Teva’s largest sterile medicines plant in Hungary placed on FDA import alert list
Teva Pharmaceutical’s facility in Hungary was placed on the US Food and Drug Administration’s import alert list. The action was taken after an FDA inspection found that the plant was not conforming to the current good manufacturing practices (GMPs). All drugs produced by the finished dosage forms facility – barring antibiotics Amikacin and Bleomycin – have been placed on the import alert list.
Teva had commissioned the US $ 110 million plant in Gödöllő, Hungary, in 2012. At the time, Teva had announced that the facility was one of the largest sterile medicines plants in the world. The plant has an annual production capacity of 160 to 200 million units of injectables and the six production lines can produce six different products simultaneously. It supplies medicines to patients in over 70 countries in Europe, North America, and the Far East.
The FDA import alert is bad news for Teva and comes at a time when investors believe the US $ 41 billion it paid for Allergan’s generic business was too high a price.
Teva Pharmaceutical’s facility in Hungary was placed on the US Food and Drug Administration’s import alert list. The action was taken after an FDA inspection found that the plant was not conforming to the current good manufacturing practices (GMPs). All drugs produced by the finished dosage forms facility – barring antibiotics Amikacin and Bleomycin – have been placed on the import alert list.
Teva had commissioned the US $ 110 million plant in Gödöllő, Hungary, in 2012. At the time, Teva had announced that the facility was one of the largest sterile medicines plants in the world. The plant has an annual production capacity of 160 to 200 million units of injectables and the six production lines can produce six different products simultaneously. It supplies medicines to patients in over 70 countries in Europe, North America, and the Far East.
The FDA import alert is bad news for Teva and comes at a time when investors believe the US $ 41 billion it paid for Allergan’s generic business was too high a price.
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