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    Company profile for ACS DOBFAR SPA

    FAMAR CDMO- From early development to commercial manufacturing.

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    Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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    AbbVie Contract Manufacturing partners globally to develop, scale, and manufacture pharmaceutical products successfully.

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    EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    EVENTS

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    ACTIVE PHARMA INGREDIENTS

    FINISHED DOSAGE FORMULATIONS

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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/
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    Linkedin
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    Twitter

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    NEWS #PharmaBuzz

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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
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    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
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    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
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    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
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    USDMF

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    01

    17a-hydroxyprogesterone Caproate Usp...

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    02

    17a-hydroxyprogesterone, Bulk

    Italy
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    03

    6-alpha-methylprednisolone-21-hydrog...

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    04

    6-amino Penicillanic Acid

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    05

    6-aminopenicillanic Acid (6-apa)

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    06

    7-adca (7-amino-3-desacetoxy Cephalo...

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    07

    7-amino-deacetoxy-cephalosporanic Ac...

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    08

    7-zaca- 7-amino-3-[2-(5-metbyl-1,3,4...

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    09

    Acid Cefotetan

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    Amikacin 1.8 Sulphate

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    Brand Name : ACETAMINOPHEN

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    Brand Name : ACETAMINOPHEN

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    Regulatory Info : RX

    Registration Country : USA

    ACETAMINOPHEN

    ACS DOBFAR SPA

    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

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    Brand Name : AMPICILLIN SODIUM

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    Regulatory Info : DISCN

    Registration Country : USA

    AMPICILLIN SODIUM

    ACS DOBFAR SPA

    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

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    Brand Name : AMPICILLIN SODIUM

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    Regulatory Info : DISCN

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    AMPICILLIN SODIUM

    ACS DOBFAR SPA

    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

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    Brand Name : AMPICILLIN SODIUM

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    Regulatory Info : DISCN

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    AMPICILLIN SODIUM

    ACS DOBFAR SPA

    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

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    Brand Name : AMPICILLIN SODIUM

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    Regulatory Info : RX

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    AMPICILLIN SODIUM

    ACS DOBFAR SPA

    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

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    Brand Name : AMPICILLIN AND SULBA...

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    AMPICILLIN SODIUM; SULBACTAM SODIUM

    ACS DOBFAR SPA

    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

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    Brand Name : AMPICILLIN AND SULBA...

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    Regulatory Info : RX

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    AMPICILLIN SODIUM; SULBACTAM SODIUM

    ACS DOBFAR SPA

    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

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    Brand Name : AMPICILLIN AND SULBA...

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    Regulatory Info : RX

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    AMPICILLIN SODIUM; SULBACTAM SODIUM

    ACS DOBFAR SPA

    Dosage Form : INJECTABLE;INJECTION

    Brand Name : AMPICILLIN AND SULBACTAM

    Dosage Strength : EQ 2GM BASE/VIAL;EQ 1G...

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    Approval Date : 2009-12-22

    Application Number : 65406

    Regulatory Info : RX

    Registration Country : USA

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    Brand Name : CEFACLOR

    Italy
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    Regulatory Info : DISCN

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    CEFACLOR

    ACS DOBFAR SPA

    Dosage Form : FOR SUSPENSION;ORAL

    Brand Name : CEFACLOR

    Dosage Strength : EQ 125MG BASE/5ML

    Packaging :

    Approval Date : 1982-01-01

    Application Number : 62206

    Regulatory Info : DISCN

    Registration Country : USA

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    Brand Name : CEFACLOR

    Italy
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    CEFACLOR

    ACS DOBFAR SPA

    Dosage Form : FOR SUSPENSION;ORAL

    Brand Name : CEFACLOR

    Dosage Strength : EQ 250MG BASE/5ML

    Packaging :

    Approval Date : 1982-01-01

    Application Number : 62206

    Regulatory Info : DISCN

    Registration Country : USA

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    FDA Orange Book

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    Inspections and registrations

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    FDA

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    01

    FDA Audited

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2023-11-23

    ACS DOBFAR SPA

    City : Tribiano

    State :

    Country/Area : Italy

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2023-11-23

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2023-10-27

    ACS DOBFAR SPA

    City : Verona

    State :

    Country/Area : Italy

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2023-10-27

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    FDA Audited

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2023-05-16

    ACS DOBFAR SPA

    City : Tribiano

    State :

    Country/Area : Italy

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2023-05-16

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    FDA Audited

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2022-10-14

    ACS DOBFAR SPA

    City : Anagni

    State :

    Country/Area : Italy

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2022-10-14

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    FDA Audited

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    District Decision : No Action Indicated

    Inspection End Date : 2022-05-27

    Antibioticos do Brasil Ltda

    City : Cosmopolis

    State :

    Country/Area : Brazil

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2022-05-27

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2022-04-08

    ACS DOBFAR SPA

    City : Teramo, San Nicolo A Tord...

