Drug firm Claris Lifesciences has received the Establishment Inspection Report (EIR) from the US health regulator for its manufacturing plant near Ahmedabad.
The company has "received the EIR for its manufacturing facility located near Ahmedabad, wherein the US Food and Drug Administration (USFDA) has concluded that the inspection stands closed and the facility was found to be acceptable," Claris Lifesciences said in a filing to BSE.
The USFDA had conducted audit at Claris' manufacturing facility in May, 2015, it added.
"The company had taken appropriate steps to address the observations it had received from these audits," Claris Lifesciences said.
Having received the EIR from the USFDA potentially clears the path for the company to receive product approvals (ANDA) for the USA, it added.
The company presently has 13 ANDAs approved in the US and has an additional 26 ANDAs under approval there, Claris said.
Shares of Claris Lifesciences today closed at Rs 201.90 on BSE, a steep jump of 20 per cent from the previous close.
