Leading Indian pharmaceutical company Ranbaxy Laboratories Limited has offered to provide oseltamivir phosphate capsules (generic version of Tamiflu) to the United States healthcare system to meet the possible threat of avian flu.
RUS-based oche Laboratories has, in fact, been in talks with Ranbaxy in recent weeks to explore various avenues for partnership between the two companies in order to meet the immediate and critical requirements of oseltamivir phosphate.
Brian Tempest, CEO and managing director of RLL, said it would able to produce 22 tonnes of Active Pharmaceutical Ingredient based on Ranbaxy's proccess within six months.
"Within a twelve month period, we would expect to scale up our operations to produce a total of 100 TPA. The 22 TPA level 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," he added.
The API, he said, would be manufactured in 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 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," he said, adding that Ranbaxy would make all efforts to work with the USFDA to secure approvals to manufacture the API as well as capsules within Ranbaxy facilities in order to reach the projected goals as may be indicated by the US government.
"We are prepared and are committed to meet the needs of the US healthcare system, and are willing and able to partner with other organisations, including the innovator, to effectively meet this public health challenge that threatens the US," Tempest concluded.
The company serves customers in over 100 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 46 countries and manufacturing operations in seven countries.
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