博瑞醫藥(688166.SH)子公司獲得阿尼芬淨原料藥韓國註冊證書
格隆匯12月6日丨博瑞醫藥(688166.SH)公佈,近日,公司子公司信泰制藥(蘇州)有限公司收到韓國食品藥品管理局(“MFDS”)核准簽發的“阿尼芬淨原料藥”韓國註冊證書。
本品為除原研輝瑞製藥公司獲批的阿尼芬淨原料藥外第二家在韓國獲得批準的阿尼芬淨原料藥。
注射用阿尼芬淨的適應症為:1 念珠菌血症及其他類型的念珠菌感染(腹腔膿腫、腹膜炎);2 食管念珠菌。
此次子公司獲得MFDS批准的原料藥註冊證書,顯示韓國規範市場對該原料藥質量的認可和肯定,標誌着該原料藥產品可以在韓國市場進行銷售。本品不會對公司近期業績造成重大影響。
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