“…this is to inform you that the Agence nationale de sécurité du médicament et des produits de santé (ANSM), France, has issued its final report citing 11 (Eleven) observations, in pursuance of the Good Manufacturing Practices (GMP) inspection of Cenexi’s Fontenay Manufacturing Facility (‘Facility’) (material subsidiary of Gland Pharma Limited) between 9th December to 19th December, 2024,” according to a stock exchange filing.
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The inspection was conducted between December 9-19, 2024. In response, Cenexi has submitted a corrective and preventive action (CAPA) plan, which includes a range of measures to be implemented over a 3 to 12-month period, depending on the nature of each observation. The action plan has been accepted by ANSM.
Gland Pharma confirmed that the observations will not disrupt manufacturing operations at the Fontenay site. The company stated that Cenexi remains committed to addressing the observations in close coordination with ANSM and will continue to keep the exchanges informed of further developments.
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Shares of Gland Pharma Ltd ended at ₹1,623.70, up by ₹29.90, or 1.88%, on the BSE.
(Edited by : Shoma Bhattacharjee)
