DongKoo Bio & Pharma has gained additional time to address concerns following the suspension of its GMP license cancellation, pending a final ruling in an ongoing lawsuit.

On September 9, DongKoo Bio & Pharma announced that the court had accepted their injunction request on September 6, suspending the cancellation of their Good Manufacturing Practice (GMP) certification for solid oral dosage forms. The injunction was initially filed on August 13.

As a result of this decision, the company can maintain regular pharmaceutical manufacturing and production operations until the lawsuit concludes, ensuring a stable product supply. DongKoo Bio & Pharma emphasized that, despite the legal situation, it remains committed to expanding its production infrastructure as part of its long-term strategy. Recent measures include strengthening quality control and improving productivity, supported by external consulting services.

The company recently made a $14.9 million strategic investment to enhance its production facilities, increasing capacity by 1.5 times and improving overall quality. Since its KOSDAQ listing, DongKoo Bio & Pharma’s revenue has grown consistently, with 2023 standalone revenue reaching $160 million. In the first half of this year, the company achieved record revenue of $92.5 million.

With its expanded production facilities, the company plans to accelerate production of various products, including new diabetes treatments, in the second half of this year. Leveraging its enhanced capacity, DongKoo Bio & Pharma aims to meet market demand and further strengthen its position in the pharmaceutical industry. The company anticipates setting a new annual sales record this year.

CEO Yongjun Cho apologized to shareholders and customers for concerns caused by the recent GMP-related issues. He reaffirmed the company’s dedication to strict quality control and production improvements, vowing to restore trust. "We will continue to invest in production facilities to strengthen our manufacturing capabilities and meet the expectations of our customers and shareholders," he stated.