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    List of Drug Master Files (DMF) for 24528 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 ELETRIPTAN HYDROBROMIDE (1)

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    FIS FABBRICA ITALIANA SINTETICI SPA

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    ELETRIPTAN HYDROBROMIDE

    PDF Supplier PDF
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    24528
    Active
    2010-12-29
    Complete
    2013-12-18
    2013-10-25
    II
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    Looking for Drug Master Files (DMF) for 24528 of Fis Fabbrica Italiana Sintetici Spa

    Looking for Drug Master Files (DMF) for 24528 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 ELETRIPTAN HYDROBROMIDE, with a corresponding US DMF Number 24528.

    Remarkably, this DMF maintains an Active status since its submission on December 29, 2010, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of December 18, 2013, and payment made on October 25, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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