Under a new manufacturing agreement, Cardinal will manufacture 75mg hard gelatin capsules of Tamiflu (oseltamivir) on behalf of Roche at one of its undisclosed manufacturing sites in Europe.
Roche will supply Cardinal with the active pharmaceutical ingredient (API) required to make the drug.
The two-year contract is due to start in January, however, Cardinal is already producing test batches in order to gain regulatory approval, company spokesperson Troy Kirkpatrick told In-PharmaTechnologist.com.
"The contract with Roche states an undisclosed minimum volume of the drug to be produced by Cardinal, however, there is a ramp-up provision if Roche should require it," said Kirkpatrick.
"I believe Roche chose Cardinal as a manufacturing partner because we have already established a level of trust with them through our existing relationship."
Cardinal already has a separate contract in place for Tamiflu packaging and printed insert production at its facilities in the US.
The US-based firm is the latest in a long line of contract manufacturers enlisted by Roche to help boost manufacturing capacity of Tamiflu as it strives to ramp up its annual production capacity by 100m treatments to reach 400m doses by the end of 2006, in response to surging global demand from governments who are following advice from The World Health Organization (WHO) to stockpile antiviral drugs in case of a bird flu pandemic.
Tamiflu, a neuraminidase inhibitor, reduces the severity and spread of traditional flu and is recommended by the WHO as a front line treatment for bird flu.
In March, Roche expanded its external contractors to fifteen in nine different countries, as its needs for intermediates and finished product increased and companies such as Albemarle, Ampac, API Corporation, Clariant, DSM, FIS, Martek Biosciences, Novasep/Dynamit Nobel, PHT International, PPG Industries, Sanofi-Aventis, Shaanxi Jiahe Phytochem and Siegfried are now all involved in contributing to the overall production of Tamiflu.
Under further pressure in May to ensure cheap supplies of Tamiflu in Africa, Roche took a leap of faith and for the first time shared its know-how on Tamiflu with an African manufacturer, asking Aspen Pharmacare to produce finished doses of Tamiflu for the continent.