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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Granules India Limited to the U.S. FDA. Original Data : FDA Website

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01 ACETAMINOPHEN USP (1)

02 ATAZANAVIR SULFATE (1)

03 BORTEZOMIB (1)

04 BUPROPION HYDROCHLORIDE USP (1)

05 CETIRIZINE HYDROCHLORIDE, USP (1)

06 COMPRESSO GGF 95 SA (GUAIFENESIN GRANULES 95%) (1)

07 COMPRESSO IBU 66S (1)

08 COMPRESSO IBU 85 PAR (IBUPROFEN GRANULES DC 85 %) (1)

09 COMPRESSO LSP 33.333 % (LOSARTAN POTASSIUM DIRECTLY COMPRESSIBLE GRANULES) (1)

10 COMPRESSO MF 95P (1)

11 COMPRESSO PAP 90 CPC (1)

12 COMPRESSO PAP 90 CPF (1)

13 COMPRESSO PAP 90 CPL (1)

14 DAPAGLIFLOZIN (1)

15 DASATINIB (1)

16 DASATINIB MONOHYDRATE (1)

17 DIMETHYL FUMARATE (1)

18 ELTROMBOPAG OLAMINE (1)

19 EMPAGLIFLOZIN (1)

20 ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE PELLETS (25.82% W/W) (1)

21 ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, USP (1)

22 FEXOFENADINE HYDROCHLORIDE, USP (1)

23 GUAIFENESIN USP (1)

24 LAPATINIB DITOSYLATE MONOHYDRATE (1)

25 LEVETIRACETAM USP (1)

26 LEVOCETIRIZINE DIHYDROCHLORIDE USP (1)

27 LINAGLIPTIN (1)

28 LOSARTAN POTASSIUM USP (1)

29 MELPHALAN HYDROCHLORIDE (1)

30 METFORMIN HYDROCHLORIDE USP (1)

31 METHOCARBAMOL USP (1)

32 METOPROLOL SUCCINATE MICROSPHERES 90% W/W (1)

33 METOPROLOL SUCCINATE USP (1)

34 NILOTINIB HYDROCHLORIDE MONOHYDRATE (1)

35 OLMESARTAN MEDOXOMIL USP (1)

36 OMEPRAZOLE MAGNESIUM USP (1)

37 Omeprazole USP (1)

38 PANTOPRAZOLE SODIUM SESQUIHYDRATE, USP (1)

39 PAZOPANIB HYDROCHLORIDE (1)

40 PENICILLAMINE, USP (1)

41 PIRFENIDONE (1)

42 PRAZOSIN HYDROCHLORIDE USP (1)

43 RIFAXIMIN (RSA CODE) (1)

44 RIFAXIMIN PH. EUR (1)

45 SORAFENIB TOSYLATE USP (1)

46 TRAZODONE HYDROCHLORIDE USP (1)

47 VIGABATRIN, USP (1)

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01 GRANULES INDIA LTD (45)

02 GRANULES INDIA LTD (UNIT-V) (1)

03 GRANULES PHARMACEUTICALS INC (1)

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01 India (42)

02 Blank (5)

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01 Active (47)

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01 Complete (23)

02 Blank (24)

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