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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 Nippon Fine Chemical
Japan
NIPPON FINE CHEMICAL CO LTD 24780 A LIPOSOMAL EXCIPIENT CHOLESTEROL HP 2011-03-18 Active IV N/A
28/03/2025 Xiamen SINOPEG Biotech
China
XIAMEN SINOPEG BIOTECH CO LTD 38440 (3S,8S,9S,10R,13R,14S,17R)-10,13-DIMETHYL-17-((R)-6-METHYLHEPTAN-2-YL)-2,3,4,7,8,9,10,11,12,13,14,15,16,17-TETRADECAHYDRO-1H-CYCLOPENTA[A]PHENANTHREN-3-OL(CHOLESTEROL) 2023-05-30 Active IV N/A