CARBOGEN AMCIS Gains NMPA Approval for Shanghai Manufacturing Site

• CARBOGEN AMCIS has received its first Drug Manufacturing Licence (DML) from China’s National Medical Products Administration (NMPA).

• The licence enables GMP-compliant commercial API manufacturing at its 40,000m² Shanghai facility.

CARBOGEN AMCIS, a Switzerland-based pharmaceutical process development and API manufacturing company, has secured its first Drug Manufacturing Licence (DML) from China’s National Medical Products Administration (NMPA). The licence marks a major milestone in the company’s expansion in China and authorises GMP-compliant production at its Shanghai facility.

The NMPA approval followed a detailed regulatory inspection that assessed GMP compliance and operational readiness. The Shanghai site successfully met all expectations, reflecting the strength of its quality systems and the maturity of its operations.

Located in the Shanghai Chemical Industry Park, the 40,000m² site supports a full range of services from early-phase development to commercial manufacturing, including high-potency material handling and micronisation. It houses over 140 employees and is equipped with four segregated production units and reactor capacities ranging from 50 to 6,300 litres, enabling flexible and scalable operations.

“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 the Shanghai site. Harry Wong, Country Manager, added, “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.”

CEO Stephan Fritschi commented: “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.”