LETTERS FOR ISSUE ON11.09.2014

VACCINE DIVISION

S. No. / COMPANY NAME / Dy.No. / STATUS
1 / M/s USV Ltd / 30214 / Clarification Letter
2 / M/s Wockhardt Research Centre / 31907 / Clarification Letter

GLOBAL CLINICAL TRIAL

Sr. No. / Name of Firm / Reference No. / Type of Letter
1. / M/s. Johnson & Johnson / 33413 / TL Approval Letter
2. / M/s. BMS / 36311 / TL Approval letter
3. / M/s. GSK / 26307 / Clarification Letter

WRITTEN CONFIRMATION

Sr. No / Firm Name / Letter
1. / M/s. Sarv Biolabs Pvt. Limited. / Clarification Letter
2. / M/s. Alchem International Ltd. / 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 / 35859 / Clarification Letter
M/s. Alkem Laboratories Ltd., Taloja-410 208, Tal: Panvel, Dist: Raigad / 35679 / Approval Letter
M/s. Alkem Laboratories Ltd., Taloja-410 208, Tal: Panvel, Dist: Raigad / 35674 / Approval Letter
M/s. Alkem Laboratories Ltd., Taloja-410 208, Tal: Panvel, Dist: Raigad / 35678 / Approval Letter
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 35254 / Approval Letter
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 36218 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 36067 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 35834 / Approval Letter
M/s. Jubilant Generics Ltd., Noida-201 301, UP / 35520 / Approval Letter
M/s. Jubilant Generics Ltd., Noida-201 301, UP / 35871 / Approval Letter
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 35425 / Approval Letter
M/s. Lotus Labs Pvt. Ltd., Chennai-600 004 / 35405 / Clarification Letter
M/s. Lupin Bioresearch Center, Pune-411 021 / 36399 / Approval Letter
M/s. Macleods Pharmaceuticals Ltd., Andheri (East), Mumbai-400 059 / 35805 / Approval Letter
M/s. Macleods Pharmaceuticals Ltd., Andheri (East), Mumbai-400 059 / 35815 / Approval Letter
M/s. Norwich Clinical Services Pvt. Ltd., Bangalore-560 034 / 36611 / Approval Letter
M/s. Sitec Labs Pvt Ltd, Navi Mumbai-400701 / 37611 / Approval Letter
M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 35186 / Approval Letter
M/s. Synchron Research Services Pvt. Ltd., Ahmedabad-380 059 / 36228 / Approval Letter
M/s. Torrent Pharmaceuticals Ltd. (Research Centre), Gujarat / 35685 / Approval Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 36271 / Approval Letter

ONLY TEST LICENCE FOR BE

S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter
M/s. Alkem Laboratories Ltd., Taloja-410 208, Tal: Panvel, Dist: Raigad / 35673 / Test Licecne
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 35669 / Test Licecne
M/s. Cipla Limited, Mumbai-400 008 / 35625 / Test Licecne
M/s. Cipla Limited, Mumbai-400 008 / 35639 / Test Licecne
M/s. Cipla Limited, Mumbai-400 008 / 35640 / Test Licecne
M/s. Lok-Beta Pharmaceuticals (I) Pvt. Ltd., Mumbai-400 080 / 35255 / Test Licecne
M/s. Manipal Acunova Ltd., Manipal AcuNova KMC CPU, Mangalore-575 001 / 36764 / Test Licecne
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 36091 / Test Licecne
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 37306 / Test Licecne
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400614 / 35434 / Test Licecne

FDC DIVISION

S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT
M/s. Intas Pharmaceuticals Ltd., / 29910 / Amendment Letter

MEDICAL DEVICE

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Stryker India Pvt. Ltd. / 22056 / Query Letter
M/s. B. Braun Medical (I) Pvt. Ltd. / 26413 / Query Letter
M/s. Becton Dickinson India Pvt. Ltd. / 13152 / Query Letter
M/s. Edwards Life Sciences (I) Pvt. Ltd. / 41141 / Query Letter
M/s. Optimus Pharma Consulting / 5012 / Query Letter
M/s. HLL Life care Ltd. / 49530 / Query Letter
M/s. Louts Surgicals Pvt. Ltd. / 7071 / Query Letter

DIAGNOSTIC DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Unilab Biosciences Pvt. Ltd. / 31866 / Query Letter
M/s. L B Diagnostics / 29650 / Query Letter
M/s. Biomerieux India Pvt. Ltd. / 31484 / Query Letter

SUBSEQUENT NEW DRUG

S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER
M/s Intas Pharmaceuticals / 29056 / 42997 / Deficiency Letter

