Government of Pakistan s8

DIVISION OF DRUG LICENSING

MONTHLY PROGRESS REPORT TO BE UPLOADED ON OFFICIAL WEBSITE OF DRAP FOR THE PERIOD FROM 01-02-2015 to 28-02-2015

NO. OF CASES / S. TYPE OF ASSIGNMENT WORK NO. DISPOSED OFF Verification of Site for Establishment of Pharmaceutical Units 04 1. Approval of Site for Establishment of Pharmaceutical Units 04 2. Approval of Building Layout Plans / Expansion 3. 25 Direction Issued for Panel Inspections for Grant of Additional 4. Sections 07

Grant/approval of Additional Sections by CLB/ conveyed thereof 5. 07

Approval of Technical Staff under rule 15&16 of Drugs (Licensing, 6. Registering & Advertising) Rules, 1976 06

Direction Issued for Panel Inspection for Grant Of New Drug 7. Manufacturing LICENSES 06

New Drug Manufacturing Licenses / issued / conveyed by CLB/ 8. conveyed thereof 00

Direction issued for Panel Inspection (s) of Pharmaceutical Units for 9. Renewal of Drug Manufacturing Licenses 05

Renewal of DML (issuance of Renewal of Drug Manufacturing 10. 00 Licenses) Inspection Books issued 11. 03 Change of company names/ title / management of firm under Rule 12. 5(6) of Drugs (Licensing, Registering & Advertising) Rules, 1976 02

Miscellaneous (deficiencies / shortcomings with respect to lop, Technical Staff, completion of applications for Grant / Renewal of 13. 37 DML, Site Approval / Verification documents etc) S. N TYPE OF CASES / WORK DISPOSED OFF & NAMES OF FIRMS O 1. VERIFICATION OF SITE FOR ESTABLISHMENT OF PHARMACEUTICAL UNITS (04) 1. M/s Medipak Ltd, 554, Sunder Industrial Estate, Lahore. 2. M/s Falak Pharma Industry, GT Road, Sadhoki Station 42-KM, Lahore. 3. M/s KBR Pharmaceuticals, Plot No.123-B, Phase-V, Industrial Estate, Hattar. 4. M/s Medi Land Pharma Plot No.E-1, E-Block, SGM Memon Goth Industrial Estate, Phase-II, Murad Memon Goth, Malir, Karachi. 2. APPROVAL OF SITE FOR ESTABLISHMENT OF PHARMACEUTICAL UNITS (04) 1. M/s Salute Pharma ceuticals, Plot No.E/61-A, Super Highway Phase-II, Karachi. 2. M/s Maverick Pharmaceuticls, 9-KM, Bosan Road Near Coslab, Multan. 3. M/s Shafi Pharmaceuticals, plot No.-A, Usman Block Al-Badar Industrial Zone, Phase-II, Bhatia Wala Road, Lahore. 4. M/s Umbiqa Pharmaceutical, Chakbeli Road, Pindori Stop, Chakbeli Khan, Rawalpindi. 3. APPROVAL OF BUILDING LAYOUT PLANS / EXPANSION (25)

1. M/s Avanza Healthcare (Pvt) Ltd, Sunder Industrial Estate, Lahore. 2. M/s Pharmatec Pakistan (Pvt) Ltd, Karachi. 3. M/s Pfizer Pakistan Ltd, Karachi. 4. M/s Wnsfield Pharmaceuticals, Hattar. 5. M/s Global Pharmaceuticals (Pvt) Ltd, Islamabad. 6. M/s AJM Pharma (Pvt) Ltd, Karachi. 7. M/s Palpex Pharma (Pvt) Ltd, Karachi. 8. M/s Bosch Pharmaceuticals (Pvt) Ltd,, Karachi. 9. M/s Hansel Pharmaceuticals (Pvt) Ltd, Lahore. 10. M/s AGP (Pvt) Ltd, Karachi. 11. M/s Novex Pharma Rawalpindi. 12. M/s Faas Pharmaceuticals (Pvt) Ltd, Karachi. 13. M/s Bosch Pharmaceuticals (Pvt) Ltd,, Karachi. 14. M/s Vetz Pharmaceuticals, Karachi. 15. M/s Reko Pharmacal (Pvt) Ltd, Lahore. 16. M/s Max Pharmaceuticals, Rawat. 17. M/s English Pharmaceutical Industries, Lahore. 18. M/s Spancer & Company (Pvt) Ltd, Karachi. 19. M/s Pharmasol (Pvt) Ltd, Lahore. 20. M/s Saffron Pharmaceuticals (Pvt) Ltd, Lahore. 21. M/s Stallion Pharmaceuticals (Pvt) Ltd, Lahore. 22. M/s Adamjee Pharmaceuticals, Karachi. 23. M/s Medlinx Pharmaceutical, Rawat, Rawalpindi. 24. M/s Abbott Laboratories Pakistan Limited, Karachi DML No.000001 (Formulation) 25. M/s Medipak Ltd Lahore. 4. DIRECTION ISSUED FOR PANEL INSPECTIONS FOR GRANT OF ADDITIONAL (07)

