US FDA observations not to affect drug sales: Lupin
14 Nov 2008
Drug major Lupin today said supply of products manufactured at its Mandideep facility will not be affected despite the US Food and Drug Administration (US FDA) listing as many as 15 observations after inspecting the plant.
Lupin said the FDA inspection report (FDA-483) has listed 15 inspectional observations and Lupin has addressed and presented its action in response to eight of these observations right away.
The US FDA has completed an inspection of Lupin's manufacturing facility in Mandideep. The inspection was a routine good manufacturing practice (GMP) audit, Lupin said on Friday.
"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 with the Bombay Stock Exchange.
Lupin said a complete response to all the observations will be submitted to FDA expeditiously, adding that the outcome of the inspection does not affect the supply of the products manufactured at this facility to market across the world, or the approvability of pending applications with the USFDA.
The Mandideep facility was earlier inspected in 2003 and 2006. In 2003, the firm received 9 inspectional observations which were addresses and found acceptable, and the following inspection in 2006 resulted in no inspectional observations.
Lupin continues to manufacture and test all the products in accordance with US FDA requirements, the company said in a release.
