Securing a Foothold in Latin America...
Strengthening Global Quality Competitiveness
Kolon Life Science announced on July 24, 2025, that its Chungju Plant recently obtained Good Manufacturing Practice (GMP) certification for Active Pharmaceutical Ingredient (API) manufacturing and quality control from the Brazilian Health Regulatory Agency (ANVISA). With this certification, Kolon Life Science has secured the qualification to stably supply APIs to the Brazilian market.
Brazil's ANVISA operates its own GMP regulations based on World Health Organization (WHO) standards. The review process consists of on-site inspection of the manufacturing facility, document review, issuance of a review report and notification of results, followed by publication in the official gazette and issuance of the certificate. The validity period of the certification is until July 14, 2027.
The certified item is the API for hyperlipidemia treatment, "pitavastatin calcium hydrate." Demand for pitavastatin has been steadily increasing worldwide due to several factors, including the intensification of population aging and the rise in cardiovascular disease patients resulting from changes in dietary habits. According to global market research firm Mordor Intelligence, the global market size for pitavastatin is projected to reach approximately $917.97 million 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 not only in Korea but also in Japan, Taiwan, and Europe with pitavastatin, securing stable sales and profits and establishing a foundation for growth. Recently, the company introduced a new manufacturing process and completed the "process validation" procedure, thereby improving both production efficiency and quality.
Brazil is the largest pharmaceutical market in Latin America and ranks as the seventh largest in the world. 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 standards of quality and safety, serving as an important trust indicator for both local and global pharmaceutical companies.
With this certification, Kolon Life Science has gained the opportunity to expand its influence into the global market, including the Latin American region. The company is also working to expand its pitavastatin supply chain to other major global markets such as the United States, China, and Southeast Asia. The recent Brazilian ANVISA GMP certification is expected to serve as a significant stepping stone for these global market entry strategies.
Kim Sunjin, CEO of Kolon Life Science, stated, "This Brazilian GMP certification means that the quality and production system of Kolon Life Science's APIs have once again been internationally recognized," adding, "We will continue to stably supply various APIs, including pitavastatin, to countries around the world and strengthen cooperation with our global partners."
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