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    Company profile for ZACH System SA

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    Zambon Announce First patient dosed in Ph 3b ADIP study of IPX203

    22 Dec 2025

    // PRESS RELEASE

    Zambon appoints Franco Gaudino as Chief HR Officer

    11 Sep 2025

    // PRESS RELEASE

    Zambon Launches Intravenous Formulation of Fluimucil

    29 Jun 2025

    // PRESS RELEASE

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    About

    Zach System, a subsidiary of Zambon Company, provides Active Pharmaceutical Ingredients (APIs), intermediates, and custom synthesis services aligned with customer timelines and budgets. The company serves the generic drugs market, producing APIs for Zambon Pharma and offering process development expertise. Its cGMP-compliant facility in Avrillè, France, is FDA approved and equipped with reactors from 50 to 10,000 litres, advanced technologies, and integrated R&D and QC laboratories. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

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    ZACH System SAFrance Flag
    Country
    Country
    France
    Address
    Address
    Z.l. la Croix Cadeau C.S 10079 49242 Avrille Cedex
    Telephone
    Telephone
    +33 676065210
    Client Email
    Email
    nicolas.girard@zambongroup.com
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    https://www.zambon.com/en/production/zach-system
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    https://x.com/zambonpharma
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    Product List 2024

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    Corporate Presentation

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    Results of Phase 3 PROMIS-I & PROMIS-II Studies 2023

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    GMP Certificate 2023

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    Zach Digital Brochure

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    Sophisticated Molecules

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    NEWS #PharmaBuzz

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    Zambon Announce First patient dosed in Ph 3b ADIP study of IPX203
    Zambon Announce First patient dosed in Ph 3b ADIP study of IPX203

    22 Dec 2025

    // PRESS RELEASE

    https://www.zambon.com/en/media/press/2025-12-22-zambon-biotech-announces-first-patient-dosed-phase-3b-adip-clinical-study

    PRESS RELEASE
    22 Dec 2025
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    Zambon appoints Franco Gaudino as Chief HR Officer
    Zambon appoints Franco Gaudino as Chief HR Officer

    11 Sep 2025

    // PRESS RELEASE

    https://www.zambon.com/en/media/press/2025-09-11-zambon-appoints-franco-gaudino-chief-hr-officer

    PRESS RELEASE
    11 Sep 2025
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    Zambon Launches Intravenous Formulation of Fluimucil
    Zambon Launches Intravenous Formulation of Fluimucil

    29 Jun 2025

    // PRESS RELEASE

    https://www.zambon.com/en/media/press/2025-06-24-zambon-announces-approval-and-launch-china-intravenous-formulation

    PRESS RELEASE
    29 Jun 2025
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    Massimo Grandi joins Zambon as Chief Core Therapies Officer 
    Massimo Grandi joins Zambon as Chief Core Therapies Officer 

    26 Feb 2025

    // PRESS RELEASE

    https://www.zambon.com/en/media/press/2025-02-26-massimo-grandi-joins-zambon-chief-core-therapies-officer

    PRESS RELEASE
    26 Feb 2025
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    Zambon Ventures Leads C$2 million investment In Health Innovation
    Zambon Ventures Leads C$2 million investment In Health Innovation

    24 Sep 2024

    // PRESS RELEASE

    https://www.zambon.com/en/media/press/2024-09-24-zcube-zambon-research-venture-leads-c2-million-investment-round-canadian

    PRESS RELEASE
    24 Sep 2024
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    Zcube Announces 5 Startups For New Edition Focused Women's Health
    Zcube Announces 5 Startups For New Edition Focused Women's Health

    23 Sep 2024

    // PRESS RELEASE

    https://www.zambon.com/sites/default/files/press/files/2024-09/open-accelerator-announces-5-startups-2024-program.pdf

    PRESS RELEASE
    23 Sep 2024
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    ALL APIs

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    01

    Bosentan Hydrate

    France

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

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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-08-25

    Pay. Date : 2014-01-31

    DMF Number : 24929

    Submission : 2011-05-09

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF ASMF arrow-down
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    Available Reg. Filing : ASMF
    AUDIT
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    02

    Loteprednol Etabonate

    France

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

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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2024-10-16

    Pay. Date : 2024-10-08

    DMF Number : 11105

    Submission : 1994-09-26

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 60269-287

    Start Marketing Date : 1998-03-09

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Bausch Health Korea Co., Ltd.

