Alembic Pharmaceuticals has received approval from 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), Tamiflu Capsules, 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, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. It is also indicated for the prophylaxis of influenza A and B in patients 1 year and older.
According to IQVIA, Oseltamivir Phosphate Capsules has an estimated market size of $ 647 million for twelve months ending December 2018. Alembic now has a total of 97 ANDA approvals (85 final approvals and 12 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
