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    List of Drug Master Files (DMF) for 33572 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Aurobindo Pharma Limited

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    BREXPIPRAZOLE

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    33572
    Active
    2019-02-13
    Complete
    2019-03-01
    2019-02-11
    II
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    Looking for Drug Master Files (DMF) for 33572 of Aurobindo Pharma Ltd

    Looking for Drug Master Files (DMF) for 33572 of Aurobindo Pharma Ltd 1

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    Aurobindo Pharma 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 BREXPIPRAZOLE, with a corresponding US DMF Number 33572.

    Remarkably, this DMF maintains an Active status since its submission on February 13, 2019, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of March 01, 2019, and payment made on February 11, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II

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