The pre-approved inspection for Sterile active pharmaceutical ingredients (APIs) at the company’s JNPC, Visakhapatnam facility was conducted between February 19 and February 25, 2025.
Earlier this month,
Gland Pharma secured USFDA approval for Angiotensin II Acetate injection, 2.5 mg/mL, which is used for treating blood pressure in adults with septic or other distributive shock. The approved product is the generic equivalent of GIAPREZA, a drug developed by La Jolla Pharma LLC.
Earlier this month, the company’s material subsidiary Cenexi also received a final inspection report from France’s drug regulator Agence nationale de sécurité du médicament et des produits de santé (ANSM), citing 11 observations related to Good Manufacturing Practices (GMP) compliance at its Fontenay manufacturing facility.
The inspection was conducted between December 9 and December 19, 2024. In response, Cenexi submitted a corrective and preventive action (CAPA) plan, which included a range of measures to be implemented over a three to 12-month period, depending on the nature of each observation. The regulator accepted the action plan. Gland Pharma said the observations would not disrupt the manufacturing operations at the site.
Gland Pharma shares gained 3.2% to hit an intraday high of ₹1,800 per share on Tuesday, June 24. The stock was up 1.78% at ₹1,775.5 apiece at 10.55 am. It has gained 16.3% in the past month.
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