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現代製藥(600420.SH):國藥威奇達阿莫西林原料藥獲得CEP證書
格隆匯 07-24 15:58

格隆匯 7 月 24日丨現代製藥(600420.SH)公佈,近日,公司全資子公司國藥集團威奇達藥業有限公司(“國藥威奇達”)收到歐洲藥品質量管理局(“EDQM”)簽發的阿莫西林原料藥歐洲藥典適用性認證證書(“CEP證書”)。

藥物名稱:Amoxicillin trihydrate/阿莫西林(三水化合物)原料藥;藥品生產商/持有人:國藥集團威奇達藥業有限公司;證書編號:R0-CEP2019-244-Rev00;發證機構:歐洲藥品質量管理局(EDQM);有效期:自2020年7月23日起五年內有效。

阿莫西林是一種最常用的半合成青黴素類廣譜β-內酰胺類抗生素,是目前應用較為廣泛的口服半合成青黴素之一,其製劑有膠囊、片劑、顆粒劑、分散片等,主要適用於溶血鏈球菌、肺炎鏈球菌、葡萄球菌或流感嗜血桿菌所致的咽炎、扁桃體炎、急性支氣管炎、肺炎等。

目前,阿莫西林原料藥國內主要生產廠商有國藥集團威奇達藥業有限公司、珠海聯邦制藥股份有限公司等。公司未能從公開渠道查詢到阿莫西林原料藥的全球銷售數據。

國藥威奇達於2019年9月26日向EDQM提交阿莫西林原料藥CEP申請,於2020年7月23日獲得CEP證書。

此次國藥威奇達阿莫西林原料藥獲得CEP證書,表明該原料藥符合歐洲藥典的質量要求,顯示歐洲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歐洲市場及承認CEP證書的加拿大、澳大利亞等其他市場進行銷售,為子公司進一步拓展國際市場帶來積極的影響。此次獲得CEP證書不會對公司當期經營業績產生重大影響。

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