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    List of Drug Master Files (DMF) for 6914 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    01 BENZTROPINE MESYLATE (1)

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    FINE CHEMICALS CORP PTY LTD

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    BENZTROPINE MESYLATE

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    6914
    Active
    1987-04-09
    Complete
    2012-10-25
    2012-12-19
    II
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    Looking for Drug Master Files (DMF) for 6914 of Fine Chemicals Corp Pty Ltd

    Looking for Drug Master Files (DMF) for 6914 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 BENZTROPINE MESYLATE, with a corresponding US DMF Number 6914.

    Remarkably, this DMF maintains an Active status since its submission on April 09, 1987, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of October 25, 2012, and payment made on December 19, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II

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