TEST LICENCES

S. No. / Name of the Company / Diary No. / Type of Letter
ActavisPharma Development Centre Pvt. Ltd / 35554, 52165 / Approval Letter
ActavisPharma Development Centre Pvt. Ltd / 35555, 52161 / Approval Letter
ActavisPharma Development Centre Pvt. Ltd / 35556, 52158 / Approval Letter
ActavisPharma Development Centre Pvt. Ltd / 35763, 52720 / Approval Letter
ActavisPharma Development Centre Pvt. Ltd / 35761, 52724 / Approval Letter
ActavisPharma Development Centre Pvt. Ltd / 35760, 52728 / Approval Letter
ActavisPharma Development Centre Pvt. Ltd / 35762, 52717 / Approval Letter
Aizant Drug Research Solutions Pvt. Ltd / 35693, 52540 / Approval Letter
Alembic Pharmaceuticals Ltd / 35495, 52115 / Approval Letter
Alembic Pharmaceuticals Ltd / 35483, 52114 / Approval Letter
Alembic Pharmaceuticals Ltd / 35484, 52111 / Approval Letter
Alembic Pharmaceuticals Ltd / 35489, 52110 / Approval Letter
Alembic Pharmaceuticals Ltd / 35493, 52090 / Approval Letter
Alembic Pharmaceuticals Ltd / 35480, 52106 / Approval Letter
Alembic Pharmaceuticals Ltd / 35481, 52105 / Approval Letter
Alembic Pharmaceuticals Ltd / 35491, 52097 / Approval Letter
Alembic Pharmaceuticals Ltd / 35492, 52095 / Approval Letter
Alembic Pharmaceuticals Ltd / 35478, 52082 / Approval Letter
Alembic Pharmaceuticals Ltd / 35479, 52078 / Approval Letter
Alembic Pharmaceuticals Ltd / 35494, 52117 / Approval Letter
Alembic Pharmaceuticals Ltd / 35482, 52102 / Approval Letter
Alembic Pharmaceuticals Ltd / 35490, 52108 / Approval Letter
Alembic Pharmaceuticals Ltd / 35496, 52086 / Approval Letter
Alkem Laboratories Ltd / 35438, 52113 / Approval Letter
AuronextPharmaPvt Ltd. / 35608, 52666 / Approval Letter
Cadila Healthcare Ltd / 35569, 52107 / Approval Letter
Cipla Ltd / 35601, 52697 / Approval Letter
Cipla Ltd / 35602, 52701 / Approval Letter
Cipla Ltd / 35603, 52703 / Approval Letter
Cipla Ltd / 35604, 52709 / Approval Letter
Cipla Ltd / 35605, 52711 / Approval Letter
Cipla Ltd / 35607, 52714 / Approval Letter
Claris Lifesciences Ltd / 35597, 52674 / Approval Letter
Dr. Reddy’s Laboratories Ltd / 35512, 52052 / Approval Letter
Emcure Pharmaceuticals Ltd / 35475, 52234 / Approval Letter
Emcure Pharmaceuticals Ltd / 35471, 52229 / Approval Letter
Emcure Pharmaceuticals Ltd / 35472, 52220 / Approval Letter
Emcure Pharmaceuticals Ltd / 35473, 52213 / Approval Letter
Emcure Pharmaceuticals Ltd / 35470, 52242 / Approval Letter
Emcure Pharmaceuticals Ltd / 35474, 52239 / Approval Letter
Getz Pharma Research Pvt Ltd / 35599, 52641 / Approval Letter
Gland Pharma Ltd / 35531, 52032 / Approval Letter
Glenmark Generics Ltd / 35745, 52514 / Approval Letter
Glenmark Generics Ltd / 35744, 52515 / Approval Letter
Glenmark Generics Ltd / 35743, 52516 / Approval Letter
Glenmark Generics Ltd / 35742, 52519 / Approval Letter
Glenmark Generics Ltd / 35741, 52520 / Approval Letter
Glenmark Generics Ltd / 35740, 52522 / Approval Letter
Glenmark Generics Ltd / 35733, 52523 / Approval Letter
Glenmark Generics Ltd / 35732, 52525 / Approval Letter
Glenmark Generics Ltd / 35731, 52526 / Approval Letter
Glenmark Generics Ltd / 35727, 52614 / Approval Letter
Glenmark Generics Ltd / 35728, 52619 / Approval Letter
Glenmark Generics Ltd / 35729, 52625 / Approval Letter
Glenmark Generics Ltd / 35730, 52631 / Approval Letter
Glenmark Pharmaceuticals Ltd / 35551, 52094 / Approval Letter
Intas Pharmaceuticals Ltd / 35420, 52149 / Approval Letter
Intas Pharmaceuticals Ltd / 35415, 52177 / Approval Letter
