Yuhan Chemical completes FDA and ANVISA inspections

Yuhan Chemical has confirmed its capacity for global-scale manufacturing and quality management systems

With a newly built second manufacturing plant in Hwaseong and upcoming new orders, Yuhan Chemical hopes to secure a foundation for future growth

Yuhan Chemical’s manufacturing plant in Hwaseong.

Yuhan Chemical (CEO & President: Sang-Hun Seo) has confirmed its global-scale capacity for manufacturing and quality management systems.

 

Yuhan Chemical announced on the 5th that the company has successfully completed the inspections of the United States Food and Drug Associations (FDA) and the Brazilian Health Surveillance Agency (ANVISA).

 

As a result, the current inspection likely verified that Yuhan Chemical has the global-scale capacity for manufacturing and quality management systems, firmly establishing its position as Korea’s top active pharmaceutical ingredient (API) manufacturing company.

 

The current FDA inspection lasted five days, serving as a Pre-Approval Inspection and a routine inspection for APIs intended for U.S.

 

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The FDA assessed the company’s compliance with stringent good manufacturing practice (cGMP) standards, and the inspection successfully concluded with only minor notifications issued.

 

Yuhan Chemical also cleared Pre-Approval Inspection of Brazil’s ANVISA, known to be as stringent as the FDA approval, with no observations.

 

Regarding the current inspections, Yuhan Chemical stated, “This round of inspections reaffirmed that Yuhan Chemical holds a strong position as an API company.

 

We have demonstrated our superior manufacturing facility, quality system, and commitment to Data Integrity, utilizing an IT-based quality system while upholding the company’s values of honesty and integrity.” Yuhan Chemical, a subsidiary of Yuhan Corporation, is an API development and manufacturing company.

 

Founded in July 1980, the company has been pursuing global quality standards.

 

Yuhan Chemical received FDA approval for its Ansan manufacturing plant in 2002 and is certified to comply with the advanced GMP quality standards of regulatory agencies in various countries, including European EDQM, Japanese PMDA, Brazil ANVISA, and Australia TGA.

 

In January 2016, the company established its second plant in Hwaseong, Gyeonggi Province.

 

To expand its manufacturing capacity to achieve further growth, Yuhan Chemical completed the construction of a new facility, HB Dong, in November 2023.

 

The facility has the capacity to produce 144,000 liters annually.

 

With these developments, Yuhan Chemical has a total production capacity of 843,000 liters annually.

 

The company expects to secure new contracts with potential clients with its expanded manufacturing capacity.

 

With scheduled inspections by regulatory agencies and client companies, Yuhan Chemical aims to achieve high-quality growth and further development.

 

“Yuhan Chemical is strengthening its competitive position in producing top-quality APIs.

 

Our company is actively working to implement a Continuous Manufacturing system, which will become a new industry standard worldwide,” Yuhan Chemical stated.

 

“Yuhan Chemical aims to overcome the difficulties posed by the diminishing domestic API manufacturing landscape due to low price competitiveness.

 

The company will strive to become a global API CDMO leader.”