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    List of Drug Master Files (DMF) for 20654 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 ROPIVACAINE HYDROCHLORIDE (1)

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    FINE CHEMICALS CORP PTY LTD

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    • EDQM
    Virtual BoothAspen API. More than just an API.
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    ROPIVACAINE HYDROCHLORIDE

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    URL Supplier Web Content
    20654
    Active
    2007-07-03
    Complete
    2016-12-19
    2016-11-18
    II
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    Booth #548

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    Looking for Drug Master Files (DMF) for 20654 of Fine Chemicals Corp Pty Ltd

    Looking for Drug Master Files (DMF) for 20654 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 ROPIVACAINE HYDROCHLORIDE, with a corresponding US DMF Number 20654.

    Remarkably, this DMF maintains an Active status since its submission on July 03, 2007, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of December 19, 2016, and payment made on November 18, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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