LETTERS FOR ISSUE ON03.09.2014

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 / 33402 / Approval Letter
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 33541 / Approval Letter
M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 33437 / Approval Letter
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 33966 / Approval Letter
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 35774 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 33643 / Approval Letter
M/s. GVK Biosciences Pvt. Ltd., Ahmedabad-380 051 / 33550 / Clarification Letter
M/s. GVK Biosciences Pvt. Ltd., Ahmedabad-380 051 / 33971 / Approval Letter
M/s. GVK Biosciences Pvt. Ltd., Hyderabad-500 038 / 33610 / Approval Letter
M/s. Lupin Bioresearch Center, Pune-411 021 / 33019 / Approval Letter
M/s. Torrent Pharmaceuticals Ltd., Ahmedabad-380009 / 33744 / Clarification Letter
M/s. Vimta Labs Ltd., Hyderabad-500051 / 36168 / Approval Letter
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400614 / 33926 / Approval Letter

ONLY TEST LICENCE FOR BE

S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 34130 / Test Licecne
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 34052 / Test Licecne
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 33875 / Test Licecne
M/s. Manipal Acunova Ltd., Manipal AcuNova KMC CPU, Mangalore-575 001 / 33841 / Test Licecne
M/s. Synapse Labs Pvt. Ltd., Kharadi, Pune-411 014 / 34640 / Test Licecne

TEST LICENCES

S. No. / Name of the Company / Diary No. / Type of Letter
Aurobindo Pharma Ltd / 30380, 44791, 36595, 54017 / Approval Letter
Orbicular Pharmaceutical Technologies Pvt Ltd / 23104, 34140, 35932, 52902 / Approval Letter
Orbicular Pharmaceutical Technologies Pvt Ltd / 23106, 34148, 35932, 52902 / Approval Letter
Perrigo Laboratories India Pvt Ltd / 30069, 44375, 35900, 52839 / Approval Letter
Perrigo Laboratories India Pvt Ltd / 30070, 44373, 35900, 52839 / Approval Letter
Perrigo Laboratories India Pvt Ltd / 30071, 44371, 35900, 52839 / Approval Letter
Resonance Laboratories Pvt Ltd / 30119, 44571, 36009, 53420 / Approval Letter
Resonance Laboratories Pvt Ltd / 30124, 44569, 36010, 53423 / Approval Letter
Resonance Laboratories Pvt Ltd / 30126, 44937, 36011, 53426 / Approval Letter
Resonance Laboratories Pvt Ltd / 30127, 44936, 36012, 53429 / Approval Letter
Resonance Laboratories Pvt Ltd / 30125, 44563 / Approval Letter
USV Ltd / 30327, 44719, 35843, 52862 / Approval Letter
Olive Healthcare / 36770, 54152 / Amendment Letter
Suven Life Sciences Ltd / 36147, 53223 / Amendment Letter
Suven Life Sciences Ltd / 36148, 53221 / Amendment Letter
Max Neeman Medical International Ltd / 33775, 49567 / Deficiency Letter
Orchid Healthcare / 34090, 50497 / Deficiency Letter
Strides Arcolab Ltd / 33758, 49612 / Deficiency Letter
Sunglow Pharmaceuticals Pvt Ltd / 33263, 48677, 33266, 48716 / Deficiency Letter
Sunglow Pharmaceuticals Pvt Ltd / 33262, 48680 / Deficiency Letter
Sunglow Pharmaceuticals Pvt Ltd / 33264, 48853 / Deficiency Letter
Sunglow Pharmaceuticals Pvt Ltd / 33267, 48713 / Deficiency Letter

MEDICAL DEVICE

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Bard India Healthcare Pvt. Ltd. / 27311 / Query Letter
M/s. Biomet Orthopaedics India Pvt. Ltd. / 16118 / Query Letter
M/s. Biotronik Medical Devices India Pvt. Ltd. / 18284 / Query Letter
M/s. Hester Diagnostics Pvt. Ltd. / 17301 / Query Letter
M/s. Innovative Therapeutics (P) Ltd. / 32457 / Query Letter
M/s. Johnson & Johnson Ltd. / 29506 / Query Letter
M/s. Kentron Biotechnology Pvt. Ltd. / 25096 / Query Letter
M/s. KCI Medical India Pvt. Ltd. / 26022 / Query Letter
M/s. MN Solutions. / 14836 / Query Letter
M/s. Stryker India Pvt. Ltd. / 14296 / Query Letter
The Deputy Drugs Controller (I), Gujarat / 43464 / Letter
The Deputy Drugs Controller (I), Ghaziabad (CLAA) / Nil / Letter

DIAGNOSTICS DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Biomerieux India Pvt. Ltd. / 29311 / Query Letter
M/s. Kan Health Care. / 30629 / Query Letter
M/s. Trivitron Healthcare Pvt. Ltd. / 30080 / Query Letter
M/s. Vishwa Trading. / 27882 / Query Letter

VACCINE DIVISION

S. No. / COMPANY NAME / Dy.No. / STATUS
1 / M/s Hipra (I) Pvt , ltd / 30114, 30113 / Clarification Letter
2 / M/s Cadila Healthcare Ltd / 32530 / Clarification Letter

NDAC MEETING LETTER

S. No. / COMPANY NAME / Dy.No. / STATUS
1 / M/s Cadila Pharmaceutical Ltd / Invitation Letter
2 / M/s Baxter / Invitation Letter
3 / M/s Cadila Healthcare Ltd / Invitation Letter
4 / M/s Intas Pharmaceutical ltd / Invitation Letter
5 / M/s Roche Product (India) Pvt, ltd / Invitation Letter

