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    List of Drug Master Files (DMF) for 24901 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    F.I.S. Fabbrica Italiana Sintetici

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    01 F.I.S. Fabbrica Italiana Sintetici (1)

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    01 ESOMEPRAZOLE MAGNESIUM DIHYDRATE (1)

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    FIS FABBRICA ITALIANA SINTETICI SPA

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    ESOMEPRAZOLE MAGNESIUM DIHYDRATE

    PDF Supplier PDF
    URL Supplier Web Content
    24901
    Active
    2011-04-20
    Complete
    2014-05-05
    2013-04-05
    II
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    Looking for Drug Master Files (DMF) for 24901 of Fis Fabbrica Italiana Sintetici Spa

    Looking for Drug Master Files (DMF) for 24901 of Fis Fabbrica Italiana Sintetici Spa 1

    20

    Fis Fabbrica Italiana Sintetici Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is ESOMEPRAZOLE MAGNESIUM DIHYDRATE, with a corresponding US DMF Number 24901.

    Remarkably, this DMF maintains an Active status since its submission on April 20, 2011, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of May 05, 2014, and payment made on April 05, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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