Aurobindo Pharma subsidiary receives 5 US FDA observations at Unit-IV

Aurobindo Pharma Limited announced the completion of a US FDA inspection at Unit-IV of APL Healthcare Limited, its wholly owned subsidiary. The inspection took place from December 8 to December 17, 2025, at the facility located in Palchur village, Naidupeta Mandal, SPSR Nellore District, Andhra Pradesh.

Upon conclusion, a 'Form 483' was issued with five observations, which Aurobindo Pharma characterized as procedural in nature. The company stated its intention to respond to the US FDA within stipulated timelines and reaffirmed its commitment to maintaining high-quality manufacturing standards across all its global facilities.

Aurobindo Pharma has confirmed that this development, including the issuance of the Form 483, is not expected to have any impact on the financial or operational activities of the facility. The company will continue to inform stock exchanges of any further information related to the inspection.