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    List of Drug Master Files (DMF) for 16492 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 FLURANDRENOLIDE (1)

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    FARMABIOS SPA

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    FLURANDRENOLIDE

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    16492
    Active
    2003-03-26
    Complete
    2012-10-23
    2012-11-28
    II
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    Looking for Drug Master Files (DMF) for 16492 of Farmabios Spa

    Looking for Drug Master Files (DMF) for 16492 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 FLURANDRENOLIDE, with a corresponding US DMF Number 16492.

    Remarkably, this DMF maintains an Active status since its submission on March 26, 2003, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of October 23, 2012, and payment made on November 28, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II

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