Stabilizing the Heparin Marketplace
Key increases in Fresenius Kabi USA, LLC Heparin Production From January, 2008 – March, 2008
- Fresenius Kabi USA, LLC meets U.S. demand for safe supply of heparin
- Fresenius Kabi USA, LLC's heparin production more than doubles
- Direct shipments increase 250%
- Small package deliveries increase 220%
- Customer service calls to Fresenius Kabi USA, LLC increase 280%
- Manual orders for Fresenius Kabi USA, LLC's heparin increase 400%
Increased adverse events lead to the recall of other manufacturer's product.
APP makes a strategic plan to address short-term supply issue.
Other manufacturer's heparin is removed from distribution channels, hospitals and clinics due to severe allergic reactions.
APP takes steps to increase capacity to adequately supply U.S. demand for heparin. APP establishes emergency inventory to address the urgent need within the marketplace.
FDA and APP collaborate to ensure a safe supply of heparin.
APP and the FDA work together to continue to address the short-term demand, as well as increase production to refill the distribution pipeline.
The FDA mandates additional testing requirements for all heparin (NMR and CE).
APP proactively tests its heparin products, which continues to pass inspection. The FDA simultaneously tests the product.
Modifications at APP's manufacturing facilities are made to increase capacity supply to the U.S. market and pass FDA inspection.
Other manufacturers continue to recall heparin in the U.S. and other countries. APP becomes the sole supplier of unfractionated heparin.
APP continues to increase direct shipments for hospitals and clinics, including overnight packages to address immediate needs.
APP continues to exceed production capacity to refill the heparin distribution pipeline, and collaborate with the FDA to establish new safety processes, and expedite adverse reporting for heparin.