Aurobindo Pharma Limited, Hyderabad-based pharma major,  has received final approval from the US FDA to manufacture and market lamivudine and zidovudine tablets USP 150/300mg (ANDA 202418) and is ready for launch.

Lamivudine and zidovudine tablets USP 150/300mg is the generic equivalent of ViiV Healthcare company's Combivir tablets USP 150/300mg and is indicated as part of antiretroviral (ARV) combination therapy for the treatment of human immunodeficiency virus (HIV) infected adults and children. The annual sale of products is approximately US$ 265 million.

The product has been approved out of Unit VII (SEZ) formulation  facility in Hyderabad, India.

Aurobindo now has a total of 150 ANDA approvals (122 final approvals including 1 from Aurolife Pharma LLC and 28 tentative approvals) from US FDA.

Aurobindo Pharma has manufacturing facilities that are approved by several leading regulatory agencies like US FDA, UK MHRA, WHO, Health Canada, MCC South Africa, Anvisa Brazil.