LETTERS FOR ISSUE ON23.05.2014

GLOBAL CLINICAL TRIAL

Sr. No. / Name of Firm / Reference No. / Type of Letter
1. / M/s. PRA / 1475 / Additional sites Approval/Clarification Letter
2. / M/s. Roche / 1761/4576 / Clarification Letter
3. / M/s. Pfizer / 62704 / Clarification Letter
4. / M/s. INC Research / 19760 / TL Approval Letter
5. / M/s. Amgen / 19612 / TL Approval Letter

BE NOC FOR EXPORT

S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter
M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 014 / 13609 / Clarification Letter
M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 13838 / Clarification Letter
M/s. Cipla Limited, Mumbai-400 008 / 15818 / Clarification Letter
M/s. LifeSan Clinical Research, Mumbai-400 055 / 11701 / Clarification Letter

COSMETICS DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Aero Pharma(Silvassa) / 12667 / Deficiency Letter
M/s. Revigen Medicare Pvt. Ltd, Mumbai / 12993 / Deficiency Letter
M/s. Beauty Concepts Pvt. Ltd, Kolkata / 11934 / Deficiency Letter
M/s. Satguru Impex, Chennai / 13394 / Deficiency Letter
M/s. Cadila Healthcare Limited, Gujarat / 13029 / Deficiency Letter

MEDICAL DEVICE

S.NO. / COMPANY NAME / DIARY NO / STATUS
The State Drugs Controller & Licensing Authority, Haryana (CLAA)
The Deputy Drugs Controller (I), Ghaziabad (CLAA)
(M/s. Harsoria Healthcare Pvt. Ltd.,) / 74341 / Approval Letter

DIAGNOSTIC DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Roche Diagnostic India Pvt. Ltd. / FTS-18650 / Query Letter

BIOLOGICAL DIVISION

S. No. / COMPANY NAME / Dy.No. / STATUS
1 / M/s Zenotech Laboratories Ltd / 20073 (fts no) / Approval letter

SUBSEQUENT NEW DRUG

S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER
M/s Zim Laboratories Ltd. / 57913 / 80719 / Deficiency Letter

