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    List of Drug Master Files (DMF) for 28674 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    ZAKLADY FARMACEUTYCZNE POLPHARMA SA

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

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    Other DMF Canada
    28674
    Active
    2014-09-24
    Complete
    2015-02-23
    2014-11-21
    II
    Polpharma CB

    CPhI North America

    Booth # 814

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    Looking for Drug Master Files (DMF) for 28674 of Zaklady Farmaceutyczne Polpharma Sa

    Looking for Drug Master Files (DMF) for 28674 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 TICAGRELOR, with a corresponding US DMF Number 28674.

    Remarkably, this DMF maintains an Active status since its submission on September 24, 2014, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of February 23, 2015, and payment made on November 21, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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