Aurobindo Pharma Ltd will continue to suffer revenue loss due to a ban of US Food and Drug Administration on its Unit VI for six more months.
The Hyderabad-based company was expecting the inspectors from the US regulator to audit its facility between June-July this year, according to Mr Ramprasad Reddy, Chairman, Aurobindo Pharma Ltd.
Exactly one year ago, the USFDA had banned the import of products manufactured from Unit VI of its manufacturing facility on the outskirts of Hyderabad, following an inspection it had conducted in December 2010.
Aurobindo manufactures Cephalosporin oral and injectable products at the unit.
Responding to a question on steps taken so far to get the facility cleared by the USFDA in the earnings conference call last week, Mr Reddy said “We have a lot to streamline. The third-party consultants are already in the plant as requested by the FDA.''
Unit III inspection
Pfizer, with which Aurobindo has a tie-up, had given lot of inputs and training on the issue, he added.
As for the Unit III, which is also facing an alert, Mr Reddy said the USFDA would inspect it between February 29 and March 4.
The year-long ban on unit VI has been showing adverse impact on the revenue. The US formulations sales have been flat which is impacted by the USFDA import alert during the third quarter of the current fiscal, the company said. The loss of sales for each quarter due to ban could be at approximately $10 million.