STA Pharmaceutical Co Ltd – a subsidiary of WuXi AppTec – announced that its Jinshan manufacturing facility in Shanghai, China has successfully passed an inspection by the European Medicines Agency (EMA) with no critical and no major findings. This demonstrates that as the trusted partner of global customers, WuXi STA can provide high quality GMP manufacturing services in compliance with global regulatory standards, to enable customers accelerate the development and manufacturing of new medicines for patients around the world.
“It’s the first time that our Jinshan facility is audited by the EMA, with five auditors conducting a five-day inspection, spanning 11 products approved by the EMA in recent years. We continue to keep up a state of perpetual readiness across all our sites and actively welcome global regulators or client audits at any time. This is a direct testament to our organization’s culture of quality first, and real-time GMP monitoring.” commented Ms. Mei Hao, Vice President of Quality at WuXi STA.
This quality inspection approval marks a significant year for WuXi STA in exceeding global regulatory standards. In March, the company’s new drug product manufacturing facility in Shanghai Waigaoqiao passed its GMP inspection by the European Medical Products Agency (MPA), and in June, its Jinshan manufacturing facility passed a Pre-Approval Inspection (PAI) by Japan’s Pharmaceutical and Medical Device Agency (PMDA) for an innovative drug. Further, in July, WuXi STA’s Analytical Service Unit (ASU) in Shanghai and active pharmaceutical ingredient (API) process R&D and manufacturing facility in Changzhou passed two inspections by the U.S. Food and Drug Administration (FDA) within the same week, with no Form 483s issued.
“The successful EMA inspection at Jinshan is yet further proof of WuXi STA’s commitment to enforcing the highest global quality systems. We will continue to pursue a ‘quality first’ commitment, constantly enhancing our platform with new services to enable our customers to bring better medicines to patients faster,” noted Dr. Minzhang Chen, CEO of WuXi STA.
WuXi STA has been engaged in new drug development and manufacturing for more than a decade, offering global partners efficient, flexible and high-quality solutions from preclinical to commercial uses with the integrated CMC (Chemical, Manufacturing, and Control) platform. More recently, WuXi STA expanded its platform to support oligonucleotides and peptides. The company has started construction of a new API process R&D center next to the current Jinshan site, adding 30,000 square meters of laboratories and more than 800 scientists. After completion, the Jinshan facility will become the second integrated site after Changzhou to support process R&D and manufacturing of innovative APIs for global partners. This year WuXi STA also initiated the third phase construction of a Changzhou API process development and manufacturing facility, which covers an additional 35 acres.
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 integrated CMC (Chemical, Manufacturing, and Control) solutions from preclinical to commercial uses. For more information, please visit: http://www.STApharma.com
About WuXi AppTec
WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. As an innovation-driven and customer-focused company, WuXi AppTec helps our partners improve the productivity of advancing healthcare products through cost-effective and efficient solutions. With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec’s open-access platform is enabling more than 3,600 collaborators from over 30 countries to improve the health of those in need – and to fulfill our dream that “every drug can be made and every disease can be treated.”