C Ray Therapeutics, a contract research, development and manufacturing organization (CRDMO) specializing in radiopharmaceuticals headquartered in Chengdu, China, has received a Radiopharmaceutical Manufacturing License (Category C) following an on-site inspection conducted by an expert panel organized by the Sichuan Provincial Drug Review Center and China’s National Medical Products Administration (NMPA).

The company claims it is the first Category C license issued in the radiopharmaceutical sector following NMPA Announcement No. 134 of 2025, which introduced stricter requirements for quality management, accountability, and on-site inspections related to pharmaceutical contract manufacturing. The license recognizes the company’s compliance framework and operational execution capabilities for contract manufacturing, according to the announcement.

C Ray Therapeutics operates a 28,000-square-meter manufacturing and R&D facility designed in accordance with global cGMP standards, holding a Class A radiation safety license that supports commercial-scale operations across more than 30 radioisotopes, according to the company. The CRDMO said its facility includes a preclinical study center with both small and large lab animal capabilities, animal PET/CT imaging, and pathology labs for biodistribution and dosimetry analysis.

The company contends it has delivered more than 100 CRDMO projects to date, including 58 preclinical and molecular imaging CRO projects and 42 CDMO projects, with five programs reaching IND-enabling stages, 29 advancing to investigator-initiated trials, and seven entering clinical supply including two that have progressed to Phase III studies. C Ray Therapeutics said it has also supported development of 23 programs using Actinium-225, an isotope used in targeted alpha therapies that has faced global supply constraints.

The radiopharmaceutical industry is poised to reach an inflection point over next few years, according to William Blair analysts. Isotope producers and CDMOs are scaling up production capacity to meet the growing market demand.