Recently, the National Medical Products Administration (NMPA) announced that the indobufen active pharmaceutical ingredient (API) produced by Hunan Fangsheng Pharmaceutical Co., Ltd. failed to meet the requirements of Good Manufacturing Practice (GMP) during an inspection. The identified deficiencies primarily involved inadequate process controls, quality management systems, and documentation in the API manufacturing process, potentially leading to inconsistent product quality or safety risks. Indobufen is an antiplatelet agent commonly used for the prevention and treatment of cardiovascular and cerebrovascular diseases associated with atherosclerosis. As the foundational component of finished drug products, the quality of APIs directly impacts the safety and efficacy of medications. In response, regulators have ordered the company to halt production and sales of the affected product and implement corrective actions within a specified timeframe. Fangsheng Pharmaceutical stated it will fully cooperate with the investigation, identify root causes, and enhance its internal quality control systems to ensure future compliance with national pharmaceutical standards. This incident underscores the critical importance for pharmaceutical manufacturers to strictly adhere to GMP guidelines and maintain rigorous quality management throughout the production lifecycle to safeguard public health.
近日，国家药品监督管理局发布通告称，湖南方盛制药股份有限公司生产的吲哚布芬原料药在监督检查中被发现不符合《药品生产质量管理规范》（GMP）要求。此次检查主要涉及原料药的生产过程控制、质量管理体系及文件记录等方面存在缺陷，可能导致产品质量不稳定或存在安全隐患。吲哚布芬是一种抗血小板聚集药物，常用于预防和治疗动脉粥样硬化相关的心脑血管疾病。原料药作为制剂的基础，其质量直接影响最终药品的安全性和有效性。目前，监管部门已责令企业暂停相关产品的生产和销售，并限期整改。方盛制药表示将积极配合调查，全面排查问题根源，加强内部质量管控体系，确保后续产品符合国家药品标准。此事件再次提醒制药企业必须严格遵守GMP规范，强化全过程质量管理，以保障公众用药安全。
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