United States Food and Drug Administration (USFDA) has concluded the surprise inspection at Gland Pharma’s Dundigal facility at Hyderabad. USFDA has conducted surprise inspection for Good Manufacturing Practices (GMP) between July 22, 2024 and July 25, 2024.
The inspection was concluded with two 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. The observations issued are neither repeated observations 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.
