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LGM Pharma API Sourcing. CDMO Services, Regulatory Expertise. LGM Pharma API Sourcing. CDMO Services, Regulatory Expertise.

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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 CANAGLIFLOZIN (1)

31 CANDESARTAN CILEXETIL USP (2)

32 CAPECITABINE USP (1)

33 CARVEDILOL (FORM II) (1)

34 CARVEDILOL USP (1)

35 CHLORTHALIDONE USP (1)

36 CINACALCET HYDROCHLORIDE (1)

37 CLINDAMYCIN HYDROCHLORIDE (1)

38 CLINDAMYCIN PHOSPHATE USP (1)

39 CLONIDINE (1)

40 CLOPIDOGREL BISULFATE USP (1)

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

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

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

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

45 COLESTIPOL HYDROCHLORIDE USP (1)

46 CSA SALT OF CLOPIDOGREL (1)

47 DABIGATRAN ETEXILATE MESYLATE (1)

48 DAPAGLIFLOZIN (1)

49 DARUNAVIR (1)

50 DEFERIPRONE (1)

51 DESVENLAFAXINE BASE (1)

52 DESVENLAFAXINE SUCCINATE USP (1)

53 DICLOFENAC EPOLAMINE (1)

54 DIMETHYL FUMARATE (1)

55 DIROXIMEL FUMARATE (1)

56 DONEPEZIL HYDROCHLORIDE USP (1)

57 DULOXETINE HYDROCHLORIDE USP (1)

58 DULOXETINE HYDROCHLORIDE USP (DUB ROUTE) (1)

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

60 EDOXABAN TOSYLATE MONOHYDRATE (1)

61 ELTROMBOPAG OLAMINE (1)

62 EMPAGLIFLOZIN (1)

63 ENTECAVIR USP (1)

64 ENZALUTAMIDE (1)

65 ENZALUTAMIDE (PROCESS II) (1)

66 ERLOTINIB HYDROCHLORIDE (FORM-A) (1)

67 ERLOTINIB HYDROCHLORIDE (FORM-B) (1)

68 ESCITALOPRAM OXALATE (FORM -1) (1)

69 ESCITALOPRAM OXALATE USP (1)

70 ESOMEPRAZOLE MAGNESIUM DIHYDRATE (1)

71 ESOMEPRAZOLE MAGNESIUM DIHYDRATE (PROCESS II) (1)

72 ESOMEPRAZOLE SODIUM (1)

73 ETHACRYNIC ACID USP (1)

74 ETODOLAC USP (1)

75 EXEMESTANE (1)

76 FAMOTIDINE USP (1)

77 FEBUXOSTAT API (1)

78 FESOTERODINE FUMARATE (1)

79 FINGOLIMOD HYDROCHLORIDE USP (1)

80 FLUCONAZOLE USP (1)

81 FLUVASTATIN SODIUM (1)

82 GATIFLOXACIN ANHYDROUS (1)

83 GATIFLOXACIN SESQUIHYDRATE (1)

84 GEMCITABINE HYDROCHLORIDE USP (1)

85 GLYBURIDE (1)

86 HYDROCHLOROTHIAZIDE USP (1)

87 HYDROXYCHLOROQUINE SULFATE USP (1)

88 IMATINIB MESYLATE (1)

89 IMATINIB MESYLATE (AMORPHOUS) (1)

90 IMATINIB MESYLATE (PROCESS II) (1)

91 IRBESARTAN USP (2)

92 IRINOTECAN HYDROCHLORIDE USP (1)

93 IVABRADINE HYDROCHLORIDE (1)

94 LACOSAMIDE USP (1)

95 LAMOTRIGINE USP (1)

96 LANSOPRAZOLE USP (1)

97 LETERMOVIR (1)

98 LETROZOLE USP (1)

99 LEVOFLOXACIN USP (HEMIHYDRATE) (1)

100 LEVOMILNACIPRAN HYDROCHLORIDE (1)

101 LINAGLIPTIN AMORPHOUS (1)

102 LINEZOLID (1)

103 LORATADINE (1)

104 LORATADINE USP (1)

105 LORATIDINE (1)

106 LORCASERIN HYDROCHLORIDE (1)

107 LOSARTAN POTASSIUM USP (2)

108 LURASIDONE HYDROCHLORIDE (1)

109 MACITENTAN (1)

110 MELOXICAM USP (1)

111 MEMANTINE HYDROCHLORIDE (1)

112 MEMANTINE HYDROCHLORIDE USP (1)

113 MESALAMINE USP (1)

