On July 16, 2024, Porton Pharma Solutions Ltd. (hereinafter referred to as "Porton", "the company”, “We") announced that its Chongqing Changshou Site (CQ2) had undergone a cGMP (current Good Manufacturing Practice) on-site inspection by the U.S. Food and Drug Administration (hereinafter referred to as "FDA") from March 25 to 29, 2024. This cGMP inspection covered the Quality System, Production System, Materials System, and the Laboratory Controls System.

Recently, Porton received an EIR letter from the FDA, confirming that the site passed the cGMP inspection with no action indicated (NAI). Porton always adheres to the quality management policy of "One Porton, One Quality." This is the third time that the Porton Changshou Site (CQ2) has passed the U.S. FDA on-site inspection, following previous inspections in 2015 and 2018. This achievement affirms the effective operation of the company's quality management system and provides a strong guarantee for Porton's globalization process.

Established in 2006, Porton Changshou Site (CQ2) is an intelligent manufacturing factory. Aligned with customer requirements, the Changshou Site has successfully undergone inspections by regulatory agencies including NMPA, USFDA, PMDA, WHO, and EMA since its establishment. Currently, there are 11 workshops at the Porton Changshou Site, with reactor sizes ranging from 5L to 10,000L. This enables the delivery of DS products from kilograms to metric tons for global customers.

Up until now, Porton has built and put into operation more than 10 R&D and production sites covering China, the United States, and Europe in strict accordance with ICH guidelines. In the future, Porton will continue to uphold the principle of "One Porton, One Quality," embedding compliance work in the daily management of all R&D and production sites and throughout the entire life cycle of drug manufacturing. Porton remains committed to the customer-centric concept, providing high-quality and standard end-to-end CDMO services to global pharmaceutical and biotech companies, and firmly adheres to the mission of "Enabling the Public's Early Access to Good Medicines."