Boehringer Ingelheim’s biopharmaceutical facility in Shanghai, China, meets the conditions to participate in a regulatory reform promoting segmented manufacturing of biological products by the local authorities. The reform, led by the Chinese medicine authority NMPA (National Medical Products Administration), aims at enhancing control, efficiency, and flexibility in the production process.
As one of the few contract manufacturing organisations qualified for the pilot period, Boehringer Ingelheim BioXcellence is expanding its service portfolio in China, offering distinct service packages for different segments in biopharmaceutical production and enabling the sustainable global supply of medications to patients.
Boehringer Ingelheim BioXcellence in Shanghai is at the forefront of the reform due to its expertise and global supply capabilities. As a pilot site in the Chinese Market Authorisation Holder reform since 2016, the site has been working closely with the local government. It meets stringent regulatory standards and is characterized by a robust quality management system.
Strategically located in Shanghai’s biopharmaceutical ecosystem, the site has been producing innovative therapies for more than seven years. With its comprehensive manufacturing and packaging capabilities, the site is fully equipped to support a segmented manufacturing approach and is prepared for segment-by-segment tech transfer and commercial launch in China.