    Registration Date : 2008-05-07

    Registration Number : 4063-1-ND

    Manufacturer Name : Zach system

    Manufacturer Address : Zone Industrielle La Croix Cadeau Avrille, 49240, France

     VMF ASMF arrow-down
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    Available Reg. Filing : ASMF
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    03

    Trimebutine Maleate

    France

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

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    USDMF CEP/COS JDMF EU-WC NDC KDMF arrow-down
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    Registrant Name : Samil Pharmaceutical Co., Ltd.

    Registration Date : 2005-08-31

    Registration Number : 20050831-13-B-55-02

    Manufacturer Name : ZACH SYSTEM

    Manufacturer Address : ZI La Corix Cadeau, 49240 Avrille, France

     VMF ASMF arrow-down
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    Available Reg. Filing : ASMF
    AUDIT
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    04

    Trimebutine Maleate

    France

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

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    Biotech Outsourcing Strategies
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    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothZach System is committed to providing Highly Customized Solutions for all your Development Programs.
    USDMF CEP/COS JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Samil Pharmaceutical Co., Ltd.

    Registration Date : 2011-03-31

    Registration Number : 20110331-13-B-310-07

    Manufacturer Name : ZACH SYSTEM

    Manufacturer Address : ZI La Corix Cadeau, 49240 Avrille, France

     VMF ASMF arrow-down
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    Available Reg. Filing : ASMF
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    KDMF

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    01

    Roteprednol etaboate

    France
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    ZACH System SA

    Registrant Name : Bausch Health Korea Co., Ltd.

    Registration Date : 2008-05-07

    Registration Number : 4063-1-ND

    Manufacturer Name : Zach system

    Manufacturer Address : Zone Industrielle La Croix Cadeau Avrille, 49240, France

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    02

    Trimebutin

    France
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    ZACH System SA

    Registrant Name : Samil Pharmaceutical Co., Ltd.

    Registration Date : 2011-03-31

    Registration Number : 20110331-13-B-310-07

    Manufacturer Name : ZACH SYSTEM

    Manufacturer Address : ZI La Corix Cadeau, 49240 Avrille, France

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    03

    Trimebutine maleate

    France
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    Virtual BoothZach System is committed to providing Highly Customized Solutions for all your Development Programs.

    ZACH System SA

    Registrant Name : Samil Pharmaceutical Co., Ltd.

    Registration Date : 2005-08-31

    Registration Number : 20050831-13-B-55-02

    Manufacturer Name : ZACH SYSTEM

    Manufacturer Address : ZI La Corix Cadeau, 49240 Avrille, France

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    LISTED APIs

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    Bosentan Hydrate

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    Zach System, a subsidiary of Zambon Company, provides Active Pharmaceutical Ingredients (APIs), intermediates, and custom synthesis services aligned with customer timelines and budgets. The company serves the generic drugs market, producing APIs for Zambon Pharma and offering process development expertise. Its cGMP-compliant facility in Avrill&egra...
    Zach System, a subsidiary of Zambon Company, provides Active Pharmaceutical Ingredients (APIs), intermediates, and custom synthesis services aligned with customer timelines and budgets. The company serves the generic drugs market, producing APIs for Zambon Pharma and offering process development expertise. Its cGMP-compliant facility in Avrillè, France, is FDA approved and equipped with reactors from 50 to 10,000 litres, advanced technologies, and integrated R&D and QC laboratories. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Zach System VB Company banner

    01

    Bosentan Hydrate

    France
    arrow
    Biotech Outsourcing Strategies
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothZach System is committed to providing Highly Customized Solutions for all your Development Programs.

