LETTERS FOR ISSUE ON12.12.2014
LVP DIVISION
S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS01 / M/s. Abaris Healthcare Pvt. Ltd., Gujarat / 71410 / Approval
02 / M/s. Kusum Healthcare Pvt. Ltd., C/o. M/s. Amanta Healthcare Ltd., Gujarat / 69619, 63230 / Approval
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENTM/s. Akums Drugs & Pharmaceuticals Ltd., / 39875 / Letter
M/s. Laborate Pharmaceutical India Limited, / 43189 / Letter
M/s. GKM New Pharma / 50526 / Letter
M/s. BHC Lab Pvt. Ltd., / 48659 / Letter
M/s. Alcon Laboratories India Pvt. Ltd., / 27913 / Letter
M/s. Elan Pharma (India) Pvt. Ltd., / 43524 / Letter
IMPORT REGISTRATION
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTERMERCK SPECIALTIES PVT. LTD / 32684,32683 / 02 CLARIFICATION LETTER
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTERM/S Themis Medicare Ltd., / 41107 / 60452 / Query Letter
Medical Device
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. Lifecare Devices Pvt. Ltd. / 40012 / Approval (F-RC)
M/s. Meril Healthcare Pvt. Ltd. / FTS-16888 / Approval (F-RC)
M/s. Abbott Healthcare Pvt. Ltd. / 31640 / Approval (E-RC)
M/s. Abbott Healthcare Pvt. Ltd. / 31640 / Approval (E-IL)
M/s. B. L. Lifescience Pvt. Ltd. / 40625 / Approval (R-RC)
M/s. Biotronik Medical Devices India Pvt. Ltd. / 43800 / Approval Letter
M/s. Boston Scientific India Pvt. Ltd. / 38548 / Letter
M/s. Biomet Orthopaedic India Pvt. Ltd. / 39030 / Query Letter
M/s. Boston Scientific India Pvt. Ltd. / 20608 / Query Letter
M/s. NutriSynapzzTherapeutix Pvt. Ltd. / 43817 / Letter
M/s. Fortis Escorts Heart Institute & Research Centre. / 35054 / Query Letter
M/s. Smith & Nephew Healthcare Pvt. Ltd. / 33074 / Query Letter
The State Drugs Controller, Haryana (CLAA)
The Deputy Drugs Controller (I), Ghaziabad (CLAA)
(M/s. Bio-Med Healthcare Products Pvt. Ltd.) / FTS-67903 / Approval Letter
The State Drugs Controller, Haryana (CLAA)
The Deputy Drugs Controller (I), Ghaziabad (CLAA)
(M/s. Bio-Med Healthcare Products Pvt. Ltd.) / FTS-59053 / Approval Letter
(Global Clinical Trial)
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. Eli Lilly / - / Clarification Letter
2. / M/s. PPD / 42740 / Change in PI Approval
3. / M/s. Novartis / 462361/14/11/14 / Clarification Letter
4. / M/d. Pharmanet / 44628 / Change in PI Approval
NEW DRUG
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTERDr. Rajni Kaul / - / Letter
M/s. MSN Laboratories Ltd / - / Approval Letter (2)
M/s. Cadila Healthcare Ltd / - / Approval Letter (2)
Vaccine Division
S. No. / COMPANY NAME / Dy. No. / STATUS4 / M/s Reliance Life Sciences Pvt, ltd / 37448, 43754, , 10002, 10003, , 10498, 69618 (fts no) / Approval & Clarification Letter
6 / M/s Venkateshwara Hatcheries Pvt, ltd / 56504 (fts no) / Approval Letter
7 / M/s Bharat Serum and vaccine ltd / 52741 (fts no) / Short supply of Anti Snake venom
8 / M/s Haffkine Biopharmaceuticals corporation / 52741 (fts no) / Short supply of Anti Snake venom
9 / M/s Premium serum and vaccine Pvt, Ltd / 52741 (fts no) / Short supply of Anti Snake venom
10 / M/s Vins Bioproducts ltd / 52741 (fts no) / Short supply of Anti Snake venom
11 / M/s Virchow Biotech PVt, Ltd / 52741 (fts no) / Short supply of Anti Snake venom
12 / Mediclone Biotech Pvt, ltd / 52741 (fts no) / Short supply of Anti Snake venom
13 / M/s Intas Pharmaceuticals ltd / 36885 / Approval Letter
