Wanbury Receives ANVISA Approval for Metformin HCl API

Date: November 12, 2026

Regulatory Approval Details

Wanbury Limited has received regulatory approval in the form of a CADIFA (Letter of suitability for API) from ANVISA (Brazil FDA) for its flagship product Metformin HCl EP grade. This approval represents the third consecutive regulatory approval from ANVISA for Wanbury's APIs, which enables customers to use the company's APIs for formulations.

Business Implications

The company states it is committed to meeting customer demands and striving for quality excellence. Following this approval, Wanbury has initiated talks with various customers to increase the volume of business from its customer base.

Disclosure Context

This announcement is made pursuant to Regulation 30 of SEBI LODR (Listing Obligations and Disclosure Requirements). The disclosure serves to inform the exchanges about this significant regulatory development that enables the company to expand its business operations in the Brazilian market.