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Quality & Regulatory Support

Our CRDMO / CDMO / CMO services ensure global standards and regulatory compliance by integrating quality control, regulatory strategy, and documentation—covering everything from raw materials to finished products.

Quality & Innovation
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Certifications

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Patents

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Research Publications

Global Presence & Recognition
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Awards

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Countries Reached

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Products

What We Ensure

Quality Assurance Procedures

Step 1

Management and Control of Ingredients and Materials

Each lot of the purchased ingredients and materials will be allowed to be applied in product manufacturing after being tested and approved.

Step 2

Management and Control of Manufacturing Procedures

Hazard Analysis and Critical Control Points has been set up in order to supervise operational conditions during product manufacturing procedures.

Step 3

Product Examination

Each lot of products will be qualified for delivery after being tested and approved by the Department of Quality Assurance.

Step 4

Sample Retention

To protect the rights and interests of customers, sample products from each lot will be retained in the sample room for future reference in case of any abnormalities.

Step 5

Regular Management and Control

Equipment maintenance, colony-forming unit surveillance in the operational area, the hand hygiene of operational staff, water quality tests, and apparatus calibration.

What We Provide

Quality Assurance of Ingredients

Strain Identification & Validation

Closed-System Sterile Fermenter

FDA NDI / GRAS Application Support

Whole Genome Sequencing

Strain Identification Method Designing

Strain Identification of Powder

What We’ve Earned

Certifications

Safety Guarantee

FDA NDI (#1071)

Free from Monacolin K

Citrinin is not detected

Safety Assessment

International Certifications

USP Monograph

SGS ISO 22000

SGS HACCP

GMP

Product Integrity

nongmo

Non GMO

Gluten Free

Vegan & Vegetarian

HALAL Certification

SNQ

Taiwan's Health Food Certificate (Blood Lipids)

Taiwan's Health Food Certificate (Blood Sugar)

Taiwan's Health Food Certificate (Anti-Aging)

NFSA of Egypy

Italian Food supplement (137602, 137372)

Health Canada NPN (80091703、80125942)

Malaysia MAL (MAL20021445T、 MAL07031236T)

What We’ve Patented

Patents

01

Method for Manufacturing Composition for Lowering Blood Lipid and Elevating High Density Lipoprotein

Taiwan, USA, Canada, Japan, EU, France, Germany, Italy, India, China

03_專利證書-日本-一種可降血脂且提升高密度脂強白膽固醇之組合物及其製造方法-100-I-SW-005(JP).jpg 的副本
05_專利證書-加拿大-一種可降血脂且提升高密度脂強白膽固醇之組合物及其製造方法(Monascin)-100-I-SW-005(CA).jpg 的副本
04_專利證書-加拿大-一種可降血脂且提升高密度脂強白膽固醇之組合物及其製造方法(Ankaflavin)-102-DIV-SW-005-1(CA)_頁面_1.jpg 的副本
06_專利證書-EU-歐盟代表-一種可降血脂且提升高密度脂強白膽固醇之組合物及其製造方法-100-I-SW-005(EU).jpg 的副本
07_專利證書-EU-法國-一種可降血脂且提升高密度脂強白膽固醇之組合物及其製造方法-100-I-SW-005(EU).jpg 的副本
08_專利證書-EU-德國-一種可降血脂且提升高密度脂強白膽固醇之組合物及其製造方法-100-I-SW-005(EU)_頁面_1.jpg 的副本
09_專利證書-EU-義大利-一種可降血脂且提升高密度脂強白膽固醇之組合物及其製造方法-100-I-SW-005(EU)_頁面_1.jpg 的副本
10_專利證書-印度-一種可降血脂且提升高密度脂強白膽固醇之組合物及其製造方法-100-I-SW-005(IN).jpg 的副本
11_專利證書-美國-一種可降血脂且提升高密度脂蛋白膽固醇之組合物及其製造方法-101-DIV-SW-005.1(US)_頁面_1.jpg 的副本
12_專利證書-美國-一種可降血脂且提升高密度脂蛋白膽固醇之組合物及其製造方法-101-DIV-SW-005.2(US)_頁面_1.jpg 的副本
01_專利證書-台灣-一種可降血脂且提升高密度脂強白膽固醇之組合物及其製造方法-100-I-SW-005(TW).jpg 的副本
02_專利證書-大陸-一種可降血脂且提升高密度脂強白膽固醇之組合物及其製造方法-100-I-SW-005(CN).jpg 的副本
02

Composition for Reducing Blood Pressure and Primer Set for Monascus purpureus NTU 568

Taiwan

14_專利證書-台灣-紅麴山藥於製備用以降低血壓之組合物的用途-102-I-SW-008(TW)_頁面_1.jpg 的副本
13_專利證書-台灣-用以降低血壓之組合物及Monascus purpureusNTU568的引子組-104-I-SW-008.1(TW).jpg 的副本
03

Use of Monascus-Fermented Product and Its Secondary Metabolites in Preparing a Composition for Regulating Blood Glucose

Taiwan, USA, India

17_專利證書-印度-紅麴發酵產物及其次級代謝物於製備調節血糖之組合物的用途-104-I-SW-012(IN)-1.jpg 的副本
16_專利證書-美國-紅麴發酵產物及其次級代謝物於製備調節血糖之組合物的用途-107-CA-SW-012-1(US)_頁面_1.jpg 的副本
15_專利證書-台灣-紅麴發酵產物及其次級代謝物於製備調節血糖之組合物的用途-104-I-SW-012(TW)_頁面_1.jpg 的副本
04

Method for Manufacturing Composition for Treating and Preventing Alzheimer's Disease

Taiwan

18_專利證書-台灣-治療及預防阿茲海默症(正式版)-96-I-SW-001(TW).jpg 的副本
19_專利證書-台灣-治療及預防阿茲海默症-99-I-SW-007(TW).jpg 的副本
What We Validate

Clinical Research Publications

A randomized, double-blind clinical study of the effects of Ankascin 568 plus on blood lipid regulation

A randomized, double-blind clinical study to determine the effect of ANKASCIN 568 plus on blood glucose regulation

A randomized, double-blind clinical study on blood pressure reduction and blood lipid profile amelioration on treatment with Ankascin 568

Effects of Vigiis 101-LAB on a healthy population's gut microflora, peristalsis, immunity, and anti-oxidative capacity

What We’ve Achieved

Awards

05.28.2024

Exciting News! XYMOGEN Red Yeast Rice has been recognized as a finalist for the Nutraingredients USA Awards 2024!

04.17.2024

President Commends SunWay Biotech as ANKASCIN® 568-R Red Yeast Rice Extract Wins SNQ Bronze Award

02.04.2024

Remarkable Achievement! ANKASCIN® 568-R Wins Bronze in SNQ National Quality Mark Evaluation!

12
2025.03
03.12.2025

SunWay Biotech Awarded Recognition by the USP for Contributions to Red Yeast Standards

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CDMO Service Overview
Ingredient Development & Manufacturing
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