Boryung Yesan Campus Secures EU-GMP Certification
Yesan Campus, a key production base for Boryung, has secured an additional high-level quality certification aimed at entering the European market.Boryung said on Nov. 10 that the solid formulation production facility at its Yesan Campus had obtained EU Good Manufacturing Practice, or EU-GMP, certifi
Boryung Yesan Campus, a crucial production hub for Boryung, has achieved another significant quality certification to bolster its presence in the European market. On November 10th, the company announced that its solid formulation production facility at the Yesan Campus had obtained EU Good Manufacturing Practice (EU-GMP) certification, the European Union’s benchmark for manufacturing excellence and quality control in medical products.
This certification was a result of a thorough on-site inspection carried out from August 17th to 20th by a supervisory authority from the Tübingen region of Germany, a highly-regarded pharmaceutical market in Europe. The inspection team meticulously examined all facets of pharmaceutical manufacturing and quality control, encompassing the manufacturing facilities, quality management system (QMS), quality risk management (QRM), data integrity, and storage and supply chain management.
Given the stringent nature of German regulatory evaluations even within Europe, Boryung's successful fulfillment of these rigorous standards is deemed a noteworthy accomplishment. Situated in Yesan, South Chungcheong Province, Yesan Campus, a smart factory inaugurated in 2019, boasts the capability to manufacture around 870 million tablets of solid formulations on an annual basis.
Presently, the facility is in full swing producing the Kanarb product line, a novel hypertension medication, as well as Zyprexa, an original schizophrenia treatment, alongside additional products. Harnessing advanced automation systems, the site maintains both operational efficiency and high-quality standards. With this latest certification marking a pivotal moment, Boryung intends to aggressively extend its global business reach.
In addition to boosting overseas supply volumes of essential solid-formulation medications such as Zyprexa and Kanarb, the company also aims to pursue contract development and manufacturing organization (CDMO) opportunities through collaborations with international pharmaceutical entities. This strategic move aligns with Boryung's overarching objective to focus its entire capabilities on global business expansion, including its recent acquisition of global business rights to Taxotere, an original cytotoxic anticancer drug.
Park Kyung-sook, the head of Boryung's Production Quality Division, commented, "Following anticancer injections, we have now secured EU-GMP compliance for solid formulations as well, reinforcing that the manufacturing prowess of Yesan Campus meets global regulatory standards," and further stated, "We will persistently enhance our quality capabilities so that this site can function as a strategic cornerstone for our global business expansion."
Written by urgent.news from BusinessKorea's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
