上海润栖医药科技有限公司

Shanghai Runxi Pharmaceutical Technology Co., Ltd., located in the Shanghai Zhangjiang Hi-Tech Bio and Pharmaceutical Innovation Incubation Park, is a comprehensive, technology-centered, and innovation-driven pharmaceutical and biotechnology company. As a customer-focused enterprise where quality is paramount, Runxi Pharmaceutical provides global biopharmaceutical companies with comprehensive one-stop services covering the entire process of bringing new drugs and generic drugs to market, including laboratory R&D, research and production, process scale-up, technology transfer, and regulatory registration. Through cost-effective and efficient services, the company helps clients shorten the R&D cycles and reduce the costs of new and generic drugs.

The company currently operates two R&D centers in Shanghai. One is a 1,000-square-meter chemical R&D experimental center equipped with first-class instruments and facilities. Its R&D team consists of over 20 members, including several experienced overseas-returned Ph.D. holders, graduates from the Shanghai Institute of Organic Chemistry of the Chinese Academy of Sciences, and management professionals with years of experience in the pharmaceutical industry. The other is a 2,000-square-meter biocatalysis R&D center, staffed by a technological innovation team of more than 50 people. Through the application of biocatalysis technology, the company has successfully addressed the scale-up and high-purity challenges of many novel chiral compounds while significantly reducing waste generation. Corresponding production bases have been established: the Shanghai Jinshan Plant covers 25 acres and includes a multifunctional pilot-scale workshop and a fully equipped large-scale production workshop capable of producing hundreds of kilograms to ton-level quantities. The Anhui Bengbu Plant spans 50 acres and is equipped with a full set of fermentation tanks, enabling an annual production capacity of 500 metric tons of biocatalysts and the conversion of 120 metric tons of intermediates and active pharmaceutical ingredients (APIs). Depending on client requirements, the company also collaborates with GMP and FDA-approved factories to produce corresponding APIs, advanced intermediates, and formulations. Some products have already obtained COS, EDMF, and DMF documents or certifications. These facilities collectively cover nearly all types of reaction conditions and containers, which can be selected based on project and client needs. Since its establishment, the company has adhered to a people-oriented and technology innovation philosophy, continuously developing and producing highly active and challenging novel pharmaceutical intermediates, extracts, amino acids, and APIs through innovative methods. Through close collaboration with the National Traditional Chinese Medicine R&D Center, the company has addressed pilot-scale challenges in plant extraction and traditional Chinese medicine R&D in China and has established corresponding pilot-scale GMP workshops. The company places great emphasis on intellectual property protection, continuously inventing and innovating R&D and production processes, applying for patents, and navigating patent and IP issues in regulated markets. Through comprehensive process and impurity studies, it provides clients with complete CMC and DMF registration documents, assisting them in completing the registration and approval of APIs and formulations in regulated markets.

After years of development and integration, Runxi Pharmaceutical will continue to expand and broaden its service areas, increase investment in technological and talent innovation, enhance its management and operational capabilities, and contribute to the continuous advancement of the global environment, human health, and quality of life.