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Lupin said it has received a letter from the US FDA classifying the inspection conducted at its Pithampur (Indore) unit-2 in January as Official Action Indicated. The FDA has stated that the facility may be subject to regulatory/administrative action and may withhold approval of any pending applications or supplements. However, Lupin said it does not believe this classification will have an impact on disruption of supplies or the existing revenues from operations of this unit.
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