Manufacturing

We have a manufacturing structure that ensures stable supplies of highly reliable products underscored by a commitment to low-cost operations. For this, we draw on our three production facilities to achieve overall optimization of all manufactured products and appropriate capital investment.

As a result, we reached our cost reduction targets and increased production volume at each plant. However, business conditions are changing dramatically, characterized by stricter quality requirements, rising manufacturing costs, and more sophisticated manufacturing technologies. In response, we must take new measures to maintain a stable supply of high-quality products.

Under the medium-term business plan “Vision 110 –Stage1–,” one of our business strategies is to “strengthen production capacity for drugs and reduce manufacturing costs.” By strengthening our product supply capacity and raising the GMP*1 level, we aim to achieve low-cost production and a stable supply of high-quality products, increase subcontracted manufacturing contracts from outside the Kyorin Group, and establish a competitive manufacturing structure.

Changing environment(internal and external)

  • Increasing demand for pharmaceutical companies to ensure reliability
  • Rising manufacturing costs
  • Changes in manufacturing technologies

Opportunities

  • Growing need for subcontracted manufacturing for foreign companies entering the Japanese market
  • Response to demand by growth of generic products
  • Increased requests for stable supply of high-quality products

Risks

  • Annual drug price revisions that translate to higher cost of sales ratio
  • Higher raw material prices due to increasing crude oil prices and logistics costs
  • Delays and suspension of manufacturing activities and raw materials procurement due to pandemics, natural disasters, unstable social situations, etc.

Medium-term business plan
Vision 110 –Stage1– initiatives

Business StrategyStrengthening production capacity for drugs and reduce manufacturing costs

  • Maximize production capacity through reliable operation of Takaoka Plant and overall optimization of other plants
  • Improve reliability and maintain stable production by raising the GMP level
  • Reduce costs through continuous improvement activities

Initiatives under the medium-term business plan

Establish a new manufacturing structure by constructing the Takaoka Plant

In line with the increase in our pharmaceutical manufacturing volume, we need to strengthen our production and supply capacity. With this in mind, we are building a new plant in Takaoka City, Toyama Prefecture.

The new facility will increase the production of tablets (oral solid formulations) and further raise the GMP level. It will also streamline various processes and improve manufacturing efficiency, thus assuring stable supplies and low-cost manufacturing.

In addition, it will reduce our environmental impact by actively utilizing renewable energy sources. The new plant is scheduled to start operations in April 2024, enabling us to quickly realize stable supplies and lower costs through a four-plant system.

Improve reliability and maintain product quality

In recent years, quality requirements for products have become more stringent. In response, we are working to maintain quality through various approaches, including cross-facility reciprocal audits of GMPs, reinforcement of data integrity (framework ensuring data is complete, consistent, and accurate), regular training and testing of employees, and the use of video to teach standardized operations.

In these ways, we are working relentlessly to provide products that earn the confidence of medical practitioners and patients.

Increase production efficiency to improve cost competitiveness

We are working to establish a manufacturing structure that ensures stable supplies of new and generic drugs and low-cost production.

During the production process, we utilize various practices to improve manufacturing quality, including enhancing production techniques and acquiring new technologies. Going forward, we will strive to improve production efficiency by appropriately deploying resources and improving processes to ensure low-cost operations and increases in production volume.

In these ways, we will solidify our structure to improve cost competitiveness.

Overall optimization of our manufacturing system

Aiming to maximize our manufacturing capacity, we are pursuing an optimal combination of manufacturing items and sites by taking advantage of the characteristics of each of our three plants.

The Noshiro Plant produces not only new drugs, mainly tablets and capsules, but also generics in large volumes. The Shiga Plant actively engages in subcontracted manufacturing. It has a high ratio of manufacturing subcontracted from outside the Group, including the manufacture of pharmaceutical products to be sold in Japan by foreign pharmaceutical companies.

The Inami Plant mainly handles generic drugs but also manufactures solid formulations taken internally and eyedrops. All three plants are working to raise GMP levels and maintain and improve quality-control systems, while establishing PIC/S*2 GMP compliance and building a supply system for both domestic and overseas markets.

We will continue making aggressive capital investments, including those at the Takaoka Plant, to further improve productivity and ensure reliability.

Supply chain management (SCM)

In light of changing business conditions, we have established a system to ensure stable product supplies. We centrally manage and visualize suppliers’ inventory information and the supply plans for all regions around the world to address demand forecasts for each product. This setup enables us to globally manage every stage, from the manufacture of pharmaceutical ingredients to the supply of products. Looking ahead, we will strive to build an even stronger supply chain to flexibly address changing business conditions.

Our pharmaceutical supply chain, which encompasses a wide variety of items including raw materials, intermediates, and pharmaceutical ingredients, is supported by numerous suppliers in Japan and overseas. To continue providing stable supplies without interruption in the procurement chain, we consider it imperative to strengthen relationships with individual suppliers by working closely and sharing information with them. Several challenges have emerged in the past few years, including geopolitical risks, exchange rate fluctuations, rising raw material prices due to rising energy costs and semiconductor shortages, and a logistics problem in 2024.

Nevertheless, the Kyorin Group will continuously strive to ensure stable product supplies by reducing various risks through production planning and inventory coordination with internal manufacturers and external subcontracted manufacturers, while developing multiple and alternative suppliers and improving logistics efficiency.

Photo: Noshiro Plant

Noshiro Plant

Environment management system: ISO 14001

Occupational health and safety management system: ISO 45001

Photo: Shiga Plant

Shiga Plant

Environment management system: ISO 14001

Occupational health and safety management system: ISO 45001

Photo: Inami Plant

Inami Plant

Environment management system: ISO 14001

Occupational health and safety management system: ISO 45001