Minutes for 257th Meeting Registration Board held on 24-25th March, 2016.
Item No. Detail of Item Page No. Item No.I Confirmation of minutes of 256th meeting Registration Board 04 Item No.II Cases referred by Pharmaceutical Evaluation & Registration Division 04 – 285 Item No.III Cases referred by Biological Drugs Division 286 – 363 Item No.IV Cases referred by Quality Assurance & Laboratory Testing Division 364 – 376 Additional cases Item No.V Cases referred by Pharmaceutical Evaluation & Registration Division 377 – 506 Item No.VI Cases referred by Biological Drugs Division 507 - 513
Minutes for 257th Registration Board Meeting 1
257th meeting of Registration Board was held on 24-25th March, 2016 in the Committee Room, Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The meeting was chaired by Mr. Ghulam Rasool Dutani, Director Pharmaceutical Evaluation & Registration Division, DRAP. The meeting started with recitation of the Holy Verses. The meeting was attended by the following:- 1. Lt General (R) Karamat Ahmed Karamat. Member
2. Maj. Gen. Dr. Aslam Khan, Member Professor of Medicine, Military Hospoital
3. Mr.A.Q.Javed Iqbal Member
4. Sheikh Sarfraz Ahmad Member Additional Draftsman, M/o Law and Justice 5. Mr.Ghulam Mujtaba, Assistant Director Member Representative of IPO 6. Dr.Muhammad Arshad Member President, Pakistan Veterinary Medical Council 7. Dr.Amanullah Khan Member Director Drugs Testing Laboratory Government of Baluchistan, Quetta 8. Dr.Muhammad Khalid Khan Member Director Drugs Testing Laboratory Government of Khyber Pakhtunkhwa, Peshawar 9. Mr.Saleem Butt Member Director Drugs Testing Laboratory Government of Khyber Pakhtunkhwa, Rawalpindi 10. Mr.Abdus Salam Shah Member Director Drugs Testing Laboratory Government of Sindh, Karachi 11. Shaikh Ansar Ahmad, Member Director Biological Drugs, DRAP 12. Mr.Asif Jalil Member Representative of Medical Device Division 13. Dr.Abdur Rasheed Member Chairman, Quality Control Representative of QA< Division 14. Dr. Obaidullah, Deputy Director General (Reg.I) Secretary
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Dr.Muhammad Khalid Khan, Ghulam Mujtaba and Dr.Muhammad Arshad attended the meeting on 25.03.2016. Dr.Masud-ur-Rehman (DDG Biological), Zaheer-ud-Din M Babar (DDC R.I/R IV), Muhammad Akhter Abbas (DDC/Incharge, PEC), Dr.Hafsa Karam Elahi (DDC,PEC), Muhammad Amin (DDC R.V / DDC,PEC), Tehreem Sara (DDC RRR), Adnan Faisal Saim (DDC,QC), Babar Khan (ADC R.II/RIII), Dr.Ghazanfar Ali Khan (ADC RRR), Salateen Waseem Phillips (ADC,PEC), Muhammad Ansar (ADC,PEC), Rana Ahsan ul Haq (ADC,PEC) and Muneeb Cheema (ADC,Biological) assisted relevant Directors and Secretary of the Board with agenda. Abuzar Faizi Rattu, Nadeem Alamgeer and Shahzad Hussain attended the meeting as observer on behalf of PPMA, Pharma Beauru and PCDA respectively. In addition to routine agenda, following was also discussed and decided:
Registration Board deliberated that drugs for treatment of chronic ailments and drugs which are in short availability should have priority review process and consideration by the Board to ensure their free availability. The Board decided that drugs for treatment of cancer, viral diseases, thalaesemia, immunosuppresants, vaccine and sera, new molecules / formulations, blood factors and bags will be given priority consideration.
Registration Board deliberated that as registration letter is being signed by three officers (concerned section / Division officer, Secretary and Chairman, Registration Board), thus on same analogy letter for cancellation / suspension of registration will also be signed by these officers.
While discussing agenda of Biological drugs, Chairman, Registration Board re-iteriated that separate Board should be constituted as Biological drugs require thorough examination keeping in view nature of products and their sensitive.
Dr.Amanullah Khan, Director Drugs Testing Laboratory, Quetta pointed out that biological products deferred in previous meetings due to certain shortcomings should be placed in agenda of Registration Board meeting after rectification of shortcomings.
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Item No. I: Confirmation of minutes of 256th meeting Registration Board.
256th meeting of Registration Board was held on 03-04th February, 2016. Draft minutes were circulated to all members (who attended the meeting) on 18.02.2016 through e-mail with the request to forward their comments (if any) within 05 days. None of the member forwarded their comments. Decision: Registration Board confirmed minutes of 256th Registration Board meeting.
Item No. II: Cases referred by Pharmaceutical Evaluation & Registration Division Case No.01: Grant of registration for export purpose.
Registration Board discussed cases for grant of registration for export purpose in various meetings, as per following detail: 240th meeting held on 07th November, 2013 approved standard operating procedure for various processes including grant of registration for export purpose, which is as follows: a. Application on Form 5 with required fee as per relevant SRO. b. NOC for CRF clearance. c. Copy of approved section from CLB. d. Copy of last inspection report. e. An undertaking that applied registration is exclusively for export purpose and will not be sold in Pakistan. f. If formulation / product is not registered in Pakistan, then export order from importing country.
241st meeting held on 23-12-2013 discussed grant of registration of export purpose and decided as follows:
a. If formulation is already registered in Pakistan, then Board authorized its Chairman to dispose off the application. b. If formulation is not registered in Pakistan, but has been approved by USFDA, EMA, Australian TGA, regulatory body of Japan or western Europe as drug, then Registration Board will decide the application keeping in view status of the product in aforementioned countries / regulatory authorities. c. If formulation does not fall in above two categories, then applicant will be asked to provide import order from the importing country duly approved by the regulatory
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authority of importing country. Case will be then presented before Registation Board for decision.
246st meeting held on 10-11th December, 2014 discussed grant of registration of export purpose, as follows:
Mr.A Q Javed Iqbal, Director QA < opined that for export purpose only those formulations should be registered, which are already registered in Pakistan. For new fornulations (which are not registered in Pakistan), manufacturers should first conduct stability studies and then registration for export purpose be granted. Prof. Muzammil H Najmi also endorsed it. Registration Board after deliberation decided that inorder to facilitate export of quality drugs (non-me too drugs), export registration will be granted and manufacturer will comply following conditions before export of drug:
Manufacturer will export the product after complying all the conditions as required under Drug Act, 1976 including No objection certificate from concerned DRAP office. Moreover, Federal Inspector of drugs will take sample from each consignemnet for analysis from CDL, Karachi. Manufacturer will also furnish export documents endorsed from custom authorities in order to ensure the export of the product.
Registration Board authorized its Chairman for grant of registration for export purpose on contract manufacturing basis excluding controlled drugs and new drug as per contract manufacturing policy. 254th meeting held on 11-12th November, 2015 discussed grant of registration of export purpose and deliberated that formulations which are approved by reference regulatory authorities will be considered for grant of export registrations. Other formulations (not approved by reference regulatory authorities) will be deferred for detailed deliberations in forthcoming meeting. In 256th meeting held on 03-04th February, 2016, PPMA and Pharma Bureau was again advised to submit proposal for grant of registration for export purpose for those formulations which are not approved by reference regulatory authorities.
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Decision: Registration Board deliberated case for grant of export registration in detail. The Board was apprised that registration applications for pharmaceutical export purpose are being processed on priority basis to facilitate registration of drugs by regulatory authority of importing country. Moreover, requirement for registration of drugs is also different in every importing country and it is responsibility / requirement of regulatory authority of country of import to evaluate the registration application and data submitted by the firm for registration of drugs. For disposal of export registration on priority, Registration Board has already taken following decisions: Authorization to Chairman, Registration Board for grant of export registrations of me too / generic drugs including contract manufacturing permissions.
Grant of registration by Registration Board for non-me too formulations approved by regulatory authorities of reference countries.
Registration Board further decided as follows: Formulations which are not approved by reference regulatory authorities will be considered by the Board if applicant provides evidence of approval status of applied formulation by regulatory authority of importing country.
Formulations which have already been registered for export purposes will be granted to other manufacturers for export purpose.
Export registrations granted with condition of testing by CDL, Karachi will not be mandatory if it is not required by regulatory authority of importing country.
Manufacturer will export the product after complying all the requirements as required under Drug Act, 1976 and relevant rules including No objection certificate from concerned DRAP office.
Manufacturer will also furnish export documents endorsed from custom authorities (if required for any query) in order to ensure the export of the product.
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Case No.02: Cases referred by Pharmaceutical Evaluation Cell
(M. Akhtar Abbas Khan, In-Charge PEC)
New Molecules/ New combinations of M/s CCL Pharmaceuticals Pvt. Ltd, Lahore:-
S/N Brand Name Type of Remarks on Remarks Decision (Proprietary name + Dosage Form the by Form + Strength) formulation Evaluator Initial date, (if any) Composition diary including International Pharmacological Group Fee status in including stringent drug Finished product Specification differential regulatory fee agencies / authorities Demanded Price / Pack size 1. Mirabet Tablet 25mg Form-5-D USFDA Firm Registration Board Tablet Dy. No: Not Approved. submitted considered the Each extended release tablet mentioned MYRBETRIQ Stability application and contains: Dated.19-04- By APGDI Studies referred the stability Mirabegron ………… 25mg 2013 conducted data for onsite investigation by (Urologicals, Urinary Rs.50,000/- as per panel. antispasmodics ) As per SRO decision of Priority 2262 20’s 251st meeting of the Board.
2. Mirabet Tablet 50mg Form-5-D USFDA Firm Registration Board Tablet Dy. No: Not Approved. submitted considered the Each extended release tablet conta mentioned MYRBETRIQ Stability application and Mirabegron ………… 50mg Dated.19-04- By APGDI Studies referred the stability (Urologicals, Urinary 2013 conducted data for onsite investigation by antispasmodics ) Rs.50,000/- under the panel. As per SRO Zone IV-A Priority 2246 20’s conditions.
3. Sita-Met XR Tab 50/500 Form-5-D USFDA Firm has Deferred for Tablet Dy. No: Not Approved. submitted clarification of Each tablet contains: mentioned JANUMET Stability NCE as per Sitagliptin phosphate Dated.08-04- XR Studies DRAP’s Policy monohydrate eq. to 2013 By MERCK conducted Board decision Sitagliptin…...... 50mg Rs.50,000/- SHARP as per
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Metformin HCI………..500mg As per SRO DOHME decision of (Anti Diabetic) 10’s,14’s,30’s 251st meeting of the Board. Priority 2252
4. Sita-Met XR Tab 50/1000 Form-5-D USFDA Firm has Deferred for Tablet Dy. No: Not Approved. submitted clarification of Each tablet contains: mentioned JANUMET Stability NCE as per Sitagliptin phosphate Dated.08-04- XR Studies DRAP’s Policy monohydrate eq. to 2013 By MERCK conducted Board decision Sitagliptin…...... 50mg Rs.50,000/- SHARP as per Metformin As per SRO DOHME decision of HCI……..…..1000mg 10’s,14’s 251st (Anti Diabetic) meeting of the Board. Priority 2251
5. Sita-Met XR Tab 100/1000 Form-5-D USFDA Firm has Deferred for Tablet Dy. No: Not Approved. submitted clarification of Each tablet contains: mentioned JANUMET Stability NCE as per Sitagliptin phosphate Dated.08-04- XR Studies DRAP’s Policy monohydrate eq. to 2013 By MERCK conducted Board decision Sitagliptin…...... 100mg Rs.50,000/- SHARP as per Metformin As per SRO DOHME decision of HCI……..…..1000mg 10’s,14’s 251st (Anti Diabetic) meeting of the Board. Priority 2253
6. Xinib Tablet 1mg Form-5-D USFDA Inlyta by Deferred for Tablet Dy. No: Not Approved. Pfizer confirmation of Each tablet contains: mentioned INLYTA Pakistan is manufacturing By PFIZER Axitinib …………… 1mg Dated.19-04- approved in facility being anti- (Antineoplastic agents) 2013 256th neoplastic drug. Rs.50,000/- meeting. Priority 2247 As per SRO 14’s,30’s 7. Xinib Tablet 5mg Form-5-D USFDA Inlyta by Deferred for Tablet Dy. No: Not Approved. Pfizer confirmation of Each tablet contains: mentioned INLYTA Pakistan is manufacturing By PFIZER Axitinib …………… 5mg Dated.19-04- approved in facility being anti- (Antineoplastic agents) 2013 256th neoplastic drug. Rs.50,000/- meeting. Priority 2265 As per SRO 14’s,30’s
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8. Urocon + Tablets Form-5-D Vesomni (UK) Deferred for Tablet Dy. No: Not clarification of Each tablet contains: mentioned NCE as per Solifenacin succinate Dated.03-12- DRAP’s Policy ……….6mg Tamsulosin HCl (as 2015 Board decision SR pellets)…..0.4mg Rs.50,000/- (Alpha-1 adrenoceptor As per SRO antagonists) 30’s Priority 2745
M/s AGP Private (Ltd)
Following Application of M/s AGP Private (Ltd) was considered in the 254th meeting and the Registration Board for submission of original duly legalized COPP by the concerned embassy of Pakistan. Now the firm has submitted reply in compliance to the decision of the Board.
S. Name and Brand Name Type of International Remarks of Decision No address of (Proprietary name + Form status in PEC manufacturer Dosage Form + Initial date, stringent / Applicant Strength) diary regulatory Composition Fee agencies Pharmacological including Group differential Me-too Finished product fee status Specification Demanded Price / GMP status Pack size as depicted in inspection report (dated)
9. M/s AGP Vimpat 10mg/ml Form-5 (A) Vimpat Firm has Approved (Private) solution for infusion UCB INC submitted Limited. B- Infusion Dy. No: 10mg/ml IV COPP 23 S.I.T.E Each ml of solution 130 dated infusion issued by Karachi. contains: 20-09-2013 EMA UK Lacosamide….10mg 100,000/- dated 3-12- M/s UCB (UCB specs) dated 20- 2012and Pharma SA (Antiepileptic) 09-2013 legalized by Chemin du 20ml Pakistan foriest B Rs.10,818/- High
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1420 Braine- Commission Alleud UK. Belgium
M/s Al-Fazal Pharma Industries (Pvt) Ltd.
Following Application of M/s Al-Fazal Pharma Industries (Pvt) Ltd. was considered in the 245th & 250th meeting and the Registration Board deferred the application in 250th for clarification from firm that applied formulation is either syrup or suspension.. Now the firm has submitted reply in compliance to the decision of the board.
S. Brand Name Type of International Remarks of Decision No. (Proprietary name + Form status in PEC Dosage Form + Initial date, stringent Strength) diary regulatory Composition Fee agencies Pharmacological including Group differential Me-too status Finished product fee Specification Demanded GMP status as Price / Pack depicted in size inspection report (dated)
10. FEPAR Suspension Form-5 Applied Deferred for Approved Each 5ml contains:- 23/05/14 Dy formulation is clarification Albendazole…….100mg No: 1023 approved in by form firm that Anthelmintic 20,000/- Regulatory applied BP Rs. 25/- agency of formulation is Pack of Germany either syrup 10ml or suspension. Xantinil of Miracle Firm has Pharmaceuticals informed that Islamabad the applied formulation is liquid suspension and is registered with multiple manufacturers
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by DRAP. Firm has also submitted the revised master formulation.
M/s Uniferoz, 32/8 Sector 15, Korangi industrial Area, Karachi:
Following Applications of M/s Uniferoz, 32/8 Sector 15,Korangi industrial Area, Karachi. was considered in the 247th meeting and the Board deferred the application for the reason mentioned below. The firm has also provided Registration Certificate of medical device from Sudan and Free sale issued by KFDA. Export registration by DRAP.
S. Brand Name Type of Internationa Observations Decision of Decision No (Proprietary Form l status in M-247th name + Dosage Initial date, stringent Meeting Form + diary regulatory Strength) Fee agencies Composition including Pharmacologica differential Me-too l Group fee status Finished Demanded product Price / Pack GMP status Specification size as depicted in inspection report (dated) 11. Dermapore Form 5 GMP 1. An 1. Deferred Deferred for Non 10 cmx10m inspection undertaking for the Woven Fabric 5 cm x 10m report dated / commitment rectification confirmatio Surgical Tape 2.5 cm x10 15-07-2014. regarding the of n of for Demanded Overall submission of shortcomings approval (Surgical price GMP following, / status in Dressing & has not been compliance before observations reference Bandage) mentioned level rated marketing the in countries. Rs.8000/- as product, as preceding (27/07/2010 good. per column. ) decision of 2. Final Rs.12,000/- the notice for (23/07/2013 Registration rectification ) Board, may of Fee challans be shortcomings
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are submitted for / duplicate consideration observations. Total by Rs.20,000/- the Board: Dy. No. not a) Stability available / studies Duplicate b) dossier Pharmaceuti cal development studies c) Validation of analytical testing methods d) Process validation Label claim and prescribing information being same as approved by reference drug agencies e.g., FDA, TGA, MHLW, EMA and Health Canada. However, firm has submitted SOP’s / data for above mentioned studies which require evaluation and verification. 2. International
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availability has been mentioned as not applicable. Evidence of approval of same product by stringent regulatory authority e.g., FDA, TGA, MHLW, EMA and Health Canada required. 3. Complete details of brands available in Pakistan i.e., same generic, dosage form & strength etc. required. Firm has submitted two brands as me too i.e., Fixomull Stretch and OxyMax (10cm x 10M only) both are unregistered as mentioned by the applicant firm. 4. Evidence of
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approval of section / manufacturin g facility for applied drug required. 5. Complete specifications of container- closure system.
Applications from Pending List
(Evaluator IV: Salateen Waseem Philip)
S/N Name and Brand Name Type of Form International status in Decision address of (Proprietary name + Initial date, diary stringent regulatory manufacturer / Dosage Form + Fee including agencies Applicant Strength) differential fee Composition Demanded Price / Me-too status Pharmacological Pack size Group GMP status as Finished product depicted in Specification inspection report (dated)
12. M/s S.J.&G. Capsule Zinir Form 5 with fee Rs FDA approved Approved Fazul Ellahie 20,000/- Cedax capsules (Pvt.) Ltd, E/46 Each capsule S.I.T.E, Karachi contains:- Rs. 8000/- vide Dy. Xigris-Wilshire Ceftibuten dihydrate # 111 dated 22-08- Priority # 1313 JP eq. to Ceftibuten 2011 GMP compliant 400 mg section vide Rs. 12000/- vide inspection report Cephalosporin Dy. # 1361 dated dated 25-01-2016 Manufacture 04-09-2013 specification Pack size of 10’s 2400/-
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13. -do- Zinir Suspension Form 5 with fee Rs FDA approved Approved Priority # 1313 20,000/- Cedax Each 5ml of reconstituted Rs. 8000/- vide Dy. Xigris-Wilshire suspension contains:- # 12 dated 22-08- Ceftibuten dihydrate 2011 GMP compliant JP eq. to Ceftibuten 90 section vide mg Rs. 12000/- vide inspection report Dy. # 1360 dated dated 25-01-2016 Cephalosporin 04-09-2013 Manufacture specification Pack size of 60ml amber glass bottle as per SRO 14. -do- Zofin-V Syrup Form 5 with fee Rs Rejected for: Priority # 1312 20,000/- Mosegor-V The board Each 10ml contains:- (Novartis) observed Pizotifen (as Rs. 8000/- vide Dy. that off label Hydrogen Maleate) # 20 dated 22-08- GMP compliant use of 0.5mg 2011 section vide pizotifen Thiamine HCl 1.75mg inspection report syrup is Riboflavin Phosphate Rs. 12000/- vide dated 25-01-2016 appetite 2.62mg Dy. # 1278 dated stimulant Pyroxidine HCl 28-08-2013 which is not 1.54mg indicated in Nicotinamide 10.5mg Pack size of any 60ml Rs. 70/- literature. Sedating antihistamin 120ml Rs. 120 Pizotifen is Manufacture indicated in specification cluster headache which is not present among children that’s why pizotifen is not required in syrup dosage form. Formulation is not approved by reference regulatory authorities
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15. -do- Mefnate Tablet Form 5 with fee Rs Artequin-Switzerland Deferred for Priority # 1304 20,000/- the application Each co-blister GMP compliant on Form 5-D contains:- Rs. 8000/- vide Dy. section vide along with 3 tablets Artesunate # 20 dated 22-08- inspection report requisite 200 mg 2011 dated 25-01-2016 documents. 3 tablet Mefloquine HCl eq to Mefloquine Rs. 12000/- vide 250mg Dy. # 1281 dated 28-08-2013 Antimalarial Manufacture Pack size of specification 60ml Rs. 70/- 120ml Rs. 120 16. -do- Tablet Zofin 0.5mg Form 5 with fee Rs MHRA approved Approved Priority # 1301 20,000/- pizotifen 0.5 mg Each film coated tablet, Actavis tablet contains:- Rs. 8000/- vide Dy. Pizotifen (as hydrogen # 17 dated 22-08- maleate) 0.725mg eq 2011 Mosegor (Novartis) to Pizotifen 0.5mg Rs. 12000/- vide GMP compliant Serotonin antagonist Dy. # 1275 dated section vide 5HT2A & 5HT2C / 28-08-2013 inspection report antihistamine/antichol Pack size of dated 25-01-2016 inergic 30’s Rs. 100/- BP Specification 17. M/s Asian Exma Tablet 4mg Form 5 with fee Rs MHRA approved Approved Continental 20,000/- product of Actavis. (Pvt.) Ltd, D-32, Each chewable tablet S.I.T.E II, Super contains:- Rs. 8000/- vide Dy. Myteka-Hilton Highway, Montelukast Sodium # 246 dated 20-06- Karachi (MS) eq. to 2011 GMP compliant Priority # 1558 Montelukast 4mg section vide Rs. 12000/- vide inspection report Leukotriene receptor Dy. # nil dated 31- dated 11-11-2015 antagonist 07-2013 Manufacture specification Pack size of 14’s as per PRC 18. M/s Asian Exma Tablet 10mg Form 5 with fee Rs MHRA approved Rejected as Continental 20,000/- product of Actavis. the (Pvt.) Ltd, D-32, Each chewable tablet formulation is S.I.T.E II, Super contains:- Rs. 8000/- vide Dy. Myteka-Hilton not approved Highway, Montelukast Sodium # 246 dated 20-06- in reference Karachi (MS) eq. to 2011 GMP compliant drug Priority # 1559 Montelukast 10 mg section vide regulatory Rs. 12000/- vide inspection report agencies Leukotriene receptor Dy. # nil dated 31- dated 11-11-2015 antagonist 07-2013 Manufacture Minutes for 257th Registration Board Meeting 16
specification Pack size of 14’s as per PRC
19. M/s MBL Astin Dry Suspension Form 5 with fee Rs WHO recommended Approved Pharma, Plot # 20,000/- formulation B-771/A, Hub Each 5ml of Industrial reconstituted Rs. 8000/- vide Dy. Malasaf-SAAF Trading Estate, suspension contains: # 537 dated 26-04- Balochistan. Artemether…………1 2012 GMP compliant Priority # 1550 5 mg section vide Lumefantrine……….. Rs. 12000/- vide inspection report 90 mg Dy. # nil dated 05- dated 09-10-2015 08-2013 (Anti malarial) Firms Specs Pack size of 30ml Rs. 90/- 20. -do- Tablet Jutromes Form 5 with fee Rs MHRA approved Approved Priority # 1532 500mg 20,000/- brand of Actavis
Each film coated Rs. 8000/- vide Dy. Azomax-Novartis tablet contains: # 724 dated 16-04- Azithromycin 2012 dihydrate eq. to GMP compliant Azithromycin…….50 Rs. 12000/- vide section vide 0 mg Dy. # nil dated 05- inspection report 08-2013 dated 09-10-2015 (Anti biotic) USP Specification Pack size of 2 x 3 blister pack Rs. 270/- 21. -do- Tablet Atox Form 5 with fee Rs MHRA approved Approved Priority # 922 2.5mg/0.025mg 20,000/- brand Lomotil of Mercury Each tablet contains: Rs. 8000/- vide Dy. Pharmaceuticals,UK Diphenoxylate # 159 dated 12-03- hydrochloride………. 2011 Rexotil-Reko 2.5 mg Atropine Rs. 12000/- vide sulphate…..0.025 mg Dy. # nil dated 05- GMP compliant 08-2013 section vide (Antidiarrhoeals) inspection report Manufacture Pack size of dated 09-10-2015 Specification 2 x 3 blister pack Rs. 270/-
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22. M/s CKD Luecas Ointment Form 5 with fee Rs. MHRA approved Approved Pharmaceuticals 0.005% 20,000/- vide Dy.# Cutivate-GSK Pakistan 027 dated 04-01- (Private) Each gram contains: 2013 Limited, 50/28, Fluticasone propionate Cutivate (GSK) Korangi USP ….. 50 mcg Pack size of 5gram Industrial Area, (0.005%w/w) Rs. 55/- GMP compliant Karachi section vide (Corticosteroid) Pack size of 10 inspection report Priority # 2096 In house Specification gram Rs. 105/- dated 09.10.2015 23. M/s CKD Tablet Neubol Form 5 with fee Rs. Japanese formulation Approved Pharmaceuticals 500mcg 20,000/- vide Dy.# Pakistan 1671 dated 04-10- (Private) Each tablet contains: 2012 Alamin (Candid) Limited, 50/28, Mecobalamin Korangi ……..500 mcg Pack size of 5gram GMP compliant Industrial Area, Rs. 55/- section vide Karachi (C0-enzyme-type inspection report vitamin B12) Pack size of 10’s dated 09.10.2015 Priority # 1894 In-house Specification per blister - Rs. 127/- 20’s - Rs. 254.60/- 30’s - Rs. 381.90/- 100’s - Rs. 1273/-
24. M/s Hygeia Tablet Dexfen 300 mg Form 5 with fee Rs. Tablet Seractil 300 Approved Pharmaceuticals, 20,000/- mg manufactured by 295, Industrial Each film coated Rs. 8000/- vide Gebro Pharma Triangles, tablet contains Dy.# 417 dated 18- GmbH, Austria Kahuta Road, Dexibuprofen 300mg 06-2012 available in BNF 68. Islamabad. Priority # 1730 NSAID Rs. 12000/-vide In-house specification Dy# 415 dated 415 Dexifen (ICI) dated 20-02-2013 GMP compliant Pack size of section vide 3 x 10’s / as per inspection report SRO dated 08-12-2015 25. -do- Tablet Helpha 0.5mcg Form 5 with fee Rs. One Alpha – Leo Approved 20,000/- Pharma Priority # 1682 Each tablet contains Alphacalcidol 0.5mcg Rs. 8000/- vide A-Bone (Mission) Dy.# 416 dated 18- Vitamin D3 analogue 06-2012 In-house specification Rs. 12000/-vide Dy# 415 dated 415 dated 20-02-2013
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as per SRO
26. -do- Tablet Helpha 1mcg Form 5 with fee Rs. Approved Priority # 1729 20,000/- Each tablet contains Adela (Getz) Alphacalcidol 1mcg Rs. 8000/- vide Dy.# 416 dated 18- Vitamin D3 analogue 06-2012 In-house specification Rs. 12000/-vide Dy# 415 dated 415 dated 20-02-2013
Pack size of 10’s / as per SRO 27. -do- Tablet Moxan 400mg Form 5 with fee Rs. MHRA approved Approved 20,000/- Avelox Priority # 1687 Each film coated tablet contains Rs. 8000/- vide Locgin (Himont) Moxifloxacin (as HCl) Dy.# 5169 dated USP 400mg 11-06-2012 GMP Compliant Quinolones Rs. 12000/-vide In-house specification Dy# 415 dated 415 dated 20-02-2013
Pack size of 1 x 5’s / as per SRO 28. -do- Tablet Topride 150mg Form 5 with fee Rs. Rejected as the Priority # 1685 20,000/- formulation is Each tablet contains Emptin (Dyson) not approved by Itopride 150mg Rs. 8000/- vide reference drug Dy.# 5171 dated regulatory Antiemetic 11-06-2012 agencies In-house specification Rs. 12000/-vide Dy# 415 dated 415 dated 20-02-2013
Pack size of 100’s / as per SRO 29. -do- Tablet Peride 4mg Form 5 with fee Rs. MHRA approved Approved Priority # 1683 20,000/- Amaryl Each tablet contains Glimperide USP 4mg Rs. 8000/- vide Amaryl (Sanofi) Dy.# 5158 dated Oral Hypoglycemic 11-06-2012 USP specification Rs. 12000/-vide
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Dy# 415 dated 415 dated 20-02-2013
Pack size of 2 x 10’s / as per SRO 30. -do- Tablet Entecave Form 5 with fee Rs. MHRA approved Approved Priority # 1686 20,000/- Braclude tablet Each film coated tablet contains Rs. 8000/- vide Cure-B (Global) Entecavir 0.5mg Dy.# 5158 dated 11-06-2012 Anti Retroviral In-house specification Rs. 12000/-vide Dy# 415 dated 415 dated 20-02-2013
Pack size of 3 x 10’s / as per SRO
31. -do- Tablet Hitor 10mg Form 5 with fee Rs. MHRA approved Approved 20,000/- Lipitor tablet Priority # 1684 Each film coated tablet contains Rs. 8000/- vide Atorex (Dyson) Atorvastatin calcium Dy.# 5168 dated trihydrate USP eq to 11-06-2012 Atorvastatin 10mg Rs. 12000/-vide Dy# 415 dated 415 Lipid regulating drugs dated 20-02-2013 USP specification Pack size of 1 x 10’s / as per SRO 32. -do- Tablet Hitor 20mg Form 5 with fee Rs. MHRA approved Approved Priority # 1734 20,000/- Lipitor tablet Each film coated tablet contains Rs. 8000/- vide Atorex (Dyson) Atorvastatin calcium Dy.# 5168 dated trihydrate USP eq to 11-06-2012 Atorvastatin 20mg Rs. 12000/-vide Lipid regulating drugs Dy# 415 dated 415 USP specification dated 20-02-2013
Pack size of 1 x 10’s / as per SRO
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33. -do- Tablet Rabrazole Form 5 with fee Rs. MHRA approved Approved Priority # 1733 20mg 20,000/- Pariet tablet
Each gastro resistant Rs. 8000/- vide Arpo (Tabros) film coated tablet Dy.# 5168 dated contains 11-06-2012 20mg rabeprazole sodium, equivalent to Rs. 12000/-vide 18.85mg rabeprazole. Dy# 415 dated 415 dated 20-02-2013 Proton Pump Inhibitor In-house specification Pack size of 1 x 14’s / as per SRO 34. -do- Tablet Etoxib 60mg Form 5 with fee Rs. MHRA approved Approved Priority # 1735 20,000/- Arcoxia Tablet Each film coated tablet contains Rs. 8000/- vide Etoxib (Hiranis) Etoricoxib 60 mg Dy.# 5417 dated 18-06-2012 COX 2 Inhibitor In-house specification Rs. 12000/-vide Dy# 415 dated 415 dated 20-02-2013
Pack size of 1 x 10’s / as per SRO 35. -do- Tablet Gemicin Form 5 with fee Rs. FDA approved Approved Priority # 1681 320mg 20,000/- Factive Tablet Rs. 8000/- vide manufactured by Each film coated Dy.# 5163 dated Osceint tablet contains 18-06-2012 Gemifloxacin 320mg Rs. 12000/-vide Floxigem (AGP) Dy# 415 dated 415 Quinolones dated 20-02-2013 In-house specification Pack size of 1 x 7’s / as per SRO 36. -do- Tablet Hiprox 20mg Form 5 with fee Rs. MHRA approved Approved 20,000/- Priority # 1731 Each film coated Gerox (Glitz) tablet contains Rs. 8000/- vide Paroxetine HCl USP Dy.# 5163 dated eq to Paroxetine 20mg 18-06-2012
selective serotonin Rs. 12000/-vide reuptake inhibitors Dy# 415 dated 415 (SSRIs) dated 20-02-2013 USP specification Pack size of 1 x 10’s / as per SRO
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37. -do- Tablet Desdine 5mg Form 5 with fee Rs. MHRA approved Approved Priority # 1732 20,000/- Each film coated Aloret (Mass tablet contains Rs. 8000/- vide Pharma) Desloratidine 5mg Dy.# 419 dated 18- 06-2012 Antihistamine In-house specification Rs. 12000/-vide Dy# 415 dated 415 dated 20-02-2013
Pack size of 10’s / as per SRO 38. -do- Tablet Gluconol Form 5 with fee Rs. Deferred as Priority # 1756 20,000/- Product is Each tablet contains under review / Phloroglucinol BP Rs. 8000/- vide Colospa (Platinum) expert opinion 80mg Dy.# 476 dated 27- 06-2012 Antispasmodics In-house specification Rs. 12000/-vide Dy# 415 dated 415 dated 20-02-2013
Pack size of 3x10’s / as per SRO 39. -do- Tablet Levetam Form 5 with fee Rs. MHRA approved Approved Priority # 1754 250mg 20,000/- Keppra, a brand of UCB, Belgium Each film coated Rs. 8000/- vide tablet contains Dy.# 476 dated 27- Eppra (Global) Levetiracetam USP 06-2012 250mg Rs. 12000/-vide Antispasmodics Dy# 415 dated 415 USP specification dated 20-02-2013
Pack size of 3x10’s / as per SRO
40. -do- Tablet Levetam Form 5 with fee Rs. MHRA approved Approved Priority # 1755 500mg 20,000/- Keppra, a brand of UCB, Belgium Each film coated Rs. 8000/- vide tablet contains Dy.# 476 dated 27- Eppra (Global) Levetiracetam USP 06-2012 500mg Rs. 12000/-vide Antispasmodics Dy# 415 dated 415 USP specification dated 20-02-2013
Minutes for 257th Registration Board Meeting 22
Pack size of 3x10’s / as per SRO
41. -do- Tablet Sperid Form 5 with fee Rs. MHRA approved Approved Priority # 1753 20,000/- Risperdal, a brand of Each film coated Janssen, UK tablet contains Rs. 8000/- vide Risperidone USP 2mg Dy.# 481 dated 27- Dawn (Mega) 06-2012 Benzisoxazole derivatives Rs. 12000/-vide USP specification Dy# 415 dated 415 dated 20-02-2013
Pack size of 3x10’s / as per SRO 42. -do- Tablet Hytorac 30mg Form 5 with fee Rs. Rejected as Priority # 1752 20,000/- formulation is Each tablet contains not approved Ketoralac Rs. 8000/- vide by any trometamine 30mg Dy.# 473 dated 27- reference 06-2012 regulatory Potent NSAID authority In-house specification Rs. 12000/-vide Dy# 415 dated 415 dated 20-02-2013
Pack size of 1 x10’s / as per SRO 43. -do- Capsule Hepretin Form 5 with fee Rs. MHRA approved Approved Priority # 1737 60mg 20,000/- formulation
Each capsule contains Rs. 8000/- vide Dulan (Hilton) Duloxetine USP Dy.# 5407 dated 60mg 18-06-2012 GMP compliant section selective serotonin Rs. 12000/-vide and norepinephrine Dy# 415 dated 415 reuptake dated 20-02-2013 inhibitor (SSNRI) USP Specification Pack size of 10’s / as per SRO Source of Duloxetine enteric coated 17% pellets:- M/s Vision Pharmaceuticals, Plot # 22-23, Industrial Triangle Kahuta Road, Islamabad.
Minutes for 257th Registration Board Meeting 23
44. -do- Capsule Hepretin Form 5 with fee Rs. MHRA approved Approved Priority # 1736 30mg 20,000/- formulation
Each capsule contains Rs. 8000/- vide Dulan (Hilton) Duloxetine USP 30mg Dy.# 5407 dated 18-06-2012 selective serotonin and norepinephrine Rs. 12000/-vide reuptake Dy# 415 dated 415 inhibitor (SSNRI) dated 20-02-2013 USP specification Pack size of 10’s / Source of Duloxetine as per SRO enteric coated 17% pellets:- M/s Vision Pharmaceuticals, Plot # 22-23, Industrial Triangle Kahuta Road, Islamabad.
45. -do- Capsule Marine Form 5 with fee Rs. MHRA approved Approved Priority # 1759 200mg 20,000/- formulation
Each capsule contains Rs. 8000/- vide ASPA (Highnoon) Mebeverine 200mg Dy.# 5407 dated 18-06-2012 selective serotonin and norepinephrine Rs. 12000/-vide reuptake Dy# 415 dated 415 inhibitor (SSNRI) dated 20-02-2013 In-house specification Pack size of 10’s / Source of Modified as per SRO release Mebeverine 50% pellets:- M/s Vision Pharmaceuticals, Plot # 22-23, Industrial Triangle Kahuta Road, Islamabad.
46. -do- Capsule Direin 50mg Form 5 with fee Rs. Deferred as Priority # 1758 20,000/- Diora (Getz) product under Each capsule contains review / expert Diacerein……. 50 mg Rs. 8000/- vide opinion Dy.# 472 dated 27-
Minutes for 257th Registration Board Meeting 24
Anthraquinone 06-2012 Derivative In-house specification Rs. 12000/-vide Dy# 415 dated 415 dated 20-02-2013
Pack size of 3x10’s / as per SRO 47. M/s Pliva Tablet Plidome 10mg Form 5 with fee Rs. MHRA approved Approved. Pakistan (Pvt.) 20,000/- formulation Firm will Ltd, Plot# B-77, Each film coated mention Hub Industrial tablet contains Rs. 8000/- vide Domel (Barrett) warnin on Trading Estate, Domperidone B.P Dy.# 683 dated 10- outer cartoon. Balochistan. 10mg 05-2012 GMP compliant section vide Priority # 1580 antiemetic Rs. 12000/-vide inspection report In-house specification Dy# 612 dated 02- dated 13-10-2015 08-2013
Pack size of 5 blisters of 10 tablets Rs. 215/-
48. -do- Tablet Plivazith 500 Form 5 with fee Rs. MHRA approved Approved Priority # 1579 mg 20,000/- formulation
Each film coated Rs. 8000/- vide Azomax (Novartis) tablet contains Dy.# 683 dated 10- Azithromycin 05-2012 GMP compliant Dihydrate USP eq to section vide Azithromycin 500mg Rs. 12000/-vide inspection report Dy# 612 dated 02- dated 13-10-2015 Macrolides 08-2013 USP specification Pack size of blister of 3 tablets Rs. 160/- Blister of 6 tablets 275/- 49. -do- Tablet Plivadine 40 Form 5 with fee Rs. FDA approved Approved Priority # 1575 mg 20,000/- Pepcid, a brand of Marathon Each film coated Rs. 8000/- vide pharmaceuticals tablet contains Dy.# 677 dated 10- Famotidine USP 05-2012 Concid (Reko) 40mg Rs. 12000/-vide GMP compliant H2 Blockers Dy# 612 dated 02- section vide USP specification 08-2013 inspection report dated 13-10-2015 Pack size of 10 Minutes for 257th Registration Board Meeting 25
tablets Rs. 160/-
50. -do- Plivadine Suspension Form 5 with fee Rs. FDA approved Deferred as as Priority # 1573 10 mg/5ml 20,000/- Pepcid, a brand of the product is Marathon not approved by Each 5ml contains Rs. 8000/- vide pharmaceuticals reference drug Famotidine USP Dy.# 677 dated 10- regulatory 10mg 05-2012 Concid (Reko) agencies. Internationally H2 Blockers Rs. 12000/-vide GMP compliant available USP specification Dy# 612 dated 02- section vide formulation is 08-2013 inspection report dry powder for dated 13-10-2015 suspension in Pack size of 10 the strength of tablets Rs. 160/- 40 mg/ 5 ml. (Ref: US FDA) The firm shall follow decision of 250th meeting of Registration Board. 51. -do- Cemofloxacin Dry Form 5 with fee Rs. FDA approved Rejected as the Priority # 1576 Suspension 20,000/- Ciproxin formulation is 125mg/5ml not approved by Rs. 8000/- vide Novidat (Sami) reference drug Each 5ml of Dy.# 683 dated 10- regulatory reconstituted 05-2012 GMP compliant agencies in such suspension contains section vide formuation Ciprofloxacin Rs. 12000/-vide inspection report HCl.H2O eq to Dy# 612 dated 02- dated 13-10-2015 Ciprofloxacin 125mg 08-2013
Quinolones Pack size of 60ml In-house specification bottle Rs. 90/- 52. -do- Cemofloxacin Dry Form 5 with fee Rs. FDA approved Deferred as Priority # 1574 Suspension 20,000/- Ciproxin product under 250mg/5ml review Rs. 8000/- vide Novidat (Sami) Each 5ml of Dy.# 684 dated 10- Master reconstituted 05-2012 GMP compliant formulation of suspension contains section vide brand leader, Ciprofloxacin Rs. 12000/-vide inspection report Ciproxin consist HCl.H2O eq to Dy# 612 dated 02- dated 13-10-2015 of ciprofloxacin Ciprofloxacin 250mg 08-2013 base powder for reconstitution in Quinolones Pack size of 60ml a special diluent. In-house specification bottle Rs. 160/-
Minutes for 257th Registration Board Meeting 26
53. -do- Baxacim forte Form 5 with fee Rs. FDA approved Approved Priority # 1572 200mg/5ml Dry 20,000/- Suprax, Lupin Suspension Rs. 8000/- vide Caricef (Sami) Each 5ml of Dy.# 683 dated 10- reconstituted 05-2012 GMP compliant Oral suspension contains Dry Powder Cefixime trihydrate Rs. 12000/-vide (Cephalosporin) USP eq to Cefixime Dy# 612 dated 02- section vide 200mg 08-2013 inspection report dated 13-10-2015 Cephalosporin Pack size of 30ml USP specification bottle Rs. 300/- 54. -do- Plivazith Dry Powder Form 5 with fee Rs. FDA approved Deferred for Priority # 1570 for oral Suspension 20,000/- product of Pfizer verification of 200mg/5ml production Rs. 8000/- vide Spell (Tagma) equipment and Each 5ml of Dy.# 683 dated 10- procedure of reconstituted 05-2012 GMP compliant manufacturing suspension contains section vide of taste Taste masked Rs. 12000/-vide inspection report masked Granules of Dy# 612 dated 02- dated 13-10-2015 granmules of Azithromycin 08-2013 Azithromycin. dihydrate USP (Micronized) eq to Pack size of 15ml Azithromycin 200mg bottle Rs. 300/-
Macrolides USP specification 55. -do- Capsule Plivazith Form 5 with fee Rs. MHRA approved Approved Priority # 1581 250mg 20,000/- Zithromax
Each hard gelatin Rs. 8000/- vide Azit (Raazee) capsule contains Dy.# 681 dated 10- Azithromycin 05-2012 GMP compliant Dihydrate USP section vide 262.05mg eq to Rs. 12000/-vide inspection report Azithromycin 250mg Dy# 612 dated 02- dated 13-10-2015 08-2013 Macrolides USP specification Pack size of Blister of 6 capsules Rs. 180/-
Blister of 10 capsules 260/-
Minutes for 257th Registration Board Meeting 27
56. -do- Plidome Oral Liquid Form 5 with fee Rs. MHRA approved Approved. Priority # 1578 Suspension 20,000/- Firm will Pelton (Global) mention Each ml contains Rs. 8000/- vide warnin on Domperidone B.P Dy.# 679 dated 10- outer cartoon. 1mg 05-2012 GMP compliant Antiemetics Rs. 12000/-vide section vide In-house specification Dy# 612 dated 02- inspection report 08-2013 dated 13-10-2015
Pack size of 60ml bottle Rs. 42/-
120ml pack Rs. 84/- 57. M/s Zephyr Cefclav Plus Oral Form 5 with fee Rs. Rejected as Pharmatec (Pvt.) Suspension 20,000/- formulation is Ltd, A-39, not approved S.I.T.E, Super Each 5ml of re- Rs. 8000/- vide by reference Highway Karachi constituted suspension Dy.# 1144 dated regulatory Priority # 1766 contains 29-06-2012 authorities Cefixime (as Trihydrate) 200mg Rs. 12000/-vide Clavulanic acid (as Dy# 596 dated potassium) 125mg dated 01-08-2013
Antibiotic Pack size as per In-house specification SRO
58. -do- Cefclav Oral Form 5 with fee Rs. Rejected as Suspension 20,000/- this Priority # 1765 formulation is Each 5ml of re- Rs. 8000/- vide not approved constituted suspension Dy.# 1145 dated by reference contains 29-06-2012 regulatory Cefixime (as authorities Trihydrate) 100mg Rs. 12000/-vide Clavulanic acid (as Dy# 589 dated potassium) 62.5mg dated 01-08-2013
Antibiotic Pack size as per In-house specification SRO 59. -do- Maloff 15/90 Oral Form 5 with fee Rs. WHO recommended Approved Suspension 20,000/- formulation Priority # 1723 Each 5ml of re- Rs. 8000/- vide constituted suspension Dy.# 1038 dated Gen M (Genix) contains 29-06-2012 Artemether 15mg GMP compliant Minutes for 257th Registration Board Meeting 28
Lumefantrine 90mg Rs. 12000/-vide section vide Dy# 579 dated inspection report Antimalarial dated 01-08-2013 dated 11-08-2015 In-house specification Pack size 30ml as per SRO 60. -do- Maloff 20/120 Oral Form 5 with fee Rs. Rejected as Suspension 20,000/- this Priority # 1722 formulation is Each 5ml of re- Rs. 8000/- vide not approved constituted suspension Dy.# 1038 dated by eith contains 29-06-2012 reference Artemether 20mg regulatory Lumefantrine 120mg Rs. 12000/-vide authorities or Dy# 579 dated WHO Antimalarial dated 01-08-2013 In-house specification Pack size 30mlas per SRO 61. -do- Capsule Cefclav Plus Form 5 with fee Rs. Rejected as 20,000/- formulation is Each capsule contains not approved Cefixime (as Rs. 8000/- vide by reference Trihydrate) 200mg Dy.# 1146 dated regulatory Clavulanic acid (as 29-06-2012 authorities potassium) 125mg Rs. 12000/-vide Antibiotic Dy# 588 dated In-house specification dated 01-08-2013
Pack size as per SRO
62. -do- Tablet Rheoxen Form 5 with fee Rs. FDA approved Deferred as the Priority # 1724 20,000/- Vimovo proposed Each film coated formulation is tablet contains Rs. 8000/- vide not yet Naproxen BP 375mg Dy.# 1144 dated registered in Esomeprazole (as 29-06-2012 GMP compliant Pakistan. The Magnesium section vide firm shall apply trihydrate) 20 mg Rs. 12000/-vide inspection report on prescribed Dy# 596 dated dated 11-08-2015 Form 5-D and NSAID/ Proton Pump dated 01-08-2013 requisite Inhibitor documents In-house specification Pack size as per SRO
63. M/s Lowitt Capsule Atorin 50mg Form 5 with fee Rs. Deferred as Pharma (Pvt.) 20,000/- product is Ltd, 24- Each capsule contains under review /
Minutes for 257th Registration Board Meeting 29
Industrial Estate, Diacerein … 50 mg Dy. # 1049 dated Artrodar (Highnoon) expert opinion Hayatabad, 18-12-2012 Peshawar. Anti Rheumatics GMP compliant Priority # 2062 In house specification Pack size section dated 06-07- 30’s Rs. 1000/- 2015 Or fixed by Competent authority
64. -do- Tablet Dazemep plus Form 5 with fee Rs. FDA approved Approved Priority # 2060 2/30 20,000/- Duetact
Each tablet contains Dy. # 1050 dated Glimepiride 2mg 18-12-2012 Poze-G (AGP) Pioglitazone (as HCl) 30mg Pack size & Pack GMP compliant proce as fixed section dated 06-07- Anti Rheumatics by Competent 2015 USP specification authority
65. -do- Tablet Dazemep plus Form 5 with fee Rs. FDA approved Approved Priority # 2061 4/30 20,000/- Duetact
Each tablet contains Dy. # 1051 dated Glimepiride BP 4mg 18-12-2012 Poze-G (AGP) Pioglitazone (as HCl) 30mg Pack size & Pack GMP compliant price as fixed by section dated 06-07- Anti Rheumatics Competent 2015 USP specification authority
66. -do- Tablet Lowspa 135mg Form 5 with fee Rs. MHRA approved Approved Priority # 2063 20,000/- Colofac (Mylan) Each coated tablet contains Dy. # 1048 dated Mebeverine HCl BP 18-12-2012 Baver (Glitz) 135mg Pack size & Pack GMP compliant Anti Spasmodics price as fixed by section dated 06-07- BP specification Competent 2015 authority 67. -do- Tablet Lobastin 10mg Form 5 with fee Rs. Kestinlyo (Almirall, Approved Priority # 2064 20,000/- France) Each tablet contains Ebastine BP 10mg Dy. # 1047 dated Beyond (Scotmann) 18-12-2012 Antihistamine GMP compliant
Minutes for 257th Registration Board Meeting 30
In-house specification Pack size & Pack section dated 06-07- price as fixed by 2015 Competent authority 68. -do- Tablet Lobastin 20mg Form 5 with fee Rs. Kestinlyo (Almirall, Approved Priority # 2065 20,000/- France) Each tablet contains Ebastine BP 20mg Dy. # 1054 dated 18-12-2012 Beyond (Scotmann) Antihistamine In-house specification Pack size & Pack GMP compliant price as fixed by section dated 06-07- Competent 2015 authority 69. -do- Tablet R-Zole 10mg Form 5 with fee Rs. MHRA approved Approved Priority # 2066 20,000/- Pareit, a brand of Each enteric coated Eisasi, UK tablet contains Dy. # 1046 dated Rabeprazole sodium 18-12-2012 APT (Nexus) 10mg equivalent to Rabeprazole 9.42mg Pack size & Pack GMP compliant price as fixed by section dated 06-07- Antihistamine Competent 2015 In-house specification authority
70. -do- Tablet R-Zole 20mg Form 5 with fee Rs. MHRA approved Approved Priority # 2067 20,000/- Pareit, a brand of Each enteric coated Eisasi, UK tablet contains Dy. # 1056 dated Rabeprazole sodium 18-12-2012 APT (Nexus) 20mg equivalent to Rabeprazole 18.85mg Pack size & Pack GMP compliant price as fixed by section dated 06-07- Antihistamine Competent 2015 In-house specification authority
71. -do- Tablet Fungirid Form 5 with fee Rs. TGA approved Approved Priority # 2068 125mg 20,000/- Lamisil Tablets (Novartis) Each tablet contains Dy. # 1052 dated Terbinafine (as HCl) 18-12-2012 Cutis (Tabros) USP 125mg Pack size & Pack GMP compliant Antifungals price as fixed by section dated 06-07- USP specification Competent 2015 authority 72. -do- Tablet Fungirid Form 5 with fee Rs. TGA approved Approved Priority # 2069 250mg 20,000/- Lamisil Tablets (Novartis)
Minutes for 257th Registration Board Meeting 31
Each tablet contains Dy. # 1057 dated Terbinafine (as HCl) 18-12-2012 Cutis (Tabros) USP 250mg Pack size & Pack GMP compliant Antifungals price as fixed by section dated 06-07- USP specification Competent 2015 authority 73. -do- Tablet Spaslow Form 5 with fee Rs. Deferred as Priority # 2071 20,000/- Anafortan PLus product under Each tablet contains (AGP) review / expert Phloroglucinol Dy. # 1053 dated opinion Hydrate 80mg 18-12-2012 Trimethylphloroglucin GMP compliant ol 80mg Pack size & Pack section dated 2014 price as fixed by Antispasmodics/antich Competent olinergic authority In-house specification
74. M/s Merck Tablet Sustin 10mg Form 5 with fee Rs. MHRA approved Deferred for last (Private) 20,000/- Crestor, a brand of inspection report Limited, 7-jail Each film coated AstraZeneca conducted Road, Quetta. tablet contains Rs. 8000/- vide Dy. within one year. Priority # 1353 Rosuvastatin calcium # 379 dated 20-09- Rolip (Hilton) eq to Rosuvastatin 10 2011 mg GMP compliant Rs. 12000/- dated section dated 14-04- Lipid Lowering Agent 05-09-2013 2014 (firm explained In-house specification that no inspection Pack size 10’s conducted by DRAP Rs. 200/- after that date)
Per tablet Rs. 20/- 75. M/s Merck Tablet Sustin 5mg Form 5 with fee Rs. MHRA approved Deferred for last (Private) 20,000/- Crestor, a brand of inspection report Limited, 7-jail Each film coated AstraZeneca conducted Road, Quetta. tablet contains Rs. 8000/- vide Dy. within one year. Priority # 1352 Rosuvastatin calcium # 379 dated 20-09- Rolip (Hilton) eq to Rosuvastatin 5 2011 mg Rs. 12000/- dated 05-09-2013 Lipid Lowering Agent In-house specification Pack size 10’s Rs. 120/-
Per tablet Rs. 12/-
Minutes for 257th Registration Board Meeting 32
76. M/s CSH Tablet Tadalis 20 mg Form 5 with fee Rs. MHRA approved Deferred as firm Pharmaceuticals 20,000/- vide Dy. # Cialis, a brand of Eli did not apply on – North (Pvt.) Each film coated 1027 dated 10-12- Lilly correct form. It Ltd, 38-A, tablet contains 2012 needs to apply Industrial Estate, Tadalafil 20mg on prescribed Hayattabad, Pack size 1 x 10’s Form 5-D for Peshawar PDE5 inhibitor Rs. 3250/- new molecules Priority # 2032 In-house with requisite specification Pack size 1 x 4’s documents. Rs. 1400/-
Rs 350/- per tablet
77. -do- Tablet Tadalis 10 mg Form 5 with fee Rs. MHRA approved Deferred as firm Priority # 2031 20,000/- vide Dy. # Cialis, a brand of Eli did not apply on Each film coated 1025 R & I dated Lilly correct form. It tablet contains 10-12-2012 needs to apply Tadalafil 10mg on prescribed Pack size 1 x 10’s Form 5-D for PDE5 inhibitor Rs. 1800/- new molecules In-house with requisite specification Pack size 1 x 4’s documents. Rs. 750/-
Rs 187.50/- per tablet
78. -do- Tablet Tadalis 5 mg Form 5 with fee Rs. MHRA approved Deferred as firm Priority # 2030 20,000/- vide Dy. # Cialis, a brand of Eli did not apply on Each film coated 1028 R & I dated Lilly correct form. It tablet contains 10-12-2012 needs to apply Tadalafil 5mg on prescribed Pack size 1 x 10’s Form 5-D for PDE5 inhibitor Rs. 900/- new molecules In-house Pack size 1 x 4’s with requisite specification Rs. 400/- documents. Rs 100/- per tablet 79. -do- Tablet Tadalis 2.5 mg Form 5 with fee Rs. MHRA approved Deferred as firm Priority # 2029 20,000/- vide Dy. # Cialis, a brand of Eli did not apply on Each film coated 1026 R & I dated Lilly correct form. It tablet contains 10-12-2012 needs to apply Tadalafil 2.5mg on prescribed Pack size 1 x 10’s Form 5-D for PDE5 inhibitor Rs. 700/- new molecules In-house with requisite specification Pack size 1 x 4’s documents. Rs. 280/-
Rs 70/- per tablet Minutes for 257th Registration Board Meeting 33
80. -do- Tablet Valitra 5 mg Form 5 with fee Rs. MHRA approved Deferred as firm Priority # 2024 20,000/- vide Dy. # Levitra, a brand of did not apply on Each film coated 1018 R & I dated Bayer AG correct form. It tablet contains 10-12-2012 needs to apply Verdenafil (as HCl) on prescribed 5mg Pack size 1 x 10’s Form 5-D for Rs. 1400/- new molecules PDE5 inhibitor with requisite In-house Pack size 1 x 4’s documents. specification Rs. 560/-
Rs 140/- per tablet 81. -do- Tablet Valitra 10 mg Form 5 with fee Rs. MHRA approved Deferred as firm Priority # 2025 20,000/- vide Dy. # Levitra, a brand of did not apply on Each film coated 1020 R & I dated Bayer AG correct form. It tablet contains 10-12-2012 needs to apply Verdenafil (as HCl) on prescribed 10mg Pack size 1 x 10’s Form 5-D for Rs. 2150/- new molecules PDE5 inhibitor with requisite In-house Pack size 1 x 4’s documents. specification Rs. 880/-
Rs 220/- per tablet
82. -do- Tablet Valitra 20 mg Form 5 with fee Rs. MHRA approved Deferred as firm Priority # 2026 20,000/- vide Dy. # Levitra, a brand of did not apply on Each film coated 1019 R & I dated Bayer AG correct form. It tablet contains 10-12-2012 needs to apply Verdenafil (as HCl) on prescribed 20mg Pack size 1 x 10’s Form 5-D for Rs. 2300/- new molecules PDE5 inhibitor with requisite In-house Pack size 1 x 4’s documents. specification Rs. 950/-
Rs 237/- per tablet
83. -do- Tablet Rivox 10 mg Form 5 with fee Rs. MHRA approved Approved Priority # 2021 20,000/- vide Dy. # Xarelto, a brand of Each film coated 1023 R & I dated Bayer tablet contains 10-12-2012 Rivaroxaban 10mg Xarelto, Bayer
Minutes for 257th Registration Board Meeting 34
Pack size 1 x 5’s Anticoagulant - Factor Rs. 3400 Xa inhibitor In-house Rs 680/- per tablet specification
84. -do- Tablet Rivox 15 mg Form 5 with fee Rs. MHRA approved Approved Priority # 2022 20,000/- vide Dy. # Xarelto, a brand of Each film coated 1021 R & I dated Bayer tablet contains 10-12-2012 Rivaroxaban 15mg Xarelto, Bayer Pack size 1 x 5’s Reg # 072549 Anticoagulant - Factor Rs. 4950 (Import) Xa inhibitor In-house Rs 990/- per tablet specification
85. -do- Tablet Rivox 20 mg Form 5 with fee Rs. MHRA approved Approved Priority # 2023 20,000/- vide Dy. # Xarelto, a brand of Each film coated 1022 R & I dated Bayer tablet contains 10-12-2012 Rivaroxaban 20mg Xarelto, Bayer Pack size 1 x 5’s Anticoagulant - Factor Rs. 6550 Xa inhibitor In-house Rs 1310/- per tablet specification
86. -do- Tablet Profile 5 mg Form 5 with fee Rs. MHRA approved Approved Priority # 2027 20,000/- vide Dy. # Procoralan, a brand Each film coated 1016 R & I dated of Servier tablet contains 10-12-2012 5 mg ivabradine Sivab (Getz) (equivalent to 5.390 Pack size 1 x 14’s mg ivabradine as Rs. 980 hydrochloride). Rs 70/- per tablet Heart Rate Reducing agent In-house specification 87. -do- Tablet Profile 7.5 mg Form 5 with fee Rs. MHRA approved Approved Priority # 2028 20,000/- vide Dy. # Procoralan, a brand Each film coated 1017 R & I dated of Servier tablet contains 10-12-2012 7.5 mg ivabradine Sivab (Getz) (equivalent to 8.085 Pack size 1 x 14’s mg ivabradine as Rs. 1150 hydrochloride). Rs 82.15/- per
Minutes for 257th Registration Board Meeting 35
Heart Rate Reducing tablet agent In-house specification
88. -do- Capsule DISE 50mg Form 5 with fee Rs. Deferred as Priority # 2033 20,000/- vide Dy. # Dibro (Winbrain) product under Each Capsule contains 1024 R & I dated review / Diacerein 50mg 10-12-2012 expert opinion
Anthraquinone Pack size 3 x 10’s Derivatives Rs. 840 In-house specification Rs 28/- per capsule
89. M/s NabiQasim Tablet Listor – Form 5 with fee Rs. FDA approved Approved Industries H150/12.5 20,000/- vide Dy. # Tekturna HCT, a (Private) 423 dated 28-01- brand of Novartis Limited, 17/24, Each film coated 2013 Korangi tablet contains Skiren plus (Getz) Industrial Area, Aliskiren Pack size 10’s, Korangi, Karachi hemifumarate 150mg 14’s, 20’s & 28’s GMP compliant Priority # 1963 Hydrochlorthiazide as per PRC section dated 08-09- 12.5mg 2015
Renin Inhibitor with diuretic In-house specification
90. -do- Tablet Listor – Form 5 with fee Rs. FDA approved Approved Priority # 1963 H300/25 20,000/- vide Dy. # Tekturna HCT, a 428 dated 28-01- brand of Novartis Each film coated 2013 tablet contains Skiren plus (Getz) Aliskiren Pack size 10’s, hemifumarate 300mg 14’s, 20’s & 28’s GMP compliant Hydrochlorthiazide as per PRC section dated 08-09- 25mg 2015
Renin Inhibitor with diuretic In-house specification
91. -do- Tablet Listor – H Form 5 with fee Rs. FDA approved Approved Priority # 1964 150/25 20,000/- vide Dy. # Tekturna HCT, a 428 dated 28-01- brand of Novartis Each film coated 2013 tablet contains Skiren plus (Getz) Aliskiren Pack size 10’s, hemifumarate 150mg 14’s, 20’s & 28’s GMP compliant
Minutes for 257th Registration Board Meeting 36
Hydrochlorthiazide as per PRC section dated 08-09- 25mg 2015
Renin Inhibitor with diuretic In-house specification
92. -do- Tablet Listor – H Form 5 with fee Rs. FDA approved Approved Priority # 1976 300/12.5 20,000/- vide Dy. # Tekturna HCT, a 419 dated 28-01- brand of Novartis Each film coated 2013 tablet contains Skiren plus (Getz) Aliskiren Pack size 10’s, hemifumarate 300mg 14’s, 20’s & 28’s GMP compliant Hydrochlorthiazide as per PRC section dated 08-09- 12.5mg 2015
Renin Inhibitor with diuretic In-house specification
93. -do- Tablet Alron 25mg Form 5 with fee Rs. MHRA approved Approved. Priority # 1517 20,000/- vide Dy. # Inspra 25mg Tablet Product shall swapped Each film coated 387 dated 22-11- be tablet contains 2011 & 16-09-2013 Macrenone (Macter) manufcatured Eplerenone USP 25 in Tablet mg Pack size 10’s & (General) 30’s as per PRC Section as the Steroidal antimineralo product corticoid doesn’t In-house specification possess any steroidal / hormonal acitivity. 94. -do- Tablet Diuret 25mg Form 5 with fee Rs. FDA approved Approved Priority # 1396 20,000/- vide Dy. # product Each tablet contains 218 dated 22-11- Hydrochlorothiazide, 2011 & 16-09-2013 Duiza (Zafa) USP 25mg Pack size 10’s & Diuretic 30’s as per PRC USP specification
95. -do- Tablet Zidin 20mg Form 5 with fee Rs. EMA approved Approved Priority # 1966 20,000/- vide Dy. # product swapped Each film coated 2035 dated 05-11- tablet contains 2012 Vasteral (Servier ) Trimetazidine dihydrochloride 20mg Pack size 10’s & 30’s as per PRC
Minutes for 257th Registration Board Meeting 37
Anti anginal In house specification
96. -do- Neurocetam syrup Form 5 with fee Rs. Available in france Deferred as Priority # 1977 20% 20,000/- vide Dy. # product under swapped 859 dated 19-09- Nootropil review Each 5ml contains 2013 Piracetam 1 gm Pack size 120ml Neuronal metabolic as per PRC modulator In house specification
97. -do- Purified water for oral Form 5 with fee Rs. Available in UK Deferred for Priority # 1364 suspension 20,000/- vide Dy. # clarification swapped 354 dated 17-10- Purified water regarding Each pack contains 2011 & 13-12-2013 (Indus) intended use Purified water BP of product Pack size 10ml, Solvent 15ml, 20ml & 40ml BP specification as per PRC
98. -do- Capsule Uripro 0.4mg Form 5 with fee Rs. FDA approved Approved Priority # 1965 20,000/- Flomax Each capsule contains vide Dy. # 627 Tamsulosin HCl USP dated 15-02-2012 Tamsolin (Getz) 0.4 mg (Modified release pellets) Pack size 10’s, & GMP compliant 20’s as per PRC section dated 08-09- Selective alpha 2015 blockers In-house specification
Source of pelles M/s Surge Laboratories, 10-km, Faisalabad Road, batti district sheikhupura 99. M/s Amarant Amazin Dry Form 5 with fee Rs. WHO recommended Deferred For Pharmaceuticals Suspension 20mg/5ml 20,000/- vide Dy. # Views / (Private) 423 dated 28-01- ZILGIT (GLITZ) Opinion Of Limited, 158-D, Each 5ml of 2013 WHO, Tore, reconstituted Inspection report Pakistan GadapRoad, suspension contains Pack size & Pack dated 04-11-2015 Super Highway, Zinc Sulphate prizes as per Karachi Monohydrate USP eq PRC Priority # 1924 to elemental Zinc 20mg
Antidiarrheal
Minutes for 257th Registration Board Meeting 38
USP specification
100. -do- Amazin Dry Form 5 with fee Rs. WHO recommended Approved Priority # 1923 Suspension 10mg/5ml 20,000/- vide Dy. # 1301 dated 19-10- ZILGIT (GLITZ) Each 5ml of 2012 reconstituted Inspection report suspension contains Pack size & pack dated Zinc Sulphate prize as per PRC 04-11-2015 Monohydrate USP eq to elemental Zinc 10mg
Antidiarrheal USP specification
101. -do- Amazin OD Tablet 10 Form 5 with fee Rs. WHO recommended Approved Priority # 1928 mg 20,000/- vide Dy. # 1304 dated 19-10- ZINXUS Each dispersible tablet 2012 (Ferozsons) contains Zinc Sulphate Pack size & pack Monohydrate USP eq prize as per PRC to elemental Zinc 10mg
Antidiarrheal USP specification
102. -do- Amazin OD Tablet 20 Form 5 with fee Rs. WHO recommended Approved Priority # 1925 mg 20,000/- vide Dy. # 1303 dated 19-10- ZINXUS Each dispersible tablet 2012 (Ferozsons) contains Zinc Sulphate Pack size & pack Monohydrate USP eq prize as per PRC to elemental Zinc 20mg
Anti-cholinergic USP specification
103. M/s Noa Hemis Tablet Musrin-D Form 5 with fee Rs. FDA approved Deferred as firm Pharmaceuticals, 7.5mg 20,000/- vide Dy. # ENABLEX shall apply this Plot # 154, 2257 R&I dated 18- product on Form Sector 23, Each extended release 12-2012 GMP compliant 5-D and Korangi tablet contains section requisite Industrial Area, Darifenacin (as HCl) Pack size documents Karachi 15mg 10’s MRP 550
Minutes for 257th Registration Board Meeting 39
20’s MRP 1100 Priority # 2075 Anti-cholinergic 30’s MRP USP specification 165000
104. M/s Noa Hemis Tablet Musrin-D Form 5 with fee Rs. FDA approved Deferred as firm Pharmaceuticals, 15mg 20,000/- vide Dy. # ENABLEX shall apply this Plot # 154, 2256 R&I dated 18- product on Form Sector 23, Each extended release 12-2012 GMP compliant 5-D and Korangi tablet contains section requisite Industrial Area, Darifenacin (as HCl) Pack size documents Karachi 15mg 10’s MRP 1100 20’s MRP 2200 Priority # 2076 Antidiarrheal 30’s MRP 3100 USP specification
105. -do- Capsule Gabatil 50 Form 5 with fee Rs. FDA approved Approved Priority # 2077 mg 20,000/- vide Dy. # Lyrica 2255 R&I dated 18- Each capsule contains 12-2012 Gabica (Getz) Pregabalin 50mg Pack size of 14’s GMP compliant Antiepileptic PRC section Firm’s specification
Routine cases - Veterinary Liquid Injection
106. M/s Intervac Dorafas 1% Injection Form 5 with Dectomax, Approved (Pvt.) Ltd, 18km fee Rs. Zoeitis,USA Lahore Each ml contains 20,000/- Sheikhupura Doramectin 10mg Road, Rs. 8000/- Doramec (Selmore) Sheikhupura Anthelmintics vide Dy. # In-house specification 722 dated GMP compliant as per Priority # 282 Veterinary 02-07-2012 inspection report dated 09-12-2015 Rs. 12000/- vide Dy. # 717 dated 25-07-2013
Pack size 10ml, 20ml, 50ml, 100ml & 200ml decontrolled
Minutes for 257th Registration Board Meeting 40
107. -do- Intervac SEL-E Injection Form 5 with Approved Priority # 281 fee Rs. Each ml contains 20,000/- Selfrol (Selmore) Vitamin E 75mg Registration # 034579 Sodium Selenite 0.66mg Rs. 8000/- vide Dy. # Vitamins/amino acids 720 dated In-house specification 02-07-2012 Veterinary Rs. 12000/- vide Dy. # 717 dated 25-07-2013
Pack size 10ml, 20ml, 50ml, 100ml decontrolled 108. -do- Penafas Injection Form 5 with Deferred for Priority # 319 fee Rs. confirmation Each ml contains 20,000/- Pronil (Selmore) from Prednisolone (as acetate) vide Dy. # Licensing 7.5mg 278 dated Division, Dexmethasone (as sodium 13-11-2012 DRAP, for phosphate) 2.5mg segregated Pack size section for Steroids 10ml, 30ml, steroid In-house specification 50ml, 100ml injection Veterinary & 200ml manufacturin decontrolled g
109. -do- Coligent Injection Form 5 with Deferred for Priority # 261 fee Rs. evaluation of Each 100ml contains 20,000/- Gentacolt (Attabak) nephrotoxicit Gentamicin Sulphate 10gm y data Colistin Sulphate 100 MIU Rs. 8000/- vide Dy. # Antibiotics 357 dated In-house specification 13-11-2012 Veterinary Rs. 12000/- vide Dy. # 717 dated 25-07-2013
Pack size 10ml, 30ml, 50ml, 100ml & 200ml
Minutes for 257th Registration Board Meeting 41
decontrolled
110. -do- Tylogent-C Injection Form 5 with Approved Priority # 262 fee Rs. Each 100ml contains 20,000/- Anti-CRD(Attabak) Gentamicin Sulphate 5gm Colistin Sulphate 60 MIU Rs. 8000/- Tylosin tartrate 10gm vide Dy. # 356 dated Antibiotics 13-11-2012 In-house specification Veterinary Rs. 12000/- vide Dy. # 717 dated 25-07-2013
Pack size 10ml, 25ml, 50ml, 100ml & 200ml decontrolled
111. -do- Pronifas Injection Form 5 with Approved Priority # 318 fee Rs. Each ml contains 20,000/- Pronil (Selmore) Diminazine Aceturate vide Dy. # 105mg 277 dated Antipyrine 131mg 13-11-2012
Antiparasitics In-house specification Pack size Veterinary 10ml, 20ml, 50ml, 100ml decontrolled
Veterinary Oral Liquid 112. -do- Bromosol oral liquid 10% Form 5 with fee Approved Priority # 258 Rs. 20,000/- Each ml contains Bomexan Bromhexine HCl 10mg Rs. 8000/- vide (Vigilant) Dy. # 360 dated Reg # 039949 expectorant 02-07-2012 BP specification
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Veterinary Rs. 12000/- vide Dy. # 717 dated 25-07-2013
Pack size of plastic bottles 100ml, 200ml, 500ml, 1000ml decontrolled 113. -do- Amentasol 10% oral liquid Form 5 with fee Deferred for Priority # 259 Rs. 20,000/- confirmation Each 1000ml contains Amentos 10% of approval Amantadine HCl 100gm Rs. 8000/- vide (Leads) status of Dy. # 353 dated proposed antiviral 02-07-2012 dosage form In-house specification (Oral liquid) Veterinary Rs. 12000/- vide in Pakistan. Dy. # 717 dated 25-07-2013
Pack size of plastic bottles 100ml, 200ml, 500ml, 1000ml decontrolled 114. -do- Amentasol 5% oral liquid Form 5 with fee Deferred for Priority # 279 Rs. 20,000/- confirmation Each 1000ml contains Amentos 10% of approval Amantadine HCl 50gm Rs. 8000/- vide (Leads) status of Dy. # 353 dated proposed antiviral 02-07-2012 dosage form In-house specification (Oral liquid) Veterinary Rs. 12000/- vide in Pakistan. Dy. # 717 dated 25-07-2013
Pack size of plastic bottles 100ml, 200ml, 500ml, 1000ml decontrolled 115. -do- Intrasol plus oral liquid Form 5 with fee Deferred as Priority # 279 Rs. 20,000/- product Each 1000ml contains Intracin plus under Enrofloxacin HCl 100gm Rs. 8000/- vide powder (Leads) review. Amantadine HCl 40gm Dy. # 358 dated Colistin Sulphate 35gm 23-05-2012
Antiviral/antibacterial Rs. 12000/- vide In-house specification Dy. # 717 dated Veterinary 25-07-2013 Minutes for 257th Registration Board Meeting 43
Pack size of plastic bottles 100ml, 200ml, 500ml, 1000ml decontrolled Veterinary Water soluble powder 116. -do- Oxy-floro water soluble Form 5 with fee Approved Priority # 280 powder Rs. 20,000/- Floxybar 30 WSP Each gram contains Rs. 8000/- vide (Baariq) Oxytetracycline HCl 150mg Dy. # 723 dated Florfenicol 150mg 02-07-2012
Antibacterial Rs. 12000/- vide In-house specification Dy. # 717 dated Veterinary 25-07-2013
Pack size of plastic bottles 100gm, 250gm, 500gm, 1000gm, 2500gm decontrolled Veterinary Oral Liquid 117. M/s Baariq Ciprobar-C Oral Liquid Form 5 with fee Approved Pharmaceuticals, Rs. 20,000/- Plot # 600, Each 100ml contains Eg Engro Sundar Industrial Enrofloxacin BP 10gm Rs. 8000/- vide (Elegance) Estate, Sundar Aminophylline 4gm Dy. # 27 dated 03- Raiwind Road, Guaiphenesin BP 10gm 08-2012 GMP compliant Lahore section dated Priority # 285 Antibacterial/bronchodilator/ Rs. 12000/- vide 15.05.2015 expectorant Dy. # 902 dated In-house specification 29-07-2013 Veterinary Pack size of plastic bottles 100ml, 250ml, 500ml, 1000ml decontrolled 118. -do- Amantaflox-C20 oral liquid Form 5 with fee Deferred Priority # 253 Rs. 20,000/- as Each 100ml contains Bio-Enrocol-A product Enrofloxacin BP 10gm Rs. 8000/- vide (Biogen) under Colistin Sulphate 4 gm Dy. # 326 dated review. Amantadine HCl 4gm 18-05-2012 GMP compliant section Antibacterial/Antiviral Rs. 12000/- vide 15.05.2015 In-house specification Dy. # 898 dated Minutes for 257th Registration Board Meeting 44
Veterinary 29-07-2013
Pack size of plastic bottles 100ml, 250ml, 500ml, 1000ml decontrolled 119. -do- Selenium plus oral solution Form 5 with fee Approved Priority # 252 Rs. 20,000/- Each 100ml contains Fentin-23 (Nawal) Florfenicol 23gm Rs. 8000/- vide Colistin Sulphate 50 MIU Dy. # 331 dated GMP compliant 18-05-2012 section Antibacterial/Anticoccidial In-house specification Rs. 12000/- vide Veterinary Dy. # 907 dated 29-07-2013
Pack size of plastic bottles 100ml, 250ml, 500ml, 1000ml decontrolled 120. -do- Dxitylo-C Oral Liquid Form 5 with fee Approved Priority # 251 Rs. 20,000/- CRD LIQUID Each 1000ml contains (DMAARSON) Tylosin Tartrate 10gm Rs. 8000/- vide Doxycycline Hyclate 20gm Dy. # 335 dated GMP compliant Colistin Sulphate 1000 MIU 18-05-2012 section
Antibacterial/Antibiotics Rs. 12000/- vide In-house specification Dy. # 908 dated Veterinary 29-07-2013
Pack size of plastic bottles 100ml, 500ml, 1000ml, 2500ml decontrolled 121. -do- Amobar-S Oral Liquid Form 5 with fee Approved Priority # 284 Rs. 20,000/- Gumbobak Each 100ml contains (Attabak) Ammonium Chloride 65gm Rs. 8000/- vide Methionone 10gm Dy. # 28 dated 03- GMP compliant Sorbitol 5gm 08-2012 section Vitamin A 250,000 IU Vitamin C 10gm Rs. 12000/- vide Dy. # 895 dated Vitamin/Aminoacid 29-07-2013 In-house specification Veterinary Pack size of Minutes for 257th Registration Board Meeting 45
plastic bottles 100ml, 500ml, 1000ml, 2500ml decontrolled 122. -do- Hepabar Oral Liquid Form 5 with fee Approved Priority # 283 Rs. 20,000/- Hepacare (Selmore) Each ml contains L-Carnitine 50mg Rs. 8000/- vide GMP compliant Betain 20mg Dy. # 32 dated 03- section Inositol 7mg 08-2012 Choline chloride 100mg Rs. 12000/- vide Sorbitol 200mg Dy. # 901 dated Magnesium Sulphate 10mg 29-07-2013
Electrolyte/Aminoacid Pack size of In-house specification plastic bottles Veterinary 100ml, 500ml, 1000ml, 2500ml decontrolled Veterinary Water Soluble Powders 123. -do- Spectolin 100 Water Soluble Form 5 with fee Approved Priority # 288 Powder Rs. 20,000/- Linco-S 100 Powder (Attabak) Each 150 gram powder Rs. 8000/- vide contains Dy. # 30 dated 03- GMP compliant Lincomycin HCl 33.30gm 08-2012 section Spectinomycin HCl 66.70gm Rs. 12000/- vide Antibiotics Dy. # 899 dated In-house specification 29-07-2013 Veterinary Pack size of plastic bottles 100gm, 250gm, 500gm, 1000gm, 2500gm decontrolled 124. -do- Diuriq Water Soluble Form 5 with fee Approved Priority # 256 Powder Rs. 20,000/- Diurile WSP (Manhattan) Each 100 gram powder Rs. 8000/- vide contains Dy. # 329 dated GMP compliant Methenamine 95gm 18-05-2012 section Vitamin B1 0.80gm Rs. 12000/- vide Vitamin B2 0.92gm Dy. # 896 dated Vitamin K3 0.2gm 29-07-2013
Vitamins Pack size of In-house specification plastic bottles Veterinary 100gm, 250gm,
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500gm, 1000gm, 2500gm decontrolled 125. -do- Solubar Water Soluble Form 5 with fee Approved Priority # 256 Powder Rs. 20,000/- Nobi solurenel powder (Noble Each 100 gram powder Rs. 8000/- vide Pharma) contains Dy. # 328 dated Hexamethylene Tetramine 18-05-2012 GMP compliant 95.5gm Rs. 12000/- vide section Riboflavin 2.0gm Dy. # 911 dated Calcium pentothenate 29-07-2013 0.50gm Nicotinamide 1.50gm Pack size of plastic bottles Anticoccidal/antibacterial 100gm, 250gm, In-house specification 500gm, 1000gm, Veterinary 2500gm decontrolled 126. -do- Ethrodox-T Water Soluble Form 5 with fee Approved Priority # 287 Powder Rs. 20,000/- Super Leva (Breeze) Each 100 gram powder Rs. 8000/- vide contains Dy. # 29 dated 03- GMP compliant Levamisole 15% 08-2012 section Rs. 12000/- vide Anthelmentic Dy. # 900 dated In-house specification 29-07-2013 Veterinary Pack size of plastic bottles 100gm, 250gm, 500gm, 1000gm, 2500gm, 5kg, 10kg, 25kg decontrolled 127. -do- ADEKBAR-C Water Form 5 with fee Deferred Priority # 254 Soluble Powder Rs. 20,000/- Symodek for (symans) clarificatio Each 1000 gram powder Rs. 8000/- vide n for contains Dy. # 336 dated GMP compliant solubility Vitamin A 200,000,00 IU 18-05-2012 section of Vitamin Vitamin D3 200,00,00 IU Rs. 12000/- vide A & D (fat Vitamin E 6gm Dy. # 915 dated soluble Vitamin K3 5gm 29-07-2013 vitamins) Vitamin C 5gm as the firm Pack size of is claiming Vitamins plastic bottles the product In-house specification 100gm, 250gm, as water Veterinary 500gm, 1000gm, soluble
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2500gm, decontrolled
128. -do- VITARIQ SUPER Water Form 5 with fee Deferred Priority # 255 Soluble Powder Rs. 20,000/- Vita sol super for (GSK) clarificatio Each 300 gram powder Rs. 8000/- vide n for contains Dy. # 332 dated GMP compliant solubility Vitamin A 60,000,00 IU 18-05-2012 section of Vitamin Vitamin D3 120,00,00 IU Rs. 12000/- vide A & D (fat Vitamin E 480 IU Dy. # 913 dated soluble Vitamin K3 2700gm 29-07-2013 vitamins) Vitamin B1 375mg as the firm Vitamin B2 6000mg Pack size of is claiming Vitamin B6 1800mg plastic bottles the product Vitamin B12 9000mcg 100gm, 300gm, as water Vitamin C 3000mg 500gm, 1000gm, soluble Folic acid 600mg 2500gm, Nicotinic acid 3000mg decontrolled Ca-D-pantothenate 9000mg
Vitamins In-house specification Veterinary
129. -do- Lincobar-E Water Soluble Form 5 with fee Approved Priority # 286 Powder Rs. 20,000/- Chlorocept (D- Maarson) Each gram contains Rs. 8000/- vide Chlortetracycline HCl Dy. # 33 dated 03- GMP compliant 200mg 08-2012 section Neomycin Sulphate 60mg Rs. 12000/- vide Streptomycin Sulphate 20mg Dy. # 894 dated Colistin Sulphate 10mg 29-07-2013
Antibiotics Pack size of In-house specification plastic bottles Veterinary 100gm, 250gm, 500gm, 1000gm, 2500gm, decontrolled Veterinary Oral Liquid 130. M/s Evergreen Terivet Oral Liquid Form 5 with fee Approved Pharmaceuticals Rs. 20,000/- vide Trima S.A (Pvt.) Ltd, 69- Each 100ml contains vide Dy. # 1258 (Westmont) 70/B, Main Trimethoprim 8% dated 21-12-2012 Glaxo Town Sulphadiazine 30% GMP compliant Industrial Estate, Ammonium Chloride 10% Pack size of section dated 17- 20 km, Ferozepur Colistin Sulphate BP 5% plastic bottles 12-2015 Road, Lahore. Career QC 100ml 100ml, 250ml, Minutes for 257th Registration Board Meeting 48
Priority # 323 500ml, 1000ml Antibiotics decontrolled In-house specification Veterinary
131. -do- Enflox Oral Liquid Form 5 with fee Approved Priority # 322 Rs. 20,000/- vide Floxicol (Biogen) Each 100ml contains vide Dy. # 1260 Colistin Sulphate BP 50 dated 21-12-2012 GMP compliant MIU section dated 17- Enrofloxacin 20% w/v Pack size of 12-2015 plastic bottles Antibacterial 100ml, 250ml, In-house specification 500ml, 1000ml Veterinary decontrolled
Replies of deferred cases of previous meetings
S/N Name and Brand Name Type of International Deferred in Decision address of (Proprietary name + Form status in meeting of manufactur Dosage Form + Initial date, stringent RB due to er / Strength) diary regulatory following Applicant Composition Fee agencies shortcoming Pharmacological including s Group differential Me-too status Finished product fee Specification Demanded GMP status as Price / Pack depicted in size inspection report (dated)
132. M/s Tablet Selar 5 mg Form 5 MHRA approved Deferred in Approved NabiQasim Rs. 20,000/- Eldepryl-Orion 256th RB Industries Each tablet contains Vide Dy. No. meeting for (Private) Selegiline (as HCl) 1433 dated Jumex (Sanofi) following Limited USP 5 mg 24-07-2013 points located at GMP compliant The 17/24, Monoamine oxidase – Pack of 10’s section vide quantity of Korangi B Inhibitor & 50’s as per inspection report active Industrial PRC dated 08-09-2015 ingredient in Area, (USP Specification) master Korangi formulation is Karachi. not correct (quantity Priority No. per tab is 10
Minutes for 257th Registration Board Meeting 49
1005 from mg). 2454 swapped Commitment required as per decision of RB. Latest inspection report required. Firm needs to clarify for implementati on of In-house finished product specification while the product is available in USP Pharmacopoe ia.
133. do- Tablet Selar 10 mg Form 5 with MHRA approved Deferred in Approved prescribed Eldepryl-Orion 256th RB Each tablet contains fee Rs. meeting for Priority Selegiline (as HCl) 20,000/- Jumex (Sanofi) following No.1360 USP 10 mg Dy. No. points 1428 dated GMP compliant from Monoamine oxidase – 24-07-2013 section 2459 B Inhibitor The quantity swapped Pack of 10’s of (USP Specification) & 50’s as per active PRC ingredient in master formulation is not correct
Commitmen t required as per Decision of RB.
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Latest inspection report required
Firm needs to clarify for implementat ion of In-house finished product specification while the product is available in USP Pharmacopo eia.
134. -do- Tablet Zypin 5mg Form 5 with TGA approved Deferred in Approved prescribed Film coated 256th RB Each film coated fee Rs. tablet Zyprexa, meeting for Priority No. tablet contains 20,000/- a product of eli following 879 from Olanzapine 5mg Dy. No. lilly. points 2460 1427 dated swapped Thiobenzodiazepine 24-07-2013 Clarification Second generation Olanzia needed Antipsychotics Pack size (Werrick) in master 10’s & 30’s formulation USP specification as per because PRC innovator brand is not a film coated tablet while firm claims film coated tablets.
Commitmen t required as per
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Decision of RB.
Latest inspection Report required.
Firm needs to clarify for implementat ion of In-house finished product specification while the product is available in USP Pharmacopo eia. 135. do- Tablet Zypin 7.5mg Form 5 with TGA approved Deferred in Approved . prescribed Film coated 256th RB Priority No. Each film coated fee Rs. tablet Zyprexa, meeting for 880 from tablet contains 20,000/- a product of eli following 2455 Olanzapine 7.5mg Dy. No. lilly. points swapped 1427 dated Thiobenzodiazepine 24-07-2013 Clarification Second generation Olanzia needed Antipsychotics (Werrick) in master Pack size formulation USP specification 10’s & 30’s because as per innovator PRC brand is not a film coated tablet while firm claims film coated tablets.
Commitmen t
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required as per Decision of RB.
Latest inspection Report required.
Firm needs to clarify for implementat ion of In-house finished product specification while the product is available in USP Pharmacopo eia.
136. -do- Tablet Zypin 10mg Form 5 with TGA approved Deferred in Approved . prescribed Film coated 256th RB Priority No. Each film coated fee Rs. tablet Zyprexa, meeting for 881 from tablet contains 20,000/- a product of eli following 2456 Olanzapine 10mg Dy. No. lilly. points swapped 1431 dated Thiobenzodiazepine 24-07-2013 Clarification Second generation Olanzia needed Antipsychotics (Werrick) in master Pack size formulation USP specification 10’s & 30’s because as per innovator PRC brand is not a film coated tablet while firm claims film coated
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tablets.
Commitmen t required as per Decision of RB.
Latest inspection Report required.
Firm needs to clarify for implementat ion of In-house finished product specification while the product is available in USP Pharmacopo eia. 137. M/s MYCODERM Form-5 TGA approved Deferred in Approved . Nabiqasim Tablets 125mg Lamisil 125mg 248th RB Industries Dy.No:2144 Tablets meeting for (Pvt) Each tablet contains: dated06-12- (Novartis) final notice Limited, Terbinafine as 10 of 30 days hydrochloride……12 8000/- dated Cutis (Tabros) Karachi for 5mg 04-12-10 12,000/- rectification Fungicidal dated 22-07- of below 13 mentioned Manufacturer shortcoming As per PRC/- s/ Pack of 10’s observations .
1. Evidence of approval
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of same generic, dosage form and strength in USFDA, TGA, MHLW, EMA and Health Canada needs to be submitted .
138. M/s Le PANGAB Capsules Form-5 with LYRICA Deferred in Approved Mendoza 50mg fee 20,000/- Capsules (25, 50, 254th RB Plot No. 7, vide Dy. No 75, 100, meeting for: Sector 23 Each capsule Nil dated 26- 150,200, 225 and Latest GMP Korangi contains: 01-2010 300mg) inspection Pregabalin…50mg &12000 US FDA Industrial report. dated 02-02- Area Anti-epileptic 15 GABICA Undertaking Karachi Capsules (50, 75, approved in st Manufacturer Rs. 660/ pack 100, 150 and 251 of 14’s 300mg) meeting of Getz registration board.
139. -do- PANGAB Capsules Form-5 with LYRICA Deferred in Approved 100mg fee 20,000/- Capsules (25, 50, 254th RB vide Dy. No 75, 100, meeting for: Each capsule Nil dated 26- 150,200, 225 and contains: 01-10 300mg) Latest GMP Pregabalin…100mg Rs. 12000/- US FDA inspection dated 02-02- report. Anti-epileptic 15 GABICA Undertaking Capsules (50, 75, approved in Manufacturer Rs. 1200/ 100, 150 and 251st meeting pack of 14’s 300mg) of registration Getz board.
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140. M/s Capsule Phlozed SR Form 5 Catafilm – Deferred in Approved Adamjee 100mg Rs. 20,000/- Novartis (France) 254th RB with change Pharmaceut + 80,000/- meeting for of brand icals (Pvt.) Each Capsule dated 15-11- Legalized name Ltd. Plot # contains 2010 &30- Phlogin GMP status Diclofenac Sodium 07-2013 & (Brookes) of source of 39, Sector (32% w/w enteric 04-08-2015 pellets. 15, Korangi coated pellets) Stability data Industrial equivalent to Pack size of International Area, Diclofenac Sodium 50 x 10’s availability of Karachi. 100mg capsule/ as same dosage per SRO form in NSAID reference (Manufacture SRAs. Specification) Source of pellets Glukem Pharmaceuticals (Pvt.) Ltd, Plot # 205/2A, IDA, Phase II, Cheriapally, Hyderabad. 141. -do- Capsule Phlozed Form 5 Catafilm – Deferred in Approved 50mg Rs. 20,000/- Novartis (France) 254th with change + 80,000/- meeting of of brand Each Capsule dated 15-11- RB for name contains 2010 &30- Phlogin Legalized Diclofenac Sodium 07-2013 & (Brookes) (32% w/w enteric 04-08-2015 GMP coated pellets) status of equivalent to Pack size of source of Diclofenac Sodium 50 x 10’s pellets. 50mg capsule/ as NSAID per SRO Stability (Manufacture data Specification) Internatio Source of pellets nal Glukem availabilit Pharmaceuticals y of same (Pvt.) Ltd,Plot # dosage 205/2A, IDA, Phase form in II, Cheriapally, reference Hyderabad. SRAs.
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142. M/s Noa Tablet Stamux 20mg Form 5 MHRA approved Deferred in Approved Hemis Rs. 20000/- Pentoloc- 256th meeting Pharmaceuti Each gastro resistant vide Novartis of RB for cals, Plot # (enteric coated) tablet Dy. No. 165 completion of 154, Sector contains dated 17-09- Praze (Medisave) application 23, Korangi Pantoprazole Sodium 2011 & 10- w.r.t Industrial sesquihydrate USP 04-2014 GMP compliant following Area,Karachi 22.56mg eq to section vide shortcomings: Pantoprazole 20mg Pack size of inspection report - Priority list 14’s Rs. of To provide No.1341 Proton Pump 335/- panel dated 02- complete Inhibitor 02- description of USP specifications 2015. dosage form either film coated / enteric coated etc. To provide quantity of salt as well as base per dose and batch size. Official monographs/ Reference pharmacopeia required for active and inactive ingredient in the master formulation. Reference of finished Product specification alongwith procedure of analysis.
143. -do- Tablet Gabamin Form 5 Deferred in Rejected as Priority list Rs. 20000/- 256th RB proposed No.1340 Each film coated vide Dy. Gabmin meeting for formulation tablet contains No. 164 (Pharmix) completion is not Gabapentin USP dated 17-09- of approved by any reference 300 mg 2011 GMP compliant application regulatory Mecobalamin MS section vide w.r.t authority 500mcg Pack size of inspection Following 14’s Rs. report of shortcoming
Minutes for 257th Registration Board Meeting 57
Co-enzyme Vitamin 160/- panel dated 02- s:- B12 02- To furnish Firms specifications 2015. approval status of same dosage form in reference regulatory authorities. To furnish master Formulation with amount of base as well as salt per unit dose and per batch. Official monographs/ Reference pharmacopei a required for active and inactive ingredient in the master formulation. Reference of finished Product specification Alongwith procedure of analysis.
Minutes for 257th Registration Board Meeting 58
144. -do- Tablet Flexibon Form 5 Deferred for Deferred for Priority list Rs. 20000/- GMP compliant completion complete No.1335 Each tablet vide section vide of description of contains:- Dy. No. 168 inspection application dosage form Gastro-resistant dated 17-09- report of w.r.t and complete manufacturin core containing 2011 & 10- panel dated 02- Following g method, diclofenac sodium 04- 02- shortcoming indication 50mg surrounded 2014 2015. s:- To by an outer mantle furnish containing 200mcg Pack size of approval misoprostol. 20’s Rs. status of 350/- same dosage Anti acne form in Firms specifications reference regulatory authorities. 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 pharmacopei a required for active and inactive
Minutes for 257th Registration Board Meeting 59
ingredient in the master formulation. Reference of Finished product Specificatio n alongwith procedure of analysis. 145. -do- Tablet Migrip 50 mg Form 5 Imigran Radis – Deferred for Deferred. Priority list Rs. 20000/- GSK (MHRA) confirmation The firm No.1346 Each film coated vide of shall apply dispersable tablet Dy. No. 160 me too status on prescribed contains dated 17-09- Form 5-D Sumatripan (as 2011 & 10- along with succinate) 50 mg 04- requisite 2014 document. 5HT agonist Pack size of Firms specifications 6’s Rs. 525/- 146. -do- Tablet Migrip 100 mg Form 5 Imigran Radis – Deferred for Deferred. Priority list Rs. 20000/- GSK (MHRA) confirmation The firm No.1339 Each film coated vide of shall apply dispersable tablet Dy. No. 160 me too status on prescribed contains dated 17-09- Form 5-D Sumatripan (as 2011 & 10- along with succinate)100 mg 04- requisite 2014 document. 5HT agonist Firms specifications 147. M/s Ahad Lignosafe Injection Form 5 MHRA Deferred in Approved Pharmaceut 04/07/2013 approved 251st icals Each ml contains:- Dy. No. 511 Lidocaine HCl meeting of Limited, Lignocaine HCl Rs. 20000/- injection Board for 13km, (USP)…20mg 20mg/1ml(2% following: Gomal (2%w/v). As per w/v), a brand of The Firm University, SRO / Mercury has applied Multan (Local anaesthetic) 1ml×25 Pharma Ireland. for 1ml Road, Dera (USP Spec.s) ’s PL 02848/0177 ampoule Ismail while the Khan, KPK Lidoject formulation (Surge Pharma) is not available in 1ml ampoule in Pakistan and
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reference agencies. Specifiations of API & excipients need to be submitted.
148. M/s Gallop G-Aero Sol IV Form-5 Clenil Deferred for Deferred for Water Infusion Dy. No: 3456 0.8mg/2ml confirmation confirmation Science dated. Nebulizer of me too of approval 404, Sundar Each 2ml contains:- 18-05-2015 Solution – 2ml status and status by Industrial Beclomethasone Rs.20,000/- single dose approval reference Estate Diproponate…0.8mg status of same regulatory vials for aerosol Lahore dosage form authorities (Corticosteroid) Rs.400/- manufactured in reference Manufacturer’s 5x2ml by Cheisi-Italy regulatory Specifications authority. Clenil-Chiesi- Pakistan 149. -do- G-Nebu Sol IV Form-5 MHRA. Deferred for Approved Infusion Dy. No: 3461 Approved confirmation dated.18-05- Respontin of me too in Each 2ml contains:- 2015 Nebules-GSK LDPE Ipratropium Rs.20,000/- packing in Bromide… 0.5218mg Atem-Clenil same strength eq to Ipratropium Rs.400/5x2m 0.5mg l
Anticholinergic Oral inhalation solution via a nebuliser. B.P Specifications
Minutes for 257th Registration Board Meeting 61
IMPORT CASES:-
S/N Name and Brand Name Type of Form Remarks / Decision address of (Proprietary name + Initial date, Observations manufacturer / Dosage Form + Strength) diary Applicant Composition Fee including Pharmacological Group differential fee Finished product Demanded Specification Price / Pack size
International status in stringent regulatory agencies
Me-too status
GMP status as depicted in inspection report (dated) 150. - Importer - Anti-CCRD Veterinary Oral Form 5-A 1. Sole agency Deferred for the Al-Asar Solution Rs. 100,000/- agreement confirmation of Enterprises – vide Dy. No. issued dated me too status and House # 2574/A, Each 100 ml contains 181 dated 16- 23-05-2011. approval status in Sarai Street, Enrofloxacin 9000mg 04-2012 & Dy. 2. GMP certificate reference Justice Hameed Bromhexine 1000mg No. 875 dated regulatory of product Colony, Nishtar Dexamethasone 50mg 10-05-2013 authority and Road, Multan. issued dated original legalized Antibacterial/ anti- Pack size of 13-11-2014 CoPP / GMP, Country of inflammatory mucolytic bottles 90ml, valid for two FSC Import/ In-house Specification 120ml, 250ml, years. Manufacturer 500ml, 1 L, 5 L 3. GMP Vemedime inspection Veterinary Anti-CCRD report of the Medicine Import (Spain) manufacturer export joint stock (Vietnam) issued dated Company 10th March 07 April 30th St., 2015. Ninh Kieu District, Cantho 4. WHO GMP City, Vietnam. certificate issued valid till 03rd September 2016.
Minutes for 257th Registration Board Meeting 62
151. - Importer - Vimefloro FDP Veterinary Form 5-A 1. Sole agency Deferred for the Al-Asar Oral Solution Rs. 100,000/- agreement confirmation of Enterprises – vide Dy. No. issued dated 23- me too status and House # 2574/A, Each 100 ml contains 194 dated 16- 05-2011. approval status in Sarai Street, Florfenicol 10000mg 04-2012 & Dy. 2. GMP certificate reference Justice Hameed Doxycycline 5000mg No. 875 dated regulatory of product Colony, Nishtar Prednisolone 500mg 10-05-2013 authority and Road, Multan. issued dated original legalized Antibacterial/ anti- 29-09-2015 CoPP / GMP, Country of inflammatory Pack size of valid for two FSC Import/ In-house Specification bottles 90ml, years. Manufacturer 120ml, 250ml, 3. GMP Vemedime 500ml, 1 L, 5 L inspection Veterinary report of the Medicine Import Vimefloro FDP manufacturer export joint stock (S & E issued dated Company Agriventures, 10th March 07 April 30th St., Inc., 2015. Ninh Kieu Phillipines) District, Cantho 4. WHO GMP City, Vietnam. certificate issued valid till 03rd September 2016.
152. - Importer - Vimefloro FDP Veterinary Form 5-A 1. Sole agency Deferred for the Al-Asar Injection Rs. 100,000/- agreement confirmation of Enterprises – vide Dy. No. issued dated me too status and House # 2574/A, Each 100 ml contains 194 dated 16- 23-05-2011. approval status in Sarai Street, Florfenicol 10000mg 04-2012 & Dy. 2. GMP certificate reference Justice Hameed Doxycycline 5000mg No. 875 dated regulatory of product Colony, Nishtar Prednisolone 500mg 10-05-2013 authority and Road, Multan. Lidocaine HCl 1000mg issued dated original legalized 29-09-2015 CoPP / GMP, Country of Route of Administration: IM Pack size of valid for two FSC Import/ bottles 10ml, years. Manufacturer Antibacterial/ anti- 20ml, 50ml, 3. GMP Vemedime inflammatory 100ml inspection Veterinary In-house Specification report of the Medicine Import Vimefloro FDP manufacturer export joint stock (S & E issued dated Company Agriventures, 10th March 07 April 30th St., Inc., 2015. Ninh Kieu Phillipines) District, Cantho 4. WHO GMP
Minutes for 257th Registration Board Meeting 63
City, Vietnam. certificate issued valid till 03rd September 2016.
153. - Importer - Colinorcin Veterinary Oral Form 5-A Sole agency Deferred for the Al-Asar Solution Rs. 100,000/- agreement issued confirmation of Enterprises – vide Dy. No. dated 23-05-2011. me too status and House # 2574/A, Each 1000 ml contains 186 dated 16- GMP certificate approval status in Sarai Street, Colistin Sulfate 25,000,000 04-2012 & Dy. of product issued reference Justice Hameed IU No. 875 dated dated 29-05-2015 regulatory Colony, Nishtar Lincomycin HCl 10,000mg 10-05-2013 valid for two years. authority and Road, Multan. GMP inspection original legalized Antibacterial report of the CoPP / GMP, Country of In-house Specification Pack size of manufacturer issued FSC Import/ bottles 90ml, dated 10th March Manufacturer 120ml, 250ml, 2015. Vemedime 500ml, 1 L, 5 L WHO GMP Veterinary certificate issued Medicine Import valid till 03rd export joint stock September 2016. Company 07 April 30th St., Ninh Kieu District, Cantho City, Vietnam. 154. - Importer - C.R.D PLUS Veterinary oral Form 5-A Sole agency Deferred for the Al-Asar Powder Rs. 100,000/- agreement issued confirmation of Enterprises – vide Dy. No. dated 23-05-2011. me too status and House # 2574/A, Each 100gm contains 186 dated 16- GMP certificate approval status in Sarai Street, Lincomycin 16,700mg 04-2012 & Dy. of product issued reference Justice Hameed Spectinomycin 33,300mg No. 875 dated dated 23-09-2015 regulatory Colony, Nishtar Bromhexin 200mg 10-05-2013 valid for two years. authority and Road, Multan. GMP inspection original legalized Country of Antibiotics report of the CoPP / GMP, Import/ In-house Specification Pack size of manufacturer issued FSC Manufacturer bottles 50gm, dated 10th March Vemedime 100g, 200g, 2015. Veterinary 500g, 1kg, 5kg WHO GMP Medicine Import certificate issued export joint stock Available in valid till 03rd Company country of September 2016. 07 April 30th St., origin for free Ninh Kieu sale District, Cantho City, Vietnam.
Minutes for 257th Registration Board Meeting 64
155. - Importer - Amoxi 15% LA Veterinary Form 5-A Sole agency Deferred for the Al-Asar Liquid Injection Rs. 100,000/- agreement issued confirmation of Enterprises – vide Dy. No. dated 23-05-2011. me too status and House # 2574/A, Each 100ml contains 186 dated 16- GMP certificate approval status in Sarai Street, Amoxicillin Trihydrate 04-2012 & Dy. of product issued reference Justice Hameed 15000mg No. 875 dated dated 23-02-2016 regulatory Colony, Nishtar 10-05-2013 GMP inspection authority and Road, Multan. Antibiotics report of the original legalized In-house Specification manufacturer issued CoPP / GMP, Country of Pack size of dated 10th March FSC Import/ bottles 10ml, 2015. Manufacturer 20ml, 50ml, WHO GMP Vemedime 100ml certificate issued Veterinary valid till 03rd Medicine Import Amoxypen LA September 2016. export joint stock injection – Company MSD Animal 07 April 30th St., Health-UK Ninh Kieu District, Cantho City, Vietnam. Amovet LA injection (Nawan Labs Karachi 156. - Importer - Colinorcin Veterinary Form 5-A Sole agency Deferred for the Al-Asar Injection Rs. 100,000/- agreement issued confirmation of Enterprises – vide Dy. No. dated 23-05-2011. me too status and House # 2574/A, Each 1000 ml contains 185 dated 16- GMP certificate approval status in Sarai Street, Colistin Sulfate 25,000,000 04-2012 & Dy. of product issued reference Justice Hameed IU No. 875 dated dated 23-09-2014 regulatory Colony, Nishtar Lincomycin HCl 10,000mg 10-05-2013 valid for two years. authority and Road, Multan. GMP inspection original legalized Antibacterial report of the CoPP / GMP, Country of In-house Specification Pack size of manufacturer issued FSC Import/ bottles 10ml, dated 10th March Manufacturer 20ml, 50ml, 2015. Vemedime 100ml WHO GMP Veterinary certificate issued Medicine Import Jordan, valid till 03rd export joint stock Malaysia, September 2016. Company Taiwan, KSA 07 April 30th St., Ninh Kieu District, Cantho City, Vietnam. 157. - Importer - Ketovet 100 Veterinary Form 5-A Sole agency Deferred for the Al-Asar Injection Rs. 100,000/- agreement issued confirmation of Enterprises – vide Dy. No. dated 23-05-2011. me too status and House # 2574/A, Each ml contains 187 dated 16- GMP certificate approval status in Sarai Street, Ketoprofen 100mg 04-2012 & Dy. of product issued reference Justice Hameed No. 875 dated dated 23-07-2015 regulatory Minutes for 257th Registration Board Meeting 65
Colony, Nishtar Route of Administration IM 10-05-2013 valid for two years. authority and Road, Multan. GMP inspection original legalized NSAID report of the CoPP / GMP, Country of In-house Specification Pack size of manufacturer issued FSC Import/ bottles 10ml, dated 10th March Manufacturer 20ml, 50ml, 2015. Vemedime 100ml WHO GMP Veterinary certificate issued Medicine Import Anafen valid till 03rd export joint stock Injection- September 2016. Company Canada 07 April 30th St., Ninh Kieu Ketoject- District, Cantho Selmore City, Vietnam. 158. - Importer - Vime-Anticoc Veterinary Form 5-A Sole agency Deferred for the Al-Asar oral powder Rs. 100,000/- agreement issued confirmation of Enterprises – vide Dy. No. dated 23-05-2011. me too status and House # 2574/A, Each 1000gm contains 187 dated 16- GMP certificate approval status in Sarai Street, Sulfadimidin sodium 04-2012 & Dy. of product issued reference Justice Hameed 240000mg No. 875 dated dated 12-06-2014 regulatory Colony, Nishtar Diaveridine HCl 24000mg 10-05-2013 valid for two years. authority and Road, Multan. Menadione Na Bisulfate GMP inspection original legalized (K3) 500 mg report of the CoPP / GMP, Country of Vitamin B1 500 mg Pack size of manufacturer issued FSC Import/ Vitamin B6 500mg bottles 100gm, dated 10th March Manufacturer Sulfachloprpyrazine sodium 200gm, 500gm, 2015. Vemedime 100000mg 1kg, 5kg WHO GMP Veterinary certificate issued Medicine Import Antibacterial / Antimicrobial Registered in valid till 03rd export joint stock / Vitamins Vietnam September 2016. Company In-house Specification 07 April 30th St., Ninh Kieu District, Cantho City, Vietnam.
