STA Pharmaceutical (WuXi STA), a subsidiary of WuXi AppTec, said 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 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 U.S., China, EU, Canada, Switzerland, Australia, and New Zealand.

The Changzhou facility, which opened in early 2016 and sits on a 39-acre site, has been designed to keep pace with the increasing demand WuXi STA is seeing from customers, as more products move into commercial production.

Currently, the facility employs more than 1,000 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,” said Dr. Minzhang Chen, chief executive officer, WuXi STA. “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.”

Ms. Mei Hao, vice president of quality, WuXi STA, said, “We are very proud of successfully passing FDA inspection once more. 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.”