LETTERS FOR ISSUE ON 26.02.2015
NEW DRUG
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTERM/s. Lupin Limited / - / IPC/CT-NOC/BE-NOC Letter (3)
M/s. AstraZeneca Pharma India Ltd / - / Approval Letter
M/s. Natco Pharma Ltd / - / BE-NOC Letter
M/s. Boehringer Ingelheim India Pvt. Ltd. / - / Query Letter
M/s. Emcure Pharmaceuticals Ltd. / - / Query Letter
M/s Novartis Healthcare Pvt Ltd. / - / Query Letter
M/s. Glenmark Pharma Ltd. / - / Query Letter
VACCINE DIVISION
S. No. / COMPANY NAME / Dy. No. / STATUS1 / M/s Novartis Healthcare Pvt, Ltd / 33828 / Clarification letter
2 / M/s Eli Lilly and company India Pvt, ltd / 48863 / Clarification letter
3 / M/s GSK Pharmaceuticals ltd / 2033, 49753, 49754, 48447, 50294 / Approval & Acknowledge letter
4 / M/s Sanofi India ltd / Clarification letter
5 / M/s Sanofi Pasteur India Pvt ,ltd / 50390 / Approval letter
6 / M/s Wockhardt ltd / 65254, 32140, 22767 / Approval letter
7 / M/s Lupin ltd / 42162 / Clarification letter
8 / M/s Bayer Pharmaceutical Pvt, ltd / 46489, / Approval & Clarification letter
9 / M/s Reliance life sciences Pvt, Ltd / 39755, 43500 / Approval letter
10 / M/s Biovet Pvt, ltd / 45679` / Approval letter
11 / M/s Hetero Drugs ltd / 19446, / Approval letter
12 / M/s Hester Biosciences ltd / 984, 983, 982, 981, 980, 979 / Approval letter
13 / M/s Roche Products India Pvt, ltd / 27806 / Approval letter
14 / M/s Cadila Healthcare ltd / Clarification letter
15 / M/s GSK Asia Pvt. Ltd / 4734 / Approval letter
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. Smith & Nephew Healthcare Pvt. Ltd. / 33194 / Approval (R-RC)
M/s. Smith & Nephew Healthcare Pvt. Ltd. / 33194 / Approval (R-IL)
M/s. Johnson & Johnson Ltd. / 45353 / Approval (R-RC)
M/s. Johnson & Johnson Ltd. / 45353 / Approval (R-IL)
M/s. Gale Overseas Trading Pvt. Ltd. / 50054 / Query Letter
The Joint Commissioner (P.D), Pune (CLAA)
The Dy. Drugs Controller (I), Mumbai (CLAA)
(M/s. Poly Bond India Pvt. Ltd.) / FTS-885 / Approval Letter
REGISTRATION
S.no. / Name of applicant / Diary no. / Type of letterAbbott healthcare pvt. Ltd. / 1037 / Clarification letter
Ranbaxy laboratories ltd. / 1104 / Clarification letter
Ruskin chemipharm / 37615 / Clarification letter
Shah tc overseas pvt. Ltd / 44973 / Clarification letter
Sinopharm india pvt. Ltd. / 46631 / Clarification letter
Biocad india pvt. Ltd. / 15 / Clarification letter
Msc chemicals / 49890 / Clarification letter
Dpb antibiotics pvt. Ltd. / 38720 / Clarification letter
Esschem pvt. Ltd. / 39923 / Clarification letter
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTERM/s Wockhardt Limited., / 49747 / 75002 / Deficiency Letter
M/s MSN Laboratories Pvt.Ltd., / 47805 / 71597 / Deficiency Letter
M/s Lincoln Pharmaceuticals Ltd., / 49091 / 73778 / Deficiency / SEC Letter (2)
M/s Torrent Pharmaceutical Ltd., / 51326 / 77495 / Deficiency Letter
M/s Shasun Pharmaceuticals Ltd., / 3719 / 6250 / IPC NOC Letter
M/s Cadila Pharmaceuticals Limited., / 42103 / 62310 / Deficiency Letter
M/s Novartis India Ltd., / 1834, 41631 / 2995, 61621 / Deficiency / IPC NOC Letter (2)
M/s GSK Pharmaceuticals Ltd., / 3015 / 5110 / Deficiency Letter
M/s Virchow Biotech Pvt. Ltd., / 48903 / 73501 / Deficiency Letter
M/s Sun Pharmaceutical Industries Ltd., / 30 / 23 / Deficiency Letter
M/s Ipca Laboratories Ltd., / 49402 / 74275 / Deficiency Letter
M/s Dispo Surgicals, / 73368 / - / Deficiency Letter
M/s NU Therapeutics Pvt. Ltd., / 44976 / 66731 / Deficiency Letter
M/s Alembic Pharmaceuticals Ltd., / 45921 / 68413 / Deficiency Letter
M/s Indoca Remedies Limited., / 47866 / 71474 / Deficiency Letter
M/s Dr. Reddy’s Laboratories Limited., / 33399 / 49238 / Deficiency Letter
M/s Abbott Healthcare Pvt. Ltd., / 43171 / 63910 / Deficiency Letter
M/s Cipla / - / - / SEC Letter
M/s Athena / - / - / SEC Letter
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letterM/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 3361 / Clarification Letter
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 3346 / Approval Letter
M/s. Actimus Biosciences Pvt. Ltd., Visakhapatnam-530 003 / 3392 / Approval Letter
M/s. APL Research Center, Aurobindo Pharma Limited, Hyderabad-500 090 / 2257 / Clarification Letter
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 3464 / Approval Letter
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 3456 / Clarification Letter
M/s. Cipla Ltd., Mumbai-400 008 / 1738 / Clarification Letter
M/s. Cipla Ltd., Mumbai-400 013 / 3344 / Clarification Letter
M/s. Emcure Pharmaceuticals Limited, Pune-411 026 / 2714 / Clarification Letter
M/s. Indoco Remedies Ltd., Navi Mumbai-400 701 / 3393 / Approval Letter
M/s. Inventia Healthcare Pvt. Ltd., Thane (West)-400 604 / 3125 / Approval Letter
M/s. Jubilant Generics Ltd., Noida-201 301, UP / 2193 / Clarification Letter
M/s. Lupin Limited (Research Park), Pune-412 115 / 3404 / Test Licence
M/s. Manipal Acunova Ltd., Mangalore-575 001 / 3511 / Test Licence
M/s. QPS Bioserve India Pvt. Ltd., Hyderabad – 500 037 / 3381 / Approval Letter
M/s. Ranbaxy Laboratories Ltd., Gurgaon-122 015 / 5031 / Test Licence
M/s. Ranbaxy Laboratories Ltd., Gurgaon-122 015 / 2708 / Test Licence
M/s. Ranbaxy Laboratories Ltd., New Delhi / 3889 / Approval Letter
M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 3341 / Approval Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 3103 / Approval Letter
M/s. Wockhardt Limited, Aurangabad-431 006 / 4985 / Test Licence
M/s. Wockhardt Limited, Mumbai-400 051 / 3395 / Clarification Letter
M/s. Wockhardt Limited, Mumbai-400 051 / 2371 / Clarification Letter