China's GMP breathing space could open generics entry door
This article was originally published in SRA
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. However, with recent circulars from the China Food and Drug Administration (formerly the State Food and Drug Administration) making it clear the country is determined to fully implement good manufacturing practice (GMP) regulations, establishing a joint venture may not be the only option for foreign companies wanting to gain a generics foothold1-3.
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