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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220223005389/en/
Contact information
Miles Wright
miles@averixbio.com
+1 252-220-0887
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
From Ancient Grounds to an Intelligent Future: The 1st International Humanoid Olympiad Launches in Olympia, Greece29.5.2025 01:47:00 EEST | Press release
This year, Olympia, Greece, the birthplace of the Olympic Games, welcomes the inaugural International Humanoid Olympiad. From August 29th to September 2nd, at the International Olympic Academy in Olympia, humanoid robots will participate in demonstrations and Olympic-inspired games, showcasing their dexterity and intelligence, while global leaders in robotics and AI will share insights through expert talks and workshops. Blending millennia-old values, ethos, and ideals with a bold vision for the future, the event will spotlight how human creativity and robotics are shaping the future. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250528788233/en/ This global gathering brings together state-of-the-art humanoid robots in spectacular showcases designed to captivate audiences of all ages and backgrounds while their creators, researchers, engineers, students, and visionaries are pushing the boundaries of what intelligent machine
Mary Kay Inc. Awards 10 Grants to Young Innovators at 2025 Regeneron International Science and Engineering Fair28.5.2025 23:29:00 EEST | Press release
Mary Kay Inc., a global advocate for furthering young women’s education and encouraging youth to follow their STEM dreams, returned for a second year as a Special Awards Organization at the Regeneron International Science and Engineering Fair (Regeneron ISEF) in Columbus, Ohio. Ten grants totaling nearly $10,000 were awarded to standout high school-aged students excelling in innovative projects spanning topics from finding cures for cancers affecting women to sustainable packaging innovation and protecting our planet’s most valuable resources. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250528325390/en/ Kristin Dasaro, Director, Package Engineering and Sustainability at Mary Kay, greets Brazilian cancer researcher, Carolina de Araujo Pereira da Silva, who received back-to-back awards from Mary Kay for innovative findings in the malignancy of tumors. (Photo Credit: Mary Kay Inc.) Each year, the event convenes nearly 2,000
Duravant Completes Acquisition of Pattyn28.5.2025 20:44:00 EEST | Press release
Duravant LLC (“Duravant”), a global engineered equipment and automation solutions provider to the protein processing, food sorting and handling, packaging, and material handling sectors, announced the completion of its acquisition of the Pattyn Group BV (“Pattyn”), a leading manufacturer of packaging automation systems headquartered in Bruges, Belgium. The transaction was first announced on February 7, 2025, and was completed today. With over 70 years of expertise, Pattyn is a trusted partner for companies looking to automate bulk packaging operations in industries ranging from food and ingredients to non-food applications. Pattyn has been a world-renowned brand specializing in bag-in-box packaging technology, and their comprehensive end-of-line solutions span the entire packaging process from case erecting and bag inserting to weigh filling, bag and case closing, and palletizing. “We are extremely excited to welcome Pattyn to the Duravant family,” said Mike Kachmer, Chairman and CEO o
Rimini Street Appoints Vijay Kumar as EVP and Chief Operating Officer28.5.2025 19:00:00 EEST | Press release
Rimini Street, Inc. (Nasdaq: RMNI), a global provider of end-to-end enterprise software support, management and innovation solutions, and the leading third-party support provider for Oracle, SAP and VMware software, today announced the appointment of Vijay Kumar as executive vice president (EVP) and chief operating officer (COO). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250528704180/en/ Rimini Street Appoints Vijay Kumar as EVP and Chief Operating Officer In this role, Mr. Kumar leads product management, service strategy and offerings for Rimini Street’s “Support, Optimize and Innovate” solutions and oversees Rimini Street’s Global Capability Centers (GCC). Mr. Kumar also drives operational efficiency and innovation of the portfolio to increase profitability and accelerate top line revenue growth. New COO Brings Broad Operational Experience and Capabilities Kumar is a seasoned technology executive with more than 25 yea
Cargill Earns #1 Global Ranking for Removing Trans Fats From Edible Oils Portfolio28.5.2025 18:12:00 EEST | Press release
Cargill earned the top spot on the inaugural Edible Oil Supplier Index 2025, published by global nonprofit Access to Nutrition initiative (ATNi). The ranking recognizes the company’s leadership in removing industrially produced trans-fatty acids* (iTFAs) from its entire edible oils portfolio, even in markets with no regulatory mandate. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250528074187/en/ Cargill earned the top spot on the inaugural Edible Oil Supplier Index 2025, published by global nonprofit Access to Nutrition initiative (ATNi) Cargill’s leadership in this space has made a tangible difference for customers and consumers around the world. Chantilly, a cherished brand in Mexico known for its bakery, pastry and confectionery products, is a standout example. The company credits Cargill as a key ally in helping remove iTFAs from its popular whipping cream recipes. “Cargill provided the expertise and technology needed
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom