TAIPEI (Taiwan News) — Taiwan's leading ODM probiotic raw material manufacturer, Glac Biotech, has been awarded the "Generally Recognized As Safe" (GRAS, GRN001130) certification by the US Food and Drug Administration for its independently developed probiotic, Lactobacillus rhamnosus MP108.

This milestone is not only a breakthrough for Glac Biotech in international regulatory certification but also the first case of Taiwanese probiotic raw material being granted GRAS certification by the US FDA. It marks a key leap forward for Taiwan's biotech industry.

To share this historic achievement, Glac Biotech Deputy Project Manager Hsia Ko-chiang (夏可強) attended the 2025 Annual Microbiome Research and Application in Health kick-off meeting led by the National Science and Technology Council and hosted by the Taiwan Microbiota Consortium on June 5.

During the meeting, Hsia delivered a speech about "How MP108 Became Taiwan's First Successful GRAS Application" and detailed the work of how a top team of industry experts and professors from across Taiwan contributed to the GRAS certification. He said the process underwent rigorous scientific verification and passed complicated regulatory procedures.

GRAS certification is the golden key allowing many agreements to enter the US market for food and dietary supplements. The certification indicates that the ingredient is safe under general use conditions. In addition, MP108 has also passed the "List of Bacteria that Can Be Used in Infant Food" by China's National Health Commission, clearing the way for widespread use in infant formula.

"The fact that MP108 has won this honor is the result of the efforts and resources invested by Glac Biotech's R&D team over the years. It is also recognition of our independent innovation capabilities and international layout," said Hsia. He went on to explain the many challenges and complexities of GRAS applications.

"We are very honored to share this first for Taiwan and discuss our experience with the domestic academic and research community. We hope that it will inspire more Taiwanese biotech companies to seek international certification and jointly enhance the global competitiveness of Taiwan's biotech industry."

The invitation by the NSTC to share the company's experience as a leader in the field of probiotics with products such as PROMEX® probiotic manufacturing technology and one-stop solutions, PRIMETEK®, providing industry chain vertical integration services from front-end strain screening, efficacy verification, production and manufacturing, to back-end regulatory application, to enable customers to create high-end products that meet international standards successfully.

In the future, Glac Biotech will continue to deepen its research and development of probiotics, constantly pursuing the highest international quality standards. It will also work hand in hand with Taiwan's industry, government, academia, and research circles to jointly promote the country's probiotics and microbial research results to the world and contribute to the global health industry.