Teva’s Gödöllő plant, located on the outskirts of Budapest, Hungary, makes over 200 sterile injectable products, but the Israeli-headquartered company will close its doors by the end of next year.
“Teva proposes to eliminate approximately 500 positions in the coming months,” associate director, corporate communications Jayson Otke told in-PharmaTechnologist, but production at the Gödöllő facility is planned to continue at a reduced capacity until June 2018.
The decision to sell or close the facility “was part of the company’s global network operations strategy, which is intended to better align production capacity with market and patient demand globally,” he said.
Despite the decision to vacate the Gödöllő facility, Otke says Teva will continue to operate in Hungary.
“Teva remains fully committed to operating in Hungary. The TEVA plants at Debrecen and Sajóbábony, as well as Teva’s commercial organization - with more than 2,000 employees - are not included in this plan. Teva will also continue its ongoing investment in its local production and R&D activities in Debrecen,” he told us.
The Gödöllő facility has been subject to regulatory problems over the past couple of years. In January 2016, the US Food and Drug Administration (FDA) inspectors identified deviations from current good manufacturing practice (cGMP).
A follow-up inspection of the site in May earned the plant a US FDA import alert.
In June, Teva confirmed it had stopped making all but two sterile injectable drugs at the plant.
In October of the same year, the FDA issued the plant with a Warning Letter, following agency concerns about cGMP violations.