Indian global pharma giant on 22 May, though a press release has announced that the company has received the China’s National Medical Products Administration’s (NMPA) approval of Abbreviated New Drug Application (ANDA) for its Oseltamivir Phosphate Oral Suspension, in partnership with Yabao Pharmaceuticals, a leader in China’s paediatric medicine market.
The Oseltamivir Phosphate oral suspension, 6 mg/mL will be launched and commercialized to expand access, particularly for paediatric use.
Oseltamivir Phosphate for oral suspension, 6 mg (base)/mL can be used. For treatment of influenza A and B in patients 2 weeks of age and older and prevention of influenza A and B in individuals 1 year of age and older.
Yabao Pharmaceutical Co. is a Beijing, China based leading Chinese pharmaceutical company with fully integrated development, manufacturing, and commercialization in China. Yabao has a well-established business in modern traditional Chinese medicines and chemical generics. Alongside companies strong clinical and regulatory capabilities, Yabao has strong capabilities in formulation and API production thatmeets good manufacturing practice (cGMP) requirements with two manufacturing sites approved by U.S. FDA and a European agency.
This entry marks as a significant milestone for Lupin, as it is the first product to entered into the China. This expands Lupin’s global footprint and its commitment to delivering high-quality, affordable medicines to patients and children in need.
Written by Pramit Hazra
