國藥現代(600420.SH):阿莫西林膠囊通過仿製藥一致性評價
格隆匯6月20日丨國藥現代(600420.SH)公佈,近日,公司全資子公司國藥金石收到國家藥品監督管理局核准簽發的阿莫西林膠囊(0.5g)《藥品補充申請批准通知書》,批准該藥品通過仿製藥質量和療效一致性評價(簡稱“一致性評價”)。
阿莫西林適用於敏感菌所致的成人與兒童的中耳炎、鼻竇炎、咽炎、扁桃體炎等上呼吸道感染;泌尿生殖道感染;皮膚軟組織感染;急性支氣管炎等下呼吸道感染;與其他藥物聯用根除幽門螺桿菌。
根據米內網數據庫顯示,阿莫西林膠囊2021年度全國公立醫院銷售額總計約人民幣7.61億元。
CDE網站顯示,目前阿莫西林膠囊通過/視同通過一致性評價的企業還有廣州白雲山醫藥集團股份有限公司白雲山製藥總廠、海南海力製藥有限公司、四川峨嵋山藥業有限公司、哈藥集團製藥總廠等。截止目前,國藥金石用於開展阿莫西林膠囊(0.5g)一致性評價累計研發投入約人民幣682萬元(未經審計)。
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