Written Confirmation

LETTERS FOR ISSUE ON 19.05.2015

IMPORT

S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER 1. PFIZER PRODUCTS INDIA PVT. 10778 AMENDMENT LTD. LETTER 2. HUVEPHARMA SEA (PUNE)PVT. 12232 AMENDMENT LTD., LETTER 3. C.J. SHAH & CO. (GODOWN) 12692 APPROVAL LETTER

4. PANACEA BIOTEC LIMITED 12734 APPROVAL LETTER

5. ZYDUS HEALTHCARE 12773 APPROVAL LETTER

6. CADILA HEALTHCARE LTD. 12772 APPROVAL LETTER

7. MICRO LABS LTD. 12688 APPROVAL LETTER

8. NANDLAL BANKATLAL PVT. 12659 APPROVAL LETTER LTD.

9. AJANTA PHARMA LIMITED 12743 APPROVAL LETTER

10. S.A. ENTERPRISES 12658 APPROVAL LETTER

12. NIRMA LIMITED 12804 APPROVAL LETTER

13. MSC CHEMICALS 12884 APPROVAL LETTER

14. ZOETIS INDIA LIMITED 12758 APPROVAL LETTER

15. KEYUR PHARMACHEM INDIA 12928 APPROVAL LETTER PVT. LTD.

16. CHANDRA BHAGAT PHARMA 12732 APPROVAL LETTER PRIVATE LIMITED

17. SANLAR IMEX SERVICES PVT. 8148 APPROVAL LETTER LTD.

18. RAJASTHAN ANTIBIOTICS LTD. 11111 APPROVAL LETTER

19. KETAN PHARMA, 12206 APPROVAL LETTER

20. ALKEM HEALTH SCIENCE 12228 APPROVAL LETTER

21. HARISH ENTERPRISES, 12208 APPROVAL LETTER 22. GORANG INTERNATIAL 12207 APPROVAL LETTER

23. AQUATIC REMEDIES PVT. LTD. 12312 APPROVAL LETTER

25. NAPROD LIFESCIENCES PVT. 12341 APPROVAL LETTER LTD.

26. UNIMARK REMEDIES LTD. 12289 APPROVAL LETTER

27. DPB ANTIBIOTICS 12314 APPROVAL LETTER

28. GORANG INTERNATIONAL 12315 APPROVAL LETTER

29. VYSALI PHARMACEUTICALS 12394 APPROVAL LETTER LIMITED

30. STERILE INDIA (PVT.) LTD. 12528 APPROVAL LETTER

33. NEON LABORATORIES LTD. 12423 APPROVAL LETTER

34. CONCEPT PHARMACEUTICALS 12495 APPROVAL LETTER LTD.,

35. DILIPKUMAR AND COMPANY 12559 APPROVAL LETTER

36. ASTRA PHARMACEUTICALS 12494 APPROVAL LETTER

37. PRATISTHA PHARMA1 12492 APPROVAL LETTER

38. ANM PHARMA PVT. LTD. 12629 APPROVAL LETTER

39. ANANTCO ENTERPRISES PVT. 12628 APPROVAL LETTER LTD.

41. DR. REDDYS LABORATORIES 12182 APPROVAL LETTER LTD.

42. RANBAXY LABORATORIES 10031 APPROVAL LETTER LTD.,

REGISTRATION S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER 1. PFIZER LTD. 10780,50180 APPROVEL LETTER CLARIFICAITON LETTER 2. RUSHI CORPORATION, 9104 AMENDMENT LETTER 3. INTERVET INDIA PVT. LTD. 10426 CLARIFICAITON LETTER 4. ESSCHEM PVT.LTD 4098 CLARIFICAITON LETTER 5. KENKO CORPORATION (I.B.O.) 7927 CLARIFICAITON LETTER 6. SINOPHARM INDIA PVT LTD, 5456 CLARIFICATION LETTER 7. SHAH TC OVERSEAS PVT LTD, 46382 CLARIFICATION LETTER 8. FERRING PHARMACEUTICALS 4426 CLARIFICATION PVT.LTD. , LETTER 9. K.P MANISH GLOBAL 40865 APPROVAL LETTER INGREDIENTS 10. JOHNSON & JOHNSON LTD. 4922 CLARIFICAITON LETTER 11. RANBAXY LABORATORIES 4381 CLARIFICAITON LTD., LETTER 12. SERDIA PHARMACEUTICAL (I) 11010 AMENDMENT PVT.LTD. LETTER 13. UNITRADE AGENCIES, 11700 AMENDMENT LETTER 14. UNI-CHEMIE INTERNATIONAL 8367 CLARIFICAITON LETTER 15. ELI-LILLY AND COMPANY (I) 47852 CLARIFICAITON PVT. LTD., LETTER

