LETTERS FOR ISSUE ON18.07.2014

REGISTRAITON

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
Dr. Reddy’s Lab Ltd. / 11587 / Clarification letter

SUBSEQUENT NEW DRUG

S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER
M/s Allergan India Pvt. Ltd., / 3459 / - / Deficiency Letter
2. / M/s Dr. Reddy’s Laboratories Ltd., / 2547 / 4101 / Deficiency Letter(2)
3. / M/s NU-Therapeutics Pvt. Ltd., / 19343 / 28763 / Deficiency Letter
4. / M/s Lincoln Pharmaceuticals Ltd., / 64514,18032 / 88553, 26849 / Deficiency Letter
5. / M/s Emcure Pharmaceuticals Ltd., / 17152 / 25695 / Deficiency Letter
6. / M/s Lupin Limited., / 19027 / 28610 / Deficiency Letter
7. / M/s Parker Robinson Pvt. Ltd., / - / 12618 / Deficiency Letter
8. / M/s Therdose Pharma Pvt. Ltd., / 18158 / 27154 / Deficiency Letter
9 / M/s Sun Pharma Advanced Research Company Ltd., / 12985 / 19751 / Deficiency Letter
10. / M/s Vinkem Labs Limited. / - / 16575 / Deficiency Letter
11. / M/s Sun Pharmaceutical Industries Limited., / 45445 / 61751 / Deficiency Letter
12. / M/s Lark Laboratories (India) Ltd., / 8000 / 12004 / Deficiency Letter
13 / M/s Manipal Accunova / - / - / Letter
14 / M/s Cadila Healthcare Ltd., / - / - / Letter
15 / M/s Glenmark Generics Ltd., / - / - / Letter
16 / M/s GSK / - / - / Letter

VACCINE DIVISION

S. No. / COMPANY NAME / Dy.No. / STATUS
1 / M/s Jhonson & Jhonson Ltd / 13376 / Clarification letter
2 / M/s Sovereign Pharma Ltd / 19338 / Clarification letter
3 / M/s Reliance Life Sciences Pvt Ltd / 26436 / Approval letter
4 / M/s Alcon Laboratories (India) Pvt Ltd / 19362 / Approval letter
5 / M/s Paviour Pharmaceuticals / 109 / Amendment letter
6 / M/s GlaxoSmithKline Pharamceuticals Ltd / Approval letter
7 / M/s Fischer Clinical Services / 179955 / Continuation letter

BIOLOGICAL DIVISION

S. No. / COMPANY NAME / Dy.No. / STATUS
1 / M/s USV Ltd / 21776 / Clarification letter
2 / M/s Biocon limited / FTS 16043 / Approval letter
3 / M/S Biological E. Ltd / 24408 / Approval letter

FDC DIVISION

S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT
M/s. Akums Drugs / Nil / NDAC Meeting Letter
M/s. Sun Pharmaceuticals / 17969 / Approval Letter
M/s Intas Pharmaceuticals / 25283 / Amendment Letter

BE NOC FOR EXPORT

S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter
M/s. Actimus Biosciences Pvt. Ltd., Visakhapatnam-530 003 / 24215 / Clarification Letter
M/s. Agila Specialities Pvt. Ltd., Bengaluru-560 076 / 23468 / Clarification Letter
M/s. Alkem Laboratories Ltd., Dist: Raigad -410208 / 23770 / Clarification Letter
M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 16170 / Clarification Letter
M/s. Aristo Pharmaceuticals Pvt. Ltd., Mumbai-400 053 / 23857 / Clarification Letter
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 26350 / Clarification Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 24413 / Clarification Letter
M/s. Famy Care Ltd., Mumbai-400 001 / 22648 / Clarification Letter
M/s. Fortis Clinical Research Ltd., Faridabad-121002 / 26147 / Clarification Letter
M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 23558 / Clarification Letter
M/s. GVK Biosciences Pvt. Ltd., Ahmedabad-380 051 / 25204 / Clarification Letter
M/s. GVK Biosciences Pvt. Ltd., Hyderabad-500 038 / 25976 / Clarification Letter
M/s. Jubilant Life Sciences Limited, Noida-201 301, UP / 23309 / Clarification Letter
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 24801 / Clarification Letter
M/s. Lupin Bioresearch Center, Pune-411 021 / 25369 / Clarification Letter
M/s. RA Chem Pharma Ltd., Balanagar, Hyderabad-500 037 / 25748 / Clarification Letter
M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 24906 / Clarification Letter
M/s. Synchron Research Services Pvt. Ltd., Ahmedabad-380 054 / 24488 / Clarification Letter
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400 614 / 24919 / Clarification Letter
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400 614 / 24918 / Clarification Letter
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400 614 / 25727 / Clarification Letter
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400 614 / 24917 / Clarification Letter

