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    List of Drug Master Files (DMF) for 32473 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Sun Pharmaceutical Industries Limited

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    APREMILAST

    PDF Supplier PDF
    URL Supplier Web Content
    32473
    Active
    2018-07-16
    Complete
    2018-07-25
    2018-02-09
    II
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    Looking for Drug Master Files (DMF) for 32473 of Sun Pharmaceutical Industries Ltd

    Looking for Drug Master Files (DMF) for 32473 of Sun Pharmaceutical Industries Ltd 1

    20

    Sun Pharmaceutical Industries 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 APREMILAST, with a corresponding US DMF Number 32473.

    Remarkably, this DMF maintains an Active status since its submission on July 16, 2018, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of July 25, 2018, and payment made on February 09, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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