Gland Pharma has announced that it has received the Establishment Inspection Report (EIR) from the US FDA for its sterile API manufacturing facility located at JNPC, Visakhapatnam. This follows the successful completion of the Pre-Approval Inspection (PAI) conducted between February 19 and February 25, 2025.
The receipt of the EIR indicates the closure of the inspection, signaling that the facility complies with the US FDA’s regulatory requirements. This development marks a positive step forward for Gland Pharma’s US operations and reinforces its commitment to maintaining high standards of quality and compliance.