CARBOGEN AMCIS, the Swiss-based pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing specialist, has achieved a significant regulatory milestone with its Shanghai facility receiving its first Drug Manufacturing License (DML) from China's National Medical Products Administration (NMPA).
The license was granted following a comprehensive inspection by the NMPA that focused on GMP compliance and operational readiness. The Shanghai site successfully met all regulatory expectations, confirming full compliance with Chinese GMP standards and regulatory frameworks.
Strategic Expansion in Asian Markets
This approval represents a pivotal step in CARBOGEN AMCIS' strategic expansion across Asia and reinforces the company's commitment to serving pharmaceutical partners throughout the region. The milestone strengthens the company's position in the Chinese pharmaceutical market and demonstrates its long-term commitment to building a trusted presence in the region.
"Achieving NMPA approval reinforces our long-term commitment to building a trusted and sustainable presence in the Chinese pharmaceutical market," said CEO Stephan Fritschi. "It's a testament to the strength of our team and the strategic role that our Shanghai operations play in our global network."
Comprehensive Manufacturing Capabilities
Located within the Shanghai Chemical Industry Park (SCIP), the 40,000 m² facility serves as a fully self-supporting operation equipped for the complete pharmaceutical development spectrum. The site offers services ranging from early-phase research and development to pilot scale production and commercial GMP manufacture.
The facility features four segregated production units with reactor capacities ranging from 50 to 6,300 litres, designed for flexibility, efficiency and scalability. The site's capabilities extend to handling highly potent materials and performing micronisation, with equipment to manage highly potent compounds up to category 3.
"In addition to our core manufacturing capabilities, we're proud that the Shanghai site is equipped to handle highly potent compounds up to category 3 and provide full GMP product release and analytical support," said Harry Wong, Country Manager at CARBOGEN AMCIS Shanghai.
Quality Systems and Operational Excellence
The facility employs over 140 staff, bringing together an international team of specialists whose expertise, combined with advanced infrastructure, enables the delivery of tailored, scalable solutions to customers worldwide. The site's services span from raw materials to APIs, supported by comprehensive analytical and GMP release services.
"This achievement underscores our team's commitment, disciplined execution, and the robustness of our Quality Management System, which has been rigorously aligned with both corporate and Chinese regulatory requirements," said Simone Maggi, Quality Head at CARBOGEN AMCIS Shanghai.
The license approval confirms the high standard of the facility's quality systems and demonstrates the site's ability to execute seamless technology transfers while maintaining alignment with the highest quality standards across CARBOGEN AMCIS' global network. This capability positions the facility to support complex projects and technology transfers within China and globally.
