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    List of Drug Master Files (DMF) for 31992 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    DAPAGLIFLOZIN

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    31992
    Active
    2017-08-31
    Complete
    2017-10-05
    2017-08-17
    II
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    Looking for Drug Master Files (DMF) for 31992 of Zydus Lifesciences Ltd

    Looking for Drug Master Files (DMF) for 31992 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 DAPAGLIFLOZIN, with a corresponding US DMF Number 31992.

    Remarkably, this DMF maintains an Active status since its submission on August 31, 2017, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of October 05, 2017, and payment made on August 17, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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