Alembic Pharma Share Price in Focus; Receives USFDA Final Approval for Efinaconazole Topical Solution, 10%

Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration (USFDA) for Efinaconazole Topical Solution, 10%, marking another addition to its regulated market portfolio. 

The approval strengthens the company’s presence in the US generics segment and reflects its continued focus on expanding specialised therapeutic offerings through regulatory filings.

USFDA Approval for Efinaconazole Topical Solution

The company announced that the USFDA has granted final approval for its Abbreviated New Drug Application (ANDA) for Efinaconazole Topical Solution, 10%. The product is therapeutically equivalent to the reference listed drug, Jublia Topical Solution, developed by Bausch Health Americas, Inc.

The medication is used for the topical treatment of onychomycosis, a fungal infection affecting toenails caused by specific dermatophyte fungi. The approval allows Alembic to market the product in the United States following regulatory clearance.

Market Opportunity and Regulatory Position

Alembic was among the early applicants to submit a substantially complete ANDA with a Paragraph IV certification for the product. 

According to industry estimates, the treatment recorded an approximate market size of US$500 million for the twelve months ending December 2025, indicating a measurable commercial opportunity in the US dermatology segment.

With this development, Alembic Pharmaceuticals’ cumulative USFDA approvals have reached 234, including 215 final approvals and 19 tentative approvals.

Company Overview and Global Presence

Alembic Pharmaceuticals is a vertically integrated research-driven pharmaceutical company engaged in the development, manufacturing, and marketing of generic medicines across global markets.

The company operates manufacturing and research facilities approved by multiple international regulatory authorities, including the USFDA, and maintains a significant presence in branded generics within India.

Its product portfolio is supported by a large field force and a diversified therapeutic pipeline aimed at both domestic and international markets.

Alembic Pharmaceuticals Share Price Performance

Shares of Alembic Pharmaceuticals traded lower during the session following the announcement. The stock was quoted at ₹759.85, declining by ₹9.50 or 1.23% compared with the previous close of ₹769.35.

The stock opened at ₹765.00 and moved within an intraday range of ₹751.00 to ₹767.00, reflecting moderate trading activity during the session.

Read More:Aurobindo Pharma Share Price Rebounds 3% After Clarification on USFDA Inspection.

Conclusion

The USFDA approval for Efinaconazole Topical Solution adds to Alembic Pharmaceuticals’ expanding portfolio in regulated markets and reinforces its ongoing regulatory filing strategy. 

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