159. - Importer - Ceptifi Veterinary Injectable Form 5-A Sole agency Deferred for the Al-Asar suspension Rs. 100,000/- agreement issued confirmation of Enterprises – vide Dy. No. dated 23-05-2011. me too status and House # 2574/A, Each 100ml contains 183 dated 16- GMP certificate approval status in Sarai Street, Ceftiofur HCl eq to Ceftiofur 04-2012 & Dy. of product issued reference Justice Hameed 5000mg No. 875 dated dated 28-04-2014 regulatory Colony, Nishtar 10-05-2013 valid for two years. authority and Road, Multan. Route of Administration IM GMP inspection original legalized & subcutaneous report of the CoPP / GMP, Country of Pack size of manufacturer issued FSC Import/ Cephalosporin bottles 10ml, dated 10th March Manufacturer In-house Specification 20ml, 50ml, 2015. Minutes for 257th Registration Board Meeting 66
Vemedime 100ml WHO GMP Veterinary certificate issued Medicine Import FDA approved valid till 03rd export joint stock Excenel RTU September 2016. Company (Pfizer) 07 April 30th St., Ninh Kieu Cefur – RTU District, Cantho (Nawan) City, Vietnam.
160. - Importer - Vime-Cicep Veterinary oral Form 5-A Sole agency Deferred for the Al-Asar powder Rs. 100,000/- agreement issued confirmation of Enterprises – vide Dy. No. dated 23-05-2011. me too status and House # 2574/A, Each 1000gm contains 190 dated 16- GMP certificate approval status in Sarai Street, Oxytetracycline 100000mg 04-2012 & Dy. of product issued reference Justice Hameed Cephalexin 60000mg No. 875 dated dated 11-11-2015 regulatory Colony, Nishtar 10-05-2013 valid for two years. authority and Road, Multan. Antibiotics GMP inspection original legalized In-house Specification report of the CoPP / GMP, Country of Pack size of manufacturer issued FSC Import/ bottles 100gm, dated 10th March Manufacturer 200gm, 500gm, 2015. Vemedime 1kg, 5kg WHO GMP Veterinary certificate issued Medicine Import Registered in valid till 03rd export joint stock Vietnam, Spain September 2016. Company 07 April 30th St., Ninh Kieu District, Cantho City, Vietnam. 161. - Importer - Vime-Blue Veterinary Form 5-A Sole agency Deferred for the Al-Asar external spray Rs. 100,000/- agreement issued confirmation of Enterprises – vide Dy. No. dated 23-05-2011. me too status and House # 2574/A, Each 100ml contains 191 dated 16- GMP certificate approval status in Sarai Street, Blue Methylene 1000mg 04-2012 & Dy. of product issued reference Justice Hameed Oxytetracycline 500mg No. 875 dated dated 13-07-2015 regulatory Colony, Nishtar 1,5- pentanedial 200mg 10-05-2013 valid for two years. authority and Road, Multan. GMP inspection original legalized Antiseptics report of the CoPP / GMP, Country of In-house Specification Pack size of manufacturer issued FSC Import/ bottles 100ml, dated 10th March Manufacturer 200ml, 220ml 2015. Vemedime WHO GMP Veterinary Vime-Blue (S certificate issued Medicine Import & E valid till 03rd export joint stock Agriventures, September 2016. Company Phillipines) 07 April 30th St., Ninh Kieu Minutes for 257th Registration Board Meeting 67
District, Cantho City, Vietnam.
162. - Importer - Aminovit Veterinary Form 5-A Sole agency Deferred for the Al-Asar Injectable solution Rs. 100,000/- agreement issued confirmation of Enterprises – vide Dy. No. dated 23-05-2011. me too status and House # 2574/A, Each 100ml contains 191 dated 16- GMP inspection approval status in Sarai Street, Thiamin HCl 10mg 04-2012 & Dy. report of the reference Justice Hameed Riboflavin 4mg No. 875 dated manufacturer issued regulatory Colony, Nishtar D-Penthenol 5mg 10-05-2013 dated 10th March authority and Road, Multan. Nicotinamide 150mg 2015. original legalized L-Leucine 187mg WHO GMP CoPP / GMP, Country of L-Lysine 170mg Pack size of certificate issued FSC Import/ L-Glutamic acid 136mg bottles 10ml, valid till 03rd Manufacturer L-Valine 136mg 20ml, 50ml & September 2016. Vemedime L-Phenylamine 119mg 100ml free sale Veterinary L-Isoleucine 85mg certificate in Medicine Import L-Methionine 150mg Registered in country of origin export joint stock L-Tryptophan 34mg Vietnam. dated 29-05-2015. Company Calcium 150mg 07 April 30th St., Ninh Kieu Supplement District, Cantho In-house Specification City, Vietnam. 163. - Importer - Tulavitryl Veterinary Form 5-A Sole agency Deferred for the Al-Asar Injection Rs. 100,000/- agreement issued confirmation of Enterprises – vide Dy. No. dated 23-05-2011. me too status and House # 2574/A, Each 100ml contains 1013 dated 03- GMP certificate approval status in Sarai Street, Tulathromycin 10,000mg 09-2012 & Dy. of product issued reference Justice Hameed No. 875 dated dated 24-11-2015 regulatory Colony, Nishtar Route of Administration IM 10-05-2013 valid for two years. authority and Road, Multan. or Subcutaneous GMP inspection original legalized report of the CoPP / GMP, Country of Antiseptics Pack size of manufacturer issued FSC Import/ In-house Specification bottles 100ml, dated 10th March Manufacturer 200ml, 220ml 2015. Vemedime WHO GMP Veterinary FDA approved certificate issued Medicine Import Draxxin-Pfizer valid till 03rd export joint stock September 2016. Company 07 April 30th St., (Tulat-Hilton Ninh Kieu Vet) District, Cantho City, Vietnam.
Minutes for 257th Registration Board Meeting 68
164. - Importer – IVOMEC SUPER Injection Form 5-A Sole agency Deferred for the M/s Saadat Rs. 100,000/- agreement issued submission of International, 117 Each ml contains vide Dy. No. dated 23-03-2010. original legalized Habitat Flat, Ivermectin 10mg 206 dated 18- GMP certificate CoPP / GMP, Shadman II, Jail Clorsulon 100mg 04-2012 & Dy. of product issued FSC Road, Lahore Country of Import/ No. 694 dated dated 23-07-2015 Manufacturer Route of Administration 14-06-2013 valid for two years. MERIAL SAUDE subcutaneous injection GMP inspection ANIMAL LTD, report of the located in Fazenda Antibiotics Pack size of manufacturer issued Sao Francisco, In-house Specification bottles 50ml, dated 10th March Paulinia, Sao 200ml, 500ml 2015. Paulo, Brazil & 1000ml Ivomec-Plus- Merial-Brazil (FDA approved vide NADA140- 833)
G-Tek Plus (International Pharma)
Deferred Import Cases:-
S/N Name and Brand Name Type of Deferred in Remarks / Decision address of (Proprietary name + Form meeting of RB Observations manufactur Dosage Form + Initial date, due to following er / Strength) diary shortcomings Applicant Composition Fee Pharmacological including Group differential Finished product fee Specification Demanded Price / Pack size
Internation al status in stringent regulatory agencies
Me-too status
GMP status
Minutes for 257th Registration Board Meeting 69
as depicted in inspection report (dated) 165. - Importer - Oxytetravet IM Form 5-A Deferred in 256th All Deferred for M/s Samara Veterinary Injection Rs. RB meeting for shortcomings the submission Stores. 16- 20% 100,000/- Sole agency rectified. of original 17, Qamar vide Dy. agreement. GMP legalized Market, Each 1 ml contains No. 156 certificate of CoPP / GMP, Latifabad Oxytetracycline (as dated 02-03- GMP manufacturer FSC No. 7, HCl) 200mg 2011 & Dy. certificate of issued by Hyderabad. No. 2292 product. Ministry of Country of Antibiotics dated 23-12- GMP Agriculture / Import/ In-house 2013 inspection Veterinary Manufacture Specification report of the Dept., r manufacturer Pharmacy & The Arab Pack size of required. Drug control Pesticides & 50ml Division, Veterinary &100ml Jordan dated Drugs Mfg. amber glass 22-1-2015. Co bottle GMP (Mobedco) 1.5$ certificate P.O Box dated 31-01- 930103 Oxytetracyc 2016. Amman line Sole agency 11193 Injection agreement Jordan. 20% - submitted. Norbook - Ireland
Engemycin LA 200mg/ml (MSD-UK)
Oxytetracyc line Injection 20% (Star Laboratories ) Lahore
Minutes for 257th Registration Board Meeting 70
166. - Importer - Betamoxin Veterinary Form 5-A Deferred in 256th All Deferred for M/s Samara Injection Rs. RB meeting for shortcomings the submission Stores. 16- 100,000/- Sole agency rectified. of original 17, Qamar Each 1 ml contains vide Dy. agreement. GMP legalized Market, Amoxicillin (as No. 157 CoPP / GMP, GMP certificate of Latifabad Trihydrate) 150mg dated 02-03- manufacturer FSC No. 7, 2011 & Dy. certificate of product. issued by Hyderabad. Antibiotics No. 2292 Ministry of In-house dated 23-12- GMP Agriculture / Country of Specification 2013 inspection Veterinary Import/ report of the Dept., Manufacture manufacturer Pharmacy & r Pack size of required. Drug control The Arab 50ml, 100ml Division, Pesticides & amber glass Jordan dated Veterinary bottle 22-1-2015. Drugs Mfg. 1.5$ GMP Co certificate (Mobedco) Amoxypen dated 31-01- P.O Box Injection – 2016. 930103 MSD UK Sole agency Amman agreement 11193 submitted. Jordan. Amovet (Nawan) 167. Importer Lokcid 40mg Form 5-A Deferred in 236th All Approved M/s AJM injection of Rs. meeting of RB for shortcomings Pharma Lyophilized Powder 100,000/- Legalized GMP rectified. (Pvt.) Ltd, certificate Legalized Shafi Court, Rs. 15000/- Each vial contains:- Certificat first floor, vide Dy. Omeprazole sodium Merewether No. 607 e of good Road, Civil 42.6mg eq to dated 13-06- manufact Lines,Karach Omeprazole 40mg 2012 uring i practices ( Proton Pump Rs. 85000/- issued on Country of Inhibitor) vide Dy. 22-02- Import/ No. 2292 2012whic Manufacture dated 23-12- h is valid r 2013 until 21- M/s Furen 02-2017 Pharmaceuti by State cal Group Pack size Co. L td, 1’s Rs. food & Xuan Wu 300/- Drug Economic Administr developing MHRA ation, area LuYi approved China. County, Losec Henan Province. Risek-Getz
Minutes for 257th Registration Board Meeting 71
China
M/S EPHARM LABORATORIES, A-40, ROAD NO. 1, S.I.T.E, SUPER HIGHWAY, KARACHI S/N Name and Brand Name Type of Form International status Decision address of (Proprietary name + Initial date, diary in stringent manufacturer / Dosage Form + Strength) Fee including regulatory agencies Applicant Composition differential fee Pharmacological Group Demanded Price Me-too status Finished product / Pack size Specification GMP status as depicted in inspection report (dated)
Four products mentioned below, of M/s Epharm Laboratories,Karachi were Deferred in 242nd meeting of RB for Product Specific Inspection by Director DTL Karachi, DDG DRAP and area FID Rectification of below mentioned deficiencies in Form 5: USP specifications have been claimed for the finished product however, the actual specifications provided are not according to USP. Complete packaging material specifications are required. Vial has been mentioned in form 5 while ampoule in finished product specifications.
Now firm has submitted reply w.r.t above mentioned shortcomings wherein they also submitted product specific inspection report with recommendations as under:- “Based on the areas inspected, the people met and the documents reviewed and considering the findings of the inspection including the corrective and preventive action taken and planned, and adequate production, quality control and storage facilities at the site, panel recommends the registration of the products covered in DRAP letter No. F.3-1/2014-Reg-II (M-242) dated 29th January 2016.”
168. M/s Epharm Injection AMIKACIN 500 Form-5 MHRA approved a Approved Laboratories, mg Fast Track product of A-40, Road No. 23/10/2013, Dy. # Hospira,UK 1, S.I.T.E, Each 2ml vial contains:- 261 R&I dated Super Highway, Amikacin (as Sulphate) 23/10/2013 Grasil-Sami 500mg (Rs. 60,000/-) Karachi
Antibiotics Pack size of USP specification Rs.200 per 1x2ml
Minutes for 257th Registration Board Meeting 72
169. -do- Injection AMIKACIN 250 Form-5 Deferred mg Fast Track Grasil-Sami for 23/10/2013, Dy# confirmati Each 2ml vial contains:- 264 R&I dated on of Amikacin (as Sulphate) 23/10/2013 approval 250mg (Rs. 60,000/-) status of dosage Antibiotics Pack size of form USP specification Rs.150 per 1x2ml (250mg per 2ml) in same strength in reference regulatory authorities .
170. -do- Injection AMIKACIN 100 Form-5 MHRA approved a Approved mg Fast Track product of Dy. # 260 R&I Hospira,UK Each 2ml vial contains:- 23/10/2013 Amikacin (as Sulphate) (Rs. 60,000/-) Grasil-Sami 100mg Pack size of Antibiotics Rs.90 per 1x2ml USP specification
171. -do- Vitamin B1, B6, B12 Form-5 Neurobion- Merck Approved Injection Fast Track Greece Dy. # 259 R&I Each 3ml of aqueous dated 23/10/2013 Neurobion-Merck solution per ampoule (Rs. 60,000/-)
contains:- Pack size Rs.150 per Thiamine HCl B.P 25x3ml (Vitamin B1) ….. 100mg
Pyridoxine HCl B. P (Vitamin B6).. 100mg
Cyanocobalamine B.P (Vitamin B12)1000mcg
Vitamins Manufacture Specification
Minutes for 257th Registration Board Meeting 73
M/s ELITE PHARMA (PVT.) LTD, 9.5 km, SHEIKHUPURA ROAD, P.D.H STREET, LAHORE.
Registration Board in its 254th meeting held on held on 11-12th November 2015 approved Amikacin 500mg/2ml injection. Inadvertently, this decision was missed in recording of the minutes of the said meeting at Sr. # 104 and the box remains blank.
S/N Name and Brand Name Type of Form International Decision address of (Proprietary name + Dosage Initial date, status in stringent manufacturer Form + Strength) diary regulatory / Applicant Composition Fee including agencies Pharmacological Group differential Finished product fee Me-too status Specification Demanded Price / Pack GMP status as size depicted in inspection report (dated)
172. M/s Elite Elikacin Injection 500 mg Form 5 MHRA approved Approved Pharma Rs. 20,000/- Amikacin (Pvt.) Ltd, Each 2 mlVial contains Vide Dy. No. 500mg/ml Lahore Amikacin (as Sulphate) …. 877 dated (Hospira.UK) 500 mg 25-06-2011 and dated 25- Grasil 500 MG / Aminoglycosides (Antibiotic) 11-2013 2ML (SAMI)
(BP Specification) Pack of 2 ml GMP compliant / Rs. 160 sections for Liquid Injection Ampoule (General) as per inspection report dated 11-09-2014.
M/s ELITE PHARMA (PVT.) LTD, 9.5 km, SHEIKHUPURA ROAD, P.D.H STREET, LAHORE.
Registration Board in its 254th meeting held on 11-12th November 2015 deferred the case of firm for registration of injection amikacin 250mg/2ml for provision of approval status of same dosage form in same strength in reference regulatory authorities recommended by RB. Now firm has submitted reply with respect to minutes of 254th meeting of RB wherein they provided following international availability of dosage form.
Minutes for 257th Registration Board Meeting 74
173. Brand Name:- Amikacin Brand Name:- Likacin 250 Active Ingredient:- Amikacin Sulphate Active Ingredient:- Amikacin Sulphate 250mg/2ml 250mg/2ml Company name & Address:- Company name & Address:- ILDONG PHARMA AVERSI PHARMA (137-733)2, Baumoe-ro 27-gil, Seocho- 27b vazha-phsave str, Tblisi. gu, Seoul, Korea.
The above mentioned international availabilities provided by the firm are not the reference regulatory authorities recommended by RB. Decision: Registration Board deferred the case for confirmation of same formulation in reference regulatory authorities.
Evaluator I. Muhammad Ansar
S. Name and Brand Name Type of Form Remarks on the Decision No address of (Proprietary name + formulation (if manufacturer Dosage Form + Initial date, diary any) including / Applicant Strength) International Fee including status in stringent Composition differential fee drug regulatory agencies / Pharmacological Group Demanded Price authorities / Pack size Finished product Me-too status Specification GMP status as depicted in latest inspection report (with date) by the Evaluator
174 M/s Febo 40mg Tablet Form-5 FDA. Uloric Approved Paramount 40mg film coated Pharmaceutic Each film coated tablet 17-07-2012 vide tablet by M/s als, Kahuta contains:- diary No. 7142 Takeda. Road, Febuxostat…….40mg (R&I) Rs.8,000 Islamabad. & 22-07-2013 Local. Zurig Xanthine Oxidase vide diary No. 40mg tablet by (1788) Inhibitor. 4578 Rs.12,000 M/s Getz
Manufacturer’s Rs.330/20’s The firm is Specifications Overall GMP compliance as per inspection dated
Minutes for 257th Registration Board Meeting 75
05-01-2016 by area FID
175 -do- Febo 80mg Tablet Form-5 MHRA. Adenuric Approved 80mg film coated (1789) Each film coated tablet 17-07-2012 vide tablet by M/s A. contains:- diary No. 7142 Menarini. Febuxostat…….80mg (R&I) Rs.8,000 & 22-07-2013 Local. Zurig Xanthine Oxidase vide diary No. 80mg tablet by Inhibitor. 4578 Rs.12,000 M/s Getz The firm is Manufacturer’s Rs.58520’s Overall GMP Specifications compliance as per inspection dated 05-01-2016 by area FID
176 -do- Citona 500mg Tablet Form-5 Rejected as the Each tablet contains:- 29-11-2012 vide formulation (2013) Citicoline diary No. 10048 is not Sodium…….500mg (R&I) Rs.20,000. approved by reference Rs.655/10’s drug regulatory Nootropics. agencies
Manufacturer’s Specifications 177 M/s Zafa Piperataz Injection 4.5g Form-5 Tazocin Approved Pharmaceutic Injection al 10-06-2011 vide Laboratories, Each vial contains:- diary No. 98 Local. Tanzo (PVT) Ltd, Piperacillin Sodium eq (R&I) Rs.8,000. 4.5gm injection Karachi. to Piperacillin…..4gm & 01-08-2013 by M/s Bosch vide diary No. (1129) Tazobactam Sodium eq 602 Rs.12,000. Firm is operating to at acceptable Tazobactam…….0.5gm As per SRO. level of GMP compliance as per inspection dated 20-01-2016. Penicillin.
Minutes for 257th Registration Board Meeting 76
Manufacturer’s Specifications 178 -do- Zampi-Sul Injection Form-5 Local. Sulbarax Deferred for 750mg Injection 750mg injection the 14-03-2011 vide by M/s confirmation (919) Each vial contains:- diary No. 187 Mediceena of approval Ampicillin Sodium eq to (R&I) Rs.8,000. status of same Ampicillin …..500mg & 01-08-2013 Firm is operating formulation vide diary No. at acceptable Salbactam Sodium eq to in reference 606 Rs.12,000. level of GMP drug Salbactam …….250mg compliance as per authorities. As per SRO. inspection dated 20-01-2016 Penicillin.
USP Specifications 179 M/s Otsuka AceRing Infusion Form-5 FDA. Acetated Deferred. Pakistan Ltd, ringer in Plastic Firm shall F/4-9, Hub Each 1000ml contains:- 17-01-2012 vide container CaCl2. apply on Industrial diary No. 42 20mg, KCl. prescribed Trading Sodium Acetate (R&I) 30mg, Sodium Form 5-D and requisite Estate, Trihydrate…..3.8gm Rs.8,000.&16- Acetate.380mg, documents. Lasbella, 08-2013 vide NaCl.600mg/100 Balochistan. Potassium diary No. 1220 ml Chloride……0.3gm Rs.12,000. Overall GMP Calcium Chloride 2H2O (1475) Rs.271.05/1000 compliance level ……0.2gm ml. was found Sodium compliant as Chloride…..6.0gm concluded by area FID vide Physiological electrolyte inspection dated. solution 03-02-2016
Manufacturer’s Specifications 180 -do- Pladex-25 Infusion Form-5 FDA. Dextrose Approved 25% by M/s Each 1000ml contains:- 13-08-2012 vide Hospira. (1837) diary No. 1427 Dextrose (R&I) Rs.8,000. Local. Medisol Anhydrous……….250g 28-11-2013 vide 25% by M/s m dy No. 235 R&I Medipak. Rs.12,000. (Carbohydrate) Overall GMP
Minutes for 257th Registration Board Meeting 77
compliance level Manufacturer’s Rs.75/1000ml. was found Specifications compliant as concluded by area FID vide inspection dated. 03-02-2016 181 -do- Sterile Water for Form-5 Approved. injection 5ml Registration 17-01-2012 vide Overall GMP Board (2692) Each ampoule contains:- diary No. 42 compliance level authorized its Sterile water for (R&I) Rs.8,000 was found chairman for Issuance of injection…….5ml (Photocopy). & compliant as registration 16-08-2013 vide concluded by area WFI letter after diary No. 1219 FID vide confirmation Rs.12,000. inspection dated. USP Specifications of fee challan 03-02-2016 of Rs.8000 Rs.9/5ml. from Budget & Accounts section of DRAP. 182 M/s Rasco Rostin-10 Tablet Form-5 MHRA. Crestor Approved Pharma, film coated Raiwind Each tablet contains:- 29-06-2012 vide tablets 5,10,20 & Road, diary No. 5870 40mg by M/s Lahore. Rosuvastatin as (R&I) Rs.8,000 AstraZeneca Calcium…..10mg & Rs.12000 (1779) dated. 30-07- Local. Rosuva 5, Antihyperlipidemic 2013 10, 20mg tablet by m/s Wilsons USP Specifications As per SRO. Firm is GMP compliant as per inspection dated 09-09-2015 by the panel.
183 Rostin-20 Tablet Form-5 MHRA. Crestor Approved film coated Each tablet contains:- 29-06-2012 vide tablets 5,10,20 & diary No. 5862 40mg by M/s (1780) Rosuvastatin as (R&I) Rs.8,000 AstraZeneca Calcium…..20mg & 30-07-2013 Local. Rosuva 5, Antihyperlipidemic As per SRO. 10, 20mg tablet by m/s Wilsons Minutes for 257th Registration Board Meeting 78
USP Specifications Firm is GMP compliant as per inspection dated 09-09-2015 by the panel.
184 M/s Rasco Tablet Pioglimp 15 mg Form 5 with fee Deferred for Pharma, 8000/- Dy. No. the Each tablet contains confirmation Lahore Pioglitazone (as HCl) 15mg 2914 dated 27- Zoliget (Getz) (1783) 2012 06-2011 and fee of approval Glimipride 2 mg status in 12000/- Dy. No. reference Anti-Diabetic 598 dated 16-01- drug (1783) 2014 authorities. Manufacturer’s Specification. As per SRO 185 -do- Rostin-5 Tablet Form-5 MHRA. Crestor Approved film coated Each tablet contains:- 29-06-2012 vide tablets 5,10,20 & diary No. 5873 40mg by M/s Rosuvastatin as (R&I) Rs.8,000 AstraZeneca (1778) Calcium…..5mg & 12000 dated 30-07-2013 Local. Rosuva 5, Antihyperlipidemic 10, 20mg tablet As per SRO. by m/s Wilsons USP Specifications
Firm is GMP compliant as per inspection dated 09-09-2015 by the panel.
186 -do- Pioglimp-30 Tablet Form-5 FDA. Duetact Approved tablets 2mg/30mg Each tablet contains:- 29-06-2012 vide by M/s Takeda diary No. 5870 Pioglitazone…..30mg (R&I) Rs.8,000 Local. Piotone (1782) Glimepiride…..2mg & 12000 dated Gem 30/2mg, 30-07-2013 30/4mg by M/s Antidiabetic Atco As per SRO. Manufacturer’s Firm is GMP Specifications compliant as per
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inspection dated 09-09-2015 by the panel.
187 -do- Sitagliptin DS Tablet Form-5 MHRA. Janumet Approved 50/100mg film Each film coated tablet 29-06-2012 vide coated tablets by contains:- diary No. 5872 M/s Merck Sharp (R&I) Rs.8,000 & Dohme Ltd Sitagliptin as Phosphate & Rs.12000 Monohydrate…..50mg dated 30-07- Local. Janumet (1781) 2013. 50/1000 by M/s Metformin Wilshire. HCl…..1000mg As per SRO. Firm is GMP Antidiabetic compliant as per Manufacturer’s inspection dated Specifications 09-09-2015 by the panel.
188 M/s OBS Sleepill 2mg Tablet Form-5 FDA. Lunesta 1, Approved Pakistan 2, & 3mg film with change (Pvt) Ltd, C- Each film coated tablet 03-06-2013 vide coated tablets by of brand 14, S.I.T.E., contains:- diary No. 1160 M/s Sunovion name Manghopir Eszopiclone…..…..2mg (R&I) Rs.20,000 road, Local Clonexa 1, Karachi. Hypnotic agent Rs.14.12/tablet 2, 3mg tablets by M/s Atco. Manufacturer’s Panel vide (2087) Specifications. inspection dated 08-04-2015 recommended the renewal of license.
189 -do- Bosecard Tablet 125mg Form-5 MHRA. Tracleer Approved 125mg f/c tablet Each film coated tablet 01-10-2013 vide by M/s Actelion. contains:-Bosentan diary No. 169 Monohydrate eq to (R&I) Rs.20,000 Local. Bosmon (2088) Bosentan …..….125mg 125mg by M/s Rs.270.59/Pack Hilton Endothelial Receptor Reg.066964 Antagonist Minutes for 257th Registration Board Meeting 80
Manufacturer’s Panel vide Specification. inspection dated 08-04-2015 recommended the renewal of license.
190 M/s Medipak Medigyl 200mg tablet Form-5 MHRA. Flagyl Approved Ltd, Lahore. 200mg tablet film Each film coated tablet 06-06-2012 vide coated by M/s contains:- diary No. 4094 Zentiva Metronidazole.…….200 (R&I) Rs.8,000 (1670) mg & 23-08-2013 Flagyl 200mg vide diary No. Sanofi Aventis Antibacterial 1109 Rs.12000. The panel vide B.P Specifications Rs.250/as per the inspection dated price of brand 26-03-2015 leader. recommended the renewal of DML.
191 -do- Medigyl 400mg tablet Form-5 MHRA. Flagyl Approved 400mg tablet film Each film coated tablet 06-06-2012 vide coated by M/s contains:- diary No. 4082 Zentiva Metronidazole.…….400 (R&I) Rs.8,000 (1674) mg & 23-08-2013 Flagyl 400mg vide diary No. Sanofi Aventis Antibacterial 1109 Rs.12000. The panel vide B.P Specifications Rs.450/as per the inspection dated price of brand 26-03-2015 leader. recommended the renewal of DML.
192 M/s Prix Gesic Fort WSP Form-5 Approved Pharmaceutic Vitamin C by M/s a (Pvt) Ltd. Each 1gm contains:- 07-09-2012 vide VMD Plot # 5 Acetylsalicylic diary No. 107 Pharmacity, acid.…….100mg (R&I) Rs.8,000 The firm is GMP 30-Km & 21-08-2013 compliant as per Multan Road, NSAID vide diary 1079 inspection dated Lahore. Rs.12,000 03-05- 2015. Manufacturer’s
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Specifications. Decontrolled/100 (293) gm, 1000gm, 5Kg
193 -do- Pri-Cyanofos Injection Form-5 Approved Tonovit Injection Each ml contains:- 22-10-2012, by M/s Selmore Toldimphos Rs.8,000 & 22- Pharma Sodium.…….200mg 10-2012 (315) Rs.12,000 vide The firm is GMP Cyanocobalamin(Vit diary No. 1136 compliant as per B12)……0.05mg dated 01-11- inspection dated 2012 (R&I) 03-05- 2015. Mineral/vitamin Decontrolled/50 Manufacturer’s ml Specification 194 -do- Pri-Thiamcol Injection Form-5 The firm is GMP Deferred for compliant as per confirmation Each ml contains:- 22-10-2012, inspection dated of me too Thiamphenicol.…….250 Rs.8,000 & 22- 03-05- 2015. status mg 10-2012 (309) Rs.12,000 vide Thiamphenicol diary No. 1124 Derivatives dated 01-11- 2012 (R&I) Manufacturer’s Specifications Decontrolled/ 50ml,
195 -do- Pri-Florcid Injection Form-5 Approved Florofen Injection Each ml contains:- 22-10-2012, 300mg/ml by M/s Florfenicol.……….300 Rs.8,000 & 22- Leads Pharma (302) mg 10-2012 Rs.12,000 vide The firm is GMP Antibacterial. diary No. 1131 compliant as per dated 01-11- inspection dated Manufacturer’s 2012 (R&I) 03-05- 2015. Specifications. Decontrolled/50 ml
196 -do- Pri-Macrocin Injection Form-5 Approved Lincotin Injection Each ml contains:- 22-10-2012, by M/s Star
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Lincomycin as HCl eq to Rs.8,000 & 22- Laboratories. Lincomycin.…….50mg 10-2012 Rs.12,000 vide The firm is GMP Spectinomycin as HCl diary No. 1133 compliant as per (300) eq to dated 01-11- inspection dated Spectinpmycin…….100 2012 (R&I) 03-05- 2015. mg Decontrolled/100 Antibiotic ml Manufacturer’s Specifications 197 -do- Pri-Osteovit Injection Form-5 Approved Vitamin ADE Each ml injection 07-09-2012 vide Injection by M/s contains:- Vitamin diary No. 617 Alina Pharma A.…….80,000IU (R&I) Rs.8,000 & 21-08-2013 The firm is GMP (299) Vitamin vide diary 1093 compliant as per D3……….40,000IU Rs.12,000 inspection dated 03-05- 2015. Vitamin E Decontrolled/50 (Acetate)……..20mg ml
Vitamin
Manufacturer’s Specification 198 -do- Trocid 34 Injection Form-5 Approved Nitronil 34% Each ml injection 07-09-2012 vide Injection by M/s contains:- diary No. 616 Manhattan Nitroxynil.…….340mg (R&I) Rs.8,000 Pharma & 21-08-2013 (298) Flukcidal/wormicidal vide diary 1089 The firm is GMP Rs.12,000 compliant as per Manufacturer’s inspection dated Specifications Decontrolled/50 03-05- 2015. ml
199 -do- Ketoflame 10 Injection Form-5 Approved Ketoject 10% Each ml injection 17-02-2012 vide Injection by M/s contains:- diary No. 107 selmore Pharma Ketoprofen.…….100mg (R&I) Rs.8,000 & 31-07-2013 The firm is GMP (223) NSAID vide diary 981 compliant as per
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Rs.12,000 inspection dated Manufacturer’s 03-05- 2015. Specifications Decontrolled/50 ml
200 -do- Pri-Phen 20 Injection Form-5 Deferred for Elkazolidine expert Each ml injection 17-02-2012 vide Injection by M/s opinion for contains:- diary No. 118 Elko Pharma the use Phenylbutazone.…….20 (R&I) Rs.8,000 formulatin of following 0mg & 31-07-2013 The firm is GMP vide diary 979 veterinary (216) compliant as per experts:- NSAID Rs.12,000 inspection dated Dr. 03-05- 2015. Shoaib Manufacturer’s Decontrolled/50 Specifications Akhtar, ml Professo r of Pharmac ology, Faculty of Pharmac y, Universi ty of Sargodh a. Brig (R). Dr. Muzam mil Hasan Najmi, Associat e Dean, Basic Sciences Division , Foundati on Universi ty Medical College, Rawalpi ndi Dr.Ashr af
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UVAS 201 -do- Pri-Colis 0.2 Injection Form-5 Approved Colisan Injection Each ml injection 17-02-2012 vide by M/s Nawan contains:- Colistin diary No. 111 Pharma Sulphate eq to (R&I) Rs.8,000 Colistin.…….0.2MIU & 21-08-2013 The firm is GMP (220) vide diary 1090 compliant as per Antibiotic Rs.12,000 inspection dated 03-05- 2015. Manufacturer’s Decontrolled/50 Specifications ml
202 -do- Cotrim 48 Injection Form-5 Approved Tribactral Each ml injection 17-02-2012 vide Injection by M/s contains:- diary No. 113 Selmore Pharma Trimethoprim.…….80m (R&I) Rs.8,000 g & 31-07-2013 The firm is GMP vide diary 980 compliant as per Sulphadiazine…….400 Rs.12,000 inspection dated (222) mg 03-05- 2015. Decontrolled/50 Sulphonamide/antibiotic ml
Manufacturer’s Specifications 203 -do- Primisole 15 Injection Form-5 Approved Levacon By M/s Each ml injection 22-08-2012 Vetcon contains:- Levamisol as Rs.8,000 & 22- HCl.……...150mg 08-2012 The firm is GMP Rs.12,000 vide compliant as per Imidazothiazole diary 1121 dated inspection dated (313) 01-11-2012. 03-05- 2015. USP Specifications Decontrolled/50 ml,
204 -do- Pri-Anased Injection Form-5 Approved Acemav Injection Each ml injection 17-02-2012 vide by M/s Mustafa contains:- Acepromazine diary No. 100 Brothers as Maleate.…….10mg (R&I) Rs.8,000 & 21-08-2013 The firm is GMP (217) Phenothiazine vide diary 1081 compliant as per Rs.12,000 inspection dated USP Specifications
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03-05- 2015. Decontrolled/50 ml
205 -do- Pri-Progest Injection Form-5 Deferred for Pregtone the Each ml injection 22-10-2012 vide Injection by M/s confirmation contains:- Rs.8,000 & 22- Selmore Pharma of dedicated Progesterone.…….25mg 10-2012 manufacturin g facility (312) Rs.12,000 vide The firm is GMP Hormone diary 1119 from compliant as per Licensing inspection dated Division, USP Specifications Decontrolled/10 03-05- 2015. DRAP ml,
206 -do- Oxyflame LA Injection Form-5 Approved OTC forte Each ml injection 22-10-2012 vide Injection by M/s contains:- Rs.8,000 & 22- Breeze Pharma Oxytetracycline 10-2012 Dihydrate.…….300mg Rs.12,000 vide The firm is GMP diary 1126 dated compliant as per Flunixin 1-11-2012 R&I inspection dated (307) Meglumine……20mg 03-05- 2015. Decontrolled/50 Antibiotic/NSAID ml
Manufacturer’s Specifications 207 -do- Pri-Closmec Injection Form-5 Approved Clomac Injection Each ml injection 22-10-2012 vide by M/s Symans contains:- Rs.8,000 & 22- Pharma Ivermectin.…….10mg 10-2012 Rs.12,000 vide The firm is GMP Closantel…….125mg diary 1125 R&I compliant as per (308) dated 1-11-2012 inspection dated Avertmectins/salicylanili 03-05- 2015. de Decontrolled/100 ml, Manufacturer’s Specifications. 208 -do- Pri-Flumexil 7.5% Form-5 Approved Injection Flumecon by M/s 22-10-2012 vide Vetcon Each ml injection Rs.8,000 & 22- contains:- 10-2012 The firm is GMP (304) Flumequine.…….75mg Rs.12,000 vide compliant as per
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diary 1129 R&I inspection dated Antibiotic dated 1-11-2012 03-05- 2015.
Manufacturer’s Decontrolled/ Specifications 50ml
209 -do- Pri-Buquone Injection Form-5 Approved Jftalex Injection Each ml injection 22-10-2012 vide by M/s Jafrin contains:- Rs.8,000 & 22- Pharma Buparvaquone.…….50 10-2012 mg Rs.12,000 vide The firm is GMP (317) diary 1134 R&I compliant as per Antiprotozoan dated 1-11-2012 inspection dated 03-05- 2015. Manufacturer’s Decontrolled/50 Specifications ml
210 -do- Aquapri Injection Form-5 The firm is GMP Deferred for compliant as per the Sterile Water for 22-10-2012 vide inspection dated clarification Injection Rs.8,000 & 22- 03-05- 2015. of intended 10-2012 use by the firm. (316) WFI Rs.12,000 vide diary 1135 R&I USP Specifications dated 1-11-2012
Decontrolled/100 ml vial
211 -do- Pri-EN 20 Injection Form-5 Approved Encure 20 Each ml injection 17-02-2012 vide Injection by M/s contains:- diary No.97 R&I Nawan Pharma Enrofloxacin.…….200m Rs.8,000 & 21- (212) g 08-2013 vide The firm is GMP diary No. 1086 compliant as per Antibiotic R&I Rs.12,000 inspection dated 03-05- 2015. Manufacturer’s Decontrolled/10 Specifications mlx5,
212 -do- Pri-Becovit Injection Form-5 Approved Multivitamin by Each ml injection 17-02-2012 vide M/s VMD contains:- Vitamin diary No.96 R&I A.…….50,000IU Rs.8,000 & 21- The firm is GMP
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08-2013 vide compliant as per Vitamin D3……25,000IU diary No. 1095 inspection dated (214) R&I Rs.12,000 03-05- 2015. Vitamin E (Acetate)……..4.0mg Decontrolled/20 mlx5, 50ml & Vitamin B1…….2.5mg 100ml
Vitamin B2 as Sodium Phosphate……2.0mg
Vitamin B6……..1.25mg
Vitamin B12………30ug
Vitamin C…….2.0mg
Nicotinamide……..12.5 mg
Dexpanthenol……..3.0 mg
Vitamins
Manufacturer’s Specifications 213 -do- Ectomec 10 Injection Form-5 Approved Dectomex Each ml injection 17-02-2012 vide Injection by M/s contains:- diary No.116 Ghazi Brother. Doramectin.…….10mg Rs.8,000 & 31- 07-2013 vide The firm is GMP (215) Avermectins diary No.978 compliant as per R&I Rs.12,000 inspection dated Manufacturer’s 03-05- 2015. Specifications Decontrolled/50 ml
214 -do- Pri-Choligen Injection Form-5 Deferred for Metagen Injection confirmation Each ml injection 17-02-2012 vide by M/s Breeze of contains:- Phenoxy-2- diary No.112 Pharma formulation methyl-2-Propionic Rs.8,000 & 21- acid.…….100mg 08-2013 The firm is GMP (221) Rs.12,000 vide compliant as per
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diary 1082 R&I inspection dated Choleretic dated 03-05- 2015.
Manufacturer’s Decontrolled/50 Specifications ml
215 -do- Pri-Adrine Injection Form-5 Deferred for approval Each ml injection 17-02-2012 vide status in contains:- diary No.101 The firm is GMP Pakistan and Adrenaline.…….1mg Rs.8,000 & 21- compliant as per clarification of intended (218) 08-2013 inspection dated Vasoconstrictor Rs.12,000 vide use. 03-05- 2015. The board diary 1087 R&I B.P Specifications has further referred the Decontrolled/30 case for the ml expert opinion by the veterinary expert:- Dr.Muhamm ad Arshad President, Pakistan Veterinary Medical Council 216 -do- Pri-Protocid plus Form-5 Fa-trybinal by Approved Injection M/s Fatro 07-09-2012 vide Each ml injection diary No. 109 The firm is GMP contains:- Diminazine Rs.8,000 & 21- compliant as per aceturate.…….50mg 08-2013 inspection dated Rs.12,000 vide 03-05- 2015. (297) Antipyrine…….350mg diary 1091 R&I
Antiprotozoan/NSAID Decontrolled/50 ml Manufacture’s Specifications 217 -do- Pri-Tolevit + SE Form-5 Vit-E50 plus Sel Approved Injection by M/s Farvet 17-02-2012 vide Each ml injection diary No. 102 The firm is GMP contains:- Vitamin E as Rs.8,000 & 21- compliant as per Acetate.…….50mg 08-2013 inspection dated Rs.12,000 vide 03-05- 2015.
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(219) diary 1078 R&I Sodium Selenite……0.5mg Decontrolled/100 ml Vitamin & Mineral Manufacturer’s Specifications 218 -do- Pri-Meriforte Injection Form-5 Approved Arsonyl Injection Each ml injection 17-02-2012 vide by M/s Guyton contains:- Disodium diary No.99 Pharma Arsono- Rs.8,000 & 21- Acetate.…….50mg 08-2013 The firm is GMP (213) Rs.12,000 vide compliant as per Arsenic compound diary 1088 R&I inspection dated 03-05- 2015. Manufacturer’s Decontrolled/10 Specifications ml 219 -do- Dexa-Pri Injection Form-5 Deferred for Dexacare the Each ml injection 22-10-2012 vide Injection by M/s confirmation contains:- Rs.8,000 & 22- Leads/vetycare from CLB Dexamethasone as 10-2012 Pharma for segregated Sodium Rs.12,000 vide Phosphate.…….2mg diary 1130 R&I manufacturin (303) The firm is GMP g facility for dated 1-11-2012 compliant as per manufacturin Corticosteroid inspection dated g of steroid Decontrolled/50 03-05- 2015. injection. USP specifications ml 220 -do- Mepracort Injection Form-5 Deferred for the approval Each ml injection 22-10-2012 vide status in contains:- Mepyramine Rs.8,000 & 22- Pakistan and as Maleate.…….25mg 10-2012 confirmation from (305) Rs.12,000 vide Dexamethasone as diary 1128 R&I Licensing sodium Division for dated 1-11-2012 segregated phosphate…….2mg manufacturin Decontrolled/50 g facility for Antihistamin/steroid ml manufacturin g of steroid Manufacturer’s injection. Specifications 221 -do- Pri-Mag 25 Injection Form-5 Deferred for the Each ml injection 22-10-2012 vide The firm is GMP confirmation contains:- Magnesium Rs.8,000 & 22- of me too Minutes for 257th Registration Board Meeting 90
Sulphate.…….250mg 10-2012 compliant as per status. Rs.12,000 vide inspection dated Mineral diary 1127 R&I 03-05- 2015. (306) dated 1-11-2012 B.P Specifications Decontrolled/400 ml
222 -do- Pri-Cortisone 2.5% Form-5 Deferred Injection Predison 2.5% confirmation 22-10-2012 vide Injection by M/s from Each ml injection Rs.8,000 & 22- Manhattan Licensing contains:- Prednisolone 10-2012 Pharma Division for segregated as acetate.…….25mg Rs.12,000 vide manufacturin (311) diary 1120 R&I The firm is GMP corticosteroid g facility for dated 1-11-2012 compliant as per manufacturin inspection dated USP Specifications g of steroid Decontrolled/50 03-05- 2015. injection. ml 223 -do- Pri-Lincogent Injection Form-5 Deferred for the Each ml injection 22-10-2012 vide confirmation contains:- Lincomycin Rs.8,000 & 22- of me too as HCl.…….100mg 10-2012 status. (314) Rs.12,000 vide Gentamycin as diary 1122 R&I Sulphate……..40mg dated 1-11-2012
Antibiotic Decontrolled/50 ml Manufacturer’s Specifications 224 -do- Pri-Metaforce Injection Form-5 Deferred for Metabolase confirmation Each 100ml injection 22-10-2012 injection by M/s of me too contains:- Rs.8,000 & 22- Fatro status 10-2012 L-carnitine Rs.12,000 vide The firm is GMP HCl.…….613.3mg diary 1123 compliant as per inspection dated Thioctic Acid…….20mg Decontrolled/ 03-05- 2015. 50ml Pyridoxine as
HCl……15mg
(310) Cyanocobalamine…..3m g
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DL- Acetylmethionine…..20 00mg
L-Arginine……240mg
L-Ornithine as HCl…153.2mg
L-Citrulline…..120mg
L-Lysine as HCl….62.5mg
Glycine…150mg
Taurine……150mg
Aspartic Acid……..150mg
Glutamic Acid……150mg
Fructose……5000mg
Sorbitol……8000mg
Amino acids & sugar
Manufacturer,s Specification 225 -do- Pri-Vitalcom Injection Form-5 Aminowan by Deferred for M/s Nawan confirmation Each ml injection 22-10-2012 of me too contains:- Rs.8,000 & 22- The firm is GMP status 10-2012 compliant as per L-Arginine Rs.12,000 vide inspection dated HCl.…….1.44mg diary 1132 03-05- 2015. (301) L-Cysteine as Decontrolled/50 HCl…….3.20mg ml
L- Glutamine……3.20mg
Glycine…..3.20mg
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L-Histidine…..1.32mg
L-Leucine as HCl…4.28mg
L-Isoleucine…3.60mg
L-Lysine as HCl…..5.44mg
L-Methionine….3.20mg
L-Threonine…3.20mg
L-Tryptophan…0.86mg
L- Phenylalanine…..5.0mg
L-Valine……3.60mg
Thiamine as HCl……4.00mg
Ribaflavin as Sodium Phosphate……0.17mg
Pyridoxine as HCl…..0.34mg
Nicotinamide…8.00mg
Ascorbic acid…..4.00mg
Glucose……33mg
Calcium Chloride…..0.08mg
Potassium Chloride…….0.21mg
Magnesium Sulphate……..0.08mg
Combinations Amino acids Vitamins & electrolytes
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Manufacturer,s Specification 226 -do- Pri-Polyvit Oral Liquid Form-5 Deferred for Me to require to confirmation Each ml oral liquid 07-09-2012 vide be verified. of me too contains:- Vitamin diary No. 108 status A.…….100,000IU (R&I) Rs.8,000 (294) & 21-08-2013 Vitamin D3….20,000IU vide diary 1083 Rs.12,000 Vitamin E (Acetate)……..40IU Decontrolled/50 ml Vitamin Manufacturer’s Specification 227 -do- Prifen 10% Oral Liquid Form-5 Approved Hunter 10% Each 100ml oral liquid 07-09-2012 vide liquid by M/s contains:- diary No. 105 Cherished Pharma (R&I) Rs.8,000 (296) Fenbendazole.….10gm & 21-08-2013 The firm is GMP vide diary 1094 compliant as per Anthelmintic Rs.12,000 inspection dated 03-05- 2015. Manufacturer’s Decontrolled/100 Specifications ml, 200ml, 500ml 1000ml & 5litre
228 -do- Feban 2.5% Oral Drench Form-5 Approved Rintal 2.5% Each 100ml oral liquid 07-09-2012 vide solution by M/s contains:- diary No. 106 Bayer (R&I) Rs.8,000 Febantel…….2.5gm & 21-08-2013 The firm is GMP vide diary 1080 compliant as per (295) Probenzimidiazole Rs.12,000 inspection dated 03-05- 2015. Manufacturer’s Decontrolled/100 Specifications ml, 250ml, 500ml, 1000ml,
229 M/s Levosul 25mg Tablet Form 5 Rejected as Medicraft, 21-05-2012, vide the Phrma, Each tablet contains:- Dy No. 206-226 formulation Minutes for 257th Registration Board Meeting 94
Peshawar. Levosulpiride.….25mg R&I Rs.8,000 is not Antipsychotic approved by reference drug (1612) regulatory agencies 230 -do- Levosul 50mg Tablet Form 5 Rejected as 21-05-2012, vide the Each tablet contains:- Dy No. 206-226 formulation Levosulpiride.….50mg R&I Rs.8,000 is not (1613) Antipsychotic approved by reference drug regulatory agencies 231 -do- Levosul 100mg Tablet Form 5 Rejected as 21-05-2012, vide the Each tablet contains:- Dy No. 206-226 formulation Levosulpiride.….100mg R&I Rs.8,000 is not (1614) Antipsychotic approved by reference drug regulatory agencies 232 -do- Zinkmed Syrup 60ml Form 5 Deferred for 21-05-2012, vide Commemts/ Each 5ml contains:- Dy No. 206-226 opinion of Zinc Sulphate as R&I Kilin Syrup by WHO (1618) Monohydrate……20mg Rs.60/pack M/s Linear Pakistan. Pharma. Zinc Supplement
Manufacturer’s Specifications 233 M/s Tabros Liptin Tablet 50mg Form 5 MHRA. Galvus Approved Pharma (Pvt) 27-02-2013, vide 50mg tablet by Ltd, Karachi. Each film coated tablet Dy No. 838 R&I M/s Novartis contains:- Rs.20000 Local. Galvus Vildagliptin…….50mg Rs.89.28/tablet 50mg by M/s Antidiabetic Novartis. Manufacturer’s Panel vide (1710) Specifications inspection dated 08-03-2015 recommends the renewal DML
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234 M/s Getz Acuria Injection Form 5 MHRA. Approved Pharma (Pvt) 25mg/2.5ml 12-12-2012, vide Atracurium Ltd, Karachi. Dy No. 2243 10mg/ml solution Each 2.5ml injection R&I Rs.20000 for contains:- Rs.850/ampoule injection/infusion (2051) Atracurium by M/s Actavis Besylate………..25mg Local. Curim Neuromuscular 2.5ml injection by Blocking Agent M/s Global. USP Specifications 235 -do- Acuria Injection 30mg/3ml Form 5 Deferred for 12-12-2012, vide Local. Acuron the Each 3ml injection Dy No. 2241 3ml injection by confirmation (2054) contains:- R&I Rs.20000 M/s Brookes. of approval Atracurium Rs.1000/ status in reference Besylate………..30mg ampoule authorities Neuromuscular Blocking Agent USP Specifications 236 M/s Irsil-D Table 300/25mg. Form 5 MHRA. Approved Pharmevo CoAprovel (Pvt) Ltd, Each tablet contains:- 15-10-2012, vide 300/25mg f/c as Karachi. Irbesartan……..300mg Dy No. 1262 by M/s Sanofi Hydrochlorothiazide… R&I Rs.20000 Local. …..25mg Rs.420/10’s Firm is GMP Anti-hypertensive tablet compliant as per (1908) inspection dated Manufacturer’s april 2014-march Specifications 2015
237 -do- Acelar Plus Table Form 5 FDA. Vaseretic Approved 10/25mg. 10/25mg by M/s 25-10-2012, vide Valeant Each tablet contains:- Dy No. 1349 Local.Co-Renitec (1958) Enalapril…………….... R&I Rs.20000 10/25mg by M/s 10mg Merck Sharp Hydrochlorothiazide… Rs.200/10’s …..25mg tablet
Anti-hypertensive
USP Specifications 238 -do- Diatec 50mg Capsule. Form 5 Available in Deferred as EMA with the Each capsule contains:- 25-10-2012, vide restrictions. formulation is under
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Diacerin……………...... Dy No. 1351 review / (1959) 50mg R&I Rs.20000 Diora Capsule 50 expert mg by Getz opinion. Osteoarthritis Rs.450/10’s capsule Manufacturer’s Specification 239 M/s Bonky Injection. Form 5 FDA. Calcijex Approved Pharmatec 0.001mg/ml Pakistan Each ml contains:- 23-11-2012, vide Abbvie (Pvt) Ltd, Calcitriol……….……… Dy No. 2167 Karachi. 1mcg R&I Rs.20000 Local. Calcijex injection by M/s Calcium stimulant As per SRO Abbott Firm is GMP (2015) Manufacturer’s compliant as per Specifications inspection dated 23-09-2015 by area FID.
240 M/s Genix Metlin 2.5/850mg Tablet Form 5D MHRA. Deferred for Pharma (Pvt) Jentadueto the Ltd, Karachi Each film coated tablet 14-11-2012, vide 2.5/850mg f/c by evaluation in contains:- Dy No. 2119 M/s Boehringer light of IPO Linagliptin……….…… R&I Rs.20000 reply …2.5mg Firm is operating Metformin As per SRO at acceptable (2090) HCl………..850mg level of GMP compliance as per Antidiabetic inspection dated 14-04-2015 Manufacturer’s Specifications 241 M/s Obsons Levob 25mg Tablet Form 5 Rejected as Pharmaceutic Each tablet contains:- 22-06-2011, vide the als, 209-S, Levosulpiride Dy No. 2706 formulation Industrial ……….………25mg R&I Rs.8000 & is not Estate Kot Gastroprokinetic 19-12-2013 Dy approved by Lakhpat, No. 1279 reference Lahore. Rs.12000 drug As per SRO regulatory (1173) agencies 242 M/s Care Optimox Eye Drops Form 5 MHRA.Moxivig Approved Pharmaceutic Each ml contains:- 20-07-2012, vide 0.5% w/v by M/s als, 8- Moxifloxacin Dy No. 7446 Alcon. km,Thokar HCl…….……0.5%w/v R&I Rs.8000 & Local. Omox eye
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Raiwind Antibiotic 30-07-2013 Dy Drops 0.5% by road, Lahore. No. 9321 M/s Panacea. Rs.12000 Firm is GMP As per SRO compliant as per (1795) inspection by area FID.
243 -do- Optimox D Eye Drops Form 5 Deferred for Each ml contains:- 20-10-2011, vide Local. Oxcin eye the Moxifloxacin Dy No. 233 R&I drops o.1% & confirmation HCl…….……0.5%w/v Rs.8000 & 30- 0.5% by M/s Atco of approval Dexamethasone 07-2013 Dy No. status by reference (1399) Disodium Phosphate eq 9317 Rs.12000 Firm is GMP regulatory to Dexamethasone As per SRO compliant as per authorities Phosphate…..0.1% inspection by area Antibiotic/steroid FID.
244 -do- Florometh Eye Drops Form-5 FML by M/s Approved Eye Drops Dy. No: 7443 Allergan USFDA, dated. MHRA Each ml contains: 20-07-2012 Fluorometholone USP Rs.8,000/- FML By Barrett ...0.1% 03-07-2013 Hodgson Pakistan (1796) Rs.12,000/- (Steroidal Derivative) Rs: 60/ 5ml Firm is GMP compliant as per Manufacturer Specs inspection by area FID.
245 -do- Occubetan Eye Drops Form-5 Require to be Deferred for verified the Each ml contains:- Dy No. 7444 confirmation Neomycin dated 20-07- Betatek-N Drops of approval Sulphate...0.5%w/v 2012 Rs.8000 & by M/s Innvotek status in reference of Betamethasone Sodium Rs.12,000 dated Pharma drug (1215) Phosphate….0.1%w/v 30-07-2013 Firm is GMP authorities. compliant as per Antibiotic/Corticosteride Rs.50/7.5ml inspection by area bottle. FID. Manufacturer’s Specifications. 246 -do- Zincar Syrup Form-5 Require to be Deferred for verified comments/op Each 5ml contains:- Dy No. 1063 Diazinc syrup by nion from Zinc Sulphate dated 24-05- M/s Searle WHO Pakistan.
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(1441) Monohydrate 2011 Rs.8000 & aselemental Zinc Rs.12,000 dated Firm is GMP ...20mg 30-07-2013 compliant as per inspection by area Mineral Rs.80/60ml FID. bottle. Manufacturer’s Specifications. 247 -do- Neobat Cream Form-5 Betnovate N Approved Dy No. 1061 cream Each gram contains:- dated 24-05- Betamethasone Valerate 2011 Rs.8000 & Betnovate N ....0.1% Neomycin Rs.12,000 dated cream (1003) Sulphate….0.5% 30-07-2013 Rs.30/10gm Firm is GMP Corticosteride, antibiotic pack. compliant as per inspection by area Manufacturer’s FID. Specifications. 248 -do- Neobat Ointment Form-5 Approved Dy No. 299 Betnovate N Each gram contains:- dated 15-09- Ointment by M/s Betamethasone Valerate 2011 Rs.8000 & GSK ....0.1% Neomycin Rs.12,000 dated (1330) Sulphate….0.5% 30-07-2013 Firm is GMP Rs.30/10gm compliant as per Corticosteride, antibiotic pack. inspection by area FID. Manufacturer’s Specifications. 249 -do- Optilone Eye Drops Form-5 Deferred for Dy No. 7447 the Each ml contains:- dated 20-07- Solopred drops by confirmation (1797) Prednisolone USP 2012 Rs.8000 & M/s Jeans of approval ....0.1% Rs.12,000 dated status in reference 30-07-2013 Firm is GMP drug Corticosteride, Rs.30/10gm compliant as per authorities pack. inspection by area and USP Specifications. FID. manufacturin g facility 250 M/s Popular Metronidazole 400mg tablet Form 5 with fee MHRA Flagyl Approved Chemical Each tablet contains:- 8000/- Dy. 5307 400mg by M/s Metronidazole …..400mg Works Pvt Anti protozoal dated 14-06- Zentiva Ltd, Lahore. B.P Specifications 2012 & 12000/- (1715) dy. 687 dated 28- Local Flagyl by 10-2013 M/s Sanofi
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(1715) Rs.145/100tablet s pack 251 M/s PDH Ferrodin Injection Form-5 MHRA. Venofer Approved. Laboratories 100mg/5ml 100mg/5ml Registration (Pvt) Ltd, 17-08-2011 vide Local. Venofer Board Lahore. Each 5ml contains:- diary No. 1613 100mg. authorized its (R&I) Rs.8,000 chairman for Elemental & Rs.12000 issuance of Iron……..100mg as Iron dated 09-09- registration Sucrose letter after 2013 confirmation Hematinic of As per SRO differential fee challan USP Specifications from Budget & Accounts. 252 M/s Loxetine 60mg Capsule Form 5 MHRA.Cymbalta Approved Medicraft 07-06-2012, vide 30mg &60mg Pharmaceutic Each capsule contains:- Dy No. 2067 capsules by M/s al, 126-B, Duloxetine HCl R&I Rs.8,000 Eli Lilly Industrial ………60mg As per SRO Local. Delores Estate, 30, 60mg capsule Hayatabad, Serotonin and by M/s Fassgen Peshawar noradrenaline reuptake Firm is GMP inhibitor compliant as per inspection dated Manufacturer’s 29-07-2015. Specifications
M/s Vision Pharma Islamabad. 253 -do- Loxetine 30mg Capsule Form 5 MHRA.Cymbalta Approved 07-06-2012, vide 30mg &60mg Each capsule contains:- Dy No. 2068 R- capsules by M/s Duloxetine HCl IV Rs.8,000 Eli Lilly ….………30mg Rs.220/10’s Local. Delores 30, 60mg capsule Serotonin and by M/s Fassgen noradrenaline reuptake inhibitor
Manufacturer’s Specifications
M/s Vision Pharma Islamabad.
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254 -do- Prevexa 10mg Tablet Form 5 MHRA. Cipralex Approved 21-05-2012, vide 10mg f/c tablets Each film coated tablet Dy No. 206-226 by M/s Lundbeck contains:- R&I Rs.8,000 Ltd. Escitalopram Rs.300/14’s pack Local. Atcopram ………10mg 10mg & 20mg by M/s Atco Antidepressant
Manufacturer’s Specifications 255 -do- Prevexa 20mg Tablet Form 5 MHRA. Cipralex Approved 21-05-2012, vide 20mg f/c tablets Each tablet contains:- Dy No. 206-226 by M/s Lundbeck Escitalopram R&I Rs.8,000 Ltd. ………20mg Rs.385/14’s Local. Atcopram pack 10mg & 20mg by Antidepressant M/s Atco ` Manufacturer’s Specifications 256 -do- Relaxamed SR 4mg Tablet Form 5 MHRA. Approved 21-05-2012, vide Tizanidine 4mg Each tablet contains:- Dy No. 206-226 tablet by M/s Tizanidine ………4mg R&I Rs.8,000 Actavis Muscle Relexant Local. Zita tablet Rs.300/14’s pack 4mg By M/s Manufacture’s Gray’s Specifications 257 -do- Flumax 100mg Tablet Form 5 MHRA. Faverin Approved 21-05-2012, vide 100mg f/c tablet Each film coated tablet Dy No. 206-226 by M/s BGP contains:- R&I Rs.8,000 Local. B-Vert by Fluvoxamin as Maleate Rs.1130/30’s M/s Focus ………100mg pack
Muscle Relexant
Manufacture’s Specifications 258 -do- Pranodal 40mg Tablet Form 5 MHRA. Approved 07-06-2012, vide Propranolol 40mg Each film coated tablet Dy No. 2069 R- f/c tablet by M/s contains:- IV Rs.8,000 Accord Propranolol Rs.120/50’s pack Local. Inderal by ………40mg M/s ICI
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Beta Blocker
Manufacturer’s 259 -do- Pranodal 10mg Tablet Form 5 MHRA. Approved 07-06-2012, vide Propranolol 10mg Each film coated tablet Dy No. 2065 R- f/c tablet by M/s contains:- IV Rs.8,000 Accord Propranolol Rs.50/50’s pack Local. Inderal by ………10mg M/s ICI
Beta Blocker
Manufacturer’s 260 -do- Gent 80mg/2ml Injection Form 5 MHRA. Approved 21-05-2012, vide Cidomycin Each 2ml injection Dy No. 206-226 80mg/2ml by M/s contains:- R&I Rs.8000 Sanofi Gentamicin Rs.49/2x2ml Local. Cidomycin Sulphate……………… pack by M/s Sanofi …80mg Antibiotic/ aminoglycoside Manufacturer,s Specifications 261 M/s CKD Ecrolim Ointment 0.1% Form-5 MHRA. Protopic Deferred for Pharmaceutic 0.1% ointment by confirmation als Pakistan Each gram contains:- 24-12-2012 vide M/s Astellas of (Pvt) Ltd, diary No. 2303 Pharma manufacturin Karachi. Tacrolimus as (R&I) Rs.20,000 g facility for immunomod Local. Tacrus ulator / Monohydrate…..….0.1 Rs.425/5gm 0.1% ointment by Pack & immunosupp M/s Sharooq ressants %w/w 825/10gm pack
Immunomodulator
Manufacturer’s
Specifications.
262 -do- Ecrolim Ointment Form-5 MHRA. Protopic Deferred for 0.03% 0.03% ointment confirmation 24-12-2012 vide by M/s Astellas of Each gram contains:- diary No. 2304 Pharma. manufacturin (R&I) Rs.20,000 g facility for
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Tacrolimus as Local. Limus immunomod Rs.150/5gm 0.03% ointment ulator / Monohydrate.0.03%w/w Pack & by M/s immunosupp 275/10gm pack Nabiqasim ressants
Immunomodulator
Manufacturer’s
Specifications.
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M/s Safe Pharmaceuticals Pvt Ltd, Karachi. Firm initially applied following formulation:- Zerox Capsule 500mg Each capsule contains:- Azithromycin as Dihydrate……..500mg
Regsitration Board in its 250th meeting decided as under:- i. Applicants shall either revise their formulation to tablet dosage form, if not registered previously and if manufacturing facility is approved by CLB (new registration application with complete fee) or, ii. Shall submit Pharmaceutical development data including stability, bioavailability/ bioequivalence studies within six months period. iii. For already registered drugs, same procedure as mentioned above (at Sr. No. i & ii) shall be adopted. Otherwise show cause notice shall be issued for deregistration of drug in this formulation. All such application shall be processed on priority basis.” Decision: Decision: Deferred for confirmation from section whether the firm already has registration of same product or not.
Replies of deferred cases of previous meetings
M/s Medicon Pharma, Hayatabad, Peshawar:
Following applications of M/s Medicon Pharma, Hayatabad, Peshawar were considered in the 255th meeting of the board and were deferred for the submission of shortcomings listed in relevant column. Now the firm has submitted the documents in compliance to the decision of Registration Board.
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Sr. Brand Name Type of Form International Decision of Decision No. (Proprietary name + Initial date, diary status in 255th meeting Dosage Form + Fee including stringent drug Strength) differential fee regulatory Composition Demanded Price / agencies / Pharmacological Pack size authorities Group Me-too status Finished product GMP status Specification as depicted in latest inspection report (with date) by the Evaluator 263. Medipam 2mg Form-5 FDA, Ativan Form-5 is not Approved Tablet 10-09-2015, 0.5mg, 1mg, complete. Each tablet Diary # 125 R&I, & 2mg tablet The firm has contains:- Rs.20,000. by M/s applied on Lorazepam…….2m As per SRO Valeant Int. plain paper g without any Benzodiazepine Local Tablet letter head and B.P Specifications Ativan 1mg, the application 2mg by M/s is not signed Pfizer. by technical personels. Finished product specifications are not provided. Commitment as per decision of RB is not provided. In production the firm is claiming coating but complete description of the tablet is not provided. Approval of section is not provided. Drug is narcotic substance labelling and
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prescribing information are not provided.
264. Medipam 1mg Form-5 FDA, Ativan Form-5 is not Approved Tablet 10-09-2015, 0.5mg, 1mg, complete. Each tablet Diary # 124 R&I, & 2mg tablet The firm has contains:- Rs.20,000. by M/s applied on Lorazepam…….1m As per SRO Valeant Int. plain paper g without any Benzodiazepine Local Tablet letter head and B.P Specifications Ativan 1mg, the application 2mg by M/s is not signed Pfizer. by technical personels. Finished product specifications are not provided. Commitment as per decision of RB is not provided. In production the firm is claiming coating but complete description of the tablet is not provided. Approval of section is not provided. Drug is narcotic substance labelling and prescribing informations are not provided. For the assay of lorazepam
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potentiometer is required as submitted by the firm but not present in the list of equipments.
265. Diamed 10mg Form-5 FDA, Valium Form-5 is not Approved . Tablet 10-09-2015, tablet 2mg, complete. Each tablet Diary # 123 R&I, 5mg, & 10mg The firm has contains:- Rs.20,000. by M/s applied on Diazepam………..1 As per SRO Roche. plain paper 0mg without any Benzodiazepine Local Tablet letter head and B.P Specifications Valium 5mg, the application 10mg by M/s is not signed Martin Dow. by technical personels. Finished product specifications are not provided. Commitment as per decision of RB is not provided. In production the firm is claiming coating but complete description of the tablet is not provided. Approval of section is not provided. Drug is narcotic substance labeling and prescribing information
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are not provided.
266. Bromamed 3mg Form-5 TGA, Form-5 is not Approved . Tablet 10-09-2015, Lexotan 3mg, complete. Each tablet Diary # 120 R&I, 6mg tablet The firm has contains:- Rs.20,000. by M/s applied on Bromazepam……… As per SRO Roche. plain paper ..3mg without any Benzodiazepine Local Tablet letter head and Manufacturer’s Lexotanil the application Specifictions 3mg, by M/s is not signed Martin Dow. by technical personels. Finished product specifications are not provided. Commitment as per decision of RB is not provided. In production the firm is claiming coating but complete description of the tablet is not provided. Approval of section is not provided. Drug is narcotic substance labelling and prescribing informations are not provided. For the assay of lorazepam potentiometer is required as
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submitted by the firm but not present in the list of equipments.
267. Medilap 0.25mg Form-5 FDA, Xanax Form-5 is not Approved . Tablet 10-09-2015, 0.25mg, complete. Each tablet Diary # 119 R&I, 0.5mg, 1mg, The firm has contains:- Rs.20,000. 2mg tablet applied on Alprazolam……….. As per SRO by M/s plain paper 0.25mg Pharmacia & without any Benzodiazepine Upjohn. letter head and Manufacturer’s the application Specifications Local Tablet is not signed Xanax by technical 0.25mg, personels. 0.5mg & Finished 1mg, by M/s product Pfizer. specifications are not provided. Commitment as per decision of RB is not provided. In production the firm is claiming coating but complete description of the tablet is not provided. Approval of section is not provided. Drug is narcotic substance labeling and prescribing information are not provided. For the assay
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of lorazepam potentiometer is required as submitted by the firm but not present in the list of equipments.
268. Medilap 0.5mg Form-5 FDA, Xanax Form-5 is not Approved . Tablet 10-09-2015, 0.25mg, complete. Each tablet Diary # 119 R&I, 0.5mg, 1mg, The firm has contains:- Rs.20,000. 2mg tablet applied on Alprazolam……….. As per SRO by M/s plain paper 0.5mg Pharmacia & without any Benzodiazepine Upjohn. letter head and Manufacturer’s the application Specifications Local Tablet is not signed Xanax by technical 0.25mg, personels. 0.5mg &1mg, Finished by M/s product Pfizer. specifications are not provided. Commitment as per decision of RB is not provided. In production the firm is claiming coating but complete description of the tablet is not provided. Approval of section is not provided. Drug is narcotic substance labelling and prescribing informations
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are not provided. For the assay of lorazepam potentiometer is required as submitted by the firm but not present in the list of equipments. 269. Medilap 0.5mg Form-5 FDA, Xanax Form-5 is not Approved . Tablet 10-09-2015, 0.25mg, complete. Each tablet Diary # 119 R&I, 0.5mg, 1mg, The firm has contains:- Rs.20,000. 2mg tablet applied on Alprazolam……….. As per SRO by M/s plain paper 1mg Pharmacia & without any Benzodiazepine Upjohn. letter head and Manufacturer’s the application Specifications Local Tablet is not signed Xanax by technical 0.25mg, personels. 0.5mg & Finished 1mg, by M/s product Pfizer. specifications are not provided. Commitment as per decision of RB is not provided. In production the firm is claiming coating but complete description of the tablet is not provided. Approval of section is not provided. Drug is narcotic substance labelling and
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prescribing informations are not provided. For the assay of lorazepam potentiometer is required as submitted by the firm but not present in the list of equipments.
M/s Jawa Pharma, Lahore:
Following applications of M/s Jawa Pharma, Lahore were considered in the 254th meeting of the board and were deferred for the submission of shortcomings listed in relevant column. Now the firm has submitted the documents in compliance to the decision of registration Board.
270. Biocheck Form-5 UK. Deferred for Approved Solution 02-11-2015 diary Hibicet confirmation of Each 100ml #1780 Rs.20000 Hospital approval by contains:- As per SRO/60ml, Concentr reference drug Chlorhexidine 250ml, 500ml & ate by regulatory Gluconate 1000ml M/s authorities B.P…..….. 1.5g Regent (1.5%) Medical Cetrimide Ltd. UK B.P…….15gm PL. (15%) 22099/00 Anti-infective 02 & disinfectant Fakcidine Manufacturer’s Solution Specifications. by M/s Pharmaw ise
271. Clincin Lotion Form-5 UK. Deferred for Approved Each ml 19-10-2015 diary Dalacin T rectification of contains:- #1467 Rs.20000 Lotion following: Clindamycin As per SRO/30ml by M/s Address Phosphate eq to & 60ml. Pfizer provided at form Clindamycin…. Pharma 5 is incomplete. .….. 10mg Internationally
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Antibacterial Dalacin T availability is not U.S.P Lotion provided by the Specifications. by M/s firm. Pfizer Manufacturing Pharma method is incomplete as the firm has not mentioned temperature for manufacturing. Raw material specifications are not provided.
272. Clodrm Lotion Form-5 FDA. Deferred for Approved Each ml 19-10-2015 diary Clobex rectification of contains:- #1469 Rs.20000 (Clobetas following: Clobetasol As per SRO/20ml ol Address Proprionate….. & 60ml Propionat provided at form ….. 0.5mg e) 0.05% 5 is incomplete. Corticosteroid by M/s Internationally U.S.P DPT availability is not Specifications. Laborator provided by the ies firm. Manufacturing Local. method is Clobeder incomplete as m Lotion the firm has not by M/s mentioned Atco temperature for Pharma manufacturing. Raw material specifications are not provided. In USP it is present as solution. Requires confirmation of segregated facility for the dispensing of steroids. 273. Novat-S Form-5 Diprosali Deferred for Approved Solution 19-10-2015 diary c Lotion Calculations Each ml #1461 Rs.20000 are not
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contains:- As per SRO/20ml Provate-S provided in Betamethasone & 60ml Lotion salt & base (as by M/s form. Dipropionate) Saffron Address …..….. 0.5mg Pharma provided at (.05%) Reg.No. form 5 is Salicylic 060354 incomplete. Acid……..20m Internationally g (2%) availability is Corticosteroid+ not provided Keratolytic by the firm. agent Manufacturin B.P g method is Specifications incomplete as require to be the firm has submitted. not mentioned temperature for manufacturing . Raw material specifications are not provided. The firm has mentioned the reference of B.P but the formulation is not present in B.P. 274. Clotri Lotion Form-5 MHRA. Address Approved 1% 19-10-2015 diary Canesten provided at form Each ml #1471 Rs.20000 Solution 5 is incomplete. contains:- As per SRO/20ml 1% by Internationally Clotrimazole…. & 60ml M/s availability is not .…. 10mg Bayer Plc provided by the Antifungal Stiemazol firm. U.S.P Lotion Manufacturing Specifications. by M/s method is GSK incomplete as Pharma the firm has not mentioned temperature for manufacturing. Raw material
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specifications are not provided. The firm has mentioned the reference of B.P but the formulation is not present in B.P. 275. Septol Solution Form-5 Savlon Deferred for Approved Each 100ml 02-11-2015 diary Antisepti confirmation of contains:- #1781 Rs.20000 c Liquid approval by Chlorhexidine As per SRO/60ml, 3% & reference drug Gluconate 250ml, 500ml & 0.3% by regulatory B.P…..….. 1000ml M/s authorities 300mg (0.3%) Novartis Cetrmide Consume B.P…….3gm r Health (3%) UK Anti-infective Savtol & disinfectant Solution Manufacturer’s by M/s Specifications. Pharmaw ise 276. Piodine Form-5 MHRA. Deferred for Approved with Solution 10% 19-10-2015 diary Povidone rectification of change of name. Each 100ml #1468 Rs.20000 Iodine following: contains:- As per SRO/60ml 10% by Address Povidone- & 450ml M/s provided at form Iodine…..….. Ecolab. 5 is incomplete. 10gm Prodine Internationally Antiseptic Solution availability is not B.P by M/s provided by the Specifications. Kohinoor firm. Industries Manufacturing method is incomplete as the firm has not mentioned temperature for manufacturing. Raw material specifications are not provided.
277. Denol Liquid Form-5 Dettol Deferred for Approved with
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4.8% 19-10-2015 diary Solution rectification of change of name. Each 100ml #1456 Rs.20000 by M/s following: contains:- As per Reckett Address Chloroxylenol SRO/50ml,100ml Benckiser provided at form …..….. 4.8gm &500ml. 5 is incomplete. Antiseptic Internationally B.P availability is not Specifications. provided by the firm. Manufacturing method is incomplete as the firm has not mentioned temperature for manufacturing. Raw material specifications are not provided.
278. Darphin Form-5 FDA Deferred for Deferred for Injection 1gm 19-10-2015 diary Velosef confirmation of confirmation of Each vial #1475 Rs.20000 Injection approval status approval status in contains:- As per SRO 1gm by in reference reference Cephradine….. M/s regulatory regulatory authorities. ….. 1gm Apotheco authorities. Moreover, product Cephalosporin n Moreover, has been B.P product has been discontinued by Specifications Veloef discontinued by USFDA. Injection USFDA. 1gm by M/s GSK 279. Darphin Form-5 FDA Deferred for Deferred for Injection 500mg 19-10-2015 diary Velosef confirmation of confirmation of Each vial #1436 Rs.20000 Injection approval status approval status in contains:- As per SRO 500mg in reference reference Cephradine….. by M/s regulatory regulatory authorities. ….. 500mg Apotheco authorities. Moreover, product Cephalosporin n Moreover, has been B.P product has been discontinued by Specifications Veloef discontinued by USFDA. Injection USFDA. 500mg by M/s GSK
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M/s 3N-Lifemed Pharmaceuticals, 45 S.B, Abdullah Colony, Sargodha:
Following applications of M/s 3N-Lifemed Pharmaceuticals, 45 S.B, Abdullah Colony, Sargodha were considered in the 256th meeting of the board and were deferred for the submission of shortcomings listed in relevant column and for expert opinion. Now the firm has submitted the documents in compliance to the decision of registration Board and opinion of Nepharologists from Sh. Zaid Hospital Dr. Waqar, SIMS, Lahore Dr. Zahid Rafique AP Nepharology and PIMS Dr Muhammad Ramza senior Registrar. The firm has requested to consider their applications for the approval.
280. Lifemed Bicarb Concentrate Form-5 Renacon Deferred for Deferred (3NLBS-35X) 14-12-2015 vide Pharma s submission of for After final mixing /diluting diary No. 2718 following:- confirmati by 35X Haemodialysis Rs.20,000 Confirmation on of machines with deionized As per SRO of me too approval status of water, the strength of active status and same ingredients of part-A & part- approval by dosage B Haemodialysis concentrate reference regulatory form in are: authorities. same Sodium……… 138.0m Finished strength in mol/l product reference Potassium……. 2.0m mol/l specifications. regulatory Calcium……… 1.25m Complete authorities mol/l calculations of and Magnesium…… 0.75m mol/l the formulatin. Pakistan. Acetic acid……. 5.0m The Board further mol/l directed to seek Chloride……… 107.0 m opinion on all mol/l dialysis concentrate Bicarbonate……35.0m mol/l applications from:- Glucose………..5.5 m mol/l Prof Shaheen Concentrate for Bicarbonate Moeen, Bahria Haemodialysis Medical college, B.P specifications and Head of Deptt Nephrology PIMS. 281. Lifemed Bicarb Concentrate Form 5 Renacon Deferred for Deferred (3NLBP-35X) 14-12-2015 vide Pharma s submission of for After final mixing /diluting diary No. 2716 following:- confirmati by 35X Haemodialysis Rs.20,000 Confirmation on of machines with deionized As per SRO of me too approval status of water, the strength of active status and same ingredients of part-B approval by dosage Haemodialysis concentrate reference regulatory form in Minutes for 257th Registration Board Meeting 117
are: authorities. same Sodium………….35.0 m Finished strength in mol/l product reference Bicarbonate…….35.0 m specifications. regulatory mol/l Complete authorities and Concentrate for Bicarbonate calculations of Pakistan. Haemodialysis the formulatin. B.P specifications The Board further . directed to seek opinion on all dialysis concentrate applications from:- Prof Shaheen Moeen, Bahria Medical college, and Head of Deptt Nephrology PIMS. 282. Lifemed Bicarb Concentrate Form-5 Renacon Deferred for Deferred (3NLBA-35X) 14-12-2015 vide Pharma s submission of for After final mixing /diluting diary No. 2715 following:- confirmati by 35X Haemodialysis Rs.20,000 Confirmation on of machines with deionized As per SRO of me too approval status of water, the strength of active status and same ingredients of part-A approval by dosage Haemodialysis concentrate reference regulatory form in are: authorities. same Sodium……… 103.0 m Finished strength in mol/l product reference Potassium……. 2.0m mol/l specifications. regulatory Calcium……… 1.25m Complete authorities mol/l calculations of and Magnesium…… 0.75m mol/l the formulatin. Pakistan. Acetic acid……. 5.0m The Board further mol/l directed to seek Chloride……… 107.0 m opinion on all mol/l dialysis concentrate Glucose……….. 5.5 applications from:- m mol/l Prof Shaheen Moeen, Bahria Medical college, Concentrate for Bicarbonate and Head of Deptt Haemodialysis Nephrology PIMS. B.P specifications
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283. Lifemed Bicarb Concentrate Form-5 Renacon Deferred for Deferred (3NLBG-36.83X) 14-12-2015 vide Pharma s submission of for After final mixing /diluting diary No. 2717 following:- confirmati by 36.83X Haemodialysis Rs.20,000 Confirmation on of machines with deionized As per SRO of me too approval status of water, the strength of active status and same ingredients of part-A & part- approval by dosage B Haemodialysis concentrate reference regulatory form in are: authorities. same Sodium……… 140.0m Finished strength in mol/l product reference Potassium……. 2.5 m mol/l specifications. regulatory Calcium……… 1.25m Complete authorities mol/l calculations of and Magnesium…… 0.75m mol/l the formulatin. Pakistan. Acetic acid……. 5.0m The Board further mol/l directed to seek Chloride……… 108.5 m opinion on all mol/l dialysis concentrate Bicarbonate……36.0m mol/l applications from:- Dextrose……….. 11 Prof Shaheen m mol/l Moeen, Bahria Medical college, and Head of Deptt Concentrate for Bicarbonate Nephrology PIMS. Haemodialysis B.P specifications 284. Lifemed Bicarb Concentrate Form-5 Renacon Deferred for Deferred (3NLPS-35X) 19-1-2016 vide Pharma s submission of for After final mixing /diluting diary No. 409 following:- confirmati by 35X Haemodialysis Rs.20,000 Confirmation on of machines with deionized As per SRO of me too approval status of water, the strength of active status and same ingredients of part-A, part-B approval by dosage & part C Haemodialysis reference regulatory form in concentrate are: authorities. same Sodium……… 138.0m Finished strength in mol/l product reference Potassium……. 2.0m mol/l specifications. regulatory Calcium……… 1.50 m Complete authorities mol/l calculations of and Magnesium…… 0.75m mol/l the formulatin. Pakistan. Acetic acid……. 5.0m The Board further mol/l directed to seek Chloride……… 107.25 m opinion on all mol/l dialysis concentrate
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Bicarbonate……35.0m mol/l applications from:- Glucose……….. 5.5 Prof Shaheen m mol/l Moeen, Bahria Concentrate for Bicarbonate Medical college, Haemodialysis and Head of Deptt B.P specifications Nephrology PIMS. 285. Lifemed Bicarb Concentrate Form-5 Deferred for Deferred (3NLPG-36.83X) 19-1-2016 vide submission of for After final mixing /diluting diary No. 410 Renacon following:- confirmati by 36.83X Haemodialysis Rs.20,000 Pharma s Confirmation on of machines with deionized Single of me too approval status of water, the strength of active Haemodialysis status and same ingredients of part-A Session, 5 approval by dosage (Powder) & part-B (Powder) haemodialysis reference regulatory form in & part C (Liquid) Session, 10 authorities. same Haemodialysis concentrate haemodialysis Finished strength in are: session /As per product reference Sodium……… 140.0m SRO specifications. regulatory mol/l Complete authorities Potassium……. 2.0m mol/l calculations of and Calcium……… 2.5m the formulatin. Pakistan. mol/l The Board further Magnesium…… 1.0 m mol/l directed to seek Aceticacid……. 4.0m opinion on all mol/l dialysis concentrate Chloride……… 106.5 m applications from:- mol/l Prof Shaheen Bicarbonate……39.0m mol/l Moeen, Bahria Destrose……….. 200 Medical college, mg/dl and Head of Deptt Concentrate for Bicarbonate Nephrology PIMS. Haemodialysis B.P Specifications.
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M/s Intervac (Pvt) Ltd, 18 Km Lahore:
Following applications of M/s Intervac (Pvt) Ltd, 18 Km Lahore were considered in the 256th meeting of the board and were deferred for the submission of shortcomings listed in relevant column. Now the firm has submitted the documents in compliance to the decision of registration Board.
286. Prostifas Injection Form 5 Fertagyl Deferred for Deferred from Each ml contains:- 28-04-2011 diary # injection by submission of Licensing Cloprostenol Sodium B.P 210 R&I Rs.8000 M/s Mylab. following:- Division, 263 mcg eq to & Dy No.717 25- Copy of DRAP for Cloprostenol 250mcg 07-2013 Rs.12000 Challan of confirmation of dedicated Not provided Decontrolled / 2ml, The firm is differential fee facility for Manufacturer’s GMP of manufacturing Specifications compliant as 12000. of hormone per Approval injection inspection status in dated 09-12- Pakistan. 2015. Last inspection conducted within the period of 1 year. 287. Intervit Plus Injection Form 5 ______Deferred for Deferred for Each 100ml contains:- 28-04-2011 diary # submission of clarification of Vitamin A….5MIU 222 R&I Rs.8000 following:- me too status Vitamin D3…1MIU & Dy No.717 25- Uvevit plus Copy of and Vitamin E Acetate…2gm 07-2013 Rs.12000 injection Challan of application by the firm Vitamin C ….2.5gm Decontrolled differential fee Vitamin B1….600mg /100ml The firm is of Vitamin B2 …100mg GMP 12000. Vitamin B6…500mg compliant as Approval Vitamin B12…5mg per status in Nicotinamide…1gm inspection Pakistan. Calcium dated 09-12- Last Pantothenate….600mg 2015. inspection Biotin…5mg conducted Folic Acid….10mg within the Lysine…1mg period of 1 Methionine…1mg year. Copper Sulphate….10mg Zinc Sulphate…10mg Magnesium
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Sulphate…10mg Vitamins & Minerals Manufacturer’s Specifications 288. Amivit Plus Injection Form 5 ______Deferred for Deferred for Each ml contains:- L- 28-04-2011 diary # submission of clarification of Arginine HCl….1.44mg 230 R&I Rs.8000 following:- me too status L-Cysteine HCl….3.20mg & Dy No.717 25- Firm has Copy of and L-Glutamine……3.20mg 07-2013 Rs.12000 provided but Challan of application by the firm Glycine……3.20mg it is incorrect differential fee L-Histidine….1.32mg Decontrolled of L-Isoleucine….3.60mg /100ml 12000. L-Lysine HCl..….5.44 The firm is Approval L-Methionine….3.20mg GMP status in L-threonine…3.20mg compliant as Pakistan. L-Tryptophan…0.86mg per Last L-Phenylalanine….5mg inspection inspection L-Valine….3.60mg dated 09-12- conducted Thiamine HCl….4mg 2015. within the Riboflavin Sodium period of 1 Phosphate….0.17mg year. Pyridoxine HCl…0.34mg Ascorbic Acid…4mg Glucose ….33mg Calcium Chloride…0.08mg Potassium Chloride….0.21mg Magnesium Chloride…0.08mg Amino acid, vitamins & electrolytes Manufacturer’s Specifications 289. Fluxifas Injection Form 5 ______Deferred for Approved. Each ml contains:- 28-04-2011 diary # submission of Flunixin as 203 R&I Rs.8000 following:- Meglumine….50mg & Dy No.717 25- Loxin Copy of Anti Inflammatory 07-2013 Rs.12000 Injection by Challan of Manufacturer’s M/s Selmore differential fee Specifications Decontrolled /10ml of The firm is 12000. GMP Last compliant as inspection per conducted inspection within the
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dated 09-12- period of 1 2015. year.
290. Mettycoli Injection Form 5 ______Deferred for Approved Each ml contains:- 28-04-2011 diary # submission of Dimetridazole…100mg 224 R&I Rs.8000 following:- Colistin Sulphate…..10mg & Dy No.717 25- Tycolimet Copy of Tylosin Tartrate….50mg 07-2013 Rs.12000 Injection by Challan of Antibiotic M/s Breeze differential fee Manufacturer’s Decontrolled / Pharma of Specifications 100ml 12000. Last The firm is inspection GMP conducted compliant as within the per period of 1 inspection year. dated 09-12- 2015. 291. Novafas Injection Form 5 ______Deferred for Approved Each ml contains:- 28-04-2011 diary # submission of Novaminsulfon…..40mg 205 R&I Rs.8000 following:- Etilefrin…..0.2mg & Dy No.717 dated Novamide Copy of Calcium 25-07-2013 Injection by Challan of Gluconate….110mg Rs.12000 M/s Guyton differential fee Magnesium Pharmaceutic of Gluconate….10mg Decontrolled / als.. 12000. Sodium Salicylate….7mg 500ml Last Nicotinamide….0.3mg inspection Caffeine…10mg The firm is conducted Boric Acid…10mg GMP within the Antibiotic and Supplement compliant as period of 1 Manufacturer’s per year. Specifications. inspection dated 09-12- 2015.
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M/S S.J. &G. Fazul Ellahie (Pvt) Limted. E-46, S.I.T.E., Karachi:
Following applications of M/S S.J.&G. Fazul Ellahie (Pvt) Limted. E-46, S.I.T.E., Karachi were considered in the 247th meeting of the board and were deferred for the submission of shortcomings listed in relevant column. Now the firm has submitted the documents in compliance to the decision of registration Board. 292. Prelin Capsule Form 5 LYRICA 1. Deferred for Approved rectification of Each Capsule Contains: Capsules (25, shortcomings in 50, 75, 100, preceding Pregabalin……225mg 26-08-2008 150,200, 225 column and 300mg) Rs.8000/- 2. Status of DML US FDA (Anti-epileptic) Dy. No. Not from licensing division mentioned
3. Final notice Local. Zegab Manufacturers specifications for rectification 225mg 02-05-2014 of shortcomings capsule by Rs.12000/- M/s Hilton Pharma. Dy. 651 R&I duplicate dossier / The product was deferred 14’s/ As per SRO in 247th meeting due to following Deferred for confirmation of me-too status. 2. Final notice for rectification of shortcomings/ observations. Now the firm has submitted the
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deficiencies.
M/s Nabiqasim Industries Pvt Ltd, Karachi:
The following products of M/s Nabiqasim Industries Pvt Ltd, Karachi were considered in the 254th meeting of the board and were deferred for the submission of shortcomings. Now the firm has submitted the shortcomings.
293. Modton Tablet 25mg Form 5-D MHRA. Deferred for Approved Valdoxan verification of the Each film coated tablet Rs. 52,000/- 25mg f/c fee challan. contains Agomelatine and 5000 tablet by M/s 25mg 24.01.2013 Servier and Antidepressant 08.05.2013 Local. Agloda Dy. No. tablet 25mg Manufacturer’s 1709 R&I by M/s specifications PharmEvo. Price: 1500/- per The product is pack deferred for 10’s the evaluation of registration as per approved checklist.
M/s Fynk Pharmaceuticals 19-Km G.T Road, Kalashah Kaku, Lahore:
The following products of M/s Fynk Pharmaceuticals 19-Km G.T Road, Kalashah Kaku, Lahore were considered in the 253rd meeting of the board and were deferred for the submission of shortcomings. Now the firm has submitted the shortcomings.
294. Fosmin Cream Form 5 Acutane of Defered for Deferred for Roche USA confirmation of confirmation of Contains:- R&I 1381, 04- as approved approval by approval status of Isotretinoin 03-2015 in 243rd regulatory same formulation B.P…0.05% w/w Rs.20,000 meeting authority of by reference regulatory Isotrol Cream reference
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Vitamin A analogue As per Valor Pharma countries. authorities (retinoid); Treatment SRO/10gm The product is of Acne deferred in 253rd Manufacturer’s meeting Specifications “Defered for confirmation of approval by regulatory authority of reference countries.” The firm has submitted that the same formulation has been approved for M/s Valor Pharma for Isotrol cream.
M/s ICI Pakistan Ltd, Life Sciences, 45-Km, Multan Road, Lahore :
The following products of M/s ICI Pakistan Ltd, Life Sciences, 45-Km, Multan Road, Lahore were considered in the 256th meeting of the board and were deferred for the submission of shortcomings. Now the firm has submitted the shortcomings.
295. Erythroprim-S Water Form 5 ______Deferred for the Deferred for Soluble Powder. 10-12-2015 submission of confirmation vide diary ERYTHRO-TS following:- of Each Kg contains:- No. 517 POWDER by Finished potentiometer. Erythromycin Rs.20,000. M/s Nawan product Thiocyanate……..100gm Decontrolled/ specifications. Trimethoprim…..20gm 100gm, The firm has Calculations Sulphadiazine as 250gm, submitted in Sodium…100gm 500gm, 1kg, replies of salt and base 5kg & 25kg deficiencies vide form. Antibacterial diary 1257 Proposed (R&I) dated 04- master Manufacturer’s 03-2016 formulation Specifications requires justification
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List of production equipments with GMP compliant. Potentiometer is mentioned inassay of trimethoprim and sulphadiazine but not present in equipment list. Complete list of technical persons involved in production and QC. On letter head scanned signature of business manager health. 296. Eflosin oral Powder. Form 5 ______Deferred for the Approved 10-12-2015 submission of Each Kg contains:- vide diary Hirra Tylo Plus following:- Tylosin Tartrate…..60gm No. 519 reg 029677 by Finished Erythromycin Rs.20,000. M/s Hirra product Thiocyanate……40gm Decontrolled/ Pharmaceuticals. specifications Furaltadone as 100gm, The firm has Approval HCl…150gm 250gm, submitted status 500gm, 1kg, replies of in Pakistan. Antibacterial 5kg & 25kg deficiencies vide Calculations diary 1256 in Manufacturer’s (R&I) dated 04- salt and base Specifications 03-2016 form. Proposed master formulation. List of production equipments with GMP
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compliant. Firm is claiming microbial assay method which requires confirmation of microlab. Complete list of technical persons involved inproduction and QC. On letter head scanned signature of business manager health. 297. Co-Spira water soluble Form 5 ______Deferred for the Approved Powder. 10-12-2015 submission of vide diary Spiralin WSP following:- Each Kg contains:- No. 518 Reg.063860 by Finished Spiramycin Rs.20,000. M/s Symans product adipate…..75gm Decontrolled/ specifications. Lincomycin HCl……25gm 100gm, The firm has Approval 250gm, submitted status Antibacterial 500gm, 1kg, replies of in Pakistan 5kg & 25kg deficiencies vide Calculations Manufacturer’s diary 1258 in specifications (R&I) dated 04- salt and base 03-2016 form are not provided. Proposed master formulation requires justification. List of production equipments with GMP compliant is not provided. Firm is
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claiming microbial assay method which requires confirmation of microlab. Complete list of technical persons involved in production and QC is not attached. Signatures of business manager, healthare scanned copies. M/s Friends Pharma, Lahore :
The following products of M/s Friends Pharma, Lahore were considered in the 255th meeting of the board and were deferred for the submission of shortcomings. Now the firm has submitted the shortcomings.
298. Artemose Injection Form-5 Same Label claim in Approved Injection Dy. No: 557 formulation is form 5 is dated. included in ambiguous and Each ml contains: 28-05-2011 EDL WHO not in Artemether……80mg Rs.8000/- conformity with Rs.12,000/- Falcigo by M/s master (Anti-Malarial) As per SRO Armos formulation. Pharmaceuticals Official Manufacturer’s Monograph of Specifications Excipient i.e. Archive oil is required. Commitment as per 251st meeting not provided by the Firm. Last inspection report is dated
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15-03-2011. Details of manufacturing method required. Official monograph for product required. Strength per ml along with volume per injection /ampoule required. 299. Ferifend Injection Form-5 International Commitment as Deferred for Dy. No: 547 availability not per 251st approval Each ml contains: dated. confirms. meeting not status of Piroxicam……….20mg 28-05-2011 provided by the same Rs.8000/- Feldene By M/s Firm. formulation in reference (Analgesic) Rs.12,000/- Pfizer Last inspection regulatory As per SRO Laboratories. report is dated authorities 15-03-2011. and for Official Finished Monograph of product Excipient i.e. specification. alcohol is required. Details of manufacturing method required. Official monograph for product required. Strength per ml along with volume per injection /ampoule required.
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300. Nootrofil Injection Form-5 International Commitment as Deferred for Injection Dy. No: 553 availability not per 251st approval dated. confirm meeting not status of Each ml contains: 28-05-2011 provided by the same Piracetam……..200mg Rs.8000/- Ceremin Firm. formulation in reference Rs.12,000/- injection by M/s Last inspection regulatory (Nootropic Drug) As per Schazoo labs. report is dated authorities SRO/200mg/ml 15-03-2011. and for Clarification Finished required that product product is specification. ampoule or vial. Official Monograph of Excipient i.e. alcohol is required. Master formulation not as per label claim. FTIR required for testing is not present in QC equipment list. 301. Levofend Infusion Form-5 MHRA. Evoxil Commitment as Approved Infusion Dy. No: 541 5mg/ml per 251st dated. solution for meeting not Each 100ml contains: 28-05-2011 infusion by M/s provided by the Levofloxacin……..500mg Rs.8000/- Beacon Firm. Rs.12,000/- Pharmaceuticals Last inspection (Anti-biotic) As per SRO/ report is dated 500mg/100ml Leflox By M/s 15-03-2011. Manufacturer’s Getz Label claim in Specifications FG specs is 200mg/100ml.
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M/s UDL Pharma, # 44-45 North West Industrial Zone, Port Qasim, Pakistan:
The following products of M/s UDL Pharma, # 44-45 North West Industrial Zone, Port Qasim, Pakistan were considered in the 254th meeting of the board and were deferred for the submission of shortcomings. Now the firm has submitted the shortcomings.
302. Xeroyn Dry Suspension Form 5 FDA. Deferred for Approved Each 5ml contains Dy No. 805 Clarithromycin confirmation clarithromycin granules dated 03-08- Oral of source of eq to 2015 Suspension granules and clariyhromycin….125mg Rs 20,000 Klaricid requisite fee Macrolide As per SRO 125mg/5ml USP Specifications Source of Granules. M/s Vision Pharma, Kahuta triangle, Islamabad.
M/s Sante (Pvt) Limited Karachi:
The following products of M/s Sante (Pvt) Limited Karachi were considered in the 254th meeting of the board and were deferred for the submission of commitment as approved by the board. Now the firm has submitted the commitment.
303. ZUREG Capsules 50mg Form-5 LYRICA Deferred for Approved Capsules (25, undertaking Each capsule contains: Dy. No 256 50, approved in Pregabalin…50mg dated 21-01-11 75, 100, 251st meeting 150,200, 225 of registration Anti-epileptic 8000 dated 21- and board. 01-11 300mg) Manufacturer 12000 dated 17- US FDA 04-14 GABICA Rs. 175/ pack of Capsules (50, 14’s 75, 100, 150 and 300mg) Getz
Inspection of the firm was carried out on
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28,29 May 2015 by the area FID where he concluded that management has positive attitude towards GMP complianace 304. ZUREG Capsules 75mg Form-5 LYRICA Deferred for Approved Capsules (25, undertaking Each capsule contains: Dy. No 257 50, approved in Pregabalin…75mg dated 21-01-11 75, 100, 251st meeting 150,200, 225 of registration Anti-epileptic 8000 dated 21- and board. 01-11 300mg) Manufacturer 12000 dated 17- US FDA 04-14 GABICA Rs. 250/ pack of Capsules (50, 14’s 75, 100, 150 and 300mg) Getz 305. ZUREG Capsules Form-5 LYRICA Deferred for Approved 100mg Capsules (25, undertaking Dy. No 260 50, approved in Each capsule contains: dated 21-01-11 75, 100, 251st meeting Pregabalin…100mg 150,200, 225 of registration 8000 dated 21- and board. Anti-epileptic 01-11 300mg) 12000 dated 17- US FDA Manufacturer 04-14 GABICA Rs. 250/ pack of Capsules (50, 14’s 75, 100, 150 and 300mg) Getz 306. ZUREG Capsules Form-5 LYRICA Deferred for Approved 300mg Capsules (25, undertaking Dy. No 261 50, approved in Each capsule contains: dated 21-01-11 75, 100, 251st meeting Pregabalin…300mg 150,200, 225 of registration
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8000 dated 21- and board. Anti-epileptic 01-11 300mg) 12000 dated 17- US FDA Manufacturer 04-14 GABICA Rs. 250/ pack of Capsules (50, 14’s 75, 100, 150 and 300mg) Getz
M/s Sami (Pvt) Limited Karachi:
The following products of M/s Sami (Pvt) Limited Karachi were considered in the 256th meeting of the board and were deferred for the submission of deficiencies mentioned in relevant column. Now the firm has submitted the deficiencies.
307. TULOSIN MR Form 5 EMA: Deferred for Approved 0.4mg Capsules Rs. 20,000/- Flomax confirmation (24-11-2014) MR whether Each Capsule vide diary # (Boehringer) application is contains: 138 & 80,000 FDA: Flomax for Modified vide diary No. (Boehringer) additional release pellets 258 dated 01- Tamsolin section or of Tamsulosin 02-2016 Regn. otherwise. HCl equivalent to Additional No. 050392 Now the Tamsulosin HCl Section (Getz)Grant section vide dy USP……. Capsule of No. 952/2016 …0.4mg additional dated 17-03- (Alpha- section – 2016 has Adrenerjic Capsule verified the Blocker) (General) additional USP specs (24- section 06-2014) product. source of pellets VERY “M/s RA Chem GOOD Pharma Ltd, The product Plot # A-19/C, is Road # 18, Deferred for IDA, source of Nacharam, pellets, Now Hyderabad- the 500076, firm has Telangana applied State, India”
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M/s Allmed PVT Ltd, Lahore:
The following product of (M/s Evergreen Pharmaceuticals, Lahore), now M/s Allmed PVT Ltd, Lahore was considered in the 254th meeting of the board and were deferred for the submission of deficiencies mentioned in relevant column. Now the firm has submitted the deficiencies.
308. A-Bone Injection IV Form 5 MHRA Deferred Approved ampoule/Oral Ampoule Rs. 20,000/- approved for with change vide Dy. No. One-Alpha Latest of brand Each ml contains 170 dated 15- Injection Inspection name Alfacalcidol BP …. 1 01-2011 & Dy (Leo, UK) report. Commitment mcg No. 1789 dated as per decision 11-10-2012 Alfadin of DRB. Vitamins, Mineral , Injection Outline of Tonic & other (Danas) manufacturing substances Pack size of method Ampoule of Verificatio (BP Specification) 15ml with n of fee proposed price for Title of as per brand firm has leader been changed to M/s Allmed.
M/s Hygeia Pharmaceuticals, 295Industrial Triangles, Kahuta Road, Islamabad:
The following product of M/s Hygeia Pharmaceuticals, 295Industrial Triangles, Kahuta Road, Islamabad was considered in the 254th meeting of the board and were deferred for the submission of deficiencies mentioned in relevant column. Now the firm has submitted the deficiencies.
309. Esoton-40mg Tablet Form-5 TGA Deferred for Approved Each enteric coated tablet 16-06-2011, Nesomep Complete contains diary No1211 40mg tablet description Esomeprazole….40mg Rs.8000 & 20- (Esomeprazo of the PPI 02-2013 diary le as tablet is not Manufacturer’s No. 415 Magnesium) provided. Specifications Rs.12000 Only Esmazole. Calculation Photocopies are 40mg tablet s in base & attached. by M/s salt is not As per SRO/30,s Global. provided. Firm is GMP Internation
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compliant as al status is per not inspection provided dated 08-12- by the firm. 2015. Outline method of manufactur e is not provided. Last inspection conducted within the period of 1 year is not provided. Original fee receipt of 12000 is not attached. Commitme nt as per decision of RB is require to be submitted.
M/s Getz Pharma (Pvt) Limited, 29-30-Sector 27, Korangi, Industrial Area, Karachi:
The following products of M/s Getz Pharma (Pvt) Limited, 29-30-Sector 27, Korangi, Industrial Area, Karachi were considered in the 253th meeting of the board and were deferred for the submission of deficiencies mentioned in relevant column. Now the firm has submitted the Form 5 along with commitment and informed that the products are already registered with M/s Highnoon Labs, Lahore and M/s Barrett Hodgson, Karachi. 310. TREVIAMET XR Form-5D Janumet XR Laboratory scale Deferred for Tablets (USFDA) scientifically rational submission of Dy. No : 1804 Local. Tagipmet stability data as per laboratory Each extended release dated 14-12- XR 50/500mg by requirements decided scale tablet contains: 12 M/s Highnoon in the 251st meeting scientifically rational Sitagliptin as Phosphate of Registration Board stability data monohydrate….50mg 50000 dated is required as per Minutes for 257th Registration Board Meeting 136
Metformin 12-12-12 requirements HCL…500mg decided in the st Rs. 101/- per 251 meeting DPP-4 & Biguanide tablet/ Pack of of 14’s & 30’s Registration Board. Manufacturer
311. TREVIAMET XR Form-5D Janumet XR Laboratory scale Deferred for Tablets (USFDA) scientifically rational submission of Dy. No 1803 Local. Tagipmet stability data as per laboratory Each extended release dated 14-12- XR 100/1000mg requirements decided scale tablet contains: 12 by M/s in the 251st meeting scientifically rational Sitagliptin as Phosphate Highnoon of Registration Board stability data monohydrate….100mg 50000 dated is required as per Metformin 12-12-12 requirements HCL…1000mg decided in the Rs. 169 /- per 251st meeting DPP-4 & Biguanide tablet/ Pack of of 14’s & 30’s Registration Manufacturer Board.
312. TREVIAMET XR Form-5D Janumet XR Laboratory scale Deferred for Tablets (USFDA) scientifically rational the Dy. No :1805 Local. Tagipmet stability data as per submission of Each extended release dated 14-12- XR 50/1000mg requirements decided laboratory tablet contains: 12 by M/s in the 251st meeting scale scientifically Sitagliptin as Phosphate Highnoon(243rd ) of Registration Board rational monohydrate….50mg 50000 dated is required stability data Metformin 12-12-12 as per HCL…1000mg requirements Rs. 102 /- per decided in the DPP-4 & Biguanide tablet/ Pack of 251st meeting 14’s & 30’s of Manufacturer Registration Board.
