CMO PCI Synthesis recently completed its sixth US FDA inspection at its cGMP site in Newburyport, Massachusetts.
The multi-week inspection at the 70,000-square-foot facility covered a general cGMP compliance review as well as pre-approval inspections (PAIs) for two APIs (active pharmaceutical ingredients) filed by two different clients earlier this year. PCI now has a total of eight products that have been successfully pre-approved and/or commercialized to date.
“The recent inspection went well and we got some kudos for our team from the FDA who said we did a good job,” Edward Price, president of PCI Synthesis, told Outsourcing-Pharma.com. The pre-approval status means the company’s clients’ ANDAs (abbreviated new drug applications) will be approved shortly, Price added.
Over the past two years, PCI has launched more than five APIs for the generic market with exclusive supply agreements – bringing its total to 17 exclusive APIs in its overall pipeline.
But the recent success for PCI comes as the company has struggled with FDA inspections in the past. In 2010, the site was hit with a warning letter from the FDA, though the agency later closed out the violations that were initially cited in the letter.
Price said the last time the FDA inspected the site was to close out the warning letter. He also noted that the agency has raised its standards for inspecting API plants in the northeast region as the company was inspected in previous years “but never had any issues.”
In addition to being a CMO, Price said the company has weathered the lows of outsourced manufacturing through its pipeline of commercial APIs and, though mostly it’s manufacturing APIs for generic companies.
In addition to the Newburyport plant, the company also has a 10,000 square foot R&D facility in Devens, Massachusetts and employs 98 people, Price said.