Regulatory Inspection Outcome
Wanbury Limited's Active Pharmaceutical Ingredient (API) manufacturing facility located in Tanuku, Andhra Pradesh, has successfully completed a quality inspection conducted by the Therapeutic Goods Administration (TGA). The TGA is the drug regulatory agency of Australia.
Strategic and Operational Impact
The successful inspection is a prerequisite for receiving a Good Manufacturing Practice (GMP) certificate. Upon formal receipt of this certificate, Wanbury will be enabled to ship an additional three (3) APIs to markets that recognize Australian TGA approvals. This development represents a potential expansion of the company's addressable market and product portfolio for regulated markets.
Compliance Status and Other Site Update
The company states that it continues to remain in compliance with current Good Manufacturing Practices (cGMP) and is committed to continual improvement.
In a related update, Wanbury's other API manufacturing site, located in Patalganga, has received a GMP certificate from the Ministry of Food and Drug Safety (MFDS), which is the Korean FDA. This certification follows an inspection that was conducted at the Patalganga site in April 2026.