Aurobindo Pharma unit receives 8 US FDA observations

Aurobindo Pharma Limited announced on September 5, 2025, the completion of a US Food and Drug Administration (FDA) inspection at its Unit-XII facility in Bachupally, Medchal Malkajgiri District, Telangana. The inspection, which covered both oral solids and injectable manufacturing units, took place from August 25 to September 5, 2025.

At the conclusion of the inspection, Aurobindo Pharma was issued a 'Form 483' with a total of eight observations. The company stated that all observations are procedural in nature and committed to responding to the US FDA within the stipulated timelines. Aurobindo Pharma also reaffirmed its dedication to maintaining high-quality manufacturing standards across its global facilities.

The company's disclosure confirmed that the action has no impact on its financial or operational activities. Aurobindo Pharma will keep stock exchanges informed of any future developments related to this matter.