A formulation manufacturing facility of Aurobindo Pharma subsidiary Eugia Pharma Specialities in Hyderabad has been issued nine observations by the United States Food and Drug Administration.
“The U.S. FDA inspected Unit-III, a formulation manufacturing facility of Eugia Pharma Specialities, a wholly owned subsidiary, in Pashamylaram, Sangareddy district of Telangana from January 22 to February 2. The inspection closed with 9 observations,” Aurobindo Pharma said in a filing on Friday.
The drugmaker said it will respond to the observations within the stipulated time. “The company has decided to temporarily stop manufacturing on certain lines to conduct holistic investigation and corresponding partial distribution thereto… already started working with the regulatory authority / third party consultants to accelerate the process and re-start production on those lines at the earliest. At this point in time, we don’t foresee any material impact on the business,” Aurobindo said.
Shares of the company closed less than 1% lower at ₹1,066.35 apiece on the BSE.
