Kolon Life Science Secures Foothold in Latin America, Strengthening Global Competitiveness

▷ Chungju Plant reaffirms global manufacturing and quality capabilities for ‘Pitavastatin' through Brazilian GMP certification

▷ Accelerates supply chain enhancement to expand into global markets including the US, China, and Southeast Asia 

Kolon Life Science (CEO Kim Sun-jin) announced on the 24th that its Chungju Plant had recently obtained Good Manufacturing Practice (GMP) certification for Active Pharmaceutical Ingredient (API) manufacturing and quality control from Brazil's National Health Surveillance Agency (ANVISA). This certification qualifies Kolon Life Science to reliably supply APIs to the Brazilian market.

Brazil's ANVISA operates its GMP regulations based on WHO standards. The inspection process proceeds in the following order: △ On-site inspection of the manufacturing facility △ Document review △ Notification of the inspection report and results △ Publication in the official gazette and issuance of the certificate. Following the listing of Chungju Plant as a GMP-certified company in Brazil's official gazette on the 14th, Kolon Life Science has recently received the official certificate, confirming once again that the plant possesses a global-level manufacturing and quality management system. The certification is valid until July 14, 2027. 

The certified product is the hyperlipidemia treatment API ‘Pitavastatin Calcium Hydrate’. Demand for Pitavastatin is steadily increasing globally driven by factors such as the growing elderly population and rising cardiovascular disease patients due to changing dietary habits. According to global market research firm Mordor Intelligence, the global Pitavastatin market is projected to reach approximately $917.97 million by 2030, with a CAGR of 6.01% from 2025 to 2030.

Kolon Life Science has successfully entered the generic drug markets in Korea, Japan, Taiwan, and Europe with Pitavastatin, achieving stable sales and profits while solidifying its growth foundation. Recently, it introduced a new manufacturing process and completed the ‘Process Validation’ procedure, improving both production efficiency and quality. 

Brazil is the largest pharmaceutical market in Latin America and ranks as the world's seventh-largest market. It is considered a strategic gateway that global pharmaceutical companies must pass through to enter Latin America. ANVISA's GMP certification is based on high-level quality and safety standards and serves as a crucial credibility indicator for both local and global pharmaceutical companies. With this certification, Kolon Life Science has gained the opportunity to expand its influence into global markets including Latin America. Kolon Life Science is further pursuing the expansion of its Pitavastatin supply chain into major global markets such as the United States, China, and Southeast Asia. This ANVISA GMP certification in Brazil is expected to serve as a crucial stepping stone in this global market entry strategy. 

Kim Sun-jin, CEO of Kolon Life Science, stated, “This Brazilian GMP certification signifies that the quality and production system of Kolon Life Science's APIs have once again received international recognition.” He added, “We will continue to reliably supply various APIs, including Pitavastatin, to countries worldwide and strengthen cooperation with our global partners”. 

Meanwhile, Kolon Life Science is continuously investing in improving its production facilities and manufacturing processes to enhance its quality competitiveness. Based on this, the company plans to continue providing a stable and reliable supply chain to its global customers.