Lupin Gets USFDA Nod For HIV Drug Under PEPFAR
The Mumbai-based company Lupin has received a tentative nod from the US Food and Drug Administration (USFDA) under the US President's Emergency Plan for AIDS Relief (PEPFAR) for its new drug application (NDA) for Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate (TLD) tablets (50 mg/300 mg/300 mg), along with antiretroviral fixed dose combination (FDC), Lupin said in a statement.

The product would be manufactured at the company's Nagpur-based facility, it added. TLD tablets are recommended by the World Health Organisation (WHO), the US 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.

"It is a significant approval for the company 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," Lupin President (API Plus) Naresh Gupta noted.

Being integrated with in-house manufacture of active pharmaceutical ingredients (APIs) and formulations gives the company an opportunity to provide quality products and uninterrupted supplies for affordable access for patients in these countries, he added. Lupin's current global footprint spans 11 countries, across six continents.

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