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

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01 ALBENDAZOLE USP (1)

02 ALFUZOSIN HYDROCHLORIDE (1)

03 AMLODIPINE BESILATE USP (1)

04 AMLODIPINE BESYLATE USP (1)

05 ANAGRELIDE HYDROCHLORIDE USP (1)

06 ANASTROZOLE (1)

07 APALUTAMIDE (1)

08 APIXABAN (1)

09 APREMILAST (1)

10 ARIPIPRAZOLE USP (1)

11 ARSENIC TRIOXIDE (1)

12 ASPIRIN USP (1)

13 ATENOLOL USP (1)

14 ATOMOXETINE HCL USP (1)

15 ATORVASTATIN CALCIUM (CRYSTALLINE FORM I) (1)

16 ATORVASTATIN CALCIUM (CRYSTALLINE) (1)

17 ATORVASTATIN CALCIUM USP (1)

18 ATORVASTATIN PROTECTED DIOL (1)

19 ATOVAQUONE USP (1)

20 AZATHIOPRINE USP (1)

21 AZELASTINE HYDROCHLORIDE (1)

22 BENAZEPRIL HYDROCHLORIDE USP (1)

23 BENZOYL PEROXIDE HYDROUS USP (1)

24 BOSENTAN MONOHYDRATE (1)

25 BREXPIPRAZOLE (1)

26 BRIVARACETAM (1)

27 BUPROPION HYDROCHLORIDE (1)

28 BUPROPION HYDROCHLORIDE USP (PROCESS-II) (1)

29 BUSPIRONE HYDROCHLORIDE USP (1)

30 CALCIUM GLUCONATE MONOHYDRATE USP (1)

31 CANAGLIFLOZIN (1)

32 CANDESARTAN CILEXETIL USP (2)

33 CAPECITABINE USP (1)

34 CARVEDILOL (FORM II) (1)

35 CARVEDILOL USP (1)

36 CHLORTHALIDONE USP (1)

37 CINACALCET HYDROCHLORIDE (1)

38 CLINDAMYCIN HYDROCHLORIDE (1)

39 CLINDAMYCIN PHOSPHATE USP (1)

40 CLONIDINE (1)

41 CLOPIDOGREL BISULFATE USP (1)

42 CLOPIDOGREL BISULFATE USP (FORM-I) (1)

43 CLOPIDOGREL BISULFATE USP (FORM-I) (CUE ROUTE) (1)

44 CLOPIDOGREL BISULFATE USP (PROCESS-II) (1)

45 CLOPIDOGREL BISULFATE USP (PROCESS-III) (1)

46 COLESTIPOL HYDROCHLORIDE USP (1)

47 CSA SALT OF CLOPIDOGREL (1)

48 DABIGATRAN ETEXILATE MESYLATE (1)

49 DAPAGLIFLOZIN (1)

50 DARUNAVIR (1)

51 DEFERIPRONE (1)

52 DESVENLAFAXINE BASE (1)

53 DESVENLAFAXINE SUCCINATE USP (1)

54 DICLOFENAC EPOLAMINE (1)

55 DIMETHYL FUMARATE (1)

56 DIROXIMEL FUMARATE (1)

57 DONEPEZIL HYDROCHLORIDE USP (1)

58 DULOXETINE HYDROCHLORIDE USP (1)

59 DULOXETINE HYDROCHLORIDE USP (DUB ROUTE) (1)

60 DULOXETINE HYDROCHLORIDE USP (PROCESS-II) (1)

61 EDOXABAN TOSYLATE MONOHYDRATE (1)

62 ELTROMBOPAG OLAMINE (1)

63 EMPAGLIFLOZIN (1)

64 ENTECAVIR USP (1)

65 ENZALUTAMIDE (1)

66 ENZALUTAMIDE (PROCESS II) (1)

67 ERLOTINIB HYDROCHLORIDE (FORM-A) (1)

68 ERLOTINIB HYDROCHLORIDE (FORM-B) (1)

69 ESCITALOPRAM OXALATE (FORM -1) (1)

70 ESCITALOPRAM OXALATE USP (1)

71 ESOMEPRAZOLE MAGNESIUM DIHYDRATE (1)

72 ESOMEPRAZOLE MAGNESIUM DIHYDRATE (PROCESS II) (1)

73 ESOMEPRAZOLE SODIUM (1)

74 ETHACRYNIC ACID USP (1)

75 ETODOLAC USP (1)

