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    List of Drug Master Files (DMF) for 32114 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    APREMILAST

    PDF Supplier PDF
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    32114
    Active
    2017-10-03
    Complete
    2017-11-01
    2017-10-05
    II
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    Looking for Drug Master Files (DMF) for 32114 of Alkem Laboratories Ltd

    Looking for Drug Master Files (DMF) for 32114 of Alkem Laboratories Ltd 1

    20

    Alkem Laboratories 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 32114.

    Remarkably, this DMF maintains an Active status since its submission on October 03, 2017, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of November 01, 2017, and payment made on October 05, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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