Aurobindo subsidiary completes FDA inspection with procedural observations

Aurobindo Pharma Limited announced today the completion of a US FDA inspection at Unit-I of Apitoria Pharma Private Limited, its wholly-owned subsidiary. The inspection, conducted at the API manufacturing facility in Borpatla Village, Telangana, from August 21 to August 29, 2025, resulted in a 'Form 483' with five observations.

The company stated that all five observations were procedural and did not indicate any data integrity issues. Apitoria Pharma Private Limited plans to respond to the US FDA within stipulated timelines. Aurobindo Pharma reiterated its commitment to maintaining high-quality manufacturing standards across its global facilities.

The company confirmed there is no impact on its financials or operations due to this inspection outcome.