Aurobindo Hyderabad plant in regulatory trouble, share price falls 8%

The US Food and Drug Administration issued Form 483 with 14 observations to the company following the completion of inspection from November 4-14.

Aurobindo Pharma Limited scrip fell more than 8 per cent on Bombay Stock Exchange on Thursday reacting to the latest adverse inspectional outcome at the company's Unit 4, Injectable formulations facility at Pashamylaram in Hyderabad.

The US Food and Drug Administration (USFDA) issued Form 483 with 14 observations to the company following the completion of inspection from November 4-14.

This is Aurobindo's third facility to receive critical observations from the US drug regulator in this month and the sixth facility that failed to pass the US FDA inspection since June this year. The company was issued a Warning Letter for one of its manufacturing facilities earlier this year.

The company's share traded 8.90 per cent lower at Rs 395.50 during the afternoon trade on Thursday following the development. In a late evening filing the company admitted that they were issued a Form 483 with 14 observations for the Pashamylaram formulations facility.

However, the company maintained that none of these observations were related to data integrity issues and will respond to the US FDA within the stipulated time-line to address the latter's concerns regarding the same.