美諾華(603538.SH):纈沙坦(原料藥)順利通過中國藥品GMP認證
格隆匯11月7日丨美諾華(603538.SH)公佈,近日,公司控股子公司浙江美諾華藥物化學有限公司(“浙江美諾華”)收到浙江省藥品監督管理局簽發的纈沙坦(原料藥)《藥品GMP證書》。
纈沙坦是一種非肽類的血管緊張素II受體拮抗劑(ARB),能選擇性地阻斷AngII與AT1受體的結合,從而抑制血管收縮和醛固酮的釋放,產生降壓作用,由瑞士諾華公司開發成功後,首先在德國上市,1997年獲得FDA批准。主要用於抗高血壓、輕中度原發性高血壓,尤其適用腎臟損害所致繼發性高血壓。
纈沙坦(原料藥)為公司的重點產品之一,此次纈沙坦(原料藥)順利通過中國藥品GMP認證,説明公司該原料藥產品的質量管理體系已符合中國藥品GMP標準,對公司進一步開拓國內市場、提升主要產品的市場佔有率具有積極影響。
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