Shares of pharma major Lupin slumped as much as 14.3 per cent on Tuesday to fresh 52-week low of Rs. 1,280 amid US regulatory concerns.
Brokerage IIFL in a note said that Lupin's Mandideep facility in Madhya Pradesh has received Form 483 from US Food and Drug Administration (US FDA) after an inspection. According to US regulator, a Form 483 is issued to a company at the conclusion of an inspection when investigators have observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
According to brokerage IIFL, the US regulator's observations are serious in nature and it could take 18 months for Lupin to address the issues. The US FDA inspection happened between February 8 and February 19, the brokerage added.
Lupin's US business is significantly dependent on Mandideep unit, which contributes revenues of more than $200 million annually, IIFL said.
The Bombay Stock Exchange has sought a clarification from Lupin over the matter.
Gaurang Shah of Geojit BNP Paribas Financial Services said that if the US regulator's observations are serious in nature then it could take a long time for Lupin to address the issues. That may translate into earnings disappointment, he added. Geojit BNP Paribas Financial Services will soon review its rating on the stock, Mr Shah added.
Including today's fall, Lupin's shares have lost nearly one-fourth of its value in the past one month over US regulatory concerns.
Lupin earlier this month said it has received nine observations relating to inadequacy and adherence to operating norms for its manufacturing plant in Goa from the US regulator.
At 10:37 a.m., Lupin shares were down 11 per cent at Rs. 1,331 as compared to a flat market.
.jpg)
