United States Food and Drug Administration (USFDA) has concluded Good Manufacturing Practice (GMP) Inspection at the Gland Pharma’s Dundigal Facility at Hyderabad between July 03, 2023 and July 14, 2023. The inspection was concluded with (1) 483 Observation.
The corrective and preventive actions for this observation will be submitted to the US FDA within the stipulated period. The observation issued is neither a repeated observation nor related to data integrity.
Gland Pharma develops, manufactures and markets complex injectables. The company sells its products primarily under a business-to-business model in many countries.
