STA Pharmaceutical Co., Ltd., a subsidiary of WuXi AppTec, 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. 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.
The Changzhou facility – which opened in early 2016 and is situated on a site of 39 acres – 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 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.
“We are very proud of successfully passing FDA inspection once more,” commented Ms. 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.”
About WuXi STA
STA Pharmaceutical Co., Ltd., a subsidiary of WuXi AppTec (WuXi STA), is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life science industry, with operations in China and the United States. As a premier Contract Development and Manufacturing Organization (CDMO), WuXi STA offers our worldwide partners efficient, flexible and high-quality solutions for Active Pharmaceutical Ingredients (APIs) and finished dosage forms. For more information, please visit: http://www.STApharma.com
About WuXi AppTec
WuXi AppTec is a leading global pharmaceutical and medical device open-access capability and technology platform company with global operations. As an innovation-driven and customer-focused company, WuXi AppTec provides a broad and integrated portfolio of services to help our worldwide customers and partners shorten the discovery and development time and lower the cost of drug and medical device R&D through cost-effective and efficient solutions. With its industry-leading capabilities such as small molecule R&D and manufacturing, cell therapy and gene therapy R&D and manufacturing, and medical device testing, WuXi platform is enabling nearly 3,000 innovative collaborators from more than 30 countries to bring innovative healthcare products to patients, and to fulfill WuXi’s dream that “every drug can be made and every disease can be treated.” Please visit: http://www.wuxiapptec.com
