Recently, Jiudian Hongyang successfully completed the on-site cGMP inspection by the Brazilian National Health Surveillance Agency (ANVISA) for its secnidazole product line. The company's standardized, end-to-end production quality management system received high praise from the ANVISA inspectors. This marks the third time since its establishment that Jiudian Hongyang has undergone an on-site inspection by an international authoritative pharmaceutical regulatory agency. Brazil is the seventh-largest pharmaceutical market in the world. This certification not only represents a key opportunity for the company's products to enter the global market but also serves as an important test of its production quality management system against international standards, holding far-reaching significance for the company's international development.

Early in 2026, Jiudian Hongyang formally received notification from ANVISA regarding the inspection, which was scheduled to take place over five days between April and May to thoroughly verify the compliance of the entire production quality management process for secnidazole with Brazilian regulatory requirements. To ensure the smooth progress of the certification, the company's Quality Department took the lead in coordinating various departments during the preparation phase, conducting comprehensive and rigorous self-inspections and corrective actions across the entire production quality management process. The team focused on two main areas: software control of documentation and records, and hardware operation and maintenance of plant facilities and equipment. Targeted self-inspection plans and improvement strategies were developed, corrective measures were implemented item by item, and the compliance foundation was comprehensively strengthened.

From April 27 to May 1, two senior inspectors appointed by ANVISA were stationed at Jiudian Hongyang to conduct the five-day on-site certification audit. During the audit, the inspectors used secnidazole as the focal point and conducted a comprehensive review of the company's production quality management, covering core modules including quality assurance and quality control management, production management, materials management, plant facilities and equipment management, and validation and change control management. The inspectors rigorously and meticulously examined the on-site management practices and documentation records across various departments, accurately assessed the compliance of the company's production quality management system with Brazilian GMP requirements, and gave full recognition to the company's standardized construction and implementation of cGMP.

The successful completion of the ANVISA on-site inspection solidifies the compliance foundation for Jiudian Hongyang's secnidazole products to penetrate the Brazilian market and radiate to the broader global market, significantly enhancing the company's core competitiveness in the Latin American and global pharmaceutical markets. Jiudian Hongyang will continue to improve its existing product quality management system, optimize and upgrade its production quality management framework, deepen its international compliance capabilities, and continuously enhance its brand influence in the international pharmaceutical market.