WuXi AppTec’s STA Subsidiary Passed Third U.S. FDA Inspection
Aug 15, 2016
SHANGHAI, August 15, 2016 -- WuXi AppTec Co. Ltd. (WuXi), a leading open-access R&D capability and technology platform company serving the pharmaceutical, biotechnology, and medical device industries, today announced that the small molecule active pharmaceutical ingredient (API) and advanced intermediate manufacturing facility located in Jinshan Shanghai, which is part of its subsidiary Shanghai SynTheAll Pharmaceutical Co., Ltd. (STA), recently successfully passed a general GMP and Pre-Approval Inspection from the U.S. Food and Drug Administration with no Form 483s issued. This is the third time that STA’s Jinshan facility passed the U.S. FDA inspection.
As a world-leading Contract Development and Manufacturing Organization (CDMO), STA has received multiple approvals to supply APIs and GMP intermediates for branded commercial drugs from regulatory agencies in the United States, Canada, the European Union, Switzerland, China, Japan, Australia, and New Zealand.
“Passing the third U.S. FDA inspection with no observations once again demonstrated our commitment and ability to provide the highest quality services to global life science community,” said Dr. Minzhang Chen, CEO of STA.
“I’m very pleased about STA’s continued track record in securing FDA inspection approvals,” said Dr. Ge Li, Chairman and CEO of WuXi AppTec, “it further confirms our reliability and credibility towards our business partners as well as the millions of patients that we proudly serve together.”
About WuXi AppTec
WuXi AppTec is a leading global pharmaceutical, biopharmaceutical, 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 in small molecule R&D and manufacturing, biologics R&D and manufacturing, cell therapy and gene therapy R&D and manufacturing, medical device testing, and molecular testing and genomics, WuXi platform is enabling more than 2,000 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
Shanghai SynTheAll Pharmaceutical Co., Ltd. (STA), a WuXi AppTec company, is a leading small molecule process 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), STA offers our worldwide partners efficient, flexible and high-quality solutions for small molecule Active Pharmaceutical Ingredients (APIs) and advanced intermediates from preclinical to commercial. For more information, please visit http://www.STApharma.com
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Director of Corporate Communications