Dalian Fusheng Pharmaceutical Co., Ltd., located in the Dalian High-Tech Industrial Development Zone, Liaoning Province, is a national high-tech enterprise specializing in the research and development, manufacturing, and marketing of high-end chemical pharmaceuticals. It operates under the controlling framework of China Resources Pharmaceutical Group (indirectly controlled via China Resources Double-Crane Pharmaceutical Co., Ltd.) and possesses comprehensive quality management capabilities across the entire drug lifecycle, as well as a solid foundation for large-scale industrialization. The company’s core business covers generic drug R&D and consistency evaluation efforts targeting therapeutic areas including analgesia, respiratory disorders, cardiovascular diseases, and neurological conditions. Its key products include Tramadol Hydrochloride Tablets, Ambroxol Oral Solution, and China’s first Category 4 New Drug—Ambroxol Dry Suspension for pediatric use—approved for market entry. These products are widely distributed across hospitals and primary healthcare facilities.  

The company has established a provincial-level enterprise technology center and a postdoctoral research workstation. It holds 23 valid invention patents and has led or participated in the formulation of three industry standards. Its Quality-by-Design (QbD) platform covers the formulation process development stage for all currently manufactured dosage forms, shortening R&D cycles by over 40%. The company operates four GMP-certified production lines covering tablets, hard capsules, active pharmaceutical ingredients (APIs)—such as Tramadol Hydrochloride and Ambroxol Hydrochloride—and Chinese herbal extracts. Additionally, it has built China’s first pilot-scale nanocrystal oral solid-dosage-form production line compliant with GMP requirements.  

The company has obtained certifications for three major management systems: ISO 9001:2015, ISO 14001:2015, and ISO 45001:2018. Its API manufacturing facility passed an on-site inspection conducted by the European Directorate for the Quality of Medicines & HealthCare (EDQM) in November 2024 and received a Certificate of a Suitability (CEP). In February 2025, it obtained formal confirmation from the U.S. Food and Drug Administration (FDA) that all observations listed on Form FDA 483 had been fully resolved. Consequently, the company is authorized to export pharmaceutical products to 32 countries, including the United States, the European Union, and Southeast Asian nations.  

Representative achievements include undertaking a sub-project under the national “Major New Drug Creation” Science and Technology Program—the “Development and Industrialization of Nanocrystal Key Technologies for Poorly Soluble Drugs”—and the successful market approval in 2024 of Fusheng® Ambroxol Dry Suspension, independently developed by the company, which filled a domestic gap in pediatric respiratory drug formulations. In 2025, API export revenue reached USD 42.8 million, representing a 19.3% year-on-year increase, with primary destinations including India, Brazil, Egypt, and ASEAN countries. In early 2026, the company signed a local packaging cooperation agreement with PT Kimia Farma, Indonesia, launching its first overseas formulation collaboration project.