Lupin declines 5% as USFDA classifies inspection as OAI

The inspection at the Goa facility had closed with two observations.

Shares of Lupin declined 5.5 percent in the early trade on Monday after USFDA classified the inspection as official action indicated (OAI).


The company has received a communication from the USFDA classifying the inspection conducted at its Goa facility between January 28 to February 8, 2019, as OAI, company said in a release.

The USFDA 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.

The inspection at the Goa facility had closed with two observations.

Based on USFDA's concept of operations program, the company understands that the status of the facility is still under review.

The company 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, it added.

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

At 09:23 hrs Lupin was quoting at Rs 733.00, down Rs 29.95, or 3.93 percent on the BSE.

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