Alembic Pharmaceuticals Ltd. has obtained final approval from the U.S. Food and Drug Administration for its generic version of Difluprednate Ophthalmic Emulsion, 0.05%, strengthening its presence in regulated markets and adding to its growing suite of approved drug products.
The approval covers an Abbreviated New Drug Application (ANDA) that is therapeutically equivalent to the reference listed drug Durezol ophthalmic emulsion marketed by Sandoz Inc., a corticosteroid formulation commonly used to manage inflammation and pain following ocular surgery and to treat endogenous anterior uveitis, an inflammatory eye disorder.
The latest FDA clearance, announced on January 27, 2026, brings Alembic’s cumulative count of U.S. ANDA approvals to 233, comprising 213 final and 20 tentative approvals, reflecting consistent regulatory execution across diverse therapeutic categories.
This extensive approval record underpins Alembic’s strategy of building scale in the U.S. generics market, a key revenue driver for many Indian pharmaceutical exporters.
Difluprednate belongs to a class of corticosteroid eye treatments that have been used in the United States for over a decade to address postoperative inflammation and pain, with the reference branded product approved as long ago as 2008. These drugs play a niche but stable role in the ophthalmic segment, where combinations of efficacy and safety are critical for surgical recovery and chronic inflammatory conditions.
Alembic’s approvals in recent years have spanned multiple therapeutic areas, including ophthalmology, oncology and cardiovascular care, demonstrating the company’s ability to navigate complex regulatory pathways and diversify its offerings. For example, in 2025 it received FDA clearance for a generic doxorubicin liposome injection indicated in cancer care, and earlier approvals have included treatments for acid reflux and other systemic conditions.
The U.S. generics segment remains a cornerstone of Alembic’s international business, with regulators granting ANDA approvals that enable the company to market cost-effective alternatives to established branded therapies.
This latest clearance is expected to facilitate product launches in the U.S. market later in the year once commercial preparations are completed, contributing to sales and reinforcing the company’s competitive footprint in ophthalmic and broader therapeutic categories.
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