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    List of Drug Master Files (DMF) for 16972 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    GLYCOPYRROLATE

    PDF Supplier PDF
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    16972
    Active
    2003-11-13
    Complete
    2015-03-13
    2015-03-06
    II
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    Looking for Drug Master Files (DMF) for 16972 of Amsa Spa

    Looking for Drug Master Files (DMF) for 16972 of Amsa Spa 1

    20

    Amsa Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA.

    One of their notable products is GLYCOPYRROLATE, with a corresponding US DMF Number 16972.

    Remarkably, this DMF maintains an Active status since its submission on November 13, 2003, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of March 13, 2015, and payment made on March 06, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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