Alembic Pharmaceuticals Receives FDA Approval for Efinaconazole

Alembic Pharmaceuticals Limited has announced that it received final approval from the US Food & Drug Administration (FDA) for its efinaconazole topical solution, 10%.

This approval marks a significant achievement for Alembic as the product is now therapeutically equivalent to the reference drug Jublia topical solution, 10%, from Bausch Health Americas, Inc.

Efinaconazole topical solution is indicated for the treatment of onychomycosis of the toenail(s) caused by Trichophyton rubrum and Trichophyton mentagrophytes. With this approval, Alembic joins the ranks of key players in the pharmaceutical industry who are making strides in the dermatology space.

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Alembic was one of the first companies to submit an ANDA with a paragraph IV certification, a step that further emphasizes their commitment to delivering quality, affordable medications to patients. The market for efinaconazole topical solution is estimated to reach US$ 500 million by December 2025, according to IQVIA.

This brings Alembic's total ANDA approvals to 234, including 215 final approvals and 19 tentative approvals from the US FDA. The company has demonstrated its consistent ability to bring competitive generics to market, benefiting both patients and healthcare systems worldwide. Headquartered in India, Alembic Pharmaceuticals has been a key player in the global pharmaceutical market since 1907, manufacturing and marketing generic pharmaceutical products worldwide.