Wanbury Limited Patalganga Site Achieves Zero Observation in Korea FDA Regulatory Inspection

Wanbury Limited Patalganga Site Achieves Zero Observation in Korea FDA Regulatory Inspection

Wanbury Limited Patalganga Site Achieves Zero Observation in Korea FDA Regulatory Inspection​

Wanbury Limited announced the successful completion of its Patalganga site by the Ministry of Food and Drug Safety (MFDS), which functions as the Korea FDA regulatory body. The inspection, conducted over three days from April 7, 2026, to April 9, 2026, resulted in zero observations, confirming compliance with cGMP standards according to international rules.

The successful MFDS inspection marks a significant regulatory milestone for the company.

Wanbury Limited confirmed that its operational infrastructure remains robust and globally compliant. Both the API manufacturing sites—Patalganga and Tanuku—continue to be compliant with cGMP Rules and Regulations with Zero Observation.

The company noted its strong history of global regulatory approval, including multiple zero observation findings from major international bodies.

For an overview of the key regulatory approvals and outcomes, the data highlights the company's consistent adherence to global quality standards:

SiteRegulatory BodyOutcome
PatalgangaKorea FDA (MFDS)Zero Observation
PatalgangaUSFDAZero Observation (Earlier)
TanukuAnvisa (Brazil FDA)Zero Observation

In terms of future growth and capacity expansion, Wanbury Limited is also strengthening its operational footprint. The company is adding a new state-of-the-art manufacturing block at its Andhra Pradesh site, specifically designed for new APIs. These new APIs are currently undergoing validation and are set for commercialization.

The continued compliance record, spanning successful audits from the USFDA, Anvisa, and the recent zero observation status from the Korea FDA, reinforces Wanbury Limited's position in the pharmaceutical manufacturing sector.

WANBURY Stock Price Movement​

Today, Wanbury Limited shares edged higher to close at ₹259.85, gaining 0.14% in trading. The stock recorded a volume of 17,235 shares during the session, stabilizing above its previous close of ₹259.22.
 

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