Sumitomo Pharmaceutical Manufacturing Plant, Ibaraki, Japan

Sumitomo Pharmaceutical Company (now known as Dainippon Sumitomo Pharma) completed the construction of its manufacturing plant in Ibaraki city, near Osaka in Japan in 2000. At this time the company also began the construction of a new building for the manufacture of injectable pharmaceuticals at its established Ehime Bio plant (Niihama, Ehime Prefecture). The new building at Niihama was completed in 2002.

MERGER AND ACQUISITION

The new entity Dainippon Sumitomo Pharma was formed in October 2005 through the merger of Dainippon Pharmaceuticals and Sumitomo Pharmaceutical. The new company will focus on its four main products: Amlodin (for hypertension and angina pectoris), Gasmotin (gastroprokinetic agent), Prorenal (for the improvement of peripheral circulation), and Meropen (carbapenem antibiotic).

The new merged company also has an excellent drug pipeline for the treatment of conditions in areas such as central nervous system disorders (CNS), diabetes, allergies, inflammatory and bone diseases, and cancer and infectious diseases. The merged company has manufacturing capacity but will probably make a lot of revenue through licensing various drugs out for manufacture and marketing by other companies.

PHARMACEUTICAL SOLID PREPARATIONS

The two projects were meant to enhance the manufacturing capacity of the company for the production of pharmaceutical solid preparations. The new facilities have helped the company to manufacture the volume required for the growing sales of Amlodim tablets, an important drug for hypertension and angina pectoris, and Sediel tablets, an anti-anxiety seratonin inhibitor.

The Japanese pharmaceutical industry has been confronted with difficulties, in particular a drastic reform of the medical insurance system including an overall review of the drug tariffs system. Sumitomo Pharmaceuticals' management is determined to react to these difficulties by further strengthening its business foundations. The strategy is to promote its strategic and efficient business operations, building up a corporate system for speedier discovery and development of new drugs as well as for continuous acquisition of regulatory approval and release to the market.

The new facilities are also intended to fill the requirements for new products to be launched in the future (also to produce clinical trial quantities of drugs for evaluation). This is essential to the company's profitability in the severe Japanese pharmaceutical business environment.

BIO PLANT FACILITY

The company started the construction of the Ibaraki manufacturing facility in 1999. The site was completed in July 2000. The Ehime Bio plant facility construction started in 2000. The building was scheduled to be completed by 2001 but actually took until early 2002 to complete.

IBARAKI PLANT

The newly constructed facility is a six-storey reinforced concrete building (with one section being seven storeys) and covers an area of about 1,400m². The first floor has been set up independently for the manufacture of parenterals (injectable drugs), while the second and upper floors were designed for the manufacture of solid preparations. The total floor space is approximately 8,500m².

The manufacturing facilities for parenterals for clinical tests were designed to meet GMP (good manufacturing practice) standards, taking the future globalisation of R&D activities into consideration. The construction was also planned in order to fulfil the legal requirements for acquiring the international standard for excellent environmental management system which has brought the company to the acquisition of the ISO 14001 certificate.

The cost for the plant (building only) was in the range of $9.9m.

EHIME BIO PLANT

The Ehime Bio Plant new building was designed for the manufacture of new parenteral phamaceuticals and other sterile preparations together with Amlodim and Sediel production.

The new building is a two-storey, reinforced concrete structure with a building area of approximately 2,700m². The ground floor accommodates a manufacturing area and combined office/warehouse space, while the first floor houses the air conditioning plant room and other services.

The Ehime bio plant has a total floor area of approximately 18,890m², as compared with approximately 15,400m².

Since it opened, the Ehime Bio Plant has concentrated on the manufacture of the intermediate solution of Sumitomo's natural alpha-interferon product Sumiferon by a cell culture process. The aseptic techniques used in this process have been applied to the promising field of sterile preparations, and the company plans to make the Ehime Bio Plant the focus of its manufacturing efforts in this field.

The investment in the new building was approximately $18.1m.

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