Alembic Pharmaceuticals Limited has achieved a significant regulatory milestone with the receipt of final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Carbidopa, Levodopa and Entacapone tablets. This approval represents another step forward in the company's expansion within the competitive US pharmaceutical market.

Product Details and Therapeutic Equivalence

The approved formulation includes multiple strength combinations: 12.5 mg/50 mg/200 mg, 18.75 mg/75 mg/200 mg, 25 mg/100 mg/200 mg, 31.25 mg/125 mg/200 mg, 37.5 mg/150 mg/200 mg, and 50 mg/200 mg/200 mg. The approved ANDA has been determined to be therapeutically equivalent to Stalevo tablets of Orion Corporation, which are commonly prescribed for the treatment of Parkinson's disease.

Regulatory Achievement Milestone

This latest approval brings Alembic Pharmaceuticals' total number of ANDA approvals from the USFDA to 234, comprising 214 final approvals and 20 tentative approvals. This substantial portfolio of approved generic drug applications demonstrates the company's consistent ability to meet stringent regulatory requirements and successfully navigate the complex approval process for pharmaceutical products in the United States.

Market Implications

The approval for this Parkinson's disease treatment adds to Alembic Pharmaceuticals' growing portfolio of generic medications in the US market. Generic versions of established treatments like Stalevo provide patients with more affordable alternatives while maintaining the same therapeutic efficacy as the original branded products. The combination of Carbidopa, Levodopa and Entacapone works synergistically to manage the symptoms of this neurological condition.

Company Profile

Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company with a legacy dating back to 1907. Headquartered in India, the publicly listed company manufactures and markets generic pharmaceutical products globally. The company's state-of-the-art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA, and it operates as one of the leaders in branded generics in India with a field force of over 5,500 professionals.

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.