US FDA inspections in India set to increase post lockdown
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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