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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
    09/10/2025 BioSpectra
    U.S.A
    		 BIOSPECTRA 31669 UREA ACTIVE PHARMACEUTICAL INGREDIENT 2017-04-24 Active II N/A
    27/09/2025 Cambridge Isotope Laboratories
    U.S.A
    		 CAMBRIDGE ISOTOPE LABORATORIES INC 11378 13C UREA 1995-03-16 Active II N/A