Quality
Antares vitamin E TPGS is manufactured in full compliance with current Good Manufacturing Practices (cGMPs) and the United States Pharmacopeia (USP) monograph. It meets all applicable regulations and guidelines for use in pharmaceutical, dietary supplements, food and beverage, personal care and animal nutrition and health products. See our cGMP and Food Safety Statement.
The Antares Team is fully committed to meeting and exceeding quality standards when delivering clinically tested, safe and efficacious products to our customers.
SAFETY & STABILITY
Proven safe and effective, Antares Vitamin E TPGS is used around the world to safely improve the bioavailability of key ingredients in pharmaceuticals, supplements, beverages & food, and more.
HANDLING PROTOCOL
Available in multiple grades, Pharmaceutical Grade (NF), Food Grade (FG), and Sunflower TPGS™ (non-GMO) in both NF and FG grades. General instructions for handling and basic use for all grades are found below.
TPGS MANUFACTURING
Antares Vitamin E TPGS is manufactured under current Good Manufacturing Practices (cGMP) 21 CFR 210, as well as the International Pharmaceutical Excipients Council (IPEC) Good Manufacturing Practices Guide for Pharmaceutical Excipients (IPEC-PQG GMP). TSE GMP.
REGULATORY COMPLIANCE
Antares Health Products observes regulatory standards domestically and around the world.
Quality is Our #1 Priority
Corporate Quality
Antares is committed to promoting a quality-focused culture that ensures our highest priority is placed on the safety, efficacy, and reliability of our products. Our employees are always striving to maintain and grow this culture with innovative systems and processes that drive procedures, and guarantee decision-making is based on what is best for the product, the customer, and our prestige as a leader in the industry.
Our Quality Policy is implemented through a comprehensive Quality Management System. Performance is monitored and regularly reviewed to ensure our conduct meets and exceeds our customers’ expectations.
GMP Quality
Our manufacturing staff is dedicated to producing an excellent product that is cGMP compliant and exceeds the industry standards in purity and efficacy. Our cGMP manufacturing facility is compliant with EU GMP Part II, ICH Q7, ISO 9001, ISO 14001, and ISO 45001. The quality system is implemented by Quality Assurance, Quality Control, and IT Management & Compliance Units. Our facility is regularly inspected by US-FDA, Italian AIFA, and Japanese PMDA.
GDP Quality
Ensuring the quality, safety and compliance of our products doesn’t end once they have been released. The Antares quality system is an essential component in every stage of the production process, from sourcing raw materials until the product has been received by our customers. To this end, Antares exercises good storage practices as well as good distribution practices as defined by IPEC GDP.