LETTERS FOR ISSUE ON 13.02.2015
LVP DIVISION
S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS01 / M/s. Venus Remedies, Haryana / 5282 / Approval
02 / M/s. Vetoquinol India Animal C/o. M/s. Denis Chem Lab Ltd., Gujarat / 4360 / Approval
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letterM/s. Accutest Research Laboratories (I) Pvt. Ltd., Ahmedabad-380 015 / 57850 / Reminder Query
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 1722 / Approval Letter
M/s. Actimus Biosciences Pvt. Ltd., Visakhapatnam-530 003 / 49148 / Approval Letter
M/s. Alkem Laboratories Ltd., Maharashtra / 617 / Clarification Letter
M/s. Axis Clinical Ltd., Hyderabad-500 049 / 1917 / Approval Letter
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 614 / Test Licence
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 615 / Test Licence
M/s. Cipla Limited, Mumbai-400 013 / 2169 / Test Licence
M/s. Cliantha Research Ltd., Ahmedabad-380 054 / 1694 / Clarification Letter
M/s. Dr. Reddy’s Laboratories Ltd., Hyderabad-500 034 / 49789 / Test Licence
M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 2007 / Clarification Letter
M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 2008 / Approval Letter
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 12212 / Reminder Query
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 034 / 538 / Test Licence
M/s. Lupin Limited (Research Park), Pune-412 115 / 1959 / Test Licence
M/s. Manipal Acunova Ltd., Mangalore-575 001 / 1062 / Approval Letter
M/s. Ranbaxy Laboratories Ltd., Gurgaon-122 015 / 1976 / Test Licence
M/s. Ranbaxy Laboratories Ltd., New Delhi / 1863 / Clarification Letter
M/s. Synapse Labs Pvt. Ltd., Kharadi, Pune-411 014 / 3595 / Approval Letter
M/s. Torrent Pharmaceuticals Ltd. (Research Centre), Gujarat / 1763 / Approval Letter
M/s. Torrent Pharmaceuticals Ltd. (Research Centre), Gujarat / 1762 / Approval Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 1691 / Approval Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 1536 / Approval Letter
M/s. Vimta Labs Ltd., Hyderabad-500051 / 49797 / Approval Letter
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400 614 / 11047 / Reminder Query
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400 614 / 57850 / Reminder Query
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400 614 / 2600 / Additional Study Centre
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400614 / 2103 / Amendment Letter
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400614 / 2103 / Test Licence
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400614 / 1950 / Approval Letter
COSMETIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. G3 Cosmecuticals, Chennai / 47000 / Approval Letter
M/s. USV Limited, Mumbai / 48896 / Approval Letter
M/s. PZ Cussons India Private Limited, Mumbai / 48422 / Approval Letter
M/s. Wella Iindia Haircosmetics Private Limited, Mumbai / 49153 / Approval Letter
M/s. Quest Retail Pvt. Ltd, Jaipur / 47846 / Approval Letter
M/s Gardenia Cosmetics Pvt. Ltd, Mumbai / 50950 / Approval Letter
M/s. Sesderma India Pvt. Ltd, New Delhi / 48784 / Approval Letter
M/s. Sesderma India Pvt. Ltd, New Delhi / 48412 / Approval Letter
M/s. Siberian Health International Private Limited, New Delhi / 45348 / Approval Letter
M/s. Siberian Health International Private Limited, New Delhi / 47977 / Deficiency Letter
M/s. Skin innovation Pvt. Ltd., Maharashtra / 49537 / Deficiency Letter
M/s. Sephora Cosmetics Private Limited, New Delhi / 48925 / Deficiency Letter
M/s. Nuga Medical India Pvt. Ltd, Noida / 49140 / Deficiency Letter
M/s. Ishwari Prasad & Sons Pvt. Ltd, Mumbai / 48044 / Deficiency Letter
M/s. PKB Exports, Madurai Tamilnadu / FTS NO. 74910 / Deficiency Letter
