Gland Pharma has received Establishment Inspection Report (EIR) from the USFDA for its Dundigal facility at Hyderabad.
USFDA has conducted inspection for Good Manufacturing Practices (GMP) at said facility between July 22, 2024 and July 25, 2024. The inspection was concluded with two 483 Observations.
Gland Pharma develops, manufactures and markets complex injectables. The company sells its products primarily under a business-to-business model in many countries.