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Product Description

Product Features and Manufacturing Technology This product is developed on a medical evidence–based platform. Its core ingredient technology is derived from the development experience of “Zelnite®,” a TFDA-approved prescription product for selenium supplementation.
SelenOne® is manufactured under pharmaceutical-grade quality management systems, including:
-Production in GMP-compliant manufacturing facilities.
-Strict environmental and process controls.
-Comprehensive batch record management.
-Equipment cleaning and process validation systems.
-Enhanced testing for heavy metals, microbiological safety, and product consistency.
By integrating pharmaceutical-grade manufacturing concepts into nutritional ingredient development, SelenOne® provides a high-quality, stable, and reliable source of selenium supplementation.

Health Benefits and Nutritional Support
Selenium is an essential trace element and an important component of antioxidant enzymes in the human body. Scientific studies suggest that adequate selenium supplementation may help support: 
-Antioxidant defense and reduction of oxidative stress 
-Normal immune function and metabolism
-Skin health and vitality 
-Cardiovascular, liver, and thyroid health 
Daily nutritional balance and overall wellness Selenium has also been widely studied in the fields of antioxidant research, nutritional support, and preventive health applications.

 


Ingredients

Sodium Selenite Pentahydrate

 


Active Ingredient Content

According to the Ministry of Health and Welfare (MOHW) in Taiwan, the recommended daily intake of selenium for healthy adults is 55 μg per day, with a suggested upper intake level not exceeding 200 μg per day.

 


Manufacturer

Formosa Laboratories, Inc.

 

QC Implementation

TaiRx has established a comprehensive Quality Control (QC) system covering raw material inspection, in-process control, and finished product release to ensure product quality and safety. Incoming materials are inspected by the contracted manufacturer, Formosa Laboratories, Inc., to verify identity, purity, assay, and other quality specifications before manufacturing use. Production activities are conducted in compliance with GMP requirements, with critical process parameters monitored throughout manufacturing. Routine QA inspections and process audits are performed to ensure batch consistency and minimize quality risks. Any deviations are investigated through CAPA procedures for timely corrective actions. Finished products are tested according to international pharmacopeial standards and applicable regulations before release, including assay, appearance, heavy metals, and microbiological testing. Retention samples, stability monitoring, supplier qualification, document control, and personnel training programs are also maintained to support product quality, traceability, and continuous improvement.


Quality & Safety Testing

TaiRx places great emphasis on product quality and safety management by establishing a comprehensive quality and safety testing system covering raw materials, manufacturing processes, and finished products. Incoming raw materials are inspected by the contracted manufacturer, Formosa Laboratories, Inc., to verify identity, purity, assay, appearance, and other quality attributes before being approved for production use. During manufacturing, all operations are conducted in accordance with GMP quality management requirements, with QA personnel performing process monitoring and routine inspections to ensure compliance with hygiene and production standards. Upon completion of manufacturing, finished products undergo release testing based on international pharmacopeial standards and food additive regulations, including tests for assay, appearance, heavy metals, and microbiological specifications before release for distribution. In addition, third-party testing laboratories are periodically commissioned to perform safety-related analyses to ensure the objectivity and reliability of product quality evaluations. Retention samples and ongoing stability studies are conducted for each batch to support product traceability and complaint investigations. Through this comprehensive quality and safety testing system, product quality and safety are maintained throughout manufacturing, storage, and usage.


Risk Management System

TaiRx has established a comprehensive risk management system covering raw material inspection, manufacturing control, product release, and post-market surveillance to ensure product quality, safety, and stability. The contracted manufacturer, Formosa Laboratories, Inc., performs strict incoming inspections of raw materials and packaging components to minimize quality risks. Manufacturing activities are conducted in compliance with GMP and relevant quality standards. Critical process parameters, in-process inspections, and routine QA audits are implemented to ensure batch consistency and product reliability. Any abnormalities or deviations are managed through a CAPA system for root cause investigation and corrective actions. Finished products are tested according to international pharmacopeial standards and applicable regulations prior to release. Retention samples and stability monitoring are maintained to support product traceability and complaint investigations. TaiRx also collects customer feedback and market information to maintain effective post-market quality surveillance. Product education and usage guidance are provided to reduce risks associated with improper handling or use, while continuous communication with manufacturers and customers supports ongoing quality improvement and risk management.

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Functional Health Ingredients

TaiRx Selenium Mineral Supplement: SelenOne®

SelenOne® is Taiwan’s only sodium selenite pentahydrate ingredient approved with both TFDA food additive and API licenses, meeting pharmaceutical-grade standards and registered in the US FDA DMF.
Organization
TaiRx.Inc
Certification Year
2022、2023、2024、2025
TaiRx Selenium Mineral Supplement: SelenOne®