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

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01 ABACAVIR SULFATE (1)

02 ABACAVIR SULFATE (PROCESS-II), USP (1)

03 ABIRATERONE ACETATE (1)

04 ACYCLOVIR (1)

05 AFATINIB DIMALEATE (1)

06 AFATINIB DIMALEATE (FORM A) (1)

07 ALECTINIB HYDROCHLORIDE (1)

08 ALFUZOSIN HYDROCHLORIDE (1)

09 ALLOPURINOL (1)

10 AMIFAMPRIDINE PHOSPHATE (1)

11 AMLODIPINE BESILATE (1)

12 AMLODIPINE BESYLATE (1)

13 AMLODIPINE BESYLATE (PROCESS-II) (1)

14 ANASTROZOLE USP (1)

15 APALUTAMIDE (1)

16 APREMILAST (FORM-B) (1)

17 APREPITANT (1)

18 ARIPIPRAZOLE PROCESS II (1)

19 ARIPIPRAZOLE PROCESS-I (1)

20 ATAZANAVIR SULFATE (1)

21 ATOMOXETINE HYDROCHLORIDE (1)

22 ATORVASTATIN CALCIUM AMORPHOUS (1)

23 ATORVASTATIN CALCIUM TRIHYDRATE (FORM I) (1)

24 ATOVAQUONE (FORM-A) (1)

25 AZACITIDINE (1)

26 BENDAMUSTINE HYDROCHLORIDE MONOHYDRATE USP (1)

27 BEXAROTENE (1)

28 BICALUTAMIDE (FORM-H1) (1)

29 BICTEGRAVIR SODIUM (1)

30 BORTEZOMIB (FORM-II) (2)

31 BUPROPION HYDROCHLORIDE (1)

32 BUPROPION HYDROCHLORIDE (PROCESS-II) (1)

33 CABAZITAXEL (1)

34 CANDESARTAN CILEXETIL (1)

35 CAPECITABINE, USP (1)

36 CARBIDOPA (1)

37 CARBOPLATIN USP (1)

38 CEFPROZIL MONOHYDRATE (1)

39 CELECOXIB (1)

40 CINACALCET HYDROCHLORIDE (1)

41 CISPLATIN USP (1)

42 CITALOPRAM HYDROBROMIDE (PROCESS I) (1)

43 CITALOPRAM HYDROBROMIDE (PROCESS II) (1)

44 CLOPIDOGREL BISULFATE (FORM-I) (1)

45 CYCLOBENZAPRINE HYDROCHLORIDE (1)

46 CYCLOPHOSPHAMIDE MONOHYDRATE, USP (1)

47 DABIGATRAN ETEXILATE MESYLATE (1)

48 DACLATASVIR DIHYDROCHLORIDE (1)

49 DAROLUTAMIDE PREMIX (1)

50 DARUNAVIR AMORPHOUS (1)

51 DARUNAVIR AMORPHOUS (PROCESS-II) (1)

52 DARUNAVIR ETHANOLATE (1)

53 DARUNAVIR ETHANOLATE (PROCESS-II) (1)

54 DASATINIB ANHYDROUS (1)

55 DEUTETRABENAZINE (1)

56 DEXLANSOPRAZOLE (1)

57 DEXLANSOPRAZOLE SESQUIHYDRATE (1)

58 DIDANOSINE (1)

59 DIVALPROEX SODIUM (1)

60 DOLUTEGRAVIR SODIUM (1)

61 DOLUTEGRAVIR SODIUM (PROCESS-II) (1)

62 DONEPEZIL HYDROCHLORIDE (ANHYDROUS) (1)

63 DONEPEZIL HYDROCHLORIDE (MONOHYDRATE) (1)

64 DORAVIRINE PREMIX (1)

65 DORZOLAMIDE HYDROCHLORIDE ( PROCESS I ) (1)

66 DORZOLAMIDE HYDROCHLORIDE (PROCESS II) (1)

67 DULOXETINE HYDROCHLORIDE (1)

68 DUTASTERIDE (1)

69 Desvenlafaxine Succinate (1)

70 EFAVIRENZ (PROCESS I) (1)

71 EFAVIRENZ (PROCESS II) (1)

72 EFAVIRENZ (PROCESS III) USP (1)

73 EFAVIRENZ(FORM-H1) (1)

74 ELAGOLIX SODIUM (1)

75 ELETRIPTAN HYDROBROMIDE (1)

76 ELTROMBOPAG OLAMINE (1)

77 EMTRICITABINE (1)

78 EMTRICITABINE (PROCESS-II) (1)

79 ENTACAPONE (1)

80 ENTECAVIR MONOHYDRATE (1)

81 ENZALUTAMIDE (1)

82 EPLERENONE (1)

83 EPROSARTAN MESYLATE (1)

84 ERLOTINIB HYDROCHLORIDE (1)

85 ESCITALOPRAM OXALATE (PROCESS II) (1)

86 ESCITALOPRAM OXALATE (PROCESS-I) (1)

87 ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE PELLETS (AS 20.94%W/W OF ESOMEPRAZOLE) (1)

88 ESOMEPRAZOLE MAGNESIUM DIHYDRATE (1)

89 ESOMEPRAZOLE MAGNESIUM DIHYDRATE (PROCESS-III) (1)

90 ESOMEPRAZOLE MAGNESIUM DIHYDRATE PROCESS II (1)

91 ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (1)

