Alembic Pharma gets USFDA nod for Travoprost Ophthalmic Solution

Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Travoprost Ophthalmic Solution USP, 0.004...

Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Travoprost Ophthalmic Solution USP, 0.004% (Ionic Buffered Solution). This approved ANDA is therapeutically equivalent to the reference listed drug, Travatan Z Ophthalmic Solution, 0.004%, of Sandoz Inc. Travoprost ophthalmic solution is used to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The estimated market size for Travoprost Ophthalmic Solution USP, 0.004%, was US$ 61 million for the twelve months ending September 2025, according to IQVIA. Alembic Pharmaceuticals has a total of 232 ANDA approvals from the USFDA, comprising 212 final approvals and 20 tentative approvals.

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Why is Alembic Pharmaceuticals Limited in the news today?

Alembic Pharmaceuticals Limited (APLLTD) is in the news due to the company received final approval from the usfda for a new drug, which is a positive development for its product portfolio and market presence.

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Alembic Pharma gets USFDA nod for Travoprost Ophthalmic Solution

December 18, 2025, 05:32 AM

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Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Travoprost Ophthalmic Solution USP, 0.004% (Ionic Buffered Solution).

This approved ANDA is therapeutically equivalent to the reference listed drug, Travatan Z Ophthalmic Solution, 0.004%, of Sandoz Inc. Travoprost ophthalmic solution is used to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

The estimated market size for Travoprost Ophthalmic Solution USP, 0.004%, was US$ 61 million for the twelve months ending September 2025, according to IQVIA.

Alembic Pharmaceuticals has a total of 232 ANDA approvals from the USFDA, comprising 212 final approvals and 20 tentative approvals.

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