76 EXEMESTANE (1)

77 FAMOTIDINE USP (1)

78 FEBUXOSTAT API (1)

79 FESOTERODINE FUMARATE (1)

80 FINGOLIMOD HYDROCHLORIDE USP (1)

81 FLUCONAZOLE USP (1)

82 FLUVASTATIN SODIUM (1)

83 GATIFLOXACIN ANHYDROUS (1)

84 GATIFLOXACIN SESQUIHYDRATE (1)

85 GEMCITABINE HYDROCHLORIDE USP (1)

86 GLYBURIDE (1)

87 HYDROCHLOROTHIAZIDE USP (1)

88 HYDROXYCHLOROQUINE SULFATE USP (1)

89 IMATINIB MESYLATE (1)

90 IMATINIB MESYLATE (AMORPHOUS) (1)

91 IMATINIB MESYLATE (PROCESS II) (1)

92 IRBESARTAN USP (2)

93 IRINOTECAN HYDROCHLORIDE USP (1)

94 IVABRADINE HYDROCHLORIDE (1)

95 LABETALOL HYDROCHLORIDE USP (1)

96 LACOSAMIDE USP (1)

97 LAMOTRIGINE USP (1)

98 LANSOPRAZOLE USP (1)

99 LETERMOVIR (1)

100 LETROZOLE USP (1)

101 LEVOFLOXACIN USP (HEMIHYDRATE) (1)

102 LEVOMILNACIPRAN HYDROCHLORIDE (1)

103 LINAGLIPTIN AMORPHOUS (1)

104 LINEZOLID (1)

105 LORATADINE (1)

106 LORATADINE USP (1)

107 LORATIDINE (1)

108 LORCASERIN HYDROCHLORIDE (1)

109 LOSARTAN POTASSIUM USP (2)

110 LUMATEPERONE TOSYLATE (1)

111 LURASIDONE HYDROCHLORIDE (1)

112 MACITENTAN (1)

113 MELOXICAM USP (1)

114 MEMANTINE HYDROCHLORIDE (1)

115 MEMANTINE HYDROCHLORIDE USP (1)

116 MESALAMINE USP (1)

117 MESALAMINE USP (PROCESS-II) (1)

118 METOPROLOL SUCCINATE USP (1)

119 MIDODRINE HYDROCHLORIDE (1)

120 MIDODRINE HYDROCHLORIDE USP (1)

121 MIRABEGRON (1)

122 NATEGLINIDE USP (1)

123 OLANZAPINE (1)

124 OLANZAPINE USP (1)

125 OLMESARTAN MEDOXOMIL USP (1)

126 OMEPRAZOLE (1)

127 OMEPRAZOLE USP (FORM-B) (1)

128 OSELTAMIVIR PHOSPHATE USP (1)

129 OXALIPLATIN PH EUR (1)

130 PALIPERIDONE (1)

131 PAROXETINE HYDROCHLORIDE USP (HEMIHYDRATE) (1)

132 PAROXETINE HYDROCHLORIDE, ANHYDROUS (1)

133 PERAMPANEL (1)

134 PHENTERMINE HYDROCHLORIDE USP (1)

135 PHTHALOYL AMLODIPINE (1)

136 PIMAVANSERIN TARTRATE (1)

137 PIOGLITAZONE HYDROCHLORIDE USP (1)

138 PITAVASTATIN CALCIUM (1)

139 PITAVASTATIN MAGNESIUM (1)

140 PRAMIPEXOLE DIHYDROCHLORIDE USP (MONOHYDRATE) (1)

141 PREGABALIN (1)

142 PREGABALIN USP (PGC ROUTE) (1)

143 PREGABALIN USP (PROCESS II) (1)

144 PROGUANIL HYDROCHLORIDE USP (1)

145 PROMETHAZINE HYDROCHLORIDE USP (1)

146 PROPAFENONE HYDROCHLORIDE USP (1)

147 Quetiapine Fumarate (1)

148 RABEPRAZOLE SODIUM (1)

149 RANOLAZINE (1)

150 RANOLAZINE (PROCESS II) (1)

151 RIFAXIMIN (PROCESS-I) (1)

152 RIFAXIMIN (PROCESS-II) (1)

153 RISPERIDONE USP (1)

154 RIVASTIGMINE USP (1)

155 ROFLUMILAST (1)

156 ROSUVASTATIN CALCIUM USP (1)

157 Rabeprazole Sodium (Amorphous) (1)

158 SALMETEROL XINAFOATE USP (1)

