Letters for Issue on 22.04.2014

LETTERS FOR ISSUE ON 22.04.2014

BE NOC FOR EXPORT

S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter
/ M/s. Alkem Laboratories Ltd, Raigad -410208 / 8107 / Approval Letter
/ M/s. Cliantha Research Limited, Ahmedabad-380 054 / 6565 / Approval Letter
/ M/s. Cliantha Research Limited, Ahmedabad-380 054 / 6564 / Approval Letter
/ M/s. Cliantha Research Limited, Ahmedabad-380 054 / 6223 / Approval Letter
/ M/s. Cliantha Research Limited, Ahmedabad-380 054 / 6873 / Approval Letter
/ M/s. Cliantha Research Limited, Ahmedabad-380 054 / 5249 / Approval Letter
/ M/s. Cliantha Research Limited, Ahmedabad-380 054 / 8605 / Approval Letter
/ M/s. Cliantha Research Limited, Ahmedabad-380 054 / 6442 / Approval Letter
/ M/s. Cliantha Research Limited, Ahmedabad-380 054 / 6707 / Approval Letter
/ M/s. Clinigene International Ltd., Bangalore-560 100 / 9063 / Approval Letter
/ M/s. Dr. Reddy’s Laboratories Ltd., Hyderabad-500 034 / 5688 / Approval Letter
/ M/s. Jubilant Life Sciences Limited, Noida-201 301, UP / 7831 / Approval Letter
/ M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 5325 / Approval Letter
/ M/s. Macleods Pharmaceuticals Ltd., Andheri (East), Mumbai-400 059 / 5417 / Approval Letter
/ M/s. Manipal Acunova Ltd., Mangalore-575 001 / 9065 / Approval Letter
/ M/s. Manipal Acunova Ltd., Mangalore-575 001 / 9064 / Approval Letter
/ M/s. Torrent Pharmaceuticals Ltd. (Research Centre), Gujarat / 5220 / Approval Letter
/ M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 3048 / Clarification Letter
/ M/s. Wockhardt Limited - CPB, Aurangabad-431 210 / 46695 / Amendment Letter

ONLY TEST LICENCE FOR BE

S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter
/ M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 014 / 5710 / Test Licence
/ M/s. Clinsync Clinical Research Pvt. Ltd., Hyderabad-501 505 / 6855 / Test Licence
/ M/s. Jubilant Life Sciences Limited, Noida-201 301, UP / 5901 / Test Licence
/ M/s. LifeSan Clinical Research, Mumbai-400 055 / 6545 / Test Licence
/ M/s. Macleods Pharmaceuticals Ltd., Andheri (East), Mumbai-400 059 / 5847 / Test Licence
/ M/s. Novel Clinical Research (India) Pvt. Ltd., Karnataka-560 069 / 5712 / Test Licence
/ M/s. RA Chem Pharma Ltd., Balanagar, Hyderabad-500 037 / 6458 / Test Licence
/ M/s. Semler Research Center, Bangalore-560078 / 8820 / Test Licence
/ M/s. Unichem Laboratories Ltd., Mumbai-400 102 / 40253 / Test Licence
/ M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 8890 / Test Licence
/ M/s. Wockhardt Research Center, Aurangabad-431 210 / 58770 / Test Licence

MEDICAL DEVICE

S.NO. / COMPANY NAME / DIARY NO / STATUS
/ M/s. India Medtronic Pvt. Ltd. / 6999 / Approval (F-RC)
/ M/s. Covidien Healthcare India Pvt. Ltd. / 58560 / Approval (E-RC)
/ M/s. India Medtronic Pvt. Ltd. / 7012 / Approval (R-E-RC)
/ M/s. India Medtronic Pvt. Ltd. / 41997 / Approval (F-IL)
/ M/s. Phoenix Cardio Care India Pvt. Ltd. / 1621 / Approval (R-IL)
/ M/s. Covidien Healthcare India Pvt. Ltd. / 58560 / Approval (E-IL)
/ M/s. India Medtronic Pvt. Ltd. / 7012 / Approval (R-E-IL)
/ M/s. Bioaide Technologies Pvt. Ltd. / 59483 / Query Letter
/ M/s. Johnson & Johnson Ltd. / 55821 / Query Letter
/ M/s. Johnson & Johnson Ltd. / 55822 / Query Letter
/ M/s. Pharma Leaf India Pvt. Ltd. / 7453 / Query Letter
/ M/s. Meril Endo Surgery Pvt. Ltd. / 5382 / Query Letter

