LETTERS FOR ISSUE ON01.08.2014
LVP DIVISION
S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS01 / M/s. Claris Lifesciences C/o M/s. Claris Otsuka, Gujarat / 43187 / Approval
02 / M/s. Claris Lifesciences, Gujarat / 34634 / Approval
03 / M/s. Gland Pharma Ltd., Hyderabad / 42642 / Query
04 / M/s. Denis Chem Lab, Gandhinagar / 38761 / Query
05 / M/s. Unique Pharma, Gujarat / 40701 / Approval
06 / M/s. Bion Healthcare C/o M/s. Eurolife Healthcare Pvt. Ltd., Uttarakhand / 42636 / Query
07 / M/s. Lincoln C/o Shri Krishna Keshav Lab, Gujarat / 20369 / Query
BA/BE DIVISION
S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS01 / M/s. Axis Clinical Ltd., Hyderabad / 16037 / 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 / 29087 / Approval Letter
M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 29297 / Approval Letter
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 17274 / Approval Letter
M/s. Axis Clinical Ltd., Hyderabad-500 049 / 27026 / Clarification Letter
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 29033 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 29062 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 29419 / Approval Letter
M/s. Dr. Reddy’s Laboratories Ltd., Hyderabad-500 034 / 27421 / Approval Letter
M/s. Dr. Reddy’s Laboratories Ltd., Hyderabad-500 034 / 27420 / Approval Letter
M/s. Dr. Reddy’s Laboratories Ltd., Hyderabad-500 034 / 30065 / Approval Letter
M/s. GVK Biosciences Pvt. Ltd., Ahmedabad-380 051 / 28617 / Approval Letter
M/s. GVK Biosciences Pvt. Ltd., Hyderabad-500 038 / 29334 / Approval Letter
M/s. GVK Biosciences Pvt. Ltd., Hyderabad-500 038 / 29340 / Approval Letter
M/s. Inventia Healthcare Pvt. Ltd., Dist. Thane-421 506 / 19528 / Approval Letter
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 29123 / Approval Letter
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 26548 / Clarification Letter
M/s. Lupin Bioresearch Center, Pune-411 021 / 27859 / Clarification Letter
M/s. Lupin Bioresearch Center, Pune-411 021 / 17177 / Approval Letter
M/s. Lupin Bioresearch Center, Pune-411 021 / 14381 / Approval Letter
M/s. Lupin Bioresearch Center, Pune-411 021 / 17211 / Approval Letter
M/s. Lupin Bioresearch Center, Pune-411 021 / 30094 / Approval Letter
M/s. Mankind Pharma Limited, Himachal Pradesh / 23809 / Clarification Letter
M/s. Micro Therapeutic Research Labs Pvt. Ltd., Coimbatore-641029 / 17576 / Approval Letter
M/s. MSN Laboratories Pvt. Ltd., Andhra Pradesh-502 325 / 30472 / Approval Letter
M/s. Norwich Clinical Services Pvt. Ltd., Bangalore-560 034 / 29992 / Approval Letter
M/s. Ranbaxy Laboratories Ltd., Gurgaon-122 015 / 28118 / Clarification Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 23779 / Amendment Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 23778 / Amendment Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 14284 / Approval Letter
M/s. Vimta Labs Ltd., Hyderabad-500051 / 29198 / Approval Letter
M/s. Watson Pharma Pvt Ltd., Navi Mumbai-400614 / 29196 / Approval Letter
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400 614 / 22365 / Clarification Letter
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400 614 / 26419 / Clarification Letter
ONLY TEST LICENCE FOR BE
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letterM/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 16074 / Test Licence
M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 29844 / Test Licence
M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 29858 / Test Licence
M/s. GVK Biosciences Pvt. Ltd., Ahmedabad-380 051 / 28554 / Test Licence
M/s. Kusum Healthcare Pvt. Ltd., New Delhi-110 020 / 29540 / Test Licence
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 29613 / Test Licence
M/s. Torrent Pharmaceuticals Ltd. (Research Centre), Gujarat / 29685 / Test Licence
