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    List of Drug Master Files (DMF) for 27898 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Amsa Spa

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

    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    01 LURASIDONE HYDROCHLORIDE (1)

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    LURASIDONE HYDROCHLORIDE

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    27898
    Active
    2014-04-30
    Complete
    2014-06-24
    2014-01-24
    II
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    Looking for Drug Master Files (DMF) for 27898 of Amsa Spa

    Looking for Drug Master Files (DMF) for 27898 of Amsa Spa 1

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    Amsa Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA.

    One of their notable products is LURASIDONE HYDROCHLORIDE, with a corresponding US DMF Number 27898.

    Remarkably, this DMF maintains an Active status since its submission on April 30, 2014, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of June 24, 2014, and payment made on January 24, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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