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.

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.”