Gland Pharma has received Establishment Inspection Report (EIR) from the USFDA indicating closure of the inspection at Pashamylaram Facility, Hyderabad. The Pre-Market Inspection covering USFDA’s Quality System/Current Good Manufacturing Practice regulations for Medical Devices (21 CFR Part 820) by USFDA conducted at the Company’s Pashamylaram Facility at Hyderabad between August 23, 2023 and August 26, 2023.
Gland Pharma develops, manufactures and markets complex injectables. The company sells its products primarily under a business-to-business model in many countries.
