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

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01 2 BROMOACETAMIDO-5 CHLORO-2' FLUOROBENZOPHENONE (1)

02 6-ALPHA METHYLPREDNISOLONE (1)

03 6-AMINOPENICILLANIC ACID (1)

04 ABIRATERONE ACETATE USP (1)

05 ABIRATERONE ACETATE USP (NP) (1)

06 ACEBUTOLOL HYDROCHLORIDE (1)

07 ACETYL OXIDE (OXAZEPAM INTERMEDIATE) (1)

08 ACYCLOVIR (1)

09 ALISKIREN HEMIFUMARATE (1)

10 AMITRIPTYLINE HCL (1)

11 AMITRYPTILINE HCL (1)

12 AMOXICILLIN TRIHYDRATE (1)

13 APREMILAST (1)

14 APREMILAST (PROCESS II) (1)

15 ARIPIPRAZOLE (1)

16 ASENAPINE MALEATE (1)

17 ASTEMIZOLE (1)

18 AZITHROMYCIN HYDROGENCITRATE (1)

19 BECLOMETHASONE DIPROPIONATE USP (1)

20 BELLAFOLINE SUBSTANCE 60% (1)

21 BENAZEPRIL HYDROCHLORIDE (1)

22 BENZBROMARONE BULK (1)

23 BENZNIDAZOLE (1)

24 BENZNIDAZOLE (CODE 50954) (1)

25 BETAMETHASONE ACETATE (1)

26 BETAMETHASONE BASE USP XX (1)

27 BETAMETHASONE DIPROPIONATE (1)

28 BETAMETHASONE SODIUM PHOSPHATE (1)

29 BETAMETHASONE VALERATE USP XX (1)

30 BIMATOPROST (1)

31 BRINZOLAMIDE, USP (1)

32 BUDESONIDE (1)

33 BUDESONIDE USP (1)

34 BUMETANIDE (2)

35 BUSPIRONE (1)

36 BUSPIRONE HYDROCHLORIDE (1)

37 BUTOCONAZOLE NITRATE (1)

38 CAPTOPRIL (1)

39 CARIPRAZINE HYDROCHLORIDE (1)

40 CHLORAMPHENICOL (1)

41 CHLORAMPHENICOL PALMITATE (1)

42 CHLOROTHIAZIDE (BULK) - HYDROCHLOROTHIAZIDE (1)

43 CHLORTHALIDONE (1)

44 CIMETIDINE USP XXII (1)

45 CINOXACIN USP XXII (1)

46 CIPROFLOXACIN (1)

47 CIPROFLOXACIN HYDROCHLORIDE (2)

48 CLOFIBRATE USP (1)

49 CLORAZEPATE DIPOTASSIUM, BULK FORM (1)

50 DALFAMPRIDINE (1)

51 DESOGESTREL (1)

52 DESOGESTREL CN (1)

53 DEXAMETHASONE BASE, USP XX (1)

54 DEXBROMPHENIRAMINE MALEATE USP. XX (1)

55 DEXCHLORPHENIRAMINE MALEATE (1)

56 DEXTRO-PROPOXYPHENE HCL (1)

57 DIENOGEST (1)

58 DILTIAZEM HCL (1)

59 DIPHENHYDRAMINE HCL & DIMENHYDRINATE (1)

60 DIPYRIDAMOLE (1)

