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    List of Drug Master Files (DMF) for 24468 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Concord Biotech

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    SIROLIMUS

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    24468
    Active
    2011-02-24
    Complete
    2017-08-18
    2017-07-17
    II
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    Looking for Drug Master Files (DMF) for 24468 of Concord Biotech Ltd

    Looking for Drug Master Files (DMF) for 24468 of Concord Biotech Ltd 1

    20

    Concord Biotech Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is SIROLIMUS, with a corresponding US DMF Number 24468.

    Remarkably, this DMF maintains an Active status since its submission on February 24, 2011, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of August 18, 2017, and payment made on July 17, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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