LETTERS FOR ISSUE ON11.04.2014

BE NOC FOR EXPORT

S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter
M/s. Athena Drug Delivery Solutions Pvt. Ltd., Dist. Thane, Maharashtra-421 501 / 12147 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 4989 / Approval Letter
M/s. Drug Monitoring Research Institute (P) Ltd., Navi Mumbai-400 701 / 10047 / Amendment Letter
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 5296 / Approval Letter
M/s. Lupin Bioresearch Center, Pune-411 021 / 3876 / Approval Letter
M/s. Manipal Acunova Ltd., Manipal -576104 / 12480 / Approval Letter
M/s. Novel Clinical Research (India) Pvt. Ltd., Karnataka-560 069 / 1546 / Amendment Letter
M/s. RA Chem Pharma Ltd., Balanagar, Hyderabad-500 037 / 7827 / Approval Letter
M/s. Reliance Life Sciences Pvt. Ltd., Navi Mumbai-400 701 / 5238 / Rejection Letter

LVP DIVISION

S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS
01 / M/s Eurolife Healthcare, Uttarakhand / 9534 / Approval
02 / M/s. Parenteral Drugs (I) Ltd., Indore / 7042 / Approval
03 / M/s. Nirma Ltd., Gujarat / 9533 / Approval
04 / M/s. Shree Krishna Keshav, Gujarat / 9312 / Approval
05 / M/s. Parenteral Drugs (I) Ltd., Indore / 7046 / Approval
06 / M/s. Unique Pharmaceuticals Laboratories, Gujarat / 13588 / Approval
07 / M/s. Denis Chem Lab., Gujarat / 5622 / Approval
08 / M/s. Aishwarya Lifesciences, H.P. / 9702 / Approval
09 / M/s. Tablets India, Chennai / 9057 / Approval
10 / M/s. Gland Pharma Ltd., Hyderabad / 13775 / Approval
11 / M/s. Eurolife Healthcare, Uttarakhand / 9536 / Approval

VACCINE DIVISION

S. No. / COMPANY NAME / Dy.No. / STATUS
1 / M/s Sanofi Pasteur India Pvt Ltd / 4489, 43130 / Approval letter& Clarification

