KFDA revises regulations on novel salt preparations

Published: 2004-06-09 07:00:00

Updated: 2004-06-09 07:00:00

A person who intends to obtain a manufacturing license for novel salt preparations should submit bioequivalence-tested data to the Korea Food and Drug Administration. But in the case of product approval for generic versions of Pfizer's amlodipine, a new applicant should necessarily conduct clinic...

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