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Sumitomo Chemical to build new API production plant in Japan

| By Mary Bailey

Sumitomo Chemical Co. (Tokyo, Japan) will construct a new manufacturing plant for active pharmaceutical ingredients (APIs) and intermediates for small molecule drugs at its Oita Works (Oita City, Oita Prefecture, Japan). This project is to enhance the company’s capacity to supply a variety of high-quality APIs and intermediates in response to the increasing demand for small molecule drugs. The new plant is scheduled to come on stream in September 2024.

Pharmaceuticals with low molecular weight, called small molecule drugs, are produced by chemical synthesis.  Leveraging the strengths in advanced organic synthesis technology and process engineering it has refined as a diversified chemical company, Sumitomo Chemical engages in the contract manufacturing of small molecule drug APIs and intermediates for pharmaceutical companies in its Contract Development and Manufacturing Organization (“CDMO”) business and also produces and supplies APIs by using its proprietary manufacturing processes. The global CDMO market, which is currently valued at approximately 10 trillion yen*2, is expected to continue growing steadily driven by robust demand due to an increase in new drug development programs. Over the years, the Company has been strengthening its CDMO business, and has established a leading position in Japan, building on its outstanding quality assurance system and global supply chain management.

The new plant at Oita Works can manufacture a wide variety of APIs and intermediates that require complex chemical reactions and also flexibly scale from development to commercialization, meeting the extensive needs of pharmaceutical companies. In addition, the plant is compliant with the US, EU and Japanese GMP, regulatory standards for pharmaceutical manufacturing and quality management, enabling the supply of high-quality products globally. The Company currently produces small molecule drug APIs and intermediates mainly at its Gifu Plant (Anpachi-Cho, Gifu Prefecture, Japan) and Okayama Plant (Kurashiki City, Okayama Prefecture, Japan). By adding the new plant at Oita Works as its third production site, the Company aims to enhance its supply capacity as well as reinforce its business continuity plan (BCP). At Oita Works, meanwhile, the construction of a manufacturing plant for drug substances for nucleic acid drugs, which are classified as middle molecule drugs, was started in October 2021. Furthermore, the manufacturing facilities of Sumitomo Dainippon Pharma Co., Ltd.*4, a subsidiary of Sumitomo Chemical, are also located in Oita Works. The Company will continue to enhance Oita Works as the core manufacturing site for the Sumitomo Chemical Group’s life science operations.