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    List of Drug Master Files (DMF) for 7882 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Egis Pharmaceuticals PLC

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    EGIS PHARMACEUTICALS PLC

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    • FDA
    • EDQM
    Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
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    PROMETHAZINE HCL

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    Other DMF BR
    7882
    Active
    1989-01-24
    Complete
    2021-06-10
    2021-06-07
    II
    Egis Pharmaceuticals

    euroPLX Dublin

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    Looking for Drug Master Files (DMF) for 7882 of Egis Pharmaceuticals Plc

    Looking for Drug Master Files (DMF) for 7882 of Egis Pharmaceuticals Plc 1

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    Egis Pharmaceuticals Plc, based in Hungary, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    They are recognized for Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

    One of their notable products is PROMETHAZINE HCL, with a corresponding US DMF Number 7882.

    Remarkably, this DMF maintains an Active status since its submission on January 24, 1989, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of June 10, 2021, and payment made on June 07, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II

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