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    Company profile for ACS DOBFAR SPA

    Coral

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    China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress

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    AMI Lifesciences is Driven by Chemistry. Powered by People.

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    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    Alchem offers Botanical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.

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    pharmacompass-2-m-2026-04-20

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    EVENTS

    DIGITAL CONTENT

    ACTIVE PHARMA INGREDIENTS

    FINISHED DOSAGE FORMULATIONS

    INSPECTIONS & REGISTRATIONS

    PharmaCompass

    Only Regulatory Products (API/FDF), Drugs in Developments and News are Updated on this Virtual Booth

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    About

    We are a privately held Italian company founded in 1973. We are a fully integrated manufacturer of Cephalosporin, Carbapenem and Penicillin APIs as well as Finished Dosage Formulations (Solid and Injectable). We export our products to MORE than 100 countries all over the world. Our production sites, most of them regularly inspected by EUROPEN AND USA AUTHORITIES (FDA), have strict Quality Standards and our R&D Know-how ma...
    We are a privately held Italian company founded in 1973. We are a fully integrated manufacturer of Cephalosporin, Carbapenem and Penicillin APIs as well as Finished Dosage Formulations (Solid and Injectable). We export our products to MORE than 100 countries all over the world. Our production sites, most of them regularly inspected by EUROPEN AND USA AUTHORITIES (FDA), have strict Quality Standards and our R&D Know-how make us a leading company. Our Commitment: to work in the present while concentrating on the future, because on markets where research and technology are factors of primary importance.

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    CONTACT DETAILS

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    ACS DOBFAR SPAItaly Flag
    Country
    Country
    Italy
    Address
    Address
    Viale Addetta 4/12 20067 Tribiano (Milan)
    Telephone
    Telephone
    +39-029-069-31
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.acsdobfar.it/
    Linkedin
    Linkedin
    youtube
    YouTube
    Twitter
    Twitter

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    Events

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    PEGS Boston Summit

    PEGS Boston Summit

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    Meeting

    Digital content

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    NEWS #PharmaBuzz

    read-more
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    Dobfar's Generic Cefepime Hydrochloride Receives Approval in the U.S.
    Dobfar's Generic Cefepime Hydrochloride Receives Approval in the U.S.

    03 Jan 2022

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=065441

    FDA
    03 Jan 2022
    Share Share
    ACS Dobfar SPA's Generic Penicillin G Potassium Receives Approval in US
    ACS Dobfar SPA's Generic Penicillin G Potassium Receives Approval in US

    31 Oct 2018

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205043

    FDA
    31 Oct 2018
    Share Share
    Acs Dobfar Generic Ertapenem Sodium Receives Approval In US
    Acs Dobfar Generic Ertapenem Sodium Receives Approval In US

    19 Apr 2018

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208790

    FDA
    19 Apr 2018
    Share Share
    FDA Cites Three Pharma, Five Medical Device Companies
    FDA Cites Three Pharma, Five Medical Device Companies

    01 Feb 2017

    // PHARMA MANUFACTURING

    http://www.pharmamanufacturing.com/industrynews/2017/fda-cites-three-pharma-five-medical-device-companies/

    PHARMA MANUFACTURING
    01 Feb 2017
    Share Share
    FACTA Farmaceutici Receives FDA Warning Letter
    FACTA Farmaceutici Receives FDA Warning Letter

    13 Jan 2017

    // FDA

    https://www.pharmacompass.com/pdf/news/facta-farmaceutici-receives-fda-warning-letter-1485923976.pdf

    FDA
    13 Jan 2017
    Share Share

    ALL APIs

    read-moreClick the button for full data set
    read-moreClick the button for full data set

    01

    Ampicillin Sodium

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PEGS Boston Summit
    Not Confirmed
    arrow

    Ampicillin Sodium

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13661

    Submission : 1998-09-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2004-303 - Rev 05

    Issue Date : 2025-04-10

    Type : Chemical

    Substance Number : 578

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 307MF10065

    Registrant's Address : Viale Addetta, 4/12, 20067 Tribiano (Milan) Italy

    Initial Date of Registration : 2025-06-04

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52946-0705

    Start Marketing Date : 2009-12-09

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg 1kg/kg)

    Marketing Category : DRUG FOR FURTHER PRO...

