Alembic Pharmaceuticals Receives USFDA Final Approval For Efinaconazole Topical Solution, 10%

Alembic Pharmaceuticals Ltd announced that it has secured final approval from the USFDA for its Efinaconazole Topical Solution, 10%. The product is indicated for the topical treatment of onychomycosis of the toenails caused by Trichophyton rubrum and Trichophyton mentagrophytes. This milestone follows earlier tentative approval and marks a significant addition to Alembic’s growing dermatology pipeline.  

Key Highlights 

• USFDA grants final approval for Alembic’s Efinaconazole Topical Solution, 10%  
• Therapeutically equivalent to reference drug Jublia by Bausch Health  
• Indicated for treatment of toenail fungal infections (onychomycosis)  
• Approval strengthens Alembic’s dermatology and specialty portfolio in the US  
• Company now holds over 140 ANDA approvals, including 123 final approvals  

Strategic Impact  
The final approval for Efinaconazole Topical Solution enhances Alembic’s position in the US generics market, particularly in dermatology. Analysts note that the product offers a cost-effective alternative to branded therapies, potentially boosting Alembic’s revenues and market share. The development underscores Alembic’s strong R&D capabilities and its commitment to expanding its global footprint in specialty pharmaceuticals.  

Sources: Medical Dialogues, MoneyControl, BSE Filings