Wedoany.com Report-May 1, Carbogen Amcis, a Switzerland-based company specializing in pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing, has announced that its Shanghai facility has received its first Drug Manufacturing License (DML) from China’s National Medical Products Administration (NMPA). 

Carbogen Amcis has announced that its Shanghai facility has successfully obtained its first Drug Manufacturing License from China’s National Medical Products Administration.

The NMPA granted the approval after a thorough evaluation of the facility’s compliance with Good Manufacturing Practices (GMP) and operational preparedness. The Shanghai site met all regulatory standards, highlighting its advanced capabilities and robust quality systems. This milestone strengthens Carbogen Amcis’ presence in China and underscores its dedication to serving customers in the region.

Located in the Shanghai Chemical Industry Park (SCIP), the 40,000-square-meter facility operates independently, supporting early-phase research, pilot-scale production, and commercial GMP manufacturing. It handles a range of services, from raw materials to APIs, including high-potency compounds and micronization. Equipped with four segregated units and reactor capacities from 50 to 6,300 liters, the site is designed for flexibility and scalability. Employing over 140 staff, the facility integrates an international team of experts, delivering tailored solutions to global clients.

Simone Maggi, Quality Head at Carbogen Amcis Shanghai, stated: “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.”

Harry Wong, Country Manager for Carbogen Amcis Shanghai, added: “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. 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 of Carbogen Amcis, remarked: “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.”

The DML enhances the Shanghai facility’s ability to support the pharmaceutical industry by providing high-quality API manufacturing and development services. This achievement positions Carbogen Amcis as a reliable partner for pharmaceutical companies, contributing to the growth of advanced manufacturing capabilities in China.