LETTERS FOR ISSUE ON25.07.2014

BA/BE DIVISION

S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS
01 / M/s. Semler, Bangalore / 29562 & 44757 / Approval
02 / M/s. Axis Clinical Ltd., Hyderabad – 500 050 / 16036 / Approval
03 / M/s. Sun Pharmaceuticals Industries Ltd, Gujarat / 58261 / Approval
04 / M/s. Torrent Pharmaceuticals Ltd., Gujarat / 25859 / Query
05 / M/s Vimta Labs Limited, Hyderabad / Query

LVP DIVISION

S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS
01 / M/s. Fresenius Kabi, Pune / 35833 / Approval
02 / M/s. Denis Chem, Gujarat / 29247, 29251 & 29245 / Approval
03 / M/s. Global Pharma Healthcare, Tamil Nadu / 19197 / Approval

BE NOC FOR EXPORT

S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter
M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 28355 / Approval Letter
M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 29191 / Approval Letter
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 28663 / Approval Letter
M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 27885 / Approval Letter
M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 27886 / Approval Letter
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 28682 / Clarification Letter
M/s. Cadila Pharmaceutical Ltd., Dholka-387 810, Ahmedabad / 28111 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 28753 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 27264 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 27252 / Approval Letter
M/s. Emcure Pharmaceuticals Limited, Pune-411 026 / 28232 / Approval Letter
M/s. Emcure Pharmaceuticals Limited, Pune-411 026 / 28229 / Approval Letter
M/s. Eugia Pharma Specialities Limited, Hyderabad-500 084 / 28420 / Approval Letter
M/s. GVK Biosciences Pvt. Ltd., Hyderabad-500 038 / 28705 / Approval Letter
M/s. Jubilant Generics Ltd., Noida-201 301, UP / 28691 / Approval Letter
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 28475 / Approval Letter
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 28936 / Approval Letter
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 28235 / Approval Letter
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 034 / 13504 / Approval Letter
M/s. Lupin Bioresearch Center, Pune-411 021 / 28873 / Clarification Letter
M/s. Lupin Bioresearch Center, Pune-411 021 / 28584 / Clarification Letter
M/s. Macleods Pharmaceuticals Ltd., Andheri (East), Mumbai-400 059 / 28995 / Approval Letter
M/s. Micro Therapeutic Research Labs Pvt. Ltd., Chennai-600059 / 29683 / Approval Letter
M/s. Micro Therapeutic Research Labs Pvt. Ltd., Chennai-600059 / 27950 / Approval Letter
M/s. Ranbaxy Laboratories Ltd., New Delhi / 30386 / Approval Letter
M/s. Semler Research Center, Bangalore-560078 / 27773 / Approval Letter
M/s. Therapeutic Drug Monitoring Laboratory, Mumbai-400 022 / 13790 / Approval Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 28862 / Approval Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 28847 / Approval Letter
M/s. Vimta Labs Ltd., Hyderabad-500051 / 28994 / Approval Letter
M/s. Watson Pharma Pvt Ltd., Navi Mumbai-400614 / 28634 / Approval Letter
M/s. Watson Pharma Pvt Ltd., Navi Mumbai-400614 / 28633 / Approval Letter
M/s. Windlas Healthcare Pvt. Ltd., Dehradun-248 110 / 28117 / Amendment Letter

ONLY TEST LICENCE FOR BE

S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter
M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 28025 / Test Licence
M/s. Alkem Laboratories Ltd., Dist: Raigad -410208 / 28725 / Test Licence
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 28661 / Test Licence
M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 27883 / Test Licence
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 28631 / Test Licence
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 28632 / Test Licence
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 29559 / Test Licence
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 28630 / Test Licence
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 23364 / Test Licence
M/s. Famy Care Ltd., Mumbai-400 001 / 28156 / Test Licence
M/s. LifeSan Clinical Research, Mumbai-400 055 / 26980 / Test Licence
M/s. Lotus Labs Pvt. Ltd., Chennai-600 004 / 28207 / Test Licence
M/s. MSN Laboratories Pvt. Ltd., Andhra Pradesh-502 325 / 27000 / Test Licence
M/s. Norwich Clinical Services Pvt. Ltd., Bangalore-560 034 / 28693 / Test Licence
M/s. Norwich Clinical Services Pvt. Ltd., Bangalore-560 034 / 28694 / Test Licence
M/s. Quest Life Sciences (P) Ltd., Chennai-600045 / 29566 / Test Licence
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 27452 / Test Licence
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 30138 / Test Licence