DIAGNOSTIC DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
/ M/s. Rushi Corporation. / 8691 / Approval (R-E-RC)
/ M/s. Sysmex India Pvt. Ltd. / 6887 / Approval (IL)
/ M/s. Athenese Dx Pvt. Ltd. / 8368 / Approval (TL)
/ M/s. Janacare Solutions Pvt. Ltd. / 10617 / Approval (TL)
/ M/s. Alere Medical Pvt. Ltd. / 10027 / Query Letter
/ M/s. Euro Diagnostics Systems Pvt. Ltd. / 9804 / Query Letter
/ M/s. Mamta Hygiene Products Pvt. Ltd. / 8704 / Query Letter
/ M/s. Qiagen India Pvt. Ltd. / 8933 / Query Letter
/ M/s. Werfen Medical India Pvt. Ltd. / 59414 / Query Letter
/ M/s. Meril Diagnostics Pvt. Ltd. / 4320 / Query Letter
/ M/s. Nipro India Corporation Pvt. Ltd. / 9039 / Query Letter
/ M/s. Labx. / 8381 / Approval (IL)

FDC DIVISION

S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT
/ M/s. Healers Lab / 49601 / Clarification Letter
/ M/s. Synokem Pharmaceuticals Pvt. Ltd., / 41506 / Clarification Letter
/ M/s. Synokem Pharmaceuticals Pvt. Ltd., / 41572 / Clarification Letter
/ M/s. Synokem Pharmaceuticals Pvt. Ltd., / 42946 / Clarification Letter
/ M/s. BRD Medilabs / 49047 / Clarification Letter
/ M/s. Psychotropics India Ltd., / 43460 / Clarification Letter
/ M/s. East West Pharma / 49291 / Clarification Letter
/ M/s. Surien Pharmaceuticals (P) Ltd., / 39841 / Clarification Letter
/ M/s. Surien Pharmaceuticals (P) Ltd., / 41246 / Clarification Letter
/ M/s. P & B Pharmaceuticals Ltd., / 48937 / Clarification Letter
/ M/s. Vibro Pharma Pvt. Ltd., / 38945 / Letter
/ M/s. Insat Pharma / 41954 / Letter
/ M/s. Aeon Formulations Pvt. Ltd., / 50400 / Clarification Letter
/ M/s. Aeon Formulations Pvt. Ltd., / 48420 / Clarification Letter
/ M/s. Hetero Labs Ltd., / 40577 / Clarification Letter
/ M/s. GlaxoSmithKline Pharmaceuticals Ltd., / 63965 / Clarification Letter
/ M/s. Akums Drugs & Pharmaceuticals Ltd., / 13263 / Clarification Letter
/ M/s. Unibiotech Formulations / 49465 / Clarification Letter
/ M/s. Unibiotech Formulations / 43433 / Clarification Letter
/ M/s. Talent Healthcare / 43343 / Clarification Letter
/ M/s. Talent Healthcare / 43337 / Clarification Letter
/ M/s. Talent Healthcare / 43346 / Clarification Letter
/ M/s. Talent Healthcare / 43358 / Clarification Letter
/ M/s. Talent Healthcare / 43334 / Clarification Letter
/ M/s. MDC Pharmaceuticals Pvt. Ltd., / 47608 / Clarification Letter
/ M/s. Shiva Biogenetic pharmaceuticals Pvt. Ltd., / 42513 / Clarification Letter
/ M/s. Shiva Biogenetic pharmaceuticals Pvt. Ltd., / 42532 / Clarification Letter
/ M/s. Intas Pharmaceuticals Ltd., / 61581 / Letter
/ M/s. Vertex Pharma Chemicals / 44646 / Clarification Letter
/ M/s. Orbit Lifesciences Pvt. Ltd., / 42931 / Clarification Letter
/ M/s. Elder Pharmaceuticals Ltd., / 42222 / Clarification Letter
/ M/s. Emcee Pharmaceuticals (P) Ltd., / 43019 / Clarification Letter
/ M/s. Wockhardt Ltd., / 41291 / Clarification Letter
/ M/s. CIAN Healthcare Pvt. Ltd., / 49824 / Clarification Letter
/ M/s. Embiotic Laboratories (P) Ltd., / 48814 / Clarification Letter
/ M/s. Vance & Health Pharmaceuticals Pvt. Ltd., / 44364 / Clarification Letter
/ M/s. Ravian Life Sciences Pvt. Ltd., / 43382 / Clarification Letter
/ M/s. Sunrise International Labs Ltd., / 44374 / Clarification Letter
/ M/s. Relax Pharmaceuticals Pvt. Ltd., / 42447 / Clarification Letter
/ M/s. Agron Remedies Pvt. Ltd., / 49700 / Clarification Letter
/ M/s. Jubliant Pharmaceuticals Pvt. Ltd., / 43638 / Letter
/ M/s. West-Coast Pharmaceuticals Works Ltd., / 5819 / Clarification Letter

