Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for Levothyroxine Sodium Tablets USP in multiple strengths. The approved Abbreviated New Drug Application (ANDA) is therapeutically equivalent to the reference listed drug product, Synthroid Tablets, marketed by AbbVie, Inc.

USFDA Approval Details

The final approval covers Levothyroxine Sodium Tablets USP in strengths of 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Levothyroxine sodium is indicated as a replacement or adjunct therapy for various forms of hypothyroidism and thyroid cancer.

Market Opportunity

According to IQVIA data, Levothyroxine Sodium Tablets USP have an estimated market size of US$ 1,869 million for the twelve months ending March 2026. This approval allows Alembic Pharmaceuticals to commercialize a product with significant demand in the US market.

Alembic Pharmaceuticals now holds a cumulative total of 239 ANDA approvals from the USFDA, comprising 220 final approvals and 19 tentative approvals.

Alembic Pharmaceuticals has reported its audited standalone and consolidated financial results for the quarter and financial year ended 31st March, 2026. The Board of Directors, at its meeting held on 15th May, 2026, approved the results and recommended a dividend of ₹12 per equity share (face value ₹2 each), representing 600%, for FY26, subject to shareholder approval. This compares to a dividend of ₹11 per equity share declared for FY25. The statutory auditors, M/s. KKC & Associates LLP, Chartered Accountants, have issued an audit report with an unmodified opinion on both the standalone and consolidated audited financial results. The company, with a team size of 17,200+ employees, operates 10 manufacturing facilities and 2 R&D centres, and has cumulatively filed 274 ANDAs with 235 approvals and 178 products commercialised as of 31st March, 2026.

Q4 FY26 Consolidated Financial Performance

For the quarter ended 31st March, 2026, the company reported consolidated revenue from operations of ₹1,847.72 crores (INR 18.48 Bn), compared to ₹1,769.64 crores in the corresponding quarter of the previous year, reflecting 4% year-on-year growth. Consolidated net profit after tax attributable to shareholders stood at ₹202.70 crores, up 29% from ₹156.89 crores in the year-ago quarter. On a sequential basis, profit for the period attributable to shareholders grew 52% quarter-on-quarter. EBITDA pre-R&D increased by 8% year-on-year to ₹455 crores, with a pre-R&D EBITDA margin of 25%. Basic and diluted earnings per share for the quarter rose to ₹10.31 from ₹7.98 year-on-year. R&D expenses stood at 11% of revenue for the quarter, with absolute R&D spend rising 39% year-on-year to INR 2.09 Bn from INR 1.51 Bn in Q4 FY25, driven by one-off peptide development and higher filings.

The table below summarises the key consolidated financial metrics for Q4 FY26:

Segment-Wise Revenue Performance

Across business segments, the quarter saw mixed performance. The India Branded Business delivered 4% year-on-year growth, reaching INR 5.68 Bn in revenue, with the company ranked 21st in the Indian Pharmaceutical Market (IPM) and holding a 1.2% market share. Alembic ranks 17th by prescription volume, recording 136.5 million prescriptions for MAT March 2026, with 2,46,000 prescribers. The US Formulation business grew 11% year-on-year to INR 5.64 Bn, supported by 6 product launches in the quarter. The Ex-US Generics business recorded a de-growth of -2% year-on-year to INR 3.69 Bn, attributed to a higher base effect and one-off variances. The API business grew 2% to INR 3.47 Bn, led by strong volumes, though tempered by pricing challenges. The Animal Health segment was a standout performer, recording 27% year-on-year growth with quarterly revenue of INR 1,241 Mn, driven by its established portfolio in Livestock, Poultry, and Companion Animal segments.

The revenue summary across segments is presented below:

The company also marked its entry into the US Branded Business through Alembic Therapeutics with the launch of Pivya, a first-line oral antibiotic for uncomplicated urinary tract infections in women. In the US, 15 products were launched in FY26, bringing the total number of commercialised products to 178. Cumulatively, 274 ANDA filings have been made, with 235 approvals (including 19 tentative approvals). In Q4 FY26 alone, 5 ANDAs were filed and 4 received approval.

Full-Year FY26 Consolidated Results

For the full financial year ended 31st March, 2026, consolidated revenue from operations stood at ₹7,344.90 crores (INR 73.45 Bn), compared to ₹6,672.08 crores in FY25, reflecting 10% growth. Net profit after tax attributable to shareholders for FY26 came in at ₹674.77 crores, with total comprehensive income at ₹695.69 crores. Full-year basic and diluted EPS was ₹34.33. EBITDA for FY26 stood at INR 11.77 Bn, with an EBITDA margin of 16%. R&D spend for FY26 was INR 7.1 Bn, representing 9.6% of sales. Capital expenditure for FY26 was INR 4.32 Bn. Return on Capital Employed (ROCE) for FY26 stood at 15%.

Standalone Financial Highlights

On a standalone basis, revenue from operations was ₹1,718.74 crores for Q4 FY26, compared to ₹1,570.64 crores in Q4 FY25. Standalone profit after tax for Q4 FY26 came in at ₹243.07 crores, compared to ₹75.34 crores in the corresponding prior-year quarter. For the full year FY26, standalone revenue from operations was ₹6,651.38 crores, with profit after tax at ₹640.42 crores. The standalone net worth as at 31st March, 2026 stood at ₹5,621.34 crores, with a debt-equity ratio of 0.20 times and a current ratio of 1.70 times. The operating margin (EBITDA before exceptional items) for Q4 FY26 stood at 17.45% on a standalone basis.

Exceptional Items

During the quarter and year, two significant exceptional items were recognised. Following the Government of India's notification of the Labour Codes on 21st November 2025, which consolidated twenty-nine existing labour laws and introduced a uniform definition of wages, an incremental impact of ₹6.41 crores for the quarter and ₹48.54 crores for the year was recognised relating to gratuity and long-term compensated absences. Additionally, assets relating to the Sikkim manufacturing facility were classified as held for sale in accordance with Ind AS 105, resulting in a write-down of ₹18.35 crores. The total exceptional charge for the quarter stood at ₹24.76 crores and ₹66.99 crores for the full year. The company also recognised deferred tax assets aggregating to ₹100.27 crores during the quarter, comprising ₹58.46 crores arising from a change in the applicable tax rate and ₹41.81 crores relating to tax credits.

FY27 Business Outlook and Segment Guidance

Management outlined its growth targets for FY27 across key business segments. The company targets low double-digit revenue growth overall for FY27. The international generics business is expected to grow in the low to mid-teen range, while the API business is anticipated to grow in the high single or low double-digit range. The India business is aiming for growth aligned with market trends.

R&D and Capital Expenditure Plans

For FY27, the company projects R&D spending in the range of ₹750 crores to ₹800 crores, aiming for a revenue return of approximately 9%. Capital expenditure for FY27 is estimated at ₹300 crores to ₹350 crores, focused on capacity improvements and replacement.

ESG Commitments

Alembic Pharmaceuticals is one of 10 Indian pharma companies with approved targets under the Science Based Targets initiative (SBTi). The company has set a net zero target by 2050, with interim goals of 63% GHG emission reduction by 2034 and 90% reduction by 2050. On the environmental front, the company has commissioned a 24 MW solar park at Bhatpur, Vadodara, achieved a 20% reduction in specific water consumption, recycled 81% of treated water, and planted 25,000+ trees. The company also recorded zero fatalities and received Great Place to Work certification for the third consecutive year, with 2,44,460 beneficiaries impacted through CSR initiatives.