Jinan Zhuocheng Bio-Tech Co., Ltd.

With the continued implementation of China’s centralized drug procurement policies and increasing demand for supply chain stability across the pharmaceutical industry, the integrated development of active pharmaceutical ingredients (APIs) and finished dosage forms has become a key strategy for pharmaceutical companies to enhance competitiveness. Jiangsu Deyuan Pharmaceutical Co., Ltd. (hereinafter referred to as “Deyuan Pharmaceutical”) has been continuously advancing its “API + finished dosage integration” strategy. The company’s integrated API and finished dosage production base project has achieved significant progress, providing strong support for stable supply, cost optimization and long-term development of its chronic disease treatment portfolio.

Located in the Lianyungang Economic and Technological Development Zone, Jiangsu Province, the first phase of Deyuan Pharmaceutical’s integrated production base represents a total investment of approximately RMB 1 billion. Covering an area of about 200 mu, with a total construction area of approximately 83,000 square meters, the project includes quality inspection facilities, API production workshops, finished dosage production workshops, utility facilities, control centers, hazardous material storage areas and other supporting infrastructure.

In March 2025, the first phase of the project completed full-process equipment commissioning and officially entered the trial production stage. By the end of 2025, the main construction works and several production lines had reached their intended operational status and were transferred into fixed assets, resulting in an increase of approximately RMB 291 million in fixed assets. The company is currently advancing relevant approval procedures and preparations for full commercial operation.

According to publicly disclosed information, the project is designed with an annual production capacity of 1,078 tonnes of APIs and 2.96 billion tablets of solid oral formulations. Key API production capacity includes 1,000 tonnes per year of metformin hydrochloride, 50 tonnes per year of nateglinide, 10 tonnes per year of pioglitazone hydrochloride, 13 tonnes per year of gliptin products and 5 tonnes per year of epalrestat.

The major API products covered by the project include metformin hydrochloride, nateglinide, pioglitazone hydrochloride, gliptin-class products (including alogliptin benzoate, sitagliptin phosphate, linagliptin and trelagliptin succinate) and epalrestat. These APIs will primarily support the company’s finished dosage products in chronic disease areas such as diabetes and hypertension, strengthening internal supply capabilities for key pharmaceutical ingredients.

The project also highlights the company’s focus on green manufacturing and digital transformation. Wastewater, steam and chemical materials within the production area will be transported through enclosed elevated pipelines, reducing environmental risks while facilitating real-time monitoring and maintenance. Meanwhile, the production facilities are equipped with a distributed control system (DCS), enabling real-time monitoring of equipment status, temperature, pressure and other key parameters. Intelligent warning and automatic safety interlock functions further improve production safety and operational efficiency.

To support large-scale production of metformin hydrochloride and other APIs, the project has introduced automated packaging systems equipped with robotic handling, automatic filling and packaging modules. The integrated system enables a closed-loop process from product filling to finished goods storage, improving production efficiency and consistency.

Industry analysts believe that Deyuan Pharmaceutical’s API–finished dosage integration strategy will significantly enhance supply chain resilience. Under the background of normalized centralized procurement, pharmaceutical companies with independent API production capabilities can better manage raw material price fluctuations, reduce external supply dependence and strengthen cost competitiveness.

At present, the company’s API production is mainly used for internal finished dosage manufacturing. In the future, if additional production capacity becomes available, Deyuan Pharmaceutical may consider expanding external API supply to further enhance its market presence.

In the chronic disease treatment sector, Deyuan Pharmaceutical has established a comprehensive product portfolio. In the diabetes treatment field, excluding insulin products, the company has achieved broad coverage of major therapeutic targets. A total of 18 products have entered national or provincial centralized procurement programs, while the company holds 41 finished dosage approvals. In addition, 19 APIs have been approved for use in marketed pharmaceutical products, with major products having passed or been deemed to have passed consistency evaluations.

With the continued advancement of its API production base, Deyuan Pharmaceutical is expected to further strengthen its integrated industrial chain from API manufacturing to finished dosage production, improving the stability and accessibility of chronic disease medications and providing patients with more reliable treatment options.