Primo Biotechnology Co, Ltd, a Taiwan-based radiopharmaceutical company, announced on Thursday that its Taoyuan pharmaceutical facility has successfully passed inspection by Taiwan Food and Drug Administration (TFDA) and has been award dual certification for PIC/S GMP and GDP.

This achievement is claimed to confirm that Primo meets international quality standards for nuclear medicine production and sets the stage for global market growth.

Primo also obtained TFDA market approval in April 2025 for Fluorodeoxyglucose F-18 (18F-FDG). This radiopharmaceutical for PET/CT imaging plays a key role in diagnosing cancers as well as neurological and cardiac conditions. The commercial launch of F-18 FDG is expected positively contribute to the company's operational performance.

By integrating drug development, pre-clinical trials and manufacturing into its radiopharmaceutical platform, Primo says that it enables close collaboration with partners and supports the acceleration of new drug approvals.

In addition to GMP and GDP certification, Primo is licensed by Taiwan's Atomic Energy Council for the safe transport of radioactive materials.