Alembic Pharmaceuticals Ltd

Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Levothyroxine Sodium Tablets USP, 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. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Synthroid Tablets, 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, of AbbVie, Inc. (AbbVie). Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

Alembic Pharmaceuticals announced that the Board of Directors of the Company at its meeting held on 15 May 2026, inter alia, have recommended the final dividend of Rs 12 per equity Share (i.e. 600%) , subject to the approval of the shareholders.

Net profit of Alembic Pharmaceuticals rose 29.20% to Rs 202.70 crore in the quarter ended March 2026 as against Rs 156.89 crore during the previous quarter ended March 2025. Sales rose 4.41% to Rs 1847.72 crore in the quarter ended March 2026 as against Rs 1769.64 crore during the previous quarter ended March 2025. For the full year,net profit rose 15.66% to Rs 674.77 crore in the year ended March 2026 as against Rs 583.42 crore during the previous year ended March 2025. Sales rose 10.08% to Rs 7344.90 crore in the year ended March 2026 as against Rs 6672.08 crore during the previous year ended March 2025. ParticularsQuarter EndedYear EndedMar. 2026Mar. 2025% Var.Mar. 2026Mar. 2025% Var. Sales1847.721769.64 4 7344.906672.08 10 OPM %12.3415.33 -15.2315.11 - PBDT231.97260.93 -11 1079.49972.89 11 PBT143.38191.94 -25 760.94694.31 10 NP202.70156.89 29 674.77583.42 16 Powered by Capital Market - Live

Revenue from operations grew 4.41% year on year (YoY) to Rs 1,847.72 crore in the quarter ended 31 March 2026. Profit before tax (PBT) stood at Rs 118.62 crore in Q4 FY26, up 38.20% from Rs 191.95 crore recorded in the same quarter last year. EBITDA pre R&D increased by 8% year-on-year to Rs 455 crore, while the pre R&D EBITDA margin stood at 25% during the period under review. India Branded Business posted a 4% year-on-year growth, with revenue reaching Rs 568 crore in the quarter. The performance was supported by steady traction across key therapeutic areas, with gynaecology, gastroenterology, ophthalmology and animal healthcare segments delivering encouraging momentum during the period. The company also strengthened its portfolio with the introduction of two new products during the quarter. International Business posted a steady performance during the quarter, with US formulations growing 11% year-on-year to Rs 564 crore. The segment also witnessed strong pipeline expansion with six product launches in the US market. Ex-US generics contributed Rs 369 crore in revenue, while the company received four ANDA approvals during the quarter, further strengthening its future product portfolio and growth visibility. The API business recorded a 2% year-on-year growth, with revenue rising to Rs 347 crore during the quarter, reflecting stable performance in the segment. The company marked its entry into the US branded pharmaceuticals market during the quarter with the launch of its branded business through Alembic Therapeutics, its step-down wholly owned subsidiary. The debut offering, Pivya, was commercially launched as part of the company's strategy to build a focused branded specialty portfolio in the US market. Pivya' is positioned as a first-line oral antibiotic for the treatment of uncomplicated urinary tract infections (uUTIs) in women, addressing a segment that has seen limited innovation and new product introductions for over a decade, thereby offering a clinically established therapy with a well-defined safety and efficacy profile. Pranav Amin, Managing Director, Alembic Pharmaceuticals, said, 'Q4FY26 reflects disciplined execution across our businesses, supported by continued focus on profitability, operational delivery and long-term growth investments. We delivered revenue growth across key segments while maintaining healthy pre-R&D operating margins. During the quarter, we marked our entry into the Branded Business in the US, beginning with the launch of Pivya, opening a new avenue for long-term value creation.' The company has recommended a dividend of Rs 12 per equity share of face value Rs 2 each, representing a 600% dividend for the financial year ended March 31, 2026. Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA. Powered by Capital Market - Live

Alembic Pharmaceuticals has received an Establishment Inspection Report (EIR) from the USFDA, for its Injectable facility (F-III) located at Karakhadi on 13 May 2026. The USFDA inspection was conducted from 9 February 2026 to 18 February 2026.

Alembic Pharmaceuticals (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Darolutamide Tablets, 300 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Nubeqa Tablets, 300 mg, of Bayer HealthCare Pharmaceuticals Inc. (Bayer). Darolutamide is an androgen receptor inhibitor indicated for the treatment of adult patients with: i) non-metastatic castration-resistant prostate cancer (nmCRPC), ii) metastatic castration-sensitive prostate cancer (mCSPC), and iii) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel. Refer label for a detailed indication.

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Nubeqa Tablets, 300 mg, marketed by Bayer HealthCare Pharmaceuticals. Darolutamide is an androgen receptor inhibitor indicated for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC), metastatic castration-sensitive prostate cancer (mCSPC), and mCSPC in combination with docetaxel. According to IQVIA, Darolutamide Tablets, 300 mg, have an estimated market size of US$ 3,155 million for the 12 months ended March 2026. With this approval, Alembic Pharmaceuticals now has a cumulative total of 238 ANDA approvals from the USFDA, comprising 219 final approvals and 19 tentative approvals. Alembic Pharmaceuticals is a vertically integrated research and development company engaged in the manufacture and marketing of generic pharmaceutical products across global markets. The company had reported a 3.9% decline in consolidated net profit to Rs 132.97 crore despite a 10.8% increase in net sales to Rs 1,876.31 crore in Q3 FY26 compared with Q3 FY25. Powered by Capital Market - Live

Alembic Pharmaceuticals will hold a meeting of the Board of Directors of the Company on 15 May 2026.

Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fingolimod Capsules, 0.5 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Gilenya Capsules, 0.5 mg of Novartis Pharmaceuticals Corporation (Novartis). Fingolimod is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in patients 10 years of age and older. Fingolimod Capsules, 0.5 mg, have an estimated market size of US$ 145 million for twelve months ending December 2025 according to IQVIA.

The newly formed entity, Alembic Lifesciences Philippines Inc., will focus on exploring business opportunities in the region and promoting, selling, and distributing the company's pharmaceutical products. The company holds a 99.99% stake in the subsidiary. Alembic Lifesciences Philippines Inc. has an authorised share capital of 12 million Philippine pesos, divided into 1.2 million shares of 10 Philippine pesos each. Alembic Pharmaceuticals, a vertically integrated research and development company, is engaged in the manufacture and marketing of generic pharmaceutical products across global markets. The company's consolidated net profit fell 3.9% to Rs 132.97 crore despite a 10.8% jump in net sales to Rs 1,876.31 crore in Q3 FY26 over Q3 FY25.