    ZACH System SA

    Zach System, a subsidiary of Zambon Company, provides Active Pharmaceutical Ingredients (APIs), intermediates, and custom synthesis services aligned with customer timelines and budgets. The company serves the generic drugs market, producing APIs for Zambon Pharma and offering process development expertise. Its cGMP-compliant facility in Avrillè, France, is FDA approved and equipped with reactors from 50 to 10,000 litres, advanced technologies, and integrated R&D and QC laboratories. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : Zach System, a subsidiary of Zambon Company, provides Active Pharmaceutical Ingredients (APIs), intermediates, and custom synthesis services aligned with customer timelines and budgets. The comp...

    Zach System VB Company banner

    Product
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    Stock Recap
    #Pipeline Prospector

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    • FDA
    • EDQM
    • fda
    • EDQM
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    Virtual BoothZach System is committed to providing Highly Customized Solutions for all your Development Programs.

    Loteprednol Etabonate

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    Market
    Place

    Zach System, a subsidiary of Zambon Company, provides Active Pharmaceutical Ingredients (APIs), intermediates, and custom synthesis services aligned with customer timelines and budgets. The company serves the generic drugs market, producing APIs for Zambon Pharma and offering process development expertise. Its cGMP-compliant facility in Avrill&egra...
    Zach System, a subsidiary of Zambon Company, provides Active Pharmaceutical Ingredients (APIs), intermediates, and custom synthesis services aligned with customer timelines and budgets. The company serves the generic drugs market, producing APIs for Zambon Pharma and offering process development expertise. Its cGMP-compliant facility in Avrillè, France, is FDA approved and equipped with reactors from 50 to 10,000 litres, advanced technologies, and integrated R&D and QC laboratories. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Zach System VB Company banner

    02

    Loteprednol Etabonate

    France
    arrow
    Biotech Outsourcing Strategies
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothZach System is committed to providing Highly Customized Solutions for all your Development Programs.

    ZACH System SA

    Zach System, a subsidiary of Zambon Company, provides Active Pharmaceutical Ingredients (APIs), intermediates, and custom synthesis services aligned with customer timelines and budgets. The company serves the generic drugs market, producing APIs for Zambon Pharma and offering process development expertise. Its cGMP-compliant facility in Avrillè, France, is FDA approved and equipped with reactors from 50 to 10,000 litres, advanced technologies, and integrated R&D and QC laboratories. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : Zach System, a subsidiary of Zambon Company, provides Active Pharmaceutical Ingredients (APIs), intermediates, and custom synthesis services aligned with customer timelines and budgets. The comp...

    Zach System VB Company banner

    Product
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    Stock Recap
    #Pipeline Prospector

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    Contact Supplier
    • FDA
    • EDQM
    • fda
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    Virtual BoothZach System is committed to providing Highly Customized Solutions for all your Development Programs.

    Trimebutine Maleate

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    Stock Recap
    #PipelineProspector

    Market
    Place

    Zach System, a subsidiary of Zambon Company, provides Active Pharmaceutical Ingredients (APIs), intermediates, and custom synthesis services aligned with customer timelines and budgets. The company serves the generic drugs market, producing APIs for Zambon Pharma and offering process development expertise. Its cGMP-compliant facility in Avrill&egra...
    Zach System, a subsidiary of Zambon Company, provides Active Pharmaceutical Ingredients (APIs), intermediates, and custom synthesis services aligned with customer timelines and budgets. The company serves the generic drugs market, producing APIs for Zambon Pharma and offering process development expertise. Its cGMP-compliant facility in Avrillè, France, is FDA approved and equipped with reactors from 50 to 10,000 litres, advanced technologies, and integrated R&D and QC laboratories. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Zach System VB Company banner

    03

    Trimebutine Maleate

    France
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    Biotech Outsourcing Strategies
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothZach System is committed to providing Highly Customized Solutions for all your Development Programs.

