Aurobindo Pharma halts production at Eugia’s Unit-III facility after 9 USFDA observations, ET HealthWorld

Hyderabad: Aurobindo Pharma is temporarily stopping manufacturing on certain lines of the Pashamylaram formulations facility of its wholly-owned subsidiary, Eugia Pharma Specialities’, at Pashamylaram in Hyderabad after the facility received nine US Food & Drug Administration (USFDA) observations.

The observations were issued on Friday after the US drugs watchdog wrapped up its inspection of the Eugia facility, Unit-III, that is located on the outskirts of Hyderabad. The inspection was conducted by the US regulatory authority from Jan 22 to Feb 2, 2024.

“The inspection closed with 9 observations. The company has decided to temporarily stop manufacturing on certain lines to conduct holistic investigation and corresponding partial distribution thereto,” Aurobindo Pharma said in a regulatory filing with the bourses on Friday.

“The company has already started working with the regulatory authority and third party consultants to accelerate the process and re-start production on those lines at the earliest,” the company said.

Aurobindo said it will also be responding to these USFDA observations within the stipulated time and does not foresee any material impact on its business at this point in time.

The company remains committed to work closely with the US FDA and continues to enhance its compliance on an ongoing basis, Aurobindo added.

  • Published On Feb 4, 2024 at 06:04 AM IST

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