Wisconsin CMO Cedarburg Hauser is expanding its API-production capabilities, responding to what it says is booming demand for drug components around the world.
The company is adding technology to allow for cryogenic reactions in its Grafton, WI, facility, and the project will increase its API-producing capacity about 50%, according to a statement. In addition to the new reactors, Cedarburg Hauser has updated the air and water systems at the plant and improved its isolation capabilities.
"The added reactor capacity and upgrades to existing safety and GMP systems are the latest example of Cedarburg Hauser's continued commitment to serving the commercial API marketplace," CEO Tony Laughrey said in a statement. "The flexibility afforded by the additional reactor capacity allows us to better meet our customer's on-time and on-budget requirements."
The increased demand for domestic API production is due in part to the FDA, Cedarburg Hauser said. The latest Prescription Drug User Fee Act requires the agency to inspect foreign manufacturers every two years instead of every 5, FiercePharmaManufacturing notes, and the company says that will likely drive pharma clients away from overseas API makers and back to American manufacturers.
And if that happens, Cedarburg Hauser plans to be ready. In addition to the expanded API plant, the company plans to boost its product portfolio and grow its staff of engineers and scientists over the next year, Outsourcing-Pharma reports.
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