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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
24/02/2025 SPI Pharma
U.S.A
SPI PHARMA INC 16037 PHARMABURST® B SERIES PRODUCTS 2002-07-03 Active IV N/A
24/02/2025 Pfanstiehl
U.S.A
PFANSTIEHL INC 32464 D-MANNITOL (PLANT DERIVED) HIGH PURITY / LOW ENDOTOXIN-LOW METALS USP/EP/JP/CHP (M-109-7) 2018-02-15 Active IV N/A