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    List of Drug Master Files (DMF) for 25809 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Emcure Pharmaceuticals

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    ACAMPROSATE CALCIUM USP

    PDF Supplier PDF
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    25809
    Active
    2012-03-30
    Complete
    2014-05-29
    2014-01-22
    II
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    Looking for Drug Master Files (DMF) for 25809 of Emcure Pharmaceuticals Ltd

    Looking for Drug Master Files (DMF) for 25809 of Emcure Pharmaceuticals Ltd 1

    20

    Emcure Pharmaceuticals Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

    One of their notable products is ACAMPROSATE CALCIUM USP, with a corresponding US DMF Number 25809.

    Remarkably, this DMF maintains an Active status since its submission on March 30, 2012, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of May 29, 2014, and payment made on January 22, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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