SFDA Tightens Heparin Control
This article was originally published in PharmAsia News
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)
You may also be interested in...
Given its ever-growing role as a critical component of the global biopharma industry, you can’t afford not to be up to speed on Asia. This biweekly selection of insights from our experienced on-the-ground team will help.
Becton Dickinson will spend $1.2bn over the next four years to improve its drug-delivery device manufacturing capabilities. See what Eric Borin, president of BD, said about it here.
Pfizer is producing vaccine doses at scale now that it has buttoned down the manufacturing process.