FDC with ascorbic acid [Regulatives / Guidelines]

posted by qualityassurance – 2024-07-23 10:08 (304 d 04:37 ago) – Posting: # 24087
Views: 3,280

Dear Forum members,

In case FDC (two active ingredients) with ascorbic acid is not approved in Europe. However, FDC (two active ingredients) is approved. In case if we want to apply for FDC (two active ingredients) with ascorbic acid in Europe, is it needed to conduct any safety and efficacy study in patients or only BE study will be enough justifying that ascorbic acid is used as an excipient?

Regards,
QA

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