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

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01 7-ACCA (1)

02 7-ADCA (1)

03 7-AMINO-3-VINYL 3-CEPHEM-4-CARBOXYLIC ACID(7-AVCA) (1)

04 7-APCA INTERMEDIATE (1)

05 ABACAVIR SULFATE USP (1)

06 ABACAVIR SULFATE USP (PROCESS-2) (1)

07 ALENDRONATE SODIUM USP (1)

08 AMLODIPINE BESILATE USP (1)

09 APREMILAST (1)

10 APREMILAST (FORM M) (1)

11 ARMODAFINIL (1)

12 ASENAPINE MALEATE (MICRONIZED) (1)

13 ATAZANAVIR SULFATE (1)

14 ATAZANAVIR SULFATE (PROCESS B) (1)

15 ATORVASTATIN (1)

16 ATORVASTATIN CALCIUM AMORPHOUS USP (1)

17 ATORVASTATIN CALCIUM TRIHYDRATE USP (1)

18 AZILSARTAN KAMEDOXOMIL (1)

19 AZITHROMYCIN DIHYDRATE USP (1)

20 AZITHROMYCIN MONOHYDRATE USP (1)

21 AZITHROMYCIN MONOHYDRATE USP (PROCESS B) (1)

22 BENAZEPRIL HYDROCHLORIDE (1)

23 BENAZEPRIL HYDROCHLORIDE USP (PROCESS B) (1)

24 BICALUTAMIDE (1)

25 BICTEGRAVIR SODIUM (MICRONIZED) (1)

26 BIMATOPROST (1)

27 BREXPIPRAZOLE (1)

28 BRIMONIDINE TARTRATE (1)

29 BRIVARACETAM (1)

30 BUPROPION HYDROBROMIDE (1)

31 BUPROPION HYDROCHLORIDE USP (1)

32 CALCIUM L-5-METHYLTETRAHYDROFOLATE USP (1)

33 CANAGLIFLOZIN (1)

34 CANAGLIFLOZIN HEMIHYDRATE (1)

35 CARVEDILOL (1)

36 CARVEDILOL PHOSPHATE (AMORPHOUS) (1)

37 CEFACLOR USP AS MAUFACTURED IN MANDIDEEP, INDIA (1)

38 CEFADROXIL USP (1)

39 CEFDINIR MONOHYDRATE USP (1)

40 CEFDITOREN PIVOXIL (1)

41 CEFIXIME USP (1)

42 CEFPROZIL USP (1)

43 CEFTRIAXONE SODIUM USP (STERILE ) (1)

44 CEFUROXIME ACID (1)

45 CEFUROXIME AXETIL (AMORPHOUS) USP (1)

46 CEFUROXIME AXETIL (CRYSTALLINE) USP (1)

47 CELECOXIB USP (1)

48 CEPHALEXIN (1)

49 CEPHALEXIN USP (1)

50 CHOLINE FENOFIBRATE (1)

51 CINACALCET HYDROCHLORIDE (1)

52 CLINDAMYCIN PALMITATE HYDROCHLORIDE USP (1)

53 CLOPIDOGREL BISULFATE USP (1)

54 COLESEVELAM HYDROCHLORIDE (1)

55 CYSTEAMINE BITARTRATE (1)

56 DABIGATRAN ETEXILATE MESYLATE (1)

57 DAPAGLIFLOZIN PREMIX (1)

58 DARUNAVIR (AMORPHOUS) (1)

59 DARUNAVIR ETHANOLATE (1)

60 DARUNAVIR ETHANOLATE (PROCESS-B) (1)

61 DARUNAVIR N-PROPANOLATE (1)

62 DESLORATADINE USP (1)

63 DESOGESTREL (1)

64 DESVENLAFAXINE BENZOATE (1)

65 DESVENLAFAXINE SUCCINATE (1)

66 DEUTETRABENAZINE (1)

67 DEXLANSOPRAZOLE (1)

68 DIENOGEST (1)

69 DOLUTEGRAVIR SODIUM ( PROCESS B) (1)

70 DOLUTEGRAVIR SODIUM (PROCESS A) (1)

71 DONEPEZIL HYDROCHLORIDE USP (1)

72 DOXERCALCIFEROL (1)

73 DRONEDARONE HYDROCHLORIDE USP (1)

74 DROSPIRENONE USP (1)

75 DROXIDOPA (1)

