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    List of Drug Master Files (DMF) for 26016 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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    (6S)-5-METHYLTETRAHYDROFOLIC ACID CALCIUM SALT

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    26016
    Active
    2012-04-30
    Complete
    2016-10-21
    2016-08-31
    II
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    Looking for Drug Master Files (DMF) for 26016 of Cerbios Pharma Sa

    Looking for Drug Master Files (DMF) for 26016 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 (6S)-5-METHYLTETRAHYDROFOLIC ACID CALCIUM SALT, with a corresponding US DMF Number 26016.

    Remarkably, this DMF maintains an Active status since its submission on April 30, 2012, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of October 21, 2016, and payment made on August 31, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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