Teva confirms US FDA warning letter for Hangzhou, China API plant

By Gareth Macdonald contact

- Last updated on GMT


Related tags: Generic drug, Food and drug administration, U.s. securities and exchange commission

Teva Pharmaceutical Industries says the US FDA has raised concerns about its API plant in Hangzhou, China.

The Israeli manufacturer reported the US Food and Drug Administration (FDA) warning letter in a Securities and Exchange Commission (SEC) filing last week​, explaining that it followed an inspection conducted in September.  

Wendy Kouba, head of communications at Teva Global Operations, confirmed the letter, telling us the plant in question is in Hangzhou, capital of China’s Zhejiang province.

"The letter cites concerns with manufacturing control and sampling processes​" Kouga explained.

She also said Teva “is already in the process of undertaking corrective actions to address both the specific concerns raised by investigators as well as the underlying causes of those concerns​” adding that it plans to respond to the FDA letter by May 1.

The SEC filing follows just weeks after Teva announced – on page 13​ – it is “in the process of addressing quality issues raised in connection with an FDA audit of our active ingredient production facility in China​.”

While Teva still makes the majority of its annual revenue - $21.9bn (€20.7bn) in 2016 – from generic drugs, revenue from the sale of APIs to third parties increased last year.

According to the firm​, external API revenue was $776m, up 4% year-on-year.

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