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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 ABACAVIR SULFATE USP (PROCESS II) (1)

07 ABIRATERONE ACETATE USP (1)

08 ACETAMINOPHEN USP (1)

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

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

11 AMIODARONE HYDROCHLORIDE (1)

12 AMLODIPINE BESYLATE USP (1)

13 AMOXICILLIN SODIUM (NON-STERILE) (1)

14 AMOXICILLIN SODIUM (STERILE) BULK (1)

15 AMOXICILLIN USP (1)

16 AMOXICILLIN USP (ENZYME ROUTE) (1)

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

18 AMPICILLIN SODIUM USP (STERILE) BULK (1)

19 AMPICILLIN TRIHYDRATE USP (ENZYME ROUTE) (1)

20 AMPICILLIN TRIHYDRATE, USP (1)

21 APALUTAMIDE PREMIX (1)

22 APIXABAN (1)

23 APREMILAST (1)

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

25 ARIPIPRAZOLE USP (PROCESS II) (1)

26 ARMODAFINIL (1)

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

28 ATOMOXETINE HYDROCHLORIDE USP (1)

29 ATORVASTATIN CALCIUM USP (1)

30 ATOVAQUONE USP (1)

31 AZACITIDINE (1)

32 AZILSARTAN KAMEDOXOMIL (1)

33 AZTREONAM USP (1)

34 BARICITINIB (1)

35 BEMPEDOIC ACID (1)

36 BENAZEPRIL HYDROCHLORIDE USP (1)

37 BISOPROLOL FUMARATE USP (1)

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

39 BREXPIPRAZOLE (1)

40 BUPROPION HYDROCHLORIDE USP (1)

41 CALCITONIN SALMON USP (1)

42 CANAGLIFLOZIN (1)

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

44 CARIPRAZINE HYDROCHLORIDE PREMIX (1)

45 CARISOPRODOL USP (1)

46 CARMUSTINE USP (1)

47 CARVEDILOL USP (1)

48 CEFACLOR USP (1)

49 CEFADROXIL USP (1)

50 CEFAZOLIN SODIUM USP (1)

51 CEFDINIR USP (ANHYDROUS) (1)

52 CEFDINIR USP (CRYSTAL B) (1)

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

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

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

56 CEFOTAXIME SODIUM (STERILE) (1)

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

58 CEFOXITIN SODIUM USP (STERILE BULK) (1)

59 CEFPODOXIME PROXETIL USP (1)

60 CEFPODOXIME PROXETIL USP (PROCESS II) (1)

61 CEFPROZIL USP (1)

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

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

64 CEFTRIAXONE SODIUM (1)

65 CEFTRIAXONE SODIUM (STERILE) (1)

66 CEFUROXIME ACID (1)

67 CEFUROXIME AXETIL USP (1)

68 CEFUROXIME SODIUM (1)

69 CEFUROXIME SODIUM (STERILE) USP (1)

70 CELECOXIB USP (1)

71 CENOBAMATE (1)

72 CEPHALEXIN USP (1)

73 CEPHALEXIN USP (ENZYMATIC ROUTE) (1)

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

75 CILASTATIN SODIUM USP (STERILE) (1)

76 CINACALCET HYDROCHLORIDE (1)

77 CIPROFLOXACIN HYDROCHLORIDE USP (1)

78 CITALOPRAM HYDROBROMIDE USP (1)

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

80 CLINDAMYCIN HYDROCHLORIDE USP (1)

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

82 CLOPIDOGREL BISULFATE USP (1)

83 CLOPIDOGREL BISULFATE USP (FORM II) (1)

84 COLESEVELAM HYDROCHLORIDE (1)

85 DABIGATRAN ETEXILATE MESYLATE (1)

86 DALFAMPRIDINE (1)

87 DAPAGLIFLOZIN (1)

88 DARIFENACIN HYDROBROMIDE (1)

89 DARUNAVIR PROPYLENE GLYCOLATE (1)

90 DASATINIB (1)

91 DEFERASIROX (1)

92 DEGARELIX (1)

93 DESMOPRESSIN ACETATE USP (1)

94 DEUTETRABENAZINE (1)

95 DEXRAZOXANE (1)

96 DEXTROMETHORPHAN HYDROBROMIDE USP (1)

97 DEXTROMETHORPHAN POLISTIREX (1)

98 DICHLORPHENAMIDE USP (1)

99 DICLOXACILLIN SODIUM USP (1)

100 DIDANOSINE USP (1)

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

102 DIMETHYL FUMARATE (1)

103 DIVALPROEX SODIUM USP (1)

104 DOCOSANOL (1)

105 DOFETILIDE USP (1)

106 DOLUTEGRAVIR SODIUM (1)

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

108 DORIPENEM MONOHYDRATE (STERILE) (1)

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

110 DRONEDARONE HYDROCHLORIDE USP (1)

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

112 DULOXETINE HYDROCHLORIDE USP (PROCESS II) (1)

113 DUTASTERIDE USP (1)

114 EFAVIRENZ USP (1)

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

116 ELETRIPTAN HYDROBROMIDE (1)

117 ELTROMBOPAG OLAMINE (1)

118 ELUXADOLINE (1)

119 EMPAGLIFLOZIN (1)

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

