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

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01 17a-HYDROXYPROGESTERONE, BULK (1)

02 17a-hydroxyprogesterone caproate usp, bulk, non-sterile,non-micronized (1)

03 6-ALPHA-METHYLPREDNISOLONE-21-HYDROGEN SUCCINATE (1)

04 6-AMINO PENICILLANIC ACID (1)

05 6-AMINOPENICILLANIC ACID (6-APA) (1)

06 7-ADCA (7-AMINO-3-DESACETOXY CEPHALOSPORANIC ACID) (1)

07 7-AMINO-3-CHLORO CEPHEM ESTER (1)

08 7-AMINO-DEACETOXY-CEPHALOSPORANIC ACID (7ADCA) (1)

09 7-ZACA- 7-AMINO-3-[2-(5-METBYL-1,3,4-TBIAZOLYDIL)-THIOMETHYL]-3-CEPHEM-4 CARBOXYLIC) ACID (1)

10 ACID CEFAZOLIN (INTERMEDIATE GRADE) (1)

11 ACID CEFOTETAN (1)

12 AMIKACIN 1.8 SULPHATE (1)

13 AMIKACIN BASE (1)

14 AMIKACIN SULFATE (1)

15 AMOXICILLIN (1)

16 AMPA (1)

17 AMPICILLIN AND SULBACTAM (STERILE BULK) (1)

18 AMPICILLIN SODIUM (STERILE BULK) (1)

19 AMPICILLIN TRIHYDRATE (1)

20 ARGININE (STERILE BULK) (1)

21 ARGININE USP, STERILE BULK (1)

22 ARGININE USP, STERILE BULK MPM180AF3 (1)

23 BECLOMETHASONE 17, 21- DIPROPIONATE (1)

24 BETAMETHASONE 17-VALERATE, NF BULK, NON STERILE, NON MICRON & MICRON (1)

25 BETAMETHASONE SODIUM PHOSPHATE, N.F. XIII BULK (1)

26 BOMBASIN (1)

27 CABERGOLINE ACTIVE DRUG SUBSTANCE (1)

28 CABERGOLINE FINISHED DOSAGE (1)

29 CEFACLOR MONOHYDRATE (1)

30 CEFADROXIL (1)

31 CEFADROXIL MONOHYDRATE (1)

32 CEFAMANDOLE NAFATE (1)

33 CEFAZOLIN FOR INJECTION 100G & 300G PHARMACY BULK PACKS (1)

34 CEFAZOLIN SODIUM (1)

35 CEFAZOLIN SODIUM LYOPHILIZED (STERILE, BULK) (1)

36 CEFEPIME FOR INJECTION (STERILE BULK) (1)

37 CEFEPIME FOR INJECTION USP (STERILE BULK) (1)

38 CEFEPIME HYDROCHLORIDE ORAL GRADE (1)

39 CEFOTAXIME ACID (1)

40 CEFOTAXIME SODIUM STERILE (1)

41 CEFOTETAN DISODIUM (STERILE BULK) (1)

42 CEFOXITIN ACID (1)

43 CEFOXITIN SODIUM (STERILE BULK) (1)

44 CEFOXITIN SODIUM STERILE BULK (1)

45 CEFOXITIN SODIUM USP STERILE 100 GRAMS (1)

46 CEFPROZIL (1)

47 CEFTAROLINE FOSAMIL STERILE DRUG SUBSTANCE (1)

48 CEFTAZIDIME DIHYDROCHLORIDE (1)

49 CEFTAZIDIME FOR INJECTION (STERILE BULK) (1)

50 CEFTAZIDIME FOR INJECTION USP (STERILE BULK) (1)

51 CEFTRIAXONE SODIUM NON STERILE USP (1)

52 CEFTRIAXONE SODIUM USP (STERILE BULK) (1)

53 CEFTRIAXONE SODIUM USP STERILE 100 GRAMS (1)

54 CEFTRIAXONE SODIUM, USP (STERILE BULK) (1)

55 CEFUROXIME ACID (1)

56 CEFUROXIME FOR INJECTION (75G AND 225G BULK PACKS) (1)

57 CEFUROXIME SODIUM (STERILE BULK) (1)

58 CEPHALEXIN MONOHYDRATE (2)

59 CEPHALOTHIN SODIUM (1)

60 CEPHALOTHIN SODIUM, ORAL GRADE (1)

61 CEPHALOTHIN SODIUM;SODIUM CHLORIDE (2)

62 CEPHAPIRIN ACID (1)

63 CEPHAPIRIN SODIUM (1)

64 CEPHRADINE MONOHYDRATE (1)

65 CHEM. & PHARMACY OF ANTIBIOTIC LM 427 AS IT WILL BE REFERENCED BY INDS (1)

66 CILASTATIN SODIUM (STERILE BULK) (1)

67 CLINDAMYCIN HYDROCHLORIDE (1)

68 CLINDAMYCIN PHOSPHATE (1)

69 CLOXACILLIN SODIUM (1)

70 CRUDE CEFEPIME HYDROCHLORIDE (1)

71 DEFU (DECARBAMOYLCEFUROXINE) (1)

72 DESONIDE, BULK, NON-STERILE, NON-MICRONIZED & MICRONIZED (1)

73 DEXAMETHASONE 21-SODIUM M-SULFOBENZOATE (1)

74 DEXAMETHASONE SODIUM PHOSPHATE BULK (1)

75 DEXAMETHASONE, NON-STERILE (BULK) (1)

76 ENDRYSONE (BULK, NON-STERILE, NON-MICRONIZED & MICRONIZED) (1)

77 ERTAPENEM SODIUM (1)

78 FACILITIES AND CONTROLS (1)

79 FACILITY AND OPERATING PROCEDURES IN VIA MARZABOTTO, VIMERCATE, MILANO, ITALY (PREVIOUSLY AN ANTIBIOTIC FILE) (1)

80 FLUMETHASONE 21-PIVALATE, MICRONIZED AND NON-MICRONIZED (1)

81 FLUMETHASONE, MICRONIZED AND NONMICRONIZED (1)

82 FLUOCINOLONE ACETONIDE (1)

83 FLUOCINONIDE (BULK, NON STERILE, NON-MICRONIZED & MICRONIZED) (1)

84 FLUOROMETHOLONE 17-ACETATE NON-MICRONIZED AND MICRONIZED (1)

85 FLURANDRENOLIDE USP BULK FORM (NON-STERILE) (1)

86 FLUROMETHOLONE-(BULK, NON-MICRONZIED & MICRONIZED) (1)

87 GENTAMICIN SULFATE (1)

88 HYDROCORTISONE 17-VALERATE (1)

89 HYDROCORTISONE 21-HYDROGEN, SUCCINATE, BULK, NON-STERILE (1)

90 IBUPROFEN (1)

91 IMIPENEM (STERILE BULK) (1)

92 IMIPENEM AND CILASTATIN (STERILE BULK) (1)

93 MANUFACTURING FACILITIES, PERSONNEL, AND GENERAL OPERATIONS IN BERGAMO, ITALY (1)

