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    List of Drug Master Files (DMF) for 31979 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Emcure Pharmaceuticals

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    BEXAROTENE

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    31979
    Active
    2017-10-03
    Complete
    2020-10-27
    2020-09-18
    II
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    Looking for Drug Master Files (DMF) for 31979 of Emcure Pharmaceuticals Ltd

    Looking for Drug Master Files (DMF) for 31979 of Emcure Pharmaceuticals Ltd 1

    20

    Emcure Pharmaceuticals 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 BEXAROTENE, with a corresponding US DMF Number 31979.

    Remarkably, this DMF maintains an Active status since its submission on October 03, 2017, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of October 27, 2020, and payment made on September 18, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II

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