The red yeast rice raw material ANKASCIN 568-R, manufactured by SunWay Biotech Co., Ltd. (herein after “SunWay”), undergoes a rigorous production process. Here below are the key points SunWay declares:

1. Local Rice Sourcing: The fermentation white rice used in ANKASCIN 568-R is sourced from local Taiwanese rice merchants through contractual agreements. This ensures traceability and quality control.
2. Exclusive Patented Solid-State Fermentation Process: The unique patented solid-state fermentation process is employed during production.
3. Certifications and Compliance:

• The production facility in Taiwan adheres to the Good Manufacturing Practice for Health Supplements (GMP) standards set by the Taiwan Food and Drug Administration. And SunWay holds GMP certification.
• SunWay also holds ISO22000 and HACCP certifications.
• The entire production process takes place in a sterile, closed, and fully automated fermentation facility.
• No external red yeast rice raw materials are added, eliminating concerns about blending with materials from other sources, including Japanese manufacturers like Kobayashi Pharmaceutical Company Ltd.

4. Human Clinical Trials and Safety Monitoring:

• ANKASCIN 568-R has undergone multiple human clinical trials.
• Safety indicators have been monitored in over 200 participants, confirming its safety for liver and kidney function.
• It is the only red yeast rice product to receive New Dietary Ingredients (NDI) certification from the U.S. FDA, allowing it to legally indicate the content of active ingredients and be sold in the U.S.

5. Stringent Quality Control:

• SunWay follows international food safety standards throughout the production process.
• Scientific verification and rigorous screening ensure consistent quality.
• Third-party inspections by internationally accredited bodies verify that the product is free from microbial contaminants such as Staphylococcus aureus, Salmonella, and Escherichia coli, as well as industrial pollutants like preservatives and ethylene oxide.
• ANKASCIN 568-R complies with safety and hygiene regulations related to mycotoxins (citrinin), yellow mold toxins, heavy metals, and plasticizers. Additionally, it has been tested for the absence of 365 specific Western medicines.

6. Safety Testing:

• ANKASCIN 568-R has undergone long-term 90-day toxicity tests and genotoxicity tests, confirming its safety even at doses exceeding 200 times the recommended amount.
• Batch-to-batch consistency is ensured through a unique fingerprint pattern for monitoring any unidentified components.

In summary, SunWay prioritizes safety, quality, and scientific validation in the production of ANKASCIN 568-R red yeast rice raw material.

Hereby declare.

SunWay Biotech Co., Ltd.

 March 26, 2024