US FDA lifts import alert on Aurobindo facility

The US Food and Drug Administration (FDA) has lifted an import alert for non-sterile products manufactured at a Hyderabad facility of Aurobindo Pharma.

“The FDA, as per their website, update has lifted the import alert for non-sterile products manufactured at Unit – VI cephalosporin facility,” Aurobindo said in a statement.

The drug firm makes Cephalosporins, a class of antibiotics indicated for the treatment of infections caused by bacteria, at the unit.

It supplies nine products from the unit to the US market and till the import alert the unit was contributing about $33 million (Rs 180 crore) in revenues.

Following the alert, exports from the unit to the US were completely grounded.

“The audit for the unit was conducted in December 2010 by the FDA. There were some observations and an import alert was issued. However, a re-audit was done recently and the unit has been cleared after the company complied with the observations made the regulator,” a source associated with the company said.

Apart from the US, the unit serves other markets, too.

“It’s not just about the absolute revenue the unit earns from the US. There are other markets that depend on the FDA certification for importing products. Even that will be lost if there is an FDA alert,” the source said.

In fact, even after the FDA lifting the alert, sources said, the company will have to stretch an extra mile to gain the lost share.

“The competition would have gained from Aurobindo’s difficulties. After the alert is lifted, the market does not come back immediately. It is going to be a slow process. But it is important to keep the company’s track record clean,” he said.

@ramanakv