Mumbai, Baltimore, February 06, 2024: Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) 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 Limited. 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 USD 15 million in the U.S. (IQVIA MAT December 2023).

About Lupin
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. 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 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 U.S. by prescriptions. The company invested 7.9% of its revenue in research and development in FY23.

Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.

Please visit www.lupin.com for more information.
Follow us on:
Twitter: https://twitter.com/LupinGlobal/
LinkedIn: https://www.linkedin.com/company/lupin
Facebook: https://www.facebook.com/LupinWorld/

For further information or queries please contact –
Heena Dhedhi
Deputy General Manager – Corporate Communications
Email: heenadhedhi@lupin.com

*Safe Harbor Statement
BromSite® is the registered trademark of Sun Pharmaceutical Industries Limited