Oso BioPharmaceuticals Receives DEA Approval to Handle Controlled Substances
Albuquerque, NM Jun 22, 2011 – OSO BioPharmaceuticals Manufacturing, LLC, has been granted approval for the Researcher registration by the U.S. Drug Enforcement Administration (DEA) for Schedule II through V controlled substances.
OsoBio, an injectables CMO, manufactures sterile liquid, suspended and lyophilized biologic and pharmaceutical products for the pharmaceutical industry. The new DEA registration allows OsoBio to execute the development of manufacturing processes for controlled substances.
Renowned for its expertise in difficult-to-manufacture, demanding or highly potent products, OsoBio is well suited to handle controlled substances, said Dr. Stuart Rose, president and CEO.
“As a highly disciplined organization, OsoBio is comfortable with the processes, controls and documentation required when working with especially sensitive pharmaceutical materials,” he said. “We do the work that’s difficult to do.”
The DEA places strict guidelines on the research, manufacture and distribution of controlled substances to prevent their diversion into illicit markets. The agency categorizes controlled substances according to each one’s respective use in medical treatment, as well as its potential for abuse or causing dependence.
The agency approved OsoBio’s registration application to conduct research related to the potential manufacture of Schedule II through V controlled substances for clients.
“There aren’t many companies in the United States capable of producing injectable controlled drugs, so we’ve already fielded a number of calls from clients who have that need,” Rose said. “As we broaden OsoBio’s capabilities in handling products that demand special attention, we demonstrate our continued confidence that our company will exceed quality assurance and regulatory compliance expectations.”