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    List of Drug Master Files (DMF) for 31811 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Emcure Pharmaceuticals

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    EMCURE PHARMACEUTICALS LTD

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    DOFETILIDE USP

    PDF Supplier PDF
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    31811
    Active
    2017-08-10
    Complete
    2018-10-01
    2018-08-01
    II
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    Looking for Drug Master Files (DMF) for 31811 of Emcure Pharmaceuticals Ltd

    Looking for Drug Master Files (DMF) for 31811 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 DOFETILIDE USP, with a corresponding US DMF Number 31811.

    Remarkably, this DMF maintains an Active status since its submission on August 10, 2017, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of October 01, 2018, and payment made on August 01, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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