Primo's Taoyuan Facility Achieves PIC/S GMP Certification, Paving the Way for Global Expansion in Nuclear Medicine.

TAIPEI, April 24, 2025 /PRNewswire/ -- Primo Biotechnology Co., Ltd. ("Primo") proudly announces 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 demonstrates Primo's dedication to meeting international quality standards for nuclear medicine production and sets the stage for global market growth.

Since initiating construction in 2023, Primo has focused on establishing a high-efficiency, internationally compliant facility. By integrating advanced and automated production system with over 30 years of the team's radiopharmaceutical manufacturing experience in medical centers, the company achieved certification in less than two years. This milestone not only strengthens domestic supply capabilities but also accelerates clinical trial progress for new drug candidates and builds international client confidence—paving the way for expanded partnerships in the global markets.

Furthermore, Primo obtained TFDA market approval in April 2025 for Fluorodeoxyglucose F-18 (¹⁸F-FDG). This essential 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.

Beyond F-18 FDG, Primo is actively developing a broad portfolio of radio theranostics radiopharmaceuticals. Recognizing the high technical and regulatory barriers within this field, Primo is also expanding into CRO (Clinical Research Organization) and CDMO (Contract Development and Manufacturing Organization) services. By integrating drug development, pre-clinical trials and manufacturing into its radiopharmaceutical platform. Primo 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. By following GDP standards, Primo ensures secure and efficient delivery of radiopharmaceuticals. Its strategic location, just 30 minutes from Taoyuan International Airport, provides a logistical edge for global operations.

Securing PIC/S GMP and GDP certifications is a significant milestone for Primo. The company will continue to strengthen its manufacturing and research capabilities, enhancing its competitiveness in the global nuclear medicine market. By partnering with leading medical institutions worldwide, Primo is committed to delivering high-quality diagnostic and therapeutic radiopharmaceuticals to patients worldwide.

About Primo Biotechnology Co., Ltd.

Primo is a leading biotech company specializing in the development and manufacturing of radiopharmaceuticals. With internationally certified facilities, Primo is committed to using precision molecular imaging technology to bring hope and a future to cancer patients. Headquartered in Taipei, the company collaborates with domestic and international partners to drive advancements in precision cancer care. For more information, visit https://primobt.com and follow on Facebook and LinkedIn.

SOURCE Primo Biotechnology Co., Ltd.