Alkem Laboratories announced that it has received letter from the US FDA classifying the inspection conducted at its St. Louis facility as Official Action Indicated (OAI).
St. Louis facility contributes about 2% of the Company's total US revenues or about 0.5% of the Company's consolidated revenues. The Company believes that this classification will not have any significant impact on existing supplies or the existing revenues from the operations of this facility.
The Company shall continue to work closely with US FDA to close out all the observations associated with this inspection.
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