Lupin received yet another regulatory setback after the inspection of its Mandideep manufacturing facility (Unit 1) in Madhya Pradesh by the United States Federal Drug Administration (USFDA). The unit, which was classified as OAI or Official Action Indicated, may see an escalation of issues and difficulties in receiving approvals for new drug launches from there.
But, there are no new filings from the facility and no supply disruption is expected given the seasonality as cephalosporins (anti-bacterial) basket sales are less than $100 million. This is why analysts see a limited financial impact of the USFDA actions on the company.
However, given the

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