Glac Biotech Secures U.S. Food and Drug Administration GRAS Approval for Probiotic Strain CP-9

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Glac Biotech

15 Sep, 2025, 14:00 GMT

TAIPEI, Sept. 15, 2025 /PRNewswire/ -- Glac Biotech, a Taiwan-based developer of probiotics and postbiotics, announced that its core probiotic strain CP-9 (Bifidobacterium lactis CCTCC M 2014588) has been approved with Generally Recognized as Safe (GRAS) status by the U.S. Food and Drug Administration (FDA).

With this notification, Glac Biotech becomes the only probiotic raw material manufacturer in Taiwan to hold multiple FDA GRAS approval, following the recognition of Lactobacillus rhamnosus MP108 in 2023.

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Glac Biotech has now secured FDA GRAS approval for two probiotics for use in a broad array of food and beverage products.

Approval Highlights CP-9's Safety and Quality

According to the FDA filing, CP-9 is authorized for use at levels up to 10⁹ colony-forming units (CFUs) per-serving in a wide range of food and beverage products:

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

The newly approved CP-9 was a finalist at the 2023 NutraIngredients Awards and has been studied for its role in gut health and immune regulation. With FDA GRAS status, CP-9 expands Glac Biotech's portfolio and is expected to serve the infant and family nutrition markets alongside established strains such as Bifidobacterium lactis BB-12.

Growing Portfolio of Probiotic and Postbiotic Solutions

Glac Biotech's first GRAS-notified strain, MP108, was shortlisted for the NutraIngredients Awards in 2021 and approved by the FDA in 2023. It was the first probiotic strain in Asia to be approved for infant use. Supported by clinical and safety data, MP108 is permitted for use at up to 10⁹ CFUs per serving in:

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

Also advancing in postbiotics, Glac's flagship product Totipro® is available in Europe, Southeast Asia, and North America, and is planned for FDA GRAS submission in the near future. Totipro® is the only raw material publicly declared to meet all four postbiotic categories defined by the International Probiotics Association (IPA): intact cells (IC), cell fragments and cytoplasmic contents (FC), microbial metabolites (MM), and fermentation media containing microbial components (CX).

"FDA GRAS approval represents an important standard of quality and safety. With CP-9 now approved, MP108 already recognized, and Totipro® submission soon, Glac Biotech is advancing its probiotics and postbiotics research with consistency and international alignment. We will continue to base our work on scientific evidence, cooperating with partners worldwide to develop reliable health solutions," concluded Shin-Yu Tsai, Product and Marketing Department Manager of Glac Biotech.

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., Taiwan's largest liquid pharmaceutical manufacturer. The company focuses exclusively on probiotics (PRONULIFE®) and postbiotics (Totipro®), with over 30 researchers and 30 quality specialists overseeing strain development, patents, clinical validation, and international certification.

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