Zhejiang Kisun Pharmaceutical Co., Ltd.
— Dual China-Europe Certification Guarantees Quality, Partnering with Global Leaders to Build a Healthy Future
As a wholly-owned subsidiary of A-share listed company Ausun Pharmaceutical Co., Ltd. (603229.SH), Zhejiang Kisun Pharmaceutical Co., Ltd. serves as the core execution platform for Ausun’s integrated strategy of “intermediates–specialty APIs–finished dosage forms.” Leveraging Ausun’s extensive experience in the R&D and commercialization of high-end specialty APIs and CDMO services, Kisun focuses on the development and manufacturing of high-end drug products. The company strictly complies with China’s GMP production regulations as well as cGMP regulations in Europe, the United States and Japan. Its related production lines have successfully passed both Chinese and European GMP conformity inspections, establishing a quality management system fully aligned with international standards.
Strategic Partnership with Global Generic Pharma Leader, Deeply Integrated into the International Pharmaceutical Supply Chain
In November 2021, Kisun entered into a Strategic Cooperation Agreement for Co-Development and Commercialization with STADA from Germany, a leading European generic drug company. This initiated a long-term, comprehensive Co-Development partnership to jointly develop several high-end drug products, including Imatinib Mesylate Tablets. Serving as the strategic production base for this collaboration, Kisun Pharma independently undertakes the development of API and the production of drug product for the partnered products. It supplies high-quality anti-tumor and anti-infective drug product to STADA, with both parties jointly responsible for marketing these product across 65 countries worldwide, truly realizing the vision of "Created in China, Shared Globally."
Empowered by International Drug Production Base, Setting a New Benchmark in High-End Manufacturing
Kisun has invested in the “International High-End Drug Products Project (Phase I),” which has completed a 12,654 m² high-potency drug production facility and a 16,809 m² oral solid dosage forms workshop. Equipped with state-of-the-art manufacturing and quality control systems, the site specializes in the production of highly potent targeted oncology tablets/capsules as well as conventional oral solid dosage forms. At present, more than ten high-end drug products are under development in parallel, covering multiple therapeutic areas such as oncology and anti-infectives. In 2024, the first collaborative product with STADA—Imatinib Mesylate Tablets—successfully obtained market approval in Europe, marking an important leap for Kisun from R&D to commercial production. In 2025, Imatinib Mesylate Tablets were also approved for marketing in China.
Upholding Rigorous Standards, Serving Global Health
Leveraging the extensive R&D foundation and comprehensive international cGMP system of its parent company, Kisun Pharma has established stable strategic partnerships with international pharmaceutical enterprises like STADA across all stages of drug product development, regulatory certification, and manufacturing. We are committed to providing safe, effective, and accessible innovative pharmaceutical solutions for patients worldwide, backed by our dual China-Europe certified quality assurance and internationally aligned R&D and production capabilities. Our goal is to become a benchmark for quality in the global expansion of Chinese pharmaceutical companies and to deliver outstanding value to the cause of human health.
Pharmacovigilance
Tel:+86-576-88113608
Email:pv@kisunpharm.net
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