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    List of Drug Master Files (DMF) for 30622 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Alkem Laboratories

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    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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    ALKEM LABORATORIES LTD

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    DIMETHYL FUMARATE

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    30622
    Active
    2016-07-26
    Complete
    2016-12-02
    2016-07-25
    II
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    Looking for Drug Master Files (DMF) for 30622 of Alkem Laboratories Ltd

    Looking for Drug Master Files (DMF) for 30622 of Alkem Laboratories Ltd 1

    20

    Alkem 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 DIMETHYL FUMARATE, with a corresponding US DMF Number 30622.

    Remarkably, this DMF maintains an Active status since its submission on July 26, 2016, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of December 02, 2016, and payment made on July 25, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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