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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 EXEMESTANE USP (1)

78 FAMOTIDINE USP (1)

79 FEBUXOSTAT API (1)

80 FESOTERODINE FUMARATE (1)

81 FINGOLIMOD HYDROCHLORIDE USP (1)

82 FLUCONAZOLE USP (1)

83 FLUVASTATIN SODIUM (1)

84 GATIFLOXACIN ANHYDROUS (1)

85 GATIFLOXACIN SESQUIHYDRATE (1)

86 GEMCITABINE HYDROCHLORIDE USP (1)

87 GLYBURIDE (1)

88 HYDROCHLOROTHIAZIDE USP (1)

89 HYDROXYCHLOROQUINE SULFATE USP (1)

90 IMATINIB MESYLATE (1)

91 IMATINIB MESYLATE (AMORPHOUS) (1)

92 IMATINIB MESYLATE (PROCESS II) (1)

93 IRBESARTAN USP (2)

94 IRINOTECAN HYDROCHLORIDE USP (1)

95 IVABRADINE HYDROCHLORIDE (1)

96 LABETALOL HYDROCHLORIDE USP (1)

97 LACOSAMIDE USP (1)

98 LAMOTRIGINE USP (1)

99 LANSOPRAZOLE USP (1)

100 LETERMOVIR (1)

101 LETROZOLE USP (1)

102 LEVOFLOXACIN USP (HEMIHYDRATE) (1)

103 LEVOMILNACIPRAN HYDROCHLORIDE (1)

104 LINAGLIPTIN AMORPHOUS (1)

105 LINEZOLID (1)

106 LORATADINE (1)

107 LORATADINE USP (1)

108 LORATIDINE (1)

109 LORCASERIN HYDROCHLORIDE (1)

110 LOSARTAN POTASSIUM USP (2)

111 LUMATEPERONE TOSYLATE (1)

112 LURASIDONE HYDROCHLORIDE (1)

113 MACITENTAN (1)

114 MELOXICAM USP (1)

115 MEMANTINE HYDROCHLORIDE (1)

116 MEMANTINE HYDROCHLORIDE USP (1)

117 MESALAMINE USP (1)

118 MESALAMINE USP (PROCESS-II) (1)

119 METOPROLOL SUCCINATE USP (1)

120 MIDODRINE HYDROCHLORIDE (1)

121 MIDODRINE HYDROCHLORIDE USP (1)

122 MIRABEGRON (1)

123 NATEGLINIDE USP (1)

124 OLANZAPINE (1)

125 OLANZAPINE USP (1)

126 OLMESARTAN MEDOXOMIL USP (1)

127 OMEPRAZOLE (1)

128 OMEPRAZOLE USP (FORM-B) (1)

129 OSELTAMIVIR PHOSPHATE USP (1)

130 OXALIPLATIN PH EUR (1)

131 PALIPERIDONE (1)

132 PAROXETINE HYDROCHLORIDE USP (HEMIHYDRATE) (1)

133 PAROXETINE HYDROCHLORIDE, ANHYDROUS (1)

134 PERAMPANEL (1)

135 PHENTERMINE HYDROCHLORIDE USP (1)

136 PHTHALOYL AMLODIPINE (1)

137 PIMAVANSERIN TARTRATE (1)

138 PIOGLITAZONE HYDROCHLORIDE USP (1)

139 PITAVASTATIN CALCIUM (1)

140 PITAVASTATIN MAGNESIUM (1)

141 PRAMIPEXOLE DIHYDROCHLORIDE USP (MONOHYDRATE) (1)

142 PREGABALIN (1)

143 PREGABALIN USP (PGC ROUTE) (1)

144 PREGABALIN USP (PROCESS II) (1)

145 PROGUANIL HYDROCHLORIDE USP (1)

146 PROMETHAZINE HYDROCHLORIDE USP (1)

147 PROPAFENONE HYDROCHLORIDE USP (1)

148 Quetiapine Fumarate (1)

149 RABEPRAZOLE SODIUM (1)

150 RANOLAZINE (1)

151 RANOLAZINE (PROCESS II) (1)

152 RIFAXIMIN (PROCESS-I) (1)

153 RIFAXIMIN (PROCESS-II) (1)

154 RISPERIDONE USP (1)

155 RIVASTIGMINE USP (1)

156 ROFLUMILAST USP (1)

157 ROSUVASTATIN CALCIUM USP (1)

158 Rabeprazole Sodium (Amorphous) (1)

159 SALMETEROL XINAFOATE USP (1)

160 SEMAGLUTIDE (1)

161 SERTRALINE HYDROCHLORIDE (1)

162 SILODOSIN (1)

163 SIMVASTATIN (1)

164 SIMVASTATIN ( LOVASTATIN ROUTE) (1)

165 SIMVASTATIN (AMMONIUM SALT ROUTE) (1)

166 SITAGLIPTIN FREE BASE (1)

167 SITAGLIPTIN PHOSPHATE ANHYDROUS (1)

168 SOLIFENACIN SUCCINATE (1)

169 TAMSULOSIN HYDROCHLORIDE USP (1)

170 TELMISARTAN USP (1)

171 TERAZOSIN HYDROCHLORIDE ANHYDROUS (1)

172 TERIFLUNOMIDE (1)

173 TIZANIDINE HYDROCHLORIDE USP (1)

174 TOFACITINIB CITRATE (1)

175 TOPIRAMATE USP (1)

176 TRAMADOL HYDROCHLORIDE (1)

177 TRAMADOL HYDROCHLORIDE USP (1)

178 TRAZODONE HYDROCHLORIDE USP (1)

179 VALACYCLOVIR HYDROCHLORIDE USP (1)

180 VALSARTAN USP (2)

181 VENLAFAXINE HYDROCHLORIDE PH EUR (1)

182 VENLAFAXINE HYDROCHLORIDE USP (1)

183 VILAZODONE HYDROCHLORIDE (1)

184 VILOXAZINE HYDROCHLORIDE (1)

185 VORTIOXETINE HYDROBROMIDE (1)

186 VOXELOTOR (1)

187 WARFARIN SODIUM USP (CRYSTALLINE CLATHRATE) (1)

188 ZALEPLON (1)

189 ZIPRASIDONE HYDROCHLORIDE ANHYDROUS (1)

190 ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USP (1)

191 ZOLPIDEM TARTRATE (1)

192 ZONISAMIDE (1)

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01 CADILA HEALTHCARE LTD (60)

02 CADILA HEALTHCARE LTD ZYFINE (1)

03 ZYDUS LIFESCIENCES LTD (133)

04 ZYDUS WORLDWIDE DMCC (1)

05 ZYFINE DIV CADILA HEALTHCARE LTD (1)

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01 India (196)

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01 Active (137)

02 Inactive (59)

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01 Complete (87)

02 Blank (109)

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