US FDA removes import alert on Aurobindo Hydrabad plant

US FDA removes import alert on Aurobindo Hydrabad plantThe United States Food and Drug Administration (FDA) has removed an import alert on the products produced at the Hyderabad unit of Aurobindo Pharma.

The company cited FDA's website post to state that the Americna regulator has removed the import alert on non-sterile products manufactured at Unit, VI cephalosporin facility. Aurobindo Pharma manufactures Cephalosporins antibiotics, which are used to treat infections caused by bacteria at the unit in Hyderabad.

The company exports nine products produced at the unit to the US market and it generated about $33 million in revenues for the company till the alert was announced. The exports of the product to the US market were completely stopped after the alert was announced by the regulator. Officials say that FD approval not only affects the export to the US market but other markets also depends upon the approval from the FDA.

The FDA had conducted an audit of the unit in 2010 and had found some issues and an import alert was announced. FDA officials conducted a fresh audit recently and the observations resulted in lifting of the alert against the unit. The alert was removed as it was found that the company is complying with the regulations of the regulator.