The relationship enables the team to benefit from growing demand for CBD in the region and will facilitate distribution of the active pharmaceutical ingredient (API) across Europe.
Kreglinger supplies a wide range of quality ingredients to manufacturers in the region, but this is the company’s first venture in the CBD market.
Key in the decision-making process was the US producer’s Food & Drug Administration (FDA) registered status which would appease customer concerns about product safety, says Kerlinger Europe Chief Executive Officer, Wim Amounts.
“Regulatory and safety concerns are always an issue for new products entering the market. To minimise risk, companies will choose ingredients that provide high compliance standards to meet quality and safety requirements.”
He explains that Kreglinger has been thinking about entering the cannabinoid market for a while but had not been able to identify a supplier that had the high standards it felt were required in order to do so.
“With demand for CBD products on the rise, we plan to meet the needs of our customers with the best ingredients available. We have been interested in the cannabinoid space for some time but had not found a supplier with the rigorous compliance standards that we felt necessary to enter the market.”
Quality CBD
Averix Bio CBD isolate is made from phytocannabinoid industrial hemp and developed using a comprehensive cultivation programme to ensure hemp is locally grown, non-GMO, sustainably farmed and traceable.
Manufacturing facilities comply with current good manufacturing practices (cGMP) and US and international standards for pharmaceutical ingredient and product manufacturing.
An on-site analytical lab in North Carolina allows for precise testing and efficient quality control at each step of the refinement process.
Averix Bio Chief Executive officer, Miles Wright, said: “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.”
Product integrity
The company submitted a Drug Master File (DMF) to the FDA for cannabidiol isolate to support regulatory requirements and secure intellectual property rights.
DMFs are submitted at the discretion of the holder and provide confidential information about facilities and manufacturing processes, however they are not required by law.
Kreglinger Europe’s current portfolio of ingredients include krill oil, red yeast rice, and oyster mushroom extract, and supplies customers in the pharmaceutical, food, cosmetic, supplements, chemical, and drinks industries.
Products are designed to refine specific characteristics of end products, such as improve flavour and product integrity, mask unpleasant tastes, and increase nutritional content, and include natural and organic ingredients.
The deal follows a recent announcement by the European Commission on standardised maximum levels for the psychotic compound delta-9-tetrahydrocannabinol (THC) found in CBD products, which industry association (the European Industrial Hemp Association) said would increase competition and promote growth in the sector.
Guidelines on the new regulations will be released in the Commission amended Regulation (EC) 1881/2006.