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    List of Drug Master Files (DMF) for 32197 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 ERLOTINIB HYDROCHLORIDE (1)

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    FIS FABBRICA ITALIANA SINTETICI SPA

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    ERLOTINIB HYDROCHLORIDE

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    32197
    Active
    2017-12-18
    Complete
    2018-03-22
    2017-10-31
    II
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    Looking for Drug Master Files (DMF) for 32197 of Fis Fabbrica Italiana Sintetici Spa

    Looking for Drug Master Files (DMF) for 32197 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 ERLOTINIB HYDROCHLORIDE, with a corresponding US DMF Number 32197.

    Remarkably, this DMF maintains an Active status since its submission on December 18, 2017, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of March 22, 2018, and payment made on October 31, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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