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    List of Drug Master Files (DMF) for 26716 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    01 BCN Peptides (1)

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    01 LEUPROLIDE (LEUPRORELIN) (1)

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    LEUPROLIDE (LEUPRORELIN)

    PDF Supplier PDF
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    26716
    Active
    2012-12-11
    Complete
    2021-01-28
    2021-01-22
    II
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    Looking for Drug Master Files (DMF) for 26716 of Bcn Peptides Sa

    Looking for Drug Master Files (DMF) for 26716 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 LEUPROLIDE (LEUPRORELIN), with a corresponding US DMF Number 26716.

    Remarkably, this DMF maintains an Active status since its submission on December 11, 2012, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of January 28, 2021, and payment made on January 22, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II

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