Wanbury Limited has informed the Exchange regarding a press release dated May 20, 2025, titled "Grant of Good Manufacturing Practices Certificate (CBPF) by ANVISA, Brazil FDAfor its Patalganga facility, Maharashtra".
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Wanbury Limited has received the Good Manufacturing Practices (CBPF) certificate from ANVISA, Brazil's health regulator, for its Patalganga API manufacturing facility in Maharashtra. The certificate specifically approves the site for manufacturing Metformin Hydrochloride API and is valid until May 12, 2027. ANVISA granted this approval after reviewing the USFDA inspection report and other documents of the site. This is the second ANVISA approval in May 2025 — the Tanuku site in Andhra Pradesh received a similar certificate on May 12, 2025. With this, both of Wanbury's API manufacturing sites are now compliant with Brazilian GMP regulations.
This regulatory approval enables Wanbury to supply Metformin API to the Brazilian pharmaceutical market, opening up export opportunities in a major emerging market. The dual-site ANVISA compliance strengthens the company's credibility for global API exports and could support revenue from regulated markets, though no specific revenue impact or order size has been disclosed.