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

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01 16A-BROMOEPIANDROSTERONE (1)

02 ABACAVIR SULFATE USP (1)

03 ABIRATERONE ACETATE (1)

04 ABIRATERONE ACETATE USP (1)

05 ACALABRUTINIB (1)

06 ACALABRUTINIB MALEATE (1)

07 ACYCLOVIR (1)

08 ADEFOVIR DIPIVOXIL (1)

09 ALBENDAZOLE (B) USP (1)

10 ALBENDAZOLE USP (1)

11 ALBUTEROL (1)

12 ALBUTEROL SULFATE USP (2)

13 ALENDRONATE SODIUM USP (1)

14 ALFUZOSIN HYDROCHLORIDE (1)

15 ALOSETRON HYDROCHLORIDE USP (1)

16 ALPRAZOLAM USP (1)

17 AMBRISENTAN (1)

18 AMLODIPINE BESYLATE USP (1)

19 AMLODIPINE MESYLATE MONOHYDRATE (1)

20 ANAGRELIDE HYDROCHLORIDE MONOHYDRATE USP (1)

21 ANASTROZOLE USP (1)

22 APREMILAST (1)

23 ARFORMOTEROL TARTRATE (1)

24 ARIPIPRAZOLE (1)

25 ARTEMETHER (1)

26 ARTESUNATE (1)

27 ATAZANAVIR SULPHATE (1)

28 ATAZANAVIR SULPHATE (METHANOL ROUTE) (1)

29 AZELASTINE HYDROCHLORIDE BP/PH.EUR (1)

30 BECLOMETHASONE DIPROPIONATE (1)

31 BECLOMETHASONE DIPROPIONATE USP (ANHYDROUS) (1)

32 BICALUTAMIDE USP (1)

33 BICTEGRAVIR SODIUM (1)

34 BORTEZOMIB (1)

35 BOSENTAN MONOHYDRATE (1)

36 BREXPIPRAZOLE (1)

37 BUDESONIDE USP (1)

38 CABOTEGRAVIR (1)

39 CABOTEGRAVIR SODIUM (1)

40 CAPECITABINE USP (1)

41 CARBOPLATIN USP (1)

42 CARVEDILOL USP (1)

43 CELECOXIB USP (1)

44 CETIRIZINE DIHYDROCHLORIDE USP (1)

45 CINACALCET HYDROCHLORIDE (1)

46 CIPROFLOXACIN HYDROCHLORIDE USP (1)

47 CIPROFLOXACIN HYDROCHLORIDE USP IN BANGALORE, INDIA (1)

48 CITALOPRAM HYDROBROMIDE (1)

49 CITALOPRAM HYDROBROMIDE USP (2)

50 CLONIDINE HCL (1)

51 CLOPIDOGREL BISULPHATE (1)

52 CYPROTERONE ACETATE BP/PH.EUR. (1)

53 DACLATASVIR DIHYDROCHLORIDE (1)

54 DANAZOL USP (1)

55 DARIFENACIN HYDROBROMIDE (1)

56 DARUNAVIR (1)

57 DARUNAVIR ETHANOLATE (1)

58 DARUNAVIR HYDRATE (1)

59 DARUNAVIR HYDRATE (PROCESS II) (1)

60 DASATINIB (1)

61 DASATINIB (A) (1)

62 DASATINIB MONOHYDRATE (1)

63 DEFERASIROX (1)

64 DESLORATADINE (1)

65 DESLORATADINE FORM I: FORM II (89:11) (1)

66 DIDANOSINE USP (1)

67 DISODIUM PAMIDRONATE USP (1)

68 DOLUTEGRAVIR SODIUM (1)

69 DOLUTEGRAVIR SODIUM (FORM C) (1)

70 DOLUTEGRAVIR SODIUM PROCESS A (1)

71 DONEPEZIL HYDROCHLORIDE FORM-I (1)

72 DONEPEZIL HYDROCHLORIDE USP (ANHYDROUS) (1)

73 DOXAZOSIN MESYLATE (1)

