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

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01 2-HYDROXY-5-METHYLPYRIDINE (1)

02 ALENDRONATE SODIUM USP (1)

03 ALISKIREN HEMIFUMARATE (1)

04 APIXABAN (1)

05 APREMILAST (1)

06 APREPITANT USP (1)

07 ARIPIPRAZOLE USP (1)

08 ATORVASTATIN CALCIUM (AMORPHOUS) (1)

09 AZILSARTAN MEDOXOMIL POTASSIUM (1)

10 AZITHROMYCIN DIHYDRATE USP (1)

11 AZITHROMYCIN MONOHYDRATE USP (1)

12 BOSENTAN MONOHYDRATE (1)

13 BREXPIPRAZOLE (1)

14 BUPROPION HYDROBROMIDE (1)

15 BUPROPION HYDROCHLORIDE USP (1)

16 CANDESARTAN CILEXETIL USP (1)

17 CARBAMAZEPINE USP (1)

18 CETIRIZINE DIHYDROCHLORIDE USP (1)

19 CINACALCET HYDROCHLORIDE (1)

20 CITALOPRAM HYDROBROMIDE (DGR) USP (1)

21 CITALOPRAM HYDROBROMIDE USP (1)

22 CLOPIDOGREL BISULFATE USP (1)

23 CYCLOBENZAPRINE HYDROCHLORIDE (1)

24 DABIGATRAN ETEXILATE MESYLATE (1)

25 DALFAMPRIDINE USP (1)

26 DARIFENACIN HYDROBROMIDE (1)

27 DEFERASIROX (1)

28 DEXLANSOPRAZOLE (1)

29 DIETHYL-3-PYRIDYLBORANE (1)

30 DONEPEZIL HYDROCHLORIDE USP (ANHYDROUS FORM-1) (1)

31 DULOXETINE HYDROCHLORIDE (1)

32 ENTACAPONE (1)

33 EPROSARTAN MESYLATE (1)

34 ESCITALOPRAM OXALATE USP (1)

35 ESCITALOPRAM OXALATE USP (ESP PROCESS) (1)

36 ESLICARBAZEPINE ACETATE (1)

37 ESOMEPRAZOLE MAGNESIUM (1)

38 ESOMEPRAZOLE MAGNESIUM (AMORPHOUS) USP (1)

39 ESOMEPRAZOLE MAGNESIUM AMORPHOUS-USP (1)

40 ESOMEPRAZOLE MAGNESIUM DIHYDRATE (1)

41 ESOMEPRAZOLE MAGNESIUM TRIHYDRATE USP (1)

42 ESOMEPRAZOLE SODIUM (2)

43 FEBUXOSTAT (1)

44 FEXOFENADINE HYDROCHLORIDE (1)

45 GALANTAMINE HYDROBROMIDE (1)

46 GUANFACINE HYDROCHLORIDE USP (1)

47 HISTAMINE DIHYDROCHLORIDE (1)

48 IRBESARTAN USP (1)

49 LACOSAMIDE (1)

50 LAMOTRIGINE USP (1)

51 LANSOPRAZOLE USP (1)

52 LEVETIRACETAM USP (1)

53 LEVOCETIRIZINE DIHYDROCHLORIDE USP (1)

54 LINEZOLID FORM 1 (1)

55 LOSARTAN POTASSIUM USP (1)

56 LURASIDONE HYDROCHLORIDE (1)

57 MECLIZINE HYDROCHLORIDE USP (1)

58 MIRABEGRON (1)

59 NIACIN USP (1)

60 OLANZAPINE USP (1)

61 OLANZAPINE USP (FORM-I) (1)

62 OLMESARTAN MEDOXOMIL USP (1)

63 OXCARBAZEPINE CO-PRECIPITATE (1)

64 OXCARBAZEPINE USP (1)

65 PALIPERIDONE (1)

66 PALIPERIDONE PALMITATE (1)

67 PANTOPRAZOLE SODIUM USP (1)

68 PAROXETINE HYDROCHLORIDE-USP (HEMIHYDRATE) (1)

69 PERPHENAZINE USP (1)

70 PINAVERIUM BROMIDE (1)

71 PIRFENIDONE (1)

72 QUETIAPINE FUMARATE (1)

73 QUETIAPINE FUMARATE USP (1)

74 RABEPRAZOLE SODIUM-USP (HYDRATE, AMORPHOUS) (1)

75 RANOLAZINE (1)

76 REPAGLINIDE USP (1)

77 RISEDRONATE SODIUM HEMIPENTAHYDRATE-USP (1)

78 RISPERIDONE-USP (1)

79 RIVAROXABAN (1)

80 RIVASTIGMINE TARTRATE (1)

81 RIVASTIGMINE USP (1)

82 RIZATRIPTAN BENZOATE USP (1)

83 ROPIVACAINE HYDROCHLORIDE USP (1)

84 ROSUVASTATIN CALCIUM AMORPHOUS (1)

85 SIMVASTATIN USP (1)

86 SITAGLIPTIN PHOSPHATE USP (1)

87 SOLIFENACIN SUCCINATE (1)

88 STANNOUS GLUCONATE COMPLEX (1)

89 STERILE EMPTY VIALS (1)

90 STERILE EVACUATED VIALS (1)

91 TADALAFIL-USP (1)

92 TELMISARTAN (1)

93 TERAZOSIN HYDROCHLORIDE (1)

94 TICAGRELOR (1)

95 TRAMADOL HYDROCHLORIDE USP (1)

96 VALACYCLOVIR HYDROCHLORIDE (1)

97 VALSARTAN USP (1)

98 VARENICLINE TARTRATE (1)

99 VILAZODONE HYDROCHLORIDE (1)

100 VILDAGLIPTIN (1)

101 VORICONAZOLE USP (1)

102 ZIPRASIDONE HYDROCHLORIDE USP (1)

103 ZOLEDRONIC ACID (1)

104 ZOLMITRIPTAN USP (1)

105 ZOPICLONE (1)

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01 DRAXIMAGE INC (1)

02 JUBILANT GENERICS LTD (5)

03 JUBILANT HOLLISTERSTIER LLC (2)

04 JUBILANT LIFE SCIENCES LTD (2)

05 JUBILANT ORGANOSYS LTD (3)

06 JUBILANT PHARMOVA LTD (93)

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01 Canada (1)

02 India (103)

03 U.S.A (2)

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01 Active (99)

02 Inactive (7)

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01 Complete (46)

02 Blank (60)

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JUBILANT LIFE SCIENCE...
Inactive
31794
N/A
2017-06-02
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JUBILANT PHARMOVA LTD
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22333
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2018-11-28
2018-09-26
2009-03-31
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JUBILANT PHARMOVA LTD
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28050
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2014-03-31
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JUBILANT PHARMOVA LTD
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32071
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2017-11-30
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JUBILANT PHARMOVA LTD
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34447
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2020-01-17
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JUBILANT GENERICS LTD
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26852
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2013-03-15
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JUBILANT PHARMOVA LTD
Active
19739
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2014-01-22
2013-12-06
2006-08-31
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JUBILANT PHARMOVA LTD
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21376
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2008-08-01
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JUBILANT PHARMOVA LTD
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29785
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2015-09-29
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JUBILANT PHARMOVA LTD
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30966
Complete
2017-06-28
2017-03-01
2016-12-01
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