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

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01 6-AMINOPENICILLANIC ACID (1)

02 ACALABRUTINIB (1)

03 AFATINIB DIMALEATE (1)

04 ALENDRONATE SODIUM USP (1)

05 ALOGLIPTIN BENZOATE (1)

06 APALUTAMIDE (1)

07 APIXABAN (1)

08 APREMILAST (1)

09 APREMILAST (FORM-B) (1)

10 ARIPIPRAZOLE USP (1)

11 ASENAPINE MALEATE (1)

12 AZILSARTAN MEDOXOMIL MONOPOTASSIUM (1)

13 AZITHROMYCIN DIHYDRATE USP (1)

14 AZITHROMYCIN DIHYDRATE USP (ADF PROCESS) (1)

15 AZITHROMYCIN MONOHYDRATE (1)

16 AZITHROMYCIN MONOHYDRATE USP (1)

17 AZITHROMYCIN MONOHYDRATE USP (PROCESS-II) (1)

18 BINIMETINIB (1)

19 BOSENTAN (1)

20 BOSUTINIB (1)

21 BREXPIPRAZOLE (1)

22 BUPROPION HYDROCHLORIDE USP (1)

23 CANAGLIFLOZIN (1)

24 CANDESARTAN CILEXETIL (1)

25 CANDESARTAN CILEXETIL USP (CND PROCESS) (1)

26 CELECOXIB USP (1)

27 CHLORDIAZEPOXIDE HYDROCHLORIDE USP (1)

28 CILOSTAZOL (1)

29 CLARITHROMYCIN (1)

30 CLARITHROMYCIN USP (1)

31 CLOFARABINE (1)

32 CLONIDINE HYDROCHLORIDE USP (1)

33 CLONIDINE USP (1)

34 CLOPIDOGREL BISULFATE USP (1)

35 DABIGATRAN ETEXILATE MESYLATE (1)

36 DAPAGLIFLOZIN (1)

37 DARIFENACIN HYDROBROMIDE (1)

38 DAROLUTAMIDE (1)

39 DASATINIB (1)

40 DEFERASIROX (1)

41 DEXLANSOPRAZOLE (1)

42 DONEPEZIL HYDROCHLORIDE MONOHYDRATE USP (1)

43 DRONEDARONE HYDROCHLORIDE USP (1)

44 DULOXETINE HYDROCHLORIDE USP (1)

45 DULOXETINE HYDROCHLORIDE USP (DUX PROCES) (1)

46 ELVITEGRAVIR (1)

47 EMPAGLIFLOZIN (1)

48 ERLOTINIB HYDROCHLORIDE (1)

49 ERYTHROMYCIN ETHYLSUCCINATE USP (1)

50 ERYTHROMYCIN USP (1)

51 ETORICOXIB (1)

52 FAMOTIDINE USP (1)

53 FEBUXOSTAT (1)

54 FELODIPINE USP (1)

55 FENOFIBRATE USP (1)

56 FENOFIBRIC ACID (1)

57 FENOFIBRIC ACID CHOLINE SALT (1)

58 FESOTERODINE FUMARATE (1)

59 FINGOLIMOD HYDROCHLORIDE USP (1)

60 FLUOXETINE HYDROCHLORIDE USP (1)

61 FLUPHENAZINE HYDROCHLORIDE USP (1)

62 GEFITINIB (1)

63 HYDROCHLOROTHIAZIDE USP (1)

64 IBRUTINIB (1)

65 ICATIBANT ACETATE (1)

66 ILOPERIDONE (1)

67 IRBESARTAN USP (1)

68 IVABRADINE HYDROCHLORIDE (1)

69 IVACAFTOR (1)

70 IVOSIDENIB (1)

71 LACOSAMIDE USP (1)

72 LAMOTRIGINE USP (1)

73 LAROTRECTINIB SULFATE (1)

74 LEFLUNOMIDE USP (1)

75 LENALIDOMIDE (FORM-H1) (1)

76 LINAGLIPTIN (1)

77 LINEZOLID USP (1)

78 LINEZOLID USP (FORM-I) (1)

79 LINEZOLID USP (FORM-II) (1)

80 LOSARTAN POTASSIUM USP (1)

81 LOVASTATIN USP (1)

82 LURASIDONE HYDROCHLORIDE (1)

83 Levetiracetam (1)

84 MACITENTAN (1)

85 MEMANTINE HYDROCHLORIDE USP (1)

86 MEPROBAMATE USP (1)

87 METHOTREXATE SODIUM (1)

88 METOPROLOL SUCCINATE USP (1)

89 METOPROLOL TARTRATE USP (1)

90 MEXILETINE HYDROCHLORIDE USP (1)

91 MODAFINIL USP (1)

92 NELARABINE (1)

93 NISOLDIPINE (1)

94 NITROFURANTOIN MACROCRYSTAL USP (1)

95 NITROFURANTOIN MONOHYDRATE USP (1)

96 O-DESMETHYL VENLAFAXINE (1)

97 O-DESMETHYL VENLAFAXINE SUCCINATE MONOHYDRATE USP (1)

98 O-DESMETHYL VENLAFAXINE USP (1)

99 OBETICHOLIC ACID (1)

100 OCTREOTIDE ACETATE USP (1)

101 OLAPARIB (1)

102 OLMESARTAN MEDOXOMIL USP (1)