COSMETIC DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
/ M/s. Conybio Healthcare (India) Pvt. Ltd, Tamilnadu / 8035, 13162 / Deficiency Letter
/ M/s. Nuance Group(India) Pvt. Ltd, Maharashtra / 10507 / Approval Letter
/ M/s. Modicare Limited, New Delhi / 8407 / Deficiency Letter
/ M/s. JCKRC SPA Destination Private Limited, Mumbai / 8618 / Approval Letter

VACCINE DIVISION

S. No. / COMPANY NAME / Dy.No. / STATUS
1 / M/s Bharat Serum and vaccines Ltd / 8874 / Clarification letter
2 / M/s Bharat Biotech International Ltd / Clarification letter
3 / M/s GlaxoSmithKline Asia Pvt Ltd / 7409, 53486 / Clarification letter
4 / M/s Zoetis India Ltd / 10923, 11584 / Clarification letter
5 / M/s Roche Products (India) Pvt Ltd / 6031 / Clarification letter
6 / M/s Biological E. Ltd / Clarification letter
7 / M/s Virbac Animal Health India Ltd / 11205 / Clarification letter
8 / M/s BIO-MED Pvt Ltd / Clarification letter
9 / M/s Reliance Life Science Pvt Ltd / 7732, 12970 / Clarification and approval letter
10 / M/s Shantha Biotech Ltd / 284 / Approval letter

EXPORTS OF BIOLOGICAL SAMPLES

S. No. / COMPANY NAME / Dy.No. / STATUS
1 / M/s Apotex Research Pvt Ltd / 12494, 12495 / Approval letter
2 / M/s Cliantha Research Ltd / 13979, 13980, 13978 / Approval letter
3 / M/s Lamda Therapeutic Research Ltd / 13649, 13650, 12905 / Approval letter
4 / M/s Axis Clinicals Ltd / 14221 / Approval letter

REGISTRATION

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
/ BRISTOL-MAYERS SQUIBB INDIA PVT. LTD. / 14581 / APPROVAL LETTER
/ ESSCHEM PVT. LTD. / 56922 / 2 CLARIFICATION LETTER
/ MODI MUNDIPHARMA PVT. LTD. / 7432 / CLARIFICATION LETTER
/ LUPIN LTD. / 4866 / CLARIFICATION LETTER
/ BRISTOL MAYER SQUIBB INDIA PVT LTD. / 63819 / CLARIFICATION LETTER
/ RUSKIN CHEMIPHARM / 43740 / CLARIFICATION LETTER
/ LUPIN LTD. / 4866 / CLARIFICATION LETTER

RULE-37

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
/ ASTRAZENECA PHARMA INDIA LTD. / 60941 / CLARIFICATION LETTER

GLOBAL CLINICAL TRIAL

Sr. No. / Name of Firm / Reference No. / Type of Letter
1. / M/s. Novo Nordisk / 6332/9183 / TL Approval Letters
2. / M/s. Jubilant Clinsys / 57611 / TL Approval
3. / M/s. BMS / 4610/9892 / TL Approval/Clarification Letter
4. / M/s. St. John’s National Academy / 47646 / TL Approval Letter
5. / M/s. Baxter / 9183 / TL Approval
6. / M/s. Parexel / 11248 / TL Approval Letter
7. / M/s. Max Neeman / 7808 / Export NOC Approval
8. / M/s. Sanofi / 9006/60383 / Additional Site Approval/PA Approval
9. / M/s. Cliantha / 50862 / CT NOC Approval
10. / Ms. Wyeth / - / Clarification Letter
11. / M/s. PPD / 56466 / Clarification Letter
12. / M/s. MSD / - / Clarification Letter

NEW DRUG

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
/ M/s. Shilpa Medicare Ltd. / - / Clarification Letter
/ M/s. Johnson & Johnson Ltd / - / Letter

