Denise Bradley, a Teva spokesperson, told in-PharmaTechnologist that manufacturing and distribution was put on pause at the site in April 2010 and remains at a standstill.
She said: “Prior to this reduction, we have not laid off any employees as a result of this voluntary production hold. The jobs which are being eliminated are all various production jobs and support staff at the facility.”
Teva maintains that the job cuts and manufacturing hold are not part of a phased exit and said it is committed to working towards resuming production at the facility in the foreseeable future, though Bradley said she has “no estimate on timeframes.”
‘Jackson drug’ led to job losses
This is the second blow to the company in under a year as the Israeli generic drug maker slashed 70 jobs when it discontinued production of Propofol, the drug associated with the death of Michael Jackson.
Though Teva stressed the drug was not linked to Jackson’s death, the firm said it was forced to discontinue the medicine as it generated at best only marginal profits and was difficult to manufacture.
In 2009, Teva initiated a recall of more than 57,000 bottles of injectable propofol after 41 reports of patients falling ill with flu-like symptoms. Some of the recalled vials of the sedative were found to be contaminated with endotoxin bacteria, which resulted in several lawsuits being filed over the drug.
cGMP violations
The decision to suspend production and lay off employees at the Irvine plant was prompted by quality control after the company received an FDA warning letter for violating current good manufacturing practice (CGMP) regulations.
In the letter, the FDA criticized Teva of failing to test each lot of raw materials used in Propofol injectable emulsion for levels of bacterial endotoxin, and said the firm were unable to determine the cause of a higher than usual level of the bacteria found in three vials of the Propofol drug.
Sicor acquisition
The Irvine plant was obtained by Teva in 2004 when the firm shook hands on a $3.4bn (€2.5bn) deal to acquire US-based Sicor. The transaction came as part of Teva’s plan to secure itself the position as the world’s leading generics manufacturer.
Share prices closed down one per cent at $53.90 after news of Teva’s upcoming job cuts broke.