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Pharmaceuticals
Regulatory28 Apr 2026, 06:01 pm

Wanbury's Patalganga site gets Korea FDA approval with zero observation

AI Summary

Wanbury Limited's Patalganga manufacturing site successfully completed a regulatory inspection by the MFDS (Ministry of Food and Drug Safety - Korea FDA) from April 7-9, 2026. The inspection concluded with "zero observation," confirming the site's compliance with cGMP rules and international standards. This marks another significant regulatory success for Wanbury, as its Patalganga and Tanuku API manufacturing sites are already USFDA approved, with Patalganga previously receiving zero observation from USFDA and Tanuku from Anvisa (Brazil FDA). The company is also expanding its infrastructure with a new manufacturing block in Andhra Pradesh for new APIs.

Key Highlights

  • Wanbury's Patalganga site cleared Korea FDA inspection with zero observation.
  • Inspection confirms cGMP compliance per international rules.
  • Patalganga and Tanuku sites are already USFDA approved with zero observations.
  • Company is strengthening infrastructure with a new manufacturing block.
WANBURY
Pharmaceuticals
WANBURY LTD.

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