CARBOGEN AMCIS Shanghai Site achieves successful outcome in Unannounced NMPA GMP Inspection
China’s NMPA confirms robust GMP compliance at CARBOGEN AMCIS Shanghai, with no observations identified following an on-site unannounced inspection.
BUBENDORF, Switzerland (May 6, 2026) CARBOGEN AMCIS, a Switzerland-based pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, today announces that its Shanghai facility has successfully completed an unannounced Good Manufacturing Practice (GMP) inspection by China’s National Medical Products Administration (NMPA).
The inspection, conducted on 14 April 2026, included an on-site assessment of API manufacturing operations and the site’s Quality System. As part of the unannounced inspection, NMPA inspectors reviewed manufacturing processes, facilities, quality control laboratories, documentation practices and overall quality management systems.
The inspection concluded without observations, and no issues requiring formal explanation were identified. Recommendations were provided to support ongoing continuous improvement.
“This outcome reflects the high level of preparedness and expertise demonstrated by our Shanghai team, as well as the strength and maturity of our Quality System,” said Stephanie Schlienger, V.P. Quality & Compliance, of CARBOGEN AMCIS. “The successful completion of an unannounced inspection with no observations underlines our commitment to maintaining the highest GMP standards across all aspects of our operations.”
The Shanghai facility plays a key role within CARBOGEN AMCIS’ global network, supporting API manufacturing and process development activities. The successful inspection acknowledges the site’s capability to deliver high-quality services in line with international regulatory requirements and supports the company’s continued growth in China and across global markets.
“For the Shanghai site, the significance of this inspection lies in the fact that it was unannounced”, said Simone Maggi, Site Quality Head of CARBOGEN AMCIS Shanghai. “Such inspections test the system as it operates in routine conditions, and this result confirms both the consistency of GMP execution across the site and the readiness and competence of our team.”
Stephan Fritschi, CEO of CARBOGEN AMCIS, added: “Successfully completing an unannounced NMPA inspection with no observations is a significant achievement and a strong validation of our global quality culture. It demonstrates our ability to consistently meet rigorous regulatory expectations and reinforces confidence in our Shanghai site as a reliable partner for our customers worldwide.”
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CARBOGEN AMCIS (carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development, allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is owned by Dishman Carbogen Amcis Limited., Ahmedabad, India.
Dishman Carbogen Amcis Limited (www.imdcal.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Carbogen Amcis group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India.