Lupin gets USFDA approval for generic HIV tablets

19 Dec 2024 , 11:48 AM

Lupin Ltd stated on Wednesday (December 18) that the US Food and Drug Administration (FDA) has approved its abbreviated new drug application (ANDA) for HIV tablets emtricitabine and tenofovir alafenamide, 200 mg/25 mg.

The approval enables Lupin to offer a generic version of Descovy pills, which were originally produced by Gilead Sciences Inc. Lupin was one of the first businesses to get approval for this generic formulation, which gives it 180 days of shared generic exclusivity in the US market. The product will be manufactured at Lupin’s Nagpur plant in India.

According to the firm, under Regulation 30 of the SEBI Listing Regulations, the permission was not considered relevant for stock exchange disclosure at the time. Lupin reaffirmed its commitment to making timely disclosures when a material event occurs.

Furthermore, the business is unaware of any additional event or information that was required to be reported but was not announced in accordance with the SEBI Listing Regulations. The company makes prompt disclosures where any event or information is deemed material or demands disclosure under the aforementioned Regulations, and will continue to do so,” it stated.

Lupin Ltd reported a 74.10% year-on-year increase in overall net profit to ₹852.63 Crore in the July-September quarter of FY25, boosted by higher sales.

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