Nanchang Baiji Pharmaceutical Co. Ltd., a Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) for its generic budesonide nasal spray. The product is indicated for the treatment of seasonal and perennial allergic rhinitis, as well as perennial non-allergic rhinitis, and for the prevention of nasal polyp regeneration after nasal polypectomy, addressing these conditions symptomatically. This approval also signifies that the product has passed the Generic Quality Consistency Evaluation (GQCE).
Budesonide, a glucocorticoid with anti-inflammatory properties, is widely used to treat asthma and chronic bronchitis. The originator product, developed by UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN), comes in various forms including nasal spray, inhaled aerosol, inhaled powder spray, and inhaled suspension, with the nasal spray being recommended as a first-line treatment for allergic rhinitis. The originator budesonide nasal spray was granted marketing approval in China in 2004, and Baiji Pharma’s product is the first generic to secure marketing approval and pass the GQCE in the country.- Flcube.com
