26th June, 2026 Vadodara, India
2026-06-01 · Alembic Pharmaceuticals Ltd. · original alembicpharmaceuticals.com ↗
ALEMBIC PHARMACEUTICALS LIMITED REGD. OFFICE: ALEMBIC ROAD, VADODARA - 390 003. ● TEL: (0265) 2280550, 2280880 ● FAX: (0265) 2281229 Website : www.alembicpharmaceuticals.com ● E-mail : [email protected] ● CIN : L24230GJ2010PLC061123 PRESS RELEASE 26th June, 2026 Vadodara, India Alembic Pharmaceuticals Limited announces USFDA Final Approval for Oseltamivir Phosphate for Oral Suspension, 6 mg/mL. Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Oseltamivir Phosphate for Oral Suspension, 6 mg/mL. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tamiflu Oral Suspension, 6 mg/mL, of Hoffmann-La Roche, Inc. Oseltamivir Phosphate is an influenza neuraminidase inhibitor (NAI) indicated for: i) treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours, and ii) Prophylaxis of influenza A and B in patients 1 year and older. Refer label for a detailed indication. Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, have an estimated market size of US$ 27 million for twelve months ending March 2026 according to IQVIA. Alembic has a cumulative total of 243 ANDA approvals (223 final approvals and 20 tentative approvals) from USFDA. About Alembic Pharmaceuticals Limited Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leaders in branded generics in India. Alembic's brands, marketed through a field force of over 5500 are well recognized by doctors and patients. Information about the Company can be found at www.alembicpharmaceuticals.com; (Reuters:ALEM.NS) (Bloomberg:ALPM) (NSE:APLLTD) (BSE:533573) For more information, contact: Ajay Kumar Desai Phone: +91 22-66953681 Email: [email protected]
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