SunWay Biotech Co., Ltd. focuses on the R&D of Monascus purpureus NTU 568 fermented products in collaboration with National Taiwan University (NTU). Over 130 SCI-indexed studies have been published, supporting the multifunctional health benefits of NTU 568. Research indicates its potential in improving dyslipidemia, hyperglycemia, hypertension, lipid accumulation, immune regulation, inflammation, tumors, Alzheimer’s disease, Parkinson’s disease, asthma, and liver disorders. Its key ingredient, Ankascin® 568-R, is produced with proprietary 2.5-ton automated fermentation technology Furthermore, adhering to the company’s core philosophy of “ Careful by the Company, Peace of Mind for Customers,” SunWay Biotech Co., Ltd. in the ISO 22000 & HACCP international certificated factory.
Niang Chia Red Yeast Rice Capsules has also successfully obtained health food certification for its effects in regulating blood lipids, regulating blood glucose, and delaying aging. It has been reviewed and approved by national authorities for its health benefits and complies with the required standards for dosage, specifications, and manufacturing processes, thereby ensuring product quality and safety and providing consumers with greater confidence. Therefore, the contestant has no equal in Taiwan and is one of the best healthy foods in the world. It is worthy to recommend sincerely to our compatriots. We have heartfelt hope that it could be another “The Pride of Taiwan“ in the future.
Ankascin® 568-R is a red yeast rice extract developed using a proprietary patented solid-state fermentation process. It is the first and only red yeast rice product on the market that does not contain monacolin K (statin-like compounds)., including increasing good cholesterol. The product has completed human clinical trials demonstrating efficacy in regulating blood lipids, blood pressure, and blood glucose. It has been reviewed by FDA and granted NDI status.
Ankascin® 568-R has obtained Halal certification from THIDA, which is aligned with major international Halal authorities, including JAKIM (Malaysia), BPJPH (Indonesia), and MUIS (Singapore). This ensures compliance with Islamic dietary laws, safeguards Muslim consumer rights, and strengthens hygiene, safety, and quality control across the production process. It also enhances product credibility and facilitates market expansion into Southeast Asia.
SunWay Biotech Co., Ltd. is certified by SGS with ISO 22000:2018 and HACCP, ensuring that all food safety and quality management systems are properly established and implemented. Production processes are standardized, operations follow Standard Operating Procedures (SOPs), and personnel training complies with relevant food safety regulations.
SunWay Biotech Co., Ltd. is also certified in GMP for health food supplements, establishing a comprehensive manufacturing and quality management system. maintaining product quality consistency and regulatory compliance.
Red yeast Fermented product extract, Corn Starch
Monascin ≧28 mg/g
Ankaflavin ≧9 mg/g
Manufacturer Name: SunWay Biotech Co., Ltd
Factory Registration No.: 65013048
Food Business Registration No.: F-128708250-00004-9
Control of Raw Materials
standards are established to regulate incoming raw material specifications and acceptance procedures, thereby ensuring the quality, safety, and compliance of finished products.
To effectively manage procurement operations, ensuring that materials required for production are supplied in the right time, quantity, price, and quality, standards are formulated to regulate procurement processes and to secure reliable sources and high-quality raw materials.
To ensure that products are manufactured in an orderly sequence from incoming materials through processing to shipment, and to improve production efficiency, standardized operating procedures are established for all production activities.
Through proper documentation and labeling, all personnel involved in production and distribution can clearly identify and correctly use raw materials, enabling traceability of the production process in case of abnormalities.
To ensure that products maintain stable quality within their shelf life, retention samples of finished products shall be kept for comparison, along with periodic monitoring and record-keeping.
To implement proper testing methods for quality analysis, and to monitor the quality of raw materials, semi-finished products, and finished products, thereby maintaining overall product quality.
Storage Operations To establish standardized procedures for warehousing and transportation of raw materials and finished products, ensuring proper storage management.
SunWay Biotech Co., Ltd, in addition to conducting batch-by-batch internal testing, also commissions accredited third-party laboratories to perform analyses on heavy metals (arsenic, lead, cadmium, and mercury), ethylene oxide, polycyclic aromatic hydrocarbons (PAHs), and verification of the absence of monacolin K.
These tests are carried out regularly to monitor and compare product quality, ensuring that no deviations occur. The company implements source control and process management based on quality specifications that exceed both industry standards and national regulatory requirements.
