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    List of Drug Master Files (DMF) for 32872 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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    AMINO CHEMICALS LTD

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    PRAMIPEXOLE BASE

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    32872
    Active
    2018-11-07
    Complete
    2019-05-30
    2018-09-14
    II
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    Looking for Drug Master Files (DMF) for 32872 of Amino Chemicals Ltd

    Looking for Drug Master Files (DMF) for 32872 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 BASE, with a corresponding US DMF Number 32872.

    Remarkably, this DMF maintains an Active status since its submission on November 07, 2018, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of May 30, 2019, and payment made on September 14, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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