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

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01 (S)- METHYL-3- (4-BIS(2-HYDROXYETHYL) AMINO) PHENYL) -2 - (TERT- BUTOXYCARBONYLAMINO) PROPANOATE (1)

02 4'-ACETYLOXY 2, 4-DIFLUOROBIPHENYL (1)

03 ACAMPROSATE CALCIUM USP (1)

04 ACETAZOLAMIDE USP (1)

05 ADENOSINE USP (1)

06 AMINOCAPROIC ACID USP (1)

07 AMIODARONE HYDROCHLORIDE USP (1)

08 ANASTROZOLE USP (1)

09 ARGATROBAN USP (1)

10 ARSENIC TRIOXIDE (1)

11 ATAZANAVIR SULFATE USP (1)

12 BENDAMUSTINE HYDROCHLORIDE USP (1)

13 BENZPHETAMINE HYDROCHLORIDE USP (1)

14 BEXAROTENE (1)

15 BICALUTAMIDE USP (1)

16 BUSPIRONE HYDROCHLORIDE USP (1)

17 BUSULFAN USP (1)

18 CARMUSTINE USP (1)

19 CHLORPROMAZINE HYDROCHLORIDE USP (1)

20 CIDOFOVIR USP (1)

21 CLOFARABINE (1)

22 COLESEVELAM HYDROCHLORIDE (1)

23 CYCLOPHOSPHAMIDE USP (2)

24 DARIFENACIN HYDROBROMIDE (1)

25 DECITABINE MONOHYDRATE (1)

26 DEFERIPRONE (1)

27 DEXMEDETOMIDINE HYDROCHLORIDE USP (1)

28 DOCETAXEL TRIHYDRATE USP (PROCESS II) (1)

29 DOCETAXEL USP (1)

30 DOFETILIDE USP (1)

31 DOLASETRON MESYLATE USP (1)

32 DOLUTEGRAVIR SODIUM (1)

33 DRONEDARONE HYDROCHLORIDE (1)

34 EFAVIRENZ (ALTERNATE PROCESS) (1)

35 EFAVIRENZ USP (1)

36 EMTRICITABINE (1)

37 ENOXAPARIN SODIUM USP (1)

38 EPL 001 (1)

39 ERIBULIN MESYLATE (1)

40 ESOMEPRAZOLE SODIUM (1)

41 ESOMEPRAZOLE SODIUM (PROCESS II) (1)

42 ESZOPICLONE USP (1)

43 ETHACRYNIC ACID USP (1)

44 ETODOLAC USP (1)

45 FEBUXOSTAT (1)

46 FELBAMATE USP (1)

47 FELODIPINE USP (1)

48 FENOPROFEN CALCIUM USP (1)

49 FINGOLIMOD HYDROCHLORIDE USP (1)

50 FLECAINIDE ACETATE USP (1)

51 FOSCARNET SODIUM USP (1)

52 GEMCITABINE HYDROCHLORIDE USP (1)

53 GEMCITABINE HYDROCHLORIDE USP (PROCESS II) (1)

54 IBANDRONATE SODIUM MONOHYDRATE (1)

55 IBUTILIDE FUMARATE USP (1)

56 IRINOTECAN HYDROCHLORIDE USP (1)

57 IRON SUCROSE COMPLEX SOLUTION (1)

58 ISOPROTERENOL HYDROCHLORIDE USP (1)

59 ISOSULFAN BLUE (1)

60 KETOROLAC TROMETHAMINE USP (1)

61 LEFLUNOMIDE USP (1)

62 LISINOPRIL USP (1)

63 MEFLOQUINE HYDROCHLORIDE USP (1)

64 MELPHALAN HYDROCHLORIDE (1)

65 MEMANTINE HYDROCHLORIDE USP (1)

66 METOCLOPRAMIDE HYDROCHLORIDE USP (1)

67 MIDODRINE HYDROCHLORIDE USP (1)

68 MILRINONE USP (1)

69 MYCOPHENOLATE MOFETIL USP (1)

70 MYCOPHENOLATE SODIUM USP (1)

71 NEOSTIGMINE METHYLSULFATE USP (1)

72 NISOLDIPINE (1)

73 OLSALAZINE SODIUM (1)

74 OLSALAZINE SODIUM (PROCESS II) (1)

75 OXALIPLATIN USP (1)

76 PALIPERIDONE USP (1)

77 PALONOSETRON HYDROCHLORIDE USP (1)

78 PANTOPRAZOLE SODIUM USP (1)

79 PEMETREXED DISODIUM HEMIPENTAHYDRATE (1)

80 PENTAMIDINE ISETHIONATE USP (1)

81 PERPHENAZINE USP (1)

82 PHYTONADIONE USP (1)

83 PROCHLORPERAZINE EDISYLATE USP (1)

84 PROMETHAZINE HYDROCHLORIDE USP (1)

85 PROPAFENONE HYDROCHLORIDE USP (1)

86 PROPOFOL USP (1)

87 PROTRIPTYLINE HYDROCHLORIDE USP (1)

88 RALTEGRAVIR POTASSIUM (1)

89 RITONAVIR USP (1)

90 RITONAVIR USP (PROCESS II) (1)

91 RIVASTIGMINE TARTRATE (1)

92 RIZATRIPTAN BENZOATE USP (1)

93 ROPIVACAINE HYDROCHLORIDE USP (PROCESS II) (1)

94 SEVELAMER CARBONATE (E SUB) (1)

95 SEVELAMER CARBONATE (FOR POWDER FORMULATION) (1)

96 SEVELAMER CARBONATE (PROCESS II) (1)

97 SEVELAMER HYDROCHLORIDE (PROCESS II) (1)

98 SEVELAMER HYDROCHLORIDE (PROCESS-I) (1)

99 SM ARG-I (1)

100 SODIUM CARBONATE MONOHYDRATE USP-NF (1)

101 SODIUM FERRIC GLUCONATE COMPLEX (1)

102 SODIUM NITROPRUSSIDE USP (1)

103 SULFAMETHOXAZOLE USP (2)

104 TENOFOVIR ALAFENAMIDE FUMARATE (1)

105 TENOFOVIR DISOPROXIL FUMARATE (2)

106 TERIFLUNOMIDE (1)

107 THIAMINE HYDROCHLORIDE USP (1)

108 THIOTEPA USP (1)

109 TOLTERODINE TARTRATE (1)

110 TOPOTECAN HYDROCHLORIDE (1)

111 TREPROSTINIL (1)

112 TRIENTINE HYDROCHLORIDE USP (1)

113 TRIMETHOBENZAMIDE HYDROCHLORIDE USP (1)

114 ZILEUTON USP (1)

115 ZOLEDRONIC ACID USP (1)

116 ZOLMITRIPTAN (1)

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01 Active (101)

02 Inactive (18)

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01 Complete (66)

02 Blank (53)

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