114 MESALAMINE USP (PROCESS-II) (1)

115 METOPROLOL SUCCINATE USP (1)

116 MIDODRINE HYDROCHLORIDE (1)

117 MIDODRINE HYDROCHLORIDE USP (1)

118 MIRABEGRON (1)

119 NATEGLINIDE USP (1)

120 OLANZAPINE (1)

121 OLANZAPINE USP (1)

122 OLMESARTAN MEDOXOMIL USP (1)

123 OMEPRAZOLE (1)

124 OMEPRAZOLE USP (FORM-B) (1)

125 OSELTAMIVIR PHOSPHATE USP (1)

126 OXALIPLATIN PH EUR (1)

127 PALIPERIDONE (1)

128 PAROXETINE HYDROCHLORIDE USP (HEMIHYDRATE) (1)

129 PAROXETINE HYDROCHLORIDE, ANHYDROUS (1)

130 PERAMPANEL (1)

131 PHENTERMINE HYDROCHLORIDE USP (1)

132 PHTHALOYL AMLODIPINE (1)

133 PIMAVANSERIN TARTRATE (1)

134 PIOGLITAZONE HYDROCHLORIDE USP (1)

135 PITAVASTATIN CALCIUM (1)

136 PITAVASTATIN MAGNESIUM (1)

137 PRAMIPEXOLE DIHYDROCHLORIDE USP (MONOHYDRATE) (1)

138 PREGABALIN (1)

139 PREGABALIN USP (PGC ROUTE) (1)

140 PREGABALIN USP (PROCESS II) (1)

141 PROGUANIL HYDROCHLORIDE USP (1)

142 PROMETHAZINE HYDROCHLORIDE (1)

143 PROPAFENONE HYDROCHLORIDE USP (1)

144 Quetiapine Fumarate (1)

145 RABEPRAZOLE SODIUM (1)

146 RANOLAZINE (1)

147 RANOLAZINE (PROCESS II) (1)

148 RIFAXIMIN (PROCESS-I) (1)

149 RIFAXIMIN (PROCESS-II) (1)

150 RISPERIDONE USP (1)

151 RIVASTIGMINE USP (1)

152 ROFLUMILAST (1)

153 ROSUVASTATIN CALCIUM USP (1)

154 Rabeprazole Sodium (Amorphous) (1)

155 SALMETEROL XINAFOATE USP (1)

156 SEMAGLUTIDE (1)

157 SERTRALINE HYDROCHLORIDE (1)

158 SILODOSIN (1)

159 SIMVASTATIN (1)

160 SIMVASTATIN ( LOVASTATIN ROUTE) (1)

161 SIMVASTATIN (AMMONIUM SALT ROUTE) (1)

162 SITAGLIPTIN FREE BASE (1)

163 SITAGLIPTIN PHOSPHATE ANHYDROUS (1)

164 SOLIFENACIN SUCCINATE (1)

165 TAMSULOSIN HYDROCHLORIDE USP (1)

166 TELMISARTAN USP (1)

167 TERAZOSIN HYDROCHLORIDE ANHYDROUS (1)

168 TERIFLUNOMIDE (1)

169 TIZANIDINE HYDROCHLORIDE USP (1)

170 TOFACITINIB CITRATE (1)

171 TOPIRAMATE USP (1)

172 TRAMADOL HYDROCHLORIDE (1)

173 TRAMADOL HYDROCHLORIDE USP (1)

174 TRAZODONE HYDROCHLORIDE USP (1)

175 VALSARTAN USP (2)

176 VENLAFAXINE HYDROCHLORIDE PH EUR (1)

177 VENLAFAXINE HYDROCHLORIDE USP (1)

178 VILAZODONE HYDROCHLORIDE (1)

179 VILOXAZINE HYDROCHLORIDE (1)

180 VORTIOXETINE HYDROBROMIDE (1)

181 WARFARIN SODIUM USP (CRYSTALLINE CLATHRATE) (1)

182 ZALEPLON (1)

183 ZIPRASIDONE HYDROCHLORIDE ANHYDROUS (1)

184 ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USP (1)

185 ZOLPIDEM TARTRATE (1)

186 ZONISAMIDE (1)

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01 CADILA HEALTHCARE LTD (62)

02 CADILA HEALTHCARE LTD ZYFINE (1)

03 ZYDUS LIFESCIENCES LTD (125)

04 ZYDUS WORLDWIDE DMCC (1)

05 ZYFINE DIV CADILA HEALTHCARE LTD (1)

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01 India (190)

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01 Active (132)

02 Inactive (58)

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01 Complete (85)

02 Blank (105)

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