GLAND : USFDA ISSUES 4 FORM 483 OBSERVATIONS AT DUNDIGAL FORMULATION FACILITY

• USFDA concluded an unannounced cGMP inspection at the Dundigal formulation facility between October 12 and October 23, 2026 • Inspection closed with four Form 483 observations, which the company said are procedural in nature • Observations are neither repeated observations nor related to data integrity • Corrective and preventive actions will be submitted to the USFDA within the stipulated period • Company stated no quantifiable impact on financial or operational activities

Gland Pharma Limited

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