Cell BioTech Co. Ltd., a leading innovator of food and dietary ingredients, guided by REJIMUS, INC., achieves No Objection from U.S. FDA for 11 Probiotics
GIMPO-SI, GYEONGGI-DO, REPUBLIC OF KOREA , March 14, 2024 /EINPresswire.com/ — Cell BioTech Co. Ltd., (KOSDAQ:CBT/049960), a leading innovator of novel food and dietary supplement microorganism ingredients, proudly achieved No Objection notices for 11 Probiotic strains from the U.S. Food & Drug Administration under the guidance of REJIMUS, INC., a preeminent regulatory management consultancy to the Food & Beverage and Dietary Supplement markets in the U.S.
“We are extremely pleased to have taken this significant step to drive long-term growth our business in the U.S. While there are numerous probiotic ingredient suppliers to the United States in and from around the world, the clear advantages in our patented probiotic technology platform and quality control practices, ensure ingredient scalability and reliability like no other, which is what leading consumer food brands can count on,” said Dr. Myung-jun Chung, CEO, Cell BioTech Co. Ltd. “We are currently the industry leader in our field throughout the greater Asia region, so naturally, taking the critical step to pursue GRAS Status with the FDA was essential to earning the trust and loyalty of new customers in the United States as we expand in the global marketplace.”
The Cell Biotech patented microorganism’s that have achieved No Objection from FDA are Streptococcus thermophilus CBT ST3, Lacticaseibacillus rhamnosus CBT LR5, Bifidobacterium bifidum CBT BF3, Lactobacillus acidophilus CBT LA1, Bifidobacterium breve CBT BR3, Bifidobacterium lactis CBT BL3, Bifidobacterium infantis CBT BT1, Bifidobacterium longum CBT BG7, Lacticaseibacillus casei CBT LC5, Lactiplantibacillus plantarum CBT LP3 and Lactococcus lactis subsp. lactis CBT SL6. All ingredients are permitted for use at levels up to 10^9 colony forming units (CFU)/serving in dairy products.
“We were tremendously grateful to have earned the first major ingredient program for the U.S. market for Cell BioTech Co. Ltd., and help them achieve a monumental success across several GRAS projects collectively,” said Brandon Griffin, CEO of REJIMUS, INC. “We’ve built a great team here comprised of experts in GRAS and NDI Notifications, and a robust process to better ensure successful notifications, as evidenced by our track record, especially for novel food ingredients produced from synthesis, biosynthesis or bio-fermentation processes which often have more complex manufacturing protocols. We’ve got the keys to achieving successful notifications for our clients and the strategic planning as well as partnering strategies to benchmark those successes faster, because at the end of the day, the most important factor for any ingredient program and notification thereof, is time to market.”
About Cell BioTech Co. Ltd.:
Cell BioTech Co. Ltd. is a leading global authority made up of more than 300 microbiological specialists who focus their research entirely on probiotic and related microorganisms. Based on a world-patented dual coating technology, the company has created a probiotic-specialized “One Stop Solution” to develop the best probiotic products with the aim of improving the intestinal health of people around the world. To learn more about Cell BioTech’s current innovations, ingredients and other resources to U.S. customers, please visit: https://www.cellbiotech.com
About REJIMUS, Inc.:
REJIMUS, INC. is a preeminent regulatory management consulting firm enabling companies in the Food, Dietary Supplement, Cosmetic and Homeopathic/OTC industries to develop novel ingredients and finished products with less legal and regulatory risks, while optimizing their quality operations and supply-chain under all applicable regulations. The company is a leader in helping bring new and novel ingredients and/or finished products to market fast. For more information on the markets served and service offerings, please visit: https://www.rejimus.com
Brandon M Griffin
REJIMUS, INC.
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