LETTERS FOR ISSUE ON03.07.2014

MEDICAL DEVICE

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Mais India Medical Devices Pvt. Ltd. / FTS-23071 / Letter
The Bureau of Indian Standard, New Delhi. / FTS-36903 / Letter
M/s. Advanced Bionics India Pvt. Ltd. / 21335 / Query Letter

DIAGNOSTIC DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. BiogenuixMedsystems Pvt. Ltd. / 21806 / Query Letter
M/s. Meril Diagnostics Pvt. Ltd. / 21989 / Query Letter
M/s. Roche Diagnostics India Pvt. Ltd. / 15412 / Query Letter
M/s. Star Human Sciences Pvt. Ltd. / 21815 / Query Letter
M/s. Transasia Bio-Medicals Ltd. / 21859 / Query Letter

BE NOC FOR EXPORT

S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter
M/s. APL Research Center, Hyderabad-500 090 / 21785 / Clarification Letter
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 12212 / Clarification Letter
M/s. Synchron Research Services Pvt. Ltd., Ahmedabad-380 054 / 26520 / Clarification Letter

MEDICAL DEVICE

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Lepu Medical Technology (Beijing) Co. Ltd. / 64143 / Approval (F-RC)
M/s. Feron Life Sciences (P) Ltd. / 19009 / Approval (F-IL)
M/s. Spica Medical Equipment’s Pvt. Ltd. / 21099 / Approval (F-IL)
M/s. Exactech India (P) Ltd. / 17797 / Approval Letter
The State Drugs Controller, Haryana (CLAA)
The Deputy Drugs Controller (I), Ghaziabad (CLAA)
(M/s. Hindustan Syringes & Medical Devices Ltd.) / FTS-34630 / Approval Letter
M/s. Clairvoyance Consulting. / 6064 / Query Letter
M/s. Envision Scientific Pvt. Ltd. / 21398 / Query Letter
M/s. Indigo Impex Pvt. Ltd. / 22443 / Query Letter
M/s. Johnson & Johnson Ltd. / 6691 / Query Letter
The Commissioner, Gujarat (CLAA)
The Deputy Drugs Controller (I), Ahmedabad (CLAA)
M/s. Angiplast Pvt. Ltd., Gujarat (CLAA) / FTS-27698 / Letter
The Deputy Drugs Controller (I), Ghaziabad (CLAA)
The State Drugs Controller, Haryana (CLAA)
M/s. Stermied Medical Devices (P) Ltd., Haryana (CLAA) / FTS-33179 / Letter
M/s. Advanced Bionics India Pvt. Ltd. / 21335 / Query Letter

DIAGNOSTIC DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Roche Diagnostics India Pvt. Ltd. / 19239 / Approval (E-RC)
M/s. Roche Diagnostics India Pvt. Ltd. / 19239 / Approval (E-IL)
M/s. Siemens Ltd. / 6730 / Approval (R-RC)
M/s. Siemens Ltd. / 6730 / Approval (R-IL)
M/s. KHC Healthcare India Pvt. Ltd. / 18457 / Approval (IL)
M/s. MP Biomedicals Pvt. Ld. / 18815 / Approval (IL)
M/s. Siemens Ltd. / 20159 / Approval (IL)
M/s. Siemens Ltd. / 20158 / Approval (E-IL)
M/s. Roche Diagnostics India Pvt. Ltd. / 21343 / Approval (TL)
M/s.Bridgeway Medical Systems. / 21250 / Query Letter
M/s. Achira Labs Pvt. Ltd. / FTS-29008 / Letter

FDC DIVISION

S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT
M/s. Wallace Pharmaceuticals Pvt. Ltd., / 41770 / Clarification Letter
M/s. Ravenbhel Healthcare Pvt .Ltd., / 42920 / Clarification Letter
M/s. Agron Remedies Pvt. Ltd., / 35737 / Clarification Letter
M/s. Sanofi-Synthelabo (India) Ltd., / 11147 / Letter
M/s. GKM New Pharma / 42057 / Letter
M/s. Ajanta Pharma Ltd., / 42011 / Clarification Letter
M/s. Intas Pharmaceuticals Ltd., / 44178 / Letter
M/s. Intas Pharmaceuticals Ltd., / 42207 / Clarification Letter
M/s. MDC Pharmaceuticals Pvt. Ltd., / 43489 / Clarification Letter
M/s. MDC Pharmaceuticals Pvt. Ltd., / 43490 / Clarification Letter
M/s. Crescent Therapeutics Ltd., / 42375 / Clarification Letter
M/s. Arius Formulations Pvt. Ltd., / 43422 / Clarification Letter
M/s. Arius Formulations Pvt. Ltd., / 43420 / Clarification Letter
M/s. Arius Formulations Pvt. Ltd., / 43418 / Clarification Letter
M/s. Gurufcure, / 43722 / Clarification Letter
M/s. Gurufcure, / 41946 / Clarification Letter
M/s. Vance & Health Pharmaceuticals Pvt. Ltd., / 44363 / Clarification Letter
M/s. Orbit Lifesciences, / 42930 / Clarification Letter
M/s. Central Drugs &Pharmaceuticals, / 30651 / Clarification Letter
M/s. Tablets (India) Ltd., / 42958 / Clarification Letter
M/s. Akums Drugs & Pharmaceuticals Ltd., / 41418 / Clarification Letter
M/s. Akums Drugs & Pharmaceuticals Ltd., / 42812 / Clarification Letter
M/s. Merck Ltd., / 21874 / Letter
M/s. Symbiotic Drugs & Dibetic Care Pvt. Ltd., / 36673 / Clarification Letter
M/s. Unibiotech Formulations / 43436 / Clarification Letter
M/s. Acron Pharmaceuticals, / 42263 / Clarification Letter
M/s. Sun Pharma Laboratories Ltd., / 18975 / Letter
M/s. Embiotic Laboratories (P) Ltd., / 43796 / Clarification Letter
M/s. Affy Parenterals, / 43598 / Clarification Letter
M/s. Crescent Labs Pvt. Ltd., / 38788 / Letter
M/s. Bayer Pharmaceuticals Pvt. Ltd., / Clarification Letter

