Carbogen Amcis’ Shanghai facility has successfully obtained its first Drug Manufacturing License (DML) from China’s National Medical Products Administration (NMPA) following 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 micronization. With equipment in four segregated units and reactor capacities from 50 to 6,300 liters, 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.

Stephan Fritschi, CEO at Carbogen Amcis, stated: “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.”