Korea’s Kolon Life Science said Thursday that its facility for producing active pharmaceutical ingredients in Chungju, a city in the country’s central region, has secured Good Manufacturing Practice (GMP) certification from Brazil’s National Health Surveillance Agency (ANVISA), allowing the company to begin exports to the Brazilian market.

ANVISA’s review process, based on World Health Organization standards, includes an on-site inspection, document review, and public notice in Brazil’s official gazette, the government’s legal journal of record.

Kolon was listed in the gazette on July 14 and has now received its formal certificate, confirming that its facility meets global standards for manufacturing and quality control. The certification is valid through July 14, 2027.

The approved product is pitavastatin calcium hydrate, used to treat hyperlipidemia, a condition characterized by high levels of fat in the blood that can lead to cardiovascular disease. 

Kolon said it has already established a stable revenue base for pitavastatin in generic markets across Korea, Japan, Taiwan, and Europe. 

With the Brazilian approval, Kolon is targeting broader international expansion starting with Latin America. The company said it is also working to extend its supply network to the United States, China, and Southeast Asia, positioning the ANVISA certification as a key step in its global strategy.