- In the second crackdown this summer on a Chinese manufacturer of valsartan, the European Medicines Agency has withdrawn Zhejiang Tianyu's authorization to manufacture valsartan for medicines in the EU by suspending the company's certificate of suitability, also known as a CEP.
- The suspension follows the finding of low levels of the carcinogen N-nitrosodimethylamine (NDMA) in the valsartan made by Tianyu. Other health authorities are taking precautionary actions in their own countries, including recalling of medicines containing valsartan or stopping their distribution, the EMA said.
- A similar finding, but at higher levels, triggered a recall of Zhejiang Huahai's valsartan in July 2018. Zhejiang Huahai's certificate had already been suspended, preventing distribution of the product in the EU.
Both the European Medicine's Agency and the Food and Drug Administration keep a close eye on drugs imported from abroad. Valsartan has become the latest target of scrutiny after investigations revealed drug product made by Huahai contained NMDA.
In the U.S., there are some concerns the contamination issues should have been picked up earlier. A report in Bloomberg noted that Zhejiang Huahai had been the subject of an FDA inspection in May 2017, which found the company had ignored quality testing that revealed several unnamed drugs had not met U.S. standards.
The case of valsartan API is particularly noteworthy given the contaminant, but concerns over quality standards extend to both the Chinese and Indian pharma industries more broadly.
The FDA, for example, has issued more warning letters to Chinese and Indian drugmakers in recent years, raising the profile of quality issues at foreign manufacturers.
Issues at one or two manufacturers can ripple outwards, too.
More than a dozen companies and repackagers affected by the contaminated valsartan have made voluntary withdrawals in the U.S. The knock-on effect of withdrawals can lead to drug shortages, depending on how many manufacturers there are in a market.