homebusiness Newscompanies NewsGland Pharma gets EIR from USFDA for Visakhapatnam facility

Gland Pharma gets EIR from USFDA for Visakhapatnam facility

The inspection has been closed by the US FDA. The US agency had inspected Gland Pharma's Visakhapatnam unit from July 20 to July 28 this year, the company said.

By Meghna Sen  Nov 8, 2023 11:58:08 AM IST (Published)

2 Min Read

Pharmaceutical company Gland Pharma on Wednesday announced that it has received establishment inspection report (EIR) from the US Food and Drug administration (USFDA) for its Visakhapatnam facility. The inspection has been closed by the USFDA, the generic injectables maker said in its regulatory filing on November 8.
The US federal agency had inspected the company's Vizag unit from July 20 to July 28 this year, Gland Pharma said.
"This is to inform you that following the ‘Good Manufacturing Practice (GMP) Inspection’ by US FDA at the company's VSEZ Sterile Oncology Facility at Visakhapatnam between 20th July, 2023 and 28 th July, 2023; the company has received Establishment Inspection Report (EIR) from the US FDA indicating closure of the inspection," the drugmaker said.