WILSON, North Carolina–(BUSINESS WIRE)–Averix Bio today announces the submission of a Drug Master File (DMF) to the United States Food & Drug Administration (FDA) for cannabidiol (CBD) isolate. Unlike most manufacturers, the ingredients of Averix are not synthetic but made from phytocannabinoid industrial hemp. The submission (DMF 036798) signifies Averix Bio’s commitment to bringing the highest quality ingredients to clinical trials and to the pharmaceutical, cosmetic, nutraceutical and veterinary markets.
Averix Bio is a large-scale producer of API pharmaceutical cannabinoid ingredients for international markets. Averix Bio’s manufacturing facility is compliant with current Good Manufacturing Practices (cGMP), meeting U.S. and international industry standards for ingredient and pharmaceutical manufacturing, including 21 CFR Parts 210 compliance /211 and ICH Q7. A Level 200 GMP compliant manufacturer will have strong quality management systems, rigorous operational testing, high quality raw materials and certified testing laboratories. Additionally, Averix Bio operates a detailed cultivation program, ensuring that its industrial hemp is locally grown, non-GMO, sustainably grown, and carefully tracked starting with soil and genetics.
“Averix Bio was designed to be a premier ingredient partner for pharmaceutical and other companies who want consistent and reproducible materials. Our strict processing and quality control departments ensure our partners reduce risk in their supply chain. source and work with a company that is committed to our motto – traceable, transparent and trustworthy. Unlike most companies, our materials actually start with a cultivation program focused on soil and hemp genetics, ending under form of active pharmaceutical ingredients (APIs). I couldn’t be more proud of our team, the long hours spent filing a DMF, and the internal commitment to quality,” said Miles Wright, CEO of Averix Organic.
About Averix Bio
Averix Bio is an American cannabinoid research and extraction company that produces phytocannabinoid ingredients that comply with 21 CFR Part 210 and Part 211 and ICH Q7 cGMP API standards. The company offers the highest quality cannabinoid ingredients for the pharmaceutical, nutraceutical, food and beverage, cosmetic and veterinary industries. Averix Bio guarantees consistent quality from seed to shelf, forming the cornerstone of a business foundation built on traceability, transparency and trust. Led by a world-class team with decades of cGMP and pharmaceutical experience, Averix Bio is on a mission to bring healthier cannabinoid-based medical solutions to patients around the world. For more information, email Miles Wright ([email protected]) or contact the company at +1 252-220-0887.