APIRx Pharmaceuticals USA

APIRx is part of a large and rapidly growing market opportunity in global cannabis consumption for medicinal use, continuously being reforecasted due to regulatory adoption at both state and federal levels (in certain countries/regions). While some companies have obtained cGMP certification for certain manufacturing processes, APIRx is the first company to offer APIs and finished products based on an end-to-end cGMP process, starting with cGMP-produced cannabis plants.Current products are based on cGMP synthetic cannabinoids (THC and CBD), but these are very expensive and prone to manufacturing errors, which can be harmful. The production of synthetic cannabinoids is a costly multi-step process where even the slightest error could lead to catastrophic consequences. This is not the case for naturally derived cannabinoids. Currently, there are two regulated (EMA, FDA, etc.) products based on natural extraction of cannabinoids: Sativex (THC and CBD) and Epidiolex (CBD). This marks a shift in the FDA’s stance and regulatory willingness toward naturally extracted cannabinoids.Therefore, cannabinoid-based pharmaceuticals and nutraceuticals will be subject to regulation, with strict guidelines for acceptability (i.e., they must comply with cGMP standards). APIRx's cGMP natural cannabis plant products will provide the market with lower costs and enhanced consumer safety.