FDA, EMA highlight more concerns over APIs being sourced from China

By PharmaCompass

2018-08-24

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Earlier this month, two Chinese companies — Zhejiang Tianyu Pharmaceutical and Zhuhai Rundu Pharmaceutical — had come forth to say they were recalling blood pressure drugs tainted with N-nitrosodimethylamine (NDMA) in the valsartan API which had been used to produce their finished products that had been exported to Taiwan.

Prior to this, Chinese drug company Zhejiang Huahai Pharmaceutical had also halted the supply of valsartan to the US, and globally, regulators recalled blood pressure medicines with the tainted valsartan API manufactured by Huahai. NDMA is a genotoxic substance that could cause cancer.

This week, an EMA press release said Zhejiang Tianyu is no longer authorized to manufacture the valsartan active substance for EU medicines following the suspension of its CEP (a certificate of suitability verifying that the quality of its valsartan meets European requirements).

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