Manufacturing APIs in compliance with GMP


About manufacturing APIs

  • We manufacture a wide range of APIs based on the appropriate control system which complies with the regulations of international GMP* such as ICH* guidelines. Production activities operate daily at our two factories that are experienced in obtaining FDA* approval by paying special attention to a variety of points such as not only high quality but also productivity, costs, safety, environmental influence, etc.
  • We achieve the consistent suppply of safe and secure APIs by implementing three principles based on “Katsura Chemical Quality” 1 high quality, 2 high added value and 3 flexible service. You will find details on our three principles below:
  • *GMP: Good Manufacturing Practice
    *ICH: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
    *FDA: Food and Drug Administration

  • About GMP for APIs


  • POINT1 高品質
  • POINT2 高付加価値
  • POINT3 柔軟な対応

High quality

1High quality product consciousness made in Japan


Day-to-day production activities are conducted in accordance with various operating procedures managed by the quality department. In our plant, GMP conditions are in full compliance, for example, with the status of the equipment used and plumbing are indicated clearly for easy understanding. Based on our specialist knowledge cultivated from 70 years of our experience on the manufacturing floor, we continually work on improving and manufacturing world-leading high-quality products “made in Japan”. We are proud to offer the world these products by utilising our strengths in the craftsmanship and expertise cultivated as a result of our long-standing experience. As we move forward, we proactively install new equipment and expand our plants to remain committed to supplying high-quality APIs always conscious of them being “made in Japan”.

Quality assuranceProduct information

High added value

2High added value for our clients


Not only do we manufacture high quality pharmaceutical products, we also supply our products with an excellent standard of service in order to give our clients a high level of added value. In the production department, in addition to fostering GMP, we continue and pass on to the next generation the manufacturing technology which is based on many years of experience and expertise. In the quality control department, we monitor the trend of product quality in full compliance with GMP requirements. In the sales department, we work on promoting a good working relationship and cooperation by offering a comprehensive service which meets the needs of our clients. In this way, each department assumes their own roles and work well together so that we can supply APIs with “Katsura Chemical Quality”, delivering products of the finest quality whilst at the same time providing an excellent standard of service worldwide.

Flexible service

3Prompt and flexible service meets demands


Our production line is able to deal with a wide range of products.

We manufacture APIs as our major products. These also include APIs for investigational drugs as well as raw materials for cosmetics. Our production line is able to deal with a wide range of products that cover a manufacturing volume from small scale of a few hundred grams to a large scale of a few tons.



Expert knowledge from a 70-year track record of long-standing experience

We manufacture APIs by applying various chemical reactions such as organic synthesis using many different kinds of special reagents and catalysts. In addition, we are also able to manufacture high-quality APIs with a complex chemical structure by making full use of the purification technology of our own creation and many different types of manufacturing equipment.
Our expertise from the wide range of experience and proven track record of business over the past 70 years enable us to provide a prompt and flexible service that meets the need of our clients.

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