Drug major Lupin today said supply of products manufactured at its Mandideep facility will not be affected despite the US Food and Drug Administration (USFDA) listing as many as 15 observations to be addressed after inspecting the plant.
"The outcome of this inspection does not affect the supply of products manufactured at this facility (Mandideep) across the world, or the approvability of pending applications with the USFDA," the company said in a filing to the Bombay Stock Exchange.
The USFDA had inspected the manufacturing plant as a part of "routine Good Manufacturing Practice," the company said. An inspection report was issued listing 15 inspectional observations. Lupin addressed and presented its actions to eight of these observations right away, the company said. "A complete report to all the observations will be submitted to the FDA expeditiously," the statement added.
The Mandideep facility was earlier inspected in 2003 and 2006, the firm received nine inspectional observations, which were addressed and found acceptable, and the following inspection in 2006 resulted in no inspectional observations, the company said.
"Lupin continues to manufacture and test all products in accordance with the USFDA requirements," it said. The company's shares were trading at Rs 586, down 3.72 per cent in afternoon trade on the BSE.