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    List of Drug Master Files (DMF) for 28285 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    DABIGATRAN ETEXILATE MESYLATE

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    28285
    Active
    2014-05-29
    Complete
    2014-06-24
    2014-05-19
    II
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    Looking for Drug Master Files (DMF) for 28285 of Zydus Lifesciences Ltd

    Looking for Drug Master Files (DMF) for 28285 of Zydus Lifesciences Ltd 1

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    Zydus Lifesciences 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 DABIGATRAN ETEXILATE MESYLATE, with a corresponding US DMF Number 28285.

    Remarkably, this DMF maintains an Active status since its submission on May 29, 2014, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of June 24, 2014, and payment made on May 19, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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