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    List of Drug Master Files (DMF) for 33361 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Fermion Oy

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    01 Fermion Oy (1)

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    01 NINTEDANIB ESYLATE (1)

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    FERMION OY

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    • FDA
    • EDQM
    Virtual BoothWith Fermion, start the journey of your innovative API.
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    NINTEDANIB ESYLATE

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    Other DMF EU
    33361
    Active
    2019-01-02
    Complete
    2019-03-26
    2018-12-20
    II
    fermion

    CPhI North America

    Booth #1117

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    Looking for Drug Master Files (DMF) for 33361 of Fermion Oy

    Looking for Drug Master Files (DMF) for 33361 of Fermion Oy 1

    20

    Fermion Oy, based in Finland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    They are recognized for With Fermion, start the journey of your innovative API.

    One of their notable products is NINTEDANIB ESYLATE, with a corresponding US DMF Number 33361.

    Remarkably, this DMF maintains an Active status since its submission on January 02, 2019, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of March 26, 2019, and payment made on December 20, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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