Alembic Pharmaceuticals Ltd

Alembic Pharmaceuticals announced that Prashant Khandelwal, Head-International Business Formulations, has resigned from the said position and relieved w.e.f. 1 December 2025 after closure of business hours.Powered by Capital Market - Live

The approval covers strengths of 30 mg, 60 mg, 90 mg and 120 mg. The product is the generic version of Cardizem, sold by Bausch Health. The medicine is used to manage chronic stable angina and angina caused by coronary artery spasm. Alembic said this approval adds to its strong US portfolio. The company now has 230 ANDA approvals. These include 210 final and 20 tentative approvals. Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. The company's consolidated net profit jumped 20.40% to Rs 184.71 crore in Q2 FY26, compared to Rs 153.41 crore posted in Q2 FY25. Revenue from operations grew 15.90% year on year (YoY) to Rs 1,910.15 crore in Q2 September 2025. Powered by Capital Market - Live

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) Diltiazem Hydrochloride Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Cardizem Tablets, 30 mg, 60 mg, 90 mg, and 120 mg, of Bausch Health US, LLC. Diltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm. Alembic has a cumulative total of 230 ANDA approvals (210 final approvals and 20 tentative approvals) from USFDA. Powered by Capital Market - Live

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Cardizem Tablets of Bausch Health US, LLC. Diltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm. Alembic has a cumulative total of 230 ANDA approvals (210 final approvals and 20 tentative approvals) from USFDA. 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. The company's consolidated net profit jumped 20.40% to Rs 184.71 crore in Q2 FY26, compared to Rs 153.41 crore posted in Q2 FY25. Revenue from operations grew 15.90% year on year (YoY) to Rs 1,910.15 crore in the quarter ended 30 September 2025. The scrip had fallen 1.58% to end at Rs 902.80 on the BSE yesterday. Powered by Capital Market - Live

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Dexilant Delayed-Release Capsules, 30 mg and 60 mg, of Takeda Pharmaceuticals USA, Inc. (Takeda). Dexlansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for use in patients 12 years of age and older for the healing of all grades of erosive esophagitis (EE), the maintenance of healed EE and relief of heartburn, as well as the treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). Dexlansoprazole Delayed-Release Capsules (30 mg and 60 mg) have an estimated market size of $285 million for the twelve months ending September 2025, according to IQVIA. With this approval, Alembic now holds a cumulative total of 229 ANDA approvals (including 209 final approvals and 20 tentative approvals) from the USFDA. 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. The company's consolidated net profit jumped 20.40% to Rs 184.71 crore in Q2 FY26, compared to Rs 153.41 crore posted in Q2 FY25. Revenue from operations grew 15.90% year on year (YoY) to Rs 1,910.15 crore in the quarter ended 30 September 2025. The counter rose 0.53% to currently trade at Rs 922 on the BSE. Powered by Capital Market - Live

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Sumatriptan Injection USP, 4 mg/0.5 mL and 6 mg/0.5 mL, Single-Dose Autoinjector System. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Imitrex STATdose System, 4 mg/0.5 mL and 6 mg/0.5 mL, of GlaxoSmithKline Intellectual Property Ltd. England. Sumatriptan injection is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. Refer label for a detailed indication. This is Alembic's first drug device combination product. Sumatriptan Injection USP, 4 mg/0.5 mL and 6 mg/0.5 mL, Single-Dose Autoinjector System, have an estimated market size of US$ 73 million for twelve months ending September 2025 according to IQVIA.Powered by Capital Market - Live

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) Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, of Bristol-Myers Squibb Company (BMS). Dasatinib tablets are indicated for the treatment of adult patients with: (i) newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, (ii) chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib, (iii) Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are also indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. Refer label for a detailed indication. Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, have an estimated market size of US$ 1,017 million for twelve months ending September 2025 according to IQVIA. Powered by Capital Market - Live

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets, of Bristol-Myers Squibb Company (BMS). Dasatinib is indicated for adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib, and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. It is also approved for pediatric patients aged one year and above with Ph+ CML in chronic phase. According to IQVIA, Dasatinib tablets have an estimated market size of US$ 1,017 million for the 12 months ending September 2025. With this approval, Alembic has a cumulative total of 227 ANDA approvals from the USFDA, including 207 final approvals and 20 tentative approvals. 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. The company's consolidated net profit jumped 20.40% to Rs 184.71 crore in Q2 FY26, compared to Rs 153.41 crore posted in Q2 FY25. Revenue from operations grew 15.90% year on year (YoY) to Rs 1,910.15 crore in the quarter ended 30 September 2025. Shares of Alembic Pharmaceuticals rose 0.16% to currently trade at Rs 917 on the BSE. Powered by Capital Market - Live

Revenue from operations grew 15.90% year on year (YoY) to Rs 1,910.15 crore in the quarter ended 30 September 2025. Profit before tax (PBT) stood at Rs 223.72 crore, up 23.99% from Rs 180.42 crore recorded in the same quarter last year. EBITDA rose 26% YoY to Rs 325 crore, while the EBITDA margin improved to 17% during the period under review. In the India Branded Business, revenue grew 5% YoY to Rs 639 crore. The Gynaecology, Ophthalmology, and Animal Healthcare segments demonstrated accelerating performance, while the Cough & Cold segment grew in line with market performance, supported by robust operational execution. The company also introduced two new products during the quarter. In the International Business, US Generics revenue rose 21% YoY to Rs 566 crore, supported by three product launches in the US market. Ex-US International Generics grew 31% YoY to Rs 392 crore, with six ANDA approvals received during the quarter, taking cumulative ANDA approvals to 226. The API business reported a 15% YoY increase in revenue to Rs 261 crore for the quarter. Shaunak Amin MD, Alembic Pharmaceuticals, said, 'Our Q2 performance reflects continued momentum in our core businesses and the disciplined execution. We have strengthened our presence across key markets while maintaining a sharp focus on profitability and operational excellence, delivering an overall growth of 16% and pre-R&D EBITDA margin of 26%. Our R&D investment, at around 10% of revenue, reflects our commitment to building a strong pipeline for future growth. We continue to focus on complex and high-value areas such as injectables, peptides, oral solids, and drug discovery. During the quarter, we completed the acquisition of Utility Therapeutics that provides a segway in to branded drugs in the US. 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

Net profit of Alembic Pharmaceuticals rose 20.40% to Rs 184.71 crore in the quarter ended September 2025 as against Rs 153.41 crore during the previous quarter ended September 2024. Sales rose 15.91% to Rs 1910.15 crore in the quarter ended September 2025 as against Rs 1647.98 crore during the previous quarter ended September 2024. ParticularsQuarter EndedSep. 2025Sep. 2024% Var. Sales1910.151647.98 16 OPM %16.5314.52 - PBDT299.79238.06 26 PBT223.72167.55 34 NP184.71153.41 20 Powered by Capital Market - Live