ESG Report 2025

66 8.3.2 Quality Supervision “Quality builds the enterprise; quality strengthens the enterprise” is the core production philosophy of The United Laboratories. Obtaining authoritative quality certification not only ensures that drugs safeguard customer health, but also enhances customer trust and confidence in our products. During the Reporting Period, the Group had nine production bases in operation, of which 44.4% had obtained GB/T 19001-2016 / ISO 9001:2015 quality management system certification, further consolidating our leading position in the industry. As one of the first comprehensive pharmaceutical enterprises in China to fully pass GMP certification, the Group has always strictly complied with relevant regulations and continuously met certification standards. During the Reporting Period, the Group successfully passed multiple quality certifications from authoritative domestic and international bodies. Throughout the year, the Group received a total of 34 inspections from external regulatory authorities at home and abroad, covering approximately 60 products, with no critical non-conformities found in any inspection, fully demonstrating our excellence in quality management. The external regulatory inspections received by the Group during the Reporting Period are shown in the figure below. International GMP Certification and Inspection The sterile API products of Zhuhai Company passed the on-site GMP inspection of the Brazilian National Health Surveillance Agency (ANVISA). Inner Mongolia Company's Amoxicillin API successfully passed the ANVISA on-site GMP inspection. Veterinary GMP Certification and Inspection Over 10 bulk medicine production lines of United Animal Healthcare passed the on-site veterinary GMP inspection. The powder for injection, tablets, disinfectants and several core production lines of Henan Lianmu passed the veterinary GMP inspection. Inner Mongolia Animal Healthcare obtained the new-version veterinary GMP certificate issued by the Inner Mongolia Autonomous Region Department of Agriculture and Animal Husbandry. Inner Mongolia Company passed the Ampicillin veterinary drug production licence and GMP inspection. International Standard Certification The sterile Ampicillin Sodium API manufactured by Zhuhai Company obtained the Certificate of Suitability to the European Pharmacopoeia (CEP) issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM). Testing Capability Accreditation The Quality Control Centre of Zhuhai Company passed the expansion assessment of its testing capabilities for the United States Pharmacopeia (USP) and the British Pharmacopoeia (BP) by the China National Accreditation Service for Conformity Assessment (CNAS). In March 2025, Inner Mongolia Company's Amoxicillin API successfully passed the ANVISA on-site GMP inspection. During the five-day inspection, the auditors conducted a comprehensive and rigorous review of the quality management system, workshop facilities, material control, production and validation processes, covering the API production workshop, quality control laboratory and warehousing facilities. The Company's sound quality management system and standardised production operations were highly praised by the auditors, who concluded that the Company's quality management level complied with Brazilian GMP standards. This certification has laid a solid foundation for expanding the Amoxicillin product into the South American market. Inner Mongolia Company's Amoxicillin API Passes Brazil ANVISA GMP Inspection The United Laboratories International Holdings Limited 2025 Environmental, Social and Governance Report