Gland Pharma gets USFDA EIR for Pashamylaram facility
Hyderabad: Gland Pharma has recently announced that the Company has received an Establishment Inspection Report (EIR) from the US FDA indicating the closure of the inspection at the Company’s Pashamylaram Facility in Hyderabad.
The USFDA inspected the facility between 23rd August, 2023 and 26th August, 2023.
"Further to our intimation dated August 26, 2023; this is to inform you that following the Pre-Market Inspection covering US FDA’s Quality System/Current Good Manufacturing Practice regulations for Medical Devices (21 CFR Part 820) by US FDA at the Company’s Pashamylaram Facility at Hyderabad between 23rd August, 2023 and 26th August, 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.
Gland Pharma, a generic injectable-focused pharmaceutical company, was established in 1978 in Hyderabad. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions.
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