NEW DRUG

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
M/s. Huvepharma SEA (Pune) Pvt. Ltd / - / Letter
Dr. Iqbal Ahamed M. / - / Query Letter
Dr. Ganapathi Suryanarayana / - / Query Letter
Dr. Aurobindo Pharma Ltd / - / Query Letter
Dr. Anupam Sibal / - / Clarification Letter

MEDICAL DEVICE

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Johnson & Johnson Ltd. / 15405 / Approval (F-RC)
M/s. HLL Life Care Ltd. / 26233 / Approval (F-IL)
M/s. Brainware Medical Technologies Pvt. Ltd. / 24460 / Approval (R-IL)
M/s. Regenix Drugs Ltd. / 47735 / Letter
M/s. Regenix Drugs Ltd. / 47735 / Query Letter
M/s. Depuy Medical Pvt. Ltd. / Nil / Query Letter
M/s. Johnson & Johnson Ltd. / 32549 / Query Letter
M/s. Ahujasons Surgicals. / 24875 / Query Letter
M/s. Biotronik Medical Devices India Pvt. Ltd. / 7687 / Query Letter
M/s. B. L. Lifesciences. / 25019 / Query Letter
M/s. Boston Scientific International B.V. / 13673 / Query Letter
M/s. Boston Scientific International B.V. / 12996 / Query Letter
M/s. Becton Dickinson India Pvt. Ltd. / 26230 / Letter
M/s. Covidien Healthcare India Pvt. Ltd. / 12720 / Query Letter
M/s. Globe Bio Medicals. / 9546 / Query Letter
M/s. Stryker India Pvt. Ltd. / 10577 / Query Letter
M/s. Span Healthcare Pvt. Ltd. / 21092 / Query Letter

DIAGNOSTIC DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Roche Diagnostics India Pvt. Ltd. / 22881 / Approval (E-RC)
M/s. Roche Diagnostics India Pvt. Ltd. / 22881 / Approval (E-IL)
M/s. DSS Imagetech Pvt. Ltd. / 19712 / Approval (IL)
M/s. Novo Healthcare Limited. / 22843 / Approval (IL)
M/s. Transasia Bio-Medicals Ltd. / 24212 / Approval (IL)
M/s. Abbott Healthcare Pvt. Ltd. / 23808 / Approval (E-IL)
M/s. Pammvi Exports Pvt. Ltd. / 22503 / Approval (E-IL)
M/s. Anand Brothers. / 24587 / Query Letter
M/s. Anand Brothers. / 24586 / Query Letter
M/s. Hemodiaz Life Sciences Pvt. Ltd. / 24126 / Query Letter
M/s. Krypton Biomedical Pvt. Ltd. / 24162 / Query Letter
M/s. Roche Diagnostics India Pvt. Ltd. / 24238 / Query Letter
M/s. Thermo fisher Scientific India Pvt. Ltd. / 23991 / Query Letter

FDC DIVISION

S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT
M/s. Wockhardt Ltd., / 19642 / Letter
M/s. Akums Drugs & Pharmaceuticals Ltd., / 42836 / Letter
M/s. Akums Drugs & Pharmaceuticals Ltd., / 42831 / Letter
M/s. Akums Drugs & Pharmaceuticals Ltd., / 47158 / Letter
M/s. Akums Drugs & Pharmaceuticals Ltd., / 40521 / Letter
M/s. Akums Drugs & Pharmaceuticals Ltd., / 38221 / Letter
M/s. Embiotic Laboratories (P) Ltd., / 48814 / Letter
M/s. Aeon Formulations Pvt. Ltd., / 44718 / Letter
M/s. Aeon Formulations Pvt. Ltd., / 50400 / Letter
M/s. Aeon Formulations Pvt. Ltd., / 50843 / Letter
M/s. Aeon Formulations Pvt. Ltd., / 20630 / Letter
M/s. Genpharma International Pvt. Ltd., / 43616/17457 / Letter
M/s. Sun Pharmaceuticals Industries Ltd., / 23935 / Letter
M/s. Sun Pharmaceuticals Industries Ltd., / 41161 / Letter
M/s. Centaur Pharmaceuticals Pvt. Ltd., / 41227 / Letter
M/s. Restech Pharma, / 43117 / Letter
M/s. Medicef Pharma, / 42382 / Letter
M/s. Talent Healthcare / 43345 / Letter
M/s. Talent Healthcare / 43343 / Letter
M/s. Macsur Pharma India Pvt. Ltd., / 43211 / Letter
M/s. Gurufcure , / 41947 / Letter
M/s. Noel Pharma India Pvt.Ltd., / 12075 / Letter
M/s. East West Pharma, / 49030 / Letter
M/s. Indoco Remedies Ltd., / 41720 / Clarification Letter
M/s. MDC Pharmaceuticals Pvt. Ltd., / 47608 / Letter
M/s. Cadila Healthcare Ltd., / 63699 / Clarification Letter
M/s. Shiva Biogenetic pharmaceuticals, / 42527 / Letter
M/s. BRD Medilabs, / 30701 / Letter
M/s. Logos Pharma, / 48487 / Clarification Letter

