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South Korea KDMF Requirements for Imported APIs
Welcome to the DDReg Knowledge Capsule" — This episode provides a practical overview of South Korea's Korea Drug Master File (KDMF) registration framework managed by the Ministry of Food and Drug Safety (MFDS) for imported active pharmaceutical ingredients (APIs). It explains how to determine registration scope, adapt global technical packages (such as US DMFs, ASMFs, or CEPs) to satisfy Korean requirements, choose between standalone and linked submission pathways, and maintain ongoing post-approval compliancevisit our blog -…
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