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“零缺陷”通过美国FDA审计,华熙生物全球信赖持续升级
Huan Qiu Wang· 2025-07-10 04:39
Core Viewpoint - Huaxi Biological Technology Co., Ltd. has received a "zero defect" result from the FDA, indicating the highest level of compliance in its quality management system, which will enhance its global market competitiveness and facilitate overseas business expansion [1][2]. Group 1: FDA Audit and Certification - The FDA audit lasted five days and was conducted according to ICH Q7 guidelines, covering six major systems including quality systems and laboratory systems, confirming the company's meticulous management and commitment to quality [2]. - This is not the first time Huaxi Biological has received a "zero defect" recognition; it previously passed a similar audit by the Korean MFDS in February 2025 [2]. - The company has successfully passed five FDA audits, one PMDA audit in Japan, and two MFDS audits in Korea for its sodium hyaluronate raw materials [2]. Group 2: Global Market Position - Huaxi Biological has established a significant presence in the global market, holding 34 registration qualifications across various countries, including the EU, the US, Japan, and Korea, making it one of the suppliers with the most comprehensive registrations for pharmaceutical-grade sodium hyaluronate [2][4]. - The company has a marketing and supply chain network spanning over 70 countries and regions, with overseas subsidiaries in key markets such as the US, France, Japan, and South Korea [4]. Group 3: Product Development and Recognition - In addition to raw materials, Huaxi Biological has received global recognition in skin science innovation and medical devices, recently obtaining a medical device registration certificate from Brazil's ANVISA, known for its stringent regulatory standards [4]. - The company has accumulated over 70 medical device and skincare product registrations across more than 15 countries or regions [4]. Group 4: Long-term Strategy and Investment - Huaxi Biological emphasizes long-term research and development investment, maintaining high standards and a stable supply chain to build a strong foundation for quality products and brand development [5]. - The company follows a "technology breakthrough—quality control—global compliance—standard leadership" model, focusing on international standards and resource allocation to enhance its industrial capabilities and product standards [5].
【财闻联播】7天6板牛股,紧急提示风险!部分航线登机只需提前15分钟了
券商中国· 2025-07-09 11:09
★ 宏观动态 ★ "中国军方用激光瞄准德国飞机"?外交部回应 毛宁表示,经向有关部门了解,德方所称的信息与中方了解的事实完全不符。中国海军在亚丁湾索马里海域实 施护航行动,履行大国责任,为维护国际航道安全作出贡献,也同德方和欧方保持着良好的沟通,双方应当本 着实事求是的态度,及时加强沟通,避免误解误判。 国家统计局:2025年6月份工业生产者出厂价格同比下降3.6% 国家统计局公布数据,2025年6月份,全国工业生产者出厂价格同比下降3.6%,环比下降0.4%;工业生产者购 进价格同比下降4.3%,环比下降0.7%。上半年,工业生产者出厂价格比上年同期下降2.8%,工业生产者购进 价格下降2.9%。 国家发改委:402种药品新增进入国家医保药品目录 7月9日,外交部发言人毛宁主持例行记者会。 法新社记者提问,德国政府昨天表示,中国军方在红海用激光瞄准了一架德国飞机,称这一行为危及德方人员 安全,完全不可接受,德国已召见中国大使进行交涉,中方对此有何评论? 据新华社报道,国家发展改革委副主任周海兵7月9日在国新办举行的"高质量完成'十四五'规划"首场新闻发布 会上表示,"十四五"以来,402种药品新增进入国家医 ...