Lupin secures first China NMPA approval with Oseltamivir launch

CHINA—Lupin Limited has secured approval from China’s National Medical Products Administration for its Abbreviated New Drug Application for Oseltamivir Phosphate oral suspension, developed in collaboration with Yabao Pharmaceuticals.

The decision marks Lupin’s first regulatory entry into China, opening access to one of the world’s largest pharmaceutical markets and strengthening its global expansion strategy.

The approval comes as both companies continue to focus on broadening access to essential antiviral therapies, particularly in pediatric healthcare.

The product will be manufactured and commercialized to support treatment and prevention needs during influenza seasons, with an emphasis on improving availability for younger patients across China.

Product profile and clinical application

Oseltamivir Phosphate oral suspension, formulated at 6 mg/mL, is indicated for the treatment of influenza A and B infections in patients aged two weeks and older.

In addition, it is approved for the prevention of influenza A and B in individuals aged one year and above.

The oral suspension format is designed to improve dosing flexibility, especially for children and patients who may have difficulty swallowing capsules or tablets.

By introducing this formulation into the Chinese market, Lupin aims to address gaps in pediatric antiviral access while aligning with broader public health efforts to manage seasonal influenza burden.

The company has continued to expand its respiratory and antiviral portfolio globally, with this approval reinforcing its focus on essential medicines that serve both preventive and therapeutic needs.

Leadership perspectives on the approval

Fabrice Egros, President of Corporate Development at Lupin Limited, noted that the approval represents a key strategic step for the company as it enters China’s pharmaceutical sector.

He emphasized that the development reflects a shared commitment with Yabao Pharmaceuticals to improving access to high-quality and affordable treatments, particularly for pediatric patients who require tailored formulations.

He further stated that Lupin expects to strengthen its presence in China through continued collaboration and market development initiatives with its local partner.

Wei Ren, President of Yabao Pharmaceuticals, said the regulatory approval marks an important milestone in the company’s collaboration with Lupin.

He highlighted that the achievement supports Yabao’s ongoing focus on quality pediatric medicines while reinforcing its broader research and development strategy.

He added that the partnership will continue to expand its pipeline across both pediatric and adult therapies, with a focus on chronic disease and infectious conditions, as both companies work to advance their combined capabilities in the Chinese healthcare market.