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

Glac Biotech Achieves GRAS Approval for Probiotic Strain CP-9

On September 15, 2025, Glac Biotech, a leading Taiwanese probiotics and postbiotics developer, announced that its primary probiotic strain CP-9 (Bifidobacterium lactis CCTCC M 2014588) has been granted Generally Recognized As Safe (GRAS) status by the Food and Drug Administration (FDA) of the United States. This milestone signifies the uniqueness of the company as it becomes the sole manufacturer of probiotic raw materials in Taiwan holding multiple GRAS approvals from the FDA. Previously, its strain Lactobacillus rhamnosus MP108 received the same recognition in 2023.

The approval of CP-9 underscores its safety and quality, allowing its use in various food and beverage products at levels of up to 10⁹ colony-forming units (CFU) per serving. The approved applications are extensive and include:

• - Sports and energy drinks
• - Fortified waters
• - Bottled teas
• - Cereals
• - Dairy and non-dairy products
• - Nutritional bars
• - Candy
• - Fruit juices
• - Soy and plant-based proteins
• - Infant foods

Notably, the newly approved CP-9 strain was a finalist at the 2023 NutraIngredients Awards, having been studied for its role in gut health and immune regulation. With the FDA's GRAS status, this strain augments Glac Biotech’s portfolio, aiming to cater to both infant and family nutrition markets alongside established strains like Bifidobacterium lactis BB-12.

Expanding Probiotic and Postbiotic Solutions

Glac Biotech’s journey with GRAS-certified products began with its first strain, MP108, recognized for the NutraIngredients Awards in 2021 and later approved by the FDA in 2023. MP108 holds the distinction of being the first probiotic strain in Asia approved for infant use, with clinical and safety data supporting its application at the same CFU levels as CP-9 across a variety of products:

• - Sports and energy drinks
• - Fortified waters
• - Nutritional beverages
• - Bottled teas
• - Processed fruits and juices
• - Cereals
• - Cheeses
• - Yogurts
• - Milk-based desserts
• - Soy products
• - Nutritional bars
• - Candies
• - Infant foods

In the postbiotic domain, Glac Biotech’s flagship product, Totipro®, is already available in Europe, Southeast Asia, and North America and is expected to submit a GRAS application shortly. Totipro® is distinctive as it is the only publicly declared raw material meeting all four postbiotic categories defined by the International Probiotics Association (IPA): intact cells (IC), cell fragments and cytoplasmic content (FC), microbial metabolites (MM), and fermentation media containing microbial components (CX).

According to Shin-Yu Tsai, Head of Product and Marketing at Glac Biotech, “The FDA’s GRAS approval represents a significant standard of quality and safety. With CP-9 now approved, MP108 already recognized, and the upcoming submission for Totipro®, Glac Biotech consistently advances its probiotics and postbiotics research in alignment with international standards. Our efforts will continue to be grounded in scientific evidence, collaborating with global partners to develop reliable health solutions.”

For more information, visit glacbiotech.com or follow Glac Biotech on LinkedIn and Facebook.

About Glac Biotech

Founded in 2008, Glac Biotech is a subsidiary of Center Laboratories Inc., the largest liquid pharmaceutical manufacturer in Taiwan. The company is exclusively focused on probiotics (PRONULIFE®) and postbiotics (Totipro®), with over 30 researchers and 30 quality specialists overseeing strain development, patents, clinical validation, and international certification.