    ZACH System SA

    Zach System, a subsidiary of Zambon Company, provides Active Pharmaceutical Ingredients (APIs), intermediates, and custom synthesis services aligned with customer timelines and budgets. The company serves the generic drugs market, producing APIs for Zambon Pharma and offering process development expertise. Its cGMP-compliant facility in Avrillè, France, is FDA approved and equipped with reactors from 50 to 10,000 litres, advanced technologies, and integrated R&D and QC laboratories. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : Zach System, a subsidiary of Zambon Company, provides Active Pharmaceutical Ingredients (APIs), intermediates, and custom synthesis services aligned with customer timelines and budgets. The comp...

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    KEY PRODUCTS

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    Services

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    Analytical

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    API Manufacturing

    Discover their expertise for : API Manufacturing

    Organometallic Chemistry

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    01

    CYANATION FOR API CUSTOM SYNTHESIS

    France
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    Pharma Service : API Manufacturing

    ZACH System SA

    Zach provides custom API synthesis services for active pharmaceutical ingredients (APIs) & quality intermediates involving cyanation of alkali metal cyanides & substitutes, asymmetric synthesis, metal hydride reduction, amino acids derivatization, etc.

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    Category : Organometallic Chemistry

    Sub Category : Cyanation

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    Pharma Service : API Manufacturing

    CYANATION FOR API CUSTOM SYNTHESIS

    Zach provides custom API synthesis services for active pharmaceutical ingredients (APIs) & quality intermediates involving cyanation of alkali metal cyanides & substitutes, asymmetric synthesis, metal hydride reduction, amino acids derivatization, etc.

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    Zach Cyanation for API Custom Synthesis

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    02

    METAL HYDRIDE REDUCTION

    France
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    Pharma Service : API Manufacturing

    ZACH System SA

    Zach provides custom API synthesis services for active pharmaceutical ingredients & quality intermediates involving metal hydride reduction (powder & solutions using reducing agents like LAH, DIBAL, LiAl(O-tBu)3H, NaBH4), asymmetric synthesis & cyanation.

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    Category : Organometallic Chemistry

    Sub Category : Metal Hydride Reduction

    • fda
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    Virtual BoothZach System is committed to providing Highly Customized Solutions for all your Development Programs.

    Pharma Service : API Manufacturing

    METAL HYDRIDE REDUCTION

    Zach provides custom API synthesis services for active pharmaceutical ingredients & quality intermediates involving metal hydride reduction (powder & solutions using reducing agents like LAH, DIBAL, LiAl(O-tBu)3H, NaBH4), asymmetric synthesis & cyanation.

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    Zech Metal Hydride Reduction

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    KEY SERVICES

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    HPAPIs Spray Drying
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    Inspections and registrations

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    ZACH System

    FDA

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    01

    FDA Audited

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2021-02-12

    ZACH System SA

    City : Avrille Cedex

    State :

    Country/Area : France

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2021-02-12

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    02

    FDA Audited

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-12-07

    ZACH System SA

    City : Avrille Cedex

    State :

    Country/Area : France

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-12-07

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    03

    FDA Audited

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    District Decision : No Action Indicated

    Inspection End Date : 2014-10-16

    ZACH System SA

    City : Avrille Cedex

    State :

    Country/Area : France

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-10-16

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    04

    FDA Audited

    USA
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    District Decision : No Action Indicated

    Inspection End Date : 2010-12-02

    ZACH System SA

    City : Avrille Cedex

    State :

    Country/Area : France

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2010-12-02

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    05

    FDA Audited

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    District Decision : Official Action Indicated

    Inspection End Date : 2009-06-11

    ZACH System SA

    City : Avrille Cedex

    State :

    Country/Area : France

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Official Action Indicated

    Inspection End Date : 2009-06-11

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    EDQM

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    GMP Certified

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    ZACH System SA

    Type : GMP Certificates

    Number : 21MPP009VFR...

