Gland Pharma Ltd has announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its JNPC facility in Visakhapatnam.
The EIR follows the successful completion of a Pre-Approval Inspection (PAI) conducted by the US FDA for sterile Active Pharmaceutical Ingredients (APIs) at the site, which took place from February 19 to February 25, 2025. The receipt of the EIR signifies the formal closure of the inspection process.
This update comes in continuation of the company’s earlier announcement made on February 25, 2025.