Boryung announced that its solid dosage form production facility at the Yesan Campus in South Chungcheong Province has passed an on-site inspection by German regulatory authorities and obtained EU-GMP certification. The company plans to expand the overseas supply of key solid dosage forms, including the hypertension treatment 'Canab' and the schizophrenia medication 'Zyprexa,' and seek additional CDMO business opportunities in collaboration with global pharmaceutical companies.
EU-GMP is a standard that evaluates the manufacturing and quality management compliance of pharmaceuticals supplied to the European Union market. The GMP supervisory authority from the Tübingen region in Germany inspected the Yesan Campus from August 17 to 20, reviewing the manufacturing facility, quality management system (QMS), quality risk management (QRM), data integrity, storage, and supply chain management.
In 2023, Boryung also received EU-GMP certification for its cancer injection production facility at the Yesan Campus after undergoing an inspection by German regulatory authorities. With the recent certification of the solid dosage form production facility, the Yesan Campus has expanded its role as a global production base encompassing both injectable and oral pharmaceuticals.
Boryung is accelerating its overseas business expansion, recently acquiring the global rights to the original cytotoxic anticancer drug 'Taxotere' (generic name docetaxel). A company representative stated, "By meeting European manufacturing and quality management standards for both injectable and solid dosage form production facilities, we have enhanced our competitiveness in the global pharmaceutical production market."
The Yesan Campus, completed in 2019 in Yesan, South Chungcheong Province, is equipped to produce approximately 870 million solid dosage forms annually. It began production of the anti-ulcer drug 'Stogajung' (generic name lafutidine) in early 2020 and currently manufactures the Canab product line and Zyprexa.
Park Kyung-sook, head of Boryung's production quality division, remarked, "Securing EU-GMP compliance for both injectable and solid dosage form production facilities signifies that the manufacturing and quality competitiveness of the Yesan Campus has reached a level that meets global regulatory standards. We will continue to enhance our manufacturing and quality capabilities to ensure the Yesan Campus serves as a strategic base for global business expansion."
Meanwhile, Boryung's consolidated revenue for the third quarter of this year reached 314.4 billion won, reflecting growth compared to the same period last year. The cumulative operating profit stood at 69.4 billion won, surpassing the previous year's annual operating profit within just three quarters.
* This article has been translated by AI.
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