LETTERS FOR ISSUE ON03.11.2014

VACCINE DIVISION

S. No. / COMPANY NAME / Dy. No. / STATUS
1 / M/s Cadila Healthcare , Ltd / 38831 / Clarification Letter
2 / M/s Intervet India Pvt, ltd / 11942 / Clarification Letter
3 / M/s EliLilly and company (i) pvt ,ltd / 27595 / Clarification Letter
4 / M/s Roche Products (India) pvt, ltd / 42619 / Clarification Letter
5 / M/s G.C. Chemie Pharmie ltd / 23403 / Clarification Letter
6 / M/s Torrent Pharmaceuticals ltd / 25885 / Clarification Letter
7 / M/s Sanofi Pasteur India Pvt, ltd / 11210 / Clarification Letter
8 / M/s Bharat Serum & Vaccine Ltd. / 43283 / Clarification Letter

COSMETICS DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. PZ Cussons India Private Limited, Mumbai / 35689 / Deficiency Letter
M/s. Faces Cosmetics India Pvt. Ltd, Mumbai / 34693 / Deficiency Letter
M/s. Hindustan Unilever Ltd, Mumbai / 34099 / Deficiency Letter

FDC DIVISION

S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT
M/s. Bayer Pharmaceuticals Pvt. Ltd., / 39707 / Letter
M/s. IPCA Laboratories Ltd. / 26231 / Letter
M/s. Glenmark Pharmaceuticals Ltd., / 38855 / Letter
M/s. Sain Medicaments Pvt. Ltd., / 58282 / Letter
M/s. Famy Care Ltd., / 40195 / Letter
M/s. Hippo Labs Pvt. Ltd., / 45411 / Letter
M/s. Synokem Pharmaceuticals Pvt. Ltd., / 39962 / Clarification Letter
M/s. Synokem Pharmaceuticals Pvt. Ltd., / 41513 / Letter
M/s. Psychotropics India ltd., / 43468 / Clarification Leter
M/s. Versatile Pharma Pvt. Ltd., / 49102 / Letter
M/s. GlaxoSmithKline Pharmaceuticals Ltd., / 39929 / Clarification Leter
M/s. Pulse Pharmaceuticals Pvt. Ltd., / 56780 / Letter
M/s. Livin Formulations, / 43581 / Clarification Leter

SUBSEQUENT NEW DRUG

S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER
M/s Ranbaxy Laboratories Ltd., / 29737 / 43714 / Query Letter
M/s Adhish Industries, / - / 39688 / Query Letter
M/s Strides Arcolab Ltd., / 24902 / - / Query Letter

NEW DRUG

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
M/s. J B chemicals & Pharmaceuticals Limited / - / Query Letter
M/s. Pfizer Products India Private Limited / - / Query Letter
M/s. MSN Labs Ltd. / - / Query Letter (3)
Dr. Pankaj Garg. / - / Query Letter
M/s. Bharat Serum and Vaccine Ltd / - / Query Letter
M/s. BDR Pharmaceuticals / - / Query Letter
M/s. Lupin Limited / - / Query Letter
M/s Ajanta Pharma Limited / - / Query Letter
Dr. Anurag Srivastava / - / Query Letter
M/s Emcure Pharmaceuticals Ltd / - / Query Letter
Dr. Shobha Nerlikar / - / NOC Letter
Dr. Kalpagam Polasa / - / Test License

MEDICAL DEVICE

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Alkem Laboratories Ltd. / 33452 / Query Letter
M/s. Apothecaries Pvt. Ltd. / Query Letter
M/s. Abbott Healthcare Pvt. Ltd. / 18732 / Query Letter
M/s.Alteco Medical AB. / FTS-29831 / Query Letter
M/s. Atlantic Pharmaceuticals. / 42267 / Query Letter
M/s. Accrediated Consultants Pvt. Ltd. / 37743 / Query Letter
M/s. Bard India Healthcare Pvt. Ltd. / 30005 / Query Letter
M/s. Biomet Orthopaedic India Pvt. Ltd. / 25087 / Query Letter
M/s. Biomed Orthopaedic India Pvt. Ltd. / 39031 / Query Letter
M/s. BioardMedisys Pvt. Ltd. / 36139 / Query Letter
M/s. B L Lifesciences Pvt. Ltd. / 31552 / Query Letter
M/s. Becton Dickinson India Pvt. Ltd. / 24904 / Query Letter
M/s.Clinicare (I) Pvt. Ltd. / 24214 / Query Letter
M/s. Exactech India (P) Ltd. / 27064 / Query Letter
M/s. Emergo (I) Consulting Pvt. Ltd. / 39997 / Query Letter
M/s. Johnson & Johnson Ltd. / 32501 / Query Letter
M/s. Johnson & Johnson Ltd. / 27562 / Query Letter
M/s. Kumar & Brother Pharmaceutical Distributor. / 23057 / Query Letter
M/s. Meril Life Sciences India Pvt. Ltd. / 41445 / Query Letter
M/s. Meril Life Sciences India Pvt. Ltd. / 27591 / Query Letter
M/s. Vigen Healthy Tech India Pvt. Ltd. / FTS-29831 / Query Letter
M/s. Meril Life Sciences India Pvt. Ltd. / 15633 / Query Letter
M/s. Meril Life Sciences India Pvt. Ltd. / 11855 / Query Letter
M/s. Meril Life Sciences India Pvt. Ltd. / 11852 / Query Letter
M/s. Meril Life Sciences India Pvt. Ltd. / 12546 / Query Letter
M/s. Meril Life Sciences India Pvt. Ltd. / 11854 / Query Letter
M/s. Meril Life Sciences India Pvt. Ltd. / 34193 / Query Letter
M/s. Meril Life Sciences India Pvt. Ltd. / 28660 / Query Letter
M/s. Meril Life Sciences India Pvt. Ltd. / 11264 / Query Letter
M/s. Meril Life Sciences India Pvt. Ltd. / 11853 / Query Letter
M/s. Meril Life Sciences India Pvt. Ltd. / 11851 / Query Letter
M/s. Molnlycke Healthcare India Pvt. Ltd. / 21595 / Query Letter

DIAGNOSTIC DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. L B Diagnostics. / 39826 / Query Letter
M/s. Medispec India Ltd. / 37091 / Query Letter
M/s. Transasia Bio-Medicals Ltd. / 33700 / Query Letter
The Director, M/s. Care Hospital, Hyderabad. / Nil / Query Letter

GLOBAL CLINICAL TRIAL

Sr. No. / Name of Firm / Reference No. / Type of Letter
1. / M/s. Wyeth / 39813 / Clarification letter
2. / M/s. Pfizer / 40284 / Clarification Letter
3. / M/s. Kendle / 40683 / Clarification Letter
4. / M/s. Quintiles / 42418 / Clarification Letter

LETTER PERTAINING TO IMPORT

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
GSK PHARMACEUTICALS LTD. / 40342,40238,40341,
40346,40340,40343,40344,
40345, 40241,40239,40242 / 11 CLARIFICATION LETTER
JOHNSON & JOHNSON LTD. / 41265,41263,41514,,41268,
41264,41267,41860,41861,41866,41261 / 10 CLARIFICATION LETTER

LETTER PERTAINING TO REGISTRATION

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
GSK PHARMACEUTICALS LTD. / 17964,17965 / 02 CLARIFICATION LETTER
BAUSCH & LOMB EYECARE PVT. LTD. / 20647 / CLARIFICATION LETTER

LETTER PERTAINING TO SHELF LIFE

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
SAIBLISS DRUGS & PHARMACEUTICAL / 33591 / CLARIFICATION LETTER