Lupin launches generic version of Revatio in US market

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The drug major announced the launch of Sildenafil for oral suspension in the US market with an approval from the US Food and Drug Administration (USFDA).

The said drug is an equivalent generic version of Revatio for oral suspension of Viatris Specialty LLC.

Sildenafil for oral suspension treats pulmonary arterial hypertension (PAH), a condition that causes high blood pressure in the lungs. It works by relaxing your blood vessels and lowering the blood pressure in your lungs, which makes it easier for your heart to pump blood to the rest of your body.

According to IQVIA MAT July 2022, Sildenafil for oral suspension had estimated annual sales of $64 million in the United States.

Meanwhile, the pharma giant's Tarapur facility in Maharashtra has received US drug regulator's warning letter. This action follows the inspection of the unit by the US Food and Drug Administration (USFDA) from 22 March 2022 to 4 April 2022.

Lupin said it believes that the USFDA warning letter will not impact the supplies or the existing revenues from operations of this facility. The company said it will address the concerns raised by the U.S. FDA and will work with the U.S. drug regulator to resolve these issues at the earliest.

Lupin is an innovation-led transnational pharmaceutical company. The company 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 the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The drug maker reported a net loss of Rs 89.1 crore in Q1 FY23 as against a net profit of Rs 542.5 crore in Q1 FY22. Total revenue from operations declined 12.3% YoY to Rs 3,743.8 crore during the quarter.

Shares of Lupin declined 2.13% to Rs 656.20 on the BSE.

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