POWDER
Composition Each 100gm powder contains:
Amantadine HCl……….10gm
Pharmacological Group Anti-Viral, Anti parkinsonism
Type of Form Form 5
Pack size & Demanded Price 100g, 250g, 500g, 1Kg, 5Kg, 10Kg, 25Kg ; Decontrolled
Me-too status (with strength and Amantabak 10% Powder .Of M/ Attabak
GMP status Last inspection conducted on 11-05-2018 for renewal of
DML and panel recommend the renewal of DML and over
all evaluation of inspection report is Rated as Good.and the
836. Name
Brand Name +Dosage Form + Strength PROVIT-M ORAL POWDER
Composition Each 1000 grams contains:
Vitamin A……….0.5 MIU
Vitamin D3………0.08 MIU
Vitamin E…………0.3gm
Calcium………..225.00gm
Phosphorus……….120gm
Magnesium……….25gm
Sodium…………20gm
Iron (As Ferrous)………1gm
Zinc……..3gm
Manganese………2gm
Copper………0.6gm
Cobalt………0.01gm
Iodine………0.02gm
Selenium……..0.003gm
Duplicate dossier
Pharmacological Group Vitamins/Mineral
Type of Form Form 5
Pack size & Demanded Price 500gm, 1000gm, 5Kg, 20Kg ; Decontrolled
Me-too status (with strength and Ade Minerals M/S Nawan Laboratories ,
dosage form)
Decision: Approved with change of brand name & 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.
837. Name
Brand Name +Dosage Form + Strength HYPERTONE MINERAL POWDER
Composition Each 1Kg contains:
VITAMIN D…100,000 I.U
VITAMIN E….300 I.U
IRON (AS FERROUS) 1000MG
COBALT….15MG
COPPER….600MG
IODINE….400MG
MENGANESE….2000MG
SELENIUM….3MG
SODIUM4.5%
MAGNESIUM…5.5%
CALCIUM…15.5%
PHOSPHORUS…14.2%
Duplicate dossier
Pharmacological Group Vitamins/Mineral
Type of Form Form 5
Pack size & Demanded Price 500gm, 1000gm, 5Kg, 20Kg, 25Kg ; Decontrolled
Me-too status (with strength and Vito Mineral-T Powder M/S Vital Mark
dosage form) Labs
Brand Name +Dosage Form + Strength BONE PHOSPHATE POWDER
Composition Each 1Kg contains:
CALCIUM……… 155GM
PHOSPHOROUS………… 135GM
MAGNESIUM……….. 55GM
SODIUM………….. 45GM
IRON (AS FERROUS)…………. 1GM
ZINC………….. 3GM
MAGANESE…………… 2GM
COPPER…………….. 0.6GM
COBALT……………. 0.01GM
IODINE…………. 0.04GM
Duplicate dossier
Pharmacological Group Macro & Mineral Mineral premix
Type of Form Form 5
Pack size & Demanded Price 500gm, 1000gm, 5Kg, 20Kg, 25Kg ; Decontrolled
Me-too status (with strength and L.S.Minerals Powder M/S Nawan Labs
dosage form)
839. Name
1 and address of manufacturer / M/S Sanna Laboratories, 1019-B, P.S.I.E Sargodha
Applicant Road, Faisalabad
Brand Name +Dosage Form + Strength Broncodox-300 Oral W/S Powder
Tylosin tartrate ……….100gm
Doxycycline HCl………200gm
Colistin Sulphate…….400 MIU
Bromhexine HCl…….3gm
Type of Form Form 5
Finished product Specifications Manufacturer’s Specification
Pack size & Demanded Price 100gm; 300g; 500g; 1 Kg; 5 Kg; 10Kg, 25Kg
Decontrolled
Me-too status (with strength and Bromodox-T Water Soluble Powderof M/S Attabak
dosage form) Pharma,
report concludes that firm was considered at fair level of
GMP compliance.
840. Name
1 and address of manufacturer / M/S Sanna Laboratories, 1019-B, P.S.I.E Sargodha
Applicant Road, Faisalabad
Brand Name +Dosage Form + Strength Saflor- Forte Oral Liquid
Composition Each 100ml powder contains:
Florfenicol……….25gm
Colistin Sulphate…….50 MIU
Type of Form Form 5
Finished product Specifications Manufacturer’s Specification
Pack size & Demanded Price 100ml; 250ml; 500ml; 1 Liter; 2.5 Liter; Decontrolled
Me-too status (with strength and Flocol Liquid Of M/S D-Maarson Pharmaceuticals,
dosage form)
report concludes that firm was considered at fair level of
GMP compliance.
841. Name
1 and address of manufacturer / M/S Leads Pharma (Pvt) Ltd,., 81-A, Street #6, I-
Applicant 10/3, Islamabad.
Brand Name +Dosage Form + Strength Noxystrep POWDER
Composition Each gm powder contains:
Neomycin Sulphate……….60mg
Oxytetracycline HCl………200mg
Streptomycin Sulphate………20mg
Type of Form Form 5
Pack size & Demanded Price 100g, 250g, 500g, 1000g, 2.5Kg, 5Kg, ; Decontrolled
Me-too status (with strength and Neostrep Powder.Of M/S. Attabak Pharmaceuticals,
dosage form)
GMP status Last GMP inspection is conducted on 17- 06- 2017 and
the report concludes that firm was found to be operating at
842. Name
1 and address of manufacturer / M/S Leads Pharma (Pvt) Ltd., 81-A, Street #6, I-
Applicant 10/3, Islamabad.
Brand Name +Dosage Form + Strength Ave Hexin POWDER
Bromhexine HCl……….5gm
Pharmacological Group Expectorant/Mucolytic agent
Type of Form Form 5
Pack size & Demanded Price 100g, 250g, 500g, 1Kg, 2.5Kg, 5Kg, ; Decontrolled
Me-too status (with strength and Bromex Water Soluble Powder of M/S. Attabak
dosage form) Pharmaceuticals,
GMP status Last GMP inspection is conducted on 17- 06- 2017 and
the report concludes that firm was found to be operating at
Case No. 04: Registration applications of categories to be considered on priority
Evaluator PEC-II
843. Name and address of manufacturer / M/s Medicraft Pharmaceuticals Pvt Ltd, 126-B, Industrial
Applicant Estate Jamrud Road, Peshawar.
Brand Name +Dosage Form + Strength Zolpimed 10mg Tablet
Composition Each Tablet Contains:
Zolpidem tartrate …… 10 mg
Diary No. Date of R& I & fee Dy.No 19044 dated 25-10-2017 Rs.20,000/- 25-10-2017
Pharmacological Group Hypnotic
Type of Form Form-5
Pack size & Demanded Price 2 x 10’s
Me-too status Olida 10mg Tablets of M/s Glitz Pharmaceuticals, Islamabad
(Reg.# 081418)
GMP status Last GMP Inspection conducted on 30-1-2018 with
conclusive remarks of cGMP compliance.
Remarks of the Evaluator.  In contrary to reference product approved by USFDA &
MHRA of UK, which is available as film coated tablet,
you have applied for uncoated tablet. Clarification shall
be submit in this regard.
 Upon communication of above cited observation firm
has submitted revised Form 5 & master formulation for
film coated tablets.
 Requisite fee for change of formulation has not been
submitted.
Decision: Deferred for submission of requisite fee for change of formulation.
844. Name and address of manufacturer / M/s Medicraft Pharmaceuticals Pvt Ltd, 126-B, Industrial
Applicant Estate Jamrud Road, Peshawar.
Brand Name +Dosage Form + Strength Letromed 2.5mg Tablet
Letrozole …… 2.5mg
Diary No. Date of R& I & fee Dy.No 19042 dated 25-10-2017 Rs.20,000/- Dated 25-10-
2017
Pharmacological Group Hormone antagonists and related agents (Aromatase
inhibitors)
Type of Form Form-5
Pack size & Demanded Price 10's
Approval status of product in Femara 2.5mg coated tablet by M/s Novartis
Reference Regulatory Authorities. Pharmaceuticals UK Ltd (MHRA Approved)
Me-too status Aromek Film Coated Tablets 2.5mg by M/s Glaxy Pharma
(Pvt) Ltd (Reg#052258)
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.
b. Local manufacturing applications of priority categories defined by Registration Board

in its 257th meeting
Evaluator PEC-I
845. Name and address of manufacturer M/s Genome Pharmaceutical (Pvt) Ltd,
Industrial area, Hattar, Haripur.
Brand Name +Dosage Form + Strength SUNIT Capsule 25 mg
Composition Each capsule contains: -
Sunitinib (as malate) 25mg
Pharmacological Group Anti-neoplastic (Cytotoxic)
Type of Form Form-5
Pack size & Demanded Price ---- / As per SRO
Approval status of product in Reference Sunitinib (as malate) 25mg Hard capsule,
Regulatory Authorities. MHRA & US-FDA approved.
Me-too status SUTENT Capsule 25 mg. (Reg#052226)
GMP status Copy of last GMP inspection report conducted on 12-05-2018,
concluding good level of cGMP compliance.
Decision: Defered for confirmation of required manufacturing facility for applied formulation.
Brand Name +Dosage Form + Strength SUNIT Capsule 12.5 mg
Sunitinib (as malate) 12.5mg
Type of Form Form-5
Approval status of product in Reference Sunitinib (as malate) 12.5mg Hard capsule,
Regulatory Authorities. MHRA & US-FDA approved.
Me-too status SUTENT Capsule 12.5 mg. (Reg#052225)
Decision: Defered for confirmation of required manufacturing facility for applied formulation
Brand Name +Dosage Form + Strength ERNOL Tablets 100mg
Composition Each tablet contains: -
Erlotinib as HCl…..100mg
Type of Form Form-5
Approval status of product in Reference TARCEVA (Erlotinib)100mg Tablets,
Regulatory Authorities. US-FDA approved.
Me-too status TARCEVA 150mg Tablets. (Reg#043002)
Brand Name +Dosage Form + Strength ERNOL Tablets 150mg
Erlotinib as HCl…..150mg
Type of Form Form-5
Approval status of product in Reference TARCEVA (Erlotinib)150mg Tablets,
Me-too status TARCEVA 150mg Tablets. (Reg#043003)
Brand Name +Dosage Form + Strength CERNIB Capsule 150 mg
Ceritinib…….150mg
Type of Form Form-5
Approval status of product in Reference Zykadia Ceritinib…..150mg capsule
Me-too status Not found as per available DRAP database
Brand Name +Dosage Form + Strength GEFNIB Tablet 250 mg
Gefitinib…….250mg
Type of Form Form-5
Approval status of product in Reference IRESSA Gefitinib 250mg Tablet
Me-too status Not found as per available DRAP database
Evaluator PEC-VIII
851. Name and address of Manufacturer / M/s. Wilson’s Pharmaceuticals, I-9, Industrial Area, Islamabad.
Applicant
Brand Name +Dosage Form +Strength Erlonib Tablet 25mg
Erlotinib hydrochloride… 25mg
Pharmacological Group Protein kinase inhibitors
Type of Form Form-5
Me-too status Tarceva 25mg tablet of Roche Pakistan Limited, Karachi
Remarks of Evaluator Reference product is approved as Erlotinib (as hydrochloride)
25mg film coated tablet which is different from applied
formulation i.e. Erlotinib hydrochloride 25mg film coated
tablet. Submit form 5, master formulation and manufacturing
method in line with innovator product.
Evidence of section approval?
Submission of Form 5 in-line with reference product i.e. Erlotinib (as hydrochloride) 25mg film
coated tablet.
Confirmation of required manufacturing facility for applied formulation.
Applicant
Type of Form Form-5
coated tablet.
Applicant
Type of Form Form-5
coated tablet.
Applicant
Brand Name +Dosage Form +Strength Imanib Tablets 100mg
Imatinib (as mesylate)… 100mg
Pharmacological Group Tyrosine kinase inhibitors
Type of Form Form-5
Me-too status Glivec 100mg Tablet Of Novartis Pharma (Pakistan) Ltd.,
Karachi
Remarks of Evaluator Evidence of section approval?
Decision: Deferred for confirmation of required manufacturing facility for applied formulation.
Applicant
Brand Name +Dosage Form +Strength Imanib Tablets 400mg
Imatinib (as mesylate)… 400mg
Pharmacological Group Tyrosine kinase inhibitors
Type of Form Form-5
Me-too status Glivec 400mg Tablet Of Novartis Pharma (Pakistan) Ltd.,
Karachi
Remarks of Evaluator Evidence of section approval?
Decision: Deferred for confirmation of required manufacturing facility for applied formulation.
Applicant
Brand Name +Dosage Form +Strength Dasanib Tablets 100mg
Dasatinib (as mesylate)… 100mg
Type of Form Form-5
Pack Size & Demanded Price 10’s, 20’s, 30’s; As per SRO
Remarks of Evaluator Evidence of me too is required.
Evidence of applied formulation/drug already approved by DRAP (generic / me-too status) alongwith
registration number, brand name and name of firm.
857. Name and address of Manufacturer / M/s. Werrick Pharmaceuticals, Plot No. 216-217, I-10/3,
Applicant Industrial Area, Islamabad.
Brand Name +Dosage Form +Strength Bruvica Tablets 140mg
Ibrutinib (as mesylate)… 140mg
Type of Form Form-5
Type of Form Form-5
Type of Form Form-5
Type of Form Form-5
Brand Name +Dosage Form +Strength HER-2 Capsules
Palbociclib…. 125mg
Type of Form Form-5
Applicant
Brand Name +Dosage Form +Strength Letzol tablets 2.5mg
Letrozole…. 2.5mg
Type of Form Form-5
Finished Product Specification USP Specifications (USP 2017)
Me-too status Losiral Tablet 2.5mg Of CCL Pharmaceuticals.
Decision: Approved.
863. Name and address of Manufacturer / M/s. Ameer & Adnan Pharmaceuticals, Plot # 47 Sunder
Applicant industrial estates, Lahore.
Brand Name +Dosage Form +Strength Adezol tablets 2.5mg
Letrozole…. 2.5mg
Type of Form Form-5
Finished Product Specification USP Specifications (USP 2017)
Pack Size & Demanded Price 10’s, 30’s, 60’s ; As per SRO
Me-too status Losiral Tablet 2.5mg Of CCL Pharmaceuticals.
inspection.
Remarks of Evaluator Type of primary packaging material of applied formulation.
(Applicant has submitted alu/alu blister as primary packaging
meterial)
Decision: Approved.
864. Name and address of Manufacturer / M/s. Seraph Pharmaceuticals, Plot # 210, industrial triangle,
Brand Name +Dosage Form +Strength Anzole Tablet 1mg
Anastrozole…. 1mg
Type of Form Form-5
Pack Size & Demanded Price 10’s; As per PRC
Me-too status Pantestone 1mg Tablet Of Ghazali Brothers, Karachi
GMP status Panel inspection conducted on 11-6-2018 recommended
issuance of GMP Certificate.
Decision: Approved.
Evaluator PEC-VI
865. Name and address of manufacturer / M/s Pacific Pharmaceuticals, Lahore
Applicant
Brand Name +Dosage Form + Strength Femizole 2.5mg tablet
Letrozole….2.5mg
Type of Form Form-5
Approval status of product in Reference FEMARA 2.5 mg Tablet by M/s Novartis Pharmaceuticals
Me-too status Aromek 2.5mg Tablet by M/s Glaxy Pharmaceuticals
(Reg#052258)
GMP status cGMP certificate is issued on the basis of evaluation conducted
on 22-2-2018
866. Name and address of manufacturer / M/s Neutro Pharma, Lahore
Applicant
Brand Name +Dosage Form + Strength Neustinb 50mg capsule
Sunitinib as Maleate………….50mg
Pharmacological Group Protein Kinase Inhibitor
Type of Form Form-5
Pack size & Demanded Price 30’s, As SRO
Approval status of product in Reference Sutent 50 mg capsules (Sunitinib as Malate) by Pfizer Ltd
Regulatory Authorities. Ramsgate Road Sandwich, Kent CT13 9NJ United Kingdom
(USFDA Approved)
Me-too status Sutent 50mg Capsule by M/s Pfizer (Reg. No. 052227)
GMP status Last inspection report 18-7-2017 Firm has maintained a fair
Decision: Deferred for evidence of required manufacturing facility of “Tablet (Oncology) section
approved by Licensing Division.
867. Name and address of manufacturer / M/s Neutro Pharma, Lahore
Applicant
Brand Name +Dosage Form + Strength Neutacroli 0.5mg capsule
Tacrolimus as monohydrate….0.5mg
Pharmacological Group Immunosuppressant
Type of Form Form-5
Approval status of product in Reference Prograf by Astellas Pharma
Me-too status Inograf 5 mg capsule by Platinum Pharma
which remain in direct contact or are involved in close handling of these drugs
Evaluator PEC-XII
868. Name and Address of Manufacturer / M/s Allmed (Private) Limited,

Applicant Plot no. 590, Sundar Industrial Estate, Lahore
Brand Name + Dosage Form + Strength Nitron 50mg Tablet
Diary No. Date of R & I & fee Diary No:13709, 12/04/2018, Rs: 20,000/- (Duplicate)
Deposit slip# 0747525 Dated: 28-02-2018
Nitrofurantoin …50mg
Pharmacological Group Other antibacterials (Nitrofuran derivatives)
Type of Form Form-5
Approval Status of Product in Reference Nitrofurantoin 50 mg Tablets by M/s Teva UK Limited
Me-too Status Furadin 50mg Tablet by M/s Ferozsons (Reg#011589)
Purpose: GMP Compliance
Conclusion: Satisfactory
Decision: Approved.
869. Name and Address of Manufacturer / Nabiqasim Industries (Pvt) Ltd.,
Applicant 17/24, Korangi Industrial Area, Karachi
Brand Name + Dosage Form + Strength Navospet 7.1% gel
Composition Each 10gm tube of gel contains:
Chlorhexidine digluconate 7.1% w/w eq. to Chlorhexidine
…4% w/w
Pharmacological Group Antiseptics and disinfectants (Biguanides and amidines)
Type of Form Form-5
Pack Size & Demanded Price 10gm / As per SRO
Approval Status of Product in Reference Not available in reference SRAs,
Regulatory Authorities. However available in WHO Model List of Essential Medicines
for Children and Nepal, Nigeria.
Me-too Status Umbilica Gel by M/s Atco Laboratories (Reg# 084771)
GMP Status Last inspection report 3-8-2017 firm is considered to be
operating at an acceptable level of compliance of GMP
Remarks of the Evaluator.  The monograph of applied formulation is available in BP
 Firm has not submitted stability study data of 3 batches as
per Zone IV-A.
 Letter issued on 04-06-2018.
Decision: Deferred for submission of stability study data as per the requirements of 278th meeting of
Registration Board.
870. Name and Address of Manufacturer / M/s Winilton pharma, Plot # 45, Street S-5, National
Applicant industrial zone, Rawat Islamabad.
Brand Name + Dosage Form + Strength Winzole 2.5mg Tablet
Letrozole …2.5mg
Type of Form Form-5
Pack Size & Demanded Price 10’s, 30’s / As per SRO
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#021129)
GMP Status Inspection date:3-10-2017
Purpose: Follow up inspection
Conlcusion: Fair level of compliance
871. Name and Address of Manufacturer / M/s Gulf Pharmaceuticals
Applicant Plot # 49 Street-5 National Industrial Zone Rawat Islamabad
Brand Name + Dosage Form + Strength Lyra-zit 2.5mg Tablet
Letrozole …2.5mg
Type of Form Form-5
GMP Status Last GMP inspection conducted on 02-2-2018 & 07-2-2018,
and report concludes recommendation for renewal of DML.
872. Name and Address of Manufacturer / M/s. Usawa Pharmaceuticals,
Applicant 146, special industrial zone, Risalpur, Nowshera.
Brand Name + Dosage Form + Strength Anazole 2.5mg Tablet
Letrozole …2.5mg
Type of Form Form-5
Routine GMP Inspection
Firm was issued certificate of cGMP based on inspection, for
tablet (general), capsule (general), capsule (cephalosporin)
and dry powder suspension (cephalosporin).
873. Name and Address of Manufacturer / M/s. Warafana Pharmaceuticals, Plot 125,126, 127, Industrial
Applicant Triangle, Kahuta Road Islamabad.
Brand Name + Dosage Form + Strength Wantrol 1mg Tablet
Anastrozole …1mg
Type of Form Form-5
Pack Size & Demanded Price 10’s, 4x7’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 GMP inspection dated on 12-07-2017 concluding that firm is
operating at fair level of compliance with GMP.
874. Name and Address of Manufacturer / M/s. Warafana Pharmaceuticals, Plot 125,126, 127, Industrial
Brand Name + Dosage Form + Strength Wetara 2.5mg Tablet
Letrozole …2.5mg
Type of Form Form-5
GMP Status GMP inspection dated on 12-07-2017 concluding that firm is
operating at fair level of compliance with GMP.
Evaluator PEC-III
875. Name and address of manufacturer / M/s Regal Pharmaceuticals Plot No. 2-A, street # S-5, National
Applicant Industrial Zone, Rawat, Islamabad
Brand Name +Dosage Form + Strength Rose Tablet 1mg
Anastrozole…….1mg
Type of Form Form 5
Approval status of product in Reference Arimidex Tablet by Astrazaneca
Me-too status Arimidex Tablet by ICI
Decision: Approved.
876. Name and address of manufacturer / M/s Jupiter Pharma, Plot No. 25, street S-6, National Industrial
Applicant Zone (RCCI), Rawat, Islamabad
Brand Name +Dosage Form + Strength J-Razil Tablet 2.5mg
Pharmacological Group Non-Steroidal aromatase inhibitor
Type of Form Form 5
Pack size & Demanded Price 1x10’s, 3x10’s: As per SRO
Approval status of product in Reference Femara Tablets by Novartis
Me-too status Femara Tablets by Novartis
GMP status Last inspection report dated 31-1-2018 confirms that firm is
operating at fair level of cGMP compliance.
Decision: Approved.
877. Name and address of manufacturer / M/s Nawan Laboratories (Pvt) Ltd., Plot No. 136-138, Sector 15,
Brand Name +Dosage Form + Strength Letzole Tablet 2.5mg
Type of Form Form 5
GMP status Last inspection report dated 26-9-2017 confirms that firm is
operating at satisfactory level of cGMP compliance.
Decision: Approved.
878. Name and address of manufacturer / M/s Shawan Pharmaceuticals, Plot No. 37, NS-01 Road, National
Applicant Industrial Zone, Rawat.
Brand Name +Dosage Form + Strength Ribavir Tablet
Ribavirin…….200mg
Type of Form Form 5
Approval status of product in Reference Ribavirin tablet by Sandoz
Me-too status Virazide tablets by Pharmedic
compliance to GMP.
Decision: Approved.
Brand Name +Dosage Form + Strength CancrGo Tablet
Type of Form Form 5
compliance to GMP.
Decision: Approved.
Brand Name +Dosage Form + Strength Aprine Tablet
Azathioprine……50mg
Type of Form Form 5
Approval status of product in Reference Imuran tablets by Aspen
Me-too status Imulite tablet by Crystollite Pharma
compliance to GMP.
Decision: Approved.
Evaluator PEC-XI
881. Name and address of manufacturer / M/s Siam Pharmaceutical, 217, Industrial Triangle, Kahuta
Applicant Road, Islamabad.
Brand Name +Dosage Form + Strength Anzole tablet 1mg
Other brand names proposed:
Trazole tablet 1mg
Antzole tablet 1mg
Tizole tablet 1mg
Anastrozole……………........1mg
Type of Form Form-5
Pack size & Demanded Price 1x10’s and 2x14’s; As decided by MoH
Me-too status (with strength and dosage Arimidex of M/s ICI Pakistan
form)
GMP status Last inspection conducted on 16-02-2018; the panel
unanimously recommended grant of renewal of DML
882. Name and address of manufacturer / M/s Atco Laboratories Limited, B-18, S.I.T.E., Karachi.
Applicant
Brand Name +Dosage Form + Strength Viracure DS tablet 500mg
Famciclovir……………........500mg
Type of Form Form-5
Pack size & Demanded Price 7’s; Rs.1400/- 10’s; Rs.2000/-
14’s; Rs.2800/- 20’s; Rs.4000/-
21’s; Rs.4200/- 28’s; Rs.5600/-
30’s; Rs.6000/-
Approval status of product in Reference TGA approved
Me-too status (with strength and dosage Miclovir tablet 500mg of M/s Cirin Pharmaceuticals (Pvt.) Ltd.
form)
GMP status Panel inspection conducted on 21-07-2017 concludes that
firm is operating at the good GMP compliance.
Decision: Approved
883. Name and address of manufacturer / M/s Atco Laboratories Limited, B-18, S.I.T.E., Karachi.
Applicant
Brand Name +Dosage Form + Strength Asylo Oral suspension 200mg/5ml
Acyclovir……………........200mg
Type of Form Form-5
Pack size & Demanded Price 60ml; Rs.1200/-
120ml; Rs.2400/-
Me-too status (with strength and dosage Acylex suspension of M/s Ferozsons Laboratories Ltd.
form)
GMP status Panel inspection conducted on 21-07-2017 concludes that
firm is operating at the good GMP compliance.
Decision: Approved
Evaluator PEC-VII
884. Name and address of Manufacturer / M/s Wilson’s Pharmaceuticals 387-388, I-9 industrial area
Applicant Islamabad
Brand Name+ Dosage Form+ Strength Ruxonib tablets 20 mg
Ruxolitinib (as phosphate) …20mg
Pharmacological Group Protein kinase inhibitor
Type of Form Form-5
Pack Size & Demanded Price 10’s,20’s, 60’s
As per SRO
Approval status of product in Reference Jakavi (Ruxolitinib) 20 mg tablet by M/s Novartis
Regulatory Authorities Pharmaceuticals Australia Pty Limited (TGA Approved)
Me-too status Jakavi 20mg Tablets M/s Novartis (Reg#078121)
Decision: Deferred for evidence of tablet oncology section.
Applicant Islamabad
Ruxolitinib (as phosphate) … 15 mg
Type of Form Form-5
Pack Size & Demanded Price 10’s,20’s, 60’s / As per SRO
Applicant Islamabad
Type of Form Form-5
As per SRO
Approval status of product in Reference Jakavi (Ruxolitinib) 5 mg tablet by M/s Novartis Pharmaceuticals
Regulatory Authorities Australia Pty Limited (TGA Approved)
Applicant Islamabad
Type of Form Form-5
As per SRO
Me-too status NA
Remarks of Evaluator  Evidence of applied formulation/drug already approved
by DRAP (generic / me-too status) alongwith registration
Applicant Islamabad
Brand Name+ Dosage Form+ Strength Afanib 20 mg tablet
Afatinib dimaleate eq to afatinib… 20mg
Diary No. Date of R&I & fee Dy No. 10891, 26-03-2018; Rs.20,000/-
Pharmacological Group Tyrosine Kinase Inhibitor
Type of Form Form-5
As per SRO
Approval status of product in Reference Gilotrif 20 mg of Boehringer Ingelheim (USFDA Approved)
Me-too status NA
Decision: Deferred for evidence of tablet oncology section and evidence of applied formulation/drug
already approved by DRAP (generic / me-too status) alongwith registration number, brand name and
name of firm.
Applicant Islamabad
Type of Form Form-5
As per SRO
Me-too status NA
Decision: Deferred for evidence of tablet oncology section and evidence of applied formulation/drug
name of firm.
Applicant Islamabad
Type of Form Form-5
Pack Size & Demanded Price 10’s,20’s, 30’s / As per SRO
Me-too status NA
Decision: Deferred for evidence of tablet oncology section and Evidence of applied formulation/drug
name of firm.
891. Name and address of Manufacturer / M/S Genome Pharmaceuticals (Pvt) Ltd. Plot#16/I-Phase IV,
Brand Name+ Dosage Form+ Strength Tofanib 200 mg tablet
Sorafenib as tosylte… 200mg
Pharmacological Group Antineoplastic
Type of Form Form-5
Approval status of product in Nexavar 200 mg film coated tablet by Bayer Australia Ltd (TGA
Reference Regulatory Authorities Approved)
Me-too status Nexavar 200mg Tablets By M/s Bayer Pakistan (Reg#052224)

Brand Name+ Dosage Form+ Strength Rouxit 10 mg tablet
Ruxolitinib as phosphate…… 10mg
Type of Form Form-5
Approval status of product in Jakafi of USFDA Approved
Me-too status Me-too status could not be confirmed
Remarks of Evaluator  Evidence of /me too missing
Decision: Deferred for evidence of tablet oncology section & evidence of me-too status
Brand Name+ Dosage Form+ Strength Uroxy 500 mg capsule
Composition Each capsule contains: Hydroxyurea …500mg
Pharmacological Group Anti-neoplastic
Type of Form Form-5
Approval status of product in Hydrea 500mg capsules by M/s Bristol-Myers Squibb Australia Pty
Reference Regulatory Authorities Ltd (TGA Approved)
Me-too status Hydrine Capsules 500mg by M/s Al-Habib (Reg#022625)
Decision: Deferred for evidence of oncology section
Evaluator PEC-II
894. Name and address of manufacturer / M/s Biolabs Pvt Ltd, Plot No.145 Kahuta Triangle Industrial
Applicant Estate, Islamabad.
Brand Name +Dosage Form + Strength Fovoten 300mg Tablet
Composition Each Film Coated Tablet Contains:
Tenofovir Disoproxil Fumarate Eq. to Tenefovir
Disoproxil…….300mg
Type of Form Form-5
Pack size & Demanded Price As recommended by PRC
Approval status of product in Tenofovir by Teva Pharma
Reference Regulatory Authorities. (USFDA Approved)
Me-too status Tenofo-B by Getz
GMP status The firm was granted GMP certificate based on inspection
conducted on 5th& 06-12-2017.
Decision: Approved
Brand Name +Dosage Form + Strength Tacrol 5mg Capsule
Composition Each Capsule Contains:
Tacrolimus……5mg
Type of Form Form-5
Me-too status Inograf 5 mg capsule by Platinum Pharma (Reg.# 045492)
condition that manufacturer shall provide safety and protective measures for workers and
Brand Name +Dosage Form + Strength Tacrol 1mg Capsule
Tacrolimus……1mg
Type of Form Form-5
Me-too status Inograf 1 mg capsule by Platinum Pharma (Reg.# 045491)
Brand Name +Dosage Form + Strength Tacrol 0.5mg Capsule
Tacrolimus……0.5mg
Type of Form Form-5
Me-too status Inograf 0.5 mg capsule by Platinum Pharma (Reg.# 045490)
Brand Name +Dosage Form + Strength Ribavir 200mg Capsule
Ribavirin…200mg
Type of Form Form-5
Approval status of product in Ribavirin 200 mg capsules, hard by Milpharm Limited
Me-too status Virazin Capsules 200mg by M/s Century Pharmaceutical
(Reg#021022)
Decision: Approved
Brand Name +Dosage Form + Strength Artiprine 50mg Injection
Azathioprine Sodium Eq. to Azathioprine…50mg
Type of Form Form-5
Approval status of product in Approved by Health Canada
Me-too status Azathioprine Pharmachemie of M/s S.M.Yahya & CO
(Reg#011141)
granting registration in Dry powder injection (lyophilised) section.
Brand Name +Dosage Form + Strength Artiprine 50mg Tablets
Composition Each Film Coated Tablet Contains:
Azathioprine…50mg
Type of Form Form-5
Me-too status Azoprine tablets by Global
Decision: Approved
Evaluator PEC-IV
901. Name and address of manufacturer / M/S Max Pharmaceuticals, Plot 312, St. No. N-7 National
Applicant Industrial Zone, Rawat, Islamabad, Pakistan
Brand Name +Dosage Form + Strength Latromax 2.5mg Tablet
Composition Each film coated tablet contain:
Letrozole anhydrous (U.S.P)……….2.5mg
Pharmacological Group Non Steroidal aromatase inhibitor
Type of Form Form 5
Pack size & Demanded Price 30’s; As per DPC
Approval status of product in FEMARA letrozole 2.5mg coated tablet by Novartis
Reference Regulatory Authorities Pharmaceuticals Australia Pty Ltd (TGA Approved)
Me-too status (with strength and Femara 2.5mg Tablet by Novartis (Reg. No. 021129)
dosage form)
GMP status Inspected on 13-03-2018 for grant of additional section i.e.
Cephalosporin Dry Powder Injection.
Remarks of the Evaluator Official monograph is available in USP pharamcopiea and
firm applied on manufacturer’s specification.
c. Import Applications of Priority Categories Defined by Registration Board in 257th
meeting.
i. Human
Evaluator PEC-V
902. Name and address of Applicant M/s Atco Laboratories Ltd B-18, S.I.T.E Karachi
Detail of Drug Sale License Address: B-18, S.I.T.E Karachi
Validity: 14-May-2019
Status: Drug License by Way of Wholesale
Name and address of manufacturer Drug Product Manufacturing Site + Primary Packaging
Hameln Pharmaceuticals Gmbh, Langes Feld 13, 31789,
Germany
Drug Product Batch Release+ Secondary Packaging
Geodis Logistics Netherlands B.V.,Columbusweg 16, 5928 LC
Venlo, The Netherlands
Name and address of marketing Cardiome UK Limited, Lakeside House , 1 Furzeground Way,
authorization holder Stockley Park, Uxbridge, Middlesex, UB11 1BD, United
Kingdom
Name of exporting country Belgium
Type of Form Form 5-A
Diary No. & Date of R& I Dy. No. 5188 Dated 13/02/2018
Fee including differential fee Rs. 100,000/- Dated 12/02/2018
Brand Name +Dosage Form + Strength BRINAVESS 20mg/ml Concentrate for Solution For Infusion
Vernakalant Hydrochloride 500mg eq. 452.5mg vernakalant
Pharmacological Group Cardiac Therapy , Other antiarthymic
ATC Code: C01BG11
Shelf life 5 years
Demanded Price 1’sx 25ml vial Rs. 89,100/-
Pack size 25 ml Vial
International availability USFDA Approved
Me-too status N/A
Detail of certificates attached Original legalized CoPP
Certificate No: 02/17/113531
Certifying Authority: European Medicines Agency
Free Sale: Confirms the free sale of the product in exporting
country.
GMP: The facilities and operations conform to WHO-GMP.
Issue Date: 05-10-2017
Agreement
Correvio International Sarl
Rue des Alpes 21, 1201 Geneva , Swizerland
&
M/s Atco Laboratories Ltd
Address: B-18, S.I.T.E Karachi
Date of Agreement: 11 August 2017
Validity: 5 years
Original Legalized Letter of Relationship
Cardiome UK Limited , The marketing authorization holder for
Brinavess , is the affiliate company of Correvio International
Sarl.
Remarks of the Evaluator. Approved with box warning in USFDA.
 The company responsible for batch release is Geodis
Logistics Netherlands B.V.,Columbusweg 16, 5928 LC
Venlo, The Netherlands. However, on Form 5A and
COPP the exporting country mentioned is Belgium.
Firm submitted:
The applied formulation is released by the qualified person at
Geodis Logistics Netherlands B.V. , Venlo, The Netherlands.
The product is subsequently stored in a warehouse at DSV
Solutions NV, Gent, Belgium , until it is shipped (exported) to
the markets for sale. As such, the batch release country is indeed
the Netherlands and the exporting country is Belgium. Belgium
as exporting region has been mentioned on COPP.
 Stability Studies
In the dossier submitted to support the registration of Brinavess,
2 batches (148052 and 225058) were tested for the full duration
of the stability program (30°C/65% RH for 60 months).at
following time points (6, 12, 24, 36, 48 ,54, 60 months).
However, accelerated stability data at 40°C/75%RH on
following 3 batches (009018, 009023, 009029) were presented.
Of note, the extension of the shelf-life from 4 years to 5 years
was approved in Europe by the European Medicines Agency in
January 2018.
Moreover, the Sponsor continues to monitor the stability of the

product as per the post-approval stability protocol. One
additional commercial batch (351053) has been tested at
30°C/65%RH up to 48 months and is currently still on the
stability program. The 60-month time point results for batch n°
351053 will be available in 2019. The Sponsor commits to
provide full results of the stability testing on this additional
batch, when available in 2019.
Decision: Approved as per policy of inspection for manufcaturer abroad.

903. Name and address of Applicant M/s Bio Medics Medical System,
F-597, F-Block, Satelite Town, Rawalpindi
Detail of Drug Sale License Address: F-597, F-Block, Satelite Town, Rawalpindi
Validity: 15-02-2020,
Status: License to sell drugs as a Distributor
Name and address of manufacturer M/s Ain Medicare SDN. BHD., Jalan 6/44, Kawasan
Perindustrain Pengkalan Chepa 2, 16100 Kota Bharu, Kelantan,
Malaysia.
Name and address of marketing M/s Ain Medicare SDN. BHD., Jalan 6/44, Kawasan
authorization holder Perindustrain Pengkalan Chepa 2, 16100 Kota Bharu, Kelantan,
Malaysia.
Name of exporting country Malaysia
Diary No. & Date of R& I Dy. No.1038 Dated 29/06/2016
Brand Name +Dosage Form + Strength INFUSOL SG 4% w/v IV infusion
Composition Each ltr contains:
Modified Fluid Gelatin………..40 gm
Finished Product Specification In House
Pharmacological Group Blood substitutes and plasma protein fractions
Shelf life 2 years
Demanded Price Rs. 395/- per bottle
Pack size 500ml LDPE bottle
International availability Volplex 4% w/v Solution for Infusion by M/s Beacon
Pharmaceutical Limited, MHRA Approved
Electrolytes
Sodium ion (Na+ ) 154 mmol/litre
Chloride ion (Cl) 125 mmol/litre
Me-too status N/A
Detail of certificates attached  Original legalized CoPP
Certificate No. : 0222/2018
Certifying Authority: Drug Control Authority, National
Pharmaceutical Control Bureau, Ministry of Health Malaysia
Free sale: confirms the free sale of the product in exporting
country.
Date of Issue: 29-Jan-2018
Validity: 24 Months
Remarks of the Evaluator.  The electrolytes mentioned in COPP are in grams while
approval in reference regulatory authority is in mmol.
 Firm has claimed that modified fluid gelatin is active
ingredient.However. internationally it is approved as
follows:
Succinylated gelatin (Modified Fluid Gelatin) 4% w/v in Water
for Injections, also containing sodium chloride.
Electrolytes
Sodium ion (Na+ ) 154 mmol/litre
Chloride ion (Cl) 125 mmol/litre
Firm provided the following calculation for mmol.
Sodium ion in Succinylated Gelatin 4% w/v is not only come
from Sodium Chloride but also from other material in the
Succinylated Gelatin 4%.
- Based on the above product composition in 1L, the electrolyte
strength for Na+ and Cl- are as follow:
Sodium Ion (Na+) 154mmol/L
Calculation :
NaCl = 4.384 g/L = 75mmol/L (Na+ = 75mmol/L; Cl- =
75mmol/L)
NaOH = 10.644 g/L = 79mmol/L (Na+ = 79mmol/L; OH- =
79mmol/L)
Thus Na+ in 1L of Succinylated Gelatin 4% is
75 mmol/L + 79 mmol/L = 154 mmol/L
Chloride Ion (Cl-) 120mmol/L

Calculation
NaCl = 4.384 g = 75mmol/L (Na+ = 75mmol/L; Cl- =
75mmol/L)
HCl = 9.028 g = 45.4 (H+ = 45.4mmol/L; Cl- = 75mmol/L)
Thus Cl- in 1L of Succinylated Gelatin 4% is
75 mmol/L + 45.4 mmol/L = 120.4 mmol/L
approximately 120mmol/L.
Decision: Approved as per policy of inspection for manufcaturer abroad.
Evaluator PEC-XII
904. Name and address of Applicant M/s Punjab Medical Services, Office No. 4,5 Jalal Centre 2nd
floor Opposite O.P.D gate Sir Ganga Ram Hospital Lahore
Detail of Drug Sale License Adress: Punjab Medical Services Pharmacy, Office No. 4,5 Jalal
Centre 2nd floor Opposite O.P.D gate Sir Ganga Ram Hospital
Lahore
Validity: 09/08/2019
Status: License to sell drugs in Pharmacy
Name and address of manufacturer M/s Onko İlaç Sanayi ve Ticaret A.Ş
Koşuyolu Cad. No:34, 34718, Kadiköy Istanbul, Turkey.
Manufacturing site: Gebze Organize Sanayi Bölgesi, 1700 Sokak,
No: 1703 Gebze, Kocaeli, Turkey.
Name and address of marketing M/s Onko İlaç Sanayi ve Ticaret A.Ş
authorization holder Koşuyolu Cad. No:34, 34718, Kadiköy Istanbul, Turkey.
Name of exporting country Turkey
Diary No. & Date of R& I Dy No. 15140: 24-4-2018
Fee including differential fee PKR 100,000/-: 24-04-2018
Brand Name +Dosage Form + Irontu 40mg/2ml IV solution for infusion
Strength
Irinotecan (as hydrochloride trihydrate) …40 mg
Pharmacological Group Other antineoplastic agents
Shelf life 2 Years
Demanded Price As per SRO
Pack size Type I glass vials containing 2ml concentrated solution in pack
size of 1’s
International availability Irinotecan 40 mg/2ml Concentrate for Solution for Infusion by
Sandoz Limited (MHRA Approved)
Me-too status Irinotecan hydrochloride trihydrate 20mg/ml vial (2ml) by M/s
AJ Mirza Pharma (Pvt) Ltd (Reg#032407)
Detail of certificates attached ● Original legalized CoPP issued on 21-03-2018 valid till 21-
03-2020 by Turkish Medicines and Medical Devices agency
confirms free sale of the manufacturer.
● Original legalized GMP certificate of the manufacturer is
submitted which is valid until May 2019. Certificate #
TR/GMP/2017/188.
● Original, legalized and valid Sole agency agreement by Onko
İlaç Sanayi ve Ticaret A.Ş located at Koşuyolu Cad. No:34,
34718, Kadiköy Istanbul, Turkey, issued on 22-03-2018 and
valid for 3 years is submitted by the firm.
 Firm has submitted 6 months accelerated stability study data and real-time stability study data for 24
months of 3 batches of batch 50602810, 50602820 and 50602410 manufactured in June 2015,(as per
Zone IV-A)
Initiation dates:
Batch #50602810 (16-07-2015)
Batch #50602820 (16-07-2015)
Batch #50602410 (16-07-2015)
Decision: Approved as per Policy for inspection of Manufacturer abroad.
Lahore
Brand Name +Dosage Form + Irontu 100mg/5ml IV solution for infusion
Strength
Irinotecan (as hydrochloride trihydrate) …100 mg
Pharmacological Group Other antineoplastic agents
Shelf life 2 Years
size of 1’s
International availability Irinotecan Hydrochloride 100 mg/5ml, concentrate for solution
for infusion. by Cipla (EU) Limited (MHRA Approved)
Me-too status Irinogen 100mg Injection by M/s Ferozesons Labs
(Reg#036077)
TR/GMP/2017/188.
months of 3 batches 50602510, 50602520 and 50602910 manufactured in June 2015, (as per Zone
IV-A)
Initiation dates:
Batch #50602510 (16-07-2015)
Batch #50602520 (16-07-2015)
Batch #50602910 (16-07-2015)
Lahore
Brand Name +Dosage Form + Docetu 20mg/ml concentrated solution for infusion
Strength
Docetaxel …20mg
Pharmacological Group Plant alkaloids and other natural products (Taxanes)
Shelf life 2 Years
size of 1’s
International availability Docetaxel Actavis 20mg/ml Concentrate for Solution for
Infusion by Actavis Group PTC ehf. (MHRA Approved)
Me-too status Docetaxel Varifarma Injection 20mg vial by M/s MEDINET
PHARMA (Reg#031344)
TR/GMP/2017/188.
months of 3 batches 50904200, 50904500 and 50904800manufactured in September 2015, (as per
Zone IV-A)
Initiation dates:
Batch #50904200 (30-10-2015)
Batch #50904500 (30-10-2015)
Batch #50904800 (30-10-2015)
Lahore
Brand Name +Dosage Form + Docetu 80mg/4ml concentrated solution for infusion
Strength
Docetaxel …80mg
Pharmacological Group Plant alkaloids and other natural products (Taxanes)
Shelf life 2 Years
size of 1’s
International availability Docetaxel Dr. Reddy’s 80 mg/4 ml Concentrate For Solution
For Infusion by Dr. Reddy’s Laboratories (UK) Ltd. (MHRA
Approved)
Me-too status ONCOTERE 80MG INJECTION vial by M/s Genetec
Laboratories (Reg#045634)
TR/GMP/2017/188.
months of 3 batches 50904300, 50904600 and 50904900 manufactured in September 2015, (as per
Zone IV-A)
Initiation dates:
Batch #50904300 (30-10-2015)
Batch #50904600 (30-10-2015)
Batch #50904900 (30-10-2015)
Lahore
Brand Name +Dosage Form + Gemtu 200mg/2ml concentrated solution for infusion
Strength
Gemcitabine hydrochloride …200mg
Pharmacological Group Antimetabolites (Pyrimidine analogues)
Shelf life 2 Years
size of 1’s
International availability Gemcitabine 100 mg/ml Concentrate for Solution for Infusion
(2ml vial) by M/s Accord Healthcare Limited (MHRA
Approved)
Me-too status GEMNIL INJECTION 200MG by M/s HAJI MEDICINE CO
(Reg#063982)
TR/GMP/2017/188.
months of 3 batches 60101210, 60101410 and 60101610 manufactured in January 2016, (as per
Zone IV-A)
Initiation dates:
Batch #60101210 (03-03-2016)
Batch #60101410 (03-03-2016)
Batch #60101610 (03-03-2016)
Lahore
Brand Name +Dosage Form + Gemtu 1000mg/10ml concentrated solution for infusion
Strength
Gemcitabine hydrochloride …1000mg
Shelf life 2 Years
size of 1’s
International availability Gemcitabine 100 mg/ml Concentrate for Solution for Infusion
(10ml vial) by M/s Accord Healthcare Limited (MHRA
Approved)
Me-too status GEMNIL INJECTION 1000MG by M/s HAJI MEDICINE CO
(Reg#063983)
TR/GMP/2017/188.
months of 3 batches 60201510, 60201610 and 60201710 manufactured in February 2016, (as per
Zone IV-A)
Initiation dates:
Batch #60201510 (11-03-2016)
Batch #60201610 (11-03-2016)
Batch #60201710 (11-03-2016)
Lahore
Brand Name +Dosage Form + 5-Frotu 1000mg/20ml solution for infusion
Strength
5-Fluorouracil …1000mg
Shelf life 2 Years
Pack size Type I glass vials containing 20ml solution in pack size of 1’s
International availability FLUOROURACIL EBEWE fluorouracil 1000mg/ 20mL
solution for injection vial by M/s Sandoz Pty Ltd (TGA
Approved)
Me-too status Not confirmed
TR/GMP/2017/188.
months of 3 batches 51005600, 51005700 and 51005800 manufactured in October 2015, (as per
Zone IV-A)
Initiation dates:
Batch #51005600 (20-11-2015)
Batch #51005700 (20-11-2015)
Batch #51005800 (20-11-2015)
 Me-too status not confirmed from available database.
Lahore
Brand Name +Dosage Form + Letu 2.5mg Film Coated Tablet
Strength
Letrozole …2.5mg
Shelf life 2 Years
Pack size 30’s
International availability LETROZOLE FBM letrozole 2.5 mg film-coated tablet blister
pack by M/s Southern Cross Pharma Pty Ltd (TGA Approved)
Me-too status Lezra Film Coated Tablet 2.5mg by M/s Excel Health Care
Laboratories (Pvt) Ltd (Reg#066001)
TR/GMP/2017/188.
months of 3 batches 50803500, 50803600 and 50803700 manufactured in August 2015, (as per Zone
IV-A)
Initiation dates:
Batch #50803500 (August-2015)
Batch #50803600 (August-2015)
Batch #50803700 (August-2015)
ii. Veterinary
Evaluator PEC-V
912. Name and address of Applicant M/s Mustafa Brothers, 186-D, Peoples Colony No.1, Faisalabad.
Detail of Drug Sale License Address: Mustafa Brothers, P-186-D, Peoples Colony No.1
Faisalabad.
Status: License to sell drugs as a Distributor
Name and address of manufacturer M/s Vetintez LLC
30 Smolna st. , kharkiv-61001, Ukraine
Production Site: 2 Liois Pasteur st
61075-Kharkiv City
Name and address of marketing M/s Vetintez LLC
authorization holder 30 Smolna st. , kharkiv-61001, Ukraine
Name of exporting country Ukraine
Brand Name +Dosage Form + Cocefen 200 Suspension for Injection (IM)
Strength
Composition Each 1 ml of drug contains:
Ceftiofur hydrochloride…50mg
Ketoprofen…150mg
Target species Cattle
Shelf life 2 years
Demanded Price Decontrolled
Pack size 100ml vial
International availability TGA Approved
Me-too status Could not confirmed
Detail of certificates attached  Original Legalized Free sale Certificate
Certificate No.: UA66300S
Certified by: Kharkiv Chamber of Commerce and Industry
Issued on: 06-06-2016
Validity: 06-06-2017
 Original GMP Certificate
Certificate No: UA1.007.X002300-15
Certified by: Kharkivstandartmetrologiia
Issue date: 29, May, 2015
Validity: 23, April, 2020
 Original Legalized License
License No. 065671
Issuing Authority: State Veterinary and Phytosanitory Service of
Ukraine
Status: Wholesale and Retail trade of Veterinary medicines and
Preparations
 Copy of Agreement
M/s Mustafa Brothers,
186-D, Peoples Colony No.1, Faisalabad.
&
M/s Vetintez LLC
30 Smolna st. , kharkiv-61001, Ukraine
Dated : 15-05-2015
Remarks of the Evaluator.  Withdrawl Period
Meat-8 days
Milk-0 hr
 Copy of certificate of Registration issued by Standard Global
Quality Certification (SGQC) issued on 13 June 2013 confirms
GMP (This certificate was expired on 12 June 2016).
 Internationally Ceftiofur as HCl
Decision: Deferred for following reasons:
 Free sale certificate and GMP certificate issued by Concerned Regulatory Authority / is
required.
 Clarification as the product is approved in reference regulatory authority as “Ceftiofur as
Hydrochloride” whereas firm has applied for “Ceftiofur Hydrochloride”.
913. Name and address of Applicant M/s UM Enterprises Plot No. 12, Sector 15, Korangi Industrial
Area Karachi
Detail of Drug Sale License Address: Plot No. 12, Sector 15, Korangi Industrial Area
Karachi
Status: Drug License by Way of wholesale.
Name and address of M/s Arab Veterinary Industrial Co. AVICO P.O. Box 150906
manufacturer Amman 11115 –Jordan
Name and address of marketing M/s Arab Veterinary Industrial Co. AVICO P.O. Box 150906
authorization holder Amman 11115 –Jordan
Name of exporting country Jordan
Brand Name +Dosage Form + Diaban Plus Suspension
Strength
Sulphadimidine as Sulphadimidine Sodium….21.3 mg
Sulphaguanidine ……………………………...21.3 mg
Sulphadiazine as sulphadiazine Sodium………28.4 mg
Streptomycin Sulphate………………………..7.6 mg
Neomycin Sulphate……………………………1.8mg
Hyoscine Hydrobromide………………………0.02 mg
Sodium Chloride………………………………11.33 mg
Calcium Gluconate……………………………2.2 mg
Magnesium Sulphate………………………….0.6 mg
Potassium Chloride…………………………...3.6 mg
Kaolin ……………………………………..103.3 mg
Pectin………………………………………7.1 mg
Glycine……………………………………..20.9 mg
Pharmacological Group Antidiahorreal
Shelf life 2 year
Demanded Price 225 ml:1400/Pkr
Pack size 225ml, Plastic Bottles
International availability New Zealand (Incorrect)
Me-too status ---
Detail of certificates attached Orginal and Legalized Free Sale Certificate
Certificate No.: 007368
Certifying Authority: Ministry of Agriculture/the Veterinary
Department –Pharmacy and Drugs Control Division
Issue date: 14-09-2017
GMP Certificate
Certificate No. 000304
Certifying Authority: Ministry of Agriculture/the Veterinary
Department –Pharmacy and Drugs Control Division
Agreement
M/s UM Enterprises, Plot No. 12, Sector 15, Korangi Industrial
Area &
M/s Arab Veterinary Industrial Co. AVICO P.O. Box 150906
Amman 11115 –Jordan
Date:12 June, 2012
Remarks of the Evaluator. Target Specie
Calve, Lamb, Foal, Dogs and Cats
Withdrawal period:
Meat: 14 days.
Milk: DIABAN PLUS should not be used in lactating cattle.
 The international availability is incorrect. Evidence of
approval of applied formulation in reference regulatory
authorities/agencies which were declared/approved by the
Registration Board in its 275th meeting.
 The assay has been performed on only Sulphadimidine as
Sulphadimidine Sodium, Sulphaguanidine ,Sulphadiazine
as sulphadiazine Sodium and not on other active
ingredients.
 Assay analysis of all active ingredients not provided (Mentioned only Sulphadimidine as
Sulphadimidine Sodium, Sulphaguanidine and Sulphadiazine as sulphadiazine Sodium.
Evaluator PEC-III
914. Name and address of Applicant M/s Ghazi Brothers, Ghazi House, D-35, K.D.A. Scheme
No. 1, Miran Muhammad Shah Road Karachi.
Detail of Drug Sale License
Name and address of manufacturer Virbac Vietnam Company Limited Song May Industrial Zone
Trang Bom District, Dong Nai Province, Vietnam
Name and address of marketing Virbac Vietnam Company Limited Song May Industrial Zone
authorization holder Trang Bom District, Dong Nai Province, Vietnam
Name of exporting country Vietnam
Brand Name +Dosage Form + Maxflor 10% (Powder for oral use)
Strength
Florfenicol……….100g
Finished Product Specification Firm has claimed in house specification.
Shelf life 2 Years (along with stability data as per zone IV-A)
Pack size 100g, 1Kg, 5Kg and 25Kg
International availability N.A
Me-too status NA
Detail of certificates attached Free Sale Certificate:
Firm has submitted original, legalized free sale certificate
which was valid till 16-1-2017.
GMP:
Firm has submitted legalized copy of GMP certificate (No.
13/75934) issued by ANSES France on 08-04-2013.
Firm has also submitted copy of GMP certificate issued by
Department of Animal Health Ministry of Agriculture & Rural
Development on 25-4-2013.
Sole Agency Agreement:
Firm has submitted legalized copy of Power of Attorney
between applicant firm and marketing authorization holder in
Vietnam.
Site Master File:
Firm has submitted legalized copy of site master file.
 Firm has submitted that they have applied for renewal of drug sale license and they will
submit it as soon as they it will be received.
 Firm has submitted that the original free sale certificate was valid at the time of submission
and has requested to consider their application.
Decision: Deferred for submission of valid Drug Sale License.
Case No. 05: Registration applications of Import Cases:

Evaluator PEC-III
915. Name and address of Applicant M/s Mehran International, 498D Hume Road Quaideen Colony
Karachi
Detail of Drug Sale License Address: 498/C Feroz Shah Mehta Road Karachi
Status: Drug License by Way of Whole sale
Name and address of manufacturer M/s Shandong Shenglu Pharmaceutical Co., Ltd. North of Sihe
Road street sishui, Shandong, China
Name and address of marketing M/s Shandong Shenglu Pharmaceutical Co., Ltd. North of Sihe
authorization holder Road street sishui, Shandong, China
Name and address of exporter M/s Ninhua GroupCo. Ltd., 21 Jiangxia street, Ningbo, P.R. China
Name of exporting country China
Brand Name +Dosage Form + HYD-CORT Injection 100mg
Strength
Hydrocortisoen Sodium succinate eq to
hydrocortisone………100mg
Shelf life 3 years (Supported by stability study data as per Zone IV-A
conditions)
Demanded Price Rs. 63.50/-
Pack size 1x1’s
International availability Solu-cortef injection by Pharmacia and Upjohn
(USFDA Approved)
Me-too status Hy-cortisone injection by Cirin Pharmaceuticals
Detail of certificates attached  Firm has submitted original legalized CoPP (No. 20150401) issued
by Sishui Food and Drug Administration dated 8-5-2015 (valid for
5 years) confirming free sale of the product and GMP of the
manufacturer.
 Firm has submitted copy of sole agency agreement between the
applicant, manufacturer abroad and exporter.
Karachi
Brand Name+Dosage Form+Strength HYD-CORT Injection 250mg
Hydrocortisone Sodium succinate eq to
Shelf life 3 years (Supported by data as per Zone IV-A)
Demanded Price Rs. 111/-
Pack size 1x1’s
(USFDA Approved)
manufacturer
Karachi
Strength
Pack size 1x1’s
(USFDA Approved)
manufacturer
Karachi
Strength
Pack size 1x1’s
(USFDA Approved)
manufacturer
Evaluator PEC-V
919. Name and address of Applicant M/s Getz Pharma (Pvt) Ltd., 29-30/27, Korangi Industrial Area,Karachi
Detail of Drug Sale License Address: 29-30/27, Korangi Industrial Area, Karachi
Status: drug sale license by the way of wholesale
Name and address of M/s Sava Healthcare Limited, At: 507-B to 512, G.I.D.C Estate
manufacturer Wadhwan City-363 035, Dist. Surendranagar, Gujrat, India
Name and address of marketing M/s Sava Healthcare Limited, At: 507-B to 512, G.I.D.C Estate
authorization holder Wadhwan City-363 035, Dist. Surendranagar, Gujrat, India
Name of exporting country India
Fee including differential fee PKR 100,000/- dated 03-08-2016
Brand Name +Dosage Form + Saltra DPI (Powder for inhalation) 50mcg+250mcg
Strength
Salmeterol xinafoate eq to salmeterol………50mcg
Fluticasone propionate…………250mcg
Pharmacological Group Adrenergics in combination with corticosteroids or other drugs, excl.
Anticholinergics
Shelf life 24 months
Pack size 30’s (Bottle)
International availability Advair Diskus 250/50 by Galaxo GRP (USFDA Approved)-available as
inhaler
Detail of certificates attached  Original, legalized CoPP
Certificate No. MFG/WHO COPP/SAVA/2016/125457) Issued by: The
commissioner of food and drug control administration Gujrat state India
Valid till: 23/08/2018
Free sale status in country of origin: Yes
GMP Complaint: Yes
Copy of GMP certificate
Valid till 23-8-2018
Issued by: Food and Drug Administration Gujrat State India is provided
Remarks of the Evaluator.  The firm has claimed In House specifications while the official
monograph is available is USP & B.P. for the dry powder to be used
in dry powder inhalers.
 This product is approved by USFDA as powder contained in an
inhaler device, while the applied product is a capsule containing
powder of inhalation. Justify the use of capsule and scientifically
demonstrate whether the capsule will yield similar bioavailability as
compared to the reference approved product of USFDA.
The firm has submitted that:
As the product is meant for inhalation BE is not performed for the same.
The said combination is well established and efficacy is well
documented. Further, tests Particle size distribution and uniformity of
delivered dose are performed during release and stability testing to
established Dose Delivery.
Monodose dry powder pulmonary inhaler for use with size 3 capsules.
Stability Studies
Accelerated : 40C/75%RH
|Real Time: 30C/75%RH
 The provided stability data mentioned the brand name as
Flutiair S Puffcaps. Firm has submitted that in the country of
origin(INDIA) the product is marketed with the name of
Flutiair. However, for Pakistan brand name is Saltra DPI.
Decision: Deferred for confirmation whether applied formulation can be imported from India or
otherwise as per prevailing Import Policy Order.
920. Name and address of Applicant M/s Getz Pharma (Pvt) Ltd., 29-30/27, Korangi Industrial Area, Karachi
Detail of Drug Sale License Address: 29-30/27, Korangi Industrial Area, Karachi
Name and address of M/s Sava Healthcare Limited, At: 507-B to 512, G.I.D.C Estate
manufacturer Wadhwan City-363 035, Dist. Surendranagar, Gujrat, India
Name and address of marketing M/s Sava Healthcare Limited, At: 507-B to 512, G.I.D.C Estate
authorization holder Wadhwan City-363 035, Dist. Surendranagar, Gujrat, India
Fee including differential fee PKR 100,000/- dated 03-08-2016
Brand Name +Dosage Form + Saltra DPI (Powder for inhalation) 50mcg+500mcg
Strength
Salmeterol xinafoate eq to salmeterol………50mcg
Fluticasone propionate…………500mcg
Finished Product Specification in house
Pharmacological Group Adrenergics in combination with corticosteroids or other drugs, excl.
Anticholinergics
Pack size 30’s (Bottle)
International availability  Advair Diskus 50/500 by Galaxo GRP (USFDA Approved)-available
as inhaler
Detail of certificates attached  Original, legalized CoPP
Certificate No. MFG/WHO COPP/SAVA/2016/125456) Issued by: The
commissioner of food and drug control administration Gujrat state India
Valid till: 23/08/2018
Free sale status in country of origin: Yes
GMP Complaint: Yes
Copy of GMP certificate
Issued by: Food and Drug Administration Gujrat State India is provided
Remarks of the Evaluator.  The firm has claimed In House specifications while the official
monograph is available is USP & B.P. for the dry powder to be used
in dry powder inhalers.
 This product is approved by USFDA as powder contained in an
inhaler device, while the applied product is a capsule containing
powder of inhalation. Justify the use of capsule and scientifically
demonstrate whether the capsule will yield similar bioavailability as
compared to the reference approved product of USFDA.
The firm has submitted that as the product is meant for inhalation BE is
not performed for the same. The said combination is well established
and efficacy is well documented. Further, tests Particle size distribution
and uniformity of delivered dose are performed during release and
stability testing to established Dose Delivery.
Monodose dry powder pulmonary inhaler for use with size 3 capsules.
Stability Studies
Accelerated : 40C/75%RH
|Real Time: 30C/75%RH
 The provided stability data mentioned the brand name as Flutiair S
Puffcaps. Firm has submitted that in the country of origin(INDIA) the
product is marketed with the name of Flutiair. However, for Pakistan
brand name is Saltra DPI.
Decision: Deferred for confirmation whether applied formulation can be imported from India or
otherwise as per prevailing Import Policy Order.
921. Name and address of Applicant M/s Global Pharmaceutical (Pvt.) Ltd., plot No. 22-23, Kahuta Industrial
Triangle, Islamabad.
Detail of DSL Address: Plot No. 22-23, Kahuta Industrial Triangle, Islamabad.
Validity: 16 March 2019
Status: License to sell drugs in a wholesale distributor
Name and address of M/s AY Pharmaceuticals Co., Ltd., Saitama Plant 6-8, Haichiman,
manufacturer Khawajima-machi, Hiki-gun, Saitama, Japan
Name and address of Marketing M/s Ajinomoto Pharmaceuticals Co., Ltd., 1-1, Irifune 2-chrome, Chuo-
authorization holder ku, Tokyo, Japan
Exporting country Japan
Brand Name+Dosage Form + PN-TWIN NO.1 Intravenous Infusion
Strength
Composition Each bag of 1000ml Contains:
Solution I
Glucose….. 120g
Sodium Chloride…… 2.920g
Potassium Acetate…...2.160g
Monobasic Potassium Phosphate…..1.088g
Magnesium Sulfate….0.7400g
Calcium Gluconate….1.792g
Zinc Sulfate Hydrate….5.752mg
Citric Acid Hydrate…..Optimum Dose
Water for Injection…...Optimum Dose
Solution II
L-Isoleucine….…..1.120g
L-Leucine………...2.500g
L-Lycine Acetate...2.480g
L-Methionine…….0.700g
L-Phenylalanine….1.870g
L-Threonine……...1.300g
L-Tryptophan…….0.260g
L-Valine………….0.900g
L-Alanine………...1.240g
L-Arginine……….1.580g
L-Aspartic Acid….0.760g
L-Cysteine……….0.200g
L-Glutamic Acid…1.300g
L-Histidine……….1.200g
L-Proline……….0.660g
L-Serine………..0.440g
L-Tyrosine……..0.070g
Glycine………...2.140g
Sodium Bisulfate..0.030g
Water for Injection….Optimum Dose
Pharmacological Group Supplement of water, Electrolyte, Amino Acid and Calories for patients
(TPN)
Finished product Specification In House
Shelf life 3 years
Pack size Double chamber Kit Preparation that consists of Solution I (glucose and
Electrolyte) and Solution II (Amino Acid) divided with a partition in a
plastic container.
International Availability Available in Japan as per CoPP
Me-too status N/A
Issued by: Ministry of Health, Labour and Welfare, Government of
Japan on11/06/2014
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 for In House manufacturing specifications
while the product is not present in USP/BP.
 The name of manufacturer mentioned in form 5-A and distribution
agreement is different from the name written on CoPP.
 The CoPP shows the marketing authorization holder and
manufacturer of the product is Ay Pharmaceuticals Co.,
Ltd.).While according to form 5-A and distribution agreement the
marketing authorization holder is “M/s Ajinomoto
Pharmaceuticals Co., Ltd.”
Decision: Deferred for clarification since the CoPP mentions the marketing authorization holder and
manufacturer of the product as “Ay Pharmaceuticals Co., Ltd”.Whereas, Form 5-A and distribution
agreement between importer and exporter mentions marketing authorization holder as “M/s
Ajinomoto Pharmaceuticals Co., Ltd”.
922. Name and address of Applicant M/s Hakimsons (Impex) pvt. Limited,
Hakimsons building, 19-west wharf road, Karachi.
Detail of Drug Sale License Address: Hakimsons building, 19-west wharf road, Karachi.
Validity: 15-Sep-2019
Status: Drug License by way of Wholesale
Name and address of manufacturer M/s Mylan Laboratories Limited
Plot No. 1606-1609, G.I.D.C
Sarigam, Dist. Val Sad, Gujrat, India
Name and address of marketing M/s Mylan Laboratories Limited, Plot No. 1606-1609, G.I.D.C
authorization holder Sarigam, Dist. Val Sad, Gujrat, India
Brand Name +Dosage Form + ZINNIA F
Strength
Composition Each sugar coated white tablet contains:
Levonorgestrel………………. 150mcg
Ethinylestradiol…………….... 30mcg
Each sugar coated brown tablet contains:
Ferrous fumarate…………….. 75mcg eq. to Ferrous iron 24.375mg
Pharmacological Group contraceptive
Shelf life 5 years
Demanded Price Decontrolled for UNFP/USAID supplies only
Pack size Combo pack of 21 tablets of Levonorgestrel + Ethinylestradiol and 7
Tablets of Ferrous fumarate.
3 Blisters of 28 Tablet Each
rd
399
International availability Ovranette® 150/30 micrograms sugar Coated Tablets.
MHRA Approved
Me-too status Could not be confirmed.
Issued by: Food and Drugs Control Administration, Gujarat state,
India
Valid up to: 09/04/2019
The facilities and operations conform to WHO-GMP.
Remarks of the Evaluator. The firm has claimed In House specifications while both tablets are
present in USP and BP.
Following are the short comings:
 Evidence of approval of the product in reference regulatory
authorities since the product is approved in USFDA in different
strength and me too status of the product.
 No combo pack and sugar coated tablet could be confirmed for
Me-too.
 Confirmation whether applied formulation can be imported from India or otherwise as per
prevailing Import Policy Order.
 Evidence of approval of applied formulation as combo pack in reference regulatory
alongwith registration number, brand name and name of firm as combo pack.
923. Name and address of Applicant M/s. Macter International Limited, F-216, S.I.T.E, Karachi
Detail of Drug Sale License Address: M/s. Macter International(Pvt.) Limited,
F-216, S.I.T.E, Karachi
Validity: 07-Aug 2019
Status: Drug License by way of wholesale (renewal)
Address of godown: F-216A S.I.T.E, Karachi
Name and address of manufacturer M/s ACS Dobfar S.p.A
Viale Addetta 4/12
Tribiano Italy
(Manufacturing of drug substance)
M/s. Facta Farmaceutici S.p.A
Nucleo industrial S.Atto,
S. Nicolo a Tordino,
64100 Teramo-Italy,
Steps performed:
 Re-test of sterile Meropenem blend
 Control of primary packaging material
 Filling of vials
 Packaging
 In-process controls
 Control and release of drug product
(As per Form 5 A)
Name and address of marketing (Needs Clarification)
authorization holder
Name of exporting country Italy
Brand Name +Dosage Form + Ropen Injection 500 mg powder for solution (IV Infusion)
Strength Other Proposed name Meromac
Composition Each vial ampoule contains:
Meropenem trihydrate…..570mg eq to meropenem anhydrous 500mg
Sodium carbonate………………104 mg eq to sodium 45.1mg
Pharmacological Group Antiinfectives for Systemic Use
Antibacterials for Systemic Use
Other Beta-Lactam Antibacterials
Carbapenems
ATC Code: J01DH02
Demanded Price Rs. 2500/S
Pack size 1’s x 20 ml vial un-colored glass vials type III stoppered with
bromobutyl rubber stopper having diameter 20 mm.
International availability USFDA approved
Brand Name: Meroget Powder for Solution for Infusion or Injection
Manufacturer Name: Getz Pharma, Karachi
Detail of certificates attached Legalized of Original CoPP
Certificate No. N°CPP/2016/2787
Certified by :AIFA
Issue Date:30, Dec 2016
Free sale in Exporting country: Yes
GMP: Yes
Copy of GMP
GMP certificate No. IT/193-2/H/2016
Validity: 3 years
Agreement Copy
M/s ACS Dobfar S.p.A & : M/s. Macter International(Pvt.) Limited,
Dated: 28, sep,2016
Remarks of the Evaluator.  The legalized original translated COPP is missing.
 Status of manufacturers differ from Form 5 A.
 The brand name mentioned on COPP is MEROPENEM HIKMA
whereas firm has initially applied for Ropen, later on proposed
different name i.e. Meromec.
 Zambon Switzerland is mentioned on CoPP as site responsible for
packaging of batches whereas Form 5 A does not specify status of
Zambon.
 Credentials are not signed by authorized personal.
 Authority letter from marketing authorization holder is
missing.Firm has stated that Macter has no relationship with Hikma
and product will be imported from Facta Plant. Marketing rights of
the product in Italy is with Hikma.
 Submission of original, legalized and translated COPP mentioning clear status of
manufacturers.
 Clarification regarding Brand name as Brand name mentioned on COPP is MEROPENEM
HIKMA whereas applied Brand name is Meromec.
 Clarification as Zambon Switzerland is mentioned on CoPP as site responsible for packaging
of batches whereas Form 5 A does not specify status of Zambon.
 Submission of credentials duly signed by the manufacturer.
 Authorization letter from marketing authorization Holder.
924. Name and address of Applicant M/s. Macter International Limited, F-216, S.I.T.E, Karachi
Detail of Drug Sale License Address: M/s. Macter International(Pvt.) Limited,
F-216, S.I.T.E, Karachi
Validity: 07-Aug 2019
Status: Drug License by way of wholesale (renewal)
Address of godown: F-216A S.I.T.E, Karachi
Name and address of manufacturer M/s. Facta Farmaceutici S.p.A
Nucleo industrial S.Atto,
S. Nicolo a Tordino,
64100 Teramo-Italy,
Steps performed:
 Re-test of sterile Meropenem blend
 Control of primary packaging material
 Filling of vials
 Packaging
 In-process controls
 Control and release of drug product
(As per Form 5 A)
Name and address of marketing Needs Clarification
Brand Name +Dosage Form + Ropen Injection 1 g powder for solution (IV Infusion)
Strength
Composition Each vial ampoule contains:
Meropenem trihydrate ..1140mg eq to meropenem anhydrous 1000mg
Sodium carbonate………………208 mg eq to sodium content 90.2mg
Pharmacological Group Antiinfectives for Systemic Use
Antibacterials for Systemic Use
Other Beta-Lactam Antibacterials
Carbapenems
ATC Code: J01DH02
Demanded Price Rs. 2500/S
Pack size 1’s x 20 ml vial un-colored glass vials type III stoppered with
bromobutyl rubber stopper having diameter 20 mm.
International availability USFDA approved
Brand Name: Meroget Powder for Solution for Infusion or Injection
Manufacturer Name: Getz Pharma, Karachi
Detail of certificates attached Copy of CoPP
Certificate No. N°CPP/2016/2788
Certified by :AIFA
Issue Date:30, Dec 2016
Free sale in Exporting country: Yes
GMP: Yes
Copy of GMP
GMP certificate No. IT/193-2/H/2016
Validity: 3 years
Remarks of the Evaluator.  The legalized original translated COPP is missing.
 The brand name mentioned on COPP is MEROPENEM
HIKMA whereas firm has initially applied for Ropen, later on
proposed different name i.e. Meromec.
 Zambon Switzerland is mentioned on CoPP as site
responsible for packaging of batches whereas Form 5 A does
not specify status of Zambon.
 Credentials are not signed by authorized personal.
 Authority letter from marketing authorization holder is
missing. Firm has stated that Macter has no relationship with
Hikma and product will be imported from Facta Plant.
Marketing rights of the product in Italy is with Hikma.
 Submission of original, legalized and translated COPP mentioning clear status of
manufacturers.
 Clarification regarding Brand name as Brand name mentioned on COPP is MEROPENEM
HIKMA whereas applied Brand name is Meromec.
 Clarification as Zambon Switzerland is mentioned on CoPP as site responsible for packaging
of batches whereas Form 5 A does not specify status of Zambon.
 Submission of credentials duly signed by the manufacturer.
 Authorization letter from marketing authorization Holder.
Evaluator PEC-II
925. Name and address of Applicant M/s Mukhtar Enterprises, 55 Block B, Faisal Town Lahore, Pakistan.
Detail of Drug Sale License Address: M/s Mukhtar Enterprises, 1st floor 55-B Faisal Town Lahore.
Status: License to sell drugs as a “Distributor”
Name and address of manufacturer M/s Pharmathen S.A 6, Dervenakion, Str., 15351 Pallini, Attikis,
Greece.
Name and address of marketing M/s Pharmathen S.A., 6, Dervenakion Str., 15351 Pallini - Attikis,
authorization holder Greece.
Number of Product License; 96005/13/26
Name of exporting country Greece
Diary No. & Date of R& I Dy. No. 15143 Dated 24-04-2018
Fee including differential fee Rs. 50,000/- Dated 24-04-2018
Brand Name +Dosage Form + Cemet solution for injection/infusion 2mg/ml
Strength
Composition Each 10 ml ampoule contains:
Cisatracurium besilate eq. to Cisatracurium…… 2mg per ml
Pharmacological Group Neuromuscular blocking agent
Shelf life 2 years at 2 – 8oC
Demanded Price
Pack size 1’s
Injection is supplied in 10ml transparent glass (type I) ampoules each
containing 20mg of Cisatracurium. The ampoules are packaged in a
cardboard box with an instruction leaflet.
International availability Approved by MHRA of UK
Me-too status N/A
Detail of certificates attached  Original CoPP
Certificate No: 10986
Certifying Authority: National Organization for Medicines (EOF),
Athens, Greece.
Free sale in exporting country: Yes
 GMP: The facilities and operations of manufacturing site conform
to GMP as recommended by WHO.
 GMP Certificate
Certificate no. 40188/12-5-2016
Manufacturer Address: M/s Pharmathen S.A 6, Dervenakion, Str.,
15351 Pallini, Attikis, Greece.
Legalized copy of GMP certificate issued by National Organization for
Medicines (EOF), Athens, Greece.
 The above cited certificate has been verified from website of
“Eudragmdp” as accessed on 17-05-2018.
 Legalized copy of “Certificate of Manufacturer’s Authorization”.
Authorisation No.: 0000006501/15/1
The certificate declares authorisation for manufacturing operations of
Sterile products for both Large volume liquids & Small volume
liquids.
Remarks of the Evaluator:
 The original CoPP mentions only strength of the applied formulation whereas fill volume has not been
mentioned in CoPP.
 USP monograph is available for applied formulation, whereas firm has applied in house method for assay
analysis. Clarification shall be submitted in this regard.
 Firm has submitted 24 months long term stability data of three batches conducted at 5 oC + 3 o C and 2
months accelerated stability data of three batches conducted at 25oC + 2 o C & 60% + 5%.
 Urdu version of outer carton label has not been submitted.
 Upon communication of above observations vide letter no. F.1-1/2017/PEC-DRAP (AD PEC-II) dated 24-
05-2018, firm has responded as under:
Sr.# Observations Firm’s reply

i. The original CoPP mentions Please note that the MA (marketing authorization) granted in
only strength of the applied Greece is for the 2mg/ml concentration and covers all the ampoule
formulation whereas fill sizes.
volume has not been The Greek MA is attached at for your reference; we have
mentioned in CoPP highlighted the relevant sections noting the concentration which
is common, and the relevant ampoule sizes which are approved.
Firm’s claim has been verified from following web-link of
Greece National Organization for Medicines (accessed on 20-06-
2018) wherein marketing authorization mentions the availability
of 10ml fill volume of applied formulation
http://www.eof.gr/web/guest/search;jsessionid=b4588491a21
05ed97925917ef898
ii. USP monograph is available Pharmathen S.A would like to clarify that assay analytical method
for applied formulation, corresponds to the USP assay method for Atracurium besylate. It
whereas firm has applied in should be clarified that, during development of the product, no
house method for assay USP monograph for applied formulation of Cisatracurium was
analysis. Clarification shall available. Thus, Pharmathen adopted the assay method described
be submitted in this regard. in USP monograph for similar product “Atracurium besylate”.
The method has been fully validated according to the ICH
guidelines on analytical method validation
iii. Firm has submitted 24 Kindly note that all necessary information can be found in the
months long term stability stability summary in 32p81 (Annex C)“the stability is completed
data of three batches up to 24 months for normal conditions. However, the stability
conducted at 5°C± 3°C and study for accelerated conditions (up to 6 months) has ended at 2
2 months accelerated months as impurity C2 was out of specifications”. Thus the
stability data of three product has been studied only under long term conditions.
batches conducted at Storage conditions will be declared for the product. On the basis
25°C±2 °C & 60% ± 5%. of the 24-month real time stability testing shelf life of 24 months
Complete 6 months is predicted when stored in a refrigerator at 2-8°C.
accelerated stability data for
three batches shall be
submitted.
iv. Urdu version of outer carton Submitted
label has not been submitted.
Decision: Approved as per policy of inspection of manufacturers abroad
926. Name and address of Applicant M/s Mukhtar Enterprises, 55 Block B, Faisal Town Lahore, Pakistan.
Detail of Drug Sale License Address: M/s Mukhtar Enterprises, 1st floor 55-B Faisal Town Lahore.
Status: License to sell drugs as a “Distributor”
Name and address of manufacturer M/s Pharmathen S.A 6, Dervenakion, Str., 15351 Pallini, Attikis,
Greece.
Name and address of marketing M/s Pharmathen S.A., 6, Dervenakion Str., 15351 Pallini - Attikis,
authorization holder Greece.
Number of Product License; 96005/13/26
Name of exporting country Greece
Diary No. & Date of R& I Dy. No. 15144 Dated 24-04-2018
Fee including differential fee Rs. 50,000/- Dated 24-04-2018
Brand Name +Dosage Form + Cemet solution for injection/infusion 2mg/ml
Strength
Cisatracurium besilate eq. to Cisatracurium…… 2mg per ml
Pharmacological Group Neuromuscular blocking agent
Shelf life 2 years at 2 – 8oC
Demanded Price
Pack size 1’s Injection is supplied in 5ml transparent glass (type I) ampoules
each containing 10mg of Cisatracurium. The ampoules are packaged
in a cardboard box with an instruction leaflet.
International availability Approved by MHRA of UK
Me-too status N/A
Detail of certificates attached  Original CoPP
Certificate No: 10986
Certifying Authority: National Organization for Medicines (EOF),
Athens, Greece.
 GMP: The facilities and operations of manufacturing site conform
 GMP Certificate
Certificate no. 40188/12-5-2016
Manufacturer Address: M/s Pharmathen S.A 6, Dervenakion, Str.,
15351 Pallini, Attikis, Greece.
Legalized copy of GMP certificate issued by National Organization for
Medicines (EOF), Athens, Greece.
 The above cited certificate has been verified from website of
“Eudragmdp” as accessed on 17-05-2018.
 Legalized copy of “Certificate of Manufacturer’s Authorization”.
Authorisation No.: 0000006501/15/1
The certificate declares authorisation for manufacturing operations of
Sterile products for both Large volume liquids & Small volume
liquids.
Remarks of the Evaluator:
 Distribution agreement has been submitted between applicant and manufacturer/marketing authorisation
holder.
 The original CoPP mentions only strength of the applied formulation whereas fill volume has not been
mentioned in CoPP.
 USP monograph is available for applied formulation, whereas firm has applied in house method for assay
analysis. Clarification shall be submitted in this regard.
 Firm has submitted 24 months long term stability data of three batches conducted at 5 oC + 3 o C and 2
months accelerated stability data of three batches conducted at 25oC + 2 o C & 60% + 5%.
 Urdu version of outer carton label has not been submitted.
 Upon communication of above observations vide letter no. F.1-1/2017/PEC-DRAP (AD PEC-II) dated 24-
05-2018, firm has responded as under:

i. The original CoPP mentions Please note that the MA (marketing authorization) granted in
only strength of the applied Greece is for the 2mg/ml concentration and covers all the ampoule
formulation whereas fill sizes.
volume has not been mentioned The Greek MA is attached at for your reference; we have
in CoPP highlighted the relevant sections noting the concentration which is
common, and the relevant ampoule sizes which are approved.
Firm’s claim has been verified from following web-link of Greece
National Organization for Medicines (accessed on 20-06-2018)
wherein marketing authorization mentions the availability of
10ml fill volume of applied formulation.
http://www.eof.gr/web/guest/search;jsessionid=b4588491a21
05ed97925917ef898
ii. USP monograph is available Pharmathen S.A would like to clarify that assay analytical method
for applied formulation, corresponds to the USP assay method for Atracurium besylate. It
whereas firm has applied in should be clarified that, during development of the product, no
house method for assay USP monograph for applied formulation of Cisatracurium was
analysis. Clarification shall be available. Thus, Pharmathen adopted the assay method described
submitted in this regard. in USP monograph for similar product “Atracurium besylate”. The
method has been fully validated according to the ICH guidelines
on analytical method validation
iii. Firm has submitted 24 months Kindly note that all necessary information can be found in the
long term stability data of three stability summary in 32p81 (Annex C)“the stability is completed
batches conducted at 5°C± 3°C up to 24 months for normal conditions. However, the stability
and 2 months accelerated study for accelerated conditions (up to 6 months) has ended at 2
stability data of three batches months as impurity C2 was out of specifications”. Thus the
conducted at 25°C±2 °C & product has been studied only under long term conditions. Storage
60% ± 5%. Complete 6 months conditions will be declared for the product. On the basis of the 24-
accelerated stability data for month real time stability testing shelf life of 24 months is
three batches shall be predicted when stored in a refrigerator at 2-8°C.
submitted.
iv. Urdu version of outer carton Submitted
label has not been submitted.
Decision: Approved as per policy of inspection of manufacturers abroad
b. New Cases (Veterinary)
Evaluator PEC-XI
927. Name and address of Applicant M/s Mehran International, 498-C, Feroz Shah Mehta Road, Karachi.
Detail of Drug Sale License Address: M/s Mehran International,
498-C, Feroz Shah Mehta Road, Karachi.
Name and address of M/s Hebei New Century Pharmaceutical Co., Ltd. No.189 Taihang
manufacturer Street Hi-tech Zone Shijiazhuang City, Hebei China.
Name and address of marketing M/s Hebei New Century Pharmaceutical Co., Ltd. No.189 Taihang
authorization holder Street Hi-tech Zone Shijiazhuang City, Hebei China
Brand Name +Dosage Form + Long active Ivermectin injection 2%
Strength
Ivermectin……. 20mg
Target Species (for camel, cattle, sheep and swine use)
Pharmacological Group Antiparasitic drug
Shelf life 3 years
Demanded Price De-controlled
Pack size 50ml glass vial
International availability -
Me-too status Ivermectin Plus Injection of Cherished Pharmaceuticals (Pvt) Ltd.,
Lahore.(Reg#058792)
Detail of certificates attached  OriginalLegalized CoPP (certificate no. 2016030521) issued by
Shijiazhuang Animal Husbandry and Aquatic Product Bureau
confirms the free sale of the product in exporting country. The
facilities and operations conform to GMP as recommended by
WHO as per CoPP. The certificate remains valid until 04-03-2021
Decision: Approved.
Brand Name +Dosage Form + Sulfadiazine 40% and Trimethoprim 8% injection
Strength
Sulfadiazine……. 400mg
Trimethoprim……. 80mg
Target Species (for calves, sheep, goats, poultry and swine use)
Finished Product Specification Manufacturer’s specification
Pharmacological Group Sulfadiazine: Sulfonamide antibacterial.
Trimethoprim: Dihydrofolate reductase inhibitor
Shelf life 3 years
Me-too status Trimdiazine Injection of M/s Elko Organisation (Pvt) Ltd Karachi
(Reg # 018457)
Detail of certificates attached OriginalLegalized CoPP (certificate no. 2016030524) issued by
facilities and operations conform to GMP as recommended by WHO
as per CoPP. The certificate remains valid until 04-03-2021
Remarks of the Evaluator. Firm has claimed manufacturer’s specifications while the official
monograph of applied formulation exists in USP.
Brand Name +Dosage Form + Flunixin Meglumine 5% injection
Strength
Flunixin meglumine……. 50mg
Target Species (for horse, cattle, dog and swine use)
Shelf life 3 years
Me-too status Fluxin Injection 50mg/ml Of M/S. Mallard

Pharmaceutical
confirms the free sale of the product in exporting country. The facilities
and operations conform to GMP as recommended by WHO as per
CoPP. The certificate remains valid until 04-03-2021
Remarks of the Evaluator.  Firm has submitted 6 months accelerated stability study data
of batch 12110901, 12110902 and 12110903 manufactured in
November 2012, while firm has submitted real-time stability
study data for 36 months of 3 batches 12110501, 12110502
and 12110503 (as per Zone IV-A).
Decision: Approved.
930. Name and address of Applicant M/s Mehran International,498-C, Feroz Shah Mehta Road, Karachi.
Brand Name +Dosage Form + Imidocarb dipropionate injection 12%
Strength
Imidocarb dipropionate ……. 120mg
Target Species (for horse, cattle, calves, dog and sheep use)
Pharmacological Group Antiprotozoal agent
Shelf life 3 years
Me-too status Imipro Injection of M/s Selmore Pharmaceuticals (Reg.#

029610)
facilities and operations conform to GMP as recommended by WHO
as per CoPP. The certificate remains valid until 04-03-2021
Brand Name +Dosage Form + Diminazine and Antipyrine granules for injection
Strength
Composition Each 2.36g bag contains:
Diminazene ……. 1.050gm
Antipyrine ……. 1.31gm
Target Species (for horse, cattle and sheep use)
Pharmacological Group Antiprotozoal agent
Shelf life 3 years
Pack size 2.36g
Me-too status Diminol powder for injection of M/s Star Labs Lahore (Reg.#
017066)
Decision: Registration Board referred the case to Expert Working Group on Veterinary drugs for
review of formulation
Brand Name +Dosage Form + Nitroxynil injection 34%
Strength
Nitroxynil ……. 340mg
Target Species (for cattle and sheep use)
Pharmacological Group Antihelmintic agent
Shelf life 3 years
Pack size 1x100ml glass bottle
Me-too status Troxy-34% injection of M/s Selmore Pharmaceuticals (Reg.#
034597)
Brand Name +Dosage Form + Oxytetracycline injection 20%
Strength
Oxytetracycline ……. 10gm
Target Species (for calves, dogs, cats, non-lactating dairy cattle, beef cattle, swine,
fish and poultry use)
Pharmacological Group Tetracycline antibiotic
Shelf life 3 years
Me-too status Nawacin L.A. injection of M/s Nawan Labs Karachi (Reg.#
020800)
Remarks of the Evaluator. Firm has submitted 6 months accelerated stability study data of batch
12052301, 12052302, and 12052303, manufactured in May 2012,
while firm has submitted real-time stability study data for 36 months
of 3 batches 12052201, 12052202 and 12052203 (as per Zone IV-A).
Decision: Approved.
Evaluator PEC-V
934. Name and address of Applicant M/s. Aves Care, P-98/54, Gali No.3, Imdadia Street, AlFayyaz
Colony, Satiana Road, Faisalabad.
Detail of Drug Sale License Address: M/s. Aves Care, P-98/54, Gali No.3, Imdadia Street,
AlFayyaz Colony, Satiana Road, Faisalabad.
Name and address of manufacturer M/s Cenavisa, S.L. Cami Pedra Estela, s/no, Reu, 43205 Tarragona,
Reus/Spain.
Name and address of marketing M/s Cenavisa, S.L. Cami Pedra Estela, s/no, Reu, 43205 Tarragona,
authorization holder Reus/Spain.
Name of exporting country Spain
Brand Name +Dosage Form + Strength Cenflox 200 Oral Solutionfor administration in drink water
Composition Enrofloxacin…200mg/ml
Finished Product Specification Innovator
Shelf life 3 years
Demanded Price Rs. 2000.00/L
Pack size 1 Liter and 5 Liter HDPE bottles
International availability Spain
Me-too status Enrox-20% Liquid (026523)
By Xenon Pharmaceuticals (Pvt) Ltd Lahore
Certificate No.:
Certified by: Agencia espanola De Medicamentos Y Productos
Sanitarios, Spain
Issued on: 31/05/2016
Free sale in exporting country : Yes
GMP: Facilities and operations conform to GMP as recommended
by WHO
 GMP Certificate
Certificate No.: ES/177HV/15
Certified by: Agencia espanola De Medicamentos Y Productos
Sanitarios, Spain
Inspection date: 01/07/2015
Validity: 3 years
Remarks of the Evaluator. Target Specie
Chicken and Turkeys
Withdrawal Period
Chickens: Meat and Offal: 7 days
Turkeys: Meat and Offal: 13 days
Shortcoming:
COPP No. of certificate missing.
Previously, firm has submitted stability data at intermediate
condition i.e. 30ºC/65%RH. upto 12 months according to defined
stability protocol. When the firm was communicated to submit
data upto shelf life i.e. 36 months. Firm revised their protocol and
extended same data of 12 months upto 36 months.
 Valid drug sale license.
 Supporting documents like chromatograms, raw data sheets etc for submitted stability data at
30ºC/65%RH upto shelf life i.e. 36 months.
 Submission of original legalized COPP mentioning the certificate number.
935. Name and address of Applicant M/s Huzaifa International, Commercial area, Aziz Bhatti, Town
Sargodha Pakistan.
Detail of Drug Sale License Address: M/s Huzaifa International, A-E Commercial Area Aziz
Bhatti Ton Sargodha
Status: License to sell drugs as a distributor
Name and address of manufacturer M/s KOMIPHARM International Co. Ltd., 17, Gyeongje-RO,
Siheung-SI, Gyeonggi-DO, The Republic of Korea.
Name and address of marketing M/s KOMIPHARM International Co. Ltd., 17, Gyeongje-RO,
authorization holder Siheung-SI, Gyeonggi-DO, The Republic of Korea.
Name of exporting country Korea
Diary No. & Date of R& I Dy. No.18 Dated 02/07/2015 DUPLICATE
Fee including differential fee Rs. 100,000/- Dated 02/07/2015 DUPLICATE
Brand Name +Dosage Form + Strength KOMICALCIVIT Oral Powder
(for poultry, sheep, cattle and horse)
Composition Each 1KG contains:
Calcium carbonate (……………….. 300g
Vitamin A ………………………... 1,600,000 IU
Vitamin D3 ………………………… 300,000 IU
Vitamin E………………………....300 IU
Vitamin B12 ……………………….. 1,000 IU
Calcium Pantothenate …………..... 800 mg
Manganese sulfate……………………….. 4,500 mg
Zinc sulfate ………………………. 7,800 mg
Ferrous sulfate …………………… 4,000 mg
Cobaltous sulfate ……………….... 150 mg
Cupric sulfate ……………………. 250 mg
Dibasic potassium phosphate ……. 350 mg
Pharmacological Group Nutritional supplement
Pack size 1 kg sachet
International availability Cannot be confirmed
Me-too status Cannot be confirmed
Detail of certificates attached  Copy of free sale certificate certified by Animal and Plant
Quarantine Agency of the Ministry for Agriculture food and rural
affairs, Korea on 22/12/2014 is attached, which confirms the free
sale of the product in exporting country.
 Copy of GMP certificate
 Copy of Authority Letter
Remarks of the Evaluator.  Stability studies (long term & Accelerated) according to
the conditions of zone IV-A should be submitted.
Different content of Vitamin A in stability studies i.e.
1600 I.U).
 Address on GMP 235-24 Chusa-Ro , Sinam-Myeon
,Yesan-Gun, Chuncheongnam-Do ,South Korea involved
in manufacturing in of oral powders, is different then on
Form 5.
 Urdu version of label not provided.
 Submission of stability data as per Zone IV A condition of applied formulation as the provided
data mentions different content of Vitamin A i.e. 1600 I.U in stability studies.
 Clarification regarding address of manufacturing site as address mentioned on Form 5 A is
different then GMP certificate.
 Submission of
 Urdu version label.
 Submission of original legalized COPP.
Evaluator PEC-XIV
936. Name and address of Applicant M/s Prix Pharmaceutica, 26 Abbot Road, Lahore 54000
Detail of Drug Sale License Address:M/s Prix Pharmaceutica, 26 Abbot Road, Lahore 54000.
Validity:06-06-2018
Name and address of manufacturer M/s FATRO S.p.A. Via Emilia, 285-40064, Ozzano Emilia
(Bologna), Italy
Name and address of marketing -do-
Brand Name +Dosage Form + TOLEVIT 10 PLUS SE Feed premix
Strength
Composition 1ml of product contains:
Vitamin E (as acetate)……………100mg
Sodium selenite…………………..0.5mg
Pharmacological Group Vitamin and mineral combination
Shelf life 2 years
Pack size 1L bottle, 5L tank
International availability Could not be confirmed.
Me-too status V-set Injection of M/s. Breeze Pharma (Reg # 059164)
Detail of certificates attached Free sale certificate
Free sale certificate states that the premixes of feed additives are not
subject to authorization in the EU provided that they contain additives
authorized under regulation 1831/2003/CEE. Therefore, this product
does not need authorisation and may be considered free sale product.
Certificate of GMP compliance
Certificate No: NBF/12/2014/V
The competent authority of Italy confirms that from the knowledge
gained during inspection of this manufacturer, the latest of which
conducted from 20-02-2017 to 23-02-2017 it is considered that it
complies with Good Manufacturing practice requirements.
Remarks of the Evaluator.  The firm has claimed In House specifications and the product is
not present in BP or USP.
 The firm has submitted 24 months real time stability data sheets
(30oC±2 oC/65%±5%RH) and accelerated stability data sheet
(40oC±2 oC/75%±5%RH) for six commercial batches.
 The time points selected for real time stability studies were 0, 3,
6, 9, 12, 18, 24 months and for accelerated stability studies were
0, 3, 6 months.
Decision: Deferred for free sale status of applied product in the country of origin.
937. Name and address of Applicant M/s Prix Pharmaceutica, 26 Abbot Road, Lahore 54000
Detail of Drug Sale License Address:M/s Prix Pharmaceutica, 26 Abbot Road, Lahore 54000.
Validity:06-06-2018
Name and address of manufacturer M/s FATRO S.p.A. Via Emilia, 285-40064, Ozzano Emilia
(Bologna), Italy
Name and address of marketing -do-
Brand Name +Dosage Form + FATROXIMIN DRY COW Intramammary Ointment
Strength
Composition One 5ml intramammary syringe contains:
Rifaximin……………..100mg
Pharmacological Group Antibacterials for intramammary use
Shelf life 3 years
Pack size Box containing sixty 5-ml syringes
International availability Fatroximin Ointment syringe pump of Fatro Italy (Republica
Italiana)
Detail of certificates attached Legalized CoPP (certificate no. 182/2016/C) certified by Ministero
della Salute issued on 15/07/2016 confirms the free sale of the
product in exporting country. The facilities and operations conform
Remarks of the Evaluator.  The firm has claimed In House specifications and the product is
not present in BP or USP.
 The firm has submitted 24 months real time stability data sheets
(30oC±2 oC/65%±5%RH) and accelerated stability data sheet
(40oC±2 oC/75%±5%RH) for six commercial batches.
 The time points selected for real time stability studies were 0, 3,
6, 9, 12, 18, 24, 36 months and for accelerated stability studies
were 0, 3, 6 months.
 No withdrawal times are required either for the milk or meat of
treated animals.
Evaluator PEC-IV
938. Name and address of Applicant M/s Al-HAMD Poultry & Livestock Services 31-U Khuda Buksh
Colony Lahore Cantt. Lahore Pakistan
Detail of Drug Sale License Address:31-U Block Khuda Buksh Colony New Air Port Road,
Lahore Cantt
Validity : 19/05/2019
Status: drug to sell drugs in a distributor
Name and address of manufacturer M/s ANDRES PINTALUBA, S.A.
Pol. Ind. Agro- Reus. C/Prudenci Betrana no 5 C.P. 43206 Reus
(Tarragona) Spain
Name and address of marketing M/s ANDRES PINTALUBA, S.A.
authorization holder Pol. Ind. Agro- Reus. C/Prudenci Betrana no 5 C.P. 43206 Reus
(Tarragona) Spain
Diary No. & Date of R& I Dy No : 9620 Dated : 21/07/2017
Fee including differential fee Rs : 1,00,000 Dated : 21/07/2017
Brand Name +Dosage Form + APASOL AMOXICILLIN 500
Strength Oral Soluble Powder
(Powder for use in drinking Water)
Composition Each gram of powder contains :
Amoxicillin trihydrate …………...........500mg
(Equivalent to 435.6mg amoxicillin)
(Chickens, turkeys, ducks)
Shelf life 2 Years (As packaged for sale)
1 month (After first opening the immediate packaging)
24 hours (After dilution or reconstitution)
Pack size 500gm, 1Kg,
International availability AMOXICILLIN GLOBAL VET HEALTH 500 by M/s
Vetsonic Ltd UK, VMD UK Approved
Me-too status Amosel-50 Oral Dry Powder M/S. Selmore Pharmaceuticals
Detail of certificates attached Valid and Legalized CoPP
Certified by: AGENCIA ESPANOL DE MEDICAMENTOS Y
PRODUCTOS SANITARIOS DEPARTMENTO DE
MEDICAMENTOS VETERINARIOS parquet empresarial “ LAS
MERCEDES” Edificio 8 c/ Campezo, 1 – 28022 Madrid
Issued on : 15/03/2017
Free sale: Confirms the free sale of the product in exporting country.
GMP certificate
The facilities and operations conform to GMP as
recommended by WHO as per CoPP.
Decision: Approved as per Policy for inspection of Manufacturer abroad

939. Name and address of Applicant M/s Al-HAMD Poultry & Livestock Services 31-U Khuda Buksh
Colony Lahore Cantt. Lahore Pakistan
Detail of Drug Sale License Address:31-U Block Khuda Buksh Colony New Air Port Road,
Lahore Cantt
Validity : 19/05/2019
Status: drug to sell drugs in a distributor
Name and address of manufacturer M/s ANDRES PINTALUBA, S.A.
Pol. Ind. Agro- Reus. C/Prudenci Betrana no 5 C.P. 43206 Reus
(Tarragona) Spain
Name and address of marketing M/s ANDRES PINTALUBA, S.A.
authorization holder Pol. Ind. Agro- Reus. C/Prudenci Betrana no 5 C.P. 43206 Reus
(Tarragona) Spain
Diary No. & Date of R& I Dy No : 9617 Dated : 21/07/2017
Fee including differential fee Rs : 1,00,000 Dated : 21/07/2017
Brand Name +Dosage Form + APSASOL DOXYCYCLINE 500
Strength Oral Soluble Powder
(Powder for use in drinking Water)
Composition Each gram of powder contains :
Doxycycline (Hyclate)…………...........500mg
(Poultary, Swine, Calves)
Finished Product Specification Inhouse Specifications
Shelf life 3 Years (As packaged for sale)
1 month (After first opening the immediate packaging)
24 hours (After dilution or reconstitution)
Pack size 200gm, 500gm, 1Kg,
International availability Altidox powder for use in drinking water by M/s Dechra
Veterinary Products Ltd, Dechra Veterinary Products Ltd, UK
Approved
Me-too status Wealdox Forte Powder Of Mallard Pharmaceuticals
Detail of certificates attached Valid and Legalized CoPP
Certified by: AGENCIA ESPANOL DE MEDICAMENTOS Y
PRODUCTOS SANITARIOS DEPARTMENTO DE
MEDICAMENTOS VETERINARIOS parquet empresarial “ LAS
MERCEDES” Edificio 8 c/ Campezo, 1 – 28022 Madrid
Issued on : 15/03/2017
Free sale: Confirms the free sale of the product in exporting country.
GMP certificate
The facilities and operations conform to GMP as
Deferred Cases
i. Human
Evaluator PEC-V
940. Name and address of Applicant M/s Helix Pharma (pvt.) Ltd.
Hakimsons House.A/56, S.I.T.E Manghopir Road, Karachi
Detail of Drug Sale License Address: Helix pharma (pvt) Ltd., Hakim sons house A-56, S.I.T.E.
Karachi
Status: Drug sale license by the way of whole sale
Name and address of manufacturer M/s Celon Laboratories private limited, Plot no. 2, ALEAP
Industrial Estate, Gajuramaram, Ranga Reddy Dist-500 090,
Telangana, India
Name and address of marketing M/s Celon Laboratories private limited, Plot no. 2, ALEAP
authorization holder Industrial Estate, Gajuramaram, Ranga Reddy Dist-500 090,
Telangana, India
Brand Name +Dosage Form + Bleocel 15 Injection 15 units
Strength Lyophilized powder for solution for injection
Bloemycin sulfate Eq. to Bleomycin activity……… 15 units
Pharmacological Group Antineoplastic, Cytotoxic Antibiotic ATC Code: L01DC01
Pack size 1’s
International availability Bleomycin for Injection By M/S Fresenius Kabi Canada, Health
Canada Approved.
Me-too status Bleocip by M/s Aj Mirza (reg # 045602) (Imported)
Certificate No. 04371/E(M)/TS/2017/07
Certified by: Drugs control administration, Vengalarao Nagar,
Hyderabad, India
Valid till 26/10/2017:
Free sale in Exporting country: Confirms the free sale of the
product in exporting country.
Remarks of the Evaluator. Storage condition: 2-80C
Previous Decision (279): Deferred for following:
 Submission of valid original legalized CoPP
 Submission of valid DSL of the applicant.
 Original legalized CoPP
Certificate No. 2301/E(M)/TS/2018/02
Certified by: Drugs Control Administration, Vengalarao Nagar, Hyderabad, India
Valid till: 26/10/2019:
Free sale in Exporting country: Confirms the free sale of the product in exporting country.
 Valid DSL
Applied for renewal on 15-01-2018
941. Name and address of Applicant M/s Muller & Phipps Pakistan (Pvt). Ltd.
Uzma Court, Mian Clifton Road, Karachi.
Detail of Drug Sale License Address: M/s Muller & Phipps Pakistan (Pvt). Ltd. Plot No. 208 &
208/I Sector 23 Korangi Industrial area Karachi.
Name and address of manufacturer M/s Fresenius Kabi Austria GmbH Hafnerstrabe 36 8055 GRAZ,
Austria
Name and address of marketing M/s Fresenius Kabi Austria GmbH Hafnerstrabe 36 8055 GRAZ,
authorization holder Austria
Name of exporting country Germany
Brand Name +Dosage Form + AMINOSTERIL N HEPA 8% Infusiona
Strength Solution for IV infusion
L-Isoleucine…………….. 10.40mg
L-Leucine……………….. 13.09mg
L-Lysine monoacetate….. 9.71mg (eq. to L-lysine…….. 6.88mg)
L-methionine……………. 1.10mg
N-acetyl-L-cysteine……... 0.70mg (eq. to L-cysteine…. 0.52mg)
L-phenylalanine…………. 0.88mg
L-threonine………………. 4.40mg
L-tryptophan……………... 0.70mg
L-valine…………………... 10.08mg
L-Arginine………………... 10.72mg
L-histidine………………… 2.80mg
Glycine……………………… 5.82mg
L-alanine…………………… 4.64mg
L-proline…………………… 5.73mg
L-serine…………………….. 2.24mg
Pharmacological Group Amino acids (ATC code: B05BA01)
Demanded Price 1’s×10(500ml) Rs. 7500/- (Unit price Rs. 750)
Pack size 1’s×10(500ml)
International availability Available in Austria as per CoPP
Detail of certificates attached  Original legalized CoPP (certificate No. ROB028) certified by
Bundesamt fur Sichercheit im Gesundheitswesen traisengasse, Austria
issued on 13/06/2016 confirms the free sale of the product in exporting
county. The facilities and operations conform to WHO-GMP.``
Remarks of the Evaluator.  The firm has claimed In House specifications while the product
is not present in USP/BP.
 Me too status of the product cannot be confirmed, however the
product is approved in Austria as per CoPP.
Previous Decision (M- 277)
Registration Board deferred the case for further deliberation on import of the applied product whether it can
be imported from Germany as the product license holder and manufacturer are in Austria.
Fresh Evaluation
Firm has revised Form 5A, as it was typographical mistake and has submitted that the import of the applied
product is from “Austria”.
942. Name and address of Applicant M/s Merck (private) limited 7, Jail road, Quetta.
Name and address of M/s Merck KGaA Frankfurter Strabe 250 64293 Darmstadt, Germany
manufacturer
Name and address of Product M/s Merck Serono GmbH Alsfelder Strabe 17 64289 Darmstadt, Germany
License Holder
Exporting Country Germany
Type of Form Form 5-A (Duplicate Dossier)
Diary No. & Date of R& I Dy. No. Cannot be confirmed
Fee including differential fee (Rs. 15,000/- Dated 26/07/2011) +
(Rs 285,000/- Dated 31/01/2013)
(Copies of challan are attached)
Brand Name +Dosage Form + CONCOR 5 PLUS Film Coated Tablet
Strength
Bisoprolol fumarate…… 5mg
Hydrochlorothiazide….. 12.5mg
Pharmacological Group Anti Hypertensive
Shelf life 5 years
Pack size 14’s
Demanded Price Rs. 165/- per pack of 14’s
Rs. 11.78/- per tablet
Intrnational availability Available in Germany as per CoPP
Me-too status Cannot be confirmed
Decision of 263rd meeting:
Submission of legalized valid COPP.
Confirmation of application diary numbers from record.
Evaluation by PEC:
 Original legalized CoPP (certificate No. DeDQg) issued by Regierungsprasidium Darmstadt II 23.2-
18 1 02 (8) Luisenplatz 2 64283 Darmstadt, Germany on 10/04/2017 confirms the free sale of the product in
exporting country. The facilities and operations conform to GMP as recommended by WHO.
 The firm has claimed In House manufacturing specifications while the product is present in USP.
 Mee to status cannot be confirmed is the same strength.
 Copies of challan are attached.
Decision of 272nd meeting:
Deferred for the following:
 Confirmation of diary numbers from the record
 Confirmation of me too status
Evaluation by PEC:
 The Diary number has been traced from the record.
Diary No. 28/11(R-II) Dated: 28/07/2011
 Me too status could not be confirmed in the same strength, however the applied formulation in the
following strengths,
1. Bisoprolol Fumarate …. 2.5 mg & Hydrochlorothiazide ….6.25 mg
2. Bisoprolol Fumarate ….. 10 mg & Hydrochlorothiazide ….6.25 mg
3. Bisoprolol Fumarate …. 5 mg & Hydrochlorothiazide ….6.25 mg
4. Bisoprolol Fumarate .…10 mg & Hydrochlorothiazide…. 12.5mg
Previous Decision(M-274):
Deferred for the the expert opinion (Major General Dr. Tahir Mukhtar).
Evaluation by PEC
Concor 5 Plus Film Coated Tablet is a safe drug and has been tested across various countries and found to be
efficacious in a strength of Bisoprolol fumarate…… 5mg Hydrochlorothiazide…..12.5mg
Drug sale license is required.
Decision: Deferred for following reasons:
 Submission of approval letter for change of title of firm.
 Submission of revised Form 5A as the firm title has changed from Merck to Martin Dow.
 Submission of revised agreement.
 Submission of valid drug sale license.
ii. Veterinary
Evaluator PEC-V
943. Name and address of Applicant M/s Eli Lilly Pakistan (Private) Limited 5-A, 5th floor, Al-Tijarah
Centre, 32-1-A, Block 6, PECHs, Main Shahra-e-Faisal, Karachi.
Detail of Drug Sale License Address: Eli lilly Pakistan (PVT) LTD. 5-A, 5th floor 10th building
floor, Al-Tijarah centre 32-1-A Block 6 PECHS Karachi
Status: Drug license by way of whole sale
Name and address of manufacturer M/s Elanco Animal Health, a division of Eli Lilly and Company, 10500
S. state Road 63, Clinton, Indiana (IN) 47842, United States (USA)
Name and address of marketing M/s Elanco Animal Health, a division of Eli Lilly and Company, 2500
authorization holder Innovation way, Greenfield, Indiana 46140
Name of exporting country USA
Brand Name +Dosage Form + RUMENSIN 200 Medicated Feed
Strength (for Cattles/dairy cows)
Composition Each kg contains:
Monensin (as sodium)…… 200 g
Pharmacological Group Anticoccidial and usereducesd severity of ketosis syndrome
Shelf life 2 years
Pack size 25 kg pack
International availability Rumensin™ 90 by M/s Elanco US INC., USFDA Approved
Me-too status Elancoban 200kg premix by M/s Eastern Agencies (Reg # 013729)
Detail of certificates attached Original legalized CoPP (certificate No. V2015-1014) certified by
USFDA valid till 28/07/2017 confirms the free sale of the product in
exporting country. The facilities and operations conform to GMP as
Decision: Deferred for submission of valid legalized CoPP.
Fresh Evaluation:
The firm has submitted original, legalized and valid CoPP (Certificate No. V2018-172) issued by USFDA
on 12/12/2017 which confirms the free sale of the product in exporting country. The facilities and operations
conform to GMP as recommended by WHO.
Previous Decision (M-278):
Deferred for confirmation of intended use of applied formulation.
Fresh Evaluation:
Firm has submitted the following reply:
It is a Type A medicated article to be used in the manufacture of Type B and C medicated feeds.
According to US Code of Federal Regulation;
"Type A medicated article" is intended solely for use in the manufacture of another Type A medicated article
or a Type B or Type C medicated feed. It consists of a new animal drug(s), with or without carrier (e.g.,
calcium carbonate, rice hull, corn, gluten) with or without inactive ingredients. The manufacture of a Type A
medicated article requires an application approved under 514.105 of this chapter or an index listing granted
under 516.151 of this chapter.
Indications
For increased rate of weight gain; for prevention and control of coccidiosis due to Eimeria bovis and Eimeria
zuernii in growing cattle on pasture or in dry lot (stocker and feeder cattle and dairy and beef replacement
heifers).
Effect of Supplement
This supplement provides for the reduction in the minimum concentration of monensin
in Type C medicated feed s for growing cattle on pasture or in dry lot (stocker and feeder cattle and dairy
and beef replacement heifers) from 25 to 15 grams per ton.
(USFDA)
Case No. 06: Registration applications of drugs for which stability study data is required to be
verified
a. Onsite Verification of Stability Data

Evaluator PEC-VII
Sr. Name & Address Brand Name Type of Form, International Previous DRB
No. of Manufacturer / (Proprietary Name + Initial Diary & Availability / Decision / Remarks
Applicant Dosage Form + Date, Fee Local (if any)
Strength), (including Availability
Composition, differential fee),
Pharmacological Demanded Price GMP
Group, / Pack size Inspection
Finished Product Report Date &
Specification Remarks
944. M/s Vision Dexilans 30mg capsule Form 5-D USFDA The firm has claimed
Pharmaceuticals Approved Manufacturer’s
Plot #22-23, Each capsule contains: Dairy No. 52 Specifications.
Industrial triangle, dated 7-07-2017 Firm was issued
kahuta road, Dexlansoprazole dual GMP Certicate
Islamabad. delayed release pellets Rs.30,000, 13-6- only for the
eq to 2017 Pellets/Lyophiliz
Dexlansoprazole……… Rs.20,000 18-8- ation section. The
……30mg 2016 certificate is
based on the
Proton Pump Inhibitor 3x10’s in ALu inspection
Alu packing conducted on 26-
As per SRO 1-2018.
STABILITY STUDY DATA
Drug Dexilans capsule 30mg
Name of Manufacturer M/s Vision Pharmaceuticals, Islamabad
Manufacturer of API M/s Vision Pharmaceuticals, Islamabad
API Lot No. DLP155T
Description of Pack Alu/Alu Blister packing
(Container closure system)
Stability Storage Condition Accelerated: 40°C ± 2°C & 75±5%RH Real Time: 30°C ± 2°C & 65±5%RH
Time Period Accelerated: 6Months Real Time: 18 Months
Frequency Accelerated: 0,3,6(Months)
Real Time: 0,3,6,9,12,18(Month)
Batch No. NPD607(T-01) NPD607(T-02) NPD607(T-03)
Batch Size 250gm 250gm 250gm
Manufacturing Date 07-2016 07-2016 07-2016
Date of Initiation 07-2016 07-2016 07-2016
No. of Batches 03
Date of Submission Dairy No. 12551 dated 5-04-2018
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr. Documents To Be Provided Status
1. COA of API Copy of COA from M/s Vision Pharmaceutical, Islamabad is
submitted.
2. Approval of API by regulatory authority of
country of origin or GMP certificate of API
manufacturer issued by regulatory authority of
country of origin.
3. Protocols followed for conduction of stability Yes
study 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.
API is manufactured by the firm itself.
6. All provided documents will be attested (name, Yes

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 6Months Accelerated and 18 Months Real Time Stability Data for 03 Batches.
 Firm has conducted dissolution testing at both 5.5 and 7pH for finished product and API.
No. of Manufacturer / (Proprietary Name + Initial Diary & Availability / Decision / Remarks
Applicant Dosage Form + Date, Fee Local (if any)
Strength), (including Availability
Pharmacological Demanded Price GMP
Group, / Pack size Inspection
Finished Product Report Date &
Specification Remarks
945. M/s Vision Dexilans 60mg capsule Form 5-D USFDA The firm has claimed
Pharmaceuticals Approved Manufacturer’s
Plot #22-23, Each capsule contains: Dairy No. 53 Specifications.
Industrial triangle, dated 7-07-2017
kahuta road, Dexlansoprazole dual Firm was issued
Islamabad. delayed release pellets Rs.30,000, 13-6- GMP Certicate
eq to 2017 only for the
Dexlansoprazole……… Rs.20,000 18-8- Pellets/Lyophiliz
…….……60mg 2016 ation section. The
certificate is
Proton Pump Inhibitor 3x10’s in ALu based on the
Alu packing inspection
As per SRO conducted on 26-
1-2018.
Drug Dexilans capsule 60mg
Name of Manufacturer M/s Vision Pharmaceuticals, Islamabad
API Lot No. DLP155T
Stability Storage Condition Accelerated: 40°C ± 2°C & 75±5%RH
Real Time: 30°C ± 2°C & 65±5%RH
Time Period Accelerated: 6Months
Real Time: 18 Months
Frequency Accelerated: 0,3,6(Months)
Real Time: 0,3,6,9,12,18(Month)
Batch No. NPD608(T-01) NPD608 (T-02) NPD608(T-03)
Batch Size 250gm 250gm 250gm
No. of Batches 03
submitted.
2. Approval of API by regulatory authority of Yes
country of origin.
API is manufactured by the firm itself.

sign and stamp) for ensuring authenticity of
data / documents.
Rules, 1978.
 The firm has provided 6Months Accelerated and 18 Months Real Time Stability Data for 03 Batches.
 Firm has conducted dissolution testing at both 5.5 and 7pH for finished product and API.
Report on investigation of genuineness / authenticity of data submitted for registration of Dexilans 30mg capsule and
Dexilans 60mg capsule of M/s Vision Pharmaceuticals Plot #22-23, Industrial triangle, kahuta road, Islamabad.
Reference No: F.13-11/2017-PEC dated 30th April, 2018.
Investigation Date and Time: 1st June, 2018 (Morning)
Investigation Site: Factory premises of M/s Vision Pharmaceuticals
Background:
M/s. Vision Pharmaceuticals, Islamabad have applied for registration of Dexilans 30mg capsule and Dexilans
60mg capsule (Dexlansoprazole). PEC considered scientifically rational laboratory scale data submitted by the firm
as pre-requisite of registration, So the chairman Registration board has 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.
Composition of Panel:
1. Dr. Qurban Ali, (Member Registration Board)
2. Mr. Abdullah, Additional Director, DRAP, Islamabad
3. Mst Sidra Khalid (Assistant Director, PE& R Division, DRAP)
Scope of investigation:
Investigation to confirm genuineness / authenticity of stability data and associated documents, import of API,
quality, specification, test analysis, facilities etc.
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:
a. General Information.
Name of Manufacturer M/s Vision Pharmaceuticals
Physical Address Plot #22-23, Industrial triangle, kahuta road, Islamabad.
Drug Manufacturing License No. and validity 0005517, Issued on 1-4-2014 (validity 5 year)
Contact Address Dr. Zia-ud-din
Chief operating officer/Director Technical
Date of Inspection. 1-06-2018
Purpose of Inspection Verification of Authenticity of Stability Data for Purpose

of Registration of Drugs with reference DRAP’s Letter
No. F.13-11/2017-PEC dated 30th April, 2018.
Name of firm Representatives ● Dr. Zia-ud-din
Chief operating officer/Director Technical
● Humera Iqbal,
QC Manager
● Mr. M. Adnan
Assistant Manager QC
● Aatikah Younis
Manager R&D
● M. Mudassar Ali
R&D Officer
● Laila tul Qadar
R&D Officer
1.3 Focus of Inspection:

The inspection was focused on a thorough evaluation of data for stability studies of following products
namely:
Sr. Name of Firm Name of Drug a d Composition

1. M s Vision Pharma Plot# 22- Dexilans 30 mg capsule
23, indus rial triangle Kahuta Each Capsule contains:
Road, Islamabad Dexlansoprazole dual release pellets eq to Dexlansoprazole...
30 mg
Dexilans 60 mg capsule
Each Capsule contains:
Dexlansoprazole dual release pellets eq to Dexlansoprazole...
60 mg
Panel visited the R&D Laboratory and Quality Control Laboratory of the firm. Panel also visit the whole
Premises of factory including palletization and lyophilization section. The data was evaluated according to the check
list provided as given below:
Detail of investigation:
1. Dexilans 30 mg capsule
&
2. Dexilans 60 mg capsule
Q.No. Question Observation by panel
1. Do you have documents confirming The firm used pellets made by their own semi basic plant “M/s
the import of API including approval Vision Pharmaceuticals” purchased through invoice # 423.
from DRAP? The quantity of dexlansoprazole raw material obtained was 1.5
Kg from M/s Vision Pharmaceuticals.
2. What was the rationale behind Vendor Selection for pellets:
selecting the particular manufacturer Firm informed that they are them self-sole manufacturer of
of API? Dexlansoprazole pellets that has release pattern similar to that
of innovator source. Furthermore they claimed that they are
the big exporter in the country and exporting every month in
tons. So they select them self as API manufacturer.
Vendor Selection of Dexlansoprazole Powder for
palletization:
The firm also has internal criteria for selection 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.
For API Powder: the firm has already importing some of its
APIs from quite long from Everest Pharma India, and has
never faced issues with quality, documentation and
availability of the API. Therefore the sources was selected.
3. Do you have documents confirming Firm imported Dexlansoprazole
the import of API reference standard working standard (100 mg), Batch # DLP/WS-01/16
and impurity standards? Impurity standard (25 mg) Batch # LNS/WS-01/15 from
Everest organics limited India through distributor Neon
Chemicals Lahore.
Firm informed that working standard was imported from the
same source as that of Dexlansoprazole powder.
4. Do you have certificate of Analysis of The firm had certificates of analysis for
the API, reference standards and API pellets:
impurity standards? Batch # DLP155T,
Quantity: 1.5 kg
Working standard:
Batch #,DLP/WS-01/16
100mg
Impurity standards:
Batch # LNS/WS-01/15, (25 mg)
Batch # LNS/Sulphone/WS-01/15, (25 mg)
5. Do you have GMP certificate of API Firm had provided valid GMP certificate (No. F.8-1/2016-
manufacturer issued by regulatory DDG (E&M)) issued by DRAP Valid up to 25-1-2019
authority of country of origin?
6. Do you use API manufacturer method The firm used API manufacturer’s method of testing
of testing for testing API? Document # QC/SOP/03148 dated 29/10/2015.
7. Do you have stability studies reports The firm had stability studies reports on API of raw material
on API? manufacturer from Vision Pharma.
8. If yes, whether the stability testing has The stability testing had been performed as per SIM method
been performed as per SIM method and degradation products had been quantified. Protocol #
and degradation products have been 03149 dated 29-1-2018 along with SIM reports were present.
quantified?
9. Do you have method for quantifying Firm had testing method (document # QC/SOP/03148) to
the impurities in the API? quantify the impurities as per raw material manufacturer.
10. Do you have some remaining The firm had some remaining quantities of the API (0.27 kg)
quantities of the API, its reference But working standard and impurity standard was all
standard and impurities standards? consumed.
11. Have you used pharmaceutical grade The firm had used ready to fill pellets therefore no other
excipients? excipient has been used. While documents confirming
purchase of gel cap was available.
12. Do you have documents confirming The firm had used ready to fill pellets therefore no other
the import of the used excipients? excipient has been used.
13. Do you have test reports and other The firm had used ready to fill pellets therefore no other
records on the excipients used? excipient has been used.
14. Do you have written and authorized The firm had written and authorized protocols for the
protocols for the development of development of Dexilans 30mg capsule and Dexilans 60mg
applied formulation? capsule.
15. Have you performed Drug-excipient The firm had used ready to fill pellets therefore no other
compatibility studies? excipient has been used.
16. Have you performed comparative ● Firm had presented Comparative dissolution study report.
dissolution studies? The details of reference product & Sample product are as
follows:
Feature Reference product Product of
(Takeda) Vision
Brand name Dexilant Capsule Dexilans
capsule
Batch No. C22622 NPD608-/t-03
● Comparative dissolution studies have been performed in
following mediums:
1. Acidic Stage
 0.1N HCl buffer, 500 ml for 120 min
2. Basic Phase”
 pH 5.5 0.1N HCL
 pH 7 buffer (with SLS)
● The graphical representation of comparative dissolution
shows closely resembling results.
17. Do you have product development The firm had product development (R&D) section
(R&D) section
18. Do you have necessary equipment Product development section had necessary equipment to
available in product development develop products however Dexlansoprazole capsules were
section for development of applied filled in production area.
formulation?
19. Are the equipment in product The available equipment in product development section were
development section qualified? qualified. Documents for installation and operation
qualification was provided.
20. Do you have proper maintenance / The firm has SOP for maintenance / calibration / re-
calibration / re-qualification program qualification program for the equipment used in production
for the equipment used in PD section? and QC used for product development section.
21. Do you have qualified staff in product The firm had 04 pharmacists and 2 Chemist in product
development section with proper development section with suitable knowledge and training in
knowledge and training in product product development.
development?
22. Have you manufactured three stability The firm had manufactured three stability batches for the
batches for the stability studies of stability studies of
applied formulation as required? Dexlansoprazole capsules (30 mg,60 mg) with batch numbers
i.e.
Product Batch 1 Batch 2 Batch 3
Dexilant 30 NPD607 (T- NPD607 (T- NPD607(T-

mg capsules 01), 02), 03)
Dexilant 60 NPD608(T- NPD608 (T- NPD608(T-

mg capsules 01), 02), 03)
The Batch size for these batches is 694 capsule
23. Do you have any criteria for fixing the As per statement of the firm the criteria for fixing the batch
batch size of stability batches? size of stability batches is the number of capsule per testing
frequency and number of testing frequencies.
24. Do you have complete record of The firm had complete record of production of stability
production 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 The firm had detailed protocols (SOR 05035) for stability
testing of stability batches? testing of stability batches.
26. Do you have developed and validated The firm had developed and validated method of testing for
the method for testing of stability finished product based on method of testing of API
batches? manufacturer.The method is gradient mode and stability
indicating and has validated while using the working standard
of API, impurities and forced degradation studies.
27. Do you have method transfer studies in The firm has not conducted method transfer studies, however,
case when the method of testing being they have validated their method.
used by your firm is given by any other
lab?
28. Do you have documents confirming The firm had proper documents confirming the qualification
the qualification of equipment’s / of equipment / instruments being used in the test and analysis
instruments being used in the test and of API and the finished drug.
analysis of API and the finished drug?
29. Do your method of analysis stability Firm had validated testing method which was stability
indicating? indicating.
30. Do your HPLC software 21CFR Firm has multiple HPLCs most of which are now 21 CFR 11.
Compliant? 21CFR complaint HPLC system was used for stability studies
of dexilans capsules at the 18 month time point. The HPLC
used for the stability studies upto 18 months studies, has
software not 21CFR compliant, however the record from
logbooks, analytical test reports was verifiable onsite.
Whereas, the 18 months studies/ testing is carried out on 21
CFR 11 compliant. Stability indicating method (Validation)
was also performed on 21CFR. A complete trail of validation
studies is available and verifiable.
31. Can you show Audit trail reports on Firm had demonstrated audit trail reports (assay & dissolution
applied formulation testing? analysis on HPLC) for the submitted stability batches at only
18 months.However, the previous record was verifiable onsite
only from logbooks, analytical test reports.
32. Do you have some remaining The firm had remaining quantities of stability batches.
quantities of degradation products and T-01: 05 packs
stability batches? T-02: 06 packs
T-03: 06 packs
33. Do you have stability batches kept on The firm had stability batches on stability testing.
stability testing?
34. Do you have valid calibration status The firm had valid calibration status for the equipment used in
for the equipment used in production dexilans capsule production and analysis.
and analysis?
35. Do proper and continuous monitoring Adequate monitoring and control was available for stability
and control are available for stability chamber.Continuous power supply and monitoring with back
chamber? up from generator are available for stability chamber. In case
of load shedding start up time of the generator is within 02
minutes.
36. Do related manufacturing area, Requisite facilities were satisfactory and GMP compliant.
equipment, personnel and utilities be
rated as GMP compliant?
Conclusion /Recommendations:
Based on the area inspected, the technical personnel method, documents reviewed, and considering the
findings of inspection, the panel is of the opinion that the data provided by the firm M/s Vision Pharmaceuticals Plot
#22-23, Industrial triangle, kahuta road, Islamabad regarding stability studies of following products was satisfactory
and the stability studies were conducted by the firm.
Firm had demonstrated audit trail reports (assay & dissolution analysis on HPLC) for the submitted stability
batches at only 18 months.However, the previous record was verifiable onsite from logbooks, analytical test reports.
On the basis of risk based approach the genuineness / authenticity of stability data submitted by the firm for
registration of Dexilans 30 mg and 60 mg capsule is verifiable to satisfactory level.
The related manufacturing area, equipment, personnel and utilities are GMP compliant and well suited for
the manufacturing of Dexilans 30 mg and 60 mg capsule.
Decision: Registration Board decided to approve registration of “Dexilans 30 mg (dexlansoprazole) and
Dexilans 60 mg (Dexlansoprazole) capsule by M/s Vision Pharmaceuticals Plot #22-23, Industrial triangle,
kahuta road, Islamabad. 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-II
Evaluator PEC-XIV
Sr. Name & Address Brand Name Type of Form, International REMARKS
No. of Manufacturer / (Proprietary Name + Initial Diary & Date, Availability / Local (IF ANY)
Applicant Dosage Form + Fee (including Availability
Strength), differential fee),
Composition, Demanded Price / GMP Inspection
Pharmacological Pack size Report Date &
Group, Remarks
Finished Product
Specification
946. M/s Hilton Pharma Grehil 60mg tablets Form 5-D Approved by
(Pvt.) Ltd. Karachi Each film coated tablet Diary No. 760 dated USFDA
contains: 06-05-2016. Not applicable.
Ticagrelor …… 60mg Rs.50,000/- dated 06- Last GMP
(Platelet aggregation 05-2016 inspection was
inhibitor) 20’s, 30’s,60’s conducted on 19-07-
As per DPC 2017 and the report
concludes
satisfactory level of
GMP compliance
STABILITY STUDY DATA SUBMITTED INITIALLY
Drug Grehil 60mg tablets (Ticagrelor)
Name of Manufacturer M/s Hilton Pharma (Pvt.) Ltd. Karachi
Manufacturer of API M/s Nantong Chanyoo Pharmatech Co., Ltd, China
API Lot No. TGL-160301
Description of Pack Alu-Alu blister foil with unit carton
Stability Storage Condition Real Time: 30°C ± 2°C / 65% ± 5%RH
Accelerated: 40°C ± 2°C / 75% ± 5%RH
Time Period Real Time: 6 months
Accelerated: 6 months
Frequency Real Time: 0,3 & 6 (months)
Accelerated: 0,3 & 6 (months)
Batch No. GRE-252607-6 GRE-252607-7 GRE-252607-8
Batch Size 3,500 Tablets 3,500 Tablets 3,500 Tablets
Manufacturing Date 18-07-2017 18-07-2017 18-07-2017
Date of Initiation 22-08-2017 22-08-2017 22-08-2017
No. of Batches 03
Date of Submission 10-05-2018 (Dy. No. 17463)
DOCUMENTS / DATA PROVIDED BY THE APPLICANT INITIALLY
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 of Registration Board
country of origin.
3. Protocols followed for conduction of stability
Yes
4. Data of 03 batches will be supported by attested
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 or analysis) issued by ADC (Karachi)
dated 22-08-2016, for the import of Ticagrelor (1.5 Kg)
from the M/s Nantong Chanyoo Pharmatech Co., Ltd,
China has been submitted.
 Copy of Commercial Invoice (invoice no. CY116195)
dated attested by ADC (Karachi) dated 22-08-2016 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
till assigned shelf life of the product.
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.
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.
AQS/SK/180508-01, dated 08-05-2018 and provided the following documents in conjunction with the checklist
approved by the Registration Board in its 278th Meeting:
(Date of submission: 10-05-2018 vide diary no. 17463)
Administrative Portion
1. Reference of last onsite panel inspection for Firm has referred to onsite inspection report of their
instant dosage form conducted during last two product “HILVEL 400mg + 100mg (Sofosbuvir +
years. Velpatasvir)”, which was conducted on 14th December,
2017 and was presented in 277th meeting of Registration Board
held on 27-29th December, 2017.
Registration Board decided to approve registration of
“HILVEL 400mg / 100mg (Sofosbuvir + Velpatasvir” by
M/s. Hilton Pharma (Pvt.) Ltd., Karachi. Manufacturer will
place first three production batches on long term stability
studies throughout proposed shelf life and on accelerated
studies for six months.
Following two observations were reported in the report:
i. The HPLC software is 21 CFR compliant.
ii. Audit trail on the testing reports of Hilvel Tablets
400mg+100mg is available.
iii. Adequate monitoring and control are available for
stability chamber. Chamber are controlled and monitored
through software having alarm system for alerts as well.
2. Documents for the procurement of API with  Copy of Form 6 (License To Import drug for clinical trial
approval from DRAP (in case of import). examination, test or analysis) issued by ADC (Karachi)
been submitted.
3. Documents for the procurement of reference  The firm has submitted copy of letters from M/s Neon
standard and impurity standards. Chemicals in the name of M/s Hilton Pharma (Pvt.) Ltd,
Karachi, 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
TG-16 -- 20mg
(Impurity)
DE-ETHOXYL -- 20mg
OF TG
(Impurity)
Working WTG01- 100mg
standard 150401
4. Approval of API/ DML/GMP certificate of API Approved source as per decision of 275th meeting of
country of origin.
5. Mechanism for Vendor pre-qualification  The firm has submitted photocopy of “SOP for Selection
of manufacturer for API/Excipient and Procurement
Procedure”,
SOP No: PDV-FM-068 with effective date 02-03-2018.
Version no: 01
 Copy of “Vendor’s Audit form” filled for M/s Nantong
Chanyoo Pharmatech Co., Ltd, China, dated 27-04-2018.
6. Certificate of analysis of the API, reference  Photocopy of COAs of Ticagrelor, working standards and
standards and impurity standards impurity standards issued by M/s Nantong Chanyoo
Pharmatech Co., Ltd, China.is submitted. Detail is as under
Particulars Batch No.