FDC DIVISION

S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT
M/s. IPCA Laboratories Ltd. / 10922 / Clarification Letter
M/s. Bayer Pharmaceuticals Pvt. Ltd., / 54007 / Clarification Letter
M/s. Rexer Pharma Pvt. Ltd., / 44343 / Clarification Letter
M/s. Provini Animal Nutrition India (P) Ltd., / 46756 / Letter
M/s. Restech Pharma / 43112 / Clarification Letter
M/s. Shiva Biogenetics Pharmaceuticals Pvt Ltd., / 42521 / Clarification Letter
M/s. Vance & Health Pharmaceuticals Pvt. Ltd., / 44370 / Clarification Letter
M/s. Vance & Health Pharmaceuticals Pvt. Ltd., / 44377 / Clarification Letter
M/s. Akums Drugs & Pharmaceuticals Ltd., / 36398 / Letter
M/s. Akums Drugs & Pharmaceuticals Ltd., / 39173 / Letter
M/s. Akums Drugs & Pharmaceuticals Ltd., / 45803 / Letter
M/s. Akums Drugs & Pharmaceuticals Ltd., / 38900 / Clarification Letter
M/s. Ravenbhel Healthcare Pvt .Ltd., / 43543 / Clarification Letter
M/s. Surien Pharmaceuticals (P) Ltd., / 40799 / Clarification Letter
M/s. Theon Pharmaceuticals Ltd., / 10256 / Clarification Letter
M/s. Mylan Laboratories Ltd., / 17424 / Clarification Letter
M/s. Synokem Pharmaceuticals Pvt. Ltd., / 41518 / Clarification Letter
M/s. Synokem Pharmaceuticals Pvt. Ltd., / 41514 / Clarification Letter
M/s. Synokem Pharmaceuticals Pvt. Ltd., / 42935 / Clarification Letter
M/s. Livin Formulations, / 43579 / Clarification Letter
M/s. Livin Formulations, / 43574 / Clarification Letter
M/s. Pristine Lifesciences / 43643 / Clarification Letter
M/s. Meditek India / 43416 / Clarification Letter
M/s. Micro Labs Ltd., / 37296 / Letter
M/s. Allergan India Pvt. Ltd., / 13326 / Letter
M/s. Huvepharma SEA (Pune) Pvt. Ltd., / 6448 / Clarification Letter
M/s. Emcure Pharmaceuticals Ltd., / 1406 / Letter
M/s. Associate Biotech, / 41575 / Clarification Letter
M/s. Unibiotech Formulations / 43438 / Clarification Letter
M/s. Sunways (India ) Pvt. Ltd., / 40938 / Clarification Letter
M/s. Sunways (India ) Pvt. Ltd., / 40938 / Clarification Letter
M/s. RPG Life Sciences Ltd., / 42467 / Clarification Letter
M/s. Riyavin Bio-Research, / 42988 / Clarification Letter
M/s. Sunrise International Labs Ltd., / 44333 / Clarification Letter
M/s. Aurochem Laboratories (I) Pvt. Ltd., / 43003 / Clarification Letter
M/s. Dr. Reddy’s Laboratories / 40733 / Clarification Letter
M/s. Vivek Pharma (India) Ltd., / 46772 / Letter
M/s. Wallace Pharmaceuticals Pvt. Ltd., / 41769 / Clarification Letter
M/s. Abbott Healthcare Pvt. Ltd., / 14968 / Clarification Letter
M/s. Parnax Lab Ltd., / 42281 / Clarification Letter
M/s. J. B. Chemicals & Pharmaceuticals Ltd., / 9899 / Clarification Letter
M/s. Nanz Med Sceince Pharma (P) Ltd., / 10732 / Clarification Letter
M/s. Zota Healthcare Ltd., / 10439 / Clarification Letter
M/s. Smith & Kenner Pharmaceuticals (P) Ltd., / 16302 / Clarification Letter
M/s. Merck Ltd., / 16668 / Clarification Letter
M/s. Acme Formulations Pvt. Ltd., / 39976 / Letter
M/s. Zuventus Healthcare Ltd., / 9248 / Clarification Letter
M/s. Aristo Pharmaceuticals / 6066 / Clarification Letter
M/s. Wyeth Ltd., / 11380 / Clarification Letter
M/s. Eastern Drug / 81272 / Clarification Letter
M/s. Centaur Pharmaceuticals / Nil / NDAC Letter
M/s. Themis Medicare / Nil / 2 NDAC Letter
M/s. Akums Drugs & Pharmaceuticals Ltd., / Nil / NDAC Letter
M/s. Troikaa Pharmaceuticals / Nil / NDAC Letter
M/s. Inventia Healthcare / Nil / NDAC Letter
M/s. Sristek Clinical Research Solutions Ltd., / 14220/12648 / 2 Approval Letter
M/s. Fresenius Kabi (I) Pvt. Ltd., / 14220/12648 / 2 Approval Letter

Medical Device

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Abbott Healthcare Pvt. Ltd. / 64973 / Approval (F-RC)
M/s. Cambindia Biotech Kits Pvt. Ltd. / 14252 / Approval (F-RC)
M/s. Johnson & Johnson Ltd. / 65060 / Approval (F-RC)
M/s. Johnson & Johnson Ltd. / 59279 / Approval (R-RC)
M/s. Cambindia Biotech Kits Pvt. Ltd. / 14252 / Approval (F-IL)
M/s. Johnson & Johnson Ltd. / 65060 / Approval (F-IL)
M/s. Johnson & Johnson Ltd. / 59279 / Approval (R-IL)
Ms. Nikita Sharma, New Delhi / FTS-698 / Clarification Letter
M/s. Becton Dickinson India Pvt. Ltd.
M/s. Becton Dickinson Medical, Singapore
All port offices of CDSCO offices. / 40315 / Approval Letter
The State Drugs Controller & Licensing Authority, Haryana (CLAA)
The Deputy Drugs Controller (I), Ghaziabad (CLAA)
(M/s. Harsoria Healthcare Pvt. Ltd.,) / 74341 / Approval Letter

