CARBOGEN AMCIS Shanghai Site Gets Drug Manufacturing License from China’s NMPA

Switzerland-based pharmaceutical process development and API manufacturing company CARBOGEN AMCIS announced on April 22, 2025 that its facility in the Shanghai Chemical Industry Park, which is used for early-stage R&D, pilot scale production, and commercial good manufacturing practice (GMP) manufacture, has obtained its first drug manufacturing license (DML) from China’s National Medical Products Administration (NMPA) (1).

“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 a company press release (1).

The Shanghai facility, which CARBOGEN AMCIS said is fully self-supporting, offers services ranging from raw materials to APIs, including high potency material handling and micronization (1). Equipment is located in four segregated units; reactor capacities range from 50 to 6300 liters. The site employs more than 140 workers.

“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, in the press release (1). “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.”

The DML from NMPA comes one month after CARBOGEN AMCIS was granted a GMP certificate, the company announced on March 24, 2025, for its state-of-the-art sterile drug product manufacturing site in Saint-Beauzire, France, by the French regulatory authority Agence nationale de sécurité du médicament et des produits de santé (ANSM). The certificate was achieved following a routine inspection process conducted by ANSM to gauge GMP compliance. It permits the facility to manufacture and release clinical and commercial sterile drug products; ANSM had granted the site authorization to manufacture, test, and release drug products upon its February 2023 opening, with the first clinical batch released in January 2024 (2).

“The successful ANSM inspection reaffirms CARBOGEN AMCIS as a reliable partner in the drug product manufacturing market,” Helen Caddy-Leach, head of Business Development, Drug Product, said in a press release at the time (2). “With our extensive expertise and a state-of-the-art GMP-certified facility, we are well-positioned to support customers’ drug product projects with excellence.”

In similar fashion to that inspection, CARBOGEN AMCIS said the most recent review by NMPA, which focused on GMP compliance and operational readiness, found that the Shanghai site met all regulatory expectations successfully, reflecting the strength of the facility’s quality systems (1).

“Securing the [d]rug [m]anufacturing [l]icense not only demonstrates the operational readiness of our Shanghai site but also reflects the strength of our global quality culture,” Stephan Fritschi, CEO of CARBOGEN AMCIS, said in the April 22 press release (1). “This achievement strengthens our long-term goal of becoming a trusted partner in the Chinese pharmaceutical market.”

References

1. CARBOGEN AMCIS. CARBOGEN AMCIS Shanghai Site Awarded Drug Manufacturing License from Chinese NMPA. Press Release. April 22, 2025.
2. CARBOGEN AMCIS. CARBOGEN AMCIS Secures GMP Certification After Successful ANSM Inspection for its Aseptic Drug Product Manufacturing Site. Press Release. March 24, 2025.