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    List of Drug Master Files (DMF) for 12813 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    01 BECLOMETHASONE DIPROPIONATE (1)

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    FARMABIOS SPA

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    BECLOMETHASONE DIPROPIONATE

    PDF Supplier PDF
    URL Supplier Web Content
    12813
    Active
    1998-01-05
    Complete
    2019-04-25
    2019-04-22
    II
    Axplora CB

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    Looking for Drug Master Files (DMF) for 12813 of Farmabios Spa

    Looking for Drug Master Files (DMF) for 12813 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 BECLOMETHASONE DIPROPIONATE, with a corresponding US DMF Number 12813.

    Remarkably, this DMF maintains an Active status since its submission on January 05, 1998, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of April 25, 2019, and payment made on April 22, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II

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