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    List of Drug Master Files (DMF) for 17113 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 HYDROXYPROGESTERONE CAPROATE (1)

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    01 Netherlands (1)

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    ASPEN OSS BV

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    HYDROXYPROGESTERONE CAPROATE

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    URL Supplier Web Content
    17113
    Active
    2004-01-21
    Complete
    2017-02-01
    2017-01-09
    II
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    Looking for Drug Master Files (DMF) for 17113 of Aspen Oss Bv

    Looking for Drug Master Files (DMF) for 17113 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 HYDROXYPROGESTERONE CAPROATE, with a corresponding US DMF Number 17113.

    Remarkably, this DMF maintains an Active status since its submission on January 21, 2004, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of February 01, 2017, and payment made on January 09, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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