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    List of Drug Master Files (DMF) for 6309 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    01 THIOTHIXENE (1)

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    FINE CHEMICALS CORP PTY LTD

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    • FDA
    • EDQM
    Virtual BoothAspen API. More than just an API.
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    THIOTHIXENE

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    URL Supplier Web Content
    6309
    Active
    1986-05-05
    Complete
    2019-09-26
    2019-09-13
    II
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    Looking for Drug Master Files (DMF) for 6309 of Fine Chemicals Corp Pty Ltd

    Looking for Drug Master Files (DMF) for 6309 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 THIOTHIXENE, with a corresponding US DMF Number 6309.

    Remarkably, this DMF maintains an Active status since its submission on May 05, 1986, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of September 26, 2019, and payment made on September 13, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II

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