LETTERS FOR ISSUE ON 15.10.2014
BA/BE DIVISION
S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS01 / M/s. Clinigene International Ltd., Bangalore / 37800 / Query
02 / M/s. Ranbaxy Laboratories ltd., Noida / 37280 / Amendment
LVP DIVISION
S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS01 / M/s. Sun Pharma, Gujarat / 54643 / Approval
02 / M/s. Fresenius Kabi Ltd., Solan / 58428 / Approval
03 / M/s. Cipla Ltd., Goa / 58022 / Approval
04 / M/s. Eurolife Healthcare, Uttarakhand / 58358 / Approval
05 / M/s. Gland Pharma Ltd., Hyderabad / 54626 / Approval
06 / M/s. Abaris healthcare Pvt. Ltd., Gujarat / 44012, 26302, 34958, 33079, 59087 / Approval
07 / M/s. HLL Life care Ltd., Kerala / 58070 / Approval
08 / M/s. Scan Biotech C/o. M/s. Ahlcon Parenterals, Alwar / 33358 / Approval
09 / M/s. Lincoln Pharmaceuticals C/o. M/s. Shree Krishnakeshav, Gujarat / 56566 / Approval
MEDICAL DEVICE
M/s. B. Braun Medical (India) Pvt. Ltd. / 34427 / Query Letter1. / M/s. Johnson & Johnson Ltd. / 22378 / Query Letter
2. / M/s. Bausch & Lomb Eyecare India Pvt. Ltd. / 37038 / Query Letter
3. / M/s. Best Hearing Solutions / 36427 / Query Letter
4. / M/s. B. Braun Medical (India) Pvt. Ltd. / 34426 / Query Letter
5. / M/s. Surya Surgicals Industries / 38150 / Query Letter
6. / M/s. Boston Scientific India Pvt. Ltd. / 33371 / Query Letter
7. / M/s. Chitrarath / 33719 / Query Letter
8. / M/s. Nipro India Corporation Pvt. Ltd. / 33819 / Query Letter
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Krypton Biomedical Pvt. Ltd. / 19238 / Query Letter
2. / M/s. Alere Medical Pvt. Ltd. / 36870 / Query Letter
3. / M/s. Roche Diagnostics India Pvt. Ltd. / 23093 / Query Letter
4. / M/s. Roche Diagnostics India Pvt. Ltd. / 22689 / Query Letter
5. / M/s. Siemens Ltd. / 32756 / Query Letter
6. / M/s. U R Biomdeical Pvt. Ltd. / 36988 / Query Letter
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER1. / M/s Akums Drugs & Pharmaceuticals Ltd., / 30683 / 45059 / Deficiency Letter
2. / M/s Alembic Pharmaceuticals Ltd., / 57980 / 80568 / Deficiency Letter
3. / M/s Alcon Laboratories India Pvt.Lte., / 30263 / 44434 / Deficiency Letter, IPC (2)
4. / M/s Raptim Research Ltd., / 25858 / 38386 / Deficiency Letter
5. / M/s Zim Laboratories Ltd., / 57913 / 80719 / BE NOC
6. / M/s Troikaa Pharmaceuticals Ltd., / 27456 / - / Deficiency Letter
7. / M/s SymbiotecPharmalab Limited, / 31976 / 47863 / Deficiency Letter
NEW DRUG
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / M/s. MSN Laboratoies Ltd. / - / Test License
LETTER PERTAINING TO REGISTRATION
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / APOTHECARIES PVT. LTD. / 19916 / CLARIFICATION LETTER
2. / LASCO INTERNATIONAL / 31889 / CLARIFICATION LETTER
3. / EASTERN CHEMICAL PVT. LTD. / 31753,31754 / 2CLARIFICATION LETTER
LETTER PERTAINING TO SHELF LIFE
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / APEX DRUG HOUSE / 38194 / APPROVAL LETTER
2. / TUTON PHARMACEUTICAL / 38357,38355,38354 / 3 APPROVAL LETTER
3. / ASTRA LIFE CARE INDIA PVT. LTD. / 38799 / APPROVAL LETTER
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
1. / ROCHE PRODUCTS INDIA PVT. LTD. / 30944 / AMENDED LETTER
VACCINE DIVISION
S. No. / COMPANY NAME / Dy. No. / STATUS1 / M/s Shantha Biotechnices Ltd / 22495 / Approval Letter
2 / M/s Bristol Myers Squibb India Pvt. Ltd / 37890 / Clarification Letter
3 / M/s Synergy Diagnostics Ltd / Approval Letter
4 / M/s Elililly India Pvt, . Ltd / 14908 / Acknowledge Letter
5 / M/s Virbac Animal Health India Pvt, ltd / 11200 / Approval Letter
6 / M/s Duraent Biological ltd / Approval Letter
7 / M/s G.C. Chemie Pharmie Ltd / Cancellation Letter
8 / M/s Prosper Channel Lifesciences India Pvt, ltd / Approval Letter