Gland Pharma Limited has informed the Exchange about Update on the ANSM Inspection at Cenexi s Fontenay Manufacturing Facility
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French drug regulator ANSM has issued its final report on the Good Manufacturing Practices (GMP) inspection of Cenexi's Fontenay facility (a material subsidiary of Gland Pharma), conducted in December 2024, citing 11 observations. Cenexi has submitted a Corrective and Preventive Action Plan (CAPA) with measures to be implemented over 3-12 months, which has been accepted by ANSM. The company has confirmed there will be no disruption to manufacturing operations at the facility. This is a follow-up to an earlier intimation dated December 25, 2024.
The accepted CAPA and confirmation of no manufacturing disruption are positive signals for shareholders, though the 11 observations and 3-12 month remediation timeline warrant monitoring. Short-term stock impact is likely limited, but any escalation or supply disruption in future updates could affect sentiment.