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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
28/03/2025 Minakem (formerly Delmar Chemicals)
Canada
DELMAR CHEMICALS INC 32140 SORAFENIB HEMITOSYLATE 2017-12-20 Active II Complete 2018-07-27 2018-01-19
28/03/2025 Granules India Limited
India
GRANULES INDIA LTD 37229 SORAFENIB TOSYLATE USP 2022-06-30 Active II N/A