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European regulators have issued a notice claiming that a Chinese-made ingredient in generic drugs for brain cancer does not conform to manufacturing standards after European Union inspectors asked to inspect the factory of Jiangsu Taxus Pharmaceutical Co., Ltd. but were refused.
The incident was disclosed in a notice issued this week by the European Medicines Agency, the latest case of regulatory problems facing Chinese-made bulk pharmaceutical raw materials.
Prior to this, Valsartan, a heart disease ingredient supplied by Huahai Pharmaceutical (600521. SS), was contaminated, leading to the global recall of finished products containing Chinese ingredients.
US officials recently recalled active ingredients from thyroid powder (pig *) from China because of their unstable quality.
In the latest case, Jiangsu Taxus Pharmaceuticals refused to inspect production sites by Hungarian officials acting on behalf of the European drug regulatory system. The incident led European Union authorities to determine that the company's supply of temozolomide, a brain tumor drug, did not conform to good manufacturing practices (GMP).


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