HOME > News > Press Releases > 2025.08.07 Taiwan’s First GRAS-Certified Probiotic — Glac Biotech’s MP108 Achieves Historic U.S. FDA Recognition

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2025.08.07 Taiwan’s First GRAS-Certified Probiotic — Glac Biotech’s MP108 Achieves Historic U.S. FDA Recognition

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A new chapter in Taiwan’s biotech history has been written. Glac Biotech’s flagship probiotic strain, MP108, has officially received GRAS (Generally Recognized as Safe) certification from the U.S. FDA (GRN001130).
This landmark achievement marks the first time a probiotic developed in Taiwan has been granted GRAS status, instantly positioning Taiwan’s scientific innovation on the global stage.

GRAS: The Golden Ticket to the U.S. Market
Earning FDA GRAS certification is no small feat. It represents the culmination of rigorous safety reviews, toxicology assessments, and international-level quality standards. For Glac Biotech, MP108’s recognition is both a testament to product safety and production excellence and a gateway to the lucrative U.S. food and dietary supplement market.
But MP108’s impact doesn’t stop at the U.S. border. It has also been listed by China’s National Health Commission as an approved strain for infant nutrition, bridging the two largest markets in the world. This dual recognition underscores the strain’s strategic global potential.

Sharing the Journey: From Challenge to Triumph
On June 5, 2025, Glac Biotech Project Manager Kevin Hsia was invited to speak at the launch of the “Microbiome in Precision Health R&D and Applications” project. His presentation, “How MP108 Became Taiwan’s First GRAS-Certified Strain,” shared the challenges, learnings, and practical insights gained during the certification journey.
The message was clear: success came not by chance, but through years of investment in R&D, regulatory expertise, and international strategy.

One-Stop Solutions, Global Vision
Glac Biotech credits its achievement to its proprietary PRONEX® manufacturing technology and its PRIMETEK® integrated platform, which together provide customers with end-to-end solutions — from research and regulatory approval to finished product commercialization.
This milestone isn’t just about MP108. It’s about proving that “Taiwanese strains” can stand shoulder-to-shoulder with the world’s best. Glac Biotech is committed to continuing its mission of making Taiwan a recognized powerhouse in probiotics and postbiotics.
As the company proudly declares:
“Our vision is clear — to take Taiwan’s probiotics global, and to let the world experience the strength of Taiwanese science.”


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