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    List of Drug Master Files (DMF) for 14529 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    APOTEX PHARMACHEM INDIA PVT LTD

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    FLUVOXAMINE MALEATE USP

    PDF Supplier PDF
    URL Supplier Web Content
    14529
    Active
    1999-11-12
    Complete
    2015-09-15
    2014-06-05
    II
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    Looking for Drug Master Files (DMF) for 14529 of Apotex Pharmachem India Pvt Ltd

    Looking for Drug Master Files (DMF) for 14529 of Apotex Pharmachem India Pvt Ltd 1

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    Apotex Pharmachem India Pvt Ltd, 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 FLUVOXAMINE MALEATE USP, with a corresponding US DMF Number 14529.

    Remarkably, this DMF maintains an Active status since its submission on November 12, 1999, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of September 15, 2015, and payment made on June 05, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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