121 ENCORAFENIB (1)

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

123 ENTECAVIR (1)

124 ERTAPENEM SODIUM (1)

125 ERTUGLIFLOZIN L-PYROGLUTAMIC ACID (1)

126 ERYTHROMYCIN LACTOBIONATE (1)

127 ESCITALOPRAM OXALATE USP (1)

128 ESLICARBAZEPINE ACETATE (1)

129 ESOMEPRAZOLE MAGNESIUM DIHYDRATE (1)

130 ESOMEPRAZOLE MAGNESIUM DIHYDRATE (PROCESS II) (1)

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

132 ETELCALCETIDE HYDROCHLORIDE (1)

133 EZETIMIBE USP (1)

134 EZETIMIBE USP (PROCESS-II) (1)

135 FAMCICLOVIR USP (1)

136 FAMOTIDINE USP (1)

137 FEBUXOSTAT (1)

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

139 FEXOFENADINE HYDROCHLORIDE USP (1)

140 FINASTERIDE USP (1)

141 FLECAINIDE ACETATE USP (1)

142 FLUCONAZOLE USP (1)

143 FLUOXETINE HYDROCHLORIDE USP (1)

144 FLUOXETINE HYDROCHLORIDE USP (PROCESS II) (1)

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

146 FONDAPARINUX SODIUM USP (1)

147 FOSAPREPITANT DIMEGLUMINE (1)

148 FOSCARNET SODIUM USP (1)

149 FOSINOPRIL SODIUM USP (1)

150 GABAPENTIN ENACARBIL (1)

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

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

153 GANCICLOVIR USP (1)

154 GANIRELIX ACETATE (1)

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

156 GEMFIBROZIL USP (1)

157 GLATIRAMER ACETATE (1)

158 GLYBURIDE USP (1)

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

160 HYDRALAZINE HYDROCHLORIDE USP (1)

161 HYDROCHLOROTHIAZIDE USP (1)

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

163 ICATIBANT ACETATE (1)

164 IMATINIB MESYLATE (1)

165 IMIPENEM USP (STERILE) (1)

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

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

168 ISOPROTERENOL HYDROCHLORIDE (1)

169 ISOSULFAN BLUE (1)

170 IVACAFTOR (1)

171 IVACAFTOR PREMIX (1)

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

173 LACOSAMIDE USP (CIP PROCESS) (1)

174 LAMIVUDINE (1)

175 LAMIVUDINE USP (2)

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

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

178 LENALIDOMIDE (1)

179 LEUPROLIDE ACETATE USP (1)

180 LEVETIRACETAM USP (1)

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

182 LIFITEGRAST (1)

183 LINACLOTIDE (1)

184 LINAGLIPTIN (1)

185 LIRAGLUTIDE (1)

186 LISINOPRIL USP (1)

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

188 LORCASERIN HYDROCHLORIDE HEMIHYDRATE (1)

189 LOSARTAN POTASSIUM USP DRUG SUBSTANCE (1)

190 LURASIDONE HYDROCHLORIDE (1)

191 MACITENTAN (1)

192 MELOXICAM USP (1)

193 MELPHALAN HYDROCHLORIDE (1)

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

195 MEROPENEM FOR INJECTION (STERILE BULK) (1)

196 MESALAMINE USP (1)

197 METFORMIN HYDROCHLORIDE USP (1)

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

199 METOPROLOL SUCCINATE USP (1)

200 METOPROLOL TARTRATE USP (1)

201 MIGALASTAT HYDROCHLORIDE (1)

202 MIRABEGRON (1)

203 MIRTAZAPINE ANHYDROUS USP (1)

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

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

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

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

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

209 NALOXEGOL OXALATE PREMIX (1)

210 NAPROXEN SODIUM USP NON STERILE DRUG SUBSTANCE (1)

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

212 NELFINAVIR MESYLATE (1)

213 NEOSTIGMINE METHYLSULFATE USP (1)

214 NEVIRAPINE ANHYDROUS USP (2)

215 NEVIRAPINE ANHYDROUS USP (PROCESS II) (1)

216 NEVIRAPINE HEMIHYDRATE USP (1)

217 OCTREOTIDE ACETATE (1)

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

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

220 OLMESARTAN MEDOXOMIL USP (1)

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

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

223 ONDANSETRON HYDROCHLORIDE USP (1)

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

225 OXACILLIN SODIUM USP (1)

226 OXYBUTYNIN CHLORIDE (1)

227 PACLITAXEL USP (1)

228 PALIPERIDONE PALMITATE (1)

229 PALIPERIDONE USP (1)

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

