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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Acs Dobfar Spa

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01 113479-65-5 (1)

02 6-Aminopenicillanic Acid (2)

03 7-Amino-3-[(5-Methyl-1,3,4-Thiadiazol-2-Yl)Thiomethyl]Cephalosphoranic Acid (1)

04 7-Aminodesacetoxycephalosporanic Acid (2)

05 Alpha-Amino-3-Hydroxy-5-Methyl-4-Isoxazolepropionic Acid (1)

06 Amikacin (1)

07 Amikacin Sulfate (2)

08 Amoxicillin Sodium (1)

09 Amoxicillin Trihydrate (1)

10 Amphotericin B (1)

11 Ampicillin (1)

12 Ampicillin Sodium (2)

13 Ampicillin Trihydrate (1)

14 Beclomethasone Dipropionate (1)

15 Benzyl Penicillin (1)

16 Betamethasone (1)

17 Betamethasone Sodium Phosphate (1)

18 Betamethasone Valerate (1)

19 Biapenem (1)

20 Bombesin Tyr4 (1)

21 Cabergoline (2)

22 Carbopol 940 API (2)

23 Cefaclor (2)

24 Cefadroxil (2)

25 Cefadroxil Monohydrate (1)

26 Cefalotin sodium Sterile (5)

27 Cefamandole Nafate (1)

28 Cefazolin (2)

29 Cefazolin Sodium (2)

30 Cefepime (2)

31 Cefepime Hydrochloride (2)

32 Cefixime (1)

33 Cefoperazone Sodium (1)

34 Cefotaxime (2)

35 Cefotetan (1)

36 Cefotetan Disodium (1)

37 Cefoxitin (1)

38 Cefoxitin Sodium (3)

39 Cefprozil (1)

40 Ceftaroline Fosamil (1)

41 Ceftazidime (4)

42 Ceftriaxone (4)

43 Cefuroxime Axetil (1)

44 Cefuroxime Sodium (1)

45 Cephalexin (1)

46 Cephalexin Monohydrate (2)

47 Cephapirin (1)

48 Cephapirin Benzathine (1)

49 Cephapirin Sodium (1)

50 Cephradine (1)

51 Cephradine Monohydrate (1)

52 Cilastatin Sodium (1)

53 Clindamycin Hydrochloride (1)

54 Clindamycin Phosphate (2)

55 Cloxacillin Benzathine (1)

56 Cloxacillin Sodium (1)

57 Desonide (1)

58 Dexamethasone (1)

59 Dexamethasone Sodium Phosphate (2)

60 Disodium Hydrogen Phosphate (1)

61 Doripenem (1)

62 Endrysone (1)

63 Ertapenem Sodium (1)

64 Ethanol (1)

65 Flucloxacillin Sodium (1)

66 Flumethasone (1)

67 Flumethasone Pivalate (1)

68 Fluocinolone Acetonide (1)

69 Fluocinonide (1)

70 Fluorometholone (1)

71 Fluorometholone Acetate (1)

72 Flurandrenolone (1)

73 Gentamicin Sulfate (1)

74 Hydrocortisone Sodium Succinate (1)

75 Hydrocortisone Valerate (1)

76 Hydroxyprogesterone Caproate (1)

77 Ibuprofen (1)

78 Imipenem (2)

79 L-Arginine (1)

80 L-Arginine Hydrochloride API (2)

81 Medroxyprogesterone Acetate (1)

82 Medrysone (1)

83 Meropenem (3)

84 Methyldopa (1)

85 Methylprednisolone Acetate (1)

86 Methylprednisolone Hemisuccinate (1)

87 Mono Propylene Glycol (1)

88 Nafcillin (1)

89 Nafcillin Sodium (3)

90 Oxacillin Sodium (2)

91 Penicillin G Potassium (3)

92 Piperacillin + Tazobactam (1)

93 Piperacillin Sodium (1)

94 Prednisolone Sodium Phosphate (1)

95 Progesterone (2)

96 Sodium Bicarbonate (1)

97 Sodium Carbonate (2)

98 Spironolactone (1)

99 Sulbactam Sodium (1)

100 Tacrolimus (1)

101 Tetracycline Phosphate (1)

102 Triamcinolone (1)

103 Triamcinolone Acetonide (1)

104 Triamcinolone Diacetate (1)

105 Triprolidine Hcl (1)

106 Trisodium Citrate Dihydrate (1)

107 Vancomycin Hydrochloride (1)

108 Blank (11)

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01 Active (58)

02 Inactive (79)

03 Blank (20)

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01 Valid (16)

02 Withdrawn by Holder (2)

03 Blank (139)

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01 218MF10523 (1)

02 218MF10590 (1)

03 218MF10591 (1)

04 219MF10051 (1)

05 219MF10341 (1)

06 222MF10020 (1)

07 222MF10129 (1)

08 227MF10171 (1)

09 228MF10054 (1)

10 301MF10052 (1)

11 304MF10136 (1)

12 305MF10039 (1)

13 Blank (145)

filter

01 Blank (157)

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USDMF

Found USDMF

13661
Active
AMPICILLIN SODIUM (STERILE BULK)
1998-09-01
CEP/COS

Found CEP/COS

CEP 2004-303 - Rev 03
Valid
Ampicillin sodium, Sterile and bact...
2024-01-24
Japanese DMF

