Cenexi Fontenay Manufacturing Facility Receives Observations Post GMP Inspection by ANSM, France.

Cenexi Fontenay Manufacturing Facility a material subsidiary of Gland Pharma Limited recently underwent a Good Manufacturing Practices (GMP) inspection by the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), France. The inspection was conducted over a ten-day period from December 9 to December 19, 2024.

Key Outcome of the Inspection

Following the inspection the facility received an official notification on December 24, 2024 highlighting 10 observations. These observations typically related to adherence to GMP standards are aimed at improving compliance and maintaining the highest standards of pharmaceutical manufacturing.

Commitment to Compliance

Cenexi has expressed its commitment to addressing the observations in a thorough and timely manner. The company is working closely with ANSM to ensure all concerns are resolved and that the facility remains compliant with GMP requirements.

Focus on Quality and Continuous Improvement

The GMP inspection underscores the importance of adhering to international quality standards in pharmaceutical manufacturing. Cenexi’s proactive approach to addressing these observations reflects its dedication to upholding quality and operational excellence.

Looking Ahead

The resolution of these observations will further strengthen Cenexi’s standing as a reliable player in the global pharmaceutical industry. Gland Pharma Limited and its subsidiary remain focused on delivering high-quality products while adhering to regulatory requirements.

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