Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has resumed manufacturing at its Irvine, California injectable products manufacturing facility, following a warning letter from the US Food and Drug Administration (FDA) in December 2009, which listed "significant" manufacturing violations. Teva voluntarily closed the facility in April 2010
Teva said that the reopening of the plant will improve the availability of its injectable products in the US.
"The Wall Street Journal" reported today that fixing the problems at the plant took longer than Teva initially expected. Teva produced an anesthetic, Propofol, at the facility and some quantities were recalled in 2009 after elevated levels of toxins were discovered at the Irvine site. Teva has since stopped making the drug.
The paper added that Teva said that manufacturing problems at the site had cut sales by $230 million in 2010. p>"The Wall Street Journal" quoted a Teva spokeswoman as saying that the company expects that ramping up to full production at the plant would take most of the year.
In a separate matter, Teva has also submitted a complete response to the FDA's January 31, 2011, warning letter about its oral solid dose manufacturing facility in Jerusalem, following the implementation of corrective actions. The FDA had cited deficiencies related to laboratory reporting and quality control systems, and deemed a response to an earlier inspection as insufficient. Teva has asked the FDA to re-inspect the facility.
Teva's share price rose 0.6% on Nasdaq yesterday to $46, giving a market cap of $23.2 billion, and opened at NIS 157.80 on the TASE today, after falling 4.7% yesterday.
Published by Globes [online], Israel business news - www.globes-online.com - on April 27, 2011
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