LETTERS FOR ISSUE ON 20.03.2014
REGISTRATION
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER/ Takeda Pharmaceuticals India Pvt. Ltd. / 4312 / AMENDMENT LETTER
/ ARCHERCHEM / 57854 / APPROVAL LETTER
VACCINE DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS
1 / M/s Serum institute of India Ltd / 57239 / Clarification letters
2 / M/s Dr. Reddy’s Laboratories Limited / 797 / Clarification letter
3 / M/s Roche Products India Pvt Ltd / 5474 / Clarification letter
4 / M/s Prosper channel Life Sciences India Pvt, Ltd / 6789 / Clarification letter
NEW DRUG
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
/ M/s. Intas Pharmaceuticals / - / Clarification Letter
/ Dr. Ramesh Agarwal, AIIMS / - / Clarification Letter
/ M/s. Sanofi / - / Clarification Letter (2)
/ M/s. UCB India / Clarification Letter
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUS
/ M/s. B. Braun Medical (India) Pvt. Ltd. / 4984 / Approval (R-E-RC)
/ M/s. Depuy Medical Pvt. Ltd. / 5586 / Approval (F-IL)
/ M/s. Wewin Enterprises. / 4752 / Approval (F-IL)
/ M/s. Johnson & Johnson Ltd. / 3055 / Approval (R-IL)
/ M/s. Abbott Healthcare Pvt. Ltd. / 52058 / Approval (E-IL)
/ M/s. B. Braun Medical (India) Pvt. Ltd. / 38642 / Approval (R-E-IL)
/ M/s. Biotronik Medical Devices Pvt. Ltd. / 63700 / Clarification Letter
/ M/s. Boston Scientific India Pvt. Ltd. / 3636 / Clarification Letter
/ M/s. Covidien Healthcare India Pvt. Ltd. / 46235 / Clarification Letter
/ M/s. Medicare Distributors. / 4264 / Clarification Letter
/ M/s. Organon (India) Pvt. Ltd. / 47734 / Clarification Letter
/ M/s. Rajnikant & Brothers. / 4265 / Clarification Letter
/ M/s. Shubham Enterprises. / 4268 / Clarification Letter
/ M/s. Smith & Nephew Healthcare Pvt. Ltd. / 37176 / Clarification Letter
/ M/s. Venus Medical Products. / 5159 / Clarification Letter
/ The Commissioner, Gujarat (CLAA)
M/s. Meril Healthcare Pvt. Ltd., Vapi (CLAA) / FTS-10014 / Clarification Letter
/ The Drugs Controller, Delhi
The Drugs Controller, Uttar Pradesh
The Drugs Controller, Uttrakhand
The Drugs Controller, Bihar / Nil / Clarification Letter
/ The Deputy Drugs Controller (I), West Zone, Mumbai
The Deputy Drugs Controller (I), South Zone, Chennai
The Deputy Drugs Controller (I), East Zone, Kolkata
The Deputy Drugs Controller (I), Hyderabad / Nil / Clarification Letter
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS
/ M/s. Bhat Bio-Tech India (P) Ltd. / 5011 / Approval (IL)
WRITTEN CONFIRMATION
S.No. / Firm Name / Status
1. / M/s. Teva API India Ltd., / WC Letter
2. / M/s. Hemmo Pharmaceuticals Pvt. Ltd., / Clarification Letter
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT
/ M/s. Micro Labs Ltd., / 31131 / Clarification Letter
/ M/s. Sain Medicaments Pvt. Ltd., / 49710 / Clarification Letter
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter
1. / M/s. BIOCAD / 5941 / CT NOC Approval Letter
2. / M/s. B. J. Medical College / 4720 / Clarification Letter
3. / M/s. Siro / 55460 / Clarification Letter
4. / M/s. A. Menarini / Clarification Letter
5. / M/s. Roche / 1761 / TL Approval Letter
6. / M/s. Pfizer / 65096 / Amendment in TL
7. / M/s. Novartis / 7921 / Amendment in TL
8. / M/s. INC Research / 38373 / Clarification Letter
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter
/ M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 014 / 3244 / Approval Letter
/ M/s. APL Research Centre, Hyderabad-500 090 / 1432 / Approval Letter
/ M/s. APL Research Centre, Hyderabad-500 090 / 54032 / Approval Letter
/ M/s. APL Research Centre, Hyderabad-500 090 / 1431 / Approval Letter
/ M/s. Azidus Laboratories Ltd., Chennai-600 048 / 2807 / Approval Letter
/ M/s. Cliantha Research Limited, Ahmedabad-380 054 / 2369 / Approval Letter
/ M/s. Cliantha Research Limited, Ahmedabad-380 054 / 3782 / Approval Letter
/ M/s. Cliantha Research Limited, Ahmedabad-380 054 / 55050 / Approval Letter
/ M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 3050 / Approval Letter
/ M/s. Jubilant Life Sciences Limited, Noida-201 301, UP / 55010 / Approval Letter
/ M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 16160 / Approval Letter
/ M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 51388 / Approval Letter
/ M/s. Lupin Bioresearch Center, Pune-411 021 / 59451 / Approval Letter
/ M/s. RA Chem Pharma Ltd., Balanagar, Hyderabad-500 037 / 1643 / Approval Letter
/ M/s. Reliance Life Sciences Pvt. Ltd., Navi Mumbai-400 701 / 7142 / Approval Letter
