Alembic Pharmaceuticals secures USFDA approval for Bromfenac Ophthalmic Solution

10 Jul 2024 , 10:09 AM

Alembic Pharmaceuticals Ltd announced on Tuesday that it has received final approval from the US Food & Drug Administration (USFDA) for its generic Bromfenac ophthalmic solution.

This approval is for the abbreviated new drug application (ANDA) of Bromfenac Ophthalmic Solution, 0.07%, which is used to treat postoperative inflammation and pain in patients undergoing cataract surgery.

At the time of writing on July 10, 2024 at 10:07 am shares of Alembic Pharmaceuticals is currently trading at ₹984 which is a 1.16% surge than the previous close. Alembic Pharmaceuticals stock has gained a total of 52% in the last one year, and 28% since the beginning of the year.

According to Alembic’s regulatory filing, the approved ANDA is considered therapeutically equivalent to the Reference Listed Drug (RLD) product, Prolensa Ophthalmic Solution, 0.07% by Bausch & Lomb Incorporated.

Bromfenac Ophthalmic Solution 0.07% belongs to the Nonsteroidal Anti-inflammatory Drug (NSAID) class and specifically targets reducing inflammation and pain in the eyes following cataract surgery.

Alembic Pharmaceuticals highlighted that the market size for Bromfenac Ophthalmic Solution 0.07% was approximately USD 168 million for the twelve-month period ending March 2024, based on IQVIA data.

Headquartered in Vadodara, Gujarat, Alembic Pharmaceuticals is a leading Indian multinational pharmaceutical company known for manufacturing pharmaceutical products, substances, and intermediates.

The company operates advanced manufacturing facilities in Panelav and Karakhadi (Gujarat) for producing active pharmaceutical ingredients (APIs) and formulations. Additionally, it has a facility in Sikkim dedicated to manufacturing formulations for both Indian and non-regulated export markets.