Date: August 13, 2026
Regulatory Approvals Summary
Wanbury Limited has received significant regulatory approvals for its pharmaceutical products:
EDQM Approval
- Received approval from the European Directorate for the Quality of Medicines and Healthcare (EDQM)
- Approval granted for new product Rivaroxaban API (Active Pharmaceutical Ingredient)
- This approval enables the company to meet customer demand in the European Union
- Also facilitates supply to other countries that accept Certificate of Suitability (CEP) approvals
USFDA Clearances
- Received Drug Master File (DMF) clearance for Paroxetine HCl from USFDA
- Received Drug Master File (DMF) clearance for Metformin HCl from USFDA
- These clearances support Abbreviated New Drug Application (ANDA) reviews for multiple customers
Strategic Implications
The regulatory approvals represent significant milestones that:
- Expand market access to regulated markets including EU and US
- Support customer ANDA applications through DMF clearances
- Enhance the company's product portfolio with additional approved APIs
- Strengthen regulatory compliance capabilities for international markets
These developments position Wanbury to better serve global pharmaceutical customers requiring approved API sources for their drug applications.