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    List of Drug Master Files (DMF) for 29584 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 DORZOLAMIDE HYDROCHLORIDE (ALTERNATIVE PROCESS) (1)

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    FIS FABBRICA ITALIANA SINTETICI SPA

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    DORZOLAMIDE HYDROCHLORIDE (ALTERNATIVE PROCESS)

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    29584
    Active
    2015-07-24
    Complete
    2018-06-13
    2017-11-21
    II
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    Looking for Drug Master Files (DMF) for 29584 of Fis Fabbrica Italiana Sintetici Spa

    Looking for Drug Master Files (DMF) for 29584 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 DORZOLAMIDE HYDROCHLORIDE (ALTERNATIVE PROCESS), with a corresponding US DMF Number 29584.

    Remarkably, this DMF maintains an Active status since its submission on July 24, 2015, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of June 13, 2018, and payment made on November 21, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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