Sun Pharmaceuticals Industries has received a communication from the USFDA indicating that the Halol facility has been classified as Official Action Indicated (OAI). The OAI classification implies interalia that the USFDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved. The Company continues to manufacture and distribute existing products for the US market, thereby not likely to have any adverse impact on current business from the facility.
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