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    List of Drug Master Files (DMF) for 21430 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 FLUOCINONIDE, MICRONIZED BP/USP (1)

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    FARMABIOS SPA

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    FLUOCINONIDE, MICRONIZED BP/USP

    PDF Supplier PDF
    URL Supplier Web Content
    21430
    Active
    2008-03-13
    Complete
    2014-08-20
    2014-01-16
    II
    Axplora CB

    Cophex 2024

    Not Confirmed

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    Looking for Drug Master Files (DMF) for 21430 of Farmabios Spa

    Looking for Drug Master Files (DMF) for 21430 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 FLUOCINONIDE, MICRONIZED BP/USP, with a corresponding US DMF Number 21430.

    Remarkably, this DMF maintains an Active status since its submission on March 13, 2008, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of August 20, 2014, and payment made on January 16, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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