Teva is giving up on its sterile injectables plant in Godollo, Hungary, that halted production after the FDA found manufacturing failings. The generics maker is laying off hundreds of workers in the next few months and will sell or close the plant by the end of next year.
Globes, citing reports in Hungarian media, says the generics maker will lay off about 500 workers in coming months but will continue limited production from the facility outside of Budapest. The company is working with authorities in Hungary as it searches for a buyer, the newspaper said. The decision does not affect Teva’s other operations in the country.
The report comes just weeks after Israeli media reported that financially struggling and management-challenged drugmaker was looking to cut up to 6,000 jobs. A company spokeswoman at the time confirmed plans to reduce costs, but said Teva “does not have a headcount target” because the number of job cuts would depend on the “right-sizing of each individual area of our business.”
The FDA last fall issued a warning letter that cited concerns about sterility and contamination issues at the plant and gave the company a long list of marching orders that it said had to be completed before the plant will be allowed to again ship product to the U.S.
Teva at the time said it was working diligently to address all of the FDA concerns, while also is working to replenish critical and priority products as quickly as possible. It said manufacturing for some products might be moved to other suppliers. A spokesperson could not be reached today.
The plant, which Teva opened in 2012 to expand its injected drug capacity, suspended production in February after an FDA inspection that uncovered the problems. The FDA last May put the plant on its import alert list, banning all but two drugs–the cancer treatment bleomycin and antibiotic amikacin, which were exempted to avoid shortages. Teva recalled all other unexpired drugs that were still in the U.S.
By Eric Palmer
Source: Fierce Pharma
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