Alembic Pharmaceuticals announced on February 24, 2026, that it has secured the USFDA Final Approval for its Abbreviated New Drug Application (ANDA) for Efinaconazole Topical Solution, 10%. This product is therapeutically equivalent to Jublia Topical Solution (Bausch) and treats onychomycosis. The estimated market size for this formulation is projected to be US$ 500 million annually.
Alembic Secures USFDA Final Approval
Alembic Pharmaceuticals Limited confirmed today, 24th February, 2026, that it has received the Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Efinaconazole Topical Solution, 10%.
Product Details and Therapeutic Use
The approved ANDA is considered therapeutically equivalent to the reference listed drug product, Jublia Topical Solution, 10%, previously marketed by Bausch Health Americas, Inc. (Bausch). Efinaconazole Topical Solution, 10%, is indicated for the topical treatment of onychomycosis of the toenail(s) caused by Trichophyton rubrum and Trichophyton mentagrophytes.
Market Potential and Regulatory Milestone
Alembic highlighted that it was among the first ANDA applicants to submit a substantially complete ANDA supported by a paragraph IV certification. According to IQVIA data, the estimated market size for this Efinaconazole Topical Solution, 10%, for the twelve months ending December 2025 stands at US$ 500 million.
With this recent clearance, Alembic now possesses a cumulative total of 234 ANDA approvals from the USFDA, consisting of 215 final approvals and 19 tentative approvals.
Company Background
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company with a history dating back to 1907. The company manufactures and markets generic pharmaceutical products globally, supported by state-of-the-art research and manufacturing facilities approved by major international regulatory bodies, including the USFDA.
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