Alembic Pharma gets USFDA approval for ANDA

Gujarat-based pharmaceutical company Alembic Pharma announced that it got USFDA approval for ANDA Bromfenac solution, on Monday.

The company informed that it received approval for its Abbreviated New Drug Application (ANDA) Bromfenac Ophthalmic Solution 0.09 per cent from the US Food & Drug Administration (USFDA). The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Bromday Ophthalmic Solution, 0.09 per cent, of Bausch & Lomb Incorporated (Bausch & Lomb).

Bromfenac Ophthalmic Solution is indicated in the treatment of postoperative inflammation and helps in the reduction of ocular pain in patients who have undergone cataract surgery. The given solution has an approximate market size of US$6 million for 12 months ending December 2018 according to IQVIA. Alembic now has a total of 96 ANDA approvals (84 final approvals and 12 tentative approvals) from USFDA.

Alembic Pharma is a vertically integrated research and development company. Headquartered in Gujarat, India, it manufactures and sales generic pharmaceutical products all over the world.

Today, stock closed higher by more than 6 per cent at Rs. 506 on BSE. The benchmark index BSE Sensex ended lower by 50 points on 39145.