Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Bromfenac Ophthalmic Solution, 0.075%, to market a generic equivalent of BromSite Ophthalmic Solution, 0.075%, of Sun Pharmaceutical Industries. Lupin is the exclusive first-to-file for this product. This product will be manufactured at Lupin’s Pithampur facility in India.
Bromfenac Ophthalmic Solution, 0.075% is indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery. Bromfenac Ophthalmic Solution 0.075% (RLD BromSite) had estimated annual sales of $15 million in the U.S. (IQVIA MAT December 2023).
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.