313. TREVIAMET Tablets Form-5D Janumet (EMA) Laboratory scale Deferred for Local. S-Gliptin scientifically rational submission of Each film coated tablet Dy. No :67 Plus 50/850mg stability data as per laboratory contains: dated 06-08- by M/s Barrett requirements decided scale Sitagliptin as Phosphate 11 (243) in the 251st meeting scientifically rational monohydrate….50mg of Registration Board stability data Metformin 15000 dated is required as per HCL…850mg 04-08-11 requirements
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35000 dated decided in the DPP-4 & Biguanide 30-07-13 251st meeting of Manufacturer Rs. 102 /- per Registration tablet/ Pack of Board. 14’s & 30’s
M/s Fynk Pharma, Lahore:
The following products of M/s Fynk Pharma, Lahore, were deferred in the 242nd meeting due to non availability of formulation in reference authorities. Now the firm has submitted that they have mistakenly submitted the wrong strength and requested to consider fresh submitted application with new fee & correct strength.
FATID Dry powder Form 5 Acdrol Deferred for Rejected suspension Fast Track (Pharmapak) confirmation of international Each 5ml contains:- Pack of 60 ml USP availability in SRA Famotidine USP 10mg bottle 28.5.2013, Antihistaminic 570/Rs60000
USP Specifications As per PRC
314. FATID Dry powder Form 5 FDA. Pepcid Approved in suspension 40mg/5ml by lieu of 17-03-2016 M/s Salix rejected Each 5ml contains:- vide diary No. Pharma application Famotidine USP 40mg 329 Rs.20,000 as per Zepsin decision of Antihistaminic As per SRO 40mg/5ml by 250th M/s Cirin Registration USP Specifications board Firm is GMP meeting compliant as per inspection dated 01-12-2014 by area FID.
Minutes for 257th Registration Board Meeting 138
Evaluator II: Ahsan Ul Haq Athar
S/N Name and Brand Name Type of Form Reason for which Decision address of (Proprietary name + Dosage Form Deferred. manufacturer / + Strength) Initial date, diary Applicant Composition Fee including differential fee Pharmacological Group Demanded Price Finished product Specification / Pack size
315. M/s ATCO Oraxib Form-5 Arcoxia Deferred for Laboratories Tablet Dy. No: 1312 (Grunenthal) confirmation of Limited, B-18 Each film coated tablet contains: dated. MHRA me too status. SITE Karachi. Etoricoxib MS ……… 30mg 02.08.2012 (1817) Anti arthritis Rs.8,000/- Me too in same (Atco specification) 02.08.2013 strength not Rs:12,000/- confirm Rs. 35/Tablet 2’s, 5’s, 7’s, 10’s, 14’s, 20’s, 28’s, 30’s 316. -do- Oraxib Form-5 Arcoxia Approved (1815) Tablet Dy. No: 1311 (Grunenthal) Each film coated tablet contains: dated. MHRA Etoricoxib MS ……… 60mg 02.08.2012 Anti arthritis Rs.8,000/- Etoricoxib (OBS (Atco specification) 02.08.2013 Healthcare) Rs:12,000/- Rs. 70/Tablet 2’s, 5’s, 7’s, 10’s, 14’s, 20’s, 28’s, 30’s 317. -do- Oraxib Form-5 Arcoxia Deferred for (1800) Tablet Dy. No: 1333 (Grunenthal) confirmation of Each film coated tablet contains: dated. MHRA me too status. Etoricoxib MS ……… 90mg 20.07.2012 Anti arthritis Rs.8,000/- Me too in same (Atco specification) 02.08.2013 strength not Rs:12,000/- confirm Rs. 105/Tablet 2’s, 5’s, 7’s, 10’s,
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14’s, 20’s, 28’s, 30’s 318. -do- Oraxib Form-5 Arcoxia Deferred for (1816) Tablet Dy. No: 1318 (Grunenthal) confirmation of Each film coated tablet contains: dated. MHRA me too status. Etoricoxib MS ……… 120mg 02.08.2012 Anti arthritis Rs.8,000/- Me too in same (Atco specification) 02.08.2013 strength not Rs:12,000/- confirm Rs. 140/Tablet 2’s, 5’s, 7’s, 10’s, 14’s, 20’s, 28’s, 30’s 319. -do- Alodip H 300/10/25mg Form-5-D Amturnide Deferred for the (2466) Tablet Dy. No: 487 (Novartis) submission of Each film coated tablet contains: dated. USFDA stability data as Aliskiren as (hemifumarate) 31.03.2011 per 251st MS……… 300mg Rs.15,000/- meeting of RB. Hydrochlorothiazide USP … 02.08.2013 25mg Rs.35,000/- Amlodipine (besylate)…..10mg Rs. 3080/14’s (Cardiovascular drugs) 6160/28’s (Atco specification) 320. -do- Dioplus-H Tablet 5/80/12.5 Form-5 Deferred for (796) Tablet Dy. No: 258 submission of Each film coated tablet contains: dated. 18-10- approval status Amlodipine besylate BP eq. to 2011 of same Amlodipine……5mg Rs.8,000/- formulation by reference Valsartan USP………80mg Dated.02-08- regulatory Hydrochlorothiazide 2013 authorities and USP…...12.5mg Rs.12,000/- me too status (Antihypertensive combination) Rs.60/Tablet 14’s 321. -do- Malquin Form-5-D Deferred for the (1802) Tablet Dy. No: 1256 submission of Each tablet contains: dated. stability data as Arterolane MS ……… 150mg 24.07.2012 per 251st Piperaquine Phosphate MS …… Rs.15,000/- meeting of RB. 750 02.08.2013 (Atco specification) Rs.35,000/- (Antimalerial) Rs. 200/Tablet 200’s, 6’s, 12’s 322. -do- Pitastin Form-5 Livalo (Kowa Co) Approved (1833) Tablet Dy. No: 1343 USFDA Each film coated tablet contains: dated. Pitavastatin Calcium MS eq to 07.08.2012 Pitalo (Genix)
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Pitavastatin ……… 4mg Rs.8,000/- Hypolipedemic Differential fee (Atco specification) Challan not attached Rs. 150/Tablet 10’s, 30’s 323. -do- Pitastin Form-5 Livalo (Kowa Co) Approved (1834) Tablet Dy. No: 1342 USFDA Each film coated tablet contains: dated. Pitavastatin Calcium MS eq to 07.08.2012 Pitalo (Genix) Pitavastatin ……… 2mg Rs.8,000/- Hypolipedemic Differential fee (Atco specification) Challan not attached Rs. 90/Tablet 10’s, 30’s 324. -do- Pitastin Form-5 Livalo (Kowa Co) Approved (1832) Tablet Dy. No: 1341 USFDA Each film coated tablet contains: dated. Pitavastatin Calcium MS eq to 07.08.2012 Pitalo (Genix) Pitavastatin ……… 1mg Rs.8,000/- Hypolipedemic Differential fee (Atco specification) Challan not attached Rs. 55/Tablet 10’s, 30’s 325. -do- Paracol Form-5-D Deferred for (1801) Tablet Dy. No: 1254 submission of Each film coated tablet contains: dated. approval status Thiocolchicoside MS ……… 24.07.2012 of same 8mg Rs.15,000/- formulation by reference Aceclofenac BP ………. 100mg 02.08.2013 regulatory Paracetamol ………. 500mg Rs.35,000/- authorities Muscle Relaxant Rs. 180/Tablet (Atco specification) 7’s, 14’s, 28’s
326. -do- Paracol Form-5-D Deferred for (1803) Tablet Dy. No: 1255 submission of Each film coated tablet contains: dated. approval status Thiocolchicoside MS ……… 24.07.2012 of same 4mg Rs.15,000/- formulation by reference Aceclofenac BP ………. 100mg 02.08.2013 regulatory Paracetamol ………. 500mg Rs.35,000/- authorities Muscle Relaxant Rs. 90/Tablet (Atco specification) 7’s, 14’s, 28’s
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327. -do- Phenobarb Form-5 Phenobarbital Deferred for (1541) Tablet Dy. No: 447 Tablets (Actavis, submission of Each tablet contains: dated. UK) MHRA approval status Phenobarbital USP ……… 60mg 17.04.2012 of same Anti epileptic Rs.8,000/- formulation in Pakistan and (USP specification) 02.08.2013 segregated Rs.12,000/- facility for Rs. 24/Tablet psychotropic 14’s, 30’s manufcaturing. 328. -do- Phenobarb Form-5 Phenobarbital Deferred for (1540) Tablet Dy. No: 446 Tablets (Actavis, segregated Each tablet contains: dated. UK) MHRA facility for Phenobarbital USP ……… 30mg 17.04.2012 psychotropic Anti epileptic Rs.8,000/- Phenobarbitone manufcaturing (USP specification) 02.08.2013 Tablets Rs.12,000/- (Ferozsons) Rs. 12/Tablet 14’s, 30’s 329. -do- Azitan Plus 40/12.5 Form-5-D Edarbyclor Deferred for (1750) Tablet Dy. No: 1109 (Takeda Pharms) stability data as st Each film coated tablet contains: dated. USFDA per 251 Azilsartan medoxiomil as 26.06.2012 meeting. Azilsartan Kamedoxomil MS Rs.15,000/-
…….40mg 02.08.2013 Chlorthalidon USP ……… Rs.35,000/- 12.5mg Rs. 2,000/Tablet Anti Hypertensive 7’s, 14’s, 28’s (ATCO specification)
330. -do- Azitan Plus 40/25 Form-5-D Edarbyclor Deferred for (1751) Tablet Dy. No: 1110 (Takeda Pharms) stability data as st Each film coated tablet contains: dated. USFDA per 251 Azilsartan medoxiomil as 26.06.2012 meeting. Azilsartan Kamedoxomil MS Rs.15,000/-
…….40mg 02.08.2013 Chlorthalidon USP ……… 25mg Rs.35,000/- Anti Hypertensive Rs. 2,200/Tablet (ATCO specification) 7’s, 14’s, 28’s
331. -do- Azitan Form-5-D Deferred for (1768) Tablet Dy. No: 1331 confirmation of Each tablet contains: dated. approval status Azilsartan medoxiomil as 28.06.2012 of same Azilsartan Kamedoxomil MS Rs.15,000/- formulation by reference ……….…. 20mg 02.08.2013 regulatory Anti Hypertensive Rs.35,000/- authorities.
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(ATCO specification) Rs. 600/Tablet 7’s, 14’s, 28’s 332. -do- Azitan Form-5-D Deferred for (1749) Tablet Dy. No: 1108 confirmation of Each tablet contains: dated. approval status Azilsartan medoxiomil as 26.06.2012 of same Azilsartan Kamedoxomil MS Rs.15,000/- formulation by reference ……….…. 80mg 02.08.2013 regulatory Anti Hypertensive Rs.35,000/- authorities. (ATCO specification) Rs. 2,100/Tablet 7’s, 14’s, 28’s 333. -do- Altaq Form-5-D Multaq (Sanofi Deferred for (1680) Tablet Dy. No: 917 Aventis US) stability data as st Each tablet contains: dated. USFDA per 251 Dronedarone HCl MS eq to 07.06.2012 meeting. Dronedarone ……….…. 400mg Rs.15,000/- Anti Arrhythamic 02.08.2013 (ATCO specification) Rs.35,000/- Rs. 425/Tablet 14’s, 28’s 334. -do- Melati 25mg Form-5-D Deferred for (1701) Tablet Dy. No: 1013 submission of Each film coated tablet contains: dated. approval status Agomelatine MS ……….…. 12.06.2012 of same 25mg Rs.15,000/- formulation by reference Anti Depressant Differential fee regulatory (ATCO specification) Challan not authorities attached Rs. 175/Tablet 7’s, 14’s, 28’s 335. -do- Combinol C&C Junior Form-5-D Deferred for (1702) Syrup Dy. No: 1014 submission of Each 5ml contains: dated. approval status Dextromethophan HBr BP 12.06.2012 of same ………….…. 5mg Rs.15,000/- formulation by reference Promethazine HCl BP …..1.5mg 02.08.2013 regulatory Cold & Cough Preparation Rs.35,000/- authorities (ATCO specification) Rs. 60/60ml 336. -do- Combinol C&C Form-5-D Deferred for (1594) Syrup Dy. No: 740 submission of Each 5ml contains: dated. approval status Dextromethophan HBr BP 17.05.2012 of same ………….…. 10mg Rs.15,000/- formulation by reference Salbutamol sulphate BP Eq to 02.08.2013 regulatory Salbutamol ……… 1mg Rs.35,000/- authorities Chlorpheniramine Maleate BP Rs. 80/120ml
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…………….. 4mg Terpin Hydrate USP ….. 3.5mg Ammonium Chloride BP …… 90mg Cold & Cough Preparation (ATCO specification)
337. -do- Nonit 1% Form-5-D Deferred for (1738) Topical solution Dy. No: 1063 submission of Each gm contains: dated. approval status Ivermectin ………….…. 10mg 19.06.2012 of same (1%w/v) Rs.15,000/- formulation by reference Anti Lice 02.08.2013 regulatory (USP specification) Rs.35,000/- authorities Rs. 300/30ml 600/60ml 800/120ml 338. -do- Scabion Plus Form-5-D Deferred for (1703) Lotion Dy. No: 1019 submission of Each Pack contains: dated. approval status Crotamiton BP …………. 13.06.2012 of same 10%w/v Rs.15,000/- formulation by reference Permethrin MS ………. 5%w/v 02.08.2013 regulatory Scabicidal @ Anti pruritis Rs.35,000/- authorities (ATCO specification) Rs. 300/60ml
339. -do- Nevol Form-5 Bystolic (Forest Approved (1952) Tablet Dy. No: 1344 Labs) USFDA Each tablet contains: dated. Nebivolol HCl MS eq. to 23.10.2012 Byscard (Searle) Nebivolol……2.5mg Rs.20,000/- (Anti hypertension) Rs.25/Tablet (Atco Specs) 10’s,14’s 340. -do- Nevol Form-5 Bystolic (Forest Approved (1953) Tablet Dy. No: 1345 Labs) USFDA Each tablet contains: dated. Nebivolol HCl MS eq. to 23.10.2012 Byscard (Searle) Nebivolol……10mg Rs.20,000/- (Anti hypertension) Rs.100/Tablet (Atco Specs) 10’s,14’s
341. -do- Vorinaz Form-5 Vfend (PF Prism Approved (1954) Tablet Dy. No: 1347 CV) USFDA Each film coated tablet contains: dated. Voriconazole MS……50mg 23.10.2012 Vorif (Ferozsons) (Anti fungal) Rs.20,000/-
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(Atco specs) Rs.100/Tablet 10’s,20’s 342. -do- Vorinaz Form-5 Vfend (PF Prism Approved (1951) Tablet Dy. No: 1346 CV) USFDA Each film coated tablet contains: dated. Voriconazole MS……200mg 23.10.2012 Vorif (Ferozsons) (Anti fungal) Rs.20,000/- (Atco specs) Rs.220/Tablet 10’s,20’s 343. -do- Alme Cream Form-5 D Emla (Oak Deferred for (1955) Cream Dy. No: 1348 Pharma) USFDA Stability studies st Each gm contains: dated. as per 251 Lidocaine USP……2.5%w/w 23.10.2012 meeting of RB Prilocaine USP…….2.5%w/w Rs.50,000/- (Local Anesthetic) Rs.100/5g USP Specs Rs.200/10 Rs.300/15g Rs.600/30g 344. -do- Epigran-125 Form-5 Dalantin-125 Approved (1442) Oral Suspension Dy. No: 592 (Parke davis) Each 5ml contains: dated. 29-11- Phenytoin USP…..125mg 2011 Dilantin (Pfizer) (Anti epileptic) Rs.8,000/- USP Specs 02.08.2013 Rs.12,000/- Rs.150/60ml, 300/120ml 345. -do- Floxin Dry Oral Suspension Form-5 Novidate (Sami) Rejected as per (1817) Oral Suspension Dy. No: 2319 formulation is Each 5ml contains: dated. 27-12- not approved by Ciprofloxacin HCl.…..125mg 2012 reference (Anti biotec) Rs.20,000/- regulatory authorities. Rs.125/30ml
Rs.250/60ml 346. -do- Aloglip 12.5mg Form-5-D Nesina (Takeda Deferred for (1973) Tablet Dy. No: 1973 Pharms) USFDA stability studies st Each film coated tablet contains: dated. 01-11- as per 251 Alogliptin Benzoate MS eq. to 2012 meeting. Alogliptin….12.5mg Rs.50,000/- (Antidiabetic) Rs.330/Tablet 10’s,14’20’s,30 347. -do- Aloglip 25mg Form-5-D Nesina (Takeda Deferred for (1974) Tablet Dy. No: 1972 Pharms) USFDA Stability studies st Each film coated tablet contains: dated. 01-11- as per 251 Alogliptin Benzoate MS eq. to 2012 meeting. Alogliptin….25mg Rs.50,000/-
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(Antidiabetic) Rs.500/Tablet 10’s,14’20’s,30 348. -do- Aloglip 6.25mg Form-5-D Nesina (Takeda Deferred for (1972) Tablet Dy. No: 1974 Pharms) USFDA Stability studies st Each film coated tablet contains: dated. 01-11- as per 251 Alogliptin Benzoate MS eq. to 2012 meeting. Alogliptin….6.25mg Rs.50,000/- (Antidiabetic) Rs.165/Tablet 10’s,14’20’s,30 349. -do- Epigran Tablet 100mg Form-5 Phenytoin Approved (1930) Tablet Dy. No: 506 (Aurobindo Each film coated tablet contains: dated. 15-11- Pharm) MHRA Phenytoin Sodium USP…100mg 2011 (Anti Epileptic) Rs.8,000/- Epitoin (Adamjee) Dated.02-08- 2013 Rs.12,000/- Rs.10/Tablet 30’s,100’s 350. -do- Nevol Form-5 Bystolic (Forest Approved (1970) Tablet Dy. No: 1969 Labs) USFDA Each tablet contains: dated. 01-11- Nebivolol HCl Ms eq. to 2012 Byscard (Searle) Nebivolol…..5mg Rs.20,000/- (Antihypertension) Rs.50/Tablet (Atco Specs) 10’s,14’s 351. -do- Nevol Form-5 Bystolic (Forest Deferred for (1971) Tablet Dy. No: 1970 Labs) USFDA confirmation of Each tablet contains: dated. 01-11- me too status Nebivolol HCl Ms eq. to 2012 Me too not Nebivolol…..20mg Rs.20,000/- provided. (Antihypertension) Rs.200/Tablet (Atco Specs) 10’s,14’s 352. M/s Uniferoz Saniplast Aqua Bandage Form-5 BAND-AID Deferred for PVT. Ltd. 32/8 First Aid Bandage Dy. No: 1442 (Johnson & for clarification Sector 15, Each Bandage contains: Dated. Johnson) made in for registration Korangi Polyurethane (PU) Tape 21.06.2012 Brazile, of the same Industrial Area, Bezalkonium Chloride Pad Rs.8,000/- distributed in strength / composition. Karachi. ………………..0.5%w/w. Dated.05.09.2013 canada. (1840) (First Aid Bandage) Rs.12000/- Nexcare Clear by (Mfg. specs) Rs.41/10’s 3M consumer (25x72mm), Health Care USA. 40.50/10’s Saniplast Ultra (38x38mm) first aid Bandage 40.57/10’s, (with (5’s x25x72mm Poluethylene
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& 5’sx38x38mm) Base) by 40.57/20’s, M/sUniferoz. (10’s x25x72mm & 10’s x38x38mm) 353. M/s Paktex Pak optic Eye Pad Form-5 Rejected as firm Industries 2.5 Surgical Dressing Dy. No: 2438 does not have KM Tatly Road, Each Eye Pad contains: Dated. sterile facility Saroya Abad, Absorbent Cotton, Cloth 18.06.2011 Optic (Cotton Kamoki. (Surgical Dressing) Rs.8,000/- Craft) (1703) (……... specs) Dated.06.08.2013 Rs.12000/- Rs.580/(25x5cm X 7.5cm), Rs.850/(6cm X 8m),
354. M/s OBS Zerogout Form-5 Uloric (Takeda) Approved Pakistan (Pvt) Tablet Dy. No: 624 USFDA Ltd, C14 SITE Each film coated tablet contains: Dated. Karachi. Febuxostat……..40mg 22.12.2011 (1220) (Anti-gout preparation) Rs.8,000/- Adenuric (S.J &G (Obs specs) Dated.26.07.2013 Fazal Elahi) Rs.12000/- Rs.543/- 20’s, 355. -do- Zerogout Form-5 Uloric (Takeda) Approved (1221) Tablet Dy. No: 625 USFDA Each film coated tablet contains: Dated. Febuxostat……..80mg 22.12.2011 (Anti-gout preparation) Rs.8,000/- Adenuric (S.J &G (Obs specs) Dated.26.07.2013 Fazal Elahi) Rs.12000/- Rs.880/- 20’s, 356. -do- Allergia Form-5 Fexofenadine HCl Approved (1447) Tablet Dy. No: 1121 Hives (Teva) Each film coated tablet contains: Dated. USFDA Fexofenadine 28.05.2013 hydrochloride…….60mg Rs.20,000/- Fexet (Getz) (Antihistamine) Rs.178.82/- (Obs specs) 20’s, 357. -do- Allergia Form-5 Telfast (Sanofi) Approved (1582) Tablet Dy. No: 1120 USFDA Each film coated tablet contains: Dated. Fexofenadine 28.05.2013 Fexet (Getz)
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hydrochloride…….120mg Rs.20,000/- (Antihistamine) Rs.282.35/20’s, (Obs specs) 358. -do- Allergia Form-5 Telfast (Sanofi) Approved with (1583) Tablet Dy. No: 1122 USFDA change in brand Each film coated tablet contains: Dated. name Fexofenadine 28.05.2013 hydrochloride…….180mg Rs.20,000/- (Antihistamine) Rs.397.65/20’s, Fexet (Getz) (Obs specs) 359. -do- Obspride 50mg Form-5 Deferred as per (1584) Tablet Dy. No: 1507 250th meeting of Each film coated tablet contains: Dated. RB for Itopride hydrochloride…….50mg 05.08.2013 Ganaton (Abbott) confirmation of (Gastroprokinetic agent) Rs.20,000/- availability of this formulation (Obs specs) Rs.176.47/10’s, in PMDA Japan. 360. -do- Obspride 150mg Form-5 Rejected as the (1585) Tablet Dy. No: 1505 formulation is Each film coated tablet contains: Dated. not approved by Itopride 05.08.2013 Ganaton (Abbott) reference drug hydrochloride…….150mg Rs.20,000/- regulatory agencies. (Gastroprokinetic agent) Rs.388.24/10’s,
(Obs specs) 361. -do- Obzitic 200mg/100ml Form-5 Zyvox (Pharmacia Deferred for (1697) Solution for infusion Dy. No: 377 and Upjohn) confirmation of Each ml contains: Dated. infusion section Linezolid. …………. 2mg 21.10.2011 (Antibacterial agent) Rs.8,000/- Zolrest (Bosch) (Obs specs) Differential fee Challan not attached. Rs.407/100ml 471/200ml 706/300ml 362. -do- Obzitic 400mg/200ml Form-5 Zyvox (Pharmacia Deferred for (1698) Solution for infusion Dy. No: 376 and Upjohn) confirmation of Each ml contains: Dated. infusion section Linezolid. …………. 2mg 21.10.2011 (Antibacterial agent) Rs.8,000/- Zolrest (Bosch) (Obs specs) Differential fee Challan not attached. Rs.407/100ml 471/200ml 706/300ml 363. -do- Sleepill 1mg Form-5 Lunesta (Snovion Approved with
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(1822) Tablet Dy. No: 1158 Pharms INC.) change of name. Each tablet contains: Dated. USFDA Eszopiclone. …………. 1mg 03.06.2013 (Non Benzodiapepine, Hypnotic Rs.20,000/- Clonexa (Atco) agent) Rs.82.35/10’s (Obs specs) 364. -do- Sleepill 3mg Form-5 Lunesta (Snovion Approved with (1821) Tablet Dy. No: 1159 Pharms INC.) change of name Each tablet contains: Dated. USFDA Eszopiclone. …………. 3mg 03.06.2013 (Non Benzodiapepine, Hypnotic Rs.20,000/- Clonexa (Atco) agent) Rs.211.76/10’s (Obs specs) 365. -do- Nebicard 5mg Form-5 Bystolic (Forest Approved (1406) Tablet Dy. No: 1652 Labs) USFDA Each tablet contains: Dated. Nebivolol (as HCl)….5mg 29.08.2013 Byscard (Searle) (β- adrenergic receptor blocking Rs.20,000/- agent) Rs.190/- (Obs specs) 14’s, 366. -do- Nebicard 2.5mg Form-5 Bystolic (Forest Approved (1444) Tablet Dy. No: 1653 Labs) USFDA Each tablet contains: Dated. Nebivolol (as HCl)….2.5mg 29.08.2013 Byscard (Searle) (β- adrenergic receptor blocking Rs.20,000/- agent) Rs.113/- (Obs specs) 14’s, 367. -do- Nebicard 10mg Form-5 Bystolic (Forest Approved (1445) Tablet Dy. No: 1651 Labs) USFDA Each tablet contains: Dated. Nebivolol (as HCl)…..10mg 29.08.2013 Byscard (Searle) (β- adrenergic receptor blocking Rs.20,000/- agent) Rs.313/- (Obs specs) 14’s, 368. -do- Uricontrol 5mg Form-5 Vesicare Approved (1218) Tablet Dy. No: 626 (Astellas) USFDA Each film coated tablet contains: Dated. Solifenacin Succinate ……. 5mg 22.12.2011 Silifen (Getz) (Urinary incontinence Product) Rs.8,000/- (Obs specs) 26.07.2013 Rs.12,000/- Rs.459/- 10’s, 369. -do- Uricontrol 10mg Form-5 Vesicare Approved (1219) Tablet Dy. No: 627 (Astellas) USFDA Each film coated tablet contains: Dated.
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Solifenacin Succinate ……. 10mg 22.12.2011 Silifen (Getz) (Urinary incontinence Product) Rs.8,000/- (Obs specs) 26.07.2013 Rs.12,000/- Rs.800/- 10’s, 370. -do- Xalto 10mg Form-5 Xarelto (Janssen Approved (1446) Tablet Dy. No: 17 Pharms) USFDA Each film coated tablet contains: Dated. Rivaroxaban (micronized) 25.07.2011 Xrelto (Bayer …………….…. 10mg Rs.8,000/- Health Care) (Antithrombic Agent) 26.07.2013 (Obs specs) Rs.12,000/- Rs.7200/- 10’s, 371. M/s Sami Novoteph Insta 20mg Form-5 Rejected as Pharmaceuticals Tablet Dy. No: 208 formulation is (Pvt) Limited, F- Each film coated tablet contains: dated. not approved by 95, S.I.T.E. Esomeprazole Magnesium 18.05.2011 reference Karachi, Trihydrate eq. to Esomeprazole Rs.8,000/- regulatory authorities. Pakistan. ………. 20mg 24.07.2013 (1410) Sodium bicarbonate …….. Rs.12,000/- 1100mg Rs.910/14’s (Anti Ulcer, PPI) (Sami Specs) 372. M/s AGP Dexigesic 300mg Form-5 Seractil (Genus Approved with (Private) Tablet Dy. No: 175 Pharmaceuticals change of name Limited, B-23 Each film coated tablet contains: dated. UK) BNF-67 SITE Area Dexibuprofen …. 300mg 12.03.2011 Karachi. (Propionic Acid Derivatives) Rs.8,000/- Dexifen (ICI (917) (Mfg. Specs) 02.08.2013 Pakistan Limited) Rs.12,000/- Rs.265/30’s 373. -do- Dexigesic 100mg/5ml Form-5 Deferred for (914) Oral suspension Dy. No: 176 Dexib (Tabros) approval status Each 5ml contains: Dated. in reference Dexibuprofen …. 100mg 12.03.2011 countries. (Propionic Acid Derivatives) Rs.8,000/- (Mfg. Specs) 02.08.2013 Rs.12,000/- Rs. 53/60ml 100/120ml 374. -do- Rubifer-F Form-5 Deferred for (1285) syrup Dy. No: 66 approval status Each 5ml contains: Dated. in reference Iron (III) Hydroxide Polymaltose 04.08.2011 countries and Pakisatn.
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Complex eq to elemental iron Rs.8,000/- ………….…. 100mg 02.08.2013 Folic Acid …….0.35mg Rs.12,000/- (Hematinic) Rs. 140/60ml (Mfg. Specs) 265/120ml 375. -do- Nitazox 500mg Form-5 Alina (Romark) Approved (1474) Tablet Dy. No: 61 USFDA Each film coated tablet contains: dated. Nitazoxanide ……….. 500mg 20.01.2012 Atizox (Macter) (antiprotozoal) Rs.8,000/- (Mfg. Specs) 02.08.2013 Rs.12,000/- Rs.235/20’s 376. -do- Urso plus Form-5-D Not Provided Rejected as (2014) Capsule Dy. No: 2169 formulation is Each capsule contains: dated. not approved by Ursodeoxycholic Acid….. 250mg 26.11.2012 reference Silymarin Rs.50,000/- regulatory authorities. …………………140mg Rs.700/10’s (Bile & Liver Therapy) (Mfg. Specs) Indications:- it is indicated for cholestatic liver diseases, Non alcoholic steatohepatitis, Chronic Hepatitis C, hepatocellular Carcinoma. 377. -do- Diacerein 50mg Form-5 Not Provided Deferred as (1909) Capsule Dy. No: 1256 product is under Each capsule contains: dated. Rein (S.J.& G review / expert Diacerein….. 50mg 15.10.2012 Fazul ellahie) opinion (Anti-inflamatory and anti Rs.20,000/- rheumatic Rs.850/30’s (Mfg. Specs) 378. -do- Cinpride 1mg Form-5 Deferred for (1420) Tablet Dy. No: 507 Cinita (Getz) confirmation od Each film coated tablet contains: dated. approval status Cinitapride hydrogen tartarate eq 15.11.2011 by reference to cinitapride …. 1mg Rs.8,000/- regulatory authorities. (antiemetic) 02.08.2013 (Mfg. Specs) Rs.12,000/- Rs.255/10’s 379. -do- Biorex 20mg Form-5 Cheisi Approved (1836) Tablet Dy. No: 1374 farmaceutica Each tablet contains: dated. importing Brexin Piroxicam β Cyclodextrin …… 13.08.2012 Tablets from Italy 20mg Rs.8,000/-
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(NSAID) Differential fee Betadex (Kaizen) (Mfg Specs) Challan not attached Rs.183.75/20’s 380. -do- Nervit 500mcg Form-5 Approved with (1285) Tablet Dy. No: 1446 Methycobal change of name Each film coated tablet contains: dated. (Hilton) Mecobalamin …….500mcg 06.05.2011 (Vit B12 Coenzyme) Rs.8,000/- (Mfg. specs) Differential fee Challan not attached Rs.600/100’s 381. -do- Furic 40mg Form-5 Uloric (Takeda) Approved (1739) Tablet Dy. No: 1053 USFDA Each film coated tablet contains: dated. Febuxostate …… 40mg 18.06.2012 (anti Hyperuricemic Agent) Rs.8,000/- Adenuric (S.J &G (Mfg. specs) 02.08.2013 Fazal Elahi) Rs.12,000/- Rs.518/20’s 382. -do- Furic 80mg Form-5 Uloric (Takeda) Approved (1740) Tablet Dy. No: 1195 USFDA Each film coated tablet contains: dated. Febuxostate …… 80mg 19.06.2012 (anti Hyperuricemic Agent) Rs.8,000/- Adenuric (S.J &G (Mfg. specs) Differential fee Fazal Elahi) Challan not attached Rs.840/20’s 383. -do- Urgex 5mg Form-5 Vesicare Approved (1497) Tablet Dy. No: 215 (Astellas) USFDA Each film coated tablet contains: dated. Solifenacin Succinate …… 5mg 10.02.2012 Silifen (Getz) (urinary antispasmodic) Rs.8,000/- P.522 (Mfg. specs) 02.08.2013 Rs.12,000/- Rs.450/10’s 384. -do- Urgex 10mg Form-5 Vesicare Approved (1498) Tablet Dy. No: 214 (Astellas) USFDA Each tablet contains: dated. Solifenacin Succinate …… 10mg 10.02.2012 Silifen (Getz) (urinary antispasmodic) Rs.8,000/- P.522 (Mfg. specs) 02.08.2013 Rs.12,000/- Rs.700/10’s
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385. -do- Loxifast 4mg Form-5 Approved (1477) Tablet Dy. No: 63 Noxflam (Genix) Each film coated tablet contains: dated. Lornoxicam …… 4mg 23.01.2012 (NDAID) Rs.8,000/- (Mfg. specs) 02.08.2-13 Rs.12,000/- Rs.80/10’s 386. -do- Loxifast 8mg Form-5 EMA approved Approved (1478) Tablet Dy. No: 62 Nycomed 8mg Each film coated tablet contains: dated. tablet (Denmark) Lornoxicam …… 8mg 23.01.2012 (NDAID) Rs.8,000/- Noxflam (Genix) (Mfg. specs) 02.08.2-13 Rs.12,000/- Rs.140/10’s 387. Toll Axid Neo 40mg (IV infusion) Form-5 Nexium Rejected as M/s Manufacturing Injection Dy. No: 492 (Astrazenica) BF Biosciences M/s AGP Each vial contains: dated. USFDA doesn’t possess (Private) Esomeprazole Sodium eq to 31.03.2011 manufacturing Limited, B-23 Esomeprazole …. 40mg Rs.8,000/- E-Z (English) facility. SITE Area (PPI) 02.08.2013 Karachi. (……….SPECS) Rs.12,000/- (950) Rs.300/30’s
Toll Manufacturer M/s BioSciences Limited Lahore. 388. M/s S.J. & G. Epigo 100mg Form-5 Phenytoin Approved Fazul Ellahie Tablet Dy. No: 109 (Aurobindo (Pvt.) Ltd, Each film coated tablet contains: Dated. Pharm) MHRA Karachi. Phenytoin Sodium …. 100mg 24.08.2011 (1311) (Anti epileptic) Rs.8,000/- Epitoin (Adamjee) (BP specs) 04.09.2013 Rs.12,000/- Rs.35/20’s 160/100’s 389. -do- Epigo 100mg Form-5 Dilantin (Pfizer Approved (1305) Capsule Dy. No: 026 USA) Each capsule contains: Dated. Phenytoin Sodium …. 100mg 29.08.2011 (Anti epileptic) Rs.8,000/- Dilantin (Pfizer) (BP specs) 04.09.2013 Rs.12,000/- Rs.50/20’s
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240/100’s 390. -do- Epigo 30mg/5ml Form-5 Epanutin (Pfizer) Approved (1310) Suspension Dy. No: 105 MHRA Each 5ml contains: Dated. Phenytoin …. 30mg 29.08.2011 Epitoin (Adamjee) (Anti epileptic) Rs.8,000/- (BP specs) 04.09.2013 Rs.12,000/- Rs.50/20’s 240/100’s 391. -do- Epigo 250mg Form-5 Phenytoin Sodium Approved (1302) Injection Dy. No: 107 (Amdipharm Each 5ml contains: Dated. Mercury Phenytoin sodium…. 250mg 29.08.2011 Company) MHRA (Anti epileptic) Rs.8,000/- (BP specs) 04.09.2013 Epigran (Atco) Rs.12,000/- Rs.250/5x5’s 392. -do- Mefnate 300/750mg Form-5 Artequin (Mepha Approved as the Tablets Dy. No: 115 Ltd. Switzerland) firm has co- Each co-blister Tablets contains: Dated. blister facility as Artesunate …. 100mg (3 tablets) 22.08.2011 Artiking (Maple per inspection Mefloquine HCl eq. to Rs.8,000/- Pharma) in 237th report dated 20- 08-2011 by area Mefloquine …….. 250 (3 Tablets) 28.08.2013 meeting on WHO FID. (Anti Malarial) Rs.12,000/- recommendation. (S.J.G. specs) Rs.780/Pack (6’s) 393. -do- Fextral 20mcg/ml Form-5 Deferred for Suspension Dy. No: 113 approval status Each ml contains: Dated. in reference Formoterol Fumarate Dihydrate 22.08.2011 Easair (Platinum) countries. eq. to Formoterol Fumarate Rs.8,000/- ………… 20mcg 28.08.2013 (Anti asthmatic) Rs.12,000/- (S.J.G. specs) Rs.50/20’s 240/100’s 394. M/s MBL Zincbar Form-5 WHO/ UNICEF Approved Pharma, Plot No. Syrup Dy. No: 92 recommendation B-77/A, Hub Each 5ml contains: Dated. is for zinc Industrial Trade Elemental zinc (as Zinc Sulphate 14.02.2011 sulphate 10mg/5 Estate Monohydrate) …. 10mg Rs.8,000/- ml solution. Baluchistan. (Antidiarrhoeals) 05.08.2013 (Ref.250th RB (868) (USP specs) Rs.12,000/- meeting ) Rs.50/60ml Zegen (Genera)
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395. -do- Polymazol Form-5 Approved (911) Tablets Dy. No: 162 Each Tablet contains: Dated. Iron (III) Hydroxide Polymaltose 12.03.2011 Complex eq to elemental Iron Rs.8,000/- Apofer (Platinum) …………………… 100mg 05.08.2013 (Haematanic) Rs.12,000/- (MBL specs) Rs.75/10’s 396. -do- Polymazol Form-5 RB has already Approved (910) Syrup Dy. No: 163 approved in 255th Each 5ml contains: Dated. meeting. Iron (III) Hydroxide Polymaltose 12.03.2011 Complex eq to elemental Iron Rs.8,000/- Apofer (Platinum) …………………… 50mg 05.08.2013 (Haematanic) Rs.12,000/- (MBL specs) attached. Rs.80/60ml 397. -do- Xumisol 40mg Form-5 Emozul 40 mg Approved (870) Each Capsule contains: Dy. No: 94 capsule by M/s Consilient UK Esomeprazole magnesium Dated. trihydrate pallets eq to 14.02.2011 Esso 40mg Esomeprazole …….. 40mg Rs.8,000/- (shaigan) (PPI) 05.08.2013 (MBL specs) Rs.12,000/- 08.03.2016 Sourse:- Qualitek Pharma, Plot Rs.80,000/- No 115, Phase V, IDA Doolapally Rs.275/14’s Village, Qutubullapur (Madl), Hyderabad-55, ANDHRAPRADESH, INDIA. 398. -do- Painowin 50mg Form-5 Caflam (Novartis) Approved with (1534) Tablets Dy. No: 391 USFDA change of name Each sugar coated Tablet Dated. contains: 16.04.2012 Caflam (Novartis) Diclofenac Potassium…… 50mg Rs.8,000/- (Anti-rheumatic) D05.08.2013 (USP specs) Rs.12,000/- Rs.110/20’s 399. -do- Astin DS 80/480 Form-5 Approved (1558) Tablets Dy. No: 533 ARCEVA Each Tablet contains: Dated. M/s Sami Artemether ….. 80mg 26.04.2012 Lumefantrine …… 480mg Rs.8,000/- (Anti-malarial) 05.08.2013 (USP specs) Rs.12,000/- Rs.310/20’s
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400. -do- Montil 10mg Form-5 BNF 10mg film Approved (1535) Tablets Dy. No: 388 coated tablet Each film coated Tablet contains: Dated. Montelukast sodium eq to 16.04.2012 Aerokast 10mg by Montelukast sodium…… 10mg Rs.8,000/- M/s Barrett (Anti-asthmatic) 05.08.2013 Hodgson (MBL specs) Rs.12,000/- Rs.250/2x7’s 401. -do- Alfox 0.5mcg Form-5 Bon One Martin Approved (1548) Tablets Dy. No: 536 Dow importing Each Tablet contains: Dated. from Teijen Japan Alfacalcidol ….…… 0.5mcg 26.04.2012 (Vitamin D analogue) Rs.8,000/- Adela (Getz) (MBL specs) 05.08.2013 Rs.12,000/- Rs.145/10’s 402. -do- Viospan 200mg Form-5 Suprax (Sanofi) Approved (867) Tablets Dy. No: 95 Each Tablet contains: Dated. Glixim (Getz) Cefixime USP ….…… 200mg 14.02.2011 (Cephalosporin) Rs.8,000/- (USP specs) 05.08.2013 Rs.12,000/- Rs.180/10’s 403. -do- Gluco 500/400mg Form-5 Deferred for (912) Tablets Dy. No: 161 confirmation of Each Tablet contains: Dated. approval status Glucosamin Sulphate.…… 12.03.2011 Gevolox (Hilton) by reference 500mg Rs.8,000/- regulatory authorities Chondroitin Sulphate 05.08.2013 …….400mg Rs.12,000/- (Anti-inflammatory & Rs.300/20’s Antiosteoarthritis) (USP specs) 404. -do- Kanz Dry Suspension 125mg/5ml Form-5 Rejected as the (1559) Suspension Dy. No: 534 formulation is not approved by Each 5ml reconstituted Dated. reference drug suspension contains: 07.04.2012 Novidate (Sami) regulatory Ciprofloxacin HCl eq to Rs.8,000/- agencies in such Ciprofloxacin ….…… 05.08.2013 formuation 125mg/5ml Rs.12,000/- (Quinolones) Rs.85/60ml (MBL specs) 405. M/s Amlo-V Plus Plus 5/160/25 Form-5 Exforge HCT Approved AsianContinental Tablet Dy. No: 1345 (Novartis (pvt) Ltd D-32, Each film coated tablet contains: dated. Pharmaceuticals
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Super Highway, Amlodipine (Besylate) …. 5mg 07.08.2012 Corp. US) SITE Karachi. Valsartan … 160mg Rs.8,000/- USFDA (1830) Hydrochlorothiazide …25mg 31.07.2013 (Angiotensin II antagonist + R.12,000/- Exforge HCT Calcium channel blocker + Rs. As per PRC (Novartis Pharma Thiazide diuretic) 14’s Pakistan Ltd) (Manufacturer specification) p.413
406. -do- Amlo-V Plus 10/160/12.5 Form-5 Exforge HCT Approved (1826) Tablet Dy. No: 1350 (Novartis Each film coated tablet contains: dated. Pharmaceuticals Amlodipine (Besylate) …. 10mg 07.08.2012 Corp. US) Valsartan … 160mg Rs.8,000/- USFDA Hydrochlorothiazide … 12.5mg 31.07.2013 (Angiotensin II antagonist + R.12,000/- Exforge HCT Calcium channel blocker + Rs. As per PRC (Novartis Pharma Thiazide diuretic) 14’s Pakistan Ltd) (Manufacturer specification) p.413
407. -do- Amlo-V Plus 10/160/25 Form-5 Exforge HCT Approved (1823) Tablet Dy. No: 1346 (Novartis Each film coated tablet contains: dated. Pharmaceuticals Amlodipine (Besylate) …. 10mg 02.08.2012 Corp. US) Valsartan … 160mg Rs.8,000/- USFDA Hydrochlorothiazide …25mg 31.07.2013 (Angiotensin II antagonist + R.12,000/- Exforge HCT Calcium channel blocker + Rs. As per PRC (Novartis Pharma Thiazide diuretic) 14’s Pakistan Ltd) (Manufacturer specification) p.413
408. -do- Amlo-V Plus 5/160/12.5 Form-5 Exforge HCT Approved (1824) Tablet Dy. No: 1349 (Novartis Each film coated tablet contains: dated. Pharmaceuticals Amlodipine (Besylate) …. 5mg 07.08.2012 Corp. US) Valsartan … 160mg Rs.8,000/- USFDA Hydrochlorothiazide … 12.5mg 31.07.2013 (Angiotensin II antagonist + R.12,000/- Exforge HCT Calcium channel blocker + Rs. As per PRC (Novartis Pharma Thiazide diuretic) 14’s Pakistan Ltd) (Manufacturer specification) p.413
409. -do- Amlo-V Form-5 Exforge (Novartis Approved (1828) Tablet Dy. No: 1347 Pharmaceuticals Each film coated tablet contains: dated. Corp. US) Amlodipine (Besylate) …. 10mg 07.08.2012 Valsartan ………………… Rs.8,000/- Amstan (Getz
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160mg 31.07.2013 Pharma Pakistan (Angiotensin II antagonist + R.12,000/- (Pvt.) Ltd) p.412 Calcium channel blocker) Rs. As per PRC (Manufacturer specification) 14’s 410. -do- Xacin Dry Suspension Form-5 Rejected as the (1600) 125mg/5ml Dy. No: 921 formulation is Suspension Dated. not approved Each 5ml contains: 09.06.2012 by reference Ciprofloxacin HCl eq to Rs.8,000/- Novidate (Sami) drug regulatory Ciprofloxacin ….…… 31.07.2013 agencies in 125mg/5ml R.12,000/- such (Quinolones) Rs. As per PRC formuation (Mfg. Specs) 60ml 411. M/s W. Dexrufen 100mg/5ml Form-5 Deferred for Woodward Oral suspension Dy. No: 1138 confirmation of Pakistan (pvt) Each 5ml contains: Dated. approval status Ltd. F-257 Dexibuprofen M.S. …. 100mg 29.06.2012 Dexib (Tabros) by reference S.I.T.E. Karachi (NSAIDs) Rs.8,000/- regulatory authorities (1761) (Mfg. Specs) 19.08.2013 Rs.12,000/- Rs. 50/60ml 412. -do- Dexrufen 400mg Form-5 Seractil (Genus Approved (1762) Tablet Dy. No: 1136 Pharmaceuticals Each Tablet contains: Dated. UK) BNF-67 Dexibuprofen M.S. …. 400mg 29.06.2012 (NSAIDs) Rs.8,000/- Dexifen (ICI (Mfg. Specs) 19.08.2013 Pakistan Limited) Rs.12,000/- p.846 Rs. 328/30’s 413. -do- Dexrufen 300mg Form-5 Seractil (Genus Approved (1763) Tablet Dy. No: 1142 Pharmaceuticals Each Tablet contains: Dated. UK) BNF-67 Dexibuprofen M.S. …. 300mg 29.06.2012 (NSAIDs) Rs.8,000/- Dexifen (ICI (Mfg. Specs) 19.08.2013 Pakistan Limited) Rs.12,000/- p.846 Rs. 265/30’s 414. -do- Artelum DS 30/180mg Form-5 Co-Artesiane Approved (1764) Oral suspension Dy. No: 1143 Suspension Each 5ml contains: Dated. (Slachthuisstraat, Artemether M.S. …..…. 30mg 29.06.2012 Belgium) Lumefantrine M.S. ……..180mg Rs.8,000/- (Anti Malarial) 19.08.2013 Gen-M DS (Mfg. Specs) Rs.12,000/- Suspension Rs. 150/30ml (Genix) 415. M/s Wellborne Lamogen 25mg Form-5 Lamictal Deferred for
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Pharmachem & Tablet Dy. No: 202 (Glaxosmith- confirmation Biologicals Plot Each film coated tablet contains: dated. kaline LLC) whether product No 51/1, 52/2 Lamotrigine ………. 25mg 08.05.2014 USFDA, MHRA is coated or Phase I-II (Anticonvulsant and antiepileptic) Rs.20,000/- otherwise Industrial estate (BP Specification) Rs. As fixed by Lamictal Hattar-Pakistan. Govt. (Glaxosmith- (1653) 3x10’s kaline) 416. -do- Lamogen 50mg Form-5 Lamictal Deferred for (1654) Tablet Dy. No: 199 (Glaxosmith- confirmation Each film coated tablet contains: dated. kaline LLC) whether product Lamotrigine ………. 50mg 08.05.2014 USFDA, MHRA is coated or (Anticonvulsant and antiepileptic) Rs.20,000/- otherwise (BP Specification) Rs. As fixed by Lamictal Govt. (Glaxosmith- 3x10’s kaline) 417. -do- Lycopirin 75mg Form-5 Boots Aspirine Deferred for (1657) Tablet Dy. No: 201 75mg dispersible confirmation of Each dispersible tablet contains: dated. Tablets (the local availability Aspirin ………. 75mg 08.05.2014 Boots Company in dispersable (Analgesics, antipyretics) Rs.20,000/- PLC) MHRA form (USP Specification) Rs. As fixed by Govt. Ascard (Atco 3x10’s Laboratories) 418. -do- Relaxa 2mg Form-5 Zanaflex by m/s Approved (1667) Tablet Dy. No: 191 cephalon. Each tablet contains: dated. (MHRA, US Tizanidine HCl ….…2mg 08-05-2014 FDA) (skeletal muscle relaxant) Rs.20,000/- (USP Specs.) Rs. As fixed by Govt. Musidin by m/s 1x10’s martin dow Pakistan limited. 419. -do- Relaxa 4mg Form-5 Zanaflex by m/s Approved (1668) Tablet Dy. No: 192 cephalon. Each tablet contains: dated. (MHRA, US Tizanidine HCl ….…4mg 08-05-2014 FDA) (skeletal muscle relaxant) Rs.20,000/- (Manufacturer Specs.) Rs. As fixed by Govt. Musidin by m/s 1x10’s martin dow Pakistan limited. 420. -do- Feforn Plus Form-5 ……… Approved. (1659) Tablet Dy. No: 200 Each chewable Tablet contains: Dated. Addfer-F (Atco Iron (III) Hydoxide Polymaltose 08.05.2014 Lab.) Complex eq to elemental Iron Rs.20,000/-
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…….…. 100mg Rs. As fixed by Folic Acid …….… 0.35mg Govt. (Haematinic) 2x10’s. (Manufacturer Specs.) 421. -do- Rifax 200mg Form-5 Xifaxanta 200 Approved (1666) Tablet Dy. No: 193 (Norgine Limited) Each film coated Tablet contains: Dated. MHRA Rifaximin …….…. 200mg 08.05.2014 (Semisynthe antibiotic) Rs.20,000/- Nimixa (Getz) (Manufacturer Specs.) Rs. As fixed by Govt. 1x10’s. 422. -do- Moxiflox 400mg Form-5 Avelox (Bayer Approved (1660) Tablet Dy. No: 194 Healthcare) Each film coated Tablet contains: Dated. USFDA Moxifloxacin (HCl) …….…. 08.05.2014 400mg Rs.20,000/- Abomox (Abbot (Broad Spectram antibiotic) Rs. As fixed by Lab.) (Mfg. Specs.) Govt. 5’s. 423. -do- Olanza 5mg Form-5 Zyprexa (Lilly) Approved (1663) Tablet Dy. No: 190 USFDA Each Tablet contains: Dated. Olanzapine …….…. 5mg 08.05.2014 Aziva (Noa (Antipsychotic) Rs.20,000/- Hemis) (mfg. Specs.) Rs. As fixed by Govt. 10’s. 424. -do- Olanza 10mg Form-5 Zyprexa (Lilly) Approved (1664) Tablet Dy. No: 195 USFDA Each Tablet contains: Dated. Olanzapine …….…. 10mg 08.05.2014 Aziva (Noa (Antipsychotic) Rs.20,000/- Hemis) (Mfg. Specs.) Rs. As fixed by Govt. 10’s. 425. -do- Tamol SR 50mg Form-5 Ultram (Jassen Deferred for (1661) Tablet Dy. No: 204 Pharma) USFDA Copy of Each sustained release Tablet Dated. official contains: 08.05.2014 Zultra (Wilshire) monograph Tramadol HCl …….…. 50mg Rs.20,000/- Confirmation (Analgesic) Rs. As fixed by of sustained (BP Specs.) Govt. release form in refrence 10’s. countries 426. -do- Rovustat 5mg Form-5 Crestor (IPR) Approved (1651) Tablet Dy. No: 197 USFDA
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Each Film coated Tablet contains: Dated. Rosuvastatin Calcium .…. 5mg 08.05.2014 Amsos (Amson) (Lipid Lowering agent) Rs.20,000/- (Mfg. Specs.) Rs. As fixed by Govt. 10’s. 427. -do- Vtor 50mg Form-5 Galvus 50mg Approved (1652) Tablet Dy. No: 203 (Novartis) MHRA Each Tablet contains: Dated. Vildagliptin …….…. 50mg 08.05.2014 Galvus 50mg (Antidiabetic) Rs.20,000/- Tablets (Novartis) (Mfg. Specs.) Rs. As fixed by Govt. 2x14’s. 428. -do- Vomigo 4mg Form-5 Zofran (Novartis) Deferred for (1655) Tablet Dy. No: 358 MHRA, USFDA confirmation of Each orally disintegrating Tablet Dated. already contains: 05.06.2012 Zofran (GSK) regisrered locally Ondansetron (as HCl Rs.8,000/- manufacturing brands in orally Dihydrate)……….…. 4mg 26.07.2013 disintegration (5-HT3 Receptor Antagonist) Rs.12,000/- form. (USP Specs.) Rs. As fixed by Govt. 10’s. 429. -do- Vomigo 8mg Form-5 Zofran (Novartis) Deferred for (1656) Tablet Dy. No: 355 MHRA, USFDA confirmation of Each orally disintegrating Tablet Dated. already contains: 05.06.2012 Zofran (GSK) regisrered locally Ondansetron (as HCl Rs.8,000/- manufacturing brands in orally Dihydrate)……….…. 8mg 26.07.2013 disintegration (5-HT3 Receptor Antagonist) Rs.12,000/- form. (USP Specs.) Rs. As fixed by Govt. 10’s. 430. -do- Bonema 35mg Form-5 Risedronate Approved (1658) Tablet Dy. No: 349 sodium (Teva Each Tablet contains: Dated. Pharm USA) Risedronate sodium (as 05.06.2012 USFDA hemipentahydrate)……….…. Rs.8,000/- 35mg 26.07.2013 Atconate (Atco) (Biophosphate Derivative) Rs.12,000/- (Mfg. Specs.) Rs. As fixed by Govt. 4’s. 431. -do- Tegased 6mg Form-5 Zelnorm (US Approved (1669) Tablet Dy. No: 350 Woorldmed LLC)
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Each Tablet contains: Dated. USFDA Tegaserod (as hydrogen 05.06.2012 maleate)……….…. 6mg Rs.8,000/- Zelmac (Novartis) (GI Serotonin receptor agonist) 26.07.2013 (Mfg. Specs.) Rs.12,000/- Rs. As fixed by Govt. 30’s. 432. M/s Allmed Incihep Tablet 375mg Form-5 Incivek by Vertex Deferred for (Private) Tablet Dy. No: 5136 Pharm (USFDA, confirmation of Limited, Lahore. Each film coated tablet contains: dated. MHRA) me too status (1695) Telaprevir...... 375mg 11-06-2012 (Protease Inhibitor) Rs.8000/- Me too not Manufacturer Specs. 22-06-2011 provided Rs.12,000/- As per PRC Prices / 7x6’s 433. -do- BIORAL Oral Solution Form-5 Cyclosporine by Deferred for (1696) Oral solution Dy. No: 5122 Abbvie (USFDA) clarification Each ml contains: dated. regarding cyclosporine...... 100mg 11-06-2012 Neocyspin by m/s manufacturing (Fungal metabolite Rs.8000/- Biocare requirement of immune Immunosuppressive) 22-06-2011 suppressants. Manufacturer Specs. Rs.12,000/- As per PRC Prices / 50 ml 434. -do- Parinox Form-5 Celaxane: Multi- Referred to (1786) Injection Dy. No: 6089 dose contain Biological Each 10ml vial contains: dated. 300mg/ 3ml vial Division Enoxparin Sodium……1000mg 02-07-2012 by m/s Snofi (Antithrombotic Group/ Heparin Rs.8000/- Aventis USFDA Group) 11-10-2012 Manufacturer Specs. Rs.12,000/- As per PRC Prices / 10 ml 435. -do- Letrole Form-5 Femara by Deferred for (1688) Tablet Dy. No: 5135 Novartis clarification Each film coated tablet contains: Dated. Pharmaceuticals regarding Letrozole…..2.5mg 11-06-2012 MHRA manufacturing (Non steroidal inhibitor of Rs.8000/- Losiral by m/s requirement . armatase enzyme ) 11-10-2012 consolidated Manufacturer Specs. Rs.12,000/- Chemical As per PRC Laboratories. Prices 30 tabs
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436. -do- Siroall Form-5 RAPAMUNE by Deferred for (1689) Tablet Dy. No: 5137 M/s Pfizer clarification Each tablet contains: Dated. USFDA, MHRA regarding Sirolimus……..1mg 11-06-2012 manufacturing (Immunosuppressor) Rs.8000/- RAPAMUNE by requirement of immune Manufacturer Specs. 11-10-2012 M/s wyeth suppressants. Rs.12,000/- (Reg# 031376) As per PRC Prices 10 tabs 437. -do- Proferrin Form-5 Me too not Deferred for (1694) Tablet Dy. No: 5131 provided confirmation of Each tablet contains: Dated. approval status Elemental Iron as Heme Iron 11-06-2012 in reference Polypeptide….12mg Rs.8000/- countries and Pakistan. (Dietary Supplement) 11-10-2012
Manufacturer Specs. Rs.12,000/- As per PRC Prices 10’s,30’s tabs 438. -do- Defox Form-5 Exjade by Approved (1691) Tablet Dy. No: 6082 Novartis Each tablet contains: Dated. International Deferasirox……100mg 02-07-2012 USFDA (Iron chelating agent) Rs.8000/- Asunra by Manufacturer Specs. 11-10-2012 Novartis Rs.12,000/- As per PRC Prices 30’s 439. M/s High-Q B Pirokeu Plus 20mg Form-5 Not provided Deferred for 64, KDA-1, Tablet Dy. No: 227 Karsaz Road, Each effervescent Tablet contains: dated. Commitment st Karachi. Piroxicam (Betacyclodextrin 16.04.2011 Not provided as per 251 (984) complex) ………. 20mg Rs.8,000/- meeting not (NSAIDs) Differential fee provided by the Firm. (Mfg. Specification) Challan not Last attached. inspection Rs. As per leader report price. required. 20’s Approval status of effervescent tablets in reference countries and Pakisatn. Differential fee Challan.
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440. M/s Getz Sytam XR 500mg Form-5-D Keppra XR (UCB Approved as Pharma, Karachi Tablets Dy. No: 193 INC) USFDA firm has -do- Each extended release tablet dated. provided Form 5. (1366) contains: 14.06.2011 Levetiracetam ……. 500mg Rs.15,000/- Lerace XR (Hilton (Antiepileptic) 19.09.2013 Pharma Pvt Ltd.) (Mfg. Specification) Rs. 5,000/- Rs. 1088/10’s, 2176/20’s 441. -do- Sytam XR 750mg Form-5-D Keppra XR (UCB Deferred for (1402) Tablets Dy. No: 193 INC) USFDA Stability studies st Each extended release tablet dated. as per 251 contains: 14.06.2011 meeting Levetiracetam ……. 750mg Rs.15,000/- Not provided guidelines of RB. (Antiepileptic) 30.07.2013 (Mfg. Specification) Rs.35,000/- Rs. 1231/10’s, 2462/20’s 442. -do- Sytam 1000mg Form-5-D Keppra (UCB Approved as (1141) Tablets Dy. No: 191 Pharma Ltd.) firm has Each film coated tablet contains: dated. USFDA provided Form 5. Levetiracetam ……. 1000mg 14.06.2011 (Antiepileptic) Rs.15,000/- Keppra (GSK (Mfg. Specification) 19.09.2013 Pakistan) Rs. 5,000/- Rs. 1232/10’s, 2464/20’s 443. -do- Sytam 750mg Form-5 Keppra (UCB Approved (1403) Tablets Dy. No: 194 Pharma Ltd.) Each film coated tablet contains: dated. USFDA Levetiracetam ……. 750mg 14.06.2011 (Antiepileptic) Rs.8,000/- Lerace (Hilton (Mfg. Specification) 19.09.2013 Pharma Pvt Ltd.) Rs.12,000/- Rs. 985/10’s, 1970/20’s 444. -do- Sytam 500mg Form-5 Keppra (UCB Approved (1490) Tablets Dy. No: 196 Pharma Ltd.) Each film coated tablet contains: dated. USFDA Levetiracetam ……. 500mg 14.06.2011 (Antiepileptic) Rs.8,000/- Lerace (Hilton) (Mfg. Specification) 19.09.2013 Rs.12,000/- Rs. 870/10’s, 1740/20’s 445. -do- Montizal 10/5mg Form-5-D Not provided Rejected as
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(2052) Tablets Dy. No: 210 formulation is Each tablet contains: dated. Not provided not approved by Montelukast (as sodium) 17.03.2011 reference ……………. 10mg Rs.15,000/- regulatory Levocetirizine 05.09.2013 authorities. Dihydrochloride………5mg Rs.35,000/- (Anti Leukotriene/ antihistamine) Rs. 1260/14’s, (Mfg. Specification) 1800/20’s Indication:- it is indicated for treatment of chronic allergic conditions like seasonal allergic rhinitis, perennial allergic rhinitis, rhinitis associated with asthma and chronic urticaria. 446. -do- Reprox 500/85mg Form-5-D Treximet (Pernix Deferred for the (2026) Tablets Dy. No: 11 Ireland Ltd) conformation of Each film coated tablet contains: dated. USSFDA me too status. Naproxen Sodium………. 500mg 02.05.2011 Sumatriptan Succinate USP eq to Rs.15,000/- Sumoxen (Atco) Sumatriptan …………85mg 05.09.2013 (NSAIDs+5-HT1 receptor agonist) Rs.35,000/- (Mfg. Specification) Rs. 621/2’s, Indication:- it is indicated for 1863/6’s acute migraine attack with without aura in adults. 447. -do- Zinco Granules for Oral Form-5 Not provided Deferred for (1365) Suspension Dy. No: 416 expert opinion Oral powder Suspension dated. Yes 2 zinc (Zafa comments of Each 5ml contains: 30.05.2011 Pharmaceuticals) WHO Pakistan. Zinc Sulfate Rs.8,000/- Monohydrate….………. 20mg 19.09.2013 (Zinc Supplement) Rs.12,000/- (Mfg. Specification) Rs. 100/60ml, 200/120ml. 448. -do- Rocurex 25mg/2.5ml Form-5 Esmeron (Merk Deferred for the (2057) Injection Dy. No: 2239 sharp) MHRA confirmation of Each ml contains: dated. me too status. Rocuronium Bromide 12.12.2012 Esmeron USP………10mg Rs.20,000/- 5ml(OBS Health (Non-depolarizing neuromuscular Rs. 1200/1’s, care)p.920 blocking agent/ muscle relaxant) 6,000/5’s (Mfg. Specification) 449. M/s Zafa Zampi-Sul 4500mg Form-5 Not Provided Deferred for the Pharmaceutical Injection Dy. No: 189 confirmation of Laboratories Each vial contains: Dated. Sulbarax me too status. (Private) Ltd, Ampicillin Sodium eq. to 14.03.2011 (Mediceena)
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B-10, SITE Ampicillin …………… 3000mg Rs.8,000/- p.556 Karachi. Sulbactam sodium eq. to 01.08.2013 (920) sulbactam……………….1500mg Rs.12,000/- (Semisynthetic penicillins) As per SRO (USP Specs) 1’s 450. M/s Zafa Magsuf 50%w/v, 2ml in plastic Form-5 Magnesium Deferred for Pharmaceutical container. Dy. No: 1386 Sulphate 50%w/v clarification as Laboratories Injection Dated. solution for same formulation (Private) Ltd, Each ml contains: 27.08.2012 injection. (Tobay as already is also L-1/B, Block-22, Magnesium Rs.8,000/- & South Devon registered with M/s Zafa. Fedral B Sulfate.(7H2O)……………500mg 01.08.2013 NHS Foundation industrial Area (Eclempia, Pre-eclempia) Rs.12,000/- Trust) MHRA Karachi. (USP Specs) As per PRC (1839) (6’sx2ml) Mag-S (Mass Pharma)
451. M/s Zafa Magsuf 50%w/v, 10ml plastic Form-5 Magnesium Deferred for Pharmaceutical Container. Dy. No: 1387 Sulphate 50%w/v clarification as Laboratories Injection Dated. solution for same formulation (Private) Ltd, Each ml contains: 27.08.2012 injection. (Tobay as already is also L-1/B, Block-22, Magnesium Rs.8,000/- & South Devon registered with M/s Zafa. Fedral B Sulfate.(7H2O)……………500mg 01.08.2013 NHS Foundation industrial Area (Eclempia, Pre-eclempia) Rs.12,000/- Trust) MHRA Karachi. (USP Specs) As per SRO (1838) (6’x10ml) Mag-S (Mass Pharma)
452. M/s Zafa Zariva 400mg. Form-5 Deferred for the Pharmaceutical Capsule Dy. No: 190 Ribazole (Getz confirmation of Laboratories Each capsule contains: Dated. Pharma) approval status (Private) Ltd, Ribavirin USP …………400mg 14.03.2011 by reference L-4/1 A&B, (J 5 Antiviral) Rs.8,000/- regulatory authorities Block-21, Fedral (Zafa Specs) 01.08.2013 B Industrial Area Rs.12,000/- Karachi. As per SRO (918) 10’s 453. M/s Zafa Zariva 600mg. Form-5 Deferred for the Pharmaceutical Capsule Dy. No: 191 Ribazole (Getz confirmation of Laboratories Each capsule contains: Dated. Pharma) approval status (Private) Ltd, Ribavirin USP …………600mg 14.03.2011 by reference L-4/1 A&B, (J 5 Antiviral) Rs.8,000/- regulatory authorities Block-21, Fedral (Zafa Specs) 01.08.2013 B Industrial Area Rs.12,000/- Karachi. As per SRO
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(921) 10’s 454. M/s Zafa Xynosine Saline Nasal Spray. Form-5 Deferred for the Pharmaceutical Nasal Spray Dy. No: 1360 confirmation of Laboratories Each ml contains: Dated. approval status (Private) Ltd, Sodium chloride………6.5mg 31.10.2012 by reference L-4/1 A&B, (Nasel congestion, Electrolytel) Rs.20,000/- regulatory authorities Block-21, Fedral (Zafa Specs) As per SRO B Industrial Area 1’sx30ml Karachi. (1961) 455. M/s CCL Evergraf 0.25mg Form-5 Zortress Deferred for the Pharmaceuticals Tablet Dy. No: 7393 (Novartis) confirmation of (Pvt) Ltd., 62- Each tablet contains: Dated. USFDA manufacturing Industrial Estate, Everolimus M.S. ………0.25mg 01.10.2012 facility for Kot Lakhpat, (Immunosuppressant) Rs.20,000/- Certican immune- suppressant. Lahore. (CCL Specs) As per Leader (Novartis) P.826
(1179) Brand 30’s, 60’s. 456. -do- Evergraf 0.5mg Form-5 Afinitor Deferred for the (1180) Tablet Dy. No: 7394 (Novartis) confirmation of Each tablet contains: Dated. USFDA manufacturing Everolimus M.S. ………0.5mg 01.10.2012 facility for (Immunosuppressant) Rs.20,000/- immune- suppressant. (CCL Specs) As per Leader
Brand 30’s, 60’s. 457. -do- Evergraf 0.75mg Form-5 Afinitor Deferred for the (1181) Tablet Dy. No: 7395 (Novartis) confirmation of Each tablet contains: Dated. USFDA manufacturing Everolimus M.S. ………0.75mg 01.10.2012 facility for (Immunosuppressant) Rs.20,000/- Certican immune- suppressant. (CCL Specs) As per Leader (Novartis) P.826
Brand 30’s, 60’s. 458. -do- Evergraf 1.0mg Form-5 Afinitor Deferred for the (1182) Tablet Dy. No: 7396 (Novartis) confirmation of Each tablet contains: Dated. USFDA manufacturing Everolimus M.S. ………1.0mg 01.10.2012 facility for (Immunosuppressant) Rs.20,000/- immune- suppressant. (CCL Specs) As per Leader
Brand 30’s, 60’s. 459. M/s Martin Dow Amlotel Tablet 40/5mg Form-5 Telmisartan, Approved Limited, Korangi Tablets Dy. No: 191 Amlodipine Industrial Area, Each tablet contains: dated. (Mylan pharm Karachi-74900 Telmisartan USP ….40mg 01.02.2012 Inc.) USFDA
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(1850)2012 Amlodipine as besylate USP Rs.8,000/- …..5mg 13.11.2013 Amtas (Getz) (Combination of angiotensin II Rs.12,000/- receptor antagonist & calcium Rs. 320.36/10’s channel blocker.) 448.50/14’s (Manufacturer’s specs) 640.71/20’s 961.07/30’s
460. -do- Amlotel Tablet 80/10mg Form-5 Telmisartan, Approved (1903)2012 Tablets Dy. No: 192 Amlodipine Each tablet contains: dated. (Mylan pharm Telmisartan USP ….80mg 01.02.2012 Inc.) USFDA Amlodipine as besylate USP Rs.8,000/- …..10mg 13.11.2013 Telmis-A (Genix) (Combination of angiotensin II Rs.12,000/- receptor antagonist & calcium Rs. 533.93/10’s channel blocker.) 747.50/14’s (Manufacturer’s specs) 1067.86/20’s 1601.79/30’s
461. -do- Amvel 10/160mg Form-5 Exforge (Novartis Approved (963) Tablet Dy. No: 859 Pharmaceuticals Each film coated tablet contains: dated. Corp. US) Amlodipine (USP) …. 10mg 29.05.2012 Valsartan (USP) … 160mg Rs.8,000/- Amstan (Getz (Angiotensin II antagonist + 20.11.2013 Pharma Pakistan Calcium channel blocker) Rs.12,000/- (Pvt.) Ltd) (USP specs) Rs. 900.00/10’s 1260.00/14’s 1800.00/20’s 2520.00/28’s 2700.00/30’s 462. -do- Amvel 5/80mg Form-5 Exforge (Novartis Approved (935) Tablet Dy. No: 848 Pharmaceuticals Each film coated tablet contains: dated. Corp. US) MHRA Amlodipine (USP) …. 5mg 29.05.2012 Valsartan (USP) … 80mg Rs.8,000/- Amstan (Getz (Angiotensin II antagonist + 20.11.2013 Pharma Pakistan Calcium channel blocker) Rs.12,000/- (Pvt.) Ltd) (USP specs) Rs. 500.00/10’s 700.00/14’s 1000.00/20’s 1400.00/28’s 1500.00/30’s 463. -do- Amvel 10/80mg Form-5 Exforge (Novartis Deferred for (936) Tablet Dy. No: 845 Pharmaceuticals confirmation of
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Each film coated tablet contains: dated. Corp. US) same formulation Amlodipine (USP) …. 10mg 29.05.2012 approval status Valsartan (USP) … 80mg Rs.8,000/- Amstan (Getz by reference (Angiotensin II antagonist + 20.11.2013 Pharma Pakistan regulatory Calcium channel blocker) Rs.12,000/- (Pvt.) Ltd) authorities (USP specs.) Rs. 870.54/10’s 1218.75/14’s 1741.07/20’s 2437.50/28’s 2611.61/30’s 464. -do- Anzolam 1mg Form-5 Xanax Approved (1636)2012 Tablet Dy. No: 213 (Pharmacia & Each tablet contains: dated. Upjohn) USFDA Alprazolam USP …. 1mg 29.03.2013 (Benzodiazepine Derivative) Rs.20,000/- Xanax (Pfizer (USP specs) Rs. 232.33/10’s Laboratories Ltd.) 464.67/20’s 697.00/30’s 465. -do- Anzolam 0.5mg Form-5 Xanax Approved (1635) Tablet Dy. No: 213 (Pharmacia & Each tablet contains: dated. Upjohn) USFDA Alprazolam USP …. 0.5mg 29.03.2013 (Benzodiazepine Derivative) Rs.20,000/- Xanax (Pfizer (USP specs) Rs. 139.33/10’s Laboratories Ltd.) 278.67/20’s 418.00/30’s 466. -do- Anzolam XR 1mg Form-5 Xanax XR Approved (1633)2012 Tablet Dy. No: 214 (Pharmacia & Each extended release tablet dated. Upjohn) USFDA contains: 29.03.2013 Alprazolam USP …. 1mg Rs.20,000/- Xanax XR (Pfizer (Benzodiazepine Derivative) Rs. 153.27/10’s Laboratories Ltd.) (USP specs) 306.53/20’s 459.80/30’s 467. -do- Anzolam XR 2mg Form-5 Xanax XR Approved (1634)2012 Tablet Dy. No: 212 (Pharmacia & Each extended release tablet dated. Upjohn) USFDA contains: 29.03.2013 Alprazolam USP …. 2mg Rs.20,000/- Xolam (Global (Benzodiazepine Derivative) Rs. 255.57/10’s Pharma) (USP specs) 511.13/20’s 766.70/30’s 468. -do- Estaxa 1mg Form-5 Lunesta Approved (1565)2012 Tablet Dy. No: 309 (Sunovion Pharms Each film coated tablet contains: dated. Inc) USFDA Eszopiclone …. 1mg 23.06.2011
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(Hypnotic Agent (Non- Rs.8,000/- Clonexa (Atco Benzodiazepine)) 31.07.2013 Laboratories) (Mfg. Specs.) Rs.12,000/- Rs. 140.00/10’s 280.00/20’s 420.00/30’s 469. -do- Gajni ODT 5mg Form-5 Aricept (Eisai Inc) Deferred for the (1563)2012 Tablet Dy. No: 631 USFDA, MHRA confirmation of Each orally disintegrating tablet dated. approval status contains: 27.12.2011 Donep (Genetics) in oral Donepezil HCl …. 5mg Rs.8,000/- p.1070 disintegrated dosage form in (Anticholinestrase) 31.07.2013 Pakistan. (USP Specs) Rs.12,000/- Rs. 310.50/10’s 621.00/20’s 931.50/30’s 470. -do- Gajni ODT 10mg Form-5 Aricept (Eisai Inc) Deferred for the (1564)2012 Tablet Dy. No: 630 USFDA, MHRA confirmation of Each orally disintegrating tablet dated. approval status contains: 27.12.2011 Donep (Genetics) in oral Donepezil HCl …. 10mg Rs.8,000/- p.1070 disintegrated dosage form in (Anticholinestrase) 31.07.2013 Pakistan. (USP Specs) Rs.12,000/- Rs. 451.20/10’s 902.40/20’s 1353.60/30’s 471. -do- Gajni 23mg Form-5 Aricept (Eisai Inc) Deferred for (1589)2012 Tablet Dy. No: 340 USFDA, MHRA confirmation of Each film coated tablet contains: dated. me too status in Donepezil HCl …. 23mg 17.10.2011 Me too not Pakistan. (Anticholinestrase) Rs.8,000/- provided (USP Specs) 31.07.2013 Rs.12,000/- Rs. 248.16/10’s 496.32/20’s 744.48/30’s 472. -do- Alvin 150mg Form-5 Tekturna Approved (1494) Tablets Dy. No: 1295 (Novartis Each film coated tablet contains: dated. pharmaceuticals Aliskiren as hemifumarate……… 30.07.2012 Corp US) USFDA 150mg Rs.8,000/- (Renin Inhibitor) 20.11.2013 Rasilez (Novartis (Mfg. Specs) Rs.12,000/- Pharma (Pakistan) Rs. 588.00/7’s Limited) p.356 840.00/10’s 1176.00/14’s
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1680.00/20’s 2352.00/28’s 2520.00/30’s 473. -do- Alvin 300mg Form-5 Tekturna Approved (1495) Tablets Dy. No: 1298 (Novartis Each film coated tablet contains: dated. pharmaceuticals Aliskiren as hemifumarate……… 30.07.2012 Corp US) USFDA 300mg Rs.8,000/- (Renin Inhibitor) 20.11.2013 Rasilez (Novartis (Mfg. Specs) Rs.12,000/- Pharma (Pakistan) Rs. 982.80/7’s Limited) p.356 1404.00/10’s 1965.60/14’s 2808.00/20’s 3931.20/28’s 4212.00/30’s 474. -do- Alvin-H 150/25mg Form-5 Tekturna HCT Approved (1505) Tablets Dy. No: 1299 (Novartis Each film coated tablet contains: dated. pharmaceuticals Aliskiren as hemifumarate……… 30.07.2012 Corp US) USFDA 150mg Rs.8,000/- Hydrochlorothiazide USP … 20.11.2013 25mg Rs.12,000/- Alvia HCT (Atco) (Renin Inhibitor + thiazide Rs. 547.80/7’s (058665) diuretic) 782.57/10’s (Mfg. Specs) 1095.60/14’s 1565.14/20’s 2191.20/28’s 2347.71/30’s 475. -do- Alvin-H 300/25mg Form-5 Tekturna HCT Approved (1507) Tablets Dy. No: 1296 (Novartis Each film coated tablet contains: dated. pharmaceuticals Aliskiren as hemifumarate……… 30.07.2012 Corp US) USFDA 300mg Rs.8,000/- Hydrochlorothiazide USP … 20.11.2013 Rasilez HCT 25mg Rs.12,000/- (Novartis Pharma (Renin Inhibitor + thiazide Rs. 912.60/7’s (Pakistan) diuretic) 1303.71/10’s Limited) p.358 (Mfg. Specs) 1825.20/14’s 2607.43/20’s 3650.40/28’s 3911.14/30’s 476. -do- Alvin-H 300/12.5mg Form-5 Tekturna HCT Approved (1506) Tablets Dy. No: 1299 (Novartis Each film coated tablet contains: dated. pharmaceuticals Aliskiren as hemifumarate……… 30.07.2012 Corp US) USFDA
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300mg Rs.8,000/- Hydrochlorothiazide USP … 20.11.2013 Rasilez HCT 12.5mg Rs.12,000/- (Novartis Pharma (Renin Inhibitor + thiazide Rs. 912.60/7’s (Pakistan) diuretic) 1303.71/10’s Limited) p.358 (Mfg. Specs) 1825.20/14’s 2607.43/20’s 3650.40/28’s 3911.14/30’s 477. -do- Alvin-H 150/12.5mg Form-5 Tekturna HCT Approved (1496) Tablets Dy. No: 1294 (Novartis Each film coated tablet contains: dated. pharmaceuticals Aliskiren as hemifumarate……… 30.07.2012 Corp US) USFDA 150mg Rs.8,000/- Hydrochlorothiazide USP … 20.11.2013 Skiren Plus (Getz) 12.5mg Rs.12,000/- (066805) (Renin Inhibitor + thiazide Rs. 547.80/7’s diuretic) 782.57/10’s (Mfg. Specs) 1095.60/14’s 1565.14/20’s 2191.20/28’s 2347.71/30’s 478. -do- Dowphage ER 750mg Form-5 Glucophage SR Approved (1842) Tablets Dy. No: 639 (Merck Serono Each film coated extended release dated. Ltd.) MHRA tablet contains: 27.12.2011 Metformin HCl……… 750mg Rs.8,000/- D-Formin (Getz) (Biguanide) 31.07.2013 (061349) (USP Specs) Rs.12,000/- Rs. 75.71/30’s 126.18/50’s 252.35/100’s 479. -do- Dowphage ER 1000mg Form-5 Glucophage SR Approved (1843) Tablets Dy. No: 640 (Merck Serono Each film coated extended release dated. Ltd.) MHRA tablet contains: 27.12.2011 Metformin HCl……… 1000mg Rs.8,000/- Diabescot XR (Biguanide) 31.07.2013 (Scotman) p.163 (USP Specs) Rs.12,000/- Rs. 117.00/30’s 195.00/50’s 390.00/100’s 480. -do- Vibond Form-5 Boniva (Roche Approved (1847) Tablets Dy. No: 259 Therapeutic Inc) Each film coated tablet contains: dated. USFDA Ibandronate sodium monohydrate 23.05.2011
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equivalent to Ibandronate ……. Rs.8,000/- Bionic (S. J. & 150mg 31.07.2013 Fazal Elahi) p.930 (Biphosphonate) Rs.12,000/- (Mfg. Specs) Rs. 400/1’s
481. -do- Bevin 20mg Form-5 Bystolic (Forest Deferred for (1484) Tablets Dy. No: 220 Labs) USFDA confirmation of Each tablet contains: dated. me too status. Nebivolol (as HCl) ……. 20mg 19.05.2011 Me too not (Selective Beta- Receptor Rs.8,000/- provided. Blocking Agent) 31.07.2013 (Mfg. Specs) Rs.12,000/- Rs. 600/10’s
482. -do- Bevin 2.5mg Form-5 Bystolic (Forest Approved (1482) Tablets Dy. No: 221 Labs) USFDA Each tablet contains: dated. Nebivolol (as HCl) ……. 2.5mg 19.05.2011 Byscard (Searle) (Selective Beta- Receptor Rs.8,000/- Blocking Agent) 31.07.2013 (Mfg. specs) Rs.12,000/- Rs. 100/10’s
483. -do- Bevin 5mg Form-5 Bystolic (Forest Approved (1460) Tablets Dy. No: 222 Labs) USFDA Each tablet contains: dated. Nebivolol (as HCl) ……. 5mg 19.05.2011 Byscard (Searle) (Selective Beta- Receptor Rs.8,000/- Blocking Agent) 31.07.2013 (Mfg. specs) Rs.12,000/- Rs. 200/10’s
484. -do- Euglucon 10mg Form-5 Deferred for (1810) Tablets Dy. No: 233 confirmation of Each tablet contains: dated. approval status Glibenclamide ……. 10mg 18.03.2011 by reference (Oral Hypoglycemics) Rs.8,000/- regulatory authorities and (Mfg. Specs) 31.07.2013 Pakistan. Rs.12,000/- Rs. 143.06/60’s
485. -do- Euglucon 2.5mg Form-5 Glibenclamide Approved (1809) Tablets Dy. No: 230 (Wockhardt) Each tablet contains: dated. MHRA Glibenclamide ……. 2.5mg 18.03.2011 (Oral Hypoglycemics) Rs.8,000/- Semi Glicon
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(Mfg. Specs) 31.07.2013 (Efroze) Rs.12,000/- Rs. 53.66/60’s 486. -do- Varico 450/50mg Form-5 Daflon (Les Approved (1590) Tablets Dy. No: 170 laboratories Each film coated tablet contains: dated. servier) France Diosmin (EP) ……. 450mg 30.01.2012 Hesperidin ………..50mg Rs.8,000/- Daflon (Servier) (Bioflavonoids) 13.11.2013 (Mfg. Specs) Rs.12,000/- Rs. 182.00/10’s 364/20’s 546/30’s 487. -do- Prefia 5mg Form-5 Effient (Eli Lilly Approved (1812) Tablets Dy. No: 5 Australia) TGA Each film coated tablet contains: dated. Prasugrel (HCl) ……. 5mg 02.05.2011 Eficlot (CCL) (Pletelet inhibitor) Rs.8,000/- (Mfg. Specs) 20.11.2013 Rs.12,000/- Rs. 105.38/10’s 488. -do- Prefia 10mg Form-5 Effient (Eli Lilly Approved (1813) Tablets Dy. No: 7 Australia) TGA Each film coated tablet contains: dated. Prasugrel (HCl) ……. 10mg 02.05.2011 Eficlot (CCL) (Pletelet inhibitor) Rs.8,000/- (Mfg. Specs) 20.11.2013 Rs.12,000/- Rs. 175/10’s 489. -do- Riplan Plus Form-5 Deferred for (1811) Tablets Dy. No: 297 Locril Plus confirmation of Each film coated tablet contains: dated. (Mactar) approval by Outer Core: 23.04.2011 reference Clopidogrel (as bisulfate) USP Rs.8,000/- regulstaory authorities ……. 75mg 31.07.2013 Inner Core: Rs.12,000/- Aspirin (Enteric Coated) USP Rs. 150/10’s ………150mg (Pletelet deaggregator/ NSAID) (Mfg. Specs) 490. -do- Prostol 200mcg Form-5 Cytotec (Pfizer) Approved (1849) Tablets Dy. No: 98 MHRA Each tablet contains: dated. Misoprostol USP ……. 200mcg 26.01.2012 Prosotec (Atco) (Prostaglandin) Rs.8,000/- p.64 (Mfg. Specs) 13.11.2013
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Rs.12,000/- Rs. 150/10’s 300.00/20’s 450.00/30’s 491. -do- Vintag 100mg Form-5 Vimpat (UCB Approved (1638) Tablets Dy. No: 154 INC) USFDA Each film coated tablet contains: dated. Lacosamide ……. 100mg 11.04.2011 Lacolep (Hilton) (Anticonvulsants) Rs.15,000/- (Mfg. Specs) 31.07.2013 Rs.5,000/- As per SRO 10’s,14’s,28’s 492. -do- Vintag 150mg Form-5 Vimpat (UCB Approved (1639) Tablets Dy. No: 157 INC) USFDA Each film coated tablet contains: dated. Lacosamide ……. 150mg 11.04.2011 Lacolep (Hilton) (Anticonvulsants) Rs.15,000/- (Mfg. Specs) 31.07.2013 Rs.5,000/- As per SRO 10’s,14’s,28’s 493. -do- Viglip-M Form-5 Eucreas (Novartis Approved (934) Tablets Dy. No: 375 Pharmaceuticals Each film coated tablet contains: dated. UK Ltd.) MHRA Vildagliptin ……. 50mg 28.05.2011 Metformin HCl……… 1000mg Rs.8,000/- Galvus Met (Anti Hyperglycemic) 31.07.2013 (Novartis Pharma (Mfg. specs) Rs.12,000/- (PAK) Ltd) p.170 Rs. 850.63/10’s 2551.80/30’s 494. -do- Muwenta 4mg Form-5 EMA approved Approved (1413) Tablets Dy. No: 1563 Each film coated tablet contains: dated. Relspasm Thiocolchicoside ……. 4mg 21.08.2013 (Wilshire) (centrally acting agent) Rs.20,000/- (Mfg. specs) Rs. 300.00/10’s 600.00/20’s 900.00/30’s 495. -do- Muwenta 8mg Form-5 Not provided Deferred for (1425) Tablets Dy. No: 1562 confirmation of Each film coated tablet contains: dated. Relspasm approval status Thiocolchicoside ……. 8mg 21.08.2013 (Wilshire) by reference (centrally acting agent) Rs.20,000/- regulatory authorities (Mfg. specs) Rs. 405.00/10’s
810.00/20’s
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1215.00/30’s 496. -do- Dowphage 500mg Form-5 Glucophage SR Approved (1814) Tablets Dy. No: 637 (Merck Serono Each film coated extended release dated. Ltd.) MHRA tablet contains: 27.12.2011 Metformin HCl……… 500mg Rs.8,000/- Metwil XR (Biguanide) 31.07.2013 (Wilson) (USP Specs) Rs.12,000/- (035901) Rs. 63.96/30’s 106.60/50’s 213.20/100’s 497. -do- Dowphage 850mg Form-5 Deferred for the (1844) Tablets Dy. No: 638 Metwil XR confirmation of Each film coated extended release dated. (Wilson) approval status tablet contains: 27.12.2011 (035901) in reference Metformin HCl……… 850mg Rs.8,000/- countries as XR. (Biguanide) 31.07.2013 (USP Specs) Rs.12,000/- Rs. 85.80/30’s 143/50’s 286/100’s 498. -do- Tirace ER 500mg Form-5 Keppra XR (UCB Approved (1449) Tablets Dy. No: 397 Pharma Ltd.) Each film coated extended release dated. USFDA tablet contains: 28.10.2011 Levetiracetam ……. 500mg Rs.8,000/- Lerace (Hilton) (Antiepileptic) 31.07.2013 (USP specs.) Rs.12,000/- Rs. 783.00/10’s 1566.00/20’s 2349.00/30’s 499. -do- Bilberry chewable 262.5mg Form-5 Pepto-Bismol Deferred for (1391) Tablets Dy. No: 1237 (Procter & submission of Each chewable tablet contains: dated. Gamble Form 5D along Bismuth Subsalicylate USP……. 12.10.2012 Ltd)MHRA with requisuite 262.5mg Rs.20,000/- documents. The Board advised to (Antidiarrhoeal) Rs. 64.19/10’s Bismol (Macter) registration (Mfg specs.) 128.38/20’s holders of 192.57/30’s strength 265mg to provide approval status by reference regulatory authorities
500. -do- Elepra 50mg Form-5 Inspra - Pfizer Approved
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(1509) Tablet Dy. No: 467 (USFDA) Each film coated tablet contains: dated 18-04-2012 Eplerenone…… 50mg Rs.8,000/- Macrenone- Steroidal antimineralocorticoid - 13.11.2013 Macter Aldosterone receptor antagonist Rs.12,000/- Manufacture Specification 10’s Rs. 702/- 14’s Rs. 982.80 20’s Rs. 1404. 30’s Rs. 2106. 501. -do- Estaxa 2mg Form-5 Lunesta Approved (1566) Tablet Dy. No: 303 (Sunovion Pharms Each film coated tablet contains: dated. Inc) USFDA Eszopiclone …. 2mg 23.06.2011 (Hypnotic Agent (Non- Rs.8,000/- Clonexa (Atco Benzodiazepine)) 31.07.2013 Laboratories) (Mfg. Specs.) Rs.12,000/- Rs. 280/10’s 560.00/20’s 840.00/30’s 502. M/s Pharmatec Halotec Plain Form-5 Haloperidol Approved Pakistan (Pvt) Injection Dy. No: 372 (Amdipharm Ltd, D-86/A Each ml contains: dated. Mercury SITE Karachi- Haloperidol ……….5mg 19.10.2011 xcompany) 74900 (Antipsychotic) Rs.8,000/- MHRA (1883) (Manufacturer’s specs) 13.03.2014 Rs.12,000/- Gendol (Genetics) Rs. 250/25x 1ml 503. -do- Morease Form-5 Diclegis Approved (1885) Tablet Dy. No: 1660 (Duchesnay) Each tablet contains: dated. USFDA Doxylamine Succinate ……10mg 02.10.2012 Vitamin B6 ……….. 10mg Rs.20,000/- Pregnova (ICI) (Anti allergic) As per SRO (Manufacturer’s specs) 30’s
504. -do- Myra Form-5 Deferred for the (1886) Tablet Dy. No: 1659 submission of Each tablet contains: dated. following:- Acetaminophen ……250mg 02.10.2012 Confirmation of Prambrom…………25mg Rs.20,000/- approval status in reference Magnesium Salicylate……250mg As per SRO countries and (Analgesic/ diuretic) 30’s Pakistan (………… specs) Commitment as per 251st meeting not provided.
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Specs reference Manufacturing method. 505. M/s Cirin Febridol 100ml Form-5 acetaminophen Approved Pharmaceuticals Infusion Dy. No: 1064 (Fresenius Kabi Pvt. Limited, Each ml contains: dated. USA) USFDA 32/2-A, Phase Acetoaminophen USP…. 10mg 20.12.2012 III, Industrial (NSAIDs) Rs.20,000/- estate Hattar, (Manufacturer’s specs) Rs. As per SRO Falgan (Bosch) District Haripur, 100ml Last inspection KPK, Pakistan. report dated (2081) 07.11.2015.
Replies of deferred cases of previous meetings:
Firm has rectified shortcomings pointed out in last meeting.
506. M/s OBS Xifadote 550mg Form-5 Xifaxan (Salix Product was Approved Pakistan Tablet Dy. No: 231 Pharms) deferred in (Pvt) Ltd, Each film coated tablet Dated. USFDA 256th meeting of C14 SITE contains: 11.10.2013 RB for Karachi. Rifaximin B.P……..550mg Rs.20,000/- Nimixa (Getz) following. (1217) (Antibacterial) Rs.572.94/- Commitment as (Mfg. Specs) 10’s, per 251st meeting of RB not provided. Inspection report is dated 11.02.2013. Reference of specification required.
507. M/s OBS Xifadote 200mg Form-5 Xifaxan (Salix Product was Approved Pakistan Tablet Dy. No: 232 Pharms) deferred in (Pvt) Ltd, Each film coated tablet Dated. USFDA 256th meeting of C14 SITE contains: 11.10.2013 RB for Karachi. Rifaximin B.P……..200mg Rs.20,000/- Nimixa (Getz) following. (1216) (Antibacterial) Rs.197.54/- Commitment as (Mfg. Specs.) 10’s, per 251st meeting of RB not provided. Inspection
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report is dated 11.02.2013. Reference of specification required. 508. M/s Zafa Zampi-Sul 1500mg Form-5 Ampicillin/ Case was Approved Pharmace Injection Dy. No: 650 Sulbactam deferred in utical Each vial contains: Dated. (Antibiotics 256th meeting Laboratori Ampicillin Sodium eq. to 15.03.2011 SA) for following:- es Ampicillin …………… Rs.8,000/- US FDA Commitment as (Private) 1000mg 01.08.2013 per 251st Ltd, B- Sulbactam sodium eq. to Rs.12,000/- Sulbarax meeting not 10, SITE sulbactam……………….500 As per SRO (Mediceena) provided by the Karachi. mg 1’s Firm. (913) (Semisynthetic penicillins) Last inspection (USP Specs) report of 06-01- 2010 provided. Clarification required regarding weighing and mixing of material in sterile area. List of equipment of penicillin injection section required. Copy of reference monograph required. Differential fee not attached. 509. M/s Obson Clopidob Tablet 75mg Form-5 USFDA, Deferred in Approved Pharmace Tablet Dy. No: MHRA 255th meeting uticals, Each film coated tablet 1539 dated. for: 209-S contains: 04-08-2011 Commitment as Industrial Clopidogrel Rs.8000/- Clopid By M/s per 251st Estate Kot (Bisulphate)...75mg 22-06-2011 Ferozsons. meeting. Lakhpat, (Anti Thrombic) Rs.12,000/- Last inspection Lahore. USP Specs As per SRO report. / Copy of official 10’s monograph for testing method.
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Details of coating material. Form 5 in order as per Rule 26 (1). Details of product specs. 510. -do- Denicon Form-5 Zanaflex by m/s Deferred in Approved Tablet Dy. No: cephalon. 255th meeting Each tablet contains: 2755 dated. (MHRA, US for: Tizanidine Hcl (USP)…2mg 23-06-2011 FDA) Commitment as (skeletal muscle relaxant) Rs.8000/- per 251st USP Specs. Rs.12,000/- Musidin by m/s meeting not As per SRO martin dow provided by the / Pakistan Firm. 1x10’s limited. Last inspection report is dated 05-01-2009. Form 5 is not in order as per Rule 26 (1). Details of analytical method along with manufacturing method required. 511. -do- Denicon fort Form-5 Zanaflex by m/s Deferred in Approved Tablet Dy. No: cephalon. 255th meeting Each tablet contains: 2756 dated. (MHRA, US for: Tizanidine Hcl (USP)…4mg 23-06-2011 FDA) Commitment as (skeletal muscle relaxant) Rs.8000/- per 251st Manufacturer Specs. Rs.12,000/- meeting not As per SRO Musidin by m/s provided by the / martin dow Firm. 1x10’s Pakistan Last inspection limited. report is dated 05-01-2009. Form 5 is not in order as per Rule 26 (1). Details of analytical
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method along with manufacturing method required. 512. -do- Obnack Form-5 Artimov-K by Deferred in Deferred for Tablet Dy. No: M/s Barret 255th meeting confirmation Each tablet contains: 2758 dated. Hodgson. for: of approval Diclofenac 23-06-2011 Commitment as status by potassium…100mg Rs.8000/- International per 251st reference regulatory (Anti rheumatoid) Rs.12,000/- availability not meeting not authorities Manufacturer Specs. As per SRO confirm. provided by the / Firm. 2x10’s Last inspection report is dated 05-01-2009. Label claim not clear. Form 5 is not in order as per Rule 26 (1). Undertakings/ Form 5 without signature. Method of manufacture and analytical specs required. 513. -do- Pantazob Capsule Form-5 Duzole by Deferred in Deferred for Capsule Dy. No: Goodman 255th meeting submission of Each capsule contains: 2709 dated. laboratories. for: source of Pantoprazole (As sodium 22-06-2011 International Commitment as pellets, fee sesquihydrate) ….40mg Rs.8000/- availability not per 251st and approval status by (Proton pump inhibitor) Rs.12,000/- confirm meeting not reference Manufacturer Specs. As per SRO provided by the authorities. / Firm. 2x7’s Last inspection report is dated 05-01-2009. Source of pellets and relevant documents not provided. Relevant specs required.
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Form 5 is not in order as per Rule 26 (1). 514. -do- Obfex tablet Form-5 MHRA Deferred in Approved Tablet Dy. No: 255th meeting Each tablet contains: 2710 dated. Allergia Tablets for: Fexofenadine HCl….120mg 22-06-2011 by M/s Mass Commitment as (anti Histamine) Rs.8000/- per 251st BP Specs. Rs.12,000/- meeting not As per SRO provided by the / Firm. 1x10’s Last inspection report is dated 05-01-2009. Label claim not clear. Detailed manufacturing method, specs and testing method required. Form 5 is not in order as per Rule 26 (1). 515. -do- Parox tablet Form-5 USFDA Deferred in Approved Tablet Dy. No: 255th meeting Each film coated tablet 2702 dated. Paraxyl Tablets for: contains: 22-06-2011 by M/s CCL Commitment as Paroxetine HCl……20mg Rs.8000/- per 251st (Anti depressant) Rs.12,000/- meeting not BP Specs. As per SRO provided by the / Firm. 1x10’s Last inspection report is dated 05-01-2009. Form 5 is not in order as per Rule 26 (1). Form 5 not signed. Label claim not clear. Manufacturing method and testing details
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required. 516. -do- Ofcin tablet Form-5 MHRA Commitment as Approved Tablet Dy. No: per 251st Each film coated tablet 2713 dated. Oflobid by m/s meeting not contains: 22-06-2011 Hilton provided by the Ofloxacin USP……400mg Rs.8000/- Firm. (anti biotic) Rs.12,000/- Form 5 is not in USP 37 Specs. As per SRO order as per / Rule 26 (1). 1x10’s Last inspection report is dated 05-01-2009. Label claim not clear. Testing specs required. Copy of official monograph required. 517. -do- Co-Meth Suspension Form-5 Co-Artesiane Commitment as Approved 15,90mg/5ml Dy. No: COMPANY: per 251st Suspension 2757 dated. Dafra Pharma meeting not Each 5ml contains: 23-06-2011 BELGIUM provided by the Artemether……………..15m Rs.8000/- Artem plus Firm. g 23-06-2011 By Hilton Last inspection Lumefentarine………..90mg Rs.12,000/- Arceva by report is dated (AntiMalarial) As per SRO Sami 05-01-2009. Manufacturer Specs. / Qmetem plus Detailed testing 10’s By Bosch method along with equipment list required. Form 5 not correct. Details of product specs required. Manufacturing equipment details required. But board has approved the same strength in 243rd meeting. 518. M/s Deftec 50mg Form-5 Galvus by M/s Deferred in Approved Rotexmedi Tablet Dy. No: 850 Novartis 254th meeting ca Each tablet contains: dated. Registered in for Pakistan Vildagliptin…..50mg 31-12-2010 MHRA Commitmen
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(Pvt) Ltd, (Dipeptidyl Peptidase-4 Rs.8,000/- Galvus t as per 251st Kahuta inhibitor Anti diabetic/ Oral 11-12-2013 (Novartis) meeting of Road Hypoglycemic) Rs:12000/- RB. Islamabad. Rotexmedica Specs. As per PRC/ Latest 28’s Inspection report. Differential fee. Stability Data as per guidelines approved by the board in 249th meeting. 519. M/s Vitanor-D Injection Form 5 Not provided Deferred in Approved Nortech 249th meeting of Pharmace Each 1ml ampoule contains:- Dy No 8988 Calciferol of RB for: uticals Colecalciferol………5mg dated 21-01- Global confirmation of (Pvt) 2014 Pharmaceutical formulation in Limited, (Vitamin-D Analogue) s Islamabad reference drug Islamabad. Rs.20,000 agencies. Ampoule/ BP N.B: Vial SVP As per SRO/ (Requirments of (General) 1mlx1’s TOC analyzer vide letter 1mlx5’s and Liquid No. F.6- Amp. Particle Counter 6/2014- shall be Lic (M- observed as per 237) dated decision of 14-10-14 Registration Board) 520. M/s K-CIT Tablet Each extended Form-5 Alvesco by M/s Initially case Approved ALLMED release Tablet contains: Dy. No: Takeda GMBH was deferred in (Private) Potassium Citrate…..10mEq 5139 dated. (USFDA) 254th meeting limited, (1080mg) (Alkalizing agent) 31-05-2012 Urocit-K by for:- sundar Manufacturer Specs Rs.8, 000/- M/s Universal Commitmen industrial dated. 11- enterprises. t as per estate, 10-2012 (039808) 251st Lahore Rs:12,000/ meeting of As per PRC/ RB. Latest Inspection report. Differential fee for Form
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5-D. Stability Data as per guidelines approved by the board in 249th meeting of RB. Again case was deferred in 256th meeting.
521. Martin Valiant Tablet 320mg Form-5 Diovan Deferred in Approved Dow Tablet Dy. No: 567 (Novartis 256th meeting Pharmace Each film coated tablet dated. Pharmaceutical for provision of uticals, contains: 30.04.2012 s Corp., US) Challan of Karachi Valsartan USP ….320mg Rs.8,000/- USFDA Differential Priority (Angiotensin II antagonist) 13.11.2013 fee not No. 1200 (Manufacturer’s specs) Rs.12,000/- Diovan attached. from 1560 Rs. (Novartis Latest after 1187.50/10’s Pharma inspection swapping 1662.50/14’s Pakistan report within 2375.00/20’s Limited) one year 3325.00/28’s Undertaking 3562.50/30’s as per 251st meeting of RB not provided.
522. -do- Valiant 40mg Form-5 Diovan Deferred in Approved Priority Tablet Dy. No: 565 (Novartis 256th meeting No. 1193 Each film coated tablet dated. Pharmaceutical for provision of from 1566 contains: 30.04.2012 s Corp., US) Challan of after Valsartan USP …. 40mg Rs.8,000/- USFDA Differential swapping (Angiotensin II antagonist) 13.11.2013 fee. (Manufacturer’s specs) Rs.12,000/- Valtec Lastest Rs. (Tabrose) inspection 235.27/10’s report 339.38/14’s Undertaking 470.54/20’s as per 251st 658.75/28’s meeting of 705.80/30’s RB.
523. -do- Diatrol Plus SR 1/500 Form-5 Amaryl M Deferred in Deferred for Priority Tablet Dy. No: (Sanofi Aventis 256th meeting confirmation
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No. 1452 Each Bi-Layer film coated 1391 dated. India) for provision of of approval from 1844 tablet contains: 27.08.2012 Approval status by after Glimepiride USP …. 1mg Rs.8,000/- Amaryl M status by reference swapping Metformin Hydrochloride (as 20.11.2013 (Sanofi refrence regulatory authorities sustained release) …. 500mg Rs.12,000/- Aventis) P.161 regulatory (Sulfonyl Urea + Biguanides) Rs. authorities. (Manufacturer’s specs) 100.00/10’s Challan of 200.00/20’s Differential 300.00/30’s fee not 600.00/60’s attached. Last inspection report is dated 26.02.2011. Undertaking as per 251st meeting of RB not provided.
524. -do- Diatrol Plus SR 2/500 Form-5 Amaryl M Deferred in Deferred for Priority Tablet Dy. No: (Sanofi Aventis 256th meeting confirmation No. 1453 Each Bi-Layer film coated 1397 dated. India) for provision of of approval from 1851 tablet contains: 27.08.2012 Approval status status by after Glimepiride USP …. 2mg Rs.8,000/- Amaryl M by refrence reference regulatory swapping Metformin Hydrochloride (as 20.11.2013 (Sanofi regulatory authorities sustained release) …. 500mg Rs.12,000/- Aventis) authorities. (Sulfonyl Urea + Biguanides) Rs. P.161 Challan of (Manufacturer’s specs) 180.00/10’s Differential fee 360.00/20’s not attached. 540.00/30’s Last inspection 1080.00/60’s report is dated 26.02.2011. Undertaking as per 251st meeting of RB not provided.
525. -do- Xyven Form-5 Seractil (Genus Deferred in Approved Priority Tablet Dy. No: 458 Pharmaceutical 256th meeting No. 1456 Each film coated tablet dated. s UK) BNF-67 for provision of from contains: 20.11.2013 Reference for after Dexibuprofen …. 300mg Rs.20,000/- Dexifen (ICI specs not swapping (Propionic Acid Derivatives) Rs. Pakistan provided. (Mfg. specs) 116.00/10’s Limited) p.846 Challan of
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222.60/20’s differential fee 318.00/30’s not attached. Last inspection report is dated 26.02.2011. Undertaking as per 251st meeting of RB not provided.
526. -do- Xyven Form-5 Seractil (Gebro Deferred in Approved Priority Tablet Dy. No: 459 Pharma 256th meeting No. 1454 Each film coated tablet dated. Germany) for provision of from 2727 contains: 20.11.2013 Approval status after Dexibuprofen …. 200mg Rs.20,000/- Dexifen (ICI by reference swapping (Propionic Acid Derivatives) Rs. Pakistan regulatory (Mfg. Specs) 79.20/10’s Limited) P.846 authorities. 151.20/20’s Reference for 216.00/30’s specs not provided. Challan of differential fee not attached. Last inspection report is dated 26.02.2011. Undertaking as per 251st meeting of RB not provided.
527. -do- Xyven Form-5 Seractil (Genus Deferred in Approved Priority Tablet Dy. No: 460 Pharmaceutical 256th meeting No. 1455 Each film coated tablet dated. s UK) BNF-67 for provision of from 2728 contains: 20.11.2013 Reference for after Dexibuprofen …. 400mg Rs.20,000/- Dexifen (ICI specs not swapping (Propionic Acid Derivatives) Rs. Pakistan provided. (Mfg. specs) 144.32/10’s Limited) Challan of 275.62/20’s p.846 differential fee 393.60/30’s not attached. Last inspection report is dated 26.02.2011. Undertaking as per 251st meeting of RB
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not provided.
