- C Ray Therapeutics (Chengdu) Co., Ltd. has obtained a Radiopharmaceutical Manufacturing License (Category C) following a successful regulatory inspection.
- The company said the license is the first Category C approval issued under the updated NMPA Announcement No. 134 of 2025 and supports its contract manufacturing operations for radiopharmaceuticals.
C Ray Therapeutics (Chengdu) Co., Ltd. has received a Radiopharmaceutical Manufacturing License (Category C) after successfully completing an on-site inspection conducted by an expert panel organized by the Sichuan Provincial Drug Review Center and the relevant regulatory authority. According to the company, the approval marks the first Category C license issued in the radiopharmaceutical sector following the introduction of NMPA Announcement No. 134 of 2025.
The company said the updated regulations introduced more stringent requirements for quality management, accountability, and on-site inspections for pharmaceutical contract manufacturing. C Ray Therapeutics stated that the approval recognizes its compliance framework, operational execution capabilities, and ability to ensure reliable and consistent product supply, while supporting future regulatory submissions and commercialization activities for partner programs.
According to the company, radiopharmaceutical manufacturing requires short production timelines, strict quality controls, and closely coordinated supply operations. C Ray Therapeutics said its manufacturing facility has been designed and managed in accordance with global cGMP standards to support these requirements.
To date, the company said it has delivered more than 100 CRDMO projects, providing end-to-end services across the product lifecycle, from early-stage research and development through commercial supply. The new license further supports its contract manufacturing capabilities for radiopharmaceutical products.
