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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Dr. Reddy's Laboratories to the U.S. FDA. Original Data : FDA Website

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01 ABIRATERONE ACETATE (1)

02 AMLODIPINE BESILATE USP (1)

03 APALUTAMIDE (1)

04 APALUTAMIDE (AMORPHOUS) (1)

05 APIXABAN (1)

06 APREMILAST (FORM B) (1)

07 APREMILAST [AMORPHOUS] (1)

08 ATOMOXETINE HYDROCHLORIDE USP (1)

09 ATORVASTATIN CALCIUM (AMORPHOUS) (1)

10 ATORVASTATIN CALCIUM (BUTYLATED HYDROXY ANISOLE PREMIX) (1)

11 ATORVASTATIN CALCIUM (FORM P) USP, SEMICRYSTALLINE (1)

12 ATORVASTATIN CALCIUM (NO BHA PREMIX) (1)

13 ATORVASTATIN CALCIUM TRIHYDRATE (FORM I), USP (1)

14 ATORVASTATIN CALCIUM TRIHYDRATE [FORM-I] [ATN PROCESS] (1)

15 AZACITIDINE (1)

16 BEMPEDOIC ACID (1)

17 BENDAMUSTINE HYDROCHLORIDE USP (1)

18 BENZTROPINE MESYLATE USP (1)

19 BORTEZOMIB (1)

20 CABAZITAXEL (1)

21 CABOZANTINIB (S)-MALATE (FORM N-2) (1)

22 CABOZANTINIB HYDROCHLORIDE (1)

23 CABOZANTINIB INTERMEDIATE (CZT3) (1)

24 CANAGLIFLOZIN (1)

25 CAPECITABINE USP (1)

26 CARFILZOMIB (1)

27 CETIRIZINE DIHYDROCHLORIDE (1)

28 CINACALCET HYDROCHLORIDE (1)

29 CLOPIDOGREL BISULFATE FORM-II (1)

30 CLOPIDOGREL BISULFATE [FORM-I] USP (1)

31 DABIGATRAN ETEXILATE MESYLATE (1)

32 DAPAGLIFLOZIN (AMORPHOUS) (1)

33 DAPAGLIFLOZIN PROPANEDIOL (1)

34 DASATINIB (S)-PROPYLENE GLYCOL (1)

35 DASATINIB MONOHYDRATE (1)

36 DECITABINE (1)

37 DESLORATADINE USP (1)

38 DILUTED TACROLIMUS 20% (1)

39 DIMETHYL FUMARATE (1)

40 DL-NAPROXEN (1)

41 DONEPEZIL HYDROCHLORIDE MONOHYDRATE (FORM-1) USP (1)

42 DOXAZOSIN MESYLATE USP (1)

43 DUTASTERIDE (PROCESS-II) USP (1)

44 EDARAVONE (1)

45 ELAGOLIX SODIUM (1)

46 ELIGLUSTAT TARTRATE (1)

47 ENALAPRIL MALEATE, USP (1)

48 ENZALUTAMIDE (1)

49 ERIBULIN FRAGMENT-A (1)

50 ERIBULIN MESYLATE (1)

51 ESLICARBAZEPINE ACETATE (1)

52 ESOMEPRAZOLE MAGNESIUM AMORPHOUS (PROCESS-2) USP (1)

53 ESOMEPRAZOLE MAGNESIUM TRIHYDRATE USP (1)

54 ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, USP (1)

