LETTERS FOR ISSUE ON 27.02.2015
VACCINE DIVISION
S. No. / COMPANY NAME / Dy. No. / STATUS1 / M/s Shantha Biotehnics Ltd / Clarification letter
2 / M/s Reliance life sciences Pvt, ltd / 40181 / Clarification letter
3 / M/s GSK Pharmaceuticals ltd / 49845 / Clarification letter
4 / M/s Sanofi Synthelabo India ltd / 48173 / Clarification letter
5 / M/s Paviour Pharmaceuticals Pvt ,ltd / 50505 / Clarification letter
14 / M/s Cadila Healthcare ltd / 46572 / Clarification letter
15 / M/s Novo Nordisk India Pvt. Ltd / Approval letter
16 / M/s Cliantha Research ltd / 3563, 4180, 4078, 3562 / Approval letter
17 / M/s Veeda Clinical Research pvt, ltd / 3842 / Approval letter
18 / M/s Accutest Research Laboratories pvt, ltd / 4003 / Approval letter
WRITTEN CONFIRMATION
INTERNATIONAL CELL
S. No / Firm Name / Type of Letter1. / M/s. S. Kant Healthcare Ltd., Gujarat / WC Certificate & Query letter
2. / M/s. Zim Laboratories Ltd., Nagpur / WC Certificate
3. / M/s. Cadila Healthcare Limited, Gujarat / Query Letter
REGISTRATION
S.no. / Name of applicant / Diary no. / Type of letter1. / Baxter india pv.t ld. / 5513 / Approval letter
2. / Msd pharmaceutical pvt. Ltd. / 44416 / Clarification letter
3. / Meenakshi mission hospital and research centre / Nil / Letter
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER1. / M/s New India BioPharmaPvt., Ltd., / 50462 / 76026 / Deficiency Letter
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. INC Research / 2287 / Renewal of Test License
2. / M/s. PPD / 1749 / Approval of Change in PI
3. / M/s. Boehringer / 3248 / Approval of Additional site
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Bard India Healthcare Pvt. Ltd. / 47821 / Approval (R-E-RC)
2. / M/s. Bard India Healthcare Pvt. Ltd. / 47821 / Approval (R-E-IL)
3. / M/s. Abbott Healthcare Pvt. Ltd. / 43234 / Query Letter
4. / M/s. Biomet Orthopedics India Pvt. Ltd. / Nil / Query Letter
5. / M/s. Baxter (India) Pvt. Ltd. / 38613 / Query Letter
6. / M/s. India Medtronic Pvt. Ltd. / 44763 / Query Letter
7. / M/s. Johnson & Johnson Ltd. / 42787 / Letter
8. / M/s. KCI Medical India Pvt. Ltd. / 51006 / Query Letter
9. / M/s. Surya Surgicals Industries. / 48927 / Letter
10. / M/s. St. Stone Medical Devices Pvt. Ltd.
The Director of Drugs Control, Kolkata.
The Director of Health Service, Manipur. / FTS-6486 / Letter
11. / M/s. St. Jude Medical India Pvt. Ltd. / 42531 / Approval (R-RC)
12. / M/s. St. Jude Medical India Pvt. Ltd. / 42531 / Approval (R-IL)
13. / M/s. Veiva Scientific India Pvt. Ltd. / 1019 / Approval (F-IL)
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Sysmex India Pvt. Ltd. / 49929 / Query Letter
2. / M/s. Diasys Diagnostics India Pvt. Ltd. / 51152 / Approval (IL)
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter1. / M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 100 / 4731 / Approval Letter
2. / M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 100 / 4735 / Approval Letter
3. / M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 3463 / Approval Letter
4. / M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 3636 / Approval Letter
5. / M/s. Lupin Limited (Research Park), Pune-412 115 / 1228 / Test Licence
6. / M/s. Macleods Pharmaceuticals Ltd., Andheri (East), Mumbai-400 059 / 3608 / Approval Letter
7. / M/s. Macleods Pharmaceuticals Ltd., Andheri (East), Mumbai-400 059 / 3603 / Approval Letter
8. / M/s. Micro Therapeutic Research Labs Pvt. Ltd., Chennai-600 059 / 3893 / Approval Letter
9. / M/s. Ranbaxy Laboratories Ltd., Gurgaon-122 015 / 50160 / Clarification Letter
10. / M/s. Sipra Labs Limited, Hyderabad-500 018 / 3653 / Approval Letter
WRITTEN CONFIRMATION
INTERNATIONAL CELL
S. No / Firm Name / Type of Letter1. / M/s. Sai Life Sciences, Bidar, Karnataka / WC Certificate