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    List of Drug Master Files (DMF) for 26676 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    BCN Peptides

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    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    01 NESIRITIDE (1)

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    NESIRITIDE

    PDF Supplier PDF
    URL Supplier Web Content
    26676
    Active
    2012-12-04
    Complete
    2013-03-19
    2013-01-11
    II
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    Looking for Drug Master Files (DMF) for 26676 of Bcn Peptides Sa

    Looking for Drug Master Files (DMF) for 26676 of Bcn Peptides Sa 1

    20

    Bcn Peptides Sa, based in Spain, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is NESIRITIDE, with a corresponding US DMF Number 26676.

    Remarkably, this DMF maintains an Active status since its submission on December 04, 2012, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of March 19, 2013, and payment made on January 11, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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