LETTERS FOR ISSUE ON 15.01.2015
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter1. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 50316 / Approval Letter
2. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 50356 / Approval Letter
3. / M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 49586 / Clarification Letter
4. / M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 50399 / Approval Letter
5. / M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 50087 / Approval Letter
6. / M/s. Dr. Reddy’s Laboratories Ltd., Hyderabad-500 034 / 50136 / Test Licence
7. / M/s. Hetero Labs Ltd., Hyderabad-500 018 / 50506 / Test Licence
8. / M/s. Hetero Labs Ltd., Hyderabad-500 018 / 50510 / Test Licence
9. / M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 50139 / Approval Letter
10. / M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 50482 / Approval Letter
11. / M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 50105 / Test Licence
12. / M/s. Lupin Limited (Research Park), Pune-412 115 / 50544 / Approval Letter
13. / M/s. Reliance Life Sciences Pvt. Ltd., Navi Mumbai-400 701 / 45963 / Additional Study Center
14. / M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 45128 / Amendment Letter
15. / M/s. Vimta Labs Ltd., Hyderabad-500051 / 50181 / Approval Letter
16. / M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400614 / 44202 / Rejection Letter
17. / M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400614 / 50112 / Test Licence
WRITTEN CONFIRMATION
INTERNATIONAL CELL
S. No / Firm Name / Type of Letter1. / M/s. Deccan Nutraceuticals Pvt. Ltd., Dist. Pune. / Letter
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT1. / M/s. Creative Health care / 42921 / Letter
2. / M/s. Akums Drugs / 65991 / Letter
3. / M/s. Akums Drugs / 43780 / Letter
4. / M/s.Sun Pharma / 50940 / Amendment Letter
5. / M/s. Fresenius Medical Care / 46055 / Amendment Letter
6. / M/s. Bayer Pharmaceuticals / 46522 / Letter
7. / M/s. Mepromax Lifesciences / 68100 / Letter
8. / M/s. Aqua Vitoe / 48688 / Letter
9. / M/s. Curetech Skincare / 49228 / Letter
10. / M/s. Noel Pharma / 50542 / Letter
VACCINE DIVISION
S. No. / COMPANY NAME / Dy. No. / STATUS1 / M/s Max Neeman Medical International Ltd / Cancellation order
2 / M/s Syngene International Ltd / Clarification letter
3 / M/s GSK Asia Pvt. Ltd / CDL Letter
4 / M/s Reliance Life Sciences Pvt, ltd / 45491, 42424, 41112,26262, / Approval letters
5 / M/s GlaxoSmithKline Pharmaceuticals Ltd / 46461 / Clarification letter
6 / M/s Biological E. Ltd / 48375 / Clarification letter
7 / M/s Intervet India Pvt. Ltd / 41860 / Clarification letter
8 / M/s Wyeth Limited / 38334 / Clarification letter
9 / M/s Novartis Healthcare Private Ltd / 34152, 45048, 45559 / Clarification letter
10 / M/s Organon (India) Pvt. Ltd / 45063 / Clarification letter
11 / M/s Chiron Behring Vaccine Pvt. Ltd / 47101 / Clarification letter
REGISTRATION
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / DAIWAT CHEMICALS / 46040 / CLRIFICATION LETTER
2. / NOVARTIS HEALTH CARE PVT. LTD. / 41310 / CLRIFICATION LETTER
3. / DIVINNE SBR / 34685 / CLRIFICATION LETTER
4. / UNICHEIEMIE INTERNATIONAL / 49972 / CLRIFICATION LETTER
5. / RUSKIN CHEMIPHARMA / 42064 / CLRIFICATION LETTER
6. / SHAH TC OVERSEASE PVT. LTD. / 38448 / CLRIFICATION LETTER
7. / CHR HANSEN INDIA PVT. LTD. / 44523 / CLRIFICATION LETTER
8. / ORBIT LIFESCIENCES PVT. LTD. / 48343 / CLRIFICATION LETTER
9. / ROCHE PRODUCTS INDIA PV.T LTD. / 43581 / CLRIFICATION LETTER
MISC
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / THE IND SWIFT LTD. / NIL / CLRIFICATION LETTER
2. / SUN PHARMACEUTICAL INDUSTRIES LTD. / NIL / CLRIFICATION LETTER
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. Fortis / 4933 / CT NOC Approval
2. / M/s. GSK / 32791/44799 / TL Approval Letter
3. / M/s. Novartis / 31136/26154/24699 / CT NOC & TL Approval letters
4. / M/s. PPD / 50819 / TL Approval Letter
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER1. / M/s Shasun Pharmaceuticals Ltd., / 45864 / 68341 / Query Letter
2. / M/s Lupin Limited., / 42898 / 63252 / Query Letter
3. / M/s Zim Laboratories Ltd., / 57151 / - / Approval Letter
MEDICAL DEVICE DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. MN Solutions / 39779 / RC
2. / M/s. IOL Asia, Delhi / 44534 / F-10
3. / M/s. Cook India Medical Devices Pvt. Ltd., Chennai / 44522 / E-RC & E-F-10
4. / M/s. Nobel Biocare India pvt.Ltd., Panvel / 37520 / RC & F-10
5. / M/s. Axon Medical Solutions Pvt. Ltd., Delhi / 45692 / RC
6. / M/s. Sera LIfecare, Delhi / 48858 / F-10
7. / M/s. LIfecare Devices Pvt. Ltd., Mumbai / 45804 / RC
8. / M/s. Meril Life Sciences Pvt. Ltd., Vapi / 38288 / CT-Permission
9. / M/s. India Medtronic Pvt. Ltd., Mumbai / 29178 / CT-Permission
10. / M/s. India Medtronic Pvt. Ltd., Mumbai / 29178 / Test License
11. / M/s. Nobel Biocare India pvt.Ltd., Panvel / 43856 / Amendment Letter
12. / M/s. Neurosynaptic Communications Pvt. Ltd., / FTS no. 64590 / Clarification Letter
DIAGNOSTICS DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Sysmex India (P) Ltd., Mumbai / 47412 / F-10
2. / M/s. Compact Diagnostics (India) Pvt Ltd., New Delhi / 20732 / F-10
3. / M/s. Matrix Labs, Chennai / 44723 / Test License
4. / M/s. Roche Diagnotics India Pvt. Ltd., Mumbai / 42947 / E-F-10
5. / M/s. Vishwa Trading, Surat / 47271 / F-10
6. / M/s. Sysmex India (P) Ltd., Mumbai / 42076 / F-10
7. / M/s. Werfen Medical India Pvt. Ltd., New De;lhi / 46282 / E-F-10
8. / M/s. Sirus Biocare Pvt. Ltd., Kol / 46731 / F-10
9. / M/s. Beckman Coulter India pvt. Ltd., Mumbai / 43409 / E-F-10
10. / M/s. Ashish Interchem Pvt. Ltd., Mumbai / 46283 / Amendment letter
NEW DRUG
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / M/s. Johnson & Johnson Ltd / - / TL Letter (2)
2. / M/s Ajanta Pharma Ltd. / - / Query Letter
3. / M/s. Hetero Drug Ltd. / - / TL Letter
4. / Dr. R.S. Paranjape / - / TL Letter (2)
5. / M/s. Boehringer Ingelheim Pvt Ltd / - / TL Letter
6. / M/s Alkem Lab Ltd. / - / CT-NOC Letter
7. / M/s. Intas Pharmaceuticals Ltd / - / CT-NOC Letter