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    Fresenius Kabi AB Brunna

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    Fresenius Kabi Ipsum Srl

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2024-02-12

    Pay. Date : 2023-12-18

    DMF Number : 38741

    Submission : 2023-12-11

    Status : Active

    Type : II

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    Looking for Drug Master Files (DMF) for 38741 of Fresenius Kabi Ipsum Srl

    Looking for Drug Master Files (DMF) for 38741 of Fresenius Kabi Ipsum Srl 1

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    Fresenius Kabi Ipsum Srl, based in Sweden, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is CEFTAZIDIME PENTAHYDRATE STERILE BUFFERED / AVIBACTAM SODIUM STERILE (4:1), with a corresponding US DMF Number 38741.

    Remarkably, this DMF maintains an Active status since its submission on December 11, 2023, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of February 12, 2024, and payment made on December 18, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II