Initiatives to Provide Stable Supplies
Establishment of a Stable Supply System
At Sumitomo Dainippon Pharma, our greatest mission as a pharmaceutical company is to provide a stable supply of high-quality pharmaceuticals made in fundamentally sound, safe operations.
In order to fulfill this mission, we perform inspections at multiple stages for each product lot, verifying the quality of materials at all stages of the manufacturing process from receipt of raw materials through the final inspection of products to be delivered, to determine if there are any irregularities in quality and if the products have been manufactured according to the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan and Good Manufacturing Practice (GMP)*1. Only products that have passed all of these inspections are shipped.
※1：Good Manufacturing Practice: A standard for managing the manufacturing and quality of pharmaceuticals and quasi-pharmaceuticals.
We have built a stable supply structure for its products, which are manufactured at four plants in Japan--in Suzuka, Ibaraki, Ehime and Oita--and also in collaboration with contract manufacturing partners in Japan and other countries.
Our plants have worked hard to increase the precision of their production plans by collaborating closely with the Sales & Marketing Division. They have also made efforts to establish backup systems such as double sourcing of active pharmaceutical ingredients and to streamline formulation and packaging sites. To further strengthen our competitiveness, we work to improve cost efficiency, including reviewing expenses, as well as actively striving to increase productivity in our factories such as by reducing lead times.
The Suzuka Plant is being developed into our core formulation plant, with a state-of-the-art solid dosage formulation facility fully compliant with cGMP (the latest U.S. GMP) constructed in 2008. The plant maintains integrated pharmaceutical manufacturing facilities at which a full range of operations are conducted, from production of active pharmaceutical ingredients and finished products to packaging. The Suzuka Plant is responsible for global supply of LATUDA® tablets, our atypical antipsychotic and one of Sumitomo Dainippon Pharma's strongest selling products.
The Ibaraki Plant, which is also the main base of the Technology Research and Development Division, is a development-driven pharmaceutical plant able to accommodate new products and technologies, from drug formulation research through commercialization and production, in a flexible manner. It produces drugs in a broad range of dosage forms. In fiscal 2012, Sumitomo Dainippon Pharma undertook capital investment to expand plant facilities in order to accommodate the increase in production stemming from the launch of the anti-hypertensive drug, AIMIX® Combination Tablets LD/HD.
One of the world's largest biopharmaceutical production facilities, the Ehime Plant functions as a key manufacturing base for biopharmaceuticals and also manufactures sterile injections in a full containment facility.
The Oita Plant is our core facility for the production of active pharmaceutical ingredients and its equipment is cGMP-compliant. The plant, which also handles high-potency active pharmaceutical ingredients and drug formulations, ships its products to countries around the world.
Strengthening the Global Supply Chain
To further strengthen our stable supply system, we will continue to reinforce our global supply chain based on the progress of globalization, including the overseas procurement of raw materials and pharmaceutical intermediates and manufacturing at overseas plants.
To ensure the stable and sustainable procurement of the raw materials and other items used in its products, Sumitomo Dainippon Pharma continuously and systematically promotes measures to prevent interruption of its supply of raw materials, including the use of multiple suppliers, taking alternative materials into consideration and maintaining appropriate inventories.
Currently, the company is working on measures for individual products. In fiscal 2014, we conducted a review of production strategy accompanying the global expansion of our main products and the reorganization of our production sites.
Especially, we established our production system for LATUDA®, a global strategic product. With active pharmaceutical ingredients manufactured at Oita Plant, we set up a system for formulation at contract manufacturers in Japan and the U.S., in addition to our own plants. In its overseas procurement, in addition to dealing speedily with problems as a matter of course, we work to prevent problems from occurring and eliminate supply uncertainties by building deeper relationships of trust through smooth communication with overseas business partners and trustworthy procurement activities.
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To Respond Flexibly to Changes in the Business Environment
The environment surrounding the pharmaceuticals industry is becoming increasingly challenging. This includes encouragement of the use of generic medicines and the strengthening of controls on healthcare costs, such as NHI price reductions on long-listed brands. To accommodate such changes in the business environment, Sumitomo Dainippon Pharma decided to reorganize its production sites in order to build a stable and efficient production system that can respond flexibly to swings in production volumes and maintain and improve our cost competitiveness. By doing this, our production sites will be integrated into two: Suzuka Plant and Oita Plant, the core facility for the production of active pharmaceutical ingredients. Going forward, we will efficiently implement activities aimed at integrating our production sites and reduce manufacturing costs while conducting stable production and supply of safe and secure products.
Strengthening the Distribution System
Our east and west Japan distribution centers are located in Kobe (Hyogo Prefecture) and Kazo (Saitama Prefecture), respectively. Shipment rates have steadily increased thanks to efforts to strengthen our 24-hour delivery system, under which products are delivered within 24 hours of the time the order is placed. Sumitomo Dainippon Pharma has always accommodated 24-hour delivery turnaround for the Kinki region and the greater Tokyo metropolitan area (the entire Kanto region). Recently, however, we have added parts of the Chugoku and Tohoku regions to this service. We are working to strengthen the supplementary functions of the east and west Japan distribution centers to maintain a stable supply not only in normal times but also in the event of a disaster or other emergency.