Letters for Issue on 11.12.2014

LETTERS FOR ISSUE ON 11.12.2014

1.FDC DIVISION

S.NO. NAME OF COMPANY DIARY NO DOCUMENT

1. M/s. Indoco Remedies Ltd., 37289 Letter

2.MEDICAL DEVICE

S.NO. COMPANY NAME DIARY NO STATUS

1. M/s. Terumo India Pvt. Ltd. 40580 Approval (F-RC)

2. M/s. Johnson & Johnson Ltd. 44239 Approval (R-RC)

3. M/s. Johnson & Johnson Ltd. 44239 Approval (R-IL)

4. M/s. Terumo India Pvt. Ltd. 40995 Approval (R-RC)

5. M/s. Terumo India Pvt. Ltd. 40995 Approval (R-IL)

6. M/s. Becton Dickinson India Pvt. Ltd. 9994 Approval (E-RC)

7. M/s. Becton Dickinson India Pvt. Ltd. 9994 Approval (E-IL)

8. M/s. Boston Scientific India Pvt. Ltd. 36811 Approval (R-E-RC)

9. M/s. Boston Scientific India Pvt. Ltd. 36811 Approval (R-E-IL)

10. M/s. Cadila Pharmaceuticals Ltd. 8351 Approval (F-IL)

11. M/s. Becton Dickinson India Pvt. Ltd. 9993 Approval Letter

12. M/s. Johnson & Johnson Ltd. 37706 Approval Letter

13. M/s. Boston Scientific India Pvt. Ltd. 35476 Letter

14. M/s. Becton Dickinson India Pvt. Ltd. 44244 Letter

15. M/s. Surgimedik Healthcare Pvt. Ltd. FTS-62607 Letter DIAGNOSTIC DIVISION

S.NO. COMPANY NAME DIARY NO STATUS

1. M/s. NYX Life Care Pvt. Ltd. 38056 Approval (IL)

All port offices of CDSCO.

2. M/s. Meril Diagnostics Pvt. Ltd. 38147 Approval (E-IL)

3. M/s. MHS Pharmaceuticals Pvt. Ltd. 41288 Approval (TL)

4. M/s. Pammvi Exports Pvt. Ltd. 40651 Approval Letter

All port offices of CDSCO. IMPORT

S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER 1. Abil Chempharma Pvt. Ltd. 31486 Approval Letter 2. C.J. Shah & Co. (Godown) 41867 Approval Letter

3. Gorang International 41866 Approval Letter

4. Umedica Laboratories Pvt. Ltd. 45313 Approval Letter

5. Nectar Lifesciences Ltd. (Unit- 45361 Approval Letter 1) 6. Dr. Reddys Laboratories 45714 Approval Letter Limited 7. Sun Pharma Laboratories Ltd. 45766 Approval Letter

8. Sun Pharma Laboratories Ltd. 45765 Approval Letter

9. Dilipkumar and Company 45768 Approval Letter

11. Pradipkumar & Co. 45809 Approval Letter

12. Aquatic Remedies Pvt. Ltd. 45740 Approval Letter

13. General Import Company 45741 Approval Letter (India) Pvt. Ltd. 14. Macleods Pharmaceuticals 45746 Approval Letter Limited (Unit-VII) 15. Mercury Laboratories Ltd. 45878 Approval Letter

16. Unimed Technologies Ltd. 45883 Approval Letter

17. C.J. Shah & Co. (Godown) 45806 Approval Letter

18. Novartis Healthcare Pvt. Ltd. 45947 Approval Letter

19. Novartis India Ltd. 45948 Approval Letter

20. Novartis India Ltd. 46083 Approval Letter

21. Cipla Ltd. 47850 Approval Letter

22. Ind-Swift Laboratories Limited 46637 Approval Letter

23. United Biotech Pvt. Ltd. 46615 Approval Letter

24. Pharma Zone 46864 Approval Letter

29. Sagar Rubber Products Pvt. 46857 Approval Letter Ltd. 30. Gorang International 46861 Approval Letter

31. Pratistha Pharma 46858 Approval Letter

32. Lalchand Bhimraj, 46876 Approval Letter

33. Dolphin International, 46829 Approval Letter

34. Rely Chem(Godown) 46835 Approval Letter

35. Pulse Pharma 46834 Approval Letter

36. Medi Pharma Drug House 46836 Approval Letter

37. Rajasthan Antibiotics Ltd. 46850 Approval Letter

38. Intas Pharmaceuticals Ltd. 46946 Approval Letter

39. Zoetis India Limited 46930 Approval Letter

40. C.J. Shah & Co. (Godown) 46930 Approval Letter

41. Symbio Generrics India Pvt. 48013 Approval Letter Ltd.

42. Fulford (India) Ltd. 33731 Approval Letter

43. Organon Ltd. 47471 Approval Letter

44. Eli Lilly and Co. (I) Pvt. Ltd. 46652 Approval Letter

45. Immacule Life sciences pvt. ltd. 47731 Clarification Letter

46. MSD Pharmaceuticals Pvt. Ltd. 47509 Clarification Letter

47. Biocon ltd./symbio generics 47316 Clarification Letter india pvt. ltd. 48. Biocon ltd./Aquatic Remedies 47222 Clarification Letter pvt ltd. 49. Allergen Healthcare India Pvt. 47546,47547 Clarification Letter Ltd. REGISTRATION

