Further to its intimation dated August 26, 2023; Gland Pharma has informed 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.
The above information is a part of company’s filings submitted to BSE.
