- USFDA grants final approval for Oseltamivir Phosphate for Oral Suspension, expanding Alembic Pharmaceuticals’ respiratory and anti-infective product portfolio in the United States
- Generic version of Roche’s Tamiflu targets an estimated US$27-million market and is indicated for the treatment and prevention of Influenza A and B
- Latest clearance takes Alembic’s cumulative USFDA approvals to 243 ANDAs, underscoring the company’s growing global regulatory and manufacturing capabilities
NE BUSINESS BUREAU
MUMBAI, JUNE 29
Alembic Pharmaceuticals Limited has further strengthened its presence in the highly regulated US pharmaceutical market after securing 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.
The approved product is the therapeutically equivalent generic version of Tamiflu Oral Suspension, 6 mg/mL, marketed by Hoffmann-La Roche Inc., and is expected to expand Alembic’s portfolio in the anti-infective and respiratory therapy segments.
Oseltamivir Phosphate, a widely prescribed influenza neuraminidase inhibitor (NAI), is indicated for the treatment of acute, uncomplicated Influenza A and B in patients aged two weeks and above who have been symptomatic for not more than 48 hours. It is also approved for the prophylaxis (prevention) of Influenza A and B in individuals aged one year and above, as detailed in the product label.
According to IQVIA, the US market for Oseltamivir Phosphate for Oral Suspension, 6 mg/mL recorded an estimated value of US$27 million during the twelve-month period ending March 2026, presenting a significant commercial opportunity for the company.
The latest approval further reinforces Alembic Pharmaceuticals’ robust regulatory track record in the United States. With this milestone, the company now holds 243 cumulative ANDA approvals from the USFDA, comprising 223 final approvals and 20 tentative approvals.
The approval reflects Alembic’s continued focus on expanding its global generic medicines portfolio through strong research, regulatory compliance and advanced manufacturing capabilities, while enhancing access to affordable, high-quality medicines in international markets.
