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    List of Drug Master Files (DMF) for 25791 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    01 Axplora (1)

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    01 MELPHALAN HYDROCHLORIDE (1)

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    01 Germany (1)

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    FARMABIOS SPA

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    MELPHALAN HYDROCHLORIDE

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    25791
    Active
    2012-02-14
    Complete
    2014-02-21
    2013-09-05
    II
    Axplora CB

    In-cosmetics Global

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    Looking for Drug Master Files (DMF) for 25791 of Farmabios Spa

    Looking for Drug Master Files (DMF) for 25791 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 MELPHALAN HYDROCHLORIDE, with a corresponding US DMF Number 25791.

    Remarkably, this DMF maintains an Active status since its submission on February 14, 2012, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of February 21, 2014, and payment made on September 05, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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