92 ESOMEPRAZOLE SODIUM (1)

93 ETORICOXIB (1)

94 ETRAVIRINE (1)

95 ETRAVIRINE PREMIX (1)

96 EZETIMIBE (1)

97 EZETIMIBE (FORM-B) (1)

98 FAMCICLOVIR (1)

99 FAMOTIDINE (1)

100 FEBUXOSTAT (FORM-H1) (1)

101 FELBAMATE (1)

102 FENOFIBRATE, USP (1)

103 FESOTERODINE FUMARATE (1)

104 FEXOFENADINE HYDROCHLORIDE (1)

105 FINASTERIDE (1)

106 FOSAPREPITANT DIMEGLUMINE (1)

107 FOSINOPRIL SODIUM (1)

108 FOSTAMATINIB DISODIUM HEXAHYDRATE (1)

109 GABAPENTIN (1)

110 GABAPENTIN (PROCESS-II) (1)

111 GATIFLOXACIN HEMIHYDRATE (1)

112 GEFITINIB (1)

113 GEMCITABINE HYDROCHLORIDE USP (1)

114 GLIMEPIRIDE (1)

115 GLYCEROL PHENYLBUTYRATE (1)

116 HYDRALAZINE HYDROCHLORIDE (1)

117 HYDRALAZINE HYDROCHLORIDE, USP (PARENTERAL GRADE) (1)

118 IBRUTINIB (FORM-A) (1)

119 IMATINIB MESYLATE (FORM-A) (1)

120 IMATINIB MESYLATE (FORM-B) (1)

121 IMATINIB MESYLATE AMORPHOUS (1)

122 INDOMETHACIN (1)

123 IRBESARTAN (FORM A) PROCESS I (1)

124 IRBESARTAN (FORM A) PROCESS II (1)

125 IRINOTECAN HYDROCHLORIDE TRIHYDRATE, USP (FORM B) (1)

126 IRON SUCROSE (1)

127 ISOTRETINOIN (1)

128 ITRACONAZOLE (1)

129 IVABRADINE HYDROCHLORIDE (1)

130 LACOSAMIDE (1)

131 LAMIVUDINE USP (PROCESS I) (1)

132 LAMIVUDINE USP(PROCESS II) (1)

133 LAMIVUDINE, USP (FORM I) (1)

134 LANSOPRAZOLE (1)

135 LAPATINIB DITOSYLATE MONOHYDRATE (1)

136 LENALIDOMIDE (FORM-H1) (1)

137 LETROZOLE USP (1)

138 LEVETIRACETAM (FORM 1) (1)

139 LEVETIRACETAM (FORM-1), PROCESS-II (1)

140 LEVODOPA (1)

141 LEVOFLOXACIN HEMIHYDRATE, USP (1)

142 LEVOMILNACIPRAN HYDROCHLORIDE (1)

143 LISINOPRIL (1)

144 LISINOPRIL PROCESS-III (1)

145 LOPINAVIR (PROCESS-II) (1)

146 LOPINAVIR AMORPHOUS (1)

147 LOPINAVIR USP (1)

148 LOSARTAN POTASSIUM (FORM 1) (1)

149 LURASIDONE HYDROCHLORIDE (1)

150 MARAVIROC (FORM-B) (1)

151 MARAVIROC AMORPHOUS (1)

152 MELPHALAN HYDROCHLORIDE (1)

153 MEMANTINE HYDROCHLORIDE (1)

