天士力(600535.SH):子公司鹽酸美金剛緩釋膠囊獲得藥品註冊證書
格隆匯12月20日丨天士力(600535.SH)公佈,近日,公司全資子公司江蘇天士力帝益藥業有限公司(“帝益藥業”)收到國家藥品監督管理局核准簽發的鹽酸美金剛緩釋膠囊《藥品註冊證書》。
鹽酸美金剛為新型N-甲基-D-天冬氨酸(NMDA)受體拮抗劑,具有保護神經細胞功能以及促進認知功能恢復的作用。鹽酸美金剛緩釋膠囊(28mg/7mg)原研藥的持證商為ForestLaboratoriesLLC,於2010年6月獲得FDA批准上市,商品名為NamendaXR®。公司仿製藥與NamendaXR®質量和療效一致。
米內網化學藥醫療終端數據顯示國內城市公立、縣級公立鹽酸美金剛相關產品2020年銷售額為5.94億元(均為普通片和口服液)。鹽酸美金剛緩釋膠囊於2020年11月在國內首次獲批上市,截至目前包括公司在內共有5家企業獲批生產鹽酸美金剛緩釋膠囊。
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