Wanbury's Tanuku API site passes TGA quality inspection; Korean FDA GMP cert received
Wanbury Limited's Tanuku API manufacturing site successfully passed a quality inspection by Australia's TGA. This enables the shipment of three additional APIs upon receiving the GMP certificate. Additionally, the Patalganga site received a GMP certificate from the Korean FDA.
The successful inspections and potential for shipping additional APIs are positive for business growth, but the direct financial impact is not quantified in the announcement. The expansion into new regulatory markets is significant.
The successful completion of quality inspections by two major regulatory bodies (TGA and MFDS) is a positive development for the company, potentially opening up new markets and expanding its product reach.
Wanbury Limited announced that its Active Pharmaceutical Ingredient (API) manufacturing site located in Tanuku, Andhra Pradesh, has successfully completed a quality inspection conducted by the Therapeutic Goods Administration (TGA), Australia's drug regulatory agency.
Upon receipt of the GMP certificate from TGA, Wanbury will be enabled to ship an additional three APIs. The company reiterated its commitment to cGMP compliance and continuous improvement.
Furthermore, Wanbury's Patalganga site has received a GMP certificate from the MFDS (Korean FDA) following an inspection conducted in April 2026.
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