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    List of Drug Master Files (DMF) for 28808 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 LEUPRORELIN HIGHLY PURIFIED (1)

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    ASPEN OSS BV

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    Virtual BoothAspen API. More than just an API.
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    LEUPRORELIN HIGHLY PURIFIED

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    28808
    Active
    2014-11-06
    Complete
    2021-06-29
    2020-11-09
    II
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    Looking for Drug Master Files (DMF) for 28808 of Aspen Oss Bv

    Looking for Drug Master Files (DMF) for 28808 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 LEUPRORELIN HIGHLY PURIFIED, with a corresponding US DMF Number 28808.

    Remarkably, this DMF maintains an Active status since its submission on November 06, 2014, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of June 29, 2021, and payment made on November 09, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II

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