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    Company profile for ZACH System SA

    ZACH System-PSE
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    Zambon Launches Intravenous Formulation of Fluimucil

    29 Jun 2025

    // PRESS RELEASE

    Massimo Grandi joins Zambon as Chief Core Therapies Officer 

    26 Feb 2025

    // PRESS RELEASE

    Zambon Ventures Leads C$2 million investment In Health Innovation

    24 Sep 2024

    // PRESS RELEASE

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    About

    Zach System, a subsidiary of Zambon Company, specializes in providing active pharmaceutical ingredients (APIs), intermediates and custom synthesis services that align with customers’ schedules and budget targets. It offers a diverse range of products and services for the generic drugs market, including producing APIs for Zambon Pharma and offering process development expertise to customers. Its facility in Avrillè, France, is cGMP compliant and approved by the FDA. The facility boasts reactors ranging from 50 litres to 10,000 litres, advanced technologies, and a state-of-the-art R&D center and QC labs, as well as a dedicated sales team.

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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
    Client Website
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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 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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    Zambon Phase 3 Study Shows Success In CMS I-neb Efficacy In NCFB
    Zambon Phase 3 Study Shows Success In CMS I-neb Efficacy In NCFB

    13 Sep 2024

    // PRESS RELEASE

    https://www.zambon.com/sites/default/files/press/files/2024-09/240913_global_zambon_lancet-promis-1.pdf

    PRESS RELEASE
    13 Sep 2024
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    Giovanni Magnaghi is the new Chief Executive Officer of Zambon SpA
    Giovanni Magnaghi is the new Chief Executive Officer of Zambon SpA

    02 May 2024

    // PRESS RELEASE

    https://www.zambon.com/en/media/press/2024-05-02-giovanni-magnaghi-new-chief-executive-officer-zambon-spa

    PRESS RELEASE
    02 May 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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    ChemOutsourcing
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothZach System is committed to providing Highly Customized Solutions for all your Development Programs.
    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
    ✖
    Available Reg. Filing : ASMF
    AUDIT
    Zach System VB Company banner

    Product
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    Stock Recap
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    02

    Loteprednol Etabonate

    France

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

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    ChemOutsourcing
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothZach System is committed to providing Highly Customized Solutions for all your Development Programs.
    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 : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : BASH HEALTH KOREA CORP.

    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
    ✖
    Available Reg. Filing : ASMF
    AUDIT
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    03

    Trimebutine Maleate

    France

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

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    ChemOutsourcing
    Exhibiting
    • 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
    ✖
    Available Reg. Filing : ASMF
    AUDIT
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    04

    Trimebutine Maleate

    France

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

    arrow
    ChemOutsourcing
    Exhibiting
    • 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 : 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
    ✖
    Available Reg. Filing : ASMF
    AUDIT
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    KDMF

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    01

    Loteprednol etaboate

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

    ZACH System SA

    Registrant Name : BASH HEALTH KOREA CORP.

    Registration Date : 2008-05-07

    Registration Number : 4063-1-ND

    Manufacturer Name : Zach system

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

    Zach System VB Company banner

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    #Pipeline Prospector

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    02

    Trimebutine

    France
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    ChemOutsourcing
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP
    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 : 2011-03-31

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

    Manufacturer Name : ZACH SYSTEM

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

    Zach System VB Company banner

    Product
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    #Pipeline Prospector

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    03

    Trimebutine maleate

    France
    arrow
    ChemOutsourcing
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP
    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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    Zach System, a subsidiary of Zambon Company, specializes in providing active pharmaceutical ingredients (APIs), intermediates and custom synthesis services that align with customers’ schedules and budget targets. It offers a diverse range of products and services for the generic drugs market, including producing APIs for Zambon Pharma and offerin...
    Zach System, a subsidiary of Zambon Company, specializes in providing active pharmaceutical ingredients (APIs), intermediates and custom synthesis services that align with customers’ schedules and budget targets. It offers a diverse range of products and services for the generic drugs market, including producing APIs for Zambon Pharma and offering process development expertise to customers. Its facility in Avrillè, France, is cGMP compliant and approved by the FDA. The facility boasts reactors ranging from 50 litres to 10,000 litres, advanced technologies, and a state-of-the-art R&D center and QC labs, as well as a dedicated sales team.
    Zach System VB Company banner

    01

    Bosentan Hydrate

    France
    arrow
    ChemOutsourcing
    Exhibiting
    • 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, specializes in providing active pharmaceutical ingredients (APIs), intermediates and custom synthesis services that align with customers’ schedules and budget targets. It offers a diverse range of products and services for the generic drugs market, including producing APIs for Zambon Pharma and offering process development expertise to customers. Its facility in Avrillè, France, is cGMP compliant and approved by the FDA. The facility boasts reactors ranging from 50 litres to 10,000 litres, advanced technologies, and a state-of-the-art R&D center and QC labs, as well as a dedicated sales team.

    About the Company : Zach System, a subsidiary of Zambon Company, specializes in providing active pharmaceutical ingredients (APIs), intermediates and custom synthesis services that align with customers’ schedules...

