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

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01 17 ALPHA-ESTRADIOL (1)

02 2,2'-(ETHYLENEDIIMINO) DIBUTYRIC ACID (1)

03 2-DEOXY-D-GLUCOSE (1)

04 2-DEOXYCYTIDINE (1)

05 5-BROMO-2'-DEOXYURIDINE (1)

06 6-AMINONICOTINAMIDE (1)

07 6-MERCAPTOPURINE HYDRATE AS OBTAINED FROM PHARMA-WALDHOF GmbH (1)

08 A-KETOISOCAPROIC ACID, SODIUM SALT (1)

09 ACETOHYDROXAMIC ACID (1)

10 ACETYL-BETA-METHYLCHOLINE CHLORIDE (1)

11 ACETYLCHOLINE CHLORIDE (1)

12 ADENINE - PRODUCT NO. 8626 FD (1)

13 ADENOSINE 5' TRIPHOSPHATE (ATP) DISODIUM SALT (1)

14 ADENOSINE, SIGMA GRADE (1)

15 ADENYLOSUCCINIC ACID (1)

16 ALPHA-LINOLENIC ACID (1)

17 AMETHOPTERIN (METHOTREXATE) (1)

18 AMINO ACIDS & THEIR SODIUM SALT DERIVATIVES RELATIVE TO HFN-130 INDs (1)

19 AMINO ACIDS: L-ARGININE, FREE BASE AND L-ARGININE, HYDROCHLORIDE (1)

20 AMINOOXY ACETIC ACID (1)

21 ANGIOTENSIN I (1)

22 ANTHRAX ANIMAL MODEL LOCATED IN BETHESDA, MARYLAND (1)

23 ANTI-FUNGAL DRUGS (1)

24 ANTIPYRINE AS PRODUCED IN THE ST. LOUIS, MISSOURI PLANT (1)

25 APOMORPHINE HCl (1)

26 APROTININ, BOVINE LUNG (1)

27 ARECOLINE HYDROBROMIDE (1)

28 ATROPINE METHYL NITRATE AS SUPPLIED BY MAC FARALAN SMITH, LIMITED (1)

29 B-MERCAPTOCTHYLAMINE HYDROCHLORIDE (CYSTEAMINE) (1)

30 B-NICOTINAMIDE ADENINE DINUCLEOTIDE (1)

31 BACITRACIN ZINC (1)

32 BETA-AMINOPROPIONITRILE MONOFUMARARTE SALT (1)

33 BETA-ESTRADIOL (1)

34 BETA-ESTRADIOL-3-BENZOATE (1)

35 BETA-GLYCEROPHOSPHATE GRADE XII CALCIUM SALT (1)

36 BETA-PHENYLETHYLAMINE HYDROCHLORIDE (1)

37 BETAINE FREE BASE ANHYDROUS PURCHASED BY SIGMA LTD LONDON FOR USA (1)

38 BIOACTIVE PEPTIDES (FORMERLY SOMATOSTATIN) (1)

39 BRADYKININ ACETATE SALT (1)

40 CATABATE, SODIUM OXYBATE, GAMMA-HYDROXYBUTYRIC ACID, SODIUM SALT (1)

41 CATALASE (1)

42 CHOLESTEROL (1)

43 CHOLIC ACID SODIUM SALT (1)

44 CHOLINE CHLORIDE (1)

45 COLLAGEN (PRODUCT NO. C 9301) (1)

46 CORTICOSTERONE (1)

47 COUMARIN (1)

48 CYCLOHEXIMIDE (1)

49 D (+) GALACTOSE PRODUCT NO. G 0750 FD (1)

50 D (-) PENICILLAMINE (1)

51 D (-)-RIBOSE PRODUCT # R 7500 FD (1)

52 D-AMPHETAMINE SULFATE # A5880 FD & (+) METHAMPHETAMINE HCL NO. M8750FD (1)

53 D-ARGININE HYDROCHLORIDE (1)

54 D-GLUCONIC ACID HEMI CALCIUM SALT (1)

55 D-PANTETHINE (1)

56 D-PHENYLALANINE (1)

57 DEHYDROISOANDROSTERONE-3-SULFATE,SODIUM SALT (1)

58 DEHYROISOANDROSTERONE (1)

59 DELTA-AMINOLEVULINIC ACID HCL (1)

60 DEOXYCHOLIC ACID,SODIUM SALT (1)

61 DEOXYRIBONUCLEASE I (PROD. NO. D 5025) (1)

62 DEUTERIUM OXIDE (1)

63 DEXTROMETHORPHAN HYDROBROMIDE (1)

64 DIAMINE OXIDASE (1)

65 DIETHYLENETRIAMINE PENTACETIC ACID TRISODIUM ZINC SALT, 0.5 MOLAR SOL. (1)

66 DIETHYLENETRIAMINEPENTAACETIC ACID (CLINICAL STUDY BY D.HONEYCHURCH) (1)

67 DIMETHYL SULFOXIDE (1)

68 DIPYRIDAMOLE: SPECIFICATIONS AND RELABELLING (1)

