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    List of Drug Master Files (DMF) for 25316 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    01 SCOPOLAMINE (HYOSCINE) (1)

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    FINE CHEMICALS CORP PTY LTD

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    SCOPOLAMINE (HYOSCINE)

    PDF Supplier PDF
    URL Supplier Web Content
    25316
    Active
    2011-09-22
    Complete
    2019-05-30
    2019-05-24
    II
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    Looking for Drug Master Files (DMF) for 25316 of Fine Chemicals Corp Pty Ltd

    Looking for Drug Master Files (DMF) for 25316 of Fine Chemicals Corp Pty Ltd 1

    20

    Fine Chemicals Corp Pty Ltd, 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 SCOPOLAMINE (HYOSCINE), with a corresponding US DMF Number 25316.

    Remarkably, this DMF maintains an Active status since its submission on September 22, 2011, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of May 30, 2019, and payment made on May 24, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II

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