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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 ALFUZOSIN HYDROCHLORIDE (1)

08 ALLOPURINOL (1)

09 AMIFAMPRIDINE PHOSPHATE (1)

10 AMLODIPINE BESILATE (1)

11 AMLODIPINE BESYLATE (1)

12 AMLODIPINE BESYLATE (PROCESS-II) (1)

13 ANASTROZOLE USP (1)

14 APALUTAMIDE (1)

15 APREMILAST (FORM-B) (1)

16 APREPITANT (1)

17 ARIPIPRAZOLE PROCESS II (1)

18 ARIPIPRAZOLE PROCESS-I (1)

19 ATAZANAVIR SULFATE (1)

20 ATOMOXETINE HYDROCHLORIDE (1)

21 ATORVASTATIN CALCIUM AMORPHOUS (1)

22 ATORVASTATIN CALCIUM TRIHYDRATE (FORM I) (1)

23 ATOVAQUONE (FORM-A) (1)

24 AZACITIDINE (1)

25 BENDAMUSTINE HYDROCHLORIDE MONOHYDRATE USP (1)

26 BEXAROTENE (1)

27 BICALUTAMIDE (FORM-H1) (1)

28 BICTEGRAVIR SODIUM (1)

29 BORTEZOMIB (FORM-II) (2)

30 BUPROPION HYDROCHLORIDE (1)

31 BUPROPION HYDROCHLORIDE (PROCESS-II) (1)

32 CABAZITAXEL (1)

33 CANDESARTAN CILEXETIL (1)

34 CAPECITABINE, USP (1)

35 CARBIDOPA (1)

36 CARBOPLATIN USP (1)

37 CEFPROZIL MONOHYDRATE (1)

38 CELECOXIB (1)

39 CINACALCET HYDROCHLORIDE (1)

40 CISPLATIN USP (1)

41 CITALOPRAM HYDROBROMIDE (PROCESS I) (1)

42 CITALOPRAM HYDROBROMIDE (PROCESS II) (1)

43 CLOPIDOGREL BISULFATE (FORM-I) (1)

44 CYCLOBENZAPRINE HYDROCHLORIDE (1)

45 CYCLOPHOSPHAMIDE MONOHYDRATE, USP (1)

46 DABIGATRAN ETEXILATE MESYLATE (1)

47 DACLATASVIR DIHYDROCHLORIDE (1)

48 DAROLUTAMIDE PREMIX (1)

49 DARUNAVIR AMORPHOUS (1)

50 DARUNAVIR AMORPHOUS (PROCESS-II) (1)

51 DARUNAVIR ETHANOLATE (1)

52 DARUNAVIR ETHANOLATE (PROCESS-II) (1)

53 DASATINIB ANHYDROUS (1)

54 DEUTETRABENAZINE (1)

55 DEXLANSOPRAZOLE (1)

56 DEXLANSOPRAZOLE SESQUIHYDRATE (1)

57 DIDANOSINE (1)

58 DIVALPROEX SODIUM (1)

59 DOLUTEGRAVIR SODIUM (1)

60 DOLUTEGRAVIR SODIUM (PROCESS-II) (1)

61 DONEPEZIL HYDROCHLORIDE (ANHYDROUS) (1)

62 DONEPEZIL HYDROCHLORIDE (MONOHYDRATE) (1)

63 DORAVIRINE PREMIX (1)

64 DORZOLAMIDE HYDROCHLORIDE ( PROCESS I ) (1)

65 DORZOLAMIDE HYDROCHLORIDE (PROCESS II) (1)

66 DULOXETINE HYDROCHLORIDE (1)

67 DUTASTERIDE (1)

68 Desvenlafaxine Succinate (1)

69 EFAVIRENZ (PROCESS I) (1)

70 EFAVIRENZ (PROCESS II) (1)

71 EFAVIRENZ (PROCESS III) USP (1)

72 EFAVIRENZ(FORM-H1) (1)

73 ELAGOLIX SODIUM (1)

74 ELETRIPTAN HYDROBROMIDE (1)

75 ELTROMBOPAG OLAMINE (1)

76 EMTRICITABINE (1)

77 EMTRICITABINE (PROCESS-II) (1)

78 ENTACAPONE (1)

79 ENTECAVIR MONOHYDRATE (1)

80 ENZALUTAMIDE (1)

81 EPLERENONE (1)

82 EPROSARTAN MESYLATE (1)

83 ERLOTINIB HYDROCHLORIDE (1)

84 ESCITALOPRAM OXALATE (PROCESS II) (1)

85 ESCITALOPRAM OXALATE (PROCESS-I) (1)

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

87 ESOMEPRAZOLE MAGNESIUM DIHYDRATE (1)

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

89 ESOMEPRAZOLE MAGNESIUM DIHYDRATE PROCESS II (1)

90 ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (1)

