Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration for its Abbreviated New Drug Application for Oseltamivir Phosphate for Oral Suspension, 6 mg/mL. The USFDA approval was announced on June 26, 2026.
The approved ANDA is therapeutically equivalent to the reference listed drug product, Tamiflu Oral Suspension, 6 mg/mL, of Hoffmann-La Roche, Inc. Oseltamivir Phosphate is an influenza neuraminidase inhibitor indicated for treatment of acute, uncomplicated influenza A and B in patients two weeks of age and older who have been symptomatic for no more than 48 hours. The drug is also indicated for prophylaxis of influenza A and B in patients one year and older.
Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, has an estimated market size of US$ 27 million for the twelve months ending March 2026, per IQVIA data. The oral suspension formulation provides an antiviral treatment and prevention option for influenza, particularly for patients who require a liquid dosage form. Oseltamivir is a well-established antiviral medication used during influenza seasons for both treatment and prevention.
Alembic Pharmaceuticals has a cumulative total of 243 ANDA approvals from the USFDA, comprising 223 final approvals and 20 tentative approvals. Alembic continues to add new product approvals in the US generics market across multiple therapeutic categories.
Alembic, headquartered in Vadodara, India, has been in operation since 1907. Alembic is a vertically integrated research and development pharmaceutical company with manufacturing facilities approved by regulatory authorities including the USFDA. Alembic markets its products across global markets.
Disclaimer: This article is based on company filings submitted to the Bombay Stock Exchange (BSE) and National Stock Exchange of India (NSE) and is for informational purposes only. It does not constitute investment advice or a recommendation. Investors should conduct their own research and consult a qualified financial advisor before making investment decisions.