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    List of Drug Master Files (DMF) for 28106 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    01 REMIFENTANIL HYDROCHLORIDE (1)

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    FINE CHEMICALS CORP PTY LTD

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    Virtual BoothAspen API. More than just an API.
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    REMIFENTANIL HYDROCHLORIDE

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    URL Supplier Web Content
    28106
    Active
    2014-03-13
    Complete
    2015-03-30
    2014-12-04
    II
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    Looking for Drug Master Files (DMF) for 28106 of Fine Chemicals Corp Pty Ltd

    Looking for Drug Master Files (DMF) for 28106 of Fine Chemicals Corp Pty Ltd 1

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    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 REMIFENTANIL HYDROCHLORIDE, with a corresponding US DMF Number 28106.

    Remarkably, this DMF maintains an Active status since its submission on March 13, 2014, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of March 30, 2015, and payment made on December 04, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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