HK Innoen's K-CAB Receives Brazilian GMP Certification, Advances Global Market Expansion
Key Insights
HK Innoen (search)'s Daeso Plant obtained Brazilian GMP certification from ANVISA for tegoprazan API manufacturing, enabling potential K-CAB supply to Brazil's pharmaceutical market.
K-CAB has been selected as a "Current World-Class Product" by Korea's Ministry of Trade, Industry and Energy, making it the only pharmaceutical among 97 products chosen this year.
The P-CAB medication has expanded to 53 countries with launches in 18 markets, recording 196.9 billion won in Korean outpatient prescription sales in 2024.
HK Innoen (search) announced that its Daeso Plant has obtained Good Manufacturing Practice (GMP) certification from Brazil's Health Regulatory Agency (ANVISA) for tegoprazan API manufacturing, positioning the company to supply its gastroesophageal reflux disease (search) treatment K-CAB to Brazil's pharmaceutical market. The certification, announced on December 8, applies specifically to tegoprazan, the active pharmaceutical ingredient in K-CAB.
The Brazilian GMP certification represents a significant milestone for HK Innoen (search)'s global expansion strategy. In December 2022, the company signed a technology transfer agreement with Brazil's major pharmaceutical company Eurofarma (search), under which HK Innoen transfers K-CAB manufacturing technology while Eurofarma handles local production and sales of the finished product in Brazil, Latin America's largest pharmaceutical market.
Manufacturing Excellence and Global Standards
Located in Eumseong-gun, Chungbuk, the Daeso Plant serves as HK Innoen (search)'s production base for active pharmaceutical ingredients. The facility previously demonstrated its global quality capabilities by obtaining API GMP certification from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) in 2010. In 2019, the plant expanded its production facilities specifically for tegoprazan, establishing a comprehensive API supply system.
An HK Innoen (search) representative stated, "The Brazilian GMP certification is further proof that the Daeso Plant meets global quality standards as a manufacturing facility. This certification not only establishes a stable supply base for K-CAB's API in Brazil but also lays the groundwork for regulatory approval in Brazil, the largest pharmaceutical market in Latin America."
World-Class Product Recognition
Adding to its global recognition, K-CAB has been selected as a "Current World-Class Product" in the World-Class Product Promotion Project hosted by Korea's Ministry of Trade, Industry and Energy and KOTRA (search). Among the 97 products chosen as "Current World-Class Products" this year, K-CAB stands as the only pharmaceutical product to receive this designation.
The World-Class Product certification program, operated since 2001, designates products with global market shares of 5% or more, top-five worldwide rankings, and annual export volumes exceeding $5 million USD. Selected companies receive benefits including overseas marketing support, financial assistance, and export consulting to strengthen global market competitiveness.
Clinical Advantages and Market Performance
K-CAB represents Korea's 30th new drug and belongs to the P-CAB (potassium-competitive acid blocker) class for treating gastroesophageal reflux disease (search). Unlike conventional PPI (proton pump inhibitor) drugs, K-CAB competitively blocks potassium ions (search) at the final stage of gastric acid secretion, enabling rapid and powerful acid suppression.
The medication demonstrates clinical advantages including effects within one hour of administration for fast symptom relief and strong acid suppression maintenance even at night, significantly improving patients' quality of life. Additionally, K-CAB can be taken regardless of meal times, enhancing medication convenience and patient compliance.
Global Market Expansion
Currently, K-CAB has signed technology transfer or finished product export contracts with 53 countries and has launched in 18 countries, including Korea, China, and nations in Central and South America. In Korea's domestic market, K-CAB recorded outpatient prescription sales of 196.9 billion won in 2024, maintaining its position as the top peptic ulcer (search) medication for five consecutive years.
A representative from HK Innoen (search) stated, "K-CAB being selected as a World-Class Product is recognition of its potential in the global market. We will continue to contribute to elevating the status of Korea's pharmaceutical industry through the development of innovative new drugs and the expansion of our global market reach."