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

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01 10-METHOXY IMINOSTILBENE (1)

02 6 AMINO PENICILLANIC ACID (1)

03 6-AMINO PENICILLANIC ACID DRUG SUBSTANCE INTERMEDIATE (1)

04 7-AMINO DESACETOXY CEPHALOSPORANIC ACID (7-ADCA) (1)

05 ABACAVIR SULFATE USP (1)

06 ABIRATERONE ACETATE USP (1)

07 ACETAMINOPHEN USP (1)

08 ALENDRONATE SODIUM USP (NON-STERILE DRUG SUBSTANCE) (1)

09 ALFUZOSIN HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) (1)

10 AMIODARONE HYDROCHLORIDE (1)

11 AMLODIPINE BESYLATE USP (1)

12 AMOXICILLIN SODIUM (NON-STERILE) (1)

13 AMOXICILLIN SODIUM (STERILE) BULK (1)

14 AMOXICILLIN USP (1)

15 AMOXICILLIN USP (ENZYME ROUTE) (1)

16 AMPICILLIN AND SULBACTAM FOR INJECTION USP (STERILE BULK MIXTURE 2:1) (1)

17 AMPICILLIN SODIUM USP (STERILE) BULK (1)

18 AMPICILLIN TRIHYDRATE USP (ENZYME ROUTE) (1)

19 AMPICILLIN TRIHYDRATE, USP (1)

20 APALUTAMIDE PREMIX (1)

21 APIXABAN (1)

22 APREMILAST (1)

23 ARIPIPRAZOLE USP (NON-STERILE DRUG SUBSTANCE) (1)

24 ARIPIPRAZOLE USP (PROCESS II) (1)

25 ARMODAFINIL (1)

26 ATAZANAVIR SULFATE USP (NON-STERILE DRUG SUBSTANCE) (1)

27 ATOMOXETINE HYDROCHLORIDE USP (1)

28 ATORVASTATIN CALCIUM USP (1)

29 ATOVAQUONE USP (1)

30 AZACITIDINE (1)

31 AZILSARTAN KAMEDOXOMIL (1)

32 AZTREONAM USP (1)

33 BARICITINIB (1)

34 BEMPEDOIC ACID (1)

35 BENAZEPRIL HYDROCHLORIDE USP (1)

36 BISOPROLOL FUMARATE USP (1)

37 BOSENTAN MONOHYDRATE (NON-STERILE DRUG SUBSTANCE) (1)

38 BREXPIPRAZOLE (1)

39 BUPROPION HYDROCHLORIDE USP (1)

40 CALCITONIN SALMON USP (1)

41 CANAGLIFLOZIN (1)

42 CANDESARTAN CILEXETIL (NON STERILE DRUG SUBSTANCE) (1)

43 CARIPRAZINE HYDROCHLORIDE PREMIX (1)

44 CARISOPRODOL USP (1)

45 CARMUSTINE USP (1)

46 CARVEDILOL USP (1)

47 CEFACLOR USP (1)

48 CEFADROXIL USP (1)

49 CEFAZOLIN SODIUM USP (1)

50 CEFDINIR USP (CRYSTAL B) (1)

51 CEFEPIME FOR INJECTION USP (STERILE BULK) (1)

52 CEFEPIME HYDROCHLORIDE, NON-STERILE INTERMEDIATE DRUG SUBSTANCE (1)

53 CEFIXIME USP (NON-STERILE DRUG SUBSTANCE) (1)

54 CEFOTAXIME SODIUM (STERILE) (1)

55 CEFOXITIN ACID (NON-STERILE DRUG SUBSTANCE INTERMEDIATE) (1)

56 CEFOXITIN SODIUM USP (STERILE BULK) (1)

57 CEFPODOXIME PROXETIL USP (1)

58 CEFPROZIL USP (1)

59 CEFTAZIDIME DIHYDROCHLORIDE, NON-STERILE DRUG SUBSTANCE INTERMEDIATE (1)

60 CEFTAZIDIME FOR INJECTION USP (STERILE BULK) (1)

61 CEFTRIAXONE SODIUM (1)

62 CEFTRIAXONE SODIUM (STERILE) (1)

63 CEFUROXIME ACID (1)

64 CEFUROXIME AXETIL USP (1)

65 CEFUROXIME SODIUM (1)

66 CEFUROXIME SODIUM (STERILE) USP (1)

67 CELECOXIB USP (1)