BA/BE DIVISION

S. NO. COMPANY NAME FTS NO. /DIARY STATUS NO.

01 M/S. PANEXCELL CLINICAL LAB 13946 QUERY PVT. LTD., MUMBAI

LVP DIVISION S. NO. COMPANY NAME FTS NO. /DIARY STATUS NO.

01 M/S. J. B. CHEMICALS C/O. M/S. 19868 APPROVAL UNIQUE OHARMACEUTICALS, GUJRAT

02 M/S. GLAND PHARMA LTD., 19552 APPROVAL HYDERABAD

03 M/S. AVISON PHARMACEUTICALS 23018 APPROVAL C/O. ABARIS HEALTHCARE LTD., GUJARAT

04 M/S. CLARIS INJECTABLE C/O. M/S. 21959, 21958, 21962, APPROVAL CLARIS OTSUKA, GUJARAT 21961, 21960

NEW DRUG

S.NO. NAME OF APPLICANT DIARY TYPE OF LETTER NO. 1. M/S. LUPIN LIMITED - QUERY LETTER

WRITTEN CONFIRMATION INTERNATIONAL CELL

S. NO FIRM NAME TYPE OF LETTER 1. M/S. GLENMARK GENERICS LTD., GUJARAT WC 2. M/S. GLENMARK PHARMACEUTICALS LTD, WC GUJARAT 3. M/S. USV LTD., RATNAGIRI WC

