Stocks

Lupin shares fall 4% on USFDA action

PTI New Delhi | Updated on March 18, 2019 Published on March 18, 2019

Shares of Lupin Monday fell by 4 per cent after the company said it has been cautioned by the US health regulator that its Somerset (New Jersey) facility may be subject to regulatory or administrative action.

The shares declined 3.92 per cent to close at Rs 754.50 on BSE. During the day, it plunged 5.59 per cent to Rs 741.35.

At NSE, the shares dropped 3.98 per cent to close at Rs 753.90 .

Lupin on Saturday said it has been cautioned by the US Food and Drug Administration (USFDA) that its Somerset facility may be subject to regulatory or administrative action, and the regulator may withhold approval of any pending applications or supplements in which this facility is listed.

The company’s subsidiary Novel Laboratories Inc has received a letter from USFDA classifying the inspection conducted at its Somerset (New Jersey) facility in December 2018, as Official Action Indicated (OAI), Lupin said in a regulatory filing.

‘Official Action Indicated’, means approvals of pending applications or supplements from the site maybe withheld.

“The company is in the process of sending further updates of its corrective actions to the USFDA and is hopeful of a positive outcome,” Lupin added.

Published on March 18, 2019
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