This approach not only safeguards consumer rights and corporate reputation, but also aims to achieve broad consumer trust and recognition.
Self-Inspection
This product, Ankascin® 568-R red yeast rice extract, conducts pathogen testing, including molds, yeasts, total coliforms, and Escherichia coli, to further ensure product safety.
In addition, citrinin, a major concern for consumers of red yeast rice products, is controlled at levels significantly below national regulatory limits. This product is also supported by qualified short-term and long-term toxicological safety studies, ensuring its suitability for long-term consumption.
Furthermore, testing for residual alcohol is conducted to ensure that consumers can use the product safely and with confidence.
Crisis Management System
To ensure the food safety, hygiene, and quality of SunWay Biotech Co., Ltd. products, for products that have been shipped and are already in circulation in the market, if it is confirmed that product quality may pose a health risk to consumers, a product recall shall be implemented within a specified timeframe to safeguard consumer health.
Customer Satisfaction
Customer complaint handling procedures are established to ensure that consumer complaints are properly resolved, fostering positive interactions with customers.
Quality Supervision
To verify that the company’s quality management system is effectively implemented and maintained, and to ensure the proper execution of internal quality audits, thereby fulfilling functions related to quality, hygiene, and safety management and achieving the objectives of the quality management system.
Ankascin® 568-R red yeast rice extract demonstrates the following three functional effects:
Lipid Regulation According to animal study results, the product: Helps reduce total cholesterol levels in serum Helps reduce serum triglyceride levels Helps increase high-density lipoprotein (HDL) and decrease low-density lipoprotein (LDL)
Blood Glucose Regulation Based on animal studies, the product provides a supportive effect in regulating blood glucose levels in subjects with elevated fasting glucose.
Anti-Aging Effect In induced aging animal models, the product demonstrated potential in delaying aging. Amyloid-β (Aβ) deposition leads to neuronal damage and ultimately results in Alzheimer’s disease (AD), while high cholesterol and high-calorie diets may exacerbate disease progression. Results showed that MS and AK supplementation significantly improved both reference memory and working memory in AD-induced rats (p < 0.05). Furthermore, MS and AK reduced the expression levels of phosphorylated tau protein, apolipoprotein E (apo E), and β-site amyloid precursor protein cleaving enzyme (BACE) in the hippocampus and cortex. These findings suggest that, in Aβ40-induced AD animal models, MS and AK may enhance memory and learning ability by inhibiting AD-related risk factors.
Yin-Ruei Wang, Sheng-Fu Liu, You-Cheng Shen, Chien-Li Chen, Chine-Ning Huang, Tzu-Ming Pan, Chin-Kun Wang. A randomized, double-blind clinical study to determine the effect of ANKASCIN 568 plus on blood glucose regulation. J Drug Food Anal. (2017) 25: 409-416.
Chen, C.L., Chang, K.Y., Pan, T.M. J Fun Food. (2016) 21: 167-177. Monascus purpureus NTU 568 fermented product improves memory and learning ability in rats with aluminum-induced Alzheimer's disease.
Chun-Lin Lee, Ja-Yan Wen, Ya-Wen Hsu, Tzu-Ming Pan. J Microb Immun Infect. (2018) 51: 27-37. The blood lipid regulation of Monascus-produced monascin and ankaflavin via the suppression of low-density lipoprotein cholesterol assembly and stimulation of apolipoprotein A1 expression in liver.
Chinese Title: 一種治療與預防阿茲海默症之組合物及其製作方法 English Title: Composition and Method for Prevention and Treatment of Alzheimer’s Disease
A composition for the prevention and treatment of Alzheimer’s disease, comprising an anti-inflammatory substance, and an antioxidant substance, wherein the composition is extracted from red yeast rice.
Chinese Title: 一種可對抗體脂肪形成之紅麴生成成份組合物及其製作方法 English Title: Composition of Monascus-Fermented Product with a Function of Reducing Body Fat Formation and Method for Manufacturing the Same.
The present invention discloses a composition of Monascus-fermented products capable of reducing body fat formation and a method for manufacturing the same. The composition is prepared using rice as raw materials. The manufacturing process involves the use of water and alcohol as solvents to facilitate fermentation. The resulting Monascus-fermented composition has been demonstrated, through in vitro studies and animal experiments, to effectively inhibit body fat formation
