Letters for Issue On19.05.2014

LETTERS FOR ISSUE ON19.05.2014

MEDICAL DEVICE

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. India Medtronic Pvt. Ltd. / 9329 / Approval (F-RC)
M/s. Sandor Medicaids Pvt. Ltd. / 11512 / Approval (F-RC)
M/s. Johnson & Johnson Ltd. / 65370 / Approval (E-RC)
M/s. Boston Scientific India Pvt. Ltd. / 44610 / Approval (R-E-RC)
M/s. MN Solutions. / 10770 / Approval (R-E-RC)
M/s. India Medtronic Pvt. Ltd. / 9329 / Approval (F-IL)
M/s. Meril Life Sciences Pvt. Ltd. / 9982 / Approval (F-IL)
M/s. Boston Scientific India Pvt. Ltd. / 44610 / Approval (R-E-IL)
M/s. Biotech Vision Care Pvt. Ltd. / 58896 / Approval (F-RC)
M/s. Lensai Ophthalmic Pvt. Ltd. / 11823 / Approval (R-IL)

DIAGNOSTIC DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Bio-Rad Laboratories (India) Pvt. Ltd. / 14795 / Approval (IL)
M/s. Bio-Rad Laboratories (India) Pvt. Ltd. / 14028 / Approval (IL)
M/s. Bio-Rad Laboratories (India) Pvt. Ltd. / 9253 / Approval (IL)
M/s. Compact Diagnostics India (P) Ltd. / 11857 / Approval (IL)
M/s. Immunoshop India Pvt. Ltd. / 12153 / Approval (IL)
M/s. Roche Diagnostics India Pvt. Ltd. / 111879 / Approval (TL)
M/s. Compact Diagnostics India (P) Ltd. / 11857 / Query Letter

