Taipei, Taiwan — In a significant milestone, SunWay Biotech proudly announces its recognition by the United States Pharmacopeia (USP) for its substantial contributions towards the standardization of red yeast rice and red yeast dry extract in USP PF48(6) monographs. This acknowledgement comes with the official appreciation and a certificate for participating in the USP’s standards-setting activities, highlighting SunWay Biotech’s pivotal role in achieving important milestones in 2022.

The United States Pharmacopeia, an independent, scientific nonprofit organization, has been a cornerstone in the promotion of health and safety through its commitment to quality and trust in the global supply of medicines, dietary supplements, and foods for over 200 years. By setting rigorous scientific and public quality standards, the USP plays a crucial role in protecting patient safety and enhancing global health outcomes.

The main efficacy compound of Red yeast rice is commonly known as Monacolin K, however, it is identical to the prescription drugs, lovastatin/statins. Therefore, since 1998, the US Food and Drug Administration (FDA) has classified red yeast rice products containing more than trace amounts of Monacolin K as unapproved new drugs, thus prohibiting their legal sale as dietary supplements in the United States. Additionally, new regulations by the European Union in 2022 have limited the content of Monacolins in red yeast rice products to not over 3 mg per daily dosage, emphasizing the need for stringent standards in dietary supplements.

As the fermented pioneer in the fermented industry, it is our honour to assist USP in the development of dietary supplement monographs for red yeast rice and red yeast dry extract. The recognition of SunWay Biotech by the USP not only marks a significant achievement for the company but also underscores the importance of collaborative efforts in setting public quality standards for health products. We aim to help USP protect individual safety with rigorous scientific and public quality standards worldwide.