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    List of Drug Master Files (DMF) for 32149 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Macleods Pharmaceuticals Limited

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    APREMILAST

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    32149
    Active
    2017-10-18
    Complete
    2017-12-12
    2017-10-25
    II
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    Looking for Drug Master Files (DMF) for 32149 of Macleods Pharmaceuticals Ltd

    Looking for Drug Master Files (DMF) for 32149 of Macleods Pharmaceuticals Ltd 1

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    Macleods Pharmaceuticals 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 32149.

    Remarkably, this DMF maintains an Active status since its submission on October 18, 2017, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of December 12, 2017, and payment made on October 25, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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