Cedarburg Hauser's DEA Approval Brings Niche Manufacturing Home

The contract development and manufacturing organization’s (CDMO’s) facility in Denver, Colorado has been granted US Drug Enforcement Agency (DEA) approval to manufacture schedule II-V controlled substances, which, according to Cedarburg Hauser Pharmaceuticals, will widen the scope of manufacturing opportunities as it competes with overseas suppliers.

 “While foreign competition is certainly a very real challenge, pharmaceutical companies are turning to CDMOs in increasing numbers,”​ said Bob Forner, Marketing Manager at Cedarburg Hauser, speaking with Outsourcing-Pharma.com. He continued:

 “The rapidly growing industry leaves ample opportunity for domestic CDMOs to focus on niche fields such as such as targeted therapeutics, potent compounds and controlled substances.​

“These fields require special skill sets and/or greater regulatory oversight and expertise in these areas that helps build a competitive advantage over low-cost suppliers. This is exactly the approach Cedarburg Hauser has taken.”​

Currently Cedarburg Hauser can produce regulated substances such as opioids and steroids at its other facility in Wisconsin, yet a general increase in demand from customers had stretched capability at the site. The DEA license will relieve capacity and, according to Forner, allow the company to “serve both the new chemical entity and generic markets.”​

Manufacturing Moving Back West?​

Cedarburg Hauser’s approach has also seen the company recently expand its API manufacturing capacity at the Wisconsin site. The expansion​ which added potent and cytotoxic substances to client offerings was also driven by demand.

Speaking at the time, Forner indicated that a lot of Western drug companies were returning to US CMDOs following “varied experiences”​ with foreign low-cost manufacturers.

Regulatory tightening has played a part in the returning trend as it attempts to make the global supply chain safer by targeting riskier overseas facilities.

A new User Fee Bill​ passed last year led to compulsory inspections at both domestic and foreign manufacturing facilities by the US Food and Drug Administration (FDA), and the Generic Drug User Fee (GDUFA) was created, imposing fees on producers.

In another example of manufacturing returning to the US, Profectus BioSciences has ended a deal with European Boehringer Ingelheim to manufacture its DNA vaccines, choosing instead US CMO Althea Technologies. In this case, the volatile exchange rate between the Dollar and the Euro was given as a reason for the return. You can read the full story here​.