Regulatory Open Forum

Would adding a new alternative excipient supplier not previously reported in the application and using the material from new supplier to manufacture commercial batches require regulatory notification to FDA? The excipients will be of equivalent quality but they will have slightly different specifications as per different suppliers specs.

If so, CBE-0, 30 or the annual report ?

If its a functional excipient then you need to evaluate its equivalency internally and if found no difference I'd file it under AR. You may have to consider placing it on stability and provide data in the subsequent ARs