MEDICAL DEVICE

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. India Medtronic Pvt. Ltd. / 22542 / Approval (F-IL)
M/s. Bausch & Lomb Eyecare (India) Pvt. Ltd. / 25100 / Approval (R-E-IL)
M/s. Covidien Healthcare India Pvt. Ltd. / 22983 / Approval Letter
M/s. Abbott Healthcare Pvt. Ltd. / 13791 / Approval Letter
M/s. Boston Scientific India Pvt. Ltd. / 21833 / Approval Letter
M/s. B. Braun Medical India Pvt. Ltd. / 22765 / Approval Letter
M/s. Translumina Therapeutics LLP. / 18585 / Approval Letter
M/s. Depuy Medical Pvt. Ltd.
M/s. Depuy International Limited, UK.
M/s. Europlaz Technologies Ltd., UK.
All port offices of CDSCO. / 36868 / Letter
Office Memorandum
The Deputy Drugs Controller (I), Mumbai
The Deputy Drugs Controller (I), Ahmedabad / 20876 / Letter
M/s. Aalay Surgicals Pvt. Ltd. / 13243 / Query Letter
M/s. Biomet Orthopaedics India Pvt. Ltd. / 10261 / Query Letter
M/s. Bard India Healthcare Pvt. Ltd. / 18764 / Query Letter
M/s. Clairvoyance Consulting. / 21396 / Query Letter
M/s. Coherent Medical Systems. / 11048 / Query Letter
M/s. Covidien Healthcare India Pvt. Ltd. / 22981 / Query Letter
M/s. Emergo (I) Consulting Pvt. Ltd. / 10537 / Query Letter
M/s. KCI Medical India Pvt. Ltd. / 12766 / Query Letter
M/s. Life Care Devices Pvt. Ltd. / 9806 / Query Letter
M/s. Piramal Healthcare Ltd. / 27982 / Query Letter
M/s. Medtronic India Pvt. Ltd.
All Zonal/ Sub Zonal/Port Offices of CDSCO / 37829 / Letter
The Joint Commissioner (K.D), Thane (CLAA)
M/s. Suru International Pvt. Ltd. / 25216 / Query Letter
The Director of Drugs Control, Chennai (CLAA)
The Deputy Drugs Controller (I), Chennai (CLAA)
(M/s. TTK Healthcare Limited) / FTS-22953 / Letter

DIAGNOSTIC DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Werfen Medical India Pvt. Ltd. / 20635 / Approval (E-RC)
M/s. Beckman Coulter India Pvt. Ltd. / 21544 / Approval (IL)
M/s. SD Biostandard Diagnostics Pvt. Ltd. / 18942 / Approval (IL)
M/s. Transasia Bio Medicals Ltd. / 21902 / Approval (IL)
M/s. Alere Medical Pvt. Ltd. / 23043 / Approval Letter
M/s. SD Biostandard Diagnostics Pvt. Ltd. / 18942 / Query Letter
M/s. Arkray Healthcare Pvt. Ltd. / 23349 / Query Letter
M/s. Novo Healthcare Ltd. / 22621 / Query Letter
M/s. Venus Medical Technologies. / 23867 / Query Letter
M/s. Meril Diagnostics Pvt. Ltd. / 22844 / Letter
M/s. Meril Diagnostics Pvt. Ltd. / 21988 / Letter

