Alembic Pharmaceuticals Ltd

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

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) Ticagrelor Tablets, 60 mg. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Brilinta Tablets, 60 mg, of AstraZeneca Pharmaceuticals LP (AstraZeneca). Ticagrelor tablets are indicated for: i) to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. Ticagrelor tablets also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS. ii) to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events, and iii) to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score 5) or high-risk transient ischemic attack (TIA). Refer label for a detailed indication. Ticagrelor Tablets, 60 mg, have an estimated market size of US$ 236 million for twelve months ending June 2025 according to IQVIA. Alembic had previously received final approval for Ticagrelor Tablets, 90 mg. Powered by Capital Market - Live

The approved ANDA is therapeutically equivalent to the reference listed drug Brilinta Tablets, 60 mg, of AstraZeneca Pharmaceuticals LP. Ticagrelor is indicated to reduce the risk of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome (ACS) or a history of MI, and to reduce the risk of stent thrombosis in patients treated for ACS. It is also used to lower the risk of a first MI or stroke in high-risk coronary artery disease (CAD) patients and to reduce stroke risk in patients with acute ischemic stroke or high-risk transient ischemic attack (TIA). The Ticagrelor 60 mg market in the US is estimated at US$236 million for the 12 months ending June 2025, according to IQVIA. Alembic had earlier received final approval for Ticagrelor 90 mg tablets. With this approval, Alembic now holds a cumulative total of 227 ANDA approvals from the USFDA, including 206 final approvals and 21 tentative approvals. Alembic Pharmaceuticals is a vertically integrated research-driven company that manufactures and markets generic medicines globally. The company's consolidated net profit jumped 14.6% to Rs 154.38 crore while revenue from operations grew 9.54% to Rs 1,710.72 crore in Q1 June 2025 over Q1 June 2024. Shares of Alembic Pharmaceuticals shed 0.29% to Rs 902.70 on the BSE. Powered by Capital Market - Live

Alembic Pharmaceuticals will hold a meeting of the Board of Directors of the Company on 4 November 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) Paroxetine Extended-Release Tablets USP, 25 mg and 37.5 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Paxil CR Extended-Release Tablets, 25 mg and 37.5 mg, of Apotex Inc. Paroxetine Extended-Release Tablets USP, 25 mg and 37.5 mg, are indicated for the treatment of Major depressive disorder (MDD), Panic disorder (PD), Social anxiety disorder (SAD), and Premenstrual dysphoric disorder (PMDD). Refer label for a detailed indication. Powered by Capital Market - Live

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL, marketed by International Medication Systems. Phytonadione Injectable Emulsion is used to treat hypoprothrombinaemia caused by vitamin K deficiency or interference. It is also indicated for the prophylaxis and treatment of vitamin K deficiency bleeding in neonates. For detailed indications, refer to the product label. According to IQVIA, the estimated market size for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL single-dose prefilled syringes, is approximately US$44 million for the twelve months ending June 2025. Alembic Pharmaceuticals is a vertically integrated research-driven company that manufactures and markets generic medicines globally. The company's consolidated net profit jumped 14.6% to Rs 154.38 crore while revenue from operations grew 9.54% to Rs 1,710.72 crore in Q1 June 2025 over Q1 June 2024. Shares of Alembic Pharmaceuticals shed 0.35% to Rs 943.95 on the BSE. Powered by Capital Market - Live