LETTERS FOR ISSUE ON 26.08.2014
LVP DIVISION
S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS01 / M/s. Global Pharma Healthcare, Chennai / Approval
02 / M/s. Unique Pharmaceutical, Gujarat / 46775 / Approval
03 / M/s. Unique Pharmaceutical, C/o M/s. Unique Pharmaceuticals, Gujarat / 45943 / Approval
04 / M/s. Nirma Ltd., Gujarat / 22577 / Approval
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter1. / M/s. Actimus Biosciences Pvt. Ltd., Visakhapatnam-530 003 / 24215 / Approval Letter
2. / M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 18739 / Approval Letter
3. / M/s. APL Research Centre, Hyderabad-500 072 / 12024 / Amendment Letter
4. / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 17820 / Approval Letter
5. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 24413 / Approval Letter
6. / M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 29556 / Amendment Letter
7. / M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 31468 / Amendment Letter
8. / M/s. GVK Biosciences Pvt. Ltd., Ahmedabad-380 051 / 30066 / Approval Letter
9. / M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 30994 / Clarification Letter
10. / M/s. LifeSan Clinical Research, Mumbai-400 055 / 18351 / Rejection Letter
11. / M/s. Micro Therapeutic Research Labs Pvt. Ltd., Chennai-600 059 / 14104 / Rejection Letter
12. / M/s. Mylan Laboratories Limited, Hyderabad-500 003 / 47075 / Approval Letter
13. / M/s. RA Chem Pharma Ltd., Balanagar, Hyderabad-500 037 / 25749 / Clarification Letter
14. / M/s. Sitec Labs Pvt Ltd, Navi Mumbai-400701 / 28230 / Amendment Letter
15. / M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 19020 / Amendment Letter
16. / M/s. Synchron Research Services Pvt. Ltd., Ahmedabad-380 054 / 29384 / Approval Letter
17. / M/s. Torrent Pharmaceuticals Ltd., Ahmedabad-380 009 / 10213 / Rejection Letter
18. / M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 22970 / Rejection Letter
19. / M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 20302 / Approval Letter
20. / M/s. Watson Pharma Pvt Ltd ., Navi Mumbai-400614 / 13477 / Approval Letter
21. / M/s. Watson Pharma Pvt Ltd ., Navi Mumbai-400614 / 13490 / Approval Letter
22. / M/s. Watson Pharma Pvt Ltd., Navi Mumbai-400614 / 24917 / Approval Letter
ONLY TEST LICENCE FOR BE
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter1. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 19246 / Test Licence
2. / M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 21379 / Test Licence
3. / M/s. Emcure Pharmaceuticals Limited, Pune-411 026 / 24367 / Test Licence
4. / M/s. Lupin Bioresearch Center, Pune-411 021 / 28584 / Test Licence
5. / M/s. RA Chem Pharma Ltd., Balanagar, Hyderabad-500 037 / 25748 / Test Licence
6. / M/s. Ranbaxy Laboratories Ltd., Gurgaon-122 015 / 31276 / Test Licence
7. / M/s. Synchron Research Services Pvt. Ltd., Ahmedabad-380 054 / 30445 / Test Licence
8. / M/s. Watson Pharma Pvt Ltd ., Navi Mumbai-400614 / 32001 / Test Licence
9. / M/s. Watson Pharma Pvt Ltd., Navi Mumbai-400614 / 30191 / Test Licence
NEW DRUG
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / M/s. Boehringer Ingelheim / - / Query Letter
2. / M/s. Lupin Limited / - / Query Letter
3. / Dr. T.S. Ganesan / - / Query Letter
4. / Dr. D.P.Attrey / - / Query Letter
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT1. / M/s. Relax Pharmaceuticals Pvt. Ltd., / 43491 / Letter
