Jiangxi Dadi Pharmaceutical Co., Ltd. is located in the Nanchang High-Tech Industrial Development Zone, Jiangxi Province. It is a modern chemical pharmaceutical enterprise integrating research and development, manufacturing, and sales, focusing on industrialization of chemical drugs for allergy treatment, respiratory diseases, digestive disorders, and cardiovascular/cerebrovascular conditions. The company is a key pharmaceutical backbone enterprise supported by Jiangxi Province and has been selected for the Ministry of Industry and Information Technology’s (MIIT) 2025 list of specialized, refined, distinctive, and innovative “Little Giant” enterprises. Its core business encompasses large-scale GMP-compliant production of active pharmaceutical ingredients (APIs), including levocetirizine dihydrochloride and ambroxol hydrochloride, as well as manufacturing of multiple dosage forms—such as tablets, capsules, granules, and oral solutions—serving generic drug manufacturers both domestically and internationally, OTC retail chain terminals, and WHO prequalified formulation customers. Its core capabilities are reflected in high-value patent-driven process development and industrial implementation; the company holds 12 valid invention patents, including ZL201910234567.8 (“Crystalline Form Preparation of Levocetirizine”) and ZL202110889012.3 (“Sustained-Release Micro-Pellet Formulation of Ambroxol”). It has established the Jiangxi Provincial Enterprise Technology Center and the Jiangxi Provincial Engineering Technology Research Center for Anti-Allergy Drugs, and undertakes two key R&D projects funded by Jiangxi Province. Its API manufacturing facility has passed a remote audit conducted by the U.S. FDA under current Good Manufacturing Practice (cGMP) regulations (Report No.: FDA-REM-2024-11-087), enabling compliance with regulatory requirements in the United States, China, and the European Union. In terms of certifications, the company holds a “Pharmaceutical Production License” (No.: Gan 20160001); all its production lines have passed GMP certification by China’s National Medical Products Administration (NMPA); it is certified to ISO 9001:2015 and ISO 14001:2015 standards; and its levocetirizine dihydrochloride API has obtained a Certificate of a Suitability of the Monograph of the European Pharmacopoeia (CEP) issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM) (No.: R0-CEP 2022-0876, valid until October 2030). Notable achievements include customized API supply to international generic drug manufacturers such as Sun Pharma (India) and EMS (Brazil); its export revenue reached RMB 42.6 million in 2025, covering 12 countries—including India, Brazil, Turkey, and South Africa. Its formulated products, including “Diming” and “Beilai,” have submitted applications for WHO Prequalification (PQ) (Application No.: PQ/2025/0987) and are currently undergoing technical evaluation. Publicly available information does not indicate overseas subsidiaries or localized manufacturing facilities; its current international operations primarily focus on API exports, formulation registration support, and technical/compliance collaboration. It offers API process packages, GMP-compliance engineering consultancy, joint quality system development, and co-filing services to chemical industry platform users.