Can a drug substance from two or more manufacturers be submitted for a DMF application in one case, or separately?

刊登日期：2020-07-22 | 點閱次數 : 749 次

It should be submitted separately. The information stated on the DMF approval letter is related to the drug substance and its’ manufacturer, so each DMF submission is only for one manufacturer.

(中文版)

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Can a drug substance from two or more manufacturers be submitted for a DMF application in one case, or separately?

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