Company Disclosure: USFDA Drug Approval
Product Details
The approved product is therapeutically equivalent to the reference listed drug product (RLD), Tamiflu Oral Suspension, 6 mg/mL, manufactured by Hoffmann-La Roche, Inc.
Therapeutic Indications
Oseltamivir Phosphate is an influenza neuraminidase inhibitor (NAI) indicated for:
- 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
- Prophylaxis of influenza A and B in patients 1 year and older
Market Size
The product has an estimated market size of US$ 27 million for the twelve months ending March 2026, according to IQVIA data.
Company Background
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in India, operating since 1907. The company manufactures and markets generic pharmaceutical products globally with USFDA-approved facilities and maintains a field force of over 5,500 for branded generics in India.