Found JDMF

219MF10051
Ampicillin sodium at Viale Addetta,...
2007-02-13
Written Confirmation

Close WC

Application Number
13661
219MF10051
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
AMPICILLIN SODIUM (STERILE BULK)
Ampicillin sodium, Sterile and bact...
Ampicillin sodium at Viale Addetta,...
Issue/Submission Date
1998-09-01
2024-01-24
2007-02-13
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USDMF

Found USDMF

13780
Active
CEFACLOR MONOHYDRATE
1998-09-01
CEP/COS

Found CEP/COS

R1-CEP 1996-008 - Rev 04
Valid
Cefaclor
2020-12-17
Japanese DMF

Found JDMF

218MF10591
Cefaclor at Viale Addetta, 4/12, 20...
2006-06-22
Written Confirmation

Close WC

Application Number
13780
218MF10591
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
CEFACLOR MONOHYDRATE
Cefaclor
Cefaclor at Viale Addetta, 4/12, 20...
Issue/Submission Date
1998-09-01
2020-12-17
2006-06-22
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USDMF

Found USDMF

13208
Active
CEFAZOLIN SODIUM LYOPHILIZED (STERI...
1998-04-30
CEP/COS

Found CEP/COS

R1-CEP 1996-083 - Rev 06
Valid
Cefazolin sodium, Sterile
2019-06-17
Japanese DMF

Found JDMF

222MF10020
Cefazolin sodium at Viale Addetta, ...
2010-01-22
Written Confirmation

Close WC

Application Number
13208
222MF10020
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
CEFAZOLIN SODIUM LYOPHILIZED (STERI...
Cefazolin sodium, Sterile
Cefazolin sodium at Viale Addetta, ...
Issue/Submission Date
1998-04-30
2019-06-17
2010-01-22
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USDMF

Found USDMF

13763
Active
AMIKACIN SULFATE
1998-09-01
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

301MF10052
Amikacin Sulfate at Viale Addetta, ...
2019-08-28
Written Confirmation

Close WC

Application Number
13763
301MF10052
Status
Active
Fees Paid
Reviewed
 
Filing Details
AMIKACIN SULFATE
Amikacin Sulfate at Viale Addetta, ...
Issue/Submission Date
1998-09-01
2019-08-28
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USDMF

Found USDMF

24395
Active
CEFEPIME FOR INJECTION (STERILE BUL...
2011-03-31
CEP/COS

Found CEP/COS

R0-CEP 2023-021 - Rev 00
Valid
Cefepime dihydrochloride monohydrat...
2023-07-27
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
24395
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
CEFEPIME FOR INJECTION (STERILE BUL...
Cefepime dihydrochloride monohydrat...
Issue/Submission Date
2011-03-31
2023-07-27
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USDMF

Found USDMF

14367
Active
CEFOTAXIME SODIUM STERILE
1999-08-25
CEP/COS

Found CEP/COS

R1-CEP 1998-050 - Rev 03
Valid
Cefotaxime sodium, Sterile
2008-02-28
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
14367
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
CEFOTAXIME SODIUM STERILE
Cefotaxime sodium, Sterile
Issue/Submission Date
1999-08-25
2008-02-28
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USDMF

Found USDMF

13683
Active
CEFTAZIDIME FOR INJECTION USP (STER...
1998-09-01
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

305MF10039
Ceftazidime Hydrate at Viale Addett...
2023-03-23
Written Confirmation

Close WC

Application Number
13683
305MF10039
Status
Active
Fees Paid
N/A
 
Filing Details
CEFTAZIDIME FOR INJECTION USP (STER...
Ceftazidime Hydrate at Viale Addett...
Issue/Submission Date
1998-09-01
2023-03-23
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USDMF

Found USDMF

17259
Active
CEFTRIAXONE SODIUM, USP (STERILE BU...
2004-03-25
CEP/COS

Found CEP/COS

R1-CEP 2003-169 - Rev 01
Valid
Ceftriaxone sodium, sterile and bac...
2011-02-18
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
17259
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
CEFTRIAXONE SODIUM, USP (STERILE BU...
Ceftriaxone sodium, sterile and bac...
Issue/Submission Date
2004-03-25
2011-02-18
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USDMF

Found USDMF

17541
Active
CEFTRIAXONE SODIUM NON STERILE USP
2004-07-01
CEP/COS

Found CEP/COS

R1-CEP 2011-393 - Rev 02
Valid
Ceftriaxone sodium, Sterile
2022-03-03
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
17541
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
CEFTRIAXONE SODIUM NON STERILE USP
Ceftriaxone sodium, Sterile
Issue/Submission Date
2004-07-01
2022-03-03
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USDMF

Found USDMF

13205
Active
CEFUROXIME SODIUM (STERILE BULK)
1998-04-30
CEP/COS

Found CEP/COS

R1-CEP 1996-007 - Rev 05
Valid
Cefuroxime sodium, Sterile
2022-07-25
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
13205
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
CEFUROXIME SODIUM (STERILE BULK)
Cefuroxime sodium, Sterile
Issue/Submission Date
1998-04-30
2022-07-25
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