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Motilal Oswal Report
In this note, we have analysed the developments on the U.S. Food and Drug Administration inspection front at the global level and in India in particular.
The pace of U.S. FDA inspections is already increasing in the U.S. (50% of its pre-Covid five-year average in the 11-months ending August 2022 versus 31% of its pre-Covid five-year average for the 12-months ending September 2021).
We expect the number of U.S. FDA inspections to improve gradually in geographies other than the U.S. as well.
In fact, India had 38 U.S. FDA inspections over the past 12-months, with 18 sites awaiting citation from the U.S. FDA.
Regulatory compliance from the U.S. FDA continues to pose a risk to Indian pharma companies having an exposure to U.S. generics, with 60 official action indicated citations yet to be resolved.
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