Gland Pharma has received Establishment Inspection Report (EIR) from the USFDA indicating closure of the inspection, following the Pre-Approval Inspection (PAI) for seven products and Good Manufacturing Practice (GMP) Inspection by USFDA at the Company’s Pashamylaram Facility at Hyderabad between June 15, 2023 and June 27, 2023.
Gland Pharma develops, manufactures and markets complex injectables. The company sells its products primarily under a business-to-business model in many countries.