55 ESZOPICLONE USP (1)

56 FAMOTIDINE USP (1)

57 FEXOFENADINE HYDROCHLORIDE (1)

58 FEXOFENADINE HYDROCHLORIDE USP (FORM-I) (1)

59 FINASTERIDE USP (FORM III) (1)

60 FONDAPARINUX SODIUM USP (1)

61 FOSAPREPITANT DIMEGLUMINE (1)

62 GATIFLOXACIN ANHYDROUS (1)

63 GEMCITABINE HYDROCHLORIDE USP (1)

64 GLIMEPIRIDE USP (1)

65 GRANISETRON USP (1)

66 HYDROXYCHLOROQUINE SULFATE USP (1)

67 IBRUTINIB (1)

68 IBRUTINIB (FORM-A) (1)

69 IRON SUCROSE (1)

70 KETOROLAC TROMETHAMINE USP (1)

71 LENALIDOMIDE (1)

72 LENALIDOMIDE (POVIDONE PREMIX) (1)

73 LENALIDOMIDE DIMETHYLFORMAMIDE SOLVATE (1)

74 LENVATINIB MESYLATE (FORM-C) (1)

75 LENVATINIB MESYLATE (MIBK SOLVATE) (1)

76 LEVETIRACETAM (1)

77 LEVOCETIRIZINE DIHYDROCLORIDE USP (1)

78 LIFITEGRAST (1)

79 LINAGLIPTIN (1)

80 LIRAGLUTIDE (1)

81 LOMUSTINE USP (1)

82 LOSARTAN POTASSIUM (FORM-1) (1)

83 LOSARTAN POTASSIUM FORM-1 (1)

84 LUBIPROSTONE (1)

85 LUMATEPERONE TOSYLATE (1)

86 LURASIDONE HYDROCHLORIDE (1)

87 MEMANTINE HYDROCHLORIDE USP (1)

88 METOPROLOL SUCCINATE USP (1)

89 MIDOSTAURIN (1)

90 MIDOSTAURIN AMORPHOUS (1)

91 MIRABEGRON [FORM - AMORPHOUS] (1)

92 MIRABEGRON [PRODUCT CODE: AEB] (1)

93 MONTELUKAST SODIUM [PROCESS-2] (1)

94 MOXIFLOXACIN HYDROCHLORIDE USP (1)

95 NAPROXEN (2)

96 NAPROXEN SODIUM (2)

97 NARATRIPTAN HYDROCHLORIDE (1)

98 NILOTINIB HYDROCHLORIDE (1)

99 NILOTINIB HYDROCHLORIDE MONOHYDRATE (1)

100 NIZATIDINE USP (1)

101 OBETICHOLIC ACID (1)

102 OLANZAPINE (FORM 1) USP (1)

103 OLAPARIB (1)

104 OMEPRAZOLE (FORM B) USP (1)

105 OMEPRAZOLE MAGNESIUM (1)

106 OMEPRAZOLE MAGNESIUM (CRYSTALLINE) (1)

107 OMEPRAZOLE [PROCESS-II] (1)

108 OMEPRAZOLE, USP (1)

109 ONDANSETRON (1)

110 ONDANSETRON HYDROCHLORIDE DIHYDRATE USP (1)

111 OXAPROZIN USP (1)

112 PALBOCICLIB (1)

113 PALIPERIDONE PALMITATE (1)

114 PALIPERIDONE USP (1)

115 PALONOSETRON HYDROCHLORIDE USP (1)

116 PANTOPRAZOLE SODIUM USP (1)

117 PANTOPRAZOLE SODIUM USP [PROCESS-2] (1)

118 PAZOPANIB HYDROCHLORIDE (1)

119 PEMETREXED DISODIUM (AMORPHOUS) (1)

120 PEMETREXED DISODIUM USP (HEPTAHYDRATE) (1)

121 PEMETREXED DITROMETHAMINE DIHYDRATE (1)

122 PERMETHRIN BPC CIS:TRANS/25:75 (1)

123 PIOGLITAZONE HYDROCHLORIDE USP (1)

124 PLERIXAFOR (1)

125 POMALIDOMIDE (1)

126 POSACONAZOLE (1)

127 PRASUGREL HYDROCHLORIDE USP (1)

128 PREGABALIN USP (2)

129 PRIMIDONE (1)

130 QUETIAPINE FUMARATE USP (1)

131 RABEPRAZOLE SODIUM (FORM-Y) (1)

132 RABEPRAZOLE SODIUM HYDRATE (FORM Y) USP (1)

133 RALOXIFENE HYDROCHLORIDE USP (1)

134 RAMIPRIL USP (1)

135 RANITIDINE HYDROCHLORIDE (FORM I) (1)

136 RANITIDINE HYDROCHLORIDE [FORM-2] (1)

137 RANOLAZINE (1)

138 RASAGILINE MESYLATE (1)

139 REPAGLINIDE (1)

140 RISPERIDONE FORM-1 USP (1)

141 RITONAVIR USP (1)

142 RIVAROXABAN USP (1)

143 RIVASTIGMINE HYDROGEN TARTRATE (1)

144 RIVASTIGMINE HYDROGEN TARTRATE (PROCESS II ) (1)

145 RIZATRIPTAN BENZOATE USP (1)

146 ROPINIROLE HYDROCHLORIDE (1)

147 ROSIGLITAZONE MALEATE USP (FORM III) (1)

148 ROXADUSTAT (1)

149 ROXADUSTAT L-PROLINE (1)

150 SACUBITRIL/VALSARTAN (1)

151 SAXAGLIPTIN HYDROCHLORIDE (1)

152 SEMAGLUTIDE (1)

153 SERTRALINE HYDROCHLORIDE (FORM II) (1)

154 SIPONIMOD HEMIFUMARATE (1)

155 SITAGLIPTIN HYDROCHLORIDE (MONOHYDRATE) (1)

156 SITAGLIPTIN PHOSPHATE USP (ANHYDROUS) (1)

157 SITAGLIPTIN PHOSPHATE USP (MONOHYDRATE) (1)

158 SOLIFENACIN SUCCINATE (1)

159 SUGAMMADEX SODIUM (1)

160 SULINDAC USP (1)

161 SUMATRIPTAN SUCCINATE (1)

162 SUMATRIPTAN SUCCINATE USP (1)

163 TAFAMIDIS MEGLUMINE (1)

164 TELMISARTAN (PROCESS-II) USP (1)

165 TERBINAFINE HYDROCHLORIDE USP (1)

166 TESTOSTERONE (1)

167 TICAGRELOR (1)

168 TIZANIDINE HYDROCHLORIDE USP (1)

169 TOFACITINIB CITRATE (1)

170 TOLTERODINE TARTRATE (1)

171 TOPIRAMATE USP (1)

172 TRAVOPROST (1)

173 TREPROSTINIL (1)

174 UDENAFIL (1)

175 VALGANCICLOVIR HYDROCHLORIDE USP (AMORPHOUS) (1)

176 VALGANCICLOVIR HYDROCHLORIDE USP (CRYSTALLINE) (1)

177 VALSARTAN (1)

178 VARENICLINE TARTRATE (1)

179 VENETOCLAX (1)

180 VENLAFAXINE HYDROCHLORIDE USP (1)

181 VILAZODONE HYDROCHLORIDE (1)

182 VORICONAZOLE USP (1)

183 VORICONAZOLE, USP (PROCESS-II) (1)

184 ZAFIRLUKAST (AMORPHOUS) (1)

185 ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE (1)

186 ZIPRASIDONE HYDROCHLORIDE USP (1)

187 ZOLEDRONIC ACID MONOHYDRATE USP (1)

188 ZOLMITRIPTAN (PROCESS-II) (1)

189 ZOLPIDEM TARTRATE (1)

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01 DR REDDYS LABORATORIES LTD (192)

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01 India (192)

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01 Active (192)

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01 Complete (119)

02 Blank (73)

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