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    List of Drug Master Files (DMF) for 31141 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Polpharma

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    ZAKLADY FARMACEUTYCZNE POLPHARMA SA

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    • FDA
    • EDQM
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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    APREMILAST

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    Other DMF EU
    31141
    Active
    2016-11-09
    Complete
    2017-04-07
    2016-12-20
    II
    Polpharma CB

    CPhI North America

    Booth # 814

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    Looking for Drug Master Files (DMF) for 31141 of Zaklady Farmaceutyczne Polpharma Sa

    Looking for Drug Master Files (DMF) for 31141 of Zaklady Farmaceutyczne Polpharma Sa 1

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    Zaklady Farmaceutyczne Polpharma Sa, based in Poland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    They are recognized for Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    One of their notable products is APREMILAST, with a corresponding US DMF Number 31141.

    Remarkably, this DMF maintains an Active status since its submission on November 09, 2016, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of April 07, 2017, and payment made on December 20, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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