BIOLOGICAL DIVISION

S. No. / COMPANY NAME / Dy.No. / STATUS
1 / M/s Haster Biosciences Limited / 4182 / Clarification letter

TEST LICENCES

S. No. / Name of the Company / Diary No. / Type of Letter
Actavis Pharma Development Centre Pvt. Ltd / 9381, 14271 / Approval Letter
Actavis Pharma Development Centre Pvt. Ltd / 9378, 14269 / Approval Letter
Actavis Pharma Development Centre Pvt. Ltd / 9377, 14270 / Approval Letter
Actavis Pharma Development Centre Pvt. Ltd / 9380, 14256 / Approval Letter
Actavis Pharma Development Centre Pvt. Ltd / 9521, 14541 / Approval Letter
Actavis Pharma Development Centre Pvt. Ltd / 9534, 14540 / Approval Letter
Actavis Pharma Development Centre Pvt. Ltd / 9535, 14537 / Approval Letter
Actavis Pharma Development Centre Pvt. Ltd / 9519, 14543 / Approval Letter
Actavis Pharma Development Centre Pvt. Ltd / 9520, 14545 / Approval Letter
Actavis Pharma Development Centre Pvt. Ltd / 9524, 14548 / Approval Letter
Actavis Pharma Development Centre Pvt. Ltd / 9525, 14552 / Approval Letter
Actavis Pharma Development Centre Pvt. Ltd / 9540, 14524 / Approval Letter
Actavis Pharma Development Centre Pvt. Ltd / 9538, 14530 / Approval Letter
Actavis Pharma Development Centre Pvt. Ltd / 9537, 14533 / Approval Letter
Actavis Pharma Development Centre Pvt. Ltd / 9536, 14535 / Approval Letter
Actavis Pharma Development Centre Pvt. Ltd / 9522, 14695 / Approval Letter
Actavis Pharma Development Centre Pvt. Ltd / 9523, 14735 / Approval Letter
Actavis Pharma Development Centre Pvt. Ltd. / 9379, 14257 / Approval Letter
Alembic Pharmaceuticals Ltd / 9626, 14727 / Approval Letter
Alembic Pharmaceuticals Ltd / 9628, 14723 / Approval Letter
Alembic Pharmaceuticals Ltd / 9629, 14719 / Approval Letter
Alembic Pharmaceuticals Ltd / 9630, 14717 / Approval Letter
Alkem Laboratories Ltd / 9351, 14267 / Approval Letter
Alkem Laboratories Ltd / 9350, 14268 / Approval Letter
APL Research Centre / 9359, 14272 / Approval Letter
Apotex Research Pvt Ltd / 9148, 14316 / Approval Letter
Apotex Research Pvt Ltd / 9146, 14324 / Approval Letter
Apotex Research Pvt Ltd / 9147, 14320 / Approval Letter
Apotex Research Pvt Ltd / 9149, 14311 / Approval Letter
Apotex Research Pvt Ltd / 9150, 14308 / Approval Letter
Apotex Research Pvt Ltd / 9151, 14304 / Approval Letter
Apotex Research Pvt. Ltd / 9216, 14291 / Approval Letter
Apotex Research Pvt. Ltd / 9145, 14262 / Approval Letter
Apotex Research Pvt. Ltd / 9144, 14263 / Approval Letter
Apotex Research Pvt. Ltd / 9641, 14992 / Approval Letter
Centaur Pharmaceuticals Pvt. Ltd / 9658, 15036 / Approval Letter
Cipla Ltd / 9315, 14312 / Approval Letter
Cipla Ltd / 9316, 14310 / Approval Letter
Cipla Ltd / 9317, 14309 / Approval Letter
Cipla Ltd / 9318, 14307 / Approval Letter
Cipla Ltd / 9296, 14306 / Approval Letter
Cipla Ltd / 9314, 14313 / Approval Letter
Cipla Ltd / 9313, 14314 / Approval Letter
Cipla Ltd / 9312, 14315 / Approval Letter
Cipla Ltd / 9311, 14317 / Approval Letter
Cipla Ltd / 9310, 14318 / Approval Letter
Cipla Ltd / 9309, 14319 / Approval Letter
Cipla Ltd / 9324, 14328 / Approval Letter
Cipla Ltd / 9325, 14329 / Approval Letter
Cipla Ltd. / 9299, 14233 / Approval Letter
Cipla Ltd. / 9298, 14235 / Approval Letter
Cipla Ltd. / 9300, 14239 / Approval Letter
Cipla Ltd. / 9301, 14241 / Approval Letter
Cipla Ltd. / 9304, 14244 / Approval Letter
Cipla Ltd. / 9302, 14243 / Approval Letter
