Aurobindo to lose $2 mn a month due to USFDA ban

Aurobindo Pharma that has suffered a setback in its US exports after USFDA's import ban on products manufactured at its Cephalosporin facility at Chitkul village near here, said it may incur a revenue loss of up to $2 million per month until the issue is resolved.

"Our sales may be affected by $2 million per month as long as this issue is not resolved. This is common for any pharma company. We cannot predict how long it will take (to resolve the issue). It may take some time. As per our technical advisor's estimations we can say it may take some weeks to resolve the issue," APL Managing Director Nityananda Reddy told PTI.

He said the products from this unit, which are under transit will also be affected with the directive of US regulator. According to Reddy, they have not received any official communication from the United States Food and Drug Administration (USFDA) in this regard.

The USFDA officials audited the facility in December last year and the company has sent the compliance report to USFDA, which is under review.

"Subsequent to the audit findings USFDA has imposed an import alert on their website for detention on APL Unit VI products," the alert said on February 7.

APL is trying to establish contact with USFDA to understand the correct interpretation of such an alert on whether it relates only to sterile products and/or oral products manufactured at Unit VI, the company said.