TEST LICENCES

S. No. / Name of the Company / Diary No. / Type of Letter
Actavis Pharma Development Centre Pvt. Ltd / 27566, 40553 / Approval Letter
Actavis Pharma Development Centre Pvt. Ltd / 27907, 41110 / Approval Letter
Actavis Pharma Development Centre Pvt. Ltd / 27906, 41105 / Approval Letter
Agila Specialties Pvt. Ltd / 27887, 40930 / Approval Letter
Agila Specialties Pvt. Ltd / 27893, 40951 / Approval Letter
Aizant Drug Research Solutions Pvt. Ltd / 27654, 40888 / Approval Letter
Ajanta Pharma Ltd / 27464, 40638 / Approval Letter
Ajanta Pharma Ltd / 27465, 40636 / Approval Letter
Ajanta Pharma Ltd / 27466, 40634 / Approval Letter
Ajanta Pharma Ltd / 27467, 40630 / Approval Letter
Ajanta Pharma Ltd / 27468, 40628 / Approval Letter
Ajanta Pharma Ltd / 27469, 40627 / Approval Letter
Ajanta Pharma Ltd / 27470, 40624 / Approval Letter
Ajanta Pharma Ltd / 27471, 40622 / Approval Letter
Alkem Laboratories Ltd / 27715, 40939 / Approval Letter
APL Research Centre / 27835, 41125 / Approval Letter
APL Research Centre / 27836, 41127 / Approval Letter
APL Research Centre / 27837, 41140 / Approval Letter
APL Research Centre / 27838, 41137 / Approval Letter
APL Research Centre / 27840, 41133 / Approval Letter
APL Research Centre / 27839, 41130 / Approval Letter
APL Research Centre / 27841, 41147 / Approval Letter
APL Research Centre / 27842, 41144 / Approval Letter
Apotex Research Pvt. Ltd / 27674, 41034 / Approval Letter
Apotex Research Pvt. Ltd / 27675, 41030 / Approval Letter
Apotex Research Pvt. Ltd / 27676, 41028 / Approval Letter
Apotex Research Pvt. Ltd / 27677, 41023 / Approval Letter
Apotex Research Pvt. Ltd / 27673, 41083 / Approval Letter
Apotex Research Pvt. Ltd / 27678, 41081 / Approval Letter
Apotex Research Pvt. Ltd / 27685, 40995 / Approval Letter
Apotex Research Pvt. Ltd / 27686, 40997 / Approval Letter
Apotex Research Pvt. Ltd / 27687, 41001 / Approval Letter
Apotex Research Pvt. Ltd / 27688, 41006 / Approval Letter
Apotex Research Pvt. Ltd / 27689, 41010 / Approval Letter
Apotex Research Pvt. Ltd / 27690, 41022 / Approval Letter
Apotex Research Pvt. Ltd / 27691, 41018 / Approval Letter
Apotex Research Pvt. Ltd / 27692, 41017 / Approval Letter
Apotex Research Pvt. Ltd. / 27670, 41079 / Approval Letter
Apotex Research Pvt. Ltd. / 27671, 41077 / Approval Letter
Apotex Research Pvt. Ltd. / 27672, 41074 / Approval Letter
Cadila Healthcare Limited / 27378, 40236 / Approval Letter
Cadila Healthcare Limited / 27379, 40238 / Approval Letter
Cadila Healthcare Limited / 27380, 40240 / Approval Letter
Cadila Healthcare Limited / 27381, 40243 / Approval Letter
Cadila Healthcare Limited / 27382, 40244 / Approval Letter
Cadila Healthcare Limited / 27861, 40933 / Approval Letter
Cipla Ltd / 27325, 40341 / Approval Letter
Cipla Ltd / 27326, 40338 / Approval Letter
Dr. Reddy’s Laboratories Ltd / 27484, 40580 / Approval Letter
Dr. Reddy’s Laboratories Ltd / 27269, 40198 / Approval Letter
Dr. Reddy’s Laboratories Ltd / 27488, 40577 / Approval Letter
Dr. Reddy’s Laboratories Ltd / 27506, 40595 / Approval Letter
Dr. Reddy’s Laboratories Ltd / 27752, 40971 / Approval Letter
Dr. Reddy’s Laboratories Ltd / 27749, 40973 / Approval Letter
Dr. Reddy’s Laboratories Ltd / 27753, 40976 / Approval Letter
Dr. Reddy’s Laboratories Ltd / 27750, 40977 / Approval Letter
Dr. Reddy’s Laboratories Ltd / 27751, 40979 / Approval Letter
Emcure Pharmaceuticals Ltd / 27461, 40646 / Approval Letter
Emcure Pharmaceuticals Ltd / 27462, 40645 / Approval Letter
Emcure Pharmaceuticals Ltd / 27462, 40642 / Approval Letter
Emcure Pharmaceuticals Ltd / 27655, 40910 / Approval Letter
Getz Pharma Research Pvt. Ltd / 27477, 40571 / Approval Letter
Getz Pharma Research Pvt. Ltd / 27478, 40566 / Approval Letter
Getz Pharma Research Pvt. Ltd / 27479, 40562 / Approval Letter
Gland Pharma Ltd / 27800, 40966 / Approval Letter
Gland Pharma Ltd / 27797, 40957 / Approval Letter
Gland Pharma Ltd / 27798, 40954 / Approval Letter
Gland Pharma Ltd / 27999, 40964 / Approval Letter
Gland Pharma Ltd / 27801, 40969 / Approval Letter
Gland Pharma Ltd / 27802, 40963 / Approval Letter
Glenmark Generics Ltd / 27804, 41114 / Approval Letter