VACCINE DIVISION

S. No. / COMPANY NAME / Dy.No. / STATUS
1 / M/s Bharat Biotech International Ltd / 27996 / Clarification letter
2 / M/s Sandor Medicaids Pvt Ltd / 27876 / Approval letter
3 / M/s Sun Pharmaceuticals Industries Ltd / 23345 / Clarification letter
4 / M/s Ceva (I) Pvt Ltd / Clarification letter
5 / M/s Kemwell Biopharma Pvt, ltd / 22008, 22007 / Clarification letter

BIOLOGICAL DIVISION

S. No. / COMPANY NAME / Dy.No. / STATUS
1 / M/s USV Ltd / 30551, 30553, 30555, 30552, 30554 / Approval letter

RULE-37

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
BAYER PHARMACEUTICALS PVT. LTD. / 20311 / Clarification letter
MSD PHARAMACEUTICALS PVT LTD. / 16342,16804 / 2 Clarification letter
EASAI PHARAMCEUTICALS INDIA PVT. LTD. / 12593,11983,27299 / 3 Clarification letter
USV LTD. / 14723 / Clarification letter
LUNDBACK INDIA PVT. LTD. / 5307 / Clarification letter
PFIZER LTD. / 20606,20605 / 2 Clarification letter
ORGANON INDIA PVT. LTD. / 25085 / Clarification letter
WYETH LTD. / 60488 / Clarification letter
BIDDLE SAWYER LTD. / 19415 / Clarification letter

