U.S. FDA issues warning letter to Aurobindo Pharma arm’s formulation unit
The U.S. Food and Drug Administration has issued a warning letter to a formulation manufacturing facility of Aurobindo Pharma’s subsidiary Eugia Pharma Specialities near Hyderabad.
The facility (Unit-III) had received Official Action Indicated (OAI) status from the the U.S. FDA in May. “Subsequent to the OAI, the unit has received a warning letter. There is no impact on the existing supplies to the U.S. markets,” the parent company said in a filing on Friday.
Aurobindo Pharma shares closed 1.11% lower at ₹1,502.30 each on the BSE. It had dropped to ₹1,422 apiece intra-day.
The company remains committed to work closely with the U.S. FDA and continues to enhance its compliance on an ongoing basis, it said. The regulator had inspected the formulation manufacturing facility, situated in Pashamylaram, Sangareddy district in Telangana, from January 22 to February 2.