According to a report by Hungarian regulator OGYE, an inspection by the US Food and Drug Administration (FDA) in January prompted the Israeli drug manufacturer to cease production at the facility.
OGYE, which visited the facility on February 5, said the facility had also stopped making more than 200 drugs it previously supplied to the Hungarian market.
Teva spokesman Eliran Levy confirmed production ceased in January. He told us the firm “decided to voluntarily stop production at the Godollo plant on a temporary basis while we evaluate and respond to FDA’s observations regarding our manufacturing and laboratory practices.
“We are working around the clock to restart manufacturing operations as soon as possible, and are working cooperatively with regulatory authorities to minimize any potential impact on product availability.”
Import alert
On May 27 the US FDA issued an import alert on almost all sterile injectable drugs made at the facility citing unspecified good manufacturing practices (GMP) problems.
Levy told us the plant is continuing to make the cancer medication bleomycin and the antibiotic amikacin.
Bleomycin is used to treat a variety of cancers. It was added to the US FDA’s list of drugs in short supply in April.
Teva is one of three companies that supplies the US market. The others, Fresenius Kabi and Hospira, reported problems sourcing the drugs active pharmaceutical ingredients and an unexpected increase in demand, respectively.
The antibiotic amikacin - which is used to treat hospital-acquired infections - is also on the FDA shortage list, although further details are not provided.
A post on Drugs.com suggests that, in addition to Teva, amikacin is supplied to the US by West Ward, Heritage and Fresenius Kabi.