U.S. FDA issues observation to Aurobindo Pharma arm’s API unit

An active pharmaceutical ingredient (API) manufacturing facility of Aurobindo Pharma subsidiary Apitoria Pharma near Hyderabad has been issued an observation by the U.S. Food and Drug Administration (U.S. FDA).

Apitoria Pharma’s Unit-II, an API manufacturing facility, in Sangareddy district, was inspected from September 7-15. “The inspection concluded with one observation, which is procedural in nature and we will respond to the U.S. FDA within the stipulated timeline,” Aurobindo Pharma said in a filing on Tuesday.