2. / M/s. Santo Formulations, / 44309 / Letter
3. / M/s. Softech Pharma Pvt. Ltd., / 42495 / Clarification Letter
4. / M/s. Wallace Pharmaceuticals Pvt. Ltd., / 42752 / Letter
5. / M/s. Sun Pharmaceuticals Industries Ltd., / 17969 / Approval Letter
6. / M/s. Vibro Pharma Pvt. Ltd., / 65137 / Clarification Letter
7. / M/s. Vibro Pharma Pvt. Ltd., / 65137 / Letter
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Boston Scientific India Pvt. Ltd. / 30518 / Approval (R-RC)
2. / M/s. Boston Scientific India Pvt. Ltd. / 30518 / Approval (R-IL)
3. / M/s. St. Jude Medical India Pvt. Ltd. / 25925 / Approval (E-RC)
4. / M/s. St. Jude Medical India Pvt. Ltd. / 25925 / Approval (E-IL)
5. / M/s. Deep Medical Devices Pvt. Ltd. / 29861 / Approval (F-IL)
6. / M/s. Synthes Medical Pvt. Ltd. / 26661 / Approval (F-IL)
7. / M/s. Bard India Healthcare Pvt. Ltd. / 19877 / Approval (R-IL)
8. / M/s. Bangalore Surgicals. / 26615 / Approval (R-IL)
9. / M/s. Medi Plus India Ltd. / 27984 / Approval Letter
10. / The State Drugs Controller, Haryana (CLAA)
The Deputy Drugs Controller (I), Ghaziabad (CLAA)
(M/s. Mais India Medical Devices Pvt. Ltd.) / FTS-42403 / Approval Letter
11. / The Commissioner, Gujarat (CLAA)
The Deputy Drugs Controller (I), Ahmedabad (CLAA)
(M/s. Polymer Technologies International (EOU) ) / FTS-43991 / Approval Letter
12. / The Commissioner, Gujarat (CLAA)
The Deputy Drugs Controller (I), Ahmedabad (CLAA)
(M/s. Shahajanand Medical Technologies Pvt. Ltd.) / FTS-44746 / Approval Letter
13. / M/s. Faith Biotech (P) Ltd. / 26738 / Letter
14. / M/s. St. Jude Medical India Pvt. Ltd. / 21069 / Letter
15. / M/s. D S Overseas. / 15911 / Query Letter
16. / M/s. Emergo (India) Consulting Pvt. Ltd. / 15222 / Query Letter
17. / M/s. Evolutis India Pvt. Ltd. / 5467 / Query Letter
18. / M/s. Johnson & Johnson Ltd. / 22682 / Query Letter
19. / M/s. Kimberly-Clark Hygiene Products Pvt. Ltd. / 25127 / Query Letter
20. / M/s. Medihelp Healthcare Pvt. Ltd. / 18273 / Query Letter
21. / M/s. Nutri Synapz Therapeutix Pvt. Ltd. / FTS-20628 / Clarification Letter
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Arnika Healthcare Pvt. Ltd. / 27475 / Approval (IL)
2. / M/s. Beckman Coulter India Pvt. Ltd. / 27033 / Approval (IL)
3. / M/s. Green Apple Medical Systems. / 27067 / Approval (IL)
4. / M/s. R S Surgicals Pvt. Ltd. / 31966 / Approval (IL)
5. / M/s. Roche Diagnostics India Pvt. Ltd. / 27918 / Approval (IL)
6. / M/s. Sysmex India (P) Ltd. / 26948 / Approval (IL)
7. / M/s. Sysmex India (P) Ltd. / 25471 / Approval (IL)
8. / M/s. Avantor Performance Materials India Ltd. / 27524 / Approval (E-IL)
9. / M/s. Bio-Rad Laboratories (India) Pvt. Ltd. / 30404 / Approval (E-IL)
10. / M/s. Sysmex India Pvt. Ltd. / 26363 / Approval (TL)
11. / M/s. Roche Diagnostics India Pvt. Ltd. / 26411 / Approval Letter
12. / The State Drugs Controller, Haryana / Nil / Letter
13. / M/s. Beauty Queen Cosmetics Pvt. Ltd. / 26267 / Query Letter
14. / M/s. Stedman Pharmaceuticals Pvt. Ltd. / 27921 / Query Letter
M/s. Aspen Laboratories Pvt. Ltd. / 30461 / Letter
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER1. / M/s MSN Organics Pvt. Ltd., / 17701 / 26621 / Deficiency Letter
VACCINE DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s Novo Nordisk India Pvt Ltd / 13242 / Clarification letter
2 / M/s Shantha Biotechnics Limited / Approval letter