S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER 1. SANOFI SYNTHELABO IDNIA LTD. 43914 AMENDED LETTER 2. PFIZER LTD. NIL CANCELLATION LETTTER

3. ETHACHEM NIL CANCELLATION LETTTER

4. RUSHI CORPORATION NIL LETTER

5. JOHNSON & JOHNSON LTD. 40756 CLARIFICATION LETTER

6. SOW PHARMA 32055 CLARIFICATION LETTER

7. ESSCHEM PVT. LTD. 28979 CLARIFICATION LETTER

8. RANBAXY LAB LTDE. 43237 CLARIFICATION LETTER

9. ROCHE PRODUCTS INDIA PVT. LTD. 41152 CLARIFICATION LETTER

10. APC PHARMACEUTICALS & 42197 CLARIFICATION LETTER CHEMICALS 11. BLUE CROSS LABORATORIES LTD. 39185 CLARIFICATION LETTER

SHELF LIFE/MISC.

S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER 1. TUTON PHARMACEUTICALS 40610 APPROVAL LETTER 2. FLAMINGO PHARMACEUTICAL LTD. 44910 APPROVAL LETTER

3. DALAS BIOTECH LTD. 45803 APPROVAL LETTER

4. ASTRA LIFE CARE INDIA PVT. LTD. 45505 APPROVAL LETTER

5. MATA AMRITANANDAMAYI MATH NIL LETTER

6. MEENAKSHI MISSION HOSPITAL AND 45903 LETTER RESERACH CENTRE

VACCINE DIVISION

S. No. COMPANY NAME Dy. No. STATUS

1 M/s Mabpharm pvt , Ltd 42764 Clarification Letter

2 M/s Life cell International Pvt, 42723 Clarification Letter ltd

3 M/s Roche product India Pvt, 40263 Clarification Letter ltd

4 M/s Reliance Life Sciences Pvt, Clarification & ltd Invitation Letter

5 M/s Globion India Pvt, ltd 39093 Clarification Letter

6 M/s Venkateshwara 39482 Approval Letter Hatcheries Pvt, ltd

7 M/s Institute of Cellular 41488 Clarification Letter Therapies Pvt, ltd

8 M/s Genetech 37050 Clarification Letter

9 M/s Syngene International Ltd 42108 Clarification Letter

10 M/s Bharat Biotech 44211 Approval Letter International ltd 11 M/s Gennova Invitation Letter Biopharmaceuticals Ltd

12 M/s Biomed Pvt, ltd 45542 Approval Letter

Cosmetics Division

S.N COMPANY NAME DIARY NO STATUS O.

1. M/s. Balaji Brand Care & Marketing Pvt. Ltd, 42813 Approval Letter Kandivali(west) Mumbai

2. M/s. Palson Derma Pvt. Ltd, Kolkata 43920 Approval Letter

3. M/s. Faces Cosmetics India Pvt. Ltd, Mumbai 39101 Approval Letter

4. M/s. LG Life Sciences India Pvt. Ltd, Gurgaon, 41961 Approval Letter Haryana

5. M/s. Sree Guru Raghavendra Traders, Andhra 42050 Approval Letter Pradesh.

6. M/s. Baccarose Perfumes & Beauty Products Pvt. 39936 Approval Letter Ltd, Mumbai Cosmetics Division S.N COMPANY NAME DIARY NO STATUS O.

1. M/s. Abbott Healthcare Pvt. Ltd, Mumbai 43383 Deficiency Letter

2. M/s. Jafra Ruchi Cosmetics India Pvt. Ltd, New 43781 Deficiency Letter Delhi

3. M/s. Seslong Traders Pvt. Ltd, Bangalore , 38500 Approval Letter Karnataka

4. M/s. SSIZ International , Mumbai 41312 Approval Letter 5. M/s. Generix LifeSciences Pvt. Ltd, New Delhi 34396 Approval Letter

6. M/s. Sanctum Spa and wellness Pvt. Ltd, Mumbai 38188 Approval Letter

7. M/s. L’Oreal India Pvt. Ltd, Mumbai 39660, Approval Letter 37286, 38731

8. M/s. Ocea marine Cosmetics Pvt. Ltd, Mumbai 39622 Approval Letter

9. M/s. Modi Revlon Pvt. Ltd, New Delhi 38854 Approval Letter

10. M/s. Wockhardt Limited, Mumbai 39986 Approval Letter

BA/BE DIVISION

S. NO. COMPANY NAME FTS NO. /Diary STATUS No.

01 M/s. Clinsync Clinical Research Pvt. 18557 Approval Ltd., Telangana