
2003-01-23
Large
0 Inquired
0 Favorited
ConnectService Type:
T - Technology and Patent Services
Industry:
Pharmaceuticals and Chemical IntermediatesFine Chemical ManufacturingChemical Engineering Technology Research and Development and Process Package
Country / Region:
China
Company Type:
Wholly Foreign-Owned EnterpriseSpecialized Sophisticated and Novel Enterprises
Registered Capital:
RMB 531.338441 million
corporate capability: Overseas Chemical Services、Full-Cycle Chemical Project Services、Chemical Technology & Patents、Process Technology Development、Technology Transfer、Process Package Design、Plant Startup、On-Site Engineer Staffing、On-Site Expert Support
Shanghai SynTheAll Pharmaceutical Co.,Ltd. is a wholly owned subsidiary of WuXi AppTec Group, specializing in end-to-end research and development (R&D) and manufacturing services (CDMO) for small-molecule drugs and complex active pharmaceutical ingredients (APIs), advanced intermediates, and drug products for global pharmaceutical clients. Its service scope covers the entire lifecycle—from preclinical stages to commercialization—and it ranks among the industry leaders in China’s CDMO sector. The company’s core business activities include process R&D, analytical method development, quality research, GMP manufacturing (including specialized categories such as highly potent, highly sensitizing, and challenging chiral compounds), aseptic injectable development and fill-finish, and industrial-scale application of continuous flow technology. Its core competencies encompass continuous manufacturing (with multiple multi-ton-scale continuous flow production lines established), enzymatic catalysis and biotransformation, closed-system manufacturing of highly potent APIs (HPAPIs), solid-state chemistry and polymorph control, and Quality-by-Design (QbD)-driven process development systems. As of the end of 2024, the company had filed over 1,200 patent applications, more than 85% of which were invention patents. All its major production sites hold GMP certificates issued by China’s NMPA, the U.S. FDA, the European Union’s EDQM, Japan’s PMDA, and South Korea’s MFDS. Its Changzhou site is the first CDMO API commercial manufacturing facility in China to have passed an FDA cGMP on-site inspection; its Wuxi site has obtained an EDQM GMP certificate; and its Ningbo site commenced operations in 2024 and simultaneously passed the NMPA’s GMP compliance inspection. The company serves over 800 global clients, including more than 40 of the world’s top 20 pharmaceutical companies. Representative projects include supplying key intermediates for Merck’s Keytruda®, APIs for Gilead’s Biktarvy®, integrated services for Hengrui’s SHR-1701, and global supply chain support for BeiGene’s zanubrutinib. Its business spans North America, Europe, Japan, South Korea, and Southeast Asia, with overseas revenue consistently accounting for over 65% of total revenue. It offers full-process collaboration—from early-stage R&D to commercial supply—for innovative drug developers, generic drug manufacturers, and multinational pharmaceutical enterprises.
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