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    List of Drug Master Files (DMF) for 29839 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Emcure Pharmaceuticals

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    CYCLOPHOSPHAMIDE USP

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    29839
    Active
    2015-09-30
    Complete
    2015-12-15
    2015-09-29
    II
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    Looking for Drug Master Files (DMF) for 29839 of Emcure Pharmaceuticals Ltd

    Looking for Drug Master Files (DMF) for 29839 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 CYCLOPHOSPHAMIDE USP, with a corresponding US DMF Number 29839.

    Remarkably, this DMF maintains an Active status since its submission on September 30, 2015, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of December 15, 2015, and payment made on September 29, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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