TEST LICENCES

S. No. / Name of the Company / Diary No. / Type of Letter
Abbott Healthcare Pvt Ltd / 29747, 43885 / Approval Letter
Abhayam Pharmaceuticals Pvt Ltd / 29075, 43029 / Approval Letter
Actavis Pharma Development Centre Pvt Ltd / 29309, 43316 / Approval Letter
Actavis Pharma Development Centre Pvt Ltd / 29308, 43320 / Approval Letter
Actavis Pharma Development Centre Pvt Ltd / 29307, 43322 / Approval Letter
Agila Specialties Pvt. Ltd / 29497, 43650 / Approval Letter
Agila Specialties Pvt. Ltd / 29498, 43648 / Approval Letter
Agila Specialties Pvt. Ltd / 29499, 43645 / Approval Letter
Agila Specialties Pvt. Ltd / 29507, 43642 / Approval Letter
Alembic Pharmaceuticals Ltd / 29218, 43623 / Approval Letter
Alkem Laboratories Ltd / 29083, 43035 / Approval Letter
Alkem Laboratories Ltd / 29084, 43034 / Approval Letter
APL Research Centre / 29525, 43627 / Approval Letter
APL Research Centre / 29526, 43624 / Approval Letter
APL Research Centre / 29527, 43620 / Approval Letter
APL Research Centre / 29528, 43616 / Approval Letter
APL Research Centre / 29519, 43633 / Approval Letter
APL Research Centre / 29518, 43629 / Approval Letter
APL Research Centre / 29524, 43630 / Approval Letter
APL Research Centre / 29523, 43604 / Approval Letter
APL Research Centre / 24146, 35660, 31334, 45515 / Approval Letter
Appcure Labs Pvt Ltd / 29093, 43039 / Approval Letter
Asrta Life Care (India) Pvt Ltd / 29138, 42872 / Approval Letter
Astra Life Care (India) Pvt Ltd / 29139, 42865 / Approval Letter
Astra Life Care (India) Pvt Ltd / 29136, 42774 / Approval Letter
Cadila Healthcare Limited / 29483, 43565 / Approval Letter
Cadila Healthcare Ltd / 29143, 42877 / Approval Letter
Cadila Healthcare Ltd / 29144, 42880 / Approval Letter
Cipla Ltd / 29116, 42857 / Approval Letter
Cipla Ltd / 29117, 42843 / Approval Letter
Cipla Ltd / 29115, 42848 / Approval Letter
Cipla Ltd / 28910, 42779 / Approval Letter
Cipla Ltd / 28911, 42788 / Approval Letter
Cipla Ltd / 28944, 42496 / Approval Letter
Cipla Ltd / 28945, 42490 / Approval Letter
Cipla Ltd / 28946, 42486 / Approval Letter
Cipla Ltd / 28948, 42483 / Approval Letter
Cipla Ltd / 29121, 42826 / Approval Letter
Cipla Ltd / 29120, 42830 / Approval Letter
Cipla Ltd / 29119, 42834 / Approval Letter
Cipla Ltd / 29118, 42838 / Approval Letter
CIpla Ltd / 29622, 42809 / Approval Letter
Cipla Ltd / 29109, 43044 / Approval Letter
Cipla Ltd / 29110, 43048 / Approval Letter
Cipla Ltd / 29111, 43048 / Approval Letter
Cipla Ltd / 29112, 43051 / Approval Letter
Cipla Ltd / 29113, 43053 / Approval Letter
Claris Lifesciences Ltd / 29288, 43285 / Approval Letter
Claris Lifesciences Ltd / 29300, 43290 / Approval Letter
Claris Lifesciences Ltd / 29299, 43291 / Approval Letter
Claris Lifesciences Ltd / 29298, 43293 / Approval Letter
Claris Lifesciences Ltd / 29289, 43297 / Approval Letter
Dorizoe Lifesciences Ltd / 29304, 43325 / Approval Letter
Dorizoe Lifesciences Ltd / 29303, 43328 / Approval Letter
Dr. Reddy’s Laboratories Ltd / 28940, 42472 / Approval Letter
Dr. Reddy’s Laboratories Ltd / 28942, 42480 / Approval Letter
Dr. Reddy’s Laboratories Ltd / 28943, 42470 / Approval Letter
Dr. Reddy’s laboratories Ltd / 29077, 43030 / Approval Letter
Emcure Pharmaceuticals Ltd / 29415, 43428 / Approval Letter
Encube Ethicals Pvt. Ltd / 29213, 43202 / Approval Letter
Encube Ethicals Pvt. Ltd. / 29212, 43195 / Approval Letter
Fresenius Kabi Oncology Ltd / 29391, 43575 / Approval Letter
Fresenius Kabi Oncology Ltd / 29484, 43597 / Approval Letter
Galderma India Pvt Ltd / 29076, 43027 / Approval Letter
Gland Pharma Ltd / 29131, 42762 / Approval Letter
Gland Pharma Ltd / 29130, 42758 / Approval Letter
Gland Pharma Ltd / 29129, 42732 / Approval Letter
Hetero Labs Ltd / 29217, 43275 / Approval Letter
Hetero Labs Ltd / 29214, 43283 / Approval Letter
Hetero Labs Ltd. / 29446, 43664 / Approval Letter
Indoco Remedies Ltd / 14635, 22216, 30764, 45941 / Approval Letter
Jubilant Generics Ltd / 29347, 43312 / Approval Letter
Jubilant Life Sciences Ltd / 22511, 33216, 30730, 45914 / Approval Letter
Jubilant Life Sciences Ltd / 27019, 39745, 31289, 45622 / Approval Letter
KMS Health Center Pvt Ltd / 27656, 40879, 30957, 45513 / Approval Letter
Kusum Healthcare Pvt. Ltd / 29476, 43477 / Approval Letter
Lupin Ltd / 29271, 43208 / Approval Letter
Lupin Ltd / 29274, 43223 / Approval Letter
Lupin Ltd / 27275, 43212 / Approval Letter
Lupin Ltd / 29273, 43227 / Approval Letter
Lupin Ltd / 29272, 43231 / Approval Letter
Lupin Ltd / 29270, 43238 / Approval Letter
Lupin Ltd / 29269, 43242 / Approval Letter
Mylan Laboratories Ltd / 29480, 43470 / Approval Letter
Mylan Laboratories Ltd / 29481, 43659 / Approval Letter
Mylan Laboratories Ltd / 27255, 40290, 30954, 45495 / Approval Letter
Novartis Healthcare Pvt Ltd / 29458, 43504 / Approval Letter
Novartis Healthcare Pvt Ltd / 29459, 43502 / Approval Letter
Novartis Healthcare Pvt Ltd / 29457, 43663 / Approval Letter
Novartis Healthcare Pvt Ltd / 29461, 43500 / Approval Letter
Onco Therapies Ltd / 29508, 43639 / Approval Letter
RA Chem Pharma Ltd / 28913, 42313 / Approval Letter
RA Chem Pharma Ltd / 28914, 42309 / Approval Letter
Rusan Pharma Ltd / 29529, 43561 / Approval Letter
Sanofi-Synthalbo (India) Ltd / 29127, 42801 / Approval Letter
Sanofi-Synthelabo (India) Ltd / 29128, 42794 / Approval Letter
Sanofi-Synthelabo (India) Ltd / 29329, 43313 / Approval Letter
Sanofi-Synthelabo (India) Ltd / 29328, 43314 / Approval Letter
Sanofi-Synthelabo (India) Ltd / 29327, 43315 / Approval Letter
Strides Arcolab Ltd / 29496, 43653 / Approval Letter
Sun Pharma Advanced Research Company Ltd / 29245, 43256 / Approval Letter
Sun Pharmaceutical Industries Ltd / 29443, 43669 / Approval Letter
Sun Pharmaceutical Industries Ltd / 29444, 43667 / Approval Letter
Sun Pharmaceutical Industries Ltd / 29442, 43671 / Approval Letter
Syngene International Ltd / 29148, 42885 / Approval Letter
Teva API India Ltd / 29530, 43552 / Approval Letter
Teva API India Ltd / 29531, 43547 / Approval Letter
Teva API India Ltd / 29532, 43541 / Approval Letter
Tevapharm India Pvt. Ltd / 29567, 43461 / Approval Letter
Tevapharm India Pvt. Ltd / 29569, 43454 / Approval Letter
Tevapharm India Pvt. Ltd / 29570, 43439 / Approval Letter
Tevapharm India Pvt. Ltd / 29571, 43447 / Approval Letter
Tevapharm India Pvt. Ltd / 29568, 43450 / Approval Letter
Torent Pharmaceuticls Ltd / 29066, 42936 / Approval Letter
Torrent Pharmaceuticals Ltd / 29067, 42931 / Approval Letter
Torrent Pharmaceuticals Ltd / 29074, 42912 / Approval Letter
Torrent Pharmaceuticals Ltd / 29068, 42923 / Approval Letter
Torrent Pharmaceuticals Ltd / 29065, 42946 / Approval Letter
Torrent Pharmaceuticals Ltd / 29064, 42949 / Approval Letter
V-Ensure Pharma Technologies Pvt Ltd / 29135, 42782 / Approval Letter
Vimta Labs Ltd / 29104, 43041 / Approval Letter
Vivimed Labs (Alathur) Pvt. Ltd / 29392, 43590 / Approval Letter
Watson Pharma Pvt Ltd / 29054, 42938 / Approval Letter
Watson Pharma Pvt Ltd / 29053, 42928 / Approval Letter
Wockhardt Ltd / 29047, 42894 / Approval Letter

