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    List of Drug Master Files (DMF) for 31532 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    FARMABIOS SPA

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    DEXAMETHASONE USP

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    31532
    Active
    2017-03-10
    Complete
    2019-04-09
    2018-03-15
    II
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    Looking for Drug Master Files (DMF) for 31532 of Farmabios Spa

    Looking for Drug Master Files (DMF) for 31532 of Farmabios Spa 1

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    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 DEXAMETHASONE USP, with a corresponding US DMF Number 31532.

    Remarkably, this DMF maintains an Active status since its submission on March 10, 2017, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of April 09, 2019, and payment made on March 15, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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