Lupin has received approval from the United States Food and Drug Administration (USFDA) 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 USD 484 million in the U.S. (IQVIA MAT June 2022).
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
