Vici Health Sciences, a customer-focused pharmaceutical CDMO that offers formulation development services, R&D program management, FDA regulatory support, phase 1 and phase 2 cGMP clinical batch manufacturing has added DEA scheduled 1-5 controlled substances import and export capability.
The expansion in capability was made to support sponsors with clinical development needs for both NDA and ANDA projects. There is a critical need and increased interest in developing alternatives to currently available mental health and CNS medicines, which often underperform for patients and their healthcare providers. Systematic controlled clinical studies performed by highly reputed pharmaceutical companies and drug development scientists have recently revealed that psychedelic DEA schedule I molecules can show great promise for the treatment of PTSD, depression, migraine, dementia, and other difficult-to-cure CNS conditions. In addition, there is a great focus on developing alternatives to highly addictive opioid analgesics that are prescribed for post-operative and chronic pain leading to significant damage to communities in the US and globally.
Vici can develop novel formulations and active pharmaceutical ingredients, manufacture clinical supplies, and support sponsors with clinical studies that are often performed internationally for quicker and better outcomes in a cost-efficient manner. With the newly acquired import and export license, Vici can now support clients with pre-clinical and clinical development for all DEA-scheduled molecules.