FDA releases method to detect NDMA and NDEA; issues clarification on import alert

By PharmaCompass

2018-10-18

Impressions: 115 Article

This week, the US drug regulator posted a redeveloped combined gas chromatography-mass spectrometry (GC/MS) headspace method for detecting the presence of impurities NDMA and NDEA in valsartan drug products.

Previously, the FDA had posted a GC/MS method for detection of NDMA in valsartan products. Upon detection of NDEA in valsartan products manufactured by Zhejiang Huahai, FDA redeveloped the testing method so that it can be used to detect and quantify levels of both NDMA and NDEA. In their announcement the FDA stated that the method should be validated by users if the resulting data are used to support a required quality assessment of the API or drug product, or if the results are used in a regulatory submission.

The agency is also working on a GC/MS direct injection method for detection of NDMA and NDEA. PharmaCompass will post the method when it is available. This will provide an additional option before regulators and the industry to detect the two impurities.

Meanwhile, the FDA clarified that it’s just one site of Zhejiang Huahai on which the import ban has been slapped.

On September 28, the FDA had announced it had imposed an import alert banning “all” APIs made by Huahai and finished drug products made using Huahai’s APIs from entering the US. But the actual import alert on the FDA website appeared to be directed only to the Chinese pharma’s Chuannan site in the city of Taizhou, China. FDA corrected this mistake recently.

In an alert, Health Canada said it had found the Chuannan manufacturing site of Huahai to be non-compliant with requirements of good manufacturing practices for the manufacture of APIs.

It also listed the products manufactured at the Chuannan site. These are — “candesartan, irbesartan, losartan, olmesartan, telmisartan, and valsartan, which are used in the manufacture of a class of drugs known as angiotension receptor blockers (drugs that are used to treat high blood pressure and heart failure); levetiracetam, which is used in the manufacture of an anti-epileptic drug; nevirapine, which is used in the manufacture of an antiviral drug; and repaglinide, which is used in the manufacture of an anti-diabetic drug,” Health Canada said.

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