The US Food and Drug Administration (FDA) has banned imports of active pharmaceutical ingredients (API) and finished drug products produced by China’s Zhejiang Huahai Pharmaceuticals (ZHP), the company at the center of the tainted valsartan crisis.
The FDA’s “import alert,” issued September 28, follows a recent inspection of the company’s Chuannan facility in Linhai, China, which uncovered numerous manufacturing and quality control issues, the FDA said.
The import alert is designed to “protect US patients” while the company “fully determines how impurities were introduced into its API and remediates its quality systems,” the FDA said.
The import alert freezes all API and finished drug products made by ZHP from legally entering the United States.
Valsartan is an angiotensin II receptor antagonist used to treat hypertension and heart failure. This past July, some valsartan products manufactured by ZHP were found to be contaminated with N-nitrosodimethylamine (NDMA), a potential carcinogen, which led US and European regulators to pull all affected valsartan products from the market.
The European Medicines Agency (EMA) announced today that an inspection by European Union (EU) authorities in collaboration with the European Directorate for the Quality of Medicines found that Zhejiang Huahai did not comply with good manufacturing practice in the manufacture of valsartan at the same Chuannan site in Linhai.
The latest European inspection, which focused on the manufacture of valsartan and was completed in September, found several weaknesses, including deficiencies in the way the company investigated the presence of NDMA and another impurity N-nitrosodiethylamine (NDEA) in its valsartan products, the EMA said.
“As a result, a statement of non-compliance for the manufacture of valsartan has been issued and the site is no longer authorized to produce valsartan (and its intermediates) for EU medicines. This means that marketing authorization holders in the EU are prohibited from using valsartan from the site for the production of medicines,” the EMA said.
This action comes after valsartan medicines from ZHP were recalled in the EU and the company’s certificate of compliance with European standards for quality testing for valsartan was suspended.
“EMA and national authorities in the EU are now actively considering all available evidence, including the outcomes of the European and US inspections, as part of the ongoing process of evaluating the Zhejiang Huahai manufacturing site. This will determine what further EU action may be required for other active substances produced by the site,” the agency said.
Last week, the EMA announced it was expanding its review of impurities in valsartan following the detection of very low levels of NDEA in another active substance, losartan, made by Hetero Labs in India. As a result, the agency’s review now includes medicines containing four other “sartans”: andesartan, irbesartan, losartan, and olmesartan.
The FDA has also recalled some valsartan-containing products manufactured by Hetero Labs, labeled as Camber Pharmaceuticals, after they were found to contain NDMA.
NDMA has also been detected in some valsartan medications made by a second Chinese drug maker, Zhejiang Tianyu Pharmaceuticals in Taizhou, China.
Cite this article: FDA Freezes Imports From Chinese Maker of Tainted Valsartan - Medscape - Sep 28, 2018.