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Ankit Gupta

12th Nov · SEBI Registration INH100007231

Wanbury Secures Third Consecutive ANVISA Approval

WANBURY LIMITED: Wanbury Limited has received regulatory approval from Brazil's National Health Surveillance Agency (ANVISA), also known as Brazil's FDA, for its flagship product, Metformin HCl EP Grade API. The approval has been granted through a CADIFA (Letter of Suitability for API), marking the company's third consecutive regulatory approval from ANVISA. This regulatory milestone strengthens Wanbury's position in the Brazilian pharmaceutical market and enables its customers to use the company's approved API in their pharmaceutical formulations. The approval is particularly relevant for the company's active pharmaceutical ingredients (API) business, as regulatory . With this third consecutive approval, Wanbury continues to build its regulatory track record with the Brazilian authority. The company has also stated that it remains committed to meeting customer requirements and maintaining quality standards across its product portfolio. Following the approval, Wanbury has initiated discussions with various customers to increase business volumes. These discussions are aimed at expanding the commercial opportunity for its Metformin HCl EP Grade API and potentially increasing customer demand in the Brazilian market. However, the company has not disclosed any confirmed additional order value or specific volume commitments at this stage. Market participants may track the progress of customer discussions, subsequent commercial arrangements and the potential impact of the approval on the company's API business. Overall, the third consecutive ANVISA approval represents an important regulatory and business development for Wanbury Limited, supporting its efforts to expand customer opportunities and increase business volumes. This information is shared strictly as a corporate and market update for informational purposes and should not be considered investment advice, research analysis, or a recommendation to buy or sell any security.

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