231 PANTOPRAZOLE SODIUM SESQUIHYDRATE USP (1)

232 PANTOPRAZOLE SODIUM USP (PROCESS-II) (1)

233 PAROXETINE HYDROCHLORIDE (HEMIHYDRATE) USP (1)

234 PENICILLAMINE USP (1)

235 PENTOXIFYLLINE USP (1)

236 PERINDOPRIL TERT-BUTYLAMINE DRUG SUBSTANCE (1)

237 PHENOXYBENZAMINE HYDROCHLORIDE USP (1)

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

239 PIPERACILLIN USP (1)

240 PIRFENIDONE (1)

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

242 PLECANATIDE (1)

243 PRAMIPEXOLE DIHYDROCHLORIDE USP (1)

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

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

246 PYRIMETHAMINE USP (1)

247 QUETIAPINE FUMARATE (1)

248 QUETIAPINE FUMARATE USP (PROCESS II) (1)

249 QUINAPRIL HYDROCHLORIDE USP (1)

250 RABEPRAZOLE SODIUM (1)

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

252 RALTEGRAVIR POTASSIUM USP (1)

253 RAMELTEON (1)

254 RAMIPRIL USP (1)

255 RANOLAZINE (1)

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

257 REVEFENACIN (1)

258 RIBAVIRIN USP (1)

259 RIMEGEPANT SULFATE (1)

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

261 RISPERIDONE USP (1)

262 RITONAVIR USP (1)

263 RIVAROXABAN (1)

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

265 RIVASTIGMINE USP (1)

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

267 ROFLUMILAST (1)

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

269 SACUBITRIL-VALSARTAN PREMIX (1)

270 SAFINAMIDE MESYLATE (1)

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

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

273 SERTRALINE HYDROCHLORIDE USP CRYSTALLINE POLYMORPH FORM I (1)

274 SEVELAMER CARBONATE (1)

275 SEVELAMER HYDROCHLORIDE (1)

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

277 SILODOSIN (1)

278 SIMVASTATIN USP (1)

279 SIPONIMOD FUMARIC ACID (1)

280 SITAGLIPTIN PHOSPHATE (1)

281 SODIUM BICARBONATE (STERILE) (1)

282 SODIUM NITROPRUSSIDE USP (1)

283 SOLIFENACIN SUCCINATE (1)

284 SOLRIAMFETOL HYDROCHLORIDE (1)

285 SORAFENIB TOSYLATE USP (1)

286 STAVUDINE USP (1)

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

288 SUGAMMADEX SODIUM (1)

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

290 SULBACTAM SODIUM USP (STERILE) BULK (1)

291 SULBACTAM SODIUM USP (STERILE) PROCESS-II (1)

292 SUMATRIPTAN SUCCINATE USP (1)

293 SUMATRIPTAN SUCCINATE USP (PROCESS II) (1)

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

295 TAFAMIDIS (1)

296 TAFAMIDIS MEGLUMINE (1)

297 TAMSULOSIN HCI USP (1)

298 TAZOBACTAM HEMIHYDRATE USP (1)

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

300 TENOFOVIR ALAFENAMIDE FUMARATE (1)

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

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

303 TERBINAFINE HYDROCHLORIDE USP (1)

304 TERIFLUNOMIDE (1)

305 TERIPARATIDE (1)

306 TEZACAFTOR PREMIX (1)

307 TIPIRACIL HYDROCHLORIDE (1)

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

309 TOPIRAMATE USP (1)

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

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

312 TRAMETINIB ACETIC ACID (1)

313 TRANDOLAPRIL USP (1)

314 TRIFLURIDINE USP (1)

315 TRIHEPTANOIN (1)

316 UBROGEPANT (1)

317 UPADACITINIB (1)

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

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

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

321 VALSARTAN USP (PROCESS II) (1)

322 VASOPRESSIN USP (1)

323 VIGABATRIN USP (1)

324 VORICONAZOLE USP (1)

325 ZALEPLON USP (1)

326 ZIDOVUDINE USP (2)

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

328 ZIPRASIDONE MESYLATE TRIHYDRATE (1)

329 ZOLMITRIPTAN (1)

330 ZOLPIDEM TARTRATE USP (1)

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01 APITORIA PHARMA PRIVATE LIMITED (2)

02 APITORIA PHARMA PRIVATE LTD (249)

03 ARENE LIFE SCIENCES PRIVATE LTD (2)

04 AURO PEPTIDES LTD (14)

05 AUROBINDO DATONG BIO PHARMA CO LTD (1)

06 AUROBINDO PHARMA LTD (60)

07 AURONEXT PHARMA PRIVATE LTD (4)

08 EUGIA PHARMA SPECIALITIES LTD (1)

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