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The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Alphagan P Ophthalmic solution, of AbbVie Inc.
Brimonidine Tartrate Ophthalmic solution is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
According to IQVIA, Brimonidine Tartrate Ophthalmic solution, had an estimated market size of $97 million for twelve months ending December 2022.
The pharma company said that it has a cumulative total of 180 ANDA approvals (156 final approvals and 24 tentative approvals) from USFDA.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. The company manufactures and markets generic pharmaceutical products all over the world.
The drug maker reported 29% drop in consolidated net profit to Rs 121.92 crore despite a 18.7% rise in net sales to Rs 1,509.02 crore in Q3 FY23 over Q3 FY22.
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