Diagnostic Division

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Accurex Biomedical Pvt. Ltd. / 15037 / Approval (IL)
M/s. BioMerieux India Pvt. Ltd. / 14957 / Approval (IL)
M/s. Immunoshop India Pvt. Ltd. / 10424 / Approval (IL)
M/s. Roche Diagnostics India Pvt. Ltd. / 12311 / Approval (IL)
M/s. Sowar Pvt. Ltd. / 6640 / Approval (IL)
M/s. Instrumentation Laboratory India Pvt. Ltd. / 11628 / Approval (E-IL)
M/s. Qiagen India (P) Ltd. / 14326 / Approval (TL)
M/s. Trivitron Healthcare Pvt. Ltd. / 11127 / Approval (TL)
M/s. Immunoshop India Pvt. Ltd. / 10424 / Query Letter
M/s. Roche Diagnostic India Pvt. Ltd. / FTS-18650 / Query Letter

TEST LICENCES

S. No. / Name of the Company / Diary No. / Type of Letter
Accutest Research Lab (I) Pvt Ltd / 16965, 25126 / Approval Letter
Agila Specialties Pvt. Ltd., / 16735, 25518 / Approval Letter
Aizant Drug Research Solutions Pvt. Ltd / 17075, 25531 / Approval Letter
Aizant Drug Research Solutions Pvt. Ltd / 17076, 25732 / Approval Letter
Aizant Drug Research Solutions Pvt. Ltd / 17077, 25730 / Approval Letter
Aizant Drug Research Solutions Pvt. Ltd / 17078, 25725 / Approval Letter
Alkem Laboratories Ltd / 16814, 25418 / Approval Letter
APL Research Centre / 16920, 25422 / Approval Letter
Baxter (India) Pvt. Ltd / 16922, 25484 / Approval Letter
Cadila Healthcare Limited. / 17002, 25370 / Approval Letter
Cadila Healthcare Limited. / 17003, 25369 / Approval Letter
Cadila Healthcare Limited. / 17004, 25372 / Approval Letter
Cadila Healthcare Limited. / 17005, 25366 / Approval Letter
Cadila Healthcare Limited. / 17010, 25239 / Approval Letter
Cadila Healthcare Limited. / 17011, 25237 / Approval Letter
Cadila Healthcare Limited. / 17013, 25235 / Approval Letter
Cadila Healthcare Limited. / 17014, 25234 / Approval Letter
Cadila Healthcare Limited. / 17015, 25233 / Approval Letter
Cadila Healthcare Limited. / 17017, 25224 / Approval Letter
Cadila Healthcare Limited. / 17018, 25203 / Approval Letter
Cadila Healthcare Limited., / 17012, 25236 / Approval Letter
Cadila Healthcare Limited., / 17016, 25228 / Approval Letter
Cipla Ltd / 16911, 25442 / Approval Letter
Cipla Ltd / 16912, 25441 / Approval Letter
Cipla Ltd / 16913, 25439 / Approval Letter
Cipla Ltd / 16914, 25437 / Approval Letter
Cipla Ltd / 16915, 25435 / Approval Letter
Cipla Ltd / 16916, 25426 / Approval Letter
Cipla Ltd / 16917, 25433 / Approval Letter
Cipla Ltd / 16918, 25430 / Approval Letter
Cipla Ltd / 16919, 25429 / Approval Letter
Dr Reddy’s Lab Ltd / 16779, 25494 / Approval Letter
Dr Reddy’s Lab Ltd / 16780, 25493 / Approval Letter
Dr Reddy’s Lab Ltd / 16781, 25492 / Approval Letter
Dr Reddy’s Lab Ltd / 16821, 25412 / Approval Letter
Dr Reddy’s Lab Ltd / 16822, 25411 / Approval Letter
Dr Reddy’s Lab Ltd / 16823, 25410 / Approval Letter
Dr Reddy’s Lab Ltd / 16824, 25409 / Approval Letter
Dr Reddy’s Lab Ltd / 16825, 25398 / Approval Letter
Dr Reddy’s Lab Ltd / Approval Letter
Eisai Pharmaceuticals India Pvt Ltd / 16966, 25122 / Approval Letter
Emcure Pharmaceuticals Ltd., / 17007, 25378 / Approval Letter
Getz Pharma Research Pvt. Ltd / 16850, 25329 / Approval Letter
Getz Pharma Research Pvt. Ltd / 16851, 25325 / Approval Letter
Getz Pharma Research Pvt. Ltd / 16852, 25351 / Approval Letter
Getz Pharma Research Pvt. Ltd / 16853, 25354 / Approval Letter
Getz Pharma Research Pvt. Ltd / 16854, 25357 / Approval Letter
Getz Pharma Research Pvt. Ltd / 16855, 25360 / Approval Letter
Indoco Remedies Ltd / 17061, 25153 / Approval Letter
