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    List of Drug Master Files (DMF) for 27717 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 LOTEPREDNOL ETABONATE STERILE MICRONIZED (1)

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    01 Germany (1)

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    FARMABIOS SPA

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    LOTEPREDNOL ETABONATE STERILE MICRONIZED

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    27717
    Active
    2013-11-11
    Complete
    2023-07-05
    2023-01-24
    II
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    Looking for Drug Master Files (DMF) for 27717 of Farmabios Spa

    Looking for Drug Master Files (DMF) for 27717 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 LOTEPREDNOL ETABONATE STERILE MICRONIZED, with a corresponding US DMF Number 27717.

    Remarkably, this DMF maintains an Active status since its submission on November 11, 2013, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of July 05, 2023, and payment made on January 24, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II

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