Lupin Secures Nod From US FDA for Bromfenac Ophthalmic Solution

Lupine Limited (hereafter Lupin), an international pharmaceutical company, has received approval from the US Food and Drug Administration (FDA) to submit a New Drug Application for Bromfenac 0.075% Ophthalmic Solution to be marketed as a vaccine product similar to BromSite 0.075 Ophthalmic Solution. It showed % from Sun Pharmaceutical Industries Limited. Lupine is exclusive to the first file for this product. This product is manufactured in Lupin's Pithampur, India.

Bromfenac 0.075% eye drops treat postoperative inflammation and prevent eye pain in cataract surgery patients.

Bromfenac Ophthalmic Solution 0.075% (BromSite) estimated US$15 million annual sales (IQVIA MAT Dec 2023).

Lupine is a new multinational pharmaceutical company based in Mumbai, India. The company develops and markets various brands and formulations, biotech products, and APIs in more than 100 markets in the US, India, South Africa, Asia Pacific (APAC), Latin America (LATAM), Europe, and other regions. Middle East Region. Bromfenac ophthalmic solution, 0.075%, treats postoperative inflammation and prevents eye pain in patients undergoing cataract surgery.

Lupine's journey is a testament to the power of human imagination, love and the power of tomorrow. In 1968, its first founder, Dr. Founded by Desh Bandhu Gupta, Lupine has grown from humble beginnings to become a global healthcare leader. Headquartered in Mumbai, India, they have a presence in over 100 countries in the US region.