LETTERS FOR ISSUE ON10.06.2014
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER/ M/s Lark Lab / - / - / Letter (2)
/ M/s Zim Lab / - / - / Letter (2)
/ M/s Athena / - / - / Letter
/ M/s Dr. Reddy Lab / - / - / Letter(2)
/ M/s Cliantha / - / - / Letter
/ M/s Akums / - / - / Letter
/ M/s Cipla / - / - / Letter (2)
/ M/s Piramal / - / - / Letter
/ M/s Ajanta / - / - / Letter
/ M/s Glenmark / - / - / Letter
/ M/s Lincoln / - / - / Letter
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter
1. / M/s. Max Neeman / - / NDAC Follow-up letter
2. / M/s. Maya Clinicals / 15832 / CT NOC Approval
3. / M/s. Klinera / 17901/17855 / Change in PI Approval
4. / M/s.Sanofi / 14431/18934 / Change in PI Approval
5. / M/s. Biogen Idec / 5121 / Change in study site approval
6. / M/s. Novartis / 4759/7923/62075 / CT NOC/Change in PI & Change in study site approval letters
7. / M/s. Theoram / 12253 / Clarification Letter
8. / M/s. Siro / - / NDAC follow-up letter
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter
/ M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 18609 / Approval Letter
/ M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 18749 / Approval Letter
/ M/s. Alembic Pharmaceuticals Ltd., Vadodara-390003 / 18744 / Approval Letter
/ M/s. Azidus Laboratories Ltd., Chennai-600 048 / 17445 / Clarification Letter
/ M/s. Bio Scientific Research Laboratories (India) Pvt. Ltd., Dist. Thane-401 104 / 20436 / Approval Letter
/ M/s. Cliantha Research Limited, Ahmedabad-380 054 / 17922 / Approval Letter
/ M/s. Dr. Reddy’s Laboratories Ltd., Hyderabad-500 034 / 18422 / Approval Letter
/ M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 18579 / Approval Letter
/ M/s. Lambda Therapeutic Research Ltd., Navi Mumbai-400614 / 19181 / Approval Letter
/ M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 15155 / Clarification Letter
/ M/s. Lotus Labs Pvt. Ltd., Chennai-600004 / 17422 / Approval Letter
/ M/s. Lotus Labs Pvt. Ltd., Chennai-600004 / 18436 / Approval Letter
/ M/s. Lupin Bioresearch Center, Pune-411 021 / 18772 / Approval Letter
/ M/s. Micro Therapeutic Research Labs Pvt. Ltd., Chennai-600 059 / 17576 / Clarification Letter
/ M/s. Micro Therapeutic Research Labs Pvt. Ltd., Chennai-600 059 / 20740 / Clarification Letter
/ M/s. Micro Therapeutic Research Labs Pvt. Ltd., Coimbatore-641029 / 12831 / Approval Letter
/ M/s. Ranbaxy Laboratories Ltd., New Delhi-110 019 / 19975 / Approval Letter
/ M/s. Reliance Life Sciences Pvt. Ltd., Navi Mumbai-400 701 / 18735 / Clarification Letter
/ M/s. Semler Research Center Pvt. Ltd., Bangalore-560078 / 21522 / Approval Letter
/ M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 18124 / Approval Letter
/ M/s. Torrent Pharmaceuticals Ltd. (Research Centre), Gujarat / 18853 / Approval Letter
/ M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 22080 / Approval Letter
/ M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 20301 / Approval Letter
/ M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 19718 / Approval Letter
/ M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 23791 / Approval Letter
ONLY TEST LICENCE FOR BE
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter
/ M/s. Alkem Laboratories Ltd., Dist: Raigad -410208 / 15311 / Test Licence
