Lupin rises on USFDA nod for strokes prevention drug

Lupin advanced 1.33% to Rs 759.15 after the pharma major announced that it has received approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA), Prasugrel tablets.

The approved ANDA is a generic equivalent of Effient tablets of Cosette Pharmaceuticals, Inc.

The product will be manufactured at Lupin's facility in Goa, India.

Prasugrel is used to prevent strokes, heart attacks, or other serious problems with your heart or blood vessels. It is given to patients before they have a heart procedure called percutaneous coronary intervention (PCI).

According to IQVIA MAT September 2022, Prasugrel tablets USP (RLD Effient) had estimated annual sales of $18 million in the U.S.

Meanwhile, the company said that the Spanish Ministry of Health (MSCBC) has approved the reimbursement of its NaMuscla for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders.

Mumbai-based Lupin is an innovation-led transnational pharmaceutical company. It 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.

On consolidated basis, Lupin reported net profit of Rs 129.73 crore in Q2 FY23 as against net loss of Rs 2,098.04 crore in Q2 FY22. Revenue from operations rose 2.2% to Rs 4,091.16 crore in Q2 FY23 as against Rs 4,003.42 crore in Q2 FY22.

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