LETTERS FOR ISSUE ON05.05.2014
IMPORT
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTERAlembic Pharmaceuticals Limited (Formulation Division) / 13497 / Approval Letter
Ruskin Chemipharm / 13502 / Approval Letter
Ipca Laboratories Ltd. / 13385 / Approval Letter
Ipca Laboratories Ltd. / 13386 / Approval Letter
Gufic Biosciences Limited / 13405 / Approval Letter
K.Sevantilal & Co. / 13496 / Approval Letter
Remidex Pharma Private Limited / 13762 / Approval Letter
Sanofi India Ltd. / 13725 / Approval Letter
Gland Pharma Limited / 13818 / Approval Letter
Nestor Pharmaceuticals Ltd. / 13697 / Approval Letter
Lalchand Bhimraj, / 13773 / Approval Letter
Rajasthan Antibiotics Ltd. / 13794 / Approval Letter
Unimed Technologies Ltd. / 13792 / Approval Letter
Astrazeneca Pharma India Ltd. / 13777 / Approval Letter
Astrazeneca Pharma India Ltd. / 13778 / Approval Letter
Dove Pharmaceuticals / 14138 / Amended Letter
REGISTRATION
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTERRUSKIN CHEMI PHARM / 63791 / Approval Letter
MAX NEEMAN MEDICAL INTERNATIONAL / 15109 / AMENDED LETTER
ALLIED PHARMA SOLUTIONS / 10236 / AMENDED LETTER
BHARAT SERUMS & VACCINES LTD. / 39778 / CLARIFICATION LETTER
UNICHEMIE INTERNATIONAL / 64716 / CLARIFICATION LETTER
VACCINE DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s Pfizer Products India Pvt, Ltd / 65341, 211 / Approval Letter
2 / M/s Serum Institute of India Ltd / 15386 / Approval Letter
3 / M/s PanEra Biotech Pvt Ltd / 1742, 1743, 1741 / Clarification Letter
4 / M/s Indian Immunlogicals Ltd / 12918, 14103 / Clarification Letter
5 / M/s PlasmaGen Bioscience Pvt, Limited / Clarification letter
BIOLOGICAL DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s Green Signal Biopharma Pvt, Ltd / 37348 (fts no) / Approval Letter
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. St. John’s national Academy / 51839/54550 / Change in PI Approval
2. / M/s. Clinatha / 8373 / CT NOC Approval
3. / M/s. Nexus / - / 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 / 9669 / Approval Letter
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 9827 / Approval Letter
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 10156 / Approval Letter
M/s. Cadila Healthcare Ltd., Ahmedabad-380015 / 9884 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 7843 / Clarification Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 8879 / Clarification Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 9455 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 15837 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 9453 / Approval Letter
M/s. Clinsync Clinical Research Pvt. Ltd., Hyderabad-501 505 / 7199 / Rejection Letter
M/s. Ethics Bio Lab Pvt. Ltd., Pallikaranai, Chennai-600 100 / 12380 / Approval Letter
M/s. Ethics Bio Lab Pvt. Ltd., Pallikaranai, Chennai-600 100 / 12379 / Approval Letter
M/s. Famy Care Ltd., Mumbai-400 001 / 4948 / Additional Study Centre
M/s. GVK Biosciences Pvt. Ltd., Hyderabad-500 038 / 9386 / Approval Letter
M/s. Jubilant Life Sciences Ltd., Noida-201 301, UP / 7829 / Clarification Letter
M/s. Lupin Bioresearch Center, Pune-411 021 / 9776 / Clarification Letter
M/s. Lupin Bioresearch Center, Pune-411 021 / 10216 / Approval Letter
M/s. Lupin Bioresearch Center, Pune-411 021 / 9778 / Approval Letter
M/s. Manipal Acunova Ltd., Mangalore-575 001 / 11139 / Approval Letter
M/s. Manipal Acunova Ltd., Mangalore-575 001 / 11138 / Approval Letter
M/s. QPS Bioserve India Pvt. Ltd., Hyderabad – 500 037 / 11184 / Approval Letter
M/s. QPS Bioserve India Pvt. Ltd., Hyderabad – 500 037 / 13543 / Approval Letter
M/s. Raptim Research Ltd., Navi Mumbai-400 701 / 13406 / Approval Letter
M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 65149 / Amendment Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 10295 / Approval Letter
M/s. Windlas Healthcare Pvt. Ltd., Dehradun-248 110 / 15866 / 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 / 10336 / Test Licence
M/s. Hetero Labs Ltd., Hyderabad-500 018 / 9388 / Test Licence
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 9677 / Test Licence
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 6699 / Test Licence
M/s. Piramal Clinical Research, Hydearbad-500 013 / 9865 / Test Licence
M/s. QPS Bioserve India Pvt. Ltd., Hyderabad – 500 037 / 12597 / Test Licence