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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13661
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : CEP 2004-303 - Rev 05
Issue Date : 2025-04-10
Type : Chemical
Substance Number : 578
Status : Valid
Registration Number : 219MF10051
Registrant's Address : Viale Addetta, 4/12, 20067 Tribiano (Milan) Italy
Initial Date of Registration : 2007-02-13
Latest Date of Registration :
NDC Package Code : 52946-0705
Start Marketing Date : 2009-12-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg 1kg/kg)
Marketing Category : DRUG FOR FURTHER PRO...
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13780
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : R1-CEP 1996-008 - Rev 04
Issue Date : 2020-12-17
Type : Chemical
Substance Number : 986
Status : Valid
Registration Number : 218MF10591
Registrant's Address : Viale Addetta, 4/12, 20067 Tribiano (Milan) Italy
Initial Date of Registration : 2006-06-22
Latest Date of Registration :
NDC Package Code : 52946-0912
Start Marketing Date : 2009-12-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kyungbo Pharmaceutical Co., Ltd.
Registration Date : 2020-05-11
Registration Number : 20050831-20-A-17-02(20)
Manufacturer Name : ACS DOBFAR SpA
Manufacturer Address : Via Marzabotto, 1, 7/9 - 20871 Vimercate (MB), Italy
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13208
Submission : 1998-04-30
Status : Active
Type : II
Certificate Number : R1-CEP 1996-083 - Rev 06
Issue Date : 2019-06-17
Type : Chemical
Substance Number : 988
Status : Valid
Registration Number : 222MF10020
Registrant's Address : Viale Addetta, 4/12, 20067 Tribiano (Milan) Italy
Initial Date of Registration : 2010-01-22
Latest Date of Registration :
NDC Package Code : 52946-0801
Start Marketing Date : 2009-12-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2021-04-27
Registration Number : 20210427-210-J-635
Manufacturer Name : ACS Dobfar SpA
Manufacturer Address : Viale Addetta, 2a/12-3/5 20067 Tribiano, Milano, Italy
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13683
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : CEP 2023-299 - Rev 00
Issue Date : 2024-07-29
Type : Chemical
Substance Number : 1405
Status : Valid
Registration Number : 305MF10039
Registrant's Address : Viale Addetta, 4/12, 20067 Tribiano (Milan) Italy
Initial Date of Registration : 2023-03-23
Latest Date of Registration :
NDC Package Code : 52946-0924
Start Marketing Date : 2019-05-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2022-12-22
Registration Number : 20221222-210-J-1424
Manufacturer Name : ACS Dobfar SpA@ACS DOBFAR SpA
Manufacturer Address : Viale Addetta, 2a/12–3/5, 20067 Tribiano (MI), Italy@Via Marzabotto, 1, 7/9 20871 Vimercate (MB), Italy
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-08-01
Pay. Date : 2017-07-06
DMF Number : 22503
Submission : 2009-02-04
Status : Active
Type : II
Certificate Number : R1-CEP 2011-238 - Rev 01
Issue Date : 2022-01-20
Type : Chemical
Substance Number : 2234
Status : Valid
Registration Number : 306MF10149
Registrant's Address : Viale Addetta, 4/12, 20067 Tribiano (Milan) Italy
Initial Date of Registration : 2024-11-20
Latest Date of Registration :
NDC Package Code : 52946-0839
Start Marketing Date : 2009-12-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Yuhan Corporation
Registration Date : 2020-07-31
Registration Number : 20200302-210-J-504(4)
Manufacturer Name : ACS Dobfar SpA
Manufacturer Address : Viale Addetta, 2a/12 – 3/5 20067 Tribiano (Milano), Italy
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-12-05
Pay. Date : 2013-07-05
DMF Number : 13763
Submission : 1998-09-01
Status : Active
Type : II
Registration Number : 301MF10052
Registrant's Address : Viale Addetta, 4/12, 20067 Tribiano (Milan) Italy
Initial Date of Registration : 2019-08-28
Latest Date of Registration :
NDC Package Code : 52946-0600
Start Marketing Date : 2009-12-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13225
Submission : 1998-04-30
Status : Active
Type : II
Certificate Number : R1-CEP 1999-174 - Rev 04
Issue Date : 2023-06-14
Type : Chemical
Substance Number : 813
Status : Valid
NDC Package Code : 52946-0903
Start Marketing Date : 2009-12-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Daewoong Bio Co., Ltd.
