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    List of Drug Master Files (DMF) for 27697 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    ATORVASTATIN CALCIUM USP

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    27697
    Active
    2013-12-18
    Complete
    2014-01-24
    2013-11-22
    II
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    Looking for Drug Master Files (DMF) for 27697 of Zydus Lifesciences Ltd

    Looking for Drug Master Files (DMF) for 27697 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 ATORVASTATIN CALCIUM USP, with a corresponding US DMF Number 27697.

    Remarkably, this DMF maintains an Active status since its submission on December 18, 2013, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of January 24, 2014, and payment made on November 22, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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