Aurobindo Pharma arm’s API unit gets U.S. FDA observations

Aurobindo Pharma subsidiary Apitoria Pharma’s active pharmaceutical ingredients manufacturing facility near Hyderabad has been issued two observations by the U.S. Food and Drug Administration (US FDA) after an inspection.

The U.S. FDA had inspected Unit-V, the API facility, of Apitoria Pharma in Patancheru Mandal, Sanga Reddy district, from December 9-17. The inspection closed with two observations. The observations are procedural in nature and will be responded to within the stipulated time, Aurobindo Pharma said in a filing on Tuesday. The parent company’s shares closed 2.53% lower at ₹1,213.45 each on the BSE.