M/s. Zeus Worldwide trading, Mumbai / 50501 / Deficiency Letter
M/s. Geosmatic Cosmeceuticals & Cosmocare Pvt. Ltd, Pune / 50616 / Deficiency Letter
M/s. Zeus Worldwide trading, Mumbai / 50502 / Deficiency Letter
M/s. Perfect Way Trading, Maharashtra / 51229 / Deficiency Letter
EXPORT NOC
INTERNATIONAL CELL
S. No / Firm Name / Type of Letter1. / M/s. Meyer Organics Pvt. Ltd., Thane / Letter
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. Sanofi / 259 / TL & Export NOC Approval letters
2. / M/s. Pfizer / - / Letter
3. / M/s. Accutest / - / Letter
4. / M/s. Max Neeman / 433 / TL Approval letter
5. / M/s. BIOCAD / 2912 / Amendment in Export NOC Approval Letters
6. / M/s. Novartis / 1927 / Change in PI Approval Letter
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTERM/s BoehringerIngelheim India Pvt. Ltd., / - / - / SEC Letter
M/s MSD / - / - / SEC Letter
M/s Sun Pharma / 47935, 47935, 49877 / - / Approval Letter (2), Test License
M/s Bharat Serum / 57252 / - / CT NOC
MEDICAL DEVICE DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. Boston Scientific India Pvt. Ltd. / 42976 / Query letter
M/s. Stryker India Pvt. Ltd. / 46564 / Query letter
M/s. India Medtronic Pvt. Ltd. / 44763 / Letter
M/s. Baxter (India) Private Limited / 47666 / Query Letter
Abbot Healthcare Pvt. Limited / 44671 / Query letter
M/s. Stryker India Pvt. Ltd., / 46545 / Query letter
M/s. Plexus Medica / 47327 / Query Letter
M/s. Johnson & Johnson Limited / 46007 / Query letter
M/s. Span Healthcare Private Limited / 45312 / Query letter
M/s. Boston Scientific India Pvt. Ltd. / 42812 / RC & Form 10
M/s. Kentron Biotechnology Pvt. Ltd. / 523 & FTS no. 608 / Test Licence
M/s. Lars Medicare Pvt. Ltd., / FTS-1358/15 / CLAA Letter `
M/s. Harsoria Heathcare Pvt. Ltd / FTS-2090/2015 / CLAA Letter
M/s. Lakhani Medicare Pvt. Ltd., / FTS No. 72750 / CLAA Lettter
M/s. BSN Medical Pvt. Ltd. / 41993 / RC & Form 10
M/s. Serum Institute of India Limited / 43926 / RC
M/s. Sahajanand Medical technologies Pvt. Ltd.,
Surat / FTS-316/2015 / CLAA Letter
DIAGNOSTICS DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. Roche Diagnostics India Pvt. Ltd., / 51272 / Form 10
M/s. Transasia Bio Medicals Limited / 51224 / Form 10
M/s. Alere Medical Pvt. Ltd., / 49105 / Form 10
M/s. Roche diagnostics India Pvt. Ltd. / 44205 / Query Letter
LETTER PERTAINING TO IMPORT
S.no. / Name of applicant / Diary no. / Type of letterGsk pharmaceuticals ltd. / 3072,3071,3073,3070,
40343,40238,3074 / 07 approval letter
Abbott india ltd. / 2758 / Amended letter
Fulford india ltd. / 50443 / Amended letter
LETTER PERTAINING TO REGISTRATION
S.no. / Name of applicant / Diary no. / Type of letterGsk pharmaceuticals ltd. / 50265,1549 / 02 approval letter
Johnson & johnson ltd. / 1446,42719 / 02 approval letter
Eisai pharmaceuticals india pvt. Ltd. / 49183 / Approval letter
Scientific remedies pvt. Ltd. / 48874 / Approval letter
Boehringer ingelheim india pvt. Ltd. / 51330 / Approval letter
G.c. chemie pharmie ltd. / 1915 / Approval letter
Shah tc / 262 / Approval letter
Symbio generrics india pvt. Ltd. / 1780 / Approval letter
Novartis india ltd. / 32024 / Approval letter
Pfizer products india pvt. Ltd. / 42714,44177 / Amended letter
Pfizer ltd. / 44177 / Calrification letter
Helpro heatlh products & services / 50737 / Calrification letter
A.menarini india pvt. Ltd. / 45338 / Calrification letter
Biomet orthopedic india pvt. Ltd. / 28682 / Calrification letter
Shah tc / 48820 / Calrification letter
Teva pharmaceutical / 44809, / 02 calrification letter
LETTER PERTAINING TO RULE-37/SHELF LIFE
S.no. / Name of applicant / Diary no. / Type of letterSanofi synthelabo india ltd. / 833 / Clarification letter
Tuton pharmaceutial / 50644 / Approval letter