Alembic Pharmaceuticals has achieved a significant regulatory milestone with the United States Food and Drug Administration (USFDA) granting final approval for its Efinaconazole Topical Solution, 10%. The company announced this development through an official press release and regulatory filing, marking an important expansion of its product portfolio in the US pharmaceutical market.

Product Details and Market Equivalence

The approved Efinaconazole Topical Solution, 10% serves as a generic equivalent to Jublia Topical Solution, 10%, manufactured by Bausch Health Americas, Inc. This regulatory clearance enables Alembic Pharmaceuticals to manufacture and market the topical solution across the United States. The solution is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.

Regulatory Achievement and Market Position

Alembic was one of the first ANDA applicants to submit a substantially complete Abbreviated New Drug Application with a paragraph IV certification for this product. The Efinaconazole Topical Solution, 10%, has an estimated market size of US$ 500 million for twelve months ending December 2025 according to IQVIA data.

Company's USFDA Portfolio Expansion

With this latest approval, Alembic Pharmaceuticals now holds a cumulative total of 234 ANDA approvals from the USFDA. This portfolio comprises 215 final approvals and 19 tentative approvals, demonstrating the company's consistent regulatory success in the US market.

Strategic Significance

The USFDA approval represents a key achievement in Alembic Pharmaceuticals' strategy to expand its presence in the US generics market. By securing approval for a product equivalent to an established brand like Jublia, the company positions itself to capture market share in the antifungal topical treatment category. This regulatory success demonstrates the company's capability to develop and gain approval for complex topical formulations, potentially opening doors for similar product developments in the future.

Alembic Pharmaceuticals Limited announced its unaudited financial results for the quarter and nine months ended 31st December, 2025, showcasing steady growth across key financial metrics. The pharmaceutical company's Board of Directors approved the results at a meeting held on 5th February, 2026, along with a significant board appointment. The company has also fulfilled its regulatory obligations by publishing the results in leading newspapers on 6th February, 2026.

Financial Performance Overview

The company delivered robust performance in Q3FY26 with consolidated revenue from operations reaching Rs 1,876.31 crore, marking a 10.8% year-on-year growth from Rs 1,692.74 crore in Q3FY25. However, this represented a slight sequential decline from Rs 1,910.15 crore in Q2FY26.

Standalone Performance Highlights

The standalone financial results showed strong growth momentum with income from operations reaching Rs 1,642.24 crore in Q3FY26 compared to Rs 1,406.09 crore in the corresponding quarter of the previous year. Profit after tax on standalone basis stood at Rs 114.47 crore versus Rs 85.81 crore in Q3FY25.

Nine-Month Performance

For the nine-month period ended 31st December, 2025, the company demonstrated strong momentum with consolidated revenue of Rs 5,497.18 crore, representing a 12.1% increase from Rs 4,902.45 crore in the corresponding period of the previous year. Net profit for the nine-month period stood at Rs 472.07 crore compared to Rs 426.53 crore in the same period last year, reflecting a 10.7% growth.

Exceptional Items Impact

The company's Q3FY26 results were affected by an exceptional item of Rs 42.23 crore related to the implementation of new Labour Codes. On 21 November 2025, the Government of India notified provisions of Labour Codes that consolidate twenty-nine existing labour laws. This resulted in an incremental impact relating to gratuity and long-term compensated absences arising from the revised definition of wages.

Board Appointment and Regulatory Compliance

Based on the recommendation of the Nomination and Remuneration Committee, the Board appointed Mr. Rajkumar Baheti (DIN: 00332079) as Non-Executive Non-Independent Director, liable to retire by rotation. His appointment will be effective from 1st April, 2026, upon completing his tenure as Executive Director on 31st March, 2026, subject to shareholder approval through postal ballot.

The company has complied with SEBI listing regulations by publishing extracts of its unaudited financial results in Economic Times & Indian Express (English Edition) and Financial Express (Gujarati Edition) on 6th February, 2026. Company Secretary Manisha Saraf submitted the intimation to both BSE and NSE regarding the newspaper publication.