FDA triples list of banned Chinese heparin ingredient makers

Facing an ongoing House investigation over the tainted heparin episode, the FDA has identified another 14 Chinese companies that supplied contaminated materials to drugmakers.

This brings to 22 the number of Chinese suppliers that have been put on an import alert list to keep their products out of the supply chain, The Wall Street Journal reports. Those on the list can have their products stopped at U.S. borders.

In 2008, contaminated heparin marketed by Baxter International ($BAX) was tied to the deaths of 80 patients. More than 12 million people in the U.S. use the anticoagulant, WSJ says.

The incidents led to congressional hearings, during which lawmakers criticized FDA oversight of foreign drug manufacturers.

The FDA has released recommendations that manufacturers test crude heparin to make sure the ingredient comes only from pig intestines. The draft guidance also says manufacturers of the widely used blood clot prevention drug should audit their suppliers.

The agency has said it's found Chinese suppliers intentionally used oversulfated chondroitin sulfate (OSCS), an adulterated form of the active ingredient in heparin, because it was cheaper. "OSCS contamination of heparin appears to be an example of intentional adulteration, and has also been referred to as economically motivated adulteration," the agency has said.

- read the WSJ story 
- get more from Bloomberg

Suggested Articles

Recipharm has been building its capabilities in sterile injectable and inhalation drugs. Now it is buying a CDMO that manufactures devices for both.

The FDA has slapped the parent of Dollar Tree stores with a warning letter saying some CMOs that made its OTC products were among the world's worst.

GSK expects Shingrix supplies to rise slightly in 2020, but the real "step change" will come in 2024 with a brand-new manufacturing facility.