Carbogen Amcis’ Shanghai facility successfully completed an unannounced good manufacturing practice (GMP) inspection by China’s National Medical Products Administration (NMPA). The comprehensive, on-site assessment of active pharmaceutical ingredient (API) manufacturing operations, and the site’s quality system, happened April 14, 2026.

Carbogen Amcis says the inspection found no critical, major, or minor observations. Additionally, inspectors identified no issues that required formal explanation. Successful completion of the inspection confirmed the robustness of the site’s quality system and operational controls.

Carbogen Amcis Celebrates Achievement

“Successfully completing an unannounced NMPA inspection with no observations is a significant achievement,” said Carbogen Amcis CEO Stephan Fritschi. “[It is] 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.”

According to Carbogen Amcis, its Shanghai facility plays a key role among the company’s global network. It primarily supports API manufacturing and process development activities. Carbogen Amcis says the inspection validates the site’s abilities to deliver high-quality services while adhering to international regulatory requirements.

Good for GMP

Stephanie Schlienger, Carbogen Amcis Vice President of Quality & Compliance, said the outcome reflected a high level of preparedness.

“Successful completion of an unannounced inspection with no observations underlines our commitment to maintaining the highest GMP standards,” Schlienger said.

What NMPA Looked For

Overall, the inspectors reviewed manufacturing processes, facilities, quality control laboratories, documentation practices, and quality management systems. At the close of the inspection, they did provide recommendations to support ongoing continuous improvement. They also highlighted strong subject matter expertise, quick access to documentation, and alignment with regulatory expectations.

Carbogen Amcis, based in Switzerland, offers a portfolio of drug development and commercialization services to the pharmaceutical and biopharmaceutical industries. It is a wholly owned subsidiary of Dishman Carbogen Amcis, headquartered in India.