Xihua Pharma 上海熙华药业有限公司
Pharmaceuticals - Bellevue, Washington, United States
Xihua Pharma 上海熙华药业有限公司 Employees
Xihua Pharma 上海熙华药业有限公司 Senior Management
Xihua Pharma 上海熙华药业有限公司 Details
Xihua Pharma's R&D teams provide services including API process R&D and scale-up, analysis for small & large molecules as well as gene and cell therapy products (GCTP), formulation development for NCE，clinical trial material manufacturing and regulatory affairs services as well as integrated CMC development and filing programs. Additionally formulation team also focuses on generic products development including formulation process R&D, scale-up, technology transfer, analytical support and regulatory affairs services. The CDMO platform Fujian Xihua Pharma is engaged in process R&D and commercial manufacturing of advanced intermediates and API. Together Xihua Pharma provides one-stop services from R&D to commercial manufacturing of API and formulation (DP), analysis of large/small molecules and GCTP, and regulatory filing, which are integrated solutions for innovative and generic drugs. Primera Analytical Solutions, Xihua's subsidiary provides analytical services for small/large molecules, cell & gene therapy products. Primera occupies over 4000 m² laboratory space. There are more than 100 employee and more than 200 customers now, which broadens Xihua's capability in bioanalysis, pharmaceutical analysis, and clinical data statistical analysis in the United States. 熙华药业药物研发部门专门从事原料药工艺研发，大小分子和基因细胞治疗产品的分析研发，创新药制剂研发和临床用制剂生产，药政申报以及CMC一体化研发和申报。制剂部门还从事仿制药制剂工艺研发，放大和技术转移，分析支持和药政申报服务。熙华药业的研发生产CDMO平台熙翔制药正在建设高级中间体与原料药的研发和商业化生产厂房。熙华药业整合了从化学原料药（API）到制剂（DP）研发，放大，生产和药政服务，为创新药和仿制药的研发到后续的商业化生产提供了一体化解决方案。熙华控股子公司美国普林迈瑞提供大、小分子和基因细胞治疗产品的分析服务、生物分析和数据统计业务，目前拥有4000余m²场地及100余名员工，200余家客户，拓展了熙华在美国开展生物分析、分析服务及临床试验数据统计工作的能力。
