FDA Warning Letter Could Impact Zhejiang Medicine’s US Foray
Zhejiang Medicine has become the latest major Chinese API firm to be hit with a US FDA warning letter amid stepped up oversight of production facilities in China by the US regulator, which has led to a string of similar actions this year alone. But efforts are now being made both by Chinese manufacturers and by authorities in the two countries to ensure adherence to international standards.
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US FDA’s drug GMP warning letters to API suppliers tripled in 2016, driven by data integrity findings in China and India and concerns about facilities and equipment maintenance. Trend could spell trouble for commercial production and launches. While there’s no turning back the clock on supply chain globalization, there’s no turning back the clock on FDA warning letters either.
As FDA and other regulatory authorities throughout the world learn how to conduct the type of inspections that have put a spotlight on data integrity failures in India, they are warning that no manufacturer, no matter how sophisticated they are, no matter where they’re located, is immune from this potentially devastating issue.
HIV drug Tivicay is expected to become cheaper in China under a recent manufacturing deal between ViiV and Desano. The Chinese firm expects to gain a 35% share of the global generic antiretroviral API supply market this year after patent licensing agreements with the Medicines Patent Pool.