Letters for Issue On20.06.2014
LETTERS FOR ISSUE ON20.06.2014
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. Biogen Idec / - / NDAC Follow-up letter
2. / M/s. Novartis / 13384/17840 / Change in PI Approval
3. / M/s. Chiltern / 21481 / Amendment in CT NOC Approval
4. / M/s. Novotech / 20154 / Export NOC Approval
5. / M/s. Quintiles / 51053 / PA Approval
6. / M/s. Pfizer / NDAC Follow-up letter
7. / M/s. Maya Clinicals / 23216 / Clarification letter
8. / M/s. ICON / 54899 / Clarification Letter
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letterM/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 17441 / Approval Letter
M/s. Agila Specialties Pvt. Ltd., Bangaluru-560 076 / 19862 / Clarification Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 18867 / Approval Letter
M/s. Famy Care Ltd., Mumbai-400 001 / 20761 / Clarification Letter
M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 19534 / Approval Letter
M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 19533 / Approval Letter
M/s. Inventia Healthcare Pvt. Ltd., Dist. Thane-421 506 / 19527 / Approval Letter
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 12351 / Additional Study Centre
M/s. Lotus Labs Pvt. Ltd., Chennai-600 004 / 21229 / Approval Letter
M/s. Micro Therapeutic Research Labs Pvt. Ltd., Coimbatore-641029 / 13023 / Amendment Letter
M/s. Quest Life Sciences (P) Ltd., Chennai-600045 / 20862 / Approval Letter
M/s. Semler Research Center Pvt. Ltd., Bangalore-560078 / 14953 / Clarification Letter
M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 16636 / Clarification Letter
M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 19014 / Approval Letter
M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 19019 / Approval Letter
M/s. Synchron Research Services Pvt. Ltd., Ahmedabad-380 054 / 18516 / Amendment Letter
M/s. Unichem Laboratories Ltd., Mumbai-400 102 / 48911 / Approval Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 22325 / Approval Letter
M/s. Vimta Labs Ltd., Hyderabad-500051 / 20234 / Approval Letter
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400 614 / 19460 / Clarification Letter
M/s. Wockhardt Limited, Aurangabad-431 006 / 60283 / Approval Letter
ONLY TEST LICENCE FOR BE
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letterM/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 19819 / Test Licence
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 18868 / Test Licence
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 17711 / Test Licence
M/s. Emcure Pharmaceuticals Limited, Pune-411 026 / 20255 / Test Licence
M/s. GVK Biosciences Pvt. Ltd., Hyderabad-500 038 / 23030 / Test Licence
M/s. Kusum Healthcare Pvt. Ltd., New Delhi-110 020 / 25433 / Test Licence
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 13699 / Test Licence
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 034 / 20640 / Test Licence
M/s. Om Sai Clinical Research Pvt. Ltd., Sangli-416 416, Maharsahtra / 24884 / Test Licence
M/s. Vimta Labs Ltd., Hyderabad-500051 / 19955 / Test Licence
M/s. Watson Pharma Private Ltd., Navi Mumbai-400 614 / 18446 / Test Licence
M/s. Watson Pharma Pvt Ltd ., Navi Mumbai-400614 / 19949 / Test Licence
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. Biogen Idec / 7521/17358 / Clarification Letter
2. / M/s. Quintiles / 4604 / Clarification Letter
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. Nutri Synapzz Therapeutix Private Limited. / 20628 / Clarification Letter
M/s. White Pharmaceuticals. / 20861 / Clarification Letter
M/s. Mais India Medical Devices Pvt. Ltd. (CLAA)
The State Drugs Controller, Haryana (CLAA) / 16022 / Query Letter
TEST LICENCES
S. No. / Name of the Company / Diary No. / Type of LetterActavis Pharma Development Centre Pvt. Ltd / 21465, 32013 / Approval Letter
Actavis Pharma Development Centre Pvt. Ltd / 21466, 32018 / Approval Letter
Actavis Pharma Development Centre Pvt. Ltd / 21467, 32023 / Approval Letter
Alembic Pharmaceuticals Ltd / 21521, 31933 / Approval Letter
APL Research Centre / 21336, 31773 / Approval Letter
Cipla Ltd / 21657, 32286 / Approval Letter
Cipla Ltd / 21658, 32282 / Approval Letter
Cipla Ltd / 21659, 32285 / Approval Letter
Cipla Ltd / 21660, 32279 / Approval Letter
Cipla Ltd / 21661, 32277 / Approval Letter
Cipla Ltd / 21662, 32328 / Approval Letter
Fresenius Kabi Oncology Ltd / 16262, 24265, 23360, 34885 / Approval Letter
