"Caplin Point has received the Establishment Inspection Report (EIR) from USFDA (The United States Food and Drug Administration) for inspection carried out during Oct 21-27, 2016, at its sterile injectable plant at Gummidopoondi in Tamil Nadu," Caplin Point Laboratories said in a filing to BSE.
"This will pave the way for our entry into the largest pharma market in the world," Caplin Point Laboratories Chairman C C Paarthipan said.
The 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.