Shanhe Pharmaceutical Auxiliary: The company successfully passed the FDA on-site inspection in the United States

Shanhe Pharmaceutical Auxiliary Announcement: The company underwent an on-site inspection by the U.S. Food and Drug Administration (FDA) from December 4, 2025, to December 5, 2025. The inspection covered six major systems: quality management, production management, facilities and equipment management, laboratory quality control, material management, and packaging label management. The company received the FDA-issued Establishment Inspection Report (EIR), confirming that the inspection has concluded and that the company successfully passed the FDA on-site inspection.

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