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 conducted a good manufacturing practice (GMP) inspection at the company’s Dundigal facility from July 3-14. The inspection concluded with issue of one Form 483 observation, the company said 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 said.
The company’s shares closed 2.90% higher at ₹1,137.20 each on the BSE.
