Aurobindo Pharma gets Form 483 from US FDA after Bachupally inspection
Aurobindo confirmed the US Food and Drug Administration (FDA) had inspected its facility – known as Unit III – in a filing on the Bombay Stock Exchange (BSE) today.
The firm said the six observations related to “procedural improvements,” but did not provide additional detail.
Aurobindo stressed that none of the US regulator’s concerns relate to “data integrity” issued.
According to the firm's website, the Unit III facility makes a variety of oral solid dosage forms, including anti-retroviral drugs.
The sale of finished drugs - formulations - in the US accounted for 55% of Aurobindo's INR3,747cr ($556mn) revenue in fiscal 2016.
Also according to Aurobindo's annual report, as of March 2016 the Unit III facility is listed as the manufacturing site in 93 of the firm's approved abbreviated new drug applications (ANDAs).
