Regulatory Compliance
XYGENYX exclusively uses an FDA registered manufacturing facility and we comply with all FDA regulations. With our extensive experience in regulatory compliance of over-the-counter products, we can advise and assist with all requirements for FDA product indications, label copy, and ingredient listings. We also file the appropriate drug product listing with the FDA for all drug products manufactured for U.S. sales.
Product Consistency and Reliability
According to FDA instruction, XYGENYX documents every step of the manufacturing operation. We consistently produce products by using quality raw materials, applying strict product testing, and by using standardized manufacturing processes with each and every order.
Ingredients
Through our worldwide channel of ethical and reliable suppliers, we are able to acquire quality, raw ingredients. We use a USP state-of-the-art water purifying system for all of our non GMO, gluten free, organic alcohol.
Quality Control Testing
A quarantine of all inbound raw materials is mandatory until the quality and identity of those raw materials are verified. All raw material suppliers must provide Certificates of Analysis. During the manufacturing process, all water used undergoes microbiological testing in accordance with USP (United States Pharmacopeia) regulations. It is not until an extensive series of product testing is performed before the product is released.
Facilities
We use one of a small number of authorized homeopathic manufacturing facilities in the United States. XYGENYX is registered with and subject to inspection by the Food and Drug Administration (FDA). We follow all current good manufacturing practices (cGMPs) as set forth by the FDA.