68 CENOBAMATE (1)

69 CEPHALEXIN USP (1)

70 CEPHALEXIN USP (ENZYMATIC ROUTE) (1)

71 CEPHALOTHIN ACID (NON-STERILE DRUG SUBSTANCE INTERMEDIATE) (1)

72 CILASTATIN SODIUM USP (STERILE) (1)

73 CINACALCET HYDROCHLORIDE (1)

74 CIPROFLOXACIN HYDROCHLORIDE USP (1)

75 CITALOPRAM HYDROBROMIDE USP (1)

76 CITALOPRAM HYDROBROMIDE USP (ROUTE-1) (1)

77 CLINDAMYCIN HYDROCHLORIDE USP (1)

78 CLINDAMYCIN PALMITATE HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) (1)

79 CLOPIDOGREL BISULFATE USP (1)

80 CLOPIDOGREL BISULFATE USP (FORM II) (1)

81 COLESEVELAM HYDROCHLORIDE (1)

82 DABIGATRAN ETEXILATE MESYLATE (1)

83 DALFAMPRIDINE (1)

84 DAPAGLIFLOZIN (1)

85 DARIFENACIN HYDROBROMIDE (1)

86 DARUNAVIR PROPYLENE GLYCOLATE (1)

87 DASATINIB (1)

88 DEFERASIROX (1)

89 DEGARELIX (1)

90 DESMOPRESSIN ACETATE USP (1)

91 DEUTETRABENAZINE (1)

92 DEXRAZOXANE (1)

93 DEXTROMETHORPHAN HYDROBROMIDE USP (1)

94 DEXTROMETHORPHAN POLISTIREX (1)

95 DICHLORPHENAMIDE USP (1)

96 DICLOXACILLIN SODIUM USP (1)

97 DIDANOSINE USP (1)

98 DIDANOSINE USP, NON-STERILE DRUG SUBSTANCE (1)

99 DIMETHYL FUMARATE (1)

100 DIVALPROEX SODIUM USP (1)

101 DOCOSANOL (1)

102 DOFETILIDE USP (1)

103 DOLUTEGRAVIR SODIUM (1)

104 DONEPEZIL HYDROCHLORIDE USP, NON-STERILE DRUG SUBSTANCE (1)

105 DORIPENEM MONOHYDRATE (STERILE) (1)

106 DOXAZOSIN MESYLATE USP (NON-STERILE DRUG SUBSTANCE) (1)

107 DRONEDARONE HYDROCHLORIDE USP (1)

108 DULOXETINE HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) (1)

109 DULOXETINE HYDROCHLORIDE USP (PROCESS II) (1)

110 DUTASTERIDE USP (1)

111 EFAVIRENZ USP (1)

112 EFAVIRENZ USP (NON-STERILE DRUG SUBSTANCE) (1)

113 ELETRIPTAN HYDROBROMIDE (1)

114 ELTROMBOPAG OLAMINE (1)

115 ELUXADOLINE (1)

116 EMPAGLIFLOZIN (1)

117 EMTRICITABINE (NON-STERILE) DRUG SUBSTANCE (1)

118 ENCORAFENIB (1)

119 ENTACAPONE USP (NON-STERILE DRUG SUBSTANCE) (1)

120 ENTECAVIR (1)

121 ERTAPENEM SODIUM (1)

122 ERTUGLIFLOZIN L-PYROGLUTAMIC ACID (1)

123 ERYTHROMYCIN LACTOBIONATE (1)

124 ESCITALOPRAM OXALATE USP (1)

125 ESLICARBAZEPINE ACETATE (1)

126 ESOMEPRAZOLE MAGNESIUM DIHYDRATE (1)

127 ESOMEPRAZOLE MAGNESIUM DIHYDRATE (PROCESS II) (1)

128 ESOMEPRAZOLE SODIUM (NON-STERILE DRUG SUBSTANCE) (1)

129 ETELCALCETIDE HYDROCHLORIDE (1)

130 EZETIMIBE USP (1)

131 EZETIMIBE USP (PROCESS-II) (1)

132 FAMCICLOVIR USP (1)

133 FAMOTIDINE USP (1)

134 FEBUXOSTAT (1)

135 FELODIPINE USP, NON-STERILE DRUG SUBSTANCE (1)

136 FEXOFENADINE HYDROCHLORIDE USP (1)

137 FINASTERIDE USP (1)

138 FLECAINIDE ACETATE USP (1)

139 FLUCONAZOLE USP (1)

140 FLUOXETINE HYDROCHLORIDE USP (1)

