Analysis of Drug Master Files Registered in Japan: For the Stable Supply of Active Pharmaceutical Ingredients

Category: Original Research
Author(s): ,
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Keywords: API (active pharmaceutical ingredient), drug master file, generic drugs, globalization, stable supply

Introduction/Objectives: A stable supply of active pharmaceutical ingredients (APIs) is indispensable for the stable supply of finished pharmaceutical products (FPPs). API information is generally registered by API manufacturers as a drug master file (DMF) directly to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. It is important to clarify the DMF registrants’ distribution, because DMFs require appropriate management by their registrants. However, despite globalization of the API supply chain, details regarding DMF registration situation in Japan have not been reported. Therefore, we surveyed the status of globalization and characteristics of DMF registrations in Japan.
Methods: We examined the total number of DMFs, the number of DMFs by country and region of registrants, profile, and for the same APIs, using the DMF registration information on the PMDA website.
Results: Of the 3804 DMFs registered in Japan, 63.46% of DMFs were registered by foreign manufacturers. DMFs were registered from 46 countries and regions of seven continents, and mostly registered by Asian and European manufacturers including Japan, China, India, South Korea, Italy, and Spain. In recent years, approximately 200–300 DMFs have been registered annually. 10 or more DMFs were registered for some APIs in the top 30 FPPs.
Discussion and conclusion: It is very important that the Japanese DMF system and its related regulations are understood by all DMF registrants including foreign registrants for appropriate management of their DMFs. Our results represent a key consideration for future DMF system and regulation, corresponding to the globalization of DMF registration.

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