Germany Joins Probe Of China Heparin Sources
This article was originally published in PharmAsia News
German authorities are joining in the search for answers to the contamination in China of active ingredients in the blood-thinner heparin. The drug produced by Rotexmedica has been linked to about 80 allergic reactions in German patients, leading to a national recall. German authorities identified Changzhou Quianhong Bio Pharma and Yantai Dongcheng Biochemicals as the sources of heparin API and asked heparin producers to check to see if their API came from China. Although the U.S. FDA said its investigation of the Baxter source found concentrations as high as 20 percent of a substance that may be counterfeit, it has not established whether the same substance was responsible for allergic reactions. (Click here for more
You may also be interested in...
The company has no development programs left in its R&D pipeline and will focus entirely on the commercialization of IBS drug Linzess while seeking late-stage assets from external sources.
The documents issued by the US agency on 29 September set slightly different accuracy standards, reflecting the increased fragility of hospital patients.
The US FDA commissioner published a blog post commending and highlighting the work device center staff have done during the pandemic to speed tests and devices to market to save lives.