The U.S. Food and Drug Administration issued four Form 483 observations to Gland Pharma’s formulation facility in Dundigal near Hyderabad.
The procedural observations followed an unannounced inspection on current good manufacturing practice conducted between October 12 and 23.
Gland Pharma stated that the observations are neither repeat observations nor related to data integrity, while its shares closed 1.17% lower at ₹2,825.35 on the BSE.