Wanbury Limited has informed the Exchange regarding a press release dated May 12, 2025, titled "Grant of Good Manufacturing Practices Certificate (CBPF) by ANVISA for itsTanuku facility, Andhra Pradesh".
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Wanbury Limited announced that its Tanuku manufacturing facility in Andhra Pradesh has been granted a Good Manufacturing Practices (GMP) Certificate, known as CBPF, by ANVISA, Brazil's national health regulatory agency. The facility cleared an inspection conducted from December 16 to December 20, 2024, with zero observations, confirming strict adherence to current Good Manufacturing Practices (cGMP) standards. The certification covers five active pharmaceutical ingredients (APIs) produced by chemical synthesis: diphenhydramine hydrochloride, metformin hydrochloride, paroxetine hydrochloride hemihydrate, sertraline hydrochloride, and tramadol hydrochloride. The certificate was issued under ANVISA Resolution RE No. 295 dated January 23, 2025, and remains valid until January 27, 2027. This is a key regulatory milestone for Wanbury's pharmaceutical exports business.
This clearance opens the door for Wanbury to supply APIs to the Brazilian pharmaceutical market and reinforces its global manufacturing credibility. For shareholders, it is a positive operational signal that supports export revenue growth and reduces regulatory risk on the company's API business.