LUXEMBOURG--(BUSINESS WIRE)--Eurofins CDMO Alphora Inc. announces that it has received its Health Canada Cannabis Drug License issued within the Cannabis Act and Cannabis Regulations for its Oakville, Ontario operations in September 2023. This compliments the Institutional Research License obtained through Health Canada in June 2021 for its Mississauga development site and a Standard Processing License obtained for the Oakville, Ontario manufacturing operation in May 2022.
With the new Cannabis Drug License, Eurofins CDMO Alphora can supply cGMP grade Cannabinoids for use in Drug therapies. Eurofins CDMO Alphora operations are approved by Health Canada and the FDA and have manufactured clinical stage and commercial-stage APIs since 2008. The Cannabis Drug License now extends these cGMP capabilities into the cannabinoid therapeutic market.
Eurofins CDMO Alphora Inc. entered a licensing agreement with Kare Chemical Technologies Inc. in August 2021 to use of Kare’s innovative technology to synthetically produce high quality phytocannabinoids. Eurofins CDMO Alphora Inc. has since developed scalable processes for several naturally occurring phytocannabinoids including CBD, CBDv, THC, THCv, and CBN. Eurofins CDMO also offers high quality reference standards for these and other niche cannabinoids as well as C13 labelled cannabinoids to support product development and testing.
Eurofins CDMO Alphora Inc. was founded in 2003 and has a well-established history developing scalable API processes that meet the clinical and commercial requirements for the biotech and pharmaceutical industry and has been successfully approved by both the FDA and Health Canada. This experience differentiates the company by applying its rigorous API development expertise to produce well-characterized, synthetic phytocannabinoids and reference standards of high purity, which are not readily produced through traditional extraction involving cannabis plants or seeds.
With the increasing interest in the medical applications of phytocannabinoids, Eurofins CDMO Alphora Inc. is well positioned to leverage its pharmaceutical experience to support this growing and exciting market.
To learn more, please visit: www.eurofins.com/cdmo
About Eurofins CDMO:
Eurofins CDMO is a leading global Contract Development and Manufacturing Organization that provides clients with active pharmaceutical ingredients (“API’s”) / drug substance and drug product development for small molecules and biologics. Its service offering encompasses drug substance/API development, solid state research and development, pre-formulation, formulation and development, analytical development, GMP manufacturing and clinical packaging and logistics. Operating with facilities in Europe, North America and India, Eurofins CDMO is accredited through the FDA, EMA, ANSM, ANSES, FAMHP, PMDA, and Health Canada. Eurofins CDMO is part of the Eurofins Group.
Contacts
For further information:
Cheryl Young, HBSc.
VP Business Development & Project Management
Eurofins CDMO Alphora Inc.
Cheryl.Young@bpt.eurofinsca.com