Shanghai site secures first drug manufacturing license

CARBOGEN AMCIS, the Swiss-based specialist in pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing, has announced that its Shanghai facility has been awarded its first Drug Manufacturing License (DML) by the National Medical Products Administration (NMPA) of China.

The license, granted following a comprehensive inspection by the NMPA, confirms the Shanghai site's full compliance with Chinese GMP standards and regulatory expectations. This approval marks a major milestone in CARBOGEN AMCIS’ strategic expansion across Asia and strengthens its ability to serve pharmaceutical partners throughout the region.

Situated within the Shanghai Chemical Industry Park (SCIP), the 40,000 m² facility offers a full range of services from early-phase R&D to commercial GMP production. It includes four segregated production units with reactor capacities from 50 to 6,300 litres, as well as capabilities for handling highly potent materials and performing micronisation. Employing over 140 staff, the site delivers scalable, high-quality solutions supported by robust quality management systems.

“This is a key moment in our growth journey in China,” said Simone Maggi, Quality Head at CARBOGEN AMCIS Shanghai. “The license confirms the high standard of our quality systems and our alignment with both corporate and local regulatory frameworks.”

Harry Wong, Country Manager at the Shanghai site, added: “In addition to our manufacturing capabilities, we are fully equipped to handle high potency compounds up to category 3, supported by comprehensive analytical and GMP release services. This license is a strong endorsement of our readiness to support complex projects and technology transfers within China and globally.”

CEO Stephan Fritschi commented: “Achieving NMPA approval reinforces our long-term commitment to building a trusted and sustainable presence in the Chinese pharmaceutical market. It’s a testament to the strength of our team and the strategic role that our Shanghai operations play in our global network.”

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