LETTERS FOR ISSUE ON 07.01.2015
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter1. / M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 100 / 45991 / Clarification Letter
2. / M/s. Axis Clinical Ltd., Hyderabad-500 049 / 49360 / Approval Letter
3. / M/s. Cipla Limited, Mumbai-400 013 / 49368 / Test Licence
4. / M/s. Cipla Limited, Mumbai-400 013 / 49367 / Test Licence
5. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 49317 / Rejection Letter
6. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 49316 / Approval Letter
7. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 49483 / Test Licence
8. / M/s. Inventia Healthcare Pvt. Ltd., Thane-400 604 / 49150 / Approval Letter
9. / M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 49366 / Approval Letter
10. / M/s. Lotus Labs Pvt. Ltd., Bangalore-560 034 / 49335 / Approval Letter
11. / M/s. Manipal Acunova Limited, Manipal -576104 / 45872 / Approval Letter
12. / M/s. RA Chem Pharma Ltd., Balanagar, Hyderabad-500 037 / 49084 / Approval Letter
13. / M/s. RA Chem Pharma Ltd., Balanagar, Hyderabad-500 037 / 49137 / Test Licence
14. / M/s. Ranbaxy Laboratories Ltd., Gurgaon-122 015 / 49395 / Test Licence
15. / M/s. Ranbaxy Laboratories Ltd., New Delhi / 45179 / Test Licence
16. / M/s. Raptim Research Ltd., Navi Mumbai-400 701 / 49430 / Approval Letter
17. / M/s. Sipra Labs Limited, Hyderabad-500 018 / 48813 / Clarification Letter
18. / M/s. Sitec Labs Pvt Ltd, Navi Mumbai-400701 / 46918 / Approval Letter
19. / M/s. Sitec Labs Pvt Ltd, Navi Mumbai-400701 / 49394 / Approval Letter
20. / M/s. Strides Arcolab Ltd., Bangalore -560076 / 49284 / Clarification Letter
21. / M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 49332 / Approval Letter
International Cell
S. No / Firm Name / Type of Letter1. / M/s. Symbiotech Pharma Labs Limited, Plot No. 5,6,7, and 8, Pithampur, Distt. Dhar (M.P) / WC Certificate
2. / M/s. Chromo Laboratories India Pvt. Ltd., Plot No. 43 &44, IDA, Patancheru Mandal, Medak Dist. A.P / WC Certificate
3. / M/s. Srikem Laboratories Pvt. Ltd., 17/24, MIDC., Taloja Panvel, Maharastra / WC Certificate & Letter
4. / M/s. Lupin Limited, Block 21, Dabhasa, Padra taluka, Vadodara, Gujarat / WC Certificate
Medical Device
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. ArthoCare India Medical Device Pvt. Ltd. / 49470 / Approval (F-RC)
2. / M/s. ArthoCare India Medical Device Pvt. Ltd. / 49470 / Approval (F-IL)
3. / M/s. Edwards Lifesciences (India) Pvt. Ltd. / 42722 / Approval (F-RC)
4. / M/s. Edwards Lifesciences (India) Pvt. Ltd. / 42722 / Approval (F-IL)
5. / M/s. Allwin Lifecare. / 48362 / Approval (R-IL)
6. / M/s. Stef Medical Care India Pvt. Ltd.
All zonal / sub-zonal offices of CDSCO. / 11714 / Approval Letter
7. / M/s. Boston Scientific India Pvt. Ltd. / 49881 / Approval Letter
8. / M/s. Baxter (India) Pvt. Ltd. / 39011 / Letter
9. / The State Drugs Controller, Haryana (CLAA)
The Deputy Drugs Controller (I), Ghaziabad (CLAA)
(M/s. Poly Medicure Ltd.) / FTS-62528 / Approval Letter
Global Clinical Trial
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. Accutest / - / Clarification Letter
2. / M/s. PPD / 49019 / Clarification Letter
3. / M/s. Sanofi / 46554/49433 / TL /Change in PI Approval Letter
4. / M/s. Eli Lilly / 48557 / Amendment in PA Approval
5. / M/s. Maya Clinicals / - / Clarification Letters
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT1. / M/s. Sun Pharmaceuticals / 42472 / Amendment Letter
2. / M/s. Novartis Helathcare / 47752 / Amendment Letter
3. / M/s. AstraZeneca Pharma / 45663 / Approval Letter
4. / M/s. Curetech Skincare / 42957 / Approval Letter
5. / M/s. Torrent Pharmaceuticals / 29667 / Approval Letter
6. / M/s. Torrent Pharmaceuticals / 09 / Letter
7. / M/s. Jagannath Chemical / 52758 / Letter
8. / M/s. Ordain Health Care / 36808 / Letter
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER1. / M/s Huvepharma Sea (Pune) Pvt. Ltd., / - / - / Query Letter
Vaccine Division
S. No. / COMPANY NAME / Dy. No. / STATUS1 / M/s Propser Channel Lifesciences India Pvt, Ltd / 44077 / Clarification letter
2 / M/s Datt Mediproducts ltd / 41550 / Approval Letter
3 / M/s Bharat Biotech International Ltd / 38723, 70670 (fts no) / Clarification letter
4 / M/s Serum Institute of India ltd / Clarification letter
5 / M/s Zee Laboratories Ltd / 66204 (fts no) / Clarification letter
6 / M/s Synergy Diagnostics Pvt, ltd / 46261 / Clarification letter
7 / M/s Chiron Behring vaccine pvt, ltd / 47102 / Clarification letter
8 / M/s Roche Products India Pvt, ltd / Clarification letter
9 / M/s Intas Biopharmceuticals ltd / 47756, 18689 / Clarification letter
10 / M/s Indian Immunologicals Ltd / 38248 / Clarification letter
11 / M/s LG Life Sciences India Pvt, ltd / 47036 / Clarification letter
12 / M/s Johnson & Johnson Ltd / 34442 / Clarification letter
13 / M/s Novartis Healthcare Pvt, ltd / Clarification letter
14 / M/s Panacea Biotech ltd / 45811 / Clarification letter
15 / M/s Bharat Serum and vaccine ltd / Clarification letter
16 / Haffkine Biopharmaceuticals ltd / Clarification letter
17 / Serum Institute of india / Clarification letter
18 / Vins Bioproducts ltd / Clarification letter
19 / Virchow biotech pvt, ltd / Clarification letter
20 / M/s Wockhardt Ltd / 21296, 10219 / Approval Letter
COSMETIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. L’Oreal India Pvt. Ltd, Mumbai / 15483, 20296, 23199, 21107, 23793, 42791, 39935, 43708 / Approval Letter
2. / M/s. Baccarose Perfume & Beauty Products Pvt. Ltd, Mumbai / 44541 / Approval Letter
3. / M/s. VLCC Personal Care Ltd, New Delhi / 44446 / Approval Letter
4. / M/s. VLCC Health care Ltd, New Delhi / 45702 / Approval Letter
NEW DRUG
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / M/s. Ajanta Pharma Limited / - / Query Letter
2. / M/s. Mylan India Private Ltd. / - / Qyery Letter (2)