LETTERS FOR ISSUE ON04.07.2014

SUBSEQUENT NEW DRUG

S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER
M/s Ipca Laboratories / 16976 / 25100 / Amendment l Letter
M/sCipla Ltd., / 15887 / 24582 / Deficiency Letter
M/s Ajanta Pharma Ltd., / 22563 / 33930 / Deficiency Letter

WRITTEN CONFIRMATION

S. No / Firm Name / Type of Letter
1. / M/s. Jubilant Life Sciences Ltd. / Clarification Letter

BE NOC FOR EXPORT

S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter
M/s. Synchron Research Services Pvt. Ltd., Ahmedabad-380 054 / 26506 / Clarification Letter

BE NOC FOR EXPORT

S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter
M/s. Lupin Bioresearch Center, Pune-411 021 / 20137 / Clarification Letter
M/s. Manipal Acunova Ltd., Manipal-576 104 / 21899 / Clarification Letter
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400 614 / 13490 / Clarification Letter

GLOBAL CLINICAL TRIAL

Sr. No. / Name of Firm / Reference No. / Type of Letter
1. / M/s. Biogen Idec / 968 / Change in site Approval
2. / M/s. BMS / 9891 / TL, Change in PI Approval
3. / M/s. Amgen / 8946 / PA Approval
4. / M/s. Sanofi / 24114 / Additional Sites Approval
5. / M/s. Klinera / 19227 / Change in PI Approval
6. / M/s. Kendle / 19000 / PA Approval
7. / M/s. Eli Lilly / 12282 / PA Approval Letter
8. / M/s. Novartis / 7926 / Additional sites Approval

FDC DIVISION

S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT
M/s. Ordain Health Care Global Pvt. Ltd., / 41596 / Clarification Letter

MEDICAL DEVICE

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Faith Biotech Pvt. Ltd. / 19108 / Approval (F-IL)
M/s. Abbott Healthcare Pvt. Ltd. / 19674 / Approval Letter
M/s. Poly Medicure Ltd. / 23028 / Approval Letter
M/s. Meril Life Sciences Pvt. Ltd.
The Deputy Drugs Controller (I), Gujarat
The Commissioner, Gujarat / 1754 / Letter
M/s. Clairvoyance Consulting. / 1038 / Letter
Mr. Samir Mehta, Mumbai. / 17690 / Clarification Letter
M/s. Evolutis India Pvt. Ltd. / 5467 / Query Letter
M/s. Population Services International-India. / 22994 / Query Letter
M/s. Teleflex Medical Pvt. Ltd. / 6100 / Query Letter

DIAGNOSTIC DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Centena Biomed Pvt. Ltd. / 17929 / Approval (IL)
M/s. Centena Biomed Pvt. Ltd. / 17929 / Query Letter
M/s. Medsource Ozone Biomedicals Pvt. Ltd. / 21539 / Approval (IL)
M/s. Sri Balaji Enterprises. / 21252 / Approval (IL)
M/s. Bio-Rad Laboratories (India) Pvt. Ltd. / 20038 / Approval (E-IL)
M/s. Bio-Rad Laboratories (India) Pvt. Ltd. / 19724 / Approval (TL)
M/s. Sumit Biosciences Pvt. Ltd. / FTS-29922 / Approval (TL)
M/s. Roche Diagnostics India Pvt. Ltd. / 21546 / Approval Letter
M/s. Hindustan Antibiotics Ltd. / FTS-32010 / Query Letter
M/s. Iris Healthcare Technologies Pvt. Ltd. / 20292 / Query Letter
M/s. RS Surgicals Pvt. Ltd. / 15496 / Query Letter
M/s. Sysmex India Pvt. Ltd. / 22245 / Query Letter

VACCINE DIVISION

S. No. / COMPANY NAME / Dy.No. / STATUS
1 / M/s Intas Biopharmaceutical ltd / 18689 / Clarification Letter
2 / M/s Reliance Life sciences Ltd / 19682 / Clarification Letter
3 / M/s Xyta Life Sciences Pvt, ltd / 7328 / Clarification Letter
4 / M/s MSD Pharmaceuticals Pvt Ltd / 26610 / Approval letter

COSMETICS DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Marks and spencer Reliance India Private Limited, Mumbai / 15334 / Deficiency Letter
M/s. Trent Limited, Mumbai / 15938 / Deficiency Letter
M/s. Wockhardt Limited, Mumbai / 15931 / Approval Letter
M/s. Aditi Life Sciences, Jaipur / 23187 / Approval Letter
M/s. L’Oreal India Pvt. Ltd. Mumbai / 272, 3252, 4564, 8788, 8702, 8701 / Approval Letter
M/s. Colgate Palmolive (India) Limited, Mumbai / 14600 / Approval Letter