Indoco Remedies Ltd. / 17060, 25155 / Approval Letter
Intas Pharmaceuticals Ltd / 16741, 25510 / Approval Letter
Intas Pharmaceuticals Ltd / 16742, 25506 / Approval Letter
Intas Pharmaceuticals Ltd / 16743, 25503 / Approval Letter
Intas Pharmaceuticals Ltd / 16744, 25500 / Approval Letter
Intas Pharmaceuticals Ltd / 16745, 25498 / Approval Letter
Intas Pharmaceuticals Ltd / 16746, 25497 / Approval Letter
Johnson and Johnson Ltd / 4794, 7280, 18677, 27955 / Approval Letter
Johnson and Johnson Ltd / 4796, 7309, 18677, 27955 / Approval Letter
Kemwell Biopharma Pvt Ltd / 16974, 25526 / Approval Letter
Macleods Pharmaceuticals Ltd / 16856, 25408 / Approval Letter
Macleods Pharmaceuticals Ltd / 16859, 25407 / Approval Letter
Macleods Pharmaceuticals Ltd / 16858, 25406 / Approval Letter
Macleods Pharmaceuticals Ltd. / 16923, 25488 / Approval Letter
MSN Laboratories Pvt Ltd / 16817, 25416 / Approval Letter
MSN Laboratories Pvt Ltd / 16818, 25415 / Approval Letter
MSN Laboratories Pvt Ltd / 16819, 25414 / Approval Letter
MSN Laboratories Pvt Ltd / 16820, 25413 / Approval Letter
Mylan Laboratories Ltd / 16859, 25363 / Approval Letter
Mylan Laboratories Ltd / 16847, 25342 / Approval Letter
Mylan Laboratories Ltd / 16860, 25251 / Approval Letter
Mylan Laboratories Ltd / 16861, 25249 / Approval Letter
Mylan Laboratories Ltd / 16898, 25247 / Approval Letter
Naprod Life Sciences Pvt Ltd / 16921, 25476 / Approval Letter
Novartis Healthcare Pvt Ltd / 17008, 25242 / Approval Letter
Novartis Healthcare Pvt Ltd / 17009, 25240 / Approval Letter
RA Chem Pharma Ltd / 16948, 25150 / Approval Letter
Raptim Research Ltd / 16848, 25347 / Approval Letter
Roche Products (India) Pvt. Ltd / 17056, 25166 / Approval Letter
Roche Products (India) Pvt. Ltd., / 17030, 25170 / Approval Letter
Sentiss Pharma Pvt Ltd / 8873, 13879, 19937, 29707 / Approval Letter
Sequent Research Ltd / 10901, 16723, 19622, 29465 / Approval Letter
SGS India Pvt Ltd / 12517, 19234, 19583, 29409 / Approval Letter
SGS India Pvt Ltd / 12518, 19232, 19584, 29404 / Approval Letter
Shasun Pharmaceuticals Ltd / 17092, 2550 / Approval Letter
Shasun Pharmaceuticals Ltd / 17093, 25547 / Approval Letter
Shasun Pharmaceuticals Ltd / 17094, 25545 / Approval Letter
Shasun Pharmaceuticals Ltd / 17095, 25544 / Approval Letter
Shasun Pharmaceuticals Ltd / 17096, 25543 / Approval Letter
Shasun Pharmaceuticals Ltd / 17101, 25541 / Approval Letter
Sidmak Laboratories India Pvt Ltd / 16849, 25387 / Approval Letter
Sun Pharmaceutical Industries Ltd / 16949, 25143 / Approval Letter
Sun Pharmaceutical Industries Ltd / 16950, 25140 / Approval Letter
Sun Pharmaceutical Industries Ltd / 16962, 25138 / Approval Letter
Suven Life Sciences Ltd / 16730, 25521 / Approval Letter
Torrent Pharmaceuticals Ltd / 16933, 25454 / Approval Letter
Torrent Pharmaceuticals Ltd / 16935, 25161 / Approval Letter
Torrent Pharmaceuticals Ltd., / 16934, 25163 / Approval Letter
UCB India Pvt Ltd / 17053, 25178 / Approval Letter
UCB India Pvt Ltd / 17054, 25185 / Approval Letter
Unimed Technologies Ltd / 16951, 25145 / Approval Letter
USV Ltd / 9015, 13853, 19585, 29411 / Approval Letter
USV Ltd / 9010, 13845, 19585, 29411 / Approval Letter
V-Ensure Pharma Technologies Pvt Ltd / 17006, 25377 / Approval Letter
Watson Pharma Pvt. Ltd / 17111, 25539 / Approval Letter
Watson Pharma Pvt. Ltd / 17112, 25536 / Approval Letter
Watson Pharma Pvt. Ltd / 17113, 25534 / Approval Letter
Watson Pharma Pvt. Ltd / 17114, 25556 / Approval Letter
Encube Ethicals Pvt Ltd / Approval Letter

