Lupin Gets China NMPA Nod for Oseltamivir Suspension, Marks Entry into Chinese Market
New Delhi: Lupin Limited has announced that China's National Medical Products Administration (NMPA) has approved its Abbreviated New Drug Application (ANDA) for Oseltamivir Phosphate for Oral Suspension, developed in partnership with Yabao Pharmaceuticals, a major player in China's pediatric medicine segment.
The approval marks Lupin’s first product entry into the Chinese pharmaceutical market, representing a significant milestone in the company’s global expansion strategy.
The approved product, Oseltamivir Phosphate for Oral Suspension 6 mg/mL, will be commercialized in China with a focus on expanding access to influenza treatment and prevention, particularly among pediatric patients.
Oseltamivir Oral Suspension is indicated for:
- Treatment of influenza A and B in patients aged 2 weeks and older
- Prevention of influenza A and B in individuals aged 1 year and older
Commenting on the development, Fabrice Egros, President – Corporate Development, Lupin, said the approval represents a strategic step into one of the world’s largest pharmaceutical markets and reflects the company’s commitment to providing high-quality and affordable therapies, especially in pediatric care.
Wei Ren, President of Yabao Pharmaceuticals, stated that the approval highlights the strength of the collaboration between the two companies and reinforces Yabao’s focus on quality pediatric medicines. He added that the partnership will continue expanding research and development efforts in pediatric and chronic disease therapies.
Headquartered in Mumbai, Lupin operates in more than 100 markets worldwide and has a strong presence across therapy areas including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. The company has 15 manufacturing facilities and seven research centers globally.