61 DISOPYRAMIDE PHOSPHATE AND DISOPYRAMIDE BASE (1)

62 DOFETILIDE USP (1)

63 DROPERIDOL (1)

64 DROSPIRENONE USP (1)

65 DROXIDOPA (1)

66 ECONAZOLE NITRATE (1)

67 EDARAVONE (1)

68 ELTROMBOPAG OLAMINE (1)

69 ENALAPRIL MALEATE (2)

70 EPLERENONE (1)

71 EPLERENONE PH. EUR. (1)

72 ETHINYLESTRADIOL USP (1)

73 ETODOLAC (1)

74 ETONOGESTREL (1)

75 FACIL, PERSONNEL AND GENL OPERATING PROCEDURES AT MADRID,SPAIN (1)

76 FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN VARESE,ITALY (1)

77 FAMOTIDINE (2)

78 FINGOLIMOD HYDROCHLORIDE (CODE 50996) (1)

79 FLECAINIDE ACETATE PROCESS I (CODE 50064) (1)

80 FLECAINIDE ACETATE PROCESS II (CODE 50856) (1)

81 FLECAINIDE ACETATE PROCESS III (CODE 50970) (1)

82 FLUCONAZOLE (1)

83 FLUOXETINE HYDROCHLORIDE (2)

84 FLUTICASONE PROPIONATE USP (1)

85 FORMOTEROL FUMARATE DIHYDRATE MICRONIZED (1)

86 FORMOTEROL FUMARATE DIHYDRATE USP (1)

87 FOSFOMYCIN TROMETHAMINE (1)

88 FOSINOPRIL SODIUM (1)

89 FULVESTRANT USP (1)

90 GUANFACINE HYDROCHLORIDE (1)

91 HYDROCORTISONE HEMISUCCINATE (1)

92 IBUPROFEN (1)

93 IBUPROFEN USP (1)

94 IDEBENONE (1)

95 INDAPAMIDE (2)

96 INDOMETHACIN (1)

97 IRBESARTAN (1)

98 ISOSORBIDE DINITRATE (1)

99 ISRADIPINE (1)

100 ITRACONAZOLE (2)

101 IVERMECTIN PH. FUR. (1)

102 KETOCONAZOLE (3)

103 KETOROLAC TROMETHAMINE (2)

104 KETOTIFEN FUMERATE (1)

105 LANSOPRAZOLE (PROCESS II) (1)

106 LANSOPRAZOLE USP (1)

107 LANZOPRAZOLE (1)

108 LATANOPROST (1)

109 LEFLUNOMIDE (1)

110 LEVOFLOXACIN (3)

111 LEVOMILNACIPRAN HYDROCHLORIDE (1)

112 LEVONORGESTREL USP (1)

113 LOPERAMIDE HCL (1)

114 LORATADINE (2)

115 LOSARTAN POTASSIUM (1)

116 LOTEPREDNOL ETABONATE (1)

117 MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN SARONNO, ITALY (1)

118 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN EUGENIO GARZON, BUENOS AIRES. (1)

119 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MORGUIONDO 2011, ARGENTINA (1)

