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    Details of Minakem's U.S. FDA Inspections. Original Data: FDA Inspection Database

    Client Virtual Booth

    MINAKEM

    EVENTS

    • Webinars & Exhibitions

    PRESENTATION(s)

    VIDEO(s)

    DIGITAL CONTENT

    APIs // Active Pharmaceutical Ingredients

    DEVELOPMENTS

    Key Products KEY PRODUCTS

    • 1,1-Cyclobutane Dicarboxylic Acid

    • Budesonide

    • Cyclobutane Carboxaldehyde

    • Cyclopropyl Methyl Bromide

    • Cyclopropyl Methyl Chloride

    • Esomeprazole Magnesium

    • Esomeprazole Sodium

    • Fulvestrant

    • Ibrutinib

    • Methyl (1R,2S,5S)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxylate HCl

    • Propyl Gallate

    • Remifentanil

    • Vinblastine Sulfate

    • Vincristine Sulfate

    • Vinorelbine Tartrate

    INTERMEDIATES

    SERVICES

    Key Products KEY SERVICES

    • Continuous Flow Chemistry

    • Synthesis of Advanced Intermediates

    • Polymorph, Salt & Cocrystal Study

    • API Custom Synthesis

    • CDMO for High Potency APIs (HPAPIs)

    • HPAPI Contract Manufacturing

    EXCIPIENTS

    Key Products KEY EXCIPIENTS

    • Propyl Gallate GMP

    EXCIPIENTS BY INGREDIENTS

    EXCIPIENTS BY APPLICATIONS

    INSPECTIONS & REGISTRATIONS

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    Minakem RM
    Minakem
    France Flag
    Country
    Country
    France
    Address
    Address
    224 Avenue de la Dordogne, 59640 Dunkerque
    Telephone
    Telephone
    +33 320646830
    Client Email
    Email
    contact@minakem.com
    Client Website
    Website
    https://minakem.com/
    Linkedin
    Linkedin
    https://www.linkedin.com/company/minakem
    Twitter
    Twitter
    https://twitter.com/Minafin_Group
    Contact Info
    Others

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    product-page Supplier Virtual Booth
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    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    INSPECTIONS & REGISTRATIONS

    PDF Supplier PDF
    URL Supplier Web Content
    Voluntary Action Indicated
    2020-02-06
    Corbais
    BE
    ORA
    CDER
    Drug Quality Assurance
    Minakem Comapny Banner

    CPhI Japan

    Booth #5G-04

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    INSPECTIONS & REGISTRATIONS

    PDF Supplier PDF
    URL Supplier Web Content
    Voluntary Action Indicated
    2018-06-22
    Dunkirk
    FR
    ORA
    CDER
    Drug Quality Assurance
    Minakem Comapny Banner

    CPhI Japan

    Booth #5G-04

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    INSPECTIONS & REGISTRATIONS

    PDF Supplier PDF
    URL Supplier Web Content
    Voluntary Action Indicated
    2018-01-25
    Beuvry-la-foret
    FR
    ORA
    CDER
    Drug Quality Assurance
    Minakem Comapny Banner

    CPhI Japan

    Booth #5G-04

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    INSPECTIONS & REGISTRATIONS

    PDF Supplier PDF
    URL Supplier Web Content
    Voluntary Action Indicated
    2016-04-22
    Dunkirk
    FR
    ORA
    CDER
    Drug Quality Assurance
    Minakem Comapny Banner

    CPhI Japan

    Booth #5G-04

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    INSPECTIONS & REGISTRATIONS

    PDF Supplier PDF
    URL Supplier Web Content
    Voluntary Action Indicated
    2016-03-25
    Beuvry-la-foret
    FR
    ORA
    CVM
    Monitoring of Marketed An...
    Minakem Comapny Banner

    CPhI Japan

    Booth #5G-04

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    INSPECTIONS & REGISTRATIONS

    PDF Supplier PDF
    URL Supplier Web Content
    Voluntary Action Indicated
    2016-03-25
    Beuvry-la-foret
    FR
    ORA
    CDER
    Drug Quality Assurance
    Minakem Comapny Banner

    CPhI Japan

    Booth #5G-04

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    INSPECTIONS & REGISTRATIONS

    PDF Supplier PDF
    URL Supplier Web Content
    No Action Indicated
    2015-09-24
    Corbais
    BE
    ORA
    CDER
    Drug Quality Assurance
    Minakem Comapny Banner

    CPhI Japan

    Booth #5G-04

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    INSPECTIONS & REGISTRATIONS

    PDF Supplier PDF
    URL Supplier Web Content
    Voluntary Action Indicated
    2013-09-13
    Beuvry-la-foret
    FR
    ORA
    CVM
    Monitoring of Marketed An...
    Minakem Comapny Banner

    CPhI Japan

    Booth #5G-04

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    INSPECTIONS & REGISTRATIONS

    PDF Supplier PDF
    URL Supplier Web Content
    Voluntary Action Indicated
    2013-09-13
    Beuvry-la-foret
    FR
    ORA
    CDER
    Drug Quality Assurance
    Minakem Comapny Banner

    CPhI Japan

    Booth #5G-04

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    INSPECTIONS & REGISTRATIONS

    PDF Supplier PDF
    URL Supplier Web Content
    No Action Indicated
    2013-05-17
    Dunkirk
    FR
    ORA
    CDER
    Drug Quality Assurance
    Minakem Comapny Banner

    CPhI Japan

    Booth #5G-04

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    INSPECTIONS & REGISTRATIONS

    PDF Supplier PDF
    URL Supplier Web Content
    Voluntary Action Indicated
    2012-01-12
    Corbais
    BE
    ORA
    CDER
    Drug Quality Assurance
    Minakem Comapny Banner

    CPhI Japan

    Booth #5G-04

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    INSPECTIONS & REGISTRATIONS

    PDF Supplier PDF
    URL Supplier Web Content
    Voluntary Action Indicated
    2010-07-08
    Beuvry-la-foret
    FR
    ORA
    CVM
    Monitoring of Marketed An...
    Minakem Comapny Banner

    CPhI Japan

    Booth #5G-04

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    INSPECTIONS & REGISTRATIONS

    PDF Supplier PDF
    URL Supplier Web Content
    Voluntary Action Indicated
    2010-07-08
    Beuvry-la-foret
    FR
    ORA
    CDER
    Drug Quality Assurance
    Minakem Comapny Banner

    CPhI Japan

    Booth #5G-04

    envelop Contact Supplier

    Contact Supplier
    • FDA
    Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

    INSPECTIONS & REGISTRATIONS

    PDF Supplier PDF
    URL Supplier Web Content
    No Action Indicated
    2009-04-08
    Lasalle
    CA
    ORA
    CDER
    Drug Quality Assurance
    Minakem Delmar

    CPhI Japan

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

    INSPECTIONS & REGISTRATIONS

    PDF Supplier PDF
    URL Supplier Web Content
    No Action Indicated
    2012-11-01
    Lasalle
    CA
    ORA
    CDER
    Drug Quality Assurance
    Minakem Delmar

    CPhI Japan

    Not Confirmed

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    Booth #5G-04

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