CARBOGEN AMCIS Shanghai Facility Achieves Successful Unannounced GMP Inspection from NMPA

CARBOGEN AMCIS Shanghai Facility Achieves Successful Unannounced GMP Inspection from NMPA​

Shanghai, China (May 5, 2026) — The Shanghai facility of CARBOGEN AMCIS (Shanghai) Co. Ltd. has successfully completed an unannounced Good Manufacturing Practice (GMP) inspection by China’s National Medical Products Administration (NMPA). The successful inspection affirms the site's robust compliance with global quality standards.

The NMPA inspection, which took place on April 14, 2026, was comprehensive, encompassing an on-site assessment of the API manufacturing operations and the site's overarching Quality System. During the unannounced review, inspectors thoroughly examined manufacturing processes, facilities, quality control laboratories, documentation practices, and the overall quality management systems in place.

Authorities concluded the inspection without identifying any observations or issues requiring formal explanation. Instead, the review provided recommendations aimed at supporting ongoing continuous improvement.

The successful outcome highlights the preparedness of the Shanghai team and the maturity of the company’s Quality System.

Stephanie Schlienger, V.P. Quality & Compliance of CARBOGEN AMCIS, stated, "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."

For CARBOGEN AMCIS, the Shanghai facility is pivotal to its global operations, supporting both API manufacturing and process development activities within the broader global network. The successful inspection validates the site’s capability to deliver high-quality services in adherence with international regulatory requirements, thereby supporting the company's growth both in China and across global markets.

Simone Maggi, Site Quality Head of CARBOGEN AMCIS Shanghai, emphasized the importance of the timing of the audit, noting, "For the Shanghai site, the significance of this inspection lies in the fact that it was unannounced. 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 that successfully completing the 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."

CARBOGEN AMCIS, a wholly owned subsidiary of Dishman Carbogen Amcis Limited, operates as a leading service provider offering drug development and commercialization services to the pharmaceutical and biopharmaceutical industries. Dishman Carbogen Amcis Limited is a global outsourcing partner for the pharmaceutical industry, providing a full range of development, scale-up, and manufacturing solutions across locations in Europe, China, and India.

DCAL Stock Price Movement​

Shares of Dishman Carbogen Amcis Limited today slipped by 0.11% to settle at ₹186.14. Trading saw the stock navigate a range between ₹182.01 and ₹189.14, supported by a volume of 188,613 shares.