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Teva plans sale of troubled Irvine plant

pharmafile | February 11, 2013 | News story | Manufacturing and Production |  FDA, Teva 

Teva has decided to sell off an injectable pharmaceutical production plant in Irvine, California, that was shut down temporarily for quality control problems.

The Israeli company’s chief executive Jeremy Levin told investors on the firm’s fourth quarter results call last week, that the decision had been taken as part of Teva’s ongoing restructuring programme, which was announced last year and aims to save $1.5 billion-$2 billion in costs over the next four years.

The Irvine plant closed in 2010 in the wake of a warning letter from the FDA – focusing on a number of violations including bacterial contamination of purportedly sterile products – a situation which contributed to a national shortage of the injectable anaesthetic propofol.

The closure cost Teva $230 million in lost sales in 2010, and while production started up again in mid-2011 Teva said it expected it would take the best part of a year to bring it back up to full operations. Meanwhile, the cost of remediation efforts has been significant, with the company indicating that $98 million was spent on the plant in the fourth quarter of 2012 alone.

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“Our desire is to supply more of our products from our more cost effective locations thereby beginning to optimise our entire network,” said Levin.

 Teva currently has five FDA approved sterile manufacturing sites from which to supply product including a new facility in Godollo, Hungary, and the company has been developing these to take over production of medicines made at Irvine.

“We are fully committed to the generic injectable sterile business in the US,” said Levin.

“Our goal is to sell the Irvine plant to a buyer with a strategic long-term interest in the facility who will continue to manufacture for Teva as we work towards moving these products other locations in our network,” he added.

Phil Taylor

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