Gland Pharma has received Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for manufacturing facility at Dundigal, Hyderabad. USFDA had conducted inspection at the said manufacturing facility from July 03, 2023 to July 14, 2023. The inspection was concluded with (1) 483 Observation.
Gland Pharma develops, manufactures and markets complex injectables. The company sells its products primarily under a business-to-business model in many countries.