At PanTheryx, we research, develop and commercialize medical nutrition products, globally.
PanTheryx has developed a proprietary, patent-pending, medical nutrition technology platform. Based on this platform, we develop innovative product compositions designed to meet the special nutritional requirements that promote intestinal health.
Our lead medical nutrition products are specially formulated to address the specific dietary needs of children with infectious diarrhea, resulting from a variety of sources. The nutritional deficiencies and malnutrition resulting from diarrhea have been extensively researched, are well-established and understood by the medical community. PanTheryx products have been shown in open-label clinical trials to be effective in addressing the nutrient needs of children with infectious diarrhea, which results in the restoration of intestinal health and function.
PanTheryx’s medical nutrition products fall into three specific regulatory categories that govern how they are classified and marketed in various countries. In the US, the FDA has oversight of these categories, which include Medical Foods, Foods for Special Dietary Use and Dietary Supplements. In Europe, Foods for Special Medical Purposes are regulated by the European Commission (EC). Other countries have similar regulatory oversight for nutritional products.
Foods for special dietary use are intended to address the particular dietary needs that exist by reason of a physical, physiological, pathological, or other condition, including but not limited to the condition of disease. Foods for special dietary use provide dietary nutrients intended to meet special nutritional needs of a condition or disease. All nutritional ingredients must be GRAS (Generally Recognized as Safe), prior sanctioned ingredients or approved food additives.
Medical foods differ from normal foods in that they are specifically tailored and targeted to the management of a specific disease for which there is a unique nutritional requirement that cannot be met or obtained through a normal diet alone or through dietary supplementation.
Medical foods and foods for special dietary use categories differ from products categorized as dietary supplements. Dietary supplements are intended to supplement healthy individuals with specific nutrients; however, they are not intended to provide nutritional support for a particular disease or physiological condition.
Foods for special dietary use, medical foods and dietary supplements must have scientific substantiation for claims related to the product.
In order to be compliant with regulatory requirements globally, PanTheryx follows local regulatory and legal requirements in each country of distribution.
PanTheryx has established global manufacturing positions necessary to support product requirements and the growing needs of our customers.
Commercial-scale production is carried out in both the United States and Malaysia, enabling product to be supplied efficiently on a regional basis. Manufacturing facilities operate in compliance with all applicable current Good Manufacturing Practices (cGMPs) and are readily expandable to rapidly increase production capacity.
At PanTheryx, manufacturing is performed in compliance with applicable local laws and regulations.
PanTheryx has established a comprehensive intellectual property strategy, which includes multiple global patent filings, trade secrets and trademark protection for our brands. The strategy employed allows for the global development and protection of a sustainable business enabling the creation of long-term shareholder value.