154 METAXALONE (1)

155 METOPROLOL SUCCINATE (1)

156 MEXILETINE HYDROCHLORIDE (1)

157 MIDOSTAURIN (1)

158 MILNACIPRAN HYDROCHLORIDE (1)

159 MIRABEGRON (FORM-B) (1)

160 MIRTAZAPINE (1)

161 MONTELUKAST SODIUM (1)

162 MOXIFLOXACIN HYDROCHLORIDE (1)

163 MOXIFLOXACIN HYDROCHLORIDE ANHYDROUS (1)

164 NABUMETONE (1)

165 NAPROXEN (1)

166 NAPROXEN SODIUM (1)

167 NEBIVOLOL HYDROCHLORIDE (1)

168 NEBIVOLOL HYDROCHLORIDE (PROCESS-II) (1)

169 NEVIRAPINE (1)

170 NEVIRAPINE ANHYDROUS (1)

171 NILOTINIB HYDROCHLORIDE DIHYDRATE (1)

172 NINTEDANIB ESYLATE (1)

173 OBETICHOLIC ACID (1)

174 OLANZAPINE (FORM-1) (1)

175 OLAPARIB (1)

176 OLMESARTAN MEDOXOMIL (1)

177 OMEPRAZOLE (1)

178 OMEPRAZOLE MAGNESIUM (1)

179 OMEPRAZOLE USP (FORM B) (1)

180 OSELTAMIVIR PHOSPHATE (1)

181 OSIMERTINIB MESYLATE (1)

182 OXALIPLATIN USP (1)

183 PACLITAXEL USP (1)

184 PALBOCICLIB (1)

185 PANTOPRAZOLE SODIUM SESQUIHYDRATE (1)

186 PANTOPRAZOLE SODIUM SESQUIHYDRATE, USP (PROCESS II) (1)

187 PAZOPANIB HYDROCHLORIDE (1)

188 PEMETREXED DISODIUM 2.5 HYDRATE (1)

189 PERINDOPRIL TERT-BUTYLAMINE (1)

190 PIOGLITAZONE HYDROCHLORIDE (1)

191 PIOGLITAZONE HYDROCHLORIDE (PROCESS-II) (1)

192 PITAVASTATIN CALCIUM (1)

193 PLERIXAFOR (1)

194 POMALIDOMIDE (1)

195 PRALATREXATE (1)

196 PRAMIPEXOLE DIHYDROCHLORIDE (1)

197 PRASUGREL HYDROCHLORIDE (1)

198 PREGABALIN (1)

199 PROGUANIL HYDROCHLORIDE, USP (1)

200 QUETIAPINE FUMARATE (2)

201 QUETIAPINE FUMARATE (PROCESS II) (1)

202 RABEPRAZOLE SODIUM (1)

203 RALOXIFENE HYDROCHLORIDE USP (1)

204 RALTEGRAVIR POTASSIUM (1)

205 RALTEGRAVIR POTASSIUM (FORM-III) (1)

206 RAMIPRIL (1)

207 REGORAFENIB (1)

208 RILPIVIRINE HYDROCHLORIDE (1)

209 RILUZOLE (1)

210 RISEDRONATE SODIUM HEMI-PENTAHYDRATE, USP (1)

211 RITONAVIR PREMIX AMORPHOUS (1)

212 RITONAVIR USP (1)

213 RITONAVIR USP (FORM I), PROCESS II (1)

