Alembic Pharma gets USFDA nod to market generic anti-fungal solution

New Delhi: Alembic Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market generic antifungal medication.

The company has received final approval from the US Food & Drug Administration (USFDA) for Efinaconazole Topical Solution (10 per cent).

The approved abbreviated new drug application (ANDA) is therapeutically equivalent to Bausch Health Americas, Inc's Jublia Topical Solution (10 per cent)


Efinaconazole Topical Solution is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.

Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification, the drug firm said in a statement.

According to IQVIA, Efinaconazole Topical Solution has an estimated market size of USD 500 million for 12 months ended December 2025.

Alembic shares on Tuesday ended 2.69 per cent down at Rs 750.15 apiece on BSE.