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    List of Drug Master Files (DMF) for 32266 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 LAPATINIB DITOSYLATE (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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    LAPATINIB DITOSYLATE

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    32266
    Active
    2018-01-17
    Complete
    2018-12-03
    2018-01-24
    II
    Minakem Delmar

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    Looking for Drug Master Files (DMF) for 32266 of Delmar Chemicals Inc

    Looking for Drug Master Files (DMF) for 32266 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 LAPATINIB DITOSYLATE, with a corresponding US DMF Number 32266.

    Remarkably, this DMF maintains an Active status since its submission on January 17, 2018, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of December 03, 2018, and payment made on January 24, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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