Tag:
Heparin
Latest Headlines
Latest Headlines
Quick-change: China puts oversight burden on drugmakers
Hot off a scandal in which gelatinmakers that feed the drug capsule industry were found to be using industrial, not food-grade, product, China is imposing new rules on drug manufacturers to audit excipient suppliers.
FDA wants foreign drug and API makers for supply chain security program
The FDA is again soliciting 100 foreign API makers for a pilot program intended to help allow them to import products faster if they agree to meet certain manufacturing and supply chain standards. The idea is that if the agency has API companies it knows it can trust, it can focus more resources on those that it can't.
China investigates 43 drug manufacturers tied to adulterated drug capsules
Illustrating the regulatory challenges emanating from drug manufacturing in China, authorities there have recalled 13 medications filled in capsules believed to contain excessive amounts of chromium.
FDA says APP ignored consumer complaints for 18 months
New details about problems with the production of heparin and other drugs by APP Pharmaceuticals ( $APPX ) have been released by the Food and Drug Administration on its website.
FDA seeks 3 years of heparin test results from APP Pharmaceuticals
APP Pharmaceuticals ( $APPX ) has had its production of heparin called into question in an FDA warning letter and has been ordered to present three years worth of out-of-specification results for...
FDA cracks down on Chinese heparin material providers
The contaminated heparin saga continues. The FDA has put 14 more Chinese suppliers that made a tainted ingredient for creating the widely used blood thinner on a watch list, and U.S. regulators are...
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...
UPDATED: FDA inspects three Merck KGaA plants along EU supply chain
The FDA found problems at three Merck KGaA API and drug manufacturing facilities along a single supply chain in Europe last summer from which ingredients were fed to a plant in Germany. It is unusual...
FDA asks heparin makers to test APIs for contaminants, including BSE
Citing patient deaths from contaminated heparin from China, the FDA has released recommendations that manufacturers test crude heparin to make sure the ingredient comes only from pig intestines. The...
Pew pushes for better FDA oversight of global supply chain
Some consumer advocates are out to make outsourced pharmaceutical manufacturing into a potent political issue in Washington. With the PDUFA reauthorization up for debate, Allan Coukell, director of...