COSMETICS DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Lloyds Luxuries Limited, Mumbai / 22567, 22710 / Approval Letter
M/s. Modi Revlon Pvt. Ltd, New Delhi / 19263 / Approval Letter
M/s. Nirjay Impex Pvt. Ltd, Pune / 27124 / Deficiency Letter
M/s. Japan Hair Care Co., Mumbai / 12417 / Deficiency Letter
M/s. Baccarose Perfumes & Beauty Products Pvt. Ltd, Mumbai / 20238 / Deficiency Letter
M/s. Amway India Enterprises Pvt. Ltd, New Delhi / 51529, 1622, 65397, 14110 / Deficiency Letter
M/s. Sr. Simal Soin Skincare Private Limited, New Delhi / 7730, FTS No. 39190 / Deficiency Letter
M/s. Alpine Trade Links, New Delhi / 24479 / Deficiency Letter
M/s. Muk India, Gujarat / 27492 / Approval Letter

GLOBAL CLINICAL TRIAL

Sr. No. / Name of Firm / Reference No. / Type of Letter
1. / M/s. Sanofi / 62450 / Clarification letter
2. / M/s. Nexus / - / Clarification Letter
3. / M/s. PPD / 21834 / Clarification Letter
4. / M/s. Novartis / 62951/62075 / Additional Site Approval /NDAC Follow up Letter/Change in site
5. / M/s. Pfizer / 26326 / CT NOC Approval /Clarification Letter
6. / M/s. Excel Life Sciences / 26927 / Additional Site Approval
7. / M/s. GSK / 17468 / CT NOC Approval
8. / M/s. Sristek / 17857/12557 / Additional sites Approval
9. / M/s. Parexel / 22082 / Clarification Letter
10. / M/s. Clinigene / 11219 / Clarification Letter
11. / M/s. Klinera / 25381 / Site Approval Letter