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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Minakem

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    MINAKEM

    EVENTS

    • Webinars & Exhibitions

    PRESENTATION(s)

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    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

    • High Potency API (HPAPI) Manufacturing

    • Continuous Flow Chemistry

    • Development of High Potency APIs (HPAPIs)

    • Custom Synthesis & Development

    • Synthesis of Advanced Intermediates

    • Polymorph, Salt & Cocrystal Study

    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 3 20 64 68 30
    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
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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.

    Budesonide

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

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    USDMF

    Found USDMF

    28441
    Active
    BUDESONIDE MICRONIZED
    2014-06-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-190 - Rev 03
    Valid
    Budesonide Micronised, non-micronis...
    2020-06-09
    Japanese DMF

    Found JDMF

    301MF10045
    Budesonide at 224 avenue de la Dord...
    2019-08-20
    Written Confirmation

    Close WC

    Application Number
    28441
    R1-CEP 2010-190 - Rev 03
    301MF10045
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BUDESONIDE MICRONIZED
    Budesonide Micronised, non-micronis...
    Budesonide at 224 avenue de la Dord...
    Issue/Submission Date
    2014-06-20
    2020-06-09
    2019-08-20
    Minakem Comapny Banner

    CPhI Worldwide 2023

    Booth # 3G29

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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.

    Vinorelbine Tartrate

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    14619
    Active
    VINORELBINE TARTRATE
    1999-12-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-342 - Rev 00
    Valid
    Vinorelbine tartrate
    2018-08-06
    Japanese DMF

    Found JDMF

    303MF10150
    Vinorelbine Tartrate at Rue Fonds J...
    2021-09-17
    Written Confirmation

    Close WC

    Application Number
    14619
    R1-CEP 2011-342 - Rev 00
    303MF10150
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    VINORELBINE TARTRATE
    Vinorelbine tartrate
    Vinorelbine Tartrate at Rue Fonds J...
    Issue/Submission Date
    1999-12-13
    2018-08-06
    2021-09-17
    Minakem Comapny Banner

    CPhI Worldwide 2023

    Booth # 3G29

    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.

    Esomeprazole Magnesium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    28462
    Active
    ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
    2014-07-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-256 - Rev 02
    Valid
    Esomeprazole magnesium trihydrate M...
    2021-06-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28462
    R1-CEP 2012-256 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
    Esomeprazole magnesium trihydrate M...
    Issue/Submission Date
    2014-07-08
    2021-06-03
    Minakem Comapny Banner

    CPhI Worldwide 2023

    Booth # 3G29

    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.

    Esomeprazole Magnesium

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    34026
    Active
    ESOMEPRAZOLE MAGNESIUM DIHYDRATE MI...
    2019-10-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-086 - Rev 00
    Valid
    Esomeprazole magnesium dihydrate Mi...
    2020-08-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34026
    R1-CEP 2015-086 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ESOMEPRAZOLE MAGNESIUM DIHYDRATE MI...
    Esomeprazole magnesium dihydrate Mi...
    Issue/Submission Date
    2019-10-04
    2020-08-31
    Minakem Comapny Banner

    CPhI Worldwide 2023

    Booth # 3G29

    envelop Contact Supplier

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

    Solifenacin Succinate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    30671
    Active
    SOLIFENACIN SUCCINATE
    2016-07-21
    CEP/COS

    Found CEP/COS

    R0-CEP 2016-302 - Rev 00
    Valid
    Solifenacin succinate
    2018-07-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30671
    R0-CEP 2016-302 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SOLIFENACIN SUCCINATE
    Solifenacin succinate
    Issue/Submission Date
    2016-07-21
    2018-07-26
    Minakem Delmar

    2023 Fall Technical Meeting

    Not Confirmed

    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.

    Vinblastine Sulfate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    5335
    Active
    VINBLASTINE SULFATE
    1984-04-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-073 - Rev 02
    Valid
    Vinblastine Sulfate
    2015-08-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5335
    R1-CEP 2004-073 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    VINBLASTINE SULFATE
    Vinblastine Sulfate
    Issue/Submission Date
    1984-04-13
    2015-08-04
    Minakem Comapny Banner

    CPhI Worldwide 2023

    Booth # 3G29

    envelop Contact Supplier

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

    Apixaban

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    30336
    Active
    APIXABAN
    2016-03-14
    CEP/COS

    Close CEP/COS

    <