Japan’s Premier CDMO Will Invest $100m to Expand Capacity and Portfolio

Bushu Pharmaceuticals Ltd., one of Japan’s largest contract manufacturers of pharmaceutical products, announced on August 14 a major capital program costing $100 million to expand its footprint, capacity and portfolio of services. The program extends over the next five years in order to accommodate client needs.

Bushu Pharma is nearing completion of its 3,900-square-meter (42,000-sq.-ft.) cold chain warehouse facility at its Misato plant north of Tokyo. The new facility will be commissioned and validated by September of this year for storage of temperature-controlled sterile drugs and biologics for the Japanese market. The new facility is an important component in the company’s “Asia hub” strategy which enables international pharmaceutical companies to import bulk products into Japan for quality inspection, labeling, packaging and distribution throughout Japan and other Asian countries. The inspection capacity will be expanded to 12 stations for pre-filled syringes, and seven stations each for liquid vials and for lyophilized vials. Of the 26 inspection stations, 23 will be supported by cameras. This will establish Bushu Pharma as the leading provider of sterile drug inspection in Japan’s outsourced market. The Japanese market requires 100% visual inspection of pharmaceutical products intended for sale in Japan, which is particularly time-consuming and complex for sterile and biologic products.

In addition to the new warehouse and inspection capacity, Bushu Pharma has also funded the addition of eight new packaging lines, including one pre-filled packaging line and a new water-for-injection line to support its sterile manufacturing filling suite. Bushu is also upgrading its production automation systems and its laboratory information management system (LIMS) as part of a long-term IT master plan.

Bushu Pharma is now working with several multi-national pharmaceutical clients, which has also allowed the company to establish an international technical transfer team. This expanded team will facilitate the transfer of analytical methods and enable validation of foreign-made drugs into Bushu Pharma’s two manufacturing facilities.

“We are excited about our capital expansion plans,” said Tadao Takano, Bushu Pharma’s Chief Operating Officer. “Our Asia hub strategy is coming to life. The added space and additional inspection lines will allow us to bring more of our client’s bulk products into the country, which will make their logistics and supply chain systems much more efficient.”

Bushu Pharmaceuticals Ltd. was established in August 1998 as an independent pharmaceutical contract manufacturer. Bushu, capitalized at 1 billion yen, carries out contract manufacturing and packaging of clinical trials and commercial products in accordance with the latest GMP standards. Through the utilization of know-how and the latest industry information, Bushu Pharma prides itself in being able to offer added-value solutions to customers.