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Regulatory Focus™ > News Articles > 8 > EU Suspends Chinese Company From Manufacturing Valsartan Active Substances

EU Suspends Chinese Company From Manufacturing Valsartan Active Substances

Posted 20 August 2018 | By Ana Mulero 

EU Suspends Chinese Company From Manufacturing Valsartan Active Substances

China-based Zhejiang Tianyu Pharmaceuticals is no longer authorized to manufacture active substance for valsartan in the EU, the European Medicines Agency (EMA) said Monday.
The suspension of the company’s European Certificate of Suitability comes after an impurity, a probable human carcinogen known as N-nitrosodimethylamine (NDMA), was detected in its valsartan products earlier this month. Zhejiang Huahai Pharmaceuticals also had its certificate suspended.
Both Chinese companies have been involved in drug safety investigations regarding their valsartan products, produced in bulk, that have been found to contain the NDMA impurity.
“The levels of NDMA found so far in batches of valsartan from Zhejiang Tianyu are considerably lower than levels found in the active substance from Zhejiang Huahai,” EMA said in its latest update on its ongoing review of valsartan-containing medicines.
In a Friday update, Swissmedic noted a recall of batches from Zhejiang Tianyu Pharmaceuticals had been initiated in Germany. “As far as is known at present, Switzerland is not affected by this new development,” the regulatory authority added.
Regulatory authorities across Europe initiated a recall of certain medicines containing valsartan supplied by Zhejiang Huahai Pharmaceuticals in early July. In estimates released earlier this month, EMA said “there could be one extra case of cancer for every 5,000 patients taking the affected medicines at the highest valsartan dose (320 mg) every day for 7 years.”
The move by EU authorities was followed by the US Food and Drug Administration (FDA). Yet two Form 483s posted earlier this month suggests that the agency became aware of the quality defects associated with the Zhejiang Huahai Pharmaceuticals recalls nearly two years prior.
FDA has also previously issued at least one 483 to Zhejiang Tianyu Pharmaceuticals in 2015.
Meanwhile, the agency has also announced a series of voluntary nationwide recalls issued by drugmakers of valsartan products over the detection or the possible presence of the NDMA impurity. The latest recall, involving Torrent Pharmaceuticals, was announced on Friday. 


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