Letters For Issue On 19.07.2011: 1. Be Noc/Test Licence

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LETTERS FOR ISSUE ON 19.07.

2011
1. BE NOC/TEST LICENCE

S. NO. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19.

NAME OF THE COMPANY M/s. Alembic Ltd., Vadodara M/s. Azidus Laboratories Ltd., Chennai M/s. BA Research India Ltd., Ahmedabad M/s. BA Research India Ltd., Ahmedabad M/s. Bioserve Clinical Research Pvt. Ltd., Hyderabad M/s. Bioserve Clinical Research Pvt. Ltd., Hyderabad M/s. Dr. Reddy's Laboratories Ltd., Hyderabad M/s. Jubilant Life Sciences Ltd., Noida, UP M/s. Lambda Therapeutic Research Ltd., Ahmedabad M/s. Lotus Labs Pvt. Ltd., Bangalore M/s. Orchid Healthcare, Tamil Nadu M/s. Orchid Healthcare, Tamil Nadu M/s. Piramal Clinical Research, Hyderabad M/s. Ranbaxy Laboratories Ltd., Gurgaon M/s. Sandoz Pvt. Ltd., Thane M/s. Sun Pharma Advanced Research Company Ltd., Vadodara M/s. Sun Pharmaceutical Industries Ltd., Vadodara M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad

REF. NO. 19436 19692 21575 15692 23607 24471 10318 26839 21716 23355 23494 25857 28472 28450 15816 27085 18296 21614 12898

TYPE OF LETTER Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter

2. NARCOTICS EXPORT NOC


S.NO 1 2 3 4 5 6 7 FIRM NAME M/s Aventis Pharma M/s Aventis Pharma M/s Rusan Pharma ltd M/s Lake Chemicals M/s Ipca Laboratories Limited M/s Embio Limited M/s R.L Fine Chem DIARY NO 32167 29388 28475 28690 27039 29062 29882 STATUS Approval letter Approval letter Approval letter Approval letter Deficiency letter Approval letter Approval letter

3. COSMETIC DIVISION
S.NO NAME OF . COMPANY 1. M/s. Guthy Renker Marketing Pvt Ltd, New Delhi 2. M/s. Modi Revlon Private Lmited, New Delhi DIARY NO 31 851 304 90 Status Approval Letter Deficiency Letter

4. Additional Dosage, Indication and Strength


S. NO. 1. 2. 3. NAME OF THE COMPANY M/s NU Therapeutics Ltd. M/s Ajanta Pharma Ltd. M/s Fulford(India) Ltd. REF. NO. 20417 5017 17904 TYPE OF LETTER Deficiency letter Deficiency letter Deficiency letter

5. MEDICAL DEVICES

S. NO. 1.

NAME OF COMPANY Kalyx India Healthcare

DIARY NO. 27519

DOCUMENT Deficiency Letter

6. DIAGNOSTIC KITS

S. NO. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20.

NAME OF COMPANY Immunoshop Ypsomed India Lilac Medicare Shanti Medical Shanti Medical Sirus Biocare Horiba India Iris Healthcare Nipro India White Mountain Anand Brothers Anand Brothers Uritest Medical Beckman Coulter Microgene Diagnostic Microgene Diagnostic Biogenuix Medsystems Biogenuix Medsystems CPC Diagnostics Vishat Diagnostics

DIARY NO. 31227 29626 28142 27507 29554 27197 27856 31545 29555 29963 28014 27145 31329 30789 31327 29380 27952 27951 28023 28371

DOCUMENT Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter Approval Letter Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter

7. VACCINE DIVISION
S. NO. 01 02 03 COMPANY NAME M/s G.C. Chemice Pharmie Ltd DY.NO. 30029 STATUS Deficiency Letter Deficiency Letter Approval Letter

M/s Amgen Technology Pvt Ltd 50207 M/s Panacea Biotec Ltd 2465

8. EXPORT NOC OF BIOLOGICAL SAMPLES


S. No. 01 02 03 04 COMPANY NAME NO. M/s Auroville Healthcare research M/s Novartis Healthcare Pvt. Ltd. Vaccine Division M/s DiagnoSearch Life sciences M/s Lambda Therapeutic 30539 26505 24021 and 24021 30024, 30026, 27422, 26917, 21715 Deficiency letter Deficiency letter Deficiency letter Deficiency letter (6) DY. STATUS

9. FDC DIVISION
S.NO. 1. 2. NAME OF COMPANY M/s. Ajanta Pharma M/s. Akums Drugs DIARY NO 10221 20597 DOCUMENT Letter Approval

Letter 3. 4. 5. 6. 7. 8. 9. M/s. Akums Drugs M/s. Akums Drugs M/s. Akums Drugs M/s. Cadila Healthcare M/s.GlaxoSmithKline Pharmaceuticals M/s. Ontop Pharmaceuticals M/s. Vapi Care 17867 17867 2728 17019 11189 17662 20839 Approval Letter Deficiency Letter Expert Letter Expert Letter Deficiency Letter Letter Deficiency Letter

