Gland Pharma gets UFSDA EIR for Dundigal Facility
Hyderabad: Gland Pharma has received the Establishment Inspection Report (EIR) from the Office of Product Evaluation and Quality Center for Devices and Radiological Health, USFDA indicating closure of the inspection at the company's Dundigal Facility.
The facility was inspected from 22 August 2022 to 25 August 2022.
"Further to our intimation dated August 25, 2022; 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) at the Company’s Dundigal Facility at Hyderabad from 22nd August, 2022 to 25th August, 2022; the Company has received the Establishment Inspection Report (EIR) from the Office of Product Evaluation and Quality Center for Devices and Radiological Health, US FDA indicating closure of the inspection," the company stated in a BSE filing.
Read also: Gland Pharma Singapore arm to acquire Cenexi Group for over Rs 1000 crore
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.
Read also: Gland Pharma bags USFDA nod for Cangrelor for Injection
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