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    List of Drug Master Files (DMF) for 26948 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Emcure Pharmaceuticals

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    DECITABINE MONOHYDRATE

    PDF Supplier PDF
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    26948
    Active
    2013-03-29
    Complete
    2014-05-13
    2014-01-22
    II
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    Looking for Drug Master Files (DMF) for 26948 of Emcure Pharmaceuticals Ltd

    Looking for Drug Master Files (DMF) for 26948 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 DECITABINE MONOHYDRATE, with a corresponding US DMF Number 26948.

    Remarkably, this DMF maintains an Active status since its submission on March 29, 2013, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of May 13, 2014, and payment made on January 22, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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