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    List of Drug Master Files (DMF) for 32929 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Minakem (formerly Delmar Chemicals)

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    01 Minakem (formerly Delmar Chemicals) (1)

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    01 MIRABEGRON (1)

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    01 Canada (1)

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    DELMAR CHEMICALS INC

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    • FDA
    Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids
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    MIRABEGRON

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    32929
    Active
    2018-09-14
    Complete
    2020-12-03
    2018-07-09
    II
    Minakem Delmar

    Cophex 2024

    Not Confirmed

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    Looking for Drug Master Files (DMF) for 32929 of Delmar Chemicals Inc

    Looking for Drug Master Files (DMF) for 32929 of Delmar Chemicals Inc 1

    20

    Delmar Chemicals Inc, based in Canada, is a pharmaceutical company that stands out with its certifications from FDA.

    They are recognized for Minakem is manufacturing small molecules APIs including corticosteroids

    One of their notable products is MIRABEGRON, with a corresponding US DMF Number 32929.

    Remarkably, this DMF maintains an Active status since its submission on September 14, 2018, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of December 03, 2020, and payment made on July 09, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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