Ranbaxy offers to help U S combat avian flu
02 Dec 2005
Mumbai: Ranbaxy Laboratories Ltd (RLL) has announced that if called upon by the US Government or by the innovator, Roche, Ranbaxy, being a global organisation, is geared to provide oseltamivir phosphate capsules (generic version of Tamiflu) to the US healthcare system to meet the threat of the avian flu that has now become a global concern. Dr Biran Tempest CEO and Managing Director, Ranbaxy Laboratories, said, " In terms of available capacity, within six months we anticipate being able to produce 22-tons per annum (TPA) of the active pharmaceutical ingredient (API) based on the Ranbaxy's API process. Within a twelve-month period, we expect to scale up our operations produce a total of 100tpa. The 22tpa translates to a total of approximately 300 million 75mg capsules, and within a year to a total of 1.3 billion 75mg capsules."
Explaining the logistics, Tempest adds, "The API would be manufactured in the Ranbaxy's FDA compliant facilities in India, and the capsules could be manufactured at its US facilities. 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."
In recent weeks Roche, the innovator, is said to have be in talks with Ranbaxy to explore various avenues for partnership between the two companies in order meet the immediate and critical requirements of oseltamivir phosphate.
Tempest says, "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. The company will make all efforts to work with the US FDA to secure approvals to manufacture the API as well as capsules within company's facilities in order to reach the projected goals as may be indicated by the US government. The company is prepared and are committed to meet the needs of the US healthcare system, and are able to willing to partner with other organizations, including the innovator, to effectively meet this public health challenge that threatens the US," he adds.
