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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 116A-BROMOEPIANDROSTERONE

02 1ABACAVIR SULFATE USP

03 1ABIRATERONE ACETATE

04 1ABIRATERONE ACETATE USP

05 1ACALABRUTINIB

06 1ACALABRUTINIB MALEATE

07 1ACYCLOVIR

08 1ADEFOVIR DIPIVOXIL

09 1ALBENDAZOLE (B) USP

10 1ALBENDAZOLE USP

11 1ALBUTEROL

12 2ALBUTEROL SULFATE USP

13 1ALENDRONATE SODIUM USP

14 1ALFUZOSIN HYDROCHLORIDE

15 1ALOSETRON HYDROCHLORIDE USP

16 1ALPRAZOLAM USP

17 1AMBRISENTAN

18 1AMLODIPINE BESYLATE USP

19 1AMLODIPINE MESYLATE MONOHYDRATE

20 1ANAGRELIDE HYDROCHLORIDE MONOHYDRATE USP

21 1ANASTROZOLE USP

22 1APREMILAST

23 1ARFORMOTEROL TARTRATE

24 1ARIPIPRAZOLE

25 1ARTEMETHER

26 1ARTESUNATE

27 1ATAZANAVIR SULPHATE

28 1ATAZANAVIR SULPHATE (METHANOL ROUTE)

29 1AZELASTINE HYDROCHLORIDE BP/PH.EUR

30 1BECLOMETHASONE DIPROPIONATE

31 1BECLOMETHASONE DIPROPIONATE USP (ANHYDROUS)

32 1BICALUTAMIDE USP

33 1BICTEGRAVIR SODIUM

34 1BORTEZOMIB

35 1BOSENTAN MONOHYDRATE

36 1BREXPIPRAZOLE

37 1BUDESONIDE USP

38 1CABOTEGRAVIR

39 1CABOTEGRAVIR SODIUM

40 1CAPECITABINE USP

41 1CARBOPLATIN USP

42 1CARVEDILOL USP

43 1CELECOXIB USP

44 1CETIRIZINE DIHYDROCHLORIDE USP

45 1CINACALCET HYDROCHLORIDE

46 1CIPROFLOXACIN HYDROCHLORIDE USP

47 1CIPROFLOXACIN HYDROCHLORIDE USP IN BANGALORE, INDIA

48 1CITALOPRAM HYDROBROMIDE

49 2CITALOPRAM HYDROBROMIDE USP

50 1CLONIDINE HCL

51 1CLOPIDOGREL BISULPHATE

52 1CYPROTERONE ACETATE BP/PH.EUR.

53 1DACLATASVIR DIHYDROCHLORIDE

54 1DANAZOL USP

55 1DARIFENACIN HYDROBROMIDE

56 1DARUNAVIR

57 1DARUNAVIR ETHANOLATE

58 1DARUNAVIR HYDRATE

59 1DARUNAVIR HYDRATE (PROCESS II)

60 1DASATINIB

61 1DASATINIB (A)

62 1DASATINIB MONOHYDRATE

63 1DEFERASIROX

64 1DESLORATADINE

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

66 1DIDANOSINE USP

67 1DIFELIKEFALIN ACETATE

68 1DISODIUM PAMIDRONATE USP

69 1DOLUTEGRAVIR SODIUM

70 1DOLUTEGRAVIR SODIUM (FORM C)

71 1DOLUTEGRAVIR SODIUM PROCESS A

72 1DONEPEZIL HYDROCHLORIDE FORM-I

73 1DONEPEZIL HYDROCHLORIDE USP (ANHYDROUS)

74 1DOXAZOSIN MESYLATE

75 1DUTASTERIDE

76 1EDARAVONE

77 1EFAVIRENZ USP

78 1EFINACONAZOLE

79 1ELIGLUSTAT HEMITARTRATE

80 1EMPAGLIFLOZIN

81 1EMTRICITABINE

82 1ENTECAVIR MONOHYDRATE USP

83 1ENZALUTAMIDE

84 1ERLOTINIB HYDROCHLORIDE

85 1ESCITALOPRAM OXALATE USP

86 1ESCITALOPRAM OXALATE USP (PROCESS-II)

