CDMO Particle Sciences is now registered with the US Drug Enforcement Administration (DEA) as a manufacturer of Schedule I substances, which means that the company can now provide development and manufacturing services for pharmaceutical cannabinoid products.
The company points out that it has long been developing and manufacturing Schedule II-V drugs, including intranasal diazepam, specifically the formulation for Neurelis’s Valtoco nasal spray. Neurelis submitted an NDA for Valtoco in September 2018.
Particle Sciences President Robert Lee said, “Particle Sciences has built a solid reputation and specialized expertise in controlled substances as a result of our team’s work in complex formulations with substances in Schedules II – V. A high level of ethical standards and water-tight controls/processes including accurate documentation are essential to carry out controlled substances work and these are already firmly ingrained in our day-to-day operations.”
General Manager Barbara Morgan commented, “The Schedule I registration will open up opportunities for us to work with clients with appropriate sources of controlled substances to further investigate the therapeutic value and effects of these compounds and help shape this emerging area of medicine.”
Read the Particle Sciences press release.
