Gland Pharma’s subsidiary Cenexi gets 11 observations from French regulator, operations unaffected
Published on 04/06/2025 09:02 PM
Gland Pharma’s subsidiary Cenexi gets 11 observations from French regulator, operations unaffectedGland Pharma confirmed that the observations will not disrupt manufacturing operations at the Fontenay site. Shares of Gland Pharma Ltd ended at ₹1,623.70, up by ₹29.90, or 1.88%, on the BSE.By Jomy Jos Pullokaran June 4, 2025, 9:02:10 PM IST (Published)2 Min ReadGland Pharma Ltd on Wednesday (June 4) said that its material subsidiary, Cenexi, has 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.
"...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.
Also Read: Gland Pharma shares gain on securing USFDA nod for blood pressure treatment drug
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.
Also Read: Gland Pharma shares have 'value', 23% upside potential despite poor execution, analyst says
Shares of Gland Pharma Ltd ended at ₹1,623.70, up by ₹29.90, or 1.88%, on the BSE.Continue Reading(Edited by : Shoma Bhattacharjee)Check out our in-depth Market Coverage, Business News & get real-time Stock Market Updates on CNBC-TV18. Also, Watch our channels CNBC-TV18, CNBC Awaaz and CNBC Bajar Live on-the-go!TagsGland Pharmashare market today