It states that the draft guidance alerts the manufacturer of active pharmaceutical ingredients and pharmaceutical and medical device manufacturer about the potential risks of crude heparin contamination. It further states that the FDA is seeking electronic and written comments on the notice by April 13,...
FDA has released a draft guidance for API manufacturers in response to a 2008 incident in which heparin sourced from China was adulterated with oversulfated chondroitin sulfate, causing serious adverse reactions in patients.Amy RitterePT--the Electronic Newsletter of Pharmaceutical Technology...
Food and Drug Administration (FDA) entitled "Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality." It says that the draft guidance is intended for Active Pharmaceutical Ingredients (API) and pharmaceutical manufacturers to the potential risk of crude heparin contamination. ...