141 FLUOXETINE HYDROCHLORIDE USP (PROCESS II) (1)

142 FLUVASTATIN SODIUM USP (NON-STERILE DRUG SUBSTANCE) (1)

143 FONDAPARINUX SODIUM USP (1)

144 FOSAPREPITANT DIMEGLUMINE (1)

145 FOSCARNET SODIUM USP (1)

146 FOSINOPRIL SODIUM USP (1)

147 GABAPENTIN ENACARBIL (1)

148 GABAPENTIN USP (NON-STERILE DRUG SUBSTANCE) (1)

149 GALANTAMINE HYDROBROMIDE USP (NON-STERILE DRUG SUBSTANCE) (1)

150 GANCICLOVIR USP (1)

151 GANIRELIX ACETATE (1)

152 GATIFLOXACIN HEMIHYDRATE (NON-STERILE DRUG SUBSTANCE) (1)

153 GEIBROZIL USP (1)

154 GLATIRAMER ACETATE (1)

155 GLYBURIDE USP (1)

156 GLYCOPYRROLATE USP, NON-STERILE DRUG SUBSTANCE (1)

157 HYDRALAZINE HYDROCHLORIDE USP (1)

158 HYDROCHLOROTHIAZIDE USP (1)

159 IBANDRONATE SODIUM (NON-STERILE DRUG SUBSTANCE) (1)

160 ICATIBANT ACETATE (1)

161 IMATINIB MESYLATE (1)

162 IMIPENEM USP (STERILE) (1)

163 INDINAVIR SULFATE USP (NON-STERILE DRUG SUBSTANCE) (1)

164 IRBESARTAN USP (NON-STERILE DRUG SUBSTANCE) (1)

165 ISOPROTERENOL HYDROCHLORIDE (1)

166 ISOSULFAN BLUE (1)

167 IVACAFTOR (1)

168 IVACAFTOR PREMIX (1)

169 LACOSAMIDE (NON-STERILE DRUG SUBSTANCE) (1)

170 LAMIVUDINE (1)

171 LAMIVUDINE USP (2)

172 LAMIVUDINE USP (CRYSTALLINE POLYMORPH FORM I) (1)

173 LAMOTRIGINE USP (NON-STERILE DRUG SUBSTANCE) (1)

174 LENALIDOMIDE (1)

175 LEUPROLIDE ACETATE USP (1)

176 LEVETIRACETAM USP (1)

177 LEVOFLOXACIN USP (NON-STERILE DRUG SUBSTANCE) (1)

178 LIFITEGRAST (1)

179 LINACLOTIDE (1)

180 LINAGLIPTIN (1)

181 LIRAGLUTIDE (1)

182 LISINOPRIL USP (1)

183 LOPINAVIR USP (NON STERILE DRUG SUBSTANCE) (1)

184 LORCASERIN HYDROCHLORIDE HEMIHYDRATE (1)

185 LOSARTAN POTASSIUM USP DRUG SUBSTANCE (1)

186 LURASIDONE HYDROCHLORIDE (1)

187 MACITENTAN (1)

188 MELOXICAM USP (1)

189 MELPHALAN HYDROCHLORIDE (1)

190 MEROPENEM (NON-STERILE DRUG SUBSTANCE INTERMEDIATE) (1)

191 MEROPENEM FOR INJECTION (STERILE BULK) (1)

192 MESALAMINE USP (1)

193 METFORMIN HYDROCHLORIDE USP (1)

194 METHENAMINE HIPPURATE USP (NON-STERILE DRUG SUBSTANCE) (1)

195 METOPROLOL SUCCINATE USP (1)

196 METOPROLOL TARTRATE USP (1)

197 MIGALASTAT HYDROCHLORIDE (1)

198 MIRABEGRON (1)

199 MIRTAZAPINE ANHYDROUS USP (1)

200 MODAFINIL USP (NON-STERILE DRUG SUBSTANCE) (1)

201 MONTELUKAST SODIUM USP (NON-STERILE DRUG SUBSTANCE) (1)

202 MOXIFLOXACIN HYDROCHLORIDE USP (NON STERILE DRUG SUBSTANCE) (1)

203 NAFCILLIN FOR INJECTION USP (STERILE) BULK (1)

204 NAFCILLIN SODIUM (NON-STERILE DRUG SUBSTANCE INTERMEDIATE) (1)

205 NALOXEGOL OXALATE PREMIX (1)

206 NAPROXEN SODIUM USP NON STERILE DRUG SUBSTANCE (1)

