LETTERS FOR ISSUE ON 10.03.2015
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 / 4011 / Test Licence
2. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 4010 / Test Licence
3. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 4013 / Test Licence
4. / M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 48560 / Approval Letter
5. / M/s. Athena Drug Delivery Solutions Pvt. Ltd., Dist. Thane, Maharashtra-421 501 / 3183 / Approval Letter
6. / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 48400 / Approval Letter
7. / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 43114 / Approval Letter
8. / M/s. Biocon Limited, Bangalore-560 100 / 5232 / Amendment Letter
9. / M/s. Cipla Limited, Mumbai-400 013 / 3584 / Test Licence
10. / M/s. Cipla Limited, Mumbai-400 013 / 1738 / Test Licence
11. / M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 4377 / Approval Letter
12. / M/s. Inventia Healthcare Pvt. Ltd., Dist. Thane-421 506 / 5488 / Approval Letter
13. / M/s. Inventia Healthcare Pvt. Ltd., Dist. Thane-421 506 / 4032 / Clarification Letter
14. / M/s. Jubilant Generics Ltd., Noida-201 301, UP / 6322 / Approval Letter
15. / M/s. Jubilant Generics Ltd., Noida-201 301, UP / 51412 / Approval Letter
16. / M/s. Jubilant Generics Ltd., Noida-201 301, UP / 1346 / Approval Letter
17. / M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 76 / Approval Letter
18. / M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 4183 / Approval Letter
19. / M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 51140 / Approval Letter
20. / M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 48054 / Amendment Letter
21. / M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 4389 / Clarification Letter
22. / M/s. Lupin Limited (Research Park), Pune-412 115 / 726 / Test Licence
23. / M/s. Lupin Limited (Research Park), Pune-412 115 / 4369 / Clarification Letter
24. / M/s. Macleods Pharmaceuticals Ltd., Andheri (East), Mumbai-400 059 / 47929 / Approval Letter
25. / M/s. Manipal Acunova Ltd., Mangalore-575 001 / 4598 / Approval Letter
26. / M/s. Novel Clinical Research (India) Pvt. Ltd., Karnataka-560 069 / 1167 / Test Licence
27. / M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 4219 / Clarification Letter
28. / M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400 614 / 4411 / Clarification Letter
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Bard India Healthcare Pvt. Ltd. / 45156 / Query Letter
2. / M/s. Concept Medical Research Pvt. Ltd. / 3336 / Query Letter
3. / M/s. Covidien Healthcare India Pvt. Ltd. / 38544 / Query Letter
4. / M/s. Fresenius Medical Care India Pvt. Ltd. / 49708 / Query Letter
5. / M/s. Faith Biotech Pvt. Ltd. / 39278 / Query Letter
6. / M/s. Hester Diagnostics Pvt. Ltd. / 41365 / Query Letter
7. / M/s. Johnson & Johnson Ltd. / 47917 / Letter
8. / M/s. Meril Life Sciences India Pvt. Ltd. / 49241 / Letter
9. / M/s. Spine Med Systems Pvt. Ltd.
All port offices of CDSCO. / 2215 / Letter
10. / M/s. Stryker India Pvt. Ltd. / 47145 / Query Letter
11. / M/s. St. Jude Medical India Pvt. Ltd. / FTS-70331 / Letter
12. / M/s. Timpac Healthcare Pvt. Ltd. / 44536 / Letter
IMPORT
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / BIOCON LTD./ VXL LIFE SCIENCES / 5561 / CLARIFICATION LETTER
REGISTRATION
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / PFIZER PRODUCTS INDIA PVT. LTD. / 50772 / CLARIFICATION LETTER
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. Boehringer / 49687 / Clarification Letter
2. / M/s. Biogen Idec / 49673 / Clarification Letter
3. / M/s. INC Research / 2122 / Clarification Letter
4. / M/s. Johnson & Johnson / 46402 / Clarification Letter
5. / M/s. Novartis / - / Clarification Letter
VACCINE DIVISION
S. No. / COMPANY NAME / Dy. No. / STATUS1 / M/s Sanofi India Ltd / 37573 / Clarification letter
2 / M/s Johnson & Johnson Pvt, ltd / 3028 / Clarification letter
3 / M/s LG Life Sciences India Pvt, ltd / 1370 / Clarification letter
4 / M/s Eli Lilly and company ( India) Pvt, ltd / 3009, 43922 / Amendment & Clarification letter
5 / M/s Novartis Healthcare Pvt, ltd / 2183, 49305 / Clarification letter
6 / M/s Boehringer Ingelheim India Pvt, ltd / 49069, 2136 / Clarification letter
7 / M/s Zoetis India ltd / 166 / Amendment letter
8 / M/s Organon India Pvt, ltd / 51071 / Clarification letter
9 / M/s Roche Products (India) pvt, ltd / 60217 / Clarification letter
10 / M/s Chiron Behring Vaccine Pvt, ltd / Clarification letter
11 / M/s Merck Specialties Pvt, ltd / 48919, / Clarification & Acknowledge letter
LVP DIVISION
S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS01 / M/s. Shri Krishna Keshav Laboratories Ltd., Gujarat / 4962, 54433, 23838 / Approval
02 / M/s. Unique Pharmaceuticals Ltd., Gujarat / 8564 / Approval
03 / M/s. Bal Pharma Ltd., Maharashtra / 8588 / Approval
04 / M/s. Eurolife Healthcare (P) Ltd., Haridwar / 7280 / Approval
05 / M/s. Aishwarya Healthcare, H.P. / 6886 / Approval
06 / M/s. Aurobindo Pharma Ltd., A.P. / 8102, 8109 / Approval