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Lupin's Goa plant gets 7 observations from USFDA, firm unperturbed

Says confident of resolving matter, does not share nature of observations

Lupin
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Lupin

Sohini Das Mumbai
Mumbai-based drugmaker said on Sunday that its Goa facility has received seven observations from the US drug regulator. At present, five sites of Lupin either have warning letters of Official Action Indicated (OAI) status from the US Food and Drug Administration.

In a stock exchange notification, Lupin said: “We wish to inform you that the US FDA has concluded an inspection at our Goa facility in India. The inspection was carried out from September 6, 2021 to September 18, 2021 and closed with seven observations.” Exact revenue contribution from the Goa facility is not known.

The company, however, is confident
Topics : Lupin USFDA