Drug firm Lupin Ltd on Wednesday (August 16) said it has received approval from the United States Food and Drug Administration (USFDA) to market the Bromfenac Ophthalmic solution.
NSE
Bromfenac Ophthalmic is used for pain or swelling of the eyes following a cataract surgery.
The approval granted by the USFDA is for Bromfenac Ophthalmic solution, 0.09%, a generic equivalent of Bromday Ophthalmic Solution, 0.09%, of Bausch & Lomb Inc, according to a stock exchange filing,
This product will be manufactured at Lupin's Pithampur facility in India, the company added.
According to IQVIA MAT June 2023, Bromfenac Ophthalmic Solution 0.09% (RLD Bromday) had estimated annual sales of $11 million in the US.
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Lupin develops and sells a wide range of branded and generic formulations, biotechnology products, and APIs (active pharmaceutical ingredients) 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 has 15 manufacturing sites, seven research centres, and more than 20,000 professionals working globally.
Shares of Lupin Ltd ended at Rs 1,112.95, up by Rs 31.25, or 2.89 percent on the BSE.