Aurobindo Pharma (APL) has received an alert warning from the US drug regulator for not meeting the compliance at one of its units in Hyderabad. The US Food and Drug Administration (FDA) has raised concerns on APL?s Unit VI and banned shipment from this unit, which manufactures cephalosporins.
Speaking to FE from the US, PV Ramprasad Reddy, chairman, said the company would be approaching the FDA in the next three to four days to understand the gravity of the situation.
?The total impact due to the proposed ban is expected to be around $26 million. However, we are yet to get a clarity on the situation,? Reddy said.
?We are trying to understand if the ban is for oral as well as injectables,? he said, adding cephalosporins contributes to about 10% of total business.
In its clarification, the company said that the cephalosporin facility, Unit VI, was audited by the USFDA in the month of December 2010. The company has sent the compliance report to FDA, which is under review.
?Subsequent to the audit findings, the FDA has imposed an import alert on their website for detention on APL Unit VI products. APL is trying to establish contact with FDA to understand the correct interpretation of such an alert on whether it relates only for sterile products and/or oral products manufactured at Unit VI,? the company said.
?We would ascertain the scope of this import ban alert and request the FDA for a face-to-face meeting at the earliest and present the facts with a view to comply with all regulations and bring the unit back to active operations at the earliest. Until then, it will impact shipments from Unit VI to the US market,? Reddy said.
Aurobindo Pharma is a dominant player in the cephalosporins and caters to all leading players in the world. It currently offers the world?s largest product portfolio with over 20 different cephalosporins.