An American cannabinoid research and extraction company has submitted documents to the United States Food and Drug Administration (FDA) regarding manufacturing and other related processes.
Wilson, North Carolina-based Averix Bio today announced that it had submitted a Drug Master File (DMF) for its cannabidiol (CBD) isolate to the FDA.
Averix says its DMF submission (DMF 036798) demonstrates its commitment to bringing the highest quality ingredients to clinical trials and the pharmaceutical, cosmetic, nutraceutical, and veterinary markets.
Averix CEO Miles Wright says the company is built to be a tier-one ingredient partner for pharmaceutical and other companies that need consistent, repeatable materials.
“Our strict processing and quality control departments ensures our partners de-risk their supply chain and work with a company committed to our motto—trackable, transparent, and trustworthy,” says Wright. “Unlike most companies, our materials actually starts with a cultivation program focused on soil and hemp genetics, ending up as active pharmaceutical ingredients(APIs). I could not be more proud of our team, the long hours pursuing a DMF filing, and the internal commitment to quality.”
A large-scale pharmaceutical API provider for international markets, Averix says its manufacturing facility is good manufacturing practices (GMP) compliant.
Averix says the facility meets international pharmaceutical ingredient and product manufacturing industry standards, including 21 CFR Parts 210 and 211 compliance and ICH Q7.
According to Averix, 200-level CGMP compliant companies have strong quality management systems, rigorous operational testing, high-quality raw materials, and certified testing labs.
Averix says its detailed cultivation program ensures its industrial hemp is grown locally, non-GMO, farmed sustainably, and carefully tracked with soil and genetics.