Pharmaceutical Executive November 3, 2025
Mike Hollan, Marcel Botha

Marcel Botha, CEO of 10XBeta, discusses FDA’s new pilot authorization program for abbreviated new drug applications (ANDA) and what impact it will have on manufacturing and the supply chain.

Pharmaceutical Executive: What impact will FDA’s ANDA Prioritization Pilot have on the global supply chain?
Marcel Botha: We saw consolidation during the pandemic. While it might have had some cost-savings implications, it exposed us to extreme risk. In the recent past, we saw the supply-chain issues. Recently, we’re seeing geopolitical and tariff related issues.

We’re seeing flows of product between Russia and Europe be interrupted, along with the flow of product between the US and China. It’s not just from what happened during the pandemic, but it’s also stemming from...

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