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    List of Drug Master Files (DMF) for 25044 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    CURIA SPAIN SAU

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    OLOPATADINE HYDROCHLORIDE, USP (PROCESS II)

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    25044
    Active
    2011-06-13
    Complete
    2013-06-25
    2012-12-24
    II
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    Looking for Drug Master Files (DMF) for 25044 of Curia Spain Sau

    Looking for Drug Master Files (DMF) for 25044 of Curia Spain Sau 1

    20

    Curia Spain Sau, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

    They are recognized for Curia- A partner for the pharma and biotech industries to improve patient outcomes & quality of life.

    One of their notable products is OLOPATADINE HYDROCHLORIDE, USP (PROCESS II), with a corresponding US DMF Number 25044.

    Remarkably, this DMF maintains an Active status since its submission on June 13, 2011, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of June 25, 2013, and payment made on December 24, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II

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