Alembic Pharmaceuticals Secures USFDA Approval for Eye Drug

Alembic Pharmaceuticals Ltd has secured final approval from US FDA for their Abbreviated New Drug Application (ANDA) for Difluprednate Ophthalmic Emulsion, 0.05%.

This signifies yet another accomplishment by the Indian pharmaceutical manufacturer and strengthens the company's position within the regulated US generic pharmaceutical sector. The approved drug is therapeutically equivalent to Durezol Ophthalmic Emulsion, 0.05% marketed by Sandoz Inc., and allows Alembic to enter into the US generics market.

Difluprednate Ophthalmic Emulsion can be prescribed for relief of pain after ocular surgery or treatment of endogenous anterior uveitis. Additional dosing and usage instructions will be included in the product labeling approved by the US Food and Drug Administration (FDA). The approval of this drug will allow Alembic to expand its Ophthalmology portfolio within the US.

Also Read: Advancing Interventional Radiology in India Through Collaboration

With the addition of Difluprednate Ophthalmic Emulsion, Alembic has received a total of 233 USFDA ANDA approvals, which consist of 213 final and 20 tentative approvals. This shows that the company continues to execute its plans successfully for compliance-driven development and meets the high standards set forth by the US regulatory agencies.

Alembic Pharmaceuticals Limited is one of the oldest pharmaceutical companies in India, having been founded in 1907, and it is based in India. The company is vertically integrated and produces a number of research and development programs, all over the world, that focus on the development, manufacture and sale of high-quality generic pharmaceuticals that cover many different therapeutic classes.

A core strength of Alembic Pharmaceuticals lies in its sustained focus on research and development, supported by modern infrastructure and a robust product pipeline for both regulated and emerging markets. Its manufacturing facilities are approved by leading global regulators, including the USFDA, reinforcing its reputation as a reliable partner to healthcare systems worldwide.