Ticagrelor TGL-160301
TG-16 (Impurity) 201607001-A
DE-ETHOXYL OF 201607001-B
TG (Impurity)
Working standard WTG01-150401
7. Documents for the procurement of excipients used The firm has submitted photocopy of Purchase Order/Invoices
in product development? 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 staff
development with relevant experience. involved in product development & regulatory affairs
comprising of 17 members.
Production Data
9. Authorized Protocols/SOP for the development &  The firm has submitted photocopy of Development
stability testing of trial batches. Protocol for Lab scale batch manufacturing of Grehil 60mg
& 90mg film coated tablets, issued on Jul, 2016. The SOP
mentions the details of master formulation &
manufacturing method for both Grehil 60mg & 90mg
film coated tablets. Copies of stability protocols have also
been submitted for Grehil 60mg & 90mg film coated
tablets.
 The master formulation and manufacturing method
mentioned in development protocol is same as that of
reference product.
10. Complete batch manufacturing record of three The firm has submitted photocopy of Batch Manufacturing
stability batches. Record and Batch Packaging Record of the following 03
Batches:
Batch No. Batch Size Mfg. Date

GRE-252607-6 3500 Tablets 18-07-2017
GRE-252607-7 3500 Tablets 18-07-2017
GRE-252607-8 3500 Tablets 18-07-2017
 As per submitted record all the activities of manufacturing
i.e. dispensing, granulation, drying, compression & coating
has been performed in PD lab.
11. Record of remaining quantities of stability The firm has submitted reconciliation sheet mentioning that
batches. 108 tablets of each of three trial batches are remaining.
QA / QC DATA
12. Record of Digital data logger for temperature and  The firm has submitted photocopies of digital printouts of
humidity monitoring of stability chambers (real graphical chart for Real Time and Accelerated Conditions
time and accelerated) starting from 29-08-2017 to 02-07-2018.
13. Method used for analysis of API along with COA.  The firm has submitted photocopy of raw material
specifications, raw material testing procedures and report
for Ticagrelor (batch #.TGL-160301) along with
chromatograms, FTIR spectrum, lab reports, raw data
sheets & COAs for Ticagrelor from M/s Nantong Chanyoo
Pharmatech Co., Ltd, China
14. Method used for analysis of FPP & complete The firm has submitted photocopy of Finished Product Testing
record of testing of stability batches (i.e. Procedure (PD-FPS/97/00 issued on 17-04-2017) for Grehil
chromatograms, lab reports, raw data sheets etc.) 60mg Tablet along with Stability Study Report of stability
batches.
15. Reports of stability studies of API from The firm has submitted photocopy of 06 Months Accelerated
manufacturer. and 24 Months Real Time Stability Study (25oC+2 oC, 60+5%)
Data of 03 Batches of Ticagrelor from M/s Nantong Chanyoo
16. Analysis reports for excipients used. The firm has submitted photocopies of its own Analytical
reports for all excipients used in product development of Grehil
tablets.
17. Drug-excipients compatibility studies.  The firm has not performed Drug-excipients compatibility
studies and stated that the qualitative composition of their
product (Grehil Tablet) is similar to that of innovator’s
product i.e. Brilinta tablet and also stability studies have
not shown any incompatibility or significant degradation.
18. Record of comparative dissolution data.  Firm has submitted F2 factor protocol (F2# 105) & reports
dated 09-03-2018. The details of reference product &
Sample product are as follows:
Feature Reference Product of

product M/s Hilton
Brand name Brilique 60mg Grehil 60mg
tablet tablet
Batch No. KACA GRE-252807-
8
Expiry date 08-2018 --
 Comparative dissolution studies have been performed in

following mediums:
i. pH 1.2 HCl buffer with 0.2% Polysorbate 80
ii. pH 4.5 Acetate buffer with 0.2% Polysorbate 80
iii. pH 6.8 Phosphate buffer with 0.2% Polysorbate 80
 In pH 1.2 HCl buffer with 0.2% Polysorbate 80 similarity
factory is 71.
 In pH 4.5 Acetate buffer with 0.2% Polysorbate 80
similarity factory is 53.
 In pH 6.8 Phosphate buffer with 0.2% Polysorbate 80
19. Compliance Record of HPLC software 21CFR &  Firm has submitted audit trail reports of stability
audit trail reports on product testing. studies of applied formulation
Sr. Name & Address Brand Name Type of Form, International REMARKS
No. of Manufacturer / (Proprietary Name + Initial Diary & Date, Availability / Local (IF ANY)
Applicant Dosage Form + Fee (including Availability
Strength), differential fee),
Composition, Demanded Price / GMP Inspection
Pharmacological Pack size Report Date &
Group, Remarks
Finished Product
Specification
947. M/s Hilton Pharma Grehil 90mg tablets Form 5-D Approved by
(Pvt.) Ltd. Karachi Each film coated tablet Diary No. 768 dated USFDA
contains: 06-05-2016. Not applicable.
Ticagrelor …… 90mg Rs.50,000/- dated 06- Last GMP
(Platelet aggregation 05-2016 inspection was
inhibitor) 20’s, 30’s,60’s conducted on 19-07-
As per DPC 2017 and the report
concludes
satisfactory level of
GMP compliance
Drug Grehil 90mg tablets (Ticagrelor)
Name of Manufacturer M/s Hilton Pharma (Pvt.) Ltd. Karachi
Manufacturer of API M/s Nantong Chanyoo Pharmatech Co., Ltd, China
API Lot No. TGL-160301
Description of Pack Alu-Alu blister foil with unit carton
Batch No. GRE-252207-11 GRE-252307-12 GRE-252407-13
Batch Size 2333 Tablets 2333 Tablets 2333 Tablets
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
country of origin.
Yes
5. Documents confirming import of API etc.  Copy of Form 6 (License To Import drug for clinical trial
been submitted.
sign and stamp) for ensuring authenticity of data Yes
/ documents.
7. Commitment to continue real time stability study
Yes
Yes
Rules, 1978.

AQS/SK/180508-01, dated 08-05-2018 and provided the following documents in conjunction with the checklist
approved by the Registration Board in its 278th Meeting:
1. Reference of last onsite panel inspection for Firm has referred to onsite inspection report of their
instant dosage form conducted during last two product “HILVEL 400mg + 100mg (Sofosbuvir +
years. Velpatasvir)”, which was conducted on 14th December,
2017 and was presented in 277th meeting of Registration
Board held on 27-29th December, 2017.
Registration Board decided to approve registration of
“HILVEL 400mg / 100mg (Sofosbuvir + Velpatasvir” by
M/s. Hilton Pharma (Pvt.) Ltd., Karachi. Manufacturer will
place first three production batches on long term stability
studies throughout proposed shelf life and on accelerated
studies for six months.
i. The HPLC software is 21 CFR compliant.
ii. Audit trail on the testing reports of Hilvel Tablets
400mg+100mg is available.
iii. Adequate monitoring and control are available for
stability chamber. Chamber are controlled and monitored
through software having alarm system for alerts as well.
2. Documents for the procurement of API with  Copy of Form 6 (License To Import drug for clinical trial
approval from DRAP (in case of import). examination, test or analysis) issued by ADC (Karachi)
been submitted.
3. Documents for the procurement of reference  The firm has submitted copy of letters from M/s Neon
standard and impurity standards. Chemicals in the name of M/s Hilton Pharma (Pvt.) Ltd,
Karachi, 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

TG-16 (Impurity) -- 20mg
DE-ETHOXYL OF TG -- 20mg
(Impurity)
Working standard WTG01- 100mg
150401
4. Approval of API/ DML/GMP certificate of API Approved source as per decision of 275th meeting of
country of origin.
5. Mechanism for Vendor pre-qualification  The firm has submitted photocopy of “SOP for Selection
of manufacturer for API/Excipient and Procurement
Procedure”,
SOP No: PDV-FM-068 with effective date 02-03-2018.
Version no: 01
 Copy of “Vendor’s Audit form” filled for M/s Nantong
Chanyoo Pharmatech Co., Ltd, China, dated 27-04-2018.
6. Certificate of analysis of the API, reference  Photocopy of COAs of Ticagrelor, working standards and
standards and impurity standards impurity standards issued by M/s Nantong Chanyoo
Pharmatech Co., Ltd, China.is submitted. Detail is as under
Particulars Batch No.

Ticagrelor TGL-160301
TG-16 (Impurity) 201607001-A
DE-ETHOXYL OF 201607001-B
TG (Impurity)
Working standard WTG01-150401
7. Documents for the procurement of excipients used

The firm has submitted photocopy of Purchase Order/Invoices
in product development? for the procurement of excipients used in product development
development with relevant experience. involved in product development & regulatory affairs
comprising of 17 members.
Production Data
9. Authorized Protocols/SOP for the development &  The firm has submitted photocopy of Development
stability testing of trial batches. Protocol for Lab scale batch manufacturing of Grehil 60mg
& 90mg film coated tablets, issued on Jul, 2016. The SOP
mentions the details of master formulation &
manufacturing method for both Grehil 60mg & 90mg
film coated tablets. Copies of stability protocols have also
been submitted for Grehil 60mg & 90mg film coated
tablets.
 The master formulation and manufacturing method
mentioned in development protocol is same as that of
reference product.
Batches:
GRE-252207-11 2333 Tablets 15-07-2017
GRE-252307-12 2333 Tablets 15-07-2017
GRE-252407-13 2333 Tablets 15-07-2017
 As per submitted record all the activities of manufacturing
i.e. dispensing, granulation, drying, compression & coating
has been performed in PD lab.
11. Record of remaining quantities of stability The firm has submitted reconciliation sheet mentioning that
batches. 108 tablets of each of three trial batches are remaining.
QA / QC DATA
12. Record of Digital data logger for temperature and  The firm has submitted photocopies of digital printouts of
humidity monitoring of stability chambers (real graphical chart for Real Time and Accelerated Conditions
time and accelerated) starting from 29-08-2017 to 02-07-2018.
13. Method used for analysis of API along with COA.  The firm has submitted photocopy of raw material
specifications, raw material testing procedures and report
for Ticagrelor (batch #.TGL-160301) along with
chromatograms, FTIR spectrum, lab reports, raw data
sheets & COAs for Ticagrelor from M/s Nantong Chanyoo
14. Method used for analysis of FPP & complete The firm has submitted photocopy of Finished Product Testing
record of testing of stability batches (i.e. Procedure (PD-FPS/98/00 issued on 17-04-2017) for Grehil
chromatograms, lab reports, raw data sheets etc.) 90mg Tablet along with Stability Study Report of stability
batches.
15. Reports of stability studies of API from The firm has submitted photocopy of 06 Months Accelerated
manufacturer. and 24 Months Real Time Stability Study (25oC+2 oC, 60+5%)
Data of 03 Batches of Ticagrelor from M/s Nantong Chanyoo
16. Analysis reports for excipients used. The firm has submitted photocopies of its own Analytical
reports for all excipients used in product development of Grehil
tablets.
studies and stated that the qualitative composition of their
product (Grehil Tablet) is similar to that of innovator’s
product i.e. Brilinta tablet and also stability studies have
not shown any incompatibility or significant degradation.
18. Record of comparative dissolution data.  Firm has submitted F2 factor protocol (F2# 087) & reports
dated 09-03-2018. The details of reference product &

product M/s Hilton
Brand name Brilique 90mg Grehil 90mg
tablet tablet
Batch No. TDYW/5101 GRE-252207-
11
Expiry date 05-2019

following mediums:
i. pH 1.2 HCl buffer with 0.2% Polysorbate 80
ii. pH 4.5 Acetate buffer with 0.2% Polysorbate 80
iii. pH 6.8 Phosphate buffer with 0.2% Polysorbate 80
 In pH 1.2 HCl buffer with 0.2% Polysorbate 80 similarity
factory is 64.
 In pH 4.5 Acetate buffer with 0.2% Polysorbate 80
 In pH 6.8 Phosphate buffer with 0.2% Polysorbate 80
19. Compliance Record of HPLC software 21CFR &  Firm has submitted audit trail reports of stability studies of
audit trail reports on product testing. applied formulation
Decision: Registration Board decided to approve registration of “Grehil 60mg tablets (Ticagrelor 60 mg) and
Grehil 90mg tablets (Ticagrelor 90mg) by M/s Hilton 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
948. Name and address of manufacturer / M/s Sami Pharmaceuticals (Pvt.) Ltd. F-95, Off. Hub River
Applicant Road, S.I.T.E., Karachi
Brand Name +Dosage Form + Strength Valsatril 97mg/103mg Tablet
Diary No. Date of R& I & fee Dyn:18441, 21-05-2018, Rs.50,000/- (21-05-2018)
Sacubitril …… 97.2 mg
Valsartan ….…. 102.8 mg
Pharmacological Group Angiotensin II antagonists
Type of Form Form-5
Pack size & Demanded Price As per latest decision taken by DPC in respect of usual/hardship
cases.
Me-too status N/A
good level of GMP compliance.

Drug Valsatril 97mg/103mg Tablet
Name of Manufacturer M/s Sami Pharmaceuticals (Pvt.) Ltd. F-95, Off. Hub River Road, S.I.T.E., Karachi
Manufacturer of API M/s Zhejiang Tianyu Pharmaceutical Co., Ltd. China
API Lot No. L2016014 & L20161102
Description of Pack Alu –Alu blister
Accelerated: 0,1,3,4 & 6 (months)
Batch No. Lab-001 Lab-002 Lab-003
Batch Size 1700 tablets 1700 tablets 1700 tablets
No. of Batches 03
No.
1. COA of API Yes
2. Approval of API by regulatory authority of Copy of GMP certificate (certificate no. ZJ20130111) has been
country of origin or GMP certificate of API submitted for M/s Zhejiang Tianyu Pharmaceutical Co., Ltd. issued
manufacturer issued by regulatory by SFDA, China, and valid upto 12-09-2018.
authority 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
attested respective documents like
Yes
chromatograms, laboratory reports, data
sheets etc.
5. Documents confirming import of API etc.  Copy of Form 6 (License to Import drug for clinical trial
examination, test or analysis) issued by ADC (Karachi) dated
05-01-2017, for the import of Sacubitril-Valsartan sodium
complex (02 Kg) from the M/s Zhejiang Tianyu
Pharmaceutical Co., Ltd. China has been submitted.
 Copy of Commercial Invoice (invoice no. TYI161153) attested
by ADC (Karachi) dated 05-01-2017 has been submitted. Batch
No. L2016014/L20161102
6. All provided documents will be attested
(name, sign and stamp) for ensuring Yes
authenticity of data / documents.
7. Commitment to continue real time stability
Yes
Yes
Rules, 1978.

The firm has requested for Exemption from On-site Investigation of their submitted stability data and provided the
following documents in conjunction with the checklist approved by the Registration Board in its 278th Meeting:
1. Reference of last onsite panel inspection for Firm has referred to onsite inspection report of their product
instant dosage form conducted during last “TONOFLEX-P FORTE 75mg / 650mg (Tramadol HCl +
two years. Paracetamol) Tablets”, which was conducted on 08th January, 2018
and was presented in 278th meeting of Registration Board held on
29-31st January, 2017.

i. The HPLC software is 21CFR Compliant.
ii. Firm has shown all Audit trail reports.
iii. Adequate monitoring and control are available for stability
chambers. Data Loggers are also placed in stability chambers
for monitoring
2. Documents for the procurement of API with  Copy of Form 6 (License to Import drug for clinical trial
approval from DRAP (in case of import). examination, test or analysis) issued by ADC (Karachi) dated
complex (02 Kg) from the M/s Zhejiang Tianyu Pharmaceutical
Co., Ltd. China has been submitted.
No. L2016014/L20161102
3. Documents for the procurement of  Firm has submitted COAs of working/reference standards from
reference standard and impurity standards. M/s Zhejiang Tianyu Pharmaceutical Co., Ltd. China, detailed
as under:
Batch. # Quantity
WRS151201 10 mg
IRS160101 10 mg
IRS160901 10 mg
4. Approval of API/ DML/GMP certificate of Copy of GMP certificate (certificate no. ZJ20130111) has been
API manufacturer issued by regulatory submitted for M/s Zhejiang Tianyu Pharmaceutical Co., Ltd. issued
authority of country of origin. by SFDA, China, and valid upto 12-09-2018
5. Mechanism for Vendor pre-qualification The firm has submitted as under:

 We have selected API supplier on the basis of GMP compliance
and quantifying all tests of COA.
 Meets the criteria of impurity profiling.
 Documented vendor evaluation procedure followed.
 Availability of DMF.
 No relevant document has been submitted in support of
Vendor evaluation procedure.
6. Certificate of analysis of the API, reference  Copies of COAs of API have been submitted, detailed as under:
standards and impurity standards
API Batch. # Quantity
Sacubitril and L2016014 1Kg
valsartan as sodium
salt complex L20161102 1Kg
 Firm has submitted COAs of working/reference standards from

M/s Zhejiang Tianyu Pharmaceutical Co., Ltd. China, detailed
as under:
Batch. # Quantity
WRS151201 10 mg
IRS160101 10 mg
IRS160901 10 mg
7. Documents for the procurement of The firm has submitted commercial invoices & COAs of all the
excipients used in product development? excipients used in formulation of Valsatril 97/103 mg film coated
tablets, from relevant manufacturers.
8. List of qualified staff involved in product The firm has submitted photocopy of List of qualified staff along
development with relevant experience. with their training record involved in product development.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted copy of Product development Summary for
development & stability testing of trial Sacubitril + Valsartan tablets 97mg/103mg tablets. Summary
batches. includes following data:
 Pre-formulation studies.
 Raw material description.
 Formulation development.
 Manufacturing process
Firm has also submitted general SOP for Development of New

product.
SOP for Conducting stability studies (Document no.
QCD/SOP/CSS/005 issue no.01) has also been submitted with
effective date of 28-02-2018
10. Complete batch manufacturing record of The firm has submitted photocopy of Batch Manufacturing Record
three stability batches. and Batch Packaging Record of the following 03 Batches:

Lab-01 1700 Tablets 20-10-2017
Lab-02 1700 Tablets 20-10-2017
Lab-03 1700 Tablets 20-10-2017
11. Record of remaining quantities of stability The firm has submitted reconciliation sheet mentioning that 816
batches. tablets of each of three trial batches are remaining.
QA / QC DATA
12. Record of Digital data logger for  The firm has submitted photocopies of digital printouts of
temperature and humidity monitoring of graphical chart for Real Time and Accelerated Conditions
stability chambers (real time and starting from 10-01-2017 to 05-05-2018.
accelerated)
13. Method used for analysis of API along with The firm has applied supplier’s method for analysis of API and has
COA. submitted analytical reports, raw data sheets & relevant
chromatograms.
14. Method used for analysis of FPP &  The firm has submitted photocopy of Finished Product
complete record of testing of stability specification & Test method along with analytical method
batches (i.e. chromatograms, lab reports, validation report.
raw data sheets etc.)  Firm has submitted complete record of testing of stability
batches (i.e. chromatograms, lab reports, raw data sheets etc.)
15. Reports of stability studies of API from The firm has submitted copies of reports of 06 Months Accelerated
manufacturer. and 24 Months Real Time Stability Study (25oC+2 oC, 60+5%) Data
of 03 Batches of API from M/s Zhejiang Tianyu Pharmaceutical
Co., Ltd. China.
16. Analysis reports for excipients used. The firm has submitted copies of its own Analytical reports for all
excipients used in product development of Valsatril 97/103 mg film
coated tablets.
17. Drug-excipients compatibility studies.  The firm has submitted Compatibility study report (dated 24-
03-2018) along with raw data sheets and relevant
chromatograms.
18. Record of comparative dissolution data.  Firm has submitted CDP report dated 24-02-2018 for the
Valsatril mg 97/103 tablet. The details of reference product &

product M/s Sami
Brand name Entresto 97/103 Valsatril mg
mg tablets. 97/103 tablet
Batch No. T0001 Lab-01
Mfg. date 02-2016 Oct 2017
 Comparative dissolution studies have been performed in pH 6.8

Phosphate buffer as per USFDA recommended Dissolution
method

Dissolution results for both reference and sample product
are comparable.
19. Compliance Record of HPLC software Firm has submitted audit trail reports for complete stability studies
21CFR & audit trail reports on product analysis of three batches.
testing.
949. Name and address of manufacturer / M/s Sami Pharmaceuticals (Pvt.) Ltd. F-95, Off. Hub River
Applicant Road, S.I.T.E., Karachi
Brand Name +Dosage Form + Strength Valsatril 49mg/51mg Tablet
Diary No. Date of R& I & fee Dy#.:20898, 11-06-2018, Rs.50,000/- (11-06-2018)
Sacubitril …… 48.6 mg
Valsartan ….…. 51.4 mg
Pharmacological Group Angiotensin II antagonists
Type of Form Form-5
Pack size & Demanded Price As per latest decision taken by DPC in respect of usual/hardship cases.
Me-too status N/A
good level of GMP compliance.
Drug Valsatril 49mg/51mg Tablet
Name of Manufacturer M/s Sami Pharmaceuticals (Pvt.) Ltd. F-95, Off. Hub River Road, S.I.T.E., Karachi
Manufacturer of API M/s Zhejiang Tianyu Pharmaceutical Co., Ltd. China
API Lot No. L2016014 & L20161102
Description of Pack Alu – Alu blister
Frequency Real Time: 0,3 & 6 (months) Accelerated: 0,1,3,4 & 6 (months)
Batch No. Lab-001 Lab-002 Lab-003
Manufacturing Date 11-2017 20-10-2017 20-10-2017
No. of Batches 03
No.
1. COA of API Yes
2. Approval of API by regulatory authority of Copy of GMP certificate (certificate no. ZJ20130111) has been
country of origin or GMP certificate of API submitted for M/s Zhejiang Tianyu Pharmaceutical Co., Ltd. issued
manufacturer issued by regulatory by SFDA, China, and valid upto 12-09-2018.
authority of country of origin.
Yes
Yes
sheets etc.
5. Documents confirming import of API etc.  Copy of Form 6 (License to Import drug for clinical trial
No. L2016014/L20161102
Yes
Yes
Rules, 1978.

The firm has requested for Exemption from On-site Investigation of their submitted stability data and provided the
following documents in conjunction with the checklist approved by the Registration Board in its 278th Meeting:
instant dosage form conducted during last “TONOFLEX-P FORTE 75mg / 650mg (Tramadol HCl +
two years. Paracetamol) Tablets”, which was conducted on 08th January, 2018
and was presented in 278th meeting of Registration Board held on
29-31st January, 2017.
i. The HPLC software is 21CFR Compliant.
ii. Firm has shown all Audit trail reports.
iii. Adequate monitoring and control are available for stability
chambers. Data Loggers are also placed in stability chambers
for monitoring
2. Documents for the procurement of API with  Copy of Form 6 (License to Import drug for clinical trial
approval from DRAP (in case of import). examination, test or analysis) issued by ADC (Karachi) dated
No. L2016014/L20161102
3. Documents for the procurement of  Firm has submitted COAs of working/reference standards from
reference standard and impurity standards. M/s Zhejiang Tianyu Pharmaceutical Co., Ltd. China, detailed
as under:
Batch. # Quantity
WRS151201 10 mg
IRS160101 10 mg
IRS160901 10 mg
4. Approval of API/ DML/GMP certificate of Copy of GMP certificate (certificate no. ZJ20130111) has been
API manufacturer issued by regulatory submitted for M/s Zhejiang Tianyu Pharmaceutical Co., Ltd. issued
authority of country of origin. by SFDA, China, and valid upto 12-09-2018
5. Mechanism for Vendor pre-qualification The firm has submitted as under:

 We have selected API supplier on the basis of GMP compliance
and quantifying all tests of COA.
 Meets the criteria of impurity profiling.
 Documented vendor evaluation procedure followed.
 Availability of DMF.
6. Certificate of analysis of the API, reference  Copies of COAs of API have been submitted, detailed as under:
standards and impurity standards
API Batch. # Quantity
Sacubitril and L2016014 1Kg
valsartan as sodium
salt complex L20161102 1Kg
 Firm has submitted COAs of working/reference standards from

M/s Zhejiang Tianyu Pharmaceutical Co., Ltd. China, detailed
as under:
Batch. # Quantity
WRS151201 10 mg
IRS160101 10 mg
IRS160901 10 mg
7. Documents for the procurement of The firm has submitted commercial invoices & COAs of all the
excipients used in product development? excipients used in formulation of Valsatril 49/51 mg film coated
tablets, from relevant manufacturers.
8. List of qualified staff involved in product The firm has submitted photocopy of List of qualified staff along
development with relevant experience. with their training record involved in product development.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted copy of Product development Summary for
development & stability testing of trial Sacubitril + Valsartan tablets 49mg/51mg tablets. Summary includes
batches. following data:
 Pre-formulation studies.
 Raw material description.
 Formulation development.
 Manufacturing process
Firm has also submitted general SOP for Development of New

product.
SOP for Conducting stability studies (Document no.
QCD/SOP/CSS/005 issue no.01) has also been submitted with
effective date of 28-02-2018
10. Complete batch manufacturing record of The firm has submitted photocopy of Batch Manufacturing Record
three stability batches. and Batch Packaging Record of the following 03 Batches:

Lab-01 1700 Tablets 09-11-2017
Lab-02 1700 Tablets 09-11-2017
Lab-03 1700 Tablets 09-11-2017
QA / QC DATA
12. Record of Digital data logger for  The firm has submitted photocopies of digital printouts of
temperature and humidity monitoring of graphical chart for Real Time and Accelerated Conditions
stability chambers (real time and starting from 10-01-2017 to 05-05-2018.
accelerated)
13. Method used for analysis of API along with The firm has applied supplier’s method for analysis of API and has
COA. submitted analytical reports, raw data sheets & relevant
chromatograms.
complete record of testing of stability specification & Test method along with analytical method
batches (i.e. chromatograms, lab reports, validation report.
raw data sheets etc.)  Firm has submitted complete record of testing of stability
batches (i.e. chromatograms, lab reports, raw data sheets etc.)
15. Reports of stability studies of API from The firm has submitted copies of reports of 06 Months Accelerated
manufacturer. and 24 Months Real Time Stability Study (25oC+2 oC, 60+5%) Data
of 03 Batches of API from M/s Zhejiang Tianyu Pharmaceutical Co.,
Ltd. China.
excipients used in product development of Valsatril 49/51 mg film
coated tablets.
17. Drug-excipients compatibility studies.  The firm has submitted Compatibility study report (dated 24-03-
2018) along with raw data sheets and relevant chromatograms.
18. Record of comparative dissolution data.  Firm has submitted CDP report dated 24-02-2018 for the
Valsatril mg 49/51 tablet. The details of reference product &

product M/s Sami
Brand name Entresto 49/51 Valsatril mg
mg tablets. 49/51 tablet
Batch No. TH839 Lab-01
Mfg. date -- 11-2017
 Comparative dissolution studies have been performed in pH 6.8

Phosphate buffer as per USFDA recommended Dissolution
method

Dissolution results for both reference and sample product
are comparable.
19. Compliance Record of HPLC software Firm has submitted audit trail reports for complete stability studies
21CFR & audit trail reports on product analysis of three batches.
testing.
Decision: Registration Board decided to approve registration of “Valsatril 97mg/103mg Tablet (Sacubitril 97.2
mg/Valsartan 102.8 mg) & Valsatril 49mg/51mg Tablet (Sacubitril 48.6 mg/Valsartan 51.4 mg) by M/s Sami
Pharmaceuticals (Pvt.) Ltd. F-95, Off. Hub River Road, S.I.T.E., 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.
950. Name and address of manufacturer / M/s Aspin Pharma Plot # 10- 25, sector 20, Korangi industrial estate,
Applicant Karachi.
Brand Name +Dosage Form + Strength Jantovia X.R 50mg/500mg Tablet
Diary No. Date of R& I & fee Dyn:318, 9-05-2016, Rs.20,000/-
Sitagliptin phosphate monohydrate 64.25mg eq. to
Sitagliptin……50 mg
Metformin hydrochloride as extended release ….500 mg
Type of Form Form-5
Finished Product Specification AS per innovator
Pack size & Demanded Price 10’s Rs.1010/-
14’s Rs.1420/-
Approval status of product in Reference Janumet of Merch sharp (USFDA)
Me-too status Tagipmet XR tablet of Highnoon
Remarks of the Evaluator. Approved in USFDA with Box Warning: LACTIC ACIDOSIS.
th
Decision of 274 meeting: Registration Board decided to defer the application and advised the firm to
submit stability data as required in 251st Registration Board meeting.
Drug Jantovia X.R 50mg/500mg Tablet
Name of Manufacturer M/s Aspin Pharma Plot # 10- 25, sector 20, Korangi industrial estate, Karachi
Manufacturer of API Metfromin HCl:
M/s Aarti Drugs Ltd. (Unit-II), India
Sitagliptin phosphate monohydrate:
M/s Zhejiang Tianyu Pharmaceutical Co., Ltd. China
API Lot No. Metfromin HCl:
MEF/16101052
Sitagliptin phosphate monohydrate: 12300-161007
Description of Pack HDPE bottle
Batch No. 033/2017 034/2017 035/2017
Batch Size 1.6 Kg 1.6 Kg 1.6 Kg
No. of Batches 03
Sr. No. Documents To Be Provided Status
1. COA of API Yes
2. Approval of API by regulatory Metformin HCL:
authority of country of origin or GMP Copy of GMP certificate (certificate No. 1706181) has been
certificate of API manufacturer issued submitted for M/s Aarti Drugs Ltd. (Unit-II) issued by Food & Drug
by regulatory authority of country of Control Administration, Gujarat, India valid upto 14-12-2017.
origin. Valid GMP certificate shall be submitted.
Copy of GMP certificate (certificate no. ZJ20160065) has been
submitted for M/s Zhejiang Tianyu Pharmaceutical Co., Ltd. issued
by SFDA, China, and valid upto 12-05-2021.
Yes
4. Data of 03 batches will be supported
by attested respective documents like
Yes
chromatograms, laboratory reports,
data sheets etc.
5. Documents confirming import of API Metformin HCL:
etc.  Copy of Form 6 (License to Import drug for clinical trial
14-02-2017, for the import of Metformin HCl (25 Kg) from the
M/s Aarti Drugs Ltd. has been submitted.
 Copy of Commercial Invoice (invoice no. EXP/2015/16-17)
attested by ADC (Karachi) dated 22-01-2017 has been
submitted.
 Copy of Form 6 (License to Import drug for clinical trial
27-10-2016, for the import of Sitagliptin phosphate
monohydrate (03 Kg).
 Copy of Commercial Invoice (invoice no. HK1610212-C)
submitted.
 Name of vendor has been mentioned on both Form 6 and
Commercial invoice instead of manufacturer. Link between
vendor and Manufacturer shall be established.
6. All provided documents will be
attested (name, sign and stamp) for
Yes
ensuring authenticity of data /
documents.
7. Commitment to continue real time
stability study till assigned shelf life of Yes
the product.
8. Commitment to follow Drug
Yes
Specification Rules, 1978.

QO-020/2018, dated 30-04-2018 and provided the following documents in conjunction with the checklist approved by
the Registration Board in its 278th Meeting:
1. Reference of last onsite panel Firm has referred to onsite inspection report of their product
inspection for instant dosage form “DASAVIR 60mg (Daclatasvir) Tablets”, which was conducted on
conducted during last two years. 11th January, 2018 and was presented in 278th meeting of
Registration Board held on 29-31st January, 2017.

i. Firm has used two HPLC systems for stability studies of Dasavir
60mg tablets. The HPLC used upto 06 months studies has
software not 21CFR compliant whereas, the second HPLC used
for 09 months studies and scheduled to be used for further
studies has software 21CFR compliant.
ii. Audit trail on the testing reports can be made from 09 months
studies.
2. Documents for the procurement of API Metformin HCL:
with approval from DRAP (in case of  Copy of Form 6 (License to Import drug for clinical trial
import). examination, test or analysis) issued by ADC (Karachi) dated
submitted.
submitted.
3. Documents for the procurement of  The firm has submitted copy of invoice and delivery challan
reference standard and impurity dated 03-08-2017 from M/s Lab Solutions in the name of M/s
standards. Aspin Pharma (Pvt.) Ltd, Karachi, declaring the submission of
following reference standards.
Particulars Cat. # USP Quantity

Lot#.
Metformin HCL 1396309 (USP) R069H0 200mg
Sitagliptin phosphate 1612903 (USP) F030N0 200mg
 Copy USP certificates for both reference standards have also

been submitted.
4. Approval of API/ DML/GMP Metformin HCL:
certificate of API manufacturer issued Copy of GMP certificate (certificate No. 1706181) has been
by regulatory authority of country of submitted for M/s Aarti Drugs Ltd. (Unit-II) issued by Food & Drug
origin. Control Administration, Gujarat, India valid upto 14-12-2017.
Valid GMP certificate shall be submitted.
5. Mechanism for Vendor pre-  The firm has submitted copy of “cGMP Questionnaire for the
qualification evaluation of Raw materials manufacturer”, filled for M/s Aarti
Drugs Ltd., India dated 27-04-2018.
 No relevant document has been submitted for vendor pre-
qualification of supplier of Sitagliptin i.e. M/s Zhejiang Tianyu
Pharmaceutical Co., Ltd, China.
6. Certificate of analysis of the API,  Copies of COAs of both APIs have been submitted, detailed as
reference standards and impurity under:
standards
API Manufacturer Batch No.
Metformin M/s Aarti Drugs Ltd., MEF/1601052
HCL India
Sitagliptin M/s Zhejiang Tianyu 12300-161007
phosphate Pharmaceutical Co.,
monohydrate Ltd. China
7. Documents for the procurement of The firm has only submitted COAs of all the excipients used in
excipients used in product formulation of Jantovia XR tablets, from relevant manufacturers.
development?  Evidence of procurement i.e. Purchase Order/Invoices etc. shall
be submitted for excipients used in product development.
8. List of qualified staff involved in The firm has submitted photocopy of List of qualified staff involved
product development with relevant in product development comprising of 07 members.
experience.
Production Data
9. Authorized Protocols/SOP for the  The firm has submitted copy of Development Protocol for
development & stability testing of trial Jantovia XR film coated tablets 50/500 details of which are as
batches. under:
 Title of Document: Stability Batch manufacturing Instruction.
 Document No.: SBMR.JANTOVIA XR.500-50/01.
 Document effective date: 07-02-2017.
Copies of Pharmaceutical development report for Jantovia XR

film coated tablets range details of which are as under:
 Document No.: PD/SOP/NPD/001-E
 Report No.: PDR-001/18
 Authorization date: 27-04-2018
 Firm has applied Active coating technology for depositing
Sitagliptin layer upon Metformin extended release core.
 Protocol development report mentions a note as under:
“Extra coating material will be issued to compensate the coating
loses during Sitagliptin coating process.”
10. Complete batch manufacturing record The firm has submitted photocopy of Batch Manufacturing Record
of three stability batches. and Batch Packaging Record of the following 03 Batches:

033/2017 1600 Tablets 13-04-2017
034/2017 1600 Tablets 13-04-2017
035/2017 1600 Tablets 13-04-2017
 As per submitted record 14% extra coating solution was

prepared to compensate the coating losses during API coating
process of Sitagliptin.
 Justification of 14% extra coating solution of Sitagliptin in
master formulation (which is required to be based on
study/scientific rationale) for which firm has stated that it was
033/2017:
 In-process testing for “Weight variation after film coating” has
been performed on 26-05-2017, whereas date mentioned on
“Stability batch manufacturing record” for the process of film
coating is 29-05-2017. Clarification shall be submitted in this
regard.
11. Record of remaining quantities of The firm has submitted reconciliation sheet mentioning that 224
stability batches. tablets of each of three trial batches are remaining.
QA / QC DATA
12. Record of Digital data logger for  The firm has submitted photocopies of printouts of digital data
temperature and humidity monitoring loggers for Real Time and Accelerated Conditions starting 02-
of stability chambers (real time and 2017 to 10-2017.
accelerated).
13. Method used for analysis of API along Metformin HCL:
with COA.  The firm has submitted photocopy of Raw material control
method & Specifications (Spec. # 33247 effective date 09-02-
2017).
 Copy of firm’s own raw material analytical report for Metformin
HCL (Manufacturer’s batch no. MEF/16101052) DATED 21-
02-2017 has been submitted.
 Firm has mentioned in Raw material control method &
Specifications that “Acetic anhydride is banned in Pakistan
which is required to perform assay test according to USP s we
used Assay method of BP instead of USP.”
 The firm has submitted photocopy of Raw material control
method & Specifications (Spec. # 33246 effective date 09-11-
2016).
 Copy of firm’s own raw material analytical report for Sitagliptin
phosphate (Manufacturer’s batch no. 12300-161007) dated 09-
11-2016 has been submitted.
 FTIR spectrum & HPLC chromatograms have also been
submitted for raw material analysis.
 As per submitted chromatograms assay of Sitagliptin Phosphate
has been performed on 08-11-2016, whereas effective date of
Raw material control method & Specifications for Sitagliptin is
09-11-2016. Clarification shall be submitted in this regard.
14. Method used for analysis of FPP  The firm has submitted photocopy of Finished Product
&complete record of testing of stability specification (LS.PSP-009 version no. 01 effective date 27-03-
batches (i.e. chromatograms, lab 2017) & Standard Test method (LS.TMT-009 version no. 01
reports, raw data sheets etc.) effective date 27-03-2017) for Jantovia-XR 50/500mg tablets.
 In contrary to Dissolution method recommended by USFDA
firm has mentioned separate dissolution test for Sitagliptin &
Metformin HCl in applied formulation whereas USFDA
recommends that dissolution of both Sitagliptin & Metformin
HCL shall be performed simultaneously in a single test.
 Dissolution parameter of paddle speed i.e. 100rpm, mentioned
in Dissolution test of Metformin HCL is different from that
recommended by USFDA i.e. 75 rpm.
 Record of testing of stability batches (i.e. chromatograms, lab
reports, raw data sheets has also been submitted
033/2017:
 As per submitted testing record initial testing at film coated stage
for the batch no. 033/2017, was performed on 26-05-2017,
whereas submitted “Stability batch manufacturing record” of
batch no. 033/2017 shows that film coating has been performed
on 29-05-2017. Clarification shall be submitted in this regard.
034/2017:
 Analytical report of batch no. 034/2017 has been signed on 27-
05-2017, whereas submitted chromatograms show that analysis
has been started on 09-06-2017. Clarification shall be submitted
in this regard.
for the batch# 034/2017, was started on 09-06-2017, whereas
submitted “Stability batch manufacturing record” of batch no.
034/2017 shows that film coating has been performed on 16-06-
2017. Clarification shall be submitted in this regard.
035/2017:
for the batch# 035/2017, was started on 12-06-2017, whereas
submitted “Stability batch manufacturing record” of batch no.
035/2017 shows that film coating has been performed on 16-06-
2017. Clarification shall be submitted in this regard.
15. Reports of stability studies of API from Metformin HCL:
manufacturer.  The firm has submitted copies of reports of 03 Months
Accelerated and 03 Months Real Time Stability Study (25oC+2
o
C, 60+5%) Data of 03 Batches of Metformin HCl from M/s
Zhejiang Tianyu Pharmaceutical Co., Ltd. China.
 Complete 6 months accelerated and long term stability data till
assigned shelf life shall be submitted.
Sitagliptin Phosphate monohydrate:
 The firm has submitted copies of reports of 06 Months
Accelerated and 60 Months Real Time Stability Study (25oC+2
o
C, 60+5%) Data of 03 Batches of Sitagliptin Phosphate
monohydrate from M/s Aarti drugs Ltd. India.
excipients used in product development of Jantovia XR tablets.
studies stating as under:
“The firm has not performed Drug-excipient compatibility studies as
their formulation is similar to that of the innovator formulation.”
 In contrary to reference product JanuMet XR tablets firm has
applied a seal coating upon Metformin extended release core,
clarification/justification shall be submitted in this regard.
18. Record of comparative dissolution  Firm has submitted CDP report (CDP-R004) dated 24-01-2018
data. for the Jantovia XR 100/1000mg tablets. The details of reference
product & Sample product are as follows:

product M/s Aspin
Brand name Janumet XR Jantovia XR
100/1000 mg 100/1000mg
tablet tablets
Batch No. M032116 032/2017
following mediums:
i. pH 1.2 HCl buffer
ii. pH 4.5 Acetate buffer
iii. pH 6.8 Phosphate buffer
MEDIUM F2 factor for F2 factor for
Sitagliptin Metformin HCl
pH 1.2 HCl buffer 56.27 69.7
pH 4.5 Acetate buffer 60.23 71.5
pH 6.8 Phosphate buffer 60.99 66.83
 Dissolution parameter of paddle speed i.e. 100rpm mentioned in
Dissolution test of CDP is different from that recommended by
USFDA i.e. 75 rpm.
19. Compliance Record of HPLC software  Initial testing was performed on old HPLC systems, those
21CFR & audit trail reports on product were not 21CFR compliant. However, a new 21 CFR
testing. compliant HPLC has been procured with certificate of
compliance. The audit trail for onward testing is attached.
Name & Address Brand Name Type of Form, International Availability / Local
of Manufacturer / (Proprietary Name Initial Diary & Availability
Applicant + Dosage Form + Date, Fee
Strength), (including GMP Inspection Report Date &
Composition, differential fee), Remarks
Pharmacological Demanded Price /
Group, Pack size
Finished Product
Specification
951. M/s Aspin Pharma Jantovia X.R Form-5 Janumet of Merch sharp (USFDA)
Plot # 10- 25, 50mg/1000mg Tablet Dy No:314, 9-05-
sector 20, Korangi Each film coated 2016, Rs.20,000/- Last GMP Inspection dated 20-02-2018
industrial estate, tablet contains: 10‘sRs.1020/- with conclusive remarks of satisfactory
Karachi. Sitagliptin phosphate 14‘s Rs.1430/- level of GMP compliance.
monohydrate
64.25mg eq. to
Sitagliptin……50 mg
Metformin
hydrochloride as
extended release
….1000 mg
Anti-diabetic
Decision of 274th meeting: Registration Board decided to defer the application and advised the firm to
submit stability data as required in 251st Registration Board meeting.
Remarks of Evaluator:
The firm has submitted stability study data along with required documents as per checklist approved in 276th
meeting of Registration Board for exemption from “On site investigation of submitted stability data”.
Detailsof submitted data are as under:
(Dy.# 16837 dated 7-05-2018)
Drug Jantovia X.R 50mg/1000mg Tablet
Manufacturer of API Metfromin HCl: M/s Aarti Drugs Ltd. (Unit-II), India
API Lot No. Metfromin HCl: MEF/16101052
Batch No. 026/2017 028/2017 029/2017
No. of Batches 03
1. COA of API Yes
2. Approval of API by regulatory Metformin HCL:

authority of country of origin or GMP Copy of GMP certificate (certificate No. 1706181) has been
certificate of API manufacturer issued submitted for M/s Aarti Drugs Ltd. (Unit-II) issued by Food & Drug
by regulatory authority of country of Control Administration, Gujarat, India valid upto 14-12-2017.
origin. Valid GMP certificate shall be submitted.
Yes
4. Data of 03 batches will be supported
by attested respective documents like
Yes
chromatograms, laboratory reports,
data sheets etc.
5. Documents confirming import of API Metformin HCL:
etc.  Copy of Form 6 (License to Import drug for clinical trial
submitted.
submitted.
6. All provided documents will be
attested (name, sign and stamp) for
Yes
ensuring authenticity of data /
documents.
7. Commitment to continue real time
stability study till assigned shelf life of Yes
the product.
8. Commitment to follow Drug
Yes
Specification Rules, 1978.
inspection for instant dosage form “DASAVIR 60mg (Daclatasvir) Tablets”, which was conducted on
conducted during last two years. 11th January, 2018 and was presented in 278th meeting of
Registration Board held on 29-31st January, 2017.
iii. Firm has used two HPLC systems for stability studies of Dasavir
60mg tablets. The HPLC used upto 06 months studies has
software not 21CFR compliant whereas, the second HPLC used
for 09 months studies and scheduled to be used for further
studies has software 21CFR compliant.
iv. Audit trail on the testing reports can be made from 09 months
studies.
2. Documents for the procurement of API Metformin HCL:
with approval from DRAP (in case of  Copy of Form 6 (License to Import drug for clinical trial
import). examination, test or analysis) issued by ADC (Karachi) dated
submitted.
submitted.
3. Documents for the procurement of  The firm has submitted copy of invoice and delivery challan
reference standard and impurity dated 03-08-2017 from M/s Lab Solutions in the name of M/s
standards. Aspin Pharma (Pvt.) Ltd, Karachi, declaring the submission of
following reference standards.

Lot#.
Metformin HCL 1396309 (USP) R069H0 200mg
Sitagliptin phosphate 1612903 (USP) F030N0 200mg
 Copy USP certificates for both reference standards have also

been submitted.
4. Approval of API/ DML/GMP Metformin HCL:
certificate of API manufacturer issued Copy of GMP certificate (certificate No. 1706181) has been
by regulatory authority of country of submitted for M/s Aarti Drugs Ltd. (Unit-II) issued by Food & Drug
origin. Control Administration, Gujarat, India valid upto 14-12-2017.
5. Mechanism for Vendor pre-  The firm has submitted copy of “cGMP Questionnaire for the
qualification evaluation of Raw materials manufacturer”, filled for M/s Aarti
Drugs Ltd., India dated 27-04-2018.
qualification of supplier of Sitagliptin i.e. M/s Zhejiang Tianyu
Pharmaceutical Co., Ltd, China.
6. Certificate of analysis of the API,  Copies of COAs of both APIs have been submitted, detailed as
reference standards and impurity under:
standards
Metformin M/s Aarti MEF/1601052
HCL Drugs Ltd.,
India
Sitagliptin M/s Zhejiang 12300-161007
phosphate Tianyu
monohydrate Pharmaceutical
Co., Ltd. China
 No relevant document has been submitted for any impurity.
 Submitted COA of Sitagliptin Phosphate monohydrate mentions
report date as 07-01-2017, whereas ADC tested invoice is of date
27-10-2017.
7. Documents for the procurement of The firm has only submitted COAs of all the excipients used in
excipients used in product formulation of Jantovia XR tablets, from relevant manufacturers.
development?  Evidence of procurement i.e. Purchase Order/Invoices etc. shall
be submitted for excipients used in product development.
8. List of qualified staff involved in The firm has submitted photocopy of List of qualified staff involved
product development with relevant in product development comprising of 07 members.
experience.
Production Data
9. Authorized Protocols/SOP for the  The firm has submitted copy of Development Protocol for
development & stability testing of trialJantovia XR film coated tablets 50/1000mg
batches. 
Firm has applied Active coating technology for depositing
10. Complete batch manufacturing record The firm has submitted photocopy of Batch Manufacturing Record
of three stability batches. and Batch Packaging Record of the following 03 Batches:

026/2017 1600 Tablets 28-02-2017
028/2017 1600 Tablets 21-03-2017
029/2017 1600 Tablets 13-04-2017
study/scientific rationale) for which firm has stated that it was
11. Record of remaining quantities of The firm has submitted reconciliation sheet mentioning that 224
stability batches. tablets of each of three trial batches are remaining.
QA / QC DATA
12. Record of Digital data logger for  The firm has submitted photocopies of printouts of digital data
temperature and humidity monitoring loggers for Real Time and Accelerated Conditions starting 02-
of stability chambers (real time and 2017 to 10-2017.
accelerated)
13. Method used for analysis of API along Firm has submitted complete method of analysis along with COA of
with COA. both API
complete record of testing of stability specification (LS.PSP-009 version no. 01 effective date 27-03-
batches (i.e. chromatograms, lab 2017) & Standard Test method (LS.TMT-009 version no. 01
reports, raw data sheets etc.) effective date 27-03-2017) for Jantovia-XR 50/1000mg tablets.
 In contrary to Dissolution method recommended by USFDA
firm has mentioned separate dissolution test for Sitagliptin &
Metformin HCl in applied formulation whereas USFDA
recommends that dissolution of both Sitagliptin & Metformin
HCL shall be performed simultaneously in a single test.
 Dissolution parameter of paddle speed i.e. 100rpm, mentioned
in Dissolution test of Metformin HCL is different from that
 Record of testing of stability batches (i.e. chromatograms, lab
reports, raw data sheets has also been submitted
15. Reports of stability studies of API from Firm has submitted stability study data of both API
manufacturer.
excipients used in product development of Jantovia XR tablets.
“The firm has not performed Drug-excipient compatibility studies as
their formulation is similar to that of the innovator formulation.”
 In contrary to reference product JanuMet XR tablets firm has
applied a seal coating upon Metformin extended release core,
clarification/justification shall be submitted in this regard.
18. Record of comparative dissolution  Firm has submitted CDP report of 100/1000mg strength only
data.
19. Compliance Record of HPLC software  Initial testing was performed on old HPLC systems, those
21CFR & audit trail reports on product were not 21CFR compliant. However, a new 21 CFR
testing. compliant HPLC has been procured with certificate of
952. Name and address of manufacturer / M/s Aspin Pharma Plot # 10- 25, sector 20, Korangi industrial
Applicant estate, Karachi.
Brand Name +Dosage Form + Strength Jantovia-XR 100mg/1gm Tablet
Diary No. Date of R& I & fee Dyn:313, 9-05-2016, Rs.20,000/-
Composition Each extended release film coated tablet contains:
Sitagliptin phosphate monohydrate 128.5mg eq. to
sitqagliptin……100 mg
Metformin hydrochloride as extended release….1 gm
Type of Form Form-5
Finished Product Specification AS per innovator
Pack size & Demanded Price 10’s, 14’s (2020/10’s, 2830/14’s)
Approval status of product in Janumet of Merch sharp (USFDA)
Me-too status Tagipmet XR tablet of Highnoon
remarks of satisfactory level of GMP compliance.
Remarks of the Evaluator. Approved in USFDA with Box Warning: LACTIC
ACIDOSIS.
Decision of 274th meeting: Registration Board decided to defer the application and advised the
firm to submit stability data as required in 251st Registration Board meeting.
Drug Jantovia-XR 100mg/1gm Tablet
Manufacturer of API Metfromin HCl:
M/s Aarti Drugs Ltd. (Unit-II), India
API Lot No. Metfromin HCl: MEF/16101052
Batch No. 030/2017 031/2017 032/2017
No. of Batches 03
No.
1. COA of API Yes
2. Approval of API by regulatory authority of Metformin HCL:
country of origin or GMP certificate of API Copy of GMP certificate (certificate No. 1706181) has been
manufacturer issued by regulatory authority of submitted for M/s Aarti Drugs Ltd. (Unit-II) issued by Food &
country of origin. Drug Control Administration, Gujarat, India valid upto 14-12-
2017.
submitted for M/s Zhejiang Tianyu Pharmaceutical Co., Ltd.
issued by SFDA, China, and valid upto 12-05-2021.
Yes
Yes
chromatograms, laboratory reports, data sheets
etc.
5. Documents confirming import of API etc. Metformin HCL:
dated 14-02-2017, for the import of Metformin HCl (25
Kg) from the M/s Aarti Drugs Ltd. has been submitted.
 Copy of Commercial Invoice (invoice no. EXP/2015/16-
17) attested by ADC (Karachi) dated 22-01-2017 has been
submitted.
dated 27-10-2016, for the import of Sitagliptin phosphate
submitted.
Commercial invoice instead of manufacturer. Link
between vendor and Manufacturer shall be established.
sign and stamp) for ensuring authenticity of Yes
data / documents.
Yes
Yes
Rules, 1978.
QO-020/2018, dated 30-04-2018 and provided the following documents in conjunction with the checklist approved by
the Registration Board in its 278th Meeting:
instant dosage form conducted during last two “DASAVIR 60mg (Daclatasvir) Tablets”, which was
years. conducted on 11th January, 2018 and was presented in 278th
meeting of Registration Board held on 29-31st January, 2017.
v. Firm has used two HPLC systems for stability studies of
Dasavir 60mg tablets. The HPLC used upto 06 months
studies has software not 21CFR compliant whereas, the
second HPLC used for 09 months studies and scheduled to
be used for further studies has software 21CFR compliant.
vi. Audit trail on the testing reports can be made from 09
months studies.
2. Documents for the procurement of API with Metformin HCL:
approval from DRAP (in case of import).  Copy of Form 6 (License to Import drug for clinical trial
dated 14-02-2017, for the import of Metformin HCl (25 Kg)
from the M/s Aarti Drugs Ltd. has been submitted.
 Copy of Commercial Invoice (invoice no. EXP/2015/16-
17) attested by ADC (Karachi) dated 22-01-2017 has been
submitted.
dated 27-10-2016, for the import of Sitagliptin phosphate
submitted.
3. Documents for the procurement of reference  The firm has submitted copy of invoice and delivery challan
standard and impurity standards. dated 03-08-2017 from M/s Lab Solutions in the name of
M/s Aspin Pharma (Pvt.) Ltd, Karachi, declaring the
submission of following reference standards.

Lot#.
Metformin HCL 1396309 R069H0 200mg
(USP)
Sitagliptin 1612903 F030N0 200mg
phosphate (USP)
 Copy USP certificates for both reference standards have

also been submitted.
4. Approval of API/ DML/GMP certificate of API Metformin HCL:
manufacturer issued by regulatory authority of Copy of GMP certificate (certificate No. 1706181) has been
country of origin. submitted for M/s Aarti Drugs Ltd. (Unit-II) issued by Food &
Drug Control Administration, Gujarat, India valid upto 14-12-
2017.
submitted for M/s Zhejiang Tianyu Pharmaceutical Co., Ltd.
issued by SFDA, China, and valid upto 12-05-2021.
5. Mechanism for Vendor pre-qualification  The firm has submitted copy of “cGMP Questionnaire for
the evaluation of Raw materials manufacturer”, filled for
M/s Aarti Drugs Ltd., India dated 27-04-2018.
qualification of supplier of Sitagliptin i.e. M/s Zhejiang
Tianyu Pharmaceutical Co., Ltd, China.
6. Certificate of analysis of the API, reference  Copies of COAs of both APIs have been submitted, detailed
standards and impurity standards as under:

Metformin M/s Aarti MEF/1601052
HCL Drugs Ltd.,
India
Sitagliptin M/s Zhejiang 12300-161007
phosphate Tianyu
monohydrate Pharmaceutical
Co., Ltd. China
 No relevant document has been submitted for any impurity.
 Submitted COA of Sitagliptin Phosphate monohydrate
mentions report date as 07-01-2017, whereas ADC attested
invoice is of date 27-10-2017.
7. Documents for the procurement of excipients The firm has only submitted COAs of all the excipients used in
used in product development? formulation of Jantovia XR tablets, from relevant
manufacturers.
 Evidence of procurement i.e. Purchase Order/Invoices etc.
shall be submitted for excipients used in product
development.
development with relevant experience. involved in product development comprising of 07 members.
Production Data
9. Authorized Protocols/SOP for the development  The firm has submitted copy of Development Protocol for
& stability testing of trial batches. Jantovia XR film coated tablets 100/1000mg details of
which are as under:
 Title of Document: Stability Batch manufacturing
Instruction.
 Document No.: SBMR.JANTOVIA XR.1000-100/01.
 Document effective date: 07-02-2017.
 Copies of Pharmaceutical development report for Jantovia

XR film coated tablets range details of which are as under:
 Document No.: PD/SOP/NPD/001-E
 Report No.: PDR-001/18
 Authorization date: 27-04-2018

Firm has applied Active coating technology for depositing
Batches:

030/2017 1600 Tablets 06-04-2017
031/2017 1600 Tablets 11-04-2017
032/2017 1600 Tablets 13-04-2017
prepared to compensate the coating losses during API
coating process of Sitagliptin.
study/scientific rationale) for which firm has stated that it
was prepared to compensate the coating losses during API
coating process of Sitagliptin.
QA / QC DATA
12. Record of Digital data logger for temperature  The firm has submitted photocopies of printouts of digital
and humidity monitoring of stability chambers data loggers for Real Time and Accelerated Conditions
(real time and accelerated) starting 01-02-2017 to 29-10-2017.
13. Method used for analysis of API along with Metformin HCL:
COA.  The firm has submitted photocopy of Raw material control
method & Specifications (Spec. # 33247 effective date 09-
02-2017).
 Copy of firm’s own raw material analytical report for
Metformin HCL (Manufacturer’s batch no.
MEF/16101052) DATED 21-02-2017 has been submitted.
 Firm has mentioned in Raw material control method &
Specifications that “Acetic anhydride is banned in Pakistan
which is required to perform assay test according to USP
we used Assay method of BP instead of USP.”
 The firm has submitted photocopy of Raw material control
method & Specifications (Spec. # 33246 effective date 09-
11-2016).
 Copy of firm’s own raw material analytical report for
Sitagliptin phosphate (Manufacturer’s batch no. 12300-
161007) dated 09-11-2016 has been submitted.
 FTIR spectrum & HPLC chromatograms have also been
submitted for raw material analysis.
 As per submitted chromatograms assay of Sitagliptin
Phosphate has been performed on 08-11-2016, whereas
effective date of Raw material control method &
Specifications for Sitagliptin is 09-11-2016. Clarification
shall be submitted in this regard.
14. Method used for analysis of FPP & complete  The firm has submitted photocopy of Finished Product
record of testing of stability batches (i.e. specification (LS.PSP-008 version no. 01 effective date 27-
chromatograms, lab reports, raw data sheets 03-2017) & Standard Test method (LS.TMT-008 version
etc.) no. 01 effective date 27-03-2017) for Jantovia-XR
100/1000mg tablets.
 In contrary to Dissolution method recommended by
USFDA firm has mentioned separate dissolution test for
Sitagliptin & Metformin HCl in applied formulation
whereas USFDA recommends that dissolution of both
Sitagliptin & Metformin HCL shall be performed
simultaneously in a single test. Clarification shall be
submitted in this regard.
 Dissolution parameter of paddle speed i.e. 100rpm,
mentioned in Dissolution test of Metformin HCL is
different from that recommended by USFDA i.e. 75 rpm.
 Record of testing of stability batches (i.e. chromatograms,
lab reports, raw data sheets has also been submitted
15. Reports of stability studies of API from Sitagliptin Phosphate monohydrate:
manufacturer.  The firm has submitted copies of reports of 03 Months
Accelerated and 03 Months Real Time Stability Study
(25oC±2 oC, 60±5%) Data of 03 Batches of Sitagliptin
Phosphate monohydrate from M/s Zhejiang Tianyu
Pharmaceutical Co., Ltd. China.
 Complete 6 months accelerated and long term stability data
till assigned shelf life shall be submitted.
Metformin HCL:
 The firm has submitted copies of reports of 06 Months
Accelerated and 60 Months Real Time Stability Study
(25oC±2oC, 60±5%) Data of 03 Batches of Metformin HCL
from M/s Aarti drugs Ltd. India.
16. Analysis reports for excipients used. The firm has submitted copies of its own Analytical reports for
all excipients used in product development of Jantovia XR
tablets.
“The firm has not performed Drug-excipient compatibility
studies as their formulation is similar to that of the innovator
formulation.”
 In contrary to reference product JanuMet XR tablets firm
has applied a seal coating upon Metformin extended release
core, clarification/justification shall be submitted in this
regard.
18. Record of comparative dissolution data.  Firm has submitted CDP report (CDP-R004) dated 24-01-
2018 for the Jantovia XR 100/1000mg tablets. The details
of reference product & Sample product are as follows:
Feature Reference product Product of M/s

Aspin
Brand name Janumet XR Jantovia XR
100/1000mg tablet 100/1000mg tablets
Batch No. M032116 032/2017
following mediums:
i. pH 1.2 HCl buffer
ii. pH 4.5 Acetate buffer
iii. pH 6.8 Phosphate buffer
MEDIUM F2 factor F2 factor for

for Metformin
Sitagliptin HCl
pH 1.2 HCl buffer 56.27 69.7
pH 4.5 Acetate buffer 60.23 71.5
pH 6.8 Phosphate buffer 60.99 66.83
 Dissolution parameter of paddle speed i.e. 100rpm
mentioned in Dissolution test of CDP is different from that
19. Compliance Record of HPLC software 21CFR  Initial testing was performed on old HPLC systems, those
& audit trail reports on product testing. were not 21CFR compliant. However, a new 21 CFR
compliant HPLC has been procured with certificate of
Upon communication of observations vide letter no. F.1-1/2017/PEC-DRAP (AD PEC-II) dated 28-05-2018, firm has
replied vide its letter no QO-027/2018 dated 06-06-2018 which is detailed as under:

i. Details of equipment used along with We have used a conventional coating pan for the coating of Sitagliptin
justification for its suitability for applying layer over Metformin HCl extended release core. In this set up coating
layer of Sitagliptin over Metformin HCl solution was sprayed through a pneumatic spray gun having an aperture
extended release core, shall be submitted size of 0.5 mm which was connected with a peristaltic pump. Snap shots
of the equipment are attached herewith.
ii. Valid GMP certificate for M/s Aarti Drugs Copy of GMP certificate (certificate No. 1801541) has been submitted for
Ltd. (Unit-II), India (supplier of Metformin M/s Aarti Drugs Ltd. (Unit-II) issued by Food & Drug Control
HCl) shall be submitted Administration, Gujarat, India valid upto 09-01-2020.
iii. Evidence of procurement i.e. Purchase Firm has submitted copies of invoices along with analytical reports for all
Order/Invoices etc. shall be submitted for the excipients used in the formulation of Jantovia XR tablets
excipients used in product development.
iv. Justification of 14% extra coating solution These stability batches are manufactured on small scale where the coating
of Sitagliptin in master formulation (which losses were significant in terms of %age, due to vaporization & adherence
is required to be based on study/scientific of Sitagliptin coating solution on the surfaces of coating pan. During trial
rationale) for which firm has stated that it batches about 14% losses were observed. However, during process
was prepared to compensate the coating validation of commercial manufacturing this aspect will be revalidated.
losses during API coating process of Moreover, the weight gain of the tablets after coating is the indicator of
Sitagliptin. coating Sitagliptin in desired amount.
v. In-process testing for “Weight variation We have investigated this at our end and found that in actual the film-
after film coating” has been performed on coating was performed on 29-5-2017 (copy of log book is attached).
26-05-2017, whereas date mentioned on However, weight variation would have been checked immediately after
coating but erroneously dated on 26.05.2017
“Stability batch manufacturing record” for
the process of film coating is 29-05-2017.
Clarification shall be submitted in this
regard.
vi. As per submitted chromatograms assay of The testing of Sitagliptin was performed on 08.11.2016 by using the USP
Sitagliptin Phosphate has been performed monograph and while in-house control method (Doc. No. 33246) was
on 08-11-2016, whereas effective date of developed 07.11.2016 with effective date of 9-11-2016.
Raw material control method &
Specifications for Sitagliptin is 09-11-
2016. Clarification shall be submitted in
this regard.
vii. In contrary to Dissolution method In case of Sitagliptin, we adopted USFDA recommended method for the
recommended by USFDA firm has dissolution test whereas in case of Metformin HCl we used dissolution
mentioned separate dissolution test for Test No.4 as defined under the USP monograph “Metformin
Sitagliptin & Metformin HCl in applied
Hydrochloride Extended Release Tablet”.
formulation whereas USFDA recommends
that dissolution of both Sitagliptin & Reason for this being that USFDA method is only applicable to the
Metformin HCl shall be performed Sitagliptin + Metformin HCl tablet (immediate release) and not to the
simultaneously in a single test. extended release tablet. (Copy of both methods area attached)
regard.
viii. Dissolution parameter of paddle speed i.e. As mentioned in point No. VII, we followed the USP method of
100rpm, mentioned in Dissolution test of dissolution for Metformin HCl extended release tablets which
Metformin HCL is different from that recommends the paddle speed of 100 rpm.
ix. As per submitted testing record initial In case of Batch No. 033/2017, Film coating was performed on 29.05.2017
testing at film coated stage for the batch no. after obtaining the satisfactory results for Assay content of Sitagliptin that
033/2017, was performed on 26-05-2017, was tested on 26.05.2017.
This practice is adopted to ensure that correct amount of Sitagliptin has
whereas submitted “Stability batch
coated before moving to film-coating process as no corrections can be
manufacturing record” of batch no. made after film-coating.
033/2017 shows that film coating has been
performed on 29-05-2017. Clarification
x. Analytical report of batch no. 034/2017 has This is a typo error by the analyst, and actual testing was completed on
been signed on 27-05-2017, whereas 13.06.2017. Copy of log book is attached.
submitted chromatograms show that
analysis has been started on 09-06-2017.
regard.
xi. As per submitted testing record initial In case of Batch No. 034/2017, Film coating was performed on 13.06.2017
testing at film coated stage for the batch# after obtaining the satisfactory results for Assay content of Sitagliptin that
034/2017, was started on 09-06-2017, was tested on 09.06.2017.
manufacturing record” of batch no. made after film-coating
xii. As per submitted testing record initial In case of Batch No. 035/2017, Film coating was performed on 16.06.2017
testing at film coated stage for the batch# after obtaining the satisfactory results for Assay content of Sitagliptin that
035/2017, was started on 12-06-2017, was tested on 12.06.2017.
manufacturing record” of batch no. made after film-coating.
xiii. Complete 6 months accelerated and long Complete 6 months accelerated and long term stability for 24 months has
term stability data till assigned shelf life been submitted for Sitagliptin phosphate monohydrate from M/s Zhejiang
shall be submitted for Sitagliptin Tianyu Pharmaceutical Co., Ltd. China.
phosphate monohydrate from M/s
Zhejiang Tianyu Pharmaceutical Co., Ltd.
China.
xiv. In contrary to reference product JanuMet We have used the same ingredients as the composition declared by
XR tablets firm has applied a seal coating Innovator for Janumet XR Tablet, and developed the Metformin HCl
upon Metformin extended release core, extended release core tablet at first then coat the Sitagliptin as immediate
clarification/justification shall be release layer on it.
submitted in this regard. However, in order to avoid the absorption of Sitagliptin into the
Metformin HCl extended release core tablet, a fine seal coat is applied
before the Sitagliptin layer. This seal coat also provides the protection to
the extended release properties of Metformin HCl core tablet. Ingredients
of this seal coat are same as declared by innovator for the composition of
Janumet XR Tablet.
Moreover, the CDP test has also performed, which revealed that the
dissolution profile of Jantovia XR is SIMILAR with the reference product
Janumet XR.
xv. Dissolution parameter of paddle speed i.e. We have followed the same test parameters as per the dissolution test
100rpm mentioned in Dissolution test of method adopted for routine dissolution testing of Metformin HCl extended
CDP is different from that recommended release tablet according to USP monograph
by USFDA i.e. 75 rpm.
xvi. As per decision of 278th meeting of At the beginning of products development Old versions of HPLC units
Registration Board firm claiming were used where Audit trail was not available. However, recently new
exemption from on site verification of HPLC units have procured those are 21 CFR compliant and onward testing
submitted stability data shall possess 21 is being performing on these HPLC units and audit trail is available for 9
CFR compliant system and complete audit months and 12 months testing. Copy of the analytical data with audit trail
trail report for test/analysis performed on is attached.
HPLC, confirmed/reported by panel which Therefore, we are requesting to grant exemption from on-site verification
has specifically inspected the of submitted stability data.
pharmaceutical unit for this purpose.
Since the complete audit trail has not been
reported in on-site verification report of
DASAVIR 60mg (Daclatasvir) Tablets and
also complete audit trail has not been
submitted for the instant applied
formulation so justification is required that
how exemption shall be granted from on-
site verification of submitted stability data.
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.
● Prof. Dr. Rafeeq Alam Khan, Meritorious Professor / Member Registration Board.
● Prof. Dr. Ghulam Sarwar, Dean, Faculty of Phamracy, Jinnah University for Women, 5-C, St-1,
Nazimabad, Karachi / Member Registration Board
● Affan Ali Qureshi, Assistant Director, CDL, DRAP, Karachi.
Registration Board directed the firm to perform dissolution test & Comparative Dissolution profile on stability
batches of all three strengths of Jantovia XR i.e. 50mg/500mg Tablet, 50mg/1000mg Tablet & 100mg/1gm Tablet,
as per USFDA recommendations.
Moroever Registration Board also advised the panel to verify and report regarding following observations:
i. Details of equipment used along with justification for its suitability for applying layer of Sitagliptin over
Metformin HCl extended release core, shall be submitted.
ii. Justification of 14% extra coating solution of Sitagliptin in master formulation (which is required to be based on
study/scientific rationale) for which firm has stated that it was prepared to compensate the coating losses during
API coating process of Sitagliptin.
iii. In-process testing for “Weight variation after film coating” has been performed on 26-05-2017, whereas date
mentioned on “Stability batch manufacturing record” for the process of film coating is 29-05-2017.
iv. Performance of dissolution test & Comparative Dissolution profile on stability batches of all three
strengths of Jantovia XR i.e. 50mg/500mg Tablet, 50mg/1000mg Tablet & 100mg/1gm Tablet, as per
USFDA recommendations.
Evaluator PEC-III
Sr. Name & Address Brand Name Type of Form, International Availability /
No. of Manufacturer / (Proprietary Name + Initial Diary & Date, Local Availability
Applicant Dosage Form + Strength), Fee (including
Composition, differential fee), GMP Inspection Report Date
Pharmacological Group, Demanded Price / & Remarks
Finished Product Pack size
Specification
953. M/s Atco Emazin Tablet 10mg Form 5-D Jardiance Tablet by Boehringer
Laboratories Ltd., Each film coated tablet Dy. No. 248 Ingelheim (USFDA Approved)
B-18, S.I.T.E., contains: 2-12-2014
Karachi Empagliflozin…..10mg PKR 50,000/- Panel inspection conducted on
(Anti diabetic) (2-12-2014) 21-07-2017 concludes that firm is
7’s, 10’s, 14’s, 20’s, operating at the good GMP
28’s and 30’s: compliance.
The firm has submitted stability study data along with required documents as per checklist approved in 251 st
meeting of Registration Board. Detailsof submitted data are as under:
(Dy.# 18457 dated 21-5-2018)
Drug Emazin Tablet 10mg
Name of Manufacturer M/s Atco Laboratories Ltd., B-18, S.I.T.E., Karachi
Manufacturer of API M/s Zhejiang Hongyuan Pharmaceutical Co. Ltd
API Lot No. 20170331
Description of Pack
3 x 10’s Alu-Alu blister, packed in unit carton.
Stability Storage Condition Real time : 30°C ± 2°C / 75% ± 5%RH
Time Period Real time: 6 months Accelerated: 6 months
Frequency Accelerated: 0, 1, 3, 6 (Months) Real Time: 0, 3, 6 (Months)
Batch No. 202G17 205G17 206G17

Batch Size 2500 Tablet 2500 Tablet 2500 Tablet
No. of Batches 03
Date of Submission Dy.# 18457 dated 21-5-2018
# Documents To Be Provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of Firm has submitted copy of GMP certificate of M/s Zhejiang
country of origin or GMP certificate of API Hongyuan Pharmaceutical Co. Ltd. Issued by China Food and
manufacturer issued by regulatory authority of Drug Administration China.
Firm has copy of a statement that Zhejiang Hongyuan
country of origin.
Pharmaceutical Co. Ltd., is sub company of Zhejiang Material
industry chemical group Co. Ltd.
The GMP certificate bearing number ZJ20130070 has been
verified from CFDA database
Yes
Yes
etc.
5. Documents confirming import of API etc. Firm has submitted ADC attested commercial invoice dated 26-
04-2017 of Empagliflozin 2.8Kg (Batch No. 20170331) from
Zhejiang materials industry chemical group Co. Ltd.
data / documents.
Yes
Yes
Rules, 1978.
Data for exemption from On-site investigation of submitted stability data
1. Reference of last onsite panel inspection for  Firm has referred to last inspection report for their product
instant dosage form conducted during last two Rofl 500mcg tablet which was considered in 277th meeting
years. of Registration Board. The inspection report confirmed 21
CFR compliant system and presence of complete audit trail
report.
This inspection report was initially presented in 275th meeting
in which Registration Board deferred the case for variation in
submitted data in DRAP and to the panel during onsite
inspection. The firm replied that they have mistakenly
mentioned wrong batch numbers on the data submitted in the
DRAP. The firm then submitted all revised, correct data and
requested to consider their product for approval.
2. Documents for the procurement of API with Firm has submitted ADC attested commercial invoice dated
approval from DRAP (in case of import). 26-04-2017 of Empagliflozin 2.8Kg (Batch No. 20170331)
from Zhejiang materials industry chemical group Co. Ltd.
3. Documents for the procurement of reference Firm has submitted commercial invoice of 100mg working
standard and impurity standards. standard adnd 20mg of impurity standard (A&C) of
empagliflozin.
Firm has submitted that since the quantities were very small
therefore the firm has directly procured through DHL.
4. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP certificate of M/s Zhejiang
manufacturer issued by regulatory authority of Hongyuan Pharmaceutical Co. Ltd. Issued by China Food
country of origin. and Drug Administration China.
Pharmaceutical Co. Ltd., is sub company of Zhejiang
Material industry chemical group Co. Ltd.
5. Mechanism for Vendor pre-qualification Firm has submitted copy of API management and acceptance
policy.
6. Certificate of analysis of the API, reference Firm has submitted certificate of analysis of API, working
standards and impurity standards standard and impurity standards.
7. Documents for the procurement of excipients Firm has submitted documents for procurement of excipients
used in product development? used in the product development.
8. List of qualified staff involved in product Firm has submitted list of technical staff in product
development with relevant experience. development section.
Production Data
9. Authorized Protocols/SOP for the development & Firm has submitted authorized protocols for product
stability testing of trial batches. development and stability testing.
10. Complete batch manufacturing record of three Firm has submitted complete batch manufacturing record of all
stability batches. the three batches.
11. Record of remaining quantities of stability Firm has submitted that 350 tablets of each batch are
batches. remaining.
QA/QC DATA
12. Record of Digital data logger for temperature and Firm has submitted record of digital data logger for
humidity monitoring of stability chambers (real temperature and humidity monitoring of stability chambers.
time and accelerated)
13. Method used for analysis of API along with COA. Firm has submitted method of analysis of API along with
COA.
14. Method used for analysis of FPP & complete Firm has submitted finished product specification and method
record of testing of stability batches (i.e. of analysis for testing of finished product.
chromatograms, lab reports, raw data sheets etc.)
15. Reports of stability studies of API from Firm has submitted stability study data of API.
manufacturer.
16. Analysis reports for excipients used. Firm has submitted analysis reports for excipients used.
17. Drug-excipients compatibility studies. Firm has submitted that their formulation is as per reference
product therefore they have not performed drug-excipient
compatibility studies.
18. Record of comparative dissolution data. Firm has submitted results and data lof comparative
dissolution profile at pH 1.2, 4.5 and 6.8. Firm has not
calculated factor f2 since more than 85% drug has been
released in 15 minutes.
19. Compliance Record of HPLC software 21CFR & Firm has submitted audit trail reports of all stability batches.
audit trail reports on product testing.
REMARKS OF EVALUATOR
Shortcomings communicated Firm’s response

Justify the specifications of dissolution (i.e. NLT 80% of Firm has submitted that they have adopted the
the labeled amount in 30 minutes) submitted under finished method from USP general chapter <1092> and
product specification, since FDA in its draft guidance for have set dissolution limit as NLT 80% of labelled
industry on dissolution testing of immediate release solid amount in 30 minutes. Based on the observations
oral dosage forms under “setting dissolution raised and the reference provided firm has agreed
specifications” have recommended “for highly soluble and to revise their dissolution limits to “NLT 85% of
rapidly dissolving drug products (BCS classes 1 and 3), a labelled amount in 30 minutes.
single-point dissolution test specification of NLT 85%
(Q=80%) in 60 minutes or less is sufficient as a routine
quality control test for batch-to-batch uniformity” (Ref:
https://www.fda.gov/downloads/drugs/guidances/ucm070
237.pdf)
Sr. Name & Address Brand Name Type of Form, International Availability /
No. of Manufacturer (Proprietary Name + Initial Diary & Date, Local Availability
/ Applicant Dosage Form + Strength), Fee (including
Composition, differential fee), GMP Inspection Report Date
Pharmacological Group, Demanded Price / & Remarks
Finished Product Pack size
Specification
954. M/s Atco Emazin Tablet 25mg Form 5-D Jardiance Tablet by Boehringer
Laboratories Ltd., Each film coated tablet Dy. No. 256 Ingelheim (USFDA Approved)
B-18, S.I.T.E., contains: 9-12-2014
Karachi Empagliflozin…..25mg PKR 50,000/- Panel inspection conducted on
(Anti diabetic) (9-12-2014) 21-07-2017 concludes that firm is
7’s, 10’s, 14’s, 20’s, operating at the good GMP
28’s and 30’s: compliance.
The firm has submitted stability study data along with required documents as per checklist approved in 251st
(Dy.# 18457 dated 21-5-2018)
Drug Emazin Tablet 25mg
Name of Manufacturer M/s Atco Laboratories Ltd., B-18, S.I.T.E., Karachi
Manufacturer of API M/s Zhejiang Hongyuan Pharmaceutical Co. Ltd
Description of Pack
3 x 10’s Alu-Alu blister, packed in unit carton.
Frequency Accelerated: 0, 1, 3, 6 (Months) Real Time: 0, 3, 6 (Months)
Batch No. 201G17 203G17 204G17

No. of Batches 03
1. COA of API Yes
2. Approval of API by regulatory authority of Firm has submitted copy of GMP certificate of M/s Zhejiang
country of origin or GMP certificate of API Hongyuan Pharmaceutical Co. Ltd. Issued by China Food and
manufacturer issued by regulatory authority of Drug Administration China.
country of origin.
Pharmaceutical Co. Ltd., is sub company of Zhejiang Material
industry chemical group Co. Ltd.
Yes
Yes
etc.
5. Documents confirming import of API etc. Firm has submitted ADC attested commercial invoice dated 26-
04-2017 of Empagliflozin 2.8Kg (Batch No. 20170331) from
Zhejiang materials industry chemical group Co. Ltd.
data / documents.
Yes
Yes
Rules, 1978.
Data for exemption from On-site investigation of submitted stability data
1. Reference of last onsite panel inspection for  Firm has referred to last inspection report for their product
instant dosage form conducted during last two Rofl 500mcg tablet which was considered in 277th meeting
years. of Registration Board. The inspection report confirmed 21
CFR compliant system and presence of complete audit trail
report.
This inspection report was initially presented in 275th meeting
in which Registration Board deferred the case for variation in
submitted data in DRAP and to the panel during onsite
inspection. The firm replied that they have mistakenly
mentioned wrong batch numbers on the data submitted in the
DRAP. The firm then submitted all revised, correct data and
requested to consider their product for approval.
2. Documents for the procurement of API with Firm has submitted ADC attested commercial invoice dated
approval from DRAP (in case of import). 26-04-2017 of Empagliflozin 2.8Kg (Batch No. 20170331)
from Zhejiang materials industry chemical group Co. Ltd.
3. Documents for the procurement of reference Firm has submitted commercial invoice of 100mg working
standard and impurity standards. standard adnd 20mg of impurity standard (A&C) of
empagliflozin.
The invoices are not ADC attested.
4. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP certificate of M/s Zhejiang
manufacturer issued by regulatory authority of Hongyuan Pharmaceutical Co. Ltd. Issued by China Food
country of origin. and Drug Administration China.
Pharmaceutical Co. Ltd., is sub company of Zhejiang
Material industry chemical group Co. Ltd.
5. Mechanism for Vendor pre-qualification Firm has submitted copy of API management and acceptance
policy.
6. Certificate of analysis of the API, reference Firm has submitted certificate of analysis of API, working
standards and impurity standards standard and impurity standards.
7. Documents for the procurement of excipients Firm has submitted documents for procurement of excipients
used in product development? used in the product development.
8. List of qualified staff involved in product Firm has submitted list of technical staff in product
development with relevant experience. development section.
Production Data
9. Authorized Protocols/SOP for the development Firm has submitted authorized protocols for product
&stability testing of trial batches. development and stability testing.
10. Complete batch manufacturing record of three Firm has submitted complete batch manufacturing record of all
stability batches. the three batches.
11. Record of remaining quantities of stability Firm has submitted that 350 tablets of each batch are
batches. remaining.
QA/QC DATA
12. Record of Digital data logger for temperature and Firm has submitted record of digital data logger for
humidity monitoring of stability chambers (real temperature and humidity monitoring of stability chambers.
time and accelerated)
13. Method used for analysis of API along with COA. Firm has submitted method of analysis of API along with
COA.
14. Method used for analysis of FPP & complete Firm has submitted finished product specification and method
record of testing of stability batches (i.e. of analysis for testing of finished product.
chromatograms, lab reports, raw data sheets etc.)
15. Reports of stability studies of API from Firm has submitted stability study data of API.
manufacturer.
16. Analysis reports for excipients used. Firm has submitted analysis reports for excipients used.
17. Drug-excipients compatibility studies. Firm has submitted that their formulation is as per reference
product therefore they have not performed drug-excipient
compatibility studies.
18. Record of comparative dissolution data. Firm has submitted results and data lof comparative
dissolution profile at pH 1.2, 4.5 and 6.8. Firm has not
calculated factor f2 since more than 85% drug has been
released in 15 minutes.
19. Compliance Record of HPLC software 21CFR & Firm has submitted audit trail reports of all stability batches.
audit trail reports on product testing.
Shortcomings communicated Firm’s response

Justify the specifications of dissolution (i.e. NLT Firm has submitted that they have adopted the
80% of the labeled amount in 30 minutes) method from USP general chapter <1092> and
submitted under finished product specification, have set dissolution limit as NLT 80% of
since FDA in its draft guidance for industry on labelled amount in 30 minutes. Based on the
dissolution testing of immediate release solid oral observations raised and the reference provided
dosage forms under “setting dissolution firm has agreed to revise their dissolution limits
specifications” have recommended “for highly to “NLT 85% of labelled amount in 30 minutes.
soluble and rapidly dissolving drug products
(BCS classes 1 and 3), a single-point dissolution
test specification of NLT 85% (Q=80%) in 60
minutes or less is sufficient as a routine quality
control test for batch-to-batch uniformity” (Ref:
https://www.fda.gov/downloads/drugs/guidances
/ucm070237.pdf)
Decision:
Registration Board decided to approve registration of “Emazin Tablet 10mg (Empagliflozin 10mg) and Emazin
Tablet 25mg (Empagliflozin 25mg) with revised specification including dissolution limit “Not Less Than 85% of
the labelled amount in 30 minutes” by M/s ATCO Laboratories Limited, B-18 SITE. 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. 07: Miscellaneous Cases
Evaluator PEC-VII
Typological error in name of the firm which is mentioned as Hamaz Pharma instead of cored
Gulf Pharm.
Following cases were discussed in 281 meeting of Registration Board and Deferred for evidence of
approval of applied formulation in reference regulatory authorities/agencies adopted by the
Registration Board in its 275th meeting and for clarification regarding use of banned excipient
(Methylene chloride), but during further proceedings it was found that there is a typological error in
name of the firm which is mentioned as Hamaz pharma instead of correct Gulf pharma Plot #49, Street#
S-5, National industrial zone, Rawat, Islamabad.
. The case is presented before the Board for reconsideration.
Name and address of manufacturer / M/s. Hamaz Pharmaceuticals (Pvt.) Ltd; 13 km, Bosan road,
955. Applicant Lutfabad, Multan
Brand Name +Dosage Form + Strength Artex-K 75

Diclofenac potassium…75mg
Diary No. Date of R& I & fee 6972 , 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
meeting.
 Methylene chloride is discontinued/banned excipients.
For this reason, revise the formulation is needed.
Decision: Registeration board corrected the name of appling firm from M/s. Hamaz Pharmaceuticals
(Pvt.) Ltd; 13 km, Bosan road, Lutfabad, Multan to Gulf pharma Plot #49, Street# S-5, National
industrial zone, Rawat, Islamabad.
Evaluator PEC-VI
956. Name and address of manufacturer / M/s. Cirin Pharmaceuticals, Hattar
Applicant
Brand Name +Dosage Form + Strength Mobiteck tablets
Misoprostol...…..200mcg
Diary No. Date of R& I & fee Dy. No.12; 18-3-2011; Rs.8,000/- Rs.12,000/- (14-11-2014)
Pharmacological Group (Cytoprotactant/NSAID)
Type of Form Form-5
Approval status of product in Reference Arthrotec by Pfizer USFDA
Me-too status Cytopan by Getz Pharma
GMP status Last inspection report 7-9-2016 GMP compliant.
Remarks of the Evaluator. Product was approved in M-264.
Later on it was identified that the product is approved in
USFDA as delayed release tablet that consists of a gastro-
resistant core containing 75mg of diclofenac sodium
surrounded by an outer mantle containing 200mcg misoprostol
along with box warning.
Whereas the firm has applied the product as plain tablet.
Decision: Deferred for submission of revised master formulation (as per Reference Regulatory
product) along with Form-5 and prescribed fee.
957. Name and address of manufacturer / M/s. Cirin Pharmaceuticals, Hattar
Applicant
Brand Name +Dosage Form + Strength Mobiteck tablets
Misoprostol..…..200mcg
Diary No. Date of R& I & fee Dy. No.33; 20-5-2011; Rs.8,000/- Rs.12,000/- (14-11-2014)
Pharmacological Group (Cytoprotactant/NSAID)

Type of Form Form-5
Approval status of product in Reference Arthrotec by Pfizer USFDA
Me-too status Cytopan by Getz Pharma
GMP status Last inspection report 7-9-2016 GMP compliant.
Remarks of the Evaluator. Product was approved in M-264.
Later on it was identified that the product is approved in
USFDA as delayed release tablet that consists of a gastro-
resistant core containing 50mg of diclofenac sodium
surrounded by an outer mantle containing 200mcg misoprostol
along with box warning.
Whereas the firm has applied the product as plain tablet.
Decision: Deferred for submission of revised master formulation (as per Reference Regulatory
product) along with Form-5 and prescribed fee.
Case. No. 8: M/s Tagma Pharma (Pvt.) Ltd. Lahore. (New Section)
CLB in its 261st meeting held on 2nd May, 2018 has considered and granted the following two (02)
additional section of M/s Tagma Pharma (Pvt.) Ltd.
1 Tablet section 03 03
(Psychotropic/ Narcotic)
2 Capsule section 01 01
(Psychotropic/ Narcotic)
Tablet section (Psychotropic/ Narcotic)
958. Name and Address of Manufacturer / M/s Tagma Pharma (Pvt.) Ltd. 2.5 km, Raiwind Road, Lahore.
Applicant
Brand Name + Dosage Form + Strength Loraz Tablets 1mg
Diary No. Date of R & I & fee Diary No:21956 ,25/06/2018,
Rs: 8,000/- (Duplicate 23-05-2011)
Rs: 12,000/- (Original 25-06-2018)
Lormetazepam…1mg
Type of Form Form-5
Approval Status of Product in Reference Lormetazepam 1 mg tablets by M/s Winthrop Pharmaceuticals
Me-too Status Lyzapam 1mg Tablets by M/s Atco Laboratories (Reg#
029875)
Follow up inspection
959. Name and Address of Manufacturer / M/s Tagma Pharma (Pvt.) Ltd.
Applicant 2.5 km, Raiwind Road, Lahore.
Brand Name + Dosage Form + Strength Teva Tablets 1mg
Rs: 8,000/- (Duplicate 23-05-2011)
Rs: 12,000/- (Original 25-06-2018)
Lorazepam…1mg
Type of Form Form-5
Approval Status of Product in Reference Lorazepam 1mg Tablets by M/s Genus Pharmaceuticals
Regulatory Authorities. Holdings Limited (MHRA Approved)
Me-too Status Gtvan 1mg Tablets by M/s Glitz Pharmaceuticals (Reg#
081419)
Brand Name + Dosage Form + Strength Zeen Tablets 30mg
Rs: 8,000/- (Duplicate 23-05-2011)
Rs: 12,000/- (Original 25-06-2018)
Phenobarbitone…30mg
Pharmacological Group Barbiturates and derivatives
rd
477
Type of Form Form-5
Approval Status of Product in Phenobarbital 30mg Tablets by M/s Relonchem Limited
Me-too Status Phenobarbitone Tablet 30mg by M/s Bayer (Reg# 000033)
Capsule section (Psychotropic/ Narcotic)
Brand Name + Dosage Form + Strength Azeep Capsules 30mg
Rs: 8,000/- (Duplicate 23-05-2011)
Rs: 12,000/- (Original 25-06-2018)
Temazepam…30mg
Type of Form Form-5
Approval Status of Product in Temazepam capsule 30mg by M/s Mylan Pharmaceuticals Inc.
Reference Regulatory Authorities. (USFDA Approved)
Me-too Status Restoril 30mg Capsules by M/s SANDOZ (Reg# 009685)
REGISTRATION-I SECTION.
HUMAN CASES
Case.No.1:- Request of M/s. Novartis Pharma (Pakistan) Limited, Karachi for change of
manufacturing site of registered product.
M/s Novartis Pharma (Pakistan) Limited, 15 west wharf Road, Karachi has applied for change
of manufacturing site of their following already registered product as per details given below: -
Name & Composition Existing approved site
S. Reg. New Proposed Site / Manufacturer /
(as per COPP). (as per approval
No No. Product License Holder
letter)
1. 031390 Zometa 4mg/5ml concentrate Manufacturer: Name & Address of Manufacturer:
for solution for infusion. M/s Novartis Pharma M/s Fresenius Kabi Austria GmbH,
Each 5ml vial contains: - Stein AG, Hafnerstrasse 36, 8055 Graz, Austria.
Zoledronic acid 4mg. Switzerland. Marketing Authorization Holder:
(Corresponding to 4.264mg M/s Novartis Europharm Limited,
of Zoledronic acid Frimley Business Park, Camberley
monohydrate) GU16 7SR, UK.
The firm has submitted the following supporting documents: -
Application on Form-5A.
a) Fee of Rs.50,000/-
b) Copy of initial registration letter and renewal status.
c) Original and legalized COPP issued by EMA.
d) Copy of GMP certificate of new site.
Decision:- Registration Board approved the following changes with respect to registered
product Zometa 4mg/5ml concentrate for solution for infusion (Reg.No.031390)
subject to policy for imported finished drugs registration;
a. Change of manufacturer from M/s Novartis Pharma Stein AG, Switzerland to
M/s Fresenius Kabi Austria GmbH, Hafnerstrasse 36, 8055 Graz, Austria.
b. Marketing authorization holder as M/s Novartis Europharm Limited, Frimley
Business Park, Camberley GU16 7SR, UK.
Case.No.02:- Request of M/s. Otsuka Pakistan for change of manufacturing site and permanent
import permission in finished form of their already registered products.
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 / New Proposed Site / Product License
Existing Approved Site
No Composition / Reg. No. Holder (as per COPP)
1. Pletaal 50mgTablet Manufacturer: Name & Address of Manufacturer &
Each tablet contains: - M/s Otsuka Pharmaceutical Product License Holder:
Cilostazole……50mg. Co.,Ltd, Kandu Tsukasa- M/s Korea Otsuka Pharmaceutical Co., Ltd,
cho, Chiyoda-Ku, Tokyo, 27, Jeyakgongdan 3-gil, Hyangnam-eup,
Reg. No.029294. 1018535, Japan. Hwaseong-si, Gyeonggi-do, Republic of
Korea.
2. Pletaal 100mg Tablet -do- -do-
Each tablet contains: -
Cilostazole……100mg.
Reg. No.029295.
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:
i. 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.
ii. 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.
iii. 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.
iv. 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.
The case was discussed in 281st meeting of Registration Board and the Board decided as follow:
“Registration Board deferred the case for provision of fresh fee for the said purpose.”
The firm has now deposited fresh fee of Rs.100,000/- for each product. With reference to the
instant case it is also submitted that the firm mentions “under license from: Otsuka Pharmaceutical
Co., Ltd., 2-9, Kanda-Tsukasamachi, Chiyoda-ku, Tokyo, Japan”. However, the same is not neither
mentioned in CoPP nor on free sale certificate provided by the firm. The firm in support of this
statement provided a letter from Otsuka Japan wherein it has been declared that “we has given
permission/license to Korea Otsuka Pharmaceutical Co., Ltd to manufacture Pletal 50mg and 200mg
Tablets at their plant in Korea”.
Decision:- Registration Board approved the following changes with respect to registered
products Pletaal 50mg Tab (Reg.No. 029294) and Pletaal 100mg Tab (Reg.No.
029295);
a. Change of registration status/permission from bulk import and local repacking
to import in finished form.
b. Change of manufacturing site from M/s Otsuka Pharmaceutical Co.,Ltd, Kandu
Tsukasa-cho, Chiyoda-Ku, Tokyo, 1018535, Japan to M/s Korea Otsuka
Pharmaceutical Co., Ltd, 27, Jeyakgongdan 3-gil, Hyangnam-eup, Hwaseong-
si, Gyeonggi-do, Republic of Korea subject to policy for imported finished drugs
registration.
c. Product license holder as M/s Korea Otsuka Pharmaceutical Co., Ltd, 27,
Jeyakgongdan 3-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Republic of
Korea.
Case No. 03: Request of M/s. Chiesi Pharmaceuticals (Pvt) Ltd, Lahore for Correction of
Typographic error in registration letter- Clenil Compositum (Reg.No. 021199).
M/s. Chiesi Pharmaceuticals (Pvt) Ltd, Lahore has stated that their product Clenil Compositum
for aerosol nebulizing suspension was granted registration in 09-09-1998 bearing Registration No.
021199. The firm informed that there is a typographic error in registration letter i.e. 100 ml was
enclosed in bracket while it should be out of brackets (details mentioned in table below). Now firm has
requested to rectify the typographic error in order to avoid delay in shipment clearance process.
The firm has submitted following supporting documents: -
i) Copy of initial registration letter.
ii) Legalized COPP issued by Italian authrorities (AIFA).
iii) Fee of Rs.5000/-.
Details of composition is as under: -
Composition as per initial registration letter Composition as per COPP

Contains: - Each 100 ml suspension contains:-
Beclomethasone Dipropionate…40mg Beclomethasone Dipropionate…40mg
Salbutamol sulphate….. 96.40mg (eq to solbutamol base Salbutamol sulphate….. 96.40mg
80.00/100ml) (corresponding to solbutamol base 80mg)
The case was considered in 9th PRVC meeting and the committee decided to place the case
before Registration Board for further consideration.
Decision:- Registration Board approved request of M/s. Chiesi Pharmaceuticals (Pvt) Ltd,
Lahore for correction in composition of registered product Clenil Compositum
(Reg.No.021199) as per following details on same terms and conditions.
Composition as per initial registration letter Corrected Composition (as per CoPP)
Contains: - Each 100 ml suspension contains:-

Beclomethasone Dipropionate…40mg Beclomethasone Dipropionate…40mg
Salbutamol sulphate….. 96.40mg (eq to Salbutamol sulphate….. 96.40mg
solbutamol base 80.00/100ml) (corresponding to solbutamol base 80mg)
Case.No.04:- Request of M/s. ICI Pakistan Ltd, Karachi for approval of packaging site for
already registered products.
M/s ICI Pakistan Ltd, Karachi has requested for approval of packing site for their already
registered product as per following details: -
Sr. Product Name Composition (as per
Existing Site New Proposed Site (s)
No & Reg. No CoPP)
1. Seroquel tablet Each film coated Manufacturer: Manufacturer:
25mg tablet contains: M/s AstraZeneca M/s AstraZeneca Pharmaceutical
Quetiapine……25mg Pharmaceutical Company Limited, No.2 Huangshan
Reg. No. (as Quetiapine Company Limited, Road, Wuxi, Jiangsu, China.
025269 fumarate..28.780mg) No.2 Huangshan Packager:
Road, Wuxi, M/s Astrazeneca UK Limited, Silk
Jiangsu, China. Road Business Park,Macclesfield
Cheshire, SK 10 2NA UK.
Product License Holder:
M/s Astrazeneca UK Limited, 600
Capability Green, Luton LU1 3LU,
United Kingdom
2. Seroquel tablet Each film coated
100mg. tablet contains: -do- -do-
Quetiapine…….100
Reg. No. mg
025270 (as Quetiapine
Fumarate
…115.130mg)
3. Seroquel tablet Each film coated
200mg tablet contains: -do- -do-
Quetiapine…...
Reg. No. 200mg
025298 (as Quetiapine
fumarate…..230.260
mg)
The firm has submitted fee of Rs.100,000/- for each product and provided following supporting
documents:-
Application on Form 5A.
i. Initial registration letters & renewal status.
ii. Original valid & legalized CoPP issued by MHRA.
iii. Site master plan of the manufacturer.
Decision:- Registration Board approved the following changes with respect of registered
products Seroquel Tablet 25mg (Reg.No. 025269), Seroquel Tablet 100mg
(Reg.No. 025270) and Seroquel Tablet 200mg (Reg.No. 025298);
a. Addition of packaging site as M/s Astrazeneca UK Limited, Silk Road
Business Park, Macclesfield Cheshire, SK 10 2NA UK subject to policy for
imported finished drugs registration. The already approved manufacturer
i.e M/s AstraZeneca Pharmaceutical Company Limited, No.2 Huangshan
Road, Wuxi, Jiangsu, China shall remain the same.
b. Product license holder as M/s Astrazeneca UK Limited, 600 Capability
Green, Luton LU1 3LU, United Kingdom.
Case.No.05:- Registration of Products of M/s. Muller & Phipps Pakistan (Pvt) Ltd, Karachi.
Registration Board in its 272nd meeting approved the following products of M/s. Muller &
Phipps Pakistan (Pvt) Ltd, Karachi as per decision mentioned alongside each.
S.N Name of Product Name and Demanded Pack Decision of Board/remarks
importer/manufacturer Composition Size and MRP
1. M/s Muller &Phipps Pakistan PARACETAMOL Pack of 10 vials Approved as per Import Policy
(PVT) Ltd. Uzma Court, Main KABI 10mg/ml (50ml vial) for Finished Drug with
Clifton Road , Karachi (50ml vial) specifications as approved in
Manufacturer: Solution for IV 131.826/- per vial reference country (Germany)
M/s Fresenius Kabi Austria Infusion with the submission of original,
GmbH Hafnerstrabe 36, 8055 legalized and valid CoPP. The
Graz, Austria. Each ml Contains: Chairman of Registration Board
Marketing authorization Paracetamol…10mg will be authorized to issue the
holder: registration letter after the
M/s Fresenius Kabi Analgesic and submission of valid legalized
Deutschland GmbH, D-61346 antipyretic CoPP.
Bad Homburg v. d. H. / In House
Germany (CoPP) 2 years
2. M/s Muller &Phipps Pakistan PARACETAMOL Pack of 10 vials Approved as per Import Policy
(PVT) Ltd. Uzma Court, Main KABI 10mg/ml (100ml vial) for Finished Drug with
Clifton Road , Karachi (100ml vial) specifications as approved in
Manufacturer: Solution for IV 131.826/- per vial reference country (Germany)
M/s Fresenius Kabi Austria Infusion with the submission of original,
GmbH Hafnerstrabe 36, 8055 legalized and valid CoPP. The
Graz, Austria. Each ml Contains: Chairman of Registration Board
Marketing authorization Paracetamol… will be authorized to issue the
holder: 10mg registration letter after the
M/s Fresenius Kabi submission of valid legalized
Deutschland GmbH, D-61346 Analgesic and CoPP.
Bad Homburg v. d. H. / antipyretic
Germany (CoPP) In House
2 years
With reference to the above mentioned products the following details are submitted;
a. Firm has informed that the manufacturer for product at Sr.No.1 is M/s Fresenius Kabi
Austria GmbH Hafnerstrabe 36, 8055 Graz, Austria while for product at Sr.No.2 the
demanded manufacturing site (as per Form-5A and CoPP) is M/s. Fresenius Kari
Deutschland GmbH, Freseniusstrasse 1, D-61169 Friedberg, Germany. But in minutes
of Reg. Board meeting, for both the products, the manufacturer is mentioned as “M/s
Fresenius Kabi Austria GmbH Hafnerstrabe 36, 8055 Graz, Austria”. The product
license holder for both products are the same.
b. Furthermore, for both products the decision of Reg. Board mentioned as “Approved as
per Import Policy for Finished Drug with specifications as approved in reference
country (Germany) with the submission of original, legalized and valid CoPP. The
Chairman of Registration Board will be authorized to issue the registration letter after
the submission of valid legalized CoPP”, however, as per CoPP’s received, the CoPP
for product at Sr.No.2 is valid upto Aug, 2018.
Decision:- Registration Board approved the following corrections in the minutes of 272 nd
Registration Board meeting with respect of above mentioned approved products:
a. Manufacturer for the product at Sr.No.1, in accordance with CoPP and Form-
5A is M/s. Fresenius Kabi Deutschland GmbH, Freseniusstrasse 1, D-61169
Friedberg, Germany. While for product at Sr.No.02 the manufacturer is M/s
Fresenius Kabi Austria GmbH Hafnerstrabe 36, 8055 Graz, Austria. Product
license holder for both products is M/s Fresenius Kabi Deutschland GmbH, D-
61346 Bad Homburg v. d. H., Germany.
b. For product at Sr.No.2 the available CoPP is valid, therefore, registration letter
shall be processed accordingly. While for product at Sr.No.1, registration letter
shall be processed after submission of valid and legalized CoPP and Chairman
of Registration Board will be authorized to issue the registration letter after the
submission of valid legalized CoPP.
Case.No.06:- Request of M/s. OBS Pakistan (Pvt) Ltd, Karachi for Change in product
license holder for registered products.
M/s. OBS Pakistan (Pvt) Ltd, Karachi has informed that product license holder of their
registered products Venofer IV injection and Ferinject Injectable, for non-European Economic Area
(EEA) countries, has been changed as per following details.
S.# Regn. Name/ Composition Name of current Product Name of proposed Product
No. License Holder / License Holder /
Manufacturer Manufacturer
1. 085032 Ferinject Injectables Product License Holder Product License Holder
Each 10ml vial M/s. Vifor France, 100-101 M/s. Vifor (International)
contains: Terrasse Boieldieu, Tour Inc., Rechenstrasse 37, 9014
Iron as ferric Franklin la Defense 8, Paris La Sr., Gallen, Switzerland.
carboxymaltose…500 Defense Cedex 92042, France. Manufacturer:-
mg Manufacturer:- M/s. IDT Biologika GmbH,
M/s. IDT Biologika GmbH, Am Am Pharmapark, 06861
Pharmapark, 06861 Dessau- Dessau-Rosslau, Germany.
Rosslau, Germany.
2. 085031 Venofer I.V injection Product License Holder Product License Holder
Each 5ml Ampoule M/s. Vifor France, 100-101 M/s. Vifor (International)
contains: Terrasse Boieldieu, Tour Inc., Rechenstrasse 37, 9014
Franklin la Defense 8, Paris La Sr., Gallen, Switzerland.
Iron sucrose … 100mg
Defense Cedex 92042, France Manufacturer:
Manufacturer: M/s. Takeda Austria GmbH.,
M/s. Takeda Austria GmbH., St. St. Peter-Strasse 25, 4020
Peter-Strasse 25, 4020 Linz, Linz, Austria
Austria
The firm has deposited fee of Rs.5,000/- for each product and submitted with the following
supporting documents:-
a. Copy of initial registration letters.
b. Original and legalized COPPs issued by Swissmedic for both products.
c. Letter of authorization in favour of M/s. OBS Pakistan Pvt Ltd, Karachi for being the
distribution and promotion agent of both above mention products.
d. Declaration of M/s. Vifor (international) Inc., Rechenstrasse 37, 9014 Sr., Gallen,
Switzerland as Marketing authorization holder for non-EEA countires by M/s. Vifor
Pharma International.
Decision:- Registration Board approved firm’s request for change of marketing authorization
holder for registered products Ferinject Injectables (Reg.No. 085032) and Venofer
I.V injection (Reg.No. 085031) from M/s. Vifor France, 100-101 Terrasse
Boieldieu, Tour Franklin la Defense 8, Paris La Defense Cedex 92042, France to
M/s. Vifor (International) Inc., Rechenstrasse 37, 9014 Sr., Gallen, Switzerland on
same terms and conditions.
Case.No.07: Request of M/s GSK Pakistan Ltd, Karachi for Change of Manufacturing/
Packaging Site of their Registered Product.
M/s. GlaxoSmithKline Pakistan Limited, Karachi has requested for change of
manufacturing/Packaging site of their following already registered imported human product as per
details mentioned below:-
S. Reg. Name of Products Existing Approved site New Proposed site
No. No.
1. 009974 Zovirax Tablet Manufacturing site: Manufacturing/Packaging
Each tablet contains: M/s. Glaxo Wellcome S.A., site:
Acyclovir…200mg Aranda, Spain. M/s. Glaxo Wellcome, S.A.
Packging Site: Avda. Extremadura, 3, Pol.
GlaxoSmithKline Australia Ind. Allendeduero, Aranda de
Pty Ltd., Boronia, Australia. Duero, 09400 Burgos Espana.
The firm has initially submitted fee of Rs.50,000/- and later differential fee of Rs.50,000/-.
Copy of fee challan of Rs.50,000 submitted initally is available. The firm has submitted following
supporting documents:
i) Application on Form 5A.
ii) Copies of initial registration letter and renewal status.
iii) Original & legalized CoPP issued by Spanish authorities.
As per CoPP issued by Spanish authorities, the product Zovirax is not authorized for free sale
in Spain. However, the firm has now provided original, valid & legalized CoPP for the said product
issued by French Authority wherein it has been mentioned that the product Zovirax is on free sale in
France.
Decision: Registration Board approved the change of manufacturer/packaging site for

registered product Zovirax Tablet (Reg.No. 009974) as per following details
subject to policy for imported finished drugs registration and verification of fee
challan of Rs.50,000/- submitted initially, in the light of procedure prescribed by
Registration Board in its 264th meeting for verification of duplicate fee challan;
S. Reg. Name of Products Previous site(s) New Approved site
No. No.
1. 009974 Zovirax Tablet Manufacturing site: Manufacturing/Packaging
M/s. Glaxo Wellcome site:
Each tablet contains: S.A., Aranda, Spain. M/s. Glaxo Wellcome,
Acyclovir…200mg Packging Site: S.A. Avda. Extremadura,
GlaxoSmithKline 3, Pol. Ind. Allendeduero,
Australia Pty Ltd., Aranda de Duero, 09400
Boronia, Australia. Burgos Espana.
Case.No.08: Request of M/s. Novartis Pharma (Pakistan) Limited, Karachi for Registration of
Drugs.
M/s. Novartis Pharma (Pakistan) Limited, Karachi has requested for registration of following
products in their name. These products were approved in various meetings of Registration Board in
favor of M/s. Ali Gohar & Company (Pvt) Ltd, State Life Building 1B, I.I. Chundrigar Road, Karachi
for import in finished form.
Product-1: Simbrinza Eye Drops Suspension
Sr.
Name / detail of documents Documents / information provided by firm
No.
1. Product Name / Composition Simbrinza Eye Drops Suspension
Each ml of suspension contains:
Brinzolamide…10mg
Brimonidine Tartrate… 2mg
(eq. to 1.3mg Brimonidine)
2. Name and address of Applicant M/s. Novartis Pharma (Pakistan) Limited, 15 West Wharf,
(transferee) Dockyard Road, Karachi.
3. Name of Transferor M/s. Ali Gohar & Company (Pvt) Ltd, State Life Building 1-B, I.I.
Chundrigar Road, Karachi
4. Detail of Drug Sale License Address: M/s Novartis Pharma (Pakistan) Limited, 15 West Wharf,
Dockyard Road, Karachi.
5. Name and address of manufacturer As per COPP:-
M/s. SA Alcon-Courveur NV, Rijksweg 14, BE-2870 Puurs,
Belgium.
6. Name and address of marketing M/s. Novartis Europharm Ltd, Frimley Business Park, Camberley
authorization holder GU16 7SR, United Kingdom
7. Name of exporting country Belgium
8. Diary No. & Date of R& I Dy. No. 5938 Dated 19/02/2018
9. Fee submitted Rs.50,000/- Challan No.0618103
10. Finished Product Specification In house specification
11. Shelf life 24 months (as per Form-5A/CoPP issued by EMA)
12. Pack Size Not provided
13. Remarks  The said product was approved in 268th Registration Board
meeting in favour of M/s. Ali Gohar & Company (Pvt)
Ltd., Karachi.
 Product has been referred to Costing & Pricing Division
for MRP fixation.
Product-2: Azarga Eye Drops Suspension
Sr.
Name / detail of documents Documents / information provided by firm
No.
1. Product Name / Composition Azarga Eye Drops Suspension
Each ml of suspension contains:
Brinzolamide…………10mg
Timolol Maleate………5mg
2. Name and address of Applicant M/s. Novartis Pharma (Pakistan) Limited, 15 West Wharf,
(transferee) Dockyard Road, Karachi.
3. Name of Transferor M/s. Ali Gohar & Company (Pvt) Ltd, State Life Building 1-B,
I.I. Chundrigar Road, Karachi
4. Detail of Drug Sale License Address: M/s Novartis Pharma (Pakistan) Limited, 15 West
Wharf, Dockyard Road, Karachi.
5. Name and address of manufacturer As per COPP:-
M/s. SA Alcon-Courveur NV, Rijksweg 14, B-2870 Puurs,
Belgium.
6. Name and address of marketing M/s. Novartis Europharm Ltd, Frimley Business Park, Camberley
authorization holder GU16 7SR, United Kingdom
7. Name of exporting country Belgium
8. Diary No. & Date of R& I Dy. No. 5937 Dated 19/02/2018
9. Fee submitted Rs.50,000/- Challan No.0618104
10. Finished Product Specification In house specification
11. Shelf life 24 months (as per Form-5A/CoPP issued by EMA)
12. Pack Size Not provided.
13. Remarks  The said product was approved in 246th Registration
Board meeting in favour of M/s. Ali Gohar & Company
(Pvt) Ltd., Karachi.

a. Fee of Rs.50,000/- for each product.
b. Applications on Form-5A.
c. Original and legalized CoPPs.
d. Copy of GMP certificate.
e. Original NOC from existing registration holder (date: 11-12-2017).
f. Termination letter from manufacturer/MAH of the said products to existing
registration holder.
g. Letter of authorization from M/s. Novartis Pharma AG, Switzerland to M/s.
Novartis Pharma (Pakistan) Limited, Pakistan.
Decision:- Registration Board decide as follow:

a. Approved the cancellation of approval of above mentioned products from
the name of M/s Ali Gohar & Company (Pvt) Ltd, State Life Building 1-B,
I.I. Chundrigar Road, Karachi.
b. Approved the registration of above mentioned products in the name of M/s.
Novartis Pharma (Pakistan) Limited, 15 West Wharf, Dockyard Road,
Karachi.
Case.No.09:- Request for exemption of labeling requirements.

A. M/s. Sanofi-aventis Pakistan Limited, Karachi
M/s. Sanofi-aventis Pakistan Limited, Karachi has informed that their registered
product “Fludara 50mg Powder for injection” (Reg.No.088890) is being manufactured and primarily
packed in large volume at the source point, then it is supplied to UK for secondary packaging from
where supplies are made to various countries according to their needs.
S.# Regn. No. Name of Product/ Source
Composition
1. 088890 Fludara 50mg Manufacturing & Primary Packaging Site:
Powder for injection M/s. Baxter Oncology GMBH, Kantstrasse 2, Halle/Westfalen,
33790, Germany.
Labeling/Secondary Packaging & Releasing Site:
M/s. Genzyme Limited, 37 Hollands Road, Haverhill, Suffolk CB9
8PU, United Kingdom.
M/s. Genzyme Europe BV, Gooimeer 10, NL 1411 DD, Naarden, The
Netherlands.
The firm has requested to grant them permission for import of the above mentioned product
in Standard Export Packs and subsequent local reprinting of Registration Number and MRP.
Further, the firm has provided local SOP for “Control of Repacking Operations” and sales
record of years 2012, 2013, 2014 and 2015. Details are as under:
S Product No of units import No of units sold Sales record (units)
# Name 2012 2013 2014 2013 2014 2015 MAT MAT MAT
Q32015 Q32016 Q32017
1 Fludara 50mg 400 250 497 332 334 226 Not 222 Not
injection available available
The firm has provided details regarding the local reprinting of the details at the licensed
premises i.e M/s. Sanofi-aventis Pakistan Limited, plot No.23, Sector No.22, Korangi Indutrial Area,
Karachi. The firm was advised through Mr. Nadeem Alamgir, atteding the meeting as representative
of Pharma Bureau, to depsoit the requisite fee and submit evidance of deposition in DRAP before
closing hours till 29-06-2018.
Decision:- Registration Board deferred the case for provision of requisite fee for processing
of firm’s request.
B. M/s. Novartis Pharma (Pakistan), Karachi

M/s. Novartis Pharma (Paksitan), Karachi has informed that due to restricted usage of
following registered products it is not feasible for the principle manufacturer to develop Pakistan
Specific packs in small quantities. Details along with estimated 2018 sales forcast (provided by the
firm) are as under:
S.No Product Name Reg.No Annual Approx Pack size

Quantities for import
1. Stalevo 50/12.5/200mg Tablets 087625 900 packs 30’s
Each film coated tablets
contains:-
Levodopa…50mg
Carbidopa…12.5mg
Entacapone…200mg
2. Stalevo 100/25/200mg Tablets 087626 1200 packs 30’s
contains:-
Levodopa...100mg
Carbidopa…25mg
Entacapone…200mg
3. Stalevo 150/37.5/200mg Tablets 088879 1200 packs 30’s
contains:-
Levodopa...150mg
Carbidopa…37.5mg
Entacapone…200mg
Keeping in view the above position, the firm has requested for:
a. Exemption from urdu text on import of Stalevo international packs.
b. Local reprinting of registration number and MRP through laser jet at licensed premises of
M/s. Novartis Pharma (Pakistan) Limited, situated at 15th West Wharf (DML # 000193)
before releasing Stalevo international packs from warehouse.
The firm was advised through Mr. Nadeem Alamgir, atteding the meeting as representative
of Pharma Bureau, to depsoit the requisite fee and submit evidance of deposition in DRAP before
closing hours till 29-06-2018. Mr. Nadeem Alamgir has informed that the firm had deposited the fee
of Rs.5000/- for each product, on the advice of Registration Board, dated 29-06-2018 (Challan.No’s:
0530427, 0530428 and 0530429) and the recept in DRAP was also confirmed.
Decision:- Keeping in view the limited usage of the above-mentioned product, Registration
Board acceded to firm’s request for import of Stalevo 50/12.5/200mg Tablets
(Reg.No. 087625), Stalevo 100/25/200mg Tablets (Reg.No. 087626) and Stalevo
150/37.5/200mg Tablets (Reg.No. 088879) without urdu text, registration number
& MRP and printing the same at the licensed premises of M/s. Novartis Pharma
(Pakistan) Limited, 15th West Wharf (DML #000193) before sale/release into the
market in compliance to Drug (Labeling and Packing) Rules, 1986 on same terms
and conditions. This permission is for the period of two years only and in the
mean time the firm will make necessary arreangemnts for ensuring import of
packs with all requisite information in complaince to Drug (Labelling &
Packaging) Rules, 1986.
Case No. 10: IMPORT OF DRUGS IN FINISHED FORM FROM

TAIWAN/INSPECTION OF MANUFACTURER ABROAD.
Registration Board in 261st meeting approved under mentioned drug to be manufactured by the
firm located in Taiwan.
S. No. Name of Importer/ Name of drug (s)/
Manufacturer. Composition
1. M/s. Otsuka Pakistan Ltd. Meptin Tablets
30-B, S.M.C.H.S., Karachi. Each tablet contains:-
Factory: F/4-9, Hub Industrial Trading Estate (H.I,T,E), Procaterol Hydrochloride Hydrate
Distt. Lasbella, Balochistan. JP……..50mcg
M/s. Taiwan Otsuka Pharmaceutical Co. Ltd. Chung-Li
Fac tory 15, Jyi-Lin Road, Chung-Li, Taoyuan County,
Taiwan, R.O.C.
Under License from:-
M/s. Otsuka Pharmaceutical Co. Ltd., 2-9, Kanda-
Tsukasamachi, Chiyoda-ku, Tokyo, Japan.
Subsequently a two members panel was approved for inspection of the manufacturer as per
procedure. However, further processing of the matter was withheld as the policy regarding import and
official visits of Pakistani official to Taiwan required clarification as Pakistan do not have formal
diplomatic ties with Taiwan.
Accordingly, following clarification was sought from Ministry of Foreign Affairs.
i.Whether there are any restrictions on the importation of medicines from Taiwan.
ii.Whether there are any restrictions on government officers of Pakistan for visiting
Taiwan for official purpose.
In response Ministry of Foreign Affairs provided a copy of the policy guidelines on Taiwan.
The relevant portions of the policy are described as under:-
Pakistan does not recognize Taiwan as a separate entity but part of China.
 Accordingly, Pakistan does not have any diplomatic/consular relations with Taiwan.
Similarly, no official contact, of any type, is maintained with Taiwan.
 The term “Republic of China” cannot be used in any form/communication which might
imply recognition of Taiwan. If necessary, it instead can be referred to as “Taiwan,
China” or “Chinese Taipe”.
 No official contacts are allowed with Taiwan.
 Trade is conducted strictly on un-official basis and through private sector only.
 No direct contacts to be made with the Taiwan authority agencies.
 No Pakistan Government functionary can visit Taiwan.
 No Taiwan authority functionary can visit Pakistan.
 Government /official investment from Taiwan is not allowed in to Pakistan.
 Exchange of delegations(s) is not allowed.
 Holding of trade exhibitions, establishment of display centers is not allowed.
 No publicity is given to Pakistan’s trade or commercial contacts with Taiwan.
Decision:- Keeping in view the above position, Registration Board deferred the case for
seeking clarification/comments of applicant with reference to
importability/registration of product in question in view of the policy guidelines
provided by M/o. Foreign Affairs.
VETERINARY
Case No. 11: Request for grant of additional pack sizes for already registered veterinary drugs.
M/s. Bio-Labs (Pvt) Ltd., Islamabad has applied for approval of additional packs of their
registered veterinary drug as per details mentioned against each:-
S.No. Regn. Name of Drug(s)/Composition Already Demanded Justification
No. Granted Additional
Pack Pack(s)
Size(s)
1. 048122 Lions-Mox-C Water Soluble Powder 100gm 1.5 Kg Due to market
Each 100gm contains:- 250gm 5 Kg demand of
AmoxycillinTrihydrate equivalent to 500gm additional
Amoxycillin base……………………15gm 1000gm pack.
ColistinSulphate……50 MIU
2. 046568 Biotil Liquid 60ml 5 Litre -do-
Each ml contains:- 250ml
Tilmicosin (as Phosphate)………….250mg 500ml
1000ml
M/s. Bio-Labs (Pvt) Ltd., Islamabad has deposited the required fee of Rs.5,000 x 3 =
Rs.15,000/- and submitted following supporting documents:-
(i) Copies of registration letters.
(ii) Renewal status of drugs.
(iii) Copy of Drug Manufacturing License.
(iv) Copy of approved section.
(v) Copy of CRF.
(vi) Copy of inspection report.
The demanded packs are not given to other firms.