TEST LICENCES

S. No. / Name of the Company / Diary No. / Type of Letter
/ Agila Specialties Pvt. Ltd / 11390, 17499 / Approval Letter
/ Agila Specialties Pvt. Ltd / 11379, 17502 / Approval Letter
/ Ajanta Pharma Ltd / 10555, 16323 / Approval Letter
/ Ajanta Pharma Ltd / 10556, 16325 / Approval Letter
/ Alembic Pharmaceuticals Ltd / 11301, 17548 / Approval Letter
/ Alembic Pharmaceuticals Ltd / 11319, 17440 / Approval Letter
/ Alembic Pharmaceuticals Ltd / 11318, 17441 / Approval Letter
/ Alembic Pharmaceuticals Ltd / 11317, 17444 / Approval Letter
/ Alembic Pharmaceuticals Ltd / 11316, 17445
/ Alkem Laboratories Ltd / 11117, 17132 / Approval Letter
/ Alkem Laboratories Ltd / 11116, 17133 / Approval Letter
/ Alphamed Formulations Pvt. Ltd / 11296, 17557 / Approval Letter
/ Alphamed Formulations Pvt. Ltd / 11298, 17553 / Approval Letter
/ Alphamed Formulations Pvt. Ltd / 11297, 17555 / Approval Letter
/ Alphamed Formulations Pvt. Ltd / 11295, 17559 / Approval Letter
/ Alphamed Formulations Pvt. Ltd / 11294, 17560 / Approval Letter
/ Amneal Pharmaceuticals Company (I) Pvt Ltd / 11085, 17152 / Approval Letter
/ Amneal Pharmaceuticals Company (I) Pvt Ltd / 11086, 17150 / Approval Letter
/ Apex Laboratories Pvt Ltd / 10975, 16965 / Approval Letter
/ Cadila Healthcare Ltd / 11122, 17137 / Approval Letter
/ Cadila Healthcare Ltd / 11121, 17139 / Approval Letter
/ Cadila Healthcare Ltd / 11123, 17135 / Approval Letter
/ Cadila Healthcare Ltd / 11124, 17134 / Approval Letter
/ Dr. Reddy’s Laboratories Ltd / 11049, 17070 / Approval Letter
/ Dr. Reddy’s Laboratories Ltd / 11053, 17065 / Approval Letter
/ Dr. Reddy’s Laboratories Ltd / 11052, 17068 / Approval Letter
/ Dr. Reddy’s Laboratories Ltd / 11054, 17143 / Approval Letter
/ Emcure Pharmaceuticals Ltd / 11083, 16979 / Approval Letter
/ Emcure Pharmaceuticals Ltd / 11084, 16973 / Approval Letter
/ Emcure Pharmaceuticals Ltd / 11332, 17433 / Approval Letter
/ Emcure Pharmaceuticals Ltd / 11325, 17569 / Approval Letter
/ Emcure Pharmaceuticals Ltd / 11322, 17570 / Approval Letter
/ Emcure Pharmaceuticals Ltd / 11082, 16983 / Approval Letter
/ Emcure Pharmaceuticals Ltd / 11081, 16969 / Approval Letter
/ Getz Pharma Research Pvt Ltd / 11032, 16990 / Approval Letter
/ Getz Pharma Research Pvt Ltd / 11031, 16997 / Approval Letter
/ Getz Pharma Research Pvt Ltd / 11030, 17000 / Approval Letter
/ Getz Pharma Research Pvt Ltd / 10992, 17004 / Approval Letter
/ Inventia Healthcare Pvt. Ltd / 11257, 17434 / Approval Letter
/ Inventia Healthcare Pvt. Ltd / 11234, 17436 / Approval Letter
/ Inventia Healthcare Pvt. Ltd / 11233, 17439 / Approval Letter
/ Inventia Healthcare Pvt. Ltd / 11232, 17467 / Approval Letter
/ Inventia Healthcare Pvt. Ltd / 11231, 17472 / Approval Letter
/ Inventia Healthcare Pvt. Ltd / 11230, 17476 / Approval Letter
/ Inventia Healthcare Pvt. Ltd / 11229, 17478 / Approval Letter
/ Inventia Healthcare Pvt. Ltd / 11228, 17480 / Approval Letter
/ Lupin Ltd / 11302, 17544 / Approval Letter
/ Lupin Ltd / 11305, 17446 / Approval Letter
/ Lupin Ltd / 11304, 17448 / Approval Letter
/ Perrigo Laboratories India Pvt Ltd / 11104, 17111 / Approval Letter
