LETTERS FOR ISSUE ON 03.12.2014
Medical Device
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Bard India Healthcare Pvt. Ltd. / 37403 / Approval (F-RC)
2. / M/s. Bard India Healthcare Pvt. Ltd. / 37403 / Approval (F-IL)
3. / M/s. Smiths Medical India Pvt. Ltd. / 35558 / Approval (F-RC)
4. / M/s. Smiths Medical India Pvt. Ltd. / 35558 / Approval (F-IL)
5. / M/s. B. Braun Medical (India) Pvt. Ltd. / 39470 / Approval (R-RC)
6. / M/s. B. Braun Medical (India) Pvt. Ltd. / 39470 / Approval (R-IL)
7. / M/s. Boston Scientific India Pvt. Ltd. / 37742 / Approval (R-E-RC)
8. / M/s. Boston Scientific India Pvt. Ltd. / 37742 / Approval (R-E-IL)
9. / M/s. Bard India Healthcare Pvt. Ltd. / 27870 / Approval (R-E-RC)
10. / M/s. Bard India Healthcare Pvt. Ltd. / 27870 / Approval (R-E-IL)
11. / M/s. Stryker India Pvt. Ltd. / 40860 / Approval (R-E-RC)
12. / M/s. Stryker India Pvt. Ltd. / 40860 / Approval (R-E-RC)
13. / M/s. Convatec India Pvt. Ltd. / 34177 / Approval (F-IL)
14. / M/s. Appasamy Associates. / 42958 / Approval (R-IL)
15. / M/s. Boston Scientific India Pvt. Ltd. / 334126 / Approval (R-E-IL)
16. / M/s. Cochlear Medical Device Company India Pvt. Ltd. / 39874 / Letter
17. / M/s. Johnson & Johnson Ltd. / 38041 / Letter
18. / M/s. Baxter (India) Pvt. Ltd. / 38613 / Letter
Diagnostic Division
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Euro Diagnostic Systems Pvt. Ltd.
All port offices of CDSCO. / 37834 / Approval (IL)
2. / M/s. Immunoshop India Pvt. Ltd.
All port offices of CDSCO. / 38543 / Approval (IL)
3. / M/s. Beckman Coulter India Pvt. Ltd.
All port offices of CDSCO. / 38666 / Approval (E-IL)
4. / M/s. Roche Diagnostics India Pvt. Ltd.
All port offices of CDSCO. / 39772 / Approval (E-IL)
5. / M/s. Progen SAS Technologies India (P) Ltd. / 29781 / Approval Letter
LVP DIVISION
S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS01 / M/s. Aishwarya Lifesciences, H.P. / 63850 / Approval
02 / M/s. Ultra care International C/o. M/s. Abaris Healthcare Pvt. Ltd., Gujarat / 66521 / Approval
03 / M/s. Denis Chem Lab Ltd., Gujarat / 68458 / Approval
NEW DRUG
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / M/s. Cipla Ltd. / - / Meeting Notice (Pulmonary) 04-12-2014 (2)
2. / Dr. P V Dave / - / Meeting Notice (Antimicrobial) 08-12-2014
3. / M/s. Venus Remidies / - / Meeting Notice (Antimicrobial) 08-12-2014
4. / M/s MSD / - / Meeting Notice (Antimicrobial) 08-12-2014
5. / Dr. Soumya Swaminathan / - / Meeting Notice (Antimicrobial) 08-12-2014
6. / M/s. Novartis / - / Meeting Notice (Antimicrobial) 08-12-2014
7. / M/s. Torrent / - / Meeting Notice (Antimicrobial) 08-12-2014
8. / M/s Johnson & Johnson / - / Meeting Notice (Antimicrobial) 08-12-2014
9. / M/s. Cadila Pharmaceuticals Ltd / - / Query Letter
10. / M/s Novartis Healthcare Pvt. Ltd / - / Query Letter
TEST LICENCES
S. No. / Name of the Company / Diary No. / Type of Letter1. / Suven Life Sciences Ltd / 69073 / Amendment Letter
2. / Torrent Pharmaceuticals Ltd / 68179 / Amendment Letter
3. / Biogen Idec Biotech India Pvt Ltd / 68177 / Amendment Letter
4. / Sun Pharmaceutical Industries Ltd / 66311 / NOC
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT1. / M/s. Mepromax Lifesciences Pvt. Ltd., / 43241 / Letter
2. / M/s. Famy Care Ltd., / 58226 / Letter
3. / M/s. Mylan Pharmaceuticals Ltd., / Nil / SEC Letter
Global Clinical Trial
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. Novartis / 43560/44597 / Change in Pi & Additional sites Approval
2. / M/s. Boehringer / 42451 / TL & Change in Pi & Additional site Approval Letter
3. / M/s. GSK / 43078 / Clarification Letter
4 / M/s. Virchow / - / Clarification Letter
Vaccine Division
S. No. / COMPANY NAME / Dy. No. / STATUS1 / M/s Biological E. ltd / 36878, 36874 / Approval & Clarification Letter
2 / M/s Unichem Laboratories ltd / 20216, 45108 / Approval & Amendment Letter
3 / M/s Reliance Life Science Pvt. Ltd / 37499 / Approval Letter
4 / M/s USV Ltd / 42057 / Amendment Letter
5 / M/s Bharat Biotech International Ltd / 59906, 59908, 59502 (fts no) / Approval & Clarification Letter
6 / M/s Biovet pvt, ltd / 58366, 58370 (fts no) / Clarification letter