VACCINE DIVISION

S. No. / COMPANY NAME / Dy.No. / STATUS
1 / M/s Apac Biotech Pvt, ltd / 60373 / Clarification Letter
2 / M/s Novo Nordisk India Pvt, Ltd / 9618 / Clarification Letter
3 / M/s Life cell International Pvt, ltd / 60107 / Clarification Letter

TEST LICENCES

S. No. / Name of the Company / Diary No. / Type of Letter
Actavis Pharma Development Centre Pvt td / 24629, 36088 / Approval Letter
Actavis Pharma Development Centre Pvt td / 24625, 36041 / Approval Letter
Actavis Pharma Development Centre Pvt td / 24624, 36032 / Approval Letter
Actavis Pharma Development Centre Pvt td / 24626, 36046 / Approval Letter
Actavis Pharma Development Centre Pvt td / 24627, 36051 / Approval Letter
Actavis Pharma Development Centre Pvt td / 24628, 36057 / Approval Letter
AET Laboratories Pvt. Ltd / 24694, 36165 / Approval Letter
AET Laboratories Pvt. Ltd / 24693, 36174 / Approval Letter
AET Laboratories Pvt. Ltd / 24692, 36180 / Approval Letter
AET Laboratories Pvt. Ltd / 24691, 36186 / Approval Letter
AET Laboratories Pvt. Ltd / 24690, 36192 / Approval Letter
Agila Specialties Pvt Ltd / 24436, 36065 / Approval Letter
Agila Specialties Pvt Ltd / 24437, 35974 / Approval Letter
Alkem Laboratories Ltd / 24648, 36096 / Approval Letter
Apotex Research Pvt. Ltd / 24651, 36220 / Approval Letter
Cadila Healthcare Limited / 24299, 35771 / Approval Letter
Cadila Healthcare Limited / 24300, 35893 / Approval Letter
Cadila Healthcare Limited / 24301, 35900 / Approval Letter
Cadila Healthcare Limited / 24302, 35897 / Approval Letter
Cadila Healthcare Limited / 24303, 35901 / Approval Letter
Cadila Healthcare Limited / 24653, 36209 / Approval Letter
Cadila Healthcare Limited / 24652, 36213 / Approval Letter
Cadila Healthcare Ltd / 24140, 35663 / Approval Letter
Cadila Healthcare Ltd / 24143, 35665 / Approval Letter
Emcure Pharmaceuticals Ltd / 24374, 36383 / Approval Letter
Enem Nostrum Remedies Pvt Ltd / 24298, 35783 / Approval Letter
Enem Nostrum Remedies Pvt. Ltd / 24312, 35883 / Approval Letter
Enem Nostrum Remedies Pvt. Ltd / 24317, 35887 / Approval Letter
Getz Pharma Research Pvt Ltd / 21318, 31582, 26792, 39597 / Approval Letter
Gland Pharma Ltd / 24650, 36104 / Approval Letter
Gland Pharma Ltd / 24649, 36101 / Approval Letter
Johnson and Johnson Ltd / 24688, 36080 / Approval Letter
Johnson and Johnson Ltd / 24689, 36073 / Approval Letter
Johnson and Johnson Ltd / 24696, 35987 / Approval Letter
Johnson and Johnson Ltd / 24697, 35994 / Approval Letter
Johnson and Johnson Ltd / 24700, 35999 / Approval Letter
Jubilant Life Sciences Ltd / 24478, 36325 / Approval Letter
Jubilant Life Sciences Ltd / 20827, 27605, 40693 / Approval Letter
Medopharm Pvt Ltd / 24698, 36008 / Approval Letter
Mylan Laboratories Ltd / 24316, 35880 / Approval Letter
Nectar Lifesciences Ltd / 24655, 36293 / Approval Letter
Nectar Lifesciences Ltd / 24654, 36200 / Approval Letter
Onco Therapies Ltd / 12080, 18450, 23596, 35040 / Approval Letter
RA Chem Pharma Ltd / 20242, 30102, 26600, 39355 / Approval Letter
Ranbaxy Laboratories Ltd / 24259, 35913 / Approval Letter
Ranbaxy Laboratories Ltd / 24260, 35788 / Approval Letter
Tevapharm India Private limited / 24673, 36249 / Approval Letter
Tevapharm India Private limited / 24672, 36256 / Approval Letter
Tevapharm India Private limited / 24671, 36259 / Approval Letter
