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Huahai Pharmaceutical

Controversies

Controversies tied to this brand in public sources. A listing is not a finding of fault.

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  1. 2018

    NDMA impurity found in valsartan API, triggering global recalls and import restrictions

    In 2018, the valsartan active pharmaceutical ingredient (API) produced by Huahai Pharmaceutical was found to contain the NDMA impurity. Multiple countries initiated recalls of affected medicines, and questions were raised about the timing of domestic disclosure and recalls. The company halted production and explained its risk assessment and communications with regulators; the United States and Europe subsequently imposed restrictions on products linked to its Chuannan production site. The incident was confined to the API and site involved.

    Source