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    List of Drug Master Files (DMF) for 20463 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 FLUTICASONE PROPIONATE USP/PH.EUR. (MICRONIZED) (1)

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    01 Germany (1)

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    FARMABIOS SPA

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    FLUTICASONE PROPIONATE USP/PH.EUR. (MICRONIZED)

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    20463
    Active
    2007-04-24
    Complete
    2018-11-02
    2018-10-31
    II
    Axplora CB

    FoodTech International

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    Looking for Drug Master Files (DMF) for 20463 of Farmabios Spa

    Looking for Drug Master Files (DMF) for 20463 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 FLUTICASONE PROPIONATE USP/PH.EUR. (MICRONIZED), with a corresponding US DMF Number 20463.

    Remarkably, this DMF maintains an Active status since its submission on April 24, 2007, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of November 02, 2018, and payment made on October 31, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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