Kolon Life Science, Chungju Plant Obtains Brazil GMP.. Accelerating Entry into Latin America

[Financial News] Kolon Life Science announced on the 24th that its Chungju plant recently obtained GMP certification for the manufacture and quality management of active pharmaceutical ingredients (API) from the Brazilian National Health Surveillance Agency (ANVISA). With this certification, Kolon Life Science has secured the qualification to stably supply API to the Brazilian market.
Brazil's ANVISA operates its GMP regulations based on the World Health Organization (WHO) standards.
The review process includes △ on-site inspection of the manufacturing plant △ document review △ review report and result notification △ publication in the official gazette and issuance of the certificate.
Following its listing as a GMP-certified company in the Brazilian official gazette on the 14th, Kolon Life Science recently received the official certificate, proving once again that the Chungju plant has a global-level manufacturing and quality management system. The certification is valid until July 14, 2027.
The certified item is the hyperlipidemia treatment API 'Pitavastatin Calcium Hydrate'.
Pitavastatin has seen a steady increase in global demand due to the aging population and changes in dietary habits leading to more cardiovascular disease patients.
According to the global market research firm Mordor Intelligence, the global market size of Pitavastatin is expected to reach approximately 917.97 million dollars (about 1.3 trillion won) by 2030, with a compound annual growth rate (CAGR) of 6.01% from 2025 to 2030.
Kolon Life Science has successfully entered the generic markets of Japan, Taiwan, and Europe with Pitavastatin, securing stable sales and profits while building a foundation for growth. Recently, they have improved production efficiency and quality by introducing new manufacturing processes and completing the 'Process Validation' procedure.
With this certification, Kolon Life Science can expand its influence into the global market, including the Latin American region. Kolon Life Science is also working to expand its Pitavastatin supply chain to major global markets such as the United States, China, and Southeast Asia, and the recent Brazil ANVISA GMP certification is expected to be an important stepping stone in this global market entry strategy.
Kim Sun-jin, CEO of Kolon Life Science, said, "This Brazil GMP certification means that the quality and production system of Kolon Life Science's API has been internationally recognized once again," adding, "We will continue to stably supply various APIs, including Pitavastatin, to countries around the world and strengthen cooperation with global partners."

vrdw88@fnnews.com Kang Jung-mo Reporter