Alembic Pharma Secures USFDA Approval for Generic Influenza Oral Suspension
Approval for generic version of Tamiflu oral suspension expands Alembic's US portfolio; product addresses an estimated US$27 million market
Alembic Pharmaceuticals has secured final USFDA approval for its generic Oseltamivir Phosphate Oral Suspension, expanding its portfolio of approved generic medicines in the United States.
Mumbai: Alembic Pharmaceuticals 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, strengthening the company’s presence in the US generic pharmaceuticals market.
The approved product is therapeutically equivalent to Tamiflu Oral Suspension, 6 mg/mL, marketed by Hoffmann-La Roche Inc., and is indicated for the treatment and prevention of influenza A and B infections.
According to the company, the oral suspension is approved for the treatment of acute, uncomplicated influenza A and B in patients aged two weeks and older who have experienced symptoms for no more than 48 hours. It is also approved for the prevention of influenza A and B in individuals aged one year and above, subject to the approved prescribing information.
Expanding US Generics Portfolio
Market research firm IQVIA estimates that the US market for Oseltamivir Phosphate Oral Suspension, 6 mg/mL was worth approximately US$27 million during the 12 months ending March 2026, presenting a new commercial opportunity for Alembic in the respiratory therapeutics segment.
With the latest approval, Alembic has now secured a cumulative 243 ANDA approvals from the USFDA, comprising 223 final approvals and 20 tentative approvals, reflecting its continued focus on expanding its regulated market portfolio.
Strengthening Global Presence
Founded in 1907, Alembic Pharmaceuticals is one of India’s leading pharmaceutical companies with vertically integrated research, development and manufacturing operations. The company manufactures and markets generic pharmaceutical products across global markets, with manufacturing facilities approved by major international regulatory agencies, including the USFDA.
The latest approval reinforces the growing role of Indian pharmaceutical manufacturers in supplying high-quality, affordable generic medicines to regulated global markets while strengthening India’s position as a major pharmaceutical manufacturing hub.
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