近日，广州白云山医药集团股份有限公司发布公告称，其下属分公司——广州白云山制药总厂收到国家药品监督管理局核准签发的《药品补充申请批准通知书》。该批件涉及公司核心产品之一的注射用头孢呋辛钠，批准内容主要包括变更药品生产工艺及质量标准等事项。此次获批意味着白云山制药在提升产品质量、优化生产工艺方面取得重要进展。通过引入更先进的生产技术与质控体系，不仅有助于增强产品的稳定性和安全性，也进一步巩固了该药品在抗生素领域的市场竞争力。注射用头孢呋辛钠作为广谱抗生素，广泛用于治疗呼吸道、泌尿系统及皮肤软组织等多种细菌感染，在临床中具有重要地位。白云山方面表示，本次补充申请获批将为后续产品一致性评价、集采投标及国际市场拓展奠定坚实基础。公司将继续秉持“质量为先”的理念，推动更多优质药品的研发与生产，为公众健康提供有力保障。
Recently, Guangzhou Baiyunshan Pharmaceutical Holdings Co., Ltd. announced that its subsidiary, Guangzhou Baiyunshan Pharmaceutical General Factory, has received a ‘Supplemental Drug Application Approval Notice’ issued by China’s National Medical Products Administration (NMPA). The approval pertains to one of the company’s key products—Cefuroxime Sodium for Injection—and includes changes to the drug’s manufacturing process and quality standards.This approval marks a significant step forward in Baiyunshan’s efforts to enhance product quality and optimize production processes. By implementing more advanced manufacturing technologies and quality control systems, the company aims to improve the stability and safety of the product, thereby strengthening its competitiveness in the antibiotic market. Cefuroxime Sodium for Injection is a broad-spectrum antibiotic widely used to treat bacterial infections of the respiratory tract, urinary system, and skin/soft tissues, playing a vital role in clinical practice.Baiyunshan stated that this supplemental approval will lay a solid foundation for future activities such as generic drug consistency evaluation, participation in centralized drug procurement tenders, and international market expansion. The company remains committed to its ‘quality-first’ philosophy and will continue advancing the development and production of high-quality medicines to better support public health.
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