New Delhi : Pharma firm Lupin has received Establishment Inspection Report (EIR) from the US health regulator for its Goa facility regarding a inspection done by the USFDA in July last year.
The company “has received notification that the inspection carried out by the United States Food and Drug Administration (USFDA) in July 2015 at its Goa facility is now closed and the agency has now issued an EIR,” Lupin said in a filing to BSE.
However the responses from March’s USFDA inspection and updates thereafter are still under the review of the agency, it added.
The company’s Goa facility supplies over 100 products to various regulated markets including the US and EU. The plant has filed more than 115 abbreviated new drug applications (ANDA’s) in the US market.
Lupin has also filed for ANDAs for markets like the EU, Japan and Brazil from the facility.
Shares of Lupin closed at Rs 1,657.30 on BSE, up 6.25 per cent from the previous close.