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    List of Drug Master Files (DMF) for 25228 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 DIFLUPREDNATE (MICRONIZED) (1)

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    FARMABIOS SPA

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    DIFLUPREDNATE (MICRONIZED)

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    25228
    Active
    2011-08-23
    Complete
    2014-08-27
    2014-04-14
    II
    Axplora CB

    Cophex 2024

    Not Confirmed

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    Looking for Drug Master Files (DMF) for 25228 of Farmabios Spa

    Looking for Drug Master Files (DMF) for 25228 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 DIFLUPREDNATE (MICRONIZED), with a corresponding US DMF Number 25228.

    Remarkably, this DMF maintains an Active status since its submission on August 23, 2011, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of August 27, 2014, and payment made on April 14, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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