    State :

    Country/Area : Italy

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    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2022-04-08

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2021-12-03

    ACS DOBFAR SPA

    City : Tribiano

    State :

    Country/Area : Italy

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2021-12-03

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    FDA Audited

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2021-07-16

    ACS DOBFAR SPA

    City : Tribiano

    State :

    Country/Area : Italy

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2021-07-16

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    FDA Audited

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-12-13

    ACS DOBFAR SPA

    City : Anagni

    State :

    Country/Area : Italy

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-12-13

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    FDA Audited

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-04-19

    ACS DOBFAR SPA

    City : Verona

    State :

    Country/Area : Italy

    Zip :

    District :

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    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-04-19

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    GMP Certified

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    Antibioticos do Brasil Ltda

    Type : GMP Non-Compliance

    Number : IT/GMP/E/1-...

    EudraGMDP Key : 39861

    Country : Brazil

    Issue Date : 2017-01-05

    Post Code : 13150-000

    NCA Ref : 200410

    City : Bairro Itapavussu, Cosm...

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    GMP Certified

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    ACS DOBFAR SPA

    Type : GMP Certificates

    Number : IT/193/H/20...

    EudraGMDP Key : 37051

    Country : Italy

    Issue Date : 2016-08-12

    Post Code : 64100

    NCA Ref : 8901

    City : TERAMO

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    ACS DOBFAR SPA

    Type : GMP Certificates

    Number : NBF/38/2016...

    EudraGMDP Key : 38915

    Country : Italy

    Issue Date : 2016-07-25

    Post Code : 20871

    NCA Ref : 295

    City : VIMERCATE (Monza-Brianz...

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    ACS DOBFAR SPA

    Type : GMP Certificates

    Number : NBF/34/2016...

    EudraGMDP Key : 38963

    Country : Italy

    Issue Date : 2016-07-11

    Post Code : 00071

    NCA Ref : 314

    City : POMEZIA (RM)

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    ACS DOBFAR SPA

    Type : GMP Certificates

    Number : IT/API/M/02...

    EudraGMDP Key : 35417

    Country : Italy

    Issue Date : 2016-05-27

    Post Code : 24061

    NCA Ref : 000000000010

    City : ALBANO SANT\'ALESSANDRO

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    06

    GMP Certified

    EU
    PEGS Boston Summit
    Not Confirmed
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    GMP Certified

    EU
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    PEGS Boston Summit
    Not Confirmed

    ACS DOBFAR SPA

    Type : GMP Certificates

    Number : IT/285/H/20...

    EudraGMDP Key : 32695

    Country : Italy

    Issue Date : 2015-12-15

    Post Code : 20067

    NCA Ref : 8056

    City : TRIBIANO

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    07

    GMP Certified

    EU
    PEGS Boston Summit
    Not Confirmed
    arrow

    GMP Certified

    EU
    arrow
    PEGS Boston Summit
    Not Confirmed

    ACS DOBFAR SPA

    Type : GMP Certificates

    Number : IT-API/95/H...

    EudraGMDP Key : 30773

    Country : Italy

    Issue Date : 2015-08-25

    Post Code : 20067

    NCA Ref : 100057

    City : TRIBIANO

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    08

    GMP Certified

    EU
    PEGS Boston Summit
    Not Confirmed
    arrow

    GMP Certified

    EU
    arrow
    PEGS Boston Summit
    Not Confirmed

    ACS DOBFAR SPA

    Type : GMP Certificates

    Number : NBF/37/2015...

    EudraGMDP Key : 29959

    Country : Italy

    Issue Date : 2015-06-12

    Post Code : 20067

    NCA Ref : 143

    City : TRIBIANO (MI)

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    09

    GMP Certified

    EU
    PEGS Boston Summit
    Not Confirmed
    arrow

    GMP Certified

    EU
    arrow
    PEGS Boston Summit
    Not Confirmed

    ACS DOBFAR SPA

    Type : GMP Certificates

    Number : NBF/35/2015...

    EudraGMDP Key : 29789

    Country : Italy

    Issue Date : 2015-06-05

    Post Code : 20067

    NCA Ref : 9280

    City : TRIBIANO ( MI)

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    10

    GMP Certified

    EU
    PEGS Boston Summit
    Not Confirmed
    arrow

    GMP Certified

    EU
    arrow
    PEGS Boston Summit
    Not Confirmed

    ACS DOBFAR SPA

    Type : GMP Certificates

    Number : NBF/33/2015...

    EudraGMDP Key : 29514

    Country : Italy

    Issue Date : 2015-05-22

    Post Code : 64020

    NCA Ref : 298

    City : TERAMO

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    Contact ACS DOBFAR and get a quotation

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

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