Ranbaxy Laboratories Ltd has announced that it had received a tentative approval from the US Food and Drug Administration to manufacture and market Lamivudine tablets (150 mg) in the US.
Lamivudine tablets are used in the treatment of HIV in combination with other anti-retroviral agents.
This is India's first tentative approval from the USFDA under its expedited review process to support the US President's Emergency Plan for AIDS Relief Initiative.
Under the scheme, the US government procures drugs to make affordable medicines available in developing countries facing the AIDS epidemic.
It is worth noting that last year, the World Health Organisation had removed Ranbaxy from the list of companies supplying anti-AIDS drugs to it.
Since then, the company has re-started the process of registering its products with the WHO. Today's development gives a fillip to its anti-AIDS business.
Ranbaxy is one of the four companies identified by the Bill Gates Foundation to supply ARVs for its anti-AIDS campaign in the developing countries.
"Stocks picked under PEPFAR would be reaching mostly the Caribbean and African countries where the incidence of AIDS has attained epidemic status and where patent rights won't be infringed," a Ranbaxy executive said, though he did not clarify what would be the resulting business for the company.
