Shares of Gland Pharma Ltd rose 2% to the touch a day’s excessive of Rs 1,800 on twenty fourth June. The rise got here after the corporate introduced it had obtained an Institution Inspection Report (EIR) from the US Meals and Drug Administration (USFDA) for its Visakhapatnam facility. This marked the closure of the inspection.
The USFDA carried out a pre-approval inspection for sterile APIs at Gland Pharma’s JNPC facility in Visakhapatnam. This inspection befell between the nineteenth and twenty fifth of February, 2025.
Earlier this month, Gland Pharma obtained USFDA approval for Angiotensin II Acetate injection (2.5 mg/mL). It’s used to deal with low blood strain in adults with septic or distributive shock. That is the generic model of GIAPREZA by La Jolla Pharma.
Individually, Gland Pharma’s materials subsidiary, Cenexi, obtained a last inspection report from France’s drug regulator (ANSM) for its Fontenay facility. The inspection, carried out in December 2024, yielded 11 observations associated to Good Manufacturing Practices (GMP).
Cenexi responded with a corrective and preventive motion (CAPA) plan. This plan outlines steps to be taken over the subsequent three to 12 months. The French regulator has accepted the plan, and Gland Pharma confirmed that operations on the website will proceed with out disruption.
At 2:26 PM, the shares of Gland Pharma had been buying and selling 1.35% greater at Rs 1,767.90 on NSE.
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