海正藥業(600267.SH)全資子公司鹽酸莫西沙星原料藥獲CEP證書
格隆匯7月22日丨海正藥業(600267.SH)公佈,近日,公司全資子公司海正藥業(南通)有限公司(簡稱“海正南通公司”)收到歐洲藥品質量管理局(European Directorate forthe Quality of Medicines & Health Care,以下簡稱“EDQM”)簽發的鹽酸莫西沙星原料藥歐洲藥典適用性認證證書(Certificate of Suitability to Monograph of European Pharmacopoeia,以下簡稱“CEP證書”)。
鹽酸莫西沙星片適用於治療上呼吸道和下呼吸道感染,也屬於抗結核的二線藥品。目前,國內外鹽酸莫西沙星原料藥的主要生產、銷售廠家有BAYERPHARMA、KRKA、四川國為製藥有限公司、南京優科製藥有限公司等。據統計,鹽酸莫西沙星原料藥2019年的全球銷售量約為93,897.1134公斤,2020年1-3月的全球銷售量約為27,045.1992公斤(數據來源IMS)。
海正南通公司於2018年10月31日向EDQM提交了鹽酸莫西沙星原料藥的CEP申請,並於2020年7月16日獲得批准。截至目前,公司在該藥品研發項目上已投入約1209萬元人民幣。
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