M/s. Watson Pharma Pvt Ltd., Navi Mumbai-400614 / 26322 / Test Licence
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUSM/s. Ypsomed India Pvt. Ltd. / FTS-44718 / Query Letter
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENTM/s. Insat Pharma / 41953 / Letter
M/s. Adcock Ingram Healthcare Pvt. Ltd., / 2195 / Letter
M/s. Gopaldas Vishram & Co. Ltd., / 685 / Clarification Letter
M/s. Gopaldas Vishram & Co. Ltd., / 688 / Clarification Letter
M/s. Pfizer Ltd., / 25050 / Letter
M/s. Akums Drugs & Pharmaceuticals Ltd., / 42785 / Clarification Letter
M/s. Serin Formulations Pvt. Ltd., / 44300 / Clarification Letter
M/s. Darwin Formulations Pvt. Ltd., / 45497 / Clarification Letter
M/s. Gurufcure, / 41941 / Clarification Letter
M/s. Crescent Labs Pvt. Ltd., / 38924 / Letter
M/s. Crescent Labs Pvt. Ltd., / 38944 / Letter
M/s. Provini Animal Nutrition India (P) Ltd., / 25051 / Clarification Letter
M/s. Optho Remedies Pvt.Ltd., / 29013 / Clarification Letter
M/s. Santo Formulations / 44307 / Clarification Letter
M/s. Alchemist Ltd., / 20261 / Clarification Letter
M/s. Vivek Pharmachem India Ltd., / 46770 / Letter
M/s. Theon Pharmaceuticals Ltd., / 26495 / Letter
M/s. Sayora Pharma Pvt. Ltd., / 42114 / Clarification Letter
M/s. Safetab Life Sciences / 42645 / Letter
M/s. Suraksha Pharma Pvt.Ltd. / 43645 / Clarification Letter
M/s. Acron Pharmaceuticals, / 41676 / Clarification Letter
TEST LICENCES
S. No. / Name of the Company / Diary No. / Type of LetterAgila Specialties Pvt. Ltd / 30118, 44427 / Approval Letter
Aizant Drug Research Solutions Pvt Ltd / 30331, 44763 / Approval Letter
Alembic Pharmaceuticals Ltd / 30200, 44495 / Approval Letter
APL Research Centre / 30030, 44348 / Approval Letter
APL Research Centre / 30031, 44346 / Approval Letter
APL Research Centre / 30032, 44337 / Approval Letter
APL Research Centre / 30033, 44323 / Approval Letter
APL Research Centre / 30034, 44314 / Approval Letter
APL Research Centre / 30035, 44310 / Approval Letter
Apotex Research Pvt. Ltd / 30136, 44423 / Approval Letter
Apotex Research Pvt. Ltd / 30140, 44425 / Approval Letter
Apotex Research Pvt. Ltd / 30141, 44533 / Approval Letter
Apotex Research Pvt. Ltd / 30142, 44529 / Approval Letter
Apotex Research Pvt. Ltd / 30143, 44524 / Approval Letter
Apotex Research Pvt. Ltd / 30144, 44514 / Approval Letter
Apotex Research Pvt. Ltd / 30145, 44506 / Approval Letter
Apotex Research Pvt. Ltd / 30146, 44505 / Approval Letter
Apotex Research Pvt. Ltd / 30147, 44489 / Approval Letter
Apotex Research Pvt. Ltd / 30148, 44492 / Approval Letter
Apotex Research Pvt. Ltd / 30149, 44539 / Approval Letter
Apotex Research Pvt. Ltd / 30150, 44542 / Approval Letter
Apotex Research Pvt. Ltd / 30151, 44547 / Approval Letter
Apotex Research Pvt. Ltd / 30152, 44553 / Approval Letter
Apotex Research Pvt. Ltd / 30153, 44942 / Approval Letter
Cadila Healthcare Ltd / 30244, 44450 / Approval Letter
Cadila Healthcare Ltd. / 30003, 44356 / Approval Letter
Cadila Healthcare Ltd. / 30004, 44352 / Approval Letter
Cipla Ltd / 29969, 44286 / Approval Letter
Cipla Ltd / 29970, 44284 / Approval Letter
Cipla Ltd / 29971, 44281 / Approval Letter
Cipla Ltd / 29972, 44277 / Approval Letter
Cipla Ltd / 29973, 44279 / Approval Letter
Cipla Ltd / 29974, 44369 / Approval Letter
Cipla Ltd / 29975, 44368 / Approval Letter
Cipla Ltd / 29976, 44367 / Approval Letter
Cipla Ltd / 29977, 44368 / Approval Letter
Cipla Ltd / 29978, 44363 / Approval Letter
Cipla Ltd / 29979, 44359 / Approval Letter
Cipla Ltd / 30346, 44834 / Approval Letter
Cipla Ltd / 30347, 44831 / Approval Letter
Cipla Ltd / 30348, 44824 / Approval Letter
Cipla Ltd / 30349, 44819 / Approval Letter
Cipla Ltd / 30350, 44813 / Approval Letter
Cipla Ltd / 30351, 44807 / Approval Letter
Cipla Ltd / 30352, 44803 / Approval Letter
