US FDA gives green light for WuXi intermediate manufacturing
The regulatory body “found no issues requiring a Form 483” at a facility in Jinshan, near Shanghai, belonging to WuXi's wholly owned subsidiary Shanghai SynTheAll Pharmaceutical Company (STA), according to Director of Investor Relations Ron Aldridge.
Aldridge told Outsourcing-pharma.com the inspection was necessary as the facility is “now manufacturing an intermediate that required regulatory review” though, due to client confidentially, he was unable to divulge either the client or the product.
“The commercial products we have manufactured to date have been advanced intermediates that did not require FDA inspection,” he said, adding the site - which has been commercial manufacturing small molecule APIs and advanced intermediates since 2010 - would be boosted by this regulatory thumbs up.
On top of ingredients for marketed products, the facility produces study materials for preclinical and clinical trial. All are intended for the global market, Aldridge said, with STA’s customers being mainly multinational pharmaceutical companies.
WuXi has not been involved in any quality or regulatory issues, according to Aldridge, and the site in Jinshan is cGMP quality.
“This FDA inspection shows that we meet the highest regulatory standards,” he said. “The uptake from U.S. and European customers has been very strong, as evidenced in the seven-fold increase in our manufacturing revenues between 2009 and 2013.
“We expect continued strong growth in manufacturing revenue as a result of the strong pipeline of projects and large customer base we have built.”