Decision:- Registration Board referred the case to Expert Working Group on Veterinary
drugs for further consideration.
Case No. 12: Request for grant of additional pack sizes for already registered veterinary drugs.
M/s. Wimits Pharmaceuticals, Lahore has applied for approval of additional packs of their
registered veterinary drug as per details mentioned against each:-
S.No. Regn. Name of Drug(s)/Composition Already Demanded Justification
No. Granted Additional
Pack Size(s) Pack(s)
1. 087092 Minvet Granules 500g 5 Kg Due to market
Each Kg contains:- 1Kg 10 Kg packing 5
Vitamin A……………….…0.8gm 20 Kg Kg,10 Kg &
Vitamin D3……………….0.16gm 20 Kg
Vitamin E…………………0.38gm granules.
Vitamin B1………………...1.0gm
Vitamin B2……………….1.25gm
Vitamin B12…………….0.001gm
Vitamin B3……………….6.25gm
Copper Sulphate………….0.25gm
Magnesium Sulphate……….25gm
Calcium Chloride……......0.023gm
Zinc Sulphate…………......2.17gm
Manganese Sulphate……......10gm
Potassium Iodide……….......0.5gm
Sodium Selenite………......0.01gm
Phosphorus…………...........150mg
Sodium Chloride………......120gm
VitaminB6……………….......4gm
(As per Innovator's Specification*)
M/s. Wimits Pharmaceuticals, Plot No.129, Sunder Industrial Estate (P.I.E) Raiwind Road,
Lahore has deposited the required fee of Rs.5,000 x 3 = Rs.15,000/- and submitted following supporting
documents:-
(i) Copy of registration letter.
(ii) Affidavit.
(iii) Copy of Drug Manufacturing License.
(iv) Copy of CRF.
(v) Label.
The demanded packs are not given to other firms.
Decision:- Registration Board referred the case to Expert Working Group on Veterinary
drugs for further consideration.
Case No. 13: Request of M/s. Ghazi Brothers, Karachi for Correction of
Composition/Manufacturer.
Registration Board in its 260th meeting approved the following imported veterinary product of
M/s. Ghazi Brothers, Karachi as per decision mentioned alongside. The processing of the registration
letter was withheld for correction of composition/manufacturer as per following details:
S. Approved Name Claimed to be Product Claimed to be Shelf Life
No. of Applicant/ Applied for Composition Applied for & Pack
Manufacturer Approved in Size
as per Minutes Minutes
(I) (II) (III) (IV) (V) (VI)
1. M/s. Ghazi M/s. Ghazi Spectramast DC Spectramast DC 24
Brothers, Brothers, Suspension Sterile months as
Karachi- Karachi-75350. / Each 10ml Plastet Suspension per CoPP
75350. / M/s. Zoetis Inc. Disposable Syringe Each 10ml
M/s. Pharmacia 2605 East Kilgore contains:- contains:- 10ml
& Upjohn Road Kalamazoo, Ceftiofur Equivalents Ceftiofur
Company A Michigan, 49001, (as the hydrochloride hydrochloride
Division of USA. sale)…500mg equivalent
Pfizer Inc. (Antibiotic). to..500mg of
Kalamazoo, Manufacturer’s ceftiofur
Michigan, U.S.A. specifications (Antibiotic).
Manufacturer’s
specifications
The firm has requested for correction of typographical error in minutes of 260th meeting of
Registration Board as per position mentioned above (in bold letter). As per dossier of the above product,
received from the PEC, Form-5A and the fresh CoPP submitted by the firm, following position
emerges;
(i) The name and composition of product as per CoPP issued by USFDA is given in
column-V above while that mentioned in the Form-5A is given in column-IV above.
Though both the composition are same, however, the composition in Form-5A also
mentions container-closure system i.e. plastet syringe, the same need to be mentioned
in the registration letter.
(ii) The name of manufacturer as per CoPP and Form-5A is M/s. Zoetis Inc. 2605 East
Kilgore Road Kalamazoo, Michigan, 49001, USA, while in minutes M/s. Pharmacia &
Upjohn Company appears to be incorporated inadvertently and, therefore, require
correction accordingly.
(iii) The shelf life was not mentioned in the minutes, however, as per fresh CoPP submitted
by the firm it is 24 months. Moreover, the finish product specifications for the above
product was approved as manufacturer’s specification, however, in the light decision
made in 264th& 266th meetings of Registration Board, these may be considered as per
innovator specification.
Decision:- Board approved the following corrections in minutes of 260th meeting of
Registration Board with respect to above mentioned product:
a. Name and composition of the product (in accordance with CoPP issued by
US-FDA) is as follow;
“Spectramast DC Sterile Suspension
Each 10ml Plastet Disposable Syringe contains:-
Ceftiofur hydrochloride eq. to 500mg of ceftiofur”
b. Name of manufacturer is corrected from M/s. Pharmacia & Upjohn
Company A Division of Pfizer Inc. Kalamazoo, Michigan, U.S.A to M/s. Zoetis
Inc. 2605 East Kilgore Road Kalamazoo, Michigan, 49001, USA.
c. Shelf life of product (in accordance with CoPP): 24 months.
Case No. 14: REGISTRATION OF DRUGS UNDER THE DRUGS ACT, 1976/ISSUANCE OF
REGISTRATION LETTER.
Registration Board in its 277th meeting approved following imported veterinary drugs.
However, further processing of the registration letter of following product was withheld for the reason
mentioned against each.
Name of Manufacturer/ Name of drug(s) & Composition Approved Decision &
Importer Packs Size Remarks
M/s. Binsadiq International, TAF Oral Solution 25% 80ml Approved as
89-A Canal View Housing (Should be diluted in drinking 1 Litre per Import
Society Lahore. / water before use) 5 Litre Policy for
Manufacturer & Marketing (for broiler chicken and Turkeys) Finished Drugs
Authorization Holder:- Each 100ml of solution contains:- 36 months with innovator’s
M/s. ChemifarmaS.p.A Via Thiamphenicol….. 25mg specifications.
Don Eugenio Servadei 16,
47122 Forli, Italy.
With reference to above mentioned approval following information is submitted:-
(i) The composition as per CoPP is “each ml contains: Thiamphenicol 250mg” while as
per Form-5A it is 25gm per 100ml. The composition in minutes, appears to be wrongly
written as 25mg instead of 25gm apparently due typo error and, therefore need
correction.
(ii) The phrase “(Should be diluted in drinking water before use) & (for broiler chicken and
Turkeys)” may not be mentioned with the brand name in the registration letter for being
instructions.
(iii) The product is on free sale in Italy, therefore the exemption from the inspection can be
considered as per import policy for such drugs. The local storage facility of M/s.
Binsadiq International, Lahore has already been verified by the concerned area FID.
Subsequently the Registration letter was issued to the firm. After getting approval of correction
from Chairman Registration Board.
Decision:- Board approved the following corrections in minutes of 277th Registration Board
meeting with respect to above mentioned product:
“TAF Oral Solution 25%
Each 100ml of solution contains:-
Thiamphenicol….. 25g”
Case No. 15: Request of M/s. Biorific Pharmaceuticals (Pvt) Ltd. Islamabad for Correction of
Pack Sizes.
Registration Board in its 276th meeting approved following locally manufactured veterinary
drug of M/s. Biorific Pharmaceuticals (Pvt) Ltd. Islamabad. However, further processing of the
registration letter of following product was withheld for getting clarification regarding approved pack
sizes.
S.No Name of Name of drug(s) & Composition Approved Remarks
Manufacturer Packs
Sizes
1. M/s. Biorific DOT-C Powder 100ml Approved.
Pharmaceuticals Each 1000g powder contains:- 500ml
(Pvt) Ltd, Plot No. Doxycycline HCl……...400gm 1000ml The pack size mentioned
143, Industrial Tylosine Tartrate………200gm in minutes 100ml, 500ml
Triangle, Kahuta Colistin Sulphate…...1000MIU & 1000ml. While the
Road, Islamabad. Bromhexine HCl.………10gm product is in powder form.
Now after the receipt of duplicate dossier from PEC, the demanded pack sizes by the firm as
mentioned in Form-5 are 100gm, 500gm & 1Kg plastic container. The firm vide a letter has also
claimed specification of the product as innovator.
Decision:- Board approved the following corrections in minutes of 276th Registration Board
meeting with respect to above mentioned product:
Previously Approved Packs Sizes Corrected Pack Sizes
100ml Plastic container of:
500ml 100gm
1000ml 500gm
1kg
Case No.16. Request of M/s. Vet Line International, Lahore for correction of composition.
Registration Board approved the following imported veterinary drugs of M/s. Vet Line
International, Lahore manufactured holder M/s. Bela-Pharm GmbH & Co. KG Lohner Str. 19 49377
Vechta, Germany, in its 236th meeting. The registration letter is not yet issued. Meanwhile the applicant
has requested for correction of composition of their following drug as per detail mentioned below.
S. Product Approved in Composition as per CoPP Approved Remarks/Diar
No. (M-236 Meeting) Pack Size y No. R&I
I II III IV V
1. Pyanosid Powder Pyanosid Powder 146.36gm Dy. No. 15261
146.36g Powder ccontains:- Each gm contains:- 500gm Dated 24-04-
Lincomycin Hydrochloride Lincomycin hydrochloride 1kg 2018.
Monohydrate…39.64gm monohydrate…258.01mg 5kg
SpectinomycinSulpahteTetra equivalent to 227.52mg Lincomycin
hyderate…102.62gm Spectinomycin sulphate tetrahydrate
689.11mg equivalent to 455.73mg
Spectinomycin
M/s. Vet Line International, Lahore has deposited required fee of Rs.5,000/- and submitted
following supporting documents:-
(i) Revised Form-5A
The case was considered in 10th PRVC meeting and it was decided to place the case for
consideration of Registration Board.
Decision:- Board approved the following correction in composition of product Pyanosid
Powder approved in 236th Registration Board meeting:
“Each gm contains:-
Lincomycin hydrochloride monohydrate…258.01mg
(Eq. to 227.52mg Lincomycin)
Spectinomycin sulphate tetrahydrate…689.11mg (Eq. to 455.73mg Spectinomycin)”
Registration-II Section
Case No.17. Concept of “BOXED WARNING” and its Inclusion with Approvals Granted by
The Drugs Registration Board.
A box warning is ordinarily used to highlight for prescribers one of the following situations:
There is an adverse reaction so serious in proportion to the potential benefit from the drug (e.g., a
fatal, life-threatening or permanently disabling adverse reaction) that it is essential that it be
considered in assessing the risks and benefits of using the drug.
OR
There is a serious adverse reaction that can be prevented or reduced in frequency or severity by
appropriate use of the drug (e.g., patient selection, careful monitoring, avoiding certain concomitant
therapy, addition of another drug or managing patients in a specific manner, avoiding use in a specific
clinical situation)
Infrequently, a boxed warning can also be used in other situations to highlight warning information
that is especially important to the prescriber (e.g., reduced effectiveness in certain patient populations).
Information included in the WARNING AND PRECAUTIONS and CONTRAINDICATIONS
sections should therefore be evaluated to determine whether it warrants inclusion in a boxed warning.
Boxed Warnings are most likely to be based on observed serious adverse reactions, but there are
instances when a boxed warning based on an anticipated adverse reaction would be appropriate.
A boxed warning can also be considered for a drug that poses risk- benefit considerations that are
unique among drugs in a drug class (e.g., to note when a drug is the only one in its class to have a
particular risk and is indicated as second line therapy because of that risk).
Information to Provide
The box must contain, in uppercase letters, a heading inside the box that includes the word
"WARNING" and other words that are appropriate to identify the subject of the warning. The heading
and the summary must be contained within a box and bolded. The box must briefly explain the risk/
information that is critical for a prescriber to consider, including any restriction on distribution or use
and refer to more detailed information in the "Contraindications" or "Warnings and Precautions"
section, accompanied by the identifying number for the section or subsection containing the detailed
information
Format
The information in the boxed warning should be in bold print and presented in a bulleted format or
some alternative format, such as the use of subheadings, that helps to make the information visually
accessible.
Sample Formats from USFDA
WARNING: LACTIC ACIDOSIS

Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia,
hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is
often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory
distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized
by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria
or ketonemia), an increased lactate/pyruvate ratio, and metformin plasma levels generally >5
mcg/mL [see Warnings and Precautions (5.1)].
Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of
certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater,
having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute
congestive heart failure), excessive alcohol intake, and hepatic impairment.
Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups
are provided in the full prescribing information [see Dosage and Administration (2.2),
Contraindications (4), Warnings and Precautions (5.1), Drug Interactions (7), and Use in
Specific Populations (8.6, 8.7)].
If metformin-associated lactic acidosis is suspected, immediately discontinue JANUMET and
institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended
[see Warnings and Precautions (5.1)].
WARNING: FETAL TOXICITY

 When pregnancy is detected, discontinue amlodipine and valsartan tablets as soon as possible. (5.1)
 Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing
fetus. (5.1)
Keeping in view the above stated information the case regarding inclusion of boxed warning
(as approved by Reference Regulatory Authorities) with products approved by the Registration Board
is placed for consideration by the Registration Board please.
Decision: Registration Board decided that boxed warning shall conspicuously appear on the
label of all those formulations which have been approved by Reference Regulatory
Authorities with boxed warning. For this purpose, the manufacturer shall adopt
the same format as followed by Reference Regulatory Authorities or innovator
product.
Case No.18. Standard Operating Procedures for approval of post-registration variations..
Registration Board in its 240th meeting held on 07th November, 2013 approved various SOPs
for processing of post registration variations. These SOPs were again considered by the Board in
various meetings (278th, 279th, 281st and 282nd) for further rationalizing the requirements and deferred
for comments of stakeholders. Accordingly, the Board reviewed and approved following SOPs for
further implementation
A. Locally manufactured products:
1. Change in excipients (inactive) including colour.

a) In case of any addition, deletion or substitution of excipient, it shall be sufficient to inform
along with stability data and technical information {b)-g)} in writing for which
acknowledgment shall be obtained for record, as required vide SRO 662(I)/2005 dated 25-06-
2005.
b) Copy of registration letter and last renewal status.
c) Specification of existing and proposed excipients / Colour.
d) Document confirming that proposed excipient / inactive is of pharmaceutical grade.
e) Results of stability testing (as per conditions of zone IV-A ) with a minimum of 3 months of
accelerated and 3 months of long-term testing on 03 lab scale batches or developmental scale
batches as set by Registration Board in 276th meeting. Description and composition of the FPP
including Batch formula, description of manufacturing process and process controls, if different
from previous one.
f) An undertaking that:
i. The provided information is true & correct.
ii. There is no change in specifications of FPP.
iii. All excipients are of Pharmacopeial grade.
iv. All excipients do not include the use of materials of human or animal origin for which
TSE/BSE risk assessment/safety data is required.
v. For any change in the quantity of excipient(s) except for those excipient(s) in which a duty
drawback is claimed, no prior permission shall be required.
vi. That the new excipient does not interfere with the analytical procedures for the FPP.
vii. In case of any quality complaint/ OOS result observed by the marketing authorization holder
as a result of this change, the same shall be reported to Registration Board and all the stock
shall be recalled from the market immediately.
2. Change of Source of Half Finished Products (Pellets / Granules / Ready to Fill Bulk etc)
a) Application with required fee as per relevant SRO.
c) Both real time & accelerated stability studies of Half finished products (pellets / granules / ready
to fill bulk) conducted by manufacturer of half finished product as per conditions of zone IV-A
or zone IV-B on 3 commercial scale batches.
d) Certificate of analysis of manufacturer.
e) Documents confirming that the proposed source has valid permission for manufacturing of
pellets / granules / ready to fill bulk by the regulatory authority of country of origin.
f) Valid & legalized GMP certificate issued by regulatory authority of exporting country if not
already submitted in DRAP during last 1 year.
g) An Undertaking that:
a. Shelf life of finished product would be assigned after conducting product development
studies, real time and accelerated stability studies on 3 batches of commercial scale,
validation of manufacturing process and method of analysis before sale of drug.
b. In case of any quality complaint/ OOS result observed by the marketing authorization
holder as a result of this change, the same shall be reported to registration board and all
the stock shall be recalled from the market immediately.
c. That the provided information is true & correct.
3. Registration of Product from One Manufacturer to another Manufacturer with Change in

Manufacturing Site.
a) Application with Form-5 and required fee as per relevant SRO.
c) Copy of approved section by Central Licensing Board or panel inspection report conducted for
renewal of DML as evidence of approved sections (in cases of DML before 2005).
d) Copy of last inspection report conducted by DRAP within last 12 months.
e) NOC (issued within last 6 Months) from existing manufacturer / registration holder permitting
for registration of product to another manufacturer.
f) Statement / undertaking that applicant do not have registration of same products. If so, it
has to apply for cancellation of product.
g) Undertaking that firm will conduct product development, accelerated and real time stability
studies, validation of manufacturing process and method of analysis before sale of drug.
h) An Undertaking that:
i. Validated method of analysis, master formula and product development data shall be
provided.
ii. In case of any quality complaint/ OOS result observed by the marketing authorization holder
as a result of this change, the same shall be reported to registration board and all the stock
shall be recalled from the market immediately.
iii. Undertaking that the provided information is true & correct.
4. Registration of Product after Change in Name / Title of Manufacturer (Site of Manufacturing
Remains the Same)
a) Application on Form-5 with required fee as per relevant SRO.
c) Approval of new name / title from CLB.
d) Undertaking that:
i. The formulation, API source & Specifications, manufacturing process, release & shelf life
specifications have not changed.
ii. Provided information is true & correct.
5. Extension in Shelf life

a. Application with required fee as per relevant SRO.
b. Copy of registration letter and last renewal status.
c. Proposed shelf-life, justification & data of long-term stability testing (as per conditions of zone
IV-A ) including chromatograms for a minimum of 3 commercial scale batches or development
scale batches as set by Registration Board in 276th meeting up to the proposed shelf-life.
d. An undertaking that:
 No change to the primary packaging type that is in direct contact with the FPP and to the
recommended conditions of storage.
 No change in formulation and specification either of finished product, API and excipients
etc.
 In case both the above conditions are involved then manufacturer will submit complete
requisite information as per procedure.
 In case of any quality complaint/ OOS result observed by the marketing authorization
holder as a result of this change, the same shall be reported to registration board and all
the stock shall be recalled from the market immediately.
6. Reduction in Shelf Life.

a. Application with required fee as per relevant SRO.
b. Copy of registration letter and last renewal status.
c. If proposed shelf-life is for more than two years, justification & data of long-term stability
testing (as per conditions of zone IV-A ) including chromatograms for a minimum of 3
commercial scale batches or development scale batches up to the proposed shelf-life.
d. If the reduction is necessitated because of stability concerns, declaration of reason for reduction
in shelf life.
e. Undertaking that:
a. Provided information is true & correct.
b. The change is not necessitated by failure to meet specifications or resulting from
unexpected events arising during manufacture.
c. In case of any quality complaint/ OOS result observed by the marketing authorization
holder, the same shall be reported to registration board and all the stock shall be recalled
from the market immediately.
7. Change in Labelled Storage Conditions

c) Proposed change is supported by documentary evidence from reference regulatory authorities
and/ or innovator product.
i. The change is in accordance with innovator’s product/ Reference Regulatory Authorities
iii. The change is not necessitated by failure to meet specifications or resulting from unexpected
events arising during manufacture.
iv. If the change is necessitated because of stability concerns, declaration of relevant reason for
change in storage condition.
v. In case of any quality complaint/ OOS result observed by the marketing authorization holder,
the same shall be reported to registration board and all the stock shall be recalled from the
market immediately.
8. Change in Prescribing Information (PI)

c) Difference between existing and proposed information in tabulated form.
d) Justification of proposed changes.
e) Reference of prescribing information approved by Reference Regulatory Authorities and
innovator product.
f) Copy of approval from regulatory agency / authority from country of origin for innovator’s
product
g) Copy of label outer pack in case of changes in indication/ dose/ administration etc.
h) Undertaking that the provided information is true & correct.
9. Change in Primary Packaging Material/ Container Closure System.
c) Justification of proposed change including data on the suitability of the container-closure
system (e.g. extractable/ leachable testing (where applicable), permeation testing, light
transmission) demonstrating equivalent or superior protection compared to the current
packaging system. For changes to functional packaging related to container closure (e.g MDIs
etc), data to demonstrate the functioning of the new packaging.
d) If the container closure system of applied formulation is different from that of the reference
product, manufacturer will place first three lab scale batches or developmental scale batches as
set by Registration Board in 276th meeting, at 3 months of accelerated and 3months of real time
studies for compatibility of applied formulation with container closure system as directed by
Pharmacopeia of Reference Regulatory Authorities. Registration Board shall be informed
immediately and along with market withdrawal in case of any significant change about result
of stability studies.
e) Shelf life of the drug product supported with justification.
f) Existing and proposed container closure system with differences (e.g. description, materials of
construction of primary packaging components, specifications, if appropriate) highlighted in
tabular form.
g) If the proposed change requires change in manufacturing section/ facility, then a new registration
application with prescribed fee shall be submitted.
h) Undertaking:
i. To perform stress studies.
ii. In case of any quality complaint/ OOS result observed by the marketing authorization
holder as a result of this change, the same shall be reported to registration board and all the
stock shall be recalled from the market immediately.
iii. Provided information is true & correct.
10. Change in the Shape or Dimensions of the Container Closure System

c) Information on the proposed container-closure system (e.g. description, materials of
construction, and specifications).
i. Other specifications of the product would remain the same.
ii. There is no change in the qualitative & quantitative composition of the product and
manufacturer will conduct product development, accelerated and real time stability studies,
iii. In the case of changes to the thickness of a packaging component or for sterile FPPs:
stability data (as per conditions of zone IV-A ), where applicable, results of photo-stability
studies shall be conducted on 03 lab scale batches or developmental scale batches as set by
Registration Board in 276th meeting.
iv. In the case of a change in the headspace or a change in the surface/volume ratio for non-
sterile FPPs, a commitment for the above studies to ensure appropriate delivery.
v. Revalidation studies shall be conducted in the case of terminally sterilized products. The
batch numbers of the batches used in the revalidation studies should be indicated, where
applicable.
vi. No change in the qualitative or quantitative composition of the container and/or Closure.
vii. The change does not concern a fundamental part of the packaging material, which could
affect the delivery, use, safety or stability of the FPP.
viii. In case of any quality complaint/ OOS result observed by the marketing authorization
ix. Undertaking that the provided information/ documents are true/ correct.
11. Change of Secondary Packaging Materials.

c) Justification of proposed change.
d) Existing and proposed packaging materials.
e) Difference between existing and proposed information in tabulated form.
f) Confirmation and undertaking that proposed label complies all provisions of Drugs
(Labeling & Packing) Rules,1986.
g) An undertaking that:
a. 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.
b. Dosage, administration, indication & direction for use etc. on the label be in line with
marketing authorization.
12. Registration of Drugs (for Export Purpose).

a) Application on Form 5/Form 5D/ form5F (CTD) with required fee as per relevant SRO.
b) Copy of approved section from CLB or Panel Inspection Report for Renewal of DML as
evidence of approved sections for DML before 2005.
c) Copy of last inspection report conducted by DRAP within last 12 months.
d) An undertaking that applied registration is exclusively for export purpose and will not
be sold in Pakistan.
e) Evidence of generic / approval status by Reference Regulatory Authorities for applied
formulation. In cases where the formulations are neither generic nor approved by Reference
Regulatory Authorities, applicant will provide evidence of approval status of applied
formulation by regulatory authority of importing country.
f) Copy of DML along with its renewal status.
g) An undertaking that the proposed names/ label/ color do not resemble with already registered
brands in importing country. In case of resemblance/similarity with already registered drug
product in importing country, the applicant will be liable to change immediately.
13. 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).
c) Justification for proposed change.
d) Information regarding previous change of brand name since registration of drug.
e) Details (batch number, date of manufacture, quantity and stock position) regarding last batch
manufactured.
f) 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.
g) Undertaking that provided information/ documents are correct.
h) For reports regarding brand name resemblance, following documents/ information will be
required:
i. Copy of registration letter & last renewal status of their registered product.
ii. Unit carton/ any other information as evidence of resemblance which is being reported.
iii. Undertaking that the provided information/ documents are true/ correct.
14. Change in Shape of Tablet / Color and Size of Capsule.

i. Other specification of the product would remain the same.
ii. There is no change in the qualitative & quantitative composition of the product and
manufacturer will conduct product development, accelerated and real time stability studies,
iii. In case of any quality complaint/ OOS result observed by the marketing authorization
iv. Undertaking that the provided information/ documents are true/ correct.
15. Cancellation of Registration of Drug on Firm’s Request.
a) Application.
c) Justification
d) List of alternatives brands/ FPPs available in the country.
e) An undertaking that:
i. No case is pending at any forum / court of law regarding this product.
ii. Provided information/ documents are true/ correct.
16. Corrigendum for Correction in Registration Letter.
a) Application with required fee as per relevant SRO, if error is on part of firm.
c) Document in support of proposed correction.
d) Undertaking that the provided information/ documents are true/ correct.
17. Standardization of Formulation In Accordance With the Innovator’s Product/ Reference

Regulatory Authorities and Pharmacopeias.
c) Document in support of proposed correction/evidence of approval status by Reference
Regulatory Authorities/ innovator product and/ or Pharmacopeias as adopted by Registration
Board.
d) Undertaking that the provided information/ documents are true/ correct.
18. Change of Finished Product Specifications

c) Document in support of proposed change.
d) Analytical reports as per monograph of FPP.
e) Undertaking that :
i. The change is made exclusively to comply with the pharmacopeia of Reference Regulatory
Authorities or as per Innovator’s product specifications.
ii. No case is pending at any forum / court of law regarding this product.
iii. In case of any quality complaint/ OOS result observed by the marketing authorization
iv. The provided information/ documents are true/ correct.
19. Grant of Additional Pack Size for Locally Manufactured Veterinary Products (Excluding
Injectables)
c) Detail of previously granted pack sizes.
d) Generic status/ evidence of availability of applied additional pack sizes.
e) Undertaking that the provided information/ documents are true/ correct.
f) GMP inspection conducted by DRAP during last 12 months.
B. Imported products:
1. Change of Name of Manufacturer/ Marketing Authorization Holder of Imported Drugs.

c) 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 Or any legalized document
of concerned regulatory authority confirming change of name of Manufacturer/ Marketing
Authorization Holder without change in manufacturing site
d) Revised Sole Agency Agreement when there is change in MAH.
e) Proof/ evidence of the contract between Product License Holder & manufacturer (with changed/
new name), where the manufacturer and product license holder are different entities.
f) Undertaking that the provided information/ documents are true/ correct.
2. Change of Address of Manufacturing Site/Source/Marketing Authorization Holder (MAH).
a) Application on Form 5A with required fee as per relevant SRO.
c) 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.
d) Site master file of new manufacturing site in case of change of manufacturing site/ source.
e) Revised Sole Agency Agreement when there is change in MAH.
f) Proof/ evidence of the contract between Product License Holder & manufacturer (with changed/
new name), where the manufacturer and product license holder are different entities.
g) Undertaking that the provided information/ documents are true/ correct.
3. Change in Shelf Life.
c) Proposed shelf-life, justification & data of long-term stability testing (as per conditions of zone
IV-A) including chromatograms for a minimum of 3 commercial scale batches or development
scale batches upto the proposed shelf-life.
d) Approval of regulatory body of country of origin or Original and legalized Certificate of
Pharmaceutical Product as per WHO format.
e) Undertaking that:
i. Provided information is true & correct.
ii. For reduction in shelf life:
 The change is not necessitated by failure to meet specifications or resulting from
unexpected events arising during manufacture.
 If the reduction is necessitated because of stability concerns, declaration of reason for
reduction in shelf life.
iii. For extension in shelf life:
 No change to the primary packaging type in direct contact with the FPP and to the
recommended conditions of storage.
 No change in formulation and specification either of finished product, API and
excipients etc.
 In case both the above conditions are involved then manufacturer will submit complete
requisite information as per procedure.
4. Change in Labelled Storage Conditions

c) Undertaking that:
i. The change is in accordance with innovator’s product/ Reference Regulatory Authorities
iii. The change is not necessitated by failure to meet specifications or resulting from unexpected
events arising during manufacture.
iv. If the change is necessitated because of stability concerns, declaration of reason for change
in storage condition.
5. Registration of Product from One importer to another Importer.

c) Termination letter (original) from manufacturer for previous importer.
d) Authority letter/sole agent letter (original) from manufacturer.
e) Document confirming NOC (issued within last 6 Months) from existing registration holder
permitting for registration of product to another importer.
f) 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.
6. Change in Primary Packaging Material/ Container Closure System

b) Copy of registration letter and renewal status.
c) Justification of proposed change including data on the suitability of the container-closure
system (e.g. extractable/ leachable testing (where applicable), permeation testing, light
transmission) demonstrating equivalent or superior protection compared to the current
packaging system. For changes to functional packaging related to container closure (e.g MDIs
etc), data to demonstrate the functioning of the new packaging.
d) If the container closure system of applied formulation is different from that of the reference
product, manufacturer will place first three commercial scale batches at 3 months of accelerated
and 3months of real time studies for compatibility of applied formulation with container closure
system as directed by Pharmacopeia of Reference Regulatory Authorities. Registration Board
shall be informed immediately and along with market withdrawal in case of any significant
change about result of stability studies.
e) Shelf life of the drug product supported with justification.
f) Existing and proposed container closure system with differences (e.g. description, materials of
construction of primary packaging components, specifications, if appropriate) highlighted in
tabular form.
g) Undertaking
 To perform stress studies.
 That the provided information is true & correct.
7. Change in Secondary Packaging Materials.

b) Copy of registration letter and renewal status.
c) Justification of proposed change.
d) Existing and proposed packaging materials.
e) Difference between existing and proposed information in tabulated form.
f) Confirmation and undertaking that proposed label complies all provisions of Drugs
(Labeling & Packing) Rules,1986.
g) 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.
h) Dosage, administration, indication & direction for use etc. on the label be in line with that
authorization.
i) Regulatory approval of change from country of export.
j) Undertaking that the provided information/ documents are true/ correct.
8. 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).
d) Information regarding previous change of brand name since registration of drug.
e) Details (batch number, date of manufacture, quantity and stock position) regarding last batch
imported.
f) 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.
g) 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.
h) Undertaking that the provided information/ documents are true/ correct.
9. Change in Name of Importer of Drug Product with No Change of Proprietor.

c) Copy of Drug Sale License with new name.
d) Approval of new name by SECP / registrar of firm.
e) Sole Agency agreement with new name of importer by Manufacturer or product License
Holder.
f) Undertaking by the firm that no case is pending at any forum / court of law regarding previous
name.
10. Grant of Additional pack size for Veterinary Products Excluding Injectables
c) Detail of previously granted pack sizes.
d) Evidence of availability of demanded pack size in country of origin.
e) Undertaking that the provided information/ documents are true/ correct.
C. Correction/Changes That Necessitate Submission of New Application (Local

Manufacture/Import):
a) Change in the dose and/or strength of one or more APIs.
b) Change from an immediate release product to an extended or delayed-release dosage form or
vice versa.
c) Change in dosage form.
d) Case of additional flavor.
e) Change of the API to a different API.
f) Inclusion of an additional API in a multicomponent product.
g) Removal of one API from a multicomponent product.
(Note: Standardization of formulation in accordance with the standard formulation as approved

by Reference Regulatory Authorities or innovator product will be done along with
post registration variation)
Case No. 19: Approved Product of M/s Helix Pharma (Pvt) Ltd. Karachi.
Following Product of M/s Helix Pharma (Pvt) Ltd. Karachi was approved vide 235th
meeting of Registration Board as per details below:
S.No. Name of Drug(s) with Demanded Demanded Decision
composition Pack Price
1. Sitaglip Tablet 100mg 28’s Rs.4571.41 Approved Subject to
Each Tablet contains: submission of signed
Sitagliptin as undertaking
Phosphate…..100mg
(Anti hyperglycaemic)
The firm has now submitted duplicate application on Form-5D along with undertaking
regarding proposed brand name and photocopies for submission of balance fee of Rs.5000/- and initial
fee of Rs.15,000/- and requested for issuance of registration letter.
Furthermore, as per form-5D submitted by the firm, formulation is film coated tablet.
Decision: Registration Board approved the grant of registration for Sitaglip Tablet 100mg with
USP specifications.
Case No.20. Approved Product of M/s Hilton Pharma (Pvt) Ltd. Karachi
Following Product of M/s Hilton Pharma (Pvt) Ltd. Karachi were approved vide 235th
meeting of Registration Board as per details below:
S.No. Name of Drug(s) with composition Demanded Demanded Decision
Pack Price
1. Talimus 0.5mg Capsule 10’s As per PRC Approved
Each capsule contains: 30’s
Tacrolimus Monohydrate eq. to
Tacrolimus Anhydrous….0.5mg
(Macrolide Immunosuppressant)
2. Talimus 1mg Capsule 10’s As per PRC Approved
Tacrolimus Anhydrous….1mg
3. Talimus 5mg Capsule 10’s As per PRC Approved
Tacrolimus Anhydrous….5mg
The firm has now submitted revised Form-5 along with balance fee of Rs.12000/-each and
requested for issuance of registration letter.
Decision: Registration Board approved the grant of registration for products at S.No.1-3 of
above mentioned table with USP specifications. The Board further directed that the
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.
Case No.21. Approved Product of M/s PharmEvo (Pvt) Ltd. Karachi

Following Product of M/ s PharmEvo (Pvt) Ltd. Karachi were approved as new
molecule vide 227th meeting of Registration Board as per details below:
S.No. Name of Drug(s) with Demanded Demanded Decision
composition Pack Price
1. ENMO Tablet 14’s Rs.8000.00 Approved
Each tablet contains: 30’s Rs.17150/-
Carbidopa….25mg
Levodopa….100mg
Entacapone…..200mg
(Anti Parkinson)
2. ENMO Tablet 14’s Rs.10500/- Approved
Each tablet contains: 30’s Rs.22500/-
Carbidopa….50mg
Levodopa….200mg
Entacapone…..200mg
(Anti Parkinson)
The firm has now submitted photocopies for submission of balance fee of Rs.5000/- and initial
fee of Rs.15,000/- and requested for issuance of registration letter.
Decision: Registration Board approved the grant of registration for products at S.No.1-2 of
above mentioned table with specifications “As per Innovator’s”.
Case No.22. Status of Product of M/s Helix Pharma (Pvt) Ltd. Karachi
Following Product of M/ s Helix Pharma (Pvt) Ltd. Karachi were considered vide 267th meeting
of Registration Board. Minutes of 267th Registration are reproduced as below;
“Deferred Products of M/s Helix Pharma, Karachi in 236th meeting of Registration Board.
Registration Board in its 236th meeting deferred the products of M/s Helix Pharma, Karachi for
the reasons given in the last column below:
S.No. Name of drug(s) & Composition Pack Size Decision
1. Pagabin Capsules 75mg 14’s Referred to the
Each capsule contains:- committee
Pregabalin………...75mg
(Anticonvulsants)
Pregabalin……….150mg
(Anticonvulsants)
Pregabalin……….300mg
(Anticonvulsants)
Now the firm has submitted for reconsideration of the case and deposited the differential fee of Rs.
12,000/- for each endorsed by STO DRAP on 13th December, 2016.
Decision: Registration approved grant of registration of aforementioned products at S.No. for
M/s Helix Pharma, Karachi.”
Registration letters for product at Sr.No 01-02 have already been issued. While processing for
issuance of registration letter for the product at Sr.No 03 it was observed that serial numbers of
approved products have not been specified in the decision of M-267.
Decision: Keeping in view the registration status of products at S.No. 1-2, Registration Board
approved the grant of registration for product at S.No.3 of above mentioned table.
Case No.23. Approved Product of M/s Pharmatec Pakistan (Pvt) Ltd. Karachi
Following product of M/ s Pharmatec Pakistan (Pvt) Ltd. Karachi were approved vide
nd
262 meeting of Registration Board as per details below:
S.No. Brand name (Proprietary Type of form Initial Remarks on the formulation (if any Decision
Name +Dosage Form+ Date, Diary Fee, including intenational status in
Strength )Composition including Differential stringent DRA ,me too status,GMP
,Pharmacological Group, Fee, Demanded Price, status as depicted in the latest
Finished Product Pack size inspection report(with date)by the
Specification Evaluator
1. Levefil XR 1000mg Tabet Form5 Keppra XR by UCB group of Approved
Each film coated tablet 14-05-2014 companies (USA),
contains: Dy.No.727 Keppra of UCB Pharma
Levetiracetam Routine
USP….1000mg Rs.20,000/- Inspection report dated
Pyrrolidone derivative. 10’s/As per PRC 23-10-2013 showing compliance of
(Manufacturers Specs) GMP as Good”.
The case was referred to Pharmaceuticals Evaluation Cell for confirmation of dosage form and
description of the product as the brand name of above product mentioned “XR” as dosage form of the
drug whereas Pharmaceutical form/ description of the product was presented as “film coated tablet”.
PEC later on confirmed that the firm has applied for “Film coated XR tablet”. Furthermore, MRP has
also been fixed for the above mentioned formulation, vide S.R.O 252(I)/2018. However, approval
status of “Levetiracetam XR 1000mg Tablet” could not be verified in Reference Regulatory
Authorities.
The firm has now submitted revised form-5 for registration of “Levetiracetam 1000mg Film
coated Tablet” i.e., approved by USFDA and requested for issuance of registration letter.
Decision: Registration Board deferred the case for submission of fresh fee of Rs.20,000/-.
Case No.24. Change of Registration Status From One Manufacturer To Another Manufacturer
In 271st meeting of Registration Board, M/s GlaxoSmithKline Pakistan, Korangi Site DML
000248 Karachi applied for the registration of various products in their name form M/s
GlaxoSmithKline Pakistan DML No.000017. However, following two products were deferred for
confirmation of approval status from Reference Regulatory Authorities.
S.No. Reg. No Name of drug(s) Initial
Registration
1. 000248 Betnesol Eye, Ear and Nose Transfer dated 29.08.2003
Drops
2. 000250 Betnesol N Drop Transfer dated 29.08.2003
The firm has now provided documents confirming approval status in MHRA. Complete
composition of above mentioned products taken from National Formulary 1981 and products approved
by UK MHRA is mentioned below:
S.No. Reg. No Name of drug(s) Composition Approval Status
1. 000248 Betnesol Eye, Ear Betamethasone UK MHRA approved Betnesol Eye, Ear
and Nose Drops disodium phosphate in and Nose Drops Solution 0.1% w/v
sterile isotonic buffered
solution 0.1%
2. 000250 Betnesol N Drop Betamethasone UK MHRA approved Betnesol-N Eye,
disodium phosphate Ear and Nose Drops containing
0.1% Betamethasone sodium phosphate
Neomycin sulphate PhEur….0.105%w/v
0.5% (equivalent to 0.1% w/v betamethasone)
Neomycin sulphate PhEur …0.5% w/v
(equivalent to 0.385% w/v neomycin
base)
Decision: The Registration Board approved the change in registration status of above
mentioned products at S.No. 1-2 from the name of M/s GlaxoSmithKline Pakistan,
DML No.000017 to the name of M/s GlaxoSmithKline Pakistan, Korangi Site, DML
No.000248 Karachi.
Registration-III Section
Case No.25: Change in Specifications:
M/s Innvotek Pharmaceuticals, 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 on Desired Change in label claim &
Initial Registration Letter Specifications
1. 075284 Olotek 0.1% Eye Drops Olotek 0.1% Eye Drops
Each ml contains: Each ml contains:
Olopatadine hydrochloride eq. to Olopatadine hydrochloride eq. to
Olopatadine …..1mg (0.1%w/v) Olopatadine …..1mg (0.1%w/v)
(Innvotek’s Specifications) (USP Specifications)
2. 075285 Olotek-DS 0.2% Eye Drops Olotek-DS 0.2% Eye Drops
Olopatadine hydrochloride eq. to Olopatadine hydrochloride eq. to
Olopatadine …..2mg (0.2%w/v) Olopatadine …..2mg (0.2%w/v)
3. 072851 Inmox Eye Drops Inmox Eye Drops
Moxifloxacin as hydrochloride …..5mg Moxifloxacin as hydrochloride …..5mg
(0.5%w/v) (0.5%w/v)
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 SRO. If Fee of Rs.5000/- for each product has been deposited.
error is on part of firm.
Copy of registration letter and renewal status. For products at S. No. 1 & 2:
Initial Registration: 03-04-2013
Renewal due: 02-04-2018
Renewal Applied: 28-03-2018
For product at S. No. 3:
Initial Registration: 19-08-2011
Renewal due: 18-08-2016
Renewal Applied: 19-09-2016 (Rs.20,000/-)
(Late within 60 days with double fee. Verification of
renewal status is required.)
NOC for CRF clearance. Copy of CRF (valid up to 31-12-2018)
Documents in support of proposed correction Copy of USP monographs of above products.
Now, the firm has requested for change in finished product specifications of products mentioned
above form Innvotek’s Specifications to “USP Specifications”.
Decision: Registration Board decided as follows:
i) Approved the change in finished product specifications of products at S. No. 1 & 2 from
Innvotek’s Specifications to USP Specifications.
ii) Deferred the request of the firm for product at S. No. 3 for verification of renewal status
of product.
Case No.26: Change in Contract Manufacturer:
M/s. Ambrosia Pharmaceuticals, Islamabad have requested for change in contract
manufacturer from M/s Wise Pharmaceuticals, Rawat to M/s Webros Pharmaceuticals, Rawat for the
following registered products. Their previous approval was granted by the Registration Board in its
250th meeting till 30.06.2020 as per detailed below:-
S. Name of Existing New Reg. Name of drug(s) & Date of Validity of
No Applicant Manufactu Manufactur No. Composition application permission
. rer er , Diary No.
& Form
1. M/s. M/s Wise M/s Webros 060954 Maxgard Dry 100mg 26-04-2018 30-06-2020
Ambrosia Pharmaceuti Pharmaceuti Suspension Dy.No.1562 F.8-4/2015-
Pharmaceu cals, Rawat- cals, Rawat- Each 5ml contains:- 6 Reg-III (M-
ticals, Islamabad Islamabad Cefixime (as Rs.50,000/= 250)
Islamabad Trihydrate)…..100mg
2. -do- -do- -do- 060955 Maxgard Dry 200mg 26-04-2018 30-06-2020
Suspension Dy.No.1562 F.8-4/2015-
Each 5ml contains:- 7 Reg-III (M-
Cefixime (as Rs.50,000/= 250)
Trihydrate)….200mg
3. -do- -do- -do- 060956 Maxgard 400mg 26-04-2018 30-06-2020
Capsule Dy.No.1562 F.8-8/2015-
Each capsule contains:- 8 Reg-III
Cefixime (as Rs.50,000/= (M-254)
Trihydrate)….400mg
Firm has submitted following documents in this regard:
a) Application/Form 5 along with fee of Rs.50,000/- for each product.

b) Copy of contract manufacturing agreement between M/s. Ambrosia Pharmaceuticals,
Islamabad and M/s Webros Pharmaceuticals, Rawat-Islamabad dated 11.07.2017.
c) Panel GMP inspection report of M/s Webros Pharmaceuticals, Rawat-Islamabad (dated 12-06-
2017) concluding that firm is found to be complying GMP standards.
d) DML of both contract giver (08-12-2014) and acceptor (10-04-2014).
e) Approval of Cephalosporin (Capsule and Dry Powder for Suspension) section evident from
panel inspection report for renewal of DML dated 15-01-2015 (M/s Webros Pharmaceuticals,
Rawat-Islamabad).
Registration Board considered the case in its 282nd meeting and decided as follows:
Decision of 282nd meeting of Registration Board:
Registration Board deferred the request of firm for justification of proposed change.
Now the firm has submitted the copy of notice for discontinuation of contract manufacturing
served to them by M/s Wise Pharmaceuticals dated 14-09-2017. M/s Wise Pharmaceuticals served
three months’ notice because of their own production load.
Decision: Registration Board acceded to the request of M/s. Ambrosia Pharmaceuticals,
Islamabad for change in contract manufacturer from M/s Wise Pharmaceuticals,
Rawat-Islamabad to M/s Webros Pharmaceuticals, Rawat-Islamabad. Permission
is at same terms and conditions and remains valid till 30.06.2020.
Case No.27: Registration of Product of M/s Tas Pharmaceuticals Deferred in 224th Meeting of
Registration Board:
Registration Board in its 224th meeting held on 21st & 22nd April, 2010 deferred the
following dossier of registration of M/s TAS Pharmaceuticals, Islamabad for manufacturing on contract
basis till the finalization of contract policy:-
S. Name of Firm Name of drug(s) & Dema Dema Date of Decision of
# Composition nded nded application Registration
Pack price Board taken in
its 224th
meeting
1. M/s. TAS Tasocefix 200 mg Dry 30ml As Per 15-4-2009 Deferred till the
Pharmaceuticals, Suspension SRO finalization of
Islamabad. Each 5ml contains: contract policy.
contract Cefixime…..200mg
manufactured (Cephalosporin)
by M/s. Biorex
Pharmaceuticals,
Islamabad
Now the firm has requested to change the name of the product from “Tasocefix Dry
Suspension” to “Tasocef Dry Suspension” and manufacturing site/unit from M/s. Biorex
Pharmaceuticals, Islamabad to M/s. Bio-Lab (Pvt) Ltd., Islamabad.
Evaluation of case:
The dossier has been evaluated as per check list approved in 251st meeting of Registration Board.
Following documents are submitted by the firm:
 Form 5 along with fee Rs.8,000/. dated 09-04-2009 and Rs.42,000/- dated 17-03-2016.
 Copy of contract manufacturing agreement between M/s Tas Pharmaceuticals (Pvt) Ltd.,
Islamabad and M/s. Bio-Lab (Pvt) Ltd., Islamabad dated 23-01-2015.
 Evidence of Section approval (Dry Powder Suspension Cephalosporin) of M/s. Bio-Lab (Pvt)
Ltd., Islamabad granted by CLB dated 22-10-2008.
 Latest GMP inspection report of M/s. Bio-Labs, Islamabad (Dated 05-12-2017) with conclusive
remarks of “The panel unanimously recommends for the issuance of GMP certificate”.
 Latest inspection report of M/s. Tas Pharmaceuticals, Islamabad (Dated 29-03-2017) shows that
premises was under renovation. Firm has applied for renewal of DML in November 2015.
Registration Board considered the case in its 275th meeting and decided as follows:
Decision of 275th meeting of Registration Board:
Registration Board deferred the case for updated status of GMP of M/s Tas Pharma, Islamabad.
Now the firm has submitted latest panel inspection report for renewal of DML No. 000375
(formulation) and grant of additional sections dated 27-04-2018 concluding that:
“Panel unanimously decided to recommend the renewal of DML no. 000375 by way of
formulation with restoration of production (which was held by the firm due to upgradation) and grant
of additional/amended sections.”
M/s Tas Pharmaceuticals (Pvt) Ltd., Islamabad has four sections confirmed from inspection
report for renewal of DML dated 27-04-2018 and there are 5 products already registered in their name
for contract manufacturing.
Decision: Registration Board deferred the case for assessment and confirmation of
manufacturing capacity of M/s Bio-labs by panel to be constituted by Chairman
Registration Board for further granting contract manufacturing permission as the
firm has already been granted approval for contract manufacturing of numerous
products.
Case No. 28: Corrigendum in letter for approval of change of brand name.
M/s Ambrosia Pharmaceuticals, Islamabad have requested for change / correction of

dosage form / formulation in letter for change of brand name (letter No. F.1-6/2011-Reg-III dated 04-
7-2017) of following products as mentioned below:
Sr. Reg. Existing Brand Name of Drug (s) with Desired Correction
No. No. composition
I II III IV
1. 060102 Amrotose-FA Tablets Amrotose-FA Tablets
Each tablet contains: Each chewable tablet contains:
Iron (elemental) as hydroxide Iron (elemental) as hydroxide polymaltose
polymaltose………….100mg complex………….100mg
Folic Acid ……………0.35mg Folic Acid ……………0.35mg
(As per Innovator’s Specifications) (As per Innovator’s Specifications)
2. 069974 Amrotose Tablets 100mg Amrotose Tablets 100mg
Each chewable tablet contains: Each chewable tablet contains:
Iron (elemental) as hydroxy Polymaltose Iron (elemental) as hydroxide Polymaltose
complex……….100mg complex……….100mg
(As per Innovator’s Specifications) (As per Innovator’s Specifications)
3. 068631 Inflam Tablet 400mg Inflam Tablet 400mg
Each tablet contains: Each film coated tablet contains:
Ibuprofen….400mg Ibuprofen….400mg
(BP Specifications) (BP Specifications)
Firm has not submitted fee for above correction. They have submitted that at the time change
of brand name we have submitted Rs.20,000/- the same fee may kindly be considered for such
corrections.
Decision of Chairman RB in 4th meeting of PRVC:
The Committee evaluated the case in the light of SOPs approved by the Registration Board.
Chairman Registration Board, upon recommendation(s) of Committee decided to defer the request of
M/s Ambrosia Pharmaceuticals, Islamabad for consideration of Registration Board.
The Registration Board considered the case in its 279th meeting and decided as follows:
Decision of Registration Board in 279th meeting:
Registration Board deferred the request of the firm for submission of fee for such corrections.
Now the firm has submitted fee of Rs. 5000/- per product for above mentioned corrections.
 Acceded to the request of the firm for S.No.2 and 3.
 Deferred S.no.01 for verification from record.
Case No.29: Drug Manufacturing Licenses cancelled by CLB.
Central Licensing Board in its various meetings cancelled Drug Manufacturing Licenses
(DMLs) of following firms as per details mentioned below:-
Sr. No. Name of Firms DML No. & CLB Meeting
Type No.
1. M/s Florence Farmaceutics (Pvt.) 000635 261st held on 2nd
Ltd., Plot No. 266, Industrial (Formulation) May, 2018
Triangle, Kahuta Road, Islamabad
2. M/s. Genera Pharmaceuticals, Plot 000448 259th held on 29th-
No. 244, Street No. 8, I-9/2, (Formulation) 30th March,2018
Industrial Area, Islamabad
The case is submitted for consideration of Registration Board with regard to status of drugs registered with these
firms after cancellation of their DMLs.
Decision: Keeping in view the decision of Central Licensing Board for cancellation of Drug
Manufacturing License the Registration Board deliberated and cancelled the registration
of all drug products registered in the name of above firms.
Case No. 30: Registration of Drugs on Contract manufacturing basis:

M/s Paramount Pharmaceuticals, Islamabad have applied for registration of
following drugs on contract basis from M/s Caraway Pharmaceuticals, Islamabad. The case was
initially considered in 241st meeting of Registration Board under caption of export registration and the
Board decided as follows:
Decision of 241st meeting of RB:
Concerned registration section informed that following applications are erroneously mentioned
as export registrations. These applications are for local sale. Registration Board deferred these
applications for re-check by registration section.
Now the application dossiers have been checked and found that firm has applied for registration
of drugs on contract basis for local market/sale. The detail of the drugs is as under:
S. Name of Name of Name of Drug with Composition Price & Date &
No. Applicant Manufacturer Proposed Diary # &
Pack Size Fee
1. M/s Paramount M/s Caraway Paramin 500mcg Injection As Per SRO 20-02-2013
Pharmaceuticals, Pharmaceuticals, Each ampoule (1ml) contains:- Dy.No.1159
Islamabad. Rawat. Mecobalamin…….500mcg 1’s Fee
(Manufacturer’s Specs) ampoule Rs.20,000/=
2. -do- -do- Para-Rose Injection As Per SRO 20-02-2013
Each ampoule (5ml) contains:- Dy.No.1163
Iron as Iron Sucrose …100mg 1’s Fee
(USP Specifications) ampoule Rs.20,000/=
3. -do- -do- Parapime 500mg Injection As Per SRO 20-02-2013
Each vial contains:- Dy.No.1155
Cefipime HCl………500mg 1’s Fee
(USP Specifications) vial Rs.20,000/=
4. -do- -do- Parapime 1gm Injection As Per SRO 20-02-2013
Cefipime HCl………1gm 1’s Fee
(USP Specifications) vial Rs.20,000/=
5. -do- -do- Paratactum 1gm Injection As Per SRO 20-02-2013
Cefoperazone (as 1’s Fee
Sodium)……….500mg vial Rs.20,000/=
Sulbactam (as
Sodium)………..500mg
(Caraway’s Specs)
6. -do- -do- Paratactum 2gm Injection As Per SRO 20-02-2013
Cefoperazone (as 1’s Fee
Sodium)……….1000mg vial Rs.20,000/=
Sulbactam (as
Sodium)………..1000mg
(Caraway’s Specs)
7. -do- -do- Para-On 250mg Injection As Per SRO 20-02-2013
Ceftriaxone Sodium eq. to 1’s Fee
Ceftriaxone ……….250mg vial Rs.20,000/=
(USP Specifications)
8. -do- -do- Para-On 500mg Injection As Per SRO 20-02-2013
Ceftriaxone ……….500mg vial Rs.20,000/=
9. -do- -do- Para-On 1gm Injection As Per SRO 20-02-2013

Ceftriaxone ……….1gm vial Rs.20,000/=
Firm has submitted following documents in this regard:
a) Application/Form 5 along with differential fee of Rs.30,000/- for each product dated 20-04-
2017.
b) Copy of contract manufacturing agreement between M/s. Paramount Pharmaceuticals,
Islamabad and M/s Caraway Pharmaceuticals, Islamabad dated 18.02.2013.
c) NOC from M/s Caraway Pharmaceuticals, Islamabad.
d) Latest GMP inspection report of M/s Caraway Pharmaceuticals, Islamabad (dated 19-12-2017)
concluding that overall GMP compliance is GOOD.
e) DML of both contract giver (04-10-2014) and acceptor (19-06-2013).
f) Approval of Dry Powder Injection (Cephalosporin) and Liquid ampoule (Injectable) sections
(M/s Caraway Pharmaceuticals, Islamabad).
M/s Paramount possesses six (06) sections and no product is registered in their name for contract.
Decision: Registration Board approved the above products in the name of M/s Paramount
Pharmaceuticals, Islamabad on contract basis from M/s Caraway
Pharmaceuticals, Islamabad.
Case No. 31: Export Registration:

M/s. Vision Pharmaceuticals, Islamabad has requested for grant of registration of
following drugs for export purpose only. The details are as under:-
S. Name of drug(s) & Fee 1)International Revised composition
No. Composition R&I date Availability / Mee-
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. Visosol-R IV infusion 1) Fees Rs.20,000/- GMP inspection dated Visosol-R IV infusion
1000ml 2) Form 5 26-01-2018 1000ml
Each 100ml contains: concluding that firm Each 1000ml contains:
Dextrose monohydrate 3) NOC for CRF was considered to be Dextrose ……….50g
………….5g submitted up to operating at GOOD Sodium chloride ….5.26mg
Sodium chloride 31-12-2017 level of GMP Potassium chloride
….573mg compliance. ….…0.38mg
Sodium acetate Large volume Magnesium chloride
anhydrous ..…..346mg Parenterals section Undertaking …..0.29mg
Potassium acetate approved regarding export Sodium acetate trihydrate
….…49mg purpose provided ……6.81mg
Magnesium acetate Water for
tetrahydrate…..32.2mg injection(QS)….1000ml
Sodium metabisulfite Which contains m moles
……30mg equivalent of:
Na+ ………140mmol
K+ ………..5mmol
MG++ ………3mmol
Cl- ………..98mmol
Acetate…….. 50mmol
5% Dextrose
2. Visosol-R 7.4 IV 1) Fees Rs.20,000/- GMP inspection dated Visosol-R 7.4 IV infusion
infusion 1000ml 2) Form 5 26-01-2018 1000ml
Each 100ml contains: concluding that firm Each 1000ml contains:
Sodium chloride 3) NOC for CRF was considered to be Sodium chloride ….5.26mg
….526mg submitted up to operating at GOOD Potassium chloride
Sodium 31-12-2017 level of GMP ….…0.38mg
acetate..…..222mg compliance. Magnesium chloride
Sodium …..0.29mg
gluconate…….502mg Undertaking Sodium acetate trihydrate
Potassium chloride regarding export ……6.81mg
….…37mg purpose provided Water for
Magnesium chloride injection(QS)….1000ml
hexahydrate…. 30mg Which contains m moles
equivalent of:
K+ ………..5mmol
MG++ ………3mmol
3. Visosol-M IV infusion 1) Fees Rs.20,000/- GMP inspection dated Visosol-M IV infusion
1000ml 26-01-2018 1000ml
Each 100ml contains: 2) Form 5 concluding that firm Each 1000ml contains:
Dextrose monohydrate was considered to be Dextrose ……….50g
………….5g operating at GOOD Sodium chloride ….1.40mg
Sodium acetate 3) NOC for CRF level of GMP Potassium chloride
anhydrous ….189mg submitted up to compliance. ….…1.219mg
Potassium chloride 31-12-2017 Magnesium citrate
….…141mg Undertaking …..0.65mg
Sodium phosphate regarding export Sodium acetate trihydrate
monobasic..…..21.4mg purpose provided ……2.18mg
Magnesium chloride Water for
hexahydrate …..30.5mg injection(QS)….1000ml
Mono potassium Which contains m moles
phosphate ……15mg equivalent of:
Sodium metabisulfite Na+ ………40-50mmol
……20mg K+ ………..13-30mmol
MG++ ………3mmol
4. Acetovis IV infusion 1) Fees Rs.20,000/- GMP inspection dated Acetovis IV infusion
Each 1000ml contains: 26-01-2018 Each 1000ml contains:
Sodium chloride 2) Form 5 concluding that firm Sodium chloride ….5.96mg
….5.86g was considered to be Potassium chloride
Potassium chloride 3) NOC for CRF operating at GOOD ….…0.30mg
….…0.30g submitted up to level of GMP Calcium chloride
Calcium chloride 31-12-2017 compliance. dihydrate…..0.45mg
dehydrate …..0.29g Sodium acetate trihydrate
Magnesium chloride Undertaking ……3.82mg
hexahydrate …..0.20g regarding export Water for
Sodium acetate purpose provided injection(QS)….1000ml
tetrahydrate……4.08g Which contains m moles
equivalent of:
K+ ………..4mmol
Ca++ ………3mmol
Cl- ………..109mmol
Decision of Chairman RB in 3rd PRVC:-

The Committee evaluated the case in the light of SOPs approved by the Registration Board.
Chairman Registration Board, upon recommendation(s) of Committee decided to refer the case for
Registration Board after submission of valid documents verifying the availability of above products in
Philippine by the firm.
Now the firm has revised the composition and submitted the applications on form 5-D along
with differential fee of Rs.30,000/- per product dated 23-05-2018. The firm has also provided the
evidence of approval of revised formulation in Philippine.
Decision: Registration Board approved the above products for export registration.
Case No.32: 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. No. Brand Name with Generic Initial Dy. No. Status in reference
Registration and date drug agencies & Me-
Letter Date and too
Renewal Status
1. 049374 NBF Injection 12-07-2008 410 DDC  USFDA approved
Each ml contains: Renewal due: R-III  Kinz 10mg/ml
Nalbuphine 11-07-2013 22-02- Injection by M/s
hydrochloride….10mg Renewal applied: 2018 Sami
15-02-2013
Change of brand
name from
Nalbowin to
NBF : 18-10-
2017
2. 040341 Somaline Injection 11-06-2005 411 DDC  ANSM Approved
Each 2ml contains: Change of brand R-III  CT-Nol of M/s Uni-
Citicoline as name from 22-02- Tiech
sodium….250mg Welcoline to 2018 Pharmaceutials,
Somaline : 12- (Reg.#047049)
10-2009
Renewal due: 11-
10-2014
Renewal applied:
29-01-2015
3. 076811 Lecoject Injection 08-04-2013 412 DDC  ANSM Approved
Each ml contains: Renewal due: R-III  Get D injection of
Cholecalciferol ….5mg 07-04-2018 22-02- M/s Getz Pharma
(200,000 IU) Change of brand 2018
name from Wrd-
D to Lecoject:
18-10-2017
Renewal not
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.
The case was considered in 281st meeting of registration Board and the Board decided as follows:
Decision of 281st meeting of Registration Board:
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.
Now the firm has submitted latest GMP inspection report of M/s Walt Danzay Pharmaceutical,
Taxila dated 25-06-2018 concluding that company has shown good response and rectified the problems
and has shown good compliance as per schedule B-II. Moreover the case of renewal of product at S.
No. 2 was considered in 277th meeting of Registration Board and the Board decided to grant/regularize
the renewal of the product till 11-10-2019.

i) Cancellation of registration of above mentioned products from the name of M/s Welwrd
Pharmaceuticals, Plot # 3, Block-A, Phase I-II, Industrial Estate, Hattar.
ii) Grant of registration of above mentioned products in name of M/s Walt Danzay
Pharmaceutical, Taxila.
iii) Reference will be sent to Cost & Pricing Division for MRP of the product.
Case No. 33: Grant of Registration:

Registration Board in its 254th, 276th, 277th, 279th and then in 281st 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 the Reg.No. Brand Name / Label Claim Pack Price Date of Status in
# Firm. Size Submission reference
regulatory
agencies
1. M/s Alza 019888 Zyline 0.40/1.0% Eye Drops 10ml De- 07-08-2015 Couldn’t be
Pharmaceuti Each ml contains:- controll Dy.No.1672 verified.
cals, Zinc Sulphate…….4mg ed Rs.20,000/-
Al-Shifa Boric Acid……….10mg
Trust Eye (As per Innovator’s Specs.)
Hospital, (Astringent)
Jhelum
Road,
Rawalpindi
2. -do- 019889 Demasone Eye Drops 5ml As Per 07-08-2015 USFDA
Each ml contains:- SRO Dy.No.1649 approved
Dexamethasone Sodium Phosphate 471(I)/9 Rs.20,000/-
1.093mg eq. to Dexamethasone 3
Phosphate……..……….1mg
(USP Specs.)
(Corticosteroid)
3. -do- 019890 Demasone-N Eye Drops 5ml De- 07-08-2015 Discontinued
Each ml contains:- controll Dy.No.1666 in USFDA &
Dexamethasone Sodium ed Rs.20,000/- not found
Phosphate 1.093mg eq. to approved by
Dexamethasone Phosphate…..1mg UK.
Neomycin Sulphate eq. to
Neomycin
Base……………....3.5mg
(USP Specs.)
(Corticosteroid and antibiotic)
4. -do- 019891 Tearsol Eye Drops 10ml De- 07-08-2015 Approved in
Each ml contains:- 15ml controll Dy.No.1663 UK-MHRA as
Dextran 70…….……1mg ed Rs.20,000/- Dextran 70…
Hydroxypropyl 1mg and
Methylcellulose….`….0.4% Hydroxypropy
(USP Specs.) l
(Eye Lubricant) methylcellulos
e…3mg/ml
(0.3%).
The firm has

now requested
for change in
composition as
per RRAs.
5. -do- 019892 Gentabiotic 0.3% Eye Drops 5ml As Per 07-08-2015 Discontinued
Each ml contains:- SRO Dy.No.1641 in USFDA
Gentamycin Sulphate BP…3mg 471(I)/9 Rs.20,000/- *Federal
(USP Specs.) 3 Register
(Aminoglycoside Antibiotic) determination
that product
was not
discontinued
or withdrawn
for safety or
efficacy
reasons*
6. -do- 019893 Cromolergic 4% Eye Drops 5ml As Per 07-08-2015 USFDA
Each ml contains:- SRO Dy.No.1639 approved
Cromoglycate Sodium BP…40mg 471(I)/9 Rs.20,000/-
(BP Specs.) 3
(Non-steroidal anti-inflammatory
drugs (NSAIDs)
7. -do- 019894 Cromolergic 2% Eye Drops 5ml De- 07-08-2015 UK-MHRA
Each ml contains:- controll Dy.No.1654 approved
Cromoglycate Sodium BP…20mg ed Rs.20,000/-
(BP Specs.)
(Non-steroidal anti-inflammatory
drugs (NSAIDs)
8. -do- 019895 Tromid Eye Drops 1% 10ml De- 07-08-2015 USFDA
Each ml contains:- controll Dy.No.1661 approved
Tropicamide……….10mg ed Rs.20,000/-
(USP Specs.)
(Anticholinergic)
9. -do- 019897 Predsol 1% Ophthalmic 5ml As Per 07-08-2015 USFDA
Suspension SRO Dy.No.1657 approved
each ml contains:- 471(I)/9 Rs.20,000/-
Prednisolone acetate………..10mg 3
(USP Specs.)
(corticosteroid)
10. -do- 025683 Naphstine 0.025/0.3% Eye Drops 10ml Rs.20.0 07-08-2015 USFDA
Each ml contains:- 15ml 0 Dy.No.1667 approved (as
Naphazoline (as Rs.36.0 Rs.20,000/- OTC drug)
hydrochloride)……0.25mg 0
Pheniramine (as maleate)….3mg
(USP Specs.)
(Decongestant and Antihistamine)
11. -do- 025684 Balanced Salt Solution 500m Rs.250. 07-08-2015 USFDA
Each ml contains:- l 00 Dy.No.1669 approved
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
(Isotonic solution)
12. -do- 025685 Atropin 1% Eye Drops 10ml Rs.12.0 07-08-2015 USFDA
Each ml contains:- 15ml 0 Dy.No.1642 approved
Atropine Sulphate……….10mg Rs.17.0 Rs.20,000/-
(USP Specs.) 0
(Mydriatics, Cycloplegics)
13. -do- 025686 Alklorafen 0.5/0.4% Eye Drops 10ml Rs.19.0 07-08-2015 Not found in
Each ml contains:- 15ml 0 Dy.No.1646 USFDA &
Chloramphenicol Rs.35.0 Rs.20,000/- UK-MHRA
Base…………5mg 0
Hydroxypropylmethylcellulose…
……………..4mg
(USP Specs.)
(Antibiotic)
14. -do- 025687 Askaine 0.5% Eye Drops 10ml Rs.30.0 07-08-2015 USFDA
Ceach ml contains:- 15ml 0 Dy.No.1648 approved
Proparacaine hydrochloride Rs.42.0 Rs.20,000/-
….5mg 0
(USP Specs.)
(Local Anesthetic)
15. -do- 025688 Pilostat 2% Eye Drops 10ml Rs.40.0 07-08-2015 USFDA
Each ml contains:- 0 Dy.No.1658 approved
Pilocarpine hydrochloride.…20mg Rs.20,000/-
(USP Specs.)
(Antiglaucoma Drugs)
16. -do- 025689 Methocel Eye Drops 2.25 Rs.500. 07-08-2015 Not found in
Each ml contains:- ml 00 Dy.No.1673 USFDA &
Hydroxypropylmethylcellulose… Rs.20,000/- UK-MHRA
20mg
Sodium
Chloride………...…6.4mg
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.9.50 07-08-2015 USFDA
Each ml contains:- Dy.No.1659 approved
Sulphacetamide Rs.20,000/-
Sodium…….100mg
(USP Specs.)
(Sulfonamide Antibiotic)
18. -do- 025691 Al-amide 20% Eye Drops 10ml Rs.10.0 07-08-2015 Not found in
Each ml contains:- 0 Dy.No.1650 USFDA &
Sulphacetamide Rs.20,000/- UK-MHRA
Sodium…….200mg
(USP Specs.)
(Sulfonamide Antibiotic)
19. -do- 025692 Tobralux 0.3% Eye Drops 5ml Rs.60.0 07-08-2015 USFDA
Tobramycin……….3mg Rs.20,000/-
(USP Specs.)
(Aminoglycoside Antibiotic)
20. -do- 031204 Shifopin 0.03% Eye Drops 5ml Rs.80.0 07-08-2015 USFDA
Flurbiprofen Sodium……0.3mg Rs.20,000/-
(USP Specs.)
(Nonsteroidl Anti-inflammatory)
21. -do- 031206 Cyclocil 1.0% Eye Drops 10ml Rs.90.0 07-08-2015 USFDA
Cyclopentolate HCl……….10mg Rs.20,000/-
(USP Specs.)
(Cycloplegic)
22. -do- 031207 Al-Fenac 0.1% Eye Drops 5ml Rs.80.0 07-08-2015 UK-MHRA
Each ml contains:- 0 Dy.No. 1643 approved
Diclofenac Sodium………1mg Rs.20,000/-
(NSAIDs)
23. -do- 031208 Flobacin 0.3% Eye Drops 5ml Rs.80.0 07-08-2015 USFDA
Ofloxacin………..3mg Rs.20,000/-
(USP Specs.)
(Fluroquinolone Antibiotic)
24. -do- 031209 Tetrachrom Eye Drops 10ml Rs.110. 07-08-2015 Not found in
Sodium Cromoglycate Rs.20,000/- UK-MHRA
BP……40mg
Tetrahydrozoline HCl
USP….0.5mg
(Anti-Allergics)
25. -do- 031210 Shifol 0.5% Eye Drops 5ml Rs.80.0 07-08-2015 UK-MHRA
Timolol ………5mg as timolol Rs.20,000/-
Maleate………….6.8mg
(USP Specs.)
(Anti-Glucoma Agent)
26. -do- 049229 Shifsone 0.5/0.1% Eye Drops 5ml Rs.20.0 07-08-2015 Not found in
Chloramphenicol……… 5mg Rs.20,000/- UK-MHRA
Dexamethasone as Sodium
Phosphate………….…..1mg
(Alza’s Specs.)
(Corticosteroid and Antibiotic)
27. -do- 049230 Shifeye 0.3/0.1% Eye Drops 5ml Rs.102. 07-08-2015 USFDA
Tobramycin…………….…..…3m 00 Dy.No.1675 approved
g Rs.20,000/-
Dexamethasone (as
Phosphate)...1mg
(USP Specs.)
(Corticosteroid + Antibiotic)
28. -do- 026389 Alciprox 0.3% Eye Drops 5ml Rs.90.0 07-08-2015 USFDA
Ciprofloxacin HCl Monohydrate Rs.20,000/-
0.35% eq. to ciprofloxacin Base
………….……0.3%
(USP Specs.)
(Quinolone Antibiotic)

 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 of 281st meeting of Registration Board:

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.
Decision: Registration Board did not accede to the request of the firm for change of
registration holder from Al-Shifa Eye Trust to M/s Alza Pharmaceuticals,
Rawalpindi since the firm has applied after the validity period of DML of
registration holder.
Registration-IV Section
Case No.34. Issuance of Registration letter of M/s. WeatherFolds Pharmaceuticals, Hattar for their
deferred product “Resile Syrup”.
The case of product “Resile Syrup” of M/s. WeatherFolds was discussed in 276 th m
eeting of DRB. The Board deferred the case for submission of evidence of availability of RI Detector by the
firm. Now the firm has submitted the copy of invoice which indicates that the firm has purchased RI Detector,
therefore, the case is placed for reconsideration of the case for issuance of registration letter.
Registration Contract Reg. Brand Name & Date of
Holder Manufacturer No. Composition Application/ Dy.
No./Fee
M/s. Weather M/s. Dyson 056343 Resile Syrup Each 5ml 02-07-2015 Dy.
Fold Pharma, Research Labs, contains:- 1046 Rs.50,000/-
Hattar Lahore Lactulose …..3.35gm
(Manufactures Spec)
Decision: Deferred for confirmation of availability of RI Detector by area FID along with details of
IQ, OQ & PQ.
Case No.35. Change of Specifications of registered products “Lantol-30mg Tablets” and “Intervirin-
400mg Capsule” of M/s Genome Pharmaceuticals from Manufacturer’s Specifications to
B.P. Specifications and USP Specifications, respectively.
M/s. Genome Pharmaceuticals stated that their finished product mentioned below are registered as
“Genome Specifications” and now testing methods are given in B.P. official Monograph. Details are as under:
-
S.NO. Reg. No. Name of Products Composition Reference
1. 060853 Lantol-30mg Tablets Lansoprazole…..30mg BP 2017 Vol.03 Page 783
2. 052917 Intervirin-400mg Ribavirin…400mg USP41 NF36 Page3597
Capsule
Now firm has applied for change of finished product specifications of the above-referred products from
“Genome Specifications” to B.P. Specifications for product at S.No. 1 and to USP Specifications for product at
S.No.2.
Decision: Registration Board deferred the above mentioned case for complete details and requisite Fee.
Case No.36. Change of Specifications of registered products of various firms consequent upon the
decisions taken by the Chairman Post Registration Variations Committee (PRVC) in its
9th meeting.
Chairman, Post Registration Variations Committee along with members of Committee considered
various cases presented in the 9th PRVC meeting and decided to refer the following cases into the upcoming
meeting of Registration Board, details whereof is mentioned along-side each product in the following table:-
Sr. Name of Reg. Composition & Name Present Specifications Proposed
NO. Firm No. Specifications of & Remarks Change of
Produ Specifications
ct & Corrections
1. M/s 040350
Welcef Dry Powder Injection (Welwrd Specifications)
Welwrd Each vial contains:-
Pharma Ceftriaxone (as API’s Specifications
Hattar. Sodium).U.S.P..250mg mentioned in
2. 040351 Welcef Dry Powder TRIANO formulation needs (Welwrd
Injection M consideration. Specifications)
Each vial contains:- To
Ceftriaxone (as Moreover, the USP 39 (USP
Sodium).U.S.P..500mg at page No. 3044 gives Specifications)
3. 040352 Welcef Dry Powder finished product
Injection specifications for
Each vial contains:- Ceftriaxone Sodium
Ceftriaxone (as
Sodium).U.S.P..1.0gm
4. M/s 064389 Mactic 400mg Tablet Moxza (Welmark (Welmark
Welmark Each Tablet contains: - m Specifications) Specifications)
Pharma Moxifloxacin…400mg To
Hattar. (Welmark Specification) In accordance with (As per
the decisions of the Innovator’s
Registration Board. Specifications)
5. M/s 075590 Renelate 2g Sachet Rezole (Wnsfeild (Wnsfeild
Wnsfeild Each sachet contains:- t Specifications) Specifications)
Pharma Strontium Ranelate …..2 gm To
Hattar. (Wnsfeild Specification) In accordance with (As per
the decisions of the Innovator’s
Registration Board. Specifications)
The EMA on 13th May 2013 & 21st

February 2014 decided that this drug
should only be used in severe cases of
post-menopausal women osteoporosis and
it should not be used in patients of
uncontrolled hypertension, or patients with
current or past history of ischemic heart
disease, or peripheral artery disease or
cerebrovascular disease.
6. M/s 073398 Cepmol Suspension Cepmo (BP Specifications) Cepmol
Caliph Each 5ml contains: l Suspension
Pharma Paracetamol….125mg The firm wants to Each 5ml
Risalpur. (BP Specification) standardize its contains:
formulation because Paracetamol….
approved formulation 125mg
in UK by MHRA is (BP
Paracetamol Specification)
Suspension (Each 5ml To
containing 120mg of Cepmol
Paracetamol). Suspension
Each 5ml
contains:
Paracetamol….
120mg
(BP
Specification)
7. M/s Hicon 041519 Hydrim Syrup Hydri Firm wants to modify Hydrim Syrup
Pharma Each 5ml contains: m the formulation and Each 5ml
Peshawar. Aminophyllin--32mg Syrup convert Menthol from contains:
Diphenhydramine--8mg Active Ingredient to Aminophyllin--
Ammonium Chloride---- Inactive Ingredient. 32mg
30mg Diphenhydramine
Menthol----0.98mg Firm had also produced --8mg
reference of other such Ammonium
registered formulations. Chloride----30mg
e.g. Cibocos Syrup of Menthol----
M/s. Cibex, Smocol 0.98mg
Syrup of M/s. Fedrao,
Adalin Syrup of M/s. To
Macter, and Zayrollin
Syrup of M/s. Hydrim Syrup
Zaynoon. Each 5ml
contains:
Aminophyllin--
32mg
Diphenhydramine
--8mg
Ammonium
Chloride----30mg
Inactive
Ingredient
Menthol----
0.98mg
Decision: The Registration Board decided as following:-

i. For products at S.No. 1-3, approved the change of specifications from (Welwrd Specifications
to USP Specifications) and also approved omission of specifications of API in accordance with
the previous decisions of Registration Board;
ii. For products at S.No. 4, approved the change of specifications from (Welmark Specifications
to As per Innovators Specifications) as per decisions of Registration Board;
iii. For products at S.No. 5, approved the change of specifications from (Wnsfeild Specifications
to As per Innovators Specifications) as per decisions of Registration Board. Further the Board
also approved that the firm be directed to specify clearly upon leaflet that the product only be
used in severe cases of post-menopausal women osteoporosis and it should also be clearly
contraindicated in patients of uncontrolled hypertension, or patients with current or past
history of ischemic heart disease, or peripheral artery disease or cerebrovascular disease; and
iv. For products at S.No. 6 and 7, deferred the products for clarification with regard to
availability in reference regulatory authorities.
Registration-V
Case No.37: Correction in formulation for the product of M/s. Himont Pharmaceuticals (Pvt)
Ltd. Lahore
M/s. Himont Pharmaceuticals (Pvt) Ltd. Lahore has requested for correction in formulations of below
mentioned products as per detailed below:-
Sr.No Reg. No Name of Drug(s) & Composition Proposed correction
1. 019151 Hicap Drops Hicap Drops
Each vial contains: Each vial contains:
Vitamin A………5000 IU USP Vitamin A (Vitamin A Palmitate) ……5000 IU
Vitamin B1………….2mg BP Vitamin B1 (Thiamine Hydrochloride)
Vitamin B2…………..1mg BP ……………………………………………...2mg
Nicotinamide…………10mg BP Vitamin B2 (Riboflavin Sodium Phosphate)
Vitamin B6…………….1mg BP ……………………………………………...1mg
Dexpanthenol………10mg USP Nicotinamide …………………….………..10mg
Biotin (Vit.H)……….0.1mg USP Vitamin B6 (Pyridoxin
Vitamin C…………..50mg USP Hydrochloride)…………..1mg
Vitamin D…………..10mcg USP Dexpanthenol ……………………………10mg
Vitamin E……………3mg USP Biotin (Vitamin H) ……………………..0.1mg
Vitamin C (Ascorbic Acid)……………..50mg
Vitamin D (Cholecalciferol Concentrate Powder)
……………………………………….....10mcg
Vitamin E (Tocopheryl Acetate) ...3mg
2. 019149 Pregnovit Tablet Pregnovit Tablet
Each Tablet Contains:- Each Tablet Contains:-
Vitamin A………….6000IU USP Vitamin A (Vitamin A Palmitate) ……..6000IU
Vitamin B1…………..1.6mg BP Vitamin B1(Thiamine Mononitrate) …..1.6mg
Vitamin B2…………..1.8mg BP Vitamin B2(Riboflavin) ………………….1.8mg
Nicotinamide…………19mg BP Nicotinamide …………………………….19mg
Vitamin B6…………2.6mg BP Vitamin B6 (Pyridoxin Hydrochloride)……...2.6mg
Calcion Pantothenate…10mg USP Calcion Pantothenate……………………….....10mg
Biotin (Vitamin H)…..0.2mg USP Biotin (Vitamin H) …….......................0.2mg
Vitamin B12………4mcg USP Vitamin B12(Cyanocobalamin) ………….4mcg
Folic Acid……….0.8mg BP Folic Acid ……………………………....0.8mg
Vitamin C…………100mg BP Vitamin C (Ascorbic Acid) …………….100mg
Vitamin D………….500IU USP Vitamin D(Cholecalciferol) ……………..500IU
Vitamin E…………15mg USP Vitamin E(Tocopheryl Acetate) ………..15mg
Calcium……………125mg BP Calcium (as Tricalcium Phophate)……125mg
Phosphorus…………125mg BP Phosphorus (as Tricalcium Phophate) …125mg
Magnesium………….100mg BP Magnesium(as magnesium Oxide) …….100mg
Iron…………………60mg BP Iron(as Ferrous Fumarate) …………….60mg BP
Copper………………1mg USP Copper(Copper Sulphate) ……………….1mg
Manganese…………1mg USP Manganese(manganese Sulphate) ……….1mg
Zinc…………………7.5mg BP Zinc (as Zinc Oxide) ……………………..7.5mg
3 016049 Hicap M Syrup Hicap M Syrup
Each 5ml contains:- Each 5ml contains:-
Vitamin A …………..1 mg Vitamin A (Vitamin A Palmitate)………..1 mg
Vitamin D …………10 mcg Vitamin D (Cholecalciferol Concentrate
Vitamin B1 ………10 mg Powder)…10 mcg
Vitamin B2 ………………10 mg Vitamin B1 (Thiamine Hydrochloride)…10 mg
Vitamin B6 …………….1 mg Vitamin B2 (Riboflavin Sodium Phosphate)..10 mg
Vitamin B12 ………………..5 mcg Vitamin B6 (Pyridoxin Hydrochloride)….1 mg
Vitamin E ………………25 I.U Vitamin B12 (Cyanocobalamin)………..5 mcg
Vitamin C …………………150 mg Vitamin E (Tocopheryl Acetate)..25 I.U
Calcium ……………………..5 mg Vitamin C (Ascorbic Acid)…………150 mg
Calcium …………50 mg Calcium (as Calcium pantothenate) ……..5 mg
Iron …………….3 mg Calcium (as Calcium Chloride Dihydrate)…50 mg
Iodine …………….75 mcg Iron (as Ferrous Gluconate) …………….3 mg
Magnesium ……………..5 mg Iodine (as Sodium Iodide)…………….75 mcg
Copper …………..0.1 mg Magnesium (as Magnesium Chloride
Zinc ……………..1 mg Hexahydrate)…… ..5 mg
Nicotinamide ……………20 mg Copper (as Chloride Dihydrate)……. ..0.1 mg
Phosphorous ………50 mg Zinc (as Copper Zinc Citrate )
Choline ……………..10 mg Manganese (as Manganese Chloride
Inositol…………………10 mg Tetrahydrate)……. ..1 mg
Lysine ……….20 mg Nicotinamide ………………………20 mg
Phosphorous (as Sodium Dihydrogen Phosphate
Dihydrate) ….50 mg
Choline (as Choline Bitartrate) …..10 mg
Inositol…………………………………10 mg
Lysine Hydrochloride ………………….20 mg
4 019148 HEPATOVIT TABLETS HEPATOVIT TABLETS
DI-Methionine ……100 mg DL-Methionine ………………………100 mg
Choline Tartrate (USP)100 mg Choline Tartrate…………………….…..100 mg
Vitamin B1…………….…2 mg Vitamin B1(Thiamine Mononitrate) ……2 mg
Vitamin B2………….….2 mg Vitamin B2(Riboflavin) ………………....2 mg
Nicotinamide (BP)…….6 mg Nicotinamide ……………………………6 mg
Vitamin B6 ………….…..2 mg Vitamin B6 (Pyridoxin) HCl …………..2 mg
Dexpanthenol (BP)……3 mg Dexpanthenol ……………………………3 mg
Biotin (BP) …….0.1 mg Biotin ………………………………….0.1 mg
Folic Acid (BP)……..0.4 mg Folic Acid ……………………………..0.4 mg
Vitamin B12(BP……0.67 mcg Vitamin B12 (Cyanocobalamin) ……0.67 mcg
Vitamin E (BP)………3 mg Vitamin E (Tocopheryl Acetate) ……3 mg
5 016048 Hicap M Tablet Hicap M Tablet
Vitamin A (BP) ……….5000 IU Vitamin A (Vitamin A Acetate)) ….5000 IU
Vitamin D (BP) …………..500 IU Vitamin D (Cholecalciferol) …………..500 IU
Vitamin B1 ……10 mg Vitamin B1 (Thiamine Mononitrate) ……10 mg
Vitamin B2 …………….10 mg Vitamin B2 (Riboflavin) …………….10 mg
Vitamin B6 ………….4 mg Vitamin B6 (Pyridoxin HCl) …………….4 mg
Vitamin B12 ……..5 mcg Vitamin B12 Cyanocobalamin ………..5 mcg
Vitamin E ……50 IU Vitamin E (Tocopheryl Acetate) ………50 IU
Vitamin C………300 mg Vitamin C(Ascorbic Acid) ……………300 mg
Calcium Pantothenate..20 mg Calcium Pantothenate(Calcium Pantothenate)
Folic Acid (BP)……..1 mg …………………………………………20 mg
Biotin (BP)………….300 mcg Folic Acid ……………………………..1 mg
Calcium………...100 mg Biotin …………………………….300 mcg
Iron …….50 mg Calcium(as Tricalcium Phohphate )..100 mg
Iodine ……..100 mcg Iron (as Ferrous Fumarate) …….50 mg
Magnesium …….10 mg Iodine (as Potassium Iodide) ……..100 mcg
Copper ………2 mg Magnesium (as Magnesium Oxide) …….10 mg
Zinc ……….15 mg Copper (as Copper Sulphate) …………2 mg
Manganese……5 mg Zinc (as Zinc Oxide) ………….15 mg
Chromium..15 mcg Manganese(Manganese Sulphate) ……5 mg
Selenium ………15 mcg Chromium (as Potassium Dichromate) ..15 mcg
Molybdenum ……15 mcg Selenium (as Selenium Dioxide) ………15 mcg
Potassium …….7.5 mg Molybdenum (as Sodium Molybdate) …15 mcg
Nicotinamide ……….50 mg Potassium (as Potassium Sulphate) …….7.5 mg
Phosphorus ………25mg Nicotinamide (Nicotinamide) ………….50 mg
Phosphorus (as Tricalcium Phosphate) ….25 mg
6 003745 Hicap SS Tablet Hicap SS Tablet
Each Tablet contain:- Each Tablet contain:-
Vitamin A………..5500 IU Vitamin A (Vitamin A
Vitamin D………….400IU Acetate)…………….…………...5500 IU
Vitamin E…………..30IU Vitamin D (Cholecalciferol concentrate
Vitamin C…………….120mg powder)…………………………...400IU
Vitamin B1…………….3mg Vitamin E (Tocopheryl
Vitamin B2………….3.4mg acetate)………………..…………..30IU
Niacin…………………30mg Vitamin C (Ascorbic
Vitamin B6…………….3mg acid)……………………………….120mg
Vitamin B12…………….9mcg Vitamin B1 (Thiamine
Pantothenic Acid……..10mg Mononitrate)…………………….3mg
Folic Acid……………0.4mg Vitamin B2 (Riboflavin)………….3.4mg
Biotin …………………15mcg Niacin(as Nicotinamide)……………30mg
Iron……………………….27mg Vitamin B6 (Pyridoxin
Iodine…………………150mcg HCl)………………..…………….3mg
Magnesium……………..100mg Vitamin B12 (Cyanocobalamin)……….9mcg
Copper…………………..2mg Pantothenic Acid (Calcium
Zinc………………………15mg Pantothenate)…………………..10mg
Manganese……………….5mg Folic Acid ………………………0.4mg
Calcium…………………40mg Biotin…………………………15mcg
Selenium………………….10mcg Iron(as ferrous
Chromium………………15mcg fumarate)……………………….27mg
Molybdenum……………15mcg Iodine (as potassium
Potassium………………..7.5mg iodide)……………………….…150mcg
Chloride…………………7.5mg Magnesium (as magnesium
oxide)…………………………...100mg
Copper (as copper
sulphate)…………………………..2mg
Zinc (as zinc oxide)………………………15mg
Manganese (manganese
sulphate)…………………………...5mg
Calcium (as tricalcium
phosphate)………………………40mg
Selenium (as selenium
dioxide)………………….10mcg
Chromium (as potassium
dichromate)………………15mcg
Molybdenum (as sodium
molybdate)……………15mcg
Potassium (as potassium
chloride)………………..7.5mg
Chloride (as potassium
chloride)…………………7.5mg
Firm has submitted supportive material/evidence (official monographs/ Certificate of Analysis)

regarding use of proposed salts in applied dosage forms.
Decision: Registration Board acceded to request of firm for correction in formulation from
existing to proposed formulation.
Case No.38: Grant of Registration in the name of M/s. Seatle (Private) Limited, Lahore.
M/s. Seatle (Private) Limited, Lahore has requested for change of registration status of following
product of M/s. Martin Dow Limited, Karachi as per detailed below:-
Sr. No Reg. No Name of product & formulation Remarks
1. 080645 Maysa 500mg Capsule M/s Seatle requested for brand
Each capsule contains:- name change and submitted
Cefadroxil monohydrate eq. to alternate brand names:
Cefadroxil…………………..500mg Dowxil
(USP Specification) Efadroxil
Marticef
The brand name Dowxil has

been selected due to non
resemblance with any other
registered product.
The firm has submitted following documents.

i. Application with fee of Rs.20000/- for this purpose.
ii. Form-5.
iii. NOC for transfer of registration
iv. Copy of Registration letter.
v. Evidence of section approval i.e capsule section (cephalosporin) dated
23.11.2015
vi. Latest GMP inspection report (within 1 year) not provided by M/s. Seatle
(Private) Limited, Lahore
Decision: Registration Board deferred request of firm for NOC (within 3 months) and latest
GMP inspection report (within 1 year)
Case No.39: Correction in formulation for the product of M/s. Star Laboratories (Pvt) Ltd.
Lahore
M/s. Star Laboratories (Pvt) Ltd. Lahore has requested for correction in formulation of below
mentioned product as per detailed below:-
Reg. No Name of Drug(s) & Composition Proposed correction Proposed
route of
administration
026866 Rocetrax-100 Injection IV,IM Rocetrax-100 Injection
Each 10ml vial contains:- Each vial contains:- I.V
Ceftriaxone sodium…….1000mg Ceftriaxone
Each 2ml ampoule contains:- (as sodium)….1.0gm
Lignoocaine HCl…………..10mg (USP Specification)

ii. Form-5 and relevant documents.
iii. Copy of Registration letters with renewal status (last renewal dated 28.03.2016)
iv. Documents for reference.
Decision: Registration Board acceded to request of firm for correction in formulation with
proposed route of administration i.e I.V
Case No.40: Registration for the products of M/s. Tagma Pharma (Pvt) Ltd, Lahore
Registration Board in different meetings considered following products of M/s. Tagma Pharma (Pvt)
Ltd, Lahore as per detailed below:-
Sr.No Name of firm Name of product and Demanded Remarks
composition MRP/pack
size
1. M/s.Tagma Notense Tablets 30’s MHRA approved
Pharma Lahore Each tablet contains:- As Per SRO Decision (M-224)
Alprazolam…..0.5mg Deferred for Narcotic policy.
2. -do- Lexolite Tablets 30’s HPRA Ireland Approved
Each tablet contains:- As Per SRO
Bromazepam…..3mg Decision (M-224)
(Antipsychotics) Deferred for Narcotic policy.
3. -do- Kavin Tablets 100’s MHRA approved
Each tablet contains:- As Per SRO
Pentazocine as Hcl ….25mg Decision (M-226)
Approved subject to fulfillment
of policy
4. -do- Butag Tablets 5×10’s Approval status in reference
Each tablet contains:- As Per SRO countries not confirmed
Buprenorphine as HCl
……………….0.2mg Decision (M-226)
Approved subject to fulfillment
of policy
5. -do- T-Dal Capsules 10’s MHRA approved
Each capsule contains:- As Per SRO Decision (M-226)
Tramadol HCl………50mg Deferred for confirmation of
separate section from licensing.
6. -do- Celesta Tablets 10’s MHRA approved formulation is
Each tablet contains:- As Per SRO Zolpidem tartrate
Zolpidem Decision (M-228)
Hemitartrate….10mg Approved subject to approval of
separate section by licensing
Board.

i. Application with differential fee of Rs.12000/- for each product this purpose.
ii. Form-5
iii. Psychotropic section approval dated 14th June, 2018 (New section)

a) Approved products at Sr. no. 1,2,3 and 5.
b) Deferred product at Sr. no. 4 for confirmation of approval status in any reference
regulatory authority
c) Deferred product at Sr. no. 6 for clarification of applied salt w.r.t formululation approved
in reference country.
Case No.41: Change in formulation for the product of M/s. Unison Chemical Works, Lahore
M/s. Unison Chemical Works, Lahore has requested for correction in formulations of below mentioned
product as per detailed below:-
Reg. No Name of Drug(s) & Composition Proposed change Rermarks
038051 Dompro Suspension Dompro Suspension Due to complaints
Each 5ml contains:- Each 5ml contains:- from market regarding
Domperidone Maleate 6.36mg eq to Domperidone bitter taste firm intends
Domperidone base…………5mg ……..…………5mg to change formulation
ii. Form-5.
iii. Copy of Registration letters with renewal status (last renewal dated 12.05.2015)
Decision: Since both formulations are available in reference countries hence change in
formulation is not permissible by Registration Board
Case No.42: Registration for the products of M/s. Radiant Pharma (Pvt) Ltd. Lahore.
Registration Board in 237th meeting considered the products of M/s. Radiant Pharma (Pvt) Ltd. Lahore
as per detailed below:-
Sr.No Name of firm Name of product and Demanded Demanded Remarks
composition pack size MRP
1. M/s.Radiant Ramodine Suspension 60ml Rs.45/- FDA approved
Pharma (Pvt) Ltd, Each 5ml contains:- formulation is
43-E Sundar Famotidine…10mg 40mg/5ml
Industrial Estate, (Antacid)
Sundar Raiwind
Road, Lahore.
2. -do- Ferfolic Tablets 10’s As per SRO

Each tablet contains:-
Iron polymaltose …..100mg
Folic acid ….0.35mg
(haematinic)
3. -do- Radibron Dry Syrup 120ml As per SRO FDA approved
Each 5ml contains:- formulation
Erythromycin…..200mg Erythromycin
(macrolide) ethyl succinate
oral granules for
suspension
4. -do- Radmol Liquid Syrup 60ml -do- MHRA approved
Each 5ml contains:-
5. -do- Radimether Dry Syrup 60ml -do- WHO approved
Each 5ml contains:-
Artemether….15mg
Lumefantrine…90mg
6. -do- Ramocine Capsule 10’s -do- Not confirmed in

Each capsule contains:- SRA
7. -do- Ramocine SR Capsule 10’s -do- Not confirmed in
Each capsule contains:- SRA
8. -do- Radiflox Dry Syrup 60ml As per SRO MHRA approved
Each 5ml contains:- 120ml
Ciprofloxacin ….250mg
9. -do- Radiflox Dry Syrup 60ml -do- Approved by
Each 5ml contains:- Registration
Ciprofloxacin….125mg Board in 269th
meeting
i. Application for this purpose.
ii. Evidence for fee submission i.e Rs 20,000/- per product
iii. Latest GMP inspection report (within 1 year) not provided by the firm.
Decision: Registration Board deferred the request of firm for latest GMP inspection report
within 1 year period.
Case No.43: Registration for the products of M/s. Elvin Pharmaceuticals (Pvt) Ltd, Lahore.
Registration Board in 235th meeting considered the products of M/s. Elvin Pharmaceuticals (Pvt) Ltd,
Lahore (formerly M/s. Empire Pharma, Lahore )as per detailed below:-
Sr.No Name of firm Name of product and Demand Demande Decision

composition ed pack d MRP
size
1. M/s. Empire Disprox dispersible Tablets 2x10 As pre MHRA approved (as
Pharma, Lahore. Each tablet contains:- SRO beta cyclodextrin)
Piroxicam……..20mg
(NSAIDS) Deferred for the
confirmation of the
section of the firm and
completion of
registration dossier.
2. -do- Revive Tablets 3x10 As per -do-
Each tablet contains:- SRO
Sertraline………50mg MHRA approved
(Anti-Depressants)
3. -do- Gem Tablets 1x7 As per -do-
Gemifloxacin USFDA approved
Mesylate……..320mg
(Floroquniolones)
4. -do- Oflocid Tablets 1x10 As per -do-
Ofloxacin………200mg
(Quinolones/anti-biotic) MHRA approved
5. -do- Artimel Tablets 1x8 As per -do-
Artimether……….80mg WHO approved
Lumefantrine…….480mg
(Anti-malarial)
6. -do- Melton Tablets 1x10 As per -do-
Nimesulide……….100mg Approved by EMA
(NSAID)
7. -do- Dolonap Tablets 2x10 As per -do-
Naproxen USFDA approved
Sodium………550mg
(Anti-reheumatic/ propionic
acid/ Nsaid)
8. -do- Pattern Tablets Not As per -do-
Each tablet contains:- mention SRO
Escitalopram…….10mg USFDA approved
(Anti-Depressants)
9. -do- Pantazole 10mg Tablets 2x7 As per -do-
Pantoprazole………10mg Approval status not
(Anti-peptic ulcerant) confirmed in SRA with
10mg strength
10. -do- Regain Tablets 2x10 As per -do-
Each tablet contains:- SRO PMDA approved
Mecobalamin……..500mcg
(Co-enzyme Type Vitamin
B12)
11. -do- Mycin Tablets 1x6 As per -do-
Azithromycin…….250mg MHRA approved
(Macrolides)
12. -do- Levin Tablets 1x10 As per -do-
Each tablet contains:- SRO MHRA approved
Levofloxacin………500mg
(Quinolone/ anti-biotic)
13. -do- Elerotek Tablets 1x10 As per -do-
Clarithromycin……..500m MHRA approved
g
(Macrolides)
14. -do- Regulate Tablets 1x10 As per -do-
Levosulpride………25mg Approved in Italy
(Anti-depressants)
15. -do- Zacin Tablets 1x10 As per USFDA approved
Ciprofloxacin………500m Deferred for the
g confirmation of the
(Quinolones) section of the firm and
completion of
registration dossier.
16. -do- Emrald Tablets 2x7 As per -do-
Esomeprazole……..20mg MHRA approved
(anti-peptic ulcerants)
17. -do- Moxin Tablets 1x5 As per -do-
Moxifloxacin……..400mg MHRA approved
(Quinolones)
18. -do- Emrald Tablets 2x7 As per -do-
Esomeprazole……….40mg MHRA approved
(Anti-peptic ulcerants)
19. -do- Artimel Tablets Not As per -do-
Each tablet contains:- mention SRO
Artemether………20mg WHO approved
Lumefantrine………120mg
(Anti-malarial)
20. -do- Zacin Tablets 1x10 As per -do-
Ciprofloxacin…250mg USFDA approved
(Quinolones)
21. -do- Tomat Tablets 6x10 As per -do-
Topiramate………..50mg USFDA approved
(Anti-epilptics)
22. -do- Aldonate Tablets 1x10 As per -do-
Each tablet contains:- SRO USFDA approved
Alendronate Sodium..10mg
(Bone Metabolism)
23. -do- Pearl Tablets 2x10 As per -do-
Piroxicam-Beta- ANSM approved
Cyclodextrin………..20mg
(NSAIDS)
24. -do- Levin Tablets 1x10 As per -do-
Levofloxacin…..250mg MHRA approved
(Quinolone/ Anti-biotic)
25. -do- Elerotek Tablets 1x10 As per -do-
Clarithromycin….250mg MHRA approved
(Macrolides)
26. -do- Pecan Tablets 2x10 As per -do-
Each tablet contains:- SRO Approval status in
Diclofenac Potassium.75mg SRA confirmed
(NSIADS)
i. Application for this purpose.
ii. Evidence of fee submission i.e 12000/- not verified
iii. Last GMP inspection report (within 1 year) not provided by the firm
Decision: Registration Board deferred the request of firm for latest GMP inspection report
within 1 year period.
Case No.44: Correction in formulation for the product of M/s. Irza Pharma (Pvt) Ltd, Lahore
The request of M/s. Irza Pharma (Pvt) Ltd, Lahore was deferred in 278th meeting for correction in
formulation of below mentioned registered product as per detailed below:-
Sr.No Reg. No Name of Drug(s) & Proposed correction Remarks
Composition
1. 017622 Irazacin Suspension Irazacin Suspension Approval status in
Each 5ml contains:- Each 5ml contains:- SRA not confirmed
Erythromycin Estolate eq. to Erythromycin Estolate eq to with Estoate salt
Erythromycin…200mg Erythromycin………125mg
The firm is submitting renewal as Irzacin suspension (Reg no. 017622) as 125mg/5ml instead of
200mg/5ml. However, Irzacin suspension 200mg/5ml is registered having registration no. 064815
(dated 5th August, 2010)
Decision: Registration Board decided to provide opportunity of personal hearing to M/s. Irza Pharma
(pvt) Ltd, Lahore for deliberating the matter.
Decision: Registration Board considered the case and decided to defer for information from
DRAP, Lahore office.
Case No. 45: Contract manufacturing permission to M/s. Ideal Pharmaceuticals Industries,
Lahore:
M/s. Ideal Pharmaceuticals Industries, Lahore applied for contract manufacturing permission from
M/s Ameer Pharma, Lahore for below mentioned registered products :
S# No Applicant Contract Name of Drug (S) & Reg# Date of Reason/
Manufactu Composition Application/ justification
re Fee
1. M/s. Ideal M/s Ameer Iodofen tablet 200mg 018621 Rs.50000/- Firm intends to
Pharmaceutic Pharma, Each tablet contains:- Dated shift
als Industries, Lahore, Ibuprofen………200mg Renewal 17.05.2018 manufacturing
Lahore valid Dy No. plant to new site
18315/R&I in order to avoid
Dated shortage of
18.05.2018 medicine in
market firm
applied for
contract
manufacturing
during interim
period. However
firm DML is valid
also confirm from
Licensing
Division.
2. -do- -do- Lizrin Cough Syrup 008552 Rs.50000/- -do-
Eah 5ml contains:- Dated
Ammonium Renewal 17.05.2018
chloride……100mg valid Dy No.
Sodium citrate…60mg 18319/R&I
Chlorpheniramine Dated
maleate……..2mg 18.05.2018
Ephedrine
HCl…….7mg
Menthol…………1mg
3. -do- -do- Cetalix Elixir 010853 Rs.50000/- -do-
Each 5ml contains:- Dated
Paracetamol Renewal 17.05.2018
B.P….120mg valid Dy No.
18320/R&I
Dated
18.05.2018
4. -do- -do- Iodofen Suspension 024089 Rs.50000/- -do-
Ibuprofen………100mg Renewal 17.05.2018
valid Dy No.
18317/R&I
Dated
18.05.2018
5. -do- -do- Calcium Lactate 300mg 004221 Rs.50000/- -do-
Each tablet contains:- Dated
Calcium Renewal 17.05.2018
Lactate…..300mg valid Dy No.
18318/R&I
Dated
18.05.2018
6. -do- -do- Soda Mint Tablet 004220 Rs.50000/- -do-
Sodium Renewal 17.05.2018
Bicarbonate…..300mg valid Dy No.
18316/R&I
Dated
18.05.2018
7. -do- -do- Co-Trimax Suspension 008552 Rs.50000/- -do-
Trimethoprim…40mg Renewal 17.05.2018
Sulphamethoxazole…2 valid Dy No.
00mg 18333/R&I
Dated
18.05.2018
8. -do- -do- Paracetamol Tablet 005704 Rs.50000/- -do-
Paracetamol……500mg Renewal 17.05.2018
valid Dy No.
18321/R&I
Dated
18.05.2018
9. -do- -do- Chlorpheniramine 006811 Rs.50000/- -do-
Maleate tablet Dated
Each tablet contains:- Renewal 17.05.2018
Chlorpheniramine valid Dy No.
Maleate………4mg 18322/R&I
Dated
18.05.2018
10. -do- -do- B Compound Tablet 007239 Rs.50000/- -do-
Vitamin B1………1mg Renewal 17.05.2018
Vitamin B2………1mg valid
rd th
Minutes for 283 meeting of Registration Board, DRAP (27-29 June, 2018) 538
Nicotinamide……15mg Dy No.
18323/R&I
Dated
18.05.2018
11. -do- -do- Canon Tablet 500mg 029444 Rs.50000/- -do-
Ciprofloxacin HCl eq. Renewal 17.05.2018
to valid Dy No.
Ciprofloxacin…500mg 18324/R&I
Dated
18.05.2018
12. -do- -do- Canon Tablet 250mg 029443 Rs.50000/- -do-
Ciprofloxacin HCl eq. Renewal 17.05.2018
to valid Dy No.
Ciprofloxacin…250mg 18326/R&I
Dated
18.05.2018
13. -do- -do- Co-Trimax Tablet 008550 Rs.50000/- -do-
Trimethoprim…80mg Renewal 17.05.2018
Sulphamethoxazole valid Dy No.
……400mg 18337/R&I
Dated
18.05.2018
14. -do- -do- Optel-P tablet 026919 Rs.50000/- -do-
Diclofenac Renewal 17.05.2018
Potassium…..50mg valid Dy No.
18325/R&I
Dated
18.05.2018
15. -do- -do- Iodopyrin Tablet 007602 Rs.50000/- -do-
Each tablet contains;- Dated
Aspirin……….300mg Renewal 17.05.2018
Paracetamol……..75mg valid Dy No.
Caffeine…………10mg 18334/R&I
Dated
18.05.2018
16. -do- -do- Neurostress Syrup 008538 Rs.50000/- -do-
Thiamine HCl…..3mg Renewal 17.05.2018
Riboflavin……..3mg valid Dy No.
Pyridoxine HCl….2mg 18332/R&I
Nicotinamide…..23mg Dated
18.05.2018
i. Application with copy of fee challan of Rs.50000/- (dated 17.05.2018) each
product for this purpose.
ii. Form-5.
iii. Copy of contract manufacturing agreement (dated 10.05.2018)
iv. Copy of Registration letters with renewal status.
v. Latest GMP inspection report of M/s Ameer pharma.
vi. Undertaking to complete new manufacturing site within 24 months
Decision: Registration Board approved contract manufacturing of above products from M/s
Ameer Pharma, Lahore as per Rule 20-A(1)(c) of Drugs (Licensing, Registering &
Advertising, Rules) 1976. Permission shall be at same terms and conditions and valid
for period of 24 months. Contract manufacturing permission will be issued after
following steps:
a. Approval of layout plan of new manufacturing site by Licensing Division, DRAP.

b. M/s Ideal Pharma, Lahore will submit timelines for establishment of manufacturing
facility for above products at new manufacturing site. Firm will submit quarterly
progress report on the activities undertaken under the aforementioned submitted plan
for appraisal of Registration Board. In case of non-compliance for above time lines,
case shall be placed before Registration Board for taking necessary action.
c. GMP inspection of M/s M/s Ameer Pharma, Lahore.
d. An undertaking that during contract manufacturing period, DML of existing site will
remain valid. In case of non-compliance, contract manufacturing peremission will be
withdrawn.
Case No.46: Contract manufacturing permission to M/s Lahore chemical and pharmaceutical
works (pvt) Ltd.
M/s Lahore chemical and pharmaceutical works (pvt) Ltd has requested for contract manufacturing
of below mentioned product from M/s. Novamed Pharmaceuticals (Pvt) Ltd, Lahore as per detailed
below:-
Reg. No Name of product & formulation Reason/justification
021686 Cimonil Capsule Due to non availablity of cephalosporin
Each capsule contains:- section firm intends to manufacture product
Cefixime……………….400mg by M/s Novamed, Lahore on contract
manufacture basis
Remarks: applied formulation exist in JP.

i. Application with fee of Rs.50000/- for each product for this purpose.
ii. Form-5.
iii. Agreement for contract manufacturing (dated 06th March, 2018)
iv. Copy of Registration letters with renewal status (last date 21.05.2013)
v. Evidence of section approval by CLB (dated 26.07.2016)
vi. Last GMP inspection report dated 5th and 27th December 2017.
Decision: Registration Board deferred the request of firm for confirmation of renewal status
of the product.
Case No.47: Recommendations to DRAP for cancellation of Registrations.
Director DTLs Lahore, Rawalpindi and Multan has requested the Board (PQCB) to recommend the
DRAP for cancellation of registration of the following drugs whose test/analysis methods/specification
were not provided to the Governments Analyst concerned:-
Sr. DTL DI Area DTL letter Date Product manufactur Reason
No. No. Name e
1. Lahore PIC 4837/DTL 5/5/18 Byscard M/s. Searle No response from firm
Lahore Tablet Pakistan to provide Product
Batch No. Specifications and
0365 Method of Analysis.
Request from DTL for
recommendation
cancellation of
registration of the
product.
2. Lahore PIC 4836/DTL 5/5/18 Byscard M/s. Searle No response from firm
Lahore Tablet Pakistan to provide Product
Batch No. Specifications and
recommendation
cancellation of
registration of the
product.
3. Lahore Samanab 4827/DTL 3/5/18 Vit. B. M/s. No response from firm
ad Town Complex Nawabsons to provide Product
Lahore Syrup Laboratories Specifications and
Batch No. , Lahore Method of Analysis.
J18-031 Request from DTL for
recommendation
cancellation of
registration of the
product.
4. Lahore Samanab 4828/DTL 3/5/18 Sodium acid M/s. No response from firm
ad Town citrate Syrup Nawabsons to provide Product
Lahore Batch No. Laboratories Specifications and
J18-025 , Lahore. Method of Analysis.
recommendation
cancellation of
registration of the
product.
5. Lahore Samanab 4828/DTL 3/5/18 Chill Tablets M/s. Everest No response from firm
ad Town 20mg Pharmaceuti to provide Product
Lahore Batch No. cals Specifications and
recommendation
cancellation of
registration of the
product.
6. Lahore Mayo 4681/DTL 18/4/18 Samerol-N- M/s. Sami No response from firm
hospital Forte Pharmaceutito provide Product
Lahore Batch No. cals Specifications and
062C Method of Analysis.
recommendation
cancellation of
registration of the
product.
7. Bahawalp Civil 1071 8/5/18 Solu-Medrol M/s. Pfizer No response from firm
ur Hospital Batch No. Pakistan to provide manufacturer
Bahawal S98819 Ltd. Specifications.
pur
8. Bahawalp Civil 1088 4/5/18 Valium M/s. Martin No response from firm
ur Hospital Batch No. Dow Ltd. to provide manufacturer
Bahawal F1120 Specifications after 90
pur days.
9. Multan PSSHM 1055/DTL 4/5/18 Wintogeno M/s. Merck No response from firm
C Balm Quetta. to provide manufacturer
Hospital Batch No. Specifications reference
Muzaffar 001501 standard and Method of
garh Analysis after 3
reminders.
10. Multan --- --- 22.5.18 Gentamix M/s Breeze No response from firm
injection pharma, to provide Product
100ml Islamabad specification, Method of
Analysis and reference
Batch No. standard after 3
INJ1452 reminders.
INJ1451
INJ1448
INJ1446
INJ1449
INJ1439
INJ1450
11. Rawalpin ------ ----- 22.5.18 Gentamix M/s Breeze No response from firm
di injection pharma, to provide Product
100ml Islamabad specification, Method of
Batch No. standard after 3
INJ1439 reminders.
12. Lahore ------ ------ 21.4.18 Tablet M/s Aventek Method provided by the
Glipten pharma firm did not work by
DTL Lahore.
Batch
No. 085
13. Lahore ------ ------- 10.4.18 Tablet Itsal M/s No response from firm
Batch No. Caraway to provide Product
0007 pharma specification, Method of
standard
DECISION BY PQCB:-
Subject matter was considered by Provincial Quality Control Board, (PQCB) Punjab in
its 186th and 187th meeting held on 15-05-2018 and 31.05.2018 Secretary PQCB appraised the Board
about background of the subject matter which was discussed at length. The Board observed that all the
manufacturers/ drug registration certificate holders are legally bound to provide product specification
and method of analysis to the Government analyst / Drug Testing Laboratories as and when required.
The need for product specification / method of analysis become more critical when the drug is not
available as monograph in official pharmacopoeias & / or the manufacturer has its own customized
specifications / method for analysis. In such circumstances it become quite challenging & / or almost
impossible for a Government Analyst to conduct testing of the drug sample.
1. The Board expressed its serious concerns over casual behavior and non-cooperation by the
above listed firms in this regard. The Board after detailed discussion and deliberation decided
to allow the Provincial Drug Testing Laboratories to file the above-mentioned cases.
Furthermore, the Board decided to recommend the Drug Regulatory Authority of Pakistan
(DRAP) Islamabad for cancellation of registration of the drugs enlisted above, in best public
interest.
a. To advise all manufacturer / importers to provide validated method of analysis and
product specifications to Central Drugs Laboratory, Drug Testing Laboratories and
appellate laboratory within period of 2 months.
b. To issue show cause to above mentioned firms for cancellation of registrations as
recommended PQCB Punjab.
RRR Section
Case No. 48.
A Products deferred in 282nd meeting of Registration Board

Below mentioned were deferred in the 282nd meeting of Registration Board for confirmation of
formulation in reference drug agencies. Accordingly they have been evaluated and placed before the registration
board.
The decision of Registration Board is mentioned below in column VI.
I II III IV V VI
Application
Sr. Initial date of
Reg. No. Product Name receiving Decision
No. Registration
date
i. M/s. Tagma Pharma (Pvt) Ltd., Lahore.
1. 074270 Zasan Tablet 5mg 08/01/2013 Due Date Registration Board acceded the
Each tablet contains 07-01-2018 renewal of product till 07-01-2023
Olanzapine …. 5mg Application as per following:
Received on Zasan Tablet 5mg
05-01-2018 Each coated tablet contains:
Olanzapine …. 5mg
(Innovator Specifications)
2. 074271 Zasan Tablet 10mg 08/01/2013 Due Date Registration Board acceded the
Each tablet contains 07-01-2018 renewal of product till 07-01-2023
Olanzapine …. 10mg Application as per following:
Received on
05-01-2018 Zasan Tablet 10mg
Each coated tablet contains:
Olanzapine …. 10mg
(Innovator Specifications)
ii. Fynk Pharmaceuticals, Lahore.
3. 049012 Caveron Tablet 50mg 27/02/2008 Due Date Registration Board acceded the
Each tablet contains:- 26-02-2018 renewal of product till 26-02-2023
Diclofenac Potassium Application as per following:
… 50mg Received on Caveron Tablet 50mg
(BP) 19-01-2018 Each sugar coated tablet contains:-
Diclofenac Potassium … 50mg
(Innovator Specification)
4. 049014 Feroos Tablet 27/02/2008 Due Date Registration Board acceded the
Ferrous Fumarate … Application as per following:
150mg Received on
Folic Acid … 0.5mg 19-01-2018 Feroos Tablet
(BP) Each coated tablet contains:-
Ferrous Fumarate … 150mg
Folic Acid … 0.5mg
(BP)
5. 49015 Voveron Tablet 50mg 27/02/2008 Due Date Registration Board acceded the
Diclofenac Sodium …. Application as per following:
50mg Received on Voveron Tablet 50mg
(BP) 19-01-2018 Each enteric coated tablet
contains:-
Diclofenac Sodium …. 50mg
(BP)
6. 049016 NO-UL Tablet 40mg 27/02/2008 Due Date Registration Board acceded the
Famotidine …. 40mg Application as per following:
(BP) Received on
19-01-2018 NO-UL Tablet 40mg
Each film coated tablet contains:-
Famotidine …. 40mg
(BP)
7. 049017 Nazdac Tablet 150mg 27/02/2008 Due Date Registration Board acceded the
Ranitidine HCl …. Application as per following:
150mg Received on
(BP) 19-01-2018 Nazdac Tablet 150mg
Each film coated tablet contains:-
Ranitidine HCl eq. to Ranitidine ….
150mg
(BP)
8. 049018 Qilium Tablet 27/02/2008 Due Date Registration Board acceded the
Domperidone …. 10mg Application as per following:
(BP) Received on
19-01-2018 Qilium Tablet
Domperidone maleate eq. to
Domperidone 10mg
(BP)
9. 049019 Paigone Extra Tablet 27/02/2008 Due Date Registration Board deferred the
Each tablet contains:- 26-02-2018 product for submission of
Paracetamol …. 500mg Application pharmacopeial specifications.
Caffeine …. 65mg Received on
(Fynk’s Specs) 19-01-2018
10. 049020 Rox-S Tablet 27/02/2008 Due Date Registration Board acceded the
Each tablet contains:- 26-02-2018 renewal of product till 26-02-2023.
Naproxen (as Sodium) Application
… 500mg Received on
(B.P) 19-01-2018
11. 049022 Leve-Cit Tablet 27/02/2008 Due Date Registration Board acceded the
Each tablet contains:- 26-02-2018 renewal of product till 26-02-2023.
Levocetirizine HCl…. Application
5mg Received on Leve-Cit Tablet
19-01-2018 Each film coated tablet contains:-
Fynk’s Specs Levocetirizine HCl…. 5mg
(Innovator Specs)
12. 049023 Macifar-F Tablet 27/02/2008 Due Date Registration Board acceded the
Iron III Hydroxide Application as per following:
Polymaltose Complex Received on
…. 100mg 19-01-2018 Macifar-F Tablet
Folic Acid...…. 0.35mg Each tablet contains:-
(Fynk Specs) Iron III Hydroxide Polymaltose
Complex …. 100mg
Folic Acid...…. 0.35mg
(Innovator Specs)
13. 049024 Egix Tablet 27/02/2008 Due Date Registration Board deferred the
Each tablet contains:- 26-02-2018 product for submission of
Cetirizine 2HCI …. Application pharmacopeial specifications.
10mg Received on
19-01-2018
Fynk Specs
14. 049025 Becomin Tablet 27/02/2008 Due Date Registration Board acceded the
Mecobalamin …. Application as per following:
500mcg Received on
19-01-2018 Becomin Tablet
Fynk Specs Each sugar coated tablet contains:-
Mecobalamin …. 500mcg
(Japanese Pharmacopeia)
iii. M/s EG Pharmaceuticals. Islamabad.
15. 075130 Neuromin 500mcg 18/01/2013 Due Date Registration Board acceded the
Tablet 17-01-2018 renewal of product till 17-01-2023
Each tablet contains Application as per following:
Mecobalamin …. received on
500mcg 12-01-2018 Neuromin 500mcg Tablet
(EG Specs) Each sugar coated tablet contains
Mecobalamin …. 500mcg
(Japanese Pharmacopeia)
16. 075131 Ficx 400mg Capsule 18/01/2013 Due Date Registration Board acceded the
Each Capsule Contains Change of 17-01-2018 renewal of product till 17-01-2023.
Cefixime as Trihydrate brand name Application
…. 400mg dated 13-12- Received on
USP specs 2017 12-01-2018
17. 075132 Selovef 500mg 18/01/2013 Due Date Registration Board acceded the
Capsule 17-01-2018 renewal of product till 17-01-2023.
Each Capsule Contains Application
Cephradine …. 500mg Received on
(USP) 12-01-2018
18. 075133 Cobix 100mg Capsule 18/01/2013 Due Date Registration Board acceded the
Each Capsule Contains: 17-01-2018 renewal of product till 17-01-2023.
Celecoxib …. 100mg Application
(EG Specs) Received on Cobix 100mg Capsule
12-01-2018 Each Capsule Contains:
Celecoxib …. 100mg
(Innovator Specs)
19. 075135 Tropiset 5mg Injection 18/01/2013 Due Date Registration Board acceded the
Each 5ml contains: 17-01-2018 renewal of product till 17-01-2023
Tropisetrone as HCI Application as per following details:
…. 5mg Received on Tropiset 5mg Injection
(EG Specs) 12-01-2018 Each 5ml contains: Tropisetrone as
HCI …. 5mg
(Innovator Specs)
20. 075137 Doctofer 100mg 18/01/2013 Due Date Registration Board acceded the
Injection 17-01-2018 renewal of product till 17-01-2023
Each 5ml ampoule Application
contains Received on
Iron as Iron Sucrose …. 12-01-2018
100mg
(USP)
21. 075138 Arteg Injection 80mg 18/01/2013 Due Date Registration Board deferred the
Each 1ml ampoule 17-01-2018 product for submission of
contains Application pharmacopeial specifications.
Artemether …. 80mg Received on
(EG Specs) 12-01-2018
22. 075139 Tranex 500mg 18/01/2013 Due Date Registration Board acceded the
Injection 17-01-2018 renewal of product till 17-01-2023.
Each 5ml contains Application
Tranexamic Acid …. Received on
500mg 12-01-2018
(BP Specs)
23. 075140 Axepime 500mg 18/01/2013 Due Date Registration Board acceded the
Each vial contains Application
Cefepime as HCI with Received on
Larginine …. 500mg 12-01-2018
USP Specs
24. 075141 Axepime 1gm 18/01/2013 Due Date Registration Board acceded the
Cefepime as HCI with Received on
Larginine …. 1gm 12-01-2018
USP Specs
25. 075142 Cefabest Injection 18/01/2013 Due Date Registration Board granted renewal
250MG 17-01-2018 of product till 17-01-2023.
Cefotaxime as Sodium Received on
…. 250mg 12-01-2018
USP Specs
26. 075143 Cefabest Injection 18/01/2013 Due Date Registration Board garnted renewal
500mg 17-01-2018 of product till 17-01-2023.
Cefotaxime as Sodium Received on
…. 500mg 12-01-2018
USP Specs
iv. M/s Siza International (Pvt) Ltd Lahore
27. 021846 Megavit Injection 20/05/1998 Due Date Registration Board deferred the
Each 3ml contains:- 19/05/2018 case for clarification from firm
Thiamine HCl … Application regarding their dosage form i.e.
100mg Received on vial/ ampoule as the same is not
Pyridoxine HCl … 22/12/2017 mentioned on the initial registration
100mg letter.
Cyanocobalamine …
1000mcg
28. 030291 Obramycin Injection 20/05/2003 Due Date Registration Board deferred the
20mg 19/05/2018 case for following clarification:
Each ml contains:- Application i. Product is approved as 10mg/ml
Tobramycin (as Received on in 2ml vial in reference agencies
Tobramycin Sulfate) 22/12/2017 (USFDA).
…20mg ii. The dosage form of the product
is also not mentioned on the
(1ml) registration letter whether it is
vial/ ampoule.
iii. Finished product specifications
as the formulation is
pharmacopeial.
iv. Details regarding the last
production batch are not
submitted.
29. 030292 Obramycin Injection 20/05/2003 Due Date Registration Board deferred the
80mg 19/05/2018 case for clarification from firm
Each 2ml contain Application regarding their dosage form i.e.
Tobramycin as Received on vial/ ampoule as the same is not
tobramycin Sulfate …. 22/12/2017 mentioned on the initial registration
80mg letter. Moreover finished product
specifications are also required as
(2ml) the product is pharmacopeial.
30. 030293 Bikil Injection 250mg 20/05/2003 Due Date Registration Board deferred the
Each 2ml contain 19/05/2018 case for following clarification:
Amikacin Sulfate Application
275mg eq. to Amikacin Received on i. Formulation is approved as
…. 250mg 22/12/2017 50mg/ml and 250mg/ml injection
in USFDA and 250mg/ml vial in
(2ml) MHRA.
ii. The dosage form of the
product is not mentioned on the
registration letter whether vial/
ampoule.
iii. Finished product
the product is pharmacopeial.
31. 030294 Bikil Injection 500mg 20/05/2003 Due Date Registration Board deferred the
Each 2ml contain 19/05/2018 case for following clarification:
Amikacin Sulfate Application i. The dosage form of the
550mg eq. to Amikacin Received on product is not mentioned on the
…. 500mg 22/12/2017 registration letter whether vial/
ampoule.
(2ml) ii. Finished product
the product is pharmacopeial.
32. 030297 Sauran 250mg 20/05/2003 Due Date Registration Board granted the
Injection 19/05/2018 renewal till 19-05-2023 as per
Each 2ml contain Application following:
Citicoline …. 250mg Received on Sauran 250mg Injection
22/12/2017 Each 2ml contain
Citicoline …. 250mg
(Innovator Specs)
33. 049114 Ordex Tablet 100mg 25/03/2003 Due Date Registration Board granted the
Each Film coated tablet 24/03/2018 renewal till 24-03-2023 as per
contain Application following:
Cefpodoxime …. Received on
100mg 22/12/2017 Ordex Tablet 100mg
(USP) Each film coated tablet contain
Cefpodoxime proxetil eq. to
Cefpodoxime …. 100mg
(USP)
34. 049115 Kwicef Capsule 500mg 25/03/2003 Due Date Registration Board granted the
Each capsule contain 24/03/2018 renewal till 24-03-2023 as per
Cefadroxil …. 500mg following:
rd th
(USP) Application Kwicef Capsule 500mg
Received on Each capsule contain
22/12/2017 Cefadroxil monohydrate …. 500mg
(USP)
35. 049117 Kwicef Suspension 25/03/2003 Due Date Registration Board granted the
125mg 24/03/2018 renewal till 24-03-2023 as per
Cefadroxil …. 125mg Received on Kwicef Suspension 125mg
(USP) 22/12/2017 Each 5ml contain
Cefadroxil monohydrate…. 125mg
(USP)
36. 049118 Kwicef Suspension 25/03/2003 Due Date Registration Board granted the
250mg 24/03/2018 renewal till 24-03-2023 as per
Cefadroxil …. 250mg Received on Kwicef Suspension 250mg
(USP) 22/12/2017 Each 5ml contain
Cefadroxil monohydrate…. 250mg
(USP)
37. 049119 Solvein I.V Infusion 25/03/2003 Due Date Registration Board deferred the
24/03/2018 case for following:
Each 100ml contain Application
Sodium Lactate …. Received on i. Verification of installation
0.320g 22/12/2017 of TOC analyser and Liquid
Potassium Chloride …. Particle Counter by area FID.
0.040g ii. Latest GMP inspection
Sodium Chloride …. report.
0.600g iii. Clarification for
Calcium Chloride manufacturer specifications
Dihydrate …. 0.027g however the formulation is
water for injection q.s pharmacopeial.
to 100ml
(Siza Specs)
v. M/s Atzan Pharmaceuticals, Sargodha (Veterinary)

38. 049739 Komicoccin Solution 17/09/2008 Due Date Registration Board granted the
Each litre contains 16/09/2018 renewal till 16-09-2023.
Teltrazuril (martindale) Application
…. 25gm Received on
Manufactured by: 10/01/2018
M/s. Komipharm
International Co., Ltd.,
Korea.
vi. M/s Ethical Laboratories (Pvt) Ltd, Lahore
39. 006627 Vesochlor Eye Drops 20/02/1983 Due Date Registration Board granted the
Each 100ml contains 19/02/2018 renewal till 16-09-2023 as per
Chloramphenicol USP Application following:
…. 500mg Received on Vesochlor Eye Drops
08/02/2018 Each 100ml contains
Chloramphenicol USP …. 500mg
(USP)
vii. M/s Intervac (Pvt) Ltd, Lahore (Veterinary Products)
40. 046676 K-Fas Powder 17-01-2008 Due Date Registration Board granted renewal
Each 100gm contains 16/01/2018 till 16-01-2023.
Menadion Sodium Application
Bisulfite (Vit K-3) …. Received on
12.5gm 01/01/2018
41. 046677 Biocol-TD Powder 17-01-2008 Due Date Registration Board granted renewal
Tylosin Tartrate …. Application
10gm Doxycycline Received on
HCI …. 20gm 01/01/2018
Bromhexine …. 10gm
Colistin Sulphate ….
3gm
42. 046678 Lincofas-44 Powder 17-01-2008 Due Date Registration Board granted renewal
Each Kg contains 16/01/2018 till 16-01-2023.
Lincomycin HCI …. Application
4.4GM Received on
01/01/2018
43. 046679 Biofas CRD W.S.P 17-01-2008 Due Date Registration Board granted renewal
Spiramycin Adipate Application
Vet ….. 8,000,000 I.U Received on
Oxytetracyline HCI 01/01/2018
…. 6000mg
Bromhexine HCI ….
150mg
44. 046680 Enrodine Oral Solution 17-01-2008 Due Date Registration Board granted renewal
Each 100ml contains 16/01/2018 till 16-01-2023.
Enrofloxacin HCI …. Application
10gm Amantadine Received on
HCI …. 4gm 01/01/2018
45. 046681 Enrofas 20% Oral 17-01-2008 Due Date Registration Board granted renewal
Solution 16/01/2018 till 16-01-2023.
Enrofloxacin …. 20gm Received on
01/01/2018
46. 046682 Tylodox-C Powder 17-01-2008 Due Date Registration Board granted renewal
Tylosin Tartrate …. Application
140gm Doxycycline Received on
HCI …. 160gm 01/01/2018
Colistin Sulphate ….
1200 M.I.U
47. 046883 Amidiofas Powder 17-01-2008 Due Date Registration Board granted renewal
Amprolium HCI …. Application
20gm Received on
Furaltadone HCI …. 01/01/2018
20gm
48. 046884 Vita Tox Powder 17-01-2008 Due Date Registration Board granted renewal
Vitamin A …. Application
10000000 I.U Received on
Vitamin E …. 2500mg 01/01/2018
Vitamin K-3 ….
1000mg
Vitamin C …. 2500mg
Sodium Benzoate…
500gm
Ethanol beta-amino
Phosphoric acid ….
100gm
viii. M/s Zanctok Pharmaceuticals, Hyderabad
49. 029762 Painogin Tablet 50mg 05/03/2003 Due Date Registration Board granted the
Each tablet contains 04/03/2018 renewal till 04-03-2023 as per
Diclofenac Potassium Application following:
…. 50mg Received on Painogin Tablet 50mg
09/02/2018 Each sugar coated tablet contains
Diclofenac Potassium …. 50mg
(Innovator Specs)
50. 029763 Rancidine Tablet 05/03/2003 Due Date Registration Board deferred the
150mg 04/03/2018 product for submission of
Each tablet contains Application pharmacopeial specifications.
Ranitidine as HCI …. Received on
150mg 09/02/2018
ix. M/s Espoir Pharmaceuticals, Karachi
51. 073783 Ainis 100mg Tablet 30/01/2013 Due Date Deferred for submission of copy of
Each tablet contain 29/01/2018 BP monograph for finished
Aceclofenac as Sodium Application product specs.
…. 100mg Received on
(BP Specifications) 28/12/2017
52. 073782 Haito 10mg Tablet 30/01/2013 Due Date Registration Board granted renewal
Each tablet contain 29/01/2018 till 29-01-2023.
Domperidone maleate Application
eq. to Domperidone …. Received on
10mg 28/12/2017
(BP Specifications)
53. 073784 Pulsar 100mg Capsule 30/01/2013
Due Date Registration Board granted renewal
Each capsule contain 29/01/2018 till 29-01-2023.
Gabapentin …. 100mg Application
(USP Specification) Received on
28/12/2017
54. 073785 Pulsar 300mg Capsule 30/01/2013 Due Date Registration Board granted renewal
Each capsule contain 29/01/2018 till 29-01-2023.
Gabapentin …. 300mg Application
(USP Specification) Received on
28/12/2017
x. M/s Bryon Pharmaceuticals Pvt Limited, Peshawar
55. 029994 Zeclorin 250mg Tablet 01/04/2003 Due Date Registration Board deferred the
Each tablet contains 31/03/2018 product for submission of
Clarithromycin …. Application pharmacopeial specifications.
250mg Received on
23/02/2018
56. 029995 Nobillium 1mg Tablet 01/04/2003 Due Date Registration Board deferred the
Each tablet contains Change of 31/03/2018 product for submission of
Risperidone …. 1mg Brand Name Application pharmacopeial specifications.
28/07/2005 Received on
23/02/2018
Risperidone …. 2mg Brand Name pharmacopeial specifications.
28/07/2005 Application
Received on
23/02/2018
Risperidone …. 3mg Brand Name Application pharmacopeial specifications.
28/07/2005 Received on
23/02/2018
59. 049091 Alben Suspension 18/03/2008 Due Date Registration Board granted renewal
200mg 17/03/2018 till 17-03-2023.
Albendazole …200mg Received on
(USP) 23/02/2018
60. 049092 Flectin Syrup 20mg 18/03/2008 Due Date Registration Board granted renewal
Each 5ml contains 17/03/2018 till 17-03-2023.
Fluoxetine HCI... 20mg Application
(USP) Received on
23/02/2018
61. 049093 Gynosafe Vaginal 18/03/2008 Due Date Registration Board granted renewal
Cream 17/03/2018 till 17-03-2023.
Each tube contains Application
Clotrimazole …. 10% Received on
(USP) 23/02/2018
62. 049094 Cobvit Tablet 18/03/2008 Due Date Registration Board granted renewal
Each tablet contains 17/03/2018 till 17-03-2023 as per following:
Mecobalamin… Application Cobvit Tablet
500mcg Received on Each sugar coated tablet contains
(Bryon Specs) 23/02/2018 Mecobalamin… 500mcg
(JP Specs))
63. 049096 Tagozer Tablet 30mg 20/03/2008 Due Date Registration Board granted renewal
Pioglitazone as HCI …. Application
30mg Received on Tagozer Tablet 30mg
(Bryon Specs) 23/02/2018 Each tablet contains
Pioglitazone as HCI …. 30mg
(Innovator Specs)
(Bryon Specs) 23/02/2018 Each tablet contains
(Innovator Specs)
23/02/2018 Each tablet contains
(Innovator Specs)
66. 049154 Sopral Plus 5mg Tablet 11-04-2008 Due Date Registration Board deferred the
Bisoprolol Fumarate Application pharmacopeial specifications.
….5mg Received on
23/02/2018
Hydrochlorothiazide
…. 6.25mg
(Bryon Specs)
xi. Unison Chemical Works, Lahore
67. 029701 Macdafin Tablet 21-03-2003 Due Date Deferred for following:
Each tablet contains 20/03/2018 i. Finished product
Diclofenac Sodium …. Application specifications.
50mg Received on ii. Description of tablet.
09/02/2018
68. 029703 GD-Cid Tablet 12-03-2003 Due Date Deferred for following:
Famotidine …. 40mg Application specifications.
Received on ii. Description of tablet.
09/02/2018
69. 029704 Fai-Cam Dispersible 12-03-2003 Due Date Registration Board granted the
Tablet 11/03/2018 renewal till 11-03-2023 as per
Each tablet contains Application following:
Piroxicam …. 20mg Received on Fai-Cam Dispersible Tablet
09/02/2018 Each tablet contains
Piroxicam …. 20mg
(Innovator Specs)
70. 030065 Dinopen 50 Tablet 12-03-2003 Due Date Registration board granted renewal
Diclofenac Application Dinopen 50 Tablet
Potassium…. 50mg Received on Each sugar coated tablet contains
09/02/2018 Diclofenac Potassium…. 50mg
(Innovator Specs)
71. 030066 Hirazine Tablet 12-03-2003 Due Date Deferred for following:
Cetirizine 2HCI …. Application specifications.
10mg Received on ii. Description of tablet.
09/02/2018
xii. M/s Pakistan Pharmaceutical Products (Pvt) Ltd., Karachi.
72. 009318 Ulcedine Syrup 16/1/1993 Due Date Registration Board deferred the
200mg/5ml 15/01/2018 product for submission of
Each 5ml contains Application pharmacopeial specifications.
Cimetidine …. 200mg Received on
05/01/2018
73. 013900 Famdin Tab 16/1/1993 Due Date Registration Board deferred the
Each film coated tablet 15/01/2018 product for submission of
contains Application pharmacopeial specifications.
Famotidine …. 40mg Received on
05/01/2018
74. 009450 Rifapee Tablet 16/1/1993 Due Date Registration Board deferred the
Rifampicin …. 450mg Application pharmacopeial specifications.
Received on
05/01/2018
75. 009301 Rifapee Suspension 16/1/1993 Due Date Registration Board deferred the
Each 5ml contains 15/01/2018 product for submission of
Rifampicin …. 100mg Application pharmacopeial specifications.
Received on
05/01/2018
xiii. M/s Standpharm Pakistan (Pvt) Ltd., Lahore.
76. 020950 Motaar SR Tablet 25/02/1998 Due Date Deferred for clarification of
100mg 24/02/2018 following:
Each tablet contains Application i. Description of tablet.
Diclofenac Sodium …. Received on ii. Pharmacopeial specifications.
100mg 15/01/2018
77. 020951 Lorel Syrup 25/02/1998 Due Date Registration Board deferred the
Each 5ml contains 24/02/2018 product for submission of
Loratadine …. 5mg Application pharmacopeial specifications.
Received on
15/01/2018
78. 020953 Dopnil Tablet 25/02/1998 Due Date Deferred for clarification of
Each tablet contains 24/02/2018 following:
Cetirizine …. 10mg Application i. Description of tablet.
Received on ii. Pharmacopeial specifications.
15/01/2018 iii. Label claim as per salt form.
79. 020956 Resque Capsule 25/02/1998 Due Date Deferred for clarification of
Each Capsule Contains 24/02/2018 following:
Azithromycin …. Application i. Pharmacopeial specifications.
250mg Received on ii. Label claim as per salt form.
15/01/2018
80. 020957 Resque Dry Suspension 25/02/1998 Due Date Deferred for clarification of
Each 5ml contains 24/02/2018 following:
Azithromycin …. Application i. Pharmacopeial specifications.
200mg Received on ii. Label claim as per salt form.
15/01/2018
81. 074296 Dopez 10mg Tablet 11/02/2013 Due Date Deferred for clarification of
Each tablet contains 10/02/2018 following:
Donepezil HCl …10mg Application i. Description of tablet.
Received on ii. Pharmacopeial specifications.
(Standpharm Specs) 15/01/2018
82. 074300 Zuphen Injection 50mg 11/02/2013 Due Date Deferred for following:
Each 1ml contains 10/02/2018 i. Pharmacopeial specifications
Zuclopenthixol Acetate Application ii. Dosage form of the product is not
…. 50mg Received on mentioned in the initial letter
(Standpharm Specs) 15/01/2018 whether vial/ ampoule.
xiv. M/s Nawan Laboratories (Pvt) Ltd., Lahore. (Veterinary Products)
83. 1 020804 Colimox Injection 20/01/1998 Due Date Registration Board granted renewal
Each 100ml contain 19/01/2018 till 19-01-2023.
Amoxicillin trihydrate Application
eq. to Amoxicillin …. Received on
10gm 18/12/2017
Colistin as Colistin Differential
sulphate …. 25 M.I.U. fee of year
2013 of
Rs10,000
received on
19-03-18
84. 020803 Encure-10 Injection 20/01/1998 Due Date Registration Board granted renewal
Enrofloxacin …. 10gm Application
Received on
18/12/2017
Differential
fee of year
2013 of
Rs10,000
received on
19-03-18
85. 020799 Encure-20 Solution 20/01/1998 Due Date Registration Board granted renewal
Enrofloxacin …. 20gm Application
Received on
18/12/2017
Differential
fee of year
2013 of
Rs10,000
received on
19-03-18
86. 020802 Wormec Injection 20/01/1998 Due Date Registration Board granted renewal
Ivermectin …. 1gm Application
Received on
18/12/2017
Differential
fee of year
2013 of
Rs10,000
received on
19-03-18
87. 020801 Trimodin -48 Injection 20/01/1998 Due Date Registration Board granted renewal
Trimethoprim …. 8gm Application
Sulphadiazine …. Received on
40gm 18/12/2017
Differential
fee of year
2013 of
Rs.10,000
received on
19-03-18
88. 020800 Nawacin LA Injection 20/01/1998 Due Date Registration Board granted renewal
Oxytetracycline Application
Dihydrate eq. to 20gm Received on
Oxytetracycline base 18/12/2017
Differential
fee of year
2013 of
Rs10,000
received on
19-03-18
xv. M/s PharmEvo (Private) Ltd., Karachi
89. 073761 Olsarb-A 5/20 Tablet 24/01/2013 Due Date Registration Board granted renewal
Amlodipine as besylate 23/01/2018 till 23-01-2023 with Innovator
…. 5mg Application Specifications.
Olmesartan medoxomil Received on
…. 20mg 16/01/2018
(Manufacturer Specs)
90. 073762 Telsarta-A 5/80mg 24/01/2013 Due Date Registration Board granted renewal
Tablet 23/01/2018 till 23-01-2023 with Innovator
Each tablet contains Application Specifications.
Amlodipine as Besylate Received on
…. 5mg 16/01/2018
Telmisartan …. 80mg
…. 5mg 16/01/2018
92. 073764 Olsarb-D 20/12.5mg 24/01/2013 Due Date Registration Board granted renewal
Olmesartan Medoxomil Received on
…. 20mg 16/01/2018
Hydrochlorothiazide
…. 12.5mg
93. 073765 Olsarb-A 5/40mg 24/01/2013 Due Date Registration Board granted renewal
…. 5mg 16/01/2018
Olmesartan medoxomil
…. 40mg
94. 073766 Olsarb-D 40/12.5mg 24/01/2013 Due Date Registration Board granted renewal
Olmesartan Medoxomil Received on
…. 40mg 16/01/2018
Hydrochlorothiazide
…. 12.5mg
…. 10mg 16/01/2018
…. 10mg 16/01/2018
97. 073769 Arbi 150mg Tablet 24/01/2013 Due Date Registration Board granted renewal
Each tablet contains 23/01/2018 till 23-01-2023.
Irbesartan …. 150mg Application
(USP Specs) Received on
rd
556
16/01/2018
98. 073770 Arbi 300mg Tablet 24/01/2013 Due Date Registration Board granted renewal
Each tablet contains 23/01/2018 till 23-01-2023.
Irbesartan …. 300mg Application
(USP Specs) Received on
16/01/2018
99. 073771
Arbi-D 300/12.5mg 24/01/2013 Due Date Registration Board granted renewal
Tablet 23/01/2018 till 23-01-2023.
Each tablet contains Application
Irbesartan …. 300mg Received on
Hydrochlorothiazide 16/01/2018
…. 12.5mg
(USP Specs)
100. 073772 Arbi-D 150/12.5mg 24/01/2013 Due Date Registration Board granted renewal
Tablet 23/01/2018 till 23-01-2023.
Each tablet contain Application
Irbesartan …. 150mg Received on
Hydrochlorothiazide 16/01/2018
…. 12.5mg
(USP Specs)
xvi. M/s Opal Laboratories (Pvt) Ltd, Karachi.
101. 073705 Perc Tablet 23/01/2013 Due Date Registration Board deferred the
Each tablet contain Change of 22/01/2018 product for submission of
Betahistine brand name Application pharmacopeial specifications.
Dihdrochloride …. 04/04/2013 Received on
16mg 04/12/2017
102. 073707 Damor 50mg Tablet 23/01/2013 Due Date Registration Board granted renewal
Each tablet contain 22/01/2018 till 22-01-2023 with Innovator
Tramadol HCI….50mg Application Specifications.
(Manufacturer Specs) Received on
04/12/2017
103. 073708 Malther DS Dry 23/01/2013 Due Date Registration Board deferred the
Suspension 22/01/2018 product for submission of
Each 5ml contain Application pharmacopeial specifications.
Artemether …. 30mg Received on
Lumefantrine 04/12/2017
….180mg
xvii. M/s Saturn Pharmaceutical (Pvt) Ltd., Lahore.
104. 074229 Vitamin D3 Injection 24/12/2012 Due Date Registration Board granted renewal
Each ml contains 23/12/2017 till 23-12-2022.
Vitamin D3 Application
(Cholecalciferol) …. Received after
200,000 I.U. expiry of
(5mcg/ml (200000IU) Registration
(BP Specs) but within 60
days i.e. on
01/02/2018
with
prescribed fee
of Rs.20,000/-
xviii. M/s Macter International Limited, Karachi.
105. 073632 Tacip 4.5gm Injection 03/01/2013 Due Date Deferred for clarification regarding
Each vial contains 02/01/2018 manufacturing facility for
Piperacillin as Sodium Application penicillin.
Tazobactum as Sodium 02/01/2018
…. 500mg
106. 073631 Tacip 3.37gm Injection 03/01/2013 Due Date Registration Board deferred the
Each vial contains 02/01/2018 product for submission of
Piperacillin as Sodium Application pharmacopeial specifications.
Tazobactum as Sodium 02/01/2018
…. 375mg
107. 003253 Paramac 120mg 04/01/1978 Due Date Registration Board deferred the
Suspension 03/01/2018 product for submission of
Each 5ml contains Application pharmacopeial specifications.
Paracetamol …. 120mg Received on
02/01/2018
108. 013856 Ciproquine Tablet 26/01/1993 Due Date Registration Board deferred the
Ciprofloxacin as HCI Application pharmacopeial specifications.
02/01/2018
109. 013855 Oflamac Tablet 26/01/1993 Due Date Registration Board deferred the
Ofloxacin …. 200mg Application pharmacopeial specifications.
Received on
02/01/2018
110. 013854 Co-Amoxi Suspension 26/01/1993 Due Date Deferred for clarification regarding
156.25mg 25/01/2018 manufacturing facility for
Each 5ml contains Application penicillin.
Amoxicillin Trihydrate Received on
eq. to 02/01/2018
125mgAmoxycillin
base.
Clavulanic acid as
Potassium Salt ….
31.25mg
111. 013853 Co-Amoxi Tablet 26/01/1993 Due Date Deferred for clarification regarding
375mg 25/01/2018 manufacturing facility for
Each tablet contains Application penicillin.
Amoxicillin Trihydrate Received on
eq. to 250mg 02/01/2018
Amoxicillin base.
Clavulanic acid as
Potassium Salt ….
125mg
112. 013849 Bismol Suspension 26/01/1993 Due Date Registration Board granted renewal
88mg 25/01/2018 till 25-01-2023 with Innovator
Each 5ml contains Application specifications.
Bismuth sub-salicylate Received on
…. 88mg 02/01/2018
113. 073710 Clatica 3.5gm Injection 23/01/2013 Due Date Deferred for clarification regarding
Each vial contains 22/01/2018 manufacturing facility for
penicillin.
Ticarcillin as disodium Application
Clavulanic acid as 02/01/2018
Potassium Salt ….
200mg
xix. M/s Danas Pharmaceuticals (Pvt) Limited, Islamabad.
114. 075205 Norden Tablet 20/02/2013 Due Date Registration Board granted renewal
Each tablet contains Change of 19/02/2018 till 19-2-2023 with Innovator
Paracetamol …. 450mg Brand Name Application specifications.
Orphenadrine Citrate 20/09/2013 Received on
…. 35mg 19/02/2018
B. Formulations not approved in reference regulatory authorities.