Cipla Ltd. / 9306, 14274 / Approval Letter
Cipla Ltd. / 9305, 14273 / Approval Letter
Dr. Reddy’s Laboratories Ltd / 9433, 14561 / Approval Letter
Dr. Reddy’s Laboratories Ltd / 9432, 14557 / Approval Letter
Dr. Reddy’s Laboratories Ltd / 9435, 14565 / Approval Letter
Dr. Reddy’s Laboratories Ltd / 9436, 14734 / Approval Letter
Dr. Reddy’s Laboratories Ltd / 9437, 14733 / Approval Letter
Dr. Reddy’s Laboratories Ltd / 9438, 14732 / Approval Letter
Dr. Reddy’s Laboratories Ltd / 9439, 14730 / Approval Letter
Dr. Reddy’s Laboratories Ltd / 9440, 14729 / Approval Letter
Dr. Reddy’s Laboratories Ltd / 9441, 14728 / Approval Letter
Emcure Pharmaceuticals Ltd. / 9662, 14995 / Approval Letter
Epsilon Pharmaceuticals Pvt. Ltd / 9651, 15034 / Approval Letter
Epsilon Pharmaceuticals Pvt. Ltd / 9652, 15032 / Approval Letter
Epsilon Pharmaceuticals Pvt. Ltd / 9653, 15030 / Approval Letter
Epsilon Pharmaceuticals Pvt. Ltd / 9655, 15026 / Approval Letter
Epsilon Pharmaceuticals Pvt. Ltd / 9654, 15027 / Approval Letter
Eugia Pharma Specialities Ltd / 9349, 14265 / Approval Letter
Eugia Pharma Specialities Ltd / 9342, 14266 / Approval Letter
Eugia Pharma Specialities Ltd / 9338, 14330 / Approval Letter
Eugia Pharma Specialities Ltd / 9339, 14332 / Approval Letter
Eugia Pharma Specialities Ltd / 9340, 14334 / Approval Letter
Eugia Pharma Specialities Ltd / 9341, 14228 / Approval Letter
Evonik India Pvt Ltd / 9642, 14990 / Approval Letter
Evonik India Pvt Ltd / 9643, 14987 / Approval Letter
Fresenius Kabi Oncology Ltd / 9089, 14289 / Approval Letter
Getz Pharma Research Pvt. Ltd / 9262, 14305 / Approval Letter
Getz Pharma Research Pvt. Ltd / 9261, 14303 / Approval Letter
Getz Pharma Research Pvt. Ltd / 9260, 14302 / Approval Letter
Getz Pharma Research Pvt. Ltd / 9259, 14301 / Approval Letter
Getz Pharma Research Pvt. Ltd / 9258, 14299 / Approval Letter
Getz Pharma Research Pvt. Ltd / 9257, 14298 / Approval Letter
Indeus Life Sciences Pvt Ltd / 9081, 14287 / Approval Letter
Intas Pharmaceuticals Ltd / 9322, 14325 / Approval Letter
Intas Pharmaceuticals Ltd / 9323, 14326 / Approval Letter
Intas Pharmaceuticals Ltd / 9616, 14596 / Approval Letter
Intas Pharmaceuticals Ltd / 9613, 14600 / Approval Letter
Intas Pharmaceuticals Ltd / 9612, 14606 / Approval Letter
Inventia Healthcare Pvt. Ltd / 9250, 14254 / Approval Letter
Johnson and Johnson Ltd / 9357, 14277 / Approval Letter
Johnson and Johnson Ltd / 9559, 14631 / Approval Letter
Macleods Pharmaceuticals Ltd / 9399, 14292 / Approval Letter
Micro Labs Ltd / 9620, 14585 / Approval Letter
Micro Labs Ltd. / 9622, 14709 / Approval Letter
Micro Labs Ltd. / 9621, 14703 / Approval Letter
MSN Laboratories Ltd / 9664, 15020 / Approval Letter
MSN Laboratories Ltd / 9666, 15021 / Approval Letter
MSN Laboratories Ltd / 9665, 15023 / Approval Letter
MSN Laboratories Ltd / 9663, 15025 / Approval Letter
Mylan Laboratories Ltd / 9211, 14297 / Approval Letter
Mylan Laboratories Ltd / 9213, 14295 / Approval Letter
Mylan Laboratories Ltd / 9212, 14296 / Approval Letter
Mylan Laboratories Ltd / 9222, 14288 / Approval Letter
Mylan Laboratories Ltd / 9223, 14286 / Approval Letter
Mylan Laboratories Ltd / 9224, 14283 / Approval Letter
Mylan Laboratories Ltd / 9225, 14280 / Approval Letter
Mylan Laboratories Ltd / 9226, 14333 / Approval Letter
Mylan Laboratories Ltd / 9210, 14300 / Approval Letter