    Zach System VB Company banner

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

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

    Loteprednol Etabonate

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    Zach System, a subsidiary of Zambon Company, specializes in providing active pharmaceutical ingredients (APIs), intermediates and custom synthesis services that align with customers’ schedules and budget targets. It offers a diverse range of products and services for the generic drugs market, including producing APIs for Zambon Pharma and offerin...
    Zach System, a subsidiary of Zambon Company, specializes in providing active pharmaceutical ingredients (APIs), intermediates and custom synthesis services that align with customers’ schedules and budget targets. It offers a diverse range of products and services for the generic drugs market, including producing APIs for Zambon Pharma and offering process development expertise to customers. Its facility in Avrillè, France, is cGMP compliant and approved by the FDA. The facility boasts reactors ranging from 50 litres to 10,000 litres, advanced technologies, and a state-of-the-art R&D center and QC labs, as well as a dedicated sales team.
    Zach System VB Company banner

    02

    Loteprednol Etabonate

    France
    arrow
    ChemOutsourcing
    Exhibiting
    • 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, specializes in providing active pharmaceutical ingredients (APIs), intermediates and custom synthesis services that align with customers’ schedules and budget targets. It offers a diverse range of products and services for the generic drugs market, including producing APIs for Zambon Pharma and offering process development expertise to customers. Its facility in Avrillè, France, is cGMP compliant and approved by the FDA. The facility boasts reactors ranging from 50 litres to 10,000 litres, advanced technologies, and a state-of-the-art R&D center and QC labs, as well as a dedicated sales team.

    About the Company : Zach System, a subsidiary of Zambon Company, specializes in providing active pharmaceutical ingredients (APIs), intermediates and custom synthesis services that align with customers’ schedules...

    Zach System VB Company banner

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

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

    Trimebutine Maleate

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    Zach System, a subsidiary of Zambon Company, specializes in providing active pharmaceutical ingredients (APIs), intermediates and custom synthesis services that align with customers’ schedules and budget targets. It offers a diverse range of products and services for the generic drugs market, including producing APIs for Zambon Pharma and offerin...
    Zach System, a subsidiary of Zambon Company, specializes in providing active pharmaceutical ingredients (APIs), intermediates and custom synthesis services that align with customers’ schedules and budget targets. It offers a diverse range of products and services for the generic drugs market, including producing APIs for Zambon Pharma and offering process development expertise to customers. Its facility in Avrillè, France, is cGMP compliant and approved by the FDA. The facility boasts reactors ranging from 50 litres to 10,000 litres, advanced technologies, and a state-of-the-art R&D center and QC labs, as well as a dedicated sales team.
    Zach System VB Company banner

    03

    Trimebutine Maleate

    France
    arrow
    ChemOutsourcing
    Exhibiting
    • 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, specializes in providing active pharmaceutical ingredients (APIs), intermediates and custom synthesis services that align with customers’ schedules and budget targets. It offers a diverse range of products and services for the generic drugs market, including producing APIs for Zambon Pharma and offering process development expertise to customers. Its facility in Avrillè, France, is cGMP compliant and approved by the FDA. The facility boasts reactors ranging from 50 litres to 10,000 litres, advanced technologies, and a state-of-the-art R&D center and QC labs, as well as a dedicated sales team.

    About the Company : Zach System, a subsidiary of Zambon Company, specializes in providing active pharmaceutical ingredients (APIs), intermediates and custom synthesis services that align with customers’ schedules...

    Zach System VB Company banner

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    KEY PRODUCTS

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    Services

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    Analytical

    Discover their expertise for : Analytical

    API Manufacturing

    Discover their expertise for : API Manufacturing

    Organometallic Chemistry

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    01

    CYANATION FOR API CUSTOM SYNTHESIS

    France
    Contact Supplier
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    ChemOutsourcing
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP

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

    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

    • fda
    • EDQM
    • WHO-GMP

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

    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
    Contact Supplier
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    ChemOutsourcing
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP

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

    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.

    arrow

    Category : Organometallic Chemistry

    Sub Category : Metal Hydride Reduction

    • fda
    • EDQM
    • WHO-GMP

    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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    #ServicesBio

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    KEY SERVICES

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    TOP RANKED SUPPLIER FOR:

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    TOP RANKED SUPPLIER FOR:

    Large Scale cGMP API Spray Drying
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    Cyanation & Metal Hydride Reduction Services
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    Metal Hydride Reaction Services
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    Ozonolysis Reactions
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    Ultrafiltration & Nanofiltration
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    Inspections and registrations

    Check the inspections & registration from this company

    FDA

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    01

    FDA Audited

    USA
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    Exhibiting

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-12-07

    ZACH System SA

    City : Avrille Cedex

    State :

    Country/Area : France

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-12-07

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    02

    FDA Audited

    USA
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    ChemOutsourcing
    Exhibiting

    District Decision : No Action Indicated

    Inspection End Date : 2014-10-16

    ZACH System SA

    City : Avrille Cedex

    State :

    Country/Area : France

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-10-16

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    03

    FDA Audited

    USA
    arrow
    ChemOutsourcing
    Exhibiting

    District Decision : No Action Indicated

    Inspection End Date : 2010-12-02

    ZACH System SA

    City : Avrille Cedex

    State :

    Country/Area : France

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2010-12-02

    Zach System VB Company banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    EDQM

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    01

    GMP Certified

    EU
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    Exhibiting

    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

    EU
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    Exhibiting

    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

    EU
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    Exhibiting

    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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    04

    GMP Certified

    EU
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    ChemOutsourcing
    Exhibiting

    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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    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

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    Exhibiting

    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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    Exhibiting

    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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    Exhibiting

    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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    Exhibiting

    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

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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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    GDUFA fees paid

    USA
    arrow
    ChemOutsourcing
    Exhibiting
    • 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

    Contact ZACH System SA and get a quotation

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

    Find a price of Bosentan Hydrate bulk with DMF offered by ZACH System SA

    Find a price of Loteprednol Etabonate bulk with DMF offered by ZACH System SA

    Find a price of Trimebutine Maleate bulk offered by ZACH System SA

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