九典制藥(300705.SZ):鹽酸普拉克索緩釋片獲批上市
格隆匯9月9日丨九典制藥(300705.SZ)公佈,公司近日收到國家藥監局下發的關於鹽酸普拉克索緩釋片的《藥品註冊證書》。鹽酸普拉克索作為一種新型多巴胺促受體激動劑,可治療各期帕金森病。
截至該公吿日,鹽酸普拉克索緩釋片(0.375mg)國內共有13家(含公司和原研)企業取得了藥品註冊證書,鹽酸普拉克索緩釋片(0.75mg)國內共有8家(含公司和原研)企業取得了藥品註冊證書。公司該品種的兩個規格均按照新註冊分類4申報,分別為國內第13家、第8家通過或視同通過仿製藥質量和療效一致性評價的企業。
上述藥品註冊證書的取得進一步豐富了公司製劑產品品種,對進一步優化公司產品結構有着積極意義。
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