    KDMF VMF Others AUDIT arrow-down
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    Product
    Web Link

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    Market
    Place

    02

    Cefaclor

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PEGS Boston Summit
    Not Confirmed
    arrow

    Cefaclor

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13780

    Submission : 1998-09-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2023-429 - Rev 00

    Issue Date : 2024-05-24

    Type : Chemical

    Substance Number : 986

    Status : Valid

     JDMF arrow-down
    ✖

    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 :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52946-0912

    Start Marketing Date : 2009-12-09

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    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

     VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

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    Market
    Place

    03

    Cefazolin Sodium

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PEGS Boston Summit
    Not Confirmed
    arrow

    Cefazolin Sodium

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13208

    Submission : 1998-04-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 1996-083 - Rev 07

    Issue Date : 2025-12-16

    Type : Chemical

    Substance Number : 988

    Status : Valid

     JDMF arrow-down
    ✖

    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 :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52946-0801

    Start Marketing Date : 2009-12-09

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    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

     VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

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    Market
    Place

    04

    Ceftazidime

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PEGS Boston Summit
    Not Confirmed
    arrow

    Ceftazidime

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13683

    Submission : 1998-09-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2023-299 - Rev 00

    Issue Date : 2024-07-29

    Type : Chemical

    Substance Number : 1405

    Status : Valid

     JDMF arrow-down
    ✖

    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 :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52946-0924

    Start Marketing Date : 2019-05-22

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Pfizer Korea

    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

     VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Meropenem

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PEGS Boston Summit
    Not Confirmed
    arrow

    Meropenem

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    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

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2011-238 - Rev 01

    Issue Date : 2022-01-20

    Type : Chemical

    Substance Number : 2234

    Status : Valid

     JDMF arrow-down
    ✖

    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 :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52946-0839

    Start Marketing Date : 2009-12-09

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    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

     VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

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    #PipelineProspector

    Market
    Place

    06

    Amikacin Sulfate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PEGS Boston Summit
    Not Confirmed
    arrow

    Amikacin Sulfate

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    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

     CEP/COS JDMF arrow-down
    ✖

    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 :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52946-0600

    Start Marketing Date : 2009-12-09

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Cefadroxil

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PEGS Boston Summit
    Not Confirmed
    arrow

    Cefadroxil

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13225

    Submission : 1998-04-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1999-174 - Rev 04

    Issue Date : 2023-06-14

    Type : Chemical

    Substance Number : 813

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52946-0903

    Start Marketing Date : 2009-12-09

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    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

     VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

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    #PipelineProspector

    Market
    Place

    08

    Cefotaxime

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PEGS Boston Summit
    Not Confirmed
    arrow

    Cefotaxime

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14367

    Submission : 1999-08-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1998-050 - Rev 03

    Issue Date : 2008-02-28

    Type : Chemical

    Substance Number : 989

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52946-0826

    Start Marketing Date : 2009-12-09

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Cefuroxime Sodium

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PEGS Boston Summit
    Not Confirmed
    arrow

    Cefuroxime Sodium

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13205

    Submission : 1998-04-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1996-007 - Rev 05

    Issue Date : 2022-07-25

    Type : Chemical

    Substance Number : 992

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52946-0905

    Start Marketing Date : 2009-12-09

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    10

    Cephalexin Monohydrate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PEGS Boston Summit
    Not Confirmed
    arrow

    Cephalexin Monohydrate

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13588

    Submission : 1998-09-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 1997-128 - Rev 04

    Issue Date : 2025-01-02

    Type : Chemical

    Substance Number : 708

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    Only 10 entries up to this point, click to access all click full view read-more
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    ABOUT THIS PAGE

    Contact ACS DOBFAR SPA and get a quotation

    ACS DOBFAR SPA is a supplier offers 141 products (APIs, Excipients or Intermediates).

    Find Ampicillin Sodium bulk with DMF, CEP, JDMF offered by ACS DOBFAR SPA

    Find Cefaclor bulk with DMF, CEP, JDMF offered by ACS DOBFAR SPA

    Find Cefazolin Sodium bulk with DMF, CEP, JDMF offered by ACS DOBFAR SPA

    Find Ceftazidime bulk with DMF, CEP, JDMF offered by ACS DOBFAR SPA

    Find Meropenem bulk with DMF, CEP, JDMF offered by ACS DOBFAR SPA

    Find Amikacin Sulfate bulk with DMF, JDMF offered by ACS DOBFAR SPA

    Find Ampicillin Sodium bulk with DMF, JDMF offered by ACS DOBFAR SPA

    Find Cefaclor bulk with CEP, JDMF offered by ACS DOBFAR SPA

    Find Cefadroxil bulk with DMF, CEP offered by ACS DOBFAR SPA

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    Find Cephalexin Monohydrate bulk with DMF, CEP offered by ACS DOBFAR SPA

    Find Cilastatin Sodium bulk with DMF, JDMF offered by ACS DOBFAR SPA

    Find Clindamycin Phosphate bulk with DMF, CEP offered by ACS DOBFAR SPA

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    Find 6-Aminopenicillanic Acid bulk with DMF offered by ACS DOBFAR SPA

    Find 7-Amino-3-[(5-Methyl-1,3,4-Thiadiazol-2-Yl)Thiomethyl]Cephalosphoranic Acid bulk with DMF offered by ACS DOBFAR SPA

    Find Alpha-Amino-3-Hydroxy-5-Methyl-4-Isoxazolepropionic Acid bulk with DMF offered by ACS DOBFAR SPA

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    Find Amoxicillin Sodium bulk with CEP offered by ACS DOBFAR SPA

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