103 OSIMERTINIB MESYLATE (1)

104 PALBOCICLIB (1)

105 PENCICLOVIR (1)

106 PENTOSAN POLYSULFATE SODIUM (1)

107 PIRFENIDONE (1)

108 PLERIXAFOR (1)

109 PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP (1)

110 PRASUGREL HYDROCHLORIDE (1)

111 PREGABALIN USP (1)

112 PRUCALOPRIDE SUCCINATE (1)

113 QUETIAPINE FUMARATE USP (1)

114 RABEPRAZOLE SODIUM (1)

115 RIOCIGUAT (1)

116 RIVAROXABAN (1)

117 RIVASTIGMINE TARTRATE USP (1)

118 RIVASTIGMINE USP (1)

119 ROPINIROLE HYDROCHLORIDE USP (1)

120 SACUBITRIL VALSARTAN TRISODIUM HEMIPENTAHYDRATE (1)

121 SELEXIPAG (1)

122 SILODOSIN (1)

123 SOFOSBUVIR (1)

124 SOLIFENACIN SUCCINATE (1)

125 SORAFENIB TOSYLATE (1)

126 SORAFENIB TOSYLATE (FORM-I) (1)

127 TADALAFIL USP (1)

128 TEGASEROD MALEATE (1)

129 TELMISARTAN USP (1)

130 TENOFOVIR ALAFENAMIDE HEMIFUMARATE (1)

131 TERIFLUNOMIDE (1)

132 TERIPARATIDE (1)

133 THEOPHYLLINE (ANHYDROUS) USP (1)

134 TICAGRELOR (1)

135 TOPIRAMATE (1)

136 TOPIRAMATE USP (1)

137 VALSARTAN USP (PROCESS II) (1)

138 VALSARTAN USP (PROCESS III) (1)

139 VARDENAFIL HYDROCHLORIDE USP (1)

140 VENETOCLAX (1)

141 VENLAFAXINE HYDROCHLORIDE (2)

142 VENLAFAXINE HYDROCHLORIDE USP (1)

143 VILAZODONE HYDROCHLORIDE (1)

144 VILAZODONE HYDROCHLORIDE (FORM-IV) (1)

145 VORTIOXETINE HYDROBROMIDE (1)

146 Valsartan USP ( PROCESS I) (1)

147 WARFARIN SODIUM AMORPHOUS USP (1)

148 WARFARIN SODIUM CLATHRATE USP (1)

149 ZOLMITRIPTAN USP (1)

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01 ALEMBIC LTD (2)

02 ALEMBIC LTD API DIV (2)

03 ALEMBIC PHARMACEUTICALS LTD (145)

04 ALEMBIC PHARMACEUTICALS LTD API DIV (1)

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01 India (150)

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01 Active (132)

02 Inactive (18)

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01 Complete (95)

02 Blank (55)

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ALEMBIC LTD API DIV
Inactive
22512
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2009-02-02
II
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31848
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2017-07-18
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2017-06-30
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ALEMBIC PHARMACEUTICA...
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20651
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2007-06-25
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ALEMBIC PHARMACEUTICA...
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30093
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2016-02-08
2015-12-18
2015-12-30
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2015-12-18
2014-12-24
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2017-10-23
2017-10-31
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ALEMBIC PHARMACEUTICA...
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2019-03-29
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2009-11-18
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