Fangsheng Pharmaceutical(SH:603998) Shen Zhen Shang Bao·2026-01-11 14:42Core 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line for Indobufen at the new facility in Hunan Wancheng Economic Development Zone was found non-compliant due to outdated standards used in the production of intermediate 1 [1] - The company received a GMP compliance inspection notice, indicating that the production address is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]