Xcelience has received approval from the Federal Drug Enforcement AdminIstration to develop and manufacture Schedule I controlled substances in their facilities. Schedule I substances are “considered the most dangerous class of drugs,” according to the DEA website. Xcelience has a long history of working with DEA controlled substances and this license extension completes their approval to now handle both analytical and manufacturing of the full spectrum of DEA Scheduled products. This new achievement solidifies Xcelience as the choice CDMO for all of your global clinical outsourcing needs, including all of your scheduled product requirements.
Clinicians continue to find potential therapeutic indications for Schedule I drug substances. “Regulatory capability is a critical attribute for CDMOs,” says Alex McClung, Vice President, Quality at Xcelience. “This Schedule I-V license underscores our capability and extends our Suite of Services to a whole new class of therapeutic compounds.” Being able to work on Schedule I controlled substances will enhance Xcelience’s research capabilities and expand the types of research programs the company can support. This news comes in addition to their announcement for expansion. Xcelience is expanding its pharmaceutical development services and manufacturing capacity by adding a new facility in the Tampa area to include more pharmaceutical development labs, manufacturing, quality assurance and packaging services.