Panacea Biotec receives EIR from USFDA for Baddi facilities

Drug firm Panacea Biotec has received Establishment Inspection Report (EIR) from the US health regulator after successful inspection of its manufacturing facilities at Baddi in Himachal Pradesh.
The company has received EIR from the US Food and Drug Administration (USFDA) indicating the formal closure of the cGMP and pre-approval inspection conducted at its oncology parenteral and oral solids dosage formulation facilities at Baddi, Panacea Biotec said in a BSE filing.
"The company has been supplying products in the US markets for approved ANDAs manufactured in the oral solids dosage facility," it added.
This facility has completed four consecutive successful cGMP and pre-approval inspections by USFDA in last 7 years, Panacea Biotec said.

The manufacturing facility of oncology parenteral formulations has been inspected by the USFDA for the first time, it added.
Both the facilities were inspected at the same time, between November 30-December 11, 2015 by the the US health regulator.

Panacea Biotec Joint MD Rajesh Jain said: "This EIR notification demonstrates the company's ability to produce drugs in cGMP compliant environment in a sustainable manner".
The EIR notification indicating inspection activity 'closed' means that the company is allowed to continue to sell its USFDA approved drug products. This also accelerates the approval process for submitted drug product applications, Panacea Biotec said.

Panacea stock was trading 3.27 per cent higher at Rs 108.95 apiece in the afternoon on BSE.