華海藥業(600521.SH):纈沙坦原料藥通過歐盟官方cGMP遠程審計
格隆匯1月26日丨華海藥業(600521.SH)公佈,2021年09月23日至2021年09月30日,公司接受了歐洲藥品質量管理局(EDQM)及意大利藥品監管局(AIFA)聯合檢查組(“歐盟官方”)的cGMP(現行藥品生產質量管理規範)遠程審計。
近日,公司收到歐盟官方針對纈沙坦原料藥的GMP證書和檢查報吿,歐盟官方確認:浙江華海藥業股份有限公司川南原料藥生產基地符合歐盟cGMP質量體系要求。
本次歐盟官方cGMP審計主要涉及公司川南生產基地原料藥生產線,涉及的產品為纈沙坦原料藥。
纈沙坦為主要用於治療高血壓的原料藥,全球主要生產廠商有Aurobindo Pharma Ltd、Lupin Ltd 等。根據newport數據庫顯示,2020年10月—2021年9月,該藥品全球銷售額約72.21億美元,其中歐盟市場銷售額約18.77億美元。
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