528. -do- Tri-Amvel 5/160/25mg Form-5 Exforge HCT Deferred in Approved Priority Tablet Dy. No: 855 (Novartis 256th meeting No. 974 Each film coated tablet dated. Pharmaceutical for provision of from 1645 contains: 29.05.2012 s Corp. US) Reference for after Amlodipine (USP) …. 5mg Rs.8,000/- USFDA specs not swapping Valsartan (USP) … 160mg 20.11.2013 provided. Hydrochlorothiazide USP Rs.12,000/- Exforge HCT Challan of …25mg Rs. (Novartis differential fee (Angiotensin II antagonist + 848.21/10’s Pharma not attached. Calcium channel blocker + 1187.50/14’s Pakistan Ltd) Last inspection Thiazide diuretic) 1696.43/20’s p.413 report is dated (USP Specs.) 2375.00/28’s 26.02.2011. 2544.64/30’s Undertaking as per 251st meeting of RB not provided.
529. -do- Tri-Amvel 10/320/25mg Form-5 Exforge HCT Deferred in Approved Priority Tablet Dy. No: 850 (Novartis 256th meeting No. 1028 Each film coated tablet dated. Pharmaceutical for provision of from contains: 29.05.2012 s Corp. US) Reference for 1634 after Amlodipine (USP) …. 10mg Rs.8,000/- USFDA specs not swapping Valsartan (USP) … 320mg 20.11.2013 provided. Hydrochlorothiazide USP Rs.12,000/- Exforge HCT Challan of …25mg Rs. (Novartis differential fee (Angiotensin II antagonist + 1245.54/10’s Pharma not attached. Calcium channel blocker + 1743.75/14’s Pakistan Ltd) Last inspection Thiazide diuretic) 2491.07/20’s p.413 report is dated (USP Specs.) 3487.50/28’s 26.02.2011. 3736.61/30’s Undertaking as per 251st meeting of RB not provided.
530. -do- Tri-Amvel 10/160/25mg Form-5 Exforge HCT Deferred in Approved Priority Tablet Dy. No: 854 (Novartis 256th meeting No. 1027 Each film coated tablet dated. Pharmaceutical for provision of from 1633 contains: 29.05.2012 s Corp. US) Reference for after Amlodipine (USP) …. 10mg Rs.8,000/- USFDA specs not swapping Valsartan (USP) … 160mg 20.11.2013 provided. Hydrochlorothiazide USP Rs.12,000/- Exforge HCT Challan of …25mg Rs. (Novartis differential fee (Angiotensin II antagonist + 910.71/10’s Pharma not attached. Calcium channel blocker + 1275.00/14’s Pakistan Ltd) Last inspection
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Thiazide diuretic) 1821.43/20’s p.413 report is dated (USP Specs.) 2550.00/28’s 26.02.2011. 2732.14/30’s Undertaking as per 251st meeting of RB not provided.
531. -do- Tri-Amvel 10/160/12.5mg Form-5 Exforge HCT Deferred in Approved Priority Tablet Dy. No: 851 (Novartis 256th meeting No. Each film coated tablet dated. Pharmaceutical for provision of 1006 from contains: 29.05.2012 s Corp. US) Reference for 1636 Amlodipine (USP) …. 10mg Rs.8,000/- USFDA specs not after Valsartan (USP) … 160mg 20.11.2013 provided. swapping Hydrochlorothiazide USP Rs.12,000/- Exforge HCT Challan of …12.5mg Rs. (Novartis differential fee (Angiotensin II antagonist + 906.25/10’s Pharma not attached. Calcium channel blocker + 1268.75/14’s Pakistan Ltd) Last inspection Thiazide diuretic) 1812.50/20’s p.413 report is dated (USP Specs.) 2537.50/28’s 26.02.2011. 2718.75/30’s Undertaking as per 251st meeting of RB not provided.
532. -do- Tri-Amvel 5/160/12.5mg Form-5 Exforge HCT Deferred in Approved Priority Tablet Dy. No: 852 (Novartis 256th meeting No. 973 Each film coated tablet dated. Pharmaceutical for provision of from contains: 29.05.2012 s Corp. US) Reference for after 1637 Amlodipine (USP) …. 5mg Rs.8,000/- USFDA specs not swapping Valsartan (USP) … 160mg 20.11.2013 provided. Hydrochlorothiazide USP Rs.12,000/- Exforge HCT Challan of …12.5mg Rs. (Novartis differential fee (Angiotensin II antagonist + 843.75/10’s Pharma not attached. Calcium channel blocker + 1181.18/14’s Pakistan Ltd) Last inspection Thiazide diuretic) 1687.50/20’s p.413 report is dated (USP Specs.) 2362.50/28’s 26.02.2011. 2531.25/30’s Undertaking as per 251st meeting of RB not provided.
533. -do- Co-Valiant 320/12.5mg Form-5 Diovan HCT Deferred in Approved Priority Tablet Dy. No: 570 (Novartis 256th meeting No. 1086 Each film coated tablet dated. Pharmaceutical for provision of from 1560 contains: 30.04.2012 s Corp., US) Confirmation of after Valsartan USP …. 320mg Rs.8,000/- USFDA me too status.
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swapping Hydrochlorothiazide 13.11.2013 Reference for USP…12.5mg Rs.12,000/- specs not (Angiotensin II antagonist + Rs. provided. Thiazide diuretic) 1785.71/10’s Challan of (USP Specs.) 2500.00/14’s differential fee 3571.43/20’s not attached. 5000.00/28’s Last inspection 5357.14/30’s report is dated 26.02.2011. Undertaking as per 251st meeting of RB not provided. Complete method of manufacturing not provided. 534. -do- Co-Valiant 160/12.5mg Form-5 Diovan HCT Deferred in Approved Priority Tablet Dy. No: 573 (Novartis 256th meeting No. 1063 Each film coated tablet dated. Pharmaceutical for provision of from contains: 30.04.2012 s Corp., US) Reference for 1561after Valsartan USP …. 160mg Rs.8,000/- USFDA specs not swapping Hydrochlorothiazide USP… 13.11.2013 provided. 12.5mg Rs.12,000/- Co-Diovan Challan of (Angiotensin II antagonist + Rs. (Novartis differential fee Thiazide diuretic) 892.66/10’s Pharma not attached. (USP Specs.) 1250.00/14’s pakistan Last inspection 1785.71/20’s Limited) p.413 report is dated 2500.00/28’s 26.02.2011. 2678.57/30’s Undertaking as per 251st meeting of RB not provided. Complete method of manufacturing not provided.
535. -do- Co-Valiant 160/25mg Form-5 Diovan HCT Deferred in Approved Priority Tablet Dy. No: 572 (Novartis 256th meeting No. 1085 Each film coated tablet dated. Pharmaceutical for provision of from 1565 contains: 30.04.2012 s Corp., US) Reference for after Valsartan USP …. 160mg Rs.8,000/- USFDA specs not swapping Hydrochlorothiazide USP… 13.11.2013 provided. 25mg Rs.12,000/- Co-Diovan Challan of
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(Angiotensin II antagonist + Rs. (Novartis differential fee Thiazide diuretic) 901.79/10’s Pharma not attached. (USP Specs.) 1262.50/14’s pakistan Last inspection 1803.57/20’s Limited) p.413 report is dated 2525.00/28’s 26.02.2011. 2705.36/30’s Undertaking as per 251st meeting of RB not provided. Complete method of manufacturing not provided. 536. -do- Esomax Insta 40mg Form-5 ------Deferred in Rejected as Priority Capsules Dy. No: 849 256th meeting the No. 1062 Each capsule contains: dated. Ezocarb for provision of formulation from 1635 Esomeprazole (as magnesium 29.05.2012 (Pray’s RB has deferred is not after trihydrate) USP ………... Rs.8,000/- Pharmaceutical) the same in approved by swapping 40mg 20.11.2013 250th meeting reference Sodium Bicarbonate USP Rs.12,000/- for expert regulatory ………… 1100mg Rs. opinion. authorities (Proton pump inhibitor + 203.36/10’s Reference for Antacid) 284.70/14’s specs not (Reference for specs not 406.71/20’s provided. provided) 610.07/30’s Challan of differential fee not attached. Last inspection report is dated 26.02.2011. Undertaking as per 251st meeting of RB not provided.
537. -do- Esomax Insta 20mg Form-5 ------Deferred in Rejected as Priority Capsules Dy. No: 847 256th meeting the No. 1050 Each capsule contains: dated. Ezocarb for provision of formulation from 1638 Esomeprazole (as magnesium 29.05.2012 (Pray’s RB has deferred is not after trihydrate) USP ………... Rs.8,000/- Pharmaceutical) the same in approved by swapping 20mg 20.11.2013 250th meeting reference Sodium Bicarbonate USP Rs.12,000/- for expert regulatory ………… 1100mg Rs. opinion. authorities (Proton pump inhibitor + 135.57/10’s Reference for Antacid) 189.80/14’s specs not (Reference for specs not 271.14/20’s provided.
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provided) 406.71/30’s Challan of differential fee not attached. Last inspection report is dated 26.02.2011. Undertaking as per 251st meeting of RB not provided.
538. -do- Viglip-M Form-5 Eucreas Deferred in Approved Priority Tablets Dy. No: 376 (Novartis 256th meeting No. 926 Each film coated tablet dated. Pharmaceutical for provision of from 1085 contains: 28.05.2011 s UK Ltd.) Challan of after Vildagliptin ……. 50mg Rs.8,000/- MHRA differential fee swapping Metformin HCl……… 31.07.2013 not attached. 850mg Rs.12,000/- Galvus Met Commitment as (Anti Hyperglycemic) Rs. (Novartis per 251st (Mfg. specs) 773.30/10’s Pharma (PAK) meeting not 2319.90/30’s Ltd) p.170 provided. Inspection report is dated 26.02.2011. Covering letter and fee Challan of Rs:8000/- is for Viglip-M 50/1000mg. Reference for specs not provided. 539. -do- Tirace 100mg/ml Form-5 Keppra (UCB Deferred in Approved Priority Oral solution Dy. No: 632 Pharma Ltd.) 256th meeting with change No. 1451 Each ml contains: dated. USFDA for provision of of name. from 1455 Levetiracetam ……. 100mg 27.12.2011 Reference for after (Antiepileptic) Rs.8,000/- Lerace (Hilton specs not swapping (USP specs.) 31.07.2013 Pharma Pvt provided. Rs.12,000/- Ltd.) p.984 Challan of Rs. differential fee 88.40/10ml not attached. 247.00/30ml Last inspection 468.00/60ml report is dated 936.00/120 26.02.2011. ml Undertaking as per 251st
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meeting of RB not provided. Complete method of manufacturing not provided. 540. -do- Tirace 250mg Form-5 Keppra (UCB Deferred in Approved Priority Tablets Dy. No: 395 Pharma Ltd.) 256th meeting with change No. 1426 Each film coated tablet dated. USFDA for provision of of name. from 1413 contains: 28.10.2011 Reference for after Levetiracetam ……. 250mg Rs.8,000/- Lerace (Hilton specs not swapping (Antiepileptic) 31.07.2013 Pharma Pvt provided. (USP specs.) Rs.12,000/- Ltd.) p.984 Challan of Rs. differential fee 340.60/10’s not attached. 681.20/20’s Last inspection 1021.80/30’s report is dated 26.02.2011. Undertaking as per 251st meeting of RB not provided. Complete method of manufacturing not provided. 541. -do- Tirace 750mg Form-5 Keppra (UCB Deferred in Approved Priority Tablets Dy. No: 517 Pharma Ltd.) 256th meeting with change No. 1427 Each film coated tablet dated. USFDA for provision of of name. from 1412 contains: 16.11.2011 Reference for after Levetiracetam ……. 750mg Rs.8,000/- Lerace (Hilton specs not swapping (Antiepileptic) 31.07.2013 Pharma Pvt provided. (USP specs.) Rs.12,000/- Ltd.) p.984 Challan of Rs. differential fee 1044.00/10’s not attached. 2088.00/20’s Last inspection 3132.00/30’s report is dated 26.02.2011. Undertaking as per 251st meeting of RB not provided. Complete method of manufacturing not provided.
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542. -do- Tirace 1000mg Form-5 Keppra (UCB Deferred in Approved Priority Tablets Dy. No: 397 Pharma Ltd.) 256th meeting with change No. 1432 Each film coated tablet dated. USFDA for provision of of name. from 1411 contains: 28.10.2011 Confirmation of after Levetiracetam ……. 1000mg Rs.8,000/- Keppra (GSK me too status. swapping (Antiepileptic) 31.07.2013 Pakistan) Reference for (USP specs.) Rs.12,000/- specs not Rs. provided. 942.50/10’s Challan of 1885.00/20’s differential fee 2827.50/30’s not attached. Last inspection report is dated 26.02.2011. Undertaking as per 251st meeting of RB not provided. Complete method of manufacturing not provided. 543. do- Zivaro 20mg Form-5-D Xarelto Case was Approved. Priority Tablets Dy. No: 666 (Janssen deferred in list Each film coated tablet dated. Pharms) 256th meeting No.1562 contains: 16.02.2012 USFDA for:- after Rivaroxaban ……. 20mg Rs.8,000/- Reference for 1505 after (Anti thrombic agent) 13.11.2013 Xarelto (Bayer specs not swapping (Mfg Specs.) Rs.12,000/- Health Care) provided. Rs. P.268 Challan of 9680.00/5’s differential fee 19360.00/10 not attached. ’s Last inspection 38720.00/20 report is dated ’s 26.02.2011. 58080/30’s Undertaking as per 251st meeting of RB not provided. Approval Status in SRAs not confirmed. Stability studies as per 249th meeting of RB required.
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544. M/s Hytrex 250mg Injection IV Form-5 Rocephin Deferred for Approved. Hygeia Injection Dy. No: Injection 250 Commitmen Pharmace Each Injection contains: 1107 dated. mg t as per 251st uticals, Ceftriaxone 24-02-2015 By m/s Martin meeting of Plot # 295, sodium……250mg Rs.20,000/- Dow RB. Industrial (Cephalosporin) As per SRO/ Pharmaceutical Readable Triangle, (USP Specs) 250mg s- Karachi. latest Kahuta USFDA inspection Road, report. Islamabad. 545. -do- Hyclin Gel Form-5 Benzaclin by Deferred for Approved. Gel Dy. No: M/s Valeant Commitmen Each tube contains: 1106 dated. Barmuda t as per 251st Clindamycin Phosphate eq to 24-02-2015 (USFDA) meeting not clindamycin……………….1 Rs.20,000/- Clinda Plus By provided by % As per SRO/ M/s Valor the Firm. Benzoyl Peroxide…….. 5.0% 10gm Pharmaceutical Readable (Anti bacterial, topical) s. latest (Manufacturer Specs.) inspection report. Justification for Quantity of active in master formulation. 546. -do- Hyvir Cream Form-5 Clovirex Deferred for Approved. Cream Dy. No: Topical by M/s Commitmen Each Tube contains: 1109 dated. Brooks Pharma. t as per 251st Acyclovir…….5.0% 24-02-2015 Acyclovir meeting. Anti viral Rs.20,000/- (Amneal Readable Manufacturer Specs. As per SRO/ Pharms) latest 10gm USFDA inspection report. Specific tests related to acyclovir ointment. 547. M/s. Zupenth IM Form 5 Not confirmed Deferred in Deferred for Shrooq Injection in Stringent 245th meeting confirmation Each ml contains:- 31-3-2014 of approval Pharmacet Zuclopenthixol Decanoate DRA,s for international uicals (617) availability & status in (B.P)……..50mg Rs.20,000/ reference (Pvt) Ltd., (Typical antipsychotic drug of Clopixol confirmation of authorities 21-Km thioxanthene class) As Per Acuphase Particulate (B.P Spec.s) for same unit Ferozepur SRO/1×2ml Injection counter. volume. Road, ampoule (Lundbeck)
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Lahore. Additional Grant of additional Sections sections recommended. (11- granted 12-2013) vide letter No. F.6- 1. TOC anlayzer 2/2013- and liquid Lic (M- particle counter are 233) dated under the 07-04- process of 2014 procurement 2. International availability in stringent DRA,s not confirmed. Firm provided reference of India for proof of international availability. 548. M/s Atco TROZET Tablet Form-5A Femara of Deferred for: Approved. Pharma Novartis Legalized Firm will Internation Each film coated tablet Dy. No. 77 (USFDA) COPP. provide valid al (Pvt) contains: dated 16-10- Sole agency legalized Limited, Letrozole USP……2.5mg 08 Femara of CoPP as agreement. present has Karachi Novartis Drug sale been expired. Nonsteroidal Aromatase 15000 dated Pakistan license. Dabur Inhibitor 16-10-08 Pharma 85000 dated Limited, USP 13-12-2013 Village Kishanpur Rs. 8139 a PO Guru Pack of 28’s Majra Tehsil Nalagarah Distt. India. (Import case) 549. M/s Fentanyl Sandoz 25ug/h Form-5A DURAGESIC- COPP issued on Approved. Novartis (10.5cm2) Dy. No: 45 25 by M/s 12 October Pharma Transdermal Patch dated. JANSSEN 2011. (Pakistan), Each transdermal Patch 25-01-2012 PHARMS GMP certificate Limited, contains: Rs.15000/- dated. 27-01- Karachi. Fentanyl 21-01-2012 2012
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…...... 25ug/hour Rs.85,000/- Label (Cancer Pain/Pain dated 25-03- information in Manufact Managment) 2014 Urdu not urer:- Manufacturer Specs MRP Rs:- provided. Hexal 4227.00 / NOTE: - firm AG, (Dermal Route) 5’s has attached Industries request from 25 83607, different Holzkirch hospital e.g. en, SKMCH&RC, Germany. Lahore, Dr. Ziauddin Hospital Karachi, JPMC Karachi, PAEC MINAR Multan and from different doctors to provide alternative to Duragesic Patches (as Duragesic is short in market) for management of moderate to severe chronic pain. Deferred and will be considered on its turn 550. M/s Fentanyl Sandoz 50ug/h Form-5A DURAGESIC- COPP issued on Approved. Novartis (21cm2) Dy. No: 46 25 by M/s 12 October Pharma Transdermal Patch dated. JANSSEN 2011. (Pakistan), Each transdermal Patch 25-01-2012 PHARMS GMP certificate Limited, contains: Rs.15000/- dated. 27-01- Karachi. Fentanyl 21-01-2012 2012 …...... 50ug/hour Rs.85,000/- Label Manufact (Cancer Pain/Pain dated 25-03- information’s in urer:- Managment) 2014 Urdu not Hexal Manufacturer Specs MRP Rs:- provided. AG, 2280.00 / NOTE:- firm Industries (Dermal Route) 5’s has attached 25 83607, request from
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Holzkirch different en, hospital e.g. Germany. SKMCH&RC, Lahore, Dr. Ziauddin Hospital Karachi, JPMC Karachi, PAEC MINAR Multan and from different doctors to provide alternative to Duragesic Patches (as Duragesic is short in market) for management of moderate to severe chronic pain. Deferred and will be considered on its turn. Deferred and will be considered on its turn
Deferred cases of Tamsulosin pellets Manufactured by M/s Vision Pharmaceuticals, Islamabad.
M/s Vision Pharmaceuticals, Plot No 22-23, Kahuta Road, Islamabad has submitted the request that approximately four products containing Tamsulosin Pellets as API (source M/s Vision Pharma) were deferred in 255th meeting with comments as following; “Deferred for clarification as same qualified persons (QCM and QC analyst) of M/s. Vision Pharmaceuti cals kahuta Road facility and I-10 facility signed documents of for both facilities.” Firm submitted clarification that Miss Humera Iqbal was QCM at Vision Pharmaceutical I-10/3 Islamabad when we were manufacturing pellets at this facility (DML NO. 000517 issued/renewed on 01.04.2014 copy attached) and she joined new facility at Kahuta Road, Islamabad (DML No.000806 issued on 02.12.2014 copy attached) when we started pellets
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manufacturing on this new facility. Further they submitted that R&D of pellets is under supervision of Miss Humara. Cases were may be deferred due to some misunderstanding. They requested on the basis of above clarification that deferred cases may be considered on priority basis to avoid financial loss to M/s vision Pharmaceuticals and movement of capital abroad. Following deferred cases are submitted for consideration of RB.
551. M/s Aulton Capsule Tamsin 0.4mg Form 5 MHRA Approved Pharmaceutical Each Hard Gelatin Capsule Rs. 20,000/- approved s, Plot # 84/1, contains: vide Dy. No. Galebon Block – A, Pellets of Tamsulosin HCl 3774 dated 02- (Consilient, Phase 5, USP eq to Tamsulosin 0.4mg 11- 2015 Pack Ireland) Industrial Estate, size of 1 x 10’s / Hattar. Source of Tamsulosin HCl as per price fixed Uroflo SR pellets 0.2% M/s by Government (Novartis) VisionPharmaceuticals, Plot#22, Industrial Triangle Kahuta Road, Islamabad. selective α1 receptor antagonist (Manufacture Specification) 552. M/s UDL Flow up 400mcg Capsule Form 5 Flowmax FDA Approved Pharma, # 44-45 Each capsule contains:- 24-12-2014 North West SR pellets OF Tamsulosin (352) Rs.20,000/- Maxflow Industrial Zone, Hydrochloride…400 mcg Rs. 35.00 per (CCL) Port Qasim, (Alpha 1a antagonist) capsule Rs. 350 Pakistan. Source of Pellets M/s Vision per 10’s Pharma, I-10, Islamabad 553. Jenner Sulsin Capsules 0.4mg Form 5 Flomax Approved Pharmaceuticals Each Capsule Contains: Diary Date Capsules USA (Pvt.) Ltd. Plot # Tamsulosin Hydrochloride 28.08.15 and Japan 3, M2- Pharma 0.4mg (Pellets) Rs: 20000.00 Astellas Pharma Zone, 26KM, (Alfa 1-a blocker) dated 18.08.15 MHRA, FDA LahoreSharikpur USP Specs. As per SRO 10’s Road, Pellets source: Vision Maxflow Cap Shaikhupura – Pharmaceuticals, Islamabad (CCL) Pakistan
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Deferred Case of M/s Bajwa Sons Following products of M/s Bajwa Sons, 129 Circular Road, Lohari Lahore are deferred in the 246th and 251st meetings of Registration Board due to below mentioned reasons. The firm submitted documents in this respect and case was presented in 256th meeting with details below. Decision of the RB in 256th meeting is “Decision: Deferred for presentation of dossiers in the next board meeting.”
S/N Name and Brand Name Type of Reason for Decision address of (Proprietary name + Form which manufacturer Dosage Form + Deferred. / Applicant Strength) Initial date, diary Composition Fee Pharmacological including Group differential fee Finished product Specification Demanded Price / Pack size 554. Applicant Famous Brand Single Form-5A Product was Rejected M/s Bajwa Blood Bags Deferred in a. for the Sons, 129 Dy No: Not 251st meeting submission of Circular Road, provided for COPP issued Lohari Lahore Each 100ml of CPDA submission of by the manufacturer (Citrate Phosphate 15000/- following: instead of Manufacturer Dextrose Adenine dated 08- relevant Shanghai Solution, Anticoagulant) 10-10 1. COPP with authority. Transfusion contains: complete b. Single page Technology Citric acid Rs 150/ presentation stability Co. Ltd. monohydrate……0.299g Blood Bag of applied report is Add: No.500 Sodium citrate of 250ml product. submitted in You Dong dihydrate…………2.63g Rs 150/ 2. Stability which the Road, Sodium biphosphate Blood Bag data with firm informed Minhang, monohydrate……0.222g of 450ml details of that 12 Shanghai, Dextrose Rs 160/ physical samples with anticoagulants 201100, P.R monohydrate……..3.19g Blood Bag chemical and of year 2002 of China Adenine……….0.0275g of 500ml biological and 21 Water for Injection….Qs test. samples of 3. Packaging blood bags in Disposable material 2005 tested. specifications. And the
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samples qualified the physical, chemical, biological tests. c. Packaging material specifications are not submitted 555. Applicant Famous Brand Double Form-5A Product was Rejected M/s Bajwa Blood Bags Deferred in a. for the Sons, 129 Dy No: 29 251st meeting submission of Circular Road, Each 100ml of CPDA dated 08- for COPP issued Lohari Lahore (Citrate Phosphate 10-10 submission of by the manufacturer Dextrose Adenine following: instead of Manufacturer Solution, Anticoagulant) 15000/- relevant Shanghai contains: dated 08- 1. COPP with authority. Transfusion Citric acid 10-10 complete b. Single page Technology monohydrate……0.299g presentation stability Co. Ltd. Sodium citrate Rs 300/ of applied report is Add: No.500 dihydrate…………2.63g Blood Bag product. submitted in You Dong Sodium biphosphate of 450ml 2. Stability which the Road, monohydrate……0.222g Rs 315/ data with firm informed Minhang, Dextrose Blood Bag details of that 12 Shanghai, monohydrate……..3.19g of 500ml physical samples with anticoagulants 201100, P.R Adenine……….0.0275g chemical and of year 2002 of China Water for Injection….Qs biological and 21 test. samples of Disposable 3. Packaging blood bags in material 2005 tested. specifications. And the samples qualified the physical, chemical, biological tests. c. Packaging material specifications are not submitted 556. Applicant Famous Brand triple Form-5A Product was Rejected M/s Bajwa Blood Bags Deferred in a. for the Sons, 129 Dy No: Not 251st meeting submission of Circular Road, Each 100ml of CPD provided for COPP issued by the Minutes for 257th Registration Board Meeting 201
Lohari Lahore (Citrate Phosphate submission of manufacturer Dextrose Solution, 15000/- following: instead of Manufacturer Anticoagulant) dated 08- relevant Shanghai contains: 10-10 1. COPP with authority. Transfusion Citric acid complete b. Single page stability Technology monohydrate……0.299g Rs 510/ presentation report is Co. Ltd. Sodium citrate Blood Bag of applied submitted in Add: No.500 dihydrate…………2.63g of 450ml product. which the You Dong Sodium biphosphate Rs 525/ 2. Stability firm informed Road, monohydrate……0.222g Blood Bag data with that 12 Minhang, Dextrose of 500ml details of samples with Shanghai, monohydrate……..3.19g physical anticoagulants 201100, P.R Water for Injection….Qs chemical and of year 2002 of China to 100ml biological and 21 test. samples of Each 100ml of SAGM 3. Packaging blood bags in 2005 tested. (Saline Adenine Glucose material And the Mannitol, Red Blood specifications. samples Cell Preservative) qualified the contains: physical, Dextrose chemical, monohydrate…..0.900g biological Sodium tests. chloride…..0.877g c. Packaging Adenine…….0.0169g material D-Mannitol…….0.525g specifications Water for Injection….qs are not submitted to 100ml
Disposable 557. Applicant Famous Brand Form-5A Product was Rejected M/s Bajwa Quadruple Double Deferred in a. for the Sons, 129 Blood Bags Dy No: Not 251st meeting submission of Circular Road, provided for COPP issued Lohari Lahore Each 100ml of CPD submission of by the manufacturer (Citrate Phosphate 15000/- following: instead of Manufacturer Dextrose Solution, dated 08- relevant Shanghai Anticoagulant) 10-10 1. COPP with authority. Transfusion contains: complete b. Single page Technology Citric acid Rs 440/ presentation stability Co. Ltd. monohydrate……0.299g Blood Bag of applied report is Add: No.500 Sodium citrate of 450ml product. submitted in You Dong dihydrate…………2.63g Rs 445/ 2. Stability which the Road, Sodium biphosphate Blood Bag data with firm informed Minhang, monohydrate……0.222g of 500ml details of that 12 Shanghai, Dextrose physical samples with anticoagulants
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201100, P.R monohydrate……..3.19g chemical and of year 2002 of China Water for Injection….Qs biological and 21 to 100ml test. samples of 3. Packaging blood bags in Each 100ml of SAGM material 2005 tested. And the (Saline Adenine Glucose specifications. samples Mannitol, Red Blood qualified the Cell Preservative) physical, contains: chemical, Dextrose biological monohydrate…..0.900g tests. Sodium c. Packaging chloride…..0.877g material Adenine…….0.0169g specifications D-Mannitol…….0.525g are not Water for Injection….qs submitted to 100ml
Disposable
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Muhammad Amin, DDC (PEC) Replies of deferred applications of previous firms
Registration of Aprovasc Range (Irbesartan + Amlodipine).
Drug Registration Board in its 245th meeting discussed following products of M/s Sanofi Aventis, Karachi and advised the firm to provide status about availability of products in SRAs and provide safety and efficacy data of the drugs along with complete clinical trial data of these formulations.
S. No Name of drug(s) & Composition
558. Aprovasc 300/10mg Tablet Each tablet contains: Irbesartan……….300 mg Amlodipine besylate.14 mg eq. to amlodipine…10 mg (Alntihypertensive, angiotensin II receptor antagonist) 559. Aprovasc 150/10mg Tablet Each tablet contains: Irbesartan……….150 mg Amlodipine besylate.14 mg eq. to amlodipine…10 mg (Alntihypertensive, angiotensin II receptor antagonist) 560. Aprovasc 150/5mg Tablet Each tablet contains: Irbesartan……….150 mg Amlodipine besylate.7 mg eq. to amlodipine……5 mg (Alntihypertensive, angiotensin II receptor antagonist) 561. Aprovasc 300/5mg Tablet Each tablet contains: Irbesartan……….300 mg Amlodipine besylate.7 mg eq. to amlodipine……5 mg (Alntihypertensive, angiotensin II receptor antagonist)
In response, the firm had submitted that the fixed dose combination of Irbesartan + Amlodipine (in the strength of Irbesartan 100mg /Amlodipine 5mg and Irbesartan 100mg /Amlodipine 10 mg) is registered with PMDA Japan by the name of AIMIX by Daipinppon Suitomo Pharma. They have submitted that as the dosing in Japan is considerably lower than the USA or Europe therefore the fixed dose combinations are of lower strength.
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They have informed that that three Bioequivalence studies have been conducted for Aprovasc and the results of these had been submitted to DRAP for review and these studies show that the combination of Irbesartan + Amlodipine versus free individual molecule is safe and well tolerated. Apart from these 2 randomized, open-label, multicenter, phase III trials were conducted and published in peer reviewed index Journal, Clinical therapeutics (2012) and no untoward side effects were observed with this combination other than those already reported for the individual drugs. Registration Board in its 249th meeting discussed the case in view of the submission made by the firm and following decision was taken: “Registration Board referred the clinical data to Pharmacy Services Division for evaluation.”
Division of Pharmacy Services has now submitted evaluation report as under:
“The clinical study data attached by the company have been studied. The pharmacokinetic, Pharmacovigilance, safety, efficacy data provided by the company was evaluated. The representatives of the company who are involved in clinical research were asked to explain the need of combination medicines and their beneficial effects on hypertension patients. The research articles, studies carried out on the above combination medicine provided by the company and the discussion made with the expert reveals that the products could be approved for registration. Such combination products with Amlodipine and valsartan are already available in the market. The products may be considered by the Registration Board after completing other required codal formalities”
Decision: Registration Board deferred the case for detailed deliberation in the light of report of Pharmacy Sevices Division.
Registration Applications of M/s Stallion Pharma, Lahore deferred in 243rd meeting of registration board.
Registration Board in its 243rd meeting discussed following registration applications of M/s Stallion Pharma, Lahore and decided as follows:
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Sr No. 1. Brand Name Demanded 1.Type of Me-too Decision 243rd 2. Dosage Form Price / Pack Form status/ Int meeting 3. Composition size 2. Type of availability 4. Finished Product application specifications 3. Initial date, diary. 4. Date on which fee becomes complete according to type of application /or Form (total Fee) 562. Meropen Rs. Form-5 MERREM Deferred for Injection 500mg 1230.0/1’s, 500 mg confirmation of (USP) Rs. 25-10-2013 US FDA manufacturing 12300.0/10’s 645 R&I facility Dry Powder Meronem Injection Rs. 500 mg Each vial 20,000/- ICI contains: Pakistan Meropenem (USP)…500mg N/A (New (Penicillin) License) USP Specifications 563. Meropen Rs. Form-5 MERREM Deferred for Injection 1gm 2300.0/1’s, 1 g confirmation of (USP) Rs. 25-10-2013 US FDA manufacturing 23000.0/10’s 636 R&I facility Dry Powder Meronem Injection Rs. 1 g 20,000/- ICI Each vial Pakistan contains: Meropenem N/A (New (USP)…1gm License) (Penicillin) USP Specifications 564. Primaxin Rs. Form-5 PRIMAXIN Deferred for Injection (USP) 1230.0/1’s, IV confirmation of
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Rs. 25-10-2013 500 / 500 manufacturing Dry Powder 12300.0/10’s 632 R&I mg Vial facility Injection US FDA Each Vial Rs. contains: 20,000/- STANEM Imipenem 500 / 500 (BP)….…500mg mg Cilastatin Sodium Cirin (BP) eq. to Pharma Cilastatin ……500mg N/A (New (Penicillin) License) USP Specifications 565. Erapen Injection Rs. 3,500/- Form-5 INVANZ Deferred for 1 g (Stallion 1’s 1 g confirmation of Specs) Rs. 35,000/- 17-03-2014 US FDA manufacturing 10’s 450 R&I facility Dry powder INVANZ injection Rs,20,000/- 1 g Each vial OBS contains: Ertapenem N/A (New Sodium License) (Manufacturers specs) eq. to Ertapenem …… 1 g (Penicillin) Manufacturers’ Specifications
The firm has now developed separate areas for manufacturing of Carbapenem drugs and requested for registration.
Decision: Registration Board approved the products of the firm as the CLB has granted approval of Carbapenem Area. Further, status of all other registered Carbapenem drugs that have been granted a grace period for development of dedicated areas shall also be brought into the notice of the Board.
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Registration Applications of M/s Gallop Water Sciences, Lahore deferred in 253rd meeting of registration board.
Following applications of M/s Gallop Water Sciences, Lahore were deferred in 253rd meeting of registration board
1. G-SOL PAEDS Form-5 • Int availability Deferred for IV Infusion Dy. No: 3472 not confirmed. confirmation of Each 100ml contains: dated 18-05- Me-too: Macsol approval by Dextrose 2015 Paeds of M/s Mac reference anhydrous….4.3g 20,000/- & Rains Lahore. regulatory Sodium Rs.50/- Rs.40/- authority. Chloride……..0.18g 500ml, 200ml Caloric & Electrolytic solution 2. G-Lyte M Form-5 Internationally, Deferred for IV Infusion Dy. No: 3473 not available in confirmation of Each 100ml contains: dated 18-05- this strength. approval by Sodium 2015 Me-too: reference Chloride……..0.216gm 20,000/- regulatory Plabolyte-M of authority. Potassium Rs.100/- M/s Otsuka, Chloride…..1.5gm Rs.70/- Karachi Calcium Chloride 2 H2O 1000ml, 500ml, …..…0.022 Sodium Acetate 3 H2O …0.313gm Dextrose………..5.0gm Electrolytic & Caloric solution 3. Mannitol Form-5 Internationally Deferred for IV Infusion Dy. No: 3458 Not available in confirmation of Each 100ml contains: dated 18-05- this strength approval by Mannitol…….17.5gm 2015 Me-too: Mactol reference Sorbitol…….2.5gm 20,000/- regulatory of M/s Mac & authority. Osmotic diuetic Rs.200/- 500ml Rains, Lahore
Subsequently the firm requested for replacement of above applications with the following new ones which were presented in 255th meeting of the board. Case was decided as follows:
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566. G-SOL 10% Form 5 Otsuka The Board deferred the Rs. 20,000/- Japan application for Each 100 ml contains vide Dy. No. formulation clarification whether the Dextrose anhydrous 10gm 1140 dated 06- (Pladix) firm wants to withdraw 11-2015 their previously deferred Caloric solution FDA application in view of the (Manufacture Pack size of approved newly submitted Specification) 1000ml / 70 Dextrose applications or otherwise. PKR 10%
Medisol 10% (Medipak)
567. G-SOL 5% Form 5 Otsuka The Board deferred the Rs. 20,000/- Japan application for Each 100 ml contains vide Dy. No. formulation clarification whether the Dextrose anhydrous 5gm 1140 dated 06- (Pladix) firm wants to withdraw 11-2015 their previously deferred Caloric solution FDA application in view of the (Manufacture Pack size of approved newly submitted Specification) 500ml / 55 Dextrose applications or otherwise. PKR 5%
Medisol 5% (Medipak)
568. G-Sol RL 500 ml Form 5 MHRA The Board deferred the Rs. 20,000/- approved application for Each 100 ml contains vide Dy. No. clarification whether the Sodium Chloride 0.60gm 1141 dated 06- firm wants to withdraw Potassium Chloride 11-2015 Medisol their previously deferred 0.04gm Hartmann application in view of the Calcium Chloride Pack size of IV infusion newly submitted 0.027gm 500ml / 56 (Medisol ) applications or otherwise. Sodium lactate 0.32 gm PKR
Electrolyte Solution (Manufacture
Minutes for 257th Registration Board Meeting 209
Specification)
The firm has now requested that the registration of the products deferred in 253rd meeting may be considered in routine as per DRAP Policy and two products listed 2 and 3 above may be processed on priority basis against the quota of ten products per section. Decision: Registration Board aceeded to the request of the firm and approved products at serial no. 559 and 560 whereas product at serial no 558 was deferred for clarification whether the firm wants to withdraw their previously deferred application in view of the newly submitted applications or otherwise.
Dr Hafsa Karam Ellahi, DDC (PEC-I)
Routine Human Products
S/N Name and Brand Name Type of Form Remarks on the Decision address of (Proprietary name + Initial date, diary formulation (if manufacturer / Dosage Form + Fee including any) including Applicant Strength) differential fee International Composition Demanded Price status in stringent Pharmacological Group / Pack size drug regulatory Finished product agencies / Specification authorities Me-too status GMP status as depicted in latest inspection report (with date) by the Evaluator
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569. M/s Rocidex Form 5 Metadex by Deferred for Remington Ophthalmic Suspension. Dairy No. 2454 Macquin’s confirmation Pharmaceutical Each ml contains: dated 20-06- International of approval Industries Ciprofloxacin 2011 Pakistan status by (Pvt.) Ltd., Hydrochloride USP eq Rs:8,000/- reference drug 18KM Multan to Ciprofloxacin Rs./ 12000- Latest GMP authorities. Road, Lahore. base………3.0mg Photo copy of Inspection Dexamethasone differential fee 09-07-2015 USP..1.0mg challan is (Antibiotic & attached Corticosteroid) (Manfacturer’s specs) As per SRO 5ml, 10ml, 15ml
570. M/s Konac-M 75 Form 5 Cytopan 75 by Deferred for Remington Oral Tablets. Dairy No. 5857 Getz Karachi. the Pharmaceutical Each tablet contains: dated 29-06- confirmation Industries Diclofenac 2012 Latest GMP of (Pvt.) Ltd., Sodium.....75mg Rs:8,000/- Inspection description with 18KM Multan Misoprostol Rs./ 12000- 09-07-2015 reference to Road, Lahore. BP…..200mcg Photo copy of the use of (NSAID & differential fee API Prostaglandin E1 challan is misoprotol analogue) attached plain or with (Manfacturer’s specs) HPMC. As per SRO 2x10’s
571. M/s Valpin 5/320 Form 5 Valsan-AM 5/320 Approved Remington Oral Tablets. Dairy No. 2009 by Hilton Pharma Pharmaceutical Each film coated tablet dated 28-01- Industries contains: 2011 Exforge (Pvt.) Ltd., Amlodipine (as Rs:8,000/- Novartis (FDA) 18KM Multan besylate) BP……5.0mg Photo copy of Road, Lahore. Valsartan differential fee Latest GMP USP…320.0mg challan is Inspection (Calcium Channel attached 09-07-2015 Blocker & Angiotensin- As per SRO II Receptor Antagonist) 14’s, 28’s (Manfacturer’s specs)
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572. M/s Valpin 5/160 Form 5 Extor 5/160 by Approved. Remington Oral Tablets. Dairy No. 2012 Searle Pharma B&A Pharmaceutical Each film coated tablet dated 28-01- Division Industries contains: 2011 Exforge by M/s will confirm (Pvt.) Ltd., Amlodipine (as Rs:8,000/- Novartis receipt and Chairman 18KM Multan besylate) BP……5.0mg Dated.30-07- Pharmaceuticals RB will Road, Lahore. Valsartan 2013 UK. authorize USP…160.0mg Rs.12000/- issuance of (Calcium Channel Photo copy of Latest GMP letter. Blocker & Angiotensin- differential fee Inspection II Receptor Antagonist) challan is 09-07-2015 (Manfacturer’s specs) attached
As per SRO 14’s, 28’s
573. M/s Valpin 5/80 Form 5 Extor 5/80 by Approved Remington Oral Tablets. Dairy No. 2008 Searle Pharma Pharmaceutical Each film coated tablet dated 28-01- Industries contains: 2011 Exforge by M/s (Pvt.) Ltd., Amlodipine (as Rs:8,000/- Novartis 18KM Multan besylate) BP……5.0mg Dated.30-07- Pharmaceuticals Road, Lahore. Valsartan 2013 UK USP…80.0mg Rs.12000/- (Calcium Channel Photo copy of Latest GMP Blocker & Angiotensin- differential fee Inspection II Receptor Antagonist) challan is 09-07-2015 (Manfacturer’s specs) attached
As per SRO 14’s, 28’s
574. M/s Alufen Form 5 Acenac by S.J.& Approved Remington Oral Tablets. Dairy No. Not G Fazul Ellahie Pharmaceutical Each film coated tablet mentioned Industries contains: dated 30-06- Preservex by (Pvt.) Ltd., Aceclofenac 2011 Almirall Limited 18KM Multan B.P…100.0mg Rs:8,000/- UK Road, Lahore. (NSAID) 30-07-2013 (Manfacturer’s specs) Rs.12000/- Latest GMP Photo copy of Inspection differential fee 09-07-2015 challan is attached
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As per SRO 3x10’s
575. M/s Clariton 500mg Form 5 Klaricid by Approved Remington Oral Tablets. Dairy No. 5859 Abbott Pharmaceutical Each film coated tablet dated 29-06- Laboratories, Industries contains: 2012 Karachi. (Pvt.) Ltd., Clarithromycin Rs:8,000/- 18KM Multan USP…500mg 30-07-2013 Clarithromycin by Road, Lahore. (Antibiotic) Rs.12000/- Sandoz (FDA) (USP specs) Photo copy of differential fee challan is Latest GMP attached Inspection 09-07-2015 As per SRO 1x10’s 576. M/s Malfan 20/120 Form 5 Alar Dispersible Approved Remington Dispersible Dairy No. Not tablets by Searle Pharmaceutical Oral Tablets. mentioned Industries Each tablet contains: dated 30-06- Riamet (MHRA) (Pvt.) Ltd., Artemether……..20mg 2011 18KM Multan Lumefantrine…..120mg Rs:8,000/- Latest GMP Road, Lahore. (Anti Malarial) 30-07-2013 Inspection (Manfacturer’s specs) Rs.12000/- 09-07-2015 Photo copy of differential fee challan is attached As per SRO 2x8’s
577. M/s Orlight Form 5 Orlis Capsules by Approved Remington Oral Capsule. Dairy No. Not Ferozsons Pharmaceutical Each Capsule contains: mentioned Laboratories. Industries Orlistat…….120mg dated 30-06- (Pvt.) Ltd., (Anti-Obesity agent) 2011 Xenical by 18KM Multan (Manfacturer’s specs) Rs:8,000/- Hoffmann La Road, Lahore. 30-07-2013 Roche (FDA)
Rs.12000/- Latest GMP
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Photo copy of Inspection differential fee 09-07-2015 challan is attached
As per SRO 1x10’s
578. M/s Friends Bactirol Infusion Form 5 Avilox Infusion Approved Pharma (Pvt) Infusion Dairy No. 561 by Bayer Pvt Limited, 31- Each 250ml contains: dated 28-05- Limited KM, Ferozpure Moxifloxacin….400mg 2011 Canada. Road, Lahore. (Antibiotic) Rs:8,000/- Fee challan Avilox BP specs Rs.12000/- is not Bayer Pvt Limited available Pakistan As per SRO Not mentioned Last GMP inspection 16-02-2016 579. M/s Friends Cipfen Infusion Form 5 Ciprox Infusion Deferred for Pharma (Pvt) Infusion Dairy No. 522 by Phamedic (Pvt) the Limited, 31- Each 100ml contains: dated 28-05- Limited. clarification KM, Ferozpure Ciprofloxacin…..200mg 2011 of the Road, Lahore. (Antibiotic) Rs:8,000/- Cipro I.V Bayer formulation as lactate or Fee challan Pharmaceutical otherwise Rs.12000/- is not USA available As per SRO Last GMP Not mentioned inspection 16-02-2016
Replies of deferred Cases of previous meetings:-
S.# Name and Brand Name Type of Form Decision of Remarks on the Decision address of (Proprietary name Initial date, RB for formulation (if manufactur + Dosage Form + diary deferring the any) including er / Strength) Fee including Case. International Applicant Composition differential fee status in Pharmacological Demanded stringent drug Group Price / Pack regulatory Finished product size agencies / Specification authorities Me-too status
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GMP status as depicted in latest inspection report (with date) by the Evaluator
580. M/s Renal Cure Form 5 Case was RENAL PURE Deferred for Mission (Salt Concentrate 20-03-2015 Deferred in the Pharmaceut Solution) (MP/QA/022/ 254th meeting ROCK WELL clarification icals. Composition:Part 15 for comparison USA by the firm Plot No. A- A( liquid Form) Rs. 20,000/- of composition as on Form-5 in column of 94, S.I.T.E. Sodium As Per SRO with already Renacon strength of SUPER 139±15%mEq/L registered Medi Pak active HIGHWA Potassium For Single drug. Firm DML No. 809 ingredients Y 2.0±15%mEq/L Dialysis of 4 provided the firm has KARACHI Calcium hrs session comparison mentioned Pakistan. 2.5±15%mEq/L (4 litre A & which needs N/A. (Liquid Chloride 6.7 litres B) verification Dialysis 106±15%mEq/L price= from the solution Acetic acid Rs595/Dialysis Set concerned section: 4±15%mEq/L Packing section. DML No. Dextrose 200±15 Part A liquid Moreover, in 000809, mgm% 4,12 & 20 256th meeting dated 25- PART B (Liquid litre of DRB for all 02-2015) form) renal dialysate Sodium 59 Part B Liquid solution or mEq/L 6.7, 20 & 33 powder was Chloride 20 Litres decided to mEq/L seek opinion Bicarbonate 35-39 from experts: mEq/L Brig. (R) Prof. Dialysis salt Dr. Shaheen Mission , BP & Moin Bahria USP Specification Medical for finished College product. University and Head of Nephrology Department, Pakistan Institute of Medical Sciences,
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Islamabad. In this regard DFA letter has been submitted
581. M/s Renal Cure ( Form 5 Case was RENAL PURE Deferred for Mission Dialysate 20-03-2015 Deferred in the Pharmaceut Concentrate ( 254th meeting ROCK WELL clarification icals. Powder) MP/QA/023/1 for comparison USA by the firm Plot No. A- Composition:Part 5) of composition Renacon as on Form-5 in column of 94, S.I.T.E. A Rs. 20,000/- with already Medi Pak strength of SUPER Sodium As Per SRO registered DML No. 809 active HIGHWA 139±20%mEq/L drug. Firm ingredients Y Potassium For Single provided the firm has KARACHI 2.0±20%mEq/L dialysis , comparison mentioned Pakistan. Calcium 4 hrs session which needs N/A. (Liquid 2.5±20%mEq/L with Part A verification Dialysis Chloride (Equivalent to from the solution 106±20%mEq/L 4 L) concerned section: Acetic acid and part B section. DML No. 4±20%mEq/L (Equivalent to Moreover, in 000809, Dextrose 200±20 6.7 L)= 256th meeting dated 25- mgm% Price=595 of DRB for all 02-2015) Part B Rs/dialysis Set renal dialysate PART B (Powder Packs sizes solution or form) Cartilage & Part A powder was pouch 1040g, 3120 g decided to Bicarbonate 35-39 &24.626 kg seek opinion mEq/L pouches from experts: Dialysis salt Part B Brig. (R) Prof. Mission , BP & 597g,1790g & Dr. Shaheen USP Specification 8.42 kg in Moin Bahria for finished pouches. Medical product Part B College cartilage in University and 650g & 750 g Head of Nephrology Department, Pakistan Institute of Medical Sciences, Islamabad. In this regard
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DFA letter has been submitted 582. M/s Dilmazole Tablet Form-5 Deferred for The availability Deferred for Unipharma Each Tablet Dy. No: 1542 provision of in SRA;s is not the (Pvt) Ltd. contains: Rs.8000/- commitment confirmed confirmation 4.5km Metronidazole Dated. required by the Me-too: of approval Manga- BP….200mg 08-06-2011 firm (as Entamizole status by reference Raiwind Diloxanide Rs.12,000/- approved in Tablets of adrug Road Furoate Dated. 251 st meeting) Abbott authorities. Lahore. BP….250mg 29-07-2013 Proposed shelf Laboratories Rs.65/30’s life of the drug (Pvt.) Ltd. (Amoebicide) is 3 years in BP Specs the dossier (max. 2 yrs. As approved in 251 st meeting of RB). Detail of coating material is not provided. Specs on label are not mentioned. In 255th meeting of RB 583. M/s Dilmazole Form-5 Deferred for The availability Deferred for Unipharma Suspension Dy. No: 1546 provision of in SRA;s is not the (Pvt) Ltd. Each 5ml contains: Rs.8000/- commitment confirmed confirmation 4.5km Metronidazole Dated. required by the Me-too: of approval Manga- BP…….200mg 08-06-2011 firm (as Entamizole status by reference Raiwind Diloxanide Rs.12,000/- approved in suspension of drug Road Furoate Dated. 251st meeting) Abbott authorities. Lahore. BP…250mg 29-07-2013 Specs on label Laboratories are not (Pvt.) Ltd. (Amoebicide) Rs.60/60 ml mentioned. In BP Specs 255th meeting of RB 584. M/s Klarixin Tablet Form-5 Deferred for Biaxin tab. Approved. Unipharma Each tablet Dy. No: 1499 provision of Clarithromycin (Pvt) Ltd. contains. Rs.8000/- commitment 250mg 4.5km Clarithromycin…2 Dated. 08-06- required by the of Abbvie Manga- 50mg 2011 firm (as USFDA Raiwind (Antibiotic) Rs.12,000/- approved in Me-too: Claryan Road Specs: USP Dated: 29-07- 251st meeting) tab. 250mg Lahore. 2013 Proposed shelf Roryan pharma Rs.240/10’s life is 3 years Pakistan (Pvt)
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Methylene Ltd. chloride used in coating material may be replaced with some suitable solvent. In 255th meeting of RB
585. M/s Rostein 150mg Form-5 Deferred for ERDOTIN Deferred for Unipharma Capsule. Dy. No: 1519 provision of capsule the (Pvt) Ltd. Each capsule Rs.8000/ commitment Edmond confirmation 4.5km contains: dated 08-06- required by the Pharma Srl of approval Manga- Erdosteine…150m 2011 firm (as Milano, Italy status in reference Raiwind g Rs.12,000/- approved in Me-too: Dostin adrug Road (Mucolytic or Dated 29-07- 251 st meeting) of Brookes authorities Lahore. expectorant) 13 Some of the Pharmaceutical Unipharma Specs Rs.160/- 20’s documents in Laboratories the Dossier are (Pak.) Ltd. not signed by QC and production manager. In 255th meeting of RB 586. M/s Unifen-T Tablet Form-5 Deferred for IBU-TAB Approved Unipharma Each Tablet Dy. No: 1537 provision of Ibuprofen (Pvt) Ltd. contains: Rs.8000/- commitment 400mg, of 4.5km Ibuprofen Dated. 08-06- required by the ALRA USFDA Manga- (BP)……400mg 11 firm (as Me-too: Raiwind (Propionic acid) Rs.12,000/- approved in Brufen Tablet Road Specs. Unipharma Dated.29-07-13 251 st meeting) of Abbott Lahore. Pharmacologic (Pvt)Ltd. Rs.450- al group is not 25x10’s correct. Detail of coating material is not provided. Documents in the Dossier are not signed by QC and production manager. In 255th meeting of RB Minutes for 257th Registration Board Meeting 218
587. M/s Unisolin Capsule. Form-5 Deferred for Flomax capsule Deferred for Unipharma Capsule Dy. No: 1551 provision of Tamsulosin Hcl the (Pvt) Ltd. Each capsule Rs.8000/- commitment 0.4mg of submission 4.5km contains: dated 08-06- required by the Boehringer of source of Manga- Tamsulosin Hcl 2011 firm (as Ingelheim pellets in case Raiwind eq. to 0.4mg Rs.12,000/ approved in USFDA imported Road Tamsulosin Dated 29-07-13 251 st meeting) Uroflo Capsule pellets with Lahore. (Selective a-1 Rs.600/- 1x10’s For inactive Tamsulosin legalized Blocker) ingredients it Hydrochloride: GMP, Unipharma specs. is mentioned 0.4mg stability data that "Inactive NOVARTIS and will be PHARMA differential adjusted at the (PAK) LTD fee. time of formulation" In 255th meeting of RB 588. Unipride Tablet Form-5 Dy. Deferred for roduct literature Deferred as Each Tablet No: 1532 provision of of Ganaton 50 the contains: Itopride Rs.8000/- commitment mg (Abbott, formulation HCl ……..50mg Dated: 08-06- required by the Japan) shows is under (Antispasmodic 2011 firm (as that the drug is review. and Rs.12,000/- approved in available in gastroprokineti Dated: 31-07- 251 st meeting) Japan since c) 2013 Proposed shelf 1983. However, (unipharma Rs.150/1x10’s life of the drug same cannot specs) is 3 years in beverified from the dossier PDMA as (max. 2 yrs. As official website approved in provides 251 st meeting information of RB) Detail from 2004- of coating 2014Japan Me- material is not too: Ganaton provided. Itopride HCl Documents in 50mg of Abbott the Dossier are Laboratories not signed by (Pakistan) QC and Limited. Last production GMP manager. inspection was (Deferred for conducted on confirmation 23-01-2015 of availability of formulation in PDMA
Minutes for 257th Registration Board Meeting 219
Japan in 250th meeting of RB). 255th meeting of RB.
589. M/s Flunifen Form-5 Deferred for Ansaid of Approved. Unipharma Tablet Dy. No: 1539 provision of Pharmacia and (Pvt) Ltd. Each Tablet Rs.8000/- commitment Up john 4.5km contains: Dated. 08-06- required by the USFDA Manga- Flurbiprofen.100m 2011 firm (as Me-too: Ansaid Raiwind g Rs.12,000/- approved in Pfizer Lab. Ltd. Road (Propionic acid) Dated.29-07-13 251 st meeting) Lahore. Specs: BP Rs.186/- 3x10’s Pharmacologic al group is not clear Detail of coating materials not provided Documents in the Dossier are not signed by QC and production manager. In 255th meeting of RB 590. M/s Unilokast 5mg Form-5 Deferred for Montelucast Approved Unipharma Tablet Dy. No: 1516 provision of 5mg chewable with change (Pvt) Ltd. Each chewable Rs.8000/- commitment tablets of of name. 4.5km tablet contains. Dated. required by the Actavis Manga- Montelokas (as 08-06-2011 firm (as Barnstaple UK Raiwind montelokas Rs.12,000/- approved in Me-too: Road sodium) ….…5mg Dated. 251 st meeting) Aerokast 5mg Lahore. (Leukotrine 29-07-2013 Proposed shelf Barret Hodgson inhibitor (Anti Rs.600/20’s life of the drug Pakistan (Pvt) asthmatic) is 3 years in Ltd. Unipharma Specs the dossier (max. 2 yrs. As approved in 251 st meeting of RB). In 255th meeting Minutes for 257th Registration Board Meeting 220
of RB
591. M/s Uniterole Tablet Form-5 Deferred for Detrusitol 2 mg Approved. Unipharma Each Tablet Dy. No: 1522 provision of film coated (Pvt) Ltd. contains: Rs.8000/- commitment tablets 4.5km Tolterodine B.P Dated. 08-06- required by the Each film Manga- ……..2mg 2011 firm (as coated tablet Raiwind Rs.12,000/- approved in contains Road (Anticholinergic Dated.31-07- 251 st meeting) tolterodine Lahore. group) 2013 Detail of tartrate 2 mg Unipharma Specs coating corresponding Rs.714.20/2x1 material is not to 1.37mg 0’s provided. tolterodine of Documents in Pfizer Ltd UK the Dossier are Me-too: not signed by Detrusitol of QC and Pfizer production manager. Qualitative and quantitative composition is not given. In 255th meeting of RB 592. M/s Klarixin-D Tablets Form-5 Deferred for Biaxin tab. Approved. Unipharma (500mg) Dy. No: 1501 provision of Clarithromycin (Pvt) Ltd. Tablet Rs.8000/- commitment 500mg of 4.5km Each Tablet Dated. 08-06- required by the Abbvie Manga- contains: 2011 firm (as USFDA Raiwind Clarithromycin Rs.12,000/- approved in Me-too: Road USP……500mg Dated. 29-07- 251 st meeting) Claryan tab. Lahore. (Antibiotic) 13 Proposed shelf 500mg Specs: USP life is Roryan pharma Rs.445/- 1x10’s mentioned in Pakistan the dossier 3 (Pvt)Ltd. years Methylene chloride used Minutes for 257th Registration Board Meeting 221
in coating material may be replaced with other suitable solvent. In 255th meeting of RB
593. M/s Ursochole Capsule Form-5 Approved. Unipharma 250mg. Dy. No: 1554 (Pvt) Ltd. Capsule Deferred for Ursofalk 4.5km Each capsule Rs.8000/- provision of 250mg Hard Manga- contains: dated 08-06- commitment Capsules of Dr. Falk Pharma Raiwind Ursodexycholic 2011 required by Road Acid….250mg Rs.12,000/ UK Ltd Lahore. (Bile Acid) Dated 29-07-13 the firm (as Me-too: Triptor Unipharma specs. approved in CCL (Pvt.) Ltd. Rs.250/- 1x10’s 251 st meeting) Proposed shelf life is given 3 years Composition (active & excipient) of the product is not given Documents are not signed by QC and Production in charge. In 255th meeting of RB
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594. M/s Ciprovid 500mg Form-5 Deferred for Cipro of Bayer Approved. Unipharma Tablet Dy. No: 1492 provision of Hlthcare (Pvt) Ltd. Each Tablet Rs.8000/- commitment ciprofloxacin 4.5km contains: dated 08-06- required by the HCl EQ to 500 Manga- Ciprofloxacin (as 2011 firm (as mg base Raiwind ciprofloxacin HCl) Rs.12,000/- approved in USFDA Road BP……..500mg Dated 29-07- 251 st meeting) Me-too: Lahore. (1.164mg of 13 Proposed shelf Ciproxin ciprofloxacin HCl Rs.400/- 1x10’s life is given 3 500mg tablet of is EQ to1mg years. In 255th Bayer Pakistan ciprofloxacin ) meeting of RB (Pvt) Ltd. (Antibiotic (Quinolone carboxylic acid)) Specs BP 2007 595. M/s Irontose-F Form-5 Deferred for Ferosoft FA by Approved. Unipharma Tablet Dy. No: 1515 the Hilton Pharma (Pvt) Ltd. Each chewable Rs.8000/- submission of Japan 4.5km tablet contains. Dated. Commitment Manga- Iron-III Hydoxide 08-06-2011 as per decision Maltofer by Raiwind Polymaltose Rs.12,000/- of the board in Getz Pharma Road Complex Dated. 256th meeting Lahore. equivalent to 31-07-2013 of RB Priority elemental Rs.300/20’s No. 1126 iron………….100 mg Folic acid……0.35mg (Heamatonic) (Manufacturer Specs) 596. M/s Utrahit-beta Form-5 Deferred for Vrexidol by Approved. Unipharma Tablet Dy. No: 1515 the Trinity Pharma (Pvt) Ltd. Each tablet Rs.8000/- submission of UK 4.5km contains. Dated. Commitment Manga- Piroxicam-beta- 08-06-2011 as per decision Pirodex by Raiwind cyclodextrin 191.2 Rs.12,000/- of the board in Schazoo Zaka Road eq. to Dated. 256th meeting Lahore. Piroxicam……20 31-07-2013 of RB Priority mg Rs.170/1x10’s No. 1108 (Anti- Inflammatory Analgesic) (Manufacturer’s Specs)
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597. M/s Uviarein Form-5 Deferred for Artrodar by Deferred as Unipharma Tablet Dy. No: 1525 the Proter Pharma the (Pvt) Ltd. Each tablet Rs.8000/- submission of Itlay formulation 4.5km contains. Dated. Commitment (need to be is under Manga- Diacerein…….50 08-06-2011 as per decision verified) review / expert Raiwind mg Rs.12,000/- of the board in Diacerein by opinion Road Dated. 256th meeting Genome Lahore. (Manufacturer’s 31-07-2013 of RB Pharma Priority Specs) Rs.270/1x10’s (need to be No. 1113 verified) 598. M/s Unifen-100 Form-5 Deferred for Brufen Approved. Unipharma Suspension Dy. No: 1517 the Suspension by (Pvt) Ltd. Each 5ml contains: Rs.8000/- submission of Abbott UK 4.5km Ibuprofen Dated. Commitment (need to be Manga- BP……100mg 08-06-2011 as per decision verified) Raiwind (Propionic acid) Rs.12,000/- of the board in Brufen Road (B.P Specs) Dated. 256th meeting Suspension Lahore. 31-07-2013 of RB Abbot Pharma Priority Rs.60/120 ml (need to be No. 1118 verified) 599. M/s Fidohit-S Form-5 Deferred for Pepcid by Deferred for Unipharma Suspension Dy. No: 1543 the Morsan Uk the (Pvt) Ltd. Each 5ml contains: Rs.8000/- submission of (need to be submission 4.5km Famotidine……… Dated. Commitment verified) of Manga- .10mg/5ml 08-06-2011 as per decision G-met by application with new fee Raiwind (H2 Blocker) Rs.12,000/- of the board in Tabros Pharma th as per the Road (Manufacturer’s Dated. 256 meeting (need to be decision of Lahore. Specs) 31-07-2013 of RB verified) 250th Priority Rs.45/60 ml meeting of No. 1109 the board.
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600. M/s Cetrihit-S Form-5 Deferred for Zyrtec Syrup Approved. Unipharma Syrup Dy. No: 1555 the by UCH (Pvt) Ltd. Each 5ml contains: Rs.8000/- submission of Belgium 4.5km Cetirizine Dated. Commitment (need to be Manga- USP…….5mg/5ml 08-06-2011 as per decision verified) Raiwind (Antihistamine:Ox Rs.12,000/- of the board in Alce by Road yzine Type) Dated. 256th meeting Dermatechno Lahore. (B.P Specs) 31-07-2013 of RB Priority Rs.80/120 ml (need to be No. 1124 verified) 601. M/s Irontose Form-5 Deferred for Ferrum Syrup Approved Unipharma Syrup Dy. No: 1514 the by Sigma with change (Pvt) Ltd. Each 5ml contains: Rs.8000/- submission of Australia of name. 4.5km Iron-III Hydroxide Dated. Commitment (need to be Manga- Polymaltose 08-06-2011 as per decision verified)) Raiwind complex eq. to Rs.12,000/- of the board in Ferosoft by Road elemental iron… Dated. 256th meeting Hilton Lahore. ….50mg 31-07-2013 of RB (need to be Priority (Heamatinic) Rs.120+/120 verified) No. 1125 (Manufacturer’s ml Specs) 602. M/s Torvia 20mg Form-5 Deferred for: Lipitor Approved. Pakistan Tablet Dy. No: 266 incomplete ( Atorvastatin Pharmaceut Each film coated Rs.8000/- documents Calcium) ical tablet contains: Dated. confirmation EQ 20MG Products Atorvastatin….20 26-10-2010 of fee deposit Base of Pfizer (Pvt) Ltd. mg (original cash from B&A USFDA D-122, (Lipid-lowering deposit slip) Division in Sindh agent) Rs.12,000/- 255th meeting Atorva-20 Industrial Dated. of RB (Atorvastatin Trading PPP'S Specs 26-07-2013 20mg as Estate, (photo copy of Calcium Karachi. cash deposit Trihydrate of slip) Pharmatec Rs.40/Tablet 10’s Last GMP inspection was conducted on 19-12-2014 603. M/s Torvia 10mg Form-5 Deferred for: Lipitor Approved. Pakistan Tablet Dy. No: 265 incomplete ( Atorvastatin Pharmaceut Each film coated Rs.8000/- documents Calcium) ical tablet contains: Dated. confirmation EQ 10MG Products Atorvastatin…10m 26-10-2010 of fee deposit Base of Pfizer (Pvt) Ltd. g (original cash from B&A USFDA D-122, (Lipid-lowering deposit slip) Division in Atorva-10
Minutes for 257th Registration Board Meeting 225
Sindh agent) Rs.12,000/- 255th meeting (Atorvastatin Industrial Dated. of RB 10mg as Trading PPP'S Specs 26-07-2013 Calcium Estate, (photo copy of Trihydrate of Karachi. cash deposit Pharmatec slip)
Rs.20/Tablet 10’s Last GMP inspection was conducted on 19-12-2014 604. M/s Glimicron 80mg Form-5 Deferred for: Gliclazide Approved. Pakistan Tablet Dy. No: 267 incomplete 80mg Tablets Pharmaceut Each tablet Rs.8000/- documents Wockhardt UK ical contains: Dated. confirmation Ltd. Products Gliclazide……80 29-10-2010 of fee deposit (Pvt) Ltd. mg (original cash from B&A Diamicron D-122, (Antidiabetic) deposit slip) Division in 80mg Tablets Sindh Rs.12,000/- 255th meeting SERVIER Industrial BP Specs Dated. of RB RESEARCH & Trading 26-07-2013 PHARMACEU Estate, (copy of cash TICALS Karachi. deposit slip) PAKISTAN (PVT) LTD. Rs.8/Tablet Not Mentioned. Last GMP inspection was conducted on 19-12-2014
605. M/s Mega COLOPAN Form-5 Deferred for No-Spa of Approved. Pharmaceut Tablets Dy.No: confirmation Sanofi icals Tablets 10555, of Karachi Limited Each film coated dated: 12-11- availability in Product is 27-km tablet contains: 10 reference available in the Raiwind Drotaverine as 8000/- dated: SRA’s. following Road, hydrochloride..40 12-11-10 2. Final notice countries of the Lahore. mg 12,000/- dated for EU Hungary, Antispasmodic & 05-08-13 rectification of Bulgaria and Anticholinergic As per SRO/ shortcomings/ Polland Manufacturer’s Pack of 20’s observations. Specs In 247th meeting of RB
Minutes for 257th Registration Board Meeting 226
606. M/s Mega Colopan 80mg Form-5 Dy. Deferred for No-Spa of Approved. Pharmaceut Tablet Tablet Each No: 10547 rectification of Sanofi icals tablet contains: dated. 12-11- shortcomings Karachi. Limited Drotaverine…..80 2010 as per decision Product is 27-km mg add as Rs.8000/- of earlier available in the Raiwind drotaverine (Copy) Fee Registration following Road, hydrochloride Challan of Board meeting countries of the Lahore. (Antispasmodics Rs.12,000/- in 255th EU Hungary, & not attached. meeting Bulgaria and Anticholinergics) As per SRO Polland 60ml. Manufacturer’s Specs 607. M/s Mega ETOPRIDE OD Form-5 Deferred for Evidence of Rejected as Pharmaceut Tablets 150mg Dy.No: 10540 review of availability in the icals Each sustained dated: 12-11- formulation by SRA’s is not formulation Limited release tablet 10 the submitted by is not 27-km contains: 8000/- dated: review the approved by reference Raiwind Itopride 12-11-10 committee. firm. th drug Road, hydrochloride….1 12,000/- dated In 247 Under evidence regulatory Lahore. 50 05-08-13 meeting of RB of agencies mg As per SRO/ local Antiemetic & Pack of 10’s availability Gastroprokinetic reference of Manufacturer Ganaton & Ipride 50 mg tablet of Abbot & Wilshire is provided. Molecule is already under review. 608. M/s Mega ETOPRIDE Form-5 Deferred for Not available in Deferred as Pharmaceut Tablets Dy.No: Not review of SRA’s the icals 50mg provided, formulation by Ganaton of formulation Limited Each tablet dated: 12-11- review Abbott Labs is under 27-km contains: 10 committee in Karachi review. Raiwind Itopride 8000/- dated: 247th meeting Road, Hydrochloride….. 12-11-10 of RB Lahore. 50 12,000/- dated 0mg 05-08-13 Gastroprokinetic As per SRO/ & Pack of 10’s Antiemetic Manufacturer
Minutes for 257th Registration Board Meeting 227
609. M/s Mega MEGAGESIC Form-5 1. Deferred for Norgesic by Approved. Pharmaceut Tablets Dy.No: Not rectification of M/s Inova icals Each tablet provided, shortcomings/ Pharmaceutical Limited contains: dated: 12-11- observations in s Australia 27-km Paracetamol…450 10 preceding Raiwind mg 8000/- dated: column. Flexar Tablet of Road, Orphenadrine 12-11-10 2. Final notice Candid Pharma Lahore. citrate….35mg 12,000/- dated for Pasrur Analgesic & 05-08-13 rectification of skeletal As per SRO/ shortcomings/ muscle relaxant Pack of 100’s observations. In 247th meeting of RB
Minutes for 257th Registration Board Meeting 228
Stability data submitted by various firms Evaluator: Muhammad Amin, DDC (PEC-II) M/s Shrooq Pharma, Lahore. Registration Board in its 255th meeting discussed the stability data submitted by M/s Shrooq Pharma , Lahore in respect of registration of Sofobuvir tablets and decided as follows: Drug Sofvir tablets (Sofosbuvir) 400 mg Source Virupaksha Organics Limited India. Storage Condition Real Time: 30 C and 75% RH Accelerated: 40 C and 75% RH Time Period Real Time: 12 months Accelerated: 6 months Frequency 0, 3, 6, 9, 12 months
Batch Size 400, tablets per batch. No. of Batches 03 Sample Size 30 tablets Meeting Deferred in 244th and 251st & 253rd meeting of Registration Board for stability studies. Dissolution test was not submitted by the firm in the data submitted earlier and presented in 253rd meeting of Registration Board. The case was deferred as the data was not in accordance with requirements of the Board. The firm included dissolution test and submitted the revised data in 255th meeting.
ACCELERATED STABILITY REPORT
PRODUCT SOFVIR TABLET BATCH NO. 001 GENERIC NAME SOFOSBUVIR STRENGTH 400 mg DOSAGE FORM TABLET MFG.DATE 08-2014
Minutes for 257th Registration Board Meeting 229
DATE OF STORAGE 04-08-2014 EXPIRY DATE 07-2016 STORAGE CONDITION 40°C ± 2 / 75 % RH ±5
BATCH SIZE 400 TABLETS
PACK SIZE 28 Tablets per pack SAMPLE SIZE 30 TABLETS TESTING PERIOD (MONTHS) S.N TEST SPECIFICATIONS INITIA O 01 02 03 04 05 06 L White color oblong, film Complies Complies Complies Complies Complies Complies Complies coated tablet with SHROOQ 1. Description engraved on one side and plain on other side. 2. Identification Sofosbuvir must be positive +ve +ve +ve +ve +ve +ve +ve 3. Average weight of tablet 685 mg±5.0 % 687 686 686 687 685 686 685 4. Disintegration Not more than 30 minutes 6 6 6 7 6 6 6 5. Dissolution NLT 80 % in 30minutes 93.3 % 92.2 % 91.5 % 91.8 % 90.3 % 89.3 % 88.5 % Assay : 90-110% 6. Each Tablet Contains 99.8% 99.7% 99.6% 99.6% 99.5% 99.5% 99.5% (as label) Sofosbuvir 400 mg 04.08.1 02.09.1 04.10.1 05.11.1 05.12.1 05.01. 7. Test Date As per SOP 09.02.15 4 4 4 4 4 15 Analyst (signature) Abid Abid Abid Abid Abid Abid Abid
REMARKS: PRODUCT IS STABLE AT RECOMMENDED STORAGE CONDITIONS UP TO DATE.
Minutes for 257th Registration Board Meeting 230
ACCELERATED STABILITY REPORT
SOFVIR TABLET 002 PRODUCT BATCH NO. GENERIC NAME SOFOSBUVIR STRENGTH 400 mg DOSAGE FORM TABLET MFG.DATE 08-2014 DATE OF STORAGE 06-08-2014 EXPIRY DATE 07-2016 STORAGE CONDITION 40°C ± 2 / 75 % RH ±5
BATCH SIZE 400 TABLETS PACK SIZE 28 Tablets per pack
SAMPLE SIZE 30 TABLETS
TESTING PERIOD (MONTHS) S.N TEST SPECIFICATIONS INITIA O 01 02 03 04 05 06 L White color oblong, film Complies Complies Complies Complies Complies Complies Complies coated tablet with SHROOQ 1. Description engraved on one side and plain on other side. 2. Identification Sofosbuvir must be positive +ve +ve +ve +ve +ve +ve +ve 3. Average weight of tablet 685 mg±5.0 % 687 686 686 687 685 685 685 4. Disintegration Not more than 30 minutes 6 6 6 7 6 6 6 5. Dissolution NLT 80 % in 30minutes 93.5 % 94.0 % 93.2 % 92.7 % 91.4 % 90.2 % 89.6 % Assay : Each Tablet Contains 90-110% 6. 99.9% 99.8% 99.6% 99.6% 99.5% 99.4% 99.5% Sofosbuvir (as label) 400 mg 06.08.1 02.09.1 04.10.1 05.11.1 05.12.1 05.01. 7. Test Date As per SOP 09.02.15 4 4 4 4 4 15
Minutes for 257th Registration Board Meeting 231
Analyst (signature) Abid Abid Abid Abid Abid Abid Abid
REMARKS: PRODUCT IS STABLE AT RECOMMENDED STORAGE CONDITIONS UP TO DATE.
ACCELERATED STABILITY REPORT
PRODUCT SOFVIR TABLET BATCH NO. 003
GENERIC NAME SOFOSBUVIR STRENGTH 400 mg DOSAGE FORM TABLET MFG.DATE 08-2014 DATE OF STORAGE 08-08-2014 EXPIRY DATE 07-2016 STORAGE CONDITION 40°C ± 2 / 75 % RH ±5
BATCH SIZE 400 TABLETS PACK SIZE 28 Tablets per pack
SAMPLE SIZE 30 TABLETS
TESTING PERIOD (MONTHS) S.N TEST SPECIFICATIONS INITIA O 01 02 03 04 05 06 L Complies Complies Complies Complies Complies Complies White color oblong, film Complies coated tablet with SHROOQ 1. Description engraved on one side and plain on other side. 2. Identification Sofosbuvir must be positive +ve +ve +ve +ve +ve +ve +ve 3. Average weight of tablet 685 mg±5.0 % 687 686 686 687 685 684 684 4. Disintegration Not more than 30 minutes 6 6 6 7 6 6 6 5. Dissolution NLT 80 % in 30minutes 92.4 % 91.6 % 92.8 % 92.0 % 91.4 % 89.5 % 89.8 % Assay : 90-110% 6. 99.9% 99.8% 99.6% 99.7% 99.6% 99.5% 99.4% Each Tablet Contains (as label)
Minutes for 257th Registration Board Meeting 232
Sofosbuvir 400 mg 08.08.1 02.09.1 04.10.1 05.11.1 05.12.1 05.01. 7. Test Date As per SOP 09.02.15 4 4 4 4 4 15 Analyst (signature) Abid Abid Abid Abid Abid Abid Abid
REMARKS: PRODUCT IS STABLE AT RECOMMENDED STORAGE CONDITIONS UP TO DATE.
PRODUCT STABILITY TESTING REPORT (REAL TIME)
Product Sofvir Tablet Batch No. 001 Strength 400 mg Manufacturing Date 08-2014 Generic Name Sofosbuvir Expiry Date 07-2016 Dosage Form Tablet Batch Size 400 Tablets Pack Size 28 Tablets per Pack Sample Size 30 Tablets Storage Condition 30°C ± 2, RH 65 % ± 5 Date of Storage 04-08-2014
Minutes for 257th Registration Board Meeting 233
TESTING PERIOD (MONTHS) S.NO TEST SPECIFICATIONS INITIAL 03 06 09 12 18 24 White, oblong film coated tablet with Physical 1 shrooq embossed on one Complies Complies Complies Complies Complies Appearance side & plain on other side. Sofosbuvir must be 2 Identification Confirmed Confirmed Confirmed Confirmed Confirmed positive Disintegration 3 NMT 30 minutes 6 minutes 6 minutes 6 minutes 5 minutes 5 minutes Time Dissolution NLT 80 % in 30 4 93.3 % 91.6 % 92.3 % 91.6 % 91.2 % Test minutes 5 Assay 90 % to 110 % 99.8 % 99.4 % 99.1 % 98.6 % 98.0 % 04-08- 06-11- 10-02- 12-05- 11-08- Date --- 2014 2014 2015 2015 2015 Analyst --- Abid Abid Abid Abid Abid
REMARKS: The stability study is continued.
PRODUCT STABILITY TESTING REPORT (REAL TIME)
Product Sofvir Tablet Batch No. 002 Strength 400 mg Manufacturing Date 08-2014 Generic Name Sofosbuvir Expiry Date 07-2016
Minutes for 257th Registration Board Meeting 234
Dosage Form Tablet Batch Size 400 Tablets Pack Size 28 Tablets per Pack Sample Size 30 Tablets Storage Condition 30°C ± 2, RH 65 % ± 5 Date of Storage 06-08-2014
TESTING PERIOD (MONTHS) S.NO TEST SPECIFICATIONS INITIAL 03 06 09 12 18 24 White, oblong film coated Physical tablet with shrooq embossed 1 Complies Complies Complies Complies Complies Appearance on one side & plain on other side. 2 Identification Sofosbuvir must be positive Confirmed Confirmed Confirmed Confirmed Confirmed Disintegration 3 NMT 30 minutes 6 minutes 6 minutes 6 minutes 5 minutes 5 minutes Time 4 Dissolution Test NLT 80 % in 30 minutes 93.5 % 94.2 % 94.6 % 90.7 % 92.5 %
5 Assay 90 % to 110 % 99.9 % 99.6 % 99.3 % 98.8 % 98.3 % 06-08- 06-11- 10-02- 12-05- 11-08- Date --- 2014 2014 2015 2015 2015 Analyst --- Abid Abid Abid Abid Abid
REMARKS: The stability study is continued.
Minutes for 257th Registration Board Meeting 235
PRODUCT STABILITY TESTING REPORT (REAL TIME)
Product Sofvir Tablet Batch No. 003 Strength 400 mg Manufacturing Date 08-2014 Generic Name Sofosbuvir Expiry Date 07-2016 Dosage Form Tablet Batch Size 400 Tablets Pack Size 28 Tablets per Pack Sample Size 30 Tablets Storage Condition 30°C ± 2, RH 65 % ± 5 Date of Storage 08-08-2014
TESTING PERIOD (MONTHS) S.NO TEST SPECIFICATIONS INITIAL 03 06 09 12 18 24 White, oblong film coated Physical tablet with shrooq embossed 1 Complies Complies Complies Complies Complies Appearance on one side & plain on other side. 2 Identification Sofosbuvir must be positive Confirmed Confirmed Confirmed Confirmed Confirmed Disintegration 3 NMT 30 minutes 6 minutes 6 minutes 6 minutes 6 minutes 5 minutes Time 4 Dissolution Test NLT 80 % in 30 minutes 92.4 % 92.8 % 91.4 % 91.0 % 91.1 %
5 Assay 90 % to 110 % 99.9 % 99.5 % 99.2 % 98.9 % 98.2 % 08-08- 06-11- 10-02- 12-05- 11-08- Date --- 2014 2014 2015 2015 2015 Analyst --- Abid Abid Abid Abid Abid
Minutes for 257th Registration Board Meeting 236
REMARKS: The stability study is continued.
Documents / Data provided by the applicants (M/s Sharooq Pharma, Lahore)
Sr. No. Documents to be provided Status
1. COA of API Yes 2. Approval of API by regulatory authority of country of Yes (Photocopy origin or GMP certificate of API manufacturer issued by provided) regulatory authority of country of origin. 3. Protocols followed for conduction of stability study and Yes details of tests. 4. Data of 03 batches will be supported by attested Yes respective documents like chromatograms, laboratory reports, data sheets etc. 5. Documents confirming import of API etc. Yes (By Courier) 6. All provided documents will be attested (name, sign and Yes stamp) for ensuring authenticity of data / documents. 7. Commitment to continue real time stability study till Yes assigned shelf life of the product.
Decision: Board observed that the firm has submitted revised data by including dissolution studies in the stability data. This parameter was not included in the data submitted by the firm earlier and case was also deferred in 253rd meeting. Therefore, the Board decided to defer the case for clarification from the firm regarding the revised data with inclusion of dissolution studies.
The firm has now submitted following clarification: “we would like to bring into your kind knowledge that initially we did not have a developed dissolution test method for sofvir tablets; but afterwards but once developed by our concerned technical personnel we’ve been performing dissolution tests for the product aforementioned (i.e. Sofvir Tablet 400mg) throughout conductance of its stability studies. All raw data regarding
Minutes for 257th Registration Board Meeting 237
conductance of dissolution tests during whole stability study period is available with us: But unfortunately, dissolution test data couldn’t be included in stability study reports submitied for registration of Sofvir Tablet 400mg. However, after being pointed out during 253rd meeting of DRB held on 5th and 6th October, 2015, We’ve already submitted stability studies with inclusion of dissolution data vide letter No. IPI/DRAP/10-15 dated 20.10.2015 (Copy attached for ready reference).
Decision: Board discussed the case in detail and decided to provide oppurtunity of personal hearing to the firm to explain their position before the Board.
Minutes for 257th Registration Board Meeting 238
Cirin Pharma, Hattar
Drug Sofvir tablets (Sofosbuvir) 400 mg Source Virupaksha Organics Limited India. Storage Condition Real Time: 30 C and 75% RH Accelerated: 40 C and 75% RH Time Period Real Time: 6 months Accelerated: 6 months Frequency 0, 3, 6 months
Batch Size 250, tablets per batch. No. of Batches 03 Sample Size 30 tablets Meeting Deferred in 251st meeting of Registration Board.
STABILITY STUDY DATA SHEET
1.0 Product details:
Product name Generic Sovir 400mg tablets (Sofosbuvir) Batch No. P1 name/Dosage form
Description of pack Batch Size. 250 tablets (container closure system) 400mg film coated, yellow oblong tablet in HDPE bottle and CRC cap.
Parameters and tests mentioned As per Product Specifications Mfg. Date 06-2015
Recommended storage conditions Short term conditions (Accelerated) 40 ºC + 2ºC, 75% ±5%RH Ex Date 06-2017 Long term conditions (Real time)30 ºC + 2ºC, 65% ±5% RH '
Minutes for 257th Registration Board Meeting 239
Date of initiation & implementation 24-06-2015 (API) lot no. AS0FC0415009
Stability No. STB-P01
Sample taken for physical tests = 30 Tab Sample taken for Chemical tests = 120 Tab Approval by: QC Manager Sample taken for Microbiological tests = NA QA Manager Extra samples (if needed) = 35 Tab Production Manager: Total Sample size (approx) = 185 Tab R&D Manager:
Assessment frequency (weeks) Initial I 2 3 4 6 8 12 16 20 24 26
Date of Testing 24-06-15 24-09-15 24-12-15
Mode of testing(F = Full. P= Partial testing) F F F
Tests (Physical. Storage Acceptance Chemical, conditions Criteria Microbiological)
Yellow Oblong
shaped film
Description coated tablets, one 30°C + 2°C & Complies side CIRIN Complies Complies 65%RH engraved ,other + 5% RH side plane
Disintegration Time NMT 30min 30°C + 2°C & 65%RH 3min 3min 3min + 5% RH
Minutes for 257th Registration Board Meeting 240
694.96mg ° ° Average Weight 695mg/tab + 5% 30 C + 2 C & 65%RH 692.87mg 694.86mg + 5% RH
Complies 30°C + 2°C & 65%RH Complies Complies Identification Must Comply + 5% RH
Assay (90-110% of L.C) 30°C + 2°C & 100.9% 65%RH 99.88% 98.52% + 5% RH
(90.06— NLT 70% of ° ° (90.59--- (90.59--- 30 C + 2 C & 65%RH 95.03%) Dissolution labeled amount + 5% RH 92.50%) 96.62%) in 30min
Analyst signature (after completion of every time line) Conclusion by QA (after completion of the study )
Assessment frequency (weeks) Initial I 2 3 4 6 8 12 16 20 24 26
Date of Testing 24-06-15 24-09-15 24-12-15
Mode of testing(F = Full. P= Partial testing) F F F
Tests (Physical. Storage Acceptance Chemical, conditions Criteria Microbiological) (Accelerated)
Minutes for 257th Registration Board Meeting 241
Yellow Oblong
shaped film Description coated tablets, Complies ° ° one side CIRIN 40 C + 2 C & 75%RH Complies Complies engraved ,other + 5% RH side plane
3min Disintegration NMT 30min 40°C + 2°C & 75%RH Time 3min 3min + 5% RH
694.96mg 695mg/tab + ° ° Average Weight 40 C + 2 C & 75%RH 692.07mg 694.75mg 5% + 5% RH
Complies ° ° Identification Must Comply 40 C + 2 C & 75%RH Complies Complies + 5% RH
100.9% Assay (90-110% of 40°C + 2°C & 75%RH 99.64% 98.68% L.C) + 5% RH
(90.06— NLT 70% of ° ° (88.42--- (92.87--- 40 C + 2 C & 75%RH 95.03%) Dissolution labeled amount + 5% RH 96.09%) 96.55%) in 30min
Analyst signature (after completion of every time line) Conclusion by QA (after completion of the study )
Minutes for 257th Registration Board Meeting 242
STABILITY STUDY DATA SHEET
1.0 Product details:
Product name Generic Sovir 400mg tablets (Sofosbuvir) Batch No. P2 name/Dosage form
Description of pack Batch Size. 250 tablets (container closure system) 400mg film coated, yellow oblong tablet in HDPE bottle and CRC cap.
Parameters and tests mentioned As per Product Specifications Mfg. Date 06-2015
Recommended storage conditions Short term conditions (Accelerated) 40 ºC+ 2ºC, 75% ±5%RH Ex Date 06-2017 Long term conditions (Real time)30 ºC + 2ºC, 65% ±5% RH '
Date of initiation & implementation 26-06-2015 (API) lot no. AS0FC0415009
Stability No. STB-P02
Sample taken for physical tests = 30 Tab Sample taken for Chemical tests = 120 Tab Approval by: Sample taken for Microbiological tests = NA QC Manager Extra samples (if needed) = 35 Tab QA Manager Total Sample size (approx) = 185 Tab Production Manager: R&D Manager:
Assessment frequency (weeks) Initial I 2 3 4 6 8 12 16 20 24 26
Date of Testing 26-06-15 26-09-15 26-12-15
Minutes for 257th Registration Board Meeting 243
Mode of testing(F = Full. P= Partial testing) F F F
Tests (Physical. Storage Acceptance Chemical, conditions Criteria Microbiological)
Yellow Oblong
shaped film Complies Description coated tablets, one 30°C + 2°C & Complies Complies side CIRIN 65%RH + 5% RH engraved ,other side plane
2min
Disintegration Time NMT 30min 30°C + 2°C & 65%RH 2min 2min + 5% RH
692.5mg ° ° 695.86mg 689.3mg Average Weight 695mg/tab + 5% 30 C + 2 C & 65%RH + 5% RH
Complies 30°C + 2°C & 65%RH Complies Complies Identification Must Comply + 5% RH
Assay (90-110% of L.C) 30°C + 2°C & 101.8% 65%RH 101.01% 99.73% + 5% RH
(85.71--- NLT 70% of ° ° (87.30--- (88.50--- 30 C + 2 C & 65%RH 94.58%) Dissolution labeled amount + 5% RH 96.40%) 97.02% in 30min
Analyst signature (after completion of every time line) Conclusion by QA (after completion of the study )
Minutes for 257th Registration Board Meeting 244
Assessment frequency (weeks) Initial I 2 3 4 6 8 12 16 20 24 26
Date of Testing 26-06-15 26-09-15 26-12-15
Mode of testing(F = Full. P= Partial testing) F F F
Tests (Physical. Storage Acceptance Chemical, conditions Criteria Microbiological) (Accelerated)
Yellow Oblong
shaped film Complies Description coated tablets, 40°C + 2°C & 75%RH Complies Complies one side CIRIN + 5% RH engraved ,other
side plane
2min Disintegration NMT 30min 40°C + 2°C & 75%RH Time 2min 2min + 5% RH
695mg/tab + ° ° 692.5mg 694.81mg 688.28mg Average Weight 40 C + 2 C & 75%RH 5% + 5% RH
Complies ° ° Identification Must Comply 40 C + 2 C & 75%RH Complies Complies + 5% RH
101.8% Assay (90-110% of 40°C + 2°C & 75%RH 100.8% 99.39% L.C) + 5% RH
Minutes for 257th Registration Board Meeting 245
(85.71--- NLT 70% of ° ° (91.05---- (90.43--- 40 C + 2 C & 75%RH 94.58%) Dissolution labeled amount + 5% RH 92.22%) 96.54%) in 30min
Analyst signature (after completion of every time line) Conclusion by QA (after completion of the study )
STABILITY STUDY DATA SHEET
1.0 Product details:
Product name Generic Sovir 400mg tablets (Sofosbuvir) Batch No. P3 name/Dosage form
Description of pack Batch Size. 250 tablets (container closure system) 400mg film coated, yellow oblong tablet in HDPE bottle and CRC cap.
Parameters and tests mentioned As per Product Specifications Mfg. Date 06-2015
Recommended storage conditions Short term conditions (Accelerated) 40 ºC+ 2ºC, 75% ±5%RH Ex Date 06-2017 Long term conditions (Real time)30 ºC + 2ºC, 65% ±5% RH '
Date of initiation & implementation 29-06-2015 (API) lot no. AS0FC0415009
Stability No. STB-P03
Minutes for 257th Registration Board Meeting 246
Approval by: QC Manager Sample taken for physical tests = 30 Tab QA Manager Sample taken for Chemical tests = 120 Tab Production Manager: Sample taken for Microbiological tests = NA R&D Manager: Extra samples (if needed) = 35 Tab
Total Sample size (approx) = 185 Tab
Assessment frequency (weeks) Initial I 2 3 4 6 8 12 16 20 24 26
Date of Testing 29-06-15 29-09-15 29-12-15
Mode of testing(F = Full. P= Partial testing) F F F
Tests (Physical. Storage Acceptance Chemical, conditions Criteria Microbiological)
Yellow Oblong
shaped film Complies Description coated tablets, one 30°C + 2°C & Complies Complies side CIRIN 65%RH + 5% RH engraved ,other side plane
Disintegration Time NMT 30min 30°C + 2°C & 65%RH 3min 3min 3min + 5% RH
° ° 692.11mg 693.71mg 695.31mg Average Weight 695mg/tab + 5% 30 C + 2 C & 65%RH + 5% RH
30°C + 2°C & 65%RH Complies Complies Identification Must Comply Complies + 5% RH
Minutes for 257th Registration Board Meeting 247
30°C + 2°C & Assay (90-110% of L.C) 65%RH 102.77% 101.9% 99.41% + 5% RH
(85.86--- NLT 70% of ° ° (93.69--- (89.78---- 30 C + 2 C & 65%RH 93.55%) Dissolution labeled amount + 5% RH 100.3%) 94.23%) in 30min
Analyst signature (after completion of every time line) Conclusion by QA (after completion of the study )
Assessment frequency (weeks) Initial I 2 3 4 6 8 12 16 20 24 26
Date of Testing 29-06-15 29-09-15 29-12-15
Mode of testing(F = Full. P= Partial testing) F F F
Tests (Physical. Storage Acceptance Chemical, conditions Criteria Microbiological) (Accelerated)
Yellow Oblong
shaped film Complies Description coated tablets, 40°C + 2°C & 75%RH Complies Complies one side CIRIN + 5% RH engraved ,other
side plane
3min Disintegration NMT 30min 40°C + 2°C & 75%RH Time 3min 3min + 5% RH
695mg/tab + 92.11mg Average Weight 5% 40°C + 2°C & 75%RH 692.9mg 692.73mg + 5% RH
Minutes for 257th Registration Board Meeting 248
Complies ° ° Identification Must Comply 40 C + 2 C & 75%RH Complies Complies + 5% RH
102.77% Assay (90-110% of 40°C + 2°C & 75%RH 101.54% 98.99%
L.C) + 5% RH
(85.86--- NLT 70% of ° ° (89.66--- (85.25--- 40 C + 2 C & 75%RH 93.55%) Dissolution labeled amount + 5% RH 98.97% 93.56%) in 30min
Analyst signature (after completion of every time line) Conclusion by QA (after completion of the study )
Sr. No. Documents to be provided Status
1. COA of API Yes 2. Approval of API by regulatory authority of country of Yes (Photocopy origin or GMP certificate of API manufacturer issued by provided) regulatory authority of country of origin. 3. Protocols followed for conduction of stability study and Yes details of tests. 4. Data of 03 batches will be supported by attested Yes respective documents like chromatograms, laboratory reports, data sheets etc. 5. Documents confirming import of API etc. Yes
Minutes for 257th Registration Board Meeting 249
(ADC cleared) 6. All provided documents will be attested (name, sign and Yes stamp) for ensuring authenticity of data / documents. 7. Commitment to continue real time stability study till Yes assigned shelf life of the product.
Decision: Registration board discussed and evaluated the stability data submitted by the applicants in the light of recommendations of the Board finalized in 251st meeting. Board decided that the committee comprising Brig. Muzamil H.Najmi Member Registration Board (chairman of committee), Dr. Obaidullah, Secretary Registration Board and Dr. Saif- ur-Rehman Khattak, Federal Government Analyst, CDL, Karachi shall physically inspect the firm to ensure authenticity of stability data submitted by the applicant.
Minutes for 257th Registration Board Meeting 250
M/s Glitz Pharma Islamabad
Drug Sofosvir tablets (Sofosbuvir) 400 mg Source Jianxi Synergy Pharma Co. Ltd, Jiangxi Province China Storage Condition Real Time: 30 C and 75% RH Accelerated: 40 C and 75% RH Time Period Real Time: 6 months Accelerated: 6 months Frequency 0, 1,2,3, 6 months
Batch Size 500 tablets per batch. No. of Batches 03 Sample Size 37 tablets Meeting Deferred in 251st meeting of Registration Board scientifically rational lab scale data as per requirements decided in the meeting.
Product Details Product name/ Generic Sofosvir (Sofosbuvir) 400mg Tablets Batch No TT-01 name/ Dosage form Description of pack (container closure Bottles Bat size 500 Tablets system) Parameters and tests Description, Identification, Disintegration, Dissolution & Assay Mfg. Date 07-2015 mentioned Recommended storage . Short term conditions (Accelerated) 40◦C ±2◦C, 75%±5% RH Exp. Date 07-2017 conditions . Long term conditions (Real Time) 30◦C ±2◦C, 65%±5% RH
Minutes for 257th Registration Board Meeting 251
Date of initiation & (API) Lot 01-07-2015 YF20150401 implementation No Stability No. Doc. No.: GP / QC / SSP / 001
Sample taken for Physical tests = (6+6) = 12 Tablets Sample taken for Chemical tests = 20 Tablets Sample taken for Microbiological tests =N.A Extra Samples if needed = 5 Total sample size (approx) = 37 Tablets per test
Accelerated Stability Study Data Sheet After 01 After 02 After 03 After 06 Assessment frequency (weeks) Initial month months months months Date of Testing 01-07-15 01-08-15 01-09-15 01-10-15 01-01-16 Mode of testing (F= full, P= partial) F P F P F P F P F P Tests (Physical, Storage Acceptance Chemical, Conditions Criteria Microbiological) (Accelerated) Oblong
shape Description 40◦C ±2◦C, Complies Complies Complies Complies Complies white color 75%±5% tablets
Positive for Identification 40◦C ±2◦C, Positive Positive Positive Positive Positive Sofosbuvir 75%±5%
NMT 30 Disintegration 40◦C ±2◦C, 12.0 min 12.2 min 12.4 min 12.6 min 13.0 min min 75%±5%
Minutes for 257th Registration Board Meeting 252
NLT 85 % Dissolution in 30 40◦C ±2◦C, 99.15 % 98.14% 97.16% 96.15% 94.12% minutes 75%±5% NLT
90.0% and Assay 40◦C ±2◦C, 100.00 % 101.19 % 101.81 % 99.97 % 99.91 % NMT 75%±5% 110.0% Analyst Signature (after completion of every
time line) Conclusion by QA (after completion of the
study)
Real Time Stability Study Data Sheet After 06 After 09 Assessment frequency (weeks) Initial After 03 months months months Date of Testing 01-07-15 01-10-15 01-01-16 01-04-16 Mode of testing (F= full, P= partial) F P F P F P F P Tests (Physical, Storage Acceptance Chemical, Conditions Criteria Microbiological) (Accelerated)
Oblong shape Description 30◦C ±2◦C, Complies Complies Complies white color tablets 65%±5%
Positive for Identification 30◦C ±2◦C, Positive Positive Positive Sofosbuvir 65%±5%
Disintegration NMT 30 min 30◦C ±2◦C, 12.0 min 12.5 min 13.0 min 65%±5% Dissolution NLT 85 % in 30 99.15% 98.17% 97.19%
Minutes for 257th Registration Board Meeting 253
minutes 30◦C ±2◦C, 65%±5%
NLT 90.0% and Assay 30◦C ±2◦C, 101.49 % 100.03% 99.86% NMT 110.0% 65%±5% Analyst Signature (after completion of every time line) Conclusion by QA (after completion of the study)
Real Time Stability Study Data Sheet Post Expiry 01 Year Stability Study Assessment frequency (weeks) After 12 After 18 After 24 After 30 After 36 months months months months months Date of Testing 01-07-16 01-01-17 01-07-17 Mode of testing (F= full, P= partial) F P F P F P F P F P Tests (Physical, Acceptance Storage Chemical, Criteria Conditions Microbiological) (Accelerated) Description Oblong shape white color 30◦C ±2◦C, tablets 65%±5% Identification Positive for 30◦C ±2◦C, Sofosbuvir 65%±5% Uniformity of dosage units NMT 30 min 30◦C ±2◦C, 65%±5% Disintegration NLT 85 % in 30◦C ±2◦C, 30 minutes 65%±5% Dissolution NLT 90.0% and NMT 30◦C ±2◦C,
Minutes for 257th Registration Board Meeting 254
110.0% 65%±5% Assay Oblong shape white color 30◦C ±2◦C, tablets 65%±5% Analyst Signature (after completion of every time line) Conclusion by QA (after completion of the study)
Product Details Product name/ Generic Sofosvir (Sofosbuvir) 400mg Tablets Batch No TT-02 name/ Dosage form Description of pack (container closure Bottles Bat size 500 Tablets system) Parameters and tests Description, Identification, Disintegration, Dissolution & Assay Mfg. Date 07-2015 mentioned Recommended storage . Short term conditions (Accelerated) 40◦C ±2◦C, 75%±5% RH Exp. Date 07-2017 conditions . Long term conditions (Real Time) 30◦C ±2◦C, 65%±5% RH Date of initiation & (API) Lot 01-07-2015 YF20150401 implementation No Stability No. Doc. No.: GP / QC / SSP / 001
Sample taken for Physical tests = (6+6) = 12 Sample taken for Chemical tests = 20 Sample taken for Microbiological tests = N.A Extra Samples if needed = 5 Total sample size (Approx) = 37 Tablets Per Test
Minutes for 257th Registration Board Meeting 255
Accelerated Stability Study Data Sheet After 01 After 02 After 03 After 06 Assessment frequency (weeks) Initial month months months months Date of Testing 01-07-15 01-08-15 01-09-15 01-10-15 01-01-16 Mode of testing (F= full, P= partial) F P F P F P F P F P Tests (Physical, Storage Acceptance Chemical, Conditions Criteria Microbiological) (Accelerated) Oblong
shape Description 40◦C ±2◦C, Complies Complies Complies Complies Complies white color 75%±5% tablets
Positive for Identification 40◦C ±2◦C, Positive Positive Positive Positive Positive Sofosbuvir 75%±5%
NMT 30 Disintegration 40◦C ±2◦C, 11.7 min 11.9 min 12.1 min 12.3 min 12.7 min min 75%±5% NLT 85 % Dissolution in 30 40◦C ±2◦C, 99.99 % 98.97% 97.98% 96.95% 90.95% minutes 75%±5% NLT
90.0% and Assay 40◦C ±2◦C, 101.32 % 101.39 % 101.40% 99.71 % 99.82 % NMT 75%±5% 110.0% Analyst Signature (after completion of every
time line) Conclusion by QA (after completion of the
study)
Minutes for 257th Registration Board Meeting 256
Real Time Stability Study Data Sheet After 09 Assessment frequency (weeks) Initial After 03 months After 06 months months Date of Testing 01-07-15 01-10-15 01-01-16 01-04-16 Mode of testing (F= full, P= partial) F P F P F P F P Tests (Physical, Storage Chemical, Acceptance Criteria Conditions Microbiological) (Accelerated)
Oblong shape white Description 30◦C ±2◦C, Complies Complies Complies color tablets 65%±5%
Positive for Identification 30◦C ±2◦C, Positive Positive Positive Sofosbuvir 65%±5%
Disintegration NMT 30 min 30◦C ±2◦C, 11.7 min 12.2 min 12.7 min 65%±5%
NLT 85 % in 30 Dissolution 30◦C ±2◦C, 99.99 % 98.99% 97.97% minutes 65%±5%
NLT 90.0% and Assay 30◦C ±2◦C, 101.04 % 100.00 % 100.01% NMT 110.0% 65%±5% Analyst Signature (after completion of every time line) Conclusion by QA (after completion of the study)
Continued…
Real Time Stability Study Data Sheet
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Post Expiry 01 Year Stability Study Assessment frequency (weeks) After 12 After 18 After 24 After 30 After 36 months months months months months Date of Testing 01-07-16 01-01-17 01-07-17 Mode of testing (F= full, P= partial) F P F P F P F P F P Tests (Physical, Acceptance Storage Chemical, Criteria Conditions Microbiological) (Accelerated) Description Oblong shape white color 30◦C ±2◦C, tablets 65%±5% Identification Positive for 30◦C ±2◦C, Sofosbuvir 65%±5% Uniformity of dosage units NMT 30 min 30◦C ±2◦C, 65%±5% Disintegration NLT 85 % in 30◦C ±2◦C, 30 minutes 65%±5% Dissolution NLT 90.0% and NMT 30◦C ±2◦C, 110.0% 65%±5% Assay Oblong shape white color 30◦C ±2◦C, tablets 65%±5% Analyst Signature (after completion of every time line) Conclusion by QA (after completion of the study)
Product Details
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Product name/ Generic Sofosvir (Sofosbuvir) 400mg Tablets Batch No TT-03 name/ Dosage form Description of pack Bottles Bat size 500 Tablets (container closure system) Parameters and tests Description, Identification, Disintegration, Dissolution & Assay Mfg. Date 07-2015 mentioned Recommended storage . Short term conditions (Accelerated) 40◦C ±2◦C, 75%±5% RH Exp. Date 07-2017 conditions . Long term conditions (Real Time) 30◦C ±2◦C, 65%±5% RH Date of initiation & 01-07-2015 (API) Lot No YF20150401 implementation Stability No. Doc. No.: GP / QC / SSP / 001
Sample taken for Physical tests = (6+6) = 12 Sample taken for Chemical tests = 20 Sample taken for Microbiological tests = N.A Extra Samples if needed = 5 Total sample size (Approx) = 37 Tablets per test
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Accelerated Stability Study Data Sheet After 01 After 02 After 03 After 06 Assessment frequency (weeks) Initial month months months months Date of Testing 01-07-15 01-08-15 01-09-15 01-10-15 01-01-16 Mode of testing (F= full, P= partial) F P F P F P F P F P Tests (Physical, Storage Acceptance Chemical, Conditions Criteria Microbiological) (Accelerated) Oblong
shape Description 40◦C ±2◦C, Complies Complies Complies Complies Complies white color 75%±5% tablets
Positive for Identification 40◦C ±2◦C, Positive Positive Positive Positive Positive Sofosbuvir 75%±5%
NMT 30 Disintegration 40◦C ±2◦C, 12.0 min 12.2 min 12.4 min 12.6 min 13.0 min min 75%±5% NLT 85 % Dissolution in 30 40◦C ±2◦C, 100.05 % 99.03% 98.0% 97.01% 89.05% minutes 75%±5% NLT
90.0% and Assay 40◦C ±2◦C, 101.66 % 101.06 % 100.94 % 99.78% 100.04% NMT 75%±5% 110.0% Analyst Signature (after completion of every
time line) Conclusion by QA (after completion of the
study)
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Real Time Stability Study Data Sheet After 09 Assessment frequency (weeks) Initial After 03 months After 06 months months Date of Testing 01-07-15 01-10-15 01-01-16 01-04-16 Mode of testing (F= full, P= partial) F P F P F P F P Tests (Physical, Storage Chemical, Acceptance Criteria Conditions Microbiological) (Accelerated)
Oblong shape white Description 30◦C ±2◦C, Complies Complies Complies color tablets 65%±5%
Positive for Identification 30◦C ±2◦C, Positive Positive Positive Sofosbuvir 65%±5%
Disintegration NMT 30 min 30◦C ±2◦C, 12.0 min 12.5 min 13.0 min 65%±5%
NLT 85 % in 30 Dissolution 30◦C ±2◦C, 100.05 % 99.02% 98.02% minutes 65%±5%
NLT 90.0% and Assay 30◦C ±2◦C, 101.22 % 99.99% 99.97% NMT 110.0% 65%±5% Analyst Signature (after completion of every time line) Conclusion by QA (after completion of the study)
Continued…
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Real Time Stability Study Data Sheet Post Expiry 01 Year Stability Study After 12 After 18 After 24 After 30 After 36 Assessment frequency (weeks) months months months months months Date of Testing 01-07-16 01-01-17 01-07-17 Mode of testing (F= full, P= partial) F P F P F P F P F P Tests (Physical, Storage Acceptance Chemical, Conditions Criteria Microbiological) (Accelerated) Oblong shape Description white color 30◦C ±2◦C, tablets 65%±5%
Positive for Identification 30◦C ±2◦C, Sofosbuvir 65%±5%
Uniformity of NMT 30 min 30◦C ±2◦C, dosage units 65%±5%
NLT 85 % in Disintegration 30◦C ±2◦C, 30 minutes 65%±5% NLT 90.0% Dissolution and NMT 30◦C ±2◦C, 110.0% 65%±5% Oblong shape Assay white color 30◦C ±2◦C, tablets 65%±5% Analyst Signature (after completion of every time line) Conclusion by QA (after completion of the study)
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Sr. No. Documents to be provided Status (Glitz, Islamabad) 1. COA of API Yes 2. Approval of API by regulatory authority of country of Yes (Photocopy origin or GMP certificate of API manufacturer issued by provided) regulatory authority of country of origin. 3. Protocols followed for conduction of stability study and Protocol is not as per details of tests. new data requirements decided in 251st meeting. 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. Only airway bill provided 6. All provided documents will be attested (name, sign and Yes stamp) for ensuring authenticity of data / documents. 7. Commitment to continue real time stability study till Yes assigned shelf life of the product.
