Last October’s shutdown of Teva Pharmaceuticals Industries Ltd.’s facilities in Irvine is expected to potentially impact approximately 25 pharmaceutical injectables that were manufactured at the plant, including five essential medications where Teva supplied greater than 15% of the market in the last year, according to a report.
These products treat a variety of disease states, including cancer, adult and pediatric diabetes and pancreatic neuroendocrine tumors, said the May 17 report, which was produced by Irving, Texas-bases End Drug Shortages Alliance.
“We are surfacing the information and amplifying it so that all industry stakeholders are aware and can prepare for an unanticipated disruption,” said Terri Lyle Wilson, vice chair of the alliance and director of pharmacy, supply chain services for the Children’s Hospital Association.
“Information shared in this report highlights the level of transparency that is required across the supply chain to successfully navigate drug shortages.”
The company, which is headquartered in Tel Aviv, is the second-largest drugmaker in Orange County with about 300 workers here.
It closed its Irvine facilities after the Food and Drug Administration raised concerns about contamination issues.
An FDA inspection reportedly found Teva hadn’t repaired water damage at the site and hadn’t maintained procedures to keep factory workers from spreading mold and bacteria, according to Bloomberg News last year.
The company also failed to make sure equipment it installed more than two decades ago to test for sterility and harmful organisms worked properly, the report said.
Teva (NYSE: TEVA), which has a $10 billion market cap, reported 2021 sales fell 4.8% to $15.8 billion and net income of $417 million.
The company, which estimates nearly 200 million people daily take medicines it manufactures, has faced other regulatory issues as well. Last year, Teva recalled 2.5 million vials, many of them cancer medications.
Bloomberg last month reported Teva is willing to pay more than $5 billion combined to resolve more than 3,500 lawsuits over highly addictive opioid painkillers. Teva and other pharmaceutical companies last November won an Orange County case where a judge rejected a $50 billion lawsuit over allegedly misleading advertising.
The closed Irvine facilities weren’t identified.
Teva has operated several facilities in the Irvine Spectrum area, including its main building at 19 Hughes running some 88,000 square feet.
Whether Teva will reopen the Irvine facilities was unclear at press time. A spokeswoman didn’t return messages from the Business Journal.
Teva was created by more than 20 acquisitions over a 20-year period and is currently reducing its manufacturing plants from 80 to 40.
“That leaves a very complex footprint of offices, of manufacturing sites, of R&D sites,” Chief Executive Kare Schultz said in a February conference call with analysts.
The alliance, which was formed in November to disclose the causes of drug shortages and offer solutions, has more than 70 members, including manufacturers, distributors and group purchasing organizations.
The products manufactured at the closed Teva location in Irvine with market share above 15% include injectable presentations of alprostadil, amikacin, bleomycin, dacarbazine, idarubicin, ifosfamide, mitoxantrone, octreotide, streptozocin and topotecan.