76 DULOXETINE HYDROCHLORIDE USP (1)

77 DULOXETINE HYDROCHLORIDE USP (PROCESS B) (1)

78 EFAVIRENZ USP (1)

79 EFINACONAZOLE (1)

80 ELAGOLIX SODIUM (1)

81 EMPAGLIFLOZIN (1)

82 EMTRICITABINE (1)

83 ESCITALOPRAM OXALATE USP (1)

84 ESLICARBAZEPINE ACETATE (1)

85 ESOMEPRAZOLE MAGNESIUM DIHYDRATE USP (1)

86 ESTRADIOL HEMIHYDRATE USP (1)

87 ESTRADIOL VALERATE USP (1)

88 ESZOPICLONE USP (1)

89 ETHAMBUTOL HYDROCHLORIDE USP (1)

90 ETHINYL ESTRADIOL USP (1)

91 EZETIMIBE (1)

92 EZETIMIBE USP (PROCESS-B) (1)

93 EZETIMIBE USP (PROCESS-C) (1)

94 FEBUXOSTAT (MICRONIZED) (1)

95 FEBUXOSTAT (PROCESS-B) (1)

96 FENOFIBRATE USP (1)

97 FENOFIBRATE-SLS MIXTURE (1)

98 FERRIC CITRATE (1)

99 FERRIC CITRATE (PROCESS-B) (1)

100 FESOTERODINE FUMARATE (1)

101 FLUTICASONE FUROATE (1)

102 FLUTICASONE PROPIONATE USP (1)

103 FLUVASTATIN SODIUM (MICRONIZED) USP (1)

104 FOSAMPRENAVIR CALCIUM (1)

105 GATIFLOXACIN (1)

106 GLIPIZIDE USP (1)

107 GLYCEROL PHENYLBUTYRATE (1)

108 HYDROCORTISONE VALERATE USP (1)

109 IDELALISIB (1)

110 ILOPERIDONE (1)

111 IMIPRAMINE HYDROCHLORIDE USP (1)

112 IMIPRAMINE PAMOATE USP (1)

113 IRBESARTAN USP (1)

114 IRBESARTAN USP (PROCESS B) (1)

115 IVACAFTOR (1)

116 L-5-METHYL TETRAHYDROFOLATE CALCIUM (AMORPHOUS) (1)

117 LACOSAMIDE (1)

118 LAMIVUDINE (PROCESS-B) (1)

119 LAMIVUDINE USP (1)

120 LAMOTRIGINE USP (MICRONISED) (1)

121 LANSOPRAZOLE USP (1)

122 LATANOPROST USP (1)

123 LEDIPASVIR (1)

124 LETERMOVIR (1)

125 LEVETIRACETAM USP (1)

126 LEVOFLOXACIN HEMIHYDRATE USP (1)

127 LEVONORGESTREL USP (1)

128 LEVOTHYROXINE SODIUM USP (1)

129 LISINOPRIL USP (1)

130 LORCASERIN HYDROCHLORIDE PREMIX (1)

131 LOSARTAN POTASSIUM USP (AMORPHOUS) (1)

132 LOSARTAN POTASSIUM USP (CRYSTALLINE) (1)

133 LOVASTATIN (1)

134 LOVASTATIN TECHNICAL (1)

135 LOVASTATIN USP (1)

136 LURASIDONE HYDROCHLORIDE (1)

137 MEMANTINE HYDROCHLORIDE USP (1)

138 MESALAMINE USP (2)

139 METAXALONE USP (1)

140 METFORMIN HYDROCHLORIDE USP (1)

141 METHYLPREDNISOLONE SODIUM SUCCINATE (1)

142 MIGALASTAT HYDROCHLORIDE (1)

143 MILNACIPRAN HYDROCHLORIDE (1)

144 MIRABEGRON (1)

145 NABUMETONE (MICRONISED) USP (1)

146 NORETHINDRONE ACETATE USP (1)

147 NORETHINDRONE USP (1)

148 NORGESTIMATE USP (1)

149 NORGESTREL USP (1)

150 OLMESARTAN MEDOXOMIL USP (1)

151 OMEPRAZOLE MAGNESIUM (1)

152 OMEPRAZOLE USP (1)

153 OSELTAMIVIR PHOSPHATE USP (1)

154 PALIPERIDONE (1)

155 PANTOPRAZOLE SODIUM SESQUIHYDRATE (1)

156 PERINDOPRIL TERT-BUTYLAMINE (1)

