Gland Pharma has received Establishment Inspection Report (EIR) from United States Food and Drug Administration (USFDA) indicating closure of Pre-approval inspection (PAI) for Sterile APIs at JNPC, Visakhapatnam facility. The said inspection was conducted between February 19, 2025 and February 25, 2025.
Gland Pharma develops, manufactures and markets complex injectables. The company sells its products primarily under a business-to-business model in many countries.