Drugmaker Gland Pharma’s facility in Hyderabad has been issued an observation by the U.S. Food and Drug Administration (U.S. FDA).
The U.S FDA performed an excellent manufacturing observe (GMP) inspection on the firm’s Dundigal facility from July 3-14. The inspection concluded with concern of 1 Form 483 observation, the corporate stated on Friday.
“The corrective and preventive actions for this observation will be submitted to the U.S. FDA within the stipulated period. The observation issued is neither a repeated observation nor related to data integrity,” Gland Pharma stated.
The firm’s shares closed 2.90% larger at ₹1,137.20 every on the BSE.
