Lupin gets tentative USFDA approval for DETAF tablets

The drug major announced that it has received tentative approval from US Food and Drug Administration (USFDA) for its new drug application for Dolutegravir, Emtricitabine and Tenofovir Alafenamide (DETAF) tablets.

Under the U.S. president's emergency plan for AIDS relief (PEPFAR), USFDA gave tentative approval for DETAF tablets. This product would be manufactured at Lupin's Nagpur facility in India.

The company said that DETAF would be a welcome new addition in the management of HIV infections and will be available for supplies to low- & middle-income countries, Lupin said in a statement.

Naresh Gupta, president - API and Global Institution Business, Lupin said, "We are committed to providing affordable and quality treatment options to patients in low- and middle income countries. We are pleased that U.S. FDA has tentatively approved DETAF, which will significantly enhance our HIV portfolio."

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

On consolidated basis the company reported net profit of Rs 129.73 crore in Q2 FY23 as against net loss of Rs 2,098.04 crore in Q2 FY22. Net sales rose 2.2% to Rs 4,091.16 crore in Q2 FY23 as compared to Rs 4,003.42 crore in Q2 FY22.

The scrip rose 0.25% to Rs 736.25 on the BSE.

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