69 DL-3,4- DIHYDROXYPHENYLGLYCOL #D9753FD (1)

70 DL-5-FLUOROTRYPTOPHAN (1)

71 DL-6,8-THIOTIC ACID, OXIDIZED FORM CLINICAL STUDIES BY DR. R. JACOBSON (1)

72 DL-6-METHYL-5,6,7,8-TETRAHYDROPTERINE (1)

73 DL-BETA-HYDROXYBUTYRIC ACID, SODIUM SALT (1)

74 DL-CARNITINE (1)

75 DL-PHENYLALANINE (1)

76 DL-THERO-3,4-DIHYDROXYPHENYLSERINE (1)

77 ESERINE SALICYLATE SALT (1)

78 ETHANOL SOLUTION OF CARDIOLIPIN SODIUM SALT (SIGMA CHEMICAL COMPANY) (1)

79 ETIOCHOLAAN-3 ALPHA-OL-17-ONE (1)

80 FRUCTOSE 1,6-DIPHOSPHATE (1)

81 FUSARIC ACID (1)

82 GLUCOSIDASE (1)

83 GLUTATHIONE OXIDIZED (1)

84 GLUTATHIONE, FREE ACID REDUCED FORM (1)

85 GLYCINE (1)

86 HEPES, FREE ACID AND HEPES, SODIUM SALT (1)

87 HEPES, SODIUM SALT (N-2-HYDROXYETHYLPIPERAZINE-N'-2-ETHANESULFONIC ACID) (1)

88 HISTOPAQUE (1077 & 1119) & PHYSIOLOGICAL SALTS MIXTURES PROC ST. LOUIS (1)

89 HYALURONIDASE. (1)

90 HYDRAZINE SULFATE (FAIRMOUNT CHEMICAL) (1)

91 INDOMETHACIN (1)

92 INOSINE (1)

93 INSULIN FROM BOVINE PANCREAS (1)

94 ISONICOTINIC ACID HYDRAZIDE (1)

95 L-ALANINE (1)

96 L-ALPHA-PHOSPHATIDYL CHOLINE TYPE II-S (1)

97 L-ALPHA-PHOSPHATIDYLCHOLINE TYPE XIII-E MDG. IN MISSOURI (1)

98 L-AMINO-n-BUTYRIC ACID (1)

99 L-ARGININE HYDROCHLORIDE (1)

100 L-ASPARTIC ACID (1)

101 L-B-3,4-DIHYDROXYPHENYLALANINE (L-DOPA) AND METHYL ESTER HCL. (1)

102 L-CARNITINE HCl (FIRST RUN) (1)

103 L-CYSTEINE (1)

104 L-GLUTAMIC ACID (1)

105 L-ISOLEUCINE (1)

106 L-LEUCINE (1)

107 L-LYSINE MONO HCl (1)

108 L-ORNITHINE HCL (1)

109 L-PHENYLALANINE (1)

110 L-PROLINE (1)

111 L-SERINE - (S 4500 FD (1)

112 L-THREONINE (1)

113 L-TRYPTOPHAN (1)

114 L-TYROSINE (1)

115 L-VALINE (1)

116 MELATONIN (1)

117 MESO-2,3-DIMERCAPTOSUCCINIC ACID (1)

118 METHIONINE ENKEPHALIN-ACETATE SALT (1)

119 METHYL COBALAMINE (1)

120 METHYLENE DIPHOSPHORIC ACID (1)

121 MUSCIMOL (1)

122 MYO-INOSITOL (1)

123 N,N-DIMETHYLTRYPTAMINE (1)

124 N-(2-MERCAPTOPROPIONYL) GLYCINE (1)

125 N-DODECYL B-D-MALTOSIDE, PRODUCT NO. D 4641 IN ST.LOUIS, MO. (1)

126 N-HYDROXYSUCCINIMIDOBIOTIN - PRODUCT NO. H 1759 FD (1)

127 NALOXONE HCL.AS RELABELLED FOR SIGMA (1)

128 NICOTINE #3876 FD (1)

129 O-PHTHALDIALDEHYDE (1)

130 OLEIC ACID SODIUM 95% (1)

131 OROTIC ACID (1)

132 OROTIC ACID ANHYDROUS (1)

133 PHENOLPHTHALEIN GLUCURONIC ACID (1)

134 PHENYLACETIC ACID (1)

135 POLY (ALA,GLU,LYS-HBR,TYR) 6:2:5:1 (1)

136 POLYETHYLENE GLYCOL (1)

137 PROGESTERONE (1)

138 PYRIDOXAL 5-PHOSPHATE (1)

139 PYRIDOXAL HYDROCHLORIDE (1)

140 PYRUVIC ACID SODIUM SALT (1)

141 QUINACRINE HCL. (1)

142 SELENO-DL-METHIONINE AS SUPPLIED BY SIGMA (ISRAEL)CHEMICAL COMPANY (1)

143 SODIUM PARA-AMINOBENZOATE (1)

144 SOMATOSTATIN (PRODUCT NO. S 9129 FD) (1)

145 STEARYLAMINE AS PROCESSED BY ARMAK FOR SIGMA F & D (1)

