山河药辅（300452）披露通过美国FDA现场检查公告，2月4日股价上涨2.8%

Core Viewpoint - The company, Anhui Shanhe Pharmaceutical Excipients Co., Ltd., successfully passed its first on-site inspection by the U.S. FDA, indicating that its quality management system meets international standards, which is expected to facilitate the expansion into U.S. and other international markets [1]. Group 1: Stock Performance - As of February 4, 2026, the stock price of Shanhe Pharmaceutical Excipients closed at 15.77 yuan, reflecting a 2.8% increase from the previous trading day [1]. - The stock opened at 15.35 yuan, reached a high of 16.01 yuan, and a low of 15.28 yuan, with a trading volume of 2.75 billion yuan and a turnover rate of 8.84% [1]. Group 2: FDA Inspection - The company underwent an on-site inspection by the U.S. FDA from December 4 to December 5, 2025, covering six major systems: quality management, production management, facility and equipment management, laboratory quality control, material and packaging label management [1]. - The company received the FDA's Establishment Inspection Report (EIR), confirming that the inspection was completed successfully [1]. Group 3: Market Implications - The successful FDA inspection is expected to positively impact the company's domestic pharmaceutical excipients business by reducing reliance on imports [1]. - The company cautions investors about potential risks to overseas business due to market conditions, tariffs, and exchange rates [1].