Pharmaceutical, nutraceutical and cosmetic companies can now secure API Phytocannabinoid CBD isolate for preclinical research, clinical trials and manufacturing
Averix Bio is proud to announce that it has successfully completed an independent audit for 21 CFR Part 210 and Part 211 cGMP compliance of API phytocannabinoid CBD isolate in the U.S. as well as for ICH Q7 standards.
“This is an historic milestone for Averix Bio, the biopharmaceutical sector and the CBD industry,” said Miles Wright, CEO of Averix Bio. “By reaching the FDA’s rigorous criteria for producing active pharmaceutical ingredients, Averix is proud to help drive research, launch APIs and finished products, and collaborate with partners as a science-driven manufacturer that minimizes supply-chain risk. We will partner with life science and other companies exploring the use of cannabinoids in their products and research.”
The compliance audit was conducted by the ProPharma Group, a leading global, independent, single-source provider of regulatory, clinical and compliance services serving pharmaceutical, biotechnology and medical device companies.
The Averix quality assurance team has more than six decades of cGMP pharmaceutical experience from preclinical and clinical research through commercial production at firms such as GSK, Pfizer, Novartis, Roche and Genentech. “The depth and breadth of our team’s life science experience provide peace-of-mind for scientists and pharmaceutical manufacturers that need materials that meet FDA standards,” Mr. Wright said.
Located in North Carolina’s Research Triangle region, the company operates the largest industrial hemp research, extraction and production company in the eastern U.S. with a 200,000-square-foot facility on a 36-acre campus. The site comprises research and production suites, analytical testing laboratories, and climate-controlled biomass storage facilities.
Since its launch in 2018, Averix has built a global footprint for its products, exporting a range of ingredients to countries on multiple continents. In addition, Mr. Wright highlighted Averix Bio’s proprietary 2021 hemp cultivation program that the company is currently conducting. “Averix is pioneering a fully transparent and highly controlled program with select industrial hemp farmers and genetic companies to gather data on genetics, nutrients, organic practices and the benefits of heightened consistency and quality management,” he noted.
“Averix will be the ingredient partner of choice for manufacturers in multiple sectors looking for a tier 1 vendor,” said Mark Ward, Vice President of Sales and Marketing. "Most companies are very interested in reducing their supply chain risks – Averix is your insurance policy.”
“Averix Bio is a science-driven company dedicated to companies who need a highly compliant manufacturing partner,” said Mr. Wright. “This third-party audit validates our deep commitment to provide safer and more efficacious ingredients for pharmaceutical and nutraceutical products that can benefit patients in need.”