浙江醫藥(600216.SH):子公司昌海製藥通過美國FDA現場檢查
格隆匯2月17日丨浙江醫藥(600216.SH)公佈,公司控股子公司浙江昌海製藥有限公司(“昌海製藥”)於2020年11月02日-06日接受了來自美國食品藥品監督管理局(“FDA”)的cGMP(現行藥品生產質量管理規範)現場檢查,涉及產品為達託黴素原料藥。
2021年2月11日,昌海製藥收到FDA的通知函和針對此次檢查簽發的現場檢查報吿(EIR),按照美國21 CFR法規(美國聯邦法規第21章)規定,FDA確認此次檢查已結束。該通知説明昌海製藥的質量管理體系符合美國FDA的標準,順利通過了此次美國FDA的批准前現場檢查。
通過此次FDA現場檢查的為昌海製藥達託黴素原料藥生產線,設計最大產能為2噸/年,累計研發投入約人民幣2780萬元。
達託黴素適用於金黃色葡萄球菌(包括甲氧西林耐藥菌株等)、化膿鏈球菌無乳鏈球菌等導致的複雜性皮膚及軟組織感染、伴發右側感染性心內膜炎的血流感染的治療。達託黴素原料藥國內主要生產廠商有麗珠集團福州福興醫藥有限公司、浙江醫藥股份有限公司新昌製藥廠等。經查詢,達託黴素2019年全球原料藥銷售量約為2638公斤,製劑銷售額約為7.13億美元;其中美國市場原料藥銷售量約為1708公斤,製劑銷售額約為5.09億美元(數據來源於Cortellis數據庫)。
此次昌海製藥順利通過美國FDA檢查,提升了公司原料藥的國際競爭力,為其他產品推向國際市場奠定了堅實的基礎,為今後進一步加強國際合作創造了更為有利的先決條件。
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