74 DUTASTERIDE (1)

75 Difelikefalin Acetate (1)

76 EDARAVONE (1)

77 EFAVIRENZ USP (1)

78 EFINACONAZOLE (1)

79 ELIGLUSTAT HEMITARTRATE (1)

80 EMPAGLIFLOZIN (1)

81 EMTRICITABINE (1)

82 ENTECAVIR MONOHYDRATE USP (1)

83 ENZALUTAMIDE (1)

84 ERLOTINIB HYDROCHLORIDE (1)

85 ESCITALOPRAM OXALATE USP (1)

86 ESCITALOPRAM OXALATE USP (PROCESS-II) (1)

87 ESOMEPRAZOLE MAGNESIUM DIHYDRATE USP (1)

88 ESOMEPRAZOLE MAGNESIUM USP (1)

89 ETOPOSIDE USP (1)

90 EXEMESTANE USP (1)

91 FACILITIES, CONTROLS AND OPERATING PROC. AT BOMBAY, INDIA (1)

92 FACILITIES, CONTROLS, AND OPERATING PROC. AT BANGALORE, INDIA (1)

93 FACILITIES, CONTROLS, AND OPERATING PROC. AT VIKHROLI, INDIA (1)

94 FAMCICLOVIR USP (1)

95 FELODIPINE USP (1)

96 FEXOFENADINE HYDROCHLORIDE USP (1)

97 FINASTERIDE USP (2)

98 FLUCONAZOLE USP (2)

99 FLUTAMIDE USP (1)

100 FLUTICASONE FUROATE (1)

101 FLUTICASONE PROPIONATE USP (1)

102 FLUTICASONE PROPIONATE USP (PROCESS II) (1)

103 FLUTICASONE PROPIONATE USP (PROCESS III) (1)

104 FORMOTEROL FUMARATE USP (1)

105 GEFITINIB (1)

106 GEMCITABINE HYDROCHLORIDE USP (1)

107 GRANISETRON HYDROCHLORIDE USP (1)

108 GRANISETRON USP (1)

109 IBRUTINIB (1)

110 IBUPROFEN USP AS PROCESSED IN FACTORIES NO.2, NO. 3, NO.4 CITED IN D (1)

111 ICATIBANT ACETATE (1)

112 IMATINIB MESYLATE (A-FORM) (1)

113 IMATINIB MESYLATE (BETA FORM) (1)

114 IMIQUIMOD (1)

115 INDACATEROL ACETATE (1)

116 IPRATROPIUM BROMIDE USP (1)

117 IRBESARTAN (1)

118 IRINOTECAN HYDROCHLORIDE TRIHYDRATE USP (1)

119 ISAVUCONAZONIUM SULFATE (1)

120 LAMIVUDINE USP (1)

121 LAMIVUDINE USP (PROCESS 2) (1)

122 LAMIVUDINE USP (PROCESS 3) (1)

123 LAMOTRIGINE USP (1)

124 LANSOPRAZOLE USP (1)

125 LEFLUNOMIDE USP (1)

126 LENALIDOMIDE (1)

127 LENALIDOMIDE HEMIHYDRATE (1)

128 LETROZOLE USP (1)

129 LEVALBUTEROL HYDROCHLORIDE USP (1)

130 LEVO SALBUTAMOL SULPHATE (1)

131 LEVOCETIRIZINE DIHYDROCHLORIDE USP (1)

132 LEVOFLOXACIN HEMIHYDRATE USP (1)

133 LEVOFLOXACIN USP (1)

134 LEVONORGESTREL USP (1)

135 LOPINAVIR USP (1)

136 LORAZEPAM USP (1)

137 LOSARTAN POTASSIUM USP (1)

138 LUMEFANTRINE (1)

139 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN KURKUMBH, INDIA. (1)

140 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PATALGANGA, INDIA. (1)

