LETTERS FOR ISSUE ON05.12.2014
Vaccine Division
S. No. / COMPANY NAME / Dy. No. / STATUS1 / M/s Intas Pharmaceuticals ltd / 42597, 60647 (fts no) / Approval Letter
2 / M/s Global Hospital / 39319, 57930 (fts no) / Clarification letter
3 / M/s Wyeth Ltd / Clarification letter
4 / M/s GSK Asia Pvt, Ltd / 41752, 41751,26420 / Approval Letter
5 / M/s Sanofi India Ltd / 40776, 40600 / Approval Letter
6 / M/s Panacea Biotech ltd / 38578, 40022, 42608, 32736, 38256 / Approval & Clarification letter
7 / M/s Roche Products India Pvt, ltd / 30302, 44398 / Approval & Clarification letter
8 / M/s Regenerative Medical Services Pvt, ltd / 20581 / Clarification letter
9 / M/s Serum Institute of India Ltd / 44562 / Continuation Letter
10 / M/s Virchow Biotech Pvt, ltyd / 38939 / Approval Letter
11 / M/s Paviour Pharmaceuticals Pvt, ltd / 10013 / Clarification letter
12 / M/s Alpha Drugs / Approval Letter
13 / M/s EliLilly and company India Pvt, ltd / 11901 / Approval Letter
14 / M/s Plasmagen Biosciences Pvt, ltd / 38190 / Clarification letter
15 / M/s Synergy diagnostics Pvt ,ltd / 45604 / Permission Letter
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letterM/s. Alkem Laboratories Ltd., Taloja-410 208, Tal: Panvel, Dist: Raigad / 45611 / Clarification Letter
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 46089 / Approval Letter
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 46093 / Test Licence
M/s. Axis Clinicals Ltd., Hyderabad-500 049 / 44754 / Clarification Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 45496 / Approval Letter
M/s. Drug Monitoring Research Institute (P) Ltd., Navi Mumbai-400 701 / 47734 / Approval Letter
M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 46051 / Approval Letter
M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 46049 / Approval Letter
M/s. Jubilant Generics Ltd., Noida-201 301, UP / 45910 / Approval Letter
M/s. Jubilant Generics Ltd., Noida-201 301, UP / 45909 / Approval Letter
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 45716 / Approval Letter
M/s. LifeSan Clinical Research, Mumbai-400 055 / 45889 / Test Licence
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 45561 / Rejection Letter
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 43319 / Approval Letter
M/s. Lupin Limited (Research Park), Pune-411 042 / 46022 / Approval Letter
M/s. Lupin Limited (Research Park), Pune-411 042 / 45781 / Test Licence
M/s. Lupin Limited (Research Park), Pune-411 042 / 45782 / Test Licence
M/s. Norwich Clinical Services Pvt. Ltd., Bangalore-560 034 / 45887 / Approval Letter
M/s. Ranbaxy Laboratories Ltd., New Delhi / 46052 / Approval Letter
M/s. Sipra Labs Limited, Hyderabad-500 018 / 46426 / Approval Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 37551 / Rejection Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 45870 / Approval Letter
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400614 / 45752 / Rejection Letter
Written Confirmation
International Cell
S. No / Firm Name / Type of Letter1. / M/s. Pioneer Agro Industries, Plot no.6,7,8,20, Kalagaon, Thane-Maharashtra / Letter
2. / M/s Mehta API Pvt Ltd. Palghar, Maharashtra / Letter
3. / Lupin Limited block-21, Dabhasa, Gujrat / Letter
Vaccine Division
S. No. / COMPANY NAME / Dy. No. / STATUS1 / M/s Regenerative Medical Services Pvt, Ltd / 47277 / Clarification letter
2 / M/s Roche Products India Pvt, ltd / 21174 / Clarification letter
4 / M/s GSK Pharmaceuticals , Ltd / 36309 / Clarification letter
5 / M/s Hetero Drugs Ltd / Clarification letter
6 / M/s Indian Immunologicals Ltd / Clarification letter
Medical Device
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. Atlantic Pharmaceuticals. / 45465 / Approval (F-IL)
Global Clinical Trial
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. George Clinical India / - / Clarification letter