Lupin shares fall after USFDA Goa plant observations1 min read . Updated: 27 May 2019, 11:28 AM IST
- The company’s stock was lowest in the morning since 28 March
- The share of Lupin fell nearly 10% this year as of the last close
New Delhi: Shares of the drug major, Lupin tumbled up to 5% on Monday morning after the company notified about getting two observations post-Goa plant inspection.
The United States Food and Drug Administrator (USFDA) has stated with the two observations, FDA classified inspection as official action indicated (OAI). “The drug regulator has stated that this facility may be subject to regulatory or administrative action and that it may withhold approval of any pending applications or supplements in which this facility is listed," a statement from the company said.
Based on USFDA's Concept of Operations program, the company said it understands that the status of the facility is still under review.
The company’s stock was lowest in the morning since 28 March. The stock is the major dragger on Nifty Pharma falling 2.16% at ₹742.55. The Pharma index is also down by 0.20%. The share of Lupin fell nearly 10% this year as of the last close.
Lupin also said in the statement that it does not believe that this inspection classification will have an impact on the disruption of supplies or the existing revenues from operations of this facility.
Earlier, the USFDA had classified the inspection conducted at Pithampur facility and its Somerset (New Jersey) facility in April 2019 and December 2018, respectively, as OAI, which means approvals of pending applications or supplements from the site may be withheld.
According to OAI classification, US drug regulator says facility may be subject to regulatory or administrative action, FDA may withhold approval of any pending applications or supplements in which this facility is listed.
Shares of Lupin was trading at ₹748 down 1.96% on both BSE and NSE.
(With inputs from Reuters)