Registration Date : 2019-04-01
Registration Number : 20050831-19-A-11-02(9)
Manufacturer Name : ACS DOBFAR SpA
Manufacturer Address : Via Marzabotto, 7/9 20871 Vimercate (MB)-Italy
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14367
Submission : 1999-08-25
Status : Active
Type : II
Certificate Number : R1-CEP 1998-050 - Rev 03
Issue Date : 2008-02-28
Type : Chemical
Substance Number : 989
Status : Valid
NDC Package Code : 52946-0826
Start Marketing Date : 2009-12-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13205
Submission : 1998-04-30
Status : Active
Type : II
Certificate Number : R1-CEP 1996-007 - Rev 05
Issue Date : 2022-07-25
Type : Chemical
Substance Number : 992
Status : Valid
NDC Package Code : 52946-0905
Start Marketing Date : 2009-12-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13588
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : CEP 1996-099 - Rev 04
Issue Date : 2023-12-06
Type : Chemical
Substance Number : 708
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3201
Submission : 1978-05-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3555
Submission : 1979-07-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3109
Submission : 1977-12-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12348
Submission : 1997-01-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17144
Submission : 2004-02-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16036
Submission : 2002-06-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15829
Submission : 2002-01-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11657
Submission : 1995-08-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19167
Submission : 2006-02-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22732
Submission : 2009-04-15
Status : Inactive
Type : II
CEP/COS
Certificate Numbers : R1-CEP 1998-069 - Rev 01
Status : Valid
Issue Date : 2009-06-17
Type : Chemical
Substance Number : 577
Certificate Numbers : CEP 2004-303 - Rev 05
Status : Valid
Issue Date : 2025-04-10
Type : Chemical
Substance Number : 578
CEP/COS
Certificate Numbers : R1-CEP 1996-008 - Rev 04
Status : Valid
Issue Date : 2020-12-17
Type : Chemical
Substance Number : 986
CEP/COS
Certificate Numbers : CEP 2023-429 - Rev 00
Status : Valid
Issue Date : 2024-05-24
Type : Chemical
Substance Number : 986
Certificate Numbers : R1-CEP 1999-174 - Rev 04
Status : Valid
Issue Date : 2023-06-14
Type : Chemical
Substance Number : 813
CEP/COS
Certificate Numbers : CEP 1996-099 - Rev 04
Status : Valid
Issue Date : 2023-12-06
Type : Chemical
Substance Number : 708
Certificate Numbers : CEP 1997-128 - Rev 04
Status : Valid
Issue Date : 2025-01-02
Type : Chemical
Substance Number : 708
CEP/COS
Certificate Numbers : R1-CEP 1996-083 - Rev 06
Status : Valid
Issue Date : 2019-06-17
Type : Chemical
Substance Number : 988
Certificate Numbers : R0-CEP 2023-021 - Rev 00
Status : Valid
Issue Date : 2023-07-27
Type : Chemical
Substance Number : 2126
CEP/COS
Certificate Numbers : R1-CEP 1998-050 - Rev 03
Status : Valid
Issue Date : 2008-02-28
Type : Chemical
Substance Number : 989
Regulatory Info : RX
Registration Country : USA
Dosage Form : SOLUTION;INTRAVENOUS
Brand Name : ACETAMINOPHEN
Dosage Strength : 1GM/100ML (10MG/ML)
Packaging :
Approval Date : 2023-05-03
Application Number : 215403
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : INJECTABLE;INJECTION
Brand Name : AMPICILLIN SODIUM
Dosage Strength : EQ 1GM BASE/VIAL
Packaging :
Approval Date : 2013-04-03
Application Number : 90884
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : INJECTABLE;INJECTION
Brand Name : AMPICILLIN SODIUM
Dosage Strength : EQ 10GM BASE/VIAL
Packaging :
Approval Date : 2013-04-03
Application Number : 90889
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : INJECTABLE;INJECTION
Brand Name : AMPICILLIN SODIUM
Dosage Strength : EQ 500MG BASE/VIAL
Packaging :
Approval Date : 2013-04-03
Application Number : 90884
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : INJECTABLE;INJECTION
Brand Name : AMPICILLIN SODIUM
Dosage Strength : EQ 2GM BASE/VIAL
Packaging :
Approval Date : 2013-04-03
Application Number : 90884
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
AMPICILLIN SODIUM; SULBACTAM SODIUM
Dosage Form : INJECTABLE;INJECTION
Brand Name : AMPICILLIN AND SULBACTAM
Dosage Strength : EQ 10GM BASE/VIAL;EQ 5...
