FDA closes Zhejiang Huahai Pharmaceutical warning letter

Genéricos/General | Posted 19/11/2021 post-comment0 Post your comment

The US Food and Drug Administration (FDA) has stated that it has closed the warning letter issued to Chinese manufacturer Zhejiang Huahai Pharmaceutical in 2018.

Application V15a16

In 2018, levels of probable carcinogen, N-nitrosodimethylamine (NDMA), were found in the active ingredient of Zhejiang Huahai’s heart drug valsartan. This led to a global recall of the product.

The global recall was expanded to include two related drugs, losartan and irbesartan, manufactured by at least 10 companies. In addition, in 2019, there was also a recall of Zantac (ranitidine) following findings that the medication was also contaminated with the same cancer-causing agent [1]. The recalls affected generics and biosimilars manufacturers Novartis’ Sandoz, Teva, Mylan and Aurobindo Pharma. It is thought that drugs used by millions of people in as many as 30 countries could have been contaminated [1].

The latest FDA closeout letter has been issued following an FDA inspection at the Chunnan site in July 2021. Despite this, the company cannot sell its drugs in the US due to an import ban on 29 of its products.

European regulators reinstated Huahai’s valsartan certification in late 2019.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Carcinogen contamination halts distribution of generic Zantac [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 19]. Available from: www.gabionline.net/generics/general/Carcinogen-contamination-halts-distribution-of-generic-Zantac

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