United States Food and Drug Administration (USFDA) has conducted a Pre-Approval Inspection (PAI) at new injectable facility of Eugia US Manufacturing LLC, a step-down wholly owned subsidiary of Aurobindo Pharma, situated at East Windsor, New Jersey, USA from December 11 to December 22, 2023. The inspection closed with 10 observations. The observations are procedural in nature and will be responded to within the stipulated time. The plant is yet to start commercial operations.
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.
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