Core Viewpoint - Fangsheng Pharmaceutical (603998) announced that its new production line for the active pharmaceutical ingredient (API) Indobufen does not meet regulatory requirements following an inspection by the Hunan Provincial Drug Administration [1] Group 1: Inspection Results - The inspection conducted on November 2025 revealed that the production line for Indobufen at the new facility in Hunan Wancheng Economic Development Zone was found non-compliant due to outdated standards used in the production of intermediate 1 [1] - The company received a GMP compliance inspection notice, indicating that the production address is being changed from 789 Lushong Road, Changsha, Hunan, to 368 Huanglong Road, Wancheng Economic Development Zone [1] Group 2: Current Status and Future Plans - Indobufen API was approved for market launch in June 2024, and the company is currently in the pre-market preparation stage, with no sales yet [1] - The company has addressed the issues identified during the inspection and plans to reapply for inspection promptly [1] Group 3: Market and Regulatory Environment - The pharmaceutical products are characterized by high technology, high risk, and high added value, making future sales subject to market changes and regulatory factors, which introduces uncertainty [1] - On January 9, it was noted that the Hunan Securities Regulatory Bureau issued a warning letter to the accounting firm involved in the audit of Fangsheng Pharmaceutical's 2024 annual report due to multiple violations [2]

方盛制药（603998）(603998.SH)发布公告，近日，公司收到湖南省药品监督管理局签发的《药品GMP 符合性检查告知书》，2025年11月，药监局对公司位于湖南望城经济开发区铜官镇循环经济工业基地内 的生产地址进行了检查，检查范围为原料药(吲哚布芬);原料药车间(101车间)D区、F区与E区吲哚布芬生 产线。经检查，结论为不符合要求(主要系因在中间体1的生产中依据的标准未更新到最新版本导致)。 公司吲哚布芬原料药及制剂当前处于上市前准备阶段，尚未正式投放市场销售，本次检查不会对公司的 生产经营产生实质性影响。公司已针对检查中发现的问题进行了整改和完善，并将尽快重新申请检查。 医药产品因高科技、高风险、高附加值特点，其未来销售受市场变化、政策等诸多因素影响，存在不确 定性。请广大投资者谨慎决策，注意防范投资风险。 ...