Chinese Manufacturers struggle with Quality

While Chinese companies export about 50% of global APIs they struggle with international quality requirements

Chinese companies now account for more than 50% of the global active pharmaceutical ingredient (API) market. It has more than 500 companies registered to sell in the U.S. and 10 times that many serving its own market. But many of those continue to struggle to meet international standards.

As an example, Bloomberg points to the fact that last year, Chinese authorities ordered about 700 Chinese firms to review pending drug applications and withdraw any that were false or incomplete in an effort to step up its drug quality oversight. About three-quarters of the applications were voluntarily withdrawn or rejected by China’s regulators, even though some of the drugs also were approved for sale in the U.S.

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