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    List of Drug Master Files (DMF) for 28820 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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    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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    TIOTROPIUM BROMIDE

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    28820
    Active
    2015-01-27
    Complete
    2015-09-03
    2015-02-05
    II
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    Looking for Drug Master Files (DMF) for 28820 of Cerbios Pharma Sa

    Looking for Drug Master Files (DMF) for 28820 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 TIOTROPIUM BROMIDE, with a corresponding US DMF Number 28820.

    Remarkably, this DMF maintains an Active status since its submission on January 27, 2015, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of September 03, 2015, and payment made on February 05, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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