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SFDA Tightens Heparin Control

This article was originally published in PharmAsia News

Executive Summary

To further tighten the control on heparin quality, China's State FDA has posted a notice that requires, starting April 9, all heparin producers to test for impurities such as chondroitin sulphate in heparin sodium products, including raw materials and injections. Besides following current testing standards, the manufacturers now need to add SFDA-approved complementary testing methods and items for heparin sodium and its injections. The companies also have to inspect each batch of raw materials and factory exports. All provincial-level food and drug administration offices will enforce the new regulation and stop errant producers from operating. (Click here for more - Chinese Language)

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