药明生物再次通过日本PMDA GMP检查累计通过42次全球药品监管机构检查

美通社2025-02-27

无锡2025年2月27日 /美通社/ -- 全球领先的合同研究、开发和生产（CRDMO）服务公司药明生物（WuXi Biologics, 2269.HK）宣布，公司无锡基地的生物药原液生产厂（MFG2和MFG5）再次通过日本药品医疗器械综合机构（PMDA）GMP检查。公司以零缺陷通过此次涵盖设施质量体系及生产全流程的现场检查，彰显了其在满足全球监管要求方面的卓越能力。截至目前，药明生物已累计成功...

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2269.HK）宣布，公司无锡基地的生物药原液生产厂（MFG2和MFG5）再次通过日本药品医疗器械综合机构（PMDA）GMP检查。公司以零缺陷通过此次涵盖设施质量体系及生产全流程的现场检查，彰显了其在满足全球监管要求方面的卓越能力。 截至目前，药明生物已累计成功...</p>\n\n<a href=\"https://wwwold.prnasia.com/story/archive/4628886_ZH28886_1\">网页链接</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK1576","symbol_name":"医药外包概念","start_time":0,"source_url":"https://wwwold.prnasia.com/story/archive/4628886_ZH28886_1","article_id":"2514849719","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2514849719","pubTimestamp":1740630600,"columns":[],"sourceInfo":{"source_id":"prnasia","name":"美通社"},"weMediaInfo":null,"summary":"无锡2025年2月27日 /美通社/ 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again passed Japan's PMDA GMP inspection and passed a total of 42 global drug regulatory agency inspections","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"WXXWY":0.9,"02269":0.9,"ESG":1},"content_text":"无锡2025年2月27日 /美通社/ -- 全球领先的合同研究、开发和生产（CRDMO）服务公司药明生物（WuXi Biologics, 2269.HK）宣布，公司无锡基地的生物药原液生产厂（MFG2和MFG5）再次通过日本药品医疗器械综合机构（PMDA）GMP检查。公司以零缺陷通过此次涵盖设施质量体系及生产全流程的现场检查，彰显了其在满足全球监管要求方面的卓越能力。 截至目前，药明生物已累计成功通过42次全球药品监管机构检查，并获得美国、欧洲、中国、新加坡、日本及加拿大等国家和地区药监部门颁发的97项生产许可证。这些持续出色的监管检查成绩充分证明了公司稳定可靠的质量体系完全符合全球标准。 药明生物首席执行官陈智胜博士表示：\"世界一流的质量体系是我们可持续发展的基石，也为全球生产基地服务各国客户筑牢根基。药明生物将继续赋能全球合作伙伴加速开发和生产创新生物药，造福广大病患。\" 关于药明生物 药明生物（股票代码：2269.HK）是一家全球领先的合同研究、开发和生产（CRDMO）公司。公司通过开放式、一体化生物制药能力和技术赋能平台，提供全方位的端到端服务，帮助合作伙伴发现、开发及生产生物药，实现从概念到商业化生产的全过程，加速全球生物药研发进程，降低研发成本，造福病患。 药明生物在中国、美国、爱尔兰、德国和新加坡拥有超过12000名员工。通过药明生物的专业服务团队，以及先进技术和精深洞见，公司为客户提供高效经济的生物药解决方案。截至2024年12月底，药明生物帮助客户研发和生产的综合项目高达817个，其中包括21个商业化生产项目（不包括新冠项目）。 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药明生物再次通过日本PMDA GMP检查 累计通过42次全球药品监管机构检查

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药明生物再次通过日本PMDA GMP检查累计通过42次全球药品监管机构检查