LETTERS FOR ISSUE ON10.09.2014
LVP DIVISION
S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS01 / M/s. Ives Drugs (I), M.P. / 43821 / Approval
02 / M/s. Glenmark Pharmaceuticals, C/o. M/s. Marck Biosciences, Gujarat / 49641 / Approval
BA/BE DIVISION
S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS01 / M/s. Quest Life Sciences, Chennai / 54467 / Query
02 / M/s. Vimta Labs Ltd., Hyderabad / 18395 / Approval
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letterM/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 34877 / Clarification Letter
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 34878 / Clarification Letter
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 34867 / Approval Letter
M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 35692 / Approval Letter
M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 34460 / Approval Letter
M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 35691 / Approval Letter
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 35183 / Approval Letter
M/s. Axis Clinical Ltd., Hyderabad-500 049 / 35180 / Clarification Letter
M/s. Axis Clinical Ltd., Hyderabad-500 049 / 35253 / Clarification Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 35835 / Clarification Letter
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 35781 / Clarification Letter
M/s. Lupin Bioresearch Center, Pune-411 021 / 35697 / Approval Letter
M/s. Lupin Bioresearch Center, Pune-411 021 / 35696 / Approval Letter
M/s. Micro Therapeutic Research Labs Pvt. Ltd., Chennai-600 059 / 34937 / Approval Letter
M/s. Raptim Research Ltd., Navi Mumbai-400 701 / 34495 / Approval Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 32854 / Clarification Letter
ONLY TEST LICENCE FOR BE
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letterM/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 32882 / Test Licecne
M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 23170 / Test Licecne
VACCINE DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s Lupin Ltd / 30168 / Clarification Letter
2 / M/s GSK / Clarification Letter
3 / M/s L.G. Life Sciences India Pvt, ltd / Clarification Letter
BIOLOGICAL DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s Indian Immunological Ltd / 36046 / Approval Letter
EXPORT OF BIOLOGICAL SAMPLES
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s GVK Bioscience Pvt ,ltd / 34313, 34312, 30336 / Approval Letter
2 / M/s Cliantha Research ltd / 32642, 31249, 31561 / Approval Letter
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTERM/s Cadila Pharmaceuticals / 26562 / 39624 / Deficiency Letter
M/s Intas Pharmaceuticals / 25915 / 38463 / Deficiency Letter
M/s Optimus Drugs Pvt. Ltd. / 17853 / 26439 / Deficiency Letter
M/s Apothecaries Private Ltd. / 23254 / 34550 / Deficiency Letter
M/s Hetero Labs Ltd. / 27115 / 39997 / Deficiency Letter
M/s Shilpa Medicare Ltd. / 27682 / 41160 / Deficiency Letter
M/s Zuventus Healthcare Ltd. / 21541 / 32056 / Deficiency Letter
M/s Inventia healthcare / 25652 / - / Deficiency Letter
M/s Strides Arcolab Ltd. / 24902 / 36776 / Deficiency Letter
M/s Torrent Pharmaceuticals / 25007 / 36784 / Deficiency Letter
M/s Troikaa Pharmaceuticals / 25254, 23373 / 37466, 34635 / Deficiency Letter (2)
M/s Sun Pharma / 26492, 31407 / 39086 / Deficiency Letter (2)
M/s Panacea Biotec Ltd. / 24763 / 36461 / Deficiency Letter
M/s Lupin / - / - / SEC Letter
M/s MSD / - / - / SEC Letter
Dr. Reddy / - / - / SEC Letter
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENTM/s. Parnax Labs Ltd., / 42275 / Clarification Letter
M/s. Akums Drugs & Pharmaceuticals Ltd., / 29042 / Clarification Letter
M/s. Siemen Laboratories (India), / 50094 / Letter
M/s. AGIO Pharmaceuticals Ltd., / 41701 / Clarification Letter
M/s. Synokem Pharmaceuticals Pvt. Ltd., / 41810 / Clarification Letter
M/s. Agron Remedies Pvt. Ltd., / 47310 / Clarification Letter
M/s. Gurufcure, / 43724 / Clarification Letter
M/s. Windlas Healthcare Pvt. Ltd., / 44019 / Letter
M/s. Emcure Pharmaceuticals Ltd., / Nil / NDAC Letter