/ M/s. Axis Clinical Ltd., Hyderabad-500 049 / 19344 / Test Licence
/ M/s. Cadila Pharmaceutical Ltd., Dholka-387 810, Ahmedabad / 19231 / Test Licence
/ M/s. Cadila Pharmaceutical Ltd., Dholka-387 810, Ahmedabad / 19230 / Test Licence
/ M/s. Reliance Life Sciences Pvt. Ltd., Navi Mumbai-400 701 / 20048 / Test Licence
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUS
/ M/s. Advanced Life Sciences Pvt. Ltd. / 15886 / Query Letter
/ M/s. Bard India Healthcare Pvt. Ltd. / 16328 / Query Letter
/ M/s. Bangalore Surgicals. / 16714 / Query Letter
/ M/s. Bangalore Surgicals. / 16713 / Query Letter
/ M/s. Bangalore Surgicals. / 16716 / Query Letter
/ M/s. Covidien Healthcare India Pvt. Ltd. / 15366 / Query Letter
/ M/s. Covidien Healthcare India Pvt. Ltd. / 16628 / Query Letter
/ M/s. Fresenius Medical Care India Pvt. Ltd. / 372 / Query Letter
/ M/s. India Medtronic Pvt. Ltd. / 14878 / Query Letter
/ M/s. India Medtronic Pvt. Ltd. / 14878 / Query Letter
/ M/s. Johnson & Johnson Ltd. / 10497 / Query Letter
/ M/s. Johnson & Johnson Ltd. / 17634 / Query Letter
/ M/s. Johnson & Johnson Ltd. / 16314 / Query Letter
/ M/s. KCI Medical India Pvt. Ltd. / FTS-26650 / Query Letter
/ M/s. Pharma Leaf India Pvt. Ltd. / 19477 / Query Letter
/ M/s. Totipotent SC Scientific Product Pvt. Ltd. / 43096 / Query Letter
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS
/ M/s. BioMerieux India Pvt. Ltd. / 18371 / Query Letter
/ M/s. Cosmos Advanced Diagnostics LLP. / 20806 / Query Letter
/ M/s. Kibion AB, Business. / 55062 / Clarification Letter
/ M/s. Roche Diagnostics India Pvt. Ltd. / 3543 / Query Letter
/ M/s. Sysmex India (P) Ltd. / 15429 / Query Letter
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER/ M/s Lark Lab / - / - / Letter (2)
/ M/s Zim Lab / - / - / Letter (2)
/ M/s Athena / - / - / Letter
/ M/s Dr. Reddy Lab / - / - / Letter(2)
/ M/s Cliantha / - / - / Letter
/ M/s Akums / - / - / Letter
/ M/s Cipla / - / - / Letter (2)
/ M/s Piramal / - / - / Letter
/ M/s Ajanta / - / - / Letter
/ M/s Glenmark / - / - / Letter
/ M/s Lincoln / - / - / Letter
/ M/s Allergan / - / - / Letter
/ M/s Bharat Serum / - / - / Letter
IMPORT
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
/ Ace Pharma / 19253 / Approval Letter
/ Ace Pharma / 19254 / Approval Letter
/ Nandlal Bankatlal Pvt. Ltd. / 19258 / Approval Letter
/ Nandlal Bankatlal Pvt. Ltd. / 19259 / Approval Letter
/ Ind-Swift Laboratories Limited / 19165 / Approval Letter
/ Ind-Swift Laboratories Limited / 19164 / Approval Letter
/ Param Pharma / 19250 / Approval Letter
/ Param Pharma / 19248 / Approval Letter
/ Param Pharma / 19249 / Approval Letter
/ Param Pharma / 19251 / Approval Letter
/ Param Pharma / 19252 / Approval Letter
/ Pratistha Pharma, / 19168 / Approval Letter
/ Pratistha Pharma, / 19167 / Approval Letter
/ Pratistha Pharma, / 19166 / Approval Letter
/ Shamshree Lifesciences Ltd. / 19353 / Approval Letter
/ Associated Biotech / 19261 / Approval Letter
/ Medicef Pharma / 19262 / Approval Letter
/ Nirma Ltd. / 19265 / Approval Letter
/ Unichem Laboratories Ltd., / 19274 / Approval Letter
/ Wyeth Limited (C/o. M/s. Espi Industries and Chemicals Pvt. Ltd.) / 19317 / Approval Letter
/ Geltec Private Limited / 19519 / Approval Letter
/ Lupin Limited. / 19425 / Approval Letter
