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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Glenmark Pharmaceuticals 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 (1)

44 FLUCONAZOLE USP (1)

45 FOSAPREPITANT DIMEGLUMINE (1)

46 FROVATRIPTAN SUCCINATE MONOHYDRATE (1)

47 GABAPENTIN ENACARBIL (1)

48 GLIMEPIRIDE USP (1)

49 HYDRALAZINE HYDROCHLORIDE USP (1)

50 IMIQUIMOD USP (1)

51 IRON SUCROSE (1)

52 ISAVUCONAZONIUM SULFATE (1)

53 ITRACONAZOLE USP (1)

54 IVACAFTOR (1)

55 LABETALOL HYDROCHLORIDE USP (1)

56 LACOSAMIDE USP (1)

57 LEVOCETIRIZINE DIHYDROCHLORIDE USP (1)

58 LIFITEGRAST (1)

59 LINAGLIPTIN (1)

60 LINEZOLID (1)

61 LINEZOLID D111 PROCESS (1)

62 LITHIUM CARBONATE USP (1)

63 LOMITAPIDE MESYLATE (1)

64 LORATADINE USP (1)

65 LULICONAZOLE (1)

66 LURASIDONE HYDROCHLORIDE (1)

67 MFG SITE FACILITIES OPERATING PROCEDURES AND PERSONEL FOR SATPUR NASIK INDIA SITE (1)

68 MILNACIPRAN HYDROCHLORIDE (1)

69 MIRABEGRON (1)

70 MOEXIPRIL HYDROCHLORIDE USP (1)

71 NINTEDANIB ESYLATE (1)

72 OLAPARIB (1)

73 OLMESARTAN MEDOXOMIL, USP (1)

74 OLOPATADINE HYDROCHLORIDE USP (1)

75 OMEPRAZOLE USP (1)

76 OSPEMIFENE (1)

77 OXCARBAZEPHIN USP (1)

78 PALIPERIDONE (1)

79 PALONOSETRON HYDROCHLORIDE (1)

80 PERINDOPRIL ERBUMINE (1)

81 PIRFENIDONE (1)

82 POTASSIUM CHLORIDE USP (1)

83 PRASUGREL HYDROCHLORIDE (1)

84 PREGABALIN (1)

85 PROGUANIL HYDROCHLORIDE USP (1)

86 RANOLAZINE (1)

87 RASAGILINE MESYLATE (1)

88 RILUZOLE USP (1)

89 RIVAROXABAN (1)

90 RIZATRIPTAN BENZOATE USP (1)

91 ROFLUMILAST USP (1)

92 ROPINIROLE HYDROCHLORIDE USP (1)

93 ROSUVASTATIN CALCIUM (1)

94 ROSUVASTATIN CALCIUM USP (1)

95 RUFINAMIDE (1)

96 SAXAGLIPTIN MONOHYDRATE (1)

97 SIMVASTATIN (1)

98 SITAGLIPTIN PHOSPHATE (1)

99 SITAGLIPTIN PHOSPHATE ANHYDROUS (1)

100 SITAGLIPTIN PHOSPHATE MONOHYDRATE (1)

101 SODIUM BICARBONATE USP (1)

102 SOLIFENACIN SUCCINATE (1)

103 SOLRIAMFETOL HYDROCHLORIDE (1)

104 SUCRALFATE USP (1)

105 SUCRALFATE USP (PROCESS-II) (1)

106 TADALAFIL (1)

107 TADALAFIL USP (D150 PROCESS) (1)

108 TAFAMIDIS (1)

109 TAFAMIDIS MEGLUMINE (1)

110 TAVABOROLE (1)

111 TAZAROTENE (1)

112 TELAPREVIR (1)

113 TELMISARTAN (1)

114 TELMISARTAN USP (1)

115 TELMISARTAN USP (D297 PROCESS) (1)

116 TERBINAFINE HYDROCHLORIDE USP (1)

117 TERBINAFINE HYDROCHLORIDE, USP (1)

118 TERIFLUNOMIDE (1)

119 TOFACITINIB CITRATE (1)

120 TOPIRAMATE USP (1)

121 TRANDOLAPRIL USP (1)

122 TRAZODONEL HYDROCHLORIDE USP (1)

123 TROSPIUM CHLORIDE USP (1)

124 URSODIOL USP (1)

125 VERAPAMIL HYDROCHLORIDE USP (1)

126 VILAZODONE HYDROCHLORIDE (1)

127 VORICONAZOLE USP (1)

128 ZOLMITRIPTAN USP (1)

129 ZOLPIDEM TARTRATE USP (2)

130 ZONISAMIDE (1)

131 ZONISAMIDE USP (D270 PROCESS) (1)

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01 GLENMARK GENERICS LTD (1)

02 GLENMARK LIFE SCIENCE LTD (1)

03 GLENMARK LIFE SCIENCES LTD (126)

04 GLENMARK PHARMACEUTICALS LTD (4)

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01 India (120)

02 United Kingdom (12)

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01 Active (125)

02 Inactive (7)

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01 Complete (77)

02 Blank (55)

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