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    List of Drug Master Files (DMF) for 5046 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    LEUCOVORIN CALCIUM

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    5046
    Active
    1983-06-30
    Complete
    2013-10-04
    2013-09-25
    II
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    Looking for Drug Master Files (DMF) for 5046 of Cerbios Pharma Sa

    Looking for Drug Master Files (DMF) for 5046 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 LEUCOVORIN CALCIUM, with a corresponding US DMF Number 5046.

    Remarkably, this DMF maintains an Active status since its submission on June 30, 1983, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of October 04, 2013, and payment made on September 25, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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