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    List of Drug Master Files (DMF) for 22528 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Concord Biotech

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    VANCOMYCIN HYDROCHLORIDE USP

    PDF Supplier PDF
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    22528
    Active
    2009-02-10
    Complete
    2017-01-19
    2016-12-19
    II
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    Looking for Drug Master Files (DMF) for 22528 of Concord Biotech Ltd

    Looking for Drug Master Files (DMF) for 22528 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 VANCOMYCIN HYDROCHLORIDE USP, with a corresponding US DMF Number 22528.

    Remarkably, this DMF maintains an Active status since its submission on February 10, 2009, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of January 19, 2017, and payment made on December 19, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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