Lupin gets FDA nod for HIV drug; to be manufactured in Nagpur unit

Global pharma major Lupin Ltd on Wednesday (September 24) said it has received tentative approval from the United States Food and Drug Administration (FDA) for its generic version of an HIV drug.

The product,

bictegravir, emtricitabine, and tenofovir alafenamide tablets (50 mg/200 mg/25 mg), will be manufactured at Lupin’s Nagpur facility.

 It is the generic equivalent of Biktarvy tablets of Gilead Sciences Inc, indicated for the treatment of HIV infection in adults and paediatric patients weighing at least 25 kg.

"According to IQVIA MAT July 2025, Biktarvy had estimated annual sales of USD 16.2 billion in the US," the press release stated.

Separately, on September 20, Lupin disclosed that it had received four observations from the FDA following a product-specific pre-approval inspection at its biotech facility in Pune. The inspection was conducted between September 8-19.

The company said it would respond to the regulator within the stipulated timeframe, adding that it remains committed to adhering to current Good Manufacturing Practices (cGMP) across all its facilities.

Earlier, on September 18, Lupin had secured FDA approval for its drug to treat multiple myeloma. The drug, lenalidomide capsules, is in the 2.5 mg to 25 mg range.

Shares of Lupin Ltd ended lower on Wednesday (September 24) by 0.80% at ₹1,991 on the NSE.

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