Alembic Pharmaceuticals Ltd

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

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) Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL, of International Medication Systems (International). Phytonadione Injectable Emulsion is indicated for the treatment of hypoprothrombinemia due to vitamin K deficiency or interference. It is also indicated for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates. Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe, have an estimated market size of US$ 44 million for twelve months ending June 2025 according to IQVIA. Powered by Capital Market - Live

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Opsumit tablets, 10 mg, of Actelion Pharmaceuticals US, Inc. (Actelion). Macitentan tablets are an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults to reduce the risks of disease progression and hospitalization for PAH. Macitentan tablets, 10 mg, have an estimated market size of $1,180 million for twelve months ending June 2025 according to IQVIA. The pharmaceutical company has a cumulative total of 224 ANDA approvals (203 final approvals and 21 tentative approvals) from USFDA. 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.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) Tretinoin Cream USP, 0.025%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Retin-A Cream, 0.025%, of Bausch Health US, LLC. Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. Tretinoin cream USP, 0.025%, has an estimated market size of US$ 94 million for twelve months ending June 2025 according to IQVIA. Powered by Capital Market - Live

The product is therapeutically equivalent to Bausch Health's Retin-A Cream, 0.025%, and is indicated for the topical treatment of acne vulgaris. The cream has an estimated market size of $94 million for the 12 months ended June 2025, according to IQVIA. With this nod, Alembic's cumulative ANDA approvals now stand at 224, including 202 final and 22 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 14.18% to Rs 156.63 crore while revenue from operations grew 9.54% to Rs 1,710.72 crore in Q1 June 2025 over Q1 June 2024. Powered by Capital Market - Live

Net profit of Alembic Pharmaceuticals rose 14.60% to Rs 154.38 crore in the quarter ended June 2025 as against Rs 134.71 crore during the previous quarter ended June 2024. Sales rose 9.54% to Rs 1710.72 crore in the quarter ended June 2025 as against Rs 1561.73 crore during the previous quarter ended June 2024. ParticularsQuarter EndedJun. 2025Jun. 2024% Var. Sales1710.721561.73 10 OPM %16.4215.16 - PBDT263.88226.07 17 PBT190.11157.03 21 NP154.38134.71 15 Powered by Capital Market - Live

Revenue from operations grew 9.54% year on year (YoY) to Rs 1,710.72 crore in the quarter ended 30 June 2025. Profit before tax (PBT) was at Rs 190.10 crore in Q1 FY26, up 21.05% from Rs 157.03 crore recorded in the corresponding quarter previous year. EBIDTA grew 20% YoY to Rs 288 crore while EBIDTA margin stood at 17% during the period under review. The India Branded Business recorded a 5% year-on-year growth, generating ₹599 crore in revenue during the quarter. Specialty Therapies, including Gynaecology, Cardiology, Anti-Diabetic, Ophthalmology, and Animal Healthcare segments, demonstrated strong momentum. Additionally, the Anti-infective and Cough & Cold segments matched market performance, supported by robust operational execution. The company also introduced three new products in this period. In the International Business segment, US Generics revenue grew 13% to Rs 523 crore, backed by four product launches. Ex-US International Generics reported a 21% increase, reaching Rs 328 crore. The company secured six ANDA approvals this quarter, bringing the cumulative total to 223. The API business experienced modest growth of 1%, with revenues at Rs 261 crore for the quarter. Pranav Amin MD, Alembic Pharmaceuticals, said, 'we began FY26 on a strong note, delivering revenue growth across all businesses. The growth was driven by a 21% increase in RoW markets, reflecting our strategic expansion and disciplined execution across geographies. Despite ongoing pricing pressure, our US business grew by 13%, supported by volume gains. As we ramp up utilization of our new manufacturing facilities and continue to drive cost optimization initiatives, we expect to benefit from improved operating leverage.' 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. Shares of Alembic Pharmaceuticals fell 1.57% to Rs 952.10 on the BSE. 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) Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tegretol-XR Extended Release Tablets, 100 mg, 200 mg, and 400 mg, of Novartis Pharmaceuticals Corporation. Carbamazepine Extended-Release Tablets are indicated for use as an anticonvulsant drug and also for the treatment of the pain associated with true trigeminal neuralgia. Refer label for a detailed indication. Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg, have an estimated market size of US$ 71 million for twelve months ending March 2025 according to IQVIA. Alembic has a cumulative total of 225 ANDA approvals (202 final approvals and 23 tentative approvals) from USFDA.Powered by Capital Market - Live

Alembic Pharmaceuticals will hold a meeting of the Board of Directors of the Company on 5 August 2025.Powered by Capital Market - Live

Alembic Pharmaceuticals has appointed Dr. Sachin Ghosalkar is appointed as Sr. Vice President - SCM & Operations (Senior Management Personnel) of the Company w.e.f. 21 July 2025. Powered by Capital Market - Live