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    List of Drug Master Files (DMF) for 31569 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    EDMOND PHARMA SRL

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    ISOPROTERENOL HYDROCHLORIDE

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    31569
    Active
    2017-05-15
    Complete
    2017-07-26
    2017-05-31
    II
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    Looking for Drug Master Files (DMF) for 31569 of Edmond Pharma Srl

    Looking for Drug Master Files (DMF) for 31569 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 ISOPROTERENOL HYDROCHLORIDE, with a corresponding US DMF Number 31569.

    Remarkably, this DMF maintains an Active status since its submission on May 15, 2017, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of July 26, 2017, and payment made on May 31, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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