The United States Food and Drug Administration (US FDA) has concluded a good manufacturing practices inspection at the company's Dundigal Facility at Hyderabad between July 3, 2023 to July 14, 2023, Gland Pharma announced through an exchange filing.
The inspection that was completed on Friday was concluded with One (1) 483 Observation. The corrective and preventive actions for this observation will be submitted to the US FDA within the stipulated period, the company said in the regulatory filing.
According to the company, the observation issued is neither a repeated observation nor is it related to data integration.
Gland Pharma shares
The shares of Gland Pharma on Friday afternoon at 12:38 pm IST were trading at Rs 1,139.55, up by 3.16 per cent.