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    List of Drug Master Files (DMF) for 26976 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Alembic Pharmaceuticals Limited

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    ALEMBIC PHARMACEUTICALS LTD

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    DRONEDARONE HYDROCHLORIDE USP

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    26976
    Active
    2013-03-26
    Complete
    2013-07-19
    2013-06-24
    II
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    Looking for Drug Master Files (DMF) for 26976 of Alembic Pharmaceuticals Ltd

    Looking for Drug Master Files (DMF) for 26976 of Alembic Pharmaceuticals Ltd 1

    20

    Alembic 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 DRONEDARONE HYDROCHLORIDE USP, with a corresponding US DMF Number 26976.

    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 19, 2013, and payment made on June 24, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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