Product Supply System

Obtaining approval for the manufacture of a pharmaceutical product requires the manufacturer to undergo a detailed examination on the method of manufacturing the product.

Before the 2002 revision of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices was implemented in April 2005, if the APIs of a formulation product were manufactured by companies other than the manufacturer of the formulation product, the manufacturer of the formulation product had to apply for approval for the product by including in the application form an explanation of the methods of manufacturing the APIs, although such information included the know-how and intellectual property of the API manufacturers.

The 2002 revision of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices provides that a new system should be adopted to enable formulation product manufacturers to undergo an examination for approval without having API manufacturers disclose intellectual property information to the formulation product manufacturers. This system is aimed at protecting information about the know-how of API manufacturers. This is the master file (MF) registration system.

Registering MFs for pharmaceutical products is not mandatory, but most manufacturers that intend to sell their products—for example, APIs for generic drugs—to multiple companies register MFs for their API products.

Our group has the most registered MFs in Japan, counting up to 106 across the group (as of the end of May 2025), and has built a supply system that can handle the manufacturing of a variety of APIs.