GLOBAL CLINICAL TRIAL

SR. NO. NAME OF FIRM REFERENCE NO. TYPE OF LETTER

1. M/S. INC RESEARCH 9319 TL APPROVAL LETTER

2. M/S. YRG CARE 12964 TL APPROVAL LETTER 3. M/S. NOVARTIS 13887 / 13209 CHANGE IN PI / NEW SITES APPROVAL LETTER

4. M/S. NOVONORDISK 13308/14229 CHANGE IN SITE ADDRESS/CHANGE IN PI APPROVAL LETTERS

5. M/S. MAYA CLINICALS 14385 NEW SITES APPROVAL LETTER

VACCINE DIVISION

S. NO. COMPANY NAME DY. NO. STATUS

1 M/S SERUM INSTITUTE OF 10663 PERMISSION LETTER INDIA LTD

2 M/S SANDOR MEDICAIDS PVT, 11619 APPROVAL LETTER LTD

3 M/S ROCHE PRODUCTS INDIA 13582, 13894 APPROVAL LETTER PVT, LTD

4 M/S GSK PHARMACEUTICALS 13446, 35767, 6401 APPROVAL LETTER LTD

5 M/S ZOETIS INDIA LTD 9197 AMENDMENT LETTER

6 M/S PANACEA BIOTECH LTD 12000 CLARIFICATION LETTER

7 M/S ELI LILLY AND COMPANY 7935 AMENDMENT LETTER INDIA PVT, LTD

8 M/S BHARAT BIOTECH 2223 CLARIFICATION LETTER INTERNATIONAL LTD

9 M/S ORGANON INDIA PVT, LTD 12702 APPROVAL LETTER

10 M/S BOEHRINGER INGELHEIM 10637 APPROVAL LETTER INDIA PVT, LTD

11 M/S NOVATIS HEALTHCARE 12200, 9545, APPROVAL LETTER PVT, LTD

12 M/S CADILA 38915 AMENDMENT LETTER PHARMACEUTICALS LTD 13 M/S NOVO NORDISK INDIAPVT, 30128 APPROVAL LETTER LTD

14 M/S ALPHA DRUGS 10311 AMENDMENT LETTER

15 M/S BHARAT SERUM AND 10230, 11422 AMENDMENT & VACCINE LTD CONTINUATION LETTER

16 M/S PLASMAGEN BIOSCIENCES APPROVAL LETTER PVT, LTD

MEDICAL DEVICE

S.NO. COMPANY NAME DIARY NO STATUS

1. M/S. BARD INDIA HEALTHCARE PVT. LTD. 4719 APPROVAL (F-RC)

2. M/S. BARD INDIA HEALTHCARE PVT. LTD. 4719 APPROVAL (F-IL)

3. M/S. EMERGO (INDI) CONSULTING PVT. LTD. 4993 APPROVAL (F-RC)

4. M/S. STRYKER INDIA PVT. LTD. 5467 APPROVAL (F-RC)

5. M/S. STRYKER INDIA PVT. LTD. 5467 APPROVAL (F-IL)

6. M/S. PLEXUS MEDICA. 8321 APPROVAL (E-RC)

7. M/S. PLEXUS MEDICA. 8321 APPROVAL (E-IL)

8. M/S. STRYKER INDIA PVT. LTD. 5868 APPROVAL (E-RC)

9. M/S. STRYKER INDIA PVT. LTD. 5868 APPROVAL (E-IL)

10. M/S. ALPHA DENT IMPLANTS PVT. LTD. 12408 APPROVAL (F-IL)

11. M/S. MANIK MEDICAIDS. 12579 APPROVAL (F-IL)

12. M/S. ST. JUDE MEDICAL INDIA PVT. LTD. 5298 APPROVAL (R-IL)

13. M/S. BIOMET ORTHOPAEDICS INDIA PVT. LTD. 3107 LETTER

14. M/S. B. BRAUN MEDICAL (INDIA) PVT. LTD. 2185 LETTER

15. M/S. BOSTON SCIENTIFIC INDIA PVT. LTD. 6524 LETTER

16. M/S. COLOPLAST (INDIA) PVT. LTD. 6795 LETTER

17. M/S. JOHNSON & JOHNSON LTD. 41149 QUERY LETTER 18. M/S. MERIT MEDICAL SYSTEMS INDIA PVT. 5500 QUERY LETTER LTD.

19. M/S. OPTIMUS PHARMA CONSULTING. 49734 QUERY LETTER

20. M/S. SMITH & NEPHEW HEALTHCARE PVT. 5997 LETTER LTD.

IMPORT

S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER 1. SANLAR IMEX SERVICES PVT. 8148 APPROVAL LETTER LTD. 2. RAJASTHAN ANTIBIOTICS LTD. 11111 APPROVAL LETTER

3. KETAN PHARMA, 12206 APPROVAL LETTER

4. ALKEM HEALTH SCIENCE 12228 APPROVAL LETTER

5. HARISH ENTERPRISES, 12208 APPROVAL LETTER

9. NAPROD LIFESCIENCES PVT. 12341 APPROVAL LETTER LTD. 10. UNIMARK REMEDIES LTD. 12289 APPROVAL LETTER

11. DPB ANTIBIOTICS 12314 APPROVAL LETTER

13. VYSALI PHARMACEUTICALS 12394 APPROVAL LETTER LIMITED 14. STERILE INDIA (PVT.) LTD. 12528 APPROVAL LETTER

15. NANDLAL BANKATLAL PVT. 12460 APPROVAL LETTER LTD. 16. NANDLAL BANKATLAL PVT. 12461 APPROVAL LETTER LTD. 17. NEON LABORATORIES LTD. 12423 APPROVAL LETTER

