The factory, in Wisconsin, US, now houses a 100l Teflon reactor and a low-temperature chiller allowing it to perform cryogenic reactions. The expansion also includes a 500 gallon reactor, a reverse osmosis water system and an upgrade for its digital automation system.
Spokesman Bob Forner told Outsourcing-Pharma.com: “The 500 gallon reactor significantly increases our capacity and gives us flexibility in our manufacturing plant. The 100L Teflon lined reactor and low-temperature chiller allow us to run reactions at -80°c, and also allows for corrosive reactions not able to be run in glass or metal.”
He said the plant – which currently makes steroids, prostaglandins, vitamin D analogs and compounds that are conjugated to polymers or peptides – will now work with potent and cytotoxic compounds. The target clients will be pharma firms throughout the product lifecycle, from clinical trials through to generics.
“More specifically, we have filed drug master files (DMFs) with the FDA for a schedule II opioid, fentanyl, two steroids, exemestane and oxandralone, and a prostaglandin, travoprost, among other compounds. We are also manufacturing a number of APIs at various clinical stages,” Forner added.
Cedarburg said the move was a result of increased demand for contract API manufacturing services.
Forner told us the recent “boom” of cytotoxic and potent oncology drugs is one of the biggest reasons for the uptick.
He also told us many Western manufacturers are heading home for their ingredients after a “varied experience” with international low-cost manufacturers. And with new US Food and Drug Administration legislation over foreign inspection, the company believes this trend is on the rise.
“New provisions in Prescription Drug User Fee Act (PDUFA) 5 allowing the FDA to collect user fees for generic drugs will also require the FDA to inspect foreign manufacturing facilities every two years rather than every five years,” he said. “We expect this to have a positive impact on our generic API business.”
According to CEO Tony Laughrey, this expansion will not be the first in the near future. He said: “We will continue to invest in our business as we strive to be the premier contract API manufacturer.”
Forner told us however that growing the product portfolio and increasing staffing levels will be the most immediate developments.
“Over the next year Cedarburg Hauser will look to build our business with a product portfolio of generic and new chemical entity products,” he said. “We also have plans to continue expansion through capital expenditure, as well as 15 to 20 operators, engineers and scientists over the next 12 months.”