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    List of Drug Master Files (DMF) for 30248 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Lupin Ltd

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    APREMILAST

    PDF Supplier PDF
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    30248
    Active
    2016-04-06
    Complete
    2016-04-24
    2016-04-04
    II
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    Looking for Drug Master Files (DMF) for 30248 of Lupin Ltd

    Looking for Drug Master Files (DMF) for 30248 of Lupin Ltd 1

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    Lupin 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 30248.

    Remarkably, this DMF maintains an Active status since its submission on April 06, 2016, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of April 24, 2016, and payment made on April 04, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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