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

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01 1ADAPALENE USP

02 1ALFUZOSIN HYDROCHLORIDE USP

03 1ALOGLIPTIN BENZOATE

04 1AMIODARONE HYDROCHLORIDE USP

05 1APIXABAN

06 1APREMILAST

07 1APREPITANT USP

08 1APREPITANT USP (BO74 PROCESS)

09 1ARFORMOTEROL TARTRATE

10 1ATOMOXETINE HYDROCHLORIDE USP

11 1ATOVAQUONE USP (D144 PROCESS)

12 1ATOVAQUONE, USP

13 1AZELAIC ACID

14 1BOSENTAN

15 1BRIVARACETAM

16 1BUPROPION HYDROCHLORIDE USP

17 1CHOLINE FENOFIBRATE

18 1CILOSTAZOL USP

19 1DABIGATRAN ETEXILATE MESYLATE

20 1DABIGATRAN ETEXILATE MESYLATE(PROCESS II)

21 1DACLATASVIR DIHYDROCHLORIDE

22 1DAPAGLIFLOZIN AMORPHOUS

23 1DARIFENACIN HYDROBROMIDE

24 1DEFERASIROX

25 1DEOXYCHOLIC ACID USP

26 1DESLORATADINE

27 1DIMETHYL FUMARATE

28 1DIPYRIDAMOLE USP

29 1DIROXIMEL FUMARATE

30 1DRONEDARONE HYDROCHLORIDE USP

31 1EFINACONAZOLE

32 1ELAGOLIX SODIUM

33 1ENZALUTAMIDE

34 1ESOMEPRAZOLE

35 1ESOMEPRAZOLE MAGNESIUM DIHYDRATE

36 1ESOMEPRAZOLE MAGNESIUM DIHYDRATE USP

37 1ESOMEPRAZOLE POTASSIUM

38 1ESZOPICLONE USP

39 1EZETIMIBE (D067 PROCESS)

40 1EZETIMIBE (PROCESS I)

41 1EZETIMIBE, USP (PROCESS II)

42 1FINGOLIMOD HYDROCHLORIDE USP

43 1FLUCONAZOLE

44 1FLUCONAZOLE USP

45 1FOSAPREPITANT DIMEGLUMINE

46 1FROVATRIPTAN SUCCINATE MONOHYDRATE

47 1GABAPENTIN ENACARBIL

48 1GLIMEPIRIDE USP

49 1HYDRALAZINE HYDROCHLORIDE USP

50 1IMIQUIMOD USP

51 1IRON SUCROSE

52 1ISAVUCONAZONIUM SULFATE

53 1ITRACONAZOLE USP

54 1IVACAFTOR

55 1LABETALOL HYDROCHLORIDE USP

56 1LACOSAMIDE USP

57 1LEVOCETIRIZINE DIHYDROCHLORIDE USP

58 1LIFITEGRAST

59 1LINAGLIPTIN

60 1LINEZOLID

61 1LINEZOLID D111 PROCESS

62 1LITHIUM CARBONATE USP

63 1LOMITAPIDE MESYLATE

64 1LORATADINE USP

65 1LULICONAZOLE

66 1LURASIDONE HYDROCHLORIDE

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

68 1MILNACIPRAN HYDROCHLORIDE

69 1MIRABEGRON

70 1MOEXIPRIL HYDROCHLORIDE USP

71 1NINTEDANIB ESYLATE

72 1OLAPARIB

73 1OLMESARTAN MEDOXOMIL, USP

74 1OLOPATADINE HYDROCHLORIDE USP

75 1OMEPRAZOLE USP

76 1OSPEMIFENE

77 1OXCARBAZEPHIN USP

78 1PALIPERIDONE

79 1PALONOSETRON HYDROCHLORIDE

80 1PERINDOPRIL ERBUMINE

81 1PIRFENIDONE

82 1POTASSIUM CHLORIDE USP

83 1PRASUGREL HYDROCHLORIDE

84 1PREGABALIN

85 1PROGUANIL HYDROCHLORIDE USP

86 1PROPRANOLOL HYDROCHLORIDE USP

87 1RANOLAZINE

88 1RASAGILINE MESYLATE

89 1RILUZOLE USP

90 1RIVAROXABAN

91 1RIZATRIPTAN BENZOATE USP

92 1ROFLUMILAST USP

93 1ROPINIROLE HYDROCHLORIDE USP

94 1ROSUVASTATIN CALCIUM

95 1ROSUVASTATIN CALCIUM USP

96 1RUFINAMIDE

97 1SAXAGLIPTIN MONOHYDRATE

98 1SIMVASTATIN

99 1SITAGLIPTIN PHOSPHATE

100 1SITAGLIPTIN PHOSPHATE ANHYDROUS

101 1SITAGLIPTIN PHOSPHATE MONOHYDRATE

102 1SODIUM BICARBONATE USP

103 1SOLIFENACIN SUCCINATE

104 1SOLRIAMFETOL HYDROCHLORIDE

105 1SUCRALFATE USP

106 1SUCRALFATE USP (PROCESS-II)

107 1TADALAFIL

108 1TADALAFIL USP (D150 PROCESS)

109 1TAFAMIDIS

110 1TAFAMIDIS MEGLUMINE

111 1TAVABOROLE

112 1TAZAROTENE

113 1TELAPREVIR

114 1TELMISARTAN

115 1TELMISARTAN USP

116 1TELMISARTAN USP (D297 PROCESS)

117 1TERBINAFINE HYDROCHLORIDE USP

118 1TERBINAFINE HYDROCHLORIDE, USP

119 1TERIFLUNOMIDE

120 1TOFACITINIB CITRATE

121 1TOPIRAMATE USP

122 1TRANDOLAPRIL USP

123 1TRAZODONEL HYDROCHLORIDE USP

124 1TROSPIUM CHLORIDE USP

125 1URSODIOL USP

126 1VERAPAMIL HYDROCHLORIDE USP

127 1VILAZODONE HYDROCHLORIDE

128 1VORICONAZOLE USP

129 1ZOLMITRIPTAN USP

130 2ZOLPIDEM TARTRATE USP

131 1ZONISAMIDE

132 1ZONISAMIDE USP (D270 PROCESS)

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