Alembic Pharmaceuticals has announced its Q3FY26 financial results for the quarter ended December 31, 2025, demonstrating robust revenue growth of 11% alongside strong operational performance across all business segments. The pharmaceutical company delivered consistent execution and maintained healthy margins despite recognizing a one-time provision under new labour codes. The company has also outlined strategic expansion plans for injectables and oncology products.

Strong Financial Performance in Q3FY26

The company achieved consolidated revenue from operations of ₹1,876 crore compared to ₹1,693 crore in Q3FY25, representing a growth of 11%. EBITDA increased by 14% to ₹308 crore with EBITDA margin maintained at 16% of revenue. Profit Before Exceptional Items and Tax increased by 15% to ₹205 crore, demonstrating strong operational efficiency.

Strategic Expansion in Injectables and Oncology

Alembic Pharma has outlined plans for new agreements to increase production capacity for injectables and oncology products over the next year and a half. The company expects more opportunities in this segment to materialize within two years, indicating a strategic focus on high-value therapeutic areas.

U.S. Market Strategy and Product Pipeline

The company's U.S. business aims for 10% to 12% growth in the full year and could reach mid-teens growth of 10% to 15% in the next two to three years. US Generics business grew by 6% to ₹553 crore with 2 launches in the US market during the quarter. The company plans to launch 4 to 5 more products in the U.S. in Q4, accelerating its market presence.

Pivya Launch Timeline and Branded Strategy

Alembic Pharma will release its first U.S. branded product, Pivya, in February 2026. This represents a significant milestone in the company's strategy to expand its footprint in branded drugs in the U.S. market. The branded product launch is anticipated to increase script and market share over the coming 12 to 18 months.

Segment-wise Business Performance

The India Branded Business delivered 6% year-over-year growth, reaching ₹652 crore in revenue for the quarter. The Ex-US International Generics segment demonstrated exceptional performance with 36% growth to ₹406 crore. The company received 7 ANDA approvals during the quarter, bringing cumulative ANDA approvals to 232.

R&D Investment and Future Outlook

Alembic Pharmaceuticals has projected full-year R&D expenses between ₹600 to 650 crore. The company expects next year's R&D spending to be around 8% to 9% of total revenue, indicating continued commitment to innovation and pipeline development. The company recognized a one-time provision of ₹42 crore towards employee benefits under new labour codes.

Alembic Pharmaceuticals has achieved a significant regulatory milestone with the receipt of USFDA final approval for Difluprednate Ophthalmic Emulsion, 0.05%. This approval marks another important step in the company's expansion within the US pharmaceutical market.

Product Details and Market Significance

The approved product serves as a generic equivalent to Durezol Ophthalmic Emulsion, expanding Alembic Pharmaceuticals' presence in the ophthalmic therapeutics segment. Difluprednate is a topical corticosteroid used for treating inflammation and pain associated with ocular surgery.

Regulatory Achievement

This latest USFDA approval brings Alembic Pharmaceuticals' total count of Abbreviated New Drug Application (ANDA) approvals from the US Food and Drug Administration to 233. This milestone demonstrates the company's consistent regulatory compliance and successful navigation of the complex USFDA approval process.

Strategic Impact

The approval strengthens Alembic Pharmaceuticals' generic drug portfolio in the United States market. With 233 ANDA approvals now in its portfolio, the company continues to build its presence across various therapeutic segments, including the specialized ophthalmic market segment.