Drugmakers keen on expanded coverage of DMF system

Published: 2010-09-10 07:00:00

Updated: 2010-09-10 07:00:00

The Korea Food and Drug Administration is considering providing assistance to industry, in particular Active Pharmaceutical Ingredient (API) manufacturers, on the requirements of drug substance as the drug agency intends to formulate the guideline aiming to expand the current scope of drug master file system to excipients in addition to API from 2015.

This guidance will apply to all DMF owne...

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