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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
29/11/2025 Jiangsu Hengrui Medicine
China
JIANGSU HENGRUI PHARMACEUTICALS CO LTD 34108 IOVERSOL USP, NON-STERILE, BULK DRUG SUBSTANCE 2019-09-30 Inactive II N/A
29/11/2025 Mallinckrodt Pharmaceuticals
Ireland
SPECGX LLC 6972 IOVERSOL 1987-05-13 Active II N/A