Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate (DLT) tablets are the first-line, preferred regimen for HIV patients as per latest WHO guidelines, the company said.
“Aurobindo is now among the first few companies which has received approval for this product,” it said.
The product has previously received a tentative approval from the US FDA.
The approval from the South African Health Products Regulatory Authority will enable Aurobindo to participate in South African HIV tender as well as launch in private market.
Africa is a key market for HIV drugs.
Headquartered at Hyderabad, India, Aurobindo manufactures generic pharmaceuticals and active pharmaceutical ingredients.
The company sells antibiotics, anti-retrovirals, CVS, CNS, gastroenterologicals, anti-allergies and antidiabetics in nearly 150 countries.