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    List of Drug Master Files (DMF) for 28723 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    01 LURASIDONE HYDROCHLORIDE (1)

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    EDMOND PHARMA SRL

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    LURASIDONE HYDROCHLORIDE

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    28723
    Active
    2014-09-30
    Complete
    2015-07-07
    2014-12-23
    II
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    Looking for Drug Master Files (DMF) for 28723 of Edmond Pharma Srl

    Looking for Drug Master Files (DMF) for 28723 of Edmond Pharma Srl 1

    20

    Edmond Pharma Srl, based in Sweden, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    They are recognized for Recipharm has the brightest minds in the CDMO industry, from early development to commercial manufacturing.

    One of their notable products is LURASIDONE HYDROCHLORIDE, with a corresponding US DMF Number 28723.

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

    Their GDUFA DMF Review was successfully complete, with a review date of July 07, 2015, and payment made on December 23, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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