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    List of Drug Master Files (DMF) for 31195 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    01 Ercros (1)

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    01 FOSFOMYCIN TROMETHAMINE (1)

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    FOSFOMYCIN TROMETHAMINE

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    31195
    Active
    2017-02-24
    Complete
    2017-06-20
    2016-12-22
    II
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    Looking for Drug Master Files (DMF) for 31195 of Ercros Sa

    Looking for Drug Master Files (DMF) for 31195 of Ercros Sa 1

    20

    Ercros Sa, based in Spain, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is FOSFOMYCIN TROMETHAMINE, with a corresponding US DMF Number 31195.

    Remarkably, this DMF maintains an Active status since its submission on February 24, 2017, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of June 20, 2017, and payment made on December 22, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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