-Establishment of New Business Alliance and Facility to Provide Comprehensive Support for New Product Launches for Manufacturers Aiming to Enter Japan Market-

Bushu Pharmaceuticals Ltd. (hereinafter “Bushu Pharma”) has entered into a business alliance agreement with Suzuken Co., Ltd. (hereinafter “Suzuken”) to offer a service that provides comprehensive support for new product launches for specialty pharmaceutical manufacturers looking to enter the Japanese market.

In recent years, the number of innovative specialty pharmaceuticals on the market, such as biopharmaceuticals, regenerative medicines, and orphan drugs for rare diseases, that require strict temperature, inventory, and security control has been increasing. In line with this trend, the number of pharmaceutical manufacturers aiming to introduce these types of products to Japan has been increasing as well. These pharmaceutical manufacturers, however, frequently do not have the required assets such as manufacturing plants, distribution centers and networks necessary to enter the Japanese market with minimal resources and, therefore, must outsource these functions to entrusted partners.

Bushu Pharma’s partner, Suzuken, has played an industry-leading role in the pharmaceutical distribution sector in Japan. Suzuken, one of the largest companies in that sector, possesses a distribution network in Japan that can support the international transportation of specialty pharmaceuticals. On the other hand, Bushu Pharma has been engaged in the contract manufacturing business in Japan for more than 20 years, holds GMP certifications from all over the world, and has a track record of exporting to more than 43 countries. By aligning functions and capabilities with Suzuken, Bushu Pharma will create a platform that enables one-stop comprehensive support for pharmaceutical manufacturers looking to enter the Japanese market.

Alliance Details

(1) Establish a one-stop logistics center in Soka City, Saitama Prefecture, for manufacturing operations and general logistics.

By securing up an area within the planned Metropolitan Area Distribution Center (Soka City, Saitama Prefecture), Bushu Pharma will be able to conduct contract manufacturing operations and the two companies will work together to offer one-stop services for specialty pharmaceuticals, including MAH (marketing authorization holder/drug approval holder), consulting, import, inspection, manufacturing, storage (manufacturer logistics), wholesale distribution, PMS (post-marketing survey), and patient support.

In addition, through use of the Cubixx specialty drug traceability system developed by Suzuken, Bushu Pharma aims to provide increasingly efficient and high-quality delivery of products all the way to patients. The Cubixx specialty drug traceability system can address the need to strictly monitor and control temperature for specialty drugs. Based on the use of this system, Bushu Pharma will be able to provide an environment in which medical professionals can offer medicines safely and securely without risk for patients.

URL: https://kyodonewsprwire.jp/attach/202104234117-O1-2Ko67p16.pdf

(2) Establish the Bushu Pharma Kazo Packaging Center within Suzuken subsidiary Chuo Unyu’s Kazo Pharmaceutical Joint Logistics Center and start contract manufacturing operations.

Bushu Pharma will utilize the spacious cold storage area -- spanning 1,465 sqm -- newly established within the Kazo Pharmaceutical Joint Distribution Center of Chuo Unyu Co., Ltd. (hereinafter “Chuo Unyu”), which is a consolidated subsidiary of Suzuken. The area will make it possible for Bushu Pharma to carry out contract manufacturing centered on secondary packaging such as inspection, labeling, and packaging.

(3) Initiate joint proposal business in the United States for pharmaceutical manufacturers aiming to enter the Japanese market.

Suzuken companies, including S.D. Collaboration Co., Ltd., which is a consolidated subsidiary of Suzuken, and Bushu Pharma, in addition to sharing staff between businesses, have also initiated joint proposal sales efforts to specialty pharmaceutical manufacturers who are planning to enter the Japanese market, led through Bushu Pharma’s U.S. office in North Carolina.

Tadao Takano, Chief Operational Officer and Executive Vice President at Bushu Pharma, said, “We are pleased to partner with Suzuken to provide comprehensive support for new product launches for specialty pharmaceutical manufacturers aiming to enter the Japan market. To realize our mission of ‘Supporting the global healthcare industry to create a healthier tomorrow,’ this new business alliance and facility is a great milestone. Additionally, it will become a significant asset to enable specialty drugs to launch in Japan and across the Asia-Pacific region going forward by optimizing their supply chain through our advanced Gateway to Asia (GTA) services. Bushu Pharma’s GTA services offering lets international pharmaceutical companies effectively import bulk products into Japan for quality inspection, labeling, packaging and distribution throughout Japan and Asia-Pacific.”

About Bushu Pharmaceuticals Ltd.

Drawing on its experience and knowledge as a contract development and manufacturing organization (CDMO) it has cultivated over 20 years, Bushu Pharma manufactures solid preparations, solid preparation primary packaging, injection manufacturing, and injection packaging not only for domestic pharmaceuticals but also for global pharmaceutical manufacturers. Bushu Pharma is capable of providing a wide range of products and services -- from clinical trial supplies to commercial product development support to commercialization -- and has numerous manufacturing facilities and technologies.

From project start to approval, Bushu Pharma is a leading domestic contract manufacturing company that can provide optimal solutions such as technology transfer, production, packaging, and logistics in Japan.

Please refer to Bushu Pharma’s homepage for details: https://www.bushu-pharma.com/en

Gateway to Asia details:

https://www.bushu-pharma.com/en/services/scm/gateway-to-asia/

Source: Bushu Pharmaceuticals Ltd.