China's GMP breathing space to open generic entry door?
This article was originally published in Scrip
Executive Summary
China's huge market for generic drugs is one reason that multinationals facing branded patent cliffs, such as Merck and Pfizer, are setting up joint ventures with local firms. But with a new circular from the State FDA making it clear the country is determined to fully implement good manufacturing practice (GMP) regulations, establishing a JV may not be the only option for foreign companies wanting to gain a generics foothold.