Alembic Pharmaceuticals has received approvalfrom the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application(ANDA) Oseltamivir Phosphate Capsules USP, 30 mg (base), 45 mg (base) and 75 mg (base).The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), TamifluCapsules, 30 mg (base), 45 mg (base) and 75 mg (base), of Hoffman-La Roche, Inc.Oseltamivir Phosphate Capsules USP are indicated for the treatment of acute, uncomplicatedillness due to influenza A and B infection in patients 2 weeks of age and older who have beensymptomatic for no more than 48 hours. It is also indicated for the prophylaxis of influenza Aand B in patients 1 year and older.

Oseltamivir Phosphate Capsules has an estimated market size of US$ 647 million for twelvemonths ending December 2018 according to IQVIA.

Alembic now has a total of 97 ANDA approvals (85 final approvals and 12 tentative approvals)from USFDA.