Health Canada Approves Eurofins CDMO Alphora Inc.’s Cannabis Drug License for Synthetic Phytocannabinoids
October 11 2023 - 7:46AM
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20231011911111/en/
For further information: Cheryl Young, HBSc. VP Business
Development & Project Management Eurofins CDMO Alphora Inc.
Cheryl.Young@bpt.eurofinsca.com
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