Aurobindo Pharma Unit 1 gets US FDA observations

The US Food and Drug Administration (USFDA) has issued Form 483 observations against Unit I of Aurobindo Pharma Limited in Hyderabad. The plant is used for manufacturing of active pharmaceutical ingredients (APIs), which contribute little over 20 percent of the company's total revenues.

Confirming the development, a company official said they had received a minor observation from the US drug regulator in the month of October and it was not going to have any material impact going forward. Earlier in February, Aurobindo's Unit VII in Mahaboobnagar district in Telangana received some Form 483 observations from the US FDA inspectors. Companies receiving Form 483 observations must respond to the US drug regulator with remedial action plan followed by its implementation.

Aurobindo scrip fell Rs 26.10 or by 3.73 percent at Rs 673.45 on Bombay Stock Exchange on Tuesday.