APP Increases Heparin Production to Avoid Shortage

February 28, 2008
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

APP Pharmaceuticals will boost manufacturing of therapeutic multidose vials of heparin.

Schaumburg, IL (Feb. 19)-APP Pharmaceuticals will boost manufacturing of therapeutic multidose vials of heparin. The increased production comes in response to concerns on the part of hospitals and the US Food and Drug Administration about a potential heparin shortage.

APP acquires heparin USP from several manufacturers that were inspected and approved by FDA. The company said its Chinese supplier was inspected and approved by both FDA and China’s State Food and Drug Administration. That supplier is not associated with the Chinese raw material used in the therapeutic heparin under a current recall by another manufacturer, according to APP.

APP and FDA are collaborating to increase production capacity at the company’s manufacturing facilities. APP is also working with suppliers to increase and expedite deliveries. These measures will allow APP to produce enough product to meet US demand for therapeutic multidose vials of heparin.

In addition, APP instituted a direct-shipment program to control the distribution and expedite delivery of heparin to physicians and patients in urgent need.

In a press release, Patrick Soon-Shiong, APP’s chairman and CEO, said that the potential shortage of heparin is an important public health issue. “Accordingly, we are marshalling our resources to provide patients with this product, which plays such a crucial role in surgery and other life-sustaining procedures,” he said.

Heparin is an anticoagulant therapy for patients undergoing surgery, blood transfusions, extracorporeal circulation, dialysis procedures, and other treatments that require a blood-clotting inhibitor.

APP is a specialty drug company that develops, manufactures, and markets injectable pharmaceutical products. The company focuses on the oncology, anti-infective, anesthetic, analgesic, and critical-care markets.