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    List of Drug Master Files (DMF) for 25933 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    01 BUSULFAN (1)

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    FARMABIOS SPA

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    BUSULFAN

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    25933
    Active
    2012-03-27
    Complete
    2013-08-08
    2012-12-17
    II
    Axplora CB

    Cophex 2024

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    Looking for Drug Master Files (DMF) for 25933 of Farmabios Spa

    Looking for Drug Master Files (DMF) for 25933 of Farmabios Spa 1

    20

    Farmabios Spa, based in Germany, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

    They are recognized for Axplora- The partner of choice for complex APIs.

    One of their notable products is BUSULFAN, with a corresponding US DMF Number 25933.

    Remarkably, this DMF maintains an Active status since its submission on March 27, 2012, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of August 08, 2013, and payment made on December 17, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II

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