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

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01 12-HYDROXY-5-METHYLPYRIDINE

02 1ALENDRONATE SODIUM USP

03 1ALISKIREN HEMIFUMARATE

04 1APIXABAN

05 1APREMILAST

06 1APREPITANT USP

07 1ARIPIPRAZOLE USP

08 1ATORVASTATIN CALCIUM (AMORPHOUS)

09 1AZILSARTAN MEDOXOMIL POTASSIUM

10 1AZITHROMYCIN DIHYDRATE USP

11 1AZITHROMYCIN MONOHYDRATE USP

12 1BOSENTAN MONOHYDRATE

13 1BREXPIPRAZOLE

14 1BUPROPION HYDROBROMIDE

15 1BUPROPION HYDROCHLORIDE USP

16 1CANDESARTAN CILEXETIL USP

17 1CARBAMAZEPINE USP

18 1CETIRIZINE DIHYDROCHLORIDE USP

19 1CINACALCET HYDROCHLORIDE

20 1CITALOPRAM HYDROBROMIDE (DGR) USP

21 1CITALOPRAM HYDROBROMIDE USP

22 1CLOPIDOGREL BISULFATE USP

23 1CYCLOBENZAPRINE HYDROCHLORIDE

24 1DABIGATRAN ETEXILATE MESYLATE

25 1DALFAMPRIDINE USP

26 1DARIFENACIN HYDROBROMIDE

27 1DEFERASIROX

28 1DEXLANSOPRAZOLE

29 1DIETHYL-3-PYRIDYLBORANE

30 1DONEPEZIL HYDROCHLORIDE USP (ANHYDROUS FORM-1)

31 1DULOXETINE HYDROCHLORIDE

32 1ENTACAPONE

33 1EPROSARTAN MESYLATE

34 1ESCITALOPRAM OXALATE USP

35 1ESCITALOPRAM OXALATE USP (ESP PROCESS)

36 1ESLICARBAZEPINE ACETATE

37 1ESOMEPRAZOLE MAGNESIUM

38 1ESOMEPRAZOLE MAGNESIUM (AMORPHOUS) USP

39 1ESOMEPRAZOLE MAGNESIUM AMORPHOUS-USP

40 1ESOMEPRAZOLE MAGNESIUM DIHYDRATE

41 1ESOMEPRAZOLE MAGNESIUM TRIHYDRATE USP

42 2ESOMEPRAZOLE SODIUM

43 1FEBUXOSTAT

44 1FEXOFENADINE HYDROCHLORIDE

45 1GALANTAMINE HYDROBROMIDE

46 1GUANFACINE HYDROCHLORIDE USP

47 1HISTAMINE DIHYDROCHLORIDE

48 1IRBESARTAN USP

49 1LACOSAMIDE

50 1LAMOTRIGINE USP

51 1LANSOPRAZOLE USP

52 1LEVETIRACETAM USP

53 1LEVOCETIRIZINE DIHYDROCHLORIDE USP

54 1LINEZOLID FORM 1

55 1LOSARTAN POTASSIUM USP

56 1LURASIDONE HYDROCHLORIDE

57 1MECLIZINE HYDROCHLORIDE USP

58 1MIRABEGRON

59 1NIACIN USP

60 1OLANZAPINE USP

61 1OLANZAPINE USP (FORM-I)

62 1OLMESARTAN MEDOXOMIL USP

63 1OXCARBAZEPINE CO-PRECIPITATE

64 1OXCARBAZEPINE USP

65 1PALIPERIDONE

66 1PALIPERIDONE PALMITATE

67 1PANTOPRAZOLE SODIUM USP

68 1PAROXETINE HYDROCHLORIDE-USP (HEMIHYDRATE)

69 1PERPHENAZINE USP

70 1PINAVERIUM BROMIDE

71 1PIRFENIDONE

72 1QUETIAPINE FUMARATE

73 1QUETIAPINE FUMARATE USP

74 1RABEPRAZOLE SODIUM-USP (HYDRATE, AMORPHOUS)

75 1RANOLAZINE

76 1REPAGLINIDE USP

77 1RISEDRONATE SODIUM HEMIPENTAHYDRATE-USP

78 1RISPERIDONE-USP

79 1RIVAROXABAN

80 1RIVASTIGMINE TARTRATE

81 1RIVASTIGMINE USP

82 1RIZATRIPTAN BENZOATE USP

83 1ROPIVACAINE HYDROCHLORIDE USP

84 1ROSUVASTATIN CALCIUM AMORPHOUS

85 1SIMVASTATIN USP

86 1SITAGLIPTIN PHOSPHATE USP

87 1SOLIFENACIN SUCCINATE

88 1STANNOUS GLUCONATE COMPLEX

89 1STERILE EMPTY VIALS

90 1STERILE EVACUATED VIALS

91 1TADALAFIL-USP

92 1TELMISARTAN

93 1TERAZOSIN HYDROCHLORIDE

94 1TICAGRELOR

95 1TRAMADOL HYDROCHLORIDE USP

96 1VALACYCLOVIR HYDROCHLORIDE

97 1VALSARTAN USP

98 1VARENICLINE TARTRATE

99 1VILAZODONE HYDROCHLORIDE

100 1VILDAGLIPTIN

101 1VORICONAZOLE USP

102 1ZIPRASIDONE HYDROCHLORIDE USP

103 1ZOLEDRONIC ACID

104 1ZOLMITRIPTAN USP

105 1ZOPICLONE

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