TEST LICENCES

S. No. / Name of the Company / Diary No. / Type of Letter
AET Laboratories Ltd / 15380, 23052 / Approval Letter
AET Laboratories Pvt. Ltd / 15377,23066 / Approval Letter
AET Laboratories Pvt. Ltd / 15378, 23060 / Approval Letter
AET Laboratories Pvt. Ltd / 15379, 23056 / Approval Letter
Aizant Drug Research Solutions Pvt. Ltd / 15163, 23136 / Approval Letter
Aizant Drug Research Solutions Pvt. Ltd / 15164, 23129 / Approval Letter
Aizant Drug Research Solutions Pvt. Ltd / 15165, 23128 / Approval Letter
Aizant Drug Research Solutions Pvt. Ltd / 15162, 23137 / Approval Letter
Ajanta Pharma Ltd / 15161, 23116 / Approval Letter
Cadila Healthcare Limited / 15325, 22880 / Approval Letter
Cipla Ltd / 15269, 22950 / Approval Letter
Cipla Ltd / 15270, 22949 / Approval Letter
Cipla Ltd / 15271, 22947 / Approval Letter
Cipla Ltd / 15272, 22943 / Approval Letter
Cipla Ltd / 15273, 22911 / Approval Letter
Cipla Ltd / 15274, 22913 / Approval Letter
Cipla Ltd / 15276, 22927 / Approval Letter
Cipla Ltd / 15277,22933 / Approval Letter
Cipla Ltd / 15278, 22934 / Approval Letter
Cipla Ltd / 15292, 23200 / Approval Letter
Cipla Ltd / 15294, 23188 / Approval Letter
Cipla Ltd / 15295, 23186 / Approval Letter
Cipla Ltd / 15296, 23185 / Approval Letter
Cipla Ltd / 15297, 23181 / Approval Letter
Cipla Ltd / 15298, 23160 / Approval Letter
Cipla Ltd / 15313, 23159 / Approval Letter
Cipla Ltd / 15314, 22940 / Approval Letter
Cipla Ltd / 15275, 22924 / Approval Letter
Cipla Ltd / 15315, 22937 / Approval Letter
Cipla Ltd / 15316, 22907 / Approval Letter
Emcure Pharmaceuticals Ltd / 15337, 23091 / Approval Letter
Emcure Pharmaceuticals Ltd / 15338, 23090 / Approval Letter
Emcure Pharmaceuticals Ltd / 15339, 23087 / Approval Letter
Emcure Pharmaceuticals Ltd / 15342, 23073 / Approval Letter
Emcure Pharmaceuticals Ltd / 15343, 23071 / Approval Letter
Emcure Pharmaceuticals Ltd / 15344, 23080 / Approval Letter
Emcure Pharmaceuticals Ltd / 15347, 23085 / Approval Letter
Eugia Pharma Specialities Ltd / 15189, 23142 / Approval Letter
Eugia Pharma Specialities Ltd / 15190, 23141 / Approval Letter
FTF Pharma Pvt. Ltd. / 15332, 23042 / Approval Letter
Fusion Scientific Laboratories Pvt Ltd / 15254, 23172 / Approval Letter
Glenmark Generics Ltd / 15247, 23132 / Approval Letter
Glenmark Generics Ltd / 15248, 23131 / Approval Letter
Glenmark Generics Ltd / 15250, 23158 / Approval Letter
Glenmark Generics Ltd / 15252, 23124 / Approval Letter
Glenmark Pharmaceuticals Ltd / 15249, 23130 / Approval Letter
Glenmark Pharmaceuticals Ltd / 15251, 23126 / Approval Letter
Intas Pharmaceuticals Ltd / 15172, 23204 / Approval Letter
Intas Pharmaceuticals Ltd / 15173, 23203 / Approval Letter
Intas Pharmaceuticals Ltd / 15174, 23201 / Approval Letter
Intas Pharmaceuticals Ltd / 15175, 23201 / Approval Letter
Intas Pharmaceuticals Ltd / 15176, 23144 / Approval Letter
Intas Pharmaceuticals Ltd / 15177, 23143 / Approval Letter
Lupin Ltd. / 15207,22966 / Approval Letter
Ranbaxy Laboratories Ltd / 15191, 23140 / Approval Letter
Ranbaxy Laboratories Ltd / 15192, 23139 / Approval Letter
Ranbaxy Laboratories Ltd / 15193, 23138 / Approval Letter
Ranbaxy Laboratories Ltd / 15194, 23122 / Approval Letter
Ranbaxy Laboratories Ltd / 15257, 23169 / Approval Letter
Ranbaxy Laboratories Ltd / 15258, 23152 / Approval Letter
Ranbaxy Laboratories Ltd / 15259, 23151 / Approval Letter
Ranbaxy Laboratories Ltd / 15260, 23149 / Approval Letter
Sai Life Sciences Ltd / 15255, 23146 / Approval Letter
Sai Life Sciences Ltd / 15340, 23045 / Approval Letter
Sun Pharmaceutical Industries Ltd / 15256, 23170 / Approval Letter
Unichem Laboratories Ltd / 15375, 23024 / Approval Letter
Unichem Laboratories Ltd / 15376, 23020 / Approval Letter
Unichem Laboratories Ltd / 15380, 23052 / Approval Letter
Unichem Laboratories Ltd / 15390, 22997 / Approval Letter
Unichem Laboratories Ltd / 15391, 22993 / Approval Letter
Unichem Laboratories Ltd / 15392, 22989 / Approval Letter
Unichem Laboratories Ltd / 15393, 22983 / Approval Letter
Unichem Laboratories Ltd / 15394, 22980 / Approval Letter
Unichem Laboratories Ltd / 15395, 23012 / Approval Letter
Unichem Laboratories Ltd / 15396, 23014 / Approval 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 / 12481 / Approval Letter
M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 11088 / Approval Letter
M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 11399 / Approval Letter
M/s. Alkem Laboratories Ltd, Dist: Raigad -410208 / 12757 / Approval Letter
M/s. Alkem Laboratories Ltd, Raigad -410208 / 13572 / Approval Letter
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 11815 / Approval Letter
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 13789 / Approval Letter
M/s. APL Research Centre, Hyderabad-500 072 / 11071 / Amendment Letter
M/s. APL Research Centre, Hyderabad-500 090 / 63915 / Approval Letter
M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 13868 / Approval Letter
M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 13821 / Approval Letter
M/s. Axis Clinical Ltd., Hyderabad-500 049 / 9668 / Amendment Letter