1. M/s Pharmagen Limited, Lahore. 2. Area FID, DRAP, Islamabad, M/s Vision Pharmaceutical Islamabad. 3. M/s Pharmigea Pakistan (Pvt) Ltd, Lahore. 4. M/s Bio Labs (Pvt) Ltd, Islamabad. 5. M/s Saffron Pharmaceuticals (Pvt) Ltd, Lahore. 6. M/s Ipram International Rawat. 7. M/s Ferozsons Laboratories Ltd, Peshawar. 5. GRANT/APPROVAL OF ADDITIONAL SECTIONS BY CLB/ CONVEYED THEREOF (07)

1. M/s Envoy Pharmaceuticals (Pvt) Ltd., 27-Km, Multan Road, Maraka Lahore 2. M/s Ipram International Rawat. 3. M/s Wellborne Pharmachem and Biologicals, Plot No.51/1 – 52/1, Phase-II, Industrial Estate, Hattar. 4. M/s International Pharma Labs, Raiwind Road, Bobhtain chowk Defence Road, 1-km, Toward Khana Lahore. 5. M/s Fynk Pharmaceuticals, 19-Km, Ferozepur Road, G.T. Road, Kala shah Kaku, Lahore. 6. M/s Aventek Pharmaceuticals, Plot No. 44-c, Sunder Industrial Estate, Lahore. 7. M/s Sayyed Pharmaceuticals (Pvt) Ltd., Plot No. 67/2, Phase 3, Industrial Estate, Hattar. 6. APPROVAL OF TECHNICAL STAFF UNDER RULE 15&16 OF DRUGS (LICENSING, REGISTERING & ADVERTISING) RULES, 1976 (06)

1. M/s Farmigea Pakistan (Pvt). Ltd, 4.5, Km., Raiwind Manga Road, Raiwind, Lahore. 2. M/s Festal Labs. Link katar Ban Road, Thokar Niaz Baig, Lahore. 3. M/s sanofi-aventis Pakistan limited, G.T Road, Wah Cantt. 4. M/s McOlson Research Laboratories (Pvt) Ltd., 26-Km, Lahore Sharikpur Road Dhamkey, District Sheikhupura. 5. M/s Arsons Pharmaceutical Industries (Pvt) Ltd, Lahore. 6. M/s Harison Pharmaceutical, 10-Km Lahore Road, Sargodha. 7. DIRECTION ISSUED FOR PANEL INSPECTION FOR GRANT OF NEW DRUG MANUFACTURING LICENSES (06)

1. M/s Ras Pharmaceutical, Lahore. 2. M/s Ciba Pharmaceuticals (Pvt) Ltd.,A-371, S.I.T.E. Nooriabad, Main Super Highway,Karachi 3. M/s Alza Pharmaceuticals, Rawalpindi. 4. M/s Gallop Water Sciences, Lahore. 5. M/s PCP Labortories, Okara. 6. M/s Ice Berg Pharmaceuticals (Pvt) Ltd, Nowshera. 8. NEW DRUG MANUFACTURING LICENSES / ISSUED / CONVEYED BY CLB/ CONVEYED THEREOF (00) 9. DIRECTION ISSUED FOR PANEL INSPECTION (S) OF PHARMACEUTICAL UNITS FOR RENEWAL OF DRUG MANUFACTURING LICENSES (05)

1. M/s Medipak Ltd Lahore. 2. M/s Ottoman Pharma, 10-Km, Raiwind Roadk Lahore. 3. M/s Otsuka Pakistan Ltd, Plot No.4-9 Hub Industrial Trading Estate, Balochistan. 4. M/s Festal Labs. Link katar Ban Road, Thokar Niaz Baig, Lahore. 5. M/s Max Pharmaceuticals, Plot No. 12, Street No. 7-N, National Industrial Zone, Rawat. 10 RENEWAL OF DML (ISSUANCE OF RENEWAL OF DRUG MANUFACTURING . LICENSES) (00) 11 INSPECTION BOOKS ISSUED (03) . 1. M/s Saakh Pharma (Pvt) Ltd, Karachi. 2. M/s Venus Pharma, Lahore. 3. PDH, Pharmaceuticals (Pvt) Ltd, Lahore.

