维亚生物全资子公司朗华制药顺利通过美国FDA现场检查-动脉网

Viva Biotech's Wholly-Owned Subsidiary Langhua Pharmaceutical Successfully Passes U.S. FDA On-Site Inspection

CISION 等信源发布 2025-03-28 15:46



可切换为仅中文







SHANGHAI

上海

，

March 28, 2025

2025年3月28日

/PRNewswire/ -- Zhejiang Langhua Pharmaceutical Co., Ltd. ('Langhua Pharmaceutical'), a wholly-owned subsidiary of Viva Biotech Holdings ('Viva Biotech'), underwent a cGMP (Current Good Manufacturing Practices) on-site inspection by the U.S. Food and Drug Administration ('FDA'), and received the EIR (Establishment Inspection Report) from the FDA.

/PRNewswire/ -- 浙江朗华制药有限公司（“朗华制药”），维亚生物科技控股集团（“维亚生物”）的全资子公司，接受了美国食品药品监督管理局（“FDA”）的cGMP（现行良好生产规范）现场检查，并收到了FDA发出的EIR（设施检查报告）。

This is the fourth time that Langhua Pharmaceutical has undergone and passed the on-site inspection by the FDA, indicating the effective operation of the Company's quality control system. It also enables the Company to offer globally customized research, development, and production services to pharmaceutical enterprises worldwide..

这是朗华制药第四次接受FDA现场检查并顺利通过，表明公司质量管控体系运行有效，也使得公司能够为全球制药企业提供全球化定制研发生产服务。

In the second half of 2024, Langhua Pharmaceutical has undergone the on-site inspection by the FDA which covered six major systems, namely, quality system, materials, production, packaging and labeling system, equipment and facilities, and laboratory control.

2024年下半年，朗华制药接受了FDA覆盖六大体系的现场检查，即质量体系、物料、生产、包装标签体系、设备设施和实验室控制。

After more than a decade of dedicated growth, Langhua Pharmaceutical has become a one-stop CDMO solution for small molecule drug. The company offers comprehensive solutions spanning from Active Pharmaceutical Ingredients (APIs) to Finished Dosage Form (FDF), from pre-clinical to commercial supply, covering the entire lifecycle with efficient, flexible, and high-quality CDMO services.

经过十多年的专注发展，朗华制药已经成为小分子药物的一站式CDMO解决方案。公司提供从活性药物成分（API）到最终剂型（FDF）、从临床前到商业供应的全面解决方案，涵盖整个生命周期，提供高效、灵活和高质量的CDMO服务。

Langhua's innovative R&D network spans three strategic centers situated in .

朗华的创新研发网络横跨三个战略中心，分别位于。

Shanghai

上海

，

Ningbo

宁波

, and Taizhou, collectively offering over 13,000 square meters of laboratory space and a team of over 700 researchers. The company has established comprehensive quality management systems, EHS (Environment, Health, and Safety) protocols, and intellectual property protection mechanisms. To date, Langhua Pharmaceutical has passed audits and certifications from leading authorities including .

，台州合计提供超过13,000平方米的实验室空间和700多人的研究团队。公司建立了全面的质量管理系统、环境健康安全（EHS）协议和知识产权保护机制。迄今为止，朗华制药已通过包括领先的权威机构在内的审计和认证。

China's

中国的

National Medical Products Administration (NMPA), the FDA, the European Directorate for the Quality of Medicines (EDQM), Pharmaceutical and Medical Devices Agency (PMDA), Brazilian Health Regulatory Agency (ANVISA), and the World Health Organization (WHO). Additionally, it has also passed the PSCI audit.

国家药品监督管理局（NMPA）、美国食品药品监督管理局（FDA）、欧洲药品质量管理局（EDQM）、日本药品和医疗器械管理局（PMDA）、巴西卫生监管局（ANVISA）以及世界卫生组织（WHO）。此外，它还通过了PSCI审核。

Langhua Pharmaceutical has contributed to more than 20 new drugs launches in the past years, with a product line that spans oncology, HIV, diabetes, and cardiovascular fields, showcasing a strong track record of successful deliveries..

近年来，朗华制药已助力超过20款新药成功上市，产品线横跨肿瘤、艾滋病、糖尿病和心血管领域，成功交付能力有目共睹。

Dr.

博士

Cheney Mao

毛晨熠

, Chairman and CEO of Viva Biotech Holdings, stated: 'We are glad to see Langhua Pharmaceutical passing the FDA cGMP on-site inspection again, demonstrating that our quality management system and production environment facilities consistently meet international standards, providing a solid foundation for our further expansion into the international market.

维亚生物控股集团董事长兼CEO表示：“我们很高兴看到朗华制药再次通过FDA的cGMP现场检查，这充分证明我们的质量管理体系和生产环境设施持续符合国际标准，为公司进一步开拓国际市场提供了坚实的基础。

In the future, we will continue to promote the construction of CDMO production capacity and deepen the synergy between CRO and CDMO businesses to empower the development and production of new drugs for more global partners.'.