    EudraGMDP Key : 163748

    Country : France

    Issue Date : 2023-09-14

    Post Code :

    NCA Ref : 413 581 034 ...

    City : Avrille

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    02

    GMP Certified

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    ZACH System SA

    Type : GMP Certificates

    Number : 21MPP009HFR...

    EudraGMDP Key : 163268

    Country : France

    Issue Date : 2023-08-28

    Post Code :

    NCA Ref : 413 581 034 ...

    City : Avrille

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    03

    GMP Certified

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    ZACH System SA

    Type : GMP Certificates

    Number : 21MPP009HFR...

    EudraGMDP Key : 126703

    Country : France

    Issue Date : 2021-04-28

    Post Code :

    NCA Ref : 413581034000...

    City : Avrille

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    04

    GMP Certified

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    ZACH System SA

    Type : GMP Certificates

    Number : 21MPP009VFR...

    EudraGMDP Key : 126702

    Country : France

    Issue Date : 2021-04-28

    Post Code :

    NCA Ref : 413581034000...

    City : Avrille

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    05

    GMP Certified

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    ZACH System SA

    Type : GMP Certificates

    Number : 17MPP087HVF...

    EudraGMDP Key : 46146

    Country : France

    Issue Date : 2018-01-30

    Post Code :

    NCA Ref : 413581034000...

    City : Avrille

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    06

    GMP Certified

    EU
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    Attending

    ZACH System SA

    Type : GMP Certificates

    Number : 17MPP087VFR...

    EudraGMDP Key : 46182

    Country : France

    Issue Date : 2018-01-30

    Post Code :

    NCA Ref : 413581034000...

    City : Avrille

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    07

    GMP Certified

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    ZACH System SA

    Type : GMP Certificates

    Number : HMP/FR/25/2...

    EudraGMDP Key : 41195

    Country : France

    Issue Date : 2015-04-04

    Post Code :

    NCA Ref : 413581034000...

    City : Avrille

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    08

    GMP Certified

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    ZACH System SA

    Type : GMP Certificates

    Number : HMP/FR/28/2...

    EudraGMDP Key : 15043

    Country : France

    Issue Date : 2012-03-19

    Post Code :

    NCA Ref : 413 581 034 ...

    City : Avrille

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    09

    GMP Certified

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    ZACH System SA

    Type : GMP Certificates

    Number : HMP/FR/94/2...

    EudraGMDP Key : 3477

    Country : France

    Issue Date : 2009-05-18

    Post Code :

    NCA Ref : A064 9415 91...

    City : Avrille

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    10

    GMP Certified

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    ZACH System SA

    Type : GMP Certificates

    Number : VMP/FR/7/20...

    EudraGMDP Key : 6511

    Country : France

    Issue Date : 2009-05-18

    Post Code :

    NCA Ref : A064 9415 91...

    City : Avrille

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    GDUFA fees paid

    USA
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    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothZach System is committed to providing Highly Customized Solutions for all your Development Programs.

    Paid in : 2025

    ZACH System SA

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : ZACH SYSTEM S.A.

    Business Address : ZONE INDUSTRIELLE CROIX CADE...

    FEI Number : 3002808164

    Country : France

    Paid in : 2025

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    02

    GDUFA fees paid

    USA
    arrow
    Biotech Outsourcing Strategies
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothZach System is committed to providing Highly Customized Solutions for all your Development Programs.

    Paid in : 2017

    ZACH System SA

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : Zach System S.p.A.

    Business Address : Via Dovaro Lonigo Vicenza 36...

    FEI Number : 3002808541

    Country : France

    Paid in : 2017

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    ABOUT THIS PAGE

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    ZACH System SA is a supplier offers 3 products (APIs, Excipients or Intermediates).

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