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    List of Drug Master Files (DMF) for 20649 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 IRINOTECAN HYDROCHLORIDE (1)

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    01 Finland (1)

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    FERMION OY

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    IRINOTECAN HYDROCHLORIDE

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    20649
    Active
    2007-06-29
    Complete
    2013-09-14
    2013-09-05
    II
    fermion

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    Looking for Drug Master Files (DMF) for 20649 of Fermion Oy

    Looking for Drug Master Files (DMF) for 20649 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 IRINOTECAN HYDROCHLORIDE, with a corresponding US DMF Number 20649.

    Remarkably, this DMF maintains an Active status since its submission on June 29, 2007, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of September 14, 2013, and payment made on September 05, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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