M/s. Axis Clinical Ltd., Hyderabad-500 049 / 15763 / Approval Letter
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 13922 / Approval Letter
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 12251 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 13299 / Rejection Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 13306 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 12407 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 14324 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 14329 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 14330 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 14242 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 57596 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 13307 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 11750 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 14327 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 14313 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 53049 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 13526 / Approval Letter
M/s. Dr. Reddy's Laboratories Ltd., Hyderabad-500 034 / 13463 / Rejection Letter
M/s. GVK Biosciences Pvt. Ltd., Hyderabad-500 038 / 16688 / Approval Letter
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 56472 / Amendment Letter
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 12884 / Approval Letter
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 12074 / Approval Letter
M/s. Lupin Bioresearch Center, Pune-411 021 / 10832 / Amendment Letter
M/s. Lupin Bioresearch Center, Pune-411 021 / 12141 / Approval Letter
M/s. Lupin Bioresearch Center, Pune-411 021 / 13904 / Approval Letter
M/s. Lupin Bioresearch Center, Pune-411 021 / 12840 / Approval Letter
M/s. Lupin Bioresearch Center, Pune-411 021 / 12841 / Approval Letter
M/s. Manipal Acunova KH Clinical Research Centre, Manipal -576104 / 11059 / Approval Letter
M/s. RA Chem Pharma Ltd., Balanagar, Hyderabad-500 037 / 11662 / Approval Letter
M/s. RA Chem Pharma Ltd., Balanagar, Hyderabad-500 037 / 13233 / Approval Letter
M/s. Ranbaxy Laboratories Ltd., New Delhi-110 019 / 64062 / Approval Letter
M/s. Raptim Research Ltd., Navi Mumbai-400 701 / 8364 / Approval Letter
M/s. Synchron Research Services Pvt. Ltd., Ahmedabad-380 054 / 19100 / Amendment Letter
M/s. Torrent Pharmaceuticals Ltd. (Research Centre), Gujarat / 10558 / Approval Letter
M/s. Torrent Pharmaceuticals Ltd. (Research Centre), Gujarat / 12366 / Approval Letter
M/s. Torrent Pharmaceuticals Ltd. (Research Centre), Gujarat / 12365 / Approval Letter
M/s. Torrent Pharmaceuticals Ltd. (Research Centre), Gujarat / 714 / Approval Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 12447 / Approval Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 14250 / Approval Letter
M/s. Vimta Labs Ltd., Hyderabad-500051 / 11119 / Approval Letter
M/s. Wockhardt Limited, Aurangabad-431 006 / 10914 / Approval 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 / 6546 / Test Licence
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 13787 / Test Licence
M/s. Axis Clinical Ltd., Hyderabad-500 049 / 12855 / Test Licence
M/s. Axis Clinical Ltd., Hyderabad-500 049 / 13614 / Test Licence
M/s. Axis Clinical Ltd., Hyderabad-500 049 / 15073 / Test Licence
M/s. Axis Clinical Ltd., Hyderabad-500 049 / 15074 / Test Licence
M/s. Axis Clinical Ltd., Hyderabad-500 049 / 15072 / Test Licence
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 13917 / Test Licence
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 14243 / Test Licence
M/s. Clinsync Clinical Research Pvt. Ltd., Hyderabad-501 505 / 9960 / Test Licence
M/s. Drug Monitoring Research Institute (P) Ltd., Navi Mumbai-400 701 / 17254 / Test Licence
M/s. Fortis Clinical Research Ltd., Faridabad-121002 / 8520 / Test Licence
M/s. Inventia Healthcare Pvt. Ltd., Thane-400 604 / 12179 / Test Licence
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 13357 / Test Licence
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 12482 / Test Licence
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 12483 / Test Licence
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 18050 / Test Licence
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 18033 / Test Licence
M/s. Lupin Bioresearch Center, Pune-411 021 / 11392 / Test Licence
M/s. Lupin Bioresearch Center, Pune-411 021 / 12842 / Test Licence
M/s. Micro Therapeutic Research Labs Pvt. Ltd., Chennai-600 059 / 11935 / Test Licence
M/s. Micro Therapeutic Research Labs Pvt. Ltd., Coimbatore-641029 Tamil Nadu / 11412 / Test Licence
M/s. Micro Therapeutic Research Labs Pvt. Ltd., Coimbatore-641029 Tamil Nadu / 12352 / Test Licence
M/s. Om Sai Clinical Research Pvt. Ltd., Sangli-416 416, Maharsahtra / 19380 / Test Licence
M/s. Om Sai Clinical Research Pvt. Ltd., Sangli-416 416, Maharsahtra / 19378 / Test Licence
M/s. Om Sai Clinical Research Pvt. Ltd., Sangli-416 416, Maharsahtra / 19379 / Test Licence
M/s. Semler Research Center Pvt. Ltd., Bangalore-560078 / 12148 / Test Licence
M/s. Semler Research Center Pvt. Ltd., Bangalore-560078 / 11289 / Test Licence

