Aurobindo Pharma’s wholly owned subsidiary -- Apitoria Pharma has received Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Unit-V, an API manufacturing facility situated at Telangana. The USFDA has classified the said facility as Voluntary Action Indicated (VAI) and this inspection is now closed.
The USFDA had conducted an inspection of the said facility from December 01 to December 12, 2025 and issued a ‘Form 483’ with 03 observations.
Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.