Nectar Life Sciences Ltd / 9307, 14335 / Approval Letter
Nectar Life Sciences Ltd / 9306, 14336 / Approval Letter
Novartis Healthcare Pvt Ltd / 9400, 14253 / Approval Letter
Novartis Healthcare Pvt Ltd / 9394, 14258 / Approval Letter
Novartis Healthcare Pvt Ltd / 9304, 14337 / Approval Letter
Novartis Healthcare Pvt Ltd / 9305, 14338 / Approval Letter
Novartis Healthcare Pvt Ltd / 9401, 14327 / Approval Letter
Novartis Healthcare Pvt Ltd / 9303, 14322 / Approval Letter
Novartis Healthcare Pvt Ltd / 9302, 14323 / Approval Letter
PolyPeptide Laboratories Pvt Ltd / 9409, 14340 / Approval Letter
PolyPeptide Laboratories Pvt Ltd / 9408, 14339 / Approval Letter
Ranbaxy Laboratories Ltd / 9553, 14686 / Approval Letter
Ranbaxy Laboratories Ltd / 9554, 14683 / Approval Letter
Ranbaxy Laboratories Ltd / 9555, 14680 / Approval Letter
Ranbaxy Laboratories Ltd / 9556, 14670 / Approval Letter
Ranbaxy Laboratories Ltd / 9557, 14666 / Approval Letter
Ranbaxy Laboratories Ltd / 9549, 14654 / Approval Letter
Ranbaxy Laboratories Ltd / 9550, 14646 / Approval Letter
Ranbaxy Laboratories Ltd / 9552, 14638 / Approval Letter
Ranbaxy Laboratories Ltd / 9551, 14641 / Approval Letter
Sai Life Sciences Ltd / 9101, 14284 / Approval Letter
Sai Life Sciences Ltd / 9100, 14282 / Approval Letter
Sai Life Sciences Ltd / 9099, 14281 / Approval Letter
Sanofi-Synthelabo (India) Ltd / 9308, 14321 / Approval Letter
Sanofi-Synthelabo (India) Ltd / 9307, 14276 / Approval Letter
Sentiss Pharma Pvt. Ltd / 9448, 14476 / Approval Letter
Sentiss Pharma Pvt. Ltd / 9447, 14485 / Approval Letter
Sun Pharmaceutical Industries Ltd / 9398, 14255 / Approval Letter
Sun Pharmaceutical Industries Ltd / 9395, 14259 / Approval Letter
Sun Pharmaceutical Industries Ltd / 9396, 14261 / Approval Letter
Sun Pharmaceutical Industries Ltd / 9397, 14260 / Approval Letter
Sun Pharmaceutical Industries Ltd / 9383, 14331 / Approval Letter
Teva India Pvt Ltd / 9102, 14285 / Approval Letter
Teva India Pvt Ltd / 9104, 14279 / Approval Letter
Teva India Pvt Ltd / 9103, 14278 / Approval Letter
Teva India Pvt. Ltd / 9105, 14264 / Approval Letter
Teva India Pvt. Ltd / 9646, 14975 / Approval Letter
Teva India Pvt. Ltd / 9645, 14977 / Approval Letter
Teva India Pvt. Ltd / 9644, 14984 / Approval Letter
Vimta Labs Ltd / 9214, 14294 / Approval Letter
Vimta Labs Ltd / 9215, 14293 / Approval Letter
Watson Pharma Pvt. Ltd / 9483, 14579 / Approval Letter
Watson Pharma Pvt. Ltd / 9482, 14582 / Approval Letter
Watson Pharma Pvt. Ltd / 9481, 14583 / Approval Letter
Watson Pharma Pvt. Ltd / 9484, 14575 / Approval Letter
Watson Pharma Pvt. Ltd / 9470, 14497 / Approval Letter
Watson Pharma Pvt. Ltd / 9480, 14492 / Approval Letter
Watson Pharma Pvt. Ltd / 9471, 14494 / Approval Letter
Watson Pharma Pvt. Ltd / 9477, 14503 / Approval Letter
Watson Pharma Pvt. Ltd / 9478, 14501 / Approval Letter
Watson Pharma Pvt. Ltd / 9479, 14499 / Approval Letter
Watson Pharma Pvt. Ltd / 9476, 14509 / Approval Letter
Watson Pharma Pvt. Ltd / 9475, 14512 / Approval Letter
Watson Pharma Pvt. Ltd / 9474, 14514 / Approval Letter
Watson Pharma Pvt. Ltd / 9473, 14516 / Approval Letter

GLOBAL CLINICAL TRIAL

Sr. No. / Name of Firm / Reference No. / Type of Letter
1. / M/s. PPD / 47802 / Clarification Letter
2. / M/s. Inventiv / 9601 / Clarification Letter
3. / M/s. BMS / 9891 / Clarification Letter