FDA closes Zhejiang Huahai Pharmaceutical warning letter

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FDA closes Zhejiang Huahai Pharmaceutical warning letter

Genéricos/General | Posted 19/11/2021 0 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.

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.

FDA lifts import ban on Chinese API to prevent shortages

LATIN AMERICAN FORUM The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. View last week’s headline article: Regulación del registro de medicamentos biológicos en América Latina Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español. Vea el artículo principal de la semana pasada: Regulación del registro de medicamentos biológicos en América Latina Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa.

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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