94 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN RODANO, ITALY. (1)

95 MEDROXYPROGESTERONE ACETATE (1)

96 MEDRYSONE USP XIX, NON-MICRONIZED AND MICRONIZED (1)

97 MEROPENEM FOR INJECTION (1)

98 MEROPENEM TRIHYDRATE NON STERILE (1)

99 MEROPENEM TRIHYDRATE STERILE (1)

100 METHYLDOPA USP (1)

101 METHYLPREDNISOLONE AND METHYLPEDNISOLONE ACETATE (1)

102 NAFCILLIN SODIUM (1)

103 NAFCILLIN SODIUM FOR INJECTION (BULK) (1)

104 NAFCILLIN SODIUM FOR INJECTION (STERILE BULK) (1)

105 NON-STERILE BETAMETHASONE (BULK) (1)

106 O-FORMYL CEFAMANDOLE ACETONITRILE SOLVATE (1)

107 OXACILLIN SODIUM (1)

108 OXACILLIN SODIUM MONOHYDRATE FOR INJECTION (1)

109 PENICILLIN G INTERMEDIATES (1)

110 PENICILLIN G POTASSIUM (1)

111 PENICILLIN G POTASSIUM FOR INJECTION, USP (STERILE BULK) (1)

112 PENICILLIN G POTASSIUM STERILE (1)

113 PERSONNEL, FACILITIES AND GENERAL OPERATING PROCEDURES (1)

114 PHOSPHATE SODIUM DIBASIC STERILE (1)

115 PIPERACILLIN AND TAZOBACTAM (STERILE BULK) (1)

116 PREDNACINOLONE ALCOHOL, MICRONIZED & NON MICRONIZED (1)

117 PREDNISOLONE SODIUM PHOSPHATE BULK (1)

118 PROGESTERONE 16a, 17a- ACETOPHENIDE (1)

119 SODIUM BICARBONATE, STERILE (1)

120 SODIUM CARBONATE LYOPHILIZED STERILE (1)

121 SODIUM CARBONATE STERILE (1)

122 SODIUM CARBONATE STERILE LYOPHILIZED (1)

123 SPIRONOLACTONE (1)

124 STERILE SODIUM CARBONATE (1)

125 STERILE TRISODIUM CITRATE DIHYDRATE (1)

126 STERILE VANCOMYCIN HYDROCHLORIDE USP, 100G (1)

127 SULBACTAM SODIUM USP (STERILE BULK) (1)

128 TACROLIMUS MONOHYDRATE (1)

129 TETRACYCLINE PHOSPHATE COMPLEX (1)

130 THYMIC HUMORAL FACTOR GAMMA 2 ACTIVE DRUG SUBS. - MILAN,ITALY (1)

131 THYMIC HUMORAL FACTOR GAMMA 2 FINISHED DOSAGE, MILAN ITALY (1)

132 TRIAMCINOLONE (1)

133 TRIAMCINOLONE ACETONIDE (1)

134 TRIAMCINOLONE DIACETATE (1)

135 TRIPROLIDINE HCL. BULK FORM (1)

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01 ACS DOBFAR SPA (76)

02 ACS DOBFAR UK LTD (2)

03 ANTIBIOTICOS DO BRASIL LTDA (5)

04 ANTIBIOTICOS INC (4)

05 ANTIBIOTICOS SA (6)

06 ANTIBIOTICOS SPA (44)

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01 Brazil (1)

02 Italy (135)

03 U.S.A (1)

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01 Active (58)

02 Inactive (79)

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01 Complete (12)

02 Blank (125)

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ANTIBIOTICOS SPA
Inactive
3201
N/A
1978-05-11
II
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ANTIBIOTICOS SPA
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3555
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1979-07-12
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ANTIBIOTICOS SPA
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3109
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1977-12-27
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ANTIBIOTICOS SA
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12348
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1997-01-31
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ACS DOBFAR UK LTD
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17144
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2004-02-04
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ACS DOBFAR SPA
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16036
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2002-06-20
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ACS DOBFAR SPA
Inactive
8852
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1990-11-21
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ANTIBIOTICOS SA
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15829
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2002-01-28
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ACS DOBFAR SPA
Active
11657
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1995-08-18
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ACS DOBFAR SPA
Active
10303
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1987-04-01
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