/ M/s. Torrent Pharmaceuticals Ltd. (Research Centre), Gujarat / 47260 / Approval Letter
/ M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 14820 / Approval Letter
/ M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 55897 / Approval Letter
/ M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 55914 / Approval Letter
/ M/s. VerGo Pharma Research Pvt Ltd, Goa-403 110 / 4242 / Approval Letter
/ M/s. Watson Pharma Private Ltd., Navi Mumbai-400 614 / 2101 / Approval Letter
ONLY TEST LICENCE FOR BE
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter
/ M/s. Axis Clinical Ltd., Hyderabad-500 049 / 63082 / Test Licence
/ M/s. Azidus Laboratories Ltd., Chennai-600 048 / 3157 / Test Licence
/ M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 4338 / Test Licence
/ M/s. Wockhardt Ltd, Aurangabad-431006 / 2538 / Test Licence
NEW DRUG
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
/ M/s. Torrent Pharmacuticals / - / Clarification Letter
WRITTEN CONFIRMATION
S. No / Firm Name / Type of Letter
/ M/s. Granules India Ltd., / Clarification Letter
EXPORT NOC
S. No / Firm Name / Diary No. / Type of Letter
/ M/s. Supriya Lifescience Ltd., / Nil / Approval Letter
/ Sandoz Private Ltd., / 3058 / Approval Letter
IMPORT
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
/ Dr. Reddy's Laboratories Limited / 5567 / Approval Letter
/ Dr. Reddy's Laboratories Ltd. / 5568 / Approval Letter
/ Wallace Pharmaceuticals Pvt. Ltd. / 5684 / Approval Letter
/ Farmachem Life Pvt. Ltd. / 5463 / Approval Letter
/ Add-Biotec / 5453 / Approval Letter
/ Xellia Pharmaceuticals Private Limited / 5617 / Approval Letter
/ Vital Therapeutics And Formulations Pvt. Ltd. / 5838 / Approval Letter
/ Cadila Healthcare Ltd. / 5892 / Approval Letter
/ Cadila Healthcare Ltd. / 5893 / Approval Letter
/ Samarth Lifesciences Pvt.Ltd.(Unit-II) / 5746 / Approval Letter
/ Lupin Limited. / 6030 / Approval Letter
/ Pradipkumar & Co. / 6034 / Approval Letter
/ C.J. Shah & Co. / 6281 / Approval Letter
/ Nandlal Bankatlal Pvt. Ltd. / 6145 / Approval Letter
/ The Madras Pharmaceuticals / 6372 / Approval Letter
/ Pratistha Pharma, / 6245 / Approval Letter
/ Sun Pharmaceutical Industries Ltd., / 6299 / Approval Letter
/ Alkem Laboratories Ltd.(Unit-II), / 6149 / Approval Letter
/ Igenerix Pharma Pvt. Ltd. / 6342 / Approval Letter
/ Alkem Laboratories Ltd. / 6150 / Approval Letter
/ Aquatic Remedies Pvt. Ltd. / 6237 / Approval Letter
/ Aquatic Remedies Pvt. Ltd. / 6238 / Approval Letter
/ C.J. Shah & Co. / 6280 / Approval Letter
/ Indoco Remedies Ltd.(Plant II) / 6172 / Approval Letter
/ Sun Pharmaceutical Laboratories Ltd. / 6298 / Approval Letter
/ Mehta Vet Chem / 6147 / Approval Letter
/ DPB Antibiotics / 6148 / Approval Letter
/ Puja Enterprises / 6146 / Approval Letter
/ Shell-Life Sciences Pvt. Ltd. / 6173 / Approval Letter
/ United Biotech Pvt. Ltd. / 6344 / Approval Letter
/ Pratistha Pharma, / 6244 / Approval Letter
/ Passim Medichem Agencies / 6243 / Approval Letter
/ Vital Therapeutics And Formulations Pvt. Ltd. / 6240 / Approval Letter
/ Aquatic Remedies Pvt. Ltd. / 6239 / Approval Letter
/ Central Drug House / 6235 / Approval Letter
/ Prime Pharmachem / 6242 / Approval Letter
/ Prime Pharmachem / 6241 / Approval Letter
/ Ruskin Chemipharm / 6247 / Approval Letter
/ Ruskin Chemipharm / 6246 / Approval Letter
/ Central Drug House / 6236 / Approval Letter
/ NDS Exports / 6401 / Approval Letter
/ Cadila Healthcare Ltd. / 6515 / Approval Letter
/ Micron Pharmaceuticals / 6388 / Approval Letter
/ Anuh Pharma Ltd., / 6386 / Approval Letter
/ Pratistha Pharma, / 6395 / Approval Letter
/ A. Menarini India Pvt. Ltd. / 6469 / Approval Letter
/ Glenmark Pharmaceuticals Ltd. / 6658 / Approval Letter
/ Glenmark Pharmaceuticals Ltd. / 6657 / Approval Letter
/ Glenmark Pharmaceuticals Ltd. / 6659 / Approval Letter
/ Shell-Life Sciences Pvt. Ltd. / 6559 / Approval Letter
/ Anuh Pharma Ltd., / 6387 / Approval Letter
/ Sun Pharmaceutical Industries Ltd., / 6726 / Approval Letter
/ Sun Pharma Laboratories Ltd. / 6719 / Approval Letter
/ Sun Pharma Laboratories Ltd. / 6727 / Approval Letter
/ Sun Pharmaceutical Industries Ltd. / 6723 / Approval Letter
/ Sun Pharma Laboratories Ltd. / 6720 / Approval Letter
/ Sun Pharma Laboratories Ltd. / 6721 / Approval Letter
/ Sun Pharmaceutical Industries Ltd., / 6724 / Approval Letter
/ Sun Pharma Laboratories Ltd. / 6725 / Approval Letter
/ Unimed Technologies Ltd. / 6722 / Approval Letter
/ Wockhatrdt Ltd. / 8706 / Clarification letter