Caplin Point Laboratories has received the Establishment Inspection Report from the US health regulator for its Gummidopoondi facility in Chennai.
“Caplin Point has received the Establishment Inspection Report (EIR) from USFDA (United States Food and Drug Administration) for inspection carried out during October 21-27, 2016, at its sterile injectable plant at Gummidopoondi in Tamil Nadu,” Caplin Point Laboratories said in a filing to the BSE today.
“This will pave the way for our entry into the largest pharma market in the world,” Caplin Point Laboratories Chairman C C Paarthipan said.
USFDA releases a copy of the EIR to the establishment that was the subject of an FDA or FDA-contracted inspection when the agency determines the inspection to be closed.
Shares of Caplin Point Laboratories were trading at Rs 397.30 on BSE, up 2.60 per cent from their previous close.