亨迪药业(301211.SZ):公司通过美国FDA现场检查

Core Viewpoint - Hendi Pharmaceutical (301211.SZ) successfully passed the FDA's CGMP inspection conducted from November 10 to 14, 2025, confirming compliance with U.S. regulations [1] Group 1 - The company underwent a routine inspection by the FDA, which is part of the current Good Manufacturing Practice (CGMP) regulations [1] - The FDA issued an Establishment Inspection Report (EIR) confirming the completion of the inspection [1] - The inspection was conducted in accordance with the U.S. Federal Regulations Title 21 (21 CFR) [1]

BIOCAUSE HEILEN PHARMA-亨迪药业(301211.SZ):公司通过美国FDA现场检查 - Reportify