Gland Pharma gets USFDA EIR for Pashamylaram facility
Telangana: Gland Pharma has received Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) indicating closure of the inspection for Good Manufacturing Practices (GMP) at the Company’s Pashamylaram Facility at Hyderabad.
The EIR follows an inspection conducted between 25th July, 2024 and 02nd August, 2024. In August, the facility got three 483 Observations from the USFDA.
Read also: Gland Pharma gets 3 USFDA observations for Pashamylaram facility
Medical Dialogues team had earlier reported that the Company had received EIR for Dundigal Facility at Hyderabad.
Read also: USFDA inspection: Gland Pharma gets EIR 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.
