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    List of Drug Master Files (DMF) for 25331 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Asahi Kasei Finechem

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    TRANEXAMIC ACID USP

    PDF Supplier PDF
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    25331
    Active
    2011-09-14
    Complete
    2018-12-20
    2018-12-11
    II
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    Looking for Drug Master Files (DMF) for 25331 of Asahi Kasei Finechem Co Ltd

    Looking for Drug Master Files (DMF) for 25331 of Asahi Kasei Finechem Co Ltd 1

    20

    Asahi Kasei Finechem Co Ltd, based in Japan, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is TRANEXAMIC ACID USP, with a corresponding US DMF Number 25331.

    Remarkably, this DMF maintains an Active status since its submission on September 14, 2011, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of December 20, 2018, and payment made on December 11, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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