Aurobindo Pharma has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its manufacturing facility at Pydibhimavaram in Andhra Pradesh.
The company's Unit XI at Pydibhimavaram is an API non-antibiotic manufacturing facility. It was inspected by the USFDA in February 2019 and issued a warning letter in June 2019. It was inspected further by the USFDA from July 25 to August 2, 2022 and issued a Form 483 with three observations.
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.