12 CHANGE OF COMPANY NAMES/ TITLE / MANAGEMENT UNDER RULE 5(6) OF . DRUGS (LICENSING, REGISTERING & ADVERTISING) RULES, 1976 (02).

1. M/s Gallop pharmaceutical, Lahore 2. M/s Avanza Healthcare (Pvt) Ltd Lahore 13 MISCELLANEOUS (DEFICIENCIES / SHORTCOMINGS WITH RESPECT TO LOP, . TECHNICAL STAFF, COMPLETION OF APPLICATIONS FOR GRANT / RENEWAL OF DML, SITE APPROVAL / VERIFICATION DOCUMENTS ETC) (37)

1. M/s Noble Pharma, Plot No.B-1, Old Industrial Area, Mirpur Azad Kashmir. 2. M/s Dr.Sethi Industries, 3-Bure Wala Road, Chichawatni. 3. M/s Rotexmedica Pakistan (Pvt) Ltd., Plot No.206-207, Industrial Triangle, Khuta Road, Islamabad. 4. Director Budget & Accounts DRAP, Islamabad. 5. M/s Wellborne Pharmachem and Biologicals, Plot No.51/1 – 52/1, Phase-II, Industrial Estate, Hattar. 6. DDC (LA) DRAP, Islamabad. 7. AD (Accounts) DRAP, Islamabad. 8. Director (MIS) DRAP, Islamabad. 9. Mr. Ajmal Sohail Asif, FID, DRAP, Lahore. 10. M/s Alen Pharmaceuticals (Pvt) Ltd,138-A, Road No.1, Indus Estate, Risalpur. 11. AD (Admin-I) DRAP, Islamabad. 12. Director (MIS) DRAP, Islamabad. 13. M/s Quaper (Pvt) Ltd., 26-A, S.I.E. Lahore Road, Sargodha 14. M/s English Pharm, Indus Link Katarband Road, Thokar Niaz Beg, Lahore. 15. M/s Life Pharma Co., 24-III Industrial Estate, Multan. 16. Director (MIS) DRAP, Islamabad. 17. Syed Jawed Yousuf Bukhari, Karachi. 18. Syed Muied Ahmad, Karachi. 19. Syed Jamshed Ali Kazmi. Karachi 20. Dr. Ikram Ul Haq, Lahore 21. DDC (LA) DRAP, Islamabad. 22. ADC (AB) DRAP, Islamabad. 23. M/s Zafa Pharmaceuticals, L-4/1, Blolck 21, Federal B Area Karachi. 24. Director (QA/LT) DRAP, Islamabad 25. M/s Unison Chemical Works, Lahore. 26. M/s Winn Bexy Pakistan Pharmaceuticals, Plot No. 29-A Punjab Small Industrial Estate, Bahtar More, Rawalpindi 27. M/s Nawabsons laboratories (Pvt) Ltd, Jia Bagga off Raiwind Road, Lahore 28. M/s Shazal’s Pharmaceuticals, Plot No.41/1-A, Phase-I, Industrial Estate, Hattar. 29. M/s 3N Lifemed Pharmaceuticals, Sargodha. 30. M/s Linz Pharmaceuticals (Pvt) Ltd, Karachi. 31. M/s Medwell Pharmaceuticals, Tarella Road, Lawrencepur Faqirabad. 32. M/s Syed Jawed Yousaf Bukhari, Karachi. 33. Syed Muied Ahmad, Karachi. 34. Deputy Registrar, National Industrial Relations Commission Islamabad, Lahore. 35. M/s Jawa Pharmaceuticals (Pvt) Ltd, Lahore. 36. M/s Everest Pharmaceuticals, Islamabad. 37. M/s Scotmann Pharmaceuticals, Islamabad.