This is the first product reviewed under the expedited review provisions of the US President's Emergency Plan for AIDS Relief Programme. In combination with other anti-retroviral agents, Lamivudine tablets are for the treatment of HIV infection.
"We are pleased and proud of our achievement in being granted US FDA tentative approval for Lamivudine. This formulation now qualifies as our first product to be included among a portfolio of drugs to be associated with the PEPFAR initiative," said Brian W Tempest, CEO and managing director, Ranbaxy Laboratories.
We will continue to add products to this program to help patients afflicted with HIV AIDS. The Ranbaxy global organisation is committed and dedicated to this humanitarian effort," he added.
Ranbaxy, India's major pharmaceutical company, manufactures and markets brand and generic pharmaceuticals and Active Pharmaceutical Ingredients.
The company sells its products in over 100 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 44 countries and manufacturing operations in 7 countries.