Chinese API manufacturer refused admittance to EU inspection

| By | API, China, Drug Quality Control, EMA

European medicines regulators have issued a notice that an ingredient for a generic brain cancer drug made in China does not meet manufacturing standards, after inspectors were refused entry to a factory run by Jiangsu Yew Pharmaceutical Co. Ltd.

The incident, reported in a notice published this week on a database maintained by the European Medicines Agency, is the latest example of regulatory problems with bulk pharmaceutical substances manufactured in China.

It follows a scandal over tainted supplies of the widely used heart drug valsartan from Zhejiang Huahai Pharmaceutical, which led to dozens of recalls around the world of finished tablets containing the Chinese product.

U.S. officials have also recently recalled porcine thyroid active ingredient from China due to inconsistent quality.

In the latest case, Jiangsu Yew refused to allow a site inspection by Hungarian officials, acting on behalf of Europe’s drug regulatory system. The rebuttal led the EU authorities to determine that its supplies of temozolomide, used to treat brain tumours, did not comply with good manufacturing standards.

According to the company’s export director Henry Yang the inspection was refused because Jiangsu Yew only made an intermediate product, rather than an active pharmaceutical ingredient (API), so an audit was not required.

Manufacturers in China and India supply more than two-thirds of all bulk pharmaceutical substances used in medicines, industry executives estimate, with China accounting for the lion’s share.

SOURCE: reuters
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