120 MANUFACTURING SITE, PERSONNEL, FACILITIES, AND GENERAL OPERATING PROCEDURES AT MILANO, ITALY. (1)

121 MECLIZINE HCL (1)

122 MECLOFENAMATE SODIUM USP (1)

123 MEDROXY PROGESTERONE ACETATE (1)

124 MEFENAMIC ACID (1)

125 MELOXICAM (1)

126 MEMANTINE HYDROCHLORIDE USP (1)

127 METAPROTERENOL SULPHATE USP (1)

128 MICONAZOLE NITRATE (1)

129 MIDODRINE HYDROCHLORIDE (1)

130 MOMETASONE FUROATE (1)

131 NICARDIPINE HYDROCHLORIDE (1)

132 NINTEDANIB ESYLATE (1)

133 NITAZOXANIDE (2)

134 NORFLOXACIN USP XXII (1)

135 NORGESTIMATE USP (1)

136 NORGESTIMATE USP (NP) (1)

137 Nedocromil Disodium (1)

138 OBETICHOLIC ACID (1)

139 OFLOXACIN (1)

140 OMEPRAZOLE (1)

141 OXPRENOLOL HcL (1)

142 OZANIMOD HYDROCHLORIDE (1)

143 PANTOPRAZOLE SODIUM (1)

144 PENTAZOCINE HYDROCHLORIDE (1)

145 PERAMPANEL (1)

146 PERSONNEL, FACILITIES AND CONTROLS(GENERAL OPERATING PROCEDURES) (1)

147 PHENTOLAMINE MESILATE USP (1)

148 PINDOLOL (1)

149 PIRFENIDONE (1)

150 POSACONAZOLE (1)

151 PREDNISOLONE SODIUM PHOSPHATE, USP XX (1)

152 PROCHLORPERAZINE MALEATE (1)

153 PROGESTERONE USP (1)

154 PROPRANOLOL HCL (1)

155 PROPRANOLOL HCL. (1)

156 QUINIDINE BASE/SULPHATE/GLUCONATE AND POLIGALACTURONATE (1)

157 RABEPRAZOLE SODIUM (PROCESS I) (1)

158 RABEPRAZOLE SODIUM (PROCESS II) (1)

159 RANITIDINE HCL FORM 1 (1)

160 RANITIDINE HYDROCHLORIDE (2)

161 RANOLAZINE (1)

162 RASAGILINE MESYLATE (CODE 50855) (1)

163 SEVELAMER CARBONATE (2)

164 SEVELAMER HYDROCHLORIDE (1)

165 SULFAMETHOXAZOLE (1)

166 SUMATRIPTAN (1)

167 SUMATRIPTAN SUCCINATE (1)

168 TAMSULOSIN HYDROCHLORIDE (2)

169 TERBINAFINE HYDROCHLORIDE (1)

170 TERBUTALINE SULFATE (1)

171 TERCONAZOLE (1)

172 TERFENADINE (3)

173 TERIFLUNOMIDE (1)

174 THIOTHIXENE BASE AND HC1 (1)

175 TIANEPTINE SODIUM (1)

176 TIOTROPIUM BROMIDE (1)

177 TRIAMCINOLONE ACETONIDE USPXX (1)

178 TRIMETHOBENZAMIDE HCL USP (1)

179 ULIPRISTAL ACETATE (1)

180 ZOLEDRONIC ACID MONOHYDRATE (CODE 50787) (1)

181 ZOLPIDEM TARTRATE (1)

182 ZOPICLONE (1)

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01 CHEMO IBERICA SA (6)

02 CHEMO IBERICA SA MADRID (3)

03 CHEMO SMS ENTERPRISE SL (2)

04 COMPANIA ESPANOLA DE SINTESIS QUIMICA SA (12)

05 INDUSTRIA CHEMICA PRODOTTI FRANCIS SPA (7)

06 INDUSTRIA CHIMICA MILANESE SPA (7)

07 INDUSTRIA CHIMICA PROFARMACO SPA (4)

08 INDUSTRIALE CHIMICA SRL (43)

09 INDUSTRIAS QUIMICAS ESTEVE SA (2)

10 INDUSTRIAS QUIMICAS TAUBATE SA (1)

11 INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPA (17)

12 INDUSTRIE CHIMICHE ITALIANE SPA (1)

13 MAPRIMED SA (23)

14 QUIMICA FINA FARMEX SA DE CV (2)

15 QUIMICA SINTETICA SA (69)

16 SINTESIS QUIMICA (1)

17 SINTESIS QUIMICA SA (1)

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01 Argentina (23)

02 Italy (82)

03 Spain (96)

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01 Active (90)

02 Inactive (111)

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01 Complete (64)

02 Blank (137)

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INDUSTRIA CHIMICA PRO...
Inactive
4696
N/A
1982-10-18
II
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COMPANIA ESPANOLA DE ...
Inactive
6725
N/A
1986-12-15
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SINTESIS QUIMICA SA
Inactive
11167
N/A
1994-10-26
II
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INDUSTRIALE CHIMICA S...
Active
28701
Complete
2015-01-05
2014-10-14
2014-10-08
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INDUSTRIALE CHIMICA S...
Active
34320
Complete
2020-02-19
2019-12-06
2019-12-12
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QUIMICA SINTETICA SA
Inactive
8874
N/A
1990-12-04
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INDUSTRIA CHIMICA PRO...
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5268
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1983-10-20
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QUIMICA SINTETICA SA
Active
8584
Complete
2014-02-07
2014-01-29
1990-05-25
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CHEMO IBERICA SA
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26776
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2012-12-27
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INDUSTRIA CHEMICA PRO...
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3449
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1979-02-26
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