214 RITONAVIR, USP (FORM I), PROCESS I (1)

215 RIVAROXABAN (1)

216 RIZATRIPTAN BENZOATE USP (1)

217 ROFLUMILAST (1)

218 ROSUVASTATIN CALCIUM (AMORPHOUS) (1)

219 RUFINAMIDE (1)

220 SAQUINAVIR MESYLATE, USP (1)

221 SAXAGLIPTIN HYDROCHLORIDE PREMIX (1)

222 SELENIOUS ACID (1)

223 SERTRALINE HCL USP (FORM II PROCESS I) (1)

224 SERTRALINE HYDROCHLORIDE, USP (FORM 1) (1)

225 SERTRALINE HYDROCHLORIDE, USP (FORM II), PROCESS II (1)

226 SEVELAMER CARBONATE (2)

227 SEVELAMER HYDROCHLORIDE (1)

228 SILDENAFIL CITRATE (1)

229 SILODOSIN (1)

230 SIMVASTATIN (1)

231 SIMVASTATIN, USP (PROCESS II) (1)

232 SODIUM ZIRCONIUM CYCLOSILICATE (1)

233 SOLIFENACIN SUCCINATE (1)

234 SOLRIAMFETOL HYDROCHLORIDE (1)

235 SORAFENIB TOSYLATE USP (1)

236 STAVUDINE (1)

237 SUNITINIB MALATE (1)

238 TELMISARTAN, USP (FORM A) (1)

239 TEMOZOLOMIDE, USP (1)

240 TENOFOVIR ALAFENAMIDE HEMIFUMARATE (1)

241 TENOFOVIR DISOPROXIL FUMARATE (1)

242 TENOFOVIR DISOPROXIL FUMARATE (PROCESS II) (1)

243 TERBINAFINE HYDROCHLORIDE (1)

244 TETRABENAZINE (1)

245 THALIDOMIDE USP (1)

246 TIPIRACIL HYDROCHLORIDE (1)

247 TIZANIDINE HYDROCHLORIDE (1)

248 TOLTERODINE TARTRATE (1)

249 TOLVAPTAN (1)

250 TOLVAPTAN POVIDONE PREMIX (1)

251 TOPIRAMATE (1)

252 TORSEMIDE (1)

253 TRANDOLAPRIL (1)

254 VALACYCLOVIR HYDROCHLORIDE MONOHYDRATE (1)

255 VALGANCICLOVIR HYDROCHLORIDE, USP (1)

256 VALSARTAN (1)

257 VALSARTAN (PROCESS II) (1)

258 VALSARTAN (PROCESS-III) (1)

259 VENLAFAXINE HYDROCHLORIDE (1)

260 VIGABATRIN (1)

261 VORICONAZOLE (FORM-I) (1)

262 VORTIOXETINE HYDROBROMIDE (1)

263 Varenicline Tartrate (1)

264 ZAFIRLUKAST (AMORPHOUS) (1)

265 ZIDOVUDINE (PROCESS I) (1)

266 ZIDOVUDINE (PROCESS II) (1)

267 ZIPRASIDONE HYDROCHLORIDE, USP (1)

268 ZOLEDRONIC ACID MONOHYDRATE (1)

269 ZOLMITRIPTAN (1)

270 ZONISAMIDE (1)

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