91 ESOMEPRAZOLE SODIUM (1)

92 ETORICOXIB (1)

93 ETRAVIRINE (1)

94 ETRAVIRINE PREMIX (1)

95 EZETIMIBE (1)

96 EZETIMIBE (FORM-B) (1)

97 FAMCICLOVIR (1)

98 FAMOTIDINE (1)

99 FEBUXOSTAT (FORM-H1) (1)

100 FELBAMATE (1)

101 FENOFIBRATE, USP (1)

102 FESOTERODINE FUMARATE (1)

103 FEXOFENADINE HYDROCHLORIDE (1)

104 FINASTERIDE (1)

105 FOSAPREPITANT DIMEGLUMINE (1)

106 FOSINOPRIL SODIUM (1)

107 FOSTAMATINIB DISODIUM HEXAHYDRATE (1)

108 GABAPENTIN (1)

109 GABAPENTIN (PROCESS-II) (1)

110 GATIFLOXACIN HEMIHYDRATE (1)

111 GEFITINIB (1)

112 GEMCITABINE HYDROCHLORIDE USP (1)

113 GLIMEPIRIDE (1)

114 GLYCEROL PHENYLBUTYRATE (1)

115 HYDRALAZINE HYDROCHLORIDE (1)

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

117 IBRUTINIB (FORM-A) (1)

118 IMATINIB MESYLATE (FORM-A) (1)

119 IMATINIB MESYLATE (FORM-B) (1)

120 IMATINIB MESYLATE AMORPHOUS (1)

121 INDOMETHACIN (1)

122 IRBESARTAN (FORM A) PROCESS I (1)

123 IRBESARTAN (FORM A) PROCESS II (1)

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

125 ISOTRETINOIN (1)

126 ITRACONAZOLE (1)

127 IVABRADINE HYDROCHLORIDE (1)

128 LACOSAMIDE (1)

129 LAMIVUDINE USP (PROCESS I) (1)

130 LAMIVUDINE USP(PROCESS II) (1)

131 LAMIVUDINE, USP (FORM I) (1)

132 LANSOPRAZOLE (1)

133 LAPATINIB DITOSYLATE MONOHYDRATE (1)

134 LENALIDOMIDE (FORM-H1) (1)

135 LETROZOLE USP (1)

136 LEVETIRACETAM (FORM 1) (1)

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

138 LEVODOPA (1)

139 LEVOFLOXACIN HEMIHYDRATE, USP (1)

140 LEVOMILNACIPRAN HYDROCHLORIDE (1)

141 LISINOPRIL (1)

142 LISINOPRIL PROCESS-III (1)

143 LOPINAVIR (PROCESS-II) (1)

144 LOPINAVIR AMORPHOUS (1)

145 LOPINAVIR USP (1)

146 LOSARTAN POTASSIUM (FORM 1) (1)

147 LURASIDONE HYDROCHLORIDE (1)

148 MARAVIROC (FORM-B) (1)

149 MARAVIROC AMORPHOUS (1)

150 MELPHALAN HYDROCHLORIDE (1)

151 MEMANTINE HYDROCHLORIDE (1)

152 METAXALONE (1)

153 METOPROLOL SUCCINATE (1)

154 MEXILETINE HYDROCHLORIDE (1)

155 MIDOSTAURIN (1)

156 MILNACIPRAN HYDROCHLORIDE (1)

157 MIRABEGRON (FORM-B) (1)

158 MIRTAZAPINE (1)

159 MONTELUKAST SODIUM (1)

160 MOXIFLOXACIN HYDROCHLORIDE (1)

161 MOXIFLOXACIN HYDROCHLORIDE ANHYDROUS (1)

162 NABUMETONE (1)

163 NAPROXEN (1)

164 NAPROXEN SODIUM (1)

165 NEBIVOLOL HYDROCHLORIDE (1)

166 NEBIVOLOL HYDROCHLORIDE (PROCESS-II) (1)

167 NEVIRAPINE (1)

168 NEVIRAPINE ANHYDROUS (1)

169 NILOTINIB HYDROCHLORIDE DIHYDRATE (1)

170 NINTEDANIB ESYLATE (1)

171 OBETICHOLIC ACID (1)

172 OLANZAPINE (FORM-1) (1)

173 OLAPARIB (1)

174 OLMESARTAN MEDOXOMIL (1)

175 OMEPRAZOLE (1)

176 OMEPRAZOLE MAGNESIUM (1)

177 OMEPRAZOLE, USP (FORM B) (1)

178 OSELTAMIVIR PHOSPHATE (1)

179 OSIMERTINIB MESYLATE (1)

180 OXALIPLATIN USP (1)

181 PACLITAXEL USP (1)

182 PALBOCICLIB (1)

183 PANTOPRAZOLE SODIUM SESQUIHYDRATE (1)

