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    List of Drug Master Files (DMF) for 30787 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    ESOMEPRAZOLE MAGNESIUM TRIHYDRATE USP

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    30787
    Active
    2016-08-17
    Complete
    2016-11-04
    2016-08-30
    II
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    Looking for Drug Master Files (DMF) for 30787 of Alkem Laboratories Ltd

    Looking for Drug Master Files (DMF) for 30787 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 ESOMEPRAZOLE MAGNESIUM TRIHYDRATE USP, with a corresponding US DMF Number 30787.

    Remarkably, this DMF maintains an Active status since its submission on August 17, 2016, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of November 04, 2016, and payment made on August 30, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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