About Chengxin Pharma
Chengxin Pharmaceutical(as CX Pharma) are a high-tech professional API company that specialized in bio-enzyme technology and chemical synthesis technology. Our products are wildly used in pharmaceutical industry, supplement industry, and cosmetics industry. The company has more than 300 employees, and 45% of them are master, PHD and overseas returnees. The plant is designed and managed under GMP, CGMP and FDA standard. The company philosophy is green economy，advanced technology and humanity management. Our target is producing the highest quality API for our global customers.
Enzymatic technology innovation is the core competency of the company. Company owned the enzyme technology research center, operated by chief scientists who have been worked in global company like Pfizer & Cargill. More than 50 engineers in our R&D team. They are focusing on the development of enzyme modification, biological fermentation and chemical synthesis process.
We establish a long-term strategic partner agreement with the Chinese Academy of Sciences and other research institutions, to provide sustainable innovation. Research center is established with scientific management concepts, and advanced equipment are installed, such as high speed refrigerated centrifuge, PCR Amplifier, gel imaging analysis system, Electroporator, Automatic Potentiometric Titrator, ATS High Pressure Homogenizer, HPLC and GC, which provide professional support and services.
At present, R&D centers in Beijing, Shanghai.and manufacturing sites were established Manufactory site is located at Binjiang Pharm-Chem Industry Park, Qidong, Jiangsu. Site area is 60,000 m2, 3 workshops and 2 cleanrooms are built as GMP standard. Routine reactors are installed, and film evaporation system, ultrafiltration and nanofiltration systems also equipped. Process of microbial fermentation, build enzyme and catalyzed synthesis can expand to production scale (capacity: over 800 ton/year). Chemical synthesis is replaced by catalyzed synthesis which reduce use of organic solvent and improve quality of products, less side reaction and contamination.
CXPharma set up Quality management system based on the requirements of GMP, products are developed per QbD and quality risk management applies to every respect. Materials and products are analyzed by scientific methods to ensure the quality of products meet USP, EP and customized requirements from customers. Now, CXPharam certified by ISO 9001, written confirmation, HALAL，KOSHER and EDQM (CEP), qualifications from WHO and FDA are in progress.