Ranbaxy says set to make large quantity of Tamiflu

Indian generic drug company Ranbaxy Laboratories Ltd. said on Thursday that it was prepared to produce large quantities of Tamiflu for the United States to help meet the threat of avian flu and was in talks with the drug’s maker, Roche Holding AG.

Ranbaxy said within a year it could provide enough oseltamivir phosphate - the active ingredient in Tamiflu - to produce 1.3 billion 75 milligram capsules.

Within six months of beginning production, Ranbaxy believes it can produce 300 million capsules.

“It is estimated that within the first six months approximately 20 million patients could receive a course of treatment, and within the first year in excess of 100 million patients could be managed for the avian flu,” Ranbaxy Chief Executive Brian Tempest said in a statement.

The active ingredient could be manufactured at Ranbaxy’s facilities in India, which have received the U.S. Food and Drug Administration’s approval. The drug maker said capsules could be produced at its U.S. plants.

Doctors and healthcare officials hope that Tamiflu may help reduce the symptoms of avian flu if it begins to easily infect people. But studies so far show that it will require high doses of the drug, which is also needed to help alleviate the seasonal flu.

Swiss drugmaker Roche recently came under fire from critics who said it was reluctant to share its Tamiflu formula or grant permission to others to produce it in order to help satisfy mounting global demand for the drug.

Roche has since eased its stance, and Ranbaxy said the Swiss company has discussed ways they can work together to meet the demand.

“The starting material (shikimic acid) is critical to the entire process, and all efforts will be made to secure the required quantities from a variety of independent sources,” Tempest said.

Ranbaxy said it will work with the FDA to secure further manufacturing approvals.

“We are prepared and are committed to meet the needs of the U.S. health-care system and are willing and able to partner with other organizations, including (Roche), to effectively meet this public health challenge,” Tempest said.

Provided by ArmMed Media
Revision date: July 3, 2011
Last revised: by Sebastian Scheller, MD, ScD