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

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01 ADAPALENE USP (1)

02 ALFUZOSIN HYDROCHLORIDE USP (1)

03 ALOGLIPTIN BENZOATE (1)

04 AMIODARONE HYDROCHLORIDE USP (1)

05 APIXABAN (1)

06 APREMILAST (1)

07 APREPITANT USP (1)

08 APREPITANT USP (BO74 PROCESS) (1)

09 ARFORMOTEROL TARTRATE (1)

10 ATOMOXETINE HYDROCHLORIDE USP (1)

11 ATOVAQUONE USP (D144 PROCESS) (1)

12 ATOVAQUONE, USP (1)

13 AZELAIC ACID (1)

14 BOSENTAN (1)

15 BRIVARACETAM (1)

16 BUPROPION HYDROCHLORIDE USP (1)

17 CHOLINE FENOFIBRATE (1)

18 CILOSTAZOL USP (1)

19 DABIGATRAN ETEXILATE MESYLATE (1)

20 DABIGATRAN ETEXILATE MESYLATE(PROCESS II) (1)

21 DACLATASVIR DIHYDROCHLORIDE (1)

22 DAPAGLIFLOZIN AMORPHOUS (1)

23 DARIFENACIN HYDROBROMIDE (1)

24 DEFERASIROX (1)

25 DEOXYCHOLIC ACID USP (1)

26 DESLORATADINE (1)

27 DIMETHYL FUMARATE (1)

28 DIPYRIDAMOLE USP (1)

29 DIROXIMEL FUMARATE (1)

30 DRONEDARONE HYDROCHLORIDE USP (1)

31 EFINACONAZOLE (1)

32 ELAGOLIX SODIUM (1)

33 ENZALUTAMIDE (1)

34 ESOMEPRAZOLE (1)

35 ESOMEPRAZOLE MAGNESIUM DIHYDRATE (1)

36 ESOMEPRAZOLE MAGNESIUM DIHYDRATE USP (1)

37 ESOMEPRAZOLE POTASSIUM (1)

38 ESZOPICLONE USP (1)

39 EZETIMIBE (D067 PROCESS) (1)

40 EZETIMIBE (PROCESS I) (1)

41 EZETIMIBE, USP (PROCESS II) (1)

42 FINGOLIMOD HYDROCHLORIDE USP (1)

43 FLUCONAZOLE USP (1)

44 FOSAPREPITANT DIMEGLUMINE (1)

45 FROVATRIPTAN SUCCINATE MONOHYDRATE (1)

46 GABAPENTIN ENACARBIL (1)

47 GLIMEPIRIDE USP (1)

48 HYDRALAZINE HYDROCHLORIDE USP (1)

49 IMIQUIMOD USP (1)

50 IRON SUCROSE (1)

51 ISAVUCONAZONIUM SULFATE (1)

52 ITRACONAZOLE USP (1)

53 IVACAFTOR (1)

54 LABETALOL HYDROCHLORIDE USP (1)

55 LACOSAMIDE USP (1)

56 LEVOCETIRIZINE DIHYDROCHLORIDE USP (1)

57 LIFITEGRAST (1)

58 LINAGLIPTIN (1)

59 LINEZOLID (1)

60 LINEZOLID D111 PROCESS (1)

61 LITHIUM CARBONATE USP (1)

62 LOMITAPIDE MESYLATE (1)

63 LORATADINE USP (1)

64 LULICONAZOLE (1)

65 LURASIDONE HYDROCHLORIDE (1)

66 MILNACIPRAN HYDROCHLORIDE (1)

67 MIRABEGRON (1)

68 MOEXIPRIL HYDROCHLORIDE USP (1)

69 NINTEDANIB ESYLATE (1)

70 OLAPARIB (1)

71 OLMESARTAN MEDOXOMIL, USP (1)

72 OLOPATADINE HYDROCHLORIDE USP (1)

73 OMEPRAZOLE USP (1)

74 OSPEMIFENE (1)

75 OXCARBAZEPHIN USP (1)

76 PALIPERIDONE (1)

77 PERINDOPRIL ERBUMINE (1)

78 PIRFENIDONE (1)

79 POTASSIUM CHLORIDE USP (1)

80 PRASUGREL HYDROCHLORIDE (1)

81 PREGABALIN (1)

82 PROGUANIL HYDROCHLORIDE USP (1)

83 RANOLAZINE (1)

84 RASAGILINE MESYLATE (1)

85 RILUZOLE USP (1)

86 RIVAROXABAN (1)

87 RIZATRIPTAN BENZOATE USP (1)

88 ROFLUMILAST USP (1)

89 ROPINIROLE HYDROCHLORIDE USP (1)

90 ROSUVASTATIN CALCIUM (1)

91 ROSUVASTATIN CALCIUM USP (1)

92 RUFINAMIDE (1)

93 SAXAGLIPTIN MONOHYDRATE (1)

94 SITAGLIPTIN PHOSPHATE (1)

95 SITAGLIPTIN PHOSPHATE ANHYDROUS (1)

96 SITAGLIPTIN PHOSPHATE MONOHYDRATE (1)

97 SODIUM BICARBONATE USP (1)

98 SOLIFENACIN SUCCINATE (1)

99 SOLRIAMFETOL HYDROCHLORIDE (1)

100 SUCRALFATE USP (1)

101 SUCRALFATE USP (PROCESS-II) (1)

102 TADALAFIL (1)

103 TADALAFIL USP (D150 PROCESS) (1)

104 TAFAMIDIS (1)

105 TAFAMIDIS MEGLUMINE (1)

106 TAVABOROLE (1)

107 TAZAROTENE (1)

108 TELAPREVIR (1)

109 TELMISARTAN USP (1)

110 TELMISARTAN USP (D297 PROCESS) (1)

111 TERBINAFINE HYDROCHLORIDE USP (1)

112 TERBINAFINE HYDROCHLORIDE, USP (1)

113 TERIFLUNOMIDE (1)

114 TOFACITINIB CITRATE (1)

115 TOPIRAMATE USP (1)

116 TRANDOLAPRIL USP (1)

117 TRAZODONEL HYDROCHLORIDE USP (1)

118 TROSPIUM CHLORIDE USP (1)

119 URSODIOL USP (1)

120 VERAPAMIL HYDROCHLORIDE USP (1)

121 VILAZODONE HYDROCHLORIDE (1)

122 VORICONAZOLE USP (1)

123 ZOLMITRIPTAN USP (1)

124 ZOLPIDEM TARTRATE USP (2)

125 ZONISAMIDE (1)

126 ZONISAMIDE USP (D270 PROCESS) (1)

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01 GLENMARK LIFE SCIENCE LTD (1)

02 GLENMARK LIFE SCIENCES LTD (126)

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01 India (115)

02 United Kingdom (12)

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01 Active (125)

02 Inactive (2)

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01 Complete (77)

02 Blank (50)

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