The US Food and Drug Administration (USFDA) has reportedly issued Form 483 observations against Unit I of Aurobindo Pharma in Hyderabad, India. The plant is used for manufacturing of active pharmaceutical ingredients (APIs), which contribute little over 20% of the company's total revenues.
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.
