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    List of Drug Master Files (DMF) for 26904 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Apotex Fermentation Inc.

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    01 Apotex Fermentation Inc. (1)

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    SIROLIMUS DRUG SUBSTANCE

    PDF Supplier PDF
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    26904
    Active
    2013-02-27
    Complete
    2014-07-09
    2013-02-26
    II
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    Looking for Drug Master Files (DMF) for 26904 of Apotex Pharmachem Inc

    Looking for Drug Master Files (DMF) for 26904 of Apotex Pharmachem Inc 1

    20

    Apotex Pharmachem Inc, based in Canada, is a pharmaceutical company that stands out with its certifications from FDA.

    One of their notable products is SIROLIMUS DRUG SUBSTANCE, with a corresponding US DMF Number 26904.

    Remarkably, this DMF maintains an Active status since its submission on February 27, 2013, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of July 09, 2014, and payment made on February 26, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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