157 PIOGLITAZONE HYDROCHLORIDE (1)

158 PIRFENIDONE (1)

159 PITAVASTATIN CALCIUM (1)

160 PITAVASTATIN SODIUM (1)

161 PRASUGREL HYDROCHLORIDE USP (1)

162 PREGABALIN (1)

163 PREGABALIN (PROCESS-B) USP (1)

164 PROPRANOLOL HYDROCHLORIDE USP (1)

165 QUETIAPINE FUMARATE USP (1)

166 QUINAPRIL HYDROCHLORIDE USP (1)

167 RABEPRAZOLE SODIUM USP (1)

168 RALTEGRAVIR POTASSIUM USP (1)

169 RALTEGRAVIR POTASSIUM USP (CRYSTALLINE) (1)

170 RAMIPRIL USP (1)

171 RAMIPRIL USP (PROCESS B) (1)

172 RANOLAZINE (1)

173 RIFABUTIN USP (1)

174 RIFAMPIN USP (1)

175 RIFAMYCIN O (1)

176 RIFAMYCIN-S (BULK SUBSTANCE) (1)

177 RIFAXIMIN (1)

178 RIFAXIMIN (PROCESS B) (1)

179 RISPERIDONE USP (1)

180 RITONAVIR COPOVIDONE (1)

181 RITONAVIR USP (2)

182 RIVAROXABAN (1)

183 ROSUVASTATIN CALCIUM (1)

184 RUFINAMIDE USP (1)

185 SACUBITRIL CALCIUM (1)

186 SACUBITRIL/VALSARTAN COMPLEX (1)

187 SERTRALINE HYDROCHLORIDE USP (1)

188 SEVELAMER CARBONATE (1)

189 SEVELAMER HYDROCHLORIDE (1)

190 SIMVASTATIN USP (1)

191 SITAGLIPTIN PHOSPHATE ANHYDROUS USP (1)

192 SODIUM ZIRCONIUM CYCLOSILICATE (1)

193 SOFOSBUVIR PREMIX (1)

194 STERILE CEFEPIME HYDROCHLORIDE (BUFFERED) (1)

195 STERILE CEFEPIME HYDROCHLORIDE USP (1)

196 STERILE CEFOTAXIME SODIUM USP (1)

197 SUCROFERRIC OXYHYDROXIDE (1)

198 TELMISARTAN USP (1)

199 TENOFOVIR ALAFENAMIDE FUMARATE (1)

200 TENOFOVIR ALAFENAMIDE FUMARATE (PROCESS-B) (1)

201 TENOFOVIR DISOPROXIL FUMARATE (1)

202 TESTOSTERONE USP (1)

203 TIOTROPIUM BROMIDE MONOHYDRATE (1)

204 TOLTERODINE TARTRATE USP (1)

205 TOLVAPTAN (1)

206 TOPIRAMATE USP (1)

207 TRANDOLAPRIL USP (1)

208 TRAVOPROST USP (1)

209 UMECLIDINIUM BROMIDE (1)

210 VALACYCLOVIR HYDROCHLORIDE (1)

211 VALBENAZINE TOSYLATE (1)

212 VALSARTAN USP (1)

213 VARENICLINE TARTRATE (1)

214 VENLAFAXINE HYDROCHLORIDE USP (1)

215 VILANTEROL TRIFENATATE (1)

216 VILAZODONE HYDROCHLORIDE (1)

217 VORTIOXETINE HYDROBROMIDE (1)

218 WARFARIN POTASSIUM (1)

219 ZIPRASIDONE HYDROCHLORIDE USP (1)

220 ZOLPIDEM TARTRATE USP (1)

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01 LUPIN LTD (181)

02 LUPIN MANUFACTURING SOLUTIONS LIMITED (3)

03 LUPIN MANUFACTURING SOLUTIONS LTD (38)

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01 India (222)

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01 Active (154)

02 Inactive (68)

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01 Complete (92)

02 Blank (130)

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