Aurobindo Pharma is the latest Indian drugmaker to suffer under an FDA ban of its products. After an FDA inspection in December, the company's facility near Hyderabad is now under an import alert, meaning the cephalosporin drugs produced there can't be sold in the U.S. Aurobindo shares tanked on the news, and Goldman Sachs downgraded the stock.
The facility contributes 5 percent to 6 percent to Aurobindo's total sales, analysts said. The company expects it will lose up to $2 million in sales per month because of the ban. One question that Aurobindo is trying to answer is whether the ban will apply only to injectable cephalosporins or to oral drugs as well.
"We cannot predict how long it will take (to resolve the issue)," Managing Director Nityananda Reddy said. "It may take some time. As per our technical advisor's estimations we can say it may take some weeks to resolve the issue."
Ranbaxy Laboratories is still under an import alert more than a year after the FDA seized 30 products on manufacturing violations. Claris LifeSciences also was subject to an import ban because some of its injectable drugs were contaminated with bacteria and fungus.