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EU officials clash with Chinese firm on drug factory inspection

Reuters  |  LONDON 

By Ben Hirschler

LONDON (Reuters) - European medicines regulators have issued a notice that an ingredient for a drug made in does not meet manufacturing standards, after inspectors were refused entry to a factory run by 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 manufactured in

It follows a scandal over tainted 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 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 of temozolomide, used to treat brain tumours, did not comply with good

The company's told via email that the inspection was refused because Jiangsu Yew only made an intermediate product, rather than an (API), so an audit was not required.

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

In recent years, U.S. and European regulators have increased scrutiny of Asian drug factories following the adulteration of the blood thinner heparin, which sickened hundreds and caused the deaths of at least 81 Americans in 2007 and 2008.

(Reporting by Ben Hirschler; Editing by Jan Harvey)

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Wed, September 12 2018. 21:47 IST
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