The United States Food and Drug Administration (USFDA) has concluded an unannounced inspection on Current Good Manufacturing Practice (cGMP) at Gland Pharma’s formulation facility at Dundigal. The USFDA has conducted inspection from October 12, 2026 to October 23, 2026.
The said inspection was concluded with four (4) Form 483 Observations. These observations are procedural in nature. The corrective and preventive actions for these observations will be submitted to the USFDA within the stipulated period.
Gland Pharma develops, manufactures and markets complex injectables. The company sells its products primarily under a business-to-business model in many countries.
