Ranbaxy Laboratories Ltd is well prepared 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, if called upon by the US Government or by the innovator, Roche.
Dr. Biran Tempest CEO and managing director of Ranbaxy stated, "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 100 TPA. The 22 TPA translates to a total of approximately 300 million 75 mg capsules, and within a year to a total of 1.3 billion 75 mg. capsules. 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".
"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 the 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 willing to partner with other organisations, including the innovator, to effectively meet this public health challenge that threatens the US," added Dr. Tempest.
According to a company release, Roche, the innovator, has in fact been in talks with Ranbaxy in the recent weeks to explore various avenues for partnership between the two companies in order meet the immediate and critical requirements of oseltamivir phosphate.