Packaging :
Approval Date : 2009-12-23
Application Number : 65403
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
AMPICILLIN SODIUM; SULBACTAM SODIUM
Dosage Form : INJECTABLE;INJECTION
Brand Name : AMPICILLIN AND SULBACTAM
Dosage Strength : EQ 2GM BASE/VIAL;EQ 1G...
Packaging :
Approval Date : 2009-12-22
Application Number : 65406
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
AMPICILLIN SODIUM; SULBACTAM SODIUM
Dosage Form : INJECTABLE;INJECTION
Brand Name : AMPICILLIN AND SULBACTAM
Dosage Strength : EQ 1GM BASE/VIAL;EQ 50...
Packaging :
Approval Date : 2009-12-22
Application Number : 65406
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Italy
Dosage Form : Suspensions
Brand Name :
Dosage Strength : 125MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Dosage Form : Suspensions
Brand Name :
Dosage Strength : 250MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Inspections and registrations
ABOUT THIS PAGE
Facta Farmaceutici SPA is a supplier offers 146 products (APIs, Excipients or Intermediates).
Find a price of Ampicillin Sodium bulk with DMF, CEP, JDMF offered by Facta Farmaceutici SPA
Find a price of Cefaclor bulk with DMF, CEP, JDMF offered by Facta Farmaceutici SPA
Find a price of Cefazolin Sodium bulk with DMF, CEP, JDMF offered by Facta Farmaceutici SPA
Find a price of Ceftazidime bulk with DMF, CEP, JDMF offered by Facta Farmaceutici SPA
Find a price of Meropenem bulk with DMF, CEP, JDMF offered by Facta Farmaceutici SPA
Find a price of Amikacin Sulfate bulk with DMF, JDMF offered by Facta Farmaceutici SPA
Find a price of Cefaclor bulk with CEP, JDMF offered by Facta Farmaceutici SPA
Find a price of Cefadroxil bulk with DMF, CEP offered by Facta Farmaceutici SPA
Find a price of Cefepime bulk with DMF, CEP offered by Facta Farmaceutici SPA
Find a price of Cefotaxime bulk with DMF, CEP offered by Facta Farmaceutici SPA
Find a price of Ceftriaxone bulk with DMF, CEP offered by Facta Farmaceutici SPA
Find a price of Cefuroxime Sodium bulk with DMF, CEP offered by Facta Farmaceutici SPA
Find a price of Cephalexin Monohydrate bulk with DMF, CEP offered by Facta Farmaceutici SPA
Find a price of Cilastatin Sodium bulk with DMF, JDMF offered by Facta Farmaceutici SPA
Find a price of Clindamycin Phosphate bulk with DMF, CEP offered by Facta Farmaceutici SPA
Find a price of Sulbactam Sodium bulk with DMF, JDMF offered by Facta Farmaceutici SPA
Find a price of Clindamycin Hydrochloride bulk with CEP offered by Facta Farmaceutici SPA
Find a price of 6-Aminopenicillanic Acid bulk with DMF offered by Facta Farmaceutici SPA
Find a price of 7-Amino-3-[(5-Methyl-1,3,4-Thiadiazol-2-Yl)Thiomethyl]Cephalosphoranic Acid bulk with DMF offered by Facta Farmaceutici SPA
Find a price of Alpha-Amino-3-Hydroxy-5-Methyl-4-Isoxazolepropionic Acid bulk with DMF offered by Facta Farmaceutici SPA
Find a price of Amikacin bulk with DMF offered by Facta Farmaceutici SPA
Find a price of Amoxicillin Sodium bulk with CEP offered by Facta Farmaceutici SPA
Find a price of Amoxicillin Trihydrate bulk with DMF offered by Facta Farmaceutici SPA
Find a price of Ampicillin Sodium bulk with DMF offered by Facta Farmaceutici SPA
Find a price of Ampicillin Trihydrate bulk with DMF offered by Facta Farmaceutici SPA
Find a price of Carbopol 940 API bulk with DMF offered by Facta Farmaceutici SPA
Find a price of Cefalotin sodium Sterile bulk with DMF offered by Facta Farmaceutici SPA
Find a price of Cefepime Hydrochloride bulk with DMF offered by Facta Farmaceutici SPA
Find a price of Cefotaxime bulk with DMF offered by Facta Farmaceutici SPA
Find a price of Cefotetan bulk with DMF offered by Facta Farmaceutici SPA
