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Aurobindo Pharma's Hyderabad API Unit Faces USFDA Inspection with Two Observations

USFDA Inspection Concludes at Aurobindo Pharma's Subsidiary Facility

Aurobindo Pharma announced on Tuesday that the US Food and Drug Administration (USFDA) has completed an inspection of a manufacturing facility owned by its subsidiary, Apitoria Pharma Pvt Ltd, with two observations.

Aurobindo arm Apitoria's API unit in Hyderabad gets 2 USFDA observations

The inspected facility, known as Unit-V, is located at Pashamylaram village in Patancheru mandal of Sanga Reddy district in Telangana and specializes in the production of active pharmaceutical ingredients (API). The inspection took place between December 9-17, 2022.

Procedural Observations to be Addressed

Aurobindo Pharma clarified in a regulatory filing that the observations made by the USFDA are procedural in nature and will be responded to within the stipulated time. Apitoria Pharma is a wholly-owned subsidiary of Aurobindo Pharma.

The company's stock experienced a 2.5% decline, closing at Rs 1213.45 on the Bombay Stock Exchange, compared to the previous day's closing of Rs 1245.