I II III IV V VI
Sr. Initial date of Application
Reg. No. Product Name Decision
No. Registration receiving date
i. Fynk Pharmaceuticals, Lahore.
1. 049013 Caveron Tablet 75mg 27/2/2008 Due Date Strength is not approved in
Each tablet contains:- 26-02-2018 reference drug agencies.
Diclofenac Potassium Application Formulation is not available in BP,
… 75mg Received on however the registration letter was
(BP) 19-01-2018 issued with BP specs.
2. 049021 FYNKARD Tablet 27/2/2008 Due Date Formulation is not approved in
Each tablet contains:- 26-02-2018 reference drug agencies.
Metoprolol …. 25mg Application
(BP) Received on
19-01-2018
ii. M/s EG Pharmaceuticals. Islamabad.
3. 075134 Tropiset 5mg Capsule 18/1/2013 Due Date Product is not available in any of
Each Capsule Contains: 17-01-2018 reference regulatory agencies.
Tropisetrone as HCI Application
(EG Specs) 12-01-2018
4. 075136 Xtramol Injection 18/1/2013 Due Date Product is not available in any of
Each 2ml ampoule 17-01-2018 reference regulatory agencies.
contains Application
Paracetamol …. 300mg Received on
Lidocaine HCI…20mg 12-01-2018
(EG Specs)
iii. M/s Siza International (Pvt) Ltd Lahore
5. 030295 Bikil Injection 20/05/2003 Due Date Formulation is not approved in
1000mg 19/05/2018 reference drug agencies.
Each 2ml contain Application The dosage form of the product is
Amikacin Sulfate Received on not mentioned on the registration
1100mg eq. to 22/12/2017 letter whether vial/ ampoule.
Amikacin …. 1000mg The product is pharmacopeial,
therefore reference may be
incorporated in the renewal letter.
6. 030296 Sauran 1000mg 20/05/2003 Due Date Formulation in instant strength is
Injection 19/05/2018 not approved in any of the
Each 4ml contain Application reference drug agencies.
Citicoline …. 1000mg Received on
22/12/2017
7. 049116 Kwicef Capsule 25/03/2003 Due Date Formulation in the instant strength
1000mg 24/03/2018 is not approved in any of the
Each capsule contain Application reference drug agencies.
Cefadroxil …. 1000mg Received on
(USP) 22/12/2017
8. 049120 Cefvox Dry Suspension 25/03/2003 Due Date Formulation in the instant strength
Each 5ml contain 24/03/2018 is not approved in any of the
Cefdinir …. 50mg Application reference drug agencies.
(Siza Specs) Received on Moreover the product is
22/12/2017 pharmacopeial (USP) but on the
registration letter manufacturer
specs are mentioned.
9. 049121 Cefvox Capsule 100mg 25/03/2003 Due Date Formulation in the instant strength
Each capsule contain 24/03/2018 is not approved in any of the
Cefdinir …. 100mg Application reference drug agencies.
(Siza Specs) Received on Moreover the product is
22/12/2017 pharmacopeial (USP) but on the
registration letter manufacturer
specs are mentioned.
iv. M/s Ethical Laboratories (Pvt) Ltd, Lahore
10. 006629 Doxachlor Eye Drops 20/02/1983 Due Date Formulation is not found in
0.5% 19/02/2018 reference drug agencies.
Chloramphenicol …. Received on
0.5gm 08/02/2018
Dexamethasone
Sodium Phosphate ….
0.1gm
11. 006628 Chloramphenicol Ear 20/2/1983 Due Date Formulation is not found in
Drops 19/02/2018 reference drug agencies.
Each 100ml contains Application Last batch was manufactured on
Chloramphenicol Levo Received on 25-11-2009
USP …. 1gm 08/02/2018
v. M/s Zanctok Pharmaceuticals, Hyderabad
12. 016723 Zeohydramine Cough 11/02/1998 Due Date
Syrup 10/02/2018
Ammonium Chloride Received on
…. 100mg 09/02/2018
Ephedrine HCI …. 7mg
Diphenhydramine HCI
…. 8mg
vi. M/s Bryon Pharmaceuticals Pvt Limited, Peshawar
13. 049090 Minacid Suspension 18/03/2008 Due Date Evidence of approval of
50mg 17/03/2018 formulation in reference agencies
Each 5ml contains Application is required.
Mefenamic Acid …. Received on
50mg 23/02/2018
(B.P)
14. 075576 Azibect 500 Capsule 26-03-2013 Due Date Formulation is not available in
Each Capsule Contains 25/03/2018 reference drug agencies.
Azithromycin …. Application
500mg Received on
(Bryon Specs) 23/02/2018
vii. Unison Chemical Works, Lahore
15. 029702 Unicough Syrup 12-03-2003 Due Date
Each 5ml contains 11/03/2018
Ammonium Chloride Application
…. 100mg Sodium Received on
Citrate …. 58mg 09/02/2018
Chlorpheniramine
Maleate …. 2mg
Menthol …. 1mg
viii. M/s Standpharm Pakistan (Pvt) Ltd., Lahore.
16. 020955 Curitol Infusion 25/02/1998 Due Date Formulation is not approved in
Each 100ml contain 24/02/2018 reference drug agencies.
Ofloxacin HCI …. Application Approved Formulation is Taravid
220mg Received on (Ofloxacin 2mg/ml 100ml
15/01/2018 infusion)
17. 074297 Mintride 2 Tablet 11/02/2013 Due Date Formulation is not approved in
Each tablet contains 10/02/2018 reference drug agencies
Metformin as HCI …. Application
500mg Received on
Glimepiride …. 2mg 15/01/2018
(Standpharm Specs)
18. 074298 Mintride 1 Tablet 11/02/2013 Due Date Formulation is not approved in
Each tablet contains 10/02/2018 reference drug agencies.
Metformin as HCI …. Application
500mg Received on
Glimepiride …. 1mg 15/01/2018
(Standpharm Specs)
19. 074299 Zuphen Injection 11/02/2013 Due Date Formulation is approved in
200mg 10/02/2018 reference agency (MHRA) as
Each 1ml contains Application Zuclopenthixol
Zuclopenthixol Received on decanoate 200mg/ ml injection in
Acetate …. 200mg 15/01/2018 thin vegetable oil.
ix. M/s Opal Laboratories (Pvt) Ltd, Karachi.
20. 073706 Prosec70mg/30ml 23/01/2013 Due Date Formulation is not available in
Suspension 22/01/2018 reference drug agencies.
Each 30ml contain Application
Secnidazole …. 750mg Received on
(Manufacturer Specs) 04/12/2017
21. 073709 Draza 40mg Tablet 23/01/2013 Due Date Formulation is not available in
Each tablet contain 22/01/2018 reference drug agencies.
Drotaverine HCI …. Application
40mg Received on
(Manufacturer Specs) 04/12/2017
x. M/s Saturn Pharmaceutical (Pvt) Ltd., Lahore.
22. 074228 Cynosat Injection 24/12/2012 Due Date Formulation is approved in
Each ml contains 23/12/2017 reference agencies as 1mg/ml.
Cyanocobalamine …. Application Formulation is pharmacopeial
500mcg Received after
(Saturn Spec’s) expiry of
Registration but
within 60 days
i.e. on
01/02/2018 with
prescribed fee
of Rs.20,000/-
23. 074230 Lignocaine Injection 24/12/2012 Due Date Formulation is not approved in
Each vial contains 23/12/2017 reference drug agencies.
Lignocaine HCI …. 2% Application
Adrenaline …. Received after
1:80,000 expiry of
(Saturn Specs) Registration but
within 60 days
i.e. on
01/02/2018 with
prescribed fee
of Rs.20,000/-
24. 074231 Arisat Injection 24/12/2012 Due Date Formulation is not approved in
Each 2ml contains 23/12/2017 reference drug agencies
Pheniramine Maleate Application
…. 25mg Received after
expiry of
Registration but
within 60 days
i.e. on
01/02/2018 with
prescribed fee
of Rs.20,000/-
xi. M/s Macter International Limited, Karachi
25. 073704 Adalin Sugar Free 11/01/2013 Due Date
Syrup 10/01/2018
Each 5ml contains: Application
Aminophylline …. Received on
32mg 02/01/2018
Diphenhydramine HCI
…. 8mg
Ammonium Chloride
…. 30mg
Menthol …. 0.98mg
26. 003260 Dimeco Suspension 04/01/1978 Due Date Strength of ingredients varies with
Each 5ml contains 03/01/2018 the formulation approved in
Aluminum Hydroxide Application reference agencies (Maalox Plus
Gel … 215mg Received on Suspension MHRA)
Magnesium Hydroxide 02/01/2018 Composition is not mentioned in
… 80mg the initial letter. The same is
Simethicone … 25mg written as provided by the firm in
Form-5B
27. 003249 Digel Suspension 04/01/1978 Due Date Strength of ingredients varies with
Each 5ml contains 03/01/2018 the formulation approved in
Aluminum Hydroxide Application reference agencies (Maalox Plus
Gel…. 5.19mg Received on Suspension MHRA)
Magnesium Hydroxide 02/01/2018 Composition is not mentioned in
…. 85mg the initial letter. The same is
written as provided by the firm in
Form-5B
28. 013846 Bismol Tablet 265mg 26/01/1993 Due Date Strength of ingredients varies with
Each tablet contains 25/01/2018 the formulation approved in
reference agencies.
rd th
Bismuth sub-salicylate Application Moreover the dosage form is
…. 265mg Received on approved as chewable tablet.
02/01/2018
29. 073710 Clatica 3.5gm Injection 23/01/2013 Due Date Deferred for clarification
Each vial contains 22/01/2018 regarding manufacturing facility
Ticarcillin as disodium Application for penicillin.
Clavulanic acid as 02/01/2018
Potassium Salt ….
200mg
xii. Danas Pharmaceuticals (Pvt) Ltd., Islamabad.
30. 075206 Iwill Injection 20/2/2013 Due Date Formulation is not approved in any
Each ml contains 19/02/2018 of the reference agencies.
Pheniramine Maleate Application
…. 22.7mg Received on
19/02/2018
Decision: Registration Board deferred for further deliberations.
Case No. 49: Renewal applications of finished imported drugs (human) evaluated as per SOP approved
by Registration Board.
Sr. Reg. No. Brand Name, Manufactu Initial

Date of Renewal Remarks (if any)
No Composition rer date of
applicati validity
& Registrat
on (R&I)
Specification ion Fee
submitte
d
i. M/s OBS Healthcare (Pvt) Limited, 91 Shahrah-e-Iran Block 5 Clifton Karachi
1. 033185 Exluton 0.5mg M/s N.V. 12-04- Dy. No. 12-4-2023 The firm was advised on
Tablet Organon, 2008 5223 25-5-2018 vide letter No.
Each tablet Kloosterstr dated 13- 1-2/2017-RRR to
contains: aat 6, 5349 2-2018 provide the DRAP
Lynestrenol … AB Oss, attested invoice of last
0.5mg The 20000/- import, however the firm
Netherland informed that Exluton
s tablets are directly
imported by
Government of Pakistan
for tenders and Govt.
supplies.
Moreover the complete
address of the
manufacturer as
mentioned in CoPP
provided by the firm may
be incorporated in the
renewal letter, which is
not mentioned in the
initial registration letter.
Decision: Registration Board granted the renewal of above product till 11-04-2023 as per the
manufacturing address mentioned in CoPP i.e. M/s N.V. Organon, Kloosterstraat 6, 5349
AB Oss, The Netherlands.
Case No. 50 Renewal applications of local manufacturers (human) evaluated as per SOP approved by
Registration Board.
Sr. Reg. No. Brand Name, Initial date Date of Renewal Decision
No Composition & of application validity
Specification Registration (R&I)
Fee
submitted
i. M/s Epla Laboratories (Pvt) Limited D-12 Estate Avenue S.I.T.E Karachi
2. 030589 Mecol 500mg 29-4-2003 5836 dated 29-04-2023 Registration Board granted
Tablet 16-2-2018 the renewal till 28-04-2023
as per following:
Each tablet 10000/-
contains: Mecol 500mg Tablet
Mecobalamin…..50
0mcg Each sugar coated tablet
contains:
Mecobalamin…..500mcg
(JP Specification)
3. 021201 Prescard-5 Tablet 28-4-1998 5836 dated 28-4-2018 Registration Board granted
Each tablet 16-2-2018 the renewal till 27-04-2023
contains: as per following:
Amlodipine ( as 10000/- Prescard-5 Tablet
Amlodipine Each film coated tablet
besylate)…..5mg contains:
Amlodipine ( as Amlodipine
besylate)…..5mg
(Innovator Specification)
ii. M/s Welmark Pharmaceuticals, Plot No. 122 Block B, Phase V, Industrial Estate Hattar, District
Haripur.
4. 049032 Elzed 40mg 01-03-2008 Dy. No. 01-03-2023 Registration Board granted
Injection 7507 dated the renewal till 28-02-2023
27-02-2018 with Innovator
Each vial contains: specifications.
Omeprazole 10000/-
sodium….40mg
(Welmark Specs) Change o0f
name dated
17-2-2011
5. 049033 Brince 40mg 01-03-2008 Dy. No. 01-03-2023 Registration Board granted
Injection 7507 dated the renewal till 28-02-2023
27-02-2018 with Innovator
Each vial contains: specifications.
Esomeprazole 10000/-
sodium eq. to
Esomeprazole…40 Change of
mg brand name
(Welmark Specs) dated 21-12-
2015
Case No. 51 Typographical Errors of 277th Meeting

Sr. Reg. Date of Decision of the Typographical
Firm Name Brand Name
No. No. Reg. Board Error
1. M/s. Himont 016682 Cardil 5mg Tablet 13-10-1996 Registration Board Composition of the
Pharmaceuti Each tablet acceded to request of product is corrected
cals (Pvt) contains:- the firms and decided as Enalapril
Ltd., Lahore. Ezitimibe … 10mg to grant/regularize Maleate… 5.0mg
Simvastatin …20mg the renewal till 17-
08-2022.
2. M/. Brookes 058193 Osocyte 5 mg Tablet 11-04-2009 Registration Board Registration date is
Pharma (Pvt) Each tablet acceded to request of corrected as 11-08-
Ltd., contains:- the firms and decided 2009 and validity
Karachi. Risedronate Sodium to grant/regularize will be 10-08-2019
… 5mg the renewal till 10-
04-2019.
3. M/. Brookes 058194 Osocyte 35mg 11-04-2009 Registration Board Registration date is
Pharma (Pvt) Tablet acceded to request of corrected as 11-08-
Ltd., Each tablet the firms and decided 2009, accordingly
Karachi. contains:- to grant/regularize validity will be
Risedronate Sodium the renewal till 10- given as
… 35mg 04-2019. 10-08-2019
4. M/. Brookes 058195 Sycorid 1mg Tablet 11-04-2009 Do Do
Pharma (Pvt) Each tablet
Ltd., contains:-
Karachi. Risperidone … 1mg
Ltd., contains:-
Ltd., contains:-
Ltd., contains:-
8. M/s. 060858 Mocan DS Capsules 24-01-2009 Registration Board Registration Date is
Ambrosia Each capsule acceded to request of corrected as 17-10-
Pharmaceuti contains:- the firms and decided 2009 ,accordingly
cals, Artemether … 40mg to grant/regularize validity will be
Karachi. Lumefantrine … the renewal till 23- given as 16-10-
240mg 01-2019. 2019
9. M/s Hilton 029075 Rezclam Tablets 08-01-2003 Registration of the Brand name is
Pharma Each tablet drug is renewed corrected as
(Pvt.) Ltd., contains:- w.e.f. 08-01-2018 to Rezcalm.
Karachi. 07-01-2023.
Risperidone … 1mg
10. M/s Hilton 029076 Rezclam Tablets Do Do Do
Pharma Each tablet
(Pvt.) Ltd., contains:-
11. M/s Hilton 029077 Rezclam Tablets Do Do Do
Pharma Each tablet
(Pvt.) Ltd., contains:-
12. M/s Hilton 029078 Co-Zinocard Tablets Do Do Composition is
Pharma Each tablet corrected as
(Pvt.) Ltd., contains:- Lisinopril as
Karachi. Lisinopril … 20mg dihydarate … 20mg
Hydrochlorthiazide Hydrochlorothiazid
… 12.5mg e … 12.5mg
13. M/s Hilton 029708 Cefrac Suspension 19-03-2003 Registration of the Composition is
Pharma Each 5ml contains:- drug is renewed corrected as
(Pvt.) Ltd., Cefpodoxime … w.e.f. 19-03-2018 to Cefpodoxime
18-03-2023. proxetile eq. to
Karachi. 40mg
Cefpodoxime base
… 40mg
14. M/s Hilton 029709 Cefrac Tablet Do Do Composition is
Pharma Each tablet corrected as
(Pvt.) Ltd., contains:- Cefpodoxime
Karachi. Cefpodoxime … proxetile eq. to
100mg
Cefpodoxime base
… 100mg
15. M/s Hilton 047376 Ronirole 0.25mg 02-01-2008 Registration of the Brand name is
Pharma Tablets drug is renewed corrected as Ronirol
(Pvt.) Ltd., Each tablet w.e.f. 02-01-2018 to and composition as
01-01-2023. Ropinirole
Karachi. contains:-
Hydrochloride eq.
Ropinirole … to Ropinirole …
0.25mg 0.25mg
16. M/s Hilton 047377 Ronirole 0.5mg Do Do Brand name is
Pharma Tablets corrected as Ronirol
(Pvt.) Ltd., Each tablet and composition as
Karachi. contains:- Ropinirole
Ropinirole … 0.5mg Hydrochloride eq.
to Ropinirole …
0.5mg
17. M/s Hilton 047378 Ronirole 1mg Do Do Brand name is
Pharma Tablelts corrected as Ronirol
Ropinirole … 1mg Hydrochloride eq.
to Ropinirole …
1mg
to Ropinirole …
2mg
to Ropinirole …
3mg
to Ropinirole …
4mg
21. M/s Hilton 047485 Citanew Oral Drops 29-01-2008 Registration of the Reference
Pharma Each tablet drug is renewed composition is
(Pvt.) Ltd., contains:- w.e.f. 29-01-2018 to corrected as Each
28-01-2023. ml contains and
Karachi. Escitalopram …
composition as
10mg
Escitalopram (as
Oxalate)
22. M/s Hilton 047484 Citanew 15mg Do Do Composition is
Pharma Tablets corrected as
(Pvt.) Ltd., Each tablet Escitalopram (as
Karachi. contains:- Oxalate)
Escitalopram …
15mg
23. M/s Hilton 047486 Destina Syrup Do Do Composition is
Pharma Each ml contains:- corrected as
(Pvt.) Ltd., Desloratidine … Desloratadine …
Karachi. 0.5mg 0.5mg
24. M/s Hilton 048505 Smokik Tablets 14-02-2008 Registration of the Composition is
Pharma Each tablets drug is renewed corrected as
(Pvt.) Ltd., contains:- w.e.f. 14-02-2018 to Bupropion (as
13-02-2023. hydrochloride)
Karachi. Buspropion …
100mg
25. M/s Hilton 073727 Artem 20mg 23-01-2013 Registration of the Composition is
Pharma Injection drug is renewed corrected as
(Pvt.) Ltd., Each ml contains:- w.e.f. 23-01-2018 to Artemether
22-01-2023.
Karachi. Atrmether … 20mg
26. M/s Hilton 073733 Hilyte Sachet Do Do Brand name is
Pharma Each sachet corrected as Hilyte-
(Pvt.) Ltd., contains:- R Sachet
Karachi. Rice Powder … 6g
Sodium citrate0.58
Sodium chloride …
0.35g
Potassium chloride
… 0.3g
27. M/s Hilton 073734 Sitaglu Tablets Do Do Brand name is
Pharma 25/500 corrected as Sitaglu
(Pvt.) Ltd., Each tablet Met and
Karachi. contains:- composition as
Sitagliptin Metformin HCl
Phosphate … 25mg
Metformin …
500mg
28. M/s Hilton 073735 Hilten 300mg Do Do Reference
Pharma Tablets composition is
(Pvt.) Ltd., Each tablet corrected as Each
Karachi. contains:- film coated tablet
Tenofovir disoproxil contains and
… 300mg composition as
Tenofovir
disoproxil fumarate
eq. to Tenofovir
disoproxil …
300mg
29. M/s Hilton 030050 Myteca 5mg Tablets 19-03-2003 Registration of the Brand name is
Pharma Each tablets drug is renewed corrected as Myteka
(Pvt.) Ltd., contains:- w.e.f. 19-03-2018 to
Karachi. Montelukast Acid 18-03-2023.
… 5mg
30. M/s Hilton 030051 Myteca 10mg Do Do Brand name is
Pharma Tablets corrected as Myteka
(Pvt.) Ltd., Each tablets
Karachi. contains:-
Montelukast Acid
… 10mg
31. M/s Hilton 006846 Tiamutin Do Do Brand name s
Pharma 145%powder (vet) corrected as
(Pvt.) Ltd., Tiamulin hydrogen Tiamutin 45%
Karachi. fumarate … 45gm Powder (vet)
32. M/s Hilton 00886- Supraxime Capsule 26-03-2008 Registration of the Registration No. is
Pharma Ex 400mg drug is renewed corrected as
(Pvt.) Ltd., Each capsule w.e.f. 26-03-2018 to 000886-EX and
25-03-2023.
Karachi. contains:- strength as
Cefixime … 200mg Cefixime … 400mg
33. M/s Hilton 00884- Supraxime 100mg Do Do Registration No. is
Pharma Ex Suspension corrected as
(Pvt.) Ltd., Each 5ml contains:- 000884-EX
Karachi. Cefixime … 100mg
34. M/s Hilton 00882- Meloxicam 15mg Do Do Registration No. is
Pharma Ex Tablet corrected as
(Pvt.) Ltd., Each tablet 000882-EX and
Karachi. contains:- brand name as
Meloxicam … 15mg Moxicam.
35. M/s Hilton 00883- Meloxicam 7.5 Do Do Registration No. is
Pharma Ex Tablets corrected as
(Pvt.) Ltd., Each tablet 000883-EX and
Karachi. contains:- brand name as
Meloxicam … Moxicam.
7.5mg
Decision: Registration Board noted the information.
Case No. 52 M/s. The Searle Company Limited, Karachi.

M/s The Searle Company Limited, Karachi formerly M/s. Searle Pakistan Limited, Karachi to
has applied for regularization of renewal of registration of their products under SRO 1005(I)/2017. Case was
placed in 277th meeting and Board regularized their renewal and accordingly validity has been granted as per
initial registration date. Meanwhile firm has submitted change of brand name letter issued on 20-05-2008. Firm
requested to consider their change of brand name date towards renewal and to grant validity accordingly.
Furthermore firm also submitted renewal of year 2018 on the basis of change of brand name. Detail is as under;
Sr. Reg.
Brand Name Date of Reg. Decision of the Board New Validity
No. No.
1. 047389 Rhulef Tablet 05-01-2008 Registration Board acceded to 19-05-2018
Each tablet contains: Change of brand request of the firms and
Leflunomide …100mg name dated decided to grant/regularize
20-05-2008 the renewal till 04-01-2018.
2. 047390 Rhulef 10mg Tablet Do Do Do
Leflunomide …. 10mg
3. 047391 Rhulef 20mg Tablet Do Do Do
Leflunomide …. 20mg
Decision: Registration Board considered the renewal application from change of brand name date
and granted new validity till 19-05-2018.
Case No. 53 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 the consideration of Registration Board.
i) With Prescribed Fee
a) M/s Bloom Pharmaceuticals (Pvt) Ltd., Hattar.
Sr. Reg. Initial date of

Product Name Application Receiving date
No. No. Registration
1. 033734 Sivarol Suspension 01-09-2004 Due date (31-08-2014)
Each 5ml contains:- Received within 60 days after expiry of
Cefixime … 100mg Reg. with fee of Rs.20,000/- deposited on
21-10-2014.
Decision: Registration Board acceded to request of the firm and decide to grant renewal till 31-08-
2019
Case No. 54 M/s. Otsuka Pakistan Limited, Karachi.

M/s. Otsuka Pakistan Limited, Karachi has applied for renewal of registration of their
products. Detail of which is as under;
Sr. Reg. Initial date of
Product Name Application Receiving date
No. No. Registration
1. 045744 Abilify Tablet 26-07-2007 Due date (25-07-2017)
Each tablet contains:- Application is received after approx. 8 month
Aripiprazole … 10mg of expiry of registration on 22-03-2018.
Renewal of year 2012 has also not submitted.
2. 045745 Abilify Tablet Do Do
Aripiprazole … 15mg
In Form 5-B, firm has stated that initial registration had been given in July 2007, but due to price
fixation matter they have not marketed their product. That is why they are applying for renewal for the
first time.
Submitted for consideration of Board please.
Item No. IV: Division of Biological Evaluation and Research
Item Details of application No. of

No. Cases
a. Agenda of Previous meeting deferred due to paucity of time 8
b. Imported Human Biologicals from Non-Reference Countries 5
c. Imported Veterinary Biologicals from Non-Reference 11
Countries
d. Local Human Biologicals 2
e. Miscellaneous/ Deferred cases 37
f. Additional Agenda 08
Total 71
Sr. Assistant Director Designated No. No. of Cases

No.
a. Mr. Khurram Khalid AD-I 20
b. Mr. M. Sarfraz Nawaz AD-II 29
c. Mr. M. Zubair Masood AD-III 22
Case No.01: Agenda of Previous meeting deferred due to paucity of time
a. Change of manufacturing site of Benlysta 120mg (Reg. No. 077546) &Benlysta 400mg
(Reg. No. 077547) applied by M/s GSK Pakistan Limited, Karachi.
M/s GSK Pakistan Limited, Karachi applied for the change in manufacturing site of their
already registered product Benlysta 120mg (Reg.077546) and Benlysta 400mg (Reg. No. 077547) as
per following details:
Sr. Reg. Brand Name & Previous Manufacturing Site New Manufacturing Site
No. No. Composition
1. 077546 BENLYSTA Product License Holder: Product License Holder:
Powder for concentrate M/s Glaxo Group Ltd., UK. M/s Glaxo Group Ltd., 980 Great
for solution for infusion Manufacturing Site: West Road, Brentford, Middlesex,
Each vial contains: M/s Hospira Inc., 1776 North TW8 9GS, United Kingdom.
Belimumab…120mg Centennial Drive, McPherson, Manufacturer:
2. 077547 BENLYSTA Kansas, 67460-1247, USA M/s GlaxoSmithKline
Powder for concentrate Secondary Packaging: manufacturing S.P.A.,
for solution for infusion M/s GlaxosmithKline StradaProvincialeAsolana No. 90,
Each vial contains: Manufacturing S.p.a., San Polo di Torrile, Parma, 43056,
Belimumab…...400mg StradaProvincialeAsolana no, Italy (Site also responsible for batch
90 San Polo di Torile Parma, release in the EU, primary and
43056, Italy secondary packaging)
The firm has submitted the following documents for both products:
1. Application on Form-5A
2. Fee challan of Rs. 50000/-
3. Copy of initial registration letter dated 27-08-2015
4. Valid Legalized CoPP No.03/17/111782 dated 15-08-2017 andCoPP No.03/17/111780 dated 15-
08-2017issued by European Medicines Agency (EMA) indicating new site.
5. Site master file.
Decision: Keeping in view valid legalized CoPP and approval of EMA (Reference Regulatory
Authority); Registration Board approved the change in manufacturing site from
M/s Hospira Inc., 1776 North Centennial Drive, McPherson, Kansas, 67460-1247,
USA & M/s GlaxosmithKline Manufacturing S.p.a., StradaProvincialeAsolana no.
90, San Polo di Torile Parma, 43056, Italy to M/s GlaxoSmithKline manufacturing
S.P.A., Strada Provinciale Asolana No. 90, San Polo di Torrile, Parma, 43056, Italy
(Site also responsible for batch release in the EU, primary and secondary
packaging) subject to compliance of current Import Policy for inspection of
manufacturing units for finished products.
b. Transfer of registration of veterinary vaccines applied by M/s Hipra Pakistan Limited,

Lahore in their name from M/s Marush Private Limited, Lahore.
M/s Hipra Pakistan Limited, Lahore applied for the transfer of registration of already approved
veterinary vaccines in their name from M/s Marush Private Limited, Lahore as per following details:
Sr. Reg. No. Brand Name & composition Initial Registration Date of Last
No. Date & Date of Renewal
Transfer Submission
1. 020805 HIPRAGUMBORO – CH/80 20-01-1998 03-03-2015
Oral freeze-dried tablet
&
Composition per dose (0.03ml): 16-04-2010
Live attenuated Infectious Bursal Disease
Virus, clone CH/80…………………103.5-
106.5TCID50*
*50% infectious dose in tissue culture

2. 048134 BRONIPRA-ND/IBD 03-03-2008 03-03-2015
Injectable Emulsion &
Composition per dose (0.5ml) 16-04-2010
Inactivated Newcastle disease virus, strain La
Sota………………….IHA 1/16-1/1024(*)
Live infectious Bronchitis virus, strain
H52…………………..……….…SN:2.4-
16(**)
Inactivated infectious bursal disease virus,
strain W2512…………….ELISA: 357-
13500(***)
(*)IHA: Antibody titre obtained by

hemagglutination inhibition.
(**)SN: Titre of antibodies against IBV in
seroneutralizing units.
(***) ELISA = Titre of antibodies against
IBDV in ELISA units
The firm has submitted the following documents:
1. Application on Form-5A
2. Fee Challan of Rs. 100000/-
3. Copy of Initial registration letter and last renewal submission
4. Termination letter in name of M/s Marush Private Limited, Lahore
5. Sole Agency Letter in name of M/s Hipra Pakistan Limited, Lahore
i. The renewal status has been verified from RRR section.
ii. The name of product at serial no. 2 of table is mentioned in CoPP as Bronipra-ND/IBDwhile
on initial registration letter the name is Bronipar-ND/IBD
iii. NOC from existing registration holder is not provided.
iv. Accelerated stability data is not provided (The firm has now provided the data).
Decision:
Registration Board advised DBER to issue a show cause notice to M/s Marush Private
Limited, Lahore to explain why not the registrations/ permission of Hipragumboro-CH/80and
Bronipar-ND-IBD are withdrawn as their sole agency agreement has been terminated by M/s
Laboratorios Hipra, S.A. (Hipra), Av. De La Selva, 135, in Amer (Girona), Spain. The Board
further advised to ask the firm that if they desire to be heard in person they may inform
accordingly.
c. Imported Human Biological from Reference countries.

1. Name and address of M/s GlaxoSmithKline Pakistan Limited 35-Dockyard Road, West Wharf,
Importer Karachi
Detail of DSL Copy of DSL No. 473 valid till 18-08-2017
Receipt of application for renewal dated 29-08-2017 is submitted.
Name and address of Product License Holder:
Manufacturer M/s GlaxoSmithKline GmbH & Co.KG Prinzregentenplatz 9 81675 Munich
Germany
Manufacturer:
M/s GlaxoSmithKline Beecham Pharma GmbH & Co. KG Zirkusstrabe 40
01069 Dresden Germany
Brand Name +Dosage Fluarix Tetra
Form + Strength Influenza split vaccine, quadrivalent Suspension for i.m. injection
Diary No. Date of R& I & Dy No. 17492/2018(R&I) Date: 11-05-2018.
fee Rs. 100,000/- dated 11-05-2018
Composition Each 0.5ml suspension contains:
Purified, inactivated influenza virus of the following strains:
A/Michigan/45/2015(H1N1) pdm09-like strain (A/Singapore/GP1908/2015,
IVR-180)….15µg hemagglutinin)
A/Hong Kong/4801/2014 (H3N2)- like strain (A/Hong
Kong/4801/2014,NYMC X-263B……….15µg hemagglutinin
B/Brisbane/60/2008-like strain (B/Brisbane/60/2008, wild type) [Victoria
lineage]………….……………..15µg hemagglutinin
B/Phuket/3073/2013- like strain B/Phuket/3073/2013, wild type
[yamagatalineage]……………………….15µg hemagglutininv
Pharmacological Group Influenza vaccine
Type of Form Form-5A
Finished Product USP
Specification
Shelf Life 12 months at 2-80C
Document Details CoPP No. 24/2018dated 06-03-2018 indicating availability of product in
country of origin.
Pack size & Demanded 1’s single dose (0.5ml) injection/
Price Not provided.
International Availability Germany, Austria, Belgium
Products already registered Not available
in Pakistan
Remarks of the evaluator Firm has applied for WHO recommended strains for 2017/2018 for Northern
Hemisphere (which includes Pakistan). Moreover, the firm has submitted that
WHO recommended strains for next season i.e. 2018-2019 are estimated to
be approved by German Authorities in August/September 2018 and
accordingly firm would communicate the same to DRAP, once approved.
Comparison of virus/strains applied by the firm and WHO recommended
strains for 2017-2018 and 2018-2019 are as under:
Strains applied WHO WHO

by the Firm recommended recommended
strain for 2017- strain for 2018-
2018 2019
A/Michigan/45/2015 an A/Michigan/45/2015 an
(H1N1) pdm09-like (H1N1)pdm09-like virus A/Michigan/45/2015
strain (H1N1)pdm09-like
(A/Singapore/GP19 virus
08/2015, IVR-180)
A/Hong an A/Hong an
Kong/4801/2014 Kong/4801/2014 A/Singapore/INFIM
(H3N2)- like strain (H3N2)-like virus H-16-0019/2016
(A/Hong (H3N2)-like virus;
Kong/4801/2014,N
YMC X-263B
B/Brisbane/60/2008- a B/Brisbane/60/2008- a B/Colorado/06/2017-
like strain like virus like virus
(B/Brisbane/60/2008 (B/Victoria/2/87
, wild type) lineage);
[Victoria lineage]
B/Phuket/3073/2013- a B/Phuket/3073/2013- a B/Phuket/3073/2013-
like strain like virus like virus
B/Phuket/3073/2013, (B/Yamagata/16/88
wild type lineage).
[yamagatalineage]
Decision: Keeping in view valid legalized CoPP and approval of Germany (Reference Regulatory
Authority); Registration Board approved the product subject toprice fixation by the Federal Government
and compliance of current Import Policy for Finished Drugs.
d. Registration of Dengue Vaccine applied by M/s Sanofi Aventis Pakistan Limited, Karachi.
Registration Board in its 277th meeting reviewed WHO’s interim position regarding use of
Dengue vaccine and deliberated that in high prevalence settings, the dengue vaccine can have
significant population level benefits. However, until a full review is conducted by WHO that is likely
to be available not earlier than April 2018, vaccination only in individuals with a documented past
dengue infection, either by a diagnostic test or by a documented medical history of past dengue illness
is recommended. Registration Board further decided as follows:
“Registration Board, DRAP will review case further as soon decision of WHO Strategic
Advisory Group of Experts (SAGE) on immunization becomes available in April 2018 and/ or
new findings become available in the meantime based upon either post marketing safety
surveillance data obtained domestically/ internationally or new findings from clinical trials.”
Now the WHO has published “Revised SAGE recommendation on use of dengue vaccine” dated 19-
04-2018. The summary is as follows:
“For countries considering vaccination as part of their dengue controlprogram, a “pre-
vaccination screening strategy” would be the preferredoption, in which only dengue-seropositive
persons are vaccinated.Conventional serological testing for dengue virus IgG (e.g. dengue
IgGELISA) could be used to identify persons who have had previous dengueinfections. Sensitivity
and specificity of dengue IgG ELISA should beassessed in a local context, and will depend on the
prevalence of otherflaviviruses, and past use of flavivirus vaccines (such as Japaneseencephalitis
and yellow fever vaccines). Currently available rapid diagnostic tests - despite their lower
sensitivityand specificity to detect past dengue infection compared withconventional dengue IgG
ELISA - could be considered in hightransmission settings until better tests are available. In
settings with highdengue transmission (high numbers of seropositives), a test with lowerspecificity
might be acceptable.”
Decision: Registration Board advised DBER to write a letter for further deliberation in next
Registration Board meeting to concerned divisions including EPI etc.
e. Update in Prescribing Information for Actemra 162mg/0.9ml PFS applied by M/s Roche
Pakistan Limited, Karachi.
M/s Roche Pakistan Limited, Karachi has applied for the approval of new indication for their
under registration product Actemra 162mg/ 0.9ml. The said product was approved in 271st meeting of
Registration Board as per following details:
Name of Manufacturer Brand Name & Indications as mentioned in previous CoPP New applied
Composition Indication in
addition to
previous
indications
Product License Actemra Actemra in combination with methotrexate Actemra is
Holder: 162mg/0.9ml (MTX) is indicated for the treatment of indicated for the
M/s Roche Registration (Solution for moderate to severe active rheumatoid arthritis treatment of
Limited, 6 Falcon Way, Injection) in adult patients who have either responded Giant Cell
Shire Park, Welwyn inadequately to, or who were intolerant to, Arteritis (GCA)
Garden City AL7 1TW, Each pre-filled previous therapy with one or more disease in adult patients.
United Kingdom. syringe (0.9ml) modifying anti-rheumatic drugs (DMARDs)
Manufacturer: contains: or tumor necrosis factor (TNF) antagonists, In
M/s Vetter Pharma- Tocilizumab….16 thses patients, RoActemra can be given as
Fertigung GmbH & Co 2mg monotherapy in case of intolerance to MTX
KG, Schutzenstrasse 87 or where continued treatment with MTX is
and 99-101, 88212 inappropriate.
Ravensburg, Germany. Actemra has been shown to reduce the rate of
progression of joint damage as measured by
X-ray and to improve physical function when
given in combination with methotrexate.
The firm has submitted the following documents:
i. Application along with fee challan of Rs. 5000/-
ii. Difference between existing and proposed information in tabulated form
iii. Proposed SmPC
iv. Valid legalized CoPP No. 02/18/118140 dated 08-03-2018 issued by EMA indicating new
indication.
Decision: Keeping in view valid legalized CoPP and approval of EMA (Reference Regulatory
Authority); Registration Board approved the new indication for Actemra
162mg/0.9ml PFS (Reg. No. 090643).
f. Imported Human Biological from Non- reference country applied by M/s Gene-Tech
laboratories, Karachi deferred in 271st meeting of Registration Board.
Following product of M/s Gene-Tech Laboratories, Karachi was deferred in 271st meeting of
Name and address of Importer M/s Gene-Tech laboratories head office. 246/B, PECHS,Block-6,
Karachi 75400
Detail of Drug Sale License Drug Sale License No.0197 valid till 15-08-2018
Name and address of Manufacturer CinnaGen Co. West sixth st., 3rd sq., simindast industrial area, karaj,
alborz, I.R.IRAN.
Brand Name +Dosage Form + Cinnopar 2.4ml Multidose Pen 250mcg/ml
Strength (Solution for injection)
Diary No. Date of R& I & fee Dy. No 2219 (R&I) dated 05.04.2017
Rs.100,000 dated 24.03.2017
Composition Each Prefilled pen (ml) contains:
Teriparatide........................ 250mcg/ml (2.4ml)
Pharmacological Group Parathyroid hormone, modulator hormones
Shelf Life 2 years
Document Details Legalized CoPP No. REF: 665/177158 Dated:14.2.2017indicating
availability of product in country of origin.
Pack size & Demanded Price 1pen / MPR is not provided
International Availability ForteoofLilly USFDA
Products already registered in Pakistan Forsteo of Eli Lilly Pakistan
WHO Biosimilarity Data Submitted by the firm
Guidelines
Quality Comparison Elucidation of Chemical Structure
Physicochemical i. Amino Acid Sequencing by mass spectrometer.
Characterization ii. Peptide mapping and protein contents by RP-HPLC
iii. N-Terminal amino acid sequencing.
iv. CD Spectroscopy.
v. Fourier transform infrared spectroscopy.
vi. Molecular mass by MS analysis and SDS-PAGE.
Biological Activity i. Rat UMR-106 cell line is used for assessing the biological activity of Teriparatide.
ii. Human osteosarcoma cell line Saos-2 based bioassay.
Immunochemical Not provided.

properties The firm submit the EMA assessment report of another EMA approved teriparatide
Injection indicating that
rd
577
no analysis of immunogenicity parameters has been performed, because the
Applicant is of the opinion that a clinically relevant immunogenic potential of RGB-
10 appears to be highly unlikely, as the immunogenic potential of Forsteo has proved
to be negligible in the clinical studies for registration purposes as well as over the
past ten years on the market.
Impurities a. RP-HPLC to determine protein purity.
b. Determination of Dimer and related Substances of higher molecular masses by
SE-HPLC
Stability Studies Stability studies is provided.
Non-clinical Toxicology
Comparison i. Repeated-dose toxicity study in wistar-rat by subcutaneous route.
In-vivo Studies ii. To assess comparative study of the acute toxicity of CinnoPar® and
Forteo® when administered by single subcutaneous injection in wistar-rats.
iii. The local tolerance study of CinnoPar® was performed as part of the repeated-
dose studies.
Clinical Comparison A phase III, randomized, two-armed, double-blind, parallel, active-controlled clinical
trial to compare
efficacy and safety of biosimilar recombinant human parathyroid hormone [1-34]
(CinnoPar®) with the
reference product (Forteo®) in postmenopausal osteoporotic women (n=94,
Forteo=45 &Cinnopar=49)
Decision of 271st “Registration Board deferred the product for submission of complete real-time
meeting of stability data of 24 months for three batches”
Registration Board:
Remarks of Evaluator Now the firm has provided complete real-time stability data of 24 months for three
batches.
Decision: Keeping in view the biosimilarity data and submitted CoPP indicating the product is
available in country of origin; Registration Board approved the product subject to price fixation by
Federal Government and compliance of current Import Policy for finished drugs.
Case No.02: Imported Human Biologicals from Non-reference countries.
1. Name and address of M/s 3A Diagnostics

Importer 12-F-1, Mehmood Chowk, Main Johar Town, Lahore
Name and address of OlymvaxBiopharmacueticals Inc.
Manufacturer No.99, Tianxin road, High-tech Zone, Chengdu, China
Brand Name +Dosage Form + Olvaxtar-MEN
Strength
Diary No. Date of R& I & fee 15522/2017(R&I) dated 19-09-2017.
PKR. 100,000/- dated 10-08-2017.
Composition Each dose of 0.5 ml vial contains:
Meningococcal Polysaccharide vaccine group A strain……50µg.

Meningococcal Polysaccharide vaccine group C strain……50µg.
Meningococcal Polysaccharide vaccine group Y strain……50µg.
Meningococcal Polysaccharide vaccine group W135 strain……50µg.
Lactose (Inactive)….5-10mg.
Diluent…. PBS 0.5ml vial

Pharmacological Group Human Vaccine
Finished Product Specification CP (Chinese Pharmacopeia)
Shelf Life 24 Months (2-80C)
Document Details 1. Legalized CoPP issued by Sichuan Provincial Food & Drug
Administration, China dated 21-03-2017.
2. Legalized Drug Manufacturing License issued by China Food and
Drug Administration dated 01-01-2016.
3. Original legalized Exclusive Marketing Authorization Letter dated
03-01-2017.
4. Legalized Approval for Drug Re-Registration issued by Sichuan
Food and Drug Administration on 09-06-2015.
5. Legalized GMP Certificate issued No.CN20120128 dated 23-11-
2012.
6. Legalized Free Sale Certificate issued by Sichuan Provincial Food
& Drug Administration dated 23-05-2017.
Pack size & Demanded Price 1's vial + 1's vial (diluent)/ USD 20 per dose
Details of DSL Copy of DSL No. 25-A/AiT/11/2014 Valid upto 11-08-2018
International Availability China
Products already registered in MENPOVAX-4
Pakistan MENCEVAX ACWY VACCINE
Remarks of the evaluator The firm has demanded CP (Chinese Pharmacopeia) specifications and
the submitted documents follow the same. However the product is
available in BP.
Decision: Registration Board deferred the case for clarification by the firm regarding
demanded Chinese Pharmacopoeia specifications while the product is available in British
Pharmacopoeia.
2. Name and address of M/s 3A Diagnostics

Importer 12-F-1, Mehmood Chowk, Main Johar Town, Lahore
Name and address of OlymvaxBiopharmacueticals Inc.
Manufacturer No.99, Tianxin road, High-tech Zone, Chengdu, China
Brand Name +Dosage Form + Olvaxtar-TT
Strength
PKR. 100,000/- dated 11-10-2017.
Composition Each 1.0 ml of Rabies Vaccine (Vero Cell) for Human Use, freeze-
Dried contains:
Active Name of Ingredients Unit Dose

Ingredients
and Inactive
Ingredients
Active Tetanus Toxoid 4.5Lf
Ingredients
Inactive Sodium Chloride 4.25mg
Ingredients Aluminum hydroxide 1.0mg
adjuvant
Disodium Hydrogen 0.19-0.24mg
Phosphate
Monopotassium phosphate 0.031-
0.039mg/vial
Pharmacological Group Vaccine, Biological Product
Finished Product Specification CP (Chinese Pharmacopeia)
Shelf Life 24 Months 2-80C
Document Details 1. Valid Legalized CoPP issued by Food and Drug Administration of
Sichuan Province, China legalized on 22-08-2017.
2. Legalized GMP Certificate issued No.CN20160067 dated 30-12-
2016.
3. Original Legalized Marketing Authorization dated 08-08-2017.
4. Legalized Free Sale Certificate issued by Sichuan Provincial Food
& Drug Administration legalized on 22-08-2017.
5. Legalized Drug Registration License issued by China Food and
Drug Administration legalized on 22-08-2017.
6. Legalized Drug Manufacturing License issued by China Food and
Drug Administration legalized on 22-08-2017.
Pack size & Demanded Price 1's vial/ USD 1.5 per dose
Products already registered in ABSORBED TETANUS VACCINE manufactured by EVANS
Pakistan MEDICAL LTD UK
Remarks of the evaluator 1. The firm has submitted review of domestic and international
clinical trials and not conducted clinical trials of their product.
2. The firm has demanded CP (Chinese Pharmacopeia) specifications
and the submitted documents follow the same. However the product
is available in BP.
Decision: Registration Board deferred the case for submission of following by the firm:
a. Clinical trial data of Olvaxtar-TT
b. Clarification by the firm regarding demanded Chinese Pharmacopoeia specifications while the
product is available in British Pharmacopoeia.
3. Name of Importer Helix Pharma (Pvt.) Ltd.,
Hakimsons House, A/56, S.I.T.E
Manghopir Road, Karachi-75700
Name of Manufacturer M/s Intas Pharmaceutics Limited Plot No. 423/P/A, Sarkhej-Bavla
Highway, Village: Moraiya, Taluka: Sanand, Ahmedabad-382 213,
Gujarat, India
Brand Name +Dosage Form + Ecept
Strength Etanercept Solution for Injection 25mg/0.5ml
PFS 25mg/0.5ml
Composition Ecept (Etanercept)
Each 0.5 ml PFS contains: Etanercept ..25mg
Finished product specifications In-house
Pharmacological Group Human tumour necrosis factor
Shelf life 30Months at 2-80C
Approval status in Reference Enbrel by M/s Pfizer
countries
International availability India
Products already registered in Enbrel by M/s Pfizer
Pakistan
Type of Form Form 5-A,
Dy No & Date of application, Dy. No. 3928(R&I) Date: 09-03-2017
Fee submitted Rs. 100,000/- Date: 02-03-2017
Demanded Price / Pack size Rs. 12,300 /- for 1’s PFS
General documentation CoPP, Certificate No. MFG/WHO-COPP/INTAS/2016/141518
DSL No.0063 valid till 24-01-2018 renewal receipt dated 15-01-2018
akimsons House, A/56, S.I.T.E
Manghopir Road, Karachi-75700
Highway, Village: Moraiya, Taluka: Sanand, Ahmedabad-382 213,
Gujarat, India
Brand Name +Dosage Form + Ecept
Strength Etanercept Solution for Injection 50mg/1ml
PFS 50mg/1ml
Composition Ecept (Etanercept)
Each 1.0 ml PFS contains Etanercept ..50mg
Finished product specifications In-house
Pharmacological Group Human tumour necrosis factor
Shelf life 30Months at 2-80C
Approval status in Reference Enbrel by M/s Pfizer
countries
International availability India
Products already registered in Enbrel by M/s Pfizer
Pakistan
Dy No & Date of application, Dy. No. 3927(R&I) Date: 09-03-2017
Fee submitted Rs. 100,000/- Date: 02-03-2017
Demanded Price / Pack size Rs. 100,000/- for 4’s PFS
DSL No.0063 valid till 24-01-2018 renewal receipt dated 15-01-2018
The firm has submitted the bio-similarity data asper following detail:
Guidelines
Quality Comparison Elucidation of Chemical Structure
Physicochemical i. Peptide Map by reverse phase chromatography.
Characterization ii. Intact mass by mass spectrometry.
iii. Molecular weight correctness by SDS-PAGE.
iv. Glycan analysis by fluorescence detector (HPLC-FLD)
v. Secondary structure of protein analyses by CD (Circular Dichroism).
vi. UV Spectroscopy for absorbance maxima of product.
vii. Tertiary structure measure by Intrinsic Fluorescence.
viii. Molecular weight related impurities by SE-HPLC.
ix. Hydrophobic Interaction Chromatography used to identify hydrophobic
groups on protein molecule.
x. Iso-electric Focusing.
Biological Activity In-vitro Biological activity neutralization of cytotoxic effect of etanercept
produces cytotoxic effect on L929 (Mouse connective tissue) cell line.
Immunochemical ELIZA test performed

properties
Impurities a. Process-Related Impurities and contaminants
b. Product Related Impurities
Stability Studies Stability studies of clinical trial batch is provided.

Non-clinical Pre-clinical Studies
Comparison In-vitro Studies
i. In-vitro Studies Invitro efficacy testing on L929 (Mouse connective tissue) cell line.
ii. In-vivo Studies In-vivo Studies
a. Biological/ i) Comparative Pharmacokinetics profile of Intas Etanercept and Enbrel ® in
Pharmacodynamic male swiss albino mice.
activity ii) Toxicology
Single dose toxicity Studies
b. Non- clinical a. Single Dose intravenous toxicity study in Wistar rat.
toxicity as b. Single dose subcutaneous toxicity study in Wistar rat.
determined in one c. Single Dose intravenous toxicity study in Swiss Albino Mice.
repeat dose toxicity d. Single Dose subcutaneous toxicity study in Swiss Albino Mice.
study Repeated dose toxicity studies
a. Repeated-Dose subcutaneous toxicity study in Wistar rats.
b. Repeated-Dose subcutaneous toxicity study in New Zealand White
rabbits.
Local Tolerance
a. Skin sensitization study in Guinea Pigs.
b. Skin sensitization test in Rabbits.
Clinical Comparison i. To compare the pharmacokinetic of Etanercept manufactured by Intas
Pharmaceutical Limited, Ahmedabad versus Enbrel® (10 patients in test arm
and 10 patients in reference arm)
ii. A prospective, comparative, open label, randomized, multicentric phase III
study to compare the safety and efficacy of Etanercept manufactured by
Intas Pharmaceutical Ltd. Against Enbrel in patients with active
Rheumatoid Arthritis (n=106,5 patients discontinuous, 102 patients
complete the study, Test arm n= 77 & Reference arm n=25)
iii. Published data of drug molecule is provided.
Decision: Keeping in view the biosimilarity data and submitted CoPPs indicating the products
are available in country of origin; Registration Board approved the products subject to price fixation
by Federal Government and compliance of current Import Policy for finished drugs.
5. Name and address of M/s Gene-Tech laboratories head office. 246/B, PECHS, Block-6, Karachi
Importer 75400
Detail of Drug Sale License Drug Sale License No.0197 valid till 15-08-2018
Name and address of Nanhailongtime Pharmaceutical Co., Ltd.
Manufacturer NanhaiShishan Information Technology Park, Foshan city, Guangdong
Province, P.R. China
Brand Name +Dosage Form Healofast, Lyophilized powder vial, 70,000IU Recombinant Human Basic
+ Strength Fibroblast Growth Factor
Diary No. Date of R& I & Dy. No 6948 (R&I) dated 22.06.2017
fee Rs.100,000 dated 22.06.2017
Composition Each lyophilized vial contains:
Recombinant Human Basic Fibroblast Growth Factor …70,000IU
Pharmacological Group Peptide Hormone
Finished Product
In House
Specification
Shelf Life 2 years (20C -80C)
Document Details Legalized CoPP No. 17-0006 Dated:05-01-2017
Pack size & Demanded Price 1’s, Rs. 2640/-
Products already registered in Not available
Pakistan
Evaluator remarks:
i. No similarity studies conducted on HEALOFAST to compare with other products.
ii. Approval of the molecule/formulation (in same dosage form and strength) in any reference
regulatory authority is not provided.
Decision: Registration Board deferred the case for submission of following by the firm:
a. Biosimilarity data of Healofast
b. Evidence of approval of formulation (in same dosage form and strength) in any reference regulatory
authority.
Case No.03: Imported veterinary Biologicals from Non-Reference Countries
Sr. Name and address of M/s Orion Group P-97, usman block, muslim town no. 1 near lasani pully,
No. Importer Sargodha RoadFaisalabad
1. Detail of DSL Copy of DSL No. 2657-FTC/DL valid upto 11-11-2018.
Name and address of M/s BIOTESTLAB Ltd.
Manufacturer Address: st. vladimirska, 57A, Vasilkov, Kiev region, 08600, Ukraine
Brand Name +Dosage Polimun ND IB EDS Inactivated Vaccine
Form + Strength Emulsion
Diary No. Date of R& I & 15932/2017(R&I) dated 22-09-2017.
fee PKR. 100,000/- dated 20-09-2017.
Composition In one dose prior to inactivation, at least:
Egg Drop Syndrome virus, strain <<EDS-76>> ≥3log 2HAU
Newcastle disease virus, strain <<La Sota>>, clone DK-124≥8,0lg EID50
Infectious Bronchitis virus, strain Chapayevsky, Massachusetts
Serotype ≥ 6,7 lg EID50
Pharmacological Group Poultry Vaccine

Finished Product European Pharmacopeia
Specification
Shelf Life 18Months at (2-80C)
Document Details Valid legalized GMP Certificate No GMP 10/17//valid till: 02-11-2020
Legalized FSC Certificate No. UA 73100S 1012/9 valid till 14-06-2018
Pack size & Demanded 1000 Doses
Price Decontrolled
International Availability Ukraine
Products already IZOVAC ND- EDS-IB VACCINE
registered in Pakistan
Remarks of the evaluator Free sale certificate was valid upto 14-06-2018 and is not valid now.
Mr. Sarfraz
Decision: Registration Board deferred the case for clarification/ submission of following by the
firm:
a. Subtype of Infectious Bronchitis virus, Massachusetts serotype.
b. Valid legalized Free Sale Certificate.
2. Name and address of M/s Orion Group P-97, usman block, muslim town no. 1 near lasani pully,
Importer Sargodha RoadFaisalabad
Detail of DSL Copy of DSL No. 2657-FTC/DL valid upto 11-11-2018.
Brand Name +Dosage Polimun IBD Live Vaccine
Form + Strength Lyophilisate

fee PKR. 100,000/- dated 20-09-2017.
Composition Active substance:
Virus of infectious bursal disease of birds obtained on SPF-chiken embryos,
strain MB/5≥102EID50 per dose.
Specification
Shelf Life 18 months ( 2-80C)
rd
583
Pack size & Demanded 1000Doses
Price Decontrolled
Products already IZOVAC GUMBORO 3 VACCINE
Mr. Sarfraz
firm:
a. Immunological relevance of MB/5 strain in Pakistan.
3. Name and address of M/s Orion Group
Importer P-97 Usman Block, Muslim Town No.1, Near Lasani Pully, Sargodha
Road, Faisalabad 38090 – Pakistan.
Brand Name +Dosage Polimun ND INAC Inactivated Vaccine
Form + Strength Emulsion

fee PKR. 100,000/- dated 20-09-2017.
Composition Vaccine strains of the virus contain in a single dose, prior to inactivation, at
least:
Strain “La-Sota” DK-124 - ≥ 109EID50.

Specification
Price Decontrolled
Products already Izovac ND
Mr. Sarfraz
firm:
a. Immunological relevance of DK-124 strain in Pakistan.
Brand Name +Dosage Polimun IBD+
fee PKR. 100,000/- dated 20-09-2017.
Virus of infections bursal disease of birds obtained on SPF-chiken embryos,
strain MB/3≥102EID50 per dose
Specification
Price Decontrolled
Products already IZOVAC GUMBORO
Mr. Sarfraz
firm:
Brand Name +Dosage Polimun ND clon 124
fee PKR. 100,000/- dated 20-09-2017.
Strain La-Sota DK-124≥106.0EID50 per dose.
Specification
Price Decontrolled
Products already IZOVAC clone
Mr. Sarfraz
firm:
6. Name and address of Importer M/s Orion Group
P-97 Usman Block, Muslim Town No.1, Near Lasani Pully, Sargodha
Brand Name +Dosage Form + Polimun IBD Light Live Vaccine
Strength Lyophilisate
PKR. 100,000/- dated 20-09-2017.
Virus of infectious bursal disease of birds obtained on SPF-chiken
embryos, strain MB/20≥102EID50 per dose
Finished Product Specification European Pharmacopeia
Legalized FSC Certificate No. UA 73100S 1012/5 valid till 14-06-
2018
Pack size & Demanded Price 1000Doses/ Decontrolled
Products already registered in Izovac Gumboro
Pakistan
Remarks of the evaluator Mr. Free sale certificate was valid upto 14-06-2018 and is not valid now.
Sarfraz
Decision:Registration Board deferred the case for clarification/ submission of following by the firm:
Brand Name +Dosage Polimun ND CLONE 124+IB H-120 Live Vaccine
fee PKR. 100,000/- dated 20-09-2017.
Composition One dose of the vaccine contains:
Active substance:
Newcastle Disease virus, strain “La-Sota” DK-124 - ≥ 106.0EID50
Infectious Bronchitis virus, strain H120 ≥ 103.5EID50
Specification
Price Decontrolled
Products already GALLIMUNE 203 ND+IB INJECTABLE
Mr. Sarfraz
Decision: Registration Board deferred the case for clarification/ submission of following by the firm:
Brand Name +Dosage Polimun IB multi Live Vaccine
fee PKR. 100,000/- dated 20-09-2017.
Active Substance: strainBK-07 - ≥ 3.5lg EID50
Strain H120 ≥ 3.5 lg EID50
Specification
Price Decontrolled
Products already IB VACCINE of
registered in Pakistan SELMORE AGENCIES (PVT) LTD. LAHORE
Mr. Sarfraz
a. Immunological relevance of BK-07 strain in Pakistan.
9. Name and address of M/s Orion Group
Importer P-97 Usman Block, Muslim Town No.1, Near Lasani Pully, Sargodha
Brand Name +Dosage Polimun AE+POX
Form + Strength Lyophilisate and solvent
fee PKR. 100,000/- dated 20-09-2017.
Virus of Avian Encephalomyelitis, strain Calnek 1143-≥102.5EID50 per
dose.
Virus of Fowl Pox, strain cutter ≥102.8EID50 per dose.
Specification
Price Decontrolled
Products already POXIMUNE AE INJECTABLE.
Mr. Sarfraz
a. Immunological relevance of Cutter strain in Pakistan.
Brand Name +Dosage Polimun MAREK HVT Live Vaccine
fee PKR. 100,000/- dated 20-09-2017.
Turkey Herpesvirus serotype 3, strain FC-126 ≥ 1000 FFU in one dose.
Specification
Price Decontrolled
Products already BIOMAREK HVT
Mr. Sarfraz
a. Immunological relevance of FC-126 strain in Pakistan.
b. Valid legalized Free Sale Certificate
Brand Name +Dosage Polimun IB H-120 Live Vaccine
fee PKR. 100,000/- dated 20-09-2017.
Active substance: Infectious bronchitis virus of chickens received from
chicken SPF-embryos strain H-120 ≥ 3.5 lg EID50.
Specification
Price Decontrolled
rd
588
Products already OTTO BRONCHITIS VAC.
Mr. Sarfraz
Decision: Keeping in view the legalized GMP & FSC, Registration Board approved the product
subject to compliance of current Import policy for finished drugs. Before issuance of registration
letter, the firm will provide valid legalized FSC and Registration Board authorized its Chairman for
issuance of registration letter.
Case No.04: Local Human Biologicals
Name of Manufacturer/ Bulk Manufacturer:

Applicant M/s Gennova Biopharmaceuticals Limited, India
Local Repacking:
M/s Sami Pharmaceuticals (Pvt.) Limited, Karachi
Brand Name +Dosage Form + Ropo 2000IU Injection
Strength
Erythropoetin………2000IU
Finished product specifications BP Specs
Approval status in Reference Approved
countries
Products already registered in Epo of CCL, Epiao of AJ Mirza.
Pakistan
Type of Form Form-5
Dy No & Date of application, 23525(R&I)
Fee submitted 08-12-2017
Rs. 20000/- dated 08-12-2017
Demanded Price/ Pack size 1’s Vial/ As per DPC
General documentation GMP Inspection Report dated 03-10-2017

Name of Manufacturer/ Bulk Manufacturer:
Applicant M/s Gennova Biopharmaceuticals Limited, India
Local Repacking:
M/s Sami Pharmaceuticals (Pvt.) Limited, Karachi
Brand Name +Dosage Form + Ropo 4000IU Injection
Strength
Erythropoetin………4000IU
Finished product specifications BP Specs
Approval status in Reference Approved
countries
Products already registered in Epokine of RG Pharma, Epiao 4000IU of AJ Mirza.
Pakistan
Type of Form Form-5
Dy No & Date of application, 23526(R&I)
Fee submitted 08-12-2017
Rs. 20000/-
08-12-2017
Demanded Price/ Pack size 1’s Vial/ As per DPC
General documentation GMP Inspection Report dated 03-10-2017
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:
Documents required as per 278th RB decision i.for Documents submitted by firm
Biological Drugs (Concentrated Form/Ready to fill Form)
The firms shall provide legalized GMP certificate of Valid legalized GMP certificate No. NEW-WHO-
biological drug substance manufacturer abroad (who will GMP/CERT/PD/54994/2017/11/18706dated 24-
provide concentrate / ready to fill bulk of biological drug to 03-2017 of M/s Gennova Biopharmaceuticals
Pakistani manufacturers for further processing) as an Limited, India
evidence that the manufacturer is an authorized manufacturer
of biological drug in the country of origin.
The firms shall provide legalized free sale certificate/CoPP Valid legalized CoPP No.
either from country of origin or by any reference regulatory COPP/CERT/PD/62964/2017/11/21232/107098
authority as adopted by Registration Board of finished dated 27-10-2017 valid upto 23-03-2019 for
product as evidence that the final product has been 2000IU
manufactured by same concentrate/ready to fill bulk after &
submission of data to the concerned regulatory authority. Valid legalized CoPP No.
COPP/CERT/PD/62964/2017/11/21232/107099
dated 27-10-2017 valid upto 23-03-2019 for
4000IU
The firm shall provide the complete Bio-similarity studies of Details are included below.
the finished product of same source (bulk concentrate or
ready to fill) manufactured either from country of origin or by
any reference regulatory authority as adopted by Registration
Board to demonstrate the bio-similarity.
The firm shall provide the lot release certificate of the finished Not Provided.
product manufactured by same bulk concentrate/ ready to fill
from country of export (If applicable).
The firm shall provide the 6 months accelerated and real time Real Time & Accelerated Stability data (2000IU
stability studies for drug substance. & 4000IU) of 3 batches for 24 months.
The local manufacturer shall manufacture three trial batches The firm has performed the following tests:
of the finished biological product to finalize the formulation i. Appearance
and then perform analytical studies(Physicochemical and ii. pH
biological) including protein content, appearance, pH, iii. Osmolality
Osmolarity, composition of key excipients including iv. Potency by ELISA
stabilizers (if formulation is same), visible/subvisible v. Immunoblot Test
particles, identity testing to parent molecule, purity testing, in vi. Abnormal/ Undue Toxicity (01 Batch)
vitro biological activity, sterility, Pyrogen content, safety, vii. Sterility Test
potency and toxicity with support of iso-electro focusing data, viii. Bacterial Endotoxin Test
gel electrophoresis, Western-Blot and other analytical
techniques). The firm shall submit the results for processing
of registration application.
The manufacturer shall perform all tests locally as detailed on The firm has submitted COAs of 03 batches for
Certificate of analysis. both strengths indicating following tests are
performed:
i. Appearance
ii. pH
iii. Weight/ml
iv. Osmolality
v. Extractable Volume
vi. Assay
vii. Sterility Test
viii. Bacterial Endotoxin Test
The firm shall also provide the list of finished products being Not Provided.
manufactured from same bulk concentrate or ready to fill
form in any country of the world (if available).
Regular monitoring through pharmacovigilance SOPs for Post Marketing Surveillance System are
reporting system shall be observed through proper submitted.
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 provide the agreement with the source (of bulk Provided.
concentrate/ready to fill) that if there shall be any critical
change in manufacturing process, biological systems used to
manufacture, etc. the firm shall inform DRAP immediately
along with relevant documents.
The firm shall inform DRAP if there shall be any adverse Provided.
event or ADR reporting from the country of manufacture of
concentrate/ready to fill bulk and finished product as required
vide Rules 30 of Drug (LR&A) Rule.
Bio-similaritystudies 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. Capillary Zone Electrophoresis
characterization ii. Polyacrylamide Gel Electrophoresis
iii. Peptide Mapping
iv. N-Terminal Sequencing
v. Protein Content
(Compared with reference standard instead of Innovator)
Biological Activity Potency assay in Normocythaemic mice (compared with reference standard instead
of Innovator)
Immunochemical Immunoblotting
properties
Impurities i. Dimers and related substances of High molecular mass
ii. Sialic acid content
iii. Host Cell Protein
iv. Host Cell DNA
Stability Studies Not Provided
Non-clinical Studies i) In vitro studies are not provided.
i. In-vitro Studies ii) In-vivo studies
ii. In-vivo Studies a. Acute subcutaneous toxicity studies of Erythropoetin in Swiss Albino mice
b. Acute subcutaneous toxicity study of Erythropoetin in Sprague Dawley Rat.
c. Primary Skin irritation study of Erythropoetin in Rabbit
d. Allergic contact sensitization potential of Erythropoetin in guinea-pigs by
Magnusson and Kligman method.
e. Subchronic subcutaneous toxicity study of Erythropoetin in Swiss Albino
Mouse
f. Subchronic subcutaneous toxicity study of Erythropoetin in New Zealand
white rabbit
g. Acute Intravenous toxicity study of Erythropoetin in Swiss Albino mice
h. Acute intravenous toxicity study of Erythropoetin in New Zealand white
rabbit
Clinical Studies i.
Bioequivalence study of rh-Erythropoetin alfa and Eprex in healthy Thai
male volunteers.
ii. Open label, multicentric, non-comparative clinical trial to assess the efficacy
and and safety of erythropoietin manufactured by M/s Gennova
Biopharmaceuticals in the treatment of anemia of chronic kidney disease. (
M/s Gennova Biopharmaceuticals Limited, India declared that their clinical
trial data is non-comparative in nature. Product got approval in 2006 and at
that time guidelines were not available to perform comparative clinical
study.)
Decision: Registration Board deferred the products for following by the firm:
a. Confirmation of approval date of finished product of bulk manufacturer in country of
origin.
b. Submission of data regarding physicochemical characterization and biological activity in
comparison with innovator product.
Case No.05: Miscellaneous/ Deferred cases
a. Anflu vaccine 0.5ml PFS approved in 256th meeting of Registration Board.
Following product of M/s Sind Medical Store, Karachi was approved in 256th meeting of
Name of Brand Name & Brand Name & Decision of RB in 256th
Manufacturer Composition as per Composition as per CoPP meeting
minutes of meeting
Bulk Manufacturer: ANFLU 0.5ML PFS ANFLU 0.5ML PFS RegistrationBoard
M/s Sinovac Biotech Influenza Vaccine Influenza Vaccine approvedthe product
Co., Ltd., (Split Version), (Split asper ImportPolicy for
No. 39 Shangdi Xi Inactivated;Injection Version),Inactivated;Injection Finished Drugs.Latest
Road, Haidian District, Each dose 0.5ml Each dosecontains: strain as
Beijing contains: NYMC X-179Areassortant per WHOnotification
Formulation, Filling NYMC X-179A derived shallbe adopted andwill
& Packaging: reassortant derived fromA/California/7/2009 informRegistration
M/s Sinovac Biotech from ………..15μg/0.5ml Boardaccordingly.
Co., Ltd., A/California/7/2009. NIB-88 reassortantderived
No. 15 Zhi Tong Road, ………….15μg from
Changping Science NIB-88 reassortant A/Switzerland/9715293/
Park, Changping derived from 2013
District, Beijing A/Switzerland/9715 ………. …….15µg/0.5ml
293/ 2013…….15μg B/Phuket/3073/2013…15μg/
B/Phuket/3073/2013 0.5ml
…….15μg
In minutes of 256th meeting, Anflu vaccine 0.5ml PFS is inadvertently written as “Split
Version” while as per CoPP and other documents it is “Split Virion”. Therefore, as per practice
registration lettershave been issued with composition as per CoPP.
Decision: Registration Board acknowledged the information.
b. Request of inspection exemption applied by M/s Vet Crown (Animal health)
International, Lahore for their already approved products deferred in 279th meeting of
Registration Board.
Following products of M/s Vet Crown (Animal health) International, Lahore were approved in
274th meeting of Registration Board. The details are as under:
S.#. Name of Name of Drug and Composition Documentary Decision of
th
Manufacturer details 274 meeting
of RB
1 M/s BIAROMVAC-PA Legalized COPP Keeping in
S.C Romvac Infectious Bursal Disease (IBD) NO. 930/3 dated view the
Company S.A, 28.9.2015 recommendatio
SoseauaCenturii Each dose contains Active substance: n of veterinary
nr.7,077190Vol Live IBD virus attenuated strain (PA 43- Market authorization expert,
untari, Jud. 94) contain minimum 103.5Eid 50 to no. 120170 dated 17- Registration
llfov-Romania. maximum 105.5Eid 50. 5-2012 Board approved
the products as
Pharmacological group: GMP Certificate No. per valid
Vaccine (Lypholized). 29/2013/RO dated legalized CoPP
17-12-2013 subject to
Route of Adm: Ocular conjuctival, IM, compliance of
Oral current Import
Shleflife : 18 months Policy for
2 AVIPOX-GAL Legalized COPP No. finished drugs.
(Avian pox disease vaccine) 930/7/28 dated 28-9-
2015
Each vaccinal dose (0.01ml) contains:
The Avian pox virus-Galinar attenuated Market authorization
strain No. 120010 dated
Gal-MP1with minimum titre 102 and 17-1-2012.
maximum titre 105 DIE50 / Vaccinal dose.
GMP Certificate No.
Pharmacological group: 29/2013/RO dated
Vaccine (Lyophilized). 17-12-2013
Shelf life: 18 months

Route of adm: transdermal
The above manufacturing site has already been inspected on 22-23th August 2017 by panel of inspectors
ShaikhFaqeer Muhammad and Aisha Irfan for following products approved by the Registration Board
in its 258th meeting i.e.
Sr. Name of Brand Name and Composition Decision of 258th

No. Manufacturer meeting of RB
1. M/s S.C AVI PESTIVAC CL 90 Approved as per
RomvacCompany (Lyophilized pellet) import policy
S.A, SoseauaCenturii Each dose contains: and as per valid
nr.7,077190Voluntari, New castle disease virus La Sota strain-CI 90- Min.106EID50 legalized
Jud. llfov-Romania to max.107 EID50
2. OVOPROTECT Approved as per
(Injectable emulsion) import policy
Each dose contains: Suspension of NDV inactivated virus- and as per valid
Lasotastarin ≥ 4 log2 IHA. legalized CoPP
Suspension of BI Inactivated virus-M41 Strain S/P-≥ 0,2 To
ELISA test.
Suspension of EDS 76 Inactivated virus-≥ 3log2 IHA
3. TIFOROMVAC. Approved as per
(Lyophilized pellet) import policy
Each dose contains: Salmonella gallinarum-9R attenuated and valid
strain suspension of live germs Min.2 x107 UFC- Max.2 x108 legalized CoPP
UFC.
The panel rated the facility as “GOOD” and recommended the facility. Therefore, in light of above
panel inspection report and decision of Registration Board in its 262nd meeting, the exemption of
inspection of above products may be granted.
The case was taken up in 279th meeting of registration Board wherein the Board decided as follows:
“Registration board deferred the request of the firm. The DBER is advised to evaluate the
manufacturing processes of applied vaccines and the vaccines for which inspection has been
conducted in terms of method and facility.”
The outline method of manufacturing of above vaccines is as follows:
Biaromvac-PA Avipox-Gal Avipestivac CL 90

i. Reception of embryonated i. Reception of embryonated i. Reception of embryonated
eggs eggs eggs
ii. Egg candling of the ii. Egg candling of the ii. Egg candling of the
embryonated eggs embryonated eggs (by embryonated eggs
iii. Preparation of inoculums ovoscope) iii. Preparation of inoculums
and embryonated egg iii. Preparation of inoculums and embryonated egg
inoculation and embryonated egg inoculation
iv. Harvesting and flow control inoculation iv. Harvesting and flow control
of avian infectious virus iv. Sampling and control of the of the viral suspension
suspension viral suspension- WS-Gal- NDV-TL La Sota-Cl-90
v. Virus suspensions merging MP1 v. Merging to flask of the vials
(triturated of hen’s v. Pulling in the bulk balloon with viral suspension and
embryos, corioallantoidian the vials containing the creating the batches of
membranes, virus suspension (triturate vaccine.
allantoamniotic fluid and of chorioallantoic vi. Distributing the vaccine
batch formation) membranes) for the vaccine suspension into vials for
vi. Distributing the vaccine series constitution. lyophilization
suspension into vials for vi. Distributing the vaccinal vii. Vaccine lyophilization
lyophilization suspension into bottles for viii. Labelling and vaccine
vii. Vaccine lyophilization lyophilization packaging
viii. Labelling and vaccine vii. Vaccine lyophilization
packaging viii. Labelling and vaccine
packaging
Decision: Keeping in view the recommendation of veterinary expert and inspection report of
panel of inspectors dated 22nd-23rd August, 2017 as recorded above, reflecting that
facility was inspected at that time for same category of products and falls within
the time span of five years in accordance with procedure adopted in 262nd meeting
of Registration Board, hence the Board acceded to the request of the firm for
exemption of inspection of manufacturing facility i.e. M/s S.C Romvac Company
S.A, Soseaua Centurii nr.7,077190 Voluntari, Jud. llfov-Romania for above
products as per inspection in light of Import Policy for Finished Drugs.
c. Exemption of Inspection of Eporon PFS 2000IU and 4000IU approved in 275th meeting of
Registration Board applied by M/s Shamco Traders (Pvt.) Ltd., Lahore.
M/s Shamco Traders (Pvt.) Ltd., Lahore applied for the exemption of inspection of their
imported human biologicals approved in 275th meeting of Registration Board as per following details:
Sr. Name of Manufacturer Brand Name & Composition Decision of RB in

No. 275thmeeting
1. M/s Dong-A ST Co., Ltd. Eporon PFS 2000IU/0.5ml Keeping in view the
(Dong-A Pharmaceutical biosimilarity data and valid
Co., Ltd. Before Split-Off Each 0.5ml contains: legalized CoPP provided by the
on March 5th, 2013) Recombinant human firm; Registration Board
(N-dong, B-dong Section erythropoietin…..2000IU approved the product subject to
2. 2) 493 Nongong-ro, Eporon PFS 4000IU/0.4ml price fixation by the Federal
Nongong-eup, Dalseong- Government and compliance of
gun, Daegu, Republic of Each 0.4ml contains: current Import Policy for
Korea Recombinant human Finished Drugs.
erythropoietin…….4000IU
Now, the firm has submitted that DRAP has already visited their manufacturing facility.
In this context, it is submitted that the aforementioned manufacturing facility has already been
inspected by following panel of inspectors dated 04th to 05th December, 2017:
i. Dr. Noor-us-Saba
ii. Mr. Abid Hayat
The facility was inspected for following products:
a. Gonadopin NF Inj. PFS 75IU/0.25ml (Recombinant Follicle Stimulating Hormone)
b. Gonadopin NF Inj. PFS 150IU/0.5ml (Recombinant Follicle Stimulating Hormone)
c. Gonadopin NF Inj. PFS 300IU/ml (Recombinant Follicle Stimulating Hormone)
The panel “Recommended” the facility and rated “Very Good”.
Decision: Keeping in view the inspection report of panel of inspectors dated 04 th-05th
December, 2017 as recorded above, reflecting that facility was inspected at that
time for same category of products and falls within the time span of five years in
accordance with procedure adopted in 262nd meeting of Registration Board, hence
the Board acceded to the request of the firm for exemption of inspection of
manufacturing facility i.e. M/s Dong-A ST Co., Ltd. (Dong-A Pharmaceutical Co.,
Ltd. Before Split-Off on March 5th, 2013) (N-dong, B-dong Section 2) 493 Nongong-
ro, Nongong-eup, Dalseong-gun, Daegu, Republic of Korea for above product as
per inspection in light of Import Policy for Finished Drugs.
d. Shelf Life inclusion in initial registration letters of veterinary vaccines applied by M/s
Hilton Pharma (Pvt.) Ltd., Karachi.
M/s Hilton Pharma (Pvt.) Ltd., Karachi applied for the inclusion of shelf life in registration
letters of their already registered vaccines. The details of the vaccines are as follows:
Sr. Reg. Brand Name & Composition Date of Initial Date of Last Demanded
No. No. Registration Renewal shelf life
1 033206 Medivac Coryza T Emulsion Vaccine 11-11-2004 22-07-2014 18 months
Each dose contains:

Inactivated Haemophilus paragallinarum
of W strain not less than 108CFU
of Spross strain not less than 108CFU
of Modesto strain not less than 10SCFU.
2 033207 Medivac ND-EDS Emulsion Vaccine 11-11-2004 22-07-2014 18 months
Each dose contains:

Inactivated Newcastle Disease Viruses of
La Sota strain not less than 50PD50
Inactivated adenovirus of 127Mc Ferran
strain not less than 1000HA unit.
3 033208 Medivac ND-IB Vaccine 11-11-2004 22-07-2014 24 months
Each dose contains:

Freeze-dried live ND viruses of Clone 45
strain ≥106.5EID50 and
IB viruses of H-120 Massachusetts strain
≥ 103.5 EID50
4 033209 Medivac ND Clone 45 Vaccine 11-11-2004 22-07-2014 24 months
Each dose contains:

Freeze-dried live ND viruses of lentogenic
Clone 45 strain ≥ 107 EID50
5 033210 Medivac ND La Sota Vaccine 11-11-2004 22-07-2014 24 months
Each dose contains:

Freeze-dried live ND viruses of La Sota
strain ≥ 107EID50
6 033211 Medivac ND Emulsion Vaccine 11-11-2004 22-07-2014 18 months
Each dose contains:

Inactivated Newcastle Disease Viruses of
La Sota strain not less than 50PD50
7 033212 Medivac ND Hitcner B1 Vaccine 11-11-2004 22-07-2014 24 months
Each dose contains:

Freeze-dried live ND viruses of Hitchner
B1 strain ≥ 107 EID50
8 033213 Medivac IB H-120 Vaccine 11-11-2004 22-07-2014 24 months
Each dose contains:

Freeze-dried live IB viruses of H-120
Massachusetts strain ≥ 103.5 EID50
The firm has submitted following documents:
i. Fee Challans of Rs. 5000/- for each product
ii. Copies of initial registration letters
iii. Copies of last renewal submissions for each product
iv. Real time stability data of 3 batches for each product
v. Valid legalized CoPP for each product issued by Ministry of Agriculture, Directorate
General of Livestock and Animal Health Services, Indonesia indicating claimed shelf lives
of aforementioned vaccines.
Renewal submissions of the products have been verified from RRR section.
Decision: Registration Board acceded to the request of the firm and approved the shelf lives
as per following details:
Sr. Reg. Brand Name & Composition Demanded

No. No. shelf life
1 033206 Medivac Coryza T Emulsion Vaccine 18 months
2 033207 Medivac ND-EDS Emulsion Vaccine 18 months
3 033208 Medivac ND-IB Vaccine 24 months
4 033209 Medivac ND Clone 45 Vaccine 24 months
5 033210 Medivac ND La Sota Vaccine 24 months
6 033211 Medivac ND Emulsion Vaccine 18 months
7 033212 Medivac ND Hitcner B1 Vaccine 24 months
8 033213 Medivac IB H-120 Vaccine 24 months
e. Allotment of separate registration numbers for Epokine 2000IU/0.5mL PFS/ Vial

(023635)& 4000IU/0.4mL PFS/ Vial (023633) applied by M/s RG Pharmaceutica (Pvt)
Ltd., Karachi deferred in 264th meeting of Registration Board.
M/s RG Pharmaceutica (Pvt.) Ltd., Karachi applied for the allotment of separate registration
numbers for their already registered products Epokine 2000IU/0.5mL PFS/ Vial (023635)&
4000IU/0.4mL PFS/ Vial (023633). The firm submitted that at the time of registration of Epokine
2000IU and 4000 IU vial and prefilled injection, the concerned section issued one registration number
for both products. The firm requested to issue separate additional registration No. for Epokine 2000
&4000 IU vials. The firm further requested to issue that along with the brand name generic/
composition as per CoPP may kindly be mentioned which is not incorporated in initial registration
letter. The case was initially discussed in the 264th meeting of Registration Board wherein the board
decided as under:
S.#. Reg. Name of Brands Name Pack Size & Documentary Decision of RB in
No. Manufacturer &Composition Price as per details 264th meeting
Registration
Letter
1 023635 M/s CJ Epokine Prefilled Valid Registration Board
HealthCare syringe/ Vial Legalized deferred request of
Corporation, Each dose Rs. 995/- CoPP No. the firm for allotment
811,Deokpyeon contains: 2014-A1-1583 of separate
gro, Recombinant 1 x 6’s Pre- dated 03-09- registration numbers
Human filled syringes 2014 for PFS. for Epokine
Majangmyeon,l Erythropoietin… in cardboard 2000IU/0.5mL PFS/
cheon-si, ...2000Units box. Valid Vial (023635) &
Gyeonggi- Price not Legalized 4000IU/0.4mL PFS/
do,Korea. mentioned in CoPP No. Vial (023633) and
letter. 2014-A1-1578 advised to provide
dated 03-09- the current MRP
2014 for Vial. along with import
2 023633 M/s CJ Epokine Prefilled Valid status of aforesaid
HealthCare syringe/ Vial Legalized products since
Corporation, Each dose Rs. 2000/- CoPP No. registration.
811,Deokpyeon contains: 2014-A1-1576
gro, Recombinant 1 x 6’s Pre- dated 03-09-
Majangmyeon,l Human filled syringes/ 2014 for PFS.
cheon-si, Erythropoietin… Vials in
Gyeonggi- ...4000Units cardboard box. Valid
do,Korea. Price not Legalized
mentioned in CoPP No.
letter. 2014-A1-1579
dated 03-09-
2014 for Vial.
The firm has submitted required documents as per the decision of Registration Board and it was
observed that the firm was granted pack of 6’s while the pack of 10’s was not approved to import. The
case was again teken up in 276th meeting of registration board wherein the Board decided as follows:
“Registration Board referred the case to QA & LT Division for their comments regarding the
import of pack size 10’s without registration.”
The response of QA&LT Division was received vide Dy. No. 353-DD/(QC) which includes a letter
vide No. F. 01-04/2018-DRAP(K) dated 24-05-2018 from DRAP office, Karachi. The details of the
letter are as follows:
“ The import of Epokine Vials 2000IU and 4000IU in pack of 1x10 by RG Pharmaceutica and
its release by our department is granted on following grounds:
i. That with each release the firm has submitted this office the initial registration letter and
amended note that showed that the firm possesses the registration of PFS and Vials under one
registration with approved MRP of individual unit along with pack size of 1x6 per pack.
ii. That while clearing the case it was kept in mind that even after the pack size minor variation,
the MRP of single unit (Vial) would not be affected as per the condition of registration letter.
iii. Upon that variation the firm replied that the same is being done keeping in view the
international availability in the same pack size, stability of drug and facilitation in
transportation of goods.
Based on the above facts it is the understanding of this office that as both the two put us of
Epokine Vial 2000IU and 4000IU are registered and lawfully approved by MOH vide its letter
dated 20th October 1999. The said letter includes the rectification note as well that due to
oversight the vials has not been mentioned in the registration letter dated 26-05-1999. It further
endorsed that the packing should have to be corrected accordingly. Rests of the variance/
conditions were kept same. Secondly, the package inserts as available with each imported pack
mentioned the detail about presentation as follows:
Epokine Prefilled Injection
1000units/2000units/3000units/4000units/10000units carton of 6 syringes.
P.T.O
Epokine Injection Vial
2000units/4000units/10000units carton of 10 vials
And most important that MOH has awarded per unit price in registration letters
irrespective of pack size.
It is observed that the RG Pharmaceutica imported both drugs Epokine 2000IU and Epokine
4000IU Vials after obtaining approval from MOH and as per presentation available in country of
origin i.e. prefilled syringes dosage form are available as 1x6’s pack only while put ups of Epokine in
Vial dosage forms as 1x10’s pack size only.
Therefore matter in question related to pack size (1x10’s) of Epokine 2000IU and 4000IU
appears to be a typographical error or missing in the initial MoH letter and not a violation against
any of the provision of Drugs Act 1976 and Rules framed there under because it doesn’t affect the
quality, potency and MRP of the drug in question at any cost. Therefore, it is recommended that DRAP
may rectify the initial conditions of the registration letter by granting the firm a separate registration
for PFS and Vials along with proper pack size for individual put ups.”
Discussion:
Epokine Injection 2000IU and 4000IU were initially registered in 1’s and 6’s PFS on 26-05-1999 with
MRP of only 1’s packing. The firm was then granted vials packing with the same registration number
as of PFS. Since registration, M/s RG Pharmaceutica is importing Epokine Injection 2000IU & 4000IU
in 1’s & 6’s PFS and 1’s & 10’s vials. M/s RG Pharmaceutica (Pvt.) Ltd., Karachi was called for
personal hearing before Registration Board regarding the import of pack size of 10’s vials while they
have been granted registration of 6’s vials. Mr. Safdar (Compliance Manager) on behalf M/s RG
Pharmaceutica (Pvt.) Ltd., Karachi informed the Board that since registration they are importing pack
size of 10’s vials and selling individual vials as the MRP is only fixed for 1 vial. He further informed
that the same pack size is available in country of origin and also presented the pack presentations of
1x6’s PFS and 1x10’s Vials.
Decision: Registration Board advised the firm to Import Epokine injection 2000IU and
4000IU as per registration letter and comply Drugs (Labelling and Packing) Rules,
1986. The Board deferred firm’s request for allotment of separate registration
numbers for Epokine 2000IU/0.5mL PFS/ Vial (023635)& 4000IU/0.4mL PFS/ Vial
(023633) for further deliberation.
f. Cancellation of Registration applied by M/s Roche Pakistan Limited, Karachifor their

already registered human biologicals Mircera Injection 250mcg PFS (Reg. No. 059047)
&Mircera Injection 800mcg PFS (Reg. No. 059046).
M/s Roche Pakistan Limited, Karachi applied for the cancellation of Registration of their
already registered products. The details of the products along with their renewal status are as under:
Brand Name, Date of Initial Date of Last Alternative Justification of
Composition& Reg. No. Registration Renewal Brands Cancellation
Mircera Injection 250mcg 02-09-2009 28-08-2014 No Brand as Not suitable to market
Pre-filled Syringe per our as per our local
(Reg. No. 059047) record. demographics of people
with lower body eight.
Each 0.3ml contains: Therefore, Mircera
Methoxy polyethylene 250mcg was
glycol-epoetin discontinued.
beta.......250mcg
Mircera Injection 800mcg 02-09-2009 28-08-2014 No Brand as Not suitable to market
Pre-filled Syringe per our as per our local
(Reg. No. 059046) record. demographics of people
with lower body eight.
Each 0.6ml contains: Therefore, Mircera
Methoxy polyethylene 800mcg was
glycol-epoetin discontinued.
beta...........800mcg
Decision: Registration Board deferred the case for following:

a. Already registered brands
b. Therapeutic Indications and dosage
g. Application for registration of Additional pack 1’s x 3ml of already approved product
Xultophy applied by M/s Novo Nordisk Pharma (Private) Limited, Karachi.
M/s Novo Nordisk Pharma (Private) Limited, Karachi applied for the approval of additional
pack (1’s x 3ml) of their already approved product Xultophy.
In this context, it is submitted that initially the firm has applied only for 3’s x 3ml and 5’s x 3ml
pack sizes which were approved in 262nd meeting of Registration Board as per following details:
Name of Brand Name & Pack Size & Document Details Decision of RB in
Manufacturer composition Demanded Price 262nd meeting
M/s Novo Xultophy 3x 3ml Legalized CoPP No. Keeping in view the
Nordisk A/S 5x 3ml 06/16/98682 EMA approval,
Novo Alle One prefilled pen Price: Will be Dated Registration Board
DK-2880 contains: submitted later. 18-05-2016 from approved the product
Bagsvaerd Insulin degludec….. European Medicine as per Import Policy for
Denmark ......300Units Agency Finished Drugs and as
Liraglutide…….......... per valid legalized
...10.8mg CoPP.
Shelf life: 2years
Accordingly, the case was referred to pricing division for Price fixation but the price has not yet been
notified. Now, the firm has submitted application for registration of additional pack of 1’s x 3ml and
submitted the following documents:
a. Fee Challan of Rs. 5000/-
b. Copy of CoPP No. 06/16/98682 dated 18-05-2016 issued by EMA submitted with initial
application indicating desired pack size i.e. 1’s x 3ml (original is attached with initial
application which is available in division).
Decision:
Being the preview of Costing & Pricing Division, Registration Board did not accede to the
request of the firm.
h. Binocrit 1000IU/0.5ml PFS applied by M/s Novartis Pharma, Karachi approved in 253rd
meeting of Registration Board.
Following product of M/s Novartis Pharma (Pakistan) Limited, Karachi was approved in 253rd
meeting of Registration Board as per following details:
Name of manufacturer Brand Name & Brand Name & Decision of RB
Composition as per composition as per CoPP in 253rd
minutes meeting
Product License Holder: Binocrit Binocrit Approved
M/s Sandoz GmbH, 1000IU/0.5mlPFS Solution for injection in a
Biochemiestrasse 10, A-6250 Epoetin Alfa prefilled syringe
Kundl, Austria
Manufacturer: Each 0.5ml contains:
M/s IDT Biologika GmbH, Am Epoetin alfa……
Pharmapark, D-06861 Dessau- ….1000IU
Rosslau, Germany.
In this context, it is submitted that in minutes of 253rd meeting of Registration Board composition of
above product was not mentioned. However, as per practice Registration letters will be issued as per
composition mentioned in CoPP.
i. 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 Syringe 1 vial of powder + 1 PFS of
Inactivated Rabies vaccine diluent
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. The case was taken up in 281st meeting of registration Board
wherein the Board decided as follows:
“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.”
Discussion: Verorab vaccine was initially registered on 25-03-1987 with pack presentation of
“single dose syringe” while Verorab is actually imported since transferred / registered to M/s Sanofi-
Aventis Pakistan Limited, Karachi in combo pack as “1 vial of powder + 1 PFS of diluent (0.4%
NaCl)”. M/s Sanofi-Aventis Pakistan Limited, Karachi was called for personal hearing before
Registration Board regarding the clarification of aforementioned pack presentation. Ms. Maryam
Saleem, Assistant Manager Regulatory Affairs on behalf of M/s Sanofi Aventis Pakistan Limited,
Karachi appeared before the Board and informed that they are importing Verorab in combo pack i.e. 1
vial of powder + 1 PFS of diluent since transferred in their name. Registration Board deliberated that
the initial registration was for single dose syringe and the packing imported is also single dose and its
diluent is coming in PFS as combo pack.
Decision: Registration Board acceded to the request of the firm and advised to issue
corrigendum as per following details:
Reg. No. Name of Drug Pack Size as per Newly Approved Pack
initial Reg. letter size
009519 Verorab Single Dose Syringe 1 vial of powder + 1 PFS of
Inactivated Rabies vaccine diluent (0.4% NaCl)
j. Non-availability of Veterinary Biological drugs in country of origin

Biological division has come across such cases where the firms submitted CoPP which indicating the
product’s non-availability in country of origin. The firms were asked to submit clarification and the
new CoPP submitted indicated that the products are unavailable because the disease is not endemic in
country of origin. All such cases are summarized as under;
Sr. Manufacturer/ Brand Name and Composition Remarks Registration Status
No. Importer Board decision
1. M/s. Ghazi IzovacAviflu 9 Multidose Freeze- New CoPP 273rd Approved
Brothers, Dried Bottle mentions that "Keeping in view
Karachi. Each dose of 0.5ml of vaccine "The product the facts recorded
contains:- has been above and GMP
M/s. IZO S.p.A., developed confirmation by
Via Inactivated Avian Influenza A strain exclusively for Italian regulatory
A. Bianchi 9, H9N2………320 H.A.U. the treatment authority,
Brescia, Italy. (Immunological) of the Registration Board
(For Veterinary Use). conditions approved the
particularly product as per
tropical valid legalized
diseases, not CoPP and subject
endemic in the to compliance of
country of Import policy for
export" Finished Drugs".
2. M/s Forward Olvac A+B+G New CoPP 282nd Deferred
Solutions (Oil emulsion for Injection) mentions that "clarification
(Animal Health "The product regarding non
Company), 67 Each dose contains: has been availability of
West Wood Inactivated Newcastle disease developed product in country
Society, Main virus….not less than 50PD50 exclusively for of origin as per
Canal Road, Inactivated infectious bronchitis the treatment submitted
Lahore virus…not less than 10 EID50
7.5
of the
Inactivated EDS ’76 conditions- CoPPs"(Draft
Product License Adenovirus…not less than particularly minutes)
Holder: 1000HAU tropical
M/s FATRO Inactivated IBD virus…not less than diseases- not
S.p.A, 106.5EID50 endemic in the
Via Emilia, 285- Olvac B+G+R country of
40064 Ozzano (Oil emulsion for Injection) export."
Emilia (BO)
Italy Each dose contains:
Manufacturer: Inactivated Newcastle disease
M/s FATRO virus….not less than 50PD50
S.p.A, Inactivated infectious bronchitis
in Via Molino virus…not less than 107.5EID50
Emili, 2-25030 Inactivated IBD virus…not less than
Maclodio(BS) 107.0TCID50
Italy Inactivated Avian Reovirus…..not
less than 107.0TCID50
Ai-Vac H9
(oil emulsion for Injection)
Each dose contains:

Inactivated avian influenza virus
(H9N2 strain)…not less than
107.5EID50
3. M/s Saadat GALLIMUNE MG New CoPP 281st Deferred
International (inactivated vaccine in oil adjuvant mentions that Registration Board
Lahore. against deferred the case
Mycoplasma gallisepticum "Formulation/ and advised DBER
Merial Italia infections of poultry) combination of to bring the
S.p.A Via Each dose of 0.3 ml contains: the product is comparison in next
Baviera 9 Mycoplasma gallisepticum, strain S6 not required Registration Board
35027 inactivated minimum titre before for the local meeting with
NoventaPadova inactivation 109 CFU. market as it is already approved
na (PD) Italy Active Immunization of healthy specially such cases.
breeding and laying stock against formulated to
mycoplasma. meet the
GALLIMUNE 403 importing
ND+IB+IBD+REO country
(Inactivated vaccine in oil adjuvant requirement"
against New castle disease ,
Infectious bronchitis, Infectious
bursal disease and Avian
viralArthritis).
Each dose of 0.3 ml contains:-
Newcastle disease virus
(Ulster 2C strain),
inactivated, minimum titre before
inactivation 108 EID50
Infectious bronchitis virus (Mass
41strain),
inactivation 106.7 EID50
Infectious bursal virus
(VNJO strain), inactivated,
minimum titre before inactivation
105.7CCID50
Avian viral arthritis
reovirus (S1133 strain),
inactivation 107 CCID50
Avian viral Arthritis
GALLIMUNE ART
(Inactivated vaccine in oil adjuvant
against
Infectious Avian
Rhinotracheitis
Each dose of 0.3ml contains:

Avian Rhinotracheitis
virus, VCO3 strain,
inactivated, at least 60IPU
Active immunizationof laying and
breeding stocks against avian
rhinotractitis
4. M/s Saadat GALLIVAC REO

International (Live freeze dried vaccine against
Lahore. avian
viral arthritis)
License
holder: Each dose of 0.2 ml contains:
Merial Italia Avian arthritis reovirus, S1133 strain,
S.p.A Via at least
VittorPisani 16 104TCID50
20124 Milano
Manufacturer:
IZO S.r.l. a
socio unico,
StradaStatale
234 Km 28200,
27013 Chignolo
PO Italy
Decision: Registration Board referred the case to expert working group on veterinary drugs.
k. Exemption of Inspection applied by M/s Amson Vaccine & Pharma (Pvt) Ltd, Islamabad.
Following product of M/s Amson Vaccine & Pharma (Pvt) Ltd, Islamabad was approved in 278th
meeting of Registration Board wherein the board approved the product and decided as under;
Name of Brand Name & Composition Document Registration
Importer & details Board decision
Manufacturer (CoPP)
M/s FLUART 3Fluart Suspension for Injection Legalized Keeping in view

Innovative Infuenza vaccine (whole virion, inactivated, adjuvated)
CoPP No. valid legalized
Vaccines Kft. OGYEI/6560 CoPP;
(FluartInnovativ One dose of vaccine (0.5ml) contains: 1-2/2017 Registration Board
e Vaccines Ltd), A/Michigan/45/2015 (H1N1) pdm09–like strain dated approved the
2097 (A/Michigan/45/2015, NYMC X-275) ………….6 mcg 20/11/2017 product subject to
Pilisborosjeno, HA price fixation by
Fo u 7. Hungary. A/Hong Kong/4801/2014 (H3N2)–like strain (A/Hong the Federal
Kong/4801/2014, NYMC X-263B) ... ……6mcg HA Government and
B/Brisbane/60/2008 – like strain (B/Brisbane/60/2008, compliance of
NYMC BX-35) ………….…6 mcg HA current Import
Policy for Finished
Shelf life: 15 months Drugs
Now, the firm has requested for inspection exemption and submitted that
"The Principal Company M/s FLUART Innovative Vaccines has manufacturing unit in the European
country i.e. Hungry. The said product is also included in suppliers of NATO SUPPORT AND
PROCUREMENT AGENCY.
The flu vaccine of this company has been exported to various other countries of South East Europe i.e.
Republic of Maldova& Albania"
The firm has submitted following documents;
i. Copy of document of NATO SUPPORT AND PROCUREMENT AGENCY
(which mentions bid for year 2016)
ii. Copy of letter from the manufacturer mentioning the countries where the vaccine
is exported (also include Republic of Maldova& Albania)
Decision: Registration Board advised M/s Amson Vaccine & Pharma (Pvt.) Ltd., Islamabad
to apply for inspection exemption in light of current Import Policy for finished
drugs.
l. Free sale of veterinary product in country of origin applied by M/s Mustafa Brothers,
Faisalabad
Following product of M/s Mustafa Brothers, Faisalabad was discussed in 269th meeting of
Registration Board wherein the board decided as under;
Name of Importer & Brand Name & Composition Document Registration
Manufacturer details Board Decision
(CoPP)
M/s Mustafa Brothers ARRIAH PPRV Legalized Registration

186-D, Peoples Colony No. 1, (Virus vaccine against PesteDesPetitis GMP Board approved
Faisalabad Ruminants Cultural Dry) certificate the product as per
The Virus vaccine against PesteDesPetitis No. 01025 import policy for
Ruminants Cultural Dry contains Peste dated 17-09- finished drugs
M/s Federal Governmental Des Petitis Ruminants virus of 2015 valid till and as per valid
Budgetary Institution “Federal “ARRIAH” strain. 17-09-2018 legalized GMP &
Centre for Animal Health” Each inoculating dose contains: Free sale
(FGBI”ARRIAH”) PPRV vaccine strain “ARRIAH” not less Legalized certificate.
600901, Russia, Vladimir than 1000TCID50. FSC dated
region, Vladimir, 24-09-2016
microrayonYur’ evets
It is submitted that GMP inspection of manufacturing facility abroad is done.Report is rated as “very
good” while general remarks of report are as under;
“Firm has very well established, maintain manufacturing and quality control facilities for applied
products. Technical staff was professionally fully competent to perform their function. It is an
excellent unit / organization. Research and development to forecast disease pattern in Russia and
neighboring countries is remarkable function of this organization. PPR vaccine is result of this
research and it has been developed due to prevalence of targeted disease in neighboring countries.
It is currently not marketed in Russia due to non existence of disease in Russia”.
However, it is to mention that firm has provided free sale certificate for its product “ARRIAH PPRV”
while above mentioned remarks describes that it is currently not marketed in Russia. The firm was
asked for clarification regarding availability of product in country of origin for different statements on
free sale certificate and inspection report.In reply, the firm has provided Certificate of the Veterinary
Preparation from Ministry of Agriculture of the Russian Federation. Justification provided is
reproduced as under;
“This is to certify that this preparation is manufactured and its free sale is permitted in the Russian
Federation and is exported to foreign countries in accordance with the laws of this country. The
product was registered by Rosselhoznadzor, the registration certificate of the medicinal
preparation for veterinary use.
ARRIAH PPRV “Virus Vaccine Against PesteDes Petits Ruminants Cultural Dry” is being
manufactured by the Federal Governmental Budgetary Institution “Federal Centre for Animal
Health” (FGBI “ARRIIRRIAH”) for the prevention of PPR disease from the Russian region. Since
Russia was declared as PPR free country, the vaccine is not available in the local market, but for
few continents bordering with other countries like Belarus, Ukraine, Georgia, Azerbaijan,
Kazakhstan, Mongolia, North Korea and China, Federal Governmental Budgetary Institution
“Federal Centre for Animal Health” (FGBI “ARRIAH”) is producing the above mentioned
vaccine as per the Government of Russia requirement for emergency use to prevent the Russia
from PPR disease.”
Decision: Registration Board referred the case to expert working group on veterinary drugs.
m. Deferred human biological products applied by M/s Eastern Trade & Distribution Co.
(Pvt.) Ltd Karachi:
Following human biological products were applied by M/s Eastern Trade & Distribution Co.
(Pvt.) Ltd Karachi and deferred in 276th meeting of registration board with details as under;
1. Name of Importer The Eastern Trade & Distribution Co. (Pvt.) Ltd., 507-510, 5th
Floor Commerce Centre HasratMohani Road, Karachi
Name of Manufacturer M/s Biotest Pharma GmbH, Landsteinerstraβe 5, D-63303, Dreieich,
Germany
Brand Name +Dosage Form + Fovepta
Strength Solution for injection
Composition Each ml solution for injection contains:
rd
607
Human protein 150mg of which at least IgG 96% with a content of
antibodies to HBs antigen 500IU
Distribution of IgG subclasses:

59% IgG1, 35% IgG2, 3% IgG3, 3% IgG4.
IgA content max. 6mg/ml.
Finished product specifications Ph. Eur. Specs
Approval status of this product in Germany
Reference countries
Pharmacological Group Human Hepatitis B Immunoglobulin
Shelf life 24 months (2-80C)
International Availability of this Germany
product
Similar Product already registered
in Pakistan
Dy No & Date of application, Dy. No. 19563 dated 31-10-2017
Fee submitted Rs. 100000/-
30-10-2017
Demanded Price/ Pack size 1’s PFS (0.4ml)/ Rs. 28800/-
General documentation Valid Legalized CoPP No. KABQ 8 dated 08-02-2017 issued by
Germany.
Newly Submitted valid legalized CoPP No. KACR4 dated 26-03-
2018.
Decision of RB in 276th meeting Registration Board deferred the application for the submission of
following by the firm:
i. Clarification regarding the submitted CoPP and letter of
authorization as they indicate that the validity of attestation is 120
days only.
ii. Clinical trial data of Fovepta OR scientific and regulatory
justification of approval of Fovepta in country of origin.
iii. Accelerated and real time stability data of 3 batches.
Remarks of Evaluator: The firm has submitted the following documents:
a. Clarification which indicates that 120 days attestation means the
documents should reach in 120 days. However, the documents
were also not submitted within 120 days. Now, the firm has
submitted new CoPP which do not mention such condition.
b. Accelerated and real time stability data of 3 batches.
c. The firm has submitted an open prospective single arm study
investigating efficacy and safety of the human hepatitis B
immunoglobulin BT088 after subcutaneous application in liver
transplanted patients.
d. Summary of clinical safety of Fovepta for SC and IM
administration immunoprophylaxis of Hepatitis B in the Newborn
of a Hepatitis B virus carrier-mothers.
Decision: Registration Board deferred the case for submission of clinical trial data by the firm.
Germany
Brand Name +Dosage Form + Hepatect CP
Strength Solution for infusion
Composition Each ml solution for infusion contains:
Human plasma proteins 50mg thereof immunoglobulin G ≥96% with
antibodies to HBs-antigen 50IU

59% IgG1, 35% IgG2, 3% IgG3, 3% IgG4. The IgA content is limited
to ≤ 2000 micrograms/ml.
Approval status of this product in Austria, Denmark, Germany, The Netherland, United Kingdom
Reference countries
International Availability of this Bulgaria, Croatia, Czech Republic, Greece, Italy, Romania. Portugal
product
in Pakistan
30-10-2017
Demanded Price/ Pack size 1’s Vial (2ml)/ Rs. 14508/-
Germany.
2018.
days only.
ii. Submission of accelerated and real time stability data of 3
batches.
Remarks of evaluator The firm has submitted the following documents:
documents should reach in 120 days. However, the documents
were also not submitted within 120 days. Now, the firm has
submitted new CoPP which do not mention such condition.
Authority); Registration Board approved the product subject to price fixation by the Federal
Government and compliance of current Import Policy for Finished Drugs.
Germany

Reference countries
product
in Pakistan
30-10-2017
General documentation Copy of CoPP No. KABQ 9 dated 08-02-2017 issued by Germany.
Newly Submitted copy of CoPP No. KACR5 dated 26-03-2018.
Decision Registration Board deferred the application for clarification regarding
the submitted CoPP and letter of authorization as they indicate that the
validity of attestation is 120 days only.
Remarks of evaluator The firm has submitted the clarification which indicates that 120 days
attestation means the documents should reach in 120 days. However,
the documents were also not submitted within 120 days. Now, the firm
has submitted new CoPP which do not mention such condition.
Germany

Reference countries
product
in Pakistan
30-10-2017
General documentation Copy of CoPP No. KABQ 9 dated 08-02-2017 issued by Germany.
days only.
ii. Submission of accelerated and real time stability data of 3
batches.
Remarks of Evaluator The firm has submitted the following documents:
documents should reach in 120 days. However, the documents were
also not submitted within 120 days. Now, the firm has submitted
new CoPP which do not mention such condition.
Germany
Brand Name +Dosage Form + Albiomin 5%
Strength Solution for intravenous administration
Composition Each 1000ml solution contains:
Human plasma protein 50g of which albumin at least 96%.
Approval status of this product in United Kingdom, Germany, Denmark, Austria
Reference countries
Pharmacological Group Plasma substitutes and plasma protein fraction
Shelf life 36 months (250C)
International Availability of this Italy, Romania
product
Similar Product already registered Human Albumin Biotest (Reg. No. 008458) of M/s Eastern Trade &
in Pakistan Distribution, Karachi.
30-10-2017
Germany.
2018.
authorization as they indicate that the validity of attestation is
120 days only.
ii. Clinical trial data OR scientific and regulatory justification of
approval of Albiomin 5% in country of origin without clinical
trial data.
iii. Real time stability data of 36 months.
also not submitted within 120 days. Now, the firm has submitted new
CoPP which do not mention such condition.
b. Real time stability data of 3 batches.
c. Documents of European Parliament and of the council which
mentions following “The applicant shall not be required to provide
the results of pre-clinical tests or clinical trials if he can demonstrate
that the active substance of the medicinal product have been in well-
established medicinal use within the community for at least ten
years, with recognized efficacy.
Decision: Registration Board deferred the case for further deliberation in next meeting regarding
the documents of European Parliament and of the council indicating that the applicant shall not be
required to provide the results of pre-clinical tests or clinical trials if he can demonstrate that the active
substance of the medicinal product have been in well-established medicinal use within the community
for at least ten years, with recognized efficacy.
Germany
Approval status of this product in United Kingdom, Germany, Denmark, Austria, Sweden
Reference countries
International Availability of this Italy, Romania, Malta, Cyprus, Bulgaria, Greece
product
Similar Product already registered AlbuRx 20% (Reg. No. 083695) of M/s Hakimsons.
in Pakistan
30-10-2017

Germany.
2018.
days only.
approval of Albiomin 20% in country of origin without clinical
trial data.
b. Documents of European Parliament and of the council which
Germany
Approval status of this product in United Kingdom, Germany, Denmark, Austria, Sweden
Reference countries
International Availability of this Italy, Romania, Malta, Cyprus, Bulgaria, Greece
product
Similar Product already registered AlbuRx 20% (Reg. No. 083695) of M/s Hakimsons.
in Pakistan
30-10-2017

Germany.
i. Clarification regarding the submitted CoPP and letter of authorization
as they indicate that the validity of attestation is 120 days only.
approval of Albiomin 20% in country of origin without clinical trial
data.
b. Documents of European Parliament and of the council which
n. Information regarding incomplete addresses mentioned in approved minutes for

products applied by M/s Eli Lilly Pakistan, Karachi.
The following products of M/s Eli Lilly Pakistan, Karachi were approved in various meetings
of Registration Board as mentioned below. The details of the products are as under;
Sr. Manufacturer Brand Name & Composition Document Details Decision of RB
No.
1. M/s Lilly Basaglar CoPP No. 05/15/89859 M-254th
France,67640 Each unit dose or unit volume Dated 16-7-2015 Keeping in view
Fegersheim, Contains: Prod Reg No. approval status of the
France Insulin Glargine…… EU/1/14/944/001-004 & product by EMA,
100 units/ml 009 Registration Board
(Cartridge) Dated 09-9-2014 Approved as per
Import Policy for
2. Basaglar CoPP No. Finished Drugs and
Each unit dose or unit volume 05/15/89895 confirmation of
Contains: Dated 16-7-2015 storage facility of
Insulin Glargine ……100 units/ml Prod Reg No. EU/1/14/944/ importer.
( Kwikpen) 005-008 & 010-013
dated 09-9-2014
3. M/s LILLY, SA, Cyramza EMA CoPP No. M-256