87 1ESOMEPRAZOLE MAGNESIUM DIHYDRATE USP

88 1ESOMEPRAZOLE MAGNESIUM USP

89 1ETOPOSIDE USP

90 1EXEMESTANE USP

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

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

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

94 1FAMCICLOVIR USP

95 1FELODIPINE USP

96 1FEXOFENADINE HYDROCHLORIDE USP

97 2FINASTERIDE USP

98 2FLUCONAZOLE USP

99 1FLUTAMIDE USP

100 1FLUTICASONE FUROATE

101 1FLUTICASONE PROPIONATE USP

102 1FLUTICASONE PROPIONATE USP (PROCESS II)

103 1FLUTICASONE PROPIONATE USP (PROCESS III)

104 1FORMOTEROL FUMARATE USP

105 1GEFITINIB

106 1GEMCITABINE HYDROCHLORIDE USP

107 1GRANISETRON HYDROCHLORIDE USP

108 1GRANISETRON USP

109 1IBRUTINIB

110 1IBUPROFEN USP AS PROCESSED IN FACTORIES NO.2, NO. 3, NO.4 CITED IN DMF

111 1ICATIBANT ACETATE

112 1IMATINIB MESYLATE (A-FORM)

113 1IMATINIB MESYLATE (BETA FORM)

114 1IMIQUIMOD

115 1INDACATEROL ACETATE

116 1IPRATROPIUM BROMIDE USP

117 1IRBESARTAN

118 1IRINOTECAN HYDROCHLORIDE TRIHYDRATE USP

119 1ISAVUCONAZONIUM SULFATE

120 1IVACAFTOR

121 1LAMIVUDINE USP

122 1LAMIVUDINE USP (PROCESS 2)

123 1LAMIVUDINE USP (PROCESS 3)

124 1LAMOTRIGINE USP

125 1LANSOPRAZOLE USP

126 1LEFLUNOMIDE USP

127 1LENALIDOMIDE

128 1LENALIDOMIDE HEMIHYDRATE

129 1LETROZOLE USP

130 1LEVALBUTEROL HYDROCHLORIDE USP

131 1LEVO SALBUTAMOL SULPHATE

132 1LEVOCETIRIZINE DIHYDROCHLORIDE USP

133 1LEVOFLOXACIN HEMIHYDRATE USP

134 1LEVOFLOXACIN USP

135 1LEVONORGESTREL USP

136 1LOPINAVIR USP

137 1LORAZEPAM USP

138 1LOSARTAN POTASSIUM USP

139 1LUMEFANTRINE

140 1MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN KURKUMBH, INDIA.

141 1MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PATALGANGA, INDIA.

142 1MEBENDAZOLE USP

143 1MELOXICAM USP

144 1METAPROTERENOL SULFATE

145 1METHOCARBAMOL

146 1METOPROLOL TARTRATE

147 1MIRABEGRON

148 1MITOXANTRONE HYDROCHLORIDE

149 1MITOXANTRONE HYDROCHLORIDE USP

150 2MOMETASONE FUROATE MONOHYDRATE

151 1MOMETHASONE FUROATE USP

152 1MONTELUKAST SODIUM USP

153 1MOXIFLOXACIN HYDROCHLORIDE PH. EUR.

154 1MYCOPHENOLATE MOFETIL BP/PH. EUR.

155 1NATEGLINIDE USP

156 1NEVIRAPINE HEMIHYDRATE USP

157 1NEVIRAPINE USP

158 1NIFEDIPINE USP XXI

159 1NILOTINIB D-TARTRATE

160 1NINTEDANIB ESYLATE

161 1NIRMATRELVIR

162 1NORFLOXACIN

163 1NORFLOXACIN USP

164 1OFLOXACIN USP

165 1OLANZAPINE

166 1OLANZAPINE USP

167 1OLAPARIB

168 1OMEPRAZOLE SODIUM

169 1OMEPRAZOLE USP

170 1ONDANSETRON HCL USP

171 1OSELTAMIVIR PHOSPHATE USP

172 1OXALIPLATIN PH. EUR.

