- CARBOGEN AMCIS announced that its Shanghai facility successfully completed an unannounced GMP inspection by China’s National Medical Products Administration on April 14, 2026.
- The inspection covered API manufacturing operations and the site’s quality systems, concluding without observations or formal findings.
CARBOGEN AMCIS announced that its Shanghai facility has successfully completed an unannounced Good Manufacturing Practice inspection conducted by China’s National Medical Products Administration (NMPA) on April 14, 2026.
According to the company, the inspection included a review of API manufacturing operations, quality systems, manufacturing processes, facilities, quality control laboratories, and documentation practices. CARBOGEN AMCIS stated that the inspection concluded without observations and that no issues requiring formal explanation were identified, although inspectors provided recommendations to support continuous improvement.
The Shanghai site supports process development and Active Pharmaceutical Ingredient manufacturing activities within the company’s global network. The company said the inspection outcome supports its operations in China and international markets while demonstrating compliance with regulatory standards for pharmaceutical manufacturing and contract manufacturing activities.
“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.”
Stephanie Schlienger, Vice President of Quality & Compliance at CARBOGEN AMCIS
The company added that unannounced inspections evaluate routine operating conditions and day-to-day GMP execution. CARBOGEN AMCIS stated that the outcome reflects the readiness of the Shanghai team and reinforces the site’s role as a CDMO partner supporting global pharmaceutical customers.
