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    List of Drug Master Files (DMF) for 3823 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    01 Aspen API (1)

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    01 PROGESTERONE (1)

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    ASPEN OSS BV

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    • FDA
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    Virtual BoothAspen API. More than just an API.
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    PROGESTERONE

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    URL Supplier Web Content
    3823
    Active
    1980-05-20
    Complete
    2019-05-14
    2019-05-09
    II
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    CPhI North America

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    Looking for Drug Master Files (DMF) for 3823 of Aspen Oss Bv

    Looking for Drug Master Files (DMF) for 3823 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 PROGESTERONE, with a corresponding US DMF Number 3823.

    Remarkably, this DMF maintains an Active status since its submission on May 20, 1980, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of May 14, 2019, and payment made on May 09, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II

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