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    List of Drug Master Files (DMF) for 32896 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    FARMABIOS SPA

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    STERILE PREDNISOLONE-21-ACETATE MICRONIZED

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    32896
    Active
    2018-07-16
    Complete
    2020-12-29
    2020-09-22
    II
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    Looking for Drug Master Files (DMF) for 32896 of Farmabios Spa

    Looking for Drug Master Files (DMF) for 32896 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 STERILE PREDNISOLONE-21-ACETATE MICRONIZED, with a corresponding US DMF Number 32896.

    Remarkably, this DMF maintains an Active status since its submission on July 16, 2018, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of December 29, 2020, and payment made on September 22, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II

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