FilingReader Intelligence

Xinhua Pharma secures key drug registration for Oseltamivir Phosphate

December 23, 2025 at 08:50 AM UTCBy FilingReader AI

Shandong Xinhua Pharmaceutical Company Limited announced on December 23, 2025, that it has obtained a Drug Registration Certificate from the National Medical Products Administration for its Oseltamivir Phosphate for Suspension. This oral suspension, a Class 3 chemical and over-the-counter drug, treats and prevents influenza A and B in patients two weeks and older. The product has a specification of 0.36g and was assigned certificate number 2025S03820.

The application materials for this product were submitted in March 2024 to the Center for Drug Evaluation of the State Drug Administration. The December 2025 registration approval is expected to enrich Xinhua Pharmaceutical’s antiviral drug product line and enhance its comprehensive competitiveness. This product is also listed as a Category B product in the "National Drug Catalogue for Basic Medical Insurance, Work Related-Injury Insurance, and Maternity Insurance (2024)."

According to the announcement, sales of Oseltamivir Phosphate for Suspension in China's public medical institutions amounted to approximately RMB 5.9 bn in 2024. The company acknowledges that its pharmaceutical sales business is subject to market dynamics, policy changes, and bidding processes, advising investors to exercise caution due to inherent investment risks.

This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com

News Alerts

Get instant email alerts when Shandong Xinhua Pharmaceutical publishes news

Free account required • Unsubscribe anytime

Filing Activity Timeline

View Complete Filing History →