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Alembic Pharma Share Jumps 5% After USFDA Approves Glaucoma Drug

The US regulator had inspected its Gujarat plant from 28 February to 8 March.

Shares of Alembic Pharmaceuticals rose 5% in early trading on March 31 after receiving final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for brimonidine tartrate ophthalmic solution 0.15%.

Alembic Pharmaceuticals said in its press release that the approved ANDA is therapeutically equivalent to AbbVie Inc’s Alphagan P Ophthalmic Solution, 0.15%.

It added that brimonidine tartrate ophthalmic solution, an alpha-adrenergic receptor agonist, is indicated for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

According to IQVIA, the market size for brimonidine is estimated at $97 million for the 12 months ending December 2022.

The company has cumulatively received 180 ANDA approvals (156 final and 24 tentatives) from US health regulators.

Alembic Pharmaceuticals was quoted at Rs 484.10 on the BSE at 9:19 am, up Rs 15.80, or 3.37%.

The stock touched a 52-week high of Rs 792.30 on April 28, 2022, and a 52-week low of Rs 463.30 on March 29, 2023. It is trading 38.9% below its 52-week high and 4.49% above its 52-week low.

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