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    List of Drug Master Files (DMF) for 26148 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 HEMIHYDRATE (MICRONIZED) (1)

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    FARMABIOS SPA

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    FLUNISOLIDE HEMIHYDRATE (MICRONIZED)

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    26148
    Active
    2012-06-12
    Complete
    2014-06-02
    2014-05-27
    II
    Axplora CB

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    Looking for Drug Master Files (DMF) for 26148 of Farmabios Spa

    Looking for Drug Master Files (DMF) for 26148 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 HEMIHYDRATE (MICRONIZED), with a corresponding US DMF Number 26148.

    Remarkably, this DMF maintains an Active status since its submission on June 12, 2012, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of June 02, 2014, and payment made on May 27, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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