Find a price of Cefotetan Disodium bulk with DMF offered by Facta Farmaceutici SPA
Find a price of Cefoxitin bulk with DMF offered by Facta Farmaceutici SPA
Find a price of Cefoxitin Sodium bulk with DMF offered by Facta Farmaceutici SPA
Find a price of Ceftaroline Fosamil bulk with DMF offered by Facta Farmaceutici SPA
Find a price of Ceftazidime bulk with DMF offered by Facta Farmaceutici SPA
Find a price of Cefuroxime Axetil bulk with DMF offered by Facta Farmaceutici SPA
Find a price of Cephalexin bulk with JDMF offered by Facta Farmaceutici SPA
Find a price of Cephapirin bulk with DMF offered by Facta Farmaceutici SPA
Find a price of Cephapirin Sodium bulk with DMF offered by Facta Farmaceutici SPA
Find a price of Ertapenem Sodium bulk with DMF offered by Facta Farmaceutici SPA
Find a price of Gentamicin Sulfate bulk with DMF offered by Facta Farmaceutici SPA
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Find a price of Nafcillin Sodium bulk with DMF offered by Facta Farmaceutici SPA
Find a price of Penicillin G Potassium bulk with DMF offered by Facta Farmaceutici SPA
Find a price of Piperacillin + Tazobactam bulk with DMF offered by Facta Farmaceutici SPA
Find a price of Sodium Bicarbonate bulk with DMF offered by Facta Farmaceutici SPA
Find a price of Sodium Carbonate bulk with DMF offered by Facta Farmaceutici SPA
Find a price of Trisodium Citrate Dihydrate bulk with DMF offered by Facta Farmaceutici SPA
Find a price of DEFU (DECARBAMOYLCEFUROXINE) bulk with DMF offered by Facta Farmaceutici SPA
Find a price of TAZOBACTAM SODIUM STERILE bulk with DMF offered by Facta Farmaceutici SPA
Find a price of 6-Aminopenicillanic Acid bulk offered by Facta Farmaceutici SPA
Find a price of 7-Aminodesacetoxycephalosporanic Acid bulk offered by Facta Farmaceutici SPA
Find a price of Amikacin Sulfate bulk offered by Facta Farmaceutici SPA
Find a price of Beclomethasone Dipropionate bulk offered by Facta Farmaceutici SPA
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Find a price of Carbopol 940 API bulk offered by Facta Farmaceutici SPA
Find a price of Cefadroxil bulk offered by Facta Farmaceutici SPA
Find a price of Cefalotin sodium Sterile bulk offered by Facta Farmaceutici SPA
Find a price of Cefamandole Nafate bulk offered by Facta Farmaceutici SPA
Find a price of Cefazolin bulk offered by Facta Farmaceutici SPA
Find a price of Cefazolin Sodium bulk offered by Facta Farmaceutici SPA
Find a price of Cefepime Hydrochloride bulk offered by Facta Farmaceutici SPA
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Find a price of Clindamycin Phosphate bulk offered by Facta Farmaceutici SPA
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Find a price of Dexamethasone bulk offered by Facta Farmaceutici SPA
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Find a price of Ethanol bulk offered by Facta Farmaceutici SPA
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Find a price of Hydroxyprogesterone Caproate bulk offered by Facta Farmaceutici SPA
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Find a price of Penicillin G Potassium bulk offered by Facta Farmaceutici SPA
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Find a price of Progesterone bulk offered by Facta Farmaceutici SPA
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Find a price of Triprolidine Hydrochloride bulk offered by Facta Farmaceutici SPA
Find a price of Vancomycin Hydrochloride bulk offered by Facta Farmaceutici SPA
Find a price of MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN RODANO, ITALY. bulk offered by Facta Farmaceutici SPA
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