Oso Bio gets green light to handle controlled substances
Receives US Drug Enforcement Administration (DEA) approval
OSO BioPharmaceuticals Manufacturing, headquartered in Albuquerque, New Mexico, US, has been granted research and analytical licences by the US Drug Enforcement Administration (DEA) to handle Schedule II–V controlled substances.
OsoBio, an injectables contract manufacturing organisation (CMO), produces sterile liquid, suspended and lyophilised biologic and pharmaceutical products.
‘OsoBio is well suited to handle controlled substances,’ said Dr Stuart Rose, president and ceo.
‘As a highly disciplined organisation, OsoBio is comfortable with the processes, controls and documentation required when working with especially sensitive pharmaceutical materials. We do the work that's difficult to do.’
The DEA categorises controlled substances according to their use in medical treatment, as well as their potential for abuse or causing dependence.
‘There aren't many companies in the US capable of producing injectable controlled drugs, so we've already fielded a number of calls from clients who have that need,’ Rose added.