Impax Transferring Products To Taiwan After GMP Warning Letter For U.S. Plant
This article was originally published in The Pink Sheet Daily
Future applications involving the Hayward, Calif. plant targeted by warning letter on manufacturing practices may be stalled, but Phase III Parkinson's candidate IPX066 won't be affected, execs say.
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Since Impax Laboratories’ CEO Wilkinson took the helm in April, the company has completed several significant deals and most recently restructured R&D to deliver savings, but a successful turnaround will require resolving outstanding manufacturing issues.
FDA dealt Impax Pharmaceuticals a “complete response” for its extended-release carbidopa/levodopa therapy for spasms suffered by Parkinson’s disease patients, rejecting the drug combo based on unresolved manufacturing issues at the firm’s Hayward, Calif., plant, though Impax has said it will manufacture the product, now called Rytary, exclusively at its Taiwan facility.
In recent warning letters, FDA continued to hammer manufacturers for inadequate investigation of out-of-specification results and lax oversight of manufacturing operations by quality control units.