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

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01 ABACAVIR SULFATE USP (1)

02 ACYCLOVIR USP (1)

03 ADEFOVIR DIPIVOXIL (1)

04 ALENDRONATE SODIUM TRIHYDRATE USP (2)

05 ALFUZOSIN HYDROCHLORIDE USP (1)

06 ALLOPURINOL USP (1)

07 ALMOTRIPTAN MALATE (1)

08 ALPHA METHYL DOPA USP (1)

09 ALPRAZOLAM USP (1)

10 ANASTROZOLE USP (1)

11 APIXABAN (1)

12 ARIPIPRAZOLE USP (1)

13 ASENAPINE MALEATE (1)

14 ATAZANAVIR SULFATE (1)

15 ATOMOXETINE HYDROCHLORIDE USP (1)

16 ATORVASTATIN CALCIUM GRANULATION (1)

17 ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE USP (1)

18 AZT (ZIDOVUDINE) (1)

19 BALSALAZIDE DISODIUM DIHYDRATE USP (1)

20 BICALUTAMIDE USP (1)

21 BREXPIPRAZOLE (1)

22 BUDESONIDE USP (1)

23 BULK EVEROLIMUS (1)

24 BUSPIRONE HYDROCHLORIDE (1)

25 CABERGOLINE USP (2)

26 CANDESARTAN CILEXETIL USP (1)

27 CAPECITABINE USP (2)

28 CARVEDILOL DIHYDROGEN PHOSPHATE (1)

29 CEVIMELINE HYDROCHLORIDE HEMIHYDRATE (1)

30 CIMETIDINE (1)

31 CLONAZEPAM USP (1)

32 CLOPIDOGREL BISULPHATE USP (1)

33 CRUDE METRONIDAZOLE (1)

34 CYCLOSPORINE USP (BULK) (1)

35 CYTARABINE USP XXI (1)

36 DABIGATRAN ETEXILATE MESYLATE (1)

37 DARIFENACIN HYDROBROMIDE (1)

38 DEFERASIROX (1)

39 DEFERIPRONE (1)

40 DESVENLAFAXINE SUCCINATE MONOHYDRATE (1)

41 DEXLANSOPRAZOLE ANHYDRATE (1)

42 DIDEOXYINOSINE (1)

43 DOLASETRON MESYLATE MONOHYDRATE USP (1)

44 DONEPEZIL HYDROCHLORIDE MONOHYDRRATE USP (1)

45 DOXAZOSIN MESYLATE USP (1)

46 DRONEDARONE HYDROCHLORIDE (1)

47 DULOXETINE HYDROCHLORIDE USP (1)

48 ELETRIPTAN HYDROBROMIDE (1)

49 ELIGLUSTAT TARTRATE (1:0.5) (1)

50 ENALAPRIL MALEATE USP (1)

51 ENTECAVIR USP (1)

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

53 ERLOTINIB HYDROCHLORIDE (1)

54 ESZOPICLONE USP (1)

55 ETRAVIRINE (1)

56 EXEMESTANE (1)

57 EZETIMIBE USP (1)

58 FACILITIES, PERSONNEL AND CONTROLS IN WESTON, ONTARIO (1)

59 FAMCICLOVIR USP (1)

60 FAMOTIDINE USP (1)

61 FEBUXOSTAT (1)

62 FESOTERODINE FUMARATE (1)

63 FINGOLIMOD HYDROCHLORIDE (1)

64 FLUCONAZOLE (1)

65 FLUTICASONE PROPIONATE USP (MICRONIZED) (1)

66 FLUVOXAMINE MALEATE USP (1)

67 GAMMA-HYDROXYBUTYRATE (1)

68 GATIFLOXACIN HEMIHYDRATE (2)

69 GEIBROZIL USP (1)

70 GEIBROZIL USP (GEA PROCESS) (1)

71 IBANDRONATE SODIUM (1)

72 IMATINIB MESYLATE (1)

73 IRBESARTAN USP (1)

74 LACOSAMIDE (1)

75 LAMIVUDINE METHANOL SOLVATE USP (1)

76 LAMOTRIGINE (1)

77 LANSOPRAZOLE USP (1)

78 LANTHANUM CARBONATE HYDRATE (1)

79 LETROZOLE USP (1)

80 LEVETIRACETAM USP (1)

81 LEVOFLOXACIN USP (1)

82 LEVOTHYROXINE SODIUM USP (2)

83 LINEZOLID (1)

84 LUBIPROSTONE (2)

85 LURASIDONE HYDROCHLORIDE (1)

86 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ONTARIO, CANADA. (1)

87 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. (1)