Export NOC

S. No / Firm Name / Type of Letter / Diary No.
1. / M/s. Ranbaxy Laboratories Limited., / Approval Letter / 22876

NEW DRUG

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
M/s. Torrent Pharmaceuticals / - / Clarification Letter
M/s. Hetero Labs / - / Clarification Letter
M/s. Sanofi / - / Clarification Letter
M/s. Dr. Reddy Labs. / - / Clarification Letter
M/s. Cadila Pharmaceuticals / - / Clarification Letter

BE NOC FOR EXPORT

S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 48542 / Clarification Letter
M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 014 / 17255 / Clarification Letter
M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 014 / 15065 / Approval Letter
M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 14216 / Approval Letter
M/s. APL Research Center, Hyderabad-500 038 / 13172 / Clarification Letter
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 072 / 11991 / Amendment Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 15057 / Approval Letter
M/s. Fortis Clinical Research Ltd., Faridabad-121002 / 11405/11407 / Clarification Letter
M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 13049 / Amendment Letter
M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 10951 / Approval Letter
M/s. GVK Biosciences Pvt. Ltd., Hyderabad-500 038 / 11708 / Clarification Letter
M/s. GVK Biosciences Pvt. Ltd., Hyderabad-500 038 / 14449 / Approval Letter
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 12723 / Approval Letter
M/s. Lok-Beta Pharmaceuticals (I) Pvt. Ltd., Mumbai-400 080 / 9385 / Clarification Letter
M/s. Raptim Research Ltd., Navi Mumbai-400 701 / 11921 / Approval Letter
M/s. Torrent Pharmaceuticals Ltd. (Research Centre), Gujarat / 14200 / Approval Letter
M/s. Watson Pharma Private Ltd., Navi Mumbai-400 614 / 11591 / Amendment Letter
M/s. Wockhardt Ltd., Mumbai-400 051 / 6806 / Clarification Letter

ONLY TEST LICENCE FOR BE

S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 14984 / Test Licence
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 14946 / Test Licence
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Vadodara-390016 / 14983 / Test Licence
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Vadodara-390016 / 14982 / Test Licence
M/s. Clinsync Clinical Research Pvt. Ltd., Hyderabad-501 505 / 14922 / Test Licence
M/s. Manipal Acunova Limited, Manipal -576104 / 14981 / Test Licence
M/s. Manipal Acunova Ltd., Mangalore-575 001 / 14488 / Test Licence
M/s. Torrent Pharmaceuticals Ltd. (Research Centre), Gujarat / 14184 / Test Licence