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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 6492 PENTAMIDINE ISETHIONATE 1986-07-23 Active II Complete 2014-03-31 2013-09-17
28/03/2025 Sanofi
France
RHONE POULENC RORER INC 6288 PENTAMIDINE ISETHIONATE 1985-12-13 Inactive II N/A