US Food and Drug Administration Lifted Import Alert on Aurobindo Pharma

Aurobindo Pharma, the leading pharmaceutical research company in India, announced on 28 March 2013 that the US Food and Drug Administration (USFDA) lifted import alert on the Hyderabad-based antibiotics facility. This would enable Aurobindo Pharma to export nine products in all from its Hyderabad-based facility to US market.

The USFDA lifted import alert from the non-sterile products that are manufactured at the Unit-VI cephalosporin facility in Hyderabad. It is worth noticing that before this import alert, the Hyderabad-based antibiotics unit had annual sales of 33 million US dollar in America. USFDA had issued import alerts on the products of Aurobindo Pharma’s Hyderabad-based cephalosporin facility in 2011 because of which its exports had suffered.

In December 2010, the USFDA audited the cephalosporin facility, Unit VI of Aurobindo Pharma Ltd at Chitkul Village, Hyderabad. After the audit, USFDA had imposed import alert on Aurobindo Pharma. Cephalosporins are actually the class of antibiotics which are used for treatment of those infections that are caused by bacteria.

What is import alert?

Import Alert is the information to the FDA district offices concerning unusual or new problems affecting imports which give background and compliance guidance information for each product and problem.