Marjorie Moeling, a spokeswoman at Ben Venue, told Outsourcing-Pharma.com that interim controls implemented to assure product quality “are not sustainable. The magnitude of continued investment and time required to overcome the systemic manufacturing challenges is not viable.”
The closure will affect all of Ben Venue’s employees – about 1,100 -- over a phased reduction starting this month, Moeling added, noting that they will continue into 2014 as Ben Venue winds down.
The age and condition of the facilities, as well as “the findings from our third-party current Good Manufacturing Practice (cGMP) experts and ongoing remediation needs, Ben Venue projects, in addition to the more than $350m invested to date, significant additional cumulative operating losses of approximately $700m over the next five years,” contributed to the closure, Moeling said.
The closure of one of the world’s largest sterile injectables manufacturers comes almost two years since it stopped manufacturing at full scale because of the quality of its products. The company was also hit with a consent decree earlier this year.
“The effort, magnitude of investment, and additional years required to remediate the facility before Ben Venue can return to sustainable production is not feasible,” she added.
Although the US FDA had allowed the company to continue manufacturing scaled-back amounts of some products, Ben Venue as recently as last week announced that further manufacturing issues were going to cause shortages of Johnson & Johnson’s cancer drug Doxil.
J&J also recently sued Ben Venue because of the issues that caused Doxil production to be halted. Doxil helps to treat ovarian, multiple myeloma and other cancers.
A Boehringer Ingelheim company established in 1938, Ben Venue Laboratories is the sterile injectables manufacturing arm of Bedford Laboratories.