Shares of Gland Pharma Ltd rose 2% to touch a day’s high of Rs 1,800 on 24th June. The rise came after the company announced it had received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its Visakhapatnam facility. This marked the closure of the inspection.

The USFDA conducted a pre-approval inspection for sterile APIs at Gland Pharma’s JNPC facility in Visakhapatnam. This inspection took place between the 19th and 25th of February, 2025.

Earlier this month, Gland Pharma received USFDA approval for Angiotensin II Acetate injection (2.5 mg/mL). It is used to treat low blood pressure in adults with septic or distributive shock. This is the generic version of GIAPREZA by La Jolla Pharma.

Separately, Gland Pharma’s material subsidiary, Cenexi, received a final inspection report from France’s drug regulator (ANSM) for its Fontenay facility. The inspection, conducted in December 2024, yielded 11 observations related to Good Manufacturing Practices (GMP).

Cenexi responded with a corrective and preventive action (CAPA) plan. This plan outlines steps to be taken over the next three to 12 months. The French regulator has accepted the plan, and Gland Pharma confirmed that operations at the site will continue without disruption.

At 2:26 PM, the shares of Gland Pharma were trading 1.35% higher at Rs 1,767.90 on NSE.

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