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Alembic Pharma Secures US FDA Approval for Loteprednol Etabonate & Tobramycin Ophthalmic Suspension

12 Dec 2025
Admin
News Article

Alembic Pharma Secures US FDA Approval for Loteprednol Etabonate & Tobramycin Ophthalmic Suspension

Alembic Pharmaceuticals has added another milestone to its US generics portfolio. The company received final approval from the US FDA for its loteprednol etabonate and tobramycin ophthalmic suspension (0.5%/0.3%). This approval strengthens Alembic’s position in the global ophthalmic care segment.

What the Approval Covers?

The FDA approval clears Alembic’s Abbreviated New Drug Application (ANDA) for the product in 5 mL and 10 mL presentations.
The formulation is:

Therapeutically equivalent to Zylet, the reference ophthalmic suspension from Bausch & Lomb.
Indicated for steroid-responsive inflammatory eye conditions, especially where bacterial infection exists or may occur.
Designed to combine anti-inflammatory action with antimicrobial protection.

Competitive Generic Therapy (CGT) Advantage

Alembic earned a Competitive Generic Therapy (CGT) designation for this product.
This comes with a major commercial benefit:

Alembic will gain 180 days of CGT exclusivity once the product is launched.
The exclusivity period can significantly enhance early market traction.
CGT approvals usually reflect limited competition within that drug category.

A Strong Track Record in ANDA Approvals

This approval adds to Alembic’s expanding US portfolio. The company now holds:

231 total ANDA approvals
211 final approvals
20 tentative approvals

These numbers highlight Alembic’s consistent R&D strength and regulatory execution.

About Alembic Pharmaceuticals

Alembic is a vertically integrated Indian pharmaceutical company with over a century of expertise. Key strengths include:

A strong global footprint.
Robust R&D capabilities.
A diversified generics portfolio across therapeutic segments.

Alembic continues to build its US pipeline with complex, high-value products—cementing its position as a reliable global pharma partner.