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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Minakem to the U.S. FDA. Original Data : FDA Website

    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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    • FDA
    Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

    APIXABAN

    PDF Supplier PDF
    URL Supplier Web Content
    DELMAR CHEMICALS INC
    Active
    30336
    Complete
    2016-08-15
    2016-03-28
    2016-03-14
    II
    Minakem Delmar

    Iran Expo

    Not Confirmed

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

    BUDESONIDE MICRONIZED

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF CA, IDN
    MINAKEM
    Active
    28441
    Complete
    2017-03-03
    2017-02-10
    2014-06-20
    II
    Minakem Comapny Banner

    CPhI North America

    Booth #1210

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    • FDA
    Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

    ESLICARBAZEPINE ACETATE

    PDF Supplier PDF
    URL Supplier Web Content
    DELMAR CHEMICALS INC
    Active
    31791
    Complete
    2018-07-27
    2017-06-09
    2017-06-05
    II
    Minakem Delmar

    Iran Expo

    Not Confirmed

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

    ESMOLOL HYDROCHLORIDE

    PDF Supplier PDF
    URL Supplier Web Content
    DELMAR CHEMICALS INC
    Active
    4475
    Complete
    2020-05-21
    2020-05-15
    1982-03-12
    II
    Minakem Delmar

    Iran Expo

    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.

    ESOMEPRAZOLE MAGNESIUM DIHYDRATE MI...

    PDF Supplier PDF
    URL Supplier Web Content
    MINAKEM
    Active
    34026
    Complete
    2019-11-25
    2019-10-16
    2019-10-04
    II
    Minakem Comapny Banner

    CPhI North America

    Booth #1210

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    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 TRIHYDRATE

    PDF Supplier PDF
    URL Supplier Web Content
    MINAKEM
    Active
    28462
    N/A
    2014-07-08
    II
    Minakem Comapny Banner

    CPhI North America

    Booth #1210

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

    FLUORESCEIN

    PDF Supplier PDF
    URL Supplier Web Content
    DELMAR CHEMICALS INC
    Active
    18791
    N/A
    2005-09-16
    II
    Minakem Delmar

    Iran Expo

    Not Confirmed

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

    LAPATINIB DITOSYLATE

    PDF Supplier PDF
    URL Supplier Web Content
    DELMAR CHEMICALS INC
    Active
    32266
    Complete
    2018-12-03
    2018-01-24
    2018-01-17
    II
    Minakem Delmar

    Iran Expo

    Not Confirmed

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

    METHAZOLAMIDE

    PDF Supplier PDF
    URL Supplier Web Content
    DELMAR CHEMICALS INC
    Active
    8676
    N/A
    1990-08-01
    II
    Minakem Delmar

    Iran Expo

    Not Confirmed

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

    MIRABEGRON

    PDF Supplier PDF
    URL Supplier Web Content
    DELMAR CHEMICALS INC
    Active
    32929
    Complete
    2020-12-03
    2018-07-09
    2018-09-14
    II
    Minakem Delmar

    Iran Expo

    Not Confirmed

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

    MONTELUKAST SODIUM THIOL ACID

    PDF Supplier PDF
    URL Supplier Web Content
    DELMAR CHEMICALS INC
    Active
    16243
    N/A
    2002-11-15
    II
    Minakem Delmar

    Iran Expo

    Not Confirmed

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

    PENTAMIDINE ISETHIONATE

    PDF Supplier PDF
    URL Supplier Web Content
    DELMAR CHEMICALS INC
    Active
    6492
    Complete
    2014-03-31
    2013-09-17
    1986-07-23
    II
    Minakem Delmar

    Iran Expo

    Not Confirmed

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

    PYRAZINAMIDE

    PDF Supplier PDF
    URL Supplier Web Content
    DELMAR CHEMICALS INC
    Active
    15325
    N/A
    2001-02-28
    II
    Minakem Delmar

    Iran Expo

    Not Confirmed

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

    ROSUVASTATIN CALCIUM

    PDF Supplier PDF
    URL Supplier Web Content
    DELMAR CHEMICALS INC
    Active
    29190
    Complete
    2016-04-08
    2015-09-25
    2015-12-03
    II
    Minakem Delmar

    Iran Expo

    Not Confirmed

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

    SOLIFENACIN SUCCINATE

    PDF Supplier PDF
    URL Supplier Web Content
    DELMAR CHEMICALS INC
    Active
    30671
    Complete
    2017-06-27
    2016-09-23
    2016-07-21
    II
    Minakem Delmar

    Iran Expo

    Not Confirmed

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

    SORAFENIB HEMITOSYLATE

    PDF Supplier PDF
    URL Supplier Web Content
    DELMAR CHEMICALS INC
    Active
    32140
    Complete
    2018-07-27
    2018-01-19
    2017-12-20
    II
    Minakem Delmar

    Iran Expo

    Not Confirmed

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

    SUCCINYLCHOLINE CHLORIDE

    PDF Supplier PDF
    URL Supplier Web Content
    DELMAR CHEMICALS INC
    Active
    23224
    Complete
    2018-03-02
    2018-02-12
    2009-10-29
    II
    Minakem Delmar

    Iran Expo

    Not Confirmed

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

    TOFACITINIB CITRATE

    PDF Supplier PDF
    URL Supplier Web Content
    DELMAR CHEMICALS INC
    Active
    33332
    N/A
    2018-12-21
    II
    Minakem Delmar

    Iran Expo

    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
    MINAKEM HIGH POTENT
    Active
    5335
    Complete
    2018-03-27
    2017-11-27
    1984-04-13
    II
    Minakem Comapny Banner

    CPhI North America

    Booth #1210

    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.

    VINCRISTINE SULFATE

    PDF Supplier PDF
    URL Supplier Web Content
    MINAKEM HIGH POTENT
    Active
    4932
    Complete
    2021-10-25
    2021-10-21
    1983-06-01
    II
    Minakem Comapny Banner

    CPhI North America

    Booth #1210

    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.

    VINORELBINE TARTRATE

    PDF Supplier PDF
    URL Supplier Web Content
    MINAKEM HIGH POTENT
    Active
    14619
    Complete
    2016-04-23
    2016-03-23
    1999-12-13
    II
    Minakem Comapny Banner

    CPhI North America

    Booth #1210

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