Cedarburg Hauser Pharmaceuticals (CHP), a contract development and manufacturing organization (CDMO), announced today that its Denver, Colorado facility has been granted registration as a manufacturer of schedule II-V controlled substances by the U.S Drug Enforcement Agency (DEA).
The new DEA registration status is the result of a concerted effort to enhance infrastructure and adopt procedural controls that facilitate compliance with DEA requirements. The ability to manufacture controlled substances affords the company additional capacity when added to the pre-existing controlled substance manufacturing capabilities at its Grafton, Wisconsin facility.
"The GMP manufacturing and analytical method development expertise of Cedarburg Hauser's Denver facility may now be extended to DEA scheduled compounds," says Vice President and General Manager, Joe Guiles. "This further emphasizes these competencies, and represents an opportunity to expand our customer base and serve the needs of our existing customers."
"The development and manufacturing of controlled substances requires stringent controls and security measures," added Dan Childers, VP of Quality Assurance and Regulatory Compliance. "DEA registration further illustrates the strength of the manufacturing, handling and storage controls in place at Cedarburg Hauser's Denver facility."
The registration is filed under InB: Hauser Pharmaceutical Services, and allows for the immediate manufacture of schedule II-V compounds.