Getz Pharma Research Pvt. Ltd / 21582, 32264 / Approval Letter
Getz Pharma Research Pvt. Ltd / 21583, 32266 / Approval Letter
Getz Pharma Research Pvt. Ltd / 21584, 32213 / Approval Letter
Getz Pharma Research Pvt. Ltd / 21585, 32217 / Approval Letter
Getz Pharma Research Pvt. Ltd / 21587, 32258 / Approval Letter
Glenmark Pharmaceuticals Ltd / 21533, 31959 / Approval Letter
Glenmark Pharmaceuticals Ltd / 21534, 31965 / Approval Letter
Glenmark Pharmaceuticals Ltd / 21535, 31970 / Approval Letter
Glenmark Pharmaceuticals Ltd / 21536, 31973 / Approval Letter
Intas Pharmaceuticals Ltd / 21593, 32273 / Approval Letter
Intas Pharmaceuticals Ltd / 21594, 32272 / Approval Letter
Ipca Laboratories Limited / 21471, 32040 / Approval Letter
Ipca Laboratories Limited / 21487, 31900 / Approval Letter
Ipca Laboratories Limited / 21488, 31905 / Approval Letter
Ipca Laboratories Limited / 21489, 31909 / Approval Letter
Ipca Laboratories Limited / 21490, 31916 / Approval Letter
Ipca Laboratories Limited / 21491, 31920 / Approval Letter
Ipca Laboratories Limited / 21492, 31927 / Approval Letter
Lupin Ltd / 16110, 24119, 24096, 35600 / Approval Letter
Mylan Laboratories Ltd / 21572, 32227 / Approval Letter
Novartis Healthcare Pvt Ltd / 8644, 13075, 20373, 30575, 22872, 33751 / Approval Letter
Novartis Healthcare Pvt Ltd / 13708, 21391, 22873, 33932 / Approval Letter
Novartis Healthcare Pvt Ltd / 13676, 21166, 22873, 33932 / Approval Letter
Novartis Healthcare Pvt Ltd / 13709, 21388, 22873, 33932 / Approval Letter
Novartis Healthcare Pvt Ltd / 13679, 21170, 22873, 33932 / Approval Letter
Pfizer Products India Pct Ltd / 9647, 14980, 15209, 22959 / Approval Letter
Pfizer Products India Pct Ltd / 9648, 14956, 15210, 22955 / Approval Letter
RA Chem Pharma Ltd / 12404, 19243, 20243 / Approval Letter
Ranbaxy Laboratories Ltd / 21612, 32289 / Approval Letter
Ranbaxy Laboratories Ltd / 12329, 18670, 22317, 33307 / Approval Letter
Reliance Life Sciences Pvt Ltd / 16079, 24173, 20334, 36488 / Approval Letter
Roche Products (India) Pvt Ltd / 17055, 25172, 19878, 29791, 24620, 36015 / Approval Letter
Sequent Research Ltd / 21422, 32059 / Approval Letter
Sequent Research Ltd / 21423, 32069 / Approval Letter
Shalina Laboratories Pvt Ltd / 21524, 31943 / Approval Letter
Shalina Laboratories Pvt Ltd / 21525, 31950 / Approval Letter
Shasun Pharmaceuticals Limited / 21573, 32237 / Approval Letter
Shasun Pharmaceuticals Limited / 21574, 32249 / Approval Letter
Stabicon Life Sciences Pvt Ltd / 21233, 31858 / Approval Letter
Stabicon Life Sciences Pvt Ltd / 21234, 31860 / Approval Letter
Sun Pharma Advanced Research Company Ltd / 21591, 32274 / Approval Letter
Sun Pharmaceutical Industries Ltd / 21589, 32255 / Approval Letter
Unichem Laboratories Ltd / 21486, 32034 / Approval Letter
United States Pharmacopeia-India (P) Ltd / 21436, 32120 / Approval Letter
United States Pharmacopeia-India (P) Ltd / 21437, 32118 / Approval Letter
United States Pharmacopeia-India (P) Ltd / 21438, 32117 / Approval Letter
United States Pharmacopeia-India (P) Ltd / 21439, 32116 / Approval Letter
United States Pharmacopeia-India (P) Ltd / 21459, 32112 / Approval Letter
United States Pharmacopeia-India (P) Ltd / 21460, 32107 / Approval Letter
United States Pharmacopeia-India (P) Ltd / 21461, 32121 / Approval Letter
V-ensure Pharma Technologies Pvt. Ltd / 21609, 32268 / Approval Letter
Watson Pharma Pvt. Ltd / 21470, 32028 / Approval Letter
Wintac Ltd / 14436, 21919, 21419, 32063 / Approval Letter
APL Research Centre / 18703, 27933 / Deficiency Letter
Cipla Ltd / 20060, 30326 / Deficiency Letter
Getz Pharma Research Pvt Ltd / 21318, 31582 / Deficiency Letter
Ipca Laboratories Ltd / 20623, 30732, 20626, 30889, 20627, 30886 / Deficiency Letter
Jubilant Life Sciences Ltd / 20827, 31034 / Deficiency Letter
Modi Mundipharma Pvt Ltd / 21424, 32122 / Deficiency Letter
RA Chem Pharma Ltd / 20242, 30102 / Deficiency Letter
Sanofi-Synthelabo (India) Ltd / 20709, 31031, 20710, 31027, 20712, 30966, 20713, 30962, 20714, 30654, 20716, 30657, 20930, 31168, 20942, 31181, 20943, 31308, 20944, 31306 / Deficiency Letter
Shilpa Medicare Ltd / 17182, 25478 / Deficiency Letter
Stabicon Life Sciences Pvt Ltd / 21235, 31862, 21238, 31732, 21238-A, 31729, / Deficiency Letter
Stabicon Life Sciences Pvt Ltd / 21095, 31723 / Deficiency Letter
Vimta Labs Ltd / 20986, 31082 / Deficiency Letter