Certificate and Awards

ANKASCIN® 568 defines industry standards with its global certifications, awards, and patents. Enhanced by GMP, ISO22000, and HACCP credentials, we uphold our promise of providing reliable, high-quality health solutions.

The World’s First and Only RYR Approved by the US FDA as an NDI

Since 1998, the US FDA has classified red yeast rice (RYR) products containing more than a trace amount of Monacolin K, which is structurally identical to the prescription drug lovastatin, as unapproved new drugs. Consequently, RYR containing Monacolin K cannot be sold legally as a dietary supplement in the US. Additionally, due to potential side effects of Monacolin K/statins, new EU regulations from 2022 have limited the content of Monacolin K to 3 mg per daily dosage in RYR products.

ANKASCIN® 568, featuring two active compounds, Monascin and Ankaflavin, and devoid of Monacolin K, has passed multiple safety assessments from patented strain to products. As a result, ANKASCIN® 568-R is recognized as a New Dietary Ingredient (NDI) by the US FDA, making it the only eligible RYR ingredient on the US market that can legally make claims and clearly specify the contents of its active compounds.

The only company that assists US Pharmacopeia in establishing the RYR monograph

From 2018 to 2022, a significant development is our pioneering assistance with the US Pharmacopeia (USP) for PF48(6) monographs to establish industry standards for red yeast rice products. This milestone not only highlights our commitment to quality but also marks a significant advancement in RYR dietary supplement standards.