Gland Pharma Visakhapatnam facility gets USFDA EIR
Telangana: Gland Pharma has recently announced that the Company has received Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) indicating the closure of the inspection at VSEZ Sterile Oncology Facility at Visakhapatnam.
USFDA had inspected the facility between 20 th July, 2023 and 28 th July, 2023.
"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 20 th July, 2023 and 28 th July, 2023; the Company has received Establishment Inspection Report (EIR) from the US FDA indicating closure of the inspection," Gland Pharma stated in a BSE filing.
Read also: USFDA concludes inspection at Gland Pharma Visakhapatnam facility with zero 483 observations
Gland Pharma, a generic injectable-focused pharmaceutical company, was established in 1978 in Hyderabad. The Company is present in sterile injectables, oncology and ophthalmic segments, and focuses on complex injectables including NCE-1s, First-to-File products and 505(b)(2) filings. Its products are currently delivered via liquid vials, lyophilized vials, pre-filled syringes, ampoules, bags and drops; and its efforts are underway to augment additional manufacturing capabilities in complex injectables such as peptides, long-acting injectables, suspensions and hormonal products. Gland is also in the process of including new delivery systems such as pens and cartridges into its product portfolio.
Read also: Gland Pharma gets USFDA EIR for Pashamylaram Facility
