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Alembic Pharma gets USFDA nod for generic ophthalmic drug

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The drug maker received a final approval from the US drug regulator for its Abbreviated New Drug Application (ANDA) for dorzolamide hydrochloride and timolol maleate ophthalmic solution.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Cosopt Ophthalmic Solution, 2% and 0.5% of Akorn Operating Company.

Dorzolamide hydrochloride and timolol maleate ophthalmic solution is a combination of dorzolamide hydrochloride carbonic anhydrase inhibitor, and timolol maleate, a beta-adrenergic receptor blocking agent, indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers.

As per IQVIA, dorzolamide hydrochloride and tirnolol maleate ophthalmic solution USP, 2% and 0.5% has an estimated market size of $80 million for twelve months ending December 2020.

Alembic Pharmaceuticals has a cumulative total of 143 ANDA approvals (125 final approvals and 18 tentative approvals) from the US-based drug regulator, USFDA.

Alembic Pharmaceuticals' consolidated net profit jumped 16.7% to Rs 237.41 crore on 6.1% increase in net sales to Rs 1,280.39 crore in Q4 FY21 over Q4 FY20.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.

Shares of Alembic Pharmaceuticals declined 3.89% to Rs 967.65 on BSE. The scrip hit intraday low of Rs 948 and an intraday low of Rs 1,003 so far.

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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

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First Published: Wed, May 05 2021. 11:13 IST
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