173 1PALIPERIDONE USP

174 1PALONOSETRON HYDROCHLORIDE USP

175 1PAMIDRONIC ACID

176 1PANTOPRAZOLE SODIUM USP

177 1PAZOPANIB HYDROCHLORIDE

178 1PERINDOPRIL ERBUMINE MONOHYDRATE

179 1PIOGLITAZONE HYDROCHLORIDE USP

180 1PIRFENIDONE

181 1PODOPHYLLOTOXIN

182 2POMALIDOMIDE

183 1PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP

184 1PRAZIQUANTEL USP

185 1PREGABALIN USP

186 1PROPANALOL HYDROCHLORIDE

187 1PROPANOLOL HCl

188 1QUETIAPINE FUMERATE

189 1RABEPRAZOLE SODIUM

190 1RALOXIFENE HYDROCHLORIDE

191 1RALOXIFENE HYDROCHLORIDE USP

192 1RAMIPRIL USP

193 1RANOLAZINE

194 1RELUGOLIX

195 1REVEFENACIN

196 1RILPIVIRINE

197 1RILPIVIRINE HYDROCHLORIDE

198 1RISEDRONATE SODIUM HEMI PENTAHYDRATE USP

199 1RISPERIDONE USP

200 1RITONAVIR USP

201 1RIVAROXABAN

202 1RIVASTIGMINE TARTRATE USP

203 1RIZATRIPTAN BENZOATE

204 1RIZATRIPTAN BENZOATE USP

205 1ROSIGLITAZONE MALEATE

206 1RUXOLITINIB PHOSPHATE

207 2SALMETEROL XINAFOATE

208 1SALMETEROL XINAFOATE USP

209 1SAXAGLIPTIN HYDROCHLORIDE

210 1SERTRALINE HYDROCHLORIDE (FORM II)

211 1SERTRALINE HYDROCHLORIDE (FORM-I)

212 1SERTRALINE HYDROCHLORIDE USP (FORM-V)

213 1SIBUTRAMINE HYDROCHLORIDE

214 1SIPONIMOD ADIPIC ACID

215 1SODIUM THIOSULFATE USP

216 1SOLIFENACIN SUCCINATE

217 1SORAFENIB TOSYLATE (FORM 1)

218 1SORAFENIB TOSYLATE 3

219 1SORAFENIB TOSYLATE USP

220 1STAVUDINE USP

221 1SUMATRIPTAN SUCCINATE USP

222 1TAFAMIDIS

223 1TAFAMIDIS (I)

224 1TAMSULOSIN HYDROCHLORIDE

225 1TELMISARTAN USP

226 1TEMOZOLOMIDE USP

227 1TENOFOVIR ALAFENAMIDE FUMARATE

228 1TENOFOVIR ALAFENAMIDE FUMARATE (C)

229 1TENOFOVIR ALAFENAMIDE MONOFUMARATE

230 1TENOFOVIR DISOPROXIL FUMARATE

231 1TENOFOVIR DISOPROXIL FUMARATE (PROCESS B)

232 1TERBINAFINE HYDROCHLORIDE USP

233 1TERBUTALINE SULFATE USP

234 1TESTOSTERONE USP

235 1TOLTERODINE TARTRATE USP

236 1TOPIRAMATE USP

237 1TOPOTECAN HYDROCHLORIDE

238 1TORSEMIDE USP

239 1TRIMETAZIDINE DIHYDROCHLORIDE BP/PH.EUR.

240 1TRIOXSALEN, PROCEDS.FOR THE

241 1UMECLIDINIUM BROMIDE

242 1VALACYCLOVIR HYDROCHLORIDE DIHYDRATE USP

243 1VALGANCICLOVIR HYDROCHLORIDE USP

244 1VENLAFAXINE HYDROCHLORIDE FORM B

245 1VILANTEROL TRIFENATATE

246 1VINBLASTINE SULFATE USP

247 1VINCRISTINE SULFATE USP

248 1VINORELBINE TARTRATE USP

249 1VORTIOXETINE HYDROBROMIDE

250 1ZALEPLON

251 1ZIDOVUDINE USP

252 1ZOLEDRONIC ACID

253 1ZOLPIDEM TARTRATE BP/PH.EUR.

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