Alembic Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (U.S. FDA) for its abbreviated new drug application (ANDA) for the antifungal drug Efinaconazole Topical Solution, 10%.
The approved ANDA is therapeutically equivalent to Jublia Topical Solution, 10%, of Bausch Health Americas, Inc.
Market Impact & Indication: Alembic was one of the first applicants to submit a substantially complete ANDA with a paragraph IV certification. Efinaconazole Topical Solution, 10% had an estimated market size of $500 million for the 12 months ending December 2025, the company said citing IQVIA numbers. The drug is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.
About Alembic Pharmaceuticals
Alembic Pharmaceuticals is an Indian multinational pharmaceutical company headquartered in Vadodara, Gujarat. The company manufactures and markets pharmaceutical products, including active pharmaceutical ingredients (APIs) and formulations, and has a presence in the macrolide anti-infective drug segment.
Alembic Pharmaceuticals produces formulations for therapeutic areas such as cardiology, dermatology, diabetes, ophthalmology, and infectious diseases for domestic and international markets. It operates manufacturing facilities in Gujarat (Panelav and Karakhadi), Sikkim, and Pithampur as well as research and development centres in India and the United States.
