LETTERS FOR ISSUE ON 15.12.2014
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter1. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 47098 / Test Licence
2. / M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 100 / 46897 / Clarification Letter
3. / M/s. Alkem Laboratories Ltd., Taloja-410 208, Tal: Panvel, Dist: Raigad / 45598 / Test Licence
4. / M/s. Axis Clinical Ltd., Hyderabad-500 049 / 45676 / Approval Letter
5. / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 43114 / Clarification Letter
6. / M/s. Cipla Limited, Mumbai-400 008 / 46660 / Test Licence
7. / M/s. Clinsync Clinical Research Pvt. Ltd., Hyderabad-501 505 / 48364 / Approval Letter
8. / M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 43640 / Approval Letter
9. / M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 43841 / Approval Letter
10. / M/s. Inventia Healthcare Pvt. Ltd., Thane-400 604 / 46490 / Test Licence
11. / M/s. Jubilant Generics Ltd., Noida-201 301, UP / 41841 / Clarification Letter
12. / M/s. Kusum Healthcare Pvt. Ltd., New Delhi-110 020 / 46917 / Test Licence
13. / M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 36569 / Approval Letter
14. / M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 46758 / Clarification Letter
15. / M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 46753 / Approval Letter
16. / M/s. Lupin Limited (Research Park), Pune-411 042 / 45785 / Test Licence
17. / M/s. Lupin Limited (Research Park), Pune-412 115 / 46870 / Approval Letter
18. / M/s. Lupin Limited (Research Park), Pune-412 115 / 46871 / Test Licence
19. / M/s. RA Chem Pharma Ltd., Balanagar, Hyderabad-500 037 / 46980 / Approval Letter
20. / M/s. RA Chem Pharma Ltd., Balanagar, Hyderabad-500 037 / 46981 / Approval Letter
21. / M/s. Sitec Labs Pvt Ltd, Navi Mumbai-400701 / 46918 / Clarification Letter
22. / M/s. Sitec Labs Pvt Ltd, Navi Mumbai-400701 / 46919 / Approval Letter
23. / M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 43303 / Test Licence
24. / M/s. Synchron Research Services Pvt. Ltd., Ahmedabad-380 059 / 47921 / Approval Letter
25. / M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 46849 / Rejection Letter
26. / M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 46863 / Approval Letter
27. / M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 46847 / Approval Letter
28. / M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400614 / 46995 / Clarification Letter
29. / M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400614 / 46994 / Approval Letter
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Bard India Healthcare Pvt. Ltd. / 34979 / Approval (F-RC)
2. / M/s. Bard India Healthcare Pvt. Ltd. / 34979 / Approval (F-IL)
3. / M/s. Spark Peripheral Technologies / 46637 / Approval (F-RC)
4. / M/s. Spark Peripheral Technologies / 46637 / Approval (F-IL)
5. / M/s. Edwards Lifesciences (I) Pvt. Ltd. / 40003 / Approval (R-R-RC)
6. / M/s. Edwards Lifesciences (I) Pvt. Ltd. / 40003 / Approval (R-R-IL)
7. / M/s. Boston Scientific India Pvt. Ltd. / 37741 / Approval (R-E-RC)
8. / M/s. Boston Scientific India Pvt. Ltd. / 37741 / Approval (R-E-IL)
9. / M/s. Sark Healthcare Pvt. Ltd. / 44425 / Approval (F-IL)
10. / M/s. Boston Scientific India Pvt. Ltd. / 40493 / Query Letter
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Steranco Healthcare Pvt. Ldt..
All port offices of CDSCO. / 40891 / Approval (IL)
2. / M/s.Euro Diagnostics Systems Pvt. Ltd.
All port offices of CDSCO. / 40735 / Approval (IL)
3. / M/s. Trivitron Healthcare Pvt. Ltd.
All port offices of CDSCO. / 38924 / Approval (TL)
4. / M/s. Trivitron Healthcare Pvt. Ltd.
