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    List of Drug Master Files (DMF) for 19477 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 FLUNISOLIDE ANHYDROUS USP (1)

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    01 Germany (1)

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    FARMABIOS SPA

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    FLUNISOLIDE ANHYDROUS USP

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    19477
    Active
    2006-05-31
    Complete
    2013-03-07
    2013-02-15
    II
    Axplora CB

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    Looking for Drug Master Files (DMF) for 19477 of Farmabios Spa

    Looking for Drug Master Files (DMF) for 19477 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 FLUNISOLIDE ANHYDROUS USP, with a corresponding US DMF Number 19477.

    Remarkably, this DMF maintains an Active status since its submission on May 31, 2006, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of March 07, 2013, and payment made on February 15, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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