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    List of Drug Master Files (DMF) for 22905 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Emcure Pharmaceuticals

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    CARMUSTINE USP

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    22905
    Active
    2009-06-22
    Complete
    2016-11-10
    2016-10-17
    II
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    Looking for Drug Master Files (DMF) for 22905 of Emcure Pharmaceuticals Ltd

    Looking for Drug Master Files (DMF) for 22905 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 CARMUSTINE USP, with a corresponding US DMF Number 22905.

    Remarkably, this DMF maintains an Active status since its submission on June 22, 2009, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of November 10, 2016, and payment made on October 17, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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