All port offices of CDSCO. / 38924 / Approval (TL)
5. / M/s. Instrumentation Laboratory India Pvt. Ltd.
All port offices of CDSCO. / 38166 / Approval Letter
6. / M/s. Meril Diagnostics Pvt. Ltd.
The Commissioner, Gujarat / 41444 / Approval Letter
VACCINE DIVISION
S. No. / COMPANY NAME / Dy. No. / STATUS4 / M/s GSK Pharmaceuticals ltd / 40347, / Approval & Clarification Letter
6 / M/s Novo Nordisk India Pvt, ltd / 29905, 13143 / Approval & Clarification Letter
7 / M/s Roche Product India PVt, ltd / 33732, 47585 / Approval & Clarification Letter
8 / M/s Shantha Biotechnics Ltd / 46736, 58978 (fts no) / Approval & Clarification Letter
9 / M/s Pfizer Product India Pvt, Ltd / 42689 / Clarification Letter
10 / M/s Bharat Biotech International ltd / 40937 / Clarification Letter
11 / M/s Sanofi Syntehelabo India Ltd / 46914 / Clarification Letter
12 / M/s Sanofi Pasteur India Pvt, , ltd / 39875 / Clarification Letter
13 / M/s Serum Institute of India ltd / Clarification Letter
14 / M/s Sandor Medicaids Pvt, Ltd / 37889 / Clarification Letter
15 / M/s Lupin ltd / 42162 / Clarification Letter
16 / M/s Dr. Reddy Laboratories ltd / 45436 / Approval Letter
17 / M/s Claris Life science ltd / 52913 / Clarification letter
18 / M/s Johnson & Johnson Ltd / Clarification letter
20 / M/s Stempeutics Research Pvt, ltd / 44803 / Clarification letter
21 / M/s Raut Serum India PVt, ltd / 73378 (fts no) / Approval Letter
22 / M/s Bharat Serum and vaccine ltd / 46708, 55143 (fts no) / Approval Letter
23 / M/s Virchow Biotech pvt, ltd / 44465, 43071 (fts no) / Approval Letter
24 / M/s Zenotech Laboratories ltd / 62003 (fts no) / Approval Letter
25 / M/s Hester Biosciences ltd / 69337 (fts no) / Approval Letter
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER1. / M/S Sun / 42186,43898,46898 / 62308,65073,70023 / Test licence Letter (1)/ Amendment letter(2)
2. / M/s Ipca / 44187 / 65376 / Add. CT. site letter
3. / M/s MSN Organics Pvt. Ltd., / 17701 / - / Approval letter
4. / M/s Intas Pharmaceuticals Ltd., / 14679,40441 / - / Amendment letter/ Approval Letter
5. / M/s Novartis Healthcare Private Limited., / 42899,43271 / 63253,63908 / Amendment letter/ Query Letter
6. / M/s Bayer Pharmaceuticals Pvt. Ltd., / 39862 / 58579 / Amendment letter
7. / M/s Abott Healthcare Pvt. Ltd., / 38982 / 57399 / Query Letter
8. / M/s Zim / - / - / NDAC Letter
9. / M/s Torrent / - / - / NDAC Letter
REGISTRATION
S.no. / Name of applicant / Diary no. / Type of letter1. / Symbio generics india pvt. Ltd. / Nil / Clarification letter
2. / Ucb india pvt. Ltd. / 26364 / Clarification letter
3. / Sundyota numandis pharmaceutical pvt. Ltd. / 28067 / Clarification letter
Written Confirmation
International Cell
S. No / Firm Name / Type of Letter1. / Navdeep Bioceuticals , Baddi, HP / Letter
2. / Mayer Organics, Thane, Maharashtra / Letter
3. / Symbiotech Pharma Labs, M.P. / Letter
4. / M/s Watson Pharma Pvt. Ltd, Thane, Maharashtra. / WC