Dongkook Life Science said April 20 it has obtained a Certificate of Suitability, or CEP, for its iopamidol active pharmaceutical ingredient.
A CEP is a quality certification for APIs issued by the European Directorate for the Quality of Medicines & HealthCare, or EDQM, and is a key requirement for entering the European pharmaceutical market.
Iopamidol is a nonionic iodine-based contrast agent used in CT scans. The company said demand for diagnostic imaging is rising, and that securing quality at the API stage is closely tied to the competitiveness of finished drugs.
Dongkook Life Science previously obtained approval from China’s National Medical Products Administration, or NMPA, for its gadobutrol API, an MRI contrast agent.
In Japan, a manufacturer of a finished drug using the company’s gadobutrol API has cleared the Pharmaceuticals and Medical Devices Agency, or PMDA, approval process, securing a supply base. The company said this links Europe, China and Japan into a global supply chain for contrast agents.
“We plan to increase the share of overseas sales by advancing quality and strengthening production capabilities,” a company official said.
* This article has been translated by AI.
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