Key Announcements

Wanbury Limited announced expanded regulatory submissions for the launch of new Active Pharmaceutical Ingredients (APIs). The company specifically:

  • Submitted Drug Master File (DMF) for Diphenhydramine HCl to regulatory authorities in Malaysia and Singapore
  • Proposed to explore new market opportunities for Paroxetine HCl in Korea and Latin America by submitting DMFs to those markets

Regulatory Compliance Update

The company received a formal audit report from MFDS (Korea Food and Drug Administration) for its Patalganga facility. The audit, conducted in April 2026, resulted in zero observations.

Company Background Context

Wanbury Limited describes itself as a leading pharmaceutical company with a good legacy in domestic and global API markets and branded formulations.