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].

Core Viewpoint - The company, Yuandong Biotech (688513.SH), announced that its wholly-owned subsidiary, Chengdu Shode Pharmaceutical Co., Ltd., successfully passed FDA inspections for its naloxone nasal spray, receiving zero deficiencies in the reports [1] Group 1 - The FDA conducted current Good Manufacturing Practice (cGMP) inspections and Bioresearch Monitoring (BIMO) inspections from May 6 to May 9 and May 16 to May 22, 2025 [1] - The inspections were part of the approval process for the naloxone nasal spray [1] - Chengdu Shode Pharmaceutical received two Establishment Inspection Reports (EIR) from the FDA, indicating compliance with regulatory standards [1]

Core Viewpoint - The company, Yuandong Biotech (688513.SH), announced that its wholly-owned subsidiary, Chengdu Shode Pharmaceutical Co., Ltd., successfully passed FDA inspections for the production of Naloxone nasal spray with zero deficiencies [1] Group 1 - The inspections conducted by the FDA included Current Good Manufacturing Practice (cGMP) and Bioresearch Monitoring (BIMO) [1] - The inspections took place from May 6 to May 9 and May 16 to May 22, 2025 [1] - The company received two Establishment Inspection Reports (EIR) from the FDA confirming the successful inspections [1]

Core Viewpoint - Yuan Dong Biotech (688513.SH) announced that its subsidiary, Shuo De Pharmaceutical, received two on-site inspection reports from the US FDA, passing with zero deficiencies, which indicates compliance with FDA standards and supports the acceleration of its ANDA product approval process in the US [1] Group 1 - Shuo De Pharmaceutical successfully passed its second FDA on-site inspection, marking the first inspection of its nasal spray production line [1] - The inspected product is Naloxone Hydrochloride Nasal Spray, with FDA FEI number 3018360274 [1] - The successful inspection reflects the company's adherence to production management quality systems and regulatory compliance, facilitating the implementation of its internationalization strategy [1]

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]