Analysis of Drug Master Files registered in Japan: aiming for a stable supply of active pharmaceutical ingredients

Author(s): Maki Matsuhama, MSc, Ryosuke Kuribayashi, PhD

Introduction/Study objectives: A stable supply of active pharmaceutical ingredients (APIs) is indispensable for a stable supply of finished pharmaceutical products (FPPs). API manufacturers generally register API information as a Drug Master File (DMF) directly to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Because DMFs require appropriate management by their registrants, it is important […]

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