Cipla Ltd / 30353, 44801 / Approval Letter
Dr. Reddy’s Laboratories Ltd / 30245, 44442 / Approval Letter
Glenmark Pharmaceuticals Ltd / 30239, 44483 / Approval Letter
Glenmark Pharmaceuticals Ltd / 30240, 44471 / Approval Letter
Glenmark Pharmaceuticals Ltd / 30243, 44454 / Approval Letter
Glenmark Pharmaceuticals Ltd / 30246, 44438 / Approval Letter
Inventia Healthcare Pvt. Ltd / 29881, 44248 / Approval Letter
Inventia Healthcare Pvt. Ltd / 29882, 44252 / Approval Letter
Lupin Ltd / 29967, 44308 / Approval Letter
Lupin Ltd / 30184, 44575 / Approval Letter
Lupin Ltd / 30186, 44578 / Approval Letter
Lupin Ltd / 30187, 44580 / Approval Letter
Lupin Ltd / 30188, 44583 / Approval Letter
Lupin Ltd / 30189, 44585 / Approval Letter
Micro Labs Ltd / 30193, 44587 / Approval Letter
Micro Labs Ltd / 30194, 44588 / Approval Letter
Micro Labs Ltd / 30195, 44591 / Approval Letter
Micro Labs Ltd / 30196, 44593 / Approval Letter
Micro Labs Ltd / 30197, 44594 / Approval Letter
Micro Labs Ltd / 30198, 44596 / Approval Letter
Mylan Laboratories Ltd / 30156, 44940 / Approval Letter
Mylan Laboratories Ltd / 30157, 44941 / Approval Letter
Novartis Healthcare Pvt Ltd / 29883, 44261 / Approval Letter
Novartis Healthcare Pvt Ltd / 30216, 44933 / Approval Letter
Novartis Healthcare Pvt Ltd / 30217, 44932 / Approval Letter
Novartis Healthcare Pvt Ltd / 30218, 44934 / Approval Letter
Novartis Healthcare Pvt Ltd / 30219, 44931 / Approval Letter
Novartis Healthcare Pvt Ltd / 30220, 44930 / Approval Letter
Novartis Healthcare Pvt Ltd / 30221, 44929 / Approval Letter
Novartis Healthcare Pvt Ltd / 30223, 44924 / Approval Letter
Novartis Healthcare Pvt Ltd / 30222, 44926 / Approval Letter
Onco Therapies Ltd / 30117, 44433 / Approval Letter
Raptim Research Ltd / 30161, 44938 / Approval Letter
Semler Research Centre Pvt. Ltd / 30199, 44598 / Approval Letter
Sun Pharma Advanced Research Company Ltd / 30350-A, 44780 / Approval Letter
Sun Pharmaceutical Industries Ltd / 30349, 44771 / Approval Letter
Sun Pharmaceuticals Ltd / 30348, 44768 / Approval Letter
Syngene International Limited / 30133, 44402 / Approval Letter
Syngene International Limited / 30134, 44935 / Approval Letter
Syngene International Limited / 30135, 44406 / Approval Letter
Torrent Pharmaceuticals Ltd / 30305, 44886 / Approval Letter
Torrent Pharmaceuticals Ltd / 30306, 44892 / Approval Letter
Torrent Pharmaceuticals Ltd / 30307, 44895 / Approval Letter
USV Ltd / 30330, 44720 / Approval Letter
Watson Pharma Pvt. Ltd / 30159, 44939 / Approval Letter
Wintac Limited / 30154, 44412 / Approval Letter
Wintac Limited / 30155, 44409 / Approval Letter
Dr. Reddy’s Laboratories Ltd / 24094, 35606 / Deficiency Letter
Getz Pharma Research Pvt Ltd / 29595, 43913 / Deficiency Letter
Indoco Remedies Ltd / 29715 43704, 29712, 43809, 29714, 43703 / Deficiency Letter
Johnson and Johnson Ltd / 29916, 44224, 29917, 44225 / Deficiency Letter
Jubilant Generics Ltd / 29626, 43698 / Deficiency Letter
Jubilant Generics Ltd / 29351 to 29354, 29356 / Deficiency Letter
Jubilant Generics Ltd / 29355, 43301, 29929, 44377 / Deficiency Letter
Jubilant Life Sciences Ltd / 28056, 41269 / Deficiency Letter
Lupin Ltd / 28513, 42100 / Deficiency Letter
MSN Laboratories Pvt Ltd / 28856, 42852 / Deficiency Letter
Sequent Research Ltd / 29607, 43887, 29609, 43896 / Deficiency Letter
SGS India Pvt Ltd / 28672, 42429 / Deficiency Letter
Sitec Labs Pvt Ltd / 27941, 41307 / Deficiency Letter
Stabicon Sciences Pvt Ltd / 30410, 44714 / Deficiency Letter
Vimta Labs Ltd / 29474, 43497, 29663, 43705 / Deficiency Letter
Vimta Labs Ltd / 28825, 42699 / Deficiency Letter
Wockhardt Ltd / 30308, 44712 / Deficiency Letter
Zoetis Pharmaceutical Research Pvt Ltd / 28669, 42831 / Deficiency Letter
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTERM/s Athena Drugs ltd. / 26163 / - / letter