STA Pharmaceutical (WuXi STA), a subsidiary of WuXi AppTec has announced that its active pharmaceutical ingredient (API) R&D and manufacturing facility in Changzhou, China, has passed its first inspection by the US Food and Drug Administration (FDA).
Inspection
The facility secured pre-approval inspection (PAI) for two APIs from the regulatory agency without issuance of a Form 483.
Other WuXi STA facilities have passed FDA inspections, including its Shanghai, Jinshan API and advanced intermediate manufacturing facility and its Shanghai, Waigaoqiao free trade zone drug product manufacturing facility.
“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.
“We are very proud of successfully passing FDA inspection once more,” commented Mei Hao, vice president of Quality at WuXi STA, “we will continue to strengthen our global quality systems to meet and surpass even the most stringent regulatory requirements. This ensures we provide the highest standard of quality services to our partners worldwide.”