A formulation manufacturing facility of Aurobindo Pharma subsidiary Eugia Pharma Specialities in Hyderabad has been issued 9 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 stated in a submitting on Friday.
The drugmaker stated it’ll reply to the observations throughout 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 stated.
Shares of the corporate closed lower than 1% decrease at ₹1,066.35 apiece on the BSE.
