USFDA10 Jun 2026, 12:40 pm
Wanbury API Site Passes Australian TGA Quality Inspection
AI Summary
Wanbury Limited's API manufacturing facility in Tanuku, Andhra Pradesh has successfully completed a quality inspection by the Therapeutic Goods Administration (TGA) of Australia. Upon receiving the GMP certificate, the company will be able to ship an additional three APIs. This inspection reaffirms Wanbury's commitment to cGMP compliance and continuous improvement. Separately, another Wanbury API site in Patalganga received a GMP certificate from the Korean FDA (MFDS) following an inspection in April 2026.
Key Highlights
- Australian TGA inspection of Tanuku API site successfully completed.
- GMP certificate will allow shipment of three additional APIs.
- Company reaffirms commitment to cGMP compliance.
- Another site received GMP certificate from Korean FDA.
Price Impact
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