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    List of Drug Master Files (DMF) for 18297 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    AMINO CHEMICALS LTD

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    PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

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    18297
    Active
    2005-04-21
    Complete
    2019-04-12
    2019-02-19
    II
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    Looking for Drug Master Files (DMF) for 18297 of Amino Chemicals Ltd

    Looking for Drug Master Files (DMF) for 18297 of Amino Chemicals Ltd 1

    20

    Amino Chemicals Ltd, based in Malta, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE, with a corresponding US DMF Number 18297.

    Remarkably, this DMF maintains an Active status since its submission on April 21, 2005, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of April 12, 2019, and payment made on February 19, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II

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