Gland Pharma Limited has informed the Exchange about Receipt of EIR from US FDA for Company s JNPC Facility, Visakhapatnam
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Gland Pharma has received an Establishment Inspection Report (EIR) from the US FDA confirming the closure of the Pre-approval Inspection (PAI) conducted at its JNPC facility in Visakhapatnam between February 19 and February 25, 2025. The inspection was related to Sterile APIs (Active Pharmaceutical Ingredients). An EIR with closure status means the FDA has completed its review of the inspection and found the facility acceptable, with no outstanding Form 483 observations requiring further action. This is a follow-up to the company's earlier intimation dated February 25, 2025.
This is a positive development for Gland Pharma shareholders, as successful closure of the FDA inspection paves the way for potential approvals and commercial supply of sterile APIs from this facility to the US market. It removes regulatory uncertainty and supports the company's export business outlook.