Xihua Pharma

Shanghai Xihua Pharma is a wholly-owned subsidiary of Shanghai Xihua Scientific. Xihua Pharma CDMO platform consists of Shanghai XihuaPharma R&D, Shanghai Xihua PharmaTech, Fujian Xihua Pharma and Primera in the US. At present, we have more than 5,400 m² laboratory space, 120,000 m² factories under construction and more than 120 employees in China. Shanghai Xihua Pharma R&D teams provide services including API process R&D and scale-up, analytical for small & large molecules as well as gene and cell therapy products (GCTP), innovative formulation development, clinical supplies manufacturing and commercial formulation manufacturing, and regulatory affairs services. Shanghai XihuaPharmaTech is focused on generic products development including formulation process R&D, scale-up, technology transfer, analytical support and regulatory affairs services. Fujian Xihua Pharma is engaged in process R&D and commercial manufacturing of advanced intermediates and API. The plant under construction is 120,000 m², including early to commercial manufacturing of tumor drugs, non-tumor drugs and high activity APIs, and will go into service by the end of 2024. Together Xihua Pharma provides one-stop services from R&D to manufacturing of API and formulation (DP), analysis of large/small molecular and GCTP, and regulatory filing, which are integrated solutions for innovative and generic drugs. Primera Analytical Solutions provides analytical services for small/large molecules, cell & gene therapy products. Primera occupies over 4500m² of laboratory space. There are more than 120 employees and more than 200 customers now, which broadens Xinhua’scapability in bioanalysis, pharmaceutical analysis, and clinical data statistical analysis in the United States.