FDAnews
www.fdanews.com/articles/62534-roche-establishes-u-s-based-supply-chain-for-tamiflu

ROCHE ESTABLISHES U.S.-BASED SUPPLY CHAIN FOR TAMIFLU

September 15, 2006

Roche has announced that a Tamiflu (oseltamivir phosphate) supply chain is now fully operational in the U.S., with an annual production capacity of 80 million treatment courses. The U.S. supply chain is part of Roche's global production network, which will be capable of producing 400 million treatment courses of Tamiflu annually by the end of 2006, a more than 10-fold increase since 2004.

Established at the request of the U.S. Department of Health & Human Services (HHS), the U.S. supply chain, which includes Roche sites as well as external contractors, encompasses all aspects of Tamiflu production, from synthesis of the initial starting material (shikimic acid) through all major steps of manufacturing to finished packs.

Tamiflu is approved for the prevention and treatment of influenza in adults and children 1 and older. Tamiflu is designed to be active against all clinically relevant influenza viruses and has been shown to be active against the H5N1 strain or avain flu.

HHS has ordered 21.3 million courses of Tamiflu for the U.S. Strategic National Stockpile, which will be delivered in full this year. The total targeted U.S. stockpile is 81 million antiviral treatment courses by the end of 2008.