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

185 PAZOPANIB HYDROCHLORIDE (1)

186 PEMETREXED DISODIUM 2.5 HYDRATE (1)

187 PERINDOPRIL TERT-BUTYLAMINE (1)

188 PIOGLITAZONE HYDROCHLORIDE (1)

189 PIOGLITAZONE HYDROCHLORIDE (PROCESS-II) (1)

190 PITAVASTATIN CALCIUM (1)

191 PLERIXAFOR (1)

192 POMALIDOMIDE (1)

193 PRALATREXATE (1)

194 PRAMIPEXOLE DIHYDROCHLORIDE (1)

195 PRASUGREL HYDROCHLORIDE (1)

196 PREGABALIN (1)

197 PROGUANIL HYDROCHLORIDE, USP (1)

198 QUETIAPINE FUMARATE (2)

199 QUETIAPINE FUMARATE (PROCESS II) (1)

200 RABEPRAZOLE SODIUM (1)

201 RALOXIFENE HYDROCHLORIDE USP (1)

202 RALTEGRAVIR POTASSIUM (1)

203 RALTEGRAVIR POTASSIUM (FORM-III) (1)

204 RAMIPRIL (1)

205 REGORAFENIB (1)

206 RILPIVIRINE HYDROCHLORIDE (1)

207 RILUZOLE (1)

208 RISEDRONATE SODIUM HEMI-PENTAHYDRATE, USP (1)

209 RITONAVIR PREMIX AMORPHOUS (1)

210 RITONAVIR USP (1)

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

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

213 RIVAROXABAN (1)

214 RIZATRIPTAN BENZOATE USP (1)

215 ROFLUMILAST (1)

216 ROSUVASTATIN CALCIUM (AMORPHOUS) (1)

217 RUFINAMIDE (1)

218 SAQUINAVIR MESYLATE, USP (1)

219 SAXAGLIPTIN HYDROCHLORIDE PREMIX (1)

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

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

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

223 SEVELAMER CARBONATE (2)

224 SEVELAMER HYDROCHLORIDE (1)

225 SILDENAFIL CITRATE (1)

226 SILODOSIN (1)

227 SIMVASTATIN (1)

228 SIMVASTATIN, USP (PROCESS II) (1)

229 SODIUM ZIRCONIUM CYCLOSILICATE (1)

230 SOLIFENACIN SUCCINATE (1)

231 SOLRIAETOL HYDROCHLORIDE (1)

232 SORAFENIB TOSYLATE USP (1)

233 STAVUDINE (1)

234 SUNITINIB MALATE (1)

235 TELMISARTAN, USP (FORM A) (1)

236 TEMOZOLOMIDE, USP (1)

237 TENOFOVIR ALAFENAMIDE HEMIFUMARATE (1)

238 TENOFOVIR DISOPROXIL FUMARATE (1)

239 TENOFOVIR DISOPROXIL FUMARATE (PROCESS II) (1)

240 TERBINAFINE HYDROCHLORIDE (1)

241 TETRABENAZINE (1)

242 THALIDOMIDE USP (1)

243 TIPIRACIL HYDROCHLORIDE (1)

244 TIZANIDINE HYDROCHLORIDE (1)

245 TOLTERODINE TARTRATE (1)

246 TOLVAPTAN (1)

247 TOPIRAMATE (1)

248 TORSEMIDE (1)

249 TRANDOLAPRIL (1)

250 VALACYCLOVIR HYDROCHLORIDE MONOHYDRATE (1)

251 VALGANCICLOVIR HYDROCHLORIDE, USP (1)

252 VALSARTAN (1)

253 VALSARTAN (PROCESS II) (1)

254 VALSARTAN (PROCESS-III) (1)

255 VENLAFAXINE HYDROCHLORIDE (1)

256 VIGABATRIN (1)

257 VORICONAZOLE (FORM-I) (1)

258 VORTIOXETINE HYDROBROMIDE (1)

259 Varenicline Tartrate (1)

260 ZAFIRLUKAST (AMORPHOUS) (1)

261 ZIDOVUDINE (PROCESS I) (1)

262 ZIDOVUDINE (PROCESS II) (1)

263 ZIPRASIDONE HYDROCHLORIDE, USP (1)

264 ZOLEDRONIC ACID MONOHYDRATE (1)

265 ZOLMITRIPTAN (1)

266 ZONISAMIDE (1)

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