159 SEMAGLUTIDE (1)

160 SERTRALINE HYDROCHLORIDE (1)

161 SILODOSIN (1)

162 SIMVASTATIN (1)

163 SIMVASTATIN ( LOVASTATIN ROUTE) (1)

164 SIMVASTATIN (AMMONIUM SALT ROUTE) (1)

165 SITAGLIPTIN FREE BASE (1)

166 SITAGLIPTIN PHOSPHATE ANHYDROUS (1)

167 SOLIFENACIN SUCCINATE (1)

168 TAMSULOSIN HYDROCHLORIDE USP (1)

169 TELMISARTAN USP (1)

170 TERAZOSIN HYDROCHLORIDE ANHYDROUS (1)

171 TERIFLUNOMIDE (1)

172 TIZANIDINE HYDROCHLORIDE USP (1)

173 TOFACITINIB CITRATE (1)

174 TOPIRAMATE USP (1)

175 TRAMADOL HYDROCHLORIDE (1)

176 TRAMADOL HYDROCHLORIDE USP (1)

177 TRAZODONE HYDROCHLORIDE USP (1)

178 VALACYCLOVIR HYDROCHLORIDE USP (1)

179 VALSARTAN USP (2)

180 VENLAFAXINE HYDROCHLORIDE PH EUR (1)

181 VENLAFAXINE HYDROCHLORIDE USP (1)

182 VILAZODONE HYDROCHLORIDE (1)

183 VILOXAZINE HYDROCHLORIDE (1)

184 VORTIOXETINE HYDROBROMIDE (1)

185 VOXELOTOR (1)

186 WARFARIN SODIUM USP (CRYSTALLINE CLATHRATE) (1)

187 ZALEPLON (1)

188 ZIPRASIDONE HYDROCHLORIDE ANHYDROUS (1)

189 ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USP (1)

190 ZOLPIDEM TARTRATE (1)

191 ZONISAMIDE (1)

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01 CADILA HEALTHCARE LTD (60)

02 CADILA HEALTHCARE LTD ZYFINE (1)

03 ZYDUS LIFESCIENCES LTD (132)

04 ZYDUS WORLDWIDE DMCC (1)

05 ZYFINE DIV CADILA HEALTHCARE LTD (1)

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01 India (195)

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01 Active (136)

02 Inactive (59)

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01 Complete (87)

02 Blank (108)

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ZYDUS LIFESCIENCES LT...
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35372
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2020-11-28
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CADILA HEALTHCARE LTD
Inactive
20379
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2007-03-28
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ZYDUS LIFESCIENCES LT...
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18827
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2005-09-30
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ZYDUS LIFESCIENCES LT...
Active
22930
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2014-04-18
2014-04-04
2009-07-08
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ZYDUS LIFESCIENCES LT...
Active
16531
Complete
2014-11-14
2014-06-11
2003-03-30
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