Global pharma major Lupin Limited has received tentative approval from the United States Food and Drug Administration (FDA) under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate (TLD) Tablets, 50 mg/300 mg/300 mg, and antiretroviral Fixed Dose Combination (FDC).

This product would be manufactured at Lupin’s Nagpur facility in India.

TLD is recommended by World Health Organisation (WHO), the U.S. Agency for International Development (USAID), and PEPFAR as a preferred first-line treatment regimen for the treatment of HIV in adults and pediatric patients weighing at least 35 kg, and will be available for supplies to low-and- middle-income countries (LMIC).

Commenting on the USFDA tentative approval, Naresh Gupta, President, API Plus, Lupin said “I am delighted that we have received FDA’s tentative approval for TLD. It is a significant approval for Lupin which has recently forayed into the HIV business arena. We have a deep commitment to increasing access to quality and affordable treatment options for low-and-middle-income countries for decades. Being integrated with in-house manufacture of APIs and formulations gives us an opportunity to provide quality products and uninterrupted supplies for affordable access for patients in these countries.”

Lupin is an innovation-led transnational pharmaceutical company which develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.

The company enjoys leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women’s health areas.