Alembic Pharmaceuticals Ltd. on Friday, June 26, said it has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Oseltamivir Phosphate for Oral Suspension, 6 mg/mL.
With this, Alembic Pharmaceuticals’ cumulative USFDA approvals stand at 243 ANDAs, comprising 223 final approvals and 20 tentative approvals.
The approved product is the generic equivalent of Hoffmann-La Roche’s Tamiflu Oral Suspension, 6 mg/mL, used for the treatment of acute, uncomplicated influenza A and B in patients aged two weeks and older, as well as for the prevention of influenza A and B in patients aged one year and above.
According to IQVIA data, the product has an estimated US market size of $27 million for the 12 months ended March 2026, the company said.
Shares of Alembic Pharmaceuticals closed at ₹771.50 apiece on Thursday, June 25, down 1.17% for the day.
(Edited by : Tenzin Norzom)
First Published: Jun 26, 2026 2:28 PM IST
