Core Viewpoint - Chengdu Yuandong Pharmaceutical Co., Ltd. announced that its wholly-owned subsidiary, Chengdu ShuoDe Pharmaceutical Co., Ltd., successfully passed the FDA's pre-approval inspections for its Naloxone nasal spray product with zero deficiencies [1][2]. Group 1: Inspection Details - The FDA inspections took place from May 6 to 9 and May 16 to 22, 2025, focusing on current Good Manufacturing Practices (cGMP) and BioResearch Monitoring (BIMO) [1]. - The inspections were conducted for the Naloxone nasal spray product, specifically on the nasal spray production line [1]. - The inspection concluded with a zero deficiency report (no 483), indicating compliance with FDA standards [1]. Group 2: Product and Company Impact - This inspection marks the second time ShuoDe Pharmaceutical has undergone an FDA inspection and the first for its nasal spray production line [1]. - The successful inspection is expected to expedite the approval process for the company's submitted Abbreviated New Drug Applications (ANDA) in the U.S. and support the implementation of its internationalization strategy [1].
成都苑东生物制药股份有限公司 关于自愿披露全资子公司硕德药业通过美国FDA现场检查的公告