Lupin Limited has received NMPA approval for oseltamivir phosphate oral suspension in China, its first commercial launch in the market. Developed with Yabao Pharmaceuticals, the antiviral targets pediatric influenza care and expands Lupin’s Asia-Pacific footprint.
By: Regulatory Desk
Global pharmaceutical company Lupin Limited has received approval from China’s National Medical Products Administration (NMPA) for oseltamivir phosphate oral suspension (6 mg/mL), developed in partnership with Yabao Pharmaceuticals. The antiviral is indicated for the treatment of influenza A and B in patients as young as two weeks, and for prophylaxis in individuals aged one year and older.
Mechanism and Historical Context
Oseltamivir phosphate is a neuraminidase inhibitor that blocks the release of influenza viruses from infected host cells, limiting viral spread within the respiratory tract. The drug gained global prominence during the 2009 H1N1 “swine flu” pandemic, when it was deployed as a frontline therapy to reduce influenza-related complications and transmission. Its oral suspension formulation remains particularly important in pediatric care, offering a practical treatment option for children unable to swallow tablets or capsules.
Market Expansion
The approval marks Lupin’s first commercial launch in China and underscores its expansion into the Asia-Pacific pharmaceutical market. Seasonal influenza continues to pose a significant public health burden, and demand for accessible antiviral formulations has increased across the region following recurrent outbreaks and heightened respiratory virus surveillance after COVID-19.
Strategic Collaboration
The partnership combines Lupin’s manufacturing and formulation expertise with Yabao’s established commercialization infrastructure in China’s pediatric medicine market.
Fabrice Egros, President of Corporate Development at Lupin, said the approval represents “a strategic step into one of the world’s largest pharmaceutical markets” and reinforces the company’s focus on expanding access to affordable therapies.
Yabao President Wei Ren added that the approval strengthens the partnership and supports future expansion of their R&D portfolio across pediatric and adult chronic disease therapies.
Commercial Pathway
Commercialization in China will follow regulatory clearance, providing Lupin with a pathway for additional product registrations and long-term market expansion in the region. The approval also positions the Lupin–Yabao alliance to broaden its footprint in pediatric and chronic disease therapies, aligning with regional healthcare priorities.
Reference
Lupin Receives China Approval for Oseltamivir Phosphate Oral Suspension – Lupin | Press Release
