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華東醫藥(000963.SZ):獲得注射用醋酸卡泊芬淨藥品註冊證書
格隆匯 11-26 16:02

格隆匯11月26日丨華東醫藥(000963.SZ)公佈,近日,公司全資子公司杭州中美華東製藥有限公司(“中美華東”)收到國家藥品監督管理局核准簽發的《藥品註冊證書》(證書編號:2020S00724)。

藥品通用名稱:注射用醋酸卡泊芬浄;英文名/拉丁名:Caspofungin Acetate for Injection;劑型:注射劑;規格:50mg(按C52H88N10O15計);申請事項:藥品註冊(境內生產);註冊分類:原化學藥品第6類;藥品有效期:24個月;上市許可持有人:杭州中美華東製藥有限公司;生產企業:杭州中美華東製藥有限公司;藥品批准文號:國藥準字H20203579;審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,本品符合藥品註冊的有關要求,批准註冊,發給藥品註冊證書。

公司超級抗生素領域產品達託黴素已於2015年上市銷售,此次獲批的注射用醋酸卡泊芬淨成為繼達託黴素後公司第二個獲批上市的超抗藥物,將進一步完善公司在超抗領域的產品結構,有利於提升公司在該領域的市場競爭力,對公司未來業績提升有一定積極作用。公司後續將積極推動注射用醋酸卡泊芬淨的上市銷售工作,同時加快超抗領域後續產品注射用米卡芬淨鈉的註冊上市。

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