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International Milestone | Dongbao Pharm's Insulin Aspart Manufacturing Site Receives an EU GMP Certificate
Date：2026-07-16
Author：东宝
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Recently, Tonghua Dongbao Pharmaceutical Co., Ltd. ("Dongbao Pharm" or the "Company") received a GMP certificate for its insulin aspart drug substances (DS), which was issued by the Swedish Medical Products Agency (MPA). This signifies that the Company's insulin aspart DS manufacturing site fully complies with EU GMP standards and establishes an important compliance foundation for the product's entry into the EU market, marking a major milestone in the Company's global expansion. The certification fully demonstrates that the Company's manufacturing quality management system meets stringent international standards and that its product quality control capabilities have been certified by official EU authorities, laying a solid foundation for the Company's continued expansion in global markets and the further advancement of its global strategy.
As one of the world's major pharmaceutical markets, the European Union maintains GMP standards that are recognized as among the strictest in the world for pharmaceutical manufacturing quality management. Its standards impose demanding requirements on end-to-end quality management, document integrity, deviation management, and supply chain transparency, and inspection results can be shared with the United States, Japan, and Canada. Driven by such rigorous standards and the international mutual recognition mechanism, the global influence of EU GMP certification and inspections continues to rise.
According to the International Diabetes Federation (IDF) Diabetes Atlas 11th edition, the number of people with diabetes in Europe continues to grow. In 2024, approximately 65.6 million adults aged 20–79 had diabetes, with a prevalence rate of 9.8%. Total diabetes-related healthcare expenditure reached USD 193 billion, with an average expenditure of USD 2,951 per person, ranking second globally. The total number of people with diabetes is projected to rise to 72.4 million by 2050, with a prevalence rate expected to reach 11%.
In the future, the Company will keep improving its global quality compliance system and drive the market entry of core pipeline products such as insulin and GLP-1 in more global markets. It will remain firmly committed to its global expansion strategy and deeply broaden its global business footprint, striving to provide diabetes patients worldwide with a broader range of high-quality and more accessible treatment options. At the same time, it will leverage the steady expansion and high-quality development of its overseas business to make the business an important driver of long-term growth.
