Wanbury's Patalganga site clears Korea FDA inspection with zero observations

Patalganga plant received zero observation from USFDA earlier

Wanbury Limited has successfully passed a Korea FDA (MFDS) regulatory inspection at its Patalganga API manufacturing facility, achieving zero observations. A team of inspectors conducted the three-day audit from April 7–9, 2026, confirming the site’s strict compliance with global cGMP (current Good Manufacturing Practices) standards. 

MFDS is part of PIC (Pharmaceutical inspection co-operation scheme). The company is strengthening infrastructure by adding new state of the art manufacturing block at Andhra Pradesh site for new APIs which under validation and commercialisation. 

Both the API manufacturing sites are USFDA approved i.e. Patalganga and Tanuku of WL are continued to be compliant as per cGMP Rules and Regulations with Zero Observation. 

Patalganga plant received zero observation from USFDA earlier. Thereafter, Tanuku plant received Zero Observation from Anvisa (Brazil FDA). Now again, Patalganga plant got Korea FDA Approval with Zero Observation.