Wanbury Ltd Secures EDQM Approval for Rivaroxaban API, USFDA DMF Clearances

Wanbury Limited has announced significant regulatory milestones. The company received approval from the European Directorate for the Quality of Medicines and Healthcare (EDQM) for its new product, Rivaroxaban API. This approval will allow Wanbury to meet customer demands within the EU and other countries that accept CEP (Certificate of Suitability to the monographs of the European Pharmacopoeia). Additionally, Wanbury has obtained Drug Master File (DMF) clearances from the US Food and Drug Administration (USFDA) for Paraxetine HCI and Metformin HCI. The company is also undergoing ANDA (Abbreviated New Drug Application) reviews for multiple customers, indicating further growth prospects in international markets.