Glenmark Generics Ltd / 27803, 41120 / Approval Letter
Glenmark Generics Ltd / 27805, 41118 / Approval Letter
Glenmark Generics Ltd / 28018, 41339 / Approval Letter
Glenmark Pharmaceuticals Ltd / 28029, 41338 / Approval Letter
Hetero Labs Ltd / 27714, 40898 / Approval Letter
Hospira Healthcare India Pvt. Ltd / 27894, 41086 / Approval Letter
Indoco Remedies Ltd / 27570, 40678 / Approval Letter
Indoco Remedies Ltd / 27571, 40677 / Approval Letter
Indoco Remedies Ltd / 27572, 40676 / Approval Letter
Indoco Remedies Ltd / 27573, 40674 / Approval Letter
Indoco Remedies Ltd / 27578, 40673 / Approval Letter
Johnson and Johnson Ltd / 27565, 40671 / Approval Letter
Johnson and Johnson Ltd / 27820, 40937 / Approval Letter
Johnson and Johnson Ltd / 27821, 40936 / Approval Letter
Lupin Ltd / 27567, 40547 / Approval Letter
Lupin Ltd / 27568, 40681 / Approval Letter
Lupin Ltd / 27569, 40680 / Approval Letter
Lupin Ltd / 27734, 40941 / Approval Letter
Macleods Pharmaceuticals Ltd / 27589, 40552 / Approval Letter
Onco Therapies Ltd / 27891, 40986 / Approval Letter
Onco Therapies Ltd / 27890, 70992 / Approval Letter
Onco Therapies Ltd / 27888, 40985 / Approval Letter
Onco Therapies Ltd / 27889, 40982 / Approval Letter
Onco Therapies Ltd / 27892, 40990 / Approval Letter
Onco Therapies Ltd / 27957, 41232 / Approval Letter
Orbit Lifescience Pvt. Ltd / 27232, 40362 / Approval Letter
Organon (India) Pvt Ltd. / 27376, 40195 / Approval Letter
Perrigo Laboratories India Pvt Ltd / 27563, 40590 / Approval Letter
Piramal Enterprises Ltd / 24989, 36706 / Approval Letter
Sanofi-Synthelabo (India) Ltd / 27440, 40363 / Approval Letter
Sanofi-Synthelabo (India) Ltd / 27592, 40695 / Approval Letter
SGS India Pvt. Ltd / 27903, 41095 / Approval Letter
SGS India Pvt. Ltd / 27904, 41099 / Approval Letter
SGS India Pvt. Ltd / 27905, 41100 / Approval Letter
Sharon Bio-Medicine Ltd / 27489, 40617 / Approval Letter
Sun Pharmaceutical Industries Ltd / 27502, 40614 / Approval Letter
Sun Pharmaceutical Industries Ltd / 27504, 40611 / Approval Letter
Sun Pharmaceutical Industries Ltd / 27505, 40607 / Approval Letter
Tevapharm India Private limited / 27401, 40221 / Approval Letter
Tevapharm India Private limited / 27402, 40224 / Approval Letter
Tevapharm India Private limited / 27403, 40227 / Approval Letter
Tevapharm India Private limited / 27404, 40229 / Approval Letter
Tevapharm India Private limited / 27405, 40231 / Approval Letter
Tevapharm India Private limited / 27406, 40234 / Approval Letter
Tevapharm India Private limited / 27400, 40219 / Approval Letter
Tevapharm India Pvt. Ltd / 27397, 40202 / Approval Letter
Tevapharm India Pvt. Ltd / 27398, 40209 / Approval Letter
Tevapharm India Pvt. Ltd / 27399, 40215 / Approval Letter
Torrent Pharmaceuticals Ltd / 27712, 40872 / Approval Letter
Torrent Pharmaceuticals Ltd / 27713, 40867 / Approval Letter
Unijules Life Sciences Ltd / 27414, 40360 / Approval Letter
Unique Pharmaceutical Laboratories / 27693, 40828 / Approval Letter
V-ensure Pharma Technologies Pvt. Ltd. / 27962, 41238 / Approval Letter
VerGo Pharma Research Laboratories Pvt Ltd / 27669, 40858 / Approval Letter
Apotex Research Pvt Ltd / 27679, 41040, 27680, 41038 / Deficiency Letter
Emcure Pharmaceuticals Ltd / 24716, 36588 / Deficiency Letter
Emcure Pharmaceuticals Ltd / 24711, 35687 / Deficiency Letter
Enem Nostrum Remedies Pvt Ltd / 24313, 35891 / Deficiency Letter
Epsilon Pharmaceuticals Pvt Ltd / 276334 to 27640 / Deficiency Letter
Getz Pharma Research Pvt Ltd / 27476, 40558 / Deficiency Letter
Hospira Healthcare India Pvt Ltd / 27109, 39967 / Deficiency Letter
Ipca Laboratories Ltd / 24609, 36403 / Deficiency Letter
Jubilant Life Sciences Ltd / 27019, 39745 / Deficiency Letter
KMS Health Center Pvt Ltd / 27656, 40879 / Deficiency Letter
MSN Laboratories Ltd / 26904, 39571 / Deficiency Letter
Mylan Laboratories Ltd / 27255, 40290 / Deficiency Letter
Perrigo Laboratories India Pvt Ltd / 27564, 40584 / Deficiency Letter
Syngene International Ltd / 26855, 39640 / Deficiency Letter
Umedica Laboratories Pvt Ltd / 27303, 40263 / Deficiency Letter
Zoetis Pharmaceutical Research Pvt Ltd / 25719, 37702, 25720, 37700, 25722, 37696 / Deficiency Letter

