Production and Logistics (Demand Chain Systems)

Eisai believes the best way to contribute to the well being of patients is by providing them with a stable supply of high-quality pharmaceutical products. The company is therefore particularly fastidious about conducting the manufacturing process itself, and makes special effort in assuring the quality of its products, from the manufacturing stage all the way to their use by patients.

Eisai's General Policy on Product Quality states that, “Each tablet, capsule, ampoule that we manufacture relates directly to human life.” It ensures that while conducting their regular work operations, Eisai's employees remain keenly aware of how the company's products are tied directly to the life of patients.

Meanwhile, from January 2003, Eisai Inc. in the U.S. assumed responsibility for distributing its own products, thus completing a seamless chain from production through distribution. We will continue to make the necessary efforts to provide patients around the world with a stable supply of trustworthy pharmaceutical products of good quality.

• Global Manufacturing System
• Japanese Production Bases

Global Manufacturing System

All of Eisai's production bases are linked closely to enable them to provide a stable supply of global products. The bases include the Misato Plant, the Kawashima Plant and the Kashima Plant in Japan, the RTP Plant in North Carolina in the U.S., the Suzhou Plant in China, the Tainan Plant in Taiwan, and the Bogor Factory in Indonesia. While mutually exchanging knowledge with each other, personnel at all the bases strive to build efficient production systems supplying high-quality products.

Now two plants opened in England and India in order to maintain more stable supply of our products to new markets. The company has thus built a global structure for supplying products.

The production of pharmaceutical ingredients for the manufacturing of global products is carried out exclusively at the Kashima Plant. Pharmaceutical manufacturing is concentrated at the Misato and the Kawashima plants in Japan, and the RTP Plant in North Carolina, and the Suzhou Plant in China. Considering the need for flexibility in responding to the different languages and regulations of each region, as well as demands of each market, packaging is carried out as closely as possible to the target market.
For global products, meanwhile, a production system has been established for manufacturing at multiple production bases. For that purpose, production permits have been obtained to allow production at locations other than the company's regular production bases. This makes it possible to assure a stable supply of products at all times.

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Japanese Production Bases

The plant was officially approved for the manufacture of Pariet®/Aciphex® in 1997 by the Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K., and in 1998 by the U.S. Food and Drug Administration (FDA). Additionally, in 2004, it obtained FDA approval for the manufacture of Aricept® rapid disintegration (RPD) tablets.

With Environmental Management System (EMS) and Occupational Health and Safety Management System (OHSMS) certifications, obtained in 2000 and 2004 respectively, the Misato Plant is operating in a safe, secure, and environmentally friendly manner.

At the Kawashima Industrial Park, the company is manufacturing solid oral preparations as its main product. The Industrial Park includes the first production facility (completed in 1969), the second production facility (completed in 1975), the third production (formulation) facility (completed in 1986), and the fourth production (packaging) facility (completed in 1997). The production facilities are fully automated plants equipped with automatic conveyance systems, central monitoring/control systems, automatic measurement systems, and robotic arm packing systems. Taking advantage of a clinical development and research center within the plant, Kawashima Industrial Park has established an operational structure under which coherent R&D can be conducted, from development through later phases, including investigation of manufacturing methods and establishment of standards for new products.

The Kawashima Plant was approved as a site for manufacturing Aricept® for export to the U.S. by the FDA in 2004 and by MHRA in 2008. The facility now operates as a global-oriented production base.

The Kawashima Industrial Park obtained Environmental Management System (EMS) certification in 1999, and Occupational Health and Safety Management System (OHSMS) certification in 2003. Additionally, in 2006, it received Social and Environmental Green Evaluation System (SEGES) certification, in recognition of its activities as an industrial park.

In fact, the facility's main feature is that dual function, i.e. research into the commercialization of medicines and production of the ingredients used in pharmaceutical products. Making the best use of those two functions and utilizing the company's cumulative production technology and expertise, the production processes for pharmaceutical ingredients are studied from an early development stage on the grounds that they will be produced commercially. Also, by improving the manufacturing process, product quality is raised, stable supplies are provided, and environmental preservation is realized.
The pharmaceutical ingredients manufactured at the Kashima Plant are supplied not only to production bases in Japan but also to overseas production bases such as the one in North Carolina in the U.S.

In 2004, a pilot production building was added to the Kashima Plant to speed up R&D processes and increase its capacity for manufacturing pharmaceutical ingredients.
In 2006, the renovation of part of the building was finished to prepare for the production of ingredients for oncology products.

As the global production base of Eisai for manufacturing pharmaceutical ingredients, the Kashima Plant will continue to fulfill its mission of providing a stable supply of high-quality pharmaceutical ingredients.

The Kashima Plant, at which chemical reagents are stored and handled, obtained Environmental Management System (EMS) and Occupational Health and Safety Management System (OHSMS) certification in 1999 and 2003, respectively. The plant successfully engages in investigating safer and more environmentally friendly processes, and operates accordingly.

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