Letters for Issue On02.07.2014

LETTERS FOR ISSUE ON02.07.2014

TEST LICENCES

S. No. / Name of the Company / Diary No. / Type of Letter
Actavis Pharma Development Centre Pvt. Ltd / 24217, 35822 / Approval Letter
Actavis Pharma Development Centre Pvt. Ltd / 24218, 35827 / Approval Letter
Alembic Pharmaceuticals Ltd / 24059, 35565 / Approval Letter
Alembic Pharmaceuticals Ltd / 24061, 35570 / Approval Letter
Alembic Pharmaceuticals Ltd / 24062, 35580 / Approval Letter
Alembic Pharmaceuticals Ltd / 24063, 35578 / Approval Letter
Alembic Pharmaceuticals Ltd / 24064, 35607 / Approval Letter
Alembic Pharmaceuticals Ltd / 24065, 35604 / Approval Letter
Alembic Pharmaceuticals Ltd / 24066, 35600 / Approval Letter
Alembic Pharmaceuticals Ltd / 24076, 35597 / Approval Letter
Alembic Pharmaceuticals Ltd / 24077, 35595 / Approval Letter
Alembic Pharmaceuticals Ltd / 24078, 35592 / Approval Letter
Alembic Pharmaceuticals Ltd / 24079, 35588 / Approval Letter
Alembic Pharmaceuticals Ltd / 24080, 35583 / Approval Letter
Alphamed Formulations Pvt. Ltd / 24029, 35696 / Approval Letter
Alphamed Formulations Pvt. Ltd / 24030, 35653 / Approval Letter
Apotex Research Pvt. Ltd / 24031, 35652 / Approval Letter
Cadila Healthcare Limited / 24204, 35903 / Approval Letter
Cadila Healthcare Limited / 24205, 35905 / Approval Letter
Cadila Healthcare Limited / 24206, 35909 / Approval Letter
Cadila Healthcare Limited / 24207, 35910 / Approval Letter
Cadila Healthcare Limited / 24208, 35911 / Approval Letter
Centaur Pharmaceuticals Pvt. Ltd / 24097, 35702 / Approval Letter
Getz Pharma Research Pvt. Ltd / 24179, 35852 / Approval Letter
Getz Pharma Research Pvt. Ltd / 24180, 35856 / Approval Letter
Getz Pharma Research Pvt. Ltd / 24181, 35859 / Approval Letter
Getz Pharma Research Pvt. Ltd / 24182, 35861 / Approval Letter
Getz Pharma Research Pvt. Ltd / 24183, 35863 / Approval Letter
Johnson and Johnson Ltd / 24231, 35919 / Approval Letter
Perrigo Laboratories India Pvt Ltd / 24156, 35661 / Approval Letter
Perrigo Laboratories India Pvt Ltd / 24160, 35621 / Approval Letter
Perrigo Laboratories India Pvt Ltd / 24161, 35618 / Approval Letter
Perrigo Laboratories India Pvt Ltd / 24252, 35834 / Approval Letter
Ranbaxy Laboratories Ltd / 24109, 35582 / Approval Letter
Ranbaxy Laboratories Ltd / 24110, 35581 / Approval Letter
Ranbaxy Laboratories Ltd / 24111, 35575 / Approval Letter
Ranbaxy Laboratories Ltd / 24112, 35568 / Approval Letter
Ranbaxy Laboratories Ltd / 24121, 35564 / Approval Letter
Ranbaxy Laboratories Ltd / 24122, 35562 / Approval Letter
Ranbaxy Laboratories Ltd / 24123, 35557 / Approval Letter
Ranbaxy Laboratories Ltd / 24124, 35586 / Approval Letter
Ranbaxy Laboratories Ltd / 24254, 35837 / Approval Letter
Ranbaxy Laboratories Ltd / 24255, 35841 / Approval Letter
Ranbaxy Laboratories Ltd / 24256, 35844 / Approval Letter
Ranbaxy Laboratories Ltd / 24257, 35917 / Approval Letter
Ranbaxy Laboratories Ltd / 24258, 35914 / Approval Letter
Sun Pharmaceutical Industries Ltd / 24185, 35865 / Approval Letter
Sun Pharmaceutical Industries Ltd / 24186, 35768 / Approval Letter
Watson Pharma Pvt Ltd / 24208, 35795 / Approval Letter
Zoetis Pharmaceutical Research Pvt Ltd / 24095, 35602 / Approval Letter
Sr. No / Firm Name / Letter
1. / M/s. Glenmark Generics Ltd., / WC Letter

WRITTEN CONFIRMATION

BE NOC FOR EXPORT

S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter
M/s. Famy Care Ltd., Mumbai-400 001 / 22637 / Clarification Letter
M/s. Manipal Acunova Ltd., Manipal-576 104 / 22324 / Clarification Letter
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400 614 / 13477 / Clarification Letter

VACCINE DIVISION

S. No. / COMPANY NAME / Dy.No. / STATUS
1 / M/s Zenotech Laboratories ltd / Clarification Letter
2 / M/s Intas Pharmaceuticals Ltd / 21120, 17986 / Clarification Letter
3 / M/s Pavior Pharmaceuticals Pvt, ltd / 6116 / Clarification Letter
4 / M/s Kasiak research Pvt, ltd / 2053, 46305, 47461 / Clarification Letter
5 / M/s LG Life Sciences India Pvt, ltd / 21484 / Clarification Letter

GLOBAL CLINICAL TRIAL

Sr. No. / Name of Firm / Reference No. / Type of Letter
1. / M/s. Quintiles / 18566 / Export NOC Approval Letter

