ALEMBIC PHARMACEUTICALS LTD : RECEIVES USFDA FINAL APPROVAL FOR OSELTAMIVIR PHOSPHATE

• Alembic Pharmaceuticals Limited announces 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 treatment and prophylaxis of influenza A and B. • The market size for Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, is estimated at US$ 27 million for twelve months ending March 2026. • Alembic has a cumulative total of 243 ANDA approvals from USFDA (223 final approvals and 20 tentative approvals).

Alembic Pharmaceuticals Limited

Open attachment

← Back to feed