The United States Food and Drug Administration (USFDA) has conducted a Pre-Approval Inspection (PAI) at Unit-I & III, Formulation manufacturing facility, of APL Healthcare, a wholly owned subsidiary of Aurobindo Pharma, situated at Telangana, from November 13 to 17, 2023. The inspection closed with zero observations and a classification of ‘No Action Indicated’ (NAI).
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.