Products from the Same Production Line Approved for Domestic Launch, Winning Recognition at Home and Abroad with High-Quality Standards

       On November 19, the first batch of imatinib tablets manufactured by Zhejiang Kisun Pharmaceutical Co., Ltd. for the German company STADA was successfully dispatched, officially beginning its export journey to Europe. The products will be gradually supplied to Germany, France, Italy, the United Kingdom, Switzerland, Belgium, Nordic countries, as well as Romania, Slovakia, and other countries and regions. This milestone marks another significant achievement in the company’s expansion into the international high-end generic pharmaceutical market.

       As a widely used and clinically important anticancer drug, imatinib tablets are subject to stringent requirements by European regulatory authorities and markets with respect to quality standards, manufacturing consistency, and supply stability. The exported products were manufactured strictly in accordance with the regulatory requirements of the destination markets and under a GMP-compliant system, fully aligned with relevant European quality management standards and technical specifications. From raw and excipient qualification, control of critical process parameters, to finished product release testing, comprehensive and traceable quality controls were implemented throughout the entire process to ensure that product safety, efficacy, and stability consistently meet the high standards of the European market.

       Notably, Zhejiang Kisun Pharmaceutical’s imatinib tablets have also been approved and marketed in China. The products exported to Europe are manufactured on the same production line as those sold domestically, sharing identical process foundations and stable manufacturing capabilities. At the same time, the company adheres to the management principle of “same production line, market-specific compliance.” On a unified manufacturing platform, production and batch release are conducted strictly in accordance with the GMP requirements, registration/marketing authorization conditions, and technical standards applicable to each target market. By integrating differentiated regulatory compliance management with consistent process control, the company has established a multi-market supply capability characterized by high manufacturing standards, a robust quality system, and reliable delivery performance.

       During its cooperation with STADA, Zhejiang Kisun Pharmaceutical has leveraged its technical expertise and large-scale manufacturing advantages in solid dosage forms. Through mature and stable production processes, strict change control, and ongoing process validation, the company continuously ensures high batch-to-batch consistency and a stable supply of products. The successful shipment of the first batch to multiple European countries and regions demonstrates the international partner’s strong confidence in the company’s quality system, compliance management capabilities, and supply reliability.

       In recent years, Zhejiang Kisun Pharmaceutical has been guided by internationally aligned quality standards, continuously strengthening its R&D, manufacturing, and quality management systems. The company has steadily improved the standardization, lean management, and automation of its production lines, establishing a closed-loop quality management system covering the entire product lifecycle. The successful supply of imatinib tablets to multiple European countries, alongside simultaneous commercialization in the domestic market, represents an important achievement in delivering high-standard manufacturing capabilities to patients worldwide.

       Looking ahead, Zhejiang Kisun Pharmaceutical will continue to uphold its development philosophy of “quality first, compliance as a priority,” further enhancing its multi-market regulatory compliance capabilities and manufacturing stability. The company will deepen cooperation with internationally renowned pharmaceutical partners to provide high-quality medicines with reliable supply to patients around the world, steadily advancing its internationalization strategy.