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    List of Drug Master Files (DMF) for 14718 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Cerbios-Pharma SA

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    CALCITRIOL

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    14718
    Active
    2000-02-18
    Complete
    2014-01-22
    2012-12-18
    II
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    Looking for Drug Master Files (DMF) for 14718 of Cerbios Pharma Sa

    Looking for Drug Master Files (DMF) for 14718 of Cerbios Pharma Sa 1

    20

    Cerbios Pharma Sa, based in Switzerland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    They are recognized for Cerbios offers CDMO services for HPAPIs, ADCs & recombinant proteins & is active in the field of generic APIs & probiotics (SF68®).

    One of their notable products is CALCITRIOL, with a corresponding US DMF Number 14718.

    Remarkably, this DMF maintains an Active status since its submission on February 18, 2000, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of January 22, 2014, and payment made on December 18, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II

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