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    List of Drug Master Files (DMF) for 31809 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Lek Pharmaceuticals

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    PharmaCompass

    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    01 Lek Pharmaceuticals (1)

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    01 APREMILAST (1)

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    APREMILAST

    PDF Supplier PDF
    URL Supplier Web Content
    31809
    Active
    2017-09-27
    Complete
    2017-11-16
    2017-09-11
    II
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    Looking for Drug Master Files (DMF) for 31809 of Lek Pharmaceuticals Dd

    Looking for Drug Master Files (DMF) for 31809 of Lek Pharmaceuticals Dd 1

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    Lek Pharmaceuticals Dd, based in Slovenia, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is APREMILAST, with a corresponding US DMF Number 31809.

    Remarkably, this DMF maintains an Active status since its submission on September 27, 2017, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of November 16, 2017, and payment made on September 11, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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