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    List of Drug Master Files (DMF) for 32373 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Unichem Laboratories Limited

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    APREMILAST

    PDF Supplier PDF
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    32373
    Active
    2017-12-22
    Complete
    2018-02-28
    2017-12-22
    II
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    Looking for Drug Master Files (DMF) for 32373 of Unichem Laboratories Ltd

    Looking for Drug Master Files (DMF) for 32373 of Unichem Laboratories Ltd 1

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    Unichem 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 32373.

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

    Their GDUFA DMF Review was successfully complete, with a review date of February 28, 2018, and payment made on December 22, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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