Gland Pharma Says Cenexi’s Compliance Measures Cleared By French Regulator

Gland Pharma Ltd said its subsidiary Cenexi has completed a corrective and preventive action plan addressing observations from France’s National Agency for the Safety of Medicines and Health Products for its Fontenay manufacturing facility.

The measures, taken over a 3–12 month period, have been accepted by the regulator, the company said in an exchange filing.

The French agency had issued 10 observations following an inspection conducted between December 9 and December 19, but no disruption is expected in manufacturing operations as a result of the final inspection report.