SUBSEQUENT NEW DRUG

S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER
M/s Ipca Laboratories / 4758 / - / Approval Letter
M/s CD Pharma / 13733 / 21341 / Deficiency Letter
M/s Zim Ltd. / 5513 / - / Approval Letter

LETTER PERTAINING TO IMPORT

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
BIOCON LTD. / 24036 / Approval Letter
VETOQUINOL INDIA ANIMAL HEALTH PVT. LTD. / 22054 / Approval Letter
STERILE INDIA PVT. LTD. / 21405 / CLARIFICATION LETTER

LETTER PERTAINING TO MISC

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
SNYCHRON RESEARCH SERVICES PVT. LTD. / NIL / NIL
ALCON LABORATOERIES INDIA PVT. LTD. / NIL / NIL

MEDICAL DEVICE

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Lepu Medical Technology (Beijing) Co. Ltd. / 64143 / Approval (F-RC)
M/s. Feron Life Sciences (P) Ltd. / 19009 / Approval (F-IL)
M/s. Spica Medical Equipment’s Pvt. Ltd. / 21099 / Approval (F-IL)
M/s. Exactech India (P) Ltd. / 17797 / Approval Letter
The State Drugs Controller, Haryana (CLAA)
The Deputy Drugs Controller (I), Ghaziabad (CLAA)
(M/s. Hindustan Syringes & Medical Devices Ltd.) / FTS-34630 / Approval Letter
M/s. Clairvoyance Consulting. / 6064 / Query Letter
M/s. Envision Scientific Pvt. Ltd. / 21398 / Query Letter
M/s. Indigo Impex Pvt. Ltd. / 22443 / Query Letter
M/s. Johnson & Johnson Ltd. / 6691 / Query Letter
The Commissioner, Gujarat (CLAA)
The Deputy Drugs Controller (I), Ahmedabad (CLAA)
M/s. Angiplast Pvt. Ltd., Gujarat (CLAA) / FTS-27698 / Letter
The Deputy Drugs Controller (I), Ghaziabad (CLAA)
The State Drugs Controller, Haryana (CLAA)
M/s. Stermied Medical Devices (P) Ltd., Haryana (CLAA) / FTS-33179 / Letter

DIAGNOSTIC DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Roche Diagnostics India Pvt. Ltd. / 19239 / Approval (E-RC)
M/s. Roche Diagnostics India Pvt. Ltd. / 19239 / Approval (E-IL)
M/s. Siemens Ltd. / 6730 / Approval (R-RC)
M/s. Siemens Ltd. / 6730 / Approval (R-IL)
M/s. KHC Healthcare India Pvt. Ltd. / 18457 / Approval (IL)
M/s. MP Biomedicals Pvt. Ld. / 18815 / Approval (IL)
M/s. Siemens Ltd. / 20159 / Approval (IL)
M/s. Siemens Ltd. / 20158 / Approval (E-IL)
M/s. Roche Diagnostics India Pvt. Ltd. / 21343 / Approval (TL)
M/s. Bridgeway Medical Systems. / 21250 / Query Letter
M/s. Achira Labs Pvt. Ltd. / FTS-29008 / Letter
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
M/s. Laila Pharma. Pvt. Ltd. / - / Letter
M/s. Issar Pharma (p) Ltd., / - / Letter
M/s. Glenmark Pharmaceuticals Ltd. / - / Letter
M/s. Dr. Reddy’s Laboratories Ltd. / - / Letter
M/s. Hetero Labs Limited. / - / Letter
M/s. Ranbaxy Laboratories Ltd. / - / Letter (2)
M/s. Centaur Pharmaceuticals Ltd. / - / Letter
Dr. Pankaj Garg. / - / Letter
M/s. Intas Pharmaceuticals Ltd. / - / Approval Letter (2)
M/s. Huvepharma SEA (Pune) Ltd. / - / Letter
M/s. Y. R. Gaitonde Medical Education / - / Letter
M/s Bayer Pharmaceuticals Ltd. / - / Letter

NEW DRUG

VACCINE DIVISION

S. No. / COMPANY NAME / Dy.No. / STATUS
1 / M/s Merck Specialities Pvt, ltd / 18395 / Clarification Letter
2 / M/s Johnson & Johnson Ltd / 11557 / Clarification Letter
3 / M/s Stallen South Asia Pvt, ltd / 23198 / Approval Letter 6666

COSMETICS DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. A.B. Health Products Pvt. Ltd., New Delhi / FTS No. 20615 / Clarification Letter
M/s. Abbott Healthcare Pvt. Ltd, Mumbai / 17467 / Approval Letter
M/s. Sephora Cosmetics Private Limited, New Delhi / 16486 / Deficiency Letter
M/s. Magic Enterprises, Kerala / 16785 / Deficiency Letter
M/s. SCA Hygiene Products India Pvt. Ltd, Mumbai / 16909 / Deficiency Letter
M/s. Eureka Cosmo Private Limited, Mumbai / 17795 / Deficiency Letter
M/s. Baccarose Perfumes & Beauty Products Pvt. Ltd, Mumbai / 18022 / Deficiency Letter
M/s. SCA Hygiene Products India Pvt. Ltd, Mumbai / 16910 / Deficiency Letter
M/s. Johnson & Johnson Limited, Mumbai / 12897, 16010, 17792 / Deficiency Letter
M/s. Proyoung International Private Limited, Hyderabad / 18140, 18141 / Approval Letter
M/s. Pureplay Skin Sciences(India) Pvt. Ltd, Thane / 16805 / Approval Letter
M/s. Universal Corporation Limited, Chennai / 16350 / Approval Letter
M/s. Universal Corporation Limited, Chennai / 14899 / Approval Letter
M/s. Palsons Derma Pvt. Ltd, Kolkata / 13325 / Approval Letter