Aurobindo Pharma arm’s API unit gets 3 U.S. FDA observations

An active pharmaceutical ingredients (API) manufacturing facility of Aurobindo Pharma subsidiary Apitoria Pharma in Hyderabad has received three observations from the U.S. Food and Drug Administration.

The U.S. FDA inspected Unit-V, an API manufacturing facility of subsidiary Apitoria Pharma in Pashamylaram village, Sangareddy district from December 1-12. At the end of the inspection, a Form 483 was issued with three observations. Aurobindo Pharma said the observations are procedural in nature and the company will respond to the U.S. FDA within the stipulated timelines.