United States Food and Drug Administration (USFDA) has concluded Pre-approval inspection (PAI) for Sterile APIs at Gland Pharma’s facility at JNPC, Visakhapatnam. The inspection was conducted from February 19, 2025 to February 25, 2025.
The said inspection was concluded with three 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. 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.