18. CONCEPT PHARMACEUTICALS 12495 APPROVAL LETTER LTD., 19. DILIPKUMAR AND COMPANY 12559 APPROVAL LETTER

20. ASTRA PHARMACEUTICALS 12494 APPROVAL LETTER 21. PRATISTHA PHARMA 12492 APPROVAL LETTER

22. ANM PHARMA PVT. LTD. 12629 APPROVAL LETTER

23. ANANTCO ENTERPRISES PVT. 12628 APPROVAL LETTER LTD. 24. AQUATIC REMEDIES PVT. LTD. 12493 APPROVAL LETTER

25. DR. REDDYS LABORAORIES 12182 APPROVAL LETTER LTD. 26. C.J. SHAH & CO. (GODOWN) 12692 APPROVAL LETTER

27. PANACEA BIOTEC LIMITED 12734 APPROVAL LETTER

28. ZYDUS HEALTHCARE 12773 APPROVAL LETTER

29. CADILA HEALTHCARE LTD. 12772 APPROVAL LETTER

30. MICRO LABS LTD. 12688 APPROVAL LETTER

31. NANDLAL BANKATLAL PVT. 12659 APPROVAL LETTER LTD. 32. AJANTA PHARMA LIMITED 12743 APPROVAL LETTER

35. NIRMA LIMITED 12804 APPROVAL LETTER

36. MSC CHEMICALS 12884 APPROVAL LETTER

37. ZOETIS INDIA LTD. 12758 APPROVAL LETTER

38. KEYUR PHARMACHEM INDIA 12928 APPROVAL LETTER PVT. LTD. 39. CHANDRA BHAGAT PHARMA 12732 APPROVAL LETTER PVT LTD. 40. RANBAXY LABORATORIES 10331 APPROVAL LETTER LTD. 41. INTERNVET INDIA PVT. LTD. 6648 CLARIFICATION LETTER 42. CENTAUR PHARMACEUTICALS 7447 CLARIFICATION PVT. LTD. LETTER 43. PFIZER PRODUCTS INDIA PVT. 10201 CLARIFICATION LTD. LETTER 44. JOHNSON & JOHNSON PV.T 10358 CLARIFICATION LTD. LETTER 45. MSD PHARMACEUTICALS PV. 9827 CLARIFICATION LTD. LETTER 46. LG LIFE SCIENCES INDIA PV.T 10738,8573 02 CLARIFICATION LTD. LETTER 47. HUVEPHARMA SEA PUNE PV. 12232 CLARIFICATION LTD. LETTER 48. PFIZER PRODUCTS INDIA PVT. 10778 AMENDED LETTER LTD. 49. BAXTER INDIA PVT. LTD. 6465,11099 4 AMENDED LETTER 50. KIMIA BIOSCIENCE PVT. LTD. 12940 AMENDED LETTER

REGISTRATION

S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER 7. PFIZER LTD. 10780,50180 APPROVEL LETTER

8. K.P MANISH GLOBAL 40865 APPROVAL LETTER INGREDIENTS 9. NEW CHEM SPA 14106 APPROVAL LETTER 10. APC PHARMACEUTICALS 10411 APPROVAL LETTER 11. SHAH TC OVERSEAS PVT LTD, 43747 APPROVAL LETTER 12. NOVARTIS HEALTHCARE PVT. 8620 APPROVAL LETTER LTD. 13. UNITRADE AGENCIES, 11700 AMENDMENT LETTER 14. RUSHI CORPORATION, 9104 AMENDMENT LETTER 15. SERDIA PHARMACEUTICAL (I) 11010 AMENDMENT PVT.LTD. LETTER 16. ESSCHEM PVT.LTD 4098 CLARIFICAITON LETTER 17. SINOPHARM INDIA PVT LTD, 5456 CLARIFICATION LETTER 18. SHAH TC OVERSEAS PVT LTD, 46382,10746 02 CLARIFICATION LETTER 19. ROCHE PRODUCTS INDIA PVT. 41152 CLARIFICATION LTD. LETTER 20. ELI-LILLY AND COMPANY (I) 47852 CLARIFICAITON PVT. LTD., LETTER 21. UNI-CHEMIE INTERNATIONAL 8367 CLARIFICAITON LETTER 22. FERRING PHARMACEUTICALS 4426 CLARIFICATION PVT.LTD. , LETTER 23. JOHNSON & JOHNSON LTD. 4922 CLARIFICAITON LETTER 24. RANBAXY LABORATORIES 4381 CLARIFICAITON LTD., LETTER 25. PROVIMI ANIMAL NUTTION NIL CLARIFICAITON INDIA PVT. LTD. LETTER 26. PFIZER LTD. CLARIFICAITON LETTER 27. INTERVET INDIA PVT. LTD. 10426 CLARIFICAITON LETTER 28. KENKO CORPORATION (I.B.O.) 7927 CLARIFICAITON LETTER