The approved solution is a generic equivalent of Pennsaid Topical Solution of Horizon Pharma Ireland DAC.
Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). Diclofenac topical (for the skin) is used to treat joint pain caused by osteoarthritis.
Diclofenac Sodium Topical Solution USP had estimated annual sales of USD 484 million in the U.S. (IQVIA MAT June 2022).
The product will be manufactured at Lupin's facility in Pithampur, India,” the company said in a statement.
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 rose 0.38% to Rs 663.70 on the BSE.
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