STA Pharmaceutical announces that its active pharmaceutical ingredient (API) R&D and manufacturing facility located in Changzhou, China has secured Pre-Approval Inspection (PAI) for two APIs from the U.S. Food and Drug Administration (FDA) – with no Form 483s issued. This is the first time that WuXi STA’s Changzhou facility has been inspected by the FDA.
WuXi STA has already passed several inspections from the FDA at its API and advanced intermediate manufacturing facility in Shanghai, Jinshan and at its drug product manufacturing facility in Shanghai, Waigaoqiao free trade zone. As a global leading Contract Development and Manufacturing Organization (CDMO), WuXi STA is the first CMC platform (including both APIs and drug product) in China to have passed FDA inspection for new chemical entities. It is also the first CDMO in China that is approved to supply APIs and GMP intermediates for branded commercial drugs by regulatory agencies in the USA, China, EU, Canada, Switzerland, Australia, and New Zealand.
Currently, the facility employs more than 1000 people including 200 scientists, and has three plants in operation. However, the company will continue to add more than 300 scientists and seven multi-functional plants within the next five years. As a purpose-built facility, Changzhou offers an integrated one-site solution for partners to accelerate innovative APIs and advanced intermediates – from preclinical and clinical development through to global commercial launch.
“Quality is ingrained throughout our culture here at WuXi STA and one of our core competencies. The Changzhou facility passing its first FDA inspection, with no observations – or even written or verbal recommendations – is yet further proof of our commitment to the highest possible quality standards. It’s a point of great pride that we have an exemplary regulatory record, and evidence of the company’s ability to supply the U.S. market with innovative commercial APIs from the Changzhou site.” said Dr. Minzhang Chen, CEO of WuXi STA.