Wanbury Ltd Secures EDQM Approval for Rivaroxaban API, USFDA DMF Clearances
Wanbury Limited received EDQM approval for Rivaroxaban API, enabling supply to EU countries. The company also obtained USFDA DMF clearance for Paraxetine HCI and Metformin HCI, and is undergoing ANDA reviews for multiple customers.
The approvals for Rivaroxaban API, Paraxetine HCI, and Metformin HCI are likely to boost the company's product portfolio and market presence, potentially leading to increased revenue and market share in the pharmaceutical sector.
The company has received significant regulatory approvals from EDQM and USFDA for its key products, which is a positive development for its business expansion and market reach.
Wanbury Limited has announced significant regulatory approvals for its key products. The company has received approval from the European Directorate for the Quality of Medicines and Healthcare (EDQM) for its new product, Rivaroxaban API. This approval is expected to enhance the company's ability to meet customer demand in the European Union and other countries that accept Certificates of Suitability to the European Pharmacopoeia (CEP).
In addition to the EDQM approval, Wanbury Limited has also secured DMF (Drug Master File) clearance from the U.S. 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.
These regulatory milestones are crucial for Wanbury Limited's expansion and market penetration in key international markets.
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Wanbury Limited filed this with the NSE as a statutory disclosure, categorised under product launches. It is a primary document, not a recommendation, and the desk marks it medium impact: worth reading, rarely worth acting on by itself.
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