Despite the action initiated by the US FDA on Lupin’s Mandideep facility, Lupin, almost defiantly, remains in the green. The initial reaction was a drop – it fell but just around 1% to Rs.755 and from there is bounced back and is now at Rs.769 levels, up almost 1%.
The company has received a letter from the U.S. FDA classifying the inspection conducted at the company's Mandideep (Unit 1) facility in December 2018 as 'Official Action Indicated' (OAI).
The FDA 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 company has stated that there are no new DMF and ANDA applications pending review or approval from the Mandideep (Unit 1) facility and it does not believe that this classification will have an impact on disruption of supplies or the existing revenues from operations of this facility.
This facility contributes less than 10% of US revenue and the experts in the field say that this OAI will not impact the sale of products which have already received an approval and being sold in the US markets.
Lupin is yet to resolve the ‘Observations’ it received from the FDA in Nov’17 for its Goa and Indore plants.