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

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01 ADAPALENE USP (1)

02 BESIFLOXACIN HYDROCHLORIDE (1)

03 BRIMONIDINE TARTRATE USP (1)

04 BRIVARACETAM (1)

05 BUSPIRONE HYDROCHLORIDE USP (1)

06 CARBIDOPA USP (1)

07 CARBIMAZOLE (1)

08 CHLORPROMAZINE HYDROCHLORIDE USP (1)

09 CHLORTHALIDONE USP (1)

10 CYSTEAMINE BITARTRATE (MONOHYDRATE) (1)

11 DAPOXETINE HYDROCHLORIDE (1)

12 DEUTETRABENAZINE (1)

13 DEXMEDETOMIDINE HYDROCHLORIDE USP (1)

14 DIVALPROEX SODIUM USP (1)

15 DOCOSANOL (1)

16 EFINACONAZOLE [ROUTE CODE 'EC'] (1)

17 ELIGLUSTAT TARTRATE (1)

18 ELIGLUSTAT TARTRATE (PREMIX) (1)

19 ESKETAMINE HYDROCHLORIDE (1)

20 FENFLURAMINE HYDROCHLORIDE (1)

21 FESOTERODINE FUMARATE (1)

22 FLUCYTOSINE USP (1)

23 FOSCARNET SODIUM USP (1)

24 GEMIFLOXACIN MESYLATE USP (1)

25 IVABRADINE HYDROCHLORIDE HEMIPENTAHYDRATE (1)

26 KETAMINE HYDROCHLORIDE USP (1)

27 LERCANIDIPINE HYDROCHLORIDE (AMORPHOUS) (1)

28 LERCANIDIPINE HYDROCHLORIDE (FORM-I) (1)

29 LEVODOPA USP (1)

30 LOMITAPIDE MESYLATE (FORM-M) (1)

31 LULICONAZOLE (1)

32 LUMACAFTOR (1)

33 LUMATEPERONE TOSYLATE (1)

34 MESALAMINE USP (1)

35 METHIMAZOLE USP (1)

36 MIRTAZAPINE ANHYDROUS USP (1)

37 MIRTAZAPINE USP [ROUTE CODE - MZ) (1)

38 NETARSUDIL DIMESYLATE (1)

39 NITROFURANTOIN ANHYDROUS USP (1)

40 NITROFURANTOIN ANHYDROUS USP (MACROCRYSTALS) (1)

41 NITROFURANTOIN HYDROUS USP (1)

42 OSPEMIFENE (1)

43 OZANIMOD HYDROCHLORIDE (1)

44 OZENOXACIN (1)

45 PENCICLOVIR (1)

46 PYRIDOSTIGMINE BROMIDE USP (1)

47 RALTEGRAVIR POTASSIUM USP (1)

48 ROXADUSTAT (1)

49 SELENIOUS ACID USP (1)

50 SELEXIPAG (FORM-I) (1)

51 SELEXIPAG (FORM-III) (1)

52 SELEXIPAG (FORM-P) (1)

53 SIPONIMOD FUMARIC ACID (1)

54 TIGECYCLINE USP (FORM-II) [ROUTE CODE 'TY'] (1)

55 TRIFAROTENE (1)

56 VALGANCICLOVIR HYDROCHLORIDE USP (1)

57 VARENICLINE TARTRATE (1)

58 VILOXAZINE HYDROCHLORIDE (2)

59 VONOPRAZAN FUMARATE (1)

60 VORICONAZOLE CAMPHOR SULFONATE (1)

61 VORICONAZOLE USP (1)

62 ZONISAMIDE USP (1)

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02 MAITHRI LABORATORIES PRIVATE LTD (13)

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01 Active (63)

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01 Complete (22)

02 Blank (41)

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