COSMETICS DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Croda India Company Private Limited, Mumbai / 20192 / Deficiency Letter
M/s. Mingfai Quality amenities(I) Pvt. Ltd, New Delhi / 19090 / Deficiency Letter
M/s. Sephora Cosmetics Pvt. Ltd, New Delhi / 23271 / Approval letter
M/s. JCKRC Spa Destination Pvt. Ltd, Mumbai / 20830 / Approval Letter
M/s. Ethicare Remedies, Gujarat / 30584 / Approval Letter
M/s. Everstyle Hotel Supplies India Pvt. Ltd, Haryana / 22221 / Approval Letter

GLOBAL CLINICAL TRIAL

Sr. No. / Name of Firm / Reference No. / Type of Letter
1. / M/s. Eli Lilly / 22931 / Amendment in TL Approval/NDAC Follow up Letter
2. / M/s. Roche / - / NDAC Follow Up Letter
3. / M/s. Novo Nordisk / - / NDAC Follow Up Letter
4. / M/s. INC Research / - / NDAC Follow Up Letter
5. / M/s. Pfizer / - / NDAC Follow Up Letter
6. / M/s. Watson / - / NDAC Follow Up Letter
7. / M/s. Max neeman / 62045 / PA Approval/Export NOC/TL Approval letters
8. / M/s. Novartis / 22832/21064/4544/23532 / PA & New Sites Approval
9. / M/s. Johnson & Johnson / 54764/55583/16627 / Change in PI & Change in site Address Approval
10. / M/s. Cliantha / - / NDAC Follow Up Letter