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    List of Drug Master Files (DMF) for 12749 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 BETAMETHASONE VALERATE (1)

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    01 Germany (1)

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    FARMABIOS SPA

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    BETAMETHASONE VALERATE

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    12749
    Active
    1997-11-18
    Complete
    2018-08-14
    2018-07-09
    II
    Axplora CB

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    Looking for Drug Master Files (DMF) for 12749 of Farmabios Spa

    Looking for Drug Master Files (DMF) for 12749 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 BETAMETHASONE VALERATE, with a corresponding US DMF Number 12749.

    Remarkably, this DMF maintains an Active status since its submission on November 18, 1997, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of August 14, 2018, and payment made on July 09, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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