US FDA inspections in India set to increase post lockdown

7 July 2020

The stringent regulatory vigilance by the US Food and Drug Administration is expected to continue with an increase in the number of inspections and re-inspection of Indian pharma facilities to clear the overall backlog.

The US FDA had postponed facility inspections from April 2020 due to the COVID-19 lockdown.

While this has impacted new approvals and clearance for facilities, Indian companies have used the time to build a strong abbreviated new drug application (ANDA) pipeline.

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