未来，我们将持续推进CDMO产能建设，深化CRO与CDMO业务的协同，为更多全球合作伙伴赋能新药研发与生产。

Mr.

先生

Weidong Zhang

张伟东

, Senior Vice President of Viva Biotech, Executive Vice President and Manufactory General Manager of Langhua Pharmaceutical, expressed: 'We are delighted that Langhua Pharmaceutical has once again gained FDA recognition. We always uphold the principle that GMP compliance is the 'bottom line' that Langhua must adhere to, implementing comprehensive quality control at every stage from raw materials to finished products.

维亚生物高级副总裁、朗华制药执行副总裁及工厂总经理表示：“朗华制药再次获得FDA认可，我们感到非常高兴。我们始终秉持GMP合规是朗华必须坚守的‘底线’原则，在从原料到成品的每个阶段都实施全面的质量控制。

In the future, Langhua Pharmaceutical will sustain to adhere to a meticulous quality management philosophy, continuously enhancing its innovative R&D capabilities to provide higher-quality and more reliable CDMO services to global clients.'.

未来，朗华制药将持续坚持精益求精的质量管理理念，不断提升创新研发能力，为全球客户提供更高质量、更可靠的CDMO服务。

About Viva Biotech

关于维亚生物

Established in 2008, Viva Biotech (01873.HK) provides one-stop services ranging from early-stage Structure-Based Drug R&D to commercial manufacturing to global biopharmaceutical innovators. We offer leading early-stage to late-phase drug discovery expertise by integrating our dedicated team of experts, cutting-edge technology platforms, and state-of-the-art equipment in X-ray crystallization, Cryo-EM, DEL, ASMS, SPR, HDX, AIDD/CADD, and much more.

成立于2008年的维亚生物（股票代码：01873.HK）为全球生物制药创新者提供从早期基于结构的药物研发到商业化生产的一站式服务。我们通过整合专业的专家团队、前沿的技术平台以及在X射线结晶学、冷冻电镜、DNA编码化合物库、亲和质谱筛选、表面等离子体共振、氢氘交换、人工智能/计算机辅助药物设计等领域的先进设备，提供从早期到后期药物发现的领先专业知识。

Our business covers all aspects of therapeutic strategies and drug modalities, including small molecules and biologics across the pharma and biotech spectrum. The experienced chemistry team, led by senior medicinal chemists and drug discovery biologists, provides services for drug design, medicinal chemistry (hit to lead and lead optimization), custom synthesis, chemical analysis and purification, kilogram scale-up, peptide synthesis and corresponding bioassays.

我们的业务涵盖治疗策略和药物模式的各个方面，包括小分子和生物制品在内的整个制药和生物技术领域。由资深药物化学家和药物发现生物学家领导的经验丰富的化学团队，提供药物设计、药物化学（从苗头化合物到先导化合物及先导化合物优化）、定制合成、化学分析与纯化、千克级放大、肽合成及相应的生物测定等服务。

With our subsidiary, Langhua Pharma, we offer our worldwide pharmaceutical and biotech partners a one-stop integrated CMC (Chemical, Manufacturing, and Control) service from preclinical to commercial manufacturing. Additionally, Viva embedded an equity for service (EFS) model to high potential startups to address unmet medical needs..

通过我们的子公司朗华制药，我们为全球制药和生物技术合作伙伴提供从临床前到商业化生产的一站式综合CMC（化学、制造和控制）服务。此外，Viva还为高潜力初创公司嵌入了股权换服务（EFS）模式，以满足未被满足的医疗需求。

About Langhua

关于浪花

Zhejiang Langhua Pharmaceutical Co., Ltd, is a comprehensive pharmaceutical company engaged in research and development, production, marketing, and sourcing of pharmaceutical products. As the subsidiary of Viva Biotech Holdings, the leading enterprise in the field of innovative drug discovery, we offer our worldwide partners a One-Stop CDMO solution in new drugs' entire life cycle for small molecule Active Pharmaceutical Ingredients (APIs) and Finished Dosage Form (FDF), from pre-clinical to commercial supply..

浙江朗华制药有限公司是一家集研发、生产、营销和采购为一体的综合性制药公司。作为创新药物研发领域领先企业维亚生物控股集团的子公司，我们为全球合作伙伴提供从小分子原料药（API）到成品剂型（FDF）的新药全生命周期一站式CDMO解决方案，从临床前到商业化供应。

SOURCE Viva Biotech

来源：维亚生物

WANT YOUR COMPANY'S NEWS

想要你公司的新闻吗

FEATURED ON PRNEWSWIRE.COM?

荣登PRNEWSWIRE.COM？

440k+

44万+

Newsrooms &

新闻编辑室 &

Influencers