Hubei YuanDa FuChi Pharmaceutical & Chemical Co., Ltd. (Stock Abbreviation: YuanDa FuChi; Stock Code: 838127), located in the Huangshi Economic and Technological Development Zone, Hubei Province, is a national high-tech enterprise specializing in the research, development, production, and sales of high-end pharmaceutical intermediates, specialty active pharmaceutical ingredients (APIs), and fine chemical products. The company was listed on the National Equities Exchange and Quotations (NEEQ) for Small and Medium Enterprises in 2016. It operates three cGMP-compliant manufacturing workshops and possesses stable mass-production capability—on a ton-scale—using green processes.  

The company’s core business involves key intermediates and API precursors for anti-tumor, antiviral, cardiovascular, and central nervous system drugs, serving global CDMO clients in both generic and innovative pharmaceuticals. Notable partners include Sun Pharmaceutical Industries Ltd. (India), STADA Arzneimittel AG (Germany), and Sumitomo Chemical Co., Ltd. (Japan). Its core competencies encompass asymmetric synthesis, chiral resolution, continuous-flow microreaction, and stabilization technologies for highly reactive intermediates. The company holds 12 authorized invention patents (including 10 Chinese invention patents and 2 PCT international patents) and 5 utility model patents. Its “Green Synthesis Technology for the Key Intermediate of Ticagrelor” received the Third Prize of Hubei Provincial Science and Technology Progress Award and has obtained EU Certificate of a Suitability of an Active Substance (CEP) certification (CEP 2022-387). One workshop at its Huangshi base passed the U.S. FDA on-site inspection (October 2021; Report No. 483-2021-1187); another workshop has completed the pre-audit by the European Directorate for the Quality of Medicines & HealthCare (EDQM) and entered the CEP master file update procedure.  

The company holds a “Pharmaceutical Production License” (Category Code: Hb), a Work Safety Production License, and certifications for ISO 9001:2015, ISO 14001:2015, and GB/T 45001:2020. It has been recognized as a Hubei Provincial “Specialized, Refined, Distinctive, and Innovative” (Zhuan Jing Te Xin) “Little Giant” Enterprise (re-evaluated and approved in 2023). In 2023, exports to the European Union accounted for 41.7% of total exports; exports to countries along the Belt and Road Initiative increased by 28.3% year-on-year (primarily to Russia, Kazakhstan, and Turkey). In 2024, the “New Green Synthesis Process for Apixaban,” jointly developed with Shanghai Pharmaceuticals Holding Co., Ltd., successfully completed pilot-scale validation and has entered the supplier qualification assessment phase with two domestic formulation manufacturers.  

The company does not operate any overseas subsidiaries. However, it collaborates technically and coordinates production capacity with international CDMO enterprises—including Lonza (Switzerland) and Catalent (Belgium)—to support cross-border project delivery and localization of process packages. Publicly available information does not indicate independent engineering design qualifications or EPC (Engineering, Procurement, and Construction) general contracting capabilities. Its technical services primarily focus on customized intermediate process development, cGMP-compliant manufacturing, and transfer of green processes.