USFDA inspection: Gland Pharma gets EIR for Dundigal Facility
Hyderabad: Gland Pharma has announced that the Company has received Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA) indicating closure of the inspection at its Dundigal Facility at Hyderabad.
This follows an inspection for Good Manufacturing Practices (GMP) conducted between 22nd July, 2024 and 25th July. In July, the facility received two 483 Observations from the USFDA.
"In continuation to our intimation dated July 25, 2024; this is to inform you that following the Inspection for Good Manufacturing Practices (GMP) by US FDA at the Company’s Dundigal Facility at Hyderabad between 22nd July, 2024 and 25th July, 2024; the Company has received Establishment Inspection Report (EIR) from the US FDA indicating closure of the inspection," the Company stated in a BSE filing.
Read also: Gland Pharma gets 2 USFDA observations for Dundigal facility
Gland Pharma was established in 1978 in Hyderabad and has grown over the years from a contract manufacturer of small-volume liquid parenteral products to become growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets. It operates primarily under a business-to-business (B2B) model and develops, manufactures, and markets sterile injectables. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions.
Read also: Gland Pharma arm Fontenay facility gets 10 observations from France drug regulator
