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    List of Drug Master Files (DMF) for 25915 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    BOSENTAN MONOHYDRATE

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    25915
    Active
    2012-04-02
    Complete
    2014-05-28
    2014-04-04
    II
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    Looking for Drug Master Files (DMF) for 25915 of Zydus Lifesciences Ltd

    Looking for Drug Master Files (DMF) for 25915 of Zydus Lifesciences Ltd 1

    20

    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 BOSENTAN MONOHYDRATE, with a corresponding US DMF Number 25915.

    Remarkably, this DMF maintains an Active status since its submission on April 02, 2012, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of May 28, 2014, and payment made on April 04, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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