华润医药(03320.HK) 公布,集团旗下华润双鹤利民收到国家药监局颁发的法莫替丁注射液《药品补充申请批准通知书》,并视同通过一致性评价。同时,集团旗下双鹤利民获得河南省药品监督管理局颁发的《药品GMP符合性检查告知书》,通过药品GMP符合性检查。
法莫替丁为组织胺H2受体拮抗剂,能够抑制胃酸分泌,该药品主要用于消化性溃疡所致上消化道出血,除肿瘤及食道、胃底静脉曲张以外的各种原因所致的胃及十二指肠粘膜糜烂出血者。根据国家药监局信息显示,内地境内已批准上市的法莫替丁注射液共有46家企业,其中通过或视同通过一致性评价的生产企业21家。另外,双鹤华利新建的生产线E线为首次获批通过GMP符合性检查,C1线及C2线早前已通过GMP符合性检查。(vc/k)(港股报价延迟最少十五分钟。沽空资料截至 2025-01-06 12:25。)
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