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    List of Drug Master Files (DMF) for 27451 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Apotex Pharmachem

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    APOTEX PHARMACHEM INC

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    BUDESONIDE USP

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    27451
    Active
    2013-11-01
    Complete
    2013-12-18
    2013-09-19
    II
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    Looking for Drug Master Files (DMF) for 27451 of Apotex Pharmachem Inc

    Looking for Drug Master Files (DMF) for 27451 of Apotex Pharmachem Inc 1

    20

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

    One of their notable products is BUDESONIDE USP, with a corresponding US DMF Number 27451.

    Remarkably, this DMF maintains an Active status since its submission on November 01, 2013, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of December 18, 2013, and payment made on September 19, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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