The United States Food and Drug Administration U.S. (FDA) has issued seven observations to an injectable facility of drugmaker Aurobindo Pharma’s step-down subsidiary Eugia SEZ near Hyderabad.
The observations were issued on completion of an inspection of the injectable facility of Eugia SEZ in Jadcherla by the regulator from February 19-29. “The observations are procedural in nature and will be responded to within the stipulated time,” Aurobindo Pharma said in a filing on February 29.
Restarts production
In another filing, the drugmaker said subsidiary Eugia Pharma Specialities had restarted production in its terminally sterilised product lines at Unit-III. It had temporarily stopped the production to address some of the observations of the U.S. FDA during an inspection that concluded on February 2. “We expect to start the production in the aseptic lines of the facility in March 2024,” Aurobindo said.
Following the inspection, Aurobindo Pharma had said that the formulation manufacturing facility of Eugia Pharma Specialities in Hyderabad was issued nine observations by the regulator. “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,” it had then said.