Tevapharm India Private limited / 24670, 36262 / Approval Letter
Tevapharm India Private limited / 24669, 36265 / Approval Letter
Tevapharm India Private limited / 24668, 36267 / Approval Letter
Tevapharm India Private limited / 24681, 36269 / Approval Letter
Tevapharm India Private limited / 24680, 36271 / Approval Letter
Tevapharm India Private limited / 24676, 36283 / Approval Letter
Tevapharm India Pvt Ltd / 24677, 36280 / Approval Letter
Tevapharm India Pvt Ltd / 24675, 36286 / Approval Letter
Tevapharm India Pvt Ltd / 24674, 36290 / Approval Letter
Tevapharm India Pvt Ltd / 24666, 36236 / Approval Letter
Tevapharm India Pvt Ltd / 24667, 36231 / Approval Letter
Tevapharm India Pvt Ltd / 24665, 36244 / Approval Letter
Tevapharm India Pvt Ltd / 24678, 36277 / Approval Letter
Tevapharm India Pvt Ltd / 24679, 36273 / Approval Letter
Torrent Pharmaceuticals Ltd / 24474, 36298 / Approval Letter
Torrent Pharmaceuticals Ltd / 24473, 36303 / Approval Letter
V-ensure Pharma Technologies Pvt Ltd / 24476, 36331 / Approval Letter
V-ensure Pharma Technologies Pvt Ltd / 24477, 36328 / Approval Letter
Watson Pharma Pvt. Ltd / 24347, 35868 / Approval Letter
Watson Pharma Pvt. Ltd / 24348, 35867 / Approval Letter
Watson Pharma Pvt. Ltd / 24349, 35873 / Approval Letter
Watson Pharma Pvt. Ltd / 24350, 35871 / Approval Letter
Watson Pharma Pvt. Ltd / 24351, 35876 / Approval Letter
Watson Pharma Pvt. Ltd / 24396, 36368 / Approval Letter
Watson Pharma Pvt. Ltd / 24395, 36371 / Approval Letter
Watson Pharma Pvt. Ltd / 24398, 36374 / Approval Letter
Watson Pharma Pvt. Ltd / 24397, 36378 / Approval Letter
Wockhardt Ltd / 24376, 36310 / Approval Letter
Wockhardt Ltd / 24375, 36324 / Approval Letter
Wockhardt Ltd / 24377, 36334 / Approval Letter
Intas Pharmaceuticals Ltd / 23671, 35117 / Amendment Letter
Jubilant Life Sciences Ltd / 27604, 40694 / Amendment Letter
Actavis Pharma Development Centre Pvt Ltd / 21934, 32571 / Deficiency Letter
Alkem Laboratories Ltd / 24647 / Deficiency Letter
APL Research Centre / 24146, 35660 / Deficiency Letter
Aristo Pharmaceuticals Pvt Ltd / 23872, 35412 / Deficiency Letter
Cipla Ltd / 23478, 34718, 23479, 34714, 23876, 35349 / Deficiency Letter
Dr. Reddy’s Laboratories Ltd / 22626, 33520 / Deficiency Letter
Dr. Reddy’s Laboratories Ltd / 22629, 33506 / Deficiency Letter
Emcure Pharmaceuticals Ltd / 23591, 35036 / Deficiency Letter
Enem Nostrum Remedies Pvt Ltd / 21983, 32667 / Deficiency Letter
Finoso Pharma Pvt Ltd / 22409, 33063 / Deficiency Letter
Johnson and Johnson Ltd / 23554, 34867 / Deficiency Letter
Jubilant Life Sciences Ltd / 22511, 33216 / Deficiency Letter
Jubilant Life Sciences Ltd / 23311, 34500 / Deficiency Letter
Lupin Ltd / 21965, 32619 / Deficiency Letter
Novartis Healthcare Pvt Ltd / 23541, 34687 / Deficiency Letter
Orbicular Pharmaceutical Technologies Pvt Ltd / 23104, 34140, 23106, 34148 / Deficiency Letter
Ranbaxy Laboratories Ltd / 22177, 32998 / Deficiency Letter
Stabicon Life Sciences Pvt Ltd / 21237, 31729 / Deficiency Letter
Stabicon Life Sciences Pvt Ltd / 21236, 31726 / Deficiency Letter
Unique Pharmaceuticals Laboratories / 22067, 32950 / Deficiency Letter
Vimta Labs Ltd / 22949, 34189 / Deficiency Letter
Vimta Labs Ltd / 22374, 33341 / Deficiency Letter
Wockhardt Ltd / 23326, 34655 / Deficiency Letter
Wockhardt Ltd / 23379, 34869 / Deficiency Letter