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    List of Drug Master Files (DMF) for 13971 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    01 GANIRELIX (1)

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    ASPEN OSS BV

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    Virtual BoothAspen API. More than just an API.
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    GANIRELIX

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    URL Supplier Web Content
    13971
    Active
    1999-02-04
    Complete
    2024-03-07
    2024-03-05
    II
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    Looking for Drug Master Files (DMF) for 13971 of Aspen Oss Bv

    Looking for Drug Master Files (DMF) for 13971 of Aspen Oss Bv 1

    20

    Aspen Oss Bv, based in Netherlands, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    They are recognized for Aspen API. More than just an API.

    One of their notable products is GANIRELIX, with a corresponding US DMF Number 13971.

    Remarkably, this DMF maintains an Active status since its submission on February 04, 1999, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of March 07, 2024, and payment made on March 05, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II

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