Shanghai Xihua Scientific Co. Ltd. was founded in the China Pilot (Shanghai) Free Trade Zone in February 2015. Xihua has become an international biomedical technology entity company, which matches the quality standards not only in China, but also in the United States.


熙华简介


Xihua Scientific has two locations in the Shanghai Zhang Jiang Pharm Valley. Currently, there are over 5,600 sq.m of laboratory and office space, more than 240 employees, 31 sets of LC-MS, and more than 120 pieces of other equipment. In Princeton, New Jersey, Xihua has an affiliate Primera, a CMC and bio-analytical services laboratory, which has been inspected by the US FDA many times. Primera has about 100 researchers. 



Xihua provides one-stop service for global pharmaceutical industry with high-quality and efficiency in late phase drug research and development, including innovative and generic drug CMC, API process development, formulation development, analytical testing, bio-analytical, clinical trial services and statistics. Xihua also has services in study and quality related consultation and training.


Xihua has established wide partnerships with more than 100 clients, which consist of pharmaceuticals companies, hospital clinical units, clinical CROs, universities and research institutes, and others.


Xihua has passed the laboratory quality assessment by the Department of Health in China for the past three years in a row, and has also completed more than 200 BE and innovative drug clinical studies. Among them, 40 projects of these projects have passed NMPA on-site inspection.  


For the last two years, Xihua was appointed by the NMPA to organize Training Courses on Technique and Quality Management for Clinical PK Samples Analysis. More than 200 people from domestic pharmaceutical companies completed the training.


Xihua is willing to share the experiences implementing Chinese and Western professional industry standards to provide high-quality services, make a contribution to improving drug quality, and promote human health.


Shanghai Xihua Pharma is a wholly-owned subsidiary of Shanghai Xihua Scientific. Xihua Pharma operates under strict adherence to cGMP guidelines to provide full CMC services for innovative and generic pharmaceutical drug development. Data from Xihua Pharma complies with registration requirements set forth by China,US and other health authorities. Current services includes API development and manufacturing, formulation development and clinical trial supply manufacturing, analytical development and stability study, dossier preparation and global regulatory submission. It occupies over 3,600 square meters of laboratory space with advanced facilities, equipped with state-of-the art oral and injections product development equipment, and analytical instruments from global well-known manufactures.



Core members of Xihua Pharma are from the expert team of world-renowned innovative and generic drug companies in China and the United States. They have completed many development projects and received numerous regulatory approvals by global health authorities such as FDA/NMPA/EMA. Xihua Pharma team has extensive experiences in API and formulation development, scale up production, technology transfer, analytical method development and validation.


The Process R&D laboratories, located in Zhangjiang High-Tech Park, occupies over 600 square meters lab space with a full array of process equipment and dedicated manufacturing suites for advanced intermediates and final APIs. The clinical trial supply manufacturing facilities, located in Lishizhen Road of Zhangjiang High-Tech Park is in the stage of equipment and faclitity qualification and commissioning and will be ready under cGMP by the fourth quarter of 2020.