Intas Pharmaceuticals Ltd / 35418, 52167 / Approval Letter
Intas Pharmaceuticals Ltd / 35419, 52166 / Approval Letter
Intas Pharmaceuticals Ltd / 35416, 52173 / Approval Letter
Intas Pharmaceuticals Ltd / 35413, 52184 / Approval Letter
Intas Pharmaceuticals Ltd / 35414, 52180 / Approval Letter
Intas Pharmaceuticals Ltd / 35412, 52197 / Approval Letter
Intas Pharmaceuticals Ltd / 35417, 52170 / Approval Letter
Intas Pharmaceuticals Ltd / 35421, 52152 / Approval Letter
Intas Pharmaceuticals Ltd / 35675, 52678 / Approval Letter
Intas Pharmaceuticals Ltd / 35676, 52682 / Approval Letter
Intas Pharmaceuticals Ltd / 35677, 52685 / Approval Letter
Johnson and Johnson Ltd / 35560, 52028 / Approval Letter
Johnson and Johnson Ltd / 35559, 52207 / Approval Letter
Micro Labs Ltd. / 35529, 52339 / Approval Letter
Micro Labs Ltd. / 35530, 52343 / Approval Letter
Micro Labs Ltd. / 35528, 52341 / Approval Letter
Micro Labs Ltd. / 35511, 52347 / Approval Letter
Micro Labs Ltd. / 35536, 52333 / Approval Letter
Novartis Healthcare Pvt Ltd / 35613, 52655 / Approval Letter
Onco Therapies Ltd / 35513, 52056 / Approval Letter
Perrigo Laboratories India Pvt Ltd / 35711, 52550 / Approval Letter
Perrigo Laboratories India Pvt Ltd / 35712, 52552 / Approval Letter
Piramal Enterprises Ltd / 35461, 52194 / Approval Letter
Piramal Enterprises Ltd / 35460, 52201 / Approval Letter
Piramal Enterprises Ltd / 35456, 52189 / Approval Letter
Piramal Enterprises Ltd / 35454, 52187 / Approval Letter
Piramal Enterprises Ltd / 35459, 52182 / Approval Letter
Piramal Enterprises Ltd / 35458, 52181 / Approval Letter
Piramal Enterprises Ltd / 35455, 52175 / Approval Letter
Piramal Enterprises Ltd / 35456, 52172 / Approval Letter
Piramal Enterprises Ltd / 35457, 52168 / Approval Letter
Rusan Pharma Ltd / 35547, 52079 / Approval Letter
Rusan Pharma Ltd / 35550, 52076 / Approval Letter
Rusan Pharma Ltd / 35546, 52085 / Approval Letter
Rusan Pharma Ltd / 35549, 52087 / Approval Letter
RusanPharma Ltd. / 35548, 52063 / Approval Letter
Sanofi-Synthelabo (India) Ltd / 35716, 52570 / Approval Letter
Sanofi-Synthelabo (India) Ltd / 35715, 52565 / Approval Letter
Sanofi-Synthelabo (India) Ltd / 35714, 52562 / Approval Letter
Sanofi-Synthelabo (India) Ltd / 35713, 52557 / Approval Letter
SentissPharma Pvt. Ltd / 35398, 52044 / Approval Letter
Sitec Labs Pvt Ltd / 35614, 52660 / Approval Letter
Tevapharm India Pvt. Ltd / 35798, 52513 / Approval Letter
Tevapharm India Pvt. Ltd / 35799, 52512 / Approval Letter
Tevapharm India Pvt. Ltd / 35800, 52500 / Approval Letter
Tevapharm India Pvt. Ltd / 35801, 52507 / Approval Letter
Tevapharm India Pvt. Ltd / 35802, 52505 / Approval Letter
Tevapharm India Pvt. Ltd / 35803, 52503 / Approval Letter
Tevapharm India Pvt. Ltd / 35782, 52500 / Approval Letter
Tevapharm India Pvt. Ltd / 35784, 52496 / Approval Letter
Tevapharm India Pvt. Ltd / 35783, 52499 / Approval Letter
Tevapharm India Pvt. Ltd / 35785, 52494 / Approval Letter
Tevapharm India Pvt. Ltd / 35786, 52490 / Approval Letter
Unichem Laboratories Ltd / 35790, 52479 / Approval Letter
Unichem Laboratories Ltd / 35791, 52477 / Approval Letter
Unichem Laboratories Ltd / 35792, 52476 / Approval Letter
Unichem Laboratories Ltd / 35789, 52481 / Approval Letter
Unichem Laboratories Ltd / 35787, 52487 / Approval Letter
Unichem Laboratories Ltd / 35788, 52483 / Approval Letter
V-ensure Pharma Technologies Pvt. Ltd / 35720, 52581 / Approval Letter
V-ensure Pharma Technologies Pvt. Ltd / 35721, 52608 / Approval Letter