IMPORT

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
Ind-Swift Laboratories Limited / 28267 / Approval Letter
Sagar Rubber Products Pvt. Ltd. / 33554 / Approval Letter
Pulse Pharma / 33482 / Approval Letter
Pulse Pharma / 33481 / Approval Letter
Pulse Pharma / 33480 / Approval Letter
Kopran Limited / 33514 / Approval Letter
Micro Labs Ltd. / 33599 / Approval Letter
Kopran Limited / 33513 / Approval Letter
Ketan Pharma, / 33540 / Approval Letter
Farmachem Life Pvt. Ltd. / 33709 / Approval Letter
Uttaranchal Biotech Limited / 33638 / Approval Letter
Abil Chempharma Pvt. Ltd. / 33655 / Approval Letter
Abil Chempharma Pvt. Ltd. / 33654 / Approval Letter
Torrent Pharmaceuticals Ltd. / 33710 / Approval Letter
Emil Pharmaceuticals Industries Pvt. Ltd. / 33924 / Approval Letter
United Biotech Pvt. Ltd. / 33846 / Approval Letter
Zuvius Lifesciences Pvt. Ltd. / 33860 / Approval Letter
Medi Pharma Drug House / 33861 / Approval Letter
Bharat Parenterals Limited / 33922 / Approval Letter
Sentiss Pharma Pvt. Ltd. / 33898 / Approval Letter
Ipca laboratories Limited / 33930 / Approval Letter
Medibios Laboratories Pvt. Ltd. / 33923 / Approval Letter
Abil Chempharma Pvt. Ltd. / 33718 / Approval Letter
J.B. Khokhani & Co. / 33987 / Approval Letter
Bohra Sales & Services Ltd. / 33945 / Approval Letter
Pratistha Pharma / 34317,26597 / 2 Approval Letter
Pfizer Ltd. / 36402 / Clarification Letter
Sun Pharmaceutical Industries Ltd./Anantco Enterprises Pvt. Ltd. / 30362 / Clarification Letter
Kantilal Manilal & Pvt. Ltd. ./Anantco Enterprises Pvt. Ltd. / 32641 / Clarification Letter
Sun Pharma Laboratories Ltd. ./Anantco Enterprises Pvt. Ltd. / 29048 / Clarification Letter
Rumit Lifecare / 30298 / Clarification Letter

REGISTRATION

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
ZOETIS INDIA LTD. / 30000 / Clarification Letter
PFIZER PRODUCTS INDIA PVT. LTD. / 17204 / Clarification Letter
ESSCHEM PVT. LTD. / 21391,26575 / 2 Clarification Letter
B.M. CHEMIE / 21094 / Clarification Letter
PHARMAZELL INDIA PVT. LTD. / 25187 / Clarification Letter
SHAH TC OVERSEASE PVT. LTD. / 10232 / Clarification Letter
UNI-CHEMIE INTERNATIONAL / 18879 / Clarification Letter
ETHACHEM / 21303,21023 / 2 Clarification Letter
G.C. CHEMIE / 23801 / Clarification Letter
ANIKA INTERNATIONAL / 27328 / Clarification Letter
KOLSON INDIA / 32417 / Clarification Letter
UNIMARK REMEDIES LTD. / 19541 / Clarification Letter
ACETO PHARMA / 21799 / Clarification Letter
SANOFI-SYNTHELABO (I) LTD / 20947 / Clarification Letter

BA/BE DIVISION

S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS
01 / M/s. Lambda Therapeutic Research Ltd., Mumbai / 58810 / Approval
02 / M/s. Macleods Pharmaceuticals, Mumbai / 778 / Approval
03 / M/s. Cadila Pharmaceuticals, Ahmadabad / 27652 / Query

MEDICAL DEVICE

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Bard India Healthcare Pvt. Ltd. / 27311 / Query Letter
M/s. Biomet Orthopaedics India Pvt. Ltd. / 16118 / Query Letter
M/s. Biotronik Medical Devices India Pvt. Ltd. / 18284 / Query Letter
M/s. Hester Diagnostics Pvt. Ltd. / 17301 / Query Letter
M/s. Innovative Therapeutics (P) Ltd. / 32457 / Query Letter
M/s. Johnson & Johnson Ltd. / 29506 / Query Letter
M/s. Kentron Biotechnology Pvt. Ltd. / 25096 / Query Letter
M/s. KCI Medical India Pvt. Ltd. / 26022 / Query Letter
M/s. MN Solutions. / 14836 / Query Letter
M/s. Stryker India Pvt. Ltd. / 14296 / Query Letter
The Deputy Drugs Controller (I), Gujarat / 43464 / Letter
The Deputy Drugs Controller (I), Ghaziabad (CLAA) / Nil / Letter

DIAGNOSTICS DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Biomerieux India Pvt. Ltd. / 29311 / Query Letter
M/s. Kan Health Care. / 30629 / Query Letter
M/s.Trivitron Healthcare Pvt. Ltd. / 30080 / Query Letter
M/s. Vishwa Trading. / 27882 / Query Letter
M/s. Euro Diagnostics Systems Pvt. Ltd. / 30480 / Query Letter

GLOBAL CLINICAL TRIAL

Sr. No. / Name of Firm / Reference No. / Type of Letter
1. / M/s. Quintiles / 31610 / Clarification Letter
2. / M/s. Novartis / 31059 / Clarification Letter

COSMETICS DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Star India, Jodhpur / 31399 / Deficiency Letter
M/s. Wockhardt Limited, Mumbai / 27993 / Deficiency Letter

NEW DRUG

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
M/s. Glenmark Pharmaceuticals Ltd. / - / CT NOC Letter (2)
Dr. Kalpagam Polasa / - / Query Letter
Dr. Neena Khanna / - / Query Letter