Decision: Registration board discussed and evaluated the stability data submitted by the applicants in the light of recommendations of the board finalized in 251st meeting. Board decided that the committee comprising Brig. Muzamil H. Najmi Member Registration Board (chairman of committee), Dr. Obaidullah, Secretary Registration Board and Dr. Saif-ur- Rehman Khattak, Federal Government Analyst, CDL, Karachi shall physically inspect the firm to ensure authenticity of stability data submitted by the applicant
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M/s Atco Karachi Drug Buvir tablets (Sofosbuvir) 400 mg Source Optimus Drugs Ltd Hyderabad, India Storage Condition Real Time: 30 C and 75% RH Accelerated: 40 C and 65% RH Time Period Real Time: 6 months Accelerated: 6 months Frequency 0, 3, 6 months
Batch Size 250, 250, 210 tablets . No. of Batches 03 Sample Size 40 tablets (Sample size doesn’t correspond to the batch size for continuing stability studies till the assigned shelf life). Meeting Deferred in 244th and 251st meeting of Registration Board. Sr. No. Documents to be provided Status (M/s Atco, Karachi) 1. COA of API Yes 2. Approval of API by regulatory authority of country of No origin or GMP certificate of API manufacturer issued by regulatory authority of country of origin. 3. Protocols followed for conduction of stability study and Yes details of tests. 4. Data of 03 batches will be supported by attested Complete data is not respective documents like chromatograms, laboratory submitted reports, data sheets etc. 5. Documents confirming import of API etc. No 6. All provided documents will be attested (name, sign and Yes stamp) for ensuring authenticity of data / documents. 7. Commitment to continue real time stability study till No assigned shelf life of the product. Decision: Registration Board deferred the case for complete data as per requirements of the Board as defined in 251st meeting and for clarification on relevancy of sample size and batch size produced by the firm.
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Miscellaneous cases:
Registration-II
Case No. 01 Registration of Drugs for export purpose. Following firms have requested for registration of following drugs for export purpose only which are not me-too & are new drugs. Details are as under:-
S. Name of Name of Product(s) Date of Approval No. Company application, status by Diary No. & reference Form regulatory authorities 1 M/s Getz Cuverol–L 90mg + 400mg 31.12.2015 Approved by Pharma, 29- Tablets 1231 US-FDA 30/27, Korangi Each film coated tablet contains: Rs. 20,000/- Industrial Area, Ledipasvir………………90mg 01.02.2016 Karachi Sofosbuvir…………….400mg Rs. 30,000/- 2 -do- Fledivir 90mg + 400mg Tablets 31.12.2015 Approved by Each film coated tablet contains: 1230 US-FDA Ledipasvir………………90mg Rs. 20,000/- Sofosbuvir…………….400mg 01.02.2016 Rs. 30,000/-
Decision: Registration Board approved grant of registration of above products for export purpose only.
Case No.02: Deferred cases. a) Registration of products of M/s Safe Pharmaceuticals (Pvt) Ltd., Karachi Registration Board in its 246th meeting deferred the following applications of M/s Safe Pharmaceutical, Plot # C-1-20, Sector 6-B, North Karachi Industrial Area, Karachi for the reason stated in the last column:
S. No. Name of firm Name of Drug(s) Pack MRP Decision
1. M/s Safe Magadol Drops 10ml As per PAC Registration Pharmaceutic Each ml contains:- Board deferred als, Karachi Tramadol HCl ………2.5mg the case for (Non Narcotic Analgesic) evaluation of registration application as per approved check list Minutes for 257th Registration Board Meeting 265
2. -do- Magadol Capsule 1x10’s As per PAC -do- Each capsule contains:- Tramadol HCl ………50mg (Non Narcotic Analgesic)
Now the firm has provided the evidence of approval of liquid syrup section (general) and Capsule (general) sections from Central Licensing Board. Decision: Registration Board approved registration of Magadol Drops and Magadol Capsules for M/s Safe Pharmaceuticals, Karachi.
b) Registration Board in its 235th meeting has deferred the following applications of M/s Medicaids Pakistan Pvt Ltd., Plot No. 10, Sector 27, Korangi Industrial Area, Karachi for the reason stated in the last column:
S.No Name of firm Name of Drug(s) & Pack size MRP Decision of compositon 235th DRB 1 M/s Medicaids Loton Ophthalmic 5ml Rs.650.00 Deferred. Pakistan Pvt Suspension Separate section Ltd., Plot No. Each ml contains:- required for 10, Sector 27, Loteprednol steroidal Korangi Etabonate……….…5mg preparations. Industrial Area, (Ophthalmic Steroid Karachi Preparation) 2 -do- Tobol Ophthalmic 5ml Rs.650.00 Deferred. Suspension Separate section Each ml contains:- required for Letoprednol steroidal Etabonate…………5mg preparations. Tobramycin ..…...3mg (Anti bacterial + Ophthalmic Steroid Preparation)
Now, the firm has submitted an undertaking in the light of decision of the Registration Board taken in its 246th on company letter head. Decision: Registration Board approved registration of Loton Ophthalmic Suspension and Tobol Ophthalmic Suspension for M/s Medicaids Pakistan, Karachi.
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Case No.03: Correction in the minutes of M-254th meeting of Registration Board The Registration Board in its 254th meeting approved the following products Sl. No.1 & 2 which are currently registered in the name of Macter International Karachi and Sl. No. 3 in the name of M/s Opal Pharma, Karachi. Previously these products were deferred by the Registration Board in its M-250th meeting for confirmation of availability of formulation in reference drug agencies. Inadvertently in the 2nd last column meeting number of Registration Board was mistakenly mentioned as 249 instead of 250. Similarly the last column mentioned the heading of International Availability instead of decision as below: Sr. No Name of Product Me-Too Status Decision-249 International Availability 10. Costa 2% Syrup 1. Rhinathiol Deferred for Approved Each 5ml contains: 2%, confirmation of Carbocisteine………. (Sanofi avail ability of (Rhinathiol Syrup 100mg Aventis) formulation in of Sanofi Aventis (Manufacturer’s 2. Carbex reference drug France. Ref: Specification) (Platinum) agencies approved ANSM France) 3. Muflex in 249th meeting (Kaizen) of Registrtion Contraindicated 4. Rhinex Board. below two years (Opal) of age. The local package insert for Rhinathiol 2% syrup (for all existing and new manufactrers) will be updated to reflect this new contraindication. Ref: ANSM France Costa Pro Syrup 1. Rhinathiol Deferred for Approved 11. Each 5ml contains: Prometh confirmation of Carbocisteine …….. (Sanofi- availability of (Rhinathiol 100mg Aventis) formulation in Promethazine Promethazine HCl…. 2. Rhinex-P reference drug Syrup of Sanofi 2.5mg (Opal) agencies approved Aventis France. (Manufacturer’s 3. Carbex plus in 249th meeting Ref: ANSM Specification) (Platinum) of Registrtion France) 4. Muflex Pro Board. (Kaizen) Contraindicated below two years of age. The local package insert for Minutes for 257th Registration Board Meeting 267
Rhinathiol 2% syrup (for all existing and new manufactrers) will be updated to reflect this new contraindication. Ref: ANSM France 12. Buterol oral solution 1. Btno oral Deferred for Approved Each 5ml contains: solution confirmation of Bambuterol HCl….. 5mg (Genix) availability of (Bambec Oral (Manufacturer’s 2. Bambuzaf formulation in solution 1mg/ml. Specification) (Zafa) reference drug Ref: bFARM 3. Butral agencies approved Germany) (Shaheen) in 249th meeting 4. Pulmitac of Registrtion (Platinum) Board. 5. Pulmiterol (Kaizen) 6. Ordain (SJ&G) 7. Bambac (Opal) 8. Bambia (MKB)
Registration Board is requested for correction in its minutes of 254th meeting as detailed above. These products have been approved by Registration Board in its 254th meeting in connection with the request of M/s Hiranis Pharmaceutical Karachi for registration of these products from M/s Macter International Karachi and M/s Opal Pharma, Karachi to their name. Decision: Registration Board approved proposed corrections.
Case No.04 Change in Registration of products of M/s GSK from F. 268 site to Korangi site (site change)
M/s GlaxoSmithKlin Pakistan Limited 35, Dockyard Road, West Wharf, Karachi has requested for transfer of registration of following products from their site F- 268 (DML NO. 000233) to Korangi site (DML 000248): S.# Product for registration with generic Reg. Renewal Remarks name No. up to 1. Chewcal Tablet, 019881 08.09.2018 - Each tablet contains: Minutes for 257th Registration Board Meeting 268
Elemental Calcium BP……………400mg Vitamin D………………………..2.5mcg 2. Starvits Tablet 019882 28.08.2018 Each tablet contains: Vitamin A. BP…………………..400mcg Vitamin D. BP……………………...5mcg Vitamin C. BP……………………...30mg Thiamin (Vitamin B1)BP………….0.7mg Riboflavin (Vitamin B2)BP…….....0.8mg Pyridoxine (Vitamin B6)BP…………1mg Vitamin B12 BP……………………1mcg Iron BP…………………………..…..7mg 3. Revitale B Tablets. 019883 28.08.2018 Each tablet contains: Thiamin (Vitamin B1).BP…...…….2.8mg Riboflavin (Vitamin B2).BP……....3.2mg Niacin. BP………………………….36mg Vitamin B6. BP………………...... …4mg Folacin (Folic Acid). BP……...…400mcg Vitamin B12. BP…………….…….2mcg Biotin. BP…………………….….0.15mg Pantothenic Acid. BP……………...12mg Choline……USP…………………..10mg Inosital…….BP……………………10mg 4. Revitale Multi Tablets 019884 28.08.2018 Each tablet contains: Vitamin A. BP…………………..800mcg Vitamin D. BP…………………..…5mcg Vitamin E. BP…………………..…10mg Vitamin C. BP…………………..…60mg Thiamin (Vitamin B1)BP…………1.4mg Riboflavin (Vitamin B2)BP……....1.6mg Niacin. BP…………………………18mg Vitamin B6. BP……………………..2mg Folacin (Folic Acid) BP…………200mcg Vitamin B12. BP…………………..1mcg Biotin. BP…………………….….0.15mg Pantothenic Acid. BP……………….6mg Calcium. BP……………………….80mg Iron. BP……………………………14mg Magnesium. BP…………….……..14mg Zinc. BP…………………….…….7.5mg Iodin. BP…………………….…...150mg Chromium. USP………………….25mcg Selenium. BP……………………..25mcg
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The firm have provided following documents in support of their request as per approved SOP: 1) Application with form 5 and requirement fee amounting to Rs. 20,000/-. 2) Copy of registration letter with renewal status 3) Copy of evidence of Section as revealed by the panel inspection report for renewal of DML of new site. 4) Copy of NOC for CRF Clearance. 5) Copy of last inspection report. 6) Undertaking to conduct stability studies and validation of testing methods before marketing of the products.
Decision: Registration Board decided as follows: 1. Cancellation of registrations of product from M/s GSK Pharmaceuticals (Pvt) Ltd., F-268, Karachi (DML NO. 000233). 2. Registration of products in the name of to GSK Pharmaceuticals (Pvt) Ltd., Korangi site, Karachi (DML 000248). 3. Registration Board authorized its Chairman for issuance of registration letters after MRP fixation by Cost & Pricing Division.
Case No. 5 Deferred cases of Registration of Drugs for export purpose - Not me too (New Drugs) Registration Board deferred the following applications of applicants who applied for registration of drugs for export purpose only for the reasons since they were not approved in reference drug agencies. The Registration Board decided in its previous meeting for final decision on such cases which were previously being approved just on the provision of export order from the importing country.
S. Name of Name of product(s) Date of Import Order Approval status No. Company application by reference , Diary No. regulatory & Form authorities 1. M/s Pharmatec Reltus C&F Capsules 24.07.2015 Copy of import 1. Formulation Pakistan (Pvt) Each capsule contains: 120 Order from is present in India Ltd., Karachi Paracetamol………..300mg Rs. 20,000/- Cambodia in Tablet. Phenylephrine HCl…..5mg 2. Already Chlorpheniramine registered in Maleate…4mg Pakistan for export Caffeine of Pharmatec with Anhydrous….30mg name of Fludol (Reg. No.004098).
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2. Amarant Flurant DM Syrup 25.06.2015 Not provided by Pharmaceutical Each 5ml contains 421 Firm , Karachi. Dextromethorphan Rs. 20,000/- HBr….10 mg Pseudoephedrine HCl…….30 mg Chlorpheniramine Maleate...2 mg 3. -do- Flurant Capsule 25.06.2015 Not provided by Each capsule contains: 422 Firm Paracetamol Rs. 20,000/- BP…………300mg Pseudoephedrine HCl USP...30mg Caffeine Anhydrous BP….. 30mg Chlorpheniramine Maleate BP………..….4mg 4. Sami Trimetabol Oral Solution 08.06.2015 Copy of import Approved by Pharmaceutical Each 100ml contains 243 Order from regulatory , Karachi Cyproheptadine Acefilinate Rs. 20,000/- Switzerland authority of Spain (Metopine®)………35mg L-lysine HCl…………..5g DL-Carnitine HCl…….7.5g Thiamine HCl (Vitamin B1)………………600mg Pyridoxine HCl. (vitamin B6)…………………600mg Cyanocobalamin (vitamin B12)………….20mg
5. Hilton Pharma, Hilto-D 7.5mg Injection 22.09.2015 -do- Not provided by KARACHI. Each ml contains 940 Firm Vitamin D3 Rs. 20,000/- (Cholecalciferol)……7.5mg (300,000IU) 6. -do- Hilto – D Drop 22.09.2015 -do- Not provided by Each ml contains 942 Firm Vitamin D3 Rs. 20,000/- (Cholecalciferol)…….400I U 7. M/s. Medisure Accemide Injection 1ml 13.07.2015 Export order Not Found Laboratories ampoule Rs.20000/- not provided Pakistan (Pvt.) Each ml contains Limited Furosemide………..10mg A-115, S.I.T.E., Super Highway
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Karachi.
8. -do- Acce-Cee Injection 2ml 13.07.2015 -do- Not Found ampoule Rs.20000/- Each ml contains Ascorbic acid………500mg
9 M/s Pharmatec Flu-Gone day & night 06.11.2015 Copy of export Not Found Pakistan (Pvt) Capsules 963 order from Ltd., D-86/A, Each combi pack contains: Rs. 20,000/- Nairobi Kenya S.I.T.E., Day – time Capsule: 09.11.2015 Karachi Paracetamol………..500mg Rs. 30,000/- Pseudoephedrine HCl...... 30mg Caffeine Anhydrous…..30mg Night –time Capsule: Paracetamol……….500mg Pseudoephedrine HCl….30mg Citirizine (as dihydrochloride…….10mg Dextromethorphan HBr………………..10mg 10 M/s Hiranis Glimbax Mouthwash 06.11.2015 Copy of export In Italy in 200 ml Pharmaceutical 0.074% 964 order from , D-41, Block Each 100ml contains: Rs. 50,000/- Mynmar – 4, Clifton Diclofenac Acid…0.074% Karachi (Manufacturer Specification) 11 -do- Kop Mouthwash 1.6% 06.11.2015 -do- In 150 ml Each 100ml contains: 965 Ketoprofen (as lysine salt) Rs. 50,000/- …..1.6mg (manufacturer Specification -do- Dentifen Mouthwash 0.25% 06.11.2015 -do- In Turkey in 200 12 Each 100ml contains: 966 ml Flurbiprofen………0.25gm Rs. 50,000/- (Manufacturer Specification) M/s Bosch Cebosh 100mg Sachet 07.05.2014 Copy of Not Found 13 Pharmaceutical Each sachet contains: 980 Export order (Pvt) Ltd., Cefixime (as Rs. 20,000/- from veitnam Bosch House trihydrate)…..10mg 221, Sector 23, Korangi Industrial Area, Karachi
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14 M/s Hilton Tetravir Tablets 09.11.2015 Copy of USFDA Pharma (Pvt) Each film coated tablet 990 Export order Ltd., Plot No. contains: Rs. 50,000/- from 13/14, Sector Ombitasvir………12.5mg Afghanistan 15, Korangi Paritaprevir…..……75mg Industrial Ritonavir……………50mg Area, Karachi Each film coated tablet contains: 270.3mg dasabuvir sodium monohydrate eq to dasabuvir…………...250mg
Decision: Registration Board decided as follows: Approved items at S.No. 14, as it is USFDA approved. For items at S.No.01-13, Registration Board advised applicants to deposit remaing fee and provide approval status by regulatory authority of importing country and authorized Chairman for grant of registration. Registration Board will be informed accordingly.
Case No. 6 Correction in the name of firm wrongly typed in the minutes of 254th meeting of Registration Board.
Registration Board in its 254th meeting has approved following products of M/s Medisure Laboratories, Karachi in the name of M/s Hilton Pharma, Karachi mistakenly which are again submitted before the Board for correction in the name of applicant as per following detail:
Medisure Medilyza tablet 20.01.2015 Copy of USFDA Laboratories, Each film coated tablet 910 import Order approved Karachi contains: Rs. 20,000/- from Sri Saxagliptin (as Lanka hydrochloride)………..5mg -do- Medjenta tablet 20.01.2015 USFDA Each film coated tablet 911 approved contains: Rs. 20,000/- Linagliptin………..5mg
Decision: Registration Board approved Medilyza tablet for export registration purpose in favor of M/s Medisure Laboratories, Karachi. However, Medjenta tablet was deferred due to observation of representative of IPO in 255th meeting on registration of Linagliptin and Linagliptin + Metformin formulations.
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Case No.07: Registration of drugs for new section. 7 products of M/s Reign Pharmaceutical, Karachi have been considered by the Registration Board in its previous meetings and the three products still remained for the tablet general section. Since these following products were deferred by the Registration Board before creation of the Pharmaceutical Evaluation Cell, these are submitted for consideration by the Registration Board: -
S.# Name of Drug(s) with composition Demanded Demanded Status in pack size price reference agency 1. Gemlox Tablet As per PRC As per US-FDA Each tablet contains: (FDA) PRC Gemifloxacin (as mesylate)…..320mg (Quinolone) 2. PBSIL Tablet As per PRC As per US-FDA Each tablet contains: (FDA) PRC Piroxicam beta cyclodextrin……………….....20mg (NSAID) 3. Renflox Tablet As per PRC As per US-FDA Each tablet contains: (FDA) PRC Ciprofloxacin (as hydrochloride)…...... 250mg
The firm have provided the evidence of submission of remaining Rs. 12,000/- for each products Decision: Registration Board approved registration of Gemlox Tablet, PBSIL Tablet and Renflox Tablet for M/s Reign Pharmaceutical, Karachi.
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Case No. 8 Contract manufacturing of already registered products M/s Getz Phama (Pvt) Ltd., 29-30/27, Korangi Industrial Area, Karachi has requested for contract manufacturing of their following already registered products from M/s CSH, Lahore. S.# Applicant Contract Regn No. Name of drug(s) with composition Date and diary manufacturer 1) M/s Getz Phama M/s CSH 070732 Amclav 62.5mg/ml Drops 14.01.2016 (Pvt) Ltd., 29- Pharmaceutical (Pvt) Each ml of reconstituted suspension DyNo.11 30/27, Korangi Ltd., 32-KM contains: Rs.50,000/- Industrial Area, Ferozepur Road, Amoxicillin trihydrate eq. to 12.01.2016 Karachi Lahore Amoxicillin………………..50mg Clavulanic Acid potassium eq to Calvulanic Acid………..12.50mg (USP Specification) 2) -do- -do- 070731 Amclav 457mg/ml dry Suspension 14.01.2016 Each reconstituted 5ml suspension Dy No.13 contains: Rs.50,000/- Amoxicillin trihydrate eq. to 12.01.2016 Amoxicillin………………..400mg Clavulanic Acid potassium eq to Calvulanic Acid………..57mg (USP Specification) 3) -do- -do- 070729 Amclav 156.25mg/ml Dry 14.01.2016 Suspension Dy No.12 Each reconstituted 5ml suspension Rs.50,000/- contains: 12.01.2016 Amoxicillin trihydrate eq. to Amoxicillin………………..125mg Clavulanic Acid potassium eq to Calvulanic Acid………..31.25mg (USP Specification) 4) -do- -do- 070730 Amclav –DS 312.5mg/ml 14.01.2016 Suspension Dy No.07 Each reconstituted 5ml suspension Rs.50,000/- contains: 12.01.2016 Amoxicillin trihydrate eq. to Minutes for 257th Registration Board Meeting 275
Amoxicillin………………..250mg Clavulanic Acid potassium eq to Calvulanic Acid………..62.50mg (USP Specification) 5) -do- -do- 070725 Amclav 375.5mg tablet 14.01.2016 Each film coated tablet contains:: Dy No.08 Amoxicillin trihydrate eq. to Rs.50,000/- Amoxicillin………………..250mg 12.01.2016 Clavulanic Acid potassium eq to Calvulanic Acid………..125mg (USP Specification) 6) -do- -do- 070726 Amclav 625mg tablet 14.01.2016 Each film coated tablet contains:: Dy No.09 Amoxicillin trihydrate eq. to Rs.50,000/- Amoxicillin………………..500mg 12.01.2016 Clavulanic Acid potassium eq to Calvulanic Acid………..125mg (USP Specification) 7) -do- -do- 070727 Amclav 1000mg tablet 14.01.2016 Each film coated tablet contains:: Dy No.10 Amoxicillin trihydrate eq. to Rs.50,000/- Amoxicillin……………….875mg 12.01.2016 Clavulanic Acid potassium eq to Calvulanic Acid………..125mg (USP Specification)
The firm have provided following documents as per requirements of SOP. i) Application on form 5-A, alongwith fee amounting to Rs. 50,000/- for each product ii) Agreement of CSH, Lahore with Getz, Karachi. iii) Approval of penicillin manufacturing for tablet, capsule and dry powder for suspension by CLB. iv) GMP certificate of CSH dated 24.11.2014.
Decision: Registration Board approved contract manufacturing of above products from M/s CSH Pharmaceuticals, Lahore in light of Rule 20 A of Drugs (L,R & A) Rules, 1976.
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Registration – III Case No. 09 Registration of Drugs for export purpose - Not me too (New Drugs) Grant of export registration. M/s Unimark Pharmaceuticals, Islamabad have requested for registration of following drug for export purpose only which is non me-too & is new drug. Details are as under:-
Name of Name of product(s) Date of Import Order Approval Company application, status by Diary No. & reference Form regulatory authorities M/s Unimark Carsel XL-25 Tablet 29.12.2014 Copy of export Sweden Pharmaceuitcals, Each film coated extended 865 order from Plot No.7-A, released tablets contains: Rs. 20,000/- Afghanistan. Street, S-7, Metoprolol succinate National USP………..23.75mg Industrial Zone, Eaqualient to Metoprolol Rawat, Islamabad tartrate………...25mg
Decision: Registration Board approved Carsel XL-25 Tablet for registration.
Case No. 10 Deferred cases of Registration of Drugs for export purpose - Not me too (New Drugs)
Registration Board deferred the following applications of applicants who applied for registration of drugs for export purpose only for the reasons since they were not approved in reference drug agencies. The Registration Board decided in its previous meeting for final decision on such cases which were previously being approved just on the provision of export order from the importing country.
1. M/s Pedikulin Shampoo 120ml As Per 04-11-2015 Copy The firm has Caraway 1% SRO Dy.No.1922 of provided Pharmaceu Each 100ml Fee export evidence of ticals contains:- Rs.20,000/= order approval of Rawat Permethrin….1gm from the Islamabad. Tajikist formulation an in UK
Decision: Registration Board advised applicants to deposit remaining fee and provide approval status by regulatory authority of importing country and authorized Chairman for grant of registration. Registration Board will be informed accordingly.
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Registration-V Case No.11 Export of Non Me-Too Product
a. M/s. CCL Pharmaceuticals (Pvt.) Ltd; Lahore
M/s. CCL Pharmaceuticals (Pvt.) Ltd; Lahore has requested for registration of following product for export purpose only:-
S. No Name of Products 1. Filgap Tablet Each tablet contains: Empagliflozin……..25mg 2. Dapet Tablet 60mg Each tablet contains: Dapoxetine hydrochloride equivalent to Dapoxetine…….60mg 3. Filgap Tablet Each tablet contains: Empagliflozin……..10mg 4. Dapet Tablet 30mg Each tablet contains: Dapoxetine hydrochloride equivalent to Dapoxetine…….30mg 5. Hartin ER Tablet 750mg Each extended release tablet contains: Ranolazine…………..750mg,(CCL Specs) 6. Hartin ER Tablet 375mg Each extended release tablet contains: Ranolazine…………..375mg,(CCL Specs) 7. Loglip Tablet 25mg Each Tablet contains: Alogliptin Benzoate equivalent to Alogliptin……….25mg,(CCL Specs) 8. Loglip Tablet 12.5mg Each Tablet contains: Alogliptin Benzoate equivalent to Alogliptin……….12.5mg,(CCL Specs) 9. Loglip Tablet 6.25mg Each Tablet contains: Alogliptin Benzoate equivalent to Alogliptin……….6.25mg,(CCL Specs)
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10. Enmir Tablet 800mg Each tablet Contains: Sevelamer Carbonate……800mg 11. Once A Day AX Tablet Each tablet Contains: Vitamin E…………125mg Vitamin C………125 Vitamin A (as Acetate & Beta-Carotene)..9mg Zinc……………………….7.5mg Cooper………………1.0mg Selenium……………15.0mcg Manganese…………..1.5mg
The firm has submitted the following documents. a. Fee of Rs. 20000/- each product for this purpose. b. Form-5. c. Copy of GMP inspection. d. Export orders. c. NOC for CRF. e. Approval of section by CLB.
Decision: Registration Board decided as follows: Approved item at S.No.1-10 for registration as approved by reference regulatory authorities. Firm will deposit remaining fee (Rs.30000/-) per product and Chairman, Rregistration Board will permit issuance of registration letter.
For items at S.No.11, Registration Board advised applicants to deposit remaing fee and provide approval status by regulatory authority of importing country and authorized Chairman for grant of registration. Registration Board will be informed accordingly.
b. M/s. Wilshire Laboratories (Pvt.) Ltd; Lahore
M/s. Wilshire Laboratories (Pvt.) Ltd; Lahore has requested for registration of following product for export purpose only:-
S. No Name of Products 1. Ziqar Plus Each Film coated tablet contains: Sofosbuvir…….400mg Ledipasvir………90mg
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The firm has submitted the following documents. a. Fee of Rs. 20000/- each product for this purpose. b. Form-5. c. Copy of GMP inspection. d. Export orders. c. NOC for CRF. e. Approval of section by CLB.
Decision: Registration Board approved registration of above product exclusively for export purpose
c. M/s. Sharooq Pharmaceutical (Pvt) ltd; Lahore
M/s. Sharooq Pharmaceutical (Pvt) ltd; Lahore has requested for registration of following product for export purpose only:-
S. No Name of Products 1. Valdis Plus Tablets 400mg/90mg Each Film coated tablet contains: Sofosbuvir…….400mg Ledipasvir………90mg 2. Ledivir Tablets 400mg/90mg Each Film coated tablet contains: Sofosbuvir…….400mg Ledipasvir………90mg 3. Fosuvir Tablets 400mg Each Film coated tablet contains: Sofosbuvir…….400mg
The firm has submitted the following documents. a. Fee of Rs. 20000/- each product for this purpose. b. Form-5. c. Copy of GMP inspection. d. Export orders. c. NOC for CRF. e. Approval of section by CLB.
Decision: Registration Board approved registration of above product exclusively for export purpose.
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d. M/s. Novamed Pharmaceutical (Pvt) Ltd; Lahore
M/s. NovaMed Pharmaceutical (Pvt) ltd; Lahore has requested for registration of following product for export purpose only:- S. No Name of Products 1. Tadalafil 20mg Tablets Each Film coated tablet contains: Tadalafil…….20mg
The firm has submitted the following documents. a. Fee of Rs. 20000/- each product for this purpose. b. Form-5. c. Copy of GMP inspection. d. Export orders. c. NOC for CRF. e. Approval of section by CLB.
Decision: Registration Board deferred the product till decision on registration of Erectile dysfunction (PDE Inhibitors).
Case No. 12: Registration of drug applied on fast track basis.
It is submitted that various firms / new license manufacturers apply for registration as per criteria/procedure of ten (10) products per section. In the meanwhile there are cases where many firms/manufacturers had also obtained registrations on fast track basis (out of queue) in the past. Such firms are of the view that they may be issued registration letters of fast track applications separately and these registrations should not have been mixed with the quota of 10 registrations per section.
Decision: Registration Board deferred the case for further deliberation in next meeting.
Case No.13 Registration Application of M/s. CCL Pharmaceutical, Lahore deferred in 255th meeting.
The Registration Board in its 255th Meeting has deferred the following product of M/s CCL Pharmaceutical, Lahore for confirmation of approval status of reference regulatory authorities:-
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S.NO Name of the drugs with Pack Experts. Comments of the composition Size experts 1. Virata Tablet 90mg As Per 1. Prof. Dr. This drug is already Each Tablet contains: brand Mehmood Ahmed approved by FDA and Ticagrelor……..90mg leader Dean, Faculty of is well tolerated, (Platelet Inhibitor) /20’s Pharmacy and effective and safe. alternative medicine, Dissolution data, University of complete stability Bahawalpur. profile are not mentioned. The data regarding cost effectiveness/price of Virate Tablet and its comparison with existing products is also not mentioned Therefore, keeping in view the above mentioned facts; the registration of above mentioned product can be given subject to satisfactorily Provision of dissolution, stability and cost effectiveness data of the product. 2. Prof. Dr. Asad Keeping in view the Riaz Kitchlew Head various studies of the department of conducted for the said cardiology PIMS drug and worldwide Islamabad. status of the drug, it is strongly recommended for Registration. However, Price may be decided as per policy 3. Brig. Aslam Khan, Awaited. M.H Rawalpindi
Now the firm has submitted that subject drug is approved by USFDA with the name of “Brilinta” in the name of AstraZeneca LP. It is further submitted that the registration board in its 250th meeting had taken following decision in the subject matter:-
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“Registration Board discussed the requirement of taking expert opinion and deliberated that it is not mandatory to take expert opinion about a molecule/ formulation, if it is already approved (in same dosage form and strength) by regulatory agency of any of the reference country viz. USFDA, Health Canada, EMA, TGA Australia, PMDA Japan, MHRA United Kingdom, Germany, France, Switzerland, Netherlands, Austria, Denmark, Sweden and Norway. However Registration Board can take views / opinion of experts (if requires) regarding safety and efficacy parameters of the drug under domestic circumstances / practices, risk-benefit ratio in light of existing therapies etc.”
Submitted for orders of Registration Board in view of the procedure define in 250th meeting in respect of expert opinion. Decision: Registration Board deferred the case for scientifically rationale lab scale stability data in the light of recommendations of the Board in 251st meeting.
Case No.14 Transfer of Registration from M/s. Obson Pharma Lahore to M/s. Synchro Pharma Lahore.
Registration Board in its 246th Meeting canceled the registration of following products from M/s. Obson Pharma Lahore and registered in the name of M/s. Synchro Pharma Lahore for the following products and decision was taken as follows:-
S.No Name of drugs with composition Reg. No Initial date of Registration and valid date 1. Obdin Tablet 5mg 059991 10-09-2009 Each tablet contains:- Valid until Desloratadine ………….. 5mg 9-9-2014 2. Azrocin Suspension 025404 11-11-1999 Each 5ml contains:- Valid until Azithromycinm dihydrate eq. to 10-11-2014 Azithromycin …….. 200mg 3. Obflox Tablet 054157 19-02-2009 Each tablet contains:- Valid until Levofloxacin Hemihydrate 18-02-2014 equivalent to Levoflocaxin …500mg 4. Obflox Tablet 030488 5-5-2003 Each tablet contains:- Valid until Levofloxacin Hemihydrate equivalent 29-09-2015 to Levoflocaxin …………. 250mg 5. Obpra Capsule 40mg 054166 19-2-2009 Each capsule contains:- Valid until Enteric coated pellets of Esomeprazole 18-2-2009 magnesium trihydrate eq. to
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Esomeprazole ………… 40mg 6. Vincam Capsule 20mg 029834 6-3-2003 Each capsule contains:- Valid until Piroxicam …………… 20mg 5-3-2013 7. Rubinol Tablet 025406 11-11-1999 Each tablet contains:- Valid until Flurbiprofen ……….. 100mg 10-11-2014 8. Azrocin Capsule 025403 11-11-1999 Each capsule contains:- Valid until Azithromycin dehydrate ……….. 10-11-2014 250mg 9. LevortizinTablet 054153 19-02-2009 Each tablet contains:- Valid until Leocetirizine dihydrate …….. 5mg 18-02-2014
10. Obpra Capsule 054165 19-02-2009 Each capsule contains:- Valid until Esomeprazole magnesium trihydrate 18-02-2014 enteric coated pellets equivalent to Esomeprazole ………………. 20mg
Decision: Registration Board decided as follows: i. Cancellation of above registrations from name of manufacturer (column II) except item at S.No.45 as it is case for change of contract manufacturer, which is deferred for processing in light of contract manufacturing policy. ii. Grant of above registrations in name of manufacturer (column III). Chairman, Registration Board will permit issuance of registration letter after evaluation /completion of Form 5A as per check list approved by Registration Board, renewal status and comments of Cost & Pricing Division about MRP of the drug.
The CEO of M/s. Obson Pharma Lahore has now submitted an application and stated that they had issued an NOC in 2013 in favor of M/s Scynchro Pharma for transfer of products. Since their agreement has been cancelled during this period therefore they withdraw NOC issued in favor M/s. Scynchro Pharma Lahore. He has requested to stop proceeding in this regard.
Meanwhile, M/s Synchro Pharmaceuticals, Lahore has submitted an application and stated that after cancellation of registration M/s. Obsons Pharmaceuticals are still manufacturing the same product while we are waiting for the issuance of transfer letter till to date.
Decsion: Registration Board decided to provide oppurtunity of personal hearing to both parties in next meeting. Till that time, no further action shall be taken in the subject case.
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Case No.15: Registration application of M/s. Medipak Lahore deferred in 255th meeting of Registration Board.
Registration Board in its 255th meeting discussed the following registration application of M/s Medipak Lahore and decided as under:- Medisol Solution Each liter contains:- Citric acid (Anhydrous)...... 7.30gm Sodium Citrate (Dihydrate)…22.00gm Dextrose (Monohydrate).24.50gm Water for Injection....Q.S (Anticoagulant Solution)
Decision:- Registration Board after deliberation decided to call firs representative for presentation of case before the board.
Registration Board in its 239th meeting deferred the above product of M/s. Medipak Ltd; Lahore for submission of new dossier, applicable fee for the product and expert opinion by Brig. Qaiser, AFIC. Initially the case was discussed in 141st meeting of the Drug Registration Board and was deferred for price comparison and subsequently again deferred in 213th meeting of DRB for getting clarification from the firm regarding the use of the formulation. The products was presented again in 222nd meeting and was deferred for review committee. It is further submitted that the above product is used as part of diagnostic kit used in diagnosis of disease like dengue fever. This product is not registered as drug in any reference Drug Regulatory Authority and also not registered locally. It would be more appropriate to refer the case to medical devices division. Decision: Registration Board received a request of the firm that they cannot appear before the board due to some other engagements therefore opputunity of personal hearing be provided in next meeting. Registration Board acceded to the request of the firm.
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Item No. III: Cases referred by Biological Drugs Division
Case No.01: Cases of Imported Human Biological Drugs from Reference Countries.
Registartion Baord approved registration of products subject to inspection of manufacturer abroad as per Import Policy for Finished Drugs, verification of storage facilities and fixation of MRP by Drug Pricing Committee.
Sr. Name of Brand Name & Type of Form Document Decision No Importer & Composition details (CoPP) Manufacturer Dy No & Date of application Me too status/New Fee submitted molecule
Pack size/ Demanded M.R.P 1. M/s Hakim sons ALBURX 20 Form-5A Swiss Medic Keeping in view (Impex) Pvt CoPP issued on approval status Limited, Hakim Each 50ml of vial Dy No. 384 DDC-BD 19-07-2012 of product by sons Building, 19 contains: dated 16-4-2014 Swiss Medic and West Warf Road, Human Albumin Marketing information of Karachi Pakistan (Human plasma 50000/- dated 08-11- Authorization legalized CoPP, protein with at least No. 5247604 2013 Registration CSL Bearing 96% Board approved AG, albumin)……10g 50000 dated 03-09- Me too the product as Wankdorfstrasse, 2015 3014 Bern Plasma substitute/ per Import Switzerland. plasma protein 50ml vial Policy for fraction Rs. 4900/- per vial Finished Drugs.
2. Eastern Trade INTRATECT Form-5A Legalized COPP Keeping in view Distribution 100g/L Solution for dated 4-3-2015 the approval Cooperative infusion Dy No. 2072 dated submitted. status of product Limited, Karachi 02-05-2014 by Regulatory 1 ml solution for Authority of infusion contains: 100000/- dated 02- Germany and Human Plasma Biotest Pharma 05-2014 information of GmBH proteins…….100mg legalized CoPP, Landsteinerstrabe Thereof Pack size; 50ml Registration 5 D-63303 immunoglobulin G Board approved Dreieich ≥ 96% The IgA content is the product as limited to ≤ per Import 1.8mg/L Policy for Immune sera finished drugs.
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3. M/s Merck (Pvt) LUVERIS 75 IU Form-5A Legalized EMA Keeping in view Ltd. Powder and solvent CoPP Certificate the approval D-7 Parveen for solution for Dy No. 231 R&I No. 06/11/48772 status of product Building, Injection. dated 24-4-12 dated 09-12- by EMA and Shaheed-e-Millat 2011 information of Road, Karachi, Each vial contains: 15000/- dated12-4- legalized CoPP, Pakistan Product License 2012+ Registration Lutropin alfa 35000/- dated 31-7- No. Board approved Manufacturer: (Recombinant 2013 EU/1/00/155/00 human luteinizing 1-006 Dated the product as Merck Serono hormone, Pack size: 1 vial with 29.11.2000 per Import S.A., Zone lyophilized)……..7 1 vial of WFI of as Policy for Industrielle de 5IU solvent for New molecule finished drugs. I’Ouriettaz, 1170 reconstitution Aubonne, Indication: As the firm has Switzerland. not submitted the Site responsible Luveris assocation demanded price for batch release with a Follicle of the product, in the EU: Merck Stimulating the reference will Serono S.p.A., Hormone (FSH) be sent to the Via Delle preparation is Pricing Division Magnolie 15, recommended for accordingly. Zona Industriale the stimulation of di Modugno, I- follicular 70026 Modugno development in (BA), Italy. adult women with severe luteinizing Hormone (LH) and (FSH) deficiency 4. Roche Pakistan GAZYVA Dy.No. 3097 (R&I) EMA CoPP No. Keeping in view Limited. Karachi 1000mg/40ml vial dated 30-12-15 09/14/80622 the approval dated 15-9-2014 status of product M.A. Holder: Each vial of 40ml Fee Rs. 50000/- dated by EMA and concentrate 29-12-2015 New molecule information of Roche contains: legalized CoPP, Obinutuzumab Registration Shelf life 36 months Registration Limited, 6 ……..1000mg Board approved Falcon way, Pack of 1’s Shire Park, Antineoplastic the product as Welwyn Garden agent, monoclonal per Import city, AL7 1TW, antibody Policy for UK finished drugs. Indication: Manufacturer: Gazyva in As the firm has Roche combination with not submitted the Diagnostics chlorambucil is demanded price GmbH, indicated for the of the product, Sandhofferstrasse treatment of adult the reference will 116, Mannheim, patients with be sent to the Germany. previously untreated
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CLL Pricing Division accordingly. 5. Sanofi-Aventis THYROGEN Application submit COPP No. 04- Deferred for Pakistan Limited, (Thyrotropin alfa, (R&I) Section dated 0013-2014-02- submission of Karachi thyrotropin alfa for 09-6-2014 PK Dated following: injection) 29/4/2014 copy a. Legalized CoPP/ Product License Fee Rs. 100000/- enclosed. GMP & Free holder (also Each vial contain Dated 09-6-2014 Sale Certifcate packager, labeler 1.1mg thyrotropin Product License of USFDA & batch release): alfa (Each 1 ml MRP to be submitted Holder No. 20- b. Orignal sole contains 0.9 mg/ml at time of price 898 dated 30- agency Genzyme of thyrotropin alfa fixation/ box of 11-1998 agreement. Corporation, when reconstituted 2vials. c. Stability data of 11Forbes Road, with 1.2 ml water GMP Certificate finished product. Northborough, for injection) No. UK GMP MA USA 24655 Insp Pharmacological GMP group: 22907/37128- Manufacturer: Pituitary and 0005 [H] dated Hypothalamic 31-12-2012. Hospira Inc. Hormones and 1776 North Analogues, Centennial Drive McPherson, KS Shelf life: three 67460USA years. 6. Sanofi-Aventis TOUJEO® Application submitted EMA COPP No. Keeping in view Pakistan Limited, SOLOSTAR (R&I) dated 28-9- 01/15/88142 the approval Karachi SOLUTION FOR 2015 Dated 19-5- status of product INJECTION IN 2015 copy by EMA and Manufacturer: PRE-FILLED PEN Fee Rs. 100000/- enclosed information of dated 23-9-2015 legalized CoPP, (Insulin glargine Product Sanofi-Aventis Registration Deutschland 300 U/mL, solution To be provided at Registration No. Board approved GmbH for injection) time of price fixation EU/1/00/133/03 Bruningstrabe 50 Pack sizes: 3&5 pre- 3-035 dated 24- the product as Industriepark Each ml contains filled pens of 1.5ml 4-2015 per Import Hochst 65926 300 units Insulin Policy for frankfurt am glargine. GMP Certificate Finished Drugs. Main, Germany NO. DE-HE-01- Pharmacological GMP-2015- As the firm has group: 0024 not submitted the Insulins and demanded price analogues for of the product, Injection. ATC the reference will Code: A10A E04 be sent to the Pricing Division accordingly. 7. Sanofi-Aventis DENGVAXIA, Dy No. 940 (R&I) COPP NO. Deferred for Pakistan Limited, powder and solvent dated 16-2-2016 2016010813450 evaluation of
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Karachi for suspension for 4 Dated 25-1- clinical data by Injection Fee Rs. 200000/- 2016 FDA following experts: Manufacturer (Dengue tetravalent dated 15-2-2016 for Republic of a. Maj. Gen. vaccine (live, powder and solvent Philippines. Muhammad Sanofi Pasteur attenuated). Aslam, Member Parc Industrial MRP 9500/- per dose Product License Registration Incarville, 27100 One dose (0.5 ml) No. BR-1128 Board. Val de Reuil contains: Pack size: Dated 22-12- b. Dr. Huma France. CYD dengue virus 2015 Qureshi, PMRC, serotype1,2,3,4…… 1. Powder (1 dose) in Islamabad. Final release site: …….each 4.5-6.0 vial + 0.5 ml of GMP Certificate c. Represenrative log10 CCID50/dose solvent in pre-filled No. of malaria Sanofi Pasteur syringe with 2 HPF/FR/222/20 control, WHO NVL 31-33 quai Pharmacological separate needles 15 Dated 05-10- Pakistan, Armand Barbes group: (pack size of 1). 2015 Islamabad. 69250 Neuville- ATC code: J07BX France sur-Saone J 2. Powder (1 dose) in France. (ANTINEFECTIVE vial + 0.5 ml of S FOR SYSTEMIC solvent in pre-filled USE) 07 syringe with 2 (VACCINES) B separate needles (VIRAL (pack size of 10). VACCINES) X (OTHER viral vaccines) 8. Sanofi-Aventis DENGVAXIATM Dy No. 941 (R&I) COPP NO. Deferred for Pakistan Limited, MD, powder and dated 16-2-2016 2016010813450 evaluation of Karachi solvent for 1 Dated 25-1- clinical data by suspension for Fee Rs. 200000/- 2016 FDA following experts: Manufacturer: Injection dated 15-2-2016 for Republic of a. Maj. Gen. (Dengue tetravalent powder and solvent Philippines. Muhammad Sanofi Pasteur vaccine (live, Aslam, Member NVL 31-33 quai attenuated). MRP 9500/- per dose Product License Registration Armand Barbes Pack size: No. BR-1129 Board. 69250 Neuville- One dose (0.5 ml) Dated 22-12- b. Dr. Huma sur-Saone contains: 1. Powder (5 doses) in 2015 qureshi, PMRC, France. CYD dengue virus vial + 2.5 ml of Islamabad. serotype1,2,3,4…… solvent in vial (pack GMP Certificate c. Represenrative …….each 4.5-6.0 size of 5). No. of malaria log10 CCID50/dose HPF/FR/222/20 control, WHO 15 Dated 05-10- Pakistan, Pharmacological 2015 Islamabad. group: NVL SITE, ATC code: J07BX France. J (ANTINEFECTIVE S FOR SYSTEMIC USE) (VACCINES) B (VIRAL
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VACCINES) X (OTHER viral vaccines)
Case No.02: Cases of WHO Prequalified Biological Drugs/ Vaccines
S.No. Name of Importer Brand Name & Dy No & Date of Document Decision & Manufacturer Composition application details (CoPP) Fee submitted Me too status Pack size 1. M/s Hoffman Hepatitis B Vaccine Dy. No 657- CoPP Provided Keeping in view Human Health (rDNA) Pediatric DDC-BD dated valid up to 17- the WHO Care, 32-Babar 11-08-2015 03-2016. Prequalification Baker Block, New Each dose of 0.5ml approval status, Garden Town contains: 100000/- Free sale Registrtion Board Lahore certificate approved the Purified Hepatitis B Single dose provided issued product as per M/s Serum surface ampoule of 0.5ml on 31-01-2016 Import Policy for Institute of India, antigen……10mcg Finished Drugs 212/ 2, Hadapsar, Adsorbed on and as per valid Pune India Aluminum legalized CoPP. Hydroxide….0.25mg The WHO to 0.40mg prequalification Thiomersal….0.005% approval status shall be confirmed from Produced by WHO database/ Hansenula website at the Polymorpha Yeast time of issuance of registration letter alongwith valid legalized CoPP 2. M/s Hoffman Hepatitis B Vaccine Dy. No 656- CoPP Provided Keeping in view Human Health (rDNA) Adult DDC-BD dated valid up to 17- the WHO Care, 32-Babar 11-08-2015 03-2016. Prequalification Baker Block, New Each dose of 1ml approval status, Garden Town contains: 100000/- Free sale Registrtion Board Lahore certificate approved the Purified Hepatitis B Single dose provided issued product as per M/s Serum surface ampoule of 1ml on 31-01-2016 Import Policy for Institute of India, antigen……20mcg Finished Drugs 212/ 2, Hadapsar, Adsorbed on and as per valid Pune India Aluminum legalized CoPP. Hydroxide….0.50mg The WHO to 0.80mg prequalification Thiomersal….0.005% approval status shall be confirmed from
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Produced by WHO database/ Hansenula website at the Polymorpha Yeast time of issuance of registration letter. 3. M/s Aster Life Eupenta Injection Dy. No 777 dated CoPP provided, Keeping in view Sciences, 32 Babar (one dose vial) 21-09-2015 issued on dated the WHO Block, New July, 22, 2015 Prequalification Garden Town Adsorbed Diphtheria- 100,000/- approval status, Lahore Tetanus toxoid- Free sale Registrtion Board Pertussis-Hepatitis B 0.5ml vial certificate approved the LG Life Sciences, (rDNA) and Rs. 1800/- provided issued product as per 151- Hemophilus Influenza on 22-07-15 Import Policy for Osongaengmyeong type b conjugate Finished Drugs -1-ro, Osong eup, vaccine and as per valid Heungdeopk-gu, legalized CoPP. Cheongju-si, Each 0.5ml vial The WHO Chungcheonbuk- contains: prequalification do, Republic of Diphtheria approval status Korea. toxoid…15Lf shall be Tetanus confirmed from toxoid….10Lf WHO database/ Detoxified purified website at the pertussis time of issuance antigen….≥4IU of registration Purified letter. HBsAg…..10µg Purified capsular polysaccharide (PRP) of Hib conjugated to tetanus toxoid (PRP- T)……..30˜50µg Aluminum Hydroxide Gel…..0.39mg Thimerosal….0.01w/ v%
For active primary immunization in against diphtheria, tetanus, hepatitis, pertussis and Hemophilus influenza type b in infants from 6 weeks of age 4. M/s Aster Life Eupenta Injection Dy. No 778 dated CoPP provided, Keeping in view Sciences, 32 Babar (Ten dose vial of 5ml) 21-09-2015 issued on dated the WHO Block, New July, 22, 2015 Prequalification Garden Town Adsorbed Diphtheria- 100,000/- approval status, Lahore Tetanus toxoid- Free sale Registrtion Board
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Pertussis-Hepatitis B 5ml vial certificate approved the LG Life Sciences, (rDNA) and Rs. 18000/- provided issued product as per 151- Hemophilus Influenza on 22-07-15 Import Policy for Osongaengmyeong type b conjugate Finished Drugs -1-ro, Osong eup, vaccine and as per valid Heungdeopk-gu, legalized CoPP. Cheongju-si, Each 0.5ml contains: The WHO Chungcheonbuk- Diphtheria prequalification do, Republic of toxoid…15Lf approval status Korea. Tetanus shall be toxoid….10Lf confirmed from Detoxified purified WHO database/ pertussis website at the antigen….≥4IU time of issuance Purified of registration HBsAg…..10µg letter. Purified capsular polysaccharide (PRP) of Hib conjugated to tetanus toxoid (PRP- T)……..30˜50µg Aluminum Hydroxide Gel…..0.39mg Thimerosal….0.01w/ v%
For active primary immunization in against diphtheria, tetanus, hepatitis, pertussis and hemophilus influenza type b in infants from 6 weeks of age 5. Hospital Services Easyfive-TT vaccine Dy No. 1041 Legalized Free Keeping in view & Sales 13-C R&I dated 24-3- Sale Certificate the WHO Annexe, Block 6, Each dose of 0.5ml of 2014 No. MB/07/632 Prequalification P.E.C.H.S, pentavalent vaccine: Dated 19-9- approval status, Shahrah-e-Faisal, 100000/- dated 2013 Registrtion Board Karach 75400. Diphtheria 24-3-2014 approved the toxoid….20Lf (30IU) Legalized product as per Tetanus CoPP Import Policy for Manufacturer of toxoid…….7.5Lf Pack Sizes No.MB/07/632/ Finished Drugs Drugs: (60IU) WHO GMP/08 and as per valid Inactivated w-B. (Pack of 250 Dated 21-9- legalized CoPP. PANACEA pertussis 12 OU doses – 25 Vials 2013 The WHO BIOTEC LTD., B- (4IU), recombinant x 10 Doses) prequalification 1 Extn./ A-27, Hepatitis B surface Product approval status Mohan Co- antigen……10mcg License No. shall be operative Industrial Hib (PRP- MB/07/632 confirmed from
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Estate, Mathura TT)….10mcg Dated 09-8- WHO database/ Road, New Delhi- Aluminium 2012. website at the 110044, India. phosphate time of issuance gel….0.25mg Legalized GMP of registration Manufacturing Thiomersal ….0.025 Certificate No. letter. Plant: mcg HFW-H Physiological (DRUGS) PANACEA saline….q.s. 173/07 Dated BIOTEC LTD. 01-3-2014 Malpur, baddi, Distt. Solan (H.P.) Indications: – 173 205, INDIA. Easyfive-TT vaccine is indicated for primary active immunization against Diphtheria, Tetanus, Pertossis, Hepatitis B and Haemophilus influenza type b in infants from 6 weeks onwards. 6. Amson Vaccines & JEEV® Dy No. 5432 COPP NO. Keeping in view Pharma (Pvt) Ltd. (R&I) DRAP 4325/M3A/201 the WHO Rawalpindi Japanese Encephalitis Dated 26-10- 4-6 Valid upto: Prequalification Pakistan Inactivated Vaccine 2015 16-1-2016 approval status, (Human) (Purified Registrtion Board Manufacturer Inactivated Vaccine – Fee Rs. 100000/- Product approved the Adsorbed). Dated 21-8-2015 License No. product as per M/s Biological E 01/RR/AP/200 Import Policy for Limited Each 0.5mL of Not provided/ 6/V/R, dated Finished Drugs Vaccine contains: Pack of 1’svial 05-11-2011 and as per valid 18/1&3, from DCA legalized CoPP. Azamabad, Purified Inactivated Andhra The WHO Hyderabad – 500 Japanese encephalitis Pradesh. prequalification 020, Andhra Virus Strain (SA 14- approval status Pradesh, INDIA 14-2)……6 µg shall be Aluminum as confirmed from Aluminum WHO database/ Hydroxide……..0.1% website at the w/v time of issuance Phosphate Buffer of registration Saline……q.s. letter.
Vaccine
Indications: For active immunization against Japanese Encephalitis
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in adults and children. 7. M/s Amson Euvichol (Oral Dy. No. 56 R&I Notarized GMP Keeping in view Vaccines & Cholera Vaccine) DRAP dated 28- Certificate the WHO Pharma (Pvt) Ltd. Liquid suspension 8-2015 receipt No. Prequalification Rawalpindi 2014015558 approval status, Pakistan Each glass vial Fee Rs. 100000/- dated 16-1- Registrtion Board contains 1.5 ml of dated 28-8-2015 2015 enclosed approved the Manufacturer inactivated (formalin product as per and/or heat) cells of Pack size: vial Legalized Import Policy for EuBiologics Co., Vibrio cholerae O1 1.5 ml COPP NO. Finished Drugs Ltd. Bomnal and O139 2015-A1-0249 and as per valid Achim 6F, 8 dated 25-2- legalized CoPP. Mabang-ro, Compositin: 2015 enclosed The WHO Seocho-gu, Seoul, prequalification Republic of Korea Active ingredients: Product approval status License No. 1 shall be confirmed from 1. V. cholerae O1 dated 28-1- WHO database/ Inaba Cairo 48 2015. website at the classical biotype, time of issuance Heat of registration inactivated.…..30 letter. 0 L.E.U. 2. V. cholerae O1 Inaba Phil 6973 E1 Tor biotype, Formalin inactivated…...60 0 L.E.U. 3. V. cholerae O1 Ogawa Cairo 50 classical biotype, Formalin inactivated…..300 L.E.U. 4. V. cholerae O1 Ogawa Cairo 50 classical biotype, Heat inactivated…..300 L.E.U. 5. V. cholerae O139 4260B, Formalin inactivated……..6 00 L.E.U.
Vaccine 8. M/s Amson ComBE Five Dy No. 1216 Copy of GMP Deferred for Vaccines & (Suspension for R&I DRAP Certificate NO. submission of Pharma (Pvt) Ltd. Injection). dated 25-2-2016 L.Dis. No. following Rawalpindi 3839/AB/(M3)/ documents :
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Pakistan Diphtheria, Tetanus, Fee Rs. 100000/- TS/2014 dated a. Sole agency Pertussis (Whole dated 25-2-2016 16-10-2014 agreement. Manufacturer cell), Hepatitis B b. Valid (rDNA) and Pack size: legalized M/s. Biiological E Haemophilus Type b 1ml – Two dose CoPP. Limited Conjugate Vaccine (Adsorbed) Shelf life: 24 18 / 1 7 3, months, when Azamabad, Each dose of 0.5 ml stored at 2-8oC. Hyderabad, India- contains: 500 020. Diphtheria Toxoid : 25 Lf (≥30IU) Tetanus toxooid : 5.5 Lf (≥60IU). B. Pertussis : 161 IOU Lf (≥ 4 IU) r-HBs Ag : 12.5 µg. Purified capsular polysaccharide of Hib covalently : 11 µg. Linked to 20 to 36.7 µg of tetanus toxoid.
A1+++ (as AIPO4) : ≤1.25 mg Preservative: Thiomersal BP : 0.01% w/v
Pharmacological group: Vaccine 9. M/s Amson ComBE Five Dy No. 708 R&I Copy of GMP Deferred for Vaccines & (Suspension for DRAP dated 03- Certificate NO. submission of Pharma (Pvt) Ltd. Injection). 2-2016. L.Dis. No. following Rawalpindi 3839/AB/(M3)/ documents: Pakistan Diphtheria, Tetanus, Fee Rs. 100000/- TS/2014 dated a. Sole agency Pertussis (Whole dated 03-2-2016 16-10-2014 agreement. Manufacturer cell), Hepatitis B b. Valid (rDNA) and Shelf life: 24 legalized M/s. Biiological E Haemophilus Type b months when CoPP. Limited Conjugate Vaccine stored at 2-8oC. (Adsorbed) 18 / 1 7 3, Pack Size: 2.5 Azamabad, Each dose of 0.5 ml ml Five dose) Hyderabad, India- contains: 500 020. Diphtheria Toxoid : 25 Lf (≥30IU) Tetanus toxooid : 5.5 Lf (≥60IU).
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B. Pertussis : 161 IOU Lf (≥ 4 IU) r-HBs Ag : 12.5 µg. Purified capsular polysaccharide of Hib covalently : 11 µg. Linked to 20 to 36.7 µg of tetanus toxoid.
A1+++ (as AIPO4) : ≤1.25 mg Preservative: Thiomersal BP : 0.01% w/v
Pharmacological group: Vaccine 10. M/s Amson ComBE Five Dy No. 163 R&I Copy of GMP Deferred for Vaccines & (Suspension for DRAP dated 10- Certificate NO. submission of Pharma (Pvt) Ltd. Injection). 3-2016 L.Dis. No. following Rawalpindi 3839/AB/(M3)/ documents: Pakistan Diphtheria, Tetanus, Fee Rs. 100000/- TS/2014 dated a. Sole agency Pertussis (Whole dated 10-3-2016 16-10-2014 agreement. Manufacturer cell), Hepatitis B b. Valid (rDNA) and Pack size: legalized M/s. Biiological E Haemophilus Type b 5ml – Ten dose CoPP. Limited Conjugate Vaccine (Adsorbed) Shelf life: 24 18 / 1 7 3, months, when Azamabad, Each dose of 0.5 ml stored at 2-8oC. Hyderabad, India- contains: 500 020. Diphtheria Toxoid : 25 Lf (≥30IU) Tetanus toxooid : 5.5 Lf (≥60IU). B. Pertussis : 161 IOU Lf (≥ 4 IU) r-HBs Ag : 12.5 µg. Purified capsular polysaccharide of Hib covalently : 11 µg. Linked to 20 to 36.7 µg of tetanus toxoid.
A1+++ (as AIPO4) : ≤1.25 mg Preservative: Thiomersal BP : 0.01% w/v
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Pharmacological group: Vaccine 11. Amson Vaccines & BEtt Dy No. 707 Deferred for Pharma (Pvt) Ltd. (Adsorbed Tetanus (R&I) DRAP submission of Rawalpindi Vaccine [Tetanus Dated 03-2-2016 following Pakistan Toxoid Vaccine] documents: Fee Rs. 100000/- a. Sole agency Manufacturer Each 0.5 mL of Dated 03-2-2016 agreement. vaccine contains: b. Legalized M/s Biological E Tetanus Ten dose vial of valid CoPP or Limited Toxoid……..≥40 IU 5ml Free Sale Adsorbed on Certficate and 18/1&3, Aluminium GMP Azamabad, Phosphate certificate. Hyderabad – (AIPO4)……. ≥1.5 INDIA, 500 020 mg Preservative: Thiomersal BP…….0.01% w/v
Pharmacolgical group:
Vaccine
Indications: For active immunization against tetanus in adults, children and infants. 12. Amson Vaccines & BEtt Dy No. Deferred for Pharma (Pvt) Ltd. (Adsorbed Tetanus 1215(R&I) submission of Rawalpindi Vaccine [Tetanus DRAP Dated 25- following Pakistan Toxoid Vaccine] 2-2016 documents: a. Sole agency Manufacturer Each 0.5 mL of Fee Rs. 100000/- agreement. vaccine contains: Dated 27-01- b. Legalized M/s Biological E Tetanus 2016 valid CoPP or Limited Toxoid……..≥40 IU Free Sale Adsorbed on Single dose vial Certficate a 18/1&3, Aluminium of 0.5ml and GMP Azamabad, Phosphate certificate. Hyderabad – (AIPO4)……. ≥1.5 INDIA, 500 020 mg Preservative: Thiomersal BP…….0.01% w/v
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Pharmacolgical group:
Vaccine
Indications: For active immunization against tetanus in adults, children and infants.
Case No.03: Cases of Local Manufacturing (Human Biological Drugs).
S.No. Name of Brand Name & Type of Form Document Decision Importer & Composition details Manufacturer Dy No & Date of (CoPP)/ application International availability in Fee Status/ reference agencies/ Pack size/ Price Me too status 1. Macter T-Mab Form-5 Me too Deferred for International (Trastuzumab) Dy No. 927 R&I evaluation of Ltd. 216, SITE, dated 17/4/2014 Brand name application by Karachi, Strength of ingredients Herceptin biological division Pakistan Local Contain 440mg/vial 20000/- dated 13- available in and rectification of Manufacturer) 1-2014 Pakistan following by the Antineoplastic firm: Monoclonal Demanded Price. a. Evidence of API from Antibodies As per PRC availability of Shanghai CP formulation in Guojian Manufacturer reference Pharmaceutical agencies. Co., Ltd b. Master No. 399 Libing formulation along Road with Zhangjiang manufacturing High-tech Park, method including Shanghai, in process China. controls. c. Complete finished product specifications along with method of testing. d. Confirmation of product specefic manufacturing facility.
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2. Macter Heberon 2b Dy No. 142 R&I Mee too Deferred for International (rh Interferon Alfa 2b dated 07-3-2014 evaluation of Ltd. 216, SITE, for injection) Brand name application by the Karachi, 20000/- dated 02- Intron A drug biological division Pakistan (Local Each vial contains: 9-2013 available in and rectification/ Manufacturer) Rh-Interferon alpha Pakistan clarification of 2b………..3MIU/0.3 Demanded Price: CoPP NO. following: License Holder ml As per PRC 20130015 a. Firm has provided Name & (Liquid solution for recommend by the CoPP, GMP & address. injection) WHO free sale enclosed certificates for the Harbin Indication: finished product. Pharmaceutical Product As decided in 246th Group Antiviral License No. meeting of RB, Bioengineering antiproliferative GYZZS109600 legalized GMP Co., Ltd immunomodulator 23 dated 1996 certificate of No.99 Zhuhai biological drug Road, Li Min GMP manufacturer Development Certificate No. abroad (who will Zone, Hulan CN20120006 provide Dist, Harbin, dated 19-1- concentrate / ready China 2012 valid until to fill bulk of 18-1-2017 biological drug to enclosed Pakistani manufacturers for further processing) Free Sale Certificate No. as an evidence that 20130017 the manufacturer is Dated 2013 an authorized enclosed from manufacturer of Food & Drug that particular Administration biological drug in Province of its country of Heilongjiang origin. th People’s b. As decided in 246 Republic of meeting studies China. conducted by manufacturer abroad (dully verified with statement for correctness / genuineness of data) regarding structural similarity of subject biological drug product (concentrate/ ready to fill bulk for further processing) Minutes for 257th Registration Board Meeting 299
with reference biological product (innovator) c. Master formulation along with manufacturing method including the in process controls. d. Complete finished product specifications along with method of testing. 3. Macter Heberon 2b Dy No. 147 R&I Mee too Deferred for International (rh Interferon Alfa 2b evaluation of Ltd. 216, SITE, for injection) 20000/- dated 02- Brand name application by the Karachi, 9-2013. Intron A drug biological division Pakistan (Local Each vial contains: available in and rectification/ Manufacturer) Rh-Interferon alpha Demanded Price: Pakistan clarification of 2b………..3MIU/ml As per PRC following: License Holder (Lyophilized Powder CoPP NO. a. Firm has provided Name & for injection 20130015 the CoPP, GMP address. 3MIU/Vial) recommend by & free sale WHO enclosed certificates for the Harbin Indication: finished product. Pharmaceutical Product As decided in th Group Antiviral License No. 246 meeting of Bioengineering antiproliferative GYZZS109600 RB, legalized Co., Ltd immunomodulator 23 dated 1996 GMP certificate No.99 Zhuhai of biological drug Road, Li Min GMP manufacturer Development Certificate No. abroad (who will Zone, Hulan CN20120006 provide Dist, Harbin, dated 19-1- concentrate / China 2012 valid until ready to fill bulk 18-1-2017 of biological drug enclosed to Pakistani manufacturers for further Free Sale Certificate processing) as an enclosed No. evidence that the 20130017 manufacturer is Dated 2013 an authorized from Food & manufacturer of Drug that particular Administration biological drug in Province of its country of origin. Heilongjiang th People’s b. As decided in 246
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Republic of meeting studies China. conducted by manufacturer abroad (dully verified with statement for correctness / genuineness of data) regarding structural similarity of subject biological drug product (concentrate/ ready to fill bulk for further processing) with reference biological product (innovator) c. Master formulation along with manufacturing method including the in process controls. d. Complete finished product specifications along with method of testing. 4. Hilton Pharma EPROL 75 mcg Form-5 Micera PFS of Deferred for (Pvt.) Ltd. 13, Injection PFS Roche Products evaluation of Sector 15, Dy No.195 R&I (MHRA) application by Korangi Each pre-filled 0.3ml dated 12-3-2014 biological division Industrial Area, syringes contains: Micera PFS of and submission of Karachi, methoxy polyethylene 20000/- dated 20- Roche Pakistan following documents: Pakistan. (Local glycol-epoetin 8-2013 Karachi a. Master Manufacturer) beta…….75 µg formulation needs Pack size. 1’s to be submitted Antianemic M.R.P. along batch size, preparations Rs 11531.00/- quantities used per batch and role Treatment of of inactives. symptomatic anaemia b. Specifications of associated with chronic API along with kidney disease (CKD) Certificate of in adult patients. analysis. c. Latest GMP Manufacturer inspection report. d. Evidence of
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approval of section. e. Data and documents as per decision of 246th meeting of Registration Board, 5. Hilton Pharma EPROL 100 mcg Form-5 Micera PFS of Deferred for (Pvt.) Ltd. 13, Injection PFS Roche Products evaluation of Sector 15, Dy No.214 R&I (MHRA) application by Korangi Each pre-filled 0.3ml dated 12-3-2014 biological division Industrial Area, syringes contains: Micera PFS of and submission of Karachi, methoxy polyethylene 20000/- dated 20- Roche Pakistan following documents: Pakistan. (Local glycol-epoetin 8-2013 Karachi a. Master Manufacturer) beta…….100 µg formulation needs Pack size. 1’s to be submitted Antianemic along batch size, preparations M.R.P. quantities used Rs 12800.00/- Pack per batch and role Treatment of of inactives. symptomatic anaemia b. Specifications of associated with chronic API along with kidney disease (CKD) Certificate of in adult patients. analysis. c. Latest GMP Manufacturer inspection report. d. Evidence of approval of section. e. Data and documents as per decision of 246th meeting of Registration Board, 6. Hilton Pharma EPROL 150 mcg Form-5 Micera PFS of Deferred for (Pvt.) Ltd. 13, Injection PFS Roche Products evaluation of Sector 15, Dy No.213 R&I (MHRA) application by Korangi Each pre-filled 0.3ml dated 12-3-2014 biological division Industrial Area, syringes contains: Micera PFS of and submission of Karachi, methoxy polyethylene 20000/- dated 20- Roche Pakistan following documents: Pakistan. (Local glycol-epoetin 8-2013 Karachi a. Master Manufacturer) beta…….150 µg formulation needs Pack size. 1’s/ to be submitted Antianemic Rs 19219.00/- along batch size, preparations quantities used per batch and role Treatment of of inactives. symptomatic anaemia b. Specifications of
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associated with chronic API along with kidney disease (CKD) Certificate of in adult patients. analysis. c. Latest GMP Manufacturer inspection report. d. Evidence of approval of section. e. Data and documents as per decision of 246th meeting of Registration Board, 7. Hilton Pharma EPROL 200 mcg Form-5 Micera PFS of Deferred for (Pvt.) Ltd. 13, Injection PFS Roche Products evaluation of Sector 15, Dy No.212 R&I (MHRA) application by Korangi Each pre-filled 0.3ml dated 12-3-2014 biological division Industrial Area, syringes contains: Micera PFS of and submission of Karachi, methoxy polyethylene 20000/- dated 20- Roche Pakistan following documents: Pakistan. (Local glycol-epoetin 8-2013 Karachi a. Master Manufacturer) beta…….200 µg formulation needs Pack size. 1’s/ Rs to be submitted Antianemic 32032.00/- along batch size, preparations quantities used per batch and role Treatment of of inactives. symptomatic anaemia b. Specifications of associated with chronic API along with kidney disease (CKD) Certificate of in adult patients. analysis. c. Latest GMP Manufacturer inspection report. d. Evidence of approval of section. e. Data and documents as per decision of 246th meeting of Registration Board, 8. Hilton Pharma EPROL 250 mcg Dy No.211 R&I Micera PFS of Deferred for (Pvt.) Ltd. 13, Injection PFS dated 12-3-2014 Roche Products evaluation of Sector 15, (MHRA) application by Korangi Each pre-filled 0.3ml 20000/- dated 20- biological division Industrial Area, syringes contains: 8-2013 Micera PFS of and submission of Karachi, methoxy polyethylene Roche Pakistan following documents: Pakistan. (Local glycol-epoetin Pack size. 1’s/ Rs Karachi a. Master Manufacturer) beta…….250 µg 37727.00/- formulation needs
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to be submitted Antianemic along batch size, preparations quantities used per batch and role Treatment of of inactives. symptomatic anaemia b. Specifications of associated with chronic API along with kidney disease (CKD) Certificate of in adult patients. analysis. c. Latest GMP Manufacturer inspection report. d. Evidence of approval of section. e. Data and documents as per decision of 246th meeting of Registration Board, 9. Getz Pharma Atosib Solution for Form 5-D Atosiban SUN Deferred for (Pvt) Limited Injection 7.5mg/ml solution for evaluation of 29-30/27, Dy No. 11 DDC injection of application by Korangi Each vial of 0.9ml (BD) dated 14-3- SUN biological division Industrial Area, solution contains: 2014 pharmaceutical and rectification/ Karachi. (Local Atosiban…6.75mg (as U.K submission of Manufacturer) acetate) Rs.50000/- dated (MHRA following: 24-10-2013 Approved) a. Incomplete assay (Strength of active method has been ingredient(s) Unit pack Size: provided by the 6.75mg/0.9mL) Box of 1’s firm under Proposed/Demande finished product Oxytocin antagonist d MRP: Rs. 2000/- specification b. Evidence of Manufacturer approval of sections is required. c. Latest GMP Inspection report is required. d. Stability data is not submitted by the firm.
10. Getz Pharma Atosib Concentrate for Dy No. 22 DDC Atosiban SUN Deferred for (Pvt) Limited Solution for Infusion (BD) dated 14-3- solution for evaluation of 29-30/27, 7.5mg/ml 2014 injection of application by Korangi SUN biological division Industrial Area, Each vial of 5ml Form 5-D pharmaceutical and rectification/
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Karachi. (Local solution contains: U.K submission of Manufacturer) Atosiban…37.5mg (as Rs.50000/- dated (MHRA following: acetate) 24-10-2013 Approved) a. Incomplete assay method has been (Strength of active provided by the ingredient(s) Pack size & MRP: firm under 37.5mg/5mL) finished product Unit pack Size: specification Box of 1’s x 1mL b. Evidence of Oxytocin antagonist Proposed/Demande approval of d MRP: Rs. 8500/- section is Manufacturer required. c. Latest GMP Inspection report is required. d. Stability data is not submitted by the firm.
11. Getz Pharma Cartoc Solution For Dy No. 12 DDC Pabel 100 mcg Deferred for (Pvt) Limited Injection 100mcg/ml (BD) dated 14-3- solution for evaluation of 29-30/27, 2014 injection of application by Korangi Each mL contains: Ferring Pharma biological division Industrial Area, Carbetocin….100mcg/ Fee Rs.50000/- (MHRA) and submission of Karachi. (Local ml following: Manufacturer) Pack size & MRP: a. Evidence of Oxytocin analogue approval of Unit pack Size: sections is Manufacturer Box of 10’s x 1ml required. vial b. Latest GMP Proposed/Demande Inspection report d MRP: Rs. 500/- is required. c. Stability data is Unit pack Size: not submitted by Box of 5’s x 1ml the firm. vial d. Product is Proposed/Demande approved in d MRP: Rs. 250/- reference agencies in ampoule, however it is applied in vial, justification is required. 12. M/s BF Bio ERITROGEN 2000 IU Form-5 Eprex PFS Deferred for Sciences Ltd. (MHRA) evaluation of Lahore Each prefilled syringe Dy. No 134 dated application by contains: 09-05-2014 Eprex PFS of biological divison Janssen Cilag and submission of Erythropoietin…..2000 20000/- dated 08- Pakistan following:
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IU 05-2014 a. Internationally product is in Antianemic As per SRO/ Pack 0.5ml PFS of 1’s however in instant Manufacturer case it is 1ml vial. b. Me to status provided by the firm needs confirmation. c. Master formulation along with batch size needs to be submitted. d. Specification of API along with COA and complete methods of testing with reference is required. e. Under finished product specifications, identification test are required. Furthermore methods of testing for immune characterization and assay needs to be submitted along with the evidence of availability necessary testing facilities f. Latest GMP inspection report is required as submitted report is of 2013. g. Evidence of approval of section needs to be submitted. h. Stability data submitted is of vials however the applied product is
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PFS. This requires clarification. i. As per decision of 246th meeting of registration Board, requirements needs to be full filled by the applicant 13. M/s BF Bio ERITROGEN 4000 IU Form-5 Eprex PFS Deferred for Sciences Ltd . (MHRA) evaluation of Lahore Each 1ml prefilled Dy. No 135 dated application by syringe contains: 09-05-2014 Eprex PFS of biological divison Janssen Cilag and submission of Erythropoietin….4000 20000/- dated 08- Pakistan following: IU 05-2014 a. Internationally product is in Antianemic As per SRO/ Pack 0.5ml PFS of 1’s however in instant Manufacturer case it is 1ml vial. b. Me to status provided by the firm needs confirmation. c. Master formulation along with batch size needs to be submitted. d. Specification of API along with COA and complete methods of testing with reference is required. e. Under finished product specifications, identification test are required. Furthermore methods of testing for immune characterization and assay needs to be submitted along with the evidence of
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availability necessary testing facilities f. Latest GMP inspection report is required as submitted report is of 2013. g. Evidence of approval of section needs to be submitted. h. Stability data submitted is of vials however the applied product is PFS. This requires clarification. i. As per decision of 246th meeting of registration Board, requirements needs to be full filled by the applicant 14. M/s BF Bio ERITROGEN 10000 Form-5 Eprex PFS Deferred for Sciences Ltd . IU (MHRA) evaluation of Lahore Dy. No 136 dated application by Each 1ml prefilled 09-05-2014 Eprex PFS of biological divison syringe contains: Janssen Cilag and submission of 20000/- dated 08- Pakistan following: Erythropoietin….1000 05-2014 a. Internationally 0 IU product is in As per SRO/ Pack 0.5ml PFS Antianemic of 1’s however in instant case it is 1ml vial. Manufacturer b. Me to status provided by the firm needs confirmation. c. Master formulation along with batch size needs to be submitted. d. Specification of API along with COA and complete methods
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of testing with reference is required. e. Under finished product specifications, identification test are required. Furthermore methods of testing for immune characterization and assay needs to be submitted along with the evidence of availability necessary testing facilities f. Latest GMP inspection report is required as submitted report is of 2013. g. Evidence of approval of section needs to be submitted. h. Stability data submitted is of vials however the applied product is PFS. This requires clarification. i. As per decision of 246th meeting of registration Board, requirements needs to be full filled by the applicant 15. M/s BF Bio Peg-INF PFS Form-5 Pegasys Roche Deferred for Sciences Ltd. (EMA) evaluation of Lahore Each 0.5ml prefilled Dy. No 136 dated application by syringe contains: 09-05-2014 Pegasys Roche biological divison Pakistan and submission of Peg- Interferon alpha 20000/- dated 08- Karachi following: 2a…….180mcg 05-2014 a. Internationally product is in
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Immunostimulating As per SRO/ Pack 0.5ml PFS agent of 1’s however in instant case it is 1ml vial. Manufacturer b. Me to status provided by the firm needs confirmation. c. Master formulation along with batch size needs to be submitted. d. Specification of API along with COA and complete methods of testing with reference is required. e. Under finished product specifications, identification test are required. Furthermore methods of testing for immune characterization and assay needs to be submitted along with the evidence of availability necessary testing facilities f. Latest GMP inspection report is required as submitted report is of 2013. g. Evidence of approval of section needs to be submitted. h. Stability data submitted is of vials however the applied product is PFS. This requires clarification.
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i. As per decision of 246th meeting of registration Board, requirements needs to be full filled by the applicant 16. M/s Macter EPOCAN Injection Form-5 CoPP of Deferred for International finished evaluation of (Pvt) Limited Each vial contains: Dy. No 1626 dated product dated application by Karachi 15-04-2014 1-8-2013 biological division Epoetin alpha submitted and submission of …….2000IU/ml 20000 following: FSC of finished a. Specifications of Antianemic As per PRC product dated Bulk material 26.8.2013 along with COA Manufacture provided are required. b. Complete finished (Ready to fill bulk for Me too product filling and packing) specifications needs to be submitted by the firm. c. Latest GMP inspection report is required. d. As per decision of 246th meeting of registration Board, requirements needs to be full filled by the applicant 17. M/s Macter EPOCAN Injection Form-5 CoPP of Deferred for International finished evaluation of (Pvt) Limited Each vial contains: Dy. No 1625 dated product dated application by Karachi 15-04-2014 1-8-2013 biological division Epoetin alpha submitted and submission of …….4000IU/ml 20000 following: FSC of finished a. Specifications of Antianemic As per PRC product dated Bulk material 26.8.2013 along with COA Manufacture provided are required. b. Complete finished (Ready to fill bulk for product filling and packing) Me too specifications needs to be submitted by the
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firm. c. Latest GMP inspection report is required. d. As per decision of 246th meeting of registration Board, requirements needs to be full filled by the applicant 18. M/s Macter EPOCAN Injection Form-5 CoPP of Deferred for International finished evaluation of (Pvt) Limited Each vial contains: Dy. No 1627 dated product dated application by Karachi 15-04-2014 1-8-2013 biological division Epoetin alpha submitted and submission of …….10000IU/ml 20000 following: FSC of finished a. Specifications of Antianemic As per PRC product dated Bulk material 26.8.2013 along with COA Manufacture provided are required. b. Complete finished (Ready to fill bulk for Me too product filling and packing) specifications needs to be submitted by the firm. c. Latest GMP inspection report is required. d. As per decision of 246th meeting of registration Board, requirements needs to be full filled by the applicant 19. Macter Biovac HB Out Dy No. 184 Mee too Deferred for International (Recombinant dated 10.3.2014 confirmation of Ltd. 216, SITE, Hepatitis B Vaccine) Brand name availability of Karachi, 20 µg/ml 20000/- dated 21- Energix-B manufacturing facilty Pakistan (Local 8-2013 available for vaccines. Manufacturer) manufacturer Price. As per PRC by GSK BulK Pakistan materialsource: LG Life Legalized Sciences Korea. CoPP No. 2-
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13-A1-1023 Republic of Korea
Product License No. 213 dated 29- 12-1994
Legalized Free sale certificate No. 2013-A1- 1022 dated 08- 5-2013
Legalized GMP Dated 15-3- 2013 enclosed. 20. Macter Biovac HB Dy No.40 DDC Legalized Deferred for International (Recombinant (BD) Dated 17-3- CoPP No. confirmation of Ltd. 216, SITE, Hepatitis B Vaccine) 2014 2015-A1-0917 availability of Karachi, 10 µg/0.5ml Dated 16-7- manufacturing facilty Pakistan (Local Fee Rs. 20000/- 2015 for vaccines. Manufacturer) Dated 21-8-2013 Product Price: As per PRC License No. 213 dated 29- 12-1994
Legalized GMP No. 2015-F1- 0102 dated 09- 4-2015
Case No.04: Cases of Imported Human Biological Drugs from Non Reference Agencies
Registartion Baord approved Registration of products subject to inspection of manufacturer abroad as per Import Policy for Finished Drugs, verification of storage facilities and fixation of MRP by Drug Pricing Committee.
S.No. Name of Brand Name & Dy No & Date of Document Decision Importer & Composition application/ details
Manufacturer Fee Status/ (CoPP)/ Pack size/ Price International availability/ Me too status 1. M/s Allmed ENOXA 2000 IU Dy No. 1140 R&I Market Deferred for expert Laboratories, A- anti Xa 20mg dated 23-5-2014 authorization opinion of
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21/3 KDA Solution Injectable 2 no. 9233494 following: Scheme No. 1 Syringes / 0.2 ml 15000 dated 02-1- until valid 05- a. Dr. Abid Azhar, Ext Karachi 2012 2017 A.Q.Khan Pakistan One prefilled syringe 85000/- dated 11- Sole agency Institute of of 0.2 ml contains: 10-2012 agreement Biotechnology, Les Enoxaparin Sodium dated 23-11- University of Laboratories ……20mg As per PRC/ Pack of 2015 Karachi. Medis Route De 2’s syringes b. Dr. Zeeshan Nabeul Km Antithrombotic Clexane Danish, 78000 Nabeul prefilled University of the Tunise syringes Punjab. (MHRA) c. Prof. Dr Ghias Butt, PIMS Clexane PFS of Islamabad.
Sanofi Karachi
2. M/s Allmed ENOXA 4000 IU Dy No. nil R&I Market Deferred for expert Laboratories, A- anti Xa 40mg dated 26/5/2014 authorization opinion of 21/3 KDA Solution Injectable 2 no. 9233494 following: Scheme No. 1 Syringes / 0.4 ml 15000 dated 02-1- until valid 05- a. Dr. Abid Azhar, Ext Karachi 2012 2017 A.Q.Khan Pakistan One prefilled syringe 85000/- dated 11- Sole agency Institute of of 0.4 ml contains: 10-2012 agreement Biotechnology, Les Enoxaparin Sodium dated 23-11- University of Laboratories ……40mg As per PRC/ Pack of 2015 Karachi. Medis Route De 2’s syringes b. Dr. Zeeshan Nabeul Km Antithrombotic Clexane Danish, 78000 Nabeul prefilled University of the Tunise syringes Punjab. (MHRA) c. Prof. Dr Ghias Butt, PIMS Clexane PFS of Islamabad. Sanofi Karachi
3. M/s Allmed ENOXA 6000 IU Dy No. 1139 R&I Market Deferred for expert Laboratories, A- anti Xa 60mg dated 23/5/2014 authorization opinion of 21/3 KDA Solution Injectable 2 no. 9233494 following: Scheme No. 1 Syringes / 0.6 ml 15000 dated 02-1- until valid 05- a. Dr. Abid Azhar, Ext Karachi 2012 2017 A.Q.Khan Pakistan One prefilled syringe 85000/- dated 11- Sole agency Institute of of 0.6 ml contains: 10-2012 agreement Biotechnology, Les Enoxaparin Sodium dated 23-11- University of Laboratories ……60mg As per PRC/ Pack of 2015 Karachi. Medis Route De 2’s syringes b. Dr. Zeeshan Nabeul Km Antithrombotic Clexane Danish, 78000 Nabeul prefilled University of the Tunise syringes Punjab. (MHRA) c. Prof. Dr Ghias Butt, PIMS
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Clexane PFS of Islamabad. Sanofi Karachi
4. M/s Allmed ENOXA 8000 IU Dy No. 1141 R&I Market Deferred for expert Laboratories, A- anti Xa 80mg dated 23/5/2014 authorization opinion of 21/3 KDA Solution Injectable 2 no. 9233494 following: Scheme No. 1 Syringes / 0.8 ml 15000 dated 22-11- until valid 05- a. Dr. Abid Azhar, Ext Karachi 2011 2017 A.Q.Khan Pakistan One prefilled syringe 85000 dated 11-11- Sole agency Institute of of 0.8 ml contains: 2011 agreement Biotechnology, Les Enoxaparin Sodium dated 23-11- University of Laboratories ……80mg As per PRC/ Pack of 2015 Karachi. Medis Route De 2’s syringes b. Dr. Zeeshan Nabeul Km Antithrombotic Clexane Danish, 78000 Nabeul prefilled University of the Tunise syringes Punjab. (MHRA) c. Prof. Dr Ghias Butt, PIMS Clexane PFS of Islamabad. Sanofi Karachi 5. Sncura EMGRAST-M Dy No. 5710 R&I Legalized Deferred for Enterprizes (500µg) dated 06-9-2013 COPP/CERT/P clarification for sole Pakistan Pvt D/6130/2013/1 agency from M/s Ltd. 163-A, Each vial of Rs.50000/- dated 06- 1/2143/8861 Gennova Bank Road, contains: 9-2013 Dated Biopharmaceuticals Saddar, Recombinant Human 30.12.2014 Limited Pune, Rawalpindi, Granulocyte Unit price enclosed. Maharashtra India, Pakistan Macrophage Colony Rs.7413.00/- as the Letter of stimulating Factor (r- Legalized GMP Authorization is by Manufacturer. hu- Certificate no. M/s Emcure GMCSF)……..500 NEW-WHO- Pharmaceuticals, Gennova mcg. GMP- Mena-LLC Dubai, Biopharmaceuti CERT/PD/406 which states that cals Limited As lyophilized 8/2012/11/1133 Gennova Plot No. P1, powder to be Dated 31-12- Biopharmaceuticals ITBT Park, reconstituted with 1 2012 enclosed. Limited is its group Phase II MIDC, ml of sterile water company, having its Hinjwadi, Pune for Injection. Legalized Free registered office at 411057, sale Certificate Emcure House, T- Maharashtra No. 184, MIDC, Bhosari India. Colony stimulating Drugs/Mfg/FS Pune India. factor C/ 226 -13/Z- IV Dated 14-6- 2013 enclosed. 6. Sncura Xgrast 300mcg vial Dy No. 5712 R&I Legalized Deferred for Enterprizes dated 06-9-2013 COPP/CERT/P clarification for sole Pakistan Pvt Each vial contains: D/6130/2013/1 agency from M/s Ltd. 163-A, Filgrastim (solution Rs.50000/- dated 06- 1/2143/8857 Gennova Bank Road, for 9-2013 Dated Biopharmaceuticals
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Saddar, injection)…..300mcg 30.12.2014 Limited Pune, Rawalpindi, Unit price enclosed. Maharashtra India, Pakistan Cytokine Rs.6607.65/- Pack as the Letter of of 1’s Authorization is by Manufacturer. Legalized GMP M/s Emcure recommended Pharmaceuticals, Gennova by WHO No. Mena-LLC Dubai, which states that Biopharmaceuti NEW-WHO- Gennova cals Limited GMP- Plot No. P1, CERT/PD/406 Biopharmaceuticals
ITBT Park, 8/2012/11/1133 Limited is its group Phase II MIDC, Dated 31-12- company, having its Hinjwadi, Pune 2012 enclosed. registered office at 411057, Emcure House, T- Maharashtra Legalized Free 184, MIDC, Bhosari India. sale Certificate Pune India. No. Drugs/Mfg/FS C/ 229 -13/Z- IV Dated 14-6- 2013 enclosed. 7. Sncura VINTORTM 20000 Out Dy No. 591 Legalized Deferred for Enterprizes Erythropoietin dated 26.3.2014 COPP/CERT/P clarification for sole Pakistan Pvt Injection BP 20000 D/6130/2013/1 agency from M/s Ltd. 163-A, IU/ml Rs.50000/- dated 06- 1/2143/8854 Gennova Bank Road, 9-2013 + Dated Biopharmaceuticals Saddar, Each 1 ml Single 50000/- dated 06-9- 30.12.2014 Limited Pune, Rawalpindi, dose Pre-Filled 2013 enclosed. Maharashtra India, Pakistan Syringe contains as the Letter of 20000 Units of Unit price Legalized GMP Authorization is by Manufacturer. Erythropoietin (as Rs. 13107.15/- Recommended M/s Emcure Erythropoietin by WHO No. Pharmaceuticals, Gennova Concentrated NEW-WHO- Mena-LLC Dubai, Biopharmaceuti Solution Ph. Eur.) GMP- which states that cals Limited This formulation CERT/PD/406 Gennova Plot No. P1, contains no 8/2012/11/1133 Biopharmaceuticals ITBT Park, preservative. Dated 31-12- Limited is its group Phase II MIDC, 2012 enclosed. company, having its Hinjwadi, Pune Blood Forming agent registered office at 411057, (Antianemic Legalized Free Emcure House, T- Maharashtra preparation). sale Certificate 184, MIDC, Bhosari India. No. Pune India. Drugs/Mfg/FS C/ 224 -13/Z- IV Dated 14-6- 2013 enclosed.
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8. Sncura VINTORTM 4000 Out Dy No. 588 Legalized Deferred for Enterprizes Erythropoietin dated 26.3.2014 COPP/CERT/P clarification for sole Pakistan Pvt Injection BP 4000 D/4455/2013/1 agency from M/s Ltd. 163-A, IU/ml Rs.50000/- dated 04- 1/1363. Gennova Bank Road, 12-2013 + Dated Biopharmaceuticals Saddar, Each 1 ml single Rs.50000/- dated 30- 30.12.2014 Limited Pune, Rawalpindi, dose Pre-Filled 10-203 enclosed. Maharashtra India, Pakistan Syrige contains 4000 as the Letter of Units of Unit price Legalized GMP Authorization is by Manufacturer. Erythropoietin (as Rs. 3147.90/- Recommended M/s Emcure Erythropoietin by WHO No. Pharmaceuticals, Gennova concentrated NEW-WHO- Mena-LLC Dubai, Biopharmaceuti Solution Ph. Eur.) GMP- which states that cals Limited This formulation CERT/PD/406 Gennova Plot No. P1, contains no 8/2012/11/1133 Biopharmaceuticals ITBT Park, preservative. Dated 31-12- Limited is its group Phase II MIDC, 2012 enclosed. company, having its Hinjwadi, Pune Indication: registered office at 411057, Legalized Free Emcure House, T- Maharashtra Treatment of anemia sale Certificate 184, MIDC, Bhosari India. of chronic renal No. Pune India. patients. Drugs/Mfg/FS C/ 221 -13/Z- Treatment of anemia IV in Zidovudine- Dated 14-6- treated HIV-infected 2013 enclosed. patients.
Treatment of anemia in cancerpatients on chemotherapy.
Reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery.
9. Sncura VINTORTM 2000 Out Dy No. 587 Legalized Deferred for Enterprizes Erythropoietin dated 26.3.2014 COPP/CERT/P clarification for sole Pakistan Pvt Injection BP 2000 D/4455/2013/1 agency from M/s Ltd. 163-A, IU/ml Rs.50000/- dated 04- 1/1363. Gennova Bank Road, 12-2013 + Dated Biopharmaceuticals Saddar, Each 1 ml single Rs.50000/- dated 06- 30.12.2014 Limited Pune, Rawalpindi, dose Pre-Filled 9-203 enclosed. Maharashtra India, Pakistan Syrige contains 2000 as the Letter of Units of Unit price Legalized GMP Authorization is by
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Manufacturer. Erythropoietin (as Rs. 1827.00/- Recommended M/s Emcure Erythropoietin by WHO No. Pharmaceuticals, Gennova concentrated NEW-WHO- Mena-LLC Dubai, Biopharmaceuti Solution Ph. Eur.) GMP- which states that cals Limited This formulation CERT/PD/406 Gennova Plot No. P1, contains no 8/2012/11/1133 Biopharmaceuticals ITBT Park, preservative. Dated 31-12- Limited is its group Phase II MIDC, 2012 enclosed. company, having its Hinjwadi, Pune Indication: registered office at 411057, Legalized Free Emcure House, T- Maharashtra Treatment of anemia sale Certificate 184, MIDC, Bhosari India. of chronic renal No. Pune India. patients. Drugs/Mfg/FS C/ 220 -13/Z- Treatment of anemia IV in Zidovudine- Dated 14-6- treated HIV-infected 2013 enclosed. patients.
Treatment of anemia in cancerpatients on chemotherapy.
Reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery.
10. Sncura VINTORTM 6000 Out Dy No. 589 Legalized Deferred for Enterprizes Erythropoietin dated 26.3.2014 COPP/CERT/P clarification for sole Pakistan Pvt Injection BP 6000 D/4455/2013/1 agency from M/s Ltd. 163-A, IU/ml Rs.50000/- dated 04- 1/1363. Gennova Bank Road, 12-2013 + Dated Biopharmaceuticals Saddar, Each 1 ml single Rs.50000/- dated 06- 30.12.2014 Limited Pune, Rawalpindi, dose Pre-Filled 9-203 enclosed. Maharashtra India, Pakistan Syrige contains 6000 as the Letter of Units of Unit price Legalized GMP Authorization is by Manufacturer. Erythropoietin (as Rs. 4898.25/- Recommended M/s Emcure Erythropoietin by WHO No. Pharmaceuticals, Gennova concentrated NEW-WHO- Mena-LLC Dubai, Biopharmaceuti Solution Ph. Eur.) GMP- which states that cals Limited This formulation CERT/PD/406 Gennova Plot No. P1, contains no 8/2012/11/1133 Biopharmaceuticals ITBT Park, preservative. Dated 31-12- Limited is its group Phase II MIDC, 2012 enclosed. company, having its Hinjwadi, Pune Indication: registered office at
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411057, Legalized Free Emcure House, T- Maharashtra Treatment of anemia sale Certificate 184, MIDC, Bhosari India. of chronic renal No. Pune India. patients. Drugs/Mfg/FS C/ 222 -13/Z- Treatment of anemia IV in Zidovudine- Dated 14-6- treated HIV-infected 2013 enclosed. patients.
Treatment of anemia in cancerpatients on chemotherapy.
Reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery.
11. Matrix Pharma Gonadopin NF Out Dy No 1389 Legalized Deferred for expert Pvt.Ltd. Injenctin Prefilled Dated 2311-2010 CoPP No. opinion by Karachi. Syringe 75 2013-A1-1372 following: IU/0.25ML (For Fee Rs. 50000/- dated 02-7- a. Brig (R), Manufacturer Human) dated 09-12-2013 + 2013 enclosed Muzamil Hussain (Recombinant 50000/- dated 17- Najmi, Member Dong-A ST Co. Human follicle 12-2013 Product Registration Ltd, 64, Stimulating License No. Board. Cheonho-daero, Hormone) MRP Rs. 3,675.00/- 983 dated 15-1- b. Brig. Amir dongdaemun- for Single Prefilled 2010 Ikram, AFIP gu, seoul, Pharmacological Syringe Rawalpindi. Korea. group: Legalized GMP c. Dr. Masud-ur- Gonadotropin No. 2013-EI- Rehman, DDG, 0077 dated 27- DRAP, Indication: 6-2013 Islamabad. For the treatment of enclosed infertility 12. Matrix Pharma Gonadopin NF Out Dy No. 1390 Legalized Deferred for expert Pvt.Ltd. Injection Prefilled dated 23-11-2015 CoPP No. opinion by Karachi. Syringe 2013-A1-1372 following: 150IU/0.5ML (For Fee Rs.50000/- dated 02-7- a. Brig (R), Manufacturer Human) dated 09-12-2013 + 2013 enclosed Muzamil Hussain (Recombinant 50000/- dated 17- Najmi, Member Dong-A ST Co. Human follicle 12-2013 Product Registration Ltd, 64, Stimulating License No. Board. Cheonho-daero, Hormone) Pack size: 5 and 10 983 dated 15-1- b. Brig. Amir dongdaemun- Prefilled Syringe 2010 Ikram, AFIP gu, seoul, Pharmacological Rawalpindi.
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Korea. group: Legalized GMP c. Dr. Masud-ur- Gonadotropin MRP Rs. 6650.00/- No. 2013-EI- Rehman, DDG, for single prefilled 0077 dated 27- DRAP, Indication: syringe 6-2013 Islamabad. For the treatment of enclosed infertility 13. Matrix Pharma Gonadopin NF Out Dy. No. 1391 Legalized Deferred for expert Pvt.Ltd. Injenctin Prefilled dated 23-11-2015 CoPP No. opinion by Karachi. Syringe 225 2013-A1-1372 following: IU/0.75ML (For Fee Rs. 50000/- dated 02-7- a. Brig (R), Manufacturer Human) dated 09-12-2013 + 2013 enclosed Muzamil Hussain (Recombinant 50000/- dated 17- Najmi, Member Dong-A ST Co. Human follicle 12-2013 Product Registration Ltd, 64, Stimulating License No. Board. Cheonho-daero, Hormone) Pack size: 5 and 10 983 dated 15-1- b. Brig. Amir dongdaemun- Prefilled Syringe 2010 Ikram, AFIP gu, seoul, Pharmacological Rawalpindi. Korea. group: MRP Legalized GMP c. Dr. Masud-ur- Gonadotropin Rs. 9975.00/- for No. 2013-EI- Rehman, DDG, single prefilled 0077 dated 27- DRAP, Indication: syringe 6-2013 Islamabad. For the treatment of enclosed infertility 14. Matrix Pharma Gonadopin NF Out Dy. No. 1392 Legalized Deferred for expert Pvt.Ltd. Injenctin Prefilled dated 23-11-2015 CoPP No. opinion by Karachi. Syringe 300 2013-A1-1372 following: IU/1.5ML (For Fee Rs. 50000/- dated 02-7- a. Brig (R), Manufacturer Human) dated 09-12-2013 + 2013 enclosed Muzamil Hussain (Recombinant 50000/- dated 17- Najmi, Member Dong-A ST Co. Human follicle 12-2013 Product Registration Ltd, 64, Stimulating License No. Board. Cheonho-daero, Hormone) Pack size: 5 and 10 983 dated 15-1- b. Brig. Amir dongdaemun- Prefilled Syringe 2010 Ikram, AFIP gu, seoul, Pharmacological Rawalpindi. Korea. group: MRP Legalized GMP c. Dr. Masud-ur- Gonadotropin Rs. 12600.00/- for No. 2013-EI- Rehman, DDG, single prefilled 0077 dated 27- DRAP, Indication: 6-2013 Islamabad. For the treatment of enclosed infertility 15. M/s Sind MENVAC ACYW Dy No.718 Dir (BD) Legalized Approved as per Medical Store, (Meningococcal Dated 03-12-2013 COPP No. Import Policy for Karachi Polysaccharide 2013-xx Finished Drugs and Vaccine – Group Fee Rs. 100000/- Dated 21-6- valid legailized Manufacturer ACYW 135) 1Dose dated 07-10-2013 2013 CoPP. Vial M/s Beijing Product ZhifeiLvzhu Each 0.5ml dose of Price. 1410.00/- Vial License No. Biopharmaceuti reconstitute vaccine of 0.5ml GuoYao cal Co., Ltd. contains 200µg ZhunZi S
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Tongjibeilu polysaccharide (50 Pack size 20070025 no.22, Beijing µg of each 01Vial x dated 15-11- Economic & polysaccharide of 0.5ml/1 Dose 2007. Technological group A, group C, Development group Y & group W Legalized Free Area Beijing- 135) Per Vial Sale Certificate P.R. China. No. [2015]-14- Vaccines / Biological 23 dated 29-5- Product 2015 16. M/s Sind STERILE WATER Dy No. 576 Dir Legalized Approved as per Medical Store, FOR INJECTION- (BD) dated 08-10- COPP No. Import Policy for Karachi 0.5 ML AMPOULE 2013 2012-xx dated Finished Drugs and (For the 07-12-2012 valid legailized Manufacturer reconstitution of Fee Rs. 50000/- CoPP. Meningococcal dated 07-10-2013 + Product JIANGSU Polysaccharide 50000/- datd 14-10- License No. DESANO Vaccine- Group 2013 GuoYaoZhun PHARMACEU A/C/Y/W 135 or Use Zi H20033903 TICAL CO., as a solvent for the Balance Fee Nil dated 14-11- LTD No.3, reconstitution of 2003 Kangan road, Sterilized powder / Free of Cost Economic & Lyophilized Technology Vaccines for Pack size Legalized Free Development injection)’ Sale Certificate District, Liyang Box of 10 Ampoules No. 2015-11 City, Jiangsu Composition: x 0.5mL dated 9-2-2015 Province, P.R. China Each 0.5ml per dose contains the following:
Active ingredients Water for Injection……0.5ml
17. Hakimsons VaxiRab-N Date of application Legalized Approved as per (Impex) (Pvt) Rabies Vaccine BP 29-10-2013 COPP No. Import Policy for Ltd. Karachi (Purified Chick MFG/CERTI/C Finished Drugs and Embryo Cell culture Fee Rs. 50000/- HCL/101212 valid legailized Manufacturer rabies vaccine) Dated 08-11-2013 Dated 26-12- CoPP. Cadila Each vial of 2012 Healthcare syophilized powder Unit price 770/- Limited contains: Product Sarkhej-Bavla Inactivated rabies License No. G- H. H. No. 8-A virus ( Pitman Moore VAC/1 Moraiya, Tal Strain Potency ≥2.5 No.AP/CHC/20 Sanand IU 12/CH/50373/ Ahmedabad B Dated 19-6- 382210, India. Pharmacological 2012
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group: GMP Anti-Rabies Vaccine Certificate No. 1201029 dated 27-1-2012 18. Getz Pharma MENOGET Out Dy No. 17 dated Legalized Deferred for (Pvt) Limited lyophilized Powder 28-2-2014 CoPP No submission of 29-30/27, for Injection 14115 dated following: Korangi 75IU/Vial Rs.100000/- dated 04-12-2014 a. Stability study Industrial Area, 06-11-2012 enclosed data of finished Karachi. (Bulk product. Import Local Each vial contains: Pack size and MRP Product b. Orignal sole Manufacturer) Menotropins License No. agency USP…75IU ( Unit Pack Size: 1 H20023863 agrrement. Human menopausal Vial with 1 dated c. Certificate of Manufacturer gonadotrophin, ampoule of diluent September, submission of HMG corresponding proposed/demanded 2010. fee from Shanghai to 75IU human MRP Rs. 1500/- Accounts Livzon follicle stimulating Legalized GMP section as copy Pharmaceutical hormone and 75IU Unit Pack Size: 5 No CN of challan is Co. Ltd. human luteinising Vial with 5 20130477 submitted. NO.1150, hormone) ampoules of diluent dated 11-12- d. Confirmation of Guiqiao Road, Proposed/ 2013. valid formulation in Jinqiao Export Demanded MRP Rs. until 10-12- reference drug Processing Gonadotropins and 7500/- 2018 enclosed agencies. Zone, Pudong, Ovulation Stimulants Shanghai, China Unit Pack Size: 10 Vial with 10 ampules of diluent Proposed/ Demanded MRP Rs. 15000/-
19. Getz Pharma MENOGET Out Dy No. 58 dated Legalized Deferred for (Pvt) Limited lyophilized Powder 04-3-2014 CoPP No submission of 29-30/27, for Injection 14116 dated following: Korangi 150IU/Vial Rs.100000/- dated 04-12-2014 a. Stability study Industrial Area, 06-11-2012 enclosed data of finished Karachi. (Bulk Each vial contains: product. Import Local Menotropins Pack size and MRP Product b. Orignal sole Manufacturer) USP…150IU ( License No. agency Human menopausal Unit Pack Size: 1 H20023864 agrrement. Manufacturer gonadotrophin, Vial with 1 dated c. Certificate of HMG corresponding ampoule of diluent September, submission of Shanghai to 150IU human proposed/demanded 2010. fee from Livzon follicle stimulating MRP Rs. 3000/- Accounts Pharmaceutical hormone and 150IU Legalized GMP section as copy Co. Ltd. human luteinising Unit Pack Size: 5 No CN of challan is NO.1150, hormone) Vial with 5 20130477 submitted. Guiqiao Road, ampoules of diluent dated 11-12- d. Confirmation of
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Jinqiao Export Gonadotropins and Proposed/ 2013. valid formulation in Processing Ovulation Stimulants Demanded MRP Rs. until 10-12- reference drug Zone, Pudong, 15000/- 2018 enclosed agencies. Shanghai, China Unit Pack Size: 10 Vial with 10 ampules of diluent Proposed/ Demanded MRP Rs. 30000/-
Shelf Life 02 years 20. Getz Pharma MENOCON Dy. No. 1650 R&I Legalized Deferred for (Pvt) Limited Lyophilized Powder dated 1-10-2012 CoPP No submission of 29-30/27, for Injection 1000IU 14112 dated following: Korangi Each vial contains 100000/- dated 01- 04-12-2014 a. Stability data of Industrial Area, Human Chorionic 10-2012 enclosed finished Karachi. (Bulk Gonadotropin (Hcg) product. Import Local USP…1000IU/vial Pack size and MRP Product b. Orignal sole Manufacturer) License No. agency Unit Pack Size: 1 H20033377 agreement. Manufacturer Gonadotropins and Vial Rs. 500/- dated a. Clarification Ovulation September, required, as you Shanghai Stimulants. Unit Pack Size: 5 2010. have submitted Livzon Vial Rs. 2500/- dossier of Pharmaceutical Legalized GMP finished import Co. Ltd. Unit Pack Size: 10 No CN however on the NO.1150, Vial Rs. 5000/- 20130477 covering letter it Guiqiao Road, dated 11-12- is mentioned Jinqiao Export Shelf Life 02 years 2013. valid that M/s Getz Processing until 10-12- will import the Zone, Pudong, 2018 enclosed bulk powder Shanghai, China from china and repack locally in their facility. 21. Getz Pharma MENOCON Dy. No. 1651 R&I Legalized Deferred for (Pvt) Limited Lyophilized Powder dated 1-10-2012 CoPP No submission of 29-30/27, for Injection 5000IU 14114 dated following: Korangi 100000/- dated 01- 04-12-2014 a. Stability data of Industrial Area, Each vial contains 10-2012 enclosed finished Karachi. (Bulk Human Chorionic product. Import Local Gonadotropin (Hcg) Pack size and MRP Product b. Orignal sole Manufacturer) USP…5000IU License No. agency Unit Pack Size: 1 H20033379 agreement Gonadotropins and Vial Rs. 1000/- dated c. Clarification Manufacturer Ovulation September, required, as you Stimulants. Unit Pack Size: 5 2010 have submitted Shanghai Vial Rs. 5000/- dossier of Livzon Legalized GMP finished import Pharmaceutical Unit Pack Size: 10 No CN however on the
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Co. Ltd. Vial Rs. 10000/- 20130477 covering letter it NO.1150, dated 11-12- is mentioned Guiqiao Road, Shelf Life 02 years 2013. valid that M/s Getz Jinqiao Export until 10-12- will import the Processing 2018 enclosed bulk powder Zone, Pudong, from china and Shanghai, China repack locally in their facility. 22. M/s CCL ARYOSEVEN Form-5A Legalized Free Deferred for expert Pharmaceuticals Injection 1.2mg sale certificate opinion of Lahore Dy. No 4470 dated dated 06-04- following: Each vial contains: 03-09-2014 2014 a. Gen. Muhammad Aryogen Zist Activated Eptacog Ayub. Comdt, Darou Co. 140 Alfa (human 50000x2 dated 03- Copy of GMP AFIP, RWP. Corner activated 09-2014 submitted dated b.Maj. Gen Tajbaksh street, recombinant 18-05-2014 Muhammad Aslam, 24 Km coagulation factor Member Makhsuous VII) …..1.2mg Registration Baord. Road, Alborz (60KIU) Iran Blood Coagulation Factor
For treatment and prevention from bleeding episodes in those undergoing surgery or invasive procedures: i. Congenital Hemophilia ii. acquired Hemophilia iii. Glanzmanns thrombbasth enia 23. M/s Genome VINRAB 1000 IU / Form-5A Deferred for Pharmaceuticals 5ml Vial (Rabies a. Duplicate dossier , Pvt Limited, Antiserum) Dy No 4565 dated submitted. Hattar 16-07-15 b. Copy of CoPP Each vial contains: provided which M/s VINS Bio Equine Rabies 15000/- dated 08- is also expired. products, Immunoglobulin 12-2010 c. Copy of Sole Survey No. 117 Fragments not less 35000/- dated 09- agency Thimmapur, than 1000 IU 10-2012 agreement is Kothur Mandal provided. Mahboobnager Specific 2200/- per vial d. Product is me Distt, AP India immunoglobulin too, differential fee is required
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24. M/s. Sind DIPHTHERIA Form-5A Legalized free Approved as per Medical ANTITOXIN B.P sale dated 03- Import Policy for Stores, 10ML/1 DOSE Dy No 2015 dated 02-2012 Finished Drugs and Karachi. Therapeutic 10,000 29-04-2014 valid legailized I.U. Legalized CoPP. M/s VINS Bio Each 1.0 ml 100000 dated 29-04- CoPP dated 05- 03-2014 products, contains: 2014 Survey No. 117 Enzyme refined, Thimmapur, Equine Diphtheria Rs.13,951.00/Vial Kothur Mandal Antitoxic of 10ml Mahboobnager Immunoglobulins Distt, AP India ………………≤ 1000 I.U. In-active ingredients: Cresol ….…. ≥ 0.25% v/v Sodium Chloride ………. ………..……...0.0 09 g/ml Glycine …… 0.0225 g/ml Water for Injection… q.s.
