Having had their dalliances with foreign API manufacturers, U.S. drugmakers may be ready to spend more of their money at home.
That is what officials with Wisconsin-based Cedarburg Hauser are anticipating as they prepare for further expansion of their API plant, and they have the FDA to thank for that.
"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 5 years," Bob Forner told Outsourcing-Pharma, as reported by in-PharmaTechnologist. "We expect this to have a positive impact on our generic API business."
The API maker recently added a 500-gallon reactor, a Teflon-lined reactor and a low-temperature chiller so that it can handle cryogenic reactions. Forner tells FiercePharmaManufacturing in an email, the new reactors added 2,000 liters of capacity to the plant. He decline to say what the cost of the investment was.
The plant has been making steroids, prostaglandins, vitamin D analogs and compounds that are conjugated to polymers or peptides, but has gotten requests to work with cytotoxic and potent oncology drugs. The new equipment will allow that.
The company has filed with the FDA drug master files (DMFs) for a schedule II opioid, fentanyl, two steroids, exemestane and oxandralone, among other compounds, Forner tells the publication. "We are also manufacturing a number of APIs at various clinical stages," he said.
Forner said in his email that with its expansion, the company expects to add 15 to 20 employees over the next 12 months.
Problems with foreign API makers have been well-publicized and domestic makers are anxious to see foreign manufacturers be visited by FDA inspectors at least as often as they are. The program, while getting started, will be a little slow taking off since Congress has yet to give the agency the authority to actually collect the fees from generic drugmakers that are supposed to pay for the expanded foreign inspections.
- here's the company's release
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