IMPORT

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
Sun Pharmaceutical Industries Ltd. / 25603 / Approval Letter
Mehta Pharmaceutical Industries / 25803 / Approval Letter
Brenntag Ingredients (India) Pvt. Ltd. / 25631 / Approval Letter
Nandlal Bankatlal Pvt. Ltd. / 25632 / Approval Letter
Nandlal Bankatlal Pvt. Ltd. / 25633 / Approval Letter
Torrent Pharamceuticals Ltd. / 25863 / Approval Letter
Finecure Pharmaceuticals Ltd. / 25888 / Approval Letter
Fresenius Kabi Oncology Ltd. / 25835 / Approval Letter
Arun & Company / 25839 / Approval Letter
Pharmachem / 26137 / Approval Letter
Aquatic Remedies Pvt. Ltd. / 26220 / Approval Letter
Kopran Limited / 26277 / Approval Letter
Kopran Limited / 26274 / Approval Letter
Vesta Pharma Chem Pvt. Ltd. / 26297 / Approval Letter
Shell Lifesciences Pvt. Ltd. / 26191 / Approval Letter
Aquatic Remedies Pvt. Ltd. / 26221 / Approval Letter
Vital Therapeutics Ltd. / 26218 / Approval Letter
Samrudh Pharmaceuticals Pvt.Ltd. / 26052 / Approval Letter
Aeon Formulation Pvt. Ltd. / 22544 / Approval Letter
Brawn Laboratories Ltd. / 22965 / Approval Letter
Macleods Pharmaceuticals Limited / 25387 / Approval Letter
Unicure (India) Ltd. / 26365 / Approval Letter
B.Braun Medical (India) Pvt. Ltd. / 6163 / Approval Letter
Sanofi Synthelabo (India) Ltd. / 17395 / Approval Letter
Sanofi India Limited / 17396 / Approval Letter
Jubilant Draximage Ltd. / 18059 / Approval Letter
Jubilant Draximage Ltd. / 18059 / Approval Letter
Mylan Pharmaceuticals Pvt. Ltd. / 21179 / Approval Letter
Pfizer Products India Pvt. Ltd. / 12377 / Approval Letter
Fulford (India) Ltd. / 24328 / Approval Letter
Baxter India Pvt. Ltd / 19629 / Approval Letter