AVDA DE (Concentrate for solution
for 11/15/92448 Keeping in view
LA infusion) dated 06-10-2015. approval status of the
Industria, 30, Prod Reg No. product by EMA,
28108 Each unit dose or unit volume EU/1/14/957/001, Registration Board
ALCOBEND Contains: Ramucirumab dated 19.12.2014 Approved as per
AS, ….10mg/ml Import Policy for
MADRAID, 1 vial of 10ml Finished Drugs and
4. SPAIN. Cyramza EMA CoPP No. confirmation of
(Concentrate for solution for 09/15/92450 storage facility of
infusion) dated 06-10-2015. importer.
Prod Reg No.
Each unit dose or unit volume EU/1/14/957/003,
Contains: Ramucirumab…… dated 19.12.2014.
10mg/ml
1 vial of 50ml
It is submitted that the complete names of product license holder manufacturer of above products are
not reflected in the minutes of registration Board meetings rather only the address of manufacturer is
mentioned. While on the CoPP of the products primary packaging, batch release and secondary
packaging sites are mentioned as per following format and the Registration letters are being isuued as
per CoPP.
Sr Brand Name & Name & Addressed of Complete Name & Address of manufacturer as per CoPP.
No composition as Manufacturer/License
per CoPP Holder (As reflected in
minutes)
1. Basaglar M/s Lilly Marketing Authorization Holder:
Each unit dose or France,67640 M/s Eli Lilly Regional Operations GmbH, Kolblgasse 8-10,
unit volume Fegersheim, 1030 vienna, Austria.
Contains: France Manufacturer:
Insulin M/s Lilly France, 2 rue du Colonel Lilly, 67640 Fegersheim,
Glargine…… France (Responsible for batch release in EU, quality control,
100 units/ml primary and secondary packaging) AND Hospira, Inc., 1776
(Cartridge) North Centennial Drive, McPherson, Kansas 67460, United
States of America (Also responsible for primary packaging)
2. Basaglar Marketing Authorization Holder:
Each unit dose or M/s Eli Lilly Regional Operations GmbH, Kolblgasse 8-10,
unit volume 1030 vienna, Austria.
Contains: Manufacturer:
Insulin Glargine M/s Lilly France, 2 rue du Colonel Lilly, 67640 Fegersheim,
……100 units/ml France (Responsible for batch release in EU, quality control,
(Kwikpen) primary and secondary packaging) AND Hospira, Inc., 1776
North Centennial Drive, McPherson, Kansas 67460, United
States of America (Also responsible for primary packaging)
M/s Eli Lilly and company, Indianapolis, Indiana 46285,
USA (Responsible for secondary packaging)
3. Cyramza M/s LILLY, SA, Marketing Authorization Holder:
(Concentrate for AVDA DE Eli Lilly Nederland B.V., Grootslag 1-5, NL-3991 RA,
solution for LA Houten, The Netherlands.
infusion) Industria, 30, Manufacturer:
28108 ALCOBEND Eli Lilly and Company, Lilly Corporate Center, Indianapolis,
Each unit dose or AS, Idiana (IN) 46285, USA (also responsible for quality control
unit volume MADRAID, and primary packaging). Site responsible for batch release in
Contains: SPAIN. the EU and secondary packaging: Lilly, S.A, Avda. de la
Ramucirumab Industria, 30, 28108 Alcobendas, Madrid, Spain.
….10mg/ml
1 vial of 10ml
4. Cyramza Marketing Authorization Holder:
(Concentrate for Eli Lilly Nederland B.V., Grootslag 1-5, NL-3991 RA,
solution for Houten, The Netherlands.
infusion) Manufacturer:
Eli Lilly and Company, Lilly Corporate Center, Indianapolis,
Each unit dose or Idiana (IN) 46285, USA (also responsible for quality control
unit volume and primary packaging). Site responsible for batch release in
Contains: the EU and secondary packaging: Lilly, S.A, Avda. de la
Ramucirumab…… Industria, 30, 28108 Alcobendas, Madrid, Spain.
10mg/ml
1 vial of 50ml
o. Twinrix injection deferred by Registration Board in 269th meeting applied by M/s
GlaxoSmithKline Pakistan Limited, Karachi
M/s GSK Pakistan Limited, Karachi applied for the registration of following human biological.
The case was deferred in 269th meeting of registration Board as per following details:
Name of Importer Brand Name & Type of Form Document Decision of

& Manufacturer Composition Dy No & Date of details 269th meeting
application (CoPP) of RB
Fee submitted
Pack size/
Demanded Price
M/s Twinrix Pediatrics Form-5A Valid Registration
GlaxoSmithKline (Suspension for Injectable) Dy. No. 1709(R&I) legalized Board referred
Pakistan Limited, 30-03-2017 CoPP No. the case to
Karachi Each dose (0.5ml)contains: 29/2017/C Federal EPI
Hepatitis A virus Rs. 100,000/- dated 27- for views on
M/s (inactivated)…..360 ELISA 30-03-2017 02-2017 the need of the
GlaxoSmithKline Units product.
Biologicals,S.A.,ru Hepatitis B surface antigen…. To be provided
e de I’Institute 10 mcg later/ 0.5ml vial,
89,B- Pack of 1, 3 and
1330Rixensart, Shelf Life: 36 months 10’s
Belgium.
National Program Manager EPI response is as under:

“The Federal EPI is not using any combined vaccine of Hepatitis A and Hepatitis B in routine
immunization scheme under one-year children in Pakistan. Therefore, Federal EPI is not in position to
give the opinion for the registration of vaccine. Moreover, according to the current EPI approved plans
the EPI is not planning to introduce such vaccine in routine immunization in coming year”
Decision: Registration Board deferred the case for confirmation by the firm regarding
purpose of registration either for EPI/ Govt. Supplies or for market supplies.
Annex-I
REVISED SAGE RECOMMENDATION ON USE OF DENGUE VACCINE
19 April 2018
WHO published the recommendations of the Strategic Advisory Group of Experts on Immunization
(SAGE) on the use of Dengvaxia® on 27 May 2016, and subsequently a WHO position paper on dengue
vaccine on 29 July 2016.
Following the disclosure of new data on Dengvaxia® by its manufacturer, Sanofi Pasteur, on 29
November 2017 (as described in more detail below), WHO`s Global Advisory Committee on Vaccine
Safety (GACVS) and the WHO Secretariat published interim statements on December 7, 20171, and
December 22, 20172, respectively. WHO initiated a process engaging independent external experts to
review the data in detail, and reconvened the SAGE working group on dengue vaccines. This process
has led to revised recommendations from SAGE on 18 April 2018. An updated WHO position paper on
dengue vaccine will be published in September 2018.
The purpose of this document is to supplement the WHO ”Question and Answer” document from
December December 22, 20172.
Dengue is the most frequent and rapidly spreading mosquito-borne virus. The first dengue vaccine,
CYD-TDV (Dengvaxia®) is currently licensed in twenty countries. The key findings from two large
Phase 3 trials involving over 30,000 participants aged 2 to 16 years included:
 Vaccine efficacy against virologically confirmed dengue, over a 25-month period from the first
dose of a three-dose immunization regimen among 9-16 year olds was 65.6% and in this age-
group, vaccination reduced severe dengue by 93% and dengue hospitalizations by 82%.
 An increased risk of hospitalized dengue was seen in the 2 to 5-year age group in Year 3 of
follow-up.
 At the time of SAGE April 2016 meeting, this increased risk was not observed in those aged 9
years and above.
Because of the higher efficacy of the vaccine against dengue and the absence of an observed increased
risk of hospitalized dengue observed in older children, licensure of the vaccine was sought in 2015
with an indication of 9 years and above. Mathematical modelling suggested that the public health
benefits of vaccination could be maximized if dengue seropositivity in the age group targeted for
vaccination was high.
WHO issued its position on the use of CYD-TDV in July 2016 based on recommendations provided
by SAGE in April 2016, principally, that countries interested in introducing the vaccine consider its
use only in those aged 9 years and above, and in areas with a seroprevalence of ≥70%, and not in areas
below 50%. SAGE noted that the evidence of the absence of a safety issue in seronegative individuals
aged 9 and above was based on the limited data set of 10%-20% of the trial population, and highlighted
the urgent need to better describe the long-term benefit-risk ratio of CYD-TDV in seronegative
individuals.
On 29 November 2017, Sanofi Pasteur announced the results of additional studies to better describe
the benefit-risk in seronegative individuals. This was made possible through the use of a newly
developed NS1-based antibody assay applied to blood samples taken 13 months after vaccination to
retrospectively infer dengue serostatus at time of first vaccination.
The new analyses from the long-term safety follow-up indicated that:
 Overall population level benefit of vaccination remains favorable, but the vaccine performs
differently in seropositive versus seronegative individuals.
 Vaccine efficacy (VE) against virologically confirmed symptomatic dengue was high among
inferred baseline seropositive participants ≥9 years of age: 76% (95%CI: 63.9, to 84.0), but
much lower among baseline seronegative participants: 38.8% (95%CI: –0.9 to 62.9%) in the
first 25 months after the first dose of vaccine.
 There is an increased risk of hospitalized and severe dengue in seronegative individuals starting
about 30 months after the first dose.
 In areas of 70% dengue seroprevalence, over a 5-year follow-up, for every 4 severe cases
prevented in seropositive, there would be one excess severe case in seronegative per 1,000
vaccinees; for every 13 hospitalizations prevented in seropositive vaccinees, there would be 1
excess hospitalization in seronegative vaccinees per 1,000 vaccinees.
In light of the new evidence on the long-term safety issue in seronegative individuals, balanced against
the documented efficacy and safety in seropositive individuals, SAGE carefully considered two
strategies: population seroprevalence criteria versus pre-vaccination screening. SAGE weighed up the
feasibility of population seroprevalence studies and individual pre-vaccination screening,
heterogeneity of seroprevalence between and within countries, potential vaccine coverage rates, public
confidence in national vaccination programmes, perceptions of ethical considerations with regard to
population level benefit versus individual level risk, and communication issues.
SAGE acknowledged that currently both “population seroprevalence criteria” and “pre-vaccination
screening” are programmatically difficult approaches for achieving high population protection from
dengue.
Updated SAGE recommendations on the use of CYD-TDV (Dengvaxia®)
For countries considering vaccination as part of their dengue control program, a “pre-vaccination
screening strategy” would be the preferred option, in which only dengue-seropositive persons are
vaccinated.
Conventional serological testing for dengue virus IgG (e.g. dengue IgG ELISA) could be used to
identify persons who have had previous dengue infections. Sensitivity and specificity of dengue IgG
ELISA should be assessed in a local context, and will depend on the prevalence of other flaviviruses,
and past use of flavivirus vaccines (such as Japanese encephalitis and yellow fever vaccines).
Currently available rapid diagnostic tests - despite their lower sensitivity and specificity to detect past
dengue infection compared with conventional dengue IgG ELISA - could be considered in high
transmission settings until better tests are available. In settings with high dengue transmission (high
numbers of seropositives), a test with lower specificity might be acceptable.
The pre-test probability of an individual being seropositive will be higher in settings with high
transmission. However, a pre-vaccination screening strategy may also be considered in low to moderate
transmission settings. In settings with low transmission (high numbers of seronegatives) a test with
high specificity is needed.
Given that no assay will be 100% specific, some truly seronegative individuals may be vaccinated due
to a false positive test result. Furthermore, although the efficacy against dengue infections in
seropositive individuals is high, it is still not complete. Hence, the limitations of CYD-TDV will need
to be clearly communicated to populations offered vaccination.
There is a continued need to adhere to other disease preventive measures and to seek prompt medical
care in the event of dengue-like symptoms, regardless of whether vaccinated or not. Vaccination should
be considered as part of an integrated dengue prevention and control strategy together with well-
executed and sustained vector control and the best evidence-based clinical care for all patients with
dengue.
Decisions about implementing a “pre-vaccination screening” strategy with the currently available tests
will require careful assessment at the country level, including consideration of the sensitivity and
specificity of available tests and of local priorities, dengue epidemiology, country-specific dengue
hospitalization rates, and affordability of both CYD-TDV and screening tests.
Age
Whether there are age-specific effects, independent of serostatus, is the subject of ongoing research.
Currently, the vaccine should be used within the indicated age range, which is typically 9 to 45 years
of age. The age to target for vaccination depends on the dengue transmission intensity in a given
country, and will be lower in countries with high transmission, and higher in countries with low
transmission. The optimal age group to be targeted is the age at which severe dengue disease incidence
is highest, and this can be ascertained from national and subnational routine hospital surveillance data.
Schedule
In the absence of data on vaccine efficacy and safety with fewer than three doses, CYD-TDV is
recommended as a three dose series given 6 months apart. Should a vaccine dose be delayed for any
reason, it is not necessary to restart the course and the next dose in the series should be administered.
Booster
There are currently no data on the use of booster doses. Additional studies to determine the utility of a
booster dose and its best timing are under way. Accordingly, there is no current recommendation for a
booster dose.
Research priorities
Development of a highly sensitive and specific rapid diagnostic test to determine serostatus, and
assessment of simplified immunization schedules and booster needs should be prioritized.
The full report of the SAGE April 2018 meeting will be published in the WHO Weekly Epidemiological
Record on Friday, 8 June 2018.
Item No.V: Additional Agenda.
Case No. Detail of Item

A. Human Right Case No. 32007-P of 2018
B. Pharmaceutical Evaluation Cell (PEC)
C. Registration-I
D. Registration-II
E. QA/LT Division
F. Division of Biological Evaluation and Research
A. Human Right Case No. 32007-P of 2018 (Application by Dr. Salman Kazmi)
An application was presented before the Hon’ble Chief Justice of Pakistan in Court at Lahore on
18.6.2018. The court has passed following orders:
“Comments/Report be called from Drug Regulatory Authority.”
The Court Associate has directed DRAP vide letter dated 19.06.2018 to comply with the above
direction and submit comments/Reports within 15 days.
The application submitted by Dr. Salman Kazmi, General Secretary, YDA Pakistan in the Hon’ble
Supreme Court of Pakistan requesting to direct DRAP to register following list of Drugs which are not
easily available in Pakistan because of being unregistered in Pakistan and are being sold in black. The
list contains 41 drugs (molecules/brands). Out of these, 25 drugs (formulations/ alternate brands) are
registered with DRAP (including 2 repeated drugs i.e. Penicillamine and phenobarbitone). While, 16
drugs (formulations) are not registered in Pakistan (midodrine repeated twice). The status of registered
drugs is given in the 1st table while current status of pending / under process applications as per
available record is presented in 2nd table as follows:
Table 1: Registered Drugs and Alternatives
ALTERNATIVE BRANDS
S.No
S.No Formulation Reg.No Name of Drug(s) & Manufacturer/Importer
in list
Composition
Imported by M/s
020713 Adenosine i.v injection Highnoon Laboratories,
Adenosine 6 mg,
Lahore
Injection
1 4
Imported by M/s
Alternatives (02) 020715 Adenosine i.v injection
Highnoon Laboratories,
Lahore
Morphine 15 mg/ Scotmann
Morfscot Injections
ml, Injection Pharmaceuticals, Plot
2 5 028300 10mg
NoE-5, Sector I-
Each 1 ml contains:
Alternatives (05) 10/3Islamabad.
ALTERNATIVE BRANDS
S.No
in list
Composition
Morphine
Sulphate….10mg
Morfscot Injections
Scotmann
20mg
Pharmaceuticals, Plot
028301 Each 1 ml contains:
NoE-5, Sector I-
Morphine
10/3Islamabad.
Sulphate…..20 mg
Morfscot Injections
Scotmann
30mg
Pharmaceuticals, Plot
028302 Each 1 ml contains:
NoE-5, Sector I-
Morphine
10/3Islamabad.
Sulphate…30 mg
Qonza Injection Wilshire Laboratories
Each ml contains:- (Pvt) Ltd; 124/1 Industrial
080060
Morphine Sulphate ... Estate, Kot Lakhpat,
15mg Lahore.
Morphine Injection PDH Laboratories, 9.5 km
003754 Morphine Sheikhupura Road,
Sulphate….15 mg Lahore
Magnus (Duralgin)MR
Osmopharm S.A.,
10 mg Capsules
Switzerland,
021084 Each capsule contains:
Imported by M/s AGP
Morphine Sulphate…
Karachi
10 mg
Qonza 30mg Tablets Wilshire Laboratories
Each tablet contains:- (Pvt) Ltd; 124/1 Industrial
Morphine sulphate
065704 Morphine sulphate Estate, Kot Lakhpat,
10mg,30 mg,
………..30mg Lahore.
Capsule/Tablet
3 6 (B.P Specs)
Qonza 10mg Tablet Wilshire Laboratories
Alternatives (04)
Each tablet contains:- (Pvt) Ltd; 124/1 Industrial
071221 Morphine Estate, Kot Lakhpat,
Sulphate….10mg Lahore.
(B.P Specs)
Magnus (Duralgin) Osmopharm S.A.,
MR 30 mg Capsules Switzerland
021083
Morphine Sulphate… AGP Karachi
30 mg
Genetech DPT
Booster for
Vaccine
Diphtheria after 7 M/s Gene-Tech
059270 Each ml contains:
years Tdap Laboratories, Karachi
4 7 DIPHTHERIA
(vaccine)
ANTIGEN
M/s GlaxoSmithKline,
Alternatives (02) 087954 Boostrix Vaccine
West Wharf, Karachi
Immunoglobulin for Imported by M/s
000974 Rabies Antiserum
Rabies IVIG against Hakimsons, Karachi
Rabies M/s Popular International,
5 8 007972 Hyperrab
Karachi
Imported by M/s
005900 Rabuman
Alternatives (05) Hakimsons, Karachi
ALTERNATIVE BRANDS
S.No
in list
Composition
Imported by M/s Hospital
053817 Anti-Rabies Serum
Services &Sales, Karachi
Imported by M/s Sanofi-
033180 Favirab
Aventis Pakistan, Karachi
Colomycin Injection
Colistin 50 mg, Imported by M/s AJ&
6 9 008624 Contains:
Injection Co., Karachi
Colomycin… 50 mg
Mirapront Capsule
Phentermine 30mg,
7 10 002141 Each capsule contains: M/s Schazoo, Lahore
Tablet
Phentermine … 15 mg
JANSSEN
Durogesic TTS PHARMACEUTICA
Patches 25 mcg/hr N.V BELGIUM,
027370
Contains: Imported by M/s
Fentanyl… 25 mcg/hr JOHNSON & JOHNSON
LTD KARACHI
Fentanyl Sandoz 25
M/s Novartis Pharma
Fentanyl patches 081194 mcg/h transdermal
(Pakistan) Ltd., Karachi
8 16 Patches
Fentanyl Sandoz 50 M/s Novartis Pharma
Alternatives (02) 081195 mcg/h transdermal (Pakistan) Ltd., Karachi
Patches
Fentavera 25 mcg/h M/s Highnoon
080528
Transdermal Patches Laboratories, Karachi
Fentavera 50 mcg/h M/s Highnoon
080529
Transdermal Patches Laboratories, Karachi
M/s Bayer, Karachi

Nimotop, Infusion Nimotop Infusion
17 solution
9 010454
Contains:
Alternatives (01) Nimodipine 0.01GM,
047551 NILISU
(NIMODIPINE)
INJECTION 2MG.
Imported by M/s
EACH 10ML
MORGAN
CONTAINS:-
CHEMICALS,
NIMODIPINE …
KARACHI
2MG.
(ANTI-
HYPERTENSIVE).
M/s Wilson's
Vistamin 250 mg
008202 Pharmaceuticals,
D Penicillamine, Tablet
Islamabad
Tablet Penicillamine..250 mg
10 19
Cillamin 250mg Genome Pharmaceuticals,
Alternatives (04) Tablets Industrial Estate Hattar
083802
Each film coated
contains:
ALTERNATIVE BRANDS
S.No
in list
Composition
Penicillamine…250
mg
Carlton Tablet 250mg M/s PolyFine
Each film coated ChemPharma, Peshawar
085917 contains:
Penicillamine……250
mg
Penicillamine Tablet M/s Medisure
83907 Each tablet contains: Laboratories, Karachi
D-Penicillamine… 250
mg
Anfogen 50 Injection Imported by M/s
Amphotericin B, Contains: Ferozsons Laboratories,
11 20 045800
Injection Amphotericin B… 50 Nowshera
mg
M/s Hilton Pharma,

044068 Nukik 2mg Gum
Karachi
Nicotine gums &
12 21
patches
M/s Hilton Pharma,
44069 Nukik 4mg Gum
Karachi
Welbutrin XL Tablets
Each tablet contains: M/s GlaxoSmithKline,
045794
Bupropion … 300 mg Karachi
045427 Budep 150mg Tablets Pharmatech, Karachi
WELLBUTRIN XL GlaxoSmithKline,
045794
TABLETS 300MG. Karachi
varenecline,
13 22
bupropion
047762 Bupron Tablets CCL, Lahore
048505 Smokik Tablets Hilton Pharma, Karachi
Wellben SR 75mg
050778 Bosch, Karachi
Tablet
ALTERNATIVE BRANDS
S.No
in list
Composition
Wilshire Laboratories,
065708 Qoby SR 75mg Tablets
Lahore
Anzee SR 150mg
067009 Amarant, Karachi
Tablet
Deprion SR 300mg
067386 Amarant, Karachi
Tablet
Genome Pharmaceuticals,
068381 Butrin 75mg Tablets
Industrial Estate Hattar
Butrin XL150mg Genome Pharmaceuticals,

068382
Tablets Industrial Estate Hattar
Butrin XL 300mg Genome Pharmaceuticals,

068383
Tablets Industrial Estate Hattar
076184 Ropion 100mg Tablet Searle, Karachi
Ropion SR 150mg
076185 Searle, Karachi
Tablet
14 23 Nitrofurontoin 100 Furadantin Tablets

mg , Tablet Each tablet contains: M/s GlaxoSmithKline,
000068
Nitrofurantoin…. 100 Karachi
mg
Anatrin TabletEach
tablet contains M/s Jupiter PharmaPlot #
081913 Nitrofurantoin 25, St# S6 RCCI, Rawat
…….100 mg (BP Islamabad
Specification)
Uristron 100 mg Tablet
Nitrofurantoin…. 100 Willson's
006881 mg Pharmaceuticals,
Islamabad
Furalin 100mg Tablet

083071
Nitrofurantoin… 100 Ciba Pharmaceuticals,
mg Karachi.
ALTERNATIVE BRANDS
S.No
in list
Composition
URANTOIN PLUS
013566 100 CAP
Nitrofurantoin…. 100 CCL Pharmaceuticals,
mg Lahore
Furadantin Tablets
000068 Each tablet contains:
Nitrofurantoin…. 100
mg GSK, Karachi
Nitrofurantoin Tablets Glitz Pharma, 265

038568
Nitrofurantoin 100 mg Industrial Estate, Kahuta
Triangle, Islamabad
Furadin Tablets
Each tablet contains: FEROZSONS
011590
Nitrofurantoin…. 100 LABORATORIES
mg LIMITED, NOWSHERA
Biflocin 500 mg
Capsules
Flucloxacillin 500 Each capsule contains:
15 24 009971 M/s PDH, Lahore
mg, Tablet Flucloxacillin … 500
mg
VACOCIN (ORAL) Imported by M/s AGP,

16 25 Oral Vancomycin 008304
INJ Karachi
Deponit-10 Patch
Deponit or Each patch contains:
M/s Atco Laboratories,
17 28 Nitriderm patch 5 008862 Glyceryl Trinitrate…
Karachi
mg and 10 mg 10 mg
Adrenaline Injection
Each ampoule
Adrenaline prefilled Imported by M/s Shaheen
18 30 001270 contains:
injection Agency, Karachi
ADERNALINE 0.1%,
19 31 Phenobarbitone Phenobarbitone
injection Injection Contains:
011697
PHENOBARBITONE M/s Pioneer, Karachi
200MG/1ML
011697
PHENOBARBITONE
200MG/1ML INJ Pioneer, Karachi
013198
PHENOBARBITONE Orient Laboratories,
SODIUM 200MG/ML Lahore
ALTERNATIVE BRANDS
S.No
in list
Composition
PHENO-B
INJECTION S,J & G FazalEllahie,
021435 Karachi
PHENOBARBITONE
INJECTION
022186 Amros Pharma, Karachi
Phenobarbitone
028893
Injection
Sulson Pharma, Lahore
048591
Phenobarb Injections
Atco Laboratories,
Karachi
064485 Phenomed Injection

Medicraft, Peshawar
065757 Nubarbi Injection

Neutro Pharma, Lahore
P-Barbi Injection
065969
200mg
Fynk Pharma, Lahore
079731 P-Bar Injection

Sayydon Pharmaceutical
Industries, Hattar
Anexate Injection
flumazenil ,
20 32 019493 Each ml contains: M/s Martin Dow, Karachi
Injection
Flumazenil …
21 34 Protamine Sulphate,
Injection Protamine Sulfate
006121 M/s LC&PW Lahore
Injection 500MG
000663 PROTAMINE
SULPHATE
INJECTION Evans, Karachi
008853
PROTAMINE ZAM ZAM CORP
SULPHATE KARACHI
ALTERNATIVE BRANDS
S.No
in list
Composition
PROSULF STERILE
017424
INJECTION
Bio Pharma, Multan
22 37 Colchicine, Tablet 003963 Colchine 0.5 mg Tablet M/s LC&PW Lahore
Kreon 10000 capsules

Pancreatin ….150mg
in enteric coated
granules
minimicrosheres, eq to
M/s Abbott Laboratories,
23 38 Creon Capsule 047677 8000 ph.eur. Units,
Karachi
Amylase 600 ph.eur.
Units total Protease
…10000 ph.eur. Units
lipase.
Table 2: Status of pending applications for registration

# Name of Drug Applications pending for registration
# Applied Formulation Applicant details Application date /
remarks
1. Injection Isoptin 5 i. Calan 5mg/2ml Injection M/s The Searle 06-12-2017
mg (verapamil) Company Limited,
used in cardiac Each 5ml Contains: Karachi.
arrhythmias Verapamil
Hydrochloride…5mg
2. Inj. Adenosine 6 mg i. Caden 6mg/2ml Solution Importer: M/s 16-05-2018
used in cardiac for Injection Himmel
arrhytmias Pharmaceuticals
Each ml Solution for Pvt Ltd. 793-D
Injection Contains: Block C, Faisal
Adenosine…3mg Town, Lahore,
Pakistan
Manufacturer:
M/s
Valdepharms.A.
ParcIndustrield'
Incarville,
ParcdelaFringale-
CS10606, 27106
ValdeReuilCedex,
France
3. Inj. Morphine 15 mg/ i. Morphate 15mg/ml M/s Genix Pharma, Deferred in 281st
ml used in cancer and Injection Karachi meeting of
Myocardial Each ml contains: Registration Board
Infarction Patients Morphine sulphate held on (11th-13th
pentahydrate eq to April, 2018) for
“evidence of approval
Morphine of required
sulphate…..15mg manufacturing facility
for applied
formulation”
Letter issued to lic
division for
confirmation.
4. Cap/ Tab Morphine i. Morphine MR capsule M/s Pacific Approved in 281st
sulphate 10mg, 30 30mg Pharmaceuticals, meeting of
mg used as Pain Each extended release Lahore Registration Board
Killer capsule contains: held on (11th-13th
Morphine April, 2018)
sulphate…..30mg
ii. Morphate 30mg Prolong M/s Genix Pharma, Deferred in 281st
release tablet Karachi meeting of
Each prolong release film Registration Board
coated tablet contains: held on (11th-13th
Morphine sulphate April, 2018) for
pentahydrate eq to “evidence of applied
Morphine formulation/drug
sulphate…..30mg already approved by
DRAP (generic / me-
too status) alongwith
registration number,
brand name and name
of firm”
iii. MORFIN SR-30 Tablets Brookes Pharma 9-6-2015
Each sustained release film (Pvt) Ltd., 58 & 59, Firm has been
coated tablet contains: Sector 15, Korangi communicated to
Morphine sulfate…..30mg Industrial Area, provide evidence of
Karachi me-too status or
stability study data on
following dates but no
reply has been
received.
Initial Letter
3-4-2018
Reminder
17-5-2018
iv. Morfin SR 10 Tablets M/s Brookes Form 5-D
Each film coated tablet Pharma (Pvt) Ltd., 09.06.2015
contains:- Karachi
Morphine Sulfate B.P.
10.00mg
v. Morphate 10mg Prolong M/s Genix Pharma, Deferred in 281st
release tablet Karachi meeting of
Each Prolong Release film Registration Board
coated tablet contains: “for evidence of
Morphine Sulfate applied
Pentahydrate eq to formulation/drug
Morphine already approved by
sulphate…….10mg DRAP (generic / me-
too status) alongwith
registration number,
brand name and name
of firm”
rd th
5. Tab Riluzole i. Rile 50mg Tablet A’RAF (Pvt) Ltd, Form 5
Each tablet contains:- 23-Km, Raiwind 10-12-2014
Riluzole….50mg Road, Lahore (New molecule, thus
required application
on Form 5-D)
ii. Rile 50mg Tablets M/s A’raf Pvt Ltd., Form 5-D
Each film coated tablet Lahore 26.10.2015
contains:-
Riluzole 50mg
6. Injection i. Phosome 50mg Powder for M/s AJ Mirza Pvt Deferred in 259th
Amphotericin B used Injection Ltd, 7-Ground meeting for
as Anti Fungal Each vial contains:- Floor, Shafi Court, “confirmation of
Liposomal Amphotericin Merewether Road, importation status
B……………….50mg Civil Lines, from India as per
Karachi. Import Policy Order”
Manufactured by
M/s Cipla Ltd, Plot Deferred in 263rd
M-61, M-62 & M- meeting for
63, Verna Industrial “Confirmation of
Estate, Verna Goa. importation status
from India (as per
import Policy Order)
by Ministry of
Commerce”
Ministry of
Commerce was
requested through
letter to confirm
however they have
asked for HS codes of
the product.
ii. Ambilip 50mg Injection M/s. Revive Health Deferred in 264th
Each vial contains:- Care, meeting for
Liposomal Amphotericin B Office 503, 5th “Confirmation
USP………50mg Floor, 6 Main whether applied
Gulberg, Jail Road, formulation can be
Lahore. imported from India
M/s. United as per Import Policy
Biotech (P) Ltd., Order.”
Village Bagbania,
Baddi-Nalagarh
Road, District-
Solan (H.P)
174101, India.
iii. Amphotin Lip-50 Injection M/s. Revive Health Deferred in 264th
Each vial contains:- Care, Office 503, meeting for
Amphotericin B Lipid 5th Floor, 6 Main “confirmation
Complex…50mg Gulberg, Jail Road, whether applied
Lahore. M/s. formulation can be
United Biotech (P) imported from India
Ltd., Village as per Import Policy
Bagbania, Baddi- Order”
Nalagarh Road,
District-Solan
(Himachal Pradesh)
174101, India.
iv. Amphotin 50mg Injection M/s. Revive Health Deferred in 264th
(Lyophilized) Each vial Care, Office meeting for
contains:- Amphotericin B
No.503, 5th Floor, “confirmation
(Lyophilized)……….50m 6 Main Gulberg, whether applied
g Jail Road, Lahore. formulation can be
M/s. United imported from India
Biotech (P) as per Import Policy
Limited, Bagbani, Order”
Baddi, Nalagarh
Road, District,
Solan, India.
7. Varenecline, i. Nicline 1mg Tablets M/s Valor Deferred in 281st
bupropion Each film coated tablet Pharmaceuticals meeting for
contains: (Pvt.) Ltd.,124/A “submission of fee for
Varenicline…………..1mg Kahuta revision of master
Road, Industrial formulation”
Triangle Zone,
Islamabad.
ii. Glitpro 150mg Tablets M/s Glitz Pharma, Deferred in 263rd
Each tablet contains:- Plot No. 265, meeting for “
Bupropion HCL ………. Industrial Triangle confirmation of
150mg Kahota Road formulation whether
Islamabad modified release or
otherwise”
iii. Owenta 75mg SR Tablet M/s Noa Hemis Deferred in 276th
Each sustained release Plot #154, Sector meeting for "
tablet contains: 23, Korangi submission of fee of
Bupropion hydrochloride industrial area Rs. 20,000/- for
….75 mg Karachi. change of
formulation”
iv. Wrdrop 150mg Tablets M/s. Welwrd 16-7-2014

Bupropion ……….. 150 (Pvt)Ltd;Hattar (Duplicate application
mg with no evidence of
fee and R&I)
v. Zyban 150mg Tablet M/s Bio Mark 16-11-2017
Each Extended Release Pharmaceuticals,
Tablet Contains: Plot No. 527,
Bupropion (as Sundar Industrial
Hydrochloride)…150mg Estate,Lahore
vi. Zyban 300mg Tablet M/s Bio Mark 16-11-2017
Each Extended Release Pharmaceuticals,
Tablet Contains: Plot No. 527,
Bupropion (as Sundar Industrial
Hydrochloride)…300mg Estate,Lahore
vii. B-Pion 75mg Tablet M/s Theramed 27-12-2017
Each Film Coated Tablet Pharmaceutical Pvt
Contains: Ltd.
Bupropion 45-km, Multan
Hydrochloride…75mg Road, Lahore
viii. B-Pion XR 300mg Tablet M/s Theramed 27-12-2017
Each Extended Release Pharmaceutical Pvt
Tablet Contains: Ltd.
ix. B-Pion XR 150mg Tablet M/s Theramed 27-12-2017
Each Extended Release Pharmaceutical Pvt
Tablet Contains: Ltd.
x. Novoprop 300mg Tablet M/s Wenovo 28-12-2017
Each Extended Release Pharmaceuticals.
Tablet Contains: Plot # 31& 32
Bupropion…300mg Punjab Small
Industrial Estate
Taxila Pakistan
xi. Novoprop 150mg Tablet M/s Wenovo 28-12-2017
Each Extended Release Pharmaceuticals.
Tablet Contains: Plot # 31& 32
Bupropion…150mg Punjab Small
Industrial Estate
Taxila Pakistan
xii. Bupion SR 75mg Tablet M/s Medizan 06-10-2016
Each sustained release Laboratories,
tablet contains: Islamabad
Bupropion
hydrochloride…….75mg
8. Tab. Nitrofurontoin i. Noin 100mg tablets M/s Deferred in 273rd
Saibins
100 mg Each film coated tablet pharmaceuticals, meeting for
contains: Nitrofurantoin Plot “Clarification
No.316
…… 100mg Industrial triangle,
regarding whether the
Kahuta road,
applied product is film
Islamabad coated or controlled
release tablets
Composition of
coating solution in
case of coated tablets.
Evidence of
approval of applied
formulation as film
coated tablets in
reference regulatory
authorities/agencies”
ii. Nitron 100mg Tablet M/s. Allmed (Pvt) 11‐ 6‐ 2012
Each tablet contains:‐ Ltd Lahore Rs.8000/‐
Nitrofuranton…..100mg 11‐ 10‐ 2012
Rs.12000/‐
9. Metolazone 5 mg i. Metazone 2.5mg Tablets M/s Neutro Pharma Form 5-D
ii. Metazone 5mg Tablets (Pvt) Ltd. 9.5 km, 08-03-2018
iii. Metazone 10mg Tablets Sheikhupura
Road,Lahore
iv. Metoxolyn Tablets 10mg M/s Getz Pharma Form 5-D
Each film coated tablet Pvt. Ltd., Karachi 22.04.2013
contains:-
Metolazone 10mg
v. Metoxolyn Tablets 2.5mg M/s Getz Pharma Form 5-D
Each tablet contains:- Pvt. Ltd., Karachi 22.04.2013
Metolazone USP 2.5mg
vi. Metoxolyn Tablets 5mg M/s Getz Pharma Form 5-D
Pvt. Ltd., Karachi 22.04.2013
Each film coated tablet
contains:-
Metolazone 5mg
vii. Mila 5mg Tablets M/s Pharmatec Form 5-D
Each tablet contains:- Pakistan (Pvt) Ltd., 07.07.2014
Metolazone USP 5mg Karachi
viii. Mila 10mg Tablets M/s Pharmatec Form 5-D
Each tablet contains:- Pakistan (Pvt) Ltd., 07.07.2014
Metolazone USP 10mg Karachi
ix. Metol Tablet 5mg M/s Biogen Form 5-D
Each tablet contains: Pharma, 17-4-2015
Metolazone…..5mg Rawalpindi
10. Inj Phenobarbitone i. Phenobarbital Injection M/s Venus Pharma. 11-05-2018
11. Injection Each ml Contains: 23 km, Multan
Phenobarbitone used Phenobarbital Road, Lahore
in status epilepticus Sodium…200mg
(Repeat)
12. Inj flumazenil i. Flumaze 100mcg/ml M/s Venus Pharma. 11-05-2018
Injection 23 km, Multan
Each ml glass ampoule Road, Lahore
Contains:
Flumazenil…100mcg
13. Tablet Perfenidone i. Pirfen 200mg Tablets M/s Scilife Pharma 07-05-2018
used in Interstitial Each Film Coated Tablet Pvt Ltd.
Lung Disease Contains: Plot # FD-57/58-
Pirfenidone…200mg A2, Korangi Creek
Industrial Park,
Karachi
ii. Fenid 267mg Tablet M/s Macter Form 5-D
Each Tablet Contains: International 17-01-2018
Pirfenidone…267mg Limited. F-216,
S.I.T.E. Karachi,
Pakistan
iii. Fenid 801mg Tablet M/s Macter 06-03-2018
Each Tablet Contains: International
Pirfenidone…801mg Limited.F-216,
S.I.T.E. Karachi,
Pakistan
iv. Xader 267mg Capsules M/s Wilshire 26-02-2018
Each Capsule Contains: Laboratories Pvt
Pirfenidone…267mg Ltd. 124/1, Quaid-
e-Azam Industrial
Estate, Kot
Lakhpat, Lahore
v. Pirfen 267mg Tablet M/s Getz Pharma 25-09-2017
Each film coated tablet Karachi.
contains:
Pirfenidone……267mg
vi. Pirfen 801mg Tablet M/s Getz Pharma 25-09-2017
Each film coated tablet Karachi.
contains:
Pirfenidone……801mg
vii. Fenid Capsules 267mg M/s Macter File has been
Each capsule contains:- International, evaluated and panel
Pirfenidone 267mg Karachi has been constituted
for onsite
investigation of
stability data.
viii. IPF 200mg Tablets M/s Genome Form 5-D
Each film coated tablet Pharmaceuticals 09.03.2015
contains:- Pvt Ltd., Hattar
Pirfenidone 200mg
ix. Perfix 267mg Tablet M/s Helix Pharma 21.07.2017
Eachfilm coated tablet (Pvt), Ltd., Karachi
contains:-
Pirfenidone 267mg
14. EMLA cream. Used i. Emlex Cream Seatle(Pvt) Ltd., Form 5-D
to anesthetize skin Each gram contains:- Lahore 16.10.2015
for minor Lidocaine 25mg
procedures (IV Prilocaine 25mg
cannulation) ii. Anes Cream 10gm M/s. Medi Mark Form 5-A
Each gram contains:- Pharmaceuticals, 24-06-2016
Lidocaine 2.5% w/w Lidocaine…………….25 Liaqut Chowk,
(25 mg/g) mg Sahiwal. /
Prilocaine 2.5% w/w Prilocaine……………25m M/s. Tai Guk
(25 mg/g) g Pharm. Co. Ltd.
821, Geumbaek-ro,
Chochon-myeon,
Buyeo-gun,
Chungcheongnam-
do, Republic of
Korea.
15. Injection Alteplase Biological drug,
20 mg and 50 mg per Details of 2 applications mentioned in agenda.
vial used in
Myocardial
Infarction and
Ischemic stroke
16. Booster for Biological product,
Diphtheria after 7 No application pending for evaluation at present as per available record
years Tdap
(vaccine)
17. Immunoglobulin for Biological product,
Rabies IVIG against No application pending for evaluation at present as per available record
Rabies
18. Tab Hydrocortisone No application pending for evaluation at present as per available record
25 mg and 10 mg
used in Addison
Disease
19. Inj. Colistin 50 mg No application (Human) pending for evaluation at present as per available record
broad spectrum anti
biotoc
20. Tab Phentermine No application pending for evaluation at present as per available record
30mg used in obesity
21. Activated 633ntibiot No application pending for evaluation at present as per available record
used as antidote in
multiple poisonin
22. Tab Flecainide used No application pending for evaluation at present as per available record
as anti-arrhythmic
23. Inj. Glucagon used in No application pending for evaluation at present as per available record
Beta Blocker
Poisoning and
634ntibiotic634ia
24. Intra lipid 20% No application pending for evaluation at present as per available record
25. Fentanyl patches No application pending for evaluation at present as per available record
26. Nimotop No application pending for evaluation at present as per available record
(Nimodipine) IV
used in
Haemorraghic CVA
27. Nicotine gums & No application pending for evaluation at present as per available record
patches
28. Tab.Flucloxacillin No application pending for evaluation at present as per available record
500 mg
29. Oral vancomycin No application pending for evaluation at present as per available record
used as 634ntibiotic
30. Injection No application pending for evaluation at present as per available record
levobupivicaine
31. Deponit or No application pending for evaluation at present as per available record
Nitriderm patch 5
mg and 10 mg
32. Adrenaline prefilled No application pending for evaluation at present as per available record
injection
33. Injection Protamine No application pending for evaluation at present as per available record
Sulphate used as
antidote of Heparin
34. Tablet Colchicine No application pending for evaluation at present as per available record
for Gout
35. Creon Capsule for No application pending for evaluation at present as per available record
cystic Fibrosis
Patients
36. Prostaglandins E1 No application pending for evaluation at present as per available record
37. Dantrolene used in No application pending for evaluation at present as per available record
Malignant
hHyperthermia.
38. Midodrine 2.5mg No application pending for evaluation at present as per available record
39. Tablet midodrine No application pending for evaluation at present as per available record
(Repetition)
40. Tab. Vistamine for No application pending for evaluation at present as per available record (Tablet
Wilson disease Vistamin of Wilson Pharma is already registered in local manufacturing)
41. Tab D No application pending for evaluation at present as per available record
Penicillamine
(Repetition)
Status of above applications was presented before the Board for its directions. Accordingly as per the
direction of Registration Board, following applications were evaluated and presented before the
Board as per current status of each application.
1. Injection Isoptin 5 mg (verapamil) used in cardiac arrhythmias
1. Name and address of manufacturer / M/s The Searle Company limited,
Applicant F-319 S.I.T.E. Karachi.
Brand Name +Dosage Form + CALAN 5mg/2ml Injection
Strength
Diary No. Date of R& I & fee Diary No. 23311, 06-12-2017 , Rs: 20,000/-
Composition Each 2ml ampoule contains: -
Verapamil hydrochloride …5mg
Pharmacological Group Calcium Channel Blocker- Anti Arrythmic agent
Type of Form Form-5
Pack size & Demanded Price 1’s, 5’s & 10’s /As per SRO
Approval status of product in Securon IV solution for intravenous injection 5mg/2ml by
Reference Regulatory Authorities. M/s Mylan Products Ltd. (MHRA Approved)
Me-too status Vepamil Injection Verapamil HCl 5mg (2ml ampoule) by
M/s Searle IV Solutions (Pvt.) Ltd, Lahore (Reg#080663)
GMP status Last GMP inspection report dated 13-2-2018: Followup, as
per the data provided by QALT division.
Decision: Approved.
2. Inj. Adenosine 6 mg used in cardiac arrhythmias
1. Name and address of Applicant M/s Himmel Pharmaceuticals Pvt Ltd.

793-D, Block “C” Faisal Town Lahore, Pakistan
Detail of Drug Sale License Adress: M/s Himmel Pharmaceuticals, 793D, Block C, Faisal
Town, District Lahore.
Validity: 6-2-2020
Status: License to sell drugs as a Distributor.
Name and address of manufacturer M/s Valdepharms.A ParcIndustrield’ Incarville,
ParcdelaFringale-CS10606, 27106 ValdeReuilCedex, France
Name and address of marketing M/s Pharma Bavaria Internacional (PBI) Portugal,Unipessol
authorization holder Lda. Rua do Monte Leite, 498, 1’ Dto. 2765-496 Estoril
Portugal.
Name of exporting country Portugal
Brand Name +Dosage Form + Caden 6mg/2ml solution for Injection IV
Strength
Composition Each2 ml vial contains:
Adenosine……6mg
Pharmacological Group Cadiovascular apparatus. Antiarrhythmics
ATC Code: CO1EB10
Shelf life 3Years
Pack size (2ml)6’s, Type I clear glass Vial
International availability MHRA Approved
Me-too status ADENOSINE I.V INJECTIONEACH ML CONTAINS
ADENOSINE 3MG Imported by HIGHNOON LABS
LAHORE Reg # 020713
Detail of certificates attached ● Original legalized CoPP issued on 3-11-2015 by
Autoridade Nacional do Medicamento e Produtos de
Saude I.P. (INFARMED) confirms free sale of the
manufacturer.
● Original Legalized GMP certificate(Issued by French
national Agency for Medicines and Health Products
Safety) of the manufacturer is submitted which is issued
on 29-8-2016 and is valid up to October 20th, 2017.
Certificate #HPF/FR/193/2016.
● Original Sole agency agreement by Pharma Bavaria
International GmbH, issued on 18-04-2018 is submitted.
 Firm has submitted 6 months accelerated stability study(40+-2 ‘C, 75RH+-5%) data and 36
months real-time (25+-2 ‘C, 60RH+-5%) stability study data , 36 months Intermediate stability
(30’C+-2’C, 65RH+-5%RH) study data of 3 batches.
Initiation dates:
Batch #A6A03 (October-2012)
Firm has deposited fee challan of Rs.50,000/-
Decision: Deferred for submission of:
 Differential fee of Rs. 50,000/- since applied formulation has already been registered by
DRAP.
 Original, legalized GMP certificate since the submitted GMP certificate is expired.
3. Inj. Morphine 15 mg/ ml used in cancer and Myocardial Infarction Patients
1. Name and address of manufacturer / M/s Genix Pharma, Karachi

Applicant
Brand Name +Dosage Form + Strength Morphate 15mg/ml Injection
Morphine sulphate pentahydrate eq to Morphine
sulphate…..15mg
Pharmacological Group Opiod
Type of Form Form-5
Approval status of product in Reference Morphine Sulfate 15mg/ml Solution for Injection,
Regulatory Authorities. MHRA Approved
Me-too status Qonza Injection Reg # 080060
GMP status Last inspection report 8-8-2017 firm was considered to
be operating at a satisfactory level of compliance with
GMP
Remarks of the Evaluator. Injectable (Psychotropic) section could not be confirmed.
Previous decision: Registration Board in its 281st meeting deferred the case
for following reason:
Evidence of approval of required manufacturing facility
for applied formulation.
Evaluation by PEC Applicant does not have psychotropic sections as per
available record with Licensing division.
Decision: Registration Board rejected as firm does not have approved manufacturing facility.
4. Cap/ Tab Morphine sulphate 10mg, 30 mg used as Pain Killer
1. Name and address of manufacturer / Brookes Pharma (Pvt) Ltd., 58 & 59, Sector 15, Korangi
Brand Name +Dosage Form + Strength MORFIN SR-30 Tablets
PKR 50,000/-: 9-6-2015
Composition Each sustained release film coated tablet contains:
Morphine sulfate…..30mg
Pharmacological Group (Narcotic analgesic)
Type of Form Form 5
Finished Product Specification BP Specs
Approval status of product in Reference Morphgesic SR 30mg Tablets by Amdipharm UK
Me-too status MST Continus Tablet 30mg by ALI GOHAR & CO
GMP status GMP certificate issued on the basis of inspection report conducted
on 07-05-2018
Remarks of the Evaluator. Firm has initially applied on Form 5-D, and later on they submitted
Form 5 since this product has already been registered.
2. Name and address of manufacturer / Brookes Pharma (Pvt) Ltd., 58 & 59, Sector 15, Korangi
Brand Name +Dosage Form + Strength MORFIN SR-10 Tablets
Diary No. Date of R& I & fee Initial R&I date: 09-06-2015 (Photocopy)
PKR 50,000/-: 9-6-2015 (Photocopy challan)
Duplicate dossier dated 28-06-2018
Morphine sulfate…..10mg
Pharmacological Group (Narcotic analgesic)
Type of Form Form 5
Finished Product Specification BP Specs
Approval status of product in Reference Morphgesic SR 10mg Tablets by Amdipharm UK
Me-too status MST Continus Tablet 10mg by ALI GOHAR & CO
GMP status GMP certificate issued on the basis of inspection report conducted
on 07-05-2018
Remarks of the Evaluator. Firm has initially applied on Form 5-D, and later on they submitted
Form 5 since this product has already been registered.
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
Pharmacological Group Opoid
Type of Form Form-5
Approval status of product in Reference Filnarine SR 10 mg prolonged release film-coated tablets,
GMP status Last inspection report 8-8-2017 firm was considered to be
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.
Previous Decision: Decision of 281st : Deferred 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: Firm has submitted a registration letter photocopy :
MST Continuous tablets 10mg (Reg # 017492)
Morphine sulfate….10mg
(Manufactured by Bard Pharmaceuticals, UK, imported by
Ali Gohar & Co. Pvt Ltd), Karachi
 Evidence of approved manufacturing facility from licensing division.
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
Pharmacological Group Opoid
Type of Form Form-5
Approval status of product in Reference Filnarine SR 30 mg prolonged release film-coated tablets,
GMP status Last inspection report 8-8-2017 firm was considered to be
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
Previous Decision: Decision of 281st : Deferred 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: Firm has submitted a registration letter photocopy :
MST Continuous tablets 30mg (Reg # 017493)
Morphine sulfate….30mg
(Manufactured by Bard Pharmaceuticals, UK, imported by
Ali Gohar & Co. Pvt Ltd), Karachi
 Evidence of approved manufacturing facility from licensing division.
5. Tab Riluzole
1. Name and address of manufacturer / M/s A’RAF (Pvt) Ltd,
Applicant 23-Km, Raiwind Road, Lahore
Brand Name +Dosage Form + Strength Rile Tablets 50mg
Diary No. Date of R& I & fee Diary No:1246, 26/10/2015, Rs: 50,000/- (Challan#
0500153, Dated: 22/10/2015)
Riluzole …50mg
Pharmacological Group Other nervous system drugs
Pack size & Demanded Price 3x10’s / As per SRO
Approval status of product in Reference Riluzole 50 mg film-coated tablets by M/s Aptil Pharma
Me-too status N/A
GMP status Not confirm.
Remarks of the Evaluator.  Firm has not submitted real time and accelerated
stability study data for 3 batches as per Zone IV-A.
 GMP status of the firm not confirm.
Decision: Deferred for submission of:
 Stability study data along with associated documents as per the requirements of 278th
 Latest GMP inspection report within last 1 year.
6. Injection Amphotericin B used as Anti-Fungal

Sr.# Name and Brand Name Type of Remarks on Previous RB Decision
address of (Proprietary Form the Remarks of
manufacturer / name + Dosage Initial date, formulation the
Applicant Form + diary (if any) Evaluator.
Strength) Fee including including
Composition differential International
Pharmacologica fee status in
l Group Demanded stringent
Finished Price / Pack drug
product size regulatory
Specification agencies /
authorities
Me-too status
GMP status
as depicted in
latest
inspection
report (with
date) by the
Evaluator
1. M/s. Revive Ambilip 50mg Form 5A MHRA. COPP valid 260th Meeting
Health Care, Injection Dy No.29 Ambisome upto 10-05- Registration
Office 503, 5th Each vial dated 04-07- 50mg Powder 2017. Board held on
Floor, 6 Main contains:- 2014 for Infusion by GMP 28-29th June,
Gulberg, Jail Liposomal Rs.100,000/- M/s Gilead. compliant as 2016
Road, Lahore. Amphotericin B As per SRO. Local. per COPP. Deferred as the
M/s. United USP……50mg Anfogen Free sales product does not
Biotech (P) Ltd., Antifungal 50mg, issued dated fall in the
Village Ferozsons 26-02-2016. priority list.
Bagbania, Manufacturer’s GMP valid Moreover Anti-
Baddi-Nalagarh Specifications upto 17-09- fungal drugs are
Road, District- 24 months 2017. not importable
Solan (H.P) from India as
174101, India. per Import
Policy order
2016
Evaluation by PEC
Firm has stated as under:
i. The applied product is a new molecule and used in immunocompromised cancer patients as a
support therapy like Zolendronic acid & Ondansetron injection and the product is anti-fungal drugs
used to treat the invasive life threatening debilitating diseases.
ii. Anti-fungal drugs are importable from India as per import policy Order 2016 as the antifungal
drugs are not present in the list of items not importable from India
Previously in last meeting borad has deferred application of anti fungal class for confirmation of
importation status from India (as per import Policy Order) by Ministry of Commerce
Previous decision:
Registration Board in its 264th meeting deferred the case for following reason:
Deferred for confirmation whether applied formulation can be imported from India as per Import Policy
Order.
Evaluation by PEC:
Ministry of Commerce was requested through letter to confirm however they have asked for HS codes of
the product.
Decision: Deferred for the confirmation of importability status from India as per Import Policy
Order.
2. M/s. Revive Amphotin Lip-50 Form 5A MHRA. Abelcet Free sale 260th
Health Care, Injection Dy No. 614 5mg/ml issued Meeting
Office 503, 5th Each vial contains:- 31-12-2015 Amphotericin B dated 26- Registration
Floor, 6 Main Amphotericin B Lipid Rs.50,000/- lipid complex 02-2016. Board held
Gulberg, Jail Complex…50mg As per PRC (10ml, 20ml) COPP on 28-29th
Road, Lahore. (Antifungal) Concen. For valid upto June, 2016
M/s. United Manufacturer’s infusion by M/s 10-5- Deferred as
Biotech (P) Ltd., Specifications Teva. 2017 the product
Village 2 years Legalized does not fall
Bagbania, photocop in the
Baddi-Nalagarh y of GMP priority list.
Road, District- valid upto Moreover
Solan (Himachal 17-09- Anti-fungal
Pradesh) 2017. drugs are not
174101, India. importable
from India as
per Import
Policy order
2016
Evaluation by PEC
importation status from India (as per import Policy Order) by Ministry of Commerce
Previous decision:
Order.
Evaluation by PEC:
the product.
Order.
3. M/s AJ Mirza Pvt Phosome 50mg Form 5A MHRA. Ambisome COPP Deferred for
Ltd, 7-Ground Powder for Injection 08-04-2013 vide 50mg by M/s valid the
Floor, Shafi Court, Each vial contains:- diary No. 254 Gilead. upto 30- confirmation
Merewether Road, Liposomal Rs.100,000. Anfogen 50 mg, 12-2016. of
Civil Lines, Amphotericin As per PRC Ferozsons GMP importation
Karachi. B……………….50m valid status from
Manufactured by g upto 30- India as per
M/s Cipla Ltd, Plot Antifungal. 12-2016. Import
M-61, M-62 & M- Manufacturer’s Policy Order
63, Verna Specifications
Industrial Estate,
Verna Goa.
(99)
Previous decision:
Registration Board in its 263rd meeting deferred the case for following reason:
Deferred for the confirmation of importation status from India as per Import Policy Order.
Evaluation by PEC:
the product.
Order.
4. M/s. Revive Health Amphotin 50mg Form-5-A MHRA. Free sale 260th Meeting
Care, Office No.503, Injection Dy Fungizone issued dated Registration
5th Floor, 6 Main (Lyophilized) No.374 50mg 26-02-2016. Board held on
Gulberg, Jail Road, Each vial dated 04- powder for COPP valid 28-29th June,
Lahore. contains:- 05-2016 solution by upto 2016
M/s. United Biotech Amphotericin B Rs.50,000 M/s E.R GMP valid Deferred as the
(P) Limited, (Lyophilized)… /- & Squibb. upto 17-09- product does not
Bagbani, Baddi, …….50mg Rs.50,000 Local. 2017. fall in the priority
Nalagarh Road, (Anti-fungal) dated 24- Medinet list. Moreover
District, Solan, Manufacturer’s 06-2016. Anti-fungal
India. Specifications As per drugs are not
02 years SRO importable from
India as per
Import Policy
order 2016
Evaluation by PEC
importation status from India (as per import Policy Order) by Ministry of Commerce.
Previous decision:
Order.
Evaluation by PEC:
the product.
Order.
7. Varenecline, bupropion
1. 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 Nicline 1mg Tablets
Varenicline…………..1mg
Pharmacological Group Nicotinic acetylcholine receptor partial agonist/smoking
cessation aid
Type of Form Form-5
Pack size & Demanded Price 10’s; Not demanded
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.
Previous decision(s) Deferred in 274th meeting for submission of
● Latest GMP inspection report conducted within last
one year
● Revised master formula depicting correct quantity
of API.
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 with
correct quantity of API.
Previous decision: Registration Board in its 281st meeting deferred the case for
following reason:
For submission of fee for revision of master formulation.
Evaluation by PEC
Decision: Deferred for submission of fee for revision of master formulation.
2. Name and address of manufacturer / M/s Medizan Laboratories Pvt. Ltd. Plot No.313, Industrial
Brand Name +Dosage Form + Strength Bupion SR 75mg tablets
Bupropion hydrochloride………..75mg
Diary No. Date of R& I & fee Dy.No.1266;(06-10-2016);Rs.20,000/-(03-10-2016)
Type of Form Form-5
Pack size & Demanded Price 20’s; As decided by the Ministry of Health
Approval status of product in Reference Could not be confirmed in this strength as sustained release
Regulatory Authorities tablets
Me-too status (with strength and dosage Wellben SR 75mg tablet of M/s Bosch Pharmaceuticals,
form) Karachi
GMP status Last GMP inspection conducted on 20-11-2017 and the
report concludes that the firm was considered to be operating
at reasonably acceptable compliance with GMP guidelines as
of today.
Remarks of the Evaluator  Shortcomings:
meeting.
3. Name and address of manufacturer / M/s Bio Mark Pharmaceuticals, Plot No.527- Sunder
Applicant Industrial Estate, Lahore.
Brand Name +Dosage Form + Strength Zyban XL 150mg tablets
Bupropion (as hydrochloride)………..150mg
Type of Form Form-5
Pack size & Demanded Price 3x10’s; As per SRO (10% less than brand leader)
Approval status of product in Reference WELLBUTRIN XL 150mg tablets (USFDA approved) as
Regulatory Authorities 150mg salt
Me-too status (with strength and dosage Butrin XL 150mg tablet of M/s Genome Pharmaceuticals
form)
 Firm has applied for formulation containing 150mg
bupropion base while the reference product approved in
USFDA and MHRA contains 150mg bupropion
hydrochloride salt as the active ingredient.
 Latest GMP inspection report conducted within the period of
last one year.
Decision: Deferred for following submission:
 Revision of formulation containing 150mg bupropion base while the reference product
approved in USFDA and MHRA contains 150mg bupropion hydrochloride.
 Fee for revision of formulation.
 Registration Board referred the case to QA & LT Division to conduct GMP inspection of Firm on
priority.
4. Name and address of manufacturer / M/s Bio Mark Pharmaceuticals, Plot No.527- Sunder
Applicant Industrial Estate, Lahore.
Brand Name +Dosage Form + Strength Zyban XL 300mg tablets
Bupropion (as hydrochloride)………..300mg
Type of Form Form-5
Pack size & Demanded Price 3x10’s; As per SRO (10% less than brand leader)
Approval status of product in Reference WELLBUTRIN XL 300mg tablets (USFDA approved) as
Regulatory Authorities 150mg salt
Me-too status (with strength and dosage Butrin XL 300mg tablet of M/s Genome Pharmaceuticals
form)
 Firm has applied for formulation containing 300mg
bupropion base while the reference product approved in
USFDA and MHRA contains 300mg bupropion
hydrochloride salt as the active ingredient.
 Latest GMP inspection report conducted within the period of
last one year.
Decision: Deferred for following submission:
 Revision of formulation containing 300mg bupropion base while the reference product
approved in USFDA and MHRA contains 300mg bupropion hydrochloride.
 Fee for revision of formulation.
 Registration Board referred the case to QA & LT Division to conduct GMP inspection of Firm on
priority.
5. Name and address of manufacturer / M/s Theramed pharamaceuticals (pvt) Ltd, 45-Km
Applicant Multan Road Lahore Pakistan
Brand Name +Dosage Form + Strength B- Pion 75mg Tablet
Bupropion Hydrochloride (USP) ………..75 mg
Pharmacological Group Antidrepressant
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s As per DPC
Approval status of product in Bupropion Hydrochloride of USFDA approved
Me-too status (with strength and Budep 75mg of M/S Pharmatec
dosage form)
GMP status Last GMP inspection of Theramed Pharmaceuticals is
conducted on 10- 10- 17 and the report concludes that
panel recommends grant of renewal of DML and
Certificate of cGMP dated 10-10-2017
Decision: Approved.
Brand Name +Dosage Form + Strength B- Pion XR 150mg Tablet
Type of Form Form 5
Me-too status (with strength and Propin SR 150mg of M/S Genix Pharma
dosage form)
Certificate of cGMP dated . 10-10-2017
Decision: Approved.
Brand Name +Dosage Form + Strength B- Pion XR 300mg Tablet
Type of Form Form 5
Me-too status (with strength and Prop Ropion SR 300mg of M/S Searle Pak
dosage form)
Certificate of cGMP dated . 10-10-2017
Decision: Approved.
8. Name and address of manufacturer / M/s Wenovo Pharmaceuticals,
Applicant Plot # 31& 32 Punjab Small Industrial Estate Taxila.
Brand Name +Dosage Form + Strength Novoprop 150mg Tablet
Diary No. Date of R& I & fee Diary No:26458 , 28-12-2017 , Rs: 20,000/-
Composition Each prolonged release Tablet contains: -
Bupropion hydrochloride …150mg
Type of Form Form-5
Approval status of product in Reference Zyban 150 mg prolonged release tablets by M/s
Regulatory Authorities. GlaxoSmithKline UK (MHRA approved)
Me-too status Wellbutrin XL Tablets 150mg by M/s Glaxosmithkline
(Reg#047527)
GMP status Last inspection conducted on 19-10-2017 and report
concludes that firm is found complying GMP as of today.
Decision: Approved.
9. Name and address of manufacturer / M/s Wenovo Pharmaceuticals,
Applicant Plot # 31& 32 Punjab Small Industrial Estate Taxila.
Brand Name +Dosage Form + Strength Novoprop 300mg Tablet
Diary No. Date of R& I & fee Diary No:26459 , 28-12-2017 , Rs: 20,000/-
Type of Form Form-5
Approval status of product in Reference WELLBUTRIN XL (bupropion hydrochloride extended-
Regulatory Authorities. release) tablets 300mg by M/s Valeant Pharmaceuticals
(USFDA Approved)
Me-too status Butrin XL 300mg Tablets by M/s Genome Pharmaceuticals
(Pvt,) Ltd.(Reg#068383)
GMP status Last inspection conducted on 19-10-2017 and report
concludes that firm is found complying GMP as of today.
Decision: Approved.
10. Name and address of manufacturer / M/s Welwrd Pharmaceuticals,
Applicant Plot No. 03, Block –A, Phase-I,II, Industrial Estate, Hattar.
Brand Name +Dosage Form + Strength Wrdrop 150mg tablet
Diary No. Date of R& I & fee Duplicate copy where these particulars couldn’t be verified.
Type of Form Form-5
Approval status of product in Reference Zyban 150 mg prolonged release tablets by M/s
Regulatory Authorities. GlaxoSmithKline UK (MHRA approved)
Me-too status Wellbutrin XL Tablets 150mg by M/s Glaxosmithkline
(Reg#047527)
GMP status Last GMP inspection conducted on 14-06-2017 and the
report concludes that overall the firm is GMP compliant.
Remarks of the Evaluator.  Diary No. Date of R& I & fee:
Duplicate copy where these particulars couldn’t be
verified.
Firm has submitted complete fee PKR 20,000 dated 28-6-
2018
Decision: Deferred for verification of submission of application on 16-7-2014 in R&I DRAP.
11. Name and address of manufacturer / M/s Noa Hemis Plot #154, Sector 23, Korangi industrial area
Applicant Karachi.
Brand Name +Dosage Form + Strength Owenta 75mg SR Tablet
Bupropion hydrochloride ….75 mg
Diary No. Date of R& I & fee Dy.No. (R&I) 2641, 21-6-2016; Dy. No. R-II (690/6);
04-7-2016; Rs.20,000/- (21-06-2016)
Pharmacological Group Anti-depressant
Type of Form Form-5
Pack size & Demanded Price 14’s, 28’s ; As per PRC
Me-too status Qoby SR 75mg Tablets of M/s. Wilshire Laboratories
(Pvt) Ltd; (Reg.#065708)
Remarks of the Evaluator. Firm had initially applied for sustained release tablet, while
upon inquiring Evidence of approval of applied formulation by
any reference regulatory authority vide letter No. F.1-1/2017-
PEC-DRAP (AD PEC-II) dated 17-11-2017 firm has replied
as under:
“We had applied Owenta 75mg tablet mistakenly as a
sustained release tablet instead of immediate release tablet and
now we wish to revise our formulation and undertake that we
shall formulate our applied product Owenta 75mg tablet
(Bupropion HCl 75 mg) as immediate release tablet.”
Firm has also submitted revised master formulation for
immediate release tablet.
Following reference are available for Bupropion HCl 75 mg
tablet:
Butrin 75mg Tablets of M/s Genome Pharmaceuticals (Reg.#
068381)
Bupropion HCl 75 mg Tablets of M/s Mylan approved by
USFDA
Decision of 276th meeting of Registration Deferred for submission of fee of Rs. 20,000/- for change of
Board formulation.
Evaluation by PEC:
Firm has submitted fee chalan Rs. 20,000/-dated 28-6-2018 via fee challan 0727186
Decision: Registration Board approved the applied formulation as immediate release tablet detailed
as under:
“Owenta 75mg Tablet
Bupropion hydrochloride ….75 mg”
12. M/s Glitz Pharma, Plot No. Glitpro 150mg Form 5 Zyban® 150 mg Deferred for
265, Industrial Triangle Tablets 12-08-2014 prolonged release confirmation of
Kahota Road Islamabad Each tablet Dy No.3291 tablets formulation
contains:- Rs.8000/= Local Availability: whether modified
Bupropion Rs.12,000/= Wellburtin XL 150 mg release or otherwise
HCL ………. 07-06-2010 by M/s GSK Pakistan
150mg 1x10’s Last inspection report
2x10’s of 10-02-2016
3x10’s submitted with
5x10’s compliance remarks
10x10’s
As Per SRO
Previous decision:
Registration Board in its 263rd meeting deferred the case for following reason:
Deferred for confirmation of formulation whether modified release or otherwise.
Evaluation by PEC:
Decision: Deferred for revision of formulation along with fee since the reply of the firm is not clear
and the reference product is available as prolonged release tablet.
8. Tab. Nitrofurontoin 100 mg

1. Name and address of manufacturer / M/s Allmed (Pvt.) Ltd, Lahore
Applicant
Brand Name +Dosage Form + Strength Nitron tablet 100mg
Nitrofurantoin ……. 100mg
Diary No. Date of R& I & fee Initial R&I date:11-10-2012 (Photocopy) ;
Rs. 8,000/- 22-03-2011 (Photocopy)
Rs. 12,000/- 11-10-2012 (Photocopy)
Duplicate dossier dated 28-06-2018
Pharmacological Group Antibacterial for urinary pathogens
Type of Form Form-5 (Duplicate dossier)
Me-too status Anatrin Table of M/s Jupiter Pharma. (Reg.# 081913)
GMP status Latest GMP inspection report conducted on 13-09-
2017concluding satisfactory level of GMP compliance

Remarks of the Evaluator. Source of.
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.
2. Name and address of manufacturer / M/s Saibins pharmaceuticals, Plot No.316 Industrial
Applicant triangle, Kahuta road, Islamabad.
Brand Name +Dosage Form + Strength Noin 100mg tablets

Nitrofurantoin …… 100mg
Type of Form Form-5
Approval status of product in Reference Approved in MHRA and US-FDA
Me-too status (with strength and dosage Furantin 100mg tablets of M/s Geofman
form)
compliance to GMP.
Remarks of the Evaluator  Marketing status in USFDA: discontinued
 The official monograph of product exists in BP and USP.
 Shortcomings
 Clarification regarding whether the applied product
is film coated or uncoated tablets, and composition
of coating solution in case of coated tablets.
 Evidence of approval of applied formulation as film
coated tablets in reference regulatory
authorities/agencies could not be confirmed.
Decision of 273rd meeting of Registration Registration Board in its 273rd meeting deferred the case for
Board following reason:
 Clarification regarding whether the applied product
is film coated or controlled release tablets
 Composition of coating solution in case of coated
tablets.
 Evidence of approval of applied formulation as film
coated tablets in reference regulatory
authorities/agencies.
Evaluation by PEC:
Firm has submitted the following:
 Evidence of approval of applied formulation as uncoated tablet in MHRA
 Firm has submitted formulation of film coated tablet while the reference product is uncoated tablet
Decision: Deferred for revision of formulation as per the reference product along with submission
of fee for revision of formulation.
9. Metolazone 5 mg
1. Name and address of manufacturer / M/S Pharmatec Pakistan (Pvt) Ltd., D-86/A, S.I.T.E,
Applicant Karachi
Brand Name +Dosage Form + Strength Mila 10 mg tablets
Diary No. Date of R& I & fee Dy.No.23, 7-7-14, Rs. 50,000/-
Composition Each uncoated tablet contains:-
Metolazone (USP)……10 mg
Pharmacological Group Diuretic/saluretic/antihypertensive drug of the
quinazoline class
Approval status of product in Reference ZAROXOLYN Tablet 10 mg by M/s. UCB INC, USA.
Me-too status NA
GMP status Last GMP Inspection report is required
Remarks of the Evaluator. • Complete data of stability studies along with supporting
documents as per guidelines approved by registration
board.
Decision: Deferred for submission of stability study data along with associated documents as per
the requirements of 278th meeting of Registration Board and Registration Board referred the case
to QA & LT Division to conduct GMP inspection of Firm on priority.
2. Name and address of manufacturer / M/S Pharmatec Pakistan (Pvt) Ltd., D-86/A, S.I.T.E,
Applicant Karachi
Brand Name +Dosage Form + Strength Mila 5 mg tablets
Diary No. Date of R& I & fee Dy.No.608, 11-7-14, Rs. 50,000/- (Duplicate)
Metolazone (USP)……5 mg
quinazoline class
As per SRO
Me-too status NA
board.
the requirements of 278th meeting of Registration Board and Registration Board referred the case
to QA & LT Division to conduct GMP inspection of Firm on priority.
3. Name and address of manufacturer / M/S Getz Pharma (Pvt) Ltd., 29-30, Korangi
Applicant industrial area Karachi.
Brand Name +Dosage Form + Strength Metoxolyn tablet 2.5 mg
Metolazone (USP)……2.5 mg
quinazoline class
180/-
Approval status of product in Reference ZAROXOLYN Tablet 2.5 mg by M/s. UCB INC, USA.
Me-too status NA
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
board.
the requirements of 278th meeting of Registration Board.
Brand Name +Dosage Form + Strength Metoxolyn 10 mg tablets
Metolazone ……10 mg
quinazoline class
Pack size & Demanded Price 10’s,720/- for 10’s
Me-too status NA
board.
Brand Name +Dosage Form + Strength Metoxolyn 5 mg tablets
quinazoline class
Pack size & Demanded Price 10’s, 360/-
Me-too status NA
board.
rd
650
6. Name and address of manufacturer / M/s Biogen Pharma, 8km, Chakbeli Road, Rawat,
Applicant Rawalpindi
Brand Name +Dosage Form + Strength Metol Tablet 5mg
PKR 20,000/-: 15-4-2015 +
PKR 30,000/-: 21-4-2015
quinazoline class
Type of Form Form-5
Pack size & Demanded Price 10’s,20’s, 30’s, 100’s: As per SRO
Me-too status NA
Remarks of the Evaluator.  Stability study data as per the requirement of 278th
 Latest GMP inspection report conducted within a period
of 1 year
 Submission of application on Form 5-D
Decision: Deferred for application on Form 5-D along with submission of stability study data along
with associated documents as per the requirements of 278th meeting of Registration Board and
Registration Board referred the case to QA & LT Division to conduct GMP inspection of Firm on
priority.
7. Name and address of manufacturer / M/s Neutro pharma Pvt ltd 9.5km, Sheikhupura road,
Applicant Lahore
Brand Name +Dosage Form + Strength Metazone 2.5mg tablets
Metolazone….2.5mg
Me-too status
Remarks of the Evaluator. GMP inspection, Stability studies and all relevant documents
are not provided
Applicant Lahore
Brand Name +Dosage Form + Strength Metazone 5mg tablets
Metolazone….5mg
Me-too status
Remarks of the Evaluator. Stability studies and all relevant documents are not provided
Applicant Lahore
Brand Name +Dosage Form + Strength Metazone 10mg tablets
Metolazone….10mg
Me-too status
Remarks of the Evaluator. Stability studies and all relevant documents are not provided
10. Injection Phenobarbitone used in status epilepticus (Repeat)

11. Injection Phenobarbitone
1. Name and address of manufacturer / M/s Venus Pharma, 23 Km Multan Road, Lahore.
Applicant
Brand Name + Dosage Form + Strength Phenobarbital Injection 200mg/ ml
Phenobarbital Sodium …………….200mg
Pharmacological Group Barbiturate and derivatives (antiepileptic)
Finished product Specification B.P.
Pack size & Demanded Price 1ml x 5 amp, 1ml x 100 ampoules & Rs. 150/- , Rs.
250/-
Approval status of product in Reference Phenobarbital sodium Injection of M/s Aspen (Australia
Me-too status Phenobarb 200mg/ml of M/s Atco Pharma
the report concludes renewal of DML.
Remarks of the Evaluator  Renewal of injectable ampoule (Psychotropic)
section was done on 10-12-2014.
 Firm has not mentioned whether they have
applied as glass ampoules or plastic ampoules
while the reference approves glass ampoules.
Decision: Registration Board referred the case to QA & LT Division to conduct inspection of the
firm. Moreover, the firm needs to clarify the type of container closure system whether they have
applied as glass ampoules or plastic.
12. Inj flumazenil
1. Name and address of manufacturer / M/s Venus Pharma, 23 Km Multan Road, Lahore.
Applicant
Brand Name + Dosage Form + Strength Flumaze Injection 1mg/ 10ml
Composition Each ml glass ampoule contains:
Flumazenil …………....100mcg
Pharmacological Group Antidote
Type of Form Form- 5
Pack size & Demanded Price 10ml x 5’s & as per SRO
Approval status of product in Reference Flumazenil injection 1mg/ 10ml of M/s Westward
Regulatory Authorities. Pharms (USFDA Approved)
Me-too status Anexate injection of M/s Martin Dow (Reg.# 019493)
the report concludes renewal of DML.
Remarks of the Evaluator  2% overage is applied with justification of line
loss.
 Firm has liquid injectable (ampoule) section.
Decision: Registration Board referred the case to QA & LT Division to conduct inspection of
the firm and deferred the case for justification of use of 2% overage.
13. Tablet Perfenidone used in Interstitial Lung Disease

1. Name and address of manufacturer M/s Scilife Pharma Pvt Ltd, Plot # FD – 57/58-
/ Applicant A2,Korangi Creek Industrial Park (KCIP) Karachi.
Brand Name +Dosage Form + Pirfen 200mg Tablet
Strength
Pirfenidone ………..200 mg
Pharmacological Group Immunosuppressant (Idiopathic Pulmonary Fibrosis)
Type of Form Form 5
Finished product Specifications Manufacturers specification
Approval status of product in PMDA Japan Pirespa tablet 200mg
Me-too status (with strength and Not available
dosage form)
report concludes that firm is showing Good level of
compliance
Remarks of the Evaluator  Submitt application on form 5-D along stability
studies
 Application on Form 5-D along with submission of stability study data along with
associated documents as per the requirements of 278th meeting of Registration Board.
2. Name and address of manufacturer M/S Wilshire Laboratories (Pvt) Ltd. 124/1, Quaid-E-
/ Applicant Azam Industrial Estate,Kot Lakhpat, Lahore
Brand Name +Dosage Form + Xader 267mg Capsule
Strength
Pirfenidone ………..267mg
Pharmacological Group Anti-fibrotic agent
Type of Form Form 5-D
Pack size & Demanded Price 10’s, 20’s, 30’s, 50,s As per DPC
Approval status of product in Esbriet of USFDA approved
dosage form)
report concludes that firm is operating at satisfactory
level of compliance of GMP
Remarks of the Evaluator  Submitt stability studies
Decision: Deferred for submission of stability study data along with associated documents as
per the requirements of 278th meeting of Registration Board.
3. Name and address of manufacturer M/S Macter International Limited F-216, S..I.T.E.,
/ Applicant Karachi, Pakistan
Brand Name +Dosage Form + Fenid 267mg Tablet
Strength
dosage form)
report concludes that firm is found to be complying at
 The applied drug has been approved as “film coated
” while you have applied for the drug with out
coating, justification/clarification is required in this
required.
Decision: Deferred for revision of formulation as per the reference approved product along with
submission of fee and stability study data along with associated documents as per the
requirements of 278th meeting of Registration Board.
4. Name and address of manufacturer / M/S Macter International Limited F-216, S..I.T.E., Karachi,
Applicant Pakistan
Brand Name +Dosage Form + Fenid 801mg Tablet
Strength
dosage form)
report concludes that firm is found to be complying at
 The applied drug has been approved as “film coated
” while you have applied for the drug without
coating, justification/clarification is required in this
required.
Decision: Deferred for revision of formulation as per the reference approved product along with
submission of fee and stability study data along with associated documents as per the
requirements of 278th meeting of Registration Board.
5. Name and Address of Manufacturer / M/s Getz Pharma Pvt Ltd,
Applicant 29-30/ sector 27,Korangi Industrial Area, Karachi.
Brand Name + Dosage Form + Pirfen Tablets 267mg
Strength
Diary No. Date of R & I & fee Diary No:16073, 25/09/2017, Rs: 50,000/- (Challan#
0577275, Dated: 25/09/2017)
Pirfenidone …267mg
Pharmacological Group Other immunosuppressants
Approval Status of Product in ESBRIET (pirfenidone) film-coated tablets 267mg by M/s
Reference Regulatory Authorities. Genentech, Inc. (USFDA Approved)
Me-too Status N/A
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
stability study data for 3 batches as per Zone IV-A
6. Name and Address of Manufacturer / M/s Getz Pharma Pvt Ltd,
Applicant 29-30/27,Korangi Industrial Area, Karachi.
Brand Name + Dosage Form + Pirfen Tablets 801mg
Strength
0577274, Dated: 25/09/2017)
Me-too Status N/A
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
7. Name and Address of Manufacturer / M/s Genome Pharmaceuticals Pvt Ltd,
Applicant Plot # 16/1- Phase IV, Industrial Estate Hattar, Kpk,
Brand Name + Dosage Form + IPF Tablets 200mg
Strength
0279409, Dated: 09/03/2015)
Approval Status of Product in Pirespa tablet 200mg film-coated by M/s Shionogi &
Reference Regulatory Authorities. company. (PMDA Japan) Not confirmed.
Me-too Status N/A
GMP Status Last GMP inspection of 12-05-2018, good level of GMP
compliance
 Firm has not submitted real time and accelerated
 Submission of stability study data along with associated documents as per the requirements
of 278th meeting of Registration Board.
8. Name and Address of Manufacturer / M/s Helix Pharma (Pvt.) Ltd.,
Applicant Hakimsons House, A/56, S.I.T.E, Manghopir Road,
Karachi-75700
Brand Name + Dosage Form + Perfix Tablets 267mg
Strength
0610801, Dated: 20/07/2017)
Me-too Status N/A
GMP Status Last GMP inspection report dated 10-08-2017 concluding
satisfactory GMP compliance status.
 Alternate brand names:
Pirfen, Septa.
14. EMLA cream. Used to anesthetize skin for minor procedures (IV cannulation)
1. Name and address of manufacturer / M/s Seatle Pvt ltd, Multan road, Lahore
Applicant
Brand Name +Dosage Form + Strength Emlex Cream
Lidocaine……25mg
Prilocaine……..25mg
Pharmacological Group Local Anesthetic
Pack size & Demanded Price 5gm:Rs.550/-
10gm: Rs.1,100/-
20gm:Rs.2,200/-
30gm: Rs.3,300/-
Me-too status
GMP status Not Provided
Remarks of the Evaluator. GMP inspection, Stability studies data and relevant
documents are not provided
the requirements of 278th meeting of Registration Board along with latest GMP inspection report
within last 1 year.
2. Name and address of Applicant M/s. Medimark Pharmaceuticals
588-B/1, Liaquat Chowk Sahiwal
Detail of Drug Sale License Address: Medi Mark Oharmaceuticals 588-Karbala Road Liaqat
Chowk (Inside Al-Javaid children Clinic Sahiwal)
Name and address of manufacturer M/s Taiguk Pharm. Co. Ltd\
821, Geumbaek-daero, Chochon-myeon, buyeo-gun,
Chungcheongnam-do, Republic of Korea
Name and address of marketing M/s Taiguk Pharm. Co. Ltd\
authorization holder 821, Geumbaek-ro, Chochon-myeon, Buyeo-gun,
Chungcheongnam-do,
Name of exporting country Korea
Fee including differential fee Rs. 100000/- Dated 24/06/2016
Brand Name +Dosage Form + Anes Cream 10 g
Strength
Composition Each g contains:
Lidociane….25mg
Prilocaine…25mg
Pharmacological Group Local Anesthetic
Demanded Price Rs, 500/10g
Pack size 10g
International availability MHRA approved
Me-too status Could not be confirmed.
Detail of certificates attached Legalized CoPP (Scanned)
Certificate No. 2016-G1-0405
Certified by : Daejeon Regional Commissioner
The facilities and operations conform to GMP as recommended
by WHO.
GMP certificate No. 2016-G1-0036
Letter of authorization and sole agency agreement provided.
Remarks of the Evaluator. Stability studies according to condition of IVA are missing.
Provided data is at (25°C/60%RH).
Accelerated data is missing.
 Submission of realtime and accelerated stability study data as per the requirement of
Zone IV-A.
 Submission of original and legalized CoPP.
B. Pharmaceutical Evaluation Cell (PEC)
S.No. Detail
c. New cases
d. Deferred cases
e. New DML
f. New/Additional section(s)
g. Remaining Molecules of NL/NS
h. Deferred cases
iii. Human
c. Deferred
Case No. 04 Registration applications of categories to be considered on priority
d. Export Facilitation
e. Local manufacturing applications of priority categories defined by
f. Import applications of priority categories defined by Registration Board in its
257th meeting
Case No. 05 Registration applications of import cases
d. New Cases (Human)
e. Deferred cases
ii. Human
Case No. 06 Registration applications of drugs for which stability study data is required
to be verified
c. Onsite verification of stability data
d. Exemption from onsite verification of stability data
Total Cases: 180
a. New cases
Evaluator PEC-IV
Sr. Name & Brand Name Type of International Remarks Of Decision
No. Address of (Proprietary Form, Availability / Local Evaluator
Manufactur Name + Dosage Initial Diary Availability
er / Form + & Date, Fee
Applicant Strength), (including GMP Inspection
Composition, differential Report
Pharmacologica fee),
l Group, Demanded
Finished Price / Pack
Product size
Specification
1. M/s Filix Dynfix 50mg Dy No. 1460 Approved by Austria Approved with
Pharmaceutic Capsule 17-05-2013 innovator’s
als Islamabad Each capsule Rs. 20,000 Dicerin 50 mg specification
contains: capsule by Genome
Diacerin…….50 As per SRO Pharma
mg
Last inspection
NSAID conducted on 16-06-
analgesic 2017 and report
concludes that firm
Manufacturers is found complying
spec GMP.
2. M/s Filix Gabafix 50mg Dy No. 1627 Lyrica of (USFDA Approved with
Pharmaceutic Capsule 23-05-2013 approved) innovator’s
als Islamabad Each capsule Rs. 20,000 specification
contains: Gabica Capsule by
Pregabalin…… As per SRO M/s Getz Pharma
…..50 mg
Last inspection
Anti epileptic conducted on 16-06-
2017 and report
Manufacutrer concludes that firm
specifiction is found complying
GMP.
Pregabalin…… As per SRO M/s Getz Pharma
…..75 mg
Last inspection
Anti epileptic conducted on 16-06-
2017 and report
Manufacutrer concludes that firm
specifiction is found complying
GMP.
As per SRO M/s Getz Pharma
Pregabalin…… Last inspection
…..150 mg conducted on 16-06-
2017 and report
Anti epileptic concludes that firm
Manufacutrer is found complying
specifiction GMP.
5. M/s Filix Clarin 500mg Dy No. 1448 Klaricid of (MHRA Approved.
Pharmaceutic Tablets 17-05-2013 approved)
als Islamabad Rs. 20,000
Each film coated Respect tablet M/s
tablet contains: As per SRO Spencer
Clarithromycine Pharmaceutical
……….500 mg
Last inspection
Antibiotic conducted on 16-06-
2017 and report
USP concludes that firm
is found complying
GMP.
6. M/s Filix Lumix Dy No. 1457 WHO prequalified Approved.
Pharmaceutic 80/480mg 17-05-2013
als Islamabad Tablets Rs. 20,000 Artem Ds Plus
Tablet by M/s Hilton
Each tablet 1 x 10’s Pharmaceuticals
contains: As per SRO
Artemether……. Last inspection
.80mg conducted on 16-06-
Lumefantrine… 2017 and report
……480mg concludes that firm
is found complying
Anti-malarial GMP.
International
Pharmacopoeia
7. M/s Filix Pzol 40 Tablets Dy No. 1458 Pantoprazole 40 mg Approved.
Pharmaceutic Each enteric 17-05-2013 Tablet Of ( MHRA
als Islamabad coated tablet Rs. 20,000 Approved)
contains:
Pantoprazole (as 1 x 14’s Pantopraz 40mg
sodium Tablet M/s Klifton
sesquihydrate) As per SRO Pharma,
……….40mg
Last inspection
Proton pump conducted on 16-06-
inhibitor 2017 and report
concludes that firm
USP is found complying
GMP..
8. M/s Filix Lonfix 4mg Dy No. 1625 Xefo 4 mg Film Approved with
Pharmaceutic Tablets 23-05-2013 tablet (EMA innovator’s
als Islamabad Each film tablet Rs. 20,000 Approved) specification
contains:
Lornoxicam 1 x 10’s Reccam Tablet 4 mg
……….4mg Of M/s Regal
As per SRO Pharmaceuticals
NSAID
rd
661
Last inspection
Manufacturer conducted on 16-06-
spec 2017 and report
concludes that firm
is found complying
GMP.level of GMP
compliance.
9. M/s Filix Lonfix 8mg Dy No. 1628 Xefo 8 mg Film Approved with
Pharmaceutic Tablets 23-05-2013 tablet (EMA innovator’s
als Islamabad Each film tablet Rs. 20,000 Approved) specification
contains:
Lornoxicam 1 x 10’s Reccam Tablet 8 mg
……….8mg Of M/s Regal
As per SRO Pharmaceuticals
NSAID
Last inspection
Manufacturer conducted on 16-06-
spec 2017 and report
concludes that firm
is found complying
GMP.
10. M/s Cefkan 400mg 30-06-2015  Contract  Approved with
Xenon Capsule Rs. 50,000 Suprax capsule of manufacturing innovator’s
Pharmaceutic Each capsule (Duplicte (USFDA Approved) agreement:Att specification
als Pvt Ltd. contains: Dossier) achedof dated
Toll By M/s Cefixime As Mixime 400mg : 03-04-2013
Shrooq 5’s
trihydrate (USP) Capsule of M/s and valid for 3
Pharmaceutic As per SRO Mission years from the
als Pvt Ltd. Cephalosporin date of
Last inspection of registeration
Manufactures Xenon of products
spec pharmaceuticals  Number of
Was conducted on sections of
16-02-2017 and applicant
report concludes that approved by
panel recommend Licensing
renewal of DML . Board : 10
& Number of
Last inspection of products
Sharooq already
pharmaceuticals registered/app
Was conducted on roved on
07-06-2017 & 30- contract
08-2017 and report manufacturing
concludes that panel in the name of
recommend renewal applicant: 11
of DML .
11. Name and address of manufacturer / M/s Schazoo Pharmaceutical Laboratories (Pvt) Limited, 20km
Applicant Lahore-jaranwala road, District Sheikhupura.
Brand Name + Dosage Form + Strength Artemex Plus Dry Powder for oral suspension 15ml
Artemether ……….30mg
Lumefantrine…….180mg
Pharmacological Group Anti-malarial
Pack size & Demanded Price Rs. 66.67/-per 5ml, Rs. 200/pack per 15ml
Me-too status Co- misomal Dry suspension 15ml of M/s Tabros Pharma (Pvt)
Limited
report concludes good level of GMP compliance.
Remarks of the Evaluator  Firm has oral dry powder suspension section.
 The availability of the applied formulation could not be
confirmed in the reference regulatory authorities.
 Firm has applied three different volumes separately of
same formulation and same strength.
Artemether……………......30mg
Lumefantrine …………...180mg
Pharmacological Group Anti- malarial
Pack size & Demanded Price Rs. 50/- per 5ml, Rs. 300/- per 30ml
Me-too status Artem Plus 30/ 180 Dry suspension 30ml of Hilton Pharma
(Reg. # 066963)
Artemether……………….30mg
Lumefantrine ……….…..180mg
Pharmacological Group Anti- malarial
Pack size & Demanded Price Rs. 33.34/ 5ml, Rs. 400/pack (60ml)
Me-too status Arther DS suspension 30/180mg (60ml) of M/s Focus and Rulz
14. Name and address of manufacturer / M/S Demont Reasearch Laboratories 20KM, Lahore- Sharikpur
Applicant Road, Sheikhupura, Pakistan
Brand Name +Dosage Form + Strength Deline 400mg Tablet
Composition Each tablet contain
Doxofylline… …….400mg
Pharmacological Group Anti asthamtic
Type of Form Form 5
Finished product Specifications Manufacture’s Specification
Approval status of product in Doxofillina ABC 400 Mg Tablet Of ( AIFA Italy Approved)
Me-too status (with strength and Profylline Tablet Of M/S Kaizen
dosage form)
report concludes that overall firm has satisfactory compliance
of GMP
Remarks of the Evaluator  Firm change from film coating to uncoated without fee.
Decision: Deferred for submission of fee for revision of formulation
Brand Name +Dosage Form + Strength Spacinol Plus Tablet 80mg/80mg
Phloroglucinol……..80mg
Trimethylphloroglucinol………80mg
Pharmacological Group Gastrointestinal Anticholinergics/Antispasmodics
Type of Form Form 5
Pack size & Demanded Price 3 x 10’s, ; As per SRO
Approval status of product in Spasfon Tablet (ANSM Approved)
Me-too status (with strength and Spasrid Tablet of M/s Barrett Hodgson Pakistan (Pvt)
dosage form) Ltd
the report concludes resumption of production operations
accordingly
Brand Name +Dosage Form + Strength Winpine tablet 100mg
Quetiapine (as fumarate)….......100mg
Type of Form Form-5
Me-too status (with strength and dosage Qusel tablet 100mg of M/s Hilton Pharma
form)
Brand Name +Dosage Form + Strength Winpine tablet 25mg
Quetiapine (as fumarate)….......25mg
Type of Form Form-5
Me-too status (with strength and dosage Qusel tablet 25mg of M/s Hilton Pharma
form)
Brand Name +Dosage Form + Strength Misowin tablet 200mcg
Misoprostol as 1% HPMC dispersion........200mcg
Pharmacological Group Prostaglandin E1 analogue/ anti-ulcerant
Type of Form Form-5
Approval status of product in Reference Cytotec (MHRA approved)
Me-too status (with strength and dosage Cytotol 200mcg tablet of M/s Saffron pharmaceutical
form) company
Decision: Approved.
Brand Name +Dosage Form + Strength Dioswin sachet 3gm
Dioctahedral smectite….......3gm
Pharmacological Group Anti-diarroheal
Type of Form Form-5
Pack size & Demanded Price 30’s; As fixed by Govt.
Approval status of product in Reference ANSM approved
Me-too status (with strength and dosage Nexdrol 3gm sachet of M/s Nexus Pharma Karachi (Reg.#
form) 081590)
Remarks of the Evaluator Firm has approved sachet (General) section.
Decision: Approved.
Brand Name +Dosage Form + Strength Winsartan tablets 150mg
Irbesartan….......150mg
Pharmacological Group Angiotensin-II receptor antagonist
Type of Form Form-5
Pack size & Demanded Price As per SRO ; As per SRO
Me-too status (with strength and dosage Arbi 150mg tablet of M/s PharmEvo
form)
Decision: Approved.
Brand Name +Dosage Form + Strength Winsartan tablets 300mg
Irbesartan….......300mg
Pharmacological Group Angiotensin-II receptor antagonist
Type of Form Form-5
Me-too status (with strength and dosage Arbi 300mg tablet of M/s PharmEvo
form)
Decision: Approved.
22. Name and address of manufacturer / M/s Dyson Research Laboratories (Pvt.) Ltd., 28 Km
Applicant Ferozepur Road, Lahore.
Brand Name +Dosage Form + Strength Dygab capsules 75mg
Pregabalin….......75mg
Type of Form Form-5
Approval status of product in Reference Lyrica (USFDA approved)
Me-too status (with strength and dosage Balin capsule 75mg of M/s Regal Pharmaceuticals (Reg.#
form) 081971)
GMP status Last inspection conducted on 01-08-2017 with satisfactory
GMP compliance.
Decision: Approved.
23. Name and address of manufacturer / M/s Weather Folds Pharmaceuticals, Plot No. 69/2, Phase-II,
Applicant Industrial Area, Hattar.
Brand Name +Dosage Form + Strength Glucinol tablet 80mg/80mg
Hydrated Phloroglucinol 80mg corresponding to anhydrous
Phloroglucinol….......62.233mg
Trimethylphloroglucinol….......80mg
Pharmacological Group Anti-spasmodic
Type of Form Form-5
Pack size & Demanded Price As per SRO; As fixed by Govt.
Approval status of product in Reference SPASFON (ANSM approved)
Me-too status (with strength and dosage Spasfon tablets of M/s Himont
form)
GMP status GMP report of M/s Weather folds, dated 15-09-2017
concluding GMP compliant status.
Decision: Approved.
24. Name and address of manufacturer / M/s Cirin Pharmaceuticals (Pvt.) Ltd., 32/2-A, Phase-III,
Applicant Industrial Estate Hattar, District Haripur, KPK.
Brand Name +Dosage Form + Strength Varox tablets 20mg
Rivaroxaban….......20mg
Diary No. Date of R& I & fee Duplicate dossier; Dy. No.21692; 27-02-2017; Rs.20,000/-
(27-02-2017) Duplicate fee challan
Pharmacological Group Factor Xa inhibitor
Type of Form Form-5
Pack size & Demanded Price 7’s, 10’s and 14’s; As per SRO
Me-too status (with strength and dosage Xarelto 20mg of M/s Bayer Pakistan (Reg.# 072550)
form)
GMP status Last inspection conducted on 07-05-2018 with good GMP
compliance.
letter.
Brand Name +Dosage Form + Strength Hivoxat tablets 200mg
Flavoxate hydrochloride….......200mg
Pharmacological Group Urinary Antispasmodic
Type of Form Form-5
Me-too status (with strength and dosage Cleanxate tablet 200mg of M/s Rehman Medicines Co
form) Peshawar (Reg.# 019585)
Decision: Approved.
26. Name and address of Manufacturer / M/s. Shrooq Pharmaceuticals (Pvt) Ltd, 21 km, FerozPur
Brand Name+ Dosage Form+ Strength Thiosid injection 4 mg/2 ml
Thiocolchicoside…...4mg
Diary No. Date of R&I & fee Dy No. 19803 ; 11-4-14; Rs.20,000/- (Duplicate)
Type of Form Form-5
Finished Product Specification Innovator
Pack Size & Demanded Price 2ml, 6’s;
As per SRO
Approval status of product in Reference Thiocolchicoside injection(ANSM France Approved)
Me-too status Muscoril injection of M/s Sanofi
GMP status Latest GMP dated 30-8-2017, concluded renewal of drug
manufacturing license.
Brand Name+ Dosage Form+ Strength Kerooq injection 30 mg/ml
Composition Each ampoule contains:-
Ketorolac Tromethamine……..30mg
Diary No. Date of R&I & fee Dy No. 19802 ; 11-4-14; Rs.20,000/- (Duplicate)
Type of Form Form-5
Pack Size & Demanded Price 5’s /As per DRAP policy
Approval status of product in Reference Ketoroac of Hospira (USFDA)
Me-too status K-Dol of Akson
Brand Name+ Dosage Form+ Strength Tramarooq injection
Tramadol HCl-------100mg
Diary No. Date of R&I & fee Dy No. 19800 ; 11-4-14, Rs.20,000/- (Duplicate)
Pharmacological Group Opiate analogue/Analgesic
Type of Form Form-5
Pack Size & Demanded Price 5’s /As per DRAP policy
Approval status of product in Reference Zamadol Injection 50mg/ml Approved by (MHRA)
Me-too status PANTRA injection by GETZ PHARMA.
29. Name and address of manufacturer / M/s Wellborne Pharmachem and Biologicals, Plot No. 51/1,
Applicant 52/2 phase I & II, Industrial Estate, Hattar.
Brand Name +Dosage Form + Strength Linzo 600 mg tablet
Linezolid ...................................600mg
Pharmacological Group Macrolide (Antibiotics)
Form Form-5
Me-too status Ecasil tablet of M/s Sami Pharmaceuticals
(Reg. # 066904)
GMP status Last GMP inspection was conducted on 27-6-2018 concluded
good GMP.
Decision: Approved
Brand Name +Dosage Form + Strength Colotek injection
Colistimethate Sodium (Lyophilized powder for
reconstitution….. (1 Million IU)
Form Form-5
Approval status of product in Reference Colistimethate sodium 1 MIU, powder for solution for
Regulatory Authorities injection by M/s Panmedica (MHRA Approved) Each vial
contains 1 million International Units (IU) which is
approximately equivalent to 80 mg of colistimethate sodium.
Me-too status Colistat powder for Injection 1MIU by M/s Medisure
Lab (Reg#076160)
good GMP.
Decision: Defered for confirmation of manufacturing facility for “Lyophilization Injection (General)
section”
Brand Name +Dosage Form + Strength Gablin 50 mg capsule
Pregabalin....50mg
Form Form-5
Approval status of product in Reference Lyrica 50mg Capsule by M/s PF Prism CV, (USFDA
Regulatory Authorities approved)
(Reg#048725)
good GMP.
Brand Name +Dosage Form + Strength Gablin 75 mg capsule
Pregabalin....75 mg
Form Form-5
Approval status of product in Reference Lyrica 75 mg Capsule by M/s PF Prism CV, (USFDA
Regulatory Authorities approved)
Me-too status Gabica 75 mg Capsule by M/s Getz Pharmaceuticals.
(Reg#048725)
good GMP.
33. Name and address of manufacturer / M/s Mediate Pharmaceuticals, Karachi.
Applicant
Brand Name +Dosage Form + Strength Medbionta injection

Ascorbic acid … 500mg
Dexpanthenol …… 25mg
Nicotinamide ……. 100mg
Vitamin B6 …… 15mg
Vitamin B2 …… 10mg
Vitamin A ……. 10,000IU
Vitamin B1 ….. 50mg
Vitamin E ….. 5mg
Pharmacological Group Vitamin supplement
Type of Form Form-5
Me-too status Multibionta Infusion Inj. of M/s Merck (Reg.# 004158)
GMP status Last Inspection conducted on 15-12-2017and report
concludes that firm is operating at an acceptable level of
GMP compliance.
meeting.
 Upon communication of above observation firm has
referred to following product:
“Multibionta Solution for infusion 10 ml Ampoule” of M/s
“Merck Serono Ltd.”
https://myhealthbox.eu/en/medicine/multibionta/4201734
 The above cited reference of product and weblink submitted

by firm could not be verified from any reference regulatory
authorities
authorities/agencies which were adopted by the Registration Board in its 275th meeting as submitted
reference could not be verified.
Applicant RCCI, Rawat Rawalpindi contract manufacturing by M/s
Wellborne Pharmachem & Biologicals, Hattar
Brand Name +Dosage Form + Strength Rupin 500mg injection IM/IV
Ceftriaxone (as sodium) ………….. 500mg
Type of Form Form-5
Me-too status Kingcef 500mg Injection by Saydon Pharmaceutical Industries
(Pvt) Ltd, Peshawar. (Reg.#036942)
GMP status Last GMP inspection of M/s Wellborne Pharmachem &
Biologicals, Hattar conducted on 27-06-2018 ,and the
report concludes that firm operates under good level of cGMP
Decision: Registration Board approved the application and directed the firm to select either I/M or
I/V route of administration and Board authorized its Chairman for the issuance of registration letter.
Brand Name +Dosage Form + Strength Rupin 250mg injection IM/IV
Type of Form Form-5
Brand Name +Dosage Form + Strength Rupin 1gm injection IM/IV
Ceftriaxone (as sodium) ………….. 1 gm
Type of Form Form-5
Me-too status Kingcef 1gm Injection by Saydon Pharmaceutical Industries
(Pvt.) Ltd, Peshawar. (Reg.#036943)
rd
672
Brand Name +Dosage Form + Strength Axio 40mg IV injection
Esomeprazole (as sodium) ………….. 40 mg
Type of Form Form-5
Me-too status Remep Injection 40 mg IV by M/s Aulton Pharmaceuticals,
(Reg.#080570)
Remarks of the Evaluator. Firm has “Liquid injectable including lyophilisarion” (General
section)
Decision: Deferred for evidence of required manufacturing facility of “Liquid injectable including
lyophilisarion” (General section), approved by CLB.
38. Name and address of manufacturer / Neomedix, Plot 5, Street N-5, RCCI Industrial Estate, Rawat
Applicant contract manufacturing by M/s Wellborne Pharmachem and
Biologicals, Plot No.51/1 – 52/1, Phase-II, Industrial Estate,
Hattar.
Brand Name +Dosage Form + Strength Neocef 1gm injection IM/IV

Ceftriaxone (as sodium) ………….. 1 gm
Type of Form Form-5
Me-too status Kingcef 1gm Injection by Saydon Pharmaceutical Industries
(Pvt.) Ltd, Peshawar. (Reg.#036943)
39. Name and address of manufacturer / Neomedix, Plot 5, Street N-5, RCCI Industrial Estate, Rawat.
Hattar.
Brand Name +Dosage Form + Strength Neocef 500mg injection IM/IV

Type of Form Form-5
rd
673
40. Name and address of manufacturer / Neomedix, Plot 5, Street N-5, RCCI Industrial Estate, Rawat.
Hattar.
Brand Name +Dosage Form + Strength Neocef 250mg injection IM/IV

Type of Form Form-5
41. Name and address of manufacturer / M/s Elite Pharma Pvt Ltd., P.D.H. Street 9.5 km Sheikhupura
Brand Name +Dosage Form + Strength Kanaderm-N cream
Dexamethasone (as Sodium Phosphate) ..........1mg
Neomycin Sulphate ....................3500IU
Pharmacological Group Anti inflammatory/Antibiotic
Type of Form Form-5
Pack size & Demanded Price 1’s; Rs. 30.99
Me-too status Primadex-N Cream of M/s Prime Laboratories (Pvt) Ltd (Reg.#
029356)
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. Evidence of international availability submitted by firm could
not be verified from any reference regulatory authority.
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
 Updated status of GMP of the firm form QA & LT division as inspection report submitted
by firm does not conclude GMP compliant status
42. Name and address of manufacturer / M/s Glitz Pharma , Plot No 265,Industrial Triangle, Kahuta
Applicant Road, Islamabad
Brand Name +Dosage Form + Strength Chaien Syrup
Composition Each 5 ml of syrup contains:
Pizotifen (as hydrogen maleate)………….0.25 mg
Thiamine hydrochloride………0.875
Riboflavin phosphate…….1.31mg
Pyridoxine hydrochloride……..0.77mg
Nicotinamide…………5.25mg
Pharmacological Group Vitamin
Type of Form Not available
Pack size & Demanded Price 60ml, 90 ml, 120 ml & 240 ml; As per policy of MOH.
Me-too status Mosegor-V syrup of M/s Novartis Pharma.
GMP status Last inspection report dated 19-09-2017, panel recommended
the grant of cGMP certificate
Remarks of the Evaluator. Evidence of approval of applied formulation in reference
by the Registration Board in its 275th meeting as submitted
reference is not verifiable.
43. Name and address of manufacturer / M/s Hudson Pharma (Pvt.) Ltd., Plot No. D-93, North Western
Applicant Industrial Zone, Port Qasim, Karachi.
Brand Name +Dosage Form + Strength Sertoson Cream 2%
Sertaconazole nitrate……….20mg
Diary No. Date of R& I & fee 12982, 06-04-2018, Rs.50,000/- dated 17-01-2018
Type of Form Form-5
Finished product Specification Manufacturer’s specs
Pack size & Demanded Price 10gm; As per SRO
Me-too status Dermofix Cream 30gm of Ferrer Pharma (Reg#014083)
GMP status GMP inspection conducted on 11-12-2017, overall GMP
compliance of the firm with respect to building, facilities and
procedures demonstrated at the time of inspection found at
acceptable level.
Remarks of the Evaluator. The firm had initially applied on Form-5D with fee challan of
Rs. 50,000/-.
Now the firm has submitted application on Form-5 with fee
challan of Rs. 20,000/- and requested to consider the product as
generic me-too molecule.
Applicant
Brand Name +Dosage Form + Strength AMENEX INJECTION
Tranexamic acid………….500mg
Pharmacological Group Antifibrinolytic
Type of Form Form-5
Pack size & Demanded Price 5ml × 10 ampoules; As per SRO
Approval status of product in Reference Tranexamic aicd inj. 500mg/5ml solution for injectionof Focus
Regulatory Authorities. Pharma (MHRA approved)
Me-too status Hixamic injection of Himont Pharma (Reg#047937)
further.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength AMENEX-250 INJECTION
Tranexamic acid………….250mg
Pharmacological Group Antifibrinolytic
Type of Form Form-5
Approval status of product in Reference Transcermin Note 5% injection by M/s Daiichi Sankyo Co., Ltd
Regulatory Authorities. (PMDA Japan)
Me-too status Traxacid 250mg/5ml injection by m/s Asian (Reg#057865)
further.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength AMAANVIL INJECTION
Pheniramine maleate……………22.7mg
Pharmacological Group Antihistaminic and antiallergic
Type of Form Form-5
Approval status of product in Reference Avil Injection of sanofi Aventis
Me-too status Aavil Injection of Kakasian Pharma (Reg#058852)
further.
Applicant
Brand Name +Dosage Form + Strength KMART INJECTION
Artemether……………80mg
Type of Form Form-5
Finished product Specification International Pharmacopoeia specification
Approval status of product in Reference WHO approved Formulation
Me-too status Artinex Injection of Nexus Pharma (Reg#055032)
further.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength AMADOL INJECTION
Tramadol hydrochloride……………100mg
Pharmacological Group Analgesics, Opiates
Type of Form Form-5
Finished product Specification BP specification
Approval status of product in Reference Tramadol 50mg/ml solution for injection of AS Kalceks
Me-too status Tamadol 100mg/2ml Injection of Highnoon (Reg#013194)
further.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength CYANOCOBALAMIN INJECTION
Cyanocobalamin……..…….500mcg
Pharmacological Group Vitamin B-12 analogue
Type of Form Form-5
Pack size & Demanded Price 100 × 1ml ampoules; As per SRO
Approval status of product in Reference B-12 Injection in USA (not confirmed)
Me-too status Cyanobalamin Inj. 500mcg/ml of Multi Pharma (Reg#013207)
further.
Applicant
Brand Name +Dosage Form + Strength KAMI-SPA INJECTION
Drotaverine HCl…………..40mg
Pharmacological Group Vitamin B-12 analogue
Type of Form Form-5
Pack size & Demanded Price 25’s× 1ml ampoules; As per SRO
Me-too status NO-SPA Injection of Sanofi Aventis Pakistan
further.
51. 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 besilate……………..5mg
Valsartan…………………………80mg
Hydrochlorothiazide…………….12.5mg
Type of Form Form-5
Approval status of product in Reference Exforge HCT tablet of Novartis Pharma (Not confirmed)
Me-too status Tri-valsan 5/80/12.5mg tablet Hilton (Reg#067436)
GMP status GMP inspection report conducted on 20-11-2017 concluding
acceptable level of GMP compliance.
Remarks of the Evaluator. Approval status in reference country could not be verified.
52. Name and address of manufacturer / M/s. Welwrd Pharmaceuticals, Pakistan
Applicant
Brand Name +Dosage Form + Strength RELAXAWRD 4mg Tablet
Tizanidine as HCl………………..4mg
Pharmacological Group Skeletal muscle relaxant
Type of Form Form-5
Me-too status Tandolax 4mg Tablet of High-Q Pharmaceuticals
concludes that overall the firm is GMP compliant.
Decision: Approved.
53. Name and address of manufacturer / M/s Wellborne Pharmachem and Biologicals, Plot # 51/1, -52/1
Applicant phase I & II, Industrial Estate, Hattar
Brand Name +Dosage Form + Strength Ketoril 30mg Injection
Ketorolac Tromethamine…………30mg
Pharmacological Group Analgesic, anti-inflammatory
Type of Form Form-5
Pack size & Demanded Price 5’s ampoules ×1ml; As per SRO
Approval status of product in Reference Toradol Injection of Atnahs Pharma, UK (MHRA Approved)
Me-too status Toralac Injection 30mg/ml by M/s Vision Pharma
(Reg#050290)
GMP status GMP inspection dated 27-06-2018 showed that firm is
operating under good level GMP.
54. Name and address of Manufacturer / M/s Tabros Pharma Private Limited.
Applicant Fectory: L-20/B, Sector -22, Federal B Industrial Area, Karachi.
Brand Name + Dosage Form +Strength Misonate Injection 30mg IV
Artesunate…. 30mg
Diary No. Date of R&I & fee Dy No.11120; 04-08-2017; Rs.20,000/-
Pharmacological Group Anti-malarial
Type of Form Form-5
Finished Product Specification International Pharmacopoeia Specifications
Me-too status Gen-M by Genix Pharma
compliance.
Decision: Approved.
Applicant Fectory: L-20/B, Sector -22, Federal B Industrial Area,
Karachi..
Brand Name+Dosage Form+Strength Sodium Bicarbonate Injection 5% w/v IV/IM
Composition Each 0.5 ml contains:
Sodium bicarbonate…25 mg
Pharmacological Group Diluent for Misonate Injection 30mg
Type of Form Form-5
Finished Product Specification BP specifications
Pack Size & Demanded Price 0.5ml; As per SRO
Approval status of product in Reference WHO recommended formulation only for reconstitution of
Regulatory Authorities Artesunate Injection.
Me-too status Sodium bicarbonateInjection of Genix Pharma
compliance.
Remarks of evaluator Applied formulation is also present in USP.
Decision: Approved.
Applicant Fectory: L-20/B, Sector -22, Federal B Industrial Area,
Karachi.
Brand Name+Dosage Form+Strength Sodium Chloride Injection 0.9% w/v IV/IM
Composition Each 2.5ml contains:
Sodium chloride…22.5 mg
Pharmacological Group Diluent for Misonate Injection 30mg
Type of Form Form-5
Finished Product Specification BP specifications
Pack Size & Demanded Price 2.5ml; As per SRO
Me-too status Sodium Chloride Injection of Genix Pharma
compliance.
Remarks of evaluator Applied formulation is also present in USP.
Decision: Approved.
57. Name and address of Manufacturer / CCL Pharmaceuticals (Pvt.) Ltd. 62- Industrial Estate, Kot
Applicant Lakhpat Lahore.
Brand Name+Dosage Form+Strength Talam tablet 5/40mg.
Amlodipine(as besylate)…..5 mg
Telmisartan…. 40mg
Type of Form Form-5
Pack Size & Demanded Price 7×2’s, 1×10’s; As per SRO
Me-too status Ezitab-AM Tablet 5/40mg of M/s. Werrick Pharmaceuticals
compliance.
Decision: Deferred for clarification of applied dosage form since reference product is available as
uncoated tablet whereas firm has applied for film coated tablet.
Brand Name+Dosage Form+Strength Talam tablet 10/40mg.
Type of Form Form-5
compliance.
Brand Name+Dosage Form+Strength Talam tablet 5/80mg
Type of Form Form-5
compliance.
60. Name and address of Manufacturer / M/s Wilshire laboratories 124/1, Quid-e-Azam Industrial
Applicant Estate, Kot Lakhpat, Lahore.
Brand Name+Dosage Form+Strength Mirob tablet 25mg
Mirabegron….25mg
Pharmacological Group Beta-3 adrenergic agonists
Type of Form Form-5
Pack Size & Demanded Price 1’s, 5’s,10’s, 20’s, 30’s, 50’s; As per SRO
Approval status of product in Reference Approved in US-FDA(as extended release tablet )
GMP status GMP certificate based on evaluation conducted on 26-09-2017
Remarks of evaluator Evidence of me too with registration number.
Fee for revision of formulation from Mirabegron 25mg film coted tablet to Mirabegron 25mg
extended release tablet.
Submission of stability studies as the applied formulation is subsequent new drug generic version.
61. Name and address of Manufacturer / Wilshire laboratories 124/1, Quid-e-Azam Industrial Estate,
Applicant Kot Lakhpat, Lahore.
Brand Name+Dosage Form+Strength Mirob tablet 50mg
Mirabegron….50mg
Pharmacological Group Beta-3 adrenergic agonists
Type of Form Form-5
Approval status of product in Reference Approved in US-FDA(as extended release tablet )
Remarks of evaluator Evidence of me too with registration number.
Fee for revision of formulation from Mirabegron 25mg film coted tablet to Mirabegron 25mg
extended release tablet.
Submission of stability studies as the applied formulation is subsequent new drug generic version.
Brand Name+Dosage Form+Strength Xerbas tablet 10mg
Solifenacin succinate….10mg
Pharmacological Group Muscarinic antagonist
Type of Form Form-5
Me-too status Uricontrol 10mg Tablet of OBS Pharma Karachi
Brand Name+Dosage Form+Strength Nolazin tablet 500mg
Ranolazine….500mg
Pharmacological Group Anti-anginal
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 Approved in US-FDA(as extended release tablet)
Me-too status Rancard XR 500mg Tablet of The Searle Company
Decision:Deferred for submission of Form 5 in-line with reference product i.e. Ranolazine 500mg
extended release tablet & fee for revision of formulation.
Brand Name + Dosage Form +Strength Xerbas tablet 5mg
Solifenacin succinate….5mg
Pharmacological Group Muscarinic antagonist
Type of Form Form-5
Me-too status Uricontrol 5mg Tablet of OBS Pharma Karachi
Decision:Approved with innovator’s specification.
65. Name and address of Manufacturer / Aspin Pharma (Pvt) Ltd. Plot No. 10 & 25Sector 20, Korangi
Applicant Industrial Area, Karachi 74900, Pakistan.
Brand Name + Dosage Form +Strength Toricox tablet 60mg
Alternate Brand names:
Etoroid tablet 60mg
Etomat tablet 60mg
Rotixa tablet 60mg
Etoricoxib ….60mg
Pharmacological Group NSAID.
Type of Form Form-5
Pack Size & Demanded Price 7’s,10’s, 14’s, 28’s; As per SRO
Me-too status Etroxin tablet 60mg OF M/s Akson Pharmaceuticals Pvt Ltd,
Islamabad.
compliance.
Decision:Approved with innovator’s specification.
66. Name and address of manufacturer / M/s Seraph Pharmaceuticals, Islamabad
Applicant
Brand Name +Dosage Form + Strength Finsil 1% w/w Cream
Terbinafine HCl……10mg
Type of Form Form-5
Pack size & Demanded Price 15gm, 30gm As per PRC
Me-too status Bina 1.0% Cream by M/s Linta pharmaceuticals (Pvt) Limited
, Islamabad (Reg.# 080268)
GMP status 11-6-2018, The panel unanimously recommended issuance of
GMP Certificate.
Applicant
Brand Name +Dosage Form + Strength Sergiptin Plus tablets
Vildagliptin……50mg
Metformin HCl……850mg
Type of Form Form-5
Regulatory Authorities. Swiss-Medics Approved.
Me-too status GALVUS MET 50mg/850mg Tablets.
'NOVARTIS Pharma Stein AG, Switzerland. (Reg#066106)
GMP Certificate.
Decision: Approved with Innovator’s specifications with a shelf life of 18 months
Applicant
Brand Name +Dosage Form + Strength Ciprah 250mg tablet
Ciprofloxacin as HCl..……250mg
Type of Form Form-5
Regulatory Authorities. Ciproxin 250mgFilm-CoatedTablets by Bayer
Me-too status Ciprobid tablet 250mg of Nova pharmaceuticals
GMP Certificate.
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Ciprah 500mg tablet
Ciprofloxacin as HCl..……500mg
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)
GMP Certificate.
Decision:Approved
Applicant
Brand Name +Dosage Form + Strength Aziraph 250mg capsule
Azithromycin as dehydrate……250mg
Type of Form Form-5
Me-too status Azithromycin 500mg Capsules by Unipharma Pvt Ltd
GMP Certificate.
Remarks of the Evaluator. Approval of product in RRA could not be confirmed.
Decision: Approved.
71. Name and address of manufacturer / M/s Polyfine Chempharma, Peshawar
Applicant
Brand Name +Dosage Form + Strength Forome Eye drops Ophthalmic solution
Fluorometholone……1mg
Pharmacological Group Ant inflammatory agent
Type of Form Form-5
Approval status of product in Reference FML 0.1% Opthalmic Suspension USFDA Approved
Me-too status Fml Ophthalmic Susp 0.1%vby Barette Hodgson
GMP status 7-2-2018, Firm was considered to be operating at acceptable
level of compliance with GMP guidelines.
Remarks of the Evaluator. Firm has Eye drop general/Antibiotic section.
Reference regulatory approved product and me-too is in
Suspension Ophthalmic drops. While firm has applied as
Ophthalmic Solution.
72. Name and address of manufacturer / M/s Polyfine Chempharma, Peshawar
Applicant
Brand Name +Dosage Form + Strength Forome Forte Eye drops Ophthalmic solution
Fluorometholone……2.5mg
Pharmacological Group Ant inflammatory agent
Type of Form Form-5
Approval status of product in Reference FML FORTE 0.25% Opthalmic Suspension USFDA
Regulatory Authorities. Approved
Me-too status Flometh Ophthalmic Suspension Fluorometholone
………....0.25% Reg # 058071
GMP status 7-2-2018, Firm was considered to be operating at acceptable
level of compliance with GMP guidelines.
Remarks of the Evaluator. Firm has Eye drop general/Antibiotic section.
Reference regulatory approved product and me-too is in
Suspension Ophthalmic drops. While firm has applied as
Ophthalmic Solution.
Decision: Decision: Deferred for following:
73. Name and address of manufacturer / M/s Wellborne Pharmachem &Biologicals, Hattar, KPK
Applicant
Brand Name +Dosage Form + Strength Lorgesic 8mg tablets
Lornoxicam…..8mg
Type of Form Form-5
Approval status of product in Reference Xefo 8mg tablet (Swiss Medic approved)
Me-too status Zafon 8mg tablet of M/s Getz pharma
GMP status 27-6-2018 Firm is operating under good level of cGMP.
Applicant
Brand Name +Dosage Form + Strength Wsetron 8mg Injection
Ondansetron (as Ondansetron HCl Dihydrate)..…..8mg
Pharmacological Group 5-HT3 Receptor Antagonist
Type of Form Form-5
Me-too status ONDANLES I.V INJECTION Reg # 020704
Decision: Approved with change of brand name and innovator’s specification
Applicant
Brand Name +Dosage Form + Strength Wsetron 8mg tablet
Ondansetron as HCl dihydrate..…..8mg
Pharmacological Group 5-HT3 Receptor Antagonist
Type of Form Form-5
Me-too status Zofran tablet of M/s GSK
Decision: Approved with change of brand name and innovator’s specification
Applicant
Brand Name +Dosage Form + Strength Itorapid 50mg tablet
Itopride HCl..…..50mg
Type of Form Form-5
Approval status of product in Reference PMDA approved
Me-too status Ganaton 50mg tablet of Abbott
b. Deferred cases
77. Name and address of manufacturer / M/s Macquin’s International, Karachi
Applicant
Brand Name +Dosage Form + Strength Euro Suspension 125mg/5ml
Composition Each 5ml suspension contains:
Ciprofloxacin as HCl…..125mg
Type of Form Form-5
Pack size & Demanded Price 60ml, Rs.160/-
Approval status of product in Reference Ciproxin® 250 mg/5 ml granules and solvent for oral
Regulatory Authorities. Suspension byM/sBayerHealthcare,MHRAapproved.
satisfactory level of compliance with GMP guidelines.
Previous remarks of the Evaluator. 
Previous decision(s) Deferred for further deliberation regarding manufacturing
facility of diluent for reconstitution of ciprofloxacin suspension.
(M-275)
Evaluation by PEC Registration Board in 269 meeting decided to approve the
formulation of ciprofloxacin 125mg/5ml granules and solvent
for oral suspension as per reference product approved by
USFDA and MHRA
Decision: Deferred for clarification of applied composition since reference product contains
Ciprofloxacin as base only whereas firm has applied for Ciprofloxacin as hydrochloride
78. Name and address of manufacturer / M/s Macquin’s International, Karachi
Applicant
Brand Name +Dosage Form + Strength Euro DS dry suspension
Ciprofloxacin as HCl….250mg
Type of Form Form-5
Pack size & Demanded Price 60ml, Rs.260/-
Approval status of product in Reference Ciproxin 250 mg/5 ml granules and solvent for oral suspension
Regulatory Authorities. by M/s Bayer Healthcare, MHRA approved.
Me-too status Hiflox Dry suspension 250mg/5ml by M/s Hilton (Reg#067499)
satisfactory level of compliance with GMP guidelines.
Previous remarks of the Evaluator. Rs.8000/- fee challan is not attached.
Previous decision(s) Deferred for following:
 For deliberation in light of decision taken in 269th Registration
Board meeting regarding manufacturing facility of diluent for
reconstitution of ciprofloxacin suspension.
 Verificationof Fee challan of Rs. 8,000/-
Evaluation by PEC Registration Board in 269th meeting decided to approve the
formulation of ciprofloxacin 125mg/5ml granules and solvent
for oral suspension as per reference product approved by
USFDA and MHRA.
Photocopy of Fee challan of Rs. 8000/- has been submitted.
Decision: Deferred for clarification of applied composition since reference product contains
Ciprofloxacin as base only whereas firm has applied for Ciprofloxacin as hydrochloride.
79. Name and address of manufacturer / M/s CCL, Pharmaceuticals Pvt. Ltd. Lahore
Applicant
Brand Name +Dosage Form + Strength Telsartan Plus Tablets
Composition Each film coated tablet Contains:-
Telmisartan……..40mg
Hydrochlorothiazide…….12.5mg
Pharmacological Group Non-peptide angiotensin II receptor antagonist, diuretic
Type of Form Form-5
Pack size & Demanded Price 14’s,28’s & 56’s; As per brand leader
Me-too status Co-Telsan 40/12.5 Tablets by M/s Hilton Pharma, Karachi
(Reg.#047124)
GMP status Last inspection report dated 08-03-2017 & 31-03-2017, stating
Previous decision(s)  Deferred for clarification of dosage form as reference product
is available as bilayer tablet whereas firm has applied for
monolayer compressed tablet. (M-274)
Evaluation by PEC The firm has stated that
“It is submitted that the product is actually bilayer and applied
erroneously the monolayered. In this connection, we are pleased
to enclose the following revised documents of said registration
dossier:
1. Unit Formulation
2. Master Formulation and Manufacturing Procedure
3. Method of analysis
It is informed that we have installed tri-layer rotary tablet press
(ZPD25) manufactured by M/s Shanghai Tianxiang & Chentai
Pharmaceutical Machinery Co, Ltd China and the same was
inspected by a panel during GMP inspection on 20.04.2018 &
24.04.2018”.
Decision: Deferred for clarification/justification for applied dosage form since reference product is
available as uncoated tablet whereas firm has applied for film coated tablet.
80. Name and address of manufacturer / M/s. CCL Pharmaceuticals (Pvt.) Ltd. Lahore
Applicant
Brand Name +Dosage Form + Strength BPH Capsules
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
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.
th
Decision of 276 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 9th February, 2018, for verification of capsule filling
machine with reference to decision of the DRB in its 276th 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=searchGMPCResultControlLi
st&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 containing
Tamsulosin pellets. Currently 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 manufacturers having registered products of applied 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 Dutasteride soft gelatin capsule in the hard gelatin capsule shells will be processed in general capsule
section.
Composition of panel:
a. Additioanl Director DRAP (E&M) Office.
b. Area FID.
Details of Inspection:
M/s CCL Pharmaceuticals (Pvt.) Ltd., Lahore was visited by the panel on 24-05-2018 with reference to the
observations of Drug Registration Board about manufacturing requirement of BPH Capsule in its 281st meeting
conveyed vide DRAP, Islamabad vide letter No. F.13-11/2017-PEC dated, 10-05-2018. The premises were
previously inspected by the area FID on 09-02-2018 for verification of capsule filling machine and the report was
forwarded to DRAP, Islamabad which was evaluated and included in 281st meeting of Drug Registration Board.
The Board deliberated about manufacturing requirement for BPH capsule and made some observations and
constituted a panel for verification. The panel thoroughly inspected the area and the machine and verified the
observations as under:
a.) First observation was suitability of capsule filling machine. The performance of the machine was evaluated
during last inspection on 09-02-2018 and also by the panel on 24-05-2018 and the machine was found suitable for
the filling of BPH capsule.
b). Another observation was the cross contamination and environmental hazard in case of rupturing of soft
gelatin capsule, Relating to this issue it was noted that:
• Soft gelatin capsule filled with liquid dutasteride were received in Ready to Fill Form hence no chances of
exposure during filling.
• No powdery material in soft gelatin capsule.
• The capsule filling machine was dedicated by the firm for the applied product only.
•. Various trials were conducted by the firm for the filling of capsule and no incidence of rupturing of soft
gelatin capsule was recorded till date.
•. The differential pressure in the room was maintained i.e., Negative pressure from the corridor, so that the
air inside room would not go outside to the corridor, hence minimal chances of cross contamination and
environmental hazards.
c. Upon asking the cleaning procedure in case of rupture, the firm management informed that during the trial
batch, one capsule was ruptured intentionally and cleaning of machine / machine parts was carried out. The cleaning
verification was conducted utilizing the surface swab samples of machine base and rinse samples of product contact
parts. Full UV spectrum (210-400nm) of swab sample of machine base surface and rinse samples of Soft Gelatin
Capsule Hopper, Feeder and Filling Plates demonstrated satisfactory level of cleaning and no residue of dutasteride
and tamsulosin after filling was seen ( Annex-A).
d SOP for cleaning of semi-automatic capsule in capsule machine was available which outlines the detail of
cleaning procedure of this product and machine (Annex-B)
e. A risk assessment based on trial batches was also conducted by the firm that demonstrate minimal risk of
contamination during filling (Annex-C)
Conclusion:
Based on location, performance of Machine, cleaning procedure and risk assessment method the panel
concluded that encapsulation of Dutasteride Soft gelatin capsule and tamsulosin Pellets can be satisfactorily
achieved using Modified Semi-automatic Capsule Filling Machine and the chances of cross-contamination and
environmental hazards are minimal subject to regular in-process checks and strict process control.
Proceedings:
Dr. Amanullah Khan, Director DTL Balochistan / Member Registration Board has commented with Note
of Dissent on two cases as detailed below: -
Note of Dissent:
This point pertains to the cases of the two firms that is M/s CCL Pharmaceuticals (Pvt) Ltd Lahore and
M/s Getz Pharma Karachi, they both have applied for the registration of their product that is Capsule with
the composition containing Dutasteride….0.5mg and Tamsulosin HCl…0.4mg (Soft gelatin capsule filled
with liquid Dutasteride & Tamsolosin HCl extended release pellets). The registration board has already
given approval of the same combination product to M/s Global Pharmaceutical with steroidal section.
1) Dutasteride is a steroidal preparation and is being filled in the hard gelatin capsule in the general
capsule section, but as per policy of the Registration Board all the steroidal preparation are only approved
when the firm has steroidal Section , keeping in view the policy of the Registration Board, I am of the
opinion that as the said product contains Dutasteride which is a steroidal preparation and to ensure that
the area is safe for filling of the soft gelatin capsule in hard gelation capsule it is mandatory to use the
steroidal area for filling of the soft gelatin capsule in hard gelatin capsule instead of using general capsule
filling area for the filling of steroidal preparations.
The general capsule filling area can’t provide any guarantee about the cross contamination in case the soft
gelation capsule containing steroidal preparation gets rupture so there is no need to take high risk of cross
contamination and which will be proved fatal for the patients.
2) The import of soft gelatin capsule filled with liquid Dutasteride couldn’t be considered as API
because it’s in capsule form and ready for use and doesn’t fall under the definition of “half-finished
product”
“half –finished product means any material or mixture of materials that has to undergo further
manufacture”
3) It was also decided that all the above three firms will be inspected and accordingly their inspection
reports will be submitted and in particularly Global Pharma will be inspected to check whether they are
using steroidal area for filling of soft gelatin in hard gelatin capsule but in the last meeting, inspection
report of Global Pharma was not submitted so it’s better to wait for the inspection report of M/s Global
Pharma.
Keeping in view the above facts and safety of the patients I disagree with the grant of registration to both
the firms that is M/s CCL Pharmaceuticals (Pvt) Ltd Lahore and M/s Getz Pharma Karachi, for their
product containing (Soft gelatin capsule filled with liquid Dutasteride & Tamsolosin HCl extended release
pellets) for filling the capsule in general area.
Decision: Registration Board deliberated the matter in detail and approved the product considering the
findings of the panel regarding suitability of capsule filling machine and manufacturing area for production
of applied formulation.
81. Name and address of manufacturer / M/s Atco Lab. B-18, SITE. Karachi.
Applicant
Brand Name +Dosage Form + Strength Synal Topical solution 0.01%
Fluocinolone Acetonide ……. 0.1 mg(0.01% W/V)
Type of Form Form-5
Pack size & Demanded Price 60 ml , 120 ml,
rd
693
Rs.6000/-Per 60 ml,
Rs.12000/- per 120 ml
Approval status of product in Reference Fluocinolone Acetonide of Bausch And Lomb (USFDA)
Me-too status Derma-Smooth topical oil of M/s Valor Pharmaceuticals
(068638)
GMP status Panel inspection conducted on 28-2-2017 and report concludes
that firm is operating at the good GMP compliance.
Previous remarks of the Evaluator. The me-too reference submitted by firm as mentioned above is
of different dosage form than applied product
Previous decision(s)  At the time of dossier submission, actually the brand
name was inadvertently mentioned with the dosage form as
“topical solution” due to typographical error; however the
formula submitted clearly indicates the intended formulation is
“Topical Oil” rather than topical solution.
Evaluation by PEC
Decision: Approved.
82. Name and address of manufacturer / M/s CCL, Pharmaceuticals Pvt. Ltd. Lahore
Applicant
Brand Name +Dosage Form + Strength Telsartan Plus 80/12.5 Tablet
Telmisartan…………………..80mg
Hydrochlorothiazide………….12.5mg
Pharmacological Group Non-peptide Angiotensin Receptor (AT1) Antagonist
Type of Form Form-5
Pack size & Demanded Price As per Brand Leader
Approval status of product in Reference Micardis HCT of Boehringer Ingelheim, USFDA
Me-too status Micardis-H 80/12.5mg tablet of Maple Pharma
GMP status Panel Inspection for grant of GMP certificate conducted on 08-
03-2017 & 31-03-2017, the firm was found to be operating at a
Previous decision(s)  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. The Board further, decided to get clarification from
previous registration holders of same formulation. (M-277)
Evaluation by PEC The firm has stated that
“It is submitted that the product is actually bilayer and applied
erroneously the monolayered. In this connection, we are pleased
to enclose the following revised documents of said registration
dossier:
1. Unit Formulation
2. Master Formulation and Manufacturing Procedure
3. Method of analysis
It is informed that we have installed tri-layer rotary tablet press
(ZPD25) manufactured by M/s Shanghai Tianxiang & Chentai
Pharmaceutical Machinery Co, Ltd China and the same was
inspected by a panel during GMP inspection on 20.04.2018 &
24.04.2018.”
Decision: Deferred for clarification/justification for applied dosage form since reference product is
available as uncoated tablet whereas firm has applied for film coated tablet.
83. Name and address of manufacturer / M/s Getz Pharma,29-30/27, Korangi Industrial Area, Karachi
Applicant
Brand Name +Dosage Form + Strength Tamsolin plus capsule 0.4+0.5mg
Tamsulosin hydrochloride… 0.4mg
(as modified release pellets)
Dutasteride….0.5mg
(as soft gel capsule)
Pharmacological Group Alpha adrenoceptor antagonist,
5-Alpha reductase inhibitor
Type of Form Form-5
Finished product Specification Manufacturer Specifications
Pack size & Demanded Price 10’s, 30’s; Rs. As per PRC
Me-too status Duodart capsule of GSK
GMP status In last GMP inspection of M/s Getz pharma conducted on 11-12-
2013 the management has been advised to remain in the
adaptation and up gradation phase to cater all the requirements
OF cGMP guidelines.
Previous remarks of the Evaluator. Application has been evaluated by Pharmaceutical Evaluation
Cell and found deficient of following documents, stated below,
which were communicated to the firm and the firm has submitted
its reply and has requested for extension in timeline till
September 15, 2017 for submission of required documents as the
firm is in process of compiling the required documents.
i. Last GMP inspection report (which should have been
ii. Evidence of pharmacopoeial reference of finished
product specification. In case, the product is non
pharmacopoeial, provide product specification in the
light of decision taken in 267th meeting of Registration
Board.
iii. Commitments required as per decision of Registration
Board taken in its 251st meeting.
iv. Primary packaging material of applied formulation in
reference agencies is HDPE bottle while primary
packaging material of applied formulation is aluminum
blister, Justify.
v. Undertaking that the applied brand name is not similar
or has no resemblance (look alike- sound alike) with
already registered drugs.
vi. COA of API.
vii. GMP certificate of manufacturer of API.
viii. Stability studies both real time and accelerated of three
batches of pellets conducted in accordance with zone IV-
A conditions.
Previous decision(s) Deferred for the following (M-273):
i. Confirmation of manufacturing facility (steroid) for
manufacturing of Dutasteride soft gelatin capsule and
then filling of soft gelatin capsule into hard gelatin
capsules along with tamsulosin pellets.
ii. Last GMP inspection report conducted within the period
of last one year.
iii. Evidence of pharmacopoeial reference of finished
product specification. In case, the product is non
pharmacopoeial, provide product specification in the
light of decision taken in 267th meeting of Registration
Board.
iv. Primary packaging material of applied formulation in
reference agencies is HDPE bottle while primary
packaging material of applied formulation is aluminum
blister, Justify.
v. COA and GMP of pellet's manufacturer and stability
studies both real time and accelerated of three batches of
pellets conducted in accordance with zone IV-A
conditions.
Deferred for clarification regarding free sale status of Dutasteride
soft gel capsule in country of origin. (M-283)
●
Evaluation of PEC:
● The firm has stated that we have purchased and procured “ZIBO SMA Z Lab Capsule filling machine for
Soft Capsule and Pellet Filling” alongwith following documents confirming import of the said machine:
Copy of Airway Bill
Copy of Free Trade Area (FTA) Certificate
Copy of good declaration
Copy of ZIBO SMA Z Lab Capsule filling Machine Brochure
● The firm has provided capsule (General) section for manufacturing of applied formulation.
● GMP inspection dated 18-12-2017 shows acceptable level of compliance with GMP guidelines.
● Source of Tamsolusin HCl pellets 0.2% w/w: M/s RA Chem Pharma, Telangana, India
COA of Pellets,
Stability data of three batches
GMP certificate Issued by Drug Control Administration valid upto 06-07-2018.
● Source of Dutasteride soft gel capsules: M/s Jiangsu Vanguard Pharmaceutical Co., Ltd, China
COA of Pellets,
Stability study data of three batches.
GMP GMP Certificate issued by Jiangsu Food and Drug Administration, China valid upto 28-08-2019.
● The firm has submitted Justification for using Alu-Alu Blister packaging instead of HDPE. Alu-Alu Blister
packaging has several advantages over HDPE bottle. Alu-Alu blister provides optimal protection properties
by offering an impermeable barrier to light, ultraviolet rays, water vapour, oxygen and microorganisms.
When used to package sensitive products such as pharmaceuticals, aluminium is hygienic, non-toxic and
non-tainting. Each Alu-ALu blister is a single protection unit, no effect to barrier after opening first cavity.
● The firm has submitted pharmaceutical development studies, Analytical method validation report of
applied formulation.
● The firm replied that we will bulk import Dutasteride Soft Gel Capsules for further filling in HPMC
capsules along with Tamsulosin HCl modified release pellets and will pack in primary and secondary
containers at our local facility. Therefore, FSC cannot be arranged for Dutasteride Soft Gel Capsules as it
will not be imported as finished product.
Inspection Observations:
Inspection of M/s Getz Pharma (Pvt.) Limited Plot No. 29-30, Sector 27, Korangi Industrial Area Karachi
was conducted to confirm the suitability of semi-automatic capsule filling machine for manufacturing of
Tamsolin Plus (Tamsulosin HCl + Dutasteride) Capsules 0.4mg + 0.5mg as informed that the said
formulation involves filling of Dutasteride soft gelatin capsules into a capsule containing Tamsulosin HCl
modified release pellets. Following are the observations:
 Manufacturing process of Tamsolin Plus is summarized as; after loading of the capsules in
encapsulation machine i.e., ZIBO SMA Z LAB, first Tamsulosin HCl pellets will be filled in
capsules. After filling of Tamsulosin HCl pellets, soft gel capsules of Dutasteride will be filled in
same capsule, then filled capsules will be locked and ejected out.
 The firm has procured the double hopper encapsulation machine “ZIBO SMA Z LAB Capsule
Filling Machine” from China, for the manufacturing of Tamsolin Plus capsule (Annex-A).
 Documents pertaining to the approved protocols and record of qualification i.e. Design Qualification
(DQ), Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification
(PQ) were available and found adequate for the suitability of the desired function.
 As informed by the firm manufacturing of Tamsolin Plus will be performed in campaign and no
other product will be manufactured simultaneously with Tamsolin Plus, also no female worker or
officer will be involved in any step of manufacturing of the said product, also reflected in SOP PD-
CA-010 (Annex-B).
 In case of spillage of Dutasteride soft gelatin capsules during manufacturing, cleaning will be
performed as per validated cleaning procedure with reference to MSDS of Dutasteride (Annex-C).
 The area of encapsulation is qualified with dedicated air handling unit and is designed on “cascade
flow”, which ensures that area itself is not the source of cross-contamination, also the content of
Dutasteride in soft gelatin capsule is oil based non-volatile liquid, therefore, both area and product
does not pose risk of cross-contamination.
 Risk assessment documents were also seen in place to established measures and controls to mitigate
risks associated with the manufacturing of Tamsolin Plus with respect to spillage after rupturing,
cleaning, cross-contamination and environmental hazards.
Based on the observation made, areas inspected, people met and the documents reviewed and considering
the finding of inspection, it is concluded that:
Procured encapsulation machine is suitable for manufacturing of Tamsolin Plus capsule. Necessary controls
and measures are in place in case of spillage after rupturing of soft gelatin Dutasteride capsules. Moreover,
dedicated HVAC system and validated cleaning procedures are also available to avoid cross-contamination
and environmental hazards during the filling of Dutasteride soft gelatin capsules into a capsule containing
Tamsulosin HCl modified release pellets.
Proceedings:
Dr. Amanullah Khan, Director DTL Balochistan / Member Registration Board has commented with
Note of Dissent on two cases as detailed below: -
Note of Dissent:
This point pertains to the cases of the two firms that is M/s CCL Pharmaceuticals (Pvt) Ltd Lahore
and M/s Getz Pharma Karachi, they both have applied for the registration of their product that is
Capsule with the composition containing Dutasteride….0.5mg and Tamsulosin HCl…0.4mg (Soft
gelatin capsule filled with liquid Dutasteride & Tamsolosin HCl extended release pellets). The
registration board has already given approval of the same combination product to M/s Global
Pharmaceutical with steroidal section.
1) Dutasteride is a steroidal preparation and is being filled in the hard gelatin capsule in the
general capsule section, but as per policy of the Registration Board all the steroidal preparation are
only approved when the firm has steroidal Section , keeping in view the policy of the Registration
Board, I am of the opinion that as the said product contains Dutasteride which is a steroidal
preparation and to ensure that the area is safe for filling of the soft gelatin capsule in hard gelation
capsule it is mandatory to use the steroidal area for filling of the soft gelatin capsule in hard gelatin
capsule instead of using general capsule filling area for the filling of steroidal preparations.
The general capsule filling area can’t provide any guarantee about the cross contamination in case
the soft gelation capsule containing steroidal preparation gets rupture so there is no need to take high
risk of cross contamination and which will be proved fatal for the patients.
2) The import of soft gelatin capsule filled with liquid Dutasteride couldn’t be considered as API
because it’s in capsule form and ready for use and doesn’t fall under the definition of “half-finished
product”
“half –finished product means any material or mixture of materials that has to undergo further
manufacture”
3) It was also decided that all the above three firms will be inspected and accordingly their
inspection reports will be submitted and in particularly Global Pharma will be inspected to check
whether they are using steroidal area for filling of soft gelatin in hard gelatin capsule but in the last
meeting, inspection report of Global Pharma was not submitted so it’s better to wait for the
inspection report of M/s Global Pharma.
Keeping in view the above facts and safety of the patients I disagree with the grant of registration to
both the firms that is M/s CCL Pharmaceuticals (Pvt) Ltd Lahore and M/s Getz Pharma Karachi,
for their product containing (Soft gelatin capsule filled with liquid Dutasteride & Tamsolosin HCl
extended release pellets) for filling the capsule in general area.
Decision: Registration Board deliberated the matter in detail and approved the product considering
the findings of the panel regarding suitability of capsule filling machine and manufacturing area for
production of applied formulation.
Sr. Name and Brand Name Type of Approval Previous Evaluation by
No address of (Proprietary Form status in Decisions PEC
manufacture name + Initial date, Reference
r / Applicant Dosage Form diary regulatory
+ Strength) Fee agencies /
Composition including authorities
Pharmacolog differential Me-too status/
ical Group fee GMP status
Finished Demanded
product Price /Pack
Specification size
84. Medley Cinitamed Form 5 Spanish Deferred as The firm has
Pharmaceutic 1mg Tablets 11-04-2011 Agency of formulation is submitted revised
als Wah Each film Dy.No.2356 Medicines and under review Form-5 with
Cantt, coated tablet Rs.8000/= Health and for the uncoated tablet
Rawalpindi contains Rs.12,000/ Products submission of composition.
Cinitapride 06-04-2015 commitments
…..…..1mg 1x10’s Cinita Tablet as per decision The firm has
(Gastroprokin As Per SRO 1mg of GETZ of 251st clarified the salt
etic Agent). Pharma Registration form of API as acid
Manufacturer’ Board meeting. tartrate.
s specs 8-6-2017: GMP (M-268).
certificate Fee for change of
granted by the Deferred for formulation.
panel the following
submission:
(M-277)
 Change in
formulation
to uncoated
tablet as per
the reference
product in
Spain.
 Fee for change
of
formulation.
 Clarification
of salt form of
API of the
product since
rd th
the reference
product
contains
Cinitapride as
acid tartarate.

a. New DML
Evaluator PEC-VII
Case. No.. 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.

