The US Food and Drug Administration (FDA) has cleared Lupin’s Goa plant paving the way for new product approvals.
The Goa plant has an annual capacity for producing 6 billion units of tablets, capsules or oral suspension drugs. It accounts for 18-20 per cent of the drug maker’s US revenue.
On Wednesday, Lupin announced that the US FDA has issued an establishment inspection report with a voluntary action-indicated status for the Goa plant. The plant was served a warning letter in 2017. It had received seven observations from the US regulator after its inspection in September. The company’s stock gained