The health regulator lifts the import alert for non-sterile products manufactured at Unit VI cephalosporin facility
New Delhi:
Aurobindo Pharma Ltd on Thursday said the US health regulator has lifted the import alert on its Hyderabad-based antibiotics facility, thereby allowing the company to export 9 products from this plant to the US market.
US Food and Drug Administration (USFDA) has lifted the import alert for non-sterile products manufactured at Unit VI cephalosporin facility based in Hyderabad, thereby, paving the way for resumption of exports of 9 products to the US market, Aurobindo Pharma Ltd said in a statement.
“Prior to import alert, the unit was having annual US sales of $33 million for the said products,” it added. In 2011, the USFDA had issued an import alert on products from the company’s Hyderabad-based cephalosporin facility, as a result of which its exports to the US market were affected.
The US health regulator had audited the cephalosporin facility, Unit VI of Aurobindo Pharma Ltd located at Chitkul Village, Hyderabad, Andhra Pradesh, in December 2010.
Subsequent to the audit findings, USFDA had imposed an import alert for detention on Aurobindo Pharma Unit VI products. Cephalosporins are a class of antibiotics which are indicated for the treatment of infections caused by bacteria.
Shares of Aurobindo Pharma were trading at Rs.141.90 on the BSE in the afternoon trade, up 8.61% from its previous close.
source: http://www.livemint.com / Live Mint & Wall Street Journal / Home> Companies / by PTI / Thursday, March 28th, 2013