1 Tablet (General) Section 17 10
2 Capsule (General) Section 21 10
3 Dry Powder Suspension (General) 1 08

Section (11 Previously
approved)
85. Name and address of Manufacturer / M/s Relizon Pharmaceuticals Plot No. 118, Sunder
Applicant Industrial Estate, Lahore
Brand Name+DosageForm+Strength Relizid 100mg/5ml Dry Powder Suspension
Composition Each 5 ml after reconstitution contains:
Linezolid…100mg
Diary No. Date of R&I & fee Duplicate; 23-02-2017; Rs.20,000/-
Pharmacological Group Oxazolidinone Antibiotic
Type of Form Form 5
Pack Size & Demanded Price 60ml / As per SRO
Approval status of product in Reference Linezolid powder for Suspension 100mg/5ml by M/s
Regulatory Authorities West- ward Pharms Int., (USFDA Approved)
Me-too status Barizold Dry Suspension 100 mg/ 5ml by Barrett
Hodgson (Reg#076343)
GMP status New DML granted Inspection Date 05/12/2017
b. New/Additional section(s)
Case. No. 1: M/s Valor Pharmaceuticals, 124/Am Kahuta Triangle, Industrial Area Islamabad. (New Section)
CLB in its 262nd meeting held on 23rd May, 2018 has considered and approved the grant of following one (01)
additional sections of M/s Valor Pharmaceuticals, 124/Am Kahuta Triangle, Industrial Area Islamabad.
“Soft gelatin capsule section”
Accordingly Secretary Central Licensing Board has issued letter for “Grant of Additional Section” dated 25-06-2018.
Soft gelatin capsule section (10 products/5 molecules)
86. Name and address of manufacturer / M/s Valor Pharmaceuticals.
Applicant 124/A Industrial Triangle, Kahuta Road Islamabad
Brand Name +Dosage Form + Strength Evilar 200mg Soft Gel Capsule
Composition Each Soft Gel Capsule Contains:
Alpha tocopheryl acetate ..…200mg
Diary No. Date of R& I & fee Dy.No 19248 dated 28-05-2018 Rs.20,000/- Dated 25-05-2018
Type of Form Form-5
Pack size & Demanded Price 100’s; Rs. 312/-
Approved in Germany
Me-too status Zescap 200mg capsule Of M/s Zafa Pharmaceutical Laboratories
(Pvt) Ltd. (Reg.#030625)
GMP status New section granted on 25-06-2018
Type of Form Form-5
Pack size & Demanded Price 100’s; Rs. 720/-
Approval status of product in Not verifiable
(Pvt) Ltd. (Reg.#030627)
meeting.
Type of Form Form-5
Pack size & Demanded Price 100’s; Rs. 528/-As per SRO
Approval status of product in Not verifiable
(Pvt) Ltd. (Reg.#030626)
meeting.
Brand Name +Dosage Form + Strength Isosoft 20mg Soft Gel Capsule
Isotretinoin…20mg
Pharmacological Group Retinoids
Type of Form Form-5
1. Approved in US-FDA
Me-too status Acnewin Capsule 20mg of Wnsfield Pharmaceuticals (Reg.#
064335)
Decision: Approved
Brand Name +Dosage Form + Strength Isosoft 10mg Soft Gel Capsule
Isotretinoin…10mg
Pharmacological Group Retinoids
Type of Form Form-5
2. Approved in US-FDA
Me-too status Acnewin Capsule 10mg of Wnsfield Pharmaceuticals (Reg.#
064334)
Decision: Approved
Brand Name +Dosage Form + Strength Angisoft 10mg Soft Gel Capsule
Nifedipine…10mg
Pharmacological Group Calcium channel blocker
Type of Form Form-5
Pack size & Demanded Price 30’s; Rs. 1207.20/-
Me-too status Nifed soft gelatine capsule of M/s Unimark (Reg.# 021977)
Decision: Approved
Brand Name +Dosage Form + Strength Bonefine 50,000 IU Soft Gel Capsule
Vitamin D3…50,000 IU
Type of Form Form-5
Pack size & Demanded Price 5’s ;Rs. 210/-
12’s; Rs. 345/-
Me-too status Vitamin D3 Softgel Capsules of M/s Mascon Pharmacal, Lahore
(Reg.#059290)
Brand Name +Dosage Form + Strength Cylor 100mg Soft Gel Capsule
Cyclosporine…100mg
Type of Form Form-5
Pack size & Demanded Price 10’s, 2 x 7’s, 3 x 10’s, 5 x 10’s; As per SRO
Me-too status Sandimmun capsules 100mg of M/s Haji Sons Rawalpindi (Reg.#
012176)
Cyclosporine…25mg
Type of Form Form-5
Me-too status Sandimmun capsules 100mg of M/s Haji Sons Rawalpindi (Reg.#
012177)
Cyclosporine…50mg
Type of Form Form-5
Me-too status Sigmasporin Microral 50mg Soft Gelatin Capsule of M/s
Universal Enterprises Karachi (Reg.# 066042)
Case. No. M/s Irza Pharma (Pvt) Ltd.10.2 km Lahore Sheikhupura road, Lahore
CLB in its 254th meeting held on 15th June, 2017 has considered and approved the expansion of additional section/
amendment of firm for following two (02) sections
1. Dry Powder Suspension section (Cephalosporin)
2. Capsule section (Cephalosporin)
Sr.No. Section No. of products No. of molecules

1. Dry Powder Suspension section 10 05
(Cephalosporin)
96. Name and address of Manufacturer / M/s Irza Pharma (Pvt) Ltd.10.2 km Lahore Sheikupura road, PO
Applicant Kot abdul Malik, Distt: Sheikhupura
Brand Name+ Dosage Form+ Strength Lexin Dry suspension 250mg/5ml
Cephalexin (as monohydrate)..…...250mg
Diary No. Date of R&I & fee Dy. No. 21529 ; 19-6-2018; Rs.20,000/- (14-6-2018)
Type of Form Form-5
Pack Size & Demanded Price 60 ml; Rs.102/-
Approval status of product in Reference Cephalexin 250mg/5ml of (USFDA approved)
Me-too status X- Tab 250mg/5ml Dry Powder Suspension of M/s Wellborne
Pharmaceuticals
GMP status New section; Date of inspection: 12-05-2017
Decision: Approved.
Brand Name+ Dosage Form+ Strength Lexin Dry suspension 125mg/ 5ml
Cephalexin (as monohydrate) ..…...125mg
Type of Form Form-5
Pack Size & Demanded Price 60 ml; Rs.61.95/-
Approval status of product in Reference Cephalexin 125mg/5ml of (USFDA approved)
Me-too status X- Tab 125mg/5ml Dry Powder Suspension of M/s Wellborne
Pharmaceuticals
Decision: Approved.
Brand Name+ Dosage Form+ Strength I-Drox Dry suspension 250mg/5ml
Cefadroxil as monohydrate…...250mg
Diary No. Date of R&I & fee Dy No. 21522 ; 19-6-2018; Rs.20,000/- (14-6-2018)
Type of Form Form-5
Approval status of product in Reference Cefadroxil 250mg/5ml of (USFDA approved)
Me-too status Baxef 250mg/5ml Dry Powder Suspension of M/s Baxter Pharma
Decision: Approved.
Brand Name+ Dosage Form+ Strength I-Drox Dry suspension 125 mg/5 ml
Cefadroxil as monohydrate…125mg
Type of Form Form-5
Approval status of product in Reference ORACEFAL powder for oral suspension (ANSM Approved)
Me-too status Evacef Suspension of M/s Highnoon Laboratories
Decision: Approved.
Brand Name+ Dosage Form+ Strength Faclor Dry suspension 250mg/5ml
Composition Each 5ml reconstituted suspension contains:
Cefaclor (as monohydrate) …….250mg
Diary No. Date of R&I & fee Dy. No. 21533;19-6-2018; Rs.20,000/- (14-6-2018)
Type of Form Form-5
Approval status of product in Reference Cefaclor 250mg/5ml Suspension by M/s Strides Pharma UK Ltd
Me-too status Sac-Lor 250mg/5ml Dry Suspension by M/s Semos Pharma
(Reg#081618)
Decision: Approved.
Brand Name+ Dosage Form+ Strength Faclor Dry suspension 125mg/5ml
Composition Each 5ml reconstituted suspension contains:
Cefaclor (as monohydrate) …….125 mg
Type of Form Form-5
Approval status of product in Reference Cefaclor 125mg/5ml Suspension by M/s Strides Pharma UK Ltd
Me-too status Sac-Lor 125mg/5ml Dry Suspension by M/s Semos Pharma
(Reg#081617)
Decision: Approved.
Brand Name+ Dosage Form+ Strength Cefdine Dry suspension 125mg/5ml
Cephradine (as monohydrate)…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
Brand Name+ Dosage Form+ Strength Cefdine Dry suspension 250mg/5ml
Cephradine (as monohydrate)…..250mg
Type of Form Form-5
Regulatory Authorities Pharma UK Ltd (MHRA Approved)
Decision: Approved.
Brand Name+ Dosage Form+ Strength Cefix Dry suspension 200mg/5ml
Composition Each 5ml of reconstituted suspension contains:
Cefixime (as trihydrate)……..200mg
Type of Form Form-5
Approval status of product in Reference Suprax of (USFDA approved)
Me-too status Cefamax DS Suspension by M/s Pulse Pharmaceuticals
Decision: Approved.
Brand Name+ Dosage Form+ Strength Cefix Dry suspension 100mg/5ml
Composition Each 5ml of reconstituted suspension contains:
Cefixime (as trihydrate)……..100mg
Type of Form Form-5
Approval status of product in Reference Approved by US FDA
Me-too status Caricef suspension 100mg/5ml of M/s SAMI Pharmaceuticals
Decision: Approved.
c. Remaining Molecules of NL/NS

Case. No.. M/s Skims Pharmaceuticals, Faisalabad.
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 remaining molecule for consideration
by Drug Registration Board.
Sr. No Section No. of Molecule Applied No. of molecules Remaining

Approved
1 Oral Dry Powder Sachet 04 03 7
(General) Section
Now the firm has applied for the following molecules:
Oral Dry Powder Sachet (General) Section
04 Products/ 04 Molecules
106. Name and Address of Manufacturer / M/s Skims Pharmaceuticals,
Applicant 10-B, Value Addition City Khurrianwala, Faisalabad.
Brand Name + Dosage Form + Strength Skimic sachet 200mg
Diary No. Date of R & I & fee Diary No 9786, 15/03/2018, Rs. 20,000/-
Acetylcysteine…200mg.
Pharmacological Group Mucolytic
Type of Form Form-5
Finished Product Specification Innovator's specifications
Approval Status of Product in Reference Acetylcysteine 200 mg Powder for Oral Solution by M/s
Regulatory Authorities. NTC S.r.l. (MHRA approved)
Me-too Status Mucolator 200mg powders by M/s Abbott Laboratories.
(Reg# 017693)
Decision: Approved .
Brand Name + Dosage Form + Strength Skigol Sachet
Macrogol 3350……13.125g
Sodium chloride…..0.3507g
Sodium Hydrogen carbonate……0.1785g
Potassium Chloride……0.0466 g
Pharmacological Group Dy. No.9787; 15-03-2018; Rs.20,000/-
Type of Form Osmotically acting Laxative
Finished Product Specification Form-5
Pack Size & Demanded Price Manufaturer’s Specification
Approval Status of Product in Reference 10’s, As per SRO
Me-too Status Movicol 13.8g sachet, powder for oral solution by M/s
Norgine Limited (MHRA Approved)
GMP Status Marfinal Sachet 13.8g by M/s Martin Dow (Reg#080647)
Remarks of the Evaluator. 19-01-2018
Decision: Approved.
Brand Name + Dosage Form + Strength Skilyte Sachet
Pre-cooked rice…6 g
Sodium chloride…0.350 g
Potassium chloride…0.300 g
Sodium citrate…0.580 g
Pharmacological Group Electrolytes Replenisher
Type of Form Form 5
Pack Size & Demanded Price 10’s
As per SRO
Approval Status of Product in Reference Dioralyte Relief Blackcurrant Sachets by M/s Aventis
Regulatory Authorities. Pharma Limited (MHRA Approved)
Me-too Status Peditral-R sachet by M/s Searle (Reg#076282)
Decision: Approved.
Brand Name + Dosage Form + Strength Skinita Sachet 2g
Composition Each Sachet contains
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 M/s
Regulatory Authorities. Rivopharm UK Ltd. (MHRA approved)
Me-too Status Onita 2g powder by M/s PharmEvo. (Reg# 057746)
Decision: Approved
d. Deferred cases Human
110. Name and address of manufacturer / M/s Liven Pharmaceuticals (Pvt.) Limited, 49-Km Lahore
Applicant Multan Road.
Brand Name +Dosage Form + Strength Civoxin 200mg/100ml infusion
Ciprofloxacin (as hydrochloride)……………….2mg
Pharmacological Group Fluoroquinolone antibiotic
Type of Form Form-5
Approval status of product in Reference -
Me-too status (with strength and dosage Ciplet 200mg/100ml Infusion of M/s Indus pharma
form)
GMP status New DML
Remarks of the Evaluator The firm has applied for Ciprofloxacin (as hydrochloride)
2mg/ml while the reference product approved in MHRA is
approved as 2mg/ml Ciprofloxacin as lactate. Now the firm has
revised its formulation as per innovator.
Each ml contains:
Ciprofloxacin (as lactate)……………….2mg
Previous Decision: The registration Board in its 282nd meeting deferred the product
for submission of fee for revised formulation.
Evaluation by PEC: Firm has now submitted fee of Rs.20,000/- vide original challan
No. 0782503, dated: 31-05-2018.
Decision: Approved.
111. Name and address of manufacturer / M/s MedPharm Research Lab.
Applicant 28-Km, Ferozepur Road, Lahore
Brand Name +Dosage Form + Strength Parmazolin Dry Powder Injection 250mg
Cefazolin (as sodium)…250mg
Type of Form Form-5
Me-too status Cefamezin 250mg injection by M/s Barrett Hodgson
(Reg#008126)
Grant of new DML,
Remarks of the Evaluator. ● Approval status of product in Reference Regulatory
Decision: 281 meeting of registration board held on 11th to 13th
st
April, 2018.
Deferred for evidence of approval of applied formulation in
reference regulatory authorities/ agencies which were
meeting.
Evaluation of PEC Firm has submitted reply:
Approval status of product in Reference Regulatory
Authorities.
 ANCEF cefazolin for injection 250mg by M/s
GlaxoSmithKline (USFDA Approved)
 Applied formulation is discontinued if USFDA
 **Federal Register determination that product was
not discontinued or withdrawn for safety or efficacy
reasons**
Decision: Approved.
Brand Name +Dosage Form + Strength Cipmed Tablet 100mg
Ciprofloxacin (as hydrochloride)…100mg
Pharmacological Group Fluoroquinolone Antibiotic.
Type of Form Form 5
Pack size & Demanded Price 10’s/ As per SRO
Approval status of product in Reference Ciprofloxacin 100 mg film-coated tablets by M/s Cipla (EU)
Me-too status Not confirmed
Grant of new DML,
Remarks of the Evaluator. ● Me-too status not confirmed from available database.
Decision: 281st meeting of registration board held on 11th to 13th April,
2018.
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 along with differential fee.
Me-too status:
Ciproxin Tablet 100mg by M/s Bayer (Reg019879)
Decision: Approved.
Brand Name +Dosage Form + Strength Mednir Dry Suspension 125mg /5ml
Cefdinir …125mg
Type of Form Form-5
Pack size & Demanded Price 60ml /As per SRO
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)
GMP status 12-01-2018. Grant of new DML,
Firm applied as Cefdinir (as monohydrate) but approved
formulation in USFDA contains Cefdinir as base.
rd
710
Decision: 281st meeting of registration board held on 11th to 13th
April, 2018.
Deferred for submission of fee for revision of formulation.
Revision of formulation from Cefdinir (as monohydrate) to
Cefdinir as base.
Firm submitted fee of Rs. 5000/- (Challan 0783233)
Decision: Approved.
Brand Name +Dosage Form + Strength Mednir DS Dry Suspension 250mg /5ml
Cefdinir (as monohydrate) …250mg
Type of Form Form-5
Pack size & Demanded Price 60ml /As per SRO
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 USFDA contains Cefdinir as base.
Decision: 281 meeting of registration board held on 11th to 13th
st
April, 2018.
Revision of formulation from Cefdinir (as monohydrate) to
Cefdinir as base.
Decision: Approved.
Brand Name +Dosage Form + Strength Meddin DS Dry Suspension 250mg /5ml
Cephradine …250mg
Type of Form Form-5
Pack size & Demanded Price 60ml/As per SRO
Regulatory Authorities. Pharma UK Ltd (MHRA Approved)
Grant of new DML,
Remarks of the Evaluator. ● Firm applied as Cephradine (as monohydrate) but
approved formulation in MHRA contains Cephradine as
base.
Decision: 281st meeting of registration board held on 11th to 13th
April, 2018.
Revision of formulation from Cephradine (as monohydrate)
to Cephradine as base.
Decision: Approved.

a. Deferred
116. Name and address of manufacturer / M/s. ICI Pakistan Limited, Life Sciences, 45-Km, off Multan
Brand Name +Dosage Form + Strength DOX-TYL PLUS Powder
Composition Each 100gm contains: -
Tylosin tartarte……..….20gm.
Doxycycline Hyclate…….…40gm.
Colistin sulphate………50MIU
Bromhexine HCl……..…20gm.
Pharmacological Group Antibiotic/antibacterial
Type of Form Form-5
Pack size & Demanded Price 100gm, 250gm, 500gm, 1Kg, 5Kg, 25Kg; Decontrolled
Me-too status Brocotyd Powder of Univet Pharma (Reg#058962)
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.
approved by DRAP (generic / me-too status) alongwith
registration number, brand name and name of firm. (M-279)
of Rs. 20,000/- (Deposit slip # 0754062) dated 15-05-2018
correcting the strength of colistin sulphate and Bromhexine
and me-too reference has been verified
Each 100gm contains: -
Tylosin tartarte……..….20gm.
Doxycycline Hyclate…….…40gm.
Colistine sulphate………10gm
Bromhexine HCl……..…2gm.
Brand Name +Dosage Form + Strength DIURETIC POWDER
Composition Each Kg contains:-
Methenamine…………………950gm.
Vitamin B1…………………...4gm.
Vitamin B2………………….3gm.
Vitamin B6………………….4gm
Calcium d-penthothenate……..3gm
Nicotinamide…………….3gm
Pharmacological Group Diuretic / vitamin
Type of Form Form-5
Pack size & Demanded Price 100gm, 250gm, 500gm, 1Kg, 5Kg, 25Kg; Decontrolled
Me-too status FLUSHMONT WSP of Westmont (Reg#048190)
cGMP.
Remarks of the Evaluator.  The submitted me-too reference is of different strength.
 Clarification of pharmacological group is required since you
have mentioned “diuretic”. However, methenamine in
applied formulation is urinary anti-infective medicine.
after removal of Vitamin B1 and Vitamin B2 and me-too
reference has been verified.
Each gm contains:-
Methenamine…………………955mg
Vitamin B2………………….10mg
Calcium d-pentothenate……..5mg
Nicotinamide…………….25mg
Decision: Registration Board deferred the case for consideration on its turn and correction of
pharmacological group.
Brand Name +Dosage Form + Strength DEKA WSP
Composition Each Kg contains:-
Vitamin A………………………..…..55MIU
Vitamin D3……………………..…..10MIU
Vitamin E……………………..……..30,000IU
Vitamin K3……………………..……..22,000mg
Vitamin C…………………………….50,000mg
Type of Form Form-5
Pack size & Demanded Price HDPE plastic Jar 100gm, 250gm, 500gm & 1Kg;
HDPE plastic Bucket 5Kg & 25Kg;
Decontrolled
Me-too status ADEKON PLUS powder of Lexicon pharma (Reg#043268)
cGMP.
Remarks of the Evaluator.  Reference of already approved formulation with
DRAP/DCO is required to be submitted.
revising the strength of the formulation and me-too reference
has been verified.
Each Kg contains:-
Vitamin A………………………..…..20MIU
Vitamin D3……………………..…..2MIU
Vitamin E……………………..……..6000mg
Vitamin K3……………………..……..5,000mg
Vitamin C…………………………….70gm
Brand Name +Dosage Form + Strength MINERAL SUPPLEMENT LIQUID

Calcium (as calcium Gluconate)…………3.5gm
Phosphorous (as Tri-Calcium)………..…1.75gm
Chelated Zinc (as Zinc Sulphate)………0.10gm
Chelated Chromium…………………..…4gm
(as Chromium Chloride Hexahydrate)
Vitamin D3……………………….……1500 IU
Vitamin B12………………………..…..200mg
Pharmacological Group Vitamin/Mineral Supplement
Type of Form Form-5
Pack size & Demanded Price 10ml, 50ml, 100ml; Decontrolled
Me-too status Not provided by the firm
cGMP.
has been verified.
Each ml contains:-
Calcium chloride hexahydrate……………2mg
Magnesium chloride hexahydrate ………..…4mg
Potassium chloride……………………….…8 mg
Sodium chloride……………………………120mg
Cyanocobalamin………………………..…..0.025mg
Sodium lactate……………………………..42.7mg
Decision: Registration Board deferred the case for consideration on its turn.
Brand Name +Dosage Form + Strength VITA-C Oral Solution
Vitamin C…………………150mg
Type of Form Form-5
Pack size & Demanded Price 100ml, 500ml, 1000ml; Decontrolled
Me-too status V.C Liquid of Leads Pharma (Reg # 063719)
cGMP.
has been verified.
Each ml contains:
Vitamin C…………………250mg
Case No. 04: Registration applications of categories to be considered on priority
Export Facilitation: Application was received through letter No.F.6-2/2016-Reg-III(Vol-I), The firm
claimed 3 molecules to be considered on priority”.
121. Name and address of manufacturer / M/s Focus & Rulz Pharmaceuticals Pvt Ltd Islamabad
Applicant
Brand Name +Dosage Form + Strength Sanata tablet 1mg
Cinitapride(as acid tartarate)……1mg
Type of Form Form-5
Approval status of product in Reference Approved in Spanish Agency of Medicines and Health
Regulatory Authorities. Products
Me-too status Cinic tablet of Fynk Pharma (Reg # 074446)
GMP status 25-1-2018 Firm was considered to be operating at Fair
compliance with GMP Guidelines.
Applicant
Brand Name +Dosage Form + Strength Amsart tablets
Amlodipine besylate eq to Amlodipine….10mg
Valsartan….160mg
Diary No. Date of R& I & fee Dy. No.21076, 12-6-2018; Rs.20,000/- (12-6-2018)
Pharmacological Group Antihyertensive
Type of Form Form-5
Pack size & Demanded Price 7’s, 14’s, 28’s, 30’s, 56’s, 90’s, 98’s, As per SRO
Approval status of product in Reference Exforge tablet 10mg/160mg of M/s Novartis
Regulatory Authorities. Pharmaceuticals (USFDA Approved)
Me-too status Exforge tablet 10mg/160mg of M/s Novartis Pharma,
Pak (Reg. # 047571)
Decision: Approved
Applicant
Amlodipine besylate eq to Amlodipine….5mg
Valsartan….80mg
Type of Form Form-5
Approval status of product in Reference Exforge 5/80mg tablet of M/s Novartis Pharma (UK)
Regulatory Authorities. Limited (emc-MHRA Approved)
Me-too status Exforge 5/80mg tablet of M/s Novartis Pharma (Pak)
Limited
Decision: Approved
Applicant
Amlodipine besylate eq to Amlodipine…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
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Pantazole 40mg tablet
Pantoprazole sodium….40mg
Type of Form Form-5
Approval status of product in Reference Pantoprazole 40mg Delayed release tablet USFDA
Regulatory Authorities. Approved
Me-too status Cantrofast Tablets 40mg of Candid Pharmaceuticals
Remarks of the Evaluator. Approved as (Pantoprazole sodium eq to
Pantoprazole…20mg )Delayed release tablet in Reference
Regulatory Authority.
Decision: Deferred for clarification of formulation, since the reference produt contains
pantoprazole sodium equivalent to pantoprazole 40mg, along with applicable fee for revision of
formulation.
Applicant
Brand Name +Dosage Form + Strength Pantazole 20mg tablet
Pantoprazole sodium….20mg
Type of Form Form-5
Approval status of product in ReferenceProtonix 20mg Delayed Release Tablet by M/s Wyeth
Regulatory Authorities. Pharms INC, approved by USFDA
Me-too status Pantocare DR 20mg Tablet by M/s Aims
Pharmaceuticals
Remarks of the Evaluator. Approved as (Pantoprazole sodium eq to
Pantoprazole…20mg )Delayed release tablet in Reference
Regulatory Authority.
Decision: Decision: Deferred for clarification of formulation, since the reference produt
contains pantoprazole sodium equivalent to pantoprazole 20mg, along with applicable fee for
revision of formulation.
R-II vide its letter No.F.7-7/2017-reg-II (Vol-I) dated 28th June, 2017 requested PEC to take up these
Registration applications on priority basis in Lieu of Export Facilitation.
127. Name and address of Manufacturer / S.J. & G Fazul Elahie (Pvt.) Ltd.E-46 S.I.T.E., Karachi.
Applicant
Brand Name +Dosage Form +Strength Water For Injection
Sterile Water For Injection…10ml
Pharmacological Group Diluent/Solvent
Type of Form Form-5
Finished Product Specification European Pharmacopoeial Specifications
Pack Size & Demanded Price 1’s,(10ml); As per SRO
Me-too status Water for injection 10ml by M/s Novamed
(Reg#076972)
GMP status GMP inspection conducted on 2nd May 2018 with conclusive remarks
that panel was satisfied with the improvement undertaken by the firm.
Decision: Approved with USP specifications.

128. Name and address of Manufacturer / S.J. & G Fazul Elahie (Pvt.) Ltd.E-46 S.I.T.E., Karachi.
Applicant
Brand Name +Dosage Form +Strength Water For Injection
Sterile Water For Injection…2ml
Pharmacological Group Diluent/Solvent
Type of Form Form-5
Finished Product Specification European Pharmacopoeial Specifications
Pack Size & Demanded Price 1’s,(2ml); As per SRO
Me-too status Water for injection 2ml of Healthtek
GMP status GMP inspection conducted on 2nd May 2018 with conclusive remarks
that panel was satisfied with the improvement undertaken by the firm.
Decision: Approved with USP specifications.

Following files were received from Registration-V section vide letter no. F.8-6/2013-Reg-V, dated 20-06-2018,
stating as under:
“The firm claimed four (04) molecules to be considered on priority against USD 460,304 duly verified form
submitted documents (Form E GD form and shipment/invoices) as per decision of Registration Board.
129. Name and address of manufacturer / M/s English Pharmaceuticals Industries. Link Kattar Bund
Applicant Road, Thokar Niaz Baig, Multan Road, Lahore
Brand Name +Dosage Form + Strength Trigec 50mg/Vial Infusion
Tigecycline…50mg
2018
Type of Form Form-5
Me-too status Tygacil Injection by M/s Wyeth Pakistan Limited,Karachi
(Reg.#045642)
GMP status Copy of cGMP certificate valid upto 15-01-2019, issued by
Additional Director, DRAP, Lahore
Remarks of the Evaluator. Firm has applied a second application for the same
formulation as per following details:
Dy. No: 20579 dated 07-06-2018
Fee: Rs. 20,000/- vide deposit slip no. 0767696 dated 07-06-
2018
Decision: Approved. Registration Board declared the second application of the firm, detailed as
under, of the same formulation as disposed off.
“Dy. No: 20579 dated 07-06-2018
Fee: Rs. 20,000/- vide deposit slip no. 0767696 dated 07-06-2018”
Brand Name +Dosage Form + Strength Coliate IV Injection
Colistimethate Sodium…1MIU
2018
Type of Form Form-5
Me-too status Colistat powder for Injection of M/s Medisure Lab. Karachi
(Reg.# 076160)
Decision: Approved
Brand Name +Dosage Form + Strength Engsunate 30mg Injection
Artesunate …30mg
Diary No. Date of R& I & fee Dy.No 23645 dated 11-12-2017 Rs. 20000 Dated 11-12-2017
rd
719
Type of Form Form-5
Approval status of product in Reference WHO prequalified formulation
Me-too status Gen-M Injection by M/s Genix Pharma Karachi
(Reg#076072)
Decision: Approved
Artesunate …60mg
Type of Form Form-5
Me-too status Misonate 60mg Injection by M/s Tabros Pharma (Pvt) Ltd.
Karachi (Reg#057719)
Decision: Approved
Artesunate …120mg
Type of Form Form-5
Me-too status Gen-M Injection by M/s Genix Pharma Karachi
(Reg#076073)
Decision: Approved
Brand Name +Dosage Form + Strength Feribox Injection
Composition Each ml Contains:
Iron as Ferric Carboxymaltose……50mg
Pharmacological Group Antianemic preparation
Type of Form Form-5
Pack size & Demanded Price 2ml, 10ml, 20ml vial: As per SRO
Me-too status Ferinject Injectable 10ml vial of M/s M/s. RG Pharmaceutica
(Pvt.) Ltd., (Reg.# 072548)
Remarks of the Evaluator.  Firm has applied for multiple volumes against one
registration application
Decision: Registration Board approved the application with a fill volume of 10ml only.
Brand Name +Dosage Form + Strength Engusnate 50mg tablet
Artesunate……50mg
Diary No. Date of R& I & fee Dy.23643 dated 11-12-2017 Rs.20,000/- Dated 11-12-2017
Type of Form Form-5
Me-too status Artesunate tablets of M/s Hilton Pharma Karachi
(Reg.#015530)
Decision: Approved
b. Local manufacturing applications of priority categories defined by Registration Board

in its 257th meeting
136. Name and address of manufacturer / M/s Trigon Pharmaceuticals Pvt. Ltd., 8-Km Thoker Raiwind
Brand Name +Dosage Form + Strength Tri-Vir 0.5mg tablet
Entecavir……………........0.5mg
Type of Form Form-5
Pack size & Demanded Price 3x10’s; Rs.10,000/-
Me-too status (with strength and dosage Envir 0.5mg tablet of M/s Highnoon Laboratories
form)
GMP status Firm is GMP compliant as per inspection report dated 14-2-
2018.
Decision: Deferred for confirmation of valid DML status of the firm.
c. Import applications of priority categories defined by Registration Board in its
257th meeting
137. Name and address of Applicant M/s Helix Pharma (Pvt.) Ltd.
Hakimsons House, A-56, S.I.T.E Manghopir Road, Karachi
Detail of Drug Sale License Address: M/s Helix Pharma (Pvt.) Ltd.
Status: Drug sale license by the way of wholesale
Name and address of M/s Reliance Life Sciences Pvt. Ltd.
manufacturer Plant 6, Dhirabhai Ambani Life Science Center DALC
R-282, TTC Area of MIDC ,Thane-Belapur Road, Rabale,
Navi Mumbai, Maharastra, India
Name and address of marketing M/s Reliance Life Sciences Pvt. Ltd.
authorization holder Plant 6, Dhirabhai Ambani Life Science Center DALC
Brand Name +Dosage Form + Relidomide Capsule 5mg
Strength
Lenalidomide…….. 5mg
Shelf life 2 years
Demanded Price As per PRC
Pack size 7’s, 10’s, 21’s
International availability REVLIMID [lenalidomide] capsules
USFDA Approved
Me-too status N/A
Detail of certificates attached  Original legalized CoPP (certificate No.
COPP/CERT/KD/60872/2017/11/20669/104194) certified by
Food and Drug Administration Maharashtara State, Mumbai
400 051 issued on 10/09/2017 confirms the free sale of the
product in exporting country. The facilities and operations
conform to WHO-GMP.
 GMP certificate issued by Food and Drug
Administration M.s Bandra (E), Mumbai, India (Validity 17,
May 2019.
 Copy of letter of authorization
Dated: 28 March 2018
Validity : 5 years
Remarks of the Evaluator.  The firm has claimed In House specifications and the
product is not present in USP/BP.
 Approved with box warning in USFDA.
Decision: Approved as per policy of Inspections of manufacturer abroad.
Strength
Shelf life 2 years
USFDA Approved
Me-too status N/A
conform to WHO-GMP.
May 2019.
Validity : 5 years
Strength
Shelf life 2 years
USFDA Approved
Me-too status N/A
conform to WHO-GMP.
May 2019.
Validity : 5 years
 Approved with box warning in USFDA.
Case No. 05: Registration applications of import cases
140. Name and address of Applicant M/s. Highnoon Laboratories Limited,
17.5 Km, Multan Road, Lahore
Detail of Drug Sale License Address: M/s. Highnoon Laboratories Limited, 17.5Km,
Multan Road, Lahore
Status: Sell drugs as a distributor
Name and address of manufacturer M/s Cipla ltd., L-139 to L-146, Verna Industrial Estate, Verna
Goa.
Name and address of marketing M/s Cipla ltd., L-139 to L-146, Verna Industrial Estate, Verna
authorization holder Goa.
Brand Name +Dosage Form + SEROFLO-250 HFA Inhaler 25mcg/250mcg
Strength CFC Free
Composition Each Actuation delivers:
Salmeterol (as Salmeterol xinafoate)……. 25mcg
Fluticasone propionate…………………... 250mcg
Pharmacological Group Adrenergics in combination with corticosteroids or other drugs,
excl. anticholinergics
Demanded Price As per brand leader
Pack size 1’s, 120 Metered Dose
International availability Seroflo (25mcg/125mcg and 25mcg/250mcg) Inhaler by M/s
Fanin Uk Ltd. (MHRA approved)
Me-too status Saltra Inhaler (25mcg/125mcg and 25mcg/250mcg) by M/s
Getz Pharma (Reg No. 081558)
Detail of certificates attached Legalized Copy CoPP
Certificate No. 721/MFG/WHO-GMP/DFDA/2017/71(5)
Issued by: Food and Drug administration, Government of Goa,
Dhanwantari
Valid till 17/08/2019
Confirms the free sale of the product in exporting country. The
WHO.
Copy Letter of Authorization
Cipla Limited ,Peninsula Business Park, Ganpatrao Kadam
Marg, Lower Parel, Mumbai
&
M/s. Highnoon Laboratories Limited,
17.5Km, Multan Road, Lahore
Dated: 20 May 2015
Validity|: 4 years
Remarks of the Evaluator.  The firm has claimed In House specifications while the product
is present in USP and BP.
 Valid DSL Missing. Firm has applied for renewal.
 Significant changes have been observed in Assay values of
stability testing.
Long term stability studies, (30°-65%RH)
Assay Limits (90-110%)
Batch No. Salmeterol Fluticasone

G12067 18 month 9 month
5.6% 5.1%
G12115 3 Month] --
5%
G12531 24 Month --
5.3%
The assay values of Salmeterol and Fluticasone show a
significant change
Accelerated stability studies

G12067 - 1 month
5.1%
G12115 - --
G12531 2 Month --
5.81%
The firm provided the following justification.

The assay of Seroflo HFA inhaler is determined as “Total can
assay” in which concentration of drug substance in the entire
container is determined analytically with stability indicating
method. Although this test is not directly relevant in term of
performance of inhalation aerosols, it provides assurance of
consistency concerning the manufacture of the drug product (e.g.
formulation, filling, crimping, and sealing).
As this test determines content of active substance per can, a
variability in data is possible due to following factor;
a: The content per can depends upon net fill weight of the product.
The in-proces limit given for net fill weight for this product
during manufacturing is 12-13 g with target fill weight of 12.5g.
Considering the variability of 0.5 g in the fill weight, the
corresponding variation in term of percentage would be 4%.
b) The primary contains closure system for metered dose
inhalation products is can and valve. In the valve down
orientation, there is possibility that a slight amount of the drug
may trap in the valve. Thus the content per can may show some
variability due to such inherent nature of formulation.
c) Leakage of propellant is common phenomenon for MDI
products, As per USP <601, a leakage of about 750mg per year
is acceptable for products with less than 15 g fill weight.
Considering the same, a leakage of about 5% propellant could be
expected. This would in turn have an impact on content per can
which is determined based on actual fill weight. As actual fill
weight would decrease on stability due to propellant leakage, the
quantity of API per can as “mg/can” would show difference
against the initial value.
Based upon the above, a 5% change from the initial value cannot
be considered as “significant change”. Also as per ICH QIE, if
there is a significant change at accelerated condition, the shelf life
would be based upon long term stability data. As all the data is
within stability limits, shelf life of the product is justified.
 Scientific justification/rationale with data and root cause analysis for significant changes
(5% variation) in Assay values of stability testing.
Multan Road, Lahore
Status:
Goa.
Diary No. & Date of R& I Dy. No.274 Dated 25/05/2015 (Duplicate Dossier)
Fee including differential fee Rs. 100,000/- Dated 25/05/2015 (Copy of challan)
Brand Name +Dosage Form + SEROFLO-125 HFA Inhaler 25mcg/125mcg
Strength CFC Free
Pharmacological Group Adrenergics in combination with corticosteroids or other
drugs, excl. anticholinergics
Pack size 1’s
International availability Seroflo (25mcg/125mcg and 25mcg/250mcg) Inhaler by M/s
Fanin Uk Ltd. (MHRA approved)
Me-too status Saltra Inhaler (25mcg/125mcg and 25mcg/250mcg) by M/s
Getz Pharma (Reg No. 081557)
Dhanwantari
WHO.
Remarks of the Evaluator.  The firm has claimed In House specifications while the
product is present in USP and BP.
stability testing.
Long term stability studies, (30°-65%RH)

Assay Limits (90-110%)
G12530 18 Month 18 Month
6% 6.1 %
The assay values of Salmeterol and Fluticasone show a
significant change
Accelerated stability studies

G12530 6 Month --
5.5%

consistency concerning the manufacture of the drug product
(e.g. formulation, filling, crimping, and sealing).
a: The content per can depends upon net fill weight of the
product. The in-proces limit given for net fill weight for this
product during manufacturing is 12-13 g with target fill weight
of 12.5g. Considering the variability of 0.5 g in the fill
weight, the corresponding variation in term of percentage
would be 4%.
Considering the same, a leakage of about 5% propellant could
be expected. This would in turn have an impact on content per
can which is determined based on actual fill weight. As actual
fill weight would decrease on stability due to propellant
leakage, the quantity of API per can as “mg/can” would show
difference against the initial value.
Based upon the above, a 5% change from the initial value

cannot be considered as “significant change”. Also as per ICH
QIE, if there is a significant change at accelerated condition, the
shelf life would be based upon long term stability data. As all
the data is within stability limits, shelf life of the product is
justified.
 Scientific justification/rationale with data and root cause analaysis for significant changes
in Assay values of stability testing.
Multan Road, Lahore
Status:
Goa.
Brand Name +Dosage Form + SEROFLO-50 HFA Inhaler 25mcg/50mcg CFC free
Strength
Pharmacological Group Adrenergics in combination with corticosteroids or other
drugs, excl. anticholinergics
Pack size 1’s
International availability Seretide Evohaler 25 microgram /50 microgram by M/s Glaxo
Wellcome UK Ltd (MHRA Approved)
Me-too status Salmicort inhaler 25mcg/50mcg by M/s Macter Int. (Reg #
045209)
Dhanwantari
WHO.
Remarks of the Evaluator.  The firm has claimed In House specifications while the
product is present in USP and BP.
stability testing. In Long term stability studies, for batch
No.G22699, the assay values of Salmeterol show a
significant change of 7.7% between initial and 18 month time
point.
consistency concerning the manufacture of the drug product
(e.g. formulation, filling, crimping, and sealing).
a: The content per can depends upon net fill weight of the
product. The in-proces limit given for net fill weight for this
product during manufacturing is 12-13 g with target fill weight
of 12.5g. Considering the variability of 0.5 g in the fill
weight, the corresponding variation in term of percentage
would be 4%.
Considering the same, a leakage of about 5% propellant could
be expected. This would in turn have an impact on content per
can which is determined based on actual fill weight. As actual
fill weight would decrease on stability due to propellant
leakage, the quantity of API per can as “mg/can” would show
difference against the initial value.
Based upon the above, a 5% change from the initial value

cannot be considered as “significant change”. Also as per ICH
QIE, if there is a significant change at accelerated condition, the
shelf life would be based upon long term stability data. As all
the data is within stability limits, shelf life of the product is
justified.
 Scientific justification/rationale with data and root cause analaysis for significant changes
in Assay values of stability testing.
143. Name and address of Applicant M/s. Oncogene Pharmaceuticals, Head office 246/B,
PECHS, Block 6, Karachi
Detail of Drug Sale License Applied for Renewal dated:25-01-2018
Name and address of manufacturer M/s. Hangzhou Jiuyuan Gene Engineering Co. Ltd.
No. 23, No. 8th Street, Hangzhou Economic and Technological
Development Zone, Hangzou, Zhejiang, China
Name and address of marketing M/s. Hangzhou Jiuyuan Gene Engineering Co. Ltd.
authorization holder No. 23, No. 8th Street, Hangzhou Economic and Technological
Development Zone, Hangzou, Zhejiang, China
Brand Name +Dosage Form + Oncosetron Injection 0.25mg/5ml
Strength
Palonosetron Hydrochloride eq. to Palonosetron …0.25mg
Pharmacological Group ATC Code: A04AA05, Serotonin (5HT3) antagonists
Demanded Price Rs. 900/Pack
Pack size Ampoule
International availability Sweden Approved(Ampoule)
Me-too status 070580 Arista Injection 0.25mg / 5ml by S.J & G Karachi
.5ml vial
Detail of certificates attached CoPP
Certificate No. 2018-002
Certified by : Hangzhou Market Supervision Administration
Bureau
The facilities and operations conform to GMP as recommended
by WHO.
Free sale certificate No.:2016-016
Validity: July 28, 2018
GMP certificate No. CN20130269
Remarks of the Evaluator. Long term stability data(25°C /60%±10%RH)
Intermediate stability data(30°/70%±10%RH)
(0,3,6,9,12,18,24)
Batches kept on intermediate stability are also different.
Firm has also proposed storage condition below 25°C.
 Submission of fee of Rs. 50.000/- since applied formulation is of me-too status.
 Submission of stability data as per Zone IV A condition i.e. 30°C±2°C/65%±5%RH.
c. Deferred cases Human

144. Name and address of Applicant M/s. Amtul Pharmaceuticals, 251-Sikandar Block
Allama Iqbal Town, Lahore
Name and address of manufacturer M/s REYOUNG PHARMACEUTICAL CO., No.6,
Erlangshan Road, Yiyuan County, Shandong Province,
P.R. China.
Name and address of Marketing M/s REYOUNG PHARMACEUTICAL CO., No.6,
authorization holder Erlangshan Road, Yiyuan County, Shandong Province,
P.R. China.
Brand Name+Dosage Form + Strength Piptaz 4.5 g powder for injection
Piperacillin Sodium……….4.03gm
Tazobactum Sodium ……………… 0.536mg
Finished product Specification Firm has claimed in house specification
Shelf life
Diary No. & Date of R& I Dy. # 966 dated 25-07-2012
Fee including differential fee Rs. 15000/- (25-07-2012) + Rs. 85000/- (29-03-2013)
Pack size one vial

International Availability MHRA approved product of Sandoz
Me-too status Piptazo-Regent
Detail of certificates attached Legalized CoPP dated 02-07-2012.
Decision of 258th Board meeting:  Deferred for evaluation of CoPP (M-258)
Evaluation by PEC The firm has submitted Following embassy attested
documents
1. Free sale issued dated
2. GMP valid upto 17.2.2019
Decision of previous Board meeting: Deferred for the clarification of composition of
formulation on free sales certificate as on free sales only
brand name is mentioned. (M-261)
Deferred for submission of valid original & legalized
CoPP (M-278)
Fresh Evaluation:
Original embassy attested free sale certificate is already available in the dossier
Furthermore, scanned copy of CoPP (issued on 12th May 2016) as per the available record shows the
composition is as follows:
Piperacillin…. 4.0 g (Piperacillin sodium: 4.03g)
Tazobactum… 0.5g (Tazobactam sodium: 0.536 g)
Shelf Life: 3 years
Decision: Approved as per Policy for inspection of Manufacturer abroad. Moroever Registration
Board decided that the firm will provide Original legalized CoPP before issuance of registration
letter.
145. M/s. Revive Health Colicraft 2,000,000 IU Form 5A MHRA. COPP 260th
Care, Office No.503, Lypholized powder for Dy No.358 Colomyci was Meeting
5th Floor, 6 Main solution for Injection R&I dated n 1MIU & issued by Registration
Gulberg, Jail Road, Each vial contains:- 29-04- 2 MIU by Spain on Board held
Lahore. Colistimethate Sodium 2016 M/s dated 04- on 28-29th
M/s. GENFARMA …2,000,000 I.U Rs.50,000/ Forest. 05-2016. June, 2016
LABORATORIO, S.L. (Antibiotic)/Polymyxi - GMP Deferred for
Site address Avda. De n ) As per complian confirmation
la Constitucion, 198- USP Specifications PRC. t as per whether
199, Poligono 03 years COPP formulation
Industrial Monte Boyal, dated 04- is me too or
Casarrubios del Monte 05-2016. otherwise
45950 (Toledo)
Espana, Spain.
Evaluation by PEC
Firm has stated that the applied product is a new molecule, not approved/registered by the board for sale
in Pakistan.
Deferred for confirmation of me-too status from registration section and clarification regarding
importability from India as per Import Policy Order.
Fresh evaluation by PEC:
Firm has submitted that the manufacturer of the product is from Spain and the product is not imported
from India. Furthermore firm has submitted that it is a new drug and not previously registered or approved
by Registration Board.
146. Name and address of Applicant M/s Chiesi Pharmaceuticals Pvt. Limited 60/1A, XX, Phase III,
Commercial Zone, Khayaban-e-Iqbal , DHA Lahore
Detail of Drug Sale License Address: 60/1A, XX, Phase III, Commercial Zone, Khayaban-
e-Iqbal , DHA Lahore
Store: Khewat 55 14 Km Multan Road, Near Thokar Niaz Biag
Validity: 25 July 2019
Name and address of manufacturer M/s Chiesi Farmaceutica S.p.A
Via San Leonardo 96
43122 Parma, Italy
Name and address of marketing M/s Chiesi Farmaceutica S.p.A
authorization holder Via Palermo 26/A
43122 Parma, Italy
Diary No. & Date of R& I 25374, 20-12-17
Brand Name +Dosage Form + Strength Trimbow Inhaler
Pressurized Metered Dose Inhaler
Composition Each metered dose contains:
Beclomethasone Dipropionate…100ug
Formoterol fumarate dihydrate….6ug
Glycopyrronium bromide ……12.5ug
eq to Glycopyrronium 10ug
Pharmacological Group Inhaled Corticosteroid, Long Acting Beta2 agonist,
Antimuscarinic
Shelf life 60 Actuations: 17 months
120 and 180 actuations: 20 months
Demanded Price 60 Actuations: 7227.00 Rs.
120 Actuations: 12045.80 Rs.
180 actuations: 18067.00 Rs.
Pack size 1 container of 60, 120 and 180 actuations
Multiple packs 2 or 3 containers 120 actuations each.
International availability Italy Approved
Me-too status ---
Detail of certificates attached ● Original Legalized CoPP
Certificate No: 02/17/114925
Certifying Authority: EMA
● GMP: The facilities and operations of Manufacturing site
conform to GMP as recommended by WHO.
● GMP Certificate
Certificate no. IT/112-7/H/2017
Manufacturer Address: M/s Chiesi Farmaceutica S.p.A
Via San Leonardo 96-43122 Parma
Certified by: Issued by AIFA
Inspection Date: 02-01-2017
Validity: 3 years
Remarks of the Evaluator. ● Stability of 2 batches have been provided for container with
180 actuations.
● No 3rd batch is available firm has submitted reply.
Previous Meeting Decision(M-282):
Deferred for the following reasons:
● Submission of stability data of at least three batches for 180 actuations as provided data is of 2
batches.
● Submission of stability data of atleast 3 batches 120 actuations supporting the shelf life of 20
months.
● Submission of stability data of atleast 3 batches of 60 actuations supporting the shelf life of 17
months.
● Submission of separate application in for each pack size (no. of actuations) of applied formulation
since shelf life of every pack size is different.
Evaluation by PEC
Firm has not conducted all tests at final timepoint i.e 24 month.
Decision: Registration Board deferred for submission of complete stability studies analysis at final
time point.
147. Name and address of Applicant M/s Ali Gohar & Company.
State life Building 1-B, I.I.Chundrigar Road, Karachi
Detail of Drug Sale License Address: Ali Gohar Company (PVT) Ltd authorized agent
of M/s Alcon Pharmaceuticals Limited, B-23 Site Karachi
Status: Drug license by the way of wholesale
Name and address of manufacturer M/s Boehringer Ingelheim Pharma GmbH & Co. KG Binger
Production site: Biberach Birkendorfer Strasse 65 88397
Biberach/Rib, Germany
Name and address of marketing M/s Boehringer Ingelheim Pharma GmbH & Co. KG Binger
authorization holder Strasse 173 55216 Ingelheim am Rhein, Germany
Brand Name +Dosage Form + Strength Actilyse injection 20mg
Powder for solution for IV injection/infusion
Alteplase…….. 20mg
Pharmacological Group Antithrombotic Agent
Shelf life 3 years
Demanded Price To be communicated
Pack size 1’s Vial
International availability Germany approved
Me-too status N/A
Certificate No. 247/17
Certified by: Landesamt fur Soziales, Jugend und
ersorgung-Zweigtelle Landau, Germany
Issued on: 17/05/2017
Free sale in exporting: Confirms the free sale of the product
in exporting country.
GMP: The facilities and operations conform to GMP as
Alteplase is an enzyme produced by recombinant DNA technology.
The following are the shortcomings communicated to the firm;
 Credentials of manufacturer.
 Label specimen as per The Drugs (labeling and Packaging) Rules 1986.
The firm submitted the following reply:
• As per the practice in vogue the credentials of manufacturer are required only for new
manufacturer where as the products from Boehringer Ingelheim Pharma GmbH and Co. KG are already
registered with DRAP. In the previous board meeting our product Jardiance was approved from the Drug
registration board from the same manufacturer. We are sure that considering this practice you may oblige
us by dropping this requirement.
• Actilyse injection 20 mg and Actilyse injection 50mg (Powder for solution for IV
injection/infusion) is a hospital only product to be administered by qualified physician only and printing
of Urdu information may jeopardize the safety of patient as it may lead to use by non professionals. It is
therefore requested that an exemption from Urdu version may please be granted in best interest of patients.
Observations on Stability Data
 Stability testing done at 30°C and 70%RH. Moreover testing at 9 month has not been performed.
 Stability testing done at 40°C and 75%RH on only 2 batches.
Previous Decision(M-279):
Deferred for following:
 Clarification whether applied formulation is of synthetic origin or biological origin.
 Submission of credentials of manufacturer of the applied product.
 For further deliberation upon firm’s request for exemption from Urdu version of label specimen.
 Clarification of storage conditions for real time stability studies as 30°C and 70%RH does not
correspond with Zone IV-a & Zone IV-b conditions.
 Submission of accelerated stability studies data of three batches.
Evaluation by PEC:
Firm submitted to transfer the dossiers of Actilyse 20 mg powder and solvent to the Biological division
for further action considering the facts mentioned below.
• Actilyse (alteplase) is a biological product. It is a recombinant deoxynucleic acid (DNA)-derived
version of a naturally occurring tissue plasminogen activator (rt-PA) which is normally secreted by human
endothelial cells.
• It is a purified glycoprotein consisting of 527 amino acids and the enzymatic activity of a serine
protease with the property of fibrin-enhanced conversion of plasminogen to plasmin.
• Alteplase is synthesized using the complementary DNA for natural human tissue plasminogen
activator derived from a human melanoma cell line, which has been genetically inserted into an
established mammalian cell line (Chinese Hamster ovary cells.)
Decision: Registration Board referred the case to Biological Division.
Production site: Biberach Birkendorfer Strasse 65 88397
Name and address of marketing M/s Boehringer Ingelheim Pharma GmbH & Co. KG Binger
authorization holder Strasse 173 55216 Ingelheim am Rhein, Germany
Brand Name +Dosage Form + Strength ACTILYSE injection 50mg
Powder for solution for IV injection/infusion
Alteplase…….. 50mg
Pharmacological Group Antithrombotic Agents
Shelf life 3 years
Demanded Price Not proposed
Pack size 2’s
International availability Germany Approved
Me-too status N/A
Certificate No. 246/17
certified by: Landesamt fur Soziales, Jugend und
Versorgung-Zweigtelle Landau, Germany
Issued on: 17/05/2017
Free sale in Exporting country: Confirms the free sale of
the product in exporting country.
GMP: The facilities and operations conform to GMP as
The following are the shortcomings communicated to the firm;
The firm submitted the following reply:
• As per the practice in vogue the credentials of manufacturer are required only for new
manufacturer where as the products from Boehringer Ingelheim Pharma GmbH and Co. KG are already
registered with DRAP. In the previous board meeting our product Jardiance was approved from the Drug
registration board from the same manufacturer. We are sure that considering this practice you may oblige
us by dropping this requirement.
 • Actilyse injection 20 mg and Actilyse injection 50mg (Powder for solution for IV
injection/infusion) is a hospital only product to be administered by qualified physician only and
printing of Urdu information may jeopardize the safety of patient as it may lead to use by non
professionals. It is therefore requested that an exemption from Urdu version may please be granted in
best interest of patients.
Observations on Stability Data
 Stability testing done at 30°C and 70%RH. Moreover testing at 9 month has not been performed.
 Stability testing done at 40°C and 75%RH on only 2 batches.
Previous Decision(279):
 Clarification whether applied formulation is of synthetic origin or biological origin.
 Clarification of storage conditions for real time stability studies as 30°C and 70%RH does not
correspond with Zone IV-a & Zone IV-b conditions.
 Submission of accelerated stability studies data of three batches.
Evaluation by PEC:
endothelial cells.
Detail of Drug Sale License Address: Ali gohar Company (PVT) Ltd authorized agent of
M/s Alcon Pharmaceuticals Limited, B-23 Site karachi
Strasse 173 55216 Ingelheim am Rhein, Germany
Name and address of marketing M/s Boehringer Ingelheim International GmbH Binger
authorization holder Production site: Biberach Birkendorfer Strasse 65 88397
Brand Name +Dosage Form + Strength Sterile water for injection 50ml for Actilyse 50mg
Composition Each vial contaions:
Sterile water for injection……. 50ml
Finished Product Specification Ph. Eur.
Pharmacological Group -----
Shelf life 3 years
Demanded Price -----
Pack size -----
International availability Available in Germany as per CoPP
Me-too status WATER FOR INJECTION (50ml) of M/S. S.J FAZUL
ELLAHI, KARACHI (Reg.# 020098)
Detail of certificates attached  Original legalized CoPP (certificate No. 246/17) certified
by Landesamt fur Soziales, Jugend und Versorgung-
Zweigtelle Landau, Germany on 17/05/2017 confirms the
free sale of the product in exporting country. The facilities
and operations conform to GMP as recommended by
WHO as per CoPP.
 The firm has claimed In House specifications while the product is not present in USP and Ph. Eur.
 Rs. 50,000/- fee has been submitted, however sterile water for injection is already a registered product,
therefore the differential fee of Rs. 50,000/- shall be submitted.
The firm submitted the following reply;
• The sterile water for injection is provided in the combo pack with both Actilyse injection 20 mg
and Actilyse injection 50mg (Powder for solution for IV injection/infusion) therefore separate labeling is
not required in this particular case. We request for waving this condition for sterile water for injection for
the applied product.
• As per the recent decision of the Drug Registration Board the sterile water for injection does not
require separate registration or fee of submission in the combo pack however we submitted the fee and
form 5 as per previous practice. It is requested that the registration for sterile water for injection may please
be granted as a combo pack as per decision of Drug registration board and obliged.
 Submission of differential fee of Rs.50,000/- for application of Import.
Evaluation by PEC:
endothelial cells.
Strasse 173 55216 Ingelheim am Rhein, Germany
Name and address of marketing M/s Boehringer Ingelheim International GmbH Binger
authorization holder Production site: Biberach Birkendorfer Strasse 65 88397
Brand Name +Dosage Form + Strength Sterile water for injection 20ml for Actilyse 20mg
Composition Each vial contaions:
Sterile water for injection……. 20ml
Finished Product Specification Ph. Eur.
Pharmacological Group -----
Shelf life 3 years
Demanded Price -----
Pack size -----
International availability Available in Germany as per CoPP
Me-too status WATER FOR INJECTION (20ml) of M/SMarion Labs.
(Reg.# 058671)
Detail of certificates attached  Original legalized CoPP (certificate No. 247/17) certified
by Landesamt fur Soziales, Jugend und Versorgung-
Zweigtelle Landau, Germany on 17/05/2017 confirms the
free sale of the product in exporting country. The facilities
and operations conform to GMP as recommended by
WHO as per CoPP.
 The firm has claimed In House specifications while the product is present in USP and Ph. Eur.
 Rs. 50,000/- fee has been submitted, however sterile water for injection is already a registered product,
therefore the differential fee of Rs. 50,000/- shall be submitted.
The firm submitted the following reply;
 The sterile water for injection is provided in the combo pack with both Actilyse injection 20 mg
and Actilyse injection 50mg (Powder for solution for IV injection/infusion) therefore separate
labeling is not required in this particular case. We request for waving this condition for sterile
water for injection for the applied product.
 As per the recent decision of the Drug Registration Board the sterile water for injection does not
require separate registration or fee of submission in the combo pack however we submitted the
fee and form 5 as per previous practice. It is requested that the registration for sterile water for
injection may please be granted as a combo pack as per decision of Drug registration board and
obliged.
Stability data of only one batch provided.
 Submission of differential fee of Rs.50,000/- for application of Import.
Evaluation by PEC:
endothelial cells.
Case No. 06 Registration applications of drugs for which stability study data is required to be
verified
a. Onsite verification of stability data
No. of Manufacturer / (Proprietary Name Initial Diary & Availability / Decision /
Applicant + Dosage Form + Date, Fee Local Remarks
Strength), (including Availability (if any)
Pharmacological Demanded Price / GMP Inspection
Group, Pack size Report Date &
Finished Product Remarks
Specification
151. M/s Welmark Dexo 30mg capsule Form 5-D USFDA The firm has
Pharmaceuticals, Approved claimed
Plot # 122, Block – Each capsule Dairy No. 3950 Manufacturer’s
B, Phase-V, contains: dated 20-4-2016 Specifications.
Industrial Estate, Last GMP
Hattar. Dexlansoprazole dual Rs.30,000,23-5- inspection was
delayed release 2016 conducted on 12-
pellets eq to Rs.20,000 20-4- 07-2017 and the
Dexlansoprazole…… 2016 report concludes
……….……30mg satisfactory
30’s in ALu Alu compliance.
Proton Pump packing
Inhibitor As per SRO

Drug Dexo 30mg capsules
Name of Manufacturer M/s Welmark Pharmaceuticals, Hattar
API Lot No. DLP163T
Real Time: 30°C ± 2°C & 65±5%RH
Real Time: 6 Months
Frequency Accelerated: 1,2,3,4,6,8,12,16,20,24,26(Weeks)
Real Time: 1,2,3,4,6,8,12,16,20,24,26(Weeks)
Batch No. (T-01) (T-02) (T-03)
Batch Size 1765 capsules 1765 capsules 1765 capsules
No. of Batches 03
submitted.
2. Approval of API by regulatory authority of Copy of GMP certificate of M/s Vision Pharmaceuticals valid
country of origin or GMP certificate of API up to 25-01-2019
manufacturer issued by regulatory authority
of country of origin.
3. Protocols followed for conduction of Yes
4. Data of 03 batches will be supported by Yes
sheets etc.
5. Documents confirming import of API etc. API is manufactured by M/s Vision Pharmaceuticals,
Islamabad
6. All provided documents will be attested Yes
(name, sign and stamp) for ensuring
Rules, 1978.
 The firm has provided 6Months Accelerated and 6Months Real Time Stability Data for 03 Batches.
No. of Manufacturer / (Proprietary Name Initial Diary & Availability / Decision /
Applicant + Dosage Form + Date, Fee Local Remarks
Strength), (including Availability (if any)
Pharmacological Demanded Price / GMP Inspection
Group, Pack size Report Date &
Finished Product Remarks
Specification
152. M/s Welmark Dexo 60mg capsule Form 5-D USFDA The firm has
Pharmaceuticals, Approved claimed
Plot # 122, Block – Each capsule Dairy No. 126 dated Manufacturer’s
B, Phase-V, contains: 25-5-2016 Specifications.
Industrial Estate, Last GMP
Hattar. Dexlansoprazole dual Rs.30,000,24-5- inspection was
delayed release 2016 conducted on 12-
pellets eq to Rs.20,000 20-4- 07-2017 and the
Dexlansoprazole…… 2016 report concludes
……….……60mg satisfactory
30’s in ALu Alu compliance.
Proton Pump packing
Inhibitor As per SRO

Drug Dexo 60mg capsules
Name of Manufacturer M/s Welmark Pharmaceuticals, Hattar
API Lot No. DLP163T
Real Time: 30°C ± 2°C & 65±5%RH
Real Time: 6 Months
Frequency Accelerated: 1,2,3,4,6,8,12,16,20,24,26(Weeks)
Real Time: 1,2,3,4,6,8,12,16,20,24,26(Weeks)
Batch No. (T-04) (T-05) (T-06)
Batch Size 1765 capsules 1765 capsules 1765 capsules
No. of Batches 03
submitted.
2. Approval of API by regulatory authority of Copy of GMP certificate of M/s Vision Pharmaceuticals valid
country of origin or GMP certificate of API up to 25-01-2019
manufacturer issued by regulatory authority
of country of origin.
3. Protocols followed for conduction of Yes
4. Data of 03 batches will be supported by Yes
sheets etc.
5. Documents confirming import of API etc. API is manufactured by M/s Vision Pharmaceuticals,
Islamabad
6. All provided documents will be attested Yes
(name, sign and stamp) for ensuring
Rules, 1978.
 The firm has provided 6Months Accelerated and 6Months Real Time Stability Data for 03 Batches.
DEXO Capsule 30mg (Dexlansoprazole 30mg)
DEXO Capsule 60mg (Dexlansoprazole 60mg)
Background:
Registration Board considered the applications of M/s. WelMark Pharmaceuticals Hattar for registration of Dexo
Capsule 30mg & 60mg. Registration Board decided to constitute the following panel for onsite investigation to
confirm genuineness / authenticity of stability data and associated documents, import of API, quality, specification,
test analysis, facilities etc.
1. Dr. Muhammad Usman, Dean, Faculty of Pharmacy, University of Lahore.
2. Dr. Muhammad Fakhruddin Aamir, Add. Director (QA & LT –II), DRAP Islamabad.
3. Hafiz M. Ali Tayyab, Assistant Director, DRAP, Islamabad.
The inspection report is being submitted for your kind perusal.

S.No Question Remarks
1. Do you have documents confirming the import of Locally Purchased (M/s VISION
Dexlansoprazole API? Pharmaceutical Islamabad)
2. What was the rationale behind selecting the GMP compliant and easily availability
particular manufacturer of API?
3. Do you have documents confirming the import of Supplied by M/s Vision pharmaceuticals
Dexlansoprazole reference standard and impurity Islamabad
standards?
4. Do you have certificate of Analysis of the API, Yes, except impurity standards.
reference standards and impurity standards?
5. Do you have any approval of API or GMP certificate Yes
of API manufacturer issued by regulatory authority
of country of origin?
6. Do you use API manufacturer method of testing? Yes
7. Do you have stability studies reports on API? Yes
8. If yes, whether the stability testing has been Not available
performed as per SIM method and degradation
products have been quantified?
9. Do you have method for quantifying the impurities Method for quantification of impurities of
in the API? product was not evident from provided
documents.
10. Do you have some remaining quantities of the API, Yes, except impurity standards.
its reference standard and impurities standards?
11. Have you used pharmaceutical grade excipients? Ready to fill pellets
12. Do you have documents confirming the import of the Ready to fill pellets
used excipients?
13. Do you have test reports and other records on the Ready to fill pellets
excipients used?
14. Do you have written and authorized protocols for the Yes
development of Dexlansoprazole capsules?
15. Have you performed Drug-excipient compatibility Ready to fill pellets
studies?
16. Whether firm has performed comparative dissolution Not Performed
studies?
17. Do you have product development (R&D) section The firm doesn’t possess an independent
R&D section. The management informed that
the production facility is being used for the
purpose.
18. Do you have necessary equipments available in No
product development section for development of
Dexlansoprazole capsules?
19. Are the equipments in product development section N/A
qualified
20. Do you have proper maintenance / calibration /re- N/A
qualification program for the equipment used in PD
section?
21. Do you have qualified staff in product development N/A
section with proper knowledge and training in
product development?
22. Have you manufactured three stability batches for Yes
the stability studies of Dexlansoprazole capsules as
required
23. What were the criteria for fixing the batch size of Yes, criteria was followed in the light of
stability batches? decision of 251st DRB Meeting.
24. Do you have complete record of production of Yes
stability batches?
25. Do you have protocols for stability testing of Yes
stability batches?
26. Do you have developed and validated the method for Yes
testing of stability batches?
27. Do you have method transfer studies in case when Not applicable
the method of testing being used by your firm is
given by any other lab?
28. Do you have documents confirming the qualification Calibration record maintained.
of equipments / instruments being used in the test
and analysis of Dexlansoprazole API and the
finished drug?
29. Do your method of analysis stability indicating? Yes, method validated
30. Do your HPLC software is 21CFR compliant? No, Manual record confirmed
31. Can you show Audit Trail reports on No, Manual record confirmed
Dexlansoprazole testing?
32. Do you have some remaining quantities of Degradation products not available.
degradation products and stability batches? Stability batches available
33. Do you have commitment batches kept on stability Yes
testing?
34 Do you have valid calibration status for the Yes
equipments used in Dexlansoprazole capsules
production in analysis?
35 Do proper and continuous monitoring and control are Manual records maintained.
available for stability chamber?
36 Do related manufacturing area, equipment, personnel Yes
and utilities be rated as GMP compliant?
Conclusion: On the basis of risk based approach the genuineness /authenticity of stability data submitted by the
firm for registration of Dexo 30mg and 60mg capsule is verifiable to satisfactory level.
Decision: Registration Board decided to approve registration of “DEXO Capsule 30mg (Dexlansoprazole
30mg), DEXO Capsule 60mg (Dexlansoprazole 60mg), M/s Welmark Pharmaceuticals, Plot # 122, Block –B,
Phase-V, Industrial Estate, Hattar. 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
Sr. Name & Address of Brand Name Type of Form, International
No. Manufacturer / Applicant (Proprietary Name Initial Diary & Date, Fee Availability / Local
+ Dosage Form + (including differential Availability
Strength), fee),
Composition, Demanded Price / Pack GMP Inspection
Pharmacological size Report Date &
Group, Remarks
Finished Product
Specification
153. M/s Pharm Evo Pvt Ltd, A- Inosita Plus XR Tab Form-5 USFDA Approved.
29, North West Industrial 100/1000 Dy. No: 1033 JANUMET XR
Zone, Light Industrial Zone, Tablet Dated.26-06-2014 By MERCK SHARP
Port Qasim, Karachi. Each extended release Rs.20,000/- (25-06-2014) DOHME
tablet contains: 10’s,14’s,30’s
Sitagliptin phosphate Rs. 1720/10’s Tagipmet XR by M/s
monohydrate eq. to Rs. 2400/14’s Highnoon
Sitagliptin…...100mg Rs. 5150/30’s (Reg.#084651)
Metformin HCI
…….. 1000mg (as
extended release)
Anti diabetic
Remarks:
A letter of shortcomings after evaluation of dossier was written to firm (Letter No. F.1-1/2017/PEC-DRAP
(AD PEC-XI) dated 12-04-2017). The firm responded to the letter and submitted master formulation &
manufacturing method. Now the firm has submitted stability studies data with following statement:
“Please note that the manufacturing method & formulation submitted with shortcoming was tentative. Actual
formulation along with manufacturing method have been submitted along with stability data dated 06-12-
2017.”
Following revised data has been submitted along with stability studies data:
i. Composition per unit dose formula
ii. Manufacturing formula
iii. Manufacturing process
iv. Finished product specification
v. Finished product testing method
vi. In-process Control sheet.
The details of new stability study data are as under:
Drug Inosita Plus XR Tab 100/1000
Name of Manufacturer M/s Pharm Evo Pvt Ltd, Port Qasim, Karachi.
Manufacturer of API Sitagliptin: M/s Zheijiang Tianyu Pharmaceutical Co., Ltd.
Metformin hydrochloride: M/s Smruthi Organics Ltd., Dist. Solapur, India
API Lot No. Sitagliptin: 12300-160701
Metformin hydrochloride: BMET-023/16
Description of Pack
Alu-Alu in bleach board carton with leaflet
Time Period Real time: 6 months
Frequency Accelerated: 0,3,6 (month)
Real Time: 0,3,6 (month)
Batch No. 17PD-2059-02-T 17PD-2060-03-T 17PD-2061-04-T
Date of Initiation 03-01-2017 03-01-2017` 03-2017
No. of Batches 03
No.
1. COA of API Yes
2. Approval of API by regulatory authority of country Sitagliptin: Copy of GMP certificate issued to M/s
of origin or GMP certificate of API manufacturer M/s Zheijiang Tianyu Pharmaceutical Co., Ltd by
issued by regulatory authority of country of origin. Zhejiang Food & Drug Administration, valid upto 12-
09-2018.
Metformin hydrochloride: Copy of GMP certificate
(Certificate No. NEW-WHO-
GMP/CERT/PD/58511/2017/11/20402) issued by
FDA Maharashtra valid upto 09-08-2019. The said
certificate has been verified from following website
link as assessed on 27-12-2017:
https://fdawhogmp.maharashtra.gov.in/(X(1)S(zl1lqfb
a3uq4dtiokiyyw1bc))/Report/RptWHOGMPholders.a
spx
Protocols followed for conduction of stability study
Yes
and details of tests.
4. Documents confirming import of API etc. Sitagliptin: Copy of commercial invoice for
Sitagliptin has been submitted. The said invoice is
attested by ADC, DRAP Karachi.
Metformin hydrochloride: Copy of commercial
invoice for Metformin hydrochloride has been
submitted. The said invoice is attested by ADC, DRAP
Karachi.
5. All provided documents will be attested (name, sign
and stamp) for ensuring authenticity of data / Yes
documents.
6. Commitment to continue real time stability study till
Yes
assigned shelf life of the product.
7. Commitment to follow Drug Specification Rules,
Yes
1978.
 The batch no. of Sitagliptin as mentioned on Stability Study data sheet is different form that mentioned on
submitted COA of Sitagliptin from Supplier.
 Date of initiation mentioned on Stability study data sheet i.e. 03-01-2017 is different from that mentioned on
Stability summary sheets & Raw data sheets i.e. 09-01-2017.
 Since API of Sitagliptin is being incorporated via coating solution so how it is possible to ensure that 100mg
of Sitagliptin has been incorporated in dosage form while using 100% quantity in master formulation.
 The documents of master formulation, manufacturing method do not have any issue/effective date.
 Justification is required since you have used UV method in dissolution testing for Metformin while in Assay
testing you have used HPLC method for same API.
 How it could be justified that the results of dissolution analysis for Metformin as performed by UV method
have not been interfered with the other API i.e. Sitagliptin, present in the same sample aliquot.
 The above observations 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 vide its letter dated 30-03-2018, detailed as under:

1. The batch no. of Sitagliptin as Firm has submitted COA of Sitagliptin from M/s
mentioned on Stability Study data Zheijiang Tianyu Pharmaceutical Co., Ltd. with batch no.
sheet is different from that of 12300-160701. Firm has also inhouse analytical report
mentioned on submitted COA of for said batch no. of API wherein inhouse QC Lot No.
Sitagliptin from Supplier which “16M0300R” has been assigned to API batch number of
raise question on genuineness of batch no. of 12300-160701. Firm has also submitted
submitted data. attested commercial invoice, Form 3 , Form 7 & Airway
bill for said API batch no.
2. Date of initiation of stability studies Date mentioned on stability summary sheet is actually
mentioned in Stability data sheet i.e. sample receiving date from PD for initial testing of
03-01-2017 is different from that Stability batch.
mentioned on Stability summary
sheets & Raw data sheets i.e. 09-01-
2017.
3. Justification of use of 10 % excess 10% overage was used to cover losses during coating since
amount of Sitagliptin in master Sitagliptin is being used in coating. However, finished
formulation tablet has no overage which is provided by Analytical
report of finished product in which assay of Sitagliptin was
well in limit.
4. The documents describing master We would like to inform you that our format of master
formulation, manufacturing method formulation and manufacturing method do not have
do not have any issue/effective date. issue/effective date.
5. Clarification/ Scientific justification We have adapted testing method for Metformin XR tablets
is required since you have used UV from USP as in USP assay of Metformin XR tablet is done
method in dissolution testing for by HPLC and Dissolution testing is carried out by UV
Metformin while in Assay testing spectrophotometer.
you have used HPLC method for
same API.
6. How it could be justified that the We have scanned both API’s on UV spectrophotometer
results of dissolution analysis for and spectrum observed that both API’s shows different
Metformin as performed by UV Lambda max absorbance point i.e. as 232nm for
method have not been interfered Metformin and 266.5 nm for Sitagliptin and also spectrum
with the ingredients of formulation of Inosita Plus XR tablets have been taken and no
specially the other API i.e. interference observed of Sitagliptin.
Sitagliptin, present in the same Firm has submitted UV spectrums for Metformin,
sample aliquot. Sitagliptin and Inosita XR tablet.
It is to be noted that above said spectrums were analyzed
on 01-01-2018 whereas stability study has been initiated
in January 2017.
Strength), fee),
Group, Remarks
Finished Product
Specification
29, North West Industrial 50/1000 Dy. No: 1037 JANUMET XR
Sitagliptin phosphate Rs. 110/tab Tagipmet XR by M/s
monohydrate eq. to Rs. 1100/10’s Highnoon
Sitagliptin…...50mg Rs. 1540/14’s (Reg.#084650)
Metformin HCI Rs. 3300/30’s
…….. 1000mg (as
extended release)
Anti diabetic
Remarks:
2017.”
Description of Pack
No. of Batches 03
No.
1. COA of API
Yes
09-2018.
spx
Protocols followed for conduction of stability study

Yes
Karachi.
documents.
Yes
Yes
1978.
 Justification of use of exactly 10 % excess of Sitagliptin in master formulation.

1. The batch no. of Sitagliptin as Firm has submitted COA of Sitagliptin from M/s
mentioned on Stability Study data Zheijiang Tianyu Pharmaceutical Co., Ltd. with batch no.
sheet is different from that of 12300-160701. Firm has also inhouse analytical report
mentioned on submitted COA of for said batch no. of API wherein inhouse QC Lot No.
Sitagliptin from Supplier which “16M0300R” has been assigned to API batch number of
raise question on genuineness of batch no. of 12300-160701. Firm has also submitted
submitted data. attested commercial invoice, Form 3 , Form 7 & Airway
mentioned in Stability data sheet i.e. sample receiving date from PD for initial testing of
03-01-2017 is different from that Stability batch.
mentioned on Stability summary
sheets & Raw data sheets i.e. 09-01-
2017.
3. Justification of use of 10 % excess 10% overage was used to cover losses during coating since
amount of Sitagliptin in master Sitagliptin is being used in coating. However, finished
formulation tablet has no overage which is provided by Analytical
well in limit.
formulation, manufacturing method formulation and manufacturing method do not have
do not have any issue/effective date. issue/effective date.
5. Clarification/ Scientific justification We have adapted testing method for Metformin XR tablets
is required since you have used UV from USP as in USP assay of Metformin XR tablet is done
method in dissolution testing for by HPLC and Dissolution testing is carried out by UV
Metformin while in Assay testing spectrophotometer.
you have used HPLC method for
same API.
6. How it could be justified that the We have scanned both API’s on UV spectrophotometer
results of dissolution analysis for and spectrum observed that both API’s shows different
Metformin as performed by UV Lambda max absorbance point i.e. as 232nm for
method have not been interfered Metformin and 266.5 nm for Sitagliptin and also spectrum
with the ingredients of formulation of Inosita Plus XR tablets have been taken and no
specially the other API i.e. interference observed of Sitagliptin.
Sitagliptin, present in the same Firm has submitted UV spectrums for Metformin,
sample aliquot. Sitagliptin and Inosita XR tablet.
in January 2017.
29, North West Industrial 50/500 Dy. No: JANUMET XR
Sitagliptin phosphate Tagipmet XR by M/s
monohydrate eq. to Highnoon
Sitagliptin…...50mg (Reg.#084649)
Metformin HCI
…….. 500mg (as
extended release)
Anti diabetic
Remarks:
2017.”
Description of Pack
No. of Batches 03
No.
1. COA of API
Yes
09-2018.
spx
3. Protocols followed for conduction of stability study
Yes
Karachi.
documents.
Yes
Yes
1978.
 Justification of use of exactly 10 % excess of Sitagliptin in master formulation.

1. The batch no. of Sitagliptin as mentioned Firm has submitted COA of Sitagliptin from M/s
on Stability Study data sheet is different Zheijiang Tianyu Pharmaceutical Co., Ltd. with batch no.
from that mentioned on submitted COA of of 12300-160701. Firm has also inhouse analytical report
Sitagliptin from Supplier which raise for said batch no. of API wherein inhouse QC Lot No.
question on genuineness of submitted “16M0300R” has been assigned to API batch number of
data. batch no. of 12300-160701. Firm has also submitted
attested commercial invoice, Form 3 , Form 7 & Airway
mentioned in Stability data sheet i.e. 03- sample receiving date from PD for initial testing of
01-2017 is different from that mentioned Stability batch.
on Stability summary sheets & Raw data
sheets i.e. 09-01-2017.
3. Justification of use of 10 % excess amount 10% overage was used to cover losses during coating since
of Sitagliptin in master formulation Sitagliptin is being used in coating. However, finished
tablet has no overage which is provided by Analytical
well in limit.
formulation, manufacturing method do formulation and manufacturing method do not have
not have any issue/effective date. issue/effective date.
5. Clarification/ Scientific justification is We have adapted testing method for Metformin XR tablets
required since you have used UV method from USP as in USP assay of Metformin XR tablet is done
in dissolution testing for Metformin while by HPLC and Dissolution testing is carried out by UV
in Assay testing you have used HPLC spectrophotometer.
method for same API.
6. How it could be justified that the results We have scanned both API’s on UV spectrophotometer
of dissolution analysis for Metformin as and spectrum observed that both API’s shows different
performed by UV method have not been Lambda max absorbance point i.e. as 232nm for
interfered with the ingredients of Metformin and 266.5 nm for Sitagliptin and also spectrum
formulation specially the other API i.e.
Sitagliptin, present in the same sample of Inosita Plus XR tablets have been taken and no
aliquot. interference observed of Sitagliptin.
Firm has submitted UV spectrums for Metformin,
Sitagliptin and Inosita XR tablet.
in January 2017.
Report on Investigation of Authenticity / Genuineness of submitted stability data

Report on Investigation of Authenticity / Genuineness of data submitted for registration of Inosita Plus XR
100mg/1000mg, Inosita Plus XR 50mg/1000mg and Inosita Plus XR 50mg/500mg (Sitagliptin / Metformin)
Tablets by M/s. Pharmevo (Pvt) Ltd., Karachi.

Investigation Date and Time: 22nd June, 2018. (Morning).
Investigation Site: M/s Pharmevo (Pvt) Ltd, Karachi.
Background:
Chairman registration has approved the following panel for onsite investigation to confirm genuineness
and/authenticity of stability data and associated documents, import of API, quality, specification, test analysis,
facilities etc. It was also advised to verify the following points:
1. Applied technology of active coating for Sitagliptin in which Drug is loaded via coating solution on the
core tablet of Metform hydrochloride.
2. Justification of 10% overage of Sitagliptin in master formulation (which is required to be based on
study/scientific rationale) for which firm has stated that Stiagliptin overage was inducted due to drug loss
during spray coating process and to attain the satisfactory contents of Sitagliptin as per claim.
3. Method development study to justify that the results of dissolution analysis for Metformin as performed by
UV method have not been interfered with the ingredients of formulation, specially the other API i.e.
Sitagliptin, present in the same sample aliquot.
1. Prof. Dr. Ghulam Sarwar, Dean, Faculty of Pharmacy, Jinnah University for Women, 5-C, St-1,
Nazimabad, Karachi. (Member Registration Board)
2. Dr. Saif-ur-Rehman Khattak, Director / FGA, CDL, DRAP, 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.

Details of Investigation:
Q.No. Question Observation by panel
1. Do you have documents confirming the The firm has used Si t agl i pt i n ( as P hosphate
Import of Sitagliptin and Metformin APIs Monohydrat e) f r om commer ci al l ot of 200Kg
including approval from DRAP? from M/S Zhejiang Tianyu China and Metformin HCl
from commercial lot of 1250Kg from M/S Smruthi
Organics India for the manufacturing of lab scale
batches of INOSITA PLUS XR 50/500mg, 50/1000mg
& 100/1000mg Tablets. The firm has proper approval
for the import of the API from DRAP, Karachi.
2. What was the rationale behind selecting The rationale behind selecting the particular sources of
the particular manufacturer of APIs? APIs is the laid down criteria of the firm in their Vendor
Evaluation procedure which include the GMP status of
the firm, DMF source and capability to provide APIs
reference standard and impurity standard etc.
3. Do you have documents confirming the Firm has Sitagliptin and Metformin working standards
import of Sitagliptin and Metformin and 03 impurities standards of Metformin. Impurity
reference standards and impurity standards? standards of Sitagliptin are under procurement from USP.
4. Do you have certificate of Analysis of the The firm has certificates of analysis for APIs,
API, reference standards and impurity working standards of the APIs and impurities
standards? standards (Related Substances) of Metformin
5. Do you have GMP certificates of APIs Firm provided copy of GMP certificates issued by
manufacturers issued by regulatory authority the country of origin of manufacturer (Sitagliptin) from
of country of origin? Zhejiang FDA and GMP certificate from SFDA and
(Metformin) from FDA, M.S. Bandra Mumbai.
6. Do you use API manufacturer method of The firm u s e d U S P m e t h o d o f t e s t i n g f o r APIs
testing for testing APIs? testing
7. Do you have stability studies reports on The firm has stability studies reports on APIs.
APIs?
8. If yes, whether the stability testing has The stability testing has been performed as per SIM
been performed as per SIM method and Method. Since there is no degredation product therefore
degradation products have been quantification for any degredation product has not been
quantified? made however related substances are properly
quantified throughout the stability testing.
9. Do you have method for quantifying the The firm has used USP method for quantifyi ng
impurities in the APIs? the i mpurities in the Metfor min whereas t he
impurities in Sitagliptin yet to be quantified.
10. Do you have some remaining quantities of Firm has some quantities of the APIs, USP
the APIs, their reference standard and r e f e r en c e standards of the APIs and USP
impurities standards? Impurities standards of Metformin
11. Have you used pharmaceutical grade The firm has used pharmaceutical grade excipients
excipients? Which include HPMC 90SH-100000SR, PVP K-90,
Propyl Gallate, Polyethylene Glycol 6000, Colloidal
Silicon Dioxide, Sodium Stearyl Fumerate, HPMC
Pharmacoat 606
12. Do you have documents confirming the The firm has necessary documents confirming the
import of the used excipients? import of the used excipients.
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.
14. Do you have written and authorized The firm has written and authorized protocols for
protocols for the development of INOSITA the development of Insotia Plus XR 50/500mg,
PLUS XR 50/500mg, 50/1000mg, 50/1000mg, 100/1000mg Tablets
100/1000mg Tablets
15. (Sofosbuvir+Velpatasvir)
Have you performed Tablets ?
Drug-excipient The firm has not performed Drug-excipient
compatibility studies? compatibility studies as the composition of their tablets
is similar to that of the innovator product (Janumet XR
Tablets of MSD USA)
16. Have you performed comparative The firm has performed comparative dissolution
dissolution studies? studies in three mediums for all strengths Inosita Plus XR
50/500mg, 50/1000mg & 100/1000mg Tablets. All the
three potencies of the tablets of the firm show
comparable dissolution profile with that of the innovator
tablets.
17. Do you have product development (R&D) The firm has dedicated R&D section with
section? reasonable facilities of equipments, human resource and
utilities. Some other new equipment like compression
machine, mixer / granulator and FB dryer and lab scale
china coata have been procured.
18. Do you have necessary equipments The firm has all necessary equipments related to
available in product development section manufacturing available in R&D section for
for development of Inosita Plus XR Tablets? manufacturing of I n o s i t a P l u s X R T a b l e t s .
Firm has added some new manufacturing equipment in
the existing list of equipments as mentioned above. The
quality control related to development work has been
done in the routine quality control laboratory; however,
there are dedicated HPLCs and Human Resource for
this purpose.
19. Are the equipments in product All the equipments used in product development
development section qualified? are qualified.
20. Do you have proper maintenance / The firm has proper maintenance / calibration
calibration / re-qualification program for programme. Re-qualification program for the
the equipment used in PD section? equipment used in PD section as needed.
21. Do you have qualified staff in product The firm has 05 pharmacists and 01 chemist in
development section with proper manufacturing section of product development section
knowledge and training in product currently with suitable knowledge and training in product
development?
22. Have you manufactured three stability The firm has manufactured three stability batches
batches for the stability studies of for the stability studies of each strength:
Inosita Plus XR tablets as required? Inosita Plus XR 50/500mg Tablets with Batch Number:
17PD-2053-03-T, 17PD-2054-04-T, 17PD-2055-05-T
Inosita Plus XR 50/1000mg Tablets with Batch Number:
17PD-2056-02-T, 17PD-2057-03-T, 17PD-2058-04-T
Inosita Plus XR 100/1000mg Tablets with B. Number:
17PD-2059-02-T, 17PD-2060-03-T, 17PD-2061-04-T
each of 2500 tablets respectively. The tablets are packed
in Alu / Alu blisters with pack size of 3x7’s.
The manufacturing process is wet granulation.
23. Do you have any criteria for fixing the DRAP guidelines
batch size of stability batches?
24. Do you have complete record of The firm has complete record of production of
production of stability batches? stability batches.
25. Do you have protocols for stability testing The firm has detailed protocols for stability testing
of stability batches? of stability batches.
26. Do you have developed and validated the The firm has developed and validated stability
method for testing of stability batches? indicating method for testing of their finished
product. This method has been used for 12 months study
on stability batches kept on real time and accelerated
stability testing. The results of 12 months studies have
been thoroughly reviewed and the results are satisfactory
as per specifications
27. Do you have method transfer studies in Method transfer studies have not been done,
case when the method of testing being however, validation of the method has been
used by your firm is given by any other performed.
28. lab? you have documents confirming the
Do The firm has documents confirming the installation
qualification of equipments / instruments and operational qualification of the equipment /
being used in the test and analysis of instruments being used in the test and analysis of
Sitagliptin + Metformin and the finished drug? Sitagliptin + Metformin and the finished drug.
29. Do your method of analysis stability Firm has used an isocratic method for testing of stability
indicating? batches up to 12months. This method has been used upto
12 months studies. To confir m the stabil ity
indicating nature of t he method of testing a
Gradient method has been developed and
validated. The new met hod is based upon forced
degredation studies and i mpurities spi ki ng
studies hence the method is stability ind icating.
The 16 month study has been perfor med on the
new method and proper quantification of the
impurities has been pr ofiled. The study results
show that the assay of both APIs and the
impurities are well within desi gned
specifications.
30. Do your HPLC software 21CFR The HPLC software is 21CFR Compliant as per
Compliant? record available with the firm.
31. Can you show Audit trail reports on Audit trail on the testing reports are available.
Testing of APIs and the finished products?
32. Do you have some remaining quantities of The firm has remaining quantities of the
degradation products and stability batches? finished product. No degredation product is available as
there is no specified degredation product.
33. Do you have stability batches kept on The firm has kept all the three batches of each
stability testing? potency on real time and accelerated stability testing.
Accelerated stability testing is complete whereas real time
studies are underway.
Currently, 16 months studies have been completed with
satisfactory results.
34. Do you have valid calibration status for the The firm has valid calibration status for the
equipments used in Savel tablets equipment used in Inosita Plus XR50/500mg,
production and analysis? 50/1000mg, 100/1000mg Tablets P r o d u c t ion and
analysis.
35. Do proper and continuous monitoring and The firm has 12 stability chambers, 02 for accelerated
control are available for stability chamber? and 10 for real time stability testing. All the chambers
are properly qualified. All the chambers are provided
with continuous power supply and data loggers for
continuous monitoring. The batches in question have
been kept in stability chamber No.1 The data of data
loggers is reviewed every 15th day.
36. Do related manufacturing area, equipment, The manufacturing area provided with
personnel and utilities be rated as GMP necessary qualified equipments and utilities. The
compliant? manufacturing personnel are suitable in number
and qualification to run the manufacturing
processes as per GMP requirements. The environmental
conditions and their controls are also proper. The overall
GMP conditions can be rated as compliant.
37. Any query/observation by the PEC:
1) Applied technology of active coating for 1) The process of coating with added sitagliptin is not
Sitagliptin in which Drug is loaded via a high tech process but a routine process being used
coating solution on the core tablet of other formulations also. The key factors to be
Metform hydrochloride. controlled and monitored are the uniformed
dispersion of the active material in the coating
solution throughout the coating process and the
uniform application of the coating material along
with the dissolved API. In the current case both
contributing factors have been controlled through
(a) continuous mixing of the coating solution (b)
weighing of the tablets with interval to confirm the
desired weight gain. It is further informed that firm
has automatic coating system (China Coata) which
can be rated as more suitable and controlled
equipment as compared to the conventional coating
pan.
2) The coating solution is sprayed via spray gun on the
2) Justification of 10% overage of Sitagliptin tablet bed in coating pan during coating process.
in master formulation (which is required to This process also need exhaust system to evacuate
be based on study/scientific rationale) for the dust particles and water vapors generated during
which firm has stated that Stiagliptin the process of coating. Since the API is dissolved in
overage was inducted due to drug loss the coating solution hence it will also be
during spray coating process and to attain exhausted/lost during the process. Since the proper
the satisfactory contents of Sitagliptin as application of the coating material (specifically
per claim. API) is based upon the weight gain therefore there
is no issue with the content of the API to be
incorporated into the finished product.
3) The product is not yet included in any pharmacopeia
3) Method development study to justify that therefore the assay method and dissolution method
the results of dissolution analysis for have been developed and validated by the firm
Metformin as performed by UV method itself. Since the absorption maxima for sitagliptin
have not been interfered with the and metformin are 266 nm and 233nm respectively
ingredients of formulation, specially the therefore there is no chance of any interference
other API i.e. Sitagliptin, present in the during the analysis through UV spectrophotometer.
same sample aliquot.
Conclusion:
1) On the basis of risk based approach the genuineness/authenticity of the stability data submitted by the
firm for the registration of Inosita Plus XR 50/500mg, 50/1000mg, 100/1000mg Tablets are verifiable to
satisfactory level.
2) The related manufacturing area, equipment, personnel and utilities are GMP compliant and well-suited
for the manufacturing of Inosita Plus XR 50/500mg, 50/1000mg, 100/1000mg Tablets therefore the panel
recommends the registration of Inosita Plus XR 50/500mg, 50/1000mg, 100/1000mg Tablets in the name
of manufacturer.
Decision: Registration Board decided to approve registration of “Inosita Plus XR Tab 50/500, Inosita Plus
XR Tab 50/1000 and Inosita Plus XR Tab 100/1000” of M/s Pharm Evo Pvt Ltd, A-29, North West Industrial
Zone, Light Industrial Zone, Port Qasim,Karachi. Manufacturer will place first three production batches of
all three products on long term stability studies throughout proposed shelf life and on accelerated studies for
six months.
156. Doxab 60mg (Edoxaban) Tablets

157. Doxab 30mg (Edoxaban) Tablets
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Doxab 60mg and
Doxab 30mg (Edoxaban) Tablets by M/s. Pharmevo (Pvt) Ltd., Karachi.
Reference No: F.13-11/2017-PEC dated 15th March, 2018.

Background:
The registration board considered the application of M/s Pharmevo (Pvt) Ltd. In 274th meeting. Chairman
registration has approved the following panel for onsite investigation to confirm genuineness and/authenticity of
stability data and associated documents, import of API, quality, specification, test analysis, facilities etc. The panel
is requested to confirm analytical record for performance of dissolution test on 20-9-2017 as per USFDA
recommendation.

Question
Q. # Observation by panel
1. Do you have documents confirming the The firm has imported Edoxaban 1.2Kg f r om M /S
Import of Edoxaban API including Jiangsu Yongan China for the manufacturing of lab scale
approval from DRAP? batches of DOXAB 30mg & 60mg Tablets. 303.075 gm
of Edoxaban has been used in the manufacturing of three
lab scale batches of Doxab 30mg Tablets and 606.15gm
of Edoxaban in the manufacturing of three lab scale
batches of Doxab 60mg Tablets . The firm has proper
approval for the import of the API from DRAP, Karachi.
2. What was the rationale behind The rationale behind selecting the particular source of API
selecting the particular manufacturer of is the laid down criteria of the firm in their Vendor
API? Evaluation procedure which include the GMP status of
the firm, DMF source and capability to provide API
reference standard and impurity standard.
3. Do you have documents confirming the Firm has documents confirming the import of
import of Edoxaban, reference standard Edoxaban, working standard and 11 specified impurities
and impurity standards? standards.
4. Do you have certificate of Analysis of the The firm has certificates of analysis for API,
API, reference standards and working standards of the API and impurities standards.
impurity standards?
5. Do you have GMP certificate of API Firm h a s copy of GMP certificate issued by
manufacturer issued by the country of origin of manufacturer (Huaian
regulatory authority of Marketsupervision Administration).
country of origin?
6. Do you use API manufacturer method The firm has API manufacturer method for testing the
of API.
testing for testing API?
7. Do you have stability studies reports on The firm has stability studies reports on API.
API?
been performed as per SIM method method and degradation products have been
and degradationproducts have quantified.
been
9. quantified?
Do you have method for quantifying the The firm has API manufacturer method for
impurities in the API? quantifying the impurities in the API, however, the
quantification of the impurities has been done after 20
months of manufacturing the stability batches due to
the unavailability of the impurity standards. The
method has been properly validated.
10. Do you have some remaining quantities Firm has some quantities of the API, working
of standard of the API and Impurities working
the API, its reference standard standards.
and impurities standards?
excipients? and include microcrystalline cellulose ph.102, Cross
Carmellose Sodium, Magnesium Stearate
protocols for the development of DOXAB the development of D O X A B 3 0 m g & 6 0 m g
30mg & 60mg Tablets? Tablets
15. Have you performed Drug- The firm has not performed Drug-excipient
excipient compatibility studies as the composition of their tablets is
compatibility studies? similar to that of the innovator product (Lixiana Tablets
of Daiichi Sankyo Germany).
16. Have you performed The firm has performed comparative dissolution studies
comparative with innovator (Lixiana Tablets)
dissolution studies?
17. Do you have product development The firm has dedicated R&D section with
(R&D) reasonable facilities of equipments, human resource and
section? utilities. Some other new equipment like compression
machine, mixer / granulator and FB dryer and lab scale
china coata have been procured.
18. Do you have necessary The firm has all necessary equipments related to
equipments manufacturing available in R&D section for
available in product development manufacturing of D o x a b 3 0 m g & 6 0 m g
section for development of Doxab 30mg T a b l e t s . Firm has added some new manufacturing
& 60mg Tablets? equipment in the existing list of equipments as mentioned
above. The quality control related to development work
has been done in the routine quality control laboratory;
however, there are dedicated HPLCs and Human
Resource for this purpose.
19. Are the equipments in All the equipments used in product development
product are qualified.
development section qualified?
20. Do you have proper maintenance The firm has proper maintenance / calibration
/ programme. Re-qualification program for the
calibration / re-qualification program equipment used in PD section as needed.
for the equipment used in PD section?
development section with manufacturing section of product development section
proper knowledge and training currently with suitable knowledge and training in product
in product
22. development?
Have you manufactured three stability The firm has manufactured three stability batches
batches for the stability studies for the stability studies of:
of Doxab 30mg Tablets with Batch Numbers:
Doxab 30mg & 60mg Tablets as required? 16PD-1887-02-T, 16PD-1888-03-T & 16PD-1889-04-T
Doxab 60mg Tablets with Batch Numbers:
16PD-1891-02-T, 16PD-1892-03-T & 16PD-1893-04-T
each batch is of 2500 tablets respectively. The tablets
packed in Alu / Alu blisters with pack size of 5x10’s.
The manufacturing process is wet granulation.
24. Do you have complete record The firm has complete record of production of
of stability batches.
25. production
Do you have ofprotocols
stability batches?
for stability testing The firm has detailed protocols for stability testing
26. Do you have developed and validated the The firm has u s e d t h e i r o w n m e t h o d f o r t e s t i n g
method for testing of stability batches? of stability batches upto 18 months. A new
method was provided by the API
manufacturer along with the i mpurities after
18 months of development of stability
batches. The method i s stability indicating as
evident by the spiking studies with the
standards and forced degradation studies.
This new method has been used for 20 months study on
stability batches kept on real time. The results of stability
studies have been thoroughly reviewed and found
satisfactory as per designed specifications.
27. Do you have method transfer studies in Method transfer studies have not been done,
case when the method of testing being however, complete validation of the method has
used by your firm is given by any other been performed.
28. lab?
Do you have documents confirming The firm has documents confirming the installation
the and operational qualification of the equipment /
qualification of equipments / instruments instruments being used in the test and analysis of
being used in the test and analysis of Edoxaban and the finished drug.
Edoxaban and the finished drug?
29. Do your method of analysis stability Firm has used two different methods for testing of
indicating? stability batches. The first method is an isocratic method
used for testing of stability batches up to 18months testing
and this method is not stability indicating. A second
method has been used for 20 months study. This method
is gradient mode and stability indicating.
30. Do your HPLC software The HPLC software is 21CFR Compliant as per
21CFR record available with the firm.
31. Compliant?
Can you show Audit trail reports on Audit trail on the testing reports are available.
API and finished product testing?
32. Do you have some remaining quantities of The firm has remaining quantities of the st abili t y
degradation products and stability bat ches and t he main
batches? degradation products o f their finished product.
33. Do you have stability batches kept on The firm has kept all the three batches on real time
stability testing? and accelerated stability testing. Accelerated study has
been completed whereas real time testing is underway.
Currently, 20 months studies have been completed with
satisfactory results.
34. Do you have valid calibration status for the The firm has valid calibration status for the
equipments used in D o x a b 3 0 m g equipment used in D o x a b tablets production and
& 6 0 m g tablets production and analysis.
35. analysis?
Do proper and continuous monitoring and The firm has 12 stability chambers, 02 for accelerated
control are available for stability chamber? and 10 for real time stability testing. All the chambers
are properly qualified. All the chambers are provided
with continuous power supply and data loggers for
continuous monitoring. The batches in question have
been kept in stability chamber No.8 The data of data
loggers is reviewed every 15th day.
36. Do related manufacturing area, The firm has manufacturing area provided with
equipment, necessary qualified equipments and utilities. The
personnel and utilities be rated as GMP manufacturing personnel are suitable in number
compliant? and qualification to run the manufacturing
processes as per GMP requirements. The environmental
conditions and their controls are also proper. The overall
GMP conditions can be rated as compliant.
37. Any query/observation by PEC: The dissolution test data was reviewed thoroughly. The
The panel must confirm the analytical Audit Trail of testing on 20/09/2017 on HPLC was also
record for performance of dissolution test on seen within the chromatograph. The related log books of
20/09/2017 as per USFDA Dissolution test apparatus and HPLC were also checked.
recommendations. It was concluded that the dissolution test has been
performed as per USFDA recommendations.
Conclusion:
1) On the basis of risk based approach the genuineness/authenticity of the stability data submitted by the firm
for the registration of Doxab 30mg & 60mg Tablets are verifiable to satisfactory level.
2) The related manufacturing area, equipment, personnel and utilities are GMP compliant and well-suited for
the manufacturing of Doxab 30mg & 60mg Tablets. Therefore the panel recommends the registration of
Doxab 30mg & 60mg Tablets in the name of the manufacturer.
Decision: Registration Board decided to approve registration of “Doxab 30mg (Edoxaban) Tablets and
Doxab 60mg (Edoxaban) Tablets of M/s Pharm Evo Pvt Ltd, A-29, North West Industrial Zone, Light
Industrial Zone, Port Qasim,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
Strength), fee),
Group, Remarks
Finished Product
Specification
158. M/s CCL Pharmaceuticals Sita-Met XR Tab Form-5-D USFDA Approved.
Pvt Ltd, 62 Industrial 50/500 Dy. No: Not mentioned JANUMET XR
Estate, Kot Lakhpat, Tablet Dated.08-04-2013 By MERCK SHARP
Lahore. Each tablet contains: Rs.50,000/- DOHME
Sitagliptin phosphate As per SRO
monohydrate e//q. to 10’s,14’s,30’s Tagipmet XR by M/s
Sitagliptin….....50mg USFDA Approved. Highnoon
Metformin HCI JANUMET XR (Reg.#084649)
…….. 500mg By MERCK SHARP
DOHME
Previous Remarks:
Firm has submitted Stability Studies conducted as per decision of 251st meeting of the Board.
Previous Decision:
Registration Board in its 260th meeting referred the case for on-site verification of stability data by panel
comprising of Director DTL, Peshawar, Lahore and area FID, DRAP.
Evaluation by PEC:
The Firm has submitted new stability study data for evaluation with following statements:
“It is clarified that initially stability study submitted in February 2016 was as per in house specifications and
later on we developed product as per Innovator specifications and conducted stability accordingly.”
Firm has submitted revised master formulation, manufacturing method & finished product testing method.
STABILITY STUDY DATA SUBMITTED ON 15-12-2017
Drug Sita-Met XR Tab 50/500
Name of Manufacturer M/s CCL Pharmaceutical Lahore.
Manufacturer of API Sitagliptin: M/s Beijing Huikang Boyuan Chemical tech Co.,Ltd. Liaoning
Province, China.
Metformin hydrochloride: M/s Wanbury Ltd., Maharashtra , India
API Lot No. Sitagliptin: 170103
Metformin hydrochloride: MF19351216
Description of Pack
Batch No. T3/17 T4/17 T5/17
Date of Initiation 03-2017 03-2017` 03-2017
No. of Batches 03
No.
1. COA of API
Yes
2. Approval of API by regulatory authority of country Sitagliptin: Copy of Audit report on GMP certificate
of origin or GMP certificate of API manufacturer issued to M/s Beijing Huikang Boyuan Chemical tech
issued by regulatory authority of country of origin. Co.,Ltd. Liaoning Province, China by Liaoning Fuxin
management Committee for Fluoride Industrial
Development Zone, valid upto 10-01-2019. The
relevant provincial authority for issuance of GMP
certificate is Liaoning Food & Drug Administration.
GMP/CERT/KD/476691/2016/11/16413) issued by
FDA Maharashtra valid upto 29-08-2018.
Yes
attested by ADC, DRAP Lahore.
Lahore.
documents.
Yes
Yes
1978.
 In contrary to reference product approved by USFDA, wherein the applied formulation contains 64.25 mg
Sitagliptin phosphate monohydrate (equivalent to 50 mg Sitagliptin as free base), while you have used 70.67mg
Sitagliptin phosphate monohydrate (equivalent to 55.21mg Sitagliptin as free base). Clarification is required in
this regard.
 The covering letter (Letter No. CCL/17/R-1023 dated 21-12-2017) submitted with stability study data states
that we developed product as per Innovator specifications and conducted stability accordingly whereas
reference mentioned for finished product testing method is “Manufacturer’s specifications”. Clarification is
required in this regard.
 The average weight of each tablet mentioned in finished product specifications does not correspond to quantities
of ingredients mentioned in master formulation. Clarification is required in this regard.
 The documents of master formulation, manufacturing method & finished product specifications do not have
any issue/effective date and bears scanned signatures of General Manager Production & Quality Control
Manager.
 You have submitted copy of Audit report on GMP certificate, issued to M/s Beijing Huikang Boyuan Chemical
tech Co., Ltd. Liaoning Province, China (source for Sitagliptin phosphate monohydrate) by Liaoning Fuxin
management Committee for Fluoride Industrial Development Zone whereas the relevant provincial authority
for issuance of GMP certificate is Liaoning Food & Drug Administration. Submit GMP certificate of API
manufacturer issued by relevant regulatory authority of country of origin.
 Upon communication of above observations vide letter no. F.1-1/2017/PEC-DRAP (AD PEC-II) dated 27-12-
2017 the firm replied as under vide its letter no. CCL/18/R-50 dated 19-01-2018:
“It is submitted that DML and GMP certificate of our API (Sitagliptin) source i.e. M/s Beijing Huikang Boyuan
Chemical Tech Co., ltd., China, issued by their provincial Regulatory authority/CFDA is not available.
Therefore, we withdraw our stability study data submitted vide our letter no. CCL/17/R-986, no. CCL/17/R-
987 & no. CCL/17/R-988 dated 14-12-2017. We regret for any inconvenience in this regard.
Further, it is submitted that we have developed said products with another authentic US FDA/ EU approved
source and its stability studies are in process, which will be submitted to DRAP soon.”
Fresh Evaluation by PEC:
The Firm has submitted new stability study data for evaluation vide letter no. CCL/18/R-99 dated 14-02-2018,
details of which are as under:
NEW STABILITY STUDY DATA SUBMITTED ON 15-02-2018
Manufacturer of API Sitagliptin: M/s Ruyuan HEC Pharm Co., Ltd. China
API Lot No. Sitagliptin: STP-RD201702203B
Description of Pack
Batch No. T6/17 T7/17 T8/17
Date of Initiation 23-05-2017 23-05-2017 23- 05-2017
No. of Batches 03
No.
1. COA of API Yes
2. Approval of API by regulatory authority of country
Sitagliptin: Yes
of origin or GMP certificate of API manufacturer
issued by regulatory authority of country of origin. Metformin hydrochloride: Copy of GMP certificate
Yes
attested by ADC, DRAP Lahore dated 14-04-2017.
Lahore dated 20-02-2017.
documents.
Yes
Yes
1978.
 Firm has applied technology of Active coating for Sitagliptin in which Drug is loaded via coating solution on
the core tablet of Metformin hydrochloride.
 Firm has mentioned 5% overage of Sitagliptin in master formulation stating that Sitagliptin overage inducted
due to drug loss during spray coating process and to attain the satisfactory contents of Sitagliptin as per claim.
Strength), fee),
Group, Remarks
Finished Product
Specification
159. M/s CCL Pharmaceutical Sita-Met XR Tab Form-5-D USFDA Approved.
Lahore. 100/1000 Dy. No: N/A JANUMET XR
Tablet Dated.08-04-2013 By MERCK SHARP
Each tablet contains: Rs.50,000/- DOHME
Sitagliptin phosphate As per SRO Tagipmet XR by M/s
monohydrate eq. to 10’s,14’s Highnoon
Sitagliptin (Reg.#084651)
................100mg
Metformin
hydrochloride
…..….. 1000mg
(Anti Diabetic)
Previous Remarks:
Previous Decision:
Evaluation by PEC:
Now the Firm has submitted new stability study data for evaluation with following statements:
“It is clarified that initially stability study submitted din February 2016 was as per in house specifications
and later on we developed product as per Innovator specifications and conducted stability accordingly.”
Province, China.
Description of Pack
Stability Storage Condition Real time : 30°C ± 2°C / 65% ± 5% RH
Accelerated: 40°C ± 2°C / 75% ± 5% RH
Batch No. T2/17 T3/17 T4/17
No. of Batches 03
No.
1. COA of API
Yes
Yes
Lahore.
documents.
Yes
Yes
1978.
 The Stability protocol submitted with stability data has issue date of 20-04-2017 whereas storage date for trial
batches is mentioned as18-04-2017 in the stability study data sheet. Clarification is required in this regard.
Sitagliptin phosphate monohydrate (equivalent to 100 mg Sitagliptin as free base), while you have used
141.35mg Sitagliptin phosphate monohydrate (equivalent to 110.42mg Sitagliptin as free base). Clarification
is required in this regard.
 The covering letter with newly submitted data (Letter No. CCL/17/R-1023 dated 21-12-2017) submitted with
stability study data states that we developed product as per Innovator specifications and conducted stability
accordingly whereas reference mentioned for finished product testing method is “Manufacturer’s
specifications”. Clarification is required in this regard.
Manager.
tech Co., Ltd. Liaoning Province, China (suource for Sitagliptin phosphate monohydrate) by Liaoning Fuxin
The Firm has submitted new stability study data for evaluation vide letter no. CCL/18/R-101 dated 14-02-2018,
Description of Pack
Batch No. T5/17 T6/17 T7/17
No. of Batches 03
No.
1. COA of API
Yes
2. Approval of API by regulatory authority of country

Sitagliptin: Yes
of origin or GMP certificate of API manufacturer
issued by regulatory authority of country of origin. Metformin hydrochloride: Copy of GMP certificate
Yes
documents.
Yes
Yes
1978.
Strength), fee),
Group, Remarks
Finished Product
Specification
160. M/s CCL Pharmaceutical Sita-Met XR Tab Form-5-D USFDA Approved.
Lahore. 50/1000 Dy. No: N/A JANUMET XR
Tablet Dated.08-04-2013 By MERCK SHARP
Each tablet contains: Rs.50,000/- DOHME
Sitagliptin phosphate As per SRO Tagipmet XR by M/s
monohydrate eq. to 10’s,14’s Highnoon
Sitagliptin (Reg.#084650)
…................. 50mg
Metformin
hydrochloride
……..…..1000mg
(Anti Diabetic)
Previous Remarks:
Previous Decision:
Evaluation by PEC:
Now the Firm has submitted new stability study data for evaluation with following statements:
“It is clarified that initially stability study submitted in February 2016 was as per in house specifications and
later on we developed product as per Innovator specifications and conducted stability accordingly.”
Province, China.
Description of Pack
Batch No. T3/17 T4/17 T5/17
No. of Batches 03
No.
1. COA of API Yes
Yes
Lahore.
documents.
Yes
Yes
1978.
Sitagliptin phosphate monohydrate (equivalent to 50 mg Sitagliptin as free base), while you have used 70.67mg
Sitagliptin phosphate monohydrate (equivalent to 55.21mg Sitagliptin as free base). Clarification is required in
this regard.
 The covering letter with newly submitted data (Letter No. CCL/17/R-1023 dated 21-12-2017) submitted with
stability study data states that we developed product as per Innovator specifications and conducted stability
accordingly whereas reference mentioned for finished product testing method is “Manufacturer’s
specifications”. Clarification is required in this regard.
Manager.
tech Co., Ltd. Liaoning Province, China (source for Sitagliptin phosphate monohydrate) by Liaoning Fuxin
 The Firm has submitted new stability study data for evaluation vide letter no. CCL/18/R-100 dated 14-02-2018,

Description of Pack
Frequency Accelerated: 0,3,6 (month) Real Time: 0,3,6 (month)
Batch No. T6/17 T7/17 T8/17

Date of Initiation 23-05-2017 23-05-2017 23- 05-2017
No. of Batches 03
No.
1. COA of API Yes
2.
Sitagliptin: Yes
Approval of API by regulatory authority of country Metformin hydrochloride: Copy of GMP certificate
of origin or GMP certificate of API manufacturer (Certificate No. NEW-WHO-
issued by regulatory authority of country of origin. GMP/CERT/KD/47691/2016/11/16413) issued by
Yes
documents.
Yes
Yes
1978.
General Information.
Name of Manufacturer M/s CCL Pharmaceuticals (Pvt.) Ltd.
Physical Address 62-Industrial Estate, KotLakhpat, Lahore.
Drug Manufacturing License No. and validity 000052 by way of formulation
Valid till 20-07-2020.
Contact Address Mr. Irfan Sohail
Senior Manager Regulatory Affairs
0308-8884984
Purpose of Inspection Verification of Authenticity of Stability Data for
Purpose of Registration of Drugs with reference
DRAP’s letter No. F.13-11/2017-PECdated 05-4-2018.
Name of Inspector 01. Dr. Shafiq-ur-Rehman
Director, DTL, Lahore.
02. Mr. Asim Rauf
Additional Director, DRAP, Lahore.
03. Ms. Anam Saeed, Area FID, DRAP, Lahore.
Name of firm Representatives  Dr. Rizwan Mahmood
Director Quality Operations
 Mr. Kamran Atif
Director Regulatory Affairs
 Mr. Shahid Anwar
R&DManager
 Mr. Irfan Sohail
 Mr. Muhammad Fiaz
Quality Control Manager
 Mr. Farhan Qureshi
Quality Assurance Manager
General Information about unit:
The firm is located in the industrial area at 62-Industrial Estate, KotLakhpat, Lahore. The firm was
established in 1965 initially and shifted to the existing site in 1984. The firm has production facility, supply chain,
engineering, quality control, quality assurance, research and development, regulatory and administrative
departments. The production operations at firm involve manufacturing, packaging and distribution of finished
pharmaceutical products. The firm is manufacturing generic products.
Focus of Inspection:
namely:
S. No. Name / Composition of Drugs
01 Sita-Met XR 50/500 Tablet
Sitagliptin phosphate monohydrate eq. to Sitagliptin………….50mg
Metformin hydrochloride………...500mg (as extended release core)
Panel also visited the R&D Laboratory and Quality Control Laboratory of the firm. The data was evaluated
according to the check list provided as given below:
i) Sita-Met XR Tablets50/1000mg, 50/500mg, 100/1000mg
Q. No. Question Observation by panel
1. Do you have documents confirming The firm has imported Sitagliptin raw material 300 Kg from
the import of Sitagliptin + Metformin M/s Ruyuan HEC Pharm, China on 14.04.2017 and
HCl APIs including approval from Metformin HCl 5,000 Kg from M/s Wanbury Limited, India
DRAP? on 21.02.2017 through DRAP, Lahore.
2. What was the rationale behind Firm informed that they selected M/s Ruyuan HEC Pharm,
selecting the particular manufacturer China and M/s Wanbury Limited, India due to previous
of API? confidence in same manufacturer of API.
3. Do you have documents confirming Firm imported Sitagliptin reference standard (160mg) from
the import of Sitagliptin reference EDQM, France through DRAP dated 20.05.2016 and
standard and impurity standards? impurity standard (20mg) from USP, USA via airway bill
dated 18.12.2016.
Firm imported Metformin HCl reference standard (200mg)
from USP, USA via airway bill dated 02-11-2014 and
impurity standard (30mg) from USP, USA via airway bill
dated 18.12.2016.
4. Do you have certificate of Analysis of The firm had certificates of analysis for APIs, reference
the API, reference standards and standards and impurities standards.
impurity standards?
5. Do you have GMP certificate of API Firm had provided valid GMP Certificate of M/s Ruyuan
manufacturer issued by regulatory HEC Pharm, issued by FDA, Shaoguan, China.
authority of country of origin? Firm had provided valid GMP Certificate of M/s Wanbury
Limited, issued by FDA, Maharashtra, India.
6. Do you use API manufacturer method The firm used API manufacturer’s method of testing which
of testing for testing API? was validated and the method was validated by the
manufacturer
7. Do you have stability studies reports The firm had stability studies reports on APIs of raw
on API? material manufacturers.
been performed as per SIM method (PTM-303, PTM-304 and 305) and degradation products
and degradation products have been had been quantified.
quantified?
9. Do you have method for quantifying Firm had testing method to quantify the impurities as per
the impurities in the API? raw material manufacturer. Impurities in Stagliptin
Phosphate Monohydrate were: (Single impurity (NMT
0.5%) and total Impurities (NMT 1%).
Impurities in Metformin HCI were: (Cyanoguanidine NMT
0.02%, other impurities NMT 0.1%)
10. Do you have some remaining Both APIs were routinely imported by the firm and used in
quantities of the API, its reference other registered products also. Remaining quantity of
standard and impurities standards? sitagliptin reference standard was 148.59mg and impurity
standard was 10mg while Metformin HCI reference
standard was 135.8mg and impurity standard was 10mg
11. Have you used pharmaceutical grade The firm had used pharmaceutical grade excipients
excipients? including Kollidon K-30, Avicel PH 102, Aerosil-200,
Methocel K100M and Sodium Stearyl Fumarate.
12. Do you have documents confirming The firm had necessary documents confirming the import of
the import of the used excipients? the used excipients.
13. Do you have test reports and other The firm had test reports and other records on the excipients
records on the excipients used? used.
protocols for the development of development of Sitagliptin + Metformin HCl XRTablets.
Sitagliptin + Metformin HClXR
Tablets?
15. Have you performed Drug-excipient The firm had performed Drug-excipient compatibility
compatibility studies? studies.
16. Have you performed comparative The firm had performed comparative dissolution studies for
dissolution studies? Sita-Met XR 50mg/1000mgTablet with Janumet XR Tablet
50mg/1000mg, manufactured by M/s MSD, USA and
results were in acceptable limits. 12 Station Dissolution
Apparatus to meet USP criteria was not used.
17. Do you have product development The firm had product development (R&D) section.
(R&D) section
available in product development develop Sitagliptin + Metformin HCl XR Tablets.
section for development of Sitagliptin
+ Metformin HCl XR Tablets?
19. Are the equipment in product The available equipment in product development section
development section qualified? were qualified.
20. Do you have proper maintenance / The firm had proper maintenance / calibration / re-
calibration / re-qualification program qualification program for the equipment used in product
for the equipment used in PD section? development section.
21. Do you have qualified staff in product The firm had 09 Pharmacists and 01 Chemists in product
development section with proper development section with suitable knowledge and training
knowledge and training in product in product development.
development?
batches for the stability studies of stability studies of Sitagliptin + Metformin HCl XR Tablets
Sitagliptin + Metformin HCl XR (50/500mg, 50/1000mg and 100/1000mg) with batch
Tablets as required? numbers i.e. T6/17, T7/17 and T8/17 for 50/500mg and
50/1000mg strength, and T5/17, T6/17 and T7/17 for
100/1000mg strength The Batch size for these batches was
3,000 tablets each.
23. Do you have any criteria for fixing the The firm had criteria for fixing the batch size of stability
batch size of stability batches? batches as per CQP-004-G in the light of DRAP letter No.
F.3-2/2014-I&E dated 08-12-2015.
production of stability batches? batches.
25. Do you have protocols for stability The firm had detailed protocols for stability testing of
testing of stability batches? stability batches.
batches? manufacturer.
27. Do you have method transfer studies in NA
case when the method of testing being
lab?
28. Do you have documents confirming The firm had documents confirming the qualification of
the qualification of equipment / equipment / instruments being used in the test and analysis
instruments being used in the test and of Sitagliptin + Metformin HCl API and the finished drug.
analysis of Sitagliptin + Metformin
HCl API and the finished drug?
indicating? indicating and record of testing of stability batches was
available.
30. Do your HPLC software 21CFR The firm had recently procured the software but the HPLC
Compliant? used in stability studies was not 21 CFR 11 compliant.
Stability data was protected through internal controls.
31. Can you show Audit trail reports on Log of data was available in the HPLC. Audit trial was not
Sitagliptin + Metformin HCl testing? ON
32. Do you have some remaining The firm had remaining quantities (108 tablets of each
quantities of degradation products and batch) of stability batches.
stability batches?
33. Do you have stability batches kept on The firm had stability batches kept on stability testing. The
stability testing? firm had commitment for stability studies of commercial
batches.
34. Do you have valid calibration status The firm had valid calibration status for the equipment used
for the equipment used in Sitagliptin + in Sitagliptin + Metformin HCl tablets production and
Metformin HCl tablets production and analysis.
analysis?
and control are available for stability chamber.
chamber?
Clarification of Applied technology and 5 % overage of Sitagliptin:

Metformin XR core tablet was prepared by the firm by Dry Granulation Method then Sitagliptin was loaded
via Aqueous based coating solution on the core tablet in Thai coater. 5% overage of Sitagliptin was inducted by
the firm in master formulation due to drug loss during spray coating process. Initial trials were conducted without
overage and Assay results of Sitagliptin were 96% and 95.5% (Annex-A &B) which was subsequently increased
to 102% by inducting 5% overage (Annex C &D). So the stability batches were prepared by inducting 5 % overage.
However the firm made a commitment to reduce the overage when commercial manufacturing will be done.
RECOMMENDATIONS:
Based on the area inspected, the technical personnel met and the documents reviewed, and considering the
findings of inspection, the panel is of the opinion that the data provided by the firm M/s. CCL Pharmaceuticals
(Pvt.) Ltd., 62-Industrial Estate, Kot Lakhpat, Lahore regarding stability studies of following products was
satisfactory and the stability studies were conducted by the firm.
i) Sita-Met XR Tablet 50/1000mg, 50/500mg&100/1000mg
Remarks by PEC:
 Submitted on-site investigation report mentions that Metformin XR core tablet was prepared by the firm
by Dry Granulation Method, whereas “Manufacturing protocol for Sitamet XR” tablet range i.e. MP-303,
MP-306 & MP-308 states that Metformin XR core tablet is prepared by Wet Granulation Method using de-
ionized water as granulating solvent.
Decision: Registration Board deferred the applications of Sita-Met XR Tablet 50/1000mg

50/500mg&100/1000mg for clarification from the firm regarding following observation:
“On-site investigation report mentions that Metformin XR core tablet was prepared by the firm by Dry
Granulation Method, whereas “Manufacturing protocol for Sitamet XR” tablet range i.e. MP-303, MP-306
& MP-308 states that Metformin XR core tablet is prepared by Wet Granulation Method using de-ionized
water as granulating solvent.”
161. Glukana Tablet 100mg
162. Glukana Tablet 300mg
Registration board in its 275th meeting held on 25-27th October, 2017, decided to constitute following panel to
confirm genuineness/ authenticity of stability data and associated documents, import of API, quality, specification,
test analysis, facilities etc, for the above mentioned products
 Director, Drug Testing Laboratory Government of Punjab, Lahore.
 Additional Director, Drug Regulatory Authority of Pakistan, Lahore.
 Area FID, DRAP, Lahore.
0308-8884984
DRAP’s Letters No. F.2-16/2016-PEC(M-275)
dated 15-01-2018.
02. Mr. Asim Rauf
03. Ms. Anam Saeed,
Area FID, DRAP, Lahore.
R&DManager

The firm is located in the industrial area at 62-Industrial Estate, Kot Lakhpat, Lahore. The firm was
namely:
01 Glukana Tablet 100mg
Canagliflozin (as hemihydrate)…….100mg
02 Glukana Tablet 300mg
Canagliflozin (as hemihydrate)…….300mg
1. Do you have documents confirming The firm had imported Canagliflozin raw material 2.25Kg
the import of Canagliflozin API from M/s Nantong Chanyoo Pharmatech Co., Ltd.,China via
including approval from DRAP? DHL dated 07.09.2015.
2. What was the rationale behind Firm informed that they selected M/s Nantong Chanyoo
selecting the particular manufacturer PharmatechCo., Ltd., China due to previous confidence in
of API? same manufacturer of API.
3. Do you have documents confirming Firm informed that 2.4 gm Canagliflozin working standard
the import of Canagliflozin reference was imported along with API but it was not mentioned on
standard and impurity standards? invoice of API so couldn’t be verified while 50mg impurity
standards (5 standard of 10mg each) were imported from
M/s Nantong Chanyoo Pharmatech Co., Ltd., China via
DHL dated 20.03.2017.
4. Do you have certificate of Analysis of The firm had certificates of analysis for API, working
the API, reference standards and standard and impurity standards.
impurity standards?
5. Do you have GMP certificate of API Firm had provided valid GMP certificate.
manufacturer issued by regulatory
6. Do you use API manufacturer method The firm used API manufacturer’s method of testing which
of testing for testing API? was validated by the manufacturer.
on API? manufacturer.
been performed as per SIM method {PD-PTM-006) and (PD-PTM-007} and degradation
and degradation products have been products had been quantified.
quantified?
9. Do you have method for quantifying Firm had testing method to quantify the impurities as per
the impurities in the API? r w material manufacturer. The quantified impurities are
Ring opening CLF (≤0.15%), Desfluoro of CLF (≤0.15%),
α-CLF (≤0.15%), CLF-4 (≤0.15%), Pentatomic ring of CLF
(≤0.15%), Any unknown impurity (≤0.10%), Total
impurities (≤1.0%).
10. Do you hav some rema ning The firm had some remaining quantities f the API
quantities of the API, its reference (610.2gm) and working standard (30mg) but did not have
standard and impurities standards? remaining quantity of impurities.
11. Have you used pharmaceutical grade The firm had used pharmaceutical grade excipients
excipients? including Lactose Monohydrate, Avicel PH 102, Klucel
EXF, Croscarmel lose Sodium, Magnesium Stearate and
Sodium Stearyl Fumarate.
14. Do you have written and authorized The firm had written and authorized protocol for the
protocols for the development of development of Canagliflozin 100mg & 300mg tablets. Wet
Canagliflozin tablets? Granulation method was adopted.
15. Have you performed Drug-excipient
The firm had performed Drug-excipient compatibility
dissolution studies? Canagliflozin Tablet 300mg with Invokana Tablet 300mg,
manufactured by M/s Janssen-Cilag, USA and results were
in acceptable limits. 12 station Dissolution Apparatus to
meet USP criteria was not used.
(R&D) section
available in product development develop Canagliflozin tablets 100mg and compression
section for development of machine of production section was used for Canagliflozin
Canagliflozin 100mg & 300mg tablets 300mg.
tablets?
21. Do you have qualified staff in product The firm had09 Pharmacists and one Chemist in product
development section with proper development section with suitable knowledge and training
knowledge and training in product in product development.
development?
22. Have you manufactured three stability
The firm had manufactured three stability batches for the
batches for the stability studies of
stability studies of Canagliflozin 100mg & 300mg tablets
Canagliflozin 100mg & 300mg tablets
with batch number i.e. T2/15, T3/15 and T4/15 respectively.
as required? The Batch size for these batches was 1,000 tablets each.
23. Do you have any criteria for fixing the
The firm had criteria for fixing the batch size of stability
batch size of stability batches? batches as per CQP-004-H in the light of DRAP letter No.
F.3-2/2014-I&E dated 08-12-2015.
lab?
the qualification of equipment / of equipment / instruments being used in the test and
instruments being used in the test and analysis of Canagliflozin API and the finished drug.
analysis of Canagliflozin API and the
finished drug?
29. Do your method of analysis stabilityFirm had validated testing method which was stability
available.
Compliant? used in stability studies was not 21 CRF 11 compliant. The
stability data was protected through internal controls.
31. Can you show Audit trail reports on Log of data was available in the HPLC and was checked.
Canagliflozin testing? Audit trail was not ON
32. Do you have some remaining The firm had remaining quantities (expired 36 tablets) of
quantities of degradation products and stability batches.
stability batches?
33. Do you have stability batches kept on The shelf life (2 years) of stability batches has been
stability testing? completed.
for the equipment used in in Canagliflozin tablets production and analysis.
Canagliflozin tablets production and
analysis?
chamber?
RECOMMENDATIONS:
Based on the area inspected, technical personnel met and the documents reviewed, and considering the
findings of the inspection, the panel is of the opinion that the data provided by the firm M/s. CCL Pharmaceuticals
i) Glukana Tablet 100mg & 300mg
Decision: Registration Board decided to approve registration of “Glukana Tablet 100mg (Canagliflozin as
hemihydrate…….100mg) & Glukana Tablet 300mg (Canagliflozin as hemihydrate…….300mg) of M/s CCL
Pharmaceuticals Pvt Ltd, 62 Industrial Estate, Kot Lakhpat, Lahore. Manufacturer will place first three
accelerated studies for six months
163. Apixa Tablet 2.5mg
164. Apixa Tablet 5mg
Registration board in its 275th meeting held on 27-28th July, 2017, decided to constitute following panel to confirm
genuineness/ authenticity of stability data and associated documents, import of API, quality, specification, test
analysis, facilities etc, for the above mentioned products
 Director, Drug Testing Laboratory Government of Punjab, Lahore.
 Additional Director, Drug Regulatory Authority of Pakistan, Lahore.
 Area FID, DRAP, Lahore.


