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    List of Drug Master Files (DMF) for 23924 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Apicore LLC

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    BUSULFAN USP

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    23924
    Active
    2010-08-05
    Complete
    2015-06-10
    2015-05-27
    II
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    Looking for Drug Master Files (DMF) for 23924 of Apicore Us Llc

    Looking for Drug Master Files (DMF) for 23924 of Apicore Us Llc 1

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    Apicore Us Llc, based in India, is a pharmaceutical company that stands out with its certifications from FDA.

    One of their notable products is BUSULFAN USP, with a corresponding US DMF Number 23924.

    Remarkably, this DMF maintains an Active status since its submission on August 05, 2010, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of June 10, 2015, and payment made on May 27, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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