Averix Bio Announces Submission of Drug Master File for its CBD Isolate in the U.S.
Averix Bio today announces its submission of a Drug Master File (DMF) to the US Food & Drug Administration (FDA) for cannabidiol (CBD) isolate. Unlike most manufacturers, Averix ingredients are not synthetic but instead made from phytocannabinoid industrial hemp. The submission (DMF 036798) signifies Averix Bio’s commitment to bringing the highest quality ingredients to clinical trials and the pharmaceutical, cosmetics, nutraceutical and veterinary markets.
Averix Bio is a large-scale producer of pharmaceutical API cannabinoid ingredients for international markets. Averix Bio’s manufacturing facility complies with current good manufacturing practices (cGMP), meeting U.S. and international industry standards for pharmaceutical ingredient and product manufacturing, including 21 CFR Parts 210/211 compliance and ICH Q7. A manufacturer that is 200-level cGMP compliant 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, thereby ensuring its industrial hemp is locally grown, non-GMO, sustainably farmed and carefully tracked starting with soil and genetics.
“Averix Bio was built to be a tier one ingredient partner for pharmaceutical and other companies who want 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. 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,” said Miles Wright, Chief Executive Officer at Averix Bio.
About Averix Bio
Averix Bio is a U.S.-based cannabinoid research and extraction company producing 21 CFR Part 210 and Part 211 and ICH Q7 compliant cGMP API phytocannabinoid ingredients. The company offers the highest-quality cannabinoid ingredients for use in the pharmaceutical, nutraceutical, food and beverage, cosmetic and veterinary sectors. Averix Bio ensures consistent quality from seed-to-shelf, forming the cornerstone of a corporate 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 (miles@averixbio.com) or contact the company at +1 252-220-0887.
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Contact information
Miles Wright
miles@averixbio.com
+1 252-220-0887
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