146 STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN ROCKAWAY, NJ (1)

147 STERILE PROCESSING DETAILS OF PHASE - 18 (1)

148 SUCCINIC ACID,DISODIUM HEXAHYDRATE (1)

149 TAURINE (1)

150 TES(N-tris[ HYRDOXYMETHYL ] methy 2-aminoethanesulfonic acid) (1)

151 TESTOSTERONE (1)

152 TETRAETHYLAMMONIUM CHLORIDE (1)

153 THIOPROLINE (1)

154 THYMIDINE (1)

155 TOXICITY REPORTS FOR KOLLICOATS RS 30 D PROCESSS FACILITY (1)

156 TRIMETHOPRIM (1)

157 TRIOLEIN (1)

158 TRIZMA BASE AS PROCESSED IN THE SAINT LOUIS, MISSOURI FACILITIES (1)

159 TRIZMA HYDROCHLORIDE (1)

160 TRYPSIN INHIBITOR,-T AND ALPHA-CHYMOTRYPS (1)

161 TRYPSIN TYPE III, BOVINE (1)

162 TYRAMINE HYDROCHLORIDE (1)

163 URIDINE (1)

164 YOHIMBINE HYDROCHLORIDE (1)

165 d-BIOTIN (1)

166 l ETHYL-3-(3-DIMETHYLAMINOPROPYL) CARBODIIMIDE HCl ST. LOUIS,MO PLANT (1)

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01 SIGMA F AND D DIV LTD (163)

02 SIGMA FOOD AND DRUG DIV SIGMA ALDRIDGE CORP (3)

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01 U.S.A (166)

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01 Inactive (166)

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01 Blank (166)

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SIGMA F AND D DIV LTD
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1978-05-05
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SIGMA F AND D DIV LTD
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1975-01-03
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SIGMA F AND D DIV LTD
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10442
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1993-08-17
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SIGMA F AND D DIV LTD
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4324
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1981-10-01
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SIGMA F AND D DIV LTD
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3714
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1980-01-30
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SIGMA F AND D DIV LTD
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1983-10-07
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SIGMA F AND D DIV LTD
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7771
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1988-11-08
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SIGMA F AND D DIV LTD
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1980-09-12
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2868
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1977-02-24
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SIGMA F AND D DIV LTD
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1987-10-13
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