USFDA clears Lupin's Goa plant, closes July 2015 inspection

The Goa plant accounts for 50% of Lupin's US sales and adverse observations from FDA resulted in delayed product approvals for the company

Lupin has secured a partial relief as the US Food and Drug Administration has closed the July 2015 inspection of its Goa plant.

The Goa plant accounts for 50 per cent of Lupin’s US sales and adverse observations from FDA resulted in delayed product approvals for the company. The company stock gained 6.25 per cent to close at Rs 1,657.30 following the announcement.

FDA inspected the Goa plant last July and again in March this year. It made nine adverse observations following its March inspection.

In a notification to the stock exchange on Thursday, Lupin said the inspection carried out in last July has been closed and it has received establishment inspection report from the regulator.

“However, the responses from March 2016 US FDA inspection and updates thereafter are still under review by the agency,” Lupin said.

An industry analyst said chances of the regulator issuing an import alert or a warning letter to Lupin are now minimal.

“We will have to see whether the company begins receiving approvals for Goa plant,” he said.

In May, Lupin received US FDA clearance for its facilities at Mandideep and Aurangabad. Both the plants had received adverse observations from the US FDA during the inspections in January and February.

US market contributes to over 40 per cent of Lupin’s business and the firm expects to grow the business with the launch of new products from its US arm Gavis and contribution from anti-diabetes drug Glumetza for which it has 180-day sale exclusivity.