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    List of Drug Master Files (DMF) for 31739 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 ENCLOMIPHENE CITRATE (1)

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    FIS FABBRICA ITALIANA SINTETICI SPA

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    ENCLOMIPHENE CITRATE

    PDF Supplier PDF
    URL Supplier Web Content
    31739
    Active
    2017-05-25
    Complete
    2017-12-15
    2017-05-11
    II
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    Looking for Drug Master Files (DMF) for 31739 of Fis Fabbrica Italiana Sintetici Spa

    Looking for Drug Master Files (DMF) for 31739 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 ENCLOMIPHENE CITRATE, with a corresponding US DMF Number 31739.

    Remarkably, this DMF maintains an Active status since its submission on May 25, 2017, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of December 15, 2017, and payment made on May 11, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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