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

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01 ADEFOVIR DIPIVOXIL (1)

02 ALFUZOSIN HYDROCHLORIDE USP (1)

03 ALMOTRIPTAN MALATE (1)

04 ALPRAZOLAM USP (1)

05 ANASTROZOLE USP (1)

06 APIXABAN (1)

07 ARIPIPRAZOLE USP (1)

08 ATOMOXETINE HYDROCHLORIDE USP (1)

09 ATORVASTATIN CALCIUM GRANULATION (1)

10 BICALUTAMIDE USP (1)

11 BUDESONIDE USP (1)

12 BUSPIRONE HYDROCHLORIDE (1)

13 CABERGOLINE USP (2)

14 CANDESARTAN CILEXETIL USP (1)

15 CAPECITABINE USP (1)

16 CARVEDILOL DIHYDROGEN PHOSPHATE (1)

17 CEVIMELINE HYDROCHLORIDE HEMIHYDRATE (1)

18 CIMETIDINE (1)

19 CLONAZEPAM USP (1)

20 CYCLOSPORINE USP (BULK) (1)

21 CYTARABINE USP XXI (1)

22 DABIGATRAN ETEXILATE MESYLATE (1)

23 DARIFENACIN HYDROBROMIDE (1)

24 DEFERASIROX (1)

25 DEFERIPRONE (1)

26 DESVENLAFAXINE SUCCINATE MONOHYDRATE (1)

27 DEXLANSOPRAZOLE ANHYDRATE (1)

28 DOLASETRON MESYLATE MONOHYDRATE USP (1)

29 DONEPEZIL HYDROCHLORIDE MONOHYDRRATE USP (1)

30 DOXAZOSIN MESYLATE USP (1)

31 DRONEDARONE HYDROCHLORIDE (1)

32 ELETRIPTAN HYDROBROMIDE (1)

33 ELIGLUSTAT TARTRATE (1:0.5) (1)

34 ENALAPRIL MALEATE USP (1)

35 ENTECAVIR USP (1)

36 EPLERENONE MEK HEMISOLVATE (1:0.5) (1)

37 ERLOTINIB HYDROCHLORIDE (1)

38 ESZOPICLONE USP (1)

39 ETRAVIRINE (1)

40 EXEMESTANE (1)

41 FAMOTIDINE USP (1)

42 FEBUXOSTAT (1)

43 FESOTERODINE FUMARATE (1)

44 FINGOLIMOD HYDROCHLORIDE (1)

45 FLUTICASONE PROPIONATE USP (MICRONIZED) (1)

46 FLUVOXAMINE MALEATE USP (1)

47 GAMMA-HYDROXYBUTYRATE (1)

48 GATIFLOXACIN HEMIHYDRATE (1)

49 IBANDRONATE SODIUM (1)

50 LAMOTRIGINE (1)

51 LANSOPRAZOLE USP (1)

52 LETROZOLE USP (1)

53 LEVOFLOXACIN USP (1)

54 LEVOTHYROXINE SODIUM USP (2)

55 LINEZOLID (1)

56 LUBIPROSTONE (2)

57 LURASIDONE HYDROCHLORIDE (1)

58 MEMANTINE HYDROCHLORIDE USP (1)

59 METHACHOLINE CHLORIDE USP (1)

60 MIDODRINE HYDROCHLORIDE USP (1)

61 MISOPROSTOL 4% DISPERSION ON HYDROXYPROPYL METHYLCELLULOSE (HPMC) (1)

62 MOEXIPRIL HYDROCHLORIDE USP (1)

63 MONTELUKAST SODIUM USP (1)

64 MYCOPHENOLATE MOFETIL USP (2)

65 MYCOPHENOLATE SODIUM USP (1)

66 NARATRIPTAN HYDROCHLORIDE USP (1)

67 OLANZAPINE FORM II USP (1)

68 OLANZAPINE USP (2)

69 OLMESARTAN MEDOXOMIL USP (1)

70 OLOPATADINE HYDROCHLORIDE USP (1)

71 PALBOCICLIB (1)

72 PALIPERIDONE USP (1)

73 PAMIDRONIC ACID (1)

74 PAROXETINE HYDROCHLORIDE (ANHYDROUS) (1)

75 PAROXETINE HYDROCHLORIDE ANHYDROUS USP (1)

76 PERINDOPRIL ARGININE (1)

77 PERINDOPRIL TERT-BUTYLAMINE (1)

78 POSACONAZOLE (1)

79 PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP (1)

80 PRASUGREL HYDROCHLORIDE (1)

81 PRAVASTATIN SODIUM (1)

82 RALOXIFENE HYDROCHLORIDE USP (1)

83 RAMIPRIL USP (1)

84 RANITIDINE HCL USP (1)

85 RANOLAZINE (1)

86 RASAGILINE MESYLATE (1)

87 RILUZOLE USP (1)

88 RISEDRONATE SODIUM HEMIPENTAHYDRATE USP (1)

89 RISPERIDONE USP (1)

90 RIVAROXABAN (1)

91 RIVASTIGMINE TARTRATE (1)

92 RIVASTIGMINE USP (1)

93 RIZATRIPTAN BENZOATE USP (1)

94 ROSUVASTATIN CALCIUM (1)

