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現代製藥(600420.SH):國藥三益通過藥品生產質量管理規範符合性檢查
格隆匯 12-23 15:25

格隆匯12月23日丨現代製藥(600420.SH)公佈,近日,公司控股公司國藥集團三益藥業(蕪湖)有限公司(“國藥三益”)收到安徽省藥品監督管理局發的《檢查結果通知》,安徽省藥品監督管理局對國藥三益進行現場檢查後(檢查範圍:溶液劑(外用)、滴鼻劑、滴耳劑(溶液劑車間2))認為此次檢查結果符合《藥品生產質量管理規範(2010年修訂)》的要求。

通過藥品生產質量管理規範(“GMP”)符合性檢查的車間主要生產滴鼻劑、滴耳劑、外用溶液劑,設計產能為2000萬支/年。主要產品鹽酸萘甲唑啉滴鼻液、硼酸冰片滴耳液、開塞露。該車間為在原生產地址就原生產範圍新建的溶液劑車間(2)。

次通過GMP符合性檢查的車間所生產的鹽酸萘甲唑啉滴鼻液用於過敏性及炎症性鼻充血急慢性鼻炎;硼酸冰片滴耳液為耳內消炎止痛藥用於耳底耳塞耳內流黃水等;開塞露用於便祕。

2018年國藥三益生產的鹽酸萘甲唑啉滴鼻液銷售收入為2,638萬元,硼酸冰片滴耳液銷售收入為197萬元,開塞露銷售收入為64萬元。

根據藥品管理法》及國家藥品監督管理局發佈的《關於貫徹實施<中華人民共和國藥品管理法>有關事項的公告》(2019年第103號)相關規定,2019121日起,取消藥品GMP認證,不再發放藥品GMP證書。凡現行法規要求進行現場檢查的,2019121日後繼續開展現場檢查,將現場檢查結果通知企業。

此次國藥三益申請並通過GMP符合性檢查表明國藥三益相關生產線符合《藥品生產質量管理規範(2010年修訂)》的要求,有利於國藥三益繼續保持穩定的產品質量和生產能力,從而滿足市場需求。此次通過GMP符合性檢查事項將不會對公司業績產生重大影響。

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