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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 |