95 RUFINAMIDE USP (1)

96 SAXAGLIPTIN HCI WITH MANNITOL COPRECIPITATE 20% (1)

97 SELEXIPAG (1)

98 SITAGLIPTIN PHOSPHATE MONOHYDRATE USP (1)

99 SUMATRIPTAN SUCCINATE USP (1)

100 TADALAFIL USP (1)

101 TASIMELTEON (1)

102 TERAZOSIN HCI DIHYDRATE (1)

103 TETRABENAZINE (1)

104 TIZANIDINE HYDROCHLORIDE USP (1)

105 TOFACITINIB CITRATE (1)

106 TOLTERODINE TARTRATE (1)

107 TOLVAPTAN (1)

108 TORSEMIDE USP (1)

109 TREPROSTINIL DIETHANOLAMINE (1)

110 TROSPIUM CHLORIDE USP (1)

111 VALACYCLOVIR HYDROCHLORIDE MONOHYDRATE USP (1)

112 VALGANCICLOVIR HYDROCHLORIDE USP (1)

113 VARENICLINE TARTRATE (1)

114 VENLAFAXINE HYDROCHLORIDE USP (1)

115 VILAZODONE HYDROCHLORIDE BENZYL ALCOHOL MONOSOLVATE (1)

116 VORICONAZOLE USP (1)

117 WARFARIN POTASSIUM ISOPROPANOL SOLVATE (1)

118 WARFARIN SODIUM CLATHRATE USP (1)

119 ZALEPLON (1)

120 ZIPRASIDONE HYDROCHLORIDE (1)

121 ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USP (1)

122 ZOLMITRIPTAN (1)

123 ZONISAMIDE (1)

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01 APOTEX PHARMACHEM INC (60)

02 APOTEX PHARMACHEM INDIA PVT LTD (62)

03 SIGNA SA DE CV (5)

04 SIGNS SA DE CV (1)

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01 Canada (121)

02 India (7)

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01 Active (62)

02 Inactive (66)

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01 Complete (32)

02 Blank (96)

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APOTEX PHARMACHEM INC
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Complete
2013-08-26
2012-12-06
2012-12-07
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APOTEX PHARMACHEM INC
Active
20595
N/A
2007-06-08
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APOTEX PHARMACHEM IND...
Inactive
25225
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2011-08-16
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APOTEX PHARMACHEM IND...
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25074
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2011-06-24
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APOTEX PHARMACHEM INC
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23326
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2009-12-01
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APOTEX PHARMACHEM IND...
Inactive
30499
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2016-06-20
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APOTEX PHARMACHEM INC
Active
19957
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2006-11-13
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APOTEX PHARMACHEM INC
Active
20070
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2007-05-18
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APOTEX PHARMACHEM INC
Inactive
20117
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2006-12-15
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SIGNA SA DE CV
Inactive
22784
N/A
2009-05-15
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