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    List of Drug Master Files (DMF) for 18352 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 HALCINONIDE (1)

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    FARMABIOS SPA

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    HALCINONIDE

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    18352
    Active
    2005-05-13
    Complete
    2016-11-10
    2016-09-29
    II
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    Looking for Drug Master Files (DMF) for 18352 of Farmabios Spa

    Looking for Drug Master Files (DMF) for 18352 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 HALCINONIDE, with a corresponding US DMF Number 18352.

    Remarkably, this DMF maintains an Active status since its submission on May 13, 2005, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of November 10, 2016, and payment made on September 29, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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