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Aurobindo Pharma Ltd has received approval from the South African Health Products Regulatory Authority (SAHPRA) for its Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate (DLT) tablets. The approved tablets are the first-line preferred regimen for HIV, according to the latest WHO guidelines.
Aurobindo is now among the first few companies to have received approval for this product. “This approval enables the company to participate in a South African HIV tender as well as launch in the private market. The approval further strengthens Aurobindo’s HIV product basket in South Africa,'' the Hyderabad-based company said in a release issued here on Tuesday.
Prior to SAHPRA’s approval, Aurobindo had received tentative approval for the drug from the US Food and Drug Administration, and had launched in sub-Saharan African markets.
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