Date: November 11, 2026
Regulatory Compliance Update
US FDA Inspection Outcome
- The United States Food and Drug Administration (US FDA) inspected Unit-II, an API manufacturing facility of Apitoria Pharma Private Limited
- Apitoria Pharma Private Limited is a wholly owned subsidiary of Aurobindo Pharma Limited
- Facility location: Gaddapotharam, Industrial Development Area – Kazipally Industrial Area, Jinnaram Mandal, Sangareddy District, 502319, Telangana
- Inspection period: September 7th to September 15th, 2026
Establishment Inspection Report (EIR) Classification
- The facility received an Establishment Inspection Report (EIR) classifying it as "Voluntary Action Indicated" (VAI)
- The US FDA concluded that the inspection is closed under 21 CFR 20.64(d)(3)