0308-8884984

DRAP’s letters No. F.2-16/2016-PEC(M-272)
dated 07-09-2017.
02. Mr. Asim Rauf
03. Ms. Anam Saeed,
Area FID, DRAP, Lahore.
R&DManager
The firm is located in the industrial area at 62-Industrial Estate, Kot Lakhpat, Lahore. The firm was
namely:
01 Apixa Tablet 2.5mg
Apixaban…………………2.5mg
02 Apixa Tablet 5mg
Apixaban…………………...5mg
1. Do you have documents confirming The firm had imported Apixaban raw material 0.5 Kg from
the import of Apixaban API including M/s Zhejiang Huahai Pharmaceutical Co. Ltd., China via
approval from DRAP? DHL dated 20.05.2015.
2. What was the rationale behind Firm informed that they selected M/s Zhejiang Huahai
selecting the particular manufacturer Pharmaceutical Co. Ltd., China due to previous confidence
of API? in same manufacturer of API.
3. Do you have documents confirming Firm informed that 2.5gm of Apixaban working standard
the import of Apixaban reference was imported along with the API but it was not mentioned
standard and impurity standards? on invoice so could not be verified while 60mg impurity
standards (2 impurities of 30mg each) was imported from
M/s Zhejiang Huahai Pharmaceutical Co. Ltd., China via
DHL dated 20.05.2015.
4. Do you have certificate of Analysis of The firm had certificates of analysis for API, working
the API, reference standards and standard and impurity standards.
impurity standards?
5. Do you have GMP certificate of API Firm had provided valid GMP certificate issued by Zhejiang
manufacturer issued by regulatory FDA.
6. Do you use API manufacturer method The firm used API manufacturer’s method of testing and the
of testing for testing API? method was validated by the manufacturer.
on API? manufacturer.
been performed as per SIM method (PD-PTM 004 and PD-PTM-005) and degradation products
and degradation products have been had been quantified.
quantified?
9. Do you have method for quantifying Firm had testing method to quantify the impurities as per raw
the impurities in the API? material manufacturer. The quantified impurities with their
limits are Methyl ester impurity (NMT 0.15%), Ethyl ester
impurity (NMT 0.15%), any other impurity (NMT 0.10%),
Total impurities (NMT 1.0%).
10. Do you have some remaining The firm had some remaining quantities of the API
quantities of the API, its reference (382.5gm) working standard (100mg) and impurities
standard and impurities standards? (40mg).
11. Have you used pharmaceutical grade The firm had used pharmaceutical grade excipients including
excipients? Lactose Anhydrous, Avicel PH 102, Croscarmellose
Sodium, Magnesium Stearate and Sodium Lauryl Sulphate.
protocols for the development of development of Apixaban 2.5mg, 5mg tablets. Dry
Apixaban tablets? Granulation method was adopted.
15. Have you performed Drug-excipient The firm had performed Drug-excipient compatibility
dissolution studies? Apixaban 5mg Tablets with Eliquis 5mg Tablets,
manufactured by M/s Bristol-Mayers Squibb UK Limited
and results were in acceptable limits. 12 station Dissolution
Apparatus to meet USP criteria was not used.
(R&D) section
available in product development develop Apixaban 2.5mg and 5mg tablets.
section for development of Apixaban
tablets?
21. Do you have qualified staff in product The firm had 09 Pharmacists and one Chemist in product
development section with proper development section with suitable knowledge and training in
development?
batches for the stability studies of stability studies of Apixaban Tablets (2.5mg, 5 mg) with
Apixaban tablets as required? batch numbers i.e. T3/15, T4/15 and T5/15 for each strength.
The Batch size for these batches is 3,000 tablets each.
23. Do you have any criteria for fixing the The firm had criteria for fixing the batch size of stability
batch size of stability batches? batches as per CQP-004-G in the light of DRAP letter No.
F.3-2/2014-I&E dated 08-12-2015.
lab?
the qualification of equipment / of equipment / instruments being used in the test and analysis
instruments being used in the test and of Apixaban API and the finished drug.
analysis of Apixaban API and the
finished drug?
available.
Compliant? used in stability studies was not 21 CRF 11 compliant.
Stability data was protected through internal controls.
31. Can you show Audit trail reports on Log of data was available in the HPLC and was checked.
Apixaban testing? Audit trail was not ON.
32. Do you have some remaining The firm had remaining quantities (expired 36 tablets) of
quantities of degradation products and stability batches.
stability batches?
33. Do you have stability batches kept on The shelf life (2 years) of stability batches has been
stability testing? completed.
for the equipment used in Apixaban in Apixaban tablets production and analysis.
tablets production and analysis?
chamber?
RECOMMENDATIONS:
Based on the area inspected, technical personnel met and the documents reviewed, and considering the
findings of the inspection, the panel is of the opinion that the data provided by the firm M/s. CCL Pharmaceuticals
i) Apixa Tablet 2.5mg & 5mg
Decision: Registration Board decided to approve registration of “Apixa Tablet 2.5mg (Apixaban.. 2.5mg) &
Apixa Tablet 5mg (Apixaban… 5mg) of M/s CCL Pharmaceuticals Pvt Ltd, 62 Industrial Estate, Kot
Lakhpat, Lahore. 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
Strength), fee),
Group, Remarks
Finished Product
Specification
165. M/s Ferozsons Labs, Quench Plus cream Form 5-D
Amangarh, Nowshera Each gram contains: Dairy No. 427 dated 07-02- Ialugen Plus approved
Silver sulfadiazine 2017 by Swissmedic of
…. 10mg Rs.50,000/- (20-10-2016) Switzerland.
Sodium hyaluronate As per DRAP Policy
…. 2 mg
Antibacterial/Mucop
olysaccharide
(Mnf Specs)
Drug Quench Plus cream
Name of Manufacturer M/s Ferozsons Labs, Amangarh, Nowshera

Manufacturer of API Silver sulfadiazine: M/s Lusochimica S.P.A, Italy
Sodium hyaluronate: M/s Contipro Pharma a.s. Czech
API Lot No. Silver sulfadiazine: AGSM116
Sodium hyaluronate: N230616-D1
Description of Pack 1. 250gm cream filled in a HDPE jar, sealed with induction seal &
(Container closure system) capped.
2. 15gm cream filled in Al-tube & crimped and sealed, such one tube
packed in a unit carton
Time Period Real time: 26 weeks
Accelerated: 6 month
Real Time: 0,4,12,26 (weeks)
Batch No. PD17N019 PD17N020 PD17N021
Batch Size 10 Kg 10 Kg 10 Kg
No. of Batches 03
No.
1. COA of API Yes
2. Approval of API by regulatory authority of country Silver sulfadiazine: Copy of Certificate of GMP
of origin or GMP certificate of API manufacturer issued to M/s Lusochimica S.P.A, Italy by Italian
issued by regulatory authority of country of origin. Medicine Agency.
Sodium hyaluronate: Copy of Certificate of GMP
issued to M/s Contipro Pharma a.s. Czech. by State
Institute for Drug Control of Czech Republic
Yes
Raw data sheets and lab reports have not been
submitted with stability studies data.
5. Documents confirming import of API etc. Silver sulfadiazine: Copy of commercial invoice for
Silver sulfadiazine (Batch No. AGSM116) has been
Peshawar.
Sodium hyaluronate: Copy of Form 6 (License to
Import Drugs for Clinical trial examination, Test
analysis) has been submitted issued by ADC,
Peshawar DRAP
documents.
Yes
Yes
1978.
i. The firm has submitted 6 months of Accelerated and Real time Stability Study Data for 03 Batches.
ii. You have conducted stability with two different container closure systems with same batch numbers.
Clarification is required for assigning same batch number to products packed in different container closure
system.
iii. Finish product testing method has not been submitted.
iv. Firm has performed test for Description, pH, Identification, Assay and Microbial testing only during
stability studies, whereas WHO guidelines for Stability testing of active pharmaceutical ingredients and
finished pharmaceutical products recommends as under:
“Topical preparations should be evaluated for clarity, homogeneity, pH, suspendability (for lotions),
consistency, viscosity, particle size distribution (for suspensions, when feasible), level of microbial
contamination/sterility and weight loss (when appropriate).” Also USP chapter <3> titled “Topical and
Transdermal Drug Products – Product Quality Tests”, recommends tests for “Apparent viscosity” and
“Uniformity in Containers” as “Specific Tests For Topically Applied Semisolid Drug Products.”
Clarification is required in this regard.
v. Above observation were communicated to firm vide letter no. F.1-1/2017/PEC-DRAP (AD PEC-II) dated
21-12-2017, to which firm has responded as under vide its letter no. PDFLL-283301081:
Firm has submitted finished product testing method including the test for Apparent Viscosity & Container
Uniformity.
vi. After the communication of observation regarding test for “Apparent viscosity” & “Uniformity in
Containers” firm has performed both tests on three batches at accelerated & real time conditions on samples
withdrawn from both tube & jar containers.
vii. Now firm has submitted summary of results for tests of “Apparent viscosity” & “Uniformity in Containers”,
chromatograms & raw data sheets for test of Uniformity in Containers performed on 28-12-2017.
viii. For test of viscosity firm has stated that limits will be established after the completion of stability studies.
ix. Following clarification has been submitted regarding assigning same batch number to products packed in
different container closure system.
“Batch number is allotted to the manufacturing process of the product. After the batch is manufactured it
is tested for physical & chemical analysis.
The same batch can be filled in multiple container systems to determine the stability of the product in
different container types. This is beneficial because of the product complies in one type and does not
comply in the other one, it can be easily decided that the product is not stable in a particular container type.”
Verification of Authenticity of Stability Data submitted for Registration of Quench Plus Cream (Silver
Sulfadiazine 100mg+ Sodium Hyaluronate 2mg) by M/s Ferozesons Laboratories Ltd, Nowshera
No.F.2-16/2016-PEC (M-277)
Inspection date: 2nd May 2018 (Morning)
Inspection site: Factory Premises of M/s Ferozsons Laboratories Nowshera
The constituted Panel for the verification of authenticity of stability data was comprised of the following members,
1. Director DTL, Peshawar
2. Syed Adnan Ali Shah, Assistant Director PE & R, Islamabad
3. Farhad Ullah, Assistant Director DRAP Peshawar
Due to retirement of the Director DTL, Peshawar the panel was revised as per directions of Director PE&R
Islamabad and Dr. Muhammad Khalid Javed, Senior Government Analyst; DTL Peshawar was included in the
panel in place of Director DTL Peshawar.
The revise constituted panel conducted detailed inspection of M/s Ferozsons Laboratories Ltd, Nowshera, Khyber
Pakhtunkhwa as per following details:
(S.No) Question Observation by panel

Firm has documents confirming the import of both APIs.
 Silver Sulphadiazine Micronized was imported from M/s
Lusochimica S.P.A Via Giotto Lomagna Italy vide
invoice # 229 dated 9/9/2016 with approval of DRAP
Do you have documents Peshawar.
Q.No.1
confirming the import of API  Sodium Hyaluronic Acid was imported from Contipro-
including approval from Czech Republic vide license #00777/2016-DRAP
DRAP? (P)2602 dated 12/08/2016 with approval of DRAP
Peshawar. It is pertinent to mention that import documents
mentions the quantity of API as 1.5 Kg, while the actual
quantity imported was 0.60 Kg (as per consumption
record provided by the firm)
The firm has informed that they have selected the manufacturer
due to following reason (as per firm information);
 For silver sulphadiazine because it is a validated source
What was the rationale behind
used in their already marketed product. Furthermore, the
Q.No.2 selecting the particular
manufacturer is GMP compliant and has provided
manufacturer of API?
stability data.
 For Sodium Hyaluronic Acid on the basis of its GMP
compliance and provision of stability data.
Firm has documents confirming the import of Silver
Sulphadiazine reference standard (source: USA) vide NOC# F-11-
1/2015-Ferozsons-DRAP(P)1181 dated 8/5/2015, Proforma
Do you have documents
invoice #Q840886 dated 16/4/2015 and Sodium Hyaluronic Acid
confirming the import of
Q.No.3 reference standard (source: manufacturer) vide proforma invoice
reference standard and impurity
# 170317 dated 17/3/2017.
standards?
Regarding the impurities standards the firm has informed that for
Silver Sulphadiazine and Sodium Hyaluronic Acid the impurity
standards are unknown/not identified.
Do you have certificate of
Analysis of the API, reference
Q.No.4 Firm has certificate of analysis of API and reference standards.
standards and impurity
standards?
Do you have GMP certificate of Firm has provided copy of GMP certificate for Silver
API manufacturer issued by Sulphadiazine issued by AIFA Italian Medicine Agency and for
Q.No.5
regulatory authority of country Sodium Hyaluronic Acid GMP certificate issued by State institute
of origin? for drug control Czech Republic
The firm has informed that they used USP method (API
Do you use API manufacturer manufacturer method) for testing of Silver Sulphadiazine and in
Q.No.6 method of testing for testing house method for testing of Sodium Hyaluronic Acid through
API? HPLC. Manufacturer method of testing for Sodium Hyaluronic
Acid is through UV spectrophotometric method.
The firm has real time and accelerated stability study data sheets
provided by the API manufacturer.
Do you have stability studies It is pertinent to mention that a mistake regarding the storage
Q.No.7
reports on API? conditions was identified in stability data sheets for Sodium
Hyaluronic Acid, which the firm later clarified it as a
typographical mistake after confirmation from the manufacturer.
Q.No.8 If yes, whether the stability The stability studies have been performed as per SIM method.
testing has been performed as
per SIM method and
degradation products have been
quantified?
Q.No.9 Do you have method for Not Applicable
quantifying the impurities in the
API?
Do you have some remaining
quantities of the API, its The firm has record of remaining quantities of API, its reference
Q.No.10
reference standard and standard and impurities standard.
impurities standards?
Have you used pharmaceutical All excipients used in the formulation of Quench Plus cream were
Q.No.11
grade excipients? of pharmaceutical grade.
The firm has documents confirming the purchase of excipients
used in the formulation of Quench Plus Cream from local supplier.
Do you have documents
COAs were available.
Q.No.12 confirming the import of the
The firm informed that they have purchased these excipients from
used excipients?
local suppliers as small quantities of these materials cannot be
imported.
Do you have test reports and
The firm has complete testing records for the excipients used in
Q.No.13 other records on the excipients
the formulation.
used?
Do you have written and The firm has written and authorized protocols for the development
Q.No.14
authorized protocols for the of applied product.
development of applied
product?
Regarding the Drug-excipients compatibility studies, the firm has

informed that they have adopted formulation in accordance with
innovator, therefore not performed compatibility studies.
Have you performed Drug-
For innovator formulation the firm has provided a leaflet of
Q.No.15 excipients compatibility
innovator product wherein the name of all used excipients has
studies?
been mentioned, while the quantities used are in accordance with
limits identified in book of excipients (informed by the firm during
audit)
Have you performed
Q.No.16 comparative dissolution Not Applicable
studies?
Do you have product
Q.No.17 The firm has product development (R&D) section.
development (R&D) section
The firm has the necessary equipment in product development
Do you have necessary section.
equipments available in product Formulation of the product has been performed in R&D section
Q.No.18 development section for whereas filling of product into the tubes has been performed in
development of applied main production area.
product? The firm informed that filling of product in HDPE jar was
performed manually due to low batch size.
Q.No.19 Are the equipments in product The equipment used in the product development section was
development section qualified? qualified.
Do you have proper
maintenance / calibration / re- The firm has proper maintenance and calibration for the
Q.No.20
qualification program for the equipment used in product development.
equipment used in PD section?
Q.No.21 Do you have qualified staff in Firm has qualified staff with proper knowledge and training in
product development section product development.
with proper knowledge and
training in product
development?
The firm has manufactured three stability batches (in two type of
Have you manufactured three packaging i.e tube and jar) for the stability studies of Quench Plus
stability batches for the stability cream with the following batch No’s.
Q.No.22
studies of applied product as 1. PD17NO19
required? 2. PD17NO20
3. PD17NO21
Do you have any criteria for Firm has informed that a criterion for fixing batch size was based
Q.No.23 fixing the batch size of stability on their minimum requirements for stability samples used in
batches? stability studies.
Do you have complete record of The firm has complete batch manufacturing record of all the
Q.No.24
Do you have protocols for
Q.No.25 stability testing of stability Firm has protocols for stability testing of the stability batches.
batches?
Do you have developed and
The firm has developed and validated the method for the testing
Q.No.26 validated the method for testing
of stability batches.
of stability batches?
Q.No.27 Do you have method transfer Not Applicable
studies 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 Firm has all relevant documents confirming the qualification of
confirming the qualification of equipments/instruments used in the test and analysis of API and
equipments / instruments being the finished drug.
used in the test and analysis of
API and the finished drug?
Is your method of analysis The method of analysis used for analysis of stability batches was
Q.No.29
stability indicating? stability indicating.
Is your HPLC software is
Q.No.30 The HPLC software is 21CFR compliant.
21CFR compliant?
Q.No.31 Can you show Audit Trail Firm has demonstrated audit trail reports of testing.
reports on stability studies
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 The firm has remaining quantities of stability batches kept on
kept on stability testing? stability testing.
Do you have valid calibration
The firm has valid calibration status of the equipment used in
Q.No.34 status for the equipments used in
production and analysis of Quench Plus cream.
production and analysis?
Do proper and continuous The firm has stability chambers for carrying out accelerated and
Q.NO.35 monitoring and control are real time stability studies provided with uninterrupted power
available for stability chamber? supply and data loggers.
Do related manufacturing area,
equipment, personnel and Related manufacturing area, equipment, personnel and utilities are
Q.No.36
utilities be rated as GMP as per GMP compliance.
compliant?
Conclusion:
As per directions of Chairman Registration Board the constituted panel verified the tests of “Apparent viscosity”
and “Uniformity in Containers” during onsite inspection.
On risk-based approach the genuineness / authenticity of stability data submitted by the firm for registration of
Quench Plus Cream (Silver Sulfadiazine 100mg+ Sodium Hyaluronate 2mg) is verifiable to satisfactory level.
Decision: Registration Board decided to approve registration of “Quench Plus cream” of M/s Ferozsons
Labs, Amangarh, Nowshera. Manufacturer will place first three production batches of the product on long
term stability studies throughout proposed shelf life and on accelerated studies for six months
No. Manufacturer / (Proprietary Name + Initial Diary & Date, Availability / Local
Applicant Dosage Form + Strength), Fee (including Availability
Pharmacological Group, Demanded Price / GMP Inspection Report
Finished Product Pack size Date & Remarks
Specification
166. M/s Macter Empozin Tablet 10mg Form 5-D Jardiance tablet by M/s
International Ltd., F- Each film coated tablet Dy No. 7564 Boehringer (USFDA
216, S.I.T.E., contains: 05-07-2017 Approved)
Karachi Empagliflozin….10mg PKR 50,000/- Last GMP inspection
(Anti-diabetic) (4-7-2017) conducted on 12/10/2017
14’s: Rs. 7125/- concludes that the firm is
28’s: Rs. 15000/- complying the with good
level of GMP.
meeting of Registration Board. Details of submitted data are as under:
(Dy.# 9763 dated 15-03-2018)
Drug Empozin Tablet 10mg
Name of Manufacturer M/s Macter International Ltd., F-216, S.I.T.E., Karachi
Manufacturer of API M/s MSN Life Sciences private limited, Unit-II, Sy No. 455/A, 455/AA, 455/E
and 455/EE, Chandampet Village, Shankarampet-R Mandal District, Telangana
India
API Lot No. EMPG/E411/6D/01
Description of Pack
Alu-Alu blister 2 x 14’s
Frequency Accelerated: 0, 1, 3, 6 (Months)
Real Time: 0, 1, 3, 6, 9 (Months)
Batch No. 001P 002P 003P
Manufacturing Date May 2017 May 2017 May 2017
No. of Batches 03
1. COA of API Firm has provided certificate of analysis of
Empagliflozin of lot No. EMPG/E411/6D/01
2. Approval of API by regulatory authority of Firm has submitted copy of GMP certificate (No.
country of origin or GMP certificate of API L.Dis.No.3834/E(S)/TS/2016) issued by Drug Control
manufacturer issued by regulatory authority of administration Telangana. The certificate is valid till 02-
country of origin. 03-2018.
Firm has also submitted copy of request letter for renewal
of GMP certificate by the manufacturer dated 21-02-
2018. The license status of the firm has been verified
online from
http://odls.telangana.gov.in/ThirdPartypublicview.aspx
(Accessed 20-4-2018).
Yes
4. Data of 03 batches will be supported by attested Firm has provided data of 3 batches supported by
respective documents like chromatograms, attested documents like chromatograms and raw data
laboratory reports, data sheets etc. sheets.
5. Documents confirming import of API etc. Firm has provided ADC attested copy of invoice
confirming import of 2Kg empagliflozin along with
working standard and impurities.
data / documents.
Yes
Yes
Rules, 1978.
 The documents for import of API do not contain details regarding batch number, manufacturing or expiry
date of the imported API.
 Firm has used same batch numbers for both 10 and 25mg strength.
167. Applicant Dosage Form + Strength), Fee (including Availability
Specification
1. M/s Macter Empozin Tablet 25mg Form 5-D Jardiance tablet by M/s
International Ltd., F- Each film coated tablet Dy No. 7563 Boehringer (USFDA
216, S.I.T.E., contains: 05-07-2017 Approved)
Karachi Empagliflozin….25mg PKR 50,000/- Last GMP inspection
(Anti-diabetic) (4-7-2017) conducted on 12/10/2017
14’s: Rs. 7125/- concludes that the firm is
28’s: Rs. 15000/- complying the with good
level of GMP.
meeting of Registration Board. Details of submitted data are as under:
(Dy.# 9762 dated 15-03-2018)
Drug Empozin Tablet 25mg
Name of Manufacturer M/s Macter International Ltd., F-216, S.I.T.E., Karachi
Manufacturer of API M/s MSN Life Sciences private limited, Unit-II, Sy No. 455/A, 455/AA, 455/E
and 455/EE, Chandampet Village, Shankarampet-R Mandal District, Telangana
India
API Lot No. EMPG/E411/6D/01
Description of Pack
Alu-Alu blister 2 x 14’s
Frequency Accelerated: 0, 1, 3, 6 (Months)
Real Time: 0, 1, 3, 6, 9 (Months)
Manufacturing Date May 2017 May 2017 May 2017
No. of Batches 03
1. COA of API Firm has provided certificate of analysis of
Empagliflozin of lot No. EMPG/E411/6D/01
2. Approval of API by regulatory authority of Firm has submitted copy of GMP certificate (No.
country of origin or GMP certificate of API L.Dis.No.3834/E(S)/TS/2016) issued by Drug Control
manufacturer issued by regulatory authority of administration Telangana. The certificate is valid till 02-
country of origin. 03-2018.
Firm has also submitted copy of request letter for renewal
of GMP certificate by the manufacturer dated 21-02-
2018. The license status of the firm has been verified
online from
http://odls.telangana.gov.in/ThirdPartypublicview.aspx
(Accessed 20-4-2018).
Yes
4. Data of 03 batches will be supported by attested Firm has provided data of 3 batches supported by
respective documents like chromatograms, attested documents like chromatograms and raw data
laboratory reports, data sheets etc. sheets.
5. Documents confirming import of API etc. Firm has provided ADC attested copy of invoice
confirming import of 2Kg empagliflozin along with
working standard and impurities.
data / documents.
Yes
Yes
Rules, 1978.
 The documents for import of API do not contain details regarding batch number, manufacturing or expiry
date of the imported API.
 Firm has used same batch numbers for both 10 and 25mg strength.
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Empozin 10mg
and Empozin 25mg (Empagliflozin) Tablets by M/s. Macter International Ltd., F-216, S.I.T.E, Karachi.

Investigation Date and Time: 20th June, 2018. (Morning).
Investigation Site: M/s. Macter International Ltd., F-216, S.I.T.E, Karachi.
Background:
Registration Board meeting considered the applications of M/s. Macter International Ltd., F-216, S.I.T.E,
Karachi for registration of Empozin 10mg and Empozin 25mg (Empagliflozin) 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 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.
3. Dr. Rafeeq Alam Khan, Meritorious Professor and Chairman, Department of Pharmacology, University
of Karachi. (Member Registration Board)

Detail of Investigation:
S. No. Question Observation
1. Do you have documents confirming the The firm has imported 2KG Empagliflozin (API) from MSN
import of Empagliflozin API including Life Sciences, India vide invoice No. 44323 dated:
approval from DRAP? 21.04.2017. There is proper approval from DRAP Karachi.
2. What was the rationale behind selectingThe rationale behind selecting the particular manufacturer of
the particular manufacturer of API? API is the vendor evaluation process based on audit and other
criterias like manufacturer GMP status, DMF source etc.
3. Do you have documents confirming the The firm has imported Empagliflozin working standard and
import of Empagliflozin reference two impurity standards from the API manufacturer.
standard and impurity standards?
4. Do you have certificate of Analysis of The firm has Certificate of Analysis of API, working
the API, reference standards and standard of API and impurities standards.
impurity standards?
5. Do you have GMP certificate of API The firm has GMP certificates for API manufacturer issued
manufacturer issued by regulatory by Deputy Director & Certifying Authority, Drugs Control
authority of country of origin? Administration, Govt. of Telangana, India.
6. Do you use API manufacturer method The firm has used API manufacturer method of testing.
of testing for testing API?
7. Do you have stability studies reports on The firm has stability studies report on API (Empagliflozin)
APIs? conducted by API manufacturer.
8. If yes, whether the stability testing has The manufacturer of API has performed the stability studies
been performed as per SIM method and as per SIM method. The process related impurities have been
degradation products have been quantified, however, no degradation product has been
quantified? observed.
9. Do you have method for quantifying the The firm has method for quantifying impurities (Process
impurities in the API? related).
10. Do you have some remaining quantities The firm has some remaining quantities of API
of the API, its reference standard and (Empagliflozin) working standard and impurity standard.
11. Have you used pharmaceutical grade The firm has used pharmaceutical grade excipients including
excipients? Lactose monohydrate, Microcrystalline cellulose,
Hydroxypropyl cellulose, Croscarmellose sodium, Colloidal
anhydrous silica and Magnesium stearate.
12. Do you have documents confirming the The firm has necessary documents confirming the import of
import of the used excipients? the used excipients.
13. Do you have test reports and other The firm has test reports and other records for the excipients
14. Do you have written and authorized The firm has written and authorized protocol for the
protocols for the development of development of Empagliflozin 10mg and 25mg tablets.
Empagliflozin Tablets?
15. Have you performed Drug-excipient
The firm has not performed Drug Excipient compatibility
compatibility studies? studies as composition of their product is similar to that of
innovator product (Jardiance Tablets, Boehringer Ingelheim,
Germany).
16. Have you performed comparative The firm has perform comparative dissolution profile of their
dissolution studies? 10mg and 25mg tablets against 10mg and 25mg tablets of the
innovator. The firm tablets show comparable dissolution
profile with date of the innovator tablets.
17. Do you have product development The firm has product development (R&D) section with
(R&D) section requisite manufacturing, storage and analysis facilities.
18. Do you have necessary equipments The firm has all the necessary equipment available in product
available in product development development section for the development of Empagliflozin
section for development of tablets.
Empagliflozin Tablets?
19. Are the equipment in product The equipments in product development section are
20. Do you have proper maintenance / The firm has proper maintenance / calibration / re-
calibration / re-qualification program qualification program for the equipment used in PD section.
for the equipment used in PD section?
21. Do you have qualified staff in product The firm has qualified staff in PD section with proper
development section with proper knowledge and training in Product Development including
knowledge and training in product 01 Ph.D., 02 Pharmacists and 04 MSc Chemistry.
development?
22. Have you manufactured three stability The firm has manufactured three stability batches as follows;
batches for the stability studies of Empagliflozin 10mg tablets:
Empagliflozin Tablets required? Sr. No. B. No. Batch size
1 001P 4,000
2 002P 4,000
3 003P 4,000
Empagliflozin 25mg tablets:

Sr. No. B. No. Batch size
1 001P 5,000
2 002P 5,000
3 003P 5,000
The tablets are packed in Alu Alu blisters with pack size 14s
for both potencies.
23. Do you have any criteria for fixing the The criteria for fixing the batch size of stability batches is the
batch size of stability batches? number of tablets required per testing frequency and number
of testing frequencies.
24. Do you have complete record of The firm has complete records of production of stability
production of stability batches? batches. All log books are properly maintained.
25. Do you have protocols for stability The firm has detailed protocol for the stability testing of
testing of stability batches? Empagliflozin tablets.
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 of finish product i.e. Empagliflozin tablets
batches? based on the API method of testing provided by the API
manufacturer.
27. Do you have method transfer studies in The firm has developed and validated method based on API
case when the method of testing being manufacturer for testing of finished product.
lab?
28. Do you have documents confirming the The firm has proper documents confirming the qualification
qualification of equipment / instruments of equipment / instruments being used in the test and analysis
being used in the test and analysis of of the API (Empagliflozin) and the finished drug Empozin
Empagliflozin and the finished drug? (Empagliflozin) tablets.
29. Do your method of analysis stability The firm method of analysis is stability indicating as
indicating? evidence by forced degradation studies and spiking studies
of the two major impurities. Both the impurities are process
related and the forced degradation studies also confirmed that
there is no degradation product.
30. Do your HPLC software 21CFR The HPLC software is 21CFR compliant as per record of the
Compliant? firm.
31. Can you show Audit trail reports on Audit Trail on the testing reports on Empagliflozin API and
Empagliflozin testing? Empozin tablets is available.
32. Do you have some remaining quantities The firm has only remaining quantities of stability batches
of degradation products and stability kept on real-time stability testing.
batches?
33. Do you have stability batches kept on The firm has three lab scale batches kept on stability studies
stability testing? for real time stability testing. Currently 12 months studies
have been completed with satisfactory results.
34. Do you have valid calibration status for The firm has valid calibration status for the equipment used
the equipment used in Empagliflozin in Empozin (Empagliflozin) tablets production and analysis.
Tablets production and analysis?
35. Do proper and continuous monitoring The firm has adequate monitoring and control system for
and control are available for stability stability chambers.
chamber?
36. Do related manufacturing area, The related manufacturing area, equipments, personnel and
equipment, personnel and utilities be utilities are GMP compliant.
37. Any observation / query by the PEC? i. Although there is no detail of the API on the invoice
i. The document for import of API with regard to its batch number, manufacturing date
do not contain details regarding and expiry date, however, all these informations are
batch number, manufacturing or provided in the related certificate of analysis of the
expiry date of the imported API. API. The invoice can be cross-referenced to Form-3
which is also an important import document.
Moreover, the label of the container of the API
contains the same batch number as mentioned on the
CoA of the API.
ii. The BMRs of all the batches (3+3) clearly show that
firm has used the API of the same lot number for
ii. Firm has used same batch production of their three batches of 10mg tablets and
numbers for both 10 and 25mg three batches of 25mg tablets. Around 120g API has
strength of finished drugs. been used in production of 10mg tablets, whereas
375g API in production of 25mg tablets.
Conclusions:
1. On the basis of risk based approach the genuineness / authenticity of stability data submitted by the firm
for registration of Empozin 10mg and Empozin 25mg (Empagliflozin) Tablets is verifiable satisfactory
level.
2. The related manufacturing area, equipments, personnel and utilities are GMP compliant and well suited
for the manufacturing of Empozin 10mg and Empozin 25mg (Empagliflozin) Tablets, hence registration
of Empozin 10mg and Empozin 25mg tablets is recommended.
Decision: Registration Board decided to approve registration of “Empozin Tablet 10mg (Empagliflozin
10mg) and Empozin Tablet 25mg (Empagliflozin 25mg) by M/s Macter International Ltd., F-216, S.I.T.E.,
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.
Specification
168. M/s Pharmevo (Pvt) Sovelpa 400/100mg tablet Form 5-D Epclusa tablet by Gilead
Ltd., Plot # A-29, Each film coated tablet: Dy No. 11645 sciences Inc (USFDA
North Western Sofosbuvir…….400mg 30-03-2018 Approved)
Industrial zone, Port Velpatasvir…..100mg PKR 50,000/-
Qasim, Karachi. (30-03-2018) Last inspection dated 23-
7’s, 14’s, 28’s: As per 02-2018 confirms that the
SRO firm is operating at an
acceptable level of GMP
compliance
Evaluation by PEC:
Firm has submitted accelerated and real time stability data of 6 months as per the requirement of
Registration Board.
Drug Sovelpa 400/100mg Tablet
Name of Manufacturer M/s Pharmevo (Pvt) Ltd., Plot # A-29, North Western Industrial zone, Port
Qasim, Karachi.
Manufacturer of API Sofosbuvir: Ruyuan HEC Pharm, China
Velpatasvir: Ruyuan HEC Pharm, China
API Lot No. Sofosbuvir: S104B-201704201
Velpatasvir: VEPII-201707002
Description of Pack
Alu-Alu foil in printed unit carton
Frequency Accelerated: 0, 3, 6 (Months)
Real Time: 0, 3, 6 (Months)
Batch No. 17PD-216013-T 17PD-2161-14-T 17PD-2162-15-T
Manufacturing Date Sep-2017 Sep-2017 Sep-2017
No. of Batches 03
1. COA of API
Yes
2. Approval of API by regulatory authority of Copy of GMP certificate issued by Shaoguan food and
country of origin or GMP certificate of API Drug Administration has been submitted for M/s Ruyuan
manufacturer issued by regulatory authority of HEC Pharm Co., Ltd. The certificate is valid
country of origin. upto 12-12-2018.
GMP Inspection of M/s Ruyuan HEC Pharm. Co., Ltd.
Shaoguan City, China dated 09/11/15 by CDER (US
FDA) classified as NAI (No Action Indicated).
Yes
5. Documents confirming import of API etc. Sofosbuvir: Firm has submitted ADC attested invoice
dated 22-6-2017, confirming import of Sofosbuvir from
WIS Pharmatech Co. Ltd.manufactured by Ruyuan HEC
Pharm Co.
Velpatasvir: Firm has submitted ADC attested invoice
dated 07-08-2017, confirming import of Sofosbuvir from
WIS Pharmatech Co. Ltd.manufactured by Ruyuan HEC
Pharm Co.
data / documents.
Yes
Yes
Rules, 1978.
 The panel may be requested to report the details of reference standard (nomenclature, physical form, source,
molecular formula and molecular mass) of velptasvir used in the analysis of applied formulation.
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Sovelpa
400mg/100mg (Sofosbuvir/Velpatasvir) Tablets by M/s. Pharmevo (Pvt) Ltd., Karachi.

Background:
Chairman registration has approved the following panel for onsite investigation to confirm genuineness
and/authenticity of stability data and associated documents, import of API, quality, specification, test analysis,
facilities etc. It was also advised to verify the following point:
 The details of reference standard (nomenclature, physical form, source, molecular formula and molecular
mass) of velpatasvir used in the analysis of applied formulation be reported.

M/s. PharmEvo (Pvt) Ltd., Karachi. –

Sovelpa (Sofosbuvir / Velpatasvir) 400/100mg Tablets

1. Do you have documents confirming the The firm has imported 2Kg of Velpatasvir (as
Import of Sofosbuvir and Velpatasvir APIs copovidone solid dispersion) from M/S Ruyuan
including approval from DRAP? HEC China for the manufacturing of lab scale
batches of SOVELPA 400/100mg Tablets. The
sof osbuvi r AP I has been used f r o m
commer ci al l ot of 200Kg i mported the
same manufacturer . There is proper approval for
the import of both APIs from DRAP, Karachi.
2. What was the rationale behind selecting The rationale behind selecting the particular source
the particular manufacturer of APIs? of APIs is the laid down criteria of the firm in their
Vendor Evaluation procedure which include the
GMP status of the firm, DMF source and capability
to provide APIs reference standard and impurity
standard.
3. Do you have documents confirming the Firm has documents confirming the import of
import of Sofosbuvir and Velpatasvir Sofosbuvir and Velpatasvir working standards and
reference standards and impurity impurities standards.
standards?
4. Do you have certificate of Analysis of the The firm has certificates of analysis for APIs,
APIs, reference standards and Working standards of the APIs and 05 impurities
impurity standards? standards of Sofosbuvir and 01 major impurity of
Velpatasvir.
5. Do you have GMP certificate of APIs Firm h a s copy of GMP certificates of APIs issued
manufacturer issued by regulatory by the country of origin of manufacturer (from
authority of country of origin? Shaoguan FDA)
6. Do you use APIs manufacturer’s The firm has APIs manufacturer methods for
methods of testing for testing APIs? testing the APIs.
7. Do you have stability studies reports on The firm has stability studies reports on both APIs.
APIs?
been performed as per SIM method and methods and degradation products have been
degradation products have been quantified.
quantified?
9. Do you have method for quantifying the The firm has APIs manufacturer methods for
impurities in the APIs? quantifying the impurities in the APIs.
10. Do you have some remaining quantities of Firm has some quantities of the APIs, working
the API, its reference standard and standards of the APIs and Impurities working
impurities standards? standards.
excipients? which include microcrystalline cellulose ph.102,
Croscarmellose Sodium, Magnesium Stearate.
protocols for the development of the development of SOVELPA 400/100mg Tablets
SOVELPA 400/100mg Tablets
(Sofosbuvir+Velpatasvir) Tablets ?
15. Have you performed Drug-excipient The firm has not performed Drug-excipient-
compatibility studies? compatibility studies as the composition of their
tablets is similar to that of the innovator product
(Epclusa Tablets of Gilead Sciences USA).
16. Have you performed comparative The firm has performed comparative dissolution
dissolution studies? studies with a comparator product (Velpanat Tablets)
manufactured by Natco Pharma India. The firm’s
product has comparable dissolution profile with the
comparator product however it would be better to
perform the study against the innovator product as
velpatasvir is BCS class IV API.
17. Do you have product development (R&D) The firm has dedicated R&D section with
section? reasonable facilities of equipments, human resource
and utilities. Some other new equipment like
compression machine, mixer / granulator and FB
dryer and lab scale china coata have been
procured.
18. Do you have necessary equipments The firm has all necessary equipments related to
available in product development section manufacturing available in R&D section for
for development of Sovelpa tablets? manufacturing of Sovelpa Tablets. Firm has added
some new manufacturing equipment in the existing
list of equipments as mentioned above. The quality
control related to development work has been done in
the routine quality control laboratory; however, there
are dedicated HPLCs and Human Resource for this
purpose.
19. Are the equipments in product All the equipments used in product development
20. Do you have proper maintenance / The firm has proper maintenance / calibration
calibration / re-qualification program for programme. Re-qualification program for the
the equipment used in PD section? equipment used in PD section as needed.
development section with proper manufacturing section of product development
knowledge and training in product section currently with suitable knowledge and
development? training in product
22. Have you manufactured three stability The firm has manufactured three stability batches
batches for the stability studies of for the stability studies of: Sovelpa 400/100mg
Sovelpa tablets as required? Tablets with Batch Number:
17PD-2160-13-T, 17PD-2161-14-T, 17PD-2162-
15-T each of 2500 tablets respectively. The tablets
are packed in Alu / Alu blisters with pack size of
4x7’s. The manufacturing process is dry
granulation.
24. Do you have complete record of The firm has complete record of production of
25. Do you have protocols for stability testing The firm has detailed protocols for stability testing
26. Do you have developed and validated the Firm has developed and validated the method for
method for testing of stability batches? testing their finished product. The method is stability
indicating as evident by the forced degradation study
and impurities spiking study. This method has been
developed and validated however after 03 months of
production of stability batches hence applied to 06
months and onward stability testing.
27. Do you have method transfer studies in Not Applicable.
lab?
28. Do you have documents confirming the The firm has documents confirming the installation
qualification of equipments / instruments and operational qualification of the equipment /
being used in the test and analysis of instruments being used in the test and analysis of
Sofosbuvir and Velpatasvir and the finished Sofosbuvir and Velpatasvir and the finished drug.
drug?
29. Do your method of analysis stability Firm has used two different methods for testing of
indicating? stability batches. The first method is an isocratic
method used for testing of stability batches up to
03months testing and this method is not stability
indicating. A second method has been developed,
validated and used for 06 months study of stability
batches kept on real time and accelerated stability
testing. This method is gradient method and is
stability indicating and properly validated and
supported by forced degradation and spiking studies.
30. Do your HPLC software 21CFR The HPLC software is 21CFR Compliant as per
Compliant? record available with the firm.
31. Can you show Audit trail reports on Audit trail on the testing reports are available.
Sofosbuvir+Velpatasvir and finished
product testing?
32. Do you have some remaining quantities of The firm has remaining quantities of the main
degradation products and stability batches? degradation products a n d t h e finished product.
33. Do you have stability batches kept on The firm has kept all the three batches on real
stability testing? time and accelerated stability testing. The
accelerated studies has been completed whereas real
time studies are underway. Currently, 06 months
studies have been completed with satisfactory
results.
34. Do you have valid calibration status for theThe firm has valid calibration status for the
equipments used in S o v e l p a tablets equipment used in Sovelpa tablets production and
production and analysis? analysis.
35. Do proper and continuous monitoring and The firm has 12 stability chambers, 02 for
control are available for stability chamber?accelerated and 10 for real time stability testing. All
the chambers are properly qualified. All the
chambers are provided with continuous power
supply and data loggers for continuous monitoring.
The batches in question have been kept in stability
chamber No.6. The data of data loggers is reviewed
every 15th day.
36. Do related manufacturing area, equipment, The firm has manufacturing area provided with
personnel and utilities be rated as GMP necessary qualified equipments and utilities. The
compliant? manufacturing personnel are suitable in number
and qualification to run the manufacturing
processes as per GMP requirements. The
environmental conditions and their controls are also
proper. The overall GMP conditions can be rated as
compliant.
37. Any query/observation by PEC: Around 100mg working standard of the API with
The details of reference standard Batch NO.VEP-201601001 manufacturing date
(nomenclature, physical form, source, 15/01/2016, of 99.9% purity has been imported
molecular formula and molecular mass) of from M/s Ruyuan HEC China for initial testing of
velpatasvir used in the analysis of applied the API (i.e. Velpatasvir copovidone solid
formulation be reported. dispersion). Further testing studies have been based
on the API. The firm is advised to import
immediately the reference standard of velpatasvir
and must analyze the stability batches while using
the reference standard in the upcoming studies.
Conclusion:
3) On the basis of risk based approach the genuineness/authenticity of the stability data submitted
by the firm for the registration of Sovelpa 400/100mg Tablets are verifiable to satisfactory level.
4) The related manufacturing area, equipment, personnel and utilities are GMP compliant and well-
suited for the manufacturing of Sovelpa 400/100mg Tablets. Therefore the panel recommends the
registration of Sovelpa 400/100mg Tablets in the name of manufacturer.
5) Since Velpatasvir falls in BCS class IV therefore BE studies are required for any combination
product containing velpatasvir as per WHO and other standards. The panel also recommends
post registration BE studies for Sovelpa Tablets.
NOTE: It is submitted that the firm has submitted an Undertaking dated 22nd June 2018 for the same (copy
enclosed).
Decision: Registration Board decided to approve registration of “Sovelpa 400/100mg tablet (Sofosbuvir
400mg / Velpatasvir 100mg” by M/s Pharmevo (Pvt) Ltd., Plot # A-29, North Western Industrial zone, Port
Qasim, Karachi. Manufacturer will place first three production batches of the product on long term
stability studies throughout proposed shelf life and on accelerated studies for six months.
No. Manufacturer / (Proprietary Name Initial Diary & Date, Fee Availability / Local
Applicant + Dosage Form + (including differential fee), Availability
Strength), Demanded Price / Pack size
Composition, GMP Inspection
Pharmacological Report Date &
Group, Remarks
Finished Product
Specification
169. M/s OBS Pakistan Glifoza 5 mg tablet Form-5-D Farxiga of Astrazeneca
(Pvt.) Ltd. C-14, Each film coated Dy. No: 758 USFDA Approved.
S.I.T.E, Karachi tablet contains: Dated.2-11-2015 GMP inspection report
Pakistan Dapagliflozin Rs.50,000/- (29-10-2015) conducted on Last
propanediol 10’s ; Rs. 3400/- inspection was
monohydrate eq to 14’s; Rs. 4760/- conducted on 11.04.2017
dapagliflozin….5mg with no observation
(Anti Diabetic)
sodium-glucose co-
transporter 2
(SGLT2) inhibitors
Drug Glifoza 5 mg tablet
Name of Manufacturer M/s OBS Pakistan (Pvt.) Ltd. C-14, S.I.T.E, Karachi Pakistan
Manufacturer of API Dapagliflozin propanediol monohydrate: MSN Laboratories Pvt.Ltd.
Sy.No 317 & 323, Rudraram (village), Patancheru (Mandal), Medak District,
Telangana India.
API Lot No. Dapagliflozin propanediol monohydrate: DQ0010217
Description of Pack
Al foil 1x10x2
Accelerated:6 months
Batch No. 044DS01 044DS02 044DS03
Manufacturing Date May-2017 May 2017 May 2017

Date of Initiation June-2017 June-2017 June-2017
No. of Batches 03
No.
1. COA of API
Yes
2. 0 Approval of API by regulatory authority of Dapagliflozin: Copy of GMP certificate issued to MSN
country of origin or GMP certificate of API Laboratories Pvt.Ltd. Sy.No 317 & 323, Rudraram
manufacturer issued by regulatory authority of (village), Patancheru (Mandal), Medak District, Telangana
country of origin. India., valid upto 2 year. The said certificate has been
verified from following website link when accessed on 30-
3-2018:
http://dca.telangana.gov.in/content.php?U=7
Yes
Yes
etc.
5. Documents confirming import of API etc. Dapagliflozin: Copy of commercial invoice has been
submitted issued by ADC, Karachi DRAP.
Yes
Yes
Rules, 1978.
 In master formulation active ingredient is mentioned as monohydrate form while in invoice it’s just as
Dapagliflozin Propanediol. Clarify the following.
 In address district is mentioned as Medak but in GMP it is mentioned as Sangaroddy district
Specification
170. M/s OBS Pakistan Glifoza 10mg Tablet Form 5-D Farxiga tablets by
(Pvt) Ltd. C-14, Each film coated tablet 21-11-2015 Astrazeneca (USFDA
S.I.T.E., Karachi, contains: PKR 50,000/- Approved)
Pakistan Dapagliflozin propanediol 2-11-2015
monohydrate eq to (DUPLICATE) 11-4-17: Good
dapagliflozin……….10mg 10’s: Rs. 6,000/- cGMP compliance
14’s: Rs. 8400/-
(As per SRO)
(Dy.# 8302 dated 06-03-2018)
Drug Glifoza 10mg Tablet
Name of Manufacturer M/s OBS Pakistan (Pvt) Ltd. C-14, S.I.T.E., Karachi, Pakistan
Manufacturer of API MSN Laboratories (Pvt) Ltd., Sy No. 317 & 323 Rudraram, Patancheru, Medak
District Telangana, India
API Lot No. DQ0010217
Description of Pack
1 x 7’s x 2: Alu-Alu blister pack
Frequency Accelerated: 0, 3, 6 (Months)
Real Time: 0, 3, 6 (Months)
Batch No. 045DS01 045DS02 045DS03
Manufacturing Date July 2017 July 2017 July 2017
Date of Initiation 8 Aug 2017 8 Aug 2017 8 Aug 2017
No. of Batches 03
1. COA of API
Firm has submitted COA of batch DQ0010217

GMP certificate of M/s MSN Laboratories (Pvt) Ltd.,
issued by Drugs Control Administration, Government of
Telangana dated 16-10-2017 is provided.
country of origin.
Yes
5. Documents confirming import of API etc. Firm has submitted ADC attested commercial invoice
dated 29-03-2017 confirming import of 0.5Kg
Dapagliflozin propanediol from M/s MSN Laboratories
data / documents.
Yes
Yes
Rules, 1978.
 The address of exporting firm in commercial invoice is MSN Laboratories (Pvt) Ltd., Sy No. 317 & 323
Rudraram, Patancheru, Medak District Telangana, India, while the address of the firm in submitted GMP is
MSN Laboratories (Pvt) Ltd., Sy No. 317 & 323 Rudraram, Patancheru, Sangareddy District Telangana, India
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Glifoza
(Dapagliflozin) 5mg & 10mg Tablets by M/s OBS Pakistan Pvt. Limited, C-14, Manghopir Road, S.I.T.E,
Karachi.
Reference No: F.13-11/2017-PEC dated 20th June, 2018.

Investigation Date and Time: 22nd June, 2018. (Forenoon)
Investigation Site: Factory premises of M/s OBS Pakistan Pvt. Limited, C-14, Manghopir Road, S.I.T.E,
Karachi.
Background:
Chairman Registration Board considered the applications of M/s OBS Pakistan Pvt. Limited, C-14,
Manghopir Road, S.I.T.E, Karachi for registration of Glifoza (Dapagliflozin) 5mg & 10mg 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. The
panel was also advised to verify the following point:
“Verify the difference in address of API manufacturer mentioned in the commercial invoice while the
firm has submitted a letter dated 14-02-17 of API manufacturer i.e. stating that the name of district in address of
MSN Laboratories has been changed from Medak to Sangareddy according to Telangana Re Organization Act,
Act 7 of 1974 formation of new district, Revenue division and mandals. The commercial invoice which was
generated and cleared after the above stated letter again contain the name of Medak district. This create doubt that
since API has been imported after change of district or otherwise”.
1. Dr. Rafeeq Alam Khan, Meritorious Professor and Chairman, Department of Pharmacology, University
of Karachi. (Member Registration Board)
2. Syed Muzaffar Ali Jafri, Director DTL Sindh, Karachi (Member Registration Board)
3. Dr. Affan Ali Qureshi, Assistant Director, CDL, DRAP, Karachi.

Glifoza 5mg & 10mg Tablets (Dapagliflozin)
Q. NO. QUESTION OBSERVATION BY PANEL
1. Do you have documents confirming the Firm has imported 0.5 kg Dapagliflozin from M/s. MSN
import of API including approval from Laboratories (Pvt.) limited, India, having Batch number
DRAP? DQ0010217 vide Invoice No. 1500500997/16-17 dated
08-03-2017
2. What was the rationale behind selecting Selection of the manufacturer has been based upon its
the particular manufacturer of API? GMP Certification, DMF availability, desktop audit &
vendor qualification questionnaire.
3. Do you have documents confirming the The firm has imported working standards & impurity
import of reference standard and standard of API.
impurity standards?
4. Do you have certificate of analysis of The firm has certificate of analysis for API its Working
API, reference standards and impurity standards & impurity standards.
standards
5. Do you have GMP certificate of API The firm has GMP certificate of API Manufacturer issued
manufacturer issued by regulatory by Drug Control administration, government of
authority of country of origin? Telangana.
6. Do you use API manufacturer method The firm is using validated API manufacturer method for
of the testing for testing API? testing of API.
7. Do you have stability studies report on The firm has stability study reports on API.
API?
been performed as per SIM and method and degradation products have been quantified.
quantified?
9. Do you have methods for quantifying The firm has method for quantifying the impurities in the
the impurities in API? API.
10. Do you have some remaining quantities The firm has remaining quantities of the API & working
of API, the reference standards and standard & impurity standards of API.
impurities?
excepients? including: Microcrystalline cellulose, Lactose
Anhydrous, Crosspovidone, Magnesium stearate,
Colloidal silicon dioxide, Sheffcoat PVA, Yellow ferric
oxide, Talc.
12. Do you have documents confirming the The firm has necessary documents confirming the import
import of used excepients? of used excepients.
13. Do you have test reports and other The firm has test reports & other record on the used
records on the excepients used excepients.
14. Do you have written and authorized The firm has written and authorized protocols for the
protocols for the development of development of Glifoza (Dapagliflozin) Tablets 5mg &
products? 10mg
15. Have you performed drug-excepient The firm has not performed Drug-Excepients
compatibility studies? compatibility studies as their formulation is similar to that
of the innovator.
16. Have you performed comparative The firm has performed comparative dissolution study of
dissolution studies? product against the innovator Forxiga Tablets
manufactured by M/s. AstraZeneca Pharmaceutical, UK.
More than 85% dissolved in 15 minutes for both
innovator & test product.
17. Do you have product development The firm has dedicated area for product development
(R&D) 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 batches in product development section.
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 requalification program for the equipments used in
the equipment used in P&D section? product development section.
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 The firm has manufactured three stability batches for the
batches for the stability studies of the stability studies with following details:
product as required? Batch # Mfg date Batch size
Glifoza Tablets 5mg
044DS01 May-2017 2500 Tabs
044DS02 May-2017 2500 Tabs
044DS03 May-2017 2500 Tabs
Glifoza Tablets 10mg
045DS01 Jul-2017 2500 Tabs
045DS02 Jul-2017 2500 Tabs
045DS03 Jul-2017 2500 Tabs
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 tablets
required per testing and number of testing frequencies.
24. Do you have complete record of The firm has complete record of production of stability
production of stability batches? batches. Necessary log book of equipment used have
been available with the firm, assuring the traceability of
manufacturing and analyses of stability batches.
25. Do you have protocols for stability The firm has protocols for stability testing of Stability
testing of stability products? batches.
26. Do you have developed and validated The method used for testing stability batches of the
the method for testing of stability finished product is stability indicating and has been
batches? validated using the working standard of API and also
supported by forced degradation studies.
27. Do you have method transfer studies in The firm has developed & validated their own method of
case when the method of testing used by testing on the basis of API manufacturer’s method of
your firm is given by another firm? testing. Therefore no transfer studies are required.
28. Do you have documents confirming the The firm has proper documents confirming the
qualification of equipment/instruments qualification of equipment / instruments being used in the
being used in the test and analysis of test and analysis of API and finished products.
API and the finished products?
29. Do your method of analysis stability The method of testing is stability indicating for stability
indicating? test of the 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 was initially not activated. However, now
product testing? audit trail is activated and reports are available from 9
months & onwards for real time.
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.
batches?
33. Do you have stability batches kept on The firm has completed the accelerated stability testing
stability testing? on the three stability batches of Glifoza (Dapagliflozin)
Tablets 5mg & 10mg. Real time stability study is in
progress on all three stability batches of both the
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.
analysis?
35. Do proper and continuous monitoring Continuous power supply and monitoring (data loggers)
and control are available for stability are available for stability chambers. The data is properly
chamber? reviewed on daily basis.
36. Do related manufacturing area, The related manufacturing area, equipment and utilities
equipment, personnel, and utilities be cannot be rated as GMP compliant. The main
rated as GMP compliant? 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.
Other Utilities also need up gradation to comply GMP
regulations.
37. Verify the difference in address of API The panel reviewed the letters from the API
manufacturer mentioned in the manufacturer, the official gazette of Government of
commercial invoice while the firm has Telangana, and other related documents, which have
submitted a letter dated 14-02-17 of common address other than name of district, and have
API manufacturer i.e. stating that the same area code for their telephone numbers. The panel
name of district in address of MSN concluded that the difference of address on commercial
Laboratories has been changed from invoice is just a delay in system update, otherwise the
Medak to Sangareddy according to API is imported from the same source.
Telangana Re Organization Act, Act 7
of 1974 formation of new district,
Revenue division and mandals. The
commercial invoice which was
generated and cleared after the above
stated letter again contain the name of
Medak district. This create doubt that
since API has been imported after
change of district or otherwise
CONCLUSION:
1. On the basis of risk based approach the genuineness/authenticity of stability data submitted by the
firm for registration of Glifoza (Dapagliflozin) 5mg & 10mg 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 Glifoza (Dapagliflozin) 5mg & 10mg Tablets.
3. The panel recommends the following improvements to comply with cGMP standards:
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.
4. However, the firm has started the improvement work and ordered the necessary equipment which
are expected to be delivered and installed by December 2018, as per the record/purchase orders
available with the firm.
5. Keeping in view the above statement the panel recommends grant of registration only if the firm
agrees not to manufacture commercial batches of above-mentioned products before the area is
improved as per cGMP standards & the recommendation of the panel.
Decision: Registration Board decided to defer above case for GMP assessment after renovation of tablet
section. Two members panel will evaluate GMP status of tablet section after information by the firm.
Sr. Name & Address Brand Name Type of Form, International Remarks of
No. of Manufacturer / (Proprietary Name + Initial Diary & Availability / Local the Evaluator
Applicant Dosage Form + Date, Fee Availability
Strength), Composition, (including
Pharmacological Group, differential fee), GMP Inspection
Finished Product Demanded Price / Report Date &
Specification Pack size Remarks
171. M/s. OBS Pakistan Etoricoxib 30mg Tablet Form-5D Arcoxia 30mg tablet
Ltd, C-14, (Brands proposed in Duplicate, 20-01- of MSD, MHRA
Manghopir Road, priority order: Arkoxit, 2017
SITE, Karachi Arxeto, Etoxi) Rs. 50,000/-, 06-
Each film coated tablet 01-2017
contains: 7’s, 14’s, & 28’s ;
Etoricoxib…..…….30mg As per DPC
COX-2 inhibitor
Manufacturer’s
specifications
Drug Etoricoxib 30mg Tablet
Name of Manufacturer M/s. OBS Pakistan Ltd, C-14, Manghopir Road, SITE, Karachi
Manufacturer of API/pellets M/s Glenmark Pharmaceuticals Ltd. Maharashtra, India
Description of Pack Alu/Alu Blister of 1×10’s×2 packed in unit carton
Real Time: 30°C ± 2°C & 75±5%RH
Time Period Accelerated: 6 months
Real Time: 6 months
Frequency Accelerated: 0, 3, 6 months
Real Time: 0, 3, 6 months
Batch No. 024DS01 024DS02 024DS03
Manufacturing Date March-2017 April-2017 April-2017
Date of Initiation June -2017 June -2017 June -2017
No. of Batches 03
No.
1. COAs of API Copy of COA for Etoricoxib IP from M/s Glenmark
Pharmaceuticals Ltd. Maharashtra, India has been
submitted.
2. Approval of API by regulatory authority of country of Copy of GMP Certificate for M/s Glenmark
origin or GMP certificate of API manufacturer issued Pharmaceuticals Ltd., India issued by Food and Drug
by regulatory authority of country of origin. Administration, Maharashtra State, India valid upto
31-07-2018.
3. Protocols followed for conduction of stability study Yes
respective documents like chromatograms, laboratory
reports, data sheets etc.
5. Documents confirming import of API etc. Copy of commercial invoice for Etoricoxib IP from
M/s Glenmark Pharmaceuticals Ltd, India attested by
ADC (Karachi) has been submitted.
6. All provided documents will be attested (name, sign Yes
and stamp) for ensuring authenticity of data /
documents.
7. Commitment to continue real time stability study till Yes
8. Commitment to follow Drug Specification Rules, Yes
1978.
 The firm has provided 6months Accelerated and 6months Real Time Stability Data for 03 trial batches.
172. M/s. OBS Pakistan Etoricoxib 90mg Tablet Form-5D Arcoxia 90mg tablet
Ltd, C-14, (Brands proposed in Duplicate, 23-12- of MSD, MHRA
Manghopir Road, priority order: Arkoxit, 2016
contains: 7’s, 14’s, & 28’s ;
COX-2 inhibitor
Manufacturer’s
specifications
Real Time: 30°C ± 2°C & 75±5%RH
Real Time: 6 months
Batch No. 024DS01 024DS02 024DS03
No. of Batches 03
No.
submitted.
31-07-2018.
documents.
1978.
173. M/s. OBS Pakistan Etoricoxib 120mg Tablet Form-5D Arcoxia 120mg
Ltd, C-14, (Brands proposed in Duplicate, 23-12- tablet of MSD,
Manghopir Road, priority order: Arkoxit, 2016 MHRA
contains: 7’s, 14’s, & 28’s ;
COX-2 inhibitor
Manufacturer’s
specifications
Real Time: 30°C ± 2°C & 75±5%RH
Real Time: 6 months
Batch No. 024DS01 024DS02 024DS03
No. of Batches 03
No.
submitted.
31-07-2018.
documents.
1978.
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Etoricoxib
(Etoricoxib) 30mg, 90mg & 120mg Tablets by M/s OBS Pakistan Pvt. Limited, C-14, Manghopir Road,
S.I.T.E, Karachi.

Investigation Date and Time: 22nd June, 2018. (Forenoon)
Investigation Site: Factory premises of M/s OBS Pakistan Pvt. Limited, C-14, Manghopir Road, S.I.T.E,
Karachi.
Background:
Chairman Registration Board considered the applications of M/s OBS Pakistan Pvt. Limited, C-14,
Manghopir Road, S.I.T.E, Karachi for registration of Etoricoxib (Etoricoxib) 30mg, 90mg & 120mg 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. (Member Registration Board)
2. Syed Muzaffar Ali Jafri, Director DTL Sindh, Karachi (Member Registration Board)

Etoricoxib 30mg, 90mg & 120mg Tablets
Q. QUESTION OBSERVATION BY PANEL
NO.
1. Do you have documents confirming the Firm has imported 3 kg Etoricoxib from M/S. Glenmark
import of API including approval from Pharmaceuticals limited, India, having Batch number
DRAP? 84160365 vide Invoice No. 2008001557 dated 27-01-2017
2. What was the rationale behind selecting Selection of the manufacturer has been based upon its GMP
the particular manufacturer of API? Certification, DMF availability, desktop audit & vendor
qualification questionnaire.
3. Do you have documents confirming the The firm has imported working standards of API.
import of reference standard and
impurity standards?
4. Do you have certificate of analysis of The firm has certificate of analysis for API & its Working
API, reference standards and impurity standard.
standards
5. Do you have GMP certificate of API The firm has GMP certificate of API Manufacturer issued by
manufacturer issued by regulatory Food & Drug control administration, Gujrat State Gandhinagar.
6. Do you use API manufacturer method of The firm is using API manufacturer method for testing of API.
the testing for testing API?
7. Do you have stability studies report on The firm has stability study reports on API.
API?
8. If yes, whether the stability testing has The stability testing has been performed as per SIM method and
been performed as per SIM and degradation products have been quantified.
quantified?
9. Do you have methods for quantifying the The firm has method for quantifying the impurities in the API.
impurities in API?
10. Do you have some remaining quantities The firm has remaining quantities of the API & working
of API, the reference standards and standard.
impurities?
11. Have you used pharmaceutical grade The firm has used pharmaceutical grade excepients including:
excepients? Microcrystalline cellulose, Croscarmellose sodium, Dibasic
Calcium Phosphate, Lactose Anhydrous, Crosspovidone,
Magnesium stearate, Sheffcoat PVA, Yellow ferric oxide, Talc.
12. Do you have documents confirming the The firm has necessary documents confirming the import of
import of used excepients? used excepients.
13. Do you have test reports and other The firm has test reports & other record on the used excepients.
records 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 Etoricoxib Tablets 30mg, 90mg & 120mg
products?
15. Have you performed drug-excepient The firm has not performed Drug-Excepients compatibility
compatibility studies? studies as their formulation is similar to that of the innovator.
16. Have you performed comparative The firm has performed comparative dissolution study against
dissolution studies? the innovator Arcoxia Tablets manufactured by M/s. MSD,
UK.
17. Do you have product development The firm has dedicated area for product development
(R&D) 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 batches in product development section.
section for development of product?
19. Are the equipments in product The equipments used in production and analyses of trial batches
20. Do you have proper maintenance/ The firm has proper maintenance / calibration / requalification
calibration/requalification program for program for the equipments used in product development
the equipment used in P&D section? section.
21. Do you have qualified staff in product The firm has a team of 6 pharmacists for product development
development section with proper section and 2 pharmacist & 3 chemists in analysis of trial
knowledge and training in product batches with operators, with suitable knowledge and training in
development? 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
Etoricoxib Tablets 30mg
022DS01 Mar-2017 2500 Tabs
022DS02 Apr-2017 2500 Tabs
022DS03 Apr-2017 2500 Tabs
024DS01 Mar-17 2500 Tabs
024DS02 Apr-17 2500 Tabs
024DS03 Apr-17 2500 Tabs
020DS01 Mar-17 2500 Tabs
020DS02 Mar-17 2500 Tabs
020DS03 Apr-17 2500 Tabs
23. Do you have criteria for fixing of the As per statement of the firm, the criteria for fixing the batch
batch size of stability batches? size of stability batches is the number of tablets 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.
production of stability batches? Necessary log book of equipment used have been available
with the firm, assuring the traceability of manufacturing and
analyses of stability batches.
25. Do you have protocols for stability The firm has protocols for stability testing of Stability batches.
testing of stability products?
26. Do you have developed and validated the The method used for testing stability batches of the finished
method for testing of stability batches? product is stability indicating and has been validated using the
working standard of API and also supported by forced
degradation studies.
27. Do you have method transfer studies in The firm has developed & validated their own method of testing
case when the method of testing used by on the basis of API manufacturer’s method of testing. Therefore
your firm is given by another firm? no transfer studies are required.
28. 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
being used in the test and analysis of API API and finished products.
and the finished products?
29. Do your method of analysis stability The method of testing is stability indicating for stability test of
indicating? the 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 was initially not activated. However, now audit trail
product testing? is activated and reports are available from 9 months & onwards
for real time.
32. Do you have some remaining quantities The firm has remaining quantities of stability batches & some
degradation products and stability quantities of working standard of the API.
batches?
33. Do you have stability batches kept on The firm has completed the accelerated stability testing on the
stability testing? three stability batches of Etoricoxib Tablets 30mg, 90mg &
120mg. Real time studies are in progress however studies for
12 months have been completed for all three strengths
34. Do you have valid calibration status for The firm has valid calibration status for the equipment used in
the equipment used in production and production and analysis.
analysis?
35. Do proper and continuous monitoring Continuous power supply and monitoring (data loggers) are
and control are available for stability available for stability chambers. The data is properly reviewed
chamber? on daily basis.
36. Do related manufacturing area, The related manufacturing area, equipment and utilities cannot
equipment, personnel, and utilities be be rated as GMP compliant. The main observations include the
rated as GMP compliant? following.
4. The layout design of the area is very old and not up to the
current standards of GMP.
5. The available HVAC system is not properly designed,
functional and validated, hence posing threats of
contamination and cross contamination
6. Machines are very outdated their qualification is not
possible by design.
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 Etoricoxib (Etoricoxib) 30mg, 90mg & 120mg 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 Etoricoxib (Etoricoxib) 30mg, 90mg & 120mg Tablets.
3. The panel recommends the following improvements to comply with cGMP standards:
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.
4. However, the firm has started the improvement work and ordered the necessary equipment which are
expected to be delivered and installed by December 2018, as per the record/purchase orders available with
the firm.
5. Keeping in view the above statement the panel recommends grant of registration only if the firm agrees not
to manufacture commercial batches of above-mentioned products before the area is improved as per cGMP
standards & the recommendation of the panel.
Decision: Registration Board decided to defer above case for GMP assessment after renovation of tablet
section. Two members panel will evaluate GMP status of tablet section after information by the firm.
Sr. Name & Address Brand Name Type of Form, International Remarks of the
No. of Manufacturer / (Proprietary Name + Initial Diary Availability / Local Evaluator
Applicant Dosage Form + & Date, Fee Availability
Strength), (including
Composition, differential GMP Inspection
Pharmacological fee), Report Date &
Group, Demanded Remarks
Finished Product Price / Pack
Specification size
174. M/s. WeatherFolds EMPAA 10mg Tablet Form-5D Jardiance 10mg film
pharmaceuticals, Each film coated tablet 21051 dated coated tablet of
Plot #69, phase-II contains: 12-06-2018, Boehriger Ingelheim,
industrial estate, Empagliflozin…..10mg Rs. 50,000/-, USFDA
Hattar SGLT2 inhibitor 12-06-2018,
Innovator’s specification As per SRO, GMP inspection dated
As per SRO 15-09-2017 showed
GMP compliant status

Drug EMPAA Tablet 10mg (Empagliflozin)
Name of Manufacturer M/s. WeatherFolds pharmaceuticals, Plot #69, phase-II industrial estate, Hattar
Manufacturer of API/pellets M/s Zhejiang Hongyuan Pharmaceutical Co., Ltd. China.
Description of Pack
Alu-Alu Blister Pack.
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
Frequency Accelerated: 0,1,2,3,4, 6 (Months)
Real Time: 0,3,6 (Months) ongoing
Batch No. T-01 T-02 T-03
No. of Batches 03
No.
1. COAs of API Yes
2. Approval of API by regulatory authority of country Copy of GMP Certificate No. ZJ20180032 issued by
of origin or GMP certificate of API manufacturer Zheijiang Food and Drug Administration, China is
issued by regulatory authority of country of origin. submitted.
5. Documents confirming import of API etc. The firm has submitted copy of commercial invoice
(Invoice No: WC20171009-1) for the import of API not
attested by ADC. However, DHL copy is yet to be
submitted.
documents.
1978.
1. EMPAA Tablet 10mg
Background:
Registration Board considered the applications of M/s. Weatherfolds Pharmaceutical for registration of EMPAA Tablet
10mg. Registration Board decided to constitute the following panel for onsite investigation to confirm genuineness /
authenticity of stability data and associated documents, import of API, quality, specification, test analysis, facilities
etc.
4. Dr. Muhammad Usman, Dean, Faculty of Pharmacy, University of Lahore.
5. Dr. Muhammad Fakhruddin Aamir, Add. Director (QA & LT –II), DRAP Islamabad.
6. Hafiz M. Ali Tayyab, Assistant Director, DRAP, Islamabad.
The inspection report is being submitted for your kind perusal.

Sr.
Description Observation by panel
No.
1. Do you have documents confirming the import of Commercial invoice, coustom clearance and DHL data
Empagliflozin API? confirmed, firm informed that clearance was not
obtained due to small quantity sample and not meant
for commercial manyfacturing.
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) & adequate sample for initial testing for
prequalification.
3. Do you have documents confirming the import of Document for reference attached
Empagliflozin reference standard and impurity
standards?
4. Do you have certificate of Analysis of the API, Yes, except impurity standards.
5. Do you have any approval of API or GMP Copy of GMP certificate having a number
certificate of API manufacturer issued by ZJ20180032 issued for Export Registration by
regulatory authority of country of origin? Licensing Authority Food & Drug administration
China valid for a period from 15-03-2018 to 14-03-
2023.
6. Do you use API manufacturer method of testing? Yes
7. Do you have stability studies reports on API? Available
8. If yes, whether the stability testing has been Not available
performed as per SIM method and degradation
9. Do you have method for quantifying the Method for quantification of impurities of product was
impurities in the API? not evident from provided documents.
10. Do you have some remaining quantities of the API available
API, its reference standard and impurities
standards?
11. Have you used pharmaceutical grade excipients? Yes we use pharmaceutical grade excipients.
12. Do you have documents confirming the import of Not Applicable
the used excipients?
13. Do you have test reports and other records on the Yes, purchased locally. COA available.
excipients used?
14. Do you have written and authorized protocols for Yes
the development of Empagliflozin tablets?
15. Have you performed Drug-excipient No
compatibility studies?
16. Have you performed comparative dissolution Yes
studies?
17. Do you have product development (R&D) No separate product development (R&D) section
section
18. Do you have necessary equipments available in No separate product development (R&D) section
product development section for development of
Empagliflozin tablets?
19. Are the equipments in product development No separate product development (R&D) section
section qualified?
20. Do you have proper maintenance / calibration / No separate product development (R&D) section
re-qualification program for the equipment used
in PD section?
21. Do you have qualified staff in product No separate product development (R&D) section
development section with proper knowledge and
training in product development?
22. Have you manufactured three stability batches Yes
for the stability studies of Empagliflozin tablets
as required?
23. What was the criteria for fixing the batch size of The criteria for fixing the batch size of stability batches
stability batches? is the number of tablets per testing frequency and
number of testing frequencies while keeping in view
the decision of Registration Board (RB).
24. Do you have complete record of production of Yes batch manufacturing record available
stability batches?
25. Do you have protocols for stability testing of Yes
stability batches?
26. Do you have developed and validated the method Validated
for testing of stability batches?
27. Do you have method transfer studies in case NA
when the method of testing being used by your
28. Do you have documents confirming the Yes
qualification of equipments / instruments being
used in the test and analysis of Empagliflozin
API and the finished drug?
29. Is your method of analysis indicating stability? Yes method stability indicating
30. Do your HPLC software is 21CFR compliant? Nave chrome software. Manual registers and rough
data was available.
31. Can you show Audit Trail reports on No, Manual record confirmed
Empagliflozin testing?
32. Do you have some remaining quantities of Stability batches only available
degradation products and stability batches?
33. Do you have commitment batches kept on Yes
stability testing?
34. Do you have valid calibration status for the Yes

equipments used in Empagliflozin tablets
production in analysis?
35. Do proper and continuous monitoring and control Manual record of chamber available
are available for stability chamber?
36. Do related manufacturing area, equipment, The manufacturing facility inspected was GMP
personnel and utilities be rated as GMP compliant.
compliant?
Q.No. Power supply Backup Separate generator available for both QC and
36 Production.
Start within minute after light breakage

100KW for Production
25KW for QC Department
Conclusion:
On the basis of risk based approach the genuineness/authenticity of stability data submitted by the firm for
registration of EMPAA 10mg Tablets is verified to satisfactory level. Related manufacturing area, equipment.
Personnel & utilities are rated as GMP compliant to satisfactory level.
Decision: Registration Board decided to approve registration of “EMPAA 10mg Tablets (Empagliflozin 10 mg)
by M/s. WeatherFolds pharmaceuticals, Plot #69, phase-II industrial estate, Hattar. Manufacturer will place
first three production batches of the product on long term stability studies throughout proposed shelf life and
on accelerated studies for six months.
No. of Manufacturer / (Proprietary Name + Initial Diary & Availability / Local Decision /
Applicant Dosage Form + Date, Fee Availability Remarks
Strength), (including (if any)
Composition, differential fee), GMP Inspection
Pharmacological Demanded Price Report Date &
Group, / Pack size Remarks
Finished Product
Specification
175. M/S Wilson’s Wilsop 30mg Capsule Form 5 Dexilant Delayed Differential fee of
Pharmaceuticals, Each HPMC Dual 11-05-2018 Release Capsule 30mg Rs: 80000/- for
387-388, I-9, Delayed Release Dy. No.17621 of pellets submitted
Industrial Area, capsule contains: Rs.20,000/- USFDA approved Dated :
Islamabad 12-06-2018
Delayed Release 14’s & 28’s Lansodex Capsule
dexlansoprazole pellets As per SRO 30mg of M/S Getz
22.5% eq to Pharma
Dexlansoprazole….… Last inspection was
……..30mg conducted on 24-01-
2018 and report
Proton Pump inhibitor concludes that overall
firm is found to be
(Manufacturers operating at very good
specifications) level GMP of
compliance
Drug Wilsop 30mg Capsule
Name of Manufacturer M/S Wilson’s Pharmaceuticals, Islamabad
Manufacturer of API M/S Alphamed Formulation Pvt Ltd, India
API Lot No. RD0050-006
Description of Pack Alu/Alu
Real Time: 30°C ± 2°C & 65±5%RH
Frequency Accelerated: 0,1,2,3,4,6 (Month)
Real Time: 0,3,6 (Month)
Batch No. Trial#01 Trial#02 Trial#03
Batch Size 1,500 capsules 1,500 capsules 1,500 capsules
Manufacturing Date August – 2017 August – 2017 August – 2017
Date of Initiation August-2017 August-2017 August-2017
No. of Batches 3
1. COA of API Copy of COA from M/s Alphamed formulation Pvt Ltd India
is submitted.
2. Approval of API by regulatory authority of Copy of GMP Certificate No. L.Dis. No.8334/E(M)/TS/2017
country of origin or GMP certificate of API issued by Drugs Control Administration, Govt. of Telangana
manufacturer issued by regulatory authority of is submitted.
country of origin.

5. Documents confirming import of API etc. Copy of ADC (Islamabad) attested dated: 23-06-2017
Commercial Invoice No 025/2017-18 Dated: 07-06-2017
issued by M/s Alphamed formulations, India is submitted.
sign and stamp) for ensuring authenticity of data /
documents.
7. Commitment to continue real time stability study Yes
1978.
Decision:
No. of Manufacturer / (Proprietary Name + Initial Diary & Availability / Local Decision /
Applicant Dosage Form + Date, Fee Availability Remarks
Strength), Composition, (including (if any)
Finished Product Demanded Price Report Date &
Specification / Pack size Remarks
176. M/S Wilson’s Wilsop 60mg Capsule Form 5 Dexilant Delayed Differential fee of
Pharmaceuticals, Each HPMC Dual Delayed 11-05-2018 Release Capsule Rs: 80000/- for
387-388, I-9, Release capsule contains: Dy. No.17622 60mg of pellets submitted
Industrial Area, Rs.20,000/- USFDA approved Dated :
Islamabad Delayed Release 12-06-2018
dexlansoprazole pellets 14’s & 28’s Lansodex Capsule
22.5% eq to As per SRO 60mg of M/S Getz
Dexlansoprazole….…… Pharma
…..60mg
Last inspection was
Proton Pump inhibitor conducted on 24-01-
2018 and report
(Manufacturers concludes that
specifications) overall firm is found
to be operating at
very good level
GMP of compliance
Drug Wilsop 60mg Capsule
Name of Manufacturer M/S Wilson’s Pharmaceuticals, Islamabad
Manufacturer of API M/S Alphamed Formulation Pvt Ltd, India
API Lot No. RD0050-006
Description of Pack Alu/Alu
Real Time: 30°C ± 2°C & 65±5%RH
Frequency Accelerated: 0,1,2,3,4,6 (Month)
Real Time: 0,3,6 (Month)
Batch No. Trial#01 Trial#02 Trial#03
Batch Size 1,500 capsules 1,500 capsules 1,500 capsules
Manufacturing Date August – 2017 August – 2017 August – 2017
Date of Initiation August-2017 August-2017 August-2017
No. of Batches 3
1. COA of API Copy of COA from M/s Alphamed formulation Pvt Ltd India
is submitted.
2. Approval of API by regulatory authority of Copy of GMP Certificate No. L.Dis. No.8334/E(M)/TS/2017
country of origin or GMP certificate of API issued by Drugs Control Administration, Govt. of Telangana
manufacturer issued by regulatory authority of is submitted.
country of origin.

5. Documents confirming import of API etc. Copy of ADC (Islamabad) attested dated: 23-06-2017
Commercial Invoice No 025/2017-18 Dated: 07-06-2017
issued by M/s Alphamed formulations, India is submitted.
sign and stamp) for ensuring authenticity of data /
documents.
7. Commitment to continue real time stability study Yes
1978.
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Wilsop 30mg and 60mg
(Dexlansoprazole) Capsules by M/s. Wilson’s Pharmaceuticals, 387-388, I-9, Industrial Area, Islamabad.
Reference No: F.13-11/2017-PEC dated 21st March, 2018.
Investigation Date and Time: 26nd June, 2018 (Evening).
Investigation Site: Factory premises of M/s. Wilson’s Pharmaceuticals, 387-388, I-9, Industrial Area, Islamabad.
Background:
The Chairmain Registration Board has approved the following panel for on-site investigation to confirm
authenticity / genuineness of stability data and associated documents, import of API, Quality, Specification, test analysis,
facilities etc.
a. Dr. Qurban Ali, (Member Registration Board).
b. Mr. Zaheer Ud Din Babar, Deputy Director, DRAP, Islamabad
c. Hafiz Ahsan, Assistant Director, PE&R Division, DRAP
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 3kg Dexlansoprazole DDR 22.5% pellets
import API including approval from from M/s. Alphamed Formulations, India Batch No. RD-0050-
DRAP? 006. Invoice No. 025/2017-2018 and material is cleared by
ADC.
2. What was the rationale behind selecting the The firm has selected the API manufacturer on the basis of its
particular manufacturer of API? GMP compliance and provision of stability studies of
Dexlansoprazole DDR 22.5% pellets.
3. Do you have documents confirming the The firm has imported Lansoprazole working standard (10gm)
import of API reference standard and and one major impurity standard i.e., Lansoprazole sulphone
impurity standards? Impurity (25mg) from Synpure Labs, India
4. Do you have certificate of Analysis of the The firm has certificates of analysis for API, reference standard
API, reference standards and impurity of API and one major impurity standard.
standards?
5. Do you have GMP certificate of APIs The firm has GMP certificate of M/s. Alphamed formulations,
manufacturer issued by regulatory India issued by Drug Control Administration, Government of
authority of country of origin? Telangana, India.
6. Do you use APIs manufacturer method of The firm has used API manufacturer method of testing.
testing for testing APIs?
7. Do you have stability studies reports on The firm has stability study reports on API conducted by the
API? API manufacturer. Real time (30oC±2 oC/65%±5% RH) at
0,3,6,9,12,18, 24,36 months and Accelerated time (40oC±2
o
C/75%±5% RH) at 0,1,2,3,6 months.
8. If yes, whether the stability testing has been Stability testing has been performed as per SIM method and
performed as per SIM method and degradation products have been quantified.
quantified?
9. Do you have method for quantifying the The firm has manufacturer method for quantifying the
impurities in the API? impurities in the API.
10. Do you have some remaining quantities of The firm has remaining quantities of the API (1.187g), its
the API, its reference standard and reference standard (3g), impurity standard (10mg).
11. Have you used pharmaceutical grade Since the product is filling of already prepared granules in Hard
excipients? HPMC capsule, therefore, the only excipient used is Hard
HPMC capsule (size # 1) which are of pharmaceutical grade as
per the COA and related documents.
12. Do you have documents confirming the The firm has purchased from local source Gudia Packaging,
import of the used excipient? Karachi and COA is from Suheung Co., Ltd. Korea.
13. Do you have test reports and other records The firm has test reports and other records on the excipient used.
on the excipients used?
14. Do you have written and authorized The firm has written and authorized protocol for the
protocols for the development of development of Dexlansoprazole DR 30mg and 60mg
Dexlansoprazole DR 30mg and 60mg Capsules. However, QMS practices are required to be adopted
Capsules? especially for SOPs as control documents.
15. Have you performed Drug-excipients Not applicable.

compatibility studies?
16. Have you performed comparative The firm has performed comparative dissolution studies with
dissolution studies? 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 development (R&D)
section section.
18. Do you have necessary equipment The firm has dedicated manufacturing and testing equipment in
available in product development section product development section for the development of capsule
for development of Dexlansoprazole DR formulations.
30mg and 60mg Capsules?
19. Are the equipments in product The available equipments in product development section are
20. Do you have proper maintenance / The firm has proper maintenance / calibration / re-qualification
calibration / re-qualification program for program for the equipment used in Product Development
the equipment used in PD section? section.
21. Do you have qualified staff in product The firm has a team of skilled and qualified staff in product
development section with proper development section with proper knowledge and training in
development?
22. Have you manufactured three stability Three stability batches have been manufactured for stability
batches for the stability studies of studies of Dexlansoprazole DDR 30mg and 60mg Capsules with
Dexlansoprazole DR 30mg and 60mg batch numbers Trial#01, Trial#02 and Trial#03. The batch sizes
capsules as required? for all three batches of both potencies are 1500 Capsules each.
The capsules are packed in AluAlu blisters.
23. Do you have any criteria for fixing the The criteria for fixing the batch size of stability batches is based
batch size of stability batches? on the number of Capsules per testing frequency and the number
24. Do you have complete record of production The firm has complete record of production of stability batches.
of stability batches?
25. Do you have protocols for stability testing The firm has detailed protocols for stability testing of stability
of stability batches? batches.
26. Do you have developed and validated the The firm has performed detailed analytical method validation
method for testing of stability batches? studies for the testing of Dexlansoprazole DDR 30mg and 60mg
Capsules.
27. Do you have method transfer studies in The firm has conducted complete validation studies on their
case when the method of testing being used analytical method used.
by your firm is given by any other lab?
qualification of equipments / instruments equipment / instruments being used in the test and analysis of
being used in the test and analysis of API API and the finished drug.
and the finished drug?
29. Does your method of analysis stability The firm method of analysis is stability Indicating method.
indicating?
30. Do your HPLC software 21CFR The firm has HPLC software (LC Lab solution) which is 21CFR
Compliant? Compliant.
31. Can you show Audit trail reports? The firm has audit trail reports of the stability studies of all three
batches and same were verified from the relevant system.
32. Do you have some remaining quantities of The firm has remaining quantities of stability batches.
degradation products and stability batches?
33. Do you have stability batches kept on The firm has kept all the three laboratory scale batches of both
stability testing? potencies on real-time stability testing. The 09 month studies
have been completed.
the equipments used in Dexlansoprazole Dexlansoprazole DR 30mg and 60mg Capsules production and
DR 30mg and 60mg Capsules production analysis.
and analysis?
35. Do proper and continuous monitoring and The firm has adequate monitoring and controls available for
control are available for stability chamber? stability chambers provided with uninterrupted power supply
and data loggers which are set for recording temperature and
humidity.
36. Do related manufacturing area, equipment, The related manufacturing area, equipment, personnel and
personnel and utilities be rated as GMP utilities are GMP compliant.
compliant?
Conclusions:
1. On the basis of risk based approach the genuineness / authenticity of stability data submitted by the firm for
registration of Wilsop 30mg and 60mg (Dexlansoprazole) is verifiable to satisfactory level.
2. The related manufacturing area, equipments, personnel and utilities are GMP compliant and well suited for the
manufacturing of Wilsop 30mg and 60mg (Dexlansoprazole) Capsule.
Decision: Registration Board decided to approve registration of “Wilsop 30mg and 60mg (Dexlansoprazole)
Capsules” by M/s. Wilson’s Pharmaceuticals, 387-388, I-9, Industrial Area, Islamabad. 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.
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), Composition, fee), GMP Inspection Report
Pharmacological Group, Demanded Price / Pack Date & Remarks
Finished Product size
Specification
177. M/s. Macter International Fenid capsule 267 mg Form-5-D Esbriet by M/s Genetech.
Limited, F-216, S.I.T.E, Each hard capsules Dy. No: 634 (USFDA)
Karachi contains:- Dated.24/4/15
Pirfenidone…..267mg Rs.50,000/- (8/4/15) Not applicable
(anti-fibrotic) 1277/- capsule
In-house specifications The firm was granted GMP
certificate based on
inspection conducted on 07-
08-2017 and 17-10-2017.

Drug Fenid capsule 267 mg
Name of Manufacturer M/s. Macter International Limited, F-216, S.Ib, .T.E, Karachi
Manufacturer of API Pirfenidone: ZCL Chemicals Limited. 3102/, B GIDC, Industrial estate, Ankleshwar
city Ankleshwar-393002 District, Bharuch, Gujrat state India
.
API Lot No. FEN3300216 (Pirfenidone)
Description of Pack
Alu Alu blister packed in unit cartoon
Frequency Accelerated: 0,1, 3,6 (month)
Real Time: 0,1, 3,6,9, 12 (month)
Batch Size 3000 3000 3000

Date of Initiation 15-3- 2017 15-3- 2017 15-3- 2017
No. of Batches 03
Date of Submission 23-5-2018 (Dy. No.18779)
No.
1. COA of API YES
2. Approval
0 of API by regulatory authority of country of Pirfenidone: Copy of GMP certificate issued by
origin or GMP certificate of API manufacturer issued by Food and Drugs control administration, Gujrat state
regulatory authority of country of origin. India to, ZCL Chemicals Limited. 3102/, B GIDC,
Industrial estate, Ankleshwar city Ankleshwar-393002
District, Bharuch, Gujrat state India valid upto 23-6-
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. Pirfenidone: Copy of commercial invoice has been
submitted issued by ADC, Karachi DRAP.
Import quantity: 15 kg
Working standard: 5 g
Impurities: 50 mg
Address of Exporter (Head office): ZCL Chemicals
Limited. 819-821, C wing 215 Atrium, Chakala, Andheri
Kurla road Andheri (East) Mumbai-400 0069,
Maharastra India
Address of Consignee: M/s. Macter International
Limited, 44-H, PECHS,Block-6, Razi Road, 75400
Karachi
6. All provided documents will be attested (name, sign and
Yes
stamp) for ensuring authenticity of data / documents.
Yes
8. Commitment to follow Drug Specification Rules, 1978. Yes
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Fenid 267mg
(Pirfenidone) Capsule by M/s. Macter International Ltd., F-216, S.I.T.E, Karachi.

Investigation Date and Time: 27th June, 2018. (Morning).
Investigation Site: M/s. Macter International Ltd., F-216, S.I.T.E, Karachi.
Background:enterprises
The Chairman Registration Board considered the applications of M/s. Macter International Ltd., F-216, S.I.T.E,
Karachi for registration of Fenid 267mg (Pirfenidone) Capsule. The PE&R Division considered scientifically rational
laboratory scale data submitted by the firm as pre-requisite of registration being new formulation and constituted the
following 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.
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. Question Observation
1. Do you have documents confirming the The firm has imported 15kg Pirfenidone from M/s ZCL
import of Pirfenidone API including Chemicals Limited, Gujrat, India. There is proper approval
approval from DRAP? from DRAP Karachi.
2. What was the rationale behind selecting The rationale behind selecting the particular manufacturer of
the particular manufacturer of API? API is the vendor evaluation process based on audit and other
criteria like manufacturer GMP status, DMF source etc.
3. Do you have documents confirming the The firm has imported Pirfenidone working standard and two
import of Pirfenidone reference standard impurity standards (Impurity A and B) from the API
and impurity standards? manufacturer.
4. Do you have certificate of Analysis of the The firm has Certificate of Analysis of API, working standard
API, reference standards and impurity of API and impurities standards.
standards?
5. Do you have GMP certificate of API The firm has GMP certificates for API manufacturer issued by
manufacturer issued by regulatory Food and Drugs Control Administration, Gujrat State, India.
6. Do you use API manufacturer method of Since the API Monograph is included in European
testing for testing API? Pharmacopoeia, therefore the firm has used the same method of
testing for API.
7. Do you have stability studies reports on The firm has stability studies report on API (Pirfenidone)
APIs? conducted by API manufacturer.
8. If yes, whether the stability testing has The manufacturer of API has performed the stability studies as
been performed as per SIM method and per SIM method. Since Impurity A is the key starting material
degradation products have been related impurity and Impurity B is process related impurity,
therefore, their quantification could not be made during the
quantified?
stability studies.
9. Do you have method for quantifying the The two major impurities related to the API are Impurity A & B
impurities in the API? which can be quantified while using the related substances
method of European Pharmacopoeia.
10. Do you have some remaining quantities The firm has some remaining quantities of API (Pirfenidone)
of the API, its reference standard and working standard and impurity standard.
11. Have you used pharmaceutical grade The firm has used pharmaceutical grade excipients including
excipients? Microcrystalline cellulose, Povidone K-30, Croscarmellose
sodium, and Magnesium stearate.
12. Do you have documents confirming the The firm has necessary documents confirming the import of the
import of the used excipients? used excipients.
13. Do you have test reports and other The firm has test reports and other records for the excipients
14. Do you have written and authorized The firm has written and authorized protocol for the development
protocols for the development of of Fenid (Pirfenidone) 267mg Capsules.
Pirfenidone Capsules?
15. Have you performed Drug-excipient The firm has not performed Drug-Excipient compatibility studies
compatibility studies? as composition of their product is similar to that of innovator
product (Esbriet Capsule, Roche, Switzerland).
16. Have you performed comparative The firm has performed comparative dissolution profile of Fenid
dissolution studies? 267mg Capsules against Esbriet 267mg Capsule of the innovator.
The firm’s Capsules have shown comparable dissolution profile
with that of the innovator Capsules.
17. Do you have product development (R&D) The firm has product development (R&D) section with requisite
section manufacturing, storage and analysis facilities.
18. Do you have necessary equipments The firm has all the necessary equipment available in product
available in product development section development section for the development of Pirfenidone
for development of Pirfenidone Capsules? Capsules.
19. Are the equipment in product The equipments in product development section are qualified.
development section qualified?
20. Do you have proper maintenance / The firm has proper maintenance / calibration / re-qualification
calibration / re-qualification program for program for the equipment used in PD section.
the equipment used in PD section?
21. Do you have qualified staff in product The firm has qualified staff in PD section with proper knowledge
development section with proper and training in Product Development including 01 Ph.D., 02
Pharmacists and 04 MSc Chemistry.
knowledge and training in product
development?
22. Have you manufactured three stability The firm has manufactured three stability batches as follows;
batches for the stability studies of Pirfenidone 267mg Capsules:
Pirfenidone Capsules required? Sr. No. B. No. Batch size
1 001P 3,000
2 002P 3,000
3 003P 3,000
The Capsules are packed in Alu Alu blisters with pack size 3 x
10s.
23. Do you have any criteria for fixing the The criteria for fixing the batch size of stability batches is the
batch size of stability batches? number of Capsules required per testing frequency and number
24. Do you have complete record of The firm has complete records of production of stability batches.
production of stability batches? All log books are properly maintained.
25. Do you have protocols for stability testing The firm has detailed protocol for the stability testing of
of stability batches? Pirfenidone Capsules.
26. Do you have developed and validated the The firm has developed and validated method for testing of
method for testing of stability batches? stability batches of finished product. The method is stability
indicating as evidenced by the forced degradation studies. It is
pertinent to state that there is no significant degradation at the
forced degradation conditions hence, no degradation products
could be observed at LOD level.
27. Do you have method transfer studies in Not Applicable.
lab?
qualification of equipment / instruments equipment / instruments being used in the test and analysis of the
being used in the test and analysis of API (Pirfenidone) and the finished drug Fenid (Pirfenidone)
Capsules.
Pirfenidone and the finished drug?
29. Do your method of analysis stability The firm method of analysis is stability indicating as evidenced
indicating? by forced degradation studies. However no degradation products
could be identified as there is no degradation at the accelerated
storage conditions and the real time storage conditions.
30. Do your HPLC software 21CFR The HPLC software is 21CFR compliant as per record of the
Compliant? firm.
31. Can you show Audit trail reports on Audit Trail on the testing reports on Pirfenidone API and Fenid
Pirfenidone testing? Capsules is available.
32. Do you have some remaining quantities The firm has only remaining quantities of stability batches kept
of degradation products and stability on real-time stability testing.
batches?
33. Do you have stability batches kept on The firm has three lab scale batches kept on stability studies for
stability testing? real time stability testing. Currently 12 months studies have been
completed with satisfactory results.
the equipment used in Pirfenidone Fenid (Pirfenidone) Capsules production and analysis.
Capsules production and analysis?
35. Do proper and continuous monitoring and The firm has adequate monitoring and control system for stability
control are available for stability chambers.
chamber?
36. Do related manufacturing area, The related manufacturing area, equipments, personnel and
equipment, personnel and utilities be utilities are GMP compliant.
Conclusions:
1. On the basis of risk based approach the genuineness / authenticity of stability data submitted by the firm for
registration of Fenid 267mg (Pirfenidone) Capsules is verifiable satisfactory level.
2. The related manufacturing area, equipments, personnel and utilities are GMP compliant and well suited for the
manufacturing of Fenid 267mg (Pirfenidone) Capsules, hence registration of Fenid 267mg Capsules is
recommended.
Decision: Registration Board decided to approve registration of “Fenid 267mg (Pirfenidone) Capsules” of M/s.
Macter International Ltd., F-216, S.I.T.E, Karachi. Manufacturer will place first three production batches of all
three products 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 REMARKS
No. Manufacturer / (Proprietary Name + Dosage Initial Diary & Date, Availability / (IF ANY)
Applicant Form + Strength), Fee (including Local
Composition, differential fee), Availability
Pharmacological Group, Demanded Price /
Finished Product Pack size GMP
Specification Inspection
Report Date &
Remarks
178. M/s. Schazoo Zaka Tablet RIFA 2 Junior Form-5D WHO Deferred in
(Pvt.) Ltd. 20-km recommended 262nd Meeting
Lahore Jaraanwala Each uncoated dispersible Dy. No: 1876 formulation. of DRB for
Road, Sheikhupura. tablet contains: 19-04-2016 submission of
Rifampicin USP …75mg GMP compliant stability data
Isoniazid USP ...50mg Rs. 50,000/- section vide as per
(20,000 + 30,000) inspection guidelines
Anti TB report dated 15- approved in
Mfg. Specs. Rs. 11.33/- Per tablet. 09-2015. 251st DRB
meeting.
Drug Tablet RIFA 2 Junior (Rifampicin + Isoniazid)
Name of Manufacturer M/s. Schazoo Zaka (Pvt.) Ltd., Sheikhupura
Shenyang Tonglian Medicine Co. Ltd., China.
Manufacturer of API
Amsal/Calyx
Rifampicin: 80201512041
API Lot No.
Isonazid: 16058INH
Description of Pack Alu-Alu Blister Pack.
Real Time: 30°C ± 2°C / 65% ± 5%RH
Stability Storage Condition
Real Time: 3 Months (12 Weeks)
Time Period
Accelerated: 3 Months (12 Weeks)
Real Time: 0,12 (Weeks)
Frequency
Accelerated: 0,4,8,12 (Weeks)
Batch No. RDT-T1-16 - -
Batch Size 5,000 Tablets - -
Manufacturing Date May 2016 - -
Date of Initiation July 2016 - -
No. of Batches 01
Date of Submission 13-12-2016
1. COA of API No
2. Approval of API by regulatory authority of country of
origin or GMP certificate of API manufacturer issued by No
regulatory authority of country of origin.
Yes
details of tests.
4. Data of 03 batches will be supported by attested respective
Copies of chromatograms, laboratory reports, data
documents like chromatograms, laboratory reports, data
sheets etc. provided for one batch only.
sheets etc.
No

No
Yes
8. Commitment to follow Drug Specification Rules, 1978. No
 Firm has provided 03 months accelerated and long term stability study results for one batch only.
 Aforementioned documents as required in 251st DRB Meeting are missing.
Decision of 267th meeting: Registration Board deferred the case for submission of the following documents:
 COA of API.
 Approval of API by regulatory authority of country of origin or GMP certificate of API manufacturer issued by
 Data of 03 batches supported by attested respective documents like chromatograms, laboratory reports and data
sheets etc.
 Documents confirming import of API etc.
 All provided documents will be attested (name, sign and stamp) for ensuring authenticity of data / documents.
 Commitment to follow Drug Specification Rules, 1978.
Evaluation by PEC:
Firm has submitted stability data in reply to decision of 267th Meeting of Registration Board. Detail of submitted data are
as under:
STABILITY STUDY DATA SUBMITTED RECENTLY
Drug Tablet RIFA 2 Junior (Rifampicin + Isoniazid)
Rifampicin: M/s Shenyang Antibiotic Manufacturer China
Manufacturer of API
Isonazid: M/s Amsal Chemicals (Pvt.) Ltd. Gujarat, India
Rifampicin: 80201512041 & 1703030 (M)
API Lot No.
Isonazid: 17028/INH, 1704/INH & 16058/INH
Description of Pack
Alu-Alu Blister further packed in bleach board carton.
Real Time: 30°C ± 2°C / 65% ± 5%RH
Time Period
Real Time: 0,3 & 6 (months)
Frequency
Batch No. RDT-T1-16 RDT –T1-17 RDT-T2-17
Manufacturing Date May 2016 08-2017 08-2017
Date of Initiation July 2016 29-10-2017 29-10-2017
No. of Batches 03
1. COA of API Yes
2. Approval of API by regulatory authority of country of Rifampicin: Copy of GMP certificate (Certificate no.
origin or GMP certificate of API manufacturer issued by LN20140013) for the M/s Shenyang Antibiotic
regulatory authority of country of origin. Manufacturer has been submitted, issued by CFDA,
and valid upto 04-15-2019.
Isoniazid: Copy of GMP certificate (Certificate no.
WC-0172) for the M/s Amsal Chemicals (Pvt.) Ltd.
Gujarat, India has been submitted, issued by CDSCO,
India, and valid upto 02-07-2019.
Yes
details of tests.
sheets etc.
Yes (Copies of invoices attested by ADC, DRAP,
Lahore have been submitted)

Yes
Yes
 Significant change has been reported in assay analysis during stability data, which is within the limits assigned for shelf
life specifications.
Sr. Name & Address of Brand Name Type of Form, International REMARKS
No. Manufacturer / (Proprietary Name Initial Diary & Date, Fee Availability / (IF ANY)
Applicant + Dosage Form + (including differential fee), Local
Strength), Demanded Price / Pack size Availability
Composition,
Pharmacological GMP
Group, Inspection
Finished Product Report Date
Specification & Remarks
179. M/s. Schazoo Zaka RIFA 3 Junior Form 5-D WHO Deferred in
nd
(Pvt.) Ltd. Dispersible Tablets Dy. No: 1875 recommended 262 Meeting
19-04-2016 formulation. of DRB for
20-km Lahore Each uncoated submission of
Jaraanwala Road, dispersible tablet Rs.20,000/- GMP stability data as
Sheikhupura. contains: compliant per guidelines
Rifampicin 13.33/- section vide approved in
USP…75mg Per tablet inspection 251 st
DRB
Isoniazid report dated 15- meeting.
USP…50mg 09-2015.
Pyrazinamide
…150mg
Anti TB
Mfg. Specs.
RIFA 3 Junior Dispersible Tablets
Drug
(Rifampicin + Isoniazid+ Pyrazinamide)
Shenyang Tonglian Medicine Co. Ltd., China.
Manufacturer of API Amsal Chemicals (Pvt.) Ltd., India.
Calyx Chemicals and Pharmaceuticals Ltd., India.
Rifampicin: 80201512041
API Lot No. Isonazid: 16058INH
Pyrazinamide: PZ/20151020
Description of Pack
Alu-Alu Blister Pack.
Real Time: 30°C ± 2°C / 65% ± 5%RH
Time Period
Real Time: 0,12 (Weeks)
Frequency
Accelerated: 0,4,8,12 (Weeks)
Batch No. RKT-T1-16 - -
Batch Size 5,000 Tablets - -
Manufacturing Date May 2016 - -
Date of Initiation July 2016 - -
No. of Batches 01
1. COA of API No
2. Approval of API by regulatory authority of country of
origin or GMP certificate of API manufacturer issued by No
Yes
details of tests.
sheets etc.
5. Documents confirming import of API etc. No
Copies provided.
Yes
8. Commitment to follow Drug Specification Rules, 1978. No
1
 Aforementioned documents as required in 251st DRB Meeting are missing.
Decision of 267th meeting: Registration Board deferred the case for submission of the following documents:
 COA of API.
 Approval of API by regulatory authority of country of origin or GMP certificate of API manufacturer issued by
 Data of 03 batches supported by attested respective documents like chromatograms, laboratory reports and data
sheets etc.
 Documents confirming import of API etc.
 All provided documents will be attested (name, sign and stamp) for ensuring authenticity of data / documents.
 Commitment to follow Drug Specification Rules, 1978.
Evaluation by PEC:
Firm has submitted stability data in reply to decision of 267th Meeting of Registration Board. Detail of submitted data are
as under:
STABILITY STUDY DATA SUBMITTED RECENTLY
RIFA 3 Junior Dispersible Tablets
Drug
(Rifampicin + Isoniazid+ Pyrazinamide)
Rifampicin: M/s Shenyang Antibiotic Manufacturer China
Manufacturer of API Isoniazid: M/s Amsal Chemicals (Pvt.) Ltd. Gujarat, India
Pyrazinamide: M/s Calyx Chemicals & Pharmaceuticals Ltd., Maharashtra, India.
Rifampicin: 80201512041 & 1703030 (M)
API Lot No. Isoniazid: 17028/INH, 1704/INH & 16058/INH
Pyrazinamide: PZ/20161218 & PZ/20151020
Description of Pack
Alu-Alu Blister further packed in bleach board carton.
Real Time: 30°C ± 2°C / 65% ± 5%RH
Time Period
Real Time: 0,3 & 6 (months)
Frequency
Batch No. RKT-T1-16 RKT –T1-17 RKT-T2-17
Manufacturing Date May 2016 08-2017 08-2017
No. of Batches 01
1. COA of API Yes
2. Approval of API by regulatory authority of country of Rifampicin: Copy of GMP certificate (Certificate no.
origin or GMP certificate of API manufacturer issued by LN20140013) for the M/s Shenyang Antibiotic
regulatory authority of country of origin. Manufacturer has been submitted, issued by CFDA,
and valid upto 04-15-2019.
Isoniazid: Copy of GMP certificate (Certificate no.
WC-0172) for the M/s Amsal Chemicals (Pvt.) Ltd.
Gujarat, India has been submitted, issued by CDSCO,
India, and valid upto 02-07-2019.
Pyrazinamide: Copy of GMP certificate (Certificate
no. NEW-WHO-
GMP/CERT/KD/58406/2017/11/19436) for the M/s
Calyx Chemicals & Pharmaceuticals Ltd.,
Maharashtra, India has been submitted, issued by
FDA Maharashtra, and valid upto 25-05-2019.
Yes
details of tests.
sheets etc.
Yes (Copies of invoices attested by ADC, DRAP,
Lahore have been submitted)

Yes
Yes
 Significant change has been reported in assay analysis during stability data, which is within the limits assigned for shelf
life specifications.
Report of Panel inspection for verification of authenticity of stability data
General Information
Name of Manufacturer M/s SchazooZaka (Pvt.) Ltd.
Kalalwala, 20-Km, Lahore Jaranwala Road, District Sheikhupura,
Physical Address
Pakistan
Date of Inspection 28th June, 2018
Purpose of Inspection Panel inspection for verification of authenticity of stability data for
purpose of registration of drugs with reference to DRAP Islamabad
letter No. F.13-11/2017-PEC dated 26th June, 2018
Name of Inspectors Mr.Asim Rauf (Additional Director, DRAP, Lahore)
Ms.UzmaBarkat (Assistant Director, DRAP, Lahore)
Mr. Shoaib Ahmed (Federal Inspector of Drugs, DRAP, Lahore)
Name of firm representatives Mr. Irfan Ahmad Khan (Production Manager)
accompanying during inspection Mr. Muhammad Shahjehan (Quality Assurance Manager)
Mrs. Sobia Mehboob ( Research & development Manager)
Mr. Muhammad Awais (Quality control Manager)
Focus of Inspection
The inspection of M/s SchazooZakaPvt Ltd, Lahore was conducted with reference to DRAP Islamabad letter no. reference
to DRAP Islamabad letter No. F.13-11/2017-PEC dated 26th June, 2018, for verification of authenticity of stability data of
products namely Tablet RIFA 2 Junior Dispersible and RIFA 3 Junior Dispersible Tablet. The panel evaluated the relevant
documentation and also visited the production area, Product Development laboratory and quality control laboratory of the
company.
The data of both products was evaluated in accordance with the checklist provided as given below.
Detail of Investigation
A. Tablet Dispersible RIFA 2 Junior (Rifampicin + Isoniazid)
Sr. Question Observation by Panel
No.
Firm had imported Rifampicin from two sources namely,
Shenyang Antibiotic Manufacturer, China,
Do you have documents confirming the import of
1. andLuoheNanjiecun Pharmaceutical Group Pharmacy,
API?
China.Isoniazid was imported from AmselChem Pvt. Ltd.
Ankleshwar, India. Copies of import invoices were also seen.
Firm has a vendor approval system and according to the firm,
the rationale behind selecting the manufacturer is its GMP
What was the rationale behind selecting the
2. status and evaluation as per SOP for vendor approval. All
these are approved vendors & WHO prequalified units as
informed by the technical team.
Do you have documents confirming the import of Purchase invoice of reference standard and Rifampicin
reference standard and impurity standards? quinone impurity reference standard was available. The
3. technical team informed thatworking standards of three
impurities of Isoniazid were brought from the vendor by
Madam Zeba (Technical Director) in her luggage.
Do you have certificate of Analysis of the API, Available
4.
Do you have any approval of API or GMP GMP certificate available.
5. certificate of API manufacturer issued by
regulatory authority of country of origin?
6. Do you use API manufacturer method of testing? Compendialmonograph testing was applied.
Do you have stability studies reports on API? Stability testing report of principal manufacturer was
7.
available.
If yes, whether the stability testing has been Compendial methods have been applied for testing of related
8. performed as per SIM method and degradation substances.
Do you have method for quantifying the Compendial methods have been applied for testing of related
9.
impurities in the API? substances.
Do you have some remaining quantities of the Yes, some remaining quantities were available.
10. API, its reference standard and impurities
standards?
11. Have you used pharmaceutical grade excipients? Yes, firm has used pharmaceutical grade excipients.
Do you have documents confirming the import of Yes, firm has necessary documents confirming the import of
12.
the used excipients? the excipients used in product.
Do you have test reports and other records on the Yes, the firm has test reports and other record of the excipients
13.
excipients used? used.
Do you have written and authorized protocols for SOPs were available. Trial manufacturing record was also
14.
the development of product? provided.
Have you performed Drug-excipient Drug-excipient compatibility studies were not performed.
15.
compatibility studies? Firm was advised to perform these studies.
Have you performed comparative dissolution Comparative dissolution studies have not been performed.
16. studies? Panel is of the view that dissolution testing is not mandatory
for dispersible tablets as per USP.
Do you have product development (R&D) Yes, firm has R&Ddepartment.
17.
section?
Do you have necessary equipment available in Yes, firm has necessary equipment available in product
18. product development section for development of development section.
the product?
Are the equipment in product development Yes, the equipment in product development section were
19.
section qualified? qualified. Equipment qualification protocols were available.
Do you have proper maintenance / calibration / Yes, firm has a maintenance / calibration / re-qualification
20. re-qualification program for the equipment used program for the equipment used in PD section.
in PD section?
Do you have qualified staff in product Yes, firm has qualified and trainedstaff in product
development section with proper knowledge and development section.
21. training in product development? Remarks: The panel advised the firm management to arrange
product development focused additional trainings for the staff
in R&D department.
Have you manufactured three stability batches Yes, firm has manufactured three stability trial batches for the
22.
for the stability studies of product as required? stability studies.
What was the criteria for fixing the batch size of The criteria for fixing the Batch size of stability batches was
23.
stability batches? based on the minimum capacity of production equipment.
Do you have complete record of production of Yes, firm has complete record of production of stability
stability batches? batches. However, it was noted that in first trial batch No.
RDT-T1-16,source of Rifampicin was Shenyang Antibiotic
24.
Manufacturer, China and in next two trials RDT-T1-17 and
RDT-T2-17, source of Rifampicin was LuoheNanjiecun
Pharmaceutical Group Pharmacy, China.
Do you have protocols for stability testing of Yes, firm has protocols for stability testing of stability
25.
stability batches? batches.
Do you have developed and validated the method Existing validated methods for already registered products of
26. for testing of stability batches? firm of same API combination were used but not verified for
this product.
Do you have method transfer studies in case Pharmacopoeial methods were used.
27. when the method of testing being used by your
Do you have documents confirming the Yes, firm has documents confirming the qualification of
qualification of equipment / instruments being equipment / instruments being used in the test and analysis of
28.
used in the test and analysis of API and the API and finished drug product.
finished drug?
Is your method of analysis stability indicating? Yes, method has beenadopted from IP.
29.
Do your HPLC software is 21CFR compliant? Three HPLCs were used for analysis of stability batches. Two
30. HPLCs system were compliant and one was not compliant
during stability studies.
Audit trail was available for testing done on HPLC 10 and
Can you show Audit Trail reports on product HPLC 20. Majority testing was done on RD 003 HPLC
31.
testing? available in R&D department on which audit trail was not
activated during stability studies.
Do you have some remaining quantities of Yes remaining quantities of impurities are available. Stability
32. degradation products and stability batches? batches for accelerated studies have been discarded after
completion of studies.
Do you have commitment batches kept on No, commitment batches will be made after drug registration.
33.
stability testing?
Do you have valid calibration status for the Yes
34.
equipment used in production and analysis?
Is proper and continuous monitoring and Yes, monitoring and control was available for the stability
35.
controlavailable for stability chamber? chambers provided. Data logger had been provided.
Can related manufacturing area, equipment, Yes
36. personnel and utilities be rated as GMP
compliant?
B. RIFA 3 Junior Dispersible Tablet (Rifampicin + Isoniazid + Pyrizinamide)

Sr. Question Observation by Panel
No.
Firm had imported Rifampicin from two sources namely,
Shenyang Antibiotic Manufacturer, China, and LuoheNanjiecun
Pharmaceutical Group Pharmacy, China. Isoniazid was
Do you have documents confirming the
1. imported from AmselChem Pvt. Ltd. Ankleshwar, India.
import of API?
Pyrazinamide was imported from Caylex Chemicals &
Pharmaceuticals Ltd, India. Copies of import invoices were also
seen.
Firm has a vendor approval system and according to the firm,
the rationale behind selecting the manufacturer is its GMP status
What was the rationale behind selecting the
2. and evaluation as per SOP for vendor approval. All these are
approved vendors & WHO prequalified units as informed by the
technical team.
Do you have documents confirming the Purchase invoice of reference standard and Rifampicin quinone
import of reference standard and impurity impurity reference standard was available. The technical team
3. standards? informed that working standards of impurity of Pyrazinamide &
three impurities of Isoniazid were brought from the vendor by
Madam Zeba (technical Director) in her luggage.
Do you have certificate of Analysis of the Available
4. API, reference standards and impurity
standards?
Do you have any approval of API or GMP GMP certificate available.
5. certificate of API manufacturer issued by
regulatory authority of country of origin?
Do you use API manufacturer method of Compendial monograph testing was applied.
6.
testing?
7. Do you have stability studies reports on API? Stability testing report of principal manufacturer was available.
If yes, whether the stability testing has been Compendial methods have been applied for testing of related
8. performed as per SIM method and substances.
degradation products have been quantified?
Do you have method for quantifying the Compendial methods have been applied for testing of related
9.
impurities in the API? substances.
Do you have some remaining quantities of the Yes, some remaining quantities were available.
10. API, its reference standard and impurities
standards?
Have you used pharmaceutical grade Yes, firm has used pharmaceutical grade excipients.
11.
excipients?
Do you have documents confirming the Yes, firm has necessary documents confirming the import of the
12.
import of the used excipients? excipients used in product.
Do you have test reports and other records on Yes, the firm has test reports and other record of the excipients
13.
the excipients used? used.
Do you have written and authorized protocols SOPs were available. Trial manufacturing record was also
14.
for the development of product? provided.
Have you performed Drug-excipient Drug-excipient compatibility studies were not performed.
15.
compatibility studies? Firm was advised to perform these studies.
Have you performed comparative dissolution Comparative dissolution studies have not been performed. Panel
16. studies? is of the view that dissolution testing is not mandatory for
dispersible tablets as per USP.
Do you have product development (R&D) Yes, firm has R&D department.
17.
section?
Do you have necessary equipment available in Yes, firm has necessary equipment available in product
18. product development section for development development section.
of the product?
Are the equipment in product development Yes, the equipment in product development section were
19.
section qualified? qualified. Equipment qualification protocols were available.
Do you have proper maintenance / calibration Yes, firm has a maintenance / calibration / re-qualification
20. / re-qualification program for the equipment program for the equipment used in PD section.
used in PD section?
Do you have qualified staff in product Yes, firm has qualified and trainedstaff in product development
development section with proper knowledge section.
21. and training in product development? Remarks: The panel advised the firm management to arrange
product development focused additional trainings for the staff in
R&D department.
Have you manufactured three stability batches Yes, firm has manufactured three stability trial batches for the
22.
for the stability studies of product as required? stability studies.
What was the criteria for fixing the batch size The criteria for fixing the Batch size of stability batches was
23.
of stability batches? based on the minimum capacity of production equipment.
Do you have complete record of production of Yes, firm has complete record of production of stability batches.
stability batches? However, it was noted that in first trial batch No. RKT-T1-16,
source of Rifampicin was Shenyang Antibiotic Manufacturer,
24.
China and in next two trials RKT-T1-17 and RKT-T2-17, source
of Rifampicin was LuoheNanjiecun Pharmaceutical Group
Pharmacy, China.
Do you have protocols for stability testing of Yes, firm has protocols for stability testing of stability batches.
25.
stability batches?
Do you have developed and validated the Existing validated methods for already registered products of
26. method for testing of stability batches? firm of same API combination were used but not verified for
this product.
Do you have method transfer studies in case Pharmacopoeial methods were used.
27. when the method of testing being used by your
Do you have documents confirming the Yes, firm has documents confirming the qualification of
qualification of equipment / instruments being equipment / instruments being used in the test and analysis of
28.
used in the test and analysis of API and the API and finished drug product.
finished drug?
Is your method of analysis stability Yes, method has beenadopted from IP.
29.
indicating?
Do your HPLC software is 21CFR compliant? Three HPLCs were used for analysis of stability batches. Two
30. HPLCs system were compliant and one was not compliant
during stability studies.
Audit trail was available for testing done on HPLC 10 and
Can you show Audit Trail reports on product HPLC 20. Majority testing was done on RD 003 HPLC
31.
testing? available in R&D department on which audit trail was not
activated during stability studies.
Do you have some remaining quantities of Yes remaining quantities of impurities are available. Stability
32. degradation products and stability batches? batches for accelerated studies have been discarded after
completion of studies.
Do you have commitment batches kept on No, commitment batches will be made after drug registration.
33.
stability testing?
Do you have valid calibration status for the Yes
34.
equipment used in production and analysis?
Is proper and continuous monitoring and Yes, monitoring and control was available for the stability
35.
controlavailable for stability chamber? chambers provided. Data logger had been provided.
Can related manufacturing area, equipment, Yes
36. personnel and utilities be rated as GMP
compliant?
CONCLUSION
Based on the documents reviewed, areas inspected and technical personnel met, and considering the findings of the
inspection, the observations made by panel of inspectorsare given in detail in the tabulated report given above for stability
studies that were conducted by the firm M/s SchazooZaka (Pvt.) Ltd., Kalalwala, 20-Km, Lahore Jaranwala Road, District
Sheikhupura, for Tablet RIFA 2 Junior Dispersible and RIFA 3 Junior Dispersible Tablet. Sample withdrawal dates from
stability chamber and analysis dates for each time point were also verified randomly.
Decision: Registration Board deferred the case of Rifa 2 Junior Dispersible tablet & Rifa 3 Junior Dispersible tablet,
for clarifications from the firm for using two source of API. i.e. Rifampicin , in the manuacturing of stability batches.

