Controlled drugs must be approved by the FDA, but also require a manufacturer that has been vetted by the Drug Enforcement Agency (DEA). Contract manufacturer Cedarburg Hauser Pharmaceuticals had one plant approved and just snagged approval for a second.
The company says the DEA has approved its Denver, CO, plant to manufacture schedule II-V controlled substances, after it made upgrades to the plant and to plant procedures dictated by DEA requirements. "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.
The company said the approval adds to controlled substance manufacturing capacity already in place at its Grafton, WI, plant, which was already DEA certified. The company said last year it was expanding that plant by adding to its reactor capacity by nearly 50%. It also made improvements to its air-handling systems, installed a reverse osmosis water system, and improved isolation capabilities.
While the FDA approves the drugs, the DEA oversees aspects of their manufacturing and sets quotas on controlled substances. That practice has been controversial, particularly among parents of children with attention deficit hyperactivity disorder (ADHD). Some drugs for that condition, like Ritalin and Adderall, have been hard to come by at times, and often the finger has been pointed at the DEA for being stingy with quotas.
- here's the release
- read the earlier release