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    List of Drug Master Files (DMF) for 26901 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Alkem Laboratories

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

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    DRONEDARONE HYDROCHLORIDE

    PDF Supplier PDF
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    26901
    Active
    2013-03-26
    Complete
    2013-07-11
    2013-04-08
    II
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    Looking for Drug Master Files (DMF) for 26901 of Alkem Laboratories Ltd

    Looking for Drug Master Files (DMF) for 26901 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 DRONEDARONE HYDROCHLORIDE, with a corresponding US DMF Number 26901.

    Remarkably, this DMF maintains an Active status since its submission on March 26, 2013, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of July 11, 2013, and payment made on April 08, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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