Applications submitted on CTD format
Registration Board in its 276th meeting decided that that till Amendments in Rule 26 of the Drugs (Licensing,
Registering and Advertising) Rules, 1976, applicants can submit registration application on CTD format (as
approved in 264th meeting of Registration Board) alongwith relevant existing forms (Form 5 / 5A / 5D / 5E) and
such applications will be processed on a separate new queue for CTD applications for improved regulatory
compliance.
Following application now has been submitted on Form 5 along with enclosures on CTD format, details of which
are presented here for consideration of Registration Board.
180. Name and address of manufacturer / Applicant M/s Wilsons’s Pharmaceuticals Plot No. 387-388, Sector I-9
Industrial area, Islamabad.
Brand Name +Dosage Form + Strength Wilpat tablets 400mg/100mg
Sofosbuvir …400mg
Velpatasvir….100mg
Pharmacological Group HCV nucleotide analogue NS5B Polymerase inhibitor
Type of Form Form-5
Me-too status Sovelget tablets 400mg/100mg of M/s Getz Pharma
remarks that firm was operating at very good level of GMP
compliance at the time of inspection.
Remarks of the Evaluator.  GMP of API manufacturer (Sofosbuvir) is not valid now.
 Reports of process validation have not been submitted.
 Drug excipient compatibility studies are not submitted.
 Working standard of Velpatasvir is not in pure as shown
by COA of working standard.
 3.2.S.3 in case of Velpatasvir is missing.
Following details have been submitted of Module 3 (Quality / CMC) for both above cited applications:
Contents of Module: 3 (Quality / CMC)

Sub- Data submitted
Module Section Contents
section
3 3.2.S DRUG SUBSTANCE Sofosbuvir
General Information Detail submitted for
i. Nomenclature
3.2.S.1
ii. Structure
iii. General properties
Manufacture Detail submitted for
i. Manufacturer(s)
3.2.S.2 ii. Description of Manufacturing Process and
Process Controls(control of critical steps is
missing in case of Velpatasvir)
Characterization Detail submitted for
i. Elucidation of Structure and other
3.2.S.3
Characteristics
ii. Impurities
Control of Drug Detail submitted for
Substance i. Specification
ii. Analytical Procedures
3.2.S.4
iii. Validation of Analytical Procedures & reports
iv. Batch Analyses
v. Justification of Specification
Reference Standards Detail submitted for Reference Standards
3.2.S.5 or Materials (API with COA is purchased from Wujiang Xiehe
pharmaceuticals Batch No. SF 20140720)
Container Closure Detail submitted for Container Closure System
3.2.S.6
System
Stability Detail submitted for Stability. (Test Method Protocols
3.2.S.7
& reports have been submitted)
3 3.2.S DRUG SUBSTANCE Velpatasvir
Detail submitted for
i. Nomenclature
3.2.S.1
ii. Structure
iii. General properties
3.2.S.2
i. Manufacturer(s)
ii. Brief description of Manufacturing Process
and Process Controls(Control of critical steps
is missing in case of Velpatasvir)
iii. Control of materials
Characterization Detail submitted for

i. Elucidation of Structure and other
3.2.S.3
Characteristics
ii. Impurities
Substance i. Specification
3.2.S.4
iii. Validation of Analytical Procedures & reports
iv. Batch Analyses
v. Justification of Specification
Reference Standards Detail submitted for Reference Standards
3.2.S.5
or Materials It is dispersion instead of pure form.
3.2.S.6
System
Stability Detail submitted for Stability.
3.2.S.7 3 month stability data of both accelerated & real time
of one batch of API is submitted
3.2.P DRUG PRODUCT
Description and Detail submitted for Composition of Drug Product
3.2.P.1 Composition of Drug
Product
Pharmaceutical Detail submitted for
3.2.P.2 Development Components of the Drug Product
Drug Product
i. Manufacturer(s)
ii. Batch Formula
iii. Description of Manufacturing Process and
3.2.P.3
Process Controls
iv. Controls of Critical Steps and Intermediates
Undertaking has been submitted for Process
validation
Control of Excipient Detail submitted for
i. Specifications
3.2.P.4
All excipients used are of Pharmacopoeal grades
Product i. Specification(s)
3.2.P.5 ii. Analytical Procedures
iii. Validation of Analytical Procedures (Protocol
& report have been submitted)
Reference Standards Detail submitted for Reference Standards or Materials
3.2.P.6
or Materials
3.2.P.7
System
Stability Following have been submitted:
i. Stability Summary and Conclusions
ii. Post-approval Stability Protocol and Stability
3.2.P.8
Commitment
iii. Stability Data (Only reports have been
submitted.)
 GMP of Sofosbuvir manufacturer i.e. Pharmagen is not valid now.
Firm has submitted valid GMP certificate of firm.
 Reports of process validation of drug product have not been submitted.
 Drug excipient compatibility studies of drug product are not submitted.
Ingredients of Wilpat Tablets 400mg/100mg and Epclusa Tablets (innovator brand) are same.
Formulation of Wilpat Tablets and detail of Epclusa ingeredients attached here.
No incompatibilities of excipients with drug substance observed till now as stability studies (long term)
are ongoing. Copy of hand book of excipients attached.
 Working standard of Velpatasvir is not in pure form rather it is Velpatasvir Copovidone dispersion as
evident by COA of working standard. Clarify/Justify.
COA of working standard or Velpatasvir Copovidone is mentioned in drug master file section
3.2.S.3.2 (open part) given by manufacturer Virupaksha Organics Limited.
While we have tested our drug product against pure Velpatasvir working standard. Detail of
Batch/Lot # VLP/RSO1/16. Velpatasvir working standard is already described under section 3.3.P.5.5
& 3.2.P.6.
We are submitted COA of working standard of Velpatasvir (Pure) Batch# VLP/RSO1/16 for
justification purpose.
 Under section 3.2.S.3 details of drug substance “Velpatasvir” is missing.
 Submit 6 month accelerated and real time stability studies for three batches of drug substance Velpatasvir
as only three month stability data of both accelerated & real time for one batch of API is submitted.
 Percentage purity of dug substance Velpatasvir is 98.5% as evident by COA of working standard but in
submitted raw data sheets of analytical method results are calculated using potency of working standard
100%.Clarify/justify.
Percentage purity of Velpatasvir Copovidone described in COA of velpatasvir Copovidone working
standard which is the part of Drug Master File (open part) given by manufacturer Virupaksha
Organics Limited in section 3.2.S.3.2 of drug master.
While percentage purity of velpatasvir (pure0 working standard is 99.5% as per COA against which
we have tested our product.
COA of working standard attached.
 COA of Sofosbuvir working standard is missing.
Drug Wilpat tablets 400mg/100mg
Name of Manufacturer M/s Wilsons’s Pharmaceuticals Plot No. 387-388, Sector I-9 Industrial area,
Islamabad.
Manufacturer of API Sofosbuvir: M/s Pharmagen.
Velpatasvir (Copovidone): M/s ViruPaksha Organics Limited.
API Lot No. Sofosbuvir: COA of Sofosbuvir (Batch. # 00511211/001/2017 from M/s
Pharmagen
Velpatasvir (Copovidone): i. Velpatasvir Copovidone 1: 1(Batch. #
10604920170401) from M/s ViruPaksha Organics Limited.
Description of Pack
14’s, 28’s: Alu-Alu blister pack
Frequency Accelerated: Initial, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 (week)
Real Time: Initial, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 (week)
Batch No. Trial # 01 Trial # 01 Trial # 01
No. of Batches 03
Date of Submission Dy. No.3492; 26-01-2018
1. COA of API Yes
2. Approval of API by regulatory authority of country of Sofosbuvir: Firm has submitted copy of GMP
origin or GMP certificate of API manufacturer issued certificate of M/s Pharmagen issued by DRAP.
by regulatory authority of country of origin. Velpatasvir (Copovidone): firm has submitted
copy of GMP certificate issued to M/s Virupaksha
Organics Ltd by DCA Government of Telangana,
India.
Yes
respective documents like chromatograms, laboratory Yes
Yes

documents.
Yes
Yes
1978.
Data for exemption from Onsite investigation of submitted stability data
inspection for instant dosage form “Saferon (Sofosbuvir 400mg) Tablets”, which was
conducted during last two years. conducted on 19th April, 2017 and was presented in 278th
meeting of Registration board. Registration Board decided
to approve registration of Saferon (Sofosbuvir 400mg)
Tablets” by M/s. Wilson Pharmaceuticals Islamabad.
According to the report following points were confirmed.
 The firm has 21 CFR compliant HPLC software
 The firm has audit trail reports available.
 The firm possesses stability chambers with digital data
loggers.
2. Documents for the procurement of API Firm has submitted following documents.
with approval from DRAP (in case of  Copy of commercial invoice for Velpatasvir Co-povidone,
import). attested by AD (I&E), DRAP Islamabad on 05-06-2017 for
750 gram.
 Copy of invoice for Sofosbuvir dated 11-04-2017 for 3kgs.
3. Documents for the procurement of  Firm has not submitted any evidence for
reference standard and impurity procurement of reference standards and
standards. impurity standards.
However firm has submitted following:
COA of Velpatasvir & Sofosbuvir.
 Clarification is required for remarks written on
COA of Sofosbuvir working standard.
 Firm has submitted two COA for impurity
standards by Ruyuan HEC, one is in Chinese and
not understandable, firm has used working
standards of Ruyuan HEC and APIs are
purchased from other source.
4. Approval of API/ DML/GMP Firm has submitted following:
certificate of API manufacturer issued i. Copy of GMP certificate issued to M/s Virupaksha
by regulatory authority of country of Organics Ltd by CDA Maharashtra State,
origin. Telangana, India.
ii. Copy of GMP Certificate issued to M/s Pharmagen
by DRAP valid upto n10-08-2018.
5. Mechanism for Vendor pre- Firm has submitted following:
qualification i. Work instructions for evaluation of suppliers and
vendors.
6. Certificate of analysis of the API, Firm has submitted following:
reference standards and impurity i. COA of Velpatasvir Copovidone 1: 1(Batch. #
standards. 10604920170401) from M/s ViruPaksha Organics
Limited along with COA of working standard.
ii. COA of Sofosbuvir (Batch. # 00511211/001/2017
from M/s Pharmagen & COA of working standard.
 The Impurity standard from HEC RUYUAN is
used while the API & working standards were
purchased from M/s ViruPaksha & M/s
Pharmagen.
7. Documents for the procurement of Yes
excipients used in product
development?
8. List of qualified staff involved in Firm has provided list of technical staff comprising of nine
product development with relevant personals directly supervising product development section
experience.
Production Data
9. Authorized Protocols/SOP for the Firm has provided authorized protocols/SOPs for the
development & stability testing of trial development & testing of trial batches.
batches.  Date of issue & effective date, revision date is not
mentioned on protocols.
10. Complete batch manufacturing record Firm has provided Batch Manufacturing Record, including
of three stability batches. Master formulation, Raw material requisition sheets & batch
processing record sheets for all three batches.
11. Record of remaining quantities of Firm has provided following:
stability batches. Consumption record for stability studies of all three trial
batches. According to provided data firm has prepared 1200
tablets for each trial. 1050 were packed, 32 tablets were used
for initial testing, and 350 tablets were consumed in
accelerated stability testing & 668 in real time stability
testing.
 Now there is no any remaining quantity of trail
batch & how will the firm continue real time
stability studies till assigned shelf life of the
product.
QA/QC DATA
12. Record of Digital data logger for Firm has submitted following:
temperature and humidity monitoring i. Printed signed sheets for temperature & humidity
of stability chambers (real time and record of Accelerated & real time conditions for the
accelerated) time period of January January 2017 to 31st march
2018.
 Temperature and humidity data of 31st march
2017 is provided instead of 31st march 2018 in
accelerated stability studies. Clarification is
required.
13. Method used for analysis of API along Firm has submitted following documents
with COA.  COA for Velpatasvir copovidone from M/s
ViruPaksha Organics Limited
 COA for Sofosbuvir from M/s Pharmagen.
 In-house method for testing of Sofosbuvir and
Velpatasvir- copovidone.
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 i. Method of analysis (In-house)
reports, raw data sheets etc.)  Method validation is not carried out as
per ICH Q2 guidelines.
ii. Lab reports
iii. Raw data sheets
iv. HPLC Chromatograms (for Assay analysis) & for
Dissolution analysis)
However, Firm has not calculated the assay and
dissolution results of submitted stability studies as per
formula given in USP.
15. Reports of stability studies of API from Firm has submitted six month both accelerated (40°C ± 2°C
manufacturer. & 75±5%RH) stability studies & long term (30°C ± 2°C &
65±5%RH) stability studies reports of three batches of
Velpatasvir co povidone from M/s M/s ViruPaksha.
 Submit complete stability data both accelerated
& real time in case of Sofosbuvir for batch #
001/2015, 002/2015, 003/2015.
16. Analysis reports for excipients used. Firm has submitted analysis reports for following excipients
 Crosscarmellose sodium(COA)
 Avicel pH 200(COA)
 Titanium dioxide (COA)
 Mg. stearate (COA)
 Pharmacoat(HPMC)
 Iso propyl alcohol
The analysis reports for following excipients are not
provided.
 Microcrystalline cellulose
17. Drug-excipients compatibility studies. Firm has not performed drug excipient compatibility studies
rather it is submitted by the firm that ingredients of Wilpat
400mg/100mg & Epclusa tablets( Innovator brand) are same
so no incompatibilities of excipients with drug substance
observed till now as stability studies are on-going.
18. Record of comparative dissolution  Firm has submitted Comparative dissolution study
data. sheets. The details of reference product & Sample
product are as follows:
product Wilson
Pharmaceuticals
Brand name Velpanat Wilpat tablets
Tablets
Batch No. 1900588 Trail #1
Mfg. date 06-2017 05-2017
Expiry date 05-2019 04-2019
 Comparative dissolution study has been performed in
following mediums:
i. pH 5.0 Buffer (Acetate buffer with Cetyltrimethyl
ammonium bromide (CTAB)
ii. pH 6.8 Buffer
iii. pH 1.2 buffer
 Dissolution testing is performed at 5, 10, 15 & 30 mins.
 Remarks written under CDP sheets that “drug
release profile dos not comply with specifications but
it complies with innovator” what does it mean??
 Evidence of purchase of reference product is also not
provided.
19. Compliance Record of HPLC software Firm has submitted audit trail reports for HPLC analysis for
21CFR & audit trail reports on product all the three batches.
testing.
 Evidence for procurement of reference standards and impurity standards.
 Clarification is required for remarks written on COA of Sofosbuvir working standard.
 As evident by reconciliation sheets firm has no any remaining quantity of three trail batches than how
will the firm continue real time stability studies till assigned shelf life of the product. Justify/clarify.
 Temperature and humidity data of 31st march 2017 is provided instead of 31st march 2018 in
accelerated stability studies. Clarification is required.
 Firm is using in-house analytical method for analysis of finished product but analytical Method
validation is not carried out as per ICH Q2 guidelines. Justify/clarify.
 Justify how assay and dissolution results are calculated by this formula (peak area of sample/peak area
of standard ×100) without considering the potency of working standards.
 Submit complete stability data both accelerated & real time in case of Sofosbuvir for batch # 001/2015,
002/2015, 003/2015.
 Remarks written under CDP sheets that “drug release profile dos not comply with specifications but it
complies with innovator” what does it mean?? clarify
 Evidence of purchase of reference product is also not provided.
 COA of Impurity standard from HEC RUYUAN are submitted while the API & working standards
were purchased from M/s ViruPaksha & M/s Pharmagen. Justify/clarify.
 Analytical report of microcrystalline cellulose excipient has not been submitted.
Queries: Reply by the firm
Evidence for procurement of reference standards Working standard and impurity standard are received along
and impurity standards. with API including COA from the manufacturer. Therefore
no separate invoices for the working standard and impurity
standards, available.
COA of working standards and impurity standard attached.
Clarification is required for remarks written on Remarks: Nantong Chanyoo Pharmatech Co, Ltd.B # WS
COA of Sofosbuvir working standard. 201506001 CAS No.1190307-88-0. The remarks are
refrence no. of working standard stated by supplier for his
own identity.
As evident by reconciliation sheets firm has no We have performed 6 months accelerated abd real time
any remaining quantity of three trail batches stability studies. The real time stablility studies up to the
than how will the firm continue real time assigned shelf life will be continued as per ICH guidelines.
stability studies till assigned shelf life of the According to the guidelines upon submission of file
product. Justify/clarify remaining four intervals were, i.e. 9 Months, 12 months, 18
months, and 24 months. Moreover, for each interval 32
tablets were required for the testing, which implies a total of
128 tablets for 4 intervals. To perform real time stability
studies remaining quantities were 324 tablets from trial 1,
368 tablets from trial 2 and 368 tablets from trial 3.
st
Temperature and humidity data of 31 march We have submitted our temperature and humidity log from
2017 is provided instead of 31st march 2018 in 1st January 2017 to 31st March 2018.
accelerated stability studies. Clarification is The accelerated stability study was conducted from 29th
required. June 2017 to 12th January 2018.
Firm is using in-house analytical method for Method validation has been carried out as per ICHQ2
analysis of finished product but analytical guideline.
method validation is not carried out as per ICH
Q2 guidelines. Justify/clarify.
Justify how assay and dissolution results are • The combination of Sofosbuvir and Velpatasvir is
calculated by this formula (peak area of not mentioned in USP official monograph, General formula
sample/peak area of standard ×100) without for calculation of percentage.
considering the potency of working standards. Assay of finished pharmaceutical product by USP is written
as:
(ru/rs)x(Cs/Cu)x10
ru=peak response of the sample solution
rs= peak response of the standard solution
cu= nominal concentration in sample solution (mg/ml)
cs= nominal concentration in standard solution(mg/ml)
• As per our method of analysis final concentration of
sample and standard solutions are equal which will be
cancelled out that is why we are calculating the assay and
dissolution results given by formula written as:
(Peak area of sample/Peak area of standard) x100.
• In USP official monograph results can also
calculated by using formula:
Results=(ru/rr)x100
USP official monograph reference attached as annexure 06.
Submit complete stability data both accelerated • Stability data of sofosbuvir both accelerated & real
& real time in case of Sofosbuvir for batch # time for batch # 001/2015, 002/2015, 003/2015 attached as
001/2015, 002/2015, 003/2015. annexure 07.
Remarks written under CDP sheets that “drug • As per the specifications, release limit for
release profile dos not comply with dissolution in NLT 75% for both activities.
specifications but it complies with innovator” • Moreover, comparative dissolution studies were
carried out in four mediums:
what does it mean?? clarify
1. Acetate buffer Ph 4.5
2. 0.1 n hcl Ph 1.2
3. Phosphate Buffer Ph 6.8
4. Acetate buffer Ph 5.0 WITH ctab
• In above three mediums, dissolution profile of our
finished product Wilpat Tablets and reference product
Velpanat Tablets did not comply with the release limits,
while in Acetate buffer Ph 5.0 with CTAB, dissolution
profile of our finished product Wilapat Tablets and reference
product Velpanat Tablets complies with the release limit.
• However, the dissolution profile for both products
was found similar in all four mediums.
Evidence of purchase of reference product is also • Primary and secondary packaging of reference
not provided. product.
COA of Impurity standard from HEC RUYUAN • The impurity standard not purchased separately.
are submitted while the API & working They are provided by supplier M/s Pharmagen Limited
standards were purchased from M/s ViruPaksha Lahore along with API (Sofosbuvir).
& M/s Pharmagen. Justify/clarify.
• COA of impurity standard are attached
Analytical report of microcrystalline cellulose • We have already submitted analytical report of
excipient has not been submitted. Microcystalline Cellulose.
Decision:
Registration Board decided to approve registration of “Wilpat 400mg/100 tablets (sofosbuvir plus
velpatasvir 400mg/100mg) by M/s Wilson Pharmaceuticals. Manufacturer will place first three
accelerated studies for six months.
181. Name and Address of Manufacturer / M/s Newton Health Care Pvt Ltd.
Applicant Plot No: N -8&9, Hub Balochistan.
Brand Name + Dosage Form + Strength Iroton Tablets 100mg
Diary No. Date of R & I & fee Diary No:12122, 16-08-2017 , Rs: 20,000/- (Duplicate.
Challan #0706402)
Composition Each chewable tablet contains:
Iron (III) hydroxide polymaltose complex eq. to elemental
iron ….100mg
Pharmacological Group Antianemia drugs
Type of Form Form-5
Approval Status of Product in Reference N/A
Me-too Status Rubifer-F Chewable Tablets 100mg by M/s Ali Gohar
Pharmaceuticals (Pvt) Ltd (Reg#028121)
GMP Status 23-04-2018; Routine GMP inspection
Firm is currently operating at good level of GMP
compliance.
Remarks of the Evaluator.  Duplicate fee challan submitted by the firm.
Decision: Approved wiith 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
Following products (Dripsol 20% infusion (500ml), Dripsol-25% infusion (1000ml), Paksol-Paed(), Paksol 10%
Injection () ) of M/s Enterprises Ltd were registered products having Registration # 026826 , 026827, 017522 &
017525). Registration letters for these Products were issued with one pack size as per prevalent practice for
parenteral preparations.
However, in 265th meeting of Registration Board, M/s Frontier Dextrose Ltd., Haripur was granted separate
registrations for additional volume of their already registered products on submission of fee and separate
applications for registration, under directives of the Islamabad High Court order dated 11-11-2016. Now M.S.
Enterprises Ltd. Kasur, have requested for grant of separate volume/pack size of their following already Registered
products on the same account.
182. Name and address of Manufacturer / M.S. Enterprises Ltd.
Applicant 3.5km Raiwind Kot Radha kishan Road, kasur"
Brand Name + Dosage Form + Strength Paksole Peads Infusion100ml
Dextrose anhydrous…4.3gm
Sodium chloride… 0.18gm
Diary No. Date of R&I & fee DyNo. 22160; 26-06-18: 20,000
Pharmacological Group Crystalloid solution with carbohydrate source
Type of Form Form-5
Pack Size & Demanded Price 100ml; As per SRO
Me-too status Pladexal 1/5(500ml) of Otsuka Pakistan(drug infosis)
GMP status GMP inspection conducted on 12th June 2017 with
satisfactory remarks
Remarks of Evaluator Registration of applied formulation in another volume with
the name of Applicant M.S. Enterprises Ltd. has not been
verified from available record.
authorities/agencies as adopted by Registration Board
Applicant 3.5km Raiwind Kot Radha kishan Road, kasur
Brand Name+DosageForm+Strength Dripsol 25 % Infusion100ml
Dextrose anhydrous(as monohydrate)…25gm
Diary No. Date of R&I & fee Duplicate dossier
Pharmacological Group Hypotonic water and carbohydrate source.
Type of Form Form-5
Me-too status Dexsol 25% Infusion(20ml) of Vision Pharma
Remarks of Evaluator Evidence of approval status of applied formulation in
reference agencies is required.
Decision: Deferred for evidence of approval of applied formulation in applied strength in reference
regulatory authorities/agencies which were adopted by the Registration Board in its 275th meeting.
Brand Name+DosageForm+Strength Dripsol 20 % Infusion100ml
Mannitol….17.5gm
Sorbitol…..2.5gm
Type of Form Form-5
Me-too status Osmotol 20% Infusion(500ml) of Vision Pharma
Remarks of Evaluator Evidence of approval status of applied formulation in
reference agencies is required.
Brand Name+DosageForm+Strength Paksol 10 % Infusion100ml
Dextrose anhydrous(as monohydrate)…10gm
Type of Form Form-5
Pack Size & Demanded Price 100ml; As per SRO or Rs. 50/-
Approval status of product in Reference Approved in MHRA(100ml)
Me-too status Pladexal of Otsuka Pakistan(drug infosis)
Remarks of Evaluator Me Too is not available in applied volume i.e. 100ml
Registration of applied formulation in another volume with
the name of Applicant M.S. Enterprises Ltd. has not been
verified from available record.
Decision: Deferred for evidence of applied formulation/drug in applied volume i.e. 100ml already approved
by DRAP (generic / me-too status) alongwith registration number, brand name and name of firm.
Case No. 08 Export Facilitation cases
Export Facilitation: Applications was received through letter No.F.7-7/2017-Reg-II (Vol-I)

“M/s Indus Pharma, Karachi have achieved benchmark OF usd 500,000 as defined in the Board’s
decision during fiscal year 2016-2017. In this regard, please find the (5 molecule) applications
submitted by the firm.”
186. Name and address of manufacturer / M/S Indus Pharma (Pvt) Ltd. Plot No. 26, 27, Korangi
Applicant Industrial Area Karachi.
Brand Name +Dosage Form + Strength Indaz 200mg/5ml Powder for oral suspension
Azithromycin (as dihydrate)…200mg
Type of Form Form 5
Pack size & Demanded Price 15ml ; As per SRO
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 (with strength and Azomax Dry Suspension by M/s Novartis (Reg#022201),
dosage form)
GMP status Last inspection was conducted on 11-06-2018 and report
concludes that firm was considered to be operating at an
acceptable level of GMP compliance
Decision: Approved.
Brand Name +Dosage Form + Strength Indaz 500mg Tablet
Azithromycin as (dihydrate)………..500 mg
Type of Form Form 5
Pack size & Demanded Price 6’s, RS; 78.43/tablet, RS; 470.58/Pack
Approval status of product in Zaraxin tablet of (MHRA approved)
Me-too status (with strength and Azic 500mg Tablet by M/s Nabi Qasim
dosage form)
Decision: Approved.
Brand Name +Dosage Form + Strength Xed 650mg Tablet
Tranexamic acid………..650 mg
Diary No. Date of R& I & fee Dy.No. Duplicate Dossier; 01-06-2017; Rs.50,000/- (01-06-
2017)
Pharmacological Group Anti fibronyltic
Pack size & Demanded Price 10’s, 30’s bottle As per DPC
Approval status of product in Lysteda of (USFDA approved)
dosage form)
Remarks of the Evaluator Submitt stability studied
the requirements of 278th meeting of Registration Board
Contract manufactured by: M/S Nabiqasim Industries (Pvt)
Ltd., 17/24, Korangi , Industrial Area, Karachi, Pakistan
Brand Name +Dosage Form + Strength Cidpro 40mg IV Injection
……….40mg
Diary No. Date of R& I & fee Dy.No. Duplicate dossier; 22-09-2017; zRs.50,000/- (21-09-
2017)
Type of Form Form 5
Approval status of product in Omeprazol 40mg injection of (MHRA approved)
Me-too status (with strength and Fymezole Dry Powder Injection IV of M/s Fynk
GMP status Last inspection of Indus pharma was conducted on 11-06-
2018 and report concludes that firm was considered to
be operating at an acceptable level of GMP compliance
&
Last GMP of Nabi qasim Inspection conducted on 02-
11-2017 and report concludes that firm is found good
level of GMP compliance.(PSI)
Remarks of the Evaluator No of sections;08
Already contract registred products :Nil
challan and Board authorized its Chairman for the issuance of registration letter
Contract manufactured by
M/S Nabiqasim Industries (Pvt) Ltd., 17/24, Korangi ,
Industrial Area, Karachi, Pakistan
Brand Name +Dosage Form + Strength Nixpro 40mg IV Injection
Pantoprazole Sodium (U.S.P) equivalent to Pantoprazole
……….40mg
Diary No. Date of R& I & fee Dy.No. Duplicate dossier; 22-09-2017; Rs.50,000/- (21-09-
2017)
Type of Form Form 5
Approval status of product in Protonix injection of (USFDA approved)
Me-too status (with strength and Pazole Dry Powder Injection IV of M/s Fynk
dosage form) Pharmaceuticals,
&
Brand Name +Dosage Form + Strength Indazole 20mg IV Injection
……….20mg
2017)
Type of Form Form 5
Me-too status (with strength and ES-Loprot 20mg I.V Injection of M/s Nabiqasim
dosage form)
2018 and report concludes that firm was considered to be
operating at an acceptable level of GMP compliance
&
Brand Name +Dosage Form + Strength Indazole 40mg IV Injection
……….40mg
2017)
Type of Form Form 5
Me-too status (with strength and Esold Injection of M/s Weather Folds Pharmaceutical
dosage form)
&
C. Registration-I
Case.No.01:- Requests for Cancellation/Withdrawal of Registration Applications.

The following firms has requested for cancellation / withdrawal of registration applications of their
products which were approved in different Registration Board meetings as per details mentioned
below:
S.No Firm Name/importer Product name & Demanded Board Reason for
Composition Pack Size & Decision/Remarks cancellation/wit
MRP hdrawal stated
by firm
1. M/s. Cherry Impex Tyloral Powder for 100 mg Approved as per “Due to some
International, Oral Solution sachet, 100mg Import Policy for unavoidable
14-E, 1st Floor, Punjab Each sachet/ pot pot, 1 kg jar Finished Drugs circumstances
Cooperative Housing contains: with innovator’s we are not
Society, Lahore Cantt Tylosin (as specifications. interested to
Manufacturer: tratrate)……….100,0 market/import
M/s. Qalian, 34 RUE 00,000 IU M-277 this product”
JEAN MONNET Z.I.d,
Etriche- 49500 Segre (For poultry)
France
2. M/s B. Braun Pakistan ONDANSETRON B. Rs. 905/- Pack Approved. “we hereby
(Pvt) Limited, The Braun 2mg/ml of 1’s (4ml withdraw our
Forum Suite 216, (Solution for plastic M-257 registration
Khayaban-e-Jami, injection/infusion) ampoule) application of
Clifton Block -9 imported drug
Karachi. Each ml contains: Ondansetron B.
Manufacturer:- Ondansetron Braun 2mg/ml
M/s B. Braun Hydrochloride eq. to due to certain
Melsungen AG, Carl – Ondansetron……..2 reasons”
Braun-Str.134 212 mg
Melsungen, Germany.
Antiemetic, anti
nauseant, Serotonin
5HT3 antagonist
3. M/s Oncogene Anaskebir 1mg Film Rs. 4000/- per Approved with USP “Its been a span
Pharmaceuticals, 246/B, Coated Tablet pack specifications as per of almost 6 years
Mezzanine floor Each film coated 28’s import Policy during which the
P.E.C.H.S, Block-6. tablet contains:- market dynamics
Manufacturer:- Anastrozole……1mg M-274 and pricing
1. M/s Laboratories factors have
Blipack S.A.- Tres remarkably
Arroyos No 329, UF 43, changed. The
Parque Industrial La company has
Cantabrica Haedo now marked the
2. M/s Craveri S.A.I.C- launch of above
Arengreen No 830, mentioned
Ciudad Autonoma de products as non-
Buenos Aires. feasible so we
3. M/s Laboratorio are not
Eczane Pharma S.A.- interested to
Laprida 43, Avellaneda- proceed with it.
Prov-Buenos Aires
4. -do- Kebirzol 2.5mg Film Rs. 5000/- per Approved with USP -do-
Coated Tablets pack specifications as per
Each film coated 30’s Import Policy for
tablet contains: Finished Drugs. Fee
Letrozole……2.5mg shall be verified as
per procedure
adopted in 264th
meeting
M-274
Decision:- Registration Board acceded to above mentioned requests of firm and accordingly
disposed off the registration applications.
Case.No.02:- Request of M/s. Chiesi Pharmaceuticals (Pvt) Ltd, Lahore for De-registration of
their Registered product
M/s. Chiesi Pharmaceuticals (Pvt) Ltd, Lahore has requested for de-registration of following
registered product as per details mentioned alongside.
Alternative
Product Name registered product
S.No Firm Name Reg. No Reason for De-Reg
and Composition (Provided by the
firm)
1. M/s Chiesi Rino Clenil 009788 Rino Clenil 50mcg i. Gnadion
Pharmaceuticals 50mcg nasal spray Nasal Spray was Importer M/s Mehran
(Pvt) Ltd, Each dose registered in Pakistan Traders.
Lahore. delivers 50mcg of on 10th May, 1988 for Reg. No. 016826
Manufacturer:- the active indications of treatment (Beclomethasone
M/s. Chiesi substance of Rhinitis. Its dipropionate.. 50mcg)
Pharmaceutici, Beclomethasone registration is being
Pharma Italy. dipropionate…… withdrawn because of ii. Beclo Rino
0.010g its manufacturing in the M/s Genesis Pharma.
country of origin i.e. Reg. No. 018946
Parma, Italy, has been (Beclomethasone
dismantled as this dipropionate…1mg)
product is of no more
interest in the Country
of Origin.
The firm has submitted the following supporting documents:
a. Application.
b. Copy of initial registration letter and renewal status.
c. Justification. (mentioned in above table)
d. List of alternative brands available in the country. (mentioned in above table)
e. An undertaking that no case is pending at any forum/court of law regarding this
product.
Decision:- Registration Board deferred firm’s request for obtaining details regarding
alternate source of manufacturing of product Rino Clenil 50mcg nasal spray
(Reg.No. 009788).
Case.No.03:- Minutes of Expert Working Group on Veterinary drugs
Registration Board in its 281st meeting held on 11-13th April, 2018 constituted an Expert
Working Group on veterinary drugs for provision of expert opinion and recommendations to the
Registration Board on matters relating to veterinary drugs referred to it by the Board including review
of existing/new veterinary drug formulations.
So far two meetings of the said Expert Working Group has been conducted. Minutes are as
follow for consideration of Registration Board.
I. Minutes of 1st Expert Working Group on Veterinary Drugs held on 22nd May, 2018
The first meeting of expert working group on veterinary drugs was held on 22nd May, 2018 in
the Committee Room of DRAP 4th Floor TF Complex, Islamabad. Dr. Qurban Ali, Member
Registration Board chaired the meeting which is also attended by the followings: -
(i) Dr. Muhammad Akram
Representative of Animal Husbandry Commissioner
Ministry of National Food Security & Research,
Islamabad.
(ii) Dr. Mazhar-ul-Haq,

Veterinary Pharmacologist,
Arid Agriculture University,
Rawalpindi.
(iii) Zaheer ud Din M. Babar,

Deputy Director (Reg-I)/Secretary Expert Working Group
DRAP, Islamabad.
Mr. Syed Adnan Ali Shah, Assistant Director (Reg-I) DRAP, Islamabad assisted the Working
Group. The Chairman welcome the participants and give a brief background regarding the objective of
constitution of the working group. The agenda items are taken up as per following details: -
Item No.I Recommendation of Commission constituted by Supreme Court of Pakistan for

Probing the quality issues of Poultry feeds, poultry farms and poultry meats
forwarded by Government of Punjab Referred by Registration Board.
Section officer (I&C), Livestock & Dairy Development Department, Punjab has
informed that August Supreme Court of Pakistan constituted a commission for the purpose of
addressing quality assurance in SUO MOTO Civil Petition No. 2374-L of 2016, case of regulatory
control of poultry sector (including poultry feed, poultry farms and poultry meat).
The Commission has submitted its recommendation, one of which relating to Antibiotic Growth
Promoter (AGP) is as under:
a. There should be proper registration of the manufacture, import and sale of
AGPs under the existing drug laws or law specific to AGPs in Pakistan.
Keeping in view the above mentioned recommendation, Livestock & Dairy Development
Department of Govt. of Punjab notified (vide Notification No.SO(I&C)/L&DD/6-66/78/2012)
following two lists of “Antibiotic Growth Promoters” i.e Positive List (Permissible) and negative list
(impermissible) as feed stuff to be used as feed additives.
i. Positive List:
Flavomycin, Enramycin and Avilamycin are considered safe AGPs since these are not used in
human. Flavomycin and Avilamycin have no residual effects. However Enramycin shall only
be used in Broiler starter, Broiler Grower, Layer Starter and Layer Grower feeds. However use
of Virginiamycin, Bacitracin (Zinc Bacitracin & Bacitracin Methylene Disalicylate) and
Lincomycin as AGPs are questionable on account of their use in human although they have
negligible residual effects. Whereas these shall be regularly examined through indigenous
research for anti-microbial resistance (AMR) in human and in case of AMR these AGPs will
be periodically replaced with alternate herbal, organic acids and other research based products.
ii. Negative List:
In view of the best practices, use of Colistin, Ciprofloxacin, Vancomycin, Avopasin,
Oliquindox, Carbadox, Furaltadone, Roxarsone and other therapeutic antibiotics in livestock
and poultry feed as feed additive / antibiotic growth promoters are strictly banned due to their
use in human, long withdrawal periods and other negative effects.
iii. The maximum quantity of AGPs allowed in poultry feed are prescribed as under:-
S.No. Active Ingredient Maximum dosage in Feed
1. Lincomycin 4.4 PPM
2. Enramycin 10 PPM
3. Zinc Bacitracin 50 PPM
4. Bacitracin Methylene Disalicylate 50 PPM
5. Virginiamycin 20 PPM
6. Avilamycin 30 PPM
7. Flavomycine (Bambercin) 12 PPM
AGP at Sr. No. 2 shall only be used in Broiler starter, Broiler Grower, Layer Starter, Layer
Grower feeds.
Working Group reviewed the Notification issued by the Livestock & Dairy Development
Department Government of Punjab. Particularly the rationality of use of antibiotics as growth
promoters was deliberated in detail. It was noted that antibiotics are some time used in
sub-therapeutic doses through feed as growth promoters but this practice is not common. The feed
premixes containing antibiotics are generally mixed with feed either at the time of feed formulation or
at the time of feeding animals. The primary use of antibiotics in veterinary practices is therapeutic and
preventive while their use as growth promoter is very limited. The import, manufacture and sale of
formulation containing antibiotics for veterinary use is regulated under Drugs Act, 1976. However,
their use as growth promoters needs to be reviewed in consultation with stake holders.
It was decided that Dr. Mazhar-ul-Haq will prepare a position paper on the use and regulation
of antibiotic as growth promoters in the light of the Notification issued by the Livestock & Dairy
Development Department Government of Punjab for further consideration by the stake holders.
ITEM NO. II POLICY GUIDELINES REGARDING REFERENCE REGULATORY

AUTHORITIES FOR REGISTRATION OF VETERINARY DRUGS.
The following policy guideline has been approved by the Registration Board for registration of
drugs in general:-
(i) The molecules/ formulations (in same dosage form and strength) alongwith clinical trials
registered by drug regulatory agencies of USFDA, Health Canada, EMA, TGA Australia
and PMDA Japan, United Kingdom, Germany, France, Switzerland, Netherlands, Austria,
Denmark, Sweden and Norway or drugs registered in at least three European Union
counties will also be taken as reference for consideration of Registration Board, as
authorities of these countries have robust drug regulatory mechanisms and long standing
strong litigation systems. However Registration Board shall also consider the safety and
efficacy parameters of the drug under domestic circumstances / practices.
(ii) If an imported drug is not on free sale in its respective country of origin / manufacture,
such product will be registered in Pakistan if the 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. However, references countries regarding availability of drug / molecule /
formulation shall remain the same as specified at (i) above.
(iii) Registration Board in its 275th meeting discussed the matter in detail and decided that in
addition to already approved reference regulatory authorities, another (7) regulatory
authorities i.e., regulatory authority of Belgium, Finland, Italy, Ireland, Iceland, Spain and
WHO prequalified formulation shall also be considered as reference. Thus Registration
Board decided to consider following regulatory authorities / agencies as reference for
molecules/ formulations (in same dosage form and strength) alongwith clinical trials for
human purpose.
(i) Food & Drug Administration (FDA) of USA.

(ii) Health Canada of Canada.
(iii) Therapeutic Good Administration (TGA) of Australia.
(iv) Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.
(v) Medicines and Healthcare Regulatory Agency (MHRA) of UK.
(vi) National Agency for the Safety of Medicine and Health Products (ANSM) of France.
(vii) Federal Institute for Drugs and Medical Devices of Germany.
(viii) Medicines Evaluation Board of Netherland.
(ix) Swiss medic of Switzerland.
(x) Austrian Agency for Health and Food Safety of Austria.
(xi) Danish Medicines Agency of Denmark.
(xii) Medical Products Agency of Sweden.
(xiii) Norwegian Medicines Agency of Norway.
(xiv) Federal Agency for Medicines and Health Products of Belgium
(xv) Finnish Medicine Agency of Finland.
(xvi) Italian Medicine Agency (AIFA) of Italy.
(xvii) Health Products Regulatory Authority (HPRA) of Ireland.
(xviii) Icelandic Medicine Agency of Iceland.
(xix) Spanish Agency for Medicines and Health Products of Spain.
(xx) European Medicines Agency (EMA) of Europe and
(xxi) World Health Organization (WHO).
A number of registration applications of veterinary drugs are deferred for being not free sale in
any of the above reference countries. The stakeholder relating to veterinary drugs, with reference to
above policy guidelines, argues that the policy for human drugs cannot be implemented on veterinary
drugs as such, as these reference countries do not have huge animal population and diseases and
climatic conditions are different from countries having big animal population. The PPMA has given
following recommendations in this regard:-
1) Veterinary Drugs in many countries do not necessarily fall under Drug Regulatory Regime and
may be regulated and registered under Ministry of Health, Ministry of Agriculture and Dairy.
Ministry of Feed and Animal Resources.
2) We propose that, apart from 21 SRA countries Regulatory Authorities including WHO and
EMEA Agencies below highlighted 12 countries should also be included in the list of SRA
countries for Veterinary Drugs since these countries have similar Tropical, Hot and Humid
climate, Animal Species have similar diseases and Famer Practices are similar to Pakistan.
3) These countries have Databases available in Book form, Veterinary Doctor Guide books, and
some on the Web. Countries where such Databases are difficult to access then other methods
of obtaining such data should be exercised.
4) Single Ingredient Molecules with varying concentrations or strengths i.e 10%, 20%, 50% and
100% are developed by pharmaceutical companies to specific countries looking at species and
disease pattern which not necessarily may be present in these countries and regulated and
registered in country of origin and should be considered for registration in Pakistan irrespective
of International Availability of the above 30 countries. For example, TylosinTartrate 100%,
Amoxycillin 100% and Doxycycline 100% soluble powder for Poultry Ready to use Powder
are in Saudi Arabia exactly similar to Ready to Use Ceftriaxone ready to fill for injection for
treatment in Humans.Also such as Nitroxynil 34% of Norbrook UK and Triclabendazole of
Ciba Giegy for treatment of Liver flukes and Parasites along River beds in Africa and South
East Asia, Treatment of trypnomaisis disease in Camels only present in Desert and South East
Asia.
5) Only for combinations of molecules and dosage forms which are not present in the above 40
countries then those combinations shall be given to Expert Member and Veterinary Experts to
see the rationality of such drugs and once they approve then may be registered irrespective to
international availability and me-too status
6) It is also suggested that documents from OIC and FAO and Tropical Diseases should be
considered and system of India and South America, Korea, China and ASPEC Countries should
be taken into consideration.
7) Multi Antibiotic which includes 4 to 6 Antibiotics in Veterinary Drugs. It is suggested to
look in to matter to accept only “INTERNATIONALLY KNOWN SYNERGISTIC
COMBINATIONS”.
8) Following are the countries recommended for inclusion in SRA.
S. No. Name of Countries S. No. Name of Countries

1. Argentina 2. South Korea
3. Malaysia 4. New Zealand
5. Singapore 6. Thailand
7. Taiwan 8. Saudi Arabia
9. Turkey 10. Brazil
11. India 12. China
The working group deliberated the various proposals given by PPMA as under: -
i. The addition of more reference regulatory authority for the purpose of registration of veterinary
drugs required further deliberation and evaluation in order to ascertain that only those
regulatory authority shall be considered for inclusion, which qualifies the internationally
accepted criteria for being a stringent authority. It was further observed that veterinary drugs
regulatory authorities needs to be identified in those reference countries where veterinary drugs
are regulated by authorities different from the one which regulates human drugs
ii. For veterinary drug products which originate / manufactured in reference countries but are not
on free sale in country of origin or other reference countries as the disease for the treatment of
which these products are used, is / are not prevalent in these countries, the data regarding
prevalence of disease published by World Animal Health Organization (OIE) can be of help to
ascertain the factual position.
iii. For veterinary drugs molecules / formulations which are not approved in any reference
regulatory authority due to non prevalence of disease in those countries, the matter needs to be
evaluated on cases to case base in view of the internationally available data particularly in the
countries having similar conditions. This evaluation is to be done by a broad based working
group comprise of relevant experts and other stake holders including representatives of Federal
and Provincial Governments departments / organizations, research institutes / laboratories. For
this purpose a mechanism needs to be evolved in consultation with stake holders including
relevant Federal and Provincial Government Organizations and Research Institutions.
II. Minutes of 2nd Expert Working Group on Veterinary Drugs held on 5th June, 2018
The 2nd meeting of Expert Working Group on Veterinary Drugs was held on 5th June, 2018 in the
Committee Room of DRAP 4th Floor TF Complex, Islamabad. Dr. Qurban Ali, Member Registration
Board chaired the meeting which was also attended by the followings: -
(i) Dr. Muhammad Akram

Representative of Animal Husbandry Commissioner
Ministry of National Food Security & Research,
Islamabad.
(ii) Dr. Mazhar Ul Haq,

Veterinary Pharmacologist,
PMAS, Arid Agriculture University,
Rawalpindi.
(iii) Zaheeruddin M. Babar,

Deputy Director (Reg-I)/Secretary Expert Working Group
DRAP, Islamabad.
Dr. Muhammad Kashif Saleemi, Assistant Professor, University of Agriculture Faisalabad

attended on special invitation. Mr. Syed Adnan Ali Shah, Assistant Director (Reg-I) DRAP, Islamabad
assisted the Working Group.
Meeting started with recitation of Holy Quran. The Chairman welcomes the participants. Dr.
Muhammad Kashif Saleemi, Assistant Professor, University of Agriculture Faisalabad gave a brief
presentation on common poultry diseases in Pakistan and importance of the therapeutics agent used for
their treatment. The agenda items are taken up as per following details: -
ITEM NO.I CONFIRMATION OF MINUTES OF 1ST MEETING OF EXPERT

WORKING GROUP ON VETERINARY DRUGS.
The working group confirmed the minutes of 1st meeting without any change.
ITEM NO. II POLICY GUIDELINES REGARDING REFERENCE REGULATORY
AUTHORITIES FOR REGISTRATION OF VETERINARY DRUGS.
In 1st meeting the working group considered the recommendations of PPMA including the
one relating to registration applications of veterinary drugs deferred for being not free sale in any of
the reference countries. The working group deliberated the various proposals given by PPMA as
under:-
iv. The addition of more reference regulatory authority for the purpose of registration of veterinary
drugs required further deliberation and evaluation in order to ascertain that only that regulatory
authority shall be considered for inclusion,which qualifies the internationally accepted criteria
for being a stringent authority. It was further observed that veterinary drugs regulatory
authorities needs to be identified in those reference countries where veterinary drugs are
regulated by authorities different from the one which regulates human drugs.
v. For veterinary drug products which originate / manufactured in reference countries but are not
on free sale in country of origin or other reference countries as the disease for the treatment of
which these products are used, is / are not prevalent in these countries, the data regarding
prevalence of disease published by World Animal Health Organization (OIE) can be of help to
ascertain the factual position.
vi.
vii. For veterinary drugs molecules / formulations which are not approved in any reference
regulatory authority due to non prevalence of disease in those countries, the matter needs to be
evaluated on cases to case base in view of the internationally available data particularly in the
countries having similar conditions. This evaluation is to be done by a broad based working
group comprise of relevant experts and other stake holders including representatives of Federal
and Provincial Governments departments / organizations, research institutes / laboratories. For
this purpose a mechanism needs to be evolved in consultation with stake holders including
relevant Federal and Provincial Government Organizations and Research Institutions.
With reference to above discussion it was informed that the Registration Board in various
meetings referred various imported veterinary products to committee comprises of Dr. Qurban Ali,
Director General, NVL, Dr. Muhammad Arshad, PVMC Islamabad and DDC (R-I)for securitization /
verification of codal requirements. The Board also authorized Chairman Registration Board for taking
decision on recommendations of Expert Committee, subject to submission of balance fee as per revised
fee schedule, inspection of manufacturer abroad, where applicable, verification of storage facilities and
price fixation / calculation etc as per policy. The Committee/ Expert subsequently gave
recommendations for these products but their registrations are withheld for not being free sale in
country of origin. The details of such products considered in various meetings are given as under:-
(A) Following drugs were referred to Dr. Qurban Ali in 236th meeting of Registration Board who
evaluated and recommended as per details mentioned against each.
S. No. Name of Importer/ Name of Drug (s)/ Decontrolled/ Shelf Recommendat

Manufacturer Composition Approved Life ions
Pack Size(s)
1. M/s. Welldone Marketing Amcosul Injection 50ml 3 years Recommended
Lahore. / Each ml contains:- 100ml
M/s. Amoxycillin ………….100mg
FlorisVeterinaireProdukten Colistine Sulphate..2,50,000IU
B.V. Kempenlandstraat (Antibiotic / Bactericidal)
33,5262 GK Vught, The
Netherlands.
2. M/s. Welldone Marketing Flucosul Water Soluble 100gm 3 years Recommended
Lahore. / Powder 200gm
M/s. Each gm powder contains:- 500gm
FlorisVeterinaireProdukten Flumequine…………...200mg 1Kg
B.V. Kempenlandstraat ColistineSulphate…………1,2
33,5262 GK Vught, The 0,000 IU
Netherlands. (Antibiotic / Bactericidal)
3. M/s. Welldone Marketing Tycosine Water Soluble 100gm 3 years Recommended
FlorisVeterinaireProdukten Doxyciline HCL…..…200mg 1Kg
B.V. Kempenlandstraat Tylosine Tartrate…….100mg
33,5262 GK Vught, The Colistine Sulphate.540,000 IU
Netherlands. Bromhexine….50mg
(Antibiotic / Bactericidal)
4. M/s. Welldone Marketing Coliflor Powder 100gm 3 years Recommended
Lahore. / Each gm powder contains:- 200gm
M/s. ColistineSulphate……….5,00 500gm
FlorisVeterinaireProdukten 0,000 IU 1Kg
B.V. Kempenlandstraat (Antibiotic / Bactericidal)
33,5262 GK Vught, The
Netherlands.
5. M/s. Welldone Marketing Amcosul Water Soluble 100gm 3 years Recommended
FlorisVeterinaireProdukten Amoxicillin………..…230mg 1Kg
B.V. Kempenlandstraat ColistineSulphate………..1,00
33,5262 GK Vught, The 0,000 IU
Netherlands. (Antibiotic / Bactericidal)
6. M/s. Welldone Marketing Amoxycillin Injectable 50ml 3 years Recommended
Lahore. / Suspension 100ml
M/s. FIT Business Holland Each ml contains:-
BV Netherlands. Amoxycillin……..…150mg
7. M/s. Welldone Marketing AmoxycillinTrihydrate Water 100gm 3 years Recommended
Lahore. / Soluble Powder 200gm
M/s. FIT Business Holland Each gm contains:- 500gm
BV Netherlands. AmoxycillinTrihydrate……… 1Kg
…..250mg
8. M/s. Welldone Marketing Tycodox-3 WS Liquid 250ml 3 years Recommended
M/s. FIT Business Holland DoxycilineHCl….……200mg 1 Liter
BV Netherlands. Tylosine Tartrate…...…100mg
ColistineSulphate.2500,000IU
9. M/s. Ani Cure Veterinary Macrolan-200 Injection 100ml 3 years Recommended
Services, Rawalpindi. / Each ml contains:-
M/s. InterchemieWerken ”De Tylosin Base………...200mg
Adelaar” B.V. Metaalweg, (Antibacterial)
CG Venray, Holland.
10. M/s. Ani Cure Veterinary Penstrep 400 LA Injection 100ml 3 years Recommended
M/s. InterchemieWerken ”De BenzathinePencilline
Adelaar” B.V. Metaalweg, G……………........100,000IU
CG Venray, Holland. Procaine Penicillin
G………………….100,000IU
DihydrostreptomycinSulphate
……………….200mg
11. M/s. Ani Cure Veterinary Intracox Oral Liquid 1000ml 3 years Recommended
M/s. InterchemieWerken ”De Toltrazuril…………..25mg
Adelaar” B.V. Metaalweg, (Symmetric Triazinone)
CG Venray, Holland.
12. M/s. Ani Cure Veterinary Penstrep-400 Injection 100ml 2 years Recommended
M/s. InterchemieWerken ”De Procaine
Adelaar” B.V. Metaalweg, Benzylpenicillin…200,000IU
CG Venray, Holland. DihydrostreptomycinSulphate
……………..200mg
13. M/s. Ani Cure Veterinary Biocillin 150 LA Injection 100ml 2 years Recommended
M/s. InterchemieWerken ”De Amoxycillin base……..150mg
Adelaar” B.V.Metaalweg, CG
Venray, Holland.
14. M/s. Ani Cure Veterinary Intremectin Injection 50ml 3 years Recommended
M/s. InterchemieWerken ”De Ivermectin…………….10mg
Adelaar” B.V. Metaalweg,
CG Venray, Holland.
15. M/s. Ani Cure Veterinary Dimoxan Water Soluble 100gm 3 years Recommended
Services, Rawalpindi. / Powder 500gm
M/s. InterchemieWerken ”De Each gm contains:- 1000gm
Adelaar” B.V. Metaalweg, ColistinSulphate...1,200,000IU
CG Venray, Holland. AmoxycillinTyrihdrate………
……..200mg
16. M/s. Ani Cure Veterinary Interspectin-L Injection 100ml 3 years Recommended
M/s. InterchemieWerken ”De Lincomycin base as
Adelaar” B.V. Metaalweg, HCl…………………….50mg
CG Venray, Holland. Spectinomycin base as
HCl……………………100mg
17. M/s. Ani Cure Veterinary Coli-4800 Water Soluble 100gm 3 years Recommended
Services, Rawalpindi. / Powder 500gm
M/s. InterchemieWerken ”De Each gm contains:- 1000gm
Adelaar” B.V. Metaalweg, ColistinSulphate...............4,80
CG Venray, Holland. 0,000IU
(B) Following drugs were referred to Committee comprises of Dr. Qurban Ali, Director General,
NVL, Dr. Muhammad Arshad, PVMC Islamabad and DDC (R-I)in 237th meeting of Registration
Board which evaluated and recommended as per details mentioned against each.
S. No. Name of Importer/ Name of Drug (s)/Composition Approved Shelf Remarks
Manufacturer Pack Size(s) Life
1. M/s. Better Traders Tilmi 25% Oral Liquid 100ml 03 years Approved
International, Faisalabad. / Each ml contains:- 250ml
M/s. Kepro B.V. Tilmicosin (as Tilmicosin 500ml
Maagdenburgstraat, phosphate)……..…..…250mg 1 Liter
Deventer, Holland. (Anti-microbial drug). 2.5 Liter
5 Liter
2. M/s. Better Traders L.S. Water Soluble Powder 100g 03 years Approved
International, Faisalabad. / Each gm contains:- 150g
M/s. Kepro B.V. Lincomycin HCI……….222mg 1000g
Maagdenburgstraat, Spectinomycin HCI……444mg
Deventer, Holland. (Antibiotic)
3. M/s. Better Traders L.S. Injection 100ml 02 years Approved
International, Faisalabad. / Each gm contains:-
M/s. Kepro B.V. Lincomycin
Maagdenburgstraat, (as HCI H2O)……………50mg
Deventer, Holland. Spectinomycin
(as HCI 5 H2O)……..…100mg
(Antibiotic)
4. M/s. Better Traders Florum 10% Oral Solution 1000ml 03 years Approved
International, Faisalabad. / Each ml contains:-
M/s. Kepro B.V. Florfenicol…………..100mg
Maagdenburgstraat, Holland. (Synthetic Broad Spectrum
Antibiotic).
5. M/s. Fine Traders Agdoxytyl Water Soluble 100gm 03 years Approved
International, Powder 500gm
Faisalabad./ Each gram powder contains:- 1 Kg
M/s. AGRAR HOLLAND Doxycycline Hyclate…150mg/g 2.5 Kg
BV, Soest, Holland. Tylosin Tartrate………200mg/g 5 Kg
(Broad Spectrum Antibiotic).
6. M/s. Ani Cure Veterinary Coli-2400 Oral 1000ml 03 years Approved
M/s. InterchemieWerken ”De ColistinSulphate...2,400,000 IU
Adelaar” B.V. Metaalweg, (Antibiotic).
CG Venray, Holland.
7. M/s. Ani Cure Veterinary Introflor-100 Oral 100ml 03 years Approved
M/s. InterchemieWerken ”De Florfenicol…………...100mg
CG Venray, Holland.
8. M/s. Ani Cure Veterinary Macrotyl 250 Oral 500ml 03 years Approved
Services, Rawalpindi. / Each ml contains:- 1000ml
M/s. Tilmicosin
InterchemieWerken”DeAdela (TilmicosinPhosphate)...250mg
ar” B.V.Metaalweg, CG (Antibiotic).
Venray, Holland.
9. M/s. Ani Cure Veterinary Coliflox Oral 100ml 03 years Approved

ColistinSulphate…1,200,000 IU
Enrofloxacin………..….100mg
M/s. InterchemieWerken ”De (Antibiotic).
Adelaar” B.V. Metaalweg,
CG Venray, Holland.
10. M/s. Ani Cure Veterinary Norflox-200 Oral 100ml 03 years Approved
M/s. InterchemieWerken ”De Norfloxacin……………200mg
CG Venray, Holland.
11. M/s. PantexPharmaceutica, Pantril 100 Oral Solution 100ml 02 years Approved
M/s. Pantex Holland B.V. Enrofloxacin………….10gm 1 Liter
Duizel, Holland. Excipients……………...q.s
(Antibiotic)
12. M/s. PantexPharmaceutica, Pantadox Water Soluble 100gm 03 years Approved
M/s. Pantex Holland B.V. Each gm contains:- 500gm
Duizel, Holland. Doxycycline 1000gm
Hydrochloride……..…..150mg
TylosinTartrate……….200mg
(Antibiotic)
(C) M/s. Orient Traders International, Karachi’s request for transfer of registration of their various
approved imported veterinary drugs from the name of previous importer M/s. Orient Animal
Health (Pvt) Ltd, Karachi to their name was approved in its 236th& 237th meetings through sub-
committee constituted by the Board. The registration letters, however, were not issued. The
firm subsequently applied for change of name of importer and manufacturers/packager etc. The
detail of the drugs along with status of documentation as provided by the applicant is given as
under:-
S. Name of Drug (s)/ Approved Manufacturer/ Product Remarks

No. Composition manufacturer License Holder as per CoPP
as per
Minutes
(i) (ii) (iii) (iv) (v)
1. Iverveto-1 Solution for M/s. Manufacturer: i) As per CoPP of Belgium
Injection V.M.D.N.V. M/s. LaboratoiresBiove, 3 Rue de the products is not licensed
Each ml contains:- HogeMauw Lorraine, 62510 Arques, France. for marketing in Belgium as
Ivermectin…….…..10mg 900, B-2370 (bulk manufacturer, packaging, the marketing authorization
Glycerol formal……0.4ml Arendonk lot analysis) was not requested (as
Water for injection Belgium. Labelling& Batch Release: perCoPP this product is not
q.s.ad………………..1ml M/s. V.M.D. n.v/s.a.Hoge, Mauw use in animal producing
900, 2370, Arendonk, Belgium. milk for human).
Product License Holder: ii) The product is marketed
M/s. V.M.D. n.vHoge, Mauw in Hungary.
900, 2370, Arendonk, Belgium. iii) The shelf life 36 months
as per Form-5A.
2. Enroveto-20 Concentrate -do- Manufacturer: i) As per CoPP of Belgium
for Oral Solution M/s. LaboratoiresBiove, 3 Rue de the products is not licensed
Each ml contains:- Lorraine, BP 45 62510 Arques, for marketing in Belgium as
Enrofloxacin……200mg France. the marketing authorization
Glacial Acetic (bulk manufacturer, packaging, was not requested
Acid…………..….100mg lot analysis) ii) The product is marketed
Purified Water Labelling, & Batch Release: in Hungary.
q.s.ad……………….1ml M/s. V.M.D. n.v/s.a.Hoge, Mauw iii) The shelf life 36 months
900, 2370, Arendonk, Belgium. as per Form-5A.
M/s. V.M.D. n.vHoge, Mauw
900, 2370, Arendonk, Belgium
3. Florattacq-10 Oral -do- Manufacturer: i) As per CoPP of Belgium
Solution M/s. LaboratoiresBiove, 3 Rue de the products is not licensed
Each ml contains:- Lorraine, BP 45 62510 Arques, for marketing in Belgium as
Florfenicol………100mg France. the marketing authorization
(bulk manufacturer, packaging, was not requested (as per
labeling , lot analysis) CoPP this product is not
Labelling& Batch Release: approved for use in food
M/s. V.M.D. n.vHoge, Mauw producing animal).
900, 2370, Arendonk, Belgium. ii) The product is marketed
Product License Holder: in Hungary.
M/s. V.M.D. n.v. HogeMauw iii) The shelf life 36 months
900, 2370, Arendonk, Belgium. as per Form-5A.
(D)M/s. Orient Traders International, Karachi requested for transfer of registration of following
registered imported veterinary drugs from the name of importer M/s. Orient Animal Health (Pvt) Ltd,
Karachi to their name and also change of manufacturer and marketing authorization holder was
considered by the Registration Board in its various meetings and deferred for not being in free sale in
country of origin.
S. Regn. Name of Drug Packing Manufac Manufacturer Remarks/ Status as per
No. No. (s)/ composition as per turer as as per CoPP Shortcomings information/
Regn. per documents
Letter/ Registrat provided by the
Shelf ion firm.
life Letter
(i) (ii) (iii) (iv) (v) (vi) (vii) (viii)
1. 049548 Diminaveto 100 M/s. Applicant for Not free sale in Legalized GMP of
Soluble Sachets V.M.D. Certificate: Belgium (For M/s.
Granules per N.V. M/s. V.M.D. export only). LaboratoriaSmeets
Each gm carton Belgium. n.vHogeMauw NV.
contains:- 900 B-2370 GMP not Legalized GMP
Diminazene 10 Arendonk, provided. agreement of the
Diaceturate…… Sachets Belgium. manufacturer under
……445mg per Bulk, Availability contract VMD NV &
Antipyrine…… carton manufacturer, status in M/s.
…...555mg Sachet packing, lot reference LaboratoriaSmeets
analysis, batch country needs NV.
05 years release: clarification. Letter stating that
M/s. disease not prevalent
LaboratoriaSm in mfg. country or
eets BVBA, countries due to cold
Fotografielaan climate & are free
42, 2610, from
Wilrijk, trypanasomiasis by
Belgium. Office International
des Epizooties
(“OIE”). (Free sale
status in reference
countries not
provided).
2. 023475 Pen- 50ml M/s. Bulk Not Free Sale Generic and Meet to
Dihydrostrep 100ml V.M.D. Manufacturer, in Belgium. product, CoPP for
20/20 Injection N.V. Primary & export only from
Each ml 02 years Belgium. Secondary No GMP for Belgian authorities
contains:- Packaging, UK already submitted.
Procaine Batch (No evidence of free
Penicillin G Analysis: Availability sale in reference
200mg M/s. Norbrook status in countries provided).
Dihydrostreptom Laboratories referene
ycin base (as Ltd., Newry country needs
sulphate)……… (Northern clarification.
…….200mg Ireland). Co.
Down, United
Kingdom.
Secondary
packaging,
batch release:
M/s. V.M.D.
nv, HogeMauw
900, 2370
Arendonk,
Belgium.
3. 020807 Albeveto-10 100ml M/s. -do- Not free sale in Generic and Meet to
Oral Suspension 500ml V.M.D. Belgium (For product, CoPP for
Each ml 1000ml N.V. export only). export only from
contains:- Belgium. Belgian authorities
Albendazole… 03 years Availability already submitted.
……….100mg status in (No evidence of free
referene sale in reference
country needs countries
clarification provided).
4. 020849 Gentaveto-15 30ml M/s. M/s. V.M.D. No certificate Generic and Meet to
Injectable 100ml V.M.D. n.vHogeMauw (CoPP/GMP) product, CoPP for
Solution N.V. 900 B-2370 provided. export only from
Each ml Belgium. Arendonk, Belgian authorities
contains:- 03 years Belgium. already submitted.
Gentamycin (No evidence of free
Sulphate sale in reference
equivalent to countries
150mg provided).
Gentamycin
base
5. 023471 VMD-Tylosin 1Kg M/s. M/s. V.M.D. No certificate Generic and Meet to
Phosphate 25% 2.5Kg V.M.D. n.vHogeMauw (CoPP/GMP) product, Antibiotic
Premix 10Kg N.V. 900 B-2370 provided. Growth Promoterss
Each gm 25Kg Belgium. Arendonk, (AGPs) are banned in
contains:- Belgium. EU so CoPP for
Tylosin .250mg 03 years export only from
Belgian authorities
already submitted.
(No evidence of free
sale in reference
countries
provided).
The group deliberated in detail the issue of veterinary drug application, which are not in free sale
in the country of origin / manufacture. The individual cases were also reviewed and it was noted that
most of the formulations containing antibiotics are me-too and likely to be in demand locally. The
working group decided to have a case to case review of the products through a committee of relevant
experts. The following composition is proposed for the Committee to be constituted for this purpose:-
i. Two relevant veterinary experts (veterinary pharmacologist & veterinary medicine).

ii. Representative of PE&R Division.
iii. Representative of QA/LT Division.
The Committee will evaluate in detail drug applications referred to it and give
recommendations specifically with reference to the followings parameters:
i. Safety & efficacy of the products.

ii. Rationality of formulations and pharmaceutical compatibility.
iii. Strength / potency to be allowed in view of current veterinary practices.
iv. Recommended pack size.
Item-III Any other item with permission of Chairman.
With reference to agenda item discussed in 1st meeting of expert working group regarding
recommendations of the Commission relating to poultry sector, constituted by Supreme Court of
Pakistan, , as forwarded by the Live Stock & Dairy Development Department, Govt. of Punjab, Dr.
Mazhar ul Haq briefed the group regarding the antibiotics growth promoters (AGP). He informed that
the positive and negative list provided in the notification of Live Stock & Dairy Development
Department, Govt. of Punjab needs to be reviewed in consultations with stake holders as it require
clarification on many points.
It was, however, noted that import, manufacture and sale of antibiotics for veterinary use are
already regulated through grant of registration under Drugs Act, 1976. These antibiotics are primarily
registered for therapeutics or preventive use. However, the matter of their use as growth promoter as
feed stuff / additive relates to veterinary clinical practices and does not fall directly under the preview of
DRAP. Moreover, the Authority regulating the feed manufacturing will be more appropriate forum for
enforcement of the relevant regulations. The group, therefore, recommended that the Live Stock & Dairy
Development Department, Govt. of Punjab may be informed accordingly.
Decision:- Registration Board deferred the case for preparation of summery of

activities/actions/recommendations performed in 1st and 2nd meeting of Expert
Working Group on Veterinary Drugs for further deliberation.
Case.No.04:- Request of M/s. Medinet Pharmaceuticals, Rawalpindi for Change of Name
of manufacturer for registered products Varedet Injection (Reg. No.
031391), Varedet Injection (Reg. No. 031392), Duvig Injection (Reg. No.
031393) & Anfotericina Fada Injection (Reg.No. 033128).
M/s. Medinet Pharmaceuticals, Rawalpindi requested for change of name of manufacturer for
registered products the details are as under:-
S.# Regn. Existing Name/ Existing Proposed Name of Initial Remarks/
No. Composition Name of manufacturer & registration Diary No.
manufacture Market with renewal R&I
r authorization
holder (as per
CoPP)
I II III IV V VI VII
1. 031391 Varedet Injection M/s. FADA Manufacturer & 27-7-2004 Dy. No. 7355
Each vial contains:- Pharma S.A., Product License Last renewal R&I dated
Vancomycin Argentina. Holder:- submitted on 27-02-2018.
HCI...............500mg M/s. Laboratorio 17-7-2014
Inernacional
Argentino S.A.,
1641, Tabare St.
C.A.B.A.
Argentine
Republic.
2. 031392 Varedet Injection -do- -do- 27-7-2004 -do-
Each vial contains:- Last renewal
Vancomycin submitted on
HCI...............1000mg 17-7-2014
3. 031393 Duvig Injection -do- -do- 27-7-2004 -do-
Each vial contains:- Last renewal
Dobutamine submitted on
HCI………….250mg 17-7-2014
4. 033128 Anfotericina Fada -do- M/s. Laboratorio 03-12-2004 -do-
Injection Internacional Last renewal
Each vial contains:- Argentino S.A. Av. submitted on
Amphotericin 12 de Octubre 21-11-2014
B………….50mg 4444, Quilmes,
Buenos Aires,
Republica
Argentina.
The firm has deposited fee of Rs.5,000 x 4 = 20,000/- and submitted the following supporting
documents:-
i) Copies of registration letters.
ii) Copies of renewal status.
iii) Original & legalized CoPP issued by Argentian Authority.
iv) Original & Legalized GMP issued by Argentian Authority.
v) Copy of Drug Sale License.
vi) Copy of change of corporate name amendment of the articles in corporation.
It is pertinent to mentioned that the firm has requested for change of name of
manufacturer for all the products from M/s. FADA Pharma S.A., Argentina to M/s. Laboratorio
Inernacional Argentino S.A., 1641, Tabare St. C.A.B.A. Argentine Republic. However, as per
CoPP of product at Sr. No.4, the name and address of manufacturer is mentioned as M/s.
Laboratorio Internacional Argentino S.A. Av. 12 de Octubre 4444, Quilmes, Buenos Aires,
Republica Argentina. which is different from the one requested by the firm. Similarly the
address of the manufacturer abroad was not mentioned on initial registration letter.
The case was deferred in 2nd PRVC meeting for getting clarifications from the firm on
following points:
(i) As per firm’s request for product, Anfotericina Fada Injection (033128),
the demanded manufacturing site with new name i.e. M/s. Laboratorio
Internacional Argentino S.A. is located at 1641, Tabare St. C.A.B.A.
Argentine Republic, whereas, as per CoPP the manufacturer is located at
Av. 12 de Octubre 4444, Quilmes, Buenos Aires, Republica Argentina.
(ii) As per CoPP the manufacturer and product license holder for products at
Sr. No.1-3 is M/s. Laboratorio Inernacional Argentino S.A., 1641,
Tabare St. C.A.B.A. Argentine Republic while as per GMP certificate is
the manufacturing facility and is located at different address.
(iii) Submission of approval of change of name of manufacturer with no
change in address from country of origin for the aforesaid products.
The firm in response has informed that there are five plants of M/s. Laboratorio Internacional
Argentino S.A. in Argentina including following mentioned in the GMP and CoPP. The entrance of
the first pant (a) has different doors which resulted in slight difference in address in GMP and CoPP:-
(a) The first plant is 1641/45/47 Tabare St. and 3668 Crespo St. (zip code
1437) of the Autonomous City of Buenos Aires.
(b) The third plant is 4444 12 de Octubre Av., Quilmes (Zib code 1879),
province of Buenos Aires.
The case was again deferred 6th PRVC meeting for clarification of response of the firm and
subsequently in 9th PRVC meeting following clarification of the firm considered and it was decided to
place the case for consideration of Registration Board.
S.No Query Observed in 2nd PRVC meeting Firms Reply
1. As per firm’s request for product, Name and address of manufacturer as per
Anfotericina Fada Injection (033128), the CoPP:
demanded manufacturing site with new M/s. Laboratorio Internacional Argentino
name i.e. M/s. Laboratorio Internacional S.A., Av. 12 de Octubre 4444, Quilmes,
Argentino S.A. is located at 1641, Tabare Buenos Aires, Republica Argentina.
St. C.A.B.A. Argentine Republic, whereas, as
per CoPP the manufacturer is located at Av.
12 de Octubre 4444, Quilmes, Buenos
Aires, Republica Argentina.
2. As per CoPP the manufacturer and product Name and address of manufacturer as per
license holder for products at Sr. No.1-3 is CoPP:
M/s. Laboratorio Inernacional Argentino M/s. Laboratorio Internacional Argentino
S.A., 1641, Tabare St. C.A.B.A. Argentine S.A., Tabare 1641, C.A.B.A. Argentine
Republic while as per GMP certificate the Republic.
manufacturing facility is located at different The plant has different entrance doors with
address different numbers. In the GMP is Tabare
1641/45/47. Tabare 1641 is the main entrance
door.
3. Submission of approval of change of name Firm has provided a copy of English
of manufacturer with no change in address Translation of document issued by Ministry of
from country of origin for the aforesaid Health Policies Regulations and institutes
products. Secretariat, ANMAT (Argentine National
Drug Food and Medical Devices
Administration) wherein it is mentioned that
the M/s. Fada Pharma S.A has been acquired
by M/s. Laboratorio Internacional Argentino
S.A.
Decision:- Registration Board deferred the case for confirmation of address of manufacturer
from previous import clearance documents in order to ascertain that the
manufacturing site(s) is/are the same.
Case No.05:- Request for change of importer of registered imported veterinary drugs by M/s.
Hipra Pakistan (Private) Limited, Lahore.
M/s. Hipra Pakistan (Private) Limited, Lahore request for transfer of registration of their various
registered imported veterinary drugs from the name of previous importer M/s. Marush (Pvt) Limited,
K-123, Model Town, Lahore to their name. The details are submitted as under:-
Sr. Regn. Name of Drug (s) Approved Finished Initial Date of
No. No. Composition & Pack manufacturer as per Products Registration
Size Registration Letter & Specification
Shelf Life Claimed
(i) (ii) (iii) (iv) (v) (vi)
th
1. 080158 Selectan Injection M/s. Laboratories In House 08 March,
300mg/ml Hipra S.A, Avda, Specification 2016.
Each ml contains:- La Selva, 135 Amer
Florfenical…300mg (Girona) 17170,
Spain.
100ml polypropylene
bottle 24 months
2. 080159 Eficur Injectable -do- Manufacturer -do-
Suspension 50mg/ml Specification
Each ml contains:- 24 months
Ceftiofur as
Hydrochloride..50mg
100ml type II glass vial
3. 080160 Gentamox Injection -do- In House -do-
Each ml contains:- Specification
Amoxicillin 24 months
trihydrate……150mg
Gentamicin as
Sulphate………40mg
(equivalent to 40,000
I.U) as per CoPP &
Form 5A)
100ml Type II glass
vial
The firm has deposited required fee of Rs.100,000 x 3 = Rs. 300,000/- and submitted the
following documents:-
i) No Objection Certificate from M/s. Marush (Pvt) Ltd, K-123, Model Town, Lahore.
ii) Legalized Certificate of Pharmaceutical Products for above products.
iii) Certificate of GMP compliance of a manufacturer.
iv) Termination of Distribution Agreement.
v) Copies of Registration letters. Renewal not due.
vi) Letter of Appointment.
vii) Undertaking.
viii) Copy of Drug Sale License having address M/s. Hipra Pakistan (Pvt) Ltd, Office 3 & 4,
5th Floor, 105-B-II, Ali Tower, M.M.Alam Road, Gulberg, District Lahore.
ix) Form-5A mentions the address of Head Office i.e. M/s Hipra Pakistan (Pvt) Ltd, 191-A
Block, Shami Road, Cavalry Ground, Lahore Cantt, Lahore, Pakistan.
As per documents provided by the applicant the existing registration holder M/s. Marush (Pvt)
Ltd., Lahore has given a written declaration that they will transfer any right or title regarding
registration, import or any right regarding the product in question to the principal M/s. Hipra Pakistan
(Pvt.) Ltd, Lahore.
It has been informed by the applicant that M/s. Marush (Pvt) Ltd., Lahore filed a Civil Suit and
Appeal seeking restraining the transfer of registration. However, the Courts in both the Civil Suit and
the Appeal have refused to grant them any interim relief/ stay order. The applicant has therefore
requested to proceed further on their above mentioned request.
Decision: Deferred for confirmation of NOC from M/s Marush, (Pvt) Ltd., Lahore.
D. Registration-II Section
Case.No.6 Change Of Registration Status To New Title Of The Firm.

Registration Board in its 277th meeting held on 27-29th December, 2017, considered the
application and deferred the change in registration status of following products from previous name of firm i.e
M/s. Chas .A. Mendoza (DML No. 000140) to new name of firm i.e M/s. Le Mendoza Pharmaceuticals (Pvt.)
Ltd., Plot No. 7, Sector 23, Korangi Industrial Area, Karachi for confirmation of renewal status:-
S.No Reg.No Name of Drug(s) Renewal Remarks
validity till
1. Camoplex Lysine Syrup The RRR -
Each 5ml contains: section has
Vitamin B1... 4.16mg confirmed the
Vitamin B2... 1.66mg renewal of the
Vitamin B6....1mg product vide
003897 Vitamin B12... 8.33mcg their file
Niacinamide.. .18mg No.F.1-
Calcium d-pantothenate.. 2.5mg 58/2017-RRR
Vitamin C..75mg
Inositol.. 5mg
Lysine Monohydrochloride.. 33.33mg
2. Camovit M Capsules -do- -
Each Capsule Contains:
Vitamin A.. 25000 I.U.
Vitamin D2.. 1000 I.U.
Vitamin B1...10mg
Vitamin B2.. 10mg
Vitamin B6... 2mg
Vitamin B12.. 5mcg
Nicotinamide.....100mg
Ca-Pantothenate ..10mg
Vitamin E .... 1 I.U.
003893 Vitamin C … 150mg
Iron …...15mg
Calcium.....60mg
Phosphorus.....45mg
Iodine …. 0.15mg
Manganese .... 1mg
Potassium ….. 5mg
Copper ….. 1mg
Magnesium .... 6mg
Zinc ... 1.5mg
Cobalt ….. 0.1mg
Molybdenum…..0.2mg
3. Thiavit Capsules -do- -
Each Capsule contains:
003894 Thiamine HCl (B1).... 100mg
Pyridoxine HCl (B6)... 200mg
Cyanocobalamin (B12).. 200mcg
4. -do- Standard formulation
Robaxicam 20mg Tablet
approved by RRAs is
delayed release tablet
Rabeprazole (as Sodium).. 20mg
that contains
Rabeprazole
Sodium…20mg
5. -do- Standard formulation

Kilcam 250mg Tablet
approved by RRAs is
film coated and is
Clarithromycin U.S.P.... 250mg
available in USP.
6. Kilcam 500mg Tablet -do- -do-
Clarithromycin U.S.P....500mg
Now RRR section has confirmed that renewal applications of above mentioned products (extract retained from
No.F.1-58/2017-RRR) have been received within time. The firm has already submitted Form-5 and fee of Rs.
20,000/- for this purpose along with requisite documents which have been mentioned in 263rd and 277th meeting
of Registration Board.
Decision: Registration Board decided as under:
i. Approved change of registration status of products mentioned at S.No. 1-6 in
the new title of the firm i.e. M/s. Le Mendoza Pharmaceuticals (Pvt.) Ltd.,
Plot No. 7, Sector 23, Korangi Industrial Area, Karachi.
ii. The Board further advised to correct the finished product specifications and
formulations in accordance with the standard formulations approved by
Reference Regulatory Authorities, wherever required.
Case No.7. Change of Registration Status Of Drug(S) Of M/S. Laderly Bio-Tech Pharma, Karachi.
M/s. Laderly Bio-Tech Pharma, 803-Progressive Square, 11-A, P.E.C.H.S, Block-6, Shahrah-e-Faisal,
Karachi has requested for change of registration status of following products from import to local manufacture,
on contract from M/s. Global Pharmaceuticals (Pvt.) Ltd; Plot # 204-205, Industrial Triangle Kahuta Road,
Islamabad:-
S.No. Name of Drug(s0 Reg.No. Initial date of Reg.
1. Meropeon Injection 0.5gm 078144 27-01-2015
Each vial contains:- Registration is valid
Meropenem USP…………… 0.5gm
(USP Specification)
2. Meropeon Injection 1gm 078145 27-01-2015
Each vial contains:- Registration is valid
Meropenem USP …………… 1gm
(USP Specification)
The management of the firm has provided following documents:-

i. Application on Form-5 along with fee of Rs. 50,000/- for each product.
ii. NOC from M/s. Global Pharmaceuticals, Islamabad.
iii. Copy of NOC from existing manufacturer abroad.
iv. Contract agreement.
v. Copy of initial letter of registration as stated above in table.
vi. Copy of section approval by CLB.
vii. Copy of inspection report dated 12-07-2017 of M/s. Global, Islamabad.
Decision: Registration Board approved the change in registration status of following products from
import to local manufacture, on contract manufacturing from M/s. Global
Pharmaceuticals (Pvt.) Ltd; Plot # 204-205, Industrial Triangle Kahuta Road, Islamabad.
Applicant will provide original NOC from the manufacturer abroad and Chairman will
authorize issuance of letter.
Case No.8. Request for Extension Of Permission Of Bulk Import & Local Repacking of Drug(S) of
M/S. Atco Laboratories, Karachi (Pages 208-219/cor.).
M/s. Atco Laboratories Ltd; Karachi has requested for extension of permission of bulk import of local
repacking of their following already registered products:-
S.No. Name of Drug(s) with existing Reg.No. Registration history Formulation as per
formulation CoPP
1. Movelat Gel 017482 The firm was granted Mobilat Gel
Each 100gm contains:- previous extension of Each 100gm contains:-
Mucopolysacchride polysulphate permission for bulk Mucopolysacchride
…0.2gm import & local Polysulfuric acid ester
Suprarenal Extract …… 1gm repacking on 13-12- …0.2gm
Salicylic acid ………. 2gm 2012 which was valid Adrenal Gland Extract
till 5 years. ………. 1gm
Salicylic acid ……2gm
They have further stated that have equipped their facility to manufacture the above product, however,
the manufacturer did not allow to manufacture this product 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/- for this purpose.
ii. Copies of initial letters of registration and subsequent permission letters.
The Committee deferred the case in its 3rd meeting for provision of complete documents as per approved
SOPs and placement before Registration Board. The firm has provided CoPP for above product. The RRR
section has confirmed that the renewal application of year 2015 of above product is received within due time.
The Registration Board was further informed that the firm has already submitted a separate application
for change in the name of manufacturer of the instant formulation.
Decision: Registration Board advised to present both the applications i.e extension in permission of
bulk import and local repacking and change in name of manufacturer abroad in its next
meeting.
Case No.9 Request For Change of Registration Status of Drug(s) of M/s. Getz Pharma, Karachi.
M/s. Scilife Pharma (Pvt.) Ltd; Plot # FD-57/58-A2, Korangi Creek Industrial Park (KCIP)
Karachi-75190 has requested for change of registration status of following products from M/s. Getz Pharma,
Karachi to their name. The details are given as under:-
S.No. Name of Drug(s) Reg.No. Registration History Remarks
1. Scipride 25mg Tablet 057902 Init. Date of reg. 29- Formulation is non
Each tablet contains:- 07-2009 Pharmacopeial
Levosulpride …………….. 25mg Renewal applied on
(Manfuacturer’s Specification) 09-05-2014
2. Scipride 50mg Tablet 057903 Init. Date of reg. 29- -do-
Each tablet contains:- 07-2009
Levosulpride …………….. 50mg Renewal applied on
(Manufacturer’s Specification) 09-05-2014
3. Scipride 100mg Tablet 057904 Init. Date of reg. 29- -do-
Each tablet contains:- 07-2009
Levosulpride …………….. Renewal applied on
100mg 09-05-2014
(Manufacturer’s Specification)
4. Panslay SR 100mg Tablet 020301 Init. Date of reg. 16- Formulation is
Each tablet contains:- 10-1997 available in USP.
Diclofenac Sodium …… 100mg Renewal granted for 5 Label claim needs
years dated 15-10- to be standardized
2007 for Sustained
Renewal applied on Release Tablet.
02-07-2012
Last renewal applied
on 27-07-2017
Renewal section has been requested for confirmation of renewal status.
The management of the firm has provided following documents/information.

i. Fee of 20,000/- for each product.
ii. Application on Form-5.
iii. NOC from M/s. Getz Pharma, Karachi dated 16-01-2018 (for Sr.No. 1-3) and 08-11-
2017 (for Sr.No.4).
iv. NOC for CRF.
v. Approval of Tablet (general) Section issued by Licensing Division dated 01-06-2016.
vi. Copy of last inspection report dated 05-12-2017.
vii. Undertaking that the firm has does not have registration of above mentioned products
and undertaking for submission of validation/stability studies.
Registration Board deferred the case in 282nd meeting for confirmation of renewal status. Now the RRR
section has commented that the renewal applications of the above product received within time and the firm has
requested to approve their request.
a. Cancellation of registration of above mentioned products from name of M/s
Getz Pharma, Karachi.
b. Approved registration of products at S.No.1-3 with “Innovator’s
Specifications” and S.No.4 with “USP Specifications” in name of M/s Scilife
Pharma (Pvt.) Ltd; Plot # FD-57/58-A2, Korangi Creek Industrial Park
(KCIP) Karachi-75190. The Board further advised to standardize the label
claim of Panslay SR 100mg Tablet to “Each sustained release tablet contains:
Diclofenac Sodium …… 100mg”
c. Reference will be sent to Cost and Pricing Division for confirmation of
maximum retail price (MRP).
Case No.10. Adoption of Pharmacopoeial Specifications For Registered Products of M/s. Atco, Labs,
Karachi.
M/s Atco Laboratories Limited, B-18, S.I.T.E, Karachi-75700 have applied for adoption of
Pharmacopoeial specification for their following registered products:
S.No Reg.No Name of Drug(s) & Existing Demanded
Composition Specification Specifications
I II III IV V
1 029871 Napadoc Tablet Not mentioned BP
Codeine Phosphate.. 15mg
Paracetamol ………. 500mg
Caffeine …… 30mg
2. 003811- Zincviet-OD Syrup Not mentioned USP
EX Each 5ml contains:-
Zinc Sulphate Monohydrate
USP eq. to Elemental Zinc…..
20mg
The case was deferred in 5th meeting of PRVC for further deliberation and now the management of the firm
has provided following documents for this purpose:-
i. Original challan of Rs. 5000/-.
ii. Copies of initial letter of registration.
iii. Pharmacopieal reference.
iv. RRR section has confirmed that the renewal application of the above products received within
time, however, renewal application will be evaluated as per SOPs approved by the
Registration Board.
Decision: Registration Board approved the change in Finished Product Specifications as per detail
mentioned vide “Column V” of above table.
Case No.11. Correction in Registration letter of M/s. Atco, Labs, Karachi.

M/s Atco Laboratories Limited, B-18, S.I.T.E, Karachi-75700 have applied for correction of
strength of their following registered products:
S.No Reg.No Name of Drug(s) with Name of Drug(s) with Remarks
existing Composition existing Composition
I II III IV V
1 088221 Atcovate 0.05% Lotion Atcovate 0.05% Lotion The Registration Board
Each gm contains:- Each gm contains:- approved the existing
Fluticasone Propionate Fluticasone Propionate formulation as mentioned in
……. 0.05mg ……. 0.5mg column No. III. However,
(USP Specification) (0.05% w/v) correction is required in
(USP Specification) strength of Fluticasone
Propionate from
“0.05mg” to “0.5mg” and per
unit claim from
“Each gm contains:” to
“Each ml contains:”
The management of the firm has provided following documents for this purpose:-
i. Original challan of Rs. 5000/-.
ii. Copies of initial letter of registration.
iii. Registration is valid.
Decision: Registration Board deferred the case for confirmation of MRP fixed for “Fluticasone
Propionate 0.5mg/ml Lotion”.
Case No.12: Contract Manufacturing Permission to Novartis Pharma, Karachi.

The Registration Board in its 270th meeting while considering the request of M/s. Novartis
Pharma, Karachi for contract manufacturing permission for a number of their registered products, deferred the
following product for confirmation of approval status in reference regulatory authorities by the firm.
S.No Reg.No. Name of Drug(s) Registration Name of Remarks
validity Manufacturer
1. 007449 Mosegor –V Syrup i) Initial M/s Novartis Correct strength of
Each 10ml contains: registration dated Pharma (Pakistan) Thiamine
Thiamine 24.05.1984 ii) Ltd., 15-West hydrochloride:
hydrochloride…..175mg Last renewal dated Wharf Road, P.O. 1.75mg
Pizotifen………..0.50mg 14.05.2012 Box No. 100,
Riboflavin Karachi 74000
Phosphate………2.62mg
Pyridoxine
Hydrochloride……1.54mg
Nicotinamide …….10.50mg
Now M/s Novartis Pharma (Pakistan) Limited 15 West Wharf Road, Karachi has once again requested
for approval of contract manufacturing permission for above mentioned product stating that the instant
formulation has established role in management of migraine and there are several products already registered by
DRAP with similar formulation. The details are given below:-
S.No. Brand Name Reg.No. Name of firm Remarks
1. Pizofen-V 022528 M/s. Alina Combined -
Pakistan (Pvt.) Ltd; Lahore.
2. Pifin Plus 037138 M/s. Libra (Pvt.) Ltd; -
Peshawar.
3. Cestonil Plus 021843 M/s. Raazee Theraputics, Registration status could not be
Lahore verified from available record.
4. Medigor-B 005719 M/s. Medicon -do-
Pharmaceuticals, Peshawar
5. Zaygor-V 000358 M/s. Zaynoon, Peshawar Registration status is in-valid.
Decision: Registration Board decided to issue show cause notice to all the registration holders of instant
formulation, being ir-rational.
Case No.12. Change of Registration Status of product(s) of M/s. Park Davis B-2, SITE, Karachi
M/s. Pfizer Pakistan Limited, 12, Dockyard Road, West Wharf, Karachi-74000 has requested for
change of registration status of following product from M/s. Park Davis B-2, SITE, Karachi to their new name
i.e M/s. Pfizer Pakistan Limited, B-2, SITE, Karachi. The details are given below:-
S.No Reg. Name of Drug and Renewal status Remarks
No. Composition
1. 061333 Isteblix 75mg Tablet The RRR section has Registration Board in its
Each tablet contains:- confirmed that the renewal of 282nd meeting deferred the
Clopidogrel as Bisulfate … the year 2015 is received case for confirmation of
75mg within due date. renewal status.
(USP Specification) Standard formulation
approved by RRAs is Film
coated.
2. 067292 Ligazo Tablets 15 mg -do- -
Pioglitazone HCl eq. to
Pioglitazone …. 15mg
(USP Specification)
(USP Specification)
(USP Specification)
5. 067373 Xaprox 275 mg Tablets The RRR section has informed -
Each tablet contains:- that renewal application is
Naproxen Sodium …… received within 60 days after
275mg expiry of registration with
(USP Specification) requisite fee which is to be
regularized from Registration
Board. Final status will be
communicated after its
regularization from Board.
6. 067374 Xaprox 550 mg Tablets -do- -
Naproxen Sodium..550mg
(USP Specification)
7. 061570 Relevole Capsules The RRR section has informed Pellets source needs to be
Each Capsule Contains: that fee for imported pellets is confirmed.
Omeprazole enteric coated required and case is to be Formulation is available in
pellets eq. to regularized from Registration USP.
Omeprazole…..20mg Board after submission of
(Manufacturer’s requisite fee.
Specifications)
8. 061571 Relevole Capsules -do- Pellets source needs to be
Each Capsule Contains: confirmed.
Omeprazole enteric coated Formulation is available in
pellets eq. to USP.
Omeprazole…..40mg
(Manufacturer’s
Specifications)
9. 070508 Minidiab AF 2.5/250 mg The registration is valid till 26- Standard formulation
Tablets. 04-2021 approved by RRAs is film
Each Tablet contains: coated.
Glipizide….2.5mg
Metformin HCL…250 mg
(USP Specification)
10. 070509 Minidiab AF 2.5/500 mg -do- -do-
Tablets.
Each Tablet contains:
Glipizide….2.5mg
(USP Specification)
11. 070510 Minidiab AF 5/500 mg -do- -do-
Tablets.
Each Tablet contains:
Glipizide….5mg
(USP Specification)
CASES OF CONTRACT MANUFACTURING
12. 015099 Lincocin Inj.300mg/ml The registration is valid till 30- The product is registered
Each ml contains:- 06-2020. through contract
Lincomycin HCl … 300mg manufacturing by M/s. Sanofi
(USP Specification) Aventis Pakistan, Plot No. 23,
Sector 22, Korangi Industrial
Area, Karachi.
Standard formulation
approved by RRAs contains:
“Lincomycin as
HCl…300mg/ml”
13. 000605 Lincocin Inj.600mg/2ml -do- (-do-)
Each 2ml contains:- Standard formulation
Lincomycin HCl … 600mg approved by RRAs contains:
(USP Specification) “Lincomycin as
HCl…600mg/2ml”
14. 013841 Cefobid Injection.0.5gm -do- Standard formulation
Each ampoule contains:- contains:
Cefoperazone Sodium “Cefoperazone as
…………. 0.5gm Sodium….0.5gm
(USP Specification) ”
15. 008524 Cefobid injection 1gm. -do- Standard formulation
Each ampoule contains:- contains:
Cefoperazone Sodium “Cefoperazone as
…………. 1gm Sodium….1gm”
(USP Specification)
The firm has provided following documents:-

i. Application on Form-5.
ii. Copies of initial letter of registration and renewal status as stated above.
iii. Original challan of fee of Rs. 20,000/- for product as Sr. No. 1-15.
Decision: Registration Board decided as under:
i. Approved change of registration status of products mentioned at S.No. 1-4 & 9-11 in the
new title of the firm i.e. M/s. Pfizer Pakistan Limited, B-2, SITE, Karachi.
ii. Approved change of registration status of products mentioned at S.No. 12-15 in the new
title of the firm i.e. M/s. Pfizer Pakistan Limited, B-2, SITE, Karachi on contract
manufacturing from M/s Sanofi Aventis Pakistan, Plot No.23,Sector 22, Korangi
Industrial Area Karachi.
iii. Deferred the products at S.No.5-6 till the confirmation of renewal status.
iv. Deferred the products at S.No.7-8 till the confirmation of renewal status and submission
of source of Omeprazole pellets by the firm.
v. The Board further advised to correct the finished product specifications and
formulations in accordance with the standard formulations approved by Reference
Regulatory Authorities, wherever required.
Case No.13. Change of Manufacturer (Title Remain same)

Registration Board in its 268th meeting considered the request of M/s GlaxoSmithKline
Pakistan, Karachi 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:
S. Existing New Reg. No. Name of drug(s) & Initial registration with date
No. manufacturer manufacturer Composition 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 application
West Wharf, Korangi Site, received with in stipulated time
Karachi Karachi 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 application
Water for Injection received with in stipulated time
......….2ml period
(USP Specification)
.......….3ml period
(USP Specification)
.......5ml period
(USP Specification)
5. -do- -do- 10666 Amikin i)Initial registration
Injection100mg dated 31.03.1990
Contains: ii) Original renewal application
Amikacin received with in stipulated time
Sulphate..100mg period
6. -do- -do- 005488 Amikin Injection i)Initial registration

500mg/ml dated 25.04.1984
Each 2ml contains: ii) Original renewal application
Amikacin.500mg received with 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 Registration
Amikacin.250mg 01.10.2010
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 issuance of
 Deferred products at S.No.2 and 8 for clarification of composition.
Later on, in 281st meeting, the Board was informed that the registration letter of product at
Sr.No. 3-5 has been issued to the firm. While preparing the minutes of the meeting (M-268) the product
at Sr.No. 2 & 8 were mistakenly mentioned as deferred instead products at Sr. No. 1 & 7, which may
be corrected accordingly.
Decision of 281st Meeting:
Registration Board noted the information for correction in the minutes of 269th meeting of Registration
Board.
Now the case has been presented before the Board for following corrections in minutes of 281st meeting:
 Correction in meeting No. mentioned in the decision of M-281 i.e 268 instead of 269.
 Correction in serial numbers of deferred products i.e Sr. No. 1,6 & 7 instead of 1 and 7.
Decision: Registration Board noted the information.
Case No.14. Request for change of registration status of products from import in finished form to
bulk import and local repacking on contract basis, along with change of brand name.
M/s Allied Distributor Akhai Arcade, 1st Floor, 103-K Block-2, PE.C.H.S. Karachi have applied
for change of registration status of following products from import in finished form to bulk import and local
repacking at M/s Akhai Pharmaceuticals (Pvt) Ltd., Hub, Balochistan on contract basis:
S.# Regn Name and Composition Packi Maxim Renewal status
No. ng um
retail
price
1. 021190 Broadsaf 250mg Injection Per Rs. Initial date of registration –
Each vial contains: vial 120.00 15.10.1998
Ceftriaxone Sodium eq. to 250mg 1st renewal: 15.09.2003
Ceftriaxone base. change of brand name:
13.09.2004
2nd renewal: 14.10.2008
3rd renewal: 04.10.2013
2. 021191 Broadsaf 500mg Injection Per Rs. -do-
Each vial contains: vial 195.00
Ceftriaxone Sodium eq. to 500mg
Ceftriaxone base.
3. 021192 Broadsaf 1gm Injection Per Rs. -do-
Each vial contains: vial 385.00
Ceftriaxone Sodium eq. to 1gm
Ceftriaxone base.0
Registration Board deferred the case in 259th meeting for confirmation of manufacturer of products,
renewal status and quality control facility of M/s Akhai Pharmaceuticals (Pvt) Ltd., Hub for final release of the
product after packaging.
The firm has submitted form -5 along with requisite fee of Rs.50,000/- as contract manufacturing /
repacking at M/s Akhai Pharmaceuticals (Pvt) Ltd., Hub. The firm has also provided the above
information including CoPP of the manufacturer and copy of GMP inspection report regarding QC facility of
the firm i.e M/s. Akhai Pharmaceuticals, Karachi and again requested that to save the foreign exchange, they
applied for the permission of bulk import and local repacking from labeled vial manufactured by M/s. Kyung
Dong Pharma, Co., Ltd., 224-3 Jeyakdanji-ro, Yanggam-myeon, Hwaseong-si, Gyeonggi, Republic of Korea
and secondary repacking at M/s. Akhai Pharmaceuticals (Pvt.) Ltd; (APPL) Hub, Balochistan. The product will
be imported as labeled vials in the bulk packing and will be repacked to a single 1’s pack of each vial at packaging
line of M/s. APPL. They have provided original and legalized CoPP by manufacturer abroad and also requested
to change the brand name of above product from “Broadsaf” to “Ceftisone”. The RRR section has informed that
the renewal applications of the above products received within time.
Decision: Registration Board deferred the case for submission of protocols for final release of product
after packaging by M/s Akhai Pharmaceuticals (Pvt) Ltd., HUB, Balochistan.
Case No.15. Revision of Formulation of Registered Product(s) of M/s. Akhai Pharmaceuticals (Pvt.)
Karachi.
M/s. Akhai Pharmaceuticals (Pvt.) Ltd; A-248, A-256 to A-259, H.I.T.E, Lasbella, Balochistan
has requested for revision of formulation of their following registered product:-
S.No. Name of Drug(s) with existing Name of Drug(s) with demanded Reg.No.
formulation formulation
1. Zonacin 500mg Capsule Zonacin 500mg Tablet 070429
Each capsule contains:- Each film coated tablet contains:- dated 21-04-
Azithromycin ………… 500mg Azithromycin ………… 500mg 2011
(BP Specification) (USP Specification)
The firm has stated that after reviewing the effectiveness and dosage of capsule against the tablet
formulation which contains same molecule, they believe that their formulation should be changed to tablet. The
firm has stated that Azithromycin is not available in BP specification and it is available in USP specification.
They have requested to correct the specification from BP specification to USP specification. The firm initially
provided fee of Rs. 5000/- only along with Form -5 for above product.
The PRVC in its 4th PRVC deferred the case to provide fee of Rs. 20,000/- and Form-5 and evaluation
of the case in light of 250th meeting decision of Registration Board. The management of the firm has provided
relevant information along with balance fee of Rs. 15,000/-. The RRR section has informed that the renewal
application of the above product received within time.
Decision: Registration Board approved the revision of formulation of Zonacin 500mg Capsules to
Zonacin 500mg Tablets with USP Specifications.
E. QA & LT Division
Item no. 1 Delegation of powers
In order to facilitate timely disposal of routine cases relating to contravention of various provisions of
the Drugs Act, 1976, the board decided to extend the delegation of powers to the Chairman, Drug
Registration Board for three years, as previously given by Drug Registration Board under the Drugs
Act 1976, DRAP Act 2012 and the rules framed there under
Drug Registration Board considered the matter in its 283rd meeting held on 27th to 29th June 2018 and
decided to delegate the following powers to its chairman subject to conditions mentioned in the law.
Sr. Power of the Board Provision of Drugs Act, 1976

No.
I Show cause notice issuance (section 7(11)(d) of the Drugs
Act (Licensing, Registering and
Advertising) Rules, 1976))
II To continue the custody of the seized stocks by the (Section 18 (f))
FID till decision of case
III To extend the period of “not to dispose off” for Section 18 (i))
three months
IV To grant approval for sending the board’s portion Section 22 (5)
of drug samples to the Appellate Laboratory under
the Drugs Act 1976
V Grant of extension in the time of testing to Federal {Section 22 (2)}
government Analytst
VI Lodging of FIR As per law
VII Assistant Director QC is authorized to issue letters
of quality control cases on behalf of DRB after
getting approval by RB/ Chairman Drug
Registration Board.
F. Division of Biological Evaluation and Research.
Case No. 1 Exemption of URDU text on Imported Vaccine and Permission for local laser jet
printing applied by M/s GSK Karachi.
Reg. No. Name of Drug and Composition

087954 Boostrix
Suspension for injection in prefilled syringe Diphtheria, tetanus and
Pertussis (acellular, component) vaccine (adsorbed, reduced antigens
Date of content)
Registration
23-02-2018 Each one dose(0.5ml) contains: -
Diphtheria Toxoid* not less than………………………….………...2IU
Tetanus Toxoid* not less than……………………………………20IU
“Bordetella Pertussis” antigens:
Filamentous Haemagglutinin*……………………...8mcg
Pertactin*……………………………..2.5mcg
*adsorbed on aluminum hydroxide, hydrated

(Al(OH)3……………………0.3mg Al3+ and
Aluminium phosphate………0.2mg Al3+
Firm request that; due to import of limited stocks our above country manufacturing source cannot
provide us the stocks of Boostrix vaccine in country specific packs.
Also, since same source i.e., GSK Biologicals supplies Boostrix and other vaccines to many other
markets, separate run of manufacturing/packaging operation is not practically feasible for Pakistan
supplies as this may result in shortages in other markets due to production constraints at Belgium site.
In order to launch this vaccine as early as possible in Pakistan and to avoid any availability issues, we
therefore request you to please allow us ‘to import Boostrix without URDU text and to print local
registration number, MRP and brand name in URDU through laser jet printer locally at licensed
warehouse/premises’.
Decision: Registration Board acceded to the request of the firm for import of already
registered Boostrix Suspension for Injection in PFS (Reg. No. 087954) in Standard
Export Packs. The Board advised the firm to comply provision of Drugs (Labelling
& Packing Rule, 1986) including MRP and Registration Number along with Urdu
Text before sale of drug by locally printing at M/s GSK Pakistan Limited, F-268
S.I.T.E., Karachi before sale of drug.
Case No. 2 Local human Biological applied for registration by M/s Macter International
Limited, Karachi.
Following products of M/s Macter International Karachi were deferred in 275th meeting of
S. Name of Brand name & Composition Document Decision of
No. Manufacturer Details 275th meeting
of
Registration
Board
1. M/s Macter Epocan Copy of GMP Registration
International (Solution for injection) certificate No. Board referred
Karachi Each vial (ml) contains: 07/2018- the
Epoetin alfa………2000IU(0.0135mg) DRAP(K) applications to
dated 02-01- the working
Shelf Life: 3 years (Store at 20C-80C) 2018 group/
2. Epocan 4000IU/ml indicating committee
(Solution for injection) Biological constituted in
Each vial (ml) contains: Section. 273rd meeting
Epoietinalfa…4000IU(0.027mg) of
Registration
Shelf Life: 3 years (Store at 20C-80C) Board.
3. Epocan 10000IU/ml
(Solution for injection)
Each vial (ml) contains:
Epoietinalfa………10000IU(0.0675mg)
Shelf Life: 3 years (Store at 20C-80C)
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:
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 biological i. GMP certificate (Certificate No. CN
drug substance manufacturer abroad (who will provide 20140140 valid till 16-03-2019) of
concentrate / ready to fill bulk of biological drug to Pakistani biological drug substance
manufacturers for further processing) as an evidence that the manufacturer abroad (who will
manufacturer is an authorized manufacturer of biological drug in provide concentrate / ready to fill
the country of origin. bulk of biological drug to Pakistani
manufacturers for further
processing).
The firms shall provide legalized free sale certificate/CoPP either i. Valid legalized CoPP (Certificate
from country of origin or by any reference regulatory authority No.WHO-CPP-CERT-ZQ-151116
as adopted by Registration Board of finished product as evidence issuing date 16-11-2015) from
that the final product has been manufactured by same country of origin of finished product.
concentrate/ready to fill bulk after submission of data to the
concerned regulatory authority.
The firm shall provide the complete Bio-similarity studies of the Complete Bio-similarity studies of the
finished product of same source (bulk concentrate or ready to fill) finished product of same source (bulk
manufactured either from country of origin or by any reference concentrate or ready to fill)
manufactured from country of origin.
regulatory authority as adopted by Registration Board to
demonstrate the bio-similarity.
The firm shall provide the lot release certificate of the finished Lot release certificate of the finished
product manufactured by same bulk concentrate/ ready to fill product manufactured by same bulk
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 time The firm provided the 6 months
stability studies for drug substance. accelerated and real time stability studies
for drug substance.
The local manufacturer shall manufacture three trial batches of After locally manufacturing three trial
the finished biological product to finalize the formulation and batches of the finished biological product
then perform analytical studies(Physicochemical and biological) to finalize the formulation, firm submit
including protein content, appearance, pH, Osmolarity, the results of performed analytical
composition of key excipients including stabilizers (if studies (Physicochemical and biological)
formulation is same), visible/subvisible particles, identity testing including protein content, appearance,
to parent molecule, purity testing, in vitro biological activity, pH, Osmolarity, composition of key
sterility, Pyrogen content, safety, potency and toxicity with excipients including stabilizers (if
support of iso-electro focusing data, gel electrophoresis, formulation is same), visible/subvisible
Western-Blot and other analytical techniques). The firm shall particles, identity testing to parent
submit the results for processing of registration application. molecule, purity testing, in vitro
biological activity, sterility, Pyrogen
content, safety, potency and toxicity with
support of iso-electro focusing data, gel
electrophoresis, and other analytical
techniques).
The manufacturer shall perform all tests locally as detailed on Results of all locally performed tests as
Certificate of analysis. detailed on Certificate of analysis.
The firm shall also provide the list of finished products being list of finished products being
manufactured from same bulk concentrate or ready to fill form in manufactured from same bulk
any country of the world (if available). concentrate or ready to fill form is
provided.
The firm shall provide the agreement with the source (of bulk Provide the agreement with the source
concentrate/ready to fill) that if there shall be any critical change (of bulk concentrate/ready to fill) that if
in manufacturing process, biological systems used to there shall be any critical change in
manufacture, etc. the firm shall inform DRAP immediately along manufacturing process, biological
with relevant documents. systems used to manufacture, etc. the
firm shall inform DRAP immediately
along with relevant documents.
Regular monitoring through pharmacovigilance reporting system Post marketing surveillance system.
shall be observed through proper pharmacovigilance cell of the Recall system
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 event Provided the undertaking and agreement
or ADR reporting from the country of manufacture of with manufacturer of concentrate/ready
concentrate/ready to fill bulk and finished product as required to fill bulk.
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 i. Primary sequence.
Physicochemical ii. Amino acid composition.
characterization iii. N-terminal analysis.
iv. C-terminal.
v. Peptide mapping.
vi. Disulfide bond analysis by mass spectrometry.
vii. N-linked oligosaccharide analysis.
viii. Isoform by capillary zone electrophoresis and isoelectric focusing.
ix. Spectrum by Circular dichroism.
Biological Activity In-vivo activity by reticulocyte test.

In-vitro activity by cell proliferation test.
Immunochemical ELISA test.
properties Immunoblotting.
Impurities Impurity test perform by SDS-PAGE
Stability Studies Stability studies are provided.
Non-clinical Studies Acute toxicity study in mice.
Chronic toxicity study in rats.
Clinical Studies To, compare the treatment efficacy and safety between EPO
(recombinant human erythropoietin injection) produced by Shandong
Kexing Bioproducts Co., Ltd. And EPOGEN, originator rh EPO
provided by Amgen Inco, USA (n=204)
Decision: Keeping in view the GMP certificate of M/s Macter International Limited, Karachi
and data submitted in light of decision of 278th meeting; Registration Board approved the
products.
Case No. 3 Imported Human Biologicals applied by Helix Pharma (Pvt.) Ltd., Karachi
deferred in 281stmeeting of Registration Board.
Following products of Helix Pharma (Pvt.) Ltd., Karachi were deferred in 281st meeting of

Hakimsons House, A/56, S.I.T.E, Manghopir Road, Karachi-75700
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 Group Monoclonal antibody
Shelf life 2 years at 2-80C
Approval status in N/A
Reference countries
International availability INDIA

NEPAL
Bangladesh
Products already Mabthera of Roche Pakistan Ltd.
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 / Pack 34500/2 s’ vials
size
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.
Hakimsons House, A/56, S.I.T.E, Manghopir Road, Karachi-75700
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 Group Monoclonal antibody
Shelf life 2 years at 2-80C

Approval status in N/A
Reference countries
International availability INDIA
NEPAL
Bangladesh
Products already Mabthera of Roche Pakistan Ltd.
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 / Pack Rs. 85,500/1’s vials
size
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.
Decision of 281st
meeting of Registration Registration Board deferred the applications for submission of real time and
Board: accelerated stability data of three (03) commercial batches.
The firm has submitted the bio-similarity data as per following detail:
WHO Biosimilarity guidelines Data Submitted by the firm
Quality Comparison Comparative Structure elucidation
Physicochemical characterization Primary Structure
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
v. Aggregates (High Molecular Weight Impurities)
vi. Related impurities
Stability Studies Stability studies are provided.
Non-clinical Studies Pre-clinical Studies
iii. In-vitro Studies In-vitro Studies
iv. 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
iii) 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
iv) 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.
v) 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).
Remarks of Evaluator The firm has submitted the stability data.
Decision: Registration Board deferred the case for further evaluation of stability data by
DBER.
Case No. 4 Imported Human Biologicals applied by M/s Genix Pharma (Pvt) Ltd., Karachi
deferred in different meeting of Registration Board.
Following products of M/s Genix Pharma (Pvt) Ltd., Karachi were deferred in various
meeting of Registration Board as per following details:
Sr. Name of Importer Brand Name & Type of Form Document details
No. & Manufacturer Composition Dy No & Date of (CoPP)
application Reference agencies
Fee submitted availability
Pack size/ Demanded
Price
1. M/s Genix Pharma Derise 25mcg PFS Form 5-A Valid Legalized CoPP.
(Pvt) Ltd., 44 45-B No.
Korangi Creek Each Pre-filled Syringe Dy No. 207/2016(R&I) 4267E(K)/TS/2017
Road, Karachi (0.42ml) contains: 02-03-2016 Validity08-02-2019
Darbepoetin Alfa (In Rs.50,000/- 01-03-2016
M/s Hetero Drugs house)………25mcg Pack of 1’s/ Rs. 10 000/- Aranesp 25mcg of
Limited Unit-III, Sy Amgen USFDA
No.458(part), Anemia treatment in cancer
TSIIC-Formulation patients.
SEZ,
Polepally(Village), In-house Specs
Jadcheria (Mandal),
Mahaboobnagar(Di Shelf Life: 2 years
strict)—509 301,
Telangana, India.
2. Derise 40mcg PFS Form 5-A Valid Legalized CoPP.
Each Pre-filled Syringe No.
(0.40ml) contains: Dy No. 210/2016(R&I) 4578E(K)/TS/2017
Darbepoetin Alfa (In02-03-2016 Validity08-02-2019
house)………40mcg 21-ADC(BD) 08-08-
2016 Rs.50,000/- 01-
Anemia treatment in cancer 03-2016 Aranesp 40mcg of
patients. Pack of 1’s/ Rs. 15, Amgen Ltd. (UK)
000/-
In-house Specs
Shelf Life: 2 years
Case History
263rd meeting:
The case was initially considered in 263rd meeting of Registration Board and Board decided as follows:
“Deferred due to paucity of time”
264th Meeting:
The case was again placed before the board in 264th meeting and Board decided as follows:
“Deferred the product for evaluation of biosimilarity data”
Remarks:
As per Schedule I of DRAP Act, 2012: “Biosimilarity” means Similar Biotherapeutic Product which is similar in
terms of quality, safety and efficacy to an already licensed reference biotherapeutic product.
The biosimilarity studies were submitted by the firm in terms of safety and efficacy performed in comparative
clinical trials whereas, for quality lab tests Innovator product was used which requires in-depth evaluation by the
Divison and the expert if required.
Registration Board deferred above products for evaluation by Division of Biological Evaluation &
Research.

Guidelines
Quality Comparison i. Identity
Physicochemical Western blot and Isoelectric focusing (IEF)
Characterization ii. Primary Structure analysis
Amino acid sequencing
Mass spectrometry
N-terminal sequencing
C-terminal sequencing
Glycan site identification (N-linked)
Glycan site identification (O-linked)
Peptide mapping
iii. Higher Order structure
CD spectrometry
Intrinsic fluorescence
Extrinsic Fluorescence
Disulphide sequence analysis
Biological Activity In-vitro bioassay for Darbepoetin Alfa potency measure was evaluated using UT-7
cells.
In-vivo assay on normocythaemic mice.
Immunochemical Immunochemical properties by ELISA method.
properties
Impurities Product related purity and impurity
Purity and size related variant by Size exclusion chromatography (SEC) & SDS PAGE.
Charge related variants by Capillary zone electrophoresis (CZE).
Stability Studies Stability studies provided.
Non-clinical i. Acute toxicity study of Darbepoetin alfa in rats by intravenous route.
In-vivo Studies ii. Acute toxicity study of Darbepoetin alfa in rats by subcutaneous route.
iii. Acute toxicity study of Darbepoetin alfa in mice by intravenous route.
iv. Acute toxicity study of Darbepoetin alfa in mice by subcutaneous route.
v. Repeated dose toxicity study of Darbepoetin alfa in rats by subcutaneous route.
vi. Repeated dose toxicity study of Darbepoetin alfa in rats by intravenous route.
vii. Repeated dose toxicity study of Darbepoetin alfa in rabbits by subcutaneous route.
viii. Repeated dose toxicity study of Darbepoetin alfa in rabbits by intravenous route.
ix. Local tolerance.
Clinical Comparison A Randomized, Open Label, Multi-Center Study to Evaluate the Efficacy, Tolerability
and Safety of Darbepoetin Alfa as Compared to Erythropoietin in Anemia Associated
with Chronic Kidney Disease (CKD) (n=236).
A phase I, PK and PD study of darbepoetin alfa, Hetero and Aranesp (Darbepoetin alfa
injection, Amgen) in healthy adult human subjects. (n=52)
Evaluator Remarks:
Submitted Phase III clinical study conducted in comparison between Darbepoetin alfa and
Erythropoietin instead of Darbepoetin alfa with comparison to Darbepoetin alfa. Firm submit
clarification which is as under:
We, M/s Hetero Biopharma Limited, Sy. No.458 (part), TSIIC-Formulation SEZ Polepally (Village),
Jadcherla (Mandal), Mahaboobnagar (District) – 509 301, Telangana state, India, manufacturer of
Darbepoetin alfa (Biosimilar) drug product, would like to clarify that Phase III clinical study conducted
in comparison between Darbepoetin alfa and Erythropoietin instead of Darbepoetin alfa with
comparison to Darbepoetin alfa because the Darbepoetin alfa and Erythropoietin mechanism of action
and its therapeutic target profile are identical as these products belong to erythropoietin stimulating
agents (ESAs) category, also the safety and efficacy parameters of these are comparatively similar, no
significant differences were observed either in Aranesp® nor in Eprex®. Thus the selection of Eprex®
is considered based on the available literature and considerable evidence of clinical data.
In view of the above, the Eprex was chosen for comparative clinical trial after obtaining permission
from Indian Regulatory Authority (CDSCO), we have conducted clinical trials be using Eprex® as the
innovator product Aranesp® was not available in India. However we have performed Phase I clinical
studies (Healthy volunteers) and non-clinical studies with Aranesp®. The reports of the same have
been submitted to you earlier. Moreover, these studies are accepted to many regulatory authorities.
Furthermore, we have initiated to conduct Phase III studies with Aranesp® and the same will be provide
to MOH after completion of studies.
Decision: Registration Board deferred the case for submission of complete bio-similarity
data by the firm.
Meeting ended with vote of thanks to and from the Chair.
===================END OF DOCUMENT=================

Minutes of 283rd Meeting of Registration Board - 2

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Minutes of 283rd Meeting of Registration Board - 2

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HELD ON 27th TO 29th JUNE, 2018

Item No. Detail of Item Pages

III. Division of Pharmaceutical Evaluation &Registration 6-571

Drug Regulatory Authority of Pakistan

1. Dr. Rafeeq Alam Khan, Member

Mr. Zaheeruddin M.Babar (Dy.Director-Reg.I), Mr.Muhammad Amin (Dy.Director-Reg.II),

Decision: Registration Board approved / confirmed the minutes of 282nd meeting.

2.7 Clinical Summary Not Exempted Exempted

Case No. 02: Registration of Drugs Pending for Policy Decision:

Pharmaceutical Evaluation Cell

Total Cases: 973

11 Mst. Mehwish Javed Khan Evaluator PEC-XIII

M/s Bio-Labs (Pvt.) Ltd. has approved Lyophilization vial

M/s Bio-Labs (Pvt.) Ltd. has approved Lyophilization vial

M/s Bio-Labs (Pvt.) Ltd. has approved Lyophilization vial

Composition Each 2ml ampoule contains:

Composition Each Extended Release tablet contains:

Me – too Status Registration Number: 080283

Composition Each Extended Release tablet contains:

Me – too Status Registration Number: 070760

Decision: Approved with innovator’s specification.

Remarks of Evaluator Applied formulation is not present in USP & BP.

Decision: Approved with USP specification.

GMP status GMP status Last inspection conducted on 26-7-2017Overall

273. Name and address of manufacturer / M/s Hilton Pharma, Karachi

308. Name and Address of Manufacturer / M/s High-Q Pharmaceuticals,

322. Name and Address of Manufacturer / M/s Wilson’s Pharmaceuticals,

Decision: Approved with innovator’s specification.

Decision: Approved with innovator’s specification.

Decision: Approved with innovator’s specification.

Pharmacological Group Anti-Viral

Decision: Defered for the clarification of formulation as per reference product.

GMP status Last Inspection report 17-3-2017

Deferred for submission of differential fee for pellets from

M/s Delta Pharma Pvt Ltd, Risalpur

for the following sections

Tablet General Section: 11 Products/ 11 Molecules

Sr. No Section No. of products No. of molecules

Capsule Section (General)

Sr.No. Section Molecules Products

Sterile dry powder Injection (Cepahlosporin) section: 9 Products/ 3 Molecules

Case. No. M/s Max Pharmaceuticals. Rawalpindi. (New Section)

Me-too Status Sac-Lor 250mg/5ml Dry Suspension by M/s Semos Pharma

c. Deferred cases (Human)

Deferred Cases (Veterinary)

Veterinary Dry powder (General Antibiotic) (6molecules / 6products)

Case No. 04: Registration applications of categories to be considered on priority

b. Local manufacturing applications of priority categories defined by Registration Board

868. Name and Address of Manufacturer / M/s Allmed (Private) Limited,

Me-too status Nexavar 200mg Tablets By M/s Bayer Pakistan (Reg#052224)

Moreover, the Sponsor continues to monitor the stability of the

Decision: Approved as per policy of inspection for manufcaturer abroad.

Chloride Ion (Cl-) 120mmol/L

Decision: Approved as per policy of inspection for manufcaturer abroad.

a. New Cases (Human)

Sr.# Observations Firm’s reply

Sr.# Observations Firm’s reply

Me-too status Fluxin Injection 50mg/ml Of M/S. Mallard

Me-too status Imipro Injection of M/s Selmore Pharmaceuticals (Reg.#

Decision: Approved as per Policy for inspection of Manufacturer abroad

Decision: Approved as per Policy for inspection of Manufacturer abroad.

a. Onsite Verification of Stability Data