Alembic Pharma Receives USFDA Nod for Bromfenac ophthalmic solution

Alembic Pharmaceuticals Ltd said that the US Food and Drug Administration has granted final approval for its generic Bromfenac ophthalmic solution, which is recommended for the treatment of postoperative inflammation and pain in patients who have had cataract surgery. The US Food and Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA) for Bromfenac Ophthalmic Solution, 0.07 percent, Alembic Pharmaceuticals announced in a regulatory filing.

The pharmaceutical firm added that the approved ANDA is therapeutically identical to the Reference Listed Drug (RLD) product, Prolensa Ophthalmic Solution, which is 0.07 percent owned by Bausch & Lomb Incorporated.

Bromfenac Ophthalmic Solution 0.07 percent is a Nonsteroidal Anti-inflammatory Drug (NSAID) approved for the treatment of postoperative inflammation and decrease of ocular pain in patients who have had cataract surgery, according to the makers. According to Alembic, the market size is predicted to be USD 168 million for the 12 months ending March 2024, citing IQVIA statistics.

Alembic Pharmaceuticals Ltd. is an Indian multinational pharmaceutical firm based in Vadodara. It manufactures pharmaceutical goods, chemicals, and intermediates. It is also referred to as the market leader in the macrolides segment of anti-infective medications in India.

The company's headquarters and corporate office are in Vadodara, Gujarat, India, with production plants at Panelav, Karakhadi, Gujarat, and Sikkim, India.