HK Innoen Daeso Plant Obtains Brazilian GMP Certification... Preparing for K-CAB Approval in Brazil

HK Innoen announced on December 8 that its Daeso Plant recently obtained Good Manufacturing Practice (GMP) certification for active pharmaceutical ingredient (API) manufacturing and quality management standards from the Brazilian Health Regulatory Agency (ANVISA). The certification applies to “Tegoprazan,” the main ingredient of the new drug for gastroesophageal reflux disease, “K-CAB.”

With this certification, HK Innoen has demonstrated the global manufacturing capabilities and quality competitiveness of its Daeso Plant. If K-CAB receives approval in Brazil, the largest pharmaceutical market in Latin America, the company plans to begin full-scale supply of the API, Tegoprazan.

Aerial view of HK Innoen Daeso Plant, Eumseong-gun, Chungbuk. HK Innoen

In December 2022, HK Innoen signed a technology transfer agreement for K-CAB with Brazil’s major pharmaceutical company, Eurofarma. Under this agreement, HK Innoen transfers the manufacturing technology for K-CAB, while its partner Eurofarma is responsible for local production and sales of the finished pharmaceutical product.

Located in Eumseong-gun, Chungbuk, the Daeso Plant serves as HK Innoen’s production base for active pharmaceutical ingredients. It met global quality standards by obtaining API GMP certification from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in 2010. In 2019, the plant expanded its production facilities for Tegoprazan, establishing a supply system for APIs. With the recent acquisition of Brazilian GMP certification, the plant has once again proven its compliance with the stringent quality standards of global regulatory agencies.

GMP refers to quality management standards throughout the pharmaceutical manufacturing process and is essential for ensuring consistency and integrity of quality. In particular, GMP certification from the Brazilian Health Regulatory Agency is recognized worldwide for its rigorous quality control standards and is considered a benchmark for trust among global pharmaceutical companies.

An HK Innoen 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.”

K-CAB, the 30th new drug developed in Korea, is a P-CAB (potassium-competitive acid blocker) class medication for gastroesophageal reflux disease. With its rapid onset of action and convenient dosing, it has expanded into 53 countries and has been launched in 18 countries, including Korea, China, and Latin American nations, strengthening its presence in the global market. In Korea, K-CAB recorded outpatient prescription sales of 196.9 billion won in 2024, maintaining its position as the top peptic ulcer medication in the domestic market for five consecutive years.

This content was produced with the assistance of AI translation services.