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    List of Drug Master Files (DMF) for 12662 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    01 MEGESTROL ACETATE (1)

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    FARMABIOS SPA

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    MEGESTROL ACETATE

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    12662
    Active
    1997-09-20
    Complete
    2021-03-25
    2021-03-22
    II
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    Looking for Drug Master Files (DMF) for 12662 of Farmabios Spa

    Looking for Drug Master Files (DMF) for 12662 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 MEGESTROL ACETATE, with a corresponding US DMF Number 12662.

    Remarkably, this DMF maintains an Active status since its submission on September 20, 1997, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of March 25, 2021, and payment made on March 22, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II

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