10. REGESTRAION
SR.NO 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. NAME OF APPLICANT ORGANON (I) LTD BIOTAVIA LABS PVT. LTD. CITICARE PHARMA PVT. LTD. ESSCHEM PVT. LTD ALCON LAB (INDIA) PVT. LTD. GLAXO SMITH KLINE PHARMACEUTICALS LTD UCB INDIA PVT. LTD. DIARY NO. 82174,82175 29143 32050 31344 10266 14877 13664,14963 TYPE OF LETTER 3 DEFICIENCY LETTER DEFICIENCY LETTER DEFICIENCY LETTER DEFICIENCY LETTER DEFICIENCY LETTER DEFICIENCY LETTER 2 DEFICIENCY LETTER DEFICIENCY LETTER DEFICIENCY LETTER DEFICIENCY LETTER DEFICIENCY LETTER DEFICIENCY LETTER DEFICIENCY LETTER DEFICIENCY LETTER

FULFORD(INDIA) LTD. 31543 AVENTIS PHARMA 32070 LTD. NOVARTIS INDIA LTD. 13074 JOHNSON & JOHNSON LTD. RUSHI CORPORATION FMC INDIAN LTD. KENKO CORPORATION 14232 52015 21651 31416

15. 16. 17.

BASF INDIA LTD SANOFI SYNTHELABO (I) LTD. RUSKIN CHEMIPHARM

32881 21816

DEFICIENCY LETTER DEFICIENCY LETTER AMENDMENT LETTER

11.DUAL USE
SR.NO 1. 2. 3. 4. 5. 6. 7. NAME OF APPLICANT FDC LTD. DECCAN NUTRACEUTICALS PVT. LTD. HI MEDIA LABORATORIES PVT. LTD. CLARIS LIFE SCIENCES LTD. BELCO PHARMA THEMIS MEDICARE LTD. INTERVET INDIA PVT. LTD. DIARY NO. 29881 32155 27891,27891 28952 TYPE OF LETTER APPROVAL LETTER APPROVAL LETTER 2 APPROVAL LETTER APPROVAL LETTER APPROVAL LETTER APPROVAL LETTER DEFICIENCY LETTER

17256 28463

12.IMPORT
SR.NO 1. 2. 3. 4. 5. 6. 7. 8. 9. NAME OF APPLICANT BIOCON LTD. SUN PHARMACEUTICAL INDUSTRIES LTD. BIOCON LTD./ SHEETAL PHARMA WYETH LTD. BIOCON LTD./ PRADIPKUMAR & Co. BIOCON LTD./ ARIL PHARMACEUTICALS ARISTO LABORATORIES PVT. LTD. MEDLEY PHARMACEUTICALS LTD. BAXTER(I) PVT. LTD. DIARY NO. 27325 29942 29865 29965 30099 30100 30256,30257 31623 32628 TYPE OF LETTER DEFICIENCY LETTER DEFICIENCY LETTER DEFICIENCY LETTER DEFICIENCY LETTER DEFICIENCY LETTER DEFICIENCY LETTER 2 DEFICIENCY LETTER DEFICIENCY LETTER DEFICIENCY LETTER

10. 11. 12. 13. 14. 15. 16. 17. 18.

EMPIRE INDUSTRIES LTD./ PHARMACHEM PHARMACHEM ASHISH LIFE SCINECE PVT. LTD./ MEDI DRUG HOUSE MICRO LABS LTD. NIRMA LTD. KALGOV LBAS LTD. GORANG INTERNATIONAL MEDI PHARMA DRUG HOUSE MEDI PHARMA DRUG HOUSE/DESA MARKETING INTERNATIONAL GANGWAL CHEMICALS PVT LTD./BAXTER(I)PVT. LTD. CADILA HEALTHCARE LTD. COSME PHARMA LTD. JUBLIANT DRAXIMAGE LTD. AVENTIS PHARMA LTD. GLAXO SMITHKLINE PHARMACEUTICALS LTD.

30836 30836 30784 30929 30779 31141 31745 31866 31866

DEFICIENCY LETTER DEFICIENCY LETTER DEFICIENCY LETTER DEFICIENCY LETTER DEFICIENCY LETTER DEFICIENCY LETTER DEFICIENCY LETTER DEFICIENCY LETTER DEFICIENCY LETTER DEFICIENCY LETTER DEFICIENCY LETTER DEFICIENCY LETTER DEFICIENCY LETTER DEFICIENCY LETTER DEFICIENCY LETTER

19.

31744

20. 21. 22. 23. 24.

30580 30448 31925 31357 30947

13. NEW DRUGS


S.NO. 1. 2. 3. 4. 5. 6. NAME OF APPLICANT M/s. Merck Ltd. M/s. Novartis Healthcare M/s. Ipca Labs M/s. Sequent Scientific M/s. Novartis India M/s. Intas Pharma DIARY NO. 23386 17090 10782 58523 25270 TYPE OF LETTER Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter Deficiency Letter Approval Letter

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