The United States Food and Drug Administration (USFDA) has inspected Aurobindo Pharma’s wholly owned subsidiary -- Apitoria Pharma’s API manufacturing facility - Unit-V situated at Sangareddy district in Telangana. The inspection was conducted from December 1 to December 12, 2025. The USFDA has issued ‘Form 483’ with total of 3 observations which are procedural in nature.
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.
