SHANGHAI, March 27, 2019 – STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – announces that its new drug product manufacturing facility in Shanghai Pilot Free Trade Zone has passed its first GMP inspection by the European Medical Products Agency (MPA). The new facility was opened at the end of 2018, and the successful inspection demonstrates the outstanding quality control system and rapid development of WuXi STA’s drug product services.
In 2017, WuXi STA merged with WuXi AppTec’s Pharmaceutical Development Services unit, realizing a seamless integration of chemistry, manufacturing and control (CMC) services. Two new commercial drug product facilities – in Shanghai and Wuxi City – have come into operation, enabling WuXi STA to support solid dosage drug development from preclinical to commercial stages, with several phase III and commercial drug product projects underway.
WuXi STA has received FDA inspections at both its API manufacturing facility in Jinshan (Shanghai) and API R&D & manufacturing facility in Changzhou. As a leading global Contract Development and Manufacturing Organization (CDMO), WuXi STA has passed inspections by regulatory bodies in the U.S., Canada, EU, Switzerland, China, Australia and New Zealand to supply APIs and GMP advanced intermediates for partners.
“We are very proud to have passed the European MPA GMP inspection,” commented Ms. Mei Hao, Vice President of Quality at WuXi STA. “We will continue to strengthen our global quality control system to meet the most stringent regulatory requirements and ensure the quality of services to our partners worldwide. It is a key milestone in our efforts to build geographically integrated capabilities for both drug product and substance development and manufacturing.”
“Quality is not just a core competency, it is ingrained throughout our culture at WuXi STA. The new facility passing the MPA’s GMP inspection is a proof of our commitment to the highest possible quality standards. We look forward to empowering more customers to develop innovative drugs faster and more efficiently for the benefit of patients around the world,” said Dr. Minzhang Chen, CEO of WuXi STA.
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 sciences 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 more than 3,500 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