Primo Biotechnology's Significant Achievement in GMP Certification
Primo Biotechnology Co., Ltd. (NASDAQ: PRMO) is thrilled to announce its Taoyuan pharmaceutical facility has received dual certification for PIC/S GMP and GDP from the Taiwan Food and Drug Administration (TFDA). This key achievement illustrates the company's unwavering commitment to international quality standards in nuclear medicine production, setting the stage for an impressive global market expansion.
Strengthening Global Market Reach
Since commencing construction in 2023, the focus at Primo has been to create an efficient, internationally compliant manufacturing facility. The company integrated an advanced, automated production system that leverages over 30 years of expertise in radiopharmaceuticals. Remarkably, it achieved this significant milestone in less than two years, which enhances local supply capacities and accelerates the clinical trial phase for new drug candidates. This accomplishment builds international confidence and facilitates potential partnerships in the global medical landscape.
Introducing Essential Radiopharmaceuticals
In addition to the certification, Primo secured TFDA approval for Fluorodeoxyglucose F-18 (18F-FDG) in April 2025. This critical radiopharmaceutical is essential for PET/CT imaging, facilitating the diagnosis of cancer as well as various neurological and cardiac conditions. The anticipated commercial launch of 18F-FDG is expected to positively impact the company's operational performance, further supporting its aim to provide innovative medical solutions.
Expanding the Portfolio of Radiopharmaceuticals
Primo is actively growing a diverse portfolio of radio theranostics radiopharmaceuticals, showcasing its determination to navigate the high technical and regulatory challenges in the field. The company is venturing into Clinical Research Organization (CRO) and Contract Development and Manufacturing Organization (CDMO) services. By developing a seamless integration of drug development, pre-clinical trials, and manufacturing, Primo fosters close collaborations with partners, expediting new drug approvals in the industry.
Ensuring Safe and Efficient Operations
Besides achieving GMP and GDP certifications, Primo is licensed by Taiwan's Atomic Energy Council, ensuring safe transport of radioactive materials. By adhering to GDP standards, it guarantees secure and efficient delivery of radiopharmaceuticals to clients. The strategic location, a mere 30 minutes from Taoyuan International Airport, provides a logistical advantage that enhances global operations.
Looking to the Future with Confidence
The attainment of PIC/S GMP and GDP certifications marks a pivotal milestone for Primo. The company is committed to bolstering its manufacturing and research capabilities to compete effectively in the global nuclear medicine market. By collaborating with top-tier medical institutions worldwide, Primo aims to provide high-quality diagnostic and therapeutic radiopharmaceuticals, significantly enhancing patient care across the globe.
About Primo Biotechnology Co., Ltd.
Primo is at the forefront of biotech innovation, specializing in the research and production of radiopharmaceuticals. With its internationally certified facilities, the company is dedicated to advancing precision molecular imaging technologies to improve the lives of cancer patients. Headquartered in Taipei, Primo collaborates with both local and global partners to catalyze advances in precision cancer care. For more information, visit Primo's official website and stay updated on their latest initiatives through social media channels.
Frequently Asked Questions
What is PIC/S GMP certification?
PIC/S GMP certification is an acknowledgment of a pharmaceutical facility's compliance with international Good Manufacturing Practices, ensuring quality in production processes.
What impact will the certification have on Primo?
Obtaining this certification enhances Primo’s reputation, facilitates entry into global markets, and improves partnerships with healthcare providers.
What products does Primo focus on?
Primo focuses on developing radiopharmaceuticals used for diagnostic imaging and therapeutic applications, particularly in oncology.
How does Primo ensure safety in its operations?
Primo is licensed by Taiwan's Atomic Energy Council, following strict guidelines for the safe handling and transport of radioactive materials.
Where can I find more information about Primo?
Additional information can be found on Primo's official website and by following the company on their social media platforms.
