Gland Pharma’s subsidiary gets 11 observations for Fontenay manufacturing facility

05 Jun 2025 Evaluate

Agence nationale de securite du medicament et des produits de sante (ANSM), France, has issued its final report citing 11 observations, in pursuance of the Good Manufacturing Practices (GMP) inspection at Gland Pharma’s material subsidiary -- Cenexi’s Fontenay manufacturing facility between December 09 to December 19, 2024.

Cenexi has undertaken a Corrective and Preventive Action Plan, with various appropriate measures, within a period ranging from 3 -12 months (varies for each observation), and the same has been accepted by ANSM. There will be no disruption in the manufacturing operations due to this final inspection report. Cenexi is committed to working closely with the ANSM to address the Observations and will provide further updates to the Exchanges as they become available.

Gland Pharma develops, manufactures and markets complex injectables. The company sells its products primarily under a business-to-business model in many countries.

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