Indication: For the treatment of Diphtheria infection. 25. M/s. Sind HEALIVE 1.0ML Form-5A Legalized Approved as per Medical PFS CoPP Import Policy for Stores, Inactivated Dy. No 276 dated submitted dated Finished Drugs and Karachi. Hepatitis A 29-05-2013 05-05-2015 valid legailized Vaccine CoPP. M/s. Sinovac 15000 dated 17- Legalized FSC submitted dated Biotech Co., For Adult use 06-2011 05-09-2014 Ltd, Each 1.0ml No.39 Shangdi contains: 85000 dated 29- Copy GMP Xi Road, Inactivated HAV 07-2013 provided 17- Haidian antigen………… 04-2013 District, … 500µ Rs.2,240.00/ PFS Beijing,10008 Aluminum of 1.0ml /dose 5, China hydroxide (as aluminum) ….. .0.35-0.62 mg/ml
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Disodium hydrogen phosphate …………..q.s. Sodium chloride ... 8.5mg Sodium dihydrogen phosphate ………….. q.s. Water for injections.1.0ml
Indication: For the prevention of Hepatitis A infection in adults.
26. M/s. Sind HEALIVE 0.5ML Form-5A Legalized Approved as per Medical PFS CoPP Import Policy for Stores, Inactivated Dy. No 351 dated submitted dated Finished Drugs and Karachi. Hepatitis 17-01-2011 05-05-2015 valid legailized A Vaccine CoPP. M/s. Sinovac For Junior use 15000 dated 17- Legalized FSC submitted dated Biotech Co., 01-2011 05-09-2014 Ltd, Each 0.5ml No.39 Shangdi contains: 85000 dated 29- Copy GMP Xi Road, Inactivated HAV 07-2013 provided 17- Haidian antigen………… 04-2013 District, … 250µ Rs.1,400.00/ PFS Beijing,10008 Aluminum of 0.5ml /Dose 5, China hydroxide (as aluminum) ….. .0.35-0.62 mg/ml Disodium hydrogen phosphate …………..q.s. Sodium chloride ...4.25mg Sodium dihydrogen phosphate ………….. q.s. Water for injections.0.5ml
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Indication: For the prevention of Hepatitis A infection in children.
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Case No.05: Cases of Veterinary Imported Biological Drugs from Reference Countries
Registartion Baord approved Registration of products subject to inspection of manufacturer abroad as Per Import Policy for Finished Drugs and verification of storage facilities.
S.No. Name of Brand Name & Dy No & Document Decision Importer & Composition Date of details Manufacturer application/ (CoPP)/ Me Fee status/ too status Pack size/ Price 1. M/s Saadat PUREVAXTM Dy No. 869 Certificate of Keeping in view the International, FELINE 4 Vaccine Dir (BD) License and USDA approval Lahore dated 31-1- Inspection and information of Manufacturer Each 1mL dose of 2014 No.1300566 legalized CoPP, Merial, Inc injectable vaccine Fee Rs. dated 19-12- Registration Board 115 Transtech contains: 100000/- 2012 approved the Drive Athens, Freeze-dried pellet: dated 31-1- U.S product as per Georgia Feline 2014 Veterinary Import Policy for 30601, USA Rhinotracheitis Decontrolled/ License Finished Drugs. Virus, F-2 strain at 25x1 dose vial Number 298 4.9 least……10 TCID50 & 25x1ml dated 28-3- The firm shall Feline Calicivirus, F- vials of sterile 2008 submit separate 9 strain, at water diluent. application along 4.7 least……10 TCID50 USDA Code. with requisite fee Feline Panleukopenia 16E8.20 for registration of Virus, Johnson GMP diluent as per leopard Origin strain, Certificate requirement of 4.0 at least 10 FAID50 No. 1300569 registration if Chlamydia psittaci, dated 19-12- dersired so. strain 905, at 2012. 2.5 least……..10 ELD50 Stabilizer…….25- 35% Gentamicin……≤ 30 µg/ml Diluent: 1mL of sterile water
The Vaccine induces an immune response against feline rhinotracheitis, calict,
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and panleukopenia viruses and aids in the reduction of disease due to Chlamydia psittaci. 2. M/s Saadat EURICAN DHPPI2- Dy No. 2934 Orignal Keeping in view the International, L Vaccine. (R&I) dated legalized Free approval of Lahore 22-4-2015 sale certificate regulatory authority Manufacturer Each dose of Fee Rs. provided of of France and Merial Rue De injectable vaccine 100000/- dated 25-11- information of L ‘ Aviation, contains: dated 22-4- 2013 legalized CoPP, 69800 ST Freeze –dried pellet: 2015 Registration Board Priest France. Attenuated distemper Decontrolled/ approved the virus……≥104.0CCID 10 bottles of product as per 50 1dose of Import Policy for Attenuated canine freeze dried finished drugs and adenovirus type pellet with 10 as per valid 2..5 2……≥10 CCID50 bottles of 1ml legalized CoPP. Attenuated canine of suspension parvovirus….≥104.9C The firm shall CID50 submit separate Attenuated canine application along parainfluenza virus with requisite fee type2…….≥104.7CCI for registration of D50 diluent as per Excipient, requirement of qs…….1dose registration if Diluent: inactivated dersired so. leptospira canicola…….porency according to Ph. Eur Inactivated leptospira icterohaemorrhagie… .. potency according to Ph.Eur It is a live viral and inactivated bacterial hexavalent vaccine for dogs 3. M/s Saadat AIVNEW NEO Dy No. 2932 GMP Keeping in view the International, Live vaccine against (R&I) dated Certificate approval of Lahore Newcastle disease in 22-4-2015 No. 14/96489 regulatory authority Manufacturer Poultry prepared Fee dated 09-4- of France and Merial 29, from the lentogenic Rs.100000/- 2014 information of Avenue Tony VG/GA strain dated 22-4- legalized CoPP, Garnier 69007 Tablets of 1000 or 2015 Registration Board
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Lyon France. 2000 doses, approved the product as per Each dose of vaccine Unit price: Import Policy for contains at least 105.5 Decontrolled/ finished drugs. EID50 (Egg Infective 1000 doses Dose 50%) of x10 Newcastle disease 2000doses x virus, VG/GA strain 10 Pharmacological group: Effervescent live tablet vaccine against Newcastle disease. 4. M/s Saadat BDA BLEN Dy No. 2935 Certificate of Keeping in view the International, (R&I) dated licensing and USDA approval Lahore Each dose of vaccine 22-4-2015 Inspectin No. and information of Manufacturer contains: Fee Rs. 1500201 legalized CoPP, Merial, Inc Infectious Bursal 100000/- dated 12-11- Registration Board 1730 Olympic disese virus, 2512 dated 22-4- 2014 approved the Drive Athens, strain, at 2015 U.S product as per GA, USA least…..100EID50 Decontrolled/ Veterinary Import Policy for 30601 Bursal disese viral 1000doses License Finished Drugs. antiserum at x25 Number. 298 least……24Units 5000doses x dated 19-4- Getamicin……0.2mc 25 2013 g USDA Code Stabalizer…..0.0024 1271.0A ml GMP Certificate No BDA BLEN is a 1402237 virus-antibody dated 21-8- complex vaccine that 2014 contains a live strain of bursal disease virus of chicken embryo origin in conjunction with bursal disease antiserum.
5. M/s Saadat Recombitek® C6 Dy No.870 Keeping in view the International, Dir (Bio) USDA approval Lahore Each dose of 1ml dated 31-1- and information of Manufacturer injectable vaccine 2014 legalized CoPP, Merial, Inc contains: Fee Rs. Registration Board 115 Transtech Canine Distemper- 100000/- approved the
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drive, Athens Canrypox Vector dated 31-1- product as per 6.4 Georgia USA …….≥ 10 TCID 50 2014 Import Policy for Cannine Adenovirus Decontrolled/ Finished Drugs. Tye 2……..≥ 10 4.3 25 Unitsx1 TCID 50 dose with The firm shall Cannine 25units x1 submit separate Parainfluenza…..≥ 10 dose diluent. application along 3.9 TCID 50 with requisite fee Cannine Parvovirus for registration of ………≥ 10 3.3 TCID diluent as per 50 requirement of Stablizer…….25- registration if 35% dersired so. Gentamicin……≤ 30µg/ml
Each 1 ml dose of the diluent vaccine contains: Leptospira canicola……..≥40 nephelometric units Leptospira icterohaemorrhagiae …..……..≥30 nephelometric units Thimerosal……1:30 000 final concentation Residual free formaldehyde……≤0 .74g/L The vaccine induces an immune response against disease caused by: Canine Distemper Canarypox Vector Canine Adenovirus Type 2 Canine Parvovirus Leptospirosis 6. M/s Saadat LT BLEN Dy No. 2933 Certificate of Keeping in view the International, (Fowl (R&I) dated Licensing and USDA approval Lahore Laryngotracheitis 22-4-2015 Inspection and information of Vaccine, Modified No. 1500306 legalized CoPP,
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Manufacturer Live Virus Fee Rs. dated 19-11- Registration Board Merial, Inc 100000/- 2014 approved the 1730 Olymic Each dose of freeze dated 22-4- U.S product as per drive Athens dried vaccine 2015 Veterinary Import Policy for Georgia, USA contains: License No. Finished Drugs. Fowl Decontrolled/ 298 dated 19- Laryngotracheitis 25x1000 4-2013 Virus at least doses USDA Code. …….2.7 log 10 EID50 25x2000 1601.11 doses GMP Immunological 15x8000 Certificate doses No.1500307 Intra ocular/ oral dated 19-11- 2014.
7. M/s Marush CEVAC MD HVT & Fee Rs. Copy of Keeping in view the (Pvt) Ltd, RISPENS 15000/- dated Certificate of USDA approval, Lahore INJECTABLE 09-5-2011 Licensing and Registration Board Inspection approved the Serotypes 1&3, Live, enclosed product as per CEVA- frozen vaccine dated 13-1- Import Policy for BIOMUNE against very virulent 2014 Finished Drugs. Veterinary Marek’s Disease Biologicals US Veterinary Firm will submit company, Each dose contains: License No. orignal legalized 8901 Rosehill -Marek’s Disease, 368 CoPP along with road, Lenexa, HVT Strain & Cryo Establishment evidence of KS 66215 No…at least 3246 License date submission of USA PFU per dose at 23-12-1988 differential fee release & at least verified by Budgets 2164 PFU per dose Product & Accounts through expiration. License section. Chairman USDA Code will permit the -Marek’s Disease, 16L1.02 dated issuance of Rispens CV1988 25-5-2010 registration letter Strain & Cryo No…. at least 1983 PFU per Copy of dose at release & at Veterinary least 1322 PFU per Certificate dose through enclosed expiration.
Indication: For active immunization of healthy chickens and
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chick embryos against very virulent Marek’s disease.
Case No.06: Cases of Veterinary Imported Biological Drugs from Non Reference countries
Registartion Baord approved Registration of products subject to inspection of manufacturer abroad as per import policy for finished drugs and verification of storage facilities.
S.No. Name of Brand Name & Dy No & Date Document Decision Importer & Composition of application details (CoPP) Manufacturer Fee status/ Me too status
Pack size/ Price 1. M/s Ghazi EMULMAX-C Al +ND Dy No. 5 dated Legalized Free Deferred for Brothers, Ghazi 03-9-2009 Sale Certificate submission of House, D-35, Composition: provided vide following: K.D.A Scheme 15000/- dated Folio no a. Legalized No.1 Miran Inactivated Newcastle 08 Aug 2009 BOO.02.03.02.02 documents uhammad Shah disease virus, La Sota .1463/07 Dated i.e. CoPP or Read, Karachi strain………….0.0300 35000 dated 16-3-2007 Free sale ml 01-4-2015 certificate Name of Inactivated Type A GMP provided along with Manufacturer Avian Influenza Virus Dated 24-4-2009 GMP. Subtype Pack size b. Orignal fresh Investigacion H5N2…….0.0300 ml 500 ml/2500 Copy of Power of sole agency aplicada S.A. de (Strain doses Attorney agreement. C.V. 7 Norte No. A/CHICKEN/MEXICO enclosed with c. Differntial 416 Tehuacan, /232/94/CPA) application dated fee as Puebla, Mexico, 06-2-2009 required C.P. 75700 under the Indications: rules.
For the Prevention of H5 Avian Influenza and Newcastle disease. 2. M/s Ghazi EMULMAX-C AI Dy No. 2323 Legalized Free Deferred for Brothers, Ghazi R&I dated 03- Sale Certificate submission of House, D-35, Each 0.2 ml contains: 4-2015 provided vide following: K.D.A Scheme Folio no. a. Legalized No.1 Miran Inactivated Tpe A 15000/- dated BOO.02.03.02.02 documents uhammad Shah Avian Influenza virus 08-8-2009 .1465/07 Dated i.e. CoPP or Read, Karachi 16-3-2007 Free sale
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H5N2 subtype certificate Name of 0.0312 ml 35000/- dated GMP provided along with Manufacturer A/CHICKEN/MEXICO 01-4-2015 Dated 24-4-2009 GMP. /232/94/CPA) b. Orignal fresh Investigacion Pack size Copy of Power of sole agency aplicada S.A. de 500 ml/2500 Attorney agreement. C.V. 7 Norte No. Indications: doses enclosed with c. Differntial 416 Tehuacan, application dated fee as Puebla, Mexico, For the Prevention of 06-2-2009. required C.P. 75700 H5 Avian Influenza and under the Newcastle disease. rules.
3. M/s Ghazi EMULMAX AI Dy No. Legalized Free Deferred for Brothers, Ghazi 2325R&I dated Sale Certificate submission of House, D-35, Each 0.5 ml contains: 03-4-2015 provided vide following: K.D.A Scheme Folio no. a. Legalized No.1 Miran Inactivated Tpe A 15000/- dated BOO.02.03.02.02 documents uhammad Shah Avian Influenza virus 08-8-2009 .1466/07 Dated i.e. CoPP or Read, Karachi H5N2 subtype 16-3-2007 Free sale 0.075 ml 35000/- dated certificate Name of A/CHICKEN/MEXICO 01-4-2015 GMP provided along with Manufacturer /232/94/CPA) Dated 24-4-2009 GMP. Pack size b. Orignal fresh Investigacion 500 ml/1000 Copy of Power of sole agency aplicada S.A. de Indications: doses Attorney agreement. C.V. 7 Norte No. enclosed with c. Differntial 416 Tehuacan, For the Prevention of application dated fee as Puebla, Mexico, H5 Avian Influenza 06-2-2009. required C.P. 75700 virus. under the rules. 4. M/s Ghazi EMULMAX AI + ND Dy No. Legalized Free Deferred for Brothers, Ghazi 2326R&I dated Sale Certificate submission of House, D-35, Each 0.5 ml contains: 03-4-2015 provided vide following: K.D.A Scheme Folio no. a. Legalized No.1 Miran Inactivated Type A 15000/- dated BOO.02.03.02.02 documents uhammad Shah Avian Influenza virus 08-8-2009 .1464/07 Dated i.e. CoPP or Read, Karachi H5N2 subtype 10-4 Free sale 0.0730 ml 35000/- dated -2007 certificate Name of A/CHICKEN/MEXICO 01-4-2015 along with Manufacturer /232/94/CPA) GMP provided GMP. Pack size Dated 24-4-2009 b. Orignal fresh Investigacion 500 ml/1000 sole agency aplicada S.A. de Indications: doses Power of agreement. C.V. 7 Norte No. Attorney c. Differntial 416 Colonia For the Prevention of enclosed with fee as Centro H5 Avian Influenza and application dated required Tehuacan, Newcastle disease.. 06-2-2009. under the Puebla, Mexico, rules. C.P. 75700
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5. M/s Ghazi BIO-SHS VIVA Dy No. 8732 Legalized Free Deferred for Brothers, Ghazi R&I dated 06- Sale Certificate confirmation in House, D-35, Each 1000 DOSES OF 1-2014 provided vide reference drug K.D.A Scheme PRODUCT CONTAIN: Certificate No. agencies and No.1 Miran SHS 119/95-BR 50000/- dated 678/2012 expert opinion 5.3 uhammad Shah antigen…….10 EID50 23-12-2013 Dated 09-10- regarding Read, Karachi TRTV-BR antigen 2012 prevelance of ……….105.3EID50 Pack size starin and its Name of Copy of Power of therapeutic Manufacturer Oral/ Nasal/ Ocular/ 1000 doses Attorney need by spary with diluent enclosed with following: LABORATORIO 2000 doses application dated a. Prof. Dr. BIO-VET S.A., with diluent 19-7-2013 Khushi Rua Cel. Jose Indication: 5000 doses Muhammad Nunes dos with diluent Copy of GMP , UVAS Santos, It is recommended for 10000 doses Certificate Lahore. 63906730-000- the prevention of with diluent No.037/2012 b. Prof. Dr. Vargem Grande swollen Head Syndrome dated 09-10-2012 Masood Paulista Sao in reproductive fowls , enclosed with Rabani, Paulo-Brazil commercial laying hens application. UVAS, Reg No: SIPE-SP or broilers Lahore. 009859-1 c. Dr. Muhammad Arshad, Member Registration Board. 6. M/s Ghazi RAKSHA BIOVAC Dy No. 4685 Attested copy Rejecetd as not Brothers, Ghazi R&I dated 22- Free Sale permissible for House, D-35, Each dose contains 7-2013 Certificate No. import under K.D.A Scheme Foot and Mouth disease 17456/M3B/2012 PCT code No.1 Miran Vaccine Component IP 50000/- dated -6 Dated2612- 3002.3000 of uhammad Shah (Vet) 12-7-2013 2012 provided. Appendix-G Read, Karachi Contains Trivalent foot (List of items and Mouth Disease 30ml vial Legallized CoPP not importable Name of Vaccine inactivated No. from India) of Manufacturer antigens against O, A Dosage form: 17455/M3B/2012 Import Policy and Asia 1 strains. Emulsion for -2 dated 04-1- Order of Trade Indian Haemorrhagic intramuscular 2013. Policy Immunologicals Septicaemia vaccine injection. Limited Component IP (Vet) Copy of GMP Rakshapuram, Contains Formaldehyde Certificate No. Gachibowli, inactivated Pasteurella 2059/M3B/2013 Hyderabad, multocida culture. dated 17-4-2013 Andhra Pradesh, enclosed with India application Indication: Copy of Power of Raksha Biovac vaccine Attorney is indicated for enclosed
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prophylactic vaccination against Foot and Mouth disease and Product available Haemorrhagic in the country of Septicaemia disease in origin. Cattle, Buffaloes and calves. 7. M/s Ghazi RAKSHA-PPR Dy No. 4321 Legalized Free Rejecetd as not Brothers, Ghazi R&I dated 16- Sale Certificate permissible for House, D-35, Strength of active 7-2013 No. import under K.D.A Scheme ingredient(s) per unit 754/M3B/2012- PCT code No.1 Miran Each dose contains: 50000/- dated 10 Dated 2-2- 3002.3000 of uhammad Shah 31-5-2013 2012 provided. Appendix-G Read, Karachi Freeze dried PPR (List of items Antigen……….103TCI Pack Sizes Legalized CoPP not importable Name of D50 No. from India) of Manufacturer 100 doses/ 100 17455/M3B/2012 Import Policy Composition of diluent: ml diluent vial -2 dated 14-11- Order of Trade Indian 2014. Policy Immunologicals Each dose contains: Dosage form: Limited Multi dose live Attested GMP Rakshapuram, Di sodium hydrogen attenuated Certificate No. Gachibowli, orthophosphate freeze dried 2059/M3B/2013 Hyderabad, IP…….9.47 mg vaccine dated 17-4-2013 Andhra Pradesh, Potasium dihydrogen enclosed with India orthophosphate application of IP…..9.08 mg Sodium chloride Attested Power IP……8.50 mg of Attorney Water for enclosed injection……..Q.S
Indications:
It is recommended for the prophylactic vaccination against Peste des Petits Ruminants in sheep & goats 8. M/s Ghazi RAKSHAVAC-T Dy No. 4687 Copy of GMP Rejecetd as not Brothers, Ghazi R&I dated 23- Certificate No. permissible for House, D-35, Strength of active 7-2013 2059/M3B/2013 import under K.D.A Scheme ingredient(s) per unit dated 17-4-2013 PCT code No.1 Miran Each dose contains 50000/- dated enclosed with 3002.3000 of uhammad Shah attenuated tissue culture 12-7-2013 application Appendix-G Read, Karachi schizonts infected (List of items bovine lymphoblasts Pack Sizes Copy of Power of not importable Name of Attorney from India) of Manufacturer Composition: 2 dose, 5 dose enclosed dated Import Policy
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and 10 dose 09-3-2013 Order of Trade Indian Active Ingredient: vials Policy Immunologicals Theilena cell Legalized Free Limited concentrate……..Not Dosage form: Sale Certificate Rakshapuram, less than 2 x 106 Live attenuated No.754/M3B/201 Gachibowli, cells/dose frozen vaccine 2-3 Dated 26-12- Hyderabad, 2012 provided. Andhra Pradesh, Indications: India Legalized CoPP Rakshavac-T vaccine is Certificate No. recommended for 17455/M3B/2012 preventive vaccination -3 dated 14-11- agaist Tropical 2014. Theileriosis (Theileria annulata infection) in Product available cattle. in the country of origin. 9. M/s Ghazi BOLDEMAX A.P. Dy No. 4320 Legalized Free Deferred for Brothers, Ghazi R&I dated 16- Sale Certificate confirmation of House, D-35, Strength of active 7-2013 No 0896-2012 formulation in K.D.A Scheme ingredient(s) per unit, dated 19-12-2012 reference drug No.1 Miran Each 100ml contains:- 50000/- dated provided agencies. uhammad Shah Boldenone 16-7-2013 Read, Karachi undecylenate……..5.0 g Copy of Power of Pack Sizes Attorney enclosed Product License 100ml vial. Holder: Indications: Copy of GMP AGROVET Dosage form: Certificate No. MARKET S.A., Increase in weight gain, Injectable 4101-2012-AG- Av. Canada 3792 better development of Solution SENASA- – 3798 San Luis, bone- muscle, proteins DIAIA-SIP Lima, Peru synthesis, minerals Dated 06-2-2013 retention, appetite Manufacturer improve and food under Product conversion, help in License-holder: Anemic process (by stimulus of the PHARMADIX erythropoieses: red cells CORP. S.A.C formation). Indicated in CALLE Santa diseases tat cause Lucia 218 weakness, rickets, urbanizacion La fracture, and stress (post Aurora-Ate Lima surgical, weaning 3-Peru castrations, ambient changes and prolong summer and winter, among others). Its vehicle gives it a slow release and long actin.
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10. Hilton Pharma Medivac ND G7B Dy No. 196 Copy of GMP Deferred for (Pvt) Ltd. Emulsion R&I dated 12- Certificate No. submission of 13, Sector 15, 3-2014 085/MFJ/HK.340 following: Korangi Each dose (0.5ml) of /F.5/08/11 Dated a. Legalized Industrial Area, vaccine contains 100000/- dated 23-8-2011 until documents Karachi, Pakistan inactivated Newcastle 18-9-2013 valid 23-8-2016 i.e. Orignal disease virus MD15 CoPP or Free Manufacturer: strain at least 50 PD 50 sale Name: Pack Size certificate PT.MEDION Inactivated vaccine for along with poultry 500 ml GMP. JI.Raya Batujajar b. Orignal sole 29 cimareme, agency Kabupaten agreement. Bandung- c. Stability data Indonesia of finished product. Adress: Ji. Babakan ciparay No. 282 Bandung 40223 - Indoneshia 11. Hilton Pharma Medivac Coryza T Dy No. 543 Copy of GMP Deferred for (Pvt) Ltd. Suspension R&I dated 04- Certificate No. submission of 13, Sector 15, 6-2014 085/MFJ/HK.340 following: Korangi Strrength / Formulation /F.5/08/11 Dated a. Legalized Industrial Area, 100000/- dated 23-8-2011 until documents Karachi, Pakistan Each 0.5ml dose 04-6-2014 valid 23-8-2016 i.e. Orignal
contains: CoPP or Free Manufacturer: -Haemophillus Pack Size sale Name: paragallinarum W strain certificate PT.MEDION before inactivation 500 ml along with ≥ 2x108.0 CFU/ml GMP. JI.Raya Batujajar -Haemophillus b. Orignal sole 29 cimareme, paragallinarum Spross agency Kabupaten strain before agreement. Bandung- inactivation ≥ 2x108.0 Indonesia CFU/ml -Haemophillus Address: Ji. paragallinarum Modesto Babakan ciparay strain before No. 282 Bandung inactivation ≥ 2x108.0 40223 - CFU/ml Indoneshia Inactivated Suspension Vaccine against infectious coryza 12. Orient Animal Pestikal La Sota® SPF, Dy.No. 2407 Legalized Deferred Health (Pvt) Ltd, lyophilisate for (R&I) dated Product confirmation of Karachi suspension 07-4-2015 Marketing formaulation in
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authorization reference drug Manufacturer Each single dose Fee Rs. registration No. agencies along vaccine contains: 100000/- dated 525-10/1278-15- with expert GENERA d.d. 07-4-2015 2 dated28-1-2015 opinion of Svetonedjelijska Live lento genic Enclosed. following: 2, Kalinovica, Newcastle disease virus, a. Prof. Dr. 10436 Rakov La Sota strain ≥ 106.0 Unit price: Legalized GMP Khushi Potok, Croatia. EID 50 Decontrolled/ Certificate No. Muhammad, 25, doses. 409-8/2013-2 UVAS Pharmacological group: Box of 10 vial dated 17-4-2013 Lahore. Immunological for of 1000, 2500, enclosed b. Prof. Dr. domestic fowl live viral & 5000 vaccine Masood vaccine against doses Rabani, Newcastle disease UVAS, Lahore. c. Dr. Oculonasaly, Oral, Muhammad spraying Arshad, Member Registration Board.
13. Orient Animal Pestikal® B 1 SPF Dy.No. 2409 Legalized Deferred for Health (Pvt) Ltd, lyophilisate for (R&I) dated Certificate of confirmation in Karachi suspension 07-4-2015 GMP No. 409- reference drug 8/2013-2 dated agencies and Manufacturer Each single dose Fee Rs. 17-4-2013 expert opinion vaccine contains; 100000/- dated enclosed regarding GENERA d.d. 07-4-2015 prevelance of Svetonedjelijska Live lento genic Legalized Market starin and its 2, Kalinovica, Newcastle disease virus, authorization therapeutic 10436 Rakov strain Hitchner B 1 ≥ Unit price: Certificate need by 6.0 Potok, Croatia. 10 EID 50 (embryo Decontrolled registration No. following: infective dose 50) = Box of 10 vial 525-10/1278-15- a. Prof. Dr. virus dose which infects of 1000, 2500, 2 dated 28-1- Khushi 50% of inoculated & 5000 vaccine 2015 enclosed Muhammad, chiken embryos doses UVAS Lahore. Pharmacological group: b. Prof. Dr. Immunological for Masood domestic fowl live viral Rabani, vaccine against UVAS, Newcastle disease Lahore. c. Dr. Oculonasaly, Oral Muhammad Arshad, Member Registration Board.
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14. Orient Animal Gumbokal® IM FORTE Dy. No. 2408 Legalized Market Deferred for Health (Pvt) Ltd, SPF, lyophilisate for (R&I) dated authorization confirmation in Karachi suspension 07-4-2015 certificate reference drug registration No agencies and Manufacturer 1 dose of vaccine Fee Rs. 525-10/1278-15- expert opinion contains: 100000/- dated 2 dated 28-1- regarding GENERA d.d. 07-4-2015 2015. enclosed prevelance of Svetonedjelijska Attenuated live virus of starin and its 2, Kalinovica, Gumboro disease Unit price: therapeutic 10436 Rakov (infectious bursal Decontrolled Legalized GMP need by Potok, Croatia. disease), strain VMG 91 10x1000 doses Certificate No. following: 4.0 ≥ 10 TCID 50 10x 2000 doses 409-8/2013-2 a. Prof. Dr. 10x2500 doses dated 17-4-2013 Khushi Pharmacological group: 10x5000 doses enclosed Muhammad, Immunological UVAS formulation for birds, Lahore. farm poultry Live virus b. Prof. Dr. vaccine, virus of Masood infectious bursal disease Rabani, (Gubmoro disease) UVAS, Lahore. For active immunization c. Dr. of chickens with Muhammad inherited maternal Arshad, antibodies against Member Gumboro disease. Registration Board. Oral admintration 15. Orient Animal Bronhikal® I SPF, Dy. No. 2410 Legalized Market Deferred for Health (Pvt) Ltd, lyophilisate for (R&I) dated authorization confirmation in Karachi suspension 07-4-2015 certificate reference drug registration No agencies and Manufacturer One dose of vaccine Fee Rs. 525-10/1278-15- expert opinion contains: 100000/- dated 2 dated 28-1- regarding GENERA d.d. Attenuated live virus of 07-4-2015 2015. enclosed prevelance of Svetonedjelijska Avian infectious starin and its 2, Kalinovica, bronchitis, strain H-120 Unit price: therapeutic 3.5 10436 Rakov ≥ 10 EID50 Decontrolled/ Legalized GMP need by Potok, Croatia. 10x1000 doses Certificate No. following: Pharmacological group: 10x 2500 doses 409-8/2013-2 a. Prof. Dr. Immunological for aves, dated 17-4-2013 Khushi domestic fowl. enclosed Muhammad, UVAS For active immunization Lahore. of chickens from day b. Prof. Dr. old onwards to prevent Masood mortality, clinical signs Rabani, and lesions of the avian UVAS, infectious bronchitis. Lahore. c. Dr.
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Oculonasaly, in Muhammad drinking water, by Arshad, sparying Member Registration Board.
Case No.07 Misclleneous / Deffered Cases
Case No: i Following Products of M/s Getz Pharma Karchi are deferred in the 254th meeting of registration Board due for completion of applications, remaining fee, CoPP status, information regarding availability in country of origin and deliberations regarding requirement for bio- similarity of products. The firm informed that they have alredy submitted the said documents and requested for consideration of their case.
S. Name of Brand Name & Dy No & Date Document Remarks Decision No Importer & Composition of application/ details (CoPP) Manufacturer Fee status/ Pack size/ Me too status demanded Price 1. Getz Pharma, BASAGINE Dy No. 24 COPP No. a. Product is Approved as Karachi Solution for DDC (BD) CPP111202 available in per valid Injection dated 17-3- Dated 14-3-2012 name of legalized Manufacturer 100Units/ml 2014 valid until 13-3- basalin in CoPP 2015 the country subject to inspection of Gan & Lee Each ml contains; - Fee Rs. of origin as National Product mentioned manufacturer Pharmaceuticals, Recombinant 15000/- dated 20-6-2012+ License No. on the abroad as per No.8, Jingsheng Insulin S20050050 submitted Import North 3rd Glargine…..100 85000/- dated 30-7-2013 (filled in 10ml CoPP. Policy for Street, Golden Units / ml vial) b. Product is Finished
Bridge Science Drugs, Pack size and S20050051 available in Industrial Base, Pharmacological the country verification MRP: (filled in 3ml Tongzhou group: cartridge) dated of origin, of storage
District 10-5-2005 firm has facilities and (Antidiabetic) Unit pack Beijing,China. submitted fixation of Size: 1 MRP by GMP Certificate the 100000 Pricing Cartridge No. L5276 dated fee along Committee. Demanded 29-4-2010 valid with MRP: Rs. until 28-4-2015 legalized 1125/- CoPP. Bio-similarity 3 Cartridge data encosed MRP Rs.
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3375/-
5 Cartridge MRP Rs. 5625/- 2. Getz Pharma, INSULOG Solution Dy. No. 1178 COPP No. a. Product is Approved as Karachi for Injection in (R&I) Dated CPP120202 available in per valid Cartridge 100 14-11-2012 Dated 14-3-2012 name of legalized Manufacturer unit/ml. valid until 13-3- prandilin in CoPP Gan & Lee Fee Rs. 2015 the country subject to inspection of Pharmaceuticals, Each ml contains:- 100000/- of origin as mentioned manufacturer No.8, Jingsheng Insulin Lispro Dated 14-11- National product on the abroad as per North 3rd USP…… 100 units 2012 License No. submitted Import Street, Golden (rDNA Origin) Policy for Pack Size & S20063005 CoPP. Bridge Science (equivalent to Finished MRP: (10:1000U/Vial) b. Product is Industrial Base, 3.47mg) S20063004 (3ml: available in Drugs,
Tongzhou 300U/Cartridge) the country verification District Anti-Diabetic Unit pack dated 19-1-2006 of origin, of storage Beijing,China. Size : 1 firm has facilities and Cartridge GMP Certificate submitted fixation of MRP Rs. No. L5276 dated the 100000 MRP by 622/- 29-4-2010 fee along Pricing with Committee. 3 Cartridges legalized MRP Rs. CoPP. 1866
5 Cartridges MRP Rs. 3110/-
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Case No: ii.
Following products of M/s Gudia Corporation Karachi are considered in the 254th meeting of Registration Board and deferred the case for completion of registration applications, CoPP status, information regarding availability in country of origin and deliberations regarding requirement for bio-similarity of products. The applications have been evaluated and detailed below for consideration of registration board please:
Sr. Name of Brand Name & Type of Form Document Remarks Decision No Importer & Composition details (CoPP) Manufacturer Dy No & Date of application/ International Fee status/ Avalaibality
Pack size/ Me too status demanded Price 1. Gudia VIPEG Injection 80 Form-5A Legalized a. CoPP Deferred for Corporation, mcg CoPP provided is expert opinion of Karachi. Dy No. 6965 provided expired, valid following: Each 0.5ml dated 12-9-12 upto 07-06- a. Dr Tauqeer Virchow lyophilized vial Me too 2014. Raza, Biotech Pvt. contains:- 15000/- dated b. Product is NUST, Islamabad. Ltd, Survey 30-09-12 available in the country b. Dr. Huma No.172 (part), Peg interferon alfa- 85000/- dated of origin. Qureshi, Gagillapur 2b……..80mcg 13-9-13 c. Firm has PMRC, Village, submitted the Islamabad. Qutubullapur, Immunomodulator Pack of 9900/- clinical data c. Dr. Sami J. Rangareddy dated 1’s regarding the Khan, District safety and Hyderabad, efficacy of Andhra peg- Pradesh, interferon India. alpha 2b in chronic hepatitis C patients. d. Firm has also submitted comparative bioavailabilit y, pharmacokin etic and pharmacodyn
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amics study of PEG Interferon alpha 2b of Virchow biotch india with PEG Interferon alpha 2b of Fulford India. 2. Gudia VIPEG Injection 50 Form-5A Legalized a. CoPP Deferred for Corporation, mcg CoPP provided is expert opinion of Karachi. Dy No. 6967 provided expired, valid following: Each 0.5ml dated 12-9-12 upto 07-06- a. Dr Tauqeer Virchow lyophilized vial Me too 2014. Raza, Biotech Pvt. contains:- 15000/- dated b. Firm has NUST, Islamabad. Ltd, Survey 30-09-12 submitted the clinical data b. Dr. Huma No.172 (part), Peg interferon alfa- 85000/- dated regarding the Qureshi, Gagillapur 2b……..50 mcg 13-9-13 safety and PMRC, Village, efficacy of Islamabad. Qutubullapur, Immunomodulator Pack of 6200/- peg- c. Dr. Sami J. Rangareddy dated 1’s interferon Khan, District alpha 2b in Hyderabad, chronic Andhra hepatitis C Pradesh, patients. India. 3. Gudia VIPEG Injection Form-5A Legalized a. CoPP Deferred for Corporation, 100 mcg CoPP provided is expert opinion of Karachi. Dy No. 6964 provided expired, valid following: Each 0.5ml dated 12-9-12 upto 07-06- a. Dr Tauqeer Virchow lyophilized vial Me too 2014. Raza, Biotech Pvt. contains:- 15000/- dated b. Product is NUST, Islamabad. Ltd, Survey 30-09-12 available in the country b. Dr. Huma No.172 (part), Peg interferon alfa- 85000/- dated of origin. Qureshi, Gagillapur 2b……..100 mcg 13-9-13 c. Firm has PMRC, Village, submitted the Islamabad. Qutubullapur, Immunomodulator Pack of clinical data c. Dr. Sami J. Rangareddy 12000/- dated regarding the Khan, District 1’s safety and Hyderabad, efficacy of Andhra peg- Pradesh, interferon India. alpha 2b in chronic hepatitis C patients.
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4. Gudia VIPEG Injection Form-5A Legalized a. CoPP Deferred for Corporation, 120 mcg CoPP provided is expert opinion of Karachi. Dy No. 6966 provided expired, valid following: Each 0.5ml dated 12-9-12 upto 07-06- a. Dr Tauqeer Virchow lyophilized vial Me too 2014. Raza, Biotech Pvt. contains:- 15000/- dated b. Product is NUST, Islamabad. Ltd, Survey 30-09-12 available in the country b. Dr. Huma No.172 (part), Peg interferon alfa- 85000/- dated of origin. Qureshi, Gagillapur 2b……..120 mcg 13-9-13 c. Firm has PMRC, Village, submitted the Islamabad. Qutubullapur, Immunomodulator Pack of clinical data c. Dr. Sami J. Rangareddy 14000/- dated regarding the Khan, District 1’s safety and Hyderabad, efficacy of Andhra peg- Pradesh, interferon India. alpha 2b in chronic hepatitis C patients.
5. Gudia VIPEG Injection Form-5A Legalized a. CoPP Deferred for Corporation, 150 mcg CoPP provided is expert opinion of Karachi. Dy No. 6968 provided expired, valid following: Each 0.5ml dated 12-9-12 upto 07-06- a. Dr Tauqeer Virchow lyophilized vial Me too 2014. Raza, Biotech Pvt. contains:- 15000/- dated b. Product is NUST, Islamabad. Ltd, Survey 30-09-12 available in the country b. Dr. Huma No.172 (part), Peg interferon alfa- 85000/- dated of origin. Qureshi, Gagillapur 2b……..150 mcg 13-9-13 c. Firm has PMRC, Village, submitted the Islamabad. Qutubullapur, Immunomodulator Pack of clinical data c. Dr. Sami J. Rangareddy 17000/- dated regarding the Khan, District 1’s safety and Hyderabad, efficacy of Andhra peg- Pradesh, interferon India. alpha 2b in chronic hepatitis C patients.
6. Gudia HEALACE 0.01% Form-5A Regranex Gel a. CoPP Approved as per Corporation, Gel (FDA provided is valid legalized Karachi. Dy No. 6969 Approved) expired, valid CoPP subject to Each gram of gel dated 12-9-12 upto 07-06- inspection of Virchow contains: Legalized 2014. manufacturer b. Product is abroad as per
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Biotech Pvt. 15000/- dated CoPP available in import policy Ltd, Survey Recombinant 30-09-12 provided the country for finished No.172 (part), Human Platelet 85000/- dated of origin. drugs, Gagillapur Derived Growth 23-9-13 c. Firm has verification of Village, Factor submitted the storage facilities and fixation of Qutubullapur, (Becaplermin)…… Pack of preclinical toxicity data. MRP by Pricing Rangareddy ….100mcg 10000/- per Clinical data Committee. District tube of 15g is required. Hyderabad, Topical application Import Policy Andhra is indicated for Order, Ministry Pradesh, treatment of lower of Commerce India. extremity diabetic will also be neuropathic pain checked for ulcers that extend importability into the diabetic from india. issue beyond and have an adequate blood supply.
Case No: iii. Following products of M/s Novartis Pakistan Limited Karachi are deferred in the 254th meeting of Registration board for complete information regarding composition of product. The complete composition as submitted by the firm, same reflected on the CoPP is incorporated. The applications have been evaluated and detailed below for consideration of registration board please:
Sr. No Name of Importer Brand Name & Type of Form Document Remarks Decision & Manufacturer Composition details (CoPP) Dy No & Date of application/ International Fee status/ Avalaibality
Pack size/ Me too status demanded Price 1. M/s Novartis COSENTYX Form-5A Legalized Vial and PFS Approved as Pakistan Limited, Prefilled Pen CoPP issued syrige per valid Karachi Dy No. 77 by EMA approved in legalized th Each prefilled pen dated 11-02- dated 28-01- 254 meeting CoPP, import Manufacturer: in 1 ml contains: 2015 2015 is of reg. Board. policy for finished submitted. drugs, Novartis Pharm Secukinumab… 50000/- dated verification of
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Stein AG, …..150mcg 11-02-2015 New storage Schaffhauserstrasse molecule facilities and , CH-4332 Stein, Immunosuppressa 75000/- Pack fixation of Switzerland. nt , Interlukin 1’s. MRP by Inhibitor Pricing Committee.
Case No.iv: Following products of M/s Roche Pakistan are deferred in 254th meeting of registration Board for complete information regarding CoPP, free sale status, composition and indications. The requisite information is detailed below.
Sr. No Name of Brand Name & Type of Form Document Remarks Decision Importer & Composition details (CoPP) Manufacture Dy No & Date r of application/ International Fee status/ Avalaibality
Pack size/ Me too status demanded Price 1 Roche Kadcyla Vial Form-5A Legalized Product is Approved as per Pakistan COPP dated registed in valid legalized Limited, 37C, Each vila contains: Dy. No 3834 09-04-2014 is country of CoPP, import Block 6, dated 06-06- provided. origion as policy for PECHS, Trastuzumab 2015 mentioned in finished drugs, Karachi. emtansine EMA CoPP verification of ……100mg 50000/- Approved storage facilities powder for Treatment of and fixation of M. A Holder: concentrate for Not provided New molecule adult patients MRP by Pricing Roche infusion. /15ml type I with HER-2 Committee. Registration glass vial positive Limited, 6 Antineoplastic, unresectable Falcon way , Monoclonal locally advanced Shire Park, antibody or metatstatic Welwyn breast cancer, Garden, City who previously UK received trastuzumab and Manufactuere a taxane : separately r in DSM combination. Pharmaceutic als, Inc 5900 Martin Luther
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King Jr. Highway Greenville, NC USA
2 Roche Kadcyla Vial Form-5A Legalized Product is Approved as per Pakistan COPP dated registered in valid legalized Limited, 37C, Each vial contains: Dy. No 3835 12-.1-2015 is country of CoPP, import Block 6, dated 06-06- provided. origion as policy for PECHS, Trastuzumab 2015 mentioned in finished drugs, Karachi. emtansine ……160 EMA CoPP verification of mg powder for 50000/- Approved storage facilities concentrate for Treatment of and fixation of M. A Holder: infusion. Not provided New molecule adult patients MRP by Pricing Roche /20ml type I with HER-2 Committee. Registration Antineoplastic, glass vial positive Limited, 6 Monoclonal unresectable Falcon way , antibody locally advanced Shire Park, or metatstatic Welwyn breast cancer, Garden, City who previously UK received trastuzumab and Manufactuere a taxane : separately r in DSM combination. Pharmaceutic als, Inc 5900 Martin Luther King Jr. Highway Greenville, NC USA
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Case No.v:
Following veterinary vaccine products of M/s Mustafa Brothers Faisalabad are deferred for submission of balance fee and legalized CoPP in 256th meeting of Registration Board. The firm has submitted the documents. The evaluation is detailed below for consideration of Registration Baord please.
S. Name of Brand Name & Dy No & Date Document Remarks Decision No Importer & Composition of application/ details (CoPP) Manufacturer Fee status/ Pack size/ Me too status demanded Price 1. Mustafa Virus Vaccine Dy. No.600 State Firm has Deferred Brothers against infectious (R&I) dated Registration No. submitted the for Faisalabad. bursal disease from 12-6-2012 1047796296437 certificate fo submission BG strain “ARRIAH dated 11-8-2011 free sale of valid Manufacturer GUMBORO VAC” issued by the legalized director of documents Contains:- Fee the firm, free i.e. CoPP Federal Infectivity of the virus Rs.15000/- DML No.00-11- sale or Free Governmental vaccine shall be at dated 12-6- 1-001221 dated certificate or sale Budgetary least 2012 + 11-8-2011 CoPP issued certificate Institution 104.5EID50/cm3 One 85000/- dated by the with GMP, “Federal Centre dose of the vaccine 01-2-2016 GMP Regulatory issued by for Animal shall contain 103 Registration N body of the the Health” (FGBI EId50 Balance Fee 4-4060 enclosed country of regulatory “ARRIAH”, (Vaccine). Nil origin is agency of Vladimir, Pharmacological required. country of Russia. group: origin with certified Vaccine. English translation. 2. Mustafa Vaccine against Dy No. 599 Product Firm has Deferred Brothers chicken infectious (R&I) dated Registration No. submitted the for Faisalabad. bronchitis from strain 12-6-2012 1023/301283720 certificate of submission “H-120” strain live Fee Rs. Dated 26-7- free sale of valid Manufacturer dry Contains:- 15000/- dated 2011 issued by the legalized director of documents 12-6-2012 + the firm, free i.e. CoPP Federal One immunizing 85000/- dated State sale or Free Governmental vaccine dose contains 01-2-2016 Registration No. certificate or sale 4 Budgetary not less than 10 1047796296437 CoPP issued certificate Institution EID50 of the chicken Balance fee Dated 26-12- by the with GMP, “Federal Centre infectious bronchitis Nil 2011 Regulatory issued by for Animal virus (‘H-120” strain, body of the the Health” (FGBI serotype Legalized Free coutry of regulatory “ARRIAH”, Massachusetts). sale Certificate origin is agency of
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Vladimir, Registration N required. country of Russia. Pharmacological 1-2347 enclosed origin with group: certified Vaccine GMP English Registration N translation. 4-4060 encosed.
3. Mustafa Associated Vaccine Date of DML No. 00- Firm has Deferred Brothers Against Newcastle application 11-1-001220 submitted the for Faisalabad. Disease 12-Jun-2012 Dated 11-8- certificate of submission Infectious Chicken 2011 enclosed. free sale of valid Manufacturer Bronchitis and egg Fee issued by the legalized director of documents drop syndrome-76 Rs.15000/- Legalized Free the firm, free i.e. CoPP Federal inactivated emulsion dated 12-6- Sale Certificate sale or Free Governmental 2012+ 85000/- No. N 1-2346 certificate or sale Budgetary Pharmacological dated 01-2- encosed. CoPP issued certificate Institution group: 2016 by the with GMP, “Federal Centre Vaccine for Balance Fee GMP Certificate Regulatory issued by for Animal prevention of NIL No. N 4-4060 body of the the Health” (FGBI Newcastle Disease copy enclosed. country of regulatory “ARRIAH”, Infectious Chicken Packing of origin is agency of Vladimir, Bronchitis and egg 400 doses in a required. country of Russia. drop syndrome-76 in bottle. origin with certified breeding and English marketable pultry translation. farms and farms of other categories that have poultry. 4. Mustafa Virus vaccine against Dy No. 596 Prod Reg No. Firm has Deferred Brothers Bursal disease from (R&I) dated 1023301283720 submitted the for Faisalabad. Winterfield Disease 12-6-2012 Dated 26-7- certificate of submission 2512 strain 2011 free sale of valid Manufacturer Fee Rs. issued by the legalized director of documents One Immunizing dose 15000/- dated GMP No. 0011- the firm, free i.e. CoPP Federal of vaccine shall 12-6-2012 1-001221 sale or Free Governmental contain: 26-12-2011 certificate or sale Budgetary 4,0 lg EID50 of 85000/- dated CoPP issued certificate Institution attenuated virus of 01-2-2016 Free Sale by the with GMP, “Federal Centre infectious bursal Certificate No. Regulatory issued by for Animal disease of Winter Balance Fee 4-4078 body of the the Health” (FGBI field strain 2512 Nil coutry of regulatory “ARRIAH”, origin is agency of Vladimir, Composition: required. country of Russia. origin with certified Active substances: English Virus of infectious translation.
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bursal disease (IBDV) (strain Winterfield- 2512), titer of infectivity at lease 6.0 3 lg EID50/cm .
Pharmacological group: The vaccine is used for prophylactic immunization of chickens and chicks against infectious bursal disease.
5. Mustafa Virus Vaccine Dy. No.600 State Firm has Deferred Brothers against infectious (R&I) dated Registration No. submitted the for Faisalabad. bursal disease from 12-6-2012 1047796296437 certificate of submission BG strain “ARRIAH dated 11-8-2011 free sale of valid Manufacturer GUMBORO VAC” issued by the legalized director of documents Contains:- Fee the firm, free i.e. CoPP Federal Infectivity of the virus Rs.15000/- DML No.00-11- sale or Free Governmental vaccine shall be at dated 12-6- 1-001221 dated certificate or sale Budgetary least 2012 + 11-8-2011 CoPP issued certificate Institution 104.5EID50/cm3 One 85000/- dated by the with GMP, “Federal Centre dose of the vaccine 01-2-2016 GMP Regulatory issued by for Animal shall contain 103 Registration N body of the the Health” (FGBI EId50 Balance Fee 4-4060 enclosed country of regulatory “ARRIAH”, (Vaccine). Nil origin is agency of Vladimir, Pharmacological required. country of Russia. group: origin with certified Vaccine. English translation.
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Case No. vi: Following veterinary vaccine products of M/s Mustafa Brothers Faisalabad are deferred for confirmation of remaining fee and valid documents. Moreover, authentic English version of documents will be provided by the firm in 254th meeting of Registration Bard. The firm has submitted the documents. The evaluation is detailed below for consideration of Registration Baord please.
S. Name of Brand Name & Dy No & Document Remarks Decision No Importer & Composition Date of details (CoPP) Manufacturer application/ Fee status/ Me too status Pack size/ demanded Price 1. Mustafa Brothers Hypophysin® LA Dy No. 202 Legalized/ Firm has Deferred for Faisalabad. injectable Solution (R&I) dated notarized CoPP submitted expert opinion Each 1ml contains:- 26-3-2010. No. the of following: Manufacturer Carbetocin…… 23-A-2-0616/09 legalized a. Prof. Dr. Veyx-Pharma 0.07mg Fee dated 18.6.2009 CoPP Ejaz B.V., Chlorobutanolum Rs.15000/- issued on Ahmed, Forellenwegm SJ hemihydrate…2.00mg dated 25-3- New CoPP No. 10-07- VC Raamsodonksveer, Sodium Acetate 2010 + DEGU 93 dated 2014, Imperial The Netherlands, trihydrate….0.5mg 85000/- dated 10th July, 2014 however University Vexy Pharma Acetic Acid, 21-3-2013 the Lahore. Germany glacial…..3.0mg Product in on submitted b. Dr.Nassem WFI….1,4004.43mg Balance Fee market in CoPP has , UVAS, Packing and final (Minux ‘X’, see Nil exporting different Lahore. release: below) Sod. country. excipients c. Dr. Abus Vexy Pharm Hydroxide....0.8mg Pack size from the Samad, GmBH Soherweg, (X=20% solution to 10ml Vial Prod Reg No. earlier Ripah Schwarzenhon, adjust the pH-value) 20ml Vial 3100171-00-00 submitted University, Germany Endogenous 50ml Vial dated 19-12- CoPP. Lahore. posterior pituary 2003 lobe hormone Product For animal use Oxytocin available in For Veterinary use the country of GMP Certificate only. origin. No. NL/V 12/0006 Weak contarctions retained sfter birth as a result of uterine atony supporting the treatment of the mastitis Metritis agalactia syndrome, inadequate milk letdown, synchronized
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farowing in combination with adm of PGF alpha 2a but not before 114th day of getstion.
2. Mustafa Brothers Formol Vaccine Dy. No. 246 Free sale Copy Free Approved. Faisalabad Against Pasteurellosis (R&I) Dated certificate from sale As CoPP was of Cattle And Buffalos 28-5-2011 Russia provided. certificate submitted at Semi-Liquid, 27-08-2010 time of Manufacturer Aluminium Hydroxise Fee Rs. GMP- and GMP registration Composition in 15000/- dated de/15/001/08 dated 13- application, Federal State complete 28-5-2011 + DATED 13-2- 02-2008 thus the Board Unitary Enterprise -active constituent of 85000/- dated 2008. GMP are advised the “Stavropol Pasteurella multocida 01-2-2016 certificate issued provided firm to Biofactory” (serotype B), The by German and provide valid Russia. concentration of Balance fee Bulgarian original microbiological cells Nil authorities. legalized in the vaccine must be Certificate from documents i.e. not less than 6 Russia provided CoPP/ Free Milliard/cm3; which is sale and -phosphate- buffer legalized and GMP. The suspension is notarized but due Chairman aluminum hydroxide to Russian permit as sorbent 7.5%; language, the issuance of -in-activant formalin- certificate can registration practically is not not be assessed. letter after revealed. verification of (Immunity Biological storage preparation vaccines). facility of importer and inspection of manufacturer abroad as per import policy.
3. Mustafa Brothers Flu Proket H5 Dy No. 245 CoPP No. Copy Free Approved. Faisalabad Vaccine Against Birds (R&I) dated 08/2010/BG sale As CoPP was Influenza Inactivated 28-5-2011 Dated 15-2- certificate submitted at Emulsified Flu Protekt 2010. 27-08-2010 time of Manufacturer H5 Fee Rs. and GMP registration Composition in 15000/- dated GMP No. dated 13- application, Federal State complete (Immunity 28-5-2011 + DE/15/001/2008 02-2008 thus the Board Unitary Enterprise Biological 85000 dated Dated 13-2-2008 are advised the “Stavropol preparations. 01-2-2016 provided firm to Biofactory” Homogeneous water provide valid Russia. emulsion of ethe white original
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or white-pink color). Balance Fee legalized Nil documents i.e. CoPP/ Free sale and GMP. The Chairman permit issuance of registration letter after verification of storage facility of importer and inspection of manufacturer abroad as per import policy.
Case No.vii:
M/s Barrett and Hodgson Pakistan Submitted that following of their two products are deferred for expert opinion in 253rd Registration Board meeting. These products are the line extensions of their registed product BOTOX. The applied products will be imported from the same source, which are USFDA, MHRA, TGA and Health Canada approved. Firm has submitted the copies of copies of SPC & PI’s for reference. The firm further informed that as per decision of 250th meeting of Registration Baord that it is decided
“Registration Board discussed the requirement of taking expert opinion and deliberated that it is not mandatory to take expert opinion about a molecule/ formulation, if it is already approved (in same dosage form and strength) by regulatory agency of any of the reference country viz. USFDA, Health Canada, EMA, TGA Australia, PMDA Japan, MHRA United Kingdom, Germany, France, Switzerland, Netherlands, Austria, Denmark, Sweden and Norway. However Registration Board can take views / opinion of experts (if requires) regarding safety and efficacy parameters of the drug under domestic circumstances / practices, risk-benefit ratio in light of existing therapies etc.”
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The firm has requested for grant of registration.
Sr. No Name of Brand Name & Type of Form Document Remarks Decision Importer & Composition details (CoPP) Manufacturer Dy No & Date of application/ International Fee status/ Avalaibality
Pack size/ Me too status demanded Price 1. Barrett BOTOX powder Form-5A CoPP No. Botax 100 mg Approved as Hodgson for solution for 148/60/2. is already per valid Pakistan injection 10.12.2010 GMP.2678 registered legalized CoPP, (Private) Ltd dated under reg N. Import Policy Each vial Deposited Fee 31/10/2002. 018959, dated for Finished Allergan contains: 15000+ 35000 Free Sale 07.4.1996 (M- Drugs, Pharmaceutical Botlinum toxin Certificate 118) verification of s Ireland Type A……50 storage Allergan Units facilities and fixation of Neurotoxin MRP by complex blocks Pricing peripheral acetyl Committee. choline release at presynaptic cholinergic nerve terminals 2. Barrett BOTOX powder Form-5A CoPP No. Botax 100 mg Approved as Hodgson for solution for 148/60/2. is already per valid Pakistan injection 10.12.2010 GMP.2678 regisreted legalized CoPP, (Private) Ltd dated under reg N. Import Policy Each vial Deposited Fee 31/10/2002. 018959, dated for Finished Allergan contains: 15000+ 35000 Free Sale 07.4.1996 (M- Drugs, Pharmaceutical Botlinum toxin Certificate 118) verification of s Ireland Type A……200 storage Allergan Units facilities and fixation of Neurotoxin MRP by complex blocks Pricing peripheral acetyl Committee. choline release at presynaptic cholinergic nerve terminals
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Case No. viii: The Registration Board in its previous meeting was apprised by Mr. A.Q. Javed Iqbal (Member Registration Board) about the prevalent situation regarding availability of vaccines esp. Meningococcal vaccine which is required for Hajj Pilgrims as M/s GSK Karachi is only registration holder of the said vaccine and may be unable to supply the vaccine to Hajj Pilgrims due to its merger with M/s Sanofi. He also emphasised that the Federal Govt has set a priority for out of queue approvals of vaccines and life saving drugs (anticancer & Thalasemicdrugs)
M/s LDS Pvt Limited, 57/1 A Satellite Town, Rawalpindi has submitted an application for registration of above said vaccine. Same vaccine has also on agenda applied by M/s Sind Medical Store Karachi, which was also considered in 254th meeting and deferred for completion of documents. The said vaccine is also on agenda item of vaccines imported from non reference countries.
S. Name of Importer & Brand Name & Dy No & Date Document Decision No Manufacturer Composition of application/ details (CoPP) Fee status/ Pack size/ Me too status demanded Price 1. LDS Pvt Limited, Quadri Meningo Dy. No 131- Free sale Approved. 57/1 A Satellite DDC-BD dated certificate No. Free sale Town, Rawalpindi Each dose of 22-01-2015 XXF/837/6828 certificate for 0.5ml lyophillisate dated 1-3-2008 2008, thus the Bio-Med (P) Limited, contains: 100000/- Board advised C-96, Bulandshar Dated 22-1- the firm to Road Industrial area, 50µg 2015 provide valid Ghiziabad, India Polysaccharide original vaccine of each legalized serogroup (A,C, Y Pack of 1’s / documents i.e. & W135) of 1050/- CoPP/ Free sale Nisseria Pack of 10’s/ and GMP. The Meningitidis 7900/- Chairman will permit issuance of registration letter after
verification of
storage facility of importer, inspection of manufacturer abroad as per
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import policy and MRP fixation by the Pricing Division.
Case No. ix: Following product of M/s ICI Pakistan Karchi are deferred in the 254th meeting of Registration Board due to deferred for confirmation of indications, CoPP status including availability in country of origin. The application has been evaluated as per said reasons. The evaluation is detailed below:
S. Name of Brand Name & Dy No & Date Document Remarks Decision No Importer & Composition of application/ details (CoPP) Manufacturer Fee status/ Pack size/ Me too status demanded Price 1. M/s ICI Receptal Dy. No 360 CoPP No. 36- Firm has Approved as Pakistan Injectable dated 14-04- 1092/14 dated applied per valid Karachi Solution 2014 1212-2014 from multiple legalized Germany volumes, CoPP, MA Holder: Each ml of 15000/- dated however in Import Intervet solution for 04-11-2010 Prod Reg No. case of Policy for Deutschland injection 2104-0000, 15- injectable Finished GmBH, contains: 35000/- dated 2198 dosage forms Drugs and Unterschleissh 09-10-2012 single volume verification eim, Germany. Buserelin 50000/- dated with single of storage acetate 4.2 04-02-2014 registration No facilities. Manufacturer: micrograms is granted. Intervet (corresponding Pack of 2.5, International to 0.4 5ml, 10ml & Product is GmbH, micrograms 50ml available in Unterschleissh buserelin) country of eim, Germany. origin (Gonadotropinre leasing Legalized valid hormone). CoPP is submitted. (For Veterinary Use). Bovine: For treatment if infertility, linked to follicular cysts, For the
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improvement of pregnancy rate, following injection at the time of AI or during the leuteal phase. For the synchronization of oestrus and ovulation (allowing fix time AII in conjunction with prostaglandin F2 alpha or progetstgen administration.
Case No.x: Request of cancellation of Fluarix Vaccine reg. No 022612
Director Regulatory GSK Karachi Affairs has requested for cancellation of license of Flurix Vaccine reg. No 022612 due ti its discontinuation at global level and due to availability of alternate vaccines flu vaccines in local market. The firm submitted an affidavit stating license of above mentioned product may be cancelled and no legal proceeding pending against product in the court, along with other documents. Firm further informed that newer version of flu vaccine i.e. Quadrivalent (QIV) Flu vaccine Fluarix Tetra is introduced by GSK which is not yet registered and they are in discussion with global office for filing its registration in Pakistan. Decision: Registration Board deferred the case for personel hearing of firm’s representatives and confirmation of alternate brands available.
Case No. xi: Case of M/s. Graton Pharma, Karachi for registration of Interferon Alfa 2B 3000IU /Vial (Lipheron from Beijing Shanglu, China) along with diluent.
The firm M/s. Graton Pharma, Karachi has informed that they applied for the registration of Interferon Alfa 2b 300MIU injections 22.6. 2011 but their application has not been considered Minutes for 257th Registration Board Meeting 358 in any meeting till date .The firm has provided evidence of documents and fee challans submitted by them. 2. The case of the firm belongs to pre devolution at the time to Drugs Control Organization, Ministry of Health. The section tried to retrieve the application from old record but still the record is not found. Copy of GMP shows its validity till 14.03.2015. Copy of CoPP has also been provided by the company.
Earlier Decision of the Board: The Board deferred the case for completion of documents by the firm and to present the case with all available details in the next meeting of Registration Board.
M/s Graton Pharma, Karachi as has requested in the previous meeting for the import of their interferon. The case was considered and deferred for provision of original documents. The firm has submitted photocopies of their documents. In the instant shifting of record of biological division and touring abroad of DDC (BIO) their file are not traceable instantly. 2. The firm has also submitted documents regarding registration of steroil water for injection for their products. They have provided on form-5 CD version of registration dossiers, certificate of pharmaceutical product (Photocopy). However the firm has not submitted additional fee required for water for injection and that promised to submitted at the earliest before issuance of any letter regarding inspection abroad are registration letter. 3. The Board may consider their case on merit, whereas biological division is retrieving their documents and shall present before the Board as soon as they are available. Meanwhile the process of foreign inspection as per import policy may be considered and the firm may be directed to give undertaking on judicial stamp paper that outcome of the inspection what so ever will not confer the right of consideration if the firm could not qualify for the GMP certification. The firm shall be exempted from inspection, if their inspection has waiver as per import policy. It is a similar case of finished import for which policy decision has been asked however the case is pending since Ministry of Health before the DRAP Act 2012. Decision of 254th RB: The Registration Board upheld the previous decision and deferred the case for completion of documents by the firm as no any new documents/files was submitted by the firm.
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The firm has provided undertaking on the stamp paper dated 07-12-2015 as follows: In continuation with our application for registration of Interferon Alpha 2b 300MIU injection (LIPHERON 300IU) dated 22.6.2011. It is stated we have provided evidence of documents & fee challan submitted to biological division of DRAP. Our case belongs to pre devolution at the time to drug control organization, Ministry of health. Our application record due to shifting of record is not traceable instantly by biological division of DRAP. We have submitted on request of biological division of DRAP photocopies of following documents on 20th November 2015 via R&I Unit DRAP TF Complex 1) Copy of (lipheron 300iu) dossier 2) Copy of water for injection dossier 3) Copy of COPP 4) Copy of GMP 5) Copy of challans Firm is in process of getting fresh COPP & GMP & these documents legalized & attested by embassy of Pakistan in PR CHINA, it is going to take 3-4 months. Firm has requested that case should be approved on merit & as per import policy process of foreign inspection should be done to save our time. The Firm undertake to submit fresh COPP & GMP duly legalized & attested by embassy of Pakistan in PR CHINA, before getting final approval by honorable registration board & registration letter. S.No Company Name of Name of Date of Documentary Name Manufacturer Products application / Details Fee status 1. M/s Graton Beijing SL Recombinant Date of CoPP No. Pharma office Pharmaceutical Human application 20150204 dated # 102, First Co., Ltd. Interferon alfa 10-2-2015 Floor, The No.9. 2b for injection Plaza, Block-9 Zhongyuan Strength: 3M Fee Deposited Prod License Clifton, Road, Badachu IU/vial Rs.15000/- No. S20100501 Karachi. High Tech. dated 22-6- dated 18-9- Park, 2011 + 2010. Shijingshan 35000/- dated District, 09-10-2012+ GMP Certificate Beijing, 50000/- dated No. CN P.R.China 11-6-2015 20130327
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DATED 31-10- 2013 Free Sale Certificate No. 2015-14 dated 02-1-2015 validity 02 years.
Note. Photocopy of the COPP which is not legalized and not notarized bears the date 10-2-2015 whereas the dossier was submitted on 20-6-2011.
The case is holistically placed before the board for a decision as per policy adapted for NON SRA countries and considering the above documentary details.
The Registration Baord in its 256th meeting decided as follows: “Registration Board upheld its previous decision and deferred the case for completion of documents by the firm, as firm has still not submitted any new documents/files”
The firm has now submitted the legalized CoPP No. 20150204 dated 10-2-2015 Prod License No. H20100501 dated 18-09-2010. Submitted for consideration of Registration Board please.
Decision: Registration Board considered the case and referred the above application of the firm for expert opinion by following experts. Further processing will be done after expert opinion a. Brig (R), Muzamil Hussain Najmi, Member Registration Board. b. Brig. Amir Ikram, AFIP Rawalpindi. c. Dr. Masud-ur-Rehman, DDG, DRAP, Islamabad.
Case No. xii: Case of M/s. Pfizer Pakistan Limited, Karachi for the Registration of Sayana Press 104mg/0.65ml Medroxyprogesterone acetate.
M/s Pfizer Pakistan Limited, Karachi, wherein they informed that their product namely, Sayana Press still pending for registration for almost 3 years, the case was considered in 240th meeting of the Registration Board held on 7th November, 2013. The period of 2 years lapsed and it unfortunate that patients of Pakistan could not benefit from the same. Because Pfizer Inc. continuously engaged making several efforts to globally enhance access to voluntary family planning globally. Now their period has lapsed and its requested to remove the condition of supply for 2 years free of cost to females belonging to poor and low income group. Details as below:
Minutes for 257th Registration Board Meeting 361
S.No. Name of Brand Name / Decision of 240th Remarks company and Composition of RB Meeting manufacture Drugs 1 Pfizer Pakistan Sayana Press Approved. New Molecule Limited, Karachi 104mg/0.65ml However, (Medroxyprogesterone comments of Condition of Pfizer acetate) Directorate of 240th meeting of manufacturing Cost & Pricing RB; Belgium NV, Pre-filled injection will be taken on Rijksweg 12, system contains Depo- firms submission For initial at least 2870 Puurs medroxyprogesterone about MRP. two years the Belgium. acetate (DMPA) product will be 104MG/0.65ML supplied free of cost to females Main indications; belonging to Contraceptive, depot poor and low effective for at least income group, 13 weeks. Costing data will be provided to DPC
Decision: Registration Board acceded to request of the firm and removes the condition of supply for two years for free of cost supply as the stipulated time has been passed. Registration Board advised to refer the case to Pricing Division for MRP fixation
Minutes for 257th Registration Board Meeting 362
Case No. xiii: Case of M/s. Marush (Pvt) Limited , Lahore for the Registration of Sterile diluent
The case was deferred in 256th RB Meeting for clarification for use of diluent. The firm now submitted that the firm will use the below mentioned diluent in their already registered veterinary products (CEVAC MD RESPEN) Reg, No. 077532 and Vectromune HVT NDV Reg No. 079620 and for approved products awaiting issuance of registration letter in 254th meeting of RB.
S.No Company Name of Products Date of Documentary Decision Name / application / Details Manufacturer Fee status
1. M/s Marush Sterile Diluent Date of Certificate of Approved (Pvt) Ltd. K application Licensing and as per 123, Model Each 1000 ml contains: inspection No Import Town Lahore 1400671 dated Policy for Sucrose 10.0 g Fee deposited 30-12-2013 Finished NZ Amine AS 4.0 g 50000/- dated Drugs and CEVA- Sorbitol 45.0 g 08-12-2014 US Veterinary as per valid BIOMUNE K2HPO4 1.20 G License No. legalized Veterinary KH2PO4 0.50 G Balance fee 368 CoPP. Biologicals Phenol Red 0.02 g Nil company 8901 Demonized Water qs Prod Lic Code Resohill Road, to 10000ml 16N1.R0 dated Lenexa, Ks 5-6-2007 66215 USA.
Minutes for 257th Registration Board Meeting 363
Item No.IV: Cases referred by Quality Assurance & Laboratory Testing Division.
Case No.01 Manufacture and Sale of Substandard “Alakalizer Syrup” (Sodium Acid Citrate) Batch No. 241 By M/s Drug pharm (Pvt) Ltd .Lahore F. No. 3- 31/2015-(QC)
The Federal Inspector of Drugs, Lahore, drew sample from manufacturer’s premises on 12-02-2015. The Federal Government Analyst, CDL Karachi, declared the sample Substandard on the basis of assay vide Test Report No..LHR29/2015 dated 16th April 2015. On explanation letter issued by the FID, the firm challenged the CDL report and requested for Appellate Testing under Section 22(5) of Drugs Act, 1976. The Appellate Laboratory has also declared the sample as Substandard vide their test report 021-MNHRS/2015 dated 13th August 2015.
Result of CDL
Assay for Determined amount/5ml Statedamount/5ml Percentage
Sodium Acid Citrate: 0.622g 1.25g 49.76%
Limits:- 90.0% to 110.0% Does not comply.
Remarks:- The sample is of “Substandard” quality under the Drug Act 1976.
The firm requested for Appellate Testing.
Result of NIH
The result of the NIH on the basis of which sample under reference has been declared sub- standard are reproduced as follows:-
Description:-
“Yellow coloured liquid contained in amber coloured plastic bottle having jelly like masses. Some salts are also accumulated around cap on neck of the bottle. The bottle is further packed in an outer carton. (Does not comply with official Pharmacopeia which states that “physical and chemical properties are retained through the shelf life of a pharmaceutical product”.
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Assay:- Complies with alternate specification Biosynth Pharma Rrawalpindi.
(found 1.217g/5 ml, stated 1.25g/5 ml), (%age 97.36, limit 90-110 %)
Conclusion:- The sample is of “Substandard” quality on the basis of test performed.
Remarks:- (By The Appellatte Lab.) “Manufacturer failed to provide thae specification for the test and analysis of “Alkalizer Syrup” therefore alternate specification of Biosynth Pharma was followed in this regard.”
As per procedure show cause notices was issued to the firm and offering opportunity of personal hearing before the Drug Registration Board.
Mr. Munawar Shaid Bhatti S/o Yasin Shahid Bhatti, appeared before the Board and pleaded the case in its 257th meeting of Registration Board held on 24th & 25th March 2016 on behalf of M/s Drug Pharm Lahore.
Decision: Registration Board after detailed discussion, deliberation, considering the facts and legal provision decided to suspend registration of Alakalizer Syrup, M/s Drug Pharm (Pvt) Ltd, Lahore for six months (06) and to conduct the PSI from the following panel:-
i. Mr. Saleem Butt, (Director DTL), ii. Area FID. iii. ADC, Lahore.
Case No.02 Manufacture and Sale of Substandard Drug-Fenaclod Injection (Diclofenac Sodium) Batch No.020 By M/s Epoch Pharmaceuticals, Karachi. No.F.3- 27/2014-(QC)
The Sample of Fenaclod Injection Batch No.020, manufactured by M/s Epoch Pharmaceuticals, Karachi, taken by FID Islamabad from the premises of Federal Government Dispensary, FIA Headquarter, G-8/1, Islamabad on 13-03-2014 was declared substandard, on the basis of pH, by Federal Government Analyst, CDL Karachi vide Test Report No. IP.88/2014 dated 16th April 2014. The result of the CDL report on the basis of which the sample under reference has been declared sub-standard are reproduced as under:-
pH Determined 7.64
Limits 8.1 to 8.8 Does not comply.
Remarks:- The sample is of “Sub-Standard” quality under the Drug Act 1976.
Note:- (by the CDL , Karachi) The previous sample bearing the same batch number (020) of the same product , same manufacturer and registration number (050475), referred by FID Karachi was reported as “standard” quality on 07,April 2014 vide CDL report No.CHE.02/2014.
Minutes for 257th Registration Board Meeting 365
The concerned FID Islamabad was asked to submit the complete case along with names of the responsible persons. The FID submitted the case by forwarding the reply of the firm and names of MD, Production Manager and Quality Control Manager. As per procedure show cause notices was issued to the firm and offering opportunity of personal hearing before the Drug Registration Board.
In the reply of the show cause notice to the firm has raised some objections regarding chain of sale (manufacturer bill warranty) manufacturer portion and claim of the standard quality by the CDL Karachi same batch referred by FID Karachi.
No representatives of M/s Epoch Pharmaceuticals Karachi was appeared before the Board in its 257th meeting of Registration Board held on 24th & 25th March 2016.
Decision: Deferred the case for last opportunity to the M/s Epoch Pharmaceuticals Karachi if they want to avail personal hearing before the Board in the Registration Board. In case of failure of the firm to appear before the Board in its next meeting of Registration Board, the Board will take ex-parte decision.
Case No.03 Manufacture & Sale of Substandard Drug-Injection Finaxon 1g, (Ceftriaxone Sodium) Batch No. F-SI-261 By M/s Farmaceutics International, Karachi F. No. 03-62/2013-QC
The sample of Finaxon 1g, Injection Batch No. F-SI-261 By M/s Farmaceutics International, Karachi drawn by FID Karachi from manufacturing premises for test/analysis on 01-10-2013, was declared Substandard vide CDL’s test report No.843/2013 dated 27th November 2013 by the Federal Government Analyst, CDL, Karachi.
Assay for Determined amount/vial Statedamount/vial Percentage
Ceftriaxone 0.77175 gm 1.0gm 77.175%
Limits:- 90.0% to 115.0% Does Not Comply.
Note:- Weight of the powder in vial is 0.8862g instead of 1.1g
Remarks:- The sample is of “Sub-Standard” quality under the Drug Act 1976.
An explanation letter was issued to the manufacturer by the FID, on 05-12-2013 In response of explanation by the FID the manufacturer has submitted their reply whereby they had requested for re-test of batch in question vide letter No. Nil dated 21st January 2014 received in FID office on 22nd January 2014. The concerned FID Karachi has ascertained vide her letter
Minutes for 257th Registration Board Meeting 366 dated 11-08-2014 that the reply of the firm was received after the due specified date which may not be maintained in the eyes of law.
The request of the firm for retesting is time barred as per Drug Act 1976.
The FID had concluded that the firm M/s Farmaceutics International, Karachi is involved in the manufacturing and selling of the subject cited substandard drug and has violated Section 23(1)(a)(v) of Drugs Act 1976. Following recommendations has been made by the FID
i. Permission for prosecution in Drug Court Sindh, Karachi may be issued against the responsible persons. ii. The case may be considered for cancellation of registration of the drug i.e. Injection Finaxon 1g, Reg. No. 042409.
The FID had submitted the following responsible persons are as under:-
i. M/s Farmaceutics International, Karachi ii. Mr. Muhammad Anis, (Proprietor/owner), iii. Madam Sidra Sajid (Production Incharge), iv. Miss Shazia Perveen (Quality Control Incharge)
As per procedure show cause notices was issued to the firm and above named accused persons, offering opportunity of personal hearing before the Drug Registration Board.
Mr. Jameel Hussain Qureshi Advocate High Court Islamabad presented before the Board on behalf of M/s Farmaceutics International Karachi and pleaded the case
Decision: Registration Board after detailed discussion, deliberation, considering the facts and legal provision decided to suspend registration of Injection Finaxon 1g, (Ceftriaxone Sodium), M/s Farmaceutics International, Karachi for six months (06) and to conduct the PSI from the following panel:- i. Dr. Abdur Rashid, Chairman, Quality Control, DRAP, Islamabad. ii. Director DTL, Karachi. iii. Area FID
Minutes for 257th Registration Board Meeting 367
Case No.04 Manufacture and Sale of Substandard Manadol Suspension (Paracetamol) Batch No. 4MD-005 Manufactured by M/s Masfa Industries (Pvt) Ltd Lahore. F.No.3-52/2014-(QC)
It is submitted that the samples of Manadol Suspension (Paracetamol) Batch No. 4MD- 005, Manufactured by M/s Masfa Industrieis (Pvt) Ltd, Lahore drawn by FID- (L-III) Lahore from manufacture premises on 10-09-2014, was declared Substandard on the basis of assay vide Test Report No.LHR.230/2014. dated 02-10-2014 by Federal Government Analyst.
Assay for Determined amount/5ml Statedamount/5ml Percentage
Paracetamol 84.188 mg 120.0mg 70.15% Limits:- 95.0% to 105.0% Does Not Comply.
Remarks:- The sample is of “Sub-Standard” quality under the Drug Act 1976.
On the explanation of FID to the firm the firm has made request for Appellate testing to FID. The Appellate Laboratory tested the sample and declared the substandard on the basis of assay.
Assay for Statedamount/5ml Found Percentage
Paracetamol 120mg/5ml 65.64mg/5ml 54.7%
Limits:- 95.0% to 105.0% Does Not Comply BP 2011
Description:- Pink coloured suspension contained in amber cloured glass bottle having undissolved solid masses which do not disperse even on shaking. (Does not comply with BP-2011 which states that suspension may show a sediment which is readily dispersed on shaking”
Remarks:- The sample is of “Sub-Standard” on the basis of tests performed. The firm has violated the Section 23(1)(a)(v) of the Drugs Act 1976, however the names of the following persons of the firm have been furnished by the FID.
i. M/s Masfa Industrieis (Pvt) Ltd .Lahore, ii. Mr. Mian Muhammad Ghani, (Chief Executive), iii. Mr. Hafiz Abud Bakar (Production Manager) iv. Mr. Hafiz Murtaza (Quality Control Manager)
As per procedure show cause notices was issued to the firm and above named accused persons, offering opportunity of personal hearing before the Drug Registration Board.
In the reply of the show cause notice the firm informed that they have tested own and some other authentic laboratories the most results shown as standard quality. They further stated that they have never been contravened before this. The firm further stated that this is first time so
Minutes for 257th Registration Board Meeting 368
requested to give a chance. The firm has attached some copies of CDL and Provincial Laboratories tests reports of other batches or other products.
Mr. Mian Muhammad Ghani CEO, of the firm and Mr. Hafiz Abu Bakar, Production Manager, of the M/s Masfa Industries Pvt Ltd Lahore, appeared before the Board and pleaded their case.
Decision: Registration Board after detailed discussion, deliberation, considering the facts and legal provision decided to suspend registration of Manadol Suspension (Paracetamol), M/s Masfa Industries (Pvt) Ltd Lahore for six months (06) and to conduct the PSI from the following panel:- i. Director DTL Punjab, Lahore. ii. Area FID iii. ADC, Lahore
Case No.05 Manufacture and Sale of Substandard “Surgeon Cotton Bandage, Batch No. 413, By M/s Hafiz Pharma Industry, Distt. Gujranwala. F. No. 03-37/2015-QC . The sample of Surgeon Cotton Bandage, Batch No.413 Manufactured by M/s Hafiz Pharma Industry, Distt. Gujranwala, drawn by FID Lahore-I from manufacturing premises on 09-03-2015, was declared Substandard on the basis of specifications vide CDL’s test report No.LHR.46/2015 dated 13th May 2015.
Threads per stated length:- Determined: Limits
Weft 9.97/cm 10.45 to 10.95/cm Does not comply
Weight per Unit Area 81.62gm/m2 68.5 to 73.5 Does not comply
On explanation letter and reminders was issued to the manufacturer by the FID, on 11-03-2015, 31-07-2015 and 18-08-2015 to stop the distribution of the same batches, recall the said drugs, provide the names of the responsible persons and explain the position in this regard but firm had not reply to the FID letters and reminders.The manufacturer had submitted their reply vide letter No. Nil dated 28-07-2015 received in FID office on 19-08-2015, whereby they requested for re- test of batches in question.
The request of the retesting of the product is time barred under the Drug Act 1976.
The names of the following persons of the firm had been furnished by the FID:-
i. M/s Hafiz Pharma Industry, Distt. Gujranwala ii. Mr. Hafiz Abdul Rehman, (M.D), iii. Dr.Muhammad Azeem (Production Manager), iv. Hameed Gul (Quality Control Manager)
Minutes for 257th Registration Board Meeting 369
As per procedure show cause notices was issued to the firm and above named accused persons, offering opportunity of personal hearing before the Drug Registration Board. They have been also called for personal hearing.
Mr. Hafiz Abdul Rehman Managing Director, of the firm and Mr. Waleed Akhtar representative of the M/s Hafiz Pharma Kamonki Gujranwala appeared before the Board and pleaded their case. Decision: Registration Board after detailed discussion, deliberation, considering the facts and legal provision decided to issue the warning to the M/s Hafiz Pharma Kamonki Gujranwala
Case No. 06 Manufacture and Sale of Substandard “Surgeon Cotton Crepe Bandage B.P.C, Batch No. 414, By M/s Hafiz Pharma Industry, Distt. Gujranwala. F. No. 03-38/2015-QC
The sample of Surgeon Cotton Crepe Bandage, B.P.C, Batch No.414 Manufactured by M/s Hafiz Pharma Industry, Distt. Gujranwala, drawn by FID Lahore-I from manufacturing premises on 09-03-2015, was declared Substandard on the basis of specifications vide CDL’s test report No.LHR.48/2015 dated 13th May 2015.
Determined: Limits
Wrap: 14.96/cm Not less than 17.0/cm Does not comply Weft 73.49/10cm Not less than 78.0/10cm Does not comply
On explanation letter and reminders was issued to the manufacturer by the FID, on 11- 03-2015, 31-07-2015 and 18-08-2015 to stop the distribution of the same batches, recall the said drugs, provide the names of the responsible persons and explain the position in this regard but firm had not reply to the FID letters and reminders. The manufacturer had submitted thier reply vide letter No. Nil dated 28-07-2015 received in FID office on 19-08-2015 whereby they requested for re-test of batches in question.
The request of the retesting of the product is time barred under the Drug Act 1976.
The names of the following persons of the firm have been furnished by the FID:-
i. M/s Hafiz Pharma Industry, Distt. Gujranwala ii. Mr. Hafiz Abdul Rehman, (M.D), iii. Dr.Muhammad Azeem (Production Manager), iv. Hameed Gul (Quality Control Manager)
As per procedure show cause notices was issued to the firm and above named accused persons, offering opportunity of personal hearing before the Drug Registration Board. They have been also called for personal hearing.
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Mr. Hafiz Abdul Rehman Managing Director, of the firm and Mr. Waleed Akhtar representative of the M/s Hafiz Pharma Kamonki Gujranwala appeared before the Board and pleaded their case.
Decision: Registration Board after detailed discussion, deliberation, considering the facts and legal provision decided to issue the warning to the M/s Hafiz Pharma Kamonki Gujranwala.
Case No.07 Manufacture and Sale of Substandard “Surgeon Gauze Roll B.P.C, Batch No. 393, By M/s Hafiz Pharma Industry, Distt. Gujranwala. F. No. 03- 36/2015-QC
The sample of Surgeon Gauze Roll B.P.C, Batch No.393 Manufactured by M/s Hafiz Pharma Industry, Distt. Gujranwala, drawn by FID Lahore-I from manufacturing premises on 09-03-2015, was declared Substandard on the basis of specifications vide CDL’s test report No.LHR.47/2015 dated 13th May 2015.
Threads per stated length:- Determined: Limits
Weft 52.48/10cm 55.67 to 58.33/10cmDoes not comply
Weight per Unit Area 18.35gm/m2 14.67 to 15.33gm/m2 Does not comply
On explanation letter and reminders was issued to the manufacturer by the FID, on 11- 03-2015, 31-07-2015 and 18-08-2015 to stop the distribution of the same batches, recall the said drugs, provide the names of the responsible persons and explain the position in this regard but firm had not reply to the FID letters and reminders. The manufacturer had submitted their reply vide letter No. Nil dated 28-07-2015 received in FID office on 19-08-2015, whereby they requested for re-test of batch in question.
The request of the retesting of the product is time barred under the Drug Act 1976.
The names of the following persons of the firm have been furnished by the FID along with its report:-
i. M/s Hafiz Pharma Industry, Distt. Gujranwala ii. Mr. Hafiz Abdul Rehman, (M.D), iii. Dr.Muhammad Azeem (Production Manager), iv. Hameed Gul (Quality Control Manager)
As per procedure show cause notices was issued to the firm and above named accused persons, offering opportunity of personal hearing before the Drug Registration Board. They have been also called for personal hearing.
Mr. Hafiz Abdul Rehman Managing Director, of the firm and Mr. Waleed Akhtar representative of the M/s Hafiz Pharma Kamonki Gujranwala appeared before the Board and pleaded their case.
Minutes for 257th Registration Board Meeting 371
Decision: Registration Board after detailed discussion, deliberation, considering the facts and legal provision decided to issue the warning to the M/s Hafiz Pharma Kamonki Gujranwala.
Case No.08 Manufacture and Sale of Substandard “Febrisol Suspension Paracetamol Batch No. 1506 By M/s Redex Pharmaceutical Pvt Ltd Faisalabad. No.F.3-35/2015-(QC)
The sample of Febrisol Suspension Batch No.1506, M/s Redex Pharmaceuticals (Pvt) Ltd Faisalabad. The FID Faisalabad at Lahore draw the sample from manufacturing premises on 14- 05-2015, for the test/analysis. However the sample was declared Substandard vide CDL’s test report No.LHR.115/2015 dated 13th January 2015 by Federal Government Analyst, CDL, Karachi.
Assay for Determined amount/5ml Statedamount/5ml Percentage
Paracetamol 84.96 mg 120.0mg 70.80%
Limits:- 90.0% to 110.0% Does Not Comply.
Remarks:- The sample is of “Substandard” quality under the Drug Act 1976
On explanation letter issued by the FID, the firm challenged the CDL report and requested for Appellate Testing under Section 22(5) of Drugs Act, 1976.
The Appellate Laboratory has also declared the sample as Substandard vide their test report 023-MNHRS/2015 dated 07th October 2015.
Assay for Stated amount Found Percentage
Paracetamol 120mg/5ml 90.214mg/5ml 75.178%
Limits:- 95.0% to 105.0% Does Not Comply with BP 2013
Volume Determined Limit 50ml 60ml Does not comply with volume stated on the label
Remarks:- The sample is of “Substandard” quality on the basis of tests performed
The names of the following persons of the firm have been furnished by the FID along with its report.
i. M/s Redex Pharmaceuticals (Pvt.) Ltd, Faisalabad ii. Mr. Muhammad Ashfaq, (Chief Executive),
Minutes for 257th Registration Board Meeting 372
iii. Mr. Deedar Ali (Production Manager Manager), iv. Ms. Sadia Ashraf (Quality Control)
As per procedure show cause notices was issued to the firm and above named accused persons, offering opportunity of personal hearing before the Drug Registration Board. They have been also called for personal hearing.
No representatives of M/s Redex Pharmaceuticals Faisalabad was appeared before the Board in its 257th meeting of Registration Board held on 24th & 25th March 2016.
Decision: Deferred the case for last opportunity to the M/s Redex Pharmaceutical Pvt Ltd Faisalabad if they want to avail personal hearing before the Board in the Registration Board. In case of failure of the firm to appear before the Board in its next meeting of Registration Board, the Board will take ex-parte decision
Case No.09. Manufacture & Sale of Sub-Standard Drug- Kohinoor Wove Bandage BP Type-2 Batch No. 2103309 By M/S Kohinoor Industries, Sahiwal.
The sample of Kohinoor Open Wove Bandage BP Type-2 Batch No. 2103309, Manufactured by M/s Kohinoor Industries 159-160/B Industrial Estate Sahiwal, drawn by FID-III Lahore from manufacturing premises on 18-09-2015, The Federal Government Analyst CDL Karachi vide test report No.LHR. 306/2015 dated 10th November 2015 has declared the sample of Kohinoor Wove Bandage BP Type-2 Batch No. 2103309 By M/S Kohinoor Industries, Sahiwal, as of “Substandard Quality”. The names of the following persons of the firm have been furnished by the FID along with its report.
i. M/S Kohinoor Industries, Sahiwal, ii. Mr. Shiekh Haroon Shahid, (Managing Director ), iii. Mr. Naveed Iqbal Abid (Quality Control Manager), iv. Mr.Abdul Star (Production Manager)
As per procedure show cause notices was issued to the firm and above named accused persons, offering opportunity of personal hearing before the Drug Registration Board.
In reply to the show cause notice to the M/s Kohinoor Industries, Sahiwal the firm take the stance that the size, length & width have relaxation according to the notification no.F.6-6/2005- Reg-II (South) dated 13th September 2006. The firm stated that By Calculation accordingly to 5% they comply comply the specifications as they mentioned on the label.
Decision: Registration Board after detailed discussion, deliberation, considering the facts and legal provision decided to drop the case in light of Notification vide Reference No. F.6-6/2005-Reg-II (South)
Minutes for 257th Registration Board Meeting 373
Case No.10 Manufacture & Sale of Sub-Standard Drug-CK Quin 500 (Levofloxacin) Batch No.T-5105 by M/S CKD Pharmaceutical, Pakistan (Pvt) Ltd Karachi F. No. 3-05/2016-QC
The FID Karachi inspected the premises of M/s CKD pharmaceuticals (Pvt) Ltd Korangi Industrial area Karachi and took the sample of CK Quin 500mg Batch No.T-5105 by M/s CKD Pharmaceutical Pakistan Pvt Ltd Karachi for test/analysis. However the sample was sent to the Federal Government Analyst, CDL, Karachi. The CDL Karachi vide its test report No.R.KQ.360/2015 dated 22nd December 2015 declared the Substandard. The result of CDL on the basis of which sample under reference has been declared sub-standard are reproduced as under:-
Sub-Standard with regard to Dissolution Test.
Stage-1
Tablet No. (%)age 01. 47.66 02. 57.43 03. 50.92 04 48.55 05. 54.41 06 52.70
Limits for (Stage-1):- Each unit is not less than Q+5% i.e. 80+5=85% Stage-2
Tablet No. (%)age 01. 54.53 02. 49.54 03. 43.09 04 53.65 05. 54.23 06 56.29
Average of 12 units= 623/12=51.91%
Limits for (Stage-2):- Average of 12 unit (S1+S2) is equal to or greater than Q (75%) and no unit is less than Q-15% (75-15=60%)
Limits for (stage-3):- Average of 24 units (S1+S2+S3)is equal to or greater than Q (80%) not more than 2 Units are less than Q-15 (80-15=65%) & no unit is less than Q-25% (80- 25=55%)
Since, all the 12 tablets are below 65% and 10 tablets are already below 55% therefore, the sample Does not comply USP 37
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Remarks:- The sample is of “Sub-Standard” quality under the Drug Act 1976.
The names of the following persons of the firm have been furnished by the FID Karachi.
i. M/S CKD Pharmaceutical, Pakistan (Pvt) Ltd Karachi. ii. Anas Sultan Ahmed, (Managing Director), iii. Meval Das Kukreja (ProductionManager), iv. Mukashaf Ameen (Quality Control Incharge) v. Muhammad Arif Saleem (Quality Control Manager)
The Fid recommended for immediate consideration under section 7 (11) (d) and action under section 41 and /or section 42 of the drugs Act 1976.
As per procedure show cause notices was issued to the firm and above named accused persons, offering opportunity of personal hearing before the Drug Registration Board.
In reply the firm stated that the drug was never marketed and the said complete batch is still in their stock. Hence recall is not needed. The firm further stated that have retested the said batch and found the result to be in limit. The firm has requested for retesting from the appellate Laboratory.
Decision: Registration Board discussed that under Section 22(5) has discretion to extend the time period but every discretion should be exercised judiciously, therefore with cogent reason the firm is called for personal hearing
Case No.11: Manufacture & Sale of Sub-Standard Drug-Clorazine 100 mg (Chlorpromazine HCl) Batch No.T-5035 by M/S CKD Pharmaceutical, Pakistan (Pvt) Ltd Karachi.
FID Karachi inspected the premises of M/s CKD pharmaceuticals (Pvt) Ltd Korangi Industrial area Karachi and took the sample of Clorazine 100 mg Batch No.T-5035 by M/s CKD Pharmaceutical Pakistan Pvt Ltd Karachi for test/analysis. However the sample was sent to the Federal Government Analyst, CDL, Karachi. The CDL Karachi vide its test report No.R.KQ.365/2015 dated 22nd December 2015 declared the Substandard. The result of CDL on the basis of which sample under reference has been declared sub-standard are reproduced as under:- Sub-Standard with regard to Dissolution Test. Stage-1 Tablet No. (%)age 01. 66.704 02. 95.379 03. 90.949 04 63.750 05. 96.856 06 113.347
Minutes for 257th Registration Board Meeting 375
Limits for (Stage-1):- Each unit is not less than Q+5% i.e. 75+5=80% Stage-2
Tablet No. (%)age 01. 112.978 02. 29.168 03. 49.843 04 103.502 05. 123.685 06 32.737
Average of 12 units= 978.898/12=81.574%
Limits for (Stage-2):- Average of 12 unit (S1+S2) is equal to or greater than Q (75%) and no unit is less than Q-15% (75-15=60%)
Limits for (stage-3):- Average of 24 units (S1+S2+S3)is equal to or greater than Q (75%) Not more than 2 Units are less than Q-15 (75-15=60%) & no unit is less than Q-25% (75- 25=50%)
Since, 03 tablets are below 60% and 01 tablet is already below 50% therefore, the sample Does not comply
Remarks:- The sample is of “Sub-Standard” quality under the Drug Act 1976.
The names of the following persons of the firm have been furnished by the FID Karachi. i. M/S CKD Pharmaceutical, Pakistan (Pvt) Ltd Karachi. ii. Anas Sultan Ahmed, (Managing Director), iii. Meval Das Kukreja (ProductionManager), iv. Mukashaf Ameen (Quality Control Incharge) v. Muhammad Arif Saleem (Quality Control Manager)
The Fid recommended for immediate consideration under section 7 (11) (d) and action under section 41 and /or section 42 of the drugs Act 1976.
As per procedure show cause notices was issued to the firm and above named accused persons, offering opportunity of personal hearing before the Drug Registration Board.
In reply the firm stated that the drug was never marketed and the said almost complete batch is still in their stock. Hence recall is not needed. The firm further stated that have retested the said batch (T- 5035) and found the result to be in limit. The firm has requested for retesting from the appellate Laboratory.
Decision: Registration Board discussed that under Section 22(5) has discretion to extend the time period but every discretion should be exercised judiciously, therefore with cogent reason the firm is called for personal hearing.
Minutes for 257th Registration Board Meeting 376
Additional Agenda
Item No.V: Cases referred by Pharmaceutical Evaluation & Registration Division.
RRR Section. Case No.01: Renewal of registered drugs.
Directorate of (PE&R) is dealing with number of application submitted for renewal of drugs which are incomplete or have shortcoming especially with reference to the submitted prescribed renewal fees. The following type of cases are encountered while processing of the application for renewal of drugs.
1. The application for renewal of Drugs is submitted on Form 5-B before the expiry of the validity of the certificate of registration but is incomplete or has shortcomings with reference to renewal application fee or having some other deficiency.
2. Application for renewal of drugs is 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 but is incomplete with reference to renewal application fee or having some other deficiency.
Above cases were referred to Divisions of Budget & Accounts and Legal Affairs fpr their comments, which are as under :-
Comments from Division of Budget & Accounts: It is a legal point whether payment of half fee before due date tantamount to payment of renewal fee or not. In the instant case remaining fee was paid after due date (more than 4 months), therefore, its states may be examined it appropriate level.
Comments from Division of Legal Affair: It is an administrative decision whether to entertain or not, these types of cases. Concerned division will have to decide the same
Rules position for the application for the renewal of drugs:
Rule 26 [(3-A)] of the (Drug (Licensing, Registering & Advertising) Rules, 1976 states that “Application for renewal of registration of a drug shall be made in form 5 –B “and
Rule [(3-B) An application under sub-rule (1) or sub-rule (3) shall be accompanied by the proper fee the specified in schedule ‘F’.
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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.
Decision: Registration Board deliberated the case and decided that any application submitted either during valid registration time or within 60 days of expiry but with incomplete documents and/or fee will be considered by Registration Board subject to completeion of shortcomings including fee. Moreover, validity of registration period will be considered from initial date of registration.
Case No.02: Cases for renewal of registered drugs with shortcomings.
a. M/s Pharmatec Pakistan (Pvt) Ltd Karachi
S. Reg/No Name of Products. Initial date of Application receiving Renewal No Registration date status . And fee submitted date 1 057951 Ezomol 20 mg capsule 31-07-2009 Rs 10,000 on Validity of Each capsule contains 07-07-2014 and later registration Esomeprazole (as on submitted will have be magnesium Trihydrate Rs10,000/-on discussed enteric coated pellets 22-12-2014 equivalent to Esomeprazole…… 20 mg 2 057952 Ezomol 40 mg capsule do do do Each capsule contains Esomeprazole (as magnesium Trihydrate enteric coated pellets equivalent to
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Esomeprazole……40 mg
Decision: Firm submitted renewal application within valid registration time (07-07- 2014) but with less fee as required for imported pellets. Later on, firm deposited remaining fee Rs.10000/- on 22.12.2014. Keeping in view decision of Registration Board, renewal of above products will be considered valid till 30.07.2019.
b. M/s Noa Hemis Pharma Karachi.
S.No. Reg/No Name of Products Initial date of Application Renewal status registration Receiving Date And fee submitted date 1 058623 Acifre 20 mg 10-10-2009 29-08-2014 Validity of capsule Rs.10,000/-and registration will Each capsule Later on have to be contains submitted discussed Esomeprazole (as Rs.10,000/-on magnesium 21-1-2015 Trihydrate enteric enteric coated pellets eq. to Esomeprazole…… 20 mg 2 058624 Acifre –D 40 mg do do do capsule Each capsule contains Esomeprazole (as magnesium Trihyd enteric coated pellets eq. to Esomeprazole…… 40 mg
Decision: Firm submitted renewal application within valid registration time (29-08- 2014) but with less fee as required for imported pellets. Later on, firm deposited remaining fee Rs.10000/- on 21-01-2015. Keeping in view decision of Registration Board, renewal of above products will be considered valid till 09.10.2019.
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c. M/s Mediate Pharma Karachi
S. Reg/No. Product/Name Initial date of Application Application No registration due on receiving date 1 008952 Diazomil tablet 09-3-2004 08-03-2014 12-03-2014 Each tablet contains Remaining fee Diazepam…..5mg 21-01-2016
2 009354 Phenobarbitone tablet 09-03-2004 12-03-2014 Each tablet contains Remaining fee Phenobarbitone….30 21-01-2016 mg
Decision: Firm submitted renewal application within 60 days of expiry period of registration time (12-03-2014) but with less fee. Later on, firm deposited remaining fee Rs.10000/- on 21-01-2016. Keeping in view decision of Registration Board, renewal of above products will be considered valid till 08.03.2019.
d. Epoch Pharmacreuticals, Karachi S. Reg/No. Product/Name Initial date of Application Application No registration due on receiving date 1 048597 RSV tablet 10.05.2008 09.05.2013 14-05-2013 Each tablet contains (5 days later) Ribavirin…..400 mg Remaining fee 22-03-2016
2 048598 RSV tablet 10.05.2008 09.05.2013 Do Each tablet contains Ribavirin…..600 mg
Decision: Firm submitted renewal application within 60 days of expiry period of registration time (14-05-2013) but with less fee. Later on, firm deposited remaining fee Rs.10000/- on 22-03-2016. Keeping in view decision of Registration Board, renewal of above products will be considered valid till 09.05.2018.
Case No.03: Renewal of registered drugs received within 60 days of expiry period:
M/s Well & Well Pharma Islamabad has applied for renewal of following products with detail as under: S. Reg/No Products/Name Initial date of Application Application No. registration due on receiving date. 1 065132 Musrel 2 mg tablet 22-07-2010 21-07-2015 24-08-2015 Each tablet contains Approximate Tizanidine (as (with 33 days)
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hydrochloride)…….. Fee Rs 20,000 2mg (USP Specification) 2 065133 Musrel 4 mg tablet do do d Each tablet contains Tizanidine (as hydrochloride)…….. 4mg (USP Specification)
Decision: Firm submitted renewal application within 60 days of expiry period of registration time (24-08-2015) with requisite fee. Thus renewal of above products will be considered valid till 21.07.2020.