207 NAPROXEN USP (NON STERILE DRUG SUBSTANCE) (1)

208 NELFINAVIR MESYLATE (1)

209 NEOSTIGMINE METHYLSULFATE USP (1)

210 NEVIRAPINE ANHYDROUS USP (2)

211 NEVIRAPINE ANHYDROUS USP (PROCESS II) (1)

212 NEVIRAPINE HEMIHYDRATE USP (1)

213 OCTREOTIDE ACETATE (1)

214 OLANZAPINE USP (CRYSTALLINE POLYMORPH FORM-II) (1)

215 OLANZAPINE USP (NON-STERILE DRUG SUBSTANCE) (1)

216 OLMESARTAN MEDOXOMIL USP (1)

217 OMEPRAZOLE MAGNESIUM USP (NON STERILE DRUG SUBSTANCE) (1)

218 OMEPRAZOLE USP (NON-STERILE DRUG SUBSTANCE) (1)

219 ONDANSETRON HYDROCHLORIDE USP (1)

220 OXACILLIN FOR INJECTION USP (STERILE BULK) (1)

221 OXACILLIN SODIUM USP (1)

222 OXYBUTYNIN CHLORIDE (1)

223 PACLITAXEL USP (1)

224 PALIPERIDONE PALMITATE (1)

225 PALIPERIDONE USP (1)

226 PALONOSETRON HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE) (1)

227 PANTOPRAZOLE SODIUM SESQUIHYDRATE USP (1)

228 PAROXETINE HYDROCHLORIDE (HEMIHYDRATE) USP (1)

229 PENICILLAMINE USP (1)

230 PENTOXIFYLLINE USP (1)

231 PERINDOPRIL TERT-BUTYLAMINE DRUG SUBSTANCE (1)

232 PHENOXYBENZAMINE HYDROCHLORIDE USP (1)

233 PIOGLITAZONE HYDROCHLORIDE USP (NON STERILE DRUG SUBSTANCE) (1)

234 PIPERACILLIN USP (1)

235 PIRFENIDONE (1)

236 PITAVASTATIN CALCIUM (NON-STERILE DRUG SUBSTANCE) (1)

237 PLECANATIDE (1)

238 PRAMIPEXOLE DIHYDROCHLORIDE USP (1)

239 PRASUGREL HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) (1)

240 PREGABALIN USP (NON-STERILE DRUG SUBSTANCE) (1)

241 PYRIMETHAMINE USP (1)

242 QUETIAPINE FUMARATE (1)

243 QUETIAPINE FUMARATE USP (PROCESS II) (1)

244 QUINAPRIL HYDROCHLORIDE USP (1)

245 RABEPRAZOLE SODIUM (1)

246 RALOXIFENE HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) (1)

247 RAMELTEON (1)

248 RAMIPRIL USP (1)

249 RANOLAZINE (1)

250 REPAGLINIDE USP (NON-STERILE DRUG SUBSTANCE) (1)

251 REVEFENACIN (1)

252 RIBAVIRIN USP (1)

253 RIMEGEPANT SULFATE (1)

254 RISEDRONATE SODIUM HEMIPENTAHYDRATE USAP (NON-STERILE DRUG SUBSTANCE) (1)

255 RISPERIDONE USP (1)

256 RITONAVIR USP (1)

257 RIVAROXABAN (1)

258 RIVASTIGMINE TARTRATE USP (NON-STERILE DRUG SUBSTANCE) (1)

259 RIVASTIGMINE USP (1)

260 RIZATRIPTAN BENZOATE USP (NON-STERILE DRUG SUBSTANCE) (1)

261 ROFLUMILAST (1)

262 ROSUVASTATIN CALCIUM (NON-STERILE DRUG SUBSTANCE) (1)

263 SACUBITRIL-VALSARTAN PREMIX (1)

264 SAFINAMIDE MESYLATE (1)

265 SAXAGLIPTIN MONOHYDRATE (NON-STERILE DRUG SUBSTANCE) (1)

266 SERTRALINE HYDROCHLORIDE USP (CRYSTALLINE POLYMORPH FORM II) (1)

267 SERTRALINE HYDROCHLORIDE USP CRYSTALLINE POLYMORPH FORM I (1)

268 SEVELAMER CARBONATE (1)

269 SEVELAMER HYDROCHLORIDE (1)

