An active pharmaceutical ingredient (API) manufacturing facility of Aurobindo Pharma subsidiary Apitoria Pharma near Hyderabad has been issued 10 observations by the U.S. Food and Drug Administration on completion of an inspection.
The U.S. FDA had inspected the API manufacturing facility (Unit-II) of Apitoria Pharma in Sanga Reddy district from September 23-27. The inspection closed with 10 observations. The observations are of procedural in nature and will be responded to within the stipulated time, Auronbindo Pharma said in a filing on Monday. The parent company’s shares declined 3.24% to close at ₹1,460.90 apiece on the BSE.
Aurobindo Pharma informed the exchange that the U.S. FDA audit concluded at 8 p.m. on September 27. “Because of non-availability of senior technical team to review the nature of observations, there is a delay in intimation,” it said.
Published - September 30, 2024 10:15 pm IST
