Lupin jumps 8 % as USFDA issues EIR for Goa plant

Drug major Lupin in an exchange filing over the weekend informed the bourses of receiving EIR (Establishment Inspection Report) for the Goa plant from US FDA for the inspection held in March 2016.

Pharma major, Lupin Limited has announced today that it has received notification that the inspection carried out by the US FDA in March 2016 at its Goa facility is now closed and the agency has issued an Establishment Inspection Report (EIR).  After receiving the EIR it closes all outstanding US FDA inspections at Lupin’s Goa facility.

Commenting on the receipt of the EIR, Vinita Gupta, CEO and Nilesh Gupta, MD, Lupin said “We are committed to ensuring that all systems and processes followed by Lupin are compliant with cGMP and are committed to bringing quality products to market. We are grateful for the US FDA’s confidence in our corrective action plan and in our team”.

USFDA usually releases a copy of the EIR to the establishment that was the subject of an FDA inspection when the agency determines the inspection to be closed.

This also holds importance as the company has filed several key products from Goa facility. After the EIR it is expected that in coming months Lupin is likely to receive approvals from the regulator.

Reacting to this positive development, shares of Lupin have soared more than 8 per cent intra-day to hit a high of Rs 1534 on NSE.