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

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    Gadoteridol

    ACTIVE PHARMA INGREDIENTS

    INTERMEDIATES

    FINISHED DOSAGE FORMULATIONS

    RELATED EXCIPIENT COMPANIES

    EXCIPIENTS BY APPLICATIONS

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    Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
    26/09/2024 Biophore India Pharmaceuticals Pvt Ltd
    India
    		 BIOPHORE INDIA PHARMACEUTICALS PVT LTD 35047 GADOTERIDOL 2020-07-31 Active II Complete 2020-11-03 2020-09-24
    26/09/2024 Hainan Poly Pharm
    China
    		 ANHUI POLY PHARM CO LTD 37960 GADOTERIDOL USP 2023-02-09 Active II Complete 2023-03-21 2023-02-03