14 / M/s Biocon Ltd / 47760 / Approval Letter
15 / M/s Cadila Healthcare ltd / 68634 (fts no) / Approval Letter
16 / M/s Gennova Biopharmaceuticals ltd / 46488 / Approval Letter
17 / M/s Indian Immunologicals ltd / 44062 / Approval Letter
18 / M/s Bharat Serum and vaccine Ltd / 45295 / Clarification letter
19 / M/s Plasmagen Biosciences pvt, ltd / 14139 / Clarification letter
20 / M/s Sanofi Pasteur India Pvt, ltd / 24485, 26652, 13014 / Approval& Clarification Letter
21 / M/s Zoetis India ltd / 28181 / Clarification letter
22 / M/s Bharat Biotech International ltd / Clarification letter
23 / M/s Roche product India pvt, ltd / 15475, 24164, 44861 / Clarification letter
24 / M/s GSK Pharmaceuticals ltd / 37620, 42887 / Clarification letter
25 / M/s Novartis Helthcare Pvt, ltd / 40113 / Clarification letter
26 / M/s Merck Specialities Pvt, ltd / 39921 / Clarification letter
Cosmetics Division
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. ASI International , New Delhi / 42184 / Approval letter
M/s. Reckitt Benckiser(India) Limited, New Delhi / 42209 / Approval 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 / 46972 / Approval Letter
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 46622 / Approval Letter
M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 100 / 46677 / Test Licence
M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 46527 / Clarification Letter
M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 46526 / Approval Letter
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 46087 / Approval Letter
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 46567 / Approval Letter
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 46452 / Approval Letter
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 46451 / Test Licence
M/s. Axis Clinical Ltd., Hyderabad-500 049 / 45677 / Approval Letter
M/s. Cipla Limited, Mumbai-400 008 / 46675 / Clarification Letter
M/s. Clinigene International Ltd., Bangalore-560 100 / 46399 / Test Licence
M/s. Fortis Clinical Research Ltd., Faridabad-121 002, Haryana / 46649 / Clarification Letter
M/s. Fortis Clinical Research Ltd., Faridabad-121002 / 46648 / Test Licence
M/s. Hetero Labs Ltd., Hyderabad-500 018 / 46499 / Clarification Letter
M/s. Kusum Healthcare Pvt. Ltd., New Delhi-110 020 / 46909 / Clarification Letter
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 47634 / Amendment + TL
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 46592 / Clarification Letter
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 46591 / Approval Letter
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 46576 / Approval Letter
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 46756 / Approval Letter
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 46757 / Approval Letter
M/s. Lotus Labs Pvt. Ltd., Chennai-600 004 / 46588 / Approval Letter
M/s. Lotus Labs Pvt. Ltd., Chennai-600 004 / 46589 / Approval Letter
M/s. Lupin Limited (Research Park), Pune-412 115 / 46577 / Approval Letter
M/s. Norwich Clinical Services Pvt. Ltd., Bangalore-560 034 / 47298 / Test Licence
M/s. Ranbaxy Laboratories Ltd., Gurgaon-122 015 / 46568 / Clarification Letter
M/s. Ranbaxy Laboratories Ltd., Gurgaon-122 015 / 48254 / Test Licence
M/s. Raptim Research Ltd., Navi Mumbai-400 701 / 46509 / Rejection Letter
M/s. Rubicon Research Pvt. Ltd., Dist. Thane, Maharashtra / 46377 / Test Licence