The United States Food and Drug Administration (USFDA) has completed inspection at Aurobindo Pharma’s wholly owned subsidiary -- Apitoria Pharma’s Unit-II, an API manufacturing facility situated at Telangana. The USFDA had conducted an inspection from September 23, 2024 to September 27, 2024 at this facility.
The inspection closed with 10 observations. The observations are of procedural in nature and will be responded to within the stipulated time.
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.