TEST LICENCES

S. No. / Name of the Company / Diary No. / Type of Letter
APL Research Centre / 24841, 36652 / Approval Letter
APL Research Centre / 24836, 36653 / Approval Letter
APL Research Centre / 24837, 36654 / Approval Letter
APL Research Centre / 24838, 36655 / Approval Letter
APL Research Centre / 24839, 36656 / Approval Letter
APL Research Centre / 24840, 36657 / Approval Letter
APL Research Centre / 24833, 36649 / Approval Letter
APL Research Centre / 24834, 36650 / Approval Letter
APL Research Centre / 24835, 36651 / Approval Letter
APL Research Centre / 24850, 36581 / Approval Letter
AstraZeneca Pharma India Ltd / 24486, 36350 / Approval Letter
Bayer Pharmaceuticals Pvt. Ltd / 24893, 36755 / Approval Letter
Cadila Pharmaceuticals Limited / 24867, 36739 / Approval Letter
Cipla Ltd / 24614, 36393 / Approval Letter
Cipla Ltd / 24615, 36319 / Approval Letter
Cipla Ltd / 24612, 36396 / Approval Letter
Cipla Ltd / 24616, 36398 / Approval Letter
Cipla Ltd / 24619, 36405 / Approval Letter
Cipla Ltd / 24618, 36406 / Approval Letter
Cipla Ltd / 24617, 36408 / Approval Letter
Emcure Pharmaceuticals Ltd / 24373, 36410 / Approval Letter
Emcure Pharmaceuticals Ltd / 24372, 36412 / Approval Letter
Emcure Pharmaceuticals Ltd / 24371, 36413 / Approval Letter
Emcure Pharmaceuticals Ltd / 24717, 36590 / Approval Letter
Emcure Pharmaceuticals Ltd / 24710, 36586 / Approval Letter
Encube Ethicals Pvt Ltd / 24796, 36660 / Approval Letter
Encube Ethicals Pvt. Ltd / 24798, 36451 / Approval Letter
Glenmark Generics Ltd / 24599, 36230 / Approval Letter
Glenmark Generics Ltd / 24600, 36226 / Approval Letter
Glenmark Generics Ltd / 24601, 36246 / Approval Letter
Glenmark Generics Ltd / 24596, 36242 / Approval Letter
Glenmark Generics Ltd / 24598, 36233 / Approval Letter
Glenmark Generics Ltd / 24597, 36238 / Approval Letter
Glenmark Generics Ltd / 24982, 36767 / Approval Letter
Glenmark Generics Ltd / 24981, 36769 / Approval Letter
Glenmark Generics Ltd / 24984, 36763 / Approval Letter
Glenmark Generics Ltd / 24986, 36756 / Approval Letter
Glenmark Generics Ltd / 24985,36759 / Approval Letter
Glenmark Generics Ltd / 24983, 36766 / Approval Letter
Glenmark Generics Ltd / 24987, 36753 / Approval Letter
Hetero Labs Ltd / 24722, 36591 / Approval Letter
Ipca Laboratories Limited / 24611, 36399 / Approval Letter
Ipca Laboratories Limited / 24610, 36401 / Approval Letter
Johnson and Johnson Ltd / 24847, 36658 / Approval Letter
Johnson and Johnson Ltd / 24851, 36618 / Approval Letter
Johnson and Johnson Ltd / 24848, 36642 / Approval Letter
Johnson and Johnson Ltd / 24962, 36744 / Approval Letter
Johnson and Johnson Ltd / 24963, 36741 / Approval Letter
Lupin Ltd / 24612, 36395 / Approval Letter
Lupin Ltd / 24814, 36455 / Approval Letter
Lupin Ltd / 24815, 36458 / Approval Letter
Lupin Ltd / 24818, 36464 / Approval Letter
Lupin Ltd / 24816, 36460 / Approval Letter
Lupin Ltd / 24817, 36462 / Approval Letter
Lupin Ltd / 24821, 36470 / Approval Letter
Lupin Ltd / 24820, 36468 / Approval Letter
Lupin Ltd / 24819, 36467 / Approval Letter
Lupin Ltd / 24823, 36645 / Approval Letter
Lupin Ltd / 24822, 36646 / Approval Letter
Lupin Ltd / 24825, 36647 / Approval Letter
Lupin Ltd / 24824, 36648 / Approval Letter
Lupin Ltd / 24960, 36690 / Approval Letter
Macleods Pharmaceuticals Ltd / 24455, 36414 / Approval Letter
Macleods Pharmaceuticals Ltd / 24454, 36416 / Approval Letter
Macleods Pharmaceuticals Ltd / 24456, 36338 / Approval Letter
Medopharm Pvt Ltd / 24849, 36578 / Approval Letter
Micro Labs Ltd / 24868, 36732 / Approval Letter
Micro Labs Ltd / 24870, 36725 / Approval Letter
MSN Laboratories Pvt Ltd / 24735, 36608 / Approval Letter
MSN Laboratories Pvt Ltd / 24737, 36609 / Approval Letter
MSN Laboratories Pvt Ltd / 24736, 36610 / Approval Letter
Mylan Laboratories Ltd / 24433, 36358 / Approval Letter
Mylan Laboratories Ltd / 24432, 36362 / Approval Letter
Piramal Enterprises Ltd / 24792, 36661 / Approval Letter
Ranbaxy Laboratories Ltd / 24758, 36614 / Approval Letter
Shilpa Medicare Ltd / 24920, 36752 / Approval Letter
Sitec Labs Pvt Ltd / 24709, 36585 / Approval Letter
Strides Arcolab Ltd / 24435, 36365 / Approval Letter
Sun Pharmaceutical Industries Ltd / 24783, 36662 / Approval Letter
Sun Pharmaceutical Industries Ltd / 24782, 36663 / Approval Letter
Sun Pharmaceutical Industries Ltd / 24781, 36664 / Approval Letter
Sun Pharmaceutical Industries Ltd / 24780, 36643 / Approval Letter
Sun Pharmaceutical Industries Ltd / 24779, 36644 / Approval Letter
Sun Pharmaceutical Industries Ltd / 24892, 36760 / Approval Letter
Torrent Pharmaceuticals Ltd / 24475, 36344 / Approval Letter
Unichem Laboratories Ltd / 24794, 36449 / Approval Letter
Unichem Laboratories Ltd / 24795, 36448 / Approval Letter
Unichem Laboratories Ltd / 24793, 36659 / Approval Letter
Unique Pharmaceutical Laboratories / 24431, 36354 / Approval Letter
Unique Pharmaceutical Laboratories / 24877, 36764 / Approval Letter
Vivimed labs (Alathur) Pvt Ltd / 24724, 36603 / Approval Letter
Wockhardt Ltd / 24400, 36386 / Approval Letter
Wockhardt Ltd / 24399, 36388 / Approval Letter
Zoetis Pharmaceutical Research Pvt. Ltd / 24939, 36748 / Approval Letter
Zoetis Pharmaceutical Research Pvt. Ltd. / 24941, 36747 / Approval Letter
Zoetis Pharmaceutical Research Pvt. Ltd. / 24940, 36750 / Approval Letter
Tevapharm India Pvt Ltd / 17262, 21131, 17261 , 21132, 12139 , 21130, 9660 , 21129 / Permission Letter