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USFDA Approves Alembic Pharma's Generic Anti-Fungal Solution for Market
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Alembic Pharma gets USFDA nod for generic anti-fungal solution
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News18
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24-02-2026, 18:30
Alembic Pharma gets USFDA nod for generic anti-fungal solution
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Alembic Pharmaceuticals received final approval from the USFDA for Efinaconazole Topical Solution (10 per cent).
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The generic medication is therapeutically equivalent to Bausch Health Americas, Inc.'s Jublia Topical Solution (10 per cent).
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Efinaconazole Topical Solution is used for the topical treatment of onychomycosis of the toenail(s).
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Alembic was among the first ANDA applicants with a paragraph IV certification.
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The estimated market size for Efinaconazole Topical Solution is USD 500 million for the 12 months ending December 2025.
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