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Case No.04: Data authenticity for New Chemical Entities / New Drugs and subsequent me too drugs
Registration Board in 256th meeting considered the applications of following firms and constituted a three members panel to investigate the authenticity/genuineness of data (import of raw material and stability data submitted for registration). The composition of panel is as follows:- a). Brig.(R) Dr.Muzammil H.Najmi Chairman b). Dr.Saif-ur-Rehman Khattak, FGA,CDL,Karachi Member c). Dr.Obaidullah, DDG(R.I), DRAP Member/Secretary
Panel was advised vide letter No. F.1-3/2016-DDG (R-I) dated: 14-03-2016 to conduct inspection of the following firms as per decision of Registration Board and submit report for further consideration:-
Registration S.# Name of manufacturer Detail of product Board Meeting 1. M/s. S. J. & G. FazulEllahie, Novus (Sofosbuvir 400mg) Tablets 255th Karachi 2. M/s PharmEvo Pharmaceuticals, Zoval (Sofosbuvir 400mg) Tablets 256th Karachi
Scope of investigation:
Investigation of the authenticity / genuineness of data (import of raw material and stability data), manufacturing of stability batches and stability studies on these batches.
Tools for Investigation:
The investigation was conducted by using a structured questionnaire. Objective evidence was done via physical inspection of the facilities for manufacturing and quality control, material used and retained, personnel involved, ongoing studies, printed data and integrity and security of data in respective databases. Company wise detailed report is as follows:
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1. M/s.S. J. & G. Fazul Ellahie, Novus (Sofosbuvir 400mg) Tablets 255th Karachi Registration Board Meeting
Investigation Date and Time: 17th March, 2015
Q.No. Question Observation by panel
1. Do you have documents confirming the The Firm has imported 600g API import of sofosbuvir API? (sofosbuvir) from M/s Virupuksha, India. Firm has no approval from DRAP for import. However, firm informed that they applied for permission for clearance of material at DRAP, Karachi and Islamabad but permission was not granted. 2. What was the rationale behind selecting The rationale behind selecting the the particular manufacturer of API? manufacturer is its GMP Status only. 3. Do you have documents confirming the Firm has imported sofosbuvir working import of sofosbuvir reference standard standard. However, firm has now and impurity standards? imported impurity standards but still not used for analysis purpose. 4. Do you have certificate of Analysis of the The firm has certificate of analysis for the API, reference standards and impurity API, working standard and impurity standards? standard. 5. Do you have any approval of API or The firm has GMP certificate of API GMP certificate of API manufacturer manufacturer issued by regularity issued by regulatory authority of country authority of country of Origin. of origin? 6. Do you use API manufacturer method of The firm has method of analysis of API testing? manufacturer 7. Do you have stability studies reports on The firm has stability studies reports on API? API provided by API manufacturer 8. If yes, whether the stability testing has The stability testing has been performed been performed as per SIM method and on API by manufacturer as per SIM degradation products have been method and degradation products have quantified? been quantified. 9. Do you have method for quantifying the Firm has method for quantifying impurities in the API? impurities in API but not used for this purpose. 10. Do you have some remaining quantities The firm has some remaining quantities of the API, its reference standard and of the API and working standard. impurities standards? Impurities standards have not been used yet.
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11. Have you used pharmaceutical grade The firm has used pharmaceutical grade excipients? excipients. 12. Do you have documents confirming the Import documents for some of the import of the used excipients? excipients are available however some excipients are lacking for the import documents i.e. they are purchased from the local markets. 13. Do you have test reports and other records The firm has test reports on certain on the excipients used? quality parameters of the some of the excipients used. 14. Do you have written and authorized The firm has method for manufacturing of protocols for the development of the sofosbuvir tablets along with written sofosbuvir tablets? and authorized protocols for the development of sofosbuvir tablets. 15. Have you performed Drug-excipient The firm has not performed Drug- compatibility studies? excipient compatibility studies because the composition of their tablets is similar to that of the innovator product (Sovaldi Tablet). 16. Have you performed comparative The firm has performed comparative dissolution studies? dissolution studies with Sofohil(Sofosbuvir 400mg) tablets, Hilton Pharmaceutical, Karachi by using HPLC method. 17. Do you have product development (R&D) The firm has partial product development section (R&D) section (mixing, compression and coating) and used general area for blistering. 18. Do you have necessary equipments Mixer, compression and coating available available in product development section for development of sofosbuvir tablets? 19. Are the equipments in product The production equipments in product development section qualified? development section are not qualified.
20. Do you have proper maintenance / Calibration record is available. However calibration / re-qualification program for proper maintenance program was not the equipment used in PD section? available 21. Do you have qualified staff in product The firm has specified staff in product development section with proper development. knowledge and training in product development?
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22. Have you manufactured three stability The firm has manufactured three stability batches for the stability studies of batches for the stability studies of sofosbuvir tablets as required? sofosbuvir tablet as follows: Batch number TR013-15, 250 tablets Batch number TR015-15, 500 tablets Batch number TR019-15, 500tablets 23. What was the criteria for fixing the batch As per statement of the firm the criteria size of stability batches? for fixing the batch size of stability batches is the number of tablets per testing frequency 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 as per their batch manufacturing record and equipment log books. 25. Do you have protocols for stability testing The firm has methods for stability testing of stability batches? of stability batches. 26. Do you have developed and validated the The firm has developed and validated the method for testing of stability batches? method of testing for testing stability batches however the method has no capability to separate and quantify the impurities in the tablets being manufactured by the firm. 27. Do you have method transfer studies in Not Applicable case when the method of testing being used by your firm is given by any other lab? 28. Do you have documents confirming the Only HPLC used in the test and analysis qualification of equipments / instruments of sofosbuvir API and the finished drug is being used in the test and analysis of qualified. sofosbuvir API and the finished drug?
29. Do your method of analysis stability The firm’s method of analysis of stability indicating? batches is not stability indicating, therefore degradation products have not been quantified in accelerated and real time stability studies. However quantification of the active ingredient has been done at every testing point. The analysis records also show that there are significant variations (out of acceptable limits) for dissolution test, intra batch and inter batches at various testing points both in accelerated and real time stability studies. For example,
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For batch no TR-013-15, in accelerated stability study the intra batch dissolution test variations are with RSD > 10% whereas these variations are with RSD> 9% in real time studies . For batch no TR-015-15, in accelerated stability study the intra batch dissolution test variations are within limits whereas these variations are with RSD> 10% in real time studies. For batch no TR-019-15, in accelerated stability study the intra batch dissolution test variations are with RSD > 8.5% whereas these variations are within limits in real time studies. These results show that the stability batches were not manufactured properly and under controlled conditions. 30. Do your HPLC software is 21CFR HPLC software (Empower) being used by compliant? the firm is 21CFR Compliant.
31. Can you show Audit Trail reports on Firm was unable to show Audit trail on sofosbuvir testing? the testing reports.
32. Do you have some remaining quantities The firm has remaining quantities of of degradation products and stability stability batches. However there is no batches? quantity of degradation products. 33. Do you have commitment batches kept on The firm has three commitment batches stability testing? kept on stability testing for real time stability testing. 34. Do you have valid calibration status for The firm has valid calibration status for the equipments used in sofosbuvir tablets the equipment used in sofosbuvir tablets production in analysis? production and analysis however traceability to the primary standard cannot be established.
Conclusions: Based on the risk based approach it is concluded that the data submitted for registration of Novus (Sofosbuvir 400mg) Tablets is not adequate and not of required quality. However the data provided by the firm is verifiable by the record and evidence available at the premises is up to satisfactory level.
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2. M/s. PharmEvo Zoval (Sofosbuvir 400mg) Tablets 256th Pharmaceuticals, Karachi Registration Board Meeting
Investigation Date and Time: 18th March, 2015
Q.No. Question Observation by panel
1. Do you have documents confirming the The firm has imported 500g sofosbuvir import of sofosbuvir API? API from M/s Laurus, India and firm has approval from DRAP, Karachi for import. 2. What was the rationale behind selecting There is proper vendor evaluation form the particular manufacturer of API? being implemented by the firm and the rationale behind selecting the manufacturer is its GMP Status. 3. Do you have documents confirming the The firm has the API and impurity import of sofosbuvir reference standard working standards documents confirming and impurity standards? their import. Impurity working standards were not available at time of submission of data to Registration Board and now firm is in phase of analyzing its finished product for impurities. 4. Do you have certificate of Analysis of the The firm has certificates of analysis for API, reference standards and impurity API, working standard of API and standards? impurity. 5. Do you have any approval of API or The firm has copy of GMP certificate of GMP certificate of API manufacturer API manufacturer and approval of issued by regulatory authority of country Sofosbuvir by concerned regularity of origin? authority of country of Origin.
6. Do you use API manufacturer method of The firm has used API manufacturer testing? method of testing. 7. Do you have stability studies reports on The firm has stability studies reports on API? API. 8. If yes, whether the stability testing has The stability testing has been performed been performed as per SIM method and as per SIM method and degradation degradation products have been products have been quantified. quantified? 9. Do you have method for quantifying the The firm has method for quantifying the impurities in the API? impurities in the API. 10. Do you have some remaining quantities The firm has remaining quantities of the of the API, its reference standard and reference standard and impurities impurities standards? standards however the API has been completely consumed.
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11. Have you used pharmaceutical grade The firm has used pharmaceutical grade excipients? excipients. 12. Do you have documents confirming the Import documents for some of the import of the used excipients? excipients are available. However afew excipients were purchased from local markets. 13. Do you have test reports and other records The firm has test reports and other records on the excipients used? on the excipients used. 14. Do you have written and authorized The firm has written and authorized protocols for the development of protocols for the development of sofosbuvir tablets? sofosbuvir tablets. 15. Have you performed Drug-excipient The firm has not performed Drug- compatibility studies? excipient compatibility studies as the composition of their tablets is similar to that of the innovator product (Sovaldi Tablet). 16. Have you performed comparative The firm has performed comparative dissolution studies? dissolution studies with innovator brand (Sovaldi) and their product has comparable dissolution profile. 17. Do you have product development (R&D) The firm has dedicated product section development (R&D) section. 18. Do you have necessary equipments The firm has necessary equipment available in product development section available in product development section for development of sofosbuvir tablets? for development of sofosbuvir tablets. 19. Are the equipments in product The equipment in product development development section qualified? section are qualified.
20. Do you have proper maintenance / The firm has proper maintenance / calibration / re-qualification program for calibration / re-qualification 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 product development section with proper development section with proper knowledge and training in product knowledge and training in product development? development. 22. Have you manufactured three stability The firm has manufactured three stability batches for the stability studies of batches for the stability studies of sofosbuvir tablets as required? sofosbuvir tablet with batch number 155BV-1560-01-T, 155BV-1567-02-T and 155BV-1576-03-T. Each batch has a size of 250 tablets.
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23. What was the criteria for fixing the batch As per statement of the firm the criteria size of stability batches? for fixing the batch size of stability batches is the number of tablets per testing frequency and number of testing frequencies. 24. Do you have complete record of Batch manufacturing record for 3 trial production of stability batches? batches is available. However, log books of product development area are partially available. 25. Do you have protocols for stability testing The firm has detailed protocols for of stability batches? stability testing of stability batches. 26. Do you have developed and validated the The firm has used method of testing of method for testing of stability batches? API manufacturer for stability testing of finished product. Although method is capable of identifying impurities but firm has not done impurity profiling yet in finished product. 27. Do you have method transfer studies in As for Q.No.26. case when the method of testing being used by your firm is given by any other lab? 28. Do you have documents confirming the The firm has proper documents qualification of equipments / instruments confirming the qualification of equipment being used in the test and analysis of / instruments being used in the test and sofosbuvir API and the finished drug? analysis of sofosbuvir API and the finished drug. 29. Do your method of analysis stability The firm’s method of analysis is stability indicating? indicating. Firm has complete record of stability studies on stability batches. Log books of equipment used in analysis of API and trial batches were also checked and found properly maintained. However, the impurity and degradation profiling has not been started yet. HPLC chromatograms were secured by dates. 30. Do your HPLC software is 21CFR HPLC software is not 21CFR Compliant compliant? as per record available with the firm.
31. Can you show Audit Trail reports on Audit trail on the testing reports was not sofosbuvir testing? available.
32. Do you have some remaining quantities The firm has remaining quantities of of degradation products and stability stability batches however there is no batches? quantity of degradation products.
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33. Do you have commitment batches kept on The firm has three commitment batches stability testing? kept on stability testing for real time stability testing. 34. Do you have valid calibration status for The firm has valid calibration status for the equipments used in sofosbuvir tablets the equipment used in sofosbuvir tablets production in analysis? production and analysis.
Conclusions: On the basis of risk based approach the genuineness / authenticity of stability data submitted by the firm for registration of Zoval Tablets (Sofosbuvir 400mg) is verifiable to satisfactory level.
Decision: Registration Board decided as follows:
Keeping in view observations of panel, the Board decided to provide opportunity of personal hearing to M/s S J & G Fazul Ellahi, Karachi for explaining their position on points mentioned in inspection report.
Approved registration of Zoval (Sofosbuvir 400mg) Tablets, M/s. PharmEvo Pharmaceuticals, Karachi. Manufacturer will place first three production batches on long term stability studies through proposed shelf life and on accelerated studies for six months.
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Registration-I
Case No.05: Registration of Drugs under the Drugs Act, 1976-M/s. Nawan Laboratories Request for Correction of Formulation.
Registration Board in its 236th meeting held on 20th November, 2012 approved the registration of following veterinary drugs of M/s. Nawan Laboratories (Pvt.) Ltd; Karachi for local manufacturing as mentioned in column-I. The firm later requested to correct the formulation as per composition mentioned in column-II, as incorrect composition was inadvertently mentioned while typing the agenda and minutes of the Registration Board:- S. I II No. Name of Drug(s)/Composition Name of Drug(s)/Composition applied approved by Registration Board. by the firm/correct. 1. Colibac-SP 160 Powder Colibac-SP 160 Powder Each Kg powder contains:- Each Kg powder contains:- Penicillin Procaine.B.P…….....1.6 Kg Procaine Penicillin B.P…………16gm. Streptomycin Sulphtae B.P…...4.0 Kg Streptomycin Sulphtae B.P……..40gm. Zinc Bacitracin 10% BP Vet..10.0 Kg Zinc Bacitracin 10% B.P. Vet…100gm. Colistin Sulphate.BP………….0.4Kg Colistin Sulphate.B.P………….80MIU
2. PSB-Excel Powder. PSB-Excel Powder. Each Kg powder contains:- Each kg powder contains:- Pencillin Procaine BP………..12.0Kg Procaine Penicillin B.P…….....12gm. Streptomycin Sulphate BP…...36.0Kg Streptomycin Sulphate B.P……36gm. Zinc Bacitracin10% BP……...52.0Kg Zinc Bacitracin 10% B.P Vet…52gm. Neomycin Sulphate BP………10.0Kg Neomycin Sulphate B.P………10gm.
Licensing Directorate was requested to give opinion that the products containing Penicillin derivative along-with other veterinary API as mentioned above, can be manufactured in human section or otherwise. In reply Licensing Division has communicated that sub section 5.2 of Schedule-B of Drug (Licensing, Registering & Advertising) Rules, 1976 which, inter alia, specify that Veterinary products containing ingredients similar to those used for human health and of the same quality, can be manufactured in the same premises used for manufacture of pharmaceuticals. The firm has provided copy of inspection report dated 26-02-2011, wherein the panel has verified that the firm possesses the facilities for manufacturing penicillin Non-Sterile Dry Powder Syrup for human preparations. However, the issue that whether the formulation
Minutes for 257th Registration Board Meeting 391 containing non penicillin antibiotics / antibacterial i.e Streptomycin Sulphate, Zinc Bacitracin, Colistin Sulphate etc in combination with penicillin products can be permitted in human Penicillin Dry Powder/ Syrup section, is yet to be clarified. The case was considered in 254th meeting the Registration Board and the Board decided to defer the case for detail deliberation in the next meeting. Subsequently M/s. Nawan Laboratories (Pvt.) Ltd; Karachi vide a letter has requested to defer the case so that they will be able to submit the approval of veterinary penicillin area/section from Licensing Directorate. The case was discussed in 256th meeting of Registration Board and the Board while deferring the case to M/s. Nawan Laboratories Karachi, discussed the issue in detail and observed that in the light of above quoted rule, the veterinary products having ingredients, alone or combination, requiring dedicated area can be manufactured in dedicated areas for similar human products provided that ingredients have no contamination hazard and / or different intended use. However, case will be taken again in forthcoming meeting for more clarity. Decision: Registration Board while endorsing the above referred correction in minutes of 256th meeting, deferred the case for detail deliberation in next meeting.
Case No. 06. Registration Of Veterinary Drugs For Export Purpose.
M/s. Star Laboratories (Pvt.) Ltd, Lahore has applied for registration of the following veterinary drugs for export: - S # Name of Drug (s)/Composition. Pack Size. 1. Prazistar Tablet. As per importing Each tablet contains:- country Praziquantel (BP) ...... 20mg. requirement. Pyrantel Pamoate (BP) ....230mg. 2. Carprofen Tablet. As per importing Each tablet contains:- country Carprofen I.H.S) ...... 50mg. requirement. 3. Tilmisin Oral Solution. As per importing Each ml contains:- country Tilmicosin (as sulphate) (USP) 250mg. requirement. 4. Levozan Plus DS Suspension. As per importing Each 100ml contains:- country Levamisol HCl ...... 3gm. requirement. Oxyclozanide...... 6gm. Cobalt Sulphate ...... 764mg. 5. Diclavet Oral Solution. As per importing
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Each 100ml contains:- country Dicalzuril (BP) ...... 1gm. requirement.
The firm have deposited required fee Rs.20,000 x 6= Rs.120,000/- and submitted the following supporting documents:- i) Copy of Drug Manufacturing Licence. ii) Copy of acknowledgement of receipt of application for renewal of Drug Manufacturing Licence No.000130) (Formulation). iii) Copy of NOC for CRF. iv) Applications on Form-5. v) Copy of inspection report dated 13-06-2011 for renewal of DML, as evidence of availability of the Section. vi) Undertaking that applied registrations are exclusively for export purpose and will not be sold in Pakistan. vii) Notarized Photocopy of export order from importing country..
However the firm has not been able to provide appropriate evidence of Mee-to status of above product. The case was deferred by the Drug Registration Board in its 254th meeting for deliberation in forthcoming meeting as the firm did not provide any evidence of approval of these formulations from reference regulatory authorities. The case was again placed before the Registration Board in its 257th meeting and the Board deferred the case for detail deliberation on the products not approved by the reference countries. Decision: Registration Board advised applicants to deposit remaining fee and approval status by regulatory authority of importing country and authorized Chairman for grant of registration. Registration Board will be informed accordingly.
Case No. 07 Cancellation of registration of Elbat 250mg Tablet of M/s. Haji Medicine Co. Rawalpinid.
Registration Board in its 249th meeting held on 18-19th May, 2015 cancelled the registrations of following imported drugs of M/s. Rotexmedica Pakistan Ltd; Islamabad as the manufacturer abroad has appointed another firm (M/s. Umar Pharma, Peshawar) as their exclusive distributor:- S. No. Reg. No. Name of Products. 1. 069518 Elbat Tablets 250mg. Each tablet contains:- Flutamide………..250mg. 2. 063978 Ciazil Injection 10mg.
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Each 5ml vial contains: - Epirubicin (as HCI)….10mg. 3. 063981 Finastir Tablet. Each film coated tablet contains:- Finasteride………..5mg. 4. 063979 Ciazil Injection 50mg. Each 25vial contains: - Epirubicin (as HCI)….50mg. 5. 063976 Doxotil Injection 10mg. Each 5ml vial contains: - Doxorubicin HCI (USP)……10mg. 6. 063977 Doxotil Injection 50mg. Each 25ml vial contains: - Doxorubicin HCI (USP)……50mg. 7. 063980 Genefadrone Injection 20mg. Each 10ml vial contains: - Mitoxantrone (as HCl)….20mg. 8. 066071 Geneplex 1mg Tablets. Each tablets contains:- Anastrozole…………..1mg.
The cancellation letter for the above drugs were accordingly issued with exeption of Elbat 250mg Tablet as this drug was included in the stay order, which the Haji Medicine, a sister concern of Rotexmedica, obtained from Civil Judge, Islamabad regarding cancellation of registration of their imported drugs. The detail of this case is given in the proceeding paras. The Registration Board in the same meeting also cancelled the registrations of following imported drugs of M/s. Haji Medicine Co. Rawalpindi, a sister concern of M/s. Rotexmedica, as manufacturer abroad M/s. Genepharm S.A., Greece has informed that they would not precede to renewal / extension of term of agreement with M/s. Haji Medicine Co., Rawalpindi. Reg. No. Name of drug (s) & Composition. S.No. 1. 062201 Zymoplex 10mg Tablets. Each tablet contains:- Tamoxifen Citrate…15.2mg eq to Tamoxifen …10mg 2. 062202 Zymoplex 20mg Tablets. Each tablet contains: - Tamoxifen Citrate 30.4mg eq to Tamoxifen….20mg. 3. 062203 Bicamide Tablets. Each film coated tablet contains: - Bicalutamide ….50mg
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4. 062204 Bicamide Tablets. Each film coated tablet contains: - Bicalutamide ….150mg. 5. 062205 Femaplex Tablets. Each tablet contains: - Letrozole……………2.5mg.
However, M/s. Haji Medicine Co. obtained stay order from Civil Judge, Islamabad against the decision of Registration Board in respect of above drugs and also for Elbat Tablets 250mg, which was mentioned in the list of drugs de-registered in the name of M/s. Rotexmedica. Subsequently it was noticed that the Elbat 250mg Tablet was registered in the name of M/s. Haji Medicine Co. Rawalpindi but inadvertently included in the list of medicines registered in the name of M/s. Rotexmedica. As a result the show cause notice for cancellation of registration of this drug was also issued to M/s. Rotexmedica alongwith other drugs and the Registration Board accordingly cancelled the registration from the name of M/s. Rotexmedica. Subsequently, after dismissal of stay orders, the cancellation letter of the above drugs of M/s. Haji Medicine Co. was issued. However, the cancellation letter of the Elbat 250mg Tablet was not issued for the reason stated in above para. As per opinion of Legal Affairs Division, the show cause notice issued to M/s. Rotexmedica for cancellation of registration of Elbat 250mg Tablet is not valid notice for de-registration, hence the de-registration, if done without valid show cause notice, would not be in order.
Decision: Registration Board decided to proceed afresh in the case of Elbat 250mg Tablet by issuing fresh show cause notice to M/s. Haji Medicine Company, Rawalpindi for cancellation of registration.
Case No. 08. Change of Manufacturer/Manufacturing Site of Venofer Injection of M/s. RG Pharmaceuticals, Karachi.
M/s. RG Pharmaceuticals, Karachi had requested for change of manufacturer abroad of their imported registered drug “Venofer Injection” (Reg.No. 023654) from M/s. Vifor International Inc. Switzerlan to M/s. Tekeda Austria GmbH St Peter-Stresse, Austria. The Registration Board in its 254th meeting approved the change of manufacturing site subject to inspection of manufacturer abroad as per Import Policy for Finished Drugs. Though the product qualify for exemption of inspection of manufacturing site under the prevailing import policy, the
Minutes for 257th Registration Board Meeting 395 permission letter, however, was not issued since an investigation regarding alleged illegal increase in price of the drug in question i.e “Venofer Injection” (Reg.No. 023654) is being carried out by the National Accountability Bureau, Rawalpindi and in this regard seizer of some relevant documents relating to the “Venofer Injection” has already been made by the Bureau. Moreover, recently arrests of the owners of the firm has reportedly been made by the NAB authorities so in order to avoid possible repercussion on the under going investigation, the issuance of permission letter for change of manufacturing site of “Venofer Injection” was with held. M/s. RG Pharmaceuticals, Karachi has now filed a writ petition in Islamabad High Court, Islamabad for non issuance of approval letter. As per orders passed by the Court, the parawise comments are to be submitted within fortnight. The court further directed that the respondents shall fulfill their statutory obligations and report be filed within fortnight. The parawise comments are being filed.
Decision: Registration Board deliberated the matter in detail in the light of directions of Islamabad High Court, Islamabad regarding fulfillment of statutory obligation by the respondents. The Board observed that the case was already approved by the Board and since no restrictions are formally conveyed by the NAB in the case, so the Court’s directions should be complied by issuing permission letter to M/s. RG Pharmaceuticals, Karachi. A copy of the letter may also be endorsed to NAB Rawalpindi for their information. The Board further directed that the aforementioned action should be taken within the time frame prescribed by the Islamabad High Court, Islamabad without waiting formal approval of the minutes.
Case No. 09: Show Cause Notices Issued to the Firms having Registration of products containing Amantadine in combination with other Anti-Biotics and Ciprofloxacin.
Registration Board in its 249th meeting has decided to issue show cause notices to all the drug formaulation having Amantadine in combination with anti-viral drugs and Ciproflaxacine formulations for veterinary used. Accordingly show cause notices were issued to the firms having registrations of aforementioned drug formulations. A number of firms have responded with their point of view including request for personal hearings.
The Pakistan Poultry Association vide a written letter as requested to withdraw the show cause notices to the formulation containing Amantadine in combination with Anti-biotics claiming that it is not based on facts. The Pakistan Veterinary Pharmaceuticals Association has
Minutes for 257th Registration Board Meeting 396 also recommended that the Amantadine should not be withdrawn as it is widely used for poultry industry for Bird Flu.
Decision: Registration Board directed to place comments of all firms / stake holders before the Board in its next meeting.
Case No. 10: Request of M/s. Ghazi Brothers, Karachi for Change of Manufacturing Sites of their Registered Imported Drug(s).
M/s. Ghazi Brothers, Karachi has applied for change of manufacturing site for their following already registered products as per following details:- S. Reg. No. Name of Products. Existing Source Requested/proposed No. changes 1. 013014 Linco Spectin SS M/s. Pizer M/s. Zoetis Belgium Injection Manufacturing SA., Belgium Each ml contains:- Belgium, N.V., situated at Rue Laid Lincomycin ……. 50mg Belgium Burniat 1, B- 1348 Spectinomycin ... 100mg Louvain-la-Neuve (LLN) 2. 015481 Lutalyse Injection -do- -do- Each ml contains:- Dinoprost Tromethamine (equivalent to Donoprost) ……………… 5mg 3. 031517 Excenel RTU Injection M/s. Pharmacia & M/s. Zoetis Inc.2605 Each ml contains:- Upjohn Company, East Kilgore Road, Ceftiofur HCl equivalent USA Kalamazoo, to 50mg Ceftiofur Michigan, 49001, USA. Further the brand name has also changed to Excenel RTU EZ due to some modification in formulation as Ceftiofur Hydrochloride 50mg/ml
The firm have deposited required fee Rs.100, 000/- for each product and submitted following supporting documents:- i) Application o Form 5A. ii) Copies of initial registration letters & renewal status. iii) Original & legalized CoPPs.
Minutes for 257th Registration Board Meeting 397 iv) Legalized GMP certificate. v) Site master plans of concerned companies (submitted).
Decision: Registration Board approved the change of manufacturer/manufacturing site of above registered drugs on same terms and conditions as per following details:-
i. For Linco Spectin SS Injection (Reg. No. 013014) & Lutalyse Injection (Reg. No. 015481) from M/s. Pizer Manufacturing Belgium, N.V., Belgium to M/s. Zoetis Belgium SA., Belgium, Rue Laid Burniat 1, B- 1348 Louvain-la-Neuve (LLN). ii. For Excenel RTU Injection (Reg. No. 031517) from M/s. Pharmacia & Upjohn Company, USA to M/s. Zoetis Inc.2605 East Kilgore Road, Kalamazoo, Michigan, 49001, USA. Case No. 11 Grant of Additional Packs of already registered drugs.
M/s. Prix Pharmaceutica (Private) Limited, Lahore have requested for approval of additional packs of their following registered veterinary drugs as mentioned against each as the additional packs of the products are the requirement of the veterarian doctors as well as need of smaller scale consumers:-
S. # Reg. No. Name of Drug/Composition Existing Demanded Pack Additional packs 1. 043290 Erytac Water Soluble Powder 100gm 20gm sachet Each gm contains:- 500gm in box of Erythromycin (as thiocyanate)... 1000gm 25’s. 60mg Furaltadon (as hydrochloride)...150mg Tylosin (as tartrate) ……………50mg
2. 043285 Zoben 20 Water Soluble Granules 5gm 50gm jar. Each gm contains:- 100gm Albendazole ...... 200mg 1000gm
3. 049519 Metavit Super Water Soluble 100gm 20gm sachet Powder 200gm in box of (Vitamin preparation) 500gm 10’s. 1Kg 4. 043288 Pri-ADEK Water Soluble Powder 100gm 25gm sachet Each gm contains:- 500gm in box of Vitamin A ...... 50,000 IU 1000gm 10’s.
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Vitamin D3 ...... 5,000 IU Vitamin E (Alpha Tocopheryl Acetate……………….15.000mg Vitamin K3 (Menadiol Sodium Phosphate) ……………12.500mg
M/s. Prix Pharmaceutica (Private) Limited, Lahore have deposited the required fee Rs.5000/each and submitted following supporting documents: -
i) Copies of registration letters. ii) Copies of the acknowledgement of last renewal of registration of drugs.
M/s. Prix Pharmaceutica (Private) Limited, Lahore was advised to submit inspection report / proof of availability of 20gm, 25gm & 50gm packaging facility at their premises for grant of additional packaging of the above said drugs.
M/s. Prix Pharmaceutica (Private) Limited, Lahore have submitted that they have two automatic sachet filling machines with capacity of packaging from 5gm to 50gm and they are already packing 5gm and 10gm sachets of different registered products. They have also enclosed copy of inspection report and requested that additional packing of 20gm, 25gm & 50gm of above mentioned registered products may be approved. The case was deferred in its 250th meeting of Drug Registration Board for further evaluation of formulation and confirmation of me too status.
Decision: Registration Board approved demanded additional packs mentioned in Column No. V above on same terms and conditions.
Case No. 12: Request for Registration of Drug(s) by M/s. Ostuka Balochistan.
Registration Board in its 245th meeting deferred the following product of M/s. Otsuka, Balochistan for expert opinion of Incharge ICU Agha Khan University Hospital, Shoukat Khanum Memorial Hospital and Shifa Internatioal Hospital:- S. Name of firm Name of Drug(s) Demanded Shelf Decision No. & MRP life manufacturer 1. M/s Otsuka MIXID/ ® H Injection Rs.5748/ 18 Deferred for Pakistan Ltd. 900ml Per Mixed H months expert opinion
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(H.I,T,E), Distt. Each dual chamber soft 900ml of Lasbella, bag contains 900ml:- Incharge ICU Balochistan./ In upper chamber AKUH, M/s. Otsuka solution (fate emulsion SKMH and Pharmaceutical glucose solution...600ml SIH Factory Inc, In low chamber solution 115 Kuguhara, (amino acid and Tateiwa, Muya- electrolyte cho, Naruto, solution)……….300ml Tokushima, (Glucose, emulsion fat, Japan. amino acids, electrolytes).
2. M/s Otsuka Artcereb ® 500ml Rs.4826/ 03 Deferred for Pakistan Ltd. Injection Artcereb ® years expert opinion (H.I,T,E), Distt. Each dual chamber soft 500ml of Lasbella, bag contains 500ml:- Incharge ICU Balochistan. / In upper chamber AKUH, M/s. Otsuka solution…………150ml SKMH and Pharmaceutical In low chamber SIH Factory Inc, solution………….350ml 115 Kuguhara, (Glucose, emulsion fat, Tateiwa, Muya- amino acids, cho, Naruto, electrolytes). Tokushima, Japan.
Now the expert has provided their opinions as under:- S. Name of Recommendation for Artecereb Recommendation for MIXID-H No. Expert 1. Irfan Yousaf I have reviewed the supplied I have reviewed the supplied Consultant literature and product information literature and product information Neurosurgeon, and make the following and make the following Shoukat comments:- comments:- Khanum i. The need for an irrigation i. The formula is intended to be Memorial solution in cranial and spinal used in adult, having Cnacer, surgery having a constitution constitution that fulfill the Hospital. similar to Cerebrospinal fluid needs of patients requiring is satisfied by the product. TPN. ii. The packaging is designed to ii. The dual chamber soft bag ensure constitution of final packaging configuration is of product just before use to value in maintaining stability ensure stability. of the solution. iii. The studies carried out do not iii. A multi-center, phase-II and
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recommend the use of the an open lable study in Japan product in pregnant women demonstrate clinical efficacy and children, infants and and safety of both the neonates. solutions in a limited number iv. Lesser degree on brain oedema of patients. and cerebral vascular iv. However, the tow solution permeability have been shown contain carbohydrates, fats with the product when used in amino acids and electrolytes at rats against controls using a fixed combination, therefore Ringer Lactate, saline etc. daily adjustments of the TPN v. Only 48 patients were enrolled according to patient’s clinical in phase II trial. condition may not be possible.
vi. 117 patients were enrolled in v. Also the use will be limited the phase III trial which is non- for many patients, suffering randomized prospective study. from illnesses requiring limited volume such as CHF, vii. The solution is efficacious in low protein and controlled providing a clear field, electrolyte solutions such as removing debris and air. burn and CKD. viii. Based on results no adverse vi. Induction duration for MIXID reaction specific to the use of L solution is not clearly the product were reported mentioned. while examining the primary
end points of headache, nausea, vii. In view of significant risk of vomiting, Glagow Coma acidosis associated, pre- Score, and Serum electrolytes. emptive addition of vitamin B1 should be considered in ix. A phase III trial with larger MIXID L solution. number of patients would be
desirable to confirm viii. The formula can not be given therapeutic safety and efficacy. by peripheral line and after mixing, remains stable for 24 x. At the current price of Rs. hours only. 4826.00/Artecereb 500ml, the
product cannot be ix. Per literature dosage should be recommended for routine use adjusted according to the in Pakistan as the cost per patient’s condition, weight procedure will be substantial. and age which can be difficult. x. Patients may need 1-2 bags per day & cumulative sot for 24 hours may go up to 11,490 PKR, which we think is very costly. So therefore, formula can not be recommended for routine use in Pakistan. xi. Dur to above limitations and
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soct effectiveness, the product cannot be recofmmended for TPN use in Pakistan. 2. Dr. Madiha I received the request to review the I reviewed the literature and Hashmi, product Artcereb. Artecereb is a product information provided to Agha Khan solution that is similar in me. My observations and University composition and properties to the comments regarding the product Hospital, human cerebrospinal fluid. Most are as follows:- Karachi. studies show that it’s a sage MIXID-H will be a good option alternative to various irrigation for the provision of water, solutions currently being used electrolytes, amino acids, fat, and during neurosurgical procedures. calories in patients who require I recommend this product to be central venous nutrition because approved for use as an irrigation oral or enteral nutrition is solution in neurosurgical inadequate or not possible. A procedures in Pakistan. multi-center, phase-II and an open lable study conducted in Japan demonstrated clinical efficacy and safety of MIXID-H. The soft bag technology reduces the risks of infection/sepsis, air embolism and the dual chamber packaging is of value in maintaining stability and sterility of the product. Misid-H is a high priced product but the benefits offered in the nutritional management of critically ill patients in hospitals not having the facility of formulating parental nutrition outweigh its cost. Mixid-H will be a quality addition to the options available in the market that fulfill the needs of the patients requiring TPN. After evaluating this product based on the clinical data and in the light of my medical/clinical knowledge and expertise. I recommended this product to be approved for use in the nutritional management of patients requiring parenteral nutrition in Pakistan. 3. Dr. Aftab I have gone through the data I have gone through the data Akhtar, provided by the company on provided by the company on Shifa MIXID-H 900 mL and Artecereb MIXID-H 900 mL and Artecereb
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International 500 mL, both in dual chamber soft 500 mL, both in dual chamber Hospital, bags. soft bags. Islamabad. Scientific evidence supports the Scientific evidence supports the therapeutic efficacy of both the therapeutic efficacy of both the products with a favorable safety products with a favorable safety profile. The products have been profile. The products have been found to be suitable for use in our found to be suitable for use in our populations. Artcereb is a unique populations. Products similar to product and no such product is MIXID-D in soft bags are already available in Pakistan. available in the market. Artcereb These products are therefore, is a unique product and no such recommended for registration in product is available in Pakistan. Pakistan. These products are therefore, recommended for registration in Pakistan.
Decision: Since two experts has recommended registration of the drug, therefore, the Board decided to grant registration to MIXID/ ® H Injection 900ml & Artcereb ® 500ml Injection subject to inspection of manufacturer abroad as per Import Policy for Finished Drugs, verification of storage facilities and price fixation / calculation etc.
Minutes for 257th Registration Board Meeting 403
Registration-IV
Case No.13: Registration of drugs for Export Purpose.
Following firms have applied for registration of drugs for the purpose of export only:-
S. # Name of Name of Drug (s)/Composition. Remarks Manufacturer 1. M/s. Polyfine Sofos 400mg Tablets Original Export order Chempharma, Each film coated tablet contains:- Form-5 not signed. Peshawar Sofosbuvir……………..400mg
2 M/s. Wnsfeild Tributin SR Tablets 300mg Notary Export order Pharmaceuticals, Each film coated tablet contains:- In method of Hattar Trimebutine as maleate…...300mg manufacturing name of active ingredient is not correctly mentioned. 3 M/s. Rock Pro. Vit Syrup Export order Pharmaceuticals, Each 5ml contains:- Risalpur Thiamine HCl (Vit B1)……….….1mg Riboflavin (Vit B20………………1mg Pyridoxine HCl 9Vit B6)…….…0.5mg Cyanocobalamin (Vit.B12)…..….3mcg Niacinamide………….………….10mg Dexpanthenol………………....…..3mg Vitamin A…………..…..…….1.50mg Cholecalciferol (Vit.D3)…....….400mg Ascorbic Acid (Vit.C)……………60mg
4 M/s. Caliph Mokzal Oral Liquid Suspension Export order Pharmaceuticals, Each 5ml contains:- Risalpur. Aluminium Hydroxide…….405mg Magnesium Hydroxide…….100mg
5 M/s. Legacy Calvitol-S Syrup Original Export order Pharmaceuticals, Each 5ml contains:- Peshawar Calcium lactate Gluconate……..40mg Vitamin A……………………..1200IU Vitamin D3……………………..100IU Vitamin B1……………………….1mg Vitamin B2………………...……..1mg Vitamin B6……………………..0.5mg Nicotinamide……………..………5mg Dexpanthenol………………….…2mg
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Vitamin C………………….…….50mg Vitamin E Acetate………..………1mg Zinc Sulphate..……………….…..2mg
The firm submitted all the relevant documents along with the fee of Rs.20000/-, Rs. 50,000/- and requested for registration of drugs for export purpose only.
Decision Registration Board decided as follows: For products at S.No. 02-05, firm will deposit remaining fee for new formulation before issuance of registration letter. For products at S.No.1 and 2, the Board approved the products and authorized its Chairman for issuance of letter after rectification of shortcomings. Products at S.No.3-5 are approved for registration for export purpose only.
Case No.14: Change in formulation.
M/s. Wnsfeild Pharmaceuticals, Hattar has requested for change in formulation of their following registered product for being highly unstable:-
Reg No. Existing Formulation Suggested Formulation
064344 Wiproate 250mg Tabelts Wiproate 250mg Tabelts Each tablet contains:- Each enteric coated tablet contains:- Sodium Valproate….250mg Divalproex Sodium (Wnsfeild Spec) ≡Valproic Acid……..…….250mg (Wnsfeild Spec)
064345 Wiproate 500mg Tabelts Wiproate 500mg Tabelts Each tablet contains:- Each enteric coated tablet contains:- Sodium Valproate….500mg Divalproex Sodium (Wnsfeild Spec) ≡Valproic Acid……..…….500mg (Wnsfeild Spec)
The management of the firm deposited Rs.20,000/- each for the purpose and requested for issuance of change of formulation.
Decision Registration Board directed to advise the firm to submit complete Form-5 for proposed change for consideration.
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Case No.15: Correction in formulation Registration Board in 254th meeting approved following drug of M/s. Wnsfeild Pharmaceuticals, Hattar but registration letter was not issued as applied formulation was not standard. S. No. Applied Formulation Standard formulation 1 Moflex 400mg/100ml infusion Moflex 400mg/250ml infusion Each 100ml vial contains Each 250ml vial contains Moxifloxacin as HCl…… 400mg Moxifloxacin as HCl ……..400mg Antibiotics Antibiotics (Manufacture Specification) (Manufacture Specification)
The management of the firm vide letter has requested for issuance of registration letter with above mentioned standard formulation. Decision Registration Board approved the correction in formulation as per standard formulation.
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Registration-II
Case No. 16 Registration of Drugs for Export Purpose of Non-Me too Drugs (New Drugs) a. Grant of export registration Following firms have requested for registration of following drugs for export purpose only which are not me-too & are new drugs. Details are as under:- S. Name of Company Name of product(s) Date of Export Order Approval # application, status by Diary No. reference regulatory authorities 1. M/s. Hilton Pharma Sazil 40mg Tablets 26.02.2016 Copy of USFDA (Pvt) Ltd., Each tablet contains: 09 export order 13-14, Sector 15, Azilsartan Kamedoxomil Rs. 50,000/- from Korangi Industrial eq. to Azilsartan Afghanistan Area, Medoxomil….40mg Karachi.
2. -do- Salzil 80mg Tablets 26.02.2016 Copy of USFDA Each tablet contains: 15 export order Azilsartan Kamedoxomil Rs. 50,000/- from eq. to Azilsartan Afghanistan Medoxomil……80mg 3. -do- Co-Sazil 40/12.5mg 26.02.2016 Copy of USFDA Tablets 13 export order Each film coated tablet Rs. 50,000/- from contains: Afghanistan Azilsartan Medoxomil…..40mg Chlorthalidone….12.5mg 4. -do- Co-Sazil 40/25mg Tablets 26.02.2016 Copy of USFDA Each film coated tablet 11 export order contains: Rs. 50,000/- from Azilsartan Afghanistan Medoxomil….40mg Chlorthalidone……25mg 5. -do- Am-Sazil 20/5mg Tablets 26.02.2016 Copy of Japan Each film coated tablet 14 export order contains: Rs. 50,000/- from Azilsartan Kamedoxomil Afghanistan eq. to Azilsartan Medoxomil……20mg Amlodipine………..5mg
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6. -do- Am-Sazil 20/2.5mg Tablets 26.02.2016 Copy of Japan Each film coated tablet 12 export order contains: Rs. 50,000/- from Azilsartan Kamedoxomil Afghanistan eq. to Azilsartan Medoxomil……20mg Amlodipine………..2.5mg 7. -do- Tri-Omsana 40/5/12.5mg 26.02.2016 Copy of USFDA Tablets 16 export order Each film coated tablet Rs. 50,000/- from contains: Afghanistan Olmesartan Medoxomil…40mg Amlodipine Besylate eq. to Amlodipine…….5mg Hydrochlorothiazide.12.5m g 8. -do- Tri-Omsana 40/10/12.5mg 26.02.2016 Copy of USFDA Tablets 18 export order Each film coated tablet Rs. 50,000/- from contains: Afghanistan Olmesartan Medoxomil…40mg Amlodipine Besylate eq. to Amlodipine…….10mg Hydrochlorothiazide……1 2.5mg 9. -do- Tri-Omsana 20/5/12.5mg 26.02.2016 Copy of USFDA Tablets 17 export order Each film coated tablet Rs. 50,000/- from contains: Afghanistan Olmesartan Medoxomil…20mg Amlodipine Besylate eq. to Amlodipine…….5mg Hydrochlorothiazide…… ……………….12.5mg 10. -do- Tri-Omsana 40/5/25mg 26.02.2016 Copy of USFDA Tablets 10 export order Each film coated tablet Rs. 50,000/- from contains: Afghanistan Olmesartan Medoxomil…40mg Amlodipine Besylate eq. to Amlodipine…….5mg Hydrochlorothiazide.25mg
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11 -do- Tri-Omsana 40/10/25mg 26.02.2016 Copy of USFDA Tablets 19 export order Each film coated tablet Rs. 50,000/- from contains: Afghanistan Olmesartan Medoxomil…40mg Amlodipine Besylate eq. to Amlodipine…….10mg Hydrochlorothiazide.25mg 12. -do- Paromi Tablets 26.02.2016 Copy of USFDA Each film coated tablet 20 export order contains: Rs. 50,000/- from Ombitasvir……12.5mg Afghanistan Paritaprevir……75mg Ritonavir………50mg 13. -do- Rocop 500mcg Tablets 26.02.2016 Copy of USFDA Each tablet contains: 21 export order Roflumilast………500mcg Rs. 50,000/- from Afghanistan 14. M/s Akhai Ledovir Tablets 16 Copy of USFDA Pharmaceutical Each film coated tablet Rs. 20,000/- export order (Pvt) Ltd., A-248, contains 26.02.2016 from A-256 to A-259, Sofosbuvir………400mg Rs. 30,000/- Afghanistan H.I.T.E. Lasbela, Ledipasvir………..90mg 14.03.2016 Baluchistan 15. M/s Pliva Pakistan Rogophen Ear Drops 5% 07.01.2016 Purchase MHRA (Pvt) Ltd., Plot #B- Each 100ml contains: 01 contract 77, Hub Industrial Chloramphenicol…….5gm Rs. 20,000/- between Trading Estate, 24.02.2016 Royal Group Baluchistan. Rs. 30,000/- and Pliva Pakistan for Srilinka 16 M/s PharmEvo Anplag 180mg Tablet 14-12-2015 Copy of Not found Pharmaceuticals, Each tablet contains: 1002 export order in reference Karachi. Ticagrelor……..180 mg Rs.20,000/- from Srilanka countries
17 -do- Sofodek 400/30mg Tablet 14-12-2015 Copy of Not found Each tablet contains: 1005 export order in reference Sofosbuvir……400mg Rs.20,000/- from Srilanka countries Daclatasvir……30 mg 18 -do- Sofodek 400/90mg Tablet 14-12-2015 Copy of Not found Each tablet contains: 1003 export order in reference Sofosbuvir……400mg Rs.20,000/- from Srilanka countries Daclatasvir……90 mg
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19 -do- Sofodek 400/60mg Tablet 14-12-2015 Copy of Not found Each tablet contains: 1004 export order in reference Sofosbuvir……400mg Rs.20,000/- from Srilanka countries Daclatasvir……60 mg 20 M/s Sami Daclavir 30mg Tablet 22-03-2016 Copy of USFDA Pharmaceuticals, Each tablet contains: 396 export order Karachi. Daclatasvir……..30 mg Rs.50,000/- from Afghanistan
21 -do- Winvir 400mg/90mg 22-03-2016 Copy of USFDA Tablet 397 export order Each tablet contains: Rs.50,000/- from Sofosbuvir…….400mg Afghanistan Ledispasvir……90 mg
Decision: Registration Board decided as follows: Approved items at S.No. 01-15, 20 and 21 as these are approved by regulatory authorities of reference countries. For items at S.No.16-19, Registration Board advised applicants to deposit remaining fee and provide approval status by regulatory authority of importing country and authorized Chairman for grant of registration. Registration Board will be informed accordingly.
b) Change in contract manufacturing of drugs registered for export purpose only. M/s AGP (Private) Limited B-23, S.I.T.E. Karachi was granted extension in contract manufacturing permission of following products for export purpose only from M/s PharmEvo, Pharmaceuticals, Karachi till 30-06-2020 in 254th meeting of Registration Board. Now the firm has requested for change in contract manufacturing from M/s PharmEvo pharmaceuticals Karachi to M/s UDL, Pharmaceuticals, Karachi.
S. Name of product(s) Registration Date of No. No. application, Diary No.
1. Neogene 500mg Injection I.V. Ex-002691 14.03.2016 Each vial contains: 399 Ceftriaxone……….….500mg Rs. 50,000/-
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2. Neogene 1g Injection I.V. Ex-002692 14-3-.2016 Each vial contains: 400 Ceftriaxone …….………1gm Rs. 50,000/-
3 Kefzol 500mg Injection Ex-003755 14-03-2016 Each vial contains: 397 Cefazolin sodium……..500 mg Rs.50,000/-
4 Kefzol 1g Injection Ex-003756 14-03-2016 Each vial contains: 396 Cefazolin sodium……….1gm Rs.50,000/-
Decision: Regsitration Board approved change in contract manufacturer for above products to M/s UDL, Pharmaceuticals, Karachi. Permission is at same terms and conditions. c) Grant of export registration on contract manufacturing cases - M/s AGP (Private) Limited B-23, S.I.T.E. Karachi.
S. Name of product(s) Date of Export Order No. application, Diary No.
1. Neogene 500mg Injection I.M 26.02.2016 Copy of export Each vial contains: 401 order from Ceftriaxone……….….500mg Rs. 50,000/- Afghanistan
2. Neogene 1g Injection I.M 26.02.2016 Copy of export Each vial contains: 398 order from Ceftriaxone …….………1gm Rs. 50,000/- Afghanistan
Decision: Regsitration Board approved grant of export registration on contract manufacturing basis from M/s UDL, Pharmaceuticals, Karachi. Permission is at same terms and conditions.
Minutes for 257th Registration Board Meeting 411 d. Deferred case for evidence of approval in reference agencies.
Registration Board in its 254th meeting deferred the following application of M/s Sami Pharmaceuticals, Karachi for evidence of approval in reference agencies.
Trimetabol Oral Solution 08.06.2015 Copy of Approved by Each 100ml contains 243 import regulatory Cyproheptadine Acefilinate Rs. 20,000/- Order from authority of Spain (Metopine®)……………35mg Switzerland L-lysine HCl………………..5g DL-Carnitine HCl……….7.5g Thiamine HCl (Vitamin B1)……………………600mg Pyridoxine HCl. (vitamin B6)……………………600mg Cyanocobalamin (vitamin B12)………………..….20mg
Now, the firm has provided list of following countries where the above formulation is registered.
S.No. Name of country S.No. Name of country 1 Spain 8 RD Congo 2 Kazakhistan 9 Ukraine 3 Tanzania 10 Ivory Coast 4 Malta 11 Rep Chad 5 Niger 12 Guinea 6 Togo 13 Senegal 7 Congo
The firm has requested for re-consideration of its application since the above formulation is available in two European union countries that is Malta & Spain.
Registration Board advised applicants to deposit remaining fee and provide approval status by regulatory authority of importing country and authorized Chairman for grant of registration. Registration Board will be informed accordingly.
e. Deferred cases of Registration of Drugs for export purpose - Not me too (New Drugs)
Registration Board in its 254th meeting deferred the following application of M/s Kaizen Pharmaceuticals, karachi for export purpose through contract manufacturing from M/s UDL Pharma, Karachi M/s UDL Pharma, Karachi for evidence of registration in reference agencies. M/s UDL, Pharma posses the manufacturing facility for capsule (Cephalosporin)
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S. Name of Contract Name of product(s) for Date of Remarks No. applicant manufacturer export application, Diary No. & Form 1. M/s Kaizen UDL Pharma, Serve Capsule 200mg 18.08.2015 Product not Pharmaceutical, Karachi. Each capsule contains: 229 available in Karachi. Cefixime (as Rs.20,000/- USA & UK. trihydrate)….200mg
The firm has requested for re-consideration of registration.
Decision: Registration Board advised applicants to deposit remaining fee and provide approval status by regulatory authority of importing country and authorized Chairman for grant of registration. Registration Board will be informed accordingly.
Case No. 17 Change of Registrations from one manufacture to an others/site changes.
a. Change of Registration of product from Import to Local Manufacturing through contract manufacturing (Site change).
M/s B. Braun Pakistan (Pvt) Ltd., The forum, Suite 216, Khayaban-e-Jami, Cliftan Block 9, Karachi have applied for change of registration of their following product from import to local through contract manufacturing from M/s Frontier Dextrose Limited, Plot No. 18/3, Phase-I, Hattar Industrial Estate, Haripur.
Sl No. Regn No. Name of drug(s) and Source of import composition 1. 059016 Ecoflac Plus – NS, M/s B. Braun Medical Each 100ml Contains: Industries Sdn. Bhd., Sodium Chloride for Malaysia parentral use ……….0.9gm
In support of his request, the firm has submitted following documents: 1) Required fee as per relevant SRO Rs. 50,000/- for each product. 2) Application on form -5 3) Copy of registration letter (12-8-2009)/renewal status (submitted on 7-2- 2014). 4) Copy of NOC for CRF clearance (Not applicable since applicant is importer). 5) Inspection for renewal of DML (21-9-2013) verifying the section I.V infusion. Minutes for 257th Registration Board Meeting 413
6) Under taking for unchanged formulation, API source manufacturing procedure, analytical test methods & finished product specifications.
The firm has not submitted the following documents as per SOP for approval of his request:
a. Accelerated stability studies of 6 months with undertaking to conduct real time stability studies up to assigned shelf life & report if any result falls outside shelf life specifications (with proposed action). b. Validated method of analysis, master formula and product development data
Decision: Registration approved permission for contract manufacturing of product from M/s Frontier Dextrose Limited, Plot No. 18/3, Phase-I, Hattar Industrial Estate, Haripur for 05 years. Firm will rectify shortcomings in application and Chairman, Registration Board will be authorized for issuance of letter.
c. Change of Registration of product from Import to Local Manufacturing through contract manufacturing (Site change).
M/s Allied Distributors, Akhai Arcade, 1st Floor, 103-K, Block – 2 PECHS, Shahra-e- Quaideen, Karachi have applied for change of registration of their following products from import to local through contract manufacturing from M/s NovaMed Pharmaceutical (Ltd), Lahore. Brand Composition Reg.No. Mecomin Injection Each ampoule contains: 022667 Mecobalamine……500mcg
The firm has submitted the following documents in support of his request: 1) Agreement for contract manufacturing. 2) Evidence of approval of manufacturing facility of M/s Noamed, Lahore. 3) Fee submitted @ Rs.8000/- dated 28th April, 2010 & Rs.42000/- dated 15th July, 2014. 4) Renewal is not due since the product was transferred from import to local manufacturing on 26-01-2010 and the firm submitted the last renewal on 03-10-2013. The firm has not submitted the following documents as per SOP for approval of his request:
a. Accelerated stability studies of 6 months with undertaking to conduct real time stability studies up to assigned shelf life & report if any result falls outside shelf life specifications (with proposed action).
b. Validated method of analysis, master formula and product development data
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Decision: Registration approved permission for contract manufacturing of Mecomin Injection from M/s NovaMed Pharmaceutical (Ltd), Lahore for 05 years. Firm will rectify shortcomings in application and Chairman, Registration Board will be authorized for issuance of letter. c. Change of Registration of product from Import to Local Manufacturing through contract manufacturing (Site change).
M/s Akhai agencies, Akhai Arcade, 2nd Floor, 103-K, Block – 2 PECHS, Shahra-e- Quaideen, Karachi have applied for change of registration of their following products from import to local through contract manufacturing from M/s Nova Med Pharmaceutical (Ltd), Lahore.
Brand Generic Reg.No. Stigma Inj. Each ml contains: 022667 1 ml Neostigmine methylsulphate ………2.5 mg /ml
The firm has submitted the following documents in support of his request: 1) Agreement for contract manufacturing. 2) Evidence of approval of manufacturing facility of M/s Noamed, Lahore. 3) Fee submitted @ Rs.8000/- dated 28th April, 2010 & Rs.42000/- dated 15th July, 2014. 4) Renewal has been submitted which is valid till 11-5-2020.
The firm has not submitted the following documents as per SOP for approval of his request:
a. Accelerated stability studies of 6 months with undertaking to conduct real time stability studies up to assigned shelf life & report if any result falls outside shelf life specifications (with proposed action).
b. Validated method of analysis, master formula and product development data
Decision: Registration approved permission for contract manufacturing of Stigma Inj. 1 ml from M/s NovaMed Pharmaceutical (Ltd), Lahore for 05 years. Firm will rectify shortcomings in application and Chairman, Registration Board will authorize issuance of letter.
Minutes for 257th Registration Board Meeting 415 d. Change of Registration of product from previous site to New site (Site change).
M/s Novartis Pharma (Pakistan) Ltd., 15-West Wharf Road, Karachi have applied for change of registration of their following product from Novartis West Wharf, Karachi (DML No. 000193) to M/s. Novartis Pharma Jamshoro (DML No. 000010). Sl No. Regn No. Name of drug(s) and Remarks composition 1. 044389 Sanlac Syrup - Each 100ml contains: Lactulose……………..67gm Galactose……………..11gm Lactose………………..6gm
In support of his request, the firm has submitted following documents: 1) Required fee as per relevant SRO Rs. 100,000/- for each product. 2) Application on form -5 3) Copy of registration letter (previous approval of transfer of registration to M/s Novartis, dated 24-7-2009)/renewal status (submitted on 18-7-2014). 4) Copy of NOC for CRF clearance. 5) Inspection for renewal of DML 6) Under taking for unchanged formulation, API source manufacturing procedure, analytical test methods & finished product specifications.
The firm has not submitted the following documents as per SOP for approval of his request:
a. Accelerated stability studies of 6 months with undertaking to conduct real time stability studies up to assigned shelf life & report if any result falls outside shelf life specifications (with proposed action). b. Validated method of analysis, master formula and product development data
Decision: Registration Board deferred the case for confirmation of renewal status.
c. Change of Registration of products from one manufacturer to another (Site change).
M/s CKD Pharmaceutical Pakistan (Pvt) Ltd., 50/28, Korangi Industrial Area, Shahrah-e-Faisal, Karachi have applied for change in registration of their following products from M/s Indus Pharma (Pvt) Ltd., Karachi to their name.
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Sl No. Regn No. Name of drug(s) and Remarks composition 1. 042476 Indopol 125mg Oral Suspension - Each 5ml contains: Cefadroxil (as Cefadroxil Monohydrate)…….…..125 mg (USP/Manufacturer’s Specification) 2. 042477 Indopol 250mg Oral Suspension - Each 5ml contains: Cefadroxil (as Cefadroxil Monohydrate)………...250 mg (USP/Manufacturer’s Specification) 3. 042475 Indopol 500mg Capsules - Each capsule contains: Cefadroxil (as Cefadroxil Monohydrate)………...500 mg (USP/Manufacturer Specification)
In support his request the firm has submitted following documents: 1) Required fee as per relevant SRO Rs. 20,000/- for each product. 2) Application on form -5 3) Copy of registration letter (15-7-2006)/renewal status (submitted on 14-7- 2011). 4) Copy of NOC for CRF clearance. 5) Inspection for renewal of DML 6) Under taking for unchanged formulation, API source manufacturing procedure, analytical test methods & finished product specifications.
The firm has not submitted the following documents as per SOP for approval of his request:
a. Accelerated stability studies of 6 months with undertaking to conduct real time stability studies up to assigned shelf life & report if any result falls outside shelf life specifications (with proposed action). b. Validated method of analysis, master formula and product development data.
Registration Board decided as follows: 1. Cancellation of registrations of product from M/s Indus Pharma (Pvt) Ltd., Karachi. 2. Registration of products in the name of M/s CKD Pharmaceutical Pakistan (Pvt) Ltd., 50/28, Korangi Industrial Area, Karachi. Firm will rectify shortcomings and Chairman, Registration Board will authorize issuance of registration letter. 3. Registration Board authorized its Chairman for issuance of registration letters after MRP fixation by Cost & Pricing Division.
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d. Change of registration of product from one manufacturer to an other manufacturer (site change) M/s GlaxoSmithKline Pakistan Limited, F-268, S.I.T.E, Karachi have requested for change of registration of following products from the name of M/s AGP (Pvt) Limited B-23, S.I.T.E, Karachi to their name. The details are as under:
S.# Regn No. Name of Product(s) with Initial date Renewal valid specification of up to registration 1. 019757 Nootropil Syrup 20% 07.08.1996 13-6-2016 Each 100ml contains: Piracetam (oral grade)…20gm 2. 006951 Nootropil Tablet 800mg 30.01.1984 27.02.2021 Each tablet contains: Piracetam……….800mg 3. 007592 Atarax Tablet 25mg 15.11.1984 27.02.2021 Each film coated tablets contains: Hydroxyzine Dihydrochloride…..25mg
In support his request the firm has submitted following documents: i. Required fee as per relevant SRO Rs. 20,000/- for each product. ii. Application on form -5 iii. Copy of registration letter /renewal status. iv. Copy of NOC for CRF clearance. v. Approval of new name/title from CLB vi. Under taking for unchanged formulation, API source manufacturing procedure, analytical test methods & finished product specifications. vii. Accelerated stability studies of 6 months with undertaking to conduct real time stability studies up to assigned shelf life & report if any result falls outside shelf life specifications (with proposed action). viii. Validated method of analysis, master formula and product development data.
Registration Board decided as follows:
Product at S.No.01 deferred for confirmation of approval status by reference regulatory authorities.
Products at S.No.02 deferred for expert opinion as per decision of 250th registration Board meeting.
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For product at S.No.03:
1. Cancellation of registrations of product from M/s AGP (Pvt) Limited B-23, S.I.T.E, Karachi. 2. Registration of products in the name of M/s GlaxoSmithKline Pakistan Limited, F- 268, S.I.T.E, Karachi. 3. Registration Board authorized its Chairman for issuance of registration letters after MRP fixation by Cost & Pricing Division.
e. Change of registration of product from one manufacturer to an other manufacturer (Site change)
M/s Genix Pharma (Pvt) Ltd., 44,45-B, Korangi Creek Road, Karachi has requested for change of registration from the name of M/s Epoch Pharma (Pvt) Ltd., Plot No. 83-85, Sector No. 15, Korangi Industrial Area, Karachi to their name. The details are as under:
S.# Reg.No Product for Date of Renewal Remarks registration with Initial submitted generic name Registration on 1. 048597 RSV Tablet 400mg 10-5-2008 14.05.2013 Renewal is Each tablet contains: not Ribavirin….…400 mg submitted (BP Specification) within 5 years 2. 048598 RSV Tablet 600mg 10-5-2008 10.05.2013 -do- Each tablet contains: Ribavirin……..600 mg (BP Specification)
In support his request, the firm has submitted following documents: i. Required fee as per relevant SRO Rs. 20,000/- for each product. ii. Application on form -5 iii. Copy of registration letter/renewal status. iv. Copy of NOC for CRF clearance. v. Approval of new name/title from CLB vi. Under taking for unchanged formulation, API source manufacturing procedure, analytical test methods & finished product specifications. vii. Accelerated stability studies of 6 months with undertaking to conduct real time stability studies up to assigned shelf life & report if any result falls outside shelf life specifications (with proposed action). viii. Validated method of analysis, master formula and product development data.
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Registration Board decided as follows: 1. Cancellation of registrations of product from M/s Epoch Pharma (Pvt) Ltd., Plot No. 83-85, Sector No. 15, Korangi Industrial Area, Karachi. Registration Board approved validity of registration of these products. 2. Registration of products in the name of M/s Genix Pharma (Pvt) Ltd., 44,45-B, Korangi Creek Road, Karachi.. 3. Registration Board authorized its Chairman for issuance of registration letters after MRP fixation by Cost & Pricing Division.
f. Change of registration of product from one manufacturer to another manufacturer along with contract manufacturing from the previous manufacturer
M/s AGP (Private) Limited B-23, S.I.T.E, Karachi have requested for change of registration of following product from the name of M/s Wenovo Pharmaceutical Plot No. 31-32, Punjab Small Industrial Estate, Taxila to their name. The details are as under:
S.# Regn No. Name of Product(s) with Initial date Renewal valid specification of up to registration 1. 077879 Calfina Plus Tablet 17.06.2014 Renewal not due Each film coated tablet as the product contains: was registered on Tramadol 17.06.2014 HCl………37.5mg Acetaminophen…..325mg (USP Speecification
In support his request, the firm has submitted following documents: i. Required fee as per relevant SRO Rs. 20,000/-. ii. Application on form -5 iii. Copy of registration letter/renewal status. iv. Copy of NOC for CRF clearance. v. NOC from contract manufacturer i.e. M/s Wenovo Pharmaceutical for transfer of registration. vi. M/s AGP submitted that they are already manufacturing a number of products in tablet form and now at the moment they don’t have capacity to manufacture same product at our premises.
Decision: Registration Board decided as follows: 1. Cancellation of registrations of product from M/s Wenovo Pharmaceutical Plot No. 31-32, Punjab Small Industrial Estate, Taxila. 2. Registration of products in the name of M/s AGP (Private) Limited B-23, S.I.T.E, Karachi and contract manufacturing by M/s Wenovo Pharmaceutical Plot No. 31-
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32, Punjab Small Industrial Estate, Taxila. As per Rule 20 A of Drugs (L R & A) Rules,1976 . 3. Registration Board authorized its Chairman for issuance of registration letters after MRP fixation by Cost & Pricing Division.
Case No.18 Change of registration from previous name to new title name (Site remains same)
a.(i) The name of M/s Searle Pakistan Limited, Karachi has been changed to new title i.e. M/s The Searle Company Limited, Karachi. Accordingly the firm has applied for change in the registration of following products from previous name to its new title as per following details:
Reg. Formulation / Date of International S.no. Brand Name(s) Renewal Status No. Generic Name registration availability Ibandronate Adronil Valid up to 0758 Sodium eq. to 18/4/2013 US FDA 1. 3mg/3ml 18/4/2018 70 Ibandronate Injection Acid 3mg/3ml Rs.10,000 Received Renewal 0473 Alcorib 400mg Ribavirin 02/1/2008 Application US FDA 2. 85 Tablets 400mg 01/01/2013 Valid up to 01/01/2018 Rs.10,000 Received Renewal 0473 Alcorib 500mg Ribavirin 02/1/2008 Application US FDA 3. 86 Tablets 500mg 01/01/2013 Valid up to 01/01/2018
Rs.10,000 Received Renewal 0473 Alcorib 600mg Ribavirin 02/1/2008 Application US FDA 4. 87 Tablets 600mg 01/01/2013 Valid up to 01/01/2018
Valid up to Imiquimod 02/09/2014 0522 Aldara 5% 12.5mg 02/9/2009 Request for transfer EMA 5. 22 Cream (Imported of registration Drug) applied on 01/01/2014 but
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deposited fee on 12/12/2013 the application shows date 06-12-2013
Request for transfer of registration applied on Flupentixol 01/01/2014 but 0533 UK 6. Alpent Injection Decanoate 15/12/2008 deposited fee on 40 20mg/ml 12/12/2013 the application shows date 06-12-2013
Request for transfer of registration applied on Flupentixol 01/01/2014 but 0533 EMA 7. Alpent Injection Decanoate 15/12/2008 deposited fee on 41 100mg/ml 12/12/2013 the application shows date 06-12-2013
Rasagiline as Valid up to 0704 Alzilo 0.5mg US FDA 8. Mesylate 21/4/2011 21/7/2016 18 Tablets 0.5mg Valid up to 0704 Alzilo 1mg Rasagiline as 21/4/2011 US FDA 9. 21/7/2016 19 Tablets Mesylate 1mg Request for transfer of registration 15/12/2008 applied on
Tranexamic 01/01/2014 but Not Found in 0533 Anzica 10. Acid deposited fee on USA, Australia, 43 Injection 250mg/5ml 12/12/2013 the Canada, Japan &
application shows UK.
date 06-12-2013
Change of brand Omeprazole Registered as name to ANZO enteric coated 0671 Anzo 20 OMEPRAZAL Capsule 20mg US FDA 11. pellets eq. to 11 Capsules 20mg Capsule 12/02/2011 Omeprazole 29/11/2010 Valid up to 20mg 12/02/2016 0671 Anzo 40 Omeprazole Registered as Change of brand US FDA 12. 12 Capsules enteric coated OMEPRAZAL name to ANZO
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pellets eq. to 40mg Capsule Capsule 40mg Omeprazole 29/11/2010 12/02/2011 40mg Valid up to 12/02/2016 Prasugrel as Valid up to 0675 Ascorel 5mg 07/4/2011 US FDA 13. hydrochloride 07/4/2016 57 Tablets 5mg Prasugrel as Valid up to 0675 Ascorel 10mg 07/4/2011 US FDA 14. hydrochloride 07/4/2016 58 Tablets 10mg Request for transfer of registration applied on Atracurium 0533 Atrium 01/01/2014 but US FDA 15. Besylate 15/12/2008 42 Injection deposited fee on 10mg/ml 12/12/2013 the application shows date 06-12-2013 Received Renewal Application 0451 Zofenopril 16. Bifril Tablet 28/2/2007 03/01/2012 Not confirmed 65 Calcium 30 mg Valid up to 03/01/2017 Renewed up to 25/4/2014 Request for transfer of registration applied on 0073 Calan Tablet Verapamil HCl 25/4/1984 01/01/2014 US FDA 17. 09 40mg 40mg but deposited fee on 12/12/2013 the application shows date 06-12- 2013
Renewed up to 22/5/2014 Request for transfer of registration applied on 0073 Calan Tablet Verapamil 18. 22/5/1984 01/01/2014 but US FDA 10 80mg 80mg deposited fee on 12/12/2013 the application shows date 06-12-2013
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Received Renewal Application 17/05/2010 Request for transfer of registration 0392 Thiocolchicosi 15/6/2005 19. Colril Capsule applied on Not confirmed 61 de 4mg 01/01/2014 but deposited fee on 12/12/2013 the application shows date 06-12-2013
Request for transfer of registration Olmesartan applied on 0580 Co-Olesta 20mg, 01/8/2009 01/01/2014 but 20. US FDA 22 Tablets Hydrochlorothi deposited fee on azide 12.5mg 12/12/2013 the application shows date 06-12-2013
Request for transfer of registration applied on Olmesartan 01/01/2014 but 0580 Co-Olesta 40mg, 01/8/2009 21. deposited fee on US FDA 23 Tablets Hydrochlorothia 12/12/2013 the zide 12.5mg application shows date 06-12-2013
Request for transfer of registration applied on Diclofenac 01/01/2014 but 0533 Defnac 22. Sodium 15/12/2008 deposited fee on UK 38 Injection 75mg/3ml 12/12/2013 the application shows date 06-12-2013
Request for transfer of registration 0618 Defnac 50mg Diclofenac 31/8/2010 applied on US FDA 23. 75 Tablets Sodium 50mg 01/01/2014 but Enteric coated deposited fee on 12/12/2013 the
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application shows date 06-12-2013
Request for transfer of registration applied on 01/01/2014 but 0618 Defnac 75mg Diclofenac 31/8/2010 US FDA 24. deposited fee on 76 Tablets Sodium 75mg Enteric coated 12/12/2013 the application shows date 06-12-2013
Request for transfer of registration applied on 01/01/2014 but 0671 Defnac SR Diclofenac 25. 29/11/2010 deposited fee on US FDA 10 100mg Tablets Sodium 100mg 12/12/2013 the application shows date 06-12-2013
4/2/2006 change of brand name from Gabtin to Duogab 0396 Duogab 300mg Gabapentin 26. 01/12/2005 Received Renewal 84 Capsules 300mg US FDA Application 10/01/2011
4/2/2006 change of brand name from Gabtin to Duogab 0396 Duogab 400mg Gabapentin 27. 01/12/2005 Received Renewal 85 Capsules 400mg US FDA Application 10/01/2011
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4/2/2006 change of brand name from Gabtin to Duogab 0396 Duogab 100mg Gabapentin 28. 01/12/2005 Received Renewal US FDA 83 Capsules 100mg Application 10/01/2011
Received Renewal Application 27/10/2009 Request for transfer of registration 29. 503590 Ezebrix 10mg Ezetimibe 30/12/2004 applied on US FDA 2 3 Tablets 10mg 01/01/2014 but deposited fee on 12/12/2013 the application shows date 06-12-2013 Received Renewal Application 28/01/2010 Request for transfer Fenofibrate of registration 30. 502409 Fenogal 28/1/2005 (Ph. Eur) applied on US FDA 5 5 Capsules 200mg 01/01/2014 but deposited fee on 12/12/2013 the application shows date 06-12-2013 Received Renewal Application 28/01/2010 Request for transfer Glibenclamide of registration 31. 503667 2.5mg, 28/1/2005 applied on Glibomet Tablet 6 0 Metformin HCl 01/01/2014 but India 400mg deposited fee on 12/12/2013 the application shows date 06-12-2013
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Received Renewal Application 17/09/2013 Request for transfer Glimepiride….2 of registration 32. 505073 Glimp Extra 24/9/2008 mg Pioglitazone applied on USA 7 3 Tablets (as HCl) 30mg 01/01/2014 but deposited fee on 12/12/2013 the application shows date 06-12-2013 Received Renewal Glimepiride… Application .4mg 33. 505073 Glimp Extra 24/9/2008 17/09/2013 Pioglitazone USA 8 4 Tablets (page 122/Corr (as HCl) Valid up to 30mg 17/09/2018 Received Renewal Application 15/10/2012 Request for transfer Glimepiride of registration 34. 504719 Glimp Plus 2 2mg 22/10/2007 applied on Not Found 9 9 Tablets Pioglitazone 01/01/2014 but HCl 15mg deposited fee on 12/12/2013 the application shows date 06-12-2013 Applied on 19.10.2009 Request for transfer Pioglitazone of registration HCl 16.53mg applied on 35. 603585 Glitos 15mg US FDA eq. to 31/12/2004 01/01/2014 but 0 7 Tablet Pioglitazone deposited fee on 15mg 12/12/2013 the application shows date 06-12-2013
Applied on Pioglitazone 19.10.2009 HCl 33.06mg Request for transfer 36. 603585 Glitos 30mg eq. to 31/12/2004 of registration US FDA 8 Tablet Pioglitazone applied on 30mg 01/01/2014 but deposited fee on
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12/12/2013 the application shows date 06-12-2013
Applied on 19.10.2009 Request for transfer Pioglitazone of registration HCl 49.59mg applied on 37. 603585 Glitos 45mg eq. to 31/12/2004 01/01/2014 but US FDA 2 9 Tablet Pioglitazone deposited fee on 45mg 12/12/2013 the application shows date 06-12-2013
19/2/2011 USFDA Dimenhydrina 38. 601440 Gravinate Transfer of Reference te B.P. 14/10/1993 5 8 Injection registration attached 50 mg/ml (27)
Ibuprofen (B.P.) Received Renewal
39. 604223 Irofen Forte 400mg, 13/3/2006 Application India 9 3 Tablets Pseudoephedrin 03/03/2011
e HCl 60mg
Received Renewal Application 27/10/2010 Request for transfer Ibuprofen (B.P.) of registration 40. 703968 200mg, applied on Irofen Tablets 01/12/2005 US FDA 0 6 Pseudoephedrin 01/01/2014 but e HCl 30mg deposited fee on 12/12/2013 the application shows date 06-12-2013
Sitagliptin Phosphate Monohydrate 41. 707587 Jentin Met Valid up to eq. to Sitagliptin 18/4/2013 UK 1 Tablets 18/4/2018 50mg, Metformin HCl 1000mg
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Sitagliptin Phosphate Monohydrate 42. 707587 Jentin Met Valid up to eq. to Sitagliptin 18/4/2013 USA 2 2 Tablets 18/4/2018 50mg, Metformin HCl 500mg Received Renewal 43. 704224 Lamotrigin 13/3/2006 Application USFDA Lamnet Tablets 3 8 25mg 03/03/2011
Received Renewal 44. 704224 Lamotrigin 13/3/2006 Application USFDA Lamnet Tablets 4 9 50mg 03/03/2011
Received Renewal 45. 704225 Lamotrigin Application Lamnet Tablets 13/3/2006 USA 5 0 100mg 03/03/2011
Received Renewal Lamnet Application 46. 705311 Lamotrigin Chewable 5mg 10/11/2008 08/11/2013 US FDA 6 4 5mg Tablets Valid up to 08/11/2018 Received Renewal Application 29/04/2010 Valid up to Levofloxacin 29/04/2015 and Hemihydrate Request for transfer 47. 703916 Levoxin 750mg 768.70mg eq. 16/5/2005 of registration US FDA 9 0 Tablet to applied on Levofloxacin 01/01/2014 but 750mg deposited fee on 12/12/2013 the application shows date 06-12-2013
Valid up to 48. 807587 Lumark Levetiracetam 18/4/2013 18/4/2018 Not found 3 Injection 500/5ml
Received Renewal Escitalopram Application 49. 804224 Morcet 10mg 13/3/2006 (as Oxalate) 03/03/2011 US FDA 3 7 Tablet 10mg Valid up to 03/3/2016
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Received Renewal Application 50. 805032 Nezolid 600mg Linezolid 26/7/2008 23/07/2013 US FDA 5 5 Tablets 600mg Valid up to 23/7/2018 Received Renewal Application 51. 805032 Nezolid 100mg Linezolid 26/7/2008 23/07/2013 US FDA 6 6 Suspension 100mg/5ml Valid up to 23/7/2018 Paracetamol 52. 807351 Nuberol She 500mg, Valid up to 12/12/2012 Not Found 8 6 Tablets Pamabrom 12/12/2017 25mg
Received Renewal Olmesartan Application 53. 905073 Olesta 5mg Medoxomil 24/9/2008 23/09/2013 US FDA 0 5 Tablets 5mg Valid up to 23/09/2018
Received Renewal Olmesartan Application 54. 905073 Olesta 20mg Medoxomil 24/9/2008 23/09/2013 US FDA 6 Tablets 20mg Valid up to 23/09/2018
Received Renewal Olmesartan Application 55. 905073 Olesta 40mg Medoxomil 24/9/2008 17/09/2013 US FDA 2 7 Tablets 40mg Valid up to 17/09/2018 Valid up to Sodium chloride 29/11/2015 , Potassium Request for transfer chloride, of registration 56. 906711 Trisodium applied on Requires Peditral Liquid 29/11/2010 4 4 citrate 01/01/2014 but verification dihydrate, deposited fee on Dextrose, 12/12/2013 the Orange Flavor application shows date 06-12-2013
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Valid up to Sodium chloride 29/11/2015 , Potassium Request for transfer chloride, of registration 57. 906711 Trisodium applied on Requires Peditral Liquid 29/11/2010 5 3 citrate 01/01/2014 but verification dihydrate, deposited fee on Dextrose, 12/12/2013 the Regular Flavor application shows date 06-12-2013 Sodium chloride , Potassium chloride, Trisodium 58. 906711 Valid up to Requires Peditral Liquid citrate 29/11/2010 6 5 29/11/2015 verification dihydrate, Dextrose, Bubble gum Flavor Sodium chloride , Potassium chloride, 59. 906711 Trisodium Valid up to Requires Peditral Liquid 29/11/2010 7 6 citrate 29/11/2015 verification dihydrate, Dextrose, Banana Flavor Valid up to 03/05/2015 Sodium Request for transfer chloride, of registration 60. 906135 Peditral Low Potassium 03/5/2010 applied on Requires 8 1 Powder chloride, 01/01/2014 but verification Sodium Citrate, deposited fee on Dextrose 12/12/2013 the application shows date 06-12-2013 Received Renewal Application 29/04/2010 Valid up to 61. 903926 Drotaverine Relispa Tablets 01/6/2005 29/04/2015 9 2 HCl 40mg India Request for transfer of registration applied on 01/01/2014 but
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deposited fee on 12/12/2013 the application shows date 06-12-2013
Valid up to 15/12/2013 Request for transfer
of registration 62. Drotaverine India 05334 Relispa 15/12/2008 applied on 0 HCl Reference 4 Injection 01/01/2014 but 0 40mg/2ml attached deposited fee on (96) 12/12/2013 the application shows date 06-12-2013 Received Renewal Application 25/05/2009 31/7/2004 Valid up to
25/05/2014 15/09/2004 63. Request for transfer 03337 Athenil 40mg Simvastatin corrigendum for 0 of registration US FDA 0 Tablets 40mg correction in applied on registration 01/01/2014 but number deposited fee on
12/12/2013 the application shows date 06-12-2013 Received Renewal Application 29/04/2010 Valid up to 29/04/2015 64. Request for transfer 03926 Relispa Forte Drotaverine 01/6/2005 0 of registration 3 Tablet HCl 80mg India 2 applied on 01/01/2014 but deposited fee on 12/12/2013 the application shows date 06-12-2013
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Valid up to 07/09/2014 Request for transfer of 07/9/2009 registration applied 65. Drotaverine 05848 Relispa Forte on 0 HCl 21/3/2011 9 Injection 01/01/2014 but India 3 80mg/4ml correction in deposited fee on registration letter 12/12/2013 the application shows date 06-12-2013 Valid up to 05/10/2014 Request for transfer of registration 66. Rizone 05858 Ritodrine HCl applied on Discontinued 0 10mg/ml 05/10/2009 7 10mg 01/01/2014 but in USA 9 Injection deposited fee on 12/12/2013 the application shows date 06-12-2013 Valid upto 16/9/2014 Request for transfer Diclofenac of registration 67. Sodium 05852 16/9/2009 applied on Rotec/75 Tablet 75mg+ US FDA 3 01/01/2014 but Misoprostol deposited fee on 200mcg 12/12/2013 the application shows date 06-12-2013 02/1/2008 (page 238- Received Renewal 68. 239/Corr) Application 04738 Alfacalcidol Not found in Searl-α Tablets 29/4/2008 29/04/2013 2 0.25mcg UK as capsule 2 change of brand Valid up to name 29/04/2018
02/1/2008 Received Renewal (page 242- 69. Application 04738 Alfacalcidol 243/Corr) Not found in Searl-α Tablets 29/04/2013 3 1mcg 29/4/2008 UK as capsule 3 Valid up to change of brand 29/04/2018 name
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02/1/2008 Received Renewal (page 246- 70. Application 04738 Alfacalcidol 247/Corr) Not found in Searl-α Tablets 29/04/2013 4 0.5mcg 29/4/2008 UK as capsule 4 Valid up to change of brand 29/04/2018 name
Registration valid up to 01/4/2014 Request for transfer of registration 71. 05561 Serebal Mecobalamin 01/4/2009 applied on Japan 1 Injection 500mcg 01/01/2014 but 6 deposited fee on 12/12/2013 the application shows date 06-12-2013
Received Renewal Simvastatin10 72. Application 04404 mg, 11/9/2006 2 Simbex Tablets 27/6/2011 US FDA 8 Ezetimibe10m 7 Valid up to g 27/6/2016
Received Renewal Simvastatin 73. Application 04404 20mg, 11/9/2006 US FDA 2 Simbex Tablets 27/6/2011 9 Ezetimibe10m 8 Valid up to g 27/6/2016
Received Renewal Simvastatin 74. Application 04405 40mg, 11/9/2006 2 Simbex Tablets 27/6/2011 US FDA 0 Ezetimibe10m 9 Valid up to g 27/6/2016
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15/9/2006 Received Renewal (page 352/Corr) Application 75. 17/3/2007 04408 Uripas Tablets Doxazosin 2 27/06/2011 5 change of name US FDA 2 2mg mg Valid up to of Oxoso to 27/6/2016 Uripas
15/9/2006 Received Renewal (page 352/Corr) Application 76. 17/3/2007 04408 Uripas Tablets Doxazosin 27/06/2011 5 change of name US FDA 3 4mg 4mg Valid up to 2 of Oxoso to 27/6/2016 Uripas
Received Renewal Application 77. 04407 Rosuvastatin 14/9/2006 27/06/2011 US FDA 5 Vaptor Tablets 6 10mg Valid up to 3 27/6/2016
Received Renewal 78. Application 04407 Rosuvastatin 14/9/2006 US FDA 5 Vaptor Tablets 27/06/2011 7 20mg 4 Valid up to 27/6/2016
Received Renewal 79. Application 04407 Rosuvastatin 14/9/2006 US FDA 5 Vaptor Tablets 27/06/2011 5 5mg 5 Valid up to 27/6/2016
Reg. Renewal 19/10/2009 Valid up to Montelukast 19/10/2014 80. Sodium Request for transfer 03466 Ventek 10mg 23/11/2004 US FDA 5 10.40mg eq. to of registration 5 Tablets 6 Montelukast applied on Acid 10mg 01/01/2014 but deposited fee on 12/12/2013 the application shows
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date 06-12-2013
Received Renewal Montelukast Application 81. Ventek 4mg Sodium 4.16mg 03770 21/3/2005 25/2/2010 5 Chewable eq. to US FDA 3 Valid up to 7 Tablets Montelukast 25/2/2015 Acid 4mg
Applied on 03-08-2009 valid up to 03/10/2014 Request for transfer 82. 03404 Xadine 60mg Fexofenadine 29/9/2004 of registration 5 US FDA 5 Tablet HCl 60mg applied on 8 01/01/2014 but deposited fee on 12/12/2013 the application shows date 06-12-2013 Applied on 03-08-2009 valid up to 03/10/2014 Request for transfer 83. 03404 Xadine 120mg Fexofenadine 29/9/2004 of registration 5 UK 6 Tablet HCl 120mg applied on 9 01/01/2014 but deposited fee on 12/12/2013 the application shows date 06-12-2013 Applied on 03-08-2009 valid up to 03/10/2014 84. 03404 Xadine 180mg Fexofenadine 29/9/2004 Request for transfer US FDA 6 7 Tablet HCl 180mg of registration 0 applied on 01/01/2014 but deposited fee on 12/12/2013 the
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application shows date 06-12-2013
Received Renewal Application 26/04/2010 Valid up to Fexofenadine 26/4/2015 85. HCl 60mg, Request for transfer 03923 Xadine Plus 08/5/2005 Not found in 6 Pseudoephedr of registration 0 Tablet USA ine HCl 60 applied on mg 01/01/2014 but deposited fee on 12/12/2013 the application shows date 06-12-2013 Request for transfer of registration applied on UK 86. 05333 Piroxicam 15/12/2008 01/01/2014 but Reference 6 Xicom Injection 9 20mg/ml deposited fee on attached 2 12/12/2013 the (49) application shows date 06-12-2013 Valid Up to 1/4/2014 Duloxetine Request for transfer HCl enteric of registration 87. 05560 Zenbar 20mg coated pellets 01/4/2009 applied on US FDA 6 8 Capsule eq. to 01/01/2014 but 3 Duloxetine deposited fee on 20mg 12/12/2013 the application shows date 06-12-2013 Valid Up to 1/4/2014 Duloxetine Request for transfer HCl enteric of registration 88. 05560 Zenbar 30mg coated pellets 01/4/2009 applied on US FDA 6 9 Capsule eq. to 01/01/2014 but 4 Duloxetine deposited fee on 30mg 12/12/2013 the application shows date 06-12-2013
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Valid Up to 1/4/2014 Duloxetine Request for transfer HCl enteric of registration 89. 05561 Zenbar 60mg coated pellets 01/4/2009 applied on US FDA 6 0 Capsule eq. to 01/01/2014 but 5 Duloxetine deposited fee on 60mg 12/12/2013 the application shows date 06-12-2013 Valid up to 05/10/2014 Request for transfer of registration 90. Zulexa Depot Zulcopenthixo 05858 applied on UK 6 Injection l Decanoate 05/10/2009 5 01/01/2014 but 6 200mg/ml 200mg/ml deposited fee on 12/12/2013 the application shows date 06-12-2013 Valid up to 05/10/2014 Request for transfer of registration 91. Zulexa Depot Zuclopenthixo 05858 applied on UK 6 Injection l Decanoate 05/10/2009 6 01/01/2014 but 7 500mg/ml 500mg/ml deposited fee on 12/12/2013 the application shows date 06-12-2013 Received Renewal Application 25/02/2010 Valid up to Montelukast 25/2/2015 92. Ventek 5mg Sodium Request for transfer 03770 21/3/2005 6 Chewable 5.2mg eq. to of registration US FDA 4 8 Tablet Montelukast applied on Acid 5mg 01/01/2014 but deposited fee on 12/12/2013 the application shows date 06-12-2013 93. Lisinopril Valid Up to 07374 Zestoretic-10 23/1/2013 US FDA 6 Dihydrate 23/01/2018 2 Tablet 9 10mg +
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Hydrochlorot hiazide 12.5mg 11/2/2010 Valid Up to US FDA 94. Cefixime 1/10/2013 06244 Omixim 30/6/2015 Reference 7 (as trihydrate) (extension in 1 Capsule Till 30-06-2015 attached 400 mg contract M-238 (53) manufacturing
11/2/2010 Valid Up to US FDA 95. Cefixime 06244 Omixim 1/10/2013 30/6/2015 Reference 7 (as trihydrate) 2 Capsule (extension in Till 30-06-2015 attached 2 200 mg contract M-238 (53) manufacturing
11/2/2010 Valid Up to US FDA 96. Cefixime 06244 Omixim 1/10/2013 30/6/2015 Reference 7 (as trihydrate) 3 Suspension (extension in Till 30-06-2015 attached 3 100mg/5ml contract M-238 (93) manufacturing
11/2/2010 Valid Up to US FDA 97. Cefixime (as 06244 Omixim DS 1/10/2013 30/6/2015 Reference 7 trihydrate) 4 Suspension (extension in Till 30-06-2015 attached 4 200mg/5ml contract M-238 (93) manufacturing
Till 30-06-2015 (M-238) Ceftriaxone Applied for US FDA 98. 06243 Tefno Injection Sodium eq. to 11/2/2010 extension in Reference 7 8 1gram Ceftriaxone contract attached 5 1g manufacturing (52) permission on 24/1/2014
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Till 30-06-2015 (M-238) Ceftriaxone Applied for US FDA 99. 06243 Tefno Injection Sodium eq. to 11/2/2010 extension in Reference 7 9 500mg Ceftriaxone contract attached 6 500g manufacturing (52) permission on 24/1/2014 Till 30-06-2015 (M-238) Ceftriaxone Applied for US FDA 100. 06244 Tefno Injection Sodium eq. to 11/2/2010 extension in Reference 7 0 250mg Ceftriaxone contract attached 7 250g manufacturing (52) permission on 24/1/2014 101. Valid Up to 07602 Tizax 4mg Tizanidine 19/9/2013 US FDA 8 19/9/2018 2 Tablets 4mg 9
102. Valid Up to 07602 Tizax 2mg Tizanidine 19/9/2013 US FDA 9 19/9/2018 3 Tablets 2mg 0
The firm has submitted the following documents in support of its request:
a (ii)
Export Products for transfer of registration from Searle Pakistan Limited to "The Searle
Company Limited" Internation S. Brand Formulation / Date of Reg. No. Renewal Status al No. Name (s) Generic Name registration availability Received Renewal Application 19/03/2010 US FDA Valid up to Reference Diulactone Spironolactone 25/3/2005 19/3/2015 103 000332-Ex attached Tablets 25mg (3) Request for transfer
of registration applied on 01/01/2014 but
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deposited fee on 12/12/2013 the application shows date 06-12-2013
Received Renewal Application 19/03/2010 Valid up to 19/3/2015 US FDA Diulactone Spironolactone 25/3/2005 Request for transfer Reference 104 000333-Ex Tablets 100mg of registration attached applied on (3) 01/01/2014 but deposited fee on 12/12/2013 the application shows date 06-12-2013 Valid up to 20/4/2014
Sodium Chloride Request for transfer 2.60gm WHO of registration Peditral Low Potassium Chloride 20/4/2009 Reference 105 001218-EX applied on Powder 1.50gm attached 01/01/2014 but Sodium Citrate 2.90gm (4) deposited fee on Dextrose 13.50gm 12/12/2013 the application shows date 06-12-2013 Received Renewal Application 19/03/2010 Valid up to 19/3/2015
India Relispa Drotaverine HCl 25/3/2005 Request for transfer 106 000331-Ex Reference Tablets 40mg of registration attached applied on (5) 01/01/2014 but deposited fee on 12/12/2013 the application shows date 06-12-2013 Relispa Drotaverine HCl 25/3/2005 Received Renewal 107 000329-EX Injection 40mg/2ml Application India
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19/03/2010 Reference Valid up to attached 19/3/2015 (5)
Request for transfer of registration applied on 01/01/2014 but deposited fee on 12/12/2013 the application shows date 06-12-2013 Received Renewal Application 19/03/2010 Valid up to 19/3/2015
India Relispa Forte Drotaverine HCl 25/3/2005 Request for transfer 108 000330-EX Reference Tablet 80mg of registration attached applied on (5) 01/01/2014 but deposited fee on 12/12/2013 the application shows date 06-12-2013 Received Renewal Application 09/03/2010 Valid up to 9/3/2015 (page 463/Corr) USA Diquin Nalidixic acid 25/3/2005 Request for transfer Reference 109 000328-Ex Suspension 250mg/5ml of registration attached applied on (2) 01/01/2014 but deposited fee on 12/12/2013 the application shows date 06-12-2013 Levofloxacin Valid up to Serlev 250mg Hemihydrate 8/8/2012 US FDA 110 003507-EX 8/8/2017 Tablets 256.23mg eq. to
Levofloxacin 250mg
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Levofloxacin Valid up to Serlev 750mg Hemihydrate 8/8/2012 US FDA 111 003508-EX 8/8/2017 Tablets 768.70mg eq. to
Levofloxacin 750mg
Decision: Registration Board approved registration of above drugs in name of M/s The Searle Company Ltd., Karachi except following items: Items at S.No.6,7,10,15,22,63,87,95 and 96-101 for confirmation of renewal status Items at S.No.10,16,19,31,35,40,49,53,57-63,65-67,69-71 and 86 for confirmation of approval status by reference regulatory authorities.
Case No.19 Deferred cases:
a. Deferred in 241st meeting of Registration Board
Registration Board in M-241st meeting deferred the following products of M/s Kaizen Pharmaceutical (Pvt) Ltd, Plot No. E-127, E-128, E-129, North Western Industrial Zone, Bin Qasim, Karachi for the reasons stated in last column below:
1 Offpain plus Tablets Form 5 13-05-2013 Manufact Deferred for Each film coated tablet Fast Track 842 urer’s confirmation of contains: Diclofenac 10’s/As per PRC Rs.60,000 manufacturing and sodium (in enteric storage facilities of coated core) (USP) misoprostol by area ...50mg FID and Director Misoprostol(B.P)…… DTL, Karachi …..200mcg (NSAID with Synthetic Prostaglandin E1 analog)
2 Inofer-F Chewable Form 5 13-05-2013 Manufact Deferred for PSI for Tablets Fast Track 841 urer’s confirmation of Each chewable Tablet 10gm, 20gm, Rs.60,000/- manufacturing and contains: 30gm, 40gm, / testing facility by Iron (III) Hydroxide PRC Director CDL, Polymaltose Complex Karachi and area eq. to Elemental Iron FID. (M.S)….100mg Folic Acid (U.S.P)…0.35mg (Anti anaemic agent)
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Now the firm has intimated that an inspection has been carried out by Area FID, Karachi dated 28.01.2016. The firm has also provided a copy of inspection report. The inspection report mentioned that: “It is confirmed that firm has manufacturing facilities with all required storage conditions [cold, cool and room Temperature (below 25oC)] for oral tablet dosage form in their multiple dosage form manufacturing site. This confirmation verifies the readiness for particular product”.
The firm has requested for grant of registration
Decision: Registration Board approved registration of above products for M/s Kaizen Pharmaceutical, Karachi.
Case No.20 Registration of drugs approved in previous meetings.
a. Registration of product approved in M-236.
Registration Board in its 236th meeting approved the following products of M/s Kaizen Pharmaceutical (Pvt) Ltd, Plot No. E-127, E-128, E-129, North Western Industrial Zone, Bin Qasim, Karachi, subject to revision of sodium saccharin in formulation as per safe limits:
Inovel Dry Suspension 30ml As per PRC 08-11-2012 Each 5ml contains: 60ml Dy.No.1758 Artemether ……….…..15 mg 90ml Form-5 Lumefantrine………….90 mg Rs.20000/- (Anti Malarial) Inovel Plus Dry Suspension 30ml As per PRC 08-11-2012 Each 5ml contains: 60ml Dy.No.1757 Artemether …………...30 mg Form-5 Lumefantrine……..…180 mg Rs.20000/- (Anti Malarial)
Now the firm has submitted the revised formulation for the above products containing the sodium sachrine within FDA limits i.e. 3.33mg/5ml (0.65%). The firm has now requested for the grant of registration.
Decision: Registration Board approved registration of above products for M/s Kaizen Pharmaceutical (Pvt) Ltd, Plot No. E-127, E-128, E-129, North Western Industrial Zone, Bin Qasim, Karachi.
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b. Registration of product approved in M-197-A. Registration Board in its 197-A meeting approved the following product of M/s Semos Pharmaceutical (Pvt) Ltd., Plot No. 11, Sector 12-A, North Karachi Industrial Area, Karachi as per following detail: S.# Name of product with specification Demanded Demanded Decision of M- pack size price 197-A 1. Razole 20mg Tablet 1x10’s As per Approved Each film coated tablet contains: leader Rabeprazole Sodium……...20mg price
Now the firm has submitted the remaining fee @ Rs.12,000/- for above product and has requested for grant of registration of above product. Decision: Registration Board approved registration of above product as enteric coated formulation for M/s Semos Pharmaceutical (Pvt) Ltd., Plot No. 11, Sector 12- A, North Karachi Industrial Area, Karachi.
c. Registration of products approved in M-213. Registration Board in its 213th meeting approved the following products of M/s S.J & G Pharmaceutical, Karachi as per following detail: S.# Name of product with Demanded Demanded Decision Status in specification pack size price of M-213 reference agencies 1. Pamin 15mg Injection Vial Rs. Approved UK Each vial contains:- 1500.00 Disodium Pamidronate….15mg (Bone-resorption inhibitor)
2 Pamin 30mg Injection Vial Rs. Approved UK Each vial contains:- 2500.00 Disodium Pamidronate….30mg (Bone-resorption inhibitor)
3 Pamin 90mg Injection Vial Rs. Approved UK Each vial contains:- 5000.00 Disodium Pamidronate….90mg (Bone-resorption inhibitor)
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4 Bonzer 250mg Injection Vial Rs. 350.00 Approved Discontinued Each vial contains:- in US and Daptomycin….….250mg not available (Anti-bacterial) in UK
5 Bonzer 500mg Injection Vial Rs. 500.00 Approved US/FDA Each vial contains:- Daptomycin….….500mg (Anti-bacterial)
Now the firm has deposited Rs.12,000/- for each product and has requested for grant of registration of above products. Decision: Registration Board approved registration of above products for M/s S.J & G Pharmaceutical, Karachi except at S.No.04 for confirmatuion of approval status in reference regulatory authorities.
d. Registration of products approved in M-235th.
Registration Board in its 235th meeting approved the following product of M/s Macter International Limited, E-40A, SITE, Karachi subject to the condition mentioned in the last column.
Zocin Injection 2.25gm Per vial Rs.500.00 Approved Each vial contains:- subject to Piperacillin (as Sodium) ….2gm submission of Tazobactam (as Sodium)..250mg Labeling and (Antibiotics) prescribing information.
Now the firm has submitted the same. The firm have requested for grant of registration with the brand name of Tacip as their two strength 3.375gm and 4.5gm of same drug registered (Reg No.073631 and Reg No. 073632) with the brand name of Tacip.
Decision: Registration Board approved registration of above product for M/s Macter International Limited, Karachi with change of brand name as Tacip.
e) Registration of products approved in M-238th.
Registration Board in its 238th meeting approved the following product of M/s Macter International Limited, Karachi subject to the condition mentioned in the last column.
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Ciproquine OS 250mg/5ml 60ml Rs.210.00 Approved. The Suspension Board advised the Each 5ml contains:- firm to replace Ciprofloxacin as HCl…………250mg Sod. Cyclamate (Anti bacterial) and Sod. Saccharin in safe limits
The firm has informed that they have replaced Sodium cyclamate and Sodium saccharin by Sucralose. The firm has requested for issuance of registration letter. Decision: Registration Board deferred the case for evaluation in light of decision taken in 250th meeting.
Case No.21 Correction required in Registration.
M/s Kaizen Pharmaceutical (Pvt) Ltd, Plot No. E-127, E-128, E-129, North Western Industrial Zone, Bin Qasim, Karachi have requested for correction in the dosage of following already registered products. The details are as under: S.# Regn. No. Existing information Desired information 1. 073634 Respair Suspension Respair Syrup Each 5ml contains: Each 5ml contains: Terbutaline Sulphate….1.5mg Terbutaline Sulphate….1.5mg (manufacturer’s Specification) (manufacturer’s Specification) 076460 Revocal – D 400mg Syrup Revocal – D 400mg Suspension Each 5ml contains: Each 5ml contains: Ossein Mineral Ossein Mineral Complex………..400 mg Complex………..400 mg Vitamin D…………400 I.U Vitamin D…………400 I.U (Product complies (Product complies Manufacturer’s Manufacturer’s Specification) Specification)
The both drugs registered on 11th July, 2014 their renewal is not applicable. The product at S.no.01 is registered in UK in syrup dosage form while the s.no.02 is registered with number local manufacturers in suspension dosage form.
Decision: Registration Board advised to deposit requisite fee and Form-5 for consideration of their application.
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Case No. 22 Show cause notice/stop production order
The Secretary, Central Licensing Board, DRAP, Islamabad forwarded a case wherein, the Central Licensing Board in its 245th meeting considered the inspection report of M/s Rex Pharmaceutical Karachi conducted on 06.03.2013 by Mr. Abdul Rasool Sheikh, FID, Karachi. During inspection the FID pointed out a number of serious/critical shortcomings in all sections. Accordingly a show cause notice /stop production order was issued on 23.04.203. The case was presented before CLB in its 232nd meeting held on 29&30 July, 2013. The board decided as under:-
i. The case was deferred by Central Licensing Board till its next meeting as per your request that the Director of the firm had gone to Saudi Arabi for performing Umrah and requested to defer the case till next meeting of CLB. ii. The production will remain stopped / suspended till the final approval for resumption of production by the Central Licensing Board. The case was again presented before the 233rd Meeting of CLB, wherein the CLB had decided as under: “After thorough discussion and deliberations, considering the background of the case and facts on record, Board unanimously decided to suspend the DML of the firm for period of three months under rules 13 of Drugs (Licensing, Registering and Advertising) Rules, 1976. The Board further decided to issue show cause notice and personal hearing to the firm and advised for market survey of production manufactured by firm”. 3. The decision of the CLB was conveyed to the firm on 24.02.2014. The firm vide letter No. NIL dated 02.04.2014 replied that they have removed all the shortcomings and ready for inspection. The Area FID visited the firm on 18.11.2014 and recommended for cancellation of DML. The case was placed before the CLB in its 245th meeting held on 30.12.2015.
Proceedings of the 245th meeting of CLB The firm was provided opportunity of personnel hearing before the Board, but no representative appeared before the CLB, on behalf of firm. The Board showed displeasure on such non serious attitude of the company.
Decision of the 245th meeting of CLB I. The Board after thorough discussion, keeping in view the available record, observations of the FID in its inspection Conducted on 06.03.2013, track record and non serious attitude of the firm, and report of the FID dated 18.11.2014 which
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categorically stated that “The DML of the firm may be cancelled in larger public interest” has decided to suspend the DML of the firm M/s Rex Pharmaceuticals Pakistan, Karachi for a period of 06 months under rules 12 of the Drugs (LR&A) Rules, 1976. II. The Board further decided to verify the renewal status of DML from Licensing Division. Decision: Registration Board advised to issue show cause notice for suspension of registered products in name of M/s Rex Pharmaceutical, Karachi keeping in view status of their Drug Manufacturing License.
Case No. 23 Request for extension of contact manucaturing
M/s Medisure Pvt. Ltd. Karachi have applied for extension in the contract manufacturing permission of their following product which was valid upto 30-06-2015 as per following details.
S. Contract Reg. No. Name of drug(s) Date of Category Decision of M- No. manufacturer & Composition application, 238 meeting of Diary No. & Registration Form Board 1. M/s Surge Lab. 070763 Perasure 2gm 29-04-2013 Dedicated Extended till Sheikhuypura. Injection DyNo.299 facility 30.06.2015 Each vial Form-05 Cephalosporin contains: Rs.42,000/- Cefoperazone as Rs.8000/- sodium……1 gm 01-6-2009 Sulbactam as Sodium…1g 2. -do- 070762 Perasure12gm 23-04-2013 -Do- Extended till Injection DyNo.319 30.06.2015 Each vial Form-05 contains: Rs.42,000/- Cefoperazone as Rs.8000/- sodiu……500mg 01-6-2009 Sulbactam as Sodium…500mg 3. M/s Opal lab. 045029 Surexime 23-04-2013 -Do- Extended till Kar. Suspension DyNo.322 30.06.2015 Each 5ml Form-05 contains: Rs.42,000/- Cefixime..100 mg Rs.8000/- 29-6-2010
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4. -do- 045030 Surexime 400mg 23-04-2013 -Do- Extended till Capsule DyNo.321 30.06.2015 Each capsule Form-05 contains: Rs.42,000/- Cefixime...400 mg Rs.8000/- 29-6-2010 5. M/s PharmEvo 045228 Armasure 1gm IV 23-04-2013 -Do- Extended till Kar. Injection DyNo.320 30.06.2015 Each vial Form-05 contains: Rs.42,000/- Ceftriaxone as Rs.8000/- sodium……..1g 23-6-2010 6. -do- 045227 Armasure 500mg 23-04-2013 -Do- Extended till IV Injection DyNo.330 30.06.2015 Each vial Form-05 contains: Rs.42,000/- Ceftriaxone as Rs.8000/- sodium….500 mg 29-6-2010 7. -do- 045226 Armasure 250mg 23-04-2013 -Do- Extended till IV Injection DyNo.323 30.06.2015 Each vial Form-05 contains: Rs.42,000/- Ceftriaxone as Rs.8000/- sodium….250 mg 29-6-2010
The firm has deposited the fee of Rs. 50,000/- for each product. The firm firm has requested for correction in product at s. no. 2 wherein 12 gm has been typed with brand name instead of 1 gm. Similarly, for products at s. no. 5 to 7 they got the name change as Cefsure from Armasure. Decision: Registration Board approved extension in contract manufacturing of above products till 30.06.2020 in light of Rule 20A of Drugs (L R & A) Rules, 1976 with change in brand name of products at S.No.2, 5-7.
