Global pharma major Lupin Limited (Lupin) has received tentative approval from the United States Food and Drug Administration (FDA) under the US President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for dolutegravir lamivudine and tenofovir alafenamide tablets. This product would be manufactured at Lupin’s Nagpur facility in India.
Commenting on the same, Naresh Gupta, president - API and Global Institution Business, Lupin said, “At Lupin, we are unwavering in our commitment to providing affordable and quality treatment options for patients in low and middle-income countries. We are pleased to receive the US FDA’s tentative approval of dolutegravir lamivudine and tenofovir alafenamide tablets, which significantly bolsters our HIV portfolio.”
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
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