
Business Update8 Oct 2026, 01:06 pm
Wanbury Files DMF in South Africa for Tramadol HCl API
AI Summary
Wanbury Limited has announced the filing of a new Drug Master File (DMF) in South Africa for its Tramadol HCl API. Additionally, the company filed DMFs in the Philippines and Singapore for Metformin HCl API to cater to customer demands. Wanbury also strengthened its supply chain by adding new Key Starting Material (KSM) vendors for its CEP-filed API, Paroxetine HCl, and received approval from the European Directorate for the Quality of Medicines and Health (EDQM). Furthermore, the Therapeutic Goods Administration (TGA) accepted the compliance report for inspectional observations, allowing continued supply of APIs to Australia.
Key Highlights
- Filed new DMF in South Africa for Tramadol HCl API.
- Filed DMFs in Philippines and Singapore for Metformin HCl API.
- Secured EDQM approval for Paroxetine HCl API supply chain.
- TGA accepted compliance report for Australian market supply.
Price Impact
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