苑东生物：全资子公司硕德药业通过美国FDA现场检查

Core Viewpoint - The company has successfully passed the FDA's cGMP and BIMO inspections for its product, Naloxone nasal spray, which is expected to expedite the approval process for its ANDA products in the U.S. market and support its internationalization strategy [1] Group 1 - The company's wholly-owned subsidiary, Chengdu ShuoDe Pharmaceutical Co., Ltd., underwent FDA inspections from May 6 to 9 and May 16 to 22, 2025 [1] - The inspections resulted in a "zero defect" outcome (no 483), indicating compliance with FDA standards in production management quality systems and operational compliance [1] - The positive inspection results are anticipated to accelerate the approval timeline for the company's ANDA products in the U.S. [1]