Primo Biotechnology's Taoyuan Facility Receives Dual PIC/S GMP Certification for Global Nuclear Medicine Expansion

Primo Biotechnology's Milestone Achievement in Nuclear Medicine



Primo Biotechnology Co., Ltd. has exciting news to share with the global pharmaceutical community. The company's pharmaceutical facility in Taoyuan has officially passed rigorous inspections from the Taiwan Food and Drug Administration (TFDA), earning dual certifications for PIC/S GMP and GDP. This remarkable achievement underscores Primo’s unwavering commitment to meeting international standards, particularly in the production and distribution of radiopharmaceuticals relevant to nuclear medicine.

Since the groundbreaking construction began in 2023, Primo has been dedicated to creating a state-of-the-art facility designed to meet the high demands of the global market. The plant integrates advanced and automated production systems combined with over thirty years of experience in radiopharmaceutical manufacturing. This strategic development has allowed the company to secure its certification in a remarkably short timeframe of less than two years.

The timing of this certification aligns perfectly with the company’s goals to bolster domestic supply capabilities while simultaneously expediting clinical trials for new drug candidates. It enhances international client confidence and lays the foundation for expanded partnerships across global markets.

In addition to the certification, Primo has announced the approval of Fluorodeoxyglucose F-18 (18F-FDG) as of April 2025. This critical radiopharmaceutical is used extensively for PET/CT imaging, which plays pivotal roles in the diagnosis of various types of cancer as well as neurological and cardiac conditions. Its upcoming commercial launch is anticipated to significantly enhance Primo's operational performance and market presence.

Primo is not just stopping at F-18 FDG; the company is actively engaged in the development of a wide range of radio theranostic radiopharmaceuticals. Given the intricate technical and regulatory frameworks governing this field, Primo is also broadening its services to include Clinical Research Organization (CRO) and Contract Development and Manufacturing Organization (CDMO) services. This integrated approach to drug development—encompassing pre-clinical trials and manufacturing—allows for seamless collaboration with partners, accelerating the process of bringing new drugs to market.

Furthermore, the company is compliant with the stringent standards set forth by the GDP, which governs the safe and efficient transport of radiopharmaceuticals. This compliance is made possible through Primo's licensing from Taiwan's Atomic Energy Council, ensuring the secure handling and transport of radioactive materials. Their strategic location, a mere thirty minutes from Taoyuan International Airport, lends an additional logistical benefit, facilitating effortless global operations.

The achievement of obtaining PIC/S GMP and GDP certifications is a crucial stepping stone for Primo Biotechnology. The company is resolutely focused on enhancing its manufacturing capabilities and research capacities to solidify its competitive stance in the international nuclear medicine arena. By forging partnerships with leading medical institutions worldwide, Primo is committed to delivering top-tier diagnostic and therapeutic radiopharmaceuticals to healthcare providers and patients everywhere.

About Primo Biotechnology Co., Ltd.


Primo is at the forefront of biotechnology, specializing in the production and development of radiopharmaceuticals. With internationally accredited facilities, the company is devoted to advancing precision molecular imaging technologies to provide hope and future solutions for cancer patients. Headquartered in Taipei, Primo collaborates with both domestic and international partners to drive breakthroughs in precision cancer care. For more information about their services and developments, visit Primo’s website and follow the company on platforms such as Facebook and LinkedIn.

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