Aurobindo Pharma gets US FDA nod for Lamivudine

Aurobindo Pharma on Thursday said it had received US FDA approval for anti-retroviral Lamivudine, thus enabling it to participate in the president's emergency plan for AIDS relief), a US government initiative.

Approval for product, plant and bio-equivalence for active pharmaceutical ingredients and formulation with US FDA is an important qualifying criteria to participate in the programme, Aurobondo Pharma informed Bombay Stock Exchange.

The company manufactures both APIs and formulation for Lamivudine. Getting the US FDA is a very significant landmark in penetrating the global ARVs business, it said.

It has already filed several applications in the ARV segment with US-FDA, it said, adding the development can help it make a significant leap in the value chain from APIs to formulations in global ARV segment.

The company is fully vertically integrated in manufacturing APIs and formulations across most ARVs for the PEPFAR programe, it said.

It is participating in PEPFAR programme wherein around $15 billion are earmarked for this five-year programme, including around US $1 billion per year for medicines.