Cannabinoids - API/DP Development & Manufacturing
API Services 
Eurofins CDMO Alphora Inc. announces receipt in April 2022 of its Health Canada Standard Processing License issued within the Cannabis Act and Cannabis Regulations for its Oakville, Ontario Operations. This is complementary to the institutional Research License through Health Canada in June 2021 for its Mississauga development site. We have developed scalable processes for several naturally occurring phytocannabinoids including CBD, CBDv, THC, THCv, and are preparing processes for others such as CBN, CBDA.
Differentiator:
We apply our rigorous API development expertise to produce well-characterized synthetic phytocannabinoids and reference standards of high purity, which is not readily achieved through traditional extraction involving cannabis plants or seeds.
- Synthetic routes & process development for phytocannabinoid molecules
- Manufacturing processes for highly pure phytocannabinoids
- Analytical development expertise for quality control
- Reference standards preparation
- cGMP compliant facility
- Project management
DP Services
Eurofins CDMO network of companies applies innovative formulation technologies for bioavailability enhancement and stability improvement of cannabinoids (CBD & THC), with patient compliant dosage forms (mini tablets, sublingual, buccal, gums) as ultimate goal. We have analytical expertise for related method development in-house and required controlled substances licenses available.
- Pre-formulation, formulation development
- Analytical method development
- Stability assessment (Accelerated stability study, ASPA, ICH stability)
- GMP manufacturing
- QC testing & QP release
- Controlled Substances GMP storage
- Clinical trial supply
- Scale-up & facility transfers
- Regulatory dossier writing (IMPD - IND - CTD)
