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    List of Drug Master Files (DMF) for 11315 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 FLUOXETINE HYDROCHLORIDE USP (1)

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    FERMION OY

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    FLUOXETINE HYDROCHLORIDE USP

    PDF Supplier PDF
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    NA Not Available For Sales
    11315
    Active
    1995-01-26
    Complete
    2014-10-13
    2014-10-02
    II
    fermion

    CPhI North America

    Booth #1117

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    Looking for Drug Master Files (DMF) for 11315 of Fermion Oy

    Looking for Drug Master Files (DMF) for 11315 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 FLUOXETINE HYDROCHLORIDE USP, with a corresponding US DMF Number 11315.

    Remarkably, this DMF maintains an Active status since its submission on January 26, 1995, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of October 13, 2014, and payment made on October 02, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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