/ Inspira Bio Pharm Pvt. Ltd. / 19485 / Approval Letter
/ Laborate Pharmaceuticals (India) Ltd., / 19494 / Approval Letter
/ Laborate Pharmaceuticals (India) Ltd., / 19495 / Approval Letter
/ Nitin Lifesceinces Ltd. Unit-III / 19496 / Approval Letter
/ Nitin Lifesceinces Ltd. Unit-III / 19497 / Approval Letter
/ Scott Edil Pharmacia Ltd. / 17916 / Approval Letter
/ Vita Pharma Agencies / 17916 / Clarification Letter
/ Novartis India Ltd. / 20804 / Clarification Letter
/ Serdia Pharmaceuticals (I) Pvt. Ltd. / 17084 / Clarification Letter
/ Inspira Biopharma Pvt. Ltd. / 19485 / Clarification Letter
REGISTRATION
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
/ WINDLAS HEATLHCARE PVT. LTD / 20875 / APPROVAL LETTER
/ ARCHERCHEM / 12733 / APPROVAL LETTER
/ DIVINNE SBR INTERNATIONAL / 11976 / APPROVAL LETTER
/ ANANTCO ENTERPRISES PVT. LTD. / 15985 / APPROVAL LETTER
/ TEVA PHARAMCETUICALS & CHEMICALS INDUSTRIES INDIA PVT. LTD. / 11435
/ UNICHEMIE INTERNATIONAL / 18732 / AMENDED LETTER
/ TATTVA PHARMA EXIM SERVICES / 10976
/ UCB INDIA PVT. LTD. / 9871
/ DIVINNE SBR INTERNATIONAL / 10064
/ PFIZER PRODUCTS INDIA PVT. LTD. / 16404
/ B.M CHEMIE / 65173
/ ALLIANCE PHARMA AGENCIES / 65345
/ SHAH TC / 57464,13000 / 2
/ DR. REDDY LABORATORIES LTD. / 10214
/ UNICHEMIE INTERNATIONAL / 12414
/ RUSKIN CHEMIPHARM / 2692
/ TEVA PHARAMCETUICALS & CHEMICALS INDUSTRIES INDIA PVT. LTD. / 4702
/ ORGANON INDIA PVT. LTD. / 8969
/ MERCK SPECIALITES PVT. LTD. / 64753
/ RENAISSANCE PHARMACEUTICALS / 10341
MISC./RULE-37/SHELF LIFE
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
/ UNICHEM LABORATORY LTD. / REJECTION LETTER
/ ENCUBE ETHICALS PVT. LTD. / 15279 / APPROVAL LETTER
/ SANOFI SYNTHELABO INDIA LTD. / 23200 / AMENDED LETTER
/ ASTRAZENECA PHARMA INDIA LTD. / 60940
/ INFUSION PHARMA PVT. LTD. / 9294 / CLARIFICATION LETTER
/ MEDOPHARMA PVT. LTD. / 6367 / CLARIFICATION LETTER
/ ORGANON INDIA PVT. LTD. / 20642 / CLARIFICATION LETTER
NEW DRUG
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
/ M/s. GSK / - / Clarification Letter
/ M/s. Lupin / - / Letter
/ M/s. Macleods / - / Letter
/ Dr. Madhusudhan, AIIMS / - / Clarification Letter
/ M/s. Sandor / - / Clarification Letter
/ Dr. Kalpagam, Jamai- Osmania / - / Clarification Letter
/ M/s. Intervet / - / Clarification Letter
/ M/s. Emcure / - / Clarification Letter
/ M/s. Zuventus / - / Clarification Letter (4)
/ M/s. Hetero / - / Approval Letter
/ M/s. Apothecon Pharmaceuticals / - / Clarification Letter
/ M/s. Suleshvari / - / Clarification Letter
WRITTEN CONFIRMATION
S. No / Firm Name / Type of Letter1. / M/s. MSN Organics Pvt. Ltd. / Clarification Letter
2. / M/s. Apex Healthcare Ltd. / Letter
3. / M/s. Parabolic Drugs Ltd. / Written Confirmation Letter
VACCINE DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s Sanofi Synthelabo (india) Ltd / 19799 / Approval Letter
2 / M/s Intervet India Pvt, ltd / 14320 / Approval Letter
NDAC MEETING VACCINE
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s MSD Pharmaceuticals Pvt, Ltd / Clarification Letter
2 / M/s Serum Institute of India Ltd / Clarification Letter
3 / M/s Biological E. Ltd / Clarification Letter
4 / M/s Bharat Biotech International Ltd / Clarification Letter
5 / M/s GSK Pharmaceuticals Ltd / Clarification Letter
6 / M/s Wyeth Ltd / Clarification Letter