#Taiwan #Taipei #Glac Biotech #CP-9 #Bifidobacterium

Glac Biotech Secures FDA GRAS Approval for CP-9

Introduction
Taiwan's Glac Biotech, a prominent developer in the probiotic and postbiotic sector, has made waves in the health food industry by achieving GRAS (Generally Recognized As Safe) approval from the U.S. Food and Drug Administration (FDA) for their primary probiotic strain, CP-9 (Bifidobacterium lactis CCTCC M 2014588). This milestone marks a significant advancement for the company, setting it apart as the leading manufacturer of probiotic raw materials in Taiwan with multiple GRAS approvals from the FDA.

The Importance of GRAS Approval

The GRAS designation is a testament to the safety and efficacy of CP-9, allowing its use in a diverse array of food and beverage products. According to Glac Biotech, CP-9 can be safely included at levels of up to 10⁹ colony-forming units (CFUs) per serving in numerous categories:

• - Sports and energy drinks
• - Enriched waters
• - Bottled teas
• - Cereals
• - Dairy and non-dairy products
• - Nutritional bars
• - Candies
• - Fruit juices
• - Soy and plant-based protein products
• - Infant foods

This broad spectrum of applications positions CP-9 as a vital ingredient in enhancing nutrition and digestive health across various consumer markets. Notably, CP-9 was a finalist in the prestigious 2023 NutraIngredients Awards, showcasing its recognized potential within the health community.

Expanding Probiotic Portfolio

The recent approval of CP-9 expands Glac Biotech's product portfolio, which already includes the well-established strain MP108, also recognized with GRAS status. This strain was the first probiotic approved for use in children in Asia, receiving FDA approval in 2023 and playing a critical role in some of the same food categories as CP-9. With these pioneering products, Glac Biotech aims to target families seeking health-focused nutrition solutions.

Advancements in Postbiotics

In addition to its achievements in probiotics, Glac Biotech is also advancing its postbiotic product, Totipro®. This unique offering is available in Europe, Southeast Asia, and North America, with plans to gain GRAS certification from the FDA soon. Totipro® stands out as it fulfills all four categories of postbiotics defined by the International Probiotics Association (IPA), including intact cells and cellular fragments, microbial metabolites, and fermentation media.

Commitment to Science and Quality

The attainment of GRAS status for CP-9 underscores Glac Biotech's dedication to scientific research and international standards. Shin-Yu Tsai, manager of the Product and Marketing Department, emphasized the importance of these approvals in maintaining high quality and safety. “With the GRAS approval of CP-9, recognition of MP108, and the upcoming submission for Totipro®, Glac Biotech is consistently aligned with international research standards. We will continue our commitment to developing reliable health solutions backed by scientific evidence.”

Conclusion

Founded in 2008, Glac Biotech operates under the larger umbrella of Center Laboratories Inc., Taiwan's largest manufacturer of liquid pharmaceutical products. Leveraging a team of over 30 researchers and quality specialists, the company specializes exclusively in probiotics and postbiotics. As the health industry continues to evolve, Glac Biotech remains at the forefront, dedicated to understanding and improving human health through innovative probiotic solutions.
For more information about their offerings, visit glacbiotech.com or follow Glac Biotech on LinkedIn and Facebook.