141 MEBENDAZOLE USP (1)

142 MELOXICAM USP (1)

143 METAPROTERENOL SULFATE (1)

144 METHOCARBAMOL (1)

145 METOPROLOL TARTRATE (1)

146 MIRABEGRON (1)

147 MITOXANTRONE HYDROCHLORIDE (1)

148 MITOXANTRONE HYDROCHLORIDE USP (1)

149 MOMETASONE FUROATE MONOHYDRATE (2)

150 MOMETHASONE FUROATE USP (1)

151 MONTELUKAST SODIUM USP (1)

152 MOXIFLOXACIN HYDROCHLORIDE PH. EUR. (1)

153 MYCOPHENOLATE MOFETIL BP/PH. EUR. (1)

154 NATEGLINIDE USP (1)

155 NEVIRAPINE HEMIHYDRATE USP (1)

156 NEVIRAPINE USP (1)

157 NIFEDIPINE USP XXI (1)

158 NILOTINIB D-TARTRATE (1)

159 NINTEDANIB ESYLATE (1)

160 NIRMATRELVIR (1)

161 NORFLOXACIN (1)

162 NORFLOXACIN USP (1)

163 OFLOXACIN USP (1)

164 OLANZAPINE (1)

165 OLANZAPINE USP (1)

166 OLAPARIB (1)

167 OMEPRAZOLE SODIUM (1)

168 OMEPRAZOLE USP (1)

169 ONDANSETRON HCL USP (1)

170 OSELTAMIVIR PHOSPHATE USP (1)

171 OXALIPLATIN PH. EUR. (1)

172 PALIPERIDONE USP (1)

173 PALONOSETRON HYDROCHLORIDE USP (1)

174 PAMIDRONIC ACID (1)

175 PANTOPRAZOLE SODIUM USP (1)

176 PAZOPANIB HYDROCHLORIDE (1)

177 PERINDOPRIL ERBUMINE MONOHYDRATE (1)

178 PIOGLITAZONE HYDROCHLORIDE USP (1)

179 PIRFENIDONE (1)

180 PODOPHYLLOTOXIN (1)

181 POMALIDOMIDE (2)

182 PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP (1)

183 PRAZIQUANTEL USP (1)

184 PREGABALIN USP (1)

185 PROPANALOL HYDROCHLORIDE (1)

186 PROPANOLOL HCl (1)

187 QUETIAPINE FUMERATE (1)

188 RABEPRAZOLE SODIUM (1)

189 RALOXIFENE HYDROCHLORIDE (1)

190 RALOXIFENE HYDROCHLORIDE USP (1)

191 RAMIPRIL USP (1)

192 RANOLAZINE (1)

193 REVEFENACIN (1)

194 RILPIVIRINE (1)

195 RILPIVIRINE HYDROCHLORIDE (1)

196 RISEDRONATE SODIUM HEMI PENTAHYDRATE USP (1)

197 RISPERIDONE USP (1)

198 RITONAVIR USP (1)

199 RIVAROXABAN (1)

200 RIVASTIGMINE TARTRATE USP (1)

201 RIZATRIPTAN BENZOATE (1)

202 RIZATRIPTAN BENZOATE USP (1)

203 ROSIGLITAZONE MALEATE (1)

204 RUXOLITINIB PHOSPHATE (1)

205 SALMETEROL XINAFOATE (2)

206 SALMETEROL XINAFOATE USP (1)

207 SAXAGLIPTIN HYDROCHLORIDE (1)

208 SERTRALINE HYDROCHLORIDE (FORM II) (1)

209 SERTRALINE HYDROCHLORIDE (FORM-I) (1)

210 SERTRALINE HYDROCHLORIDE USP (FORM-V) (1)

211 SIBUTRAMINE HYDROCHLORIDE (1)

212 SIPONIMOD ADIPIC ACID (1)

213 SODIUM THIOSULFATE USP (1)

214 SOLIFENACIN SUCCINATE (1)

215 SORAFENIB TOSYLATE (FORM 1) (1)

216 SORAFENIB TOSYLATE 3 (1)

217 SORAFENIB TOSYLATE USP (1)

218 STAVUDINE USP (1)

219 SUMATRIPTAN SUCCINATE USP (1)

220 TAFAMIDIS (1)

221 TAFAMIDIS (I) (1)

222 TAMSULOSIN HYDROCHLORIDE (1)

223 TELMISARTAN USP (1)

224 TEMOZOLOMIDE USP (1)

225 TENOFOVIR ALAFENAMIDE FUMARATE (1)

226 TENOFOVIR ALAFENAMIDE FUMARATE (C) (1)

227 TENOFOVIR ALAFENAMIDE MONOFUMARATE (1)

228 TENOFOVIR DISOPROXIL FUMARATE (1)

229 TENOFOVIR DISOPROXIL FUMARATE (PROCESS B) (1)

230 TERBINAFINE HYDROCHLORIDE USP (1)

231 TERBUTALINE SULFATE USP (1)

232 TESTOSTERONE USP (1)

233 TOLTERODINE TARTRATE USP (1)

234 TOPIRAMATE USP (1)

235 TOPOTECAN HYDROCHLORIDE (1)

236 TORSEMIDE USP (1)

237 TRIMETAZIDINE DIHYDROCHLORIDE BP/PH.EUR. (1)

238 TRIOXSALEN, PROCEDS.FOR THE (1)

239 UMECLIDINIUM BROMIDE (1)

240 VALACYCLOVIR HYDROCHLORIDE DIHYDRATE USP (1)

241 VALGANCICLOVIR HYDROCHLORIDE USP (1)

242 VENLAFAXINE HYDROCHLORIDE FORM B (1)

243 VINBLASTINE SULFATE USP (1)

244 VINCRISTINE SULFATE USP (1)

245 VINORELBINE TARTRATE USP (1)

246 VORTIOXETINE HYDROBROMIDE (1)

247 ZALEPLON (1)

248 ZIDOVUDINE USP (1)

249 ZOLEDRONIC ACID (1)

250 ZOLPIDEM TARTRATE BP/PH.EUR. (1)

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