Boehringer Ingelheim Expands Contract Manufacturing in China with Regulatory Reform

• Boehringer Ingelheim BioXcellence™’s Shanghai facility qualifies for China’s segmented manufacturing regulatory reform, led by the NMPA.

• The company will expand its contract manufacturing services in China, supporting local and global biopharmaceutical supply chains.

Boehringer Ingelheim BioXcellence™ has secured approval to participate in China’s segmented manufacturing reform, a regulatory initiative led by the National Medical Products Administration (NMPA). This programme aims to enhance efficiency and flexibility in the production of biological products. With this qualification, Boehringer Ingelheim strengthens its position as one of the few contract manufacturing organisations (CDMOs) authorised to offer distinct service packages for different production segments in China.

Segmented manufacturing involves dividing the production process into separate stages, each managed independently. This approach allows different components of a medicine to be manufactured at various facilities, including those in different countries. The Shanghai facility, which has been operating for over seven years, is well-positioned to support this model due to its robust quality management system and strategic location within China’s biopharmaceutical ecosystem.

Since 2016, Boehringer Ingelheim BioXcellence™’s Shanghai site has been part of China’s Market Authorization Holder reform, collaborating closely with local authorities to meet stringent regulatory standards. Now, with its comprehensive manufacturing and packaging capabilities, the facility is prepared for segment-by-segment technology transfers and commercial launches under the new framework.

“We can build on our more than 40 years of experience with this segmented manufacturing business model, as it is well established in the U.S. and the EU. Now we’re eager to roll out this concept in China to better serve our customers’ needs, by enhancing a reliable and sustainable global supply of life-changing biopharmaceutical medicines to patients in need,” said Andrea Rothmaler, Head of Boehringer Ingelheim’s contract manufacturing arm, BioXcellence™.