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    List of Drug Master Files (DMF) for 16250 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Dipharma

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    DIPHARMA FRANCIS SRL

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    MODAFINIL USP

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    16250
    Active
    2002-11-19
    Complete
    2016-07-28
    2016-07-05
    II
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    Looking for Drug Master Files (DMF) for 16250 of Dipharma Francis Srl

    Looking for Drug Master Files (DMF) for 16250 of Dipharma Francis Srl 1

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    Dipharma Francis Srl, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is MODAFINIL USP, with a corresponding US DMF Number 16250.

    Remarkably, this DMF maintains an Active status since its submission on November 19, 2002, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of July 28, 2016, and payment made on July 05, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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