CARBOGEN AMCIS Shanghai facility has successfully obtained its first Drug Manufacturing License (DML) from China’s National Medical Products Administration (NMPA).
CARBOGEN AMCIS
The NMPA approval followed a rigorous review focused on GMP compliance and operational readiness. The Shanghai site successfully met all regulatory expectations, reflecting the maturing of its operations and the strength of its quality systems. This milestone marks a pivotal step in CARBOGEN AMCIS’ expansion in China and reinforces its commitment to customers in the region.
Located in the Shanghai Chemical Industry Park (SCIP), the 40,000m² site is a fully self-supporting facility equipped for early-phase research and development, pilot scale production and commercial GMP manufacture. Its services range from raw materials to APIs, including high potency material handling and micronisation. With equipment in four segregated units and reactor capacities from 50 to 6,300 litres, the facility is built for flexibility, efficiency and scalability. The site employs over 140 people and brings together an international team of specialists whose expertise, combined with advanced infrastructure, enables the delivery of tailored, scalable solutions to customers worldwide.
“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 - CARBOGEN AMCIS Shanghai site.
“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, CARBOGEN AMCIS Shanghai. “This license is a testament to the strength of our team and demonstrates our ability to execute seamless technology transfers and align with the highest quality standards across CARBOGEN AMCIS’ global network.”
Stephan Fritschi, CEO at CARBOGEN AMCIS, said: “Securing the Drug Manufacturing License not only demonstrates the operational readiness of our Shanghai site but also reflects the strength of our global quality culture. This achievement strengthens our long-term goal of becoming a trusted partner in the Chinese pharmaceutical market. I would like to take this opportunity to express my gratitude to every member of our site team for their dedication and to the Executive Team for their continuous support and trust throughout this journey."