1-4 September, 2006 Pragati Maidan, New Delhi, India
    Ranbaxy, Cipla step up heat on tamiflu production



Despite awaiting Roche’s licence for production and petitioning the government for compulsory licensing, Indian companies have lined up capacities and markets for generic tamiflu (Oseltamivir).

Ranbaxy Laboratories Ltd said it was ready to provide oseltamivir phosphate capsules, a treatment for Avian influenza, to the US healthcare system if asked by Washington or Roche, the innovator.

The company has a current capacity to produce 300 million capsules (75 mg doses) which would be scaled up to 1.3 billion capsules a year.

Cipla, too, plans to start supplies of Tamiflu to some Asian and European countries from January, reports Dow Jones, quoting joint managing director Amar Lulla.
The generic major has a capacity to produce 750 kg of the drug a month, which can treat 750,000 patients.

“In terms of available capacity, within six months, we anticipate being able to produce 22 tonnes per annum (equivalent to 300 million capsules) of the Active Pharmaceutical Ingredient (API) based on Ranbaxy’s API process. Within a twelve month period, we expect to scale up our operations to produce a total of 100 tonnes per annum,” said Ranbaxy CEO and managing director Brian Tempest in an interview with a financial daily.

“The API would be manufactured in Ranbaxy’s FDA compliant facilities in India, and the capsules could be manufactured at its US facilities,” Mr Tempest added.

He said it was 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.
“The company will make all efforts to work with the USFDA to secure approvals to manufacture the API as well as capsules within the company’s facilities in order to reach the projected goals as may be indicated by the US government,” he added.

Roche is still believed to be in talks with several generic majors including Ranbaxy and Cipla to grant licences for the generic. It has also told the governments of Thailand, Indonesia and Philippines that they are free to produce Tamiflu.

Date: 08-Dec-2005

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