This certification validates the company’s compliance systems and execution capabilities within the complex landscape of radiopharmaceutical production. By aligning with updated regulatory requirements for quality management and responsibility allocation, the facility is now better positioned to support its growing portfolio of contract development and manufacturing projects. The company operates a 28,000-square-meter site under a Class A Radiation Safety License, providing infrastructure for over 30 different radioisotopes.
C-Ray Therapeutics Secures Radiopharmaceutical License in Chengdu
On June 23, 2026, C-Ray Therapeutics cleared rigorous on-site inspections in Chengdu to secure its Radiopharmaceutical Production License. The authorization, granted by Sichuan provincial and national defense regulators, marks a significant milestone for the firm as it pivots to meet stringent new standards for outsourced pharmaceutical manufacturing in China.
Since its inception, the firm has managed more than 100 projects, ranging from early-stage research to late-phase clinical supply. With two programs currently in Phase III trials and nearly 30 advanced into investigator-initiated trials, this regulatory approval provides the necessary foundation to accelerate commercial-scale production. The facility’s ability to navigate these high-stakes manufacturing demands reinforces its role as a key player in the regional radiopharmaceutical supply chain.
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