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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
25/04/2025 Pfanstiehl
U.S.A
PFANSTIEHL INC 39584 TRIS HYDROCHLORIDE, HIGH PURITY, LOW ENDOTOXIN, LOW METALS (T-154) 2024-03-01 Active IV N/A
25/04/2025 BioSpectra
U.S.A
BIOSPECTRA 31921 TRIS HCI 2017-08-09 Active IV N/A