/ Perrigo Laboratories India Pvt Ltd / 11103, 17113 / Approval Letter
/ Perrigo Laboratories India Pvt Ltd / 11112, 17109 / Approval Letter
/ Perrigo Laboratories India Pvt Ltd / 11113, 17107 / Approval Letter
/ Perrigo Laboratories India Pvt Ltd / 11097, 17115 / Approval Letter
/ Perrigo Laboratories India Pvt Ltd / 11098, 17114 / Approval Letter
/ Perrigo Laboratories India Pvt Ltd / 11099, 17106 / Approval Letter
/ Perrigo Laboratories India Pvt Ltd / 11100, 17102 / Approval Letter
/ Perrigo Laboratories India Pvt Ltd / 11101, 17100 / Approval Letter
/ Perrigo Laboratories India Pvt Ltd / 11102, 17095 / Approval Letter
/ Piramal Enterprises Ltd / 11338, 17429 / Approval Letter
/ Piramal Enterprises Ltd / 11337, 17430 / Approval Letter
/ Rubicon Research Pvt. Ltd / 11261, 17562 / Approval Letter
/ Sun Pharmaceutical Industries Ltd / 11160, 17086 / Approval Letter
/ Sun Pharmaceutical Industries Ltd / 11161, 17083 / Approval Letter
/ Sun Pharmaceutical Industries Ltd / 11164, 17078 / Approval Letter
/ Sun Pharmaceutical Industries Ltd / 11162, 17080 / Approval Letter
/ Teva API India Ltd / 11024, 17040 / Approval Letter
/ Teva API India Ltd / 11025, 17037 / Approval Letter
/ Tevapharm India Pvt. Ltd / 11355, 17527 / Approval Letter
/ Tevapharm India Pvt. Ltd / 11354, 17528 / Approval Letter
/ Tevapharm India Pvt. Ltd / 11353, 17530 / Approval Letter
/ Tevapharm India Pvt. Ltd / 11352, 17534 / Approval Letter
/ Tevapharm India Pvt. Ltd / 11351, 17538 / Approval Letter
/ Tevapharm India Pvt. Ltd / 11350, 17540 / Approval Letter
/ Tevapharm India Pvt. Ltd / 11349, 17541 / Approval Letter
/ Tevapharm India Pvt. Ltd / 11348, 17543 / Approval Letter
/ Tevapharm India Pvt. Ltd / 11363, 17516 / Approval Letter
/ Tevapharm India Pvt. Ltd / 11364, 17514 / Approval Letter
/ Tevapharm India Pvt. Ltd / 11365, 17511 / Approval Letter
/ Tevapharm India Pvt. Ltd / 11366, 17510 / Approval Letter
/ Tevapharm India Pvt. Ltd / 11367, 17508 / Approval Letter
/ Tevapharm India Pvt. Ltd / 11378, 17505 / Approval Letter
/ Tevapharm India Pvt. Ltd / 11358, 17518 / Approval Letter
/ Tevapharm India Pvt. Ltd / 11357, 17519 / Approval Letter
/ Tevapharm India Pvt. Ltd / 11356, 17525 / Approval Letter
/ Umedica Laboratories Pvt Ltd / 11134, 17206 / Approval Letter
/ Umedica Laboratories Pvt Ltd / 11133, 17209 / Approval Letter
/ Umedica Laboratories Pvt Ltd / 11135, 17072 / Approval Letter
/ Umedica Laboratories Pvt Ltd / 11140, 17074 / Approval Letter
/ Watson Pharma Pvt Ltd / 11027, 17021 / Approval Letter
/ Watson Pharma Pvt Ltd / 11028, 17015 / Approval Letter
/ Watson Pharma Pvt Ltd / 11029, 17010 / Approval Letter
/ Wintac Limited / 10996, 16941 / Approval Letter
/ Wintac Limited / 10998, 16958 / Approval Letter
/ Wintac Limited / 10995, 16944 / Approval Letter
/ Wintac Limited / 10993, 16951 / Approval Letter
/ Wintac Limited / 10997,16954 / Approval Letter
/ Wintac Limited / 10994, 16948 / Approval Letter
/ Wintac Limited / 10999, 16961 / Approval Letter
/ Zoetis Pharmaceutical Research Pvt. Ltd. / 11259, 17564 / Approval Letter
/ Zoetis Pharmaceutical Research Pvt. Ltd. / 11258, 17567 / Approval Letter