270 SILDENAFIL CITRATE USP (NON-STERILE DRUG SUBSTANCE) (1)

271 SILODOSIN (1)

272 SIMVASTATIN USP (1)

273 SIPONIMOD FUMARIC ACID (1)

274 SITAGLIPTIN PHOSPHATE (1)

275 SODIUM BICARBONATE (STERILE) (1)

276 SODIUM NITROPRUSSIDE USP (1)

277 SOLIFENACIN SUCCINATE (1)

278 SOLRIAETOL HYDROCHLORIDE (1)

279 SORAFENIB TOSYLATE USP (1)

280 STAVUDINE USP (1)

281 STAVUDINE USP (NON-STERILE DRUG SUBSTANCE) (1)

282 SUGAMMADEX SODIUM (1)

283 SULBACTAM SODIUM USP (NON-STERILE BULK) (1)

284 SULBACTAM SODIUM USP (STERILE) BULK (1)

285 SUMATRIPTAN SUCCINATE USP (1)

286 SUMATRIPTAN SUCCINATE USP (PROCESS II) (1)

287 TADALAFIL USP (NON-STERILE DRUG SUBSTANCE) (1)

288 TAFAMIDIS (1)

289 TAFAMIDIS MEGLUMINE (1)

290 TAMSULOSIN HCI USP (1)

291 TAZOBACTAM HEMIHYDRATE USP (1)

292 TELMISARTAN USP (NON-STERILE DRUG SUBSTANCE) (1)

293 TENOFOVIR ALAFENAMIDE FUMARATE (1)

294 TENOFOVIR DISOPROXIL FUMARATE (NON-STERILE DRUG SUBSTANCE) (1)

295 TERAZOSIN HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) (1)

296 TERBINAFINE HYDROCHLORIDE USP (1)

297 TERIFLUNOMIDE (1)

298 TERIPARATIDE (1)

299 TEZACAFTOR PREMIX (1)

300 TIPIRACIL HYDROCHLORIDE (1)

301 TOLTERODINE TARTRATE, NON-STERILE DRUG SUBSTANCE (1)

302 TOPIRAMATE USP (1)

303 TORSEMIDE USP (NON-STERILE DRUG SUBSTANCE) (1)

304 TRAMADOL HYDROCHLORIDE USP (NON STERILE DRUG SUBSTANCE) (1)

305 TRAMETINIB ACETIC ACID (1)

306 TRANDOLAPRIL USP (1)

307 TRIFLURIDINE USP (1)

308 UBROGEPANT (1)

309 UPADACITINIB (1)

310 VALACYCLOVIR HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) (1)

311 VALGANCICLOVIR HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) (1)

312 VALSARTAN USP (NON-STERILE DRUG SUBSTANCE) (1)

313 VALSARTAN USP (PROCESS II) (1)

314 VASOPRESSIN USP (1)

315 VIGABATRIN USP (1)

316 VORICONAZOLE USP (1)

317 ZALEPLON USP (1)

318 ZIDOVUDINE USP (2)

319 ZIPRASIDONE HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) (1)

320 ZIPRASIDONE MESYLATE TRIHYDRATE (1)

321 ZOLMITRIPTAN (1)

322 ZOLPIDEM TARTRATE USP (1)

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02 APITORIA PHARMA PRIVATE LTD (145)

03 ARENE LIFE SCIENCES PRIVATE LTD (2)

04 AURO PEPTIDES LTD (14)

05 AUROBINDO DATONG BIO PHARMA CO LTD (1)

06 AUROBINDO PHARMA LTD (155)

07 AURONEXT PHARMA PRIVATE LTD (4)

08 EUGIA PHARMA SPECIALITIES LTD (1)

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01 India (325)

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01 Active (292)

02 Inactive (33)

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01 Complete (225)

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