Europe Shuts Out Huahai Pharma's Blood Pressure Drug Ingredients Over Carcinogens
Tang Shihua
DATE:  Jan 17 2019
/ SOURCE:  yicai
Europe Shuts Out Huahai Pharma's Blood Pressure Drug Ingredients Over Carcinogens Europe Shuts Out Huahai Pharma's Blood Pressure Drug Ingredients Over Carcinogens

(Yicai Global) Jan. 16 -- A European regulator has revoked Huahai Pharmaceutical's export license for two kinds of antihypertensive drug ingredients that were found to have excessive levels of cancer-causing substances. 

The European Directorate for the Quality of Medicines & HealthCare recalled Huahai Pharma's certification of suitability regarding irbesartan and losartan potassium bulk drugs, the Zhejiang-province based company said in a statement yesterday. 

The European Medicines Agency said last July that it found a carcinogen called N-nitrosodimethylamine, or NDMA, in Huahai's high blood pressure treatment valsartan. N-nitrosodiethylamine, or NDEA, a carcinogenic impurity, was also discovered in 27 batches of hypotensive drug ingredients worth CNY9 million (USD1.3 million), the company said in a separate statement on Jan. 9.

Huahai Pharma will evaluate risks involving the two drugs, establish quality control, and then submit a new application to the EDQM, it said yesterday. 

In 2017, Huahai exported CNY140.8 million (USD20.8 million) worth of these two types of active pharmaceutical ingredients to the European market, making up 2.8 percent of the firm's sales.

The company's shares [SHA:600521] have lost about two-thirds of their value since a 12-month peak last May amid a general slump in Chinese equities. They closed 1 percent down today at CNY10.66 (USD1.58), while the benchmark Shanghai Composite Index was little unchanged.

Editor: Emmi Laine 

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Keywords:   Crude Medicine,NDEA,CEP Revoked,Huahai Pharmaceutical,EU