Lupin gets US FDA approval for Bromfenac ophthalmic solution

Lupin Limited is a global pharmaceutical company.

Lupin Limited, a global pharmaceutical company, on August 16 announced that it has received approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application for a generic version of Bromday Ophthalmic Solution 0.09%, which is produced by Bausch & Lomb Inc.

This generic version, known as Bromfenac Ophthalmic Solution 0.09%, will be manufactured at Lupin's facility in Pithampur. The original Bromday product had approximately $11 million in annual sales in the US as of June 2023.

Earlier this week, the company announced that its unit-2 manufacturing facility located at Mandideep in India has successfully completed a GMP inspection by the United States Food and Drug Administration (USFDA).

Furthermore, earlier in August, Lupin's New Jersey-based subsidiary Novel Laboratories Inc received approvals from the US FDA for two variations of the fluocinolone acetonide oil. The estimated annual sales of the approved combination are around $10 million in the US.

The company had recorded a consolidated net profit of Rs 453.33 crore for the April-June quarter FY24, as against a consolidated net loss of Rs 86.8 crore reported in the same period a year ago. It reported a 28.6 percent increase in revenue at Rs 4,814.06 crore as against Rs 3,743.8 crore in the year-ago period.

Route mobile stock closed at Rs 1,537.00, up 0.40 percent on August 18.