VACCINE DIVISION

S. No. / COMPANY NAME / Dy.No. / STATUS
1 / M/s Cadila Healthcare Ltd / 16417 / Approval letter
2 / M/s Intas Pharmaceuticals Ltd / Clarification Letter
3 / M/s Johnson & Johnson Ltd / 6439 / Clarification Letter
4 / M/s Virchow Biotech Pvt, Ltd / 16531 (fts no) / Approval letter
5 / M/s Biocon Ltd / Approval letter
6 / M/s Globion India Pvt, Ltd / 8206 / Approval letter
7 / M/s Intervet India Pvt, Ltd / 6075, 6068, 12250 / Approval letter

MEDICAL DEVICE

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. B. Braun Medical (India) Pvt. Ltd. / 64459 / Query Letter
M/s. Clairvoyance Consulting. / 3854 / Query Letter
M/s. VSY Ophthalmic India Pvt. Ltd. / 62363 / Query Letter
M/s. Zimmer India Pvt. Ltd. / 64254 / Query Letter

REGISTRATION

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
VITA PHARMA AGENCIES / 11146 / APPROVAL LETTER
DOVE PHARMACEUTICALS / 10703 / APPROVAL LETTER
NOVARTIS HELATHCARE PVT. LTD. / 20127 / APPROVAL LETTER
VITA PHARMA AGENCIES / 17518 / CLARIFICATION LETTER

SHELF LIFE

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
STRIDES ARCOLAB LTD. / 9293 / CLARIFICATION LETTER
LINCOLN PHARMACEUTICALS LTD. / 7251 / CLARIFICATION LETTER
INFUGEN PHARMA PVT. LTD. / 9294 / CLARIFICATION LETTER

NEW DRUG

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
M/s. National Institute of Cholera / - / Letter
M/s. Centaur Pharmaceuticals / - / Letter
M/s. Issar Pharma / - / Letter
M/s. Glenmark / - / Letter (2)
M/s. Ranbaxy / - / Letter
M/s. Intas / - / Letter
M/s. Laila Pharma / - / Letter
M/s. Dr. Reddy Labs. / - / Letter
M/s. Cadila Healthcare / - / Letter
M/s. MSN / - / Approval Letter
M/s. Precise / - / Clarification Letter
M/s. Supriya LifeSciences / - / Clarification Letter
Dr. Sheela Daniel, SIHR & LC / - / Clarification Letter
Dr. Sheffali Gulati / - / Clarification Letter
M/s. Roche Products / - / Clarification Letter
M/s. Aizant Drug / - / Clarification Letter
M/s. DNDi / - / Clarification Letter
M/s. Sai Chelation Foundation / - / Clarification Letter