88 MEMANTINE HYDROCHLORIDE USP (1)

89 MESALAMINE USP (1)

90 METHACHOLINE CHLORIDE USP (1)

91 MIDODRINE HYDROCHLORIDE USP (1)

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

93 MOEXIPRIL HYDROCHLORIDE USP (1)

94 MONTELUKAST SODIUM USP (1)

95 MYCOPHENOLATE MOFETIL USP (2)

96 MYCOPHENOLATE SODIUM USP (1)

97 NADOLOL USP (1)

98 NARATRIPTAN HYDROCHLORIDE USP (1)

99 NEFAZODONE HYDROCHLORIDE (1)

100 OLANZAPINE FORM II USP (1)

101 OLANZAPINE USP (2)

102 OLMESARTAN MEDOXOMIL USP (1)

103 OLOPATADINE HYDROCHLORIDE USP (1)

104 OXCARBAZEPINE USP (1)

105 PALBOCICLIB (1)

106 PALIPERIDONE USP (1)

107 PAMIDRONIC ACID (1)

108 PAROXETINE HYDROCHLORIDE (ANHYDROUS) (1)

109 PAROXETINE HYDROCHLORIDE ANHYDROUS USP (1)

110 PAROXETINE HYDROCHLORIDE HEMIHYDRATE USP (1)

111 PAZOPANIB HYDROCHLORIDE (1)

112 PERINDOPRIL ARGININE (1)

113 PERINDOPRIL TERT-BUTYLAMINE (1)

114 PIOGLITAZONE HYDROCHLORIDE USP (1)

115 PIRFENIDONE EP (1)

116 PONATINIB HYDROCHLORIDE (1)

117 POSACONAZOLE (1)

118 PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP (1)

119 PRASUGREL HYDROCHLORIDE (1)

120 PRAVASTATIN SODIUM (1)

121 PROGESTERONE USP (1)

122 QUINAPRIL HYDROCHLORIDE ACETONE SOLVATE (1)

123 RALOXIFENE HYDROCHLORIDE USP (1)

124 RAMIPRIL USP (1)

125 RANITIDINE HCL USP (1)

126 RANOLAZINE (1)

127 RASAGILINE MESYLATE (1)

128 RILUZOLE USP (1)

129 RISEDRONATE SODIUM HEMIPENTAHYDRATE USP (1)

130 RISPERIDONE USP (1)

131 RIVAROXABAN (1)

132 RIVASTIGMINE TARTRATE (1)

133 RIVASTIGMINE USP (1)

134 RIZATRIPTAN BENZOATE USP (1)

135 ROSUVASTATIN CALCIUM (1)

136 RUFINAMIDE USP (1)

137 SAXAGLIPTIN HCI WITH MANNITOL COPRECIPITATE 20% (1)

138 SELEXIPAG (1)

139 SILDENAFIL CITRATE USP (1)

140 SIROLIMUS DRUG SUBSTANCE (1)

141 SITAGLIPTIN PHOSPHATE MONOHYDRATE USP (2)

142 SODIUM VALPROATE (1)

143 SUMATRIPTAN SUCCINATE USP (1)

144 TACROLIMUS USP (1)

145 TADALAFIL USP (1)

146 TASIMELTEON (1)

147 TELMISARTAN USP/EP (1)

148 TERAZOSIN HCI DIHYDRATE (1)

149 TERAZOSIN HYDROCHLORIDE DIHYDRATE USP (1)

150 TETRABENAZINE (1)

151 TIAGABINE HYDROCHLORIDE MONOHYDRATE USP (1)

152 TIZANIDINE HYDROCHLORIDE USP (1)

153 TOFACITINIB CITRATE (1)

154 TOLTERODINE TARTRATE (1)

155 TOLVAPTAN (1)

156 TOPIRAMATE USP (1)

157 TORSEMIDE USP (1)

158 TREPROSTINIL DIETHANOLAMINE (1)

159 TROSPIUM CHLORIDE USP (1)

160 VALACYCLOVIR HYDROCHLORIDE MONOHYDRATE USP (1)

161 VALGANCICLOVIR HYDROCHLORIDE USP (1)

162 VALPROIC ACID USP (1)

163 VALSARTAN USP (1)

164 VARENICLINE TARTRATE (1)

165 VENLAFAXINE HYDROCHLORIDE USP (1)

166 VILAZODONE HYDROCHLORIDE BENZYL ALCOHOL MONOSOLVATE (1)

167 VORICONAZOLE USP (1)

168 WARFARIN POTASSIUM ISOPROPANOL SOLVATE (1)

169 WARFARIN SODIUM CLATHRATE USP (1)

170 ZALEPLON (1)

171 ZIPRASIDONE HYDROCHLORIDE (1)

172 ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USP (1)

173 ZOLMITRIPTAN (1)

174 ZONISAMIDE (1)

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01 APOTEX INC (2)

02 APOTEX PHARMACHEM INC (64)

03 APOTEX PHARMACHEM INDIA PVT LTD (62)

04 SIGNA SA (2)

05 SIGNA SA DE CV (49)

06 SIGNS SA DE CV (1)

07 TORPHARM INC (1)

08 ZHEJIANG LEPU PHARMACEUTICAL CO LTD (2)

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01 Canada (128)

02 India (7)

03 Mexico (48)

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01 Active (85)

02 Inactive (98)

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01 Complete (50)

02 Blank (133)

URL Supplier Web Content
SIGNA SA DE CV
Active
23644
Complete
2014-07-15
2014-07-07
2010-03-19
II
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SIGNA SA DE CV
Active
22949
Complete
2014-01-03
2013-12-11
2009-07-16
II
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APOTEX PHARMACHEM INC
Active
26630
Complete
2013-08-26
2012-12-06
2012-12-07
II
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APOTEX PHARMACHEM INC
Active
15409
N/A
2001-04-30
II
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SIGNA SA DE CV
Inactive
16129
N/A
2002-09-10
II
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APOTEX PHARMACHEM INC
Active
20595
N/A
2007-06-08
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SIGNA SA DE CV
Active
15841
N/A
2002-02-04
II
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APOTEX PHARMACHEM IND...
Inactive
25225
N/A
2011-08-16
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SIGNA SA
Inactive
6363
N/A
1986-05-16
II
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APOTEX PHARMACHEM IND...
Inactive
25074
N/A
2011-06-24
II
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