Alembic Pharmaceuticals gets USFDA approval for ophthalmic solution

Alembic Pharmaceuticals has announced that it has received approval from US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Bimatoprost ophthalmic solution 0.03%.

As per IQVIA, the ophthalmic solution has a projected market size of US$76 million. Bimatoprost is used to treat high pressure inside the eye due to glaucoma (open-angle type) or other eye diseases.

Alembic Pharma has a cumulative total of 90 ANDA approvals, of which 78 have final approvals and 12 have tentative approvals from the USFDA.

During the recent quarter Q3FY19, its international formulations grew by 44 per cent, constituting US share of 69 per cent and non-US 31 per cent.

On Monday, the stock opened at Rs. 535 and made an intra-day high of Rs 540.40 on the BSE. At 3:15 p.m., the stock was trading nearly at Rs 533.85 on the BSE.