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    List of Drug Master Files (DMF) for 26418 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    IRBESARTAN USP

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    26418
    Active
    2012-09-11
    Complete
    2013-06-04
    2012-11-23
    II
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    Looking for Drug Master Files (DMF) for 26418 of Divis Laboratories Ltd

    Looking for Drug Master Files (DMF) for 26418 of Divis Laboratories Ltd 1

    20

    Divis 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 IRBESARTAN USP, with a corresponding US DMF Number 26418.

    Remarkably, this DMF maintains an Active status since its submission on September 11, 2012, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of June 04, 2013, and payment made on November 23, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II

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