Manufacturing Facility

In November 2006 we added a multi-purpose pharmaceutical intermediate manufacturing facility to the existing facility that was constructed in 2000. The new facility can be adapted for various processes with a great use of flexible hoses. It also is equipped with numbers of reaction vessels including 8,000 L-scale, centrifuges, and dryers.
Furthermore, the facility has a Class 100,000 clean room as well as reaction vessels including a 5000 L-scale, centrifuges and dryers. It not only conforms to cGMP, but also is especially designed to ensure an appropriate environment, safety, and health. The facility maintains a total production system for pharmaceutical intermediates as well as APIs.

The Iwate plant, where several drug substance manufacturing lines are in operation, has two manufacturing lines that conform to GMP for APIs including investigational drugs.

Line-1 is a manufacturing line equipped with 100-500 L-scale GL vessels as main apparatus. It consists of manufacturing facility that is designed to manufacture investigational drugs on a scale of 10-50 kilograms, covering from reaction through crystallization and isolation to drying, and a product room with dust control of Class 100,000 quality.

Line-2 is a manufacturing line equipped with 1-1.5 MT-scale equipments. It is capable of manufacturing APIs on a scale of 50-100 kilogram covering from reaction through crystallization and isolation to drying in series. The line also has a Class-100,000 product room.