Fangsheng Pharmaceutical(SH:603998) Cai Jing Wang·2026-01-12 04:06Core Viewpoint - Fangsheng Pharmaceutical (603998) has received a notice from the Hunan Provincial Drug Administration regarding non-compliance in a GMP inspection of its production site for the active pharmaceutical ingredient Indobufen, which is currently in the pre-market preparation stage [1] Group 1: Inspection Results - The inspection conducted in November 2025 concluded that the production site in the Wangcheng Economic Development Zone did not meet the required standards due to outdated production standards for intermediate 1 [1] - The inspection specifically focused on the production line for Indobufen and related processes [1] Group 2: Regulatory Approval and Market Readiness - Indobufen received approval for market launch in June 2024, but the product has not yet been officially released for sale [1] - The company is in the process of rectifying the issues identified during the inspection and plans to reapply for the inspection promptly [1]