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    List of Drug Master Files (DMF) for 24728 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 CLOBAZAM (1)

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    FIS FABBRICA ITALIANA SINTETICI SPA

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    CLOBAZAM

    PDF Supplier PDF
    URL Supplier Web Content
    24728
    Active
    2011-02-28
    Complete
    2015-10-02
    2015-03-11
    II
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    Looking for Drug Master Files (DMF) for 24728 of Fis Fabbrica Italiana Sintetici Spa

    Looking for Drug Master Files (DMF) for 24728 of Fis Fabbrica Italiana Sintetici Spa 1

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    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 CLOBAZAM, with a corresponding US DMF Number 24728.

    Remarkably, this DMF maintains an Active status since its submission on February 28, 2011, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of October 02, 2015, and payment made on March 11, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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