By: IPP Bureau
Last updated : September 23, 2022 11:32 am
Diclofenac Sodium Topical Solution USP, 2% w/w (RLD Pennsaid) had estimated annual sales of US $484 million in the US
Global pharma major Lupin Limited has received approval from the US FDA for its Abbreviated New Drug Application (ANDA), Diclofenac Sodium Topical Solution USP, 2% w/w to market a generic equivalent of Pennsaid Topical Solution, 2% w/w of Horizon Pharma Ireland DAC. The product will be manufactured at Lupin’s facility in Pithampur, India.
Diclofenac Sodium Topical Solution USP, 2% w/w (RLD Pennsaid) had estimated annual sales of US $484 million in the US (IQVIA MAT June 2022).
Lupin, an innovation-led transnational pharmaceutical company, develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
The company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas.
Lupin is the third-largest pharmaceutical company in the US by prescription. The company invested 8.7% of its revenue in research and development in FY22.