Case No. 24 Request for additional pack
Registration Board in its 252nd approved the change of registration of following product from M/s OBS Pharma, Karachi to M/s AGP, Pvt. Ltd. Karachi along with change of name from Vicopin to Mecovate.
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S. Name of product(s) & Approved Name of product(s) Reg. No. No. composition & composition 1. 055574 Vicopin 500mcg Tablet Mecovate 500mcg Tablet Each tablet contains: Each tablet contains: Mecobalamin……500mcg Mecobalamin……500mcg (Manufacturer’s specifications) (Manufacturer’s specifications) 2. 076211 Vicopin 500mcg/ml Injection Mecovate 500mcg/ml Injection Each ml contains: Each ml contains: Mecobalamin……500mcg Mecobalamin……500mcg (Manufacturer’s specifications) (Manufacturer’s specifications)
The product at s.no. 01 was registered in the of M/s OBS Pharma, Karachi in packing of 20’s and the same was issued to the M/s AGP Pvt. Karachi. Now the firm has pointed out that while applying for change of registration for above products they applied for packing of 100’s packs along with the 20’s pack in their original application. The Form-5 submitted by the firms also verifies the firm’s claim. The firm has now requested for the issuance of corrigendum for 100’s pack size for s.no.01.
Decision: Registration Board approved pack size of 100’s for Mecovate tablets.
Case No. 25. Request for inclusion of information pertaining to product license holder and exporter name in the registration letter Registration Board in its 254th & 256th meeting registered the following products in the name of M/s Martin Dow Ltd. Karachi from M/s Martin Dow Pharmaceuticals, Karachi. S.# Regn. Product name Renewal Meeting of Product License No. up to R.B in Holder & which Exporter name registration was granted 1. 014929 Dormicum 5ml Ampoule 28.06.2020 M-254th M/s F. Hoffmann- 1mg/ml La Roche Ltd. Each ml contains Basel, Switzerland Midazolam………….1mg (Manufacturer’s Specification) 2 001049 Rivotril Tablet 0.5mg 28.06.2020 M-256th -do- Each tablet contains: Clonazepam……..0.5mg 3 000584 Valium Ampoule 28.06.2020 M-256th -do- 10mg/2ml
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Each ml contains Diazepam………5mg 4 001047 Rivotril Drops 0.25% 28.06.2020 M-256th -do- Each ml contains Clonazepam…….0.25% 5 003626 Rivotril Tablet 2mg 28.06.2020 M-256th -do- Each tablet contains Clonazepam……..2mg The firm has now informed that since these products were registered for bulk import and local repacking and they applied for quota allocation. While processing their application for quota allocation they require inclusion of name of product license holder / exporter name in the letter of change registration of above product to their name as per details mentioned in the last column above. The firm has deposited Rs.5000/- for each product. Decision: Registration Board approved firm’s request for incorporatuion of name of Product License Holder and Exporter name for above registrations. Case No. 26. Combo pack – Osmolar ORS (Reg. No.0454416) with Zincat-OD Syrup (Reg. No.053094) – M/s Atco Laboratories, Karachi Registration Board in 252nd meeting rejected the following formulation in como pack since the firm could not provide the evidence of the same reference drug agencies. Now the firm has provided the evidence of recommendation of WHO for co-packing of following formulation since these two formulation are incompatible and show stability issues in one formulation..
S. No. Reg. No. Name of drug(s) & Composition Quantity in Combo Pack 1. 045416 Osmolar ORS Two sachets Each sachet contains:- Sodium Chloride BP ……….1.3g Potassium Chloride BP …….0.75g Sodium Citrate BP …………1.45g Glucose Anhydrous ………. 6.75g 2. 053094 Zincat – OD Syrup One pack of 60ml Each 5ml contains:- Elemental Zinc (as Zinc Sulphate Monohydrate USP) ……………….20mg
Firm has requested for re-consideration of above formulation in the combo pack by the Registration Board. The firm has not submitted the fee for reconsideration. Decision: Registration Board deferred case for complete previous status of case including personal hearing.
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Registration-V
Case No.27 Extension in Shelf life of Water for Injection in respect of M/s. NovaMed Pharma, Lahore
M/s. NovaMed Pharma, Lahore has applied for extension in shelf life of following product:-
S.No Name of drugs with composition Reg. No Approved Shelf Life 1. Water for Injection 05ml 076971 Two Year Each ampoule contains:- Sterilized Water for Injection….5ml 2. Water for Injection 10ml 076972 -do- Each ampoule contains:- Sterilized Water for Injection….10ml
Dr. Mehmood Ahmed of Islamia University Bahawalpur has furnished the expert opinion and recommended extension in shelf life. The case was also sent for expert opinion of Prof. Taufeeq Ahmed, Quaid-i-Azam International University, Islamabad and Mr. Ammanullah Khan, Member Registration Board, Director Drug Testing Laboratory, Quetta. However reply is awaited. Earlier, expert opinion of Director DTL, Karachi, Director DTL Quetta and Dr, Rafi-uz- Zaman, Member registration board was also obtained and they had also recommended the product for extension in shelf life. Initially this product was registered in 238th meeting of Registration board and 2 years shelf life was granted. The firm had submitted stability studies for extension in shelf life from 2 to 3 years as following details:-
No. of Batches 03 Batch Size 3000 Ampoules/Batch Storage condition WHO Zone-IV-A Testing Frequency 0,1,3,6 Time period 06 months accelerated 33 months real accelerated Testing para meters Description, Acidity or Alkalinity, conductivity, Oxidisable substances, chlorides, Nitrates, Sulphates, Ammonium, Calcium & Magnesium, Residue on Evaporation, Particulate Contamination, Bacterial Endotoxins,
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Sterility test.
According to ICH stability guidelines when the long term and accelerated data shows little or no change over time and little or no variability, the shelf life can be up to twice but should not be more than 12 months beyond the period covered by long term data. (ICH stability guideline 2.4.1.1). Decision: Registration Board discussed the case in the light of recommendations of the experts. Dr. Amanullah, Member Registration Board informed that he has already furnished comments and has recommended the product for extention in shelf life. Registration Board deliberated and decided to grant extention in shelf life from two to three years. It was further decided that the firm will submit real time stability studies upto the assigned shelf life approved by the Board.
Case No.28: Registration of drug in the name of Citi Pharma (Change of Title of Manufacturer. Registration Board in its 255th meeting deferred the following products for the confirmation of the validity of Registration:- S.No Registration Name of Drug (s) Fee Date of Date of Renewal Number Initial submitted Registration 1 030710 Avanol cough syrup Rs. 24.07.2003 15.06.2015 Each 5 ml Contains: 20,000/ Carbinaxamin Maleate powder ………2mg Ephedrine HCl…….7mg Phalcodine………….4mg 2 030711 Asovil Cough Syrup Rs. 02.08.2003 15.06.2015 Each 5 ml Contains: 20,000/ Aminophyllin…….32mg Diphenhydramin HCl powder. 8mg Ammonium chloride……30mg Menthol…….0.98mg 3 030712 Bestonic Syrup Rs. 24.07.2003 15.06.2015 Each 5ml contains: 20,000/ Vitamin B1……10mg Vitamin B2…….. 10mg Vitamin B6……..10mg Vitamin B12…….5mcg Calcium D Pentothenate…..3mg Vit. C……150mg Nicotinamide…….50mg Lysine Mono HCl………20mg
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4 030713 Avazin 10mg Tablet Rs. 02.08.2003 15.06.2015 Each tablet Contains: 20,000/ Cetirizine 2HCl……… 10mg 5 030714 Askprin 75mg Tablet Rs. 24.07.2003 15.06.2015 Each tablet Contains: 20,000/ Aspirin………. 75mg 6 030715 Askprin 150mg Tablet Rs. 24.07.2003 15.06.2015 Each tablet Contains: 20,000/ Aspirin………. 150mg 7 030719 Flurip 100mg Tablet Rs. 02.08.2003 15.06.2015 Each tablet Contains: 20,000/ Flurbiprofen………. 100mg 8 030720 Floxcip 250mg Tablet Rs. 24.07.2003 15.06.2015 Each tablet Contains: 20,000/ Ciprofloxacin HCl………. 250mg 9 030721 Floxcip 500mg Tablet Rs. 24.07.2003 15.06.2015 Each tablet Contains: 20,000/ Ciprofloxacin HCl………. 500mg 10 030723 Modopine 5mg Tablet Rs. 02.08.2003 15.06.2015 Each tablet Contains: 20,000/ Amlodipine Besilate…. 5mg 11 030724 Modopine 10mg Tablet Rs. 02.08.2003 15.06.2015 Each tablet Contains: 20,000/ Amlodipine Besilate…. 10mg 12 030725 Askprol Suspension Rs. 02.08.2003 15.06.2015 Each 5ml Contains: 20,000/ Paracetamol…… 120mg 13 030726 Askprol 500mg Tablet Rs. 02.08.2003 15.06.2015 Each tablet Contains: 20,000/ Paracetamol…. 500mg 14 030727 Askprol C Tablet Rs. 24.07.2003 15.06.2015 Each tablet Contains: 20,000/ Paracetamol……..325mg Dextromethorphen HBr…..10mg Chloropheneramine Maleate… 1mg Vitamin-C…….50mg Pseudo Ephedrine HCl…….. 30mg 15 030729 Duotec 150mg Tablet Rs. 24.07.2003 15.06.2015 Each tablet Contains: 20,000/ Ranitidine HCl………. 150mg 16 030730 Duotec 300mg Tablet Rs. 24.07.2003 15.06.2015
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Each tablet Contains: 20,000/ Ranitidine HCl………. 300mg 17 034988 Rocoz 10mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Simvastatin………. 10mg 18 034989 Rocoz 20mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Simvastatin………. 20mg 19 034990 Rocoz 40mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Simvastatin………. 40mg 20 034994 Lopec-H Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Losartan Potassium………. 50mg Hydrochlorothiazide………. 12.50mg 21 034995 Ponfab 250mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Mefanamic Acid………. 250mg 22 034996 Ponfab 500mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Mefanamic Acid………. 500mg 23 034987 Ponfab Suspension Rs. 13.12.2004 15.06.2015 Each 5ml Contains: 20,000/ Mefanamic Acid………. 50mg 24 034997 Promy 20mg Capsule Rs. 13.12.2004 15.06.2015 Each Capsule Contains: 20,000/ Omeprazole Pellets………. 20mg 25 034998 Lopec 50mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Losartan Potassium………. 50mg 26 034999 Lopec 100mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Losartan Potassium………. 100mg 27 035000 Cingol 5mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Montelukast as Sodium………. 5mg 28 035201 Cingol 10mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Montelukast as Sodium………. 10mg
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29 035202 Cefask 400mg Capsule Rs. 13.12.2004 15.06.2015 Each Capsule Contains: 20,000/ Cefixime ………. 400mg 30 035203 Cefask Suspension Rs. 13.12.2004 15.06.2015 Each 5ml Contains: 20,000/ Cefixime ………. 100mg 31 034983 Diaglim 1mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Glimipiride………. 1mg 32 034984 Diaglim 2mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Glimipiride………. 2mg 33 034985 Diaglim 3mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Glimipiride………. 3mg 34 034986 Diaglim 4mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Glimipiride………. 4mg 35 034991 Clopeg 75mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Clopidogril Bisulphate ………. 75mg 36 034992 Lenon 250mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Levofloxacin as Hemihydrate ….. 250mg 37 034993 Lenon 500mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Levofloxacin as Hemihydrate ….. 500mg 38 030728 Nimcox 100mg Tablet Rs. 02.08.2003 15.06.2015 Each tablet Contains: 20,000/ Nimesulide ….. 100mg
The Registration Board in 246th meeting approved the following SOPs for cancellation of registration from previous name of registration in new name of the firm. Registration Board deliberated on the matter and it was decided that following procedure will be adopted for these cases. “Registration will be cancelled from name of existing registration holder. The applicant will comply all requirements for grant of registration and then registration Board will decide the case for grant of registration keeping in view safety, efficacy and quality parameters”. Registration of drug when title of firm has been changed by firm and approved by Central Licensing Board (manufacturing site remains the same). Registration Board discussed that in this case registration will not be cancelled from previous name as there is no change in manufacturing site and only title of registration
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holder has been changed. Thus case will be processed for change of title of the firm and firm will submit following documents. a. Application on Form-5 with required fee as per relevant SRO. b. Copy of registration letter and renewal status. c. NOC for CRF clearance. d. Approval of new name / title from CLB. e. Undertaking that the formulation, API source & Specifications, manufacturing process, analytical test methods, release & shelf life specifications have not been changed.
Furthermore, the Registration Board in its 252nd meeting decided the case of Pharmawise as under:- “Registration Board discussed that decision of the Board in 164th meeting (2001) did not refer to any provision in the Drug Act, 1976 and relevant laws for payment of transfer fee for each product registered after the payment of fee for changing of title of the firm. Registration Board discussed the legal position in detail and decided as follows:
a. No fee will be charged for registration of products in new title of the firm (approved by CLB) if there is no change in management and manufacturing site of the firm. If the Federal Government desire to prescribe fee for each registered product with the change of the title of firm, then rules shall be amended accordingly. b. Applicant will deposit the requisite fee for registration of products in new title of the firm (approved by CLB) if there is either change in management or manufacturing site of the firm”. It is submitted that the renewal of license was granted on 28-06-2015 and they have applied for the change of title of manufacturing of the aforesaid products on 15-06-2015. Furthermore, the renewal section informed that firm has applied for the renewal of products at Sr. 20, 21 & 26 after the date of expiry. So the registration of these 03 products are not valid and renewal of rest of the products is not confirmed till now
Regsitration board in its 256th meeting discussed the case and decided as follows:
Decision (256th meeting): Registration Board deferred the request of the firm for further deliberations and confirmation of renewal status of other products except S.No. 20,21 and 26.
Decision: Registration Board was apprised that the firm has applied for renewal of their products with fee of Rs: 10,000/- product but after expiry of renewal period. Therefore, registrations of the firm are not valid. Registration Board discussed the case and it was decided to provide opputunity of personal hearing to the firm to explain their case before the Board.
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Case No.29: Stability data of new formulations approved in 243rd meeting.
Registration Board noticed that in 243rd meeting, new formulations were approved without condition of submission of stability data, although it was required for this purpose. Registration Board decided that stability data submitted by the firm will be presented in fortrhcoming meeting along with other such cases.
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Registration-II Case No. 30: Deferred for confirmation of formulation in reference countries. Karachi Registration Board in its 254th meeting deferred following products of M/s Macter Internation Karachi for confirmation of approval status of these formulation in the reference drug agencies as per following details:
S.No. Name of drug(s) & Demanded Demanded Date of Decision of Composition pack size Price application, R.B in 254th Diary No. & meeting Form 1 Venticort Rotacaps Not Rs.10/- 13-06-2012 Deferred 100mcg+6mcg mentioned Per cap Dy.No.1123 request of Capsule Form-5 firm for Each capsule contains: Rs.8000/- confirmation Budesonide….…100 mcg Rs.52,000/- of approval Formoterol fumarate 23-1-2013 status by dihydrate………….6 mcg reference (Corticosteroid / B-agonist) drug regulatory authorities 2 Venticort rotacaps Not Rs.15/- 12-06-2012 -do- 200mcg+6mcg mentioned Per tab Dy.No.1079 Each capsule contains: Form-5 Budesonide…….…200 mcg Rs.8000/- Formoterol Fumarate Rs.52,000/- dihydrate………….6 mcg 23-1-2013 (Corticosteroid) 3 Venticort rotacaps Not Rs.20/- 12-06-2012 -do- 400mcg+6mcg mentioned Per tab Dy.No.1080 Each capsule contains: Form-5 Budesonide……400 mcg Rs.8000/- Formoterol Fumarate Rs.52,000/- dihydrate……..….6 mcg 23-1-2013 (Corticosteroid)
Now the firm has provided the evidence of approval of formulation at s.no. 1&2 in UK, Australia and Switzerland. While the product at s.no.03 has not been found in the reference agencies by the firm. The firm has therefore requested that in lieu of s.no. 03 the may be granted approval of Venticort 400+12 (Budesonide + Formeterol 400+12 mcg) which is new drug and they have already applied on Form-5 D.
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Decision: Registration Board approved products at S.No.1 and 2 for registration in favor of M/s Macter Internation Karachi and deferred product at S.No.03 for confirmation of approval status in reference regulatory authorities.
Case No. 31: Reign Pharmaceutical, Karachi.
Registration Board in 235th meeting deferred following products being new formulation. Now firm has requested to grant registration of these products either as drugs or Health & OTC product.
Prozinc Syrup 30 ml Rs.8/- 12-9-2012 Deferred Each 5 ml Contains: 60 ml Per 5ml 1576 being new Zinc Gluconate 90 ml From -5 formulation (elemental Rs.8000/- zinc)……………. 20 mg Copper Sulphate (elemental Copper)…………..1mg (Astringent / Mineral)
Aqua-z-Lyte Syrup 300 ml Rs.12/- 12-9-2012 Deferred Each 100ml contains: 500 ml Per 100ml 1578 being new Sodium Chloride 600 ml From -5 formulation .….0.26g Rs.8000/- Trisodium Citrate Dihydrate………….. 0.29g Potassium Chloride...0.15g Glucose …………….1.35g Zinc Gluconate(elemental zinc)….. 3.33mg (Electrolytes/Zinc)
Decision: Registration Board deferred case for confirmation of approval status by reference regulatory authorities for registration purpose. Moreover, for Health & OTC product, firm should contact relevant Division for processing of case.
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Case No.32 Manufacturing requirement of Diclofenac Sodium Injection
Dr. Obaid Ali FID Karachi has written letters to the Chairman of DRB and chairman CLB on manufacturing of Diclofenac Sodium Injection with risk on safety, quality and efficacy. He has referred to the accepted principal that sterile drugs should be manufactured by aseptic Processing only when Terminal Sterilization is not feasible. Heat sensitivity of the product and instability at temperature required for sterilization need to be established prior to choosing aspetic processing to manufacture a sterile product. Where a choice is made not to utilize a method of terminal sterilization, proper scientific explanation and justification to prove that drug is heat sensitive and unstable is required. Heat liability of packaging materials should not itself be considered as adequate justification for not utilizing terminal sterilization for otherwise heat stable products. He has further informed that manufactures of subjected product namely M/s. Abbott, AGP and Barrett Hodgson were given multiple opportunities to come up with any justification that provides space or allow to manufacturer subjected product in an aseptic environment. Finally, they agreed on principal and regretted that they do not have any regulatory reference for the option they were using. Manufacturers of subjected product namely M/s. Searle & Asian Continental upon pursuance confirmed that they do not monitor and hence control potential and reported temperature induced degraded product Indoline derivative [1-(2,6-dicholorophenyl) indoline-2- one] in their finished dosage form and now they are fully aware that this degrade needs to be controlled and monitored for each batch. Both groups stated above were found manufacturing and distributing of product under question with the level of risk that is otherwise controlled in the interest of patient safety and consistent with the norms of regulatory science. FID Karachi has requested to look at all the manufacturer for the subject and bring the matter in the upcoming meeting of Board on priority. Our timely decision will protect our public. Decision: Registration Board decided to write a letter to the firms pointed out by FID Karachi and Diclofenac sodium brand leaders i.e. M/s.Novartis, M/s.Sami Karachi, PPMA and Pharma Bureau for their technical opinion.
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Case No.33 Revision of Check List and Prescribed Forms, 5, 5-A, 5-B, 5-D, 5-E Applications for registration of drugs are applied on prescribed forms 5, 5-A, 5-B, 5-D and 5-E. Registration Board in its 251st meeting reviewed the evaluation process and approved guidelines for evaluation of applications submitted in form 5. S # Form 5 Procedure to be adopted 1. Name and address of the manufacturer - (applicant) 2. Brand (Proprietary) name of Drug - 3. The chemical name(s) and, as appropriate - and available the established (generic) names and synonyms of the drug. 4. Strength of active ingredient(s) per unit, - e.g. each tablet or 5 ml, etc. contains 5. Pharmacological group. - 6. Recommended clinical use. Commitment to follow innovator brand or as approved by any reference regulatory authority (as approved in 249th meeting) and only such information shall be mentioned in medical literature/ patient information leaflet. This condition shall also be mentioned in registration letter. 7. Proposed route of administration. Commitment to follow innovator brand or as approved by any reference regulatory authority (as approved in 249th meeting) and only such information shall be mentioned in medical literature/ patient information leaflet. This condition shall also be mentioned in registration letter. 8. Proposed dosage. Commitment to follow innovator brand or as approved by any reference regulatory authority (as approved in 249th meeting) and only such information shall be mentioned in medical literature/ patient information leaflet. This condition shall also be mentioned in registration letter. 9. Proposed shelf life of the drug As per commitment (max 2 years). 10. Proposed storage conditions of finished Commitment to follow innovator brand or as product. approved by any reference regulatory authority (as approved in 249th meeting) and only such information shall be mentioned in medical literature/ patient information leaflet. This condition shall also be mentioned in registration letter. 11. Unit price of the drug, e.g. per tablet, per - capsule, per 5ml, etc. 12. In case of international availability, provide - the following information, namely:- a. name of the drug; b. country where sold / Minutes for 257th Registration Board Meeting 463
registered; and c. name of company selling the drug or having registration to manufacture (include supporting documents/proof of International registration. 13. Brand name(s) of drug available in - Pakistan. 14. Name(s) of company(s) manufacturing in - Pakistan. 15. Composition (actives & excepients) Commitment for following: including statement of the quantitative Pharmaceutical product development (before sale of composition, giving the weight or measure drug) in line with the compostion of innovator or for each active substance used in the any other generic approved by any reference manufacture of the dosage form. regulatory authority. For excepients, equivalent alternates can be used. No banned excipient shall be used. All excipients are required to be of pharmaceutical grade and within safe limits.
16. Outline of method of manufacture. Flow chart is required 17. Persons under whose direct supervision As per information provided by the firm and control the drug is manufactured with the following details, namely:- a. total number of technical staff; and b. name, qualification and designation of the persons directly supervising the manufacture of the drug applied for registration, and any change shall be properly documented and record maintained by the manufacturer. 18. Name of equipment that will be used in the As per information provided by the firm according to manufacture of the drug applied for the applied dosage form of the drug registration 19. Full descriptions of the specifications and Commitment for complying Drug Specification Rules, analytical methods necessary to assure the 1978 and validaton of analytical methods (before sale identity, strength, quality, purity and of drug) to assure the identity, strength, quality, purity homogeneity throughout the shelf life of and homogeneity throughout the shelf life of the drug the drug product. product.
20. Name, qualification and designation of the As per information provided by the firm. persons who will be responsible for the quality control of the drug. 21. Description of the equipment to be used for As per information provided by the firm according to the quality control of the active raw the applied dosage form of the drug. material and the finished products. 22. Labeling and prescribing information ( to Commitment to follow innovator brand or as be mentioned on the pack/leaflet) specimen approved by any reference regulatory authority (as or draft shall be submitted for the approved in 249th meeting) and only such following class as of drugs, namely:- a. information shall be mentioned in medical literature/ C.N.S. stimulants; b. drugs affecting patient information leaflet. uterine motility; c. drugs inhibiting This condition shall also be mentioned in
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hormonal production; d. hormones and registration letter. other steroidal preparation excluding preparations for external and topical use; e. narcotic drugs as per Single Convention on Narcotic Drugs 1961; and f. psychotropic substances mentioned as per convention on psychotropic substances, 1971. (Specimen of label to be submitted as soon as production starts) 23. Facility of water processing with As per Licensing section’s approval / GMP report / specifications. information provided by thr firm 24. Environment control processing with As per Licensing section’s approval / GMP report / details. information provided by thr firm 25. Type of container/packaging. As per innovator / approved by any reference regulatory authority (as approved in 249th meeting). 26. A copy of last Inspection Report conducted - by the DRAP. 27. Undertaking that the above given - information is true and correct to the best knowledge and belief of Production Manager & Quality Control Manager.
PPMA in a meeting with chairman and CEO of DRAP has requested to revisit the check lists and prescribed forms. The representative of the Ministry of Human Rights and Law division suggested to devise a committee to give its guidelines and to propose forms which are not contradictory to the ACT and rules frame there under. Decision: Proposed check list for scrutinization of registration applications (in line with relevant rules) was circulated during the meeting and Registration Board decided to deliberate the matter along with Forms 5, 5-A, 5-B, 5-D and 5-E.
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Case No.34 Application referred by Pharmaceutical Evaluation Cell. Applications of Sofosbuvir (Muhammad Amin: (DDC PEC-II) S/N Name and Brand Name Type of Remarks on Decision address of (Proprietary name + Form the manufacturer / Dosage Form + Initial date, formulation (if Applicant Strength) diary any) including Composition Fee International Pharmacological including status in Group differential stringent drug Finished product fee regulatory Specification Demanded agencies / Price / Pack authorities size Me-too status GMP status as depicted in latest inspection report (with date) by the Evaluator 613. Importer Osbuvir 400mg Form 5 Sovaldi USA Deferred for M/s. Kaybee tablet Dairy No. valid Drug Importer Each film coated 18 Sovaldi Sale License Enterprises, tablet contains: Dated 12- Ferozsons 11/1 Punjab Sofosbuvir ……. 01-2016 Pakistan Same Town, Gidumal 400mg Rs.100,000/- manufacturer 2 products Street off verily (Anti-Hep-C) As per road, Karachi (Manufacturer specs) approved price Manufacturer, EUROPEAN EGYPTIAN PHARMA. IND. CO. (EEPI), Km25 Alexandria- Cario desert road, Amriya, Alexandria- Egypt
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Stability data has been provided for the below mentioned applicants discussed above. a. M/S KAYBEE ENTERPRISES KARACHI
Drug Osbuvir tablets (Sofosbuvir) 400 mg Name of Manufacturer European Egyptian Pharmaceuticals industries Egypt Source API CAD middle East Pharmaceutical Industries LLC KSA Riyadh Storage Condition Real Time: 30 C and 75% RH Accelerated: 40 C and 65% RH Time Period Real Time: 9 months Accelerated: 6 months Frequency 0, 3, 6, 9 months Batch Size 125,020 tablets / batches. No. of Batches 03 Sample Size Not available Remarks. It seems that the firm has provided stability data of their locally manufacturer product. Further, testing frequency is not as per recommendation of the board finalized in 251st meeting.
Sr. No. Documents to be provided Status (M/S KAYBEE ENTERPRISES KARACHI) 8. COA of API Yes 9. Approval of API by regulatory authority of country of No origin or GMP certificate of API manufacturer issued by regulatory authority of country of origin. 10. Protocols followed for conduction of stability study and Yes details of tests. 11. Data of 03 batches will be supported by attested Yes respective documents like chromatograms, laboratory reports, data sheets etc. 12. Documents confirming import of API etc. Not applicable 13. All provided documents will be attested (name, sign and No stamp) for ensuring authenticity of data / documents. 14. Commitment to continue real time stability study till Yes assigned shelf life of the product.
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614. Importer Ledvir 90mg/400mg Form 5 Harvoni USA Approved M/s. AGP tablet Dairy No. as per (Private) Each film coated 141 Harvoni import Limited tablet contains: Dated 2-03- Ferozsons policy Importer B-2, Sofosbuvir ……. 2016 Pakistan S.I.T.E, 400mg Rs.100,000/- Karachi Ledipasvir……..90mg 30% less (Anti-Hep-C) than Manufacturer, (Manufacturer specs) originator Mylan price Laboratories 28’s limited, F-4 & F-12, MIDC, Malegaon, Sinnar, Nashik, 422 113, Maharashtra, India.
2. M/S AGP (Private Ltd, Karachi)
Drug Ledvir tablets (Sofosbuvir+Ledipasvir) 400 mg+90mg Name of Manufacturer Mylan Labs India Source API Its not clear weather Mylan labs india is the manufacturer of API or there is some other source of API. Storage Condition Real Time: 30 C and 75% RH Accelerated: 40 C and 65% RH Time Period Real Time: 6 months Accelerated: 6 months Frequency 0, 1,3, 6, months Batch Size 12,000 tablets. No. of Batches 03 Sample Size 42 packs Remarks Testing frequency is not as per recommendation of the board finalized in 251st meeting.
Sr. No. Documents to be provided Status (AGP (Private Ltd) Karachi 1. COA of API Yes 2. Approval of API by regulatory authority of country of No origin or GMP certificate of API manufacturer issued by regulatory authority of country of origin. 3. Protocols followed for conduction of stability study and Yes details of tests. 4. Data of 03 batches will be supported by attested Yes
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respective documents like chromatograms, laboratory reports, data sheets etc. 5. Documents confirming import of API etc. Not applicable 6. All provided documents will be attested (name, sign and Yes stamp) for ensuring authenticity of data / documents. 7. Commitment to continue real time stability study till Yes assigned shelf life of the product.
615. Importer HepCvirb 400mg Form 5 Sovaldi USA Deferred for M/s. AJ Mirza tablet Dairy No. clarification of Pharma (Private) Each film coated 334 Sovaldi following: Limited, 7- tablet contains: Dated 6-10- Ferozsons Ground Floor, Sofosbuvir …. 400mg 2015 Pakistan The sample Shafi Court, (Anti-Hep-C) Rs.100,000/- size used in Merewether (Manufacturer specs) testing. Road , Civil Sole agency Lines, agreement. Karachi Firm has attached the Manufacturer, photocopy of Cipla Ltd, COPP Cipla House, although Peninsula legalized by Business Park, Embassy. Ganpatrao Kadam Marg, Batch sizes. Lower Parel, Raw data Mumbai 400 including 013, India. chromatogra ms are not attached.
Source of raw material.
Inspection report conducted within the period of 1 year not attached.
There is more than 5% variation
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in the dissolution.
Stability tests are not signed by the technical personnel QCM &PM.
616. Importer Gratisovir 400mg Form 5 FDA. Sovaldi Deferred for: M/s. New Nest tablet Dairy No. 400mg by M/s submission Pharmaceuticals, Each film coated 594 Gilead of 1/6-P, Block6, tablet contains: Dated 29- differential PECHS, Karachi Sofosbuvir ……. 12-2015 Local. Sovaldi fee as 400mg Rs.50,000/- 400mg by M/s product is (Anti-Hep-C) Ferozsons me-too. Manufacturer, (Manufacturer specs) Drug sales license. European Egyptian Sole agency agreement. Pharma, IND, Complete Co. (EEPi), Km Specs and 25, Alexandria- method of Cairo Desert excipients is Road, Amriya required. Stability data of three batches of 125000 tablets submitted but supporting documents as decided by the board in 251st meeting not provided. Further testing frequency is also not according to requirements of the board. COPP shows that the license holder is not
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the manufacturer of the product. Clarification required in this regard.
Stability Data M/s Schazoo Pharmaceuticals Pvt Ltd.
Drug Lavie 400mg tablets (Sofosbuvir) Source Not provided Storage Condition Accelerated: 40°C and 75% RH Time Period Accelerated: 06 months Frequency 0,1,2,3,4,6,8,12,16,20,24,26,weeks Batch Size 1000 Tablets / batch No. of Batches 03 Sample Size 448 tablets Meeting Deferred in 252nd meeting of Registration Board for Lab scale scientifically rationale stability data & Latest GMP inspection report. Remarks Firm has not provided latest GMP inspection report. Further stability data for real time has not been provided. Clarification required weather the firm has utilized 448 tablets at one interval or collectively 448 tablets have been used in six months. N.B: Significant change in the assay of one batch has been noticed.
Documents / Data provided by the applicants (M/s Schazoo Pharmaceuticals Pvt Ltd, Lahore.)
Sr. No. Documents to be provided Status
1. COA of API No 2. Approval of API by regulatory authority of country of No origin or GMP certificate of API manufacturer issued by regulatory authority of country of origin. 3. Protocols followed for conduction of stability study and No details of tests. 4. Data of 03 batches will be supported by attested Yes (However, data respective documents like chromatograms, laboratory for only accelerated
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reports, data sheets etc. studies provided)
5. Documents confirming import of API etc. No
6. All provided documents will be attested (name, sign and Yes stamp) for ensuring authenticity of data / documents. 7. Commitment to continue real time stability study till No assigned shelf life of the product.
EVALUATION OF STABILITY DATA
Registration Board in its 255th meeting discussed the cases of stability studies submitted by the different applicants and observed that the stability data needs to be evaluated keeping in view characteristics of individual API / Molecule. Therefore, it was decided that in future all stability data submitted by the firms shall be evaluated by the committee comprising Dr. Aman Ullah Member Registration Board, Dr. Saifur Rehman Khatak Federal Government Analyst and In charge PEC. Recommendations of this committee shall be placed before the Board for consideration. Therefore, all the cases were deferred and stability data was referred for evaluation of the committee. Decision: Registration Board observed that the memebers of committee are based at different stations therefore communication could be a problem during evaluation process. Moreover, Board also discussed that as on site inspection is required to investigate the authenticity/genuineness of data (import of raw material, manufacturing and quality control facilities and stability data submitted for registration), thus it was decided that initial evaluation of stability data for new drug applications/ fomulations shall be evaluated by a committee comprising Incharge PEC and DDC (PEC).
Deferred application of M/s AG&C, Karachi.
Following applications of M/s AG&C Karachi were deferred by registration board in its 254th meeting: S/N Name and address Brand Name Type of Form Remarks on the Remarks by of manufacturer / (Proprietary Initial date, formulation (if Evaluator Applicant name + Dosage diary any) including Form + Fee including International Strength) differential fee status in stringent Composition Demanded drug regulatory Pharmacological Price / Pack agencies / Group size authorities Finished product Me-too status Specification GMP status as depicted in latest
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inspection report (with date) by the Evaluator
617. M/s Ali Gohar SYSTANE Ultra Form-5A The product is Deferred for & Co (Pvt) Lubricant Eye Dy No :160 not licensed in confirmation Limited, State Drops dated 23-04- the USA, of me-too Life Building Polyethylene 2011 however status. If No. 1B I.I. Glycol 400, 15000/- available in the product is me- Chundrigar NF……0.4% dated 23-04- market. The too, Road, Karachi Propylene 2011 COPP states that applicant shall Alcon glycol….0.3% 35000/- “such over the submit Laboratories Artificial tears dated 26-03- counter products differential Inc. 6201 Manufacturer 14 marketed fee of Rs. South Rs. 921/- without prior 50000/-. Freeway, Fort 10ml bottle clearance to this Worth Texas administration”. USA Me-too status not confirmed. 618. Applicant PATADAY Form-5A Alcon Labs, Deferred for M/s Ali 0.2% Dy. No. 29 USA. (US FDA) complete fee Gohar Each ml of dated 02-03- Me-too: as product is & Co (Pvt) sterile 2010 me-too in the Limited, State ophthalmic 15,000/- country. Life Building solution dated No. 1B contains: 02-03-2010 I.I Olopatadine 35,000/- Chundrigar HCL 2.22mg dated Road P.O. equivalent to 26-03-13 Box Olopatadine… Rs. 904/- 5167 Karachi. …..2mg Pack of 4ml Manufacture Anti-allergic Bottle r Manufacturer containing Alcon 2.5ml of Laboratories, solution Inc 6201 South Freeway, Fort Worth, Texas 76134, USA
The firm has now submitted that Systane Ultra Lubricant Eye Drops is not me-too therefore fee of Rs: 50000 already paid is applicable on this product. However, for Pataday Optalmic solution 0.2% differential fee of Rs: 50,000/- has been paid on Dec 28, 2015 vide deposit slip no. 0275369. Decision: Registration Board approved both the products i.e. Systane Ultra Lubricant Eye Drops and Pataday 0.2% sterile ophthalmic solution for registration.
Minutes for 257th Registration Board Meeting 473
Deferred application of M/s Shawan Pharma, Rawat.
Following applications of M/s Shawan Pharma, Rawat were deferred in 254th meeting of the board for confirmation of approval status by reference drug regulatory authorities. It is submitted that internationally, gabapentin 100 mg tablet is not available in this strength in reference authorities. However, 100 mg capsules are available. For rest of the products typographic error was made as original application of the firm was for gabapentin 300 mg and 400 mg capsules instead of tablets. Both the products are available internationally in the form of capsules.
S/N Name and Brand Name Type of Remarks on the Remarks by Decision address of (Proprietary name + Form formulation (if Evaluator manufacturer / Dosage Form + Initial any) including Applicant Strength) date, diary International Composition Fee status in Pharmacological including stringent drug Group differential regulatory Finished product fee agencies / Specification Demanded authorities Price / Me-too status Pack size GMP status as depicted in latest inspection report (with date) by the Evaluator 619. M/s Shawan Gatin 100mg Tablet Form-5 Internationall Deferred for Rejected Pharmaceuticals, Tablet Dy. No: y not confirmation as the Plot No. 37, Each Tablet contains: Not available in of approval product is Road NS-1, Gabapentin……100mg mentioned. this strength status by not approved National Gaba analogue dated 30- in reference reference by Industrial Zone (USP Specs) 07-2011 drug authorities. reference Rawat. 8000/- 100 mg regulatory drug Rawalpindi. 12,000/- capsules are authorities. regulatory dated 04- available. authorities 11-2013 Parketin of As per M/s Pfizer SRO / Karachi. 1x10’s
Minutes for 257th Registration Board Meeting 474
620. M/s Shawan Gatin 400mg Tablet Form-5 Internationall Deferred for Approved Pharmaceuticals, Tablet Dy. No: y not confirmation Plot No. 37, Each Tablet contains: Not available in of approval Road NS-1, Gabapentin……400mg mentioned. this strength status by National Gaba analogue dated 30- in reference reference Industrial Zone (USP Specs) 07-2011 authorities. drug Rawat. 8000/- 100 mg regulatory Rawalpindi. 12,000/- capsules are authorities. dated 04- available. 11-2013 Parketin of As per M/s Pfizer SRO / Karachi. 1x10’s
621. M/s Shawan Gatin 300mg Tablet Form-5 Internationall Deferred for Approved Pharmaceuticals, Tablet Dy. No: y not confirmation Plot No. 37, Each Film Coated Not available in of approval Road NS-1, Tablet contains: mentioned. this strength status by National Gabapentin……300mg dated 30- in reference reference Industrial Zone Gaba analogue 07-2011 authorities. drug Rawat. (USP Specs) 8000/- 100 mg regulatory Rawalpindi. 12,000/- capsules are authorities. dated 04- available. 11-2013 Parketin of As per M/s Pfizer SRO / Karachi. 1x10’s
Minutes for 257th Registration Board Meeting 475
(Evaluator IV: Slateen Waseem Philips)
S/N Name and Brand Name Type of International Deferred in Remarks address of (Proprietary name + Form status in meeting of RB due / manufactur Dosage Form + Initial date, stringent to following Observa er / Strength) diary regulatory shortcomings tions Applicant Composition Fee agencies Pharmacological including Group differential Me-too status Finished product fee Specification Demanded GMP status as Price / Pack depicted in size inspection report (dated)
M/s Novartis Pharma (Pakistan) Limited, 15-West Wharf Road, Karachi, Pakistan referred for minutes of 250th meeting of Registration Board held on 09th – 10th July 2015 for the product Nocid Oral Suspension 10mg/5ml (already deferred in 244th meeting). The said product was not approved by reference drug regulatory agencies. International available formulation is dry powder for suspension in the strength of 40mg/5ml (Ref:US FDA). The decision in the said meeting was as under:- i. Applicants shall revise their formulation as per innovator (new registration application with complete fee) within six months if manufacturing facility is approved by CLB. ii. For already registered drugs, same procedure as mentioned above (at Sr. No. i) shall be adopted. Otherwise show cause notice shall be issued for de-registration of registered drugs in this formulation. iii. All such application shall be processed on priority basis.
Now firm has changed their formulation from 10mg/5ml oral suspension to Nocid (Famotidine) 40mg/5ml suspension according to nationally and international availability of dosage form and applied for registration on prescribed Form 5 along with prescribed fee of Rs. 20,000/- 622. M/s Novartis Nocid 40mg/5ml Form 5 Famotidine Registration Board Shortco Pharma Rs. 20,000/- 40mg/5ml –FDA in its 255th meeting mings (Pakistan) Each 5 ml of vide Dy. No. deferred for rectified Limited, reconstituted 2629 dated Zepsin (Cirin) provision of proof Petaro Road, suspension contains 11-12-2015 of Oral Dry Jomshoro. Famotidine BP 40mg Powder Suspension
Histamine H2 Pack size of (General) Section. receptor antagonist 60ml amber color glass GMP certificate (Manufacture bottle dated 2-3-2016 Specification)
Decision: Registration Board deferred for evaluation as per decision of 250th Registration Board meeting.
Minutes for 257th Registration Board Meeting 476
M/s Ahad Pharmaceuticals Limited, Dera Ismail Khan
623. M/s Ahad Spasmonil Injection Form 5 Deferred as per Pharmaceuticals 17/11/2014 Spasmex decision of 250 Limited, 13km, Each 4ml contains:- Dy. No. 442 (Scharper) meeting of Gomal Phloroglucinol Rs. 20000/- Registration University, Dihydrate As per Board. Multan Road, (USP)…40mg. SRO/4ml Dera Ismail ×6’s The product is still Khan, KPK (Antispasmodic) under expert opinion while firm has requested to re-consider their product for approval as all the shortcomings rectified.
M/s Mafins Pharma, A-5, S.I.T.E, Superhighway Industrial Area, Karachi
Registration Board in its 253rd meeting held on 05-06th October 2015 approved “Derma Cream 1% (Silver Sulphadiazine 1% w/w). In description of the dosage form, a typographical mistake occurred by typing each ointment contains instead of each gram of ointment contains silver sulphadiazine 1% w/v. The firm has requested to make the correction. Accordingly, the case is placed before the Board for correction of the dosage form as under:-
Derma Cream 1% w/w Each gram of ointment conatins Silver Sulphadiazine 10 mg (1% w/w) USP Specification
Decision: Registration Board approved correct formulation.
Minutes for 257th Registration Board Meeting 477
(Evaluator-I: Muhammad Ansar)
Following product of M/s B. Braun were deferred in 254th meeting of the Board and were deferred for the submission of shortcomings mentioned in relevant column. Now the firm has submitted the deficiencies.
624. M/s B. Braun ONDANSETRON B. Form 5A MHRA Deferre Approved Pakistan (Pvt) Braun 2mg/ml approved. d for Limited, The (Solution for Dy. No: Ondansetron clarifica Forum Suite injection/infusion) 446 Accord tion 216, dated 26- Healthcare regardin Khayaban-e- Each ml contains: 12-13 UK. g Jami, Clifton Ondansetron stateme Block -9 Hydrochloride eq. to 100000/- Zofran of nt that Karachi Ondansetron……..2m dated 26- GSK firm g 12-13 Karachi. cannot M/s B. Braun mention Melsungen Antiemetic, anti Rs. 905/- manufac AG, Carl – nauseant, Serotonin Pack of ture Braun-Str.134 5HT3 antagonist 1’s (4ml date on 212 plastic primary Melsungen, BP ampoule) packagi Germany. ng.
Minutes for 257th Registration Board Meeting 478
Complete routine cases: (Evaluator II: Ahsan Ul Haq Athar)
S/N Name and Brand Name Type of Form International Decision address of (Proprietary name + Availability manufacturer / Dosage Form + Initial date, diary Applicant Strength) Me too Fee including differential Composition fee
Pharmacological Group Demanded Price / Pack size Finished product Specification 625 M/s Martin Dow Telara D 80/25mg Form-5 Teltartan Approved Limited, Tablet Dy. No: 308 dated. HCT (Arrow Korangi Each tablet contains: 18.01.2011 Pharma) TGA Industrial Area, Telmisartan USP Rs.8,000/- Karachi-74900 ……… 80mg 31.07.2011 Co-Tasmi (1904) Hydrochlorothiazide Rs.12,000/- (Getz) USP……….25mg Rs. 421.40/10’s Angiotensin II receptors 590/14’s antagonist/ diuretic 1115/28’s (USP specification)
626 M/s Martin Dow Telara D 40/12.5mg Form-5 Teltartan Approved Limited, Tablet Dy. No: 307 dated. HCT (Arrow Korangi Each tablet contains: 18.01.2011 Pharma) TGA Industrial Area, Telmisartan USP Rs.8,000/- Karachi-74900 ……… 40mg 31.07.2011 Co-Tasmi (1905) Hydrochlorothiazide Rs.12,000/- (Getz) USP……….12.5mg Rs. 221.40/10’s Angiotensin II receptors 310/14’s antagonist/ diuretic 620/28’s (USP specification)
627 M/s Genome Solium 400mg Form-5 Amisulpiride Approved Pharmaceuticals, Tablet Dy. No: 2835 dated. (Zentiva) 16/1, Phase IV, Each film coated tablet 19.06.2013 MHRA Industrial estate contains: Rs.20,000/- Phrenic Hattar. Amisulpride ……… As per SRO 400mg (sami) (1384) 400mg 10’s Approved in Antipsychotic 238th meeting (Genome specification)
Minutes for 257th Registration Board Meeting 479
628 -do- Genovel 800mg Form-5 Renvela Deferred for (1383) Tablet Dy. No: 2816 dated. (Sanofi) submission Each film coated tablet 03.06.2013 MHRA of stability data as per contains: Rs.20,000/- st Sevelamer Carbonate As per SRO Renvela 251 meeting …..…… 800mg 30’s (Sanofi) requirement. Polymeric Amine for approved in prevention of 243rd meeting Hypocalcaemia (Genome specification) 629 -do- Paramol plus Form-5 Ultracet Approved (1385) Tablet Dy. No: 2816 dated. (Jassen Each film coated tablet 03.06.2013 Pharma) contains: Rs.20,000/- USFDA Paracetamol…..…… As per SRO 325mg 10’s Tramapar Tramadol HCl (Efroz) p.950 ……37.5mg NSAIDs/ Opioid analgesic (USP specification) 630 -do- Lornom 8mg Form-5 EMA Approved (1382) Tablet Dy. No: 2815 dated. approved Each film coated tablet 03.06.2013 Nycomed contains: Rs.20,000/- 8mg tablet Lornoxicam…..…… As per SRO (Denmark) 8mg 10’s NSAIDs Noxflam (Genome specification) (Genix) 631 -do- Lamot 100mg Form-5 lamictal Approved (1418) Tablet Dy. No: 2823 dated. (GSK) Each film coated tablet 31.05.2013 USFDA contains: Rs.20,000/- Lamotrigine…..…… As per SRO Lojin (Hilton) 100mg 10’s AED of the Phenytriazine class (USP specification)
Minutes for 257th Registration Board Meeting 480
New Licenses/ Additional sections/Remaining applications: (Evaluator I: Muhammad Ansar) M/s Cortex Pharmaceutical, SS4, Rawat: Section R-III vide F.6-4/2013 R-III dated 14-12-2015 has forwarded the applications of M/s Cortex Pharmaceutical, Rawat S/N Name and Brand Name Type of Form International Decision address of (Proprietary Initial date, status in manufacturer / name + Dosage diary stringent Applicant Form + Strength) Fee including regulatory Composition differential fee agencies Pharmacological Demanded Group Price / Pack Me-too status Finished product size Specification GMP status as depicted in inspection report (dated)
632. M/s Cortex Kaolin Poultise Form 5 MHRA. One Approved Pharmaceutical, Minute Poultise SS4, Plot No. Each 100gm 25-11-2015 by M/s KL 16-A, National poultise vide diary No. Pharmaceutical Industrial Zone, contains:- 2293 Rawat. Kaolin…..52.70g Rs.20,000. Local Kayoplast m by M/s Karachi New License As per SRO Chemical Emolient Industries.
B.P Specifications 633. -do- Hydrogen Form 5 MHRA. Approved Peroxide 6% Hydrogen Solution 25-11-2015 Peroxide 6% B.P vide diary No. by M/s Thron & Each 100ml 2296 Ross Ltd contains:- Rs.20,000. Hydrogen Local Hydrogen Peroxide As per SRO Peroxide …..6gm (6%) solution 6% by M/s Pharmawise. Disinfectant
B.P Specifications
Minutes for 257th Registration Board Meeting 481
634. -do- CoreClean Form 5 Dailymed. Approved 4%w/v skin Antiseptic skin cleanser 25-11-2015 cleanser 4% as vide diary No. OTC product Each ml 2295 packed & Hibi contains:- Rs.20,000. Scrub by M/s Chlorhexidine Reagent Gluconate As per SRO …..40mg (4%) Local Chloro-4 by M/s Medipak. Antiseptic Hand wash
B.P Specifications 635. -do- C-Pyidine Scrub Form 5 Dailymed. Scrub Approved Care 7.5 Care Povidone 25-11-2015 Iodine Cleansing Each ml vide diary No. by M/s Leawood contains:- 2294 Povidone Iodine Rs.20,000. Local Povine …..75mg (7.5%) 7.5% By M/s As per SRO Pharmawise. Antiseptic
USP Specifications 636. -do- CoreCare Form 5 MHRA. Salactol Approved Collodion Collodion by 25-11-2015 M/s Derma Each 15ml vide diary No. Laboratories contains:- 2297 Salicylic Rs.20,000. Local Plantar Acid…..…..16.7 By M/s Seatle % As per SRO Pharma. Lactic Acid….16.7%
Keratolytic
Manufacturer’s Specifications
Minutes for 257th Registration Board Meeting 482
M/s. Fynk Phama Lahore (New section)
S/N Name and Brand Name Type of Form Remarks on the Decision address of (Proprietary name + Dosage formulation (if any) manufacturer / Form + Strength) Initial date, diary including Applicant International status Composition Fee including in stringent drug differential fee regulatory agencies / Pharmacological Group authorities Demanded Price / Finished product Pack size Me-too status Specification GMP status as depicted in latest inspection report (with date) by the Evaluator 637. M/s Fynk Cliff Dry Powder Injection Form 5 BNF. Klaricid Approved Pharmaceuticals, IV 500mg Powder for 19-Km G.T, 08-02-2016 vide reconstitution by Road, Kalashah Each vial contains:- diary No. 789 M/s Abbott Kaku, Lahore. Clarithromycin (as R&I Rs.20,000 Lactobionate) eq to Klaricid 500mg by Additional Clarithromycin……500mg As per SRO. M/s Abbott Section Dry Powder Macrolide Injection (General) CLB Manufacturer’s 245th Meeting Specifications 638. -do- Lazol Dry Powder Injection Form 5 FDA. Prevacid IV Approved IV 30mg/vial by M/s 08-02-2016 vide Takeda Each vial contains:- diary No. 785 Lansoperazole……30mg R&I Rs.20,000 Anso injection 30mg by M/s Shaigan Proton pump Inhibitor As per SRO. Pharma.
Manufacturer’s Specifications
Minutes for 257th Registration Board Meeting 483
639. -do- Azure Dry Powder Injection Form 5 MHRA. Zedbac Approved IV powder for Infusion 08-02-2016 vide 500mg/vial by M/s Each vial contains:- diary No. 786 Aspir Pharma Azithromycin (as Dihydrate) R&I Rs.20,000 eq to Zeecin injection Azithromycin……500mg As per SRO. 500mg by M/s Wilshire Pharma. Macrolide
USP Specifications
640. -do- Fismin Dry Powder Injection Form 5 The product was Deferred for approved by the confirmation Each vial contains:- 08-02-2016 vide Board in 254th of approval Fosfomycin (as Sodium) eq diary No. 792 meeting for the status of to Fosfomycin……1g R&I Rs.20,000 change of exporter. same formulation Antibiotic As per SRO. Fosfomycin injection in reference 1gm by M/s Safe regulatory Manufacturer’s Pharma authorities. Specifications
641. -do- E-Prazole Dry Powder Form 5 FDA. Nexium IV Approved Injection IV 40mg/vial by M/s 08-02-2016 vide Astrazeneca Each vial contains:- diary No. 283 Esomeprazole (as Sodium) R&I Rs.20,000 Esso 40mg infusion eq to by M/s Shaigan Esomeprazole……40mg As per SRO. Pharma.
Proton pump Inhibitor
Manufacturer’s Specifications 642. -do- Fymezole Dry Powder Form 5 MHRA. Omeprazole Approved Injection IV 40mg powder for 08-02-2016 vide solution for infusion Each vial contains:- diary No. 798 by M/s Sandoz Omeprazole (as Sodium) eq R&I Rs.20,000 to Omeprazole……40mg Omega 40mg As per SRO. infusion by M/s Proton pump Inhibitor Ferozsons Pharma.
Manufacturer’s Specifications
Minutes for 257th Registration Board Meeting 484
643. -do- Pazole Dry Powder Injection Form 5 FDA. Protonix IV Approved IV 40mg by M/s Wyeth 08-02-2016 vide Pharma Each vial contains:- diary No. 797 Pantoperazole (as Sodium) R&I Rs.20,000 Lesprot 40mg by eq to M/s Nabiqasim Pantoperazole……40mg As per SRO. Pharma.
Proton pump Inhibitor
Manufacturer’s Specifications 644. -do- Ancocin Dry Powder Form 5 MHRA. Approved Injection 1g IV Vancomycin 1g 08-02-2016 vide powder for solution Each vial contains:- diary No. 795 for infusion by M/s Vancomycin (as HCl) eq to R&I Rs.20,000 Wockhardt Vancomycin……1g As per SRO. Hisun 1g, 500mg by Antibiotic M/s Biocare Phar
USP Specifications ma.
645. -do- Ancocin Dry Powder Form 5 MHRA. Approved Injection 500mg IV Vancomycin 500mg 08-02-2016 vide powder for solution Each vial contains:- diary No. 793 for infusion by M/s Vancomycin (as HCl) eq to R&I Rs.20,000 Wockhardt Vancomycin……500mg As per SRO. Hisun 1g, 500mg by Antibiotic M/s Biocare Pharma.
USP Specifications
646. Additional E-Prazole Oral Sachet Form 5 MHRA. Nexium Deferred for Section 10mg gastro clarification Sachet (General) Each Sachet contains:- 09-02-2016 vide resistant granules for of nature of CLB 245th Esomeprazole (as diary No. 821 oral suspension by granules in Meeting Magnesium Trihydrate R&I Rs.20,000 M/s Astrazeneca comparison Enteric coated pellets) eq to to innovator, Esomeprazole……10mg As per SRO. Local. Axesom 10 whether Sachet by M/s effervescent Proton Pump Inhibitor Highnoon. or otherwise. Manufacturer’s Specifications
Minutes for 257th Registration Board Meeting 485
Source Of Pellets:- M/s Vision Pharmaceuticals, Industrial Triangle Kahuta Road, Islamabad.
647. -do- Diral Oral powder Sachet Form 5 The product is Approved approved in 250th Each Sachet contains:- 08-02-2016 vide meeting of RB. Dioctahedral diary No. 791 Smectites……3g R&I Rs.20,000 Smecta by M/s Acto
Antidiarrhoeal/Adsorbant As per SRO.
Manufacturer’s Specifications
648. -do- Verge-H Sachet Form 5 MHRA. Fybogel Approved Sachet Mebeverine Each Sachet contains:- 08-02-2016 vide HCl 135mg & Mebeverine HCl……135mg diary No. 787 Ispagula Husk R&I Rs.20,000 3.5gm. Ispaghula Husk…..3.5g As per SRO. Mebgel sachet by (Granules) M/s Metro
Antispasmodic/adsorbant
Manufacturer’s Specifications 649. -do- Stronium Sachet Form 5 MHRA, UK Approved available in the form Each Sachet contains:- 08-02-2016 vide of granules for oral Strontium Ranelate as oral diary No. 801 suspension granules……2g R&I Rs.20,000 Onita by Pharmevo As per SRO. Karachi. Antiosteoporotic
Manufacturer’s Specifications
Minutes for 257th Registration Board Meeting 486
650. -do- Astel Sachet Form 5 TGA. Singulair Approved Montelukast 4mg (as Each Sachet contains:- 08-02-2016 vide sodium) oral Montelukast as Sodium oral diary No. 788 granules Sachet. granules eq to Montelukast.. R&I Rs.20,000 ……4mg Aerokast 4mg As per SRO. Sachet by M/s Anti Asthmatic Barret
Manufacturer’s Specifications
651. -do- Fismin Oral Sachet Form 5 USFDA. Monurol Approved 3gm base/packet by Each Sachet contains:- 08-02-2016 vide M/s Zambon Fosfomycin Tromethamine diary No. 789 eq to Fosfomycin R&I Rs.20,000 Monurol by granules……3g Scharper As per SRO. Pharmaceutical Pvt Antibiotic Ltd.
Manufacturer’s Specifications
652. -do- Electrobion Oral dry powder Form 5 WHO recommended Approved Sachet formulation 08-02-2016 vide Each Sachet contains:- diary No. 794 OEM Sachet by M/s Sodium Chloride……2.6g R&I Rs.20,000 Indus.
Potassium Chloride……1.5g As per SRO.
Trisodium Citrate Dihydrate…..2.9g
Glucose Anhydrous…..13.5g
Oral Rehydration for Solution
B.P Specifications
Minutes for 257th Registration Board Meeting 487
653. -do- Mocul Oral dry powder Form 5 Movicol Sachet, UK Approved Sachet 08-02-2016 vide Movcol by M/s Each Sachet contains:- diary No. 799 Genix Pharma Sodium R&I Rs.20,000 Chloride……0.3507g As per SRO. Potassium Chloride……0.0466g
Sodium Bicarbonate…..0.1785g
Polyethylene Glycol 3350……..13.125g
Laxative and electrolyte
Manufacturer,s Specifications 654. -do- Orisel Oral dry powder Form 5 MHRA, Dioralyte Approved Sachet Relief sachet by M/s 08-02-2016 vide Sanofi, UK. Each Sachet contains:- diary No. 784 Sodium Chloride……0.35g R&I Rs.20,000 Dioralyte Rice of M/s Sanofi, Karachi. Potassium Chloride……0.3g As per SRO.
Sodium Citrate Citrate…..0.58g
Rice Powder……..6g
Antidiarrhoeals (Rehydration Fluids)
Manufacturer,s Specifications
Minutes for 257th Registration Board Meeting 488
655. -do- Oralyte Oral dry powder Form 5 Approved in 247th Approved Sachet meeting being High 08-02-2016 vide Osmolar formulation Each Sachet contains:- diary No. 783 Sodium Chloride……3.5g R&I Rs.20,000 Peditral ORS Sachet Potassium Chloride……1.5g by M/s Searle. Sodium Citrate As per SRO. Citrate…..2.9g Dextrose Anhydrous……..20g
Oral Rehydration for Solution
Manufacturer,s Specifications
(Evaluator IV: Slateen Waseem Philips)
Case No. 1. M/S WIMITS PHARMACEUTICALS (PRIVATE) LIMITED LAHORE: M/s Wimits Pharmaceuticals (Private) Limited located at Plot # 129, Sundar Industrial Estate (PIE) Raiwind Road Lahore decided to withdraw applications of following three products which were deferred in 243rd meeting of Registration Board:- Brand Name Type of Form International status Decision of 243rd Decision (Proprietary name + Initial date, diary in stringent meeting of RB Dosage Form + Fee including regulatory agencies Strength) differential fee Composition Demanded Price Me-too status Pharmacological Group / Pack size Finished product GMP status as Specification depicted in inspection report (dated)
Femvil Injection Form 5 Avil (Sanofi) Deferred for Rejected Each 2mL contains Normal confirmation of salt Pheniramine Maleate 1355.23-12-2013 form of API 22.7mg equivalent to Rs.20,000/- Firm is new licence 25mg Pheniramine (Original) as per panel salicylate inspection dated As per SRO/ 26.11.2013 Antihistamine. 25 x 2ml
Manufacturer’s Specs
Minutes for 257th Registration Board Meeting 489
Calwim IV Injection Form 5.Normal Calcijex Deferred for PSI by Rejected 488.21-03-2014 Director DTL Lahore Each ml contains 20,000/- Bonky (RG and area FID DRAP Calcitriol …… 1 mcg Pharma) Vitamin D Analogue USP Specs As per SRO/ Firm is new licence 10 x 1ml as per penal inspection dated 26.11.2013
Actopil Syrup 1. Form 5 Referred to review Rejected 2.Normal 1. committee for review of Each 5ml Contains: 3. 648. 09-04- 2.Nootropil (GSK) formulation Piracetam ... 1gm 2014, 3.Firm is new 4.Rs.20,000 licence as per penal Nootropics inspection dated Neuronal metabolic modulator As per SRO/ 26.11.2013 5. Wimits Specs 120 ml
Appetizer Syrup Form 5 Mosegar (Novartis) Rejected being non- Rejected Normal establised / wrong Each 5ml Contains: Dy # 336 dated Firm is new licence indication i.e appetite Pizotifen as Hydrogen 10-01-2014 as per penal stimulent Maleate ……. 0.25mg Rs.20,000/- inspection dated 26.11.2013 Appetite Stimulant As per SRO Manufacturer Specs 120 ml
Now firm has requested to consider following four applications at place of above mentioned applications S/N Name and Brand Name Type of Form International Decision address of (Proprietary Initial date, status in manufacturer / name + Dosage diary stringent Applicant Form + Strength) Fee including regulatory Composition differential fee agencies Pharmacological Demanded Group Price / Pack Me-too status Finished product size Specification GMP status as depicted in inspection report (dated)
Minutes for 257th Registration Board Meeting 490
656. M/S Wimits Dolta Injection Form 5 with fee MHRA approved Approved Pharmaceuticals 100mg/2ml Rs. 20,000/- Zamadol of Meda (Private) vide Dy.# 2740 Pharmaceuticals, Limited Each 2ml ampoule R&I dated 30- UK. Located At Plot contains 12-2014 Tramadol HCl Lamadol – # 129, Sundar USP 100mg Pack size of 5 x Brookes Industrial Estate 2ml / as per (Pie) Raiwind Opiate analgesic SRO GMP compliant Road Lahore Inhouse section vide specification inspection report of grant of DML. 657. -do- Toralac 30mg Form 5 with fee MHRA approved Injection Rs. 20,000/- product of Beacon vide Dy.# 2739 Pharmaceuticals Approved Each ml ampoule R&I dated 30- contains 12-2014 Ketolac-Nimrall Ketorolac Tromethamine Pack size of 5 x GMP compliant USP 30mg 1ml / as per section vide SRO inspection report NSAID of grant of DML. USP specification 658. -do- Famodine Form 5 with fee Deferred. Suspension Rs. 20,000/- The firm shall 10mg/5ml vide Dy.# 333 follow decision R&I dated 10- of 250th meeting Each 5ml ampoule 01-2014 of Registration contains Board. Famotidine BP Pack size of 10mg 60ml Rs. 80/-
H2 antagonist USP specification 659. -do- Ulsicare Form 5 with fee MHRA approved Approved Suspension 60ml Rs. 20,000/- Antepsin, a brand vide Dy.# nil of Chugai, UK Each 5ml ampoule R&I dated 23- contains 12-2013 Ulsanic Sucralfate USP (Highnoon) 1gm Pack size of 60ml Rs. Sucrose sulphate 140/- aluminum complex Firm specification
Minutes for 257th Registration Board Meeting 491
Remaining applications of Additional Section: EVALUATOR IV: Salateen Waseem Philips S/N Name and Brand Name Type of Form International status Remarks / address of (Proprietary name + Initial date, diary in stringent Observatio manufacturer / Dosage Form + Strength) Fee including regulatory agencies ns Applicant Composition differential fee Pharmacological Group Demanded Price Me-too status Finished product / Pack size Specification GMP status as depicted in inspection report (dated)
M/s Ali Noor Industries located at 8-km, Depalpur Road, Okara has been re-granted DML # 000452 by Central Licensing Board on 27-03-2014, for manufacturing in following sections. 1. Cotton Wool 2. Bandage 3. Crepe Bandage 4. Gauze Following dossiers have been received to undersigned from the concerned /dealing section of Registration Division for evaluation as anomaly/remaining cases of above mentioned four sections.
660. M/s Ali Noor Secure Gauze Swabs Form 5 Detax TM x-ray Deferred Industries, 8- Sponge, X-Ray Rs. 20,000/- vide detectable guaze for km, Depalpur detectable BPC Dy. No. 266 dated swabs – comments 25-05-2015 Road, Okara Vernoncarus of
Cleaning wound / Pack size of relevant Available in Topical application 5cm x 5cm registratio 7.5cm x 7.5cm Pakistan by Cotton n section 10cm x 10cm Craft as the as per price fixed case is
by Government anomaly or otherwise, status of GMP. 661. -do- Secure Paraffin Gauze Form 5 Oxymax Paraffin Deferred Sponge B.P Rs. 20,000/- vide Gauze of Adventa for Dy. No. 265 dated Health- UK comments 25-05-2015 of Topical application on wounds Pack size of relevant Paraffin Gauze BP 5cm x 5cm registratio 7.5cm x 7.5cm – Karim Industries n section 10cm x 10cm (8 as the ply) case is as per price fixed anomaly by Government or
Minutes for 257th Registration Board Meeting 492
otherwise, status of GMP.
662. -do- Secure Sponges B.P Form 5 A product of Deferred Abdominal gauze x-ray Rs. 20,000/- vide Sentry Medicals- for detectable BPC Dy. No. 263 dated Australia comments 25-05-2015 of
For blood cleaning and Pack size of relevant Abdominal gauze absorption during 5cm x 5cm registratio abdominal surgery 7.5cm x 7.5cm swabs – Karim n section 10cm x 10cm (8 Industries as the ply) case is
as per price fixed anomaly by Government or otherwise, status of GMP. 663. -do- Secure Gauze Swabs Form 5 Deferred Sponge Sterile BPC Rs. 20,000/- vide Abdominal gauze for Dy. No. 264 dated swabs – Karim comments 25-05-2015 Industries of Cleaning of wounds, body surface or other Pack size of relevant
body cavities 5cm x 5cm registratio 7.5cm x 7.5cm n section 10cm x 10cm (8 as the ply) case is as per price fixed anomaly by Government or otherwise, status of GMP.
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(Evaluator I: Muhammad Ansar) M/s Paramount Pharmaceuticals, Islamabad: Section R-III vide F.6-4/2013 R-III dated 07-03-2016 has forwarded the applications of M/s Paramount Pharmaceuticals, Islamabad (Anomly) with following details “ as in the RB meeting 254, three products of tablet Cephalosporin were deferred and 1 product of dry suspension (General) was rejected. Accordingly following 5 applications 2 of dry suspension section & 3 of tablet Cephalosporin section are submitted " M/s Paramount Furoxi 125mg Tablet Form-5 MHRA. Approved 664. Pharmaceuticals, Zinnat f/c Kahuta Road, Each film coated tablet 04-11-2015 vide tablet 125mg Islamabad. contains:- diary No. 1889 (R&I) by M/s GSK Rs.20,000. Cefuroxime Axetil eq to Local. Zinacef Cefuroxime…….125mg As per SRO tablet 125mg by M/s GSK Cephalosporin. The firm is USP Specifications Overall GMP compliance as per inspection dated 05-01- 2016 by area FID
. 665. -do- Furoxi 250mg Tablet Form-5 MHRA. Approved Zinnat f/c Each film coated tablet 04-11-2015 vide tablet 250mg contains:- diary No. 1892 (R&I) by M/s GSK. Rs.20,000. Cefuroxime Axetil eq to Local. Zinacef Cefuroxime…….250mg As per SRO tablet 250mg by M/s GSK Cephalosporin. The firm is USP Specifications Overall GMP compliance as per inspection dated 05-01- 2016 by area FID
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666. -do- Furoxi 500mg Tablet Form-5 FDA. Ceftin Approved 500mg Each film coated tablet 04-11-2015 vide contains:- diary No. 1890 (R&I) Rs.20,000. Cefuroxime Axetil eq to Cefuroxime…….500mg As per SRO The firm is Overall GMP Cephalosporin. compliance as per inspection USP Specifications dated 05-01- 2016 by area FID
667. -do- Twintic Dry Suspension Form-5 MHRA. Approved Zinnat f/c Each 5ml dry suspension 04-11-2015 vide tablet 250mg contains:- diary No. 1891 (R&I) by M/s GSK. Rs.20,000. Erythromycin Ethylsuccinate……..200mg As per SRO The firm is Sufisoxazole Overall GMP Acetyl…….600mg compliance as per inspection Antibiotic. dated 05-01- 2016 by area USP Specifications FID
668. Xinta Dry Suspension Form-5 Deferred Local Kilin for Each 5ml dry suspension 26-02-2016 vide Syrup by M/s comments/ contains:- diary No. 1232 (R&I) Linear opinion of Rs.20,000. Pharma. WHO Zinc Sulphate Monohydrate The firm is Pakistan eq to elemental As per SRO Overall GMP in Zinc……..20mg compliance as previous per inspection meetings. Mineral. dated 05-01- 2016 by area Manufacturer’s Specifications FID
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(Evaluator I: Muhammad Ansar)
M/s Fynk Pharmaceuticals Lahore: M/s Fynk Pharmaceuticals Lahore has applied for the 10 products for additional section out of which 8 are approved and 2 were deferred. Now the firm has requested that they want to registration of 2 new applications in lieu of deferred applications
M/s Fynk Fengen HC Cream Form 5 Deferred for Rejected Pharmaceutical Gentamicin(as 03.-07- confirmation of s 19-Km G.T sulphate)B.P… 0.3% 2014, vide approval by Road, Hydrocortisone Dy No. regulatory Kalashah AcetateB.P….1.0% 1109 authority of Kaku, Lahore. Corticosteroid & As per reference Cream antibacterial SRO/ countries. /Ointment/Gel Manufacturer’s 10 gm Now Firm has (Steroid) specification requested for approved in withdrawal and 239th meeting applied for fresh of Central application in lieu Licensing of this. Board held on 22-01-2015. -do- Kandax N Cream 15gm Form 5 Rejected Dexamethasone Phosphate 30.-07- Dexa-N Cream , (as Disodium USP) 0.1%, 2014, vide Swiss Pharma Neomycin (as Sulphate Dy No. Deferred for USP) 0.5% 1121 confirmation of (Corticosterides & As per approval by antibacterial) SRO/15 gm regulatory Manufacturer’s authority of specifications reference countries. Now the firm has requested for withdrawal of application and applied a fresh one in lieu of this.
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669. -do- Corteroid Cream Form 5 FDA. Nogenic Approved Each gram contains:- 07-03-2016, HC 1% by M/s Hydrocortisone vide Dy No. Ivax Pharma ……….1% 07 R&I Hydrocortisone Corticosteroid Rs.20,000 Cream 1% by M/s USP Specifications As per Zafa SRO/10gm & 20gm 670. -do- Hydrocin Cream Form 5 FDA. Tri-Luma Approved Each gram contains:- 07-03-2016, by M/s Galderma Fluocinolone Acetonide vide Dy No. Pharma ……….0.01% 06 R&I Hydroquin plus Hydroquinolone………… Rs.20,000 Cream by M/s 4% As per Atco Tretinoin……………...0.0 SRO/ 15gm 5% Corticosteroid Manufacturer’s specifications
Muhammad Amin DDC (PEC-II)
S/N Name and Brand Name Type of Form Remarks on the Decision address of (Proprietary name + formulation (if manufacturer / Dosage Form + Initial date, diary any) including Applicant Strength) International Fee including status in Composition differential fee stringent drug regulatory Pharmacological Group Demanded Price / agencies / Pack size authorities Finished product Specification Me-too status
GMP status as depicted in latest inspection report (with date) by the Evaluator Dry Powder Injection Penicillin (Human)
671. M/s Selmore Selmox Form 5 Amoxicillin Approved Pharmaceuticals Dry Powder Injection Dairy No. 460 Sodium for (Pvt) Ltd. Each vial contains: dated 28-01-2016 Injection by 36Km, Multan Amoxicillin Sodium BP Rs.20,000/- Wockhardt, UK.
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Road Lahore. eq. to As per SRO Amoxil by New License Amoxicillin…..250mg 1’s, 1x10’s GSK, Pakistan (Broad Spectrum Antibiotic (Penicillin Group) (BP specs) 672. M/s Selmore Selmox Form 5 Amoxicillin Approved Pharmaceuticals Dry Powder Injection Dairy No. 470 Sodium for (Pvt) Ltd. Each vial contains: dated 28-01-2016 Injection by 36Km, Multan Amoxicillin Sodium BP Rs.20,000/- Wockhardt, UK. Road Lahore. eq. to As per SRO Amoxil by Amoxicillin…..500mg 1’s, 1x10’s GSK, Pakistan (Broad Spectrum Antibiotic (Penicillin Group) (BP specs) 673. M/s Selmore Selmox Form 5 Amoxcillin Na Approved Pharmaceuticals Dry Powder Injection Dairy No. 452 for injection by (Pvt) Ltd. Each vial contains: dated 28-01-2016 Wockhardt UK. 36Km, Multan Amoxicillin Sodium BP Rs.20,000/- SUPRAMOX Road Lahore. eq. to As per SRO 1gm Injection Amoxicillin……1gm 1’s, Bosch pharma (Broad Spectrum Antibiotic (Penicillin Group) (BP specs) 674. M/s Selmore Mclave 600mg Form 5 Co-amoxiclav Approved Pharmaceuticals Dry Powder Injection Dairy No. 450 for Injection (Pvt) Ltd. Each vial contains: dated 28-01-2016 500/100mg of 36Km, Multan Amoxicillin Sodium BP Rs.20,000/- Wockhardt UK Road Lahore. eq. to As per SRO Ltd Amoxicillin…..500mg 1’s Potassium Clavulanate Calamox of (BP) eq. to Clavulanic Bosch Karachi. acid…100mg (Beta Lactamase Inhibitors / Broad Spectrum Penicillin) (BP specs) 675. M/s Selmore Mclave Injection 1.2gm Form 5 Co-Amoxiclav Approved Pharmaceuticals Dry Powder Injection Dairy No. 471 for injection by (Pvt) Ltd. Each vial contains: dated 28-01-2016 Wockhardt, UK. 36Km, Multan Amoxicillin Sodium BP Rs.20,000/- Augmentin Inj Road Lahore. eq. to As per SRO by GSK, Amoxicillin…..1000mg 1’s Pakistan Potassium Clavulanate (BP) eq. to Clavulanic acid……200mg (Beta Lactamase Inhibitors / Broad
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Spectrum Penicillin) (BP specs)
676. M/s Selmore Tazopin 2.25g Form 5 Tazocin of Approved Pharmaceuticals Dry Powder Injection Dairy No. 477 Pfizer Uk. (Pvt) Ltd. Each vial contains: dated 28-01-2016 36Km, Multan Piperacillin Sodium Rs.20,000/- Tazop of Road Lahore. (USP) eq. to As per SRO Global, Piperacillin ....2.000gm 1’s, Islamabad. Tazobactam Sodium (USP) eq. to Tazobactam…0.250gm Broad Spectrum Penicillin Antibiotic (USP specs) 677. M/s Selmore Tazopin 4.5g Form 5 (Piperacilin / Approved Pharmaceuticals Dry Powder Injection Dairy No. 477 Tazobactam (Pvt) Ltd. Each vial contains: dated 28-01-2016 4g/0.5g Powder 36Km, Multan Piperacillin Sodium Rs.20,000/- for solution for Road Lahore. (USP) eq. to As per SRO infusion by Piperacillin ....4.000gm 1’s, Sandoz Uk.) Tazobactam Sodium (USP) eq. to Tazop of Tazobactam…0.500gm Global, Broad Spectrum Islamabad. Penicillin Antibiotic (USP specs) 678. M/s Selmore Synbox 750mg Form 5 International Deferred for Pharmaceuticals Dry Powder Injection Dairy No. 465 Availability confirmation of (Pvt) Ltd. Each vial contains: dated 28-01-2016 confirmation approval status by 36Km, Multan Amoxicillin Sodium BP Rs.20,000/- required reference Road Lahore. eq. to As per SRO Me-too Status regulatory Amoxicillin…..375mg 1’s, Sulbarax authorities. Sulbactam sodium BP Mediceena eq. to Pharma. Sulbactam……375mg (Manufacturer’s specs) 679. M/s Selmore Synbox 3.0g Form 5 International Deferred for Pharmaceuticals Dry Powder Injection Dairy No. 466 Availability confirmation of (Pvt) Ltd. Each vial contains: dated 28-01-2016 confirmation approval status by 36Km, Multan Amoxicillin Sodium BP Rs.20,000/- required reference Road Lahore. eq. to As per SRO Me-too Status regulatory Amoxicillin…..1500mg 1’s, Sulbarax authorities. Sulbactam sodium BP Mediceena eq. to Pharma. Sulbactam……1500mg (Manufacturer’s specs)
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680. M/s Selmore Carnil 3.2g Form 5 Timentin by Approved Pharmaceuticals Dry Injection Dairy No. 447 GSK UK. (Pvt) Ltd. Each vial contains: dated 28-01-2016 36Km, Multan Ticarcillin disodium Rs.20,000/- TICACLAV 3.2 Road Lahore. (USP) eq.to As per SRO gm Injection Ticarcillin…3000mg 1’s, Clavulanate Potassium (USP) eq.to Clavulanic acid…200mg (Broad Spectrum penicillin antibiotic) (USP specs)
Dry Powder Suspension Penicillin
681. M/s Selmore Lobritin Suspension Form 5 Ampicillin oral Approved Pharmaceuticals Dry Powder oral Dairy No. 469 suspension, (Pvt) Ltd. suspension dated 28-01-2016 Kent Pharma, 36Km, Multan Each 5ml contains: Rs.20,000/- UK Road Lahore. Ampicillin Trihydrate As per SRO Me-too Silpen, BP eq. to Ampicillin 60ml Lowit Pharma. ….250mg (Broad Spectrum Penicillin Antibiotic) (BP specs) 682. M/s Selmore Lobritin Suspension Form 5 Ampicillin oral Approved Pharmaceuticals Dry Powder oral Dairy No. 457 suspension, (Pvt) Ltd. suspension dated 28-01-2016 Kent Pharma, 36Km, Multan Each 5ml contains: Rs.20,000/- UK Road Lahore. Ampicillin Trihydrate As per SRO Me-too BP eq. to Ampicillin 60ml Ampicap ….125mg suspension by (Broad Spectrum Don-Valley, Penicillin Antibiotic) Lahore. (BP specs) 683. M/s Selmore Selmox Suspension Form 5 Amoxicillin oral Approved Pharmaceuticals Dry Powder oral Dairy No. 474 suspension kent (Pvt) Ltd. suspension dated 28-01-2016 pharma UK. 36Km, Multan Each 5ml contains: Rs.20,000/- Amoxil Road Lahore. Amoxicillin Trihydrate As per SRO Suspension BP eq. to 60ml,90ml GSK Pakistan Amoxicillin…..125mg (Broad Spectrum Penicillin Antibiotic) (BP specs)
684. M/s Selmore Selmox Suspension Form 5 Amoxicillin Approved Pharmaceuticals 250mg Dairy No. 454 sugar free oral (Pvt) Ltd. Dry Powder oral dated 28-01-2016 suspension by 36Km, Multan suspension Rs.20,000/- kent pharma,
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Road Lahore. Each 5ml contains: As per SRO UK. Amoxicillin Trihydrate 60ml,90ml Amoxil by BP eq. to GSK, Pakistan Amoxicillin…..250mg (Broad Spectrum Penicillin Antibiotic) (BP specs) 685. M/s Selmore Lobritin Plus Form 5 International Deferred for Pharmaceuticals Suspension Dairy No. 467 Availability confirmation of (Pvt) Ltd. Dry Powder oral dated 28-01-2016 Confirmation approval status by 36Km, Multan suspension Rs.20,000/- required reference Road Lahore. Each 5ml contains: As per SRO regulatory Ampicillin Trihydrate 60ml,90ml authorities. BP eq. to Ampicillin ….125mg Cloxacillin Sodium BP eq. to Cloxacillin …..125mg (Broad Spectrum Penicillin Antibiotic) (Manufacturer’s specs) 686. M/s Selmore Mclav Suspension Form 5 Augmentin Approved Pharmaceuticals 457mg Dairy No. 462 Duo, GSK, UK (Pvt) Ltd. Dry Powder oral dated 28-01-2016 CALAMOX 36Km, Multan suspension Rs.20,000/- SUSPENSION Road Lahore. Each 5ml contains: As per SRO 457mg of Ampicillin Trihydrate 60ml,90ml,100ml Bosch BP eq. to Ampicillin ….400mg Potassium Clavulanate BP eq. to Clavulanic acid..57mg (Broad Spectrum Penicillin Antibiotic) (BP specs) 687. M/s Selmore Mclav Suspension Form 5 Co-Amoxiclav Approved Pharmaceuticals 156.25mg Dairy No. 455 powder for (Pvt) Ltd. Dry Powder oral dated 28-01-2016 suspension by 36Km, Multan suspension Rs.20,000/- Sandoz, UK. Road Lahore. Each 5ml contains: As per SRO Augmentin by Amoxicillin Trihydrate 60ml,90ml,100ml GSK, Pakistan. BP eq. to Amoxicillin…125mg Potassium Clavulanate BP eq. to Clavulanic acid…..31.25mg (Broad Spectrum Penicillin Antibiotic) (BP specs)
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688. M/s Selmore Mclav Suspension Form 5 Co-amoxiclav Approved Pharmaceuticals 312.5mg Dairy No. 446 250/62.5mg/5ml (Pvt) Ltd. Dry Powder oral dated 28-01-2016 Powder for oral 36Km, Multan suspension Rs.20,000/- suspension. Road Lahore. Each 5ml contains: As per SRO Augmentin by Amoxicillin Trihydrate 60ml,90ml,100ml GSK, Pakistan. BP eq. to Amoxicillin….250mg Potassium Clavulanate BP eq. to Clavulanic acid…..62.5mg (Broad Spectrum Penicillin Antibiotic) (BP specs) 689. M/s Selmore Mclav Oral drops Form 5 CO-Amoxiclav Approved Pharmaceuticals Oral Pediatric Drops Dairy No. 461 Sandoz UK. (Pvt) Ltd. Each ml contains: dated 28-01-2016 Augmentin, 36Km, Multan Amoxilillin Tri hydrate Rs.20,000/- GSK Pakistan Road Lahore. BP eq. to As per SRO Amoxicillin…50.00mg 10ml,20ml, Potassium Clavulanate BP eq to Clavulanic acid….12.5mg (Broad Spectrum Penicillin) (BP specs) 690. M/s Selmore Selmox Oral Drops Form 5 Amoxil Approved Pharmaceuticals Oral Pediatric Drops Dairy No. 473 Pediatric (Pvt) Ltd. Each 1.25ml (after dated 28-01-2016 Suspension of 36Km, Multan reconstitution) contains: Rs.20,000/- GSK UK. Road Lahore. Amoxilillin Tri hydrate As per SRO Me-too: Amoxil BP eq. to Amoxicillin 10ml,20ml, drops GSK ..125mg Pakistan. (Broad Spectrum Penicillin) (BP specs)
Capsule Penicillin Section 691. M/s Selmore Lobritin Plus 250mg Form 5 International Deferred for Pharmaceuticals Capsule Dairy No. 463 Availability confirmation of (Pvt) Ltd. Each Capsule contains: dated 28-01-2016 confirmation approval status by 36Km, Multan Ampicillin Trihydrate Rs.20,000/- required reference Road Lahore. BP eq. to Ampicillin As per SRO regulatory ….125mg 100’s, 10x10’s authorities. Cloxacillin sodium BP eq. to cloxacillin……125mg (Broad Spectrum Penicillin) (Manufacturer’s specs )
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692. M/s Selmore Lobritin Plus 500mg Form 5 International Deferred for Pharmaceuticals Capsule Dairy No. 475 Availability confirmation of (Pvt) Ltd. Each Capsule contains: dated 28-01-2016 confirmation approval status by 36Km, Multan Ampicillin Trihydrate Rs.20,000/- required. reference Road Lahore. BP eq. to Ampicillin As per SRO Ampiclox by regulatory ….250mg 1x10’s (10x10’s) GSK, Pakistan. authorities. Cloxacillin sodium BP eq. to cloxacillin……250mg (Broad Spectrum Penicillin) (Manufacturer’s specs ) 693. M/s Selmore Lobritin 250mg Capsule Form 5 Ampicillin Approved Pharmaceuticals Capsule Dairy No. 448 250mg capsule (Pvt) Ltd. Each Capsule contains: dated 28-01-2016 by kent Pharma, 36Km, Multan Ampicillin Trihydrate Rs.20,000/- UK. Road Lahore. BP eq. to Ampicillin As per SRO Ampicillin ….250mg 20’s,100’s capsule by GSK (Broad Spectrum Pakistan Penicillin) (BP specs) 694. M/s Selmore Lobritin 500mg Capsule Form 5 Ampicillin Approved Pharmaceuticals Capsule Dairy No. 453 Trihydrate (Pvt) Ltd. Each Capsule contains: dated 28-01-2016 Capsule of Kent 36Km, Multan Ampicillin Trihydrate Rs.20,000/- Pharma UK Road Lahore. BP eq. to Ampicillin As per SRO ….500mg 20’s,100’s Ampicillin (Broad Spectrum Capsule of GSK Penicillin) Pakistan (BP specs) 695. M/s Selmore Floxin 250mg Form 5 Floxapen Approved Pharmaceuticals Capsule Dairy No. 449 Capsule of (Pvt) Ltd. Each Capsule contains: dated 28-01-2016 Actvis Uk 36Km, Multan Flucloxacillin Sodium Rs.20,000/- Road Lahore. BP eq. to As per SRO Xuniza of Flucloxacillin…250mg 20’s Wilshire Lahore (Penicillinase Resistant Penicillin) (BP specs) 696. M/s Selmore Floxin 500mg Form 5 Floxapen Approved Pharmaceuticals Capsule Dairy No. 456 Capsule of M/s. (Pvt) Ltd. Each Capsule contains: dated 28-01-2016 Actavis UK. 36Km, Multan Flucloxacillin Sodium Rs.20,000/- F-Clox of Delta Road Lahore. BP eq. to As per SRO Pharma. Flucloxacillin…500mg 20’s (Penicillinase Resistant Penicillin) (BP specs)
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697. M/s Selmore Selmox 500mg Form 5 Amoxicillin Approved Pharmaceuticals Capsule Dairy No. 468 Auribindo (Pvt) Ltd. Each Capsule contains: dated 28-01-2016 Pharma, UK 36Km, Multan Amoxicillin Trihydrate Rs.20,000/- Amoxil, GSK Road Lahore. BP eq. to Amoxicillin As per SRO PAkistan …500mg 20’s,100’s (5x20) (Broad Spectrum Penicillin Antibiotic) (BP specs) 698. M/s Selmore Selmox 250mg Form 5 Amoxicillin Approved Pharmaceuticals Capsule Dairy No. 451 250mg capsule (Pvt) Ltd. Each Capsule contains: dated 28-01-2016 Accord health 36Km, Multan Amoxicillin Trihydrate Rs.20,000/- care UK. Road Lahore. BP eq. to Amoxicillin As per SRO Amoxil GSK …250mg 20’s,100’s (5x20) Pakistan. (Broad Spectrum Penicillin Antibiotic) (BP specs) 699. M/s Selmore Amlox 500mg Capsule Form 5 International Deferred for Pharmaceuticals Capsule Dairy No. 459 availability confirmation of (Pvt) Ltd. Each Capsule contains: dated 28-01-2016 confirmation approval status by 36Km, Multan Amoxicillin Trihydrate Rs.20,000/- required. reference Road Lahore. BP eq. to Amoxicillin As per SRO regulatory …250mg 20’s,100’s (5x20) Flucomox by authorities. Flucloxcillin Sodium Lemachemi (BP) eq. to Flucloxacillin…250mg (Broad Spectrum Penicillin / Penicillinase Resistant Penicillin) (Manufacturer’s specs) M/s Gallop Pharma Lahore-Remaining applications (Anomly cases) Registration Board in 254th meeting has considered 08 registration applications of M/s Gallop Pharma, Lahore in SVP section and 06 in ampoule section. The firm has applied for remaining applications as follows:
700. M/s Gallop G-SOL 5% (100ml) Form-5 Dextrose 5% by Approved Water Science IV Infusion Dy. No: 659 Baxter 404, Sundar Each 100ml contains dated. Healthcare UK. Industrial Estate Dextrose Anhydrous 01-02-2016 Lahore ….5gm Rs.20,000/- B-Braun G5 by SVP section (Caloric solution) Rs.49/- M/s B-Braun B.P Specs 100ml New Section 701. M/s Gallop G-Sol (NS) 100ml Form-5 Sodium Approved Water Science IV Infusion Dy. No: 660 Chloride 0.9% 404, Sundar Each 100ml contains. dated. by Baxter Industrial Estate Sodium Chloride…. 01-02-2016 Health care UK Lahore 0.9g Rs.20,000/- Me too SVP section (Electrolyte) Rs.49/- Plasaline 0.9% 100ml by Otsuka
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702. M/s Gallop G-H2O (10ml) Form-5 Water for Approved Water Science Injection Dy. No: 664 injection by 404, Sundar Water for injection dated. Otuska Japan Industrial Estate (Sterile Irrigating 01-02-2016 Water for Lahore Solution) Rs.20,000/- injection B- Ampoule B.P Specs Rs.900/- Braun section 100x10ml 703. M/s Gallop G-H2O (20ml) Form-5 Water for Approved Water Science Injection Dy. No: 661 injection by 404, Sundar Water for injection dated. Otuska Japan Industrial Estate (Sterile Irrigating 01-02-2016 Water for Lahore Solution) Rs.20,000/- injection B- Ampoule B.P Specs Rs.1300/- Braun section 100x20ml 704. M/s Gallop G-Ligno Form-5 Lidocaine By Approved Water Science Injection Dy. No: 658 M/s Hospira 404, Sundar Each 10ml contains dated. USA Industrial Estate Lignocaine 01-02-2016 Xylocaine 2% Lahore HCl....200mg Rs.20,000/- By M/s Barrett Ampoule (Local Anaesthetics Rs.18/- Hodgson section and antiarrhythmic) 10ml
705. M/s Gallop G-SOL (NS) 25ml Form-5 Sodium Approved Water Science IV Infusion Dy. No: 662 Chloride 0.9% 404, Sundar Each ml contains dated. By M/s Industrial Estate Sodium Chloride… 01-02-2016 Eurohlth Intl Lahore 0.009gm Rs.20,000/- (FDA approved) Ampoule (Electrolyte) Rs.1300/- Plasaline 0.9% section 100x25ml by M/s Otsuka
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Dr Hafsa Karam Ellahi, DDC (PEC-I)
Remaining applications of New License
S/N Name and Brand Name Type of Form Remarks on the Decision address of (Proprietary name Initial date, formulation (if manufacturer / + Dosage Form + diary any) including Applicant Strength) Fee including International Composition differential fee status in Pharmacological Demanded stringent drug Group Price / Pack regulatory Finished product size agencies / Specification authorities Me-too status GMP status as depicted in latest inspection report (with date) by the Evaluator
706. M/s Mission Fomag Bing Tablet Form 5 Magnebind 400 Deferred for the Pharmaceutical Tablet Dairy No. 378 RX by confirmation approval Plot No. A/94 Each film coated dated 07-09- Nephro-Tech status in Pakistan. S.I.T.E Super tablet contains: 2015 INC-USA Highway, Magnesium Rs:2,0000/- Karachi. carbonate….400mg 100’s bottle / Calcium Rs.1000/- carbonate….200mg Folic acid ……1mg (Mineral, vitamin supplement)
707. M/s Mission Neo Enema Form 5 Fphopho-soda Deferred for the Pharmaceutical Solution Dairy No. 379 USA clarification of Plot No. A/94 Solution dated 07-09- manufacturing S.I.T.E Super Each 10 ml 2015 Kleen enema by facility/section from Highway, contains: Rs:2,0000/- M/s Nabiqasim CLB. Karachi. Sodium 120ml / Rs.45/- phosphate….0.6gm Sodium biphosphate…1.6g m USP (Faecal softener, laxative)
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Item No.VI: Cases referred by Biological Drugs Division.
Case No.01 Registration of Import Product Namely Medirin Heparin Sodium 5000IU/ml & 25000IU/ml M/s Medi Mark Pharmaceutical Lahore and Hepacin Injection 25000 iu/5ml, Bajwal Sons, Lahore
M/s Medi Mark Lahore had applied for registration of Medirin Injection (Heparin) 25000 IU/5ML and Medirin Injection (Heparin) 5000IU/ml and M/s Bajwasons, Lahore had applied for registration of Hepacin Injection 25000 iu/5ml. Both companies have same manufacturer abroad. The case is being placed 254th meeting before the Registration Board. The decision of 254th Registration Board meeting as follows:
“Registration Board deferred the case. M/s Medi Mark and Bajwa sons has same source. Firm will be advised to provide latest Whole Sale Agency Certificate from manufacturer. Complete information for CoPP is also required”.
Later on the M/s Medi Mark has provided copy of sole agency agreement with its Chinese manufacturer. The document is not on the company letter head nor has been notarized. The Medi Mark provided also copy of CoPP. The case was placed on agenda of 256th meeting of Registration Board. Documentary details as below:
The case is being placed before the Board on the written direction of Director (Biological Division).
S.No Company Name of Name of Product Date of Remarks Name Manufacturer / Composition application / Fee status
1. Medi Mark Furen MEDIRIN Date of Mee too Pharma, Pharmaceutical INJECTION Application Lahore. Group Co., Ltd, 5000IU/ML 23-05-2013 Address: 1 Xuan Wu Composition Fee deposited Economic Rs.100000/- Developing - (Heparin Sodium area, Luyi Injection 5000 Balance fee Country, Henan IU/ml ) Nil
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China. Address 2: Anti Coagulant No.1 Tongyuan road, Industrial centralized area, LuYi County, Henan Province China
2. Medi Mark Furen MEDIRIN Date of Mee too Pharma, Pharmaceutical INJECTION Application Lahore. Group Co., Ltd, 25000 IU/5ML 23-05-2013 Address: 1 Xuan Wu Composition Fee deposited Economic (Heparin Sodium Rs.100000/- Developing - 25000IU/5ml) area, Luyi Balance fee Country, Henan Anti Coagulant Nil China. Address 2: No.1 Tongyuan road, Industrial centralized area, LuYi County, Henan Province China
3. Bajwa Sons, Furen Hepacin Injection Date of Mee Too Lahore. Pharmaceutical 25000 iu/5ml Application Group Co. Ltd., Each 5ml contains:- 07.05.2012 Xuan Wu Heparin Sodium Economic eq to Fee deposited Developing - Heparin...25000 i.u 15000+ area, Luyi (Anticoagulant). 35000+ Country, Henan 50000 China. . Balance fee Nil
Registration Board decided as follows:
“Registration board considered above applications of Medi Mark Pharma, Lahore and advised to provide legalized CoPPs and notarized sole agency agreement.”
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M/s Medi Mark has now provided the legalized CoPP (original) and notarized sole agency agreement as per directions of the Registration Board. However till date M/s Bajwa sons has not submitted any of the documents as directed in 254th meeting mentioned above.
Decision: Registration Board considered the request of M/s Medi Mark Lahore and referred the applications for expert opinion of as per uniform practice of Regisatration Board by the following: i. Brig. (R) Muzamil Hussain Najmi, Member Registration Board. ii. Brig. Abid Azhar, AFIP, Rawalpindi. iii. Dr. Masud-ur-Rehman, DDG DRAP, Lahore.
M/s Medi Mark is advised to provide the notarized sole agency agreement from country of origin. As two manufacturing sites have been mentioned on CoPP submitted by M/s Medi Mark Lahore, therefore clarification will be obtained from firm about manufacturing site. The application of M/s Bajwa Sons Lahore will be considered after aforementioned clarification.
Case No.02: Registration of Import Product Namely Poulvac SE M/s Hi-Tech Lahore It is submitted that following product of M/s Hi-Tech Pharma Lahore was considered in the 252nd meeting of Registration Board, wherein the Board, while keeping in view the expert opinion of Prof. Dr. Masood Rabbani, Chairman Department of Microbiology, UVAS Lahore and Prof. Dr. Khushi Muhammad, Dean FVS UVAS Lahore approved the product.
Applicant Name and Specs M/s Hi-Tech Poulvac ® SE Vaccine Pharmaceutica l, Lahore Each 0.3ml dose containing Manufactured by: M/s Pfizer Salmonella enteritidis Phase Type Animal Health (Pfizer Inc), 4….RP…> 1.0/dose at release. 2000 Rockford Road, Salmoella enteritidis Phase Type Charles City, Iova, 8…RP….>1.0/dose at release. USA Salmonella enteritidis Phase Type 13a…RP…> 1.0/dose at release 37% Formaldehyde. Solution.0.0006ml, White oil…0.1995ml Arlacel- 83…0.1105 ml Tween- 80…0.001105ml and Saline…q.s to 0.3ml
“Registration Board approved finished import of Poulvac ® SE Vaccine Each 0.3ml dose
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contains: - Salmonella enteritidis Phase Type 4….RP…> 1.0/dose at release. Salmoella enteritidis Phase Type 8…RP….>1.0/dose at release. Salmonella enteritidis Phase Type 13a…RP…> 1.0/dose at release 37% Formaldehyde. Solution 0.0006ml. White oil …0.1995ml Arlacel-83…0.1105ml Tween-80…0.001105ml and Saline… q.s. to 0.3ml), from Zoitis Inc. Lawa, USA, as per USDA approval and in accordance with the import policy for finished drugs:. It is further submitted that product was again included inadvertently in the 253rd meeting of Registration Board wherein the Board decided as follow:-
“Registration Board deliberated and deferred the case for technical opinion of Dr. Muhammad Arshad (Member Registration Board – Veterinary Expert) as he was not present in the meeting.”
Decision: Registration Board approved Poulvac ® SE Vaccine for registration.
Case No.03: Registration of Import Human Biologicals Drugs from (Non Reference Agencies) M/s Scilife Pharma (Pvt) Ltd. Karachi.
The case is placed before 254th Registration Board Meeting. Registration Board deferred the cases for completion of applications, remaining fee, CoPP status, information regarding availability in country of origin and deliberations regarding requirement for bio-similarity of products.
The firm is submitted documents as directed in 254th meeting mentioned above.
Sr.No Name of Brand Name / Date of Documentary Remarks . Importer / Composition application / details Manufacturer Fee status / Packing / MRP 27. SciLife Pharma Bival Dy.No. 1527 Legalized (Pvt) Ltd. (Biavalirudin) (R&I) DRAP COPP No. Karachi, Pakistan Lyophilized dated 28-2-2013 20150032 Powder for dated 27-5- Manufacturer: Injection or Fee Rs. 2015 infusion 250 mg 100000/- dated Shenzhen 25-2-2013 Product Salubris Each vial contains: Unit pack size: License No. Pharmaceuticals 1Vial H20110095 Co., Ltd. No. 1 Bivalirudin….250 dated 15-8-
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the fifth Planning mg Price Rs. 2011. road, Industrial 18200/- zone, Pingshan Pharmacological New District group: Drugs available Shenzhen, Anti-thrombotic in the country Guangdong, Agent of origin China.. Indication: For use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA). 28. SciLife Pharma Enoxa Dy No. 359 Dir Legalized Me Too (Pvt) Ltd. Solution for (Bio) dated 08- COPP No. Karachi, Pakistan injection 6-2013 20150348 (Enoxaparin Dated 03-6- Manufacturer: sodium ) Fee Rs. 50000/- 2015. enclosed. dated 27-6-2013 Hebi Changshan Each pre-filled + 50000/- dated Product Biochemical syringe contains: 09-11-2015 License No. Pharmaceutical 80mg/0.8ml GUOYAOZH Co., Ltd. No.9 Enoxaparin sodium Unit pack size: 2 UNZIH200639 Fuqiang Road, USP…80mg Pre-Filled 10 dated Zhengding, (equivalent to Syringes Shijiazhuang, 8,000 IU anti-Xa Legalized GMP China. activity in 0.8ml) Price Rs. 487/- Certificate No. per Pre-filled CN20130314 Pharmacological Syringe. dated 15-10- group: 2013 Valid until 14-10- Anti-thrombotic 2018 enclosed Agent 29. SciLife Pharma Enoxa [Specs: Dy No. 357 Dir Legalized GMP Me Too (Pvt) Ltd. USP] (Bio) dated 28- Certificate No. Karachi, Pakistan (Enoxaparin 6-2013 CN20130314 sodium) Injection dated 15-10- Manufacturer: 40mg/0.4 ml in Fee Rs. 50000/- 2013 enclosed PFS dated 27-6-2013 Valid until 14- Hebi Changshan Solution for + 10-2018. Biochemical injection. 50000/- dated Pharmaceutical 09-11-2015 Legalized Co., Ltd. No.9 Each pre-filled COPP No. Fuqiang Road, syringe contains: 20150346 Zhengding, Enoxaparin Sodium Unit pack size: 2 dated 03-06-
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Shijiazhuang, USP….40mg Pre-Filled 2015 enclosed China. (equivalent to syringes 4,000 IU anti-Xa Price Rs. 625/- Product activity in 0.4ml). Rs.312.50/- per License No. Pre-Filled GUOYAOZH Pharmacolgical Syringe UNZI group: H20063913
Anti-thrombotic Copy of Power Agent of Attorney enclosed 30. SciLife Pharma Enoxa [Product Dy No. 360 Dir Legalized Me Too (Pvt) Ltd. Specs: USP] (Bio) dated 28- COPP No. Karachi, Pakistan (Enoxaparin 6-2013 20150347 Sodium) Injection dated 03-6- Manufacturer: 60mg/0.6 in PFS Fee Rs. 50000/- 2015 valid until 27-6-2013 30-4-2017 Hebi Changshan Each pre-filled +50000/- dated enclosed Biochemical syringe contains: 09-11-2015 Product Pharmaceutical Enoxaparin sodium License No. Co., Ltd. No.9 USP…..60mg Unit pack size: 2 GUOYAOZH Fuqiang Road, (equivalent to Pre-Filled UNZI Zhengding, 6,000 IU anti-Xa Syringes H20063919 Shijiazhuang, activity in 0.6ml) Copy of GMP China. Price: Rs. 802/- Certificate NO. Pharmacological Rs.401/- per CN20130314 group: Pre-Filled dated 15-10- Anti-thrombotic Syringe 2013 valid until Agent 14-10- 2018.enclosed 31. SciLife Pharma Enoxa Dy No. 358 Dir Legalized Me Too (Pvt) Ltd. [Product Specs: (Bio) dated 18- COPP NO. Karachi, Pakistan USP] 6-2013 20150345 Enoxaparin Sodium dated 03-6- Manufacturer: Solution for Fee Rs. 50000/- 2015 enclosed Injection dated 27-6-2013 Hebi Changshan 20mg/0.2ml in PFS + 50000/- dated Product Biochemical 09-11-2015 License No. Pharmaceutical Each pre-filled GUOYAOZH Co., Ltd. No.9 syringe contains: Unit pack size: UNZI Fuqiang Road, Enoxaparin sodium 2-Prefilled H20063911 Zhengding, USP….20mg syringes Shijiazhuang, (equivalent to Copy of GMP China. 2,000 IU anti-Xa Price: 356/- Certificate No. acitivity in 0.2ml) Rs. 178/- per CN20130314 Pre-Filled dated 15-10- Pharmacolgical Syringe. 2013 valid until group: 14-10-2018 Anti-thrombotic enclosed Agent
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Decision: Registration Board deferred the case for expert opinion of Maj. Gen. Muhammad Ayub, Comdt, AFIP, RWP and Maj. Gen. Muhammad Aslam, Member Registration Board.
Case No.4. Registration of Diptheria & Tetanus vaccine Adsorbed for Adults and Adolescents 1 dose/0.5ml Vial (WHO Prequalified) M/s Sind Medical Store, Karachi
It is submitted that following products of M/s Sind Medical Store Karachi are approved in the 240th meeting of Registration board held on 07-11-2013. a. Diptheria & Tetanus vaccine Adsorbed for Adults and Adolescents 1 dose/0.5ml Vial
The case was sent to the Pricing division for price confirmation, and they informed that prices of above mentioned drugs are approved in the 12th DPC. Detail is tabulated below:
Sr.No Composition / Molecule Approved price in 12th DPC 1. Diptheria & Tetanus vaccine Rs. 85.00/ Adsorbed for Adults and 1x0.5ml Vial Adolescents 1 dose/0.5ml Vial
It is pertinent to mention that 0.5ml single dose ampoule of above vaccine has been applied by the, however in the agenda of 240th meeting it is inadvertently written as vial subsequently the same has been reflected in the minutes of meeting. Later on price of the 0.5ml single dose vial has been fixed instead of ampoule in the 12th DPC. The correction in the minutes of 240th meeting is required so that case may also be again sent to pricing for comments as the price is fixed for single dose vial however in instant case applied product is single dose ampoule. Decision: Registration Board approved Diphtheria & Tetanus vaccine Adsorbed for Adults and Adolescents 1 dose/0.5ml ampoule as per valid legalized CoPP and WHO prequalification approval. Reference will be sent to Cost and Pricing division for fixation of MRP of ampoule, as earlier price has been fixed for vial. Registration Board deferred rest of agenda due to paucity of time. Meeting ended with a vote of thanks to and from the chair. End of Document *************************************************************************
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