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    List of Drug Master Files (DMF) for 31266 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    APREMILAST (FORM M)

    PDF Supplier PDF
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    31266
    Active
    2017-03-22
    Complete
    2017-06-09
    2017-05-25
    II
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    Looking for Drug Master Files (DMF) for 31266 of Lupin Manufacturing Solutions Limited

    Looking for Drug Master Files (DMF) for 31266 of Lupin Manufacturing Solutions Limited 1

    20

    Lupin Manufacturing Solutions Limited, 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 (FORM M), with a corresponding US DMF Number 31266.

    Remarkably, this DMF maintains an Active status since its submission on March 22, 2017, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of June 09, 2017, and payment made on May 25, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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